# COMAR Title 10 — Maryland Department of Health ## Subtitle 01 — Procedures ### Chapter 01 — Income Tax Credits for Preceptors in Areas with Health Care Workforce Shortages **Authority:** Tax-General Article, §§10-738, 10-739, 10-739-1, and 10.752, Annotated Code of Maryland **Administrative History:** Effective date: January 29, 2018 (45:2 Md. R. 68) **Administrative History:** Chapter revised effective September 19, 2022 (49:19 Md. R. 868) **Administrative History:** Chapter revised effective March 2, 2026 (53:4 Md. R. 184) #### Regulation .01 Purpose. *COMAR 10.01.01.01* A. The purpose of this chapter is to establish regulatory provisions related to the State income tax credit program for the following qualified health care practitioners who serve as preceptors without compensation in health care workforce shortage areas: (1) Physicians; (2) Advanced practice registered nurses; (3) Physician assistants; (4) Registered nurses; and (5) Licensed practical nurses. B. This chapter describes the procedures used by the Maryland Department of Health to assess eligibility of applicants, process applications, and certify income tax credits for approved applications. #### Regulation .02 Definitions. *COMAR 10.01.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual: (a) Who has submitted an application to the Department requesting State income tax credit; and (b) Whose status for receipt of a tax credit certification has not yet been determined. (2) “Department” means the Maryland Department of Health. (3) “Health Care Practitioner” means an individual who is: (a) A health care practitioner, as defined in Tax-General Article, §10–752, Annotated Code of Maryland; (b) An advanced practice registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland; (c) A registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland; or (d) A licensed practical nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland. (4) “Health care workforce shortage area” means: (a) A health professional shortage area; (b) A medically underserved area; (c) A medically underserved population; (d) Federally designated rural areas; (e) State defined shortage areas; (f) State defined rural areas; or (g) Other areas defined as in need by the Secretary of Health or Governor or as otherwise determined by the Department in consultation with the Governor’s Workforce Development Board. (5) “Income tax credit” means a nonrefundable credit against State income tax. (6) “Preceptor” means a health care practitioner participating in a preceptorship program. (7) “Preceptorship program” has the meaning as stated in Tax-General Article, §§10–738, and 10-752, Annotated Code of Maryland. (8) “Rotation” means a minimum of: (a) 100 hours of community-based clinical training between a: (i) Medical student and a licensed physician preceptor; (ii) Physician assistant student and a licensed physician, nurse practitioner, or physician assistant preceptor in family medicine, general internal medicine, or general pediatrics practice or setting; or (b) 90 hours of community-based clinical training between a: (i) Nurse practitioner student and a licensed physician or nurse practitioner preceptor; (ii) A registered nurse student and an advanced practice registered nurse or registered nurse preceptor; or (iii) A licensed practical nurse student and an advanced practice registered nurse, registered nurse, or licensed practical nurse preceptor. (9) “Taxable year” means the annual accounting period for keeping records and reporting income and expenses that starts on January 1 and ends on December 31 of the same year. #### Regulation .03 Program Eligibility. *COMAR 10.01.01.03* A healthcare practitioner preceptor in a preceptorship program is eligible for an income tax credit if the individual served: A. Without compensation for a minimum of three rotations; and B. In a health care workforce shortage area. #### Regulation .04 Application Procedures. *COMAR 10.01.01.04* A. Applicant. (1) By the published deadlines, on the form designated by the Department, an applicant shall: (a) Submit a complete application to the Department; (b) Facilitate submission of application components by all contributors; and (c) Provide any supporting documentation as requested by the Department. (2) An applicant may voluntarily withdraw the application without prejudice. (3) An applicant may submit a new application subject to §B of this regulation. B. The Department shall receive applications by January 5 for the previous taxable year during which rotations were completed. C. The Department shall: (1) Accept applications received during the application period for Department review; (2) Approve the application if the: (a) Application is complete; (b) Applicant is determined to be eligible; and (c) Funds are available in the appropriate Fund based on precepted student type; (3) Disapprove an application if the application: (a) Fails to provide sufficient information or comply with requested documentation to determine eligibility; (b) Has the appropriate documentation but is determined to be ineligible; or (c) Does not satisfy the requirements established by law or the Department; and (4) Provide the applicant with written notice of the final disposition of the application within 45 calendar days of receipt of an application. D. Appeal of Disapproval of Application. (1) An applicant may appeal the decision to disapprove an application by submitting an appeal request in writing to the Department within 30 calendar days of the date on the notice of the disapproved application. (2) If an applicant submits an appeal, the Department, within 60 calendar days of receipt of the appeal, shall: (a) Sustain or reverse the decision on the application; and (b) Provide written notice to the applicant: (i) Indicating whether the decision on the application has been sustained or reversed; and (ii) Providing an explanation of the decision. (3) An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s disapproval of an application as stated in §D(2) of this regulation. Following receipt of the request, the Department shall follow hearing procedures in accordance with COMAR 10.01.03. (4) Failure to be present for the hearing without prior notice, communication, or approval from the Department may result in: (a) The appeal nullified and decision sustained; (b) The hearing on the appeal not being rescheduled; or (c) Appropriate sanctions as determined by the Department. #### Regulation .05 Verification and Audit of Income Tax Credits. *COMAR 10.01.01.05* A. The Department may: (1) Request from an applicant additional information to verify statements in an application; and (2) Use independent verification, such as a preceptor list and preceptor completion letters received by the medical and nursing schools, to verify information reported on an application for an income tax credit. B. The Comptroller shall retain its audit authority under Tax-General Article, Annotated Code of Maryland. #### Regulation .06 Income Tax Credits. *COMAR 10.01.01.06* A. On approval of an application, the Department shall issue an income tax credit certificate to the approved healthcare practitioner in the amount of $1,000 for each qualifying student rotation for which the healthcare practitioner served as a preceptor. B. Income tax credits shall be issued for the taxable year of the application during which the health care practitioner served without compensation. C. The total amount of an income tax credit allowed for an individual in a taxable year may not exceed the: (1) Maximum credit amount as indicated in Tax-General Article, §§10–738, 10-739, 10-739.1, and 10-752, Annotated Code of Maryland; or (2) State income tax imposed for that individual for that taxable year. D. Any unused amount of an income tax credit for a taxable year may not be carried over to any other taxable year by the preceptor, as referenced in Tax-General Article, §§10–738, 10-739, 10-739.1, and 10-752, Annotated Code of Maryland. #### Regulation .07 Responsibilities of the Comptroller. *COMAR 10.01.01.07* On notification that an income tax credit certificate has been issued by the Department, the Comptroller shall transfer an amount equal to the income tax credit amount stated in the income tax credit certificate from the Nurse Practitioner Preceptorship Tax Credit Fund, the Physician Assistant Preceptorship Tax Credit Fund, or Licensed Practical Nurse and Registered Nurse Preceptorship Tax Credit Fund, to the General Fund. #### Regulation .08 Expiration of Program. *COMAR 10.01.01.08* A. The Department shall issue final income tax credits based on available funds. B. This chapter remains in effect until: (1) The date that funding for income tax credits ceases to be available; or (2) Sunset on June 30, 2030. ### Chapter 02 — Procedures for Public Hearings **Authority:** Health-General Article, §2-104(b), Annotated Code of Maryland **Administrative History:** Effective date: December 1, 1970 **Administrative History:** Chapter revised effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulations .01—.12 repealed and new Regulations .01—.09 adopted effective September 13, 1993 (20:18 Md. R. 1429) #### Regulation .01 Scope. *COMAR 10.01.02.01* A. This chapter applies to hearings the Secretary conducts to gather information from the general public before making a decision or taking an action such as adopting a regulation or issuing a license, certificate, or permit. B. This chapter does not apply to contested case hearings or any hearing where the purpose is other than to gather information from the public at large or from a person with a specific interest in the issue. #### Regulation .02 Definitions. *COMAR 10.01.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Hearing” means a formal meeting, properly published and convened, the sole purpose of which is to gather information from the public at large, or other group or person as required by law, before making a decision or taking an action. (3) “Hearing examiner” means the Secretary of Health or that employee of the Department designated by the Secretary to conduct a specific hearing or hearings. #### Regulation .03 Notice of Hearing. *COMAR 10.01.02.03* A. The Department shall publish a notice of the hearing in the Maryland Register and any other publication required by law. B. The Department shall include in any published or circulated notice of the hearing: (1) The time of the hearing; (2) The place of the hearing, giving the street address, floor, and designated room; (3) The purpose of the hearing; (4) A statement that the Department will make reasonable accommodation for individuals with disabilities if these individuals advise the Department of their special needs by giving the Department reasonable advance notice; and (5) Any other applicable publishing requirements in law. #### Regulation .04 Testimony. *COMAR 10.01.02.04* A. The hearing examiner shall give all persons present who wish to testify an opportunity to do so but may limit repetitious testimony. B. The right of cross-examination is not applicable to hearings under this chapter. C. The hearing examiner may: (1) Allow questions from the audience; (2) Take questions from the audience and redirect the questions to others present at the hearing; (3) Ask questions of anyone present at the hearing; and (4) Refer questions to agency personnel who may respond after the hearing. D. The rules of evidence are inapplicable to hearings under this chapter. E. The hearing examiner shall receive and mark all exhibits offered in testimony if they are relevant to the hearing. #### Regulation .05 Oaths and Affirmations. *COMAR 10.01.02.05* The formality of an oath may be dispensed with unless the hearing examiner believes the oath gives some assurance of veracity, formality, or decorum to the hearing. #### Regulation .06 Conduct and Control of Hearing. *COMAR 10.01.02.06* A. The hearing examiner shall determine the conduct of the hearing, including: (1) The order of presentation; and (2) Time limits for questions and testimony. B. The hearing examiner may: (1) Order a person who engages in disruptive behavior, such as waving a sign or placard or shouting or jeering, that interferes with the orderly conduct of the hearing, to be removed from the hearing; (2) Request police assistance to assure or restore order; and (3) Recess a disorderly hearing. C. Recording, Photographing, Videotaping, Broadcasting, and Televising of Hearings. (1) Except as provided in §C(5) of this regulation, a member of the public, including a representative of the news media, may record a hearing with a tape recorder or other recording device if the: (a) Device does not create excessive noise that interferes with the participation in or the observation of the hearing by a person present; and (b) Recording is done openly so that it is obvious to those in attendance that the hearing is being recorded. (2) Except as provided in §C(5) of this regulation, a member of the public, including a representative of the news media, may photograph, videotape, televise, or broadcast the proceedings of a hearing with a camera if the camera: (a) Is operated without excessively bright or hot artificial light or excessive noise that interferes with the participation in or the observation of the hearing by a person present; and (b) Is used openly so that it is obvious to those in attendance that the hearing is being recorded. (3) The hearing examiner may restrict the movement of a person who is using a recording device, camera, or broadcasting or televising equipment if the restriction is necessary to maintain the orderly conduct of the hearing. (4) Except as provided in §C(5) of this regulation, a member of the public, including a representative of the news media, who is recording, photographing, videotaping, broadcasting, or televising a hearing does not need to obtain the consent of a member of the public at the hearing to do so if the recording, photographing, videotaping, broadcasting, or televising is done openly so that it is obvious to those in attendance. (5) A person who wishes to testify without being photographed, videotaped, or televised or without being recorded by anyone other than the court reporter service or Department may do so by making such a request of the hearing examiner. D. A recording of a hearing made by anyone other than the court reporter service or Department, or a transcript derived from such a recording, is not part of the record of a hearing. #### Regulation .07 The Transcript. *COMAR 10.01.02.07* A. At the Department's discretion, the Department or a court reporter service shall stenographically record verbatim or tape record the hearing. B. If a court reporter service records the hearing: (1) The Department shall arrange for the court reporter service to retain the tape recording or stenographic recording for 1 year following the final decision or action; and (2) A person who desires a copy of the transcript may purchase a copy from the court reporter service. C. If an employee of the Department records the hearing: (1) The Department shall keep the tape recording or stenographic recording with the original of the record; and (2) A person who desires a copy of the transcript may purchase a copy from the Department for a reasonable cost in accordance with COMAR 10.01.08. #### Regulation .08 The Record. *COMAR 10.01.02.08* A. The hearing examiner controls the record. B. The hearing examiner shall assemble a record that consists of all of the following: (1) Exhibits and documents entered into the record, such as: (a) Proposed regulations or applications for licenses, certificates, or permits, (b) Documentation of public notification of the hearing, and (c) Relevant supporting and opposing documentation obtained before, during, and subsequent to the hearing; (2) The register of all persons who attended the hearing including their names, addresses, and any affiliations relevant to the hearing; (3) In accordance with Regulation .07 of this chapter, any: (a) Full or partial transcript of the hearing made or purchased by the Department, and (b) Tape recording or stenographic notes of the hearing made by the Department; (4) A hearing examiner's report consisting of all of the following: (a) A statement of the purpose of the hearing including citations of applicable laws and regulations, (b) An account of the methods of public notification of the hearing, (c) An account of the attendance and conduct of the hearing, (d) A summary of supporting and opposing arguments and analyses of those arguments in light of relevant laws and regulations, (e) Relevant findings such as compliance with law or sufficiency of proposed regulations, and (f) Conclusions and recommendations for a final decision; and (5) The final decision of the decision-making authority. C. Maintenance of and public access to the record is governed by State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland, and by COMAR 10.01.08. D. The Department shall maintain copies of the record as follows: (1) The Office of the Secretary shall maintain the original of the record; and (2) Except for the tape recording or stenographic notes specified in §B(3)(b) of this regulation, the office of the director of the unit concerned shall maintain a copy of the record. #### Regulation .09 Postponement and Continuance. *COMAR 10.01.02.09* The hearing examiner has sole discretion over: A. Postponement or continuance of the hearing; and B. Keeping the record open beyond the date of the hearing. ### Chapter 03 — Procedures for Hearings Before the Secretary of Health **Authority:** Health-General Article, §2-104(b); State Government Article, §§9-1607.2(b) and 10-206(b); Annotated Code of Maryland **Administrative History:** Effective date: July 31, 1973 **Administrative History:** Regulations .01—.10 repealed and new Regulations .01—.38 adopted effective February 6, 1989 (16:2 Md. R. 158) **Administrative History:** Regulations .01—.38 repealed and new Regulations .01—.20 adopted effective April 13, 2015 (42:7 Md. R. 567) #### Regulation .01 Scope. *COMAR 10.01.03.01* A. This chapter applies to hearings that the Secretary is required to conduct by statute or regulation except for those hearings for which specific procedural regulations have been promulgated. This chapter does not apply to conferences, investigations, or proceedings at which the general public has been assembled to provide comments and opinions regarding a permit or license proposed to be issued by the Department, or to hearings before the Department’s Boards and Commissions, which are authorized by law to conduct their own hearings. B. These procedures are intended to supplement the procedures required by law. They are not substantive and are not to be construed as creating rights not set out by law. In the event of conflict, statutory provisions take precedence over this chapter. C. Construction. (1) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this chapter shall be construed, whenever possible, as supplementing COMAR 28.02.01. (2) In a conflict between this chapter and COMAR 28.02.01, this chapter applies. #### Regulation .02 Definitions. *COMAR 10.01.03.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) Civil Penalty. (a) “Civil penalty” means a monetary penalty authorized by statute or regulation and imposed for a violation of a statute, regulation, permit, or license. (b) “Civil penalty” does not include statutorily authorized reimbursement of State or federal expenditures. (2) “Department” means the Maryland Department of Health, or any of its constituent units. (3) “Hearing” means a contested case hearing as defined by the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland. (4) “Administrative Law Judge (ALJ)” means an administrative law judge of the Office of Administrative Hearings as defined in COMAR 28.02.01.02B(1). (5) “Office of Administrative Hearings (OAH)” means the independent unit in the Executive Branch of State government authorized to conduct hearings in contested cases, pursuant to the Administrative Procedures Act and this chapter. (6) “Party” means any person or agency named or admitted as a party, including the Department. (7) “Person” means any individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any firm, partnership, association, corporation, or other entity including any public or municipal corporation and any agency, bureau, department, or instrumentality of federal, State, or local government. (8) “Secretary” means the Secretary of Health, a designee of the Secretary, or that official empowered by statute to render the final agency decision in a contested case. #### Regulation .03 Sanctions. *COMAR 10.01.03.03* This chapter shall be construed to secure the just and speedy determination of each action. If a party fails to follow this chapter, the ALJ or the Secretary may enter such orders in regard to the failure as are just, including limiting the issues to be heard and dismissing the request for hearing or entering an order on the merits against the Department. #### Regulation .04 The Record. *COMAR 10.01.03.04* The record in each case shall include: A. The items listed in COMAR 28.02.01.22B; and B. In the case of a proposed decision: (1) Any exceptions filed by any party; (2) The response to those exceptions; (3) The final decision; and (4) Any correspondence relating to the proposed decision, the exceptions process, and the final decision. #### Regulation .05 Notice of the Right to a Hearing. *COMAR 10.01.03.05* The Department shall provide the notices of agency action and of the right to a hearing required by law. The notices shall contain the information required by State Government Article, §§10-207 and 10-208, Annotated Code of Maryland. #### Regulation .06 Request for Hearing. *COMAR 10.01.03.06* A. A person, either directly or through a representative, may request a hearing by mailing or delivering a written request via U.S. mail, facsimile, or electronic mail to the individual and unit of the Department specified in the notice B. The request shall state that the person desires a hearing in order to review a matter that is the proper subject of a hearing as provided under Department regulations or other applicable law. In addition, the person requesting the hearing shall enclose a copy of the notice of agency action being appealed. C. The request shall include a brief statement of the basis for the request, and other information required by law. D. The Department or constituent unit may require a statement to be made on a form if the person is notified of this requirement and is provided a copy of the form in the notice of the right to a hearing. E. A request for a hearing shall be deemed filed when received in the unit of the Department specified in the notice required by Regulation .05 of this chapter. #### Regulation .07 Delegation. *COMAR 10.01.03.07* A. Contested cases that are authorized by statute to be conducted by the Secretary or the Department shall be conducted by: (1) OAH in accordance with a letter of delegation from the Secretary; or (2) Such other person as authorized by law. B. In all cases delegated to OAH, the delegation is limited to the issues raised by the notice of agency action attached to the transmittal from the agency to OAH. #### Regulation .08 Service. *COMAR 10.01.03.08* When the Department is required to make service, service may be made in any manner reasonably calculated to provide the required notice to the intended recipient. Service upon a party who has applied for a permit, license, or certificate or to whom a permit or license or certificate has been issued by the Department may be made by delivering a copy to the last known address in the Department’s records. #### Regulation .09 Certificates of Service. *COMAR 10.01.03.09* Whenever a party is required by this chapter to serve a copy of a pleading or memorandum upon another party, a certificate shall be appended to the pleading or memorandum stating: A. To whom the copy was sent; B. The address to which the copy was sent; C. The name of the person who sent the copy; and D. The date the copy was sent. #### Regulation .10 Continuances. *COMAR 10.01.03.10* A. On motion or on the Secretary’s own initiative, an exceptions hearing may be continued by the Secretary as justice may require. B. Requests for postponement shall be confirmed in writing, and the written request shall: (1) Set forth the reason for the request; and (2) Unless the parties agree to schedule beyond the 45-day period, list at least three dates within the 45-day period following the day originally scheduled on which the party and counsel would be available for a hearing. (3) Whenever feasible, a postponed hearing shall be rescheduled within the 45-day period. #### Regulation .11 Time Periods. *COMAR 10.01.03.11* For good cause, either the Secretary or the ALJ may shorten, extend, or waive any time periods provided in this chapter. #### Regulation .12 Appointment of Interpreter. *COMAR 10.01.03.12* A. If a party cannot readily hear, speak, or understand the spoken English language, the Secretary may appoint a qualified interpreter to provide assistance during an exceptions hearing. B. Costs of an interpreter may be charged to the party on whose behalf the interpreter is obtained. #### Regulation .13 Appearance of Parties at Hearings; Representation. *COMAR 10.01.03.13* A. A party to a proceeding may be represented by an attorney, or, if allowed by law, appear in person or through another representative. B. Except as otherwise provided by law, a person other than an individual shall be represented by an attorney authorized to practice law in the State. C. Unless the appearance is subsequently withdrawn in writing, any notice, decision, or other matter required to be sent to a party may be sent to the attorney at the attorney’s address. D. When any party is represented by counsel, all submission of evidence, examination, and cross-examination of witnesses, and all objections and motions on its behalf shall be made solely by counsel. #### Regulation .14 Discovery. *COMAR 10.01.03.14* A. Discovery on Request. By written request filed with OAH and served on other parties at least twenty days before the scheduled hearing, a party may require another party to produce, within 15 calendar days: (1) A list of witnesses to be called; (2) Copies of documents intended to be produced at the hearing; and (3) The name and curriculum vitae of any expert who will testify at the hearing. B. Parties are not entitled to discovery of items other than as listed in §A of this regulation. #### Regulation .15 Open Hearings. *COMAR 10.01.03.15* A. Unless otherwise provided by law, documents, notices, and records in the possession of the Secretary as a result of these contested case proceedings may be inspected by any person as provided in State Government Article, §10-611 et seq., Annotated Code of Maryland. B. Cameras and other photographic equipment may be permitted in the exceptions hearing room at the discretion of the Secretary. C. The Secretary may cause the removal of any person whose conduct impedes the orderly progress of an exceptions hearing, or may recess the hearing until such time as it may proceed in an orderly fashion. D. The Secretary may exclude from an exceptions hearing a person or persons who have given the Secretary no advance notice of an intention to attend, if the size of the hearing room is too small to accommodate the presence of that person or persons. E. An exceptions hearing is open to public observation, except for the parts that the Secretary states are to be closed pursuant to a provision of law expressly authorizing that closure. To the extent that a hearing is conducted by telephone, television, or other electronic means, the availability of public observation is satisfied by giving members of the public an opportunity, at reasonable times, to hear the tape recordings, except for such portions of the hearing as are closed pursuant to this section. #### Regulation .16 Burden of Going Forward and Persuasion. *COMAR 10.01.03.16* A. When, by specific statute or regulation, the burden of going forward or the burden of persuasion rests upon a certain party, this regulation does not shift those burdens. B. Except as provided in §A of this regulation: (1) A party requesting a hearing following notice of the Department’s intent to deny or refuse to renew a permit or license bears the burden of going forward to establish a prima facie case of entitlement to the permit or license and the burden of persuasion that the permit or license should be issued; (2) A party contesting the Department’s tentative decision to issue or renew a permit or license bears the burden of going forward to establish a prima facie case that grounds exist for denying the license or permit and the burden of persuasion that the license or permit should be denied; (3) In a proceeding following notice by the Department of an intent to revoke or suspend a permit or license, the Department bears the burden of going forward to establish a prima facie case as to the existence of grounds for revocation or suspension and the burden of persuasion that the license or permit should be revoked or suspended; (4) In a proceeding to impose a civil penalty or to issue an order, the Department bears the burden of going forward to establish a prima facie case as to existence of the grounds for imposition of a civil penalty or issuance of an order and the burden of persuasion that the civil penalty should be imposed or order issued; and (5) In a proceeding in which a party seeks payment from the Department or contests the recoupment by the Department of an alleged overpayment, the party seeking payment or contesting recoupment has burden of going forward and the burden of persuasion. C. Except as provided by §§A and B of this regulation, the party asserting the affirmative of an issue before the ALJ has the burden of going forward and the burden of persuasion. D. A party with the burden of persuasion shall be required to present its case first, unless otherwise agreed by the parties. #### Regulation .17 Final Decision. *COMAR 10.01.03.17* A. The Secretary is not bound by the ALJ’s proposed decision even in those cases where no exceptions are filed. B. If no exceptions have been filed and, after reviewing an ALJ’s proposed decision, the Secretary concludes that the Secretary is unable to approve that decision as written, the Secretary shall notify all parties and invite argument from the affected parties on the issues the Secretary is reconsidering. #### Regulation .18 Exceptions; Requests for Oral Argument. *COMAR 10.01.03.18* A. Exceptions to an ALJ’s proposed decision shall be filed with the Secretary within 21 days after the ALJ’s proposed decision is received. Receipt is presumed to occur 3 days after mailing. B. Exceptions shall be in writing and contain a concise statement as to each portion of the ALJ’s determination to which exception is taken and the asserted basis for taking the exception. C. Any party may file a written response to exceptions taken to the ALJ’s proposed decision within 14 days of the filing of exceptions. D. A copy of the exceptions and any response shall be served on all parties to the proceedings. E. The Secretary shall hear oral argument on the exceptions and may limit the time for oral argument in the discretion of the Secretary. F. The Secretary shall consider the exceptions filed before rendering the final agency decision. G. A party that intends to refer to any evidence produced at the hearing before the ALJ shall notify the agency of the specific evidence in its request for exceptions. That party is responsible for filing with the Secretary a copy of the transcript of the hearing, or relevant portions of it, at that party’s expense, at least 5 days before the scheduled exception hearing. H. If all parties are in agreement, a stipulation of facts may be submitted instead of a transcript. I. Additional evidence may not be introduced, nor may testimony of witnesses be heard by the Secretary. All exception hearings or reviews shall be conducted on the basis of the record compiled before the ALJ. J. Within 90 days after the conclusion of the exceptions hearing, the Secretary shall adopt a final decision and, if appropriate, an order. Copies of the final decision and findings of fact and conclusions of law shall be delivered or mailed promptly to all parties or to their attorneys. #### Regulation .19 Stays. *COMAR 10.01.03.19* A. Except as prohibited by law, a party that is adversely affected by a final order may request a stay of the order from the Secretary pending judicial review. B. A request for a stay shall be filed with the Secretary within 10 days of the date of the final order from which the stay is sought. C. A request shall include a statement of the reasons a stay is sought. D. A request shall include a statement of the grounds for the appeal to the Board of Review or the petition for judicial appeal. E. The Secretary may grant a stay upon such conditions, including security or bond, as the Secretary determines to be proper. F. A request for stay may not operate as a stay, nor extend the time for appeal. G. The Secretary may hold a hearing on a request for a stay, or rule upon the request without a hearing. #### Regulation .20 Judicial Review. *COMAR 10.01.03.20* Unless otherwise agreed between the parties, a party may not file a petition for the judicial review of a decision of the Secretary unless the party has filed exceptions with the Secretary to the proposed decision and the Secretary has rendered a final decision. This provision does not apply when the Secretary has delegated final decision-making authority to OAH. ### Chapter 04 — Fair Hearing Appeals Under the Maryland State Medical Assistance Program **Authority:** Health-General Article, §§2-104 and 15-103, Annotated Code of Maryland **Administrative History:** Effective date: April 1, 1971 **Administrative History:** Regulations .01C, .03C, 04A and C, .05A, .06B and D, .07B, .08, .09, .10 amended effective January 14, 1985 (12:1 Md. R. 16) **Administrative History:** Regulations .04D and .08B amended effective December 14, 1979 (6:25 Md. R. 1980) **Administrative History:** Chapter revised effective March 19, 2012 (39:5 Md. R. 382) **Administrative History:** Regulation .01B amended effective April 15, 2013 (40:7 Md. R. 610) **Administrative History:** Regulation .01B amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); adopted permanently effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .01B amended effective October 22, 2018 (45:21 Md. R. 973); May 18, 2020 (47:10 Md. R. 515) **Administrative History:** Regulation .02 amended effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .02A amended effective April 15, 2013 (40:7 Md. R. 610); May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .02A, B amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .03 amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .03A amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .03B amended effective November 18, 2019 (46:23 Md. R. 1065) **Administrative History:** Regulation .04 amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .04D amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .05A amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .05B amended effective November 18, 2019 (46:23 Md. R. 1065) **Administrative History:** Regulation .06 amended effective November 18, 2019 (46:23 Md. R. 1065) **Administrative History:** Regulation .08B, C amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .08D amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .09C amended effective November 18, 2019 (46:23 Md. R. 1065) **Administrative History:** Regulation .10 amended as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); amended permanently effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .10A amended effective November 18, 2019 (46:23 Md. R. 1065) **Administrative History:** Regulation .12 adopted as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); adopted permanently effective January 6, 2014 (40:26 Md. R. 2162) #### Regulation .01 Definitions. *COMAR 10.01.04.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative law judge” means an individual appointed by the Chief Administrative Law Judge under State Government Article, §9-1604, Annotated Code of Maryland, or designated by the Chief Administrative Law Judge under State Government Article, §9-1607, Annotated Code of Maryland, to adjudicate contested cases at the Maryland Office of Administrative Hearings. (2) “Action by an MCO” means: (a) Denial or limited authorization of a requested service, including: (i) The type or level of service; (ii) Requirements for medical necessity; (iii) Appropriateness; (iv) Setting; or (v) Effectiveness of a covered benefit; (b) Reduction, suspension, or termination of a previously authorized service; (c) Denial, in whole or part, of payment for a service; (d) Failure to provide services in a timely manner; (e) Failure to act within the required time frames; or (f) The denial of an enrollee’s request to dispute a financial liability, including: (i) Cost sharing; (ii) Copayments; (iii) Premiums; (iv) Deductibles; (v) Coinsurance; or (vi) Other enrollee financial liabilities. (3) “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L. 111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L. 112-56). (4) “Appellant” means any individual who requests a fair hearing for the reasons specified in Regulation .02 of this chapter or that individual’s authorized representative. (5) “Authorized representative” has the same meaning as in Regulation .12. (6) “Consolidated Services Center” means a call center operated by the Maryland Health Benefit Exchange to assist consumers who apply for, or participate in, Insurance Affordability Programs offered through the Maryland Health Connection. (7) “Delegate agency” means the: (a) Department of Human Services and its affiliated local departments which, under contractual agreements with the Department, determine initial and continuing eligibility in the Program; and (b) Maryland Health Benefit Exchange and its designated affiliates. (8) “Department” means the Maryland Department of Health, the single state agency which, pursuant to Title XIX of the Social Security Act, implements fair hearing requirements for Program applicants and recipients. (9) “Insurance affordability program” means a program that is one of the following: (a) The Maryland State Medicaid program; (b) The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; (c) A State basic health program established under §1331 of the Affordable Care Act; (d) A program that makes available to eligible individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; and (e) A program that makes available to eligible individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act. (10) “Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI-based insurance affordability programs, including, by delegation, certain eligibility in the Program. (11) “Maryland Health Connection” means the electronic eligibility system maintained by the Maryland Health Benefit Exchange. (12) “MCO” means a managed care organization qualified to participate in the Program under COMAR 10.67.04. (13) “Program" means the Department’s Medical Assistance Program. #### Regulation .02 Opportunity for a Fair Hearing. *COMAR 10.01.04.02* A. An opportunity for a fair hearing shall be granted if: (1) A Program applicant claims their application for Program eligibility is denied; (2) A Program applicant claims that the determination of eligibility received through Maryland Health Connection is incorrect; (3) A Program applicant claims their application for eligibility, or any part thereof, is not acted upon within: (a) 30 days from the date of application to an insurance affordability program; (b) 45 days from the date of application for aged or blind applicants to the Program; or (c) 60 days from the date of application to the Program in the case of determination of disability; (4) A Program recipient asserts their claim for Program services has been erroneously denied or is not acted upon with reasonable promptness; (5) A Program recipient asserts that the Program has acted erroneously; (6) A Program recipient residing in a skilled nursing facility or nursing home asserts that the recipient has been or will be erroneously transferred or discharged; (7) A Program recipient asserts that the Program has made an erroneous decision related to nursing home preadmission and annual review; or (8) A Program participant in an MCO is appealing an action by an MCO and the appeal has been filed within 120 days from the date specified in the notice from the MCO as required by COMAR 10.67.09.05. B. The administrative law judge may not grant a fair hearing if the sole issue is a federal or State law requiring an automatic change adversely affecting some or all Program recipients. #### Regulation .03 Notification of Right to Request a Fair Hearing. *COMAR 10.01.04.03* A. The Program, delegate agency, or MCO shall notify an individual and his or her authorized representative, if previously designated by the individual or recognized as valid by the Program, in writing: (1) Of the right to obtain a fair hearing; (2) Of the method to obtain the hearing; and (3) That the individual may represent himself or use an authorized representative at a fair hearing. B. The notification specified in §A of this regulation shall: (1) Be provided by the Program, the MCO, or the delegate agency when: (a) The individual applies for Program benefits; (b) Any Program, MCO, or delegate agency action affects the individual’s claim to Program benefits; (c) A skilled nursing facility or a nursing facility notifies the individual that the individual is to be transferred or discharged; and (d) The individual receives an adverse determination by the Department or delegate agency with regard to skilled nursing facility or a nursing facility preadmission screening and annual resident review; (2) Include a statement of the action the Program, MCO, skilled nursing facility, or nursing facility intends to take; (3) Include the reasons for the intended action; (4) Include the specific regulations that support, or the change in federal or State law that requires, the action; (5) Include an explanation of the individual’s right to request a fair hearing, including that expenses incurred in connection with a fair hearing, such as transportation and baby-sitting costs, but not including attorney's fees, shall be paid by the Department when incurred by the appellant and may be paid by the Department when incurred by the appellant's witnesses; (6) Include information about fair hearings; (7) Include an explanation of the circumstances under which assistance is continued if a fair hearing is requested, as provided in Regulation .04B of this chapter; (8) Identify who may act as an authorized representative of the appellant in the fair hearing process, explain how an applicant or recipient may designate an authorized representative, and provide information about designation procedures under 10.09.04.12; (9) Specify that the appellant or the appellant’s authorized representative may generally examine the appellant’s records upon reasonable notice to the Program, MCO, or delegate agency; and (10) Except as specified in §C of this regulation, be mailed at least 10 days before the date of action. C. The notice specified in §A of this regulation may be mailed less than 10 days before but not later than the date of action if: (1) The Program has information confirming the recipient’s death; (2) The Program receives a clear written statement signed by a recipient that: (a) The recipient no longer wishes services; or (b) Gives information that requires termination or reduction of services and indicates that the recipient understands that this change in services is the result of supplying that information; (3) The recipient has been admitted to an institution where the recipient is ineligible under the Program for further services; (4) Subject to Regulation .10B(4) of this chapter, the recipient's whereabouts are unknown and the post office returns to the Program or delegate agency mail directed to the recipient indicating no forwarding address; (5) The Program establishes that the recipient has been accepted for Program services by another local jurisdiction, State, territory, or commonwealth; (6) The recipient's physician prescribes a change in the level of care; (7) The notice involves an adverse determination made with regard to preadmission screening requirements; (8) The date of action will occur in less than 10 days and the action involves a long-term care facility’s resident transfer or discharge, in which case the notification shall be made as soon as practicable before transfer or discharge in accordance with 42 CFR §438.12; (9) The Program has facts indicating that action should be taken because of probable fraud by the recipient and the facts have been verified, if possible, through secondary sources, in which case the notification may be mailed 5 days before the date of action; or (10) The action is an eligibility determination, in which case notice shall be given at the same time as the determination. #### Regulation .04 Request for Fair Hearing. *COMAR 10.01.04.04* A. Statement of Request. (1) Any individual, either himself or through an authorized representative, may request a fair hearing by giving a clear statement, oral, electronic, or written, to any member of the Department or delegate agency, that the individual desires an opportunity to present for review any matter which is the proper subject of a fair hearing as provided in Regulation .02 of this chapter. The request shall be made by: (a) Contacting the Program’s Office of Health Services in writing, by telephone or by fax, if the appeal concerns a recipient’s services being denied, suspended, terminated, or reduced; (b) Contacting the Maryland Health Benefits Exchange in writing, by telephone, by email, or by fax, if the appeal concerns an applicant’s eligibility for insurance affordability programs; (c) Contacting the Consolidated Services Center maintained by the Maryland Health Benefit Exchange in writing, by telephone, by email, or by fax, if the appeal concerns eligibility for insurance affordability programs; or (d) Contacting the Office of Administrative Hearings in person, by mail, or by fax, if the appeal concerns the appellant’s eligibility for insurance affordability programs. (2) The Program’s Office of Health Services, the Consolidated Services Center, or the delegate agency that receives the request for a hearing shall assist the appellant or the appellant’s authorized representative in preparing the request. (3) The Program's Office of Health Services, the Consolidated Services Center, or the delegate agency that receives a written statement requesting an appeal shall: (a) Immediately forward an applicant’s statement to the Office of Administrative Hearings; (b) Indicate whether the appeal is for a determination of eligibility under an insurance affordability program or for conventional Medicaid; and (c) Note in its correspondence with the Office of Administrative Hearings if the appeal: (i) Concerns the medical necessity of a denied benefit or service to an MCO enrollee or an application for eligibility insurance affordability programs; (ii) Meets the Program’s criteria for an expedited resolution because the Program has determined that taking the time for a standard resolution could seriously jeopardize the individual’s life or health or ability to attain, maintain, or regain maximum function; and (iii) Must be heard and decided upon within 3 working days after the Office of Administrative Hearings receives the fair hearing request. (4) Appeals of eligibility determinations for insurance affordability programs requested through the Maryland Health Connection shall automatically be transmitted to the Office of Administrative Hearings. (5) If a request for a hearing is made by someone other than the applicant or recipient, the Office of Administrative Hearings shall: (a) Treat the appeal as timely noted if it complies with §D of this regulation unless no documentation is provided on or before the hearing date; (b) Accept appropriate documentation, up to and including the date of the fair hearing, demonstrating that the representative is authorized; and (c) Accept the representation of any member of the bar of Maryland that the individual appellant is his or her client without further documentation. B. Acknowledgement. The Office of Administrative Hearings shall: (1) Promptly acknowledge any request for a fair hearing; (2) Give advance notice in writing of the date, time, and place of the fair hearing; and (3) Provide the appellant with the information specified in Regulation .03B of this chapter. C. Postponements. (1) If any party notifies the Office of Administrative Hearings that either the time or place designated by the Office of Administrative Hearings is not convenient to the party, and requests a different time or place for the fair hearing, the administrative law judge shall designate another time or place convenient to the parties if the administrative law judge deems that the party has sufficient reason for requesting the change. (2) If the appellant is employed during the periods when fair hearings are normally held, the administrative law judge shall attempt to schedule the hearing so that the appellant will not be required to miss employment. D. Timeliness of Appeal. A request for a fair hearing may not be granted unless the request in §A of this regulation is: (1) Postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services within 120 days of the receipt of the notification specified in Regulation .03A of this chapter, if the appeal concerns services provided or denied by an MCO; (2) Postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services within 90 days of the receipt of the notification specified in Regulation .03A of this chapter, if the appeal concerns services provided or denied by the fee-for-service program; or (3) Postmarked, delivered in person, or sent by facsimile to the Office of Administrative Hearings; or emailed to Maryland Health Benefit Exchange; telephoned or faxed to the Consolidated Services Center or postmarked, telephoned, faxed, or delivered in person to the delegate agency within 90 days of the receipt of the notification specified in Regulation .03A of this chapter if the appeal concerns the appellant’s eligibility. E. Dismissal. (1) The Program, the delegate agency, or the Office of Administrative Hearings may dismiss a request for a fair hearing when the appeal has been: (a) Withdrawn in writing addressed to the Office of Administrative Hearings, or in writing, by telephone, or by fax to the Office of Health Services, or in writing, by telephone, or electronically to the Maryland Health Benefit Exchange or other delegate agency, by the appellant or his authorized representative; or (b) Abandoned. (2) An appellant shall be deemed to have abandoned the appellant’s request for a fair hearing if the appellant fails to appear for the fair hearing on the established date without good cause as determined by the administrative law judge. F. Program’s Response. In responding to timely filed requests for a fair hearing, the Office of Administrative Hearings: (1) May respond to a series of individual requests for hearing by conducting a single group hearing; (2) May consolidate hearings only in cases in which the sole issue involved is one of federal or State law or policy; (3) Shall follow the regulations of this chapter governing hearings in all group hearings; and (4) Shall permit each applicant to present the appellant’s own case or be represented by the appellant’s authorized representative. #### Regulation .05 Pre-Hearing Procedures. *COMAR 10.01.04.05* A. A hearing summary shall be prepared containing pertinent information detailing the specific action that is the basis for the appeal. The summary shall be forwarded to the appellant or the appellant’s authorized representative and to the Office of Administrative Hearings at least 6 days before the hearing date. B. The appellant and the Department or MCO may request the names of all witnesses that the other party intends to call at the fair hearing. #### Regulation .06 Hearing Procedures. *COMAR 10.01.04.06* A. The appellant, the Program, the MCO, and the delegate agency shall have the opportunity to: (1) Present witnesses; (2) Present documentary evidence; (3) Present oral and written argument without undue interference; (4) Establish all facts and circumstances the administrative law judge judges to be pertinent; and (5) Question or refute any testimony or evidence, including an opportunity to confront and cross-examine all witnesses the administrative law judge judges to be adverse. B. All parties that wish to call a witness at the hearing shall subpoena the witness in accordance with Office of Administrative Hearings procedures in COMAR 28.02.01.11. The appellant or authorized representative may subpoena any employees of the Department, MCO, or delegate agency whose action is being contested by the appellant or whose testimony may be relevant to the issues under consideration as determined by the administrative law judge. C. Right to Review Record. (1) If the Program, MCO, or delegate agency introduces as evidence documents from the case record, special investigation file, or other sources, the appellant shall have the opportunity to examine the: (a) Persons who prepared the documents; and (b) Case record or special investigation file for the purpose of discovering information favorable to the appellant’s case. (2) Except as specified in Regulation .05A of this chapter, in addition to the rights specified in §C(1) of this regulation and for purposes of defining reasonable notice under Regulation .03B(9) of this chapter, the appellant or the appellant’s authorized representative shall have the opportunity to examine the appellant’s case record or investigation file upon reasonable notice to the Program, the MCO, or the delegate agency as specified in COMAR 07.01.02.04. (3) The Program shall have access to relevant portions of the appellant’s medical record in accordance with Health-General Article, §4-305, Annotated Code of Maryland. D. When a hearing involves a medical issue, such as a diagnosis, an examining physician's report or a medical review team's decision, an additional medical assessment of the appellant's condition shall be obtained and made part of the record if the administrative law judge considers it necessary. Any additional medical assessment shall be made by a person other than the person who made the original medical assessment and shall be obtained at the Department's expense. E. The delegate agency shall be a party to the fair hearing if the fair hearing involves an issue of eligibility. F. Appeal for an Individual Enrolled in an MCO. (1) The parties to the appeal for an individual enrolled in an MCO include the MCO, the enrollee, and the enrollee’s representative or the personal representative of a deceased enrollee’s estate. (2) If the appeal concerns the medical necessity of a denied, reduced, suspended, or terminated benefit or service to an MCO enrollee, and if the fair hearing meets the Department-established criteria for an expedited hearing as provided in Regulation .04A(3)(b)(ii) of this chapter, the Office of Administrative Hearings shall: (a) Schedule the hearing and render a bench decision within 3 working days after the Office of Administrative Hearings receives the fair hearing request; and (b) Issue a follow-up written decision within 30 days of rendering the bench decision if the Office of Administrative Hearings, the appellant or the appellant’s authorized representative, and the MCO agree that a written decision is necessary. (3) All other appeals from MCO decisions shall be: (a) Scheduled for a hearing within 30 days of receipt of the appeal and decided on within 30 days of the hearing; and (b) Otherwise governed by COMAR 10.67.09.05. #### Regulation .07 The Record. *COMAR 10.01.04.07* A. A verbatim recording of the fair hearing shall be made. Nonrecorded or confidential information, which the appellant does not have an opportunity to hear or see, may not be made a part of the hearing record. One transcribed copy of the recording shall be supplied to the appellant at no cost if the appellant takes a further appeal. B. The following shall constitute the exclusive record of the hearing: (1) The transcript or recording of testimony and exhibits, or an official report containing the substance of what happened at the hearing; (2) All papers and requests filed in the proceeding; and (3) The administrative law judge’s decision. C. The recording of testimony shall remain in the custody of the Office of Administrative Hearings for a period not to exceed 2 years, or until all litigation involving the decision is terminated. All other components of the record shall remain in the custody of the Program for a period not to exceed 2 years, or until all litigation involving the decision is terminated. #### Regulation .08 Findings, Timing of Decision, and Effect of Decision. *COMAR 10.01.04.08* A. Findings. (1) The administrative law judge shall: (a) Prepare a written summary of findings and conclusions based exclusively on the record; and (b) Make a decision based on his findings and conclusions. (2) The summary of findings and conclusions shall: (a) State the evidence, policies, regulations, or laws upon which the administrative law judge's decision is based; and (b) Provide written notice to the appellant that, if they are not satisfied with the decision, they may seek additional appeals as specified in §C of this regulation. B. Timing of Hearing Decision. (1) If the appellant is not enrolled in an MCO, the administrative law judge shall forward to the appellant a copy of the findings, conclusions, and decision within 90 days from the earlier of the following: (a) The date the appellant postmarked, delivered in person, or sent by email or facsimile to the Office of Health Services a request for a fair hearing pursuant to Regulation .04D(1) of this chapter; (b) The date the appellant postmarked, delivered in person, or sent by facsimile to the Office of Administrative Hearings or the delegate agency a request for a fair hearing pursuant to Regulation .04D(2) of this chapter; (c) The date the appellant emailed, postmarked or delivered in person to the Maryland Health Benefit Exchange a request for a fair hearing pursuant to Regulation .04D(2) of this chapter; or (d) The date the appellant called or sent by facsimile to the Consolidated Services Center a request for a fair hearing pursuant to Regulation .04D(2) of this chapter. (2) If the appellant is enrolled in an MCO, the administrative law judge shall forward to the appellant or the appellant’s authorized representative a copy of the findings, conclusions, and decision within: (a) 3 working days after the Office of Administrative Hearings receives the fair hearing request if the appeal concerns the medical necessity of a denied benefit or service, and the hearing that meets the criteria, as determined by the Department, for an expedited hearing as provided in Regulation .04A(3)(b)(ii) of this chapter; or (b) 30 days of the hearing if the appeal does not concern the medical necessity of a denied benefit or service. (3) If the date of the fair hearing is postponed at the appellant's request, the length of the postponement may not be counted as part of any of the time periods specified in §B(1) or (2) of this regulation. C. Appeal Rights. (1) Any party may seek administrative review of the administrative law judge’s decision as provided in Health-General Article, §§2-206 and 2-207, Annotated Code of Maryland, and subsequent judicial review as provided in State Government Article, §10-215, Annotated Code of Maryland, except if the appeal is solely of a decision of the Maryland Health Benefit Exchange, in which case any party may seek judicial review as provided in State Government Article, §10-215, Annotated Code of Maryland. (2) An administrative law judge’s decision adverse to the appellant shall be implemented immediately. (3) To the extent an administrative law judge’s decision upholds the determination of the Maryland Health Benefit Exchange with respect to an applicant for an insurance affordability program described in Regulation .01B(9)(a)—(e), the applicant may appeal to the United States Department of Health and Human Services. D. Effect of Decision. (1) When the decision requires action by the delegate agency, that agency shall notify the Program of its compliance with the decision. (2) When the decision is favorable to the appellant, or when the Department, Program, or delegate agency grants the appellant the relief the appellant requests before the decision, the Department, Program, or delegate agency, where applicable, shall: (a) Authorize corrected payments or relief retroactive to the date the incorrect action was taken; and (b) If appropriate, provide for admission or readmission of the appellant to a facility. (3) Any payment or action by the Department, Program, or delegate agency in §D(2) of this regulation may not constitute a waiver of the Department’s, Program’s or delegate agency’s sovereign immunity from suit. (4) When the decision is favorable to the appellant and is an MCO service, the MCO shall authorize or provide the disputed services no later than 72 hours from the date it receives notice reversing the MCO’s determination. #### Regulation .09 Confidentiality. *COMAR 10.01.04.09* A. If the appellant waives in writing his privilege of confidentiality as to the fair hearing, the administrative law judge shall permit members of the public to attend the hearing. B. The administrative law judge may cause the removal of any member of the public whose conduct impedes the orderly progress of the hearing, or recess the hearing until it may proceed in orderly fashion. C. The administrative law judge may exclude from the hearing individuals who have not given the Department or MCO advance notice of their intention to attend if the size of the hearing room is too small to accommodate them. #### Regulation .10 Benefits During Appeals Process. *COMAR 10.01.04.10* A. Benefits Pending Outcome of the Hearing. (1) The Program may terminate or reduce services effective as of the date specified in the notice if the Program timely mails the notice as required under Regulation .03 of this chapter and: (a) The appellant or the appellant’s authorized representative does not timely request a hearing in accordance with Regulation .04 of this chapter; or (b) The appellant or the appellant’s authorized representative withdraws in writing or abandons a request for a fair hearing. (2) Except as provided in §A(3) of this regulation, the Program may not terminate or reduce services until a decision is rendered after the hearing if: (a) The Program timely mails the notice as required under Regulation .03 of this chapter; and (b) The appellant requests a hearing before the date specified in the notice. (3) The Program may terminate or reduce services before an administrative law judge renders a decision after a hearing if: (a) The administrative law judge determines at the hearing that the sole issue is one of federal or State law or policy, or the request for a fair hearing is withdrawn in writing or abandoned; and (b) The Program includes in the notification required by Regulation .03 of this chapter that services are to be terminated or reduced pending the hearing decision. (4) The MCO shall continue benefits pending the outcome of the State fair hearing as described in COMAR 10.67.09.05F. B. Reinstating Benefits. (1) If the Program terminates or reduces services pursuant to §A of this regulation, the Program may reinstate services if a Program recipient requests a hearing not more than 10 days after the date specified in the notice. (2) The reinstated services shall continue until a hearing decision, unless, at the hearing, the administrative law judge determines that the sole issue is one of federal or State law or policy. (3) The Program shall reinstate and continue services until a decision is rendered after a hearing if: (a) Action is taken without the advance notice being given to the recipient as required by Regulation .03 of this chapter; (b) The recipient requests a hearing within 10 days of the mailing of the notice; and (c) The Program determines that the action resulted from other than the application of federal or State law or policy. (4) If a recipient's whereabouts are unknown, as indicated by the return of unforwardable Program mail directed to the recipient, any discontinued services shall be reinstated if the recipient’s whereabouts become known during the time the recipient is eligible for services. (5) The administrative law judge may provide for an additional period during which time the request for a fair hearing will result in reinstatement of a recipient’s assistance to be continued until the hearing decision. #### Regulation .11 Applicability of Regulations. *COMAR 10.01.04.11* If a conflict exists between this chapter and the Rules of Procedure of the Office of Administrative Hearings in COMAR 28.02.01, this chapter shall govern. #### Regulation .12 Authorized Representatives. *COMAR 10.01.04.12* A. Definitions. (1) “Authorized representative” means an individual or organization acting responsibly on behalf of the applicant or recipient in accordance with §§B, C, D, and E of this regulation, in assisting with an applicant or recipient’s application, renewal of eligibility, appeals, and other ongoing communications with the agency. (2) “Signature” includes electronic, including telephonically recorded, signatures and handwritten signatures transmitted by facsimile or other electronic transmissions. B. Designating an Authorized Representative. (1) An applicant or recipient may designate any individual or organization to serve as an authorized representative. (2) An authorized representative may be designated either: (a) In writing, including the applicant or recipient’s signature; or (b) By providing proof of legal authority to act on behalf of an applicant or recipient. (3) Legal authority includes, but is not limited to those who are the: (a) Applicant or, if applicant or recipient is a minor, recipient’s parent; (b) Applicant or recipient’s legal guardian, if one has been appointed, or a person who has in good faith filed an application to be appointed the applicant or recipient’s legal guardian but who has not yet been appointed the applicant or recipient’s legal guardian; (c) Applicant or recipient’s healthcare surrogate as defined in Health General Article, §5-605, Annotated Code of Maryland; (d) Personal representative of the applicant or recipient’s estate, or a person who has in good faith filed an application to be appointed the personal representative of the applicant or recipient’s estate but who has not yet been appointed the personal representative of the applicant or recipient’s estate; (e) Individual appointed to make legal or medical decisions on behalf of the applicant or recipient pursuant to a validly executed power of attorney; or (f) Attorney or paralegal retained by the individual. (4) For individuals who lack the capacity to designate an authorized representative and for whom no other individual or organization has the legal authority to act under §B(2) of this regulation, an authorized representative can be any individual or organization acting responsibly on behalf of the applicant or recipient who: (a) In good faith, is acting in the best interest of the applicant or recipient; and (b) Declares the applicant or recipient lacks legal capacity, and for organizations, declares that its directors, employees, officers or employers, if any, do not have a direct financial interest in the outcome of the fair hearing. (5) For individuals who lack the capacity to designate an authorized representative, for whom no other individual or organization has the legal authority to act under §B(2) of this regulation, and on behalf of whom no individual or organization covered by §B(4) of this regulation is willing and able to act, an authorized representative can be any individual or organization with a direct financial interest in the outcome of the hearing or whose employer has a direct financial interest in the outcome of the hearing who: (a) In good faith is acting in the best interest of the applicant or recipient; (b) Declares that the applicant or recipient lacks legal capacity; and (c) Declares that to the best of his or her belief, no other individual or organization is willing and able to act on the applicant or recipient’s behalf. C. Time for Authorization. Designation of an authorized representative or the declarations by an individual or organization required under §B(4) and (5) of this regulation to become an authorized representative can take place at any time, including, but not limited to, the time of application, upon redetermination, upon filing an appeal, and at the appeal hearing. D. Validity of Representation. The power to act as an authorized representative is valid until the applicant or recipient modifies the authorization or notifies the agency that the representative is no longer authorized to act on his or her behalf, or the authorized representative informs the agency that the authorized representative is no longer acting in such capacity, or there is a change in the legal authority upon which the individual or organization’s authority was based. This notice shall be in writing and shall include the applicant or recipient’s signature or the authorized representative’s signature as appropriate. E. Powers of Authorized Representative. Authorized representatives may be authorized to: (1) Sign an application on the applicant’s behalf; (2) Complete and submit an update, a renewal form, or respond to a request for redetermination; (3) Receive copies of the applicant or recipient’s notice and other communications from the agency; and (4) Act on behalf of the applicant or recipient in all matters with the agency including appeals. F. Obligations of the Authorized Representative. An authorized representative: (1) Is responsible for fulfilling all the responsibilities encompassed within the scope of the authorized representation as described in §E of this regulation to the same extent as the individuals the authorized representative represents; and (2) Shall agree to maintain, or be legally bound to maintain, the confidentiality of any information regarding the applicant or recipient provided by the agency. G. Authorized Representatives Through an Organization. A provider, staff member or volunteer of an organization shall sign an agreement that he or she will adhere to the federal regulations governing authorized representatives as laid out in 42 CFR §435.923 or 45 CFR §155.227, or both, as well as relevant State and federal laws concerning conflicts of interest and confidentiality of information. ### Chapter 05 — Board of Review Procedures *Repealed* **Administrative History:** Effective date: October 27, 1972 **Administrative History:** Regulation .01D amended effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .04 amended effective August 3, 1981 (8:15 Md. R. 1306); February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .07 amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulations .01—.09 repealed and new Regulations .01—.10 adopted effective October 15, 2001 (28:20 Md. R. 1782) **Administrative History:** Chapter repealed effective July 2, 2018 (45:13 Md. R. 664) ### Chapter 06 — Fair Hearing Appeals under the Special Supplemental Food Program for Women, Infants, and Children (WIC) **Authority:** Health-General Article, §2-104; State Government Article, §10-215; Annotated Code of Maryland **Administrative History:** Effective date: February 2, 1977 (4:3 Md. R. 146) **Administrative History:** Regulation .01 amended effective November 3, 1978 (5:22 Md. R. 1673); July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .01A amended effective August 22, 1980 (7:17 Md. R. 1672) **Administrative History:** Regulation .01E amended effective August 22, 1980 (7:17 Md. R. 1672) **Administrative History:** Regulation .01G amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .02 amended effective November 3, 1978 (5:22 Md. R. 1673); July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .02A amended effective June 26, 1981 (8:13 Md. R. 1138) **Administrative History:** Regulation .02B amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .02C amended effective March 24, 1986 (13:6 Md. R. 682) **Administrative History:** Regulation .03 amended effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .03A amended effective March 7, 1980 (7:5 Md. R. 474) **Administrative History:** Regulation .03B amended effective March 7, 1980 (7:5 Md. R. 474); July 18, 1983 (10:14 Md. R. 1262); March 24, 1986 (13:6 Md. R. 682); January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .03C amended effective August 22, 1980 (7:17 Md. R. 1672); July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .04 amended effective November 3, 1978 (5:22 Md. R. 1673); August 22, 1980 (7:17 Md. R. 1672) **Administrative History:** Regulation .05 amended effective June 26, 1981 (8:13 Md. R. 1138); April 12, 1982 (9:7 Md. R. 711); July 18, 1983 (10:14 Md. R. 1262); October 24, 1983 (10:21 Md. R. 1901) **Administrative History:** Regulation .05C amended effective March 24, 1986 (13:6 Md. R. 682) **Administrative History:** Regulation .07 amended effective November 3, 1978 (5:22 Md. R. 1673); March 7, 1980 (7:5 Md. R. 474); July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .08 amended effective March 7, 1980 (7:5 Md. R. 474) **Administrative History:** Regulation .08D adopted effective July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .08E adopted effective March 24, 1986 (13:6 Md. R. 682) **Administrative History:** Regulation .10A amended effective June 26, 1981 (8:13 Md. R. 1138) **Administrative History:** Regulation .12 amended effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .12A amended effective June 26, 1981 (8:13 Md. R. 1138) **Administrative History:** Regulation .12B amended effective April 12, 1982 (9:7 Md. R. 711) **Administrative History:** Regulation .12C amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .14 amended effective March 7, 1980 (7:5 Md. R. 474) **Administrative History:** Regulation .14A amended effective July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .14B amended effective July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .14C amended effective March 24, 1986 (13:6 Md. R. 682) **Administrative History:** Regulation .14D adopted effective July 18, 1983 (10:14 Md. R. 1262) **Administrative History:** Regulation .14E—H adopted effective March 24, 1986 (13:6 Md. R. 682) **Administrative History:** Regulation .15 adopted effective November 3, 1978 (5:22 Md. R. 1673) #### Regulation .01 Definitions. *COMAR 10.01.06.01* A. “Appellant” means an individual, an applicant agency, a food vendor, or delegate agency who desires to participate in the WIC Program, who requests a fair hearing for the reasons specified in Regulation .02, of this chapter. B. “Applicant agency” means a public or private, non-profit health or welfare agency providing or contracting to provide health services, which has filed with the Department all the information required by the Department to apply to participate in the WIC Program. C. “Delegate agency” means a local agency or organization which, pursuant to contractual agreements with the Department, has accepted responsibilities under the WIC Program as defined by federal program regulations. D. “Department” means the Maryland Department of Health. E. “Food vendor” means an individual or organization licensed to sell food products, who has, or has applied to have, a contractual agreement with the Department or delegate agency to supply approved foods to program recipients. F. “Hearing officer” means an impartial official designated by the Secretary of Health to conduct and make administrative decisions in fair hearings. The hearing officer may not have had any prior connection with the action which is the subject of the fair hearing. G. “Participant” means pregnant women, breastfeeding women, post-partum women, infants, and children who are receiving supplemental foods or food instruments (benefits) under the WIC Program, and the breastfed infants of participant breastfeeding women. H. “State Agency” means that unit of the Maryland Department of Health which is responsible for the administration and operation of the WIC Program in Maryland. I. “WIC” means the Special Supplemental Food Program for Women, Infants, and Children, a federally funded program authorized under an amendment to the Child Nutrition Act of 1966 (PL 94-105) to provide supplemental nutritious food as an adjunct to good health care during critical times of growth and development to prevent the occurrence of health problems. #### Regulation .02 Opportunity for a Fair Hearing. *COMAR 10.01.06.02* A request for a fair hearing shall be granted in the following cases: A. An individual's application for participation in the WIC Program is denied by the Department or delegate agency; B. An eligible participant is required to pay the cash value of improperly issued benefits, or is denied benefits, suspended or terminated from the WIC Program by the Department or delegate agency; C. An applicant agency, delegate agency, or food vendor's: (1) Application to participate in the WIC program is denied by the State or local agency, (2) Participation in the WIC program is suspended or terminated by the State or local agency, (3) Participation in the WIC program is affected by any other adverse action by the State or local agency. #### Regulation .03 Notification of Right to Request a Fair Hearing. *COMAR 10.01.06.03* A. Written notification of the right to obtain a fair hearing shall be given by the Department or delegate agency to each appellant at each time of application. B. Written notification of the right to obtain a fair hearing, and the method of obtaining the hearing, shall be given by the Department or delegate agency whenever it notifies an appellant that it intends to recover the cash value of the improperly issued benefits or to deny, suspend, or terminate participation in the WIC Program. If benefits or eligibility for an individual or food vendor are to be denied, suspended, or terminated, written notice shall be mailed or given at least 15 days before the effective date. In the case of a delegate agency, the notice shall be provided 60 days in advance of the effective date. This notification is not required at the expiration of a certification period. C. The notification specified in §B, of this regulation, shall give the appellant the following information: (1) The reason for the action which may adversely affect him or his benefits; (2) The matters which are the proper subject of a fair hearing as provided in Regulation .02, of this chapter; (3) Any positions or arguments on his behalf may be presented personally or by a representative such as a relative, friend, or legal counsel; (4) The circumstances under which assistance is continued if a fair hearing is requested, as provided in Regulation .02, of this chapter. #### Regulation .04 Request for Fair Hearing. *COMAR 10.01.06.04* An appellant, either himself or through a representative, may request a fair hearing by giving a clear statement, oral or written, to any member of the State WIC Staff or delegate agency, that he desires an opportunity to present for review any matter which is the proper subject of a fair hearing as provided in Regulation .02, of this chapter. The statement shall be forwarded immediately to the hearing officer. The State WIC staff or delegate agency to whom a request for a hearing is made shall assist the appellant in submitting and processing the request. #### Regulation .05 Acknowledgement of Request. *COMAR 10.01.06.05* A. The Department shall promptly acknowledge a request for a fair hearing and conduct it within 3 weeks from the date the Department received the request for a hearing. B. The appellant shall be given notice, in writing, at least 10 days before the date of the fair hearing. C. The notification specified in §B, of this chapter, shall include the following information: (1) The date, time, and place of the fair hearing; (2) His right to be represented by a lawyer or other person of his choice during the fair hearing process; (3) His right to present witnesses and documents in his behalf at the fair hearing; (4) A summary of rules for a fair hearing. #### Regulation .06 Redesignation of Time and Place for Hearing. *COMAR 10.01.06.06* If a party notifies the Department that either the time or place designated by the Department is not convenient and requests a different time or place for the fair hearing, the hearing officer shall designate another time or place convenient to the parties, if he considers that the party has sufficient reason for requesting the change. If the appellant is employed during the periods when fair hearings are normally held, the hearing officer shall schedule the hearing so that the appellant will not be required to miss employment. #### Regulation .07 Period of Time for Requesting Hearing. *COMAR 10.01.06.07* A request for a fair hearing may not be granted unless it is made within 60 days from the date the notification specified in Regulation .03, of this chapter, is mailed or given to the appellant, or when Regulation .03, of this chapter, does not apply, within 60 days following the conclusion of the action or inaction which is the subject of the appeal. #### Regulation .08 Dismissal of Request for Hearing. *COMAR 10.01.06.08* The Department may dismiss a request for a fair hearing if: A. It has been withdrawn in writing by the appellant or his representative; B. The appellant or his representative fails, without good cause, to appear at the scheduled hearing; C. The appellant or his representative does not respond within 10 days to a Department letter asking whether he wishes to withdraw his request for a fair hearing; D. The request is not made within the time limits specified in Regulation .07, of this chapter; or E. The appellant has been denied participation by a previous hearing and cannot provide evidence that circumstances relevant to program eligibility have changed in such a way as to justify a hearing. #### Regulation .09 Pre-Hearing Procedures. *COMAR 10.01.06.09* A. The Department shall prepare a hearing summary containing pertinent information respecting the specific action or inaction which is the basis for the appeal. The summary shall be forwarded to the appellant or his representative at least 6 days before the hearing date, and shall include notification that the appellant or his representative may examine documents and records to be used at the hearing at the office of the hearing officer, at a reasonable time before the date of hearing. B. The appellant and the Department may request the names of all witnesses that the other party intends to call at the fair hearing. #### Regulation .10 Hearing Procedures. *COMAR 10.01.06.10* A. The fair hearing procedures may not be unduly complex or legalistic. The hearing official shall administer oaths or affirmations as required by the State. The appellant, the Department, and the delegate agency shall have the opportunity to present witnesses, documentary evidence, and oral and written argument, and to cross-examine all adverse witnesses. The appellant will have the opportunity to advance arguments without undue interference. B. If the appellant wishes to call as witnesses employees of the Department or delegate agency whose action or inaction is being contested by the appellant, or whose testimony, in the judgment of the hearing officer, is relevant to the issues under consideration, the hearing officer shall require their presence at the fair hearing, provided that, when the appellant has knowledge of the names or other identifying description of these employees before the fair hearing, he shall supply the hearing officer with the names or other identifying descriptions at least 3 days before the fair hearing. C. If the Department or delegate agency introduces documents as evidence, the appellant shall have the opportunity to examine persons who prepared the documents and to examine the case record or special investigation file for the purpose of discovering information favorable to his case. D. When the hearing involves medical issues, an additional medical assessment of the appellant's condition shall be obtained and made part of the record if either the hearing officer or the appellant considers it necessary. This additional medical assessment shall be made by a person satisfactory to the appellant other than the person or persons who made the original medical determination, and shall be obtained at the Department's expense. #### Regulation .11 The Record. *COMAR 10.01.06.11* A. A verbatim recording of the fair hearing shall be made. One transcribed copy of the recording shall be supplied to the appellant, at no cost, if the appellant takes a further appeal. The recording, together with all exhibits and papers admitted into evidence, shall constitute the exclusive record for decision. Nonrecorded or confidential information which the appellant does not have an opportunity to hear or see may not be made a part of the hearing record. The written record of the hearing shall be preserved for a period of 3 years and shall be available for examination by the person or his representative at any reasonable time or place during this period. B. The recording and copies of all exhibits and papers shall remain in the custody of the hearing officer for at least 3 years, or until all litigation involving the decision is terminated. #### Regulation .12 Findings, Conclusions, and Decision. *COMAR 10.01.06.12* A. The hearing officer shall prepare a written summary of findings and conclusions based exclusively on the record, and shall state the policies, regulations, or laws upon which the hearing officer's decision is based. The hearing officer's decision shall become a part of the record. B. A copy of the findings, conclusions, and decision shall be forwarded to the appellant or his representative no later than 45 days after the date of receipt of the initial request for a fair hearing; except that, if the date of the fair hearing is postponed at the appellant's request, the length of the postponement may not be counted as part of the 45-day period. The hearing officer further shall provide written notice to the appellant or his representative that if he is not satisfied with the decision, he may seek administrative review as provided in Health-General Article, §2-207, Annotated Code of Maryland, and judicial review as provided in Article 41, §225, Annotated Code of Maryland, or any other provision of law. C. The decision of the hearing officer shall be final and binding upon the Department and the delegate agency, and shall be implemented immediately unless otherwise specifically indicated in the decision, or unless the appellant takes an appeal as provided in Health-General Article, §2-207, Annotated Code of Maryland. However, if the decision being appealed is in favor of a delegate agency seeking to recover the cash value of improperly issued benefits, the delegate agency shall resume its claim collection efforts during pendency of the appeal. When the decision requires action by the delegate agency, that agency shall notify the Department of compliance with the decision. D. The hearing officer shall maintain a copy of the decision, with the name of the appellant and witnesses deleted, in a reference file or hearing decisions that will be accessible to the public. Copies of all decisions, either in full text or in summary form, shall be forwarded to the delegate agency and any agency or physician with which it has contracted to fulfill its program responsibilities and is involved in this fair hearing. #### Regulation .13 Confidentiality as to Fair Hearings. *COMAR 10.01.06.13* If the appellant waives in writing his privilege of confidentiality as to the fair hearings, the hearing officer shall permit members of the public to attend the hearing; however, the hearing officer may cause the removal of any member of the public whose conduct impedes the orderly progress of the hearings, or may recess the hearings until a time when it may proceed in orderly fashion. The hearing officer also may exclude from the hearing persons who have given the Department no advance notice of their intention to attend, if the size of the hearing room is too small to accommodate them. #### Regulation .14 Continuation of Benefits or Participation Pending Hearing Decision. *COMAR 10.01.06.14* A. Whenever an individual, applicant agency, delegate agency, or food vendor is notified of a proposed action as provided in Regulation .03, of this chapter, the proposed action may not be taken unless at least one of the following occurs: (1) A fair hearing is not requested in a timely manner, as provided by Regulation .07, of this chapter; (2) A request for a fair hearing has been withdrawn in writing by the appellant or a representative; (3) The appellant or representative fails, without good cause, to appear at the scheduled hearing; (4) The appellant or representative, after failing to appear at a scheduled hearing, does not respond within 10 days to a departmental letter asking whether the appellant wishes to continue with the appeal; (5) A decision affirming the proposed action of the Department or delegate agency is made by the hearing officer following a fair hearing; (6) The Department has made a determination that the request for a fair hearing is not appropriate as provided for by Regulation .02, of this chapter. B. Whenever an eligible participant is notified during a certification period that benefits are to be denied, suspended, or terminated, those benefits will continue to be provided if the participant requests a fair hearing within the 15 day advance notice period provided by Regulation .03B, of this chapter. Those benefits will continue until one of the conditions specified in Regulation .14A, of this chapter, occurs. C. Whenever an eligible participating food vendor is notified that participation is to be denied, suspended, terminated, or affected by any other adverse action, the food vendor shall be allowed to continue to participate if the food vendor requests a fair hearing at least 10 days before the effective date of the proposed adverse action. Participation shall continue until one of the conditions specified in §A, of this chapter, occurs. D. Applicants who are denied benefits at initial certification or at subsequent certifications may appeal the denial but may not receive benefits while awaiting a hearing. E. An applicant agency or food vendor which is denied participation at time of application may appeal the denial but may not participate while awaiting a hearing. F. Whenever an eligible participant, participating delegate agency, or food vendor requests a fair hearing following the expiration of the time period as provided in §§B and C, of this regulation, the hearing officer, in his discretion, may provide an additional period during which time a request for a fair hearing shall result in continuation of benefits or participation until one of the conditions specified in §A, of this regulation, occurs. G. The adverse action affecting a participating delegate agency shall be postponed until a hearing decision is reached. H. Appealing an action does not relieve a delegate agency or food vendor permitted to continue in the program while its appeal is in process from the responsibility of continued compliance with the terms of any written agreement or contract with the State or local agency. #### Regulation .15 Criminal or Civil Sanctions. *COMAR 10.01.06.15* This fair hearing procedure may not be construed as excluding or replacing any criminal or civil sanctions or other remedies that may be applicable under any federal or State statute or local ordinance. ### Chapter 07 — Petitions for Adoption, Amendment, or Repeal of Regulations **Authority:** State Government Article, §§10-122 and 10-123; Health-General Article, §2-104; Annotated Code of Maryland **Administrative History:** Effective date: November 9, 1981 (8:22 Md. R. 1784) **Administrative History:** Regulation .01B amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .02 amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .04 amended effective December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Regulation .05 amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .06 amended effective January 23, 1989 (16:1 Md. R. 69); December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Regulation .07E amended effective December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Regulation .08 amended effective December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Regulation .09 amended effective December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Regulation .09A amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .10 amended effective January 23, 1989 (16:1 Md. R. 69); December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Chapter revised effective March 2, 2026 (53:4 Md. R. 184) #### Regulation .01 Scope. *COMAR 10.01.07.01* This chapter applies to all petitions submitted to the Department to promulgate, amend, or repeal a regulation over which the Secretary has rulemaking authority in accordance with State Government Article, §10-122, Annotated Code of Maryland.. #### Regulation .02 Definitions. *COMAR 10.01.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Petition” means a petition to promulgate, amend, or repeal a regulation. (3) “Petitioner” means an interested person filing a petition to the Department to promulgate, amend, or repeal a regulation. (4) “Regulation” has the meaning stated in State Government Article, §10-101, Annotated Code of Maryland. (5) “Secretary” means the Secretary of Health. #### Regulation .03 Who May File. *COMAR 10.01.07.03* Any interested person may file a petition requesting the promulgation, amendment, or repeal of any regulation over which the Secretary has rulemaking authority. #### Regulation .04 Form and Submission of Petition. *COMAR 10.01.07.04* A. A petition shall be in writing and include: (1) A detailed description of the regulation which the petitioner requests the Department to promulgate, amend, or repeal; (2) If a request for amendment or repeal, a citation to the affected regulation; (3) A statement in support of the petition; and (4) The petitioner’s: (a) Name; (b) Signature; (c) Address; and (d) Telephone number. B. A petition shall be submitted by the petitioner to the Director of the Department’s Office of Regulation and Policy Coordination via email or U.S. Mail. #### Regulation .05 Disposition and Notification Requirements. *COMAR 10.01.07.05* A. Disposition of Petition. Within 60 days after receipt of a petition, the Secretary shall: (1) Deny the petition; or (2) Initiate rulemaking proceedings. B. Notification Requirements. (1) If the Secretary denies the petition, the Secretary shall provide in writing the reason for denial in accordance with Regulation .06 of this chapter. (2) If the Secretary initiates rulemaking proceedings, the Secretary shall provide in writing notification to the petitioner: (a) Upon the intent to initiate rulemaking proceedings; (b) Upon publication of the proposed action in the Maryland Register; and (c) Upon final disposition through either publication of a notice of final action in the Maryland Register or discontinuation of rulemaking. (3) If the Secretary discontinues rulemaking proceedings the written notification provided to the petitioner in accordance with §B(2) of this regulation shall state the reasons for discontinuation. C. The Secretary shall provide the written notification required under §B of this regulation to any other individual requesting notification. #### Regulation .06 Reasons for Denial of a Petition. *COMAR 10.01.07.06* The Secretary may deny a petition for any reason permitted by law, including, but not limited to: A. That the Secretary does not have the authority to grant the petition; B. That the Department does not have adequate information or resources to evaluate the petition; C. That the Department does not have adequate resources to implement the requested regulation if it is adopted; D. That the Secretary previously adopted a regulation dealing with the same subject matter as that of the petition and rejected the position taken by petitioner at that time, or the petitioner unreasonably failed to make his position known at that time; or E. That the requested regulation change is contrary to or inconsistent with Departmental policy. #### Regulation .07 Rulemaking Proceedings. *COMAR 10.01.07.07* A. Rulemaking proceedings may include any type of action which the Secretary is authorized or required by law to take when promulgating, amending, or repealing regulations, including: (1) Studies to gather information concerning the regulation; (2) Advance notice of proposed rulemaking if the Secretary determines that additional information or public comment is necessary or desirable before a proposed regulation can be formulated; (3) Referral to advisory councils or other official or quasi-official agencies or groups responsible for reviewing the regulation; (4) Proposal of the regulation in the Maryland Register; (5) Reproposal of the regulation if the Secretary determines that, before final adoption, the proposed regulation should be altered and any part of the proposed text differs substantively from its original text; or; (6) Modification of the regulation change either in form or in substance, and either before or after proposal in the Maryland Register, to better reflect the Secretary's responsibilities. B. Despite the initiation of rulemaking proceedings, the Secretary may decide not to promulgate, amend, or repeal the regulation. C. Upon final disposition, the Secretary shall provide the notification required to the petitioner in accordance with Regulation .05 of this chapter. #### Regulation .08 Files of Petitions for Regulations. *COMAR 10.01.07.08* The Department shall maintain a file of all petitions submitted and their disposition. This file shall be available for public inspection in accordance with General Provisions Article, §§4-201—4-206, Annotated Code of Maryland. ### Chapter 08 — Procedures for Access to Records **Authority:** Health-General Article, §2-104(b); State Government Article, §§10-611—10-628; Annotated Code of Maryland **Administrative History:** Effective date: October 12, 1981 (8:20 Md. R. 1635) **Administrative History:** Regulations .01 and .14 amended, .07 and .09 repealed, and new .07 adopted effective July 16, 1984 (11:14 Md. R. 1250) **Administrative History:** Regulation .02B amended effective July 16, 1984 (11:14 Md. R. 1250); July 29, 1985 (12:15 Md. R. 1516); May 15, 1989 (16:9 Md. R. 994) **Administrative History:** Regulation .03 amended effective July 29, 1985 (12:15 Md. R. 1516); May 15, 1989 (16:9 Md. R. 994) **Administrative History:** Regulation .04 amended effective May 15, 1989 (16:9 Md. R. 994) **Administrative History:** Regulation .07B amended effective May 15, 1989 (16:9 Md. R. 994) **Administrative History:** Regulation .07-1 adopted effective July 29, 1985 (12:15 Md. R. 1516) **Administrative History:** Regulation .08 amended effective May 15, 1989 (16:9 Md. R. 994) **Administrative History:** Regulation .14A amended effective August 17, 1992 (19:16 Md. R. 1473) **Administrative History:** Regulation .14G amended effective May 15, 1989 (16:9 Md. R. 994) **Administrative History:** Chapter revised effective December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Regulation .03C amended effective August 18, 2014 (41:16 Md. R. 945) **Administrative History:** Regulation .04A amended effective February 18, 2002 (16:9 Md. R. 220) #### Regulation .01 Scope. *COMAR 10.01.08.01* A. This chapter establishes the procedures for requesting and gaining access to records and information of the Maryland Department of Health , its administrations, and its facilities. B. This chapter does not apply to requests for medical records of individuals, which are governed by Health-General Article, §4-301 et seq., Annotated Code of Maryland, or to requests for drug and alcohol treatment records of individuals, which are governed by Health-General Article, §8-601, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.01.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means any person or governmental unit requesting disclosure of public records. (2) “Department” means the Maryland Department of Health. (3) “Official custodian” means the Secretary of Health or the Secretary's designee. (4) “Secretary” means the Secretary of Health. (5) “Working day” means every day except Saturdays, Sundays, and official State holidays. #### Regulation .03 Procedures Regarding Inspection or Copying of a Record. *COMAR 10.01.08.03* A. To obtain access to records of the Department, an applicant shall submit to the custodian a written application containing the applicant's name, address, telephone number, if available, and a description of the record sought. If the applicant is an individual with a disability, the Department may arrange for an alternative. B. Upon receipt of an application, the custodian shall follow the procedures stated in State Government Article, §§10-614—10-619, Annotated Code of Maryland. C. Response to Requests. (1) The custodian shall respond to a record request as soon as possible, but not later than 10 business days after the receipt of the request, by: (a) Providing access to the requested records; (b) Denying access to the record or parts of the record with an explanation for the denial; or (c) Advising that additional time is needed because the request: (i) Is for voluminous records; (ii) Requires legal advice; or (iii) A record is in storage or archived. (2) If a requested record has been destroyed or lost, the custodian shall notify the applicant of this fact within 10 working days of the request and shall explain in the response the circumstances of the destruction or loss. (3) If access cannot be provided within 10 business days, the custodian shall: (a) Cite the reasons why more time is needed; and (b) Provide a good-faith estimate of how much additional time is required to fulfill the request. D. Time and Place of Inspection. (1) An applicant may inspect a record between 8 a.m. and 5 p.m. on a working day. (2) Inspection takes place where the document is located, unless the custodian determines that another location is more suitable. (3) The custodian shall arrange for a suitable location and method of inspection for an individual with a disability. #### Regulation .04 Fees. *COMAR 10.01.08.04* A. Fee Schedule. (1) Copies. (a) When copies are reproduced using a computer printer or copier machine, the charge for each copy is 50 cents per page. (b) For duplication of other storage media such as compact disks, magnetic tapes, zip disks, floppy disks, memory cards, microfilm, blueprints, drawings, and similar items the charge for reproduction is the actual cost to the Department. (c) For preprinted material that is disseminated by the Department to the public, there is no charge or the charge is the same as that charged to the general public. (d) For records that cannot be copied by the Department and that are copied outside the Department, the charge for reproduction is the actual cost to the Department. In the alternative, the custodian may arrange for the applicant to pay the charges directly to the entity that copies the record. (2) Certification of Copies. The additional charge for each copy certified as a true copy of the original is 20 cents per page. (3) Employee Time. Except for the first 2 hours which are free, the standard charge for responding to requests for public information is $25 per hour of employee time. Employee time to respond to a request may include time searching for records, preparing records to be copied, copying records, and any other similar tasks. (4) Mailing. The charge for mailing or delivery is the actual cost to the Department. B. Estimated Charges. Before reproducing a record, the custodian shall provide the applicant with an estimate of the charge for reproduction and any other costs, and obtain agreement from the applicant that the charges will be paid. The custodian may demand prepayment of the estimated charges before reproducing the record. C. Waiver of Charges. The custodian may waive charges for: (1) Advocacy groups; (2) Medicaid and WIC recipients; or (3) Applicants who demonstrate need and good cause. ### Chapter 09 — Procedures for Hearing Before the Hospital Appeal Board and Nursing Home Appeal Board **Authority:** Health-General Article, §15-108, Annotated Code of Maryland **Administrative History:** Effective date: January 16, 1984 (11:1 Md. R. 43) **Administrative History:** Regulation .01 amended effective June 19, 2006 (33:12 Md. R. 997); July 2, 2018 (45:13 Md. R. 664) **Administrative History:** Regulation .03 amended effective June 19, 2006 (33:12 Md. R. 997) **Administrative History:** Regulation .05A, B amended effective June 19, 2006 (33:12 Md. R. 997) **Administrative History:** Regulation .06A amended effective July 2, 2018 (45:13 Md. R. 664) **Administrative History:** Regulation .06A, D amended effective June 19, 2006 (33:12 Md. R. 997) #### Regulation .01 General. *COMAR 10.01.09.01* This chapter sets out the procedures for appeals of final cost settlements before the Hospital Appeal Board, pursuant to COMAR 10.09.92.10, 10.09.93.12, and 10.09.95.12, and the Nursing Home Appeal Board, pursuant to COMAR 10.09.10.34. #### Regulation .02 Definitions. *COMAR 10.01.09.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Hospital Appeal Board or the Nursing Home Appeal Board. (2) “Final cost settlement” means a determination by the Medical Assistance Program of any amounts due to or owed by a participating provider and includes the results of cost verifications and desk reviews. (3) “Party” means a hospital or nursing home or the Medical Assistance Program. #### Regulation .03 Notice of Appeal. *COMAR 10.01.09.03* A. An opportunity for a hearing shall be provided to any hospital or nursing home that requests review of a final cost settlement by filing a written notice of appeals with the Board not later than 30 days after receipt of the notice of final cost settlement. This notice shall be filed in a format prescribed by the Board. B. The notice of appeal shall be delivered in person to the Board at the address designated by the notice of final cost settlement or shall be sent by registered or certified mail, return receipt requested. C. The notice of appeal shall describe with specificity the particular cost adjustments appealed by the provider as well as the fiscal years in which those adjustments have been applied. D. The provider may elect one of the following types of procedures: (1) The consideration by the Board solely of written material submitted by the provider and the Medical Assistance Program, or its designee, and upon which the Board shall render a decision. The Board may establish time limits within which the material is to be submitted. (2) The consideration by the Board of written material submitted by the provider and the Medical Assistance Program, or its designee, and brief, informal oral arguments. Each party may submit oral arguments by not more than two persons. Formal testimony, swearing in, or witnesses or recording of proceedings may not take place. The Board shall render a decision based upon the written materials submitted and the oral arguments presented. (3) A full evidentiary hearing, including a prehearing conference, in accordance with Regulations .04, .05, and .06 of this chapter. E. The procedures provided in §D(3) of this regulation will be followed if the Medical Assistance Program objects in writing to the election of a procedure provided for in §D(1) or (2) of this regulation within 10 working days of receipt of the election. F. The Board shall prescribe the format in which the provider may elect the type of procedure desired with the submission of an appeal. This election shall be binding and constitutes a waiver of any other form of hearing before the Board for that particular appeal unless the Medical Assistance Program objects in the manner provided in §E of this regulation. #### Regulation .04 Prehearing Conference for Evidentiary Hearing. *COMAR 10.01.09.04* A. After receipt of a notice of appeal with an election by the provider of a full evidentiary hearing, the Board shall schedule a prehearing conference. B. The prehearing conference shall be presided over by a member of the Board or by a person designated by the Board. C. The prehearing conference may be conducted either in person or by telephone conference call. D. The presiding officer shall issue a prehearing order after the conference specifying the: (1) Witnesses that each party intends to call, if any. (2) Schedule for any briefs of the issues of fact and law involved in the hearing. These briefs shall be in the form and with the number of copies designated by the presiding officer. (3) Date of the hearing, unless the parties agree to waive an oral hearing. (4) Order in which the parties shall present their case. E. A record shall be made of the prehearing conference by the officer in charge. F. All prehearing matters, including requests for postponements, shall be addressed to and determined by the officer who presides at the prehearing conference. #### Regulation .05 Conduct of the Evidentiary Hearing. *COMAR 10.01.09.05* A. The hearing shall be conducted by the Board, or by a person or agency designated by the Board. B. The rules of evidence in all hearings shall be those set forth in State Government Article, §§10-213 and 10-214, Annotated Code of Maryland. C. Any party may submit evidence, examine and cross-examine witnesses, and file objections, exceptions, and motions. When a party is represented by counsel, all submissions of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by counsel. D. The presiding officer or officers at the hearing may examine any witness called by any party or may call as a witness any persons in attendance at the hearing. E. Testimony taken at the hearing shall be under oath. The oath shall be in the following form: “Do you solemnly promise and affirm under the penalties of perjury that the testimony you are about to give in this matter now pending before the Board shall be the truth, the whole truth, and nothing but the truth?” F. If a party fails to appear at the hearing after due notice, the presiding officer or officers at the hearing may reschedule the hearing, or dismiss the appeal, or may proceed to determine the issues appealed on the available record. G. The presiding officer or officers shall prepare an official record of the hearing which shall include the notice of appeal, the presiding officer or officers' record of the prehearing conference, the prehearing order, a stenographic transcription of any oral evidence presented at the hearing, as well as any pleadings, written testimony, exhibits, and other memoranda or materials filed in the proceedings. #### Regulation .06 Recommendation to the Board. *COMAR 10.01.09.06* A. If the hearing is not conducted before a Board consisting of three members as provided in COMAR 10.09.10.34, 10.09.92.10, 10.09.93.12, and 10.09.95.12, the presiding officer or officers at the hearing shall issue recommendations to the Board on all of the issues appealed in the notice of appeal. B. The recommendations shall be in writing and shall include findings of fact and conclusions of law. C. A copy of the recommendations shall be delivered or mailed promptly to each party or his attorney of record. D. Within 20 days after receipt of the recommendations, any party may file exceptions with the Board from all or a portion of the recommendations and may present argument before the Board as provided in State Government Article, §10-216, Annotated Code of Maryland, or waive oral argument and have the Board proceed only on the party's written exceptions. If exceptions to the recommendations are filed beyond the 20 day limit, these exceptions may not be considered by the Board when making its decision. #### Regulation .07 Decision. *COMAR 10.01.09.07* A. If the hearing was presided over by the full Board, or after consideration by the full Board of the recommendations and exceptions to the recommendations and any argument in support of them, the Board shall issue a decision including findings of fact and conclusions of law on all issues appealed in the notice of appeal. B. The decision of the Board shall be implemented immediately unless otherwise specifically indicated in the decision. #### Regulation .08 Appeal. *COMAR 10.01.09.08* Any party may file an appeal from the decision of the Board as provided by law. ### Chapter 10 — Payment for Off-Grounds Medical Services **Authority:** Health General Article, §2-104(b), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 adopted as an emergency provision effective September 1, 1983 (10:20 Md. R. 1780); adopted permanently effective December 19, 1983 (10:25 Md. R. 2268) **Administrative History:** Regulation .02B amended effective February 20, 1989 (16:3 Md. R. 342) **Administrative History:** Regulation .04D amended effective February 20, 1989 (16:3 Md. R. 342) **Administrative History:** Chapter revised effective December 20, 1993 (20:25 Md. R. 1946) #### Regulation .01 Purpose. *COMAR 10.01.10.01* The Secretary of Health (MDH) has established accounts for the purpose of payment of off-grounds medical services. These accounts are to be used by MDH facilities whose clients receive services from private medical providers that the facility cannot furnish or secure by contract. The care could include laboratory work, services from medical specialties, and acute hospitalization. The care does not include ambulance transportation. #### Regulation .02 Definitions. *COMAR 10.01.10.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Client” means a resident or patient in a Maryland Department of Health facility. (2) “Department” means the Maryland Department of Health. (3) Facility. (a) “Facility” means an inpatient or residential facility owned and operated by the Department. (b) “Facility” includes Mental Administration institutions, Developmental Disabilities Administration institutions, and chronic and rehabilitation facilities. (4) “Medical providers” means private providers of medical care or related services who render care to clients of the Department's facilities. (5) “Off-grounds medical services” means medical care or related services provided to clients of the Department's facilities rendered by medical providers at a site other than the facility. (6) “Secretary” means the Secretary of Health. #### Regulation .03 Requirements. *COMAR 10.01.10.03* A. All facilities shall provide or arrange for the provision of medical care required by individuals placed in Department facilities. B. All facilities shall purchase medical services that cannot be provided in the facility by the facility's staff or visiting consultants from providers appropriately licensed in the state in which the service is to be rendered. C. All facilities shall purchase medical services from medical providers who agree to invoice the facility only for those services that are not covered by third-party payers, including federal, state, or federal-state programs. D. The financial agents shall assist the provider in identifying potential sources of recovery. #### Regulation .04 Payment Procedures. *COMAR 10.01.10.04* A. Medical providers shall collect to the extent possible from third-party payers such as Medical Assistance, Medicare, and private insurers. B. Facilities shall direct medical providers to invoice the facility for the cost of those services not covered by third-party payers. For Medical Assistance recipients, the Secretary or the Secretary's designee shall determine which services are specifically provided for in the facility's budget and are included in the facility's Medical Assistance per diem rate, and, therefore, may not be billed directly to the Maryland Medical Assistance Program. C. The purchase of care agreement entered into with the provider shall state that “The provider, in accepting this client for care, agrees to pursue recovery of the cost of care from all third-party payers and any state, federal, and federal-state program for which this client might be eligible, based on the information furnished by the facility before invoicing (name of facility).” D. Payment in Full. (1) If a third-party source of payment is intended to be payment in full, the facility may accept but may not pay invoices for the service rendered, unless payment by the third-party source is denied. (2) If a third-party source of payment is not intended to be payment in full, the facility shall pay the amount of the bill not paid by the third-party payer. E. Medical providers shall submit all invoices to the appropriate facility within 12 months of the date of services. #### Regulation .05 Recovery and Reimbursement. *COMAR 10.01.10.05* A. If a client has insurance or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the client for any service covered by this chapter, the medical provider shall seek payment from that source. B. Payment. If payment is made by both the facility and insurance or other payer, the following conditions apply: (1) If the facility has paid all or part of the invoice and the third-party payer has made payment that represents payment in full, then the medical provider shall return the facility's entire payment to the facility; (2) If the facility has paid the invoice in full and if the third-party payer has made payment that represents partial payment, then the medical provider shall return the amount of the third-party payment to the facility; (3) If a third-party payer has made payment that is intended to be a partial payment and the facility has paid the remainder, then no repayment to the facility is required. C. The provider shall reimburse the facility for any overpayment. ### Chapter 11 — Correction or Amendment of Public Records **Authority:** Health-General Article, §2-104(b); State Government Article, §§10-613(b) and 10-625; Annotated Code of Maryland **Administrative History:** Effective date: April 8, 1985 (12:7 Md. R. 702) **Administrative History:** Regulation .02 amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .06C amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .10A amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .11 adopted effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Chapter revised effective December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Chapter revised effective August 18, 2014 (41:16 Md. R. 946) #### Regulation .01 General. *COMAR 10.01.11.01* These regulations set out procedures for persons in interest who are authorized to inspect a public record to request the correction or amendment of that public record in the Maryland Department of Health under State Government Article, §10-625, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.01.11.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Person in interest” means: (a) A person or governmental unit that is the subject of a public record, or a designee of the person or governmental unit; (b) If the person has a legal disability, the parent or legal representative of that person; or (c) As to requests for correction of certificates of death under Health-General Article, §5-310(d)(2), Annotated Code of Maryland, the spouse, adult child, parent, adult sibling, grandparent, or guardian of the person of the deceased at the time of the deceased's death. #### Regulation .03 Who May Request. *COMAR 10.01.11.03* A person in interest may request the Department to correct or amend any public record that the person in interest is authorized to inspect pursuant to State Government Article, §10-625, Annotated Code of Maryland. #### Regulation .04 Contents of Request. *COMAR 10.01.11.04* The person in interest shall request the correction or amendment in writing. The request shall: A. Identify the public record the person is seeking to correct or amend; B. State the precise correction or amendment requested; C. State the reason the correction or amendment is sought; and D. Include the statement that the record is, to the person's belief, currently inaccurate or incomplete. #### Regulation .05 Filing the Request. *COMAR 10.01.11.05* A person shall file a request for correction or amendment of the record with the Department by addressing it to the custodian of the record. If the custodian is unknown to the person in interest, the person may address the request to the Secretary of Health. #### Regulation .06 Return of Nonconforming Request. *COMAR 10.01.11.06* A. The Department shall accept a request to correct or amend a public record when it is received if it complies with Regulations .04 and .05 of this chapter. B. If the request does not comply with Regulations .04 and .05 of this chapter, the Department shall return the request to the requester with: (1) An explanation of the reason for the return; and (2) A statement that, on receipt of a request that complies with Regulations .04 and .05 of this chapter, the request will be accepted and considered. #### Regulation .07 Response to Request. *COMAR 10.01.11.07* Within 30 days after the request for correction or amendment is received, the custodian of the record shall: A. Make the requested correction or amendment and inform the person of the action; B. Inform the person in writing of the: (1) Department's refusal to make the requested correction or amendment, and (2) Reason for the refusal; or C. Inform the person in writing that the request will not be acted on because: (1) The person is not a person in interest; (2) The record sought to be corrected or amended is not a public record; (3) The person requesting the correction or amendment is not entitled to inspect the record under State Government Article, §§10-615—10-619, Annotated Code of Maryland; (4) The record in which the change is requested is not in the Department's custody; or (5) Of any other reason that is authorized by law. #### Regulation .08 Refusal of Request. *COMAR 10.01.11.08* If the Department's response under Regulation .07 of this chapter, is to refuse the requested correction or amendment, the person in interest may file with the Department a concise statement of the person's reasons for: A. The requested correction or amendment; and B. Disagreement with the Department's refusal to make the correction or amendment. #### Regulation .09 Requirements for Statement of Disagreement. *COMAR 10.01.11.09* A person who desires to file the statement of disagreement specified in Regulation .08 of this chapter shall file the statement in not more than five, one-sided, 8-1/2 by 11 inch pages. #### Regulation .10 Information Provided to Third Parties. *COMAR 10.01.11.10* When the Department discloses to a third party information from a public record about which a statement in compliance with Regulations .08 and .09 of this chapter has been filed, the Department shall furnish a copy of the statement to the third party. #### Regulation .11 Administrative Review. *COMAR 10.01.11.11* A. A person may request a hearing by filing a request for a hearing with the custodian of the record, if the person has been denied: (1) An amendment or correction of a record; (2) The right to file a statement of disagreement; or (3) The right to have a statement to a third party forwarded pursuant to Regulation .10 of this chapter. B. A person shall file the request for a hearing within 30 days of the date of the denial pursuant to §A of this regulation. C. The custodian of the record shall file immediately the request for a hearing with the Office of Administrative Hearings, which shall conduct the hearing. D. The Office of Administrative Hearings shall conduct hearing proceedings in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and the administrative hearing regulations of the Department and the Office of Administrative Hearings. #### Regulation .12 Judicial Review. *COMAR 10.01.11.12* A person who is aggrieved by the final decision following all administrative review, including the final decision of the Secretary and the decision of the Board of Review, may file for judicial review under State Government Article, §10-222, Annotated Code of Maryland, by filing a petition in the appropriate circuit court. ### Chapter 12 — Declaratory Ruling **Authority:** State Government Article, §§10-301—10-305, Annotated Code of Maryland **Administrative History:** Effective date: June 15, 1987 (14:12 Md. R. 1350) **Administrative History:** Chapter adopted as COMAR 10.01.13 recodified to COMAR 10.01.12 **Administrative History:** Regulation .02C amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Regulation .03B amended effective January 23, 1989 (16:1 Md. R. 69) **Administrative History:** Chapter revised effective April 11, 1994 (21:7 Md. R. 530) #### Regulation .01 Definitions. *COMAR 10.01.12.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Declaratory ruling” means a ruling made by a promulgating authority with respect to the manner in which the promulgating authority would apply a regulation or order of the promulgating authority, or a statute that the promulgating authority enforces, to a person or a property based on a given set of facts. (2) “Department” means the Maryland Department of Health. (3) “Person” means: (a) An individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind; (b) A partnership, firm, association, corporation, or other entity; and (c) A political subdivision of the State or an instrumentality of a political subdivision. (4) “Promulgating authority” means the promulgating authority's designee or an officer or unit of the Department that is authorized by law to adopt regulations subject to State Government Article, §§10-101—10-139, Annotated Code of Maryland, or adjudicate contested cases subject to State Government Article, §§10-201—10-207, Annotated Code of Maryland. #### Regulation .02 Petition. *COMAR 10.01.12.02* A. An interested person may file with the promulgating authority a petition for a declaratory ruling. B. Petition for Declaratory Ruling. The petition for a declaratory ruling shall be filed in writing and shall describe in detail: (1) The interest of the petitioner in making the request; (2) The issues involved; (3) A statement of the facts; (4) A list of documents or statements the petitioner believes should be considered; and (5) A sworn statement by the petitioner that the facts contained in the petition are true to the best of the person's knowledge and belief. #### Regulation .03 Consideration and Disposition. *COMAR 10.01.12.03* A. Consideration and Disposition. The promulgating authority shall: (1) Consider the petition and may issue the declaratory ruling requested; (2) Notify the petitioner in writing of the action decided upon and state the reasons for the decision. B. Publication and Inspection. (1) The promulgating authority shall keep a record of each declaratory ruling issued and index all declaratory rulings issued by reference to statutes or regulations involved. (2) The promulgating authority may publish declaratory rulings of general interest subject to the mandates of the Public Information Act, State Government Article, §10-601 et seq., Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to the Public Information Act. #### Regulation .04 Appeal. *COMAR 10.01.12.04* A declaratory ruling is subject to judicial review as provided in State Government Article, §10-305, Annotated Code of Maryland. ### Chapter 13 — Procedures for Interagency Coordination for Licensing Residential Child Care Facilities **Authority:** Health-General Article, §§2-104(b), 7-714, 7-903, 8-403, 8-404, 10-204, 10-514—10-524, and 10-920—10-926, Annotated Code of Maryland **Administrative History:** Effective date: October 11, 1993 (20:20 Md. R. 1571) #### Regulation .01 Scope. *COMAR 10.01.13.01* An applicant for a license for a residential child care facility or a residential child care program may seek a variance or waiver under this regulation. This chapter applies to licenses regulated by COMAR 10.22.03, 10.22.11, 10.22.14, 10.23.02, and 10.47.01 if the population of the facility is comprised of at least 90 percent children and if they are not regulated by the Health Resources Planning Commission through the Certificate of Need process. #### Regulation .02 Definitions. *COMAR 10.01.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Secretary” means the Secretary of Health. (2) “Variance” means an alternative procedure to satisfy a specific licensing regulation. (3) “Waiver” means the setting aside of a specific licensing regulation. #### Regulation .03 Application for Variance. *COMAR 10.01.13.03* A. An applicant for a license under the chapters listed in Regulation .01, of this chapter, may request a variance to specific licensing regulations. B. An application for a variance shall: (1) Be written; (2) Contain specific details of the alternative procedures proposed by the applicant; and (3) Demonstrate that the alternative procedures proposed shall: (a) Meet or produce the intended effects of each regulation for which the variance is requested and (b) Maintain the health, safety, and well-being of children in the facility at or above the level required by each regulation for which the variance is requested. #### Regulation .04 Department Action on Application for Variance. *COMAR 10.01.13.04* A. Upon consideration of an application for variance, the Secretary may grant the request for a variance, if the: (1) Applicant has submitted an application in accordance with the provisions of Regulation .03 of this chapter; (2) Applicant has complied with all other applicable licensing regulations of the Department; and (3) Secretary determines that the alternative procedure proposed by the applicant shall: (a) Meet or produce the intended effect of the regulation, and (b) Maintain the health, safety, and well-being of children in the facility at or above the level required by the regulation at issue. B. The determination of the Secretary upon the application for variance shall be in writing, and mailed to the applicant within 60 days of the date the application for variance is received by the Department. C. If granted, the variance may remain in effect for the term of the license and may be renewed upon application of the licensee when the license is renewed. #### Regulation .05 Application for Waiver. *COMAR 10.01.13.05* A. An applicant for a license under the COMAR chapters listed in Regulation .01, of this chapter, may request a waiver of specific provisions of licensing regulations. B. An application for a waiver shall: (1) Be written; (2) Contain specific facts upon which the waiver is requested; and (3) Demonstrate that: (a) The waiver is necessary to meet the requirements of any federal child care licensing program; or (b) Enforcement of the regulation for which a waiver is requested is contrary to the purposes of the statute under which the regulations are promulgated, and it would be unduly burdensome and inequitable for the applicant to comply with the provisions of the regulation for which a waiver is requested. #### Regulation .06 Department Action on Application for Waiver. *COMAR 10.01.13.06* A. The Secretary may grant a waiver of provisions of the applicable licensing regulation if the: (1) Applicant has filed a written request for a waiver in accordance with Regulation .05 of this chapter; (2) Waiver is not inconsistent with the purposes and provisions of the statute under which the regulations are promulgated, and the health, safety, and well-being of the children in the facility will not be jeopardized solely by the granting of the waiver; and (3) Applicant has demonstrated the facts required in Regulation .05B(3) of this chapter. B. The determination of the Secretary upon the application for waiver shall be in writing, and mailed to the applicant within 60 days of the date the application for the waiver is received by the Department. C. If granted, the waiver may remain in effect for the term of the license and may be renewed upon application of the licensee when the license is renewed. #### Regulation .07 Appeals. *COMAR 10.01.13.07* An applicant aggrieved by a determination of the Secretary upon an application for waiver or variance may file an appeal of the determination in accordance with the Administrative Procedure Act, State Government Article, §§10-201—10-405, Annotated Code of Maryland, and the Department's regulations governing administrative appeals taken pursuant to the Administrative Procedure Act. ### Chapter 14 — Open Meetings — Attendance and Recording, Photographing, and Broadcasting of Sessions **Authority:** State Government Article, §10-507(b), Annotated Code of Maryland **Administrative History:** Effective date: May 24, 1993 (20:10 Md. R. 851) #### Regulation .01 Definition. *COMAR 10.01.14.01* “Public body” means the entity defined at State Government Article, §10-502(h), Annotated Code of Maryland. #### Regulation .02 Public Attendance. *COMAR 10.01.14.02* A. The general public may attend and observe an open session of a public body within or established by the Maryland Department of Health. B. Except in instances when a public body expressly invites public testimony, questions, comments, or other forms of public participation, or when public participation is otherwise authorized by law, a member of the public attending an open session may not participate in the session. #### Regulation .03 Disruptive Conduct. *COMAR 10.01.14.03* A. Prohibition. An individual attending an open session of a public body may not engage in any conduct, including a visual demonstration such as the waving of a placard, sign, or banner, that disrupts the session or that interferes with the right of a member of the public to attend and observe the session. B. Action to Restore Order. The presiding officer may: (1) Order an individual who engages in conduct prohibited by §A of this regulation, or who violates any other regulation concerning the conduct of an open session, to be removed from the session; (2) Request police assistance to restore order; and (3) Recess the session while order is restored. #### Regulation .04 Recording, Photographing, Videotaping, Broadcasting, and Televising of Open Sessions. *COMAR 10.01.14.04* A. A member of the public, including a representative of the news media, may record an open session of a public body by means of a tape recorder or another recording device, if the: (1) Device does not create an excessive noise that interferes with the participation in a session by a member of the public body or the observation of the session by a member of the public; (2) Device does not otherwise interfere with an individual's observation of or participation in the session; and (3) Recording is done openly so that it is obvious to those in attendance that the session is being recorded. B. A member of the public, including a representative of the news media, may photograph or videotape the proceedings of a public body at an open session by means of a camera if the camera: (1) Is operated without excessively bright artificial light or excessive noise that interferes with the participation of a member of the public body in the session or the observation of the session by a member of the public; (2) Does not otherwise interfere with an individual's observation of or participation in the session; and (3) Is used openly so that it is obvious to those in attendance that the session is being recorded. C. A representative of the news media may broadcast or televise the proceedings of a public body at an open session if the equipment used: (1) Is operated without excessively bright artificial light or excessive noise that interferes with the participation of a member of the public body in the session or the observation of the session by a member of the public; (2) Does not otherwise interfere with an individual's observation of or participation in the session; and (3) Is used openly so that it is obvious to those in attendance that the session is being broadcast or televised. D. The presiding officer may restrict the movement of an individual who is using a recording device, camera, or broadcasting or televising equipment if the restriction is necessary to maintain the orderly conduct of the session. E. A public body may require that an individual, who intends to record, photograph, videotape, broadcast, or televise an open session, register in advance of the beginning of the meeting. #### Regulation .05 Recordings Not Part of the Record. *COMAR 10.01.14.05* A recording of an open session made by a member of the public, or a transcript derived from the recording, is not a part of the record of a proceeding of a public body. ### Chapter 15 — Exemption from Self-Referral Laws **Authority:** Health-General Article, §2-104(b); Health Occupations Article, §1-301 et seq., Annotated Code of Maryland **Administrative History:** Effective date: June 25, 2001 (28:12 Md. R. 1106) **Administrative History:** Regulation .02B amended effective March 30, 2026 (53:6 Md. R. 290) **Administrative History:** Regulation .03B amended effective March 30, 2026 (53:6 Md. R. 290) **Administrative History:** Regulation .05 amended effective March 30, 2026 (53:6 Md. R. 290) **Administrative History:** Regulation .06 amended effective March 30, 2026 (53:6 Md. R. 290) **Administrative History:** Regulation .07 amended effective March 30, 2026 (53:6 Md. R. 290) #### Regulation .01 Scope. *COMAR 10.01.15.01* A. This chapter governs exemptions from the prohibition on self-referral made by the Secretary in conjunction with the Maryland Health Care Commission. B. This chapter creates the means by which the Secretary and the Maryland Health Care Commission can determine whether: (1) A health care practitioner's beneficial interest is essential to finance and to provide a health care entity; and (2) The health care entity is needed to ensure appropriate access for a community to the services provided by the health care entity. C. This chapter interprets certain definitions and terms used in the statute for the purpose of enforcement by the licensing boards of the Maryland Department of Health. #### Regulation .02 Definitions—Applicable to Health Occupations Article, §1-301 et seq., Annotated Code of Maryland. *COMAR 10.01.15.02* A. For the purpose of enforcing Health Occupations Article, §1-301 et seq., Annotated Code of Maryland, the following terms have the meanings indicated. B. Terms Defined. (1) “Group practice” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. (2) Health Care Service. (a) “Health care service” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. (b) “Health care service” includes but is not limited to: (i) Supplies; (ii) Drugs; and (iii) Items furnished to a patient by a health care entity.. (3) “Members of the group” means health care practitioners: (a) With an ownership interest in the group practice; or (b) Who are full-time or part-time contractors or employees during the time they furnish services to patients of the group practice that are furnished through the group and are billed in the name of the group. (4) “Patient care services” means the total patient care time spent on any task performed by a group practice member that addresses the medical needs of specific patients, regardless of whether they involve direct patient encounters, and including but not limited to time spent: (a) By a member of the group in consultation with other health care practitioners, whether or not they are members of the group; and (b) Reviewing laboratory tests, as well as the services of other health care practitioners who do not directly treat patients. (5) “Personally supervised” means the responsibility of a health care practitioner to exercise on-site supervision or immediately available direction for employees performing referred in-office ancillary services or tests. (6) “Referring health care practitioner” means a health care practitioner, or group practice, who makes a referral. (7) “Rental or lease of office space” means payments made for the rental or lease of utilities, use of equipment, and secretarial and support staff. #### Regulation .03 Definitions—For Exemption from Self-Referral Laws. *COMAR 10.01.15.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Area of concentration” means a limitation of practice by demonstrable training and competence of a health care practitioner. (2) “Department” means the Maryland Department of Health. (3) “Essential” means a health care entity would not be able to exist but for the health care practitioner's beneficial interest in the health care entity. (4) “Health care entity” has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. (5) Health Care Practitioner. (a) “Health care practitioner has the meaning stated in Health Occupations Article, §1-301, Annotated Code of Maryland. (b) “Health care practitioner” does not include a mortician, an assisted living manager, or a nursing home administrator, unless the mortician, assisted living manager, or nursing home administrator is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services by any board other than the Board of Morticians and Funeral Directors or the Board of Long-Term Care Administrators. (6) “Maryland Health Care Commission (MHCC)” means the Maryland Health Care Commission. (7) “Referral” has the meaning stated in Health Occupation Article, §1-301, Annotated Code of Maryland. (8) “Requestor” means an individual other than the health care practitioner who is an attorney admitted to the Maryland Bar or specially admitted to practice law in the State under Maryland Rules Title 19. (9) “Secretary” means the Secretary of the Maryland Department of Health or their designee. (10) “Specialty” means “area of concentration” as defined in §B(1) of this regulation. #### Regulation .04 Scope of Exemption. *COMAR 10.01.15.04* The Secretary may exempt a health care practitioner from the prohibition on self-referral pursuant to Health Occupations Article, §1-302(d)(5), Annotated Code of Maryland, in accordance with this chapter. #### Regulation .05 Request for Exemption. *COMAR 10.01.15.05* A. A health care practitioner who has or wishes to have a beneficial interest in a health care entity may request from the Secretary an exemption from the self-referral laws. B. In order for a health care practitioner to obtain an exemption by the Secretary from the self-referral laws, the health care practitioner shall make a request to the Secretary in the manner specified by the Department that: (1) Identifies the street address, political subdivision, and area of concentration of both the health care practitioner and the entity in which the practitioner has or wishes to have a beneficial interest; (2) Demonstrates to the Secretary's satisfaction that the health care practitioner's beneficial interest is: (a) Essential to finance and to provide the health care entity; and (b) Needed to ensure appropriate access for the community to the services provided at the health care entity; (3) States when the services are proposed to begin; (4) Provides the health care practitioner’s: (a) Name; (b) Licensing board; (c) License number; (d) License expiration date; (e) Business address; and (f) Business telephone number; (5) Includes an attestation in writing that, if the health care practitioner seeks renewal of an exemption from the Secretary and the Secretary no longer deems the beneficial interest to be essential, the practitioner shall: (a) Immediately cease accepting any referrals from sources prohibited under Health Occupations Article, §1-301 et seq., Annotated Code of Maryland; or (b) Divest the practitioner's beneficial interest in the entity within 1 year after the exemption is no longer applicable. C. Request to MHCC. (1) The Secretary shall request, in writing, the advice of the Executive Director of the MHCC concerning whether the beneficial interest is needed to ensure appropriate access for the community to the services provided at the health care entity. (2) The Secretary shall provide, with the request to the Executive Director of the MHCC, a copy of any materials submitted to the Department in accordance with §B of this regulation and any additional items which may be pertinent to the MHCC’s review. (3) The Secretary shall follow the timetable set forth in Regulation .06 of this chapter. D. The Executive Director of the MHCC shall advise the Secretary in accordance with the timetable in Regulation .06 of this chapter as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity. E. If additional information is needed by the Secretary or the Executive Director of MHCC for their determination, the Department may ask the health care practitioner to provide additional information to establish that the practitioner’s beneficial interest is: (1) Essential to finance and to provide the health care entity; and (2) Needed to ensure appropriate access for the community to the services provided at the health care entity. #### Regulation .06 Timetable for the Secretary's Action. *COMAR 10.01.15.06* A. The Secretary shall make the required determinations within 90 calendar days following receipt of a health care practitioner's request for exemption. B. The Secretary shall request advice from the Executive Director of the MHCC as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity within 30 calendar days of receipt of the health care practitioner’s request for exemption. C. The Executive Director of the MHCC shall advise the Secretary as to whether the health care entity is needed to ensure appropriate access for the community to the services provided at the health care entity within 60 calendar days after receipt of the Secretary's letter. #### Regulation .07 Renewal of Exemption. *COMAR 10.01.15.07* A. The term of an exemption shall be in conjunction with a health care practitioner's professional license renewal and shall be renewed at the same time the health care practitioner's professional license is renewed. B. The exemption expires at the end of its term, unless the exemption is renewed in accordance with this regulation. C. An exempted health care practitioner, on renewal, shall meet all the requirements of this chapter at the time of renewal. D. Each health care practitioner who has been exempted by the Secretary from the prohibition on self-referral as an essential health care entity needed for access to health care shall renew the health care practitioner's exemption status in the manner provided by the Department at the time of licensure, certification, or other form of practice renewal authorized under the Health Occupations Article, Annotated Code of Maryland, within the time period specified on the form. E. At a minimum, the health care practitioner shall provide, at the time of renewal, to the Department: (1) A copy of the initial exemption request; (2) A copy of the Secretary’s approval of the initial exemption; (3) The items specified in Regulation .05B of this chapter; and (4) Any additional pertinent information as requested by the Secretary. F. Each exempted health care practitioner shall keep the appropriate licensing, certification, or other practice authorizing board apprised of the health care practitioner’s current business address. G. On request by the Department, the relevant board or boards shall supply the current business addresses of exempted health care practitioners. H. The Department shall mail a notice of the required renewal to the health care practitioner at the current business address supplied by the appropriate board. I. If an exempted health care practitioner does not receive notice of renewal, it is the exempted health care practitioner's responsibility to notify the Department so that the Secretary may renew the exemption before the expiration of the current exemption. J. Failure to Renew Exemption. (1) If an exempted health care practitioner fails to renew the exemption, the practitioner is not considered exempted under the Health Occupations Article, §1-301(d)(5), Annotated Code of Maryland. (2) If an exempted health care practitioner fails to renew the exemption, and fails to carry out the agreed requirements set forth in Regulation .05B(6) of this chapter, the practitioner shall be subject to disciplinary action as set forth in Health Occupations Article, §1-307, Annotated Code of Maryland, for violation of the self-referral laws. ### Chapter 16 — Retention and Disposal of Medical Records and Protected Health Information **Authority:** Health-General Article, §4-403, Annotated Code of Maryland; **Administrative History:** Effective date: March 24, 2008 (35:6 Md. R. 697) #### Regulation .01 Scope. *COMAR 10.01.16.01* A. This chapter applies to medical records and protected health information held by health care providers practicing in Maryland, their agents, and their records management service. B. This chapter does not supersede any federal or State laws or regulations that exceed this chapter's requirements by requiring that a medical record: (1) Be retained for a longer period of time; (2) Be afforded greater security measures; (3) Be afforded more privacy measures; and (4) Be more easily accessible to the patient. C. This chapter is not intended to address the disposition of abandoned medical records. #### Regulation .02 Definitions. *COMAR 10.01.16.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Divisible” means a medical record that is amenable to separation or division after the expiration of the retention time stated in Regulation .04 of this chapter. (2) Health Care Provider. (a) “Health care provider” means an acupuncturist, audiologist, chiropractor, dietician, dentist, electrologist, massage therapist, mortician, nurse, nutritionist, occupational therapist, optometrist, physical therapist, physician, podiatrist, professional counselor, psychologist, social worker, speech-language pathologist, or a health care facility or entity that is a: (i) Freestanding, ambulatory care facility as defined in Health-General Article, §19-3B-01, Annotated Code of Maryland; (ii) Freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland; (iii) Health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland; (iv) Hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland; (v) Limited service hospital as defined in Health-General Article, §19-301, Annotated Code of Maryland; (vi) Related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland; (vii) Residential treatment center as defined in Health-General Article, §19-301, Annotated Code of Maryland; and (viii) Health care facility as defined in Health-General Article, §10-101, Annotated Code of Maryland. (b) “Health care provider” includes an agent, officer, director, or employee of any entity listed in §B(2)(a) of this regulation. (3) Medical Record. (a) “Medical record” means any oral, written, or other transmission in any form or medium of information that: (i) Is entered in the record of a patient; (ii) Identifies or can readily be associated with the identity of a patient; and (iii) Relates to the health care of the patient. (b) “Medical record” includes any: (i) Documentation of disclosures of the medical record to any person who is not an employee, agent, or consultant of the health care provider; (ii) File or record maintained under Health Occupations Article, §12-403(b)(13), Annotated Code of Maryland, by a pharmacy of a prescription order for drugs, medicines, or devices that identifies or may be readily associated with the identity of a patient; (iii) Documentation of an examination of a patient regardless of who requested the examination or is making payment for the examination; (iv) File or record received from another health care provider that relates to the health care of a patient received from that health care provider, and identifies or can readily be associated with the identity of the patient; and (v) To the extent not narrowed by §B(3)(a) and (b)(i)—(iv) of this regulation, “protected health information” as defined by 45 CFR §160.103, as amended. (4) “Medical records series” means a set of medical records, as defined in §B(3) of this regulation, that is maintained on paper, microform, magnetic disk, magnetic tape, or other medium. (5) “Patient” has the meaning stated in Health-General Article, §4-301(j), Annotated Code of Maryland. (6) “Person in interest” has the meaning stated in Health-General Article, §4-301(k), Annotated Code of Maryland. (7) “Records management service” means any agent that has been procured by a health care provider to transport, handle, manage, maintain, store, or destroy medical records. (8) “Records retention schedule” means a records management plan that includes: (a) A list and description of the medical records series of an office or unit; (b) The minimum retention period required to keep each medical record series; (c) The eventual disposition instructions; (d) If desired: (i) Maintenance procedures, such as access or copy control, for each medical records series both in office and in storage; (ii) Scanning or microfilming instructions; or (iii) Disposal methods such as shredding or incineration; and (e) A signature of approval by an individual with authority over all the medical records series listed. (9) “Sanitizing” means overwriting, degaussing, shredding, or burning electronic or other media. #### Regulation .03 Incorporation by Reference. *COMAR 10.01.16.03* In this chapter, the following documents are incorporated by reference: A. 45 CFR Part 160, as amended; and B. 45 CFR Part 164, as amended. #### Regulation .04 Maintenance of Medical Records. *COMAR 10.01.16.04* A. A health care provider shall develop and maintain a records retention schedule compatible with the requirements of Regulations .04—.07 of this chapter. B. Except as provided in Regulations .06 and .07 of this chapter, a health care provider shall maintain medical records for all patients in the health care provider's care for a minimum of 5 years after the medical record is made or until the patient is 21 years old, whichever is longer. C. Medical records are the personal property of the entity providing health care and are maintained for: (1) The patient; (2) The medical or treatment staff; and (3) Other treatment, payment, and health care operations. D. A health care provider shall retain medical records in: (1) An office with access restricted to authorized staff; (2) A computer or other device with appropriate security such as passwords or data encryption; (3) A commercial records storage site with appropriate environmental and security controls; or (4) Other storage options that ensure protection, security, and access control. E. Maintenance of medical records may be contracted to a records management service that agrees to comply with and be subject to this chapter. F. Medical records that have been placed in storage remain the responsibility of the health care provider, including: (1) Providing the patient or person in interest access to their medical records and authorized copies upon request in accordance with Health-General Article, §4-304, Annotated Code of Maryland, and 45 CFR §164.524, as amended; (2) Ensuring the confidentiality of the medical records; (3) Providing security and restricted access to the medical records; and (4) Protecting the medical records from: (a) Damage; (b) Loss; and (c) Deterioration. G. If a medical record is kept in electronic form, a health care provider shall: (1) Maintain or have access to compatible electronic hardware and software that will enable the health care provider to generate a legible copy of the record in order to comply with patient and governmental access needs; and (2) Prepare and maintain a current back-up copy of electronic medical record files. #### Regulation .05 Disposal of Medical Records. *COMAR 10.01.16.05* A. A health care provider shall maintain a medical record in accordance with the records retention schedule and may dispose of the record when the minimum retention requirements as described in Regulation .04B of this chapter have been met. B. For purposes of destruction, a medical record is an indivisible entity unless, in the health care provider's professional judgment, the medical record is divisible. C. A health care provider shall ensure confidentiality of medical records throughout the disposal process: (1) For paper records, by incineration, shredding, pulping, or other comparable process which renders the records permanently unreadable; (2) For electronic or magnetic media, such as computer disks or magnetic tapes, by completely sanitizing the media, and not just by erasure or deletion; (3) For other media, such as film, photos, or compact discs, by destroying the media with no possibility of recovery; and (4) By complying with the HIPAA security provisions at 45 CFR §164.310(d), as amended. #### Regulation .06 Instructions for Handling Medical Records Upon Discontinuation of Medical Practice. *COMAR 10.01.16.06* A. At the time a health care provider discontinues medical practice, the health care provider shall immediately secure the medical records until one of the following options are taken: (1) Medical records may be transferred to a health care provider who will be assuming the medical practice; (2) Medical records may be given to the patient; (3) At the patient's direction, the medical record may be transferred to a new health care provider; or (4) Medical records may be destroyed in accordance with §B of this regulation, Regulation .07 of this chapter, or both. B. On the death, retirement, surrender of license, or discontinuance of the practice or business of a health care provider, the administrator of the estate or a designee, who: (1) Agrees to provide for the maintenance of the medical records of the practice; and (2) States in writing to the appropriate health occupations board within a reasonable time that the medical records will be maintained in compliance with this chapter, shall: (a) Publish a notice in a daily newspaper that is circulated locally for 2 consecutive weeks: (i) Stating that the medical records will be destroyed or transferred; and (ii) Designating a location, date, and time when the medical records may be retrieved by the person in interest; or (b) Forward the notice required in §B(2)(a), of this regulation, to the patient in the following manner: (i) In the case of an adult, the notification shall be sent by first-class mail to the last known address of the patient; or (ii) In the case of a minor, notification shall be sent by first-class mail to the last known address of the parent or guardian, or if the medical care documented was provided under Health-General Article, §20-102(c) or 20-103(c), Annotated Code of Maryland, notification shall be given to the minor, by certified mail, addressee only. #### Regulation .07 Prerequisites for Early Destruction of Medical Records. *COMAR 10.01.16.07* Medical records that have not met the retention requirements of Regulation .04 of this chapter, may be destroyed only if: A. In the case of an adult, notification is sent by first-class mail to the last known address of the patient which includes: (1) The proposed date of disposal; and (2) A statement that the record, or a synopsis of the record, may be retrieved at a designated location within 30 days of the proposed destruction; or B. In the case of a minor, notification is sent by first-class mail to the last known address of the parent or guardian, or if the medical care documented was provided under Health-General Article, §20-102(c) or 20-103(c), Annotated Code of Maryland, notification is given to the minor, by certified mail, addressee only, which includes: (1) The proposed date of disposal; and (2) A statement that the record, or a synopsis of the record, may be retrieved at a designated location within 30 days of the proposed destruction. #### Regulation .08 Enforcement. *COMAR 10.01.16.08* A. For entities and individuals not regulated by the Office of Health Care Quality or the appropriate health occupations board, the Secretary shall have the authority to investigate any complaint concerning medical records that are covered by this chapter. By letter, the Secretary may delegate this authority to any unit of the Department, including a health occupations board, the Office of Health Care Quality, or the Office of the Inspector General. B. To ensure compliance and enforce this chapter: (1) The Office of Health Care Quality shall have authority over a health care facility; and (2) A health occupations board shall have authority over an individual who is a health care provider. C. The Office of Health Care Quality, the appropriate health occupations board, or both, shall investigate any complaint concerning medical records that are or were in the possession of a person or entity covered by this chapter. D. After giving a person or entity an opportunity for a hearing to be held in accordance with the disciplinary hearing procedures that would be applicable to a health care provider who owned or possessed the medical records at issue, the Office of Health Care Quality, the appropriate health occupations board, or both, may impose any fines stated in Regulation .09B, of this chapter, as appropriate. E. After giving a person or entity an opportunity for a hearing to be held in accordance with COMAR 10.01.03, the Secretary may impose any fines stated in Regulation .09B of this chapter for entities which are not regulated by the Office of Health Care Quality or an appropriate health occupations board. #### Regulation .09 Penalties. *COMAR 10.01.16.09* A. Damages. As provided in Health-General Article, §4-403(g)(1), Annotated Code of Maryland, a health care provider, record management service, or other person who knowingly violates any provision of Health-General Article, Title 4, Subtitle 4, is liable in court for actual damages. B. Fines. (1) A health care facility that knowingly violates this chapter is subject to an administrative fine not to exceed $10,000 for all violations cited in a single day. (2) In addition to any other penalties provided, an individual who is a health care provider, an agent, employee, officer, or director of a health care provider, or a records management service, who knowingly violates this chapter, is subject to administrative fines as follows: (a) The first fine or set of fines assessed in a single day may not exceed $1,000; (b) The second fine or second set of fines assessed concurrently for all violations cited in a single day may not exceed $2,500; and (c) The third or subsequent fine assessed, or third or subsequent set of fines assessed concurrently, for all violations cited in a single day may not exceed $5,000. C. Factors to be Considered in the Assessment of Penalties. When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary, the Office of Health Care Quality, or the appropriate health occupations board shall consider the following factors: (1) The nature and seriousness of the violations; (2) The willfulness of the violation or violations; (3) The history of previous violations; (4) The extent of the actual harm or potential risk of divulging confidential information; (5) The efforts made to correct the violation or violations in a timely manner; and (6) The existence of mitigating factors. ### Chapter 17 — Fees for Food Protection, Public Pools, Public Spas, Public Spray Grounds, and Youth Camp Programs **Authority:** Health-General Article, §§2-104, 14-403, 14-403.1, 14-407(B)(4), 21-301, 21-308, 21-309, 21-309.1, 21-403, 21-412, 21-808, and21-812, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 and .02 adopted as an emergency provision effective November 1, 2004 (31:23 Md. R. 1649); adopted permanently effective February 14, 2005 (32:3 Md. R. 290) **Administrative History:** Regulation .01 amended effective April 13, 2015 (42:7 Md. R. 567) **Administrative History:** Regulation .02 amended effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .02 amended as an emergency provision effective January 3, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .02 amended effective April 13, 2015 (42:7 Md. R. 567); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .02B amended as an emergency provision effective April 5, 2011 (38:10 Md. R. 612) **Administrative History:** Regulation .02B amended effective June 27, 2011 (38:13 Md. R. 755) **Administrative History:** Regulation .02C amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 25, 2006 (33:19 Md. R. 1560) **Administrative History:** Regulation .02C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .02C amended effective September 17, 2012 (39:18 Md. R. 1196); December 21, 2015 (42:25 Md. R. 1542) **Administrative History:** Regulation .02E, F adopted effective September 17, 2012 (39:18 Md. R. 1196) **Administrative History:** Regulation .02H adopted as an emergency provision effective January 6, 2025 (52:2 Md. R. 65); amended permanently effective April 14, 2025 (52:7 Md. R. 321) #### Regulation .01 Scope. *COMAR 10.01.17.01* This chapter applies to entities regulated by the Office of Food Protection and the Office of Healthy Homes and Communities. #### Regulation .02 Fees. *COMAR 10.01.17.02* The following fees are established by the Secretary: A. Annual permit or inspection fee for: (1) Bobtailer — $50; (2) Bulk milk hauler/sampler — $50; (3) Certified industry dairy farm inspector — $10; (4) Distribution station — $25; (5) Farmstead cheese processor — $100; (6) Milk processor — $100; (7) Milk tank truck cleaning facility — $25; (8) Milk transportation company — $5, plus $5 for each milk tank truck; (9) Receiving station — $25; and (10) Transfer station — $25; B. Annual youth camp application fee based on estimated camper days, that is, the estimated average number of campers enrolled each day multiplied by the estimated number of days a camp intends to operate during a camp season, for: (1) Except as specified in §B(2) of this regulation: (a) On or before December 31, 2016, day camp: (i) 1 to 500 camper days — $200; (ii) 501 to 2,000 camper days — $525; (iii) 2,001 to 5,000 camper days — $700; and (iv) Greater than 5,000 camper days — $900; (b) Effective January 1, 2017, day camp: (i) 1 to 500 camper days — $190; (ii) 501 to 2,000 camper days — $500; (iii) 2,001 to 5,000 camper days — $665; and (iv) Greater than 5,000 camper days — $855; and (c) Residential camp: (i) 1 to 700 camper days — $500; (ii) 701 to 5,000 camper days — $1,000; (iii) 5,001 to 16,000 camper days — $1,500; and (iv) Greater than 16,000 camper days — $2,000; or (2) For a youth camp that is in good standing as defined in COMAR 10.16.06.02: (a) On or before December 31, 2016, day camp: (i) 1 to 500 camper days — $50; (ii) 501 to 2,000 camper days — $130; (iii) 2,001 to 5,000 camper days — $175; and (iv) Greater than 5,000 camper days — $225; (b) Effective January 1, 2017, day camp: (i) 1 to 500 camper days — $45; (ii) 501 to 2,000 camper days — $125; (iii) 2,001 to 5,000 camper days — $165; and (iv) Greater than 5,000 camper days — $215; and (c) Residential camp: (i) 1 to 700 camper days — $125; (ii) 701 to 5,000 camper days — $250; (iii) 5,001 to 16,000 camper days — $375; and (iv) Greater than 16,000 camper days — $500. C. Annual license fee for: (1) Food processing plants: (a) Bakery plant — $150; (b) Cannery — $150; (c) Charity deer processing plant, as defined in COMAR 10.15.04 — no fee; (d) Civic or nonprofit organizations that process meat for human consumption no more than three times a year for 5 days or less each time — $150; (e) Confectionary plant — $150; (f) Crab meat plant — $150; (g) Ice manufacturing plant — $150; (h) Shellfish: (i) Shucking, packing, or repacking plant — $150; (ii) Shipping or reshipping plant — $150; or (iii) Seasonal shellstock shipping or reshipping plant — $100; (i) Food manufacturing plant — $150; (j) A food warehouse or distribution center that distributes: (i) Potentially hazardous food — $150; or (ii) Only non-potentially hazardous food — $150; (k) Bottled water plant — $150; (l) Soft drink manufacturing plant — $150; (m) Frozen food manufacturing plant — $150; (n) Seasonal food manufacturing plant — $35; (o) On-farm home processing plant — $30; and (p) Producer mobile farmer’s market unit — $100; and (2) Frozen dessert mix or frozen dessert plant with manufacturing capacity of: (a) 0 to 25,000 gallons — $10; (b) 25,001 to 100,000 gallons — $50; (c) 100,001 to 250,000 gallons — $100; (d) 250,001 to 500,000 gallons — $150; and (e) Over 500,000 gallons — $200; D. Except for a local subdivision with delegated authority, plan review fee for food processing plants: (1) Bakery plant — $300; (2) Bottled water plant — $300; (3) Cannery — $300; (4) Charity deer processing plant — no fee; (5) Civic or nonprofit organizations that process meat for human consumption no more than three times a year for 5 days or less each time — $150; (6) Confectionary plant — $300; (7) Crab meat plant — $300; (8) Food manufacturing plant — $300; (9) Food manufacturing plant operating in another licensed food establishment — $200; (10) Food warehouse or distribution center — $300; (11) Frozen food manufacturing plant — $300; (12) Ice manufacturing plant — $300; (13) On-farm home processing plant — no fee; (14) Producer mobile farmer’s market unit — no fee; (15) Seasonal food manufacturing plant — no fee; and (16) Shellfish: (a) Shucking, packing, or repacking plant — $300; (b) Shipping or reshipping plant — no fee; or (c) Seasonal shellstock shipping or reshipping plant — no fee; E. Plan review fee for a food service facility that is a retail chain or a franchise operation planning to construct two or more facilities in the State from a single uniform set of plans — $300; F. Food process or hazard analysis critical control point plan review: (1) In a retail facility or a food processing plant — $200; or (2) In a bona fide civic or nonprofit organization that processes meat for human consumption no more than three times a year for 5 days or less each time — $150; and G. Except for a local subdivision with delegated authority, application review fee for: (1) Construction of a public pool or spa — $300; (2) Alterations at a public pool or spa — $200; and (3) Replacements at a public pool or spa — $50. H. Criminal History Record Checks. Fees for criminal history record checks for youth camp personnel in accordance with COMAR 10.16.06.21 shall be: (1) $20 per background criminal history record check processed for a camp; and (2) Paid by a youth camp licensee annually. ### Chapter 18 — Sexual Abuse Awareness and Prevention Training **Authority:** Health-General Article, §2-104, 7.5-205, 7-1002, and 10-705, Annotated Code of Maryland **Administrative History:** Effective date: November 23, 2015 (42:23 Md. R. 1433) **Administrative History:** Chapter revised effective December 27, 2021 (48:26 Md. R. 1110) #### Regulation .01 Scope. *COMAR 10.01.18.01* This chapter: A. Prohibits inappropriate sexual behavior in covered programs; and B. Adopts awareness and prevention training and reporting requirements regarding inappropriate sexual behavior that a covered program shall fulfill in order to be licensed by the Department or any of its Administrations, or approved by the Department or any of its Administrations to receive funding to provide services in Maryland. #### Regulation .02 Definitions. *COMAR 10.01.18.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Admission” means the process by which an individual is accepted as a resident or patient in a State facility and includes the physical act of the individual entering the State facility. (2) “Central coordinator” means an individual or individuals designated by the Deputy Secretary for the unit of the Department responsible for the operations of each State facility to: (a) Oversee development of policies and materials; (b) Monitor compliance; and (c) Identify and make recommendations for improving a State facility’s prevention and detection of, and response to, inappropriate sexual behavior in State facilities. (3) “Covered program” means any of the following facilities and programs: (a) A State facility as defined in §B(22) of this regulation; (b) Non-State operated residential treatment centers for emotionally disturbed children and adolescents, licensed under COMAR 10.07.04; (c) Vocational and day services programs, licensed by the Developmental Disabilities Administration under COMAR 10.22.02 and 10.22.07; and (d) The following programs licensed by the Behavioral Health Administration: (i) Psychiatric rehabilitation programs for adults licensed under COMAR 10.63.03.09; (ii) Residential rehabilitation programs licensed under COMAR 10.63.04.05; (iii) Supported employment programs licensed under COMAR 10.63.03.16; and (iv) Psychiatric rehabilitation programs for minors licensed under COMAR 10.63.03.10. (4) “Department” means the Maryland Department of Health. (5) External Law Enforcement Agency. (a) “External law enforcement agency” means the Department of State Police or a police agency of a county or municipal corporation. (b) “External law enforcement agency” does not include the police force of the Maryland Department of Health. (6) “Inappropriate sexual behavior” means: (a) Sexual abuse as defined in §B(17) of this regulation; and (b) Any sexual act, as defined in §B(18) of this regulation, between a staff member of a covered program and an individual receiving services at the covered program. (7) “Individual” means a person receiving services or treatment at a State facility. (8) “Initial plan of care” means the first plan of care created for an individual by the treatment team and is created at the first treatment team meeting. (9) “Internal complaint process” means a written policy and procedure for a covered program’s handling and investigation of reports of inappropriate sexual behavior, as defined in §B(3) of this regulation, and appropriate actions in response to verified incidents of inappropriate sexual behavior, occurring within the covered program. (10) “Licensed” means being licensed by the Department or approved by the Department to receive funding to provide services in Maryland. (11) “Peer training” means awareness and prevention training regarding inappropriate sexual behavior that is provided by a peer of the individual receiving services. (12) “Plan of care” means a written document addressing the needs of the individual receiving services from a covered program, and the covered program’s plan for provision of services and treatment to meet those needs, developed in accordance with applicable State and federal laws and regulations. (13) “Program director” means the individual who is responsible for the daily operations of a covered program as outlined in the chapter under the appropriate subtitle that delineates the requirements for a specific program. (14) “Protection plan” means a document created to address the individual’s needs, with respect to the individual’s: (a) Risk of being subjected to the perpetrator of inappropriate sexual behavior at the facility; and (b) Treatment team’s plan for mitigating the individual’s risk. (15) Reasonable Safety Precautions. (a) “Reasonable safety precautions” means an established set of measures, procedures, and protocols taken in order to maintain the safety of individuals upon admission to the State facility. (b) Reasonable safety precautions may include but are not limited to: (i) Unit restriction, including dining on the unit; (ii) Increased nursing contacts or more frequent observation by nurses; (iii) Restrictions on activities; (iv) Increased staffing assigned to the individual; and (v) Similar or additional measures implemented. (c) The type of reasonable safety precautions implemented and the reason for the reasonable safety precautions shall be documented in the individual’s records. (16) “Risk assessment screen” means a uniform tool, developed by the Department, used by a facility to: (a) Screen an individual for a history of being subjected to, or perpetrating, inappropriate sexual behavior, and related trauma; and (b) Assess an individual’s risk of being subjected to, or perpetrating, inappropriate sexual behavior while at the facility. (17) Sexual Abuse. (a) “Sexual abuse” means any sexual act, as defined in §B(18) of this regulation, that is made or threatened to be made without the consent of an individual who is the recipient of the action, or without the consent of an individual solicited to take the action, which occurs on the premises of a covered program or at any off-premises activity sponsored by the covered program. (b) “Sexual abuse” includes sexual harassment and sexual assault. (c) “Sexual abuse” does not include an action taken reasonably related to the provision of care, treatment, or services to an individual including: (i) The performance of an accepted medical or behavioral procedure pursuant to and in accordance with orders of an appropriately qualified licensed health care professional; and (ii) An action taken by a staff member that complies with applicable laws and policies on the use of physical intervention. (18) “Sexual act” means any of the following, if it can reasonably be construed to be for sexual arousal or gratification, or for the abuse of either party, and not for an accepted medical or behavioral purpose: (a) An act in which an object or part of an individual’s body penetrates, however slightly, into another individual’s genital opening or anus; (b) Intentional physical contact, or an attempt to make physical contact, either directly or through clothing, between the genitals, finger or fingers, hand or hands, or mouth of one individual and the genitals, groin, inner thigh, buttocks, anus, breast, or mouth of another individual; (c) Intentional physical contact, or an attempt to make physical contact, between the tongue or mouth of one individual and any part of the body of another individual; (d) The following nonphysical contacts: (i) The intentional exposure by an individual to another of the individual’s naked genitals, groin, inner thigh, buttocks, anus, or breast; (ii) The intentional exposure by an individual to another of photographs of an individual’s naked genitals, groin, inner thigh, buttocks, anus, or breast; (iii) The intentional observation by an individual of another individual’s naked genitals, groin, inner thigh, buttocks, anus, or breast; (iv) Verbal or written description of, questions or suggestions regarding, or requests for any of the physical contacts described in §B(18)(a)—(c) of this regulation; (v) Photographing, drawing, transmitting an image of, saving an image of, or recording the naked body or body parts of another individual; (vi) Intentionally exposing an individual to photographs, pictures, drawings, diagrams, or other graphic depictions of naked body or body parts of an individual; and (vii) Intentionally causing another individual to make or attempt any of the physical contacts described in §B(18)(a)—(c) of this regulation; and (e) Other intentional acts directed to another individual and performed for the purpose of arousing sexual thoughts or feelings and not for purposes related to the provision of care. (19) “Sexual assault” means any of the following: (a) A sexual offense as defined in Criminal Law Article, Title 3, Annotated Code of Maryland; and (b) Any other sexual act that is a crime under State or federal law. (20) “Sexual harassment” means intimidation, bullying, or coercion of a sexual nature or unwelcome sexual advances, requests for sexual favors, and other verbal or physical conduct of a sexual nature that tends to create a hostile or offensive environment. (21) “Staff member” means any individual employed by a covered program, whether contractually or permanently, and any individual who volunteers with, is a contractor for or consultant to, works as an intern or resident for, or otherwise is engaged by, the covered program at any facility or location in which services are provided to individuals. (22) “State facility” means the following institutions operated by the Department: (a) A psychiatric hospital, licensed pursuant to COMAR 10.07.01; (b) An intermediate care facility for individuals with developmental disabilities licensed pursuant to COMAR 10.07.20; (c) A forensic residential center, licensed pursuant to COMAR 10.07.13; and (d) Regional institutes for children and adolescents licensed and operated pursuant to COMAR 10.07.04 and COMAR 10.21.06. (23) “Treatment team” means the group of individuals at the covered program who, in accordance with applicable State and federal law and regulations, are responsible for the development and implementation of a plan of care for an individual receiving services from the covered program. #### Regulation .03 Covered Program Policies. *COMAR 10.01.18.03* A. This regulation applies to the following covered programs as defined in Regulation .02 of this chapter: (1) State facilities; (2) Vocational and day service programs; (3) Psychiatric rehabilitation programs for adults and minors; (4) Residential rehabilitation programs; and (5) Supported employment programs. B. A covered program shall ensure that the covered program adopts and enforces policies that: (1) Prohibit inappropriate sexual behavior that occurs while an individual is receiving services from a covered program: (a) Between a staff member and an individual served by the covered program; and (b) On the premises of the covered program or at any off-premises activity sponsored by the covered program, between: (i) Individuals served by the covered program; or (ii) An individual served by the covered program and another individual or individuals; (2) Require reporting of inappropriate sexual behavior in accordance with the requirements of Regulations .05 and .06 of this chapter; and (3) Provide for training of staff members and individuals receiving services in accordance with Regulation .04 of this chapter. #### Regulation .04 Training Requirements. *COMAR 10.01.18.04* A. This regulation applies to the following covered programs as defined in Regulation .02 of this chapter: (1) State facilities; (2) Vocational and day service programs; (3) Psychiatric rehabilitation programs for adults and minors; (4) Residential rehabilitation programs; and (5) Supported employment programs. B. A covered program shall include awareness and prevention training on inappropriate sexual behavior as part of the established orientation process for: (1) Staff members; and (2) Individuals receiving services from the covered program. C. The inappropriate sexual behavior awareness and prevention training module: (1) May be provided by the covered program or its contractor; and (2) Shall be pre-approved by the Developmental Disabilities Administration or Behavioral Health Administration, as applicable. D. Staff member training conducted in accordance with this regulation shall: (1) Include, but not be limited to: (a) An overview of inappropriate sexual behavior, including: (i) Types and definitions of inappropriate sexual behavior; and (ii) Trauma of inappropriate sexual behavior and its long-range effects; (b) Types and characteristics of inappropriate sexual behavior, including signs and symptoms of inappropriate sexual behavior; (c) Risk screening, protection plans, and prevention and detection measures for State facilities in accordance with Regulation .07 of this chapter; (d) Mandated reporting procedures, including the requirements of Regulations .05 and .06 of this chapter, regarding inappropriate sexual behavior; and (e) Confidentiality of information as it applies to inappropriate sexual behavior; (2) Be completed during new employee orientation; (3) Be updated on an annual basis; and (4) Be documented in the staff members’ personnel training files. E. Training for Individuals. (1) Training conducted in accordance with this regulation for individuals receiving services shall: (a) Be offered in language and terms, and using methods, appropriate to the ability of the individual being served to understand; (b) Include an element of peer training, unless disapproved by an individual’s treatment team for reasons that are documented in the individual’s records; (c) Be tailored to the individual’s abilities; (d) Be provided to an individual served by a covered program in two stages, as follows: (i) Key facts regarding identifying inappropriate sexual behavior and how to report it shall be provided within 5 days after initiation of services to the individual; and (ii) Comprehensive training as set out in this regulation shall be provided to the individual as soon as practical but no later than 6 months after initiation of services to the individual; (e) Be updated on an annual basis; and (f) Be documented in the individual’s plan of care. (2) Training conducted in accordance with this regulation for individuals receiving services shall include, but not be limited to: (a) The individuals’ rights and responsibilities with regard to inappropriate sexual behavior, including the right to be free from retaliation and further harm for reporting inappropriate sexual behavior; (b) Identifying and reporting inappropriate sexual behavior; (c) Crisis intervention, as appropriate; and (d) Referral resources and methods. #### Regulation .05 Mandatory Reporting Requirements. *COMAR 10.01.18.05* A. This regulation applies to the following covered programs as defined in Regulation .02 of this chapter: (1) Non-State operated residential treatment centers for emotionally disturbed children and adolescents; (2) Vocational and day service programs; (3) Psychiatric rehabilitation programs for adults and minors; (4) Residential rehabilitation programs; and (5) Supported employment programs. B. A covered program shall comply with the reporting requirements of: (1) COMAR 07.02.16.04; (2) COMAR 07.02.07.04; (3) This regulation; and (4) Any other applicable law or regulation requiring the reporting of inappropriate sexual behavior. C. Any staff member who observes, receives a complaint regarding, or otherwise has reason to believe that an individual has been subjected to inappropriate sexual behavior shall file a report with the program director promptly, but in no circumstances more than 1 working day, after becoming aware of the situation. D. Upon the receipt of a report made under §C of this regulation, the program director shall: (1) Immediately ensure: (a) The safety, security, privacy, and emotional support of the individual or individuals involved; and (b) That any medically appropriate and necessary care is provided to the individual or individuals involved; (2) Report the incident within 1 working day after receiving the report to: (a) The Behavioral Health Administration or the Developmental Disabilities Administration, or both, as applicable; (b) The Office of Health Care Quality; and (c) The State’s designated protection and advocacy agency. (3) Report the incident immediately, and in no circumstances more than 1 working day, after receiving the report to the appropriate law enforcement authorities if the reported inappropriate sexual behavior violates or may violate the law. E. The report made under §B(2) of this regulation shall be made using the form required by the Department. F. Promptly after completing an investigation of a report of inappropriate sexual behavior, the program director shall report the results of the investigation to: (1) The Behavioral Health Administration or the Developmental Disabilities Administration in accordance with applicable reporting procedures required by the Department; (2) The Office of Health Care Quality; (3) The State’s designated protection advocacy agency; and (4) The appropriate law enforcement authorities if the results of the covered program’s investigation indicate a violation of the law may have occurred, but the allegations were not initially reported pursuant to §D(3) of this regulation because the allegations, as initially reported, did not involve inappropriate sexual behavior that may violate the law. #### Regulation .06 Reporting Requirements for State Facilities. *COMAR 10.01.18.06* A. This regulation applies to State facilities. B. For purposes of this regulation, “discovery” means staff observes, receives a complaint from an individual or other source, or otherwise has reason to believe that inappropriate sexual behavior has occurred. C. A State facility shall comply with the reporting requirements of: (1) COMAR 07.02.16.04; (2) COMAR 07.02.07.04; (3) This chapter; and (4) Any other applicable law or regulation requiring the reporting of inappropriate sexual behavior. D. Policies and Training. (1) The facility shall adopt and enforce written policies and procedures for the reporting and investigation of inappropriate sexual behavior in accordance with the requirements set forth in this regulation and Regulation .03 of this chapter. (2) The facility shall provide training to staff members, upon hire and annually thereafter, regarding facility policies and procedures governing the prevention, reporting, and investigation of allegations of inappropriate sexual behavior in accordance with this regulation and Regulation .04 of this chapter, including: (a) Understanding the provisions of the memorandum of understanding; (b) Transporting individuals for medical care or to a SAFE exam, including how to support the individual during transportation and actions that may be taken to avoid the use of restraint; (c) Preservation of evidence; and (d) Counseling alleged victims, including regarding emergency contraception, prophylaxes for HIV or other sexually transmitted infections, and follow-up medical care or appointments. E. Reporting and Investigation of Inappropriate Sexual Behavior. (1) Facility staff members shall notify the administrative head of the facility, or the designee, of an allegation of inappropriate sexual behavior, immediately, but no later than 24 hours, from staff’s discovery of the allegation. (2) The notification required in §E(1) of this regulation shall be made on the form or in the manner designated by the Department. (3) Upon receipt of the notification in §E(1) of this regulation, the administrative head of the facility, or their designee, shall, within 24 hours of staff’s discovery of the allegation, provide written notice of the allegation to the: (a) Office of Health Care Quality; (b) Central coordinator; (c) State-designated protection and advocacy agency; (d) Treatment teams of the individuals involved in the allegation; and (e) Appropriate law enforcement agency as set forth in §F of this regulation. (4) If the administrative head of the facility or the central coordinator has a conflict of interest in receiving the notification, facility staff members shall report the incident to another individual designated by the facility in the event of such conflict of interest. F. Notification to Law Enforcement. (1) The facility shall notify the appropriate external law enforcement agency, within 24 hours of discovery by the facility, of: (a) An allegation of sexual assault occurring on the facility premises or at any off-premises activity sponsored by the facility between individuals served by the facility or an individual served by the facility and another individual; or (b) An allegation of inappropriate sexual behavior between a staff member and an individual served by the State facility, regardless of the location of the incident. (2) Except as provided in §F(1)(b) of this regulation, allegations of inappropriate sexual behavior that are not criminal shall be reported to the Department’s police force for further investigation. (3) The Department’s police force shall refer the allegations to the administrative head of the facility for further investigation as appropriate. (4) An individual shall be permitted to report an allegation of inappropriate sexual behavior that is not criminal to an external law enforcement agency or complete a statement of charges with the District Court commissioner. (5) The Department police force may not investigate a report of inappropriate sexual behavior made to an external law enforcement agency in accordance with §F(1) of this regulation unless the external law enforcement agency declines to investigate the report or requests the assistance of the Department police force. (6) Upon the receipt of the notification made under §E of this regulation, the treatment team or teams of the alleged victim and alleged perpetrator, if applicable, shall: (a) Review and, if appropriate, update the risk assessment screens and protection plans of the individuals involved in the allegation in accordance with Regulation .07G of this chapter; (b) Review and, if appropriate, revise the plans of care of the individuals involved in the allegation in accordance with Regulation .07G of this chapter; (c) Notify the central coordinator of the results of the treatment team’s review and assessment under this subsection; (d) Take other appropriate action to ensure: (i) The safety, privacy, and emotional support of the individual or individuals involved; and (ii) That any medically appropriate and necessary care is provided to the individual or individuals involved; and (e) Document the reported allegations and the results of any investigation of the allegations in the record of the individuals involved. (7) The facility and Department police shall investigate allegations of inappropriate sexual behavior in accordance with the following requirements: (a) A facility staff member or Department police officer may not participate in, or conduct, an investigation of an allegation of inappropriate sexual behavior if that staff member or officer, or the staff member’s immediate family member, was involved in the incident or incidents underlying the allegation; and (b) The facility shall comply with applicable laws and regulations governing the confidentiality of an individual’s information. (8) Promptly after completing an investigation of a report of inappropriate sexual behavior, the facility shall report the results of the facility’s investigation to the: (a) Appropriate unit of the Department as required by applicable statutes or regulations; (b) Office of Health Care Quality; and (c) State’s designated protection and advocacy agency. G. Regional Institutes for Children and Adolescents. (1) Allegations of inappropriate sexual behavior on the premises of a regional institute for children and adolescents that are not criminal shall be referred to the administrative head of the regional institute for children and adolescents for further investigation. (2) Allegations of sexual assault and inappropriate sexual behavior between an individual and a staff member shall be reported under §F(1) of this regulation. (3) The regional institute for children and adolescents shall report allegations of inappropriate sexual behavior to Child Protective Services pursuant to COMAR 07.02.07. H. Annual Report. (1) The central coordinator shall report annually to the Deputy Secretary for the unit within the Department which oversees the operations of each State facility on the following: (a) Development of polices and materials to implement the requirements of this regulation and Regulation .07 of this chapter; (b) Suggested revisions to the uniform assessment and reporting forms required in this regulation and Regulation .07 of this chapter; (c) Compliance with the assessment and reporting requirements of this regulation and Regulation .07 of this chapter; (d) Compliance with the training requirements of this regulation and Regulation .07 of this chapter; (e) Identification of barriers to compliance with the requirements of this regulation and Regulation .07 of this chapter; and (f) Recommendations to improve prevention, detection, and response by State facilities to inappropriate sexual behavior. (2) A copy of the report shall be provided to the State designated protection and advocacy agency. #### Regulation .07 Additional Requirements for State Facilities. *COMAR 10.01.18.07* A. This regulation applies to State facilities. B. Screening and Prevention Policies. (1) The facility shall adopt and enforce written policies and procedures for ensuring the facility screens for, and takes reasonable steps to mitigate, an individual’s risk of being subjected to, or the perpetrator of, inappropriate sexual behavior in accordance with the requirements set forth in this chapter. (2) The facility shall provide training to staff members, upon hire and annually thereafter, regarding: (a) The policies and procedures governing the risk screening and protection plans; and (b) Detection and prevention of inappropriate sexual behavior in accordance with this chapter. (3) The Department shall utilize a uniform risk assessment screening tool. C. Required Processes Upon Admission to Facility. (1) As soon as practicable, but no later than 3 business days after the individual’s admission, the facility shall make reasonable efforts to collect the individual’s medical and treatment records in accordance with §H of this regulation. (2) The facility shall implement reasonable safety precautions upon the individual’s admission. (3) Within 48 hours of the individual’s admission, clinical staff shall: (a) Complete a risk assessment screen of the resident, in accordance with §D of this regulation; (b) Complete a suicide risk assessment; and (c) If necessary, modify the reasonable safety precautions to mitigate the risks identified in the risk assessment screen. (4) Within 5 days after the individual’s admission, the treatment team shall meet to: (a) Review and, if appropriate, update the risk assessment screen; (b) Determine if a protection plan is necessary, based upon review of the risk assessment screen and, if so, develop a protection plan, in accordance with §E of this regulation; and (c) Develop the initial plan of care in accordance with §F of this regulation. D. Risk Assessment Screen. (1) To complete the risk assessment screen, clinical staff shall: (a) Use the form required by the Department; (b) Interview the individual; and (c) Document the individual’s responses regarding: (i) The individual’s history of trauma and other issues relevant to the individual’s risk of being subjected to, or the perpetrator of, inappropriate sexual behavior in the facility; (ii) Whether the individual feels safe in the facility, including why or why not; and (iii) What the individual believes would make them feel safe in the facility. (2) If the individual cannot be interviewed, the clinical staff shall document the reason on the risk assessment screen form. E. Protection Plan. (1) The treatment team shall develop a protection plan if the treatment team determines that it is necessary to mitigate the risk identified in the risk assessment screen. (2) The protection plan shall be completed on the form required by the Department. (3) If a protection plan is determined to not be necessary to mitigate the risk identified in the risk assessment screen, the rationale shall be documented in the risk assessment screen. (4) If an individual in a State facility has a behavior plan that includes the elements required in a protection plan, the behavior plan shall satisfy the requirements of this regulation and shall be labeled as a behavior and protection plan. F. Plan of Care. (1) When developing the initial plan of care, the treatment team shall: (a) Review and, if appropriate, update the risk assessment screen based upon the information available to the treatment team; and (b) Include a protection plan, if appropriate, pursuant to §E of this regulation. (2) The initial and all subsequent plans of care shall: (a) Incorporate the risk assessment screen and, if applicable, the protection plan; (b) Include consideration of the effect of trauma on the individual; and (c) Be authorized by a physician, psychiatrist, or other appropriately qualified person under applicable legal and operational standards. (3) The plan of care shall be reviewed at least every 3 months and whenever an individual’s risk assessment screen is updated. G. Review and Update of Risk Assessment Screens and Protection Plans. (1) The treatment team shall review the risk assessment screen, and update if necessary, every 3 months as part of the plan of care review. (2) The risk assessment may be reviewed more frequently if warranted by any new allegation of inappropriate sexual behavior or if additional information regarding risk factors is received by the treatment team. (3) The plan of care shall be reviewed when the risk assessment is updated. (4) The protection plan shall be reviewed and updated as needed or whenever the risk assessment is updated and when the plan of care is reviewed. (5) When reviewing the protection plan, the treatment team shall consider: (a) Effectiveness of strategies to reduce risk; (b) Whether new or modified strategies are warranted; and (c) The individual’s desires regarding the protection plan. H. Medical and Other Records. (1) The facility shall designate the staff member or members responsible for collecting the individual’s medical records in accordance with this subsection. (2) The facility shall make reasonable and documented efforts to collect medical records from the individual’s prior and current health care providers in accordance with this subsection, including: (a) Discharge summaries from all hospitals where the individual received treatment in the 3 years before the individual’s admission to the facility; and (b) Somatic and other health assessments performed in the 3 years before the individual’s admission to the facility. (3) The facility shall make reasonable and documented efforts to collect any other significant records identified by the facility that the treatment team determines are clinically necessary to develop and implement the individual’s plan of care. (4) Facilities shall make reasonable and documented efforts to collect information from the following sources related to the individual’s risk for being a victim or perpetrator of inappropriate sexual behavior, provision of trauma-related care or treatment, or the individual’s reduced decision-making capacity, as authorized by law: (a) Other State facilities; (b) Local jails or detention centers and facilities operated by the Department of Public Safety and Correctional Services; (c) The Department of Juvenile Services; (d) Local Departments of Social Services, to identify other sources; (e) Private hospitals and clinics; and (f) Any persons known to the Department to have knowledge to identify other sources, including sources indicated on the responses to the risk assessment screen. (5) Facilities shall access records in electronic databases whenever possible and as such data bases become available. (6) The facility shall comply with applicable laws and regulations governing the confidentiality and release of medical and other personal information pursuant to applicable State and federal laws and regulations. #### Regulation .08 Internal Complaint Process. *COMAR 10.01.18.08* A. This regulation applies to the following covered programs as defined in Regulation .02 of this chapter: (1) Vocational and day service programs; (2) Psychiatric rehabilitation programs for adults and minors; (3) Residential rehabilitation programs; and (4) Supported employment programs; B. A covered program shall: (1) Adopt and maintain an internal complaint process as defined in Regulation .02 of this chapter; (2) Provide a copy of the covered program’s written internal complaint process to each individual receiving services from the covered program: (a) During the individual’s orientation; and (b) At any time upon an individual’s request; (3) Prominently display, in accessible, centralized locations, the covered program’s internal complaint process; (4) Develop and maintain a form to use to make a complaint of inappropriate sexual behavior; and (5) Have available a staff member who is not involved in the alleged inappropriate sexual behavior to assist the individual in completing the complaint form. C. State facilities shall comply with the procedures set forth in COMAR 10.21.14. D. The internal complaint process shall: (1) Provide procedures for making a complaint of inappropriate sexual behavior; (2) Permit an individual alleging that the individual was subjected to inappropriate sexual behavior to use the covered program’s grievance process to address the alleged incident; (3) Include procedures for investigating a complaint of inappropriate sexual behavior; (4) Require that the covered program’s investigation of a complaint of inappropriate sexual behavior be completed within 7 calendar days after the investigation is initiated; (5) Allow participation by: (a) Representatives of, and as designated by, the individual who allegedly was subjected to the inappropriate sexual behavior; and (b) Any individual who is alleged to have committed the inappropriate sexual behavior; (6) Allow information to be presented to support the position of: (a) The individual who allegedly was subjected to the inappropriate sexual behavior; and (b) Any individual who is alleged to have committed the inappropriate sexual behavior; (7) Ensure the participation of the covered program staff members who have the authority to implement corrective action; (8) Require that the substance of the complaint and any actions taken in response to the complaint be documented; and (9) Require written notification of the covered program’s determination to: (a) The individual who allegedly was subjected to the inappropriate sexual behavior: (b) Any individual who is alleged to have committed the inappropriate sexual behavior; and (c) Appropriate covered program staff members or other individuals as necessary to take disciplinary or corrective action, or both. E. Any staff member determined to have engaged in inappropriate sexual behavior shall be permitted to make use of the covered program’s internal grievance process in any disciplinary action based upon the determination. #### Regulation .09 Confidentiality. *COMAR 10.01.18.09* State and federal confidentiality laws and regulations shall govern the redisclosure of information disclosed in all actions taken upon a report or complaint of inappropriate sexual behavior. #### Regulation .10 Effective Date. *COMAR 10.01.18.10* This chapter is effective January 1, 2015. ### Chapter 19 — *Vacant* ### Chapter 20 — Nursing Facility Quality Assessment **Authority:** Health-General Article, §19-310.1, Annotated Code of Maryland **Administrative History:** Effective date: October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .03E amended effective December 27, 2010 (37:26 Md. R. 1786); November 28, 2011 (38:24 Md. R. 1501); February 18, 2013 (40:3 Md. R. 217) #### Regulation .01 Scope. *COMAR 10.01.20.01* A. This chapter applies to the collection by the Maryland Department of Health of a quality assessment, pursuant to Health-General Article, §19-310.1, Annotated Code of Maryland, to be paid on a quarterly basis by nursing facilities subject to the assessment. B. All amounts collected under this chapter shall be distributed to a special fund to be used by the Department only to fund reimbursements to nursing facilities under the Medicaid program. #### Regulation .02 Definitions. *COMAR 10.01.20.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Assessment” means the quality assessment paid on a quarterly basis by each nursing facility subject to this chapter, determined by the Department for each facility based upon an amount per non-Medicare day of service for the previous quarter of the State fiscal year. (2) “Department” means the Maryland Department of Health. (3) “Medicaid” means the Medical Assistance Program in the Maryland Department of Health. (4) Nursing Facility. (a) “Nursing facility”, for purposes of this chapter, means a nursing facility, as defined in Health-General Article, §19-301, Annotated Code of Maryland, that has 45 or more beds, and operates in the State. (b) “Nursing facility” does not include a continuing care retirement community that has obtained a certificate of registration to provide continuing care under Human Services Article, Title 10, Subtitle 4, Annotated Code of Maryland. #### Regulation .03 Collection of Nursing Facility Quality Assessment. *COMAR 10.01.20.03* A. On or before the 60th day after each quarter of the State fiscal year, each nursing facility subject to the quality assessment shall pay the specified amount into a bank account established under the authority of the State Treasurer. B. Late Charge. (1) Payments not postmarked on or before the 60th day after each quarter are subject to an interest amount equal to the State of Maryland General Fund investment portfolio interest rate in effect at the time the payment is due. (2) The late charge is a one-time imposition for each quarterly delinquent payment and shall equal the applicable interest rate multiplied by the quality assessment amount that is unpaid on the payment due date. C. The amount of each facility's quarterly quality assessment shall equal the product of: (1) The per diem assessment amount, as annually calculated by and provided to the facility by the Department; and (2) The number of non-Medicare days of care provided by the facility during the previous quarter of the State fiscal year. D. With each quarterly quality assessment payment, each nursing facility paying the quality assessment shall report, on a form provided by the Department, the nursing facility's total number of patient days and non-Medicare patient days for that quarter. E. Effective July 1, 2012, the aggregated annual assessment collected under this chapter may not exceed 6 percent of the operating revenue for all nursing facilities subject to this assessment. F. The Department shall pursue collection and referral of unpaid quality assessments in accordance with the timetables and agency collection standards set forth in COMAR 17.01.01.04. ### Chapter 21 — Medical Orders for Life-Sustaining Treatment (MOLST) Form — Procedures and Requirements **Authority:** Health-General Article, §§2-104, 5-608, 5-608.1, and 5-609, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 2013 (39:25 Md. R. 1612) **Administrative History:** Regulation .02B amended effective February 17, 2014 (41:3 Md. R. 201) **Administrative History:** Regulation .03 amended effective February 17, 2014 (41:3 Md. R. 201) **Administrative History:** Regulation .04E amended effective February 17, 2014 (41:3 Md. R. 201) #### Regulation .01 Scope. *COMAR 10.01.21.01* This chapter sets out the Medical Orders for Life-Sustaining Treatment (MOLST) form, instructions, and certain related procedures and requirements developed by the Maryland Department of Health, in conjunction with the Board of Physicians and the Maryland Institute for Emergency Medical Services Systems. #### Regulation .02 Definitions. *COMAR 10.01.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advance directive” has the meaning stated in Health-General Article, §5-601(b), Annotated Code of Maryland. (2) “Assisted living program” has the meaning stated in COMAR 10.07.14.02. (3) “Authorized decision maker” means the health care agent, guardian of the person, or surrogate decision maker who is making health care decisions on behalf of a patient in accordance with the Health Care Decisions Act, Health-General Article, §§5-601—5-618, Annotated Code of Maryland. (4) “EMS DNR order” means an emergency medical services do not resuscitate order as defined in Health-General Article, §5-601(i), Annotated Code of Maryland. (5) “Guardian of the person” means a person appointed by a court to be a guardian of the person of a disabled individual in accordance with Estates and Trusts Article, §13-705, Annotated Code of Maryland. (6) “Health care” has the meaning stated in Health-General Article, §4-301(f), Annotated Code of Maryland. (7) “Health care agent” means an agent as defined in Health-General Article, §5-601(c), Annotated Code of Maryland. (8) “Health Care Decisions Act” means Health-General Article, §§5-601—5-618, Annotated Code of Maryland. (9) “Health care facility” has the meaning stated in Health-General Article, §5-608.1(a), Annotated Code of Maryland. (10) “Health care provider” has the meaning stated in Health-General Article, §5-601(l), Annotated Code of Maryland. (11) “Home health agency” has the meaning stated in COMAR 10.07.10.02. (12) “Hospice” means a hospice care program as defined in COMAR 10.07.21.02. (13) “Hospital” has the meaning stated in Health-General Article, §19-301(f), Annotated Code of Maryland. (14) “Kidney dialysis center” has the meaning stated in COMAR 10.05.04.01 (15) “Medical Orders for Life-Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland. (16) “Medical record” has the meaning stated in Health-General Article, §4-301(i), Annotated Code of Maryland. (17) “Minor” means an individual younger than 18 years old who is not married, not the parent of a child, and not otherwise authorized by law to consent to medical treatment. (18) “Nurse practitioner” has the meaning stated in Health-General Article, §5-601(p), Annotated Code of Maryland. (19) “Nursing home” means a comprehensive care facility or extended care facility as defined in COMAR 10.07.02.01. (20) Patient. (a) Except as provided in §(20)(b), “patient” has the meaning stated in Health-General Article, §4-301(k), Annotated Code of Maryland. (b) “Patient” does not include someone: (i) Whose primary diagnosis for the current treatment is a psychiatric disorder, except for dementia, delirium, or mental disorders due to a medical condition; (ii) Whose primary diagnosis is related to a current pregnancy; or (iii) Who is younger than 18 years old and who is unlikely to require a life-sustaining treatment. (21) “Physician” has the meaning stated in Health-General Article, §5-601(r), Annotated Code of Maryland. (22) “Physician assistant” has the meaning stated in Health-General Article, §5-601(s), Annotated Code of Maryland (23) “Practitioner” means a physician, nurse practitioner, or physician assistant. (24) “Substantial change in health status” means a change in a patient’s health or functional status that: (a) Demonstrates an improvement or decline in the patient’s status that requires the need for interdisciplinary review or revision of the patient’s health care; and (b) Is not a temporary change that is self-limited. (25) “Surrogate” means an individual who makes health care decisions for a patient pursuant to Health-General Article, §5-605, Annotated Code of Maryland. #### Regulation .03 Nature and Contents of the MOLST Form and Instructions. *COMAR 10.01.21.03* The content of the form and the form’s instructions are as follows: FORM AT END OF CHAPTER. #### Regulation .04 Use of the MOLST Form. *COMAR 10.01.21.04* A. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Defined Terms. (a) “Completing a MOLST form” means: (i) Certifying, when applicable, the bases for the orders contained therein; (ii) Completing section one for all patients and only those sections two through nine of the form that are related to the patient’s current medical condition and wishes for care; and (iii) Signing and dating the MOLST form. (b) “Updating a MOLST form” means to revise an existing MOLST form by voiding the existing form and completing a new MOLST form in accordance with the form’s instructions. B. Beginning July 1, 2013, the following health care facilities are required to accept, update if appropriate, and complete the MOLST form for each patient during the admission process in accordance with the form’s instructions: (1) An assisted living program; (2) A home health agency; (3) A hospice; (4) A kidney dialysis center; and (5) A nursing home. C. An assisted living program or a nursing home shall also complete the MOLST form for a patient: (1) Admitted before January 1, 2013; and (2) Who continues to reside in the assisted living program or nursing home after July 1, 2013. D. Beginning July 1, 2013, a hospital shall: (1) Accept and update if appropriate, a completed MOLST form in accordance with the form’s instructions; or (2) Complete a MOLST form for a patient during the patient’s inpatient stay if the patient is to be discharged or transferred to another health care facility. E. When initially completing a MOLST form or updating an existing MOLST form, a health care facility shall: (1) Offer the patient or authorized decision maker the opportunity to participate in completing or updating the MOLST form, and on request of the patient, offer any physician, nurse practitioner , or physician assistant selected by the patient the opportunity to participate in updating or completing the MOLST form; (2) Note in the medical record when a patient or an authorized decision maker declines to participate in completing or updating the MOLST form, indicating the date and time of discussion, with whom the form was discussed, and a summary of the discussion; (3) Inform the competent patient or authorized decision maker that the MOLST form will become part of the medical record and can be accessed through the procedures used to access a medical record; and (4) Give the patient or authorized decision maker a copy of the completed form within 48 hours or sooner if the patient is discharged or transferred. F. A practitioner who completes or updates a MOLST form shall do so in accordance with the form’s instructions. G. Except as otherwise provided in the Health Care Decisions Act, a practitioner shall complete, or update a MOLST form in a manner that is consistent with: (1) The known decisions of: (a) A competent patient; or (b) An authorized decision maker; and (2) Any known advance directive if the patient is incapable of making an informed decision. H. Any individual may request that a health care facility complete a MOLST form on his or her behalf, even if completion of a MOLST form is not required under these regulations or otherwise required by law. A health care facility that completes a MOLST form under these circumstances shall provide a copy of the completed form within 48 hours to the individual requesting completion of the form. #### Regulation .05 Resolving Conflicts Between MOLST Forms. *COMAR 10.01.21.05* A. If the medical records of a patient contain more than one MOLST form, the orders contained in the most recent MOLST form shall be followed unless and until the form is updated. B. If MOLST forms completed on different dates contain conflicting orders, a health care provider shall: (1) To the extent feasible, discuss any conflicts with the patient or authorized decision maker; and (2) Complete an updated MOLST form to reflect the current wishes of the patient or authorized decision maker. C. If an updated MOLST form is completed, all older forms shall be voided in accordance with the form’s instructions. #### Regulation .06 Reproduction and Alteration of the MOLST Form. *COMAR 10.01.21.06* A. A health care provider may freely copy, store electronically, and subsequently print or otherwise reproduce the form. B. A health care provider may not alter the contents or format of the form. #### Regulation .07 Immunity. *COMAR 10.01.21.07* A health care provider that, in good faith, authorizes the provision, withholding, or withdrawing of treatment in furtherance of orders contained in a MOLST form is entitled to the immunity provided under Health-General Article, §5-609, Annotated Code of Maryland. ### Chapter 22 — Maryland Loan Assistance Repayment Program for Physicians and Physician Assistants **Authority:** Health-General Article, §24–1701—24-1708, ; and Health Occupations Article, §§14–207 and 15–206(c), Annotated Code of Maryland **Administrative History:** Effective date: March 2, 2026 (53:4 Md. R. 184) #### Regulation .01 Purpose. *COMAR 10.01.22.01* The purpose of the Maryland Loan Assistance Repayment Program for Physicians and Physician Assistants is to improve health care access for all Marylanders by recruiting and retaining health care providers in areas of Maryland with health care professional shortages through education loan repayments assistance to program participants. #### Regulation .02 Definitions. *COMAR 10.01.22.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Education loan” has the meaning stated in Health-General Article, §24-1701, Annotated Code of Maryland. ​ (3) “Eligible field of employment” has the meaning stated in Health-General Article, §24–1704, Annotated Code of Maryland. (4) “Full-time” means an individual’s work week consists of 40 or more hours at an eligible practice site. (5) “Guidelines” means the Maryland Loan Repayment Programs Guidelines and any subregulatory guidance established by the Department. (6) “Medical resident” means an individual who has completed medical school and is participating in a post-graduate residency education program accredited by the Accreditation Council for Graduate Medical Education, or its successor, or the American Osteopathic Association, or its successor, who is not licensed to practice medicine in the State. (7) “Participant” means an individual who has been offered a Program award and is under a service obligation with the Program. (8) “Part-time” means an individual’s work week consists of between 20 to 39 hours at an eligible practice site. (9) “Physician” has the meaning stated in Health-Occupations Article, §14-101, Annotated Code of Maryland, who practices medicine either full-time or part-time. (10) “Physician assistant” has the meaning stated in Health-Occupations Article, §15-101, Annotated Code of Maryland, who practices full-time or part-time. (11) “Practice site” means a site where a participant provides clinical services and fulfills their service obligation. (12) “Primary care” has the meaning stated in Health-General Article, §24-1701, Annotated Code of Maryland. (13) “Program” means the Maryland Loan Assistance Repayment Program for Physicians and Physician Assistants. (14) “Promissory Note” means a contractual agreement between a participant and the Department describing disbursement methods, participant roles and responsibilities, compliance penalties, and other terms as determined by the Department. (15) “Service Obligation Agreement” means a contractual agreement between a participant and the Department specifying participant service obligations, total and annual Program award amounts, required data and verifications, penalties for breach, and other terms as determined by the Department. #### Regulation .03 Program Eligibility. *COMAR 10.01.22.03* A. Eligibility. To be eligible for the program the individual shall: (1) Meet the licensure requirements set forth in §B of this regulation; (2) Be a United States citizen or national; (3) Be liable and personally owe educational debt; (4) Have a valid employment contract with an eligible practice site in the State that will be in effect by the start of any service obligation to be fulfilled; (5) Provide evidence of practice as either part-time or full-time at that eligible practice site; (6) Practice full-time or part-time providing health care services at an eligible practice site, with at least 80 percent of time spent in direct patient care for a minimum of 45 weeks per year; and (7) Utilize Program funds for the repayment of eligible education loans. B. Licensure Requirements. To be eligible for the program, an individual shall be one of the following: (1) A physician possessing active and valid licensure without restrictions or encumbrances to practice Allopathic Medicine in the State; (2) A physician possessing active and valid licensure without restrictions to or encumbrances to practice Osteopathic Medicine in the State; (3) A physician assistant possessing active and valid licensure without restriction or encumbrances in the State; or (4) A final year medical resident who is specializing in primary care and overseen by a postgraduate training program in the State. C. Eligibility Restrictions. An individual may not be eligible for the Program if they have: (1) A federal or state judgment lien; (2) Defaulted on any federal or state payment obligations even if the governmental creditor now considers them to be in good standing; (3) Breached a prior service obligation to federal, state, or local government or other entity, even if the obligation is subsequently satisfied; (4) Any federal or non-federal debt written off as uncollectible or received a waiver of any service or payment obligation; (5) Any outstanding contractual obligations for a health care professional service to the federal government, another state loan repayment program, or other entity unless those service obligations are completely satisfied prior to the commencement of the Program service obligation; and (6) Received the two maximum awards for service obligations to the Program. D. Eligible Practice Sites. An eligible practice site shall: (1) Be an eligible field of employment in accordance with Health-General Article, §24–1704, Annotated Code of Maryland; (2) Be physically located in the State; (3) Provide services to all patients regardless of their ability to pay; and (4) If the practice site charges for health care professional services: (a) Charge at the usual and customary prevailing rate; (b) Utilize a financial aid policy of discounts or sliding fee scale for individuals with limited incomes; and (c) Accept reimbursement from Medicare, the Maryland Medical Assistance Program, and the Maryland Children’s Health Insurance Program, if applicable to the patient type. #### Regulation .04 Application Procedures. *COMAR 10.01.22.04* A. By the published deadlines, on the form designated by the Department, an applicant shall: (1) Submit a complete application to the Department; (2) Facilitate submission of application components by all contributors; and (3) Submit any supporting documentation as requested by the Department. B. The Department shall disapprove an application if the application: (1) Fails to provide sufficient information or comply with requested documentation; (2) Has the appropriate documentation but is determined to be ineligible; or (3) Does not satisfy the requirements established by law or the Department. #### Regulation .05 Participant Selection. *COMAR 10.01.22.05* A. The Department shall: (1) Assess applicant eligibility based on documentation received by the published deadline; (2) Require from an applicant additional documentation or use independent verification means to verify information in the application; and (3) Score an eligible application based on priority criteria in accordance with: (a) Health-General Article, §24–1705, Annotated Code of Maryland; and (b) The guidelines established by the Department. B. An applicant shall respond to an award offer by submitting all required documentation to the Department within 90 calendar days of notice of award. C. Failure of the applicant to provide required documentation shall result in: (1) An application determined as ineligible; or (2) Cancellation of any offered awards. D. Appeal of Disapproval of Application. (1) An applicant may appeal the decision to disapprove an application by submitting an appeal request in writing to the Department within 30 calendar days of the date on the notice of the disapproved application. (2) If an applicant submits an appeal, the Department, within 60 calendar days, shall: (a) Sustain or reverse the decision on the application; and (b) Provide written notice to the applicant: (i) Indicating whether the decision on the application has been sustained or reversed; and (ii) Providing an explanation of the decision. (3) An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s disapproval of an application as stated in §D(2) of this regulation. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03. (4) Failure to be present for the hearing without prior notice, communication, or approval from the Department may result in: (a) The appeal nullified and decision sustained; (b) Hearing on the appeal not rescheduled; or (c) Appropriate sanctions taken as deemed by the Department. #### Regulation .06 Award Distribution. *COMAR 10.01.22.06* A. The distribution of Program awards shall be based on the funding prioritization in accordance with Health-General Article, §24–1704(b), Annotated Code of Maryland. B. The Department shall prioritize funding for the repayment of education loans in accordance with Health-General Article, §24–1705(b), Annotated Code of Maryland. C. The Department shall annually determine, based on the availability of funds: (1) The maximum number of participants for the Program in each priority area; and (2) The minimum and maximum amount of loan repayment assistance awarded. D. The amount of award offered and paid shall not exceed the lesser of: (1) The loan repayment amount specified in the Service Obligation Agreement; or (2) A participant's total verified debt from eligible education loans. #### Regulation .07 Participant Obligation. *COMAR 10.01.22.07* A. A participant shall provide the Department with required documentation including: (1) Lender verification of education loan balance; (2) Documentation of employer verification; (3) A signed Promissory Note that includes: (a) The disbursement methods utilized by the Department in the repayment of education loans; (b) The roles and responsibilities of the participant in the disbursement of funds to the lender institution; (c) Penalties for failing to comply with terms and conditions of agreements with the Department; and (d) Other terms as determined by the Department; (4) A Service Obligation Agreement that includes: (a) Obligations of the participant; (b) Total and annual amounts of the Program award; (c) Completion of data and verifications required by the Department; (d) Penalties for breach of the Promissory Note and Service Obligation Agreements; (e) Incorporation of the Promissory Note and Program Guidelines; and (f) Other appropriate terms as determined by the Department; and (5) All other documentations as requested by the Department. B. A participant shall: (1) Continue to meet the eligibility requirements as stated in Regulation .03A and B of this chapter; and (2) Serve a minimum service obligation as stipulated in the Service Obligation Agreement with the Department. C. A final year medical resident shall: (1) Meet all requirements set forth in §A of this regulation; (2) Complete residency training in primary care, and begin their service obligation without interruption; and (3) Fulfill all requirements of §B of this regulation once the service obligation commences. #### Regulation .08 Verification of Service Obligation Fulfillment. *COMAR 10.01.22.08* A. The Department shall verify annually during Program participation, the participant’s compliance with: (1) The Program Promissory Note; (2) The Service Obligation Agreement; and (3) Any subregulatory guidelines developed by the Department. B. A participant shall respond to annual verification by submitting all required documentation to the Department within 180 calendar days of request. C. The Department shall annually receive confirmation from the: (1) Approved practice site that the participant provided services in the previous year and continues to practice at the practice site; and (2) Lender institution that the participant has an outstanding education loan balance that is not in default. D. For a medical resident in their final year of medical residence, prior to the disbursement of award payment for the first obligation cycle, the Department shall: (1) Receive confirmation from the residency training program that the participant is specializing in primary care; and (2) Follow the same verification procedures stated in §§A and B of this regulation once service obligations by the participant commences. E. Failure to provide required reverification documentation to the Department will constitute a breach of agreement with the Department. #### Regulation .09 Breach of Agreement and Penalties. *COMAR 10.01.22.09* A. A participant's failure to comply with the Service Obligation Agreement and Promissory Note shall constitute a breach of agreement with the Department. B. A final year medical resident who fails to begin a service obligation at the start of the next obligation cycle following the completion of primary care residency training, shall be in breach of the Service Obligation Agreement and Promissory Note. C. Penalties for breach of agreement with the Department shall be stated in the Service Obligation Agreement and Promissory Note, and may include: (1) Financial penalties dependent on the funding source of the award provided to the participant; (2) The elimination of future eligibility for the Program; or (3) Referral of the participant to the Maryland Board of Physicians for investigation of the participant's violation of breach of service obligation. #### Regulation .10 Amendments to a Participant’s Service Obligation. *COMAR 10.01.22.10* A. Practice Site Transfer. (1) The Department may consider practice site transfer requests during a participant’s service obligation period. (2) A participant shall submit a site transfer request to the Department for consideration and receive approval of the site transfer from the Department prior to a participant’s separation from an approved practice site. (3) A site transfer request may not be submitted until the second service obligation year. B. The Department may consider deferment of a participant’s service obligation or payment obligation for up to 1 year, if determined by the Department that compliance by the participant with the terms and conditions of the Service Obligation Agreement would involve extreme hardship as evidenced through documentation provided to the Department. C. Any request by a participant for service obligation amendments shall follow the written process and procedures as established by the Department in subregulatory guidance. D. A decision made by the Department upon request for a service obligation amendment shall be final. E. The Department may consider cancellation of a participant service obligation with evidence under the following circumstances: (1) Illness or injury that prohibits future possibility of service; or (2) Death as determined by a death certificate or other conclusive evidence of death under State law. ### Chapter 23 — Maryland Loan Assistance Repayment Program for Nurses and Nursing Support Staff **Authority:** Health-General Article, §§24–1901—24-1906, Annotated Code of Maryland **Administrative History:** Effective date: March 2, 2026 (53:4 Md. R. 185) #### Regulation .01 Purpose. *COMAR 10.01.23.01* The purpose of the Maryland Loan Assistance Repayment Program for Nurses and Nursing Support Staff is to improve access to care for all Marylanders by recruiting and retaining health care providers in health care professional shortage areas of Maryland through the provision of education loan repayment assistance to eligible participants in exchange for their service obligations. #### Regulation .02 Definitions. *COMAR 10.01.23.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Education loan” has the meaning stated in Health-General Article, §24-1901, Annotated Code of Maryland. ​ (3) “Eligible field of employment” has the meaning stated in Health-General Article, §24–1904, Annotated Code of Maryland. (4) “Full-time” means an individual’s work week consists of 40 or more hours at an eligible practice site. (5) “Guidelines” means the Maryland Loan Repayment Programs Guidelines and any subregulatory guidance established by the Department. (6) “Nurse” has the meaning stated in Health-General Article, §24–1901, Annotated Code of Maryland. (7) “Nursing Support Staff” has the meaning stated in Health-General-Article, §24–1901, Annotated Code of Maryland. (8) “Participant” means an individual who has been offered a Program award and is under a service obligation. (9) “Part-time” means an individual’s work week consists of between 20 to 39 hours at an eligible practice site. (10) “Practice site” means a site where a participant provides clinical services and fulfills their service obligation. (11) “Program” means the Maryland Loan Assistance Repayment Program for Nurses and Nursing Support Staff. (12) “Promissory Note” means a contractual agreement between a participant and the Department describing disbursement methods, participant roles and responsibilities, compliance penalties, and other terms as determined by the Department. (13) “Service Obligation Agreement” means a contractual agreement between a participant and the Department specifying participant service obligations, total and annual Program award amounts, required data and verifications, penalties for breach, and other terms as determined by the Department. #### Regulation .03 Program Eligibility. *COMAR 10.01.23.03* A. Eligibility. To be eligible for the Program, a nurse or nursing support staff shall: (1) Be liable and personally owe education loan debt; (2) Be a United States citizen or national; (3) Have a valid employment contract with an eligible practice site in the State that will be in effect by the start of any service obligation to be fulfilled; (4) Provide evidence of practice as either part-time or full-time at the eligible practice site; (5) Practice full-time or part-time providing health care services at an eligible practice site, with at least eighty percent of time spent in direct patient care for at least a minimum of 45 weeks per year; (6) Utilize Program funds for the repayment of eligible education loans; and (7) Possess an active and valid certificate or license to practice nursing or fulfill a nursing support staff role in the State, without restrictions or encumbrances. B. Eligibility Restrictions. To be eligible for the Program, a nurse or nursing support staff may not have: (1) Federal or State judgment liens; (2) Defaulted on any federal or State payment obligations even if the governmental creditor now considers them to be in good standing; (3) Breached a prior service obligation to federal, State, or local government or any other entity, even if the obligation is subsequently satisfied; (4) Any federal or non-federal debt written off as uncollectible or received a waiver of any service or payment obligation; (5) Any outstanding contractual obligations for health care professional service to the federal government, another state loan repayment program, or other entities unless those service obligations are completely satisfied prior to the commencement of the Program service obligation; and (6) Received the two maximum awards for service obligations to the Program. C. Eligible Practice Sites. An eligible practice site shall: (1) Be an eligible field of employment in accordance with Health-General Article, §24–1904, Annotated Code of Maryland; (2) Be physically located in the State; (3) Provide services to all patients regardless of their ability to pay; (4) If the practice site charges for health care professional services: (a) Charge at the usual and customary prevailing rate; (b) Utilize a financial aid policy of discounts or sliding fee scale for individuals with limited incomes; and (c) Accept reimbursement from Medicare, the Maryland Medical Assistance Program, and the Maryland Children’s Health Insurance Program, if applicable to the patient type. #### Regulation .04 Application Procedures. *COMAR 10.01.23.04* A. By the published deadline, on the form designated by the Department, an applicant shall: (1) Submit a complete application to the Department; (2) Facilitate submission of application components by all contributors; and (3) Submit any supporting documentation as requested by the Department. B. The Department shall disapprove an application if the application: (1) Fails to provide sufficient information or comply with requested documentation; (2) Has the appropriate documentation but is determined to be ineligible; or (3) Does not satisfy the requirements established by law or the Department. #### Regulation .05 Participant Selection. *COMAR 10.01.23.05* A. The Department shall: (1) Assess applicant eligibility based on documentation received by the published deadline; (2) Require from an applicant additional documentation or use independent verification means to verify information in the application; and (3) Score an eligible application based on priority criteria in accordance with: (a) Health-General Article, §24–1905, Annotated Code of Maryland; and (b) The guidelines established by the Department. B. An applicant shall respond to an award offer by submitting all required documentation to the Department within 90 calendar days of notice of award. C. Failure of the applicant to provide required documentation shall result in: (1) An application determined as ineligible; or (2) Cancellation of any offered award. D. Appeal of Disapproval of Application. (1) An applicant may appeal the decision to disapprove an application by submitting an appeal request in writing to the Department within 30 calendar days of the date on the notice of the disapproved application. (2) If an applicant submits an appeal, the Department, within 60 calendar days, shall: (a) Sustain or reverse the decision on the application; and (b) Provide written notice to the applicant: (i) Indicating whether the decision on the application has been sustained or reversed; and (ii) Providing an explanation of the decision. (3) An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s disapproval of an application as stated in §D(2) of this regulation. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03. (4) Failure to be present for the hearing without prior notice, communication, or approval from the Department may result in: (a) The appeal nullified and decision sustained; (b) Hearing on the appeal not rescheduled; or (c) Appropriate sanctions taken as deemed by the Department. #### Regulation .06 Award Distribution. *COMAR 10.01.23.06* A. The distribution of program awards shall be based on the funding prioritization in accordance with Health-General Article, §24-1904.1(a), Annotated Code of Maryland. B. The Department shall prioritize funding for the repayment of education loans in accordance with Health-General Article, §24–1904.1(b), Annotated Code of Maryland. C. The Department shall annually determine, based on the availability of funds: (1) The maximum number of participants for the Program in each priority area; and (2) The minimum and maximum amount of loan repayment assistance awarded. D. The amount of award offered and paid shall not exceed the lesser of: (1) The loan repayment amount specified in the Service Obligation Agreement; or (2) A participant's total debt from eligible education loans. #### Regulation .07 Participant Obligation. *COMAR 10.01.23.07* A. A participant shall provide the Department with required documentation including: (1) Lender verification of education loan balance; (2) Documentation of employer verification; (3) A signed Promissory Note that includes; (a) The disbursement methods utilized by the Department in the repayment of education loans; (b) The roles and responsibilities of the participant in the disbursement of funds to the lender institution; (c) Penalties for failing to comply with terms and conditions of agreements with the Department; and (d) Other terms as determined by the Department; (4) A Service Obligation Agreement that includes; (a) Obligations of the participant; (b) Total and annual amounts of the Program award; (c) Completion of data and verifications required by the Department; (d) Penalties for breach of the Promissory Note and Service Obligation Agreements; (e) Incorporation of the Promissory Note and Program Guidelines; and (f) Other appropriate terms as determined by the Department; and (5) All other documentation as required by the Department. B. A participant shall: (1) Continue to meet the eligibility requirements as stated in Regulation 03A and B of this chapter; and (2) Serve a minimum service obligation as stipulated in the Service Obligation Agreement with the Department. #### Regulation .08 Verification of Service Obligation Fulfillment. *COMAR 10.01.23.08* A. The Department shall verify annually during Program participation, the participant’s compliance with: (1) The Program Promissory Note; (2) The Service Obligation Agreement; and (3) Any subregulatory guidelines developed by the Department. B. A participant shall respond to annual verification by submitting all required documentation to the Department within 180 calendar days of request. C. The Department shall annually receive confirmation from the: (1) Approved practice site that the participant provided services in the previous year and continues to practice at the practice site; and (2) Lender institution that the participant has an outstanding education loan balance that is not in default. D. Failure to provide required reverification documentation to the Department will constitute a breach of agreement with the Department. #### Regulation .09 Breach of Agreement and Penalties. *COMAR 10.01.23.09* A. A participant's failure to comply with the Service Obligation Agreement and Promissory Note shall constitute a breach of agreement with the Department. B. Penalties for breach of agreement with the Department shall be stated in the Service Obligation Agreement and Promissory Note, and may include: (1) Financial penalties dependent on the funding source of the award provided to the participant; (2) The elimination of future eligibility for the Program; or (3) Referral of the participant to the Maryland Board of Nursing for further disciplinary actions. #### Regulation .10 Amendments to a Participant’s Service Obligation. *COMAR 10.01.23.10* A. Practice Site Transfer. (1) The Department may consider practice site transfer requests during a participant’s service obligation period. (2) A participant shall submit a site transfer request to the Department for consideration and receive approval of the site transfer from the Department prior to a participant’s separation from an approved practice site. (3) A site transfer request may not be submitted until the second service obligation year. B. The Department may consider deferment of a participant’s service obligation or payment obligation for up to 1 year if determined by the Department that compliance by the participant with the terms and conditions of the Service Obligation Agreement would involve extreme hardship as evidenced through documentation provided to the Department. C. Any request by a participant for service obligation amendments shall follow the written process and procedures as established by the Department in subregulatory guidance. D. A decision made by the Department upon request for a service obligation amendment shall be final. E. The Department may consider cancellation of a participant service obligation with evidence under the following circumstances: (1) Illness or injury that prohibits future possibility of service; or (2) Death as determined by a death certificate or other conclusive evidence of death under State law. ## Subtitle 02 — Division of Reimbursements ### Chapter 01 — Charges for Services Provided Through the Maryland Department of Health **Authority:** Health-General Article, §§16-201—16-407, Annotated Code of Maryland **Administrative History:** Effective date: January 6, 1976 (3:4 Md. R. 215) **Administrative History:** Promulgated as emergency provision April 14, 1976 (3:11 Md. R. 586) **Administrative History:** Regulations .01—.07 amended effective July 21, 1976 (3:15 Md. R. 791) **Administrative History:** Regulation .02 amended effective May 5, 1986 (13:9 Md. R. 1027) **Administrative History:** Regulation .04 amended as an emergency provision effective March 18, 1985 (12:7 Md. R. 693); adopted permanently effective June 3, 1985 (12:11 Md. R. 1047) **Administrative History:** Regulation .04 amended as an emergency provision effective November 14, 1985 (12:25 Md. R. 2468); adopted permanently effective April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .04 amended effective May 5, 1986 (13:9 Md. R. 1027) **Administrative History:** Regulation .04A amended effective March 23, 1987 (14:6 Md. R. 714); June 27, 1988 (15:13 Md. R. 1552); April 1, 1991 (18:6 Md. R. 685) **Administrative History:** Regulations .05A and .07A amended effective May 5, 1986 (13:9 Md. R. 1027) **Administrative History:** Chapter revised as an emergency provision effective July 1, 1995 (22:15 Md. R. 1112); revised permanently effective October 9, 1995 (22:20 Md. R. 1543) **Administrative History:** Regulation .03 amended as an emergency provision effective June 29, 1996 (23:15 Md. R. 1080); amended permanently effective November 4, 1996 (23:22 Md. R. 1496) **Administrative History:** Regulation .03D amended as an emergency provision effective November 14, 1997 (24:25 Md. R. 1717); amended permanently effective February 23, 1998 (25:4 Md. R. 243) **Administrative History:** Regulation .03D amended as an emergency provision effective September 14, 1998 (25:21 Md. R. 1571); amended permanently effective December 28, 1998 (25:26 Md. R. 1923) **Administrative History:** Chapter revised as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); revised permanently effective March 19, 2001 (28:05 Md. R. 551) **Administrative History:** Chapter revised effective August 17, 2015 (42:15 Md. R. 1055) **Administrative History:** Regulation .04B amended effective February 27, 2017 (44:4 Md. R. 252) #### Regulation .01 Purpose. *COMAR 10.02.01.01* It is the intent of this chapter that: A. The cost of care of a recipient of services be determined in accordance with the charges for health services set under this chapter; B. There be a single or, if appropriate, bundled charge for each health service rendered to an individual, including an individual in a group session or family group session; and C. The methods for determining full costs be uniform among all units. #### Regulation .02 Scope. *COMAR 10.02.01.02* This chapter applies to: A. All inpatient facilities operated by the Department; B. All local health departments' programs funded by the Department; C. All private or public alcohol and drug abuse providers funded by the Behavioral Health Administration; D. Adult day care funded by the Office of Health Services; and E. Family planning services funded by the Prevention and Health Promotion Administration. #### Regulation .03 Definitions. *COMAR 10.02.01.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Charge” means the dollar amount set or approved by the Secretary for each clinic visit, day of care, hour, procedure, or other unit of service, as specified in the Schedule of Charges, which is the single rate to be charged all recipients of service, estates, third-party payers and insurers, or chargeable persons. (2) “Chargeable person” means: (a) Any responsible relative of a recipient of services; (b) Except for a recipient of services, any other person who is legally responsible for the cost of care of the individual; and (c) Any person who maintains a policy of health insurance under which a recipient of services is insured. (3) “CPT” means a Current Procedural Terminology listing descriptive terms and identifying codes for reporting clinical services and procedures. (4) “Daily per capita inpatient cost of care” means the cost of providing a day of care at a State-operated inpatient facility. (5) “Department” means the Maryland Department of Health. (6) “Division” means the Cost Accounting and Reimbursement Division of the Department. (7) Federal Indirect Cost. (a) “Federal indirect cost” means the cost the federal government recognizes as the costs of operating an inpatient facility that are not directly attributable to the operation of the inpatient facility. (b) “Federal indirect cost” includes costs which benefit the Department as a whole and the inpatient facility indirectly, but cannot be readily identified with the inpatient facility without disproportionate effort. (8) “Fee” means the charge or that part of the charge after an ability-to-pay determination or the elimination of disallowed costs by any third-party payer or insurer. (9) “Health service” means any service for which a charge is established that is provided to any person, client, or resident in or by a unit of the Department, political subdivision, or grantee which is deemed appropriate by that unit to the care and treatment of an individual under its care or enrolled in its program. (10) “Local health department” means a governmental agency that: (a) Is funded wholly or partly by the Department; (b) Assumes legal and financial responsibility and accountability both for funds awarded by the Department and for the provision of health services; and (c) Operates under the general direction of a health officer who is duly appointed by and reports to the Secretary pursuant to Health-General Article, Title 3, Subtitle 3, Annotated Code of Maryland. (11) “Medical Assistance ” means the Maryland Medical Assistance Program, which is administered by the State and pays the medical bills of certain needy and low-income individuals pursuant to Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland, and 42 U.S.C. Chapter 7, Subchapter XIX. (12) “Non-inpatient related costs” means costs at a State-operated facility which do not relate to the delivery of inpatient care. (13) “Out-of-network services” means health services that are provided to a recipient of services which are not subject to payment at a negotiated rate under an agreement between the provider and a public or private third-party payer or insurer for the recipient of services. (14) “Private provider” means: (a) All private or non-local health department alcohol and drug abuse service providers funded by the Behavioral Health Administration; (b) Adult day care service providers funded by the Office of Health Services; and (c) Family planning service providers funded by the Prevention and Health Promotion Administration. (15) “Provider” means a facility operated by: (a) The Department; (b) A local health department; or (c) A private provider. (16) Recipient of Services. (a) “Recipient of services” means an individual who receives care, maintenance, treatment, or support from a facility, clinic, local health department, program, or other entity that is operated or funded wholly or partly by the Department. (b) “Recipient of services” includes, but is not limited to an individual: (i) In a public facility under Health-General Article, Title 10, Annotated Code of Maryland; (ii) In a facility or Veterans' Administration hospital for comprehensive evaluation under Health-General Article, Title 7, Annotated Code of Maryland; (iii) In a residential public facility or a facility from which this State obtains residential care under Health-General Article, Title 7, Annotated Code of Maryland; and (iv) To whom juvenile screening or treatment services are provided under Human Services Article, §9-227(b)(1)(ii), Annotated Code of Maryland. (17) “Responsible relative” means one or more of the following who are legally responsible for the cost of care of a recipient of services: (a) The spouse of the recipient of services; (b) A parent of the recipient of services who is a minor; and (c) An adult child of the recipient of services. (18) “Schedule of charges” means a list of charges for health services as determined pursuant to instructions provided by the Division and this chapter, and set or approved by the Secretary. (19) “Secretary” means the Secretary of Health. (20) “Shared costs” means costs arising out of shared functions between two State-operated inpatient facilities. (21) Statewide and Departmental Overhead. (a) “Statewide and departmental overhead” means those costs incurred by the State and allocated to the facility which benefit the State-operated inpatient facility's operation as a whole, but are not related to the delivery of direct patient care. (b) “Statewide and departmental overhead” includes costs that are usually incurred for a common purpose benefiting the State-operated inpatient facility which are not readily identified with the State-operated inpatient facility without disproportionate effort, such as Statewide accounting, purchasing, and personnel functions. (22) “Third-party payer disallowance” means the difference between the charge and the payment amount authorized by an agreement between a provider and a public or private third-party payer or insurer. #### Regulation .04 Setting of Charges for Local Health Departments. *COMAR 10.02.01.04* A. The Secretary shall approve a Schedule of Charges for each local health department containing the CPT-based charges for health services provided by the local health department which remain in effect until changed as provided in this chapter. B. CPT-Based Charge. (1) Each health service for which payment is sought shall be assigned an applicable CPT code. (2) Approved Method for Determining CPT-Based Charges. (a) The CPT-based charge for each health service shall be equivalent to 150 percent of the Medicare participating provider fee allowance for the corresponding CPT code in the most recent Medicare Physician’s Fee Schedule for Maryland or the Washington, DC, suburbs, as appropriate, which is updated annually in the Federal Register by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, in accordance with 42 U.S.C. §1395w-4. (b) For any health service performed by a local health department for which a rate is not assigned in the applicable Medicare Physicians Fee Schedule, the CPT-based charge shall be equivalent to 150 percent of the Maryland Medical Assistance participating provider fee allowance for the corresponding CPT code in the Professional Services Provider Manual and Fee Schedule, as published by the Department and incorporated by reference in COMAR 10.09.02.07D. (c) For any health service performed by a local health department for which a rate is not assigned on the applicable Medicare Physicians Fee Schedule or in the Professional Services Provider Manual and Fee Schedule, the CPT-based charge shall be equivalent to the average hourly rate of the employees providing the service to the recipients of services, calculated based upon current fiscal year salaries and fringe benefits, multiplied by the projected time of service with recipient of services, plus 20 percent for indirect costs. C. Revisions and modifications to a Schedule of Charges shall be made and approved by the Secretary pursuant to instructions issued by the Division, provided that the Schedule of Charges for each local health department is updated and approved by the Secretary at least annually. D. Each approved Schedule of Charges, with all revisions and modifications, shall be retained by the Division and also be prominently posted at each location of the local health department where health services are provided. #### Regulation .05 Setting of Charges for State-Operated Inpatient Facilities. *COMAR 10.02.01.05* A. Inpatient Charge. (1) For each fiscal year, a daily per capita inpatient cost of care for a State-operated inpatient facility shall be determined by: (a) Utilizing the legislatively approved budget for the inpatient facility; (b) Adding the federal indirect cost and Statewide and departmental overhead, less shared cost, for the applicable fiscal year; and (c) Dividing the amount determined in §A(1)(b), of this regulation, by the average daily population of the facility for the applicable fiscal year to arrive at the daily per capita inpatient cost of care for the facility. (2) The per diem inpatient charge shall equal the daily per capita inpatient cost of care as determined in §A(1)(c) of this regulation. (3) The per diem inpatient charge shall be set forth in the Schedule of Charges. B. Medicare-Eligible Patient Charge. (1) For each fiscal year, a Medicare daily per capita inpatient cost of care for a State-operated inpatient facility shall be determined by: (a) Utilizing the legislatively approved budget for the inpatient facility, minus the cost of physician and ancillary services for the inpatient facility; (b) Adding the federal indirect cost and Statewide and departmental overhead, less shared cost, for the applicable fiscal year; and (c) Dividing the amount determined in §B(1)(b), of this regulation, by the average daily population of the facility for the applicable fiscal year to arrive at the Medicare daily per capita inpatient cost of care for the facility. (2) The per diem Medicare-eligible inpatient charge shall equal the Medicare daily per capita inpatient cost of care as determined in §B(1)(c) of this regulation. (3) The per diem Medicare-eligible inpatient charge shall be set forth in the Schedule of Charges. C. Physician Charge. (1) For each fiscal year, a charge of physician services provided at a Medicare-eligible State-operated inpatient facility shall be determined by utilizing the most recent Facility Medicare Physicians fee schedule for Maryland or Washington, D.C., suburbs as appropriate, which is updated annually in the Federal Register by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, pursuant to 42 U.S.C §1395w-4. (2) The physician charge shall be set forth in the Schedule of Charges. D. Ancillary Charge. (1) For each fiscal year, a charge for ancillary services provided at a Medicare-eligible State-operated inpatient facility shall be determined by utilizing the most recent Facility Medicare Physicians fee schedule for Maryland or Washington, D.C., suburbs as appropriate, which is updated annually in the Federal Register by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, pursuant to 42 U.S.C §1395w-4. (2) The ancillary charge shall be set forth in the Schedule of Charges. E. Charges for State-operated inpatient facilities shall be based on the best estimate of costs, including all appropriate indirect costs, according to generally accepted cost accounting practice. State-operated inpatient facilities, in support of the proposed Schedule of Charges, shall report the estimate of costs in the form required by the Secretary. When the dollar amount is set by statute, the Schedule of Charges shall specify that amount. F. Revisions and modifications to the approved Schedule of Charges to reflect changes in charges or the addition of new services shall be made when recommended by the Division and approved by the Secretary. G. The approved Schedule of Charges, with all revisions and modifications, shall be retained in the Office of the Secretary and also be available for public inspection in the Superintendent's office of the State-operated inpatient facility. #### Regulation .06 Setting of Charges for Private Providers. *COMAR 10.02.01.06* A. A private provider shall submit annually, to the Division, a cost report and proposed recommended Schedule of Charges, pursuant to instructions provided by the Division. B. At least annually, the Secretary shall approve a Schedule of Charges recommended for each private provider containing the per service charges for each private provider which remain in effect until changed as provided in this chapter. C. Per Service Charge. A charge for each service provided shall be determined for each private provider by: (1) Calculating the actual cost for each type of service provided; (2) Adjusting the actual cost determined in §C(1) of this regulation for depreciation and inflation, less equipment cost; and (3) Dividing the amount determined in §C(2) of this regulation by the actual units of service provided. D. If a private provider's service charges are established by the Health Services Cost Review Commission (HSCRC), the requirements of §C of this regulation, do not apply. E. A private provider's proposed service charges shall be based on the best estimate of costs, according to generally accepted cost accounting practices, including all appropriate indirect costs. Private providers, in support of their proposed Schedule of Charges shall report their estimates pursuant to instructions provided by the Division. When specific service charges are set by statute, the Secretary shall approve these service charges consistent with the statute. F. Revisions and modifications to the approved Schedule of Charges to reflect changes in cost estimates or the addition or deletion of services for a private provider shall be made when recommended by the Division and approved by the Secretary. G. The approved Schedule of Charges for a private provider, with all revisions and modifications, shall be retained in the Division and also be prominently posted at each location of the private provider where services are provided. #### Regulation .07 Setting of Charges for Laboratories Administration. *COMAR 10.02.01.07* A. The Laboratories Administration shall submit annually, to the Division, a cost report and proposed recommended Schedule of Charges, pursuant to instructions provided by the Division. B. At least annually, the Secretary shall approve a Schedule of Charges recommended for each type of laboratory service which remains in effect until changed as provided in this chapter. C. Charge for a Laboratory Service. A laboratory service charge shall be determined by: (1) Calculating the total cost of a type of laboratory test which may include, but is not limited to, salary and fringe benefits of staff dedicated to the type of laboratory service, and reagents, supplies, and equipment used in the type of laboratory service; (2) Calculating the total number of units of each type of laboratory test performed; and (3) Dividing the total cost of a type of laboratory test, as determined in §C(1) of this regulation, by the total number of units of each laboratory service, as determined in §C(2) of this regulation. D. Revisions and modifications to the approved Schedule of Charges for the Laboratories Administration shall be made when recommended by the Division, and approved by the Secretary, to reflect changes in cost estimates or the addition of new laboratory services. E. The approved Schedule of Charges for the Laboratories Administration, with all revisions and modifications, shall be retained in the Office of the Secretary and also be posted prominently in the administrative offices of the Laboratories Administration. F. Notwithstanding the procedure for determining a laboratory service charge set forth in §C of this regulation, the Secretary may adjust the Schedule of Charges if deemed to be in the best interest of public health. #### Regulation .08 Determination of Ability to Pay and Fees to be Collected. *COMAR 10.02.01.08* A. For inpatient care rendered in facilities operated by the Department, fees shall be established in conformity with applicable statutory requirements and regulations issued by the Secretary. The following apply: (1) The total cost of care of each recipient of services is, in the first instance, the responsibility of the recipient of services and also the chargeable person as provided in Health-General Article, §16-102(b), Annotated Code of Maryland. Any uncollectible costs for services provided to the recipient shall become the responsibility of the State. (2) In accordance with the provisions of Health-General Article, §16-101 et seq., Annotated Code of Maryland, recipients of services and other chargeable persons shall be jointly and severally liable for payment of inpatient charges as set forth in the Schedule of Charges adopted by the Secretary pursuant to Regulation .05 of this chapter. The Department will bill all recipients of services and chargeable persons on the basis of their available financial resources including insurance and third-party payers, up to but not exceeding the full per capita daily charge for services. B. Outpatient and Community Based Services. (1) For all other services, including outpatient and other community based services, the provisions of this section apply. (2) All recipients of services and chargeable persons shall be liable for payment of the charges as set forth in the Schedule of Charges, subject to the following: (a) For uninsured recipients of services, a waiver or reduction of charges may be granted on a case-by-case basis, following an individual determination of financial need of a recipient of services or chargeable person, based upon criteria set forth by the Secretary pursuant to §B(4) of this regulation; and (b) For insured, in-network recipients of services, liability for payment will be reduced to account for any contractually agreed upon third-party payer disallowance. (3) The Secretary shall issue and revise annually an ability-to-pay method and schedule for use in making an individualized determination of financial need of a recipient of services or chargeable person. The difference between the charge for the services rendered and the fee derived from this schedule shall be an ability-to-pay allowance. (4) All local health departments and other providers shall use the uniform method of determining ability to pay as set forth by the Secretary. (5) In those instances where only a portion of a provider's programs are subject to these regulations and a method of determining ability to pay different from that set forth by the Secretary is used, the different method may be used if approved by the Secretary. (6) Any errors, omissions, or false statements or documents used in the determination of ability to pay or billing of any amounts due, may result in a redetermination of ability to pay and billing of any amounts due. #### Regulation .09 Billing and Collection of Charges and Fees. *COMAR 10.02.01.09* A. Billings and collections for care rendered in State operated inpatient facilities shall be calculated by the Department in accordance with the following procedures: (1) The Department shall conduct a financial investigation of a recipient of services or chargeable persons' ability-to-pay in accordance with the requirements of COMAR 10.04.02.03 and COMAR 10.04.02.04; (2) Based on the foregoing investigation, the Department shall prepare a Notice of Rate Establishment Form setting forth that portion of those charges for which the recipient of services or chargeable person shall be responsible; (3) Upon receipt of the Notice of Rate Establishment, a recipient of services or chargeable person may, within 10 days, request the Division to conduct an informal review of the billing in accordance with COMAR 10.02.03.04, or may note an appeal from the billing in accordance with COMAR 10.02.03.05, or both. B. The Secretary may require each local health department and other provider to submit for approval or modification a plan for billing and collection of charges, fees, and insurance benefits. C. This plan shall set forth: (1) The procedures to be followed in applying the ability-to-pay determination method and schedule; (2) The methods to be used for collecting the charges, fees, and insurance benefits; (3) The methods for receiving and accounting for all sums of money collected; (4) The procedure to be followed in making a reasonable effort to collect unpaid amounts due; and (5) The procedure to write off unpaid amounts due, as appropriate. #### Regulation .10 Distribution and Application of Amounts Collected. *COMAR 10.02.01.10* A. All payments made under the provisions of this subtitle for services rendered through facilities and programs of the Department shall be made to and collected by the Department, and shall be accounted for and deposited into the General Funds of the State Treasury by the Department. B. Local health departments and other providers shall report all funds collected as revenues which are to be treated in accordance with Department or federal grant guidelines or other agreements and contracts under which their programs are funded. #### Regulation .11 Records and Reports Required. *COMAR 10.02.01.11* A. An individual financial record for each recipient of services or chargeable person shall be maintained, which shall contain relevant financial information including: (1) The ability-to-pay determination, including, when available, applicable documents appropriate to the verification of assets, income, expenses, allowances and exemptions; (2) The types and dates of services rendered and the approved charges, the amounts and dates of collections; (3) An indication of the recipient of services eligibility for any federal program providing funding for the services rendered; (4) A signed authorization to release medical information and assignment of third-party benefits; (5) Any other information as may be required by the Secretary from time to time. B. Financial records of fees assessed and collected shall include: (1) Copies of prenumbered receipts; (2) Cash receipts report; (3) Records of deposits; and (4) Other records necessary for proper audit trail. C. The Secretary may waive any of the requirements of this section where appropriate upon written requests supported by reasons and justifications. ### Chapter 02 — Abandonment or Abuse of Responsible Relatives by Recipients of Care **Authority:** Health-General Article, §16-203, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1971 **Administrative History:** Regulations .01, .02B, and .03A amended effective May 5, 1986 (13:9 Md. R. 1028) **Administrative History:** Regulation .03C repealed effective May 5, 1986 (13:9 Md. R. 1028) **Administrative History:** Chapter repealed effective June 27, 1988 (15:13 Md. R. 1552) **Administrative History:** Regulations .01—.03 under a new chapter, Abandonment or Abuse of Responsible Relatives by Recipients of Care, adopted effective June 27, 1988 (15:13 Md. R. 1552) **Administrative History:** Regulation .01 amended effective January 17, 2005 (32:1 Md. R. 27) #### Regulation .01 Definitions. *COMAR 10.02.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Abandonment” means wrongful and continuous absence by a: (a) Spouse from the home for a period of 18 months or longer, immediately before the recipient of services' hospitalization; or (b) Parent coupled with failure to support a child, or children, for a period of 18 months or more during the child's or children's minority. (2) “Abuse” or “physical abuse” means: (a) The sustaining of physical injury; (b) Cruel or inhumane treatment; (c) A malicious act or treatment; or (d) Harm, or threatened harm, to the health or welfare of the individual. (3) “Crime of violence” means: (a) Abduction; (b) Arson; (c) Burglary; (d) Daytime housebreaking; (e) Kidnapping; (f) Manslaughter, except involuntary manslaughter; (g) Assault in the first degree; (h) Murder; (i) Rape; (j) Robbery; (k) Robbery with a deadly weapon; (l) Sexual offense in the first degree; (m) Sexual offense in the second degree; (n) Use of a handgun in the commission of a felony or other crime of violence; (o) An attempt to commit any one of the following offenses: (i) Assault with intent to murder; (ii) Assault with intent to rape; (iii) Assault with intent to rob; (iv) Assault with intent to commit a sexual offense in the first degree; and (v) Assault with intent to commit a sexual offense in the second degree. (4) “Minority” means the period of time when a child is 17 years old or younger. (5) “Recipient of services”: (a) Means an individual who receives care, maintenance, treatment, or support in a facility or program that is operated or funded wholly or partly by the Department; (b) Includes, but is not limited to, an individual in a: (i) Public facility under the Maryland Mental Law, Health-General Article, Title 10, Annotated Code of Maryland; (ii) Facility or Veteran's Administration hospital for comprehensive evaluation under Health-General Article, Title 7, Annotated Code of Maryland; (iii) Residential, public facility, or a facility from which the State obtains residential care under the Maryland Developmental Disabilities Law, Health-General Article, Title 7, Annotated Code of Maryland; and (iv) Facility operated by the Office of Chronic and Rehabilitation Facilities. (6) “Responsible relative” means the: (a) Spouse of a recipient of services; (b) Parents of a recipient of services who is a minor; and (c) Children of a recipient of services. (7) “Sexual abuse”: (a) Means an act that involves sexual molestation or exploitation of a person by another person; (b) Includes, but is not limited to: (i) Incest, rape, or sexual offenses in any degree, (ii) Sodomy, and (iii) Unnatural or perverted sexual practices. #### Regulation .02 Scope. *COMAR 10.02.02.02* It is the policy of the Maryland Department of Health, in accordance with: A. Health-General Article, §16-203(a)(3), Annotated Code of Maryland, to excuse a legally responsible relative from contributing to the cost of in-patient care of a recipient of services if that legally responsible relative has been abandoned by the recipient of services; B. Health-General Article, §16-203(a)(4), Annotated Code of Maryland, to excuse all legally responsible relatives from contributing to the cost of in-patient care of a recipient of services if that recipient of services has committed any of the following actions in relation to any legally responsible relative: (1) Abuse or physical abuse; (2) Crime of violence; or (3) Sexual abuse. #### Regulation .03 Burden of Proof. *COMAR 10.02.02.03* A. A responsible relative claiming to have been abused, sexually abused, abandoned, or subjected to a crime of violence by the recipient of services shall have the burden of establishing to the satisfaction of the Department by a preponderance of the evidence that the legally responsible relative was abandoned, abused, sexually abused, or subjected to a crime of violence by the recipient of services. B. Acceptable evidence for abuse and crimes of violence includes, but is not limited to: (1) Police reports; or (2) Medical records, or medical statements prepared by a physician, physician's assistant, or nurse. C. Acceptable evidence for abandonment includes, but is not limited to, affidavits from disinterested parties of the facts surrounding the abandonment. ### Chapter 03 — Appeal Hearings to the Division of Reimbursements **Authority:** Health-General Article, §2-207, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1971 **Administrative History:** Regulation .01 amended effective June 28, 1999 (26:13 Md. R. 1019) **Administrative History:** Regulations .01, .02C, and .03A amended effective May 5, 1986 (13:9 Md. R. 1028) **Administrative History:** Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .03-1 adopted effective May 5, 1986 (13:9 Md. R. 1028) **Administrative History:** Regulation .04B, C amended effective June 28, 1999 (26:13 Md. R. 1019) **Administrative History:** Regulation .06B amended effective May 5, 1986 (13:9 Md. R. 1028); June 28, 1999 (26:13 Md. R. 1019) **Administrative History:** Regulation .06C amended effective May 5, 1986 (13:9 Md. R. 1028) **Administrative History:** Regulation .08A, C amended effective June 28, 1999 (26:13 Md. R. 1019) #### Regulation .01 Definitions. *COMAR 10.02.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative law judge” means an individual appointed by the Chief Administrative Law Judge under State Government Article, §9-1604, Annotated Code of Maryland, or designated by the Chief Administrative Law Judge under State Government Article, §9-1607, Annotated Code of Maryland. (2) “Appellant” means any individual who requests an appeal hearing for the reasons specified in Regulation .02, of this chapter. (3) “Chargeable person” means any responsible relative and, except for a recipient of services, any other person who is legally responsible in an individual or representative capacity for the care of the individual. (4) “Division” means the Division of Reimbursements of the Maryland Department of Health. (5) Recipient of Services. (a) “Recipient of services” means an individual who receives care, maintenance, treatment, or support in a facility or program that is operated or funded wholly or partly by the Department. (b) “Recipient of services” includes, but is not limited to an individual: (i) In a public facility under Health-General Article, Title 10, Annotated Code of Maryland; (ii) In a facility or Veterans Administration hospital for comprehensive evaluation under the Health-General Article, Title 7, Annotated Code of Maryland; (iii) In a residential, public facility or a facility from which this State obtains residential care under Health-General Article, Title 7, Annotated Code of Maryland; and (iv) In a facility operated under Public Health Services. (6) “Responsible relative” means the: (a) Spouse of a recipient of services; (b) Parents of a recipient of services who is a minor; and (c) Children of a recipient of services. #### Regulation .02 Opportunity for an Appeal Hearing. *COMAR 10.02.03.02* An opportunity for an appeal hearing shall be granted when: A. A rate is established (or increased) against an individual in an amount which is deemed by the individual to be arbitrary and excessive in accordance with the individual's financial circumstances; B. An individual is aggrieved by any division policy, action, or inaction: (1) Which affects the charges established or manner of billing; or (2) Results in an increase in the rates established; C. In the judgment of a recipient of services, responsible relative, or other chargeable person, he or she is adversely affected by any other Division policy, action, or inaction. #### Regulation .03 Notification of Right to Request an Appeal Hearing. *COMAR 10.02.03.03* A. Whenever the Division conducts an investigation of an individual's financial resources and issues a notice of rate establishment for services rendered to a recipient of services in accordance with COMAR 10.02.01.05, the Division shall provide written notification to the individual of his or her right to seek an informal review or an appeal, or both, from the rates established by the Division. B. The notification specified in §A of this regulation shall: (1) Advise the individual of the matters which are the proper subject of an appeal hearing as provided in Regulation .02, of this chapter; (2) Advise the individual of his right to be represented by a lawyer or other person of his choice during the entire hearing process; (3) Advise the individual that he may present witnesses and documents in his behalf at the hearing. #### Regulation .03-1 Request for a Rate Review. *COMAR 10.02.03.03-1* A. If a recipient of services or other chargeable person submits a written request that the Division review the notice of rate establishment, the financial agent for the Division shall: (1) Review the notice of rate establishment to determine the accuracy of the charges established; (2) Review all pertinent information presented by the individual to determine if any adjustments in the billing are appropriate under these regulations; (3) Provide the individual with a final billing statement which indicates both the: (a) Division's position with regard to any written claims for a reduction in the rate established by the Division which are submitted by the individual to the financial agent; and (b) Final rates established by the Division for services rendered to a recipient of services. B. The recipient of services or chargeable person shall have such rights as are set forth in Regulation .05, of this chapter, to request an appeal hearing regarding the Division's informal rate review and the charges for services established by it. In order to note an appeal from the charges established pursuant to the informal rate review, the recipient of services or chargeable person shall follow the procedures as set forth in Regulation .05, of this chapter. #### Regulation .04 Request for an Appeal Hearing. *COMAR 10.02.03.04* A. Any individual, either himself or through a representative, may request an appeal hearing by giving a clear statement, in writing, to any financial agent of the Division that he desires an opportunity to present for review any matter which is the proper subject of an appeal hearing as provided in Regulation .02. This statement shall be forwarded immediately to the Chief of Reimbursements. When the Division receives a request for a hearing, it shall assist the appellant in submitting and processing the request. B. The Division shall promptly acknowledge any request for an appeal hearing and shall thereafter set forth in writing the date, time, and place of the appeal hearing, after consulting with the Office of Administrative Hearings. The acknowledgement shall include the information specified in Regulation .03B of this chapter. C. If any party notifies the Division that the time designated by the Division is not convenient to the party, and requests a different time for the hearing, the Office of Administrative Hearings shall designate another time convenient to the parties if it deems that the party has sufficient reason for requesting the change. D. A request for an appeal hearing may not be granted unless it is made within 30 days of the receipt of the notification specified in Regulation .03A of this chapter or, if Regulation .03A does not apply, within 30 days following the conclusion of the action or inaction which is the subject of the appeal. E. The Division may dismiss a request for an appeal hearing when it has been withdrawn in writing by the appellant or his representative, or abandoned. An appellant shall be deemed to have abandoned his request if he does not appear for the hearing on the established date. #### Regulation .05 Pre-Hearing Procedures. *COMAR 10.02.03.05* The appellant and the Division may request the names of all witnesses that the other party intends to call at the hearing. #### Regulation .06 Hearing Procedures. *COMAR 10.02.03.06* A. The appellant and the Division shall have the opportunity to present witnesses, documentary evidence, and oral and written argument, and to cross-examine all adverse witnesses. B. If the appellant wishes to call as witnesses any of the Division's current employees, or former employees who reside within the State, whose action or inaction is being contested by the appellant or whose testimony is, in the judgment of the appellant, relevant to the issues under consideration, the Office of Administrative Hearings shall require their presence at the hearing. If the appellant has knowledge of the names or other identifying descriptions of the employees before the hearing, the appellant shall supply the Office of Administrative Hearings with the names or other identifying descriptions at least 5 days before the hearing. Subpoenas may be issued under COMAR 28.02.02.11. C. If the Division introduces, as evidence, documents from the case record, special investigation file, or other sources, the appellant shall have the opportunity to examine persons who prepared the documents and to examine the case record or special investigation file for the purpose of discovering information favorable to his case. If these persons are no longer employees of the Division, the appellant shall be permitted to examine a Division representative familiar with the documents and applicable Division policies. #### Regulation .07 The Record. *COMAR 10.02.03.07* A. A recording of the hearing shall be made. A copy of the recording shall be supplied to the appellant whenever the appellant takes a further appeal. The recording, together with all exhibits and papers admitted into evidence, shall constitute the exclusive record for decision. Nonrecorded or confidential information which the appellant does not have an opportunity to hear or see may not be made a part of the hearing record. B. The recording and copies of all exhibits and papers shall remain in the custody of the hearing officer for a period not to exceed 2 years, or until all litigation involving the decision is terminated. #### Regulation .08 Findings, Conclusions and Decisions. *COMAR 10.02.03.08* A. The administrative law judge shall prepare a written summary of findings and conclusions, based exclusively on the record, and shall make a recommendation based on those findings and conclusions. The summary of findings and conclusions shall state the policies, regulations, or laws upon which the decision is based. B. A copy of the findings, conclusions and decisions shall be forwarded to the appellant or his representatives no later than 60 days after the date of the hearing. C. The recommendation of the administrative law judge, after approval by the Secretary of Health, shall be final and binding upon the Division and shall be implemented immediately unless otherwise specifically indicated in the decision. When the hearing decision is favorable to the appellant, or when the Division grants the relief the appellant requests before the hearing decision, the Division, where applicable, shall authorize corrected billing or other relief retroactive to the date the incorrect action was taken. D. The decision, if not favorable to the appellant, may be appealed to the Board of Review as provided by law in Health-General Article, §2-207, Annotated Code of Maryland. E. Subsequent appeals, as provided by law, may be taken by the appellant. ### Chapter 04 — Schedule of Charges for Providers of the Alcohol and Drug Abuse Administration *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1926) **Administrative History:** Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658); December 28, 1987 (14:26 Md. R. 2746); September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528); August 3, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .03B amended effective September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551) ### Chapter 05 — Schedules of Charges for Providers of the Drug Abuse Administration *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1926) **Administrative History:** Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658); December 28, 1987 (14:26 Md. R. 2746) **Administrative History:** Chapter repealed effective September 4, 1989 (16:17 Md. R. 1885) ### Chapter 06 — Schedules of Charges for Health Facilities Operated by or Funded in Whole or in Part by the Laboratories Administration *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1926) **Administrative History:** Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658) **Administrative History:** Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277): repealed permanently effective March 19, 2001 (28:05 Md. R. 551) ### Chapter 07 — Schedule of Charges for Health Facilities Operated by or Funded in Whole or in Part by the Community and Public Health Administration *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1926) **Administrative History:** Regulation .01 amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .03 amended effective April 3, 1989 (16:6 Md. R. 727) **Administrative History:** Regulation .03 amended as an emergency provision effective July 1, 1991 (18:14 Md. R. 1604); amended permanently effective September 30, 1991 (18:19 Md. R. 2099) **Administrative History:** Regulation .03A amended effective August 10, 1987 (14:16 Md. R. 1773); October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .03B amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .03B amended as an emergency provision effective July 1, 1992 (19:14 Md. R. 1311); emergency status extended at 19:20 Md. R. 1812; emergency status expired February 1, 1993 **Administrative History:** Regulation .03B amended effective February 2, 1993 (19:26 Md. R. 2287); October 11, 1993 (20:20 Md. R. 1571) **Administrative History:** Regulation .03B amended as an emergency provision effective July 1, 1993 (20:14 Md. R. 1164) **Administrative History:** Regulation .03B amended as an emergency provision effective July 1, 1994 (21:13 Md. R. 1152); emergency status expired August 9, 1994 (21:18 Md. R. 1506) **Administrative History:** Regulation .03B amended as an emergency provision effective August 10, 1994 (21:18 Md. R. 1505); amended permanently effective November 20, 1994 (21:23 Md. R. 1933) **Administrative History:** Regulation .03B amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1113); amended permanently effective October 9, 1995 (22:20 Md. R. 1543) **Administrative History:** Regulation .03B amended as an emergency provision effective July 1, 1996 (23:14 Md. R. 1006); amended permanently effective October 7, 1996 (23:20 Md. R. 1422) **Administrative History:** Regulation .03 amended and new Regulations .04—.27 adopted as an emergency provision effective August 22, 1997 (24:19 Md. R. 1335); adopted permanently effective November 17, 1997 (24:23 Md. R. 1611) **Administrative History:** Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551) ### Chapter 08 — Schedule of Charges for Providers of the Mental Hygiene Administration *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1927) **Administrative History:** Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2658); December 28, 1987 (14:26 Md. R. 2746); September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .03B amended effective September 4, 1989 (16:17 Md. R. 1885); October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551) ### Chapter 09 — Schedules of Charges for Health Facilities Operated by or Funded in Whole or in Part by the Mental Retardation Developmental Disabilities Administration *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1927) **Administrative History:** Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2659) **Administrative History:** Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551) ### Chapter 10 — Schedules of Charges for Providers of the Office of Chronic and Rehabilitative Facilities *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1928) **Administrative History:** Regulation .03 amended effective September 4, 1989 (16:17 Md. R. 1885) **Administrative History:** Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 2001 (28:5 Md. R. 551) ### Chapter 11 — Schedule of Charges for Providers of the Medical Care Policy Administration *Repealed* **Administrative History:** Effective date: October 7, 1985 (12:20 Md. R. 1928) **Administrative History:** Regulation .01 amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .02B amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Regulation .03 amended effective April 3, 1989 (16:6 Md. R. 728) **Administrative History:** Regulation .03A amended effective December 15, 1986 (13:25 Md. R. 2659); December 28, 1987 (14:26 Md. R. 2746); October 29, 1990 (17:21 Md. R. 2528); October 28, 1991 (18:21 Md. R. 2307) **Administrative History:** Regulation .03B amended effective October 29, 1990 (17:21 Md. R. 2528) **Administrative History:** Chapter repealed as an emergency provision effective December 1, 2000 (27:25 Md. R. 2277); repealed permanently effective March 19, 2001 (28:05 Md. R. 551) ## Subtitle 03 — Health Statistics ### Chapter 01 — Vital Records **Authority:** Family Law Article, §§5-359, 5-3A-42, and 5-3B-29, and Title 5, Subtitle 4B;Health-General Article, §§4-201—4-227 and 13-2207; Annotated Code of MarylandCh.316, Acts of 2016; Public Law 108-458; Public Law 109-13 **Administrative History:** Effective date: October 7, 1963 **Administrative History:** Amended effective January 1, 1965; May 16, 1966; January 1, 1970 **Administrative History:** Regulations .01—.09 repealed effective November 30, 1987 (14:24 Md. R. 2555) **Administrative History:** Annotation: COMAR 10.03.01.07 cited in Attorney General Opinion No. 85-035 (December 31, 1985) **Administrative History:** Regulations .01—.10 adopted effective November 30, 1987 (14:24 Md. R. 2555) **Administrative History:** Regulation .01B amended effective August 17, 1992 (19:16 Md. R. 1474); January 2, 1994 (20:26 Md. R. 2027); January 24, 2000 (27:1 Md. R. 75); February 19, 2001 (28:3 Md. R. 205) **Administrative History:** Regulation .01B amended as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); amended permanently effective December 11, 2003 (30:24 Md. R. 1740) **Administrative History:** Regulation .01B amended effective October 8, 2007 (34:20 Md. R. 1736); June 15, 2009 (36:12 Md. R. 837) **Administrative History:** Regulation .02 amended effective August 25, 1997 (24:17 Md. R. 1214) **Administrative History:** Regulation .02 amended as an emergency provision effective December 18, 2002 (30:1 Md. R. 21) **Administrative History:** Regulation .02 amended effective March 31, 2003 (30:6 Md. R. 420) **Administrative History:** Regulation .02A, E amended effective June 15, 2009 (36:12 Md. R. 837) **Administrative History:** Regulation .02C amended effective September 13, 1993 (20:18 Md. R. 1430) **Administrative History:** Regulation .02D amended effective January 2, 1994 (20:26 Md. R. 2027) **Administrative History:** Regulation .03B amended effective January 2, 1994 (20:26 Md. R. 2027) **Administrative History:** Regulation .05 amended effective February 19, 2001 (28:3 Md. R. 205) **Administrative History:** Regulation .06 amended effective February 19, 2001 (28:3 Md. R. 205) **Administrative History:** Regulation .07 amended effective January 24, 2000 (27:1 Md. R. 75) **Administrative History:** Regulation .07 amended as an emergency provision effective December 18, 2002 (30:1 Md. R. 21) **Administrative History:** Regulation .07 amended as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); amended permanently effective December 11, 2003 (30:24 Md. R. 1740) **Administrative History:** Regulation .07 amended effective October 8, 2007 (34:20 Md. R. 1736) **Administrative History:** Regulation .07A amended effective January 2, 1994 (20:26 Md. R. 2027); August 25, 1997 (24:17 Md. R. 1214) **Administrative History:** Regulation .07B amended effective August 17, 1992 (19:16 Md. R. 1474); January 2, 1994 (20:26 Md. R. 2027); June 15, 2009 (36:12 Md. R. 837); October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .07C amended effective August 17, 1992 (19:16 Md. R. 1474) **Administrative History:** Regulation .07D amended effective February 19, 2001 (28:3 Md. R. 205) **Administrative History:** Regulation .07E amended effective July 9, 1990 (17:13 Md. R. 1610) **Administrative History:** Regulation .07G amended effective January 17, 2005 (32:1 Md. R. 27) **Administrative History:** Regulation .07H amended effective July 9, 1990 (17:13 Md. R. 1610); June 15, 2009 (36:12 Md. R. 837) **Administrative History:** Regulation .07-1 adopted effective March 31, 2003 (30:6 Md. R. 420) **Administrative History:** Regulation .09 amended as an emergency provision effective December 18, 2002 (30:1 Md. R. 21) **Administrative History:** Regulation .09 amended effective March 31, 2003 (30:6 Md. R. 420); June 15, 2009 (36:12 Md. R. 837) **Administrative History:** Regulation .11 adopted as an emergency provision effective January 20, 1989 (16:3 Md. R. 336); adopted permanently effective July 10, 1989 (16:13 Md. R. 1421) **Administrative History:** Regulation .11 repealed effective June 15, 2009 (36:12 Md. R. 837) **Administrative History:** Regulation .12 adopted as an emergency provision effective November 15, 1989 (16:26 Md. R. 2782); adopted permanently effective February 19, 1990 (17:3 Md. R. 297) **Administrative History:** Regulation .12 amended effective February 18, 1991 (18:3 Md. R. 305) **Administrative History:** Regulation .12 amended as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); amended permanently effective December 11, 2003 (30:24 Md. R. 1740) **Administrative History:** Regulation .12B amended effective November 23, 2006 (33:23 Md. R. 1794) **Administrative History:** Regulation .13 adopted effective August 17, 1992 (19:16 Md. R. 1474) **Administrative History:** Regulation .14 adopted as an emergency provision effective September 8, 2003 (30:19 Md. R. 1327); adopted permanently effective December 11, 2003 (30:24 Md. R. 1740) **Administrative History:** Chapter revised effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulation .01B amended effective October 28, 2013 (40:21 Md. R. 1774); June 4, 2018 (45:11 Md. R. 578) **Administrative History:** Regulation .02 amended effective June 4, 2018 (45:11 Md. R. 578) **Administrative History:** Regulation .03 amended effective June 4, 2018 (45:11 Md. R. 578) **Administrative History:** Regulation .03C amended effective January 18, 2016 (43:1 Md. R. 13) **Administrative History:** Regulation .05F amended effective June 4, 2018 (45:11 Md. R. 578) **Administrative History:** Regulation .06 amended effective June 4, 2018 (45:11 Md. R. 578) **Administrative History:** Regulation .08B amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .08I, J amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .10A amended effective June 4, 2018 (45:11 Md. R. 578) **Administrative History:** Regulation .13 amended effective April 15, 2013 (40:7 Md. R. 610) **Administrative History:** Regulation .14A amended effective October 28, 2013 (40:21 Md. R. 1774) **Administrative History:** Regulation .16 adopted effective June 4, 2018 (45:11 Md. R. 578) #### Regulation .01 Definitions. *COMAR 10.03.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Amendment. (a) “Amendment” means an alteration of or change to a vital record based on a court order or documentation specified in this chapter. (b) “Amendment” includes more than one alteration of or change to a vital record, if the alterations or changes are specified in the same court order or the same request supported by documentation specified in this chapter. (2) “Amendment to change a name” means changing or altering any part of the name on a vital record. (3) “Attending clinician” means the physician, nurse midwife, or direct-entry midwife in charge of a birth outside an institution. (4) Authorized Representative. (a) “Authorized representative” means a parent, guardian, or other representative of the subject of the vital record who presents evidence, satisfactory to the Secretary, that that individual is an authorized representative. (b) “Authorized representative” includes but is not limited to: (i) A member of the immediate or surviving family; (ii) A direct ascendant or descendent; (iii) An executor; (iv) An attorney; or (v) After October 1, 1999, a confidential intermediary or the Director of the Social Services Administration of the Department of Human Services. (5) “Common carrier” means a public transportation business, line, or system which moves persons or goods from place to place. For the purpose of these regulations, “common carrier” does not include a funeral director's hearse or vehicle. (6) “Confidential intermediary” means an individual or child placement agency qualified by the Director of the Social Services Administration of the Department of Human Services for the purpose of providing search, contact, and reunion services, as defined at §B(19) of this regulation. (7) “Correction of a name” means altering the spelling of a name to eliminate an obvious misspelling, such as Jaon to Joan, or to eliminate a spelling contrary to the one used by the family, such as Smith to Smythe. (8) “Dead body” means a lifeless human body or parts of a body or its bones from the condition of which it reasonably may be concluded that death has occurred. The term “dead body” does not apply to amputated parts. (9) “Delayed birth registration” means registration of a birth when the child is more than 1 year old. (10) “Department” means the Maryland Department of Health. (11) “Direct-entry midwife” means an individual licensed to practice direct-entry midwifery under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland. (12) “Electronic signature” means an electronic process associated with a record and executed by an individual with the intent to sign the record. (13) “Fetal death” means death before the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy. The death is indicated by the fact that after the separation, the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles. (14) “Filing” means the presentation of a certificate, report, or other record provided for in this subtitle, of a birth, death, fetal death, adoption, marriage, or divorce for registration by the Secretary. (15) “Final disposition” means the burial, interment, cremation, or other disposition of a dead body or fetus. (16) “Human remains” means a dead body or dead fetus for whom a death certificate is required to be filed under this chapter or Health-General Article, Title 4, Subtitle 2, Annotated Code of Maryland. (17) “Institution” means any establishment, public or private: (a) Which provides in-patient medical, surgical, or diagnostic care or treatment; (b) Which provides nursing, custodial, or domiciliary care to two or more unrelated individuals; or (c) To which persons are committed by law. (18) “Live birth” means the complete expulsion or extraction from its mother of a product of human conception, irrespective of the period of gestation, which, after separation, breathes or shows any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscle, whether the umbilical cord has been cut or the placenta is attached. (19) “Mortician” means a funeral director and mortician as defined in Health Occupations Article, Title 7, Annotated Code of Maryland, or other person who is authorized to make final disposition of the human remains. (20) “Nurse midwife” means an individual certified to practice as a nurse midwife under Health Occupations Article, Title 8, Annotated Code of Maryland. (21) “Physician” means a person authorized or licensed to practice medicine in this State pursuant to the provisions of Health Occupations Article, Title 14, Annotated Code of Maryland. (22) “Physician Assistant” means an individual who is licensed under Health Occupations Article, Title 15, Annotated Code of Maryland, to practice medicine with physician supervision. (23) “Registration” means the acceptance by the Secretary and the incorporation in the Department's official records of certificates, reports, or other records provided for in this subtitle, of births, deaths, fetal deaths, adoptions, marriages, or divorces. (24) “Search, contact, and reunion service” means a service to: (a) Locate adopted individuals and biological parents of adopted individuals; (b) Assess the mutual desire for communication or disclosure of information between adopted individuals and biological parents of adopted individuals; and (c) Provide, or provide referral to, counseling for adopted individuals and biological parents of adopted individuals. (25) “Secretary” means the Secretary of Health. (26) “Vital records” means records of birth, death, fetal death, marriage, divorce, adoption, and adjudication of paternity required by law to be registered with the Secretary. #### Regulation .02 Preparation of Certificates. *COMAR 10.03.01.02* A. An individual who prepares a birth, death, or fetal death certificate shall file the record using the electronic vital records registration system maintained by the Department unless otherwise directed by the Secretary. B. Electronic registration may be phased in, as determined by the Secretary, until an electronic vital records registration system is fully implemented. C. An institution, mortician, or attending clinician filing fewer than 10 certificates in a calendar year may not be required to use an electronic vital records registration system. D. An individual who files a record using an electronic vital records registration system shall attest to the record’s accuracy by electronic signature. E. An individual who is required to file records via the electronic vital records registration system: (1) Shall participate in training, as determined by the Secretary, on the proper use of the system; and (2) May be required to successfully complete a certification test on the proper filing of vital records before being granted access to the system. F. A record that is not prepared electronically shall be: (1) Typed or written plainly in black unfading ink; and (2) Signed in black unfading ink to attest to the accuracy of the record. #### Regulation .03 Birth Registration. *COMAR 10.03.01.03* A. Birth Registration Notice. (1) The Secretary may issue a birth registration notice to parents named on the certificate stating that the birth certificate of their child has been registered. (2) The notification in §A(1) of this regulation may not be an official copy of a birth certificate but may be used for proof of age at the discretion of any reviewing agency. B. Name on Certificate. (1) Amendment to Change a Name. (a) The name of an individual born in this State may be changed on that individual's birth certificate once without a court order if, within 12 months of birth, the Department receives: (i) A written request from both parents named on the certificate requesting the change of name; and (ii) An affidavit from both parents sworn before a notary public stating that they are the true parents of the child and are making this request of their own free will. (b) A subsequent change to the name within 12 months of the birth shall require a court order. (c) A change to the name after 12 months of the birth shall require a court order. (2) Correction of Spelling of the Name. (a) A name on a birth certificate may be corrected to its proper spelling at any time upon proof that the name as shown on the birth certificate is incorrect and that the requested spelling is the proper spelling. (b) Documentation required by §B(4) of this regulation shall be necessary proof for the change to be made. (3) Adding a Name. (a) When a person has never had a first and last name placed on a birth record, a name may be added upon proof that the name is the name in use. (b) If a first name has never been placed on a birth record by a parent and the last name is different than the name being used by the subject of the birth record, the Secretary shall replace the last name on the individual's birth certificate when adding the first name, if the individual provides proof that the name is the name used by the individual. (c) Documentation required by §B(4) of this regulation shall be necessary proof for the addition of a name. (4) Documents Needed to Correct or Add a Name. (a) If the subject of the vital record is under 7 years old, one or more of the following documents shall be submitted: (i) A notarized letter from a parent citing the correct name; (ii) A notarized letter from the hospital citing the correct name; (iii) A notarized letter from the attendant at birth citing the correct name; (iv) A notarized physician's office record of the birth citing the correct name. (b) The Department reserves the right to require more than one of the documents listed in §B(4)(a) of this regulation to be submitted as sufficient proof. (c) If the subject of the vital record is 7 years old or older, two or more of the following documents citing the correct name shall be submitted: (i) Baptismal or other church records. To be acceptable, a baptismal record shall be an original certificate or book record made at the time of baptism, or a copy of the certificate or book record executed under church seal by the custodian of the church record, or a notarized statement attesting to the baptism and bearing the signature of the custodian of the church record or records. (ii) Insurance policy. (iii) Hospital or clinic record. (iv) Physician's office record of the birth. (v) Pre-kindergarten record or grade school record. (vi) Family Bible record. The Bible shall be exhibited to the Secretary, State registrar, or local registrar for execution of a certificate of inspection upon a form supplied by the Secretary. (vii) Record of employment. (viii) Record of military service. (ix) Marriage license. (x) Record from federal census. (xi) Birth certificate of a child of the subject of the vital record. (xii) Social Security Administration record of the subject of the vital record's original application for a Social Security Number. (xiii) Other pertinent records which meet the Secretary's approval and corroborate the name of the subject of the vital record. (d) The Department reserves the right to: (i) Require more than two of the documents listed in §B(4)(c) of this regulation to be submitted as sufficient proof to correct or add a name; (ii) Refuse to correct or add a name if the Department finds the documentation submitted unsatisfactory proof of the facts alleged. C. Amending or Correcting Data on Birth Certificate Other than Name. (1) To amend or correct data other than the name on a birth certificate, the following documents and information shall be submitted: (a) For date of birth, time of birth, sex (other than changed by surgery), and place of birth of the subject of the vital record: (i) A letter citing the correct data from the medical records director of the hospital in which the birth occurred; (ii) A letter citing the correct data from the physician, nurse midwife, or attending clinician in attendance at birth; or (iii) A notarized letter citing the correct data from an attendant at birth other than the one set forth in §C(1)(a)(ii) of this regulation. (b) For a parent’s data to be amended or corrected, at least two documents from among those listed below: (i) Parent's birth certificate; (ii) Parent’s baptismal or other church records (refer to specifications under §B(4)(c)(i) of this regulation); (iii) Parent's pre-kindergarten or grade school records; (iv) Other pertinent records which meet the Secretary's approval and corroborate the parent's data. (c) For a parent’s name to be replaced by another individual’s name, the individual requesting the replacement shall obtain an order from a court of competent jurisdiction that orders that: (i) The currently listed parent’s name and any other information about that individual be deleted from the birth certificate; and (ii) A specified individual’s name and other parent’s information as required for a birth certificate be added for the newly named individual. (2) The Department reserves the right to require additional documentation or to refuse to amend or correct information on a birth certificate if it finds the documentation submitted unsatisfactory proof of the facts alleged. D. Method for Amending or Correcting Data on Birth Certificates. (1) Amendments and corrections under this regulation shall be made by: (a) Placing a line through the original data and entering new data in black ink; or (b) Entering the amendment or correction on electronic media. (2) The individual who makes the amendment or correction shall: (a) Record the date the correction or amendment was made; (b) Record the microfilm number if the amendment or correction is made on a paper copy of a record; and (c) Initial the record or provide an electronic signature. E. Certificate for Adjudication of Paternity Record. If the child's name is to be changed, the court order or paternity decree shall state that the name is to be changed and provide the name as it is to appear on the record. F. Audit of Birth Records. (1) All institutions that register births through the electronic vital records registration system shall be: (a) Subject to an audit of the accuracy of the birth records they submit, at an interval determined by the Secretary; and (b) Required to make the medical records available for review by the auditor for comparison to the items captured on the birth record. (2) All attending clinicians in charge of births outside an institution who register those births via the electronic vital records registration system shall be: (a) Subject to an audit of the accuracy of the birth records they submit, at an interval determined by the Secretary; and (b) Required to make the medical records available for review by the auditor for comparison to the items captured on the birth record. #### Regulation .04 Delayed Birth Registration. *COMAR 10.03.01.04* A. Certificate Form. Delayed birth registrations, certificates, and all copies of them shall include, in addition to other items: (1) The word “DELAYED”, prominently printed; (2) The date of filing; and (3) An abstract of the supporting evidence, giving a description of the essential features of the documents and the relevant content of them (any inconsistencies shall be specifically noted). B. Acceptable Records. (1) Documents listed under Regulation .03B(4) of this chapter are the records which may be submitted as proof of the facts alleged. (2) The name, birth date, and birthplace shall be established by three supporting records. (3) The parentage shall be established by at least one record. (4) Supporting records shall be at least 3 years old unless the individual is under 7 years old. C. Examination and Approval of Evidence. (1) The supporting records shall be submitted to the Secretary for approval, provided that bulky records, difficult to transport, may be submitted to a local health officer or a notary public for execution of a certificate of inspection, upon a form to be provided by the Secretary. (2) Supporting evidence may not be regarded as finally approved unless accepted by the Secretary. D. Cancellation of Records. (1) When the Secretary is satisfied that a delayed birth certificate was obtained through fraud or misrepresentation, the Secretary shall send to the person named in the certificate a notice in writing of the intention to cancel the certificate. The notice shall give this person an opportunity to appear and show cause why the certificate should not be cancelled. (2) The notice may be served on the person named in the certificate or, in the case of a minor or incompetent person, to the person's parent or guardian by forwarding the notice by registered mail to the person's last known address on file in the Department. (3) Unless the person named in the certificate, or the parent or guardian, within 30 days after the date of mailing the notice, shows cause satisfactory to the Secretary why the certificate should not be cancelled, the Secretary shall cancel the certificate. #### Regulation .05 Death Registration — Fetal Deaths. *COMAR 10.03.01.05* A. A certificate for fetal death of 20 or more weeks gestation shall be filed regardless of the disposition of the remains. B. If the gestation period is unknown, but the fetus weighs 350 grams or more, a fetal death certificate shall be filed. C. A certificate for fetal death under 20 weeks gestation need not be filed unless the fetus is transported from place of delivery for cremation or private burial. D. A fetal death certificate need not be filed if the gestation period is under 20 weeks and the remains are to be used for scientific or educational purposes by a hospital or other medical facility. E. A dead fetus of any length of gestation may be cremated by a hospital if: (1) The hospital has the facilities; (2) The hospital obtains the written permission from the responsible parent or parents; and (3) The case is not required to be referred to the Medical Examiner. F. When a fetus of 20 or more weeks gestation period is retained or cremated by a hospital, the hospital administrator shall enter his name on the certificate as the funeral director or the person acting as funeral director. #### Regulation .06 Transportation of Human Remains — Burial-Transit Permit. *COMAR 10.03.01.06* A. The mortician who takes custody of human remains shall obtain a burial transit permit before final disposition or removal of the human remains from the State. The form of the burial-transit permit shall be prescribed by the Secretary. B. The burial transit permit shall accompany the human remains to their final destination. C. The individual required to provide the date and place of final disposition on a burial transit permit shall submit the information using the electronic vital records registration system maintained by the Department unless otherwise directed by the Secretary. D. When human remains are to be shipped by common carrier, the casket containing the human remains or the outer case shall be so constructed as to prevent seepage or escape of odors. #### Regulation .07 Disinterment and Reinterment Permits. *COMAR 10.03.01.07* A. When human remains are to be removed from a cemetery or other final resting place and transferred to another cemetery or location, a disinterment and reinterment permit shall be obtained from the local health department in Baltimore City or the county in which the human remains are located or the Maryland Department of Health. The form of this permit shall be prescribed by the Secretary. The Department or local health department may only issue a permit on written authorization from the State's Attorney of the jurisdiction in which the human remains are located or in compliance with a court order. If the human remains are moved to a grave or tomb within the same cemetery for relocation purposes only, a permit is not required. B. When it is required to disinter human remains for an autopsy purpose, even though the human remains are to be reinterred in the same cemetery, an application for a disinterment and reinterment permit shall be made to the local health department or Maryland Department of Health by the Medical Examiner, or by the State's Attorney of Baltimore City or any county of Maryland when acting in the State's Attorney's official capacity in investigating the death. C. When it is proposed to disinter and relocate a number of human remains, only one application shall be made by the mortician. The mortician shall submit with the application an original and copy of a list of the human remains to be disinterred. One disinterment and reinterment permit will be issued. The original of the list shall be attached to the permit and made a part of it, and a copy or electronic file of the list shall be retained by the local health department or Maryland Department of Health. If the names of human remains are not known, this fact shall be indicated on the application. The mortician shall include in the application an identification number, grave space grid number, or other means to identify every one of the human remains to be disinterred and reinterred. D. The application for a disinterment and reinterment permit shall be made on a form prescribed by the Secretary. Upon approval of the completed application, the Secretary, Commissioner of Health of Baltimore City, or the county health officer or their designees, depending on where the human remains are located, shall sign and issue a disinterment and reinterment permit to: (1) An individual qualified in the interment of human remains, such as a mortician or cemeterian; (2) An individual qualified in the funerary rites appropriate to the cultural affiliation of the human remains, such as a minister, priest, or other religious leader; or (3) An anthropologist or archaeologist. E. The disinterment and reinterment permit shall be endorsed by the cemetery authority from which the human remains are disinterred, and also by the cemetery authority in which the human remains are reinterred. The authority of the latter cemetery shall return the permit to the Maryland Department of Health, the Baltimore City Health Department, or the local health department within 10 days after reinterment if reinterment took place in a Maryland county or Baltimore City. If there is no cemetery authority, the mortician shall endorse the permit and return it to the appropriate health department within the time limit specified in this section. F. A disinterred coffin or casket containing human remains shall be so constructed or encased as to prevent seepage or escape of odors. G. Maintenance of Disinterment and Reinterment Permits. (1) The Department and each local health department shall maintain a record of permits issued. (2) A local health department shall provide documentation to the Department relating to a permit issued by the local health department. (3) The Department shall maintain an up-to-date electronic file of all permits issued in the State. H. A disinterment and reinterment permit expires on the 30th day after the date of issuance. I. Except as provided in Health-General Article, §4-215(e)(5), Annotated Code of Maryland, the Department may not disclose or allow public inspection of information in a permit record about the location of the site of a disinterment or reinterment if a local burial sites advisory board or the Director of the Maryland Historical Trust determines that: (1) The site is historic property, as defined in Article 83B, §5-601, Annotated Code of Maryland; and (2) Disclosure would create a substantial risk of harm, theft, or destruction to the site. #### Regulation .08 Inspection of Records and Disclosure of Information. *COMAR 10.03.01.08* A. On request, for birth, death, and marriage records only, the Secretary may disclose data or issue certified copies of vital records, original certificates, or information when satisfied that the applicant has a direct and tangible interest in the content of the record. For divorce records, the Secretary may only verify data or issue information when satisfied that the applicant has a direct and tangible interest in the content of the record. B. Evidence of Direct or Tangible Interest. (1) In the case of birth records, a direct and tangible interest shall be evidenced by a request from: (a) The subject of the vital record; (b) A parent named on the birth certificate; (c) The subject of the vital record's legal guardian; (d) The surviving spouse of the subject of the vital record; (e) An authorized representative of the subject of the vital record; (f) A confidential intermediary authorized by the Director of the Social Services Administration of the Department of Human Services in accordance with Family Law Article, Title 5, Subtitle 3A or 4B, Annotated Code of Maryland; (g) The Director of the Social Services Administration of the Department of Human Services in accordance with Family Law Article, Title 5, Subtitle 3A or 4B, Annotated Code of Maryland; (h) An adoptee 21 years old or older who requests a copy of the adoptee's original certificate of birth, if the adoption was ordered by the court on or after January 1, 2000; or (i) A biological parent of an adoptee 21 years old or older who requests a copy of the adoptee's original certificate of birth, if the adoption was ordered by the court on or after January 1, 2000. (2) In the case of death or fetal death records, a direct and tangible interest shall be evidenced by a request from: (a) Surviving relatives; (b) An authorized representative; (c) A person who is a beneficiary of the deceased; (d) An individual who wishes to establish an estate in the name of the deceased; (e) A person who paid to the deceased while the deceased was alive or who has paid to or is trying to pay to the deceased's beneficiaries insurance benefits, pension benefits, welfare benefits, or other benefits; (f) A person who demonstrates to the Secretary that the individual is trying to carry out a legal duty that was the responsibility of the deceased; (g) A person who presents a subpoena that commands that a copy of the record be produced, if the subpoena is issued by: (i) A court; (ii) An administrative body empowered by statute to issue a subpoena; or (iii) A person empowered by statute to issue a subpoena; (h) A person who is a party or who represents a party in litigation in which there is an issue as to whether the subject of the record is deceased; (i) A person who needs to prove that a beneficiary who is the subject of the record is deceased; (j) A person who needs to prove that the subject of the record is deceased so that a piece of property may be transferred with a clear title; (k) A person who is a creditor of the deceased; (l) A government official who provides documentation satisfactory to the Secretary that a requested death certificate is required in order to carry out the duties or functions of the official’s office; or (m) A hospital official who requests information pertaining to a patient whose cancer diagnosis was reported by the official's hospital to the Maryland Cancer Registry. (3) In the case of marriage records, the direct and tangible interest shall be evidenced by a request from: (a) The married parties; or (b) An authorized representative. (4) In the case of information regarding divorce, a direct and tangible interest shall be evidenced by a request from: (a) The divorced parties; or (b) An authorized representative. C. Birth Records in Cases of Adoption Involving a Confidential Intermediary. (1) A confidential intermediary may apply to the Secretary for: (a) The original certificate of birth and any records that relate to the new certificate of birth of an adopted individual; (b) The new certificate of birth that was substituted for the original certificate of birth of an adopted individual under Health-General Article, §4-211, Annotated Code of Maryland; and (c) The report of the decree or judgment of adoption filed by the clerk of the court under Health-General Article, §4-211, Annotated Code of Maryland. (2) To apply for a copy of a record listed in §C(1) of this regulation, a confidential intermediary shall submit to the Secretary: (a) A written application, as required by the Secretary; and (b) A written statement signed by the Director of Social Services or the Adoption Program Manager of the Department of Human Services and witnessed by a notary public that authorizes the confidential intermediary to obtain a copy of the requested record. (3) If a confidential intermediary complies with the requirements set forth at §C(2) of this regulation, the Secretary shall give a copy of a requested record that is on file with the Secretary to the confidential intermediary. D. Birth Records for Adoptions Finalized on or after January 1, 2000. (1) This section of this regulation: (a) Applies only to adoptions finalized on or after January 1, 2000; and (b) Does not bar: (i) An adoptee or biological parent from applying for search, contact, and reunion services under Family Law Article, Title 5, Subtitle 4B, Annotated Code of Maryland; or (ii) The Director of Social Services of the Maryland Department of Human Services or a confidential intermediary from obtaining a copy of a record under Family Law Article, §5-4B-04(c) or 5-4B-06(b) or (c), Annotated Code of Maryland. (2) An adoptee 21 years old or older may apply to the Secretary for: (a) An uncertified copy of the adoptee's original certificate of birth; (b) A copy of records that relate to the adoptee's new certificate of birth, if any; and (c) A copy of the report of the adoptee's order of adoption filed by the clerk of the court under Health-General Article, §4-211, Annotated Code of Maryland. (3) If an adoptee is 21 years old or older, a biological parent of the adoptee may apply to the Secretary for: (a) An uncertified copy of the adoptee's original certificate of birth; (b) A certified copy of the new certificate of birth, if any, that was substituted, under Health-General Article, §4-211, Annotated Code of Maryland, for the adoptee's original certificate of birth; (c) A copy of all records that relate to the adoptee's new certificate of birth; and (d) A copy of the report of the adoptee's order of adoption filed by the clerk of the court under Health-General Article, §4-211, Annotated Code of Maryland. (4) The Secretary shall inform an applicant applying for a record as set forth in §D of this regulation of the availability of adoption search, contact, and reunion services, as set forth in Family Law Article, Title 5, Subtitle 4B, Annotated Code of Maryland. (5) A person applying for a record under §C(1) and (2) of this regulation shall apply in writing on a form as required by the Secretary and shall submit the form with the individual's signature witnessed by a notary public. (6) The Secretary shall give a copy of the requested record that is on file with the Secretary to the applicant, subject to the restrictions set forth at §E of this regulation. E. Disclosure Vetoes. (1) File with the Director of the Social Services Administration of the Maryland Department of Human Services a disclosure veto to bar disclosure of any information concerning the individual filing the disclosure veto in a record accessible under §D of this regulation; (2) Cancel a disclosure veto at any time; and (3) Refile a disclosure veto at any time. F. Birth certificate information may not be disclosed if the information is to be used for commercial solicitation or private gain. G. Duties of the Secretary of Health. (1) Subject to §G(3) and (4) of this regulation, the Secretary shall give to an applicant who meets the requirements of §D of this regulation a copy of each record that the applicant requests and that the Secretary has on file. (2) When a biological parent applies for a record, the Secretary shall remove from the copy all information as to: (a) The other biological parent, if that parent has filed a disclosure veto in accordance with §E of this regulation; and (b) The adoptee and each adoptive parent, if the adoptee has filed a disclosure veto in accordance with §E of this regulation. (3) When an adoptee applies for a copy of a record, the Secretary shall remove from the copy of the record to be given to the adoptee all information as to the biological parent, if the biological parent has filed a disclosure veto in accordance with §E of this regulation. (4) The Secretary shall give the applicant for a birth record under §§C and D of this regulation: (a) An uncertified copy of the birth certificate, if a birth certificate is requested; and (b) A copy of a notice of the adoption search, contact, and reunion services available under Family Law Article, Title 5, Subtitle 4B, Annotated Code of Maryland. H. Identification of Applicant Data. An applicant who applies for a vital record shall submit: (1) A completed and signed application form, as provided by the Department; and (2) If applying in person, the original of, and if applying by mail, a copy of, proof of identify in the form of: (a) One of the following valid, unexpired, government-issued documents that includes an expiration date: (i) Driver's license; (ii) Nondriver photo identification card; or (iii) Passport; (b) A signed statement that the applicant does not have one of the identification documents set forth in §H(2)(a) of this regulation and, in addition to the signed statement, two of the following documents or copies of the following documents that contain the applicant's name and current address: (i) Utility bill; (ii) Car registration form; (iii) Pay stub; (iv) Bank statement; (v) Income tax return; (vi) Income tax W-2 form; (vii) Lease or rental agreement; or (viii) Letter from a government agency requesting a copy of a vital record; or (c) A signed statement that the applicant does not have the identification documents set forth in §H(2)(a) and (b) of this regulation and, in addition to the signed statement, a document other than the ones set forth in §H(2)(a) and (b) of this regulation that allows the Secretary to corroborate the identity of the applicant. I. Fees Collected by the Department. (1) The Department shall collect a $12 fee when the Department: (a) Issues a certified or abridged copy of a: (i) Death certificate provided concurrently with an initial requested death certificate; (ii) Fetal death certificate; (iii) Marriage certificate; (iv) Verification of divorce certificate; (v) Certificate of foreign birth; or (vi) Certificate of birth resulting in stillbirth; or (b) Issues a report that a search of the fetal death, marriage, or divorce files was made and a requested record is not on file; (c) Makes an amendment to a fetal death or marriage certificate pursuant to a request made more than 1 year after the certificate was registered with the Department; or (d) Processes an adoption, foreign adoption, or legitimation. (2) The Department shall collect a $10 fee when the Department: (a) Issues a certified or abridged copy of: (i) A birth certificate; or (ii) The first copy of a death certificate issued in a single transaction; (b) Issues a report that a search of the birth or death certificate files was made and a requested record is not on file; or (c) Makes an amendment to a birth or death certificate pursuant to a request made more than 1 year after the certificate was registered with the Department. J. Fees Collected by Local Health Departments. (1) A local health department that issues birth certificates shall set and collect a fee for processing and issuing: (a) A birth certificate; or (b) A report that a search of the files was made and the requested record is not on file. (2) From the fee collected for providing a certificate or report under §J(1) of this regulation, the local health department shall transfer $10 to the General Fund of the State. K. Verification Requests. A federal, State, county, municipal government agency, or an accredited private social or welfare agency entitled to access to vital records may be charged a fee for verification of the data in this regulation. L. Certified Copies. Copies of records shall be only from original records on file with the Secretary. When a certified copy is issued, each certification shall contain: (1) A statement that it is a true copy of a record on file with the Secretary; (2) The date issued; (3) The registrar's signature; and (4) The seal of the Secretary. M. Reproduction of Certificates Permitted. A person or agency may photocopy a certified copy of a birth, death, fetal death, or marriage certificate for any nonfraudulent and nondeceptive purpose. N. Statistical or Research Use of Vital Records Data. The Secretary may permit use of data on vital records for statistical or research purposes, subject to conditions the Secretary may impose to ensure that the use of the data is limited to the purposes in this section. #### Regulation .09 Inspection of Records and Disclosure of Information — Maryland Certificate of Foreign Birth. *COMAR 10.03.01.09* A. The Secretary shall prepare and register a Maryland certificate of foreign birth upon a request that the certificate be prepared from the court, an adopting parent, or an adopted individual 18 years old or older, if the adoption took place: (1) Through a court of competent jurisdiction in this State; or (2) Under the laws of a jurisdiction or country other than the United States: (a) By an adopting parent who is a resident of this State; and (b) With an IR-3 visa or IH-3 visa being granted to the adopted individual by the United States Immigration and Naturalization Service under the Immigration and Nationality Act. B. In order for the Secretary to prepare a Maryland certificate of foreign birth pursuant to §A(2) of this regulation, a person shall provide to the Secretary: (1) An application form, as provided by the Department; (2) An official and authenticated copy with valid stamps and seals of the adoption decree from the foreign jurisdiction or country where the adopted individual was adopted; (3) A certified translation of the foreign adoption decree, if the decree is not in English; (4) Proof of the date and place of the adopted individual's birth, as set forth in §C(1) of this regulation; (5) Proof of the IR-3 visa or IH-3 visa status of the adopted individual; and (6) Proof that the adopting parent is a resident of this State, as set forth in §C(2) of this regulation. C. To provide proof of the: (1) Date and place of an adopted individual's birth, a person shall provide to the Secretary: (a) A birth certificate or other birth record for the adopted individual from the jurisdiction or country where the individual was born; and (b) A certified translation of the foreign birth certificate or other birth record, if the foreign birth certificate or other birth record is not in English; and (2) Maryland residency of an adopting parent, an individual shall provide to the Secretary, subject to the restrictions set forth in §D of this regulation, one or more of the following documents relating to the parent: (a) Most recent Maryland tax return; (b) Most recent Maryland property tax bill; (c) Local gas and electric bill that is no more than 4 months old; (d) Valid Maryland driver's license; or (e) Another record that corroborates the Maryland residency. D. The Secretary may: (1) Require more than one of the documents listed in §C(2) of this regulation to be submitted to establish Maryland residency; and (2) Refuse to issue a certificate of foreign birth if the Secretary finds the documentation submitted does not conclusively establish Maryland residency. E. The Secretary shall prepare a certificate of foreign birth with the: (1) Name of the subject of the record being the name of the adopted individual as the individual's name appears or is set in the foreign adoption decree; and (2) Names of the adopting parents recorded as the parents of the adopted individual. F. In order for the Secretary to enter as the subject of a certificate of foreign birth a name different from the name of the adopted individual in the foreign adoption decree, a person shall provide to the Secretary an order from a court of competent jurisdiction that directs the Secretary to prepare the certificate with the different name for the adopted individual. G. The Secretary shall amend the subject's name on a certificate of foreign birth that has already been prepared and registered on receipt of: (1) An order of a court of competent jurisdiction that changes the adopted individual's name; and (2) A request from the adopted individual, the adopting parents, or a guardian or legal representative of the adopted individual that the amendment be made. H. The Secretary shall include on the Maryland certificate of foreign birth: (1) The words “Certificate of Foreign Birth”; (2) The adopted individual's actual country of birth; and (3) A statement that the Maryland certificate of foreign birth is not evidence of United States citizenship for the individual for whom it is issued. #### Regulation .10 Birth Certificate of a Deceased Person. *COMAR 10.03.01.10* A. On presentation of an official death certificate, a birth certificate on a deceased individual may be issued to: (1) A parent; (2) A surviving spouse; (3) A legal guardian; or (4) An authorized representative of the deceased who presents an affidavit attesting to the purpose for obtaining the record. B. The birth record shall be stamped “DECEASED” and the date of death shall be recorded on it. #### Regulation .11 Verification of Data. *COMAR 10.03.01.11* A. Birth, Death, and Marriage Verification. (1) Verification of the facts contained on the vital records in this section may be furnished by: (a) The Secretary or, for births and deaths only, the local health officer of the county of the occurrence of the event, to any of the agencies cited in Regulation .08K of this chapter, in the conduct of their official duties; or (b) The Secretary to a government official who requests the verification in order to carry out the duties or functions of the official's office as specified in Public Law 108-458 or Public Law 109-13. (2) The verifications in §A(1) of this regulation shall be on forms prescribed by the Secretary or on comparable forms which are furnished by the requesting agency or government official and are acceptable to the Secretary. B. Divorce and Annulment of Marriage Verifications. (1) Verifications of the facts in this section shall be made available to persons who are authorized by either subject of the record, including those cited in Regulation .08K of this chapter. (2) The verifications in §B(1) of this regulation shall contain the: (a) Names of the parties involved; (b) Type of divorce action or annulment; (c) County in which the divorce or annulment action took place; (d) Date of the decree; and (e) Signature of the authorized representative of the Secretary. #### Regulation .12 Reports of Divorce and Annulment. *COMAR 10.03.01.12* A. The parties to a divorce or an annulment of marriage action, or their respective attorneys, shall provide the necessary information to the clerk of the appropriate court for the clerk to prepare and forward to the Secretary the required report of divorce or annulment of marriage. B. Divorce or annulment of marriage report records maintained by the Secretary are not official copies of the decrees, and certified copies of the decrees may not be issued by the Secretary. C. A copy of the decrees in §B of this regulation shall be obtained from the appropriate circuit court of the several counties of the State or Baltimore City, depending on where the divorce or annulment action took place. #### Regulation .13 Commemorative Birth Certificate. *COMAR 10.03.01.13* A. The commemorative birth certificate shall: (1) Cost $50 per copy, except under certain circumstances to be determined by the Secretary of Health, and be available for issuance to the subject of the vital record or an authorized representative of the subject of the vital record, or both, or an order of a court of competent jurisdiction; (2) Constitute a certified copy of the original birth record and have the same legal status and be treated with the same protections afforded the photocopied or electronically produced certified copy of the original birth certificate; and (3) Be in a form consistent with the need to protect the integrity of vital records but suitable for display. B. Funds collected for this certificate shall be paid into the Children's Trust Fund established under Health-General Article, §13-2207, Annotated Code of Maryland. Up to $25 of each $50 collected shall go to the Department for production costs. #### Regulation .14 Death Certificate — Amendment. *COMAR 10.03.01.14* A. In order for the name of the deceased, the cause of death and medical certification, the manner of death, the date and time of death, and the place where the death occurred to be amended on a death certificate, the facts necessitating the amendment shall be certified to the Secretary by the physician, physician assistant, or nurse practitioner who filled out and signed the death certificate, or by the medical examiner. B. When a death certificate is filled out and signed by the medical examiner, only the medical examiner may certify to the Secretary the facts necessitating an amendment on the death certificate to the name of the deceased, the cause of death and medical certification, the manner of death, the date and time of death, and the place where the death occurred. #### Regulation .15 Certificate of Birth Resulting in Stillbirth. *COMAR 10.03.01.15* A. The Secretary shall prepare a Maryland certificate of birth resulting in stillbirth upon the request of the parent or parents of a stillborn child. B. In order for the Secretary to prepare a Maryland certificate of birth resulting in stillbirth: (1) A fetal death shall be registered pursuant to Regulation .05A of this chapter; and (2) The parent or parents requesting the certificate of birth resulting in stillbirth shall be named on the registered fetal death certificate. C. Information on Certificate. (1) Except as provided in §C(2) of this regulation, the Secretary shall include on the certificate of birth resulting in stillbirth the following information as it appears on the fetal death certificate: (a) Name of fetus; (b) Date of delivery; (c) Mother's maiden name; (d) Mother's married name; (e) Father's name; and (f) Jurisdiction of delivery, specifying: (i) A county; or (ii) Baltimore City. (2) The Secretary shall include on a certificate of birth resulting in stillbirth the words, “Not a Certificate of Live Birth”. (3) If the parent or parents do not wish to provide a name for the stillborn child, the Secretary may not include on the certificate of birth resulting in stillbirth any name for the stillborn child other than that appearing on the fetal death certificate. (4) If the parent or parents want to add a name to appear on the certificate of birth resulting in stillbirth for the stillborn child that does not appear on the fetal death certificate or amend the name for the stillborn child, the parent or parents shall follow the procedure for additions and amendments to a name on a birth certificate, as set forth in Regulation .03B of this chapter. #### Regulation .16 Births Outside an Institution. *COMAR 10.03.01.16* A. An attending clinician in charge of a birth outside an institution shall: (1) Prepare the forms required by the Secretary to register the birth; and (2) File the forms. B. If a birth occurs outside an institution and an attending clinician is not in charge of the birth, the local health officer or designee of the jurisdiction where the birth occurs shall: (1) Verify the facts regarding the birth by obtaining the documentation required by §D of this regulation; (2) Sign the birth record; and (3) File the birth record with the Secretary. C. If the facts regarding a birth cannot be verified by the local health officer of the jurisdiction where the birth occurs, in order for the Secretary to create a birth record, an individual listed in Health-General Article, §4-208(b), Annotated Code of Maryland, shall obtain an order from a court of competent jurisdiction that: (1) Lists the facts about the birth; and (2) Authorizes the Secretary to create the birth record according to the facts. D. The following documentation shall be required to verify a birth outside an institution when an attending clinician is not in charge of the birth: (1) A valid, unexpired, government-issued identification document for the child’s mother in the form of a: (a) Driver’s license; (b) State-issued photo identification card; (c) Passport; (d) Permanent resident card; (e) Military identification card; or (f) A signed statement the mother does not have any of the identification documents listed in §D(1)(a)—(e) of this regulation and two of the following documents that contain the applicant’s name and current address: (i) Utility bill; (ii) Car registration form; (iii) Pay stub; (iv) Bank statement; (v) Income tax return; (vi) Income tax W-2 form; (vii) Lease or rental agreement; or (viii) Letter from a government agency; (2) Evidence of pregnancy in the form of: (a) A prenatal or postnatal medical record that is consistent with the date of delivery and includes the: (i) Mother’s name, date of birth, and date of health exam; and (ii) Health care provider’s signature, printed name, signature date, and license number; (b) A statement from a physician or certified nurse midwife licensed in the United States, or a direct-entry midwife licensed in Maryland, who has first-hand knowledge of the pregnancy and is willing to attest to the fact of pregnancy; (c) Preregistration with the local health department during pregnancy, including a face-to-face interview and physical examination; (d) Documentation of a home visit by a public health nurse or other health care provider who has first-hand knowledge of the pregnancy; or (e) Other evidence acceptable to the Secretary; (3) Evidence of live birth in the form of: (a) A statement from a physician, certified nurse midwife, or other licensed health care provider who saw or examined the infant within the first 2 weeks of life; (b) An observation of the infant during a home visit by a public health nurse or licensed health care provider during the first 2 weeks of life; or (c) Other evidence acceptable to the Secretary; and (4) Evidence of place of delivery in the State as follows: (a) If the birth occurred in the mother’s place of residence, evidence of place of delivery shall be in the form of: (i) A driver’s license or other State-issued identification document that includes the mother’s current Maryland address; (ii) A rent receipt, mortgage statement, or deed that includes the mother’s name and Maryland address; (iii) A recent pay stub that includes the mother’s name and Maryland address; or (iv) Other evidence acceptable to the Secretary; (b) If the birth occurred outside the mother’s place of residence and the mother is a resident of Maryland, evidence shall be in the form of: (i) An affidavit from the tenant of the premises where the birth occurred stating that the mother was present on those premises at the time of the birth; (ii) Evidence of the affiant’s residence similar to that required in §D(4)(a) of this regulation; and (iii) Evidence of the mother’s residence in the State similar to that required in §D(4)(a) of this regulation; or (c) If the mother is not a resident of Maryland, evidence shall consist of clear and convincing evidence acceptable to the Secretary. ### Chapter 02 — Release of Confidential Information in the Maternal and Child Health Bureau **Authority:** Health-General Article, §§2-104(b), 4-102, 4-301—4-309, and 15-125, Annotated Code of Maryland **Administrative History:** Effective date: July 20, 1950 **Administrative History:** Chapter revised effective December 20, 1993 (20:25 Md. R. 1946) **Administrative History:** Regulation .01 amended effective October 22, 2007 (34:21 Md. R. 1914); March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .02 amended effective October 22, 2007 (34:21 Md. R. 1914) **Administrative History:** Regulation .02B amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .03 amended effective October 22, 2007 (34:21 Md. R. 1914); March 14, 2016 (43:5 Md. R. 385) #### Regulation .01 Confidential Information. *COMAR 10.03.02.01* All information relating to personal facts and circumstances, such as names and addresses, medical examinations, and financial resources, obtained by the State or local staff administering the programs of the Maternal and Child Health Bureau shall be treated as confidential and may not be disclosed without the individual’s consent, except as may be necessary to provide services to individual mothers and children or as otherwise required by law. Information may be disclosed, however, in summary, statistical, or other form which does not identify individuals. #### Regulation .02 Disclosure of Confidential Information. *COMAR 10.03.02.02* All records and information shall be held confidential and may not be disclosed without the individual's consent, except as may be necessary to provide services to the individual mother or child or as otherwise required by law. This means that: A. Confidential information may be released without the patient's or parent's consent to agencies, institutions, or individuals who are authorized to provide maternal and child health services to the mother or child as a part of the program of the Maryland Department of Health. B. Confidential information may be released to other public agencies to the extent that they are authorized to provide services for the health and welfare of the mother or child for whom the patient, or the patient’s parent in the case of a minor, has requested services. In these circumstances, the information may be disclosed only if written assurances are given to the Maternal and Child Health Bureau that: (1) The confidential character of the information will be preserved; (2) The confidential information will be used only for the purpose for which it is disclosed; (3) The purposes for the disclosure are reasonably related to the purposes of the program of the Maryland Department of Health and the functioning of the other agencies; and (4) The standards of protection established by the other agencies to which the confidential information is released are of equal or greater stringency than those established by the Maryland Department of Health itself. #### Regulation .03 Responsibility for Confidential Records and Information. *COMAR 10.03.02.03* The Director of the Maternal and Child Health Bureau, working under the Secretary of Health: A. Is responsible for carrying out this regulation and procedures; B. Shall initiate suitable office practices to assure the protection of confidential records; and C. Is responsible for informing staff employees who have access to confidential records and information. #### Regulation .04 Permissible Disclosure. *COMAR 10.03.02.04* Information may be disclosed in summary, statistical, or other form, which does not make it possible to identify any particular individual. ## Subtitle 04 — Fiscal ### Chapter 01 — Local Health Services Funding **Authority:** Health-General Article, §§2-104(a), 2-105, 2-301—2-305; State Finance and Procurement Article, §12-109; Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1956 **Administrative History:** Chapter revised effective March 20, 1989 (16:5 Md. R. 628) **Administrative History:** Chapter revised effective January 2, 1994 (20:26 Md. R. 2027) **Administrative History:** Regulation .03 amended effective September 23, 1996 (23:19 Md. R. 1376) **Administrative History:** Regulation .04 amended effective September 23, 1996 (23:19 Md. R. 1376) **Administrative History:** Regulation .07D amended effective May 22, 1995 (22:10 Md. R. 708) **Administrative History:** Regulations .01—.09 repealed and new Regulations .01—.06 adopted effective February 26, 2007 (34:4 Md. R. 400) **Administrative History:** Regulation .03B amended effective April 21, 2008 (35:8 Md. R. 804) **Administrative History:** Chapter revised effective November 14, 2011 (38:23 Md. R. 1421) #### Regulation .01 Scope. *COMAR 10.04.01.01* This chapter governs the provision of funding for local health services designated in Health-General Article, §2-304, Annotated Code of Maryland, and, at the discretion of the Secretary, any other State or federal funds that support these services. #### Regulation .02 Definitions. *COMAR 10.04.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Annual formula adjustment” means the amount calculated after applying the percentage change as determined by Health-General Article, §2-302(b)(2), Annotated Code of Maryland. (2) “Department” means the Maryland Department of Health. (3) “Federal non-matching funds” means federal funds made available annually by the State to a subdivision for local health services that do not require local matching funds. (4) “Local health services” means the services specified in Health-General Article, §2-304, Annotated Code of Maryland. (5) “Local matching funds” means the annual funding made available by a subdivision for local health services to qualify for State matching funds, plus any excess amount. (6) “Secretary” means the Secretary of Health or the Secretary's designee. (7) “State funds” means State matching funds plus federal nonmatching funds. (8) “State matching funds” means the general funds made available annually to a subdivision by the State for local health services that require local matching funds. (9) “Subdivision” means a county of this State and Baltimore City. #### Regulation .03 Distribution of State Matching Funds. *COMAR 10.04.01.03* A. For fiscal year 2013 and each subsequent fiscal year, each subdivision shall receive, at a minimum, the amount of State matching funds distributed in fiscal year 2012 for local health services. B. The annual formula adjustment and any other adjustments for local health services shall be allocated to each subdivision based on each subdivision's percentage share of State funds distributed in the previous fiscal year, and to address a substantial change in community health need, if any, as determined in the discretion of the Secretary after consultation with local health officers. #### Regulation .04 Requirement for Local Matching Funds. *COMAR 10.04.01.04* A. As to appropriations referenced in Health-General Article, §2-302, Annotated Code of Maryland, local matching funds shall be required as a condition of any distribution to a subdivision. B. The local match percentage for each subdivision shall equal the percentage required for each subdivision for fiscal year 1996. #### Regulation .05 Submission of Local Health Department Budget for Local Health Services. *COMAR 10.04.01.05* A. An operating budget to implement each local health department's projects for the next fiscal year, funded partially or wholly from funds provided through local health services, shall be prepared in sufficient detail and submitted to the Department for the Secretary to determine the acceptability of the budget. B. The format, content, and submission date of the budget shall be as set forth in the annual local health department budget instructions available on the Department's website or as otherwise determined by the Secretary. C. Each position shall be accounted for in only one project; however, funding for a position may be split among several projects. D. An agreement form signed by the county executive authority and the health officer of the subdivision shall be transmitted to the Department by a date established by the Secretary for the upcoming State fiscal year. The agreement shall include, but is not limited to, the following: (1) A statement showing the amount of the local matching funds, along with any qualifications which cover that funding; (2) A statement indicating whether the subdivision elects to be the paying agent for items other than salaries, or requests that the Department act in that capacity, and, in the event of such a request, the names of the persons upon whose authority commitments and expenditures are authorized; and (3) A statement indicating whether the subdivision wishes to audit those records of the Department pertaining to disbursements made on behalf of the subdivision. E. If the subdivision elects to make an audit as described in §D(3) of this regulation, the audit shall be done within 3 years after the close of the fiscal year that is the subject of the audit. F. On approval by the Secretary, the budget containing State and federal funds and the required local matching funds shall be used as the basis of operation by the health officer for State-supported services. G. Any substantive change in local health projects during the fiscal year is subject to Departmental review and approval, as set forth in the annual local health department budget instructions. H. Cash Transactions. (1) The Department only assumes responsibility in any fiscal year for paying from its funds the State matching funds certified by the Secretary of Health in the agreement for local health services. (2) If a subdivision elects the Department to be its disbursing agent, and the subdivision fails to deposit sufficient funds with the Department to satisfy the subdivision's share of local health services expenditures, the Department may not disburse funds for the subdivision until sufficient funds are deposited by the subdivision to meet the subdivision's financial obligations. (3) If a subdivision elects the Department to be its disbursing agent, the Secretary may charge for the cost of the disbursement-related administrative services rendered by the Division of General Accounting. (4) If the subdivision elects to be the disbursing agent: (a) Disbursements shall be reported monthly to the Division of General Accounting of the Department, in the form and under the conditions as the Department may specify from time to time, in order that these disbursements may be entered on the central accounting records; (b) Funds owed a subdivision shall be paid to the subdivision within 30 days following the end of each quarter, except that funds owed at fiscal year end shall be paid to the subdivision within 30 days following the completion of the annual cost settlement process; and (c) Funds owed the State by a subdivision at fiscal year end shall be paid to the State within 30 days following the completion of the annual cost settlement process. #### Regulation .06 Procedures and Conditions. *COMAR 10.04.01.06* A. Purpose of Expenditure. State funds and local matching funds may only be expended if the activity to be funded is: (1) The responsibility of the local health officer, the Secretary, or the Secretary of the Environment, as established by the general public laws of Maryland; (2) Delegated to the local health officer by the Secretary or the Secretary of the Environment; and (3) With respect to §A(1) and (2) of this regulation, not budgeted for separately in the State budget. B. Procurement. If authorized by the principal executive or legislative authority of the subdivision's government in accordance with local ordinance, a local health department may use either the State procurement system or the procurement system of the subdivision in which the local health department is located. In the absence of such authorization, a local health department shall use the State procurement system in accordance with State Finance and Procurement Article, Annotated Code of Maryland, and COMAR Title 21. C. Expense Accounts. Amounts spent to reimburse personnel for travel expenses in accordance with COMAR 23.02.01 are eligible for State matching funds. D. Employee Fringe Benefits. The employer's payments for Social Security, retirement systems, health insurance, and unemployment insurance are eligible for State matching funds. E. Revenues. Amounts collected in accordance with COMAR 10.02.01 as the result of services rendered as part of local health services shall be treated as a reduction of expenditures for the corresponding project. Amounts collected by subdivisions shall be reported monthly to the Department. F. Interest. A subdivision shall: (1) Deposit the collections and funds allocated to support local health services in a federally insured interest-bearing account when these funds are not required to meet current local health services expenses; and (2) Treat interest income from the local health service revenues which generated the interest as a reduction of expenditures for the local health service which generated the interest. G. Prohibited Expenditures. (1) State matching funds may not be used to support the following categories of expenditures: (a) Hospitalization of clients; (b) Equipment and appliances for individuals; (c) Salary supplements; (d) Utilities; (e) Janitorial expenses; (f) Landscaping; or (g) Other items the Secretary may specify. (2) State matching funds may not participate in the capital costs of or improvements to the physical facilities in which local health department operations are conducted. This regulation applies regardless of the manner in which this cost is defrayed including but not limited to rental, lease, and direct payment of contract for construction or installation. (3) State matching funds may not be used to defray the cost of debt service if the construction or improvement is financed by the creation of a long-term debt. H. Insurance, Repair, and Maintenance of Physical Assets. The cost of insuring, repairing, or maintaining physical assets, the provision of which under this chapter is the responsibility of the subdivision, is not eligible for State matching funds. I. Reimbursement for Injuries. Amounts paid as compensation for injury incurred in the line of duty, and injury other than as a result of malpractice occurring on the premises of a facility of a local health department, as well as the cost of insuring for this liability, are eligible for State matching funds. J. Audits. (1) All Department records of disbursements relating to local health department activities are available for audit by representatives of the county, if they so elect, as provided in Regulation .05D(3) and E of this chapter. (2) All records of disbursements and revenues of the counties relating to local health department activities shall be available for audit by representatives of the Department for at least 5 years following the close of each fiscal year or until audited by the State, whichever comes first. ### Chapter 02 — Establishment and Payment of In-Patient Charges by Recipients of Services and Other Chargeable Persons for the Patient's Care **Authority:** Health-General Article, §§16-201—16-407, Annotated Code of Maryland **Administrative History:** Effective date: September 1, 1976 (3:18 Md. R. 981) **Administrative History:** Regulations .01—.03 amended effective May 5, 1986 (13:9 Md. R. 1028) **Administrative History:** Regulation .02 amended effective June 27, 1988 (15:13 Md. R. 1553) **Administrative History:** Regulation .02S amended effective June 28, 1999 (26:13 Md. R. 1019) **Administrative History:** Regulation .03 amended effective June 27, 1988 (15:13 Md. R. 1553) **Administrative History:** Regulation .03B amended effective October 15, 2001 (28:20 Md. R. 1782) **Administrative History:** Regulation .03G amended effective June 28, 1999 (26:13 Md. R. 1019) **Administrative History:** Regulation .04A amended effective October 15, 2001 (28:20 Md. R. 1782) **Administrative History:** Regulation .04C amended as an emergency provision effective December 2, 1983 (10:26 Md. R. 2336); emergency status expired May 10, 1984 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .04C amended as an emergency provision effective June 6, 1984 (11:13 Md. R. 1169); adopted permanently effective October 8, 1984 (11:20 Md. R. 1742) **Administrative History:** Regulation .04C amended effective June 3, 1985 (12:11 Md. R. 1048); March 23, 1987 (14:6 Md. R. 715); June 27, 1988 (15:13 Md. R. 1553); June 26, 1989 (16:12 Md. R. 1335); September 2, 1991 (18:17 Md. R. 1918); August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .05 repealed effective May 5, 1986 (13:9 Md. R. 1028) **Administrative History:** Annotation: COMAR 10.04.02.03 cited in State of Maryland Central Collection Unit v. Stewart, 292 Md. 255, 438 A.2d 1311 (1981) #### Regulation .01 Scope. *COMAR 10.04.02.01* It is the policy of the Maryland Department of Health to determine the ability of recipients of services, responsible relatives, and other chargeable persons to pay for in-patient or in-residence services to individuals in State-operated facilities. These regulations shall govern the assessment of these charges unless specific charges are established by statutory enactment. #### Regulation .02 Definitions. *COMAR 10.04.02.02* A. “Adjusted gross monthly income” means gross monthly income less allowable deductions as set forth in Regulation .04C(5), of this chapter. B. “Assets” means all accumulated personal wealth over which a person has the authority or power to liquidate his interest, including but not limited to cash savings, savings accounts, certificates of deposit, money market certificates, checking accounts, stocks, bonds, real property, personal property, mortgages, and mutual funds. B-1. “Chargeable person” means: (1) Any responsible relative; and (2) Except for a recipient of services, any other person who is legally responsible in an individual or representative capacity for the care of an individual. C. “Collectively” means pertaining to any combination of one or more responsible relatives. D. “College expenses” means tuition cost for undergraduate studies. E. “Department” means Maryland Department of Health. F. “Dependent” means any person who qualifies as a dependent under the dependency test of the Internal Revenue Service. G. “Gross monthly income” means total annual gross income divided by 12. H. “Income” means a recurrent money benefit from any source. I. “Individually” means pertaining to one sponsor. J. “In-patient” means a person admitted to a State-operated facility. K. “In-patient day.” The number of days of service received by a patient for in-patient services is always in units of full days; a day begins at midnight and ends 24 hours later. The midnight method is to be used for billing days of care of patients. A part of a day, including the day of admission, counts as a full day, however, the day of discharge, the day of death, or a day on which a patient begins a leave of absence is not counted as a day. If admission and discharge or admission and death occur the same day, the day is considered a day of admission and counts as one in-patient day. L. “Monthly rate” means the charge as developed under Regulation .04C(9)(a) of this chapter. M. “Patient” means in-patient. N. “Payroll taxes” means Social Security, federal, State, and local income taxes. O. “Rate” means monthly rate. O-1. “Recipient of services” means an individual who receives care, maintenance, treatment, and support in a facility or program that is operated or funded wholly or partly by the Department. P. “Responsible relative” means the: (1) Spouse of a recipient of services; (2) Parents of a recipient of services who is a minor; and (3) Children of a recipient of services. Q. “Secretary” means Secretary of Health. R. “Sponsor” means responsible relative. S. “State-operated facility” means those hospitals and centers as set forth in Health-General Article, §§7-305, 10-406, and 19-502, Annotated Code of Maryland. T. “Total lifetime hospitalization” means the sum total of all periods of inpatient hospitalization for a recipient of services in any State hospital or facility whether these periods are intermittent or continuous. U. “Treatment” means any process by which professional care or attention is given to a patient in a State-operated facility. #### Regulation .03 Determination of the Ability of a Recipient of Services to Pay. *COMAR 10.04.02.03* A. A recipient of services' primary liability-to-pay in-patient charges established in accordance with COMAR 10.02.01.04 shall be determined by conducting a financial investigation of the individual's income, assets, and expenses. B. Notwithstanding any other provision of law to the contrary, the Department or its designated financial agent may obtain and use financial information and, if and when necessary, a summary of medical and psychological diagnoses regarding a recipient of services. If the obtaining and use of this information is connected to the Department's billing and collection functions under Health-General Article, Title 16, Annotated Code of Maryland: (1) The Department shall obtain a release from the recipient of services or a chargeable person to secure information from a financial institution; (2) The Department shall request either copies of the recipient of services' most recently filed federal and state income tax returns or an affidavit that the recipient of services did not file tax returns for the previous tax year; (3) The failure of the recipient of services to provide the Department with the required documents of financial status, including the most recently filed federal and state income tax returns, may result in the Department charging and the recipient of services being liable for the full per-capita daily charge for services as set forth in COMAR 10.02.01.04; and (4) Except as provided in §C of this regulation, all information obtained by the Department or its designated agent shall be treated as confidential. C. If the financial information is connected to the treatment or care of a recipient of services, the Department or its designated financial agent may disclose the financial information to a designated clinical representative of a facility. D. The Department may set the amount of payments retroactively: (1) For a period of not more than 6 months from the date when the Department sets the amount of payments; and (2) After inquiry by the Department, for a greater period, if the recipient of services, the responsible relatives of the recipient, or any other person, agency, or organization having a summary of financial information or medical or psychological diagnoses about the recipient of services has failed or refused to give that information to the Department when the obtaining and use of this information is connected to the Department's billing and collection functions under this subtitle. E. The Department shall make a claim against all available income or assets, or both, of a recipient of services. F. Health insurance coverage and other third party reimbursements correctly paid, or to be paid, for services provided by the Department shall be considered available for billing purposes. G. For purposes of determining a recipient of services' financial capacity to contribute towards the cost of his or her care, the Department shall consider all of the recipient of services' assets and income to be available for billing purposes subject to certain billing reductions. In recognition of an individual's ongoing financial needs, the Department shall consider a reduction in a recipient of services' billing by permitting the income allowances, asset exemptions, and allowable expenses indicated below. A billing reduction may not be permitted unless and until the recipient of services submits appropriate written documentation demonstrating his or her entitlement to the billing reduction. Permitted billing reductions are as follows: (1) Exempted Assets. The following assets shall be excluded from the Department's ability to pay determinations: (a) A primary residence, occupied by spouse or dependents. (b) A primary residence unoccupied by a spouse or dependents. The assessed value of a recipient of services' primary residence may not be considered for the purpose of establishing charges incurred by the recipient of services during the first 6 months of the individual's hospitalization. An additional 6 months exemption may be allowed if the recipient of services provides written verification from the Department clinician who is primarily responsible for the individual's care which indicates that there is a reasonable clinical likelihood that the individual will be discharged from the facility not later than 12 months following his or her admission to the facility. (c) Household furnishings. (d) One motor vehicle plus other motor vehicles necessary for employment, education, medical care, or maintenance of family life. (e) Liquid assets including but not limited to cash, certificates of deposit, savings and checking accounts, stocks and bonds whose total value does not exceed $2,500. (2) Income allowances. The following sources of income shall be excluded from the Department's ability to pay determinations: (a) Therapeutic work activity income earned in a Department sponsored or approved program which may not exceed $100 per month; (b) If the recipient of services is not involved in a therapeutic work activity program, a monthly personal income allowance of $40. (3) Allowable Expenses. The following documented expenses shall be deducted from the countable gross income in determining a person's ability-to-pay: (a) Reasonable transportation expenses incurred by a recipient of services' relatives and designated visitors during the course of visits to a facility. Mileage allowances shall be calculated in accordance with the prevailing travel allowances permitted for State employees. (b) Health insurance premiums. (c) Life insurance premiums for policies which have a maximum face value which does not exceed $2,500. (d) Reasonable allowances shall be made for necessary and appropriate purchases of clothing and other personal items which may be used by the recipient of services while in a residence or during the course of a clinically sponsored activity. Clinicians responsible for the recipient of services care and treatment shall be consulted to determine the appropriateness of the requested item. (e) Reasonable income allowances reflecting the actual expenses incurred by a recipient of services in maintaining his or her primary residence or apartment provided that when the recipient of services: (i) Is unmarried and has no dependents, the income allowance shall be permitted only for that period of time that the residence is afforded exempt status pursuant to Regulation .03G(1)(b); and (ii) Income constitutes the primary source of financial support for a spouse or other individual claimed as dependents on that individual's federal income tax return, an additional monthly income allowance shall be permitted in an amount equal to the appropriate base monthly deduction as set forth in Regulation .04C(8). H. Monthly Rate. If a combined income is available, the monthly rate charged to the recipient of services and spouse will be computed according to Regulation .04, of this chapter. #### Regulation .04 Determination of the Ability of a Responsible Relative to Pay. *COMAR 10.04.02.04* A. Investigation of Financial Condition. (1) A responsible relative's ability to pay will be determined by an investigation of the financial condition of the person or persons to be held liable for payment for the in-patient treatment rendered at a State-operated facility. The assets, income, and cost of living of responsible relatives will be the subject of the investigation. (2) The Department shall request either copies of the responsible relative's most recently filed federal and state income tax returns or an affidavit that the responsible relative did not file tax returns for the previous tax year. (3) The failure of the responsible relative to provide the Department with the required documents of financial status, including the most recently filed federal and state income tax returns, may result in the Department charging and the responsible relative being liable for the full per-capita daily charge for services as set forth in COMAR 10.02.01.04. B. A maximum monthly charge for which responsible relatives may be held liable, within the scope of these regulations, will be developed by the Department in the following manner: (1) A charge will be developed by multiplying the daily charge set by the Secretary of the Department times 365 and dividing that product by 12. (2) A responsible relative's ability to pay will be measured against the maximum monthly charge. (a) Amounts assessed individually and collectively may not exceed the maximum monthly charge. (b) When a rate is prorated because the total ability to pay of all responsible relatives exceeds the total of the responsible relatives' liability, charges to each responsible relative will be prorated by applying each responsible relatives' ability to pay as a percentage of all responsible relatives' ability to pay. C. Procedure to be Followed for Computation of Monthly Rate. (1) The rate for which a person may be held liable will be determined from that person's adjusted gross monthly income as determined from the financial investigation required by §A, above. (2) The adjusted gross monthly income will be determined by deducting from the gross monthly income all payroll taxes as computed on tax deduction charts developed by the Department and all applicable special or unusual expenses as set forth in these regulations. (3) Self-employment tax paid will be considered in lieu of Social Security tax. (4) Payment into the Federal Retirement Fund will be considered in lieu of Social Security. (5) Special or unusual expenses which may be allowed are: (a) Reasonable child care expenses incurred by the working sponsor; (b) Child support or alimony payments if payments are made to a person who does not qualify as a dependent; (c) College expenses for dependents not to exceed the amount charged for tuition by the University of Maryland at College Park for undergraduate programs; (d) Union dues; (e) Mandatory contributions to retirement plans; and (f) Expenses for special work clothes or special work equipment. (6) Rental Income. One half of gross rental income will be considered as net rental income and will be included in gross monthly income. This may be modified if justifiable reasons are substantiated. (7) Medical Expenses. (a) Paid medical expenses in excess of those used in the cost of living tables in §C(8) may be allowed as an additional deduction. (b) Medical expenses which are covered by medical insurance will not be allowed. (c) Medical insurance premiums will be allowed as medical expenses. (8) Base Monthly Deduction. (a) The Department will develop a base monthly deduction, using the figures established by the Department of Commerce, for the average monthly consumption of a family of four of moderate means in an urban area. The Department will, using 1991 as the base year, adjust annually the base monthly deduction by the percentage by which benefits under Title II of the Social Security Act (42 U.S.C. 401 through 433) are increased by the federal government to reflect changes in the cost of living, as that percentage change is reported in the Federal Register in accordance with 42 U.S.C. 415(a)(1)(D). (b) The base monthly deduction shall be retained in the Office of the Division of Reimbursements and in the Financial Agents' Office located at the Department's in-patient facilities. (9) Monthly Rate. (a) The monthly rate will be determined by subtracting the base monthly deduction from the adjusted gross monthly income. The excess of the adjusted gross monthly income over the base monthly deduction will be the rate of charge for which the responsible relative will be held liable. (b) If the base monthly deduction is equal to or greater than the adjusted gross monthly income, the rate will be zero. (c) Rates will not be set if calculation of a rate results in an amount due of less than $5 per month. (10) Total Lifetime Hospitalization. (a) If a chargeable person has paid for 24 months total lifetime hospitalization of a recipient of services, the liability of that person for the recipient of services after that period may not exceed 15 percent of the charges for services set forth in this section. (b) The sum of any proceeds of applicable insurance, group health plan, or prepaid medical care that the insurer or plan pays because of liability for the payment of or repayment for the cost of care provided to the recipient of services does not count as payments paid by a chargeable person for the purpose of determining a recipient of services, total lifetime hospitalization. ### Chapter 03 — Standards for Audits of Grants and Contracts with Providers and Local Health Departments **Authority:** State Finance and Procurement Article, §7-404, Annotated Code of Maryland **Administrative History:** Effective date: August 12, 1985 (12:16 Md. R. 1605) **Administrative History:** Regulation .04G amended effective March 6, 1989 (16:4 Md. R. 497) **Administrative History:** Regulation .05D amended effective March 6, 1989 (16:4 Md. R. 497) #### Regulation .01 Purpose. *COMAR 10.04.03.01* The purpose of this chapter is to prescribe standards, policies, and procedures for the auditing of grants and contracts of the Maryland Department of Health with vendors, providers of service, and local health departments. #### Regulation .02 Scope. *COMAR 10.04.03.02* A. This chapter shall apply to all contracts and grants made by the Maryland Department of Health with private vendors, grantees, and local health departments for which an audit is provided as described in State Finance and Procurement Article, §7-404, Annotated Code of Maryland. B. The audit shall determine whether funds were spent in accordance with the contract or grant agreement. C. The auditor shall review expenditures and revenues to determine if they are consistent with the approved budget and supported by documentation in accordance with the contract or grant agreement and generally accepted accounting principles. D. The audit shall establish amounts due to or from the State by comparison of budgeted, reported, and audited expenditures net of revenues and funded amounts. E. The audit findings shall be the basis for making a final settlement of the grant or contract. #### Regulation .03 Definitions. *COMAR 10.04.03.03* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Contract” means a formal agreement between the Maryland Department of Health and a provider of services to conduct a program or perform specified services for a consideration. (2) “Expenditures” means disbursement of funds to pay vendors and employees for goods or services provided. (3) “Grant” means an award of financial assistance to an eligible recipient under programs that provide for this assistance based on review and approval of an application setting forth a proposed activity or program. (4) “Grantee” means that institution, public or private agency, corporation, organization, or other legally accountable entity that receives a grant and assumes legal and financial responsibility and accountability both for the awarded funds and for the performance of the grant supported activity. (5) “Revenues” mean monies generated by the program, such as client fees, payments by third parties, contributions and interest earned on deposited grant funds. (6) “Subgrantee” means one of two or more entities whose activities, individually and collectively, are intended to fulfill the purpose of the grant program pursuant to an agreement between the subgrantee and the grantee. #### Regulation .04 Agency Responsibility. *COMAR 10.04.03.04* A. The Secretary of Health shall provide for a periodic examination of the accounts and records of grantees and local health departments receiving funds under contracts and grants with the Department. In addition, periodic audits shall be conducted of the accounts and records of vendors providing purchase of care services for children, juveniles, and adults in non-governmental facilities. The purpose of the audit is to determine if the expenses incurred for which reimbursement was received were in accordance with allowable cost guidelines of the grant award and contractual agreement. B. The Audit Division of the Maryland Department of Health shall be responsible for auditing the accounts and records of all grantees, local health departments, and vendors providing purchase of care services under grants and contracts with the Department, except for those grants and contracts with local governments for which audits have been conducted in accordance with the Single Audit Act of 1984. If these audits are not conducted, or are conducted but do not satisfy the information requirements of the Department, the Audit Division shall be responsible for such further auditing as it deems necessary under the circumstances. C. The audits shall be conducted in accordance with the terms of the grant or contract, or both, and in accordance with allowable cost guidelines of the Maryland Department of Health and its various administrations. D. The Audit Division of the Maryland Department of Health may audit a subgrantee, notwithstanding the responsibility of the primary grantee when it is in the interest of the State to do so. The Department, when it elects to audit a subgrantee, shall inform the primary grantee, in writing, that the primary grantee is absolved of the responsibility stated in Regulation .05C, of this chapter. E. The Audit Division shall conduct an exit conference upon the conclusion of the audit. Before the exit conference the grantee, vendor, or local health department shall be given a draft audit report containing all findings, exceptions, and recommendations of the auditors. In addition, the draft report shall provide detailed information pertaining to amounts due to or from the State resulting from the audit. F. The Audit Division, after consideration and evaluation of additional information and evidence presented subsequent to the promulgation of the draft audit report, shall issue a final audit report. G. The final audit report shall be distributed to the: (1) Grantee, provider, vendor, or local health department; (2) Division of Program Cost and Analysis of the Maryland Department of Health, as applicable; (3) Director of the appropriate program administration of the Maryland Department of Health. H. The Audit Division in the final audit report shall: (1) Address and explain each exception identified by the auditor; (2) Make recommendations for correction of each exception cited in the report; (3) Specify amounts due and to whom; (4) Comment on any other issue warranting attention. I. The audits shall be performed at the intervals and in the manner approved and determined by the Secretary of Health or Director of the appropriate program administration, after consultation with the Chief of the Audit Division. #### Regulation .05 Grantee Responsibility. *COMAR 10.04.03.05* A. The grantee, provider, and local health departments shall provide full disclosure of all accounting, financial, and other records as needed, to the Audit Division during regular business hours of the audited organization. B. The grantee, provider, and local health department shall retain all accounts and records of the grant or contract for a period of 5 years following the close of each fiscal year for audit by the Department. C. Each primary grantee shall be responsible for auditing subgrantees in accordance with the chapter. D. Each grantee shall maintain detailed accounting records as to receipts and expenditures of grant funds pertaining to the direct administration of the program. Each subgrantee is accountable to the primary grantee, who is responsible directly to the Division of Program Cost and Analysis of the Maryland Department of Health. E. Revenues collected as a result of sale of goods and services rendered by persons or facilities receiving grant funds shall be credited to the grant program, and be applied as a reduction of the gross expenditures of the program. These revenues shall include fee collections, third-party payments, and proceeds from sales of goods obtained or manufactured with labor and materials paid for with grant funds. Revenues shall also include interest earned on deposited grant funds and contributions, with the exception of those contributions which are undesignated. F. The grantee, provider, or local health department shall have the right to present additional information and evidence to support its position relative to the audit findings. This information and evidence may be presented at the exit conference or at any time before the issuance of the final audit report. ### Chapter 04 — Human Services Agreements Manual **Authority:** Health-General Article, §2-104(b); State Government Article, §10-110; Annotated Code of Maryland **Administrative History:** Effective date: September 5, 1988 (15:18 Md. R. 2147) #### Regulation .01 Definitions. *COMAR 10.04.04.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Agreement” means a legal document setting forth the rights and responsibilities of the Department and the vendor. (2) “Department” means the Maryland Department of Health. (3) “Human Services” means shelter, support and health or health-related care, including corollary operations necessary to the delivery of that care. (4) “Vendor” means any organization, including a local health department, which delivers human services under a funding arrangement governed by an agreement. #### Regulation .02 Manual. *COMAR 10.04.04.02* A. The Department may enter into an agreement with a vendor to provide human services. B. The agreement shall specify that the Department and the vendor comply with requirements and procedures set forth in the “Human Services Agreements Manual”, which is incorporated by reference. C. The Department shall supply each vendor with a copy of the “Human Services Agreements Manual”. ### Chapter 05 — Community Residential Services *Repealed* **Administrative History:** Effective date: March 14, 1994 (21:5 Md. R. 403) **Administrative History:** Regulations .01—.03 repealed effective March 31, 2014 (41:6 Md. R. 378) ### Chapter 06 — Late Payments *Repealed* **Administrative History:** Effective date: **Administrative History:** Regulations .01—.05 adopted as an emergency provision effective July 1, 1996 (23:14) Md. R. 1006);adopted permanently effective October 7, 1996 (23:20 Md. R. 1422) **Administrative History:** Chapter repealed effective November 3, 1997 (24:22 Md. R. 1551) ## Subtitle 05 — Freestanding Ambulatory Care Facilities ### Chapter 01 — General Requirements **Authority:** Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland **Administrative History:** Effective date: August 23, 1999 (26:17 Md. R. 1322) **Administrative History:** Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 491) **Administrative History:** Regulation .04A, I amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05A amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .08 amended effective April 16, 2012 (39:7 Md. R. 491) **Administrative History:** Regulation .08C amended effective February 27, 2017 (44:4 Md. R. 252) #### Regulation .01 Scope. *COMAR 10.05.01.01* A. This chapter applies to all freestanding ambulatory care facilities. B. An applicant or licensee shall also comply with the regulations of one of the following chapters as appropriate: (1) COMAR 10.05.02; (2) COMAR 10.05.03; (3) COMAR 10.05.04; or (4) COMAR 10.05.05. #### Regulation .02 Definitions. *COMAR 10.05.01.02* A. In this subtitle, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Facility” means a freestanding ambulatory care facility as defined in §B(4) of this regulation. (3) “FDA” means the Food and Drug Administration of the U.S. Department of Health and Human Services. (4) “Freestanding ambulatory care facility” means a: (a) Freestanding surgical facility; (b) Freestanding endoscopy facility; (c) Freestanding facility utilizing major medical equipment; (d) Freestanding birthing center; or (e) Freestanding kidney dialysis center. (5) “Health care practitioner” means a person who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession. (6) “License” means a document issued by the Secretary to a person to operate a freestanding ambulatory care facility. (7) “Physician” means an individual licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland. (8) “Secretary” means the Secretary of Health or the Secretary's designee. (9) "Unexpected adverse outcomes” means unanticipated negative outcomes, related to a patient's medical treatment and not related to the natural course of the patient’s illness or underlying disease condition. #### Regulation .03 License Required. *COMAR 10.05.01.03* A. A person may not establish or operate a freestanding ambulatory care facility without obtaining a license from the Secretary. B. License Period. A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary. C. A license issued under this chapter is not transferable. #### Regulation .04 Licensing Procedure. *COMAR 10.05.01.04* A. A person desiring to operate a facility shall: (1) Be in compliance with all applicable federal, State, and local laws and regulations; (2) File an application on a written or electronic form provided by the Department; (3) Submit documentation that the Maryland Health Resources Planning Commission has determined that the facility either received a certificate of need or is exempt from certificate of need requirements; and (4) Submit a written description of its quality assurance program as required by Regulation .08 of this chapter. B. An officer of a corporation or association shall apply for a license on behalf of the entity. The owner shall apply on behalf of a sole proprietorship. An applicant shall submit the names of the entity's board members, owners, and investors having at least 2 percent ownership. C. An authorized individual of a government unit or agency shall apply for a license on behalf of the government unit or agency. D. For an existing Medicare-certified facility, the Department shall issue a license within 90 days of receiving: (1) A license application; (2) The license fee; and (3) Evidence of compliance with applicable regulations. E. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: (1) Approve the application unconditionally if the applicant complies with all requirements of this chapter; (2) Approve the application conditionally; or (3) Deny the application if the applicant: (a) Has been convicted of: (i) A felony that relates to Medicaid or Medicare, or (ii) A crime involving moral turpitude; or (b) Does not comply with the requirements of this chapter. F. Denial of License for Prior Revocation or Consent to Surrender License. The Secretary may deny a license to: (1) A corporate applicant if the corporate entity has an owner, director, or officer: (a) Whose conduct caused the revocation of a prior license, or (b) Who held the same or similar position in another corporate entity which had its license revoked; (2) An individual applicant: (a) Whose conduct caused the revocation of a prior license, or (b) Who held a position as owner, director, or officer in a corporate entity which had its license revoked; or (3) An individual or corporate applicant that has consented to surrender a license as a result of a license revocation action. G. The Secretary shall also consider the factors identified in Regulation .15D of this chapter when deciding whether to deny a license. H. A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. I. Renewal of License. (1) At least 60 days before a license expires, the licensee shall submit a renewal application to the Secretary on a written or electronic form provided by the Department. (2) The Secretary shall renew the license for an additional 3-year period for a licensee that meets the requirements of this chapter. #### Regulation .05 Inspections by Secretary of Health. *COMAR 10.05.01.05* A. Open for Inspection. A licensed facility or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Department to: (1) Survey freestanding ambulatory care facilities as directed by the Centers for Medicare and Medicaid Services; (2) Verify compliance with licensing regulations; or (3) Investigate complaints. B. Noncompliance. (1) If the Secretary determines that a licensee fails to meet any provision of this chapter, the Secretary shall: (a) Advise the licensee of the exact nature of the violation; and (b) Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action. (2) This section does not preclude the Secretary from imposing any of the sanctions set forth in this chapter. C. Records and Reports. The facility shall make its records and reports available to the Department or its designee for inspection. On the written request of the Department, the facility shall immediately provide photocopies of records and reports, including clinical records of patients. #### Regulation .06 Administration. *COMAR 10.05.01.06* A. The licensee is responsible for the overall conduct of the facility and for compliance with applicable laws and regulations. B. Governing Body. The governing body shall identify the administrator who has been given the authority and responsibility for overall policy and fiscal management of the facility. The governing body shall develop a written organizational plan. C. Administrator. The administrator is responsible for the daily operation of the facility, including but not limited to: (1) Implementing the facility's policies and coordinating the provision of services that the facility provides; (2) Organizing and coordinating the administrative functions of the facility; (3) Establishing procedures for the accountability of those personnel involved in patient care; (4) Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations; (5) Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters; and (6) Participating in the development of organizational and fiscal planning for the facility. D. Policies and Procedures. The administrator, in consultation with the medical director, shall develop and implement policies and procedures governing the operation of the facility which include at a minimum: (1) A description of the scope and delivery of services provided by the facility either directly or through contractual arrangements; (2) A description of the provision of complete and partial charity care for indigent and Medicaid patients to promote access to all services regardless of an individual's ability to pay; (3) Personnel practices; (4) Discharge protocols and aftercare plans; (5) Postoperative recovery, if applicable; (6) The transfer or referral of patients who require services that are not provided by the facility; (7) The transportation of a patient to the nearest appropriate hospital in the event of an emergency situation; (8) Infection control for patients and staff; (9) Pertinent safety practices, including the control of fire and mechanical hazards; and (10) Preventive maintenance for equipment to ensure proper operation and safety. E. The administrator shall ensure that all: (1) Policies and procedures are reviewed by staff at least annually and are revised as necessary; (2) Policies and procedures are available at all times for staff inspection and use; and (3) Appropriate personnel implement all policies and procedures as adopted. #### Regulation .07 Personnel. *COMAR 10.05.01.07* A. The administrator shall ensure that all personnel: (1) Receive orientation and have experience sufficient to demonstrate competency to perform assigned patient care duties; (2) Are licensed or certified by an appropriate occupational licensing board to practice in this State, if required by law; and (3) Perform or delegate duties and responsibilities in accordance with standards of practice as defined by the Health Occupations Article, Annotated Code of Maryland. B. The administrator shall have a sufficient number of qualified professional staff on duty at all times to ensure safe operation and maintenance of the facility. C. The facility shall have job descriptions on file for all personnel. D. The administrator shall ensure that all personnel are free from active reportable airborne communicable disease as evidenced by a physician's or other qualified health care practitioner's statement. #### Regulation .08 Quality Assurance Program. *COMAR 10.05.01.08* A. The administrator shall ensure that the facility develops and maintains a quality assurance program which includes: (1) Monitoring and evaluation of the quality of patient care; (2) Identification, evaluation, and resolution of care problems; and (3) A peer review process. B. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly. C. Peer Review. The administrator shall ensure that the facility establishes a peer review process that includes: (1) A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually; (2) Procedures, approved by a qualified health care practitioner to identify and minimize risks to the patient; and (3) Documentation of each health care practitioner's annual evaluation. D. Practitioner Performance Evaluation in a Facility. (1) The administrator shall ensure that the facility establishes a practitioner performance evaluation process that includes a review of care which shall: (a) Be undertaken for cases chosen at random and for cases with unexpected adverse outcomes; (b) Be based on objective review standards; (c) Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and (d) Be conducted by at least two members of the medical staff who: (i) As appropriate, are of the same specialty as the member of the medical staff under review; and (ii) Have been trained in the freestanding ambulatory care facility’s policies and procedures regarding practitioner performance evaluation. (2) A review of the care provided by a member of the medical staff who is a solo practitioner shall be conducted by an external reviewer. (3) A freestanding ambulatory care facility shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process. E. Equipment Quality Control. (1) The administrator shall ensure that the facility develops a quality control procedure to monitor the safety and performance of all biomedical equipment. (2) In developing its procedures, the administrator shall consider: (a) FDA recommendations; and (b) The equipment manufacturer's recommendations. F. Documentation. (1) At the time of application, the applicant shall submit a written description of the facility's quality assurance program which includes, at a minimum: (a) A description of how the facility will comply with §A of this regulation; and (b) The manner in which information will be collected. (2) The facility shall submit any revisions to its quality assurance program at the time of licensure renewal. G. Quality Assurance Records. The facility shall document the following information for all quality assurance activities: (1) A description of identified problems; (2) Findings; (3) Conclusions; (4) Recommendations; (5) Actions taken; (6) Results; and (7) Follow-up. #### Regulation .09 Medical Records. *COMAR 10.05.01.09* A. The facility shall maintain a complete, comprehensive, and accurate medical record for each patient. B. Each patient's medical record shall include at least the following: (1) Patient identifier; (2) Significant medical history and results of a physical examination; (3) Documentation of care or services provided; (4) Evidence of consent; and (5) Discharge diagnosis. C. The facility shall: (1) Send a copy of the medical record with the patient on referral to another health care provider or on transfer to a hospital; (2) Use the medical record, if appropriate, in instructing the patient and the family; and (3) Comply with all disclosure requirements as set forth in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. #### Regulation .10 Patients' Rights and Responsibilities. *COMAR 10.05.01.10* A. The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients' rights and responsibilities. B. The facility shall make the policies and procedures available to patients, guardians, or other health care decision makers, as defined by Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and the public. C. The policies and procedures shall ensure that: (1) The facility informs patients of services that are available and the charges for services not covered by third-party payors; (2) A physician, dentist, podiatrist, or other qualified health care practitioner informs patients of their medical conditions unless medically contraindicated as documented in their medical records; (3) All patients are afforded an opportunity to participate in planning their medical treatments and to refuse to participate in experimental research; and (4) All patients are ensured confidential treatment of their medical records, and may approve or refuse release of records to any individual outside the facility, except as provided by federal or State law. #### Regulation .11 Physical Environment. *COMAR 10.05.01.11* A. The facility shall meet all federal, State, and local laws, ordinances, and regulations for construction. B. The facility shall meet all safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06. C. The facility shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06. #### Regulation .12 Complaint Investigations. *COMAR 10.05.01.12* A. The Secretary may inspect a facility to investigate and resolve any complaint concerning patient care and safety. B. If the complaint concerns the performance of a health care practitioner or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the health care practitioner to provide services under the Health Occupations Article, Annotated Code of Maryland. #### Regulation .13 Emergency Suspension. *COMAR 10.05.01.13* A. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action. B. The Department shall deliver a written notice to the licensee informing the licensee of the emergency suspension, giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension, and notifying the licensee of the licensee's right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is immediately suspended, the licensee shall: (1) Immediately return the license to the Department; and (2) Stop providing services immediately. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. F. The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .16 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. G. If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. #### Regulation .14 Revocation of License. *COMAR 10.05.01.14* A. Revocation of License. The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested. B. The Secretary may revoke a license if the licensee: (1) Has been convicted of: (a) A felony that relates to Medicaid or Medicare, or (b) A crime involving moral turpitude; or (2) Does not comply with the requirements of this chapter. C. The Secretary shall also consider the factors identified in Regulation .15D of this chapter when deciding whether to revoke a license. D. The Secretary shall notify the licensee in writing of the following: (1) The effective date of the revocation; (2) The reason for the revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the revocation; (4) That the licensee is entitled to a hearing if requested, and to be represented by counsel; (5) That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing; (6) That the revocation shall be stayed if a hearing is requested; and (7) That the licensee is required to surrender the license to the Department if the revocation is upheld. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. #### Regulation .15 Penalties. *COMAR 10.05.01.15* A. Criminal Penalty. A person who violates any provision of this chapter is guilty of a misdemeanor and on conviction is subject to a penalty not exceeding $1,000, or imprisonment not exceeding 1 year, or both. B. Each day that a violation is continued after the first conviction is a separate offense. C. Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter. D. When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors: (1) The number, nature, and seriousness of the violations; (2) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; (4) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (5) Such other factors as justice may require. E. A person aggrieved by the action of the Secretary under §C of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .16 of this chapter. #### Regulation .16 Hearings. *COMAR 10.05.01.16* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Licensing and Certification Administration of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35. ### Chapter 02 — Freestanding Birthing Centers **Authority:** Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland **Administrative History:** Effective date: August 23, 1999 (26:17 Md. R. 1322) **Administrative History:** Chapter revised effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .01B amended effective December 8, 2016 (43:24 Md. R. 1350) **Administrative History:** Regulation .06A amended effective December 8, 2016 (43:24 Md. R. 1350) **Administrative History:** Chapter revised effective October 13, 2025 (52:20 Md. R. 1000) #### Regulation .01 Definitions. *COMAR 10.05.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Nursing. (2) “Certified nurse midwife” has the meaning stated in COMAR 10.27.05.01. (3) Freestanding Birthing Center. (a) “Freestanding birthing center” means a facility that provides nurse midwife services through individuals licensed to practice under Health Occupations Article, Title 8, Subtitle 6, Annotated Code of Maryland. (b) “Freestanding birthing center” does not include: (i) Birthing services that are licensed or accredited as a unit of a hospital; or (ii) The private residence of the patient. (4) “Immediate action” means all actions the freestanding birthing center has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely. (5) Immediate Jeopardy. (a) “Immediate jeopardy” means a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public. (b) “Immediate jeopardy” consists of three components: (i) Noncompliance with this chapter; (ii) Serious injury, harm, or death; and (iii) The need for immediate action. (6) “Informal dispute resolution (IDR)” means an informal process that provides a freestanding birthing center the opportunity to dispute one or more deficiencies cited in a written Statement of Deficiencies issued by the Department or the Department’s designee related to a recent survey. (7) “Licensed certified midwife” has the meaning stated in Health Occupations Article, §8-6D-01, Annotated Code of Maryland. (8) “Licensed direct-entry midwife” has the meaning stated in COMAR 10.64.01.01. (9) “Midwifery” means the antepartum, intrapartum, and postpartum management and care of birthing persons and their newborns. (10) “Need for immediate action” means that immediate corrective action is necessary to remove the jeopardy. (11) “Newborn” means an infant in the first 28 days of life. (12) “Noncompliance” means the freestanding birthing center is non-compliant with one or more licensure requirements of this chapter. (13) Normal Maternity. (a) “Normal maternity” means a low risk, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and generally accepted criteria of maternal and fetal health. (b) “Normal maternity” does not include the use of drugs for induction or augmentation of labor, general and regional anesthesia, vacuum extractors, forceps, recorded electronic fetal monitors, cesarean section, surgical procedures other than episiotomy or perineal repair, intrapartum care provided prior to 36 weeks gestation, or intrapartum care provided after 42 weeks gestation. (14) “Office of Health Care Quality (OHCQ)” means the Office of Healthcare Quality of the Maryland Department of Health. (15) “Plan of Correction” means a written plan submitted by the freestanding birthing center to the OHCQ which documents steps the freestanding birthing center will take to come into compliance with the licensure requirements. (16) “Removal of the immediate jeopardy” means that the freestanding birthing center has implemented the removal plan, and the OHCQ has verified that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment, or death would occur or recur. (17) “Serious injury, harm, or death” means a situation which has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public. (18) “Statement of Deficiencies” means the written notification that the OHCQ issues to the free standing birthing center that contains a listing of deficiencies cited that require correction. #### Regulation .02 Incorporation By Reference. *COMAR 10.05.02.02* In this chapter, the following document is incorporated by reference, National Fire Protection Association (NFPA) 101 Life Safety Code (2018 Edition), which is incorporated by reference in COMAR 29.06.01.06. #### Regulation .03 License Requirements. *COMAR 10.05.02.03* A freestanding birthing center shall only provide normal maternity care and shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter. #### Regulation .04 Licensing Procedure. *COMAR 10.05.02.04* A. An applicant shall submit: (1) An application on a written or electronic form provided by the Department; (2) All other reasonable documents as required by the Department; and (3) A business email address for the applicant or their organization. B. License Application Administratively Closed. (1) An application is not complete until the Department has received the completed license application and all required documents. (2) After 180 calendar days from the date of initial receipt, the Department may deem an incomplete license application inactive and administratively close the application. (3) An applicant whose application is administratively closed may reapply for a license by submitting a new application. C. Voiding of License. (1) Maryland State Department of Assessments and Taxation (SDAT). (a) A freestanding birthing center shall remain in good standing with (SDAT). (b) If the freestanding birthing center fails to return to good standing 60 calendar days after receipt of notification of noncompliance from SDAT or another government agency, the Department may void the freestanding birthing center's license. (2) Ceases the Provision of Services. (a) A license is void if the freestanding birthing center ceases to provide services to patients for a period of 180 consecutive days. (b) The owner shall immediately cease all use of the previously issued freestanding birthing center license when the license is voided. D. Current Business Email Address. A freestanding birthing center is required to maintain a current business email address on file with the OHCQ. #### Regulation .05 Inspection by OHCQ. *COMAR 10.05.02.05* A. A licensee operating a freestanding birthing center shall undergo a routine annual survey. B. A licensee shall allow an on-site survey by the Department at any time during the center’s normal hours of operation to evaluate the center’s compliance with the applicable requirements and standards of this chapter. C. Center employees shall make data and records accessible within a reasonable time during the on-site survey. D. Notice of Deficiencies. (1) If a survey identifies noncompliance with a requirement, the Secretary shall: (a) Issue a written Statement of Deficiencies that cites each deficiency; (b) Require the freestanding birthing center to submit an acceptable Plan of Correction within 10 calendar days of receipt of the Statement of Deficiencies; (c) Notify the freestanding birthing center of any sanctions or that failure to correct the violation may result in sanctions; and (d) Offer the freestanding birthing center the opportunity for IDR. E. Plan of Correction. (1) The freestanding birthing center shall submit a written Plan of Correction to the OHCQ that documents steps the licensee will take to come into compliance, including: (a) How the freestanding birthing center will correct each deficiency; (b) The date by which each deficient practice will be corrected; (c) How the freestanding birthing center will prevent the deficient practice from recurring; and (d) Who will be responsible for ensuring the deficiency will not reoccur. (2) Failure to return an acceptable Plan of Correction within the allotted time frame may result in a sanction. (3) A request for an IDR does not change the freestanding birthing center's requirement to submit a Plan of Correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency. F. Immediate Jeopardy. (1) Declaration of Immediate Jeopardy. (a) When the OHCQ identifies a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public, an immediate jeopardy will be declared. (b) The OHCQ shall provide the freestanding birthing center with a written notice that includes a description of the situation that constitutes an immediate jeopardy. (2) Removal Plan. The freestanding birthing center shall submit a written removal plan to the OHCQ that includes: (a) The immediate action a freestanding birthing center will take to prevent serious harm from occurring or recurring; (b) All actions to remove past, present, and future jeopardy; and (c) The date by which the freestanding birthing center asserts the likelihood for serious harm to any recipient no longer exists. (3) OHCQ's Review of the Removal Plan. (a) The OHCQ shall review the freestanding birthing center's removal plan to determine that the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur. (b) The OHCQ shall verify that the freestanding birthing center has implemented the removal plan. (4) OHCQ's Approval of the Removal Plan. The OHCQ shall approve the removal plan after verifying that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment or death would occur or reoccur. (5) Plan of Correction. If an immediate jeopardy is identified during a survey, the Plan of Correction must completely correct all noncompliance associated with the immediate jeopardy. G. Informal Dispute Resolution (IDR). (1) A freestanding birthing center may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies. (2) The freestanding birthing center shall submit the request for an IDR to the Department within 10 calendar days of receiving the Statement of Deficiencies. (3) The written request for an IDR shall fully describe the disagreement with the Statement of Deficiencies and be accompanied by all evidence for the Department’s consideration. (4) At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing. (5) IDRs are informal in nature and are not attended by legal counsel representing the freestanding birthing center or the Department. (6) The IDR process may not delay the effective date of any enforcement action. (7) In the event a freestanding birthing center requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process. (8) There is no appeal of the Department’s decision in an IDR. #### Regulation .06 Personnel. *COMAR 10.05.02.06* A. Administrator. The licensee shall appoint an administrator of the freestanding birthing center who is responsible for the: (1) Daily administration of the center; and (2) Training and supervision of all nonprofessional staff, unlicensed staff, and volunteers. B. Director of Midwifery Services. The administrator shall appoint a certified nurse midwife or licensed certified midwife as director of midwifery services who is responsible for the employment, training, and supervision of the licensed professional staff C. Clinical Director. (1) The clinical director shall: (a) Be a certified nurse midwife; (b) Be a licensed certified midwife; or (c) Be a physician with: (i) Board certification in a specialty that provides services for pregnant and postpartum patients; or (ii) Appropriate experience in the care of pregnant and postpartum patients; and (d) Be responsible for advising and consulting with the center staff on all matters related to medical management of pregnancy, birth, postpartum, newborn, and gynecologic health care. (2) The same individual may be clinical director and the director of midwifery services. D. Two licensed staff individuals in midwifery, one of whom shall be a certified nurse midwife or licensed certified midwife, shall: (1) Attend each birth; and (2) Be currently certified in: (a) Adult cardiopulmonary resuscitation equivalent to the American Heart Association Class C basic life support; and (b) Neonatal resuscitation by a course endorsed by the American Academy of Pediatrics and the American Heart Association. #### Regulation .07 Clinical Practice Guidelines. *COMAR 10.05.02.07* A. The clinical director and director of midwifery shall develop clinical practice guidelines for the management of routine and emergency care of the patient and the fetus or newborn during pregnancy, birth, and postpartum through discharge, whether through completion of the pregnancy or referral or transfer to other levels of care. B. The clinical practice guidelines shall include, at a minimum, procedures for the: (1) Transfer of patients or newborns for appropriate hospital obstetric and newborn care; (2) Monitoring of fetal heart tones consistent with the current standards of care; and (3) Use of ultrasound imaging that is: (a) Consistent with the current standards of care; and (b) Within the scope of practice for a: (i) Physician; (ii) Certified nurse midwife; or (iii) Licensed certified midwife. C. The administrator shall: (1) Ensure that all clinical practice guidelines are fully implemented by the clinical staff; (2) Periodically review the non-clinical policies and revise them when necessary; and (3) Make the [protocols] clinical practice guidelines available to staff for reference on site at all times. D. A licensed direct-entry midwife, certified nurse midwife, and licensed certified midwife practicing in a birthing center shall remain in compliance with applicable practice guidelines including but not limited to: (1) Health Occupations Article, §8-6C-08, Annotated Code of Maryland; (2) COMAR 10.64.01.10; (3) COMAR 10.27.05.04; and (4) COMAR 10.27.05.01(a)(8). #### Regulation .08 Consultation. *COMAR 10.05.02.08* A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall consult or collaborate with another health care practitioner who has the knowledge, skills, and expertise to manage a clinical issue, as needed or as required in Health Occupations Article, §8-6C-04, Annotated Code of Maryland. #### Regulation .09 Referral System. *COMAR 10.05.02.09* A licensed direct-entry midwife, licensed certified midwife, certified nurse midwife, or physician shall refer and transfer patients with complications beyond their scope of practice to a health care practitioner with the knowledge, skills, and experience to manage the client. #### Regulation .10 Hospitalization. *COMAR 10.05.02.10* A. A freestanding birthing center shall have a written procedure for the transfer of patients to a nearby hospital when care beyond the capabilities of the facility is required. B. Procedures for emergency transfer to a hospital shall include, at minimum: (1) Written clinical practice guidelines related to emergency transfer procedures; (2) A mechanism for notifying the hospital of a pending emergency case; (3) A mechanism for arranging appropriate transportation to the hospital; and (4) Protocols for transmitting a copy of the patient’s medical record to the hospital. C. A freestanding birthing center shall conduct a transfer drill with staff that may be involved in patient transfers at least once a year. #### Regulation .11 Quality Assurance Program. *COMAR 10.05.02.11* A. A freestanding birthing center shall develop and implement a quality assurance program. B. A freestanding birthing center shall collect the following evaluative data in addition to that required in COMAR 10.05.01.08: (1) Number of births; (2) Intrapartum transfer rates and indications for transfer; and (3) Postpartum maternal and neonatal hospital admissions. C. A freestanding birthing center shall conduct a quarterly review of all patients transferred to an emergency department or a hospital. D. Process of Filing a Complaint. The freestanding birthing center shall have a written process that describes how patients are notified of how to file a complaint with the OHCQ and, if applicable, an accreditation organization. #### Regulation .12 Physical Plant. *COMAR 10.05.02.12* A. Bedrooms. A freestanding birthing center shall: (1) Locate bedrooms so as to provide unimpeded, rapid access to an exit of the building where emergency transportation vehicles may be accommodated; (2) Have bedrooms that can accommodate: (a) A double bed or a bed large enough to safely accommodate patient and baby, (b) Birth attendants and support persons, (c) Space for supplies, equipment, and family belongings, and (d) Access to a sink with hot and cold running water equipped with elbow-wrist controls such as are common in home kitchens. B. Toilet Facilities. A freestanding birthing center shall make available separate fixed toilet facilities to the laboring patient and separate toilet facilities for family and staff use. C. Bath Facilities. A freestanding birthing center shall make bath and shower facilities available to the laboring patient and have separate washing facilities available for staff and family. D. Storage, Utility, and Laundry Facilities. A freestanding birthing center shall have facilities that are designed and equipped for washing, sterilizing, storing, and handling equipment, linens, and medical supplies in a manner which ensures separation of clean linen, and sterile supplies and equipment from those that are soiled or contaminated. E. Heating and Ventilation. A freestanding birthing center shall have a safe and adequate source of heat and ventilation capable of maintaining temperature in the birthing unit between 75°F and 85°F. F. Lighting and Power. A freestanding birthing center shall have adequate lighting in the birthing rooms. #### Regulation .13 Fire Safety and Emergency Preparedness. *COMAR 10.05.02.13* A. Fire Safety Protection. (1) Smoke Alarms. A freestanding birthing center shall place smoke alarms on each floor and at points as recommended by the State Fire Marshal or local fire authority. A freestanding birthing center shall have alarms that are audible throughout the center. (2) Fire Extinguishers. A freestanding birthing center shall provide at least one approved fire extinguisher on each floor, including below ground level. (3) Lighting and Power. A freestanding birthing center shall ensure that: (a) Exits are illuminated during time of occupancy; and (b) Emergency lighting is located to provide illumination in event of a power failure. B. Power Outage. A freestanding birthing center shall have: (1) A written plan to address power outages; and (2) Annual staff training relating to power outages. C. Evacuation. (1) A freestanding birthing center shall make written copies of its fire evacuation plan available to all personnel and instruct all personnel in the implementation of the evacuation plan. (2) A freestanding birthing center shall keep all personnel informed of their responsibilities under the plan and conduct a supervised evacuation drill at least once a year. #### Regulation .14 Equipment. *COMAR 10.05.02.14* A. Equipment and furnishings shall be constructed of materials that are easily cleaned and maintained and shall include, at a minimum: (1) A heat source for infant examination or resuscitation; (2) A transfer isolette or demonstrated capability of ready access to a transfer isolette; (3) A sterilizer or demonstration of sterilizing capability; (4) Blood pressure equipment, thermometers, and fetoscope or doptone; (5) Intravenous equipment; (6) Adult and neonatal resuscitation equipment including, but not limited to, oxygen equipment for patient and newborn that is stored in accordance with Standards for Health Care Facilities, NFPA 99; and (7) Instruments for delivery, episiotomy, and repair. B. Laundry. (1) A freestanding birthing center shall provide for the sanitary handling of soiled linens in accordance with 29 CFR §1910.1030, which is incorporated by reference. (2) A freestanding birthing center may have on-site laundry facilities or use a laundry service that is experienced in handling linens for health care facilities. (3) When a freestanding birthing center uses on-site laundry facilities, the center shall disinfect soiled linens by using one of the following methods: (a) Hot water at 160°F; or (b) A low-temperature wash formula which specifies time, temperature, concentration, and pH control in conjunction with chlorine bleach as recommended by the detergent manufacturer for use in a health care setting. (4) A freestanding birthing center shall maintain an adequate linen supply. #### Regulation .15 Health Record. *COMAR 10.05.02.15* A. In addition to meeting the requirements of this regulation, a freestanding birthing center shall comply with the requirements of COMAR 10.05.01.09. B. The health record of each patient shall contain documentation of all services provided while the patient and the fetus or newborn are under the care of the freestanding birthing center, including reports by outside providers who have examined or treated the patient at the request of the center. C. A freestanding birthing center shall: (1) Send a copy of the health record with the patient or newborn, or both, on referral to another health care provider or on transfer to a hospital; and (2) Maintain birth and death certificates on file, as required by Health-General Article, Title 4, Subtitle 2, Annotated Code of Maryland. ### Chapter 03 — Freestanding Major Medical Equipment Facilities **Authority:** Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland **Administrative History:** Effective date: August 23, 1999 (26:17 Md. R. 1322) **Administrative History:** Regulation .04A amended effective February 27, 2017 (44:4 Md. R. 252) #### Regulation .01 Definitions. *COMAR 10.05.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Freestanding Facility Operating Major Medical Equipment. (a) “Freestanding facility operating major medical equipment” means a facility using major medical equipment. (b) “Freestanding facility operating major medical equipment” does not include any freestanding ambulatory care facilities or service owned or operated by a hospital and regulated under COMAR 10.07.01. (2) “JCAHO” means the Joint Commission on Accreditation of Healthcare Organizations, a private organization that creates standards, surveys, and accredits hospitals and health-related facilities. (3) “Major medical equipment” means: (a) All cardiac catheterization equipment necessary to perform heart catheterization; (b) A computed tomography (CT) scanner; (c) A lithotriptor; (d) Radiation therapy equipment, including a linear accelerator; or (e) A magnetic resonance imager (MRI). (4) “Supervisor” means a physician who is licensed by the Board of Physician Quality Assurance and who has expertise in the operation of major medical equipment. #### Regulation .02 License Requirements. *COMAR 10.05.03.02* A. A facility operating major medical equipment shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter. B. An owner of mobile major medical equipment shall obtain a license under this chapter. C. A facility operating major medical equipment that is engaged exclusively in biomedical research is not required to be licensed under this chapter if: (1) Charges for any health care service provided with the equipment will not be paid by any patient or third-party payor; and (2) The capital costs associated with the equipment and any related construction or renovation are not included in patient charges. #### Regulation .03 Licensing Procedure. *COMAR 10.05.03.03* A. A person desiring to establish or operate a facility that operates major medical equipment shall submit an application for licensure. B. The following information for each piece of equipment shall accompany the application: (1) Manufacturer and model of the equipment; (2) Address where the equipment is to be located; and (3) Qualifications of the licensed physician who will be supervising the use of the equipment. C. The applicant or licensee shall submit a nonrefundable fee of $700 with an application for: (1) Initial licensure; or (2) License renewal. #### Regulation .04 Inspections by the Secretary. *COMAR 10.05.03.04* A. The Secretary may verify compliance with licensing requirements through on-site random sample record reviews. B. For the purpose of verifying compliance, the Secretary shall have access to: (1) The facility or office where the equipment is located; (2) Patients' medical records, including image or scan records; (3) Quality assurance records, including peer review documentation; (4) Records documenting in-service training on use of the equipment; (5) Records verifying personnel training; (6) Equipment quality control and inspection records; (7) Radiation safety reports; (8) Records of referrals and evidence of appropriate use of equipment; (9) Policies and procedures that ensure safe operation of equipment; and (10) Qualifications of personnel: (a) Permitted to supervise use of the major medical equipment, (b) Permitted to operate the major medical equipment, and (c) Responsible for maintenance of the major medical equipment. #### Regulation .05 Personnel. *COMAR 10.05.03.05* A. Operators of Magnetic Resonance Imager (MRI) Equipment. Operators of MRI equipment shall demonstrate competency to successfully and safely complete magnetic resonance procedures. B. Operators of Radiation-Producing Equipment. The licensee shall ensure that operators of radiation-producing equipment are qualified in accordance with Health Occupations Article, §§14-306 and 14-606, Annotated Code of Maryland. C. Students and Graduate Technologists. This regulation does not prohibit students or graduate technologists from operating equipment, if the students or technologists are directly monitored by a supervisor. #### Regulation .06 Quality Assurance Program. *COMAR 10.05.03.06* A. A facility operating major medical equipment shall develop and implement: (1) A quality assurance program in compliance with the guidelines outlined in COMAR 10.05.01.08; and (2) Additional quality assurance requirements of this regulation. B. Scope. The quality assurance program shall apply to all personnel supervising or operating major medical equipment. C. Appropriate Use. (1) The administrator shall develop a procedure to monitor referral and appropriate use for each procedure performed using the major medical equipment, ensuring that: (a) Referrals are consistent with the health care practitioner's scope of practice as defined in the Health Occupations Article, Annotated Code of Maryland; (b) The supervisor of major medical equipment is available to a referring health care practitioner to discuss appropriate use; and (c) If the supervisor of major medical equipment questions the appropriateness of a requested procedure, the supervisor shall contact the referring health care practitioner for additional information relating to the appropriateness of using the equipment. (2) When considering appropriate use, the supervisor of major medical equipment shall consider the patient's risks for undergoing specific testing, and the effectiveness of the particular equipment modality to aid in diagnosis. D. The supervisor of the major medical equipment shall monitor the quality assurance program to determine the effectiveness of the delivery of services. #### Regulation .07 Operating Standards for Safety. *COMAR 10.05.03.07* A. A person may not operate major medical equipment unless the operator uses safety measures to protect the patient and the operator in accordance with the requirements of this chapter. B. The administrator shall ensure that all equipment: (1) Is manufactured according to the requirements of 21 CFR 800—1299, which is incorporated by reference; (2) Is appropriately labeled and includes an operating manual; (3) Is considered safe and effective and approved for marketing by receipt of an FDA classification or a letter of approval according to 21 CFR 800—1050.10, which is incorporated by reference; and (4) Meets all applicable standards for equipment adopted by the Division of Radiation Control of the Department of the Environment. C. Safe Operation of Equipment. To ensure safe operation of the equipment, the administrator shall: (1) Develop safety and performance testing procedures; (2) Maintain records of inspection and test results; (3) Develop procedures for identifying equipment malfunctions; (4) Provide instruction and training for equipment operators; (5) Develop policies and procedures that include the following safety rules: (a) Proper safety precautions against fire, explosion, and electrical or mechanical hazards, (b) Guidelines for the management of patients developing emergency situations while undergoing testing, and (c) Safety precautions for equipment that emits radiation and magnetic fields; (6) Develop protocols and procedures to ensure that patients, operators, and individuals are not exposed to unnecessary hazards; and (7) Ensure that operators are familiar with the most current safety procedures. #### Regulation .08 Medical Records. *COMAR 10.05.03.08* A. A facility operating major medical equipment shall comply with all requirements of COMAR 10.05.01.09 and the requirements of this regulation. B. A facility operating major medical equipment shall maintain a medical record for each patient on whom a test is performed and make the information available to the Secretary on request. C. Each patient's medical record shall include the following information: (1) Symptoms exhibited by the patient; (2) Suspected diagnosis before the test or procedure; and (3) Nature of findings. ### Chapter 04 — Freestanding Kidney Dialysis Centers **Authority:** Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland **Administrative History:** Effective date: February 7, 2000 (27:2 Md. R. 144) **Administrative History:** Chapter revised effective November 17, 2008 (35:23 Md. R. 2013) **Administrative History:** Regulation .01B amended effective February 18, 2013 (40:3 Md. R. 217) **Administrative History:** Regulation .06C amended effective February 18, 2013 (40:3 Md. R. 217) **Administrative History:** Regulation .08 amended effective February 18, 2013 (40:3 Md. R. 217) **Administrative History:** Regulation .09A, C amended effective February 18, 2013 (40:3 Md. R. 217) **Administrative History:** Regulation .13 adopted effective February 18, 2013 (40:3 Md. R. 217) **Administrative History:** Regulation .14 adopted effective February 18, 2013 (40:3 Md. R. 217) #### Regulation .01 Definitions. *COMAR 10.05.04.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) "Center administrator" means an individual appointed by the governing body who is responsible for the center's daily operation and the duties set forth in Regulation .04 of this chapter. (2) “Certified nursing assistant—dialysis technician (CNA-DT)” means an individual certified by the Maryland Board of Nursing as a certified nursing assistant—dialysis technician (CNA-DT). (3) “Chief executive officer” means an individual who meets the requirements set forth in 42 CFR §405.2102, as amended, which is incorporated by reference. (3-1) “In-center daytime hemodialysis” means a hemodialysis treatment that: (a) Usually lasts 3 to 5 hours; (b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and (c) Is provided in a kidney dialysis center during daytime hours. (3-2) “In-center nocturnal hemodialysis” means a hemodialysis treatment that: (a) Lasts 6 to 9 hours; (b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and (c) Is provided in a kidney dialysis center. (3-3) “Interdisciplinary team (IDT)” means a multidisciplinary team: (a) Consisting of, at a minimum: (i) The patient or the patient’s designee, if the patient chooses; (ii) A registered nurse; (iii) A physician; (iv) A nurse practitioner or physician assistant treating the patient for ESRD; (v) A social worker; and (vi) A dietitian; and (b) Whose professional members have dialysis experience. (4) Kidney Dialysis Center. (a) “Kidney dialysis center” means a facility that provides hemodialysis or chronic peritoneal dialysis. (b) “Kidney dialysis center” does not include a center or service owned or operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (5) “Patient comprehensive assessment” means an individualized comprehensive assessment that reflects the patient’s psychological, social, medical, dietary, and rehabilitation needs and identifies the care required to meet those needs as well as individualized modifications in the approaches required to meet the patient’s goals. (6) “Patient plan of care” means a written plan that includes all of the care, services, and treatment interventions the interdisciplinary team decides to implement to meet the specific needs of the patient. #### Regulation .02 License Requirements. *COMAR 10.05.04.02* A. A kidney dialysis center shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter. B. An applicant shall obtain Medicare certification as a condition of licensure for a kidney dialysis center. #### Regulation .03 Licensing Procedure. *COMAR 10.05.04.03* A kidney dialysis center shall submit a nonrefundable fee of $700 with an application for initial licensure or $700 with an application for license renewal. #### Regulation .04 Administration. *COMAR 10.05.04.04* A. Governing Body. The governing body shall: (1) Identify the center administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and (2) Develop a written organizational plan. B. Administrator. (1) Qualifications. (a) The kidney dialysis center administrator, if not the chief executive officer, shall at a minimum: (i) Be 21 years old or older; (ii) Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation; (iii) Have at least 1 year of dialysis experience; and (iv) Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through either a criminal history records check or a criminal background check completed within 1 month before employment. (b) The administrator, if not the chief executive officer, shall have knowledge in: (i) Infection control; (ii) Principles of dialysis; (iii) Water treatment; (iv) Reuse; (v) Data collection and quality assurance; (vi) Emergency procedures; (vii) Fiscal operations, including business management and personnel; (viii) Regulations; and (ix) Policies and procedures. (2) Duties. (a) The administrator shall be on site or available on call. (b) The administrator shall have overall responsibility for: (i) Implementing the facility's policies and coordinating the provision of services that the facility provides; (ii) Organizing and coordinating the administrative functions of the facility; (iii) Establishing procedures for the accountability of those personnel involved in patient care; (iv) Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations; (v) Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters; (vi) Participating in the development of organizational and fiscal planning for the facility; (vii) Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and (viii) Informing patients of the availability of emergency services. (3) Waiver of Requirements for Administrator. (a) The Department may grant a kidney dialysis center a waiver, with or without conditions, for a center that operates an administrator-in-training program. (b) A center with an administrator-in-training program shall submit to the Department the: (i) Administrator-in-training curriculum, including course outline and supporting materials; (ii) Center's requirements for individuals who are selected to participate in the administrator-in-training program; and (iii) Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients. (c) In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application and may: (i) Inspect the kidney dialysis center; or (ii) Confer with the governing body. (d) Grant or Denial of Waiver. The Department may grant a waiver request if it determines that: (i) The administrator-in-training program sufficiently meets the requirements of this regulation; and (ii) A waiver will not adversely affect patients. (e) If the Department determines that the conditions of §B(3)(d) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed. (f) Written Decision. (i) The Department shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request. (ii) If the Department grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department. (g) If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed. (h) Any substantive changes to the administrator-in-training program shall be submitted to the Department for prior approval. C. Policies and Procedures. (1) The administrator, in consultation with the governing body, shall develop and implement policies and procedures governing the operation of the facility, which includes at a minimum those items in COMAR 10.05.01.06D and the following: (a) The provision of dialysis and other end-stage renal disease services; (b) The reuse of dialysis supplies including hemodialyzers and blood tubing, if reuse of supplies is practiced by the facility; (c) Implementing and evaluating the patient care plan and the long-term care program for each patient; and (d) Informing patients of the availability of emergency services. (2) The administrator shall ensure that all: (a) Policies and procedures are: (i) Reviewed by staff at least annually and are revised as necessary; and (ii) Available at all times for staff inspection and use; and (b) Appropriate personnel implement all policies and procedures adopted. #### Regulation .05 Quality Assurance Program. *COMAR 10.05.04.05* A. The Administrator shall ensure that the kidney dialysis center has a quality assurance program as required under COMAR 10.05.01.08. B. The quality assurance team shall document information regarding the quality assurance activities in accordance with COMAR 10.05.01.08F and provide a report to the administrator. C. The administrator shall: (1) Review the report specified in §B of this regulation; (2) Implement any necessary corrective actions; and (3) Notify the quality assurance team when corrective actions have been implemented. #### Regulation .06 Personnel. *COMAR 10.05.04.06* A. Medical Director. (1) The medical director shall: (a) Be a nephrologist or other physician with at least 12 months experience in the treatment of patients requiring chronic hemodialysis; (b) Be responsible for the development of patient care policies; and (c) Provide medical guidance in the provision of patient care. (2) If the medical director is not available to provide medical guidance, the administrator shall ensure the availability of an alternate physician with the same qualifications of the medical director as specified in §A(1)(a) of this regulation. B. Charge Nurse. The charge nurse shall be a registered nurse with training in the provision of kidney dialysis services and at least 6 months experience in a dialysis center. C. Dialysis Monitoring. (1) Staffing Ratio. (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients. (b) In-Center Nocturnal Hemodialysis. When in-center nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis shall be: (i) A minimum of one staff member to five participants; and (ii) Sufficient to meet the needs of the patients. (c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (d) The charge nurse may not be included in the staffing ratio except: (i) When there are nine or fewer patients; or (ii) In the event of an emergency. (2) Staffing Exception Reporting. (a) The center shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum: (i) The date and shift of the exception; (ii) A description of the emergency staffing situation; (iii) Actions taken in response; and (iv) Any measures taken to ensure the center's future compliance. (b) The exception reporting protocol shall be included in the center's quality assurance process. (c) The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(1) of this regulation. (3) Monitoring individuals shall be trained in dialysis procedures and may be a: (a) Physician; (b) Physician assistant; (c) Registered nurse; (d) Licensed practical nurse; or (e) Certified nursing assistant — dialysis technician. D. The kidney dialysis center shall also provide dietetic and social work services and consultation by individuals with experience or training in caring for dialysis and transplant patients sufficient to meet the needs of patients. #### Regulation .07 Affiliations. *COMAR 10.05.04.07* In addition to the requirements in 42 CFR §405.2136(e), as amended, which is incorporated by reference, for affiliations, the facility shall provide, make referrals, or have access to a certified home dialysis training program. #### Regulation .08 Patient Long-Term Program. *COMAR 10.05.04.08* A. The facility’s interdisciplinary team shall develop and maintain an individualized interdisciplinary comprehensive assessment for each patient to ensure that each patient receives the appropriate treatment modality, whether dialysis or transplantation. B. Patient Comprehensive Assessment. The patient’s comprehensive assessment shall be developed by a multidisciplinary team. C. The health care team described in §B of this regulation shall review, document, and make appropriate revisions to each patient's comprehensive assessment at least every 12 months or more often as indicated by the patient's response to treatment. D. When a patient is transferred to another kidney dialysis center, the facility shall ensure that a copy of the patient's comprehensive assessment accompanies the patient, or is sent to the new kidney dialysis center within 1 working day after transfer. #### Regulation .09 Patient Care Plan. *COMAR 10.05.04.09* A. Patient Care Plan. A health care team, consisting of at least the physician, nurse practitioner, or physician assistant responsible for the patient's end-stage renal disease care, a nurse responsible for nursing services, a social worker, and a dietitian, shall develop an individualized care plan for each patient. B. The patient or health care decision maker shall be involved in developing the care plan. C. The health care team shall review the patient care plan: (1) At least monthly for a patient whose condition has not stabilized, as determined by a physician's assessment of the patient's laboratory values and physical condition; or (2) Annually for a patient whose condition has stabilized. D. The health care team shall revise the patient care plan as necessary to ensure that it meets the patient's ongoing needs. #### Regulation .10 Dialyzer Reuse. *COMAR 10.05.04.10* A. Patient Information. (1) The kidney dialysis center shall: (a) Provide information to the patient or, if appropriate, the patient's health care decision maker concerning the center's reuse of dialysis supplies, including hemodialyzers and tubing and their suitability for home dialysis; and (b) Obtain the patient's or, if appropriate, the patient's health care decision maker's informed consent regarding the reuse of dialysis supplies. (2) The signed informed consent form shall be maintained in the patient's medical record. B. Standards. If the kidney dialysis center reuses dialysis supplies, the medical director shall: (1) Develop a dialysis reuse policy in accordance with 42 CFR §§405.2139(a), 405.2140(a)(5), (b), and (c), and 405.2150, which are incorporated by reference; and (2) Ensure compliance with the policy. #### Regulation .11 Physical Plant. *COMAR 10.05.04.11* A. Floor Space. (1) The kidney dialysis center shall have usable floor space of at least 80 square feet per patient station. (2) Floor space may include bed or chair space, nursing space, and work area, but excludes storage space. (3) At least 20 square feet of the patient station floor space shall be available on the side of the patient to be occupied by the dialysis assembly. (4) Arrangement of space shall be sufficiently flexible to provide access to any of the patient's four extremities. B. Treatment Area. (1) The treatment area shall be designed and equipped to: (a) Provide privacy and comfort for patients; (b) Facilitate staff monitoring of patients receiving dialysis services; and (c) Provide for the adequate isolation of hepatitis-positive patients. (2) The kidney dialysis center shall have sufficient space for maintenance and storage of equipment and supplies, and for preparing and testing dialyzers. #### Regulation .12 Water Standards. *COMAR 10.05.04.12* A. The kidney dialysis center shall: (1) Comply with 42 CFR §405.2140(a)(5), as amended, which is incorporated by reference; and (2) Assure that the quality of water provided by a municipal water supply meets the federal Environmental Protection Agency standards for dissolved solutes. B. Water Treatment System Safeguards. (1) The kidney dialysis center shall use a water treatment system that offers satisfactory safeguards to patients, including: (a) Appropriate prefiltration for particulate matter; (b) Reverse osmosis monitored by resistivity or conductivity, or an equivalent method, or both; or (c) A mixed-resin bed deionizer with a one megohm monitors light, or an equivalent method. (2) Prefiltration shall be followed by charcoal filtration before reverse osmosis, or deionization, or both. C. The kidney dialysis center shall monitor microbial levels described in §B(1) of this regulation on a monthly basis. D. The kidney dialysis center shall maintain a log of water treatment system function and monitor the values on each occasion the machine is operated. E. The kidney dialysis center shall record in a log system malfunctions or temporary failures to meet standards. F. The kidney dialysis center shall report any system malfunction greater than 1 working day's duration, within 24 hours of discovery of the malfunction, to: (1) The Office of Health Care Quality; (2) The supplier as to the unprotected state of the dialysis facility; and (3) The Commission on Kidney Disease. G. If the kidney dialysis center experiences a water system failure that may threaten patient health or safety, the center shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §405.2140(d), as amended which, is incorporated by reference. #### Regulation .13 In-Center Nocturnal Hemodialysis. *COMAR 10.05.04.13* Before performing in-center nocturnal hemodialysis, the facility’s interdisciplinary team shall: A. Determine the patient’s appropriateness for in-center nocturnal hemodialysis by considering the patient’s: (1) Overall medical condition; (2) Expectations for care; (3) Response to in-center day-time hemodialysis; and (4) Availability of transportation; B. Document the patient’s appropriateness for in-center nocturnal hemodialysis in the patient’s medical record; and C. Obtain an order from a physician, nurse practitioner, or physician assistant for in-center nocturnal hemodialysis. #### Regulation .14 Emergency Management. *COMAR 10.05.04.14* A. A kidney dialysis center shall have an emergency plan. B. An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address: (1) The safe management of individuals who are receiving services at the kidney dialysis center when an emergency occurs; (2) Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis services to the individuals served by the kidney dialysis center; (3) Staff coverage, organization, and assignment of responsibilities; and (4) The continuity of operations, including procedures to secure access to essential goods, equipment, and dialysis services. C. This regulation does not prohibit a kidney dialysis center from applying for and receiving reimbursement: (1) Under any applicable insurance policy; or (2) From any State or federal funds that may be available due to a declared State or federal emergency. D. A kidney dialysis center is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the kidney dialysis center under this regulation. E. For purposes of coordinating local emergency planning efforts, a kidney dialysis center shall provide access to the emergency plan developed under this regulation to local organizations for emergency management. F. A dialysis provider shall provide the Office of Health Care Quality a 24/7 live operational contact phone number. G. Information Regarding the Status of Generators. A kidney dialysis center shall provide one of the following regarding the status of generators: (1) Evidence of an on-site generator; (2) The capacity to hook up a generator; or (3) A copy of the contract with a company who will provide a generator in the event of an emergency, if there is no on-site generator. H. If the center has no plan to use the services of a generator, the center shall provide a copy of the center's emergency plan to the Office of Health Care Quality that will demonstrate that all measures possible are in place to avoid disruption of dialysis services to patients. ### Chapter 05 — Freestanding Ambulatory Surgical Facilities **Authority:** Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland **Administrative History:** Effective date: August 23, 1999 (26:17 Md. R. 1322) **Administrative History:** Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .03 amended effective August 19, 2013 (40:16 Md. R. 1343); December 21, 2015 (42:25 Md. R. 1542) #### Regulation .01 Definitions. *COMAR 10.05.05.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Allied health professional” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services, except those individuals who are licensed to practice medicine, dentistry, or podiatry under the Health Occupations Article, Annotated Code of Maryland. (2) Freestanding Ambulatory Surgical Facility. (a) “Freestanding ambulatory surgical facility” means a facility, service, office facility, or other entity that: (i) Operates exclusively for the purpose of providing surgical services to patients requiring a period of postoperative observation but not requiring hospitalization and in which the expected duration of services would not exceed 24 hours following admission; and (ii) Seeks reimbursement from payors as a freestanding ambulatory surgical facility. (b) “Freestanding ambulatory surgical facility” does not include: (i) The office of one or more health care practitioners seeking only professional reimbursement for the provision of medical services unless the office operates under contract or other agreement with a payor as a freestanding ambulatory surgical facility, regardless of whether it is paid a technical or facility fee, or the office is designated to receive ambulatory surgical referrals in accordance with utilization review or other policies adopted by a payor; (ii) A facility or service owned or operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland; (iii) The office of a health care practitioner with not more than one operating room if the office does not receive a technical or facility fee, and the operating room is used exclusively by the health care practitioner for patients of the health care practitioner; (iv) The office of a group of health care practitioners with not more than one operating room if the office does not receive a technical or facility fee, and the operating room is used exclusively by members of the group practice for patients of the group practice; or (v) An office owned or operated by one or more dentists licensed under the Health Occupations Article, Annotated Code of Maryland, for the sole purpose of practicing dentistry. (3) Freestanding Endoscopy Facility. (a) “Freestanding endoscopy facility” means a facility: (i) For the testing, diagnosis, or treatment of a medical disorder in conjunction with the use of microscopic, endoscopic, or laparoscopic equipment that is inserted in a naturally occurring orifice of the body; and (ii) That seeks reimbursement as a freestanding endoscopy facility from third-party payors. (b) “Freestanding endoscopy facility” does not include: (i) The office of one or more health care practitioners unless the office operates under a contract or other agreement with a payor as a freestanding endoscopy facility, regardless of whether it is paid a technical or facility fee, or the office is designated to receive endoscopic referrals in accordance with utilization review or other policies adopted by a payor; or (ii) A facility or service operated by a hospital and regulated under Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (4) “Payor” means: (a) A health insurer, nonprofit health service plan, or health maintenance organization that holds a certificate of authority to offer health insurance policies or contracts in this State in accordance with Health-General Article, Title 19, Subtitle 7, and the Insurance Article, Annotated Code of Maryland; (b) A third-party administrator or any other entity, under contract with a Maryland business to administer health benefits; or (c) A self-insured group. (5) Surgery. (a) “Surgery” means a procedure conducted for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. (b) “Surgery” includes: (i) The diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transposition of live human tissue which include, lasers, ultrasound, ionizing radiation, scalpels, probes, and needles; (ii) Cut, burned, vaporized, frozen, sutured, probed, or manipulated tissue by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means; or (iii) Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system. (6) “Surgical services” means surgical procedures performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ambulatory surgical center in accordance with approved policies and procedures of the ambulatory surgical center. #### Regulation .02 License Requirements. *COMAR 10.05.05.02* A. A freestanding ambulatory surgical facility shall meet all general licensing requirements for a facility as provided in COMAR 10.05.01 and all requirements of this chapter. B. An applicant shall obtain Medicare certification as a condition of licensure for a freestanding ambulatory surgical facility. #### Regulation .03 Licensing Procedure. *COMAR 10.05.05.03* In addition to meeting all of the requirements of COMAR 10.05.01.03A—C, the applicant shall submit a nonrefundable fee of $1,000 for a 3 year period, with an application for initial licensure, or submit a nonrefundable fee of $1,000 with an application for license renewal for a 3 year period. #### Regulation .04 Administration. *COMAR 10.05.05.04* The medical director shall develop protocols for the management of surgical patients and emergency situations. These protocols shall be available on site at all times for reference. The medical director shall review these protocols annually and make revisions as necessary. #### Regulation .05 Personnel. *COMAR 10.05.05.05* A. Credentialing of Physicians, Dentists, Podiatrists. (1) As part of the formal written appointment process, the administrator, in consultation with the medical director, shall collect, review, and document the following information concerning a physician, dentist, or podiatrist licensed under the Health Occupations Article, Annotated Code of Maryland: (a) The physician's, dentist's, or podiatrist's education; (b) The professional experience of the physician, dentist, or podiatrist, including: (i) Any board certification or specialty training of the physician, dentist, or podiatrist, and (ii) Any post-graduate training; (c) Any license or registration to practice a health occupation ever held by the physician, dentist, or podiatrist, including DEA registration; (d) Whether any license or registration to practice a health occupation ever held by the physician, dentist, or podiatrist has been: (i) Suspended, or (ii) Revoked; (e) Any hospital where the physician, dentist, or podiatrist was appointed or employed during the last 10 years, including: (i) The name of the hospital, (ii) The term of appointment or employment, and (iii) Privileges held and any disciplinary action taken, including suspension, revocation, limitation, or voluntary surrender; (f) The physician's, dentist's, or podiatrist's professional liability insurance for the last 5 years, including: (i) The physician's, dentist's, or podiatrist's present carrier, (ii) The physician's, dentist's, or podiatrist's current limits of coverage, (iii) The physician's, dentist's, or podiatrist's current types of coverage, and (iv) Restrictions on the physician's, dentist's, or podiatrist's coverage; (g) Any claim that has been made against the physician, dentist, or podiatrist in the practice of a health occupation in the last 5 years, and the status of the claim; (h) Any physical or mental condition that currently impairs the physician's, dentist's, or podiatrist's ability to exercise privileges; (i) Any complaint or report, permitted to be disclosed by law, which has been filed with any state licensing or disciplinary body, or comparable body of the armed forces; and (j) Data provided by the National Practitioner Data Bank. (2) The administrator shall consider the delineation of services requested by each physician, dentist, or podiatrist and approve, deny, or modify the request as the administrator deems appropriate. B. For a physician, dentist, or podiatrist who has privileges in a licensed Maryland hospital, the administrator may verify, through the hospital, the credentials described in §A(1) of this regulation. C. The administrator shall establish a procedure for the biennial reappointment of each physician, dentist, or podiatrist. The procedures shall include an evaluation of the following for all physicians, dentists, or podiatrists: (1) An update of the information required in §A(1) of this regulation; and (2) An assessment of the physician's, dentist's, or podiatrist's performance pattern based on an analysis of: (a) Complaints filed with the freestanding ambulatory surgical facility, (b) Malpractice claims filed, (c) Utilization, quality, and risk data, (d) Adherence to policies, bylaws, and procedures, and (e) Physician, dentist, or podiatrist practice patterns as reviewed through the freestanding ambulatory surgical facility's quality assurance program. D. Credentialing of Allied Health Professionals. (1) Direct Hires. (a) The Administrator, in consultation with the medical director, shall collect, review, and verify evidence of the following information for all licensed or certified allied health professionals that are employed by the freestanding ambulatory surgical facility: (i) A current license or certificate to practice in this State; and (ii) Malpractice insurance, if required by the facility. (b) The administrator shall approve the delineation of services to be provided by each allied health professional. (2) Nondirect Hires. When a licensed physician, dentist, or podiatrist uses an allied health practitioner to provide services at the freestanding ambulatory surgical facility, and that person is not employed by the facility, the licensed physician, dentist, or podiatrist who employs the allied health practitioner is responsible for verifying the information required in §D(1) of this regulation. E. Medical Director. (1) The freestanding ambulatory surgical facility shall have a medical director who: (a) Is responsible for the overall medical care that is provided by the facility; and (b) Advises and consults with the staff of the facility on all medical issues relating to services provided by the facility. (2) The medical director shall be a physician, dentist, or podiatrist licensed to practice in the general areas for which the freestanding ambulatory surgical facility provides services. #### Regulation .06 Surgical Services. *COMAR 10.05.05.06* A. Surgical procedures shall be performed in a safe manner by qualified physicians, dentists, or podiatrists who have been granted clinical privileges by the administrator. B. The administrator, in consultation with the medical director, shall develop and implement policies, procedures, and protocols for the provision of surgical services including but not limited to: (1) Personnel; (2) Pre-operative testing and examinations; (3) Surgical procedures; (4) Post-anesthesia care and observation; (5) Discharge planning; (6) Emergency services; (7) Informed consent; and (8) Safety. C. Before conducting a surgical procedure, a physician or other qualified health care practitioner shall conduct a history and physical examination. D. If anything other than an unsupplemented local anesthetic is needed to accomplish a surgical procedure, a qualified anesthetist shall conduct a pre-anesthesia evaluation and document the anesthetic risk to the patient. E. If the assessments required by §§C and D of this regulation are performed before the day of surgery, a qualified health care practitioner shall on the day of surgery reassess and document any change in the patient's clinical status that could have an effect on the surgical procedure to be performed and the anesthesia to be used. F. Discharge. (1) Before discharge from the facility, the anesthetist or, if local anesthesia is administered, the physician, dentist, or podiatrist who performed the surgery shall evaluate each patient for proper anesthesia recovery and document that evaluation. (2) The physician, dentist, podiatrist, or anesthesiologist shall discharge each patient from the facility to a responsible adult, except those patients for whom no supervision is required as determined by the health care practitioner. #### Regulation .07 Anesthesia Services. *COMAR 10.05.05.07* A. Anesthetics shall be administered by health practitioners who are licensed, certified, or otherwise authorized to do so under the Health Occupations Article, Annotated Code of Maryland. B. Anesthetics shall be administered only by a: (1) Qualified anesthesiologist; (2) Physician or dentist qualified to administer anesthesia; (3) Certified registered nurse anesthetist in accordance with Health Occupations Article, §8-205, Annotated Code of Maryland, and COMAR 10.27.06; or (4) Podiatrist in accordance with Health Occupations Article, §16-101, Annotated Code of Maryland. #### Regulation .08 Emergency Services. *COMAR 10.05.05.08* A. Basic Life Support. Licensed personnel employed by the freestanding ambulatory surgical facility shall have certification in basic life support. A licensed staff individual trained in basic life support shall be on duty whenever there is a patient in the facility. B. The licensee shall have: (1) A registered nurse available on site for emergency treatment whenever there is a patient in the freestanding ambulatory surgical facility; (2) At least one physician available by phone 24 hours a day to respond to emergency situations; and (3) Formal arrangements to obtain radiology and laboratory services at all times in case of emergencies. C. The freestanding ambulatory surgical facility shall have at least the following emergency equipment available to the operating rooms: (1) Emergency call system; (2) Oxygen; (3) Mechanical ventilatory assistance including airways, manual breathing bag, and ventilator; (4) Cardiac defibrillator; (5) Cardiac monitoring equipment; (6) Tracheostomy set; (7) Laryngoscopes and endotracheal tubes; (8) Suction equipment; and (9) Emergency medical equipment and supplies specified by the medical staff. #### Regulation .09 Hospitalization. *COMAR 10.05.05.09* A. The freestanding ambulatory surgical facility shall have an effective procedure for the transfer of patients to a hospital when care beyond the capabilities of the facility is required. B. Procedures for emergency transfer to a hospital shall include, at a minimum: (1) Having a written transfer agreement with a local Medicare participating hospital or requiring all physicians, dentists, or podiatrists performing surgery in the freestanding ambulatory surgical facility to have admitting privileges at such a hospital; (2) Having a mechanism for notifying the hospital of a pending emergency case; (3) Having a mechanism for arranging appropriate transportation to the hospital; and (4) The manner in which a facility sends a copy of the patient's medical record to the hospital. #### Regulation .10 Pharmaceutical Services. *COMAR 10.05.05.10* A. The freestanding ambulatory surgical facility shall: (1) Provide drugs and biologicals under the direction of an authorized prescriber; and (2) Develop and implement policies and procedures for pharmacy services in accordance with accepted professional practice. B. Administration of Drugs. (1) Staff shall prepare and administer drugs according to established policies and acceptable standards of practice. (2) Staff shall report adverse reactions to the patient's health care practitioner and document these reactions in the patient's medical record. (3) Only physicians or registered nurses shall administer blood and blood products. (4) Orders given orally for drugs and biologicals shall be followed by a written order which is signed by the authorized prescriber. #### Regulation .11 Laboratory and Radiologic Services. *COMAR 10.05.05.11* A. The administrator shall develop and implement policies and procedures for obtaining routine and emergency laboratory and radiologic services to meet the needs of patients. Policies and procedures shall include: (1) Turn-around time; (2) Review of laboratory reports; and (3) Documentation of laboratory results. B. Laboratory facilities shall be approved under the Clinical Laboratory Improvement Act (CLIA) and be licensed by this State. C. The freestanding ambulatory surgical facility shall include laboratory and radiologic reports in the patient's medical records. #### Regulation .12 Medical Records. *COMAR 10.05.05.12* A. The facility shall comply with COMAR 10.05.01.09 and the requirements of this regulation. B. Each medical record shall include, at a minimum: (1) Preoperative diagnostic studies, entered before surgery, if performed; (2) Findings and techniques of the operation, including a pathologist's report on all tissues removed during surgery, except those tissues exempted by the medical director; (3) Any allergies and abnormal drug reactions; and (4) Entries related to anesthesia administration. #### Regulation .13 Physical Environment. *COMAR 10.05.05.13* A. The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services. B. Each operating room shall be designed and equipped to ensure that surgical procedures conducted can be performed in a manner that ensures the safety of all individuals in the area. C. The facility shall have a separate recovery room and waiting area. ## Subtitle 06 — Diseases ### Chapter 01 — Communicable Diseases and Related Conditions of Public Health Importance **Authority:** Health-General Article, §§2-104(b), 18-102, 18-103, 18-105, 18-201, 18-201.1, 18-202, 18-205,18-208, 18-214.1, 18-307, 18-337, and 24-101—24-110, Annotated Code of Maryland **Administrative History:** Effective date: March 30, 1944 **Administrative History:** Amended April 1, 1966 **Administrative History:** Regulation .55 effective May 15, 1953 **Administrative History:** Regulation .56 effective October 18, 1951 **Administrative History:** Regulation .57 effective April 1, 1966 **Administrative History:** Regulation .58 effective December 20, 1971 **Administrative History:** Regulations .01—.54, .56, and .57 repealed and new Regulations .01—.22 adopted effective December 26, 1980 (7:26 Md. R. 2420) **Administrative History:** Regulations .02A and .03B amended as an emergency provision effective June 21, 1983 (10:14 Md. R. 1257); emergency status expired October 21, 1983 **Administrative History:** Regulations .02A and .03B amended effective October 24, 1983 (10:21 Md. R. 1901) **Administrative History:** Regulation .14D amended as an emergency provision effective March 17, 1981 (8:7 Md. R. 639); emergency status expired August 1, 1981; adopted permanently effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .31 adopted as an emergency provision effective September 2, 1980 (7:20 Md. R. 1872); adopted permanently effective February 6, 1981 (8:3 Md. R. 227) **Administrative History:** Regulations .01—.22, .31, .55, and .58 repealed effective August 7, 1989 (16:15 Md. R. 1650) **Administrative History:** Regulations .01—.17 and .19—.24 adopted effective August 7, 1989 (16:15 Md. R. 1650) **Administrative History:** Regulation .18 adopted effective February 19, 1990 (17:3 Md. R. 297) **Administrative History:** Chapter revised effective July 5, 1993 (20:13 Md. R. 1049) **Administrative History:** Regulation .02 amended and Regulation .06G adopted as an emergency provision effective December 3, 1996 (23:26 Md. R. 1856); amended permanently effective March 24, 1997 (24:6 Md. R. 484) **Administrative History:** Regulation .17D amended as an emergency provision effective December 5, 1997 (24:26 Md. R. 1751); amended permanently effective January 26, 1998 (25:2 Md. R. 76) **Administrative History:** Chapter revised effective January 20, 2003 (30:1 Md. R. 24) **Administrative History:** Regulation .01B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315) **Administrative History:** Regulation .02B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315) **Administrative History:** Regulation .02B amended as an emergency provision effective July 12, 2007 (34:17 Md. R. 1505); emergency status extended at 35:3 Md. R. 285; amended permanently effective January 14, 2008 (35:1 Md. R. 17) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective March 24, 2008 (35:6 Md. R. 698) **Administrative History:** Regulation .03B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315) **Administrative History:** Regulation .03B amended effective March 13, 2006 (33:5 Md. R. 519) **Administrative History:** Regulation .03B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective March 24, 2008 (35:6 Md. R. 698) **Administrative History:** Regulation .04 amended effective March 13, 2006 (33:5 Md. R. 519) **Administrative History:** Regulation .07B amended as an emergency provision effective October 1, 2003 (30:22 Md. R. 1574); amended permanently effective March 1, 2004 (31:4 Md. R. 315) **Administrative History:** Regulation .08-2A, B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective March 24, 2008 (35:6 Md. R. 698) **Administrative History:** Regulation .17-1 adopted as an emergency provision effective July 12, 2007 (34:17 Md. R. 1505); emergency status extended at 35:3 Md. R. 285; adopted permanently effective January 14, 2008 (35:1 Md. R. 17) **Administrative History:** Chapter revised as an emergency provision effective October 1, 2008 (35:22 Md. R. 1946); emergency status extended at 36:10 Md. R. 714; revised permanently effective April 6, 2009 (36:7 Md. R. 522) **Administrative History:** Regulation .01 amended effective April 24, 2017 (44:8 Md. R. 403) **Administrative History:** Regulation .01-1 amended effective April 6, 2009 (36:7 Md. R. 522) **Administrative History:** Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 406); April 24, 2017 (44:8 Md. R. 403) **Administrative History:** Regulation .03C amended effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .17 amended effective April 24, 2017 (44:8 Md. R. 403) **Administrative History:** Regulation .17-1 repealed effective March 28, 2016 (43:6 Md. R. 406) **Administrative History:** Regulation .18 amended effective April 24, 2017 (44:8 Md. R. 403) **Administrative History:** Chapter revised effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .01C amended effective July 12, 2021 (48:14 Md. R. 538) **Administrative History:** Regulation .01-1 amended effective July 12, 2021 (48:14 Md. R. 538) **Administrative History:** Regulation .13D amended effective July 12, 2021 (48:14 Md. R. 538) #### Regulation .01 Scope. *COMAR 10.06.01.01* A. This chapter does not apply to human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) surveillance, reporting, record maintenance, or confidentiality, which are covered by COMAR 10.18.02 and 10.18.03. B. This chapter applies to human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) control. C. This chapter provides regulations for coordinated control efforts for communicable diseases and related conditions by the Department, local health officers, medical laboratory directors, physicians, veterinarians, and other Maryland governmental agencies, as guided by policy statements such as: (1) Recommendations of the Centers for Disease Control and Prevention, such as those of the Advisory Committee on Immunization Practices and the Advisory Council for the Elimination of Tuberculosis; (2) Recommendations of the National Association of State Public Health Veterinarians, including: (a) The Compendium of Animal Rabies Prevention and Control, 2016; (b) The Compendium of Measures to Control Chlamydia psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), 2017; and (c) The Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, 2017. #### Regulation .01-1 Incorporation by Reference. *COMAR 10.06.01.01-1* In this chapter, the following documents are incorporated by reference: A. Control of Communicable Diseases Manual (American Public Health Association, Twentieth Edition, 2015); B. Compendium of Measures to Control Chlamydia psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), 2017 (The Association of Avian Veterinarians, 2017); C. Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, 2017 (The National Association of State Public Health Veterinarians, 2017); and D. Compendium of Animal Rabies Prevention and Control, 2016 (The National Association of State Public Health Veterinarians, 2016). #### Regulation .02 Definitions. *COMAR 10.06.01.02* A. The definitions of terms used in the Control of Communicable Diseases Manual are accepted as official and applicable to the control of diseases within this State under this chapter. B. Terms Defined. (1) Body Fluid. (a) “Body fluid” means an excretion or fluid from a human body that contains visible blood and all other tissues, excretions or fluids including: (i) Visible blood or any body fluid that is visibly contaminated with blood; (ii) Semen or vaginal secretions; (iii) Amniotic, cerebrospinal, pericardial, peritoneal, pleural, or synovial fluids; (iv) Saliva in dental procedures; and (v) All body fluids in situations where it is difficult or impossible to differentiate between body fluids. (b) “Body fluid” does not include stool, nasal secretions, sputum, tears, urine, or vomitus. (2) “Case” means an individual who has laboratory or clinical evidence of being infected by an infectious agent. (3) “Case of a condition” means an individual who suffers from a condition that is not caused by an infectious agent, including, but not limited to: (a) An animal bite; (b) An adverse reaction to pertussis vaccine; (c) Harmful algal bloom related illness; (d) Pesticide related illness; or (e) Ricin toxin poisoning. (4) “Case (or suspected case) of avian psittacosis” means that a bird has: (a) Laboratory evidence of Chlamydophila psittaci infection consisting of: (i) Culture isolation of Chlamydophila psittaci from a clinical specimen; (ii) A positive fluorescent antibody test for Chlamydophila psittaci on a clinical specimen; (iii) A fourfold, or greater, increase in Chlamydophila psittaci antibody in a serologic titer, in two serum specimens obtained at least 2 weeks apart and assayed simultaneously at the same laboratory; or (iv) Identification of Chlamydophila psittaci within macrophages in smears stained with Gimenez or Macchiavellos stain or sections of the bird's tissues; or (b) Clinical evidence of Chlamydophila psittaci infection consisting of an epidemiologic link to an avian case that has laboratory evidence of infection, and has: (i) Exhibited one or more signs of psittacosis; (ii) Died; (iii) Been clinically diagnosed as having psittacosis by a licensed veterinarian; or (iv) Had gross necropsy findings or histopathological evidence consistent with psittacosis as reported by a veterinary pathologist. (5) Child Care Facility. (a) “Child care facility” means a licensed, registered, or unlicensed facility, institution, establishment, or home where children receive care or supervision for which money is paid when the child's parent has given the child's care over to another on a regular basis for some portion of a 24-hour day as a supplement to the parent's primary care of the child. (b) “Child care facility” includes child care center, day care center, nursery, family day care home, and babysitter. (6) Clinical Material. (a) “Clinical material” means: (i) An organism isolated from a clinical specimen; (ii) Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or (iii) If the organism or material described in §B(6)(a)(i) and (ii) of this regulation is not available, material from an individual that has already been obtained by the medical laboratory, in the following order of preference: a patient specimen, microbial genetic material, or other laboratory material. (b) “Clinical material” includes, for Mycobacterium tuberculosis, one culture obtained from the primary isolate on which the diagnosis of tuberculosis was established. (7) “Colonization” means the proliferation of microorganisms on or within one or more body sites without detectable host immune response, cellular damage, or clinical expression. (8) “Commissioner” means the Commissioner of Health of the Baltimore City Health Department. (9) “Department” means the Maryland Department of Health. (10) “Foodborne disease outbreak” means two or more epidemiologically related cases of illness following consumption of a common food item or items, or one case of botulism, cholera, mushroom poisoning, trichinosis, or fish poisoning such as ciguatera poisoning, scombroid poisoning, paralytic shellfish poisoning, and other neurotoxic shellfish poisoning. (11) “Health care provider” includes, but is not limited to: (a) Physicians; (b) Physician assistants; (c) Dentists; (d) Chiropractors; (e) Nurse practitioners; (f) Nurses; (g) Podiatrists; (h) Medical examiners; (i) Hospital administrators; (j) Clinic administrators; (k) Dispensary administrators; (l) Nursing home administrators; and (m) Any other licensed health care providers. (12) Health Care Worker. (a) “Health care worker” means a paid or unpaid individual working in a health care setting who has the potential for exposure to: (i) Infectious materials, including body substances; (ii) Contaminated medical supplies and equipment; (iii) Contaminated environmental surfaces; or (iv) Contaminated air. (b) “Health care worker” includes, but is not limited to: (i) Emergency medical service personnel; (ii) Dental personnel; (iii) Laboratory personnel; (iv) Autopsy personnel; (v) Nurses; (vi) Nursing assistants; (vii) Physicians; (viii) Physician assistants; (ix) Technicians; (x) Therapists; (xi) Pharmacists; (xii) Students and trainees; (xiii) Contractual staff not employed by the health care facility; and (xiv) Individuals not directly involved in patient care but potentially exposed to infectious agents, for example, clerical, dietary, housekeeping, maintenance, and volunteer personnel. (13) “Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City, or the duly designated representative of the health officer, or both. (14) “Infectious” means capable of being transmitted in a manner that can cause a disease or abnormal condition in an individual. (15) “Invasive disease” means a disease in which an organism is detected in a specimen taken from a normally sterile body site. (16) “Normally sterile body site” means a body site except for skin, external ear, oronasopharynx, gastrointestinal tract, urethral meatus, and vagina. (17) “Novel influenza A virus infection” means a human case of infection with an influenza A virus subtype that is suspected to be markedly different from currently circulating human influenza A viruses, including, but not limited to, H2, H5, H7, or H9 subtypes. (18) “Outbreak” means: (a) A foodborne disease outbreak; (b) Three or more cases of a disease or illness that is not a foodborne outbreak and that occurs in individuals who are not living in the same household, but who are epidemiologically linked; (c) An increase in the number of infections in a facility, such as a hospital, long-term care facility, assisted living facility, school, or child care center, over the baseline rate usually found in that facility; (d) A situation designated by the Secretary as an outbreak; or (e) One case of: (i) Anthrax; (ii) Botulism; (iii) Cholera (imported or seafood related); (iv) Ciguatera poisoning; (v) Mushroom poisoning; (vi) Paralytic shellfish poisoning and other neurotoxic shellfish poisoning; (vii) Plague; (viii) Rabies (human); (ix) Smallpox; (x) Scombroid poisoning; or (xi) Trichinosis. (19) Pet Animal. (a) “Pet animal” means a live animal sold or distributed to the public with or without charge for pleasure or companionship and not for utility. (b) “Pet animal” does not include domestic farm animals including, but not limited to: (i) Equids; (ii) Cattle; (iii) Goats; (iv) Sheep; and (v) Swine. (20) Pet Store. (a) “Pet store” means a facility that keeps, cares for, and houses animals classified as pet animals for the purpose of sale or distribution to the public. (b) “Pet store” includes but is not limited to a: (i) Commercial facility; (ii) Feed store; or (iii) Department store. (21) “Physician” means an individual licensed to practice osteopathy or medicine by the State, or the physician's designee working under the supervision of the physician. (22) “Reptile” means a cold blooded, air breathing vertebrate of the class Reptilia. (23) “Secretary” means the Secretary of Health or the Secretary's designee. (24) “Sell” means to sell, hold for sale, or offer for commercial or public distribution, a pet animal. (25) “Seller” means a person who sells, holds for sale, or offers for commercial or public distribution, a pet animal. (26) “Sexually transmitted infection” means an infection which may be spread by sexual intercourse, including oral, anal, or vaginal sexual contact with an infected individual. (27) Skin-Penetrating Body Adornment Procedure. (a) “Skin-penetrating body adornment procedure” means a process that involves piercing or entering the skin or the mucous membrane of an individual for the purpose of inserting pigmented patterns, jewelry, or other forms of body decoration. (b) “Skin-penetrating body adornment procedure” includes body-piercing and tattooing. (c) “Skin-penetrating body adornment procedure” does not include piercing of an earlobe using a properly disinfected ear-piercing gun and single-use sterile studs and clutches. (28) Standard Precautions. (a) “Standard precautions” means a group of infection prevention practices that apply to all patients, regardless of suspected or confirmed diagnosis or presumed infection status, given that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents. (b) “Standard precautions” includes: (i) Hand hygiene and use of gloves, gown, mask, eye protection, or face shield depending on anticipated exposure; and (ii) Handling equipment or items in the patient environment likely to have been contaminated with infectious fluids in a manner to prevent transmission of infectious agents. (29) “Turtle” means an animal commonly known as a turtle, tortoise, or terrapin. #### Regulation .03 Reportable Diseases, Conditions, Outbreaks, and Unusual Manifestations; Submitting Clinical Materials. *COMAR 10.06.01.03* A. A person, as set forth in Regulation .04 of this chapter, shall report the diseases or conditions listed in §C of this regulation, or any other condition as requested by the Secretary. B. Upon a positive laboratory finding for a disease or condition listed in §C of this regulation, or upon request of the Secretary, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall: (1) Submit clinical material to the Department's public health laboratory; and (2) Include information about the clinical material on a form provided by the Secretary. C. List of Reportable Diseases and Conditions. 1. As required to report in Regulation .04A(1)—(3), (5), and (6) of this chapter. 2. The time frame for reporting is specified in Regulation .04C of this chapter. 3. Clinical material shall be submitted according to §B of this regulation. 4. Any grouping or clustering of patients having similar disease, symptoms, or syndromes that may indicate the presence of a disease outbreak. 5. Suspected hepatitis C as indicated by: (a) Any hepatitis C antibody results that are positive; (b) Any hepatitis C virus RNA results associated with the results in(a) of this footnote that are qualitative or quantitative, if the results are: (i) Positive; or (ii) Negative; and (c) Any hepatitis C virus RNA results associated with the results in(a) of this footnote if the hepatitis C virus is: (i) Detected; or (ii) Undetected. 6. Acquired immunodeficiency syndrome (AIDS) and human immunodeficiency virus (HIV), including CD4+ lymphocyte count and viral load, are reportable under COMAR 10.18. 7. Suspected syphilis as indicated by: (a) Any treponemal or non-treponemal results that are qualitative or quantitative, if the results are: (i) Positive; (ii) Reactive; or (iii) Inconclusive; and (b) Any negative or non-reactive results associated with the positive, reactive, or inconclusive results in(a) of this footnote. 8. Tuberculosis confirmed by culture and suspected tuberculosis as indicated by: (a) A laboratory confirmed acid-fast bacillus on smear; (b) An abnormal chest radiograph suggestive of active tuberculosis; (c) A laboratory confirmed biopsy report consistent with active tuberculosis; or (d) Initiation of two or more anti-tuberculosis medications. 9. Latent tuberculosis infection as indicated when: (a) There is a positive result on an Interferon Gamma Release Assay, Tuberculin Skin Test, or any other test indicating tuberculosis infection; and (b) Active or suspected tuberculosis has been ruled out. 10. Vibriosis, non-cholera, identified in any specimen taken from teeth, gingival tissues, or oral mucosa is not reportable. #### Regulation .04 Reporting Procedures. *COMAR 10.06.01.04* A. Sources of Reports and to Whom to Report. (1) An institution, as specified in Health-General Article, §18-202, Annotated Code of Maryland, and a health care provider who knows of a case of a reportable disease, condition, outbreak, or unusual manifestation shall report it to a health officer. (2) A teacher at any public, private, or parochial school or a child care provider at any child care facility shall report an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation as set forth in Regulation .03 of this chapter to the principal, school nurse, or superintendent or assistant superintendent or designee, who shall transmit to a health officer a report of the name and address of a child who appears to have a reportable communicable disease or who has been exposed to a reportable communicable disease. (3) The master or person in charge of a vessel or aircraft within the territory of the State shall report to the Secretary or a health officer at the nearest port of landing or entry, all known facts relating to the illness and physical condition of an individual aboard the vessel or aircraft who may have a reportable disease or condition, an outbreak, or an unusual manifestation. (4) Directors of Medical Laboratories or Laboratories that Possess Biological Agents as Defined in COMAR 10.10.11.03B(8). (a) The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall report: (i) Laboratory evidence of a reportable condition as specified in Regulation .03C of this chapter from examination of a human specimen acquired from an individual in this State; and (ii) Evidence of any other condition as requested by the Secretary. (b) The director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) located in a Maryland jurisdiction shall report to the health officer of that jurisdiction. (c) The director of a medical laboratory located outside of Maryland shall report to the Secretary. (d) If a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) forwards clinical materials out of State for testing, the originating medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) shall comply with this subsection by: (i) Reporting the results and submitting the clinical materials; or (ii) Ensuring that the results are reported and materials submitted. (e) When more than one specimen is taken from a patient during one disease episode, the director of a medical laboratory or a laboratory that possesses a biological agent as defined in COMAR 10.10.11.03B(8) need not report every test result of a specimen that shows evidence of the same disease in that patient if: (i) At least one positive test result is reported; and (ii) A health officer has agreed that all test reports do not need to be reported. (5) Any individual having knowledge of an animal bite shall report the bite according to the requirements of COMAR 10.06.02. (6) The owner or operator of a food establishment as defined in Health-General Article, §21-301, Annotated Code of Maryland, shall report to a health officer an occurrence of a reportable disease or condition, an outbreak, or an unusual manifestation. B. Method and Content of Reports. (1) A person, as listed in §A(1)—(4) of this regulation, shall report: (a) In writing on a form provided by the Secretary; or (b) In a format approved by the Secretary, when electronic submittal is available. (2) The report shall include at a minimum the: (a) Date of the report; (b) Patient's name including first and last names and middle initial; (c) Residence address of the patient including: (i) House or apartment number; (ii) Street; (iii) City or town; (iv) State; and (v) Zip code; (d) Telephone number including area code; (e) Date of birth; (f) Sex; (g) Race; (h) Ethnicity; (i) Pregnancy status if applicable; and (j) Other epidemiologic information as specified by the Secretary or the health officer. (3) In addition to what is specified in §B(2) of this regulation, institutions and health care providers, school and child care facility personnel, and masters of vessels or aircraft as listed in §A(1)—(3) of this regulation shall report: (a) The date of onset of symptoms; (b) The diagnosis; (c) For syphilis, gonococcal infection, and Chlamydia trachomatis infection, the treatment given; and (d) Any laboratory information supporting the diagnosis of the disease or condition, as requested. (4) A director of a medical laboratory, in addition to what is specified in §B(2) of this regulation, shall report the: (a) Name, address, telephone number, and federal Clinical Laboratory Improvement Amendments (CLIA) certificate number of the laboratory performing the test; (b) Date the specimen was received by the laboratory; (c) Accession number or other unique identifier for the specimen; (d) Type of test performed and the results, including: (i) Reference range; (ii) Quantitative results; and (iii) Results of speciating, grouping, or typing of organisms; (e) Date of specimen collection; (f) Type of specimen, for example, blood, urine, stool, or mucus, and the site of specimen collection, for example, cervix, eye; (g) Date of the laboratory result; (h) Name, address including number and street, city, state, and zip code, and phone number including area code of the health care provider who ordered the test; (i) Name, address including number and street, city, state, and zip code, and phone number including area code of the facility that ordered the test; and (j) For hepatitis C infection: (i) Signal-to-cut-off ratios and critical values; (ii) Hepatitis A IgM results; and (iii) Hepatitis B IgM test results. C. Timing of Reports. (1) If the Secretary requires an immediate report, the person making the report: (a) Shall communicate directly with an individual in person or by telephone; and (b) May not leave a message on an answering device. (2) A health care provider and a director of a medical laboratory shall report according to the time frame in Regulation .03C of this chapter. (3) School and child care facility personnel, a master of a vessel or aircraft, and the owner or operator of a food establishment shall report immediately. (4) A health officer shall transmit to the Secretary, by mail or as otherwise specified by the Secretary, all information obtained: (a) Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or (b) Within a shorter amount of time than 24 hours as specified by the Secretary. (5) The Secretary shall transmit to the health officer of the jurisdiction where the patient resides, by mail or as otherwise specified by the Secretary, all information related to the notice of a reportable condition provided by a director of a medical laboratory located outside of Maryland: (a) Within 24 hours after receiving notice of a disease or condition listed in Regulation .03C of this chapter; or (b) Within a shorter amount of time than 24 hours as specified by the Secretary. #### Regulation .05 Record Maintenance and Confidentiality. *COMAR 10.06.01.05* A. The custodian of a report identifying an individual that was filed by a reporting source (Regulation .04A) in compliance with the provisions of Health-General Article, §§18-201, 18-202, and 18-205, Annotated Code of Maryland: (1) Shall keep the report and record confidential; (2) May not open a report or record to public inspection; (3) Shall release a report or record or respond to a subpoena for a report or record in criminal or civil proceeding only pursuant to court order sealing the record; and (4) Shall make a record or report available to a governmental agency performing its lawful duties as authorized by an act of the Maryland General Assembly or the United States Congress when the Secretary determines that the release of information is necessary to protect the public health or to prevent the spread of an infectious or contagious disease. B. A report identifying an individual that was filed by a reporting source, as set forth under Regulation .04A of this chapter, in compliance with the provisions of Health-General Article, §§18-201, 18-202, and 18-205, Annotated Code of Maryland, and all information collected in connection with a report, are not medical records under Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. C. Communication with a Health Care Provider or Patient. (1) The Secretary or a health officer may discuss a laboratory report with the attending physician or other health care provider caring for a patient. (2) The Secretary or a health officer may communicate with a patient directly to discuss a laboratory report if: (a) The physician or other health care provider caring for a patient is not reasonably available; and (b) The Secretary or health officer records the date and time of the efforts to contact the physician or other health care provider caring for the patient and documents the: (i) Name of the individual with whom a message was left; or (ii) Identification given by the answering machine, if a message was left on an answering machine. #### Regulation .06 General Control Measures. *COMAR 10.06.01.06* A. Necessary Action. The Secretary or health officer shall: (1) Take any action or measure necessary to prevent the spread of communicable disease or to control a reportable disease and condition; and (2) Issue, when necessary, special instructions for control of a disease or condition. B. Epidemiologic Investigations. (1) A health officer shall respond to each reported outbreak or suspected outbreak of disease within the health officer's jurisdiction in order to collect data to assist in establishing adequate control measures. (2) A health officer shall investigate a reported case or suspect case of a condition as requested by the Secretary. (3) The Secretary may, in conjunction with the health officers, conduct the epidemiologic investigation for each reported case or suspected case in an outbreak involving two or more jurisdictions or states. (4) An individual, a business, a facility, or an agency, including a health care provider, school or child care facility personnel, a master of a vessel or aircraft, or a medical laboratory director, shall make available to the Secretary or a health officer all records and information necessary to the epidemiologic response or investigation. C. A health officer or the Secretary shall order cessation of operation of a business or facility determined or suspected to be a threat to public health until the public health threat is determined by the health officer to have ceased. D. Carrier Approval. (1) A health officer shall grant or deny approval to a carrier of an infectious agent to work in any of the following occupations involving: (a) Care of young children; (b) Care of the elderly; (c) Food handling; and (d) Patient care. (2) A health officer shall grant or deny approval to a carrier of an infectious agent to attend a: (a) School; or (b) Child care facility. (3) A health officer shall consider the following when granting or denying approval to a carrier of an infectious agent to work in occupations or to attend settings listed under §D(1) and (2) of this regulation: (a) The seriousness of the disease; (b) The route or routes of transmission of the disease; (c) The contagiousness of the disease; (d) The behavior, neurological development and condition, and physical condition of the carrier; (e) The susceptibility to the disease of those likely to be exposed to the carrier in the occupation or setting; (f) The precautions that may be taken to minimize or eliminate the danger of transmission; and (g) Precedents in the practice of public health. E. Control of Food Handlers. A case with any of the following diseases may not serve or handle, in any manner whatsoever, food intended for public consumption: (1) Disease causing diarrhea, unless physician-certified as noninfectious; (2) Cholera; (3) Escherichia coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC), as discussed in Regulation .08-3 of this chapter; (4) Hepatitis A, as discussed in Regulation .10 of this chapter; (5) Salmonellosis, as discussed in Regulation .16 of this chapter; (6) Shigellosis, as discussed in Regulation .19 of this chapter; and (7) Typhoid or Paratyphoid fever or carrier of Salmonella Typhi or Paratyphi, as discussed in Regulation .21 of this chapter. F. Control of Communicable Diseases in Schools and Child Care Facilities. (1) A health officer shall: (a) Maintain the right to make physical inspections of pupils, teachers, or other persons attending, employed, or volunteering in schools or child care facilities whenever, in the judgment of the health officer, the inspections are necessary to investigate a suspected communicable disease; and (b) Determine whether enrollees, pupils, or other individuals attending schools or child care facilities have received the immunizations required under COMAR 10.06.04, 13A.15.03.02, or 13A.16.03.04. (2) The principal or other person in charge of any school or child care facility shall comply with a measure or special instruction issued by the Secretary or a health officer under Regulation .06A of this chapter. G. Use of Sterile Instruments or Equipment. An individual who performs a procedure that penetrates the skin or mucous membrane of another individual shall: (1) Utilize only sterile instruments or equipment for the procedure; (2) Discard, after a single use, in accordance with COMAR 10.06.06, 26.13.11, and 26.13.12, any instruments or equipment designed for single use; and (3) Clean and sterilize before reuse any instruments or equipment designed for multiple use. H. Skin-Penetrating Body Adornment Procedures — Infection Control. (1) An individual who performs a skin-penetrating body adornment procedure shall: (a) Disclose the risks of the procedure, obtain the client's written consent for the performance of the procedure or, in the case of a minor, the consent of the parent or guardian, and retain the consent on file for a period of 3 years and make it available to the health officer, if requested; (b) Maintain records of the name of the customer, the date and type of procedure performed, and the technician performing the procedure for a period of 3 years and make these records available to the health officer, if requested; (c) Perform the procedure in a separate, enclosed room that has adequate lighting, and floors, walls, and a ceiling that are constructed to be smooth, impervious, and washable; (d) Use only sterile instruments, equipment, and bandages; (e) Wash both hands using soap and running water and dry the hands using individual single-use towels before and after each procedure; (f) Wear single-use disposable latex or vinyl gloves for each procedure and discard the gloves after the procedure is completed; (g) Wear a gown and face shield, or goggles and a mask, if spattering of blood is likely to occur during the procedure; (h) Cleanse the client's skin before and after the procedure; (i) Discard, after a single use, in accordance with COMAR 10.06.06, 26.13.11, and 26.13.12, any instruments or equipment designed for single use or any blood-soiled article; (j) Clean and sterilize before reuse any instruments or equipment designed for multiple use; (k) Provide written after-care instructions to the client; (l) Use standard precautions in all situations where exposure to blood or body fluids may occur and comply with all applicable State and federal laws and regulations regarding worker protection; and (m) Post the following notice in a prominent place: (2) An individual who performs a procedure that penetrates the skin or mucous membrane may not: (a) Perform a procedure on skin or mucous membrane that has a rash, infection, or other lesion; (b) Perform a procedure when the person performing the procedure has an infected or bleeding lesion on the hands; (c) Use a styptic pencil or alum block to staunch bleeding; or (d) Reuse instruments or equipment intended for single use. (3) A health officer may investigate complaints received regarding compliance with this section. #### Regulation .07 Minimum Control Measures for Specific Diseases or Conditions. *COMAR 10.06.01.07* A. The definitions of terms used in the text and the recommendations for control included in the Control of Communicable Diseases Manual are accepted as official and applicable to the control of disease within this State under the regulations of the Secretary, except in those instances in which the recommendations may be in conflict with Regulation .06A or Regulations .08—.21 of this chapter, in which case the regulations of the Secretary or special instructions of the Secretary or a health officer shall take precedence. B. The diseases and conditions described in Regulations .08—.21 of this chapter are subject to specific requirements and control procedures as specified. #### Regulation .08 Amebiasis. *COMAR 10.06.01.08* A. Control of a Case. A case may not participate in an occupation involving patient care, care of young children or the elderly, and food handling until chemotherapy is completed and 24 hours after diarrhea has ceased. B. Control of Contacts. (1) A health officer shall investigate household and close contacts whose occupations involve food handling, patient care, and care of young children or the elderly. (2) A contact who has diarrhea shall submit three fecal specimens for examination. If a specimen is positive for Entamoeba histolytica, the contact becomes a case, and the control measures specified in §A of this regulation apply. C. Infection Control. Health care providers shall practice standard precautions. #### Regulation .08-1 Campylobacteriosis. *COMAR 10.06.01.08-1* A. Control of a Case. (1) For a case with diarrhea due to or presumed due to campylobacteriosis, a health officer shall restrict or exclude a case from: (a) Attending a child care facility; or (b) Participating in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (2) For a case who has been without diarrhea for at least 24 hours, unless a health officer otherwise restricts or excludes the case based on Regulation .06D of this chapter, the case may: (a) Attend a child care facility; and (b) Participate in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (3) If a health officer has restricted or excluded a case under §A(1) of this regulation or Regulation .06D of this chapter, the health officer shall approve resumption of child care attendance or occupational duties when: (a) The case's fecal cultures are Campylobacter-free on two consecutive specimens collected: (i) Not less than 24 hours apart; and (ii) If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics; or (b) The health officer determines that the likelihood of disease transmission is low. B. Control of Contacts at Increased Risk of Transmitting Campylobacteriosis. (1) A health officer shall restrict or exclude a contact who has diarrhea from child care or an occupational setting until at least 24 hours after diarrhea ceases if the contact is in the household of a case or is a close contact who: (a) Attends a child care facility; or (b) Participates in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (2) If an individual is a contact of a case as specified in §B(1) of this regulation, and that individual has diarrhea at the time of the health department's investigation of the case, then the contact shall submit for examination two fecal specimens taken: (a) Not less than 24 hours apart; and (b) If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics. (3) If either of the specimens referred to in §B(2) of this regulation is positive for Campylobacter, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply. C. Infection Control. A health care provider shall practice standard precautions. D. Control of Carriers. A health care provider shall apply the control measures specified in §A of this regulation to carriers in addition to cases. #### Regulation .08-2 Cholera (Vibrio cholera O1 or O139). *COMAR 10.06.01.08-2* A. Control of a Case. (1) For a case with diarrhea due to or presumed due to cholera, a health officer shall restrict or exclude a case from: (a) Attending a child care facility; or (b) Participating in an occupation involving; (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (2) For a case who has been without diarrhea for at least 48 hours, unless a health officer otherwise restricts or excludes the case based on Regulation .06D of this chapter, the case may: (a) Attend a child care facility; and (b) Participate in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (3) If a health officer has restricted or excluded a case under §A(1) of this regulation or Regulation .06D of this chapter, the health officer shall approve resumption of child care attendance or occupational duties when: (a) The case's fecal cultures are Vibrio-free on two consecutive specimens collected: (i) Not less than 24 hours apart; and (ii) If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics; or (b) The health officer determines that the likelihood of disease transmission is low. B. Control of Contacts at Increased Risk of Transmitting Cholera. (1) A health officer shall restrict or exclude from child care or an occupational setting a contact who has diarrhea, until at least 48 hours after diarrhea ceases, if the contact is in the household of a case or is a close contact who: (a) Attends a child care facility; or (b) Participates in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (2) If an individual is a contact of a case as specified in §B(1) of this regulation, and that individual has diarrhea at the time of the health department's investigation of the case, then the contact shall submit for examination two fecal specimens taken at: (a) Not less than 24 hours apart; and (b) If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics. (3) If either of the specimens referred to in §B(2) of this regulation is positive for Vibrio cholera, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply. #### Regulation .08-3 Escherichia coli O157:H7 and Other Shiga-Like Toxin Producing Escherichia coli (STEC). *COMAR 10.06.01.08-3* A. Control of a Case. (1) A case may not attend a child care facility until: (a) The case’s fecal cultures or stool Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or (b) A health officer approves readmission based on the low likelihood of disease transmission. (2) A case, with or without diarrhea, may not participate in occupations involving food handling, patient care, or care of young children or the elderly until: (a) The case’s fecal cultures or stool Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or (b) A health officer approves resumption of occupational duties based on the low likelihood of disease transmission. B. Control of Contacts. (1) A health officer shall require a culture of feces or stool Shiga-like toxin test only from a household member or other close contact who attends a child care facility or whose occupation involves food handling, patient care, or care of young children or the elderly. (2) A household member or other close contact shall submit for examination two fecal specimens taken at an interval of not less than 24 hours apart. (3) If either of the specimens submitted pursuant to §B(2) of this regulation is positive for E. coli O157:H7, other Shiga-Like Toxin Producing Escherichia coli (STEC), or Shiga-like toxin, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply. (4) A household member or other close contact who currently has diarrhea or who has had an onset of diarrhea in the past 3 weeks may not attend a child care facility until: (a) The household member or other close contact is without diarrhea for at least 24 hours and fecal cultures or Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or (b) A health officer approves readmission based on the low likelihood of disease transmission. (5) A contact who currently has diarrhea or who has had an onset of diarrhea within the past week may not participate in occupations involving food handling, patient care, or care of young children or the elderly until: (a) The contact is without diarrhea for at least 24 hours and fecal cultures or Shiga-like toxin tests are free of E. coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC) on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or (b) A health officer approves resumption of occupational duties based on the low likelihood of disease transmission. C. Infection Control. A health care provider shall practice standard precautions. #### Regulation .09 Foodborne and Waterborne Diseases. *COMAR 10.06.01.09* A. Control of a Case or Contacts. If one of the following diseases is identified, a health officer shall follow the procedures detailed in this chapter for the specific disease: (1) Campylobacteriosis; (2) Cholera; (3) Escherichia coli O157:H7 and other Shiga-Like Toxin Producing Escherichia coli (STEC); (4) Hepatitis, viral type A; (5) Salmonellosis; (6) Shigellosis; and (7) Typhoid fever (Salmonella Typhi) or paratyphoid fever (Salmonella Paratyphi A, Salmonella Paratyphi B tartrate negative, and Salmonella Paratyphi C). B. Investigation and Control Measures. (1) A food establishment as defined in Health-General Article, §21-301, Annotated Code of Maryland, shall provide to a health officer the information the health officer or the Secretary determines to be necessary and pertinent to the investigation. (2) A health officer or the Secretary shall investigate the source, inspect food establishments, and collect samples of suspected foods and clinical specimens from food service workers and cases or contacts in an effort to determine the cause of a foodborne illness. (3) A health officer or the Secretary shall submit all samples for laboratory examination. (4) A health officer or the Secretary may detain a food item, issue a public notice requiring the recall or return of a food item, or prohibit the serving of food at a food service facility, until it is determined whether the food item or the facility is implicated as a source of illness. #### Regulation .10 Hepatitis, Viral Type A. *COMAR 10.06.01.10* A. Control of a Case. A case may not participate in an occupation involving food handling, patient care, or care of young children or the elderly for 1 week after onset of jaundice, or for 2 weeks after the onset of illness, if not jaundiced. B. Control of Contacts. For an individual who previously has not received hepatitis A vaccine, the physician in attendance or a health officer shall offer a single dose of single antigen hepatitis A vaccine or immune globulin to contacts for prophylaxis: (1) As soon as possible, but within 2 weeks of exposure to household, sexual, child care, or other contacts as determined by a health officer; and (2) According to the following recommendations: (a) For a previously unvaccinated healthy individual 12 months old to 40 years old, single antigen hepatitis A vaccine at the age appropriate dose is recommended; (b) For a previously unvaccinated individual older than 40 years old, immune globulin is recommended and single antigen hepatitis A vaccine may be used if: (i) Immune globulin is not available; and (ii) The individual is healthy; or (c) For a previously unvaccinated child younger than 12 months old, an immunocompromised individual, an individual with chronic liver disease, or an individual for whom vaccine is contraindicated, immune globulin is recommended. C. Infection Control. Health care providers shall practice standard precautions. #### Regulation .11 Hepatitis, Viral Type B. *COMAR 10.06.01.11* A. Control of a Case. A physician in attendance upon a case having viral hepatitis type B shall educate that case on the: (1) Risks of sexual transmission, household contact transmission, maternal-infant transmission, and transmission by the sharing of hypodermic needles and other drug paraphernalia; (2) Availability of hepatitis B vaccine and hepatitis B immune globulin for contacts who have had sexual contact with a case of hepatitis B within the preceding 14 days, contacts who have percutaneous exposures to hepatitis B, and infants born to case mothers who carry hepatitis B virus at delivery, and the need for referring those contacts to health care providers for preventive treatment; (3) Importance of vaccination for viral hepatitis type A if the case is not already immune by reason of prior infection or prior vaccination; and (4) Importance of testing pregnant women for hepatitis B surface antigen at each pregnancy. B. Control of Contacts. A physician or health officer in attendance upon a contact of viral hepatitis type B shall: (1) Educate that contact about the availability of vaccine and hepatitis B immune globulin for contacts with exposure to the case’s blood or other infectious body fluids; (2) Recommend preventive treatment consistent with current Centers for Disease Control and Prevention guidelines based on type of exposure; and (3) Require that infants born to hepatitis B surface antigen positive mothers: (a) Receive hepatitis B immune globulin and the first dose of hepatitis B vaccine within 12 hours of birth; (b) Receive the rest of the vaccination series; and (c) Are tested for hepatitis B surface antigen and hepatitis B surface antibody at 9 to 15 months old. C. Infection Control. Health care providers shall practice standard precautions. #### Regulation .11-1 Hepatitis, Viral Type C. *COMAR 10.06.01.11-1* A. Control of a Case. A physician in attendance upon a case of viral hepatitis type C shall educate that case on: (1) The risks of transmission of viral hepatitis type C by: (a) Sharing hypodermic needles and other injecting drug paraphernalia; (b) Sexual transmission; (c) Maternal-child transmission; (d) Parenteral or permucosal exposure to blood or other infectious body fluids; (e) Chronic hemodialysis; (f) Transfusion; and (g) Transplantation; (2) How to reduce the risk of transmission of viral hepatitis type C to other individuals; (3) The importance of an individual health evaluation to determine if treatment should be recommended; (4) The importance of vaccination for viral hepatitis types A and B if the case is not already immune by reason of prior infection or prior vaccination; and (5) The prevention of further liver injury or more serious liver disease or liver failure. B. Control of Contacts. A physician or health officer in attendance upon a contact of viral hepatitis type C shall educate the contact about: (1) Any risk factors and signs of infection due to viral hepatitis type C; (2) Testing that is available to determine whether an infection due to viral hepatitis type C is present, and facilitate that testing if medically appropriate or if requested by the contact; and (3) How to reduce the contact's risk of receiving viral hepatitis type C from others. C. Infection Control. A health care provider shall: (1) Practice standard precautions; and (2) Implement and maintain, in hemodialysis centers and other settings where viral hepatitis type C transmission is known to be an increased risk, additional infection control measures based upon the Centers for Disease Control and Prevention recommendations for prevention and control of hepatitis C infection and HCV-related chronic disease, as directed by the Secretary to reduce disease transmission. D. Education. The Secretary, with the assistance of the health officer, shall provide professional and public education and informational materials on viral hepatitis type C, modes of transmission, and prevention of viral hepatitis type C. #### Regulation .12 Measles (Rubeola). *COMAR 10.06.01.12* A. Control of a Case. A health officer or health care provider shall recommend that a case may not attend a school, workplace, or child care facility from the onset of the illness at least through the 4th day after the rash appears. B. Control of Contacts. (1) Nonimmune Contacts. (a) Nonimmune individuals for measles, in general, are people who: (i) Have not received two doses of measles containing vaccine on or after the first birthday; (ii) Have no documentation of immunity or disease; or (iii) Were born in or after 1957. (b) A health officer or health care provider shall recommend that: (i) Nonimmune contacts receive measles vaccine within 72 hours of exposure if not medically contraindicated; and (ii) Nonimmune household or other close contacts, particularly contacts younger than 1 year old, pregnant women, persons with immunodeficiencies, or those for whom the vaccine is contraindicated, be given immune globulin within 6 days of exposure. (c) A health officer shall restrict or exclude a nonimmune contact from attending a school, health care facility, child care facility, or workplace until 21 days after the onset of rash in the last case of measles. (2) A health officer: (a) May require all nonimmune individuals to be excluded from a school, workplace, or child care facility when a case of measles is diagnosed or suspected in a student, employee, or volunteer of the school or facility; and (b) Shall authorize readmission upon documented proof of immunity in the form of immunization record, serologic test, or the low likelihood of disease transmission. C. Infection Control. Health care providers shall practice airborne precautions from the onset of illness at least through the 4th day after the rash appears. D. Proof of Immunity for Health Care Workers. (1) A worker born in or after 1957 working at least 20 hours each week who is newly retained as medical staff, a direct or contractual employee, or a volunteer of a hospital classified as a “general hospital” under Health-General Article, §19-307, Annotated Code of Maryland, shall have documentation of receipt of two doses of live measles virus vaccine after becoming 1 year old or proof of immunity by blood test for antibody to rubeola. The hospital shall keep the measles vaccination or immunity status of each worker on file. (2) Exemptions. (a) A hospital shall grant a medical exemption for any worker who presents a written statement from a licensed physician or a health officer indicating that immunization against measles is medically contraindicated or detrimental to the worker's health. The statement shall indicate whether the exemption should be permanent or temporary. If the exemption is temporary, the statement shall indicate the date on which the worker is to receive the immunization. A hospital shall withdraw a temporary medical exemption on the day following that date. If the exemption is permanent, the hospital shall maintain a record of the worker's measles antibody test results. (b) If a worker objects to an immunization upon the grounds that it conflicts with the worker's bona fide religious beliefs and practices, the hospital shall grant a religious exemption to the worker for the immunization. The hospital shall maintain a record of the worker's measles antibody test results. #### Regulation .12-1 Mumps. *COMAR 10.06.01.12-1* A. Control of a Case. A health officer or health care provider shall recommend that a case may not attend a school, workplace, or child care facility from the onset of illness through the 5th day after onset of parotitis. B. Control of Contacts. (1) Nonimmune Individuals. (a) Nonimmune individuals for mumps, in general, are people who: (i) Have not received two doses of mumps containing vaccine on or after the first birthday; (ii) Have no documentation of immunity or disease; or (iii) Were born in or after 1957. (b) A health officer shall restrict or exclude a nonimmune contact from attending a school, health care facility, child care facility, or workplace until 25 days after the onset of parotitis in the last case of mumps. (2) A health officer: (a) May require all nonimmune individuals to be excluded from a school, workplace, or child care facility when a case of mumps is diagnosed or suspected in a student, employee, or volunteer of the school or facility; and (b) Shall authorize readmission upon documented proof of immunity in the form of: (i) An immunization record; (ii) A serologic test; or (iii) The low likelihood of disease transmission. C. Infection Control. A health care provider shall practice droplet precautions for 5 days after onset of parotitis. #### Regulation .12-2 Pertussis. *COMAR 10.06.01.12-2* A. Control of a Case. (1) A health officer or health care provider shall recommend that a case may not attend school, a workplace, or a child care facility until the patient has received at least 5 days of appropriate antibiotics. (2) If a case does not receive antibiotics, a health officer shall restrict or exclude the case from attending a school, health care facility, child care facility, or workplace for 3 weeks after onset of cough. B. Control of Contacts. A health officer may: (1) Require all inadequately immunized household contacts younger than 7 years old to be excluded from schools, child care facilities, and public gatherings: (a) For 21 days after last exposure; or (b) Until the case patients and contacts have received 5 days of appropriate antibiotics; (2) Require all contacts to verify immunization status and be brought up to date if not adequately immunized to protect against subsequent exposure; and (3) Require antibiotic prophylaxis for contacts of cases. C. Infection Control. A health care provider shall practice droplet precautions for the shorter of: (1) 21 days after onset of cough; or (2) When a case has been on appropriate antibiotics for 5 days. #### Regulation .13 Psittacosis. *COMAR 10.06.01.13* A. There is no control of a human case or contacts. B. Infection Control. A health care provider shall practice appropriate disinfection and disposal of respiratory discharges. C. The sale and distribution of exotic birds and handling of exotic birds which are cases or suspected cases of avian psittacosis are subject to Health-General Article, §§24-101—24-110, Annotated Code of Maryland. D. The Department recommends that the Compendium of Measures To Control Chlamydia psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), 2017, by the National Association of State Public Health Veterinarians, be followed for ill birds and birds that carry psittacosis. #### Regulation .14 Rabies. *COMAR 10.06.01.14* A. Control of a Case (Human). A health care provider shall apply contact isolation to the case for the period of communicability. B. Control of Contacts. A health officer or health care provider shall evaluate individually a close contact or hospital contact to determine the need for post-exposure rabies prophylaxis. A health care provider shall warn an immediate attendant of the hazard of infection. C. Infection Control. A health care provider shall practice contact isolation. D. Confinement or Examination of Animals. A health officer or the Maryland Public Health Veterinarian shall direct the quarantine, examination, control, and disposition of any animal that bites or otherwise potentially exposes a human to rabies, according to COMAR 10.06.02. #### Regulation .15 Rubella (German Measles). *COMAR 10.06.01.15* A. Control of a Case. A health officer or health care provider shall recommend that a case: (1) Be isolated from a woman of childbearing age who is not immune or is of unknown immunity, from the onset of illness through the 7th day after appearance of the rash; and (2) May not attend a school, workplace, or child care facility from the onset of the illness through the 7th day after the appearance of the rash. B. Control of Contacts. (1) Nonimmune Contacts. (a) Nonimmune individuals for rubella, in general, are people who: (i) Have not received at least one dose of rubella containing vaccine on or after the first birthday; (ii) Have no documentation of immunity or disease; or (iii) Were born in or after 1957. (b) A health officer shall restrict or exclude a nonimmune contact from attending a school, health care facility, child care facility, or workplace until 21 days after the onset of rash in the last case of rubella. (2) A health officer: (a) May require all nonimmune individuals to be excluded from a school, workplace, or child care facility when a case of rubella is diagnosed or suspected in a student, employee, or volunteer of the school or facility; and (b) Shall authorize readmission by documented proof of immunity in the form of an immunization record, serologic test, or the low likelihood of disease transmission. C. Infection Control. A health care provider shall practice droplet precaution for 7 days after onset of the rash. D. Proof of Immunity for Health Care Workers. (1) A worker born in or after 1957 working at least 20 hours each week who is newly retained as medical staff, a direct or contractual employee, or a volunteer of a hospital classified as a “general hospital” under Health-General Article, §19-307, Annotated Code of Maryland, shall have documentation of receipt of either one dose of live rubella virus vaccination on or after becoming 1 year old or proof of immunity by blood test for antibody to rubella. The hospital shall keep the vaccine or immunity status of each worker on file. (2) Exemptions. (a) A hospital shall grant a medical exemption for any worker who presents a written statement from a licensed physician or a health officer indicating that immunization against rubella is medically contraindicated or detrimental to the worker's health. The statement shall indicate whether the exemption should be permanent or temporary. If the exemption is temporary, the statement shall indicate the date on which the worker is to receive the immunization. A hospital shall withdraw a temporary medical exemption on the day following that date. If the exemption is permanent, the hospital shall maintain a record of the worker's rubella antibody test results. (b) If a worker objects to an immunization upon the grounds that it conflicts with the worker's bona fide religious beliefs and practices, the hospital shall grant a religious exemption to the worker for the immunization. The hospital shall maintain a record of the worker's rubella antibody test results. #### Regulation .16 Salmonellosis. *COMAR 10.06.01.16* A. Control of a Case. (1) For a case with diarrhea due to or presumed due to salmonellosis, a health officer shall restrict or exclude a case from: (a) Attending a child care facility; or (b) Participating in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (2) For a case who has been without diarrhea for at least 24 hours, unless a health officer otherwise restricts or excludes the case based on Regulation .06D of this chapter, the case may: (a) Attend a child care facility; and (b) Participate in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (3) If a health officer has restricted or excluded a case under §A(1) of this regulation or Regulation .06D of this chapter, the health officer shall approve resumption of child care attendance or occupational duties when: (a) The case’s fecal cultures are Salmonella-free on two consecutive specimens collected: (i) Not less than 24 hours apart; and (ii) If antibiotics have been given, not sooner than 48 hours following discontinuation of antibiotics; or (b) The health officer determines that the likelihood of disease transmission is low. B. Control of Contacts at Increased Risk of Transmitting Salmonellosis. (1) A health officer shall restrict or exclude from child care or an occupational setting a contact who has diarrhea, until at least 24 hours after diarrhea ceases, if the contact is in the household of a case or is a close contact who: (a) Attends a child care facility; or (b) Participates in an occupation involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (2) If an individual is a contact of a case as specified in §B(1) of this regulation, and that individual has diarrhea at the time of the health department's investigation of the case, then the contact shall submit for examination two fecal specimens taken not: (a) Less than 24 hours apart; and (b) Sooner than 48 hours following discontinuation of antibiotics if antibiotics have been given. (3) If either of the specimens referred to in §B(2) of this regulation is positive for Salmonella, a health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply. C. Infection Control. A health care provider shall practice standard precautions. D. Control of Carriers. A health care provider shall apply the same control measures to carriers as to cases. #### Regulation .17 Syphilis and HIV. *COMAR 10.06.01.17* A. Control of a Case. (1) For an individual who appears to have or who has syphilis in a stage which is or may become communicable, or HIV, a physician shall instruct the individual in the use of any measure and render any treatment which may be necessary to prevent the spread of the disease. (2) An individual under medical observation for diagnosis of syphilis or HIV shall remain under medical supervision until the: (a) Observation for diagnosis has been completed; (b) Syphilis or HIV, if present, has been reported to a health officer; (c) Individual with syphilis has had the treatment that is necessary for the protection of the public health; and (d) Individual with HIV has entered into HIV medical care. (3) A physician shall report to a health officer within 1 working day and in writing the name and address of an individual who is: (a) Receiving or has received treatment for syphilis; or (b) Under medical observation for diagnosis or treatment of syphilis in an infectious or potentially infectious stage, who fails to return for observation or treatment within 1 week of the date of a missed appointment, and is not known to the attending physician to be under medical observation or treatment elsewhere for this infection. (4) A health officer shall: (a) Investigate an individual reported to the health officer under the provisions of §A(3) of this regulation or Health-General Article, §18-201.1, Annotated Code of Maryland, who is within the health officer’s territorial jurisdiction; (b) Take such measures as may be deemed necessary for the protection of the public health; and (c) Forward to the Secretary immediately a report of an individual reported under the provisions of §A(3) of this regulation or Health-General Article, §18-201.1, Annotated Code of Maryland, who is outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction. B. Control of Contacts. (1) A physician in attendance upon a patient having syphilis or HIV: (a) Shall endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by: (i) Requesting a health officer to conduct a contact investigation of any case of syphilis or HIV; or (ii) Interviewing the patient in order to ascertain the names, descriptions, addresses, telephone numbers, and email addresses of those with whom the patient has had potentially infectious contact; (b) Shall report immediately to a health officer an individual identified as having had potentially infectious contact with a patient having syphilis reported under the provisions of §A(3) of this regulation; and (c) May report to a health officer an individual identified as having had potentially infectious contact with a patient having HIV reported under Health-General Article, §18-201.1, Annotated Code of Maryland, if a patient that has been informed of the patient’s HIV positive status refuses to notify the patient’s sexual and needle-sharing partners. (2) A health officer shall: (a) Investigate and notify immediately an individual reported under the provisions of §B(1)(b) of this regulation, who is within the health officer’s jurisdiction, of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with syphilis or HIV; and (b) Forward immediately to the Secretary all reports of individuals who are outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction. (3) A reported individual shall: (a) Within 1 week of notification, be examined to ascertain whether the individual has been infected with syphilis or HIV; and (b) Be treated with a regimen appropriate for the stage of syphilis to which the individual has been exposed. C. Infection Control. A health care provider shall practice standard precautions. D. Congenital Syphilis. (1) A physician in attendance upon a pregnant woman shall: (a) Serologically test her for syphilis in accordance with Health-General Article, §18-307, Annotated Code of Maryland, by taking a blood sample and assuring the test is completed: (i) At the time the physician first examines the woman, either at the first prenatal visit or at the time of delivery if the woman has had no prenatal care; (ii) In the third trimester at the prenatal visit at 28 weeks of gestation or the first prenatal visit after 28 weeks of gestation; and (iii) At delivery, for high prevalence communities or high risk individuals; (b) Render appropriate treatment within 1 week whenever syphilis, in any stage, is diagnosed; and (c) Report the case to a health officer immediately. (2) A physician in attendance upon an infant born to an untreated woman who has a positive serological test for syphilis shall: (a) Evaluate the infant for possible congenital syphilis and render all indicated treatment; and (b) Report immediately to a health officer the following information: (i) The name, address, and telephone number of the mother; (ii) The results of the serological testing, including titers; and (iii) The results of the medical evaluation for congenital syphilis for the infant. (3) A health officer shall: (a) Investigate immediately an individual reported to the health officer under the provisions of §D(1)(c) and (2)(b) of this regulation, who is within the health officer's jurisdiction; and (b) Forward immediately to the Secretary a report of an individual reported under the provisions of §D(1)(c) and (2)(b) of this regulation, who is outside the health officer's jurisdiction for referral to a health officer of the proper jurisdiction. #### Regulation .18 Other Sexually Transmitted Infections. *COMAR 10.06.01.18* A. Control of a Case. (1) Hepatitis, viral type B, as discussed in Regulation .11 of this chapter. (2) A physician in attendance upon a person who appears to have, or who has a sexually transmissible disease in a stage which is or may become communicable, shall: (a) Instruct the person on the modes of transmission and the prevention of transmission; (b) Render any necessary treatment to the case; and (c) Advise the case to inform a sexual partner or partners of exposure and the need for examination and treatment. B. Control of Contacts. (1) Hepatitis, viral type B as discussed in Regulation .11 of this chapter (2) A physician in attendance upon an individual who is a sexual contact of a case of a sexually transmitted infection shall perform a medical examination and render indicated treatment. C. Prevention of Gonococcal Ophthalmia Neonatorum. (1) A birth-attending physician or certified nurse-midwife shall apply to both eyes of a newborn one of the following prophylactic agents: (a) A 1-percent silver nitrate solution provided in individual wax ampules for the prevention of gonococcal ophthalmia neonatorum; (b) Tetracycline ophthalmic ointment; or (c) Erythromycin ophthalmic ointment (USP). (2) A birth-attending physician or certified nurse-midwife shall document in a newborn's medical record the application of the prophylactic agent, the name of the agent used, and dose strength. #### Regulation .19 Shigellosis. *COMAR 10.06.01.19* A. Control of a Case. (1) A case may not attend a child care facility until: (a) The case's fecal cultures are Shigella-free on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or (b) A health officer approves readmission based on the low likelihood of disease transmission. (2) A case, with or without diarrhea, may not participate in occupations involving food handling, patient care, or care of young children or the elderly until: (a) The case's fecal cultures are Shigella-free on two consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, if antibiotics have been given; or (b) A health officer approves resumption of occupational duties based on the low likelihood of disease transmission. B. Control of Contacts. (1) A health officer shall require a culture of feces only from a household member or close contact who: (a) Attends a child care facility; or (b) Whose occupation involves: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly. (2) A contact shall submit for examination two fecal specimens taken at an interval of not less than 24 hours apart. (3) If either of the specimens collected under §B(2) of this regulation is positive for Shigella, the health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation shall apply. C. Infection Control. A health care provider shall practice standard precautions. #### Regulation .20 Tuberculosis. *COMAR 10.06.01.20* A. Control of a Case and Suspected Case. (1) A health care provider shall immediately send notification that they have a patient who is suspected of being in a communicable stage to the local health officer of the jurisdiction in which the patient is currently located. (2) A health care provider may not discharge a patient who is suspected of being in a communicable stage until the local health department of the jurisdiction in which the patient is located has been informed of and concurs with the planned discharge or release of the individual. (3) A health officer or health care provider shall isolate a patient who is in a communicable stage as long as the specific microorganism: (a) Is excreted by the patient; or (b) Can be isolated by culture in the case of multidrug resistant tuberculosis (MDR-TB) or extremely drug resistant tuberculosis (XDR-TB). (4) A patient fulfills the requirements of isolation as long as the patient receives adequate chemotherapy, is under medical supervision, and observes instructions for isolation issued by a health officer. (5) A health care provider shall place individuals with tuberculosis and suspected tuberculosis on a tuberculosis treatment regimen that is in accordance with current national and State standards of care, and that provide for direct observation by a trained health care worker of ingestion of each dose of medication. (6) A health officer or health care provider treating an individual with tuberculosis or suspected tuberculosis shall provide human immunodeficiency virus testing and counseling. (7) A health officer shall monitor the treatment of individuals with tuberculosis and suspected tuberculosis to determine if the treatment is appropriate. (8) A health officer may impose limitations on travel and place restrictions on hospital discharge for an individual with tuberculosis or suspected tuberculosis. (9) A health officer may remove the limitations and restrictions set forth in §A(8) of this regulation when appropriate and consistent with the individual's tuberculosis treatment plan. (10) A health officer or the Secretary shall manage tuberculosis patients who are noncompliant with tuberculosis treatment in accordance with Health-General Article, §§18-324 and 18-325, Annotated Code of Maryland. (11) A health officer may require an individual having tuberculosis in a noncommunicable stage to be under medical supervision, which may include physical isolation from others, if the individual refuses to receive adequate chemotherapy. B. Control of Contacts. A health officer shall: (1) Direct that testing for tuberculosis infection using a Centers for Disease Control and Prevention approved method be performed on contacts of cases of tuberculosis in a communicable stage; (2) Recommend appropriate treatment for latent tuberculosis infection; and (3) Provide for the supervised presumptive treatment of latent tuberculosis infection for a child younger than 5 years old identified as a close contact to a confirmed case or suspected case of active pulmonary tuberculosis. #### Regulation .21 Typhoid Fever (Salmonella Typhi) and Paratyphoid Fever (Salmonella Paratyphi A, Salmonella Paratyphi B tartrate negative, and Salmonella Paratyphi C). *COMAR 10.06.01.21* A. Control of a Case. (1) A case may not attend a child care facility until fecal specimens are Salmonella-free on three consecutive specimens collected not less than 24 hours apart and not sooner than 48 hours following discontinuation of antibiotics, or until a health officer approves readmission based on the low likelihood of transmission. (2) A case may not participate in occupations involving food handling, patient care, or care of young children or the elderly until fecal specimens are Salmonella-free on three consecutive specimens collected not less than 24 hours apart, and not sooner than 48 hours after discontinuation of antibiotics. (3) A health officer shall supervise a case and release a case from supervision only after fecal specimens are culture negative for Salmonella Typhi or Paratyphi on three consecutive specimens collected not: (a) Less than 24 hours apart; (b) Sooner than 48 hours following discontinuation of antibiotics; and (c) Earlier than 1 month after onset or date of first positive culture if asymptomatic. (4) If any one of the specimens required in §A(3) of this regulation is positive, at least three consecutive negative cultures of feces at intervals of 1 month within the 12 months following onset shall be required for release from supervision. (5) If a person continues to excrete Salmonella Typhi or Paratyphi at 12 months, the requirements of §D of this regulation apply. B. Control of Contacts of a Case. Household, sexual, and other close contacts of a case may not attend a child care facility or participate in occupations involving food handling, patient care, or care of young children or the elderly until two consecutive cultures of feces taken at least 24 hours apart are negative for Salmonella Typhi or Paratyphi. C. Infection Control. A health care provider shall practice standard precautions. D. Control of Carriers. (1) A health officer shall: (a) Monitor the location, occupation, and bacteriological status of a carrier of Salmonella Typhi or Paratyphi; (b) Keep a complete file of all pertinent data on the carrier; (c) Issue written instructions to the carrier concerning the restrictions upon and responsibilities of the carrier; (d) Notify the carrier of the availability of treatments that may eliminate carriage; (e) Contact each carrier in the health officer's jurisdiction at intervals of not more than 1 year to check on the carrier's occupation and address and to determine if all instructions are being followed; (f) Release a carrier from supervision only after there have been three consecutive negative cultures of feces, taken 1 month apart at least 48 hours after antibiotic treatment; and (g) Forward immediately to the Secretary a report of a carrier who has relocated outside the health officer's territorial jurisdiction for referral to the health officer of the proper jurisdiction. (2) A case or a case's physician shall submit the fecal specimens to the State Laboratory for the release of a carrier. (3) A carrier: (a) May not participate in occupations involving: (i) Food handling; (ii) Patient care; or (iii) Care of young children or the elderly; (b) Shall abide by Regulation .06D and E; and (c) Shall keep a health officer informed at all times of the carrier's address and occupation, and shall notify the health officer at once of any change in address or occupation. E. Control of Contacts of a Carrier. (1) A health officer shall require culture of feces of those household and close contacts: (a) Who attend a child care facility; or (b) Whose occupations involve: (i) Food handling; or (ii) Care of patients, young children, or the elderly. (2) A contact shall submit for examination two fecal specimens taken at an interval of not less than 24 hours apart. (3) If either of the specimens required in §E(2) of this regulation is positive for Salmonella Typhi or Paratyphi, then the health officer shall consider the contact to be a case, and the control measures specified in §A of this regulation apply. #### Regulation .22 Sale and Distribution of Reptiles. *COMAR 10.06.01.22* A. Scope. (1) Pursuant to the authority conferred upon the Secretary by Health-General Article, §18-219, Annotated Code of Maryland, the Secretary has determined that reptiles and reptile eggs are dangerous to human health and safety in that human contact with reptiles and reptile eggs may spread disease to humans. (2) The Secretary prohibits the sale or public distribution of turtles with a carapace length of less than 4 inches and viable reptile eggs. (3) The Secretary may permit the sale and public distribution of reptiles in accordance with specific requirements and conditions as stated in §B of this regulation. (4) This regulation does not apply to a turtle: (a) Used for agricultural purposes; (b) Used for scientific purposes; (c) Used for educational purposes as certified by a health officer; (d) Used for public exhibitions; or (e) That the Secretary determines is not a threat to human health and safety. (5) The requirements of this regulation are in addition to any requirement imposed by Natural Resources Article, Title 10, Subtitle 9, Annotated Code of Maryland, and regulations adopted under it. (6) The giving away of reptiles is subject to the crimes and punishments set forth in Criminal Law Article, §10-610, Annotated Code of Maryland. B. Reptile Sales. (1) A person may not sell in Maryland viable reptile eggs or live turtles with a carapace length of less than 4 inches, except as otherwise provided in §A(4) of this regulation. (2) A person may sell turtles with a carapace length of 4 inches or more and other live reptiles in Maryland if: (a) A caution notice with the text as indicated in §C of this regulation is: (i) Posted by the person selling reptiles; (ii) Posted within 3 feet of each display of reptiles; and (iii) A minimum of 8 x 11 inches in size; and (b) At the time of the sale of a reptile, the seller: (i) Furnishes the buyer with a copy of the caution notice; or (ii) Has the buyer sign a log or statement that the buyer has read the caution notice. C. Caution Notice. A person who sells reptiles shall post a caution notice that: (1) Is in 4 parts, each separated by a horizontal 4-point rule; (2) In part 1 has the word “Caution” set in 100-point Times Roman Bold; (3) In part 2 has the following paragraph set in 30-point Times Roman: “Reptiles and other pets may carry and transmit germs (including Salmonella) to humans. It is important to wash your hands thoroughly after handling reptiles and other pets or coming in contact with their water, food, housing material, or container. Do not allow pet water, food, or housing material to come in contact with your food or areas where food is prepared.”; (4) In part 3 has the following sentence set in 42-point Times Roman Bold: “Provide your reptiles and other pets with a clean home, a suitable diet, and other proper care.”; and (5) In part 4 has the following sentence set in 30-point Times Roman: “If you or any member of your family is prone to or has serious health problems or is pregnant or your family includes a child younger than 5 years old, you should consult your physician before purchase.” D. Penalties and Seizure of Contraband Reptiles. (1) Pursuant to Health-General Article, §§18-219 and 18-222, Annotated Code of Maryland, a person who imports, transports, sells, transfers, breeds, raises, keeps, or possesses any live turtle with a carapace length of less than 4 inches, other reptiles, or reptile eggs in violation of §§A—C of this regulation is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $500, or imprisonment not exceeding 1 year, or both. (2) An authorized law enforcement officer may seize a turtle with a carapace length of less than 4 inches, viable turtle and other reptile eggs, and other reptiles, which are considered a nuisance and a contraband pursuant to Health-General Article, §18-222, Annotated Code of Maryland, and §A of this regulation. #### Regulation .23 Communicable Disease Information Provided With Sale and Distribution of Pet Animals. *COMAR 10.06.01.23* To help prevent the spread of a communicable disease, a seller or a group of sellers who prepares or causes to be prepared a pamphlet, flyer, or other printed information on the handling of one or more pet animals and who distributes the pamphlet, flyer, or other printed information, shall ensure that the pamphlet, flyer, or other printed information stresses the: A. Importance of handwashing after contact with a reptile or other pet animals or its surroundings; and B. Need to consult a physician if one or more of the following individuals live in the household for which a pet animal is purchased: (1) A child younger than 5 years old; (2) A pregnant woman; or (3) An immunocompromised individual. #### Regulation .24 Control of Communicable Diseases in Pet Stores. *COMAR 10.06.01.24* A. A pet store shall utilize procedures to ensure prevention and control of diseases common to and shared among humans and animals. B. To ensure prevention and control of diseases common to and shared among humans and animals, the Department recommends that pet stores utilize the Compendium of Animal Rabies Prevention and Control, the Compendium of Measures To Control Chlamydophila psittaci Infection Among Humans (Psittacosis) and Pet Birds (Avian Chlamydiosis), and the Compendium of Measures to Prevent Disease Associated with Animals in Public Settings, issued by the National Association of State Public Health Veterinarians. C. A health officer shall annually inspect a pet store to determine compliance with §A of this regulation. D. A health officer: (1) May delegate the authority to conduct annual pet store inspections to another specified agency such as, but not limited to, local animal control; and (2) Shall execute and keep on file a written agreement with the delegated inspection agency. E. Enforcement. An authorized law enforcement officer or local animal control authority shall promptly enforce a written order of a health officer or the Maryland Public Health Veterinarian issued pursuant to COMAR 10.06.02. F. Penalty. The owner of a pet store refusing or failing to comply with the provisions of this regulation is subject to the penalties set forth in Health-General Article, §§18-222, 18-604, and 24-110, Annotated Code of Maryland. ### Chapter 02 — Communicable Diseases — Rabies **Authority:** Health-General Article, §§18-102, 18-312—18-320, and 18-604, Annotated Code of Maryland **Administrative History:** Effective date: April 27, 1977 (4:9 Md. R. 714) **Administrative History:** Preface and Regulation .01 recodified to Regulation .01 and Regulation .01-1, respectively, in July 1994 **Administrative History:** Regulation .09A, B amended effective February 14, 1994 (21:3 Md. R. 193) **Administrative History:** Regulations .01—.14 repealed and new Regulations .01—.14 adopted effective November 16, 1998 (25:23 Md. R. 1696) **Administrative History:** Regulation .01 amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .02B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); emergency status extended at 35:9 Md. R. 892; amended permanently effective March 24, 2008 (35:6 Md. R. 698) **Administrative History:** Regulation .02B amended effective February 15, 2016 (43:3 Md. R. 272); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .03C, D amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .03D amended effective May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .03E repealed effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .04 amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .04B, D amended effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .06E amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .07 amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .09 amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .10 amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .10B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); emergency status extended at 35:9 Md. R. 892; amended permanently effective March 24, 2008 (35:6 Md. R. 698) **Administrative History:** Regulation .11 amended effective September 14, 2015 (42:18 Md. R. 1174) **Administrative History:** Regulation .13B amended effective September 14, 2015 (42:18 Md. R. 1174); February 27, 2017 (44:4 Md. R. 253) #### Regulation .01 Scope. *COMAR 10.06.02.01* This chapter provides for cooperative rabies control efforts by the Department, local health officers, physicians, veterinarians, and other Maryland government agencies as guided by policy statements such as the Compendium of Animal Rabies Prevention and Control, issued annually by the National Association of State Public Health Veterinarians. #### Regulation .02 Definitions. *COMAR 10.06.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adequately vaccinated” means a graduate veterinarian at a public antirabies clinic or a licensed veterinarian has: (a) Immunized an animal against rabies in accordance with the current year's recommendations as circulated by the Department; and (b) Documented the rabies immunization by issuing a valid rabies certificate. (2) “Animal” means a nonhuman species of mammal. (3) “Animal exposed to a rabid animal” means an animal that is known or is suspected to have had a bite from or non-bite contact with another animal that is known or suspected to be infected with rabies. (4) “Apparently healthy” means an: (a) Animal shows no signs of illness suggestive of rabies; and (b) Investigation by the local health officer or the health officer’s designee shows that: (i) The animal has not had a change in health or behavior in the past 30 calendar days, including but not limited to lethargy, lameness, weakness, slowness of movement or gait, paralysis, or loss of appetite; or (ii) A licensed veterinarian, having examined the animal more than 30 days before the bite or non-bite contact, has identified and documented that behavior or health changes were caused by a condition unrelated to rabies. (5) “Area quarantine” means a geographic region designated by the Public Health Veterinarian within which animals of a species designated by the Public Health Veterinarian are subject to the restrictions specified in this chapter. (6) “Bite contact” means penetration of the skin by the teeth of an animal, regardless of whether blood is visible. (7) “Cat” means Felis catus. (8) “Custodian” means a caretaker or keeper of an animal, or the local animal control authority who has responsibility for an unclaimed animal. (9) “Department” means the Department of Health. (10) “Department-approved facility” means a facility that has prior written approval of the Department to quarantine rabies suspect animals. (11) “Dog” means Canis familiaris, not including canine hybrids. (12) “Domestic animal” means a species of mammal that is accustomed to living in or about the habitation of man and is dependent on man for food or shelter, including but not limited to dogs, cats, ferrets, and livestock. (13) “Feral dog or cat” means a dog or cat that: (a) Shows no evidence, such as a collar, tag, or grooming, of being owned; and (b) Exhibits savage or wild behavior or is living in the wild. (14) “Ferret” means Mustela putorius furo. (15) “Livestock” means domestic farm animals, including but not limited to cattle, horses and other equines, swine, sheep, and goats. (16) “Local animal control authority” means that agency or individual appointed by the governing body of a county or the city of Baltimore to oversee animal control. (17) “Local health department” means a county health department under the direction of a local health officer or the Baltimore City Health Department under the direction of the Baltimore City Commissioner of Health. (18) “Local health officer” means the local health officer of a county or the Baltimore City Commissioner of Health, or the designee of the local health officer or the Commissioner of Health. (19) Non-Bite Contact. (a) “Non-bite contact” means a scratch or contamination of an abrasion, open wound, or mucous membrane with saliva or other potentially infectious material from an animal. (b) “Non-bite contact” does not include exposure to non-infectious material such as dried saliva. (20) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind, and any partnership, firm, association, corporation, or other entity. (21) “Provoked” means that bite or non-bite contact from an animal resulted from human activity, such as an individual attempting to play with, pet, feed, handle, hold, harm, or redirect an animal’s actions. (22) “Public Health Veterinarian” means the veterinarian designated by the Secretary as responsible for the Veterinary Public Health Program of the Department or the designee of the Public Health Veterinarian. (23) “Quarantine” means, pursuant to an order of the Public Health Veterinarian or local health officer and on the private premises of the owner or custodian of the animal or at a Department-approved facility, confinement of an animal by leash, an escape-proof enclosure, or another manner, approved in writing by the Public Health Veterinarian or local health officer, that ensures protection of the public health. (24) “Rabies” means an acute viral disease in humans and animals produced by a rhabdovirus belonging to the genus Lyssavirus. (25) “Risk assessment” means the evaluation of the circumstances surrounding a bite or non-bite contact to determine the likelihood that an individual has been exposed to material potentially infectious with rabies. (26) “Secretary” means the Secretary of Health. (27) “Serologic monitoring” means monitoring of a dog or cat that was previously vaccinated against rabies to see if the animal demonstrates sufficient evidence of an immune response within seven days of being vaccinated against rabies. (28) “State Epidemiologist” means the person designated as the State Epidemiologist by the Secretary or the designee of the State Epidemiologist. (29) “Strict quarantine” means that: (a) An animal is confined in an escape-proof enclosure that precludes direct contact with people and other animals; (b) The animal is not removed from the enclosure at any time except for transport in a manner, approved in writing by the local health officer, that will safeguard the public health; (c) Human contact with the animal is restricted to one adult caring for the animal or not allowed at all by the local health officer or Public Health Veterinarian; and (d) The owner or custodian of the animal has signed an agreement with the local health department or animal control authority that the owner or custodian has met and agrees to meet the requirements specified in §B(28)(a)—(c) of this regulation. (30) “Unclaimed stray animal” means a domestic animal that is: (a) Not a feral dog or cat; and (b) Unclaimed by an owner after being held by the local animal control authority at least 72 hours for an owner to claim it. (31) “Wild animal” means a member of a mammalian species that is: (a) Not a domestic animal; (b) A feral dog or cat; or (c) An unclaimed stray animal. #### Regulation .03 Human Rabies. *COMAR 10.06.02.03* A. Reporting. (1) A physician, medical authority, or another person having knowledge of or suspicion of a case of human rabies shall immediately report the facts to the local health officer. (2) A local health officer who has received a report of a case or suspected case of human rabies shall immediately notify, by telephone or other immediate communication medium, the State Epidemiologist or the Public Health Veterinarian of the case or suspected case. B. Isolation. A physician or administrator of a health care facility providing medical care to an individual who is suspected of having been infected with rabies shall isolate the individual in accordance with the order of a local health officer or the State Epidemiologist. C. Immunization; Preexposure. (1) The Department shall provide rabies vaccine free of charge and the local health officer shall provide for the administration of preexposure immunization against rabies for any employee of the Department, a local health department, or another individual who provides rabies control services at the request of the Department. (2) The local health officer may provide rabies preexposure immunization to other individuals who are determined by the Public Health Veterinarian to have a high risk of exposure to rabies infection. (3) The local health officer shall: (a) Report to the Public Health Veterinarian at least every 3 months, the number of preexposure immunizations administered; and (b) Maintain records of the name, address, age, sex, county of residence, occupation, and the results of any blood tests administered in conjunction with rabies preexposure immunization for each individual immunized. (4) The Public Health Veterinarian and the State Epidemiologist shall make and distribute to local health officers recommendations on the dose and schedule of administration of rabies vaccine for the purpose of preexposure immunization of individuals. (5) The local health officer shall administer rabies preexposure immunizations according to the recommendations developed by the Public Health Veterinarian and the State Epidemiologist. D. Treatment; Postexposure. (1) The Public Health Veterinarian and the State Epidemiologist shall jointly issue and distribute to local health departments, physicians, hospitals, and other medical authorities, rabies postexposure treatment guidelines. (2) A local health officer shall report to the Public Health Veterinarian: (a) At least every 3 months, the number of postexposure treatments administered; (b) At the completion of treatment, for each individual administered treatment, the individual’s: (i) Name; (ii) Address; (iii) Age; (iv) Sex; (v) County of residence; and (vi) Occupation; and (c) Other information as directed by the Public Health Veterinarian. (3) The Department shall ensure no one is denied rabies postexposure treatment due to the inability to pay when the treatment is provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist and recommended by a licensed health care provider. (4) The local health officer of the jurisdiction where the resident resides shall ensure access to rabies postexposure treatment provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist. (5) When rabies postexposure treatment is provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist, the Department shall pay the charge of the rabies biologics for persons unable to pay for them: (a) Based on the current ability-to-pay schedule of the Department; and (b) Only after all available benefits and discounts are applied. #### Regulation .04 Animal Rabies. *COMAR 10.06.02.04* A. Reporting. An individual shall report immediately by telephone or in person to the local police, sheriff’s department, or local animal control authority if they know of an animal that: (1) Has rabies; (2) Is suspected of having rabies; or (3) Has had a bite from or non-bite contact with an animal known to have or suspected of having rabies. B. Disposition of a Suspected Rabid Animal — No Bite or Non-Bite Human Contact. (1) Dogs, Cats, and Ferrets. (a) Except as provided in §B(3) of this regulation, the director of a Department-approved facility shall hold in strict quarantine, in a manner and place as established by the local health officer or the Public Health Veterinarian, any dog, cat, or ferret suspected of having rabies that has not had bite or non-bite contact with an individual in the preceding 10 days. (b) Except as provided in §B(3) of this regulation, unless otherwise specified by the Public Health Veterinarian, the director of a Department-approved facility shall continue the strict quarantine of the suspected rabid animal for at least 10 days and maintain proper, humane care of the animal during the period of strict quarantine, after which the animal may be humanely killed or released to its owner or custodian or for adoption. (c) At any time during the strict quarantine period, the local health officer, the Public Health Veterinarian, the owner, or the custodian of the animal may direct that the animal suspected of having rabies be humanely killed for the purpose of rabies testing. (d) At any time during the strict quarantine period, the owner or custodian of the animal may direct that the animal be humanely killed. (e) Rabies testing is not required if there is no human contact or contact with another animal. (2) Livestock. (a) Except as provided in §B(3) of this regulation, the Public Health Veterinarian shall direct the owner or custodian of livestock that has not had bite or non-bite contact with an individual and is suspected of having rabies to hold the livestock in strict quarantine for at least 10 days and shall designate the place and manner in which the strict quarantine is to be carried out, after which the livestock may be humanely killed or released to the owner or custodian. (b) At any time during the strict quarantine period, the local health officer, the Public Health Veterinarian, the owner, or the custodian of the animal may direct that the animal be humanely killed for the purpose of rabies testing. (c) At any time during the strict quarantine period, the owner or custodian of the animal may direct that the animal be humanely killed. (d) Rabies testing is not required if there is no human contact or contact with another animal. (3) Wild Animals. (a) The local health officer or Public Health Veterinarian may order a wild animal that is suspected of having rabies to be humanely killed if there is no evidence that the animal has an individual owner. (b) If there is evidence of ownership, the Public Health Veterinarian, local health officer, or local animal control authority may order the humane killing of the animal if the owner or custodian does not appear within 24 hours to claim the animal or if there is imminent threat to human health or safety. For unclaimed stray animals, the 24-hour period is included within the period required under Regulation .02B(29) of this chapter. (c) If an owner or custodian of the wild animal claims the animal within 24 hours, the Public Health Veterinarian may order the owner to hold the animal in strict quarantine in a place and manner determined by the Public Health Veterinarian for at least 30 days, after which it may be released to the owner or custodian if the animal has not developed rabies. (d) At any time during the strict quarantine period, the local health officer, the Public Health Veterinarian, or the owner or custodian of the animal may direct that the animal be humanely killed for the purpose of rabies testing. C. Examination of Animals Suspected of Having Rabies. (1) The Public Health Veterinarian or the local health officer may order a veterinary examination at any time of an animal suspected of having rabies. (2) The examining veterinarian shall report the results of the examination to the local health officer immediately. (3) The owner or custodian of the animal shall bear the expense of the examination. D. Disposition of an Animal Exposed to a Rabid Animal or to an Animal Suspected of Having Rabies. (1) If the owner or custodian of a domestic animal that has been exposed to a rabid animal, or to an animal suspected of having rabies, is able to provide a current or expired rabies vaccination certificate for the animal, the owner or custodian shall: (a) Have the animal re-vaccinated against rabies immediately; and (b) Keep the animal under the owner or custodian’s control and observed for 45 calendar days or for such time as specified by the Public Health Veterinarian. (2) If the owner or custodian of a domestic animal that has been exposed to a rabid animal, or to an animal suspected of having rabies, is unable to provide a current or expired rabies vaccination certificate: (a) The owner or custodian shall: (i) Have the animal humanely killed; or (ii) Have the animal vaccinated against rabies immediately, and hold dogs and cats in strict quarantine for a minimum of 4 months and other animals in strict quarantine for a minimum of 6 months in a facility and a manner approved by the Public Health Veterinarian; or (b) The local health officer or animal control authority may consult with the Public Health Veterinarian to determine if serologic monitoring can be used to keep a dog or cat under the owner or custodian’s control and observed for 45 calendar days rather than under strict quarantine for 4 months if the owner or custodian of a dog or cat states that the dog or cat was previously vaccinated. (3) The owner or custodian of a domestic animal that is being held in strict quarantine is responsible for all costs related to strict quarantine of the animal. (4) The local health officer, the Public Health Veterinarian, or the local animal control authority may make inspections of the site where an animal is being held in strict quarantine to assure that the animal is being held in strict quarantine under the terms specified in this chapter. (5) The local health officer or the Public Health Veterinarian may order the humane killing for rabies testing of an animal exposed to a rabid animal or to an animal suspected of having rabies if: (a) The strict quarantine agreement defined in Regulation .02B(28) of this chapter is violated; (b) The animal shows signs of having developed rabies; (c) A bite or non-bite contact to a human occurs; (d) A bite or non-bite contact to another animal occurs; (e) The animal is a wild animal; or (f) The exposed animal poses an imminent threat to human health or safety. #### Regulation .05 Reporting Bite or Non-Bite Contacts to Humans. *COMAR 10.06.02.05* A. A person having knowledge of an individual's having a bite from or non-bite contact with an animal shall report the facts of the contact immediately by telephone or in person to the local police or sheriff's department, except in Frederick County, where the person shall report the facts to the animal control center of Frederick County. B. Except as provided at §C of this regulation, upon receipt of a report, the local police or sheriff's department or animal control personnel shall: (1) Complete the Maryland Animal-Bite Report and Rabies Quarantine Agreement Form supplied by the Department, or an equivalent form developed by the local health department; (2) Make the report available within 24 hours to the local health officer and, on request, to the Public Health Veterinarian; and (3) Enforce all orders of the local health officer and the Public Health Veterinarian pursuant to this regulation. C. The local health officer shall report the number of animal bite and non-bite contacts to the Public Health Veterinarian monthly as specified in COMAR 10.06.01. #### Regulation .06 Risk Assessment Following Bite or Non-Bite Contact to Humans. *COMAR 10.06.02.06* Following the report of a bite or non-bite contact to a human, the local health officer shall conduct a risk assessment that includes a determination of: A. The species of animal that made the contact; B. Whether the animal is apparently healthy; C. Whether the animal is adequately vaccinated appropriate to its age; D. The type of contact; E. Whether the bite or non-bite contact was provoked and what human activity may have provoked the bite or non-bite; and F. The reasonable likelihood that the contact animal may have rabies or may have been exposed to rabies within the past 6 months, including information about unsupervised out-of-doors escape episodes, injuries, and other potential contacts of the animal to wild animals or bats. #### Regulation .07 Disposition of Animals Following Bite or Non-Bite Contact to Humans. *COMAR 10.06.02.07* A. When the local health officer has determined that quarantine of the exposing animal is allowable based on the findings of the risk assessment, the animal shall be quarantined. B. Quarantine Period. (1) Dogs, Cats, and Ferrets, Including Unclaimed Stray Animals. Except as provided in §B(3) and (4) of this regulation, the owner or custodian of a dog, cat, or ferret that was involved in bite or non-bite contact with a human shall quarantine the animal in a place and manner approved by the local health officer or the Public Health Veterinarian for at least 10 days after the date of the bite or contact. (2) Livestock Including Unclaimed Stray Animals. Except as provided in §B(3) and (4) of this regulation, the owner or custodian of livestock that has been involved in bite or non-bite contact with an individual shall quarantine the livestock in a place and manner approved by the Public Health Veterinarian in consultation with the Maryland Department of Agriculture for at least 10 days after the date of the bite or contact or a time period specified by the Public Health Veterinarian. (3) Wild Animals. (a) Except in situations in which the local health officer or the Public Health Veterinarian determines that an animal poses an imminent threat to public health or safety and must be killed immediately, the Public Health Veterinarian may order a wild animal involved in bite or non-bite contact with an individual to be placed in quarantine for at least 24 hours. (b) If the animal is not claimed by an owner or custodian within that 24-hour period, the Public Health Veterinarian may order the animal to be humanely killed and its head submitted to the laboratory designated by the Department for rabies testing. (c) For unclaimed stray animals, the 24-hour period is included within the period required under Regulation .02B(29) of this chapter. (4) Wild Animal with a Legal Owner. When a legally owned wild animal has been involved in bite or a non-bite contact with a human, the local health officer, in consultation with the Public Health Veterinarian, shall determine the disposition of the wild animal based on its individual risk assessment. C. Conditions of Quarantine. (1) The Public Health Veterinarian or the local health officer may order the owner or custodian of an animal under quarantine that has had bite or non-bite contact with a human to have the animal examined by a Maryland-licensed veterinarian at any time during the quarantine period. (2) The owner or custodian of an animal under quarantine shall pay for the cost of the veterinary examination and other associated costs. (3) If a Maryland-licensed veterinarian determines that a quarantined animal has possible rabies manifestations, the veterinarian may humanely kill the animal and submit its head promptly through the local health officer or local animal control authority to the laboratory designated by the Department for testing for rabies. D. Limitation on Movement During Quarantine. A person may not move an animal under quarantine from the place of quarantine without the written permission of the local health officer or the Public Health Veterinarian. E. Humane Killing of an Animal for Rabies Testing. The local health officer or the Public Health Veterinarian may order in writing the humane killing of an animal that has had bite or non-bite contact with a human for the purpose of rabies testing if: (1) The local health officer has determined that the contact animal is reasonably likely to have rabies based on the risk assessment; (2) The owner or custodian requests humane destruction during the quarantine; (3) The animal is a wild animal unclaimed for at least 24 hours by an owner or custodian, with, for unclaimed stray animals, the 24-hour period included within the period required under Regulation .02B(29) of this chapter; or (4) The animal is inhumanely suffering. F. Surrender of Animals. A person may not fail or refuse to surrender a dead or live animal for quarantine, humane killing, or rabies testing as required in this chapter when demand is made by written order of the local health officer or the Public Health Veterinarian. G. The police, sheriff, or animal control authority staff shall enforce all written orders of the local health officer or Public Health Veterinarian issued pursuant to this regulation. #### Regulation .08 Area Quarantine. *COMAR 10.06.02.08* A. If rabies is known to exist within an area, the Public Health Veterinarian, in conjunction with the Maryland Department of Agriculture, may establish an area quarantine for rabies, define the boundaries of the quarantine area, and specify the species of animal or animals subject to the quarantine. B. The owner or custodian of an animal subject to the area quarantine shall keep the animal in quarantine on the premises of the owner or custodian at all times until the area quarantine is terminated in writing by the Public Health Veterinarian, in conjunction with the Maryland Department of Agriculture. C. A person may not bring an animal subject to an area quarantine into or out of the quarantine area without the written permission of the Public Health Veterinarian and the Department of Agriculture. #### Regulation .09 Laboratory Testing. *COMAR 10.06.02.09* A. A local health officer or local animal control authority shall submit rabies specimens for laboratory testing. B. The director of the rabies testing laboratory shall promptly forward a copy of the results of a rabies examination to the: (1) Local health officer; (2) Individual that originally submitted the specimen to the laboratory from the local animal control authority; and (3) Public Health Veterinarian. C. The director of the rabies testing laboratory shall promptly report by telephone to the local health officer a positive rabies finding on a specimen from an animal that has been involved in bite or non-bite contact with an individual. D. After receiving results of a positive finding of rabies, the local health officer shall notify the attending physician or attending veterinarian by telephone. #### Regulation .10 Vaccination of Animals. *COMAR 10.06.02.10* A. An owner or custodian of a dog, cat, or ferret shall have that animal adequately vaccinated against rabies by the time the dog, cat, or ferret is 4 months old. B. Vaccination Documentation. (1) Except for a local animal control authority, an owner or custodian of an animal required to be licensed or registered shall have the animal adequately vaccinated and shall obtain a valid rabies vaccination certificate on the form specified by the Department. The certificate shall be completed and signed by a Maryland-licensed veterinarian or, in the case of public antirabies clinics, the certificate may be issued under the authority of the Public Health Veterinarian, documenting that the animal has been adequately vaccinated against rabies for the period of time covered by the rabies vaccination. (2) Except for a kennel licensed by the local animal control authority as a boarding kennel, an owner or operator of a kennel shall present, upon the request of the local health officer, Public Health Veterinarian, or local animal control authority, a valid rabies vaccination certificate for each dog, cat, or ferret: (a) Owned or kept by the kennel; and (b) That is 4 months old or older. (3) The Public Health Veterinarian may delay temporarily or indefinitely the rabies vaccination requirement for certain dogs, cats, or ferrets in the interest of public safety or for medical determinations or research. C. Unless the Public Health Veterinarian has authorized a delay in vaccination, a local animal control authority may not license or register a dog, cat, or ferret without verifying the rabies vaccination status as documented by a current rabies vaccination certificate. D. Vaccination Certificates. (1) A vaccine manufacturer shall issue the official National Association of State Public Health Veterinarians (NASPHV) Form 51, Rabies Vaccination Certificate, or an equivalent form. (2) A veterinarian shall administer rabies vaccine to an animal in accordance with the specifications on the vaccine and recommendations for immunization procedures, such as the current Compendium of Animal Rabies Prevention and Control. (3) The veterinarian administering rabies vaccine to an animal shall: (a) Complete the NASPHV Form 51, or an equivalent form, containing the: (i) Vaccine manufacturer and lot or serial number; (ii) Date the vaccine was given; (iii) Date the next vaccination is due by; (iv) Signature of the veterinarian and the date the rabies certificate was signed; (v) Veterinarian’s name, address, telephone number, and veterinary license number legibly stamped, typed, or printed; (vi) Owner’s name, address, and telephone number; (vii) Rabies tag number; and (viii) Animal’s species, age, weight, predominant breed, and color; and (4) When vaccine is administered at public antirabies clinics, the local clinic staff shall complete the NASPHV Form 51, or an equivalent form, as directed by the Public Health Veterinarian and provide a copy to the local health officer and the animal owner. (5) A veterinarian administering rabies vaccine shall maintain copies of vaccination certificates by tag number for a minimum of 5 years following the vaccination of an animal. (6) An owner or custodian may use the vaccination certificate as proof of vaccination and shall provide it to police, the animal control authority, or health officials upon request. E. Vaccination Procedures. (1) A licensed veterinarian may select a rabies vaccine of the veterinarian’s choice and use procedures for administering it that are consistent with the recommendations of NASPHV, the United States Department of Agriculture, and the Compendium of Animal Rabies Prevention and Control. (2) The Public Health Veterinarian shall select the vaccine or vaccines to be used in public clinics according to Department procedures. (3) The Public Health Veterinarian may require specified lots of vaccine to be tested for potency, safety, and contamination as a prerequisite to their use. (4) Except for veterinary staffing, the public antirabies clinics and the local health officer shall determine all administrative procedures for public antirabies clinics in keeping with the requirements of this chapter. (5) A vendor of rabies vaccine for animal use shall supply vaccine only to a veterinary biologic supply firm, a Maryland-licensed veterinarian, or the Public Health Veterinarian. F. Rabies Tags. (1) The Public Health Veterinarian shall specify annually the size, shape, and color of the rabies tag to be issued by veterinarians and public antirabies clinics. (2) Public antirabies clinics and veterinarians who provide rabies vaccination services to dogs, cats, and ferrets shall promptly issue to the owner of each vaccinated animal a rabies certificate, tag, and s-shaped metal link for attaching the tag on the animal's collar. (3) The local health officer shall order rabies tags through the Public Health Veterinarian for use in public antirabies clinics. G. Antirabies Clinics. (1) In conjunction with the Department, each local health department shall provide for low-cost, self-financing, antirabies clinics for animals in each county and Baltimore City. (2) The Department shall assure that at least two clinics are offered annually with at least one to be held between April 1 and July 1 at dates and locations determined by the local health department. (3) The Public Health Veterinarian shall establish in writing the vaccination procedures to be used at the clinics and distribute these procedures to the local health officers. (4) The local health departments may establish fees sufficient to cover the costs of operating the clinics. (5) The local health officer shall report, in the manner specified by the Public Health Veterinarian, data concerning animals vaccinated at each clinic and the related costs. #### Regulation .11 Importation of Animals. *COMAR 10.06.02.11* A. Except as provided in §§B and I of this regulation, the owner or custodian of a dog, cat, or ferret 4 months old or older to be imported into the State for any purpose shall forward a certificate, issued by a licensed veterinarian, to the Public Health Veterinarian, within 10 days of the animal's arrival in the State, that: (1) Describes the dog, cat, or ferret, documenting that it was vaccinated against rabies; (2) Lists the manufacturer or brand of vaccine used; (3) Lists the date or dates the vaccine was given; (4) Documents that the animal is adequately vaccinated; and (5) Documents that the most recent dose of vaccine was given more than 30 days before the date the animal arrived in the State. B. Except as provided in §I of this regulation, the owner or custodian of a dog, cat, or ferret brought into the State for a period of less than 30 days is exempt from the requirement to forward a certificate to the Public Health Veterinarian as specified in §A of this regulation, if a copy of a certificate signed by a licensed veterinarian can be presented to the local health officer immediately when requested. C. The local animal control authority may accept the certificate specified in §A of this regulation as proof of vaccination for licensing or registration purposes for the period specified on the certificate or 12 months, whichever period is shorter. D. The Public Health Veterinarian or the local health officer may order the owner or custodian of a dog, cat, or ferret brought into Maryland in violation of the provisions of this regulation to return the animal immediately to its point of origin at the owner's expense. E. If the local animal control authority is unable to locate an individual who will assume fiscal responsibility for an animal under an order to be returned to the point of origin within 48 hours of the issuance of the order, the authority may deem the animal abandoned and humanely kill it or place it for adoption. F. Research facilities and licensed dealers, as defined in 7 U.S.C. §2132 and 9 CFR 1.1 and 2.7, are exempt from §§D and E of this regulation when importing dogs, cats, and ferrets. G. The Secretary shall establish, in consultation with the Maryland Department of Agriculture, rabies control requirements for the importing and keeping of animals other than dogs, cats, and ferrets, such as livestock, wildlife, zoo animals, and exotic animals. H. The Secretary, with the agreement of the Secretary of Agriculture and the Secretary of Natural Resources, shall prohibit the importation of certain animals or species of animals from areas inside or outside the United States that are known to have a high prevalence of rabies and the animals subject to the ban are judged to present an unacceptable risk of rabies infection in humans or animals. I. The Public Health Veterinarian may waive the requirements of §§A and B of this regulation if the importation of the animal poses no risk to the public health or safety. #### Regulation .12 Permits Required for Keeping Certain Animals. *COMAR 10.06.02.12* The Secretary shall require a person to obtain from the Public Health Veterinarian a permit for keeping certain animals or species of animals if the Secretary has determined that these animals or species of animals represent a substantial threat of rabies to humans. #### Regulation .13 Disposition of Animals by Animal Shelters, Pounds, or Veterinarians. *COMAR 10.06.02.13* A. The owner or custodian of an animal who surrenders the animal to an animal shelter, pound, or veterinarian for the purpose of having the animal humanely killed or for the purpose of offering the animal for adoption shall certify in writing, under penalty of perjury, that the animal: (1) If a dog, cat, ferret, or livestock, has not had bite or non-bite contact with an individual within the previous 10 days; or (2) If a wild animal, has not had bite or non-bite contact with an individual within the previous 30 days. B. Except as provided in §C of this regulation, if the animal has had bite or non-bite contact with an individual within the time periods specified in §A of this regulation, the animal shelter, pound, or veterinarian shall: (1) If the animal is a dog, cat, ferret, or livestock, offer the owner or custodian, the option of: (a) Quarantining the animal for 10 calendar days at the owner’s or custodian’s expense; or (b) Humanely killing the animal and submitting the head for rabies testing; or (2) If the animal is a wild animal, immediately humanely kill the animal and submit its head for rabies testing. C. The Public Health Veterinarian may waive the requirements of §B of this regulation if it is determined that the public health is not threatened. #### Regulation .14 Penalty. *COMAR 10.06.02.14* A person refusing or failing to comply with the provisions of this chapter, or with the orders or directives of the local health officer, the State Epidemiologist, or the Public Health Veterinarian as provided by this chapter, shall be guilty of a misdemeanor and, upon conviction, subject to a fine of not more than $500 for each offense. ### Chapter 03 — ImmuNet **Authority:** Health-General Article, §18-109; Health Occupations Article, §12-508; Annotated Code of Maryland **Administrative History:** Effective date: April 27, 2015 (42:8 Md. R. 607) #### Regulation .01 Scope. *COMAR 10.06.03.01* This chapter governs ImmuNet, a computer-based registry of immunizations, as established in Health-General Article, §18-109, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.06.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Authorized user” means: (a) A child care facility; (b) A health care provider; (c) A health insurer; (d) A health maintenance organization; (e) An institution of higher learning; (f) A local health department; (g) A long-term care facility; (h) A managed care organization; (i) A nonprofit health service plan; (j) A patient; (k) A pharmacist authorized to administer vaccinations in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland; (l) A school; (m) A school-based health center; (n) In the case of a minor child, a parent or guardian; and (o) Any other authorized user designated by the Secretary. (2) “Department” means the Maryland Department of Health. (3) “ImmuNet” means a computerized information and reminder system to: (a) Improve the timely and appropriate delivery of immunizations; (b) Provide a coordinated network for reminder notices when immunizations are due; (c) Provide and collect information to be shared by authorized users; and (d) Provide a quality indicator for the insurers’ health care provider practices and public health purposes. (4) “Refusal to permit disclosure of information” means the right of an individual or the parent or guardian of a minor to prevent disclosure to authorized users of individual identifiable information that was reported to ImmuNet. (5) Regional Registry. (a) “Regional registry” means a database that contains immunization information for individuals residing in an area of Maryland. (b) “Regional registry” includes an immunization database or registry maintained and operated by a local health department. (6) “Secretary” means the Secretary of Health. (7) “Vaccine information statement (VIS)” means a document that: (a) Is created and updated by the U.S. Centers for Disease Control and Prevention; and (b) Relates: (i) The purpose of specific vaccines; (ii) Schedules of administration; and (iii) Possible adverse reactions to specific vaccines. #### Regulation .03 Administration of ImmuNet. *COMAR 10.06.03.03* A. The Department shall support and administer ImmuNet. B. The Department may enter or edit information contained in ImmuNet. C. ImmuNet is subject to the security and reliability standards set forth in Regulation .09 of this chapter. D. The Department shall make available to authorized users and to the general public all forms relevant to ImmuNet, such as the: (1) User agreement; (2) Refusal to Permit Disclosure of Information form; and (3) Statement of Reactivation of Participation in ImmuNet form. #### Regulation .04 Information Reported to ImmuNet. *COMAR 10.06.03.04* A. The Department shall enter the following information from each birth certificate registered in Maryland: (1) Child’s: (a) First, middle, and last name; (b) Date of birth; (c) Sex; and (d) Current or last known address; and (2) Child’s mother’s: (a) First and middle names; (b) Maiden Name if applicable; and (c) Current last name. B. Following the administration of a vaccine to an individual residing in Maryland, the health care provider who administered the vaccine may enter the following information to ImmuNet: (1) Patient’s: (a) First, middle, and last name; (b) Date of birth; (c) Sex; (d) Birth state and country; (e) Current or last known address; (f) If the patient is a minor, the name of the parent or guardian; (g) Last four digits of Social Security number, if available; and (h) Medicaid number, if available and applicable; (2) Patient’s mother’s: (a) First and middle names; (b) Maiden name, if applicable; and (c) Current last name; (3) For each vaccine administered: (a) Antigen type; (b) Manufacturer; (c) Expiration date; (d) Lot number; (e) Date VIS provided to patient; (f) VIS date; and (g) Date of administration; (4) Contraindication, adverse event, and exemption information for the patient, including: (a) A medical contraindication or adverse event to the administration of one or more vaccines; (b) Whether the contraindication is permanent or temporary and, if temporary, the date after which the contraindication will no longer exist or needs to be reassessed; and (c) An objection to immunization based on a bona fide religious belief and practice; (5) Other medical information pertaining to vaccine-preventable diseases, including serologic test results; (6) Other information designated by the U.S. Centers for Disease Control and Prevention as Immunization Information System Required Core Data Elements; and (7) Other information designated by the Secretary. C. Correction of Inaccurate Information. A patient or a parent or a guardian of a minor patient whose immunization information is entered into ImmuNet may contact the Department to: (1) View the information; and (2) Provide information to correct any inaccuracies. #### Regulation .05 User Agreement. *COMAR 10.06.03.05* A. An authorized user who wishes to obtain information from ImmuNet shall enter into a user agreement with the Department for the purpose of protecting the confidentiality and security of ImmuNet information. B. The user agreement shall include but not be limited to the: (1) Functions that may be performed by an authorized user of ImmuNet; (2) Authorized uses of ImmuNet information as set forth in Health-General Article, §18-109(c), Annotated Code of Maryland; (3) Prohibitive uses of ImmuNet information as set forth in Health-General Article, §18-109(f), Annotated Code of Maryland; and (4) Basic practices for safeguarding confidential information. C. Authorized users shall request the renewal of the user agreement on an annual basis. D. Authorized User Functions. (1) An authorized user who has signed a user agreement may obtain the following information about an individual from ImmuNet: (a) First, middle, and last name; (b) Date of birth; (c) Address; (d) Telephone number; (e) In the case of a minor child, the name of the parent or guardian; (f) Immunizations given; (g) Immunization dates; (h) Contraindication, adverse event, and exemption information; and (i) Other medical information pertaining to vaccine-preventable diseases, including serologic test results. (2) An authorized user that is a health care provider, local health department, long-term care facility, or school-based health center that administers immunizations may: (a) Enter information into ImmuNet directly from medical records that are in the authorized user’s possession; and (b) Edit information the authorized user has entered into ImmuNet. (3) An authorized user who is a patient or a parent or guardian of a minor may view the patient’s or the minor patient’s ImmuNet information without signing a user agreement by requesting the information from the patient’s or minor’s immunization provider or the Department. (4) With approval from the Department, the following authorized users may enter information into ImmuNet: (a) A child care facility; (b) A health insurer; (c) A health maintenance organization; (d) An institution of higher learning; (e) A managed care organization; (f) A nonprofit health service plan; and (g) A school. #### Regulation .06 Refusal and Reactivation. *COMAR 10.06.03.06* A. An individual or a parent or guardian of a minor child who has received an immunization may at any time prohibit information in ImmuNet from being disclosed to authorized users by providing to the Department a signed and dated Refusal to Permit Disclosure of Information form. B. An individual or a parent or guardian of a minor who has submitted a Refusal to Permit Disclosure of Information form may allow information in ImmuNet to be disclosed by submitting to the Department a signed and dated written Statement of Reactivation of Participation in ImmuNet form. #### Regulation .07 Permissible Use of ImmuNet Information. *COMAR 10.06.03.07* Information in ImmuNet may be used by authorized users for the following purposes: A. To provide coordinated immunization services, including sending reminder notices to individuals who need immunizations; B. To obtain an individual immunization history; C. To identify geographic areas or population groups who are underimmunized; D. To compile aggregate information and distribute statistical reports on the status of immunizations in geographic areas and population groups; E. To assist in the management of State and local immunization programs; F. To monitor the safety of vaccines; G. To assess compliance with immunization requirements by monitoring admissions to: (1) Schools; (2) Institutions of higher learning; and (3) Child care facilities; and H. For any other purpose that the Secretary deems necessary to prevent the spread of communicable diseases or assess the safety or effectiveness of vaccines in accordance with Health-General Article, §18-109(c), Annotated Code of Maryland. #### Regulation .08 Regional and Other State Immunization Registries. *COMAR 10.06.03.08* A. A regional registry shall submit to ImmuNet all immunization information on Maryland residents within 14 calendar days of receipt of the information. B. If the confidentiality of records of Maryland citizens is protected, the Department may enter into a collaborative agreement with other states for the purpose of sharing immunization information. #### Regulation .09 Security and Reliability Standards. *COMAR 10.06.03.09* A. The Department shall maintain ImmuNet in accordance with system security requirements for federal information processing systems, including National Institute of Standards and Technology (NIST) 800-53 Special Publication, and prevailing agency information technology security policy standards and requirements. B. ImmuNet Security. (1) The Department shall: (a) Maintain ImmuNet information on a server protected by a firewall; and (b) Encrypt information traveling to and from authorized users. (2) The Department shall maintain encryption keys in a secure location. ### Chapter 04 — School Health Services and Required Immunizations Before Entry into School **Authority:** Education Article, §7-403 and Health-General Article, §18-102(a), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulation .01 amended as an emergency provision effective May 10, 1977 (4:11 Md. R. 865); emergency status extended at 4:22 Md. R. 1667 and 4:27 Md. R. 2095 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .01 amended effective December 16, 1977 (4:26 Md. R. 2024) and May 18, 1979 (6:10 Md. R. 842) **Administrative History:** Regulation .01A amended and C adopted effective February 11, 1985 (12:3 Md. R. 245) **Administrative History:** Regulation .03 amended effective January 2, 1984 (10:26 Md. R. 2340) **Administrative History:** Annotation: COMAR 10.06.04.03 cited in Davis v. State, 294 Md. 370 (1982), in which the court held that “membership in a recognized religious group cannot be required as a condition of exemption from vaccination”. The religious exemption was held to contravene the Establishment Clause of the First Amendment and was therefore invalid. The immunization requirement itself was found to be severable and remains in force. **Administrative History:** Chapter revised effective March 30, 1992 (19:6 Md. R. 672) **Administrative History:** Regulation .03 amended effective April 22, 1996 (23:8 Md. R. 605); May 19, 1997 (24:10 Md. R. 710) **Administrative History:** Regulations .01—.10 repealed and new Regulations .01—.10 adopted effective November 24, 2005 (32:23 Md. R. 1826) **Administrative History:** Regulation .03 amended effective November 12, 2012 (39:22 Md. R. 1428) **Administrative History:** Regulation .03E amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 25, 2006 (33:19 Md. R. 1560) **Administrative History:** Regulation .03F adopted as an emergency provision effective March 20, 2007 (34:8 Md. R. 766); emergency provision expired #### Regulation .01 School Health Services. *COMAR 10.06.04.01* The local health department shall cooperate with the local school system in implementing the School Health Services regulations found in COMAR 13A.05.05.05—15. #### Regulation .02 Definitions. *COMAR 10.06.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Health officer” means the health officer in each of the 23 counties of Maryland and the Commissioner of Health in Baltimore City, the designated representative of the health officer, or both. (2) “Preschool program” means a program that enrolls children in an educational program below the level of kindergarten. (3) “Regulated child care program” means: (a) A family day care provider registered pursuant to COMAR 07.04.01; (b) The operator of a child care center licensed pursuant to COMAR 07.04.02; or (c) The operator of a child care facility issued a letter of compliance pursuant to COMAR 07.04.05. (4) “Secretary” means the Secretary of Health or the Secretary's designee. #### Regulation .03 Required Immunizations. *COMAR 10.06.04.03* A. Except as provided in Regulations .04—.06 of this chapter, a preschool or school principal or other person in charge of a preschool or school, public or private, may not knowingly admit a student to or retain a student in a: (1) Preschool program unless the student's parent or guardian has furnished evidence of age-appropriate immunity against Haemophilus influenzae, type b, and pneumococcal disease; (2) Preschool program or kindergarten through the second grade of school unless the student's parent or guardian has furnished evidence of age-appropriate immunity against pertussis; and (3) Preschool program or kindergarten through the 12th grade unless the student's parent or guardian has furnished evidence of age-appropriate immunity against: (a) Tetanus; (b) Diphtheria; (c) Poliomyelitis; (d) Measles (rubeola); (e) Mumps; (f) Rubella; (g) Hepatitis B; (h) Varicella; (i) Meningitis; and (j) Tetanus-diphtheria-acellular pertussis acquired through a Tetanus-diphtheria-acellular pertussis (Tdap) vaccine. B. Except as provided in Regulations .04—.06 of this chapter, a parent or guardian shall provide evidence of age-appropriate immunity to the preschool or school authority on a form provided by the Secretary or on a printed or computer-generated form that lists the following: (1) Name of the student; (2) Date of birth; (3) Name and address of parent or guardian; (4) Complete history of vaccines received with month, day, and year of each vaccine dose; and (5) Signature, title, and date of the physician, health official, school official, or regulated child care program providing the information on the form. C. Except as provided in Regulations .04—.06 of this chapter and §A(3) of this regulation, a student shall obtain immunizations in accordance with the schedule of immunizations recommended by the Medical and Chirurgical Faculty of Maryland and the Secretary, as set forth in §D of this regulation and as required to be implemented in §§E and F of this regulation. D. Schedule of Immunizations. (1) Student in Preschool. In order for the immunization status of a student enrolled in a preschool to be complete, the student's parent or guardian shall provide proof of the following doses of immunizations: (2) Student in Kindergarten Through 12th Grade. (a) In order for the immunization status of a student enrolled in kindergarten through 12th grade to be complete, the student's parent or guardian shall provide proof of the immunizations or immunity as outlined in §D(2)(b)—(l) of this regulation. (b) Diphtheria. (i) Four doses of diphtheria immunization vaccine are required for a student younger than 7 years old; and (ii) Three doses of diphtheria immunization vaccine are required for a student 7 years old or older. (c) Tetanus. (i) Four doses of tetanus immunization vaccine are required for a student younger than 7 years old; and (ii) Three doses of tetanus immunization vaccine are required for a student 7 years old or older. (d) Pertussis. Four doses of pertussis immunization vaccine are required for a student younger than 7 years old. (e) Poliomyelitis (Oral or Injectable). (i) Three doses of poliomyelitis immunization vaccine are required for a student younger than 18 years old; or (ii) Proof of immunity from poliomyelitis by blood test is required for a student younger than 18 years old. (f) Rubella. (i) Two doses of live rubella virus vaccine are required when the student is 1 year old or older; or (ii) Proof of immunity from rubella by blood test is required when the student is 1 year old or older. (g) Measles (rubeola). (i) Two doses of live measles (rubeola) virus vaccine are required when the student is 1 year old or older; or (ii) Proof of immunity from rubeola by blood test is required when the student is 1 year old or older. (h) Mumps. (i) Two doses of live mumps virus vaccine are required when the student is 1 year old or older; or (ii) Proof of immunity from mumps by blood test is required when the student is 1 year old or older. (i) Hepatitis B. (i) Three doses of hepatitis B vaccine are required; or (ii) Proof of immunity from hepatitis B by blood test is required. (j) Varicella. (i) All doses of varicella vaccine shall be given when the student is 1 year old or older. (ii) Per the schedule of implementation in §E(1) of this regulation and except as provided in §D(2)(j)(iii) of this regulation, one dose of live varicella vaccine is required for a student younger than 13 years old, or two doses of live varicella vaccine are required for a student 13 years old or older, if the student does not have proof of vaccination against varicella at an age younger than 13 years old. (iii) Proof of immunity from varicella by blood test or by medical diagnosis indicated by month and year of diagnosis may be provided instead of meeting the requirements of §D(2)(j)(ii) or (iv) of this regulation. (iv) Per the schedule of implementation in §E(2) of this regulation and except as provided in §D(2)(j)(iii) of this regulation, two doses of live varicella vaccine are required. (k) Meningococcal. One dose of meningococcal vaccine is required per the schedule of implementation in §F of this regulation. (l) Tetanus-diphtheria-acellular pertussis (Tdap). One dose of Tetanus-diphtheria-acellular pertussis (Tdap) immunization vaccine is required per the schedule of implementation in §F of this regulation. (3) Record Review for Student in Preschool Through 12th Grade. A preschool or school, public or private, may count as valid, vaccine doses administered less than or equal to 4 days before the minimum interval or age. E. Schedule of Implementation: Varicella Effective Immunization Dates for a Student in Kindergarten Through 12th Grade. (1) As set forth in §E(2) of this regulation, by the date listed in Column 1, the parent or guardian of a student entering the grade listed in Column 2 shall provide proof to the school that the student: (a) Has received age appropriate vaccination with varicella vaccine; or (b) Is immune to varicella by providing the results of a blood test or a medical diagnosis indicated by month and year of diagnosis. (2) One-Dose Requirement Immunization Dates for a Student in Kindergarten Through 12th Grade. (3) As set forth in §E(4) of this regulation, by the date listed in Column 1, the parent or guardian of a student entering the grade listed in Column 2 shall provide proof to the kindergarten or school that the student: (a) Has received two doses of varicella vaccine; or (b) Is immune to varicella by providing the results of a blood test or a medical diagnosis indicated by month and year of diagnosis. (4) Two-Dose Requirement Immunization Dates for a Student in Kindergarten Through 12th Grade. F. Schedule of Implementation: Meningococcal and Tetanus-diphtheria-acellular pertussis (Tdap) Effective Immunization Dates for a Student in Preschool Through 12th Grade. (1) As set forth in §F(2) of this regulation, by the date listed in Column 1, the parent or guardian of a student entering the grade listed in Column 2 shall provide proof to the preschool or school that the student has received one dose of: (a) Meningococcal immunization vaccine; and (b) Tetanus-diphtheria-acellular pertussis (Tdap) immunization vaccine. (2) Immunization Dates for a Student in 7th Through 12th Grade. #### Regulation .04 Medical Contraindications. *COMAR 10.06.04.04* A. The requirements of Regulation .03 of this chapter do not apply to a student who presents a licensed physician's or health officer's written statement that the student's immunization against a disease in Regulation .03 of this chapter is medically contraindicated. B. The physician or health officer shall indicate in the statement presented under §A of this regulation whether the contraindication is: (1) Permanent; or (2) Temporary. C. If the contraindication is temporary: (1) The physician or health officer shall provide in the statement presented under §A of this regulation an estimate of when the immunization may be obtained by the student; and (2) The student's parent or guardian shall furnish to the preschool or school evidence of the completion of the immunization in accordance with the estimate. D. A preschool or school, public or private, shall maintain a current list of all students enrolled who have an exemption to immunizations on medical grounds. E. Annually, by November 15, a preschool or school, public or private, shall report to the Secretary of Health the number of students with a medical exemption enrolled in all grades. #### Regulation .05 Religious Exemption. *COMAR 10.06.04.05* A. Using the form provided by the Maryland Department of Health, a student whose parent or guardian objects to immunization on the ground that the immunization conflicts with the parent's or guardian's bona fide religious beliefs and practices is exempt from the requirement to present a physician's certificate of immunization in order that the student be admitted to school. B. The exemption allowed under §A of this regulation does not apply when the Secretary declares an emergency or epidemic of disease. C. A preschool or school, public or private, shall maintain a current list of all students enrolled who have an exemption to immunizations on religious grounds. D. Annually, by November 15th, a preschool or school, public or private, shall report to the Secretary of Health the number of students with a religious exemption enrolled in all grades. #### Regulation .06 Temporary Admission or Retention. *COMAR 10.06.04.06* A. Subject to the provisions of §B of this regulation, a preschool or school, public or private, shall temporarily admit a student to or retain a student in a preschool or school if: (1) The student is homeless; or (2) The student's parent or guardian is unable to provide proof of immunization pursuant to the requirements of Regulation .03 of this chapter. B. In order for a student to be temporarily admitted to or retained in a preschool or school, the student's parent or guardian shall present evidence of the student's appointment with a health care provider or local health department to: (1) Receive a required immunization; (2) Reconstruct a lost record; or (3) Acquire evidence of age-appropriate immunity on a form provided by the Department. C. The date of the appointment pursuant to §B of this regulation may not be later than 20 calendar days following the date the student was temporarily admitted or retained. D. A preschool or school, public or private, shall exclude from school a student who has been temporarily admitted or retained on the next school day following the appointment date if the student's parent or guardian fails to provide evidence of required immunizations. #### Regulation .07 Vaccine Provision. *COMAR 10.06.04.07* A. A student may have an immunization administered by the student's personal physician. B. If a parent or guardian cannot obtain the service of a private physician, the parent or guardian of the student may take the student to the local health department for the immunizations. C. A local health department shall provide the immunization referenced in §B of this regulation. #### Regulation .08 Record Review. *COMAR 10.06.04.08* A preschool or school, public or private, shall make immunization records of students available for review by a health officer as needed to assure compliance with regulations or to ascertain the immunization status of students. #### Regulation .09 Report on New Students. *COMAR 10.06.04.09* Annually, by November 15, on a form provided by the Department, a preschool or school, public or private, shall provide the health officer of the jurisdiction where the school is located with an immunization report of students in preschool through 12th grade who are new to the school. #### Regulation .10 Responsible Agencies. *COMAR 10.06.04.10* The local superintendents of schools and the local health officers shall be responsible for carrying out the provisions of this chapter. ### Chapter 05 — Meningococcal Vaccination Requirements for Students in Institutions of Higher Education **Authority:** Health-General Article, §18-102(b), Annotated Code of Maryland **Administrative History:** Effective date: November 12, 2001 (28:22 Md. R. 1937) #### Regulation .01 Scope. *COMAR 10.06.05.01* This chapter applies to meningococcal vaccination of individuals enrolled in institutions of higher education who are living in on-campus student housing. #### Regulation .02 Definitions. *COMAR 10.06.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Enrolled” means having registered for a credit or noncredit course. (2) “Institution of higher education” means a school of post-secondary education that generally limits enrollment to graduates of secondary schools and awards degrees at the associate, baccalaureate, or graduate level. (3) “Meningococcal vaccination” means receipt of the vaccine protecting against at least the four serogroups of A, C, Y, and W-135 of meningococcal disease within the preceding 5 years before the individual moves into on-campus student housing. (4) “On-campus student housing” means housing provided to individuals, regardless of the fee, that is owned, rented, or contracted for and operated by an institution of higher education, or through written agreement, with an agent of the institution of higher education. #### Regulation .03 Required Meningococcal Vaccination. *COMAR 10.06.05.03* Except as provided in Regulation .05 of this chapter, an individual enrolled in an institution of higher education living in on-campus student housing shall: A. Obtain a meningococcal vaccination; and B. Submit written documentation to the institution of higher education from a health care professional or clinic of receipt of a meningococcal vaccination. #### Regulation .04 Notification of Required Meningococcal Vaccination. *COMAR 10.06.05.04* An institution of higher education shall: A. Inform an individual or the parent or guardian of an individual younger than 18 years old of the requirement for meningococcal vaccination at the time the individual: (1) Is accepted for admission to an institution of higher education; or (2) Registers for classes, if the individual is not required to apply for admission before registering for courses; B. Include notice of the requirement for meningococcal vaccination in: (1) Admission acceptance information; (2) Student health-related information and materials; (3) Resident life information and materials; (4) The student handbook; and (5) The college catalog; and C. Provide detailed information to an individual who resides or may reside in on-campus student housing or the parent or guardian of an individual younger than 18 years old who resides or may reside in on-campus student housing concerning: (1) The risks associated with meningococcal disease; and (2) The availability and effectiveness of meningococcal vaccine. #### Regulation .05 Exemption from Meningococcal Vaccination Requirement. *COMAR 10.06.05.05* A. An individual 18 years old or older is exempt from the meningococcal vaccination requirement set forth at Regulation .03 of this chapter if the individual presents to the institution of higher education a signed written waiver as set forth in Regulation .06A of this chapter stating that the individual has: (1) Received and reviewed the information specified in Regulation .04C of this chapter; and (2) Chosen not to obtain the meningococcal vaccination. B. An individual younger than 18 years old is exempt from the meningococcal vaccination requirement set forth at Regulation .03 of this chapter if a signed written waiver as set forth in Regulation .06B of this chapter is presented to the institution of higher education on behalf of the individual stating that a parent or guardian of the individual has: (1) Received and reviewed the information specified in Regulation .04C of this chapter; and (2) Chosen not to have the individual obtain the meningococcal vaccination. #### Regulation .06 Waiver Form. *COMAR 10.06.05.06* A. A waiver form for an individual 18 years old or older shall: (1) State that the individual: (a) Is 18 years old or older; (b) Has received and reviewed the information provided by the institution of higher education on the risk of meningococcal disease and the availability and effectiveness of meningococcal vaccine; and (c) Chooses to waive the receipt of meningococcal vaccine; and (2) Provide spaces for the: (a) Printed name of the individual; (b) Signature of the individual; and (c) Date. B. A waiver form for an individual younger than 18 years old shall: (1) State that: (a) The individual is younger than 18 years old; (b) The parent or guardian of the individual has received and reviewed the information provided by the institution of higher education on the risk of meningococcal disease and the availability and effectiveness of meningococcal vaccine; and (c) The parent or guardian of the individual chooses to waive the receipt of meningococcal vaccine for the individual; and (2) Provide spaces for the: (a) Printed name of the individual; (b) Printed name of the parent or guardian; (c) Signature of the parent or guardian; and (d) Date. #### Regulation .07 Payment for Meningococcal Vaccination. *COMAR 10.06.05.07* Nothing in this chapter shall be construed to require an institution of higher education or a local public health agency to provide or pay for a meningococcal vaccination. ### Chapter 06 — Communicable Disease Prevention — Handling, Treatment, and Disposal of Special Medical Waste **Authority:** Health-General Article, §18-102, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.08 adopted as an emergency provision effective September 30, 1988 (15:22 Md. R. 2547); emergency status expired March 29, 1989; adopted permanently effective May 1, 1989 (16:8 Md. R. 909) **Administrative History:** Regulation .02B amended effective December 20, 1993 (20:25 Md. R. 1947) **Administrative History:** Regulation .04B amended effective December 20, 1993 (20:25 Md. R. 1947) **Administrative History:** Regulation .06B amended effective December 20, 1993 (20:25 Md. R. 1947) **Administrative History:** Regulation .07C amended effective December 20, 1993 (20:25 Md. R. 1947) **Administrative History:** Regulations .01—.07 repealed and new Regulations .01—.07 adopted effective September 1, 2004 (31:16 Md. R. 1254) **Administrative History:** Regulation .02B amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .04 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .06A amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732) #### Regulation .01 Scope and Purpose. *COMAR 10.06.06.01* A. Scope. (1) Regulations .01—.03 apply to a person who generates and handles special medical waste or sharps. (2) Regulations .01—.07 apply to a person who treats and disposes of special medical waste. (3) This chapter does not apply to: (a) Waste generated from veterinary practices that is governed by COMAR 15.14.03.02; (b) Radioactive medical waste that is governed by COMAR 26.12.01.01; (c) Remains of a dead human; and (d) Fetuses and placentas that are released to a funeral director or a parent. B. Purpose. The purpose of this chapter is to minimize the possibility of disease transmission by establishing requirements for the handling, treatment, and disposal of special medical waste. #### Regulation .02 Definitions. *COMAR 10.06.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Anatomical material” means human or animal body parts, including tissues and organs. (2) “Autoclaving” means a process by which an article is subjected to steam under pressure for documented periods of time, temperature, and pressure that render the article incapable of transmitting disease to humans. (3) “Blood” means human blood, human blood components, and products made from human blood. (4) Bloodborne Pathogens. (a) “Bloodborne pathogens” means pathogenic microorganisms that: (i) Are present in human blood; and (ii) Can cause disease in humans. (b) “Bloodborne pathogens” includes, but is not limited to: (i) Human immunodeficiency virus; (ii) Hepatitis B virus; and (iii) Hepatitis C virus. (5) “Chemical disinfection” means the application of a chemical agent to an article, so that the article is rendered incapable of transmitting disease to humans. (6) “Contaminated” means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. (7) “Cremation” means the incineration of human or animal remains. (8) “Decontamination” means the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on an article to render the article incapable of transmitting disease to humans. (9) “Department” means the Maryland Department of Health. (10) “Disinfection” means a method that inactivates: (a) Vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 log reduction or greater; and (b) Bacillus stearothermophilus spores and Bacillus subtilis spores at a 4 log reduction or greater. (11) “Encapsulation” means a process by which: (a) An article is sealed in a material that renders the article no longer recognizable or capable of transmitting disease to humans; and (b) The sealed material: (i) Is decontaminated or disinfected during the encapsulation process; and (ii) Remains sealed under physical stress. (12) “Incineration” means a process during which an article is burned: (a) In an incinerator that meets the requirements of the Department of the Environment as set forth in COMAR 26.11.08; (b) To carbonized or mineralized ash that is capable of disposal as solid waste; and (c) So the article is rendered incapable of transmitting disease to humans. (13) “Infectious agent” means an organism, including viral, rickettsial, bacterial, fungal, protozoal, or helminthic, that is capable of producing infection or infectious disease in humans. (14) “Interment” means burial in a location, other than a landfill, that is approved for that purpose under applicable law. (15) “Mechanical destruction” means a physical process that renders an article no longer recognizable as the original article. (16) “Microbiological laboratory waste” means waste from a microbiological laboratory that: (a) Contains an infectious agent; and (b) Includes cultures and stocks of infectious agents and associated biologicals. (17) “Occupational exposure” means skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials, that results from the performance of an employee's duties. (18) “Other potentially infectious material” means: (a) The following human body fluids: (i) Amniotic fluid; (ii) A body fluid that is visibly contaminated with blood; (iii) A body fluid that cannot be readily identified; (iv) Cerebrospinal fluid; (v) Pericardial fluid; (vi) Peritoneal fluid; (vii) Pleural fluid; (viii) Saliva only when dental procedures are performed; (ix) Semen; (x) Synovial fluid; and (xi) Vaginal secretions; (b) A tissue or organ from a living or dead human, not including intact skin, that has not been preserved by a chemical additive or preservative; (c) The following human immunodeficiency virus, hepatitis B virus, or hepatitis C virus related items: (i) HIV containing cell, tissue, or organ cultures; (ii) HIV, Hepatitis B, or Hepatitis C containing media or other solutions; and (iii) Blood, organs, or other tissues; and (d) Microbiological laboratory waste. (19) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (20) “Sanitary sewer” means: (a) A liquid waste piping network leading to a sewerage system permitted under Environment Article, §9-204, Annotated Code of Maryland; or (b) An on-site sewerage system permitted under Environment Article, §9-204, Annotated Code of Maryland. (21) “Sharps” means an object contaminated by blood or other potentially infectious material that can cut or penetrate the skin, including but not limited to: (a) A broken capillary tube; (b) Broken glass; (c) An exposed end of dental wire; (d) A needle; (e) A surgical instrument; and (f) A syringe with an attached sharp. (22) “Special medical waste” means: (a) Liquid or semiliquid blood or another potentially infectious material; (b) A contaminated article that releases liquid or semiliquid blood or another potentially infectious material if compressed; (c) An article that contains dried blood or another potentially infectious material and is capable of releasing the blood or material during handling; (d) Pathological and microbiological waste containing blood or another potentially infectious material; (e) Contaminated sharps; and (f) Anatomical material. #### Regulation .03 Handling of Special Medical Waste. *COMAR 10.06.06.03* A person shall handle special medical waste in accordance with the requirements of: A. 29 CFR §1910.1030(d)(4)(iii)(A) and (B), which is incorporated by reference at COMAR 09.12.31; and B. COMAR 26.13.12.05 and 26.13.13. #### Regulation .04 Treatment of Special Medical Waste, Excluding Sharps, Before Disposal. *COMAR 10.06.06.04* A. Except as provided in §B of this regulation, a person shall: (1) Treat special medical waste, excluding sharps, before disposal; and (2) Use one of the following treatment methods: (a) Autoclaving; (b) Chemical disinfection; (c) Cremation; (d) Disinfection; (e) Mechanical destruction after decontamination; (f) Incineration; or (g) An alternative method that meets the criteria of Regulation .06 of this chapter. B. A person may discharge certain special medical waste directly into a sewerage system, without treatment, in accordance with Regulation.07B of this chapter. #### Regulation .05 Treatment of Sharps Before Disposal. *COMAR 10.06.06.05* A person shall treat sharps: A. Before disposal; and B. By one of the following methods: (1) Encapsulation; (2) Incineration; (3) Mechanical destruction after decontamination; or (4) An alternative method that meets the criteria of Regulation .06 of this chapter. #### Regulation .06 Alternative Treatment Systems. *COMAR 10.06.06.06* A. Except as provided in §B of this regulation, a person may not use a method for treatment of special medical waste other than those set forth at Regulations .04A(2) and .05B of this chapter. B. Criteria for Alternative Treatment System. A person may use a method for treatment of special medical waste that complies with the following standards for treatment and microbial test procedures: (1) The method inactivates vegetative bacteria, fungi, parasites, lipophilic or hydrophilic viruses, and mycobacteria at a 6 log reduction or greater; (2) The method inactivates bacterial spores at a 4 log reduction or greater; and (3) The tests have been performed on a representative from each of the following microbial groups: (a) Staphylococcus aureus (ATCC 6538) or Pseudomonas aeruginosa (ATCC 15422); (b) Candida albicans (ATCC 18804) or Penicillium chrysogenum (ATCC 24791); (c) Polio 2 or Polio 3 or MS-2 Bacteriophage, (ATCC 15597-B1); (d) Cryptosporidium spp. oocysts or Giardia spp. cysts; (e) Mycobacterium terrae, Mycobacterium phlei, or Mycobacterium bovis (BCG) (ATCC 35743); and (f) Bacillus stearothermophilus (ATCC 7953) or Bacillus subtilis (ATCC 19659). C. A person may not use a method for treating of special medical waste that: (1) Creates a threat to health or safety; or (2) Violates applicable federal and State environmental laws or regulations. #### Regulation .07 Disposal of Special Medical Waste. *COMAR 10.06.06.07* A. Subject to §§B and C of this regulation, a person shall dispose of special medical waste after treatment by one of the following methods: (1) Interment; (2) Depositing in a facility approved to accept the type of solid waste being disposed in accordance with §C of this regulation; or (3) Incineration. B. A person may discharge a special medical waste that is liquid, semiliquid, or anatomical material that has been mechanically destroyed into a sewerage system, if the discharge is allowed under: (1) Local ordinance or regulation; and (2) Environment Article, Title 9, Annotated Code of Maryland. C. A person shall dispose of special medical waste in accordance with: (1) State laws and regulations pertaining to solid waste disposal including Environment Article, Title 9, Annotated Code of Maryland; and (2) Local ordinances and regulations to the extent that the local requirements are not preempted by or in conflict with State law. #### Regulation .08 Enforcement. *COMAR 10.06.06.08* A. The Secretary may enter the property of any person who generates, handles, treats, or disposes of special medical waste to investigate a complaint the Secretary receives regarding the handling, treatment, or disposal of special medical waste. B. Criminal Penalties. (1) A person who violates these regulations is guilty of a misdemeanor, and on conviction is subject to a fine not exceeding $500. (2) Each day that a violation exists shall constitute a separate offense. C. In addition to any penalty under §B, if a person violates these regulations, the Secretary may suspend or revoke any license, permit, or certificate issued to the person under the Health-General Article, Annotated Code of Maryland. ### Chapter 07 — Sexually Transmitted Infections — Expedited Partner Therapy for Chlamydia, Gonorrhea, and Trichomoniasis **Authority:** Health-General Article, §§2-104(b), 18-102, 18-201, 18-202, and 18-214.1, Annotated Code of Maryland **Administrative History:** Effective date: March 28, 2016 (43:6 Md. R. 406) **Administrative History:** Regulation .01A amended effective March 26, 2018 (45:6 Md. R. 318) **Administrative History:** Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 318) **Administrative History:** Regulation .04-1 adopted effective March 26, 2018 (45:6 Md. R. 318) **Administrative History:** Regulation .05A, B amended effective March 26, 2018 (45:6 Md. R. 318) **Administrative History:** Regulation .06C amended effective March 26, 2018 (45:6 Md. R. 318) #### Regulation .01 Purpose and Scope. *COMAR 10.06.07.01* A. The purpose of expedited partner therapy in Maryland is to: (1) Provide antibiotic therapy to any partner of a patient diagnosed with chlamydia, gonorrhea, or trichomoniasis without a personal physical assessment of the partner, and without having a previous provider-patient relationship with the partner; (2) Contain and stop the further spread of chlamydia, gonorrhea, and trichomoniasis; and (3) Reduce the likelihood of reinfection in the diagnosed patient. B. This chapter applies to the provision of expedited partner therapy, as described in §A of this regulation, in public and private health care settings. #### Regulation .02 Definitions. *COMAR 10.06.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Antibiotic therapy” means the oral antibiotic treatment regimens: (a) Currently recommended by the Centers for Disease Control and Prevention for the treatment of chlamydia and gonorrhea through expedited partner therapy; and (b) For the treatment of trichomoniasis through expedited partner therapy: (i) In accordance with Regulation .05A of this chapter; and (ii) As authorized by Health-General Article, §18-214.1, Annotated Code of Maryland. (2) “Department” means the Maryland Department of Health. (3) “Expedited partner therapy (EPT)” means the prescribing or dispensing of antibiotic therapy to any partner of a patient diagnosed with chlamydia, gonorrhea, or trichomoniasis by certain health care providers without making a personal physical assessment of the partner, and without having a previous provider-patient relationship with the partner, in order to contain and stop the further spread of the infection and reduce the likelihood of reinfection in the diagnosed patient. (4) “Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City, or the duly designated representative of the health officer, or both. (5) “Partner” means an individual with whom one has, or has had, oral, anal or vaginal sexual contact. #### Regulation .03 Partners Eligible for EPT. *COMAR 10.06.07.03* Partners eligible for EPT are: A. Any partner within 60 calendar days of the patient’s diagnosis; or B. The most recent partner of a patient if the patient has not had sex in the 60 days before diagnosis. #### Regulation .04 Health Care Providers Authorized to Prescribe and Dispense EPT. *COMAR 10.06.07.04* Notwithstanding any other provision of law, and only in accordance with their current scope of practice, EPT may be prescribed or dispensed by the following health care providers: A. A physician licensed under Health Occupations Article, Title 14, Annotated Code of Maryland; B. An authorized physician assistant licensed under Health Occupations Article, Title 15, Annotated Code of Maryland, acting in accordance with Health Occupations Article, §15-302.2, Annotated Code of Maryland; C. An advanced practice registered nurse with prescriptive authority licensed under Health Occupations Article, Title 8, Annotated Code of Maryland, acting in accordance with Health Occupations Article, §8–508, Annotated Code of Maryland; and D. A registered nurse employed by a local health department who complies with: (1) The formulary developed and approved under Health-General Article, §3-403(b), Annotated Code of Maryland; and (2) The requirements established under Health Occupations Article, §8-512, Annotated Code of Maryland. #### Regulation .04-1 Pharmacists Authorized to Dispense EPT. *COMAR 10.06.07.04-1* Notwithstanding any other provision of law, a pharmacist licensed under Health Occupations Article, Title 12, Annotated Code of Maryland, may dispense antibiotic therapy for EPT prescribed in accordance with Regulation .04 of this chapter. #### Regulation .05 Prescribing and Dispensing EPT Medications. *COMAR 10.06.07.05* A. Antibiotic therapy prescribed or dispensed for EPT shall be in accordance with treatment recommendations from the Centers for Disease Control and Prevention. B. Prescribing. (1) A separate prescription shall be issued for each partner. (2) The designation “EPT” or “Expedited Partner Therapy” shall be included on the face of the prescription for each prescription issued. (3) If the partner’s name is known, the prescription shall be issued in the partner’s name. (4) If the partner’s name is unknown, the written designation “EPT” or “expedited partner therapy” shall be sufficient for the pharmacist to fill the prescription. (5) An EPT prescription may not be refilled. C. Dispensing. Each EPT medication label shall: (1) Include: (a) The designation “EPT” or “Expedited Partner Therapy”; and (b) The partner’s name, if known; and (2) Comply with Health Occupations Article, §12-505, Annotated Code of Maryland. #### Regulation .06 Counseling and Educational Information Requirements. *COMAR 10.06.07.06* A. A health care provider prescribing or dispensing EPT to a patient shall: (1) Counsel the patient to encourage each partner to seek a personal physical assessment; and (2) Provide the patient with educational information for each partner, in accordance with §C of this regulation. B. A pharmacist dispensing EPT shall provide educational information for each partner, in accordance with §C of this regulation. C. The educational information, that is available or comparable to that available on the Department’s website, shall include: (1) Advice for the partner to seek a medical evaluation; (2) Information about chlamydia, gonorrhea, and trichomoniasis; (3) Medication instructions; (4) Warnings about adverse drug or allergic reactions; and (5) Advice to abstain from sexual activity as required during treatment. #### Regulation .07 Documenting EPT in a Medical Chart. *COMAR 10.06.07.07* A. A health care provider prescribing or dispensing EPT shall document the provision of EPT in the patient’s chart. B. Documentation shall include the: (1) Number of EPT prescriptions or medications provided to the patient for each partner; and (2) Medication and dosage being provided to the patient for each partner. #### Regulation .08 Reporting of Chlamydia and Gonorrhea by a Health Care Provider or Institution. *COMAR 10.06.07.08* A. This chapter may not affect the obligation of a health care provider or institution to report to a health officer cases of chlamydia and gonorrhea and the treatment provided to those cases in accordance with COMAR 10.06.01.04. B. When reporting a case of chlamydia or gonorrhea for which EPT was prescribed or dispensed, a health care provider or institution shall report the number of partners for whom: (1) Prescriptions were provided; and (2) Medications were dispensed. ## Subtitle 07 — Hospitals ### Chapter 01 — Acute General Hospitals and Special Hospitals **Authority:** Health-General Article, §§19-307.2, 19-308, 19-308.6, 19-308.8, 19-318—19-320, 19-323, 19-342, 19-349.1, and 19-380—19-385; Insurance Article, Title 4, Subtitle 4; Public Safety Article, §14-110.1; Annotated Code of Maryland **Administrative History:** Effective date: December 19, 1946 **Administrative History:** Amended effective March 20, 1959 **Administrative History:** Amended effective September 1, 1964 **Administrative History:** Regulations .03C, G, I, K; .04B, D; .05A, B; .06C; .07B, E; .08A, B; .09B, C; .10F; .11A, B; .12F amended effective February 24, 1978 (5:4 Md. R. 226) **Administrative History:** Regulations .01—.13 repealed and new Regulations .01—.10 adopted effective August 1, 1983 (10:15 Md. R. 1350) **Administrative History:** Regulation .01 amended as an emergency provision effective August 12, 1985 (12:18 Md. R. 1756), emergency status expired December 10, 1985; adopted permanently effective December 16, 1985 (12:25 Md. R. 2471) **Administrative History:** Regulation .01 amended effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulations .01, .02B, .04A, .05A, .07, .08B amended; .02C, .09D, and new .10 and .11 adopted; existing .10—.20 recodified as .12—.22 as an emergency provision effective July 1, 1986 (13:15 Md. R. 1726); adopted permanently effective December 1, 1986 (13:24 Md. R. 2558) **Administrative History:** Regulation .01B amended effective December 28, 1987 (14:26 Md. R. 2746); August 6, 1990 (17:15 Md. R. 1858) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); amended permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Regulation .01B amended effective November 11, 2002 (29:22 Md. R. 1721); April 21, 2008 (35:8 Md. R. 804); June 28, 2010 (37:13 Md. R. 852); April 16, 2012 (39:7 Md. R. 491); March 31, 2014 (41:6 Md. R. 378); March 27, 2017 (44:6 Md. R. 325); April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .02 recodified to be Regulation .03 and new Regulation .02 adopted effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .02 amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .02D adopted effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .02D repealed effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .03 repealed and Regulation .02 recodified to be Regulation .03 effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .03 amended effective June 24, 1991 (18:12 Md. R. 1338) **Administrative History:** Regulation .03A amended effective November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .04 amended effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .04A amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .04A, C amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .04D amended effective February 26, 2007 (34:4 Md. R. 400) **Administrative History:** Regulation .05 amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .05A amended effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .06A amended as an emergency provision effective November 20, 2019 (46:26 Md. R. 1162); emergency status expired May 18, 2020 **Administrative History:** Regulation .06C adopted as an emergency provision effective November 20, 2019 (46:26 Md. R. 1162); emergency status expired May 18, 2020 **Administrative History:** Regulation .06-1 adopted as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); adopted permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Regulation .07 amended effective December 28, 1987 (14:26 Md. R. 2746); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .07A amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .08 amended effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .08B adopted effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .08B amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .09 amended effective June 24, 1991 (18:12 Md. R. 1338); November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .09A amended effective February 26, 2007 (34:4 Md. R. 400); March 31, 2014 (41:6 Md. R. 378); April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .10A amended effective June 24, 1991 (18:12 Md. R. 1338); November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulations .11—.20 adopted as an emergency provision effective August 12, 1985 (12:18 Md. R. 1756), emergency status expired December 10, 1985; adopted permanently effective December 16, 1985 (12:25 Md. R. 2471) **Administrative History:** Regulation .13 amended effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .20 amended effective December 28, 1987 (14:26 Md. R. 2746) **Administrative History:** Regulation .21 repealed effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .22 repealed effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .22 adopted effective April 16, 2012 (39:7 Md. R. 491) **Administrative History:** Regulation .23 adopted effective February 22, 1988 (15:4 Md. R. 473) **Administrative History:** Regulation .23A and C amended as an emergency provision effective June 9, 1988 (15:14 Md. R. 1653); emergency status expired December 9, 1988; adopted permanently effective December 26, 1988 (15:26 Md. R. 2982) **Administrative History:** Regulations .24—.26 adopted effective December 28, 1987 (14:26 Md. R. 2746) **Administrative History:** Regulation .24 amended effective March 1, 2004 (31:4 Md. R. 315); March 31, 2014 (41:6 Md. R. 378) **Administrative History:** Regulation .24C amended as an emergency provision effective May 6, 2025 (52:11 Md. R. 531); adopted permanently effective October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .24E amended effective April 16, 2012 (39:7 Md. R. 491) **Administrative History:** Regulation .25 repealed effective March 15, 2004 (31:5 Md. R. 448) **Administrative History:** Regulation .25 adopted effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .26 recodified to Regulation .27, and new Regulation .26 adopted effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .26 amended effective April 2, 1990 (17:6 Md. R. 741) **Administrative History:** Regulations .27—.31 adopted effective August 6, 1990 (17:15 Md. R. 1858) **Administrative History:** Regulation .27 recodified to Regulation .32 effective August 6, 1990 (17:15 Md. R. 1858) **Administrative History:** Regulations .27—.31 repealed effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .27 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .28 adopted effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .28A amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .29 adopted effective March 31, 2014 (41:6 Md. R. 378) **Administrative History:** Regulation .29F adopted effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .30 adopted effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .30A amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .31 adopted effective March 27, 2017 (44:6 Md. R. 325) **Administrative History:** Regulation .32D amended effective November 11, 2002 (29:22 Md. R. 1721); June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Regulation .32-1 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .32-2 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .32-3 adopted effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .33 adopted effective November 11, 2002 (29:22 Md. R. 1721) **Administrative History:** Regulation .33A amended effective March 2, 2015 (42:4 Md. R. 433) **Administrative History:** Regulation .34 adopted effective April 21, 2008 (35:8 Md. R. 804) **Administrative History:** Regulation .35 adopted effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .36 adopted effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .37 adopted effective April 23, 2018 (45:8 Md. R. 420) #### Regulation .01 Definitions. *COMAR 10.07.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited hospital” means a hospital accredited by The Joint Commission or other accreditation organization approved by the Department. (2) “Accredited special rehabilitation hospital” means a hospital that is accredited by the Commission on Accreditation of Rehabilitation Facilities for providing comprehensive physical rehabilitation services. (2-1) “Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities based on nationally recognized and developed standards. (3) “Administrative day” means a day of care rendered to a patient who no longer requires the level of care the hospital is licensed to provide. (4) “Admission” means the formal acceptance by a hospital of a patient who is to be provided with room, board, and medical services. (4-1) Aftercare. (a) “Aftercare” means any assistance provided by a lay caregiver to a patient after discharge of the patient. (b) “Aftercare” includes tasks that are limited to the patient’s condition at the time of discharge that do not require a licensed professional. (5) “Agent” means the individual or individuals, or organization that shall conduct utilization review activities in fulfillment of a hospital's responsibilities under these regulations. The agent may be a hospital employee or employees, or it may be an independent group or organization. (6) “Appointment” means designation of a physician to have staff privileges at the hospital. (7) “Authorized decision maker” means the health care agent, guardian of the person, or surrogate decision maker who is making health care decisions on behalf of a patient in accordance with the Health Care Decisions Act, Health-General Article, §§5-601—5-618, Annotated Code of Maryland. (8) “Calculated licensed bed capacity” means the total number of inpatient beds recalculated annually as 140 percent of a general hospital's average daily census as determined by the Health Services Cost Review Commission for the most recent 12-month period. (9) “Claim” means a written demand for damages as a result of alleged professional malpractice. (10) “Commission on Accreditation of Rehabilitation Facilities” means the private, nonprofit organization formed in 1966 which has established standards of quality for rehabilitation services and accredits those who provide the services. (11) “Comprehensive physical rehabilitation services” has the same meaning as defined in Health-General Article, §19-1201(b), Annotated Code of Maryland. (12) “Credentialing process” means the process by which a hospital: (a) Verifies qualifications of a physician; (b) Delineates clinical privileges of a physician; and (c) Monitors performance of a physician. (13) “Department” means the Maryland Department of Health. (14) “Elective”, when applied to admission or to a health care service, means an admission or service that can be delayed without substantial risk to the health of the individual. (15) “Healthcare-associated infection” means an infection that: (a) Develops in a patient who is cared for in any setting where healthcare is delivered; and (b) Was not incubating or present at the time the healthcare was provided. (16) “Hospital” means an institution that: (a) Has a group of at least five physicians who are organized as a medical staff for the institution; (b) Maintains facilities to provide, under the supervision of the medical staff, diagnostic and treatment services for two or more unrelated individuals; and (c) Admits or retains the individuals for overnight care. (17) “Incident” means any circumstance or occurrence that may be injurious to a patient or that may result in an adverse outcome to a patient. (18) “The Joint Commission” means the voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97 and for Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland. (18-1) “Lay caregiver” means an individual who: (a) Is an adult; (b) Is designated as a lay caregiver by a patient or the legal guardian of a patient; and (c) Performs aftercare for the patient at the residence of the patient. (19) “License” means a license issued by the Secretary to operate a hospital in this State. (20) “Long-term care” means, for the purpose of this chapter, care provided in a hospital, but is designed to treat conditions requiring treatment at a level below that of acute hospital care. (21) “Maryland Medical Assistance Program” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons. For the purpose of this chapter, this shall include those persons provided care under the program administered and financed by the State for eligible needy persons who do not meet the technical requirements of federally funded Medical Assistance. (22) “Medical Orders for Life Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland. (23) “Medicare Program” means the federal program of health insurance for the aged and disabled established pursuant to 42 U.S.C. §1395 et seq. (24) “Nonaccredited hospital” means a: (a) Hospital not accredited by The Joint Commission or other accreditation organization approved by the Department; or (b) Special rehabilitation hospital not accredited by The Joint Commission. (25) “Nonelective”, when applied to admission or to a health care service, means an admission or service that cannot be delayed without substantial risk to the health of the individual. (26) “Palliative care” means specialized medical care for individuals with serious illnesses or conditions that: (a) Is focused on providing patients with relief from the symptoms, pain, and stress of a serious illness or condition, whatever the diagnosis; (b) Has the goal of improving quality of life for the patient, the patient’s family, and other caregivers; (c) Is provided at any age and at any stage in a serious illness or condition; and (d) Can be provided along with curative treatment. (27) “Palliative care program” means an interdisciplinary team that provides palliative care services. (28) “Physician” has the meaning stated under Health Occupations Article, §14-101(j), Annotated Code of Maryland. (29) “Plan” means a thorough written specification of how the elements of review required by these regulations shall be performed. (30) “Privilege” means the authority granted to a physician by a hospital to: (a) Admit patients to the hospital; or (b) Perform specific procedures or treatments on patients at the hospital. (30-1) Residence. (a) “Residence” means a dwelling that a patient considers to be home. (b) “Residence” does not include: (i) A rehabilitation facility; (ii) A hospital; (iii) A nursing home; (iv) An assisted living; or (v) A group home licensed by the State. (31) “Secretary” means the Secretary of Health. (32) “Specialized rehabilitation program” has the meaning stated in Health-General Article, §19-1201(e), Annotated Code of Maryland. (33) Telemedicine. (a) “Telemedicine” means the use of interactive audio, video, or other telecommunications or electronic technology by a physician in the practice of medicine outside the physical presence of the patient. (b) “Telemedicine” does not include: (i) An audio only telephone conversation between the physician and patient; (ii) An electronic mail message between a physician and a patient; or (iii) A facsimile transmission between a physician and a patient. (34) “Unexpected adverse outcomes” means unanticipated negative outcomes related to a patient’s medical treatment and not related to the natural course of the patient’s illness or underlying disease condition. (35) “Uniform standard credentialing form” means: (a) The form designated by the Department through COMAR 10.07.01.24C(6) for credentialing physicians who seek to be employed by or have staff privileges at a hospital; or (b) The uniform credentialing form that the Insurance Commissioner designates under Insurance Article, §15–112.1, Annotated Code of Maryland. (36) “Utilization review” means a system for reviewing the appropriate and efficient allocation of hospital resources and services given or proposed to be given to a patient or group of patients. (37) “Utilization review plan” means a description of the standards governing utilization review activities performed by a private review agent or hospital utilization review agent. #### Regulation .02 Incorporation by Reference. *COMAR 10.07.01.02* The following documents are incorporated by reference: A. Guidelines for Design and Construction of Hospitals, The Facilities Guidelines Institute (2022 Edition); and B. 2025 Hospital Accreditation Standards, Elements of Performance, The Joint Commission, (December 15, 2024). #### Regulation .03 Hospital Classification. *COMAR 10.07.01.03* A. General Hospital. A hospital shall be classified as a general hospital if the hospital at least has the facilities and provides the services that are necessary for the general medical and surgical care of patients. B. Special Hospital. A hospital shall be classified as a special hospital if the hospital: (1) Defines a program of specialized services, such as obstetrics, mental health, tuberculosis, orthopedy, chronic disease, or communicable disease; (2) Admits only patients with medical or surgical needs within the program; and (3) Has the facilities for and provides those specialized services. C. Special Rehabilitation Hospital. A hospital shall be classified as a special rehabilitation hospital if the hospital provides or holds itself out as providing comprehensive physical rehabilitation services. #### Regulation .04 Licensure Application Procedure. *COMAR 10.07.01.04* A. A person desiring to open a hospital, to continue the operation of an existing hospital, or to change the classification of an existing hospital shall file an application with the Secretary, on a written or electronic form provided by the Secretary. An application shall state the classification of hospital for which a license is sought. B. Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency and names of their Board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee's. The names of persons holding 2 percent or more of the stock or assets shall be disclosed. C. License Renewal. An application for the renewal of the license on a written or electronic form provided by the Secretary shall be made: (1) By a nonaccredited hospital at least 60 days before expiration of the issued license; or (2) By an accredited hospital within 30 calendar days of the exit date of the triennial survey conducted by an accreditation organization approved by the Department. D. License Fees. (1) All applications shall be accompanied by the fee established by the Secretary. (2) Accredited hospitals shall submit a $3,000 nonrefundable license fee per accreditation period, payable to the Department. (3) Nonaccredited hospitals shall submit a $1,000 nonrefundable annual license fee, payable to the Department. E. In order to ensure that the hospital's licensure information is current, the hospital shall immediately notify the Department in writing of any change in the hospital's: (1) Name; (2) Administrator; or (3) Contact information such as mailing address and telephone number. F. In order to ensure the completion of any review or inspection by the Department of any major renovations, construction of patient care areas, or the establishment of a medical service as defined under Health-General Article, §19-120, Annotated Code of Maryland, and not previously provided by the hospital, the hospital shall notify the Department 60 days before its occupancy or operation. #### Regulation .05 Duration of License. *COMAR 10.07.01.05* A. The Secretary shall issue a license to an accredited hospital or special rehabilitation hospital for the term of the facility's accreditation. B. The Secretary shall issue a license to a nonaccredited hospital for a term not to exceed 1 year. #### Regulation .06 Separate License Required. *COMAR 10.07.01.06* A. Separate licenses are required for institutions maintained on separate premises, even though both institutions are operated under the same management. B. Separate licenses are not required for separate buildings on the same grounds. #### Regulation .06-1 Licensed Bed Capacity. *COMAR 10.07.01.06-1* A. On or before July 1, 2000, and each July 1 thereafter, the Secretary shall determine the authorized licensed bed capacity for each hospital classified as a general hospital. B. Methodology for Calculating Total Authorized Licensed Bed Capacity. (1) The average daily census for each general hospital shall be obtained from the most current Health Services Cost Review Commission inpatient utilization data for a 12-month period. (2) The calculation of average daily census shall include the utilization of inpatient medical-surgical, gynecology, obstetric, pediatric, and acute psychiatric service beds. Newborn services are excluded from the calculation of average daily census. (3) The total licensed bed capacity for each general hospital shall equal 140 percent of the calculated average daily census for all inpatient acute care hospital services. C. Application for Designation of Licensed Bed Capacity by Service. (1) The Secretary shall annually forward to each general hospital its calculated total licensed bed capacity for the next licensure period and the current allocation of beds by major service category. (2) In a format specified by the Secretary, each general hospital shall notify the Department of its designation of total beds by major service category for the next licensure period. (3) The Maryland Health Care Commission shall review and approve the designation of total beds by major service category. (4) This section does not permit a general hospital to reallocate bed capacity in a manner inconsistent with applicable statute and regulations. D. On or before July 1, 2000, and each July 1 thereafter, the Secretary shall delicense any licensed hospital beds determined to be excess bed capacity under Regulation .07B of this chapter. E. Temporary Adjustments to Calculated Licensed Bed Capacity. (1) If necessary to adequately meet demand for services, a general hospital may exceed its calculated licensed bed capacity if: (a) On average for the 12-month period, the hospital does not exceed its licensed bed capacity based on the annual calculation; and (b) The hospital includes in its monthly report to the Health Services Cost Review Commission the following information: (i) The number of days in the month the hospital exceeded its licensed bed capacity, and (ii) The number of beds that were in excess on each of those days. (2) A hospital exceeding its calculated licensed bed capacity shall notify the Department within 5 business days of the effective dates of the change in a format specified by the Secretary. #### Regulation .07 Inspections. *COMAR 10.07.01.07* A. New Hospitals. A hospital that began initial operation on or after July 1, 1982, shall be inspected for compliance with the safety and sanitation components of the regulations promulgated by the Department until the hospital receives accreditation by an accreditation organization approved by the Department. If the hospital has not applied for accreditation by an accreditation organization approved by the Department within 1 year after beginning operation or has had its application for accreditation rejected, the Department shall inspect the hospital for compliance with the standards adopted under this subtitle. B. Accredited Hospitals and Accredited Special Rehabilitation Hospitals. An accredited hospital and an accredited special rehabilitation hospital shall be subject to inspection under this chapter by the Department to: (1) Determine compliance with a quality requirement; (2) Follow up on any serious problem identified by an accreditation organization approved by the Department; (3) Investigate a complaint; or (4) Validate the findings of an accreditation organization approved by the Department. C. Nonaccredited Hospitals. Nonaccredited hospitals shall be subject to at least two inspections per year by the Department. D. Inspection by Secretary. The Secretary may inspect any: (1) Hospital record or record of any utilization review agent of a hospital pertaining to review activities under the utilization review plan of the hospital to enforce the provisions of Regulations .13—.22 of this chapter; (2) Physician credentialing record to enforce the provisions of Regulation .24 of this chapter; and (3) Hospital patient safety record, patient complaint record, or hospital patient record pertaining to review activities under a hospital's patient safety program to enforce the provisions of COMAR 10.07.06. #### Regulation .08 Complaint Investigations. *COMAR 10.07.01.08* A. Notwithstanding any other provisions of this subtitle, each hospital and residential treatment center shall be open to inspections by the Department to investigate and resolve any complaint concerning patient care, safety, medical and nursing supervision, physical environment, sanitation, or dietary matters. B. Complaints. (1) To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency, the Department shall refer the complaint directly to the hospital. (2) If appropriate, issues relating to the practice of medicine or the licensure or conduct of a health professional shall be referred to the hospital and may be referred to the appropriate licensure Board for resolution. (3) If the Department determines that the hospital has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a life-threatening deficiency, the Department shall conduct an independent investigation. When conducting its independent investigation, the Department shall use the standards adopted by the Secretary under this subtitle and: (a) For an accredited hospital, the hospital accreditation standards of the accreditation organization that accredits the hospital; (b) For an accredited special rehabilitation hospital, the service standards adopted by the Secretary in Regulation .10 of this chapter; or (c) For a nonaccredited hospital, the standards adopted by the Secretary in Regulation .09 of this chapter. #### Regulation .09 Service Standards — Nonaccredited Hospitals. *COMAR 10.07.01.09* A. Acute General Hospitals and Special Hospitals. Nonaccredited acute general and special hospitals shall comply with The Joint Commission’s Hospital Accreditation Standards. B. Waiver Authority. The Secretary may, for good cause, waive compliance with the incorporated Joint Commission standards. The hospital shall justify the need for the waiver in the manner prescribed by the Department. #### Regulation .10 Service Standards — Special Rehabilitation Hospitals. *COMAR 10.07.01.10* A. Before a special rehabilitation hospital can provide or hold itself out as providing comprehensive physical rehabilitation services, the special rehabilitation hospital shall: (1) Except as otherwise provided in this regulation, be accredited by the Commission on Accreditation of Rehabilitation Facilities; and (2) Meet the standards of the Commission on Accreditation of Rehabilitation Facilities as set forth in the Medical Rehabilitation Standards Manual, which is incorporated by reference under COMAR 10.07.18.05. B. Waiver of Accreditation. (1) To allow a special rehabilitation hospital to achieve accreditation by the Commission on Accreditation of Rehabilitation Facilities as required under this regulation, the accreditation requirement shall be waived for any special rehabilitation hospital that has submitted an appropriate application for accreditation. (2) The waiver under this section shall be effective for not more than 2 years from the later of: (a) July 1, 1986; or (b) The date on which the facility begins operations. #### Regulation .11 Special Rehabilitation Programs — Hospitals. *COMAR 10.07.01.11* A. Except as otherwise provided in this regulation, before a hospital can provide or hold itself out as providing any specialized rehabilitation program, the hospital shall be accredited by the Commission on Accreditation of Rehabilitation Facilities to provide the program. B. The requirement that a hospital be accredited by the Commission on Accreditation of Rehabilitation Facilities before the hospital can provide any specialized rehabilitation program shall be waived if the hospital has applied for accreditation for the program, for not more than 2 years from the later of: (1) July 1, 1986; or (2) The date on which the hospital begins operation of the specialized rehabilitation program. #### Regulation .12 Records and Reports — Inspection. *COMAR 10.07.01.12* Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe by regulation, and all these records shall be open to inspection by the Secretary. #### Regulation .13 Utilization Review Plan. *COMAR 10.07.01.13* A. Before October 1, 1985, each hospital shall submit a proposed utilization review plan to the Secretary. B. Effective October 1, 1985, each hospital shall have in effect a utilization review plan approved by the Secretary pursuant to this chapter. C. The purpose of the hospital's utilization review program, as defined by the plan, shall be to determine for patients included in the hospital's review responsibilities the: (1) Reasonableness and medical necessity of care given or proposed to be given at the hospital; (2) Quality of care given at the hospital; and (3) Appropriateness of the level of care proposed or given, including whether the care could be or could have been provided appropriately and more economically on an outpatient basis or in a facility that provides a lower level of care. D. A utilization review plan shall: (1) Identify the designated utilization review agent; (2) Describe the criteria to be used in evaluating proposed or delivered hospital care; (3) Delineate the types and kinds of cases that the agent will review and the circumstances under which either some or all patients in the hospital, or within specific diagnostic groups, will be selected; (4) Make provisions for the collecting, storing, and reporting of data; (5) Define measures by which the agent can evaluate the effectiveness of its program; (6) Make provisions for screening medical records pertaining to patients for which the agent has review responsibility in order to identify and verify problems in the quality of care; (7) Establish a mechanism through which patients, physicians, or third-party payers may seek reconsideration of decisions made by the utilization review agent; (8) Detail how each of the following elements is to be performed by the agent: (a) Pre-admission review of elective admissions; (b) Post-admission review of nonelective admissions; (c) Concurrent or retrospective review of admissions; (d) Pre-authorization of certain selected procedures proposed to be performed on an inpatient basis; (e) Institution of an objective second surgical opinion protocol to evaluate the desirability of performing selected surgical procedures on an elective basis; (f) Discharge planning review; (g) Continued stay review; and (h) Re-admission review; (9) Meet all other requirements for utilization review promulgated by the Secretary. #### Regulation .14 Utilization Review Agent. *COMAR 10.07.01.14* A. Each hospital shall appoint a utilization review agent to carry out the requirements of the utilization review plan. When the agent is composed of hospital related personnel the hospital's plan shall expressly designate the positions and the organizational structure within the hospital that constitute the utilization review agent for that institution. B. Each utilization review plan shall set forth the manner in which the agent: (1) Utilizes the services of doctors of medicine or osteopathy and other practitioners capable of admitting patients, who are representative of practicing physicians in the area in which the hospital is located. (2) Has available the services of sufficient numbers of physicians and dentists to assure the adequate review of medical specialty and subspecialty cases. (3) Utilizes the services of registered nurses, medical records technicians, or similarly qualified persons supported and supervised by physicians in carrying out its review activities. (4) Uses only a doctor of medicine, osteopathy, or dentistry to make a final determination that care rendered or to be rendered was, is, or may be medically inappropriate. (5) Makes direct comparisons with professionally developed, objective criteria to determine the appropriateness of admission and continued stay. The criteria should: (a) Be nationally recognized and accepted, unless a special exception is granted by the Secretary; (b) Be capable of being utilized to define the type and extent of services which are to be considered as within the range of appropriate diagnosis and treatment for a given condition; (c) Identify the level of care at which the services can appropriately and economically be rendered; and (d) Recognize that for many conditions more than one mode or site of treatment or diagnosis may be medically acceptable. (6) Collects information relevant to its function, maintains records, and reports to the Department as required. The hospital's utilization review plan shall outline the method by which patient confidentiality shall be maintained. C. A member of the agent's staff, or any person that the agent may delegate or employ, may not review or make a determination of appropriateness for care that that person was directly responsible for providing, or which was provided by or to a member of that person's family. #### Regulation .15 Performance Standards for Utilization Review. *COMAR 10.07.01.15* The hospital's program shall apply to all patients with the exceptions of those noted in Regulation .17, below. Except when noted for certain types of review, the program may delineate certain types and kinds of cases to be reviewed, so as to most efficiently carry out the purposes of these regulations. As a minimum, the hospital utilization review program shall satisfy the following performance standards: A. Pre-admission Review. (1) A review of those elective admissions identified under the plan shall be performed by the agent in advance of the proposed admission. (2) The purpose of this review shall be to determine the reasonableness and medical necessity of the admission, and the appropriateness of the level of proposed care. (3) In conducting the review, the agent may supplement the information provided by the hospital through discussion with the patient's physician. (4) The agent, using specific medical criteria, shall render a decision as to whether the admission is medically appropriate within 3 working days of the time it receives the case, except in those circumstances when responding within this period would not permit sufficient consultation or discussion to render a responsible opinion. B. Post-admission Review. (1) For those categories of emergency admissions identified for review in the hospital's plan, the agent shall carry out a review to ascertain the: (a) Reasonableness and medical necessity of the admission; (b) Appropriateness of the level of care provided; and (c) Justification for the non-elective nature of the admission. (2) The agent shall be notified by the hospital within 24 working hours of the admission and the agent shall carry out the review within 3 working days of notification, except in cases when appropriate consultation cannot be carried out in this period of time. C. Concurrent or Retrospective Review. (1) For patients included in the plan the agent shall determine whether each day of the patient's hospitalization was medically necessary and appropriate based upon nationally recognized criteria. The agent shall also designate those days of hospitalization caused by administrative requirements including days on which patients await appropriate placement or equipment needed after discharge. (2) The review may be concurrent with the patient's stay or take place after the patient is discharged. (3) Days designated as administrative shall be found appropriate only if approved under discharge planning review, as discussed in §F. D. Pre-authorization Review. (1) The agent shall review prospectively all elective admissions in which one or more of the plan designated procedures is the principal procedure being performed for that admission. (2) The procedures for which pre-authorization is required are set forth in Regulation .21. (3) The agent may approve inpatient treatment for the listed procedures only if there is documentation that equivalent outpatient treatment would not be medically appropriate for the patient. (4) All non-elective admissions that have not been pre-authorized and that subsequently involve performance of one or more of the plan designated procedures shall be reviewed concurrently or retrospectively by the agent. E. Objective Second Opinion. (1) Before an elective admission for a surgical procedure designated below, the patient shall obtain an objective second opinion. (2) The procedures for which a second opinion is required are set forth in Regulation .22. (3) The second opinion may be rendered by any physician of the patient's choosing except a physician having any financial relationship with the patient's original physician. (4) Should a voluntary admission not take place within 6 months of the rendering of the second opinion, then another opinion shall be sought before admission. (5) The agent may waive the requirement for obtaining a second opinion because: (a) Obtaining the second opinion would impose a hardship on the patient; or (b) The patient's medical insurance does not cover second opinions, and was: (i) Issued and delivered in another state, and (ii) Not intended to cover persons living or working in Maryland. F. Discharge Planning. (1) The utilization review plan shall set forth the hospital's discharge planning procedures. (2) The agent shall review the effectiveness of the hospital's discharge planning. (3) The agent shall review those days of care which have been designated to be administrative as a result of the agent's concurrent or retrospective review. (4) Administrative days may be approved as necessary and appropriate only if evidence can be found that the hospital has developed and implemented a discharge plan at the earliest possible time and there is evidence that appropriate placement efforts have been made. G. Continued Stay Review. For patients in beds licensed for long term care, the agent shall periodically review and certify as appropriate the level of care and placement, and the medical necessity of treatment prescribed. H. Re-admission Review. The agent shall review the appropriateness of the previous discharge and the indications for admission for hospitalizations occurring shortly after a previous discharge. #### Regulation .16 Protection of Patients — Patient Liability. *COMAR 10.07.01.16* A. Charges for any days disallowed as a result of retrospective review by the agent or by a payer conducting utilization review under these regulations shall be deducted from the gross charges in the bill to the patient as a contractual allowance unless the patient refuses or has refused to leave the hospital when it is medically appropriate to do so, and the disallowed days occur: (1) After the hospital has notified the patient in writing of the potential disallowance; or (2) As a direct result of the noncompliance by the patient to treatment or hospital regulations. B. If a bill is generated before the receipt of the results of retrospective review, a subsequent adjustment to the bill, if required under Sec. A, above, shall be issued by the hospital. The final bill shall demonstrate all procedures, services, or days of care found to be inappropriate. C. In cases when a form of review other than retrospective review was performed, each patient bill generated by the hospital shall clearly demonstrate all procedures, services, or days of care which have been found to be inappropriate or have been disallowed by the hospital's utilization review agent or any other reviewer or payer conducting utilization review. D. The utilization review agent shall be responsible for establishing a process by which physicians and patients may request clarification and reconsideration of review decisions. These clarifications or reconsiderations shall be carried out in a timely fashion, and patients shall be granted full access to any medical records maintained by the agent pertaining to their care to the extent permitted under Health-General Article, § 4-302, Annotated Code of Maryland. #### Regulation .17 Exemptions from Hospital Utilization Review. *COMAR 10.07.01.17* A. A hospital shall be exempt from carrying out utilization review procedures for a given patient if the: (1) Person, corporate entity, or insurance plan paying for the patient's hospitalization has a utilization review program that is determined by the Insurance Commissioner and the Secretary to substantially meet the minimum standards described in these regulations, including the reporting requirements detailed in Regulation .19 of this chapter, those programs and amendments to them having been submitted to the Commissioner for approval; (2) Patient is a subscriber or a member of a health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland; or (3) Patient is a Medicare or Maryland Medical Assistance Program beneficiary, and the services rendered at the hospital are within the scope of coverage provided by the relevant program. B. The Secretary will issue yearly lists of third-party payers known to have utilization review plans that qualify for the exemption described in this regulation. #### Regulation .18 Record Maintenance by Utilization Review Agents. *COMAR 10.07.01.18* A. The plan shall describe how, in addition to maintaining documents which describe its utilization review procedures, the agent shall maintain the following records for each individual patient for whom any aspect of the utilization review procedure has been applied: (1) The patient's name, hospital history number, source of payment, and other demographic information capable of identifying the patient. (2) The principal diagnosis or diagnoses (with corresponding codes listed in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) as defined in COMAR 10.09.06.01P), and the particular category of patient chosen for review in accordance with the hospital's utilization review plan. (3) The date or dates on which review activities were requested and the date or dates on which opinions were rendered. (4) The type of review carried out, the nature of the criteria applied, and the results of the review. In the case of disallowed services, the reasons for disallowance shall be stated, as well as the name of the physician member of the agent's staff making the final disallowance determination. (5) In the case of objective second opinions, documentation shall include the name of the physician rendering the second opinion, the physician's specialty, and the nature of the opinion. B. Each agent shall maintain a listing of all reviewed cases suitable for the selection of a sample of all cases reviewed within each 2-year certification period. #### Regulation .19 Reports to the Secretary. *COMAR 10.07.01.19* A. Each hospital shall report annually to the Secretary the following summary statistics on the activity of its utilization review program: (1) The number of discharges and total patient days reviewed under the program; (2) For each of the procedures requiring pre-authorization for inpatient treatment, the number of patients: (a) Reviewed; and (b) Approved for inpatient treatment; (3) For each of the procedures requiring an objective second opinion, the number of patients: (a) Undergoing the procedure at the hospital; (b) Admitted non-electively for the procedure; (c) Admitted electively after the patient had obtained a second opinion; and (d) Admitted electively but for whom the requirement of a second opinion was waived, including a tabulation of the reasons for waivers; (4) For admissions reviewed concurrently or retrospectively, the number of all reviewed admissions disapproved, and reasons for disapproval; (5) The number of all reviewed days of hospitalization disapproved, by reason for disapproval; (6) A summary of the findings of re-admission review, including the frequency and proportion of these cases, the diagnoses or treatments involved, and the reasons found; (7) A listing and description of quality care problems found by the agent in the course of reviewing patient records in furtherance of its duties under the utilization review plan. B. The Secretary shall be allowed access to hospital patient records and to the records of the hospital's utilization review agent pertaining to review activities under the plan for the purpose of enforcing these regulations. #### Regulation .20 Penalties. *COMAR 10.07.01.20* If a hospital fails to submit a utilization review plan or fails, after adequate discussion with the Department, to develop an approvable plan, or fails to operate a plan which has been approved, then the Secretary may impose upon the hospital the following penalties: A. Delicensure of the hospital; or B. A fine of $500 for each day that the hospital is in violation of these regulations. #### Regulation .21 Procedures for Which Preauthorization is Required — Repealed. *COMAR 10.07.01.21* #### Regulation .22 Practitioner Performance Evaluation. *COMAR 10.07.01.22* A. Consistent with the standards of the Joint Commission for focused and ongoing professional performance evaluations, the hospital shall establish a practitioner performance evaluation process that objectively evaluates the performance of each member of the medical staff. B. The hospital’s practitioner performance evaluation process shall include a review of care which shall: (1) Be undertaken for cases: (a) Chosen at random; and (b) With unexpected adverse outcomes; (2) Be based on objective review standards; (3) Include a review of the appropriateness of the plan of care for the patient, particularly any medical procedures performed on the patient, in relation to the patient’s condition; and (4) Be conducted by members of the medical staff, or at the discretion of the hospital, by external reviewers, who: (a) Are of the same specialty as the member of the medical staff under review; (b) Have been trained to perform practitioner performance evaluation; and (c) Are not otherwise associated with the case under review. C. A hospital shall take into account the results of the practitioner performance evaluation process for a member of the medical staff in the reappointment process. #### Regulation .23 Guidelines Governing the Transfer of Patients Between Hospitals. *COMAR 10.07.01.23* A. If a hospital is able to provide adequate care to a patient, the hospital may not transfer the patient to another hospital unless: (1) One or more of the following circumstances is present: (a) The patient does not have a physician with privileges at the hospital and the patient refuses treatment by any physician with privileges at the hospital; (b) The patient or a legally authorized representative of the patient requests the transfer; (c) The transfer is in compliance with relevant sections of Health-General Article, Title 10, Subtitle 8, Annotated Code of Maryland; (d) The transfer is in compliance with the Interstate Compact on Mental Health as adopted in Health-General Article, Title 11, Annotated Code of Maryland; or (e) The transfer is in compliance with any agreement entered into between the Department and a hospital for the provision of acute inpatient psychiatric care in State hospital conversion beds; (2) These circumstances are documented in the patient's medical record; and (3) The provisions of this regulation are met. B. A hospital may not use the inability of a patient to pay or the source of payment for a patient as a reason to transfer the patient to another hospital. C. Before moving a patient, the transferring hospital shall: (1) Determine that the patient can be transferred without causing harm to the patient; (2) Notify the receiving hospital of the transfer; and (3) Unless otherwise provided for in an agreement with the Department for State hospital conversion beds, obtain from the receiving hospital confirmation that: (a) The receiving hospital consents to accept the patient; and (b) The patient meets any criteria that the receiving hospital has established for admission regarding: (i) The patient's required level of care; (ii) Physician services available; and (iii) Other services necessary to treat the patient. D. Explanation of Transfer. (1) Except as otherwise provided in §C(2),, of this regulation, before moving a patient, the transferring hospital shall provide explanation of the reasons for the transfer and any alternative to the transfer to the patient or to a legally authorized representative of the patient. (2) If the transferring hospital can document that the necessity to move the patient to the receiving hospital is immediate to protect the health, safety, or welfare of the patient, the transferring hospital may give the explanation required in §C(1), of this regulation, concurrently with the transfer. E. In effecting a transfer, the transferring hospital shall provide that: (1) Medically appropriate life-support measures that a reasonable and prudent physician exercising ordinary care would use are used to stabilize the patient before transfer and sustain the patient during transfer; (2) Appropriate personnel and equipment that a reasonable and prudent physician exercising ordinary care would use are provided and used in the transfer; and (3) All records necessary for continuing the patient's care are transferred with the patient. F. The Department shall inspect hospitals for compliance with this regulation as provided in Regulations .07 and .08 of this chapter. G. Penalties. (1) The Secretary may impose a penalty not exceeding $1,000 per violation on any hospital that violates this regulation. (2) In determining the amount of the penalty, the Secretary shall consider: (a) The hospital's history of previous violations; (b) The seriousness of the violation; (c) Whether the hospital demonstrated good faith in attempting to comply with this regulation; and (d) Whether the violation threatened the health or safety of: (i) A patient; or (ii) The public. #### Regulation .24 Physician Credentialing Process. *COMAR 10.07.01.24* A. General. In accordance with this regulation, a hospital shall have in effect a credentialing process. B. Scope of Credentialing Process. The credentialing process shall apply to any physician who shall admit or treat patients in the hospital. C. Specific Standard — Appointment and Employment Process. (1) In accordance with this section, a hospital shall establish a formal written process for the appointment or employment of a physician by the hospital. (2) The term of an appointment may not exceed the term established by the standards of the accreditation organization that accredits the hospital. (3) The formal written appointment or employment process shall provide for a probationary period that shall be successfully completed before the finalization of the appointment or employment of the physician. (4) As part of the formal written appointment and employment process, the hospital shall collect, verify, review, and document the following information about the physician: (a) The physician's education; (b) The clinical expertise of the physician; (c) The professional experience of the physician including: (i) Any board certification or specialty training of the physician; (ii) The internship of the physician; and (iii) The residencies of the physician; (d) Any license or registration to practice a health occupation ever held by the physician, including: (i) A license to practice medicine; and (ii) DEA registration; (e) Whether any license or registration to practice a health occupation ever held by the physician has been: (i) Suspended; (ii) Revoked; (iii) Voluntarily surrendered or not renewed; (f) Concerning any hospital where the physician was appointed or employed: (i) The name of the hospital; (ii) The term of appointment or employment; (iii) Privileges held and any disciplinary action taken on the privileges, including suspension, revocation, limitation, or voluntary surrender; (g) Concerning the physician's professional liability insurance: (i) The physician's present carrier; (ii) The physician's current limits of coverage; (iii) The physician's current types of coverage; (iv) Restrictions on the physician's coverage; and (v) Whether or not the physician has maintained continuous malpractice coverage since first obtaining professional insurance; (h) Any claim that has been made against the physician in the practice of any health occupation and the status of the claim; (i) The physician's medical history including the physician's current mental and physical health status; (j) A complaint or report filed with: (i) The Board of Physicians or any other state medical discipline agency; (ii) A state medical society; (iii) A state disciplinary body; or (iv) A professional or specialty association. (5) The formal written process shall provide for the documentation of any action taken by the hospital regarding the appointment or employment of the physician. (6) Uniform Standard Credentialing Form. (a) A hospital shall use the uniform standard credentialing form approved by the Department for the initial credentialing of a physician seeking appointment or employment. (b) Use of the uniform standard credentialing form does not preclude a hospital from requiring additional information, attestations, or supplemental documentation as required by that hospital's credentialing process. (c) A physician seeking hospital privileges shall submit an updated and complete uniform standard credentialing form at the time of application to each hospital. D. Specific Standard — Granting of Delineated Clinical Privileges. (1) In accordance with this section, a hospital shall establish a formal written process for the granting of delineated clinical privileges. (2) The formal written process shall include: (a) Criteria for determining whether a physician shall be granted privileges by the hospital to provide specific services; (b) Criteria for ongoing evaluation of the performance of the services for which privileges have been granted; (c) Procedures for altering, suspending, or revoking the delineated privileges. (3) The formal written process shall provide for documentation of any actions taken regarding delineated privileges. E. Specific Standard — Reappointment. (1) In accordance with this section, a hospital shall establish a formal written process for the reappointment of a physician who has been appointed to the hospital. (2) The term of reappointment shall be 2 years or less. (3) As part of the formal written appointment process, a hospital shall collect, verify, review, and document the following information about the physician: (a) An update of the information regarding appointment under §C of this regulation; (b) Concerning the physician's pattern of performance based on an analysis of the following: (i) Claims filed against the physician; (ii) Utilization, quality and risk data; (iii) A review of clinical skills; (iv) Adherence to hospital bylaws, policies, and procedures; (v) Compliance with continuing medical education requirements; (vi) An assessment of current mental and physical health status; (vii) Attitudes, cooperation, and the ability to work with others; and (viii) The results of the Practitioner Performance Evaluation process as described in Health-General Article, §§19-3B-01—19-3B-09, Annotated Code of Maryland. F. Specific Standard — Record Maintenance. (1) In accordance with this section, a hospital shall maintain a separate credentialing file for each physician. (2) The credentialing file for each physician shall contain documentation relating to the credentialing process required under this regulation. G. Disaster Privileges. (1) During an emergency or disaster in which the hospital's disaster or emergency management plan has been activated, when the Governor has declared that a state of emergency exists, or when the Secretary has issued an order pursuant to Health-General Article, §18-905, Annotated Code of Maryland, the chief executive officer, medical staff president, or designee may grant temporary disaster privileges to licensed physicians who have not been appointed to the hospital's medical staff. (2) The hospital shall develop a medical staff plan for the granting of disaster privileges that identifies: (a) The individual responsible for granting disaster privileges; (b) The responsibilities of that individual; (c) A system to manage, assign, and supervise the physicians who have been granted disaster privileges; and (d) The process by which credentials and privileges are verified as soon as the situation allows, ensuring that the process complies with §C of this regulation. (3) Physicians granted disaster privileges by a hospital shall: (a) Be registered and trained by the Department as part of the Department's Maryland Physician Volunteer Corps and possess the Department issued photo identification; or (b) Comply with the hospital's medical staff plan for granting privileges in a disaster, which shall require at least one of the following: (i) Presentation of a current Maryland license to practice medicine and a valid identification picture (ID) issued by a state, federal, or regulatory agency; (ii) Presentation of a license to practice medicine from another state if a state of emergency has been declared by the Governor and the assistance of the physician has been requested by Maryland pursuant to the Emergency Management Assistance Compact, Public Safety Article, §14-702, Annotated Code of Maryland; (iii) Presentation of a current photo identification card from another Maryland hospital where the physician is a member of the medical staff; or (iv) Verification by a current member of the hospital's medical staff who has personal knowledge regarding the practitioner's identity and current Maryland medical licensure. (4) Disaster privileges shall be discontinued when the hospital's chief executive officer, medical staff president, or designee determines that the emergency condition no longer exists and that the hospital has adequate resources to meet the patient's needs. (5) The hospital shall maintain records that include: (a) The number of hours worked by each physician; (b) The type of service provided by each physician; (c) The location where these services were provided; and (d) Any additional information required by the Department for federal and State reimbursement. H. Telemedicine. Notwithstanding any other provision of COMAR 10.07.01.24, in its credentialing and privileging process for a physician who provides medical services to the patients at the hospital only through telemedicine from a distant-site hospital or distant-site telemedicine entity, a hospital may rely on the credentialing and privileging decisions made for the physician by the distant-site hospital or distant-site telemedicine entity as authorized under 42 C.F.R. Part 482, if: (1) The physician who provides medical services through telemedicine holds a license to practice medicine in the State under Health Occupations Article, Title 14, Annotated Code of Maryland; and (2) The credentialing and privileging decisions with respect to the physician who provides medical services through telemedicine are: (a) Approved by the medical staff of the hospital; and (b) Recommended by the medical staff of the hospital to the hospital’s governing body. I. Request for Documentation by Department. On request from the Department, a hospital shall provide documentation that before: (1) Appointment or employment of a physician or granting delineated privileges, the hospital has complied with the requirements of this regulation; and (2) Reappointment or renewing of employment or specific privileges, the hospital has complied with the requirements of this regulation. J. Penalties. If a hospital fails to have in effect a credentialing process in accordance with these regulations, the Secretary may impose upon the hospital the following penalties: (1) Delicensure of the hospital; or (2) A fine of $500 for each day that the hospital is in violation of these regulations. #### Regulation .25 Medical Professional Liability Closed Claim Form. *COMAR 10.07.01.25* A. A hospital shall complete and submit to the Department the approved Medical Professional Liability Closed Claim form, for each medical liability claim filed regarding the care or services received by a patient under the care of that hospital. B. Regardless of the result of a closed claim, the hospital shall submit the Medical Professional Liability Closed Claim form to the Department within 90 days after the end of the quarter during which the final judgment, settlement, or final disposition of the claim was made. #### Regulation .26 Anatomical Donations. *COMAR 10.07.01.26* A. This regulation does not: (1) Limit the right of an individual to make a gift under the Anatomical Gift Act, Estates and Trusts Article, Title 4, Subtitle 5, Annotated Code of Maryland; or (2) Interfere with the duties of the office of the Chief Medical Examiner. B. A hospital shall develop and follow a protocol in accordance with this regulation for the procurement of organs and tissues. C. Requests for Donation on Death of Patient. (1) In accordance with this regulation, whenever a patient of a hospital meets the following criteria, the administrator of the hospital shall designate a person to request that the representative of the patient consent to the donation of the organs and tissues of the patient: (a) The patient may be pronounced dead in accordance with Health-General Article, §5-202, Annotated Code of Maryland; (b) The patient has not given actual notice of an objection to the donation of his or her organs and tissues; and (c) The patient has not made a gift of all or part of his or her body under the Anatomical Gift Act, Estates and Trusts Article, Title 4, Subtitle 5, Annotated Code of Maryland. (2) A hospital may not make a request for consent to a donation if the use of all of the organs or tissues of the patient is medically contraindicated. (3) In making a request required in §C(1), of this regulation, the hospital designee shall: (a) Make a reasonable effort to locate and contact the appropriate person set forth in §D, of this regulation, as the representative of the deceased patient; and (b) Request that the representative consent to a donation of any organ or tissue of the patient which is suitable for donation. D. Determination of Patient Representative for Consent to Donation. (1) The representative of a deceased patient shall be: (a) The spouse of the patient, but, if the spouse is not competent; then (b) Any adult son or daughter of the patient, but, if no adult child of the patient is competent; then (c) Either parent of the patient, but, if neither is competent; then (d) Any adult brother or sister of the patient, but, if no adult sibling of the patient is competent; then (e) Any guardian of the person of the patient, but, if the patient has no guardian of his or her person; then (f) Any other person authorized or obligated by law to dispose of the body of the patient. (2) If the death of a patient occurs suddenly and the patient was in apparent good health or unattended by a physician, the hospital shall notify and cooperate with the office of the Chief Medical Examiner before the removal of any organ or tissue. E. Discretion and Sensitivity in Making Requests. In making a request for donation, the hospital designee shall show reasonable discretion and sensitivity to the: (1) Circumstances of the family of the patient; (2) Religious beliefs of the patient; and (3) Suitability of the organs or tissues for donation. F. Documentation. The designee shall document in the medical record of the patient: (1) Any request made for donation of organs or tissues; (2) Any consent to donate organs or tissues; (3) Whether a donation is made and accepted; (4) Any objection to the donation made by: (a) The patient, or (b) An appropriate representative of a patient as set forth in §D of this regulation; and (5) The reason for electing not to make a request for organ or tissue donation. #### Regulation .27 Discharge Planning Requirements. *COMAR 10.07.01.27* A. Discharge Options. A hospital may discharge a patient: (1) Entirely; (2) To another level of care, treatment, or services; (3) To different health care professionals; or (4) To settings for continued services. B. A hospital's process for transfer or discharge shall be based on a patient's assessed needs at the time of discharge. C. To facilitate discharge or transfer, the hospital shall: (1) Assess the patient's needs beginning at an early stage of the patient's hospitalization and as the patient's needs change throughout the hospitalization; (2) Develop plans for the patient's discharge or transfer with input, if appropriate, from the patient, the family, or other interested party; (3) Identify appropriately qualified staff, such as registered nurses or licensed social workers, who have the knowledge and experience necessary to determine what services or type of providers can best meet the patient's discharge needs; (4) Arrange or help to arrange for services needed to meet the patient's needs after discharge; and (5) Provide the patient, or the provider who is responsible for providing continuing care to the patient, with written discharge instructions and other necessary medical information in a form the patient or provider can understand. #### Regulation .28 Emergency and Disaster Plan. *COMAR 10.07.01.28* A. A licensed acute general hospital or special hospital shall comply with the Emergency Management standards outlined in The Joint Commission’s Hospital Accreditation Standards. B. A licensee shall prepare an executive summary of the hospital's evacuation procedures to provide to a patient, family member, or legal representative upon request. The summary shall: (1) Describe the hospital's Emergency Operation Plan (EOP), which is discussed throughout the Emergency Management standards cited in §A(1) of this regulation; and (2) Describe the role and responsibilities of a patient, family member, or legal representative in the event of an emergency situation. C. A licensee shall have a tracking system to assist the hospital, family members, government representatives, and other authorized stakeholders, to locate and identify patients in the event of displacement due to an emergency or disaster. #### Regulation .29 Notice to Patients of Outpatient on Observation Status. *COMAR 10.07.01.29* A. A hospital shall provide both an oral and written notice to a patient of: (1) The patient’s outpatient on observation status; (2) The billing implications of the outpatient on observation status; and (3) The impact of the outpatient on observation status on the patient’s eligibility for Medicare rehabilitation services if: (a) The patient received on-site services from the hospital for more than 23 consecutive hours; (b) The on-site services received by the patient include a hospital bed and meals that have been provided in an area of the hospital other than the Emergency Department; and (c) The patient is classified as an outpatient at the hospital for observation rather than as an admitted inpatient. B. The written notice shall include: (1) That the patient is considered to be on observation as an outpatient and is not admitted as an inpatient; (2) The reason or rationale that the patient has not been admitted for inpatient services; (3) That the patient, if needed upon discharge, may not qualify for Medicare Part A reimbursement for rehabilitation services, including such services provided under Medicare Part A in a skilled nursing facility; (4) That there may be billing implications based on their outpatient status that may increase the patient’s out-of-pocket costs for their stay; (5) The name and title of the staff who provided the oral notice stating the date and time of the oral notice; and (6) The signature of the patient to verify an understanding and receipt of the written notice. C. Once the patient has received onsite services for more than 23 hours, the hospital shall provide written and oral notice to the patient that the physician has ordered services be provided as outpatient on observation status. D. The oral and written notice shall be provided in a manner that is understood by the patient. E. If the patient lacks capacity to understand the medical or financial implications of his or her outpatient on observation status, the oral and written notice shall be provided to a person authorized to make medical or financial decisions for the patient, including: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An agent appointed under an advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) An agent appointed under a power of attorney that meets the requirements of Estates and Trusts Article, Title 17, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) Any other person, if that person was designated by the patient who was competent at the time of designation, and the patient or representative has provided the hospital with documentation of the designation. F. For Medicare patients only, a hospital has the option to provide only the notice required by Medicare under 42 CFR §489.20(y). Hospitals that elect to use that option shall be considered compliant with this regulation if the notice is provided to patients that receive on-site services for more than 23 hours. #### Regulation .30 Physical Environment. *COMAR 10.07.01.30* A. The facility shall be in compliance with: (1) The Facilities Guidelines Institute's Guidelines for Design and Construction of Hospitals; and (2) All applicable State and local governing laws, regulations, standards, ordinances, and codes for fire safety, building, and zoning requirements. B. Any waiver or other modification of these requirements shall be addressed by the appropriate State or local authority having jurisdiction in accordance with established procedures. #### Regulation .31 Hospital Palliative Care Programs. *COMAR 10.07.01.31* A. Acute general hospitals and special hospitals-chronic care with 50 or more beds shall establish an active hospitalwide palliative care program that provides consultation services to patients suffering from pain and symptoms due to serious illnesses or conditions. B. The hospital shall: (1) Promote the palliative care program; (2) Provide information and referrals to patients and families when appropriate regarding the availability of palliative care services; and (3) Inform patients of the patient’s right to request a palliative care consultation. C. Staffing. (1) The hospital shall designate a qualified interdisciplinary care team with training in palliative care to staff the palliative care program. (2) The hospital shall ensure that: (a) A qualified health care professional coordinates the activities of the palliative care program with the palliative care patient’s interdisciplinary care team; (b) Staff is appropriately trained, credentialed, or certified in the staff’s area of expertise; (c) Staff receives continuing training and education; and (d) Written policies and procedures for the hospital palliative care program are established, implemented, maintained, and updated periodically. D. Palliative Care Education and Training. The hospital shall provide and document training to medical and other clinical staff as determined by the hospital regarding: (1) Services provided by the palliative care program; (2) Domains of palliative care; and (3) Legal requirements for: (a) Health care decisions; and (b) MOLST as referenced in COMAR 10.01.21. E. Interdisciplinary Plan of Care. (1) The hospital shall incorporate the recommendations of the palliative care program into the palliative care patient’s interdisciplinary care plan. (2) The hospital shall review the interdisciplinary plan of care and revise it as necessary to meet the needs of the palliative care patient. (3) The palliative care program shall conduct care conferences as appropriate to review the plan of care with: (a) The palliative care patient; (b) The palliative care patient’s family; (c) The health care professionals; and (d) Other interdisciplinary team members. (4) Contents. The hospital shall ensure that the palliative care patient’s plan of care includes at a minimum: (a) Initial assessments conducted by the interdisciplinary palliative care team; (b) Psychological needs assessment; (c) Treatment goals; (d) Choice of treatment options; (e) Preferred care setting; (f) Availability of hospice services; (g) Preferred site of death and after-death arrangements, as appropriate; (h) Grief and bereavement plan, as appropriate; (i) Assessment of cultural needs; (j) Assessment of legal needs; and (k) Assessment of discharge needs. (5) Collaboration. The hospital shall document and provide palliative care services in collaboration with: (a) The attending physician; and (b) Any other health care provider managing the patient’s care. (6) Continuity of Care. The hospital shall coordinate services to ensure continuity of care for the palliative care patient. The hospital shall: (a) Transfer the pertinent parts of the medical record, medical orders, and plan of care with the palliative care patient upon transfer to post-acute care; (b) Ensure that MOLST forms are completed in accordance with COMAR 10.01.21; (c) Convert a palliative care patient’s treatment goals into medical orders, as appropriate; and (d) Have reporting mechanisms to keep all staff informed and updated about care changes and treatment goals. F. Palliative Care Services. (1) The hospital or palliative care program shall counsel the palliative care patient or the patient’s authorized decision maker regarding: (a) Health options; (b) Pain management options; (c) Prognosis; (d) Risks and benefits of treatment; (e) Availability of grief and bereavement services, as appropriate; (f) Psychological services; (g) Availability of spiritual care counseling through the hospital or outpatient providers; and (h) Hospice services, as appropriate. (2) Referrals. (a) As appropriate and upon request by the patient or authorized decision maker, the hospital may make timely referrals. (b) The hospital shall document any referrals made to: (i) Inpatient or outpatient bereavement providers; (ii) Psychological services for the palliative care patient and the patient’s family; (iii) Inpatient or outpatient spiritual care services; and (iv) Hospice. (3) Pain and Symptom Management. The hospital shall: (a) Conduct and document pain and symptom assessments using available standardized scales to appropriately manage a palliative care patient’s symptoms; (b) Provide adequate and appropriate dosage of analgesics and sedatives to meet the needs of the palliative care patient; and (c) Educate the patient and the patient’s family about the use of opioids during end-of-life care. (4) Other Services. The hospital shall provide culturally and linguistically appropriate education and support about how to safely care for the patient at home or in an alternate residential setting as appropriate. (5) Imminent Death. The palliative care program shall document and counsel the patient, the authorized decision maker, the patient’s family, and the interdisciplinary care team about the active dying phase and imminent death as appropriate. (6) MOLST. The hospital shall comply with the procedures and requirements of the Medical Orders for Life-Sustaining Treatment Form, which is incorporated by reference at COMAR 10.07.21. (7) Interpreter Services. The hospital shall ensure interpreter services are available and accessible to the palliative care program. G. Advance Directives. (1) The hospital shall recognize the authority of: (a) An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland; and (b) An authorized decision maker. (2) The hospital shall ensure that any provided advance directive and authorized decision maker designation are in the patient’s medical record, including the electronic medical record. (3) The hospital shall promote advance care planning and the completion of advance directives through community outreach activities. H. Ethics Committee. The hospital shall allow staff, patients, and the patient’s family in the palliative care program access to an ethics committee to address ethical conflicts at the end of life. I. Quality Improvement. The palliative care program shall take part in the hospital’s quality improvement and performance improvement activities to the extent required by State and federal statute. J. Departmental Oversight. The Department shall have access to all data maintained through the hospital’s palliative care program to determine the hospital’s compliance with State and federal regulations. #### Regulation .32 Penalties — General. *COMAR 10.07.01.32* A. The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home. B. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home. C. The Secretary may deny or revoke a license if the hospital does not meet the requirements of: (1) Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; (2) Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, including this chapter. D. A hospital subject to a fine or a penalty, or to delicensure, denial, or revocation of license under these regulations, may request a hearing as set forth under State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 10.01.03. #### Regulation .32-1 Civil Money Penalties — Imposition. *COMAR 10.07.01.32-1* A. The Department may impose a civil money penalty not to exceed $10,000 for each failure of a hospital to comply with the requirements of Regulation .27 of this chapter. B. In determining whether to impose a civil money penalty, the Department may consider the following factors: (1) The number of failures to comply; (2) The nature and seriousness of the failure to comply; (3) The degree of risk to the health, life, or safety of the patient being discharged that is caused by the failure to comply; (4) A hospital's prior history to comply with discharge requirements; and (5) Such other factors as justice may require. #### Regulation .32-2 Civil Money Penalties — Payment of Penalty. *COMAR 10.07.01.32-2* A. If a hospital owes a civil money penalty to the Department, the hospital shall adhere to the procedures of this regulation. B. A civil money penalty payment is due to the Department 15 calendar days after: (1) The time period for requesting a hearing has expired if a request for hearing is not received; or (2) Receipt of a written request from the hospital to waive its right to a hearing and reduce the amount of the civil penalty by 40 percent, if the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty. #### Regulation .32-3 Civil Money Penalties — Hearings. *COMAR 10.07.01.32-3* A. A hospital aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary has the burden of proof with respect to the imposition of civil money penalties. #### Regulation .33 Uniform Emergency Codes. *COMAR 10.07.01.33* A. Each hospital shall adopt and implement the following set of uniform codes for the identified emergency situations as part of its emergency or disaster plans: (1) Fire — Code Red; (2) Infant or Child Abduction — Code Pink; (3) Cardiac Respiratory Arrest — Code Blue — Adult; (4) Cardiac Respiratory Arrest — Code Blue — Child; (5) Cardiac Respiratory Arrest — Code Blue — Infant; (6) Combative Person — Code Green; (7) Bomb Threat — Code Gold; (8) Hazardous Material Spill or Release — Code Orange; (9) Elopement — Code Gray; (10) Security Only Response — Code Purple; (11) Emergency or Disaster — Code Yellow; and (12) Armed Assailant — Code Silver. B. A hospital may adapt the uniform codes referenced in §A of this regulation to meet the specific needs of the hospital by adding a suffix or additional words after that code. C. For emergency situations not addressed by the codes in §A of this regulation, a hospital may establish its own identifying code. D. A hospital shall adopt only those uniform color codes that are consistent with the services or needs of the hospital. E. As part of its emergency or disaster plan, the hospital shall establish its own protocol for each of the uniform codes. F. A hospital shall provide orientation and training to all staff regarding the uniform emergency codes and the hospital's emergency or disaster plan. G. A hospital seeking exceptions to the requirements of this regulation shall submit its plan for emergency codes to the Department for review and approval: (1) Within 90 days after the effective date of this regulation; or (2) Before implementation of changes in its emergency code that would not comply with §§A—F of this regulation. #### Regulation .34 Infection Prevention and Control Program. *COMAR 10.07.01.34* A. The hospital shall have an active hospital-wide program for the prevention, control, and investigation of communicable diseases and infections. B. Staffing. (1) The hospital shall designate qualified staff with training in infection prevention and control to be responsible for the implementation of the infection prevention and control program. (2) Additional clinical and support staff shall be provided for the infection prevention and control program based on the size and complexity of the hospital's services. C. Infection Prevention and Control Program. (1) The infection prevention and control program shall be based on nationally recognized, evidence-based standards. (2) The infection prevention and control program shall be developed using an interdisciplinary approach with input from: (a) Administrative staff; (b) Medical staff; (c) Pharmacy staff; (d) Laboratory personnel; (e) Nursing staff; (f) Physical plant personnel; (g) Employee health personnel; (h) Patient safety officer; and (i) Staff from other departments whose knowledge and experience would contribute to improved infection prevention and control. (3) Written policies and procedures for the infection prevention and control program shall be established, implemented, maintained, and updated periodically. D. Surveillance. (1) The hospital shall: (a) Have a process for the identification and surveillance of healthcare- associated infections; (b) Analyze and utilize surveillance data to monitor and improve infection control and healthcare outcomes; and (c) Maintain a log of the identified infections. (2) The infection prevention and control program shall include: (a) Processes for the monitoring and control of patients who have a communicable disease or infection to prevent its spread to other patients and staff; (b) A process to identify and investigate the occurrence of outbreaks of communicable diseases or clusters of infections; and (c) Reporting of infections, communicable diseases, and outbreaks to the local or State health department, as required by COMAR 10.06.01. (3) When an outbreak occurs, the infection control staff shall have adequate resources and authority to ensure comprehensive and timely investigation and to implement control measures. E. Education. (1) The hospital shall provide education to all staff and, if appropriate, to the patient and visitors regarding the prevention and control of communicable diseases and infections. Educational activities shall address problems identified by the infection prevention and control program. (2) Nonclinical staff shall be included in infection prevention and control training consistent with their assigned responsibilities. (3) Attendance or participation in an educational program shall be recorded. Educational programs shall be evaluated not less than annually for effectiveness. (4) Education related to infection prevention and control shall be included in the hospital's orientation program for all new employees, including appropriate contractual personnel. (5) Physicians who are employed or who have privileges and who do not receive training through the hospital's new employee training program shall receive alternative orientation education on infection prevention and control practices and the hospital's infection prevention and control program. (6) Outside agency staff shall receive sufficient training in the hospital's infection prevention and control policies and procedures to provide safe care to the patients. F. Prevention. (1) The hospital shall establish processes and programs to prevent the spread of communicable diseases and infections. (2) A hospital's processes and programs to prevent the spread of communicable diseases and infections shall include at least the items listed in §F(3) of this regulation. (3) Required Processes and Programs. (a) Hand Hygiene. (i) The infection prevention and control program shall include activities to educate staff on the need for hand hygiene prior to and after any patient contact and as directed by accepted professional practice. (ii) Hand hygiene compliance by staff shall be monitored through the infection prevention and control program. (iii) The infection prevention and control program shall maintain documentation of audits for compliance with this requirement. (iv) Facilities and supplies to facilitate hand hygiene shall be provided and be accessible in all locations of the hospital where patient care is provided. (b) Sanitation. (i) The hospital shall maintain a sanitary environment to prevent the spread of communicable diseases and infections. (ii) The hospital shall have systems to maintain the environment in a clean and sanitary condition. (iii) Systems shall be provided to ensure that housekeeping, linen handling, waste disposal including medical waste, food handling, ventilation systems, water systems, and pest control meet acceptable federal and State standards and guidelines. (c) Aseptic Technique. The hospital shall use aseptic techniques to prevent infections, including surgical site infections and device-associated infections. (d) Immunocompromised Patients. The hospital shall use professionally accepted procedures to protect immunocompromised patients from infection. (e) Standard Precautions. The hospital staff shall use standard precautions and other categories of isolation or precautions consistent with current Center for Disease Control (CDC) recommendations. (f) Equipment and Supplies. (i) The hospital shall have personal protective equipment, such as gloves, gowns, respirators, and masks or other facial protection for staff readily available. (ii) Supplies and equipment needed to prevent the spread of communicable diseases and infections shall be available in all patient care areas. (4) Employee Health Program. The infection prevention and control program shall work in conjunction with the employee health program and include monitoring and identification of employee health concerns such as immunity to measles, mumps, rubella, and varicella (chicken pox). (5) Immunizations for influenza shall be offered to staff and licensed independent practitioners. Reasons for refusal of the influenza vaccine by an employee shall be documented by the infection control or employee health program. G. Performance Improvement. (1) The infection prevention and control program shall include performance improvement and quality assurance measures to address the problems identified through the surveillance, control, and investigation of infections. (2) The hospital shall develop and implement interventions to address identified problems and monitor the effectiveness of interventions to control and prevent infections. (3) The infection prevention and control program shall be incorporated into the hospital's performance improvement program. H. Patient Safety. The infection prevention and control program shall share data regarding healthcare-associated infections with the hospital's designated patient safety officer. Health care associated infections that meet the definition of a Level 1 adverse event shall be reported to the Department, and a root cause analysis submitted as required by COMAR 10.07.06. I. Reports to the Governing Body. (1) Infection control data including reports on the numbers and types of healthcare-associated infections shall be reported to the hospital's medical staff and governing body on an ongoing basis. (2) The hospital leadership shall support infection prevention and control activities, including the provision of adequate resources for the program. J. Department Oversight. (1) The hospital shall comply with all data reporting requirements of the Maryland Health Care Commission related to the prevention and acquisition of infections in accordance with Health-General Article, §19-134(e), Annotated Code of Maryland. (2) The Department shall have access to all data maintained through the hospital's infection prevention and control program to determine the hospital's compliance with State and federal regulations. #### Regulation .35 Designation of Lay Caregivers. *COMAR 10.07.01.35* A. A hospital shall provide a patient or legal guardian of a patient with an opportunity to designate one lay caregiver before the discharge of the patient to their residence. B. The hospital’s discharge planning shall include the designation of the lay caregiver as soon as practicable in the discharge planning process. C. If a patient or legal guardian of a patient declines to designate a lay caregiver, the hospital shall: (1) Document the decision in the patient’s medical record; and (2) Be deemed to be in compliance with this regulation. D. If a patient or legal guardian of a patient designates a lay caregiver the hospital shall record in the patient’s medical record: (1) The designation of the lay caregiver; (2) The relationship of the lay caregiver to the patient; and (3) The name, telephone number, and address of the lay caregiver. E. Release of Medical Information. (1) If the patient designates a lay caregiver, the hospital shall request the patient or legal guardian to consent in writing to release medical information to the lay caregiver. The release of records shall be in accordance with: (a) The hospital’s procedures for releasing personal health information; and (b) All applicable federal and State laws. (2) If a patient or legal guardian of a patient declines to consent to the release of medical information to the lay caregiver, the hospital is not required to: (a) Provide to the lay caregiver the notice required under Health-General Article, §19-382, Annotated Code of Maryland; or (b) Consult with the lay caregiver or provide to the lay caregiver information contained in the discharge plan issued under Health-General Article, §19-383, Annotated Code of Maryland. F. A patient or a legal guardian of the patient may change the designation of a lay caregiver in the event the lay caregiver becomes incapacitated. G. Regardless of the desire of the patient or legal guardian of the patient, the designated lay caregiver is not obligated to perform any aftercare for the patient. H. A patient or legal guardian is not required to designate a lay caregiver. I. Hospital Obligations. (1) If a patient or legal guardian of a patient designates a lay caregiver, the hospital shall notify the lay caregiver as soon as practicable of the discharge of the patient or the patient’s transfer to another hospital, licensed health care facility or other residential facility. (2) As soon as practicable before the discharge of a patient, the hospital shall attempt to: (a) Consult with the patient’s lay caregiver to prepare the lay caregiver for the patient’s aftercare; and (b) Issue a discharge plan that describes the aftercare needs of the patient. (3) The hospital shall make reasonable attempts to consult with the lay caregiver. (4) The inability of the hospital to consult with a lay caregiver may not interfere with, delay, or otherwise affect the medical care provided to the patient or the patient’s planned discharge. (5) The hospital shall document successful or unsuccessful attempts to contact the lay caregiver. J. Discharge Planning Requirements. Regardless of the request for the designation of a lay caregiver, the hospital shall comply with all discharge planning requirements in: (1) Regulation .27 of this chapter; (2) The standards imposed under the hospital’s accreditation by a State-approved accreditation organization; and (3) 42 CFR §482.43. K. The designation of a lay caregiver may not: (1) Interfere with the rights of an agent to make health care decisions under Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland; or (2) Create a private right of action against a hospital, a hospital employee, or a duly authorized agent of a hospital or otherwise supersede or replace existing rights or remedies under any other State or federal law. #### Regulation .36 Patient Rights. *COMAR 10.07.01.36* A. A hospital shall develop a listing of the rights of patients that is consistent with the requirements of: (1) The Joint Commission; (2) Health-General Article, §19-342, Annotated Code of Maryland; and (3) 42 CFR §482.13. B. The hospital’s patient rights shall at minimum address: (1) Patient privacy and confidentiality; (2) Informed decision making and informed consent; (3) Visitation; (4) Advance directives; (5) Access to patient medical records; (6) Complaint and grievance process; (7) Freedom from: (a) Physical or mental abuse; (b) Neglect; (c) Harassment; or (d) Mistreatment; (8) A patient’s right to expect and receive appropriate assessment, management, and treatment of pain as an integral component of the patient’s care; and (9) Communication in a manner the patient can understand. C. All patients receiving services at the hospital, have the right to receive written copies of the hospital’s patient rights upon request. D. The hospital’s patient rights shall be easily accessible to patients and visitors. E. Hospital staff who are responsible for patient care shall: (1) Receive training regarding the hospital’s patient rights; and (2) Be able to assist patients and their families to: (a) Access the services of the hospital’s patient advocacy staff; (b) File a complaint or grievance; or (c) Obtain a written copy of the hospital’s patient rights documents. #### Regulation .37 Maryland Health Care Decisions Act. *COMAR 10.07.01.37* A hospital shall comply with the requirements of Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland. ### Chapter 02 — Nursing Homes **Authority:** Health-General Article, §§19-308, 19-308.1, 19-323, and 19-1401 et seq.;Public Safety Article, §14-110.1; Annotated Code of Maryland **Administrative History:** Effective date: June 30, 1978 (5:13 Md. R. 1053) **Administrative History:** This chapter is a compilation and revision of prior regulations contained in COMAR 10.07.02, Nursing Homes—Extended Care, and COMAR 10.07.05, Intermediate Care Facilities—Long-term Care (Type A). COMAR 10.07.02 was effective January 1, 1967; amended effective March 27, 1973 and April 16, 1975 (2:8 Md. R. 565). COMAR 10.07.05 was effective July 1, 1969 and amended effective March 27, 1973. **Administrative History:** Regulation .01B amended effective January 7, 1991 (17:26 Md. R. 2975); June 22, 1992 (19:12 Md. R. 1134); January 17, 1994 (21:1 Md. R. 33); August 15, 1994 (21:16 Md. R. 1383); June 30, 1997 (24:13 Md. R. 931); June 1, 1998 (25:11 Md. R. 821) **Administrative History:** Regulation .01B amended as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); amended permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulation .01B amended effective September 16, 2002 (29:18 Md. R. 1442); March 3, 2003 (30:4 Md. R. 316); September 13, 2004 (31:18 Md. R. 1350) **Administrative History:** Regulation .01I-1, L-1, O-1, GG-1 adopted effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .01GG-1, KK-1 adopted effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .01II-1 adopted effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .01-1 adopted effective June 1, 1998 (25:11 Md. R. 821) **Administrative History:** Regulation .01-1 amended effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .02 amended effective January 14, 1988 (15:1 Md. R. 20) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective May 10, 1993 (20:9 Md. R. 778) **Administrative History:** Regulation .02 amended effective August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Regulation .02F amended effective April 8, 1996 (23:7 Md. R. 551) **Administrative History:** Regulation .02G adopted effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .03 amended effective May 10, 1993 (20:9 Md. R. 778); August 27, 2007 (34:17 Md. R. 1507); August 24, 2009 (36:17 Md. R. 1312); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03A amended effective May 24, 1982 (9:10 Md. R. 1021); June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .03B amended effective August 1, 1994 (21:15 Md. R. 1304) **Administrative History:** Regulation .03-1 adopted effective May 10, 1993 (20:9 Md. R. 778) **Administrative History:** Regulation .04B amended effective December 7, 1992 (19:24 Md. R. 2125) **Administrative History:** Regulation .05 amended effective August 1, 2016 (43:15 Md. R. 864) **Administrative History:** Regulation .05B amended effective January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .05C amended effective January 25, 1980 (7:2 Md. R. 115) **Administrative History:** Regulation .07 amended effective January 26, 1987 (14:2 Md. R. 128); May 20, 1996 (23:10 Md. R. 731); August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Regulation .07A amended effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .07G amended effective May 24, 1982 (9:10 Md. R. 1021); January 26, 1987 (14:2 Md. R. 128); March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .07-1 adopted effective January 1, 2007 (33:26 Md. R. 1996) **Administrative History:** Regulation .08 amended effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .08A, B, D amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .08A, E amended effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .08-1 adopted effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .09A amended effective November 8, 1982 (9:22 Md. R. 2196); January 13, 1986 (13:1 Md. R. 16); January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .09B-1 adopted effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .09C, D amended effective August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Regulation .10 amended effective January 26, 1987 (14:2 Md. R. 128); June 30, 1997 (24:13 Md. R. 931) **Administrative History:** Regulation .10E amended effective November 8, 1982 (9:22 Md. R. 2196) **Administrative History:** Regulation .10H amended effective May 24, 1982 (9:10 Md. R. 1021) **Administrative History:** Regulation .10 repealed and new Regulation .10 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulation .11 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .11O amended effective November 8, 1982 (9:22 Md. R. 2196) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulation .11-1 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulation .11-2 adopted effective August 6, 2001 (28:15 Md. R. 1396) **Administrative History:** Regulations .12, .13, .18—.21 amended effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .12 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .13 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .14-1 adopted effective August 15, 1994 (21:16 Md. R. 1383) **Administrative History:** Regulation .14-2 adopted effective August 15, 1994 (21:16 Md. R. 1383) **Administrative History:** Regulation .15 amended effective January 26, 1987 (14:2 Md. R. 128); September 22, 2008 (35:19 Md. R. 1716) **Administrative History:** Regulation .15B amended effective March 16, 1992 (19:5 Md. R. 577); June 5, 1995 (22:11 Md. R. 820) **Administrative History:** Regulation .17 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .18B amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .19A, B amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .20 amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .21 amended effective June 1, 1998 (25:11 Md. R. 821) **Administrative History:** Regulation .21 repealed and new Regulation .21 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21E amended effective November 8, 1982 (9:22 Md. R. 2196) **Administrative History:** Regulation .21-1 adopted effective January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .21-1 repealed and new Regulation .21-1 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21-2 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21-3 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .21-4 adopted effective January 6, 2005 (31:26 Md. R. 1862) **Administrative History:** Regulation .22B amended effective August 3, 1981 (8:15 Md. R. 1306) **Administrative History:** Regulation .24 repealed and new Regulation .24 adopted effective April 21, 2008 (35:8 Md. R. 805) **Administrative History:** Regulation .26F amended and .26G—H repealed effective January 17, 1983 (10:1 Md. R. 28) **Administrative History:** Regulation .26EE amended effective October 25, 1982 (9:21 Md. R. 2106); September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .27A, B amended effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .27B amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .28 amended effective January 26, 1987 (14:2 Md. R. 128); January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .28C amended effective January 14, 1988 (15:1 Md. R. 20) **Administrative History:** Regulation .31A amended effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .32F amended effective January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .32G amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulation .33E amended effective January 26, 1987 (14:2 Md. R. 128) **Administrative History:** Regulations .35—.41 adopted effective January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .35 amended effective December 16, 1996 (23:25 Md. R. 1785) **Administrative History:** Regulation .36 amended effective December 16, 1996 (23:25 Md. R. 1785); September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .36C amended effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .37 amended effective December 16, 1996 (23:25 Md. R. 1785); September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .38 amended effective December 16, 1996 (23:25 Md. R. 1785) **Administrative History:** Regulation .39A and B amended effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulation .39C and D repealed effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulation .39G amended effective June 30, 1986 (13:13 Md. R. 1491) **Administrative History:** Regulation .40A amended effective June 30, 1986 (13:13 Md. R. 1491) **Administrative History:** Regulations .40 and .41 recodified to Regulations .43 and .44, respectively, Appendix recodified as Regulation .40 and amended, and new Regulations .41 and .42 adopted effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulation .41 repealed and new Regulation .41 adopted effective September 13, 2004 (31:18 Md. R. 1350) **Administrative History:** Regulation .41A amended effective August 1, 1994 (21:15 Md. R. 1304) **Administrative History:** Regulation .41D amended effective June 30, 1986 (13:13 Md. R. 1491) **Administrative History:** Regulation .43C adopted effective October 1, 1990 (17:19 Md. R. 2320) **Administrative History:** Regulations .45—.51 adopted effective January 7, 1991 (17:26 Md. R. 2975) **Administrative History:** Regulations .45—.51 repealed as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); repealed permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulations .45—.60 adopted as an emergency provision effective January 1, 2001 (28:4 Md. R. 414); adopted permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulation .49D amended effective September 16, 2002 (29:18 Md. R. 1442) **Administrative History:** Regulation .54D adopted effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .61 adopted effective August 24, 2009 (36:17 Md. R. 1312) **Administrative History:** Chapter revised effective June 17, 2019 (46:12 Md. R. 536) #### Regulation .01 Definitions. *COMAR 10.07.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrator” means the individual licensed by the Board of Examiners of Nursing Home Administrators who is responsible for the operation of the nursing home. (2) “Attending physician” means an individual licensed to practice medicine in the State who: (a) Admits residents to the nursing home; and (b) Is responsible for the overall care of a resident. (3) “Audiologist” means an individual who holds a Maryland license issued by the State Board of Audiologists, Hearing Aid Dealers, and Speech-Language Pathologists. (4) “Authorized prescriber” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland. (5) “Certified medicine aide” means an individual who meets the requirements as stated in COMAR 10.39.01 and 10.39.03. (6) “Certified social worker” means an individual licensed to practice as a certified social worker in this State. (7) “Charge nurse” means the registered or licensed practical nurse who is responsible for day-to-day operations of a unit in the nursing home on which residents live. (8) “Chemical restraint” means the administration of any drug that is used for discipline or convenience and not required to treat medical symptoms. (9) “Comprehensive care facility” means a nursing home that admits residents requiring medical services and nursing services rendered by or under the supervision of a registered nurse, who: (a) Are advanced in age; or (b) Have a disease or a disability. (10) “Concurrent review” means daily rounds by a licensed nurse which include: (a) Appraisal and observation of all residents by the licensed nurse to determine any change in each resident’s physical or mental status; (b) If there is a change in the resident’s physical or mental status, an evaluation by the licensed nurse of the resident’s medications, laboratory values relating to the resident, and clinical data relating to the resident, including the resident’s: (i) Hydration and nutritional needs; (ii) Skin integrity; (iii) Noted weight changes; and (iv) Appetite; (c) Evaluation of injuries sustained by the resident that result from an accident or incident involving the resident; and (d) Any other relevant parameters affecting or reflecting the resident’s physical and mental status. (11) “Culture change facility” means a nursing home where physical environment and operational changes have been made to establish person-valued and person-directed care activities and services. (12) “Deficiency” means a condition existing in a nursing home or an action or inaction by the nursing home staff that results in potential for more than minimal harm, actual harm, or serious and immediate threat to one or more residents. (13) “Dentist” means an individual licensed to practice dentistry in this State. (14) “Department” means the Maryland Department of Health. (15) “Dietetic service supervisor” means a person who: (a) Is a qualified dietitian; (b) Is a graduate of a dietetic technician program approved by the American Dietetic Association; (c) Is a certified dietary manager who has successfully completed the required course and maintains certification as required by the certifying board for the Dietary Managers Association; (d) Is a graduate of a State-approved course that provided 90 or more hours of classroom instruction in food service supervision and has experience as a supervisor in a health care institution with consultation from a dietitian; or (e) Has training and experience in food service supervision and management in a military service equivalent in content to §B(15)(b) and (d) of this regulation. (16) “Dietitian-nutritionist” means an individual who: (a) Is licensed by the Maryland Board of Dietetic Practice to practice dietetics; (b) Has met the certifying requirements for registration as a dietitian as administered by the Commission on Dietetic Registration; and (c) Maintains the continuing education requirements of registration. (17) “Discharge” means the removal of a resident from a nursing home when the releasing nursing home is no longer responsible for the resident’s care. (18) “Discipline” means the medical, rehabilitative, nursing, dietetic, activities and social service components affiliated with the operation of a nursing home. (19) “Distinct part extended care facility” means a portion of a nursing home that is licensed as an extended care facility. (20) “Extended care facility” means a nursing home that offers sub-acute care and provides medical treatment services for residents who require inpatient care but who do not currently require continuous hospital services. (21) “Facility” means a nursing home. (22) “Fire authorities” means the official fire safety agency including the State Fire Marshal or local fire marshals or fire departments as appropriate. (23) “Full time” means 40 hours per week or the standard work week adopted by the nursing home. (24) “Geriatric nursing assistant” means a CNA who has successfully completed the requirements for a GNA set forth in 42 CFR §§483.151—483.156 and COMAR 10.39.01. (25) “Grant” means the award of money to an individual or an organization to: (a) Study an aspect for the geriatric population; or (b) Provide a service to nursing home residents or their families. (26) “Health officer” means the health officer or the designated representative in each of the 23 counties and the Commissioner of Health in Baltimore City. (27) “HVAC” means heating, ventilation and air conditioning. (28) “Infection preventionist” means a licensed healthcare worker who: (a) Manages the infection prevention and control program in the nursing home; and (b) Has completed a minimum of 15 contact hours of infection prevention and control training that is approved by the: (i) Department’s Office of Infectious Disease Epidemiology and Outbreak Response; and (ii) Office of Health Care Quality. (29) “Licensed bachelor social worker (LBSW)” means an individual authorized to practice bachelor social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (30) “Licensed certified social worker (LCSW)” means an individual authorized to practice certified social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (31) “Licensed certified social worker–clinical (LCSW-C)” means an individual authorized to practice clinical social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (32) “Licensed master social worker” means an individual authorized to practice master social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (33) “Licensed or certified professional health care practitioner” means a nurse practitioner, physician assistant, or other practitioner licensed or certified under the Health Occupations Article, Annotated Code of Maryland. (34) “Licensed pharmacist” means an individual who is licensed by the Board to practice pharmacy as defined in Health Occupations Article, §12-101(l), Annotated Code of Maryland. (35) “Licensed practical nurse” means an individual authorized to practice licensed practical nursing under Health Occupations Article, Title 8, Annotated Code of Maryland. (36) “Management firm” means an organization, under contract with an applicant for a license or a current licensee, that is intended to have or has full responsibility and control for the day-to-day operations of the nursing home. (37) “MDS Care Area Assessment” means the investigation of triggered care areas, to determine if the care area or areas require interventions and care planning. (38) “Medical director” means an individual licensed to practice medicine in this State who, pursuant to a written agreement, is responsible for the overall coordination of the medical care in the nursing home to ensure the adequacy and appropriateness of the medical services provided to residents and to maintain surveillance of the health status of employees. (39) “Minimum Data Set (MDS)” means a core set of screening, clinical, and functional status elements, including common definitions and coding categories, which: (a) Forms the foundation of a comprehensive assessment for all nursing home and swing bed residents; and (b) Standardize communication about resident problems and conditions: (i) Within these facilities; (ii) Between these facilities; and (iii) Between these facilities and outside agencies. (40) “New nursing home” means a nursing home that does not yet have plans approved by the Department at the time of the adoption of this chapter. (41) “NFPA” means National Fire Protection Association. (42) “Nurse” means a licensed practical nurse or registered nurse licensed in the State as defined in Health Occupations Article, §8-101, Annotated Code of Maryland. (43) “Nurse practitioner” has the meaning stated in Health Occupations Article, §8-101(k), Annotated Code of Maryland. (44) “Nursing care” has the meaning stated in Health-General Article, §19-301(k), Annotated Code of Maryland. (45) “Nursing home” means a comprehensive care facility or extended care facility which offers nonacute inpatient care to residents: (a) Who have a disease, chronic illness, condition, disability of advanced age, or terminal disease requiring maximal nursing care without continuous hospital services; and (b) Who require medical services and nursing services rendered by or under the supervision of a licensed nurse together with convalescent, restorative, or rehabilitative services. (46) “Nursing service personnel” means staff licensed or certified by the Maryland Board of Nursing. (47) “Occupational therapist” means an individual who is licensed by the State Board of Occupational Therapy Practice to practice occupational therapy. (48) “Occupational therapy assistant” means an individual who is currently licensed by the State Board of Occupational Therapy Practice as an occupational therapy assistant. (49) “Ongoing pattern” means the occurrence of any potential for more than minimal harm or greater deficiency on two consecutive on-site visits as a result of: (a) Annual surveys; (b) Follow-up visits and unscheduled visits; or (c) Complaint investigations. (50) “Paid feeding assistant” means an individual who: (a) Meets the requirements of Regulation .63 of this chapter; and (b) Is paid by a nursing home to feed residents who are unable to perform the task themselves. (51) “Physical restraint” means any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body including but not limited to: (a) Leg restraints; (b) Arm restraints; (c) Hand mitts; (d) Soft ties or vests; (e) Lap cushions; and (f) Lap trays. (52) “Physical therapist” means an individual licensed to practice physical therapy by the State Board of Physical Therapy Examiners. (53) “Physician” means an individual licensed to practice medicine in this State. (54) “Physician assistant” has the meaning stated in Health Occupations Article, §15-101(o), Annotated Code of Maryland. (55) “Plan of correction” means a written response from the nursing home addressing each deficiency cited as a result of an inspection by the Department. (56) “Positive tuberculin skin test” means a test provided as authorized by the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. (57) “Principal physician” means an individual licensed to practice medicine in this State who agrees to perform certain medical services under contract with a nursing home, consistent with the policies of the nursing home. (58) “Protective device” means any device or equipment: (a) That is prescribed by a physician; (b) That limits, but does not eliminate the movement of the resident’s head, body, or limbs; and (c) That: (i) Shields a resident from self-injury; (ii) Prevents a resident from aggravating an existing physical problem; or (iii) Prevents a resident from precipitating a potential physical problem. (59) “Qualified medical record practitioner” means an individual who: (a) Has: (i) Received a baccalaureate degree from an accredited college or university including or supplemented by a successful completion of a course in health record administration approved by the Council on Medical Education of the American Medical Association; and (ii) Passed the national registration examination for registered record administrators; or (b) Has: (i) Received an associate of arts degree in health record technology from a college or university approved by the American Medical Association Council on Medical Education or an equivalent approved health record technology correspondence course of the American Medical Record Association; and (ii) Passed the national accreditation examination for accredited record technicians. (60) “Qualified social work consultant” means an individual who: (a) Is a licensed certified social worker; and (b) Has a minimum of 3 years’ experience in social work programs in a long-term care setting within the last 5 years. (61) “Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system” means the standard nationwide system to which several types of health care providers submit CMS required resident information to the National Submissions Database. (62) “Registered nurse” means an individual licensed to practice as a registered nurse in this State. (63) Relocation. (a) “Relocation” means the movement of a resident from one room to another within: (i) The same Medicare-certified nursing home; (ii) A Medicaid-only certified nursing home; or (iii) A licensed-only nursing home. (b) “Relocation” does not mean the movement of a resident if the effect of the movement is to move the resident from: (i) The distinct part of the nursing home that is a skilled nursing facility to a distinct part of the nursing home that is not a skilled nursing facility; or (ii) A bed that is certified for Medicaid to a distinct part of the nursing home that is a skilled nursing facility. (64) “Resident” means an individual who: (a) Resides in the nursing home; and (b) Receives nursing services rendered by or under the supervision of a registered nurse. (65) “Resident activities coordinator” means an individual who: (a) Is a: (i) Certified therapeutic recreation specialist; (ii) Licensed occupational therapist; or (iii) Licensed occupational therapy assistant; or (b) Has 2 years of experience in a social or recreational program in a licensed health care setting within the last 5 years, 1 year of which was full time in a resident activities program with guidance from an individual identified in §B(73)(a) of this regulation. (66) Resident Assessment Instrument (RAI). (a) “Resident Assessment Instrument (RAI)” means a standardized and reproducible resident assessment process based on completion of Minimum Data Set (MDS) screening items, and including the MDS Care Area Assessment process, and related process for care planning and evaluation. (b) “Resident Assessment Instrument (RAI)” includes: (i) Minimum Data Set; (ii) MDS Care Area Assessment Process; and (iii) RAI utilization guidelines. (67) “Resident’s representative” means a person with the authority to act on the resident’s behalf regarding the matter at issue. (68) “Restraint” means any physical or chemical restraint as defined in this chapter. (69) “Secretary” means the Secretary of Health. (70) “Serious and immediate threat” means a situation in which immediate corrective action is necessary because a deficiency has caused or is likely to cause serious injury, harm, impairment to, or death of a resident receiving care in the nursing home. (71) “Special care unit” means a nursing home unit that provides intensive specialized care, such as respiratory, rehabilitative, dementia, or dialysis care, continuously on a 24-hour basis. (72) “Speech-language pathologist” means an individual licensed by the State Board of Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists. (73) “Support personnel” means an aide who: (a) Is assigned to a particular service such as: (i) Nursing; (ii) Dietary; (iii) Physical therapy; or (iv) Occupational therapy; and (b) Has been approved by the manager of the services as having sufficient training and experience to perform the assigned duties. (74) “Tuberculin skin test” means a test to diagnose tuberculosis infection using purified protein derivative (PPD) that is injected intradermally and read within 48—72 hours with results recorded in millimeters of induration. (75) Tuberculosis in a Communicable Form. (a) “Tuberculosis in a communicable form” means that an individual: (i) Is presumed to have active pulmonary or laryngeal tuberculosis as evidenced by positive X-ray findings with or without positive acid-fast bacilli (AFB) sputum smear or positive AFB sputum culture; and (ii) Has received chemotherapy for less than 14 days. (b) “Tuberculosis in a communicable form” does not include: (i) When the individual who has presumptive or confirmed active disease, has had three negative AFB smears, collected 8—24 hours apart, shows clinical improvement, and has received chemotherapy to which the strain is susceptible for at least 14 days; or (ii) The individual who has inactive pulmonary scarring, calcification, or a normal chest X-ray. (76) “Two-step tuberculin skin testing” means the administration of a second tuberculin skin test 1 to 3 weeks after the initial skin test is negative, to identify individuals with a past TB infection who may now have reduced skin reactivity. #### Regulation .02 Incorporation by Reference. *COMAR 10.07.02.02* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual, (Version 1.14, October 2016). (2) CMS Manual System, Pub. 100-07 State Operations Provider Certification, (Transmittal 127, November 26, 2014, U.S. Department of Health and Human Services Centers for Medicare and Medicaid Services). (3) Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. (2014) Facility Guidelines Institute, which is incorporated in COMAR 10.07.01.02. (4) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (Centers for Disease Control and Prevention (CDC), Healthcare Infection Control Practices Advisory Committee (HIPAC), 2007). (5) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005 (MMWR2005; 54, No. RR-17, Centers for Disease Control and Prevention (CDC), Atlanta, GA). (6) Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP), (MMWR2011; 60 No. SS-07, Centers for Disease Control and Prevention (CDC), Atlanta, GA). (7) National Fire Protection Association, NFPA 99 Health Care Facilities Code (2015 Edition). (8) National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06. (9) Recommended Dietary Allowances, (10th Edition, Food and Nutritional Board, Commission on Life Sciences, and National Research Council, 1989). #### Regulation .03 License Required. *COMAR 10.07.02.03* A. A person may not establish, operate, or continue the operation of an existing comprehensive care facility or extended care facility without first obtaining a license from the Secretary. A license is valid for 2 years from the date of issuance, unless revoked by the Secretary. B. Separate License Required. Separate licenses are required for facilities maintained on separate premises, even though they are operated under the same management. Separate licenses may be required for separate buildings on the same grounds. C. Other License Required. A facility having a dual function, including care of the sick requiring hospital facilities in addition to rendering other care services, is required to be licensed for each level of health care rendered. D. Posting of License Application and Instructions for Written Comment. (1) At least 50 days before the anticipated date of the new license or relicensure, a facility shall conspicuously post: (a) Its application for initial license or license renewal; or (b) A notice describing where in the facility the application for licensure or relicensure may be found. (2) The posting shall be near the entrance, in a manner which is plainly visible and easily read by the public. (3) The posting shall include instructions for filing written comments to the Department. E. Posting of License. A facility shall conspicuously post its license on the premises, at or near the entrance, in a manner which is plainly visible and easily read by the public. F. Provisional License. (1) The Secretary may issue a license to a nursing home or an extended care facility for less than a 24-month period under any of the following conditions: (a) A facility has substantial deficiencies which in the opinion of the Department do not constitute a serious or immediate threat to the health, life, or safety of the residents and the facility has submitted a plan of correction to the Department which satisfactorily addresses the correction of each deficiency within a time frame acceptable to the Department; (b) A facility has substantial deficiencies which in the opinion of the Department have no immediate adverse effect on the life, safety, or health status of residents but require construction or remodeling to correct, and the facility has made a bona fide commitment to correct the deficiencies by a required date; (c) Departmental administrative delays have occurred which are beyond the control of the facility; (d) If new construction is completed to the point of being able to provide all necessary services to its residents but certain substantial items of equipment for optional services are temporarily lacking, which in the opinion of the Department will have no immediate adverse effect on the safety or health of its residents; or (e) Licensing revocation proceedings are pending against the facility. (2) A provisional license shall be based upon the facility's written plan of correction addressing every deficiency existing at the time of licensure, including specific corrective action with the anticipated date of correction for each deficiency. The Department's decision to issue a provisional license shall be based upon the reasonableness of the plan and the facility's compliance history. (3) The Secretary shall issue only one license of less than 24 months during a given licensure period unless the facility can demonstrate that extenuating circumstances exist which are beyond the control of the facility in meeting a required deadline or, where necessary, to allow the Department to coordinate and unify its annual licensing dates with federal certification dates. G. Waiver of Provisions. If a facility experiences practical difficulties or unnecessary hardships in complying with the provisions of this chapter, and can demonstrate that granting a waiver will not adversely affect the health and safety of its residents, the Secretary may waive any provision of this chapter. A waiver granted to a facility is effective for the period specified in the waiver. A waiver may be revoked at any time if a facility violates a condition of the waiver or if it appears to the Secretary that the health or safety of residents residing in the facility would be adversely affected by the continuation of the waiver. H. Plan of Correction Required. (1) A facility shall submit a written plan of correction to the Department within 10 working days of the date that a facility receives written notice of deficiencies from the Department. (2) The Department may not issue a license to a facility until the facility submits a plan of correction that is acceptable to the Department. #### Regulation .04 Licensing Procedure. *COMAR 10.07.02.04* A. Application for License. (1) An applicant desiring to open a comprehensive care facility or an extended care facility shall file an application with the Secretary, on a written or electronic form provided by the Secretary. (2) An application for a license shall be filed with the Department at least 60 days before the anticipated issuance of the license. (3) Applications on behalf of a legal entity shall be made by the senior officer or other senior official and a second official, if any. (4) All members of the governing body shall be disclosed, with their business addresses. (5) The applicant shall complete all disclosure required by the Secretary, including: (a) Ownership of real property; (b) The identity of any management company that will operate or contract with the applicant to operate the facility; (c) Ownership of equipment; and (d) The names of persons holding 5 percent or greater of stocks or assets. (6) The applicant for a license to operate a comprehensive care facility or an extended care facility is the licensee. Responsibility for conformance with licensing standards and regulations rests upon the licensee. Those licensees requesting participation in the Maryland Medicaid program shall comply with the Medicaid contract. (7) Additional Requirements. (a) The Secretary shall require an applicant for licensure to submit to the Secretary the following information concerning the applicant’s: (i) Past or current operation of a nursing home, other health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland, assisted living program, residential service agency or other licensed in-home care service, or licensed community program for individuals with developmental disabilities, substance abuse, or mental health needs, located within or outside this State; (ii) Ability to comply with the applicable standards of medical and nursing care and applicable State or federal laws and regulations by disclosing the identities of its medical director, director of nursing, and administrator, and by providing the nursing home’s quality assurance plan, as required in Regulation .66 of this chapter; and (iii) Financial and administrative ability to maintain a nursing home in compliance with these regulations, including submission of an audited financial statement, whether or not the applicant ever operated a nursing home, related institution, or other health care facility. (b) The Secretary shall: (i) Approve the application unconditionally; (ii) Approve the application with conditions, such as requiring the applicant to use the services of a management firm, requiring a staffing pattern, or limiting admissions to the facility; or (iii) Deny the application. (c) A person who disagrees with the decision of the Secretary to deny a license application under this section may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .78 of this chapter. B. Restrictions of License. (1) Nomenclature. A nursing home licensed under this regulation may not use the word “hospital” in its title. (2) Zoning. If a proposed facility is to be located in a political subdivision requiring zoning approval, the zoning authority's written approval shall be submitted to the Department before the Department's approval of the first drawings which are submitted. (3) Local Law or Ordinance, Where Applicable. A nursing home located in a political subdivision which requires it to meet certain standards shall submit proof to the Secretary that the nursing home meets local laws, regulations, or ordinances at the time application for license is submitted. (4) Transfer or Assignment of License. (a) If the sale, transfer, assignment, or lease of a nursing home causes a change in the person or persons who control or operate the nursing home, the nursing home shall be considered a “new nursing home” and the licensee shall conform to all regulations applicable at the time of transfer of operations. (b) The transfer of any stock which results in a change of the person or persons who control the nursing home, or a 25 percent or greater change in any form of ownership interest, constitutes a sale. (c) For purposes of Life Safety Code enforcement, the nursing home is considered to be an existing nursing home if it has been in continuous use as a nursing home. Waivers may be granted under Regulation .03F of this chapter. (5) Return of License to the Secretary of Health. The current license shall immediately become void and shall be returned to the Secretary if the: (a) Nursing home is sold, leased, or discontinued; (b) Operation moved to a new location; or (c) License is revoked. #### Regulation .05 Licensed Bed Capacity. *COMAR 10.07.02.05* A. A facility may exceed its licensed bed capacity only if the Department: (1) Requests that the facility exceed its licensed bed capacity; or (2) Approves a request from a facility to exceed its licensed bed capacity. B. Departmental Request of Facility to Exceed Capacity. If the Department requests a facility to exceed its licensed bed capacity, the written request is to include the: (1) Circumstances that prompted the Department to make the request; (2) Conditions under which the licensed bed capacity may be exceeded; and (3) Number of residents by which the facility's licensed capacity may be exceeded. C. Request for Departmental Permission to Exceed Capacity. (1) If an emergency situation exists, a facility may request permission from the Department to exceed its licensed bed capacity to help resolve the emergency situation. (2) The written request shall include the: (a) Circumstances or reasons for the request; (b) Identity of any resident involved; (c) Beginning and ending dates for which the request is made; and (d) Documentation of any objection by a resident affected by the request, or by the resident's personal representative. (3) The nursing home shall: (a) Submit the written request to the Office of Licensing and Certification Programs; and (b) Make the request for a term not to exceed 30 days. (4) Before reaching its decision on the request, the Department shall consider the: (a) Needs of the resident whose admission is proposed; (b) Ability of the facility to care for the resident properly; (c) Likely effect of the admission on the comfort and care of the other residents in the facility; and (d) Evidence that exceeding licensed capacity would help resolve the emergency situation. (5) Required Resident Accommodations. Before a facility may admit a resident that causes the facility to exceed its licensed bed capacity, the facility shall: (a) Provide the following equipment for the exclusive use of the resident: (i) Electronic nurses call system or hand bell, (ii) Privacy curtain or screen, (iii) Storage space for belongings, and (iv) A bed, at least 36 inches wide, sturdy and in good repair; (b) Meet any square footage requirements under this chapter for a room; and (c) Meet any other condition that the Department may require. (6) Admission. When a facility is permitted to exceed its licensed bed capacity under this section, the facility may not admit a resident to the facility until each resident admitted under permission granted under this section has: (a) Been placed in the facility as part of the facility's permanent resident population; or (b) Found other placement that is acceptable to the resident. #### Regulation .06 Rights of Applicant if License Denied or Revoked. *COMAR 10.07.02.06* A. Denial of License — Proposed Facility. The Secretary shall inform the applicant of the reasons for refusal to issue a license. B. Revocation of License. (1) The Secretary may, for cause shown, revoke or refuse to reissue any license issued by the Secretary. The Secretary shall consider the following factors in deciding whether a facility's license should be revoked: (a) The number, nature, and seriousness of the deficiencies; (b) The degree of risk to the residents posed by the deficiencies; (c) The compliance history of the facility; and (d) Background of the owner and management, including the owner's and management's experience in operating facilities and other businesses. (2) The licensee shall have the right to a hearing before revocation of the facility's license. The hearing shall be held after 10 days notice to the licensee, and the licensee shall have an opportunity to be represented by counsel at the hearing. #### Regulation .07 Inspection by Secretary. *COMAR 10.07.02.07* A. Open at all Times for Inspection. Licensed nursing homes and any premises that an applicant for a license proposes to operate shall be open at all times to inspection by the Secretary and by any agency designated by the Secretary. B. Site Visits and Surveys. (1) The Department shall make a site visit and conduct a full survey of each licensed nursing home at least once per calendar year. (2) All surveys shall be unannounced. C. Records and Reports. Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe and all these records and reports shall be open to inspection by the Secretary. Upon the written request of the Secretary or the Secretary's designee, the licensee shall provide immediately to the Secretary, photocopies of records and reports, including the clinical records of residents. The Department, upon request, shall reimburse the licensee for the cost of photocopying all records and reports requested under this section. D. The Secretary shall have the authority to immediately restrict admissions in accordance with the provisions of Health-General Article, §19-328, Annotated Code of Maryland. E. The Department shall make a site visit and conduct a full survey of each licensed nursing home at least once per calendar year. #### Regulation .08 New Construction, Conversion, Alteration, or Addition. *COMAR 10.07.02.08* A. Submission of Plans. (1) The architect or professional engineer of record shall submit stamped and sealed final construction drawings to the Department. (2) The architect or professional engineer of record shall submit a letter certifying that the project has been designed in accordance with all applicable federal, State, and local codes, laws, ordinances, and regulations for construction. B. Plan Approval. (1) A system of water supply, plumbing, sewerage, electrical power, garbage or refuse disposal may not be installed or extended until the architect or professional engineer of record submits stamped and sealed final construction drawings for Department record and provisional approval in accordance with §A of this regulation. (2) The architect or professional engineer of record shall also submit a letter certifying that the project has been designed in accordance with all applicable federal, State, and local codes, laws, ordinances, and regulations. C. New Construction. (1) A new nursing home shall satisfy the review of the Maryland Health Care Commission for the: (a) Establishment of a new nursing home; and (b) Increase or decrease in capacity of an existing nursing home. (2) After obtaining approval by the Maryland Health Care Commission, the nursing home shall provide written verification of the approval to the Office of Health Care Quality. (3) Verification shall include: (a) Details of the proposed nursing home changes; and (b) Written plans that describe how all residents, staff, and the general public will be kept safe for the duration of the project. D. Conversion, Alteration, and Additions. (1) An existing nursing home that wishes to convert, alter, modify, or add to the existing infrastructure shall notify the Office of Health Care Quality in writing. (2) The nursing home shall provide the Office of Health Care Quality with the documentation that verifies that the applicable local and State governmental authorities have approved work that was done. (3) The nursing home shall provide additional information upon request. #### Regulation .09 Administration and Resident Care. *COMAR 10.07.02.09* A. Responsibility. (1) The licensee shall be responsible for the overall conduct of the comprehensive care facility or extended care facility and for compliance with applicable laws and regulations. (2) The administrator shall be responsible for the implementation and enforcement of all provisions of the Patient's Bill of Rights Regulations under COMAR 10.07.09. B. Delegation to Administrator. (1) The licensee, if not acting as an administrator, shall appoint as administrator a responsible person who is: (a) Qualified by training and experience; and (b) Licensed by the Board of Examiners of Nursing Home Administrators for the State. (2) The administrator shall: (a) Be responsible for the control of the operation on a 24-hour basis; and (b) With the exception of §B(3) of this regulation, serve full-time. (3) With the Department’s approval, an administrator may serve on a less than full-time basis for a maximum of two nursing facilities, one of which shall have a licensed capacity of 35 beds or fewer. (4) The Department shall consider the following factors when deciding whether to approve an administrator to serve on a less than full-time basis: (a) Geographic location of the facilities; (b) Ownership of the facilities; (c) Organizational structure of the facilities; (d) Size of the facilities; and (e) Background and experience of the administrator. C. Absence of Administrator. (1) In the absence of the administrator, the nursing home at all times shall be under the direct and personal supervision of an experienced, trained, competent employee. (2) When serving as relief for the administrator, the director of nursing shall designate an experienced, qualified registered nurse to direct the nursing service. (3) The relief director of nursing shall be freed from other responsibilities. D. Excessive Absenteeism of Administrator. (1) If the director of nursing’s absence while covering for the administrator is having an adverse effect on resident care, the Department may require the designation of a specific registered nurse who shall be named the assistant director of nursing. (2) The Department shall be notified of the name of the assistant director of nursing. (3) When the designee is replaced, the Department shall be notified of the name of the registered nurse filling the vacancy. E. Character. The administrator shall: (1) Be of good moral character; (2) Be in good physical and mental health; and (3) Demonstrate a genuine interest in the well-being and welfare of residents in the nursing home. F. Staffing. (1) The administrator shall employ sufficient and satisfactory personnel as specified in this chapter to: (a) Provide maintenance, cleaning, and housekeeping; (b) Assist residents with eating; and (c) Give adequate resident care. (2) Voluntary Admissions Ceiling. (a) A nursing home may request a voluntary admissions ceiling by submitting a written request to the Department to authorize a temporary restriction on resident admissions based upon anticipated bed usage. (b) When the nursing home wishes to request that the restriction be removed, the request shall include the specific effective date and a statement that personnel staffing is sufficient to meet the State’s requirements at the designated census level. (c) The Department shall approve the increase in beds within 72 hours following receipt of the nursing home’s documentation that the required additional staff is in position to serve the increased number of beds. (d) Management of the nursing home may not permit the resident census to exceed the admissions ceiling without prior approval from the Department. G. Educational Program. (1) The administrator shall plan an ongoing educational program to develop and improve the skills of all the nursing home’s personnel, including training related to problems and needs of the aged, ill, and disabled. (2) The administrator shall maintain records reflecting attendance, by name and title, and training content. (3) In-service training shall include at least: (a) Prevention and control of infections; (b) Fire prevention programs and resident related safety procedures in emergency situations or conditions; (c) Accident prevention; (d) Confidentiality of resident information; (e) Preservation of resident dignity, including protection of the resident’s privacy and personal and property rights; (f) Physical, functional, and psychosocial needs of the aged ill individuals; (g) Receipt by each employee of appropriate orientation to the facility and its policies, and to the employee's position and duties; (h) Approval by the Department of the orientation and training programs. H. Employment Records. A written application shall be on file for each employee and shall contain at least the: (1) Employee’s Social Security number; (2) Home address; (3) Educational background; (4) Past employment documentation with references; (5) Past nursing home employment documentation, including any past instances of abuse of residents, theft, and fires; (6) Verified licensure of personnel employed; and (7) Proof of criminal background check. I. Support Personnel. (1) To support placement in a specific position, there shall be sufficient documentation in the employee’s record reflecting training and experience. (2) In instances when an aide is to be assigned to a particular service such as dietary, physical therapy, or occupational therapy, the person in charge of the service shall be responsible for evaluating and approving or disapproving the qualifications. J. New Support Personnel. (1) New support personnel shall be credited for 50 percent of their working time until the employee’s orientation program, as approved by the Department, is completed. (2) Employee Orientation Program. (a) New support personnel shall have an employee orientation program. (b) The person in charge of the service to which the employee is assigned shall: (i) Have input into the contents of the orientation program; (ii) Determine the number of hours of orientation required for the various levels of support personnel; and (iii) Following the period of orientation, indicate whether the employee satisfactorily completed the orientation program. (3) The responsible department’s approval shall be in writing, signed by the appropriate department head whose license number, if applicable, shall be recorded in the record. (4) In new facilities, the director of nursing and supervisors of dietary services, housekeeping, rehabilitation services, and social services shall be responsible for orienting the new support personnel to the nursing home policies and procedures and to the physical plant. (5) There shall be a complete orientation for all the employees in life safety and disaster preparedness. (6) The number of daily admissions of residents shall be controlled to allow sufficient time for on-the-job training. (7) Before the opening of the nursing home, support personnel shall have a minimum of 2 days of orientation training. K. Relief Personnel. Provision shall be made for qualified relief personnel during vacations or other relief periods. L. Availability of Information. The administrator shall make available to the Secretary such information as may be requested to insure that the facility is meeting the requirements of these and other applicable regulations. M. Except where inappropriate for safety reasons, an employee and any other individual who provides a health care service within or on the premises of the nursing home shall wear a personal identification tag that: (1) States the name of the individual; (2) States the profession or other title of the individual; and (3) Is in a readily visible type font and size. #### Regulation .10 Employee Training on Cognitive Impairment and Mental Illness. *COMAR 10.07.02.10* A. The following employees shall receive a minimum of 8 hours of training on cognitive impairment and mental illness within the first 90 days of employment: (1) Any employee who is licensed, certified, or registered under the Health Occupations Article, Annotated Code of Maryland; and (2) Any employee whose job duties include assisting residents with activities of daily living. B. The training on cognitive impairment and mental illness shall be designed to meet the specific needs of the nursing home’s population as determined by the staff trainer, including the following as appropriate: (1) An overview of the following: (a) A description of normal aging and conditions causing cognitive impairment; (b) A description of normal aging and conditions causing mental illness; (c) Risk factors for cognitive impairment; (d) Risk factors for mental illness; (e) Health conditions that affect cognitive impairment; (f) Health conditions that affect mental illness; (g) Early identification and intervention for cognitive impairment; (h) Early identification and intervention for mental illness; and (i) Procedures for reporting cognitive, behavioral, and mood changes; (2) Effective communication including: (a) The effect of cognitive impairment on expressive and receptive communication; (b) The effect of mental illness on expressive and receptive communication; (c) Effective verbal, non-verbal, tone and volume of voice, and word choice techniques; and (d) Environmental stimuli and influences on communication; (3) Behavioral interventions including: (a) Identifying and interpreting behavioral symptoms; (b) Problem solving for appropriate intervention; (c) Risk factors and safety precautions to protect the individual and other residents; and (d) De-escalation techniques; (4) Making activities meaningful including: (a) Understanding the therapeutic role of activities; (b) Creating opportunities for productive, leisure, and self-care activities; and (c) Structuring the day; (5) Staff and family interaction including: (a) Building a partnership for goal-directed care; (b) Understanding families' needs; and (c) Effective communication between family and staff; (6) End-of-life care including: (a) Pain management; (b) Providing comfort and dignity; and (c) Supporting the family; and (7) Managing staff stress including: (a) Understanding the impact of stress on job performance, staff relations, and overall facility environment; (b) Identification of stress triggers; (c) Self-care skills; (d) De-escalation techniques; and (e) Devising support systems and action plans. C. Employees who are not licensed, certified, or registered or who do not assist residents with activities of daily living shall receive a minimum of 2 hours of training on cognitive impairment and mental illness within the first 90 days of employment. The training shall include: (1) An overview of the following: (a) A description of normal aging and conditions causing cognitive impairment; (b) A description of normal aging and conditions causing mental illness; (c) Risk factors for cognitive impairment; (d) Risk factors for mental illness; (e) Health conditions that affect cognitive impairment; (f) Health conditions that affect mental illness; (g) Early identification and intervention for cognitive impairment; (h) Early identification and intervention for mental illness; and (i) Procedures for reporting cognitive, behavioral, and mood changes; (2) Effective communication including: (a) The effect of cognitive impairment on expressive and receptive communication; (b) The effect of mental illness on expressive and receptive communication; (c) Effective verbal, non-verbal, tone and volume of voice, and word choice techniques; and (d) Environmental stimuli and influences on communication; and (3) Behavioral intervention including risk factors and safety precautions to protect the individual and other residents. D. Ongoing training in cognitive impairment and mental illness shall be provided annually and consist of, at a minimum: (1) 2 hours for employees who are licensed, certified, or registered under the Health Occupations Article, Annotated Code of Maryland, or who assist residents with activities of daily living; and (2) 1 hour for all other employees. E. The training that is described in this chapter may be provided through various means including: (1) Classroom instruction; (2) In-service training; (3) Internet courses; (4) Correspondence courses; (5) Pre-recorded training; or (6) Other training methods. F. When the training method does not involve direct interaction between faculty and the participant, the facility shall make available to the participant during the training a trained individual to answer questions and respond to issues raised by the training. #### Regulation .11 Admission and Discharge. *COMAR 10.07.02.11* A. Written Policy. The nursing home shall develop written policies, consistent with this chapter and COMAR 10.07.09, to govern the nursing care, related medical, and other services that the nursing home provides regarding: (1) Admissions, transfers, and discharges; (2) Acceptable payment sources; and (3) Medical Assistance program information. B. The nursing home shall make its admission and discharge policies available for review by residents, the resident’s representative, and the long-term care ombudsman. C. Discrimination Prohibited. A nursing home licensed under this chapter may not discriminate in admitting or providing care to an individual because of the individual’s: (1) Race; (2) Color; (3) National origin; (4) Sexual orientation; (5) Gender identity; (6) Religion; (7) Physical disability; or (8) Mental disability. D. Contract. Before or at admission, a contract shall be executed by the administrator and resident, guardian, or responsible agency which is consistent with the requirements of Health-General Article, §19-344, Annotated Code of Maryland, “Rights of Individuals”. E. Registry. A nursing home shall maintain a permanent resident registry in which the name of each resident is entered in chronological order with the date and number of entry. F. Admission Record. A copy of the clinical record, identification, and summary sheet described in Regulation .32 shall be used as an admission record. G. Before discharge the nursing home shall: (1) Verify that the transfer and discharge is to a licensed assisted living facility and appropriate to meet the needs of the resident; and (2) Document the verification in the resident’s medical record. H. Notification of Responsible Persons When Resident Moves. When the resident is transferred from the nursing home for any reason or at time of death, the administrator or the administrator’s designee shall notify the attending physician and the: (1) Private agency; (2) Public agency; or (3) Responsible party designated by the resident. I. Restrictions on Admission and Retention of Residents. Residents may not be admitted or retained if, in the judgment of the attending physician, they are: (1) Acutely ill and require medical, surgical, or nursing care beyond the capabilities of the facility; or (2) Dangerous to themselves or others. #### Regulation .12 Resident's Representative. *COMAR 10.07.02.12* A. A nursing home shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements of Estates and Trusts Article, §13-601, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) To the extent permitted by Maryland law, any other individual, if that individual was designated by a resident who was competent at the time of designation. B. A facility shall require documentation or other appropriate verification of the authority of a resident's representative. A facility may not recognize the authority of a resident's representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. A facility shall: (1) Document in the resident's record the name of the individual, if any, with authority identified in §A of this regulation; or (2) Include the documentation in the record. #### Regulation .13 Resident Care Policies. *COMAR 10.07.02.13* A. A nursing home shall develop written policies consistent with Regulation .11 of this chapter pertaining to: (1) Physician services; (2) Residents’ rights; (3) Nursing services; (4) Dietetic services; (5) Specialized rehabilitative services including occupational therapy, physical therapy, speech pathology and audiology services; (6) Pharmaceutical services; (7) Laboratory and radiologic services; (8) Dental services; (9) Social services; (10) Resident activities; (11) Clinical records; (12) Reports and action required in unusual circumstances; (13) Utilization review; (14) Infection control; (15) Tuberculosis surveillance; (16) Disaster plan; (17) Housekeeping services, pest control, and laundry; and (18) Resident care management. B. Resident Care Policy. (1) A nursing home shall develop resident care policies with the advice of: (a) The principal physician or medical staff or medical director, if applicable; and (b) At least one registered nurse. (2) A group of professional personnel including one or more physicians and one or more registered nurses shall review the policies at least annually. (3) Written policies shall be kept current with the policies used to administer the nursing home. (4) For reference purposes, copies of the resident care policies shall be readily available to all personnel responsible for resident care. (5) The nursing home shall make its resident care policies available for review by residents, the resident’s representative, and the ombudsman. C. Policies and Procedures. (1) Upon the request of the Secretary or the Secretary's designee, the facility's policies and procedures shall be made available to the Secretary for onsite review. (2) The licensee shall submit to the Department any significant substantive changes to the policies and procedures which have occurred since review of the policies and procedures within 2 weeks of implementation of the changes. D. Use of Protective Device or Devices. (1) A written physician's order is required for the use of a protective device or devices. This order shall be in effect for a maximum of 60 days. If continuation of the use of a protective device or devices beyond 60 days is necessary, a new order shall be written by the physician and rewritten every 60 days. (2) The physician's order shall contain the specific type of protective device or devices to be used. (3) The physician's order shall reflect his or her reason for ordering a protective device or devices. (4) A resident in a protective device or devices shall be observed periodically by personnel, to ensure that the resident’s health and personal care needs are met. (5) A resident who is in a protective device or devices may not be left in the same postural position for more than 2 consecutive hours. #### Regulation .14 Physician Services. *COMAR 10.07.02.14* A. Responsibility for the Resident's Care. The attending physician shall: (1) Assess a new admission in a timely manner, based on a facility-developed protocol, depending on: (a) The individual's medical stability; (b) Recent and previous medical history; (c) Presence of significant or previously unidentified medical conditions; or (d) Problems that cannot be handled readily by phone; (2) Seek, provide, and analyze needed information regarding a resident's current status, recent history, and medications and treatments, to enable safe, effective continuing care and appropriate regulatory compliance; (3) Provide appropriate information and documentation to support a facility-determined level of care for a new admission; (4) Provide for the authorization of admission orders in a timely manner, based on a facility-developed protocol, to enable the nursing facility to provide safe, appropriate, and timely care; and (5) For a resident who is to be transferred to the care of another attending physician, continue to provide all necessary medical care and services pending transfer until another attending physician has accepted responsibility for the resident. B. Support Resident Discharges and Transfers. The attending physician shall: (1) Follow-up as needed with a physician or another health care practitioner at a receiving hospital within 24 hours of the transfer of an acutely ill or unstable resident; (2) Provide whatever summary or documentation may be needed at the time of transfer to enable care continuity at a receiving facility and to allow the nursing facility to meet its legal, regulatory, and clinical responsibilities for a discharged individual; and (3) Provide a pertinent medical discharge summary within 30 days of discharge or transfer of the resident. C. Periodic, Pertinent On-site Visits to Residents. The attending physician or licensed or certified professional health care practitioner shall: (1) Visit a resident as frequently as the resident's condition requires, consistent with reasonable facility policies; (2) Determine the progress of each resident's condition at the time of a visit by evaluating the resident, talking with staff as needed, and reviewing relevant information, as needed; (3) Review and respond to issues requiring a physician's expertise, including: (a) The resident's current condition; (b) The status of any acute episodes of illness since the last visit; (c) Test results; (d) Other actual or high-risk potential medical problems that may affect the individual's functional, physical, or cognitive status; and (e) Staff, resident, or family questions regarding the individual's care and treatments; and (4) At each visit, provide a legible progress note in a timely manner for placement on the chart, which includes relevant information about significant ongoing, active, or potential problems, including: (a) Reasons for changing or maintaining current treatments or medications; and (b) A plan to address relevant medical issues. D. Timeliness of Visits and Progress Notes. (1) Within 30 days of admission, a physician shall visit a resident, assess the resident's needs, and prescribe a regimen of medical care. After that, a physician, nurse practitioner, or physician assistant shall visit a resident every 30 days, except that a physician shall visit a resident at least every 120 days. (2) The timeliness of visits shall be based on a facility-developed protocol, depending on: (a) The resident's medical stability; (b) Recent and previous medical history; (c) The presence of significant or previously unidentified medical conditions; or (d) Problems that cannot be handled readily by phone. (3) The physician or licensed or certified professional health care practitioner shall maintain progress notes and make appropriate revisions to the resident's total program of care. The progress notes and revisions to the program of care shall cover, at a minimum, prognosis and changes in rehabilitation and other appropriate goals. The physician shall review and approve each program of care. E. Alternate Schedule. If the physician determines that the resident's condition requires less frequent visits than described in §D of this regulation, the physician may order an alternate schedule in the resident's medical record. An alternate schedule may not be ordered for the resident's first 90 days of stay. The alternate schedule may not exceed 60 days between visits. If there is no alternate schedule approved by the physician, visits may not exceed 30-day intervals. F. Adequate Ongoing Coverage. The attending physician shall: (1) Designate an alternate physician or physicians who shall respond in an appropriate, timely manner if the attending physician is unavailable; (2) Update the facility about the attending physician's current office address, phone, fax, and pager numbers to enable appropriate, timely communications, as well as the current office address, phone, fax, and pager numbers of designated alternate physicians; (3) Help ensure that alternate physicians provide adequate, timely support while covering and intervene with alternate physicians when informed of problems regarding coverage; and (4) Adequately inform alternate physicians about residents with active acute conditions or potential problems that may need medical follow-up during their on-call time. G. Appropriate Care of Residents. The attending physician shall: (1) Perform accurate, timely, and relevant medical assessments; (2) Properly define and describe resident symptoms and problems, clarify and verify diagnoses, relate diagnoses to resident problems, and help establish a realistic prognosis and care goals; (3) In consultation with the facility's staff: (a) Determine appropriate services and programs for a resident, consistent with diagnoses, condition, prognosis, and resident wishes; (b) Ensure that treatments are medically necessary and appropriate in accordance with nursing facility regulatory requirements; and (c) Manage and document ethics issues consistent with relevant laws and regulations and with residents' wishes, including advising residents and families about formulating advance directives or other care instructions and helping identify individuals for whom aggressive medical interventions may not be indicated; (4) Respond in an appropriate time frame, based on a facility-developed protocol, to emergency and routine notification, to enable the facility to meet its clinical and regulatory obligations; (5) Respond to notification of laboratory and other diagnostic test results in a timely manner, based on the resident's condition and clinical significance of the results; (6) Analyze the significance of abnormal test results that may reflect important changes in the resident's status and explain the medical rationale for interventions or decisions not to intervene based on those results; (7) Respond promptly to notification of, and assess and manage adequately, reported acute and other significant clinical condition changes in residents; (8) Ensure that individuals receiving palliative care have appropriate comfort and supportive care measures; and (9) Properly refer residents to specialty services and providers when the care needs of the resident exceed the scope of the attending physician’s knowledge and skill. H. Appropriate, Timely Medical Orders. The attending physician shall: (1) Provide timely medical orders based on an appropriate resident assessment, review of relevant pre-admission and post-admission information, and age-related and other pertinent risks of various medications and treatments; (2) Provide sufficiently clear, legible written medication orders to avoid misinterpretation and potential medication errors, including: (a) Medication strength and formulation, if alternate forms are available; (b) Route of administration; (c) Frequency and, if applicable, timing of administration; and (d) Reason for which the medication is being given; and (3) Institute safeguards to ensure the accuracy of verbal orders at the time the verbal orders are given and cosign the verbal orders in a timely fashion, but not later than the next visit to the resident. I. Appropriate, Timely, and Pertinent Documentation. The attending physician shall: (1) Provide documentation required to explain medical decisions, that promote effective care and allow a nursing facility to comply with relevant legal and regulatory requirements; and (2) Complete death certificates in a timely fashion, including all information required of a physician. #### Regulation .15 Medical Director — Qualifications. *COMAR 10.07.02.15* A. Medical Director Qualifications. The nursing home shall: (1) Designate a medical director who has at least the following qualifications: (a) A current license as a physician in this State; (b) At least 2 years of experience or specialized training in the medical care of geriatric or chronically ill and impaired residents; and (c) Successful completion of a curriculum in physician management or administration from: (i) AMDA: The Society for Post-Acute and Long-Term Care Medicine; or (ii) A curriculum approved by the Department or its designee; (2) Have a written agreement with a medical director that specifies the medical director's duties and roles and the authority to adequately discharge those responsibilities; and (3) Submit a copy of the medical director’s credentials to the Department upon a change in the medical director. B. The requirement specified in §A(1)(c) of this regulation becomes effective 3 years after the effective date of this regulation, but the medical director shall begin the educational process in physician management or administration within the first year from the date of employment as a medical director. #### Regulation .16 Medical Director — Responsibilities. *COMAR 10.07.02.16* A. General Responsibilities. The medical director is responsible for: (1) Overall coordination, execution, and monitoring of physician services; (2) Monitoring and evaluating the health care services and outcomes, including clinical and physician services provided to the nursing home’s residents; and (3) Designating an alternate medical director with sufficient training and experience to perform the responsibilities of the medical director as described in the regulations of this chapter. B. Practitioner Oversight. The medical director shall: (1) Oversee all physicians and other licensed or certified professional health care practitioners who provide health care to the facility's residents; (2) Ensure that there is a procedure for the review of the practitioners' credentials and the granting of privileges for licensed or certified professional health care practitioners who treat residents of the nursing facility; and (3) Recommend rules governing the performance of physicians and other licensed or certified professional health care practitioners who admit residents to the facility. C. Defining the Scope of Medical Services. (1) The medical director, in collaboration with the facility, shall recommend written policies and procedures that are approved by the licensee, delineating the scope of physician services and medical care. (2) The facility shall make these policies and procedures available to a resident or resident's representative upon admission and whenever a substantive change is made. D. Ensuring Physician Accountability. The medical director, in collaboration with the facility, shall recommend policies and procedures that cover essential physician responsibilities to the residents and the facility, including: (1) Accepting responsibility for the care of residents; (2) Supporting resident discharges and transfers; (3) Making periodic, pertinent resident visits in the facility; (4) Providing adequate ongoing medical coverage; (5) Providing appropriate resident care; (6) Providing appropriate, timely medical orders; (7) Providing appropriate, timely, and pertinent documentation; (8) Advising residents and families about formulating advance directives; and (9) Any other responsibilities as determined by the facility and the medical director. E. Quality Assurance. The medical director shall actively participate in the nursing home’s quality improvement process. Participation shall include: (1) Regular reports and attendance at the nursing home’s quality improvement committee meetings; and (2) Routine participation in ongoing facility efforts to improve the overall quality of the clinical care, including facility efforts to evaluate and address the causes of various care-related problems and deficiencies cited by the Office of Health Care Quality. F. Employee Health Oversight. The nursing home, in consultation with the medical director and other physicians, if necessary, shall establish and maintain surveillance of the health status of employees, including: (1) Advising on the development and execution of an employee health program, which shall include provisions for determining that employees are free of communicable diseases according to current accepted standards of practice; and (2) Ensuring that the facility plans and implements required immunization programs. G. Other Related Duties. The medical director shall perform other essential duties related to clinical care and physician practices, including: (1) Advising the administrator and the director of nursing on clinical issues, including the criteria for residents to be admitted, transferred, or discharged from the nursing facility; (2) Working with the nursing facility to establish appropriate relationships with area hospitals and other pertinent institutions to improve care of the residents; (3) Advising and consulting with the nursing facility staff regarding communicable diseases, infection control, and isolation procedures, and serving as a liaison with local health officials and public health agencies that have policies and programs that may affect the nursing facility's care and services to residents; (4) Providing or arranging for temporary physician services as needed to ensure that each resident has continuous physician coverage; (5) Participating as appropriate in facility committee projects and meetings concerning clinical care and quality improvement that require physician input; and (6) Educating or overseeing the education of, and informing, all attending physicians about their roles, responsibilities, and applicable rules and regulations. H. Medical Director Oversight Plan. (1) Based upon physician and medical director responsibilities in nursing facilities, as described in this chapter, the medical director shall develop and implement a plan describing how the medical director will carry out the responsibilities for the: (a) Overall monitoring, coordination, and execution of physician services and medical care to residents of the nursing facility; and (b) Systematic review of the quality of health care, including medical and physician services, provided to the facility's residents. (2) Minimum Requirements of the Plan. The medical director oversight plan shall include, at least, a plan to ensure that physicians: (a) Accept appropriate responsibility for residents under the physicians' care in the nursing facility; (b) Provide appropriate, timely medical care consistent with widely identified medical principles relevant to the facility's population; and (c) Provide appropriate, timely, and pertinent medical documentation and orders. (3) Documentation Regarding Medical Director Activities. (a) The medical director shall keep documentation regarding the medical director's activities in relation to designated responsibilities. (b) The documentation required in this subsection may include: (i) Notes; (ii) Minutes; (iii) Copies of faxes, letters, and telephone communications with attending physicians, other facility staff and departments, the administration, the governing body, and others regarding concerns, inquiries, and interventions. (c) The documentation required in this subsection shall show evidence of the medical director's interventions and follow-up of the effectiveness of those interventions. I. Quality Assurance Committee Minutes. Committee minutes shall reflect monthly input from the medical director regarding physician issues and general facility clinical care issues. #### Regulation .17 Nursing Home’s Responsibilities in Relation to the Nursing Home’s Medical Director. *COMAR 10.07.02.17* A. The nursing facility shall: (1) Be responsible for working with the medical director to ensure adequate resident care and practitioner performance; (2) Inform the physician of explicit requirements as a medical director and assist the medical director in gaining the necessary information and tools to properly execute those responsibilities; and (3) Ensure that the medical director has the necessary support and authority to perform medical director duties effectively and to hold practitioners accountable. B. When the attending physician and medical director document a resident’s medical need for a particular treatment, assistive device, or equipment, the nursing home shall provide that treatment, assistive device, or equipment unless the nursing home documents in the quality assurance committee minutes the reason or reasons why the treatment, assistive device, or equipment should not be provided. C. When the attending physician and medical director agree that a particular nursing home developed protocol is required to ensure that quality medical care is delivered to the nursing home’s residents, that protocol shall be implemented unless the nursing home documents in the nursing home’s resident care committee minutes the reason or reasons why the protocol should not be implemented. D. Evaluation of Medical Director's Performance. (1) The facility shall have a mechanism for evaluating the medical director's performance and for providing the medical director with feedback about that performance. (2) The criteria for evaluation shall be based on explicit medical director responsibilities and shall facilitate the medical director's improvement and performance of functions and duties. #### Regulation .18 Nursing Services. *COMAR 10.07.02.18* A. Organization, Policies, and Procedures. (1) Nursing service personnel shall provide care appropriate to the residents’ needs with the organizational plan, authority, functions, and duties clearly defined. (2) Nurses and support personnel shall be chosen for their training, experience, and ability. (3) Policies and procedures shall be adopted and made available to all nursing service personnel. B. Signed Agreement. (1) A signed copy of the agreement between the nursing home and the director of nursing, showing the license number of the nurse, shall be filed with the Department upon: (a) Application for an initial nursing home license; and (b) A change of director of nursing. (2) The agreement shall specify the duties of the director of nursing. C. Nursing Care 24 Hours a Day. The administrator shall employ sufficient and satisfactory licensed nursing service personnel and support personnel to: (1) Be on duty 24 hours a day; (2) Provide appropriate bedside care; and (3) Ensure that a resident: (a) Receives treatments, medications, and diet as prescribed; (b) Receives rehabilitative nursing care as needed; (c) Receives proper care to prevent pressure ulcers and deformities; (d) Is kept comfortable, clean, and well-groomed; (e) Is protected from accident, injury, and infection; (f) Is encouraged, assisted, and trained in self-care and group activities; and (g) Receives prompt and appropriate responses to requests for assistance. D. Assistance by Nursing Service Personnel. Nursing service personnel shall help the resident perform daily routine dental hygiene. E. Charge Nurse. (1) At least one licensed nurse shall be: (a) On duty at all times; and (b) Be designated by the director of nursing to be in charge of the nursing activities during each tour of duty. (2) The charge nurse or nurses shall have the ability to recognize significant changes in the condition of residents and to take necessary action. F. Charge Nurses’ Daily Rounds. The charge nurse or nurses shall make daily rounds on all nursing units for which they are responsible, performing such functions as: (1) Visiting each resident; (2) Reviewing clinical records, medication orders, resident care plans, and staff assignments; and (3) To the degree possible, accompanying physicians when visiting residents. G. Program of Restorative Nursing Care. There shall be an active program of restorative nursing care aimed at assisting each resident to achieve and maintain the individual’s highest level of independent function, including activities of daily living. This program shall include: (1) Ambulation and range of motion; (2) Maintaining good body alignment and proper positioning of bedfast residents; (3) Encouraging and assisting residents to change positions at least every 2 hours to stimulate circulation and prevent pressure ulcers and deformities; (4) Encouraging and assisting residents to keep active and out of bed for reasonable periods of time, within the limitations permitted by physicians’ orders; (5) Encouraging residents to engage in resident-chosen community and independent activities and achieve independence; and (6) Assisting residents to adjust to their disabilities and ensuring availability and use of their prosthetic and assistive devices. H. Coordination of Nursing and Dietetic Services. Nursing and dietetic services shall establish an effective policy to ensure that: (1) Nursing service personnel are aware of the nutritional needs and food and fluid intake of residents; (2) Nursing service personnel provide special meals and nourishment when required; (3) Residents’ food choices and preferences are honored as much as practical; (4) Nursing service personnel promptly aid residents when necessary in eating; (5) The dietetic service is informed of physicians’ diet orders and of residents’ nutrition-related issues; and (6) Food and fluid intake of residents is observed, and deviations from normal are recorded and reported to the: (a) Charge nurse; (b) Physician; and (c) Dietetic service. I. In-Service Education Program. (1) The director of nursing shall: (a) Provide a continuing in-service education program for all nursing service personnel; (b) Provide a thorough job orientation for new personnel; and (c) Document the content of the continuing in-service education program and include the names and titles of participants. (2) The director of nursing shall obtain approval from the Department. J. Responsibility to Report Care that Is Considered Questionable. (1) If a nurse questions the care provided to any resident or believes that appropriate consultation is needed and has not been obtained, the nurse shall inform the supervisor. (2) If indicated, the supervisor shall refer the matter to the director of nursing. (3) If warranted, the director of nursing shall report the matter to the medical director or principal physician. #### Regulation .19 Nursing Services — Staffing. *COMAR 10.07.02.19* A. Supervisory Personnel — Nursing Homes. (1) Nursing homes shall provide at least the following supervisory personnel: (2) The director of nursing’s time is included in §A(1) of this regulation. B. Hours of Bedside Care — Nursing Home. (1) A nursing home shall employ supervisory personnel and a sufficient number of support personnel to provide a minimum of 3 hours of bedside care per occupied bed per day, 7 days per week. (2) Bedside hours include the care provided by: (a) Registered nurses; (b) Licensed practical nurses; and (c) Support personnel. (3) Only those hours which the director of nursing spends in bedside care may be counted in the 3-hour minimum requirement. (4) The director of nursing’s time counted in bedside care shall be documented. C. Staffing in Nursing Home. (1) A nursing home shall be staffed with at least one registered nurse, 24 hours per day and 7 days per week. (2) Additional registered nurses, licensed practical nurses, and support personnel shall be employed to meet the needs of all the residents admitted. The nursing home shall be staffed as referenced in §§A and B of this regulation. D. Nursing Service Personnel on Duty. The ratio of nursing service personnel on duty providing bedside care to residents may not at any time be less than one to 15. #### Regulation .20 Nursing Services — Director of Nursing. *COMAR 10.07.02.20* A. Director of Nursing. The nursing home shall provide for an organized nursing service, under the direction of a full-time registered nurse. B. Termination of Services of Director of Nursing. (1) If the nursing home terminates the services of the director of nursing, the nursing home immediately shall notify the Department of the termination. (2) The name and license number of the replacement director of nursing shall be supplied to the Department as soon as employment begins. (3) A copy of the agreement between the nursing home and the replacement shall be sent to the Department. C. Director of Nursing’s Vacancy Exceeding 30 Days. If the position of director of nursing remains vacant for a period exceeding 30 days, the nursing home’s license may be revoked unless the administrator and the governing body are able to demonstrate that they have made every effort to obtain a replacement. D. Relief for Director of Nursing. (1) When the director of nursing is absent, the individual shall designate an experienced, qualified registered nurse to direct the nursing service. (2) In a nursing home in which the director of nursing serves as relief for the administrator, the director of nursing shall designate a specific registered nurse who shall be in charge of the nursing service while the director of nursing covers for the administrator. E. Responsibilities of the Director of Nursing. The responsibilities of the director of nursing shall include: (1) Assisting in the development and updating of statements of nursing philosophy and objectives to define the type of nursing care the nursing home shall provide; (2) Preparation of written job descriptions for nursing service personnel; (3) Planning to meet the total nursing needs of residents to be met and recommending the assignment of a sufficient number of supervisory and support personnel for each tour of duty; (4) Development and maintenance of nursing service policies and procedures to implement the program of care; (5) Participation in the coordination of resident services through appropriate staff committee meetings on issues relating to: (a) Pharmacy; (b) Infection control; (c) Resident care policies; (d) Quality assurance programs; and (e) Departmental meetings; (6) Cooperation with administration in planning the orientation program and the staff development program to upgrade the competency of personnel; (7) Ensuring that nursing personnel understand the philosophy and meet the objectives; (8) Participation in planning and budgeting for nursing services; (9) Establishment of a procedure to ensure that nursing service personnel, including private duty nurses, have valid and current Maryland licenses; (10) Execution of resident care policies unless delegated to the principal physician or medical director; (11) Participation in the selection of prospective admissions to ensure that the nursing home’s staff is capable of meeting the needs of all residents admitted; (12) Coordination of the interdisciplinary resident care management efforts; and (13) Supervision of certified medicine aides to ensure that the aides act within the limitations and restrictions placed on them. F. Delegation of Responsibilities. The director of nursing shall make clear any authority delegated to another staff member. G. Daily Rounds — Director of Nursing. (1) Although daily rounds are primarily the responsibility of the charge nurse or nurses, the director or assistant director of nursing shall periodically make clinical rounds to nursing units, randomly reviewing clinical records, medication orders, resident care plans, and staff assignments and visiting residents. (2) Upon request, the director or assistant director of nursing may accompany physicians visiting residents. H. Director of Nursing’s Continuing Education. The director of nursing shall assume responsibility for maintaining professional competence of staff through their participation in education programs. #### Regulation .21 Dietetic Services. *COMAR 10.07.02.21* A. Services Provided. Services may be provided directly by the facility or the facility may contract with a food management company, a caterer, or another facility. The facility and the food management company (or caterer or facility providing service) shall comply with these regulations. Food service personnel shall comply with COMAR 10.15.03 Food Service Facilities. B. Supervision. (1) In a nursing home with more than 50 beds, overall supervisory responsibilities for the food service department and food production shall be assigned to a full-time qualified dietetic service supervisor. It shall be the responsibility of the supervisor to delegate relief duties to an individual qualified to serve as relief as stated in Regulation .09I of this chapter. (2) In a nursing home with 50 or fewer beds, exceptions may be made by the Department to allow the supervisor to share cooking responsibilities with the full-time cook. C. Consultation. (1) If the supervisor is not a licensed registered dietitian, the individual shall receive regularly scheduled consultation from a licensed registered dietitian. In all instances sufficient consultation shall be provided to fulfill all required responsibilities. (2) There shall be a signed agreement between the facility and the consultant dietitian specifying hours and frequency of service responsibilities, and registration number if applicable. (3) Consultation services shall be documented by written reports. D. Staffing. (1) A sufficient number of food service personnel shall be employed to perform efficiently the functions of the food and nutrition service and meet the dietary needs of the residents. (2) Working hours shall be scheduled to ensure that the nutritional needs of the residents are met. (3) Nursing, housekeeping, laundry, or other personnel may not be used as food service staff. Exceptions, such as in a culture change setting, shall be based on the written approval of the Department. The kitchen may not be used for any purpose other than the preparation of food. E. Adequacy of Diet. (1) The food and nutritional needs of residents shall be met in accordance with physicians’ orders. (2) To the extent medically possible, the “Recommended Dietary Allowances” of the Food and Nutrition Board, Commission on Life Sciences, and National Research Council, adjusted for age, sex, and activity, shall be observed. (3) The “Diet Manual for Long-Term Care Residents”, as published by the Department, or any other similar reference material that contains food allowances and guides for regular and therapeutic diets, shall be used. F. Therapeutic Diets. Therapeutic diets shall be planned, prepared, and served as prescribed by the attending physician: (1) Therapeutic diets shall be planned by a licensed registered dietitian; (2) Preparation and serving shall be supervised by a qualified dietetic supervisor; and (3) A current diet manual shall be available to medical, nursing, and dietetic staff. G. Frequency and Quality of Meals. (1) At least three meals or their equivalent shall be offered daily, at regular times, with not more than 14-hour intervals between the substantial evening meal and breakfast. (2) A substantial evening meal is an offering of three or more menu items at one time, one of which includes a high quality protein such as meat, fish, eggs, or cheese. This meal represents at least 20 percent of the day’s total nutritional requirements. (3) To the extent medical orders permit, bedtime nourishments shall be offered routinely to all residents. (4) If a four or five meal a day plan is used, the meal pattern to provide this plan shall be approved by the Department. H. Advance Planning and Posting of Menus. (1) Residents shall be given the opportunity to participate in planning menus. Menus shall be written at least 1 week in advance. (2) The current week’s basic menu shall be posted in one or more easily accessible places in the food services department and in the common areas. (3) Menus shall include alternatives of similar nutritive value that give residents the opportunity to choose meals that they prefer. The dietary preferences of a resident shall be ascertained, including preferences arising from a resident’s religious, cultural, and ethnic heritage, and efforts shall be made to meet those preferences. I. Menus Served as Planned. Food sufficient to meet the nutritional needs of patients shall be prepared as planned for each meal. When menu changes are necessary, substitutions shall provide equal nutritional value. J. Retention of Records. Menus as served and records of food purchased for consumption by patients shall be filed on the premises for a period of 30 days. K. Preparation of Food. (1) Foods shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at proper temperatures, in a form to meet individual needs. (2) Standardized recipes adjusted to appropriate yield shall be followed. Standardized recipes are those recipes which have been tested by the nursing home or another source and that ensure consistent quality and quantity. L. Resident-Directed Meal Pattern. If a resident-directed meal pattern is provided, the following is required: (1) Counseling the residents regarding the risks and benefits of a resident-selected diet which is documented within the medical record; and (2) Approval of the pattern by both the resident’s physician and a licensed registered dietitian. #### Regulation .22 Specialized Rehabilitative Services — Occupational Therapy Services, Physical Therapy Services, Speech Pathology and Audiology Services. *COMAR 10.07.02.22* A. Rehabilitative Services — Admission Policies. In a nursing home which does not accept residents in need of specialized rehabilitative services, the minimal acceptable restorative service shall be the restorative nursing care plan designed to maintain function or improve the resident’s ability to carry out activities of daily living as set forth in Regulation .18G, of this chapter. B. Arrangements for Services. (1) If a nursing home’s admission policies include the admission of residents requiring rehabilitative services, the nursing home shall provide, or arrange for under written agreement, specialized rehabilitative services by qualified personnel, such as a physical therapist, speech-language pathologist and audiologist, and occupational therapist. (2) Initiation of services to meet the rehabilitative needs of the resident shall occur within 48 hours, excluding Saturday, Sunday, and State and federal holidays, of the physician’s order for the specialized service. (3) The resident may not be accepted for admission if at least one service to meet the rehabilitative needs of the resident cannot be initiated within the 48-hour period, excluding Saturday, Sunday, and State and federal holidays. C. Policies and Procedures. (1) Written administrative and resident care policies and procedures shall be developed for rehabilitative services by appropriate rehabilitation team members and representatives of the medical, administrative, and nursing staff. (2) Policies shall provide for the coordination of rehabilitative services and the rehabilitative aspects of nursing. (3) The nursing home shall make its administrative and resident care policies available for review by residents and the resident’s representative. D. Written Plan of Care. Rehabilitative services shall be provided under a written plan of care, initiated by the attending physician, and developed in consultation with appropriate rehabilitation team members and the nursing service. E. Physician’s Orders. (1) Specialized rehabilitative services shall be provided only on written orders of the attending physician. (2) Orders shall include modalities to be used, frequency, and anticipated goals and shall be made a part of the resident care plan. (3) The physician shall review with the resident or the family or resident’s representative the goals and the treatment program. The frequency of communications between the physician and the rehabilitation team members shall depend on changes in the resident and the resident’s medical status. F. Progress Notes. (1) Within 2 weeks of referral to specialized rehabilitative services, the rehabilitation team members shall provide the attending physician with a written report of the evaluation, including goals and progress of the resident. (2) Progress notes related to rehabilitative services shall be written at least every 2 weeks. G. Reevaluation of Resident’s Progress. (1) The physician and the rehabilitation team members shall reevaluate the resident’s progress as necessary, but at least every 30 days. (2) The physician may document on the record that the reevaluation may be less frequent but in no case may the reevaluation exceed 60 days. H. Resident’s Record. (1) The physician’s orders, the initial evaluations, the plan of rehabilitative care, goals, services rendered, evaluations of progress, and other pertinent information shall be: (a) Recorded in the resident’s medical record; and (b) Dated and signed by the: (i) Physician ordering the service; and (ii) Those disciplines who provided the service. (2) The record and progress notes concerning the resident shall reflect at all times the most recent and current status of the resident, including current short-term and long-term goals. I. Proof of Licensure. The facility shall maintain a file which includes proof of current licensure of all the rehabilitative services' personnel. J. Job Descriptions. Current job descriptions for all rehabilitative services personnel shall be readily available in the facility. #### Regulation .23 Special Care Units — General. *COMAR 10.07.02.23* A. A nursing home which holds a current and valid operating license may establish special care units with the approval of the: (1) Office of Health Care Quality; and (2) Department’s Office of Capital Planning, Budgeting and Engineering Services. B. A facility may notify the Department of its intention to establish a special care unit before developing and submitting the required documents for approval as described in §C of this regulation. C. The nursing home shall obtain Departmental approval of the following pertaining to the special care unit: (1) A description and scope of services to be provided; (2) An organization chart of the special care unit and its relationship to the rest of the nursing home; (3) A description of staffing patterns; (4) Qualifications, duties, and responsibilities of personnel; (5) A quality assurance plan which includes: (a) Assignment of responsibility for monitoring and evaluation activities; (b) Identification of the predominant aspects of care provided; (c) Identification of indicators and appropriate clinical criteria for monitoring the most important aspects of care; (d) Establishment of thresholds (levels or trends) for the indicators that will trigger evaluation of care; (e) Monitoring of the important aspects of care by collecting and organizing data for each indicator; (f) Evaluation of care when thresholds are reached in order to identify opportunities to improve either care or problems; (g) Taking actions to improve care or to correct the problems; (h) Assessing the effectiveness of the actions, documenting the improvement in care, and assessing the quality assurance process; and (i) Communication of the results of the monitoring and evaluation process to relevant individuals or services; (6) Policies and procedures, including: (a) The transfer or referral of residents who require services that are not provided by the special care unit; (b) The administration of medications that are relevant to the special care residents in the special care units; (c) Infection control measures to minimize the transfer of infection in the special care unit; (d) Pertinent safety practices, including the control of fire and mechanical hazards; and (e) Preventive maintenance for equipment in the special care unit; (7) Protocols for obtaining specialized services, such as arterial blood gases or other STAT services; (8) Protocols for emergency situations; and (9) An inventory of any specialized equipment to be housed on the unit to provide services in the special care unit. D. A facility that has been approved to establish a special care unit shall meet all applicable requirements of this chapter. E. Physician Coordinator. (1) If the facility's medical director does not have special training and experience in the discipline of the assigned special care unit, the facility shall hire a physician who is appropriately trained and experienced to provide: (a) Overall medical supervision of the special care unit; and (b) Coordination of all services for the assigned special care unit. (2) The facility shall verify the candidate's credentials before employment as physician coordinator. (3) The physician coordinator, or a designee who meets the requirements of §E(1) of this regulation, shall: (a) Respond personally or arrange for another qualified physician to respond to situations warranting medical intervention; and (b) Be available to provide any required consultation. F. Staffing. The nursing home shall ensure that each unit is sufficiently staffed with qualified personnel to provide appropriate treatment and meet the care needs of the residents. G. Nursing Services. (1) The director of nursing shall designate a registered nurse who has education, training, and experience in caring for the needs of the special care residents to coordinate all nursing care within the special care unit. (2) Nursing staff shall be: (a) Knowledgeable about the emotional and rehabilitative aspects of the special care unit residents; and (b) Capable of initiating appropriate therapeutic interventions when needed. H. Design. (1) A special care unit shall meet the general construction requirements of Regulations .08, .42, and .41 of this chapter, and the requirements in this regulation. (2) The nursing home shall ensure that floor space allocated to each bed meets minimum requirements listed in Regulation .49 of this chapter, and is sufficient to accommodate the special equipment necessary to meet the needs of residents. I. Radiologic and Laboratory Services. The facility shall ensure that diagnostic radiologic and clinical laboratory services are available 24 hours a day. The services may be provided through contractual arrangements with providers that meet applicable federal and State laws and regulations. J. Quality Assurance Program. The facility shall: (1) Develop a quality assurance plan to monitor and evaluate the care provided in each special care unit; and (2) Monitor and evaluate the quality and appropriateness of care provided by the special care unit as part of the facility's overall quality assurance program. #### Regulation .24 Special Care Units — Respiratory Care Unit. *COMAR 10.07.02.24* A. A respiratory care unit shall meet the: (1) General requirements established for all special care units as outlined in Regulation .23 of this chapter; and (2) Requirements of this regulation. B. The nursing home shall submit to the Department and obtain approval of the following: (1) All documents required in Regulation .23 of this chapter; (2) Policies and procedures for all aspects of care as outlined in Regulation .23 of this chapter, and the following: (a) Qualifications, duties, and responsibilities of staff, including the staff who are permitted to perform the following procedures: (i) Cardiopulmonary resuscitation; (ii) Obtaining arterial blood gas samples and their analyses; (iii) Pulmonary function testing; (iv) Therapeutic chest percussion and vibration; (v) Bronchopulmonary drainage; (vi) Coughing and breathing exercises; (vii) Mechanical ventilatory and oxygenation support for residents; and (viii) Aerosol, humidification, and medical gas administration; (b) Weaning from mechanical ventilatory support and discharge planning for residents of the respiratory care unit; and (c) The procurement, handling, storage, and dispensing of medical gases. C. Physician Coordinator. If the nursing home’s medical director does not have special training and experience in diagnosing, treating, and assessing respiratory problems, the nursing home shall employ or contract with a Board-certified pulmonologist who has the special knowledge and experience to provide: (1) Overall medical supervision of the respiratory care unit; and (2) Coordination of all services for the respiratory care unit. D. Staffing. The nursing home shall ensure that: (1) The nurse manager or the director of nursing of vent units has a background in ventilator care or is qualified in ventilator management; (2) Respiratory care services are provided by a sufficient number of qualified personnel; and (3) Respiratory care personnel provide respiratory care services commensurate with their documented training, experience, and competence. E. Design. (1) Emergency Power. The nursing home unit shall meet all applicable requirements in Regulation .46 of this chapter for emergency electrical power, including the provision of: (a) Emergency lighting in the respiratory care unit where life support equipment is used; and (b) Duplex receptacles connected to the facility's emergency generator to provide emergency power to operate life support equipment and nonflammable medical gas systems in the respiratory care unit. (2) Ventilator Alarms. The facility shall ensure that each ventilator is equipped with an alarm on both the pressure valve and the volume valve for safety. (3) Piped Medical Gas Systems. (a) To service the medical gas systems, a vendor or staff shall be trained and accredited in accordance with NFPA 99 Health Care Facilities Code. (b) The vendor or staff may provide the following services: (i) Installation; (ii) Inspection; or (iii) Testing. (c) The nursing home shall ensure that all piped medical gas systems adhere to the following standards: (i) NFPA 99 Health Care Facilities Code; and (ii) NFPA 101 Life Safety Code. F. The nursing home shall provide pulmonary function testing and blood gas or pulse analysis capability on-site or through contractual arrangements with providers who meet applicable State and federal laws and regulations. G. Contractual Services. When any respiratory care services are provided by an outside contractor, the facility shall: (1) Approve the contractor based on the contractor's credentials, training, and experience; (2) Ensure that all contractors: (a) Provide services 24 hours a day; (b) Meet all safety requirements; (c) Abide by all pertinent policies and procedures of the facility; (d) Provide services in accordance with all laws and regulations governing the facility; and (e) Participate in the monitoring and evaluation of the appropriateness of services provided as required by the facility's quality assurance program; and (3) Ensure that all contractual services receive overall medical supervision and coordination by the facility's physician coordinator of the respiratory care unit. #### Regulation .25 Special Care Units — Dementia Care Unit. *COMAR 10.07.02.25* A. A dementia care unit shall meet the: (1) General requirements established for all special care units as outlined in Regulation .24 of this chapter; and (2) Requirements of this regulation. B. Dementia Unit Disclosure. (1) The disclosure shall be made to the Department and to any person seeking placement or receiving care in a Dementia special care unit or program of a nursing home. (2) The information disclosed shall explain the additional care provided in each of the following areas: (a) The Dementia special care unit’s written statement of its overall philosophy and mission, which reflects the needs of residents with dementia; (b) The process and criteria for placement, transfer, or discharge from the unit; (c) The process used for individualized assessment and establishing the resident-centered plan of care and its implementation, including the method by which the plan of care evolves and is responsive to changes in the individual’s condition; (d) Staff training and continuing education practices; (e) The physical environment and design features appropriate to support the functioning of cognitively impaired adult residents; (f) The frequency and types of resident activities; (g) The involvement of families and family support programs; and (h) The cost of care and any additional fees. C. Secured units shall meet the established standards applicable to nursing home set forth in NFPA 99 Health Care Facilities Code and NFPA 101 Life Safety Code. #### Regulation .26 Pharmaceutical Services. *COMAR 10.07.02.26* A. Definition. In this regulation, the term “committee” means the pharmaceutical services committee. B. Duties of the Nursing Home. (1) The nursing home shall provide appropriate methods and procedures for administering drugs and biologicals to the nursing home’s residents. (2) The nursing home shall provide pharmaceutical services in accordance with accepted professional standards and related federal, State, and local laws. C. Duties of the Pharmaceutical Services Committee. (1) A pharmaceutical services committee, or its equivalent, shall develop written policies and procedures for safe and effective drug therapy, distribution, control, and use. (2) The composition of the committee shall include at least: (a) The licensed pharmacist; (b) The director of nursing; (c) The consultant dietitian-nutritionist; (d) One physician; and (e) The administrator. (3) The committee shall meet at least quarterly to establish policies and procedures. (4) There shall be an agenda to guide meeting participants. (5) All members of the committee shall review revisions of policies and procedures before implementing any changes. (6) The pharmaceutical services committee may not develop policies and procedures that prohibit or restrict a resident from receiving medications from the pharmacy of the resident’s choice. (7) In cases where the cost of any medication obtained from the pharmacy selected by the resident exceeds the cost of the same or equivalent medication available through a pharmacy that the nursing home has contracted with to provide pharmaceutical services, the resident shall be responsible for the additional amount. (8) The committee may not require the pharmacy to provide drugs by way of a specific drug distribution system such as unit dose or use of a particular packaging system. (9) The committee shall establish the contents of sealed emergency drug kits. (10) The committee shall oversee the accuracy and adequacy of pharmaceutical services to the nursing home. (11) The committee shall make recommendations for improvements to pharmaceutical services. (12) The committee shall document its actions and recommendations. D. Labeling. (1) Medications shall be accurately and plainly labeled. Except for those over-the-counter medications that the Department may list as suitable for purchasing in bulk and dispensing as needed, the labels for all medications shall bear at least: (a) The resident’s full name; (b) The name of the drug; (c) Strength; (d) Original filling date and date refilled, if applicable; (e) Name of authorized prescriber; (f) Expiration date of medication (month, year); (g) Any special handling and storage instructions; (h) Name and address of dispensing pharmacy; (i) Prescription number; (j) Number of tablets or capsules; and (k) Accessory federal labels. (2) A nurse may not package, repackage, bottle, or label any medication, in whole or in part, or alter any labeled medication in any way. E. Storage. (1) The nursing home shall store medications in a locked medication storage area that: (a) Is well lighted; (b) Is located where personnel preparing drugs for administration will not be interrupted; (c) Is spacious enough to allow separate storage of external and internal medications; (d) Is kept in a clean, orderly and uncluttered manner; and (e) Contains a refrigerator to be used for medication storage only. (2) The nursing home shall keep poisons and medications marked “for external use only” separate from general medications and Schedule II drugs. F. Schedule II—IV Drugs. (1) Schedule II drugs shall be kept in separately locked, securely fixed boxes or drawers in the storage area, under two locks. The lock on the door of a medication room shall be counted as one of the two locks. (2) A nurse and a second staff member who is a nurse or an administrator may destroy controlled dangerous substances in Schedules II—V on the premises of the nursing home. (3) If a controlled dangerous substance is destroyed on the nursing home premises in accordance with §F(2) of this regulation: (a) A record of the disposal, in addition to any other required records, shall be maintained in the nursing home; and (b) A copy of the record of disposal shall be forwarded to the Office of Controlled Substances Administration. (4) A nursing home, whether or not operating a licensed pharmacy, shall maintain a signed record of a Schedule II count at each change of shift. (5) A nursing home that administers Schedule II drugs shall maintain a drug record that documents: (a) The name of the resident; (b) The date, time, kind, dosage, and method of administration of all Schedule II drugs; and (c) The name of the authorized prescriber who prescribed the medication. #### Regulation .27 Pharmaceutical Management. *COMAR 10.07.02.27* A. Administration Procedures. (1) Medications, legend and non-legend, administered to residents shall be ordered in writing by the resident’s physician. (2) Medications shall be administered by: (a) Appropriately licensed personnel in accordance with laws and regulations governing these acts; or (b) Certified graduates of a State-approved medicine aide course. (3) The individual who prepares medications shall give and record them. (4) Medicine may not be returned to the container. If the resident refuses the drug or if a mistake occurs: (a) The drug shall be discarded; and (b) The occurrence shall be documented in the resident’s chart. (5) Before invoking stop order policies, the resident’s attending physician shall be contacted for instructions so that continuity of the resident’s therapeutic regimen is not interrupted. If the attending physician cannot be reached, the medical director shall be contacted for instructions. B. Pharmaceutical Services. (1) The nursing home shall arrange for pharmacies that provide medications for residents in the nursing home. The pharmacy shall agree in writing to maintain at the pharmacy a resident profile record system for each resident in the nursing home for whom prescriptions are dispensed. (2) If the nursing home does not employ a licensed pharmacist, the nursing home shall arrange by written contract for a pharmacy to provide consultation on administering the pharmacy services in accordance with the policies and procedures established by the pharmaceutical services committee. Pharmaceutical services shall be under the general supervision of a licensed pharmacist who shall: (a) With the advice of the pharmaceutical services committee, be responsible for developing, coordinating, and supervising pharmaceutical services and provide in-service training at least twice yearly; (b) Visit the nursing home frequently enough to ensure that policies and procedures established by the pharmaceutical services committee are enforced; (c) Notify the attending physician of any potential drug problems found during the drug regimen review; and (d) At least quarterly, submit a report to the pharmaceutical services committee on the status of the nursing home’s pharmaceutical services and staff adherence to policies and procedures. C. Resident-Designated Pharmacy. (1) The nursing home shall inform a resident’s designated pharmacy about the nursing home’s written policies concerning the provision of drugs. (2) To provide services to the resident, a designated pharmacy shall agree to comply with the nursing home’s policies. (3) If the pharmacy fails to comply with the policies, a representative of the nursing home shall discuss the situation with the pharmacy and the resident, and if the pharmacy subsequently refuses to follow the policies, the resident shall select another pharmacy that agrees to comply. (4) The pharmacy shall have access to a copy of the written pharmaceutical care policies. (5) The pharmacy shall be responsible for delivering medications to the nursing home. Members of the resident’s family or the responsible party for the resident may not deliver medications to the resident or to the nursing home. D. Medication Return and Disposal. (1) The nursing home shall return all prescribed medications, for residents who have been discharged or otherwise departed, to the pharmacy in accordance with the nursing home’s policy. (2) The nursing home shall destroy adulterated, deteriorated, or outdated medications in the following manner: (a) Disposal shall occur in the presence of two witnesses who are authorized by the nursing home; and (b) The witnesses shall document the disposal in the resident’s chart. (3) The nursing home shall only release prescribed medications to residents at the time of discharge based on the written authorization of the resident’s authorized prescriber. (4) Each month, the nursing home shall perform a drug regimen review on each resident’s records at the nursing home and document the findings in the resident’s medical record. E. Administration of Medications for Leave of Absence of 24 Hours or Less. (1) A nursing home shall develop policies and procedures to ensure that a resident or, if the resident lacks the capacity, the resident’s family or other individual accompanying the resident is informed, both orally and in writing, on how the resident shall safely and correctly take the resident’s medications during a short-term leave of absence of 24 hours or less. (2) In accordance with a nursing home-developed procedure, a licensed nurse shall prepare medications to be sent with a resident during a short-term leave of absence of 24 hours or less. #### Regulation .28 Laboratory and Radiologic Services. *COMAR 10.07.02.28* A. Approved Source. Laboratory services provided by the facility shall meet the applicable conditions established under COMAR 10.10.01 Medical Laboratories in Maryland. B. Provisions of Services. If the facility does not provide laboratory and radiologic services, arrangements shall be made for obtaining these services from a physician's office, a licensed laboratory in a hospital or nursing facility, a licensed independent laboratory, or a State-approved portable X-ray supplier. C. Physician's Order Required. All services shall be provided only on the orders of the attending physician. D. Reports of Findings. The nursing home shall notify the attending physician promptly of the findings. The nursing home shall file signed and dated reports of diagnostic services in the resident’s medical record. E. Transportation. The nursing home shall assist the resident, if necessary, in arranging transportation to and from the source of service. F. Blood and Blood Products — Blood Handling and Storage. Blood handling and storage facilities shall be safe, adequate, and properly supervised. G. Storage and Transfusion. If the facility provides for maintaining and transfusing blood and blood products, it shall meet the standards in COMAR 10.10.02 Blood Banks. H. Transfusion Services. If the nursing home only provides transfusion services, it shall meet at least the requirements established under COMAR 10.10.02. #### Regulation .29 Dental Services. *COMAR 10.07.02.29* A. Provision for Dental Care. Residents shall be assisted to obtain routine and emergency dental care. B. Advisory Dentist. There shall be an advisory dentist who shall: (1) Recommend oral hygiene policies and practices for the care of the residents and for arrangements for emergency treatment; (2) Assist in the formulation of dental health policies; (3) Provide direction for in-service training to give the nursing staff an understanding of residents’ dental problems. C. Assistance by Nursing Personnel. Nursing personnel shall assist the resident in carrying out routine dental hygiene. D. Arrangements for Dental Service. If dental services are not provided on the premises, there shall be a cooperative agreement with a dental service. E. Transportation. Arrangements shall be made, when necessary, for the resident to be transported to the dentist’s office. #### Regulation .30 Social Work Services. *COMAR 10.07.02.30* A. Services Provided. The nursing home shall provide or make arrangements for services to identify and meet the resident’s medically related physical, social, and behavioral health needs. B. Social Work Staff Responsibility. (1) Social services responsibilities in the nursing home shall be assigned to a: (a) Licensed bachelor social worker; (b) Licensed graduate social worker; (c) Licensed certified social worker; or (d) Licensed certified social worker–clinical. (2) If the social worker is not a licensed certified social worker (LCSW) or a licensed certified social worker-clinical (LCSW-C), the nursing home shall arrange for an LCSW or LCSW-C to provide sufficient hours of supervision. (3) As of January 1, 2021, a license is required for an employee to provide social services except if: (a) On the effective date of these regulations, the employee was assigned responsibility for social services; and (b) The nursing home has an agreement with a qualified social work consultant that provides for sufficient hours of supervision to assure that the employee’s services meet the medically related physical, social, and behavioral health needs of the residents. C. Social History. Within 7 days after admission, the social worker shall initiate a written social history, which shall be as complete as possible and shall include: (1) Social data about personal and family background to provide understanding of the resident and how the resident functions; (2) Information regarding current personal and family circumstances and attitudes as they relate to the resident’s illness and care; and (3) Information regarding the resident’s and family’s plans regarding discharge. D. Records. Records shall include the information required in §C of this regulation. E. Space. A nursing home shall provide: (1) Space for social work personnel, accessible to residents, medical, and other staff; and (2) Privacy for interviews. #### Regulation .31 Resident Activities. *COMAR 10.07.02.31* A. Activities Program. The nursing home shall provide: (1) A program of structured and unstructured activities; and (2) Activities designed and monitored appropriately to meet the day-to-day needs and interests of each resident and encourage: (a) Self-care; (b) Engagement in resident-selected activities; and (c) Maintenance of an optimal level of psychosocial functioning. B. Staffing. A staff member who is qualified by experience or training shall be appointed to be responsible for the activities program. If the designee is not a qualified resident activities coordinator as defined in Regulation .01 of this chapter, the Department may approve the designee based on the person’s education, performance, and experience. C. If the Department determines that an effective program is not maintained consultation may be required as specified by the Department. D. Restrictions on Participation Documented on Chart. The physician shall document in the resident’s chart any restrictions applicable to the resident’s participation in the activities program. E. Objective. The activities shall be designed to promote the general health and physical, social, and mental well-being of the residents. F. Space, Supplies. The nursing home shall provide adequate space and a variety of supplies and equipment to satisfy the appropriate individual activity needs of residents. #### Regulation .32 Clinical Records. *COMAR 10.07.02.32* A. Records for all Residents. Records for all residents shall be maintained in accordance with accepted professional standards and practices. B. Contents of Record. Contents of record shall include: (1) Identification and summary sheet or sheets including: (a) Resident’s name; (b) Social Security number; (c) Armed forces status; (d) Citizenship; (e) Marital status; (f) Age; (g) Sex; (h) Home address; and (i) Religion; (2) Names, addresses, and telephone numbers of referral agencies, including: (a) Hospital from which admitted; (b) Personal physician; (c) Dentist; (d) Parents’ names or next of kin; and (e) Resident’s representative; (3) Documentation of the: (a) Needs of the resident; (b) Establishment of an appropriate initial and ongoing treatment plan; and (c) Care and services provided; (4) Authentication of hospital diagnoses, based on a: (a) Discharge summary; (b) Report from the resident’s attending physician; or (c) Transfer form; (5) Consent forms when required, such as: (a) Administration of investigational drugs; (b) Burial arrangements made in advance; (c) Release of medical record information; and (d) Handling of finances; (6) Medical and social history of the resident; (7) Report of physical examination; (8) Diagnostic and therapeutic orders; (9) Consultation reports; (10) Observations and progress notes; (11) Reports of medication administration, treatments, and clinical findings; (12) Discharge summary including final diagnosis and prognosis; (13) Assessments done by various disciplines; and (14) Interdisciplinary care plan. C. Staffing. An employee of the nursing home shall be designated as the person responsible for the overall supervision of the medical records service. There shall be sufficient support staff to accomplish all medical records functions. D. Consultation. If the medical records supervisor is not a qualified medical record practitioner, the Department may require that the supervisor receive consultation from a qualified person. E. Completion of Records and Centralization of Reports. (1) Current medical records and those of discharged residents shall be completed promptly. (2) All clinical information pertaining to a resident’s stay shall be centralized in the resident’s medical record. F. Retention and Preservation of Records. (1) Medical records shall be retained for a period of at least 5 years from the date of discharge or, in the case of a minor, 3 years after the resident becomes of age or 5 years, whichever is longer. (2) The nursing home shall maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitles 3 and 4, Annotated Code of Maryland. G. Current Records — Location and Facilities. The nursing home shall maintain adequate space and equipment, conveniently located, to provide for efficient processing, reviewing, indexing, filing, and prompt retrieval of medical records. H. Closed or Inactive Records. Closed or inactive records shall be filed and stored in a safe place, free from fire hazards, which provides for confidentiality and, when necessary, retrieval. I. Electronic Health Records. (1) A nursing home that uses electronic health records exclusively or along with a paper-based medical record shall comply with this chapter and all applicable State and federal laws, including laws governing privacy and security of records. (2) Staff and nursing home-approved practitioners shall be trained in the use of electronic health records. (3) A nursing home that uses electronic health records shall: (a) Ensure access to residents as specified in COMAR 10.07.09.08C(13) and (14); and (b) On request, provide the resident with copies of the resident’s medical records at a reasonable cost and in the resident’s preferred format. (4) A nursing home shall provide full access to electronic health records in accordance with all applicable laws and regulations to: (a) Representatives of the Department as set forth in COMAR 10.07.02.07; (b) An ombudsman as set forth in Human Services Article, §10-905, Annotated Code of Maryland; and (c) Other legal representatives as set forth in COMAR 10.07.09.08 and authorized by law to obtain access. (5) A nursing home shall develop a system to ensure that nursing home staff have access to residents’ health records in the event of a failure of the nursing home’s electronic medical record system. #### Regulation .33 Infection Prevention and Control Program. *COMAR 10.07.02.33* A. Infection Prevention and Control Program. The nursing home shall establish, implement, and maintain an effective infection prevention and control program that: (1) Investigates, controls, and prevents infections in a timely manner through a system that enables the facility to: (a) Analyze patterns of infected individuals; (b) Analyze changes in prevalent organisms; (c) Analyze increases in the rate of infection; and (d) Obtain surveillance data for the prevention and control of additional cases; (2) Determines the procedures, such as appropriate precautions, that are to be applied to an individual resident; (3) Maintains a record of infections in the nursing home and the corrective actions that were taken related to infections; and (4) Monitors and evaluates the: (a) Effectiveness of the infection prevention and control program by surveying rates of infection, especially infection rates that are significantly higher than usual; and (b) Effective implementation of the policies and procedures that are outlined in §E(1) of this regulation. B. Infection Preventionist. (1) The nursing home shall assign at least one infection preventionist that has attended training in infection surveillance, prevention, and control to actively manage the nursing home’s infection prevention and control program. (2) The infection preventionist shall attend or have attended a basic infection prevention and control training course that is approved by the: (a) Office of Health Care Quality; and (b) Office of Infectious Disease Epidemiology and Outbreak Response for the Department. (3) This position shall be staffed at a ratio of 1.0 Full Time Equivalents for every 200 beds. C. The nursing home shall have mechanisms for communicating the results of infection control activities to employees and to the individual or individuals who are responsible for improving the nursing home’s performance. D. The nursing home’s communication mechanism shall ensure that the administrator, director of nursing, and the medical director receive and address reports of infection prevention and control findings and recommendations in a timely manner. E. Infection Prevention and Control Policies and Procedures. (1) The infection prevention and control program shall establish written policies and procedures to identify, investigate, control, and prevent infections in the nursing home, including policies and procedures to: (a) Identify health care-associated infections and communicable diseases in accordance with COMAR 10.06.01; (b) Report occurrences of certain infectious diseases and outbreaks of infectious diseases to the local health department in a timely manner in accordance with COMAR 10.06.01 and Health-General Article, §18-202, Annotated Code of Maryland; (c) Institute appropriate control measures when an infection or outbreak of infections is suspected or identified in order to control infection and prevent spread to other residents; (d) Perform surveillance for health care-associated and community-associated infections of residents and employees using definitions and methods approved by the infection prevention and control oversight committee to monitor and investigate causes of infection, and the manner in which the infection is spread; (e) Train employees about infection prevention and control, including: (i) Standard precautions and hand hygiene; (ii) Respiratory hygiene and cough etiquette; (iii) Soiled laundry and linen processing; (iv) Safe handling of needles and sharps and safe injection techniques; (v) Special medical waste handling and disposal; (vi) Appropriate use of antiseptics and disinfectants; (vii) Blood-borne pathogens, including hepatitis B and C and human immunodeficiency virus; (viii) Tuberculosis exposure; and (ix) Proper use and wearing of personal protective equipment, such as gloves, gowns, and eye protection; (f) Train and perform compliance monitoring of employee application of infection prevention and control activities, such as hand hygiene and personal protective equipment used for isolation precautions; (g) Review the infection prevention and control program elements at least annually and revise as necessary; and (h) Obtain annual approval of infection prevention and control program activities by the infection prevention and control oversight committee. (2) The nursing home shall provide information concerning the infectious disease status of any resident being transferred or discharged to any other nursing home, including a funeral home. (3) The nursing home shall obtain information concerning the infectious disease status of any resident being transferred or admitted to the nursing home from elsewhere. F. Preventing Spread of Infection. (1) The facility shall assess any residents with signs and symptoms of an infectious illness for the possibility of transmission to another resident or employee. (2) The nursing home shall take appropriate infection prevention and control measures to prevent the transmission of an infectious disease to residents, employees, and visitors as outlined in the following guidelines: (a) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; and (b) Guideline for Infection Control in Health Care Personnel. (3) The nursing home shall prohibit employees with an infectious disease or with infected skin lesions from having direct contact with residents or their food if direct contact could transmit the disease. (4) The nursing home shall require employees to perform hand hygiene before and after each direct resident contact for which hand hygiene is indicated by accepted professional practice. (5) The facility shall handle, store, process, and transport linens so as to prevent the spread of infection. #### Regulation .34 Employee Health Program. *COMAR 10.07.02.34* A. The nursing home’s infection prevention and control program shall monitor the relevant health status of all employees, as it relates to infection prevention and control. The nursing home shall refer to the following guidelines in implementing its employee health program: (1) Guideline for Infection Control in Health Care Personnel; (2) Immunization of Health Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC); and (3) COMAR 09.12.31. B. Tuberculosis Exposure Control. (1) The infection control program shall include a risk assessment program, including monitoring for tuberculosis infection for employees that is in accordance with the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. (2) The nursing home shall ensure that employees may not provide services that require direct access to residents without documented evidence that the employee is free from communicable tuberculosis. (3) A new employee shall be assessed for risk of tuberculosis through: (a) A two-step tuberculin skin testing at the time of hire following guidelines referenced in the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings; or (b) An interferon-gamma release assay (IGRA) blood test. (4) The nursing home shall maintain written documentation of the following: (a) Results of tuberculin skin tests, recorded in millimeters of induration with dates of administration, dates of reading, results of test, and the manufacturer and lot number of the purified protein derivative (PPD) solution used; and (b) Any previous tuberculin skin tests, chest x-ray, or blood test results, chemotherapy, and chemoprophylaxis that are the basis for certifying that the individual is free from tuberculosis in a communicable form. C. Measles, Mumps, Rubella, and Varicella. (1) The nursing home shall screen and maintain written documentation of each employee’s proof of immunity to common childhood infections including measles, mumps, rubella, and chickenpox (varicella). Proof of immunity to these diseases shall be verified by: (a) Documented evidence of administration of vaccine; or (b) Laboratory evidence of immunity. (2) The nursing home shall require that employees who are not immune to measles, mumps, rubella, and varicella receive immunization for measles, mumps, rubella, or varicella, unless medically contraindicated or against the employee’s religious beliefs. If the employee refuses to be immunized, the nursing home shall document the refusal and the reason for it. D. Hepatitis B. The nursing home shall require that all new employees receive immunization for Hepatitis B, unless medically contraindicated, against the employee’s religious beliefs, or after being fully informed of the health risks of not being immunized. The nursing home shall inform all new and current employees of the health risks of not being immunized. If the employee refuses to be immunized, the nursing home shall document the refusal and the reason for the refusal. E. Influenza. (1) The nursing home shall require that all employees receive annual immunization for influenza, unless: (a) Medically contraindicated; (b) Against the employee’s religious beliefs; or (c) After being fully informed of the health risks associated with not receiving a vaccine, the employee refuses the immunization. (2) The nursing home shall: (a) Comply with Health-General Article, §18-404, Annotated Code of Maryland, regarding immunizations of employees; (b) Inform all new and current employees of the health risks of not being immunized; (c) Document refusals; and (d) Require that any employee who is not vaccinated with the current influenza vaccine wear a mask when: (i) Within 6 feet of a resident; and (ii) During the influenza season as specified by the State’s Prevention and Health Promotion Administration, based on influenza activity in Maryland. F. Pertussis. The nursing home shall: (1) Require that each new employee receive a one-dose booster immunization for pertussis, unless medically contraindicated or against the employee’s religious beliefs; (2) Inform all new and current employees of the health risks of not being immunized; (3) Document any refusals of immunization; and (4) Ensure that the immunization is given in the form of Tdap (tetanus, diphtheria, acellular pertussis) vaccine, in accordance with the guidelines prescribed in Immunization of Health-Care Personnel: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Health Care Infection Control Practices Advisory Committee (HICPAC). #### Regulation .35 Resident Health Program. *COMAR 10.07.02.35* A. Immunization. (1) The nursing home shall offer influenza and pneumococcal immunization to each resident. (2) The nursing home shall obtain written consent to administer the immunization from: (a) The resident; or (b) The resident's representative. (3) A resident is not required to receive the influenza and pneumococcal immunization if it is: (a) Medically contraindicated; (b) Against the resident’s religious beliefs; or (c) After being fully informed of the health risks associated with not receiving a vaccine, the resident refuses the immunization. (4) If the resident refuses to be immunized, the nursing home shall document the refusal and the reason for the refusal. (5) The nursing home shall notify each prospective resident of the immunization requirements and request that the resident agree to be immunized. (6) The nursing home shall make available to residents educational and informational materials relating to immunization against influenza virus and immunization against pneumococcal disease. B. Tuberculosis Assessment. (1) The nursing home shall assess residents for tuberculosis according to the Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health Care Settings. (2) A new resident shall receive a two-step tuberculin skin test within 10 days of admission to the nursing home unless the resident has had: (a) A documented negative tuberculin skin test within the previous 12 months; (b) A previous positive tuberculin skin test; (c) A history of preventive therapy treatment; (d) A latent infection; or (e) The treatment of active tuberculosis. (3) The nursing home shall continue to monitor residents for signs and symptoms of tuberculosis by performing a yearly symptom review. When a resident has signs and symptoms of tuberculosis, a physician shall be notified to: (a) Evaluate the resident for possible tuberculosis in a communicable form; (b) Notify the health officer within 24 hours if the physician suspects tuberculosis; and (c) Coordinate management of the resident and the resident’s contacts with the local health officer. (4) The nursing home shall assess and manage a resident with a history of a previous positive tuberculin skin test, a history of latent infection, or a previous history of active tuberculosis, in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings. #### Regulation .36 Volunteer Health Program. *COMAR 10.07.02.36* A. The nursing home shall urge that volunteers, defined as individuals who spend an average of 8 hours per week or more in the resident care areas and who receive no pay or benefits, receive annual influenza vaccination and tuberculin skin testing as considered necessary by the nursing home. B. The nursing home shall give appropriate health care information to such volunteers to provide maximum protection to residents. C. The nursing home shall maintain documentation of the discussion between the nursing home and the volunteer concerning influenza vaccine and tuberculin skin testing. #### Regulation .37 Infection Control — Standard Precautions. *COMAR 10.07.02.37* A. Standard Precautions. All employees shall routinely use appropriate barrier precautions to prevent skin and mucous membrane exposure when contact with blood or the body fluids of any resident is anticipated as outlined in: (1) 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings; and (2) COMAR 09.12.31. B. The infection prevention and control program shall include the handling of special medical waste as defined in COMAR 10.06.06. C. A nursing home shall maintain, at all times, the capability to physically isolate any resident who may contract a communicable disease from the remaining resident population. To provide for this, a nursing home shall have at least one private bedroom with an attached private bathroom that includes a: (1) Toilet; (2) Hand-washing sink; and (3) Bathtub, shower, or other bathing device. #### Regulation .38 Reports and Action Required in Unusual Circumstances. *COMAR 10.07.02.38* A. Serious Emotional Disturbances. A facility may not accept or keep patients who destroy property or are dangerous to themselves or others, or who have acute symptoms of mental illness. B. Action to Be Taken if a Patient Becomes Actively Disturbed. The following action shall be taken: (1) If a patient becomes actively disturbed, the personal physician shall be notified immediately. (2) A restraint may be used only if all of the following conditions are met: (a) Failure to use a restraint or restraints is likely to endanger the health or safety of the patient or others; (b) There is a written physician's order for the use of the restraint or restraints, which shall comply with the following requirements: (i) The physician's written order for the restraint or restraints shall be for a specified maximum period of time, not to exceed 24 hours. (ii) The necessity for the use of the restraint or restraints shall be documented, and (iii) The frequency of patient observations by licensed personnel on not less than an hourly basis during the period of time that the restraint or restraints or the effects of the restraint or restraints are present shall be indicated; (c) Appropriate documentation by licensed personnel shall be recorded in the clinical record; (d) The facility may not re-impose a restraint or restraints except upon the written order of a physician who has personally observed the patient since the previous restraint or restraints order was imposed. (3) A restraint or restraints may not be ordered PRN. (4) If a physician is not immediately available, a registered nurse may authorize the use of a physical restraint or restraints for a period not to exceed 4 hours in any 30-day period. Licensed personnel shall observe the patient hourly. The patient shall be seen by a physician if the restraint or restraints are to be applied for more than the initial 4-hour period. C. Unusual Occurrences. (1) The administrator of the nursing home shall immediately report to the local health department and the Department the occurrence of: (a) Infectious disease; (b) Poisoning; (c) Internal emergency or disaster; (d) External emergency or disaster, (e) Any symptomatic condition of importance to public health that affects the nursing home; or (f) Any other serious occurrence that threatens the welfare, safety, or health of any resident. (2) The administrator of the nursing home shall be responsible for ensuring that appropriate procedures and reporting are carried out for all reportable infections. An occurrence of a confirmed or suspected infection shall be reported and acted on in accordance with COMAR 10.06.01 and COMAR 10.15.03. #### Regulation .39 Transfer Agreement. *COMAR 10.07.02.39* A. Written Agreement. A written agreement with at least one acute hospital shall be effected which shall provide for the following actions: (1) Planning to ensure that all services required for the continuity of resident care will be made available promptly; (2) Advance discussion with the resident regarding the reason for the transfer and any available alternatives; (3) Notification to the next of kin or responsible person regarding the anticipated transfer; (4) Interchange of medical and other information necessary in the care and treatment of residents transferred between facilities, including notification of the licensed pharmacist of resident transfer; (5) Safe and timely transportation and care of the resident during transfer; (6) Security and accountability for the resident’s personal effects; (7) Prompt readmission to the nursing home at the end of the hospital stay; (8) Annual review of transfer arrangements by a utilization review committee or other designated group to ensure that each party is fulfilling the needs of the residents, the providers, the hospital, and the nursing home; (9) If needs are not being met, the administrator of the nursing home shall act on recommendations of the reviewing group to effect compliance; (10) Before licensure, the comprehensive care facility or the extended care facility shall submit to the Department a copy of the written agreement, signed by persons authorized to execute the agreement on behalf of the facilities; (11) Each facility shall maintain a signed copy of the agreement. B. Facilities Under Common Control. If two facilities are under common control, a written agreement is not required; policies and procedures of both facilities shall provide assurance that §A(1)—(12) will be the practice of the facilities. C. Human remains shall be transported pursuant to COMAR 10.29.21. #### Regulation .40 Emergency and Disaster Plan. *COMAR 10.07.02.40* A. Emergency and Disaster Plan. (1) The licensee shall develop an emergency and disaster plan that includes procedures that shall be followed before, during, and after an emergency or disaster, including: (a) Evacuation, transportation, or shelter in place of residents; (b) Notification of families and staff regarding the action that will be taken concerning the safety and well-being of the residents; (c) Staff coverage, organization, and assignment of responsibilities for ongoing shelter in place or evacuation, including identification of staff members available to report to work or remain for extended periods; and (d) The continuity of services, including: (i) Operations, planning, and financial and logistical arrangements; (ii) Procuring essential goods, equipment, and services to sustain operations for at least 72 hours; (iii) Relocation to alternate facilities or other locations; and (iv) Reasonable efforts to continue care. (2) The licensee shall have a tracking system to locate and identify residents in the event of displacement due to an emergency or disaster that includes at a minimum the: (a) Resident's name; (b) Time that the resident was sent to the initial alternative facility or location; and (c) Name of the initial alternative facility or location where the resident was sent. (3) When the nursing home relocates residents, the nursing home shall send a medical fact sheet and any medically related information with each resident that includes at a minimum the resident’s: (a) Name; (b) Medical condition or diagnosis; (c) Medications; (d) Allergies; (e) Special diets or dietary restrictions; (f) Family or legal representative contact information; and (g) Advance directives, living will, or a copy of the resident’s Maryland’s Medical Orders for Life-Sustaining Treatment (MOLST) form. (4) The brief medical fact sheet for each resident described in §A(3) of this regulation shall be: (a) Updated upon the occurrence of any change of information on the medical fact sheet; (b) Reviewed at least monthly; and (c) Maintained in a written, electronic, or printed form in a central location readily accessible and available to accompany residents in case of an emergency evacuation. (5) The licensee shall review the emergency and disaster plan at least annually and update the plan as necessary. (6) The licensee shall: (a) Identify a facility, facilities, alternate location, or alternate locations that have agreed to house the licensee's residents during an emergency evacuation; and (b) Document an agreement with each facility or location. (7) The licensee shall: (a) Identify a source or sources of transportation that have agreed to safely transport residents during an emergency evacuation; and (b) Document an agreement with each transportation source. (8) Upon request, a licensee shall provide a copy of the facility's emergency and disaster plan to the local emergency management organization for the purposes of coordinating local emergency planning. The licensee shall provide the emergency and disaster plan in a format that is mutually agreeable to the local emergency management organization. (9) The licensee shall identify an emergency and disaster planning liaison for the facility and shall provide the liaison's contact information to the local emergency management organization. (10) The licensee shall prepare an executive summary of its evacuation procedures to provide to a resident, family member, or legal representative upon request. The summary shall, at a minimum: (a) List means of potential transportation to be used in the event of evacuation; (b) List potential alternative facilities or locations to be used in the event of evacuation; (c) Describe means of communication with family members and legal representatives; (d) Describe the role and responsibilities of the resident, family member, or legal representative in the event of an emergency situation; and (e) Notify families that the information provided may change depending upon the nature or scope of the emergency or disaster. (11) Maryland Health Alert Network. (a) A nursing home shall register with the Maryland Health Alert Network. (b) A nursing home shall register at least four representatives, including the administrator and the director of nursing. (c) Following any changes in the initial registration of the four representatives, a nursing home shall update the information within 5 business days of the change. (12) The licensee shall: (a) Identify an emergency and disaster planning liaison for the nursing home; and (b) Provide the liaison’s contact information to the local emergency management organization. (13) The licensee shall prepare an executive summary of the nursing home’s evacuation procedures to provide to a resident, family member, or resident’s representative upon request. The summary shall, at a minimum: (a) List potential means of transportation to be used in the event of evacuation; (b) List potential alternative facilities or locations to be used in the event of evacuation; (c) Describe means of communication with family members and resident’s representatives; (d) Describe the role and responsibilities of the resident, family member, or resident’s representative in the event of an emergency situation; and (e) Notify families that the information provided may change depending on the nature or scope of the emergency or disaster. B. Evacuation Plans. The facility shall conspicuously post individual floor plans with designated evacuation routes on each floor. C. Orientation and Drills. (1) The licensee shall: (a) Orient staff to the emergency and disaster plan and to their individual responsibilities in relation to the plan within 24 hours of the commencement of job duties; (b) Document completion of the orientation in the staff member’s personnel file through the signature of the employee; and (c) Within 24 hours of admission, notify and direct residents to the nursing home’s emergency plans and maps, including evacuation procedures. (2) Fire Drills. (a) The licensee shall conduct fire drills at least quarterly on all shifts. (b) The licensee shall: (i) Document completion of each drill; (ii) Have all staff who participated in the drill sign the document; and (iii) Maintain the documentation on file for a minimum of 2 years. (3) Semiannual Emergency and Disaster Drill. (a) The licensee shall conduct a semiannual emergency and disaster drill on all shifts during which the facility practices evacuating residents or sheltering in place so that each is practiced at least one time a year. (b) The drills may be conducted via a table-top exercise if the licensee can demonstrate that moving residents will be harmful to the residents. (c) Documentation. The licensee shall: (i) Document completion of each drill or training session; (ii) Have all staff who participated in the drill or training sign the document; (iii) Document any opportunities for improvement as identified as a result of the drill; and (iv) Keep the documentation on file for a minimum of 2 years. (4) The licensee shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency. #### Regulation .41 Physical Plant — New and Existing Construction Requirements. *COMAR 10.07.02.41* A. Construction of a New Nursing Home. (1) A new nursing home shall be constructed, equipped, and maintained to protect the health and safety of residents, personnel, and the public. (2) A nursing home desiring to provide services other than those for which it is already licensed shall obtain prior approval from the Department. (3) The nursing home shall obtain prior approval from the Department for any part of the premises to be used for tenant occupancy or for unrelated business purposes. (4) A nursing home shall be constructed in accordance with the provisions of the NFPA 101 Life Safety Code. B. Construction in an Existing Structure. In existing structures, the Department shall entertain requests for waivers on items that: (1) Will not endanger the health and safety of residents, visitors, employees, and other individuals using the nursing home; and (2) If corrected, will result in an unreasonable, substantial financial burden on the nursing home. C. Conversion of an Existing Structure. When an owner plans to convert an existing structure that has not been licensed as a nursing or care home to a nursing home, the owner shall be required to meet all conditions set forth in this chapter. D. Preventative Maintenance Program. A nursing home shall have a documented preventative maintenance program. This program shall include: (1) Periodic service and testing of items as recommended by manufacturers of at least the following: (a) Building systems; (b) Building components; (c) Resident care equipment; (d) Resident therapy equipment; (e) Resident bathing and shower equipment; (f) Furniture and furnishings; (g) Wheelchairs; (h) Walkers; (i) Body lifts; (j) Scales; (k) Electronics; and (l) Electrical switches and outlets; (2) Ongoing staff monitoring for evidence of malfunction or deterioration; and (3) A centralized system for reporting and monitoring repairs. #### Regulation .42 Physical Plant — General Requirements. *COMAR 10.07.02.42* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. A nursing home shall comply with all applicable federal, State, and local governing laws, regulations, standards, ordinances, and codes. C. A nursing home shall be constructed to comply with the provisions of the NFPA 101 Life Safety Code, as promulgated by the State Fire Prevention Commission, that are applicable to nursing homes. D. Securely anchored handrails: (1) Shall be provided on each side of all corridors in resident areas; and (2) May not be more than 36 inches high as measured from the floor to the top of the handrail. E. Elevators. (1) New Construction. Elevators shall meet the requirements for elevators in a long-term care nursing home as set forth in the Guidelines for Design and Construction of Residential, Health, Care, and Support Facilities. (2) Existing Facilities. An existing nursing home shall meet all local codes and standards for safety and maintenance of institutional elevators. F. Lighting. (1) A resident’s room shall: (a) Be lighted by outside windows; and (b) Have artificial light adequate for reading and other uses as required. (2) In order to prevent accidents and promote efficiency of service, the nursing home shall ensure that the following areas have sufficient artificial lighting: (a) Entrances; (b) Hallways; (c) Stairways; (d) Inclines; (e) Ramps; (f) Basements; (g) Attics; (h) Storerooms; (i) Kitchens; (j) Laundries; and (k) Service units. G. Minimally Maintained Lighting Levels. The following table lists the minimum lighting requirements in the following given areas: H. Night Lights. (1) A nursing home shall have sufficient lighting at night in the following areas: (a) Hallways; (b) Stairs; and (c) Designated toilets of the nursing home for the safety of the resident who gets up during the night. (2) There shall be at least one night light in each bedroom for residents. (3) In new construction, the night light shall be located at the resident room door and be capable of being switched on and off. I. Screens. (1) A nursing home shall ensure that screened doors and windows are installed and maintained in accordance with applicable fire and safety codes and COMAR 10.15.03 Food Service Facilities. (2) Maintenance and installation may not conflict with other applicable laws, regulations, codes, or ordinances. (3) A nursing home shall equip all screened doors with self-closing devices, to provide for the normal flow of ingress and egress of traffic. (4) A nursing home shall screen with wire screen or its equivalent, not less than 16 meshes per linear inch for doors and windows that provide ventilation. J. Garbage Disposal. (1) Garbage shall be: (a) Stored in water-tight containers with tight-fitting covers; and (b) Emptied at frequent intervals. (2) Soiled containers shall be thoroughly scoured and aired before using again. K. Garbage Storage Space. Storage space shall be provided for garbage and trash awaiting pickup. L. Burning. A nursing home may not burn or incinerate garbage at the nursing home. M. Special Medical Wastes. The nursing home shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06. N. Smoking. (1) Resident Smoking Requirements. (a) A resident who smokes shall be assessed for safe smoking behaviors at admission and on significant changes in condition. (b) A resident assessed to exhibit unsafe behaviors shall have a care plan to ensure the resident is safe when smoking. (2) Nursing Home Smoking Requirements. (a) Smoking areas shall be designated. (b) Smoking shall be prohibited at the main entrance to all facilities. (c) All tobacco products shall be extinguished and disposed of in noncombustible containers with self-closing lids in accordance with the provisions of NFPA 101 Life Safety Code. O. A nursing home shall be protected throughout the entire building by an automatic fire extinguishing system. #### Regulation .43 Physical Plant — Plumbing. *COMAR 10.07.02.43* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Plumbing. (1) Plumbing shall be installed in conformance with all applicable federal, State, and local codes and ordinances. (2) Plumbing and water supplies shall be protected against backflow within a nursing home. (3) Prevention of backflow shall be ensured by proper installation of: (a) Plumbing cross-connections; (b) Submerged inlets; and (c) Back siphonage. C. Sewage. The nursing home shall be serviced by a public sewage disposal system if available. D. Private Sewage Disposal Approval. (1) If no approved public sewerage system is available, a private sewage disposal may be used, if it is approved by the Department. (2) Private sewage disposal systems shall comply with COMAR 26.04.02. E. Water Supply. A nursing home shall be served by water from a safe public water supply, if available, as determined by the Department. F. Approval of Private Water Supply. (1) If a safe public water supply is not available, a private water supply may be used if it is approved by the Department. (2) Private water systems shall comply with all federal, State, and local requirements. G. Emergency Procedures. Emergency procedures shall be established and documented that enable the nursing home to provide water in all essential areas in the event of the loss of the normal water supply or if the nursing home would have to shelter in place during an emergency or disaster. These written procedures shall: (1) Be a part of the nursing home’s Emergency and Disaster Plan, in conformance with Regulation .40 of this chapter; and (2) Describe the nursing home’s plan to ensure that there is an adequate amount of safe drinking water for all residents and staff for a minimum of 72 hours. H. Adequacy of Pressure. (1) The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve equipment in the nursing home. (2) A minimum pressure of 15 psi during demand period is required at top floor equipment. I. Temperature. The water heating equipment shall supply adequate amounts of heated water according to the following temperature guidelines for: (1) Resident use, the water temperature shall be between 100°F (38°C) and 120°F (49°C): (a) Washing; (b) Bathing; and (c) Other personal use; (2) Food preparation use, as referenced in COMAR 10.15.03; and (3) Laundry use, as referenced in the 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. #### Regulation .44 Physical Plant — Heating and Cooling. *COMAR 10.07.02.44* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Temperatures. A nursing home shall maintain a minimum design temperature of 75°F or 24°C for all occupied areas. C. Heating System. A nursing home shall be equipped with a properly maintained and operational central heating system. The heating system shall be: (1) Capable of maintaining 75°F or 24°C throughout the residents’ section of the building with the outside temperature as prescribed in the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities; and (2) In compliance with NFPA 101 Life Safety Code, NFPA 99 Health Care Facilities Code, and other applicable codes, and all federal, State, and local codes. D. Humidity. The humidity shall be controlled according to the guidelines prescribed in the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. E. Auxiliary Heat. Appropriate provisions shall be made for emergency auxiliary heat by means of alternative sources of electric power, alternative fuels, or standby equipment. F. Space Heaters. Space heaters and portable heaters may not be used. G. Boiler rooms. Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and to limit temperatures in working stations to 97°F or 36°C. H. Air Conditioning. (1) A nursing home shall be equipped with a properly maintained air conditioning system. (2) The air conditioning system shall be in compliance with NFPA 101 Life Safety Code, NFPA 99 Health Care Facilities Code, and all federal, State, and local codes. (3) In an existing structure, the nursing home shall comply with the regulations and building codes effective at the date of construction. (4) In new construction or renovation, the nursing home shall comply with the regulations and building codes effective at the date of construction or renovation. #### Regulation .45 Physical Plant — Ventilation. *COMAR 10.07.02.45* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. An existing nursing home shall provide for adequate ventilation through windows or mechanical means or a combination of both. C. A new nursing home shall adhere to the requirements of this chapter. D. Ventilation System Details. (1) All air-supply and air-exhaust systems shall be mechanically operated. (2) The ventilation rates shown in Table 1 under §D(10) of this regulation shall be considered the minimum acceptable rates and may not be construed as precluding the use of higher ventilation rates. (3) All fans serving exhaust systems shall be located at the discharge end of the system. (4) Outdoor air intakes shall be located: (a) As far as practical but not less than 25 feet from: (i) Exhaust outlets of ventilating systems; (ii) Combustion equipment stacks; (iii) Medical-surgical vacuum systems; (iv) Plumbing vent stacks; or (v) Areas that may collect vehicular exhaust and other noxious fumes; and (b) As high as practical, so that the bottom of the outdoor air intake is: (i) At least 6 feet above ground level; or (ii) At least 3 feet above roof level. (5) The ventilation systems shall be designed and balanced to provide the pressure relationships as shown in Table 1 under §D(10) of this regulation. (6) The bottoms of ventilation openings may not be not less than 3 inches above the floor of any room. (7) Corridors may not be used to supply air to or exhaust air from any room, except that air from corridors may be used to ventilate bathrooms, toilet rooms, janitors’ closets, and small electrical or telephone closets opening directly on corridors. (8) Filters. (a) A central ventilation or air conditioning system shall be equipped with filters having efficiencies no less than those specified in Table 2 under §D(11) of this regulation. (b) The filter bed shall be located upstream of the air conditioning equipment, unless a prefilter is employed. (c) If a prefilter is employed, the prefilter shall be upstream of the equipment and the main filter bed may be located further downstream. (d) A filter or filter efficiency shall comply with the standards of the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. (e) A filter frame shall be durable and carefully dimensioned and shall have an airtight fit with the enclosing duct work. (f) A joint between filter segments and the enclosing duct work shall be gasketed or sealed to provide a positive seal against air leakage. (g) A manometer shall be installed across each filter bed serving central air systems. (9) Air Ducts. (a) Air-handling duct systems shall meet the requirements applicable to nursing homes cited in NFPA 99 Health Care Facilities Code. (b) Fire and smoke dampers shall be constructed, located, and installed in accordance with the requirements of NFPA 101 Life Safety Code. (c) Air ducts that pass through a required smoke barrier shall be provided with a smoke damper at the barrier. (d) Smoke dampers shall activate by smoke detectors located in the ducts at the smoke barrier, or by the smoke detectors used to close smoke barrier doors. (e) Smoke dampers shall be controlled to close automatically to prevent flow of smoke-laden air in either direction. (f) Smoke dampers shall be equipped with automatic remote control reset devices, except that manual reopening will be permitted if smoke dampers are accessible. (g) All devices shall be interlocked with the fire alarm system. (10) Table 1. This table refers to the pressure relationships and ventilation of certain areas of a nursing home other than chronic disease hospitals. (11) Table 2. This table refers to the filter efficiencies for central ventilation and air conditioning systems in a nursing home other than chronic disease hospitals. (12) Exhaust Hoods. All hoods over cooking surfaces shall comply with the requirements as provided in COMAR 10.15.03. #### Regulation .46 Physical Plant — Emergency Power. *COMAR 10.07.02.46* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Emergency Electrical Power. (1) The nursing home shall provide emergency electrical power. (2) Emergency power for the purpose of egress lighting and protection shall be as required by NFPA 101 Life Safety Code. (3) Other emergency lighting shall be as follows: (a) Nursing station; (b) Drug distribution station or unit dose storage; (c) A lighted area for emergency telephone use; (d) Boiler or mechanical room; (e) Kitchen; (f) Generator set location and switch gear location; (g) Elevator, if operable on emergency power; (h) Areas where life support equipment is used; (i) If applicable, lighting for the common area of refuge; and (j) If applicable, lighting in toilet rooms of the common area of refuge. (4) Emergency power shall be provided for the: (a) Nurses’ call system; (b) Duplex receptacles installed 50 feet apart in all corridors in resident areas or appropriately located duplex receptacles in the common area of refuge; (c) Telephone service with at least one telephone available for incoming and outgoing calls; (d) Fire pump; (e) Sewerage pump and sump pump; (f) Elevator, if required, for evacuation as referenced in NFPA 101 Life Safety Code; (g) Heating equipment, if applicable, to maintain a minimum temperature of 71°F or 22°C in the common areas of refuge; (h) Life support equipment; (i) Nonflammable medical gas systems; (j) Computer system, if applicable, to enable use of electronic medical records system; and (k) Refrigerated medication storage. (5) Common Area or Areas of Refuge. (a) The nursing home shall provide a common area or areas of refuge in an emergency situation if all resident rooms, day rooms, and toilet rooms are not tied into the emergency generator to provide heat and cooling. (b) The common area or areas of refuge: (i) Shall be at least 30 square feet per bed, not including corridors; (ii) May not include toilet rooms in the 30 square feet per bed; and (iii) Shall maintain a minimum temperature of 71°F or 22°C and a maximum temperature of 81°F or 27°C. (c) The nursing home shall provide heated toilet rooms adjacent to the common areas of refuge. (d) The nursing home shall provide a Department-approved written plan that: (i) Defines the specified area of refuge; (ii) Outlines paths of egress from the common areas of refuge; and (iii) Describes provisions for light, heat, food service, washing, and toileting residents. (6) Emergency Power Source. (a) The emergency power source shall be a generating set and prime mover located on the premises with automatic transfer. (b) The emergency generator shall: (i) In the event of failure of the normal electrical service, be activated immediately; (ii) Come to full speed and load acceptance within 10 seconds; (iii) Have a capacity of 48 hours of operation from fuel stored on-site; and (iv) Be tested once a month, for at least 30 minutes under normal emergency nursing home connected load, and the test recorded in a permanent log book maintained for that purpose. #### Regulation .47 Nursing Care Unit. *COMAR 10.07.02.47* A. Size. Nursing care units may not exceed 60 beds. The Department may specify the numbers and types of personnel for each unit which exceeds 40 beds. B. Common Space. The nursing home shall provide a living room for residents’ use with a sufficient number of reading lamps, tables, and comfortable chairs or sofas. C. Service Areas Required. (1) Nurses’ Work Area. (a) The nurses’ work area shall be located on the unit and within easy view of corridors outside of residents’ rooms. (b) The Department may specify the location and size of a nurses’ work area which serves a nursing care unit exceeding 40 beds. (2) Nursing Care Unit. (a) A nursing care unit, regardless of size, including special care units, shall be equipped as described in this regulation. (b) A nursing care unit bathroom shall include: (i) A toilet, within the care unit, for the use of personnel; and (ii) A hand-washing sink equipped with goose-neck spout, separate soap dispenser, and disposable paper towel dispenser. (c) A nursing care unit’s medicine shall be stored in accordance with the following procedures: (i) Shall be stored in a cabinet with locks; (ii) Schedule II drugs shall be kept in a separately locked, securely fixed box or drawer in the medicine storage cabinet under two locks, keyed differently; (iii) The medicine storage and preparation area shall be illuminated with at least 100 foot-candles at the work counter; (iv) The preparation area shall include a small sink set into the counter or with drain boards and a biological refrigerator; and (v) The medicine storage cabinet, medicine preparation area, and biological refrigerator shall be under the direct visual control of the nursing or pharmacy staff. (d) Nurses' call system. (e) Charting desk and supplies. (f) Storage space for miscellaneous medical supplies which shall be protected from contamination. (g) A nursing care unit shall have sufficient space and equipment for medical records so that personnel can function effectively and maintain easily accessible records for all residents. (3) Medication Storage in Nursing Home. (a) The storage facility shall provide for the conditions listed in §C(3)(b)—(g) of this regulation when prescribed. (b) Cold — Any temperature at or below 46°F or 8°C. A refrigerator is a cold place in which the temperature is maintained thermostatically between 46°F and 59°F or 8°C and 15°C. A freezer is a cold place in which the temperature is maintained thermostatically between -4°F and -14°F or -20°C and -26°C. (c) Cool — Any temperature between 46°F and 59°F or 8°C and 15°. An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator, unless otherwise specified in the individual monograph. (d) Room Temperature — The temperature prevailing in a working area. Controlled room temperature is a temperature maintained thermostatically between 59°F and 86° F or 15°C and 30°C. (e) Warm — Any temperature between 86°F and 104°F or 30°C and 40°C. (f) Excessive Heat — Any temperature above 104°F or 40°C. (g) Protection from Freezing. The container label bears appropriate instructions to protect the product from freezing when freezing it may subject a product to: (i) Loss of strength or potency; (ii) Risk of breakage of the container; or (iii) Destructive alteration of the dosage form. (h) Storage under Non-specific Conditions. When no specific storage directions or limitations are provided in the individual monograph, the storage conditions shall include protection from moisture, freezing, and excessive heat. (4) Space for Storage of Linen. Capacity shall be provided for storing of at least two complete linen changes per bed. Clean linen shall be stored separately from unclean items. (5) Janitor Closet — New Construction. (a) A nursing unit shall contain at least one janitor closet containing a floor receptor or service sink and storage space for housekeeping equipment and supplies. (b) The janitor closet shall be equipped for hand washing. (c) The janitor closet shall be connected to mechanically operated exhaust ventilation. (d) The plumbing fixture for the utility or service sink within a janitor closet shall be provided with a back-flow prevention device. (6) Utility Rooms. (a) There shall be separate clean and soiled utility rooms in each nursing unit: (i) Accessible to the resident area; (ii) Each having separate entrances; and (iii) No more than 120 feet to the most remote resident bedroom. (b) The clean utility room shall contain: (i) A small sink equipped with gooseneck spout and wrist blades; (ii) Soap and individual paper towels in a dispenser; (iii) Adequate storage and work counter space for storage and assembly of supplies for nursing procedures; and (iv) Clean linen stored and transported in covered containers, closed linen carts, or rooms exclusively provided for this purpose. (c) The soiled utility room shall contain: (i) Work counter with sink, gooseneck faucet, and wrist blades; (ii) A small sink equipped with soap and individual paper towels in a dispenser; (iii) Space for waste receptacles and soiled linen receptacles; provision for storing and transporting soiled linen in covered leakproof containers; (iv) Equipment to clean and sanitize bedpans, urinals, and basins; and (v) Equipment for the disposal of liquid and semi-solid wastes and bodily fluids via the nursing home’s sanitary sewer connection or on-site sewage disposal system. (7) Culture Change Nursing Home. In a culture change nursing home, service areas shall be provided for resident care needs as approved by the Department. The culture change nursing home shall be required to have service areas that meet the specifications in this chapter for: (a) Clean storage; (b) Soiled holding; (c) Laundry; (d) Janitorial services; and (e) Medication storage. D. Drinking Fountains. One public drinking fountain or comparable equipment as preapproved by the Department shall be provided on each floor, usable from a wheelchair. Alternative means to provide drinking water to residents, staff, and the general public may be used as approved by the Department. E. Automated External Defibrillator. (1) A nursing home shall possess a functioning automated external defibrillator (AED). (2) As of July 1, 2020, a nursing home shall install a functioning AED unit. #### Regulation .48 Call Systems. *COMAR 10.07.02.48* A. Call System. (1) A nurse call system shall be installed and maintained in operating order in all nursing units. (2) A call system shall be maintained in a manner that will provide visible and audible signal communication between nursing service personnel and residents. (3) A call station shall provide readily accessible and detachable extension cords to each resident’s bed in the residents’ rooms at all times. (4) A call system shall have a visible signal above the door of each resident’s bedroom that shall be visible from all parts of the corridor. (5) A call system shall provide visual lights at corridor intersections, in multi-corridor nursing units. (6) A call system shall be provided in each resident’s bathroom and bathing area in locations accessible to the residents. (7) The call system shall enable residents in the rehabilitation area to summon rehabilitation staff. (8) The nurses’ call system shall require resetting at the station where the call originates. B. Wireless Call Systems. (1) A call system that uses wireless pagers or other wireless communication devices may be used as an alternative system. (2) A wireless device shall: (a) Be issued to all assigned direct care staff; and (b) Receive signals originating from residents’ bedrooms, bathrooms, bathing areas, and therapy areas. (3) The use of an approved wireless call system shall eliminate the need to install call light indicators outside the residents’ bedrooms, bathrooms, bathing areas, and therapy areas. (4) A computer system with a monitor or other electronic display device may be installed to replace the call system annunciator, as long as it reveals the location where the signal originated and sounds an audible alert tone. Otherwise, a dedicated annunciator connected to the wireless call system will be needed. (5) An electrically powered call system shall be connected to the emergency power supply. (6) The sounding of the audible signal shall be continuous or intermittent until answered. (7) The audible signal may not be turned off at the nursing station. (8) The audible signal shall be loud enough to be heard at the nurses’ station. #### Regulation .49 Resident Bedroom in Nursing Home. *COMAR 10.07.02.49* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home unless a waiver has been granted by the Office of Health Care Quality in accordance with Regulation .03G of this chapter. B. Bedroom Accommodations. (1) Bedroom. (a) A resident’s room shall have direct access to an exit in accordance with the requirements applicable to nursing homes specified in NFPA 101 Life Safety Code. (b) A room that opens into the kitchen may not be used as a resident bedroom. (c) A room may not be used as a resident bedroom if it can only be reached by passing through a kitchen. (d) Residents may not occupy rooms extending below the ground level. (e) No more than four individuals may occupy a multiple occupancy bedroom. (f) Residents’ beds may not be located near radiators, registers, or sources of draft. (g) Adequate storage space shall be provided in each bedroom to allow each resident to keep necessary items of clothing, including items that need to be hung. Adequate storage space shall be provided for residents’ personal possessions, including the storage of seasonal clothing. (h) All occupants of any bedroom shall be of the same sex, except in the case of a two-bed room occupied by: (i) Siblings; (ii) A parent and child; (iii) A married couple; or (iv) Consenting residents. (2) Bedroom — New Construction. A nursing home shall provide cubicle curtains and tracks in multiple occupancy bedrooms between beds to ensure privacy of residents. (3) Bedroom — Existing Construction. In an existing nursing home, curtains or screens shall be acceptable. C. Floor and Window Space. (1) Floors. (a) A distance of at least 3 feet shall be maintained between each bed. Beds are to be placed so that all sides of the bed are at least 18 inches from heating units. (b) The following shall be considered a minimum allowance of floor space: (i) 100 square feet, single-bed room; and (ii) 80 square feet, per bed, for multiple-bed rooms. (c) The following floor areas may not be included in the calculation of floor space: (i) Toilet rooms and bathing facilities; (ii) Closets; (iii) The floor area occupied by wardrobes, bureaus, or lockers, when permanently installed as part of walls or ceilings and as a permanent component of a bedroom; (iv) HVAC equipment, including any steam, water, or electrical supply or return lines that may run parallel to the floor or interrupt the floor surface; (v) Support columns, pipe chases, or other structures, whether free-standing or as an integral part of a wall; and (vi) The arc of any doors that open into the room, excluding closet doors. (d) The minimum horizontal dimensions of a bedroom shall be 10 feet to: (i) Facilitate the placement of beds as required in Regulation .44 of this chapter; and (ii) Maintain a minimum clearance of 3 feet at the foot of the bed. (e) In an existing nursing home, the usable floor area for rooms having a bedroom shall have a finished ceiling height of 8 feet. For a bedroom that has sloping walls, only 50 percent of the floor area with a ceiling height between 4 feet and 7 feet, 6 inches, shall be credited, provided that at least 50 percent of the total area of the bedroom has a ceiling height of 8 feet. (2) Windows. (a) The window area within each bedroom shall be at least 10 square feet per bed. The window opening shall be at least 28 inches so that the total area equals 10 square feet per bed. This is to allow entry of fire fighters, removal of smoke, and emergency evacuation. (b) The maximum height from the floor to the top of a window sill shall be 44 inches above the finished floor. (c) A portable window air-conditioning unit may not block window space. The installation of a portable air-conditioning unit shall be approved by the: (i) Local fire authorities; and (ii) Department. (d) If windows cannot be opened for ventilation, a central HVAC system shall be provided and maintained. (e) If windows can be opened, but the nursing home has concern over the window being opened due to resident safety issues and elopement, the window sash may be restricted by hardware as approved by the Department. D. Furnishings. (1) Furnishings. (a) The nursing home shall provide residents with their own bed. The bed shall be at least 36 inches wide and be substantially constructed. Rollaway type beds, cots, or folding beds may not be used. (b) Bed. (i) Each bed provided shall be in good repair, with a clean and comfortable standard size mattress and foundation. (ii) To avoid injury to the resident, the mattress and foundation shall fit the bed. (iii) Clean linen and a clean, comfortable pillow shall be provided. Extra pillows shall be available. (c) Bedroom Furniture. A resident shall be provided with the following furnishings, which shall be convenient to the resident: (i) Bedside stand with a drawer; (ii) Towel hanger; (iii) A comfortable chair; (iv) A chest of drawers with at least one locking drawer; (v) Enclosed space for hanging clothing; (vi) A wall mirror in each room, unless contraindicated by physician’s order; and (vii) A bedside lamp, over-bed lamp, or other directional light source for resident reading and bedside care. (d) Resident’s Personal Furnishings. (i) A nursing home shall develop policies and procedures to give residents the opportunity to use the resident’s own furnishings as detailed in this chapter. (ii) The nursing home shall make its resident’s personal furnishing policies available for review by residents and the resident’s representative. (iii) These policies shall address the condition of the personal furnishings, presence of insects or vermin, and overall safety to ensure that the use of the resident’s belongings does not create any safety or health issues. (iv) Personal furnishings that are allowed shall be appropriate for the resident’s use. (e) Windows shall be provided with shades or draperies adequate to control glare and maintain privacy. (f) Each living room for residents’ use shall be provided with a sufficient number of reading lamps, tables, and comfortable chairs or sofas. (2) Furnishings — New Construction. A bedroom shall be provided with a hand-washing sink with both hot and cold running water unless a toilet or bathroom facility with a sink is connected to the bedroom. (3) Medication Storage Cabinets. (a) Medication storage cabinets with locks shall be permitted for the storage of resident medications that do not require refrigeration within a resident bedroom. (b) Controlled medications to be stored within medication storage cabinets in a resident’s room shall be held within a separate compartment that is locked and inside of the larger medication storage cabinet in that room. #### Regulation .50 Body-Holding Room. *COMAR 10.07.02.50* A. Body-Holding Room — New Construction and Existing Nursing Home. (1) A body-holding room shall be equipped with ventilation by mechanical means at the same rate and specifications as designed for soiled linen sorting and storage areas. (2) A nursing home shall develop and implement a method for body-holding that minimizes the psychological effects on other residents. B. Body-Holding Room — New Construction. A body-holding room shall be located to facilitate quiet and unobtrusive ingress and egress of bodies, convenient to the elevator and with an isolated exit. C. Body-Holding Room — Existing Nursing Home. If a body-holding room is not provided, a holding area shall be designated that approximates the above conditions. #### Regulation .51 Resident Bathroom Amenities. *COMAR 10.07.02.51* A. Bathing. (1) There shall be at least one separate room or compartment with a bathtub, shower, or other bathing device, as approved by the Department, for every 15 licensed beds. (2) The compartment shall be large enough to accommodate: (a) The resident; (b) A caregiver; and (c) A wheelchair, shower chair, or shower bed. B. Toilets. (1) For every eight beds, there shall be at least one toilet enclosed in a separate room or stall. (2) Each floor shall have at least one toilet room large enough to: (a) Accommodate: (i) The resident; (ii) A wheelchair; and (iii) A caregiver; and (b) Permit toilet assistance or training. C. Sinks. (1) For every four licensed beds, there shall be at least one hand-washing sink. (2) For hand-washing purposes, there shall be a towel dispenser and a supply of paper towels and soap dispenser adjacent to each sink. #### Regulation .52 Equipment and Supplies for Bedside Care and Therapy. *COMAR 10.07.02.52* A. Needs of Residents. (1) There shall be sufficient equipment to meet the needs of the residents admitted. (2) The administrator shall obtain specific items required for individual cases where requested by the attending physician or medical director. (3) The Department may require that the nursing home have specific types of equipment based on the needs of the residents. (4) A nursing home shall establish and enforce a written preventive maintenance program to ensure that all resident care and therapy equipment is maintained in safe operating condition. B. Use of Hot Packs, Ice Packs, and Other Therapeutic Medical Devices. (1) Covers shall be placed on hot packs, ice packs and other temperature-related therapeutic medical devices before they are placed in a bed or on a resident. (2) The temperatures in the building, hot packs, and therapeutic equipment may not exceed 120°F or 49°C. (3) The use of hot and cold medical devices shall be: (a) Consistent with manufacturer’ guidelines and nursing home policies; and (b) Maintained and applied by trained staff. #### Regulation .53 Rehabilitation Facilities — Space and Equipment. *COMAR 10.07.02.53* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. General Requirements. (1) Space. (a) A nursing home shall provide adequate space to: (i) Receive, examine, and treat residents; (ii) Store supplies and equipment, including wheelchairs and stretchers; and (iii) Provide office space for the employed personnel to work. (b) A nursing home shall allot 75 square feet for treatment area per resident, based on peak treatment schedules. (c) A nursing home shall plan and arrange space for shared use by physical therapy and occupational therapy staff and residents, if scheduling permits. (d) A nursing home may distribute space in the following manner: (i) Storage space shall comprise at least 10 percent of the area designated for exercise and rehabilitation; and (ii) Office space shall be at least 110 square feet for one therapist, or 85 square feet per therapist if there are two or more. (2) Equipment. (a) Equipment shall allow for providing safe and effective resident care. (b) All electrical equipment shall be calibrated according to the manufacturer's guidelines and shall be serviced periodically as part of a preventive maintenance program. A sticker bearing the date of the most current inspection shall be affixed on each piece of equipment. (c) All electrical equipment shall be tested periodically for proper grounding, current leakage, and calibration where appropriate. (d) The operator’s instruction manual shall be available in a designated location or accessible electronically at all times. (e) All flammables shall be stored in compliance with NFPA 99 Health Care Facilities. (f) Adequate exhaust ventilation shall be provided when using vaporous materials or pollutants. (3) Toilet Facilities in Rehabilitation Area — New Construction. (a) A nursing home with rehabilitation areas shall provide a hand-washing sink and toilet which meet Guidelines for Design and Construction of Residential Health, Care, and Support Facilities standards for residents who use a wheelchair. (b) The nursing home shall be readily accessible to the residents receiving rehabilitative services. (c) Toilets and bathing rooms within a rehabilitation area shall be equipped with a nurse call system. #### Regulation .54 Dayroom and Dining Area. *COMAR 10.07.02.54* A. General Requirements. Resident Dining, Occupational Therapy, and Activities Program. The nursing home shall provide one or more attractively furnished areas of adequate size for resident dining, occupational therapy, and social activities. Activities space shall be of adequate size to meet the needs of the residents and shall be located on each floor occupied by residents. B. Dining Area. (1) A nursing home shall provide dining areas large enough to accommodate all residents who eat there at the same time. (2) There shall be an allowance of at least 12 square feet per resident. This allowance shall be substantially increased proportionate to the number of residents who use a wheelchair. (3) The height of tables provided in dining areas shall accommodate each resident using a wheelchair. C. Dayroom Area. Dayroom areas shall be provided that are: (1) Adequate for the residents located on each nursing care unit; and (2) Located convenient to the residents’ bedrooms. D. Multi-purpose Room. (1) The nursing home shall provide a multi-purpose room for dining, occupational therapy, physical therapy, and social activities. There shall be sufficient space to accommodate all activities without interfering with each other. (2) The nursing home shall set aside areas for residents’ dining and recreation that total at least 30 square feet per licensed bed for the first 100 beds, plus 27 square feet per licensed bed for all beds in excess of 100. (3) Areas that meet this requirement may include: (a) Reception areas; (b) Lobbies, portion not required for egress per NFPA 101 Life Safety Code, as are applicable to nursing homes; (c) Hair care; (d) Salon rooms; (e) Resident gift shops; (f) Theater; (g) Auditorium; (h) Spiritual worship; (i) Meditation areas; (j) Dayrooms; (k) Dining areas; (l) Libraries; and (m) No more than 50 percent of the floor area of all occupational therapy and physical therapy areas, and other areas as approved by the Department. #### Regulation .55 Dietetic Service Area. *COMAR 10.07.02.55* A. General Requirements. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Food Service Department. (1) The size and location of the food service area shall comply with COMAR 10.15.03. (2) A catered or satellite system shall be covered by a contract approved by the Department. (3) The vendor providing the food shall have a valid food service permit. C. Outside Service Entrance. A convenient outside service entrance shall exist to facilitate receiving food supplies and the disposal of waste. D. Restriction — Entry to Kitchen or Serving Pantry. A toilet room or sleeping room may not open directly into any kitchen or serving pantry. E. Limitations on Use of Kitchen. The kitchen may not be used as a passageway. It shall be used for no other purpose than activities connected with food service. F. Janitor Closet or Service Area. (1) Janitor Closet — New Construction. A janitor closet or service alcove for the exclusive use of food service areas shall be provided in, or adjacent to, the dietetic service department. (2) The janitor closet or service alcove shall be: (a) Equipped with: (i) A utility sink; (ii) Storage shelves; and (iii) A rack for hanging brooms and mops; and (b) Connected to mechanically operated exhaust ventilation. (3) The plumbing fixture for the utility sink within a janitor’s closet shall be provided with an approved back-flow prevention device. G. Space. (1) There shall be sufficient floor space in the food service department to permit all activities to function efficiently without overcrowding or increasing the risk for cross-contamination of food or equipment from soiled surfaces. (2) Minimum Space Requirements — New Construction. (3) Space — Existing Nursing Home. (a) A nursing home that holds full licensure as of the adoption date of these regulations shall be considered to have an adequate size dietetic service department. (b) Renovations of all kitchens shall be approved by the Department, which will consider modification of the minimum space requirement based on space available, costs, and type of service. (4) Aisle space between working areas shall be at least 3 feet, and aisle space for main traffic shall be at least 5 feet wide. (5) Ceiling height shall be at least 9 feet. (6) If the licensed capacity of a nursing home is increased, or if meals are provided to anyone outside of the nursing home from the food service area of the nursing home, the nursing home shall provide an additional food service area in accordance with this chapter. The additional food service area required when meals are provided to anyone outside of the nursing home is to be calculated by using the total number of individuals to whom meals are provided. (7) The kitchen space requirement as described in this regulation does not apply to occasional special functions such as picnics or dinners for residents, volunteers, families, or community groups as long as the nursing home certifies to the Department that providing meals for a special function will not adversely affect or detract from the timely provision of meals to the nursing home’s residents. H. Floor Pantries — New Construction. (1) There shall be at least one food service floor pantry per nursing care unit. (2) This area shall be of sufficient size to accommodate the equipment required for food preparation and service. (3) The equipment provided in food service floor pantries shall comply with the requirements of the local health department. (4) A food service floor pantry shall include the following: (a) Refrigerator; (b) Cabinets for dry storage and supplies; (c) Work space; (d) Sink for purposes other than hand-washing; (e) Hand-washing sink with soap dispenser and disposable paper towel dispenser; and (f) Except for trays that are assembled in the main kitchen and then distributed to the nursing care units, equipment to hold hot food if bulk foods are plated and served to the residents on the nursing care unit. (5) A food service floor pantry shall include the following additional equipment: (a) Toaster; (b) Ice-making machine or ice-storage container; (c) Work space for tray preparation; (d) Equipment to deliver completed trays; (e) Three-compartment sanitizing sink or dishwasher; (f) Cabinet for dry storage, supplies, and kitchenware; and (g) Storage for trays, tableware, flatware, and utensils. I. Equipment for Food Preparation and Distributions. (1) Adequate equipment for preparation, serving, and distribution of food shall be provided. (2) A dumbwaiter, elevator, or ramp shall be provided in a nursing home of more than one story where more than eight residents above or below the kitchen level receive bedside tray service. (3) Equipment to protect food from dust or contamination and to maintain food at proper temperature shall be provided to transport food to the residents. J. Dry Food Storage. (1) Food Storage Space. (a) Adequate space shall be provided to store food supplies. (b) The amount of storage space needed to store food depends on the frequency of deliveries. (c) It is recommended that 2 square feet per resident be provided and that the dry food storage area be located within easy access to the receiving area and the kitchen. (2) The storeroom shall be cool and well-ventilated. (3) All food supplies shall be stored off the floor and away from the wall to allow for cleaning. K. Refrigerated Storage. (1) Adequate refrigerated storage, refrigerators, and frozen food storage cabinets shall be provided and regulated to maintain temperatures prescribed in COMAR 10.15.03. (2) Food in storage shall be arranged so that new food items are stored behind old food items. (3) The oldest foods shall be used first, known as the first in, first out method. L. Mobile Food Carts. (1) All policies and procedures for the mobile food cart shall be approved by the Department and the nursing home’s local health department before implementation. (2) Policies and procedures shall address, at a minimum the following: (a) Identify how many staff members will assist with serving food items, pushing the mobile cart, and delivering meals to the residents; (b) Ensure proper food protection on three sides to protect the food; (c) Maintain proper temperature control, hot food at a minimum of 135°F and cold food maintained at a maximum of 41°F; (d) Record of temperatures before serving meals on each individual unit; (e) Ensure proper food temperatures; and (f) Hand washing. (3) The hand washing policy and procedures referenced in §L(2)(f) of this regulation shall include the following: (a) Use of a hand sanitizer in lieu of proper hand washing is not permitted; (b) Bare hands may not have direct contact with ready-to-eat food; (c) Hand washing shall be done before starting meal service on each individual unit; (d) When and at what location hand washing will be done; (e) Hand washing may not be done in resident rooms; (f) Access to a hand washing sink may not require the opening of a door; (g) The hand washing sink shall be in a central, unobstructed location; (h) Mobile hand sinks are acceptable as long as a written procedure to meet sanitation requirements is developed; (i) The hand sink shall be supplied with hot and cold water under pressure; (j) The unit shall be supplied with adequate waste containers to hold dirty water until dumping is done; and (k) The written procedure shall include the disposal of the dirty water. #### Regulation .56 Administrative Areas. *COMAR 10.07.02.56* A. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Administrative Areas — New Construction. (1) A nursing home shall provide a separate room or rooms for the administrator and administrative support staff. Sufficient areas shall be provided to accommodate all necessary office furniture, files, and other equipment and enable the safe storage of residents’ valuables. (2) In new construction, separate locker rooms and a toilet facility shall be provided for male and female employees in each nursing home. C. Administrative Areas — Existing Nursing Homes. (1) The nursing home shall provide an administrative area that is suitable for conducting business or discussing problems privately with the resident’s representative. (2) The nursing home shall provide a sufficient number of lockers that can be locked securely for all employees working at any one time, and shall provide for the employee use of toilet facilities. D. Lobby Area — New Nursing Home. A nursing home shall provide a lobby area that shall have: (1) Public toilets for both sexes, either separate or unisex, located conveniently to this area; (2) Access to telephone; and (3) Drinking fountains or other drinking water dispensers that meet Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. E. Employee Facilities — New Construction. In new construction, separate locker rooms and toilet facilities shall be provided for male and female employees in each facility. F. Employee Facilities — Existing Facilities. An existing nursing home shall: (1) Have a sufficient number of lockers that can be locked securely for all employees working at any one time; and (2) Provide for the employee use of toilet facilities at a convenient location. #### Regulation .57 Housekeeping Services, Pest Control, and Laundry. *COMAR 10.07.02.57* A. General Requirements. Unless otherwise indicated, all general requirements apply to both new construction and an existing nursing home. B. Staff. Sufficient housekeeping and maintenance personnel shall be employed to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner. C. Cleanliness and Maintenance. (1) The building and all its parts and facilities shall be kept in good repair, neat, and attractive. The safety and comfort of the residents shall be the primary consideration. (2) All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a type to allow frequent and easy cleaning. (3) The nursing home shall be kept free of unnecessary accumulations of personal possessions, boxes, trunks, suitcases, papers, unused furniture, bed clothing, linens, bric-a-brac, and similar items. (4) Storage areas shall be: (a) Kept clean and orderly; and (b) Readily accessible for: (i) Housekeeping; (ii) Maintenance; and (iii) Pest control servicing. (5) The grounds shall be kept clean, neat, attractive, and free of hazards. (6) Pest Control. The nursing home shall: (a) Be maintained free of insects and rodents by operation of an active pest-control program, either by use of maintenance personnel or by contract with a pest-control company; (b) Use and store toxic and flammable insecticides and rodenticides with care; (c) Ensure that usage of toxic and flammable insecticides and rodenticides conforms to the U.S. Environmental Protection Administration and Maryland Department of Agriculture requirements; (d) Be protected to prevent the entry and harborage of rodents and insects; (e) Install and effectively maintain: (i) Screen doors that fit tightly when closed; (ii) Easily adjusted closely fitted window screens; (iii) Rat-proofing devices; or (iv) Other approved deterrents; and (f) Effectively protect all openings to the outside against the entry of insects by: (i) Closed doors; (ii) Closed windows; or (iii) Other means. (7) Laundry Services. (a) A nursing home shall provide laundry service, whether on-site or off-site. (b) Laundry service shall be provided to meet the residents’ needs. (c) All laundry shall be processed and handled in a manner that prevents the spread of infections. Staff working in laundry shall be given personal protective equipment, including: (i) Disposable gloves; (ii) Masks; and (iii) Body coverings. (d) All laundry shall be processed through the use of sufficiently hot water, chemical agents, or a combination of the both, to remove or destroy infectious biological materials. (e) Clean and Soiled Areas. (i) There shall be a physical separation between the clean and soiled areas. (ii) The soiled area shall allow for sorting and washing soiled laundry. (iii) The clean area shall allow for drying and folding of clean laundry. (iv) All soiled areas within a laundry shall be connected to mechanically operated exhaust ventilation. (f) The system provided in laundries may not allow the spread of airborne contaminants to other parts of the nursing home that are occupied by residents, staff not working in the laundry, and the general public. (g) The plumbing fixtures for all water supply connections to washing machines and the plumbing fixtures for all utility sinks shall have an integrated atmospheric vacuum breaker or other approved back-flow prevention devices. #### Regulation .58 Resident Care Management System. *COMAR 10.07.02.58* A. Each comprehensive care facility and extended care facility shall establish and maintain a resident care management system. B. The resident care management system shall consist of three related components: (1) Resident status assessment and data gathering; (2) Care planning; and (3) Actions in response to care plan approaches. #### Regulation .59 Resident Status Assessment. *COMAR 10.07.02.59* A. A nursing home shall use the following forms and procedures for resident assessment as described in the CMS Manual System, Pub. 100-07 State Operations Provider Certification and in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual: (1) The Minimum Data Set (MDS) version as determined by the U.S. Department of Health and Human Services, Centers for Medicare and Medicaid Services, in Transmittal No. 22, referenced in §B of this regulation. (2) MDS Care Area Assessment process; and (3) Care plans. B. The nursing home shall complete all assessments in accordance with the provisions of 42 CFR §483.20, as amended. C. A nursing home certified for participation in Medicare or Medicaid shall complete and electronically submit the assessment to the Quality Improvement and Evaluation System (QIES) Assessment Submission and Processing (ASAP) system. The assessment shall: (1) Use a standard record layout format; (2) Use a data dictionary as identified by the automated data processing requirements; and (3) Pass standardized edits as defined by CMS and the State. D. A federally certified nursing home shall: (1) Encode assessment data as specified in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual; and (2) Transmit assessment data as specified in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual except as excluded in §E of this regulation. E. A nursing home licensed as a nursing home but not certified for participation in the Medicare or Medicaid Program shall comply with the CMS Manual System, Pub. 100-07 State Operations Provider Certification, and with RAI instructions in the CMS Long-term Care Facility Resident Assessment Instrument 3.0 User’s Manual, except that data may not be submitted electronically to the Department. #### Regulation .60 Care Planning. *COMAR 10.07.02.60* A. An interdisciplinary team shall complete or revise as necessary a resident-specific care plan for each resident within 7 calendar days following completion of assessments, including: (1) Admission assessment; (2) Annual assessment; (3) Quarterly assessment; and (4) Significant change in the resident’s condition. B. Care Plan Meeting. The nursing home shall, with the resident’s consent: (1) Give an interested and appropriate family member or resident’s representative 7 calendar days advance notice, in writing, of the location, date, and time of a care planning conference for a resident; (2) Strive to accommodate the schedules of invited family members and resident’s representatives when scheduling care plan meetings; and (3) Include an invitation for the family member or resident’s representative to attend the conference. C. The nursing home shall hold the care planning conference not later than 7 calendar days after completing the assessment, but may hold the conference sooner if agreed to by the resident, a family member, or a resident’s representative. D. Organization of Care Plan. (1) Resident’s problems and needs shall be identified, based upon the interdisciplinary assessment. The care plan shall address all of the resident’s special care requirements necessary to improve or maintain the resident’s status. The interdisciplinary team shall incorporate resident input into the care plan. (2) The team shall establish goals for each problem or need identified, or a combination thereof. The goals shall be realistic, practical, and tailored to the resident’s needs. Goal outcomes shall be measurable in time or degree, or both. (3) Approaches to accomplishing each goal shall be established. Approaches shall indicate the work to be done, who is to do it, and how frequently it is to be done. E. Disciplines shall update the care plans as the resident's assessment warrants, but not less than quarterly. F. Availability of Resident Care Plan. Resident care plans shall be readily available for use by all health care personnel. #### Regulation .61 Skin Record. *COMAR 10.07.02.61* A. The facility shall establish a skin care record documenting skin, hair, and nail condition on admission, if any abnormal conditions exist. B. The staff shall document progress of the condition or conditions weekly until the condition or conditions have healed. C. At any time that a skin condition persists for more than 7 days, staff shall add the condition to the skin record. #### Regulation .62 Geriatric Nursing Assistant Training Program. *COMAR 10.07.02.62* A. Nursing Home Responsibilities. (1) A nursing home shall conduct or arrange a geriatric nursing assistant training program for unlicensed personnel assigned to direct resident care duties. The Maryland Board of Nursing shall approve the geriatric nursing assistant training program curriculum. (2) A nursing home may not employ an individual as a geriatric nursing assistant until the individual has successfully completed a competency evaluation approved by the Maryland Board of Nursing. (3) A geriatric nursing assistant is deemed to satisfy the requirements of this chapter if that individual has successfully completed a training program approved by the State before July 1, 1990, or has been “grandfathered” under previous regulations. (4) Other persons hired as geriatric nursing assistants shall complete an approved geriatric nursing assistant training program within 120 days of employment. (5) The nursing home shall: (a) Record the satisfactory completion of the program in each employee’s personnel record; and (b) Give the employee a certificate signed by the program’s teacher or trainer as evidence of completion of the program. B. Course Structure. (1) The geriatric nursing assistant training program shall consist of 75 hours or more, and include at least 37.5 hours of classroom instruction and at least 37.5 hours of supervised clinical experience in long-term care. (2) The course content shall adhere to the geriatric nursing assistant training program curriculum approved by the Maryland Board of Nursing. #### Regulation .63 Paid Feeding Assistants. *COMAR 10.07.02.63* A. A facility may use a paid feeding assistant who has successfully completed a State-approved training course as described in §E of this regulation. B. Supervision. (1) A paid feeding assistant shall work under the supervision of a licensed nurse. (2) In an emergency, when the resident is fed in the resident's room, a paid feeding assistant shall use the resident call system to call a supervisory nurse for help. C. A nursing home that uses a paid feeding assistant shall ensure that the paid feeding assistant feeds only residents who do not have complicated feeding conditions including, but not limited to: (1) Difficulty swallowing; (2) Choking; (3) Recurrent lung aspiration; or (4) Tube or parenteral intravenous feedings. D. Protocol. The nursing home shall develop a protocol for selecting residents who are appropriate for feeding by a paid feeding assistant. The nursing home shall select eligible residents based on the: (1) Charge nurse's current assessment of the resident; (2) The resident's latest Minimum Data Set (MDS) assessment; and (3) The resident's plan of care. E. State-Approved Training. A State-approved training course for paid feeding assistants shall consist of at least 8 hours of training that includes: (1) Feeding techniques; (2) Assistance with feeding and hydration; (3) Communication and interpersonal skills; (4) Appropriate responses to resident behavior; (5) Safety and emergency procedures, including the Heimlich maneuver; (6) Infection control; (7) Resident rights; (8) Recognizing changes in a resident's behavior that are inconsistent with the resident's normal behavior and the importance of reporting these changes to a supervisory nurse; and (9) Successful completion of a two-part test that includes a: (a) Written test with a passing score of 80 percent; and (b) Demonstration of proper feeding skills performed on a resident while being observed. F. The feeding assistant training may be taught by a: (1) Registered nurse and supplementary professional instructors; (2) Licensed dietitian-nutritionist; (3) Licensed physical therapist; (4) Licensed speech therapist; or (5) Licensed occupational therapist. G. The facility shall maintain a record of all paid feeding assistants who have successfully completed a feeding assistance course. #### Regulation .64 Quality Assurance Program. *COMAR 10.07.02.64* A. A nursing home shall establish an effective quality assurance program that includes components described in this regulation and Regulation .65 of this chapter. B. The nursing home shall appoint a qualified individual to manage quality assurance activities within the nursing facility. C. The nursing home shall establish a quality assurance committee that includes at least: (1) The nursing home director of nursing; (2) The nursing home administrator; (3) A social worker; (4) The nursing home medical director; (5) A dietitian-nutritionist; and (6) A geriatric nursing assistant at the nursing home. D. The Quality Assurance Committee. The quality assurance committee shall: (1) Designate an individual to oversee committee activities; (2) Meet monthly to carry out quality assurance activities; (3) Help develop and approve the nursing home’s quality assurance plan; (4) Submit the quality assurance plan to the Department’s Office of Health Care Quality at the time of initial application for licensure; (5) Submit any changes to the quality assurance plan to the Office of Health Care Quality within 30 days of the changes; (6) Review and approve the facility's quality assurance plan at least yearly; and (7) Prepare monthly reports for the ombudsman, family council, and residents' council. E. Quality Assurance Records. For the purposes of ensuring implementation and effectiveness of the quality assurance program, the facility shall make quality assurance records and documents available to the Office of Health Care Quality. F. Quality Assurance Committee — Non-members. Anyone not on the committee shall be informed of how to present and submit concerns to: (1) The committee; (2) A member of the resident council; or (3) A member of the family council if one exists. #### Regulation .65 Quality Assurance Plan. *COMAR 10.07.02.65* A. The nursing home’s quality assurance committee shall develop and implement a quality assurance plan that includes procedures for: (1) Concurrent review; (2) Ongoing monitoring; (3) Resident complaints; (4) Accidents and incidents; and (5) Abuse and neglect. B. Concurrent Review. The quality assurance plan shall include: (1) The procedures for conducting concurrent review of each resident including: (a) Criteria to determine any change in a resident's condition; (b) A method to document the concurrent review; and (c) Identification of the licensed nurse or nurses conducting the concurrent review; (2) The procedures to evaluate clinical data for any resident with a change in condition including at least: (a) Medications; (b) Laboratory values; (c) Intake and output; (d) Skin breakdown; (e) Noted weights; (f) Appetite; (g) Injuries resulting from accidents or incidents; and (h) Any other relevant parameters that may affect the resident's physical or mental status; (3) Procedures to take action when there is a change in the resident’s condition, including: (a) Communicating changes to the director of nursing or the resident’s attending physician; and (b) Changing the resident’s plan of care as necessary; and (4) Procedure for referring data to the quality assurance committee, when appropriate. C. Ongoing Monitoring. The quality assurance plan shall include: (1) A description of the measurable criteria for ongoing monitoring of all aspects of resident care including: (a) Medication administration; (b) Prevention of pressure ulcers, dehydration, and malnutrition; (c) Nutritional status and weight loss or weight gain; (d) Accidents and injuries; (e) Unexpected death; and (f) Changes in physical or mental status; (2) The methodology for collecting data; (3) The methodology for evaluating and analyzing data to determine trends and patterns; (4) A description of the thresholds and performance parameters that represent acceptable care for the measured criteria; (5) Time frames for referral to the quality assurance committee; (6) A description of the plan for follow-up to determine effectiveness of the recommendations; and (7) A description of how the quality assurance activities will be documented. D. Resident Complaints. The quality assurance plan shall include: (1) A description of a complaint process that effectively addresses resident and family concerns including: (a) The designated person or persons and their phone numbers to receive complaints and concerns; (b) The method to be used to acknowledge complaints received; and (c) The time frames for investigating complaints, depending on the nature or seriousness of the complaint; (2) A description of a logging system that will be used including the: (a) Name of the complainant; (b) Date the complaint was received; (c) Nature of the complaint; and (d) Date that the complainant was notified of the disposition or resolution of the complaint; and (3) The procedures for: (a) Notifying residents of their right to file a complaint with the Office of Health Care Quality; (b) Informing residents, families, or guardians of the complaint process upon admission; and (c) Posting the complaint process or making it available without the need to request it. E. Accidents and Injuries. The quality assurance plan shall include: (1) A definition of accident and injury that is appropriate to the type of resident served by the nursing home; (2) A description of the process for reporting accidents and injuries including: (a) Who shall report incidents; (b) The time frame for reporting incidents; and (c) The procedure for reporting incidents; (3) A policy statement that ensures that incidents can be reported without fear of reprisal; (4) A description of how internal investigations of accidents and injuries will be handled including: (a) Assessment of any injury; (b) Interview of the resident, staff, and any witnesses; (c) Review of any relevant records including the resident's medical records, discharge summary, hospital records, etc.; and (d) Time frames for conducting the investigation; (5) A description of the process for notifying a family or guardian about the incident; (6) A description of the process for the ongoing evaluation of patterns and trends in accidents and injuries; and (7) A description of how relevant information will be referred to the quality assurance committee. F. Abuse and Neglect. The quality assurance plan shall include: (1) The process for implementing COMAR 10.07.09.15 concerning abuse of residents; (2) A description of the process for providing immediate notification to the family, guardian, or responsible party about the incident; (3) A description of the process for the ongoing evaluation of validated incidents of abuse and neglect to determine patterns and trends; and (4) A description of how relevant information will be referred to the quality assurance committee. #### Regulation .66 Relocation of Residents. *COMAR 10.07.02.66* A. The facility shall develop and implement a written plan to provide for the smooth and orderly transfer of residents if the facility closes. B. The plan for relocation shall include: (1) A description of how residents, families, or guardians will be notified and by whom; (2) Sample letters and other documents that will be used during a closure; (3) Procedures for notifying Medicaid and other payment sources; (4) Procedures for notifying the Office of Health Care Quality; and (5) A mechanism to ensure the safe and orderly transfer of residents that takes into account: (a) Roommates, medical care, religious affiliation, geographical location and payer source; (b) Proper assessment and identification of any special needs; (c) Transfer of medical information and records; and (d) Transfer of personal property. #### Regulation .67 Posting of Staffing. *COMAR 10.07.02.67* A. A nursing home shall post a notice on each floor or unit of the nursing home, for each shift, a notice that gives the ratio of licensed and unlicensed staff to residents. B. The posting on each floor shall include: (1) Names of the staff members on duty and the room numbers of the residents to whom each is assigned; (2) Name of the charge nurse or person who is in charge of the unit; (3) If the person in charge is not a registered nurse, the name of the registered nurse responsible for the unit; and (4) Name of the medicine aide or person responsible for medication administration. C. The posting shall be on a form provided or approved by the Department. D. A record of the posting shall be retained for 1 year. #### Regulation .68 Sanctions. *COMAR 10.07.02.68* A. If a deficiency exists, the Department, in addition to the sanctions set forth in this regulation and Regulations .67—.74 of this chapter, may: (1) Restrict the number of residents the nursing facility may admit in accordance with Health-General Article, §19-328, Annotated Code of Maryland; (2) Require the establishment of an escrow account in accordance with Health-General Article, §19-362, Annotated Code of Maryland; (3) Direct the licensee to correct the deficiencies in a specific manner or within a specific time frame, or both, to protect the health and welfare of residents; (4) Enter into an agreement with the licensee establishing certain conditions for continued operation, including time limits for compliance; and (5) In accordance with Health-General Article, §19-1405, Annotated Code of Maryland, appoint an independent State monitor who is qualified on the basis of education and experience to oversee correction of the deficiencies. B. State Monitor. (1) The duties of the State monitor shall be specified in a written agreement between the Department and the State monitor and shall include but are not limited to: (a) Conducting periodic on-site inspections to assess a nursing facility's compliance with State and federal regulations; (b) Making recommendations to achieve compliance with State and federal regulations; and (c) Issuing written reports to the Department and the nursing home, detailing the findings of the on-site inspections and the status of requirements and recommendations for the nursing home to achieve compliance. (2) The State monitor shall function for a period of time specified by the Department. The facility may request rescission or modification of the duration of the State monitor's appointment at intervals of not less than 120 days from the date of appointment. (3) The State monitor may not be an employee of the Department. (4) The State monitor's salary shall be: (a) Paid directly by the nursing facility; and (b) At least equivalent to the prevailing salary paid by nursing facilities for an individual with similar education and experience. C. If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction, the Secretary may revoke the license as permitted by applicable law. D. A licensee that disagrees with the imposition of a sanction under §A(1) or (5) of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .78 of this chapter. A licensee that disagrees with the imposition of a sanction under §A(2) of this regulation may appeal the Secretary’s action in accordance with Health-General Article, §§19-364 and 19-367, Annotated Code of Maryland. #### Regulation .69 Mandated Staffing Pattern. *COMAR 10.07.02.69* A. When the Department determines that a deficiency or deficiencies exist, the Department shall notify the nursing facility of the deficiency or deficiencies and may either: (1) Mandate a staffing pattern which specifies the number of personnel or personnel qualifications, or both; or (2) Permit the facility the opportunity to correct the deficiencies by a specific date. B. If the facility does not correct the deficiency or deficiencies, the Department has the authority to specify the number of personnel or personnel qualifications, or both. C. The facility shall comply with the Department's mandated staffing pattern and notify the Department, in writing, when the staffing pattern has been implemented. D. A mandated staffing pattern shall be in effect for the period of time specified by the Department. A facility may request rescission or modification of the staffing pattern at intervals of not less than 60 days from the date of imposition of the staffing pattern. E. A facility has the right to appeal a mandated staffing pattern in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. However, the mandated staffing pattern shall be maintained during the pendency of the appeal. #### Regulation .70 Civil Money Penalties — Imposition. *COMAR 10.07.02.70* A. A civil money penalty may be imposed when: (1) A deficiency exists; or (2) An ongoing pattern of deficiencies exist in a nursing facility. B. In determining whether a civil money penalty is to be imposed, the Department shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the residents of the nursing facility caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of, the nursing facility to correct the deficiency or deficiencies; (5) A nursing facility's prior history of compliance in general and specifically with reference to the cited deficiencies; and (6) Such other factors as justice may require. C. When the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the nursing facility of the deficiency or deficiencies and may: (1) Impose a per day civil money penalty until sustained compliance has been achieved; (2) Permit the facility the opportunity to correct the deficiencies by a specific date; or (3) Impose a per instance civil money penalty for each instance of violation. D. When the Department permits a facility the opportunity to correct the deficiencies by a specific date, and the facility fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. E. When a civil money penalty is imposed, the Department shall issue an order which includes the: (1) Deficiency or deficiencies on which the order was based; (2) Amount of civil money penalty to be imposed; and (3) Manner in which the amount of civil money penalty was calculated. F. An order issued pursuant to §E of this regulation is void unless issued within 60 days of the inspection or reinspection at which the deficiency or deficiencies are identified. #### Regulation .71 Civil Money Penalties — Amount of Penalty. *COMAR 10.07.02.71* A. A civil money penalty imposed under this chapter for potential for more than minimal harm deficiencies may not exceed: (1) $10,000 per instance; or (2) $1,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained. B. A civil money penalty imposed under this chapter for actual harm deficiencies may not exceed: (1) $10,000 per instance; or (2) $5,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained. C. A civil money penalty imposed under this chapter for a serious and immediate threat may not exceed: (1) $10,000 per instance; or (2) $10,000 per day for an ongoing pattern of deficiencies until correction of the deficiencies has been verified and sustained compliance has been maintained. D. In setting the amount of a civil money penalty, the Department shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The degree of risk to the health, life, or safety of the residents of the nursing facility caused by the deficiency or deficiencies; (3) The efforts made by, and the ability of, the nursing facility to correct the deficiency or deficiencies; (4) Current federal guidelines for civil money penalties; (5) Whether the amount of the proposed civil money penalty will jeopardize the financial ability of the nursing facility to continue operating as a nursing facility; (6) A nursing facility's prior history of compliance; and (7) Such other factors as justice may require. #### Regulation .72 Civil Money Penalties — Effective Date and Duration of Penalty. *COMAR 10.07.02.72* A. Per Instance Civil Money Penalty. The effective date may be as early as the date that the deficiency or deficiencies upon which the civil money penalty is based first occurred. B. Per Day Civil Money Penalty. (1) The daily civil money penalty starts to accrue as of the date of the visit that identifies the deficiency or deficiencies upon which the civil money penalty is based. (2) The accrual of the daily civil money penalty ceases when correction of the deficiency or deficiencies upon which the civil money penalty was based has been verified and the facility has maintained sustained compliance. #### Regulation .73 Civil Money Penalties — Payment of Penalty/Establishment of Escrow Account. *COMAR 10.07.02.73* A. A civil money penalty payment is due 15 calendar days after: (1) The time period for requesting a hearing has expired and a request for hearing was not received; or (2) Receipt of a written request from the facility to waive its right to a hearing and reduce the amount of the civil money penalty by 40 percent provided the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty. B. Within 15 days of the request for an appeal by a nursing facility, the nursing facility shall deposit the amount of the civil money penalty in an interest-bearing escrow account. If a per day civil money penalty is in effect at the time the escrow account is established, the amount owed on that date shall be deposited into the escrow account. The nursing facility shall bear any cost associated with establishing the escrow account, and the account shall be titled in the name of the nursing facility and the Maryland Department of Health as joint owners. C. When the Secretary issues the final decision of the Department: (1) If the decision upholds the imposition of the full civil money penalty, the escrow funds, in addition to the amount of any per day civil money penalty that has accrued after the initial deposit into the escrow account, shall be released to the Department within 15 days from the date of the decision; (2) If the decision upholds the imposition of a civil money penalty, but reduces the amount of the civil money penalty, the amount due the Department shall be released to the Department with accrued interest within 15 days of the date of the decision and the balance will be released to the nursing facility within 15 days of the date of the decision; or (3) If the decision reverses the imposition of the civil penalty, the escrow funds shall be released to the nursing facility with accrued interest within 15 days of the decision. D. If a facility does not release or pay the civil money penalty to the Department after the Secretary has issued a final decision upholding the civil money penalty and after notice to the facility, the State may deduct the amount of the civil money penalty from any sum that is then or later owed by the State to the facility, pursuant to State Finance and Procurement Article, §7-222, Annotated Code of Maryland. #### Regulation .74 Civil Money Penalties — Hearings. *COMAR 10.07.02.74* A. A licensee aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary has the burden of proof with respect to the imposition of civil money penalties. C. The Office of Administrative Hearings shall render a decision within 10 working days of the hearing. #### Regulation .75 Criminal Penalties. *COMAR 10.07.02.75* A. A person maintaining or operating a nursing home without a license is guilty of a misdemeanor, and, on conviction, is liable for a fine of not more than $1,000 for the first offense and not more than $10,000 for each subsequent conviction in accordance with Health-General Article, §19-358, Annotated Code of Maryland. B. Each day that the nursing home continues to operate without a license after the first conviction is a subsequent offense and may subject the operator to further criminal prosecution. C. A person maintaining and operating a nursing home that is in violation of this chapter is guilty of a misdemeanor, and, on conviction, shall be fined not more than $1,000 under the authority of Health-General Article, §19-359, Annotated Code of Maryland. D. Each day that the nursing home operates after the first conviction, without correction of the cited violation, is considered a subsequent offense and may subject the operator to further prosecution. #### Regulation .76 Emergency Suspension. *COMAR 10.07.02.76* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action pursuant to State Government Article, §10-405(b), Annotated Code of Maryland. B. The Department shall deliver a written notice to the nursing facility: (1) Informing the nursing facility of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the nursing facility of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is suspended by emergency action: (1) The nursing facility shall immediately return the license to the Department; and (2) The licensee shall notify the residents or representatives of the residents of the suspension and make every reasonable effort to assist them in making arrangements for transfer to other appropriate living arrangements. E. In the event of an emergency suspension, the Department may assist in the relocation of residents. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .59 of this chapter. G. The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .59 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. H. If the Secretary's final decision does not uphold the emergency suspension, the nursing facility may resume operation. #### Regulation .77 Denial or Revocation of License. *COMAR 10.07.02.77* A. Denial or Revocation of License. The Secretary, for cause shown, may notify the nursing facility of the decision to revoke or deny the nursing facility's license. The denial or revocation shall be stayed if a hearing is requested. B. The Department shall notify the nursing facility in writing of the following: (1) The effective date of the denial or revocation; (2) The reason for the denial or revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the denial or revocation; (4) That the nursing facility is entitled to a hearing if requested, and to be represented by counsel; (5) That the nursing facility shall stop providing services on the effective date of the denial or revocation if the nursing facility does not request a hearing; (6) That the denial or revocation shall be stayed if a hearing is requested; and (7) That the nursing facility is required to surrender its license to the Department if the denial or revocation is upheld. C. The licensee shall notify the residents or residents' representatives of any final denial or revocation and make every reasonable effort to assist them in making other living arrangements. The Department may assist in the relocation of residents. D. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .59 of this chapter. #### Regulation .78 Hearings. *COMAR 10.07.02.78* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. #### Regulation .79 Health Care Quality Account. *COMAR 10.07.02.79* A. The Department shall establish a health care quality account in the Department. B. The health care quality account shall be funded by civil money penalties paid by nursing homes. C. The Department shall use funds from the health care quality account to improve the quality of care in nursing facilities. D. Expenditure of funds may include, but are not limited to the following: (1) Funding for the establishment and operation of a demonstration project; (2) A grant award; (3) Relocation of residents in crisis situations; (4) Provision of educational programs to nursing facilities, the Office of Health Care Quality, other government, professional, or advocacy agencies, and consumers; and (5) Any other purpose that will directly improve quality of care. E. Suggestions for the use of funds may be submitted to the Department from: (1) Members of the public; (2) Advocacy organizations; (3) Government agencies; (4) Professional organizations including trade associations; (5) Nursing homes; and (6) Nursing home associations. F. Decision on Expenditure of Funds. (1) The Department, in its sole discretion, shall decide how to spend funds from the health care quality account. (2) The Department's decision to spend funds or not to spend funds for a specific project or purpose is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and therefore is not subject to appeal. #### Regulation .80 Financial Disclosure. *COMAR 10.07.02.80* A. A licensee shall have financial resources in accordance with this regulation in order to: (1) Satisfy obligations; and (2) Ensure at all times the delivery of essential care and services, such as nursing, dietary services, or utilities. B. A licensee shall notify the Secretary of significant adverse changes in financial condition which reasonably could be anticipated to adversely affect the delivery of essential care and services. These adverse changes include, but are not limited to, the following situations: (1) The facility fails to maintain the facility's utilities or a quantity of supplies, including nursing, dietary, pharmaceutical, or other care and service supplies, sufficient to meet the needs of the residents; (2) The facility is unable to meet its employee payroll or benefits obligations; (3) The license holder or entity legally authorized to act on behalf of the license holder receives notice that a judgment or tax lien of at least $5,000 has been filed, recorded, or levied against the facility or any of the assets of the facility or the license holder and the judgment or tax lien is not satisfied, or an appropriate extension has not been obtained, within 30 days after receipt of the notice; (4) A financial institution refuses to honor facility-operation-related checks or other financial instruments issued by the license holder or entity legally authorized to act on behalf of the license holder, and: (a) The cumulative amount of the checks or financial instruments is $5,000 or more; and (b) The checks or financial instruments are not honored or replaced to the satisfaction of the holders of the instruments within 10 working days after the holders have notified the license holder, operator, administrator, manager, or the person authorized to issue the instrument of the dishonored items; (5) The license holder, or entity legally authorized to act on behalf of the license holder fails to make timely payments of any facility-related tax of at least $1,000, and fails to satisfy the tax within 30 working days after the date the tax becomes delinquent; (6) The license holder, owner of 25 percent of the license holder's assets, or facility management company files a voluntary bankruptcy petition, or a creditor files an involuntary bankruptcy petition against the facility management company, license holder, or owner of 25 percent or greater of the license holder's assets; (7) A court appoints a bankruptcy trustee for the facility; (8) A person seeking appointment of a receiver for the facility files a petition for the appointment of a receiver for the facility in any jurisdiction; (9) The license holder, or person legally authorized to act on behalf of the license holder is unable to meet conditions of a facility-operation-related loan or material debt covenant unless the loan or material debt covenant has been waived or cured, and that inability has led to a recall by the issuing entity; or (10) The license holder, or entity legally authorized to act on behalf of the license holder, is delinquent on more than $5,000 of facility-related contractual obligations or vendor contracts that affect essential care and services for residents and has not cured the delinquency within 10 working days after receipt of notice from the creditor or creditors to pay the debt. C. The license holder shall notify the Secretary in writing of a significant adverse change in its financial condition as required by §B of this regulation within 72 hours after the license holder becomes aware of, or reasonably should have become aware of, the change in its financial condition. D. The license holder's notice required by §B of this regulation shall include a description of: (1) The specific significant adverse change in financial condition; (2) How the significant adverse change in financial condition affects or may affect the license holder's ability to deliver essential care and services; and (3) The actions the license holder has taken to address the significant adverse change in financial condition. E. The license holder shall fax, email, or hand-deliver the notice required in §B of this regulation to the Department's Office of Health Care Quality, and the notice shall be kept on file with a copy of the delivery confirmation. F. The license holder shall provide any other information, unless prohibited under applicable laws, requested by the Office of Health Care Quality to substantiate continued compliance with the requirements of this regulation within 30 days after the request. Failure to comply with the requirements of this regulation may result in the Secretary imposing one or more sanctions, as appropriate, from Regulations .51—.58 of this chapter against the facility. G. The information submitted pursuant to §D of this regulation is confidential and may not be disclosed without the consent of the licensee. H. Unless disclosure of the information is otherwise prohibited by applicable law, the provisions of §G of this regulation do not apply to: (1) The holder of a license that has been suspended or revoked; or (2) The use of information in: (a) An administrative proceeding initiated by the Department; or (b) A judicial proceeding. ### Chapter 03 — Health Care Staff Agencies **Authority:** Health-General Article, §2-104 and Title 19, Subtitle 20, Annotated Code of Maryland **Administrative History:** Effective date: December 17, 2007 (34:25 Md. R. 2211) **Administrative History:** Chapter revised effective September 15, 2014 (41:18 Md. R. 1009) **Administrative History:** Regulation .05A, D amended effective December 21, 2015 (42:25 Md. R. 1542); August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05D amended effective June 5, 2017 (44:11 Md. R. 524) **Administrative History:** Regulation .06B amended effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 Purpose. *COMAR 10.07.03.01* A. The purpose of this chapter is to set minimum standards for licensure of health care staff agencies providing services in Maryland. B. The regulations of this chapter do not preclude a health care staff agency from operating with independent contractors. #### Regulation .02 Definitions. *COMAR 10.07.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abuse. (a) “Abuse” means: (i) The nontherapeutic infliction upon a resident of physical pain or injury; or (ii) A persistent course of conduct intended to produce, or resulting in, mental or emotional distress to a resident, for example, verbal intimidation of a resident. (b) “Abuse” does not mean the performance of an accepted medical procedure ordered by a physician or administered by another health care professional practicing within the scope of the physician's or health care professional's license. (2) “Agency” means a health care staff agency. (3) Allied Health Care Field. (a) “Allied health care field” means a healthcare profession subject to licensure under Health Occupations Article, Annotated Code of Maryland. (b) “Allied health care field” does not include the healthcare profession of physician assistant. (4) “Board” means a health occupation licensing board authorized to license, certify, and discipline a health care practitioner in accordance with the Health Occupations Article. (5) “Client facility” means a health care facility that contracts with a health care staff agency for the referral of health care practitioners. (6) “Deficiency” means any failure of the health care staff agency to meet the requirements of Health-General Article, Title 19, Subtitle 20, Annotated Code of Maryland, or any rule or regulation that the Secretary adopts under that subtitle. (7) “Department” means the Department of Health. (8) “Health care facility” means a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland. (9) Health Care Practitioner. (a) Except as provided in §B(9)(b) of this regulation, “health care practitioner” means any individual licensed or certified under Health Occupations Article, Annotated Code of Maryland, who practices in an allied health care field. (b) “Health care practitioner” does not include: (i) An acupuncturist; (ii) A dentist; (iii) A nurse anesthetist; (iv) A nurse midwife; (v) A nurse practitioner; (vi) A pharmacist; (vii) A physician; or (viii) A podiatrist. (10) “Initially providing or referring” means the first time a health care staff agency provides or refers a particular health care practitioner to a health care facility. (11) “Licensee” means the person, association, partnership, corporation, limited-liability company, or other entity to which a license is issued. (12) “Neglect” means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. (13) Health Care Staff Agency. (a) “Health care staff agency” means any person, firm, corporation, partnership, or other business entity engaged in the business of referring health care practitioners as employees or independent contractors to render temporary health care services at a health care facility in the State. (b) “Health care staff agency” does not include: (i) A health care staff agency operated by a health care facility or its affiliates solely for the purpose of procuring, furnishing, or referring temporary or permanent health care practitioners for employment at that health care facility or its affiliates; (ii) A home health agency regulated under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; or (iii) Any health care practitioner procuring, furnishing, or referring their own services to a health care facility without the direct or indirect assistance of a health care staff agency. (14) “Office” means the Office of Health Care Quality in the Department. (15) “Responsible party” means the individual at a health care staff agency who controls the day-to-day operation of the health care staff agency. (16) “Secretary” means the Secretary of Health. #### Regulation .03 License Required. *COMAR 10.07.03.03* A. A person, firm, corporation, partnership, or other business entity may not maintain or operate a health care staff agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter. B. An agency shall post its license conspicuously onsite so that it is clearly visible to the general public. C. An out-of-State agency providing services in this State shall have a current Maryland license conspicuously posted at the: (1) Office in this State where the agency conducts its day-to-day operations, if the agency operates an in-State office; or (2) Agency's records repository that is located in this State, if the agency utilizes a records repository. #### Regulation .04 Restrictions of License. *COMAR 10.07.03.04* A. A person operating an agency may not use the term “health care staff agency” in its advertising without first obtaining a license from the Secretary. B. A license is valid only in the name of the licensee to whom the license is issued and is not subject to sale, assignment, or other transfer. C. If the agency ceases to operate for any reason, the license is void and the licensee shall immediately return the license to the Department. #### Regulation .05 Licensing Procedure. *COMAR 10.07.03.05* A. Application for Licensure. (1) A person desiring to refer a health care practitioner to a health care facility to render temporary health care services in this State shall file an application with the Secretary, on a written or electronic form provided by the Secretary. (2) The application for licensure shall contain the agency's business name, address, telephone number, and responsible party. (3) Along with the application, the applicant shall submit a copy of the agency’s policies and procedures as specified in Regulation .08 of this chapter. B. Additional Requirements. (1) The applicant shall: (a) Demonstrate compliance with all applicable federal, State, and local laws and regulations; and (b) Submit all documentation requested by the Department that is relevant to the applicant's ability to operate an agency in compliance with this chapter, including documentation of any: (i) Past or current operation of a health-related facility or an agency; (ii) Prior denial, suspension, or revocation of a license of certification to provide care to third parties; and (iii) Felony conviction of the applicant or anyone with direct or indirect ownership interest in the agency. (2) The Secretary may require an applicant to submit information to demonstrate the applicant's financial ability to operate an agency in compliance with this chapter. C. Duration of License. An agency's annual license shall expire on the annual anniversary of the date the license was originally issued unless the license is renewed for a 1-year term. D. License Renewal. (1) At least 1 month before the current license expires, the Office shall send to the agency, by first-class mail to the last known address of the agency, a renewal notice that states: (a) The date on which the current license expires; (b) The date by which the renewal application shall be received by the Office for the renewal to be issued and mailed before the license expires; and (c) That no renewal fee is required. (2) Before a license expires, the agency may renew its license for an additional term by submitting a renewal application on a written or electronic form provided by the Secretary, if the agency: (a) Otherwise is entitled to be licensed; and (b) Provides updates, if any, to the agency's policies and procedures as specified in Regulation .09 of this chapter. (3) Failure to Renew License. When an agency fails to renew its license, the agency shall: (a) Immediately stop referring personnel to health care facilities; and (b) Notify health care facilities where personnel are currently referred that the agency no longer has a valid operating license. E. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: (1) Approve the application unconditionally; (2) Approve the application conditionally, which may include, among other conditions, requiring the applicant to use the services of a management firm approved by the Secretary; or (3) Deny the application. F. Nursing Staff Agency Licensees. (1) Effective September 15, 2014, a person holding a nursing staff agency license who is in good standing and refers only nursing personnel shall be deemed to meet the requirements for issuance of a health care staff agency license. (2) A person holding a nursing staff agency license who wishes to expand their referrals to other health care practitioners in addition to nursing personnel shall first obtain a new health care staff agency license. G. Rights of Applicant if License is Revoked or Denied. (1) Denial of License. The Secretary shall inform the applicant of the reasons for refusal to issue a license. (2) Revocation of License. The Secretary may, for cause shown, revoke or refuse to reissue any license. (3) A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .17 of this chapter. #### Regulation .06 Changes to Licensure Information. *COMAR 10.07.03.06* A. A licensee shall notify the Department of any change in agency ownership, name, or address within 30 calendar days of the change. B. Any change in agency ownership, name, or address requires the issuance of a new license. If the sale, transfer, assignment, or lease of an agency causes a change in the person or persons who control or operate the agency, the agency shall be considered a “new agency” and the new owner shall comply with all regulations of this chapter when applying for a new license. C. If the licensee fails to notify the Office of the changes in §A of this regulation, the Office may impose a fine of $100. #### Regulation .07 Inspections by the Department. *COMAR 10.07.03.07* A. The Department or its designee may conduct announced or unannounced licensure or complaint inspection visits to the agency's office or records repository, if utilized by an out-of-State agency, to ensure compliance with the requirements of this chapter. B. The agency's office or records repository, if utilized by an out-of-State agency, shall be available during normal business hours for announced or unannounced inspections by the Department or its designee. C. An agency with offices out-of-State shall comply with the regulations of this chapter and shall reimburse the Department for reasonable travel expenses incurred in conducting out-of-State inspections. D. An agency shall maintain records to support compliance with the regulations of this chapter. The responsible party of the agency shall provide all records requested by the Office not later than 24 hours after the request. #### Regulation .08 Administration. *COMAR 10.07.03.08* A. The agency shall develop, document, and implement policies and procedures. B. Policies and procedures shall include, but are not limited to: (1) Selecting and verifying the credentials of a health care practitioner referred by the agency; (2) Validating the experience of a health care practitioner prior to referral by the agency; (3) Tracking and acting on serious or life-threatening complaints received by a client, facility, or the client facility's agent; (4) Reporting of an action or condition performed by a health care practitioner as required under Regulation .09C of this chapter; (5) Verifying the following: (a) A health care practitioner referred by the agency is of satisfactory health status and has received the necessary testing and immunization as required or requested by the client facility; (b) Drug screening of a health care practitioner is performed before referral by the agency, if the client facility requires drug screening for facility employees; (c) Drug testing of a health care practitioner referred by the agency is performed, if there is probable cause to perform a drug test or if a client facility requests a drug test; (d) Criminal background checks of a health care practitioner are performed before referral by the agency, if the client facility requires criminal background checks for facility employees; (e) The references of a health care practitioner referred by the agency; (f) A health care practitioner referred by the agency has I-9 status that permits them to legally work in the United States; and (g) A health care practitioner has active licensure or certification with the Board; and (6) Investigating a complaint or grievance presented to an agency by the client facility, an individual receiving services, a representative of the individual receiving services, or any concerned individual that includes a: (a) Description of how and to whom to file a complaint within the agency; (b) Description of how and to whom to file a complaint with the Office; (c) Commitment to conduct a thorough investigation into any allegation against individuals referred by the agency; and (d) Mechanism for making completed investigation reports available to the Department immediately upon request during inspections. #### Regulation .09 Referral and Reporting Health Care Practitioners. *COMAR 10.07.03.09* A. An agency may not knowingly provide or refer a heath care practitioner to render temporary services who is not authorized under Health Occupations Article, Annotated Code of Maryland, to practice their profession in Maryland. B. An agency and client facility shall ensure that the scope of practice of the referred health care practitioner is consistent with Health Occupations Article, Annotated Code of Maryland. C. If an agency is aware of an action or inaction by a health care practitioner who is provided or referred by the agency that may be grounds for action under Health Occupations Article, Annotated Code of Maryland, the agency shall report the action or condition to the appropriate Board and the Office immediately when the action or condition is known by the agency. D. An individual shall have immunity from liability described in the Courts and Judicial Proceedings Article, §5-709, Annotated Code of Maryland, for making a report as required under §C of this regulation. E. Personnel Qualifications and Duties. (1) The agency shall maintain the following from client facilities: (a) Job descriptions for referred individuals; and (b) A documented procedure for the agency and client facility to determine that an individual's qualifications are consistent with the assignments to which the individual is being referred. (2) The agency shall maintain documentation indicating that individuals providing services in any health care facility within the State have been educated by the agency or the facility about: (a) The facility's policies and procedures related to the individuals' scope of practice and responsibilities in the referred assignment; and (b) The individuals' obligations under Maryland law to report abuse and neglect. (3) An agency shall attest on a form developed by the Department that the agency is in compliance with the federal: (a) Civil Rights Act of 1964; (b) Rehabilitation Act of 1973; (c) Americans with Disabilities Act of 1990; and (d) Drug Free Workplace Act of 1988, if applicable. #### Regulation .10 Civil Money Penalties — Imposition. *COMAR 10.07.03.10* A. The Department may impose a civil money penalty if a deficiency exists. B. In determining whether a civil money penalty is to be imposed, the Department shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The extent to which the deficiencies are part of a pattern; (3) The degree of risk to the health, life, or safety of the residents of the client facility caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of the agency to correct the deficiency or deficiencies; (5) An agency's prior history of compliance in general and specifically with reference to the cited deficiencies; and (6) Other factors as justice may require. C. If the Department determines that a deficiency or a pattern of deficiencies exists, the Department shall notify the agency of the deficiency or deficiencies and may: (1) Impose a per-day civil money penalty until compliance has been achieved; (2) Permit the agency the opportunity to correct the deficiencies by a specific date; or (3) Impose a per-instance civil money penalty for each deficiency. D. If the Department permits an agency the opportunity to correct the deficiencies by a specific date and the agency fails to comply with this requirement, the Department may impose a per-day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and compliance has been maintained. E. When a civil money penalty is imposed, the Department shall issue an order that includes the: (1) Deficiency or deficiencies on which the order was based; and (2) Amount of civil money penalty to be imposed. #### Regulation .11 Civil Money Penalties — Amount of Penalty. *COMAR 10.07.03.11* A. A civil money penalty imposed under this chapter for a first offense may not exceed: (1) $2,500 for each instance of violation; or (2) $2,500 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. B. A civil money penalty imposed under this chapter for a second offense may not exceed: (1) $5,000 for each instance of violation; or (2) $5,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. C. A civil money penalty imposed under this chapter for a third or subsequent offense may not exceed: (1) $10,000 for each instance of violation; or (2) $10,000 per day until correction of the deficiency or deficiencies has been verified and compliance has been maintained. #### Regulation .12 Civil Money Penalties — Effective Date and Duration of Penalty. *COMAR 10.07.03.12* A. Per-Instance Civil Money Penalty. The effective date may be as early as the date that the deficiency or deficiencies on which the civil money penalty is based first occurred. B. Per-Day Civil Money Penalty. (1) The daily civil money penalty starts to accrue as of the date of the inspection, survey, or interview by the Department that identifies the deficiency or deficiencies on which the civil money penalty is based. (2) The accrual of the daily civil money penalty ceases when correction of the deficiency or deficiencies on which the civil money penalty was based has been verified. #### Regulation .13 Civil Money Penalties — Payment of Penalty/Establishment of Escrow Account. *COMAR 10.07.03.13* A. A civil money penalty payment is due 15 calendar days after: (1) The time period for requesting a hearing has expired, if a request for a hearing has not been received; or (2) Receipt of a written request from the agency to waive its right to a hearing and reduce the amount of the civil money penalty by 40 percent, if the written request is received by the Department within 30 calendar days of the Department's order imposing the civil money penalty. B. The amount of the civil money penalty, when determined, may be deducted from any sum owed by the State to the agency. #### Regulation .14 Civil Money Penalties — Hearings. *COMAR 10.07.03.14* A licensee aggrieved by the imposition of a civil money penalty may appeal the action by filing a request for a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. #### Regulation .15 Emergency Suspensions. *COMAR 10.07.03.15* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action pursuant to State Government Article, §10-226(c), Annotated Code of Maryland. B. The Department shall deliver a written notice to the agency: (1) Informing the agency of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that form the basis for the emergency suspension; and (3) Notifying the agency of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. Suspended License. If a license is suspended by emergency action, the agency shall: (1) Immediately return the license to the Department; and (2) Cease making referrals. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter. F. The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .17 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. G. If the Secretary's final decision does not uphold the emergency suspension, the agency may resume operation. #### Regulation .16 Denial or Revocation of License. *COMAR 10.07.03.16* A. Denial or Revocation of License. The Secretary, for cause shown, may notify the agency of the decision to revoke or deny the license. Except as provided in Regulation .15 of this chapter, the denial or revocation shall be stayed if a hearing is requested. B. Criteria for Denial or Revocation. The Department shall notify the agency in writing of the following: (1) The effective date of the denial or revocation; (2) The reason for the denial or revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the denial or revocation; (4) That the agency is entitled to a hearing if requested, and to be represented by counsel; (5) That the agency shall stop providing services on the effective date of the denial or revocation if the agency does not request a hearing; (6) That the denial or revocation shall be stayed if a hearing is requested; and (7) That the agency is required to surrender its license to the Department if the denial or revocation is upheld. C. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .17 of this chapter. #### Regulation .17 Hearings. *COMAR 10.07.03.17* A. An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 calendar days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. ### Chapter 04 — Residential Treatment Centers for Emotionally Disturbed Children and Adolescents **Authority:** Health-General Article, §§19-301, 19-305, 19-308, 19-309, 19-320, 19-323, and 19-360, Annotated Code of Maryland **Administrative History:** Effective date: April 17, 1967 **Administrative History:** Amended effective March 27, 1973 **Administrative History:** Amended effective March 22, 1974 **Administrative History:** Regulation .02C amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .03 amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .03A amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .11B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Chapter revised effective May 22, 2017 (44:10 Md. R. 472) **Administrative History:** Regulation .02B amended effective June 8, 2026 (53:11 Md. R. 484) **Administrative History:** Regulation .04A, D amended effective June 8, 2026 (53:11 Md. R. 484) **Administrative History:** Regulation .17B amended effective June 8, 2026 (53:11 Md. R. 484) **Administrative History:** Annotation: COMAR 10.07.04 cited in Attorney General Opinion No. 82-034 (November 18, 1982) #### Regulation .01 Scope. *COMAR 10.07.04.01* A. The treatment and care of emotionally disturbed children and adolescents are of great concern to various State agencies including the Maryland Department of Health, Department of Human Services, Maryland State Department of Education and Department of Juvenile Justice. B. The Maryland Department of Health, Department of Human Services, Maryland State Department of Education, and Department of Juvenile Services, by statute, are responsible to ascertain that applicants for licenses conform to the regulations promulgated under the legal authority vested in the respective departments. #### Regulation .02 Definitions. *COMAR 10.07.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accreditation organization” means a private entity that conducts inspections and surveys of health care facilities based on nationally recognized and developed standards. (2) “Accredited residential treatment center” means a residential treatment center that is accredited by: (a) The Joint Commission on Accreditation of Healthcare Organizations; (b) The Commission on Accreditation of Rehabilitation Facilities; or (c) The Council on Accreditation. (3) “Adverse event” means an unexpected occurrence that: (a) Is related to a resident’s medical or behavioral treatment; and (b) Is not related to the natural course of the resident’s illness or underlying disease condition. (4) “Center” means a residential treatment center. (5) “Change in condition” means a significant change in a resident’s physical, mental, or psychological status including: (a) Life-threatening conditions; (b) Clinical complications, including significant somatic symptoms that require the assessment or treatment by qualified medical personnel; (c) The need to discontinue a medication or treatment because of: (i) An adverse consequence; or (ii) The need to begin a new form of treatment; (d) Evaluation at or admission to a hospital; (e) Injuries that require the assessment of or treatment by qualified medical personnel; (f) The use of restraint or seclusion; and (g) Suicide attempts. (6) “Department” means the Maryland Department of Health. (7) “Fire authorities” means the official fire safety agency including the State Fire Marshal and local fire departments or fire marshals as appropriate. (8) “Governing body” means the organizational structure that is responsible for all center operations, including: (a) Establishing policy; (b) Maintaining quality care; and (c) Providing management and planning for the center. (9) “Joint Commission” means the voluntary national healthcare accreditation service recognized for: (a) Medicare certification purposes by Public Law 89-97; and (b) Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland. (10) “Licensee” means the individual, partnership, association, or corporation to which a license is issued. (11) “Nonaccredited residential treatment center” means a residential treatment center that is not accredited by: (a) The Joint Commission on Accreditation of Healthcare Organizations; (b) The Commission on Accreditation of Rehabilitation Facilities; or (c) The Council on Accreditation. (12) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (13) “Resident” means any child or adolescent domiciled in a center for the purpose of receiving the services offered by a residential treatment center. (14) “Residential treatment center” means a psychiatric institution that provides campus-based intensive and extensive evaluation and treatment of children and adolescents with severe and chronic emotional disturbances who require a self-contained therapeutic, educational, and recreational program in a residential setting. (15) “Secretary" means the Secretary of Health. #### Regulation .03 License Requirements. *COMAR 10.07.04.03* A. License Required. A person may not establish, conduct, maintain, or operate in the State a center without first obtaining a license from the Secretary. B. Separate License Required. Centers maintained on separate premises shall obtain separate licenses, even though operated under the same management. C. License Not Required Under This Chapter. The following facilities are not deemed to be within the purview of these licensing requirements and are not required to obtain a license under these provisions: (1) Any institution for well children, including day nurseries, child care centers, foster boarding homes, and institutions for intellectually disabled children; and (2) Institutions operated by the Federal Government. D. Posting of License. The license shall be posted conspicuously on the premises. E. Other Licensing Requirements. Before issuing a license the Secretary shall receive written notification that the center meets the following requirements: (1) Clinical services and treatment program shall be approved by the Department; (2) Child care services and program shall be approved by the Department of Human Services in accordance with its published regulations; (3) The educational program shall be approved by the State Department of Education. F. Licensed Capacity. A center may not admit residents in excess of the number authorized and shown on the current license. #### Regulation .04 Licensing Procedure. *COMAR 10.07.04.04* A. Application. Applicants shall conform to the following: (1) An applicant desiring to open or to continue the operation of an existing center shall file with the Secretary, on a written or electronic form provided by the Secretary: (a) The name of the applicant desiring the license; and (b) The location of the center, the name of the person in charge, and any additional documents and information that the Secretary may require. (2) Application on behalf of a corporation or association or a governmental unit or agency shall be made by two of its officers, and the names of their board members shall be submitted. (3) All licenses shall expire 3 years from the date of issuance unless revoked. (4) The applicant for an original license shall submit the following, and insure that current copies are on file with the Department: (a) Written permission from local zoning authority for an original license in municipalities which have established zoning; (b) Written approval from the appropriate fire authorities; (c) A current food service permit; and (d) Copy of signed agreement between the center and the principal somatic physician and psychiatrist. (5) Renewal. Application for the renewal of the license shall be made each year at least 30 days before expiration of issued license, submitted on written or electronic forms provided by the Secretary. (6) License renewal shall be based on accreditation by the Joint Commission, the Commission on Accreditation of Rehabilitation Facilities, or the Council on Accreditation. (7) The center shall be required to submit evidence of current accreditation that shall include: (a) A copy of the current accreditation letter issued to the center; (b) A copy of the standards determined not to be in compliance, or with recommendations for improvement issued to the center; and (c) The evidence of the action taken to correct noncompliance which was submitted to the accreditation organization. B. Restrictions. (1) Centers licensed under these regulations may not use in their title words “Hospital”, “Sanitarium”, “Nursing”, “Convalescent”, or “Rest”. (2) A license shall be valid only in the hands of the licensee to whom it is issued and may not be subject to sale, assignment, or other transfer, voluntary or involuntary, nor may a license be valid for any premises other than those for which originally issued. C. Duration of License. Licenses are valid for 1 year from the date of issuance unless revoked. D. Licenses for Less Than 12 Months for the Operation of Hospitals and Related Institutions. The Secretary may issue a provisional license to a nonaccredited residential treatment center if: (1) The nonaccredited residential treatment center is pending accreditation by The Joint Commission, the Commission on Accreditation of Rehabilitation Facilities, or the Council on Accreditation; and (2) The provision license is valid for a period not to exceed 12 months. #### Regulation .05 Denial or Revocation of License. *COMAR 10.07.04.05* A. The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home. B. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home. C. The Secretary may deny or revoke a license if the center does not meet the requirements of: (1) Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (2) Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, including this chapter. D. A center subject to denial or revocation of license under this chapter, may request a hearing as set forth in accordance with Regulation .20 of this chapter. #### Regulation .06 Inspection. *COMAR 10.07.04.06* Open to Inspection. A center licensed under this chapter and any premises proposed to be operated by an applicant for a license shall be open at all reasonable times to inspection by: A. The Secretary or designee; B. The Department of Human Services; C. The Maryland State Department of Education; D. The Department of Juvenile Services; or E. Any other agency authorized by the Secretary. #### Regulation .07 New Construction or Alteration. *COMAR 10.07.04.07* A. Submission of Plans. Plans shall be submitted to the Secretary before construction or alterations begin affecting its functional structure or normal bed capacity. These plans shall have the prior approval of local zoning authorities and the appropriate fire authorities. The Secretary shall review promptly the plans and shall notify the applicant or licensee within 30 days that the building, alteration, additions, or changes, are approved or disapproved with the recommendations that the Secretary may make. If an application is disapproved, the applicant or licensee shall be informed of the reasons at the time of notification. B. Application to Service Facilities. A system of water supply, plumbing, sewerage, electrical power, garbage or refuse disposal may not be installed or extended until complete plans and specifications have been submitted and approved in accordance with §A, of this regulation. #### Regulation .08 Physical Plant. *COMAR 10.07.04.08* A. Construction. A new building designated as a residential treatment center and any existing building proposed for conversion for this use shall meet the following: (1) The construction of the building shall prevent the entrance and harborage of rats and other rodents; (2) The center shall comply with all other applicable governing laws or ordinances; and (3) The center shall be constructed to comply with the requirements of the Americans with Disabilities Act. B. Heating. A center shall be equipped with a central heating system capable of maintaining a minimum temperature of 68°F throughout the residential section of the building when the temperature falls to 0°F or below. Alternate modern types of heating systems may be accepted if approved by the fire authorities. Space heaters and portable heaters are not acceptable. C. Lighting. (1) Lighting shall be adequate for the activities conducted in the various areas. (2) Bedrooms and dormitories shall be lighted by outside windows and shall also have artificial light adequate for reading and other uses. (3) All entrances, hallways, stairways, inclines, ramps, cellars, attics, storerooms, kitchens, laundries, and service units shall have sufficient artificial lighting to prevent accidents and promote efficiency of service. D. Bathrooms. A center shall provide the following minimum bathroom facilities: (1) One hand sink and one toilet for each six residents of the same sex on each floor; (2) One bathtub or shower for each 12 beds on each floor; (3) The number of beds for which the center is licensed shall be used in determining the number of bathroom fixtures required even if some of the beds are not occupied; (4) There shall be one complete bathroom on each floor used by the residents, regardless of the number of beds; (5) All bath and toilet rooms shall be easily accessible, conveniently located and well lighted with a night light burning all night and have mechanical exhaust ventilation; (6) A lavatory or toilet facility may not: (a) Open directly into a kitchen, pantry or food preparation room; or (b) Be located so that a resident is required to pass through another resident's room to enter it; and (7) Bathrooms shall be constructed using anti-ligature fixtures and designed for the safety of the residents. E. Plumbing. (1) All plumbing within the building shall be installed in conformance with existing building and sanitary regulations. (2) All sewage disposal shall be in accordance with existing regulations. F. Water Supply. (1) Centers shall be served by water from a safe public water supply, if available, as determined by the Department. If a safe public water supply is not available, a private water supply approved by the Department may be used. (2) Adequacy. The supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve fixtures in the center. (3) Temperature. The hot water heating equipment shall be of sufficient capacity to supply an adequate amount of water not in excess of 125°F for bathing and showering. The center shall install mixing valves or other anti-scalding devices. (4) Hot water for kitchen and laundry use shall be at least 160°F. G. Seclusion and Restraint. (1) Seclusion and restraint rooms shall be constructed and maintained free of hazards to ensure the safety of the residents. (2) The rooms shall allow for the unobstructed view of the resident. (3) The rooms shall be equipped with adequate lighting for the staff to view the resident. (4) Locking mechanisms on doors shall allow for prompt access in the event of an emergency. (5) The rooms shall be adequate in size for staff to safely restrain residents or provide emergency care and treatment. #### Regulation .09 Fire Regulations. *COMAR 10.07.04.09* A center shall be free from fire hazards and shall comply with all applicable local fire and building codes and the safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06. #### Regulation .10 General Requirements. *COMAR 10.07.04.10* A. Cleanliness and Maintenance. The following shall be observed: (1) The building and all its parts and facilities shall be kept in good repair, neat, and attractive. The safety and comfort of the residents shall be the first consideration. (2) All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be easily cleanable. (3) Adequate storage space shall be provided for excess supplies, personal possessions of residents and staff, linens, and similar items. This storage space may not constitute a fire or accident hazard, and may not be in the way of residents or staff. All supplies shall be stored 10 inches off the floor and away from the wall to allow for cleaning and pest control. (4) The grounds shall be kept clean, neat, reasonably attractive, and free of hazards. (5) The center shall be maintained free from insects and rodents. (6) Bathtubs and hand sinks may not be used for laundering or storing soiled linens. (7) Bathtubs and shower stalls may not be used for storage. B. The center shall provide adequate furnishings and equipment to meet the needs of the residents, including but not limited to: (1) Beds and mattresses in good repair; (2) A storage area for each resident within their room; (3) A desk and chair for each resident room; and (4) Adequate furnishings in dayrooms and lounge areas to allow for recreational and relaxation purposes. #### Regulation .11 Food Services. *COMAR 10.07.04.11* A. Dietary Requirements. The following minimum requirements shall be observed: (1) A minimum of three meals in each 24 hour period shall be served. In addition, nutritious between meal and bedtime snacks should be offered to all residents no less than 1-1/2 to 2 hours before the next meal. (2) There may not be an interval longer than 12 hours from the evening meal or substantial bedtime snack to breakfast. The diet shall consist of simply prepared, appropriately served, palatable foods including a minimum of the following daily: (b) Meat, fish, poultry, eggs: Two servings per day; (c) Vegetables and fruits: Four servings per day, including one serving of citrus fruit or tomato daily and one serving of a dark green or deep yellow vegetable or fruit five times weekly; (d) Breads and Cereals: Four servings daily. (3) Size of servings and consistency or texture of food will be regulated by the age and condition of the residents. (4) A record of the current week's menu plan shall be posted and kept on file for the following 2 weeks. A time schedule for service of meals to residents and personnel should be established and it is recommenced that meals be served approximately 4 hours apart for breakfast, lunch and dinner. (5) Special diets or any variation of these requirements ordered by the resident's physician shall be provided for residents as ordered. (6) Meals shall be served in a dining or community room equipped with furniture and utensils appropriate to the age and development of the residents. A resident with a temporary illness shall be served privately. B. Sanitation and Personal Hygiene. All applicable requirements of COMAR 10.15.03 shall be observed. #### Regulation .12 Management Requirements. *COMAR 10.07.04.12* A. Responsibility. The licensee is responsible for conformance with licensing regulations. B. Responsible Person. The licensee or administrator appointed by the licensee and all persons in supervisory or other responsible positions shall be 21 years old or older. The licensee shall ensure 24-hour coverage by an administrator or designee. C. Qualifications of Administrator. (1) The administrator of the center shall be a psychiatrist, psychologist, social worker, registered nurse, or any other person trained in the behavioral sciences or in administration. (2) The administrator shall be capable by experience and training of directing and supervising persons working in the center. D. Financial Responsibility. The licensee shall provide to the Secretary assurance of financial responsibility to meet the minimum needs for services offered, safety, maintenance, food, and comfort of the residents of the center. E. Compliance with Regulations. (1) The licensee shall charge the administrator to be familiar with this chapter. (2) The licensee or administrator shall also familiarize employees with those standards related to their work. (3) The center’s governing body shall be responsible for the center’s compliance with all applicable federal and State regulations. F. Availability of Information. The licensee or administrator shall make available to the Secretary such information as may be requested to ensure that the institution is meeting requirements of this chapter. #### Regulation .13 Health Services. *COMAR 10.07.04.13* A. Supervision of Treatment Program. Treatment at any center shall be under the direction of a qualified psychiatrist who is responsible for the adequacy, quality, and appropriateness of the treatment program for each resident. There shall be sufficient professional personnel to ensure the implementation of the treatment program for each resident. B. Medical Supervision. A resident shall be under the medical care of a physician licensed in the State. Each resident shall have a complete physical examination done within 30 days before admission, and updated within 72 hours after admission, and at appropriate, regularly scheduled intervals thereafter. C. Principal Physician. The center shall arrange for a physician to serve as principal physician and a qualified relief to cover periods when their services are not available. The medical director or assigned on call physician shall respond at times of emergency and be available as needed to advise the administrator and nursing staff on medical questions. D. Restrictions on Medication. Medication may not be given without the written order of a physician, nurse practitioner, or physician assistant except in an emergency when medication or treatment may be given on the verbal or telephone order of the prescriber. These orders shall be entered on the doctor's order sheet and shall be confirmed by the prescriber at the next visit. E. Medication Handling. The center shall comply with all applicable Federal, State, and local laws and ordinances, standards, and codes regulating the purchasing, handling, storage, administration, and recording of medications, including controlled substances. #### Regulation .14 Staffing Requirements. *COMAR 10.07.04.14* A. The administrator shall employ sufficient and qualified personnel to ensure adequate treatment and care of the residents and the maintenance, cleaning, and housekeeping. B. The staff shall be sufficient in number so that the individual needs of residents are met. C. Provision shall be made for relief personnel during vacations or other relief periods. The relief personnel shall have qualifications equivalent to those of the person being relieved. D. Clinical staff shall, at a minimum, have current training in: (1) CPR; (2) The Heimlich maneuver; and (3) First aid. E. The center shall ensure that one or more competent trained individuals are present 24 hours a day with the required skills to address medical and behavioral emergencies. F. The center shall maintain personnel records on each employee, including: (1) The initial application; (2) Current professional license and certification; (3) Criminal background checks; and (4) Performance appraisals and annual competency evaluations. G. Each staff member shall have a pre-employment examination for tuberculosis and additional testing when known TB exposure occurs. H. There shall be personnel policies which define staff jobs, qualifications, hours, vacation, sick leave, and retirement. #### Regulation .15 Accommodations. *COMAR 10.07.04.15* A. Usable Living Space Needed. (1) Each center shall provide at least 35 square feet of usable floor space per resident, in addition to bedroom space, in order to meet minimal requirements for dining, living, and recreational facilities. (2) A minimum of 80 square feet is required for single occupancy bedrooms, and 60 square feet per bed for multiple occupancy bedrooms. (3) Usable space excludes service areas, entrance ways, door swing areas, closets, dormers, and other breaks in floor areas. B. Closet Space. Adequate closet space, conveniently located, shall be provided to allow each resident to keep necessary items of clothing and other personal belongings. C. Areas Devoted to Educational Programs. Provision of space for classrooms and other educational activities shall be made in accordance with the needs of the center as approved by the Department of Education. #### Regulation .16 Restraints and Seclusion. *COMAR 10.07.04.16* The use of restraints and seclusion shall be in compliance with 42 CFR §§483.352—483.376 Condition of Participation for the Use of Seclusion and Restraint in Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services For Individuals Under Age 21. #### Regulation .17 Complaint Investigations. *COMAR 10.07.04.17* A. Notwithstanding any other provision of this chapter, residential treatment centers shall be open to inspections by the Department to investigate and resolve any complaint concerning: (1) Resident care; (2) Safety; (3) Medical and nursing supervision; (4) Physical environment; (5) Sanitation; or (6) Dietary matters. B. Complaints. (1) To expeditiously resolve a complaint that alleges the existence of any non-life-threatening deficiency, the Department may refer the complaint directly to the residential treatment center. (2) If appropriate, issues relating to the practice of medicine or the licensure or conduct of a health professional may be referred to the residential treatment center and to the appropriate health occupation licensing board for resolution. (3) If the Department determines that the center has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a potentially serious or life-threatening deficiency, the Department shall conduct an independent investigation. (4) When conducting its independent investigation of an accredited residential treatment center, the Department shall use the standards of the accreditation organization that accredits the residential treatment center and this chapter. #### Regulation .18 Reports. *COMAR 10.07.04.18* A. The center shall furnish to the Secretary reports covering the following: (1) Deaths, serious injuries, or unusual incidents, including suicide attempts, by no later than the close of business of the next business day following the event; and (2) Any occurrences which threaten the welfare, safety, or health of any resident of the center such as fire, infectious disease outbreaks, or poisoning. B. The center shall comply with the reporting requirements of the Department of Juvenile Services, the Department of Human Services, the Maryland State Department of Education, or other placement agencies. C. The center shall comply with the reporting requirements of 42 CFR §483.374(b) and (c). D. Serious Occurrence Notification. (1) Staff shall report any serious occurrence described in 42 CFR §483.374(b) involving a resident to both the State Medicaid agency and the State-designated Protection and Advocacy System by not later than close of business the next business day after a serious occurrence. (2) The report shall include: (a) The name of the resident involved in the serious occurrence; and (b) A description of the occurrence. (3) In the case of a minor, the center shall notify the resident’s parent or parents or legal guardian or legal guardians: (a) As soon as possible; or (b) No later than 24 hours after the serious occurrence. (4) Staff shall document in the resident’s record that the serious occurrence was reported to both the State Medicaid agency and the State-designated Protection and Advocacy System, including the name of the individual to whom the incident was reported. (5) A copy of the report shall be maintained in the resident’s record, as well as in the incident and accident report logs kept by the center. #### Regulation .19 Civil Money Penalties. *COMAR 10.07.04.19* A. Civil Money Penalties. The Secretary may impose a civil money penalty on a person if: (1) The person maintains or operates an unlicensed center; or (2) A serious or life-threatening patient care deficiency exists and the center fails to correct the deficiency through immediate corrective action. B. In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors: (1) Number, nature, and seriousness of the patient care deficiencies; (2) The extent to which the patient care deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the residents of the center that is caused by the patient care deficiency or deficiencies; (4) The efforts made by, and the ability of the center to correct, the patient care deficiency or deficiencies through implementation of immediate corrective action; and (5) The center’s prior history of compliance. C. If the Department determines that a person has been operating an unlicensed center, the Department may impose a civil money penalty not to exceed $10,000. D. If the Department determines that a serious or life-threatening deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the center of the deficiency or deficiencies and may: (1) Impose a per-day civil money penalty not to exceed $10,000 until sustained compliance has been achieved; (2) Permit the center the opportunity to correct the deficiencies by a specific date; or (3) Impose a per-instance civil money penalty not to exceed $10,000 for each instance of violation. E. If the Department permits a center the opportunity to correct the deficiencies by a specific date, and the center fails to comply with this requirement, the Department may impose a per-day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. F. If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the: (1) Deficiency or deficiencies on which the order is based; (2) Amount of civil money penalties to be imposed; and (3) Manner in which the amount of civil money penalties imposed was calculated. G. A center subject to a civil money penalty under this regulation may request a hearing as set forth in accordance with Regulation .20 of this chapter. #### Regulation .20 Hearings. *COMAR 10.07.04.20* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. This request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as provided in COMAR 10.01.03.16. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.18. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.20. #### Regulation .21 Notifications. *COMAR 10.07.04.21* A. Within 24 hours of an event or change in condition and in accordance with State and federal confidentiality laws, a center shall attempt to notify a resident and a resident’s representative, family member, legal guardian, or custodian of: (1) A change in the resident’s condition; (2) An adverse event that affected the resident; and (3) If appropriate, the corrective action taken. B. The notification may be waived by the individual identified under Regulation .19A of this chapter if the individual sends a written response instructing the center that the individual: (1) Waives the required notifications; or (2) Requests that the notification be provided only under the circumstances identified in the written response. C. All written responses waiving some or all notifications shall be maintained in the resident’s medical record. D. The center shall document in the medical records that the required notification were completed. The documentation shall include: (1) The nature of the event or change in condition; (2) The names of the individuals who received notification; (3) The dates and times of the notifications; and (4) The name of the staff who made the notifications. E. If a center has made reasonable attempts to notify the required individuals and has been unable to make contact, the failure to reach the individuals shall be documented in the medical records. F. If the Department determines that the center has failed to provide the required notification, the Department shall require the center as part of its plan of correction to provide notification as soon as possible. #### Regulation .22 Resident Rights. *COMAR 10.07.04.22* A. The center shall post the list of resident rights in areas of the center where the residents can read the posting. A resident of a residential treatment center has the right to: (1) Be treated with respect; (2) Have their cultural spiritual, personal beliefs, values, and preferences respected; (3) Personal privacy; (4) Practice their religious beliefs; (5) Receive information about care and treatment in a manner that he or she understands; (6) Be free from neglect, exploitation, and verbal, sexual, physical, and mental abuse; (7) Access protection and advocacy services; (8) Receive care in a safe setting; (9) File a complaint and have it investigated without fear of retribution; (10) Have visitors in accordance with the center’s visitation policy; (11) Send and receive mail; (12) Consult with their attorney, advocate, or social worker in private; and (13) Make and receive telephone calls in accordance with the center’s policy. B. The resident’s parents or guardians or, if the resident is age 18 or older, the resident shall have the right to: (1) Be involved in the treatment planning process; (2) Consent to treatment and medication; (3) Be informed of changes in the treatment plan and medication regimen; (4) Withhold consent for treatment; and (5) Have complaints investigated in a timely manner. C. A resident’s rights shall only be restricted if the provision of that right poses a threat to the therapeutic needs of the resident or places the resident’s or other residents’ safety and security at risk. D. Restrictions on a resident’s rights shall be documented in the treatment plan and reviewed and approved by the treatment team. E. Restrictions on a resident’s rights shall be removed as soon as possible when the restriction is not therapeutically indicated. ### Chapter 05 — Residential Service Agencies **Authority:** Health-General Article, Title 19, Subtitle 4A, Annotated Code of Maryland **Administrative History:** Effective date: January 17, 1994 (21:1 Md. R. 33) **Administrative History:** Regulation .01B amended effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .02 amended effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .03C repealed effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .05-1 adopted effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulations .01—.08 repealed and new Regulations .01—.28 adopted effective May 1, 2012 (38:21 Md. R. 1277) **Administrative History:** Regulation .04A amended effective December 21, 2015 (42:25 Md. R. 1543); March 28, 2016 (43:6 Md. R. 406) **Administrative History:** Regulation .04A, I amended effective August 19, 2013 (40:16 Md. R. 1343); January 6, 2014 (40:26 Md. R. 2162); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .04H amended effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .04H, I amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .12E amended as an emergency provision effective June 1, 2012 (39:13 Md. R. 784); amended permanently effective September 3, 2012 (39:17 Md. R. 1148) #### Regulation .01 Purpose. *COMAR 10.07.05.01* The purpose of this chapter is to establish minimum standards for licensure of residential service agencies that conduct business in Maryland. #### Regulation .02 Definitions. *COMAR 10.07.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means normal daily activities including: (a) Eating or being fed; (b) Grooming, bathing, oral hygiene including brushing teeth, shaving, and combing hair; (c) Mobility, transferring, ambulation, and access to the outdoors, when appropriate; (d) Toileting; and (e) Dressing in clean, weather-appropriate clothing. (2) “Agency” means a residential service agency as defined in §B(25) of this regulation. (3) “Branch office” means a satellite office of a residential service agency that: (a) Is operated by the same person, corporation, or other business entity that manages the parent residential service agency; and (b) Along with the parent residential service agency has the same: (i) Ownership tax identification number as the parent residential service agency; (ii) Upper-level management; (iii) Policies and procedures; and (iv) Services within the same geographic area as the parent residential service agency. (4) “Certified care” means a service or services that: (a) May be performed for compensation only by an individual who is certified by the Board of Nursing, including a certified medication technician, a certified medicine aide, or a certified nursing assistant; and (b) Include nursing functions that are routinely delegated by a registered nurse. (5) “Certified medication technician” means an individual who: (a) Has completed a Board-approved medication technician training program; and (b) Is certified by the Board as a medication technician. (6) “Certified medicine aide” means an individual who is: (a) A certified nursing assistant who has completed a Board-approved course in medication administration; and (b) Certified by the Board as a certified medicine aide. (7) “Certified nursing assistant” means an individual, regardless of title, who: (a) Routinely performs for compensation delegated nursing tasks which were delegated by a registered nurse or licensed practical nurse; and (b) Is certified by the Maryland Board of Nursing as a certified nursing assistant. (8) “Client representative” means an individual with legal authority to make decisions on behalf of the client as set forth in Regulation .13 of this chapter. (9) “Clinical record” means a written account of all services provided to a client by the agency as well as all pertinent medical information necessary to provide care. (10) “Department” means the Maryland Department of Health. (11) “Governing authority” means the individual, partnership, agency, group, corporation, or other entity that is designated to assume full responsibility for the policy determination, management, operation, and financial liability of the agency. (12) “Home health care” includes any of the following services: (a) Audiology and speech pathology; (b) Dietary and nutritional services; (c) Drug services; (d) Home health aide; (e) Laboratory; (f) Medical social services; (g) Nursing; (h) Occupational therapy; (i) Physical therapy; (j) Provision of invasive medical equipment; and (k) Home medical equipment services. (13) “Home medical equipment services” means the delivery, installation, maintenance, or replacement of, or instruction in the use of, medical equipment used by a sick or disabled individual to allow the individual to be maintained in a noninstitutional environment. (14) “Household or family support services” means performance of tasks necessary to supplement an individual’s ability to perform: (a) Child care for children who require no medical attention; or (b) Instrumental activities of daily living. (15) “Informal dispute resolution conference (IDR)” means an informal meeting that provides a licensee the opportunity to question the Department about deficiencies cited on a recent inspection. (16) “Informed consent” means the willing, uncoerced acceptance of medical intervention by a client or a client representative with legal authority to make health care decisions after adequate disclosure of the nature of the intervention, and its risks and benefits, as well as alternatives with their risks and benefits. (17) “Instrumental activities of daily living” means: (a) Light housekeeping and home management; (b) Meal planning and preparation; or (c) Shopping and errands. (18) “Intravenous therapy” means the provision of services and monitoring and instruction related to substances that are administered intravenously, including but not limited to: (a) Total parenteral nutrition (TPN); (b) Hydration therapy; (c) Chemotherapy; (d) Antibiotic therapy; and (e) Blood and blood products. (19) “Invasive medical equipment” means a device that invades tissue or a body cavity for the purpose of maintaining treatment modalities, including but not limited to: (a) Intravenous lines, whether enteral or parenteral; (b) Catheters; (c) Ventilators; (d) Gastric or nasogastric tubes; (e) Tracheostomy; and (f) Ostomies. (20) “Law enforcement agencies” mean the Maryland State Police or a police agency of a county or municipal corporation. (21) “License” means a document issued by the Secretary to a person to operate a residential service agency in this State. (22) “Medical equipment” means technologically sophisticated medical devices including but not limited to: (a) Oxygen and oxygen delivery systems; (b) Ventilators; (c) Respiratory disease management devices; (d) Electronic and computer-driven wheelchairs and seating systems; (e) Apnea monitors; (f) Transcutaneous electrical nerve stimulator (T.E.N.S.) units; (g) Low air loss cutaneous pressure management devices; (h) Sequential compression devices; (i) Neonatal home phototherapy devices; (j) Feeding pumps; and (k) Electrically powered hospital beds. (23) “Personal care provider under the Medical Assistance Personal Care Program” means an individual or personal care agency that has been approved by the Department as meeting requirements set forth in COMAR 10.09.20 and 10.09.36 to provide personal care services to individuals who are certified for and receiving Medical Assistance benefits. (24) “Plan of correction” means a written response from the residential service agency that addresses each deficiency cited as a result of an inspection by the Department. (25) Residential Service Agency. (a) “Residential service agency” means: (i) An individual, partnership, firm, association, corporation, or other entity of any kind that is engaged in a nongovernmental business of employing or contracting with individuals to provide at least one home health care service for compensation to an unrelated sick or disabled individual in the residence of that individual; or (ii) An agency that employs or contracts with individuals directly for hire as home health care providers. (b) “Residential service agency” does not include: (i) A home health agency that is licensed under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; (ii) An individual, partnership, firm, association, corporation, or other entity of any kind that is required to be licensed as a home health agency under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; (iii) A home-based hospice care program that is licensed under Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland; (iv) A hospital that is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; (v) A related institution that is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; (vi) A nursing referral service agency that is licensed under Health-General Article, Title 19, Subtitle 4B, Annotated Code of Maryland, that screens or refers individuals for a client’s selection or rejection as its sole business operation, and does not itself provide any home health care service; (vii) A personal care provider under the Medical Assistance Personal Care Program; (viii) An individual practicing in a health occupation for which the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland; (ix) A business entity consisting of a group of individuals licensed under the same title of Health Occupations Article, Annotated Code of Maryland, which provides only that same, single, licensed health care service to its clients; or (x) A residential rehabilitation services provider approved under regulations adopted under Health-General Article, §10-901, Annotated Code of Maryland. (26) “Secretary” means the Secretary of Health. (27) Significant Change of Condition. (a) “Significant change of condition” means a change in a client’s health, functional, or psychosocial condition that causes either an improvement or a deterioration in a client’s condition. (b) “Significant change of condition” does not include any ordinary, day-to-day fluctuations in health status, function, or behavior or an acute short-term illness, such as a cold, unless these fluctuations continue to reoccur. (28) “Skilled care” means a service or services that may be provided only by an individual who: (a) Is licensed under Health Occupations Article, Annotated Code of Maryland; and (b) Exercises specialized knowledge, judgment, and skill. (29) “Skilled services” means services provided by or under the supervision of a registered nurse and in accordance with the plan of treatment. (30) “Waiver of services” means an informed agreement by a competent adult client to receive certified care or skilled services that are less than the level of care that is recommended by the licensee or a representative of the licensee. #### Regulation .03 License Required. *COMAR 10.07.05.03* A. A person, partnership, corporation, association, or other entity may not conduct or operate an agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter. B. An agency that provides only household or family support services as defined in Regulation .02B(14) of this chapter does not require licensure. C. Separate License Required. (1) Except as provided in §C(2) of this regulation, a separate license is required for each agency. (2) A branch office may operate under the same license of the agency. D. Posting of a License. The licensee shall display the agency’s current license in a conspicuous place, at or near the entrance of the agency’s office. E. This chapter does not preclude an agency from operating with independent contractors. #### Regulation .04 Licensing Procedures. *COMAR 10.07.05.04* A. Application for License. (1) To obtain and maintain a license, an applicant shall meet all of the requirements of: (a) This chapter; and (b) Other applicable federal, State, and local laws and regulations. (2) An applicant shall submit: (a) An application on a written or electronic form developed by the Department; (b) Verification that the applicant or corporate representative is 21 years old or older; (c) Documentation of any prior denial, suspension, or revocation of a license or certification to provide care to third parties; (d) Identification of any individual or corporate owner of a 25 percent or more interest in the agency; (e) Ownership information as specified on an addendum to the application; (f) Information concerning any license or certification held by the applicant under Health Occupations Article or Health-General Article, Annotated Code of Maryland, including prior or current operation of a similar health care program by the applicant; (g) Disclosure of any criminal charges or convictions, and disclosure of any findings of violation of: (i) Medicare and Medicaid laws and regulations; (ii) Health-General Article, Annotated Code of Maryland; or (iii) Health Occupations Article, Annotated Code of Maryland; (h) Information demonstrating the financial or administrative ability to operate an agency in compliance with this chapter, which shall include at a minimum a business plan that contains a: (i) 1-year operating budget; (ii) Marketing plan that identifies the populations to be served; and (iii) Detailed and specific description of agency services; (i) Copies of the agency’s policies and procedures as specified in Regulation .08B of this chapter; (j) Proof of Workers’ Compensation for all employees as required by the Maryland Workers’ Compensation Commission; and (k) A nonrefundable license fee of $1,000 made payable to the Department for a 3-year licensing fee. B. Additional Requirements for Initial Licensure. (1) If the applicant, owner, or person identified in §A(2)(d) of this regulation has had their license suspended or revoked by the Department that person may not own, operate, or manage another agency for 10 years without good cause shown. After 10 years, the applicant shall submit evidence to the Department that the applicant is capable of owning, managing, or operating an agency within the laws and regulations. (2) If an applicant, owner, or person identified in §A(2)(d) of this regulation operates or manages an agency, that applicant, owner, or individual may not apply to open additional agencies, if the agency: (a) Has had sanctions imposed within the last 2 years; and (b) Has not achieved compliance with the regulations at the time of application for licensure. (3) The Department reserves the right to deny licensure for a residential service agency to an applicant, an owner, or an individual identified in §A(2)(d) of this regulation, based on that person’s prior: (a) History of violations of residential service agency regulations; or (b) Criminal history that the Department determines may be potentially harmful to clients. C. The Department shall review all applications for licensure to determine whether the applicant: (1) Can provide appropriate services to sick or disabled individuals who require care in the individuals’ residence; and (2) Meets the regulatory requirements of this chapter. D. In addition to any other rights of inspection, before approving or denying an application for licensure, the Department may conduct an announced or unannounced on-site inspection of the agency. E. Based on information provided to the Department by the applicant, the Secretary shall: (1) Approve the application unconditionally; (2) Approve the application conditionally, which may include, among other conditions, requiring: (a) The applicant to use the services of a management firm approved by the Secretary; or (b) A licensure term of less than 1 year; or (3) Deny the application. F. The Secretary may not require the use of a management firm for a period in excess of 24 months. G. A person aggrieved by a decision of the Secretary under this regulation to deny a license application may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .28 of this chapter. H. Duration of License. A license is valid for 3 years from the date of issuance, unless: (1) Surrendered, suspended, or revoked; or (2) It is a provisional license as described in §J of this regulation. I. License Renewal. A licensee shall submit to the Department: (1) An application for license renewal on a written or electronic form developed by the Department; (2) A nonrefundable license renewal fee of $1,000 made payable to the Department for a 3-year licensing fee; (3) Copies of any policies and procedures that have changed substantively since they were previously reviewed by the Department, including those relevant to: (a) Handling of complaints made to the agency; and (b) Evaluation and assessment of clients; (4) Valid professional licenses and certificates for all current employees; and (5) An annual data collection survey in the form and manner prescribed by the Secretary with each application for license renewal. J. Licenses for Less than 1 Year. (1) The Department may issue a provisional license if: (a) The agency intends to provide services limited to skilled nursing and home health aid services; or (b) The residential service agency is not in full compliance with this chapter, but, in the opinion of the Department, the: (i) Noncompliance does not constitute a safety or health hazard; and (ii) Applicant or licensee has submitted a plan of correction that is acceptable to the Department which satisfactorily addresses the correction of each deficiency within a timeframe acceptable to the Department. (2) A provisional license may not be extended beyond its expiration date. K. If an agency fails to comply with the regulations of this chapter and the Department needs to conduct more than one on-site prelicensure visit, the Department may: (1) Charge $250 per additional on-site visit; or (2) Deny the license. #### Regulation .05 Changes in an Agency That Affect the Operating License. *COMAR 10.07.05.05* A. Change of Services or Name. (1) During the licensure period, a licensee may not: (a) Provide services for which it has not been approved to provide; or (b) Change the name under which the program is doing business without the Department’s approval. (2) When the licensee wants to provide additional services which require a license under this chapter, before offering the services, the licensee shall submit to the Department: (a) A new application and written request for a new license citing the additional services the agency wants to provide; (b) Policies and procedures pertaining to the additional services the agency wants to provide; and (c) An application fee as required by Health-General Article, §19-4A-03(c), Annotated Code of Maryland. (3) When there is a change in name or address of the licensee, but no change of ownership, an amended license is required and the licensee shall pay $50 for the issuance of an amended license. (4) Sale or Transfer of an Agency. (a) If a sale or transfer of an agency causes a change in the person or persons who control or operate the agency, the agency is considered a new agency and the licensee shall apply for a new license and conform to all regulations applicable at the time of the transfer of operations. (b) The transfer of any stock which results in a change of the person or persons who control the agency or the transfer of any stock in excess of 25 percent of the outstanding stock constitutes a sale. B. Voluntary Closure or Change of Residential Service Agency Ownership. (1) A licensee shall notify the Department in writing at least 45 days in advance of any intention to: (a) Voluntarily close; (b) Change ownership; or (c) Sell its agency. (2) The licensee shall include the following information in the notice to the Department: (a) The method for informing clients or client representatives, if applicable, of its intent to close, change ownership, or sell its agency; and (b) The actions the licensee will take to assist clients in securing comparable services and assistance, if necessary. (3) A licensee shall notify clients or client representatives, if applicable, of any proposed changes set forth in §B(1) of this regulation, in writing, at least 45 days before the effective date of the proposed change. (4) Whenever ownership of an agency is transferred from the person or organization named on the license to another person or organization, the future owner shall apply for a new license. The future owner shall file an application for a license at least 45 days before the transfer. (5) The Department shall issue a new license to a new owner who meets the requirements for licensure under this chapter. The former licensee shall return its license to the Department by certified mail. (6) A licensee named in the original license remains responsible for the operation of the agency until a new license is issued to the new owner. The current licensee remains responsible for correction of all outstanding deficiencies and impending sanctions until a new license is issued to the new owner. After a new license is issued, the new owner shall become responsible for correction of all outstanding deficiencies and impending sanctions. (7) In addition to the notice to the Department required by §B(1) and (2) of this regulation, after an agency closes, the licensee shall: (a) Notify the Department of the date of closure; and (b) Return all licenses, past and present, to the Department by certified mail. C. Changes to Licensure Information. A licensee shall immediately notify the Department of any change in the information the licensee had submitted with the most recent application. D. License — Sale, Assignment, or Transfer. The license is valid in the name of the licensee to whom it is issued, and is not subject to sale, assignment, or other transfer. E. If an agency fails to comply with §§A—D of this regulation, the Department may impose a fine of up to $500 for each violation.. F. A license is void if the agency ceases to operate. #### Regulation .05-1 Special Requirements for the Provision of Home Medical Equipment Services. *COMAR 10.07.05.05-1* A. A provider of home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .02—.03 of this chapter. B. An agency shall: (1) Ensure that personnel demonstrate competency in delivering and installing the equipment; (2) Provide education, training, and written instructions to the patient and his or her caregivers on the use of the equipment before the equipment is used, and provide retraining as needed; (3) Provide the patient and caregivers with the telephone number of persons who can deliver critical care on an emergency basis; (4) Provide the prescribing physician with a copy of the: (a) Qualifications, duties, and responsibilities of agency personnel who deliver the services, and (b) Instructions given to the patient and the patient's caregivers; (5) Maintain a clinical record for each patient receiving home medical equipment services; and (6) Ensure that the installation, maintenance, repair, and storage of home medical equipment meet with manufacturer's specifications. #### Regulation .06 Public Representation. *COMAR 10.07.05.06* A. An agency shall include the following information in all of the agency’s advertising and marketing materials: (1) The agency’s license number; and (2) The statement “Licensed as a residential service agency by the Maryland Department of Health, Office of Health Care Quality”. B. Misleading or False Advertising. (1) A person may not advertise, represent, or imply to the public that an agency is authorized to provide a service that the agency is not licensed, certified, or otherwise authorized by the Department to provide under this chapter. (2) A person may not advertise an agency in a misleading or fraudulent manner. (3) A person licensed as an agency may not advertise that it is licensed as a hospice, home health agency, or nursing referral service agency unless it is separately licensed with the Department as such. C. A person who violates this regulation is subject to referral for criminal prosecution and imposition of civil money penalties in accordance with Regulations .21—.23 of this chapter. #### Regulation .07 Inspection by the Department. *COMAR 10.07.05.07* A. Residential Service Agency to be Open for Inspection. (1) The Department or its designee may conduct announced or unannounced licensure inspections or complaint investigations to ensure compliance with the requirements of this chapter. (2) The agency shall be open for inspection by the Department during all hours identified in the agency’s application as routine business hours. B. Access to Agency and Sites Where Services Are Offered. Upon the request of the Department, an agency shall: (1) Make its offices available for inspection during other than its routine business hours; (2) Assist the Department in gaining access to sites where services are provided for the purpose of conducting inspections to: (a) Ensure that the agency is in compliance with the regulations of this chapter; and (b) Enable the Department to investigate and resolve complaints filed against the agency. C. Records and Reports. (1) Inspection. (a) A licensee shall maintain records and reports to support compliance with the regulations of this chapter. All records and reports shall be open to inspection by the Department. (b) Except for the records permitted to be stored off site, a licensee or licensee’s designee shall immediately, upon request, provide copies of records and reports, including medical records of clients, to the Department. The Department shall, if requested, reimburse the licensee for the cost of copying records and reports. (2) Maintenance. (a) The residential service agency shall maintain files on site pertaining to: (i) Current clients; (ii) Clients that have been discharged within the last 12 months; (iii) Current staff; (iv) Staff that have been discharged within the last year; and (v) Quality assurance activities. (b) All other records may be stored off site, but shall be available for inspection within 24 hours of the Department’s request. D. An agency shall make available upon request to clients, client representatives, potential clients, or federal, State, or local regulatory or law enforcement agencies any statements of deficiencies, reports, and plans of corrections. E. Notice of Violations. (1) If a complaint investigation or survey inspection identifies a regulatory violation, the Secretary shall issue a notice: (a) Citing the violation or deficiency; (b) Requiring the residential service agency to submit an acceptable plan of correction within 10 calendar days of receipt of the notice of violation or deficiency; (c) Advising the residential service agency that failure to correct cited violations or deficiencies may result in sanctions; and (d) Offering the residential service agency the opportunity for an informal dispute resolution conference (IDR). (2) The plan of correction referred to in §E(1)(b) of this regulation shall include the date by which the licensee shall complete the correction of each deficiency. Failure to return an acceptable plan of correction within the allotted timeframe may result in a sanction. (3) When a licensee requests an IDR as provided in §F of this regulation, the licensee shall file a plan of correction within the required time, except to the extent that the licensee contests specific findings. If the licensee contests specific findings, absent the Department’s directive, a licensee may delay submitting its plan of correction with respect to those specific findings until 5 days after the licensee is provided oral or written notice of the outcome of the IDR. F. Informal Dispute Resolution (IDR). (1) A licensee may request an informal dispute resolution conference (IDR) to question violations or deficiencies within 10 days of receiving the statement of deficiencies. The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by any supporting documentation. (2) At the discretion of the Office of Health Care Quality, the IDR may be held in person, by telephone, or in writing. In-person IDRs are informal in nature and are not attended by counsel. (3) The IDR process may not delay the effective date of any enforcement action. #### Regulation .08 Administration. *COMAR 10.07.05.08* A. Governing Authority. (1) The agency shall have a governing authority. (2) The governing authority shall: (a) Convene at least annually with management staff to review and advise the agency on policies; and (b) Keep minutes, including: (i) The participants of any meeting; (ii) Agenda items considered; and (iii) Actions taken. B. Policies and Procedures. (1) An agency shall develop and implement policies and procedures, including but not limited to: (a) Administration, including: (i) Scope of services; (ii) Delineation of services provided by the agency when the agency coordinates care within the agency or with another provider; (iii) Notification to the client or client representative with legal authority to make health care decisions of the agency’s responsibilities to coordinate care when appropriate; (iv) Admission criteria; (v) Assessment of potential clients before their acceptance into the program; (vi) Billing and service records, maintenance of charges, and similar items, except for those clients receiving services through a managed-care health benefits plan or third party payor, in which case records are maintained as required by the third party payor; (vii) Quality assurance program; and (viii) Clinical management, including assessment, plans, delegation, and supervision; (b) Personnel, including: (i) Job descriptions and educational qualifications for all employees and contractors; (ii) Skill assessments of all employees and contractors; and (iii) Health requirements for employees and contractors; (c) Patient care, including: (i) Provision of home health care services and criteria for determining the need for skilled services; (ii) Administration of drugs; (iii) Enteral and parenteral nutrition procedures; (iv) Frequency of client monitoring; and (v) Training and retraining of clients or their family members, when indicated; (d) Informed consent when: (i) A client or client representative with legal authority to make legal decisions, signs an informed consent form consenting to changes to the agency’s recommended plan of care; or (ii) A client signs an informed consent form consenting to assistance by a nonlicensed individual with treatments of a routine nature, or with the self-administration of medications; and (e) Environment and safety, including: (i) Preparation and storage of enteral formulas, intravenous therapies, other supplies, equipment, and similar items; (ii) Infection control procedures; (iii) Disposal of biomedical waste; (iv) Maintenance of equipment; and (v) Emergency procedures. (2) The Department may waive the requirement of a policy and procedure that is required in §B of this regulation upon the agency’s written explanation as to why the policy and procedure is inappropriate or unnecessary to the agency’s specific operation. (3) An agency that provides invasive equipment or supplies, such as intravenous therapy, shall arrange for 24-hour-a-day equipment maintenance service in case of equipment failure. #### Regulation .09 Complaint Process. *COMAR 10.07.05.09* A. Internal Complaint Process. An agency shall institute an internal client complaint process that includes: (1) Notice to the client or the client representative of the complaint process; (2) Protocols to investigate complaints; and (3) A mechanism for the receipt and timely investigation of written complaints that ensures that the client’s services will not be disrupted due to the filing of a complaint. B. Internal Complaint Investigations. (1) All investigation reports shall include: (a) Time, date, place, and individuals involved; (b) Complete description of the complaint; (c) Disposition of the complaint; and (d) Follow-up activities and steps taken to prevent its reoccurrence. (2) If the agency does not conduct a complaint investigation, the agency shall document in the complaint record the reason for not conducting an investigation. (3) An agency shall provide notice to the following persons regarding the disposition of a complaint: (a) Client, or if the client is incompetent, the client representative; (b) Client’s physician, if needed; and (c) Licensing or law enforcement agencies, when required by law. (4) An agency shall maintain records to support its internal complaint investigation process. C. An agency shall provide notice to clients of the Department’s complaint hotline number for complaints about services provided by the agency or services that the agency failed to provide. D. Availability of Internal Investigation Reports. (1) The agency shall make investigation reports available to the Department immediately upon request. (2) An agency shall provide a summary report of any complaint investigation for public inspection, upon request, to the extent permitted by law. #### Regulation .10 Employee, Independent Contractor, and Contractual Employee Requirements. *COMAR 10.07.05.10* A. An agency shall develop and implement policies and procedures to screen a prospective employee, independent contractor, or contractual employee who will provide services to clients. B. Screening. (1) Screening shall include: (a) A State criminal history records check or a private agency background check as required under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland; (b) Verification of current professional licensure or certification under Health Occupations Article, Annotated Code of Maryland; (c) A basic health screening, including tuberculosis screening; (d) Verification of references; (e) Verification of employment history; (f) Completion of I-9 forms for employment; (g) Verification of identity and employment eligibility of an employee, independent contractor, or contractual employee; (h) An in-person interview of an employee, independent contractor, or contractual employee before the individual is referred to clients; and (i) Completion of a skills assessment and demonstration before client referral. (2) An agency shall retain records of training in the personnel file. C. An agency shall maintain records of information described in §B of this regulation for each employee, independent contractor, or contractual employee and retain the information in the agency’s business office. D. An agency may not knowingly provide or refer a caregiver who is not certified to provide services to a client unless the client: (1) Does not require the caregiver to provide assistance with activities of daily living; (2) Only requires assistance with activities of daily living and in the judgment of the supervising nurse, there are no predictable adverse health consequences; or (3) Signs a waiver of skilled services form as required under Regulation .12D of this chapter. E. An agency shall provide or refer a certified caregiver to a client who requires: (1) A certified caregiver to perform activities of daily living; or (2) Administration of medication. F. If an agency is aware of an action or inaction by an individual who is provided or referred by the agency that may be grounds for action under Health Occupations Article, §§8-316 and 8-6A-10, Annotated Code of Maryland, the agency shall report the action or condition to the Board of Nursing and the Office of Health Care Quality immediately when the action or condition is known by the agency. G. A nursing administrator, a registered nurse, a licensed practical nurse, and a certified nursing assistant shall have immunity from liability as described in Courts and Judicial Proceedings Article, §5-709, Annotated Code of Maryland, for making a report to the Board of Nursing as required under §F of this regulation. Other persons are entitled to the immunity from liability as described in the Courts and Judicial Proceedings Article, §5-708, Annotated Code of Maryland, for making a report to the Board of Nursing as required under §F of this regulation. H. Use of Subcontract Agencies. If an agency subcontracts with another licensed agency to provide services, the subcontracting agency shall: (1) Verify personnel information outlined in §B of this regulation; and (2) Submit evidence to the contracting agency that verification has occurred. #### Regulation .11 Training. *COMAR 10.07.05.11* A. An agency shall ensure that individuals that are referred are trained appropriately to provide care that is needed by the agency’s clients. B. Sources other than the agency may provide training, as approved in writing by the Office of Health Care Quality. C. At a minimum, training for individuals providing care in clients’ homes shall include: (1) Instruction and supervised practice in relevant personal care services of the sick or disabled at home; (2) Identification of situations that require referral to a registered nurse, including significant changes in a client’s condition; (3) Record keeping; (4) Ethical behavior and confidentiality of information; (5) CPR; (6) Standard precautions for infection control; and (7) Prevention of abuse and neglect. #### Regulation .12 Services Provided. *COMAR 10.07.05.12* A. An agency shall take reasonable measures to ensure that all individuals who are referred to provide services to clients do so in accordance with Maryland laws and regulations, including but not limited to the Health Occupations Article, Annotated Code of Maryland. B. Provision of Services. (1) A registered nurse shall assess each new client who requires skilled services and assistance with the activities of daily living. (2) The registered nurse shall also: (a) Participate in developing the client’s plan of care and in assigning appropriate personnel; (b) Determine whether the client requires the services of a certified nursing assistant, or whether services may be provided by an individual who is not certified; and (c) Participate in training and retraining the individuals who will provide the care, when indicated. C. Plan of Care. (1) A client’s plan of care shall be based on assessments of the client’s health, function, and psychosocial condition. (2) An assessment of a client shall be completed: (a) When the client is requesting or requiring services regulated by this chapter; (b) Before the client receives services from the agency unless: (i) The client does not request skilled care or skilled services; and (ii) There is no reason to believe that the client requires skilled care or skilled services, such as discharge instructions requiring skilled care; (c) Within 48 hours of when the client begins services when the client requires, including but not limited to: (i) Wound and catheter care; (ii) Treatment of stage three or stage four skin ulcers; (iii) Ventilator services; (iv) Skilled monitoring, testing, and aggressive adjustment of medications and treatments where there is the presence of, or risk for, a fluctuating acute condition; (v) Monitoring of a chronic medical condition that is not readily controllable through available medications and treatments; (vi) Infusion therapy; (vii) Specialized intravenous therapies or nutrition support; (viii) Monitoring for being at high risk for health or safety complications which cannot be adequately managed; or (ix) A different level of care after notification of a significant change of condition; (d) At the request of the client or the client representative; (e) At least annually; and (f) Except in the following circumstances: (i) Weather-related emergencies; (ii) Natural disasters; or (iii) Federal, state, or local declaration of an emergency. (3) When a registered nurse determines in the nurse’s clinical judgment that the client does not require an assessment within 48 hours of a significant change of condition as provided in §C(2)(c) of this regulation, the registered nurse shall: (a) Document the determination in the client’s record; and (b) Ensure that an assessment of the client is conducted within 7 calendar days. (4) The agency shall ensure that the care plan developed for the client at a minimum addresses: (a) The services to be provided to the client, which are based on the assessment of the client; (b) When and how often the services are to be provided; (c) How and by whom the services are to be provided; (d) Long-range and short-range goals for the client; and (e) Physical needs, including safety measures to protect against injury. (5) Client care plans shall be reviewed by a registered nurse or another health care practitioner who is authorized to do so under Health Occupations Article, Annotated Code of Maryland, when appropriate. D. Informed Consent. (1) An adult client who is competent to make decisions or a client representative with legal authority to make health care decisions may consent to make changes to the agency’s recommended plan of care. (2) A cognitively capable adult client, but not a client representative with legal authority to make health care decisions, may waive the licensee’s recommendation of certified care services to be provided in the adult client’s home to assist with treatments of a routine nature, or with the self-administration of medications. (3) A cognitively capable adult client may waive the licensee’s recommended skilled care. (4) Consents. (a) The consent given under §D(1)—(3) of this regulation may be granted only after a discussion of the risks and benefits with the client or, if appropriate, the client representative with legal authority to make health care decisions. This discussion shall be reflected in an informed consent form. (b) The informed consent form shall be: (i) Signed and dated by the client, or the client representative with legal authority over health care decisions; and (ii) Documented in the client’s records. (c) A form confirming a waiver of skilled services shall be signed by a cognitively capable adult client and maintained in the client’s record. (5) Client medications shall be administered in accordance with §F of this regulation. E. Nursing Supervision. (1) For clients who require skilled services or assistance with the activities of daily living, an agency shall have a registered nurse to provide oversight for: (a) Implementation of the care plan; (b) Delegation; (c) Supervision; and (d) Training. (2) The registered nurse shall provide periodic, on-site supervision of care: (a) At least every 45 days if the staff administers medications to the client; (b) At least every 3 months if the staff assists the client with self-administration of medications; (c) At least every 4 months if the staff does not administer medications or assist the client with medication self-administration; or (d) At a greater frequency established by the registered nurse due to the client's medical condition or clinical status. (3) The agency shall maintain accurate documentation of the supervision that is provided by the registered nurse. F. Medication Administration. If agency employees, independent contractors, or contractual employees administer medications, the agency shall: (1) Provide for administration of drugs and treatments by licensed or certified staff consistent with Maryland law and the client’s plan of care, unless the client has executed an informed consent form under §D of this regulation; (2) Provide for drugs and treatments to be administered only as ordered by the physician; and (3) Document in the client’s clinical record: (a) Medications administered or taken; (b) Medication errors; and (c) Adverse drug reactions and corrective action. G. On-Call Services. The agency shall: (1) Establish a procedure by which current clients or their representatives may contact a representative of the agency by communication device at any time, 24 hours a day and 7 days a week; (2) Recognize and respond to emergency inquiries in a manner that is consistent with medical and nursing standards; (3) Ensure that the inquiry is directed to an individual for response as required by medical and nursing standards; (4) Ensure that the individual responds to an inquiry not later than 1 hour after the inquiry is received by the agency or sooner as necessitated by medical standards; (5) Maintain a log of inquiries that includes the identity of the response personnel, content of the inquiry, and the time of each inquiry; and (6) Provide clients or the client representatives with written procedures and the phone number for on-call service. #### Regulation .13 Client Representative. *COMAR 10.07.05.13* A. An agency shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advanced directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with the authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements of Estates and Trusts Article, Title 17, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) Any other person, if that person was designated by a client who was competent at the time of designation, and the client or client representative has provided the agency with documentation of the designation. B. An agency may not recognize the authority of a client representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. An agency shall: (1) Document in the client’s record the name of the person, if any, with the authority identified in §A of this regulation; or (2) Include the documentation creating the authority in the record. #### Regulation .14 Clinical Records. *COMAR 10.07.05.14* A. With the exception of §B of this regulation, an agency shall ensure that a clinical record is maintained for each client in a manner that ensures security and confidentiality, and includes at a minimum: (1) The documentation required by §D of this regulation; (2) Any currently effective health care orders; (3) Nurse’s assessment (4) Rehabilitation plans, if appropriate; (5) The care plan; (6) Medications administered or taken, including: (a) Dosage; (b) Route of administration; and (c) Frequency; (7) History of sensitivities or allergic reactions; (8) Nutritional requirements, including specific dietary plans; (9) Medically necessary supplies and equipment; (10) Care notes; (11) The name, address, and telephone number of: (a) The client’s physicians; and (b) The client representative; and (12) The following documents for each client upon discharge: (a) Directions for the safe continuation of care after discharge; and (b) If skilled services have been provided, a discharge summary that includes the reason for discharge. B. An agency that provides care to clients who are assessed as not requiring certified caregivers or skilled services shall maintain a client record, including but not limited to: (1) Nursing assessment; (2) Plan of care; (3) Services provided; (4) Any significant change of condition; and (5) Any other pertinent information regarding the client being served. C. An agency shall develop policies and procedures to ensure that all information relating to a client’s condition or preferences, including any significant change of condition as defined in Regulation .02B(27) of this chapter, is documented in the client’s record and communicated in a timely manner to: (1) The client; (2) The client representative, if appropriate; and (3) All appropriate health care professionals and staff who are involved in the development and implementation of the client’s care plan. D. Care Notes. (1) Appropriate staff shall write care notes for each client, at a minimum: (a) On admission and at least weekly; (b) Upon any significant changes in the client’s condition; and (c) When the care plan is modified. (2) The agency shall ensure that all notes and reports that are entered in the clinical record, which may include an electronic record, are detailed, legible, chronological, dated, and signed with the name and title of the individual rendering the service. E. The agency may accept orders for care with an electronic signature. Orders may be received by, but not limited to, mail, hand delivery, or facsimile transmission. #### Regulation .15 Maintenance of Records. *COMAR 10.07.05.15* A. The agency shall maintain a client’s record for 5 years after the client is discharged. For a client younger than 18 years old, the agency shall maintain the client’s record after discharge until the resident is 21 years old, or for 5 years after the record is made, whichever is later, except as otherwise provided in Health-General Article, §4-403, Annotated Code of Maryland. B. If an agency ceases operation, the agency shall make arrangements to return the records to the client or client representative with legal authority to make health care decisions, or retain the records as required by §A of this regulation. C. An agency shall: (1) Maintain the privacy and confidentiality of a client’s medical records; (2) Release medical records or medical information about a client only with the written consent of the client or client representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (3) Maintain and dispose of a client’s medical records in accordance with Health-General Article, Title 4, Subtitle 3 and 4, Annotated Code of Maryland. D. In addition to the provisions of §§A—C of this regulation, the agency shall establish and implement procedures that ensure that: (1) Records of discharged clients are completed no later than 30 days after the date of discharge; and (2) Safeguards are in place to protect clinical record information against loss, destruction, or illegal or unauthorized use. #### Regulation .16 Client’s Rights and Responsibilities. *COMAR 10.07.05.16* A. The agency shall ensure that agency staff develops and implements written policies and procedures concerning clients’ rights and responsibilities. B. The agency shall make the policies and procedures available to clients or client representatives. C. The policies and procedures shall ensure that the agency provides the client or client representative with: (1) An estimate of costs associated with the services requested by the client; (2) A statement clarifying the costs that the client or client representative will be responsible for if services are not covered by third-party payors; (3) Fully itemized billing statements, including dates of services and unit charge, to be made available on request of the client or client representative; (4) The name of the caregiver or caregivers referred by the agency to provide the service or services; (5) The name and contact information for the individual who is responsible for supervising the client’s care; (6) The telephone number where a client or the client representative can contact the agency 24 hours a day, 7 days a week regarding care; and (7) Disclosure of any subcontractual relationship with any individual or agency to be assigned or referred to provide care to the client. D. Rights. (1) A client of an agency or, if appropriate, the client representative with legal authority to make health care decisions has the right to: (a) Be treated with consideration, respect, and full recognition of the client’s human dignity and individuality; (b) Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations; (c) Participate in the development of the client’s care plan and medical treatment; (d) Refuse treatment after the possible consequences of refusing treatment have been fully explained; (e) Privacy; (f) Be free from mental, verbal, sexual, and physical abuse, neglect, involuntary seclusion, and exploitation; and (g) Confidentiality. (2) A client or client representative has the right to: (a) Make suggestions or complaints, or present grievances on behalf of the client to the agency, government agencies, or other persons without the threat or fear of retaliation; (b) Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the participant may have; and (c) Have access to the procedures for making a complaint to the Office of Health Care Quality, and to: (i) The Adult Protective Services Program of the local department of social services, if the client is an adult; or (ii) The Child Protective Services Program of the local department of social services, if the client is a minor. E. Advanced Directives. With the exception of durable medical equipment agencies, an agency shall: (1) Provide information to a client about advance directives and the right to have an advance directive; and (2) Obtain information regarding the client’s advance directives to determine whether the advance directive information has an impact on care provided. F. Client Directed Care. The agency shall honor the right of: (1) A cognitively capable adult client, or a client representative with legal authority to make health care decisions, to refuse any portion of planned treatment or other portions of the treatment plan, except where medical contraindications to partial treatment exist; and (2) A cognitively capable adult client to have an individual who is not certified to provide assistance with activities of daily living and treatments of a routine nature if the client signs a waiver of skilled services detailing the potential risks and benefits of waiver as required under Regulation .12D of this chapter. G. Informed Consent. The agency shall provide sufficient information to the client or the client representative to allow the client or the client representative to make an informed decision regarding treatment as required under Regulation .12D of this chapter, including: (1) The purpose and nature of an evaluation or treatment regimen; (2) Alternatives to treatment; (3) Side effects and benefits of a proposed treatment regimen and the alternatives to the treatment; (4) The estimated cost of the treatment and the alternatives; and (5) The right to withdraw from treatment at any time, including the risks associated with withdrawing from treatment. H. Client Participation. The agency shall allow a client, or client representative with legal authority to make health care decisions, to accept or reject, at the client’s or client representative’s discretion without fear of retaliation from the agency, any employee, independent contractor, or contractual employee that is referred by the agency. #### Regulation .17 Special Requirements for the Provision of Intravenous or Related Therapies. *COMAR 10.07.05.17* A. This regulation applies to intravenous or related therapy provided in the home. B. A provider of intravenous or related therapies shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter. C. Specialized intravenous therapies and nutritional support services administered enterally or parenterally shall be considered skilled nursing functions. D. Medications. (1) Medications and preparations used in the provision of intravenous or nutritional support shall be obtained from a licensed pharmacy. (2) The agency shall document any adverse reactions associated with the therapy and notify the client’s physician. E. Education and Training. When an agency provides intravenous or related therapies, the agency shall provide: (1) Education, training, and written instructions to the client, client representative, or the individual caring for the client before the initiation of treatment, which includes: (a) Feeding formulation or medication preparation; (b) Administration of the therapy; (c) Accessing private care; (d) Equipment maintenance; (e) Recognition of complications of therapy, adverse medication reactions, and equipment malfunctions; and (f) Mechanisms for accessing a clinician during business hours and at any time after hours for questions related to drug therapy, drug administration, or equipment troubleshooting or malfunctions; and (2) Retraining and a review to the client, client representative, or the individual caring for the client as needed or requested. F. The agency shall maintain a clinical record for a client receiving intravenous or related therapies, which, in addition to the documents required to be maintained in accordance with the provisions set forth in Regulations .14 and .15 of this chapter, includes the following: (1) Results of training or retraining of the client, client representative, or the individual caring for the client; (2) Composition, indication for use, role, and mode of administration of feeding formulas or medications; and (3) Summary statement at termination of the intravenous or related therapy which includes the results of therapy, complications, outcome, and disposition of the client. #### Regulation .18 Special Requirements for the Provision of Ventilator Services. *COMAR 10.07.05.18* A. A provider of ventilator services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter. B. This regulation applies to ventilator services provided in the home, including: (1) Volume ventilation; (2) Pressure ventilation; (3) Emergency back-up power systems; (4) Alarms and troubleshooting equipment; (5) Emergency resuscitation; and (6) All related medical equipment used with the provision of ventilator services, including but not limited to: (a) Nebulizers; (b) Suction equipment; and (c) Oxygen. C. Education and Training. When an agency provides ventilator services, the agency shall: (1) Use either a licensed registered nurse or a licensed respiratory care practitioner to supervise the provision of education and training and written instruction to the client, client representative, or individual caring for the client; and (2) Provide retraining and review on a monthly basis, and as frequently as necessary. D. Client Record. For a client receiving ventilator services, the agency shall maintain a clinical record, in addition to the documents required to be maintained in accordance with the provisions set forth in Regulations .14 and .15 of this chapter, that includes the following: (1) An evaluation of use of the ventilator and all related medical equipment by the client, client representative, or individual caring for the client that includes: (a) Training at least monthly on the provision of ventilator services; and (b) Retraining, more frequently as needed, on the provision of ventilator services; (2) A prescription that includes the mode, frequency, and ventilator settings; (3) Respiratory and all specialized services, including the results, complications, and outcomes; (4) Physician orders and pharmacy-dispensed respiratory medications; (5) Evidence that the client, client representative, or individual caring for the client was instructed that medications are to be obtained from a licensed pharmacy; and (6) A discharge summary when a client is no longer receiving ventilator-related services. #### Regulation .19 Special Requirements for the Provision of Home Medical Equipment Services. *COMAR 10.07.05.19* A. An agency that provides home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01—.16 of this chapter. B. Education and Training. When an agency provides home medical equipment services, the agency shall: (1) Ensure that its personnel demonstrate competency in delivering and installing the equipment; (2) Provide education, training, and written instructions to the client, the client representative, or the individual caring for the client on the use of the equipment at the time of installation; and (3) Provide the client, client representative, or the individual caring for the client the telephone number of the agency in the event of equipment failure or emergency. C. Upon request, an agency shall provide the prescribing physician with a copy of the: (1) Qualifications, duties, and responsibilities of agency personnel who deliver the home medical equipment services; and (2) Instructions given to the client and the client’s caregivers. D. Client Records. The agency shall maintain a client record for each client receiving home medical equipment services in accordance with industry standards, including but not limited to: (1) Physician order for the provision of home medical equipment services; (2) Any significant change of condition; (3) Services provided; and (4) Any other pertinent information regarding the client being served. E. An agency shall ensure that the installation, maintenance, repair, and storage of home medical equipment comply with the manufacturer’s specifications. #### Regulation .20 Sanctions. *COMAR 10.07.05.20* A. If the Secretary determines that an agency has violated this chapter, the Secretary, in addition to the sanctions set forth in Regulations .21—.27 of this chapter may: (1) Restrict the number of clients the agency may serve; (2) Limit the types of clients an agency may serve; (3) Require the licensee, and any of its staff, to receive remedial instruction in a specific area; (4) Require the agency to use the services of a management firm that is approved by the Department; (5) Mandate staffing patterns that specify the number of personnel or personnel qualifications, or both; (6) Direct the licensee to correct the violations in a specific manner or within a specified timeframe; (7) Notify, or require the agency to notify, the client, the client representative, or the family of any client who is affected by the noncompliance; (8) Increase the frequency of monitoring visits during a specified period of time; or (9) Establish certain conditions for continued operation, including time limits for continued operation and for compliance. B. If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction, the Secretary may suspend or revoke the license. C. A licensee aggrieved by the imposition of a sanction under §A(1) or (2) or B of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .21 Civil Money Penalties. *COMAR 10.07.05.21* A. The Secretary may impose a civil money penalty on an agency if a deficiency or continuing pattern of deficiencies exists in the residential service agency. B. In determining whether a civil money penalty will be imposed, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The extent to which the deficiency or deficiencies are part of a continuing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the clients of the agency that is caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of, the agency to correct the deficiency or deficiencies; and (5) An agency’s prior history of compliance. C. If the Department determines that a deficiency or a continuing pattern of deficiencies exists, the Department shall notify the agency of the deficiency or deficiencies and may: (1) Permit the agency the opportunity to correct the deficiencies by a specified date; (2) Impose a civil money penalty of up to $1,000 per day until sustained compliance is achieved; or (3) Impose a civil money penalty for each instance of violation. D. If the Department permits an agency the opportunity to correct the deficiencies by a specific date, and the agency fails to comply with this requirement, the Department may impose a civil penalty of up to $1,000 for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. E. If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the: (1) Deficiency or deficiencies on which the order is based; (2) Amount of the civil money penalties to be imposed; (3) Manner in which the amount of the civil money penalty was calculated; and (4) Appeal rights. #### Regulation .22 Amount of Civil Money Penalties. *COMAR 10.07.05.22* A. A civil money penalty imposed on a person under this chapter may not exceed $10,000 per instance or, as provided in Regulation .21 of this chapter, $1,000 per day. B. In setting the amount of the civil money penalty under this chapter, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The degree of risk to the health, life, or safety of the clients of the agency that is caused by the deficiency or deficiencies; (3) The efforts made by, and ability of, the agency to correct the deficiency or deficiencies; (4) Whether the amount of the civil money penalty will jeopardize the financial ability of the agency to continue operation as an agency; (5) Prior history of compliance by the agency; and (6) Other factors as justice may require. C. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .23 Civil Money Penalties — Hearings. *COMAR 10.07.05.23* A. A hearing on the appeal shall be held consistent with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter. #### Regulation .24 Emergency Suspension. *COMAR 10.07.05.24* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action B. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action, and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the licensee of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is suspended by emergency action: (1) The agency shall immediately return the license to the Department; (2) The agency shall immediately stop providing services; and (3) The agency shall notify competent clients and client representatives about the suspension and make every reasonable effort to assist them in making other arrangements for services. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .28 of this chapter. F. Show Cause Hearing. (1) In addition to the right to request an evidentiary hearing in accordance with Regulation .28 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension before the evidentiary hearing. (2) The show cause hearing shall be held promptly. (3) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension. (4) The show cause hearing shall be conducted before the Secretary, or a designee of the Secretary, who: (a) Shall determine procedural issues; (b) May impose reasonable time limits on each party’s oral argument; and (c) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. (5) At the conclusion of the show cause hearing, the Secretary or the Secretary’s designee may: (a) Affirm the order of summary suspension; (b) Rescind the order of summary suspension; (c) Enter into a consent order; or (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (6) After the show cause hearing, if the Secretary or the Secretary’s designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings in accordance with Regulation .28 of this chapter. G. If the Secretary’s final decision does not uphold the emergency suspension, the agency may resume operation. #### Regulation .25 Denial or Revocation of a License. *COMAR 10.07.05.25* The Secretary, for cause shown, may deny, revoke, or refuse to reissue any license issued for inability or failure to comply with the regulations of this chapter. This action is subject to the provisions of the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland. #### Regulation .26 Notice to Clients. *COMAR 10.07.05.26* Unless otherwise ordered by the Secretary, the agency shall notify each competent client and each client representative within at least 30 days of: A. Any significant change of licensure status; B. A voluntary surrender of its agency license; or C. Denial, revocation, or suspension of the license. #### Regulation .27 Penalty for Unlicensed Operation. *COMAR 10.07.05.27* A person that operates a residential service agency without a license may be assessed a civil money penalty by the Department not to exceed $10,000 per violation and, additionally, is guilty of a misdemeanor and, on conviction, is subject to a criminal fine not exceeding $1,000 for the first offense and $10,000 for each subsequent offense. Each day that a violation is continued after the first conviction is a separate offense. #### Regulation .28 Hearings. *COMAR 10.07.05.28* A. An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality, not later than 30 days after receipt of notice of the Secretary’s action. The request shall include a copy of the Secretary’s action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03 and 28.02.01. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in State Government Article, §10-205, Annotated Code of Maryland. E. An aggrieved party may file exceptions as provided in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. ### Chapter 06 — Hospital Patient Safety Program **Authority:** Health-General Article, §§19-308 and 19-319, Annotated Code of Maryland **Administrative History:** Effective date: March 15, 2004 (31:5 Md. R. 448) **Administrative History:** Regulation .15B amended effective February 26, 2018 (45:4 Md. R. 206) **Administrative History:** Regulation .17 adopted effective February 26, 2018 (45:4 Md. R. 206) #### Regulation .01 Purpose. *COMAR 10.07.06.01* The purpose of this chapter is to provide a safe environment for patients by requiring hospitals to: A. Identify adverse events; B. Encourage reporting of near-misses; C. Assess and prioritize near-misses and adverse events based on level of disability or potential disability to patients; D. Determine the appropriate hospital response based on level of disability or potential disability; E. Conduct a root cause analysis of: (1) All level 1 events; (2) All level 2 events; and (3) If warranted, any near-miss or other adverse event; F. Conduct an appropriate investigation of adverse events and near-misses that do not require or warrant a root cause analysis; G. Provide a process by which the concerns of patients can be addressed; and H. Provide a process to notify a patient or, if appropriate, a patient's family, whenever an outcome of care differs significantly from an anticipated outcome. #### Regulation .02 Definitions. *COMAR 10.07.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Action plan” means a written document that includes: (a) Specific measures to correct problems or areas of concerns; (b) Specific measures to address areas of system improvement; (c) Time frames for implementation of any specific measures; and (d) Title of responsible individual to monitor implementation and effectiveness. (2) “Adverse event” means an unexpected occurrence related to an individual's medical treatment and not related to the natural course of the patient's illness or underlying disease condition. (3) “Department” means the Maryland Department of Health. (4) “Level 1 adverse event” means an adverse event that results in death or serious disability. (5) “Level 2 adverse event” means an adverse event that requires a medical intervention to prevent death or serious disability. (6) “Level 3 adverse event” means an adverse event that does not result in death or serious disability and does not require any medical intervention to prevent death or serious disability. (7) “Medical review committee” has the meaning stated in Health Occupations Article, §1-401, Annotated Code of Maryland. (8) “Near-miss” means a situation that could have resulted in an adverse event but did not, either by chance or through timely intervention. (9) “Patient safety program” means an ongoing, proactive program for identifying risks to patient safety and reducing medical errors which is one component of the hospital-wide risk management program. (10) “Root cause analysis” means a medical review committee process as defined under Health Occupations Article, §1-401, Annotated Code of Maryland, for identifying the basic or contributing causal factors that underlie variations in performance associated with adverse events or near-misses. (11) “Serious disability” means a physical or mental impairment that substantially limits one or more of the major life activities of an individual lasting more than 7 days or still is present at the time of discharge. #### Regulation .03 Patient Safety Program. *COMAR 10.07.06.03* A. General. On or before March 15, 2004, a hospital shall have in effect a patient safety program that meets the requirements of this chapter. B. Duties of the Hospital. (1) The hospital shall identify an individual as patient safety coordinator who shall: (a) Coordinate patient safety activities; (b) Facilitate assessment and determination of the appropriate response to reported near-misses and adverse events related to patient care; (c) Monitor root cause analyses and any actions resulting from a root cause analysis; and (d) Provide for flow of information among quality assurance, credentialing, peer review, and any patient safety committee. (2) The hospital shall establish: (a) Patient safety education programs for all staff; and (b) An internal staff committee structure in accordance with Health Occupations Article, §1-401, Annotated Code of Maryland to conduct a review and evaluation of patient safety activities in accordance with this chapter. (3) The governing board of a hospital shall develop a process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program. (4) Before a committee may operate or review patient safety activities under this chapter, a hospital shall require that the committee meet the requirements for a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland. #### Regulation .04 Near-Miss and Adverse Event Reporting and Determination of Appropriate Response. *COMAR 10.07.06.04* A. The hospital shall develop and encourage a supportive environment that permits spontaneous identification, open discussion, and timely and accurate reporting of near-misses and adverse events. B. The hospital shall establish a clear and well-defined near-miss and adverse event identification and reporting process that shall: (1) Encourage reporting of near-misses and require reporting of adverse events; (2) List and describe examples of adverse events that shall be reported; (3) Designate a hospital representative to whom a near-miss is encouraged to be reported or to whom an adverse event shall be reported; (4) Provide a time frame within which the near-miss is encouraged to be reported or within which an adverse event shall be reported; (5) Require that an individual employed by the hospital or appointed to the medical staff and who is aware of an adverse event shall report the adverse event in accordance with this chapter; (6) Develop a procedure to coordinate receipt of all adverse events and near-misses and to prioritize adverse events and near-misses based on level of disability or potential disability; and (7) Develop a procedure to assign an appropriate response to level 1 and level 2 adverse events, other adverse events, and near-misses. #### Regulation .05 Procedures for Level 1 and 2 Adverse Events and Certain Near-Misses. *COMAR 10.07.06.05* A. When a level 1 or 2 adverse event, or a near-miss that warrants a root cause analysis occurs, the hospital shall: (1) Provide immediate care to the patient; (2) Identify any immediate corrective action to prevent reoccurrence; (3) Identify and report the event in accordance with the hospital's reporting process; (4) Complete a root cause analysis within 60 days of the time that the hospital has knowledge of the occurrence; (5) Develop and implement an action plan to correct any systems problems; (6) Share any pertinent information with quality assurance or other medical review committees; and (7) Aggregate data to determine patterns or trends. B. All patient safety activities shall be conducted by a medical review committee established under Health Occupations Article, §1-401, Annotated Code of Maryland. #### Regulation .06 Root Cause Analysis. *COMAR 10.07.06.06* A. The hospital shall appoint an interdisciplinary root cause analysis team that shall include: (1) Individuals who have knowledge of the event or near-miss; (2) Representatives of hospital leadership; and (3) Individuals with expertise in the subject matter of the event. B. The root cause analysis team shall interview and permit participation of individuals who were directly involved in the event or near-miss and allow the individual to participate in the root cause analysis as appropriate. C. The root cause analysis shall examine the cause and effect of the event through an impartial process by: (1) Analysis of human and other factors; (2) Analysis of related processes and systems; (3) Analysis of underlying cause and effect systems through a series of “why” questions; (4) Identification of risks and possible contributing factors; and (5) Determination of improvement in processes or systems. D. A root cause analysis shall: (1) Be internally consistent; and (2) Include consideration of relevant literature and best practices. E. The hospital shall provide feedback including changes to hospital policy or procedure resulting from the root cause analysis to hospital employees and staff who were involved in the event or near-miss and to other employees or staff who would benefit from the feedback. #### Regulation .07 Procedures for Level 3 Adverse Events and Certain Near-Misses. *COMAR 10.07.06.07* A. If the event is not a level 1 or 2 event or a near-miss that warrants a root cause analysis, the hospital shall conduct an evaluation of the event to determine any problem area and corrective action. B. All events shall be aggregated by type and level to determine any patterns or trends. C. The hospital is encouraged to evaluate and trend all near-misses to determine any system problems. D. The hospital shall monitor the results and effectiveness of all action plans. #### Regulation .08 Information Sharing. *COMAR 10.07.06.08* The patient safety program shall require that the quality assurance and other medical review committees share information and take any appropriate action concerning near-misses and adverse events. #### Regulation .09 Reports to the Department. *COMAR 10.07.06.09* A. A hospital shall report any level 1 adverse event to the Department within 5 days of the hospital's knowledge that the event occurred. B. A hospital shall submit the root cause analysis and action plan for the level 1 adverse event to the Department within 60 days of the hospital's knowledge of the occurrence. C. Any root cause analysis and any other medical review committee information submitted to the Department and the identity of individuals appointed to the interdisciplinary root cause analysis team are confidential under Health Occupations Article, §1-401, Annotated Code of Maryland and are not discoverable, disclosable, or admissible as evidence in any civil action or available under the Maryland Public Information Act. D. If the Department receives a complaint alleging a level 1 adverse event, the Department may accept the root cause analysis as a hospital's internal investigation under Health-General Article, §19-309(b), Annotated Code of Maryland. #### Regulation .10 Documentation. *COMAR 10.07.06.10* Actions taken by the quality assurance and medical staff credentialing and peer review committees shall be documented in committee minutes. #### Regulation .11 Patient Complaint Program. *COMAR 10.07.06.11* A. In accordance with this regulation, the patient safety program shall include a formal written program for addressing patient complaints. B. The hospital shall provide patients with information regarding the hospital's patient complaint program including: (1) The name of the hospital's representative that the patient may contact if the patient wishes to make a complaint; and (2) The hospital representative's phone number or address. C. The hospital's representative shall treat the complainant with dignity and courtesy and due regard for the individual's privacy. D. The hospital's representative shall provide the complainant with information about the complaint including: (1) The hospital representative that the patient may contact for information regarding the complaint; (2) The procedure for investigating the complaint; (3) The length of time in which the complainant can expect a response or resolution to the complaint; and (4) Notice that the patient may contact the Department at a specified telephone number or address with any complaint. E. The hospital's representative shall document the complaint and any action taken concerning the complaint or the hospital function complained about. F. Patient Safety Program Requirement—Notice to Patients and Families of Unanticipated Outcomes. The hospital shall inform the patient and, if appropriate, the patient's family whenever a final outcome of care differs significantly from an anticipated outcome. #### Regulation .12 Interhospital Notification Of Level 1 or Level 2 Adverse Events. *COMAR 10.07.06.12* A. A hospital that admits a patient with a condition resulting from a level 1 or level 2 adverse event that the hospital perceives may be related to care that was provided at another Maryland hospital and that appears to be unknown to the other hospital at the time of discharge shall notify and provide any necessary information to the appropriate medical review committee at the hospital where the adverse event allegedly occurred. B. The hospital where the event allegedly occurred shall conduct a root cause analysis and provide notice to the Department in accordance with this chapter. C. The hospital where the event allegedly occurred shall notify the patient or the patient's family in accordance with this chapter. D. All communication that occurs in accordance with §§A—B of this regulation is confidential under Health Occupations Article, §1-401, Annotated Code of Maryland. #### Regulation .13 Records. *COMAR 10.07.06.13* The hospital shall maintain records that document the operation of its patient safety program. #### Regulation .14 Documentation. *COMAR 10.07.06.14* A. On or before March 15, 2004, the hospital shall send to the Secretary a written description of its patient safety program that includes: (1) The name of the patient safety coordinator; (2) The board policy statement relevant to patient safety activities including the process to review the hospital's patient safety program and to determine the effectiveness of the hospital's patient safety program; (3) A description of the near-miss and adverse event identification and reporting process; (4) A list of examples of adverse events that shall be reported; (5) A description of the process for determining which near-misses warrant a root cause analysis to be conducted; (6) A description of the near-miss and adverse event review, prioritization, evaluation, and root cause analysis process; (7) A description of the process used to provide notification to a patient, and, if appropriate, to a patient's family whenever an outcome of care differs from an anticipated outcome; and (8) A description of the formal written patient complaint process. B. The hospital shall notify the Secretary of any change in its patient safety program related to the description required by this regulation within 30 days of the effective date of the change. #### Regulation .15 Plan of Correction. *COMAR 10.07.06.15* A. If the Department notifies a hospital that the patient safety program of the hospital does not meet the requirements of this chapter, the hospital shall submit a plan indicating the steps the hospital shall take to meet the requirements of this chapter. B. The plan shall be sent to the Secretary within 10 days after the Department notifies the hospital that the hospital does not meet the requirements of this chapter. #### Regulation .16 Penalties. *COMAR 10.07.06.16* If a hospital fails to have in effect a patient safety program in accordance with this chapter, then the Secretary may impose on the hospital the following penalties: A. Revocation of the hospital's license; or B. A fine of $500 for each day that the hospital is in violation of this chapter. #### Regulation .17 Departmental Obligations. *COMAR 10.07.06.17* The Department shall: A. Provide feedback to hospitals regarding submitted root cause analyses within 60 days of receipt; and B. Release an annual public report containing a compilation of de-identified data regarding the type and outcomes of reported adverse events. ### Chapter 07 — Nursing Referral Service Agencies **Authority:** Health-General Article, Subtitle 19-4B, Annotated Code of Maryland **Administrative History:** Effective date: November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .04A, E amended effective March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Purpose. *COMAR 10.07.07.01* The purpose of this chapter is to set minimum standards for licensure of nursing referral service agencies in Maryland. This chapter does not preclude a nursing referral service agency from operating with independent contractors. #### Regulation .02 Definitions. *COMAR 10.07.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means normal daily activities including: (a) Bathing, toileting, and personal hygiene; (b) Dressing; (c) Meal preparation and eating; (d) Companionship; and (e) Assistance with physical transfer and ambulation. (2) “Agency” means a licensed nursing referral service agency as defined in §B(8) of this regulation. (3) “Care provider” means an individual who provides health care services and assistance to a client in the activities of daily living including: (a) Bathing, toileting, and personal hygiene; (b) Dressing; (c) Meal preparation and eating; (d) Companionship; and (e) Assistance in physical transfer and ambulation. (4) “Department” means the Maryland Department of Health. (5) “Home health aid services” means personal and health care services delivered to a client by a care provider. (6) “License” means a document issued by the Secretary to a person to operate a nursing referral service agency in Maryland. (7) “Licensed or certified health professional” means an individual who is licensed or certified under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in this State. (8) “Licensee” means a person to whom a license is issued by the Secretary to operate a nursing referral service agency. (9) “Nursing referral service agency” means one or more individuals engaged in the business of screening and referring, directly or in accordance with contractual arrangements that may include independent contractors, licensed health professionals or care providers to clients for the provision of nursing services, home health aid services, or other home health care services at the request of the client. (10) “Residence” means a place where an individual resides and may include a private home, a nursing facility, an assisted living program, or other type of residential unit. (11) “Secretary” means the Secretary of Health. #### Regulation .03 License Required. *COMAR 10.07.07.03* A. A person, partnership, corporation, association, or other business entity may not conduct, operate, or maintain a nursing referral service agency in this State before being licensed by the Secretary. B. This chapter does not limit the right of any person who holds a license issued under Health-General Article or Health Occupations Article, Annotated Code of Maryland, to act as authorized by that license. #### Regulation .04 Licensing Procedures. *COMAR 10.07.07.04* A. Application for License. (1) A person desiring to conduct, operate, or maintain a nursing referral service agency in this State shall file an application with the Secretary, on the written or electronic form provided by the Secretary. (2) The application for licensure shall contain the name and address of each officer and the director of the nursing referral service agency. (3) Along with the application, the applicant shall submit a: (a) Nonrefundable 3-year license fee of $1,000 payable to the Department; and (b) Copy of the agency's policies and procedures as specified in Regulation .08B(1) of this chapter. B. Additional Requirements. The applicant shall: (1) Demonstrate compliance with all applicable federal, State, and local laws and regulations; and (2) Maintain records to support compliance with the regulations of this chapter and make the records available to the Department upon request. C. After reviewing the application for licensure, the Secretary shall: (1) Approve the application and issue a 3-year license to the applicant if the applicant complies with all requirements of this chapter; or (2) Deny the application if the applicant does not comply with the requirements of this chapter. D. A 3-year license expires 3 years from the date of its issuance, unless it is otherwise revoked or suspended by the Department. E. License Renewal. (1) The agency shall file an application for relicensure on the written or electronic form provided by the Secretary at least 60 days before the expiration of its current license. (2) A licensee shall submit to the Department: (a) An application for license renewal; (b) A nonrefundable license renewal fee of $1,000 payable to the Department; and (c) Updates, if any, to the agency's policies and procedures as specified in Regulation .08B(1) of this chapter. #### Regulation .05 Posting Of License. *COMAR 10.07.07.05* A nursing referral service agency shall post its license conspicuously onsite so that it is clearly visible to the general public. #### Regulation .06 Restrictions on a License. *COMAR 10.07.07.06* A. A licensee may not, under any circumstances, transfer or reassign its nursing referral service agency license to another person. B. If the agency ceases to operate for any reason, the license is void and the licensee shall immediately return the license to the Department. #### Regulation .07 Inspections by the Secretary of Health. *COMAR 10.07.07.07* A. An applicant or a licensee shall maintain records to support compliance with this chapter and ensure that all records are open to inspection by the Department. B. An applicant or a licensee shall assist the Department in conducting an inspection if the Department determines that the assistance is necessary to enable the Department to conduct the inspection. C. If the Department issues deficiencies after an inspection, an agency shall submit a written plan of correction to the Department within 10 business days of receiving the Department's notice of deficiencies. #### Regulation .08 Administration. *COMAR 10.07.07.08* A. Contractual Arrangements. The regulations of this chapter do not preclude a nursing referral service agency from operating with independent contractors. B. Agency Referrals. An agency shall: (1) Develop and implement policies and procedures to screen licensed or certified health professionals and care providers that include the following: (a) A State criminal history records check or a private agency background check in accordance with Health-General Article, §19-4B-03(c), Annotated Code of Maryland; (b) Verification of current professional licensure or certification under the Health Occupations Article, Annotated Code of Maryland; (c) A basic health screening including tuberculosis screening; (d) Verification of references; (e) Verification of employment history; (f) Completion of I-9 forms; and (g) An in-person interview of a licensed or certified health professional and care provider before any referral of the individual is made to a client; and (2) Disclose to the client or the client's representative whether or not the agency has made a determination that the referral is appropriate to the needs of a client and is in compliance with applicable titles of Health Occupations Article, Annotated Code of Maryland. C. Complaint Process. (1) An agency shall institute an internal client complaint investigation process that includes: (a) Notice to the client or the client's representative of the complaint process; and (b) Protocols to investigate complaints. (2) An agency shall provide notice to clients of the Department's complaint hotline number for complaints about services provided by an individual that is referred by the agency. D. Client Participation. An agency shall allow clients to accept or reject, at their discretion, any licensed or certified health professional or care provider that is referred by the agency. #### Regulation .09 Sanctions. *COMAR 10.07.07.09* A. The Secretary may deny, suspend, revoke, or refuse to reissue any license for inability or failure to comply with this chapter. Any action taken to deny, suspend, or refuse to issue a license is subject to provisions of the Administrative Procedure Act, State Government Article, §10-201 et seq., Annotated Code of Maryland. B. The Secretary, in addition to or instead of the sanctions set forth in §A of this regulation may direct the licensee to establish certain conditions for continued operation, including time limits for compliance. #### Regulation .10 Penalty for Unlicensed Operation. *COMAR 10.07.07.10* A person that operates a nursing referral services agency without a license is guilty of a misdemeanor, and on conviction is subject to a fine not exceeding $1,000 for the first offense and $10,000 for each subsequent offense. Each day that a violation is continued after the first conviction is a separate offense. ### Chapter 08 — Freestanding Medical Facilities **Authority:** Health-General Article, §2-104 and Title 19, Subtitle 3A, Annotated Code of Maryland **Administrative History:** Effective date: February 12, 2007 (34:3 Md. R. 297) **Administrative History:** Regulation .04B amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05C amended effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 Definitions. *COMAR 10.07.08.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited hospital” means a hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations. (2) “ACEP” means the American College of Emergency Physicians. (3) “Affiliated hospital” means a hospital that operates and provides ancillary and support services to the freestanding medical facility. (4) “Certified medical radiation technologist” means an individual who is certified by the Board of Physicians to practice medical radiation technology in this State. (5) “Credentialing process” means the process by which a hospital: (a) Verifies qualifications of a physician; (b) Delineates clinical privileges of a physician; and (c) Monitors performance of a physician. (6) “Department” means the Maryland Department of Health. (7) “Emergency medical condition” means a medical condition manifesting itself by acute symptoms of sufficient severity including severe pain, psychiatric disturbances, and symptoms of substance abuse such that the absence of immediate medical attention could result in: (a) Placing the health of the individual in serious jeopardy; (b) Placing the health of a pregnant woman or unborn child in serious jeopardy; (c) Serious impairment to any bodily function; (d) Serious dysfunction of any bodily organ or part; or (e) With respect to a pregnant woman who is having contractions: (i) Inadequate time to effect a safe transfer to another hospital before delivery; or (ii) The transfer posing a threat to the health or safety of the woman or the unborn child. (8) “Freestanding medical facility” means a facility: (a) In which medical and health services are provided; (b) That is physically separated from a hospital or hospital grounds; and (c) That is an administrative part of a hospital or related institution. (9) “Hospital” means an institution that: (a) Has a group of at least five physicians who are organized as a medical staff for the institution; (b) Maintains facilities to provide, under the supervision of the medical staff, diagnostic and treatment services for two or more unrelated individuals; and (c) Admits or retains the individuals for overnight care. (10) “Joint Commission on Accreditation of Healthcare Organizations” means the voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97. (11) “License” means a document issued by the Secretary to operate a freestanding emergency medical facility in this State. (12) “Licensed independent practitioner” means any individual permitted by law and by the facility to provide care and services without direction or supervision within the scope of the individual's license and consistent with individually granted clinical privileges. (13) “Physician” means an individual who is licensed by the Board of Physicians to practice medicine in this State. (14) “Registered nurse” means an individual who is licensed by the Board of Nursing to practice registered nursing in this State. (15) “Related institution” means a facility as defined under Health-General Article, §19-301(o), Annotated Code of Maryland. (16) “Secretary” means the Secretary of Health. #### Regulation .02 Incorporation by Reference. *COMAR 10.07.08.02* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) Interhospital Transfer Guidelines Manual; Maryland Institute for Emergency Medical Services Systems, Baltimore, Maryland (January 2002). (2) ACEP Policy Statement: Emergency Department Planning and Resources Guidelines (June 2004), American College of Emergency Physicians, PO Box 619911, Dallas, Texas 75261-9911. (3) Guidelines for Design and Construction of Hospital and Healthcare Facilities, 2001 Edition, American Institute of Architects, 1735 New York Avenue, N.W., Washington D.C. 20006, which is incorporated in COMAR 10.07.01.03. (4) Hospital Accreditation Standards, 2006 Edition, Joint Commission on Accreditation of Healthcare Organizations, One Renaissance Blvd, Oakbrook Terrace, Illinois 60181, which is incorporated in COMAR 10.07.01.09. (5) U.S. Centers for Disease Control and Prevention Guidelines for Standard Precautions and the federal Occupational Safety and Health Administration/Maryland Occupational Safety and Health, Bloodborne Pathogen Standard 29 CFR §1910.1030 which is incorporated by reference in COMAR 09.12.31. (6) The Maryland State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01. #### Regulation .03 Restrictions. *COMAR 10.07.08.03* A freestanding medical facility may not use the name “emergency room”, “emergency department”, or “hospital” in its title or advertisements or on any signage. #### Regulation .04 Licensure Application Procedure. *COMAR 10.07.08.04* A. A hospital may not establish, operate, or continue to operate an existing freestanding medical facility without first obtaining a license from the Secretary. B. A hospital desiring to establish a freestanding medical facility shall apply to the Department for initial licensure on a written or electronic form provided by the Secretary. C. The application shall state the name of the affiliated accredited hospital. D. The application shall be accompanied by a nonrefundable 3-year license fee of $3,000. E. The Secretary shall issue a license to a freestanding medical facility for a term of 3 years if the facility complies with all licensing requirements. #### Regulation .05 Renewal of License. *COMAR 10.07.08.05* A. A licensee shall file an application for license renewal with the Secretary on a written or electronic form provided by the Secretary. B. A licensed freestanding medical facility shall apply for licensure within 60 days of the expiration date of its current license. C. The application fee for license renewal shall be accompanied by a nonrefundable 3-year license renewal fee of $2,000. #### Regulation .06 Inspections. *COMAR 10.07.08.06* A. A freestanding medical facility shall be open to inspection at all times by the Department for annual licensure surveys, revisit surveys, and complaint investigations. B. Licensure Standards. When conducting a licensure or complaint survey, the Department shall use this chapter as well as the: (1) Joint Commission on Accreditation of Healthcare Organization, 2006 Hospital Accreditation Standards; (2) COMAR 10.07.06; (3) COMAR 10.07.01.24, .26 and .33; and (4) ACEP Policy Statement: Emergency Department Planning and Resources Guidelines. C. Responsibility of the Freestanding Medical Facility. The facility shall make the following documents available for review by the Department: (1) Policies and procedures; (2) Minutes of committee meetings; and (3) Data and documentation related to oversight of the freestanding medical facility at the affiliated hospital. #### Regulation .07 Waiver. *COMAR 10.07.08.07* A. Facilities that are providing services on or before February 12, 2007, but do not meet all requirements of this chapter, may request a waiver of specific requirements from the Department. B. All other freestanding medical facilities seeking a waiver from this chapter shall submit a request to the Department including the rationale for the waiver and alternatives to the requirement based on clinical and technical advances. C. In its request, the facility shall demonstrate that a waiver of the requirement would: (1) Not pose a threat to patients or the provision of services; and (2) Be a financial hardship for the facility to comply with that requirement. D. The Department shall review the request for a waiver and notify the freestanding medical facility of its determination. #### Regulation .08 Affiliated Hospitals. *COMAR 10.07.08.08* A. The freestanding medical facility shall be reviewed under the affiliated hospital's accreditation by the Joint Commission on Accreditation of Healthcare Organizations. B. The governing body of the affiliated hospital shall provide administrative and clinical oversight for the care and services provided by the freestanding medical facility. Services of the facility shall be reviewed and monitored consistent with the hospital's bylaws, including but not limited to: (1) Patient safety; (2) Peer review; (3) Medical staff; (4) Risk management; and (5) Quality improvement. C. The Department may issue a waiver for the requirement for accreditation if the affiliated hospital is not accredited or if the hospital is actively seeking accreditation. #### Regulation .09 Treatment of Patients. *COMAR 10.07.08.09* Regardless of a patient's medical condition, insurance status, or ability to pay, the freestanding medical facility shall provide stabilizing treatment to a patient presenting with an emergency medical condition. #### Regulation .10 Personnel. *COMAR 10.07.08.10* A. Administrative Director. The freestanding medical facility shall have a full-time administrative director who: (1) Acts as a liaison with the affiliated hospital; (2) Directs the daily operation of the facility; and (3) Ensures that employees are capable of providing: (a) Resuscitation; (b) Stabilization; (c) Timely triage; and (d) Appropriate transfer of all patients; and (4) Ensures that there is an organized and structured patient safety and quality improvement program to monitor and improve patient care. B. Medical Director. The facility shall have a Medical Director who is: (1) A licensed physician; and (2) Board certified or Board eligible in Emergency Medicine by the: (a) American College of Emergency Physicians; (b) American Board of Emergency Medicine; or (c) American Osteopathic Board of Emergency Medicine. C. The Medical Director shall provide clinical oversight of the freestanding medical facility. D. Other Personnel. The freestanding medical facility shall be staffed at all times with a: (1) Minimum of one physician who is trained in emergency medicine; (2) Sufficient number of registered nurses and other professionals to provide advanced life support; (3) Certified medical radiation technologist; and (4) Laboratory technician. E. A freestanding medical facility shall be staffed during all hours of operation by licensed independent practitioners, nurses, and ancillary health care professionals with the certification, experience, competencies, and skills necessary for providing basic and advanced life support for children and adults. F. Credentialing. Physicians and other licensed independent practitioners shall be credentialed consistent with COMAR 10.07.01.24. G. The facility shall assess its staffing pattern on a regular basis. Staffing patterns shall accommodate the potential for the unexpected arrival of additional patients. The facility shall have a plan for the provision of additional licensed independent practitioners and nurses in times of acute overload. #### Regulation .11 Quality Assurance. *COMAR 10.07.08.11* A. The freestanding medical facility shall develop and implement a quality assurance program. B. The quality assurance program shall have a quality management process that: (1) Is multidisciplinary; (2) Is integrated into the hospital's overall quality management program that is reported to the hospital's governing body; (3) Has a structure to ensure that defined program outcomes and performance measures are developed and monitored regularly; (4) Maintains sufficient documentation to: (a) Verify problems; (b) Identify opportunities for improvement; and (c) Show corrective actions taken and resolution of problems; (5) Includes review of morbidity and mortality; and (6) Evaluates medical care, nursing care, utilization review, tissue review, and pre-hospital care. #### Regulation .12 Laboratory Services. *COMAR 10.07.08.12* A. The freestanding medical facility shall have on-site laboratory services that are available during the facility's hours of operation. B. Laboratory Licensure Standards. The facility's laboratory services shall be licensed consistent with: (1) COMAR 10.10.01; (2) COMAR 10.10.02; (3) COMAR 10.10.03; (4) COMAR 10.10.04; (5) COMAR 10.10.05; (6) COMAR 10.10.06; (7) COMAR 10.10.07; and (8) COMAR 10.10.08. C. Laboratory services shall include the “Suggested Laboratory Capabilities”, ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, Page 13. #### Regulation .13 Radiology Services. *COMAR 10.07.08.13* A. The freestanding medical facility's radiology services shall comply with all State and federal requirements for licensure. B. Radiology services shall be available on site at all times that the facility is open for business consistent with “Radiological, Imaging, and Other Diagnostic Services”, ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, Page 12, except for the sections related to Nuclear Medicine, Radiographic Services, and Vascular/flow Studies including impedance plethysmography. #### Regulation .14 Pharmacy Services. *COMAR 10.07.08.14* A. Pharmacy services for freestanding medical facility patients may be provided by: (1) The facility's affiliated hospital; or (2) A contracted pharmacy. B. The freestanding medical facility that does not have 24-hour a day, 7-day a week outpatient pharmacy services, shall provide its patients with a list of community pharmacies that offer service 24-hours per day. C. The facility's pharmacy services shall be provided and operated consistent with all applicable State and federal laws. D. The freestanding medical facility shall maintain a supply of medications consistent with the “Suggested Pharmacological and Therapeutic Drugs for Emergency Departments”, ACEP Policy Statement Emergency Department Planning and Resources Guidelines, Page 11. E. The facility shall ensure that all drugs and pharmaceuticals are stored securely and maintained within the acceptable level of humidity and temperature. F. Data and other information about quality oversight of the pharmacy services shall be available to the Department for review and monitoring. #### Regulation .15 Access to Emergency Medical Services. *COMAR 10.07.08.15* An emergency medical facility shall meet the requirements of the Maryland Institute for Emergency Medical Services Systems to be eligible to accept patients through the Emergency Medical System. #### Regulation .16 Transfer of Patients. *COMAR 10.07.08.16* A. The freestanding medical facility shall have pre-arranged transfer agreements with facilities that are capable of providing definitive care appropriate for the nature and severity of the patient's illness or injury. B. Patient transfers shall be consistent with the Interhospital Transfer Guidelines published by the Maryland Institute for Emergency Medical Services System. C. When transfer by ambulance is medically necessary the facility shall transfer the patient via: (1) A hospital owned and operated ambulance service; (2) A contracted ambulance service; or (3) An ambulance service through an agreement with the local emergency medical system (EMS) jurisdictional program. D. The level of care and medical interventions provided by an ambulance during transfer shall be appropriate for the patient's condition. E. Before transfer, the patient shall: (1) Be assessed by a physician or licensed independent practitioner; and (2) Receive stabilizing medical treatment consistent with that of the freestanding medical facility's ability to treat. F. The freestanding medical facility shall provide the emergency medical system and the receiving facility with the patient's medical records necessary for ongoing care, including: (1) All treatment provided to the patient; (2) Medications administered to the patient; (3) Diagnostic procedures performed for the patient; and (4) The patient's response to the care at the time of transfer. #### Regulation .17 Medical Records. *COMAR 10.07.08.17* A. The freestanding medical facility shall ensure that staff members develop a legible and appropriate medical record for each patient who visits the facility for treatment. B. Security and Disclosure of Medical Information. The freestanding medical facility shall: (1) Maintain records in a secure manner that protects the confidentiality of patient information at all times; (2) Develop and implement policies and procedures for disclosure of patient medical records and patient access to their medical records, including the costs for retrieving and copying records as defined in Health-General Article, §§4-301— 4-309, Annotated Code of Maryland; and (3) Make medical records available to emergency medical services agencies for outcome data as directed by the Maryland Institute for Emergency Medical Services System. C. Retention. The medical record shall be retained as required by all federal and State laws and regulations and shall be made available promptly to the freestanding medical facility staff. #### Regulation .18 Nourishing Snacks. *COMAR 10.07.08.18* A freestanding medical facility shall maintain a supply of nourishing snacks for patients who may require them. The facility shall provide appropriate storage facilities, including refrigeration for the nourishing snacks. #### Regulation .19 Infection Control. *COMAR 10.07.08.19* The freestanding medical facility shall comply with the U.S. Centers for Disease Control and Prevention guidelines for standard precautions and the federal Occupational Safety and Health Administration/Maryland Occupational Safety and Health, Bloodborne Pathogen Standard, except in a life-threatening emergency in which compliance is not feasible or practicable. #### Regulation .20 Equipment and Supplies. *COMAR 10.07.08.20* The freestanding medical facility shall have equipment and supplies available consistent with the “Suggested Equipment and Supplies for Emergency Departments,” ACEP Policy Statement: Emergency Department Planning and Resources Guidelines, pages 7—10. #### Regulation .21 Physical Environment. *COMAR 10.07.08.21* A. Construction and Zoning. The freestanding medical facility shall comply with the following construction and zoning requirements: (1) All federal, State, and local building, construction and zoning laws; and (2) “Guidelines for Design and Construction of Hospital and Healthcare Facilities, (2001 Edition),” Section 9.6 Freestanding Emergency Facility and other applicable sections. B. Fire Safety. (1) The facility shall comply with the Maryland State Fire Prevention Code and applicable local fire prevention codes that are in effect at the time of plans review and construction. (2) The local fire authority for the proposed facility shall review construction plans and conduct an initial inspection to verify compliance with fire safety requirements before use and occupancy. (3) An annual fire inspection of the facility is required for license renewal. C. Housekeeping. (1) The freestanding medical facility shall be clean and maintained in good repair at all times. (2) The facility shall employ sufficient staff to provide housekeeping and maintenance services, or the services may be provided under a contractual arrangement. (3) The facility shall be maintained in a manner that is safe and free of pests or other hazards. D. Equipment Maintenance. (1) The freestanding medical facility shall have a preventive maintenance program for all facility systems and equipment. (2) The facility shall maintain records of preventive maintenance performed and of all service repairs. (3) Appropriately trained staff employed by the facility or under contractual arrangements shall perform maintenance of clinical equipment. E. All entrances, including ambulance entrances, shall be clearly marked and accessible at all times. F. There shall be a sheltered area for off-loading patients from ambulances. G. The facility shall store and dispose of trash and medical waste consistent with all federal and State laws and regulations. #### Regulation .22 Emergency Preparedness. *COMAR 10.07.08.22* The freestanding medical facility shall develop an emergency preparedness plan to address internal and external emergencies. The emergency plan shall identify the manner by which the facility will interface with local emergency services and the affiliated hospital in the event of a major disaster. #### Regulation .23 Emergency Suspension. *COMAR 10.07.08.23* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action. B. Notice of Emergency Suspension. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the licensee of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. Suspension of License. When a license is suspended by emergency action, the licensee shall: (1) Immediately return the license to the Department; (2) Stop providing services immediately; and (3) Notify patients or the patients' representatives about the suspension and make every reasonable effort to assist them in making other arrangements for services. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing consistent with Regulation .25 this chapter. F. Show Cause Hearing. (1) In addition to the right to request a hearing consistent with Regulation .25 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be given the opportunity for a hearing to show cause why the Department should lift the summary suspension. (2) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension. (3) Show Cause Hearing Procedures. The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who: (a) Shall determine procedural issues; (b) May impose reasonable time limits on each party's oral argument; and (c) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. (4) Results of a Show Cause Hearing. At the conclusion of the show cause hearing, the Secretary or the Secretary's designee may: (a) Affirm the order of summary suspension; (b) Rescind the order of summary suspension; (c) Enter into a consent order; or (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (5) After the show cause hearing, if the Secretary or the Secretary's designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings consistent with Regulation .25 of this chapter. #### Regulation .24 Sanctions. *COMAR 10.07.08.24* A. In addition to other penalties available under State law, the Department may impose sanctions against a freestanding medical facility that fails to comply with Health-General Article, Subtitle 3A, Annotated Code of Maryland, or the regulations of this chapter. The sanctions include: (1) A civil penalty not to exceed $10,000; (2) Restrictions on the operation of the freestanding medical facility; (3) A directed plan of correction; and (4) Suspension or revocation of the freestanding medical facility's license. B. Except as otherwise provided under the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, before the Department may impose any sanctions under §A of this regulation, the Department shall provide the freestanding medical facility notice and an opportunity for a hearing and judicial review under the Administrative Procedure Act. C. Before the Department imposes a directed plan of correction, the Department shall give the freestanding medical facility notice and the opportunity for a prompt informal hearing with the Director of the Office of Health Care Quality. #### Regulation .25 Hearings. *COMAR 10.07.08.25* A. The licensee shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted consistent with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. The Secretary shall issue a final decision consistent with COMAR 10.01.03.35. ### Chapter 09 — Residents' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities **Authority:** Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland **Administrative History:** Effective date: December 30, 1977 (4:27 Md. R. 2107) **Administrative History:** Regulations .01—.03 amended effective December 16, 1985 (12:25 Md. R. 2472) **Administrative History:** Regulation .02K and .03K adopted effective August 30, 1982 (9:17 Md. R. 1708) **Administrative History:** Regulation .03C amended effective August 30, 1982 (9:17 Md. R. 1708) **Administrative History:** Regulations .01—.03 under COMAR 10.07.09 Patients' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities repealed and new Regulations .01—.20 under COMAR 10.07.09 Residents' Bill of Rights: Comprehensive Care Facilities and Extended Care Facilities adopted effective April 22, 1996 (23:8 Md. R. 605) **Administrative History:** Regulation .02B amended effective January 5, 2004 (30:26 Md. R. 1914) **Administrative History:** Regulation .08C amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .09 amended effective January 5, 2004 (30:26 Md. R. 1914) **Administrative History:** Regulation .12A amended effective August 24, 2009 (36:17 Md. R. 1312) #### Regulation .01 Scope. *COMAR 10.07.09.01* The provisions of this chapter apply to a health care facility which is licensed as a comprehensive or extended care facility under COMAR 10.07.02. These facilities are generally known as “nursing facilities”. Failure to comply with the regulations of this chapter is ground for licensure enforcement actions. #### Regulation .02 Definitions. *COMAR 10.07.09.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abuse of a Resident. (a) “Abuse of a resident” means: (i) The nontherapeutic infliction upon a resident of physical pain or injury, for example, striking a resident; or (ii) A persistent course of conduct intended to produce, or resulting in, mental or emotional distress to a resident, for example, verbal intimidation of a resident. (b) “Abuse of a resident” does not mean the performance of an accepted medical procedure ordered by a physician or administered by another licensed health care professional practicing within the scope of the physician's or health care professional's license. (2) “Abuse of funds” means the misappropriation of a resident's assets or income. Misappropriation includes spending the resident's assets or income: (a) Against or without the resident's consent, or, if the resident is incapable of giving consent and has no agent with authority to give consent, when the expenditure is not necessary for the direct and immediate benefit and welfare of the resident; or (b) For the use and benefit of a person other than the resident, if the resident or agent has not consented to the expense. (3) “Agent” means a person who manages, uses, or controls the funds or assets that legally may be used to pay an applicant's or resident's share of costs or other charges for the facility's services. (4) “Certified” means the designation attached to a nursing facility that has met the requirements for participation as a skilled nursing facility in the Medicare Program or as a nursing facility in the Medicaid Program. (4-1) “Change in condition” means a significant change in the resident's physical, mental, or psychological status including, but not limited to: (a) Life-threatening conditions such as heart attack or stroke; (b) Clinical complications such as the: (i) Development of a pressure sore; (ii) Onset or recurrent periods of delirium; (iii) Onset of recurrent urinary tract infection; (iv) Onset of depression; and (v) Onset of aggressive or inappropriate behavior; (c) The need to discontinue a medication or treatment because of: (i) Adverse consequences; or (ii) The need to begin a new form of treatment; (d) Evaluation at or admission to a hospital; or (e) Accidents that result in injury having the potential for requiring a physician's intervention. (5) “Chemical restraint” means use of a psychopharmacologic drug to control behavior and not otherwise required to treat medical symptoms. (6) “Comprehensive care facility” means a nursing facility that admits residents suffering from disease or disabilities or advanced age, who require medical and nursing services rendered by or under the supervision of a registered nurse. (7) “Consent” means an express agreement by a resident who is capable of making an informed decision or, in cases when the resident is not capable, by the resident's representative. (8) “Department” means the Maryland Department of Health. (9) “Director” means the Director of the Office on Aging. (10) “Disabled resident” means a nursing facility resident who lacks sufficient understanding or capacity to make or communicate a responsible or informed decision on health care or personal finances because of a physical or mental disability, or because of substance abuse. (11) “Discharge” means the: (a) Removal of a resident from a nursing facility when the releasing nursing facility is no longer responsible for the resident's care; (b) Movement of a resident from a certified bed to a noncertified bed; (c) Movement of a resident from a skilled nursing facility bed under the Medicare Program to a bed not certified under that Program; or (d) Movement of a resident from a bed certified only for Medicaid to a distinct part of the facility that is a skilled nursing facility under the Medicare Program. (12) “Emergency” means a situation in which the life, health, or safety of an individual is in imminent and serious jeopardy. (13) “Extended care facility” means a nursing facility that: (a) Provides treatment services for residents requiring inpatient care but who do not currently require continuous hospital services; and (b) Admits residents who: (i) Require extensive restorative or rehabilitative services, or (ii) Have a terminal disease requiring extensive nursing care. (14) Involuntary Transfer or Discharge. (a) “Involuntary transfer or discharge” means a transfer or discharge of a resident that is initiated by a nursing facility without the consent of the resident or, when applicable, the resident's representative. (b) “Involuntary discharge” includes a discharge as described in Regulation .12E of this chapter. (15) “Licensee” means a person licensed by the Department to operate a comprehensive care facility or an extended care facility. (16) “Licensing and Certification Administration” means the survey and licensing agency, a unit of the Department of Health. (17) “Neglect” means failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. (18) “Nursing facility” means a comprehensive care or extended care facility. (19) “Office” means the Office on Aging. (20) “Physical restraint” means a device, including material or equipment, attached or adjacent to a resident's body, that the resident cannot remove easily and that restricts the resident's freedom of movement. (21) Private Pay. (a) “Private pay” means a nursing facility's acceptance of payment from a source other than the Medical Assistance Program. (b) “Private pay” includes reimbursement by the Medicare Program or other third-party insurer. (22) Relocation. (a) “Relocation” means the movement of a resident from one room to another within: (i) The same Medicare-certified facility; (ii) A Medicaid-only certified nursing facility; or (iii) A licensed-only nursing facility. (b) “Relocation” does not mean the movement of a resident if the effect of the movement is to move the resident from: (i) The distinct part of the nursing facility that is a skilled nursing facility to a distinct part of the nursing facility that is not a skilled nursing facility; or (ii) A bed that is certified for Medicaid to a distinct part of the nursing facility that is a skilled nursing facility. (23) “Representative” means a person referenced in Regulation .03 of this chapter. (24) “Resident” means an individual who is admitted or remains in residence for overnight care in a nursing facility. (25) “Resident funds” means the assets and income of a resident or nursing home applicant that are under the use, ownership, management, or control of the resident or resident's agent. (26) “Residents' Bill of Rights” means the statement of basic rights of each resident of a nursing facility as set forth in: (a) Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland; (b) Title XIX of the Social Security Act, 42 U.S.C. §1396(5)(c); (c) 42 CFR §483.10 et seq.; and (d) The regulations in this chapter. (27) “Transfer” has the meaning as described in §B(11) of this regulation. #### Regulation .03 Resident's Representative. *COMAR 10.07.09.03* A. A nursing facility or nursing facility's agent shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under the Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney established in compliance with Estates and Trusts Article, §13-601, Annotated Code of Maryland; (6) An individual exercising a resident's rights pursuant to Health-General Article, §19-344(r), Annotated Code of Maryland, but not for purposes of medical care or treatment; (7) A representative payee or other similar fiduciary; (8) An agent as defined in Health-General Article, §19-344(c), Annotated Code of Maryland; or (9) A person if that person was designated by a resident who was not disabled at the time the designation was made and if the resident or representative has provided the nursing facility with documentation of the designation. B. A nursing facility may not recognize the authority of a resident's representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. A facility shall document in the resident's record the name of a representative listed in this regulation, including a copy, when applicable, of the designation. #### Regulation .04 Admission Procedures and Requirements. *COMAR 10.07.09.04* A. At the time of admission of a resident, and whenever information changes during the resident's stay, the nursing facility shall notify the resident and, when applicable, a representative or interested family member, in writing and orally, in a language that is easily understood of all terms of admission including, but not limited to the: (1) Residents' Bill of Rights; (2) Nursing facility's policies and procedures that implement the Residents' Bill of Rights; (3) Rules of resident responsibility; (4) Nursing facility's complaint procedure; (5) Nursing facility's visitation rules; (6) Procedures for obtaining a determination from the Medical Assistance Program of the amount of the resident's funds available to pay for the cost of the resident's care; (7) Procedures for establishing eligibility for Medicaid and for receiving refunds for previous private payments covered by these benefits, including the right to request an assessment under 42 U.S.C. §1396r(5)(c) for the purpose of determining the: (a) Extent of a couple's nonexempt resources at the time of institutionalization; and (b) Amount of a couple's resources to be attributed to the community spouse as the spouse's equitable share of resources which are not considered available for payment toward the cost of the institutionalized spouse's medical care or for determining Medicaid eligibility for the institutionalized spouse; and (8) Resident's rights under State law to formulate advance directives. B. Upon admission of a resident, a nursing facility shall: (1) Document in the resident's clinical record whether the resident has executed an advance directive and, if an advance directive exists, keep a copy of the advance directive in: (a) The resident's clinical record; or (b) A location within the nursing facility which is accessible to appropriate administrative, nursing, and medical personnel on a 24-hour a day basis; (2) Prepare an inventory of all property that the resident is bringing into the nursing facility; (3) Request the resident or representative to identify: (a) Those items with a value of $100 or more; (b) Any damage to an item existing before admission of the resident; and (c) Whether the resident is retaining possession of each item or is entrusting the item to the nursing facility for safekeeping on behalf of the resident; (4) Give to the resident and, when applicable, the resident's representative or interested family member, a copy of the inventory prepared under §B(2) of this regulation; and (5) Advise the resident and, when applicable, a representative or interested family member: (a) Whether the nursing facility has purchased insurance to cover a resident's tangible personal property for loss or damage due to the facility's negligence; and (b) Of the limits of insurance coverage. C. With information provided by the resident or representative, a nursing facility shall periodically update the inventory of the resident's personal property with respect to items having a value of $100 or more. D. Required Notification. A nursing facility shall notify in writing: (1) A resident who is entitled to Medicaid benefits at the time of admission, or when the resident becomes eligible for benefits, of: (a) Items and services that are included in the per diem rate under Medicaid, and for which the resident may not be charged; (b) Other items and services that the nursing facility offers and for which the resident may be charged, and the current range of charges for each item and service; (c) The nursing facility's obligation following admission to notify the resident and, when applicable, the agent or interested family member, of any changes made to the items and services for which the resident may or may not be charged; (d) The fact that the resident may not be required to pay for an item or service not covered by Medicaid unless the: (i) Resident or, when applicable, the agent, knowingly requests the item or service; and (ii) Resident receives the item or service; and (e) The resident's right, within 90 days of receiving an item or service, to request an itemized statement of charges that: (i) Briefly and clearly describes each item or service, the amount charged for it, and the identity of the payer billed for the service; and (ii) Contains a statement in bold and conspicuous print as to when interest may be assessed consistent with Regulation .05B(8) of this chapter; (2) A private-pay resident, or the resident's agent, of: (a) The items and services included in the nursing facility's basic per diem rate; (b) The items and services that are covered by Medicare, and of the amount of any copayments or deductibles; (c) Other services that the nursing facility offers and for which the resident may be charged, and the current range of charges for the services, including but not limited to charges related to a resident's monthly drug regimen review and other non-drug-related pharmacy costs; (d) Whether the costs for supplies used in the performance of a service are included in the service charge and the costs of these supplies, within 24 hours of request, when the costs are not included in the service charge; and (e) The resident's right, within 90 days of receiving an item or service or within 30 days of payment, to request an itemized statement of charges that: (i) Briefly and clearly describes each item or service, the amount charged for it, and the identity of the payer billed for the service; and (ii) Contains a statement in bold and conspicuous print as to when interest may be assessed consistent with Regulation .05B(8) of this chapter; and (3) A resident of changes to be made to the items and services specified in §D(1) and (2) of this regulation, and increases in any fee or charge, or a new fee or charge, or a change in billing procedures, at least 45 days before the increase, new charge, or change becomes effective. E. A nursing facility shall: (1) Give the resident a copy of the statement of items, services, and charges provided by the facility; (2) Provide information regarding services to be rendered by other health care providers, including: (a) The cost to the resident; (b) Transportation arrangements; and (c) Direct or indirect financial interests that the nursing facility has in the provider. #### Regulation .05 Admission Prohibitions. *COMAR 10.07.09.05* A. The acts in §B of this regulation are admission prohibitions. B. A nursing facility may not: (1) Require or solicit, as a condition of admission into the nursing facility, the signature of an individual other than the applicant on the application or contract for admission to the nursing facility, unless the: (a) Applicant is adjudicated disabled in accordance with Estates and Trusts Article, §13-701, Annotated Code of Maryland; or (b) Applicant's physician determines that the applicant is incapable of understanding or exercising the applicant's rights and responsibilities and records, in the applicant's nursing facility record, the specific reasons for the determination; (2) Require an individual, including an agent, to incur personal financial liability by signing the contract, although the nursing facility may require the individual to pay for nursing facility care for the resident to the extent of the resident's available income and assets; (3) Charge, solicit, accept, or receive, in addition to any amount otherwise required to be paid under Medicaid, a gift, money, donation, or other consideration as a precondition of admission or expedited admission to, or continued stay in, the nursing facility; (4) Require residents or applicants to waive their rights to Medicare or Medicaid; (5) Require oral or written assurances that residents or applicants are not eligible for, or will not apply for, Medicare or Medicaid benefits; (6) Charge individuals who are eligible for Medicaid more than the rates established by the Medical Assistance Program for these services; (7) Increase any charge and make the resident liable for the increase until the 46th day after the facility notifies the resident in writing; (8) Impose an interest penalty on charges for items and services provided to a resident until the later of the following: (a) 45 days after the nursing facility mails an itemized statement of charges to the resident or the resident's agent; or (b) 30 days after the end of the period covered by the itemized statement of charges; (9) Condition providing care or otherwise discriminate against a resident based on whether the resident has or has not executed an advance directive; (10) Except for contributions toward cost of care as determined by the Medical Assistance Program, charge a resident who is eligible for Medicaid for services, unless the resident or the resident's agent knowingly has requested and received noncovered services, and the nursing facility: (a) Has given proper notice of the availability and cost of the services to residents; and (b) Does not condition the resident's admission or continued stay on the request for and receipt of additional services; and (11) Solicit, accept, or receive a charitable, religious, or philanthropic contribution from an organization or an individual related to the resident or applicant unless the nursing facility makes clear that the contribution is not a condition of admission to, expedited admission to, or continued stay in the nursing facility. #### Regulation .06 Admission Contract Required. *COMAR 10.07.09.06* A. Before or upon admission, a nursing facility and applicant or, when applicable, the applicant's agent, shall execute an admission contract which has been approved by the Department. B. If the Department has approved a model contract, a nursing facility shall include within its contract, at a minimum, all of the provisions of the model contract. C. The nursing facility shall carefully explain all clauses of the contract and answer all questions that the applicant, the applicant's agent, and any interested family member may have. D. Except as required in §B of this regulation, the applicant and, when applicable, an agent, have the right to delete clauses or sections of the contract with which they do not agree, or to add clauses or sections, subject to the nursing facility's concurrence. Substantive changes require the Department's approval. E. An admission contract shall include a statement regarding the nursing facility's policies if private funds are exhausted during the resident's stay, including, in clear and concise language, any restrictions with respect to the acceptance of third-party payments. F. An admission contract used by a certified Medicaid provider shall clearly state that if private funds are exhausted during the resident's stay, and Medicaid payment is available, the nursing facility shall accept Medicaid payments on behalf of the resident. G. An admission contract used by a certified Medicaid provider shall inform the applicant, through a form established by the Department, that medical eligibility is a requirement for Medical Assistance, and that the applicant should learn if the applicant meets the Medicaid eligibility requirement at the time of admission. #### Regulation .07 Third-Party Signature on Admission Contract. *COMAR 10.07.09.07* A. If a facility requires an individual, other than the applicant or resident, to sign the admission contract, the conditions of Regulation .05B(1) of this chapter shall be met. B. If an agent, as defined in Regulation .02B(3) of this chapter, signs the contract, the agent accepts responsibility to pay for the cost of the resident's care only to the extent of the resident's available funds and assets. C. If an agent, as defined in Regulation .02B(3) of this chapter, signs the contract, the agent is not, by signing the contract, accepting any responsibility for making payments from the agent's own personal funds, unless the agent does so voluntarily. The facility shall list separately in the contract any obligations voluntarily entered into by the agent, and the agent shall initial these obligations on the contract. D. An agent who has not paid a current obligation for the resident's care may apply to the Medical Assistance Program for a determination of the funds available to pay for the cost of the resident's care. E. An agent shall distribute any funds, including income or assets of the applicant or resident that the Medical Assistance Program has determined to be available, to pay for the cost of the resident's care in the facility. F. An agent shall seek, on behalf of the applicant or resident, all assistance from the Medical Assistance Program that may be available to the applicant or resident. G. The Attorney General may impose civil money penalties against an agent who wilfully or with gross negligence violates the requirements of this regulation as follows: (1) An agent who wilfully or with gross negligence violates §E of this regulation is subject to a civil money penalty not less than the amount of funds subject to the violation; and (2) An agent who wilfully or with gross negligence violates §F of this regulation is subject to a civil money penalty not exceeding $10,000. #### Regulation .08 Resident's Rights and Services. *COMAR 10.07.09.08* A. A nursing facility shall provide care for residents in a manner and in an environment that maintains or enhances each resident's dignity and respect, and in full recognition of the resident's individuality. B. A nursing facility may not interfere with a resident's exercise of rights guaranteed under the Constitution or laws of the United States and Maryland. C. A resident has the right to: (1) Reside and receive services in a nursing facility with reasonable accommodations of individual needs and preferences, except when accommodations would endanger the health or safety of the resident or other residents; (2) Receive treatment, care, and services that are in an environment that promotes maintenance or enhancement of each resident's quality of life; (3) A dignified existence, self-determination, and communication with and access to individuals and services inside and outside the nursing facility; (4) Be free of interference, coercion, discrimination, or reprisal from the nursing facility when exercising the resident's rights; (5) Be free from: (a) Physical abuse; (b) Verbal abuse; (c) Sexual abuse; (d) Physical or chemical restraints imposed for purposes of discipline or convenience; (e) Mental abuse; and (f) Involuntary seclusion; (6) Choose an attending physician, if the physician agrees to abide by nursing facility policies and procedures, and the regulations in this chapter; (7) Choose a pharmacy to obtain medications as set forth in COMAR 10.07.02.15B(3) and D(3); (8) Be fully informed in advance about care and treatment, and of proposed changes in that care or treatment; (9) Participate in planning care and treatment, or changes in care or treatment; (10) Seek advice from the resident care advisory committee concerning the options for medical care and treatment for an individual with a life-threatening condition in accordance with Health-General Article, §19-370 et seq., Annotated Code of Maryland; (11) Consent to or refuse treatment, including the right to accept or reject artificially administered sustenance in accordance with State law; (12) Self-administer drugs if the interdisciplinary team determines that the practice is safe; (13) Access the resident's records within 24 hours, excluding weekends and holidays, upon an oral or written request; (14) Purchase copies of all or part of the resident's records upon request by giving 2 working days advance notice to the nursing facility; (15) Approve or refuse the release of personal and clinical records to an individual outside the nursing facility unless: (a) Otherwise provided by Health-General Article, §4-301 et seq., Annotated Code of Maryland; or (b) The release is required by law; (16) Personal privacy, including: (a) Confidentiality of personal records; and (b) Privacy in: (i) Medical treatment, and (ii) Personal care; (17) Privacy in the resident's room, including the right to have nursing facility staff knock before entering the resident's room; (18) Privacy in written communication, including the right to: (a) Send and receive mail promptly without it being opened by anyone other than the resident, except when the resident requests assistance; and (b) Have access to stationery, postage, and writing implements at the resident's own expense; (19) Reasonable access to the private use of a telephone; (20) Meet or visit privately with any individual the resident chooses, subject to reasonable restrictions by the nursing facility on visiting hours and places; (21) Visit or meet privately with the following, to whom the nursing facility shall provide reasonable access: (a) A representative of the Secretary of the U.S. Department of Health and Human Services; (b) A representative of the Department; (c) The resident's personal physician; (d) A representative of the State Long-Term Care Ombudsman Program; (e) The agency responsible for advocacy and protection of developmentally disabled and mentally ill individuals in Maryland; or (f) Any other legal representative; (22) Visit privately with the resident’s spouse or domestic partner; (23) Consent or deny consent to all visits, and may deny or withdraw consent at any time; (24) Examine the results of the most recent federal and State surveys, including the annual survey and any subsequent complaint investigations, not otherwise prohibited by law, of the nursing facility and any plans of correction prompted by these surveys; (25) Receive notice before the resident's roommate is changed and, to the extent possible, have input into the choice of roommate; (26) Voice grievances, including those about treatment or care that is or fails to be furnished, and recommend changes in policies and services, to the staff or administrator of the nursing facility, the Licensing and Certification Administration, the Office on Aging, or any other person, without fear of reprisal, restraint, interference, coercion, or discrimination; (27) Prompt efforts by the nursing facility to resolve grievances the resident may have, including those with respect to the behavior of other residents; (28) Contact and receive information from agencies acting as client advocates; (29) Refuse to perform services for the nursing facility; (30) Perform services for the nursing facility if the resident chooses, only if: (a) The nursing facility has documented the need or desire for work in the plan of care; (b) The plan specifies the nature of the services to be performed and whether the services are voluntary or paid; (c) Compensation for paid services is at or above prevailing rates; and (d) The resident agrees in writing to the work arrangement described in the plan of care, and the contract is part of the resident's record; (31) Share a room with the resident's spouse if both spouses consent and it is not medically contraindicated; and (32) Participate in social, religious, and community activities if the activities do not interfere with the rights of other residents in the nursing facility. D. A resident has the right to participate or refuse to participate in experimental research. When the resident is incapable of making this decision, the resident's appropriate representative may consent for participation in therapeutic experimental research only. E. The resident or, when applicable, the resident's health care representative, has the right to be fully informed, in a language that the resident or representative can reasonably be expected to understand, of complete and current information about the resident's diagnosis, treatment, and prognosis, unless it would be medically inadvisable as documented by the resident's attending health care provider. If this determination has been made, the health care provider shall, upon written request: (1) Make a summary of the undisclosed portion of the medical record available to the resident or health care representative; (2) Insert a copy of the summary in the medical record of the resident; (3) Permit examination and copying of the medical record by another health care provider; and (4) Inform the resident or health care representative of the resident's or health care representative's right to select another health care provider. F. Resident and Family Groups. (1) A resident has the right to organize and participate in resident groups in the nursing facility. (2) A resident's family has the right to meet in the nursing facility with the families of other residents. (3) Staff or other visitors may attend meetings only at the group's invitation. #### Regulation .09 Implementation of Residents' Bill of Rights. *COMAR 10.07.09.09* A nursing facility shall: A. Ensure that: (1) The rights of residents as set forth in the Residents' Bill of Rights are protected, including but not limited to informing each resident of the resident's right to select a physician and pharmacy of the resident's choice; (2) Employees of the nursing facility are trained to: (a) Respect and enforce the Residents' Bill of Rights and the nursing facility's policies and procedures that implement the Residents' Bill of Rights; and (b) Protect the rights of residents; (3) The nursing facility's policies and procedures implement all rights of the residents as set forth in: (a) Health-General Article, §§19-343—19-347 and 19-349—19-352, Annotated Code of Maryland; (b) Title XIX of the Social Security Act; (c) 42 CFR §483.10 et seq.; and (d) The regulations of this chapter; and (4) The nursing facility's policies comply with the requirements of federal and State law concerning advance directives, including but not limited to: (a) If an applicant is incapacitated or is incapable of informing the nursing facility whether the applicant has executed an advance directive, the facility may provide advance directive information to the resident's health care representative; and (b) Once the resident is no longer incapacitated, the facility shall provide the advance directive information to the resident directly at the appropriate time; B. Post conspicuously in a public place accessible to residents: (1) The Residents' Bill of Rights in large, clearly readable type; (2) The nursing facility's complaint procedures in large, clearly readable type; (3) The nursing facility's statement of deficiencies for the most recent survey and any subsequent complaint investigations conducted by federal or State surveyors and any plans of correction in effect with respect to the survey or complaint investigation findings; and (4) Signs provided by the Department to notify the visiting public and residents: (a) That complaints may be made to the Department or to the Office; (b) How to report an instance of abuse of a resident to the Department, the Office, or law enforcement agencies; and (c) How to file a complaint with State agencies and client advocacy agencies, such as the Licensing and Certification Administration, the Office on Aging, the Older Americans Act Legal Services providers, the Maryland Disabilities Law Center, State Medicaid Fraud Unit, and the Legal Aid Bureau, Inc.; C. Establish and maintain identical policies and practices regarding transfer, discharge, and the provision of services under the State plan for all individuals, regardless of source of payment; D. Provide each resident and, if applicable, the resident's appropriate representative or interested family member, with a written description of the resident's legal rights, including a: (1) Description of the manner of protecting resident funds; and (2) Statement that the resident may file a complaint with the Department or the Office concerning resident abuse, neglect, misappropriation of resident property in the nursing facility, and noncompliance with advance directive requirements; E. Place the name, address, and telephone number of the physician who is responsible for the resident's care within easy access of the resident; F. Inform the resident and the appropriate legal representative, or interested family member, and promptly consult with the resident's physician if any of the following incidents occur: (1) An accident involving the resident which results in injury; (2) A significant change in the resident's physical, mental, or psychosocial status; (3) A need to alter treatment significantly; or (4) A decision to transfer or discharge the resident from the nursing facility; G. Consistent with State and federal confidentiality laws and, in a timely manner, notify a resident and, if applicable, the resident's representative or interested family member, of any: (1) Change in condition; (2) Adverse event that may result in a change in condition; (3) Outcome of care that results in an unanticipated consequence; and (4) Corrective action, if any; H. Notify the resident and, when applicable, the appropriate representative, or interested family member, when there is a change in: (1) Room or roommate assignment; (2) The Residents' Bill of Rights; or (3) Federal or State law and regulations relating to residents' rights; I. Record and update the address and phone number of the resident's representatives and interested family members; J. Permit representatives of the State Long-Term Care Ombudsman Program to accomplish their responsibilities, as set forth in 42 U.S.C. §3058g, the State Long-Term Care Ombudsman Program; K. Encourage the activities of resident and family groups by: (1) Providing the residents and their families with private space for meetings; (2) Designating a staff person to provide assistance and respond to written requests from residents and their families; (3) Listening to the views of residents and their families; (4) Acting upon the grievances and recommendations of residents and their families concerning proposed policy and operational decisions affecting resident care and life in the nursing facility; and (5) Advising resident and family groups of the disposition of their grievances and recommendations; L. Educate staff, residents, representatives, and interested family members on advance directives; M. When applicable, promptly provide the Medical Assistance Program with all required information in its possession; and N. Provide copies of clinical records upon request, based on the following charges: (1) A fee for copying and mailing not exceeding 50 cents per page; (2) A discretionary fee not to exceed $15 for record retrieval and preparation; (3) The actual cost of postage and handling of the copies; and (4) A discretionary annual adjustment in the fees described in §M(1)—(3) of this regulation based on the current Consumer Price Index. #### Regulation .10 Resident Transfers and Discharges. *COMAR 10.07.09.10* A. A nursing facility may not involuntarily transfer or discharge a resident from the nursing facility unless the: (1) Transfer or discharge is necessary for the resident's welfare and the resident's needs cannot be met in the nursing facility; (2) Transfer or discharge is appropriate because the resident's health has improved sufficiently so that the resident no longer needs the health care or services provided by the nursing facility; (3) Resident's presence endangers the health or safety of other individuals in the nursing facility; (4) Resident has failed, after reasonable and appropriate notice, to pay, or to have paid under third-party payers, for a stay at the nursing facility; or (5) Nursing facility ceases to operate or, in the case of a resident who receives Medicare or Medicaid services, when the nursing facility has been decertified or has withdrawn from the Medicare or Medicaid Program. B. A resident has a right to request a hearing on the proposed transfer or discharge, except when the transfer or discharge is being taken pursuant to §A(5) of this regulation. C. Notice. (1) Transfer and Discharge. Except in emergency situations such as a hospitalization, or if the resident has not resided in the facility for 30 days, the nursing facility shall notify the resident, representative, or interested family member, the State Long-Term Care Ombudsman, and the Department at least: (a) 30 days before any proposed transfer or discharge if the nursing facility is not part of a continuing care retirement community as defined in Article 70B, Annotated Code of Maryland; or (b) 60 days before any proposed transfer or discharge if the nursing facility is part of a continuing care retirement community. (2) Emergency Transfers, Discharges, and Relocations. In an emergency situation, a nursing facility shall notify the resident, representative, or interested family member of a transfer as soon as possible. D. Contents of Notice. The required notice to a resident under this regulation shall be on a form developed by the Department and shall include: (1) Each reason for the proposed transfer or discharge; (2) A statement that the resident has the right to request a hearing on a proposed transfer or discharge, and how to request a hearing pursuant to Regulation .13 of this chapter, except in the case of a discharge made pursuant to §A(5) of this regulation; (3) The name, address, and telephone number of the State's Office on Aging and local office on aging long-term care ombudsman; (4) The right of a resident to consult with any lawyer the resident chooses; (5) The name, address, and telephone number of the Legal Aid Bureau, The Older American Act Senior Legal Assistance Programs, and other agencies that may provide assistance to individuals who need legal counsel; (6) For nursing facility residents with developmental disabilities, the mailing address and telephone number of the agency responsible for the protection and advocacy of developmentally disabled individuals; (7) For nursing facility residents who are mentally ill, the mailing address and telephone number of the agency responsible for the protection and advocacy of mentally ill individuals; (8) The effective date of the proposed transfer or discharge which, except as set forth in §C of this regulation, is at least 30 days after receiving the notice and at least 60 days after receipt of the notice if the nursing facility is part of a continuing care retirement center; and (9) The resident's rights concerning discharge, as set forth in Regulation .11 of this chapter. E. Documentation. (1) In the event of a discharge or transfer of a resident, a nursing facility shall ensure that the following appears in the resident record: (a) The circumstances surrounding the discharge or transfer, including interventions initiated by the facility before proposing the discharge; (b) The notice described in §§C and D of this regulation; and (c) If applicable, any express consent given by the resident or, when applicable, the resident's representative. (2) When a resident is transferred or discharged pursuant to §A(1) and (2) of this regulation, the resident's physician shall document in the resident's clinical records the reason or reasons why the transfer or discharge is necessary. (3) When a resident is transferred or discharged pursuant to §A(3) of this regulation, a physician shall document in the resident's clinical records the reason or reasons why the transfer or discharge is necessary. #### Regulation .11 Involuntary Discharge or Transfer of a Resident. *COMAR 10.07.09.11* A. In addition to the provisions of Regulation .10 of this chapter, a facility may not involuntarily discharge or transfer a resident unless, within 48 hours before the discharge or transfer, the facility has: (1) Provided or obtained: (a) A comprehensive medical assessment and evaluation of the resident, including a physical examination, that is documented in the resident's medical record; (b) A post-discharge plan of care for the resident that is developed, if possible, with the participation of the resident's representative; and (c) Written documentation from the resident's attending physician indicating that the transfer or discharge is in accordance with the post-discharge plan of care and is not contraindicated by the resident's medical condition; and (2) Provided information to the resident concerning the resident's rights to make decisions concerning health care, including the right to: (a) Accept or refuse medical treatment; (b) Make an advance directive, including the right to make a living will and the right to appoint an agent to make health care decisions; and (c) Revoke an advance directive. B. With the exception of residents of a certified continuing care facility as set forth in §D of this regulation, at the time of transfer or discharge, the facility shall provide the resident and, when appropriate, the representative or interested family member with: (1) A written statement of the medical assessment and evaluation and post-discharge plan of care required under §A of this regulation; (2) A written statement itemizing the medications currently being taken by the resident; (3) To the extent permitted under federal and State law, at least a 3-day supply of the medications currently being taken by the resident; (4) Information necessary to assist the resident or the resident's representative in obtaining additional prescriptions for necessary medication through consultation with the resident's attending physician; and (5) A written statement containing the date, time, method, mode, and destination of the resident's discharge. C. A facility may not discharge or transfer a resident: (1) Unless the resident or appropriate representative consented in writing to the discharge or transfer; or (2) Except when the discharge or transfer: (a) Is in accordance with a post-discharge plan of care developed under §A of this regulation; (b) Is to a safe and secure environment where the resident will be under the care of a: (i) Licensed, certified, or registered care provider; or (ii) Person who has agreed in writing to provide a safe and secure environment. D. A continuing care facility certified under Article 70B, Annotated Code of Maryland, is not subject to §B of this regulation if the: (1) Facility transfers a resident to a lesser level of care within the same facility in accordance with a contract between the facility and the resident; and (2) Transfer is approved by the resident's attending physician. E. If the requirements of §§A—D of this regulation have been met, the resident's representative, in conjunction with the facility, shall cooperate and assist in the resident's discharge planning, including: (1) Contacting, cooperating with, and assisting other health care facilities considering admitting the resident; and (2) Cooperating with government agencies, including applying for Medical Assistance for the resident. F. If requested by a person during the process of transferring or discharging a resident, or on its own initiative, the Office of the Attorney General may investigate whether an abuse of a resident's funds contributed to the decision to transfer or discharge the resident, and may make appropriate referrals of the matter to other government agencies. G. The Secretary may impose a civil money penalty not to exceed $10,000 for each: (1) Violation by a facility of its obligations under this regulation and Regulation .10 of this chapter; or (2) Willfully or grossly negligent violation by a resident's representative of the representative's obligations under this regulation and Regulation .10 of this chapter. H. If a civil money penalty is imposed under §G of this regulation, the facility or representative has the right to request a hearing on the proposed civil money penalty in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.04. I. A resident, resident's representative, resident's attorney, or the Attorney General, on behalf of a resident who believes that an involuntary discharge or transfer that violates this regulation is imminent or has taken place, may request appropriate injunctive relief from the appropriate circuit court. #### Regulation .12 Resident Relocation and Bed Hold. *COMAR 10.07.09.12* A. Notification of Resident Relocation Within a Facility. (1) Except in emergency situations or when it is documented in the resident's record that a resident's physical, clinical, or psychological well-being would be jeopardized, a nursing facility shall notify a resident or, when applicable, the resident's representative or interested family member, if available, in writing at least 30 days before the resident is relocated within a facility or to a different part of a facility, unless the resident or, if the resident is incapacitated, the resident's legally authorized representative, agrees to the relocation and this is documented in the resident's record. (2) Under the limited conditions set forth in §A(1) of this regulation where 30-days notice cannot be provided in advance of a relocation, the facility shall document that it has provided notice of the relocation as soon as practicable. (3) When a resident is relocated, the facility shall elicit and make reasonable efforts to comply with the resident's request of location and, if applicable, assignment of roommate. B. A resident's right to refuse a change in room assignment under §A of this regulation does not affect the resident's eligibility or entitlement to Medicaid benefits. C. Notice. (1) Notice of Bed-Hold Policy at the Time of Admission. At the time of admission, a nursing facility shall provide written information to a resident or, when applicable, the resident's representative or interested family member, describing the facility's bed-hold policy, including the period of time during which the resident is permitted to return and resume residence in the nursing facility. (2) Notice of Bed-Hold Policy at Time of Transfer. At the time of transfer of a resident to a hospital or for therapeutic leave, a nursing facility shall provide a written notice to the resident, or when applicable, the resident's representative or interested family member, which specifies the duration of the bed-hold policy described in §C of this regulation. D. Permitting a Resident to Return to the Nursing Facility. When a resident's hospitalization or therapeutic leave exceeds the bed-hold period under the State Medicaid plan, the resident has a right to be readmitted to the nursing facility immediately upon the first availability of a bed in a semiprivate room if the resident: (1) Requires the services provided by the nursing facility; and (2) Is eligible for Medicaid coverage for the nursing facility's services. E. Unless the bed hold has expired, for purposes of this regulation, transfer includes the refusal of a nursing facility to accept the return of a resident who was previously transferred from the nursing facility: (1) Whose bed at the nursing facility was continuously reserved or required to be reserved through payment to the nursing facility from any source; or (2) Who had an application for medical assistance pending at the time of the transfer if there is no reason to believe that the application will not be approved. F. Transfer and Discharge Planning. In addition to the requirements of Regulation .11 of this chapter, a nursing facility shall provide, in all cases, orientation and planning to residents to ensure safe and orderly transfer of discharge from the nursing facility. #### Regulation .13 Hearings for Transfers and Discharges, and Establishment of an Escrow Account. *COMAR 10.07.09.13* A. A resident may request a hearing within 30 days of receiving a notice of an intended involuntary transfer or discharge as provided in Regulation .10C of this chapter. B. Except in an emergency or when the resident has resided in a facility for less than 30 days, after a request for a hearing has been filed, a nursing facility may not discharge or transfer the resident until: (1) A final decision is issued after the hearing and all requirements of Regulation .11 of this chapter are met; or (2) The resident consents to the discharge or transfer and withdraws the request for a hearing. C. Procedure. (1) The resident shall send a written request for a hearing to the Office of Administrative Hearings by the 30th calendar day after the resident receives the nursing facility's notice of the proposed transfer or discharge. (2) After receiving the written request, the Office of Administrative Hearings shall schedule a hearing. (3) The Office of Administrative Hearings shall conduct the hearing in accordance with COMAR 10.01.04 and 28.02.01. (4) The Department is not a party to a hearing conducted pursuant to this regulation. The parties are the nursing facility and the resident. Therefore, a hearing conducted pursuant to this regulation is not a contested case as defined in the Administrative Procedure Act, State Government Article, §10-202, Annotated Code of Maryland. D. A facility may require that an escrow account be established when the: (1) Basis for a resident's discharge is nonpayment; and (2) Resident continues to reside in the facility pending a final decision. E. If an escrow account is required under §D of this regulation, the facility shall develop a policy and procedure that is acceptable to the Department concerning the establishment and disposition of funds from the escrow account. #### Regulation .14 Physical and Chemical Restraints. *COMAR 10.07.09.14* A. Physical restraints may be used only: (1) As an integral part of an individual medical treatment plan; (2) If absolutely necessary to protect the resident or others from injury; (3) If prescribed by a physician or administered by another health care professional practicing within the scope of their license; and (4) If less restrictive alternatives were considered and appropriately ruled out by the physician. B. Use of Physical Restraints. (1) When a facility uses physical restraints, personnel: (a) Trained in the use of restraints shall check a resident in restraint at least every 2 hours, and maintain a record of the checks and usage; and (b) Shall provide opportunities for motion and exercise during each 2-hour period in which physical restraint is used, and shall monitor the use of the restraint use and maintain a record of it. (2) The attending physician shall ensure that treatment plans include provisions for the progressive elimination of physical restraints. C. Use of Psychopharmacologic Drugs. When a physician prescribes psychopharmacologic drugs for a resident, the resident's clinical records shall contain all of the following documentation: (1) A physician's indication that the dosage, duration, indication, and monitoring are clinically appropriate and the reasons why they are clinically appropriate; (2) Indication that the resident is being monitored for adverse complications of the drug therapy; (3) Confirmation that previous attempts at dosage reduction have been unsuccessful, if applicable; (4) Evidence of the resident's subjective or objective improvement, or maintenance or function, while taking the medication; (5) Evidence that the resident's decline or deterioration, if applicable, has been evaluated by the interdisciplinary team to determine whether a particular drug, a particular dosage, or duration of therapy may be the cause; (6) Evidence of why the resident's age, weight, or other factors would require a unique drug dose, drug duration, indication, or monitoring; or (7) Other evidence that substantiates the use of the restraint. #### Regulation .15 Abuse of Residents. *COMAR 10.07.09.15* A. A nursing facility shall develop and implement policies and procedures prohibiting abuse and neglect of residents. B. A nursing facility may not knowingly employ an individual who has been convicted of abusing or neglecting a resident or who has had a finding entered into the State Nurse Aide Registry concerning abuse or neglect of a resident or misappropriation of a resident's property. C. Reports of Abuse. (1) A person who believes that a resident has been abused shall promptly report the alleged abuse to the: (a) Appropriate law enforcement agency; (b) Licensing and Certification Administration within the Department; or (c) The Office on Aging. (2) An employee of a nursing facility who believes that a resident has been abused: (a) Shall report the alleged abuse as set forth in §C(1) of this regulation within 3 days after learning of the alleged abuse; (b) May be subject to a penalty imposed by the Secretary of up to $1,000 for failing to report an alleged abuse within 3 days after learning of the alleged abuse. (3) An individual on whom a penalty has been imposed may request a hearing on the penalty by submitting a written request for a hearing to the Department on or before the 30th calendar day after the individual received notice of the imposition of the penalty. (4) Upon receiving a request for a hearing under this section, the Secretary shall conduct a hearing in accordance with COMAR 10.01.03. D. Investigations. A nursing facility shall: (1) Thoroughly investigate all allegations of abuse; and (2) Take appropriate action to prevent further incidents of abuse while the investigation is in progress, and after that. E. Immunity from Civil Liability. An individual who, acting in good faith, makes a report under this regulation has immunity from liability described in Health-General Article, §19-347(g), Annotated Code of Maryland. #### Regulation .16 Complaint Procedure. *COMAR 10.07.09.16* A. A resident, the resident's representative, or an interested individual has the right to: (1) Make a complaint about the nursing facility; (2) Recommend a change in facility policy and procedure; and (3) Be free from reprisal, restraint, interference, coercion, or discrimination by the nursing facility or its employees as a result of making a complaint or recommending a change in policy. B. A nursing facility shall develop and implement the following complaint procedures: (1) A resident, the resident's representative, or an interested individual may present complaints to: (a) The nursing facility administration; (b) The nursing facility's staff; (c) The Office; (d) The Department; or (e) Other persons or groups; (2) A complaint may be made to the nursing facility in person, orally or in writing, by telephone or by mail, and may be reported anonymously; (3) A nursing facility may not require the signature of the resident or, when applicable, the resident's representative or an interested individual on a complaint; (4) If a complaint is presented to a nursing facility, the nursing facility shall investigate within 30 days the allegations made in the complaint and advise the complainant of the action the nursing facility is taking to resolve the complaint; (5) A nursing facility shall send to the Office and the Department a copy of any complaint that a complainant indicates has not been resolved to the satisfaction of the complainant; (6) A nursing facility shall maintain a permanent record for inspection by the Office or the Department of all complaints concerning the nursing facility; and (7) A complainant may request a hearing from the Department within 30 days of receiving the facility's response to the complaint or within 60 days of filing the complaint, whichever is earlier. C. A complaint which has not been resolved to the satisfaction of the complainant may be resolved through a hearing as follows: (1) After receiving a written request for a hearing, the Department shall forward a copy of the request to the Office and schedule a hearing; (2) The nursing facility may be represented by the nursing facility administrator, designee, or counsel; (3) The complainant may be represented by: (a) The complainant; (b) The Office; (c) Counsel; or (d) Any other individual; (4) The Department's Director of Licensing and Certification, or a designee of the Director, shall conduct the hearing; (5) The Director or the Director's designee may: (a) Receive testimony from both parties; (b) If appropriate, issue deficiencies and require the nursing facility to submit a plan of correction; (c) Attempt to assist the parties in reaching a satisfactory resolution; (d) Notify the complainant of the results of the findings and any actions taken; and (e) Notify the appropriate State's attorney if there is evidence of criminal conduct. D. A hearing conducted under §C of this regulation is not a contested case as defined in State Government Article, §10-202, Annotated Code of Maryland. #### Regulation .17 Personal Property of Residents. *COMAR 10.07.09.17* A. Personal Possessions. (1) A resident has the right to retain and use personal possessions, including furnishings and appropriate clothing as space permits, unless to do so would be detrimental to the rights or health and safety of other residents. (2) A facility shall take reasonable steps to ensure the safety and security of the personal belongings of its residents. (3) A facility shall provide a reasonable amount of locked storage space for personal property upon the request of a resident. B. A nursing facility may not limit the amount of funds it keeps on behalf of a resident, but may limit the amount of other property that it retains on behalf of the resident. C. A nursing facility shall establish written procedures to prevent loss or damage to, and protect, property. D. A nursing facility shall establish written procedures for investigating an incident of loss or damage to the property of a resident, including: (1) A procedure by which an individual, including a resident or representative of a resident, may report loss or damage; (2) The designation of an employee of the nursing facility to: (a) Receive reports of loss or damage; (b) Conduct an investigation; and (c) Inform the resident, or when applicable, a representative or interested family member, of the results of the investigation. E. Release of Personal Property. A nursing facility shall release the property of a resident to: (1) The resident or a representative upon the: (a) Request of the resident; or (b) Transfer or discharge of the resident from the nursing facility; or (2) A government agency acting pursuant to legal authority. F. Disposition of Personal Property Upon the Death of a Resident. (1) Immediately upon but not later than 30 business days after the death of a resident, a nursing facility shall provide notice of the resident's property being held by the facility to: (a) The resident's representative or interested family member; and (b) Government agencies which have paid any part of the nursing facility charges for the resident. (2) Upon the death of a resident, the nursing facility shall release: (a) The resident's wearing apparel other than furs and jewels to a representative or immediate family member; and (b) Other personal property only to an individual who presents certified letters of administration that designate the individual as “Representative of the Estate of _______________________________________________”. (3) Personal property or income derived from the cash conversion of personal property that a facility holds for a discharged or deceased resident is presumed abandoned in accordance with Commercial Law Article, Title 17, Annotated Code of Maryland, when the property or income from cash conversion is not claimed within 1 year. (4) When a nursing facility is still holding a resident's personal property 1 year after the resident's death, the nursing facility shall notify the Unclaimed Property Section, Comptroller of the Treasury, for appropriate direction. #### Regulation .18 Protection of a Resident's Personal Funds. *COMAR 10.07.09.18* A. A resident has the right to: (1) Manage the resident's financial affairs; or (2) Choose any person who is willing to handle the resident's financial affairs. B. Except as authorized by being appointed representative payee, a nursing facility may not manage a resident's funds without an express written request from: (1) The resident; or (2) An agent who has legal authority to make decisions regarding the resident's funds. C. Management of Personal Funds. Upon written authorization of a resident or agent, a nursing facility shall hold, safeguard, manage, and account for the resident's personal funds that are deposited with the nursing facility as specified in this regulation. D. Personal Funds in Excess of $50. A nursing facility shall: (1) Deposit a resident's personal funds in excess of $50 in an interest-bearing account that is: (a) Established and maintained by the facility under one of the following terms: (i) In the name of the resident only; (ii) In the name of the facility “in trust for” or as the “trustee” for the individual resident; or (iii) In a residents' pooled account, with a separate accounting for each resident's share; and (b) Located in a financial institution whose accounts are insured by the: (i) Federal Deposit Insurance Corporation (FDIC); (ii) Federal Savings and Loan Insurance Corporation (FSLIC); or (iii) Other insurer approved by the Department; and (c) Separate from any of the nursing facility's operating accounts; and (2) Credit all interest earned to the resident's account at least quarterly. E. Personal Funds Less Than $50. A nursing facility may maintain a resident's personal funds that do not exceed $50 in a petty cash fund or a non-interest-bearing account that is identified as a residents' account. F. Establishment of Resident Accounts. When a nursing facility manages a resident's financial affairs, the nursing facility shall establish and maintain a system that: (1) Ensures a full, complete, and separate accounting, according to generally accepted accounting principles, of each resident's personal funds entrusted to the nursing facility; and (2) Precludes any commingling of resident funds with the nursing facility funds. G. For all resident funds entrusted to a nursing facility, the facility shall: (1) Establish and maintain adequate fire and theft coverage to protect a resident's funds that are on the premises of the nursing facility; and (2) Otherwise ensure the security of all residents' personal funds deposited with the nursing facility by purchasing a surety bond with the State as obligee on behalf of the nursing facility residents. H. Limitation on Charges to Personal Funds. A nursing facility may not: (1) Impose a charge against a resident's personal funds for: (a) An item or service for which payment is made under Medicare or Medicaid; and (b) A cost or fee incurred by the facility for establishing and servicing the resident's accounts; or (2) Use a Medicaid resident's personal funds to offset a contribution of care debt unless authorized by the resident, the resident's agent, or a court. #### Regulation .19 Records of Resident Personal Funds. *COMAR 10.07.09.19* A. Records. For all resident funds entrusted to a nursing facility, the facility shall: (1) Maintain an individual record for the funds of each resident, which includes the following information regarding each fund transaction: (a) The date of the transaction; (b) The type of transaction, whether it is a deposit, withdrawal, or any other transaction; (c) When the transaction is a withdrawal or deposit, reference to a numbered receipt; and (d) The balance of funds after the completion of the transaction; (2) At least weekly, post to the record of the funds all deposits, withdrawals, and other transactions; (3) Furnish each resident or, when applicable, the resident's agent or interested family member, with a quarterly statement of the resident's individual account not later than 30 days after the end of each quarter; (4) Make available for inspection by the resident or, when applicable, the resident's agent or interested family member, a monthly statement of the resident's account; and (5) Make available at the nursing facility, for audit by the Department and the Office, records pertaining to each resident's funds. B. Receipts of Transactions. (1) If a transaction involves a transfer of funds between a resident and a second party, or between the nursing facility and the institution in which the resident's account is located, the nursing facility or financial institution shall: (a) Provide a receipt or copy of a receipt to the resident, or retain the resident's copy of the receipt as part of the resident's individual financial record; and (b) Maintain the original receipt and make it available for audit. (2) Except as provided in §B(3) of this regulation, a nursing facility shall require that each receipt for withdrawal of funds from a resident's account be signed by the resident or, when applicable, the resident's agent. (3) A nursing facility may allow a resident to withdraw money from the resident's account without signing a receipt only if the nursing facility documents that the resident is not disabled but is incapable of signing due to a physical disability. (4) Except as set forth in Regulation .18H(2) of this chapter, a nursing facility may withdraw money from a resident's account without written authorization of the resident or, when applicable, the resident's agent, if the: (a) Nursing facility documents that the resident is incapable of understanding the resident's rights and responsibilities regarding finances; (b) Resident's agent is unavailable; and (c) Withdrawal of funds is for an item or service needed for the resident's direct and immediate benefit and the facility maintains documentation that the withdrawal was used for that purpose. (5) A withdrawal under §B(4) of this regulation requires witness signatures of two facility employees authorized by the facility administrator. C. Availability of Funds. (1) A resident has the right to access funds entrusted to the nursing facility: (a) During normal business hours, if the funds are held within the facility; or (b) Within 3 banking days, if a bank, the State treasurer, or a county or municipal treasurer holds the money. (2) When a nursing facility transfers or discharges a resident, the nursing facility shall either: (a) Request and follow the resident's written instructions for transferring the money; (b) Return, upon the resident's or, when applicable, the resident's agent's demand, the resident's money that the nursing facility has in its possession and have the resident or agent sign a receipt for the money; or (c) Make available to the resident or the resident's agent, within 3 banking days, the resident's money which is in an account with a bank, the State treasurer, or county or municipal treasurer. D. Notice of Balances. A nursing facility shall provide written notification to a resident who receives Medicaid benefits: (1) As specified in §1611(a)(3)(B) of the Social Security Act when the amount in the resident's account reaches $200 less than the Supplemental Security Income (SSI) resource limit for one individual; and (2) That, when the amount in the account, in addition to the value of the resident's other nonexempt resources, reaches the SSI resource limit for one individual, the resident may lose eligibility for Medicaid or SSI. E. Death of a Resident. Upon the death of a resident for whom a nursing facility is holding funds, the nursing facility shall notify the resident's agent or interested family member and: (1) Convey within 30 days a final accounting of the resident's personal funds which are deposited with the nursing facility; (2) Transfer, pursuant to the resident's preexisting burial contract, an amount not to exceed the outstanding unpaid balance of the contract, or the total of the resident's funds entrusted to the nursing facility, whichever is less; (3) Release the resident's funds only to an individual who presents certified letters of administration that designate the person as “Representative of the Estate of _______________________________________”; and (4) When the nursing facility is still in possession of a resident's funds 1 year after the resident's death, the facility shall report all money it holds for the former resident to the Unclaimed Property Section, Comptroller of the Treasury. #### Regulation .20 Misuse of Resident's Funds. *COMAR 10.07.09.20* A. A person may not misappropriate a resident's assets or income, including spending the resident's assets or income against or without the resident or resident's agent's consent, except as permitted by Regulation .19B(4) of this chapter. B. A person who believes that there has been an abuse of a resident's funds may make a complaint to the: (1) Local department of social services; (2) Director of the Office on Aging if the resident is 65 years old or older; or (3) Director of the Licensing and Certification Administration, regardless of the resident's age. ### Chapter 10 — Home Health Agencies **Authority:** Health-General Article, §19-404, Annotated Code of Maryland **Administrative History:** Effective date: June 2, 1978 (5:11 Md. R. 884) **Administrative History:** Regulation .03B amended effective June 29, 1979 (6:13 Md. R. 1126); June 13, 1980 (7:12 Md. R. 1147); May 24, 1982 (9:10 Md. R. 1022) **Administrative History:** Regulation .09E amended effective May 24, 1982 (9:10 Md. R. 1022) **Administrative History:** Chapter revised effective December 14, 1987 (14:25 Md. R. 2660) **Administrative History:** Regulation .02B amended effective April 11, 1994 (21:7 Md. R. 530) **Administrative History:** Regulation .04 amended effective April 11, 1994 (21:7 Md. R. 530) **Administrative History:** Regulation .04B amended effective May 1, 1989 (16:8 Md. R. 909); August 19, 1991 (18:16 Md. R. 1811) **Administrative History:** Chapter revised effective June 6, 2016 (43:11 Md. R. 634) **Administrative History:** Regulation .04B, C amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Purpose. *COMAR 10.07.10.01* The purpose of these regulations is: A. To promote the interests and general well-being of all patients of home health agencies providing service within the State; B. To protect those interests by a public declaration of support for a patient's bill of rights; and C. To assure that the treatment of patients is, at all times, fully consistent with the provisions of this Act. #### Regulation .02 Definitions. *COMAR 10.07.10.02* A. All terms used in these regulations shall have the same meaning as those used in the Act. B. Terms Defined. (1) “Administrator” means an individual who has had: (a) Formal education in health services or administration, as evidenced by being a: (i) Physician, (ii) Registered nurse, or (iii) College graduate with a bachelor's or higher degree in a health-related field; and (b) At least 1 year of supervisory experience in: (i) Hospital management, (ii) Home health management, or (iii) Public health program management. (2) “Clinical note” means a dated and signed notation, with service designation by a member of the health team, of a contact with a patient. (3) “Clinical record” means a written account of all services provided a patient within the authorities of the home health agency, as well as other pertinent information necessary to provide care. (4) “Consumer” means a resident of the geographic area served who has demonstrated an interest in health care. The consumer representative may not personally, or through direct family ties, have any financial or active professional interest in the operation of the agency and shall be free of the existence of or appearance of conflict of interest. (5) “Department” means the Maryland Department of Health. (6) “Governing authority” means the individual, partnership, agency, group, or corporation designated to assume full legal responsibility for the policy determination, management, operation, and financial liability of the home health agency. (7) “Home health agency” means a health-related institution, organization, or a part of an institution that: (a) Is owned or operated by one or more persons, whether or not for profit and whether as a public or private enterprise; and (b) Directly or through a contractual arrangement, provides to a sick or disabled individual in the residence of that individual skilled nursing services, home health aid services, and at least one other home health care service, that are centrally administered. (8) “Home health aide” means a nonlicensed person who: (a) Has: (i) At least 1 year of practical experience in a hospital, nursing home, home care program; or (ii) Satisfactorily completed the Maryland Red Cross Home Care Course or an equivalent program; and (b) Provides personal and health care services to an individual in the place of residence, under supervision of the appropriate health professional. (9) “In-home service” means a program provided by a home health agency which makes available personal care, homemaker, chore, or respite services to disabled or elderly persons in the place of residence. The services are designed to enable these persons to remain in their own residence consistent with their desires, abilities, and safety. (10) “Maintenance health care” means a program provided by a home health agency for patients who are medically stable or have attained a satisfactory level of rehabilitation. These patients require only periodic monitoring by a health care professional in order to maintain their health care status and do not require the renewal of physician orders at least every 60 days. (11) “Parent agency” means the agency that develops and maintains administrative and professional control of the delivery of services either directly or through branch offices. (12) “Physician” means a person who is currently authorized to practice medicine under Health Occupations Article, §1-101, Annotated Code of Maryland. (13) “Professional advisory group” means a committee which includes: (a) One currently licensed physician; (b) One registered nurse; (c) One representative providing input from each allied discipline utilized by the agency; and (d) One consumer representative. (14) “Progress note” means a dated written notation by a member of the health team summarizing facts about the care given and the patient's response during a given period of time. (15) “Secretary” means the Secretary of Health. (16) “Skilled care” means a service or services which can only be safely and effectively provided by a person licensed under Health Occupations Article, Annotated Code of Maryland, and exercising specialized knowledge, judgment, and skill. (17) “Skilled nursing services” means services provided by or under the supervision of a registered nurse and in accordance with the plan of treatment. (18) “Utilization review” means a medical record review procedure designed to evaluate: (a) The appropriateness of admissions; (b) The efficiency and adequacy of provided services; and (c) Length of stay and discharge practices. #### Regulation .03 Application for a License. *COMAR 10.07.10.03* A. The applicant shall file an application for a license to operate a home health agency on forms provided by the Department. B. The application for licensure shall contain the name and address of each officer and director of the home health agency. Those corporations having more than 100 owners shall name those having an interest of 2 percent or more. Persons related by marriage or blood to the third degree of consanguinity shall each be named if the sum of their separate holdings exceeds 2 percent. #### Regulation .04 General Licensure Provisions. *COMAR 10.07.10.04* A. A person, partnership, corporation, or association, or any State or local government or agency thereof, may not conduct, operate, or maintain a home health agency in the State without being licensed by the Department. A license is valid for 1 year from the date of issuance, unless revoked by the Secretary. B. Application for License. An agency desiring to conduct, operate, or maintain a home health agency in the State shall file an application with the Secretary, on a written or electronic form provided by the Secretary. C. Renewal of License. An agency shall file an application on the written or electronic form provided by the Secretary for renewal of the license at least 60 days before expiration of the issued license and submit it on forms provided by the Secretary. D. The home health agency shall: (1) Demonstrate compliance with all applicable federal, State, and local laws and regulations, including the requirement of Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. (2) Provide liability insurance to cover all employees. The agency shall also ensure that its contractual persons possess appropriate liability protection. (3) Maintain records as determined by the Department and make the records available to the Department upon request. (4) Accept patients for skilled care only on the signed order of a physician, obtained within 28 days after acceptance. (5) Contact a physician to obtain a signed order as soon as possible, but not later than 10 days after acceptance of a patient for skilled care, and record all efforts to contact the physician. (6) Adopt procedures for the administration of drugs and biologicals which shall include: (a) The administration of treatment modalities, including any intravenous procedures, chemotherapy, parenteral feedings, and injections; (b) The assurance of 24-hour-a-day availability of care for the hours during the administration of intravenous medications and nutritional support; (c) The administration of drugs and treatments only by the following licensed agency staff: (i) Physician, (ii) Registered nurse, or (iii) Licensed practical nurse if the drugs or treatments are administered under the supervision of a registered nurse in accordance with the physician's plan of treatment, and in accordance with a plan of care developed by a registered nurse; (d) Minimum training in keeping with applicable law for staff who administer drugs and treatments; (e) Drugs and treatments to be administered only as ordered by the physician; (f) Documentation in the patient's medical record of medications administered and any medication errors, adverse drug reactions, and corrective actions; (g) If the agency provides to any patient controlled drugs as described in Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland, written policies and procedures governing the disposal of controlled drugs in accordance with applicable federal and State laws and regulations. (7) Have services available at least 8 hours a day, 5 days a week, and available on an emergency basis 24 hours a day, 7 days a week by: (a) Establishing a procedure by which any patient may contact a representative of the agency at any time by telephone; (b) Ensuring that the person receiving patient calls is able to contact a registered nurse immediately, but not later than 1/2 hour after receipt of a patient's call; and (c) Ensuring that the registered nurse: (i) Assesses the patient's needs; and (ii) In emergency situations, renders immediate care to the patient, or causes the patient to be treated by an appropriate health care provider. E. The Department shall: (1) Issue its operating license only to the home health agency named in the application. The license may not be transferred or reassigned. The license shall be immediately void if the home health agency ceases to operate and shall be returned to the Department. (2) Issue licenses which expire 1 year from the date of its issuance or, in the case of a provisional license, on the date specified at the time of issuance, unless otherwise revoked or suspended by the Department. (3) Make inspections and surveys at least annually to determine compliance with the regulations. (4) Conduct its inspections, surveys, and investigations at all reasonable times and at all geographical locations considered necessary for the proper conduct of its business. (5) Prepare a written report detailing its determination of compliance with those regulations. A copy of this report shall be forwarded to the applicant within 30 days of the inspection. F. If a parent agency is located outside the State, the Department shall issue a license if: (1) At least one branch office is located within the State; or (2) The parent agency is located in a state bordering Maryland and either the: (a) Bordering state has a reciprocal agreement for home health licensure, under which the agency may be inspected at the discretion of the Department; or (b) Agency agrees to be inspected by the Department. G. Investigation of complaints shall be conducted by the Department as necessary. #### Regulation .05 Inspections. *COMAR 10.07.10.05* A licensed home health agency or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving residents, for inspection by the Department or by any other agency designated by the Department to: A. Survey home health agencies at least every 3 years; B. Verify compliance with licensing regulations; or C. Investigate complaints. #### Regulation .06 Administrative Enforcement. *COMAR 10.07.10.06* A. When a home health agency fails to comply with these regulations, the Department may: (1) Deny any application for a license; (2) Suspend or revoke a license; or (3) Issue a provisional license. B. Revocation, suspension, denial, or issuance of a provisional license shall occur in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. C. The Department may issue a provisional license for a period of less than 1 year in instances where: (1) The home health agency is in existence in Maryland at the time of promulgation of these regulations, and, therefore, requires a reasonable time period during which it may come into compliance with these regulations; (2) The home health agency has failed to demonstrate substantial compliance with the regulations but has indicated, in writing, its willingness to take the necessary corrective action to achieve substantial compliance. D. The Department shall designate the conditions and the time period under which a provisional license is being issued. E. A provisional license may not be renewed unless the deficiencies have been substantially corrected or a satisfactory POC implemented. A provisional license may not be issued for more than 2 consecutive years. #### Regulation .07 Notice to Patients. *COMAR 10.07.10.07* The home health agency shall notify each patient or the patient's authorized representative, the patient's attending physician, and any third-party payers at least 30 days before the voluntary surrender of its license, or as directed under an order of denial, revocation, or suspension of license issued by the Department. #### Regulation .08 Posting of License. *COMAR 10.07.10.08* A. The home health agency shall conspicuously post its license in its office and in each of its branch offices. The license shall be posted as to be viewable by the general public. B. In branch offices, the license shall be accompanied by a Departmental statement affirming the authority of the branch office to conduct its activities under the licensure authority of its parent agency. #### Regulation .09 Governing Authority. *COMAR 10.07.10.09* A. The home health agency shall have a duly constituted governing body, or designated persons so functioning, with full legal authority, responsibility, and accountability for its operation. B. Adoption of By-laws. (1) The governing body shall adopt written by-laws, in accordance with applicable legal requirements, for the conduct of business by the home health agency. (2) These by-laws shall include, at least the following: (a) A statement of objectives; and (b) An organizational structure by which agency policies and procedures are implemented. (3) These by-laws shall be reviewed annually and revised as necessary. C. The governing body shall appoint a home health agency administrator who shall be responsible for the overall management and fiscal operations of the agency. D. The governing body shall designate a “professional advisory group” whose functions shall include, at least: (1) To regularly review and advise on agency policies covering professional issues, including: (a) Scope of services offered; (b) Criteria for acceptance, discharge and/or rejection of patients; (c) Appropriateness of medical supervision; (d) Emergency care services to patients; (e) Adequacy of system for maintaining clinical records; (f) Adequacy of agency's review and evaluation program; and (g) Mechanism for referrals and continuity of care with allied health care providers; (2) To participate in the annual evaluation of the agency's programs. E. The Professional Advisory Group shall meet at least three times each calendar year and shall keep documented minutes. F. The governing body shall take appropriate actions on recommendations made by the professional advisory group. Complete documentation of recommendations made and actions taken shall be maintained. G. The governing body shall assure that all services offered by the home health agency, whether directly or indirectly, are: (1) Monitored and supervised by the parent agency; and (2) When stipulated by a physician's order, provided to an individual within 24 hours after the physician refers the individual to the agency. H. The home health agency shall establish a written contractual arrangement for the provision of all services which are not provided directly by the agency. At a minimum, the written contract shall: (1) Designate the services which are to be provided, the setting and the geographical area served (services provided are to be within the scope and limitations set forth in the plan of treatment and may not be altered in type, amount, frequency, or duration, except in the case of adverse reaction, by the individual under contract); (2) Describe how the contracted personnel are to be administratively or professionally supervised, or both; (3) Describe how services will be controlled, coordinated, and evaluated by the parent agency; (4) Describe the procedure for submitting clinical and progress notes, scheduling of visits, and periodic patient evaluations; (5) Specify the charges for specific services provided under contract; (6) Specify that only the parent agency shall bill for service and collect the applicable deductible or co-insurance payments; (7) Specify the period of time that the contract shall be in effect and how frequently it shall be reviewed; the contract shall be reviewed at least annually and renewed when necessary; (8) Insure that personnel and services contracted meet the requirements specified in these regulations for home health agency personnel and services, including licensure, personnel qualifications, physical examinations, functions, supervision, orientation, in-service education, and attendance at case conferences; (9) Provide for the acceptance of patients for home health services only by the parent agency. Patients may not be admitted for home health service by a contracted individual without prior review of the case and acceptance of the patient by the home health agency in accordance with agency policies. #### Regulation .10 Personnel. *COMAR 10.07.10.10* A. All professional personnel employed by or conducting business with a home health agency shall be licensed or duly authorized to conduct the business under the laws and regulations of the State. B. The home health agency shall have written policies on qualifications, responsibilities, and requirements for employment for each classification of personnel, including licensure where required. C. The policies of the home health agency shall, at a minimum, provide for: (1) Wage and salary schedules; (2) Eligibility for vacation, sick leave, and other fringe benefits; (3) In-service training and orientation of all personnel in the objectives, policies, and functions of the agency, including grievance procedures; and (4) Job descriptions for each classification of personnel. D. The policies of the home health agency shall be reviewed annually and revised as necessary. E. The home health agency shall maintain a complete and current personnel record for each employee and volunteer, which, at a minimum, shall include: (1) A certification that the employee is free from tuberculosis in a communicable form as provided in Regulation .14, of this chapter, only if the employee or volunteer: (a) Will be involved in the direct care of tuberculosis patients, or (b) Is an immigrant from Africa, Asia, or Latin America; (2) Evidence of current licensure, certification, or registration, as appropriate; (3) Evidence of the individual's qualifications for the position; and (4) Periodic performance evaluations. #### Regulation .11 Staff Supervision and Training. *COMAR 10.07.10.11* A. The Administrator shall appoint a full-time employee as a “service director” to provide general supervision and direction of the professional services offered by the home health agency. The service director, who shall be a physician, registered nurse, or an alternate professional, who is sufficiently qualified by advance training to supervise this service, shall be available at all times during operating hours of the home health agency and shall participate in all activities related to the professional services provided, including the qualifications of personnel as related to their assigned duties. In his absence, he shall appoint a similarly qualified designee. B. The nursing services of the home health agencies shall be provided under the supervision and direction of a registered nurse who is qualified by having 2 to 3 years experience or education in community health nursing. C. There shall be periodic, on-site supervision of services provided by home health aides, with complete and accurate documentation maintained. D. Training Requirements for Home Health Aides. Aides shall receive a periodic, structured program of training and orientation which includes, at a minimum: (1) The role of the home health aide as a member of the professional health services team; (2) Instruction and supervised practice in personal care services of the sick at home, with major attention being given to personal hygiene and activities of daily living; (3) Instruction in how to assist patients to achieve maximum self-reliance through re-learning and modifying activities of daily living; (4) Principles of good nutrition; (5) Meal planning, food purchasing, and preparation of meals, including special diets; (6) General information on the processes of growth, development, and aging; (7) Information on the emotional and physical problems accompanying illness; (8) Principles and practices in maintaining a clean, health, and safe environment as well as a pleasant one that encourages morale building and self-help; (9) Items requiring referral to the nurse supervisor in the home health agency, including changes in the patient's condition or family situation; (10) Record-keeping, when applicable; (11) Policies and objectives of the agency; (12) Information concerning the duties and responsibilities of a home health aide; and (13) Ethical behavior and confidentiality of information. E. Inservice education is required for all professionals including home health aides, on a quarterly basis. The subject matter, content, and attendance shall be documented for review during the survey process. #### Regulation .12 Clinical Records. *COMAR 10.07.10.12* A. A clinical record shall be maintained for each patient in accordance with accepted professional standards, including, at a minimum: (1) All pertinent diagnoses; (2) Name, address, and telephone number of physicians; (3) Physician's orders, including specific instructions for services to be rendered, activities and limitations, and medically-necessary supplies and equipment; (4) Drug information, including type, dosage, route of administration, frequency, and history of sensitivities or allergic reactions; (5) Nutritional requirements, including specific dietary plans; (6) Prognosis, including rehabilitation potential; (7) Patient care plans, which should include: (a) Long and short-range goals; (b) Physical needs, including safety measures to protect against injury; (c) Psycho-social needs; (d) Actions taken by individual disciplines; and (e) Evidence of periodic reappraisal of the needs of the patient; (8) Progress notes and modifications to the treatment plan; and (9) Discharge summary. B. The home health agency should maintain a unit record for all patients receiving multi-disciplinary care. C. All notes and reports entered in the clinic record shall be typewritten or written in ink, legible, dated and signed with the name and title of the person rendering service. D. The home health agency shall establish and implement policies concerning clinical records which assure: (1) That records of discharged patients are completed no later than 30 days after the date of discharge; (2) The proper operation of a system for identifying, filing, and retrieving clinical records; (3) Proper mechanisms for the timely transfer of clinical record information upon request from duly-authorized persons and organizations; (4) Proper safeguards for clinical record information against loss, destruction, or illegal or unauthorized use; (5) That clinical records are preserved for at least 5 years from the date of discharge; (6) That, with the approval of the Department, provisions are made for retention of clinical records when it ceases operation; and (7) That progress notes are recorded within 5 working days after service is delivered. The treatment plan shall be modified accordingly. E. A home health agency which provides maintenance health care or in-home services, or both, may not be required to maintain the same level of supervisory and record-keeping requirements of these regulations for those patients who only receive the maintenance health or in-home services. In these cases, the agency shall develop performance criteria, supervisory and record-keeping requirements for these patients. #### Regulation .13 Program Review and Evaluation. *COMAR 10.07.10.13* A. The home health agency shall establish policies and procedures for self-evaluation of its programs. These should include, at a minimum: (1) Evaluations of staffing patterns to assure adequacy and appropriateness of service delivered; (2) An annual review of programs to determine: (a) Trends in service needs and activities; (b) Problems and unmet needs of patients; (c) Anticipated changes in delivery of service; (d) Linkages with related community services. B. The home health agency shall review its written policies at least annually, and revise them as necessary. The results of this review shall be presented, in writing, to the professional advisory group and to the governing body. C. Utilization Review. (1) The home health agency shall establish a program of utilization review which, at a minimum, includes a utilization review committee to review clinical records at least quarterly. The committee members shall represent the scope of services offered by the agency. The clinical record review shall consist of a minimal sampling of 10 percent of unduplicated caseload records per annum or 40 records, whichever is less. All services offered shall be included in the sample. (2) Sixty Day Continuous Care Review. Each active record shall be reviewed at least every 60 days to determine the adequacy of the plan of treatment and appropriateness of continued service, including renewal of physician orders. D. The home health agency shall maintain a documented statistical reporting system for each county and the City of Baltimore, if served, which includes, at a minimum: (1) Number of patients by age, sex, and race receiving each service; (2) Number of patient visits conducted by each discipline; (3) Diagnostic categories; (4) Source of referrals; (5) Reason for discharge; and (6) Sources of reimbursement for all services. E. The home health agency shall: (1) Prepare a report annually of its documented statistics within 90 days after the close of its fiscal year; and (2) Beginning with the next fiscal year after adoption of this regulation, submit the report to the Department in the form and manner prescribed by the Secretary with each application for license renewal. #### Regulation .14 Patient's Bill of Rights. *COMAR 10.07.10.14* A. The home health agency shall provide each patient, client, or designated representative with a written statement affirming the agency's representatives support of a patient's bill of rights, including: (1) Upon request, a written statement of services offered, including frequency and unit charge; (2) Fully itemized, billing statements, including date of service and unit charge, to be made available on request of the patient; (3) Written disclosure of its policy on uncompensated care; (4) Upon request, information as to the identity of other health care providers with which the agency has contractual relationships, insofar as the patient's home health care is concerned; (5) The name of the responsible person supervising the patient's home health care and the manner in which that person may be contacted during regular working hours; B. To the extent reasonably possible, the home health agency shall provide for the patient's being consulted in the implementation of the home health care plan, including its likely outcome; C. The home health agency shall provide for the right of the patient to refuse any portion of planned treatment without relinquishing other portions of the treatment plan, except where medical contraindications to partial treatment exist; D. The home health agency shall provide a mechanism for the receipt and timely investigation of written complaints in which: (1) Disruption in service may not result from the filing of a complaint; (2) Complete files are maintained on the source, category, and disposition of the complaint; (3) A summary report is presented to the professional advisory group at its regular meetings; (4) A summary report is made available to the Department at least annually; and (5) A summary report is made available for public inspection, upon request. #### Regulation .15 Tuberculosis Screening. *COMAR 10.07.10.15* A. Certification of paid and unpaid personnel under Regulation .09E shall occur not later than 10 days after the beginning of service. Certification shall be accomplished in one of the following four ways as specified in §A(1)—(4), of this regulation: (1) If the individual has documentation of a negative tuberculin test by the Mantoux method within the past 24 months and has, by history, no contact with a person with tuberculosis in a communicable form following this documentation or no symptoms consistent with tuberculosis, the individual shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form. Further skin testing is not necessary, except for epidemiologic diagnostic purposes which may be required by the local health officer or the Department. (2) If the individual does not have documentation of a negative tuberculin test by the Mantoux method within the past 24 months and does not have a history of having had a positive tuberculin test by the Mantoux method, the following procedure shall be done: (a) Five tuberculin units (TU) of purified protein derivative (PPD) shall be administered intradermally and the results read 48—72 hours following the administration of the test; (b) An individual with induration of 5—9 millimeters and no history of contact with a person with tuberculosis in a communicable form or an individual with induration of 0—4 millimeters shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form; (c) An individual with induration of 5—9 millimeters and a history of contact with a person with tuberculosis in a communicable form or an individual with induration of 10 millimeters or more shall be considered to be a positive tuberculin reactor and shall be handled as described in §A(3)(a)—(c), of this regulation. (3) If the individual is a positive tuberculin reactor as defined in §A(2)(c), of this regulation, or if the individual has a history of a positive tuberculin test by the Mantoux method without documentation of having received an adequate course of therapy, as defined by the local health officer, for tuberculosis disease or received adequate prophylaxis, as defined by the local health officer, for tuberculosis infection, the following procedure shall be done: (a) If the individual does not have documentation of a negative chest X-ray within the past 12 months, the individual shall be evaluated by a chest X-ray. If the chest X-ray is negative, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray in 12 months, unless isoniazid therapy is instituted, in which case the second chest X-ray is unnecessary. (b) If the individual has documentation of a negative chest X-ray within the past 12 months, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray 12 months after the individual's most recent documented chest X-ray unless isoniazid therapy has been instituted, in which case the second chest X-ray is unnecessary. (c) If the individual has had two successive negative chest X-rays 12 months apart, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. (4) If the individual has documentation of an adequate course of therapy, approved by the local health officer, for tuberculosis disease or adequate prophylaxis, approved by the local health officer, for tuberculosis infection, further chest X-rays are not necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. B. The agency shall instruct each employee and volunteer in the signs and symptoms of active tuberculosis and advise the individual to seek immediate medical care should the individual detect these signs or symptoms. C. If the individual meets any of the following criteria in this section, the agency shall have written policies and procedures, acceptable to the Department, for the evaluation, management, and surveillance of this individual. The criteria include: (1) A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer; (2) Current treatment for tuberculosis disease or tuberculosis infection; (3) Chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or (4) Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months. D. The following records shall be maintained by the agency: (1) Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading, and results of tests; (2) Results of X-rays required in §A(3)(a)—(c), of this regulation; and (3) Documentation of any Mantoux test, chest X-ray, chemotherapy, and chemoprophylaxis which is the basis for the certification that the individual is free from tuberculosis in a communicable form. #### Regulation .16 Rehabilitation Services. *COMAR 10.07.10.16* A home health agency that holds itself out to the public as providing a complete array of physical rehabilitation services shall: A. Provide a program of coordinated interdisciplinary rehabilitative care that shall include: (1) Physical and occupational therapy, (2) Speech and language therapy, (3) Audiology therapy, (4) Psychotherapy, and (5) Social work services; B. Hold interdisciplinary meetings with the involvement of a physician to plan and monitor patient care; and C. Meet any other applicable standard required by law. ### Chapter 11 — Health Maintenance Organizations **Authority:** Health-General Article, §19-701 et seq.; Insurance Article, §2-109(a)—(c); Annotated Code of Maryland **Administrative History:** Effective date: June 16, 1978 (5:12 Md. R. 967) **Administrative History:** Regulations .01E, .02, .03. .04B. .05D, .07E, .09B, .10B, .11A, .12B and C amended effective June 29, 1987 (14:13 Md. R. 1472) **Administrative History:** Regulation .01 amended effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .01 recodified to Regulation .01-1 and the Scope paragraph codified as Regulation .01 in May, 1993 **Administrative History:** Regulation .01-1B amended effective December 9, 2004 (31:24 Md. R. 1726) **Administrative History:** Regulation .04A amended effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .04B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .05B amended effective December 9, 2004 (31:24 Md. R. 1726) **Administrative History:** Regulation .07 amended effective June 22, 1992 (19:12 Md. R. 1134); December 9, 2004 (31:24 Md. R. 1726) **Administrative History:** Regulation .09A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .10 amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted as an emergency provision effective March 3, 1999 (26:7 Md. R. 535); emergency status expired September 3, 1999; adopted permanently effective September 6, 1999 (26:18 Md. R. 1376) **Administrative History:** Regulation .11D and E adopted effective June 22, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .13 repealed effective June 22, 1992 (19:12 Md. R. 1134) #### Regulation .01 Scope. *COMAR 10.07.11.01* The purpose of these regulations is to regulate various phases of the operations of health maintenance organizations in accordance with the mandates of Health-General Article, §§19-701—19-734, Annotated Code of Maryland. #### Regulation .01-1 Definitions. *COMAR 10.07.11.01-1* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Physicians. (1-1) “Certified nurse practitioner” has the meaning stated in Health Occupations Article, Title 8, Annotated Code of Maryland. (2) “Commissioner” means the Insurance Commissioner of Maryland. (3) “Department” means the Maryland Department of Health. (4) “Enrollee” means a person who has entered into a health care services contract or on whose behalf a contractual arrangement has been entered into with a health maintenance organization (HMO). (5) “Governing authority” means the person or persons designated in the bylaws with the responsibility for operating the HMO. (6) “Grievance” means any complaint by an enrollee: (a) That the enrollee has not received any benefit or other right to which the enrollee is contractually entitled or that the enrollee has been treated unprofessionally or otherwise improperly by the HMO, or a provider engaged by the HMO; (b) Which is not resolved formally to the satisfaction of the enrollee. (7) “Operating year” means the consecutive 12-month period, or part thereof, during which the HMO makes available health services as delineated in its Certificate of Authority (as issued by the Insurance Commissioner), and beginning on the issuance date of this Certificate. (8) “Out-of-area coverage” means contractual benefits provided by the HMO to its enrollees with respect to emergency health care services received by enrollees outside the primary geographical area served by the HMO. (9) “Physician” means an individual authorized by law to practice medicine in the State. (10) “Preventive services” means those services designed to prevent the occurrence of disease or injury or to arrest disease at an early stage before complications and serious disabilities develop. (11) “Quality of health care” means that level of health care delivered which reflects the general health care standards and practices in the geographical area served by the HMO. (12) “Secretary” means the Secretary of Health. #### Regulation .02 Service Requirements. *COMAR 10.07.11.02* A. The HMO shall provide the services required by the Maryland Health Maintenance Organization Act of 1975, Health-General Article, §19-701(d), Annotated Code of Maryland. B. The HMO shall make available and encourage appropriate history and baseline examinations for each enrollee within a reasonable time of enrollment set by the HMO. Medical problems that are a potential hazard to the person's health shall be identified and a course of action to alleviate these problems outlined. Progress notes indicating success or failure of the course of action shall be recorded. C. The HMO shall offer or arrange for preventive services that include health education and counseling, early disease detection, and immunization. The HMO shall develop or arrange for periodic health education on subjects which impact on the health status of the enrollee population and shall notify every enrollee in writing of the availability of these and other preventive services. D. Services to prevent a disease shall be offered if all of the following conditions exist: (1) The disease produces death or disability and exists in the enrolled population; (2) The etiology of the disease is known or the disease can be detected at an early stage; (3) Elimination of factors leading to the disease or immunization has been proven to prevent its occurrence, or early disease detection followed by behavior modification, environmental modification, or medical intervention has been proven to prevent death or disability. E. An HMO shall offer services through a licensed health care practitioner who is not a physician if the: (1) Services are within the scope of practice for both: (a) A physician; and (b) Another licensed health care practitioner; and (2) HMO considers the offering of the practitioner's services appropriate. #### Regulation .03 Quality Assurance Requirements — Program Planning and Evaluation. *COMAR 10.07.11.03* A. The HMO shall have a written program plan that is updated and reviewed at least every 3 years. B. The plan shall include the following information: (1) Statistics on age, sex, and other general demographic data used to determine the health care needs of its population; (2) Identification of the major health problems in the enrolled population; (3) Identification of enrolled special groups that have unique health problems such as the poor, the elderly, the mentally ill, and educationally disadvantaged; (4) A description of community health resources and how they will be used. C. Priorities and Objectives. The HMO shall state its priorities and objectives in writing, describing how the priorities and objectives relating to the health problems and needs of the enrolled population will be provided for. D. Services. At the time membership is solicited, the HMO shall provide a general description of services available to enrollees including: (1) Benefit limitations and exclusions; (2) Location of facilities or providers; and (3) Procedures by which a member would obtain medical services. E. On each enrollment card or application, the HMO shall: (1) Place the following statement in bold print: “If you have any questions concerning the benefits and services that are provided by or excluded under this agreement, please contact a membership services representative before signing this application or card”; and (2) Provide information on how a prospective member may contact a membership services representative. F. The plan shall contain evidence that: (1) Programs and services offered are based on the health problems of, and the community health services available to, the enrolled population; (2) There is an active program for preventing illness, disability, and hospitalization among enrollees; (3) Services designed to prevent the major health problems identified among child and adult enrollees and to improve their general health are provided by the HMO. #### Regulation .04 Peer Review. *COMAR 10.07.11.04* A. Internal Review. The HMO shall have an internal peer review system that will evaluate the utilization of services and the quality of health care provided enrollees. The review system shall: (1) Provide for review by appropriate health professionals of the process followed in the provision of health services; (2) Use systematic data collection of performances and patient results; (3) Provide interpretation of this data to the practitioners; (4) Review and update continuing education programs for health professionals providing services to enrollees; (5) Identify needed change and proposed modifications to implement; (6) Maintain written records of the internal peer review process; (7) Conduct focused studies directly related to major health problems and preventive health needs identified in Regulation .03B and C of this chapter; and (8) Assure that at least three focused studies related to the HMO specific plan under Regulation .03 of this chapter are conducted each year. B. External Review. (1) The Department shall conduct an external review of the quality of health care services of the HMO when and in a manner the Department considers appropriate. (2) The external review shall be conducted by: (a) A panel of physicians and other health professionals consisting of persons who: (i) Have been approved by the Department; (ii) Have substantial experience in the delivery of health care in an HMO setting but who are not members of the HMO staff or performing professional services for the HMO concerned; (iii) Reside outside the area serviced by the HMO; or (b) The Department. (3) The final decision on which type of external review is to be employed rests solely with the Department. (4) The external review shall consist of a review and evaluation of the following: (a) Internal peer review system and reports; (b) The HMO program plan to determine if it is adequate and being followed; (c) The professional standards and practices of the HMO in every area of services provided; (d) The grievances relating specifically to the delivery of medical care, including their final disposition; (e) The physical facilities and equipment; and (f) A statistically representative sample of enrollee records. (5) A health maintenance organization accredited by an accreditation organization approved by the Secretary in accordance with Health-General Article, §19—2302, Annotated Code of Maryland, shall be exempt from the external review. #### Regulation .05 Medical Records. *COMAR 10.07.11.05* A. The HMO shall maintain an individual record for each patient according to accepted professional principles and the provisions of these regulations, with entries kept current, dated, and signed by a physician or other medical professional. B. All information contained in the medical records and information received from physicians, surgeons, certified nurse practitioners, or hospitals, incident to the health care practitioner-patient or hospital-patient relationship, shall be kept confidential, and, except for use incident to bona fide medical research and education, or for the Department's review under these regulations, or as reasonably necessary in connection with the administration of the member's contract, may not be disclosed without the consent of the patient. C. Contents and Procedures. The medical record shall contain at least the following information and be maintained under the following procedures: (1) Identification and summary sheets; (2) Prior medical findings and referral information; (3) Information necessary to support the diagnosis and justify the treatment given as shown in the individual written plan of treatment; (4) Progress notes by a medical staff member, as appropriate; a physician shall review and approve the progress notes within 24 hours of entry; (5) Dated record of all treatments, medications, laboratory tests, X-rays, operative reports, anesthesia records, and measurements; (6) Consultation report, if appropriate; (7) Record of any emergency care treatment rendered to patient; and (8) Discharge summary of inpatient hospitalization to include condition at time of discharge and post operative instructions given to the patient. D. It is the responsibility of each attending clinical staff member to complete and sign the medical records of each ambulatory patient the staff member treats, within 72 hours of treatment. E. The HMO shall maintain a system for identifying and filing records which provides for: (1) A universal identifier; and (2) Adequate space and equipment for filing and prompt retrieval of medical records. F. The HMO shall have established policies assuring that medical records of current enrollees and enrollees who leave the HMO plan are completed, promptly filed, and retained in safekeeping according to acceptable professional practices and State statutes. G. When the HMO provides services directly to its enrollees at several locations, it shall ensure, through the coordination of medical records and the use of other appropriate operating procedures, that the services it furnishes at those various locations are organized in this manner as to facilitate continuity of care. A central patient record keeping system shall be maintained as required by the Department. H. The HMO shall designate a member of the staff qualified by reason of training or experience, or both, who is responsible for the implementation of medical record policies and for the maintenance of the medical record system. #### Regulation .06 Statistics. *COMAR 10.07.11.06* The HMO shall provide the Department with full access to all operational and statistical data to enable the Department to verify the HMO's compliance and to enable the Department to conduct specific statistical studies with respect to current status of various segments of the enrolled population. #### Regulation .07 Personnel. *COMAR 10.07.11.07* A. When applicable, each staff member of the HMO shall be licensed as required by State and local law, and meet acceptable professional qualifications or have qualified by means of an occupational proficiency examination or through acceptable training. Provider staff patterns shall be designed to meet enrollee needs. B. The HMO shall provide orientation for all new employees and require continuing education of all professional and supportive personnel which reflects advances in medical knowledge and enrollee health education. C. The HMO shall establish a formal written process for: (1) Appointment of a physician or certified nurse practitioner to the clinical staff of the HMO; (2) Employment of a physician or certified nurse practitioner by the HMO; or (3) Selection of a physician or certified nurse practitioner to provide services to the enrollees under contract with the HMO. D. Information Concerning a Physician's or Certified Nurse Practitioner's Background and Training. (1) As part of the formal written process in §C of this regulation, the HMO shall collect, review, and verify the information concerning a physician's or certified nurse practitioner's background and training in §D(2) and (3) of this regulation. (2) Information that shall be collected, reviewed, and verified for a physician or certified nurse practitioner includes: (a) Evidence of education; (b) Evidence of current license to practice in the State; (c) Evidence of internship, residency training, or other pertinent training; (d) Evidence of specialty certification; (e) Evidence of Drug Enforcement Administration or Controlled Dangerous Substances registration; (f) Evidence of malpractice insurance coverage; (g) Physical and mental status; (h) List of all hospitals where the physician or certified nurse practitioner has current privileges or is employed; (i) Evidence of any adverse action or restriction of privileges imposed by any hospital or Board; (j) Delineation of services to be provided to patients at the HMO; (k) Past malpractice claims history; (l) Verification of status through the federal National Practitioner Data Bank; and (m) Cooperative arrangement with a physician for each certified nurse practitioner. (3) For a physician who has privileges in a licensed Maryland hospital, the HMO may verify, through the hospital, the credentials described in §D(2)(a)—(f) of this regulation. E. Reevaluation of Physicians or Certified Nurse Practitioners. (1) The HMO shall establish a formal written process for the reevaluation of appointment, employment, or selection of a physician or certified nurse practitioner. (2) The reevaluation shall include an ongoing process for verifying: (a) Current State Licensure; (b) Current Controlled Dangerous Substances or Drug Enforcement Administration registration; and (c) Evidence of current malpractice insurance. (3) Every 3 years, the reevaluation also shall include the following for all physicians and certified nurse practitioners: (a) An update of the requirements of §D of this regulation; (b) An assessment of the performance pattern based on an analysis of: (i) Complaints filed through the grievance system; (ii) Malpractice claims filed; (iii) Utilization, quality, and risk data; (iv) Adherence to policies, bylaws, and procedures; and (v) Physician and certified nurse practitioner practice patterns as reviewed through the HMO's quality assurance program. F. Administrator. (1) At least one administrator shall be appointed by the governing body and delegated the responsibility for the internal operation of the HMO according to established policies. The administrator's responsibility for procurement and direction of personnel shall be clearly defined. An individual competent and authorized to act in the absence of the administrator shall be designated. (2) The HMO shall notify the Department of the name of the person appointed administrator and of any change in the appointment. G. Medical Director. The HMO shall have a medical director who is licensed to practice medicine in the State. A physician authorized to act in the absence of the medical director shall be designated. The medical director shall oversee the quality of care provided to the HMO's patients. If the medical director becomes aware of unethical or unprofessional conduct on the part of any health provider, the medical director shall take appropriate action to prevent future occurrences of this conduct. H. The HMO shall have a licensed registered nurse present to perform nursing services at all times that these services are required. #### Regulation .08 Policy Formulation. *COMAR 10.07.11.08* A. The HMO shall have written policies governing the provision of the HMO services according to stated objectives of the HMO. The policies shall be developed in consultation with the executive officer, representative professionals, including one or more physicians, nursing service personnel associated with the service, and one or more enrollee representative or representatives. Policies shall be approved by the governing authority and reviewed and revised annually as required. These approvals shall be affirmed in writing and dated by an authorized representative of the governing authority. B. Patient Care Policies. The policies shall cover at least the following: (1) Inpatient admission and discharge policies; (2) Physician (Independent Practice Association) services, including medical staff organization; (3) Provision of or arrangements for other services not directly provided by the HMO; (4) Continuity and availability of care through an established referral mechanism and ongoing contract with other health services providers. #### Regulation .09 Access and Availability of Services. *COMAR 10.07.11.09* A. Regular Hours. (1) With respect to all services it furnishes, whether direct or through contractual arrangements, an HMO shall provide for regular hours during which an enrollee may receive services. (2) An HMO that provides services directly to its enrollees through its staff members shall have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services. (3) An HMO that provides services to its enrollees through independent licensed health care providers under contract with the HMO shall ensure that the providers have an orderly system for scheduling the provision of services to enrollees in a timely manner, taking into account the immediacy of need for services. B. Outside of Regular Hours. The HMO shall have a system for providing the enrollee with 24-hour access to a physician in cases where there is an immediate need for medical services. To meet this requirement, the HMO's arrangements for off-hour services may provide for access to physicians who do not have a contract with the HMO and facilities such as hospital emergency rooms. When a physician who does not have a contract with the HMO is used, the HMO shall develop and publicize procedures assuring that the HMO is notified of the services and receives adequate documentation from the physician or facility within a reasonable period of time. #### Regulation .10 Physician Availability. *COMAR 10.07.11.10* A. The HMO shall have a physician available at all times to provide diagnostic and treatment services. The HMO shall assure that every enrollee seen for a medical complaint is evaluated under the direction of a physician and that every enrollee receiving diagnostic evaluation or treatment is under the direct medical management of an HMO physician who provides continuing medical management. B. Each enrollee shall have an opportunity to select a primary physician or certified nurse practitioner from among those available to the HMO. #### Regulation .11 Complaint System for Quality of Care Issues. *COMAR 10.07.11.11* A. The HMO shall have a: (1) Written procedure to assist and respond to enrollees, families, and providers on complaints concerning quality of care issues; and (2) Designated department to handle complaints. B. Quality of care issues include, but are not necessarily limited to: (1) Bad outcomes related to poor care; (2) Failure to follow-up on diagnostic procedures; (3) Failure to provide treatment for presenting complaints consistent with standard of care; (4) Failure to appropriately document medical records; (5) Confidentiality and privacy issues related to medical records or provision of care; (6) General dissatisfaction with care; (7) Qualifications of individuals who are: (a) Employees of the HMO; or (b) Under contract with the HMO to provide services to enrollees; (8) Misdiagnosis; (9) Inappropriate referral to meet enrollees' needs; (10) Environmental issues related to infection control and hazardous medical waste; (11) Failure of a provider to perform adequate medical screening, assessments, or timely care in emergency situations; (12) Failure to provide an adequate internal enrollee complaint process concerning quality of care issues; (13) Failure to comply with policies and procedures concerning delivery of care; or (14) Inadequate credentialing and performance appraisal for physicians. C. The HMO shall: (1) Submit the written procedure to the Department for approval before distributing to enrollees; (2) Obtain Departmental approval of any revision to the written procedure before implementing the proposed change; and (3) Distribute the approved written procedure to all enrollees. D. The written complaint procedure shall include, at a minimum, the: (1) Department of the HMO that the enrollee or family member may contact if the enrollee wishes to make a complaint or obtain information concerning a complaint; (2) Complaint department's address and telephone number; (3) Procedure for investigating the complaint; (4) Time frame in which the HMO shall provide a final response to or resolve the enrollee's complaint, not to exceed 60 days; and (5) Telephone number of the Maryland Insurance Administration if the enrollee wishes to pursue a complaint regarding quality of care issues outside of the HMO's complaint system. E. The HMO shall treat the enrollee with dignity, courtesy, and due regard for the individual's privacy. F. The HMO shall maintain a written record of complaints and responses for at least 5 years following the date the complaint was received by the HMO. G. Investigation by the Department. (1) The Maryland Insurance Administration is the single point of entry for all complaints to State government filed by an HMO enrollee. The Maryland Insurance Administration shall refer all quality of care complaints, as defined in §B of this regulation, to the Department for investigation. (2) The Department may: (a) Refer a complaint directly to an HMO for resolution; or (b) Conduct an independent investigation. (3) If the Department refers the complaint to an HMO, the HMO shall provide the following information in writing to the Department within 30 days of receipt of the complaint: (a) The results of the investigation; (b) Any change or proposed change to HMO policies or procedures as a result of the investigation; and (c) The HMO's method to prevent recurrence of the problem. (4) If the HMO has not completed the investigation within 30 days, the HMO shall send the Department an interim report with a summary of the investigation to date and the expected date of completion. The expected date of completion may not be longer than 60 days from receipt of the complaint. #### Regulation .12 Inspections. *COMAR 10.07.11.12* A. HMO to Be Open for Inspection. An HMO shall be open to inspection by representatives of the Department and by any agency designated by the Department. B. Frequency of Inspection. (1) The Department shall inspect each HMO periodically at reasonable times. (2) The Department shall monitor continuously the health care services of an HMO: (a) From the time of notice by the Commissioner that the HMO is not operating in a fiscally sound manner; and (b) Until: (i) The Commissioner notifies the Department that the HMO is operating in a fiscally sound manner; and (ii) The Secretary determines that further continuous monitoring is not warranted. C. Records and Reports. HMO's shall keep records and shall make reports as the Department shall prescribe. All records shall be open to inspection by representatives of the Department. #### Regulation .13 Repealed. *COMAR 10.07.11.13* #### Regulation .14 Waiver Authority. *COMAR 10.07.11.14* The Department may grant waivers to the provisions of these regulations when this action is demonstrated to be in the best interests of the general public. Waivers may be granted for a 1-year period, are renewable, and are subject to reconsideration at any time. ### Chapter 12 — Health Care Facilities Within Correctional Institutions **Authority:** Health-General Article, §§19-307, 19-308, 19-320, and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: June 16, 1978 (5:12 Md. R. 967) **Administrative History:** Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .20A amended effective March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Scope. *COMAR 10.07.12.01* These regulations are applicable to all health care facilities within correctional institutions and include those services provided inmates who report to the health care facility on an out-patient basis. These regulations do not include infirmaries which do not house patients overnight. #### Regulation .02 Definitions. *COMAR 10.07.12.02* A. “Communicable disease programs” means the provision of services that will assist in the prevention of communicable disease. B. “Department” means the Maryland Department of Health. C. “Health care facility” means a specified area within the correctional institution in which general and clinical health care services are provided to inmates in the custody of the Division of Corrections. D. “Health care program” means a document prepared by the facility and approved by the Department which lists the following: (1) The number of beds; (2) Organizational structure; (3) A description of the care, treatment, and services provided for inmates; (4) Admission policies; (5) Discharge and referral policies and procedures; (6) The staffing pattern by shifts; (7) The job classification and job descriptions of each employee. E. “Inpatient” means an inmate not requiring acute hospital care but requiring services of licensed nursing personnel or supportive services which he cannot perform for himself. F. “Referred services” means those appropriate services provided to inmates based on individual medical needs in the area of psychiatric services, dental care, or emergency care. G. “Sick call” means the medical care provided to inmates not classified as inpatients but who have expressed a need for medical attention or who have been referred to the health care facility by the appropriate personnel in the correctional institution. #### Regulation .03 Compliance with State and Local Laws, Ordinances, Regulations, or Orders. *COMAR 10.07.12.03* A. Each correctional facility shall demonstrate to the Department its compliance with applicable State and local ordinances, laws, regulations, and orders as they apply to the use of facilities for health, welfare and safety. B. Fire code requirements shall be: (1) In accordance with the NFPA 101 Life Safety Code as adopted as part of the State Fire Prevention Code of Maryland; (2) Annual inspection and approval by the State fire authority. #### Regulation .04 License Procedure. *COMAR 10.07.12.04* Applicants for licensure shall conform to the following: A. Any person desiring to open and operate a health care facility within a correctional institution or to continue the operation of an existing health care facility, shall file a written or electronic application with the Department giving the information required by the Office of Health Care Quality; B. The applicant shall submit a synopsis of the health care program to be offered with the application; each subsequent application shall include a list of changes in the original program. #### Regulation .05 Transfer or Assignment of License. *COMAR 10.07.12.05* A. Transfer or assignment of the license is prohibited. B. A separate license shall be required for each health care facility operated within the correctional institution. #### Regulation .06 Inspections. *COMAR 10.07.12.06* A. Health Care Facility to be Open for Inspection. Health care facilities, and any premise proposed to be operated by an applicant for a license, shall be open at all reasonable times to inspection by the Secretary of Health and by any agency designated by the Secretary of Health. B. Frequency of Inspection. Health care facilities shall be inspected by the Secretary of Health at least once during each 1-year period for which a license is granted to determine whether the health care facility is complying with the minimum standards established pursuant to these regulations. C. Records and Reports. All records shall be open to inspection by authorized representatives of the Department. Except where authentication may be required, the disclosure of patient names to the Division of Licensing and Certification surveyor may not be required. The representatives of the Department shall maintain confidentiality of all the data disclosed to them. #### Regulation .07 Policies and Procedures. *COMAR 10.07.12.07* Written policies and procedures shall be established for the following services: A. Physician services; B. Health care services; C. Staffing; D. Emergency care; E. Medical research; F. Communicable diseases; G. Medical examinations and evaluation process; H. Pharmacy services; I. Dietary services; J. Nursing Services. #### Regulation .08 Communication. *COMAR 10.07.12.08* There shall be a telephone in the health unit and additional telephones or extensions or communication systems as required by the Department to summon help in case of fire or other emergency. #### Regulation .09 Physician Services. *COMAR 10.07.12.09* A. Medical Examination. Each newly received inmate to the health facility shall be examined within 2 working days after his admission as to his medical condition. A record of each examination shall be kept as part of the permanent medical record. B. Availability. A licensed physician shall be readily available to take care of the medical needs of the inmates. Physician services may be provided through the following arrangements: (1) A contract with a local physician to provide coverage on specified hours and for emergencies; or (2) Affiliation with a local hospital to provide medical services required by the health care facility. #### Regulation .10 Psychiatric Services. *COMAR 10.07.12.10* Psychiatric services shall be provided according to the needs of the patients. #### Regulation .11 Surgical Services. *COMAR 10.07.12.11* Each health care facility desiring to perform surgical procedures shall first obtain approval from the Department. #### Regulation .12 Health Care Services. *COMAR 10.07.12.12* A. Health care services shall be provided according to the needs of the inmates and shall be designed to maintain the highest possible degree of function, self-care, and independence. B. A health care program shall be developed to insure prompt treatment of injury or illness. C. The health care facility shall provide equipment necessary for medical care according to the needs of the patients. D. An individual medical record shall be maintained for each patient. The record shall indicate their condition at the time of admission, reports of illness and injury, medical treatment provided, results of treatment, and their condition at the time of discharge. #### Regulation .13 Staffing. *COMAR 10.07.12.13* A. The health facility shall provide the number and level of personnel sufficient to meet the total needs of the patient. B. Health facilities shall employ licensed personnel to provide medical services when applicable. C. The facility shall provide personnel who are qualified by both training and experience in the handling of health emergencies. #### Regulation .14 Emergency Care. *COMAR 10.07.12.14* Each health facility in cooperation with the facility physician shall set forth in writing, to all personnel, the routine procedure for summoning appropriate medical care personnel. #### Regulation .15 Medical Research. *COMAR 10.07.12.15* Each health facility involved in medical research shall follow standards developed by the American Correctional Association for the safety and well-being of the inmate population. #### Regulation .16 Communicable Disease. *COMAR 10.07.12.16* A. Cross-infection shall be guarded against by prompt isolation of diagnosed and suspected cases of communicable disease. Room furnishings, equipment, and supplies shall be kept clean at all times, properly cleaned after use, and disinfected. B. Reports of Disease. The occurrence of an infectious disease, food poisoning, or dysentery, shall be reported immediately by the examining physician to the local health department and to the Division of Licensing and Certification. #### Regulation .17 Medical Examination and Evaluation Process. *COMAR 10.07.12.17* A. Written policies and procedures shall be developed and maintained in consultation with representatives of the medical staff, nursing service, and administration governing the provisions for the control of the sick call process and referral services. They shall address the following: (1) Screening Procedures. (a) Routine handling of patient complaints; (b) Non-routine handling of patient complaints. (2) Reporting Procedure. A responsible staff member to whom an inmate can report injuries, symptoms of illness, and emergencies shall be on duty at all times and be immediately accessible. (3) Complaint Procedure. Complaints of illness or injury shall be recorded in the inmate's clinical record together with the treatment prescribed. (4) Examination Procedure. The procedure shall specify where the examination area is located as well as who is to perform the examination. (5) Procedures to be followed by the correctional officer in attendance. #### Regulation .18 Staff Development. *COMAR 10.07.12.18* A. There shall be a combined orientation and continuing education program at least every 2 months for all personnel. Documentation shall be available to include date, time, topic discussed, speaker, and members present. A coordinated training program with a local hospital is encouraged. B. There shall be health care orientation and training for correctional officers assigned to medical facilities. Assignments and activities of correctional officers in medical areas shall be established. #### Regulation .19 Pharmacy Services. *COMAR 10.07.12.19* A. Procedures for Administration of Pharmaceutical Services. Each facility shall comply with all federal, State, and local laws, ordinances, standards and codes regulating the purchasing, storage, dispensing, administration, and recording of drugs. Each health care facility shall: (1) Ensure that pharmaceutical services are provided; (2) Make provision for prompt and convenient acquisition of prescribed drugs; (3) Record all supplies and drugs requisitioned and received from the pharmacy; (4) Record all prescriptions dispensed; (5) Obtain a permit to operate a pharmacy from the Board of Pharmacy in the State if the pharmacy is located within the correctional facility; (6) If the facility has no pharmacy, there shall be a written agreement for qualified pharmacy services, including provision for emergency service and consultation. B. Staff Requirements. (1) Pharmaceutical service, when provided within the health care facility, shall be under the direction and supervision of a pharmacist licensed to practice pharmacy in the State. (2) The staff or consultant pharmacist at each correctional facility shall participate in planned inservice education programs for the facility on topics related to pharmaceutical services. (3) The consultant pharmacist shall be available to assist in formulating the procedures, rules, and regulations for the acceptable distribution of drugs throughout the correctional system and shall visit the facility on a regular basis to review all aspects of the services provided and to ensure that proper controls are maintained. C. Formulary. There shall be a formulary system, approved by the institutional physician and pharmacist and by other appropriate facility staff. Copies of the formulary shall be located and available as appropriate to the institution. D. Space and Equipment. If the pharmacy is located within the health care facility there shall be adequate space and equipment to house the drugs and supplies. The pharmacist and pharmacy personnel, under the direct supervision of the pharmacist, may not dispense medications, make label changes, or transfer medications on other than the original containers. Documentation of the qualifications of the pharmacy personnel shall be available. E. Emergency Kit. There shall be an emergency drug kit immediately available at each nursing or service area for use by medical personnel. Written policies and procedures establishing the contents of the supply and procedures establishing the contents of the supply and procedures for use, restocking, and sealing of the emergency drug supply shall be available. A list of drugs shall be signed by the pharmacist and physician and attached to the kit. F. Stop Order Policy. Automatic stop orders on all drugs shall be maintained by the medical and pharmacy staff. These orders may not apply when the physician indicates a specific period of time a drug is to be used, or a specific number of dosages. G. Medication Release. All medications to be released to the patient shall be approved in writing by the physician. A notation concerning their disposition shall be made on the patient's clinical record. H. Administration of Medications. (1) All medications shall be administered by licensed medical or nursing personnel or by personnel who possess written documentation of training in theory and practice in the administration of medications. This written documentation shall be available for review by the Department. (2) The person assigned the responsibility of administering medications to inpatients shall complete the procedure by: (a) Personally preparing the dose; (b) Observing the act of swallowing the oral medications; (c) Recording the act of administration. (3) In the case of unit dose medications the person administering medication shall: (a) Open the unit dose package; (b) Observe the taking and swallowing of the medication; (c) Record the administration of the medication. (4) Medication shall be given only to the individual patient for whom the prescription was issued and shall be given according to directions as prescribed. (5) Medication cards and lists, or acceptable substitutes, shall be used and checked against the physician's orders when administering medications to inpatients. (6) Self-administration of medications by patients shall be permitted only when specifically ordered by the attending physician. (7) Medication errors and drug reactions shall be reported to the physician responsible for the resident. An entry of the medication error or the drug reaction or a combination of both, shall be recorded in the patient's record. (8) Current pharmaceutical reference materials shall be provided in order to furnish the medical, pharmacy, and nursing staffs with current information concerning the drugs used in the hospital. I. Investigational Drugs. Investigational drugs, properly labeled according to federal regulations, may be used only under the direct supervision of the principal investigator and after written consent is obtained from the patient. The drugs shall be approved by an appropriate medical staff committee acting according to established policies and procedures. Only physicians and nurses may administer investigative drugs after they have been made aware of the essential pharmacologic information necessary for them to discharge their professional responsibilities. A central location shall be established where information on investigational drugs being used is maintained. J. Labeling and Storing of Medication. (1) All medications shall be properly labeled and stored in a locked cabinet at the medical unit. The key to this cabinet shall be in the possession of authorized personnel. The labels shall bear the name and strength of the drug, expiration date of all time-dated drugs, name of the pharmacy issuing the drug, name of patient, and federal and State cautionary statements. Necessary labels shall be affixed to the labeled container. (2) Medications requiring refrigeration shall be kept in a locked refrigerator. Poisons and medication for “external use only”, including rubbing alcohol, shall be kept in a locked cabinet or compartment separate and apart from internal medications. (3) Discontinued and outdated drugs, and containers with worn, illegible, or missing labels, shall be returned to the pharmacy for proper disposition. (4) A drug recall procedure shall be established that can be readily implemented. (5) Drug cabinets on the medical units shall be checked by the pharmacist at least every 2 months. K. Control of Schedule II and Legend Drugs. (1) All Schedule II drugs shall be kept in a separately locked, securely fastened compartment within the locked medicine cabinet. (2) All Schedule II drugs retained on each nursing unit shall be counted at the termination of each tour of duty. This record shall be signed by both the outgoing and incoming professional nurse or authorized person. Schedule II drugs which are outdated and no longer in use shall be disposed of according to federal regulations. All other discontinued or outdated drugs shall be disposed of according to State regulations. #### Regulation .20 Dietary Services. *COMAR 10.07.12.20* A. Adequacy of Diet. The food and nutritional needs of patients shall be met according to physician's orders. B. Therapeutic Diets. (1) The therapeutic diet prescribed by the attending physician shall be prepared and served as part of the course of treatment of the patient. If the dietary requirement is beyond the capability of the facility, other arrangements for the nutritional needs shall be made by the health care facility physician. (2) A diet manual approved by the physician or dietitian shall be available. C. Frequency and Quality of Meals. At least three meals or their equivalent shall be served daily, at regular times, with not more than a 14-hour interval between the evening meal and breakfast. D. Planning of Menus. Menus shall be planned in advance and food sufficient to meet the nutritional needs of residents shall be prepared as planned for each meal. When menu changes are necessary, substitutions shall provide equal nutritional value. E. Preparation of Food. Food shall be prepared by methods that conserve nutritive value, flavor, and appearance, and shall be served at proper temperature. F. Compliance with COMAR 10.15.03 Food Service Facilities. Food service personnel shall comply with Maryland Department of Health COMAR 10.15.03 Food Service Facilities. #### Regulation .21 Housekeeping Services and Pest Control. *COMAR 10.07.12.21* The following shall be observed: A. The building and all its parts shall be kept in good repair, neat, clean, attractive, and safe. Housekeeping shall meet the highest possible standards of hygiene and cleanliness. B. All walls, floors, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a character to permit frequent and easy cleaning. C. The facility shall be kept free of unnecessary accumulations of unused furniture, equipment, linen, clothing, and similar items. D. The facility shall be maintained free of insects, rodents, and harborages, by operation of an active pest-control program, either by use of facility personnel or by contract with a pest-control company. Care shall be exercised in the usage and storage of toxic and flammable insecticides and rodenticides. E. All outside doors, windows, and other outside openings shall be screened with wire screen or its equal of at least 16 meshes per linear inch. ### Chapter 13 — Forensic Residential Centers (FRCs) **Authority:** Health-General Article, §§2-102 and 7-904; Criminal Procedure Article, §3-102; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.06 adopted as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; adopted permanently effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .02B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .04G amended effective January 20, 2014 (41:1 Md. R. 13) #### Regulation .01 Scope. *COMAR 10.07.13.01* This chapter sets forth requirements for a facility to be licensed as a forensic residential center. #### Regulation .02 Definitions. *COMAR 10.07.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Confined” means an order by the court pursuant to Criminal Procedure Article, §3-106(d)(2), Annotated Code of Maryland. (2) “Court-ordered evaluation” means an evaluation ordered by the court under Criminal Procedure Article, §§3-105 and 3-111, Annotated Code of Maryland, to assist the court to determine if an individual is incompetent to stand trial or is not criminally responsible because of mental retardation. (3) “Department” means the Maryland Department of Health. (4) “Evaluation unit” means a part of the forensic residential center dedicated to performing court-ordered evaluations pursuant to Criminal Procedure Article, Title 3, Annotated Code of Maryland. (5) “Forensic residential center (FRC)” means a facility that is: (a) Licensed to provide a continuum of integrative services to individuals with an intellectual disability: (i) Ordered by the court for an evaluation or to be confined; (ii) Court-committed for care or treatment to the Department as incompetent to stand trial or not criminally responsible, who are dangerous as a result of mental retardation; or (iii) On conditional release and returned to the facility either voluntarily or on hospital warrant; (b) A related institution as defined in Health-General Article, §19-301(o), Annotated Code of Maryland; and (c) Not an extended care or comprehensive rehabilitation facility. (6) “Incompetent to stand trial (IST)” has the meaning set forth in Criminal Procedure Article, §3-101(f), Annotated Code of Maryland. (7) “Not criminally responsible (NCR)” means a verdict of not criminally responsible as set forth in Criminal Procedure Article, §3-109, Annotated Code of Maryland. (8) “Qualified developmental disabilities professional (QDDP)” means an individual who coordinates and monitors the delivery of services for individuals with an intellectual disability. (9) “Therapeutic care unit” means an FRC or part of an FRC dedicated to providing care or treatment to individuals who are court-committed or confined. #### Regulation .03 Licensing Procedure. *COMAR 10.07.13.03* A. The Secretary shall license an FRC that meets the requirements of this chapter. B. The license for an FRC shall be effective for 1 year. C. The Secretary may renew the license of an FRC if it continues to meet the requirements of this chapter. D. Approval, Denial, Revocation, and Sanctions. (1) The Secretary may deny an application, suspend, revoke, or impose disciplinary sanctions on the license of an FRC if it fails to comply with the requirements of this chapter. (2) Any action to deny an application, suspend, revoke, or impose sanctions on a license shall be governed by COMAR 10.22.03. #### Regulation .04 Administrative Requirements. *COMAR 10.07.13.04* A. In addition to the requirements of this chapter, an FRC shall comply with the applicable requirements of COMAR 10.22.02. B. Safety and Sanitation. (1) An FRC's grounds, fixtures, and equipment shall: (a) Be maintained in good repair and be clean and attractive; (b) Be free of unnecessary accumulations of personal property or debris; (c) Be free of hazards, insects, and rodents; and (d) Be free from fire hazards. (2) An FRC shall comply with all applicable local fire and building codes and the Maryland State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01. C. Living Space. An FRC shall: (1) Have bedrooms that: (a) Have at least one outside wall; (b) Are equipped with or located near toilet and bathing facilities; (c) Accommodate no more than two individuals, provided such arrangement is clinically appropriate; and (d) Measure at least: (i) 60 square feet per individual in multiple individuals' bedrooms; and (ii) 80 square feet in single individual's bedrooms; (2) Have adequate bathroom facilities and maintain water temperature that does not exceed 110 degrees Fahrenheit in areas where individuals do not demonstrate the capability to regulate water temperature; (3) Provide adequate space and equipment for dining, living, health and therapeutic services, recreation, and other program activities; and (4) Provide that the above described living space be: (a) Dedicated to the sole use of individuals committed for court evaluation or committed or confined pursuant to Criminal Procedure Article, Title 3, Annotated Code of Maryland; and (b) Separate from areas used, frequented, or occupied by individuals committed or admitted pursuant to Health-General Article, Title 10, Annotated Code of Maryland. D. Infection Control. The FRC shall: (1) Establish policies and procedures to investigate, control, and prevent infections in the facility; (2) Ensure that facility staff follows these policies and procedures; and (3) Maintain records of actions taken to address and prevent infections. E. Food Services. The FRC shall employ a qualified dietitian either full-time or part-time, or on a consultant basis at the facility's discretion, who shall: (1) Provide adequate food and nutrition services; (2) Provide individuals with a nourishing, well-balanced diet including modified and specially prescribed diets; (3) Ensure the diet is prepared in accordance with current clinical dietary standards; (4) Ensure individuals receive at least three meals a day, at regular normal meal times; (5) Ensure foods are served in variety, appropriate consistency, texture, quantity, in season, and at appropriate temperatures; and (6) Prepare menus in advance and keep them on file a minimum 30 days. F. Health Care Services. As clinically appropriate, an FRC shall provide health services for all residents including, but not limited to: (1) Physician services, 24 hours a day; (2) Annual physical examinations which include: (a) Vision evaluations; and (b) Hearing evaluations; (3) Immunizations; (4) Laboratory services; (5) Nursing services and delegated nursing services in compliance with COMAR 10.27.11; (6) Medical care or nursing care plans for each individual and reviews of each plan; (7) Dental care; (8) Pharmacy services; and (9) Training or supervision of individuals to: (a) Self administer medications; (b) Perform routine treatments; and (c) Provide for their health care. G. Personnel and Staffing. (1) The administrator of an FRC shall: (a) Ensure appropriate employee health screenings; and (b) Obtain certification that an employee or volunteer is free from tuberculosis in a communicable form only if the employee or volunteer will be involved in the direct care of tuberculosis patients. (2) An FRC shall provide an adequate staffing plan in accordance with COMAR 10.22.02.11 to meet the needs of individuals served. (3) An FRC shall employ a Maryland licensed psychologist as the supervising psychologist who shall: (a) Supervise the evaluation and therapeutic treatment of individuals; (b) Use clinical best practices for the FRC population; (c) Have relevant work experiences and training in conducting and completing functional analyses, assessments, and behavior plans including experience working with individuals with co-occurring diagnoses of mental illness, substance abuse, and an intellectual disability; (d) Train direct care staff to collect data, and implement behavior plans and other programs in the individual's plan; (e) Ensure all services provided are documented appropriately in the individual's record; and (f) Ensure all behavior plans are developed in accordance with COMAR 10.22.10. (4) An FRC shall employ a Maryland licensed physician who: (a) Is certified in psychiatry by the American Board of Psychiatry and Neurology or who has completed the minimum educational and training requirements to be qualified to take the Board examination; and (b) Has the relevant work experience in providing psychiatric services to individuals with an intellectual disability and co-occurring disorders including mental disorders and addiction diseases. (5) An FRC shall employ direct care staff who develop and implement an activity schedule for the individual that includes at a minimum: (a) The individual's preferred activities; (b) Opportunities for recreation and social activities; (c) Times for meals; (d) Training as indicated in the individual's plan; and (e) The individual's waking and bedtime hours. (6) An FRC shall employ a Maryland licensed registered nurse to: (a) Train direct care staff on an individual's nursing care needs and any delegated nursing services; and (b) Ensure all services provided are documented in the individual's plan. (7) The FRC shall have a clinical team that shall include, at a minimum: (a) A Maryland licensed psychologist; (b) A Maryland licensed certified social worker—clinical (LCSW-C); (c) A QDDP; (d) Direct care staff; (e) A Maryland licensed registered nurse; and (f) As necessary: (i) A psychiatrist; (ii) A physician; or (iii) Other licensed staff. H. Security and Restrictions. (1) A resident may have access to personal electronic devices according to the resident's individual plan. (2) A resident may not have access to or possess: (a) Illegal products; (b) Cigarettes, alcohol, or pornography; or (c) Items or objects that the supervising psychologist documents in the individual's record as contraindicated or designates as dangerous to the individual or others. (3) The administrator of an FRC shall ensure a safe and secure setting for individuals by providing: (a) Adequate staffing; (b) Adequate supervision of individuals; (c) Appropriate training for staff to perform their job duties competently; and (d) Designated visitors' rooms with appropriate supervision of individuals during visits as needed. (4) The administrator of an FRC may utilize the following environmental security measures: (a) Security doors and windows; (b) Security screens; (c) Appropriate locks; (d) Alarm systems; (e) Electronic monitoring devices; (f) Video monitoring systems; (g) Outdoor gates and fences with locks; and (h) Enclosed or locked patios. (5) A resident's rights to communications and restrictions of communications are set forth in Health-General Article, §10-702, Annotated Code of Maryland, and adopted herein. I. Emergency Management Plans. The administrator of an FRC shall develop an emergency plan for all types of emergencies and disasters in accordance with COMAR 10.07.20.05E. J. Standing Committee Approval. An FRC shall assure that the quality assurance standing committee reviews all behavioral plans in accordance with COMAR 10.22.02.14E. #### Regulation .05 Enrollment, Release, and Discharge. *COMAR 10.07.13.05* A. All individuals in an FRC are ordered or committed by the court to the Department, or under the court's jurisdiction pursuant to an order of conditional release as set forth in Criminal Procedure Article, Title 3, Annotated Code of Maryland. B. An individual on conditional release who voluntarily agrees to admission to a therapeutic care unit shall be admitted as set forth in the conditional release order. C. Release From an FRC. (1) Individuals court ordered for evaluation shall be released from the evaluation unit as set forth in Criminal Procedure Article, §3-105 or 3-111, Annotated Code of Maryland. (2) Individuals committed as IST or NCR shall be released as set forth in Criminal Procedure Article, Title 3, Annotated Code of Maryland. D. Confined individuals shall be discharged as set forth in Health-General Article, §7-503(e), Annotated Code of Maryland. E. Individuals admitted pursuant to a hospital warrant shall be discharged as set forth in Criminal Procedure Article, §3-121, Annotated Code of Maryland. F. Individuals who voluntarily admit themselves pursuant to a conditional release order shall be discharged as set forth in the conditional release order. #### Regulation .06 Services. *COMAR 10.07.13.06* A. Services provided by an FRC shall include: (1) As set forth in Criminal Procedure, Title 3, Annotated Code of Maryland, all required evaluations and reports; and (2) Therapeutic services designed to prepare the individual for productive community living, that address issues of dangerousness, and are based on an interdisciplinary team assessment considering least restrictive interventions, include but are not limited to: (a) For individuals committed as IST, competency attainment services; and (b) For all individuals, services as set forth in the Individual Plan and, as clinically appropriate, therapeutic services include, but are not limited to: (i) Behavioral and mental health plans and services; (ii) Physical, speech, and occupational therapies; (iii) Habilitation services including vocational, educational, and life skills training; or (iv) Development of an aftercare or services plan. B. Therapeutic services for all individuals shall be conducted in space not simultaneously shared or used with individuals who are not residents of the FRC. ### Chapter 14 — Assisted Living Programs **Authority:** Health-General Article, Title 19, Subtitle 18, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1999 (25:26 Md. R. 1923) **Administrative History:** Regulation .02B amended effective November 1, 1999 (26:22 Md. R. 1692); July 22, 2002 (29:14 Md. R. 1074) **Administrative History:** Regulation .02B amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .03 amended effective August 21, 2000 (27:16 Md. R. 1523) **Administrative History:** Regulation .04 amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .06 amended as an emergency provision effective August 15, 2000 (27:18 Md. R. 1664); amended permanently effective November 27, 2000 (27:23 Md. R. 2147) **Administrative History:** Regulation .06E adopted effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .09B, C amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .12D, E amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .15-1 adopted effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .15-2 adopted effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .17B amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .17E—G adopted effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .21F, K amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .21P adopted effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .26A amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .27C, E amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .28D amended, and E—K adopted, effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Regulation .29B amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .36A amended effective March 29, 2004 (31:6 Md. R. 508); December 19, 2005 (32:25 Md. R. 1941) **Administrative History:** Regulation .46 amended effective March 29, 2004 (31:6 Md. R. 508) **Administrative History:** Regulation .49B amended effective July 22, 2002 (29:14 Md. R. 1074) **Administrative History:** Regulations .01—.53 repealed and new Regulations .01—.64 adopted effective December 29, 2008 (35:26 Md. R. 2249) **Administrative History:** Regulation .07A amended effective August 19, 2013 (40:16 Md. R. 1344); August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .07C amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .13A amended effective June 25, 2012 (39:12 Md. R. 745) **Administrative History:** Regulation .24D amended effective June 25, 2012 (39:12 Md. R. 745) **Administrative History:** Regulation .29 amended effective June 25, 2012 (39:12 Md. R. 745) **Administrative History:** Chapter revised effective April 28, 2025 (52:8 Md. R. 357) #### Regulation .01 Purpose. *COMAR 10.07.14.01* The purpose of this chapter is to set minimum, reasonable standards for licensure of assisted living programs in Maryland. This chapter is intended to maximize independence and promote the principles of individuality, personal dignity, freedom of choice, and fairness for all individuals residing in assisted living programs while establishing reasonable standards to promote individuals’ health and safety. #### Regulation .02 Definitions. *COMAR 10.07.14.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abuse of a Resident. (a) “Abuse of a resident” means physical, sexual, mental, or verbal abuse, or the improper use of a physical or chemical restraint or involuntary seclusion as those terms are defined in this regulation. (b) “Abuse of a resident” does not include: (i) The performance of an accepted medical procedure ordered by a health care practitioner practicing within the scope of their license; (ii) Compliance with a valid advance directive; or (iii) Honoring a resident’s known wishes regarding medical care. (2) Activities of Daily Living. (a) “Activities of daily living” means normal daily activities. (b) “Activities of daily living” includes: (i) Eating or being fed; (ii) Grooming, bathing, and oral hygiene, including brushing teeth, shaving, and combing hair; (iii) Mobility, transfer, ambulation, and access to the outdoors, when appropriate; (iv) Toileting; and (v) Dressing in clean, weather-appropriate clothing. (3) Administration of Medication. (a) “Administration of medication” means the act of preparing and giving a medication to a resident. (b) “Administration of medication” includes: (i) Identifying the time to administer the medication; (ii) Opening the medication container; (iii) Removing the medication from the container; (iv) Giving the medication to the resident. (c) “Administration of medication” does not include residents who have the cognitive ability to recognize their medications but only require assistance such as: (i) A reminder to take the medication; (ii) Physical assistance with opening a medication container; or (iii) Assistance with removing medication from the container. (4) “Adult medical day care” has the meaning stated in Health-General Article, 14-301, Annotated Code of Maryland. (5) “Advance directive” means: (a) A written or electronic document, voluntarily executed by the declarant consistent with the requirements of Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland; or (b) A witnessed oral statement, made by the declarant consistent with the provisions of the Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland. (6) “Alzheimer’s Special Care Unit” means a secured or separated special unit specifically designed for individuals with any type of dementia, including a probable or confirmed diagnosis of Alzheimer’s disease and related dementias. (7) “Assessment” means a process of evaluating an individual’s health, functional and psychosocial history, and condition using the Resident Assessment Tool. (8) “Assist rail” means a hand rail or other similar, substantially constructed device that is installed to enable residents to move safely from one point or position to another. (9) “Assisted living manager” means the individual who is: (a) Designated by an assisted living program to oversee the overall and day-to-day operation of the assisted living program; and (b) Responsible for the duties set forth in Regulation .15 of this chapter. (10) Assisted Living Program. (a) “Assisted living program” means a residential or facility-based program for two or more residents that provides housing and supportive services, supervision, personalized assistance, health-related services, or a combination of these services to meet the needs of individuals who are unable to perform, or who need assistance in performing, the activities of daily living or instrumental activities of daily living, in a way that promotes optimum dignity and independence for the individuals. (b) “Assisted living program” does not include: (i) A nursing facility, as defined under Health-General Article, §19-301, Annotated Code of Maryland; (ii) A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland; (iii) A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland; (iv) A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland; (v) Services provided by family members; (vi) Services provided by a licensed residential service agency or licensed home health agency in an individual’s own home; or (vii) A Certified Adult Residential Environment Program that is certified by the Department of Human Services under Human Services Article, §§6-508—6-513, Annotated Code of Maryland. (11) “Authorized prescriber” means an individual who is authorized to prescribe medications under Health Occupations Article, Annotated Code of Maryland. (12) “Background check” means a check of court and other records by a private agency. (13) “Bank” means a bank, trust company, savings bank, savings and loan association, or financial institution that is: (a) Authorized to do business in this State; and (b) Insured by the Federal Deposit Insurance Corporation. (14) “Certified medication technician” means an individual who is certified as a medication technician by the Maryland Board of Nursing under COMAR 10.39.04. (15) “Chemical restraint” means controlling behavior by use of a drug that is not otherwise required to treat medical symptoms. (16) Cognitive Impairment. (a) “Cognitive impairment” means the loss of those thought processes that orchestrate relatively simple ideas, movements, or actions into goal-directed behavior. (b) “Cognitive impairment” includes lack of judgment, planning, organization, self-control, and the persistence needed to manage normal demands of the individual’s environment. (17) “Common ownership community” means: (a) A condominium organized under Real Property Article, Title 11, Annotated Code of Maryland; (b) A homeowners association organized under Real Property Article, Title 11B, Annotated Code of Maryland; or (c) A cooperative housing corporation organized under Corporations and Associations Article, Title 5, Subtitle 6B, Annotated Code of Maryland. (18) “Common-use telephone” means a telephone that is: (a) Within the facility; (b) Accessible to residents; (c) Located so that residents can have private conversations; and (d) Available to residents to make free local calls. (19) “Consultant” means an individual or organization, under contract with a licensee, that may: (a) Have partial or full responsibility and control over one or more areas of operations of the assisted living provider; and (b) Provide expertise related to: (i) One or more licensure requirements; or (ii) Standards of care. (20) “Contact precautions” means the use of a private room, if available, and appropriate personal protective equipment, such as gowns, gloves, or masks to prevent the transmission of certain organisms between an infected individual and others. (21) “Controlled dangerous substance (CDS)” means a medication or substance listed in Schedule I through Schedule V as defined in Criminal Law Article, §5-101, Annotated Code of Maryland. (22) “Criminal history records check” means a check of criminal history information, as defined in Criminal Procedure Article, §10-201, Annotated Code of Maryland, by the Department of Public Safety and Correctional Services. (23) “Delegating nurse” means a nurse who: (a) Is licensed to practice registered nursing in this State as defined in Health Occupations Article, Title 8, Annotated Code of Maryland; and (b) Has successfully completed the Board of Nursing’s approved training program for registered nurses, delegating nurses, and case managers in assisted living. (24) “Delegation of nursing tasks” means the formal process approved by the Maryland Board of Nursing which permits a professional nurse to assign nursing tasks to an unlicensed individual, a certified nursing assistant, or a medication technician, in accordance with COMAR 10.27.11.03, through: (a) A nursing assessment of the patient’s nursing care needs prior to delegation of tasks; (b) Instructing the unlicensed individual, certified nursing assistant, or medication technician, or verifying their competency; (c) Supervising of the delegated task in accordance with COMAR 10.27.11.04; (d) Retaining accountability and responsibility for the delegated task; (e) Evaluating the performance of the delegated task; and (f) Assuring accurate documentation of outcomes on the nursing record. (25) “Department” means the Maryland Department of Health. (26) “Discharge” means releasing a resident from an assisted living program, after which the releasing program no longer is responsible for the resident’s care. (27) “Emergency admission” means the temporary admittance of an individual in an assisted living program when the individual’s health and safety would be jeopardized by not permitting immediate admittance. (28) “Emergency Medical Services form” means a form issued by the Maryland Institute for Emergency Medical Services Systems for the purpose of documenting emergency medical services and do not resuscitate orders as defined in Health-General Article, §5-601(k), Annotated Code of Maryland, including a Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form. (29) Facilitating Access. (a) “Facilitating access” means: (i) Making appropriate referrals for care and treatment; (ii) Arranging for the appointment and involvement of appropriate health care decision makers, when necessary; and (iii) Facilitating contact between the resident, the resident representative, the health care or social service professional, and needed services. (b) “Facilitating access” does not mean guaranteeing payment for services that are not: (i) Covered by the resident agreement; or (ii) Paid for by the resident or the resident agent. (30) “Facility” means the physical plant in which an assisted living program is operated. (31) “Family” means a group of two or more individuals related by legal status or affection who consider themselves a family. (32) “Family council” means a group of individuals who work together to protect the rights of and improve the quality of life for residents of an assisted living program. (33) “Financial exploitation” means the misappropriation of a resident’s assets or income, including: (a) Spending the resident’s assets or income against the will of or without the consent of the resident or the resident agent; (b) Spending the resident’s assets or income for the use and benefit of a person other than the resident, if the resident or resident agent has not consented to the expenditure; or (c) The resident agent’s misappropriation of the resident funds. (34) “Frequent” means occurring or appearing quite often or at close intervals, but not continuously. (35) “Health care practitioner” means a physician, a certified nurse practitioner, or a physician assistant who provides health care services and is licensed under Health Occupations Article, Annotated Code of Maryland. (36) “Health condition” means the status of a resident’s physical, mental, and psychosocial well-being. (37) “Home health services” means those services provided as defined in Health-General Article, §§19-401—19-410 or §§19-4A-01—19-4A-10, Annotated Code of Maryland. (38) “Household member” means an individual living in an assisted living program who is not a resident or staff member. (39) “Incident” means: (a) The death of a resident from other than natural causes; (b) The disappearance or elopement of a resident; (c) An assault on a resident resulting in injury; (d) An injury to a resident which may require treatment by a health care practitioner, or an event such as a fall which could subsequently require treatment; (e) Abuse, neglect, or financial exploitation of a resident; (f) An error or omission in medication or treatment which may result in harm to the resident; (g) An emergency situation or natural disaster; or (h) Any other event that results in death, permanent harm, or severe temporary harm. (40) “Informal dispute resolution (IDR)” means an informal process that provides an assisted living program the opportunity to dispute one or more deficiencies cited in a written statement of deficiencies issued by the Department or the Department’s designee related to a recent survey. (41) “Instrumental activities of daily living” means home management skills, such as shopping for food and personal items, preparing meals, or handling money. (42) “Intensive” means highly concentrated. (43) “Intermittent nursing care” means nursing care which is provided episodically, irregularly, or for a limited time period. (44) Involuntary Seclusion. (a) “Involuntary seclusion” means the separation of a resident from others or from the resident’s room or confinement to the resident’s room with or without roommates, against the resident’s will or the will of the resident representative. (b) “Involuntary seclusion” does not mean separating a resident from other residents on a temporary and monitored basis. (45) “Lavatory” means a basin used to maintain personal cleanliness that has hot and cold running water and sanitary drainage. (46) “Law enforcement agency” means the Maryland State Police or a police agency of a county or municipal corporation. (47) “License” means a document issued by the Secretary to operate an assisted living program in the State. (48) “Licensed pharmacist” means an individual who is authorized to practice pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland. (49) “Licensed physician” means an individual who is authorized to practice medicine under Health Occupation Article, Title 14, Annotated Code of Maryland. (50) “Licensee” means the person to whom a license is issued. (51) “Management firm” means an organization, under contract with an applicant for a license or a current licensee, that is intended to have or has full responsibility and control over the day-to-day operations of the assisted living program. (52) “Medical Orders for Life-Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health-General Article, §5-608.1, Annotated Code of Maryland. (53) “Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland. (54) Mental Abuse. (a) “Mental abuse” means an intentional course of conduct resulting in or intended to produce emotional harm. (b) “Mental abuse” does not include the performance of an accepted clinical or medical procedure. (55) “Minimal” means the least amount required to produce the desired result. (56) “Neglect” means depriving a resident of adequate food, clothing, shelter, supervision, essential medical treatment, or essential rehabilitative therapy. (57) Nursing Overview. (a) “Nursing overview” means a process by which a registered nurse assures that the health and psychosocial needs of the resident are met. (b) “Nursing overview” includes: (i) Observation; (ii) Assessment; (iii) Staff education; and (iv) The development, implementation, and evaluation of a resident’s service plan. (58) “Occasional” means occurring from time to time, on an infrequent or irregular basis, with no particular pattern. (59) “Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health. (60) “Ongoing” means continuing over an extended period of time. (61) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (62) “Personal representative” means an individual appointed by the court with the duties and authority to settle and distribute the estate of the decedent consistent with Estates and Trusts Article, §7-401, Annotated Code of Maryland. (63) “Physical abuse” means the sustaining of any physical injury or pain to a resident as a result of cruel or inhumane treatment, or as a result of a malicious act by any individual. (64) Physical Restraint. (a) “Physical restraint” means the use of a device or physical action to prevent, suppress, or control head, body, or limb movement that cannot be readily and easily removed by the resident. (b) “Physical restraint” does not mean a protective device as defined in this regulation. (65) “Plan of correction” means a written response from the assisted living program that addresses how each deficiency cited as a result of a survey by the Department or the Department’s designee will be corrected. (66) “Protective device” means any device or equipment, except bedside rails: (a) That: (i) Shields a resident from self-injury; (ii) Prevents a resident from aggravating an existing physical problem; or (iii) Prevents a resident from precipitating a potential physical problem; (b) That may limit, but does not eliminate, the movement of the resident’s head, body, or limbs; and (c) That is prescribed by a health care practitioner. (67) “Quality assurance” means a system for maintaining professionally acceptable standards of care by: (a) Identifying opportunities to improve; (b) Studying problems, if any, and their root causes; and (c) Implementing and monitoring interventions to ensure the intended improvement is achieved and sustained. (68) “Relief personnel” means qualified individuals who have been hired to substitute for certain staff members: (a) In emergency situations; or (b) When the assisted living manager or other staff is absent from the assisted living program for extended hours. (69) “Resident” means an individual 18 years old or older who requires assisted living services. (70) “Resident agent” means a person who manages, uses, or controls the funds or assets that legally may be used to pay an applicant’s or resident’s share of the costs or other charges for assisted living services. (71) “Resident agreement” means a document signed by both the resident or the resident agent and the assisted living manager, or designee, stating the terms that the parties agree to, including, at a minimum, the provisions set forth in Regulations .26 and .27 of this chapter. (72) “Resident Assessment Tool” means Maryland’s Assisted Living Resident Assessment and Level of Care Scoring Tool that is: (a) Developed by the OHCQ with input from assisted living program staff; and (b) Used by assisted living programs to assess the current health, physical, and psychosocial status of prospective and current residents. (73) Resident Representative. (a) “Resident representative” means a person referenced in Regulation .35 of this chapter. (b) “Resident representative” does not include an assisted living program owner or employee that has been designated as a representative payee for a resident. (74) Restraint. (a) “Restraint” means any chemical restraint or physical restraint as defined in §B(15) and (64) of this regulation. (b) “Restraint” does not include a protective device. (75) “Sanction” means a disciplinary penalty imposed for a violation of statutes or regulations relating to the operation of an assisted living program, including, but not limited to, those penalties referenced in Regulations .58, .59, .61, .63, and .64 of this chapter. (76) “Secretary” means the Secretary of Health or the Secretary’s designee. (77) “Self-administration of medication” means a resident having the cognitive and physical ability to take medication as prescribed by an authorized prescriber: (a) At the correct time; (b) By the correct route; and (c) In the correct dosage. (78) “Service plan” means a written plan developed by an assisted living program in conjunction with the resident and the resident representative, if appropriate, which identifies, among other things, services that the assisted living program will provide to the resident based upon the resident’s needs as determined by the Resident Assessment Tool. (79) “Sexual abuse” means a crime listed in Criminal Law Article, Title 3, Subtitle 3, Annotated Code of Maryland. (80) “Short-term residential care” means a stay, either continuous or intermittent, in an assisted living program of not more than 30 consecutive days from the date of initial admission, which cannot exceed 180 days per year. (81) Significant Change of Condition. (a) “Significant change of condition” means a shift in a resident’s health, functional, cognitive, behavioral, or psychosocial conditions that either causes an improvement or deterioration in a resident’s condition as described in the Resident Assessment Tool. (b) “Significant change of condition” does not include any ordinary, day-to-day fluctuations in health status, function, or behavior, or an acute short-term illness, such as a cold, unless these fluctuations continue to recur. (82) “Staff” means supervisors, assistants, aides, or other employees, including independent contractors retained by an assisted living program, to provide the care and services required by this chapter. (83) “Standard precautions” means a set of infection control practices used to prevent transmission of diseases that can be acquired by contact with blood, body fluids, non-intact skin (including rashes), and mucous membranes. (84) “Substantial” means considerable in importance, degree, amount, frequency, or extent. (85) “Trauma-informed approach” means an approach to care delivery that: (a) Recognizes the widespread impact and signs and symptoms of trauma in residents; and (b) Incorporates knowledge about trauma into care plans, policies, procedures, and practices to avoid re-traumatization. (86) “Trauma-informed care” means an approach to delivering care that involves understanding, recognizing and responding to the effects of all types of trauma. (87) “Treatment” means medical or psychological management to cure, slow the progression of, maintain, or improve a disease or condition. (88) “Unclaimed deceased resident” means a resident of an assisted living program: (a) Who has not prearranged and prepaid for the disposal of the resident’s body; or (b) For whom no individual has claimed the body and assumed funeral or burial responsibility. (89) “Verbal abuse” means the use of any oral or gestured language that includes disparaging or derogatory terms, which is directed to a resident, or within a resident’s hearing distance, regardless of the resident’s age, ability to comprehend, or disability. #### Regulation .03 Incorporation by Reference. *COMAR 10.07.14.03* In this chapter, the following documents are incorporated by reference: A. Centers for Disease Control and Prevention (CDC) Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, 2005, which is incorporated by reference in COMAR 10.07.02.02; B. National Fire Protection Association (NFPA) 101 Life Safety Code (2018 Edition), which is incorporated by reference in COMAR 29.06.01.06; and C. The State Fire Prevention Code, which is incorporated by reference in COMAR 29.06.01. #### Regulation .04 License Required. *COMAR 10.07.14.04* A. A person may not operate an assisted living program in the State without obtaining a license from the Secretary and complying with the requirements of this chapter. B. Providing housing under a landlord-tenant arrangement does not, in and of itself, exclude a person from the licensure requirements of this chapter. C. Separate licenses are required for assisted living programs that are maintained on the same or separate premises, even though the programs are operated by the same person. D. The Secretary shall issue a license for a specified number of beds and a specified level of care. E. An assisted living program may not provide services beyond its licensed authority by: (1) Providing care to more residents than the total number of licensed beds; or (2) Providing care beyond the specified level of care without first obtaining written approval of a resident-specific waiver request from the Department. F. The number of residents, as stated in §E of this regulation, includes: (1) Residents in the facility; (2) Individuals admitted to the assisted living program for short-term residential care; (3) Family members who are cared for by assisted living program staff; and (4) Individuals who are transitioning to the assisted living program. G. An assisted living program shall conspicuously post its license in a common-use area at the facility. H. A person who falsifies or alters an assisted living program license shall be subject to referral for a criminal prosecution and imposition of civil fines, as specified in Regulations .57—.65 of this chapter. #### Regulation .05 Levels of Care. *COMAR 10.07.14.05* A. An assisted living program may provide: (1) The level of care for which the assisted living program has been approved; and (2) Any lower level of care. B. At the time of initial licensure, an applicant shall: (1) Request approval to provide services at one of the three levels of care set forth in §G of this regulation; and (2) Demonstrate that the assisted living program has the capacity to provide the level of care requested either directly or through the coordination of community services. C. If, at any time, an assisted living program wants to provide a higher level of care than that for which it is licensed, the assisted living program shall request authority from the Department to change its licensed level of care. D. The Department shall determine if an applicant or the assisted living program has the capacity to provide and ensure the requested level of care. E. The Department may approve or deny the request. F. If an applicant or an assisted living program is aggrieved by the Department’s decision, the applicant or the assisted living program may appeal by filing a request for a hearing consistent with Regulation .65 of this chapter. G. Levels of Care. (1) The applicant or assisted living program shall: (a) Request one of the levels of care listed below; and (b) Have sufficient staff and the abilities necessary to provide the level of care selected. (2) Level 1: Low Level of Care. (a) Health and Wellness. Staff shall have the ability to: (i) Recognize the causes and risks associated with a resident’s current health condition once these factors are identified by a health care practitioner; and (ii) Provide occasional assistance in accessing and coordinating health services and interventions. (b) Functional Condition. Staff shall have the ability to provide occasional supervision, assistance, support, setup, or reminders with two or more activities of daily living. (c) Medication and Treatment. Staff shall have the ability to assist a resident with taking medication or to coordinate access to necessary medication and treatment. (d) Behavioral Condition. Staff shall have the ability to monitor and provide uncomplicated intervention to manage occasional behaviors that are likely to disrupt or harm the resident or others. (e) Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage occasional psychological or psychiatric episodes or fluctuations that require uncomplicated intervention or support. (f) Social and Recreational Interests. Staff shall have the ability to provide occasional assistance in accessing social and recreational services. (3) Level 2: Moderate Level of Care. (a) Health and Wellness. Staff shall have the ability to: (i) Recognize and accurately describe and define a resident’s health condition and identify likely causes and risks associated with the resident’s condition; and (ii) Provide or ensure access to necessary health services and interventions. (b) Functional Condition. Staff shall have the ability to provide or ensure: (i) Substantial support with two or more activities of daily living; or (ii) Minimal support with any number of activities of daily living. (c) Medication and Treatment. Staff shall have the ability to: (i) Provide or ensure assistance with taking medication; or (ii) Administer necessary medication and treatment, including monitoring the effects of the medication and treatment. (d) Behavioral Condition. Staff shall have the ability to monitor and provide or ensure intervention to manage frequent behaviors which are likely to disrupt or harm the resident or others. (e) Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage frequent psychological or psychiatric episodes that may require limited skilled interpretation, or prompt intervention or support. (f) Social and Recreational Interests. Staff shall have the ability to provide or ensure ongoing assistance in accessing social and recreational services. (4) Level 3: High Level of Care. (a) Health and Wellness. Staff shall have the ability to: (i) Recognize and accurately describe and define a resident’s health condition and identify likely causes and risks associated with the residents’ condition; and (ii) Provide or ensure ongoing access to and coordination of comprehensive health services and interventions, including nursing overview. (b) Functional Condition. Staff shall have the ability to provide or ensure comprehensive support as frequently as needed to compensate for any number of activities of daily living deficits. (c) Medication and Treatment. Staff shall have the ability to: (i) Provide or ensure assistance with taking medication; and (ii) Administer necessary medication and treatment, including monitoring or arranging for monitoring of the effects of complex medication and treatment regimens. (d) Behavioral Condition. Staff shall have the ability to monitor and provide or ensure ongoing therapeutic intervention or intensive supervision to manage chronic behaviors which are likely to disrupt or harm the resident or others. (e) Psychological or Psychiatric Condition. Staff shall have the ability to monitor and manage a variety of psychological or psychiatric episodes involving active symptoms, condition changes, or significant risks that may require skilled interpretation or immediate interventions. (f) Social and Recreational Interests. Staff shall have the ability to provide or ensure ongoing access to comprehensive social and recreational services. #### Regulation .06 Restrictions. *COMAR 10.07.14.06* A. Restricted Nomenclature. An assisted living program licensed under this chapter may not use in its title or advertising the words “hospital”, “sanitarium”, “nursing”, “convalescent”, “rehabilitative”, “sub-acute”, or “hospice”. B. Advertising an Assisted Living Program. (1) Prohibited Terms. A person operating an assisted living program may not use the term “assisted living” in its advertising without being licensed as an assisted living program by the Department. (2) Misleading or False Advertising. (a) A person may not advertise, represent, or imply to the public that an assisted living program is authorized to provide a service that the program is not licensed, certified, or otherwise authorized by the Department to provide when the license, certificate, or authorization is required under this chapter. (b) A person may not advertise an assisted living program in a misleading or fraudulent manner. (c) The Department shall report misleading or false advertising to the Office of the Attorney General, Division of Consumer Protection. C. Drop-In or Day Services. (1) An assisted living program may not provide day, partial, or hourly adult day care services without appropriate adult medical day care licensure. (2) An individual who has applied for admission or who has been admitted to the assisted living program may, for a reasonable period of time not to exceed 30 calendar days, transition to the program in increments of partial days before becoming a resident. (3) All regulations of this chapter apply to services and care provided during this transition period. (4) An individual who has applied for admission or who has been admitted to the licensee who is transitioning to the assisted living program is counted as a resident. D. Dual Licensure. An assisted living program dually licensed as an adult medical day care program or any other licensed program shall meet all requirements for both programs. E. A person who falsifies or alters an assisted living license shall be subject to referral for criminal prosecution and imposition of civil fines. F. Disclosure of Ownership. An assisted living owner shall disclose any ownership of an adult medical day care center to an assisted living resident prior to referring the resident to the center. #### Regulation .07 Licensing Procedure. *COMAR 10.07.14.07* A. Application for License. (1) To obtain and maintain a license, an applicant shall meet all of the requirements of: (a) This chapter; (b) Other applicable federal, State, and local laws and regulations; and (c) Health-General Article, §19-311, Annotated Code of Maryland, if the program provides services to 17 or more residents. (2) An applicant shall submit: (a) An application on a written or electronic form developed by the Department; (b) The completed Uniform Disclosure Statement on a form developed by the Department; and (c) All other reasonable documents as required by the Department. (3) At a minimum, the applicant shall provide: (a) Verification that the applicant or corporate representative is 21 years old or older; (b) Documentation of any prior denial, suspension, or revocation of a license or certification to provide care to third parties; (c) Identification of any individual or corporate owner of 25 percent or more interest in the assisted living program; (d) Documentation of any conviction and current background check or criminal history records check of the owner, the applicant, the assisted living manager, the alternate assisted living manager, other staff, and any household member; (e) Ownership information as specified on an addendum to the application; (f) Verification that the facility is owned, leased, or otherwise under the control of the applicant; (g) The level of care to be provided by the assisted living program, its location, and the name of the proposed assisted living manager; (h) Documentation of zoning approval, if zoning approval is required by the local jurisdiction in which the assisted living program will be located; and (i) Where applicable, approvals from the local health department, local or State fire authority, and local area agency on aging. B. Additional Requirements for Initial Licensure. The Secretary shall require an applicant for initial licensure to submit: (1) Information concerning any license or certification held by the applicant under Health Occupations Article or Health-General Article, Annotated Code of Maryland, including the prior or current operation by the applicant of a health care facility or similar health care program; (2) Information demonstrating financial or administrative ability to operate an assisted living program in compliance with this chapter, which shall include a business plan and 1-year operating budget; (3) Policies and procedures to be implemented as designated in the application for licensure; and (4) Other reasonably relevant information, if required by law or local jurisdiction, such as: (a) Verification of Workers’ Compensation insurance; (b) Facility plan review documentation; (c) Food service permit; and (d) Rental license. C. License Suspension or Revocation. (1) The owner, assisted living manager, alternate assisted living manager, or board member of an assisted living program that has had its license suspended or revoked by the Department may not own, operate, lease, or manage another assisted living program for 10 years from the date the license was suspended or revoked without good cause shown. (2) After 10 years, the applicant shall submit evidence to the Department that the applicant is capable of owning, managing, or operating an assisted living program. D. Sanctions and Uncorrected Deficiencies. (1) If an owner, assisted living manager, or alternate assisted living manager of an assisted living program operates, leases, or manages an assisted living program that has had sanctions imposed or deficiencies cited within the past 3 years and has not corrected the deficiencies which present a risk to the health or safety of residents for a currently licensed assisted living program, that owner, assisted living manager, or alternate assisted living manager may not apply to open an additional assisted living program until those deficiencies have been corrected as approved by the Department. (2) The Department may not approve a license application for an assisted living program if the owner, assisted living manager, or alternate assisted living manager operates, leases, or manages a licensed assisted living program that has uncorrected deficiencies. (3) In making a determination about a pending assisted living program license application, the Department may consider any sanctions or uncorrected deficiencies that were imposed before or after the application submission which present a risk to the health or safety of residents for a currently licensed assisted living program that is operated, leased, or managed by an owner, assisted living manager, or alternate assisted living manager in the pending license application. E. Violations and Criminal Convictions. (1) The Department reserves the right to deny licensure to an applicant based on the owner’s, assisted living manager’s, or alternate assisted living manager’s prior: (a) History of violations of assisted living regulations; (b) Criminal history that the Department determines may be potentially harmful to residents; (c) Convictions as described in 42 U.S.C. §1320a–7(a) or Criminal Law Article, §14-101, Annotated Code of Maryland; and (d) History of final actions of a Health Occupations Board. (2) In making a determination about a license application, the Department shall consider the following factors related to a criminal conviction: (a) The age at which the crime was committed; (b) The circumstances surrounding the crime; (c) The length of time that has passed since the crime; and (d) Subsequent work history. (3) In making a determination about a license application, the Department shall consider the following factors related to a violation of assisted living regulations: (a) The circumstances surrounding the violation; (b) The length of time since the violation occurred; (c) The scope of the violation; (d) The severity of the violation; and (e) The implementation of a plan of correction. (4) The Department shall consider other evidence that demonstrates whether the applicant poses a threat to the health or safety of residents in an assisted living program. F. Determination of License Application. (1) Based on information provided to the Department by the applicant and the Department’s own investigation, the Secretary shall: (a) Approve the application unconditionally; (b) Approve the application conditionally, which may include, among other conditions, requiring the applicant to use the services of a management firm approved by the Secretary; or (c) Deny the application. (2) The Secretary may not require use of a management firm for a period in excess of 24 months. (3) A person may not: (a) Operate an assisted living program until a provisional license or license has been issued; or (b) Operate multiple sites until each site has been inspected and approved by the Department. (4) A person aggrieved by a decision of the Secretary under this section to deny a license application may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .65 of this chapter. G. Provisional Licenses for Less than 1 Year. The Department may issue a provisional license if: (1) An assisted living program is not in full compliance with this chapter; (2) The Department determines that the noncompliance does not constitute a safety or health hazard; and (3) The applicant or assisted living program has submitted a plan of correction acceptable to the Department which satisfactorily addresses the correction of each deficiency within a time frame acceptable to the Department. H. License Application Administratively Closed. (1) An application is not complete until the Department has received the completed license application and all required documents. (2) After 180 calendar days from the date of initial receipt, the Department may deem an incomplete license application inactive and administratively close the application. (3) An applicant whose application is administratively closed may reapply for a license by submitting a new application. #### Regulation .08 Changes in an Assisted Living Program that Affect the Operating License. *COMAR 10.07.14.08* A. General Information Related to Licensure. (1) A licensee shall immediately notify the Department of any change in the information the licensee had submitted with the most recent application. (2) A license is valid only in the name of the licensee to whom it is issued, and is not subject to sale, assignment, or other transfer. (3) A license is valid only for the premises for which it was originally issued. (4) A licensee shall forward to the Department a copy of any report or citation of a violation of any applicable building codes, sanitary codes, fire safety codes, or other regulations affecting the health, safety, or welfare of residents within 7 calendar days of receipt of the report or citation. An assisted living program’s failure to notify the Department may result in the imposition of a sanction. B. Increase in Licensed Beds. (1) An assisted living program may not provide assisted living services to more residents than the number of beds approved in writing by the Department. (2) To request an increase in the number of beds, a licensed assisted living program shall: (a) Submit the request for an increase in licensed beds on the form developed by and in the manner established by the Department; and (b) Attach the required documents, including, at a minimum, proof of compliance with all local requirements for fire safety, use and occupancy, and zoning permits. (3) If approved, the Department shall issue a new license to the assisted living program that includes the approved number of beds. (4) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. C. Increase in Level of Care. (1) An assisted living program may not provide a higher level of care for residents than is approved by the Department unless a specific resident has a waiver to receive a higher level of care. (2) To request an increase in the level of care, an assisted living program shall: (a) Submit the request for an increase in the level of care on the form developed by and in the manner established by the Department; and (b) Attach supporting documentation, including any changes in staffing, training, or policies and procedures. (3) If approved, the Department shall issue a new license to the assisted living program that includes the approved level of care. (4) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. D. Name Change. (1) An assisted living program shall have a revised license from the Department to change its name or the name under which the program is doing business. (2) To request a name change, an assisted living program shall: (a) Submit the request for a name change on the form developed by and in the manner established by the Department; and (b) Attach the required attachments, including a letter of good standing from the Maryland State Department of Assessments and Taxation (SDAT) Business Express. (3) Upon processing, the Department shall issue a new license to the assisted living program that includes the new name of the licensee. (4) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. E. Change of Location. (1) Prior to operating an assisted living program at a new location, the applicant shall have an assisted living program license issued by the Department. (2) To request an assisted living program license for a new location, an applicant shall: (a) Submit an application for an assisted living program license on the form developed by and in the manner established by the Department; and (b) Submit all required attachments. (3) An assisted living program shall notify the Department in writing of a relocation: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (4) An assisted living program shall notify residents and resident representatives in writing of a relocation: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (5) If approved, the Department shall issue a license to the assisted living program at the new location. (6) Upon receipt of a new license, all use of the previously issued assisted living program license shall cease. F. Change of Ownership — Sale, Transfer, or Lease of a Facility. (1) If a sale, transfer, or lease of a facility causes a change in the person or persons who control or operate the assisted living program, the assisted living program shall be considered a new program and the new owner shall apply for a license and conform to all regulations applicable at the time of transfer of operations. (2) The transfer of any stock which results in a change of the person or persons who control the program or the transfer of any stock in excess of 25 percent of the outstanding stock, constitutes a sale. (3) For the purposes of Life Safety Code enforcement, the program is considered an existing facility if it has been in continuous use as an assisted living program. (4) An assisted living program shall notify the Department in writing of a change of ownership, sale, transfer, or lease of a facility: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (5) An assisted living program shall notify residents and resident representatives in writing of a change of ownership, sale, transfer, or lease of a facility: (a) Within 60 calendar days in advance of the effective date if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the effective date if licensed for 50 or more beds. (6) If a change of ownership of the assisted living program is occurring, the new owner shall: (a) Submit an application for an assisted living program license on the form developed by and in the manner established by the Department; and (b) Submit all required attachments. (7) If approved, the Department shall issue a license to the assisted living program. (8) Upon receipt of a new license, all use of the previously issued assisted living licensee shall immediately cease. (9) A licensee named in the original license shall remain responsible for the operation of the assisted living program until a new license is issued to the new owner, and the current licensee shall remain responsible for correction of all outstanding deficiencies or impending sanctions until a new license is issued to the new owner. G. Voluntary Closure. (1) An assisted living program shall notify the Department of any intention to voluntarily close: (a) Within 60 calendar days in advance of the closure if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the closure if licensed for 50 or more beds. (2) The assisted living program shall include the following information in the notice to the Department: (a) The method for informing residents and resident representatives of its intent to close, change ownership, change location, or sell its assisted living program; and (b) The actions the assisted living program will take to assist residents in securing comparable housing and assistance, if necessary. (3) An assisted living program shall notify residents and resident representatives of a voluntary closure, in writing: (a) Within 60 calendar days in advance of the closure if licensed for 49 or fewer beds; or (b) Within 75 calendar days in advance of the closure if licensed for 50 or more beds. (4) The assisted living program shall provide at least weekly updates to the OHCQ, including: (a) Number of residents remaining in the facility; (b) Number of residents with plans for relocation; and (c) Number of residents with no plans for relocation. (5) In addition to the notice to the Department required by §B of this regulation, after a program closes, the assisted living program shall: (a) Notify the Department of the date of closure and the place of relocation of each resident; and (b) Cease all use of the previously issued assisted living program license. H. Voiding of License. (1) Maryland State Department of Assessments and Taxation (SDAT). (a) A licensed assisted living program shall remain in good standing with (SDAT). (b) If the assisted living program fails to return to good standing 60 calendar days after receipt of notification of noncompliance from SDAT or another government agency, the Department may void the assisted living program’s license. (2) Ceases the Provision of Services. (a) A license is void if the assisted living program ceases to provide services to residents for a period of 180 consecutive days. (b) The owner shall immediately cease all use of the previously issued assisted living program license when the license is voided. I. Surrender of License. (1) Unless the Department agrees to accept the surrender of a license, an assisted living program may not surrender a license to operate an assisted living program nor may the license lapse by operation of law while the licensee is under investigation or while charges are pending against the licensee. (2) The Department may set conditions on its agreement with the licensee under investigation or against which charges are pending to accept surrender of the license. #### Regulation .09 Licensure Standards Waiver. *COMAR 10.07.14.09* A. The Department may grant an assisted living program a waiver from the licensure requirements of this chapter with or without conditions. B. The Department may not, however, grant a waiver from the requirements of Regulation .23A of this chapter. If, however, two individuals having a long-term or otherwise significant relationship wish to be admitted to a program in order to reside in the program together, and one of the individuals requires care as defined in Regulation .23A of this chapter, the Department may grant a waiver consistent with the process established in Regulation .24 of this chapter. C. Application for Licensure Standards Waiver. (1) An assisted living program shall submit a request for a waiver under this regulation on a form developed and in the manner established by the Department. (2) The requestor shall provide in writing the: (a) Regulation from which a waiver is sought; (b) Reason the assisted living program is unable to comply with the regulation; (c) Reason that compliance with the regulation will impose a substantial hardship; and (d) Reason that a waiver will not adversely affect residents. D. Evaluation of Application for Licensure Standards Waiver. In evaluating a waiver request submitted under this regulation, the Department shall review the statements in the application, and may: (1) Inspect the assisted living program; (2) Confer with the assisted living manager or designee; or (3) Discuss the request with residents or their representatives to determine whether they believe a waiver is in the residents’ best interest. E. Grant or Denial of Licensure Standards Waiver. (1) The Department may grant a waiver request if it determines that: (a) Compliance with the regulation from which the waiver is sought cannot be accomplished without substantial hardship; and (b) A waiver will not adversely affect residents. (2) If the Department determines that the conditions of §E(1) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed. F. Written Decision. (1) The Department shall issue and mail to the applicant a final written decision on a waiver request submitted under §A of this regulation within 45 calendar days from receipt of the request and all appropriate supporting information. (2) If the Department grants the waiver, the written decision shall include the waiver’s duration and any conditions imposed by the Department. G. If an assisted living program violates any condition of the waiver, or if it appears to the Secretary that the health or safety of residents residing in the assisted living program will be adversely affected by the continuation of the waiver, a waiver may be revoked. The revocation of a waiver may not be appealed. #### Regulation .10 Uniform Disclosure Statement. *COMAR 10.07.14.10* A. When an assisted living program changes the services reported on its Uniform Disclosure Statement filed with the Department under Regulation .07A(2)(b) of this chapter, the program shall file an amended Uniform Disclosure Statement with the Department within 30 calendar days of the change in services. B. If an individual requests a copy of an assisted living program’s Uniform Disclosure Statement, the assisted living program shall provide a copy of the Uniform Disclosure Statement on a form provided by the Department without cost to the individual making the request. C. An assisted living program shall provide a copy of the current Uniform Disclosure Statement to individuals as part of the program’s marketing materials. #### Regulation .11 Investigation by Department. *COMAR 10.07.14.11* A. Assisted Living Program to Be Open for Inspection. (1) An assisted living program operated by a licensee, and any premises proposed to be operated as an assisted living program, shall be open at all times to announced or unannounced inspections by the Department and by any agency designated by the Department. (2) Any part of the facility, and any surrounding accessory buildings which may be entered by staff or residents, are considered part of the facility and are subject to inspection. (3) An assisted living program and any premises proposed to be operated as an assisted living program may not deny access to the Department or any agency designated by the Department. (4) At all times, the staff on duty at an assisted living program shall know how to contact the assisted living manager, alternate assisted living manager, delegating nurse, and alternate delegating nurse. B. Records and Reports. (1) Inspection. (a) An assisted living program shall maintain records and reports. (b) The records and reports may be paper or electronic documents. (c) The records and reports shall be open to inspection by the Department or its designee. (d) Except for the records permitted to be stored off-site, an assisted living program shall immediately, upon request, provide copies of records and reports, including medical records of residents, to the Department or its designee. (2) Maintenance. (a) The assisted living program shall maintain files on-site pertaining to: (i) Current residents; (ii) Residents who have been discharged within the last 6 months; (iii) Staff; and (iv) Quality assurance activities. (b) The files listed in §B(2)(a) of this regulation shall be maintained on-site at the licensed assisted living program where residents receive assisted living services. (c) All other records may be stored off-site but shall be available for inspection within 24 hours of a request from the Department or the Department’s designee. C. Posting of Documents. An assisted living program shall post the following documents in a conspicuous place that is visible to residents, potential residents, and other interested parties: (1) All of the following: (a) The notice of compliance or the statement of deficiencies and the plan of correction for the most recent annual licensure survey; and (b) The notice of compliance or the statement of deficiencies and the plan of correction for all surveys conducted since the last annual licensure survey; or (2) A notice describing where in the facility the items listed in §C(1) of this regulation may be found. D. Notice of Deficiencies. (1) If a survey identifies noncompliance with a requirement, the Secretary shall issue a notice: (a) Citing each deficiency; (b) Requiring the assisted living program to submit an acceptable plan of correction within 10 calendar days of receipt of the statement of deficiencies; (c) Notifying the assisted living program of sanctions or that failure to correct the violation may result in sanctions; and (d) Offering the assisted living program the opportunity for informal dispute resolution (IDR). (2) The plan of correction referred to in §D(1)(b) of this regulation shall include: (a) How the assisted living program will correct each deficiency; (b) The date by which each deficient practice will be corrected; (c) How the assisted living program will prevent the deficient practice from recurring; and (d) Who will be responsible for ensuring the deficiency will not reoccur. (3) Failure to return an acceptable plan of correction within the allotted time frame may result in a sanction. (4) A request for an IDR does not change the assisted living program’s requirement to submit a plan of correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency. E. Informal Dispute Resolution (IDR). (1) An assisted living program may request an IDR to dispute one or more deficiencies in a statement of deficiencies. (2) The assisted living program shall submit the request for an IDR to the Department within 10 calendar days of receiving the statement of deficiencies. (3) The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by all evidence for the Department’s consideration. (4) At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing. (5) IDRs are informal in nature and are not attended by legal counsel representing the assisted living program or the Department. (6) The IDR process may not delay the effective date of any enforcement action. (7) In the event an assisted living program requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process. (8) There is no appeal of the Department’s decision in an IDR. #### Regulation .12 Compliance Monitoring. *COMAR 10.07.14.12* A. The Department shall be responsible for monitoring and inspecting assisted living programs to determine compliance with the requirements of this chapter. B. Consistent with an interagency agreement, the Department may delegate certain aspects of its monitoring, inspection, or waiver responsibilities to the Department of Aging or a local health department. C. The Department or its designee may conduct announced or unannounced surveys. D. An assisted living program shall be surveyed on-site, at least annually. The Department may extend the time between surveys to up to 18 months if the assisted living program has: (1) No outstanding plan of correction; (2) No complaints or facility-reported incidents pending investigation; (3) No settlement agreement in effect; (4) No outstanding civil money penalty; and (5) No sanctions in effect. E. The Department, or those agencies delegated responsibility under this regulation, may inspect an assisted living program more frequently than annually if it is considered necessary to determine compliance with this chapter. #### Regulation .13 Administration. *COMAR 10.07.14.13* A. Quality Assurance. (1) The assisted living program manager or their designee shall develop and implement a quality assurance plan. (2) Quality Assurance Plan. (a) The quality assurance plan shall include an annual facility risk assessment for tuberculosis, in accordance with the CDC Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005. (b) The assisted living manager and the delegating nurse shall meet at least every 6 months to review the: (i) Change in status of the assisted living program’s residents; (ii) Service plan requirements; and (iii) Written recommendations, findings, and outcomes of pharmacy reviews, as required by Regulation .31I of this chapter. (c) The assisted living manager shall document the proceedings of the meeting referred to in §A(2)(b) of this regulation. B. Family Council. (1) If assisted living program residents have a family council, the assisted living program shall make reasonable attempts to support and cooperate with the family council. (2) The family council for an assisted living program may include the following members: (a) Members of a current resident’s family; (b) An individual appointed by a current resident who has the capacity to appoint an individual; (c) A resident representative; or (d) An individual appointed by a resident representative. (3) The assisted living program shall provide the family council the right to privacy for meetings and, if possible, the space to meet privately. (4) Staff members may attend a meeting only if requested by the family council. (5) The assisted living program shall consider the family council’s recommendations and grievances and attempt to accommodate those recommendations and grievances that affect residents’ quality of life. (6) The assisted living program shall respond in writing within 30 calendar days to the family council when it has received written requests or grievances from the council. C. Resident Council. (1) If an assisted living program has a resident council, the assisted living program shall make reasonable attempts to support and cooperate with the resident council. (2) A resident council includes current residents of the assisted living program. (3) The assisted living program shall provide the resident council the right to privacy for meetings and, if possible, the space to meet privately. (4) Staff members may attend a meeting only if requested by the resident council. (5) The assisted living program shall consider the council’s recommendations and grievances and attempt to accommodate those recommendations and grievances that affect the residents’ quality of life. (6) The assisted living program shall respond in writing within 30 calendar days to the resident council when it has received written requests or grievances from the council. #### Regulation .14 Staffing Plan. *COMAR 10.07.14.14* A. Following an analysis of the number of residents that the assisted living program intends to serve and the individual needs of each resident, the assisted living program shall develop a staffing plan that identifies the type and number of staff needed to provide the services required by this chapter. B. The assisted living program shall employ or contract with sufficient numbers of staff to comply with the: (1) Requirements of this chapter; (2) Standards of care for the specific conditions of the residents the assisted living program serves; and (3) All other applicable laws and regulations. C. Resident Care Needs. (1) The resident’s care needs shall determine the: (a) Need, amount, and frequency of nursing overview by the registered nurse; (b) Need for on-site nursing services; and (c) Need for awake overnight staff. (2) The Department may approve a waiver of the requirement for awake overnight staff when the assisted living program has demonstrated to the Department its use of an effective electronic monitoring system. (3) The Department may not approve a waiver for awake overnight staff on an Alzheimer’s Special Care Unit. (4) The assisted living program shall comply with applicable requirements of COMAR 10.27.09. D. On-Site Staff. (1) The staffing plan shall include on-site staff sufficient in number and qualifications to meet the 24-hour scheduled and unscheduled needs of the residents. (2) When a resident is in the facility, a staff member shall be present. (3) When a resident is expected to return to the assisted living program, a staff member shall be present. (4) A staffing schedule shall: (a) Be maintained on-site; (b) Include the date, shift hours, and identifying name of all staff members scheduled to work; and (c) Be kept on file for 18 months. E. Awake Overnight Staff. (1) An assisted living program shall provide awake overnight staff when a resident’s assessment using the Resident Assessment Tool indicates that awake overnight staff is required according to instructions on that tool. (2) If a health care practitioner or assessing registered nurse, in the health care practitioner’s or registered nurse’s clinical judgment, does not believe that a resident requires awake overnight staff, the health care practitioner or assessing registered nurse shall document the reasons in the area provided in the Resident Assessment Tool. (3) The assisted living program shall retain this documentation in the resident’s record. (4) Awake overnight staff are required on an approved Alzheimer’s Special Care Unit. F. Electronic Monitoring Systems. (1) Upon the written recommendation of the resident’s health care practitioner, the assisted living program may apply to the Department for a waiver in accordance with Regulation .09 of this chapter to use an electronic monitoring system instead of awake overnight staff. (2) If an electronic monitoring system is approved by the Department for the assisted living program to use, the licensee shall document the approval of the electronic monitoring system in the area provided on the Resident Assessment Tool. (3) When a resident is assessed or reassessed using the Resident Assessment Tool, the health care practitioner shall review and document the: (a) Need for awake overnight staff if the resident’s previous assessment or review of an assessment indicated awake overnight staff was not necessary at the time; and (b) Continued appropriateness of a waiver to use an approved electronic monitoring system instead of awake overnight staff. (4) The assisted living program shall comply with applicable requirements of COMAR 10.27.09. (5) The Department may not approve a waiver for awake overnight staff on an Alzheimer’s Special Care Unit. G. On-Site Nursing Requirements. (1) An assisted living program shall provide on-site nursing when a delegating nurse or health care practitioner, based upon the needs of a resident, issues a nursing or clinical order for that service. (2) If an assisted living manager determines that a nursing or clinical order should not or cannot be implemented, the assisted living manager, delegating nurse, and resident’s health care practitioner shall discuss any alternatives that could safely address the resident’s needs. (3) The assisted living manager shall document in the resident’s record this discussion and all individuals who participated in the discussion. (4) If there are alternatives that could safely address the resident’s needs, the assisted living manager shall notify the resident and, if appropriate, the resident’s legal representative, the delegating nurse, and resident’s health care practitioner of the change to the order. (5) The assisted living manager shall document in the resident’s record this change and the date of notification. (6) If an assisted living manager fails to implement a nursing or clinical order without identifying and providing alternatives to the care or service order, the delegating nurse shall notify the resident’s health care practitioner, the OHCQ, and the resident or, if appropriate, the legal representative of the resident. (7) Failure to implement a nursing or clinical order, without demonstrating why the order should not be followed or without identifying alternatives to care, may result in sanctions against the assisted living program and referral of a licensed or certified staff to the appropriate health occupations licensing board. H. On-site nursing personnel shall work in partnership with the delegating nurse and assisted living program staff to ensure: (1) Adequate assessment of residents; (2) Planning of medical services; and (3) Oversight of nursing activities. #### Regulation .15 Assisted Living Manager. *COMAR 10.07.14.15* A. Qualifications. (1) An individual shall be licensed as required by Health Occupations Article, §9-3A-01, Annotated Code of Maryland, before the individual may practice as an assisted living manager in Maryland. (2) The assisted living manager shall at a minimum: (a) Be 21 years old or older; (b) Possess a high school diploma, a high school equivalency diploma, or other appropriate education and have experience to conduct the responsibilities specified in §C of this regulation; (c) For level 3 licensed programs, have: (i) A 4-year, college-level degree; or (ii) 2 years experience in a health care related field and 1 year of experience as an assisted living program manager or alternate assisted living manager; or (iii) 2 years experience in a health care related field and successful completion of an 80-hour assisted living manager training course approved by the Department; (d) Be free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities; (e) Be immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination; (f) Have no criminal convictions or other criminal history that indicates behavior that is potentially harmful to residents, documented through either a criminal history records check or a background check, completed within 1 month before employment; (g) Have sufficient skills, training, and experience to serve the residents in a manner that is consistent with the philosophy of assisted living; (h) Have verifiable knowledge in: (i) The health and psychosocial needs of the population being served; (ii) The resident assessment process; (iii) Use of service plans; (iv) Cuing, coaching, and monitoring residents who self-administer medications, with or without assistance; (v) Providing assistance with ambulation, personal hygiene, dressing, toileting, and feeding; and (vi) Resident rights; (i) Receive initial and annual training in: (i) Fire and life safety; (ii) Infection control, including standard precautions; (iii) Emergency disaster plans; and (iv) Basic food safety; and (j) Receive initial certification and recertification every 2 years for: (i) Basic first aid taught by a first aid instructor certified by a national organization; and (ii) Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization. (3) An assisted living manager who has completed the training and passed the examination set forth in Regulation .16 of this chapter shall be presumed to have met the knowledge requirements of §A(1)(g) and (h) of this regulation. B. The Department may determine that an individual is not sufficiently qualified to serve as an assisted living manager if that individual’s managerial or administrative experience, or education, is not sufficient to perform the responsibilities set forth in §C of this regulation for the residents the assisted living program intends to serve. C. Duties. The assisted living manager shall: (1) Be on-site or available on call; and (2) Have overall responsibility for: (a) The management of the assisted living program, including recruiting, hiring, training, and supervising all staff, and ensuring that either a criminal history records check or a background check is conducted consistent with the requirements of Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland; (b) The development and implementation of a staffing plan, which includes an orientation and ongoing training program for all staff, with specific training in the management, assessment, and programming for the resident with cognitive impairment as required by Health-General Article, §19-319.1, Annotated Code of Maryland; (c) The development and implementation of all policies, programs, and services as required by this chapter; (d) Requiring all employees to perform hand hygiene with either soap and water or an alcohol-based hand sanitizer before and after each direct resident contact for which hand hygiene is indicated by acceptable practice; (e) Providing or ensuring, through the coordination of community services, that each resident has access to appropriate medical and psychosocial services, as established in the resident service plan developed under Regulation .28 of this chapter; (f) Ensuring that there is appropriate coordination of all components of a resident’s service plan, including necessary transportation and delivery of needed supplies; (g) Ensuring that there is appropriate oversight and monitoring of the implementation of each resident’s service plan; (h) Ensuring that all record keeping conforms to the requirements of this chapter and other applicable laws; (i) Ensuring that all requirements of this chapter and other applicable laws are met; (j) Implementing a nursing or clinical order of the delegating nurse or documenting in the resident’s record why the order should not be implemented; (k) Notifying the Department: (i) When the manager terminates the program’s contract with or employment of a delegating nurse; and (ii) Of the reason why the contract or employment was terminated; (l) Notifying the resident and, if applicable, the resident representative or interested family member of any: (i) Significant change in condition of the resident; (ii) Adverse event that may result in a change in condition; (iii) Outcome of the resident’s care that results in an unanticipated consequence; and (iv) Corrective action, if any; (m) Ensuring that the annual influenza vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local influenza activity are elevated; and (n) Ensuring that the COVID-19 vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local COVID-19 activity are elevated. #### Regulation .16 80-Hour Assisted Living Manager Training Course. *COMAR 10.07.14.16* A. In addition to the requirements in Regulation .15 of this chapter, by January 1, 2006, an assisted living manager shall complete an 80-hour manager training course that is approved by the Department. B. The completed manager’s training course shall: (1) Consist of 80 hours of course work and include an examination; and (2) Provide the training through in-person courses, virtual training methods, or a combination of both. C. An assisted living manager employed in a program shall complete 20 hours of Department-approved continuing education every 2 years. D. A program that fails to employ an assisted manager who meets the requirements of this regulation may be subject to: (1) Sanctions under Regulation .57 of this chapter; and (2) A civil money penalty not to exceed $10,000. E. The training requirements of §A of this regulation do not apply to an individual who: (1) Is employed by a program and has enrolled in a Department-approved manager training course that the individual completes within 6 months; (2) Is temporarily serving as an assisted living manager under Health Occupations Article, §9-3A-01, Annotated Code of Maryland, due to an assisted living manager leaving employment and before the hiring of a permanent manager; (3) Has been employed as an assisted living manager in the State for 1 year before January 1, 2006; or (4) Is licensed as a nursing home administrator in the State. F. The Department may require an individual who is exempt under the provisions of §E of this regulation to complete a manager training course and examination if: (1) The Department finds that the assisted living manager repeatedly has violated State law or regulations on assisted living; and (2) Those violations have caused or have the potential to cause physical or emotional harm to a resident. #### Regulation .17 80-Hour Assisted Living Manager Basic Training Course. *COMAR 10.07.14.17* A. The 80-hour assisted living manager basic training course shall include the following content: (1) Philosophy of assisted living, 2 hours, including: (a) Philosophy and background of assisted living and aging in place; (b) Objectives and principles of assisted living resident programs; (c) Comparison of assisted living to other residential programs; (d) Basic concepts of choice, independence, privacy, individuality, and dignity; and (e) Normalization of the environment; (2) Aging process and its impact, 4 hours, including: (a) Physical characteristics of the assisted living residents; (b) Psychosocial characteristics of the assisted living residents; (c) Basic needs of the elderly and disabled; and (d) Activities of daily living; (3) Assessment and level of care waiver, 6 hours, including: (a) Purpose and process; (b) Guidelines for conducting assessments; (c) Level of care assessments; and (d) Collaboration with the delegating nurse; (4) Service planning, 6 hours, including: (a) Required services; (b) Enhanced scope of services; (c) Development of individualized service plans; (d) Scheduling of appropriate activities; (e) Structure of activities; (f) Care notes; and (g) Collaboration with the delegating nurse; (5) Clinical management, 20 hours, including: (a) Role of the delegating nurse; (b) Appropriate nurse delegation; (c) Concept of self-administration of medications; (d) Concept of medication management; (e) Assistance with self-administration of medications; (f) Administration of medications; (g) Coordination of services and care providers; (h) Collaboration with the delegating nurse; (i) Preventing medication errors; (j) Patient safety; (k) Medication monitoring; (l) Pharmacy consultation; (m) Medication storage; (n) Infection prevention and control to include: (i) Standard and contact precautions; (ii) Bloodborne pathogens; (iii) Standard hand hygiene practices; (iv) Safe injection practices; (v) Use of personal protective equipment; and (vi) Cleaning and disinfection of equipment and the environment; (o) Appropriate staffing patterns; (p) Pressure sores; (q) Effective pain management; (r) Basic first aid taught by a first aid instructor certified by a national organization; (s) Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization; (t) Substance abuse; (u) Trauma-informed care; and (v) A trauma-informed approach to care delivery; (6) Admission and discharge criteria, 4 hours, including: (a) Overview of criteria for admission and discharge; (b) Resident contracts; (c) Resident rights; (d) Financial management of resident’s funds; and (e) Working with families of residents; (7) Nutrition and food safety, 8 hours, including: (a) Menu and meal planning; (b) Basic nutritional needs; (c) Safe food handling; (d) Preventing food-borne illnesses; (e) Therapeutic diets; and (f) Dehydration; (8) Dementia, mental health, and behavior management, 12 hours, including: (a) An overview consisting of: (i) Description of normal aging and conditions causing cognitive impairment; (ii) Description of normal aging and conditions causing mental illness; (iii) Risk factors for cognitive impairment; (iv) Risk factors for mental illness; (v) Health conditions that affect cognitive impairment; (vi) Health conditions that affect mental illness; (vii) Early identification and intervention for cognitive impairment; (viii) Early identification and intervention for mental illness; and (ix) Procedures for reporting cognitive, behavioral, and mood changes; (b) Effective communication consisting of: (i) Effect of cognitive impairment on expressive and receptive communication; (ii) Effect of mental illness on expressive and receptive communication; (iii) Effective communication techniques, including verbal, nonverbal, tone and volume of voice, and word choice; and (iv) Environmental stimuli and influences on communication, including setting, noise, and visual cues; (c) Behavioral intervention consisting of: (i) Identifying and interpreting behavioral symptoms; (ii) Problem solving for appropriate intervention; (iii) Risk factors and safety precautions to protect other residents and the individual; (iv) De-escalation techniques; and (v) Collaboration with the delegating nurse; (d) Making activities meaningful consisting of: (i) Understanding the therapeutic role of activities; (ii) Creating opportunities for activities, including productive, leisure, and self-care; and (iii) Structuring the day; (e) Staff and family interaction consisting of: (i) Building a partnership for goal-directed care; (ii) Understanding family needs; and (iii) Effective communication between family and staff; and (f) Managing staff stress consisting of: (i) Understanding the impact of stress on job performance, staff relations, and overall facility environment; (ii) Identification of stress triggers; (iii) Self-care skills; (iv) De-escalating techniques; and (v) Devising support systems and action plans; (9) End of life care, 4 hours, including: (a) Advance directives; (b) Hospice care; (c) Maryland Medical Orders for Life-Sustaining Treatment (MOLST) order form; (d) Power of attorney; (e) Appointment of a health care agent; (f) Living will; (g) Pain management; (h) Providing comfort and dignity; and (i) Supporting the family; (10) Management and operation, 4 hours, including: (a) Role of the assisted living manager; (b) Overview of accounting, accounts payable, and accounts receivable; (c) The revenue cycle and budgeting; (d) The basics of financial statements; (e) Hiring and training of staff; (f) Developing personnel policies and procedures; (g) Census development; and (h) Marketing; (11) Emergency planning, 4 hours, including: (a) Fire, disaster, and emergency preparedness; (b) Occupational Safety and Health Administration (OSHA) requirements; (c) Maintaining the building, grounds, and equipment; (d) Elopements; (e) Transfers to the hospital; (f) Evacuations; (g) Power outages; (h) Severe weather; (i) Fire; (j) Emergency response systems; and (k) Security systems; (12) Quality assurance, 4 hours, including: (a) Incident report processes; and (b) Quality improvement processes; and (13) Survey process, 2 hours, including: (a) State statutes and regulations; (b) What to expect during a survey; and (c) Documentation. B. A person seeking to offer the assisted living manager training course shall request and obtain approval by the Department by: (1) Submitting the proposed curriculum and training materials to the Department; and (2) Being available for an in-person or telephone interview by the Department. #### Regulation .18 Alternate Assisted Living Manager. *COMAR 10.07.14.18* An alternate assisted living manager shall: A. Be available to assume the responsibilities described in Regulation .15C(2)(a)—(l) of this chapter when the assisted living manager is not available; B. Be 21 years old or older; C. Have 2 years of experience in a health-related field; and D. Meet the qualifications of Regulation .19B(1)—(7) of this chapter. #### Regulation .19 Other Staff — Qualifications. *COMAR 10.07.14.19* A. Age Requirements of Other Staff. (1) Direct resident care staff shall be: (a) 18 years old or older; (b) 16 or 17 years old who are enrolled in a certified nursing assistant training program and are supervised until certified; or (c) 16 or 17 years old and are certified as a nursing assistant. (2) Other staff not performing direct resident care may be younger than 18 years old. B. Qualifications of Other Staff. The qualifications of other staff include: (1) Evidence that the staff is: (a) Free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities; (b) Immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination; and (c) Free from any impairment which would hinder the performance of assigned responsibilities; (2) Having no criminal convictions or criminal history that indicates behavior that is potentially harmful to residents, as evidenced through a background check completed within 30 calendar days before employment; (3) Having sufficient skills, education, training, and experience to serve the residents in a manner that is consistent with the philosophy of assisted living; (4) Participating in and completing an orientation program and ongoing training to ensure that the residents receive services that are consistent with their needs and generally accepted standards of care for the specific conditions of those residents to whom staff will provide services; (5) Receiving initial and annual training in: (a) Fire and life safety, including the use of fire extinguishers; (b) Infection control, including standard precautions, contact precautions, and hand hygiene; (c) Basic food safety; and (d) Emergency disaster plans; (6) Completing basic first aid training taught by a first aid instructor certified by a national organization and recertification every 2 years; (a) Licensed practical nurses and registered nurses are exempted from basic first aid training and retraining. (7) Having training or experience in: (a) The health and psychosocial needs of the population being served as appropriate to their job responsibilities; (b) The resident assessment process; (c) The use of service plans; and (d) Resident’s rights; and (8) Holding appropriate licensure or certification as required by law. C. With the exception of certified nursing assistants (CNAs) and geriatric nursing assistants (GNAs), if job duties involve the provision of personal care services as described in Regulation .30E of this chapter, an employee: (1) Shall demonstrate competence to the delegating nurse before performing these services; and (2) May work for 10 calendar days before demonstrating to the delegating nurse that they have the competency to provide these services, if the employee performing the tasks is accompanied by: (a) A certified nursing assistant; (b) A geriatric nursing assistant; or (c) An individual who has been approved by the delegating nurse. D. Basic cardiopulmonary resuscitation (CPR) training, including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization shall be provided on an initial and ongoing basis to a sufficient number of staff to ensure that a trained staff member is available to perform CPR in a timely manner, 24 hours a day. E. Relief personnel shall be available at all times in the event that the regularly scheduled staff members are unavailable. Relief personnel shall meet the requirements of §B of this regulation. F. Proof of training shall include: (1) Date of class; (2) Course content; (3) Documentation of successful completion of the training content; (4) Written, electronic, or video proof of attendee participation; and (5) Signature, qualifications, and contact information of each trainer. G. Training with No Direct Interaction. When the training method does not involve direct interaction between faculty and participant, the assisted living program shall make available to the participant a trained individual to answer questions and respond to issues during the training. H. Training in Cognitive Impairment, Mental Illness, and Behavioral Health. (1) When job duties involve the provision of personal care services as described in Regulation .30E of this chapter, employees shall receive a minimum of 6 hours of initial training on cognitive impairment, mental illness, and behavioral health within the first 120 calendar days of employment. (2) The training shall be designed to meet the specific needs of the assisted living program’s population as determined by the assisted living manager, including the following, as appropriate: (a) An overview of the following: (i) A description of normal aging and conditions causing cognitive impairment; (ii) A description of normal aging and conditions causing mental illness; (iii) Risk factors for cognitive impairment; (iv) Risk factors for mental illness; (v) Health conditions that affect cognitive impairment; (vi) Health conditions that affect mental illness; (vii) Early identification of and intervention for cognitive impairment; (viii) Early identification of and intervention for mental illness; and (ix) Procedures for reporting cognitive, behavioral, and mood changes; (b) Effective communication, including: (i) The effect of cognitive impairment on expressive and receptive communication; (ii) The effect of mental illness on expressive and receptive communication; (iii) Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and (iv) Environmental stimuli and influences on communication; (c) Behavioral intervention, including: (i) Identifying and interpreting behavioral symptoms; (ii) Problem solving for appropriate intervention; (iii) Risk factors and safety precautions to protect the individual and other residents; and (iv) De-escalation techniques; (d) Making activities meaningful, including: (i) Understanding the therapeutic role of activities; (ii) Creating opportunities for productive, leisure, and self-care activities; and (iii) Structuring the day; (e) Staff and family interaction, including: (i) Building a partnership for goal-directed care; (ii) Understanding the needs of families; and (iii) Effective communication between family and staff; (f) End of life care, including: (i) Pain management; (ii) Providing comfort and dignity; and (iii) Supporting the family; and (g) Managing staff stress, including: (i) Understanding the impact of stress on job performance, staff relations, and overall facility environment; (ii) Identification of stress triggers; (iii) Self-care skills; (iv) De-escalation techniques; and (v) Devising support systems and action plans. (3) When job duties do not involve the provision of personal care services as described in Regulation .30E of this chapter, employees shall receive a minimum of 2 hours of training on cognitive impairment, mental illness, and behavioral health within the first 120 calendar days of employment. The training shall include: (a) An overview of the following: (i) A description of normal aging and conditions causing cognitive impairment; (ii) A description of normal aging and conditions causing mental illness; (iii) Risk factors for cognitive impairment; (iv) Risk factors for mental illness; (v) Health conditions that affect cognitive impairment; (vi) Health conditions that affect mental illness; (vii) Early identification and intervention for cognitive impairment; (viii) Early identification and intervention for mental illness; and (ix) Procedures for reporting cognitive, behavioral, and mood changes; (b) Effective communication, including: (i) The effect of cognitive impairment on expressive and receptive communication; (ii) The effect of mental illness on expressive and receptive communication; (iii) Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and (iv) Environmental stimuli and influences on communication; and (c) Behavioral intervention including risk factors and safety precautions to protect the individual and other residents. (4) Ongoing training in cognitive impairment and mental illness shall be provided annually consisting of, at a minimum: (a) 2 hours for employees whose job duties involve the provision of personal care services as described in Regulation .30E of this chapter; and (b) 1 hour for employees whose job duties do not involve the provision of personal care services as described in Regulation .30E of this chapter. I. Training may be provided through various means, including: (1) Classroom instruction; (2) In-service training; (3) Internet courses; (4) Correspondence courses; (5) Prerecorded training; or (6) Other training methods approved by the Department. J. When the training method does not involve direct interaction between faculty and participant, the assisted living program shall make available to the participant during the training a trained individual to answer questions and respond to issues raised by the training. #### Regulation .20 Personnel Records. *COMAR 10.07.14.20* The assisted living program shall maintain the following information for each staff member: A. Full name, age, and gender; B. Address and telephone number; C. Educational background; D. Employment history; E. Notes on references; F. Performance evaluations; G. Attendance records; H. Individual to be notified in case of emergency; I. Documentation that a criminal history records check was conducted in accordance with Health-General Article, §19-1901, Annotated Code of Maryland; J. Documentation that the staff is: (1) Free from tuberculosis in a communicable form in accordance with Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities; and (2) Immune to measles, mumps, rubella, and varicella as evidenced by history of disease or vaccination; K. Evidence that the annual influenza vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local influenza activity are elevated; L. Evidence that the COVID-19 vaccine has been advised in accordance with current CDC recommendations and documented surveillance of non-immune staff when indicators of local COVID-19 activity are elevated; M. Documentation of appropriate licensure or certification as required by law; N. Documentation of all required training and courses; and O. Documentation that a check of the federal Department of Health and Human Services, Office of the Inspector General’s List of Excluded Individuals/Entities database was conducted prior to hiring. #### Regulation .21 Delegating Nurse. *COMAR 10.07.14.21* A. The assisted living program shall have a current and signed agreement with a registered nurse for services of a delegating nurse and delegation of nursing tasks. If the delegating nurse is an employee of the assisted living program, the employee’s job description may satisfy this requirement. B. The program shall maintain documentation that the delegating nurse has completed the mandatory training course developed by the Board of Nursing. C. Duties. The delegating nurse shall: (1) Be on-site to observe each resident at least every 45 calendar days; (2) Be available on call at all times as required under this chapter or have a qualified alternate delegating nurse available on call; and (3) Have the overall responsibility for: (a) Managing the clinical oversight of resident care in the assisted living program; (b) Issuing nursing or clinical orders, based upon the needs of residents; (c) Reviewing the assisted living manager’s assessment of residents; (d) Appropriate delegation of nursing tasks; and (e) Notifying the Department: (i) If the delegating nurse’s contract or employment with the assisted living program is terminated; and (ii) Of the reason why the contract or employment was terminated. D. If the delegating nurse is not available to perform any duties, there shall be a qualified alternate delegating nurse available to perform those duties. E. When an assisted living manager fails to implement nursing or clinical orders without identifying alternatives to the care or service order, the delegating nurse shall notify the resident’s health care practitioner, the Department, and the resident, or, if applicable, the resident representative. #### Regulation .22 Preadmission Requirements. *COMAR 10.07.14.22* A. Before Move In. (1) Before admission the assisted living manager or designee in collaboration with the delegating nurse shall determine whether: (a) The resident may be admitted under the assisted living program’s licensure category; (b) Requires a level of care that the Department has approved for the assisted living program; and (c) The resident’s needs can be met by the program. (2) Within 30 days before admission, the assisted living manager or designee shall determine admission eligibilities described in §A(1) of this regulation based on completion of a resident assessment using the Resident Assessment Tool as described in §B of this regulation. The Department may modify the level of care determination made by the assisted living program at any time. The Resident Assessment Tool: (a) Determines the resident’s required level of care; (b) Forms the basis for development of the resident’s service plan; and (c) Determines whether the resident needs awake overnight monitoring. B. Resident Assessment Tool. (1) Within 30 days prior to admission, the prospective resident’s health status shall be documented on the Resident Assessment Tool. (2) Information on the Resident Assessment Tool shall be based on an examination conducted by a primary physician, certified nurse practitioner, certified registered nurse midwife, registered nurse, or physician assistant that is based on the resident’s current health status. (3) If the potential resident is admitted on an emergency basis by a local department of social services, the required assessment using the Resident Assessment Tool shall be completed as soon as possible but no later than 14 calendar days after the emergency admission. (4) Information on the assessment shall include at a minimum: (a) Recent medical history, including any acute medical conditions or hospitalizations; (b) Significant medical conditions affecting functioning, including the individual’s ability for self-care, cognition, physical condition, and behavioral and psychosocial status; (c) Other active and significant chronic or acute medical diagnoses; (d) Known allergies to foods and medications; (e) Medical confirmation that the individual is free from communicable tuberculosis, and other active reportable airborne communicable diseases; (f) Current scheduled and as needed (PRN) medications; (g) Current and other needed treatments and services for medical conditions and related problems; (h) Current nutritional status, risk factors for malnutrition and dehydration, and, if available, height and weight; (i) Diets ordered by a health care practitioner; (j) Medically necessary limitations or precautions; and (k) Monitoring or tests that need to be performed or followed up after admission. C. Reassessment Documented on the Resident Assessment Tool. (1) The Resident Assessment Tool shall be reviewed at least every 6 months and the review shall be documented by the delegating nurse and assisted living manager. (2) A new Resident Assessment Tool shall be completed: (a) At least annually; (b) Within 48 hours, but not later than required by the resident’s condition, after a significant change in a resident’s condition; and (c) Within 48 hours of a delegating nurse’s determination that a new Resident Assessment Tool needs to be completed. (3) If the previous Resident Assessment Tool did not indicate the need for awake overnight staff, each reassessment or review of the assessment shall include documentation as to whether awake overnight staff is required due to a change in the resident’s condition. D. Functional Assessment. Within 30 calendar days before admission, the assisted living manager, or designee, shall collect on the Resident Assessment Tool the following information regarding the current condition of each resident: (1) Level of functioning in activities of daily living; (2) Level of support and intervention needed, including any special equipment and supplies required to compensate for the individual’s deficits in activities of daily living; (3) Current physical or psychological symptoms requiring monitoring, support, or other intervention by the assisted living program; (4) Capacity for making personal and health care related decisions; (5) Presence of disruptive behaviors, or behaviors which present a risk to the health and safety of the resident or others; and (6) Social factors, including: (a) Significant problems with family circumstances and personal relationships; (b) Spiritual status and needs; and (c) Ability to participate in structured and group activities, and the resident’s current involvement in these activities. E. Resident Requirements for Awake Overnight Staff. (1) Before admission, the assisted living manager shall ensure that the resident is assessed using the Resident Assessment Tool. (2) When the resident scores in any of the areas identified as “Triggers for Awake Overnight Staff” in the Resident Assessment Tool, the assisted living program shall provide awake overnight staff or document why awake overnight staff is not necessary in accordance with Regulation .14E of this chapter. F. Short-Term Residential Care Requirements. (1) For persons admitted for short-term residential care, the following are required: (a) Current physical condition and medical status as specified in §B(4) of this regulation; (b) Functional assessment as specified in §D of this regulation; and (c) A resident agreement, in accordance with Regulations .26 and .27 of this chapter. (2) If the person is admitted for a subsequent short-term admission, the following are required: (a) Current physical condition and medical status as specified in §B(4) of this regulation; (b) Functional assessment as specified in §D of this regulation; and (c) A new resident agreement or an addendum to the prior resident agreement. G. A resident admitted as an emergency placement by a local department of social services is exempt from all physical examination and assessment requirements of this regulation if the resident is in temporary emergency shelter and services status, not to exceed 14 calendar days, with notification to the Department of the placement within 48 hours. #### Regulation .23 Admission Requirements. *COMAR 10.07.14.23* A. Discrimination Prohibited. An assisted living program licensed under this chapter may not discriminate in admitting or providing care to an individual because of the individual’s: (1) Race; (2) Color; (3) National origin; (4) Sexual orientation; (5) Gender identity; (6) Religion; (7) Physical disability; or (8) Mental disability. B. An assisted living program may not provide services to individuals who at the time of initial admission, as established by the initial assessment, would require: (1) More than intermittent nursing care; (2) Treatment of stage three or stage four skin ulcers; (3) Ventilator services; (4) Skilled monitoring, testing, and frequent adjustment of medications and treatments where there is the presence of a fluctuating acute condition; or (5) Monitoring of a chronic medical condition that is not controllable through readily available medications and treatments. C. An individual may not be admitted to an assisted living program who is: (1) Dangerous to the individual or others when the assisted living program would be unable to eliminate the danger through the use of appropriate treatment modalities; or (2) At high risk for health or safety complications which cannot be adequately managed. D. The provisions of §§B and C of this regulation do not apply to a resident being admitted to an assisted living program when the resident is under the care of a general hospice care program licensed by the Department which ensures delivery of one or more of the services described under §§B and C of this regulation through the hospice program’s plan of care. #### Regulation .24 Resident-Specific Level of Care Waiver. *COMAR 10.07.14.24* A. An assisted living program may request a resident-specific waiver to continue to provide services to a resident if: (1) The resident’s level of care exceeds the level of care for which the assisted living program has authority to provide; or (2) The resident would require care that falls into one of the categories set forth in Regulation .23. B. An assisted living program may not continue providing services to a resident whose needs exceed the level of care for which the licensee has authority to provide, without approval of the Department. C. Temporary Change in Level of Care. (1) A level of care waiver is not required for a resident whose level of care is expected to increase for a period not to exceed 30 calendar days. (2) The assisted living program shall submit a waiver application as soon as program personnel determine that the increased level of care or the condition requiring the waiver is likely to exceed 30 calendar days. D. When requesting a resident-specific waiver, the assisted living program shall demonstrate that: (1) The assisted living program has the capability of meeting the needs of the resident; and (2) The needs of other residents will not be jeopardized. E. Approval of Waiver Request. (1) The Department may grant a resident-specific level of care waiver, with or without conditions, if the Department determines that the: (a) Resident’s needs can be met; (b) Needs of other residents will not be jeopardized; and (c) Provider complies with the requirements of Regulation .47A of this chapter. (2) Terms of a Resident-Specific Waiver. (a) An approved resident-specific waiver applies only to the resident for whom the waiver was granted. (b) The waiver no longer applies if the resident’s level of care, as determined through an assessment, declines or improves to the point that the resident requires a higher or lower level of care than authorized by the waiver. (c) When the Department grants a waiver to continue to provide services to a resident whose needs fall within one of the categories in Regulation .23, the assisted living program shall, at a minimum, comply with certain federal Medicare requirements for home health agencies referenced in 42 CFR §§484.1, 484.2, 484.40—484.80, 484.100—484.115, 484.200—484.265, and 484.300—484.375. F. Denial of a Resident-Specific Waiver Request. (1) The Department shall deny the request for a resident-specific waiver if the Department determines that the: (a) Assisted living program is not capable of meeting the needs of the resident; or (b) Needs of other residents will be jeopardized if the waiver request is granted. (2) The Department may not grant resident-specific waivers: (a) That total more than 50 percent of the assisted living program’s bed capacity for residents whose needs exceed the level of care for which the assisted living program has authority to provide as specified in Regulation .04D of this chapter; or (b) For the continuation of services to a resident whose needs fall within one of the categories set forth in .23B of this regulation, for up to 20 percent of capacity, or 20 beds, whichever is less, unless a waiver is granted by the Department. (3) The decision of the Department may not be appealed. (4) The Department’s denial of a resident-specific level of care waiver request: (a) Does not prohibit the resident from being admitted to another program that is capable of meeting the resident’s needs and is licensed to provide that level of care; and (b) Does not provide any exception to the admission restrictions set forth in .23A of this regulation. (5) If the Department initially denies a resident-specific level of care waiver request and determines that a resident’s health or safety may significantly deteriorate because of the provider’s inability to provide or ensure access to care that will meet the needs of the resident, the: (a) Denial is not subject to informal dispute resolution; and (b) Department may direct the relocation of the resident to a safe environment. G. The Department’s Decision. (1) The Department shall communicate the decision to grant or deny a resident-specific waiver to the assisted living manager in writing, including all appropriate supporting documentation, within 7 calendar days from receipt of the waiver request. (2) Dispute of a Resident-Specific Waiver. (a) If the resident or the resident representative disagrees with the Department’s denial of a waiver request, the resident or, as applicable, the resident representative may dispute the Department’s decision by: (i) Submitting a written request to the Department within 7 calendar days after receipt of the Department’s denial; and (ii) Including in the written request the reasons why the Department’s denial may be incorrect. (b) The Department shall consider the request and notify the resident or the resident representative within 7 calendar days of receipt of the request whether or not the Department’s decision to deny a level of care waiver is sustained. (c) The Department’s decision from the dispute is not: (i) A contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland; or (ii) Subject to further appeal. (d) In making a decision to sustain or change the decision to deny a waiver request, the Department shall consider, among other factors, whether the: (i) Granting of waivers has resulted in one or more residents having experienced a decline in their physical, functional, or psychosocial well-being; and (ii) Decline in the residents’ condition might have been prevented had the waivers not been granted. (e) If the Department sustains the decision to deny the waiver request, the Department shall notify the assisted living program of what action is required, including, but not limited to: (i) Revocation of some or all of the resident-specific waivers which have been granted; or (ii) A change in licensure category. (f) Decision to Sustain the Denial of Waiver Request. (i) Upon notification of the decision to sustain the denial of waiver, the assisted living program shall submit a response with an appropriate plan of action for approval by the Department. (ii) If the Department does not approve the assisted living program’s plan of action, the Department shall notify the assisted living program that one or more resident-specific waivers are revoked or that a change in licensure status is required. (iii) The determination to sustain the denial of waiver request may not be appealed. (iv) Failure of the assisted living program to comply with the Department’s decision is grounds for the imposition of sanctions. H. The Department shall, during a survey or other inspection, or when a resident-specific level of care waiver request is made, review the number of resident-specific waivers an assisted living program holds to ensure that the assisted living program continues to be able to provide appropriate care to all of its residents and to ensure that the current licensure category is appropriate. The Department shall notify the assisted living program if, at any time, the Department determines that: (1) The assisted living program is not providing appropriate care to its residents because of the number of resident-specific waivers it holds; or (2) The number of resident-specific waivers an assisted living program holds necessitates a change in licensure category. #### Regulation .25 Payment of Funds Before Admission. *COMAR 10.07.14.25* If an assisted living program requires payment of funds before admission, the funds shall be fully refundable unless the assisted living program discloses, in writing, what portion is not refundable. #### Regulation .26 Resident Agreement — General Requirements and Nonfinancial Content. *COMAR 10.07.14.26* A. Except as otherwise provided under §E of this regulation, for a person admitted for other than short-term residential care, the resident or the resident agent and the assisted living manager or their designee shall sign, before or at the time of admission, a resident agreement that: (1) Is a clear and complete reflection of commitments agreed to by the parties, and the actual practices that will occur in the assisted living program; (2) Is accurate, precise, easily understood, legible, readable, and written in plain English; (3) Conforms to all relevant State and local laws and requirements in effect when the agreement is executed; and (4) Recommends review of the agreement by an attorney or other representative chosen by the resident. B. For a person admitted for short-term residential care, the resident or the resident agent and the assisted living manager or their designee shall sign, before or at the time of admission, a resident agreement as set forth in this regulation excluding the provisions of §D(9)(c) and 8(d) and (e) of this regulation. C. The assisted living program shall: (1) Give a copy of the signed resident agreement to the resident and the resident agent; (2) Maintain a copy of the resident agreement on-site; and (3) Make the resident agreement available for review by the Department or its designee. D. The resident agreement shall include, at a minimum, the following provisions: (1) A statement of the level of care for which the assisted living program is licensed; (2) The level of care needed by the resident, as determined by the initial assessment required by Regulation .05 of this chapter; (3) Unless the assisted living program is part of a continuing care retirement community and the agreement is signed by a continuing care subscriber as defined in COMAR 32.02.01.01B, a statement indicating that if a resident’s level of care, after admission, exceeds the level of care for which the assisted living program is permitted to provide and a waiver for the continued stay of the resident has not been granted, the assisted living program shall discharge the resident from the program; (4) If the assisted living program is part of a continuing care retirement community and a separate, concurrent resident agreement is signed by a continuing care subscriber as defined in COMAR 32.02.01.01B, a statement indicating that if the resident’s level of care, after admission to assisted living, exceeds the level of care for which the assisted living program is permitted to provide and a waiver for the continued stay of the resident has not been granted: (a) The assisted living program may not provide any services to the resident beyond that which it is licensed to provide; (b) If the assisted living program offers either comprehensive care services, or priority access to comprehensive care services, and a comprehensive care bed is available for occupancy, the resident shall be given the option to transfer to comprehensive care; and (c) The resident may be discharged from the continuing care retirement community only for just cause as set forth in COMAR 32.02.01.31B; (5) A listing of services provided by the assisted living program and a listing of personal care and health care services the assisted living program does not provide; (6) An explanation of the assisted living program’s complaint or grievance procedure; (7) A policy on resident self-administration of medications; (8) A policy on the administration of medications to a resident by a spouse or domestic partner who is also a resident of the assisted living program; (9) Occupancy provisions, including: (a) Policies regarding bed and room assignment, including the specific room and bed assigned to the resident at the time of admission; (b) Policies for temporary or permanent changes to the resident’s accommodations, including: (i) Relocating the resident within the facility; (ii) Making a change in roommate assignment; or (iii) Increasing or decreasing the number of individuals occupying a room; (c) Procedures for transferring the resident to another facility; (d) The availability of locks for storage; (e) The availability of locks, if any, for the resident’s room; (f) Security procedures which the assisted living program shall implement to protect the resident and the resident’s property; (g) The staff’s right, if any, to enter a resident’s room; (h) The resident’s rights and obligations concerning use of the facility, including common areas; (i) If non-residents live on the premises, the assisted living program shall disclose what parts of the licensed space they are permitted in and during what hours; (j) Provisions for continuous service in the event of an emergency; (k) An acknowledgment that the resident or the resident representative has reviewed all assisted living program rules, requirements, restrictions, or special conditions that the assisted living program will impose on the resident; and (l) The assisted living program’s bed hold policy in case of unavoidable or optional absences such as hospitalizations, recuperative stays in other settings, or vacation, including: (i) The conditions under which the assisted living program will hold a bed; (ii) Relevant time frames; (iii) Payment terms; (iv) The circumstances under which the program will no longer hold the bed; and (v) The period of time during which the resident is permitted to return and resume residence in the facility; (10) Admission and discharge policies and procedures, including: (a) Any additional admission requirement imposed by the assisted living program; (b) Those actions, circumstances, or conditions which may result in the resident’s discharge from the assisted living program; (c) The procedures which the assisted living program shall follow to verify that the receiving program or facility has the required license to operate that type of program or facility; (d) The procedures which the assisted living program shall follow when discharging a resident without the resident’s consent, except in the case of a health emergency or substantial risk to other residents, including: (i) The termination of the resident agreement on discharge; and (ii) At least 30 calendar days written notice to the resident or resident representative before the effective date of the discharge; (e) Procedures that the assisted living program shall follow when discharging, without 30 calendar days notice, a hospitalized resident whose medical needs have advanced beyond the level of care for which the assisted living program is licensed to provide. The procedures shall include at a minimum: (i) A statement that a transfer to the hospital is not grounds for discharge; and (ii) A requirement that the delegating nurse shall perform and document a nursing assessment of the resident’s condition at the hospital to determine if the resident can safely return to the facility; (f) Procedures that the resident shall follow when terminating the resident agreement; (g) A statement that the resident or resident representative shall give at least 30 calendar days notice to the assisted living program before the effective date of termination except in the case of a health emergency; (h) Procedures the assisted living program shall follow when a multiple person unit is vacated by one resident due to discharge or death, including provisions: (i) For termination of the agreement; and (ii) Appropriate refunds; (11) Obligations of the licensee, the resident, or the resident representative as to: (a) Arranging for or overseeing medical care; and (b) The monitoring of the health status of the resident; (12) Adult medical day care policies and availability; and (13) Any arrangements the resident has made, or wishes to make, with regard to burial, including, but not limited to: (a) Financial; (b) Religion preferred funeral director, if any; and (c) The name, address, and relationship of any person who has agreed to claim the body of the resident or who has agreed to assume funeral or burial responsibility. E. If the services provided in an assisted living program that is part of a continuing care retirement community are covered under a continuing care agreement that complies with Human Services Article, Title 10, Subtitle 4, and Health-General Article, §19-1806, Annotated Code of Maryland: (1) The Department may not require a separate resident agreement for the assisted living program; and (2) The requirements set forth in this regulation and Regulation .27 of this chapter do not apply. F. The assisted living program may not include a provision in the agreement which is inconsistent with any of the requirements of this chapter. #### Regulation .27 Resident Agreement — Financial Content. *COMAR 10.07.14.27* A. The resident agreement shall include financial provisions, which include at a minimum: (1) Obligations of the assisted living program and the resident, or the resident agent, as to: (a) Handling the finances of the resident; (b) The purchase or rental of essential or desired equipment and supplies; (c) Arranging and contracting for services not covered by the resident agreement; (d) Ascertaining the cost of and purchasing durable medical equipment; and (e) Disposition of resident property upon discharge or death of the resident; and (2) Rate structure and payment provisions covering: (a) All rates to be charged to the resident, including, but not limited to: (i) Service packages; (ii) Fee for service rates; and (iii) Any other non-service-related charges; (b) Notification of the rate structure applicable for other levels of care provided by the assisted living program and the criteria to be used for imposing additional charges for the provision of additional services, if the resident’s service and care needs change; (c) Payment arrangements and fees, if known, for third-party services not covered by the resident agreement, but arranged for by either the resident, the resident agent, or the assisted living program; (d) Identification of the persons responsible for payment of all fees and charges and a clear indication of whether the person’s responsibility is or is not limited to the extent of the resident’s funds; (e) A provision which provides at least 45 calendar days notice of any rate increase, except if necessitated by a change in the resident’s medical condition; (f) Fair and reasonable billing, payment, and credit policies; (g) The procedures the assisted living program will follow in the event the resident or resident agent can no longer pay for services provided for in the resident agreement or for services or care needed by the resident, including 30 calendar days notice of the resident’s discharge to the: (i) Ombudsman within the Department of Aging or local area agency on aging; and (ii) Local Department of Human Services or Adult Protective Services; and (h) Terms governing the refund of any prepaid fees or charges, in the event of a resident’s discharge from the assisted living program or termination of the resident agreement. B. When the resident’s needs significantly change and the level of service provided needs to be increased or decreased, the resident agreement shall be amended by the parties to reflect the changes in services being provided and any applicable increase or decrease in charges. C. Charges that incur after the death of the resident may not include services provided to the resident after their death, but may include administrative charges. #### Regulation .28 Service Plan. *COMAR 10.07.14.28* A. Service Plan Development. (1) The assisted living manager, or designee, shall ensure that all services are provided in a manner that respects and enhances the dignity, privacy, and independence of each resident. (2) A service plan for each resident shall be developed in a manner that enhances the principles of dignity, privacy, resident choice, resident capabilities, individuality, and independence without compromising the health or reasonable safety of other residents. (3) The resident shall be invited to participate in the development of the initial service plan and any subsequent service plans. (4) At the resident’s request, a resident representative, family member, or other individual shall be invited to participate in all service plan meetings. (5) When the resident lacks the capacity to participate, the resident representative, as applicable to their authority, shall be invited to participate in all service plan meetings. (6) The assisted living program shall accommodate the schedules of participants in a service plan meeting when possible. B. Assessment of Condition. (1) The resident’s service plan shall be based on an assessment of the resident’s health, function, behavioral, and psychosocial status using the Resident Assessment Tool and the nursing assessment. (2) A full assessment of the resident shall be completed: (a) Within 48 hours but not later than required by nursing practice and the patient’s condition after: (i) A significant change of condition; and (ii) Each nonroutine hospitalization; and (b) At least annually. (3) When the delegating nurse determines in the nurse’s clinical judgment that the resident does not require a full assessment within 48 hours, the delegating nurse shall: (a) Document the determination and the reasons for the determination in the resident’s record; and (b) Ensure that a full assessment of the resident is conducted within 7 calendar days. (4) A review of the assessment shall be conducted every 6 months for residents who do not have a change in condition. Further evaluation by a health care practitioner is required and changes shall be made to the resident’s service plan, if there is a score change in any of the following areas: (a) Cognitive and behavioral status; (b) Ability to self-administer medications; and (c) Behaviors and communication. (5) If the resident’s previous assessment did not indicate the need for awake overnight staff, each full assessment or review of the full assessment shall include documentation as to whether awake overnight staff is required due to a change in the resident’s condition. C. Special Care Needs. The service plan shall reflect increased monitoring, intervention, and oversight, as clinically appropriate for special care needs, including: (1) Fall risk or frequent falls; (2) Pressure ulcer risk, prevention, and treatment; (3) Diabetes management; (4) Oxygen therapy; (5) Enteral feedings; (6) Foley catheter care; (7) Ostomy care; (8) Therapeutic medication levels; (9) Mental illness; and (10) Behaviors that are likely to disrupt or harm the resident or others. D. The assisted living manager, or designee, shall ensure that: (1) A written service plan or other documentation sufficiently recorded in the resident’s record is developed by staff, which at a minimum addresses: (a) The services to be provided to the resident, which are based on the assessment of the resident; (b) When and how often the services are to be provided; and (c) How and by whom the services are to be provided; (2) The service plan is developed within 30 calendar days of admission to the assisted living program; and (3) The service plan is reviewed by staff at least every 6 months, and updated, if needed, unless a resident’s condition or preferences significantly change, in which case the assisted living manager or designee shall review and update the service plan sooner to respond to these changes. #### Regulation .29 Resident Record. *COMAR 10.07.14.29* A. The assisted living manager shall ensure that an individual record or log is maintained at the assisted living program for each resident in a manner that ensures security and confidentiality, and which includes at a minimum: (1) Resident Assessment Tools; (2) Nursing assessments; (3) Medical orders; (4) Service plans; (5) Care notes; (6) Emergency data sheet; (7) Applicable advance directive and mental health advance directive; (8) Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form; (9) Monthly weights or, in accordance with the health care practitioner’s orders for weights, more or less frequently; (10) Pharmacy reviews, if appropriate; (11) Rehabilitation plans, if appropriate; and (12) Any other records related to the care and services provided to the resident. B. Readmission of a Resident. (1) A resident shall be reassessed by the delegating nurse within 48 hours of readmission to the program if the following occurs: (a) Hospitalizations or a 15-day or longer stay in any skilled facility; or (b) There is a significant change in the resident’s mental or physical status upon return to the program after an absence from the program. (2) When the delegating nurse determines in the nurse’s clinical judgment that the resident does not require a full assessment within 48 hours, the delegating nurse shall: (a) Document the determination and the reasons for the determination in the resident’s record; and (b) Ensure that a full assessment of the resident is conducted within 7 calendar days. C. The assisted living manager shall develop policies and procedures to ensure that all information relating to a resident’s condition or preferences, including any significant change as defined in Regulation .02B(81) of this chapter, is documented in the resident’s record and communicated in a timely manner to: (1) The resident; (2) The resident representative, as appropriate; and (3) Health care practitioners and staff who are involved in the development and implementation of the resident’s service plan, as appropriate. D. Resident Care Notes. (1) Appropriate staff shall write care notes for each resident: (a) On admission; (b) At least weekly; (c) With any significant changes in the resident’s condition, including when incidents occur and any follow-up action is taken; (d) When the resident is transferred from the facility to another health care facility; (e) On return from medical appointments; (f) When seen in the facility by any health care practitioner or health care provider; (g) On return from nonroutine leaves of absence; and (h) When the resident is discharged permanently from the facility, including the location and manner of discharge. (2) Staff shall write care notes that are individualized, legible, dated, timed, and signed by the writer. E. The assisted living program shall maintain a resident’s record for 5 years after the resident is discharged. F. If an assisted living program ceases operation, the assisted living program shall make arrangements to retain records as required by §E of this regulation. G. If the assisted living program changes ownership, the prior owner shall provide all written and electronic records of current residents to the new owner in a usable format prior to the issuance of the new license. H. An assisted living program shall: (1) Maintain the privacy and confidentiality of a resident’s medical records and medical information; (2) Release medical records or medical information about a resident only with the consent of the resident or resident representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (3) Maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. #### Regulation .30 Services. *COMAR 10.07.14.30* A. Meals. (1) The assisted living manager shall ensure that: (a) A resident is provided three meals in a common dining area and additional snacks during each 24-hour period, 7 days a week; (b) Meals and snacks are well-balanced, varied, palatable, properly prepared, and of sufficient quality and quantity to meet the daily nutritional needs of each resident with specific attention given to the preferences and needs of each resident; (c) At a minimum, residents have access to snacks or food supplements between breakfast and lunch, between lunch and dinner, and during the evening hours; (d) All food is prepared in accordance with all State and local sanitation and safe food handling requirements; (e) Food preparation areas are maintained in accordance with all State and local sanitation and safe food handling requirements; and (f) Portion sizes are in accordance with orders from a health care practitioner. (2) The assisted living program shall ensure that menus are nutritionally adequate by having a dietitian or nutritionist review the 4-week menu: (a) Prior to initial licensure; (b) If substantive changes beyond accepted food substitutions have been made; and (c) At least every 3 years. (3) Menus. (a) Menus shall be written at least 1 week in advance. (b) The assisted living program shall post a weekly menu in a conspicuous place that is visible to residents and other interested parties. (c) Menus shall be maintained on file, as served, for 6 months. (4) Special Diets. (a) The assisted living program staff shall: (i) Prepare or arrange for the provision of special diets as ordered by the resident’s health care practitioner or as needed by the resident’s condition; and (ii) Document special diets in the resident’s record. (b) If the diet is beyond the capability of the assisted living program, the resident or the resident’s health care practitioner shall make other arrangements for the resident’s care, or the assisted living program shall discharge the resident. B. Monitoring. The assisted living manager shall ensure that each resident is monitored on a daily basis to ensure that the resident’s service plan is being properly implemented. C. Adaptive Equipment and Assistive Devices. (1) The assisted living manager or their designee shall ensure that all adaptive equipment and assistive devices are in proper working order. (2) The assisted living manager or designee shall facilitate the repair or replacement of adaptive equipment and assistive devices, as needed. (3) Assisted living staff shall assist the resident, as needed, to utilize the adaptive equipment and assistive devices. D. Nursing Services. The assisted living manager, in consultation with the delegating nurse, shall ensure that all nursing services are provided consistent with the Nurse Practice Act, Health Occupations Article, Title 8, Annotated Code of Maryland. E. Personal Care Services. The assisted living manager shall provide or ensure the provision of all necessary personal care services, including, but not limited to, the range of assistance needed by a resident to complete the activities of daily living as defined in Regulation .02B(2) of this chapter. F. Housekeeping Services. The assisted living manager shall ensure that: (1) Housekeeping services are provided; and (2) All areas of the facility are maintained in a clean and orderly condition. G. Health Care and Social Services. The assisted living manager is responsible for facilitating access to any appropriate health care and social services for the resident as determined in the resident’s assessment, including, but not limited to: (1) Social work services; (2) Rehabilitative services, including occupational, physical, speech, and audiology therapies; (3) Home health services; (4) Hospice services; (5) Skilled nursing services; (6) Health care practitioner services; (7) Oral health care; (8) Dietary consultation and services; (9) Counseling; (10) Psychiatric services; (11) Psychological services; and (12) Other specialty health services. H. Social and Recreational Activities. (1) In accordance with the resident’s service plan, the assisted living program staff shall encourage resident participation in social and recreational activities, including: (a) Providing or arranging for transportation to these activities in accordance with the resident’s service plan; and (b) Assisting a resident with communication, interpersonal, and social skills, including managing difficult behaviors in accordance with the resident’s service plan. (2) The assisted living manager shall provide or arrange appropriate opportunities for socialization, social interaction, and leisure activities that reflect the resident’s preferences and promote the physical and mental well-being of each resident. I. Spiritual Activities. (1) The assisted living manager or designee shall facilitate access to spiritual and religious activities consistent with the preferences and beliefs of the resident. (2) The assisted living manager or designee shall provide or arrange for transportation to spiritual and religious activities in accordance with the resident’s service plan. #### Regulation .31 Medication Management and Administration. *COMAR 10.07.14.31* A. All unlicensed staff who will administer medications to residents shall have first completed the medication administration course that is taught by a registered nurse who is approved by the Maryland Board of Nursing to teach the certified medication technician course. B. The assisted living manager shall document completion of the medication technician training and certification as a medication technician by the Maryland Board of Nursing per COMAR 10.39.04 in the personnel file or other readily available record of each unlicensed staff member who administers medications. C. All medications shall be administered consistent with applicable requirements of COMAR 10.27.11. D. Self-Administration of Medication. (1) An assisted living manager shall ensure that the resident’s initial assessment process identifies whether a resident: (a) Is capable of self-administration of medication; (b) Is capable of self-administration of medication, but requires a reminder to take medications or physical assistance with opening and removing medications from the container, or both; or (c) Requires that medications be administered by the assisted living program staff or by a spouse or domestic partner of the resident in accordance with §E of this regulation. (2) For a resident who is capable of self-administration or, although capable, requires a reminder or physical assistance, as stated in §D(1)(b) of this regulation, the assisted living manager shall ensure that the resident is reassessed by the delegating nurse quarterly for the ability to safely self-administer medications with or without assistance. E. Administration of Medication by a Spouse or Domestic Partner. While residing in the same assisted living program as their spouse or domestic partner, a resident may administer medications to their spouse or domestic partner providing the following documentation is maintained in the resident’s record: (1) An initial assessment by their health care practitioner documenting the resident’s competency and ability to safely administer medications to their spouse or domestic partner; (2) Quarterly assessments by the delegating nurse documenting the resident’s continued ability to safely administer medications to their spouse or domestic partner; and (3) Current signed medical orders. F. Medication Regimen Review Upon Admission. (1) The assisted living manager shall consult within 14 calendar days of a resident’s admission with the individuals set forth in §F(2) of this regulation to review a new resident’s medication regime. (2) The medication review may be conducted by a: (a) Health care practitioner; (b) Registered nurse, who may be the delegating nurse; or (c) Licensed pharmacist. G. The purpose of the medication regimen review required by §F of this regulation is to review with the assisted living manager or designee: (1) A resident’s current medication profile, including all prescription and nonprescription over-the-counter medications and tube feedings; (2) The potential that current medications have to act as a chemical restraint; (3) The potential for any side effects; (4) The potential for adverse drug interactions; and (5) Any medication errors that have occurred since admission. H. The assisted living manager, or designee, shall ensure that the medication regimen review required by §F of this regulation is documented in the resident’s records, including any recommendations given by the reviewer. I. Pharmacy Review. (1) The assisted living manager shall arrange for a licensed pharmacist to conduct an on-site review of health care practitioner prescriptions, health care practitioner orders, and resident records at least every 6 months for any resident receiving nine or more medications, including over-the-counter and as needed (PRN) medications. (2) The pharmacist’s review shall include, but is not limited to, whether: (a) The assisted living program is in compliance with Board of Pharmacy’s requirements for packaging of medications; (b) Each resident’s medications are properly stored and maintained; (c) Each resident receives the medications that have been specifically prescribed for that resident in the manner that has been ordered; (d) The desired effectiveness of each medication is achieved based on available information, and, if not, that the appropriate authorized prescriber is so informed; (e) Any undesired side effects, potential and actual adverse drug reactions, and medication errors are identified and reported to the appropriate authorized prescriber; (f) The resident has a medical condition as documented in the resident’s records that is not currently being treated by medication; (g) There is medication use without current indication in the resident’s records of a medical condition that warrants the use of the medication; (h) There is medication overuse that is causing side effects as documented in the resident records; (i) Current medication selections result in inappropriate medication dosage; (j) The resident may be experiencing drug interactions; (k) The resident is receiving medication, either prescribed or over-the-counter medications, as well as herbal remedies that could result in drug-drug, drug-food, or drug-laboratory test interactions; (l) Administration times of medication need to be modified to address drug interactions or meal times, or both; (m) Periodic diagnostic monitoring required by certain medications have been performed; and (n) More cost-effective medications are available to treat current medical conditions. (3) The pharmacist shall document the pharmacy review as required under this section in each resident’s chart and this documentation shall be reviewed every 6 months as part of the assisted living program’s quality assurance activities as required in Regulation .13 of this chapter. J. The person conducting the on-site review under §F or G of this regulation shall recommend changes, as appropriate, to the appropriate authorized prescriber and the assisted living manager or designee. K. If a resident requires that staff administer medications as defined in Regulation .02B(3) of this chapter, and the administration of medications has been delegated to an unlicensed staff person pursuant to COMAR 10.27.11, the assisted living manager shall comply with COMAR 10.27.11 by arranging for an on-site review by the delegating registered nurse at least every 45 calendar days. The delegating nurse shall make appropriate recommendations to the appropriate authorized prescriber, and the assisted living manager or designee. L. Safe Storage of Medication. The assisted living manager, or designee, shall ensure that: (1) Medications are stored in the original dispensed container; (2) Medications are stored in a secure location, at the proper temperature; and (3) The following documentation is maintained for all prescription and over-the-counter medications prescribed to residents: (a) Name of the resident; (b) Name of the medication; (c) Reason for the medication; (d) Dose; (e) Frequency; (f) Route; (g) Authorized prescriber’s name; (h) Date of issuance; (i) Expiration date; (j) Refill limits; and (k) Directions for use. M. Medications and treatments shall be administered consistent with current signed medical orders and using professional standards of practice. N. Only sealed, unopened medication packages or individual unit dose blisters may be returned to the inventory of the pharmacy. O. Required Documentation. (1) A staff member shall record the documentation required under §L of this regulation for all residents for whom medications are administered, or who receive assistance in taking their medications, as defined by Regulation .02B(3)(b) of this chapter, at the time that the resident takes or receives medications. (2) A staff member shall record the documentation required under §L of this regulation for residents who self-administer: (a) Upon admission; or (b) When changes in the resident’s medication regimen are ordered by a health care practitioner. P. Accounting for Narcotic and Controlled Substances. (1) A qualified staff member and a witness shall count and record Schedule II through V controlled substances before the close of every shift. (2) The daily record shall account for all controlled substances documented as administered on the medication administration record. (3) All Schedule II through V controlled substances shall be maintained under a double lock system. (4) As required, the assisted living program shall obtain a Controlled Dangerous Substances registration certificate from the Department’s Office of Controlled Substances Administration. (5) The assisted living manager shall develop written policies and procedures to guard against theft and diversion of controlled substances, that include: (a) Proper storage; (b) Accountability; (c) Access; (d) Destruction; and (e) Reporting procedures. (6) Controlled substances may not be returned to the pharmacy. (7) Controlled substances in need of disposal shall be destroyed on-site at the assisted living program and their destruction shall be: (a) Conducted by two members of the staff, one of whom shall be a licensed practitioner, licensed pharmacist, registered nurse, licensed practical nurse, certified medication technician, or licensed assisted living manager; and (b) Recorded on a form supplied by the Division of Drug Control, a copy of which shall be forwarded to the Division within 10 calendar days of destruction. #### Regulation .32 Alzheimer’s Special Care Unit. *COMAR 10.07.14.32* A. Initial Approval of an Alzheimer’s Special Care Unit. An assisted living program requesting the initial approval to operate an Alzheimer’s Special Care Unit shall submit to the Department a written description of the Alzheimer’s Special Care Unit using a disclosure form developed by the Department. The description shall explain how: (1) The form of care and treatment provided by the Alzheimer’s Special Care Unit is specifically designed for the specialized care of individuals diagnosed with Alzheimer’s disease or a related dementias; and (2) The care in the Alzheimer’s Special Care Unit differs from the care and treatment provided in the nonspecial care unit. B. Approval of an Alzheimer’s Special Care Unit. (1) An assisted living program shall have written approval from the Department prior to operating an Alzheimer’s Special Care Unit. (2) An assisted living program shall have written approval from the Department of an Alzheimer's Special Care Unit prior to advertising or marketing the unit. (3) The Department will either approve or not approve the operation of the Alzheimer’s Special Care Unit. C. Substantive Changes to the Alzheimer’s Special Care Unit. (1) The written description of the Alzheimer’s Special Care Unit shall accurately reflect the current operation of the unit. (2) If any substantive changes are made to the Alzheimer’s Special Care Unit, the revised written description shall be submitted to the Department for review and approval. (3) The Department shall inform the provider of the decision of the review within 30 calendar days from the Department’s receipt of the revised written description. D. An assisted living program with an Alzheimer’s Special Care Unit shall disclose the written description of the unit to: (1) Any person on request; (2) The resident, as appropriate; and (3) The family or resident representative before admission of the resident to the Alzheimer’s Special Care Unit. E. The description of the Alzheimer’s Special Care Unit shall include: (1) A statement of philosophy or mission; (2) How the services of the unit are different from services provided in the rest of the assisted living program; (3) Staff training and staff job titles, including: (a) A description of a minimum of 6 hours of advanced cognitive impairment training for any staff who is licensed, certified, or registered under Health Occupations Article, Annotated Code of Maryland, or any staff whose job duties include providing personal care on the Alzheimer’s Special Care Unit, including: (i) 2 hours related to effective communication; (ii) 2 hours related to behavioral interventions; and (iii) 2 hours related to making activities meaningful; and (b) The number of hours of dementia-specific training provided annually for all staff by job classification and a summary of training content; (4) Admission procedures, including screening criteria; (5) Assessment and service planning protocol, including criteria to be used that would trigger a reassessment of the resident’s status before the customary 6-month review; (6) Staffing patterns, including: (a) The ratio of direct care staff to resident for a 24-hour cycle; (b) A description of how the staffing pattern differs from that of the rest of the assisted living program; and (c) Use of awake overnight staff on the unit; (7) A description of the physical environment and any unique design features appropriate to support the functioning of cognitively impaired individuals; (8) A description of activities, including frequency and type, how the activities meet the needs of residents with dementia, and how the activities differ from activities for residents in other parts of the assisted living program; (9) The assisted living program’s fee or fee structure for services provided by the Alzheimer’s Special Care Unit; (10) Discharge criteria and procedures; (11) Any services, training, or other procedures that are over and above those that are provided in the existing assisted living program; and (12) Any other information that the Department may require. F. The Department shall restrict admission or close the operation of an Alzheimer’s Special Care Unit if the Department determines that the assisted living program has not demonstrated compliance with this regulation or the health or safety of residents is at risk. #### Regulation .33 Incident Reports. *COMAR 10.07.14.33* A. Staff of the assisted living program shall complete an incident report within 24 hours of having knowledge that an incident, as defined in Regulation .02B(39) of this chapter, occurred. B. The assisted living program shall make incident reports available on the premises to the Department and any government agency designated by the Department. C. All incident reports shall include: (1) Time, date, and place; (2) Individuals present; (3) Complete description of the incident; (4) Response of the staff at the time; and (5) Notification to the: (a) Resident or, if appropriate, the resident representative; (b) Resident’s health care practitioner, if appropriate; (c) Delegating nurse; (d) Licensing or law enforcement authorities, when appropriate; and (e) Follow-up activities, including investigation of the occurrence and steps to prevent its reoccurrence. D. The assisted living program shall notify the OHCQ within 24 hours of a resident death resulting from: (1) Abuse; (2) Neglect; (3) Wandering; (4) Elopement; (5) A medication error; (6) Burns; or (7) Any injury incurred at the assisted living program. #### Regulation .34 Relocation and Discharge. *COMAR 10.07.14.34* A. Relocation within the Facility. (1) The assisted living program may not relocate a resident within the facility except in accordance with the terms and conditions of the resident agreement. (2) An assisted living program shall notify a resident and the resident representative at least 5 calendar days before a nonemergency relocation within the facility and obtain the consent of the resident or resident representative. (3) An assisted living program shall document in the resident’s record how the requirements of this regulation have been met. B. Discharge. (1) Discharge of a resident or transfer to another facility or address without the consent of the resident or the resident representative shall be in accordance with the resident agreement. (2) An assisted living program shall notify a resident or the resident representative within 30 calendar days before a non-emergency discharge. (3) In the event of an emergency, the program shall notify the resident or the resident representative as quickly as possible and document the reason for the emergency and abbreviated notice. C. The assisted living program shall consider the resident’s specific care needs and preferences in developing a safe and appropriate discharge plan. D. When the resident is discharged to another facility, the assisted living program shall provide to the receiving facility any information related to the resident that is necessary to ensure continuity of care and services, including, at a minimum, the: (1) Emergency data sheet; (2) Current medication and treatment orders; (3) Medication administration records; and (4) Most current Resident Assessment Tool. E. When the resident is discharged to home or to a non-facility setting, the assisted living program shall provide the resident and resident representative any information related to the resident that is necessary to ensure continuity of care and services, including, at a minimum, the: (1) Emergency data sheet; (2) Current medication and treatment orders; (3) Medication administration records; and (4) Most current Resident Assessment Tool. F. In the event of a health emergency requiring the transfer to an acute care facility, a copy of an emergency data sheet shall accompany the resident to an acute care facility. This data sheet shall, at a minimum, include: (1) The resident’s full name, date of birth, Social Security number, if known, and insurance information; (2) The name, telephone number, and address of the resident representative; (3) The name and telephone number of the resident’s health care practitioner; (4) The resident’s current documented diagnoses; (5) Current medications prescribed for the resident; (6) The resident’s known allergies to food or medications, if any; (7) The resident’s dietary restrictions, if any; (8) Any relevant information concerning the event that precipitated the emergency; and (9) Appended copies of: (a) Advance directives; (b) Maryland Medical Orders for Life-Sustaining Treatment (MOLST) form; (c) Powers of attorney, if any; and (d) Guardianship orders, if any. G. Within 30 calendar days of the date of discharge, the assisted living program shall: (1) Give each resident or resident agent: (a) A final statement of account; and (b) Any refunds due; and (2) Return any money, property, or valuables held in trust or custody by the assisted living program. H. If requested by a resident, a resident representative, a governmental agency, or, on its own initiative, the Office of the Attorney General may: (1) Investigate whether an abuse of a resident’s funds contributed to the decision to discharge the resident; and (2) Make appropriate referrals of the matter to other government agencies. #### Regulation .35 Resident Representative. *COMAR 10.07.14.35* A. An assisted living program shall recognize the applicable authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements under Estates and Trusts Article, Title 17, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; and (7) Any other person, if that person was designated by a resident who was competent at the time of designation, and the resident or representative has provided the assisted living program with documentation of the designation. B. Representative Payee or Other Similar Fiduciary. (1) An assisted living program staff member who serves as a representative payee for a resident may not be considered the resident representative. (2) An assisted living program shall notify the Department if an assisted living program staff member is designated as the representative payee for a resident. C. An assisted living program shall document in the resident’s record the name of the person, if any, with the authority identified in §A of this regulation or include the documentation in the record. D. An assisted living program may not recognize the authority of a resident representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by federal or State law. E. An assisted living program who commits financial exploitation of a resident shall be in violation of this chapter as well as applicable civil and criminal laws. #### Regulation .36 Resident’s Rights. *COMAR 10.07.14.36* A. Resident Bill of Rights. (1) An assisted living program shall develop a Resident Bill of Rights that, at a minimum, includes the following rights: (a) Be treated with consideration, respect, and full recognition of the resident’s human dignity and individuality; (b) Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations; (c) Receive services and supports that optimize autonomy, independence, and personal choice; (d) Actively participate in planning and developing the resident’s service plan and medical treatment; (e) Choose a pharmacy provider, if the provider can comply with the assisted living programs’ reasonable policies and procedures for patient safety in medication supply and administration; (f) Make an informed decision to accept or refuse treatment; (g) Privacy, including the right to have a staff member knock on the resident’s door before entering unless the staff member knows that the resident is asleep or there is an emergency situation; (h) Be free from mental, verbal, sexual, and physical abuse, neglect, and financial exploitation; (i) Be free from involuntary seclusion and physical and chemical restraint used in violation of this chapter; (j) Confidentiality; (k) Manage personal financial affairs to the extent permitted by law; (l) Retain and have access to legal counsel in a private setting; (m) Attend or not attend religious services as the resident chooses, and receive visits from members of the clergy; (n) Possess and use personal clothing and other personal effects to a reasonable extent, and to have reasonable security for those effects in accordance with the assisted living program’s security policy; (o) Determine dress, hairstyle, or other personal effects according to individual preference, unless the personal hygiene of a resident is compromised; (p) Meet or visit privately with any individual the resident chooses, subject to reasonable restrictions on visiting hours and places: (i) In accordance with the resident agreement; and (ii) As posted by the assisted living manager; (q) Make suggestions or complaints or present grievances on behalf of the resident, or others, to the assisted living manager, government agencies, or other persons without threat or fear of retaliation; (r) Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the resident may have; (s) Have access to the procedures for making complaints to: (i) The Long-Term Care Ombudsman Program of the Department of Aging as set forth in COMAR 32.03.02; (ii) The Adult Protective Services Program of the local department of human services; (iii) The OHCQ of the Department; and (iv) The designated protection and advocacy agency, if applicable; (t) Have access to writing instruments, stationery, and postage; (u) Receive and send correspondence without delay, and without the correspondence being opened, censored, controlled, or restricted, except on request of the resident, or written request of the resident representative; (v) Receive a prompt, reasonable response from an assisted living manager or staff to a personal request of the resident; (w) Receive notice before the resident’s roommate is changed and, to the extent possible, have input into the choice of roommate; (x) Have reasonable access to the private use of a common use telephone within the facility; (y) Retain personal clothing and possessions as space permits with the understanding that the assisted living program may limit the number of personal possessions retained at the facility for the health and safety of other residents; (z) To participate in decision making regarding transitions in care, including a transfer or discharge from a facility; and (aa) To receive notice, procedural fairness, and humane treatment when being transferred or discharged from an assisted living facility. (2) An assisted living program shall: (a) Provide the Resident Bill of Rights to all residents and resident representatives prior to or upon admission; and (b) Either: (i) Post the Resident Bill of Rights in a conspicuous place that is visible to residents, potential residents, and other interested parties; or (ii) Post a notice stating where in the facility the Resident Bill of Rights is located. B. Confidential Information. (1) Any case discussion, disclosure of health information, consultation, examination, or treatment of a resident is: (a) Confidential; (b) To be done discreetly; and (c) Not open to an individual who is not involved directly in the care of the resident, unless the resident or resident representative permits the individual to be present. (2) Except as necessary for the transfer of a resident from the assisted living program to another facility, or as otherwise required by law, the personal and medical records of a resident are confidential and may not be released without the consent of the resident or resident representative to any individual who is: (a) Not associated with the assisted living program; or (b) Associated with the assisted living program, but does not have a demonstrated need for the information. (3) The assisted living manager shall share resident information with the Department as necessary to administer this chapter. C. Work Duties. (1) A resident may not be assigned to do any work for the assisted living program without the resident’s consent and appropriate compensation, unless the resident declines to be compensated. (2) The resident’s work duties shall be described in the resident’s record. (3) The resident’s declining to be compensated shall be documented in the resident’s record. (4) The resident may, at any time, discontinue the work duties without threat or fear of retaliation. D. Adult Medical Day Care. (1) Adult day care attendance or attendance at any other structured program shall be voluntary. (2) Adult medical day care availability and policies shall be disclosed in the assisted living program’s resident agreement. #### Regulation .37 Abuse, Neglect, and Financial Exploitation. *COMAR 10.07.14.37* A. An assisted living program shall develop and implement policies and procedures prohibiting abuse, neglect, and financial exploitation of residents. B. An assisted living program may not knowingly employ an individual who has any criminal conviction or other criminal history that indicates behavior that is potentially harmful to residents, documented through either a criminal history records check or a background check. C. Reports of Abuse, Neglect, or Financial Exploitation. (1) An assisted living program or employee of an assisted living program who has witnessed, or otherwise has reason to believe, that a resident has been subjected to abuse, neglect, or financial exploitation shall report the alleged abuse, neglect, or financial exploitation within 24 hours to the: (a) Appropriate law enforcement agency; (b) Office of Health Care Quality of the Department; (c) Ombudsman within the Department of Aging or local area agency on aging; (d) Local Department of Human Services or Adult Protective Services; and (e) Assisted living manager unless they are believed to be involved with the abuse, neglect, or financial exploitation. (2) An assisted living program or an employee may be subject to a penalty imposed by the Secretary of up to $1,000 for failing to make a report required by §C(1) of this regulation within 3 days after learning of the alleged abuse, neglect, or financial exploitation. (3) A person aggrieved by the action of the Secretary under §C of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. (4) A licensed or certified individual who has knowledge of, but does not report, suspected abuse, neglect, or financial exploitation may be referred to their respective health occupation board. D. Investigations. An assisted living program shall: (1) Thoroughly investigate all allegations of abuse, neglect, or financial exploitation and maintain on-site written documentation of the investigation; and (2) Take appropriate action to prevent further incidents of abuse, neglect, or financial exploitation while the investigation is in progress. E. Investigation Reports. (1) The assisted living program or any government agency that investigates the abuse, neglect, or financial exploitation shall send a report to the: (a) Appropriate law enforcement agency; (b) Office of Health Care Quality of the Department; (c) Ombudsman within the Department of Aging or local area agency on aging; and (d) Local Department of Human Services or Adult Protective Services. (2) The entities set forth in §E(1) of this regulation may make a referral, if appropriate, to: (a) The State’s attorney’s office; or (b) The Medicaid Fraud Control Unit of the Criminal Division of the Office of the Attorney General. F. Immunity from Civil Liability. An individual who, acting in good faith, makes a report under this regulation has immunity from liability as described in Health-General Article, §19-347(g), Annotated Code of Maryland. G. Notice. The assisted living program shall post signs that set forth the reporting requirements of §C(1) of this regulation, conspicuously in the employee and public areas of the facility. #### Regulation .38 Restraints. *COMAR 10.07.14.38* A. The resident has the right to be free of restraints used in violation of this chapter. B. A protective device as defined in Regulation .02B(66) of this chapter is not considered a restraint. C. Improper Use of Chemicals or Drugs. Chemicals or drugs may not be used for residents in the following ways: (1) In excessive dose, including duplicate drug therapy; (2) For excessive duration, without adequate monitoring; (3) Without adequate indications for its use; or (4) In the presence of adverse consequences which indicate the dose should be reduced or discontinued. D. Improper Use of Physical Restraints. Residents may not be physically restrained: (1) For discipline or convenience; or (2) If a restraint is not ordered by a physician to treat the resident’s symptoms or medical conditions. E. Restraint Orders. (1) Any restraint shall be ordered by a physician and shall specify: (a) The purpose of the restraint; (b) The type of restraint to be used; and (c) The length of time the restraint shall be used. (2) A resident may not have an as-needed restraint order. (3) Orders for the use of a restraint shall be time specific. (4) A resident may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity. (5) If an order for the use of a restraint is to be continued, the order shall be renewed at least every 7 calendar days by a physician. (6) The delegating nurse shall provide training to staff in the appropriate use of the restraint ordered by the physician. F. Bed Rails. Bed rails may be considered a restraint depending upon the reason for the use of bed rails and how the bed rails are used. This determination is based upon the resident and the effect that bed rails would have upon the resident, as documented in the resident’s record. G. The program shall notify the resident’s family or the resident representative each time a restraint is used. H. When the resident is under the care of a general hospice care program licensed by the Department and is physically located in an assisted living program licensed by the Department, the general hospice program and the assisted living program shall comply with the requirements of this chapter, COMAR 10.07.21, and federal regulations. #### Regulation .39 Protection of a Resident’s Personal Funds. *COMAR 10.07.14.39* A. A resident may: (1) Manage the resident’s financial affairs; or (2) Consistent with State law, choose any individual who is willing and able to handle the resident’s financial affairs. B. An assisted living program may refuse to handle a resident’s financial affairs. C. An assisted living program may not manage a resident’s funds without an express written request from the: (1) Resident; or (2) Resident agent. D. Management of Personal Funds. On the written authorization of a resident or resident agent, an assisted living program shall hold, safeguard, manage, and account for the resident’s personal funds as specified in this regulation. E. Safeguards Required. (1) Each assisted living program shall develop adequate safeguards to secure the personal funds of a resident that are entrusted to the assisted living program. (2) An assisted living program to which $300 or more of a resident’s personal funds is entrusted shall deposit the money in an interest-bearing bank account. If an assisted living program is entrusted with a resident’s personal funds that are less than $300, the assisted living program may deposit the funds in a bank account. (3) An assisted living program that manages residents’ personal funds, regardless of the amount managed, shall maintain on behalf of the residents: (a) A bond, with the State as obligee, equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility; (b) A letter of credit, with the State as obligee, equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility; or (c) Net assets equal to the average monthly balance of all the funds held or managed by the assisted living program for the residents of the facility. (4) The bond, letter of credit, or list of assets shall be kept at the assisted living program for inspection by the Department or its designee. F. Establishment of Resident Accounts. (1) When an assisted living program manages a resident’s financial affairs, the assisted living program shall: (a) Establish and maintain a system that ensures a full, complete, and separate accounting, in accordance with generally accepted accounting principles, of a resident’s personal funds entrusted to the assisted living program; and (b) Keep the accounts of its residents separate from the accounts of the facility. (2) Bank accounts opened for residents’ personal funds by an assisted living program shall have minimal or no fees. (3) Any interest earned on the bank accounts shall accrue to the resident. (4) Any fees charged by the bank for the maintenance of the account shall be paid by the resident. G. Records of Resident Personal Funds. For all resident funds entrusted to an assisted living program, the assisted living program shall: (1) Maintain an individual record for each resident, which includes the following information for each transaction: (a) The date of the transaction; (b) The type of transaction, that is, whether it is a deposit, withdrawal, or any other transaction; and (c) The balance of funds after the completion of the transaction; (2) Make available for inspection by the resident, or, when applicable, the resident agent or resident representative, a statement of the resident’s account; and (3) Make available at the assisted living program, for audit by the Department or its designee, records pertaining to each resident’s personal funds, including the written authorization required by §D of this regulation. H. Fire and Theft Coverage. For all resident funds entrusted to an assisted living program, the assisted living program shall establish and maintain adequate fire and theft coverage to protect a resident’s funds that are on the premises of the assisted living program. I. Availability of Personal Funds. (1) A resident or, if applicable, the resident’s legally authorized representative, has the right to access funds entrusted to the assisted living program: (a) During normal business hours, if the funds are held within the facility; or (b) Within 3 banking days, if a bank, the State, or a county or municipal treasurer holds the money. (2) If an assisted living program transfers or discharges a resident, the assisted living program shall: (a) Request and follow the resident’s written instructions for transferring the resident’s funds; (b) Return, upon the resident’s or, when applicable, the resident agent’s demand, the resident’s money that the assisted living program has in its possession and have the resident or resident agent sign a receipt for the money; or (c) Make available to the resident or the resident agent, within 3 banking days, the resident’s money which is held in an account with a bank, the State, or a county or municipal treasurer. J. Ownership Change. (1) If the ownership of an assisted living program changes, the previous owner, with the approval of each resident, shall give the new owner a certified written audit of all funds that residents have entrusted to the assisted living program. (2) The new owner shall give to the previous owner a signed receipt acknowledging the receipt of the accounts. (3) The new owner shall comply with the safeguard requirements of §E of this regulation. (4) If the resident wants the new owner to hold, safeguard, manage, or account for the residents personal funds, then a new written authorization in compliance with §D of this regulation shall be executed. K. Resident Liability. A resident is not liable for any act or omission of the assisted living program concerning the finances of the assisted living program or the resident. #### Regulation .40 Misuse of Resident’s Funds. *COMAR 10.07.14.40* A. A person may not misappropriate a resident’s assets or income, including spending the resident’s assets or income against or without the consent of the resident or, if the resident is unable to consent, the resident agent. B. An individual who witnessed, or otherwise has reason to believe, that there has been an abuse of a resident’s funds shall make a complaint within 24 hours to the: (1) Appropriate law enforcement agency; (2) Office of Health Care Quality of the Department; (3) Ombudsman within the Department of Aging or local area agency on aging; and (4) Local Department of Human Services or Adult Protective Services. C. The agency that investigates the abuse of a resident’s funds shall send a report to any other agency listed under §B of this regulation that participates in the licensure or subsidizes the care of the resident. Any agency may make a referral to the State’s Attorney’s Office, or to the Medicaid Fraud Control Unit of the Criminal Division of the Office of the Attorney General, if appropriate. #### Regulation .41 Approval of Burial Arrangements for Unclaimed Deceased Residents. *COMAR 10.07.14.41* A. An assisted living program shall ascertain and document on admission of the resident, or within 14 calendar days of admission, any arrangements the resident has made, or wishes to make, with regard to burial, including, but not limited to: (1) Financial; (2) Religious; (3) Name of preferred funeral director, if any; and (4) The name, address, and relationship of any person who has agreed to claim the body of the resident or who has agreed to assume funeral or burial responsibility. B. Notification on Death. On the death of an individual who appears to be an unclaimed deceased resident, the assisted living manager or designee shall contact any person who, although not having been identified in advance as being responsible for the burial arrangements, might nevertheless at the time of death be willing to claim the body and assume responsibility. #### Regulation .42 General Physical Plant Requirements. *COMAR 10.07.14.42* A. The facility and exterior grounds, shall be kept: (1) In good repair; (2) Clean; (3) Free of any object, material, or condition that may create a health hazard, accident, or fire; (4) Free of any object, material, or condition that may create a public nuisance; and (5) Free of insects and rodents. B. Bathtubs, shower stalls, and lavatories may not be used by the staff for laundering or storing soiled linens. C. The assisted living program shall provide in the resident’s room adequate storage space for excess supplies, some personal possessions of residents, and similar items which is: (1) Protected from the elements; and (2) Secure, fixed, and locked in a manner that the resident can access without assistance or with that level of assistance normally required and readily available upon request. D. Residents may possess their own cleaning supplies and personal hygiene items if the assisted living manager and delegating nurse have determined that the products would not present a threat to the safety of the resident or others and this decision is documented in the records. The cleaning supplies and personal hygiene items shall be kept in the resident’s room and out of view of other residents when the materials are not in use. #### Regulation .43 Water Supply. *COMAR 10.07.14.43* A. Approved Source. A facility shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be accepted if it is approved by the local jurisdiction in which the program is located or a private certified vendor to be submitted with an initial licensure application. B. Adequacy. The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve all fixtures in the facility. C. Hot Water Temperature. Hot water accessible to residents shall be blended externally to the hot water generator, by either individual point-of-use control valves of the anti-scald or thermostatic mixing valve type, to a maximum temperature of 120°F and a minimum temperature of 100°F at the fixture. #### Regulation .44 Sewage Disposal. *COMAR 10.07.14.44* The facility shall be served by an approved public sewage disposal system, if available. If an approved public sewage disposal system is not available, a private sewage disposal system may be accepted if approved by the local jurisdiction in which the program is located. #### Regulation .45 Security. *COMAR 10.07.14.45* A. The facility shall provide: (1) Lockable exterior doors and windows; and (2) An effective automated device or system to alert staff to individuals entering or leaving the building. B. A facility need not use an automated alert for an exit door when the exit is staffed by a receptionist or other staff member who views and maintains a log of individuals entering and leaving the facility. #### Regulation .46 Assist Rails. *COMAR 10.07.14.46* A. An assisted living program shall provide assist rails in stairways used by residents and for all toilets, showers, and bathtubs used by residents unless, through a waiver request, the Department determines that the physical abilities of the residents make these devices unnecessary for resident safety. B. An assisted living program with a licensed capacity of 17 or more beds shall also provide assist rails on both sides of corridors used by residents. #### Regulation .47 Emergency Preparedness. *COMAR 10.07.14.47* A. The facility shall comply with: (1) All applicable local fire and building codes; and (2) The National Fire Protection Association (NFPA) 101 Life Safety Code, including Chapter 24 of NFPA 101 if the facility is a one or two family dwelling as defined by NFPA 101. B. Fire Extinguishers. An assisted living program shall: (1) Ensure that fire extinguishers are: (a) Located on each floor and adjacent to, or in, special hazard areas, such as: (i) Furnace rooms; (ii) Boiler rooms; (iii) Kitchens; or (iv) Laundries; (b) Of standard and approved types; (c) Installed and maintained to be conveniently available for use at all times; and (d) Serviced annually, as evidenced by documentation maintained on-site, by an individual or company licensed by the Maryland State Fire Marshall; and (2) Initially and at least annually instruct staff in the use of fire extinguishers. C. Emergency and Disaster Plan. (1) The assisted living program shall develop an Assisted Living Emergency Preparedness Packet in compliance with the requirements of §C(2)—(11) of this regulation, which shall be readily available to all staff. (2) The assisted living program shall develop an emergency and disaster plan that includes procedures that shall be followed before, during, and after an emergency or disaster, including: (a) Evacuation, transportation, or sheltering in-place of residents; (b) Notification of families and staff regarding the action that will be taken concerning the safety and well-being of the residents; (c) Staff coverage, organization, and assignment of responsibilities for ongoing sheltering in-place or evacuation, including identification of staff members available to report to work or remain for extended periods; and (d) The continuity of services, including: (i) Operations, planning, financial, and logistical arrangements; (ii) Procuring essential goods, equipment, and services to sustain operations for at least 72 hours; (iii) Relocation to alternate facilities or other locations; and (iv) Reasonable efforts to continue care. (3) The assisted living program shall have a tracking system to locate and identify residents in the event of displacement, an emergency, or a disaster that includes at a minimum the: (a) Resident’s name; (b) Date and time that the resident was sent to the initial alternative facility or location; (c) Name of the initial alternative facility or location where the resident was sent; and (d) Contact person and phone number for the facility where the resident was sent. (4) When the assisted living program relocates residents, the assisted living program shall send a brief medical fact sheet with each resident that includes at a minimum the resident’s: (a) Name; (b) Medical condition or diagnosis; (c) Medications; (d) Allergies; (e) Special diets or dietary restrictions; and (f) Family or legal representative contact information. (5) The brief medical fact sheet for each resident described in §C(4) of this regulation shall be: (a) Updated upon the occurrence of change in any of the required information; (b) Reviewed at least monthly; and (c) Maintained in a central location readily accessible and available to accompany residents in case of an emergency evacuation. (6) The assisted living program shall review the emergency and disaster plan at least annually and update the plan as necessary. (7) The assisted living program shall: (a) Identify a facility, facilities, or an alternate location or locations that have agreed to house the licensee’s residents during an emergency evacuation; and (b) Document an agreement with each facility or location. (8) The assisted living program shall: (a) Identify a source or sources of transportation that have agreed to safely transport residents during an emergency evacuation; and (b) Document an agreement with each transportation source. (9) Upon request, an assisted living program shall provide a copy of the facility’s emergency and disaster plan to the local emergency management organization for the purpose of coordinating local emergency planning. The assisted living program shall provide the emergency and disaster plan in a format that is mutually agreeable to the local emergency management organization. (10) The assisted living program shall identify an emergency and disaster planning liaison for the facility and shall provide the liaison’s contact information to the local emergency management organization. (11) The assisted living program shall prepare an executive summary of its evacuation procedures to provide to a resident, family member, or legal representative upon request. The executive summary shall, at a minimum: (a) List means of potential transportation to be used in the event of evacuation; (b) List potential alternative facilities or locations to be used in the event of evacuation; (c) Describe means of communication with family members and legal representatives; (d) Describe the role of the resident, family member, or legal representative in the event of an emergency situation; and (e) Notify families that the information provided may change depending upon the nature or scope of the emergency or disaster. D. Evacuation Plans. The facility shall: (1) Conspicuously post individual floor plans with designated evacuation routes on each floor; and (2) Ensure that all staff have access to the entire emergency preparedness plan. E. Orientation and Drills. (1) The assisted living program shall: (a) Orient staff to the emergency and disaster plan and to their individual responsibilities within 24 hours of the commencement of job duties; and (b) Document completion of the orientation in the staff member’s personnel file through the signature of the employee. (2) Fire Drills. (a) The assisted living program shall conduct fire drills at least quarterly on all shifts. (b) Documentation and Retention. The assisted living program shall document and maintain on file for a minimum of 2 years the: (i) Completion date and time of each drill; (ii) Names and signatures of staff who participated in the drill; (iii) Fire scenario used in the drill; (iv) Steps taken by staff during the drill; (v) Successful and non-successful actions taken by staff during the drill; and (vi) Opportunities for improvement identified as a result of the drill. (3) Semiannual Disaster Drill. (a) The assisted living program shall conduct a semiannual emergency and disaster drill on all shifts during which it practices evacuating residents or sheltering in-place so that each is practiced at least one time a year. (b) The drills may be conducted via a table-top exercise if the program can demonstrate that moving residents will be harmful to the residents. (c) The assisted living program shall document and keep on file for a minimum of 2 years the: (i) Completion date and time of each disaster drill or training session; (ii) Names and signature of staff who participated in the drill or training; (iii) Type of disaster utilized for the drill or training; (iv) Type of drill or training undertaken; (v) Steps taken or discussed by staff during the drill or training; (vi) Successful and non-successful actions taken or discussed by staff during the drill or training; and (vii) Opportunities for improvement as identified as a result of the drill. (4) The assisted living program shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency. F. Emergency Electrical Power Generator. (1) Generator Required. By October 1, 2009, an assisted living program with 50 or more residents shall have an emergency electrical power generator on the premises, unless the program meets the requirements of §F(7) of this regulation. (2) Generator Specifications. The power source shall be a generating set and prime mover located on the program’s premises with automatic transfer. The emergency generator shall: (a) Be activated immediately when normal electrical service fails to operate; (b) Come to full speed and load acceptance within 10 seconds; and (c) Have the capability of 48 hours of operation of the systems listed in §F(5) of this regulation from fuel stored on-site. (3) Test of Emergency Power System. (a) The program shall test the emergency power system once each month. (b) During testing of the emergency power system, the generator shall be exercised for a minimum of 30 minutes under normal emergency facility connected load. (c) Results of the test shall be recorded in a permanent log book that is maintained for that purpose. (d) The assisted living program shall monitor the fuel level of the emergency generator after each test. (4) The emergency power system shall provide lighting in the following areas of the facility: (a) Areas of egress and protection as required by the State Fire Prevention Code and Life Safety Code 101 as adopted by the State Fire Prevention Commission; (b) Nurses’ station; (c) Medication distribution station or unit dose storage; (d) An area for emergency telephone use; (e) Boiler or mechanical room; (f) Kitchen; (g) Emergency generator location and switch gear location; (h) Elevator, if operable on emergency power; (i) Areas where life support equipment is used; (j) If applicable, common areas or areas of refuge; and (k) If applicable, toilet rooms of common areas or areas of refuge. (5) Emergency electrical power shall be provided for the following: (a) Nurses’ call system; (b) At least one telephone in order to make and receive calls; (c) Fire pump; (d) Well pump; (e) Sewerage pump and sump pump; (f) If required for evacuation purposes, an elevator; (g) If necessary, heating equipment needed to maintain a minimum temperature of 70°F (24°C) in all common areas or areas of refuge; (h) Life support equipment; and (i) Nonflammable medical gas systems. (6) Common Areas or Areas of Refuge. If the emergency power system does not provide heat to all resident rooms and toilet rooms, the program shall provide common areas or areas of refuge for all residents. The areas shall meet the following requirements: (a) The common area or areas of refuge shall maintain a minimum temperature of 70°F (24°C); (b) Heated toilet rooms shall be provided adjacent to the common areas or areas of refuge; and (c) The program facility shall provide to the Department a written plan that defines the: (i) Specified common areas or areas of refuge; (ii) Paths of egress from the common areas or areas of refuge; and (iii) Provision for light, heat, food service, and washing and toileting of residents. (7) Applicability of Emergency Power Requirements. (a) An assisted living program shall be exempt from the requirements of this section if the program can safely transfer residents through an enclosed corridor to a building that is equipped with an electrical power generator that satisfies the requirements of §E of this regulation. (b) An assisted living program may request a waiver from the requirements of this section in accordance with the procedures outlined in COMAR 10.07.14.09 on a year-to-year basis. The program shall demonstrate in the waiver request financial hardship that would create an undue financial burden on the facility and will require the facility to cease operation of the assisted living program. (c) When the Department grants a waiver to an assisted living program for the requirements of this section, the assisted living program shall: (i) Disclose in writing to current and prospective residents that the program does not have an emergency generator; and (ii) Develop a plan to follow in the event of a loss of electrical power. #### Regulation .48 Smoking. *COMAR 10.07.14.48* A. The assisted living program shall have a written smoking policy that indicates whether or not the program permits smoking. B. When smoking is permitted, the assisted living program shall: (1) Establish smoking policies and procedures which are designed to minimize the risk of fire; (2) Provide in the policies and procedures at least the following: (a) Prohibit smoking in any hazardous location and in any room or compartment where flammable liquids, combustible gases, or oxygen are used or stored; (b) Designate smoking areas; and (c) Provide the smoking areas with ash trays of noncombustible material and safe design; (3) Provide smoking areas that comply with all applicable, local, State, and federal regulations; (4) Assess each resident who smokes to determine if assistance or supervision is needed and document the assessment in the resident’s service plan; and (5) At least annually or after a change of condition that may impact a resident’s ability to smoke, reassess a resident who smokes to determine if assistance or supervision is needed and document the reassessment in the resident’s service plan. #### Regulation .49 Common Use Areas. *COMAR 10.07.14.49* A. Multipurpose Space. (1) The assisted living program shall provide at least 35 square feet of usable multipurpose floor space per licensed bed. Multipurpose space includes: (a) Dining; (b) Living; and (c) Indoor recreational space. (2) Usable floor space in a facility does not include: (a) Service areas; (b) Administrative offices; (c) Entrance ways; (d) Closets; (e) Lockers; (f) Wardrobes; (g) Spaces where ceiling heights are less than acceptable for habitable space, as defined by the applicable local building code; or (h) Corridors. (3) The assisted living program may not restrict residents from any area constituting multipurpose space unless a comparable multipurpose space is available for resident use. B. Living Room. (1) The assisted living program shall make at least one living room available for resident use. (2) The assisted living program shall ensure that the living rooms are: (a) Well lit and ventilated; (b) Easily accessible; and (c) Furnished with a sufficient number of reading lamps, tables, chairs, or sofas based on residents’ needs. C. Outdoor Space. An assisted living program shall: (1) Provide or arrange for outside activity space; (2) Adequately light outside activity space during all times residents have access to the space; and (3) Provide the necessary security and supervision of the outside activity space sufficient to meet the needs of the residents. D. Public Toilets. (1) An assisted living program with a licensed capacity of 17 or more beds shall provide public restrooms that are: (a) Sufficient in number, and appropriately located, to serve both residents and visitors; and (b) Located close enough to activity areas to allow all residents to participate comfortably in activities and social opportunities. (2) The public toilet is not calculated in the ratio required by Regulation .50A of this chapter. E. Dining Room. An assisted living program shall provide a well lit, adequately ventilated, and appropriately furnished dining area. F. Kitchen. (1) An assisted living program shall have a kitchen that has adequate: (a) Storage, refrigerator, and freezer space for perishable and nonperishable foods; (b) Food preparation area or areas with cleanable surfaces; (c) Equipment to deliver foods at safe and palatable temperatures; (d) Space and equipment to wash, sanitize, and store utensils; (e) Space to store and clean garbage cans either within or outside the kitchen; (f) Ice-making capabilities; (g) Equipment for the preparation of food, unless all food service is catered; and (h) Equipment for serving and distributing food to residents. (2) An assisted living program with a licensed capacity of 17 or more beds shall comply with the food service facility regulations in COMAR 10.15.03. (3) An assisted living program with fewer than 17 residents is not required to comply with COMAR 10.15.03 unless required to comply by its local jurisdiction or the Department determines and directs that a program shall comply with particular provisions of COMAR 10.15.03 in order to minimize health risks to its residents. (4) An assisted living program with fewer than 17 residents: (a) Shall obtain food from sources that comply with all laws and regulations relating to food, food processing, food handling, and food labeling; (b) Shall protect food from contamination while being stored, prepared, displayed, served, or transported; (c) Shall promptly discard the following: (i) Spoiled food; (ii) Swelled, rusty, or leaky canned foods; and (iii) Food exposed to fire, smoke, or water damage; (d) May not serve to residents home-canned food or food in a hermetically sealed container as defined in COMAR 10.15.03.02B, which was prepared in a place other than a licensed food processing establishment; (e) Shall maintain potentially hazardous food as defined in COMAR 10.15.03.02B at 45°F or below, or 140°F or above, until served to residents; (f) Shall maintain food equipment, appliances, and utensils in a clean and sanitary manner and in good repair; (g) Shall maintain food contact surfaces smooth and free of breaks, open seams, cracks, chips, and pits; (h) Shall maintain floors, walls, and storage areas in a clean and sanitary manner and in good repair; (i) Shall provide refrigeration operated at or below 45°F and equipped with an indicating thermometer graduated at 2°F intervals; and (j) Shall provide freezer space operated at 0°F or less and equipped with an indicating thermometer graduated at 2°F intervals. #### Regulation .50 Resident’s Room and Furnishings. *COMAR 10.07.14.50* A. Resident Room. (1) More than two residents may not share a resident room. (2) An assisted living program shall provide at least 80 square feet of functional space for single occupancy resident rooms and 120 square feet of functional space for double occupancy resident rooms. (3) Functional space in a resident room does not include the floor area of: (a) Toilet rooms and bathing facilities; (b) Closets, wardrobes, bureaus, or lockers; (c) Entrance vestibules; or (d) The arc of any door, excluding closet doors, that opens into the room. (4) A room may not be used as a resident room if: (a) The only access to the room is through a bathroom or other resident room; or (b) In order to move from the room to a living room or dining room a person must first go outdoors. (5) For a program with a licensed capacity of 17 or more beds, a room may not be used as a resident room if in order to move from the room to a living room or dining room, an individual is required to first pass through a kitchen. (6) Resident rooms shall be for the private use of the assigned resident or residents. A resident’s room shall have a latching door and may have a lock on the resident room side of the door at the licensee’s option. (7) If a resident in a double occupancy room requests dividers, curtains, or screens between the beds to ensure privacy, the assisted living program shall furnish them. (8) A resident shall have access to a mirror either in the resident’s room or in the resident’s private bathroom, unless a health care practitioner documents in the resident’s record that access to a mirror would be detrimental to the health of the resident. (9) A resident’s room shall have window shades or their equivalent. (10) The assisted living program shall provide adequate closet or wardrobe space, conveniently located to allow each resident to keep personal clothing. B. Furnishings. Unless a resident brings personal furnishings, or as otherwise specified in the resident agreement, the assisted living program shall provide the following to each resident: (1) A bed, which may not be a rollaway, cot, or folding bed, but shall: (a) Be at least 36 inches wide; (b) Be in good repair; (c) Meet the resident’s medical needs; and (d) Include: (i) A clean mattress sized to fit the bed frame; and (ii) At least two clean pillows; (2) A bedside stand with a drawer; (3) A chair; (4) At least two dresser drawers in a chest of drawers; (5) A bedside or over-the-bed lamp; and (6) A sufficient supply of bath and bed linens. C. A competent resident may waive the resident’s right to one or all of the furnishings listed in §B of this regulation by signing a waiver and having the waiver placed in the resident’s record. D. The assisted living program shall inform a resident of all of the furnishings that the assisted living program provides. The resident may choose, at their cost, to provide a personal bed or other furnishings if they are not hazardous. #### Regulation .51 Bathrooms for Residents. *COMAR 10.07.14.51* A. Toilets. (1) An assisted living program shall provide toilets in a separate room or compartment with latching hardware for privacy. (2) Buildings with one to eight occupants shall have a minimum ratio of one toilet to four occupants. (3) Buildings with nine or more occupants shall have a minimum ratio of one toilet to four occupants and a minimum of one toilet for each floor on which a resident room is located. B. Hand Sinks. (1) Buildings with one to eight occupants shall have a minimum ratio of one hand sink to four occupants. (2) Buildings with nine or more occupants shall have a minimum ratio of one hand sink to four occupants and a minimum of one hand sink for each floor on which a resident room is located. C. Bathtubs or Showers. An assisted living program shall: (1) Provide residents with bathtubs or showers that are enclosed in a separate room or compartment with latching hardware for privacy; and (2) Have a minimum ratio of one bathtub or shower to eight occupants. #### Regulation .52 Illumination. *COMAR 10.07.14.52* A. Resident’s Room. (1) An assisted living program shall ensure that a resident’s room: (a) Is lighted by an outside window that: (i) Contains a glass surface; and (ii) Has square footage at least equal to 10 percent of the room’s required floor area; (b) Has a minimum of 60 watts or the equivalent of artificial light provided for reading; and (c) Is provided with additional artificial light as required for other uses, such as night lights to enable residents to get to the bathroom at night. (2) An assisted living program shall provide additional lighting or watts upon reasonable request by the resident or the resident’s legal representative. B. Common Use Areas. An assisted living program shall ensure that common use areas, such as entrances, hallways, inclines, ramps, cellars, attics, storerooms, kitchens, and laundries, have sufficient artificial lighting to prevent accidents and promote efficient service. C. The assisted living program shall provide sufficient light to meet the resident’s needs. #### Regulation .53 Heating, Ventilation, and Air Conditioning. *COMAR 10.07.14.53* A. An assisted living program may not use space heaters unless approved by the State or local fire authorities. B. Minimum Temperature. The facility shall have a system that provides in areas used by residents a minimum temperature of 70°F in cold weather and a maximum temperature of 80°F in hot weather. C. Temperature Control. (1) An assisted living program with a licensed capacity of one to eight beds shall provide at least one thermostat per building. (2) An assisted living program with a licensed capacity of nine or more beds shall provide for each resident’s room: (a) A thermostat; or (b) An approved mechanical device for modulating a room’s temperature, such as adjustable vanes in a hot air vent. D. An assisted living program shall: (1) Ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, and other noxious odors; and (2) Provide forced mechanical exhaust ventilation or an approved equivalent for: (a) All bathing compartments; (b) Toilet rooms; (c) Any area used for toileting; (d) Soiled utility rooms; (e) Designated smoking rooms; and (f) Other rooms, as determined by the Department. #### Regulation .54 Radiators. *COMAR 10.07.14.54* A. If steam or hot water plumbing reaches a temperature in excess of 130°F or directly powered radiating surfaces are located in areas of the facility that are accessible to residents, the assisted living program shall position or shield the radiating surfaces in a manner to prevent resident contact. B. The assisted living program shall ensure that the radiator shielding device: (1) Allows for efficient heat transfer; (2) Is constructed to minimize vermin harborage; (3) Is constructed of easily cleanable materials; and (4) Complies with all State and local fire codes. #### Regulation .55 Laundry. *COMAR 10.07.14.55* A. An assisted living program shall furnish laundry service, either on-site or off-site. B. An assisted living program shall ensure that the laundry is: (1) Adequate to meet the needs of the residents; (2) Processed and handled in a manner to prevent the spread of infection; and (3) Adequately sanitized by the use of sufficient hot water or appropriate chemical agents, or a combination of both. C. Unless otherwise agreed by the program and the resident, dry cleaning services are not considered part of required laundry services in this chapter. #### Regulation .56 Telephones. *COMAR 10.07.14.56* A. An assisted living program with a licensed capacity of one to eight beds shall provide: (1) At least one common-use telephone for residents; and (2) A posting next to the common-use telephone or in a conspicuous location that contains the telephone numbers for the local police department and fire department. B. An assisted living program with a licensed capacity of nine to 16 beds shall provide at least one common-use telephone. If there are nine or more residents that do not have private telephones in their own rooms, the assisted living program shall provide a second common-use telephone. C. An assisted living program with a licensed capacity of 17 or more beds shall provide: (1) That each resident’s room accommodates the use of the resident’s own private telephone; and (2) An adequate number of common-use telephones to accommodate those residents who do not have private telephones installed in their rooms. #### Regulation .57 Sanctions. *COMAR 10.07.14.57* A. If the Secretary determines that an assisted living program has violated this chapter, the Secretary, in addition to the sanctions set forth in this chapter, may impose one or more of the following: (1) Restrict the number of residents the assisted living program may admit in accordance with Health-General Article, §19-328, Annotated Code of Maryland; (2) Require the assisted living program to reduce the number of residents in care; (3) Restrict the levels of care for which the assisted living program may provide services; (4) Require the assisted living program, and any of its staff, to receive remedial instruction in a specific area; (5) Require the assisted living program to use the services of and cover the costs of a management firm approved by the Department; (6) Require the assisted living program to use the services of and cover the costs of a consultant to provide expertise related to: (a) One or more licensure requirements; (b) Standards of care; or (c) Discharge planning. (7) Mandate staffing patterns which specify number of personnel, personnel qualifications, or both; (8) Require the establishment of an escrow account in accordance with Health-General Article, §19-362, Annotated Code of Maryland; (9) Direct the assisted living program to correct the violations in a specific manner or within a specified time frame, or both; (10) Notify, or require the assisted living program to notify, the representative or family of any resident who is affected by the noncompliance; (11) Increase the frequency of monitoring visits during a specified period of time; or (12) Enter into an agreement with the assisted living program establishing certain conditions for continued operation, including time limits for compliance. B. If the Secretary determines that the assisted living program has violated a condition or requirement of an imposed sanction, the Secretary may suspend or revoke the license. C. Appeals. (1) An assisted living program aggrieved by the imposition of a sanction under §A(1), (2), or (3) or B of this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. (2) An assisted living program aggrieved by the imposition of a sanction under §A(8) of this regulation may appeal the Secretary’s action in accordance with Health-General Article, §§19-364 and 19-367, Annotated Code of Maryland. (3) This section does not, however, create an appeal for a decision made under Regulation .23A of this chapter. #### Regulation .58 Civil Money Penalties. *COMAR 10.07.14.58* A. The Secretary may impose a civil money penalty on a person if: (1) The person maintains or operates an unlicensed assisted living program; (2) A deficiency or an ongoing pattern of deficiencies exists in the assisted living program; or (3) The person falsely advertises a program in violation of Regulation .06B(2) of this chapter. B. In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the residents of the program that is caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of the program to correct, the deficiency or deficiencies; and (5) An assisted living program’s prior history of compliance. C. If the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the program of the deficiency or deficiencies and may: (1) Impose a per day civil money penalty until sustained compliance has been achieved; (2) Permit the program the opportunity to correct the deficiencies by a specific date; or (3) Impose a per instance civil money penalty for each instance of violation. D. If the Department permits a program the opportunity to correct the deficiencies by a specific date, and the program fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. E. If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the: (1) Deficiency or deficiencies on which the order is based; (2) Amount of civil money penalties to be imposed; and (3) Manner in which the amount of civil money penalties imposed was calculated. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. #### Regulation .59 Amount of Civil Money Penalties. *COMAR 10.07.14.59* A. A civil money penalty imposed on a person under this chapter may not exceed the amounts identified in Health-General §19-1809, Annotated Code of Maryland. B. In setting the amount of the civil money penalty under this chapter, the Secretary shall consider the following factors: (1) Nature, number, and seriousness of the deficiencies; (2) The degree of risk to the health, life, or safety of the residents of the program that is caused by the deficiency or deficiencies; (3) The efforts made by, and the ability of, the program to correct the deficiency or deficiencies; (4) Whether the amount of the civil money penalty will jeopardize the financial ability of the program to continue operation as a program; and (5) Other factors as justice may require. C. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. #### Regulation .60 Criminal Money Penalties — Hearings. *COMAR 10.07.14.60* A. A hearing on the appeal shall be held consistent with the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter. #### Regulation .61 Criminal Penalties. *COMAR 10.07.14.61* A. Operating Without a License. (1) A person may not knowingly and willfully operate, maintain, or own an assisted living program without a license. (2) A person who violates §A(1) of this regulation is guilty of a felony and on conviction is subject to: (a) For a first offense, a fine not exceeding $10,000, imprisonment not exceeding 5 years, or both; and (b) For a subsequent offense, a fine not exceeding $20,000, imprisonment not exceeding 5 years, or both. (3) If the Department finds a credible allegation that an assisted living program is operating without a license, the Department, or the Office of Health Care Quality, shall investigate whether residents in the assisted living program have been subjected to neglect, abuse, or financial exploitation. (4) On receipt of a credible allegation, or after an investigation that results in a finding that residents in an unlicensed assisted living program have been subjected to neglect, abuse, or financial exploitation, the person operating the unlicensed program shall be subject to immediate prosecution under §A(2) of this regulation. (5) If the person operating an unlicensed assisted living program fails or refuses to cooperate fully in an investigation by the Department, or the Office of Health Care Quality, conducted under §A(3) of this regulation, the person operating the unlicensed assisted living program shall be subject to immediate prosecution under §A(2) of this regulation. (6) If the Department finds, after an investigation conducted under §A(3) of this regulation, that there is no reason to believe that residents in the assisted living program operating without a license have been subject to financial exploitation, neglect, or abuse: (a) The Department shall provide written notice to the unlicensed assisted living program that the program shall come into compliance with licensure requirements within 30 days after receipt of the written notification; and (b) The person operating the program may not be subject to prosecution under §A(2) of this regulation if the person: (i) Has promptly and in good faith submitted a complete application to the Department for an assisted living program license; (ii) Is awaiting a decision from the Department regarding the application; and (iii) Has not been denied an assisted living program license on a prior occasion. (7) In recommending the amount of the criminal penalty under §A(2) of this regulation, the State shall consider factors including the nature, number, and seriousness of the violations. (8) The Department, the Attorney General, a State’s Attorney, or a local health officer may petition a circuit court for injunctive relief against the operation of an assisted living program operating without a license. (9) A violation of §A(1) of this regulation shall be a violation of the Consumer Protection Act. B. Advertisement and Representation of an Assisted Living Program. (1) A person may not advertise, represent, or imply to the public that an assisted living program is authorized to provide a service that the program is not licensed, certified, or otherwise authorized by the Department to provide when the license, certificate, or authorization is required under this subtitle. (2) A person may not advertise an assisted living program in a misleading or fraudulent manner. (3) A person who violates §B(1) of this regulation is subject to a civil money penalty imposed by the Secretary not exceeding $10,000 for each offense. (4) In setting the amount of a civil money penalty on the program under §B(1) of this regulation, the Secretary shall consider factors including the nature, number, and seriousness of the violations and the ability of the assisted living program to pay the penalty. C. Referral to an Assisted Living Program Operating Without a License. (1) A person may not willfully and knowingly refer another person to an assisted living program that is operating without a license. (2) A person who violates §C(1) of this regulation is subject to the following civil penalties: (a) For a first offense, a civil penalty not exceeding $1,000; (b) For a second offense, a civil penalty not exceeding $2,000; or (c) For a third or subsequent offense, a civil penalty not exceeding $3,000. (3) The Secretary shall remit all civil penalties collected under this regulation to the Office of Health Care Quality for the purposes of carrying out the provisions of Health-General Article, §19–1813, Annotated Code of Maryland. #### Regulation .62 Health Care Quality Account. *COMAR 10.07.14.62* A. The Department shall establish a health care quality account in the Department for assisted living programs. B. The health care quality account shall be funded by civil money penalties paid by assisted living programs. C. The Department shall use funds from the health care quality account to improve the quality of care in assisted living programs. D. Expenditure of funds may include, but is not limited to, the following: (1) Funding for the establishment and operation of a demonstration project; (2) A grant award; (3) Relocation of residents in crisis situations; (4) Provision of educational programs to assisted living programs, the Office of Health Care Quality, other government, professional, or advocacy agencies, and consumers; and (5) Any other purpose that will directly improve quality of care. E. Suggestions for the use of funds may be submitted to the Department from: (1) Members of the public; (2) Advocacy organizations; (3) Government agencies; (4) Professional organizations, including trade associations; (5) Assisted living programs; and (6) Assisted living associations. F. Decision on Expenditure of Funds. (1) The Department, in its sole discretion, shall decide how to spend funds from the health care quality account. (2) The Department’s decision to spend funds or not to spend funds for a specific project or purpose is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and therefore may not be appealed. #### Regulation .63 Emergency Suspension. *COMAR 10.07.14.63* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action. B. The Department shall deliver a written notice to the assisted living program: (1) Informing the program of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the assisted living program has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the assisted living program of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is suspended by emergency action: (1) The assisted living program shall immediately cease the use of all previously issued assisted living program licenses and return all paper licenses to the Department; (2) The assisted living program shall stop providing assisted living services immediately; (3) The assisted living manager or their designee shall notify the residents and resident representatives of the suspension and make every reasonable effort to assist them in making safe and appropriate discharge plans, including to other licensed assisted living programs; and (4) The OHCQ shall immediately notify the following entities of the emergency action: (a) Ombudsman within the Department of Aging or local area agency on aging; and (b) Local Department of Human Services or Adult Protective Services. E. In the event of an emergency suspension, the Department may assist in the relocation of residents. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing consistent with Regulation .65 of this chapter. G. Show Cause Hearing. (1) In addition to the right to request a hearing consistent with Regulation .65 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension. (2) If requested in writing, the show cause hearing shall be held promptly within a reasonable time after the effective date of the order of summary suspension. The time limit for filing an appeal with the Office of Administrative Hearings to obtain an evidentiary hearing shall be followed by the filing of a request for a show cause hearing. (3) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension. (4) The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who: (a) Shall determine procedural issues; (b) May impose reasonable time limits on each party’s oral argument; and (c) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. (5) At the conclusion of the show cause hearing, the Secretary or the Secretary’s designee may: (a) Affirm the order of summary suspension; (b) Rescind the order of summary suspension; (c) Enter into a consent order; or (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (6) After the show cause hearing, if the Secretary or the Secretary’s designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings consistent with Regulation .65 of this chapter. H. Hearing. (1) The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .65 of this chapter and issue a proposed decision within the time frames set forth in COMAR 28.02.01. (2) An aggrieved person may file exceptions pursuant to COMAR 10.01.03. (3) The Secretary shall make a final decision pursuant to COMAR 10.01.03. (4) If the Secretary’s final decision does not uphold the emergency suspension, the assisted living program may resume operation. #### Regulation .64 Revocation of License. *COMAR 10.07.14.64* A. The Secretary, for cause shown, may notify the assisted living program of the Secretary’s decision to revoke the assisted living program’s license. The revocation shall be stayed if a hearing is requested. B. The Department shall notify the assisted living program in writing of the following: (1) The effective date of the revocation; (2) The reason for the revocation; (3) The regulations with which the assisted living program has failed to comply that form the basis for the revocation; (4) That the assisted living program is entitled to a hearing, if requested, and to be represented by counsel; (5) That the assisted living program shall stop providing services on the effective date of the revocation if the assisted living program does not request a hearing; (6) That the revocation shall be stayed if a hearing is requested; and (7) That the assisted living program is required to surrender its license to the Department if the revocation is upheld. C. The assisted living manager or their designee shall: (1) Notify the residents and residents’ representatives of the revocation; (2) Make every reasonable effort to assist residents and resident representatives in making safe and appropriate discharge plans, including to other licensed assisted living programs; and (3) Immediately notify the following entities of the revocation: (a) Ombudsman within the Department of Aging or local area agency on aging; and (b) Local Department of Human Services or Adult Protective Services. D. OHCQ shall notify the following entities of the revocation: (a) Ombudsman within the Department of Aging or local area agency on aging; and (b) Local Department of Human Services or Adult Protective Services. E. The Department may assist in the relocation of residents or require the assisted living program to use the services of and cover the costs of a consultant to arrange safe and appropriate discharges for residents. F. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary’s action by filing a request for a hearing in accordance with Regulation .65 of this chapter. #### Regulation .65 Hearings. *COMAR 10.07.14.65* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary’s action. The request shall include a copy of the Secretary’s action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03 and 28.02.01. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.18. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.18J. ### Chapter 15 — Application for Hospitals and Related Institutions **Authority:** Health-General Article, §§19-320 and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: August 29, 1983 (10:17 Md. R. 1521) **Administrative History:** Regulation .01 amended effective February 12, 2007 (34:3 Md. R. 297) **Administrative History:** Regulation .01B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .02 amended effective February 12, 2007 (34:3 Md. R. 297); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03 repealed effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03A amended effective December 20, 1993 (20:25 Md. R. 1947); February 12, 2007 (34:3 Md. R. 297); January 20, 2014 (41:1 Md. R. 13) #### Regulation .01 Definitions. *COMAR 10.07.15.01* A. In this chapter, the following terms have the meaning indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Health care facility within a correctional institution” means a specified area within the correctional institution in which general and clinical health care services are provided to inmates in the custody of the Division of Corrections. (3) “Intermediate care facility for Individuals with Intellectual Disabilities or persons with related conditions (ICF/IID)” means a facility which provides residential care, treatment, or custody for the intellectually disabled. (4) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (5) Related Institution. (a) “Related institution” means an organized institution, environment, or home that: (i) Maintains conditions or facilities and equipment to provide domiciliary, personal, or nursing care for two or more unrelated individuals who are dependent on the administrator, operator, or proprietor for nursing care or the subsistence of daily living in a safe, sanitary, and healthful environment; and (ii) Admits or retains the individual for overnight care. (b) “Related institution” does not include: (i) An adult residential environment or home that is certified by the Department of Human Services; (ii) A nursing facility or visiting nurse service that is conducted only by or for adherents of a recognized church or religious denomination, in accordance with tenets and practices that include reliance on treatment by spiritual means alone for healing; or (iii) Any sheltered housing for the elderly, as defined in Article 70B, §1, Annotated Code of Maryland, that is certified by the Department of Aging, unless the housing provides for more than 11 individuals in one building that does not have more than one apartment unit, or if there are apartment units in the building, in one apartment unit. (6) “Residential treatment center for emotionally disturbed children and adolescents” means a facility which houses two or more non-related children or adolescents referred for treatment upon the recommendation of a physician. The overall program must be approved by the Maryland Department of Health, the Department of Human Services, and the State Department of Education. (7) “Secretary” means the Secretary of Health. #### Regulation .02 Application Requirements. *COMAR 10.07.15.02* A. Any person desiring to open a related institution or to continue the operation of a related institution shall file an application with the Secretary, on a form provided by the Secretary. B. Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency and names of their board members shall be submitted. C. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee’s. D. The names of persons holding 2 percent or more of the stock or assets shall be disclosed. #### Regulation .03 Fee Assessment — Repealed. *COMAR 10.07.15.03* ### Chapter 16 — Limited Private Inpatient Facilities **Authority:** Health-General Article, §§10-501—10-511, Annotated Code of Maryland **Administrative History:** Effective date: December 10, 2015 (42:24 Md. R. 1504) **Administrative History:** Regulation .05B,G,I amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .23 adopted effective December 19, 2016 (43:25 Md. R. 1384) #### Regulation .01 Scope. *COMAR 10.07.16.01* The purpose of this chapter is to: A. Outline the licensing, site, and staffing requirements for a provider of limited private inpatient facility services; and B. Provide a flexible model of service delivery and oversight. #### Regulation .02 Definitions. *COMAR 10.07.16.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) "Administration” means the Behavioral Health Administration. (2) “Department” means the Maryland Department of Health or its designee. (3) “Facility” means a limited private inpatient facility. (4) “Facility service plan” means a statement of the facility’s mission, vision, scope, and purpose, as well as all specific requirements detailed under Regulation .10 of this chapter. (5) “Individual treatment plan” means the plan prepared according to the requirements outlined in: (a) Health-General Article, §10-706, Annotated Code of Maryland; and (b) COMAR 10.21.03. (6) “Joint Commission” means a voluntary national healthcare accreditation service recognized for Medicare certification purposes by Public Law 89-97 and for Maryland State licensure purposes by Health-General Article, §19-2302, Annotated Code of Maryland. (7) “License” means a license issued by the Department to operate a limited private inpatient facility in this State. (8) “Licensed nurse” means a practical nurse or registered nurse licensed by the Board of Nursing under the provisions of Health Occupations Article, Title 8, Annotated Code of Maryland. (9) Limited Private Inpatient Facility. (a) “Limited private inpatient facility” means a private inpatient treatment facility that provides mental health evaluation and treatment to adults 24 hours per day. (b) “Limited private inpatient facility” does not include: (i) A facility licensed to provide mental health services under authority of a statute other than Health-General Article, §§10-501—10-511, Annotated Code of Maryland; or (ii) A facility that bills for reimbursement under the Medical Assistance Program. (10) “Mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to provide the mental health service: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (11) “Secretary” means the Secretary of Health. (12) Usable Square Feet. (a) “Usable square feet” means physical space that is available for resident use. (b) “Usable square feet” does not include: (i) Service areas; (ii) Administrative offices; (iii) Entrance ways including the space where a door swings open; (iv) Closets, lockers, and wardrobes; (v) Spaces where ceiling heights are less than acceptable for habitable space, as defined by the applicable local building code; or (vi) Corridors. #### Regulation .03 Incorporation by Reference. *COMAR 10.07.16.03* A. In this chapter, the following is incorporated by reference. B. Document Incorporated. “Standards for Behavioral Health Care, 2013 Edition, The Joint Commission, One Renaissance Blvd., Oakbrook Terrace, Illinois 60181”. #### Regulation .04 Eligibility. *COMAR 10.07.16.04* A. An individual is eligible for limited private inpatient facility services if the individual: (1) Requires 24-hour inpatient mental health evaluation and treatment services but does not require acute or long-term psychiatric hospital services; and (2) Has stated a willingness to comply with program rules. B. An individual is not eligible for limited private inpatient facility services if the individual: (1) Has a sole diagnosis of substance abuse, intellectual disability, or dementia; (2) Is in need of immediate involuntary inpatient psychiatric admission; (3) Is medically unstable as determined by an individual authorized under Health Occupations Article, Annotated Code of Maryland, to make medical determinations; or (4) Does not meet the eligibility criteria under §A of this regulation. #### Regulation .05 Licensure Process. *COMAR 10.07.16.05* A. An applicant shall obtain a license from the Department before providing services. B. Initial and Renewal Licensure. In order to be licensed as a limited private inpatient facility, the facility shall: (1) File an initial application with the Department that: (a) Is on the written or electronic form approved by the Department with the requirement that all questions are answered and all required documents are attached; and (b) Includes documentation of: (i) Fire, liability, and hazard insurance coverage on the building in which the facility is located; (ii) Compliance with relevant federal, State, or local ordinances, laws, regulations, and orders, including zoning and safety; and (iii) Accreditation as a limited private inpatient facility or comparable facility by the Joint Commission under its Standards for Behavioral Health Care; (2) Be subject to: (a) An initial survey to determine compliance with all appropriate statutes or regulations related to zoning, construction, fire safety, food service, and any other applicable codes; and (b) The investigation of complaints and incidents by the Department; (3) Submit a facility service plan as required by Regulation .10 of this chapter; and (4) Submit all required fees for licensure as specified in §I of this regulation. C. An application filed on behalf of a corporation, association, or governmental unit or agency shall: (1) Be made by two officers of the corporation, association, or governmental unit or agency; and (2) Include the: (a) Names of all Board members; (b) Names of persons holding 2 percent or more of the stock or assets; and (c) Ownership of property, real estate, and equipment, if other than the licensee’s. D. Display of License. The facility shall visibly post the facility’s license in a public area in the facility. E. The facility shall immediately notify the Department in writing of any change in the information the licensee had submitted with the most recent application, including the program service plan. F. To ensure the completion of any review or inspection by the Department of any major renovations, any construction of resident care areas, or the establishment of a medical service as defined under Health-General Article, §19-120, Annotated Code of Maryland, that has not previously been provided by the facility, the facility shall notify the Department 60 days before the facility begins to accept occupancy or begins operation. G. Renewal of License. (1) An application on the written or electronic form provided by the Department for the renewal of the license shall be made by an accredited facility within 30 calendar days of the exit date of the triennial survey conducted by the Joint Commission. (2) The Department shall grant a renewal license to an applicant to operate if the applicant submits: (a) A completed application for license renewal with the required fees as specified by the Joint Commission; (b) A copy of the triennial survey report; (c) A copy of the corrective actions taken for standards not met; and (d) A copy of the certificate for accreditation by the Joint Commission. H. Loss of Accreditation. (1) In the event of the loss of accreditation and the conclusion of all appeals to the Joint Commission, the facility may continue to be licensed only until the facility promptly arranges for the safe discharge of each resident to another facility or to appropriate outpatient services. The facility shall cease operation upon the discharge of all residents. (2) When performing surveys, whether based on loss of accreditation, complaints received, or incidents reported, the Department shall determine compliance or noncompliance based on: (a) Applicable State and federal law; and (b) The Standards for Behavioral Health Care. I. License Fees. (1) A facility shall submit a written or electronic application on a form approved by the Department along with the fee established in this regulation. (2) A facility that has filed an application for accreditation that meets the requirements for a provisional license shall: (a) Submit a $500 nonrefundable license fee payable to the Department; and (b) On receiving accreditation, pay an additional $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department. (3) A facility shall submit a $1,500 nonrefundable license fee per accreditation period of 3 years, payable to the Department. J. Provisional License. (1) A facility that submits documentation showing the facility has applied to the Joint Commission for accreditation but has not yet been accredited at the time of application but otherwise meets the requirements for licensure shall be issued a provisional license. (2) The provisional license shall be issued for a period of not greater than 1 year from issuance. (3) A facility issued a provisional license shall be subject to subsequent surveys by the Department to determine compliance with this chapter and applicable standards of the Joint Commission until accreditation is awarded. (4) If the Joint Commission denies accreditation to a facility before the expiration of the provisional license, the facility shall cease operations upon the prompt and safe discharge of all residents. #### Regulation .06 Duration of License. *COMAR 10.07.16.06* A. The Secretary shall issue a license to an accredited facility for the term of the facility's accreditation. B. The Secretary shall issue a provisional license to a non-accredited facility that otherwise meets the requirements for licensure for a term not to exceed 1 year with the requirement that the facility shall become accredited within that 1-year period or cease operations. #### Regulation .07 Separate License Required. *COMAR 10.07.16.07* A. A separate license is required for facilities maintained on separate premises, even if both facilities are operated under the same management. B. A separate license is not required for separate buildings on the same grounds. #### Regulation .08 Inspections. *COMAR 10.07.16.08* A. A facility shall be open to inspection by the Department at all times for the purpose of quality oversight and investigation of complaints or incidents. B. The facility’s administrative and medical records shall be available for review and for copying by the Department. C. New Facilities. (1) A facility that is issued a provisional license shall be subject to inspections by the Department every 6 months and at any other time to determine compliance with: (a) This chapter; and (b) The Standards for Behavioral Health Care. (2) If the facility has not attained accreditation by the Joint Commission within 1 year after beginning operations or has had its application for accreditation rejected, the facility shall: (a) Cease operations; and (b) Be subject to inspection to insure that all residents are receiving care and treatment in accordance with their needs as a safe discharge is arranged. D. A facility shall be open to inspection by the Department to follow up on the findings identified in the accreditation report of the Joint Commission. #### Regulation .09 Complaint Investigations. *COMAR 10.07.16.09* A. To resolve expeditiously a complaint that alleges the existence of any non-life-threatening deficiency: (1) The Department shall refer the complaint directly to the facility; and (2) The facility shall: (a) Conduct an internal investigation into the complaint; and (b) Submit the investigation and supportive evidence to the Department within 30 days of the receipt of the complaint. B. If the Department determines that the facility has not satisfactorily addressed the referred complaint or if the complaint alleges the existence of a serious or life-threatening deficiency, the Department shall conduct an independent investigation using the standards: (1) Of the Joint Commission; or (2) Adopted by the Secretary under this subtitle. C. Issues relating to the practice of medicine or the licensure or conduct of a health professional shall be referred to the: (1) Facility; and (2) Appropriate licensure board for resolution. #### Regulation .10 Facility Service Plan. *COMAR 10.07.16.10* A. The limited private inpatient facility shall provide services in accordance with the facility service plan submitted to and approved by the Department. B. A written facility service plan shall include at a minimum: (1) The rationale for the facility including discussion of the organization’s mission, vision, and philosophy for provision of services; (2) The range of services that the facility will provide; (3) The populations to be served, including age groups and other relevant characteristics, and the number of individuals that the program expects to serve; (4) The composition of the facility's governing body, board of directors, or advisory committee, whichever applies; (5) A description of staff or care providers necessary to provide the planned services and any necessary training requirements; (6) The facility’s goals, objectives, and expected outcomes; and (7) A detailed scope or description of services offered. C. The administrative head of the licensee shall assure that the facility service plan is reviewed by its governing body and updated at least every 3 years. D. If the licensee makes any changes to its facility service plan, the licensee shall submit its revised facility service plan for the Department’s approval before implementation of the changes. #### Regulation .11 Staffing. *COMAR 10.07.16.11* A. Required Staff. The facility director shall ensure that the facility’s staff is sufficient in numbers and qualifications to provide clinically appropriate services to the individuals served and includes, at a minimum: (1) A facility director that is responsible for the programmatic and administrative services of the facility under the direction of the governing body; (2) A clinical director who: (a) Is a psychiatrist or psychologist who receives medical supervision by a psychiatrist; and (b) Has overall responsibility for clinical services, including, at a minimum: (i) Establishing and maintaining appropriate standards for diagnosis and treatment, including therapeutic modalities and prescribing practices; (ii) Medical aspects of quality management; and (iii) Ensuring adequate clinical supervision of treatment staff; (3) A multidisciplinary licensed mental health professional staff that: (a) Provides evaluation and treatment services; and (b) Is in addition to the limited private inpatient facility psychiatrist; (4) A licensed nurse to provide for medication management, treatments, and other health care needs; (5) Other direct care employees to provide for the treatment and monitoring of residents as required by the resident’s individual treatment plan; (6) A physician to provide somatic medical services as required by the clients; and (7) Maintenance and housekeeping staff who are trained and qualified to provide a well-maintained, safe, and sanitary environment for residents served by the program. B. Staff Training. Before providing services to residents, staff shall receive orientation and annual training as designated by the facility service plan including, at a minimum, training in: (1) Crisis intervention and de-escalation techniques; (2) Suicide prevention, including but not limited to identification of warning signs and symptoms; (3) The facility’s disaster and fire safety plan; (4) First aid, CPR, and emergency medical procedures; and (5) Individual rights, as set forth in Health-General Article, Title 10, Subtitle 7, Annotated Code of Maryland. #### Regulation .12 Physical Environment Requirements. *COMAR 10.07.16.12* A. A limited private inpatient facility shall have a building that: (1) Meets all relevant federal, State, or local ordinances, laws, regulations, and building codes; and (2) Provides sufficient space for group and individual therapies, dining equipped with tables and chairs for resident meal service, and administrative services. B. The areas of the facility shall: (1) Be well-lit and adequately ventilated; (2) Be easily accessible; (3) Be maintained in good repair, safe, clean, and free of insects and rodents and hazards; (4) Provide a central heating system that can maintain the facility at a comfortable temperature; (5) Be furnished with sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils for use by the residents; (6) Be equipped with working smoke detectors and fire extinguishers and meets all requirements of the Maryland State Fire Code; (7) Provide a secure storage area for medications if a resident has been determined capable of self-administration of medication and for residents’ funds and valuables; (8) Have a telephone in the residence where residents can make calls and speak privately; (9) Provide a space where residents may visit privately with friends and family; and (10) Provide adequate general use space for therapy, activities, and recreation. C. Bedroom Area. The facility shall ensure that a bedroom has: (1) A minimum of: (a) 80 usable square feet for a single bedroom; and (b) 180 usable square feet for a double-occupancy bedroom; (2) A door; (3) Closet space and two drawers in a chest or dresser per resident; (4) Window coverings for privacy; (5) A bed with a clean mattress and pillow; (6) A locked drawer or other secured storage for resident’s personal belongings; and (7) No more than two residents per bedroom. D. Toilet and Bathing Facilities. The facility shall ensure that the facility provides easily accessible and conveniently located toilet and bathing areas that allow for individual privacy and that: (1) Are supplied with hand soap, toilet tissue, and hand towels or an electric hand dryer; (2) Provide hot and cold running water with hot water being a minimum of 100°F and a maximum of 120°F; (3) Are equipped with operable mechanical exhaust ventilation; and (4) Provide at least: (a) One hand sink and one toilet for every 8 residents; and (b) One tub or shower for every 12 residents. E. The facility shall ensure that a resident is provided per week, or more frequently if necessary or if requested by the resident, with at least: (1) Two sets of linens; (2) Two towels; and (3) Two washcloths. F. The facility shall provide for personal privacy in all bathrooms and in multiple occupancy bedrooms unless otherwise determined in the resident’s individual treatment plan. #### Regulation .13 Emergency Procedures. *COMAR 10.07.16.13* A. The program shall develop an emergency plan and procedures that shall be followed in the event of an internal or external emergency. B. The emergency plan and procedures shall; (1) Be updated annually; and (2) Include: (a) Easily accessible emergency telephone numbers posted at or near a telephone for: (i) Fire; (ii) Police; (iii) Ambulance; (iv) Poison control; and (v) The program’s on-call staff; (b) An emergency evacuation procedure that is explained to the residents and practiced by residents and staff on all shifts at a minimum of once every 3 months; (c) Provisions for emergency lighting and fire detection and suppression systems operable during loss of power as required by the Maryland State Fire Code; (d) A 3-day emergency food and water supply; and (e) A relocation plan in the event that the facility is partially or entirely vacated, which shall include: (i) A plan for transportation of the residents, at the facility’s expense, to relocate the residents; (ii) A process for transfer of the medical records information for the residents in a manner to protect the residents’ privacy; (iii) A system to track where and how the resident was transported; (iv) How families will be notified, if desired by the resident; and (v) Provisions that provide for any other associated costs at the facility’s expense. #### Regulation .14 Dietary Services. *COMAR 10.07.16.14* A. The facility shall ensure sufficient numbers of trained and qualified staff to meet the nutritional needs of residents served by the facility. B. Nutritional Needs. The facility shall ensure that: (1) A resident is provided three meals in a common dining area and additional snacks during each 24-hour period, 7 days a week; (2) Meals and snacks are well-balanced, varied, palatable, properly prepared, and of sufficient quality and quantity to meet the daily nutritional needs of each resident with specific attention given to the preferences and needs of each resident; (3) All food is prepared in accordance with all State and local sanitation and safe food handling requirements; (4) Food preparation areas are maintained in accordance with all State and local sanitation and safe food handling requirements; (5) Residents have access to snacks during the evening hours; and (6) Staff prepares or arranges for the provision of therapeutic or special diets as ordered by the resident's physician or as needed by the resident's condition. C. The facility shall ensure that menus are: (1) Written at least 1 week in advance with portion sizes to meet the resident’s dietary needs; and (2) Maintained on file, as served, for 2 months. D. Dining Room. A facility shall provide a well-lit, adequately ventilated, and appropriately furnished dining area. E. Food Service. (1) A facility shall have a kitchen that has adequate: (a) Storage, refrigerator, and freezer space for perishable and nonperishable foods; (b) Food preparation area or areas with cleanable surfaces; (c) Equipment to deliver foods at safe and palatable temperatures; (d) Space and equipment to wash, sanitize, and store utensils; (e) Space to store and clean garbage cans; (f) Ice-making capabilities; (g) Equipment for the preparation of food; and (h) Equipment for serving and distributing food to residents. (2) A facility’s dietary services shall be licensed by the local health department and comply with the requirements of COMAR 10.15.03. #### Regulation .15 Resident’s Rights. *COMAR 10.07.16.15* A facility shall: A. Explain to a resident their rights as set forth in Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland; B. Provide, in writing, information regarding an individual’s rights as outlined in §A of this regulation to a resident; and C. Prominently display, in accessible centralized locations, the individual’s rights as outlined in §A of this regulation. #### Regulation .16 Records. *COMAR 10.07.16.16* A. The facility shall, either manually or electronically: (1) Establish a record for a resident; and (2) Ensure that entries in the record are dated, signed, and include the signer's degree or license, or if the signer has no degree or license, the signer's staff position. B. The facility shall ensure that residents’ records are: (1) Maintained in a manner that is consistent with the medical records confidentiality and disclosure requirements of: (a) Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (b) Relevant federal statutes and regulations, including the Health Insurance Portability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164; (2) Located so that the records are convenient and available to designated staff; (3) Managed by a designated staff member who is responsible for appropriate records control, including storage, security, and indexing of records; and (4) Subject to the requirements of confidentiality laws and regulations, are made available to the Department as necessary to carry out required activities. #### Regulation .17 Reporting of Deaths. *COMAR 10.07.16.17* Upon the death of an individual in the facility, the administrative head of the facility shall: A. Submit a written report to the Department within 5 working days of the death; and B. Use the form required by the Administration. #### Regulation .18 Denial or Revocation of Approval. *COMAR 10.07.16.18* A. The Secretary may deny or revoke the license of a limited private inpatient facility that: (1) Does not comply with: (a) Health-General Article, §§10-501—10-511, Annotated Code of Maryland; (b) Health-General Article, §§10-701—10-713, Annotated Code of Maryland; or (c) The provisions of this chapter; (2) Loses accreditation by the Joint Commission; or (3) Fails to be awarded accreditation within 1 year of the issuance of a provisional license by the Department. B. A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. C. A facility that has lost or been denied accreditation by the Joint Commission may operate pending appeal only as permitted by this chapter. #### Regulation .19 Sanctions. *COMAR 10.07.16.19* A. If the Secretary determines serious or life-threatening resident care deficiencies exist at the limited private inpatient facility or that the facility fails to take the necessary corrective action, the Secretary may: (1) Revoke or place restrictions on the license; (2) Impose a civil money penalty of not more than $10,000 per instance or per day; (3) Impose a directed plan of correction; or (4) Impose appropriate operating conditions. B. When considering whether to impose a civil money penalty and the amount of the penalty, the Secretary shall consider the following factors: (1) The number, nature, and seriousness of the violations; (2) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; (4) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (5) Such other factors as justice may require. C. A person aggrieved by the action of the Secretary under §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. #### Regulation .20 Emergency Suspension. *COMAR 10.07.16.20* A. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action. B. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that form the basis for the emergency suspension; and (3) Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is immediately suspended, the licensee shall: (1) Immediately return the license to the Department; and (2) Stop providing services immediately. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. F. The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .22 of this chapter and issue a proposed decision. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. G. If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. #### Regulation .21 Revocation of License. *COMAR 10.07.16.21* A. The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested. B. The Secretary may revoke a license if the licensee: (1) Has been convicted of a felony that relates to Medicaid or Medicare or a crime involving moral turpitude; (2) Does not comply with the requirements of this chapter; or (3) Fails to comply with the standards for the operation of a limited private inpatient facility or comparable facility as set forth in the Standards for Behavioral Health Care. C. The Secretary shall notify the licensee in writing of the following: (1) The effective date of the revocation; (2) The reason for the revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the revocation; (4) That the licensee is entitled to a hearing if requested, and to be represented by counsel; (5) That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing; (6) That the revocation shall be stayed if a hearing is requested unless the license has been immediately suspended or the revocation is based upon the loss or denial of accreditation from the Joint Commission; and (7) That the licensee is required to surrender the license to the Department if the revocation is upheld. D. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .22 of this chapter. #### Regulation .22 Hearings. *COMAR 10.07.16.22* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-201 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35. #### Regulation .23 Licensure Standards Waiver. *COMAR 10.07.16.23* A. The Department may grant a limited private inpatient facility a waiver from the licensure requirements under Regulation .12 of this chapter with, or without, conditions. B. Application for Licensure Standards Waiver. (1) A facility shall submit a request for a waiver on a form developed by the Department. (2) The requestor shall provide in writing the: (a) Regulation from which a waiver is sought; (b) Reason the facility is unable to comply with the regulation; (c) Reason that compliance with the regulation will impose a substantial hardship; and (d) Reason that a waiver will not adversely affect residents. C. Evaluation of Application for Licensure Standards Waiver. In evaluating a waiver request, the Department shall review the statements in the application, and may: (1) Inspect the limited private inpatient facility; (2) Confer with the limited private inpatient facility director; or (3) Discuss the request with the residents or their representatives to determine whether the residents or their representatives believe a waiver is in the residents’ best interest. D. Grant or Denial of Licensure Standards Waiver. (1) The Department may grant a waiver request if the Department determines that: (a) Compliance with the regulation from which the waiver is sought cannot be accomplished without substantial hardship; and (b) A waiver will not adversely affect residents. (2) If the Department determines that the conditions of §D(1) of this regulation are not met, the Department shall deny the request for a waiver. The denial of a waiver may not be appealed. E. Written Decision. (1) The Department shall issue and mail to the applicant a written decision on a waiver request submitted under §B of this regulation within 45 days from receipt of the request and all appropriate supporting information. (2) If the Department grants the waiver, the written decision shall include: (a) The waiver’s duration; and (b) Any conditions imposed by the Department. F. If the limited private inpatient facility violates any condition of the waiver, or if it appears to the Secretary that the health or safety of residents residing in the limited private inpatient facility will be adversely affected by the continuation of the waiver, a waiver may be revoked. The revocation of a waiver may not be appealed. ### Chapter 17 — Limited Service Hospital **Authority:** Health-General Article, §§19-301, 19-307, 19-307.1, 19-308, 19-319, 19-320, and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.06 adopted as an emergency provision effective August 23, 1985 (12:19 Md. R. 1842); emergency status expired November 21, 1985; adopted permanently effective December 2, 1985 (12:24 Md. R. 2348) **Administrative History:** Chapter, Freestanding Emergency Facilities, repealed as an emergency provision effective July 1, 2000 (27:16 Md. R. 1519); repealed permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Chapter, Limited Service Hospital, Regulations .01—.10 adopted as an emergency provision effective July 1, 2000 (27:16 Md. R. 1519); adopted permanently effective October 30, 2000 (27:21 Md. R. 1975) **Administrative History:** Regulation .03A amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .04A amended effective March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Definitions. *COMAR 10.07.17.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advanced life support” means initial resuscitation or emergency care provided to a patient with a serious illness or injury. (2) “Department” means the Maryland Department of Health. (3) “Facility” means a limited service hospital. (4) “License” means a license issued by the Secretary to operate a limited service hospital in this State. (5) “Limited service hospital” means a health care facility that: (a) Is licensed as a hospital on or after January 1, 1999; (b) Changes the type or scope of health care services offered by eliminating the facility's capability to admit or retain patients for overnight hospitalization; and (c) Retains an emergency or urgent care center for the purpose of providing advanced life support. #### Regulation .02 License Required. *COMAR 10.07.17.02* A person may not convert to, operate, or continue the operation of an existing limited service hospital without first obtaining a license from the Secretary. A license is valid for 1 year from the date of issuance, unless revoked by the Secretary. #### Regulation .03 Application Procedure. *COMAR 10.07.17.03* A. A person desiring to convert an existing facility, or to change the classification of an existing hospital to a limited service hospital, shall file an application with the Secretary, on a written or electronic form provided by the Secretary. B. An application on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, association, or governmental unit or agency. The names of their board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if owned by other than the applicant. The names of persons holding 2 percent or more of the stock or assets of the limited service hospital shall be disclosed. C. Along with the application, the applicant shall provide: (1) A statement signed by the applicant that the facility will be open 24 hours a day, 7 days a week; (2) A plan describing the services to be provided by the facility, including but not limited to the following: (a) Types and scope of services, (b) A description of staff, including the number and types of health care professionals who will be on duty at all times, and (c) Qualifications, duties, and responsibilities of personnel; (3) A written description of the facility's quality assurance program which includes, at a minimum: (a) A description of how the facility will comply with Regulation .06A of this chapter, and (b) The manner in which information will be collected; (4) Policies and procedures, including but not limited to the following: (a) The transfer or referral of patients who require services that are not provided by the facility, (b) The administration of medicines unique to the needs of the patients, (c) Infection control procedures, (d) Development and implementation of a quality assurance program, (e) Pertinent safety practices, including the control of fire and mechanical hazards, and (f) Preventive maintenance for equipment in the facility; (5) Protocols for obtaining specialized services; (6) Protocols for emergency situations, including: (a) Procedures for transporting individuals to hospitals or other health care facilities, and (b) Plans to ensure that there will be sufficient nurses and other health professionals with appropriate training on duty to provide advanced life support; (7) A statement of the facility's role in the Emergency Medical Services System as approved by the Maryland Institute for Emergency Medical Services Systems; and (8) A statement that the facility's emergency services are available to all persons regardless of ability to pay. D. Fee. An application shall be accompanied by the nonrefundable license fee of $1,000. E. Issuance of a License. The Department shall issue a license to a facility that meets the requirements of this chapter. #### Regulation .04 License Renewal. *COMAR 10.07.17.04* A. The licensee shall file an application for license renewal on a written or electronic form provided by the Secretary at least 60 days before the current license expires. B. The licensee shall include with the application for license renewal: (1) Updated documents listed in Regulation .03C(2) — (8) of this chapter if any of the information has changed during the current licensure period; and (2) The nonrefundable license fee of $1,000. #### Regulation .05 Standards for Service. *COMAR 10.07.17.05* A. A facility shall comply with applicable federal, State, and local laws and regulations. B. Restriction of License—Nomenclature. A limited service hospital may not use in its title the words “emergency department”, “emergency center”, “emergency room”, or any other terminology in referring to the limited service hospital or any part of the facility that may convey to the public that the facility is prepared to provide the full range of emergency services that are normally provided by a hospital. C. Hours of Operation. The facility shall be open 24 hours a day, 7 days a week. D. Staff. (1) At least one physician who is credentialed in emergency medicine shall be at the facility at all times. (2) The facility shall have a sufficient number of registered nurses and other health professionals with appropriate training to provide advanced life support. E. Laboratory and Radiologic Services. The facility shall have basic x-ray and laboratory services available at all times and be staffed by at least: (1) One radiology technician; and (2) One laboratory technician. F. Pharmaceutical Services. (1) Pharmaceutical services shall be supervised by a pharmacist licensed to practice in this State. (2) The facility shall provide pharmaceutical services in accordance with accepted professional principles and appropriate federal, State, and local laws and regulations. G. Clinical Records. (1) The facility shall maintain clinical records for all patients in accordance with accepted professional standards and practices. (2) Clinical records shall contain: (a) Identification and summary, including, at least, the patient's name, Social Security number, marital status, age, sex, and home address; (b) Name, address, and telephone number of the personal physician, dentist, parent or next of kin, or authorized representative; (c) Evidence of assessment of the patient's needs, of establishment of an appropriate plan of initial and ongoing treatment, and of the care or services provided; (d) Consent forms when required; (e) Diagnostic and therapeutic orders; (f) Reports of medication administration, treatments, and clinical findings; and (g) Discharge summary including final diagnosis and prognosis. (3) Current clinical records and those of discharged patients shall be completed promptly. All clinical information pertaining to a patient shall be centralized in the patient's clinical record. (4) Clinical records shall be retained for a period of not less than 5 years from the date of discharge or, in the case of a minor, 3 years after the patient becomes of age or 5 years, whichever is longer. H. Equipment. (1) A facility shall have the equipment necessary to provide at least the following care: (a) Cardiac monitoring, defibrillation, and external pacing; (b) Medication administration; (c) Oxygen therapy; (d) Airway management including endotracheal intubation; (e) Respiratory ventilation; and (f) Intravenous and intraosseous access and fluid therapy. (2) All equipment at the facility shall be in good operating condition at all times. I. Infection Control. A facility shall: (1) Develop and implement policies and procedures on the use of standard precautions for infection control; and (2) Comply with the requirements of COMAR 10.06.01.07, except in an emergency life-threatening situation when it is not feasible or practical to comply with the infection control measures. #### Regulation .06 Quality Assurance. *COMAR 10.07.17.06* A. The facility shall plan and implement a quality assurance program which includes: (1) Monitoring and evaluation of the quality of patient care; (2) Identification, evaluation, and resolution of care problems; and (3) A peer review process. B. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly. C. Peer Review. The facility shall establish a peer review process that includes: (1) A mechanism to evaluate the clinical performance of each health care practitioner on a continuous basis, but not less than annually; (2) Procedures, approved by a supervising physician, to identify and minimize risks to the patient; and (3) Documentation of each health care practitioner's annual evaluation. D. Equipment Quality Control. (1) The facility shall develop and implement a quality control procedure to monitor the safety and performance of all biomedical equipment. (2) In developing its procedures, the facility shall consider: (a) FDA recommendations; and (b) The equipment manufacturer's recommendations. E. Quality Assurance Records. The facility shall document the following information for all quality assurance activities: (1) A description of identified problems; (2) Findings; (3) Conclusions; (4) Recommendations; (5) Actions taken; (6) Results; and (7) Follow-up. #### Regulation .07 Risk Management Program. *COMAR 10.07.17.07* A. A facility shall comply with the requirements of COMAR 10.07.01.25. #### Regulation .08 Utilization Review. *COMAR 10.07.17.08* A facility shall comply with the requirements of COMAR 10.07.01.13—.19. #### Regulation .09 Physician Credentialing. *COMAR 10.07.17.09* A facility shall comply with the requirements of COMAR 10.07.01.24. #### Regulation .10 Penalties. *COMAR 10.07.17.10* A. The Secretary shall deny a license to a person who has been convicted of a felony that relates to Medicaid or to a nursing home. B. The Secretary shall revoke the license of any licensee convicted of a felony that relates to Medicaid or to a nursing home. C. The Secretary may deny or revoke a license if the facility does not meet the requirements of: (1) Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (2) Any regulation adopted under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland. D. A person aggrieved by an action of the Secretary may request a hearing in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03. ### Chapter 18 — Comprehensive Rehabilitation Facilities **Authority:** Health-General Article, §19-1201 et seq., Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 adopted as an emergency provision effective July 1, 1986 (13:15 Md. R. 1727); adopted permanently December 1, 1986 (13:24 Md. R. 2558) **Administrative History:** Regulation .04B, E amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05A amended effective June 24, 1991 (18:12 Md. R. 1339); September 16, 2002 (29:18 Md. R. 1443) #### Regulation .01 Definitions. *COMAR 10.07.18.01* A. In this chapter, the following words have the meanings indicated. B. Terms Defined. (1) “Commission on Accreditation of Rehabilitation Facilities” means the private, nonprofit organization formed in 1966 which has established standards of quality for rehabilitation services, and which accredits those who provide the services. (2) “Comprehensive physical rehabilitation services” has the meaning stated in Health-General Article, §19-1201(b), Annotated Code of Maryland. (3) “Comprehensive rehabilitation facility” means any person who provides or holds itself out as providing comprehensive physical rehabilitation services on an out-patient basis. (4) “Specialized rehabilitation program” has the meaning stated in Health-General Article, §19-1201(e), Annotated Code of Maryland. #### Regulation .02 Scope. *COMAR 10.07.18.02* This chapter does not apply to a home health agency or special rehabilitation hospital. #### Regulation .03 Compliance Required. *COMAR 10.07.18.03* A comprehensive rehabilitation facility shall comply with the requirements of this chapter before the facility may provide: A. Comprehensive rehabilitation services; or B. A specialized rehabilitation program. #### Regulation .04 License Provisions. *COMAR 10.07.18.04* A. A comprehensive rehabilitation facility license is required before a person may provide or hold itself out as providing comprehensive physical rehabilitation services in the State. B. To obtain a comprehensive rehabilitation facility license, a person shall: (1) Submit an application on the written or electronic form provided by the Secretary; (2) Pay to the Secretary an application fee of $10; and (3) Meet any requirement imposed under Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. C. Applications on behalf of a corporation, association, or governmental unit or agency shall be made by two officers of the corporation, or governmental unit or agency, and names of their Board members shall be submitted. Ownership of property, real estate, and equipment shall be disclosed if it is other than the licensee's. The names of persons holding 2 percent or more of the stock or assets shall be disclosed. D. A comprehensive rehabilitation license expires on the first anniversary of its effective date, unless it is renewed for a 1-year term. E. An application for the renewal of the license shall be made on the written or electronic form provided by the Secretary at least 60 days before expiration of the issued license. F. Separate licenses are required for institutions maintained on separate premises, even though both institutions are operated under the same management. #### Regulation .05 Standards of Operation. *COMAR 10.07.18.05* A. A comprehensive rehabilitation facility: (1) Shall be accredited by the Commission on Accreditation of Rehabilitation Facilities; (2) May provide only those specialized rehabilitation programs that the facility has been accredited to provide by the Commission on Accreditation of Rehabilitation Facilities; (3) Shall meet the standards provided by the Commission on Accreditation of Rehabilitation Facilities as set forth in the 2002 Medical Rehabilitation Standards Manual (Commission on Accreditation of Rehabilitation Facilities, 4891 East Grant Road, Tucson, AZ 85712) which is incorporated by reference; (4) Shall meet any other requirements that may be imposed by law. B. Waiver of Accreditation. (1) To allow a comprehensive rehabilitation facility to achieve accreditation by the Commission on Accreditation of Rehabilitation Facilities as required under this regulation, the accreditation requirement shall be waived for any comprehensive rehabilitation facility that has submitted an appropriate application for accreditation. (2) The waiver under this section shall be effective for not more than 2 years from the later of: (a) July 1, 1986; or (b) The date on which the facility begins operations. C. The Secretary may inspect a comprehensive rehabilitation facility to assure that the facility meets the requirements of this chapter. #### Regulation .06 Records and Reports — Inspection. *COMAR 10.07.18.06* Licensees shall keep such records and make reports in the manner and form as the Secretary shall prescribe, and all these records shall be open to inspection by the Secretary. #### Regulation .07 Enforcement. *COMAR 10.07.18.07* The Secretary may enforce the provisions of this chapter by any method available at law, including any civil action or criminal prosecution. Civil actions include, but are not limited to, license revocations. ### Chapter 19 — Private Review Agents *Transferred to COMAR 31.10.21* **Administrative History:** Effective date: June 6, 1994 (21:11 Md. R. 951) **Administrative History:** Regulations .01—.06, .08—.10, and .12 amended, Regulation .07 repealed, Regulations .08—.12 recodified to .07—.11, and entire chapter recodified to new chapter COMAR 31.10.21 as an emergency provision effective January 1, 1999 (26:2 Md. R. 104); amended and recodified permanently effective March 22, 1999 (26:6 Md. R. 491) ### Chapter 20 — Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID) **Authority:** Health-General Article, §§19-318, 19-320, and 19-323, Annotated Code of Maryland **Administrative History:** Effective date: December 28, 1987 (14:26 Md. R. 2747) **Administrative History:** (COMAR 10.07.20 amended and transferred from COMAR 10.22.04 Public and Private Residential Care Facilities Serving the Mentally Retarded (ICF-MR)) **Administrative History:** Regulation .01B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .02 amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .03B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulation .04B, E amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .05A amended effective February 20, 1989 (16:3 Md. R. 342) **Administrative History:** Regulation .05E adopted effective December 17, 2007 (34:25 Md. R. 2210) #### Regulation .01 Scope. *COMAR 10.07.20.01* This chapter applies to any person, whether public or private, operating a facility that: A. Provides health-related services on a regular basis to individuals: (1) Who do not require hospital care; and (2) Whose mental or physical condition requires services that: (a) Are above the level of room and board; and (b) Can be made available only through institutional facilities; and B. Has as its primary purpose the provision of health rehabilitative services for individuals with an intellectual disability or related conditions. #### Regulation .02 Applicability of Health-General Article, Annotated Code of Maryland. *COMAR 10.07.20.02* An intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) shall be considered: A. A “related institution” under Health-General Article, §19-301, Annotated Code of Maryland, and shall be governed by the provisions of Title 19, Subtitle 3 of that article; and B. A provider of “services” under Health-General Article, §7-101, Annotated Code of Maryland, and shall be governed by the applicable provisions of Title 7 of that article including: (1) Subtitle 4: Provisions of Services; (2) Subtitle 5: State Residential Centers for Individuals With Mental Retardation if the facility is operated by the State; (3) Subtitle 8: Transfers; and (4) Subtitle 10: Rights of Individuals. #### Regulation .03 Definitions. *COMAR 10.07.20.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Facility” means an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) within the scope of this chapter. (3) “License” means a license issued by the Secretary to operate a facility. (4) “Secretary” means the Secretary of Health. #### Regulation .04 Licensing Procedure. *COMAR 10.07.20.04* A. A person shall be licensed by the Secretary before the person may operate a facility in the State. B. An applicant for a license shall: (1) Submit to the Secretary an application: (a) In the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary; and (b) Signed and verified by the applicant; and (2) Pay to the Secretary an application fee in the amount provided in COMAR 10.07.15. C. The Secretary shall issue a license to an applicant who meets the requirements of these regulations. D. A license authorizes the licensee to operate a facility while it is effective and is not transferable. E. Term and Renewal of License. (1) A license expires on the first anniversary of its effective date unless it is renewed for a 1-year term as provided in this section. (2) Before the license expires, the licensee may renew it for another 1-year term, if the licensee submits to the Secretary: (a) A renewal application in the form and manner prescribed by the Secretary on the written or electronic form provided by the Secretary; (b) Satisfactory evidence of compliance with any requirement of the regulations for license renewal; and (c) The license renewal fee provided in COMAR 10.07.15. F. The Secretary may: (1) Deny a license to any applicant; (2) Deny the renewal of a license to a licensee; or (3) Revoke a license of a licensee if the applicant or licensee does not meet the requirements of this chapter. #### Regulation .05 Standards of Operation. *COMAR 10.07.20.05* A. General. Whether or not a facility participates in Medicare or Medicaid, the facility shall meet the requirements set forth in 42 CFR § 483.400 et seq., which is incorporated by reference. B. Safety and Sanitation. The facility, its grounds, fixtures and equipment shall be: (1) Maintained in good repair, clean, and attractive; (2) Free of unnecessary accumulations of personal property or debris; and (3) Free of hazards, insects, and rodents. C. Infection Control. The administrator shall: (1) Establish policies and procedures to investigate, control, and prevent infections in the facility; and (2) Ensure that facility staff follow these policies and procedures. D. Personnel. (1) The administrator shall provide orientation and training for all staff and volunteers. (2) If the center provides care for individuals with Alzheimer's disease or related disorders: (a) The administrator shall provide annual in-service education on the care of individuals with dementia; and (b) Each employee shall complete an instructional unit on dementia as described in COMAR 10.07.02.40H before the later of: (i) 180 days from beginning of employment, or (ii) One year from the effective date of these regulations. (3) Employee Health Screening. A facility shall obtain certification that an employee or volunteer is free from tuberculosis in a communicable form as provided in Regulation .06 only if the employee or volunteer: (a) Will be involved in the direct care of tuberculosis patients; or (b) Is an immigrant from Africa, Asia, or Latin America. E. Emergency Management Plans. State residential centers shall develop an emergency plan for all types of emergencies and disasters that shall include: (1) Procedures that will be followed before, during, and after an emergency to address the following: (a) The evacuation, transportation, or 72-hour shelter-in-place of individuals and staff served; (b) Holding an annual practice drill coordinated with local emergency planners for sheltering-in-place or evacuating; (c) Preparing an after action report and improvement plan after drills that evaluates the plan and takes corrective actions; (d) Ensuring that individuals served and staff have identification with current health, contact, and other important information that is immediately accessible in the event of evacuation; (e) The role of the resident, family member, or legal representative in the event of evacuation; (f) Arranging for medical needs and other accommodations for individuals served and staff at alternative facilities or shelters; and (g) Establishing a communication protocol among all appropriate parties that includes redundant communication means; (2) The notification to families, staff, and respective DDA regional office regarding the action that will be taken concerning the safety and well-being of the individuals served; (3) The staff coverage, organization, and assignment of responsibilities that includes: (a) Planning staff coverage needs for ongoing shelter-in-place or evacuations; (b) Identifying staff members available to report for work or remain during extended periods; and (c) Establishing staff notification and recall contingency plans and procedures; (4) The continuity of operations, including, but not limited to, redundant communications systems, preservation of records and electronic data, the procurement of essential goods, equipment, and services, plans to secure vacated facilities, and the relocation to alternate facilities; (5) Procedures to: (a) Backup and electronically store off-site, appropriate records and data of consumers and staff and facility documents, for access under emergency conditions; and (b) Ensure access to an electronic copy of the emergency plans when requested by local, State, or federal emergency management organizations; (6) Provisions to ensure that the facility's emergency and disaster plans are shared with local emergency management organizations for the purpose of coordinating local emergency planning; (7) An executive summary of the evacuation procedures that shall be provided to the family member of a resident on request; and (8) A summary statement of the facility's community surge capacity abilities. #### Regulation .06 Tuberculosis Screening. *COMAR 10.07.20.06* A. An employee or volunteer may be certified as required in Regulation .05D(3) in one of the following four ways: (1) If the individual has documentation of a negative tuberculin test by the Mantoux method within the past 24 months and has, by history, no contact with a person with tuberculosis in a communicable form subsequent to this documentation or no symptoms consistent with tuberculosis, the individual shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form. Further skin testing may not be necessary except for epidemiologic diagnostic purposes which may be required by the local health officer or the Department. (2) If the individual does not have documentation of a negative tuberculin test by the Mantoux method within the past 24 months and does not have a history of having had a positive tuberculin test by the Mantoux method, the following procedure shall be done: (a) Five Tuberculin Units (TU) of Purified Protein Derivative (PPD) shall be administered intradermally and the results read 48—72 hours subsequent to the administration of the test; (b) An individual with induration of 5—9 mm and no history of contact with a person with tuberculosis in a communicable form or an individual with induration of 0—4 mm shall be considered to be a negative tuberculin reactor and to be free from tuberculosis in a communicable form; (c) An individual with induration of 5—9 mm and a history of contact with a person with tuberculosis in a communicable form or an individual with induration of 10 mm or more shall be considered to be a positive tuberculin reactor and shall be handled as described in §A(3)(a),(b), and (c), of this regulation. (3) If the individual is a positive tuberculin reactor as defined in §A(2)(c), of this regulation, or if the individual has a history of a positive tuberculin test by the Mantoux method without documentation of having received an adequate course of therapy, as defined by the local health officer, for tuberculosis disease or received adequate prophylaxis, as defined by the local health officer, for tuberculosis infection, the following procedure shall be done: (a) If the individual does not have documentation of a negative chest X-ray within the past 12 months, the individual shall be evaluated by a chest X-ray. If the chest X-ray is negative, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray in 12 months, unless isoniazid therapy is instituted, in which case the second chest X-ray is unnecessary. (b) If the individual has documentation of a negative chest X-ray within the past 12 months, the individual shall be considered to be free from tuberculosis in a communicable form and shall have a repeat chest X-ray 12 months after the most recent documented chest X-ray unless isoniazid therapy has been instituted, in which case the second chest X-ray is unnecessary. (c) If the individual has had two successive negative chest X-rays 12 months apart, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. (4) If the individual has documentation of an adequate course of therapy, approved by the local health officer, for tuberculosis disease or adequate prophylaxis, approved by the local health officer, for tuberculosis infection, no further chest X-rays are necessary and the individual shall be considered to be free from tuberculosis in a communicable form unless the individual has symptoms consistent with tuberculosis. B. The facility shall instruct each employee and volunteer in the signs and symptoms of active tuberculosis and advise the individual to seek immediate medical care should the individual detect these signs or symptoms. C. If the individual meets any of the following criteria, the facility shall have written policies and procedures, acceptable to the Department, for the evaluation, management, and surveillance of this individual: (1) A history of tuberculosis or tuberculosis infection without documentation of adequate treatment as defined and determined by the local health officer; (2) Is currently being treated for tuberculosis disease or tuberculosis infection; (3) Has chest X-rays consistent with tuberculosis without documentation of adequate treatment as defined and determined by the local health officer; or (4) Symptoms consistent with tuberculosis or a history of contact with a person with tuberculosis in a communicable form within the past 12 months. D. The facility shall maintain the following records: (1) Results of Mantoux tests, recorded in millimeters of induration with dates of administration, dates of reading and results of tests; (2) Results of X-rays required in §A(3)(a),(b), and (c), of this regulation; and (3) Documentation of any Mantoux test, chest X-ray, chemotherapy, and chemoprophylaxis which is the basis for the certification that the individual is free from tuberculosis in a communicable form. #### Regulation .07 Inspections. *COMAR 10.07.20.07* A. The Department shall inspect each facility at least annually to determine compliance with these regulations. B. A licensed facility and any facility applying for a license shall be open to inspection by the Department at all times. ### Chapter 21 — Hospice Care Programs **Authority:** Health-General Article, §§19-903 and 19-907, Annotated Code of Maryland **Administrative History:** Effective date: October 2, 1989 (16:19 Md. R. 2104) **Administrative History:** Regulations .01—.16 repealed and new Regulations .01—.28 adopted effective August 10, 1998 (25:16 Md. R. 1274) **Administrative History:** Regulation .04B amended effective August 29, 2016 (43:17 Md. R. 953); March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Scope and Purpose. *COMAR 10.07.21.01* This chapter applies to any general or limited hospice care program as defined in Health-General Article, §19-901, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.07.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Attending physician” means the physician having the most significant role in the determination and delivery of the hospice patient's medical care. (2) Bereavement Services. (a) “Bereavement services” means counseling services provided to the patient's family after the patient's death. (b) “Bereavement services” includes: (i) Personal contacts with the family by hospice employees or volunteers; (ii) Support groups; and (iii) Referrals to other service providers. (3) “Department” means the Maryland Department of Health. (4) “Family” means a group of two or more individuals related by legal status or affection who consider themselves a family. (5) “General hospice care program” means a coordinated, interdisciplinary program of hospice care services designed to meet the special physical, psychological, spiritual, and social needs of dying individuals and their families, by providing palliative and supportive medical, nursing, and other health-related services during illness and bereavement through home or inpatient care. (6) “Home-based hospice services” means hospice care services provided to a patient in the patient's permanent or temporary residence. (7) Hospice Care Program. (a) “Hospice care program” means a coordinated, interdisciplinary program of hospice care services. (b) “Hospice care program” includes a general or limited hospice care program. (8) “Inpatient care services” means services provided by a general hospice care program for the purpose of pain control, symptom management, or respite. (9) “License” means a license issued by the Secretary to operate a general or limited hospice care program. (10) “Limited hospice care program” means a coordinated, interdisciplinary program of hospice care services designed to meet the special physical, psychological, spiritual, and social needs of dying individuals and their families, by providing palliative and supportive nonskilled services during illness and bereavement through a home-based hospice care program. (11) “Physician” means an individual who is licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland. (12) “Representative” means an individual with legal authority to make health care decisions on behalf of the patient as set forth in Regulation .20 of this chapter. (13) “Secretary” means the Secretary of Health. (14) “Skilled services” means services that may be provided by an individual licensed under the Health Occupations Article, Annotated Code of Maryland. (15) “Social worker” means an individual licensed to practice in this State under Health Occupations Article, Title 19, Annotated Code of Maryland. #### Regulation .03 License Required. *COMAR 10.07.21.03* A. A person may not operate or represent itself as operating a hospice care program in this State, without first obtaining a license from the Secretary. B. Section A of this regulation applies to a home health agency, hospital, related institution, or other licensed facility that operates a hospice care program that is distinct from the other services that it is authorized to provide. C. Types of Licenses. The Secretary shall require a hospice care program to be licensed as a: (1) General hospice care program if the hospice care program provides, directly or by contract, home-based or inpatient care involving medical, nursing, or other skilled health services; or (2) Limited hospice care program if the program provides, directly or by contract, nonskilled hospice services in a home-based setting. D. A limited hospice care program shall refer patients in need of skilled services to a general hospice care program, or arrange for this care to be provided by an authorized health care provider. E. Duration of License. A license expires on the third anniversary of its effective date unless it is: (1) Renewed as provided in Regulation .04 of this chapter; or (2) Revoked as provided in Regulation .27 of this chapter. F. A license to operate a hospice care program is not transferable. #### Regulation .04 Application Procedure. *COMAR 10.07.21.04* A. Before a person may apply for a license to operate a general hospice care program, the person shall obtain a certificate of need from the Maryland Health Resources Planning Commission under Health-General Article, Title 19, Annotated Code of Maryland. B. The applicant shall submit an application for an initial license or renewal of a license on a written or electronic form provided by the Secretary. C. The applicant shall provide the following information with the application as applicable: (1) If the applicant is an individual and is sole owner of the hospice care program, the name and address of the applicant; (2) If the applicant proposes to operate a facility providing inpatient hospice care services and someone other than the applicant owns the building or real property, or both, the name and address of the owner or owners; (3) If the applicant is a partnership or limited partnership: (a) The legal name of the partnership or limited partnership; (b) Any trade name used by the partnership or limited partnership; and (c) The name and address of each partner; (4) If the applicant is a corporation: (a) The name of the corporation; (b) The date of incorporation; (c) The state of incorporation; (d) The name and address of each director; (e) If the corporation is incorporated outside of the State, the name and address of the resident agent of the corporation; (f) The name and address of each officer; and (g) The name and address of any stockholder owning more than 5 percent of the stock of a corporate applicant; (5) A statement that the applicant meets the requirements of Health-General Article, Title 19, Annotated Code of Maryland, and this chapter; (6) The name of the individual who is to be the medical director of the hospice care program; (7) The location and postal address of: (a) The principal office of the proposed hospice care program; (b) Any other office of the proposed hospice care program; (c) Any facility providing inpatient hospice services to be operated by the hospice care program; and (d) Any location where home-based hospice services are being provided in a residence owned or operated by the hospice; and (8) A copy of the certificate of need determination from the Maryland Health Resources Planning Commission as required under §A of this regulation. D. The Secretary: (1) Shall deny or revoke a license if the applicant or licensee has been convicted of a felony involving Medicaid fraud or other activity involving a nursing home, or its residents; or (2) May deny or revoke a license of the applicant or licensee who does not otherwise meet the requirements of this chapter. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .05 Inspection by the Department. *COMAR 10.07.21.05* A. A licensee, or a program seeking licensure under this chapter, shall be open at all times to inspection by the Department, and any agency designated by the Secretary, to conduct an inspection. B. The Department may: (1) Periodically inspect a hospice care program for compliance with this chapter; and (2) Conduct complaint investigations involving alleged licensure violations. C. Noncompliance. (1) If the Secretary determines that a hospice care program fails to meet any provision of this chapter, the Secretary shall: (a) Advise the hospice care program of the exact nature of the violation; and (b) Require that the hospice care program specify what corrective action it is taking and monitor the hospice care program to ensure that it takes corrective action. (2) This section does not preclude the Secretary from imposing any of the sanctions set forth in Regulation .27 of this chapter. #### Regulation .06 Administration. *COMAR 10.07.21.06* A. Responsibility of Licensee. A licensee shall ensure that the operation of the hospice care program complies with Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland, and this chapter. B. Governing Body. (1) A licensee shall have a governing body for the hospice care program. The governing body shall: (a) Determine the hospice care program's mission and purpose; (b) Conduct a periodic community needs assessment; (c) Provide outreach programs appropriate to the needs of the communities it serves, including making information about hospice care services readily available and providing appropriate educational activities to the communities it serves; (d) Make efforts to secure access to hospice care services for the underserved; (e) Adopt administrative and clinical policies and procedures, and review them annually; (f) Monitor the hospice's program and establish a process to evaluate the quality of services it is providing; (g) Have fiscal and fiduciary responsibility for the hospice care program including the review and approval of its budget; (h) Ensure compliance with all legal requirements; (i) Adopt bylaws which: (i) Specify the role and responsibility of the governing body; and (ii) Define the hospice care program's relationship to any other governing body; and (j) Develop and implement a written conflict of interest policy which includes guidelines for the resolution of any existing or apparent conflict of interest. (2) All members of the governing body shall participate in an orientation program and continuing education to enable the members to fulfill their responsibilities to the hospice care program. C. Administrator. (1) The governing body or the licensee shall: (a) Identify an administrator who has full responsibility for the day-to-day operations of the hospice care program; and (b) Evaluate the administrator's performance on at least an annual basis. (2) In the absence of the administrator, the program shall remain under the continuous supervision of a designated individual with appropriate experience and training. #### Regulation .07 Policies and Procedures. *COMAR 10.07.21.07* The hospice care program shall adopt and implement written policies and procedures for: A. The use of advance directives; B. Identifying, reviewing, and discussing ethical dilemmas which arise in the care of patients and family; C. The use of specific treatment modalities in different hospice care settings, that is, palliative chemotherapy or radiation; D. The administration of medications, including who is qualified to administer medications; E. The management of treatment-related complications; F. The use of investigational drugs and implementation of research protocols; G. The initiation of resuscitation; H. Attending to remains at the time of death; I. The disposal of controlled drugs after death; J. The provision of inpatient hospice care including: (1) Privacy needs, including space for families to gather; (2) 24-hour visitation and overnight stays; and (3) Religious and spiritual worship; K. Admission, transfer, and discharge, including criteria to be used for each; and L. Obtaining informed consent. #### Regulation .08 Personnel. *COMAR 10.07.21.08* A. The hospice care program shall maintain sufficient health care professionals and volunteers to meet patient care needs. B. The hospice care program shall identify an interdisciplinary care team with responsibility for ensuring continuous assessment of the patient's and family's needs and implementation of an integrated plan of care. The hospice care program shall ensure that: (1) A qualified health care professional coordinates the activities of the interdisciplinary care team; (2) The number of individuals who perform interdisciplinary team services is consistent with the needs of patients and their families and the type of services provided by the hospice care program; and (3) Each interdisciplinary care team consists of at least: (a) The patient's attending physician; (b) A physician with training in palliative care; (c) A registered nurse with demonstrated experience in pain and symptom management and the performance of physical assessments; (d) A master's degree-prepared social worker with clinical experience in counseling and casework for the terminally ill; (e) A volunteer, or volunteers, supervised by an individual with management experience in a hospice care program; and (f) A spiritual care counselor or counselors with education and experience in pastoral counseling. C. An interdisciplinary care team may include additional specialized team members needed to meet specific needs of patients as outlined in the patient's plan of care. Specialized team members may include allied therapists, art and music therapists, registered dietitians or licensed nutritionists, pharmacists, or nursing assistants. D. Specialized team members may be employees, volunteers, or contractual staff. E. Personnel Records. For all employees, volunteers, and contractual staff, the administrator shall ensure that there is: (1) An accurate, complete, and current personnel record that includes: (a) Verification of required licenses or certification; (b) A signed conflict of interest statement; (c) Written performance reviews; (d) Documentation of all required training; and (2) A job description for each position. F. Outside Agreements. If a hospice care program utilizes the services of an outside entity to provide certain hospice services, the hospice care program shall enter into a written agreement with that entity which includes at a minimum: (1) The service or services to be provided; (2) The roles, rights, and responsibilities of the contracting entity; (3) The roles, rights, and responsibilities of the hospice care program; and (4) A plan to ensure that any individual providing services under this section shall have at least comparable training to that required by this regulation. G. Orientation and Training. (1) The hospice care program shall ensure that all licensed staff receive orientation and training, which includes at a minimum: (a) The purpose and philosophy of hospice care; (b) The skills necessary to provide for the physical care of the patient; (c) The skills necessary to provide for the psychosocial and spiritual needs of the patient and family; and (d) The need and importance of maintaining professional boundaries with the patient and the patient's family. (2) The hospice care program shall have written criteria and a clear process for recruiting, selecting, and supervising volunteers, ensuring that: (a) Any volunteer who provides direct patient care receives appropriate orientation and at least 16 hours of training which includes, at a minimum: (i) The purpose and philosophy of hospice care; (ii) The role of the volunteer in hospice; (iii) Concepts of death and dying; (iv) Communication skills; (v) Care and comfort measures; (vi) The physical, psychosocial, and spiritual issues related to death and dying; (vii) The concept of the hospice family; (viii) Patient rights; (ix) Confidentiality; (x) Bereavement; (xi) Infection control; (xii) Safety; and (xiii) Stress management; and (b) A volunteer, other than those specified in §G(2)(a) of this regulation, receives appropriate orientation regarding the volunteer's role in the hospice care program. (3) Training shall be specifically tailored to ensure that staff is capable of providing care to meet the individual needs of patients. (4) The hospice care program shall provide continuing inservice education for all employees and volunteers providing direct patient services at least: (a) Once a year for volunteers; and (b) Four times a year for employees. #### Regulation .09 Quality Assurance. *COMAR 10.07.21.09* A. The governing body shall ensure that the hospice care program conducts ongoing quality assurance and utilization review. B. Quality Assurance Program. The governing body shall assure that the hospice care program develops and implements a quality assurance and improvement program to assess and improve the quality of services being provided by the program. C. The quality assurance and improvement program shall: (1) Focus on: (a) The needs, expectations, and satisfaction of patients and their families; and (b) All services provided by the hospice care program; (2) Have outcomes and results that are measurable and which may be incorporated into systemic changes in the program's operation; (3) Require the systematic collection, review, and evaluation of information and data and the analysis of trends identified through the quality assurance process; (4) Require that regular reports are prepared and reviewed by the governing body and appropriate personnel; (5) Provide for prompt and appropriate response to incidents when the patient's health and safety is at risk; and (6) Include proactive strategies to improve the quality of services. D. The hospice care program shall: (1) Establish goals and standards to measure the quality of the services being delivered and define how these standards are measured; (2) Maintain records to demonstrate the effectiveness of its quality assurance activities; (3) Implement changes based upon results of the evaluated data; for example, when problems are identified in the provision of services, the hospice care program shall document corrective actions taken, including ongoing monitoring, revisions of policies and procedures, and educational interventions; (4) Identify the individual responsible for performing the quality assurance functions as set forth in this regulation; and (5) Review the quality assurance and improvement program at least annually and make revisions as necessary. E. The hospice care program shall be held accountable by the governing body for accomplishing the goals and standards that are established as part of the quality assurance and improvement system. F. Utilization Review. (1) The hospice care program shall have a written plan for monitoring the allocation and utilization of patient and family services in order to identify and resolve concerns relating to the allocation and utilization of these services. The plan shall include: (a) Goals and objectives for utilization review; (b) Use of objective written criteria or treatment protocols to guide decisions about utilization of services; (c) The analysis of the need for services; (d) Time frames for review; (e) Methods for identifying utilization review concerns and mechanisms for resolving problems; and (f) A confidentiality policy consistent with legal and regulatory requirements. (2) The hospice care program shall review the utilization review plan at least annually and make revisions as necessary. (3) The plan shall include a monitoring protocol to address the following utilization concerns: (a) The appropriateness of the services being provided, including the level of intensity; (b) Patient admissions, including delays in the admission process; and (c) Delays in the provision of services and specific treatment modalities. (4) When the hospice care program identifies utilization problems, the hospice care program shall document corrective actions taken, including ongoing monitoring and educational interventions, as well as revisions to policies and procedures, and changes in the provision of services. (5) Reports to the Secretary. (a) Within 90 days after the close of a hospice care program's fiscal year, the hospice care program shall submit to the Department a report of the services it provided during the last fiscal year. (b) The report shall include the: (i) Types of services the hospice care program provided; (ii) Number of patients provided each type of service; (iii) Number of family members provided each type of service; and (iv) Changes in the number of patients or family members provided services from the previous year. #### Regulation .10 The Interdisciplinary Plan of Care. *COMAR 10.07.21.10* A. The interdisciplinary team shall develop a written plan of care for each patient and family. The plan of care shall reflect current standards of practice. The hospice care program shall document the attending physician's participation in the development, revision, and overall approval of the plan of care. B. The interdisciplinary plan of care shall reflect continuing communication between the attending physician and other members of the interdisciplinary care team. The interdisciplinary plan of care shall be reviewed, and revised if necessary, at least: (1) Every 14 days after admission for home-based hospice services; and (2) Every 7 days after admission for inpatient hospice services. C. The interdisciplinary plan of care shall recognize the patient's and family's psychological, social, religious, and cultural values. D. The interdisciplinary plan of care shall reflect efforts that the hospice care program staff and volunteers have made to: (1) Maximize patient independence; (2) Deliver services at the convenience of the patient, family, and caregiver; (3) Arrange respite services for caregivers; (4) Bridge gaps in the patient's care giving network; and (5) Adapt the home environment to meet the patient's physical needs. E. The interdisciplinary plan of care shall be based on the initial assessments conducted by interdisciplinary care team members. F. The hospice care program shall encourage the patient and family to participate in developing and implementing the interdisciplinary plan of care. G. Contents. The interdisciplinary plan of care shall include, at a minimum: (1) Identification of patient and family problems and needs; (2) Identification of realistic and achievable goals, objectives, and outcomes; (3) The frequency and mix of services, including bereavement needs; (4) The level of care to be provided; (5) Prescribed medication and treatments; and (6) Required medical equipment. H. Bereavement Plan. (1) The hospice care program shall initiate a written plan of bereavement intervention at the time of admission to the hospice which shall be incorporated into the patient's plan of care. (2) The bereavement plan shall be based on an assessment of the needs of the family and shall recognize the family's social, religious, and cultural values. (3) At a minimum, the bereavement plan shall include the: (a) Scope and frequency of bereavement services; and (b) Family's acceptance of bereavement services. #### Regulation .11 Continuity of Care. *COMAR 10.07.21.11* A. The hospice care program shall coordinate care to ensure continuity of care for the patient and family. B. Any changes in service delivery are to be based on an assessment of the patient's and family's needs and desires for hospice services and a hospice care program's transfer and discharge criteria. C. The hospice care program shall: (1) Provide case management for the patient and family; (2) Maintain an accurate, complete, and documented record of services and activities provided to the patient and family; (3) Collaborate with other organizations and individuals providing care to the patient and family to ensure coordination of services; (4) Provide on-call medical and nursing services in response to patient and family needs; (5) Ensure the safety of staff and inform the patient and family of any personnel, service, or access limitations; and (6) Have reporting mechanisms to keep all staff informed and updated about patient care changes to ensure continuity and coordination of care among interdisciplinary team members. #### Regulation .12 Transfer or Discharge. *COMAR 10.07.21.12* A. If the hospice care program does not provide inpatient hospice services directly, the hospice care program shall have a written transfer agreement with a hospice care program which provides those services. B. The hospice care program shall provide adequate and appropriate information about the patient and family at the time of transfer or discharge. C. When a patient and family transfers from one hospice care program to another or from home-based service to inpatient service, or vice versa, the current care provider shall provide a written summary of: (1) The services being provided; (2) The specific medical, psychosocial, spiritual, or other problems that require intervention or follow-up; and (3) Any scheduled follow-up by a current interdisciplinary care team member. D. The hospice care program shall document the specific reasons for transferring or discharging a patient from its program. These reasons may include: (1) The patient moves from the service area; (2) There is a change in terminal status; (3) The patient and family are unwilling to comply with the interdisciplinary plan of care or consistently act in a way which compromises the standards of care; (4) Issues of patient safety cannot be resolved; (5) Issues of staff safety cannot be resolved; or (6) Patient and family desire for discharge. E. The hospice care program shall prepare a written discharge summary which shall be provided to the patient or the patient's family before the patient's discharge. F. Before discharge, the hospice care program shall assess the patient's and family's continuing care needs and make referrals to appropriate services. #### Regulation .13 Physician Services. *COMAR 10.07.21.13* A. Medical Director. The hospice care program shall have a medical director who shall be: (1) A physician licensed to practice medicine in this State; and (2) Knowledgeable about the psychosocial and medical aspects of hospice care. B. Medical Director Duties. The medical director is responsible for: (1) Reviewing, coordinating, and managing the clinical and medical care for all patients in the hospice care program; (2) Consulting with attending physicians regarding pain and symptom control; (3) Reviewing patient eligibility for hospice services; (4) Acting as the medical resource for the interdisciplinary team; (5) Acting as the liaison to physicians in the community; and (6) Designating a physician to contact in case the medical director is unavailable. C. Attending Physician. An attending physician shall provide initial and ongoing medical services to the patient and participate in the development of the interdisciplinary plan of care. D. Attending Physician Duties. At a minimum, the attending physician shall provide the following information before the patient is admitted to the hospice care program: (1) Admitting diagnosis and prognosis; (2) Current medical findings; (3) Dietary restrictions; (4) Medication and treatment orders, including instructions for symptom management; and (5) Information concerning the medical management of patient conditions unrelated to the terminal illness. E. The hospice care program shall ensure that the attending physician designates another physician to contact in case the attending physician is unavailable. #### Regulation .14 Nursing Services. *COMAR 10.07.21.14* A. Nursing services shall be provided by licensed or certified personnel, trained or experienced in hospice care and supervised by a registered nurse with training or experience in hospice nursing. All nursing services shall be provided in accordance with the requirements of Health Occupations Article, Title 8, Annotated Code of Maryland. B. The hospice care program shall provide nurse staffing levels based on: (1) An assessment of patient and family care needs; (2) The experience level of the nursing staff available to provide services; and (3) Available assistance from support service staff. C. The hospice care program shall provide nursing services in accordance with each patient's interdisciplinary plan of care. D. Registered Nurse. A registered nurse shall: (1) Conduct the initial assessment of the patient; (2) Regularly reevaluate the patient's nursing needs; (3) Initiate the plan of care and necessary revisions; (4) Prepare clinical and progress notes, coordinate services, and inform the physician and other personnel of changes in the patient's condition and needs; (5) Inform the patient and family in regard to the patient's nursing needs; and (6) Supervise other nursing personnel. E. The initial assessment or any reevaluation of the patient's care needs may not be conducted by a licensed practical nurse or nursing assistant. Licensed practical nurses and nursing assistants shall provide all services in accordance with the patient's interdisciplinary plan of care. #### Regulation .15 Ancillary Services. *COMAR 10.07.21.15* A. The hospice care program shall have a written plan for the provision of pharmacy, laboratory, radiology, chemotherapy, and other ancillary services. When the service is provided by an organization other than the hospice care program, the hospice care program shall enter into a written agreement with the provider of ancillary services which specifies the services being provided and the procedures for accessing those services. B. The hospice care program shall ensure that ancillary services are provided in accordance with federal and State laws and regulations. C. Pharmacy Services. (1) The hospice care program shall employ or contract with a licensed pharmacist to: (a) Supervise all pharmacy services; (b) Serve as a consultant to the interdisciplinary care team; and (c) Ensure that all drugs and biologicals are prescribed, dispensed, administered, stored, and disposed of in accordance with applicable laws and regulations. (2) The hospice care program shall have a system to obtain and provide drugs on an emergency basis, 24 hours per day, 7 days a week. (3) The hospice care program shall maintain a drug profile for each patient and conduct periodic drug reviews and monitoring of each patient. (4) The hospice care program shall ensure that the interdisciplinary care team and the patient and the patient's family are made aware of each medication prescribed for the patient and are given any instructions concerning the administration of prescribed medications. #### Regulation .16 Counseling Services. *COMAR 10.07.21.16* A. Counseling Services. The hospice care program shall provide counseling services which address the needs of patients and families. The hospice care program shall provide counseling services as set forth in §§B—E of this regulation. B. Social Work Services. Social work services are to be based on an initial and continuing assessment of patient and family psychosocial needs. Each assessment shall be conducted by a social worker. Services shall be provided in accordance with each patient's interdisciplinary plan of care with the goal of assisting the patient and family in adjusting to the psychosocial aspects of terminal illness. C. Spiritual Services. The hospice care program shall provide spiritual services that are based on an initial, ongoing assessment of the spiritual needs of the patient and family. Spiritual services are to be consistent with patient and family beliefs and desires. These services shall be provided by a member of the interdisciplinary care team or by local clergy or spiritual counselors. D. Nutritional Counseling. The hospice care program shall provide nutritional counseling to the patient and family. This counseling shall be provided by either a registered nurse, registered dietitian, or licensed nutritionist as specified in the interdisciplinary plan of care. E. Bereavement services shall be provided as set forth in Regulation .10H of this chapter. #### Regulation .17 Emergency Services. *COMAR 10.07.21.17* A. The hospice care program shall ensure that emergency services are available 24 hours per day, 7 days a week. B. Emergency services are to include, at a minimum: (1) Registered nurse and physician services; (2) Palliative medications; and (3) Other services, equipment, and supplies necessary to meet the patient's immediate needs as directed by the patient's plan of care. #### Regulation .18 Volunteer Services. *COMAR 10.07.21.18* A. The hospice care program's volunteer services shall play a vital role in enhancing the quality of care delivered to the patient and family by encouraging community participation in the overall hospice care program. B. Volunteers may assist with patient care and administrative services consistent with the hospice care program's policies and in accordance with the requirements of this regulation. C. Volunteers shall document their activities in the clinical record. D. Volunteers shall comply with personnel policies and procedures. #### Regulation .19 Medical Records. *COMAR 10.07.21.19* A. The hospice care program shall establish and maintain a clinical record for each patient in accordance with accepted principles of practice for maintaining medical records. The record is to be complete, accurately documented, readily accessible, and systematically organized to facilitate retrieval of information. B. The hospice care program shall: (1) Document clinical and progress notes in a patient's medical record within 14 days of a visit or provision of services; (2) Obtain the attending physician's signature on an order within 30 days of receiving a verbal order; and (3) Close a medical record within 30 days of a patient's discharge. C. Access to or release of a patient's medical record by the hospice care program is permitted only with the consent of the patient or the patient's representative, or as required by law. D. If services are not provided directly by the hospice care program, the hospice care program shall obtain a copy of the applicable medical record or written summary of services provided and maintain it in the hospice care program's medical record. #### Regulation .20 Patient's Representative. *COMAR 10.07.21.20* A. A hospice care program shall recognize the authority of: (1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland; (2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland; (3) An advance directive established in compliance with Health-General Article, §5-602, Annotated Code of Maryland; (4) A surrogate decision maker with authority under Health-General Article, §5-605, Annotated Code of Maryland; (5) A power of attorney that meets the requirements of Estates and Trusts Article, §13-601, Annotated Code of Maryland; (6) A representative payee or other similar fiduciary; or (7) Any other person, if that person was designated by a patient who was competent at the time of designation, and the patient or representative has provided the hospice care program with documentation of the designation. B. The hospice care program may not recognize the authority of the patient's representative if the representative attempts to exceed the authority: (1) Stated in the instrument that grants the representative authority; or (2) Established by State law. C. The hospice care program shall document in the patient's record the name of the representative, including a copy, when applicable, of the designation. #### Regulation .21 Patient's Rights. *COMAR 10.07.21.21* A. The hospice care program shall provide the patient or representative with a written notice of the patient's rights in advance of furnishing care. Documentation verifying receipt of and understanding of this information shall be included as part of the patient's record. B. The patient has the right to: (1) Be treated with consideration and respect for individual dignity; (2) Confidentiality in all aspects of service or treatment; (3) Privacy; (4) Be free from physical or mental abuse; (5) Participate in the planning of the patient's hospice care; (6) Formulate advance directives as provided under State law; (7) Have all personal property treated with respect; (8) Refuse care and services, including continued participation in the hospice care program; (9) Be informed of short-term inpatient care options available for pain control, management, and respite; (10) Be informed of the hospice care program's discharge policy; (11) Make complaints or grievances to the hospice care program, government agencies, or other persons without threat or fear of retaliation; and (12) Be informed orally and in writing, before care is initiated, of the extent to which payment may be expected from the patient, third-party payers, and any other source of funding known to the hospice care program. C. The hospice care program shall ensure that all employees and volunteers respect the rights of a patient. #### Regulation .22 Complaint Procedure. *COMAR 10.07.21.22* A. A hospice care program shall establish a procedure under which a patient or family member may make a complaint to a representative of the hospice care program. B. The hospice care program shall investigate and seek to resolve the complaint. C. The hospice care program shall maintain documentation which reflects findings of the investigation and efforts to resolve the complaint. D. The hospice care program shall inform each patient and family of: (1) Its complaint procedure; and (2) The address and telephone number of the Department's Licensing and Certification Administration. E. The Department may conduct investigations of complaints involving alleged violations of this chapter. #### Regulation .23 Infection Control. *COMAR 10.07.21.23* A. The hospice care program shall have an infection control program in all care settings. B. There is to be a written plan for identifying, preventing, and controlling the spread of infection, which includes: (1) Identifying an individual responsible for implementing and monitoring the infection control program; (2) Establishing a system for periodic review and update of infection control policies and procedures governing at a minimum: (a) Personal hygiene; (b) Aseptic and isolation techniques; (c) Supplies, medication, and food storage; and (d) Waste disposal; (3) Reviewing patient and family caregiver practices to identify potential exposure to infection; and (4) Ensuring that the infection control program is monitored, reviewed, and evaluated regularly at specified intervals. #### Regulation .24 Safety and Emergency Preparedness. *COMAR 10.07.21.24* A. The hospice care program shall have a safety and emergency preparedness program that includes, at a minimum: (1) A plan for reporting, monitoring, and following up on all accidents, injuries, and safety hazards; (2) Education for patient and family caregivers, employees, and volunteers in the safe use of medical equipment; (3) Evidence that equipment maintenance and safety requirements have been met; and (4) A safe and sanitary system for identifying, handling, and disposing of special medical wastes that meets the requirements of COMAR 10.06.06. B. The hospice care program shall ensure that the emergency preparedness program provides appropriate continuous support and care to patients and families and other caregivers during natural or man-made disasters. C. The hospice care program shall monitor, review, and evaluate the safety and emergency preparedness program at regularly specified intervals. #### Regulation .25 Home-Based Hospice Care Provided in a Licensed Health Care Facility. *COMAR 10.07.21.25* A. Professional Management. (1) When a hospice care program delivers hospice care to a resident of a licensed health care facility, the hospice care program shall assume full responsibility for professional management of the patient's hospice care in accordance with the requirements of this chapter. (2) When a hospice care program delivers hospice care to a resident of a licensed health care facility, the hospice and the facility shall have a written agreement which defines their respective roles and responsibilities in regard to the care of the patient. (3) The hospice care program shall designate a qualified health care professional from the hospice care program who shall coordinate the activities of the interdisciplinary care team and the health care facility staff to assure continuous assessments of the patient's and family's needs, and to ensure implementation of an integrated plan of care. (4) All core hospice services, specifically, physician, nursing, social work, and counseling services identified in the plan of care, shall be provided directly by hospice care program employees or volunteers and may not be delegated to the health care facility. B. Plan of Care. (1) The interdisciplinary plan of care shall be jointly developed by the patient, the patient's family, the hospice care program, and the licensed health care facility, and shall identify the services to be provided by each entity. (2) Both providers shall review the interdisciplinary plan of care at intervals specified in the plan, and shall jointly update the plan as necessary to reflect the patient's current status. (3) Both the hospice care program and the health care provider shall maintain the interdisciplinary plan of care in their respective medical records. #### Regulation .26 Inpatient Hospice Care. *COMAR 10.07.21.26* A. In addition to the other requirements of this chapter, when a hospice care program delivers inpatient care, the hospice care program shall provide nursing services 24 hours a day in a manner sufficient to meet the total nursing needs identified in the patient's plan of care. A registered nurse shall be on duty during each shift. B. The hospice care program shall design and equip all areas for the comfort and privacy of patients and family members. Specifically, the hospice care program shall: (1) Provide accommodation for family members to remain with the patient throughout the night; (2) Provide an adequate supply of hot water at all times for patient use; (3) Have available at all times a quantity of linen sufficient for proper care and comfort of patients; (4) Make provisions for isolating patients with infectious diseases; and (5) Provide privacy for patient/family visitation and accommodations for the family's privacy immediately after a patient's death. C. The hospice care program shall provide food services designed to meet the nutritional needs of the patients, in accordance with physician orders and the following guidelines: (1) At least three meals shall be served each day with not more than 14 hours between the evening meal and breakfast, unless otherwise prescribed by the patient's physician; (2) All foods shall be stored, prepared, and served as required by COMAR 10.15.03; and (3) Medically prescribed special diets shall be planned by a registered dietitian or licensed nutritionist. D. In addition to all other State and federal requirements, all medications shall be labeled, stored, and administered in accordance with the following: (1) All medications shall be ordered by a physician; (2) All medications shall be administered by a licensed nurse or physician; (3) All medications shall be labeled in accordance with Health-General Article, §21-221(a), Annotated Code of Maryland, 21 U.S.C. §§301 et seq. and 801 et seq.; (4) All medications shall be stored in locked compartments under proper temperature control and all schedule II drugs shall be maintained separately from other medications and secured by use of two different locks; and (5) All medications no longer needed by the patient shall be destroyed in the presence of two witnesses authorized by the hospice care program. #### Regulation .27 Penalties. *COMAR 10.07.21.27* A. Administrative Penalty. (1) The Secretary may, for noncompliance with any regulation under this chapter, impose an administrative penalty of up to: (a) $500 for a first violation; and (b) $1,000 for a subsequent repeated violation. (2) When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors: (a) The number, nature, and seriousness of the violations; (b) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (c) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients; (d) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (e) Other factors as justice may require. B. Emergency Suspension. (1) The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action. (2) The Department shall deliver a written notice to the hospice care program: (a) Informing it of the emergency suspension; (b) Giving the reasons for the action, and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (c) Notifying the hospice care program of its right to request a hearing and to be represented by counsel. (3) The filing of a hearing request does not stay the emergency action. (4) When a license is suspended by emergency action: (a) The hospice care program shall immediately return the license to the Department; (b) The hospice care program shall stop providing hospice services immediately; and (c) The licensee shall notify the patients or their representatives of the suspension and make every reasonable effort to assist them in making other hospice service arrangements. (5) In the event of an emergency suspension, the Department may assist in the relocation of patients. (6) A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter. (7) The Office on Administrative Hearings shall conduct a hearing as set forth in Regulation .28 of this chapter and issue a proposed decision within 10 business days of the close of the hearing record. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. (8) If the Secretary's final decision does not uphold the emergency suspension, the hospice care program may resume operation. C. Suspension or Revocation of License. (1) The Secretary, for cause shown, may suspend or revoke the hospice care program's license. (2) The Department shall notify the hospice care program in writing of the following: (a) The effective date of the suspension or revocation; (b) The reason for the suspension or revocation; (c) The regulations with which the licensee has failed to comply that form the basis for the suspension or revocation; (d) That the hospice care program is entitled to a hearing if requested, and to be represented by counsel; (e) That the hospice care program shall stop providing services on the effective date of the suspension or revocation if the hospice care program does not request a hearing; (f) That the suspension or revocation shall be stayed if a hearing is requested; and (g) That the hospice care program is required to surrender its license to the Department if the suspension or revocation is upheld. (3) The licensee shall notify the patients or their representatives of any final suspension or revocation and make every reasonable effort to assist them in making other hospice care arrangements. The Department may assist in the relocation of residents. (4) A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .28 of this chapter. #### Regulation .28 Hearings. *COMAR 10.07.21.28* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Licensing and Certification Administration of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, §10-210 et seq., Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. ### Chapter 22 — Hospice Care Programs: Hospice House Requirements **Authority:** Health-General Article, §19-903, Annotated Code of Maryland **Administrative History:** Effective date: June 10, 2013 (40:11 Md. R. 975) #### Regulation .01 Scope and Purpose. *COMAR 10.07.22.01* A. This chapter is effective January 1, 2014. B. This chapter applies to all general hospice care programs that operate a hospice house. C. An operator of a hospice house shall also comply with all the requirements contained in COMAR 10.07.21 that are applicable to general hospice care programs. #### Regulation .02 Definitions. *COMAR 10.07.22.02* A. In addition to the definition contained in §B of this regulation, definitions set forth in COMAR 10.07.21.02 are applicable to this chapter. B. Terms Defined. (1) “Hospice house” means a residence operated by a Maryland licensed general hospice care program that provides home-based hospice services to hospice patients in a home-like environment and the care is not billed as general inpatient care. (2) “Primary hospice nurse” means the registered nurse who is assigned to oversee the nursing care of an individual hospice patient from the time of admission until the time of discharge. #### Regulation .03 Incorporation by Reference. *COMAR 10.07.22.03* In this chapter, the following document is incorporated by reference: NFPA 101, The Life Safety Code, as adopted by the State Fire Prevention Commission in COMAR 29.06.01. #### Regulation .04 License Required. *COMAR 10.07.22.04* A person may not operate a hospice house without first obtaining a license to operate a general hospice care program. #### Regulation .05 Staffing Plan. *COMAR 10.07.22.05* A. Following an analysis of the number of beds the hospice house intends to serve and the individual needs of each resident, the general hospice care program shall develop a staffing plan that identifies the type and number of staff needed to provide the services required by this chapter. B. The staffing plan shall include on-site staff sufficient in number and qualifications to meet the 24-hour scheduled and unscheduled needs of the residents. C. Relief personnel shall be available at all times in the event that the regularly scheduled staff members are unavailable. D. The staffing plan shall be reviewed annually and as needed. #### Regulation .06 Management of the Hospice House. *COMAR 10.07.22.06* A. The administrator of the general hospice care program shall identify a manager of the hospice house who has full responsibility for the day-to-day operations of the hospice house. B. The administrator shall evaluate the manager’s performance on an annual basis. C. In the absence of the hospice house manager, the hospice house shall remain under the continuous supervision of a designated individual with appropriate experience and training. #### Regulation .07 Staff Qualifications. *COMAR 10.07.22.07* A. The hospice house shall be staffed by sufficient numbers of personnel to ensure that the hospice house is capable of meeting the requirements of this chapter, and all applicable federal, State, and local laws and regulations. B. In addition to meeting all of the other qualifications and requirements for hospice employees, all hospice house staff shall participate in an orientation program and annual training to ensure competency in maintaining the hospice house and meeting the needs of residents in accordance with the plan of care. C. Staff who administer medications to residents shall meet all requirements of the Maryland Board of Nursing or Maryland Board of Physicians. D. Documentation of all required training shall be included in the employee’s personnel record. #### Regulation .08 Admission Requirements. *COMAR 10.07.22.08* A hospice patient appropriate for care in their own home who does not require general inpatient services may be eligible for care in a hospice house, in accordance with the hospice house admission policy. #### Regulation .09 Residential Agreement. *COMAR 10.07.22.09* A. Patients admitted to the hospice house or their representatives shall sign, before or at the time of admission, a patient agreement that: (1) Is a clear and complete statement of commitments agreed to by the parties and the services provided in the hospice house; (2) Is accurate, legible, and communicated in a language understandable to patient and family; and (3) Conforms to all applicable federal, State, and local laws and requirements. B. The residential agreement shall include, at a minimum: (1) The services to be provided by the hospice house; (2) An explanation of the hospice house’s complaint or grievance procedure; (3) Procedures to be followed in transferring the patient to another facility; (4) The availability of secure storage of patient’s belongings; (5) The patient’s and family’s rights and obligations concerning use of the hospice house, including common areas; (6) Written plan and provisions for continued emergency preparedness services; (7) An acknowledgement that the patient or the patient’s representative has reviewed all hospice house rules, requirements, restrictions, or special conditions that the general hospice program will impose on the patient; and (8) Admission and discharge policies and procedures including: (a) Those actions, circumstances or conditions which may result in the patient’s discharge from the hospice house; (b) The procedures which the hospice house shall follow if it intends to discharge a patient without the patient’s agreement, thereby terminating the residential agreement; and (c) The procedures which the patient shall follow if the patient wishes to terminate the residential agreement. C. The residential agreement shall include financial provisions, which include at a minimum: (1) Rate structure and payment provisions covering: (a) All rates to be charged to the patient, including but not limited to any non-service related charges; and (b) Payment arrangements and fees, if known, for third-party services not covered by the residential agreement, but arranged for by either the patient, patient’s representative, or the hospice house; and (2) Obligations of the hospice house and the patient, or the patient’s representative, as to: (a) Handling the finances of the patient; (b) Arranging and contracting for services not covered by the patient agreement; (c) Disposition of the patient’s property upon discharge or death of the patient; (d) Identification of the persons responsible for payment of all fees and charges and a clear indication of whether the person’s responsibility is or is not limited to the extent of the patient’s funds; (e) Fair and reasonable billing, payment, and credit policies; (f) The procedures the hospice house will follow in the event the patient or representative can no longer pay for services provided for in the patient agreement or for services or care needed by the patient; and (g) Terms governing the refund of any prepaid fees or charges in the event of a patient’s discharge from the hospice house or termination of the patient agreement. D. The hospice house shall maintain the patient agreement in the patient’s record. #### Regulation .10 Patient Record. *COMAR 10.07.22.10* The hospice house shall: A. Maintain the privacy and confidentiality of a patient’s medical records; B. Release medical records or medical information about a patient only with the consent of the patient or patient’s representative, or as permitted by Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and C. Maintain and dispose of a resident’s medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .11 Food. *COMAR 10.07.22.11* A. A patient’s food preferences shall be assessed at the time of admission. The assessment shall be maintained in the patient record. B. Patients shall be provided meals and snacks as requested. C. Patients shall be offered 3 meals and additional snacks during each 24-hour period, 7 days a week in accordance with their individual daily nutritional needs and preferences and consistent with their plan of care. D. Food that is prepared at the hospice house shall be prepared in accordance with all State and local sanitation and safe food handling requirements. E. Food preparation areas are to be maintained in accordance with all State and local sanitation and safe food handling requirements. F. Hospice house staff shall prepare or arrange for the provision of special diets consistent with the plan of care. G. Hospice house staff shall obtain food from sources that comply with all local laws and regulations relating to food, food processing, food handling, and food labeling. H. Hospice house staff shall protect food from contamination while being stored, prepared, displayed, served, or transported. I. Hospice house staff shall promptly discard the following: (1) Spoiled food; (2) Swelled, rusty, or leaky canned food; and (3) Foods exposed to fire, smoke, or water damage. J. The hospice house staff shall maintain kitchen surfaces, floors, walls, storage areas, equipment, appliances, and utensils in a clean and sanitary manner and in good repair. K. The hospice house staff shall provide refrigerator and freezer units operated in compliance with the manufacturer’s specifications. #### Regulation .12 Personal Care Services. *COMAR 10.07.22.12* The hospice house staff shall provide all necessary personal care services to the patient in accordance with the plan of care and as desired by the patient. #### Regulation .13 Medication Management and Administration. *COMAR 10.07.22.13* A. All medications shall be administered consistent with applicable requirements of COMAR 10.27.11. B. Medications and treatments shall be administered consistent with current medical orders and using acceptable professional standards of practice. C. All medications shall be stored in a secure location, at proper temperature. D. Each patient’s medications shall be stored in the original dispensed container; E. Each patient shall receive the medications that have been specifically prescribed for that patient in the manner that has been ordered. F. The hospice house staff shall document and report to the patient’s primary hospice nurse or the hospice nurse on call any symptoms or pain that are not relieved by the current medications and other interventions. G. The hospice house staff shall document and report to the patient’s primary hospice nurse or the hospice nurse on call any undesired side effects, adverse drug reactions, or medication errors. H. The medication administration documentation required under this regulation shall be recorded by a staff member at the time that the patient takes or receives medications on a medication administration report. This documentation shall be maintained in the patient record and include at minimum: (1) Name of the patient; (2) Date of birth; (3) Diagnosis; (4) Allergies; (5) Significant adverse drug reactions; (6) Name of the medication; (7) Reason for the medication; (8) Dose; (9) Authorized prescriber’s name; (10) Date of issuance, and (11) Directions for use. I. Accounting for Narcotic and Controlled Drugs. (1) The hospice house staff shall count and record controlled drugs at shift changes. (2) All controlled substances and all medications with a high abuse potential in the hospice house’s location shall be maintained under a double lock system. #### Regulation .14 Incident Reports. *COMAR 10.07.22.14* A. The staff of the hospice house shall complete an incident report in accordance with hospice policy within 24 hours of having knowledge that an incident has occurred. B. All incident reports shall include: (1) Time, date, place, and individuals present; (2) Complete description of the incident; (3) Response of the staff at the time; and (4) Follow up action, including notification to the: (a) Patient’s primary hospice nurse or hospice nurse on call; (b) Patient’s representative or family; (c) Patient’s attending physician or nurse practitioner; (d) Hospice medical director; and (e) Licensing or law enforcement authorities, when appropriate. #### Regulation .15 Relocation and Discharges. *COMAR 10.07.22.15* A. Relocation within the Facility. The hospice house may not relocate a patient within the facility except in accordance with the terms and conditions of the residential agreement. B. Discharge. (1) Discharge of a patient without the consent of the patient or the patient’s representative shall be in accordance with the residential agreement. (2) When the patient is discharged or transferred to another facility, the hospice house shall provide to the receiving facility all information that is required to ensure that continuity of care and services is maintained. (3) Within 30 days of the date of discharge, the hospice house shall: (a) Give the patient or patient’s representative a final statement of account and refunds due; and (b) Return any money, property, or valuables held in trust or custody by the hospice house. #### Regulation .16 Patient’s Rights. *COMAR 10.07.22.16* A. In addition to all other rights as a hospice patient, the patient residing in a hospice house has the right to: (1) Privacy, including the right to have a staff member knock on the patient’s door before entering; (2) Be free from mental abuse, verbal abuse, sexual abuse, physical abuse, neglect, involuntary seclusion, and exploitation; (3) Be free from physical and chemical restraints; (4) Manage personal financial affairs; (5) Maintain legal counsel; (6) Attend or not attend religious services as the patient chooses, and receive visits from members of the clergy; (7) Possess and use personal clothing and other personal effects to a reasonable extent, and to have reasonable security for those effects in accordance with the hospice house’s security policy; (8) Retain personal clothing and possessions as space permits with the understanding that the hospice house may limit the number of personal possessions retained at the facility for the health and safety of other patients; (9) Meet or visit privately with any individual the patient chooses in accordance with patient and facility safety; and (10) Have reasonable access to the private use of a telephone within the facility. B. Notice of Patient’s Rights. The hospice house shall: (1) Place a copy of the patient’s rights as set forth in this regulation, in a conspicuous location, plainly visible and easily read by patients, staff, and visitors; and (2) Provide a copy to the patient and patient’s representative on admission. #### Regulation .17 Abuse, Neglect, and Exploitation. *COMAR 10.07.22.17* A. The hospice house shall develop and implement policies and procedures prohibiting abuse, neglect, and exploitation of hospice house patients. B. Reports of Abuse, Neglect, or Exploitation. An employee of the hospice house who believes that a patient has been subjected to abuse, neglect, or exploitation shall report the alleged abuse, neglect, or exploitation within 24 hours to: (1) The appropriate local Department of Social Services, Adult Protective Services office, or Child Protective Services; and (2) One of the following: (a) A local law enforcement agency; or (b) The Office of Health Care Quality. C. Investigations. The hospice house shall: (1) Thoroughly investigate all allegations of abuse, neglect, or exploitation and maintain on-site written documentation of the investigation; and (2) Take appropriate action to prevent further incidents of abuse, neglect, or exploitation while the investigation is in progress. D. Immunity from Civil Liability; An individual who, acting in good faith, makes a report under this regulation has immunity from liability as described in Health-General Article, §19-347(g), Annotated Code of Maryland. E. Notice. The hospice house shall post signs that set forth the reporting requirements stated in §B of this regulation, conspicuously in the employee and public areas of the facility. #### Regulation .18 Restraint or Seclusion. *COMAR 10.07.22.18* A. A hospice house shall develop a policy and procedure related to restraint and seclusion. B. Relevant staff shall be trained in accordance with the facility’s policy and procedure related to restraint and seclusion. C. Patients have the right to be free from restraint or seclusion of any form which are imposed as a means of coercion, discipline, convenience, or retaliation by staff. D. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and shall be discontinued at the earliest possible time. E. The type or technique of restraint or seclusion used shall be the least restrictive intervention that will be effective to protect the patient, a staff member, or others from harm. F. The use of restraint or seclusion shall be: (1) In accordance with a written modification to the patient’s plan of care; and (2) Implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospice policy in accordance with applicable laws. G. All restraints shall be ordered by a physician and shall specify: (1) The purpose of the restraint; (2) The type of restraint to be used; and (3) The length of time the restraint shall be used. H. Restraint and seclusion orders may not be on an as-needed basis. I. A patient may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity. J. The patient’s primary hospice nurse or hospice nurse on call and hospice medical director or physician designee shall be consulted as soon as possible after the implementation of any restraint or seclusion to, as applicable: (1) Review and modify the plan of care; and (2) Determine if the hospice house is an appropriate setting for the patient at this time. K. The program shall notify the patient’s family or the patient’s representative each time a restraint is used. #### Regulation .19 General Physical Plant Requirements. *COMAR 10.07.22.19* A. The facility, which includes buildings, common areas, and exterior grounds, shall be kept: (1) In good repair; (2) Clean; (3) Free of any object, material, or condition that may create a: (a) Health hazard, accident, or fire; or (b) Public nuisance; and (4) Free of insect infestations and rodents. B. The hospice house shall provide adequate storage space, which is protected from the elements, for: (1) Excess supplies; (2) Some personal possessions of patients; and (3) Any other items in the patient’s room. #### Regulation .20 Water Supply. *COMAR 10.07.22.20* A. Approved Source. A facility shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be accepted if it is approved by the local jurisdiction in which the hospice house is located or a private certified vendor. B. Adequacy. The water supply shall be adequate in quantity and delivered under sufficient pressure to satisfactorily serve all fixtures in the facility. C. Hot Water Temperature. Hot water accessible to patients shall be blended externally to the hot water generator, by either individual point-of-use control valves of the anti-scald or thermostatic mixing valve type, to a maximum temperature of 120ºF and a minimum temperature of 110ºF at the fixture. #### Regulation .21 Sewage Disposal. *COMAR 10.07.22.21* The facility shall be served by an approved public sewage disposal system, if available. If an approved public sewage disposal system is not available, a private sewage disposal system may be accepted if approved by the local jurisdiction in which the program is located. #### Regulation .22 Security. *COMAR 10.07.22.22* The facility shall have policies and procedures in place to provide a secure environment for the patient, family, and staff. #### Regulation .23 Assist Rails. *COMAR 10.07.22.23* A. The hospice house shall provide assist rails in stairways used by patients and for all toilets, showers, and bathtubs used by patients. B. The hospice house with a licensed capacity of 17 or more beds shall also provide assist rails on both sides of corridors used by patients. #### Regulation .24 Emergency Preparedness. *COMAR 10.07.22.24* A. The facility shall be constructed consistent with: (1) All applicable local fire and building codes; and (2) The Life Safety Code, NFPA 101, including Chapter 24 of NFPA 101. B. Hand Extinguishers. Fire extinguishers shall be located on each floor and adjacent to, or in, special hazard areas, such as furnace rooms, boiler rooms, kitchens, or laundries. Fire extinguishers shall be of standard and approved types, and installed and maintained to be conveniently available for use at all times. The hospice house shall properly instruct staff in the use of fire extinguishers. C. Emergency Plan. (1) The hospice house shall develop an emergency plan that includes procedures that will be followed before, during, and after an emergency. The emergency plan shall address: (a) The evacuation, transportation, or shelter in-place of patients; (b) Notification to families, staff, and the Office of Health Care Quality regarding the action that will be taken concerning the safety and well-being of the patients; (c) Staff coverage, organization, and assignment of responsibilities; and (d) The continuity of operation, including: (i) Procuring essential goods, equipment, and services; and (ii) Relocation to alternate facilities. (2) The Hospice House shall have a signed agreement with the facility that will house the program’s patients during an emergency evacuation. (3) Upon request, the hospice house shall provide access to its emergency plan to local organizations for emergency management and for purposes of coordinating local emergency planning. (4) The hospice house shall prepare a summary of its evacuation procedures to provide to the patient, family member, or legal representative upon request. The summary shall, at a minimum: (a) List means of transportation to be used in the event of evacuation; (b) List alternative facilities to be used in the event of evacuation; (c) Describe means of communication with family members and legal representatives; and (d) Describe the role of the patient, family member, or legal representative in the event of evacuation. D. Evacuation Plans. The facility shall conspicuously post individual floor plans with designated evacuation routes on each floor. E. Emergency Electrical Power Generator. (1) Generator Required. A hospice house with 6 or more beds shall have an emergency electrical power generator on the premises. (2) Generator Specifications. The power source shall be a generating set and prime mover located on the program’s premises with automatic transfer. The emergency generator shall: (a) Be activated immediately when normal electrical service fails to operate; (b) Come to full speed and load acceptance within 10 seconds; and (c) Have the capability of 48 hours of operation from fuel stored on-site. F. Test of Emergency Power System. (1) The program shall test the emergency power system once each month. (2) During testing of the emergency power system, the generator shall be exercised for a minimum of 30 minutes under normal emergency facility connected load. (3) Results of the test shall be recorded in a permanent log book that is maintained for that purpose. G. The emergency power system shall provide lighting in the following areas of the facility: (1) Areas of egress and protection as required by COMAR 29.06.01 State Fire Prevention Code and Life Safety Code 101 as adopted by the State Fire Prevention Commission in COMAR 29.06.01; (2) Nurses’ station; (3) Medication area; (4) An area for emergency telephone use; (5) Boiler or mechanical room; (6) Kitchen; (7) Emergency generator location and switch gear location; (8) If applicable, elevator, if operable on emergency power; (9) If applicable, areas where life-support equipment is used; (10) If applicable, common areas or areas of refuge; and (11) If applicable, toilet rooms of common areas or areas of refuge. H. Emergency electrical power shall be provided for the following, if applicable: (1) Nurses’ call system; (2) At least one telephone in order to make and receive calls; (3) Fire pump; (4) Sewerage pump and sump pump; (5) If applicable, an elevator, if required, for evacuation purposes; (6) If necessary, heating equipment needed to maintain a minimum temperature of 70ºF (24ºC); (7) If applicable, life support equipment; and (8) Nonflammable medical gas systems. I. Common Areas or Areas of Refuge. If the emergency power system does not provide heat to all patient rooms and toilet rooms, the program shall provide common areas or areas of refuge for all patients. The areas shall meet the following requirements: (1) The common area or areas of refuge shall maintain a minimum temperature of 70ºF (24ºC); and (2) Heated toilet rooms shall be provided adjacent to the common areas or areas of refuge. J. Orientation. The hospice house shall: (1) Orient staff to the emergency plan and to their individual responsibilities within 24 hours of the commencement of job duties; and (2) Document completion of the orientation in the staff member’s personnel file through the signature of the employee. K. Drills. (1) Fire Drills. The hospice house shall: (a) Conduct fire drills at least quarterly on all shifts; and (b) Document completion of each drill. (2) Documentation. The hospice house shall: (a) Have the documentation referenced in §K(1)(b) of this regulation signed by all staff who participated in the drill; and (b) Maintain the documentation on file for a minimum of 2 years. L. Disaster Drill or Training Session. (1) The hospice house shall: (a) Conduct an annual disaster drill or training session, other than a fire drill, on all shifts; and (b) Document completion of each disaster drill or training session. (2) Documentation. The hospice house shall: (a) Have the documentation referenced in §L(1)(b) of this regulation signed by all staff who participated in the drill or training; and (b) Keep the documentation on file for a minimum of 2 years. #### Regulation .25 Smoking. *COMAR 10.07.22.25* The hospice house shall prohibit indoor smoking in accordance with COMAR 10.19.04 and COMAR 10.12.27. #### Regulation .26 Common Use Areas. *COMAR 10.07.22.26* A. Common Areas. The hospice house shall provide common areas for the use of patients and families. The common areas shall be of a size and furnished to accommodate the number of family members reasonably expected to attend the number of patients provided for by the hospice house capacity. B. Public Toilets. The hospice house shall provide public restrooms that are sufficient in number, and appropriately located, to serve family members and visitors. C. Dining Area. The hospice house shall provide a well-lit, adequately ventilated, and appropriately furnished dining area for the use of patients, families, and visitors. D. Kitchen. The hospice house shall have a kitchen that has adequate: (1) Storage, refrigerator, and freezer space for perishable and nonperishable foods; (2) Food preparation area or areas with cleanable surfaces; (3) Space and equipment to wash, sanitize, and store utensils; (4) Space to store and clean garbage cans within or outside the kitchen; (5) Ice making capabilities; and (6) Equipment for the preparation of food. #### Regulation .27 Patients’ Rooms and Furnishings. *COMAR 10.07.22.27* A. Patient rooms shall be of a size and with furnishings adequate for the hospice residence staff to provide care of the patient as required by the plan of care. B. Patient rooms shall provide accommodation for one family member to remain with the patient through the night. C. Patient rooms shall be for the private use of the assigned patient or patients. D. If a patient in a double occupancy room requests dividers, curtains, or screens between the beds to ensure privacy, the hospice house shall furnish them. E. The hospice house shall provide adequate closet or wardrobe space, conveniently located to allow each patient to keep personal items. #### Regulation .28 Bathrooms for Patients. *COMAR 10.07.22.28* A. Toilets. The hospice house shall provide toilets in a separate room or compartment with latching hardware for privacy. B. Lavatories. Buildings with one to eight occupants shall have a minimum ratio of one lavatory to four occupants. Buildings with nine or more occupants shall have a minimum ratio of one lavatory to four occupants and a minimum of one lavatory for each floor on which a patient room is located. C. Bathtubs or Showers. The hospice house shall provide patients with bathtubs or showers that are enclosed in a separate room or compartment that ensures privacy. #### Regulation .29 Illumination. *COMAR 10.07.22.29* A. The hospice house shall provide sufficient light to meet the patient’s needs. B. Common use areas, such as entrances, hallways, inclines, ramps, cellars, attics, storerooms, kitchens, and laundries, shall have sufficient artificial lighting to prevent accidents and promote efficient service. #### Regulation .30 Heating, Ventilation, and Air Conditioning. *COMAR 10.07.22.30* A. The hospice house may not use space heaters unless approved by the State or local fire authorities. B. Minimum Temperature. The facility shall have a system that provides in areas used by patients a minimum temperature of 70ºF in cold weather and a maximum temperature of 80ºF in hot weather. C. Temperature Control. The hospice house shall provide for each resident's room: (1) A thermostat; or (2) An approved mechanical device for modulating a room’s temperature, such as adjustable vanes in a hot air vent. D. The hospice house shall ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, and other noxious odors. The hospice house shall provide forced mechanical exhaust ventilation or an approved equivalent for: (1) All bathing compartments; (2) Toilet rooms; (3) Any area used for toileting; and (4) Soiled utility rooms. #### Regulation .31 Laundry. *COMAR 10.07.22.31* A. The hospice house shall furnish laundry service, either on-site or off-site. B. The hospice house shall ensure that the laundry is: (1) Adequate to meet the needs of the patients; (2) Processed and handled in a manner to prevent the spread of infection; and (3) Adequately sanitized by the use of sufficient hot water or appropriate chemical representatives, or a combination of both. C. The hospice house shall ensure that patient and facility laundry is washed and dried separately. D. Unless otherwise agreed by the program and the patient, dry cleaning services are not considered part of laundry services in this regulation. #### Regulation .32 Infection Control. *COMAR 10.07.22.32* A. The hospice house shall maintain an infection control program that protects patients, staff, and others by preventing and controlling infections and communicable diseases. B. The hospice house shall follow accepted standards of practice to prevent the transmission of infections and communicable diseases, including the use of standard precautions. C. The infection control program shall include the following: (1) Education of employees, contracted providers, patients, and family members about infection control, including their role in preventing the spread of infection and communicable diseases through daily activities; (2) Techniques for hand washing, respiratory protections, asepsis, as well as other means for limiting the spread of contagion; (3) Measures for the: (a) Screening and evaluation of health care workers, including all hospice staff, volunteers, and contract workers, including agency nurses and housekeeping staff for communicable diseases; and (b) Evaluation of staff and volunteers exposed to patients with non-treated communicable diseases; and (4) Monitoring staff for compliance with hospice policies and procedures related to infection control. #### Regulation .33 Pet Visitation. *COMAR 10.07.22.33* A. A hospice house shall have a policy and procedure related to pet visitations. B. Visiting dogs and cats shall have proof of a current rabies vaccination on file. C. If another patient has an allergy or a respiratory condition that is aggravated by an animal, the animal shall remain outside of areas where that resident may be. D. The hospice house has the right to restrict any pet from the hospice house. ## Subtitle 08 — Health Facilities Grants ### Chapter 01 — Construction Funds for Public and Nonprofit Nursing Homes **Authority:** Health-General Article, §2-104(b), Annotated Code of Maryland; Ch. 228, Acts of 1990 **Administrative History:** Effective date: **Administrative History:** Regulations .01—.09 adopted as an emergency provision effective November 13, 1985 (12:25 Md. R. 2469); emergency status expired March 13, 1986 **Administrative History:** Regulations .01—.09 adopted as an emergency provision effective April 2, 1986 (13:9 Md. R. 1019) (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulations .01—.09 adopted effective July 12, 1986 (13:13 Md. R. 1491) **Administrative History:** Chapter recodified from COMAR 10.08.19 to 10.08.01 and amended effective February 23, 1987 (14:4 Md. R. 417) **Administrative History:** Regulations .01 and .03—.10 amended effective December 5, 1994 (21:24 Md. R. 1988) **Administrative History:** Regulation .02 repealed effective December 5, 1994 (21:24 Md. R. 1988) **Administrative History:** Regulation .03B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .04A amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .06A amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .08B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .09C amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Annotation: The following chapters were originally adopted to govern the administration of construction funds for public and non-profit nursing homes. These chapters were repealed effective February 23, 1987 (14:4 Md. R. 417) and replaced by the current COMAR 10.08.01: **Administrative History:** 10.08.01 (1968) effective February 17, 1969; amended effective June 30, 1969 and June 11, 1975 (2:13 Md. R. 930) **Administrative History:** 10.08.02 (1972) effective April 5, 1973; amended effective June 11, 1975 (2:13 Md. R. 930) **Administrative History:** 10.08.03 (1975) effective September 17, 1975 (2:21 Md. R. 1340) **Administrative History:** 10.08.08 (1977) effective March 24, 1978 (5:6 Md. R. 465) **Administrative History:** 10.08.11 (1978) effective April 20, 1979 (6:8 Md. R. 656) **Administrative History:** 10.08.13 (1980) effective as an emergency provision August 11, 1980 (7:20 Md. R. 1872); effective permanently December 12, 1980 (7:25 Md. R. 2336) #### Regulation .01 Scope. *COMAR 10.08.01.01* A. These regulations govern the administration of construction funds for public and nonprofit nursing homes made available by the Nursing Home Loan Act of 1990, and subsequent similar Loan Acts. In addition, these regulations govern the administration of the assurances, residual requirements, and the State's right of recovery for those applicants that received construction funds under the Nursing Home Loan Acts of 1972, 1975, 1977, 1978, 1980, and 1985. B. It is the intent of the Department that State grant funds be used: (1) To assist applicants for the construction, expansion, renovation, and equipping of nursing home eligible under the Nursing Home Loan Act of 1990 and subsequent similar Loan Acts in accordance with these regulations; and (2) After the applicant has secured all funds available from other sources. #### Regulation .02 Repealed. *COMAR 10.08.01.02* #### Regulation .03 Definitions. *COMAR 10.08.01.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means a county, municipal corporation or nonprofit organization that seeks to obtain State grant funds under the Loan Acts. (2) “Certificate of Need” means a certificate issued by the Maryland Health Care Commission under Health-General Article, §19-101 et seq., Annotated Code of Maryland, for a health care project. (3) Construction. (a) “Construction” means construction of new buildings or additions to existing buildings and initial capital equipment, including plans, specifications, site improvements, surveys, and applicable engineers' and architects' fees. (b) “Construction” does not include the cost of land acquisition or the cost of off-site improvements. (4) “Department” means the Maryland Department of Health. (5) “Facility” means a nursing home that is wholly owned by and operated under the authority of a: (a) County or municipal corporation; or (b) Nonprofit organization. (6) “Grantee” means a county, a municipal corporation, or a nonprofit organization for which State grant funds under the Loan Act are approved by the Board of Public Works. (7) Initial Capital Equipment. (a) “Initial capital equipment” means items which: (i) Are necessary to furnish and initially operate a facility; (ii) With normal maintenance, have a life expectancy of at least 15 years; and (iii) Are of durable construction. (b) “Initial capital equipment” does not include items which: (i) Could be easily lost, damaged, or destroyed during normal usage; (ii) Could be easily stolen; (iii) Are likely to be technically obsolescent within 15 years; or (iv) Are intended to replace similar items already on hand. (8) “Loan Act” means: (a) The Nursing Home Loan Act of 1972, Chapter 119, Acts of 1972; (b) The Nursing Home Loan Act of 1975, Chapter 656, Acts of 1975; (c) The Nursing Home Loan Act of 1977, Chapter 703, Acts of 1977; (d) The Nursing Home Loan Act of 1978, Chapter 904, Acts of 1978; (e) The Nursing Home Loan Act of 1980, Chapter 713, Acts of 1980; (f) The Nursing Home Loan Act of 1985, Chapter 304, Acts of 1985; (g) The Nursing Home Loan Act of 1990, Chapter 228, Acts of 1990; and (h) All subsequent similar legislation. (9) “Nonprofit nursing home” means a nursing home which is or will be wholly owned by and operated under the authority of a nonprofit organization. (10) “Nonprofit organization” means: (a) A bona fide religious organization, or a chartered nonprofit corporation which is classified under §501(c)3 of the Internal Revenue Code as a nonprofit; and (b) That no part of the organization's or corporation's earnings inures to the benefit of an individual or is used for any purpose other than the maintenance and operation of the nursing home, the purchase of equipment to be used in the nursing home, or the expansion of the nursing home. (11) “Nursing home” means a comprehensive care facility as set forth in COMAR 10.07.02. (12) “Nursing Home Loan Act of 1972” means Chapter 119, Acts of 1972. (13) “Nursing Home Loan Act of 1975” means Chapter 656, Acts of 1975. (14) “Nursing Home Loan Act of 1977” means Chapter 703, Acts of 1977. (15) “Nursing Home Loan Act of 1978” means Chapter 904, Acts of 1978. (16) “Nursing Home Loan Act of 1980” means Chapter 713, Acts of 1980. (17) “Nursing Home Loan Act of 1985” means Chapter 304, Acts of 1985. (18) “Nursing Home Loan Act of 1990” means Chapter 228, Acts of 1990. (19) “Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter. (20) “Public nursing home” means a nursing home that is wholly owned and operated under the authority of a county or a municipal corporation. (21) “Renovation” means the work required to restore or modernize, or both, most or all of a nursing home. (22) “Secretary” means the Secretary of Health, or a designated representative. (23) “Wholly owned” includes leased property, if the project proposed by the applicant includes: (a) A lease agreement with the State for a State-owned building or State-owned property; or (b) A lease agreement: (i) Which is for a minimum of 15 years following the project completion or extends the right of purchase to the lessee, and (ii) In which the lessor consents to the recording of a notice of the State's right of recovery, under the Nursing Home Loan Act of 1990, Section 1, Paragraph (9), in the land records of the county or Baltimore City in which the facility is located. #### Regulation .04 Eligibility of Applicant for State Funds. *COMAR 10.08.01.04* A. To be eligible for State funds under the Loan Act of 1990 and subsequent similar Loan Acts, an applicant: (1) Shall be a county, a municipal corporation, or a nonprofit organization; (2) That is a nonprofit organization shall verify its nonprofit status to the Department through its articles of incorporation, or appropriate documentation from the Internal Revenue Service classifying the organization as nonprofit; (3) Shall have a Certificate of Need from the Maryland Health Care Commission, if a Certificate of Need is required for the project; (4) Shall be eligible for certification to participate in the Medical Assistance Program and shall agree to participate; (5) Shall certify that the nursing home meets the requirements of 42 U.S.C. §12101 et seq.; and (6) Shall be approved by the Secretary to receive a grant award. B. In determining the site or location of a facility, an applicant may not make a selection with the effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any programs to which this chapter applies, on the grounds of race, color, religion, disability, or national origin, or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Loan Act of 1990 or this chapter. #### Regulation .05 Priority of Eligible Projects. *COMAR 10.08.01.05* The Department shall determine the priority of applicants for State grant funds under the Loan Act of 1990 and subsequent similar Acts after consideration of: A. All eligible applications; B. The availability of unallocated State funds at the time an application is received; and C. Priorities established by the Department. #### Regulation .06 Application Procedure. *COMAR 10.08.01.06* A. An applicant shall direct an application for State grant funds authorized by the Loan Act of 1990 and subsequent similar Loan Acts to the Office of Capital Planning, Budgeting, and Engineering Services. B. The Department shall provide notice and information to the State Clearinghouse for intergovernmental review in accordance with COMAR 14.24.04. C. At the time of filing the application required by §A of this regulation, the applicant shall file a written statement with the Department containing the following material: (1) Current or intended program of services; (2) Admission policies for the nursing home; (3) Agreement to admit patients without discrimination on the basis of race, religion, national origin, creed, or color; (4) The number of personnel employed or to be employed at the nursing home, by occupation, and all perquisites, salaries, and any other funds paid or to be paid to these personnel; (5) Expenses incurred or to be incurred in operating the nursing home; (6) The schedule of rates charged or to be charged for services rendered; (7) If the nursing home is operating, a current, certified profit-and-loss statement and balance sheet for the most current fiscal year; and (8) If the applicant is applying for poverty funding under Regulation .09D of this chapter, an agreement that the majority of the individuals served by the applicant shall be poverty-designated clients, as defined in Regulation .09D of this chapter, for each year for a period of 15 years following the completion of the nursing home. D. If the application meets all pertinent criteria, the Secretary, in the Secretary's discretion, may approve that application and, if approved, shall recommend the application to the Board of Public Works, together with a written report stating that: (1) Notice and information have been provided to the State Clearinghouse; (2) The application has been approved by the Secretary, and when a federal grant is involved, the application has also been approved by the Secretary of Health and Human Services or other appropriate federal authority; and (3) The Secretary recommends that the Board of Public Works make available to the applicant State grant funds. #### Regulation .07 Assurances from Grantee. *COMAR 10.08.01.07* A. The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1972, 1975, 1977, and 1978: For a period of 15 years following the completion of a project, the grantee shall operate the nursing home as a public or nonprofit nursing home and the nursing home may not be sold, bargained, or transferred to a person, agency, or organization not qualified under these regulations without prior written approval of the Department and the Board of Public Works. B. The following assurance in this section applies to all grantees receiving construction funds under the Loan Act of 1980: For a period of 15 years following the completion of a project, the grantee shall operate the nursing home as a public or nonprofit nursing home and the nursing home may not be sold, bargained, or transferred to a person, agency, or organization not qualified under these regulations without prior written approval of the Secretary. C. The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1985, 1990, and subsequent similar Acts: For a period of 15 years following the completion of a project, the grantee shall operate the nursing home as a public or nonprofit nursing home and the nursing home may not be sold, bargained, or transferred to a person, agency, or organization not qualified under these regulations without prior written approval of the Board of Public Works. D. The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1972, 1975, 1977, 1978, 1980, 1985, 1990, and subsequent similar Acts: The grantee shall operate and maintain the completed nursing home in accordance with all applicable State and federal regulations and standards for comprehensive care facilities. E. The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1972, 1975, 1977, and 1978: Patients shall be admitted without discrimination on the basis of race, creed, color, sex, national origin, age, marital status, or handicap. F. The following assurance in this section applies to all grantees receiving construction funds under the Loan Acts of 1978, 1980, 1985, 1990, and subsequent similar Acts: The nursing home shall apply the same admissions standards to all persons. A Medicaid recipient shall receive the same consideration as any other candidate for admission. Quotas by class of payor are not allowed. G. For those grantees receiving State funds under the Loan Acts of 1972, 1975, 1977, and 1978, the grantee shall agree to provide uncompensated care annually at one of the following levels: (1) A grantee may advise the State that it does not intend to deny an individual admission to the facility because of the individual's inability to pay; (2) A grantee may advise the State that its level of uncompensated care for individuals unable to pay shall be equal to 10 percent annually of all State funds received under the applicable Nursing Home Loan Act; (3) A grantee may advise that the proposed level of uncompensated care shall be equal to 3 percent of the difference between the facility's annual operating cost and the sum of the annual Medicare and Medicaid reimbursements. H. For those grantees that received State funds under the Loan Act of 1980, the grantee shall agree to provide uncompensated care annually at one of the following levels: (1) The grantee shall advise the Department that its level of uncompensated care for individuals unable to pay shall be equal to 10 percent annually of all State funds received under the Nursing Home Loan Act of 1980; (2) The grantee shall advise the Department that the proposed level of uncompensated care shall be equal to 3 percent of the difference between the facility's annual operating cost and the sum of the annual Medicare and Medicaid reimbursements. I. If the grantee finds that the options in §G or H of this regulation are not feasible, the grantee shall propose an alternate option to the Department. This alternate proposal shall be reviewed by the Secretary in consultation with the grantee, and a determination shall be made as to its acceptability. #### Regulation .08 Residual Requirements of the Grantee. *COMAR 10.08.01.08* A. Annual Requirements. (1) For a period of 15 years following the completion of a project involving these grant funds, a grantee that received funds under the Loan Acts of 1972, 1975, 1977, 1978, 1980, 1985, 1990, and subsequent similar Loan Acts shall file written statements annually with the Department containing the following material: (a) The number of personnel employed at the nursing home, by occupation, and all perquisites, salaries, and any other funds currently paid to these personnel; (b) Fees or retainers paid directly or under contract to persons rendering services at the nursing home; (c) A current, certified, audited profit-and-loss statement and balance sheet for the nursing home; (d) Rates and fees charged for services at the nursing home; (e) Gifts or endowments received during the current year; (f) Patient days of service rendered, showing separately the days of service rendered to patients in the following classifications: (i) Self-paying; (ii) Below cost; (iii) Medicare; (iv) Medicaid; (v) Public assistance; and (g) Other supplemental information required by the Secretary. (2) For a period of 15 years following the completion of a project that receives poverty funding under Regulation .09D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty clients defined in Regulation .09D of this chapter. B. Insurance Requirements. (1) The applicant shall provide builders’ risk insurance during the entire period of project construction or renovation as follows: (a) The policy shall name the State as a loss payee; (b) The policy shall be endorsed to protect the State's interest in the nursing home; (c) The coverage shall be for an amount at least equal to the replacement cost of the nursing home; and (d) The grantee shall submit evidence of this insurance to the Office of Capital Planning, Budgeting, and Engineering Services. (2) Upon completion of a project, the grantee shall maintain for a period of 15 years all-risk insurance coverage as follows: (a) The coverage shall be for an amount at least equal to the replacement cost of the nursing home; (b) The policy shall name the State as a loss payee; (c) The policy shall be endorsed to protect the State's interest in the project; (d) The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Notification of cancellation of policy; (ii) Material loss covered by the policy; and (iii) Material changes in the policy; and (e) The grantee shall submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division. C. A grantee receiving grant funds under the Loan Acts of 1972, 1975, 1977, 1978, 1980, 1985, 1990, and subsequent similar Loan Acts, shall make available business records of the nursing home for verification by representatives of the Department or its designated agents during the entire period of work on the project and for a period of 15 years after the project has been completed. D. Extension of Time for Completion, and Other Changes. (1) The applicant shall promptly notify the Secretary if the applicant is unable to encumber funds: (a) In the manner approved by the Secretary; or (b) Within 2 years of the appropriation by the Maryland legislature. (2) The Secretary may grant a request by the applicant for a change in the manner or time of encumbrance of funds, including an extension of time, for good cause. E. Expenditures. State funds may not be expended until the grantee is in compliance with §B(1) of this regulation, and a notice of the right of recovery is recorded in the land records of the political jurisdiction in which the property is located. F. Penalties. If the grantee does not comply with §§A, B, and C of this regulation, the Secretary may: (1) Refuse to consider the grantee for any future funding under a Loan Act; and (2) Require an audit of the grantee. #### Regulation .09 Grant Limitations and Provisions. *COMAR 10.08.01.09* A. The provisions of these regulations apply to applicants for grants under the Loan Act of 1990 and subsequent similar Loan Acts. B. Use of Federal Grants. Federal grants available for a project shall be applied first to the cost of construction, expansion, renovation, and equipping of an eligible nursing home, before a State grant is expended. C. Limits on State Grant. (1) For a project without federal participation, a State grant may not be more than: (a) 50 percent of eligible costs, unless the project is approved for poverty funding; or (b) 75 percent of eligible costs, if a project is approved for poverty funding. (2) For a project with federal participation, a State grant may not be more than: (a) 50 percent of the eligible costs remaining after the federal grant has been applied, unless the project is approved for poverty funding; or (b) 75 percent of the eligible costs remaining after the federal grant has been applied, if a project is approved for poverty funding. (3) An applicant may not be eligible for retroactive participation in the cost of acquisition, construction, renovation, or purchase of equipment. (4) The grant shall include only those expenditures incurred or contracted for after the grant award is approved by the Board of Public Works, except as provided in §E of this regulation. D. Poverty Funding. An applicant is eligible for poverty funding for a nursing home, if the majority of individuals served by the nursing home: (1) Are certified by a local department of social services as eligible for the Disability Assistance and Loan Program (DALP) or Medical Assistance; (2) Are eligible for Supplemental Security Income benefits; or (3) Have income levels which do not exceed 150 percent of the federal poverty level. E. Application Costs. (1) An applicant shall pay the costs necessary to file the application, such as the costs for appraisals, architects' fees, surveys, and test borings. (2) If the project is recommended for funding by the Department, the Department shall review the costs expended under §E(1) of this regulation, and may recommend those costs to the Board of Public Works for inclusion in the grant award. F. Matching Funds. (1) An applicant shall provide from other sources matching funds equal to the total eligible cost of the project less the State grant award. (2) An applicant may not expend matching funds before the State grant award, unless the Board of Public Works approves otherwise. (3) The Department may not consider real or personal property, in-kind contributions, or funds expended before the date a grant award is approved by the Board of Public Works as matching funds. G. Prohibition Against Use of Funds for Religious Purposes. (1) A grantee may not use any portion of the proceeds of a State grant: (a) For the furtherance of sectarian religious instruction; or (b) In connection with the design or construction of any building used or to be used as a place of sectarian religious worship or instruction, or in connection with any program or department of divinity for any religious denomination. (2) Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been or is being used for a purpose prohibited by the Loan Act. #### Regulation .10 Right of Recovery. *COMAR 10.08.01.10* A. In the event of default under the terms of the Loan Acts and this chapter, nursing homes which received funds from the Loan Acts of 1975, 1977, 1978, 1980, 1985, 1990, and all subsequent Loan Acts are subject to the State's right of recovery as set forth in the Loan Acts. B. Grant funds received by nursing homes from the Loan Act of 1972 shall be recovered proportionably and in the same manner as federal funds are recovered under the provisions of Subchapter IV—Construction of Hospitals and Other Facilities, 42 U.S.C. §291 et seq., as set forth in that Loan Act. ### Chapter 02 — Construction Funds for Public and Nonprofit Community Mental Health, Addiction, and Developmental Disabilities Facilities **Authority:** Health-General Article, §§2-102, 24-601, et seq., Annotated Code of Maryland **Administrative History:** Effective date: February 23, 1987 (14:4 Md. R. 417) **Administrative History:** Regulations .01 and .03—.10 amended and Regulation .02 repealed effective December 5, 1994 (21:24 Md. R. 1988) **Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .05B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .07D amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .07E amended effective March 9, 1998 (25:5 Md. R. 369) **Administrative History:** Regulation .09B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Annotation: The following chapters were originally adopted to govern the administration of construction funds for public and nonprofit community mental health center components, addiction facilities, and developmental disabilities facilities. These chapters were repealed effective February 23, 1987 (14:4 Md. R. 417) and replaced by the current COMAR 10.08.02: **Administrative History:** 10.08.04 (1972) effective April 26, 1973; amended effective July 7, 1976 (3:14 Md. R. 746) **Administrative History:** 10.08.05 (1973) effective April 30, 1975 (2:9 Md. R. 677); amended effective July 7, 1976 (3:14 Md. R. 746) **Administrative History:** 10.08.06 (1974) effective September 17, 1975 (2:21 Md. R. 1340) **Administrative History:** 10.08.07 (1975) effective July 7, 1976 (3:14 Md. R. 747) **Administrative History:** 10.08.09 (1977) effective March 24, 1978 (5:6 Md. R. 466) **Administrative History:** 10.08.10 (1978) effective May 4, 1979 (6:9 Md. R. 727) **Administrative History:** 10.08.12 (1979) effective February 22, 1980 (7:4 Md. R. 347) **Administrative History:** 10.08.14 (1980) effective April 17, 1981 (8:8 Md. R. 720) **Administrative History:** 10.08.15 (1981) effective as an emergency provision July 15, 1981 (8:15 Md. R. 1296); effective permanently November 23, 1981 (8:23 Md. R. 1855) **Administrative History:** 10.08.16 (1982) effective January 17, 1983 (10:1 Md. R. 29) **Administrative History:** 10.08.17 (1983) effective as an emergency provision August 24, 1983 (10:19 Md. R. 1684); effective permanently March 12, 1984 (11:5 Md. R. 462) **Administrative History:** 10.08.18 (1984) effective as an emergency provision August 15, 1984 (11:18 Md. R. 1578); effective permanently December 31, 1984 (11: 26 Md. R. 2278) #### Regulation .01 Scope. *COMAR 10.08.02.01* A. These regulations govern the administration of State grant funds for public and nonprofit community mental health, addiction, and developmental disabilities facilities made available by the: (1) Community Mental Health, Addiction, and Developmental Disabilities Facilities Loan Act of 1989, Chapter 126, Laws of Maryland 1989, and similar Acts; (2) Maryland Consolidated Capital Bond Loan Act of 1990, Chapter 421, Laws of Maryland 1990, and similar Acts; (3) Maryland Consolidated Capital Bond Loan Act of 1991, Chapter 471, Laws of Maryland 1991 and similar Acts; and (4) Maryland Consolidated Capital Bond Loan Act of 1992, Chapter 4 (special session), Laws of Maryland 1992, and similar Acts. B. These regulations do not supersede, terminate, or abrogate the residual requirements of prior regulations adopted in accordance with the previous Acts which provided funds for these same purposes. The terms of the prior regulations, to the extent they conflict with these regulations, shall continue to govern the administration of funds for public and nonprofit facilities which receive, or have received, State grant funds authorized by Acts of years before 1992. C. It is the intent of the Department that State grant funds be used: (1) To assist eligible applicants for the construction, acquisition, renovation, and equipping of facilities eligible under the Act in accordance with these regulations; and (2) After the applicant has secured all funds available from other sources. #### Regulation .02 Repealed. *COMAR 10.08.02.02* #### Regulation .03 Definitions. *COMAR 10.08.02.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as a community mental health, addiction, or developmental disabilities facility. (2) “Act” means Health-General Article, §24-601 et seq., Annotated Code of Maryland. (3) “Addiction” means a disease which is characterized by a pattern of pathological use of alcohol or a drug, or both, with repeated attempts to control the use and with significant negative consequences in at least one of the following areas of life: (a) Financial; (b) Legal; (c) Medical; or (d) Psychosocial. (4) “Addiction facility” means any facility which provides or proposes to provide treatment for an addiction. (5) “Applicant” means a county, a municipal corporation, or a nonprofit organization that seeks to obtain State grant funds under the Act. (6) “Appropriate administration” means the Behavioral Health, Developmental Disabilities, or Prevention and Health Promotion Administration. (7) “Community mental health facility” means a facility where one or more of the following mental health programs is provided, or is proposed to be provided: (a) Inpatient services; (b) Outpatient services; (c) Partial care services, including day care services and night care services; (d) 24-hour emergency services; (e) Aftercare services; (f) Consultation services; (g) Education services; (h) Community rehabilitation services. (8) Construction. (a) “Construction” means construction of new buildings or additions to existing buildings and initial capital equipment, including plans, specifications, site improvements, surveys, and applicable engineers' and architects' fees. (b) “Construction” does not include the cost of land acquisition and the cost of off-site improvements. (9) “Department” means the Maryland Department of Health. (10) Developmental Disabilities Facility. (a) “Developmental disabilities facility” means any facility which provides or proposes to provide services for individuals with disabilities, whether the facility is hospital-based, a clinic, vocational, day, or a residential site. (b) For purposes of this definition, facility does not include a Veterans' Administration hospital. (11) “Facility” means a: (a) Public community mental health facility, addiction facility, or developmental disabilities facility that is wholly owned by, and operated under, the authority of a county or municipal corporation; or (b) Nonprofit community mental health facility, addiction facility, or developmental disabilities facility that is wholly owned by, and operated under, the authority of a nonprofit organization or corporation. (12) “Grantee” means a county, a municipal corporation, or a nonprofit organization or corporation for which State grant funds under the Act are approved by the Board of Public Works. (13) Initial Capital Equipment. (a) “Initial capital equipment” means items which: (i) Are necessary to furnish and initially operate a facility; (ii) With normal maintenance have a life expectancy of at least 15 years; and (iii) Are of durable construction. (b) “Initial capital equipment” does not mean items which: (i) Could be easily lost, damaged, or destroyed during normal usage; (ii) Could be easily stolen; (iii) Are likely to be technically obsolescent within 15 years; or (iv) Are intended to replace a similar item already on hand. (14) “Nonprofit facility” means a facility which is, or will be, wholly owned by and operated under the authority of a nonprofit organization. (15) “Nonprofit organization” means: (a) A bona fide religious organization, or a chartered nonprofit corporation which is classified under §501(c)3 of the Internal Revenue Code as a nonprofit organization; and (b) That no part of the organization's or corporation's earnings inures to the benefit of an individual or is used for any purpose other than the maintenance and operation of the facility, the purchase of equipment to be used in the facility, or the expansion of the facility. (16) “Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter. (17) “Public facility” means a facility that is wholly owned by and operated under the authority of a county or a municipal corporation. (18) “Renovation” means the work required to restore or modernize, or both, most or all of a facility. (19) “Secretary” means the Secretary of Health, or a designated representative. (20) Wholly Owned. (a) “Wholly owned” includes leased property, if the lease agreement is with the State for a State-owned building or State-owned property. (b) “Wholly owned” includes leased property which is not State-owned, if the: (i) Lease agreement is for a minimum of 30 years following the project completion or extends the right of purchase to the lessee; and (ii) Lessor consents to the recording of a notice of the State's right of recovery, under Health-General Article, §24-606, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located. #### Regulation .04 Eligibility of Applicant for State Grant Funds. *COMAR 10.08.02.04* A. To be eligible for State grant funds under the Act, an applicant shall: (1) Be a county, a municipal corporation, or a nonprofit organization; (2) Be recommended by the appropriate administration as a result of a proposal for a project conforming to the plans or program for services by that administration; (3) Have proposed a project which is in accord with the priorities of the Secretary; (4) Be eligible for licensing or certification under existing federal or State regulations, or both, when licensing or certification is required in order to provide treatment or services in the facility; (5) Be eligible for certification, and agree to participate, in Title XVIII and Title XIX of the Social Security Act, if applicable; (6) Have proposed a project which meets the handicap-accessibility requirements of COMAR 05.02.02, promulgated pursuant to Article 83B, §6-102, Annotated Code of Maryland, if applicable, and 42 U.S.C. §12101 et seq.; and (7) Be approved by the Secretary to receive a grant award. B. In determining the site or location of a facility, an applicant may not make a selection with the effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any programs to which this chapter applies, on the grounds of race, color, religion, disability, or national origin, or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Act or this chapter. #### Regulation .05 Application Procedure. *COMAR 10.08.02.05* A. An applicant shall apply for a grant to be used for construction, acquisition, renovation, and equipping of a facility by filing an application with the Department on a form provided by the Department. B. An applicant shall direct an application for State grant funds to the Office of Capital Planning, Budgeting, and Engineering Services. C. The Department shall provide notice and information to the State Clearinghouse for intergovernmental review in accordance with COMAR 14.24.04. D. The applicant shall comply with the application procedures in effect at the time of application, as prescribed by applicable federal and State regulations. E. At the time of filing the application, and before the authorization of an award of State grant funds, the applicant shall file a written statement with the Department containing the following materials: (1) Current or intended program of services; (2) The facility's admission policies, including: (a) Statements in which the applicant shall: (i) Agree to admit individuals on the basis of their need for services without regard to race, national origin, color, disability, religion, or ability to pay, (ii) According to law and these regulations, define clearly proposed limitations, if any, regarding age groups, illness, or disorder categories, and (iii) Give priority to individuals for admission to the facility who are certified by a local department of social services for assistance, and to individuals of low income; (b) For an applicant serving or intending to serve individuals in a developmental disabilities facility, an agreement to: (i) Serve only those clients for whom the Developmental Disabilities Administration has authorized services in accordance with COMAR 10.22.18 or Health-General Article, §7-403, Annotated Code of Maryland, or (ii) Obtain written permission from the Director, Developmental Disabilities Administration, before serving individuals not funded by the Developmental Disabilities Administration; (3) The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and other funds paid, or to be paid, to these personnel; (4) Expenses incurred, or to be incurred, in carrying out qualified facilities operations; (5) The schedule of rates charged, or to be charged, for services rendered; (6) If a facility is currently operating, a certified, audited profit-and-loss statement and balance sheet for the most current year; and (7) If the applicant is applying for poverty funding under Regulation .07E of this chapter, an agreement that the majority of the individuals served by the applicant shall be poverty-designated clients, as defined in Regulation .07E of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility. F. If the application meets all pertinent criteria, the Secretary, in the Secretary's discretion, may approve that application and, if approved, shall recommend the application to the Board of Public Works, together with a written report stating that: (1) Notice and information in the application have been provided to the State Clearinghouse; (2) The application has been approved by the Secretary, and when a federal grant is involved, the application has also been approved by the Secretary of Health and Human Services or other appropriate federal authority; and (3) The Secretary recommends that the Board of Public Works make available to the applicant State grant funds. #### Regulation .06 Priority of Awards. *COMAR 10.08.02.06* The Department shall determine the priority of applicants for State grant funds after consideration of: A. All eligible applications; B. Each project, by the appropriate administration, for conformance with the program or plans for these services established by the respective administrations; C. Priorities as established by the Department; D. The reasonableness of the projected capital, and operating costs and revenues, for the facility; E. The availability of State grant funds; F. The total unallocated State grant funds available at the time the application is received; and G. The readiness of the project to go before the Board of Public Works. #### Regulation .07 Grant Limitations and Provisions. *COMAR 10.08.02.07* A. The provisions of these regulations apply to applicants for grants under the Act. B. Use of Federal Grants. Federal grant funds available for a project shall be applied first to the cost of construction, acquisition, renovation, and initial capital equipment of the facility, before a State grant is expended. C. Community Development Block Grants. Community development block grants are considered as local matching funds and are not considered as federal grant funds. D. Limits on State Grant. (1) For a project without federal participation, a State grant may not be more than: (a) 50 percent of eligible costs, unless the project is approved for poverty funding; or (b) 75 percent of eligible costs, if a project is approved for poverty funding. (2) For a project with federal participation, a State grant may not be more than: (a) 50 percent of the eligible costs remaining after the federal grant has been applied, unless the project is approved for poverty funding; or (b) 75 percent of the eligible costs remaining after the federal grant has been applied, if a project is approved for poverty funding. (3) An applicant may not be eligible for retroactive participation in the: (a) Cost of: (i) Acquisition; (ii) Construction; and (iii) Renovation; or (b) Purchase of equipment. (4) The grant shall include only those expenditures incurred or contracted for after the grant award is approved by the Board of Public Works, except as provided in §F of this regulation. E. Poverty Funding. An applicant is eligible for poverty funding for a facility, if the majority of individuals served by the facility: (1) Are certified by a local department of social services as eligible for Family Investment Program (FIP) or Medical Assistance; (2) Are eligible for Supplemental Security Income benefits; or (3) Have income levels which do not exceed 150 percent of the federal poverty level. F. Application Costs. (1) An applicant shall pay the costs necessary to file the application, such as the costs for appraisals, architects' fees, surveys, and test borings. (2) If the project is recommended for funding by the Department, the Department shall review the costs expended under §F(1) of this regulation, and may recommend those costs to the Board of Public Works for inclusion in the grant award. G. Matching Funds. (1) The applicant shall provide from other sources matching funds equal to the total eligible cost of the project less the State grant award. (2) An applicant may not expend matching funds before the State grant award, unless the Board of Public Works approves otherwise. (3) The Department may not consider real or personal property, in-kind contributions, or funds expended before the date a grant award is approved by the Board of Public Works, as matching funds. H. Prohibition Against Use of Funds for Religious Purposes. (1) A grantee may not use any portion of the proceeds of a State grant: (a) For the furtherance of sectarian religious instruction; or (b) In connection with the design, acquisition, or construction of any building used, or to be used, as a place of sectarian religious worship or instruction, or in connection with any program or department of divinity for any religious denomination. (2) Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been, or is being, used for a purpose prohibited by the Act. #### Regulation .08 Use of Funds for Site Acquisition and Renovation. *COMAR 10.08.02.08* A. If the applicant is using both State funds and federal grant funds for site acquisition and renovation, then at least two State-approved appraisers shall determine that portion of the total cost applicable to the land site alone. The Department shall exclude this cost from State participation. B. If the applicant is acquiring a site with existing improvements and renovating the improvements for use as a community mental health, addiction, or developmental disabilities facility, and if the applicant will not be using a federal grant, then the total project costs, including costs applicable to the acquisition of this site and existing improvements, are eligible for State participation. C. In the circumstances outlined in §B of this regulation, at least two State-approved appraisers shall make an estimate of the market value of the site and existing improvements. State participation shall be limited to the lesser of the value approved by the Department of General Services based upon the appraisals or actual acquisition cost. D. If an applicant proposes to acquire a land site on which to construct a facility, the cost of the land is not eligible for State participation. #### Regulation .09 Residual Requirements of the Grantee. *COMAR 10.08.02.09* A. Annual Requirements. (1) For a period of 30 years following the completion of construction or renovation, or the acquisition of a facility involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material: (a) The number of personnel employed at the facility, by occupation, and all remunerations, retainers, perquisites, and expenses currently paid; (b) Fees or retainers paid directly or under contract to consultants and other persons rendering services at the facility; (c) A current, certified, audited profit-and-loss statement and balance sheet for the facility; (d) Rates and fees charged for services provided at the facility; (e) Gifts or endowments received during the current year; (f) Volume of service at the facility, such as the days of service rendered to inpatient clients, the number of day program clients and the number of days of service, or the number of outpatient clients and outpatient visits; and (g) Other supplemental information required by the Secretary. (2) For a period of 30 years following the completion of a project that receives poverty funding under Regulation .07E of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty-designated clients, as set forth in Regulation .07E of this chapter. B. Insurance Requirements. (1) The grantee shall provide builders’ risk insurance during the entire period of project construction or renovation as follows: (a) The policy shall name the State as a loss payee; (b) The policy shall be endorsed to protect the State's interest in the building; (c) The coverage shall be for an amount at least equal to the replacement cost of the facility; and (d) The grantee shall submit evidence of this insurance to the Office of Capital Planning, Budgeting, and Engineering Services. (2) On acquisition of a building or part of a building, the grantee shall provide all-risk insurance coverage as follows: (a) The coverage shall be for an amount at least equal to the replacement cost of the facility; (b) The policy shall name the State as a loss payee; (c) The policy shall be endorsed to protect the State's interest in the project; (d) The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Notification of cancellation of the policy, (ii) Material loss covered by the policy, and (iii) Material changes in the policy; and (e) The grantee shall: (i) Maintain this insurance for a period of 30 years, and (ii) Submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division. (3) Upon completion of a project, the grantee shall maintain, for a period of 30 years, all-risk insurance coverage as follows: (a) The coverage shall be for an amount at least equal to the replacement cost of the facility; (b) The policy shall name the State as a loss payee; (c) The policy shall be endorsed to protect the State's interest in the project; (d) The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Notification of cancellation of the policy, (ii) Material loss covered by the policy, and (iii) Material changes in the policy; and (e) The grantee shall submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division. C. During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the grantee shall make available the business records of the facility for verification by representatives of the Department or its designated agent. D. Extension of Time for Completion, and Other Changes. (1) The applicant shall promptly notify the Secretary if the applicant is unable to encumber funds: (a) In the manner approved by the Secretary; or (b) Within 2 years of the appropriation by the Maryland legislature. (2) The Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time, for good cause. E. Expenditures. State funds may not be expended until the grantee is in compliance with §B(1) and (2)(a)—(d) of this regulation, and a notice of the right of recovery is recorded in the land records of the county or Baltimore City in which the property is located. F. Penalties. If the grantee does not comply with §§A, B(2) and (3), and C of this regulation, the Secretary may: (1) Refuse to consider the grantee for any future funding under the Act; and (2) Require an audit of the grantee. #### Regulation .10 Right of Recovery. *COMAR 10.08.02.10* In the event of default under the terms of the Act and this chapter, a facility financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act. ### Chapter 03 — Construction Funds for Public and Nonprofit Adult Day Care Centers **Authority:** Health-General Article, §24-701 et seq., Annotated Code of Maryland **Administrative History:** Effective date: December 28, 1987 (14:26 Md. R. 2746) **Administrative History:** Regulations .01—.09 amended effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .04B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .06E amended effective March 9, 1998 (25:5 Md. R. 369); March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .08B amended effective March 26, 2018 (45:6 Md. R. 319) #### Regulation .01 Scope. *COMAR 10.08.03.01* A. These regulations govern the administration of State grant funds to counties, municipal corporations, and nonprofit organizations for conversion, acquisition, renovation, equipping, and construction of adult day care centers under the Adult Day Care Centers Loan Act of 1987, Health-General Article, §§24-701—24-707, Annotated Code of Maryland. B. These regulations do not supersede, terminate, or abrogate the residual requirements of prior regulations adopted in accordance with the previous Acts which provided funds for these same purposes. The terms of the prior regulations, to the extent they conflict with these regulations, shall continue to govern the administration of funds for public and nonprofit facilities which receive, or have received, State grant funds authorized by Acts of years before 1991. C. It is the intent of the Department that State grant funds be used: (1) To assist eligible applicants with the conversion, acquisition, renovation, equipping, and construction of adult day care center facilities, eligible under the Act in accordance with these regulations; and (2) After the applicant has secured all funds available from other sources. #### Regulation .02 Definitions. *COMAR 10.08.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as an adult day care center. (2) “Act” means Health-General Article, §§24-701—24-707, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of conversion, acquisition, renovation, equipping, and construction of an adult day care center. (3) “Adult day care center” means a nonresidential center that: (a) Serves the elderly, medically handicapped adults, or victims of Alzheimer's disease and related disorders; (b) Meets the definitions in Health-General Article, §14-201(b) or §14-301(b), Annotated Code of Maryland; and (c) Is licensed by the Department under COMAR 10.12.04. (4) “Applicant” means a county, municipal corporation, or nonprofit organization that seeks to obtain State grant funds under the Act. (5) “Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland. (6) “Building” means: (a) All or part of an existing or potential adult day care center and its surrounding real property; or (b) A facility proposed to be constructed for use as an adult day care center, and its surrounding real property. (7) Construction. (a) “Construction” means constructing new buildings or additions to existing buildings and initial capital equipment, including architects' fees. (b) “Construction” does not include the cost of land acquisition and the cost of off-site improvements. (8) “Conversion” means the work required to transform a building or part of a building for effective use as an adult day care center. (9) “Department” means the Maryland Department of Health. (10) “Eligible work” means that work for which the use of State funds is authorized under Health-General Article, §§24-701—24-707, Annotated Code of Maryland. (11) “Facility” means an adult day care center that is wholly owned by and operated under the authority of a: (a) County or municipal corporation; or (b) Nonprofit organization. (12) “Grant” means a State grant provided under the adult day care center loan program, unless the context clearly implies otherwise. (13) “Grantee” means a county, municipal corporation, or nonprofit organization for which State grant funds under the Act are approved by the Board of Public Works. (14) Initial Capital Equipment. (a) “Initial capital equipment” means items which: (i) Are necessary to furnish and initially operate a facility; (ii) With normal maintenance, have a life expectancy of at least 15 years; and (iii) Are of durable construction. (b) “Initial capital equipment” does not include items which: (i) Could be easily lost, damaged, or destroyed during normal usage; (ii) Could be easily stolen; (iii) Are likely to be technically obsolescent within 15 years; or (iv) Are intended to replace a similar item already on hand. (15) “Nonprofit adult day care center” means an adult day care center which is, or will be, wholly owned by and operated under the authority of a nonprofit organization. (16) “Nonprofit organization” means: (a) A bona fide religious organization, or a chartered nonprofit corporation which is classified under §501(c)3 of the Internal Revenue Code as nonprofit; and (b) That no part of the organization's or corporation's earnings inures to the benefit of an individual or is used for any purpose other than the maintenance and operation of the facility, the purchase of equipment to be used in the facility, or the expansion of the facility. (17) “Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter. (18) “Operating costs” means costs associated with the operation of an adult day care center. (19) “Project” means an existing or proposed adult day care center which receives or has received a State grant for eligible work. (20) “Public facility” means a facility that is wholly owned by and operated under the authority of a county or municipal corporation. (21) “Renovation” means the work required to restore or modernize, or both, an existing or proposed adult day care center. (22) “Secretary” means the Secretary of Health, or a designated representative. (23) “Wholly owned” includes leased property, if the lease agreement: (a) Is for a minimum of 30 years following the project completion or extends the right of purchase to the lessee; and (b) Consents to the recording of a notice of the State's right of recovery, by the lessor, under Health-General Article, §24-706, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located. #### Regulation .03 Eligibility of Applicant for State Grant Funds. *COMAR 10.08.03.03* A. To be eligible for State grant funds under the Act, an applicant shall: (1) Be a county, municipal corporation, or a nonprofit organization; (2) Be eligible for licensing under COMAR 10.12.04; (3) Have relevant experience providing related health or human services; (4) Be recommended by the Medical Care Policy Administration as a project conforming to the Administration's 5-year plan for these services; (5) Complete a feasibility study as specified and approved by the Medical Care Policy Administration; (6) Certify that the proposed facility will meet the handicap-accessibility requirements of COMAR 10.12.04 and 42 U.S.C. §12101 et seq.; (7) Be eligible for certification, and agree to participate in Title XVIII and Title XIX of the Social Security Act, if applicable; and (8) Be approved by the Secretary to receive a grant award. B. In determining the site or location of a facility, an applicant may not make a selection with the effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any programs to which this chapter applies, on the grounds of race, color, religion, disability, or national origin, or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Act or this chapter. #### Regulation .04 Application Procedure. *COMAR 10.08.03.04* A. An applicant shall apply for a grant to be used for conversion, acquisition, renovation, purchase of capital equipment, and construction by filing an application with the Department on a form provided by the Department. B. An applicant shall direct the application for State grant funds to the Office of Capital Planning, Budgeting, and Engineering Services. C. The Department shall provide notice and information to the State Clearinghouse for intergovernmental review in accordance with COMAR 14.24.04. D. The applicant shall comply with the application procedures in effect at the time of application, as prescribed by applicable federal and State regulations, including COMAR 10.12.04. E. At the time of filing the application, and before the authorization of an award of State grant funds, the applicant shall file a written statement with the Department containing the following material: (1) Current or intended program of services; (2) The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any other funds paid, or to be paid, to these personnel; (3) Expenses incurred or to be incurred in carrying out qualified facility operations; (4) Schedule of rates charged or to be charged for services rendered at the facility; (5) Agreement to admit persons on the basis of their need for services without regard to race, national origin, color, disability, or religion, and to define clearly proposed limitations, if any, regarding age groups, level of functional impairment, or disability; (6) If a facility is currently operating, a certified, audited profit-and-loss statement and balance sheet for the most current year; and (7) If the applicant is applying for poverty funding under Regulation .06F of this chapter, an agreement that the majority of the persons served by the applicant shall be poverty-designated clients, as defined in Regulation .06F of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility. F. If the application meets all pertinent criteria, the Secretary may approve that application and may recommend the application to the Board of Public Works, together with a written report stating that: (1) Notice and information in the application have been provided to the State Clearinghouse; (2) The application has been approved by the Secretary, and when a federal grant is involved, the application has also been approved by the Secretary of Health and Human Services or other appropriate federal authority under provisions of federal regulations; and (3) The Secretary recommends that the Board of Public Works make available to the applicant State grant funds. #### Regulation .05 Priority of Awards. *COMAR 10.08.03.05* The Department shall determine the priority of applicants to be awarded State grant funds after consideration of: A. All eligible applications; B. The 5-year plan of the Medical Assistance Policy Administration for these services; C. Priorities as established by the Department; D. The reasonableness of the projected capital, and operating costs and revenues, for the facility; E. The availability of State grant funds; F. The total of unallocated State grant funds available at the time the application is received; and G. The readiness of the project to go before the Board of Public Works. #### Regulation .06 Grant Limitations and Provisions. *COMAR 10.08.03.06* A. The provisions of these regulations apply to applicants for grants under the Act. B. Alternative Public Building. State funds may be used to acquire an existing building or part of a building for use as an adult day care center, or to plan, design, and construct an adult day care center, only if the local government and the Department certify to the Board of Public Works that a surplus school building or other public building appropriate for use as an adult day care center does not exist in the area where it is desired to locate a center. C. Use of Federal Grants. Any federal grants available for a project shall be applied first to the cost of the project, before a State grant is expended. D. Community Development Block Grants. Community development block grants are considered as local matching funds and are not considered as federal grant funds. E. Limits on State Grant. (1) For a project without federal participation, a State grant may not be more than: (a) 50 percent of eligible costs, unless the project is approved for poverty funding; or (b) 75 percent of eligible costs, if a project is approved for poverty funding. (2) For a project with federal participation, a State grant may not be more than: (a) 50 percent of the eligible costs remaining after the federal grant has been applied, unless the project is approved for poverty funding; or (b) 75 percent of eligible costs remaining after the federal grant has been applied, if a project is approved for poverty funding. (3) An applicant is not eligible for retroactive participation in the cost of acquisition, construction, renovation, or purchase of equipment. (4) The grant shall include only those expenditures incurred or contracted for after the grant award is approved by the Board of Public Works, except as provided in §G of this regulation. F. Poverty Fundings. An applicant is eligible for poverty funding for a facility if the majority of individuals served by the facility: (1) Are certified by a local department of social services as eligible for General Public Assistance or Medical Assistance; (2) Are eligible for Supplemental Security Income benefits; or (3) Have income levels which do not exceed 150 percent of the federal poverty level. G. Application Costs. (1) An applicant shall pay the costs necessary to file the application, such as the costs for appraisals, architects' fees, surveys, and test borings. (2) If the project is recommended for funding by the Department, the Department shall review the costs expended under §G(1) of this regulation and may recommend those costs to the Board of Public Works for inclusion in the grant award. H. Matching Funds. (1) The applicant shall provide from other sources matching funds equal to the total eligible cost of the project less the State grant award. (2) An applicant may not expend matching funds before the State grant award, unless the Board of Public Works approves otherwise. (3) The Department may not consider real or personal property, in-kind contributions, or, unless approved by the Board of Public Works under §H(2) of this regulation, funds expended before the date a grant award is approved by the Board of Public Works as matching funds. I. Prohibition Against Use of Funds for Religious Purposes. (1) A grantee may not use any portion of the proceeds of a State grant: (a) For the furtherance of sectarian religious instruction; or (b) In connection with the design, acquisition, or construction of any building used, or to be used, as a place of sectarian religious worship or instruction, or in connection with any program or department of divinity for any religious denomination. (2) Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been, or is being, used for a purpose prohibited by the Act. #### Regulation .07 Use of Funds for Site Acquisition and Renovation. *COMAR 10.08.03.07* A. If the applicant is using both State funds and federal grant funds for site acquisition and renovation, then at least two State-approved appraisers shall determine that portion of the total cost applicable to the land site alone. The Department shall exclude this cost from State participation. B. If the applicant is acquiring a site with existing improvements and renovating the improvements for use as an adult day care center, and if the applicant will not be using a federal grant, then the total project costs, including costs applicable to the acquisition of this site and existing improvements, are eligible for State participation. C. In the circumstances outlined in §B of this regulation, at least two State-approved appraisers shall make an estimate of the market value of the site and existing improvements. State participation is limited to the lesser of the value approved by the Department of General Services based upon the appraisals or actual acquisition cost. D. If an applicant proposes to acquire a land site on which to construct a facility, the cost of the land is not eligible for State participation. #### Regulation .08 Residual Requirements of the Grantee. *COMAR 10.08.03.08* A. Annual Requirements. (1) For a period of 30 years following the completion of conversion, acquisition, renovation, capital equipping, or construction of an adult day care center involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department, containing the following material: (a) The number of personnel employed at the facility, by occupation, and all remunerations, retainers, perquisites, and expenses currently paid; (b) Fees or retainers paid directly or under contract to consultants and other persons rendering services at the facility; (c) A current, certified, audited profit-and-loss statement and balance sheet for the facility; (d) Rates and fees charged for services provided at the facility; (e) Gifts or endowments received during the current year; (f) Volume of service at the adult day care center, such as days of service rendered to clients; and (g) Other supplemental information required by the Secretary. (2) For a period of 30 years following the completion of a project that receives poverty funding under Regulation .06F of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty-designated clients, as described in Regulation .06F of this chapter. B. Insurance Requirements. (1) The grantee shall provide builders' risk insurance during the entire period of project construction or renovation as follows: (a) The policy shall name the State as a loss payee; (b) The policy shall be endorsed to protect the State's interest in the building; (c) The coverage shall be for an amount at least equal to the replacement cost of the facility; and (d) The grantee shall submit evidence of this insurance to the Office of Capital Planning, Budgeting, and Engineering Services. (2) Upon acquisition of a building or part of a building, the grantee shall provide all-risk insurance coverage as follows: (a) The coverage shall be for an amount at least equal to the replacement cost of the facility; (b) The policy shall name the State as a loss payee; (c) The policy shall be endorsed to protect the State's interest in the project; (d) The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Notification of cancellation of the policy, (ii) Material loss covered by the policy, and (iii) Material changes in the policy; and (e) The grantee shall: (i) Maintain this insurance for a period of 30 years, and (ii) Submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division. (3) Upon completion of a project, the grantee shall maintain, for a period of 30 years, all-risk insurance coverage as follows: (a) The coverage shall be for an amount at least equal to the replacement cost of the facility; (b) The policy shall name the State as a loss payee; (c) The policy shall be endorsed to protect the State's interest in the project; (d) The policy shall be endorsed to notify the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Notification of cancellation of the policy, (ii) Material loss covered by the policy, and (iii) Material changes in the policy; and (e) The grantee shall submit evidence of this insurance annually to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division. C. During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the grantee shall make available business records of the adult day care center for verification by representatives of the Department or its designated agent. D. Extension of Time for Completion, and Other Changes. (1) The applicant shall promptly notify the Secretary if the applicant is unable to encumber funds: (a) In the manner approved by the Secretary; or (b) Within 2 years of the appropriation by the Maryland legislature. (2) The Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time, for good cause. E. Expenditures. State funds may not be expended until the grantee is in compliance with §B(1) and (2)(a)—(d) of this regulation, and a notice of the right of recovery is recorded in the land records of the county or Baltimore City in which the property is located. F. Penalties. If the grantee does not comply with §§A, B(2) and (3), and C of this regulation, the Secretary may: (1) Refuse to consider the grantee for any future funding under the Act; and (2) Require an audit of the grantee. #### Regulation .09 Right of Recovery. *COMAR 10.08.03.09* In the event of default under the terms of the Act and this chapter, an adult day care center financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act. ### Chapter 04 — Construction Funds for Public and Nonprofit Assisted Living Facilities **Authority:** Health-General Article, §§24-1001—24-1007, Annotated Code of Maryland **Administrative History:** Effective date: December 10, 2001 (28:24 Md. R. 2128) **Administrative History:** Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .05A amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .10B amended effective March 9, 1998 (25:5 Md. R. 369); March 26, 2018 (45:6 Md. R. 319) #### Regulation .01 Scope. *COMAR 10.08.04.01* A. This chapter governs the administration of State grant funds to counties, municipal corporations, and nonprofit organizations for conversion, acquisition, renovation, equipping, and construction of assisted living facilities under the Assisted Living Facilities Grant Program, Health-General Article, §§24-1001—24-1007, Annotated Code of Maryland. B. It is the intent of the Department that State grant funds be used: (1) To assist eligible applicants with the conversion, acquisition, renovation, equipping, and construction of assisted living facilities, eligible under the Act in accordance with this chapter; and (2) After the applicant has secured all funds available from other sources. #### Regulation .02 Definitions. *COMAR 10.08.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as an assisted living facility. (2) “Act” means Health-General Article, §§24-1001—24-1007, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of conversion, acquisition, renovation, equipping, and construction of an assisted living facility. (3) “Admission criteria” means criteria established by a facility for admitting individuals including limitations, if any, regarding age or level of functional medical impairment, or both. (4) “Assisted living facility” means a residential facility or facility-based program that: (a) Meets the definitions in Health-General Article, §19-1801, Annotated Code of Maryland; and (b) Is licensed by the Department under COMAR 10.07.14. (5) “Applicant” means a county, municipal corporation, or nonprofit organization that seeks to obtain State grant funds under the Act. (6) “Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland. (7) “Building” means: (a) All or part of an existing assisted living facility and its surrounding real property; (b) All or part of an existing facility to be converted to assisted living and its surrounding real property; or (c) A facility proposed to be constructed for use as an assisted living facility, and its surrounding real property. (8) Construction. (a) “Construction” means construction of new buildings or additions to existing buildings, including architects' fees and initial capital equipment. (b) “Construction” does not include cost of: (i) Demolition of improvements that return the land to unimproved condition; and (ii) Unimproved land acquisition and the cost of off-site infrastructure improvements, such as roads, water, and sewer. (9) “Conversion” means the work required to transform a building or part of a building for effective use as an assisted living facility. (10) “Default” means: (a) Transfer of property to a person, agency, or organization that would not qualify as an applicant, or that is not approved as a transferee by the Board of Public Works; (b) Failure to complete a project and obtain an occupancy permit; (c) Failure to commence operation of a facility within 1 year after obtaining an occupancy permit; or (d) Failure to qualify as a facility, as defined in §B(14) of this regulation. (11) “Department” means the Maryland Department of Health. (12) “Eligible person” means an individual who meets facility admission criteria. (13) “Eligible work” means that work for which the use of State funds is authorized under the Act. (14) “Facility” means an assisted living facility that is wholly owned by and operated under the authority of a: (a) County or municipal corporation; or (b) Nonprofit organization. (15) “Grant” means any funds competitively awarded from any source to the applicant including a State grant. (16) “Grantee” means a county, municipal corporation, or nonprofit organization for which State grant funds under the Act are approved by the Board of Public Works. (17) “Initial capital equipment” means items that: (a) With normal maintenance, have a life expectancy of at least 15 years; (b) Have durable construction; and (c) Are necessary to furnish a new facility. (18) “Nonprofit assisted living facility” means an assisted living facility which is wholly owned by and operated under the authority of a nonprofit organization. (19) “Nonprofit organization” means a bona fide religious organization, or a chartered nonprofit corporation which: (a) Is classified under §501(c)3 of the Internal Revenue Code as a nonprofit; and (b) Has no earnings which inure to the benefit of an individual or is used for any purpose other than the maintenance and operation of the facility, the purchase of equipment to be used in the facility, or the expansion of the facility. (20) “Office of Capital Planning, Budgeting, and Engineering Services” means the office within the Department designated by the Secretary to administer this chapter. (21) “Operating costs” means costs associated with the operation of an assisted living facility. (22) “Project” means an existing or proposed assisted living facility which receives or has received a State grant for conversion, acquisition, renovation, equipping, or construction. (23) “Public facility” means a facility that is wholly owned by and operated under the authority of a county or municipal corporation. (24) “Renovation” means restoration or modernization, or both, to an existing or proposed assisted living facility. (25) “Secretary” means the Secretary of Health, or a designated representative. (26) “State grant” means State funds awarded under the Assisted Living Facilities Grant Program, unless the context clearly implies otherwise. (27) “Wholly owned” includes leased property, if the lease agreement: (a) Is for a minimum of 30 years following the project completion or extends the right of purchase to the lessee; and (b) Includes a consent to the recording of a notice of the State's right of recovery, by the lessor, under Health-General Article, §24-1006, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located. #### Regulation .03 Use of State Grant Funds. *COMAR 10.08.04.03* A. State grant funds for assisted living facilities may be used for the following: (1) The conversion of public buildings or parts of buildings; (2) The acquisition of existing buildings or parts of buildings; (3) The renovation of assisted living facilities; (4) The purchase of initial capital equipment; or (5) The plan, design, and construction of an assisted living facility. B. State grant funds may be used to acquire an existing building or part of a building or to plan, design, and construct an assisted living facility only if the local government and the Department certify to the Board of Public Works that a surplus public building appropriate for use as an assisted living facility does not exist in the area in which the proposed assisted living facility is to be located. #### Regulation .04 Eligible Applicants for State Grant Funds. *COMAR 10.08.04.04* To be eligible to apply for State grant funds under the Act, an applicant shall: A. Be a county, municipal corporation, or a nonprofit organization; B. Sponsor a project involving work specified in Regulation .03A of this chapter; C. Have relevant experience providing related health or human services or provide evidence of intent to contract with a provider of assisted living services; and D. Certify that the proposed facility will meet the handicap-accessibility requirements of COMAR 10.07.14 and 42 U.S.C. §12101 et seq., or provide a certified waiver from the Department of Housing and Community Development. #### Regulation .05 Application Procedure. *COMAR 10.08.04.05* A. An applicant shall apply for a State grant by filing an application with the Department on a form provided by the Department, and shall direct the completed application for State grant funds to the Office of Capital Planning, Budgeting, and Engineering Services. B. The Department shall provide any notice and information to the State Clearinghouse for intergovernmental review that may be required under COMAR 14.24.04. C. The applicant shall comply with all applicable federal and State laws and regulations in effect at the time of application, including COMAR 10.07.14. D. At the time of filing the application, the applicant shall file a written statement with the Department containing the following material: (1) Current or intended program of services; (2) The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any compensation paid, or to be paid, to the personnel; (3) Expenses incurred, or to be incurred, in carrying out qualified facility operations; (4) Schedule of rates charged, or to be charged, for services rendered at the facility; (5) Agreement to admit eligible persons on the basis of their need for services without regard to race, religion, national origin, color, or disability; (6) If an applicant is currently operating, a certified, audited profit-and-loss statement and balance sheet for the most recent year; and (7) If the applicant is applying for poverty funding under Regulation .08D of this chapter, an agreement that the majority of the individuals served by the applicant will be poverty-designated clients, as defined in Regulation .08D(2) of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility. E. The Secretary shall approve applications that meet the requirements of this regulation and the priorities of the Department. #### Regulation .06 Amount of State Grant Awards. *COMAR 10.08.04.06* The Department shall determine the amount of the State grant for an applicant's project after consideration of the following: A. All eligible applications; B. Priorities of need as established by the Department; C. The total unallocated State funds available in the Department's Administration-Sponsored Capital Programs for Assisted Living at the time the application is received; D. The projected amount of anticipated appropriations as provided in the Governor's 5-Year Capital Improvement Program; E. The reasonableness of the total cost of the project; and F. Current operating costs or the reasonableness of a projected budget and revenues for the facility. #### Regulation .07 Recommendation of State Grant Awards. *COMAR 10.08.04.07* A. The Department shall determine whether the approved application is to be recommended to the Board of Public Works for award of State grant funds after consideration of the following: (1) The availability of State grant funds; (2) The receipt of satisfactory evidence from the applicant of the following requirements: (a) Sufficient total financial contribution to complete the project; (b) Control of site, such as deed or lease; (c) Compliance with applicable local zoning requirements; (d) Certification that the project site is located in a State-approved Smart Growth area; (e) Certified bid tabulation, construction contract, contract of sale, or 30-year lease agreement with landlord, contingent on Board of Public Works approval; and (f) Compliance with all other applicable provisions of State or federal law; and (3) Whether the local government has certified to the Department that a surplus public building appropriate for use as an assisted living facility does not exist in the area in which the facility is to be located, if a new building is to be constructed. B. Upon satisfactory completion of §A(1) and (2) of this regulation, the Secretary shall recommend to the Board of Public Works that a State grant be made to the approved applicant, together with a written report: (1) Stating that a notice, including information in the application, has been provided to the State Clearinghouse; (2) Stating that the application has been approved by the Secretary; (3) Stating the amount of a federal grant, if any is involved, that has been awarded to the applicant; (4) If required, stating that the local government has certified that there is no surplus public building; and (5) If required, certifying that there is no surplus public building. #### Regulation .08 Grant Limitations and Provisions. *COMAR 10.08.04.08* A. Use of Federal Grants and Other Grants. (1) Any federal or other grant that is received for an eligible project shall be applied first to the cost of the project. (2) All other sources of funds shall be expended before the State grant is expended on an approved project. B. Limits of State Grant. (1) Except as provided in §D(1) and (2) of this regulation, a State grant may not exceed 50 percent of the cost of eligible work remaining unpaid after all federal and other grants have been applied. (2) A State grant may not be used for retroactive participation in the cost of conversion, construction, renovation, acquisition, or purchase of equipment. (3) The State grant may include only those costs incurred or obligations contracted for after the application has been approved by the Department. (4) Costs necessary and appropriate for filing an application, such as appraisals, surveys, and test borings, shall be paid by the applicant. These costs may be approved for funding by the Board of Public Works, if the project is approved by the Board of Public Works. (5) State grant funds may not be used to pay certain costs. These costs include: (a) Closing costs; (b) Noncapital equipment; (c) Consultant services; (d) Land; (e) Off-site improvements; and (f) Amounts that exceed the appraised value of the real property. C. Exceptions on State Grant Limits. (1) The Department may request Board of Public Works approval for a State grant to exceed 50 percent of the cost of eligible work remaining unpaid after all federal and other grants have been applied, if: (a) The project involves the conversion of a public building or part of a building to an assisted living facility, the renovation of an assisted living facility, or the planning, design, and construction of an assisted living facility; (b) The value of real property and improvements made available by the local government, or the value of the center to be renovated, equals or exceeds the amount of the State grant; (c) State funds have not been used for the acquisition, construction, or maintenance of any real property and improvements made available by the local government or any building to be converted or renovated; and (d) The State is not responsible for any bonded indebtedness in connection with any real property and improvements made available by the local government or any building to be converted or renovated. (2) A project designated as eligible for poverty area under §D of this regulation may receive a State grant to cover up to 75 percent of the cost of eligible work remaining unpaid after all federal and other grants have been applied. D. Poverty Area Funding. An applicant is eligible for poverty area funding for a facility if: (1) The project complies with all applicable federal regulations and State plans or Departmental regulations; and (2) The majority of individuals served by the facility: (a) Are certified by a local department of social services as eligible for General Public Assistance or Medical Assistance; (b) Are eligible for Supplemental Security Income benefits; or (c) Have income levels which do not exceed 150 percent of the federal poverty level. E. Funding Contribution Requirements (1) The applicant shall provide, from other sources, funds equal to the total cost of the eligible project less the State grant award. (2) The applicant shall assume the risk of all costs associated with the project that are incurred before the date of approval of a State grant award by the Board of Public Works. (3) An applicant may not expend the State grant award before other sources of funds are expended unless the Board of Public Works approves otherwise. (4) The Department may not consider as contributions: (a) Real or personal property; (b) In-kind contributions; or (c) Unless approved by the Board of Public Works under §B(4) of this regulation, funds expended before the date a grant award is approved by the Board of Public Works. F. Prohibition Against Use of the Project for Purposes Other Than Assisted Living. (1) A grantee may not use a project funded by a State grant primarily: (a) For the furtherance of sectarian religious instruction or services; (b) As a place of sectarian religious worship or instruction, or primarily in connection with any program or department of divinity for any religious denomination; or (c) For any purpose other than assisted living. (2) Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant has been, or is being, used for a purpose prohibited by the Act. #### Regulation .09 Use of Funds for Acquisition and Renovation. *COMAR 10.08.04.09* A. If the applicant is acquiring a site with existing improvements, and the existing improvements are to be renovated for or used for an assisted living facility, the total project costs may be eligible for State participation. B. In the circumstances outlined in §A of this regulation, at least two State-approved appraisers shall provide appraisals of the site and existing improvements to be acquired. State participation shall be limited to the lesser of the appraised value approved by the Department of General Services based upon the appraisals or the actual acquisition cost. C. If an applicant proposes to acquire an unimproved land site on which to construct a facility, the cost of the land is not eligible for State participation. #### Regulation .10 Residual Requirements of the Grantee. *COMAR 10.08.04.10* A. Annual Requirements. (1) For a period of 30 years following the completion of conversion, acquisition, renovation, capital equipping, or construction of an assisted living facility involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material: (a) A recent certified, audited profit-and-loss statement and balance sheet for the facility; (b) Volume of service at the assisted living facility, such as days of service rendered to clients; and (c) Other supplemental information required by the Secretary. (2) For a period of 30 years following the completion of a project that receives poverty funding under Regulation .07D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving poverty-designated clients. B. Insurance Requirements. (1) Upon acquisition of the project, the grantee shall provide an all-risk insurance policy that: (a) Provides coverage for an amount at least equal to the replacement cost of the facility; (b) Names the State as a loss payee; (c) Protects the State's interest in the project; and (d) Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Cancellation of policy; (ii) Material loss covered by the policy; or (iii) Material changes in the policy. (2) The grantee shall provide builders' risk insurance coverage during the entire period of project construction or renovation that: (a) Names the State as a loss payee; (b) Protects the State's interest in the building; (c) Provides an amount at least equal to the replacement cost of the facility; and (d) Requires evidence of the coverage be submitted to the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201. (3) Upon completion of a project, the grantee shall maintain, for a period of 30 years, an all-risk insurance policy that: (a) Provides coverage for an amount at least equal to the replacement cost of the facility; (b) Names the State as a loss payee; (c) Protects the State's interest in the project; (d) Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Cancellation of policy; (ii) Material loss covered by the policy; or (iii) Material changes in the policy. (4) The grantee shall maintain and submit evidence of this insurance annually, for a period of 30 years, to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division. C. During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the Department may audit the business records of the applicant and the applicant's agents, contractors, or assigns. D. Extension of Time for Completion, and Other Changes. (1) The applicant shall promptly notify the Secretary, if the applicant is unable to encumber funds: (a) In the manner approved by the Secretary; or (b) Within 2 years of the appropriation by the Maryland legislature. (2) For good cause the Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time. (3) Upon a demonstration of good cause for an extension of time, the Secretary may grant an extension of an additional 180 days to encumber funds. (4) Absent good cause, the applicant shall be ineligible for grant funds. The applicant may apply for funds in future years. E. Expenditures. State funds may not be released until the applicant has a notice of the right of recovery recorded in the land records of the county or Baltimore City in which the property is located, and the applicant is in compliance with this chapter and applicable federal and State laws. F. Penalties. If the grantee does not comply with this chapter and all other applicable State and federal laws, the Secretary may: (1) Refuse to consider the grantee for any future funding under the Act; (2) Require an audit of the grantee; (3) Notify the Office of Health Care Quality; and (4) Take other action as appropriate. #### Regulation .11 Right of Recovery. *COMAR 10.08.04.11* In the event of default under the terms of the Act and this chapter, an assisted living facility financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act. ### Chapter 05 — Construction Funds for Federally Qualified Health Centers **Authority:** Health-General Article, §§24-1301—24-1307, Annotated Code of Maryland **Administrative History:** Effective date: April 24, 2006 (33:8 Md. R. 732) **Administrative History:** Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .05A amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .10B amended effective March 26, 2018 (45:6 Md. R. 319) #### Regulation .01 Scope. *COMAR 10.08.05.01* A. This chapter governs the administration of State grant funds to counties, municipal corporations, nonprofit corporations and other entities, hereinafter “entities”, that are authorized for funding under §330 of the Public Health Service Act (42 U.S.C. 254b) administered by the United States Department of Health and Human Services, Health Resources and Services Administration, Bureau of Primary Health Care. These grants are for the conversion, acquisition, renovation, equipping, and construction of federally qualified health centers under the Federally Qualified Health Centers Grant Program, Health-General Article, §§24-1301—24-1307, Annotated Code of Maryland. B. It is the intent of the Department that State grant funds be used: (1) To assist eligible applicants with the conversion, acquisition, renovation, equipping, and construction of federally qualified health centers, eligible under the Act in accordance with this chapter; and (2) After the applicant has secured all funds available from other sources. #### Regulation .02 Definitions. *COMAR 10.08.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquisition” means purchasing and obtaining ownership of all or part of an existing building for use as a federally qualified health center. (2) “Act” means Health-General Article, §§24-1301—24-1307, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of conversion, acquisition, renovation, equipping, and construction of a federally qualified health center. (3) “Admission criteria” means criteria established by a facility for admitting individuals including limitations, if any. (4) “Applicant” means a qualified entity that has submitted an application. (5) “Application” means the forms required and published by the Department, and submitted by the applicant to the Office of Capital Planning, Budgeting, and Engineering Services, to apply for a State grant for a project. (6) “Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland. (7) “Building” means: (a) All or part of an existing federally qualified health center; (b) All or part of an existing facility to be converted to a federally qualified health center; or (c) A facility proposed to be constructed on a designated site for use as a federally qualified health center. (8) “Capital equipment” means items that: (a) With normal maintenance, have a life expectancy of at least 15 years; and (b) Have durable construction. (9) Construction. (a) “Construction” means construction of new buildings or additions to existing buildings, including architects' fees and capital equipment. (b) “Construction” does not include cost of: (i) The demolition of improvements that return the land to unimproved condition; (ii) The acquisition of unimproved land, and (iii) The construction of off-site infrastructure improvements, such as roads, water, and sewer. (10) “Conversion” means the work required to transform a building or part of a building for effective use as a federally qualified health center. (11) “Default” means: (a) Transfer of property that has ceased to be a federally qualified health center to any person, agency, or organization that would not qualify as an applicant, or that is not approved as a transferee by the Board of Public Works; (b) Failure to complete a project and to obtain a required occupancy permit; (c) Failure to commence operation of a facility within 1 year after obtaining an occupancy permit; or (d) Failure to qualify as a facility, as defined in §B(15) of this regulation. (12) “Department” means the Maryland Department of Health. (13) “Eligible person” means an individual who meets facility admission criteria. (14) “Eligible work” means work for which the use of State funds is authorized under the Act. (15) “Facility” means a building that is wholly owned by and operated under the authority of a federally qualified health center. (16) “Federally qualified health center” has the meaning stated in Health-General Article, §24-1301, Annotated Code of Maryland. (17) “Grant” means any funds competitively awarded from any source to the applicant including a State grant. (18) “Grantee” means a federally qualified health center that receives State grant funds under the Act, which are approved by the Board of Public Works. (19) “Nonprofit organization” has the meaning stated in Health-General Article, §24-1301, Annotated Code of Maryland. (20) “Office of Capital Planning, Budgeting, and Engineering Services” means the unit within the Department designated by the Secretary to administer this chapter. (21) “Operating costs” means costs associated with the operation of a federally qualified health center. (22) “Project” means a proposed scope of work for the conversion, acquisition, renovation, equipping or construction of a facility. (23) “Qualified entity” means: (a) An entity designated as a federally qualified health center; (b) A nonprofit organization seeking a “new start” status; (c) A federally qualified health center applying for a new site designation; or (d) A federally qualified health center applying for a “change of scope” under the Federal Public Health Service Act, §330 (42 U.S.C. §254b) that: (i) Has been invited by the Health Resources Services Administration to submit a full application for federally qualified health center designation; and (ii) Seeks to obtain State grant funds under the Act. (24) “Renovation” means restoration or modernization, or both, to an existing or proposed Federally Qualified Health Center. (25) “Retroactive expenditure” means any cost incurred or contracted for before the application for conversion, construction, acquisition, renovation, and equipment has been received and approved by the Secretary. (26) “Secretary” means the Secretary of Health, or a designated representative. (27) “State grant” means State funds awarded under the Federally Qualified Health Centers Grant Program, unless the context clearly implies otherwise. (28) “Wholly owned” includes leased property, if the lease agreement: (a) Is for a minimum of 15 years following the project completion or extends the right of purchase to the lessee; and (b) Includes a consent to the recording of a notice of the State's right of recovery, by the lessor, under Health-General Article, §24-1306, Annotated Code of Maryland, in the land records of the county or Baltimore City in which the facility is located. #### Regulation .03 Use of State Grant Funds. *COMAR 10.08.05.03* State grant funds for federally qualified health centers shall be used solely for approved projects that involve: A. Conversion of public buildings or parts of buildings; B. Acquisition of existing buildings or parts of buildings; C. Renovation of a facility; D. Purchase of capital equipment; or E. Planning, design, and construction of a facility. #### Regulation .04 Eligible Applicants for State Grant Funds. *COMAR 10.08.05.04* To be eligible to apply for State grant funds under the Act, an applicant shall: A. Be a qualified entity; B. Sponsor a project involving work specified in Regulation .03 of this chapter; and C. Certify that the proposed facility will meet the handicap-accessibility requirements of 42 U.S.C. 12101 et seq., or provide a certified waiver from the Department of Housing and Community Development. #### Regulation .05 Application Procedure. *COMAR 10.08.05.05* A. An applicant shall apply for a State grant by completing an application with the Department on a form provided by the Department, and shall file the completed application for State grant funds with the Office of Capital Planning, Budgeting, and Engineering Services. B. The Department shall provide any notice and information to the State Clearinghouse for Intergovernmental Assistance that may be required under COMAR 14.24.04. C. The applicant shall comply with all applicable federal and State laws and regulations in effect at the time of application. D. At the time of filing the application, the applicant shall file a written statement with the Department containing the following information or material: (1) Current or intended program of services; (2) The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any compensation paid, or to be paid, to the personnel; (3) Expenses incurred, or to be incurred, in carrying out qualified facility operations; (4) Schedule of rates charged, or to be charged, for services rendered at the facility; (5) Agreement to admit eligible persons on the basis of their need for services without regard to race, religion, national origin, color, or disability; (6) If an applicant is currently operating as a federally qualified health center, a certified, audited profit-and-loss statement and balance sheet for the most current year; (7) If the applicant is applying for poverty funding under Regulation .08D of this chapter, an agreement that the majority of the individuals served by the applicant will be poverty-designated clients, as defined in Regulation .08D(2) of this chapter, for each year for a period of 30 years following the completion or acquisition of the facility; and (8) Letter from Health Resources Services Administration (HRSA) granting federally qualified health center status to the nonprofit and designated site or a letter from HRSA stating that the “need” score in the applicant's letter of intent is competitive and invites the applicant to submit a full application for designation as a federally qualified health center. E. The Secretary shall approve applications that meet the requirements of this regulation and that set forth the priorities of the Department as stipulated in the annual application instructions. #### Regulation .06 Amount of State Grant Awards. *COMAR 10.08.05.06* The Department shall determine the amount of the State grant, if any, for an applicant's approved project after consideration of the following: A. All approved applications; B. Priorities of need as established by the Department; C. The total unallocated State funds available in the Department's Administration-Sponsored Capital Programs for federally qualified health centers; D. The projected amount of anticipated appropriations as provided in the Governor's Five-Year Capital Improvement Program; E. The reasonableness of the total cost of the project; and F. Current operating costs or the reasonableness of a projected budget and revenues for the facility. #### Regulation .07 Recommendation of State Grant Awards. *COMAR 10.08.05.07* A. The Department shall determine whether the application is to be recommended to the Board of Public Works for award of State grant funds after consideration of the following: (1) The availability of State grant funds; (2) The receipt of satisfactory evidence from the applicant of the following requirements: (a) Sufficient total financial contribution to complete the project; (b) Control of site, such as deed or lease; (c) Compliance with applicable local zoning requirements; (d) Certified bid tabulation, construction contract, contract of sale, or 30-year lease agreement with landlord, contingent upon Board of Public Works approval; and (e) Compliance with all other applicable provisions of State or federal law. B. Upon satisfactory completion of §A of this regulation, the Secretary shall recommend to the Board of Public Works that a State grant be made to the approved applicant, together with a written report stating that: (1) A notice, including information in the application, has been provided to the State Clearinghouse for Intergovernmental Assistance; (2) The application has been approved by the Secretary; (3) The amount of a federal grant, if any is involved, that has been awarded to the applicant; #### Regulation .08 Grant Limitations and Provisions. *COMAR 10.08.05.08* A. Use of Federal Grants. (1) Any federal grant that is received for an eligible project shall be applied first to the cost of the project. (2) Community Development Block Grants are considered as local matching funds and are not considered as federal grant funds. (3) All other sources of funds shall be expended before any or all of the State grant is expended on an approved project. B. Limits of State Grant. (1) Except as provided in §D of this regulation, a State grant may not exceed 50 percent of the cost of eligible work remaining unpaid after all federal grants have been applied. (2) A State grant may not be used to fund participation in retroactive expenditures. (3) A State grant may include only those costs incurred or obligations contracted for eligible work after the application has been approved by the Secretary. (4) Costs necessary and appropriate for filing an application, such as appraisals, surveys, and test borings, shall be paid by the applicant. These costs may be approved for funding by the Board of Public Works, if the project is approved by the Board of Public Works. (5) State grant funds may not be used to pay the following costs: (a) Closing costs; (b) Noncapital equipment; (c) Consultant services; (d) Land; (e) Off-site improvements; and (f) Amounts that exceed the appraised value of the real property. C. Exceptions on State Grant Limits. A project designated as eligible for poverty area funding under §D of this regulation may receive a State grant to cover up to 75 percent of the cost of eligible work remaining unpaid after all federal grants have been applied. D. Poverty Area Funding. An applicant is eligible for poverty area funding for a facility if: (1) The project is designated as eligible for poverty area funding under applicable federal regulations and State plans or Departmental regulations; and (2) The majority of individuals served by the facility: (a) Are enrolled in the Maryland Medical Assistance Program; (b) Are eligible for Supplemental Security Income benefits; or (c) Have income levels which do not exceed 150 percent of the federal poverty level. E. Funding Contribution Requirements. (1) The grantee shall provide, from other sources, funds equal to the total cost of the eligible project less the State grant award. (2) The grantee shall assume the risk of all costs associated with the project that are incurred before the date of approval of a State grant award by the Board of Public Works. (3) A grantee may not expend the State grant award before other sources of funds are expended. (4) The Department may not consider as contributions: (a) Real or personal property; (b) In-kind contributions; or (c) Funds expended before an application is approved by the Secretary. F. Prohibition Against Use of the Project for Purposes Other Than Federally Qualified Health Center. (1) A grantee may not use a project funded by a State grant: (a) For the furtherance of sectarian religious instruction or services; (b) As a place of sectarian religious worship or instruction; (c) In connection with any program or department of divinity for any religious denomination; or (d) For any purpose other than a federally qualified health center. (2) Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant have been used, or are being used, for a purpose prohibited by the Act. #### Regulation .09 Use of Funds for Acquisition and Renovation. *COMAR 10.08.05.09* A. If the applicant is acquiring a site with existing improvements, and the existing improvements are to be renovated for or used for a federally qualified health center, the total project costs may be eligible for State participation. B. In the circumstances outlined in §A of this regulation, at least two State-approved appraisers shall provide appraisals of the site and existing improvements to be acquired. State participation shall be limited to the lesser of the appraised value approved by the Department of General Services based upon the appraisals or the actual acquisition cost. C. If an applicant proposes to acquire an unimproved land site on which to construct a facility, the cost of the land is not eligible for State participation. #### Regulation .10 Residual Requirements of the Grantee. *COMAR 10.08.05.10* A. Annual Requirements. (1) For 30 years following the completion of conversion, acquisition, renovation, capital equipping, or construction of a federally qualified health center involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material: (a) A recent certified, audited profit-and-loss statement and balance sheet for the facility; (b) The volume of service at the federally qualified health center, such as days of service rendered to clients; and (c) Other supplemental information required by the Secretary. (2) For 30 years following the completion of a project that receives poverty funding under Regulation .08D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving designated poverty-area clients. B. Insurance Requirements. (1) Upon acquisition of the project, the grantee shall provide an all-risk insurance policy that: (a) Provides coverage for an amount at least equal to the replacement cost of the facility; (b) Names the State as a loss payee; (c) Protects the State's interest in the project; and (d) Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Cancellation of policy; (ii) Material loss covered by the policy; or (iii) Material changes in the policy. (2) The grantee shall provide builders’ risk insurance coverage during the entire period of project construction or renovation up to and including the owner’s acceptance of the building that: (a) Names the State as a loss payee; (b) Protects the State's interest in the building; (c) Provides an amount at least equal to the replacement cost of the facility; and (d) Requires evidence of the coverage be submitted to the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201. (3) Upon completion of a project, the grantee shall maintain, for 30 years, an all-risk insurance policy that: (a) Provides coverage for an amount at least equal to the replacement cost of the facility; (b) Names the State as a loss payee; (c) Protects the State's interest in the project; (d) Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Cancellation of policy; (ii) Material loss covered by the policy; or (iii) Material changes in the policy. (4) The grantee shall maintain and submit evidence of this insurance annually, for a period of 30 years, to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer’s Office, Insurance Division. C. During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the Department may audit the business records of the applicant and the applicant's agents, contractors, heirs, or assigns. D. Extension of Time for Completion, and Other Changes. (1) The applicant shall notify the Secretary promptly and in any event, not later than 30 days after the applicant knew or should have reasonably have known that the applicant is unable to encumber funds: (a) In the manner approved by the Secretary; or (b) Within 2 years of the appropriation of the State Grant by the Maryland legislature. (2) For good cause the Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time. (3) Upon a demonstration of good cause for an extension of time, the Secretary may grant an extension of an additional 180 days to encumber funds. E. Expenditures. State funds may not be released until the applicant: (1) Has recorded a notice of the State's Right of Recovery, as approved by the Secretary, in the land records of the county or Baltimore City in which the property is located; and (2) Is in compliance with this chapter and all applicable federal and State laws. F. Penalties. If the grantee does not comply with this chapter and all other applicable State and federal laws, the Secretary may: (1) Refuse to consider the grantee for any future funding under the Act; (2) Require an audit of the grantee; (3) Notify the Department's Office of Health Care Quality; and (4) Take other action as appropriate. #### Regulation .11 Right of Recovery. *COMAR 10.08.05.11* In the event of default under the terms of the Act and this chapter, a federally qualified health center financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act. ### Chapter 06 — Construction Funds for Conversion of Nursing Facilities **Authority:** Health-General Article, §§24-1401—24-1408, Annotated Code of Maryland **Administrative History:** Effective date: August 13, 2007 (34:16 Md. R. 1432) #### Regulation .01 Scope. *COMAR 10.08.06.01* A. This chapter governs the administration of State grant funds for any county, municipal corporation, or nonprofit organization for the conversion of nursing facility beds to provide other health care services under the Nursing Facility Conversion Grant Program, Health-General Article, §§24-1401—24-1408, Annotated Code of Maryland. B. It is the intent of the Department that State grant funds be used: (1) To assist eligible applicants with the conversion of existing nursing facilities eligible under the Act in accordance with this chapter; and (2) After the applicant has secured all funds available from other sources. #### Regulation .02 Definitions. *COMAR 10.08.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Act” means Health-General Article, §§24-1401—24-1408, Annotated Code of Maryland, which authorizes the disbursement of State grant funds for the purposes of converting nursing facility beds to provide other health care services determined appropriate by the Department. (2) “Admission criteria” means criteria established by a facility for admitting individuals including limitations, if any. (3) “Applicant” means a county, municipal corporation, or nonprofit organization that has submitted an application. (4) “Application” means the forms required and published by the Department, and submitted by the applicant to the Office of Capital Planning, Budgeting, and Engineering Services, to apply for a State grant for a project. (5) “Board of Public Works” means the Board established by Article XII of the Constitution of Maryland, consisting of the Governor, the Treasurer, and the Comptroller of Maryland. (6) “Building” means all or part of an existing nursing facility; (7) “Capital equipment” means items that: (a) With normal maintenance, have a life expectancy of at least 15 years; (b) Have durable construction; and (c) Are necessary to furnish a new health service not previously provided by the facility. (8) “Construction” means an addition to an existing nursing facility building that results in the reduction of comprehensive care beds and therefore, the provision of other health care services. (9) “Conversion” means the work required to modify or adapt the interior arrangement and other physical characteristics of an existing nursing facility building, in order to transform the facility or part of the facility for uses as stipulated in the annual application instructions. (10) “Default” means: (a) Transfer of property to any person, agency, or organization that would not qualify as an applicant or that is not approved as a transferee by the Board of Public Works; (b) Failure to complete a project and to obtain required occupancy permit; (c) Failure to provide a new health service and commence operation within 1 year after obtaining an occupancy permit; (d) Failure to de-license a specified number of comprehensive nursing home beds; or (e) Failure to provide approved health care service upon which a grant was predicated for a period of 30 years after the completion of project. (11) “Department” means the Maryland Department of Health. (12) “Eligible person” means an individual who meets facility admission criteria. (13) “Eligible work” means that work for which the use of State funds is authorized under the Act. (14) “Facility” means: (a) A facility that meets the definition of Health-General Article, §19-1401(e), Annotated Code of Maryland; (b) A facility that is licensed by the Department; and (c) A nursing facility that is wholly owned by and operated under the authority of: (i) A county or a municipal corporation, or both; or (ii) A nonprofit nursing facility that is wholly owned by and operated under the authority of a nonprofit organization. (15) “Grant” means any funds competitively awarded from any source to the applicant including a State grant. (16) “Grantee” means a nursing facility that receives State grant funds under the Act, which are approved by the Board of Public Works. (17) “Nonprofit organization” has the meaning stated in Health-General Article, §24-1401, Annotated Code of Maryland. (18) “Office of Capital Planning, Budgeting, and Engineering Services” means the unit within the Department designated by the Secretary to administer this chapter. (19) “Operating costs” means costs associated with the operation of the new service. (20) “Other health care services” means those health care services determined appropriate by the Department as stipulated in the annual grant application instructions. (21) “Project” means the approved proposed scope of work by the Department for the renovation, construction, and equipping of a facility in order to convert existing nursing facility bed space for other health care services. (22) “Renovation” means restoration or modernization of space that results in the reduction of comprehensive care beds in an existing nursing facility. (23) “Retroactive expenditure” means any cost incurred or contracted for before the application for conversion has been received and approved by the Secretary. (24) “Secretary” means the Secretary of Health, or a designated representative. (25) “State grant” means State funds awarded under the Nursing Facility Conversion Grant Program. (26) “Wholly owned” has the meaning stated in Health-General Article, §24-1401, Annotated Code of Maryland. #### Regulation .03 Use of State Grant Funds. *COMAR 10.08.06.03* State grant funds for nursing facilities under the Act shall be used solely for projects approved by the Department for the purpose of converting existing nursing facility beds to provide: A. Other health care services; B. Purchase of capital equipment; and C. Planning, design, construction, and renovation of a facility. #### Regulation .04 Eligible Applicants for State Grant Funds. *COMAR 10.08.06.04* A. To be eligible to apply for State grant funds under the Act, an applicant shall: (1) Be a county, municipal corporation, or a nonprofit organization; (2) Have a proposed project that is in accord with the priorities of the Secretary; (3) Be licensed by the Department; (4) Be eligible for certification under, and agree to participate in, Title XVIII and Title XIX of the Social Security Act; (5) Certify that the proposed facility will meet the accessibility requirements of 42 U.S.C. 12101 et seq., or provide a certified waiver from the Department of Housing and Community Development; (6) Not have had any of the following deficiencies cited in any survey conducted by the Department's Office of Health Care Quality during the calendar year preceding the grant application year, using the scope and severity matrix found in the Centers for Medicare and Medicaid Services State Operations Manual for Survey and Certification, Part 7, §7400E: (a) Two or more “G” level deficiencies; or (b) One or more “H” or higher-level deficiencies; and (7) Be approved by the Secretary to receive a grant award. B. A provider operating a facility with any of the deficiencies described in §A(6) of this regulation may be eligible to apply for a grant if the facility has undergone a change in ownership as a result of an arm's length transaction as determined by the Department, since the latest survey that resulted in the deficiencies. #### Regulation .05 Application Procedure. *COMAR 10.08.06.05* A. An applicant shall apply for a State grant by: (1) Completing an application with the Department on a form provided by the Department; and (2) Filing the completed application for State grant funds with the Office of Capital Planning, Budgeting, and Engineering Services. B. The Department shall provide any notice and information to the State Clearinghouse for intergovernmental review that may be required under COMAR 14.24.04. C. The applicant shall comply with all applicable federal and State laws and regulations in effect at the time of application. D. At the time of filing the application, the applicant shall file a written statement with the Department containing the following information or material: (1) Current or intended program of services; (2) The number of personnel employed or to be employed at the facility, by occupation, and all perquisites, salaries, and any compensation paid, or to be paid, to the personnel; (3) Expenses incurred, or to be incurred, in carrying out qualified facility operations; (4) Schedule of rates charged, or to be charged, for services rendered at the facility; (5) Agreement to admit eligible persons on the basis of their need for services without regard to race, national origin, color, or disability; (6) A certified, audited profit-and-loss statement and balance sheet for the most current year; and (7) If the applicant is applying for poverty funding under Regulation .08D of this chapter, an agreement that the majority of the individuals served by the applicant will be poverty-designated clients, as defined in Regulation .08D(2) of this chapter, for each year for a period of 30 years following the completion of the conversion of the facility. E. The Secretary shall recommend to the Board of Public Works applications that: (1) Meet the requirements of this regulation; and (2) Set forth the priorities of the Department as stipulated in the annual application instructions. #### Regulation .06 Amount of State Grant Awards. *COMAR 10.08.06.06* The Department shall determine the amount of the State grant, if any, for an applicant's approved project after consideration of the following: A. All approved applications; B. Priorities of need as established by the Department; C. The total unallocated State funds available for grants under the Act; D. The projected amount of anticipated appropriations as provided in the Governor's Five-Year Capital Improvement Program; E. The reasonableness of the total cost of the project; and F. Current operating costs or the reasonableness of a projected budget and revenues for the facility. #### Regulation .07 Recommendation of State Grant Awards. *COMAR 10.08.06.07* A. The Department shall determine whether the application is to be recommended to the Board of Public Works for award of State grant funds after consideration of the following: (1) The availability of State grant funds; (2) The receipt of satisfactory evidence from the applicant of the following requirements: (a) Documentation from the Maryland Health Care Commission that: (i) A certificate of need is not required for a decrease in bed capacity or conversion to an alternative health care facility or service proposed by the project; or (ii) An applicant has obtained a certificate of need, if required pursuant to Health-General Article, §19-120, Annotated Code of Maryland, for the proposed changes in bed capacity or license category, or to establish the new health care facility or service; (b) Sufficient total financial contribution to complete the project; (c) Control of site, such as deed or lease; (d) Compliance with applicable local zoning requirements; (e) Certified bid tabulation, construction contract; and (f) Compliance with all other applicable provisions of State or federal law. B. Upon satisfactory completion of §A of this regulation, the Secretary shall recommend to the Board of Public Works that a State grant be made to the approved applicant, together with a written report stating that: (1) A notice, including information in the application, has been provided to the State Clearinghouse; (2) The application has been approved by the Secretary; and (3) The amount of a federal grant, if any is involved, that has been awarded to the applicant. #### Regulation .08 Grant Limitations and Provisions. *COMAR 10.08.06.08* A. Use of Federal Grants. (1) Any federal grant that is received for an eligible project shall be applied first to the cost of the project. (2) Community development block grants are considered as local matching funds and are not considered as federal grant funds. (3) All other sources of funds shall be expended before any or all of the State grant is expended on an approved project. B. Limits of State Grant. (1) Except as provided in §D of this regulation, a State grant may not exceed 50 percent of the cost of eligible work remaining unpaid after all federal grants have been applied. (2) A State grant may not be used to fund participation in retroactive expenditures. (3) A State grant may include only those costs incurred or obligations contracted for eligible work after the application has been approved by the Secretary. (4) State grant funds may not be used to pay the following costs: (a) Noncapital equipment; (b) Consultant services; or (c) Off-site improvements. C. Exceptions on State Grant Limits. A project designated as eligible for poverty area funding under §D of this regulation may receive a State grant to cover up to 75 percent of the cost of eligible work remaining unpaid after all federal grants have been applied. D. Poverty Area Funding. An applicant is eligible for poverty area funding for a facility if: (1) The project is designated as eligible for poverty area funding under applicable federal regulations and State plans or Departmental regulations; and (2) The majority of individuals served by the facility: (a) Are certified by a local department of social services as eligible for General Public Assistance or Medical Assistance; (b) Are eligible for Supplemental Security Income benefits; or (c) Have income levels which do not exceed 150 percent of the federal poverty level. E. Funding Contribution Requirements. (1) The grantee shall provide, from other sources, funds equal to the total cost of the eligible project less the State grant award. (2) The grantee shall assume the risk of all costs associated with the project that are incurred before the date of approval of a State grant award by the Board of Public Works. (3) A grantee may not expend the State grant award before other sources of funds are expended. (4) The Department may not consider as contributions: (a) Real or personal property; (b) In-kind contributions; or (c) Funds expended before an application is approved by the Secretary. (5) A grantee may not use a project funded by a State grant primarily: (a) For the furtherance of sectarian religious instruction or services; (b) As a place of sectarian religious worship or instruction; (c) In connection with any program or department of divinity for any religious denomination. (6) Upon the request of the Board of Public Works, the grantee shall submit evidence satisfactory to the Board that none of the proceeds of the grant have been, or are being, used for a purpose prohibited by the Act. #### Regulation .09 Residual Requirements of the Grantee. *COMAR 10.08.06.09* A. Annual Requirements. (1) For a period of 30 years following the conversion of nursing facility beds involving the State grant funds in this chapter, a grantee shall file a written statement annually with the Department containing the following material: (a) A recent certified, audited profit-and-loss statement and balance sheet for the facility; (b) Volume of service in the portion of the building converted with State grant funds, such as days of service rendered to clients; and (c) Other supplemental information required by the Secretary. (2) For a period of 30 years following the completion of a project that receives poverty funding under Regulation .08D of this chapter, the grantee shall submit annually a quantitative statement of its performance in serving designated poverty-area clients. B. Insurance Requirements. (1) Upon acquisition of the project, the grantee shall provide an all-risk insurance policy that: (a) Provides coverage for an amount at least equal to the replacement cost of the facility; (b) Names the State as a loss payee; (c) Protects the State's interest in the project; and (d) Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Cancellation of policy; (ii) Material loss covered by the policy; or (iii) Material changes in the policy. (2) The grantee shall provide builders' risk insurance coverage during the entire period of project construction or renovation up to and including owner's acceptance of building that: (a) Names the State as a loss payee; (b) Protects the State's interest in the building; (c) Provides an amount at least equal to the replacement cost of the facility; and (d) Requires evidence of the coverage be submitted to the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201. (3) Upon completion of a project, the grantee shall maintain, for a period of 30 years, an all-risk insurance policy that: (a) Provides coverage for an amount at least equal to the replacement cost of the facility; (b) Names the State as a loss payee; (c) Protects the State's interest in the project; (d) Requires notification of the Office of Capital Planning, Budgeting, and Engineering Services, 201 West Preston Street, Baltimore, Maryland 21201 of any: (i) Cancellation of policy; (ii) Material loss covered by the policy; or (iii) Material changes in the policy. (4) The grantee shall maintain and submit evidence of this insurance annually, for a period of 30 years, to the Office of Capital Planning, Budgeting, and Engineering Services and to the State Treasurer's Office, Insurance Division. C. During the entire period of work on the project and for a period of 30 years after the project has been completed or acquired, the Department may audit the business records of the applicant and the applicant's agents, contractors, heirs, or assigns. D. Extension of Time for Completion; Other Changes. (1) The applicant shall notify the Secretary promptly and, in any event, not more than 30 days after the applicant knew or should reasonably have known that the applicant is unable to encumber funds: (a) In the manner approved by the Secretary; or (b) Within 2 years of the appropriation by the Maryland General Assembly. (2) For good cause, the Secretary may grant a request by the applicant for a change in the manner or time for encumbrance of funds, including an extension of time. (3) Upon a demonstration of good cause for an extension of time, the Secretary may grant an extension of up to an additional 180 days to encumber funds. E. Expenditures. State funds may not be released until: (1) The applicant has recorded a notice of the State's right of recovery, as approved by the Secretary, in the land records of Baltimore City or the county in which the property is located; and (2) The applicant is in compliance with this chapter and all applicable federal and State laws. F. Penalties. If the grantee does not comply with this chapter and all other applicable State and federal laws, the Secretary may: (1) Refuse to consider the grantee for any future funding under the Act; (2) Require an audit of the grantee; (3) Notify the Department's Office of Health Care Quality; and (4) Take other action as appropriate. #### Regulation .10 Right of Recovery. *COMAR 10.08.06.10* In the event of default under the terms of the Act and this chapter, a nursing facility financed pursuant to this chapter is subject to the State's right of recovery as set forth in the Act. ## Subtitle 09 — Medical Care Programs ### Chapter 01 — Advanced Practice Nurse Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland **Administrative History of COMAR 10.09.01 Eligibility:** Note: For the current Medical Assistance Eligibility regulations, see COMAR 10.09.24 and 10.09.25. **Administrative History of COMAR 10.09.01 Eligibility:** Effective date: May 1, 1975 (2:7 Md. R. 525) **Administrative History of COMAR 10.09.01 Eligibility:** Amended effective January 7, 1976 (3:1 Md. R. 41) and March 17, 1976 (3:6 Md. R. 358); amended as an emergency provision effective November 23, 1976 (3:26 Md. R. 1535) **Administrative History of COMAR 10.09.01 Eligibility:** Chapter revised effective April 27, 1977 (4:9 Md. R. 714) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .01CCC adopted effective November 23, 1977 (4:24 Md. R. 1805) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .02A amended as an emergency provision effective July 1, 1977 (4:13 Md. R. 1026); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .02A amended effective April 4, 1980 (7:7 Md. R. 707) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .02B amended effective November 23, 1977 (4:24 Md. R. 1805) **Administrative History of COMAR 10.09.01 Eligibility:** Regulations .04B, C and .05B amended effective October 3, 1980 (7:20 Md. R. 1878) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .05C amended as an emergency provision effective July 1, 1977 (4:12 Md. R. 945); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545); amended as an emergency provision effective November 10, 1977 (4:25 Md. R. 1910); adopted permanently effective March 10, 1978 (5:5 Md. R. 325) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .05C repealed effective October 3, 1980 (7:20 Md. R. 1878) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .06B amended as an emergency provision effective January 1, 1978 (5:1 Md. R. 14); adopted permanently effective May 5, 1978 (5:9 Md. R. 683) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .06B amended effective July 1, 1978 (5:13 Md. R. 1051) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .06B amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1202); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .06B amended effective July 1, 1980 (7:13 Md. R. 1278) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .06B amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1346); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .08A amended effective December 26, 1980 (7:26 Md. R. 2422) **Administrative History of COMAR 10.09.01 Eligibility:** Regulations .09 and .10B amended as an emergency provision effective August 15, 1977 (4:16 Md. R. 1205); adopted permanently effective November 23, 1977 (4:24 Md. R. 1805) **Administrative History of COMAR 10.09.01 Eligibility:** Regulations .10B and .11B amended effective December 28, 1979 (6:26 Md. R. 2073) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .10D repealed effective August 8, 1980 (7:16 Md. R. 1594) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .10D adopted as an emergency provision effective November 1, 1982 (8:21 Md. R. 1703); adopted permanently effective March 1, 1982 (9:4 Md. R. 331) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .11D amended as an emergency provision effective July 1, 1977 (4:12 Md. R. 945); adopted permanently effective September 23, 1977 (4:20 Md. R. 1545); amended as an emergency provision effective August 15, 1977 (4:16 Md. R. 1205); adopted permanently effective November 23, 1977 (4:24 Md. R. 1805); amended effective December 1, 1978 (5:24 Md. R. 1797); amended effective December 28, 1979 (6:26 Md. R. 2073) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .12A amended as an emergency provision effective January 1, 1983 (10:3 Md. R. 207); emergency status extended at 10:8 Md. R. 720; emergency status expired April 30, 1983 **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .16C amended effective October 3, 1980 (7:20 Md. R. 1878) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .17 adopted effective February 14, 1983 (10:3 Md. R. 209) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .18A amended effective January 31, 1983 (10:2 Md. R. 109) **Administrative History of COMAR 10.09.01 Eligibility:** Regulation .18B adopted as an emergency provision effective July 26, 1982 (9:17 Md. R. 1696); emergency status extended at 9:23 Md. R. 2254; adopted permanently effective November 30, 1982 (9:23 Md. R. 2259) **Administrative History of COMAR 10.09.01 Eligibility:** Chapter repealed effective May 1, 1983 (10:6 Md. R. 558) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Effective date: May 14, 1990 (17:9 Md. R. 1090) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .01 amended effective May 31, 1999 (26:11 Md. R. 854) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .02C amended effective May 31, 1999 (26:11 Md. R. 854) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .05G, Q amended effective May 31, 1999 (26:11 Md. R. 854) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .06 amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .06 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .06C,D,G amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .06E amended effective May 31, 1999 (26:11 Md. R. 854) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .06F amended effective April 4, 2011 (38:7 Md. R. 430) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .06K adopted effective May 31, 1999 (26:11 Md. R. 854) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulations .01—.10 under Nurse Practitioner Services repealed and new Regulations .01—.08 under Advanced Practice Nurse Services adopted effective August 28, 2017 (44:17 Md. R. 834) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .03 amended effective August 21, 2023 (50:16 Md. R. 725) **Administrative History of COMAR 10.09.01 Advanced Practice Nurse Services:** Regulation .06H, I amended effective August 21, 2023 (50:16 Md. R. 725) #### Regulation .01 Definitions. *COMAR 10.09.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advanced practice nurse” means a: (a) Certified nurse practitioner; (b) Certified nurse midwife; or (c) Certified registered nurse anesthetist. (2) “Board” means the Maryland State Board of Nursing. (3) “Certified nurse midwife (CNM)” means a registered nurse who is: (a) Certified by the Board to practice nurse midwifery under COMAR 10.27.05; (b) Certified by the American College of Nurse-Midwives; or (c) Certified by the American Midwifery Certification Board. (4) “Certified nurse practitioner” means: (a) A registered nurse who, by reason of certification under COMAR 10.27.07, may practice in Maryland as a nurse practitioner under the terms of that chapter; or (b) If out-of-State, a registered nurse who qualifies as a nurse practitioner in the state in which services are provided. (5) “Certified registered nurse anesthetist (CRNA)” means a registered nurse who is certified to practice nurse anesthesia by the Board under COMAR 10.27.06. (6) “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01. (7) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (8) “Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits. (9) “Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02. (10) “Program” means the Maryland Medical Assistance Program. (11) “Provider” means an advanced practice nurse who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. #### Regulation .02 License and Certification Requirements. *COMAR 10.09.01.02* A. The provider shall: (1) Meet all license requirements as set forth in COMAR 10.09.36.02; and (2) Be licensed and hold all certifications as required by the Board. B. If practicing out-of-State, the provider shall meet the regulatory requirements of the state in which the services are provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.01.03* To participate in the Program, a provider shall: A. Meet all conditions for participation as set forth in COMAR 10.09.36.03; and B. If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. #### Regulation .04 Covered Services. *COMAR 10.09.01.04* A. Subject to §B of this regulation, the Program covers medically necessary services rendered to participants as follows: (1) For nurse practitioners: (a) Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.07; or (b) If out-of-State, nurse practitioner services authorized in the state in which the services are provided; (2) For nurse midwives: (a) Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.05; or (b) If out-of-State, nurse midwife services authorized in the state in which the services are provided; (3) For certified registered nurse anesthetists: (a) Medically necessary services within the provider’s scope of practice and in collaboration with an authorized provider as described in COMAR 10.27.06; or (b) If out-of-State, certified registered nurse anesthetist services authorized in the state in which the services are provided; (4) Laboratory services when the advanced practice nurse is not required to register their office as a medical laboratory pursuant to Health-General Article, Title 17, Subtitle 2, Annotated Code of Maryland; and (5) Drugs and supplies within the advanced practice nurse’s scope of practice. B. The services in §A of this regulation shall be: (1) Medically necessary; and (2) Described in the participant’s medical record in sufficient detail to support the invoice submitted for those services. #### Regulation .05 Limitations. *COMAR 10.09.01.05* Under this chapter, the Program does not cover the following: A. Services not medically necessary; B. Services prohibited by the Maryland Nurse Practice Act or by the Board; C. Advanced practice nursing services included as part of the cost of: (1) An inpatient facility; (2) A hospital outpatient department; or (3) A freestanding clinic; D. Visits by or to the provider solely for the purpose of the following: (1) Prescription, drug, or food supplement pick-up; (2) Recording of an electrocardiogram; (3) Ascertaining the patient’s weight; (4) Interpretation of laboratory tests or panels; or (5) Prescribing or administering medication; E. Drugs and supplies which are acquired by the provider at no cost; F. Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take oral medications are documented in the patient's medical record; G. Services paid under the free-standing dialysis program as described in COMAR 10.09.22; H. Immunizations required for travel outside the continental United States; I. Prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control; J. Acupuncture; K. Hypnosis; L. Travel expenses; M. Investigational or experimental drugs and procedures; N. Services denied by Medicare as not medically justified; O. Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service; P. Laboratory or X-ray services performed by another facility, which shall be billed to the Program directly by the facility; and Q. For certified nurse midwives, a separate visit charge on date of delivery. #### Regulation .06 Payment Procedures. *COMAR 10.09.01.06* A. The provider shall submit the request for payment in the format designated by the Department. B. The Department reserves the right to return to the provider, before payment, all requests for payment not properly completed. C. The provider shall charge the Program the provider's: (1) Customary charge to the general public for similar services; and (2) Acquisition cost for injectable drugs or dispensed medical supplies. D. The provider shall be paid the lesser of: (1) The provider's customary charge to the general public unless the service is free to individuals not covered by the Program; or (2) The Program rates as described in COMAR 10.09.02.07. E. If a service is free to individuals not covered by the Program: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §D of this regulation; and (2) The provider's reimbursement is not limited to the provider's customary charge. F. Payments on Medicare claims are authorized, if: (1) Services are covered by the Program; (2) The provider accepts Medicare assignments; (3) Medicare makes direct payment to the provider; (4) Medicare has determined that services were medically justified; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. G. The Department shall make supplemental payments on Medicare claims subject to the following provisions: (1) Deductible insurance shall be paid in full; and (2) Coinsurance shall be paid at the lesser of: (a) 100 percent of the coinsurance amount; or (b) The balance remaining after the Medicare payment is subtracted from the Program rate. H. The provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; or (3) Professional services rendered by mail. I. The Program may not make direct payment to participants. J. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. K. The Program shall reimburse for all medical laboratory services according to the fees established under COMAR 10.09.09. L. An advanced practice nurse who is employed by or under contract to any physician, clinic, or hospital may not bill for any service for which reimbursement is sought by the physician, clinic, or hospital. M. The Program may not reimburse nurse midwives for prenatal or postpartum care once the patient has been referred to a physician for completion of prenatal or postpartum care. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.01.07* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .08 Causes for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.01.08* Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. ### Chapter 02 — Physicians' Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1967 **Administrative History:** Amended effective September 1, 1967; October 1, 1967; January 1, 1969; July 1, 1969; December 1, 1969; July 1, 1970; July 1, 1971; January 1, 1976 (2:29 Md. R. 1739) **Administrative History:** Regulation .22 adopted effective October 13, 1976 (3:21 Md. R. 1206); recodified as Regulation .11 on December 8, 1976 (3:25 Md. R. 1467) **Administrative History:** Existing regulations repealed and new Regulations .01—.10 adopted effective December 8, 1976 (3:25 Md. R. 1467) **Administrative History:** Regulation .02C amended effective December 15, 1978 (5:25 Md. R. 1854) **Administrative History:** Regulation .04D amended effective December 15, 1978 (5:25 Md. R. 1854) **Administrative History:** Regulation .04K, L adopted effective January 13, 1978 (5:1 Md. R. 18) **Administrative History:** Regulation .04K amended effective July 1, 1978 (5:12 Md. R. 967) **Administrative History:** Regulation .04L repealed effective July 1, 1978 (5:12 Md. R. 967) **Administrative History:** Regulation .05F adopted effective December 15, 1978 (5:25 Md. R. 1854) **Administrative History:** Regulation .07 amended effective December 15, 1978 (5:25 Md. R. 1854) **Administrative History:** Regulation .07G amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) **Administrative History:** Regulation .07I amended effective April 6, 1979 (6:7 Md. R. 676); repealed effective July 1, 1979 (6:13 Md. R. 1126) **Administrative History:** Regulation .07N amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .11 repealed effective June 29, 1979 (6:13 Md. R. 1126) **Administrative History:** Regulations .01—.08 amended effective July 1, 1979 (6:13 Md. R. 1126) **Administrative History:** Regulation .01 amended effective December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulation .01A-1, A-2, A-3, N-2 adopted effective October 1, 1985 (12:19 Md. R. 1848) **Administrative History:** Regulation .01B amended effective October 15, 1990 (17:20 Md. R. 2426); December 29, 1997 (24:26 Md. R. 1757); March 6, 2000 (27:4 Md. R. 453) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulations .01B, .03B, .06, and .07Q amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1286) (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .01B amended effective July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .01J-1 adopted effective August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .01N-1 adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721) **Administrative History:** Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .03 amended effective July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .03A amended effective October 1, 1985 (12:19 Md. R. 1848) **Administrative History:** Regulation .03B adopted effective December 29, 1997 (24:26 Md. R. 1757) **Administrative History:** Regulation .03B amended effective March 6, 2000 (27:4 Md. R. 453); August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Regulation .03G amended effective October 1, 1985 (12:19 Md. R. 1848); December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572) **Administrative History:** Regulation .03I—K amended effective December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulation .03J adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .03K adopted effective October 1, 1985 (12:19 Md. R. 1848) **Administrative History:** Regulation .03 amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) **Administrative History:** Regulation .03O adopted effective October 15, 1990 (17:20 Md. R. 2426) **Administrative History:** Regulation .04 amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183) **Administrative History:** Regulation .04 amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221) **Administrative History:** Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453) **Administrative History:** Regulation .04 amended effective December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .04A amended effective August 17, 1981 (8:16 Md. R. 1365); December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulation .04A amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) **Administrative History:** Regulation .04A amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443) **Administrative History:** Regulation .04A amended effective February 3, 2014 (41:2 Md. R. 91); August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Regulation .04C amended effective December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulation .04G amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1202); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) (adopted as Regulation .04K; recodified as Regulation .04G at 6:13 Md. R. 1126) **Administrative History:** Regulation .04G amended as an emergency provision effective July 28, 1980 (7:16 Md. R. 1588); adopted permanently effective November 28, 1980 (7:24 Md. R. 2257) **Administrative History:** Regulation .04G amended effective December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulation .04J adopted effective October 1, 1985 (12:19 Md. R. 1848) **Administrative History:** Regulation .05A amended effective August 12, 1985 (12:16 Md. R. 1606); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2902); December 16, 1996 (23:25 Md. R. 1785); March 6, 2000 (27:4 Md. R. 453); February 5, 2001 (28:2 Md. R. 99) **Administrative History:** Regulation .05A amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .05A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .05A amended effective June 23, 2014 (41:12 Md. R. 667); December 10, 2015 (42:24 Md. R. 1505); July 10, 2023 (50:13 Md. R. 512); June 24, 2024 (51:12 Md. R. 618) **Administrative History:** Regulation .05D amended effective December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulations .05G and .06A adopted as an emergency provision effective January 1, 1981 (7:26 Md. R. 2412); adopted permanently effective May 2, 1981 (8:8 Md. R. 721) **Administrative History:** Regulation .05H adopted effective October 15, 1990 (17:20 Md. R. 2426) **Administrative History:** Regulation .05H repealed effective March 6, 2000 (27:4 Md. R. 453) **Administrative History:** Regulation .05H adopted as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); adopted permanently effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .05I adopted effective July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .06A amended effective June 20, 1983 (10:12 Md. R. 1072); February 9, 1987 (14:3 Md. R. 273); December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757) **Administrative History:** Regulation .06A amended effective October 10, 2016 (43:20 Md. R. 1109) **Administrative History:** Regulation .06A, D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .06E adopted effective April 4, 1980 (7:7 Md. R. 708) **Administrative History:** Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Regulation .06F adopted effective December 29, 1997 (24:26 Md. R. 1757) **Administrative History:** Regulation .07 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .07 amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1467); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) **Administrative History:** Regulation .07 amended effective March 6, 2000 (27:4 Md. R. 453) **Administrative History:** Regulation .07 amended as an emergency provision effective December 18, 2003 (31:2 Md. R. 81); amended permanently effective April 26, 2004 (31:8 Md. R. 646) **Administrative History:** Regulation .07 amended effective June 14, 2021 (48:12 Md. R. 470); July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .07C amended effective December 16, 1996 (23:25 Md. R. 1785) **Administrative History:** Regulation .07C, E, I amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); amended permanently effective November 1, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .07D amended effective December 6, 1982 (9:24 Md. R. 2390); May 1, 1983 (10:8 Md. R. 725); November 21, 1983 (10:23 Md. R. 2063) **Administrative History:** Regulation .07D amended as an emergency provision effective January 27, 1984 (11:4 Md. R. 312); emergency status expired May 26, 1984 **Administrative History:** Regulation .07D amended effective May 27, 1984 (11:10 Md. R. 863) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811) **Administrative History:** Regulation .07D amended effective March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542) **Administrative History:** Regulation .07D amended as an emergency provision effective March 1, 1986 (13:6 Md. R. 668); emergency status expired June 30, 1986 **Administrative History:** Regulation .07D amended effective June 2, 1986 (13:11 Md. R. 1273); **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1986 (13:12 Md. R. 1371); amended permanently effective December 1, 1986 (13:18 Md. R. 2020) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); amended permanently effective October 6, 1986 (13:20 Md. R. 2210) **Administrative History:** Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987 **Administrative History:** Regulation .07D amended effective December 1, 1986 (13:22 Md. R. 2398) **Administrative History:** Regulation .07D repealed and new Regulation .07D adopted effective February 9, 1987 (14:3 Md. R. 273); amended effective October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903); January 1, 1989 (15:26 Md. R. 2983); July 1, 1989 (16:12 Md. R. 1335) **Administrative History:** Regulation .07D amended as an emergency provision effective September 8, 1989 (16:20 Md. R. 2178); adopted permanently effective January 1, 1990 (16:25 Md. R. 2710) **Administrative History:** Regulation .07D amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulation .07D amended effective December 9, 1991 (18:24 Md. R. 2643) **Administrative History:** Regulation .07D amended as an emergency provision effective October 26, 1993 (20:23 Md. R. 1799); emergency status extended at 20:24 Md. R. 1863 and 21:11 Md. R. 949; emergency status expired July 4, 1994 **Administrative History:** Regulation .07D amended effective July 4, 1994 (21:13 Md. R. 1156) **Administrative History:** Regulation .07D amended as an emergency provision effective December 1, 1994 (21:26 Md. R. 2183); emergency status expired April 30, 1995 **Administrative History:** Regulation .07D amended as an emergency provision effective February 3, 1995 (22:4 Md. R. 231); emergency status expired May 31, 1995; adopted permanently effective August 14, 1995 (22:16 Md. R. 1221) **Administrative History:** Regulation .07D amended effective December 16, 1996 (23:25 Md. R. 1785); December 29, 1997 (24:26 Md. R. 1757) **Administrative History:** Regulation .07D amended effective February 5, 2001 (28:2 Md. R. 99) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 16, 2002 (29:18 Md. R. 1443) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2005 (32:17 Md. R. 1437); amended permanently effective October 24, 2005 (32:21 Md. R. 1707) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1273); amended permanently effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .07D amended effective November 16, 2009 (36:23 Md. R. 1817); November 14, 2011 (38:23 Md. R. 1421); October 28, 2013 (40:21 Md. R. 1775); December 22, 2014 (41:25 Md. R. 1478); February 27, 2017 (44:4 Md. R. 252); August 28, 2017 (44:17 Md. R. 834); August 27, 2018 (45:17 Md. R. 803); December 31, 2018 (45:26 Md. R. 1241); October 7, 2019 (46:20 Md. R. 844); June 24, 2024 (51:12 Md. R. 618); June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430) **Administrative History:** Regulation .07J, M, N amended effective December 12, 1988 (15:25 Md. R. 2902) **Administrative History:** Regulation .07O amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07O amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07Q amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) **Administrative History:** Regulation .07Q amended effective December 29, 1997 (24:26 Md. R. 1757) **Administrative History:** Regulation .07R adopted effective October 1, 1985 (12:19 Md. R. 1848) **Administrative History:** Regulation .07S adopted effective December 16, 1996 (23:25 Md. R. 1785) **Administrative History:** Regulation .08 amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .08A amended effective December 12, 1988 (15:25 Md. R. 2902); July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .09A, B amended effective March 1, 1982 (9:4 Md. R. 331) **Administrative History:** Regulation .09E amended effective December 12, 1988 (15:25 Md. R. 2902): July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .09F adopted effective October 1, 1985 (12:19 Md. R. 1848) **Administrative History:** Regulation .09F amended effective July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .11 amended effective July 10, 2023 (50:13 Md. R. 512) #### Regulation .01 Definitions. *COMAR 10.09.02.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Attending physician” means a physician, other than a house officer, resident, intern, or emergency room physician, directly responsible for the patient's care. (2) “Board” means the Board of Physician quality Assurance. (3) “Consultant-specialist” means a licensed physician who meets one of the following criteria: (a) Has been declared board certified by a member board of the American Board of Medical Specialties and currently retains that status; (b) Can demonstrate satisfactory completion of a residency program accredited by the Liaison Committee for Graduate Medical Education, or the appropriate Residency Review Committee of the American Medical Association; (c) Has been declared board certified by a specialty board approved by the Advisory Board of Osteopathic Specialists and the Board of Trustees of the American Osteopathic Association; (d) Has been declared board eligible by a specialty board approved by the Advisory Board of Osteopathic Specialists; (e) Can demonstrate, if a residency program was completed in a foreign country, that qualifications and training are acceptable for admission into the examination system of the appropriate American Specialty Board. (4) “Consultation” means written opinion or advice rendered by a consultant-specialist whose opinion or advice is requested by the patient's attending physician for the further evaluation or management of the patient by the attending physician. If the consultant-specialist assumes responsibility for the continuing care of the patient, a subsequent service rendered by the consultant-specialist is not a consultation. The consultation shall be provided in the specialty in which the consultant-specialist is registered with the Program. (5) “Cosmetic surgery” means surgery which can be expected to improve a patient's physical appearance, but does not restore or materially improve a body function. (6) “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (7) “Direct supervision” means that a physician-employer is physically present in the same area of a facility as a nonphysician providing the service or services. A physician may supervise only two nonphysician practitioners at any given time. (8) “Free-standing clinics” means those clinics not associated with a hospital which are under the direction of a physician or dentist. (9) “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. (10) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (11) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (12) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (13) “Medicare-Certified Facility” means one which is certified for Medicare by the regional office of the Health Care Financing Administration to furnish dialysis services directly to chronic kidney disease patients. (14) “Mental health services” means those services described in COMAR 10.09.70.10C rendered to treat an individual for a diagnosis set forth in COMAR 10.09.70.10A. (15) “Multispecialty setting” means that type of medical practice which exists in a teaching hospital or in a group practice which is composed of physicians with different specialties. (16) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (17) “Patient” means a recipient awaiting or undergoing health care or treatment. (18) “Physician” means an individual legally licensed to practice medicine by the Board or in the state in which the physician's practice is located. (19) “Preauthorization” means an approval required from the Department or its designee before services can be rendered. (20) “Preoperative day” means an inpatient day in a general hospital before surgery for a patient admitted for a surgical procedure, or a day before surgery for a patient admitted for a nonsurgical service as an inpatient in a general hospital once the need for surgery has been established and the patient's condition is satisfactory for surgery. (21) “Prescriber” means a physician, dentist, podiatrist, or other professional authorized to prescribe legend drugs and authorized by the Department to participate in the Program. (22) “Prescription” means a written order for medication, or medical supplies or equipment, signed by the prescriber. (23) “Program” means the Maryland Medical Assistance Program. (24) “Provider” means an individual, association, partnership, or incorporated or unincorporated group of physicians duly licensed or certified to provide services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. (25) “Referral” means a transfer of the patient from one physician to another for diagnosis and treatment of the condition for which the referral was made. The physician to whom the referral is made, whether a generalist or specialist, will be considered as the primary care physician and not as a consultant. (26) “United States” means the 50 states, the District of Columbia, and the U.S. territories. (27) “Utilization control agent (UCA)” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to professional standards. #### Regulation .02 License Requirements. *COMAR 10.09.02.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided. C. The provider shall ensure that all X-ray or other radiological equipment is inspected and meets the standards established by COMAR 10.14.02 or other applicable standards established by the state in which the service is provided. D. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.02.03* A. General requirements for participation in the Program are that a provider shall: (1) Meet all the conditions for participation as set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. Specific requirements for participation in the Program as a physicians’ services provider require that the provider: (1) Shall submit documentation of consultant-specialist status if applying for that status; (2) May not place a restriction on a participant’s right to select providers of his or her choice; (3) May not knowingly employ or contract with a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance participants unless prior written approval has been received from the Department; (4) Shall agree to personally sign all requests for laboratory or other diagnostic services, or to require that copies of personally signed order sheets be supplied to participating providers of these services; (5) Shall agree, when requesting laboratory or other diagnostic services, to supply his or her individual practitioner identification (rendering) number to those participating providers; (6) Shall agree to identify by the individual physician practitioner's identification number each physician assistant who is authorized by the physician to request laboratory services; and (7) Shall comply with the requirements for the delivery of mental health services in accordance with COMAR 10.09.59 and 10.67.08. #### Regulation .04 Covered Services. *COMAR 10.09.02.04* The Program covers the following medically necessary services rendered to participants: A. Physicians’ services rendered in the physician’s office, the participant’s home, a hospital, a skilled or intermediate care nursing facility, a freestanding clinic, or elsewhere when these services are: (1) Performed by the physician or one of the following: (a) Another licensed physician either in the physician's employ or one who renders services through a reciprocal agreement as a substitute physician, (b) A certified registered physician's assistant, licensed registered nurse, certified psychologist, or a certified social worker, provided that the individual performing the service is in the physician's employ and is under the physician's direct supervision and performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of physicians' services, (c) A certified nurse midwife who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.05; and (d) A certified nurse practitioner who performs medically necessary services within the provider's scope of practice as described in COMAR 10.27.07. (2) Clearly related to the participant’s individual medical needs as diagnostic, curative, palliative, or rehabilitative services; (3) Adequately described in the participant’s medical record; B. Consultations; C. Diagnostic procedures to include: (1) Procedures related to the patient's medical needs; (2) Laboratory services performed by a physician or personnel under the physician's direct supervision, when the physician is not required to register his office as a medical laboratory pursuant to Health-General Article, Title 17, Subtitle 2, Annotated Code of Maryland; D. Drugs dispensed by the physician within the limitations of COMAR 10.09.03; E. Injectable drugs administered by the provider within the limitations of COMAR 10.09.03; F. Medical equipment and supplies dispensed by the physician within the limitations of COMAR 10.09.12; G. Abortions performed in accordance with the Health-General Article, Title 20, Subtitles 1 and 2, Annotated Code of Maryland; H. Sterilizations when performed according to criteria contained in 42 Code of Federal Regulations §§441.250—441.258 and when the appropriate forms, as established by guideline, are properly completed and attached to the claim; I. Vaccine administrations when the vaccines: (1) Meet the following conditions for coverage under the Vaccines for Children Program: (a) Covered under the Vaccines for Children program; (b) Administered to participants eligible for the Vaccines for Children program; and (c) Administered by providers eligible to be reimbursed for vaccine administration under the Vaccines for Children program; or (2) Are supplied to providers by the federal government at no charge, including but not limited to the administration of COVID-19 vaccinations. #### Regulation .05 Limitations. *COMAR 10.09.02.05* A. Services which are not covered are: (1) Physician services not medically justified; (2) Nonemergency dialysis services related to chronic kidney disorders unless they are provided in a Medicare-certified facility; (3) Physician inpatient hospital services rendered during any period that is in excess of the length of stay authorized by the Utilization control agent (UCA); (4) Physician services denied by Medicare as not medically necessary; (5) Services which are investigational or experimental; (6) Autopsies; (7) Physician services included as part of the cost of an inpatient facility, hospital outpatient department, or free-standing clinics; (8) Payment to physicians for specimen collections, except by venipuncture, and capillary or arterial puncture; (9) Injectable medications, and visits solely for the administration of injectable medications, unless medical necessity and the patient’s inability to take appropriate oral medications are documented in the patient’s medical records; (10) Vaccine administration unless covered under Regulation .04 of this chapter; (11) Visits solely to accomplish one or more of the following: (a) Prescription, drug or food supplement pick-up, collection of specimens for laboratory procedures, (b) Recording of an electrocardiogram, (c) Ascertaining the patient's weight; (12) Interpretation of laboratory tests or panels; (13) Medical Assistance prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control; (14) Drugs and supplies dispensed by the physician which are acquired by the physician at no cost; (15) Disposable medical supplies; (16) Services prohibited by the Board of Physician Quality Assurance; (17) Services which are provided outside the United States; (18) Services which do not involve direct patient contact; (19) Sterilization reversal procedures; (20) Prescriptions for drugs written on prescription pads that do not prevent copying, modification, or counterfeiting; (21) Physician-administered drugs from manufacturers that do not participate in the Federal Drug Rebate Program; and (22) Any covered service that requires a preauthorization, including physician-administered drugs and injectable medications, that is rendered without an approved preauthorization from the Program. B. Preoperative evaluations for anesthesia are included in the fee for administration of anesthesia and the provider may not bill them as consultations. C. Referrals from one physician to another for treatment of specific patient problems may not be billed as consultations. D. The operating surgeon may not bill for the administration of anesthesia or for an assistant surgeon who is not in the operating surgeon's employ. E. Payment for consultations provided in a multispecialty setting is limited by criteria established by the Department. F. The Department will not pay a provider for those laboratory or x-ray services performed by another facility. The Department will pay directly the facility performing those services. G. The Program does not cover services rendered to an inpatient before one preoperative inpatient day, unless preauthorized by the Program. H. The provider may not bill the Program for services rendered under the supervising physician's provider number by an employed nonphysician extender, such as: (1) A physical therapist; (2) An occupational therapist; (3) A speech language pathologist; (4) An audiologist; or (5) A nutritionist. I. Services not rendered in-person shall comply with the telehealth requirements established in COMAR 10.09.49 and any other subregulatory guidance issued by the Department. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.02.06* A. The following procedures or services require preauthorization: (1) Cosmetic surgery; (2) Contact lens evaluation and fitting; (3) Lipectomy and panniculectomy; (4) Transplantations of vital organs; (5) Services rendered to an inpatient before one preoperative day; (6) Surgical procedures for the treatment of obesity; (7) Surgical procedures for the purpose of gender reassignment; and (8) Elective services from a noncontiguous state. B. Services which have been determined by Medicare to be ineffective, unsafe, or without proven clinical value are generally presumed to be not medically necessary, but will be preauthorized if the provider can satisfactorily document medical necessity in a particular case. These services are found in the Medicare Carriers Manual, Part 3, Claims Process, Chapter II, Coverage Issues Appendix. C. Physicians dispensing or prescribing eyeglasses shall comply with the requirements of COMAR 10.09.14. D. The Department will preauthorize services when the provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. E. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. Non-Medicare claims require preauthorization according to §§A—D of this regulation. F. Physicians rendering mental health services shall comply with the preauthorization requirements of COMAR 10.09.70.07. #### Regulation .07 Payment Procedures. *COMAR 10.09.02.07* A. The provider shall submit the request for payment on the form designated by the Department. B. The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department. C. Except as provided in §F of this regulation, the Provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §D of this regulation; and (2) The provider's reimbursement is not limited to the provider's customary charge. D. The Maryland Medical Assistance Program's procedures for payment are contained in the following documents, the provisions of which are incorporated by reference: (1) The Professional Services Provider Manual and Fee Schedule (Effective January 2024); and (2) The Medical Laboratories Fee Schedule pursuant to COMAR 10.09.09.07D. E. Except as provided in §F of this regulation, the Department will pay for covered services at the lesser of: (1) Physician's customary charge or acquisition cost unless the service is free to individuals not covered by Medicaid; or (2) The Department's fees in accordance with §D of this regulation. F. The Program shall reimburse providers up to the acquisition cost for diagnostic and therapeutic radiopharmaceuticals, contraceptive products and devices, and injectable medications when the provider submits documentation indicating that the acquisition cost of the product, device, or drug is greater than the reimbursement allowed in §E of this regulation. G. The Program reserves the right to negotiate and establish a different fee for a physician or a group of physicians under contract to a hospital to provide services when a portion of the cost of the contract is paid as the hospital's cost, provided this fee does not exceed limitations set forth in §E of this regulation. H. Supplemental payments on Medicare claims are made subject to the following provisions: (1) Deductible insurance will be paid in full; (2) Beginning with August 1, 2010 dates of service, and subject to the limitations of the State budget, coinsurance, shall be paid: (a) In full for the following: (i) Mental health services; (ii) CPT codes that are priced by report; (iii) Claims for anesthesia services; (iv) Claims from a federally qualified health center; and (v) HCPCS codes beginning with A through W; and (b) For all other claims, at the lesser of: (i) 100 percent of the coinsurance amount; or (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare are payable according to §E of this regulation. I. Payments on Medicare claims are authorized if the: (1) Provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that services were medically justified; (4) Services are covered by the Program; (5) Initial billing is made directly to Medicare according to Medicare guidelines. J. The provider may not bill the Department or the participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; or (4) Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. K. The Program will make no direct payment to participants. L. The Program will reimburse the provider for dispensed drugs at rates established in COMAR 10.09.03. The provider shall bill the Program in accordance with COMAR 10.09.03 using the Pharmacy Invoice. M. The Program will reimburse the provider for dispensed medical supplies at actual cost or at rates established by COMAR 10.09.12, whichever is less. N. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. O. Providers shall bill the Program in the following manner: (1) A physician whose laboratory is not required to be registered pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under these regulations; (2) A physician whose laboratory is registered as a medical laboratory pursuant to Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, shall bill the Program for laboratory services in accordance with procedures required under COMAR 10.09.09. P. Reimbursement. (1) The Program shall reimburse providers for all laboratory and other diagnostic services performed by a physician, or by authorized personnel under that physician's supervision, for that physician's patients. (2) Reimbursement shall be according to all applicable provisions of COMAR 10.10.06 and fees established according to §D of this regulation. (3) Maximum reimbursement may not exceed the Medicare laboratory fee established by the Maryland Medicare carrier recognized by the Program. (4) The Program shall reimburse providers for mental health services performed by a physician according to the fees established under COMAR 10.21.25 and the requirements of this chapter. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.02.08* A. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.02.09* A. If the Department determines that a provider, physician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the Program; (2) Withholding of payment by the Program; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes a physician from participation in Medicare, the Department will take similar action. C. The Department may consult with the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The Department will give the findings and recommendations of this group consideration. D. The Department will give the provider reasonable notice of its intention to impose sanctions. In the written notice the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. E. A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants, before rendering additional services, that the provider no longer honors Medical Assistance cards. F. If the Department determines that a provider participating in the Program as a case manager has violated any provision of the agreement executed under the terms of Regulation .03B of this chapter, the Program may suspend or disqualify the provider from participating as a case manager without otherwise restricting the provider’s participation as a physician. #### Regulation .10 Appeal Procedures. *COMAR 10.09.02.10* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.02.11* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 03 — Pharmacy Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-103.1, 15-105, 15-118, and 15-148, Annotated Code of Maryland **Administrative History:** Effective date: February 16, 1966 **Administrative History:** Amended effective March 15, 1967; July 1, 1967; December 1, 1969; July 1, 1971; January 22, 1975 (2:2 Md. R. 86); March 18, 1975 (2:9 Md. R. 659); July 1, 1975 (2:15 Md. R. 1066); January 1, 1976 (2:29 Md. R. 1739) **Administrative History:** Existing regulations repealed and new regulations adopted effective September 1, 1976 (3:18 Md. R. 981) **Administrative History:** Regulation .01 amended effective June 1, 1985 (12:10 Md. R. 961); April 30, 1988 (15:8 Md. R. 1009); March 14, 1989 (16:4 Md. R. 497) **Administrative History:** Regulations .01, .02, .04, .05A, .06, .07H, and .09A—C amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1203); expired November 10, 1979 **Administrative History:** Regulations .01, .03, .05 and .07 amended as an emergency provision effective November 15, 1988 (15:23 Md. R. 2654); emergency status expired March 13, 1989 **Administrative History:** Regulations .01, .05C, .07H, H-1 amended as an emergency provision effective October 1, 1982 (10:1 Md. R. 19); adopted permanently effective January 30, 1983 (10:1 Md. R. 29) **Administrative History:** Regulations .01 and .07 amended as an emergency provision effective December 31, 1987 (15:2 Md. R. 117) (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulations .01—.05 and .07 amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1113); amended permanently effective October 23, 1995 (22:21 Md. R. 1615) **Administrative History:** Regulations .01, .05, and .07 amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1081); amended permanently effective December 30, 1996 (23:26 Md. R. 1860) **Administrative History:** Regulations .01B, .05C, and .07C, H—J amended as an emergency provision effective April 1, 1991 (18:8 Md. R. 861); amended permanently effective July 8, 1991 (18:13 Md. R. 1482) **Administrative History:** Regulation .01B amended effective July 1, 1992 (19:11 Md. R. 1015) **Administrative History:** Regulations .01B, .05C, and .07I amended as an emergency provision effective July 9, 1998 (25:16 Md. R. 1261); amended permanently effective October 19, 1998 (25:21 Md. R. 1574) **Administrative History:** Regulation .01B amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) **Administrative History:** Regulation .01B amended effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired effective January 1, 2004 **Administrative History:** Regulation .01B amended effective February 16, 2004 (31:3 Md. R. 207); November 23, 2006 (33:23 Md. R. 1794); April 21, 2008 (35:8 Md. R. 805); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896); December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulations .01C, N, S; .07F, H; and .09A—C amended effective November 11, 1979 (6:22 Md. R. 1779) **Administrative History:** Regulation .01E-1—E-3 adopted effective December 26, 1980 (7:26 Md. R. 2422) **Administrative History:** Regulation .01H-1 amended effective May 5, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .01P amended effective February 8, 1980 (7:3 Md. R. 263) **Administrative History:** Regulations .02B; .04F (recodified from §H); .05B; .07F-1, H-1 (recodified from §§G and J, respectively) adopted effective November 11, 1979 (6:22 Md. R. 1779) **Administrative History:** Regulation .03 amended effective March 14, 1989 (16:4 Md. R. 497); November 28, 2011 (38:24 Md., R. 1502); March 31, 2014 (41:6 Md. R. 378); September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .03K adopted effective January 6, 1983 (9:26 Md. R. 2572) **Administrative History:** Regulation .03L adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .04 amended effective May 1, 1979 (6:7 Md. R. 576); February 8, 1980 (7:3 Md. R. 263); July 11, 1988 (15:14 Md. R. 1654); November 28, 2011 (38:24 Md., R. 1502); June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .04A amended effective October 17, 1980 (7:21 Md. R. 1994); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637); July 1, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .04A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707) **Administrative History:** Regulation .04A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822) **Administrative History:** Regulation .04A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) **Administrative History:** Regulation .04A amended effective March 3, 2003 (30:4 Md. R. 316); February 16, 2004 (31:3 Md. R. 207); September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .04C adopted effective March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .04E amended effective October 29, 1984 (11:21 Md. R. 1811) **Administrative History:** Regulation .04G adopted effective March 9, 1987 (14:5 Md. R. 579) **Administrative History:** Regulation .05 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) **Administrative History:** Regulation .05 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .05A amended effective May 1, 1979 (6:7 Md. R. 576); November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); October 17, 1980 (7:21 Md. R. 1994); October 29, 1984 (11:21 Md. R. 1811); March 9, 1987 (14:5 Md. R. 579); July 11, 1988 (15:14 Md. R. 1654); July 1, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulations .05A amended as an emergency provision effective July 1, 1981 (8:14 Md. R. 1216); adopted permanently effective November 8, 1981 (8:21 Md. R. 1707) **Administrative History:** Regulation .05A amended as an emergency provision effective January 1, 1982 (8:26 Md. R. 2103); adopted permanently effective April 28, 1982 (9:8 Md. R. 822) **Administrative History:** Regulation .05A amended effective February 16, 2004 (31:3 Md. R. 207); March 13, 2006 (33:5 Md. R. 520); June 14, 2021 (48:12 Md. R. 470); March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .05A, C amended effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .05B amended effective July 1, 1992 (19:12 Md. R. 1134) **Administrative History:** Regulation .05C amended effective December 26, 1980 (7:26 Md. R. 2422); March 9, 1987 (14:5 Md. R. 579); September 7, 1987 (14:18 Md. R. 1966); July 11, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:24 Md. R. 2769); March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); March 19, 1990 (17:5 Md. R. 637) **Administrative History:** Regulation .05C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861) **Administrative History:** Regulation .05C amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707) **Administrative History:** Regulation .05C amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); amended permanently effective November 10, 2003 (30:22 Md. R. 1579) **Administrative History:** Regulation .05C amended effective September 27, 2004 (31:19 Md. R. 1432); August 1, 2005 (32:15 Md. R. 1320); December 6, 2007 (34:24 Md. R. 2157); March 31, 2014 (41:6 Md. R. 378) **Administrative History:** Regulation .05D and E adopted as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769) **Administrative History:** Regulation .05F and G adopted effective April 21, 2008 (35:8 Md. R. 805) **Administrative History:** Regulation .05-1 adopted as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); adopted permanently effective December 1, 1992 (19:23 Md. R. 2040) **Administrative History:** Regulation .05-1 amended effective November 28, 2011 (38:24 Md., R. 1502) **Administrative History:** Regulation .05-1A amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) **Administrative History:** Regulation .05-1A amended effective March 3, 2003 (30:4 Md. R. 316); September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .06 amended effective November 11, 1979 (6:22 Md. R. 1779); February 8, 1980 (7:3 Md. R. 263); November 8, 1981 (8:21 Md. R. 1707); August 30, 1982 (9:17 Md. R. 1708); December 19, 1983 (10:25 Md. R. 2268); October 29, 1984 (11:21 Md. R. 1811); September 7, 1987 (14:18 Md. R. 1966); December 12, 1988 (15:24 Md. R. 2769) **Administrative History:** Regulation .06 amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) **Administrative History:** Regulation .06 amended effective March 3, 2003 (30:4 Md. R. 316); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .06A amended effective July 1, 1992 (19:12 Md. R. 1134); October 10, 2016 (43:20 Md. R. 1109); June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .06A, C amended effective December 6, 2007 (34:24 Md. R. 2157) **Administrative History:** Regulation .07 amended effective March 14, 1989 (16:4 Md. R. 497); July 1, 1989 (16:12 Md. R. 1336); November 28, 2011 (38:24 Md., R. 1502); September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .07C amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .07C amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07C amended as an emergency provision effective January 1, 1991 (18:2 Md. R. 145); emergency status expired effective March 31, 1991 (18:8 Md. R. 861) **Administrative History:** Regulation .07G amended effective June 1, 1985 (12:10 Md. R. 961); May 5, 1986 (13:9 Md. R. 1029); May 4, 1987 (14:9 Md. R. 1080); October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009); July 11, 1988 (15:14 Md. R. 1654) **Administrative History:** Regulation .07G amended as an emergency provision effective August 30, 1988 (15:20 Md. R. 2331); adopted permanently effective January 1, 1989 (15:24 Md. R. 2769) **Administrative History:** Regulation .07H amended as an emergency provision effective July 1, 1977 (4:14 Md. R. 1080); emergency status extended at 4:23 Md. R. 1728; adopted permanently effective November 4, 1977 (4:23 Md. R. 1734) **Administrative History:** Regulation .07H amended effective July 1, 1978 (5:12 Md. R. 967); May 1, 1979 (6:7 Md. R. 576); July 1, 1980 (7:13 Md. R. 1278); March 9, 1987 (14:5 Md. R. 579); July 1, 1987 (14:13 Md. R. 1473); July 11, 1988 (15:14 Md. R. 1654) **Administrative History:** Regulation .07H amended as an emergency provision effective July 2, 1979 (6:14 Md. R. 1204); adopted permanently effective November 2, 1979 (6:22 Md. R. 1779) **Administrative History:** Regulation .07H amended as an emergency provision effective July 1, 1982 (9:11 Md. R. 1122); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) **Administrative History:** Regulation .07H amended as an emergency provision effective July 1, 1984 (11:14 Md. R. 1246); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811) **Administrative History:** Regulation .07H-1 amended effective March 9, 1987 (14:5 Md. R. 579) **Administrative History:** Regulation .07H, I amended effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Regulation .07I amended effective March 19, 1990 (17:5 Md. R. 637) **Administrative History:** Regulation .07I amended as an emergency provision effective July 30, 1991 (18:17 Md. R. 1911); amended permanently effective October 15, 1991 (18:19 Md. R 2099) **Administrative History:** Regulation .07I amended as an emergency provision effective July 1, 1992 (19:12 Md. R. 1130); amended permanently effective October 1, 1992 (19:19 Md. R. 1707) **Administrative History:** Regulation .07I amended as an emergency provision effective November 18, 2002 (29:24 Md. R. 1912) **Administrative History:** Regulation .07I amended effective March 3, 2003 (30:4 Md. R. 316); June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .07J adopted as an emergency provision effective July 1, 1980 (7:13 Md. R. 1266); adopted permanently effective October 17, 1980 (7:21 Md. R. 1995) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .12 adopted effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .12 amended as an emergency provision effective September 18, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .12E amended effective November 23, 2006 (33:23 Md. R. 1794) **Administrative History:** Regulation .12G amended effective December 6, 2007 (34:24 Md. R. 2157) **Administrative History:** Table I adopted effective June 1, 1985 (12:10 Md. R. 961) **Administrative History:** Table I repealed and new Table I adopted effective May 5, 1986 (13:9 Md. R. 1029); amended effective October 5, 1987 (14:20 Md. R. 2142); April 30, 1988 (15:8 Md. R. 1009) #### Regulation .01 Definitions. *COMAR 10.09.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) "340B price" means the price at which drugs are purchased as authorized under Section 340B of the Public Health Service Act. (2) “Actual acquisition cost (AAC)” means the amount paid by a provider for a drug or product less all discounts, rebates, refunds, chargebacks, incentives, and price reductions. (3) “Allowable cost” means the maximum amount which the Program will reimburse for the drug or product portion of the prescription. (4) “Approved unit dose system” means a drug distribution system approved by the Department that is used to prepare and distribute an individual, properly labeled dose of medication for a patient in a nursing facility. (5) “Brand name drug” means: (a) A single source drug; (b) An innovator multiple source drug; or (c) A drug submitted for payment as brand medically necessary. (6) “Compounded prescription for intravenous therapy” means a prescription that: (a) Combines two or more ingredients; (b) Is prepared by using aseptic technique under a laminar flow clean bench; and (c) Is administered to a patient intravenously. (7) “Controlled substance” means a drug as defined under 21 U.S.C. §802. (8) “Convenience package” means a smaller or specially packaged quantity of a product prepared for the convenience of a patient or provider as opposed to the regular packaging. (9) “Copayment” means the amount a participant is liable to pay for prescriptions, when applicable, which is deducted from provider reimbursement. (10) “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX, Social Security Act, 42 U.S.C. §1396 et seq. (11) “Diluent component” means a liquid used for reconstitution or dilution of an active ingredient in compounded prescription intravenous therapy. (12) “Direct price” means, for drugs identified by the Program, the price charged by a pharmaceutical manufacturer to a dispensing pharmacy for a product supplied to the pharmacy without intermediate distribution charges, less any rebates, discounts, refunds, chargebacks, incentives, and price reductions. (13) “Drugs” means legend drugs (those requiring a prescription under federal or State law) or over-the-counter (OTC) drugs (those not requiring a prescription under federal or State law). (14) “Early and periodic screening, diagnosis, and treatment (EPSDT)” means a program of preventive health care services for Medical Assistance individuals younger than 21 years old. (15) “EPSDT-related service” means diagnosis and treatment necessary to correct or manage health problems detected by a screening performed by a certified EPSDT provider. EPSDT-related services are rendered by a certified EPSDT provider or an appropriate Medical Assistance provider. (16) “Family planning services” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health. (17) “Federally qualified health center (FQHC)” means an entity as defined by Health-General Article, §24-1301, Annotated Code of Maryland, and §1905(l)(2)(B) of the Social Security Act. (18) “Federal supply schedule (FSS)” means the drug pricing program under the collection of multiple award contracts used by federal agencies, U.S. territories, Indian tribes, and other specified entities to purchase supplies and services from outside vendors. (19) “Federal upper limit (FUL)” means the upper limit of payment for multiple source drugs for which a specific maximum allowable cost has been established by the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services pursuant to 42 CFR §447.514. (20) “Freestanding clinics” means those clinics, not associated with a hospital, which are under the direction of physicians as further defined in COMAR 10.09.08.01. (21) “Generic drug” means a drug that is: (a) Available to pharmacy providers from at least one manufacturer; (b) Rated as therapeutically equivalent by the U.S. Food and Drug Administration; and (c) Not a brand name drug. (22) “Innovator multiple source drug” means a multiple source drug that was originally marketed under an original new drug application approved by the U.S. Food and Drug Administration. (23) “Institutional pharmacy” means a pharmacy owned and operated by a hospital, nursing facility, or clinic. (24) “Invoice” means: (a) A form issued or approved by the Department for use by providers in submitting bills for payment; or (b) A bill issued by a manufacturer or wholesaler to a provider which indicates proof of purchase and the: (i) Actual acquisition cost paid by the provider; or (ii) The direct price charged to the provider by the manufacturer. (25) “Maintenance medication” means medication in chronic therapeutic categories corresponding to the following American Hospital Formulary Service (AHFS) classification numbers: (a) Cardiac drugs (24:04); (b) Antilipemic agents (24:06); (c) Hypotensive agents (24:08); (d) Vasodilating agents (24:12); (e) Sclerosing agents (24:16); (f) Alpha-adrenergic blocking agents (24:20); (g) Beta-adrenergic blocking agents (24:24); (h) Calcium-channel blocking agents (24:28); (i) Renin-angiotensin-aldosterone system inhibitors (24:32); (j) Hydantoins (28:12:12); (k) Oxazolidinediones (28:12:16); (l) Succinimides (28:12:20); (m) Anticonvulsants, miscellaneous (28:12:92); (n) Replacement solutions (40:12) (potassium supplements only); (o) Diuretics (40:28); (p) Lipotropic agents (56:24); (q) Contraceptives (68:12); (r) Estrogens and antiestrogens (68:16); (s) Antidiabetic agents (68:20); (t) Antihypoglycemic agents (68:22); (u) Parathyroid (68:24); (v) Progestins (68:32); (w) Thyroid and antithyroid agents (68:36); (x) Vitamins (88:00); (y) Sodium fluoride (92:00); and (z) Iron preparations, oral (20.04.04) (oral products in which ferrous sulfate is the only active ingredient and chewable tablets of any ferrous salt if combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation). (26) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (27) “National average drug acquisition cost (NADAC)” means the average price paid by retail community pharmacies to acquire a prescription or over-the-counter covered out-patient drug as calculated by the Centers for Medicare and Medicaid Services. (28) “Nominal price” means a price that is less than 10 percent of the average manufacturer price (AMP) in the same quarter for which AMP is computed. (29) “Nursing facility” means an institution as further defined in COMAR 10.09.10.01B(30), and classified as a long-term care facility. (30) “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. (31) “Pharmacist” means an individual licensed in good standing to practice pharmacy in the state where the service is provided. (32) “Pharmacy” means an establishment or institution licensed in good standing that is required to obtain a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland, or a similar entity legally authorized to dispense legend drugs to the public in the state in which the establishment or institution is located. (33) “Pharmacy and Therapeutics Committee” means a committee established by the Department to develop recommendations for pharmacy practices including but not limited to development of a preferred drug list according to Regulation .12 of this chapter. (34) “Preauthorization” means an approval required from the Department or its designee before a drug is dispensed. (35) “Preferred drug list” means a list of recommended drugs developed by the Department that is based on the recommendations of the Pharmacy and Therapeutics Committee. (36) “Prescriber” means a physician, dentist, podiatrist, or other professional licensed in good standing to prescribe legend drugs in the state in which the service is provided. (37) “Prescription” means an order by a prescriber, or a prescriber’s order transferred from one pharmacist to another, for Program covered pharmacy services in accordance with applicable federal and State laws conveyed in one of the following forms: (a) An original order signed by the prescriber and written on tamper-resistant paper which shall contain industry-recognized features designed to prevent: (i) Unauthorized copying of a prescription form; (ii) Erasure or modification of information written on the prescription by the prescriber; and (iii) Use of counterfeit prescription forms; (b) A fax of an original order signed by the prescriber sent directly from the prescriber to the pharmacy provider; (c) An electronic order; or (d) An oral order from the prescriber to the pharmacist if the: (i) Pharmacist promptly writes or prints out and files the prescription; (ii) Prescription is not for a Schedule II controlled dangerous substance; and (iii) Prescription is not for certain drugs that have been determined by the Secretary to present an emerging threat in the State because of increasing abuse and diversion. (38) “Professional dispensing fee” means the professional fee as defined in 42 CFR §447.502. (39) “Program” means the Maryland Medical Assistance Program. (40) “Provider” means an individual, association, partnership, or incorporated or unincorporated group of individuals duly licensed or certified to provide services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by issuance of an individual account number. (41) “Single source drug” means a covered drug which is produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug product marketed by any cross-licensed producers or distributors operating under the new drug application. (42) “State actual acquisition cost (SAAC)” means, for those drugs or products identified by the Program, the Program’s or its designee’s calculation of AAC, based on a survey of providers’ actual prices paid to acquire drugs or products marketed or sold by specific manufacturers, when NADAC is unavailable. (43) “State Formulary” means drug products listed in the United States Food and Drug Administration's Current List of Approved Drug Products with Therapeutic Equivalence Evaluations unless disqualified by the Department in conformity with Health Occupations Article, §12-504, Annotated Code of Maryland. (44) “State-only participants” means those participants in the Program administered and financed by the State who do not meet the technical requirements of Title XIX of the Social Security Act and for whom the State does not claim federal financial participation. (45) “Usual source of supply” means a wholesaler, distributor, or manufacturer from whom pharmacy providers within the State most frequently obtain their pharmaceuticals. (46) “Wholesale acquisition cost (WAC)” means the price pharmaceutical manufacturers and distributors charge to wholesale distributors who provide retail and institutional pharmacies with products used to fill prescriptions. #### Regulation .02 License Requirements. *COMAR 10.09.03.02* A. A pharmacy may not qualify as a provider without first having obtained a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located. B. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19. C. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery and to dispense drugs in the state in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.03.03* To participate in the Program, the provider shall: A. Meet the licensure requirements in Regulation .02 of this chapter; B. Apply for participation in the Program using the application form designated by the Department; C. Be approved for participation by the Department; D. Accept, as payment in full, the amounts paid by the Program plus any copayment required by Regulation .05C(5) of this chapter; E. Maintain adequate records and prescriptions for a minimum of 6 years, and make them available for inspection, upon request, to the Department or its designee; F. Ensure that all prescriptions contain sufficient information to justify the invoice charges; G. Provide services without regard to race, creed, color, age, sex, national origin, marital status, physical or mental handicap; H. Agree that the provider may not employ knowingly a person who has been disqualified from the Program to compound or dispense Medical Assistance prescriptions, unless prior written approval has been received from the Department; I. Verify the participant’s eligibility before dispensing covered drugs; J. Place no restriction on the participant’s right to select providers of the participant’s choice; K. Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant; L. Maintain a record of the individual who picks up a prescription that includes: (1) The prescription number; (2) The name of the individual picking up the prescription; (3) The signature of the individual picking up the prescription; and (4) The date the prescription was picked up; M. Reverse invoice charges for any prescription not picked up by the participant or their designee within 14 days; N. Maintain a record of a participant or designee’s written authorization for automatic refill, if automatic refills are provided; O. Agree that the provider may not deny services to any participant because of the individual’s inability to pay the copayment; P. Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant; Q. On the Department’s request, provide within 15 days all invoices, as defined in Regulation .01B(24)(b) of this chapter, to assess the AAC; and R. Participate in the cost of dispensing survey and, on the Department’s request and within the Department’s timeline, provide to the Department all documentation that the Department or its designee determines is necessary. #### Regulation .04 Covered Services. *COMAR 10.09.03.04* A. The Department shall cover: (1) Legend drugs except certain drugs for which federal financial participation is prohibited pursuant to 42 CFR §441.25; (2) Schedule V cough preparations; (3) Contraceptives; (4) Hypodermic needles and syringes; (5) Supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home; (6) Enteric coated aspirin when prescribed for: (a) The treatment of arthritic conditions as certified on the prescription in the prescriber's own handwriting or by the dispenser after consultation with the prescriber; and (b) At least 250 tablets of 325 milligrams each, whether for initial prescriptions or refills. (7) Nonlegend ferrous sulfate oral preparations in the following strengths, dosage forms, and quantities only: (a) Drops (125 milligrams per milliliter) in units of 50 milliliter dropper bottles; (b) Elixir (220 milligrams per 5 milliliters) in quantities of at least 473 milliliters; (c) Syrup (90 milligrams per 5 milliliters) in quantities of at least 473 milliliters; and (d) Tablets (300 milligrams to 325 milligrams) in quantities of at least 100 tablets; (8) Nonlegend chewable tablets of any ferrous salt if: (a) The tables are combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals; (b) The participant is under 12 years old; and (c) The quantity dispensed is at least 60 tablets and not more than a 100-day supply; (9) Nonlegend ergocalciferol liquid (8,000 international units per milliliter); and (10) Any nonlegend drug determined by the Program to be cost effective. B. Prescription Requirement. (1) Except as provided in §B(2) of this regulation, a prescription is required for all items to be covered under this regulation even if the item is not a legend drug or otherwise does not require a prescription under federal or State pharmacy law. (2) A prescription is not required for various forms of latex condoms or other drugs or products identified by the Program, each within the limits established by the Program. C. The Department may cover legend drugs not otherwise covered by §A of this regulation when: (1) The drugs are identified as necessary to address a drug shortage as identified by the United States Food and Drug Administration; and (2) The Department determines the coverage of the drugs medically necessary. #### Regulation .05 Limitations. *COMAR 10.09.03.05* A. Except as specifically identified as being covered under Regulation .04 of this chapter, the following are not covered: (1) Nonlegend drugs; (2) Medical supplies and durable equipment; (3) Any original prescription for a controlled substance dispensed more than 30 days after the date it was ordered; (4) Drugs supplied to hospital inpatients; (5) Drugs and supplies dispensed by the provider with an actual acquisition cost of $0; (6) Experimental or investigational drugs; (7) Except where authorized by the Department to be covered under this Regulation, injectables dispensed by a provider for administration by the prescriber; (8) Food supplements or infant formulas, including supplemental vitamin and mineral products when administered orally; (9) Sugar or salt substitutes; (10) Cosmetics, medicine chest supplies, and sundries including all soaps, all body powders, all body oils or body lotions, cotton balls, adhesive strip bandages, cotton-tipped applicators, suntan products, deodorants, dentifrices, tissues, convenience packages of covered items, hot water bottles, ice caps, heating pads, soft cervical collars; (11) Alcoholic beverages; (12) Ostomy supplies; (13) Those services authorized for payment to a prescriber, hospital, nursing facility, hospital outpatient department, or freestanding clinic; (14) Oral drugs or injections for central nervous system stimulants, anorexigenics, and any other agents when used for weight control; (15) Drug products for which federal financial participation is prohibited pursuant to 42 CFR §441.25; (16) Ovulation stimulants unless used to treat an iatrogenic infertility; (17) Effective January 1, 2006, any Part D drug for individuals who are eligible for Medicare Part D benefits; (18) Drugs or products used for hair growth or other cosmetic purposes; (19) Any drug or supply that is covered and reimbursed by the Department under any other chapter of this subtitle; and (20) Any drug or product the Department determines is not medically necessary. B. Prescriptions requiring preauthorization according to Regulation .06 of this chapter are not covered unless the required preauthorization has been obtained from the Department or its designee. C. Limitations on Covered Services. (1) The allowable cost of ingredients dispensed pursuant to a prescription may not exceed an upper limit as established in Regulation .07, of this chapter. (2) Refills. (a) The prescriber shall authorize refills only on the original prescription if the prescriber determines a refill is necessary and appropriate. (b) The Program may authorize no more than 11 refills, not to exceed other applicable federal and State limitations. (c) The pharmacy may not automatically refill a prescription unless authorized in writing by the recipient or their designee. (3) Days Supply. (a) The total amount dispensed under one prescription order, including refills, is limited to a 360 days supply, not to exceed other applicable federal and State limitations. (b) Unless otherwise specified, prescriptions shall be limited to a 34 day supply at one time. (c) Unless otherwise specified, maintenance medication shall be limited to: (i) A 34-day supply for the initial prescription; and (ii) Up to a 100-day supply at one time for all subsequent prescriptions. (d) Prescriptions shall be dispensed at the lower of the quantity prescribed or the maximum days supply allowed at one time unless: (i) The Program authorizes a reduction of the quantity; or (ii) The prescription is the final refill for the balance remaining on the total prescription order. (e) Providers may partially fill a prescription for Schedule II controlled dangerous substances, but the remaining portion of the prescription may not be later filled. (f) Oral sodium fluoride products used in the prevention of dental caries are limited to an original prescription of up to a 120-day supply with up to two refills, not to exceed a total of a 360-day supply. (g) Prescriptions for drugs packaged by the manufacturer as an unbreakable unit may be dispensed in increments of appropriate package size. (h) Whether for an initial or subsequent prescription, contraceptive prescriptions may be dispensed in up to a 12 months supply at one time. (4) Generic Drugs. (a) Except as limited by §C(4)(b) and (c) of this regulation, when a drug product is prescribed by its nonproprietary or generic name, a provider shall substitute as follows: (i) A drug product in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, therapeutically equivalent to the drug as prescribed; or (ii) A drug product with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed drug which is, in the provider’s professional opinion, bioequivalent to the drug as prescribed as rated by the U.S. Food and Drug Administration. (b) A provider may not substitute a generic drug for a brand name drug under §C(4)(a) of this regulation if: (i) The prescriber specifically directs otherwise; and (ii) The prescriber requests and received approval from the Program. (c) The Department shall only authorize a provider to substitute a drug product under this regulation when there will be a savings in or no increase in cost to the Department. (5) Copayment for Services Rendered on or after July 1, 2005. (a) There will be no pharmacy copayment for prescriptions for the following: (i) Individuals younger than 21 years old; (ii) Pregnant women; (iii) Institutionalized individuals who are inpatients in long-term care facilities or other institutions requiring spending all but a minimal amount of income for medical costs; (iv) Family planning drugs and devices; and (v) Individuals who are American Indians or Alaskan Natives. (b) The copayments for prescriptions not excluded from a copayment under §C(5)(a) of this regulation are: (i) $3 for prescriptions for brand name drugs not on the preferred drug list; (ii) $1 for prescriptions for generic drugs and brand name drugs on the preferred drug list; and (iii) $1 for prescriptions for antiretroviral drugs in American Hospital Formulary Service therapeutic class 8:18:08. (6) Reimbursement may not be made: (a) For nonlegend enteric coated aspirin tablets in strengths other than 300 to 325 milligrams; (b) For any other nonlegend aspirin products such as sustained release capsules, buffered tablets, compressed tablets, liquid preparations or combination products in which aspirin is only one of the active ingredients; (c) For nonlegend ferrous sulfate products in strengths or dosage forms not listed in Regulation .04A(8) of this chapter; (d) For nonlegend iron products combined with other active ingredients, except for chewable tablets as described in Regulation .04A(9) of this chapter; or (e) At a reimbursement level which exceeds the maximum allowable cost established by the Program. (7) Condoms dispensed by pharmacy providers are subject to the following limitations: (a) The recipient shall present a Medical Assistance card with a current eligibility period; (b) Only 12 condoms may be dispensed to an individual at one time; (c) The provider may dispense condoms only to the individual named on the Medical Assistance card; (d) Natural membrane condoms are not covered; and (e) Both the recipient receiving the condoms and the provider shall sign the dispensing documentation. (8) A compounded prescription for intravenous therapy is subject to the following limitations: (a) The Program may not cover a compounded prescription for intravenous therapy if a premixed, therapeutically equivalent commercial intravenous therapy is available from a commercial source; (b) The Program may not cover the diluent component of a compounded prescription for intravenous therapy; and (c) All claims submitted require new prescription numbers. (9) Prescriptions dispensed to participants residing in nursing facilities are subject to the following limitations: (a) Claims shall be identified as nursing facilities prescriptions by coding mechanisms determined by the Program; (b) Credits for unused unit dose medication and any other medication which may legally be returned to pharmacy stock: (i) Shall be made within 60 days of Program payment; (ii) May not take into account any professional fee paid by the Program; and (iii) Shall adjust for leave of absence prescriptions; and (c) Multiple prescriptions dispensed to a recipient residing in a nursing facility for the same drug product or compounded prescription shall receive only one professional fee per calendar month except for: (i) Leave of absence prescriptions; (ii) Prescriptions for intravenous therapy; and (iii) Prescriptions for Schedule II-V controlled substances. D. Tamper Resistant Prescriptions. (1) Prescriptions written on or after April 1, 2008, that do not contain at least one of the tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered. (2) Prescriptions written on or after October 1, 2008, that do not contain all three tamper-resistant features as defined in Regulation .01B(34)(a) of this chapter are not covered. E. No covered drug or supply identified under Regulation .04 of this chapter shall be reimbursed under Regulation .07 of this chapter if: (1) Federal financial participation from the Centers for Medicare & Medicaid Services is not available for the drug or supply; or (2) Prior authorization for the drug or supply is required under Regulation .06 of this chapter but was not obtained. #### Regulation .05-1 Expanded Limitations. *COMAR 10.09.03.05-1* A. A drug is not covered for State-only participants if: (1) The manufacturer has not provided the same rebate to the State for State-only participants’ purchases of drugs as is required under Section 1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)); (2) The Program has provided notice to the manufacturer of the manufacturer's failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and (3) The manufacturer has failed to demonstrate to the Secretary that the drug’s availability is essential to State-Only participants. B. A manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation or under 42 U.S.C. §1396r-8(c) more than 3 years after the date the rebate was paid. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.03.06* A. The provider shall obtain preauthorization from the Department or its designee for any prescription for: (1) Antibiotic liquids requiring reconstitution for amounts exceeding a 14-day supply; (2) Nonmaintenance drugs for more than a 34 day supply; (3) A usual and customary charge exceeding $2,500; (4) Female hormones for biologic males when used for treating sexual aggression; (5) Vitamin and mineral products when given by nasogastric, jejunostomy, or gastrostomy tube in the home; (6) Drugs rejected by the point-of-sale system because of edits established by the Program to ensure appropriate utilization of medication before the prescription is dispensed, if the Department does not allow provider level overrides; (7) Where a prescriber has filed an official report of an adverse event or product problem with the Program or the United States Food and Drug Administration regarding a generic drug, the brand name drug used as an alternative to that generic drug; (8) Drugs identified by the Program that are subject to fraud or abuse; or (9) Drugs not on the preferred drug list developed under Regulation .12 of this chapter except for: (a) Antiretrovirals; or (b) Any other drugs or classes of drugs as determined by the Department. B. Off-Label Uses of Drugs. (1) The Department may require preauthorization for an off-label use of a drug. (2) Except as provided in §B(3) of this regulation, the Department or its designee may not grant preauthorization for an off-label use of the drug if: (a) The off-label use is inconsistent with generally accepted standards of care; (b) The drug is prescribed for a non-medically accepted indication; (c) The drug is prescribed in a manner not approved by the U.S. Food and Drug Administration; or (d) The off-label use is not documented in and supported by the latest edition of: (i) The American Hospital Formulary Service Drug Information (AHFS-DI); (ii) The Thompson Micromedex Drugdex; or (iii) The United States Pharmacopeia. (3) The Department or its designee may grant preauthorization for the off-label use of mental health drugs for individuals 18 years old and younger within the limits established by the Program. C. Preauthorization is not required for: (1) Prescriptions for oral contraceptive drug products; (2) Drugs dispensed in unit dose form to patients in a nursing facility by a provider using an approved unit dose system. D. Preauthorization Process. (1) The provider or the prescriber, if appropriate, ordering a drug subject to preauthorization, shall: (a) Contact the Department or its designee through an established 24-hour hot-line to request preauthorization; and (b) Provide required information and documentation. (2) The Department or its designee shall respond to a request for preauthorization by telephone or facsimile request within 24 hours of receipt of a request for preauthorization. (3) A 72-hour supply of the prescribed drug shall be allowed: (a) In an emergency as determined by the prescriber; (b) In an emergency as determined by the pharmacist, if possible in consultation with the prescriber; or (c) If the Department does not provide a response to a preauthorization request within 24 hours. (4) A preauthorization granted by the Department or its designee under this Regulation may not be used by any person as indicating that the individual for whom the prescription was ordered is eligible for Program benefits on the day the prescription is filled or that the Department will guarantee reimbursement for the prescription. All Program restrictions and requirements on eligibility, covered services, and limitations on reimbursement remain in effect. (5) A 30-day emergency supply of atypical antipsychotic drugs not on the preferred drug list shall be: (a) Immediately authorized by the Department or its designee in an emergency as determined by the: (i) Prescriber; or (ii) Pharmacist, if unable to contact the prescriber; and (b) Limited to a one-time 30-day period. E. Reconsideration of Adverse Decisions. (1) The Department or its designee shall respond within 48 hours of receiving all necessary documentation of a written request from a participant or provider for reconsideration of an adverse decision on a preauthorization request. (2) The Department or its designee shall ensure that all adverse decisions of reconsiderations are reviewed and issued by a physician. (3) Appeals of adverse decisions of reconsideration requests shall be filed in accordance with Regulation .10 of this chapter. F. The Department or its designee may: (1) Require preauthorization for more than ten prescriptions including refills per 30-day period per noninstitutionalized participant; and (2) May exclude certain drugs such as antibiotics from the limit as appropriate. #### Regulation .07 Payment Procedures. *COMAR 10.09.03.07* A. The provider shall produce records to verify any charge to the Program upon request. B. The provider shall bill all appropriate insurance carriers before requesting payment from the Department. C. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. D. The provider shall submit a request for payment on a form designated by the Department. E. The Department may return to the provider all invoices not properly completed. F. The pharmacy provider shall charge the Program the provider’s usual and customary charge to the general public for similar prescriptions. G. The physician or osteopath shall charge the Program his actual acquisition cost for the drugs dispensed. H. Determination of Allowable Cost. (1) For covered legend drugs and nonlegend drugs, allowable cost shall be: (a) The NADAC; or (b) When the NADAC is unavailable, the lowest of the: (i) WAC plus 0 percent; (ii) FUL; and (iii) SAAC. (2) For covered legend brand name drugs for which the prescriber files an official report of an adverse event or product problem regarding a generic drug with the Program or the United States Food and Drug Administration, or when the Department requires the brand name drugs to be dispensed, the allowable cost shall be: (a) The NADAC of the branded product; or (b) When the NADAC of the branded product is unavailable, the lower of the: (i) WAC plus 0 percent; or (ii) SAAC. (3) For condoms dispensed by pharmacy providers, the allowable cost shall be as described in §H(1) of this regulation. (4) For covered over-the-counter products, and covered medical supplies, the allowable cost shall be as described in §H(1) of this regulation. (5) For covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail, the allowable cost shall be: (a) The NADAC; or (b) When the NADAC is unavailable, the lowest of the: (i) WAC plus 0 percent; (ii) FUL; or (iii) SAAC. (6) Except when purchased at the 340B price by a provider, the allowable cost for covered clotting factors shall be the lower of the: (a) WAC plus 0 percent; or (b) AAC plus 8 percent. (7) For 340B covered entities or FQHCs that fill Program participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act, the allowable cost shall be the provider’s AAC. (8) For facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS, the allowable cost shall be the provider’s AAC. (9) For facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, the allowable cost shall be the provider’s AAC. I. Payment for Covered Services to a Pharmacy. (1) Payment for covered legend and nonlegend drugs, over-the-counter products, and covered medical supplies is the lower of: (a) The provider's charge according to §F of this regulation, less any applicable co-payment according to Regulation .05C(5) of this chapter; or (b) The amount that is: (i) The allowable cost of the item in §H(1) of this regulation; (ii) Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and (iii) Less any applicable copayment according to Regulation .05C(5) of this chapter. (2) Payment for covered legend brand name drugs as indicated in §H(2) of this regulation shall be the lower of: (a) The provider’s charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or (b) The total of: (i) The allowable cost of the item in §H(2) of this regulation; (ii) Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and (iii) Less any applicable copayment according to Regulation .05C(5) of this chapter. (3) Payment for condoms will be the lower of the: (a) The provider's charge according to §F of this regulation; or (b) Allowable cost according to §H(3) of this regulation. (4) Copayment is not required for condom orders. (5) Payment for covered specialty drugs not dispensed by a retail community pharmacy but dispensed primarily through the mail shall be the lower of the: (a) Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or (b) The total of: (i) The allowable cost of the item in §H(5) of this regulation; (ii) Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and (iii) Less any applicable copayment according to Regulation .05C(5) of this chapter. (6) Payment for clotting factor shall be lower of the: (a) Provider charge according to §F of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter; or (b) Amount that is: (i) The allowable cost of the item in §H(6) of this regulation; (ii) Plus the applicable professional dispensing fee indicated in §I(11) of this regulation; and (iii) Less any applicable copayment according to Regulation .05C(5) of this chapter. (7) Payment for providers that fill Medicaid participant prescriptions with drugs purchased at the prices authorized under Section 340B of the Public Health Service Act shall be the total of: (a) The allowable cost of the item in §H(7) of this regulation; (b) Plus the applicable professional dispensing fee indicated in §I(12) of this regulation; and (c) Less any applicable copayment according to Regulation .05C(5) of this chapter. (8) Payment for facilities that fill Medicaid participant prescriptions with drugs purchased through the FSS shall be the total of: (a) The allowable cost of item in §H(8) this regulation; (b) Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and (c) Less any applicable copayment according to Regulation .05C(5) of this chapter. (9) Payment for facilities that fill Medicaid participant prescriptions with drugs purchased at nominal price, outside of 340B and FSS, shall be the total of: (a) The allowable cost of item in §H(9) this regulation; (b) Plus the applicable professional dispensing fee indicated in §I(10) or (11) of this regulation; and (c) Less any applicable copayment according to Regulation .05C(5) of this chapter. (10) The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for participants residing in nursing facilities shall be $11.67. (11) The professional dispensing fee for covered services rendered on or after February 1, 2021 to a pharmacy for individuals other than residents in nursing facilities shall be $10.67. (12) The professional dispensing fee for covered services rendered on or after April 1, 2017 to a pharmacy for medication purchased at the prices authorized under Section 340B of the Public Health Services Act shall be $12.12. (13) The Department may pay a pharmacy using an approved unit dose system on the basis of a monthly dispensing fee per nursing home resident. The value of the fee may not be higher than the pharmacy’s usual and customary charge to non-Medicaid patients for similar services. J. Payment for Covered Services to a Physician or Osteopath. (1) Except as provided in §J(2) of this regulation, the Program shall reimburse a physician or osteopath for covered drugs dispensed at the lower of: (a) The physician's or osteopath's actual acquisition cost, less any applicable copayment according to Regulation .05C(5) of this chapter; or (b) The allowable cost of the item in §H of this regulation, less any applicable copayment according to Regulation .05C(5) of this chapter. (2) The Program shall reimburse a physician or osteopath for covered drugs dispensed to Medicaid participants on the same basis as reimbursement to a registered pharmacist if: (a) The physician or osteopath dispenses the covered drugs on a regular basis in the physician's or osteopath’s office; (b) The physician's or osteopath’s office is not located within a 10-mile radius of a Medicaid participating pharmacy; and (c) The Program, after consultation with the Board of Pharmacy, has verified that the physician or osteopath is dispensing drugs in accordance with accepted pharmacy standards. K. In order to determine whether the current professional dispensing fee is appropriate, the Department will periodically conduct surveys to determine the actual costs involved in filling a prescription in the State. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.03.08* A. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or third-party source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.03.09* A. If the Department determines that a provider, pharmacist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from Program; (2) Withholding of payment by the Program; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. C. The Department may consult with the State Pharmaceutical Association, the State Board of Pharmacy, and the Peer Review Committee of the Medical and Chirurgical Faculty of Maryland. The findings and recommendations of these groups will be given consideration. D. The Department will give the provider reasonable notice of its intentions to impose sanctions. In the written notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. E. Any provider voluntarily withdrawing from the Program or removed or suspended from the Program according to this section shall notify recipients that he no longer honors Medical Assistance cards before rendering additional services. #### Regulation .10 Appeal Procedures. *COMAR 10.09.03.10* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.03.11* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. #### Regulation .12 Preferred Drug Program. *COMAR 10.09.03.12* A. The Department may establish a Pharmacy and Therapeutics Committee (Committee). B. The Committee shall consist of the following 12 members: (1) Five members of the Committee shall be Maryland licensed pharmacists residing in the State, including a pharmacist with expertise with mental health drugs; (2) Five members of the Committee shall be Maryland licensed physicians residing in the State, including a psychiatrist; and (3) Two members of the Committee shall be consumer representatives residing in the State. C. Consideration for membership on the Committee shall be given to appointing physicians and pharmacists participating in the Program or with experience in developing or practicing under a preferred drug list. D. The Committee members shall: (1) Be appointed by the Secretary; (2) Have 3 year terms; (3) Be allowed to serve more than one term; and (4) Elect a chairman and vice chairman. E. The Committee shall: (1) Meet at least twice a year; (2) To the extent feasible, review all drug classes included on the list at least once every 12 months; (3) Develop recommendations for a preferred drug list for the Program by considering the: (a) Clinical efficacy of the drug; (b) Cost effectiveness of the drug, including any supplemental rebates from manufacturers; and (c) Needs of Program recipients, such as the ease of drug therapy administration, rate of compliance with drug therapy instructions, and frequency of prior authorization; (4) Recommend: (a) The addition or deletion of existing drugs as necessary; (b) Preauthorization criteria; and (c) Conditions or illnesses to be exempted from prior authorization based on clinical data; and (5) Consider medically accepted off-label use of U.S. Food and Drug Administration (FDA) approved drugs. F. The Department shall: (1) Inform the Committee of any decisions regarding the preferred drug list; (2) Annually publish the preferred drug list; (3) Maintain an updated preferred drug list that is available electronically; (4) Ensure, based upon timely notice from the manufacturer, that any new products are reviewed at the next regularly scheduled meeting of the committee; (5) Provide an expedited review process for newly approved drugs designated as priority by the FDA; and (6) Provide manufacturers and the public an opportunity to submit written material to the committee. G. The preferred drug list developed by the Department based on the recommendations of the Pharmacy and Therapeutics Committee: (1) May not include certain therapeutic classes including antiretroviral medications used to treat the AIDS virus, which are exempt from preauthorization as indicated in Regulation .06A(12) of this chapter; (2) Shall, for therapeutic classes other than those described in §G(1) of this regulation, include at least one drug approved by the FDA for use in the specific therapeutic class, in every therapeutic class for which the FDA has approved three or fewer drugs for use; and (3) Shall, in every therapeutic class other than those described in §G(1) of this regulation, offer a choice of at least two pharmaceutical or biological entities without an administrative preference for each therapeutic class in which there are four or more pharmaceutical or biological entities approved by the FDA. H. The Department may negotiate and collect supplemental rebates from manufacturers. ### Chapter 04 — Home Health Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1985 (12:11 Md. R. 1048) **Administrative History:** Regulations .01B and .05L amended, and .05M adopted as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulation .01B amended effective November 12, 1990 (17:22 Md. R. 2656) **Administrative History:** Regulation .03C amended effective November 12, 1990 (17:22 Md. R. 2656) **Administrative History:** Regulation .04B amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656) **Administrative History:** Regulation .05F, I amended effective November 12, 1990 (17:22 Md. R. 2656) **Administrative History:** Regulation .05F, J amended effective April 4, 1988 (15:7 Md. R. 849) **Administrative History:** Regulation .06A amended effective April 4, 1988 (15:7 Md. R. 849); November 12, 1990 (17:22 Md. R. 2656) **Administrative History:** Regulation .07E amended effective April 4, 1988 (15:7 Md. R. 849) **Administrative History:** Regulation .07F amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07F amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08B amended effective November 12, 1990 (17:22 Md. R. 2656) **Administrative History:** Regulation .10A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Chapter revised as an emergency provision effective October 1, 2000 (28:1 Md. R. 21); emergency status extended at 28:7 Md. R. 687 and 28:22 Md. R. 1931 (see 28:24 Md. R. 2125); emergency status expired October 28, 2001 **Administrative History:** Chapter revised effective October 29, 2001 (28:21 Md. R. 1856) **Administrative History:** Chapter revised effective March 12, 2007 (34:5 Md. R. 560) **Administrative History:** Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787); September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .02 amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .03 amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .03B amended effective June 14, 2021 (48:12 Md. R. 470); November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .03C amended effective September 30, 2013 (40:19 Md. R. 1544); June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .04 amended effective June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .04B amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .04C repealed effective September 26, 2016 (43:19 Md. R. 1072) **Administrative History:** Regulation .04D amended effective March 10, 2008 (35:5 Md. R. 641) **Administrative History:** Regulation .04D adopted effective November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .05 amended effective December 27, 2010 (37:26 Md. R. 1787); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .05W amended effective March 10, 2008 (35:5 Md. R. 641) **Administrative History:** Regulation .06 amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .06B amended effective June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .07 amended effective December 27, 2010 (37:26 Md. R. 1787); November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .07D amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07D, H amended effective June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .07E amended effective June 14, 2010 (37:12 Md. R. 800); May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .07H adopted effective September 30, 2013 (40:19 Md. R. 1544) **Administrative History:** Regulation .07I adopted effective January 1, 2018 (44:26 Md. R. 1214) #### Regulation .01 Definitions. *COMAR 10.09.04.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means functions normally associated with mobility, eating, elimination, body hygiene and dressing. (2) “Attending” means the role of an individual who establishes the plan of treatment and certifies the necessity for home health services for a participant following a hospitalization. (3) “Case coordinator” means a licensed health professional designated by a home health agency to coordinate the care of a participant. (4) “Certified nurse midwife (CNM)” means an individual who meets licensure requirements and conditions for participation as a certified nurse midwife set forth in COMAR 10.09.01. (5) “Certified nurse practitioner” means an individual who meets the licensing requirements and conditions for participation as a nurse practitioner set forth in COMAR 10.09.01. (6) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. 1396 et seq. (7) “Electronic Visit Verification (EVV)” has the meaning stated in COMAR 10.09.36.03-2. (8) “Face-to-face” means contact with a participant that occurs in person or via audio-visual telehealth in accordance with COMAR 10.09.49. (9) “Health team” means the physician or nonphysician practitioner and the home health agency personnel who render services listed in Regulation .04B of this chapter to a participant. (10) “Home” means the place of residence occupied by the participant, including a domiciliary level facility, but other than a hospital, nursing facility, or other medical institution. (11) “Home health agency” means a public or private agency or organization, or part of an agency or organization, that meets the requirements for participation in Medicare. (12) “Home health aide” means a person who meets the requirements of COMAR 10.07.10, and has received instruction from, and renders services under the supervision of, a registered nurse. (13) “In person” means contact with a participant that occurs in the physical presence of the participant and the provider. (14) “Intermittent” means services which are furnished on a medically predictable recurring basis. (15) “Licensed nurse” means a person who is licensed as a registered nurse or as a licensed practical nurse in the jurisdiction in which the service is provided. (16) “Medicaid average rate” means the average projected per diem rate established for the Department's fiscal year as specified in COMAR 10.09.10.07B(2) multiplied by 30. (17) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (18) “Medical supplies” means items which are generally recognized under accepted standards of medical practice as serving a therapeutic or diagnostic purpose and are medically necessary to enable home health agency personnel to carry out effectively the care the physician has ordered for the treatment or diagnosis of the patient's illness or injury, and which are accounted for in billing records. (19) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. 1395 et seq. (20) “Newborn early discharge assessment” means a visit to the newborn infant and postpartum mother to observe and assess the health status of both the newborn and the mother. (21) “Nonphysician practitioner” means an individual who: (a) Is licensed as a certified nurse practitioner, clinical nurse specialist, a certified nurse-midwife, or a physician assistant in the jurisdiction in which the service is provided; and (b) Works in collaboration with or under the supervision of the ordering practitioner. (22) “Occupational therapist” means a person who is licensed or registered as an occupational therapist in the jurisdiction in which the service is provided. (23) “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. (24) “Part-time” means services, usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of an illness or injury. (25) “Physical therapist” means a person who is licensed or registered as a physical therapist in the jurisdiction in which the service is provided. (26) “Physician” means an individual who meets the licensure requirements and conditions for participation set forth in COMAR 10.09.02. (27) “Physician assistant” means an individual who meets license requirements and conditions for participation set forth in COMAR 10.09.55. (28) “Program” means the Maryland Medical Assistance Program. (29) “Progress note” means a dated, written notation by a member of the health team which summarizes facts about the care given and the patient's response during a given period of time, specifically addresses the established goals of treatment, is consistent with the patient plan of care, is written immediately following each visit, and is part of the provider's permanent record for the participant. (30) “Provider” means a person or an organization who meets the requirements of Regulations .03 and .04 of this chapter and who, through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. (31) “Speech-language pathologist” means a person who is licensed as a speech-language pathologist in the jurisdiction in which the service is provided. (32) “Supervision” means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic evaluation of the act of accomplishing the function or activity. (33) “Support system” means a family member, friend, neighbor, or any person who renders services, which would otherwise be covered under Regulation .04 of this chapter, to the participant. (34) “Telehealth” has the meaning stated in COMAR 10.09.49.02. (35) “Visit” means the time spent rendering a covered service to a participant at home by an individual employed by a home health agency. (36) “Witness” means a person who on behalf of the participant is able to personally verify at the time of service that the participant received home health care. #### Regulation .02 License Requirements. *COMAR 10.09.04.02* A home health agency shall be licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland, or shall be part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland, or shall be legally authorized to provide home health services in the jurisdiction in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.04.03* A. To be a provider, a home health agency shall be a participating home health agency under Medicare. B. To participate in the Program, the home health agency shall: (1) Apply for participation in the Program using the form designated by the Department; (2) Be approved for participation by the Department; (3) Have in effect a provider agreement with the Department; (4) Accept payment by the Department as payment in full for covered services rendered and make no additional charge to any person for covered services; (5) Provide verification to the Department, in the manner prescribed by the Department, of all changes in the provider's charges within 10 days of the occurrence of the changes; (6) Maintain all patient care, medical supply, timesheets, official agency recipient or witness signature records, and billing records for a minimum of 6 years after completion of an audit by the Department and make them available, upon request, to the appropriate State and federal personnel or their designees during office hours; (7) Secure from the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner a written plan of treatment which relates the items and services to the participant's medical condition; (8) Maintain a participant's plan of care based on the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment for the participant; (9) Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap; (10) Verify the participant's eligibility; (11) Place no restriction on a participant's right to select his choice of providers under this subtitle; (12) Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the participant; (13) Agree that if the Program denies payment due to late billing, the provider may not seek payment from the participant; (14) Provide services in person unless expressly authorized by the Department to render services via telehealth; and (15) If not rendering services in person, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. C. Plan of Treatment. (1) The plan of treatment under §B(8) shall include: (a) Prognosis; (b) Diagnoses; (c) Treatment goals; (d) Frequency of visits for each type of service ordered; (e) Duration of treatment of each type of service ordered; (f) Rehabilitation potential; (g) Functional limitations; (h) Permitted and prohibited activities; (i) Diet; (j) Medications; (k) Treatments; (l) Mental status; (m) Medical supplies; (n) Durable medical equipment; (o) Safety measures to protect against injury; and (p) Other appropriate items. (2) The plan of treatment shall be reviewed, updated, and signed at least every 60 days by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner, in consultation with the registered nurse or the case coordinator. (3) The physician, physician assistant, certified nurse midwife, or certified nurse practitioner shall: (a) Sign and date the initial plan of treatment; and (b) Document that the physician or nonphysician practitioner, who is not employed by the home health agency, has had a face-to-face encounter with the participant no more than 90 days before the home health start of care date or within 30 days of the start of the home health care, including the date of the encounter. (4) For participants admitted immediately to home health upon discharge from a hospital or post-acute setting, the attending acute or post-acute physician shall document the clinical findings of the face-to-face encounter. (5) The plan of treatment shall be part of the provider's permanent record for the participant. D. Plan of Care. (1) For each type of service ordered, the plan of care under §C(9) shall, at a minimum, include: (a) Goals of treatment; (b) Actions or procedures needed to meet the goals; (c) Dates the goals are expected to be achieved; (d) Problems encountered, if any; (e) Revision of goals and actions or procedures, whenever necessary; and (f) Appropriate discharge activities. (2) The plan of care shall be reviewed, dated, and signed at least every 60 days by the registered nurse or the case coordinator upon consultation with the appropriate health team. (3) The plan of care is a part of the provider's permanent record for the participant. #### Regulation .04 Covered Services. *COMAR 10.09.04.04* A. The Program covers the services listed in §§B and C of this regulation when the services are: (1) Provided upon the written order of a physician, physician assistant, certified nurse midwife, or certified nurse practitioner; (2) Furnished under the current plan of treatment; (3) Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service; (4) Consistent with the current diagnosis and treatment of the participant's condition; (5) In accordance with accepted standards of medical practice; (6) Required by the medical condition rather than the convenience or preference of the participant; (7) Considered under accepted standards of medical practice to be a specific and effective treatment for the participant's condition; (8) Required on a part-time, intermittent basis; (9) Rendered in the participant's home, or other setting when normal life activities take the participant outside the home, by an approved provider; (10) Received by the participant as documented by the participant's signature or the signature of the participant's witness on the home health agency's official forms; and (11) Adequately described in the signed and dated progress notes. B. The Program covers the following services: (1) Skilled nursing services provided by a licensed nurse when the complexity of the services, or the condition of a participant, requires the judgment, knowledge, and skills of a licensed nurse; (2) Home health aide services provided by a home health aide, that include: (a) Assistance with activities of daily living as defined in Regulation .01B of this chapter when performed in addition to other home health services; (b) Other health care services properly delegated by the registered nurse pursuant to the Maryland Nurse Practice Act as set forth in Health Occupations Article, Title 8, Annotated Code of Maryland, that may include, but are not limited to: (i) Noninvasive parts of ostomy or catheter care; (ii) Nonsterile dressing changes; (iii) Procedures; (iv) Exercises; (c) Reporting of the participant's condition and needs; and (d) Completion of appropriate records; (3) Physical therapy services, provided by a physical therapist: (a) When the condition of a participant requires the judgment, knowledge, and skills of a licensed or registered physical therapist; (b) When the services are directly related to the physician's, physician assistant's, certified nurse midwife's, or certified nurse practitioner's plan of treatment, which specifies: (i) Body part or parts to be treated; (ii) Type of modalities or treatments to be rendered; (iii) Expected results of physical therapy treatments; (iv) Frequency and duration of treatment; (c) When the services are of a diagnostic, rehabilitative, or therapeutic nature and: (i) Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in physical functioning in a reasonable and generally predictable period of time; or (ii) Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state; (4) Occupational therapy services, provided by an occupational therapist: (a) When the condition of the participant requires the judgment, knowledge, and skills of a licensed occupational therapist; (b) When the services are provided with the expectation that there will be a significant practical improvement in a participant's level of physical functioning within a reasonable period of time; and (c) When the services fall within one or more of the following categories: (i) Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests; (ii) Selection and teaching of task-oriented therapeutic activities designed to restore physical function; (iii) Teaching of compensatory techniques to improve the level of independence in the activities of daily living; (iv) Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance; (v) Improvement of mobility skills; and (5) Speech-language pathology services performed by a licensed speech-language pathologist when the: (a) Services are of a diagnostic, rehabilitative, or therapeutic nature and: (i) Are provided with the expectation, based on the assessment made by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner, that a participant will improve significantly in a reasonable and generally predictable period of time; or (ii) Are necessary to the establishment of a safe and effective maintenance program required in connection with a specific disease state; and (b) The condition of a recipient requires the judgment, knowledge, and skills of a speech-language pathologist. C. The Program covers a provider's newborn early discharge assessment visit to a participant when the assessment: (1) Is 4 hours or less; (2) Is ordered by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner; (3) Is delivered to a participant and a participant's mother who have been discharged within 48 hours after delivery; (4) Occurs within 36 hours after discharge; (5) Includes: (a) An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant; (b) An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse physical symptoms of the mother; (c) Collection of a blood specimen for newborn screening as described in COMAR 10.52.12; (d) An evaluation of risk factors that identify biological factors for the infant, maternal health behaviors, psychosocial environmental problems, or any other concerns or problems perceived by the nurse that are identified on a form specified by the Department; and (e) Referrals for any continuing health care services, including skilled nursing services under COMAR 10.09.53 or home health services under this chapter; and (6) Is conducted by a registered nurse. D. A provider may deliver services in §B of this regulation via telehealth if: (1) The Department expressly authorizes the provider to render services via telehealth; and (2) The patient's plan of care specifies that the service may be delivered via telehealth. #### Regulation .05 Limitations. *COMAR 10.09.04.05* The Program does not cover the following: A. Nonskilled services rendered by licensed nurses, physical therapists, occupational therapists and speech pathologists; B. Services and medical supplies that are not medically necessary and appropriate; C. Durable medical equipment except as covered under COMAR 10.09.12; D. Services primarily for the purpose of housekeeping, including but not limited to: (1) Cleaning of floor and furniture; (2) Laundry; and (3) Shopping; E. Home health aide services unless biweekly supervisory visits by a registered nurse in the participant’s home are made, every second visit of which shall include observations of the delivery of services by the aide to the participant; F. Home health aide services rendered to participants with chronic conditions when those participants require only assistance with activities of daily living as defined in Regulation .01B of this chapter unless preauthorized as specified in Regulation .06 of this chapter; G. Meals; H. More than one visit per type of service per day, unless preauthorized as specified in Regulation .06 of this chapter; I. Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which payments by the Program to the provider exceed the Medicaid average nursing facility rate unless preauthorized as specified in Regulation .06 of this chapter; J. Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day unless preauthorized as specified in Regulation .06 of this chapter; K. Services for investigational and experimental purposes; L. Services specified in Regulation .04 of this chapter to persons eligible for Medicare coverage of those services; M. A service not documented as received by the participant as indicated by the participant’s signature or the signature of a witness on the home health agency's official form; N. Supervisory visits by a registered nurse to monitor services of a home health aide; O. Initial assessments by a therapist or a registered nurse; P. Services provided for the convenience or preference of the participant or primary caregiver rather than as required by the participant’s medical condition; Q. Services specified in Regulation .04 of this chapter which duplicate or supplant services performed by the participant and those services rendered by the participant’s family; R. Services which are covered by other insurance or entitlement programs; S. Newborn early discharge services provided more than one time to a participant; T. A newborn early discharge visit provided on the same day as another skilled nursing visit billed under this chapter; and U. Home health services ordered by an: (1) Individual who is not enrolled as a provider in the Program with an active status on the date of service; and (2) Entity, facility, or another provider that is not an individual. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.04.06* A. Preauthorization is required for: (1) More than one visit per type of service per day; (2) Any service or combination of services specified in Regulation .04 of this chapter and rendered during any 30-day period for which the provider anticipates payments from the program in excess of the Medicaid average nursing facility rate; (3) Four or more hours of care per day whether the 4-hour limit is reached in one visit or in several visits in one day; and (4) Any instances in which home health aide services without skilled nursing services are provided. B. Preauthorization may be: (1) Issued by telephone when the provider submits to the Department or its designee adequate documentation demonstrating that the service or services are medically necessary. (2) Denied when the Department, after taking into consideration the particular circumstances of the participant, determines the payments to the provider for any service or combination of services rendered during any 30-day period would exceed the cost to the program of any alternative services which could be used for the same purpose. #### Regulation .07 Payment Procedures. *COMAR 10.09.04.07* A. The provider shall submit his request for payment on the form designated by the Department. B. To receive payment for services under Regulation .04 of this chapter, a provider and its workers shall use the Electronic Visit Verification method and data management system approved by the Department to document time and submit claims in accordance with COMAR 10.09.36.03-2. C. The provider shall submit requests for payment for supplies on the same invoice which requests payment for the visit during which the supplies were used. D. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. E. Payment Rates. (1) The provider shall be paid the lesser of: (a) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rate in accordance with the Department's fee schedule. (2) For out-of-State providers, rates shall be paid at the lower of the following: (a) The home state's Medicaid rate for the same service rendered by the same provider if the provider participates in its home state Medicaid Program; or (b) The rate paid for the same service rendered by a provider in the nearest Maryland county. (3) The Department shall pay home health providers for medical and other supplies which are used during a covered home health visit as part of the treatment ordered by the participant's physician, physician assistant, certified nurse midwife, or certified nurse practitioner at a rate that is the lesser of the: (a) Provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) Medicaid rate for the supply or pharmaceutical under COMAR 10.09.12 and 10.09.03. (4) Subject to the limitations of the State budget, the fee schedule rates shall be adjusted annually by the same factor used by the Centers for Medicare and Medicaid Services in updating Medicare's prospective payment system rates. The annual fee schedule rate adjustment shall be limited to a maximum of 5 percent and be effective the date on which Medicare's rate changes are implemented. (5) The fee schedule effective January 1, 2025 is as follows: F. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. G. The Department shall reimburse for supervision of home health aide services by a registered nurse as part of the home health aide reimbursement. H. Payment to a provider of newborn early discharge services may not exceed the rate for one skilled nursing visit. I. The Department shall reimburse for preauthorized home health services upon verification that a face-to-face encounter with the participant was performed as described under Regulation .03C of this chapter. J. The home health provider shall identify the individual who ordered the home health services by recording the individual practitioner's National Provider Identifier (NPI) number on the claim. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.04.08* Recovery and reimbursement regulations are set forth in COMAR 10.09.36. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.04.09* Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36. #### Regulation .10 Appeal Procedures. *COMAR 10.09.04.10* Appeal procedures are set forth in COMAR 10.09.36. #### Regulation .11 Interpretive Rule. *COMAR 10.09.04.11* State regulations are interpreted as set forth in COMAR 10.09.36. ### Chapter 05 — Dental Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1976 (2:29 Md. R. 1740) **Administrative History:** Regulations .01—.10 amended effective October 13, 1976 (3:21 Md. R. 1206) **Administrative History:** Regulations .01I, .04A, .05, and .06B amended as an emergency provision effective February 1, 1982 (9:2 Md. R. 110); emergency status extended at 9:11 Md. R. 1122 and 9:17 Md. R. 1697 (Emergency provisions are temporary and are not printed in COMAR) **Administrative History:** Regulation .06C adopted effective April 4, 1980 (7:7 Md. R. 708) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .07F amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended to June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) **Administrative History:** Regulation .07L amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Chapter revised effective January 1, 1983 (9:25 Md. R. 2480) **Administrative History:** Regulations .01, .04, and .05 amended as an emergency provision effective December 2, 1992 (19:26 Md. R. 2282); amended permanently effective June 1, 1993 (20:10 Md. R. 851) **Administrative History:** Regulation .01B amended effective October 1, 1985 (12:19 Md. R. 1848); August 27, 2007 (34:17 Md. R. 1507); May 19, 2008 (35:10 Md. R. 972) **Administrative History:** Regulation .01B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787); March 30, 2015 (42:6 Md. R. 511); March 14, 2016 (43:5 Md. R. 385); August 14, 2017 (44:16 Md. R. 808); May 20, 2019 (46:10 Md. R. 485); November 15, 2021 (48:23 Md. R. 979); July 10, 2023 (50:13 Md. R. 512); October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .02 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .02 amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .02C amended effective October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .02D amended effective May 19, 2008 (35:10 Md. R. 972) **Administrative History:** Regulation .02E amended effective May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .02F amended effective August 14, 2017 (44:16 Md. R. 808) **Administrative History:** Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .03 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 485); July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .03B amended effective May 19, 2008 (35:10 Md. R. 972) **Administrative History:** Regulation .03E amended effective November 15, 2021 (48:23 Md. R. 979); October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .03F adopted effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .03F amended effective March 14, 2016 (43:5 Md. R. 385); August 14, 2017 (44:16 Md. R. 808) **Administrative History:** Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .04 amended effective May 19, 2008 (35:10 Md. R. 972) **Administrative History:** Regulation .04 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .04 amended effective August 14, 2017 (44:16 Md. R. 808); May 20, 2019 (46:10 Md. R. 485); November 15, 2021 (48:23 Md. R. 979); July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulations .04A, .05A, and .07E amended, and .07N adopted as an emergency provision effective February 1, 1989 (16:3 Md. R. 336); adopted permanently effective June 1, 1989 (16:10 Md. R. 1108) **Administrative History:** Regulation .04B amended effective October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .04C amended effective December 27, 2010 (37:26 Md. R. 1787); March 30, 2015 (42:6 Md. R. 511) **Administrative History:** Regulation .05 amended effective October 1, 1985(12:19 Md. R. 1848); May 19, 2008 (35:10 Md. R. 972) **Administrative History:** Regulation .05 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .05 amended effective May 20, 2019 (46:10 Md. R. 485); October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .05A amended effective August 14, 2017 (44:16 Md. R. 808) **Administrative History:** Regulation .05B amended effective November 15, 2021 (48:23 Md. R. 979) **Administrative History:** Regulation .05C repealed effective July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .06 amended effective May 19, 2008 (35:10 Md. R. 972) **Administrative History:** Regulation .06 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .06 amended effective November 15, 2021 (48:23 Md. R. 979) **Administrative History:** Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .06B amended effective October 1, 1985 (12:19 Md. R. 1848); December 24, 1990 (17:25 Md. R. 2907); July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .06D amended effective August 14, 2017 (44:16 Md. R. 808) **Administrative History:** Regulation .06F amended effective December 27, 2010 (37:26 Md. R. 1787); March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .07 amended effective October 1, 1985 (12:19 Md. R. 1848) **Administrative History:** Regulation .07 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1381); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) **Administrative History:** Regulation .07 amended effective May 19, 2008 (35:10 Md. R. 972) **Administrative History:** Regulation .07 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .07 amended effective December 27, 2010 (37:26 Md. R. 1787); May 20, 2019 (46:10 Md. R. 485); July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .07D, F, G amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1811) **Administrative History:** Regulation .07E amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .07E amended effective April 20, 1998 (25:8 Md. R. 596) **Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1396); amended permanently effective October 30, 2000 (27:21 Md. R. 1976) **Administrative History:** Regulation .07E amended as an emergency provision effective October 1, 2001 (28:23 Md. R. 2052); adopted permanently effective January 21, 2002 (29:1 Md. R. 23) **Administrative History:** Regulation .07E amended as an emergency provision effective March 25, 2004 (31:8 Md. R. 643); amended permanently effective June 21, 2004 (31:12 Md. R. 911) **Administrative History:** Regulation .07E amended effective August 15, 2005 (32:16 Md. R. 1392); August 27, 2007 (34:17 Md. R. 1508); March 30, 2015 (42:6 Md. R. 511); October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .07E, G amended effective August 27, 2018 (45:17 Md. R. 803) **Administrative History:** Regulation .07E, I amended effective November 15, 2021 (48:23 Md. R. 979) **Administrative History:** Regulation .07E, I, K amended effective August 14, 2017 (44:16 Md. R. 808) **Administrative History:** Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07L amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .08 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1381); amended permanently effective November 1, 1992 (19:21 Md. R. 1890) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029); August 14, 2017 (44:16 Md. R. 808) **Administrative History:** Regulation .09 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .09D amended effective August 14, 2017 (44:16 Md. R. 808) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .10 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .10 amended effective October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .11 amended effective August 14, 2017 (44:16 Md. R. 808) #### Regulation .01 Definitions. *COMAR 10.09.05.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adverse action” means any action taken by the DASO to deny, reduce, terminate, delay, or suspend a covered service. (2) “Aftercare” means the period of follow-up care after initial services are rendered, during which any additional related services rendered by the same provider are included in the payment for the original services. (3) “Ambulatory surgical center (ASC)” means any Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. (4) “Appeal” means the process: (a) To resolve a participant's dispute with any adverse action taken by the DASO to deny, reduce, terminate, delay, or suspend a covered service; and (b) Governed by: (i) COMAR 10.01.04; and (ii) Any and all applicable court orders. (5) “Benefits” means a schedule of dental services to be administered by the DBA to Medical Assistance participants pursuant to this chapter. (6) “Brick and mortar dental office” means the fixed and permanent location where the mobile dental unit: (a) Is linked through either ownership or a legally binding contract; and (b) Transmits participant records. (7) “Claim” means an itemized statement requesting payment for services rendered by health care providers, such as dentists, billed: (a) Electronically; (b) Through a web-based portal; or (c) Manually on the American Dental Association (ADA) claim form. (8) “Consultation” means written opinion or advice rendered by a dentist, upon request by the patient's attending physician or dentist, for the further evaluation or management of the patient by the attending physician or dentist. If the consultant dentist assumes responsibility for the continuing care of the patient, a subsequent service rendered by the consultant is not a consultation. (9) “Dental Administrative Services Organization (DASO)” means an entity with which the Department contracts to administer dental benefits by performing some or all of the following functions: (a) General administration; (b) Regulatory compliance; (c) Network administration; (d) Member services; (e) Claims administration; (f) Data reporting and analysis; (g) Medical management; or (h) Quality monitoring. (10) “Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession. (11) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq., or the Department's designee. (12) “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means comprehensive and preventive health care pursuant to 42 U.S.C. §1396d(e) as amended by OBRA 1989. (13) “Emergency services” means services necessary for the treatment of any condition requiring immediate attention for the relief of pain, hemorrhage, acute infection, or traumatic injury to the teeth, supporting structures (that is, periodontal membranes, gums, and alveolar bone), the jaws, and tissues of the oral cavity. (14) “EPSDT certified provider” means a physician, physician assistant, or nurse practitioner certified by the Department to provide EPSDT services. (15) “Free-standing clinic” means a health care facility approved for participation in the Maryland Medical Assistance Program that is not licensed as a hospital or as part of a hospital or nursing home and that is not administratively part of a health maintenance organization or physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of the clinic administrator (as defined in 42 CFR §405.1801) or a health officer and which is organized and operated to provide clinic services. (16) “General supervision” has the meaning stated in COMAR 10.44.21 and 10.44.27. (17) “Hospital” has the meaning stated in Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland. (18) “Maryland Healthy Smiles Dental Program” means the Maryland Medicaid dental program. (19) “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (20) “Medically necessary” means that a service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice, dental practice, or both; (c) The most cost effective service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (21) “Medicare” means the insurance program administered by the Federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 et seq. (22) “Mobile dental unit” means any self-contained facility in which dentistry will be provided and which may be moved, towed, or transported from one location to another to provide clinically necessary and appropriate dental care in the unit. (23) “Mobile dental practice” means any practice which provides the necessary and clinically appropriate dental equipment to be delivered to a community based location where dental services will be provided on site. (24) “Network provider” means a health care entity or health care professional that has executed a provider agreement with Maryland Medicaid. (25) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (26) “Preauthorization” means an approval required from the Department or its designee before the provision of dental or oral health care services. (27) “Primary dental office” means the fixed and permanent location where the mobile dental unit: (a) Is linked through either ownership or a legally binding contract; and (b) Transmits participant records. (28) “Program” means the Maryland Medical Assistance Program. (29) “Provider” means: (a) An individual dentist, duly licensed to provide services for participants, or an association, partnership, or an incorporated or unincorporated group of dentists so licensed, that, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number; or (b) An approved dental school whose students are permitted under Health Occupations Article, §4-301(b)(1), Annotated Code of Maryland, to treat dental patients and which, through appropriate agreement with the Department, has been identified as a Program provider by issuance of an individual account number. (30) “Referral” means a transfer of the patient from a physician or dentist to a dentist for diagnosis and treatment of the condition for which the referral was made. The dentist to whom the referral is made will no longer be considered the consultant. (31) “REM” means the fee-for-service managed care program for individuals who have certain rare and expensive health care conditions set forth in COMAR 10.09.69. (32) “Self-ligating braces” means braces which utilize a permanently installed, moveable component to secure the archwire without the use of ligatures. (33) “Traditional comprehensive orthodontic treatment” means a coordinated diagnosis and treatment to improve craniofacial dysfunction or dentofacial deformity which may utilize fixed and removable orthodontic appliances and focus on specific objectives at various stages of dentofacial development. #### Regulation .02 License Requirements. *COMAR 10.09.05.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. A dentist shall be licensed and legally authorized to practice dentistry in the state in which service is provided. C. All dentists and dental hygienists working for a mobile dental unit or mobile dental practice shall be currently licensed and registered with the Maryland Board of Dental Examiners. D. The driver of the mobile dental unit: (1) Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; (2) May not have violations related to the operation of a motor vehicle in the last 3 years; and (3) May not have any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years. E. An EPSDT certified provider shall be: (1) A doctor of medicine licensed and legally authorized to practice in the state in which the service is provided; (2) A nurse practitioner who is licensed and certified to practice in the state in which services are provided; (3) A physician assistant who is licensed to practice in the state in which services are provided; or (4) A local health department, or a federally qualified health center, which has on its staff, and under whose supervision EPSDT services are delivered: (a) A doctor of medicine licensed in the state in which the service is provided; (b) A nurse practitioner licensed and certified in the state in which services are provided; or (c) A physician assistant licensed in the state in which services are provided. F. The provider shall ensure that all X-ray or other radiological equipment is inspected and meets the standards established in COMAR 26.12.01 or other applicable standards established by the state in which the service is provided. G. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services rendered, and: (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. #### Regulation .03 Provider Qualifications and Conditions for Participation. *COMAR 10.09.05.03* A. General requirements for participation in the Program are that a provider shall: (1) Comply with requirements set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. To participate in the Program as a dental provider, a provider shall meet the licensure requirements established in Regulation .02 of this chapter. C. To participate in the Program as an EPSDT certified provider of fluoride varnish services, the provider shall: (1) Have MDH Certification for the Application of Fluoride Varnish; and (2) Meet the following requirements: (a) Be board-certified in one of the following: (i) Pediatrics; (ii) Family practice; or (iii) Internal medicine; (b) Be a licensed physician, physician assistant, or licensed and certified nurse practitioner, delivering primary health care to children and adolescents; or (c) Be a local health department or a federally qualified health center. D. The provider shall: (1) Complete the Dental Provider Application; and (2) Submit verification of the National Provider Identifier (NPI) Number. E. Mobile Dental Unit and Mobile Dental Practice. (1) The mobile dental unit shall provide or arrange for comprehensive dental services with a participating Maryland Healthy Smiles Dental Program provider. (2) The mobile dental unit and mobile dental practice shall be linked through either ownership or a legally binding contract to a brick and mortar dental office that has a permanent and fixed location. (3) The brick and mortar dental office shall participate in the Maryland Healthy Smiles Dental Program. (4) The mobile dental unit and mobile dental practice shall have and utilize the electronic technology that enables the same day exchange of patient records with: (a) The brick and mortar dental office; and (b) If requested, the dental office of the parent or legal guardian's choice. (5) The mobile dental unit and mobile dental practice service area shall be limited to 30 miles in a rural setting and 10 miles in an urban setting from the brick and mortar dental office that the mobile dental unit and mobile dental practice is either owned by or with which the dental office holds a legally binding contract. (6) A mobile dental unit and mobile dental practice shall: (a) Maintain dental records for the patient; (b) Observe all patient rights; (c) Obtain written, informed consent from a parent or legal guardian, which shall: (i) Be renewed each school year before treating a minor; and (ii) Allow the parent or legal guardian to request that the dental records be sent to a provider of their choice; (d) Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating: (i) Equipment; (ii) Flammability; (iii) Construction; (iv) Infection control; (v) Sanitation procedures; and (vi) Zoning; (e) Comply with the statutes and regulations of the Maryland Department of the Environment for all dental radiographic and imaging equipment; (f) Obtain, keep current, and make readily available all applicable county and city licenses or permits necessary to operate the mobile dental unit or mobile dental practice which would include the active dentist, hygienist and dental assistant licenses and the dental radiographic and imaging equipment permits; (g) Provide an update to the Department regarding any mobile dental unit or mobile dental practice provider changes within 72 hours; (h) Provide access to a ramp or a lift if services are provided to disabled individuals; (i) Have ready access to a properly functioning sterilization system; (j) Have ready access to an adequate supply of potable water, including hot water; (k) Have immediate access to toilet facilities; (l) Have an appropriately covered noncorrosive metal container for refuse and waste materials; (m) Have carbon monoxide and smoke detection devices or systems installed and in proper working condition; (n) Have a chair designed and purposed exclusively for the provision of dental services; (o) Have a dental treatment light; (p) Have a radiograph unit with appropriate processing equipment; (q) Have an evacuation unit suitable for dental surgical use; (r) Have written procedures for medical emergencies; (s) Have appropriate equipment to treat medical emergencies; (t) Have appropriate and sufficient dental instruments and infection control supplies; and (u) Have any other equipment or system that is necessary to provide the services being rendered by the mobile dental unit or mobile dental practice. (7) Dental hygienists or dental assistants may not solely operate a mobile dental unit or mobile dental practice. (8) The owner or owners of a mobile dental unit or mobile dental practice shall submit a business plan to the dental administrative service organization for the mobile unit or mobile dental practice that includes: (a) The mission of the mobile dental unit and mobile dental practice; (b) Verification of ownership of the mobile dental unit and mobile dental practice; (c) A list of the clinical practitioners that will render services in the mobile dental unit or mobile dental practice; and (d) The targeted population. #### Regulation .04 Covered Services. *COMAR 10.09.05.04* A. The Program covers medically necessary dental services for participants younger than 21 years old and eligible former foster care participants younger than 26 years old, including but not limited to the following: (1) Emergency, preventive, diagnostic, and treatment services; (2) Semiannual cleaning, fluoride treatment and examination; (3) Pit and fissure sealants for the occlusal surfaces of posterior permanent teeth that are without decay; (4) Orthodontic care for conditions which: (a) Have adjusted case scores of at least 15 points on the Handicapping Labio-Lingual Deviations Index (HLD) Table No. 4; and (b) Cause dysfunction due to a handicapping malocclusion that is supported by comprehensive pretreatment orthodontic records, which include at a minimum: (i) Cephalometric head film with analysis; (ii) Panoramic or full series periapical radiographs; (iii) Extra-oral and intra-oral photographs; (iv) Clinical summary with diagnosis; (v) HLD score sheets from attending orthodontist; and (vi) Treatment plan; (5) Consultations for participants who meet the requirements of §A(1), (2), (3), or (4) of this regulation; (6) Drugs dispensed or injectable drugs administered by the dentist within the limitations of COMAR 10.09.03; (7) Oral Health assessment by an EPSDT certified provider, and if determined medically necessary, the application of fluoride varnish for children 9 months old through 5 years old; (8) General anesthesia during dental procedures, when it is medically necessary; and (9) Fluoride varnish. B. The Program covers the following medically necessary dental services for participants 21 years old or older: (1) Periodic, limited, and comprehensive oral examinations; (2) X-rays, including: (a) First and each additional intraoral periapical film; (b) Single, two, three, or four film bitewings, which are limited to: (i) Two per patient per year for REM participants 21 years old or older; or (ii) One per patient per year for pregnant participants 21 years old or older; and (c) One panoramic radiographic image every 36 months; (3) Prophylaxis for adults, which is limited to: (a) One per patient per 3 months for REM participants 21 years old or older; or (b) Two per patient per 12 months for adults ages 21 and over; (4) Topical application of fluoride, which is limited to: (a) One application per patient per 6 months for REM participants 21 years old or older; or (b) One application per patient per year for pregnant and postpartum participants 21 years old or older; (5) Amalgam restorations for permanent teeth for one, two, three, four, or more surfaces, which are limited to one identical restoration per tooth per 24 months; (6) Resin restorations for anterior permanent teeth for one, two, three, four, or more surfaces or involving incisal angle, which are limited to one identical restoration per tooth per 24 months; (7) Other restorative services including: (a) Recementing of crowns, which is limited to two times for the same crown; (b) Prefabricated stainless steel crown for permanent teeth; (c) Fillings — sedative, interim or temporary filling; and (d) Pin retention — per tooth, in addition to restoration; (8) Pulp capping, direct and indirect, excluding final restoration; (9) Gingovectomy or gingivoplasty — per quadrant, which is limited to two quadrants per year per patient; (10) Periodontal scaling and root planning — per quadrant; (11) Full mouth debridement, which is limited to one per patient per 2 years, and may not be completed on the same day as prophylaxis; (12) Periodontal maintenance — following active periodontal therapy, which is limited to two per patient per year; (13) Adjustment of complete maxillary and mandibular denture; (14) Adjustment of partial maxillary and mandibular denture; (15) Recementing of bridge, which is limited to two times for the same bridge; (16) Extractions of: (a) Coronal remnants for deciduous teeth; and (b) Erupted tooth or exposed root; (17) Biopsy of oral tissue, hard or soft; (18) Alveoplasty, in conjunction or not in conjunction with extractions — per quadrant; (19) Incision and drainage of abscess intraoral; and (20) Palliative emergency treatment of dental pain that is not associated with recently rendered service. C. The Program shall reimburse for covered services in §§A and B of this regulation if: (1) The services are rendered in: (a) The dentist's office; (b) The participant's home by an approved mobile dental unit; (c) A general acute hospital; (d) A skilled or intermediate care nursing facility; (e) A free-standing clinic; (f) An EPSDT certified provider's office; (g) An approved mobile dental unit or mobile dental practice; (h) A Medicare-certified ambulatory surgical center; or (i) Via telehealth in compliance with COMAR 10.09.49. (2) The services are provided by the dentist or one of the following: (a) Another licensed dentist enrolled with Medicaid in the dentist’s employ; (b) A dental hygienist or dental assistant, provided that the individual rendering the service is: (i) In the dentist's employ or in the employ of a public health program; (ii) Under general supervision of a licensed dentist; and (iii) Within the scope of the individual’s training or certification for the purpose of assisting in the provision of dental services; or (c) An EPSDT certified provider for the purpose of applying fluoride varnish; (3) The services are clearly related to the participant's individual dental care needs as ameliorative, diagnostic, curative, palliative, preventive, or rehabilitative services; and (4) The services are adequately described on the participant's dental care record in accordance with record-keeping practices detailed in COMAR 10.44.30. #### Regulation .05 Limitations. *COMAR 10.09.05.05* A. The Program places the following limitations upon covered services: (1) Reimbursement for a complete radiographic survey or full series of X-rays of the mouth may not be made more frequently than once every 3 years to the same provider, or in the case of a group practice, to any partner or associate of that practice, unless medically necessary or specifically required or requested by the Program. (2) For any traumatic injury case, a provider may be reimbursed for a maximum of four panoramic or other extra-oral radiographs. When services are rendered by members of a group practice or association, reimbursement to the group practice or association shall also be limited to a maximum of four panoramic or other extra-oral radiographs. (3) Endodontic therapies and pulpectomies may not be covered when: (a) Root resorption has started and exfoliation is imminent; (b) Gross periapical or periodontal pathosis is demonstrated on the radiograph; or (c) The general oral condition does not justify endodontic therapy. (4) Reimbursement for crowns will be limited to permanent resin fused to metal crowns, permanent porcelain fused to metal crowns, permanent nonprecious metal (full cast), provisional resin crowns, prefabricated zirconia crowns, and stainless steel crowns. (5) Composite restorations will be covered for all teeth when necessary for the particular conditions of the patient. (6) Replacement dentures for participants who meet the requirements of Regulation .04A(3) of this chapter will be covered only when: (a) Dentures have been lost, broken, or stolen after 1 year of placement; or (b) Adjustment, repair, relining, or rebasing of the patient's present denture does not make it serviceable. (7) Rebasing is included in the 6 months of aftercare following denture placement, and may not be provided more frequently than once every 2 years after that. (8) Reimbursement for endodontic therapy includes all diagnostic tests, preoperative and postoperative radiographs, preoperative and postoperative treatments, pulpotomies and pulpectomies. (9) Reimbursement for a sinus closure will only be made when this service is rendered as a separate procedure and not in conjunction with the removal of a tooth. (10) Separate reimbursement will not be made for cavity liners and office visits, as these procedures are considered to be components of the necessary treatment. These services may not be billed to the participant. (11) The provider may bill for emergency treatment or for the actual dental procedures rendered during an emergency visit, but not for both. (12) Gold restorations, gold crowns, and gold replacement appliances are not covered services. (13) The Program's fee for a complete series of intra-oral radiographs including bitewings, represents the maximum payable for any combination of periapical X-rays and bitewings. (14) Assistant surgeons' services are covered only: (a) As specified in Regulation .07M of this chapter; (b) If the procedures were rendered in a hospital or a Medicare-certified ambulatory surgery center; and (c) If the assistant surgeon is a dentist. B. The Program does not cover: (1) Fixed bridge work; (2) Cosmetic procedures; (3) Inpatient hospital dental or oral health care services rendered during an admission; (4) Services which are investigational or experimental; (5) Local anesthesia as a separate charge; (6) Duplication of dentures; (7) Drugs and supplies dispensed by the dentist which are acquired by the dentist at no cost; (8) Referrals; (9) Diagnostic models as a separate charge; (10) Office visits as a separate service; (11) Immediate dentures; (12) Consultant payments when a member of the house staff of a hospital either requests or provides the consultations or, in the case of a group practice, to any partner or associate of that practice who either requests or provides the consultation; (13) Aftercare services as a separate charge to a provider or, in the case of a group practice, to any partner or associate of that practice; (14) Services when reimbursement is included under another segment of the Program; (15) Unilateral partial dentures replacing fewer than three teeth, excluding third molars; (16) Implants; (17) More than one, per participant per lifetime, of the following services: (a) Traditional comprehensive orthodontic treatment; or (b) Self-ligating braces; and (18) Services rendered without the required preauthorization. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.05.06* A. Preauthorization is issued when: (1) Program procedures are met; (2) Program limitations are met; (3) The provider submits to the Department, adequate documentation demonstrating that the service to be preauthorized is medically necessary; and (4) The participant is eligible for the service. B. Preauthorization is required for the following: (1) Resin fused to metal crown; (2) Porcelain fused to metal crown; (3) Nonprecious metal crown (full cast); (4) Apicoectomies and periradicular services; (5) Certain periodontal services; (6) Complete upper/lower denture; (7) Partial upper/lower denture (including clasps and teeth); (8) Any elective clinical or surgical procedure not listed on the current dental fee schedule; (9) Surgery normally considered cosmetic but qualified by traumatic or pathological causation; (10) Laboratory rebasing of dentures; (11) Addition of teeth or clasps to an existing, functional complete or partial denture; (12) General restorative treatment to be rendered in a hospital; (13) Special periodontal appliances; (14) Apexification and recalcification procedures; (15) Hemisection, including any root removal, including endodontic therapy; (16) Overdenture complete; (17) Overdenture partial; (18) Condylectomy; (19) Meniscectomy; (20) Arthrotomy; and (21) All orthodontic procedures. C. At a minimum, the documentation required when requesting preauthorization for the following services is: (1) A complete radiographic survey of the mouth for: (a) Complete or partial dentures; or (b) Except in the case of special needs children, where sedation would be required for a complete radiograph of the mouth, special periodontal appliances and periodontal therapies; (2) Individual periapical radiographs for: (a) Except in the case of special needs children, where sedation would be required for an individual periapical radiograph or bitewing, endodontic therapy (periapicals and bitewings shall be submitted when the request is for posterior teeth); (b) Apicoectomy; (c) Except in the case of special needs children, where sedation would be required for an individual periapical radiograph, periradicular and apexification or recalcification services; and (d) Full coverage permanent crown restorations (excludes stainless steel and provisional resin crowns); and (3) Full mouth radiographs and a periodontal chart, identifying the depths and locations of the pockets, when periodontal services are requested. D. Except as described in §F of this regulation, preauthorization is valid for dental services when the services are approved and completed within 6 months after the date of the receipt of the preauthorization number from the Program. E. Preauthorization normally required by the Program is waived when the services are covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A—D of this regulation. F. Preauthorization for Orthodontic Treatment. (1) Preauthorization is required for traditional comprehensive orthodontic treatment and for self-ligating braces for the correction of medically necessary conditions, which cause dysfunction due to a handicapping malocclusion. At a minimum the following comprehensive pretreatment documentation shall be submitted: (a) Cephalometric head film with analysis; (b) Panoramic or full series of periapical radiographs; (c) 68 diagnostic quality extra-oral and intra-oral photographs; (d) Clinical summary with diagnosis; (e) HLD score sheets from attending orthodontist; and (f) Treatment plan. (2) Preauthorization for periodic orthodontic treatment is valid for: (a) 24 months for traditional comprehensive orthodontic treatment; or (b) 12 months for self-ligating braces. #### Regulation .07 Payment Procedures. *COMAR 10.09.05.07* A. To obtain compensation from the Department for covered services, the provider shall submit a request for payment on the form designated by the Department with the following data or attachments: (1) If applicable, the preauthorization number shall be inserted in the designated appropriate field on the invoice claim form; (2) If applicable, pathology reports shall be attached to the claim form; and (3) If applicable, comprehensive narratives shall be attached to the claim form for those services that are “By Report”. B. The Department reserves the right to return to the provider, before payment, all invoices not properly signed or completed. C. All prosthetic appliances shall be inserted in the mouth and adjusted before the Program is billed, except when the patient has expired, cannot be located, or refuses to return for completion of treatment. In these cases, the Department will reimburse the provider 80 percent of the maximum State fee for the procedure code for the laboratory bill only. D. The provider shall charge the Program the provider's customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §E of this regulation; and E. The current Maryland Medicaid Dental Services Fee Schedule and Procedure Codes CDT is incorporated by reference, effective January 1, 2024. F. The provider shall be paid the lesser of: (1) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The rate in accordance with the Department's fee schedule. G. The provider may not bill the Department or the participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail or telephone; or (4) Providing a copy of a participant's medical record when requested by another licensed provider on the participant's behalf. H. Reimbursement for Traditional Comprehensive Orthodontic Treatment. (1) The Program shall reimburse for orthodontic treatment for a maximum of 24 periodic visits at an established rate, provided the treatment meets the standards established in COMAR 10.09.05.06F. (2) Orthodontic treatment is a once in a lifetime benefit. I. Reimbursement for Self-Ligating Braces. (1) The Program shall reimburse for: (a) A pre-orthodontic visit; (b) Comprehensive orthodontia; and (c) A maximum of 12 periodic treatment visits at an established rate, provided the treatment meets the standards established in COMAR 10.09.05.06F. (2) When a claim is submitted to the Program for the banding of self-ligating braces, the following documentation shall be submitted with the claim: (a) A photograph of the recipient's oral cavity to confirm the placement of self-ligating braces; and (b) A statement signed by the parent or guardian of the child receiving treatment, acknowledging that: (i) Orthodontic services are a once in a lifetime benefit; and (ii) The participant will not be able to pursue additional orthodontic services from the Medicaid Program at a later date. J. The Department may not make direct payment to nurses, dental assistants, anesthetists, or dental hygienists. K. The Department may not make direct payment to the participant. L. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. M. Those dental clinics licensed as part of a hospital in Maryland may charge and be reimbursed according to rates approved by the Health Services Cost Review Commission (HSCRC) pursuant to COMAR 10.37.03. N. Payment for assistant surgeons' services is a maximum of 20 percent of the listed fee paid to the primary surgeon or the fee as determined by the Program for the treatment rendered. The minimum allowance is $25 or the dentist's charge, whichever is lower. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.05.08* A. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the participant for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.05.09* A. If the Department determines that a provider, dentist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the Program; (2) Withholding of payment by the Department; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. C. The Department shall give to the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. D. Any provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify participants that the provider no longer honors Medical Assistance cards before rendering additional services. #### Regulation .10 Appeal Procedures. *COMAR 10.09.05.10* A. Providers may exercise appeal rights pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The provider may appeal a decision to the Office of Administrative Hearings as specified in COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.05.11* Except when the language of a specific regulation indicates an attempt by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 06 — Adult Residential Substance Use Disorder Services **Authority:** Health-General Article, §§2-104(b), 7.5-204(c), 7.5-205(d), 15-105(b), and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: September 11, 2017 (44:18 Md. R. 865) **Administrative History:** Regulation .02B amended effective April 4, 2022 (49:7 Md. R. 465); October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .03C amended effective April 4, 2022 (49:7 Md. R. 465) **Administrative History:** Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .04A amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .06F adopted effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .07 amended effective December 30, 2019 (46:26 Md. R. 1164); October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .09 amended effective October 16, 2023 (50:20 Md. R. 886); September 16, 2024 (51:18 Md. R. 808) **Administrative History:** Regulation .09C amended effective December 31, 2018 (45:26 Md. R. 1242); December 30, 2019 (46:26 Md. R. 1164); April 4, 2022 (49:7 Md. R. 465) **Administrative History:** Regulation .09D—E amended effective April 4, 2022 (49:7 Md. R. 465); November 24, 2025 (52:23 Md. R. 1138) #### Regulation .01 Scope. *COMAR 10.09.06.01* This chapter governs residential substance use disorder services for adults, effective July 1, 2017. #### Regulation .02 Definitions. *COMAR 10.09.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accrediting body” means an entity approved by the Secretary or the Secretary’s designee, under Health-General Article, §19-2302, Annotated Code of Maryland. (2) “Administrative day” means a day of services rendered to a participant who no longer requires the level of care the provider is licensed to deliver, but still requires the level of care in an ASAM Level 3.3, 3.5, or 3.7 setting. (3) “Administrative service organization (ASO)” means the entity under contract with the Department to provide administrative services to operate the Maryland Public Behavioral Health System. (4) “American Society of Addiction Medicine (ASAM) criteria” means an instrument designed to indicate placement guidelines for admission, continued stay, and discharge of individuals with a substance use disorder. (5) “Assessment” means the process of ascertaining the treatment needs of an individual seeking behavioral health services. (6) “Available” means a staff member is on-site, available by phone, or on call. (7) “Behavioral Health Administration” means the administration within the Department that establishes regulatory requirements that behavioral health providers are to maintain in order to become certified or licensed by the Department. (8) “Certified counselor” means a provider approved by the Board of Professional Counselors and Therapists under COMAR 10.58. (9) “Coordinating aftercare services” means being responsible for assisting participants with resources, appointments, and discharge plans. (10) “Crisis intervention” means the methods used to offer short term immediate help to individuals who have experienced an event that produces mental, physical, emotional, and behavioral distress. (11) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (12) “Discharge plan” means a written description of specific goals and objectives to assist the participant upon leaving treatment. (13) “Documentation” means the written medical record. (14) “Evidence-based practice” means a practice approved by the Behavioral Health Administration that applies to certain clinical or rehabilitative interventions provided by public mental health service providers. (15) “Facility director” means an individual on staff who is responsible for overseeing the daily operation of the residential treatment facility. (16) “Individualized treatment plan” means a written plan that: (a) Addresses the individual’s biopsychosocial needs through goals and objectives; and (b) Is updated as needed according to the treatment modality. (17) “License” means the approval issued by the Secretary or designee that permits a behavioral health provider to operate in Maryland. (18) “Licensed mental health clinician” means a staff member who is eligible to provide mental health services as outlined in COMAR 10.09.59.04A. (19) “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. (20) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (21) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (22) “Participant” census means a record of participants actively in the care of the provider. (23) “Program” means the Maryland Medical Assistance Program. (24) “Progress” note means an objective documentation of the participants progress in relation to specific treatment goals and objectives. (25) “Provider” means a residential treatment facility that provides professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting. (26) “Substance use disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances. (27) “Substance use disorder services” means the services for which a participants diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter. #### Regulation .03 Licensure Requirements. *COMAR 10.09.06.03* To participate in the Program, a provider shall: A. Meet the license requirements stated in COMAR 10.09.36.02 and, after April 1, 2018, COMAR 10.63.01.05; B. Be accredited by a Maryland-approved accrediting body; and C. Be licensed by the Behavioral Health Administration (BHA) for each level of care. #### Regulation .04 Conditions for Participation. *COMAR 10.09.06.04* A. General requirements for participation in the Program are that a provider shall: (1) Comply with requirements set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. To participate in the Program as a residential substance use disorder provider, the provider shall: (1) Be in compliance with COMAR 10.63.03 as applicable to each ASAM level of care; (2) Be in compliance with all ASAM requirements for each applicable level of care; (3) Demonstrate competence in the ability to deliver a minimum of three evidence-based practice services; (4) Complete all required documentation associated with the application process; (5) Maintain verification of licenses and credentials, including background checks, of all professionals employed by or under contract with the provider in their respective personnel files; (6) Maintain staffing within each ASAM level of care as described in §§C—G of this regulation; (7) Increase staffing within each ASAM level of care at a ratio to correspond with the participant census to meet required ASAM level of service delivery for each patient; (8) Maintain adequate documentation of each clinical contact with a participant as part of the medical record, which includes, at a minimum: (a) An individualized treatment plan; (b) The date of all clinical encounters with start and end times and a description of services provided; (c) Documentation of all clinical services received by the participant; (d) Progress notes updated on each day services are provided; (e) An individualized discharge plan; and (f) An official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate degree or title on all clinical progress notes; (9) Maintain adequate documentation indicating that the participant continues to meet the medical necessity criteria for the applicable ASAM level of care; (10) Make the documentation required under this subtitle, or necessary to substantiate compliance with this subtitle, available as requested to carry out required activities, to the: (a) Department; (b) ASO; (c) Core Service Agency; (d) Local addictions authority; (e) Local behavioral health authority; (f) Office of Inspector General of the Department; and (g) Office of the Attorney General Medicaid Fraud Control Unit; and (11) Comply with all federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164.04 Participant Eligibility and Referral. C. A residential, low-intensity level 3.1 provider shall: (1) Provide therapeutic services for a minimum of 5 hours per week; (2) Coordinate aftercare services through: (a) Peer support; or (b) A licensed provider; (3) At a minimum, maintain the following staff: (a) A part-time program director on-site 20 hours per week; (b) A clinical director serving the program 20 hours per week who: (i) May also be the program director; (ii) Is responsible for the supervision of the program’s clinical services, counselors, peer support staff, and coordination of all care provided by outside programs; and (iii) Is identified under COMAR 10.09.59.04 as an individual practitioner provider or certified and approved by the Board of Professional Counselors and Therapists as a supervisor; (c) A licensed or certified counselor on-site 40 hours per week; (d) Peer support staff; and (e) At least one staff member on duty between 11 p.m. and 7 a.m. who is: (i) Certified in cardiopulmonary resuscitation; (ii) Certified in Narcan administration; and (iii) Trained in crisis intervention. D. A residential, medium intensity level 3.3 provider shall: (1) Have sufficient physician, physician assistant, or nurse practitioner services to: (a) Provide initial diagnostic work-up; (b) Provide identification of medical and surgical problems for referral; and (c) Handle medical emergencies when necessary; (2) Provide therapeutic activities from 20 to 35 hours per week; (3) Coordinate aftercare services through: (a) Peer support; or (b) Licensed provider; (4) Have at least one staff member: (a) Certified in cardiopulmonary resuscitation; (b) Trained in crisis intervention; and (c) On duty between 11 p.m. and 7 a.m.; (5) Have a part-time facility director on-site 20 hours per week; and (6) At a minimum, maintain the following staff: (a) A physician, nurse practitioner, or physician assistant on-site 4 hours per week and 1 hour on call; (b) A psychiatrist or psychiatric nurse practitioner available 3 hours per week; (c) A registered nurse or licensed practical nurse on-site 40 hours per week; and (d) An on-site multi-disciplinary team consisting of: (i) A clinical supervisor; (ii) A licensed mental health clinician; (iii) A certified counselor under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and (iv) Peer support staff. E. A residential, high intensity level 3.5 provider shall: (1) Have sufficient physician, physician assistant, or nurse practitioner services to: (a) Provide initial diagnostic work-up; (b) Provide identification of medical and surgical problems for referral; and (c) Handle medical emergencies when necessary; (2) Provide a minimum of 36 hours of therapeutic activities per week; (3) Coordinate aftercare services through: (a) Peer support; or (b) A licensed provider; (4) Have at least one staff member: (a) Certified in cardiopulmonary resuscitation; (b) Trained in crisis intervention; and (c) On duty between 11 p.m. and 7 a.m.; (5) Have a part-time facility director on-site 20 hours per week; and (6) At a minimum, have the following staff: (a) A physician, nurse practitioner, or physician assistant on-site 1 hour per week; (b) A psychiatrist or psychiatric nurse practitioner available 1 hour per week; (c) An on-site multi-disciplinary team consisting of: (i) A clinical supervisor; (ii) A licensed mental health clinician; (iii) Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and (iv) Peer support staff. F. A residential, intensive level 3.7 provider shall: (1) Have sufficient physician, physician assistant, or nurse practitioner services to: (a) Provide initial diagnostic work-up; (b) Provide identification of medical and surgical problems for referral; and (c) Handle medical emergencies when necessary; (2) Provide a minimum of 36 hours of therapeutic activities per week; (3) Coordinate aftercare services through: (a) Peer support; or (b) Licensed provider; (4) Have at least two staff members: (a) Certified in cardiopulmonary resuscitation; (b) Trained in crisis management; and (c) On duty between 11 p.m. and 7 a.m.; (5) Have a part-time facility director on-site 20 hours per week; and (6) At a minimum, have on staff a: (a) Physician, nurse practitioner, or physician assistant on-site 5 hours per week and 2 hours on call; (b) Psychiatrist or psychiatric nurse practitioner available 10 hours per week; (c) Nurse on-site 168 hours per week, with a minimum of 56 hours provided by a registered nurse; (d) On-site multi-disciplinary team consisting of: (i) A clinical supervisor; (ii) A licensed mental health clinician; (iii) Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and (iv) Peer support staff. G. A withdrawal management service level 3.7-WM provider shall: (1) Have a part-time facility director on-site 20 hours per week; (2) Coordinate aftercare services through: (a) Peer support; or (b) Licensed provider; and (3) At a minimum, have on staff: (a) A physician, nurse practitioner, or physician assistant on-site 20 hours per week and 4 hours on call; (b) A psychiatrist or psychiatric nurse practitioner available 8 hours per week; (c) A registered nurse on-site 56 hours per week; (d) A licensed practical nurse on-site 112 hours per week; and (e) An on-site multi-disciplinary team consisting of: (i) A clinical supervisor; (ii) A licensed mental health clinician; (iii) Certified counselors under direct supervision of a counselor approved by the Board of Professional Counselors and Therapists as a supervisor; and (iv) Peer support staff. #### Regulation .05 Participant Eligibility and Referral. *COMAR 10.09.06.05* A participant is eligible for substance use disorder services under this chapter if the participant: A. Is enrolled in the Program and is not enrolled in Medicare on the day a service is rendered; B. Meets the Department’s medical necessity criteria based on the ASAM placement criteria for each level of care; and C. Is 18 years old or older and is not receiving care from a provider under COMAR 10.09.23.04. #### Regulation .06 Covered Services. *COMAR 10.09.06.06* A. A residential, low intensity level 3.1 provider shall provide: (1) Therapeutic substance use disorder services for a minimum of 5 hours per week; and (2) Services in a structured environment in combination with low-intensity treatment and ancillary services to support and promote recovery. B. A residential-medium intensity level 3.3 provider shall: (1) Provide clinically managed substance use disorder treatment 20 to 35 hours per week based on a comprehensive assessment; and (2) Provide services in a structured environment in combination with medium-intensity treatment and ancillary services to support and promote recovery. C. A residential, high intensity level 3.5 provider shall: (1) Provide clinically managed substance use disorder treatment at least 36 hours per week based on a comprehensive assessment; and (2) Provide services in a highly structured environment, in combination with medium-intensity to high-intensity treatment and ancillary services to support and promote recovery. D. A residential-intensive level 3.7 provider shall: (1) Provide medically monitored, intensive substance use disorder treatment at least 36 hours per week based on a comprehensive assessment; and (2) Offer a planned regimen of 24-hour professionally directed evaluation, care, and treatment in an inpatient setting. E. A withdrawal management service level 3.7 provider shall offer 24-hour medically supervised evaluation and withdrawal management. F. The Program shall cover services under this chapter rendered via telehealth in accordance with COMAR 10.09.49 when: (1) Provided by licensed or certified staff; (2) The originating site at which the participant receives the service is the adult residential substance use disorder service site; and (3) Total services rendered via telehealth comprise no more than 50 percent of all clinical services. #### Regulation .07 Limitations. *COMAR 10.09.06.07* The Program does not cover the following in a residential substance use disorder treatment facility for adults: A. Services not medically necessary; B. ASAM Level 2 services by any provider; C. Except for services rendered to individuals in a residential, low-intensity program, ASAM Level 1 services by any provider; D. Services not specified in Regulation .06 of this chapter; E. Services beyond the provider’s scope of practice; F. Investigational and experimental drugs and procedures; G. Services rendered but not appropriately documented; and H. Services not preauthorized as required in Regulation .08 of this chapter. I. Additional services rendered via telehealth when telehealth services comprise more than 50 percent of a participant's weekly clinical services. #### Regulation .08 Authorization Requirements. *COMAR 10.09.06.08* A. The provider shall obtain authorization from the ASO to provide residential substance use disorder services outlined in Regulation .06 of this chapter. B. The ASO agent shall authorize services that are: (1) Medically necessary for the applicable level of service as outlined by ASAM criteria for admission; and (2) Of a type, frequency, and duration that are consistent with expected results and cost-effectiveness. C. No payment shall be rendered for services that have not been authorized by the Department or its designee. #### Regulation .09 Payment Procedures. *COMAR 10.09.06.09* A. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. B. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. C. For dates of service from July 1, 2023 through December 31, 2023, rates for the services outlined in this chapter shall be as follows: (1) For ASAM Level 3.1, the provider shall receive $104.62 per diem; (2) For ASAM Level 3.3, the provider shall receive $233.14 per diem; (3) For ASAM Level 3.5, the provider shall receive $233.14 per diem; (4) For ASAM Level 3.7, the provider shall receive $358.93 per diem; and (5) For ASAM Level 3.7-WM, the provider shall receive $436.38 per diem. D. For dates of service from January 1, 2024 through June 30, 2024, rates for the services outlined in this chapter shall be as follows: (1) For ASAM Level 3.1, the provider shall receive $112.99 per diem; (2) For ASAM Level 3.3, the provider shall receive $251.79 per diem; (3) For ASAM Level 3.5, the provider shall receive $251.79 per diem; (4) For ASAM Level 3.7, the provider shall receive $387.64 per diem; and (5) For ASAM Level 3.7-WM, the provider shall receive $471.40 per diem. E. For dates of service beginning July 1, 2024, rates for the services outlined in this chapter shall be as follows: (1) For ASAM Level 3.1, the provider shall receive $116.38 per diem; (2) For ASAM Level 3.3, the provider shall receive $259.34 per diem; (3) For ASAM Level 3.5, the provider shall receive $259.34 per diem; (4) For ASAM Level 3.7, the provider shall receive $399.27 per diem; and (5) For ASAM Level 3.7-WM, the provider shall receive $485.54 per diem. F. Administrative Days. The Department shall pay at the daily rate based on the patient’s ASAM level of care when: (1) The participant’s required level of care has changed, and the following conditions are met: (a) The provider has implemented a predischarge planning program and initiated placement activities for the participant at the earliest appropriate time; (b) The provider has actively pursued placement of the participant at the required level of care in an appropriate facility during the entire period of administrative days; (c) The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §E(1)(a)—(b) of this regulation for the entire period of the administrative stay claimed for reimbursement; and (d) The participant is transferred promptly to the first available appropriate facility licensed and certified for the required level of care; and (2) The participant is at an inappropriate level of care but cannot be moved, and the following conditions are met: (a) The attending physician has declared that, because of physical or emotional problems, the participant is unable to be moved; and (b) The reason the participant cannot be moved is adequately documented by the attending physician in the participant’s record. #### Regulation .10 Recovery and Reimbursement. *COMAR 10.09.06.10* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .11 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.06.11* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .12 Appeals Procedures. *COMAR 10.09.06.12* Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09. ### Chapter 07 — Medical Day Care Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-111, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1980 (6:26 Md. R. 2073) **Administrative History:** Regulations .03B, C and .07D amended effective March 10, 1986 (13:5 Md. R. 543) **Administrative History:** Regulation .03D adopted effective January 6, 1983 (9:26 Md. R. 2572) **Administrative History:** Regulation .03E adopted and .07A amended effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .07A amended effective June 3, 1985 (12:11 Md. R. 1049) **Administrative History:** Regulation .07F amended as an emergency provision effective July 1, 1983 (10:12 Md. R. 1070); adopted permanently effective September 12, 1983 (10:18 Md. R. 1608) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Chapter revised effective May 1, 1989 (16:8 Md. R. 909) **Administrative History:** Regulations .01B and 07A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulations .03J and K and .09 amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); adopted permanently effective November 1, 1990 (17:21 Md. R. 2529) **Administrative History:** Regulation .09A amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .09A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .09D amended effective July 4, 1994 (21:13 Md. R. 1157); November 24, 2003 (30:23 Md. R. 1651) **Administrative History:** Regulation .09-1 adopted as an emergency provision effective February 1, 2002 (29:4 Md. R. 412); emergency status expired June 30, 2002 **Administrative History:** Chapter revised effective January 14, 2008 (35:1 Md. R. 17) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .01B amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .03 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .03H, I amended effective May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .03H, M amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .03M amended effective April 4, 2011 (38:7 Md. R. 431); May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .04A amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .04A, B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .04B amended effective February 22, 2010 (37:4 Md. R. 340); April 4, 2011 (38:7 Md. R. 431); May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .05 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .05A amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485); May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .06 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .06B amended effective February 15, 2016 (43:3 Md. R. 272); May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .07 amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .08 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); amended permanently effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .08 amended effective October 10, 2016 (43:20 Md. R. 1110) **Administrative History:** Regulation .08B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .08D amended effective April 6, 2009 (36:7 Md. R. 523); February 22, 2010 (37:4 Md. R. 340); October 31, 2011 (38:22 Md. R. 1345); May 20, 2019 (46:10 Md. R. 486); May 18, 2020 (47:10 Md. R. 516)​; November 14, 2022 (49:23 Md. R. 995); October 16, 2023 (50:20 Md. R. 886); November 24, 2025 (Md. R. 52:23 1138) **Administrative History:** Regulation .08-1 adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired August 22, 2008 **Administrative History:** Regulation .09 amended effective April 4, 2011 (38:7 Md. R. 431) #### Regulation .01 Definitions. *COMAR 10.09.07.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Adult Day Care Assessment and Planning System (ADCAPS)” means a system that is comprised of a comprehensive assessment completed by a registered nurse, which is designed to evaluate the participant’s strengths and needs, and to facilitate the development of a problem list, service plan, and plan of care. (2) “Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with the waiver, this chapter, and COMAR 10.09.30, assesses waiver applicants and participants. (3) “Advance directive” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland. (4) “Community Settings Questionnaire” means the participant survey, completed annually or when a participant changes medical day care centers or sites, that is part of the State’s strategy to validate provider compliance with federal requirements on home and community based settings. (5) “Daily attendance record” means a daily attendance account of the physical presence of each medical day care participant that: (a) Is designed by the provider; (b) Is signed and dated by the staff designated to take attendance or by the medical day care director; and (c) Includes the name, medical assistance number, date of service, and arrival and departure times, of each participant, including documentation of time of temporary absences. (6) “Department” means the Maryland Department of Health. (7) “Home and community based services waiver” means a program implemented by the Department and approved by the Secretary of Health and Human Services, which authorizes the waiver of certain specified federal statutory requirements limiting coverage for home and community based services under the Maryland Medical Assistance Program. (8) “Licensed practical nurse” means an individual licensed to practice licensed practical nursing under Health Occupations Article, Title 8, Annotated Code of Maryland. (9) “Licensed social worker” means an individual who is licensed to practice social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (10) “Maintenance services” means the periodic monitoring of medically stable patients and the services provided in order to maintain their health care status. (11) “Medical Assistance Program” means the Program administered by Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients. (12) “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults, who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living. (13) “Medical day care center” means a facility operated for the purpose of providing medical day care services in an ambulatory care setting to medically handicapped adults who do not require 24-hour inpatient care, but, due to their degree of impairment, are not capable of full-time independent living. (14) “Medical director” means an individual who is: (a) Licensed to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland; and (b) Employed by the medical day care center either as a staff member or by a contractual agreement. (15) “Medically handicapped adult” has the meaning stated in Health-General Article, §14-301(c), Annotated Code of Maryland. (16) “Medically necessary” means that a service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (17) “Multidisciplinary team” means the group consisting of members of the medical day care center’s professional staff, the participant, the participant’s authorized representative, health care professionals, and waiver case managers, as appropriate, that establishes and updates the participant’s service plan and plan of care. (18) “Occupational therapist” means an individual who practices occupational therapy under Health Occupations Article, Title 10, Annotated Code of Maryland. (19) “Occupational therapy” means medically prescribed treatment concerned with improving or restoring functions which have been impaired by illness or injury or, when function has been permanently lost or reduced by illness or injury, concerned with improving the individual's ability to perform those tasks for independent functioning. (20) “Participant” means an individual: (a) Who is a medically handicapped adult as defined under §B(14) of this regulation and who is certified by the Department or its designee as requiring nursing facility services, as defined under COMAR 10.09.10, but whose condition does not require institutional care if medical day care services or other services that provide alternatives to institutional care are available; (b) Who is enrolled in a home and community based services waiver that includes medical day care as a waiver service; and (c) Whose disabilities and needs cannot be satisfactorily and totally met in an episodic ambulatory care setting but require participation at least 1 day a week in a day-long rehabilitative or maintenance ambulatory care program which provides a mix of medical and social services and is authorized in the participant’s home and community based services waiver service plan. (21) “Personal care services” means assistance with activities of daily living. (22) “Physical therapist” means an individual licensed to practice physical therapy under Health Occupations Article, Title 13, Annotated Code of Maryland. (23) “Physical therapy” means treatment of disease and injury through use of: (a) Therapeutic exercise and modalities of heat, cold, water, light, electricity, massage and radiant energy (other than roentgen rays, radium or use of electricity for cauterization in surgery); or (b) Administration and interpretation of tests and measurements of neuromuscular and musculoskeletal functions; or (c) Both §B(22)(a) and (b) of this regulation. (24) “Plan of care” means a written plan established by the multidisciplinary team in accordance with COMAR 10.12.04.22, based upon a medical order and an assessment of the participant’s health status and special care requirements. (25) “Preventive services” means those services designed to prevent the occurrence and/or progression of disease at an early stage before complications and serious disabilities develop. (26) “Primary care provider” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant. (27) “Program” means the Maryland Medical Assistance Program. (28) “Provider” means a facility licensed under COMAR 10.12.04 furnishing medical day care services through an appropriate agreement with the Department and identified as a provider by the issuance of an individual account number. (29) “Provider agreement” means a contract between the Department of Health and the provider of medical day care, specifying the services to be performed, methods of operation, financial and legal requirements which shall be in force before Program participation in medical day care. (30) “Recipient” means a person who is certified for, and is receiving, Medical Assistance benefits. (31) “Referral” means to direct a participant, family member, or caretaker to the appropriate community agency or health care provider, or to contact the agency or provider on the participant's behalf, to facilitate access to needed services. (32) “Registered nurse” means an individual licensed to practice as a registered nurse under Health Occupations Article, Title 8, Annotated Code of Maryland. (33) “Secretary” means the Secretary of Health. (34) “Service Plan” means an approved document which specifies the type, amount, frequency, and duration of all waiver and other Medicaid services required to safely support the waiver participant in the community. (35) “Significant change in condition” means a change in the participant’s physical, mental, or psychological status as identified by the comprehensive assessment performed by a registered nurse. (36) “Specially equipped vehicles” means those vehicles used to transport participants with severe physical disabilities that limit mobility. (37) “Supervision” means initial direction or periodic monitoring of the actual activity. #### Regulation .02 Licensing Requirements. *COMAR 10.09.07.02* The provider shall be licensed under COMAR 10.12.04. #### Regulation .03 Conditions for Participation. *COMAR 10.09.07.03* Requirements for providing medical day care services are that the providers shall: A. Meet the licensure requirements as provided in Regulation .02 of this chapter; B. Meet the requirements of COMAR 10.09.36; C. Be open to participants at least 6 hours a day, 5 days a week, and post hours of operation; D. Verify the licenses and credentials for all professionals employed by or contracting with the medical day care center; E. Provide or arrange for the provision of any covered service, as specified in Regulation .05 of this chapter, or any other service which is required by a plan of care; F. Demonstrate to the satisfaction of the Program that a need exists for medical day care in the service area and that the provider has the necessary expertise to deliver the service; G. Have policies and procedures as required under COMAR 10.12.04; H. Maintain medical records for each participant which shall include, as a minimum, the following: (1) An application for admission; (2) The medical day care center's plan of care as required under §M(3)—(4) of this regulation; (3) The current home and community based services waiver service plan or the approved medical day care preauthorization form for the participant; (4) Medical orders for all services rendered which may include, but is not limited to, the: (a) Type and duration of service; (b) Frequency of service; and (c) Dosage and frequency of medications when prescribed; (5) The medical history, chronic illnesses, principal and significant diagnoses, prognoses, prescribed medications, special diets, allergies, and assessments of the recipient's physical and mental status specifying the general types of activities the recipient can and cannot do; (6) The documentation of daily nursing observations for the first 5 days of attendance, and monthly after the first 5 days of attendance; and (7) The initial social history, ADCAPS assessment, and, when needed, social service and activity progress notes; I. Have an emergency plan for each participant which includes, as a minimum, an easily located file on each participant, listing: (1) The name and telephone number of the participant’s primary care provider; (2) The advance directive in accordance with Health-General Article, §5-602, if requested or made by the participant; (3) All allergies identified by the participant or the participant’s primary care provider; (4) The treatments or medications for a participant's conditions; and (5) The name and telephone number of a family member, caregiver, or friend to be notified in case of emergency; J. Provide training for medical day care staff in emergency procedures, including cardiopulmonary resuscitation and first aid; K. Have accurate daily attendance records that are easily retrievable and available for review by the Program; L. Have accurate daily transportation records that are easily retrievable and available for review by the Program, and shall include, as a minimum, each participant's transportation plan; M. Establish a multidisciplinary team who shall: (1) Assess the participant to determine the appropriateness of the medical day care center's care, interventions, and activities; (2) Determine the medical, psychosocial, and functional status of each participant by: (a) Establishing the ADCAPS evaluations on the date of admission; and (b) Completing the assessment with an initial plan of care within 30 days, after which the ADCAPS evaluations shall be conducted every 4 months; (3) Develop an individual plan of care in conjunction with the service plan; (4) Review and update with the participant or participant’s representative, the individual plan of care semi-annually, or more frequently when a significant change in condition is identified or reported; and (5) Obtain the signature of the participant or the participant’s representative to document their approval of the individual plan of care semi-annually, or more frequently when a significant change in condition is identified or reported. N. Have a quality assurance program which includes, as a minimum, health care audits and utilization reviews that: (1) Consist of a review of medical records on all participants that evaluate the appropriateness of admissions, the efficiency, adequacy, and coordination of provided services, and the length of stay and discharge practices, as needed; (2) Include the following elements: (a) Development of outcome criteria for presenting problems common to the medical day care center's participants; (b) Description of actual outcomes as abstracted from the medical day care center's medical records for all the participants served over a specific time period for each presenting problem for which outcome criteria have been developed; (c) Evaluation of actual outcomes compared with the outcome criteria to identify problem areas or reasons for suboptimal care; (d) Documented submission of recommended corrective action to the program director; and (e) Reassessment of the appropriateness of the recommended corrective action as revealed by the outcomes of the next audit; and (3) Is signed and dated by the program director or designee; and O. Have a signed and dated corrective action plan transferring the participant to the appropriate service, if it is determined that the medical day care center's program is not appropriate for an individual participant. #### Regulation .04 Staffing Requirements. *COMAR 10.09.07.04* A. The medical day care center shall have adequate staffing capability to monitor the participants at all times. The composition of the staff depends in part on the needs of the participants and on the number of participants the medical day care center serves. At a minimum, the medical day care center shall meet the requirements of COMAR 10.12.04.14. B. The medical day care center shall also have: (1) A full-time or part-time licensed social worker, who has at least 1 year of experience providing services to adults in a health care setting; and (2) A full-time, part-time, or contractual medical director who: (a) Has 1 year of experience in the care of impaired adults; and (b) May function as the primary care provider for those participants who do not have a primary care provider, consult with staff regarding a participant’s condition and medical needs, and assist with the development of the medical day care center’s health care policies. C. The medical day care center is required under COMAR 10.12.04 to have a director who has a bachelor's degree or is a registered nurse. When the director is not a registered nurse, the center shall designate a health director who is a registered nurse. The health director shall: (1) Establish, develop, and amend the center's health care policies and procedures; (2) Supervise health care services; (3) Manage the delivery of all required health care services to ensure that needed services are provided in a timely manner by appropriate personnel consistent with each individual's plan of care; and (4) Consult with other health care providers to coordinate care, services, and referrals. #### Regulation .05 Covered Services. *COMAR 10.09.07.05* A. The Program reimburses for a day of care which includes the following services: (1) Health care services supervised by the director, medical director, or health director, which emphasize primary prevention, early diagnosis and treatment, rehabilitation and continuity of care, including the following: (a) Participation in the development of the individual participant's plan of care; (b) Participation in the determination of the participant's medical, psychosocial, and functional status; (c) Consultation with the participant’s primary care provider; and (d) Consultation with staff regarding a participant's condition and health care needs; (2) Nursing services performed by a registered nurse or by a licensed practical nurse under the supervision of a registered nurse which include: (a) The evaluation of the needs of the participants for nursing care; (b) The supervision of any nursing staff; (c) Preventive and maintenance services; (d) Observation and monitoring of participant's condition; (e) Rehabilitative services; (f) The teaching and training activities in appropriate self-care techniques; (g) The supervision of medication normally self-administered; (h) The provision of health education; (i) Discharge planning; and (j) Nursing services that may be delegated to other staff in accordance with the Maryland Nurse Practice Act, Health Occupations Article, Title 8, Annotated Code of Maryland; (3) Physical therapy services, performed by or under supervision of a licensed physical therapist, which meet the following conditions: (a) Are of a diagnostic, rehabilitative, therapeutic, or maintenance nature, and are provided with the expectation based on the assessment made by the primary care provider, that a participant will improve significantly in a reasonable and generally predictable period of time, or are necessary for the establishment of a safe and effective maintenance program required in connection with a specific disease state; (b) Are directly related to the primary care provider’s written plan of care which specifies: (i) Part or parts to be treated; (ii) Type of modalities or treatments to be rendered; (iii) Expected results of physical therapy treatments; (iv) Frequency and duration of treatment; (c) The complexity and sophistication of the services, or the condition of a participant, requires the judgment, knowledge, and skills of a licensed physical therapist; and (d) The services are considered within accepted standards of medical practice to be a specified and effective treatment for a participant's condition; (4) Occupational therapy services, performed by an occupational therapist, that meet the following conditions: (a) The treatment requires the special skills of an occupational therapist; (b) The services are directly related to the primary care provider’s written plan of care which specifies the treatment to be rendered, the frequency and duration of treatment, and the expected results of treatment; (c) The treatment is provided with the expectation that there will be a significant practical improvement in a participant's level of functioning within a reasonable period of time; and (d) The services fall within one or more of the following categories: (i) Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests; (ii) Selection and teaching of task-oriented therapeutic activities designed to restore physical function; (iii) Teaching of compensatory techniques to improve the level of independence in the activities of daily living; (iv) Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance according to COMAR 10.09.12; and (v) Improvement of mobility skills; (5) Personal care services which include assistance with activities of daily living such as: (a) Bathing; (b) Eating; (c) Toileting; (d) Dressing; and (e) Ambulation; (6) Nutrition services which include the following: (a) Meals and snacks as specified under COMAR 10.12.04.20; (b) Therapeutic diets as specified under COMAR 10.12.04.20; and (c) Dietary counseling and education; (7) Social work services performed by a licensed, certified social worker or licensed social work associate which include: (a) Screening and interviewing or assisting designated staff with screening and interviewing all referrals to determine the general appropriateness of the prospective participant for the full assessment process and medical day care participation; (b) Ongoing services to include: (i) Identifying the emotional and social needs of participants during the rendering of medical day care services; (ii) Maintaining linkages with community support resources for the participant including relatives, friends, and other care providers; (iii) Counseling to improve the participant's response to the plan of care, chronic condition, and prospects for recovery or stabilization, but does not include diagnosing or treating mental disorders; (iv) Counseling a participant and a participant's family in the availability and utilization of public and private community agency services, referral to, and coordination of these services; (v) Assisting participants in obtaining those health care services which are not available through the medical day care center (such as vision care, podiatry, medical equipment, etc.); (vi) Counseling participants individually to assist with acclimation to the medical day care center's services and to promote active involvement in their plan of care; (vii) Coordinating and implementing group and family counseling in conjunction with plan of care goals; (viii) Writing notes in the participant’s records that reflect the social work activities performed; (ix) Participating in the multidisciplinary team meetings; and (x) Assisting participants with completing the Community Settings Questionnaire; and (c) Discharge planning and referral services including: (i) Written procedures for discharge, referral, and follow-up; (ii) A discharge summary with post discharge goals; (iii) Recommendations for continuing care; and (iv) Referral to appropriate community service agencies and health care providers to facilitate the participant's return to more independent living; (8) Activity programs in accordance with COMAR 10.12.04.15C; and (9) Transportation services that: (a) Are in accordance with COMAR 10.12.04.27; (b) Are provided or arranged for a participant by the medical day care staff; (c) Maximize the following types of transportation services in an effort to achieve the least costly, yet appropriate means of transportation for a participant: (i) Walking, for a person who lives within walking distance of the medical day care center and who is sufficiently mobile; (ii) Family-supplied transportation provided by friends, neighbors, or volunteers; and (iii) Public transportation services; (d) Are procured by the provider after options described in §A(10)(b) of this regulation have been exhausted; (e) Are the responsibility of the provider to: (i) Arrange contractual agreements with transportation providers to meet the transportation needs of the participants; and (ii) Group participants, where possible, in the same taxi, van or specially equipped vehicles, to minimize the cost of transportation; (f) Are provided in accordance with records that clearly indicate both a primary transportation plan and a back-up plan; (g) Are documented, indicating the type of transportation used by each participant; (h) Are scheduled to ensure that a participant's one-way transit time does not exceed 1 hour as specified under COMAR 10.12.04.27; and (i) Are included in the day of care for: (i) Trips and outings which are part of the activities program; and (ii) A participant's medical appointment escorted by center staff. B. The Department shall reimburse for a day of care when this care is: (1) Authorized in the participant's waiver service plan; (2) Medically necessary; (3) Adequately described in progress notes in the participant's medical record, signed and dated by the individual providing care; (4) Provided to a participant certified annually by the Department as requiring nursing facility care as specified under COMAR 10.09.10; and (5) Provided to participants certified present at the medical day care center a minimum of 4 hours a day by an adequately maintained and documented participant register. #### Regulation .06 Limitations. *COMAR 10.09.07.06* A. Medical day care services are not covered for: (1) Individuals who do not meet the definition of “participant” in Regulation .01B of this chapter; and (2) Individuals younger than 16 years old. B. Covered services do not include: (1) Days of service in excess of the frequency specified in the participant’s home and community based services waiver service plan; (2) Services which are not part of those services listed in Regulation .05 of this chapter; (3) Services for a number of participants that exceeds the provider’s licensed capacity on a given day; (4) More than one day of care, per participant, per day; and (5) A day of care provided on the same day that the following services are provided and billed to the Department: (a) Day habilitation services under COMAR 10.09.26; (b) Supported employment services under COMAR 10.09.26; (c) Programs of All-Inclusive Care for the Elderly under COMAR 10.09.44; (d) Senior center plus services under COMAR 10.09.54; (e) Adult day care reimbursed under the State of Maryland's human service contracts; or (f) On-site psychiatric rehabilitation services under COMAR 10.09.59. #### Regulation .07 Authorization Requirements. *COMAR 10.09.07.07* The provider is entitled to reimbursement from the Program when: A. The participant is enrolled in a home and community based services waiver; and B. The service is specified in the participant’s home and community based services waiver service plan. #### Regulation .08 Payment Procedures. *COMAR 10.09.07.08* A. Requests for Payment. (1) All requests for payment of services rendered shall be submitted in accordance with COMAR 10.09.36. (2) Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. B. Payment to a provider shall be limited to the number of days each participant attends the medical day care center, as authorized by a participant’s home and community based services waiver service plan. C. Payment shall be made only to a qualified medical day care provider. Payment may not be made to a participant, or to individual nurses, physicians, social workers, activity coordinators, or aides for services rendered in connection with the provision of medical day care. D. Per Diem Rate. (1) Payment to a medical day care services provider shall be as follows: (a) For dates of service from January 1, 2021 through October 31, 2021, $88.95 per diem; (b) For dates of service from November 1, 2021 through June 30, 2022, $93.58 per diem; (c) For dates of service [on or after] from July 1, 2022 through December 31, 2023, $104.81 per diem; (d) For dates of service from January 1, 2024 through June 30, 2024, $113.19 per diem; and (e) For dates of service on or after July 1, 2024, $116.59 per diem. (2) Subject to the limitations of the State budget, the per diem rate shall increase on July 1 of each year by 4 percent. E. Payment to a provider of medical day care services may not exceed the lesser of the: (1) Per diem rate established under §D of this regulation; or (2) Provider's customary charge to the general public for services covered by the Program, unless the service is free to individuals not covered by Medicaid. F. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §D of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. #### Regulation .09 Recovery and Reimbursement. *COMAR 10.09.07.09* Recovery and reimbursement shall be in accordance with COMAR 10.09.36. #### Regulation .10 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.07.10* Cause for suspension or removal and imposition of sanctions shall be in accordance with COMAR 10.09.36. #### Regulation .11 Appeal Procedures. *COMAR 10.09.07.11* Appeal procedures shall be in accordance with COMAR 10.09.36. #### Regulation .12 Interpretive Regulation. *COMAR 10.09.07.12* State regulations shall be interpreted in accordance with COMAR 10.09.36. ### Chapter 08 — Freestanding Clinics **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: September 14, 1981 (8:18 Md. R. 1479) **Administrative History:** Regulations .03A and .04A amended effective November 23, 1981 (8:23 Md. R. 1856) **Administrative History:** Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .07D, F amended as an emergency provision effective July 1, 1985 (12:14 Md. R. 1426) **Administrative History:** Regulation .07D—H amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1348); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) **Administrative History:** Regulation .07G amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1171); adopted permanently effective October 29, 1984 (11:21 Md. R. 1812) **Administrative History:** Regulation .07N amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulations .01—.11 repealed effective October 1, 1985 (12:19 Md. R. 1849) **Administrative History:** Regulations .01—.11 adopted effective October 1, 1985 (12:19 Md. R. 1849) **Administrative History:** Regulation .01 amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .03A amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .03B amended effective May 28, 1990 (17:10 Md. R. 1219) **Administrative History:** Regulation .04 amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .04A amended effective May 28, 1990 (17:10 Md. R. 1219) **Administrative History:** Regulation .04B amended as an emergency provision effective July 1, 1986 (13:13 Md. R. 1473); adopted permanently effective December 1, 1986 (13:19 Md. R. 2120) **Administrative History:** Regulation .04E amended as an emergency provision effective November 1, 1985 (12:23 Md. R. 2214); adopted permanently effective May 6, 1986 (13:3 Md. R. 271) **Administrative History:** Regulation .04E amended as an emergency provision effective September 2, 1986 (13:22 Md. R. 2394); emergency status extended to April 5, 1987 (14:4 Md. R. 412) **Administrative History:** Regulation .04E amended effective April 6, 1987 (14:7 Md. R. 830); July 1, 1987 (14:13 Md. R. 1473) **Administrative History:** Regulation .04F amended effective January 1, 1989 (15:26 Md. R. 2983) **Administrative History:** Regulation .04G amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .04G amended effective May 28, 1990 (17:10 Md. R. 1219) **Administrative History:** Regulation .05 amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .05E amended effective June 26, 2000 (27:12 Md. R. 1139) **Administrative History:** Regulation .07F amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .07I amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Chapter revised as an emergency provision effective February 1, 1991 (18:7 Md. R. 765); emergency status extended at 18:14 Md. R. 1604 (July 12, 1991); revised permanently effective July 8, 1991 (18:13 Md. R. 1482) **Administrative History:** Regulation .01B amended effective January 20, 1992 (19:1 Md. R. 32); November 20, 1995 (22:23 Md. R. 1801); August 4, 2003 (30:15 Md. R. 991) **Administrative History:** Regulations .01B, .04, .05A, and .08A amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1148); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulations .01 and .05C amended as an emergency provision effective December 23, 1995 (23:2 Md. R. 93); adopted permanently effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .04 amended effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulation .04B amended effective February 17, 2003 (30:3 Md. R. 179); March 5, 2012 (39:4 Md. R. 336) **Administrative History:** Regulation .04D amended effective April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .04E amended as an emergency provision effective April 1, 1992 (19:7 Md. R. 741); amended permanently effective July 1, 1992 (19:12 Md. R. 1135) **Administrative History:** Regulation .04E amended as an emergency provision effective July 15, 1992 (19:16 Md. R. 1468); amended permanently effective December 1, 1992 (19:23 Md. R. 2041) **Administrative History:** Regulation .04E amended effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .05 amended effective November 20, 1995 (22:23 Md. R. 1801); August 4, 2003 (30:15 Md. R. 991) **Administrative History:** Regulation .05C amended as an emergency provision effective October 15, 1992 (19:22 Md. R. 1979); amended permanently effective February 1, 1992 (20:2 Md. R. 112) **Administrative History:** Regulation .05E adopted effective June 26, 2000 (27:12 Md. R. 1139) **Administrative History:** Regulation .05-1 adopted effective August 4, 2003 (30:15 Md. R. 991) **Administrative History:** Regulation .05-1B, C amended effective August 15, 2005 (32:16 Md. R. 1392) **Administrative History:** Regulation .06 amended effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .07I amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) (Recodified to Regulation .09I) **Administrative History:** Regulation .09E amended effective April 4, 2011 (38:7 Md. R. 430) **Administrative History:** Regulation .11C adopted effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .12 amended effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Chapter revised effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .04B amended effective March 5, 2012 (39:4 Md. R. 336) **Administrative History:** Regulation .06G amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulations .01—.13 repealed and new Regulations .01—.14 adopted effective April 1, 2015 (42:6 Md. R. 512) **Administrative History:** Regulation .01B amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .02E amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .03 amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .04D amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .05A amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .05D amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .06 amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .07A, B, D amended effective July 4, 2016 (43:13 Md. R. 712); February 27, 2017 (44:4 Md. R. 252) **Administrative History:** Regulation .09C amended effective October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .10C amended effective February 27, 2017 (44:4 Md. R. 252) **Administrative History:** Regulation .10C, F amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .10F amended effective October 24, 2016 (43:21 Md. R. 1166); October 16, 2023 (50:20 Md. R. 886) **Administrative History:** Regulation .10G amended effective October 16, 2023 (50:20 Md. R. 886) #### Regulation .01 Definitions. *COMAR 10.09.08.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “All-inclusive cost-per-visit rate” means the rate that is established for Federally Qualified Health Centers (FQHCs) which includes all services that are rendered to a participant on a given date of service. (2) “Clinic services” means preventive, diagnostic, therapeutic, rehabilitative or palliative items or services furnished by or under the direction of a licensed physician or dentist either in a freestanding clinic, or outside the clinic if the: (a) Participant does not reside in a permanent dwelling or have a fixed home or mailing address; and (b) Service is provided by clinic personnel. (3) “Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession. (4) “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Direct supervision” means that a physician is: (a) Physically present in the same area of a facility as a nonphysician providing the services required in the physician's plan of care unless standing orders and protocols are provided for physician extenders such as nurse practitioners, nurse midwives, and physician assistants; and (b) Readily available for consultation. (6) “Early and periodic screening, diagnosis and treatment (EPSDT)” means the provision of preventive health care, including medical and dental services under 42 CFR §441.50 et seq. (1981), and COMAR 10.09.23 for assessing growth and development and for detecting and treating health problems in Medical Assistance enrollees younger than 21 years old. (7) “Extraordinary one-time circumstance” means a highly unusual event beyond the control of a federally qualified health center (FQHC), such as an earthquake or flood, which results in an increase in the FQHC's operating costs. (8) Freestanding Clinic. (a) “Freestanding clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. (b) “Freestanding clinic” does not include a clinic or clinic site located in a participant’s home. (9) Home. (a) “Home” means the house, apartment, trailer, licensed health care facility, or other dwelling in which a participant resides. (b) “Home” does not include dedicated commercial space in a high-rise apartment building. (10) “Hospital” means an institution which: (a) Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (b) Is licensed under COMAR 10.07.01 or is licensed by the state in which the service is provided. (11) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (12) “Mental health services” means those services described in COMAR 10.67.08.02 that are rendered to treat an individual for a diagnosis as set forth in COMAR 10.67.08.02M and N. (13) “Out-stationed eligibility worker” means an employee of a federally qualified health center who is responsible for the receipt and initial processing of applications for Medical Assistance for pregnant women, and children born after September 30, 1983, who are younger than 19 years old in accordance with 42 CFR 435.904. (14) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (15) “Patient care policies” means written policies and protocols, describing patient care practices and procedures: (a) Established for the clinic's operation by a group of professional personnel, including one or more physicians affiliated with the freestanding clinic; and (b) Approved by the signature of the clinic's medical director. (16) “Plan of care” means a written plan for the evaluation, treatment, and follow-up of each patient, maintained in the individual's medical record and containing, at a minimum, the following information where applicable: (a) Patient identification data, dates of service, and medical history; (b) Chief complaint, physical findings, and presumptive diagnosis; (c) Plan of treatment; (d) Results of all laboratory tests and diagnostic radiology procedures ordered and performed; (e) Referral to consultant specialist and consultants report; (f) Medications administered and prescribed, with notations indicating quantity, strength, dosage, and refill instructions; and (g) Final diagnoses, other therapy ordered, and follow-up plan. (17) “Preauthorization” means the approval required from the Department or its designee before services can be rendered. (18) “Primary care services” means those medical care services which address a patient's general health needs, including the coordination of the individual's health care with the responsibility for the: (a) Prevention of disease; (b) Promotion and maintenance of health; (c) Treatment of illness; and (d) When appropriate, referral to other specialists for more intensive care. (19) “Program” means the Maryland Medical Assistance Program. (20) “Provider” means a freestanding clinic which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. (21) “Qualified provider” means an individual that meets the definition of a qualified provider under Health-General Article, §§20-103(a) and 20-207, Annotated Code of Maryland. (22) “Rural health clinic” means a facility that meets the definition of a rural health clinic as contained in 42 CFR §491.2(f). (23) “Scope of services change” means a permanent and substantial change in the services or practices of a FQHC that results from one or more of the following: (a) The addition or deletion of a Medicaid-covered FQHC service as described in §1905(a)(2)(B) and (C) of the federal Social Security Act; (b) The addition, elimination, expansion, or reduction of a Health Resources and Service Administration (HRSA) approved FQHC practice location; or (c) A change in costs for out-stationed eligibility worker services. #### Regulation .02 License Requirements. *COMAR 10.09.08.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. A physician or osteopath providing services in a freestanding clinic shall be licensed and legally authorized to practice medicine in the state in which the service is provided. C. The provider shall ensure that all X-ray and other radiological equipment: (1) Is maintained and inspected in compliance with the requirements of the Maryland Radiation Act, Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland; and (2) Meets the standards established by COMAR 26.12.01—26.12.03, or other applicable standards established by the state in which the service is provided. D. The provider shall ensure that a Clinical Laboratory Improvement Amendment (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of: (a) Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and (b) COMAR 10.10.06; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. E. When applicable, abortion clinics shall be licensed in accordance with COMAR 10.12.01. #### Regulation .03 Conditions for Participation. *COMAR 10.09.08.03* A. General requirements for participation in the Program are that a provider shall: (1) Meet all the conditions for participation as set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. Specific requirements for participation in the Program as a freestanding clinic provider require that the provider: (1) Meet the applicable standards and requirements of Regulation .04 of this chapter; (2) Verify the licenses and credentials of all professionals employed by or under contract with the freestanding clinic to provide services; (3) Have clearly defined, written, patient care policies; (4) Maintain adequate documentation of each contact with each participant as part of the plan of care, which, at a minimum, shall include: (a) Date of service; (b) Participant’s chief medical complaint or reason for visit; (c) A brief description of the physical findings and the service provided, including procedures and progress notes; and (d) A legible signature and printed or typed name of professional providing care, with the appropriate title; (5) Have written, effective procedures for infection control under COMAR 10.06.01 Communicable Diseases; (6) Maintain adequate administrative and medical records which are defined as having documentation sufficient in quantity, scope, and detail to confirm that the freestanding clinic services are provided in accordance with this chapter; (7) Be approved by the Medicaid program in the state in which the service is provided; and (8) Provide for in-house program evaluation and clinical record review which assess use of services for appropriateness in meeting client's needs. C. In the absence of specifically applicable regulations, a freestanding clinic shall: (1) Comply with §A of this regulation; (2) Comply with specific conditions, which may be included in the written agreement; and (3) Accept reimbursement according to COMAR 10.09.02 Physicians’ Services. D. Abortion clinics shall provide services in accordance with Health-General Article, §20-209, Annotated Code of Maryland. #### Regulation .04 Covered Services. *COMAR 10.09.08.04* A. The Program covers the services listed in §§B—E of this regulation according to the conditions and requirements indicated. B. Medically Necessary Services. The program covers medically necessary services as described in §§C, D, and E of this regulation and in Regulation .05 of this chapter, rendered to participants by a freestanding clinic, when these services are performed by a physician or by: (1) A registered nurse, a psychologist, or a social worker, provided that the individual performs the service within the scope of the individual’s license or certification for the purpose of assisting in the provision of physicians’ services; (2) A nurse midwife, a nurse practitioner, a licensed practical nurse, or a registered physician’s assistant, provided that the individual performs the services within the scope of the individual's license or certification; or (3) An addictions counselor who meets the requirements in accordance with COMAR 10.58.07. C. Family Planning Clinic Services. (1) To participate in the Program as a family planning clinic, a provider shall meet the requirements of Regulation .03 of this chapter and §§B and C(2) of this regulation and shall: (a) Participate in the Title X: National Family Planning Program; or (b) Provide documented evidence of adherence to and compliance with standards established for family planning by the State of Maryland, Planned Parenthood, or the American College of Obstetricians and Gynecologists. (2) Covered services include: (a) Complete initial and annual physical examination including auscultation of heart and lungs for all patients; (b) Pelvic examination, including bimanual and speculum, and Pap smears on all females annually, unless clinical indication for more frequent examination exists; (c) Laboratory tests including, but not limited to: (i) Hemoglobin or hematocrit, or both, for all patients; (ii) Urinalysis for albumin sugar for all patients; (iii) Sexually transmitted disease (STD) testing for all patients; (iv) Pregnancy testing if indicated by physical examination or history, or both; (v) Rubella titer of all females without documentation of prior rubella immunization which may be done by documented referral to a known provider of this service; (d) Contraceptive methods and devices approved by the Federal Drug Administration, their insertion, filling, or removal, and education on proper use; (e) Rectal examination, if indicated; (f) Basic education regarding human sexuality and reproduction, for all patients; (g) Advice and counseling regarding all family planning methods, including natural family planning measures and sterilization procedures, the availability and effectiveness of methods, procedures involved in each method and untoward effects and potential complications of each method when performed according to §B of this regulation; (h) Sperm count and analysis done on premises or by appropriate documented referral; (i) Sterilizations, including vasectomy, when coded as family planning and when the appropriate forms, as established by Program guidelines, are properly completed and attached to the claim; (j) Post-vasectomy follow-up; and (k) Referral mechanism and documented referral for all patients demonstrating illness, disease, or pregnancy. D. Abortion Clinic Care. (1) To participate in the Program as an abortion clinic, the provider shall meet the requirements of Regulations .02 and .03 of this chapter and §B of this regulation and shall: (a) Meet all applicable state and local requirements for licensure and certification in the state or jurisdiction in which the clinic is located; and (b) Ensure abortions are performed by a qualified provider and in compliance with all applicable Program regulations. (2) Covered services shall include: (a) An abortion procedure for pregnancies which shall include a pelvic examination, and preoperative and postoperative care; (b) Laboratory tests to include pregnancy test, urinalysis for sugar and albumin, hemoglobin or hematocrit, or both, and Rh factor typing; (c) Pap smear; (d) Anesthesia or sedatives or analgesics or any combination of these drugs; (e) Referral to family planning clinic for follow-up family planning; (f) Gross and microscopic tissue examination if there is any doubt in the proper identification of the extracted product of conception concerning composition or completeness; and (g) Obstetrical pelvic ultrasound. E. Rural Health Clinic Services. (1) To participate as a rural health center, the provider shall: (a) Meet the requirements of Regulations .03 and .05A of this chapter; and (b) Be federally certified in accordance with 42 CFR Part 491, Subpart A. (2) Covered services include rural health clinic services as defined in 42 CFR §440.20. (3) The provider shall follow the general rural health center rules and regulations in accordance with 42 CFR §405.2400—42 CFR §405.2417. #### Regulation .05 Federally Qualified Health Center Services. *COMAR 10.09.08.05* A. To participate as a federally qualified health center, the provider shall meet the requirements of Regulations .03 and .04B of this chapter and shall: (1) Meet the conditions for coverage in accordance with 42 CFR §491, Subpart A; (2) Be enrolled in the EPSDT/Healthy Kids Program as provided in COMAR 10.09.23 and provide EPSDT/Healthy Kids services to participants who are eligible to receive them; (3) Supply the Department with financial and other information as requested; (4) Meet one of the following conditions: (a) Meet all of the requirements for receiving a grant under §329, 330, or 340 of the Public Health Service Act, 42 U.S.C. §254(c), as determined by the Secretary of the United States Department of Health, and in accordance with 42 CFR §405.2401; (b) Receive a waiver from the Secretary of the United States Department of Health and Human Services of one or more of the requirements for receiving a grant pursuant to §329, 330, or 340 of the Public Health Service Act; or (c) Be an outpatient health program or facility operated by a tribe or tribal organization under the Indian Self-Determination Act or by an Urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act; (5) Comply with the requirements contained in COMAR 10.09.59 if delivering mental health services and COMAR 10.09.80 when providing substance use disorder services; and (6) Comply with the requirements contained in COMAR 10.09.05, if rendering dental services. B. Covered services are the same as those authorized to be provided by rural health clinics as described in 42 CFR §440.20(b), rural health clinic services, and 42 CFR §440.20(c), other ambulatory services furnished by a rural health clinic. C. In the event that the provider elects to institute a scope of services change, the provider shall: (1) Notify the Department of its intent to institute the scope of services change: (a) Not later than 30 days before it begins to deliver services under the scope of services change; or (b) Within 30 days after the adoption of this section; and (2) Provide the Department with any information the Department needs to: (a) Assure continuity of care for enrollees; (b) Arrange for the processing and payment of claims; or (c) Otherwise administer services to Medical Assistance participants under the provider's scope of services change. D. Rate Revisions for FQHCs Due to Scope of Services Change or Extraordinary One-Time Circumstance. (1) If an FQHC implements a change in the FQHCs scope of services or if the FQHC experiences an extraordinary one-time circumstance, the FQHC or the Department may request a revision of the FQHC's prospective rate of reimbursement. (2) The FQHC shall provide the Department with written notification no later than 30 days after the implementation of the scope of services change or the occurrence of the one-time circumstance. (3) After receiving notification from an FQHC that the FQHC plans to institute a scope of services change, the Department shall notify the FQHC within 30 days if the Department wishes to request a revision to an FQHC's rate. (4) An FQHC or the Department may not request more than one rate revision per FQHC per calendar year under this regulation. (5) When an FQHC or the Department requests a rate revision based on §D(1) of this regulation, the FQHC shall submit to the Department or its designee a cost report and supporting documentation. (6) The cost report and supporting documentation required under §D(5) of this regulation shall: (a) Be submitted within 90 days after the end of the first 1-year period immediately following the implementation of the scope of service change or the occurrence of the extraordinary one-time circumstance; (b) Reflect the change in costs relating to the rate revision request for the center's operations for the first 1-year period immediately following the implementation of the scope of service change or the occurrence of the extraordinary one-time circumstance; (c) Conform with the standards described in §C of this regulation and instructions issued by the Department or its designee; (d) Contain an explanation of the scope of services change or extraordinary one-time circumstance and schedules to support the calculation of the change in the cost-per-visit rate; and (e) Be subject to verification and adjustment by the Department or its designee. (7) Rate revisions granted under this section shall be effective the date the change of scope was approved by the Health Resources and Services Administration (HRSA) or the occurrence of the extraordinary one-time circumstance. (8) The revised rate granted under this section shall be the rate referenced in §A(3) of this regulation. E. Rates of reimbursement established according to this regulation shall be for: (1) Payment of covered services rendered to participants; and (2) Determining supplemental payments under COMAR 10.09.65.21A. #### Regulation .06 Limitations. *COMAR 10.09.08.06* The Program does not cover the following: A. Services not specified in Regulation .04 of this chapter; B. Services not medically necessary; C. Investigational and experimental drugs and procedures; D. Procedures solely for cosmetic purposes; E. Services denied by Medicare as not medically justified; F. Freestanding clinic services for inpatient participants in State-operated facilities serving individuals with intellectual disabilities; G. Freestanding clinic services provided to hospital inpatients; H. Freestanding clinic visits when patients are referred to hospital outpatient departments or emergency rooms for services ordinarily provided in freestanding clinics covered by this chapter; I. Freestanding clinic visits solely for the purpose of one or more of the following: (1) Prescription drugs or collection of laboratory specimens, unless otherwise allowed; (2) Certification or recertification of food supplements; (3) Performing laboratory tests required only for certification or recertification of food supplement programs; (4) Nutritional assessments in the absence of diagnosis of nutritional disorders, unless EPSDT or primary health services are provided at the same time; (5) Ascertaining the patient's weight; (6) Interpretation of laboratory tests or panels; and (7) Measurement of blood pressure; J. Office visits solely for the administration of injectable medications, unless medical necessity and the patient’s inability to take appropriate oral medications are documented in the medical record; K. More than one visit per day to the same freestanding clinic, unless the additional visit is adequately documented as: (1) An emergency situation; or (2) A visit to a different specialty; L. Central nervous system stimulants and anorectic agents when used for weight control; M. Immunizations required solely for travel outside the continental United States; N. Vision care services excluded under COMAR 10.09.14 or COMAR 10.09.23; O. Separate billing for services which are specifically included as part of another service; P. Separate reimbursement to a practitioner for services provided in a freestanding clinic in addition to the freestanding clinic reimbursement; Q. Payment for more than one visit to complete an EPSDT screening service; R. Visits solely for group or individual health education; S. Freestanding clinic visits in addition to an EKG procedure when the EKG procedure is the only purpose for the visit; and T. Services for which preauthorization is required under Regulation .09 of this chapter but has not been obtained. #### Regulation .07 Freestanding Clinic Reimbursement Methodology. *COMAR 10.09.08.07* A. Reimbursement for Family Planning Clinics. The Department shall pay the family planning clinic the lesser of the provider’s customary charge or the provider’s acquisition cost, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with COMAR 10.09.02.07D; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. B. Reimbursement for Abortion Clinics. For dates of service on or after April 1, 2015, the Department shall pay the abortion clinic the lesser of the provider’s customary charge, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with COMAR 10.09.02.07D; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. C. Reimbursement for Rural Health Clinics. The Department shall reimburse rural health clinics in accordance with 42 CFR §447.371. D. The Department shall pay all other freestanding clinics at the lesser of the provider’s customary charge, or the provider’s acquisition cost, but no more than the maximum reimbursement allowed for similar procedures or services required in COMAR 10.09.02.07D. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with COMAR 10.09.02.07D; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. #### Regulation .08 Reimbursement Methodology for FQHC Services. *COMAR 10.09.08.08* A. Federally qualified health centers shall be reimbursed for covered services once the provider is in compliance with all federal and State requirements. B. The only well-child visits that are eligible for Program reimbursement are those that are billed as EPSDT screens. C. Payment of Allowable Costs. (1) Federally qualified health centers shall be paid 100 percent of the FQHC’s allowable costs, subject to the limitations contained in §§D—G of this regulation, that are related to the provision of covered services. (2) Allowable costs will be determined in accordance with Medicare principles of cost reimbursement as contained in 42 CFR 413.5, unless otherwise specified in this chapter. (3) Providers' allowable costs are subject to audit and verification by the Department or its designee. (4) Costs not adequately documented, return on equity, bad debts incurred by private pay, Medicare patients, or third-party payers, and bad debts resulting from denied costs of the Program are not allowable in establishing reimbursement rates. (5) Services covered under §1915(g) of Title XIX of the Social Security Act, which are called targeted case management services, and the costs associated with these services, are excluded when establishing reimbursement rates. D. All-Inclusive Cost-per-Visit Rate. (1) Reimbursement to providers of federally qualified health center services shall be on a per-visit basis. The Department or its designee shall establish an all-inclusive interim and an all-inclusive final cost-per-visit rate for each provider. (2) Each provider shall have a rate established for primary care services. A rate for dental care services shall be established if the service is offered. (3) The all-inclusive cost-per-visit rate for primary care visits covers the allowable costs associated with covered primary care, mental health, and substance abuse services. FQHCs may not charge the program, other than an all-inclusive cost-per-visit rate, for any ambulatory service. (4) The all-inclusive cost-per-visit rate for dental care visits covers only those services that are reimbursed by the Program under COMAR 10.09.05. Other dental services are not reimbursable. (5) Providers' costs, except for those of OB/GYN physicians, for staff who provide radiology services, for off-site visits, and for out-stationed eligibility workers, are divided into the following four cost centers: (a) General service cost center is composed of those costs associated with the depreciation of the facility's building or buildings and equipment, the operation of the plant, the administration and management of the facility, medical records, and those administrative costs associated with pharmacy and EPSDT services which are not reimbursed under a different payment methodology; (b) Primary care services costs are composed of those costs, including supplies, associated with health care staff, including laboratory technicians, who provide direct care to patients; (c) Dental services costs are the costs of supplies and health care staff associated with the provision of dental services to patients; and (d) Non-reimbursable costs are those costs that are not reimbursable under this payment methodology. (6) The interim and final cost-per-visit rates for each service shall be determined by dividing the provider's allowable costs for each service by the total number of visits to the provider for each service. E. Calculation of the Interim All-Inclusive Cost-per-Visit Rate. (1) An interim all-inclusive cost-per-visit rate shall be established for the first 2 years of operation. (2) Providers shall be divided into those located in urban areas and those located in rural areas. Baltimore City and the Maryland counties of Allegany, Anne Arundel, Baltimore, Carroll, Cecil, Charles, Harford, Howard, Montgomery, Prince George's, St. Mary’s and Wicomico are urban areas. (3) All other Maryland counties are rural areas. (4) Providers located out-of-State shall be placed in the same reimbursement class as that of the nearest Maryland county. (5) An interim all-inclusive cost-per-visit rate shall be established for primary care and for dental care services, if applicable, for each provider, by averaging the current FQHC all-inclusive cost-per-visit rate amounts for each area, urban or rural. F. Calculation of the Final All-Inclusive Cost-per-Visit Rate. (1) Following the close of the provider's 2nd fiscal year, the Department or its designee shall determine the final all-inclusive cost-per-visit rate for primary care services and, if offered, for dental care services, for those fiscal years based on the costs stated in the cost report for the 2 fiscal years and subject to the limitations in these regulations. (2) The provider shall submit to the Department or the Department's designee, on the form prescribed, direct and indirect costs and statistical data applicable to patient care. (3) The provider's cost report shall be reviewed in accordance with the standards referenced in §C(1) of this regulation to determine the allowable costs and the number of visits for that cost reporting period. (4) In calculating the final all-inclusive cost-per-visit rates, the limitation on general service cost center costs described in §D(5)(a) of this regulation shall apply. (5) Once the all-inclusive cost-per-visit rate has been determined for each fiscal year, each provider is eligible for additional primary care reimbursement for services rendered by OB/GYN physicians, staff who provide radiology services, off-site visits, and out-stationed eligibility workers. Costs for these additional services are limited to salaries and fringe benefits, including any malpractice insurance, that are paid by the provider. The additional primary care reimbursement shall be calculated by taking the sum of the provider's expenditures for OB/GYN physicians, for staff who provide radiology services, out-stationed eligibility workers, and off-site visits. This sum is divided by the total number of primary care visits. The resulting rate shall be added to the all-inclusive cost-per-visit rate. (6) The final all-inclusive cost-per-visit rate shall be determined by averaging the all-inclusive cost-per-visit rates for the 2 fiscal years and by adding, if applicable, the additional rate for OB/GYN, staff who provide radiology services, or off-site visits. (7) This final all-inclusive cost-per-visit rate shall be implemented retroactively to the start date of the FQHC’s operation. (8) The final all-inclusive rate shall be increased by the Medicare Economic Index (MEI) each calendar year. (9) The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. (10) The provider shall keep all records available for a period of 6 years subject to inspection or audit by the Department or the Department's designee at any reasonable time during normal business hours. G. Cost Reporting. (1) A provider shall submit to the Department or the Department's designee a cost report, and other financial and statistical information requested, within 3 months after the close of the provider's 2nd fiscal year, unless the Department grants the provider an extension or the provider discontinues participation as a federally qualified health center. The following apply: (a) The Program may grant a provider an extension if the provider makes a written request setting forth the specific reasons for the request and the Department determines that the request is reasonable; or (b) If a provider discontinues participation as a federally qualified health center, it shall submit its cost report and other financial and statistical data to the Department within 45 days after the effective date of termination. (2) Cost reports are considered to have been received by the Department or the Department's designee when the submitted reports are completed according to the instructions issued by the Department, or the Department's designee. (3) If a provider's cost report has not been received within 3 months after the close of the provider's 2nd fiscal year or within the deadline set by the Department after an extension has been granted, the Department shall reduce the provider's current interim all-inclusive cost-per-visit rate by 20 percent for visits paid during the calendar month in which the report is due and any subsequent calendar month until the report has been submitted. This amount shall be eligible for repayment to the provider upon final cost settlement for the fiscal year or fiscal years from which the payments were withheld. (4) When a provider's cost report is received by the last day of the 6th month after the end of the provider's 2nd fiscal year and the Department or the Department's designee determines that the final all-inclusive cost-per-visit rate is different than the interim all-inclusive cost-per-visit rate, the increase or decrease is applicable to all reimbursable visits retroactively. (5) The Department or its designee shall notify each provider of the results of the verification of the provider's cost report. (6) The provider may appeal the final cost settlement by following the procedures described in COMAR 10.09.36.09. H. Calculation and Reimbursement of Number of Visits for FQHC Services Rendered to MCO Enrollees. (1) The FQHC shall transmit all of the encounter data to the appropriate MCO. (2) The MCO shall reimburse the FQHC their established all-inclusive cost-per-visit rate for all eligible visits. (3) The FQHC shall have the responsibility of reconciling the number of eligible visits with the MCOs. (4) Each MCO shall transmit all of its FQHC encounter visits to the Department. (5) For an FQHC, the calculation of the number of MCO enrollee visits is as follows: (a) For each 6-month period thereafter, the number of eligible visits received for each period shall be totaled by the Department 12 months after the end of the period; (b) The number of visits reported in §H(5)(a) of this regulation shall constitute the number of visits on which final payments shall be made to each MCO as reported by each FQHC for that 6-month period; (c) The MCO shall receive an interim supplemental payment once every 3 months (quarterly); (d) The interim supplemental payment shall be modified by a final reconciliation of the number of eligible visits applicable to a previous 6-month period received by the Department within 1 year from the end of the 6-month period; and (e) The final payment made to each MCO according to this regulation is not subject to cost settlement. #### Regulation .09 Preauthorization Requirements. *COMAR 10.09.08.09* A. The following procedures or services require preauthorization: (1) Vision care according to COMAR 10.09.14.06 and COMAR 10.09.23; (2) Mental health services which shall comply with the requirements of COMAR 10.09.59; (3) Substance use disorder services which shall comply with the requirements of COMAR 10.09.80; and (4) Dental services which shall comply with the requirements of COMAR 10.09.05. B. The Department or its’ designee shall preauthorize services when the provider submits adequate documentation demonstrating that the service to be preauthorized is medically necessary. C. Preauthorization is valid only for services rendered or initiated within 60 days of the date preauthorization was issued. The patient shall be an eligible participant at the time the service is rendered. D. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment shall be made for services needing preauthorization from the Program only if authorization for those services has been obtained before the services were rendered. #### Regulation .10 Payment Procedures. *COMAR 10.09.08.10* A. The provider shall submit a completed request for payment in the format designated by the Department with any required documentation. B. The Program reserves the right to return to the provider, before payment, all invoices not properly completed with a diagnosis, procedure code, and description of the services provided. C. The provider shall bill the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with COMAR 10.09.02.07D; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. D. The Department shall authorize payment on Medicare cross-over claims only if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that the services are medically necessary; (4) The services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. E. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: (1) A deductible shall be paid in full; (2) Coinsurance shall be paid at the lesser of: (a) 100 percent of the coinsurance amount; or (b) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare, but considered medically necessary by the Program, shall be paid according to the limitations of this chapter. F. The provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; (4) Home visits unless specifically authorized by federal law or regulation; (5) More than one visit to complete an EPSDT screen; and (6) Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. G. The Program may not make direct payment to participants. H. The Program may not make a separate direct payment to any person employed by or under contract to any freestanding clinic for services provided in a freestanding clinic. I. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .11 Recovery and Reimbursement. *COMAR 10.09.08.11* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .12 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.08.12* Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. #### Regulation .13 Appeal Procedures. *COMAR 10.09.08.13* Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09. #### Regulation .14 Interpretive Regulation. *COMAR 10.09.08.14* State regulations shall be interpreted in conformity with COMAR 10.09.36.10. ### Chapter 09 — Medical Laboratories **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: August 31, 1977 (4:18 Md. R. 1398) **Administrative History:** Regulation .01 amended effective August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .02 amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .03A repealed effective September 21, 1979 (6:19 Md. R. 1518) **Administrative History:** Regulation .03E amended effective December 15, 1978 (5:25 Md. R. 1854); August 22, 1988 (15:17 Md. R. 2049) **Administrative History:** Regulation .03E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) **Administrative History:** Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572) **Administrative History:** Regulation .03J adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .04A amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .04A amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .04C adopted effective July 11, 1988 (15:14 Md. R. 1654) **Administrative History:** Regulation .05 amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .05A and D amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .05B repealed effective August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .07 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .07B amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .07D amended effective December 15, 1978 (5:25 Md. R. 1854); February 15, 1982 (9:3 Md. R. 221) **Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1812) **Administrative History:** Regulation .07E amended effective December 6, 1982 (9:24 Md. R. 2390); November 21, 1983 (10:23 Md. R. 2063); May 27, 1984 (11:10 Md. R. 863); March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542); June 2, 1986 (13:11 Md. R. 1273); December 1, 1986 (13:22 Md. R. 2398) **Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); adopted permanently effective October 6, 1986 (13:20 Md. R. 2210) **Administrative History:** Regulation .07E amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987 **Administrative History:** Regulation .07E repealed and new Regulation .07E adopted effective February 9, 1987 (14:3 Md. R. 273); amended October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903) **Administrative History:** Regulation .07E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611) **Administrative History:** Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .07H amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended at 6:12 Md. R. 1045; adopted permanently effective June 1, 1979 (6:11 Md. R. 979) **Administrative History:** Regulation .07K amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .07K amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .07L adopted effective December 15, 1978 (5:25 Md. R. 1854) **Administrative History:** Regulation .07M adopted effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .09A, D amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Chapter revised as an emergency provision effective July 21, 1995 (22:16 Md. R. 1218); adopted permanently effective November 20, 1995 (22:23 Md. R. 1801) **Administrative History:** Regulation .01B amended effective September 18, 2000 (27:18 Md. R. 1665); April 29, 2002 (29:8 Md. R. 700); July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .03A amended effective April 29, 2002 (29:8 Md. R. 700); July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .03B amended effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .04 amended effective September 18, 2000 (27:18 Md. R. 1665) **Administrative History:** Regulation .04A amended effective April 29, 2002 (29:8 Md. R. 700); January 1, 2018 (44:26 Md. R. 1214); July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .05 amended effective September 18, 2000 (27:18 Md. R. 1665); October 10, 2016 (43:20 Md. R. 1109); January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .05A amended effective April 29, 2002 (29:8 Md. R. 700) **Administrative History:** Regulation .05B amended effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .06 adopted effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .07B amended effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .07B, D amended effective April 29, 2002 (29:8 Md. R. 700) **Administrative History:** Regulation .07C, D amended effective September 18, 2000 (27:18 Md. R. 1665) **Administrative History:** Regulation .07C, H amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07D amended effective December 12, 2011 (38:25 Md. R. 1581); February 27, 2017 (44:4 Md. R. 252) **Administrative History:** Regulation .07D, E amended effective June 14, 2021 (48:12 Md. R. 472) **Administrative History:** Regulation .07D, M amended effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430) **Administrative History:** Regulation .07L-P adopted effective September 18, 2000 (27:18 Md. R. 1665) **Administrative History:** Regulation .07L amended effective July 31, 2017 (44:15 Md. R. 759) #### Regulation .01 Definitions. *COMAR 10.09.09.01* A. In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.36.01 are applicable to this chapter. B. Terms Defined. (1) “Authorized practitioner” means a physician, osteopath, dentist, podiatrist, nurse midwife, nurse anesthetist, nurse practitioner, or physician assistant employed by a physician or clinic. (2) Freestanding Clinic. (a) “Freestanding clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. (b) “Freestanding clinic” does not include a clinic or clinic site located in a participant’s home. (3) “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and which is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. (4) “Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease. (5) “Order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed. (6) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (7) “Preauthorization” means the approval required from the Department or its designee before services can be rendered. (8) “Reference laboratory” means a medical laboratory, which is enrolled with the Program as either a provider or a renderer, to which a medical laboratory provider refers specimens from Medical Assistance participants for analysis. (9) “Referring laboratory” means a medical laboratory provider that refers specimens from Medical Assistance participants for analysis. (10) “Special handling” means a circumstance in which specimen collection and pickup are accomplished as independent procedures to be responsive to the medical needs of the participant or to preserve viability or condition of the specimen. (11) “Standing order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services to be supplied over a specific time period, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed. #### Regulation .02 License Requirements. *COMAR 10.09.09.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. Medical laboratories are required to ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed. C. Medical laboratories located in Maryland shall be in compliance with COMAR 10.10.01. D. Out-of-State Laboratories. (1) Laboratories with representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed, and that requirements of applicable sections of COMAR 10.10.01 are met. (2) Laboratories without representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed. #### Regulation .03 Conditions for Participation. *COMAR 10.09.09.03* A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03, except that a signature on the services order specified in COMAR 10.09.36.03A(19) is not required. B. Specific requirements for participation in the Program as a medical laboratory include all of the following: (1) Be in compliance with all applicable license, certification, environmental, legal, and professional requirements to perform the clinical laboratory services offered; (2) Maintain records adequate to substantiate the ordering, performance, and reporting of clinical laboratory services performed or referred; (3) Agree to seek reimbursement from the Program only for services set forth in Regulation .04 of this chapter when provided to eligible participants; (4) Agree to refrain from billing participants for noncovered services set forth in Regulation .05 of this chapter; and (5) Agree to abide by all provisions set forth in Regulation .07 of this chapter when seeking reimbursement from the Program. #### Regulation .04 Covered Services. *COMAR 10.09.09.04* The Program covers the following services: A. Medically necessary laboratory services, when the services are: (1) Rendered to participants in a physician's office, hospital, freestanding clinic, or medical laboratory; (2) Provided according to the laws and regulations of the state and locality in which they are rendered; (3) Rendered pursuant to a properly completed order or standing order; (4) Adequately documented in the provider’s files; (5) Clinical and diagnostic services for which certification by the Centers for Medicare and Medicaid Services (CMS) under CLIA exists, if required; and (6) Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service; B. Transportation of specimens by medical laboratories when special handling is required by medical necessity when documentation is supplied to the provider by the authorized ordering practitioner; and C. Collection of specimens by venipuncture, capillary puncture, or arterial puncture. #### Regulation .05 Limitations. *COMAR 10.09.09.05* The following are not covered: A. Services for which the medical laboratory provider cannot supply a properly completed order or standing order identifying the individual practitioner who ordered the laboratory services; B. Services not adequately documented in the participant’s medical records; C. Services denied by Medicare as not medically necessary; D. Clinical laboratory services, for which certification by HCFA under CLIA is required, when these services are performed by laboratories that are not certified to perform those services; E. Procedures that the provider knows or should know are investigational or experimental in nature; F. Services included by the Program as part of the charge made by an inpatient facility, hospital outpatient department, freestanding clinic, or other Program-recognized entity; G. Medical laboratory services related to autopsies; H. Medical laboratory services for which there was insufficient quantity of specimen, improper specimen handling, or other circumstances that would render the results unreliable; and I. Laboratory services ordered by an: (1) Individual who is not enrolled as a provider in the Program with an active status on the date of service; and (2) Entity, facility, or another provider that is not an individual. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.09.06* A. Preauthorization is required for any service identified as needing preauthorization in the current laboratory fee schedule, in accordance with Regulation .07D of this chapter. B. The provider shall submit the request for preauthorization according to the procedures established by, and in the form designated by, the Department. C. Preauthorization is issued when: (1) Program procedures are met; and (2) The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. D. Preauthorization is valid for services rendered or initiated within 90 days of the date issued. E. Preauthorization for Services Billed to Medicare. (1) If Medicare covers and approves a service for which preauthorization by the Program is normally required, the Program shall waive preauthorization requirements for that service. (2) If Medicare rejects the entire claim or any part of a claim for a service that normally requires preauthorization, and the claim is referred to the Program for payment, the Program shall pay only for the Medicare-rejected covered services if authorization for those services was obtained prior to the date of service. #### Regulation .07 Payment Procedures. *COMAR 10.09.09.07* A. General policies for payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. B. Medical laboratory providers shall identify the individual who ordered the laboratory services by recording the individual practitioners National Provider Identifier (NPI) number on the claim. C. Unless the service is free to individuals not covered by Medicaid, the provider shall charge the Program the lesser of: (1) The providers customary charge to the general public; or (2) The providers customary charge to other third-party payers. D. Providers are reimbursed according to the 2022 Medical Laboratory Fee Schedule (Effective March 2022). All the provisions of this document are incorporated by reference. E. The Department will pay for covered services the amount that is the lower of the following: (1) Provider's charge according to §C of this regulation; or (2) Departments maximum rates according to §D of this regulation. F. Payments on Medicare claims are authorized if: (1) The provider accepts Medicare assignments; (2) Initial billing is made directly to Medicare according to Medicare guidelines; and (3) Medicare has determined that services were medically justified. G. Supplemental payment on Medicare claims is made subject to the following provisions: (1) Deductible insurance will be paid in full; (2) Beginning with August 1, 2010 dates of service, coinsurance shall be paid: (a) In full for the following: (i) Mental health services; (ii) CPT codes that are priced by report; (iii) Claims for anesthesia services; (iv) Claims from a federally qualified health center; and (v) HCPCS codes beginning with A through W; and (b) For all other claims, at the lesser of: (i) 100 percent of the coinsurance amount; or (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare, but covered by the Program, will be paid according to §E of this regulation. H. The provider may not bill the Department for: (1) Completion of forms and reports; (2) Broken or missed appointments; or (3) Services listed in Regulation .05 of this chapter. I. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. J. When seeking reimbursement for medical laboratory services which are subjected to panel billing regulations or are part of a panel, the medical laboratory provider shall bill the Department the panel rate or the sum of the charges of the individual tests, whichever is less. K. A referring laboratory provider may bill the Program for laboratory services performed by a reference laboratory when the: (1) Reference laboratory is: (a) Enrolled with the Program as either a medical laboratory provider or a renderer; and (b) CLIA certified for the procedures performed; (2) Procedures which were referred, and the identity of the reference laboratory, are identified on the invoice; and (3) Referring laboratory charges not more than the amount it actually paid the reference laboratory. L. Standing orders shall: (1) Conform to the specifications for orders found in Regulations .01 and .04 of this chapter; (2) Include: (a) A date which shall become the starting date of the order unless another starting date is specified on the order; and (b) Specific instructions outlining the schedule of services to be provided pursuant to the order; and (3) Be effective for a maximum of 90 days or, for dialysis patients, be effective for a maximum of 1 year. M. All indices, calculated values, or other results that are not directly determined, are considered part of the parent procedures and are not separately billable to either the Program or the participant. N. Only those panels or profiles that have a composition specified by CPT or the Program are reimbursable as panels or profiles by the Program. Reimbursement for these recognized panels or profiles is not authorized unless each and every component of the panel or profile is performed. O. Two or more of the following chemistry tests shall be reimbursed at a rate that is the lesser of the provider's lowest charge to the general public or third-party payers, or the Program's maximum reimbursement for these chemistry tests when performed as panels: (1) Albumin, serum; (2) Bilirubin, direct; (3) Bilirubin, total; (4) Calcium, total; (5) Carbon dioxide (bicarbonate); (6) Chloride, blood; (7) Cholesterol, serum, total; (8) Creatine kinase (CK), (CPK), total; (9) Creatinine, blood; (10) Glucose, quantitative; (11) Glutamyltransferase, gamma (GGT); (12) Lactate dehydrogenase (LD), (LDH); (13) Phosphatase, alkaline; (14) Phosphorus, inorganic; (15) Potassium, serum; (16) Protein, total, except refractometry; (17) Protein, total, refractometric; (18) Sodium, serum; (19) Transferase, aspartate amino (AST) (SGOT); (20) Transferase, alanine amino (ALT) (SGPT); (21) Triglycerides; (22) Urea nitrogen, quantitative (BUN); and (23) Uric acid, blood. P. All of the tests listed in §O of this regulation that are ordered on or performed on the same specimen shall be billed as if performed simultaneously. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.09.08* General policies for recovery and reimbursement that are applicable to all providers are set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.09.09* General policies governing cause for suspension or removal and imposing sanctions that are applicable to all providers are set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.09.10* General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.09.11* General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10. ### Chapter 10 — Nursing Facility Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, 19-14B-01, and 19-310.1, Annotated Code of Maryland **Administrative History:** Effective date: July 9, 1975 (2:15 Md. R. 1070) **Administrative History:** Regulation .03E amended effective January 30, 1976 (3:4 Md. R. 216) **Administrative History:** Regulation .03H amended effective December 31, 1975 (3:4 Md. R. 216) **Administrative History:** Regulation .03Q adopted as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); adopted permanently effective October 21, 1977 (4:22 Md. R. 1671) **Administrative History:** Regulation .03X amended effective September 29, 1976 (3:20 Md. R. 1143) **Administrative History:** Regulation .05 amended effective August 17, 1977 (4:17 Md. R. 1298) **Administrative History:** Regulation .06 amended as an emergency provision effective April 1, 1977 (4:8 Md. R. 631); emergency status extended at 4:17 Md. R. 1291) **Administrative History:** Regulation .06 amended effective August 17, 1977 (4:17 Md. R. 1298) **Administrative History:** Regulation .06B amended effective January 30, 1976 (3:4 Md. R. 216) **Administrative History:** Regulation .06C adopted as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); adopted permanently effective October 21, 1977 (4:22 Md. R. 1671) **Administrative History:** Regulation .07 amended effective August 17, 1977 (4:17 Md. R. 1298) **Administrative History:** Regulation .09 amended effective August 17, 1977 (4:17 Md. R. 1298) **Administrative History:** Regulation .09A amended effective September 29, 1976 (3:20 Md. R. 1143) **Administrative History:** Regulation .09B amended as an emergency provision effective April 1, 1977 (4:8 Md. R. 631); emergency status extended at 4:17 Md. R. 1291 **Administrative History:** Regulation .09B, D amended effective January 30, 1976 (3:4 Md. R. 216) **Administrative History:** Regulation .09A amended as an emergency provision effective July 1, 1977 (4:15 Md. R. 1143); amended permanently effective October 21, 1977 (4:22 Md. R. 1671) **Administrative History:** Regulation .09A amended as an emergency provision effective June 13, 1978 (5:13 Md. R. 1039) **Administrative History:** Regulations .03 and .09 amended as an emergency provision effective January 1, 1978 (5:1 Md. R. 15) **Administrative History:** Regulations .03, .06, .08, and .09 amended as an emergency provision effective March 15, 1978 (5:9 Md. R. 681) **Administrative History:** Chapter revised effective July 1, 1978 (5:13 Md. R. 1051) **Administrative History:** Regulations .01U, HH, II, LL; .02; .03; .04G; .07; .09; .11E amended effective December 14, 1979 (6:25 Md. R. 1980) **Administrative History:** Regulation .01M-1 and M-2 adopted effective July 1, 1980 (7:13 Md. R. 1278) **Administrative History:** Regulations .01O, .03D, and .11E amended effective January 1, 1980 (6:26 Md. R. 2074) **Administrative History:** Regulations .01JJ, KK; .07-1; .08A-1 adopted effective December 14, 1979 (6:25 Md. R. 1980) **Administrative History:** Regulation .01P repealed effective January 1, 1980 (6:26 Md. R. 2074) **Administrative History:** Regulation .05A repealed effective December 14, 1979 (6:25 Md. R. 1980) **Administrative History:** Regulation .07B amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1132); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .07-2 adopted effective July 1, 1980 (7:13 Md. R. 1278) **Administrative History:** Regulation .08E amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .11 amended effective December 20, 1982 (9:25 Md. R. 2482) **Administrative History:** Regulation .16A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .18 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Chapter revised effective January 1, 1983 (9:25 Md. R. 2480) **Administrative History:** Regulation .01B amended effective June 6, 1983 (10:11 Md. R. 975); August 10, 1987 (14:16 Md. R. 1773) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1627); adopted permanently effective December 1, 1986 (13:21 Md. R. 2320) **Administrative History:** Regulation .03 amended as an emergency provision effective February 18, 1983 (10:6 Md. R. 536) **Administrative History:** Regulation .03P amended, Q adopted effective June 6, 1983 (10:11 Md. R. 975) **Administrative History:** Regulation .03R adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .03S adopted effective July 28, 1986 (13:15 Md. R. 1734) **Administrative History:** Regulation .03T and U adopted effective August 10, 1987 (14:16 Md. R. 1773) **Administrative History:** Regulation .04G amended effective October 29, 1984 (11:21 Md. R. 1812) **Administrative History:** Regulation .05 amended effective June 1, 1988 (15:11 Md. R. 1331) **Administrative History:** Regulation .07B amended and .07H adopted as an emergency provision effective June 27, 1983 (10:14 Md. R. 1257); adopted permanently effective October 24, 1983 (10:21 Md. R. 1901) **Administrative History:** Regulation .07B amended effective June 6, 1983 (10:11 Md. R. 975); August 10, 1987 (14:16 Md. R. 1773) **Administrative History:** Regulation .07B and E amended effective July 1, 1984 (11:12 Md. R. 1063) **Administrative History:** Regulation .07B, C, F, G amended and .07C-1 adopted as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); adopted permanently effective December 1, 1986 (13:22 Md. R. 2398) **Administrative History:** Regulation .07C amended effective October 29, 1984 (11:21 Md. R. 1812) **Administrative History:** Regulation .07D amended effective July 18, 1983 (10:14 Md. R. 1262); July 1, 1987 (14:13 Md. R. 1473); June 1, 1988 (15:11 Md. R. 1331); July 1, 1988 (15:13 Md. R. 1553) **Administrative History:** Regulation .07D amended as an emergency provision effective January 26, 1988 (15:4 Md. R. 469); adopted permanently effective May 15, 1988 (15:8 Md. R. 1009) **Administrative History:** Regulation .07E amended effective January 27, 1986 (13:2 Md. R. 137); July 1, 1988 (15:13 Md. R. 1533); September 5, 1988 (15:18 Md. R. 2147) **Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1627); adopted permanently effective December 1, 1986 (13:21 Md. R. 2320) **Administrative History:** Regulation .07G amended effective December 29, 1986 (13:26 Md. R. 2807) **Administrative History:** Regulation .07H repealed effective August 10, 1987 (14:16 Md. R. 1773) **Administrative History:** Regulation .08 amended as an emergency provision effective July 1, 1985 (12:14 Md. R. 1427); emergency status expired November 4, 1985 **Administrative History:** Regulation .08 amended effective November 4, 1985 (12:22 Md. R. 2103) **Administrative History:** Regulation .09A amended effective September 5, 1988 (15:18 Md. R. 2147) **Administrative History:** Regulation .10E amended effective August 10, 1987 (14:16 Md. R. 1773) **Administrative History:** Regulation .10I amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .12D repealed effective August 10, 1987 (14:16 Md. R. 1773) **Administrative History:** Regulation .13E amended as an emergency provision effective January 1, 1983 (10:1 Md. R. 21); adopted permanently effective May 1, 1983 (10:7 Md. R. 634) **Administrative History:** Regulation .13F amended as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); adopted permanently effective December 1, 1986 (13:22 Md. R. 2398) **Administrative History:** Regulation .14K adopted as an emergency provision effective June 27, 1983 (10:14 Md. R. 1257); adopted permanently effective October 24, 1983 (10:21 Md. R. 1901) **Administrative History:** Regulation .14K repealed effective August 10, 1987 (14:16 Md. R. 1773) **Administrative History:** Regulation .17A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .19 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Chapter revised effective November 27, 1989 (16:23 Md. R. 2505) **Administrative History:** Regulations .01, .07—.12, .16, and .25 amended as an emergency provision effective January 14, 1992 (19:3 Md. R. 299); emergency status expired June 30, 1992 **Administrative History:** Regulations .01, .07—.13, .16, .17, .23, and .25 amended as an emergency provision effective July 1, 1992 (19:14 Md. R. 1272); amended permanently effective November 1, 1992 (19:21 Md. R. 1891) **Administrative History:** Regulations .01, .04, .08—.11, .16, .17, .20, .21, and .23 amended as an emergency provision effective July 1, 2005 (32:19 Md. R. 1584); emergency status expired August 31, 2005 **Administrative History:** Regulation .01B amended effective March 19, 1990 (17:5 Md. R. 638); December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .01B amended as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); amended permanently effective August 16, 2004 (31:16 Md. R. 1255) **Administrative History:** Regulation .01B amended effective May 9, 2005 (32:9 Md. R. 848); December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .01B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527) **Administrative History:** Regulation .01B amended effective January 24, 2011 (38:2 Md. R. 84); October 3, 2011 (38:20 Md. R. 1202); October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .02 amended effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .03 amended effective March 19, 1990 (17:5 Md. R. 638); December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .03V amended effective October 3, 2011 (38:20 Md. R. 1202) **Administrative History:** Regulation .03W adopted effective October 3, 2011 (38:20 Md. R. 1202) **Administrative History:** Regulations .04, .10L, .11F, O, and .25B amended as an emergency provision effective July 3, 1990 (17:16 Md. R. 1986); amended permanently effective November 1, 1990 (17:21 Md. R. 2529) **Administrative History:** Regulations .04, .05, .07—.11, .13, .16, and .25 amended and new Regulation .09-1 adopted as an emergency provision effective October 1, 1999 (26:23 Md. R. 1775); adopted permanently effective January 9, 2000 (26:27 Md. R. 2015) **Administrative History:** Regulation .04 amended effective August 15, 1994 (21:16 Md. R. 1383); December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .04D repealed effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .04E amended effective December 9, 2005 (32:24 Md. R. 1904); March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .04BB adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .04BB adopted effective September 22, 2008 (35:19 Md. R. 1716) **Administrative History:** Regulation .05 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .05 amended effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .05G amended effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .06 amended effective December 29, 1997 (24:26 Md. R. 1758); July 8, 2002 (29:13 Md. R. 990) **Administrative History:** Regulations .07—.11 amended as an emergency provision effective December 1, 2001 (29:1 Md. R. 17) **Administrative History:** Regulations .07—.11-1 and .26 amended as an emergency provision effective July 1, 1995 (22:15 Md. R. 1114); emergency status expired November 1, 1995; amended permanently effective November 6, 1995 (22:22 Md. R. 1658) **Administrative History:** Regulation .07 amended effective July 8, 2002 (29:13 Md. R. 990) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .07 amended effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .07 amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527) **Administrative History:** Regulation .07 amended effective November 28, 2011 (38:24 Md. R. 1502); March 18, 2013 (40:5 Md. R. 411); December 12, 2013 (40:24 Md. R. 2016); December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .07A amended effective June 25, 1990 (17:12 Md. R. 1494) **Administrative History:** Regulation .07A-2 adopted effective February 12, 2007 (34:3 Md. R. 297) **Administrative History:** Regulation .07A-2 amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 **Administrative History:** Regulation .07A-2, C amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .07A-2, C amended effective September 22, 2008 (35:19 Md. R. 1716) **Administrative History:** Regulation .07A-3 adopted effective September 22, 2008 (35:19 Md. R. 1716) **Administrative History:** Regulation .07A-3 amended effective April 6, 2009 (36:7 Md. R. 523) **Administrative History:** Regulation .07A-4 adopted effective April 6, 2009 (36:7 Md. R. 523) **Administrative History:** Regulation .07B amended effective February 12, 2007 (34:3 Md. R. 297) **Administrative History:** Regulation .07C amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .07C-1 amended effective April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .07C-2 and C-3 adopted effective April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .07C-4 adopted effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .07-1 adopted as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); adopted permanently effective August 16, 2004 (31:16 Md. R. 1255) **Administrative History:** Regulation .07-1F, I amended effective April 10, 2006 (33:7 Md. R. 668); August 27, 2007 (34:17 Md. R. 1508); September 22, 2008 (35:19 Md. R. 1716) **Administrative History:** Regulation .07-1I amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 5, 2009 (36:20 Md. R. 1527) **Administrative History:** Regulation .07-1I amended effective January 24, 2011 (38:2 Md. R. 84); October 3, 2011 (38:20 Md. R. 1202); February 18, 2013 (40:3 Md. R. 218); February 3, 2014 (41:2 Md. R. 91); December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulations .08—.11-1, .17, .20, and .21 amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1081); amended permanently effective November 4, 1996 (23:22 Md. R. 1496) **Administrative History:** Regulations .08—.11 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1149) (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulations .08—.11 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1181); amended permanently effective October 19, 1998 (25:21 Md. R. 1574) **Administrative History:** Regulations .08—.11, .13, and .16 amended as an emergency provision effective July 1, 1999 (26:16 Md. R. 1237 and 26:18 Md. R. 1369); emergency status expired September 30, 1999 **Administrative History:** Regulation .08 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .08 amended effective February 16, 2004 (31:3 Md. R. 207); September 22, 2008 (35:19 Md. R. 1716); March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .08B amended effective July 1, 1993 (20:12 Md. R. 996); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .08B, E amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 **Administrative History:** Regulation .08B, E amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .08B, E amended effective April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502); December 12, 2013 (40:24 Md. R. 2016) **Administrative History:** Regulation .08B, E, H amended effective September 22, 2008 (35:19 Md. R. 1716) **Administrative History:** Regulation .08E amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulations .08E, .09E, and .10L amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 95); emergency status extended at 21:9 Md. R. 744; emergency status expired June 5, 1994 **Administrative History:** Regulations .08E, .09E, and .10L amended as an emergency provision effective July 1, 1994 (21:16 Md. R. 1379); emergency status expired November 7, 1994 **Administrative History:** Regulation .08H adopted effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .08H repealed as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 **Administrative History:** Regulation .08H repealed as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .09B amended effective July 1, 1993 (20:12 Md. R. 996); October 20, 1997 (24:21 Md. R. 1449) **Administrative History:** Regulation .09E amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449) **Administrative History:** Regulation .09E amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .09E amended effective February 16, 2004 (31:3 Md. R. 207); December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .09E amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 **Administrative History:** Regulation .09E amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .09E amended effective April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502) **Administrative History:** Regulation .09E, F amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .09E, H amended effective September 22, 2008 35:19 Md. R. 1716) **Administrative History:** Regulation .09H adopted effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .09H repealed as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286 **Administrative History:** Regulation .09H repealed as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .10 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .10 amended effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .10C amended effective September 20, 2010 (37:19 Md. R. 1283) **Administrative History:** Regulation .10G amended effective December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .10G amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 **Administrative History:** Regulation .10G amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .10G amended effective September 22, 2008 35:19 Md. R. 1716); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502); March 18, 2013 (40:5 Md. R. 411); December 12, 2013 (40:24 Md. R. 2016) **Administrative History:** Regulation .10I amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .10L amended effective July 1, 1993 (20:12 Md. R. 996); June 6, 1994 (21:11 Md. R. 951); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449) **Administrative History:** Regulation .10N adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .10N adopted effective September 22, 2008 35:19 Md. R. 1716) **Administrative History:** Regulation .11 amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .11 amended effective July 8, 2002 (29:13 Md. R. 990) **Administrative History:** Regulation .11 amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003; March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .11 amended effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .11C amended effective July 1, 1993 (20:12 Md. R. 996) **Administrative History:** Regulation .11C amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 95); emergency status extended at 21:9 Md. R. 744 and 21:16 Md. R. 1379; emergency status expired August 14, 1994 **Administrative History:** Regulation .11C amended effective August 15, 1994 (21:16 Md. R. 1383); November 7, 1994 (21:22 Md. R. 1876); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .11C amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1345); emergency status extended at 35:3 Md. R. 286; emergency status expired June 24, 2008 **Administrative History:** Regulation .11C amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .11C amended effective September 22, 2008 35:19 Md. R. 1716); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); December 12, 2013 (40:24 Md. R. 2016) **Administrative History:** Regulation .11G amended effective August 15, 1994 (21:16 Md. R. 1383); October 20, 1997 (24:21 Md. R. 1449); December 9, 2005 (32:24 Md. R. 1904); April 5, 2010 (37:7 Md. R. 570); December 12, 2013 (40:24 Md. R. 2016) **Administrative History:** Regulation .11U adopted effective August 15, 1994 (21:16 Md. R. 1383) **Administrative History:** Regulation .11U adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892; emergency status expired September 3, 2008 **Administrative History:** Regulation .11U adopted effective September 22, 2008 35:19 Md. R. 1716) **Administrative History:** Regulation .11-1 adopted as an emergency provision effective January 6, 1994 (21:2 Md. R. 96); adopted permanently effective May 1, 1994 (21:7 Md. R. 530) **Administrative History:** Regulation .11-1 repealed as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .11-1 repealed effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulations .11-1—.11-6 adopted effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .11-1A amended effective November 28, 2011 (38:24 Md. R. 1502) **Administrative History:** Regulation .11-2E amended effective November 28, 2011 (38:24 Md. R. 1502) **Administrative History:** Regulation .12A amended effective February 12, 2007 (34:3 Md. R. 297) **Administrative History:** Regulation .13 amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .13E amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .13I amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .13I amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .13L adopted effective August 15, 1994 (21:16 Md. R. 1383) **Administrative History:** Regulation .13P adopted as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .13P adopted effective September 22, 2008 35:19 Md. R. 1716) **Administrative History:** Regulation .14 amended effective June 6, 1994 (21:11 Md. R. 951) **Administrative History:** Regulation .14C-1 adopted as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); adopted permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .14G amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .15 amended effective March 19, 1990 (17:5 Md. R. 638); October 3, 2011 (38:20 Md. R. 1202) **Administrative History:** Regulation .15A amended effective March 17, 2003 (30:5 Md. R. 366) **Administrative History:** Regulation .15B amended as an emergency provision effective May 1, 2004 (31:12 Md. R. 908); amended permanently effective August 16, 2004 (31:16 Md. R. 1255) **Administrative History:** Regulation .16 amended effective February 19, 1990 (17:3 Md. R. 297); December 29, 1997 (24:26 Md. R. 1758); July 8, 2002 (29:13 Md. R. 990); March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .16D amended effective April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulations .16E and G, and .17J amended and .17K adopted as an emergency provision effective April 4, 1991 (18:9 Md. R. 1004); adopted permanently effective July 22, 1991 (18:14 Md. R. 1609) **Administrative History:** Regulations .16E and G amended and .30 adopted as an emergency provision effective January 1, 1991 (18:2 Md. R. 146); emergency status expired April 8, 1991 (18:9 Md. R. 1005) **Administrative History:** Regulation .16E amended effective September 27, 2004 (31:19 Md. R. 1432); October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .16F amended effective March 17, 2003 (30:5 Md. R. 366) **Administrative History:** Regulation .16F amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .16F amended effective February 16, 2004 (31:3 Md. R. 207); December 9, 2005 (32:24 Md. R. 1904); April 6, 2009 (36:7 Md. R. 523); December 27, 2010 (37:26 Md. R. 1787); November 28, 2011 (38:24 Md. R. 1502) **Administrative History:** Regulation .16G amended effective June 3, 1996 (23:11 Md. R. 810) **Administrative History:** Regulation .17 amended effective July 8, 2002 (29:13 Md. R. 990); May 9, 2005 (32:9 Md. R. 848); December 9, 2005 (32:24 Md. R. 1904); March 18, 2013 (40:5 Md. R. 411); December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .17K amended and L—O adopted effective June 6, 1994 (21:11 Md. R. 951) **Administrative History:** Regulation .18A amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulations .20—.23 amended as an emergency provision effective January 6, 1994 (21:2 Md. R. 96); adopted permanently effective May 1, 1994 (21:7 Md. R. 531) **Administrative History:** Regulation .20 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1181); amended permanently effective October 19, 1998 (25:21 Md. R. 1574) **Administrative History:** Regulation .20 amended effective December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .21 amended effective December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .22 amended as an emergency provision effective April 1, 2008 (35:9 Md. R. 892); emergency status expired September 3, 2008 **Administrative History:** Regulation .22 amended effective September 22, 2008 35:19 Md. R. 1716) **Administrative History:** Regulation .23 amended effective December 9, 2005 (32:24 Md. R. 1904) **Administrative History:** Regulation .24A, B amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .24A, B amended effective February 16, 2004 (31:3 Md. R. 207); March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .25B amended effective August 15, 1994 (21:16 Md. R. 1383); February 16, 2004 (31:3 Md. R. 207); February 12, 2007 (34:3 Md. R. 297); March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .25C amended as an emergency provision effective July 1, 2003 (30:15 Md. R. 990); emergency status expired December 31, 2003 **Administrative History:** Regulation .27A amended effective June 6, 1994 (21:11 Md. R. 951) **Administrative History:** Regulation .27A-1 adopted as an emergency provision effective October 16, 1995 (22:22 Md. R. 1654); adopted permanently effective January 15, 1996 (23:1 Md. R. 25) **Administrative History:** Regulation .27C amended effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .28 amended effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .30 adopted effective May 9, 2005 (32:9 Md. R. 848) **Administrative History:** Chapter revised effective April 13, 2015 (42:7 Md. R. 567) **Administrative History:** Regulation .07-1I amended effective December 19, 2016 (43:25 Md. R. 1384); January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .07-2 amended effective February 29, 2016 (43:4 Md. R. 331) **Administrative History:** Regulation .07-2L, M adopted effective December 19, 2016 (43:25 Md. R. 1384) **Administrative History:** Regulation .07-2N adopted effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .10-1B amended effective February 29, 2016 (43:4 Md. R. 331); December 19, 2016 (43:25 Md. R. 1384) **Administrative History:** Regulation .11-2B amended effective December 19, 2016 (43:25 Md. R. 1384) **Administrative History:** Regulation .11-7C amended effective December 19, 2016 (43:25 Md. R. 1384) **Administrative History:** Regulation .11-8C amended effective December 19, 2016 (43:25 Md. R. 1384) **Administrative History:** Regulation .12-1A, B amended effective February 29, 2016 (43:4 Md. R. 331) **Administrative History:** Regulation .13O amended effective February 29, 2016 (43:4 Md. R. 331) **Administrative History:** Regulation .15-1 amended effective February 29, 2016 (43:4 Md. R. 331) **Administrative History:** Regulation .15-1D amended effective December 19, 2016 (43:25 Md. R. 1384) **Administrative History:** Regulation .16-1G amended effective February 29, 2016 (43:4 Md. R. 331) **Administrative History:** Regulation .16-1I adopted effective February 29, 2016 (43:4 Md. R. 331) **Administrative History:** Regulation .25C adopted effective December 19, 2016 (43:25 Md. R. 1384) **Administrative History:** Regulation .28B amended effective February 29, 2016 (43:4 Md. R. 331) **Administrative History:** Chapter revised effective July 2, 2018 (45:13 Md. R. 664) **Administrative History:** Regulation .01B amended effective June 14, 2021 (48:12 Md. R. 472) **Administrative History:** Regulation .07 amended effective August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .07G amended effective May 20, 2019 (46:10 Md. R. 486); December 30, 2019 (46:26 Md. R. 1164); November 14, 2022 (49:23 Md. R. 995); September 16, 2024 (51:18 Md. R. 808), March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .07H, I adopted effective November 14, 2022 (49:23 Md. R. 995) **Administrative History:** Regulation .08H amended effective May 20, 2019 (46:10 Md. R. 486); December 30, 2019 (46:26 Md. R. 1164); June 14, 2021 (48:12 Md. R. 472); November 14, 2022 (49:23 Md. R. 995); August 7, 2023 (50:15 Md. R. 681); September 16, 2024 (51:18 Md. R. 808); March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .13A amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .15 amended effective June 14, 2021 (48:12 Md. R. 472) **Administrative History:** Regulation .19 amended effective June 14, 2021 (48:12 Md. R. 472 **Administrative History:** Regulation .19A amended effective November 14, 2022 (49:23 Md. R. 995) **Administrative History:** Regulation .21P adopted effective November 14, 2022 (49:23 Md. R. 995) **Administrative History:** Regulation .22B amended effective November 14, 2022 (49:23 Md. R. 995) **Administrative History:** Regulation .30 amended effective December 30, 2019 (46:26 Md. R. 1164) #### Regulation .01 Definitions. *COMAR 10.09.10.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accrual basis” means recording revenue in the period when earned, regardless of when collected, and recording expenses in the period when incurred, regardless of when paid. (2) “Administrative day” means a day of care rendered to a recipient who no longer requires the level of care being provided. (3) “Allowable cost” means costs that are includable in the per diem rate and that represent the provider's actual cost as verified by the Department or the Department's designee. (4) “Appropriate facility” means a facility located within a 25-mile radius of the location of the facility currently rendering care to the recipient or a more distant facility if acceptable to the recipient, which facility is licensed and certified to render the recipient's required level of care. (5) “Bad debts” means amounts considered to be uncollectible from accounts and notes receivable that were created or acquired in providing services. “Accounts receivable” and “notes receivable” are designations for claims arising from rendering services which, when made or entered, were considered collectible in money in the relatively near future. (6) “Case mix index (CMI)” means a numeric score that identifies the average relative nursing resource needs for the residents classified under the Resource Utilization Group (RUG) based on the assessed nursing needs of the resident, whose values are set forth as CMI Set F01, located at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/NursingHomeQualityInits/NHQIMDS30TechnicalInformation.html. (7) “Centers for Medicare and Medicaid Services (CMS)” means the federal agency that is located in the U.S. Department of Health and Human Services that administers the Medicare and Medicaid programs. (8) “Change of ownership” means: (a) One of the following occurs: (i) The merger of the provider into the acquiring entity and the acquiring entity's tax identification number remains; (ii) The assignment, transfer, disposition, lease, or sale of all or substantially all of a provider’s assets to another entity; (iii) The consolidation of two or more providers, resulting in the creation of a new entity; or (iv) The merger of the provider into another entity, or the consolidation of two or more entities, resulting in the creation of a new entity; (b) A provider’s Medical Assistance participating provider number dissolves or will no longer be utilized for purposes of billing the Program for covered services; and (c) A new Medical Assistance participating provider number or tax identification number is used instead. (9) “Cost center” means one of the groups into which similar categories of costs are assigned for reimbursement rate determination: Administrative and Routine, Other Patient Care, Nursing Service, and Capital. (10) “Cost report period case mix index” means the simple average of the day weighted facility case mix indices for residents of all payer sources from the final quarterly resident rosters for a nursing facility, carried to four decimal places, for the quarterly resident roster periods that most closely match a cost reporting period. (11) “Credit balance” means: (a) A third party payment, which is in addition to the Medicaid payment; (b) The Medicaid payment in excess of the amount due the provider; or (c) A duplicate payment. (12) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (13) “Facility” means a facility licensed under COMAR 10.07.02 and certified as meeting the requirements of Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., for participation as a nursing facility. (14) “Facility average Medicaid case mix index” means the day-weighted average case mix index for all identified Medicaid days from each nursing facility's final resident roster for each resident roster quarter calculated as the sum of the number of days each assessment associated with a Medicaid payer source is active times the assessment CMI divided by the sum of all Medicaid payer source days. (15) “Final report” means the third party liability audit report issued to a provider stating the total amount due to the Department as a result of the completed audit. (16) “Fiscal year” means a 12-month reporting period covering the same period as the facility's tax return, unless waived by the Department according to standards found in Medicare Provider Reimbursement Manual, HCFA Publication 15-1. (17) “Indemnity bond” means a bond posted by the provider to ensure that the provider is able to fulfill any financial obligations to the Department upon sale of the facility. (18) “Interim Working Capital Fund” means funding made available to providers on a temporary basis that shall be repaid to the Department. (19) “Market basket index” means inflation indices from the latest Skilled Nursing Home without Capital Market Basket Index, published 2 months before the period in which rates are being calculated and which is available from CMS at www.cms.gov, or a comparable index available from, and used by, CMS, if this index ceases to be published by Global Insight, Inc. or its successor. (20) “Maryland Health Care Commission” means the agency established by Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. (21) “Medicaid” means Medical Assistance provided under the State Plan approved under Title XIX of the Social Security Act. (22) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (23) “Medicare upper payment limit” means that aggregate payments to nursing facilities may not exceed the limits established for such payment in 42 CFR §447.272. (24) “Minimum Data Set (MDS)” means the MDS required by 42 CFR §483.20 and set forth in the Resident Assessment Instrument published by CMS, and available at www.cms.gov, incorporated herein by reference, as amended and supplemented, a core set of screening, clinical, and functional status elements, including common definitions and coding categories that forms the foundation of the assessment required for all residents in Medicare-certified or Medicaid-certified nursing facilities. (25) “New facility” means: (a) A facility that has not been a provider during the previous 12-month period or, for rates effective January 1, 2015 and after, does not have a cost report in the price database as set forth in Regulation .09B(1) of this chapter; and (b) A facility not defined as a replacement facility. (26) “Noncompliant” means: (a) A provider fails to submit to the Department the required quarterly report of credit balances; (b) A provider fails to submit a quarterly report which provides sufficient data relating to the credit balances it maintained during that quarter; or (c) A random audit by the Department reveals errors or omissions in a provider's credit balance report. (27) Nursing Facility (NF). (a) “Nursing facility” means an institution which is primarily engaged in providing to residents: (i) Skilled nursing care and related services for residents who require medical or nursing care; (ii) Rehabilitation services for the rehabilitation of injured, disabled, or sick persons; or (iii) On a regular basis, health-related care and services to individuals who, because of their mental or physical condition, require care and services (above the level of room and board) which can be made available to them only through institutional facilities. (b) “Nursing facility” means an institution which is licensed by the Department under COMAR 10.07.02. (c) “Nursing facility” does not include an institution which is primarily for the care and treatment of mental diseases, an intellectually disability or a developmental disability. (28) “Nursing facility services” means services provided to individuals who do not require hospital care, but who, because of their mental or physical condition, require skilled nursing care and related services, rehabilitation services, or, on a regular basis, health-related care and services (above the level of room and board) which can be made available to them only through institutional facilities. (29) “Owner” means a party or entity having any ownership interest in the facility. (30) “Patient day” means care of one patient for 1 day of service. The day of admission is counted as 1 day of care, but the day of discharge is not counted. If a patient is discharged on his day of admission, 1 patient day will be counted. (31) “Payroll-Based Journal” means a system for facilities to submit staffing information to meet the requirements of §6106 of the Affordable Care Act (ACA) that requires facilities to electronically submit direct care staffing information (including agency and contract staff) based on payroll and other auditable data. (32) “Personal needs fund” means that portion of the recipient's resource retained by the recipient for his personal use. (33) “Predischarge plan” means: (a) A written document describing who has operational responsibility for discharge planning; (b) The manner in and methods by which that person will function; (c) The time period in which each recipient's need for discharge planning will be determined; (d) The maximum time period after which a reevaluation of each recipient's discharge plan will be made; (e) The local resources available to the provider, the individual, and the attending physician to assist in developing and implementing individual discharge plans; and (f) Provisions for periodic review and reevaluation of the provider's discharge planning program. (34) “Program” means the Medical Assistance Program. (35) “Prospective rate” means a facility-specific quarterly per diem rate based on the RUG classification system, and calculated as the sum of: (a) Administrative and Routine rate as calculated in accordance with Regulation .09 of this chapter; (b) Other Patient Care Rate as calculated in accordance with Regulation .10 of this chapter; (c) Capital Rate as calculated in accordance with Regulation .11 of this chapter; and (d) Nursing Rate as calculated in accordance with Regulation .12 of this chapter. (36) “Provider” means a facility which has in effect a provider agreement with the Department. (37) “Provider agreement” means the contract between the Department and the provider covering the obligations of the parties under the Medical Assistance Program. (38) “Purchaser” means an entity that participates in a change of ownership with a provider by: (a) Having a provider merge into the entity; (b) Accepting the assignment, transfer, disposition, or sale of all or substantially all of a provider’s assets; or (c) Being a new entity that results from the consolidation of the provider with a third party. (39) “Quality measure” means a specific performance criterion, as described in Regulation .15 of this chapter, used to assess a facility’s performance level. (40) “Random sample” means the selection for audit by the Department of representative share of the providers complying with the requirement of submitting a quarterly report of credit balances to the Department. (41) “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. (42) “Recreational services” means those organized activities provided for the enjoyment of the patients that are designed to promote their physical, social, and mental well-being. (43) “Reimbursement class” means the group of providers for which a separate per diem rate will be prepared in the Administrative and Routine, Other Patient Care, and Nursing Service cost centers based on geographic region as set forth in Regulation .30 of this chapter. (44) “Relative of the owner” means the owner's husband, wife, natural parent, natural child, sibling, adopted child, adoptive parent, stepparent, stepchild, stepbrother, stepsister, father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, sister-in-law, grandparent, or grandchild. (45) “Replacement facility” means: (a) A newly constructed nursing facility that replaces an existing licensed and certified facility; or (b) A facility that was closed for significant renovation that reopens and is approved by the Department as a replacement facility. (46) “Resident roster” means a list of all residents in a nursing facility for a calendar quarter based on MDS assessments and tracking forms, accurately and successfully transmitted by the nursing facility into the CMS-approved submission system, used for the calculated day-weighted case mix indices for Medicaid, Medicare, and other payment sources. (47) “Resource” means that portion of a recipient's income available toward the cost of medical and remedial care as determined by the Department or its designee. (48) “Resource Utilization Group (RUG)” means the version IV (RUG-IV), 48-Group classification system, that has been developed by CMS for grouping nursing facility residents according to the residents’ functional status and anticipated uses of services and resources as identified from data supplied by the MDS. (49) “Secretary” means the Secretary of Health. (50) “Special focus facility” means a facility identified by the Centers for Medicare and Medicaid Services as having: (a) More problems than other nursing homes; (b) More serious problems than other nursing homes; and (c) A pattern of serious problems that has persisted over a long period of time. (51) “Specialized rehabilitative therapy services” means those services furnished by a provider as an integral part of a patient's care plan ordered by a physician and provided in conjunction with continuous nursing care for the purpose of the restoration of normal form and function after injury or illness. The services shall be performed by a licensed physical therapist, licensed physical therapy assistant, or registered occupational therapist. (52) “Standby letter of credit” means a written instrument prepared by a provider's bank authorizing the Department to draw on the bank, upon sale of the facility. (53) “Statewide average case mix index” means the simple average of all of the cost report period case mix indices for the rate year. (54) “Statewide average Medicaid case mix index” means the Medicaid day weighted average of all nursing facilities’ case mix indices for the Medicaid days identified on the final resident rosters for each resident roster quarter. (55) “Substandard quality of care” means a finding of substandard care in accordance with 42 CFR §488.301. (56) “Third party” means any individual entity or program that is or may be liable to pay all or part of the medical cost of any medical assistance furnished to a recipient under the Medical Assistance Program, including private health insurance, employment related health insurance, medical support from absent parents, automobile insurance, court judgments or settlements from a liability insurer, state workers' compensation, first party probate-estate recoveries, or any federal programs. (57) “Third party liability audit” means a financial review of Medical Assistance payments to a provider to ascertain the legal liability of third parties to pay for care and services available under the Medical Assistance Program. (58) “Third party liability review” means a financial review of the credit balances of a nursing facility to ascertain the legal liability of third parties to pay for care and services available under the Medical Assistance Program. (59) “Uniform cost report” means the cost report format which each facility is required to use in the submission of its fiscal year cost and utilization data, including supplemental schedules and other balance sheet and administrative data. #### Regulation .02 License Requirements. *COMAR 10.09.10.02* In order to participate in the Program, a provider shall be licensed by the Department, pursuant to Health-General Article, §19-301 et seq., Annotated Code of Maryland, and COMAR 10.07.02, and shall obtain other licenses, as may be required by applicable State and local laws. #### Regulation .03 Conditions for Participation. *COMAR 10.09.10.03* To participate in the Program, the provider shall: A. Be certified by the Department at its total licensed nursing facility bed capacity as meeting the requirements of Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., for participation as a nursing facility; B. Be in compliance with preadmission screening and resident review requirements as described by 42 CFR Part 483, Subpart C (1996); C. Be in compliance with the requirements of COMAR 10.09.36; D. Be approved for participation by the Department; E. Have a provider agreement in effect; F. Employ an organized medical staff or a medical director who is a licensed physician; G. Provide, according to the needs of the recipient, those services listed in Regulation .04 of this chapter; H. Accept payment by the Department as payment in full for covered services rendered and make no additional charge to any person for covered services except as provided for in Regulation .28 of this chapter; I. Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee; J. Provide services without regard to race, color, age, sex, national origin, marital status, physical or mental handicap; K. Verify the recipient's eligibility; L. Place no restriction on a recipient's right to select providers of his choice; M. Have in effect a predischarge plan; N. Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized in accordance with Regulation .06 of this chapter, the provider may not seek payment for that service from the recipient; O. Perform utilization control functions for all recipients designated eligible for nursing facility services as described by 42 CFR §§346.370, 456.360, 456.371, 456.380, and 456.381 (1996), and as required by the Utilization Control Plan for Selected Institutional Services Reimbursed by the Maryland Medical Assistance Program; P. Notify the Department or its designee of patient activity or circumstance that affects placement, eligibility, or reimbursement on such form and at such time as specified by the Department; Q. Before discharging any Medical Assistance recipient certified as requiring nursing facility services, place in the recipient's permanent medical record the following information on a consent form designated by the Department, a copy of which shall be submitted to the Department and to the Office on Aging: (1) A certification that the recipient or guardian has: (a) Been informed of the recipient's right to remain in the discharging facility and have the cost of care paid by the Medical Assistance Program; (b) Been informed that the Medical Assistance Program will not pay for room and board in a setting outside of a nursing facility and that the Program may pay for the cost of medical services received outside of a nursing facility subject to medical and financial eligibility determinations and covered services limitations; (c) Been informed of the recipient's right as a patient, as stated in the Health-General Article, §19-345, Annotated Code of Maryland; (d) Been informed of the services provided by and the location of the alternative placement; (e) Voluntarily given informed consent to the transfer; (2) If the recipient or guardian is unable or unwilling to sign the consent form, submit to the Department a written explanation of the reason written consent was not obtained, a copy of which shall be placed in the recipient's medical record; R. Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient; S. Include in all contracts with a cost or value over a 12-month period of $10,000 or more, with any subcontractor, a clause allowing the Department or its agent access to the subcontractor's books, documents, and records which are necessary to verify the nature and extent of costs of the services furnished under the contract in accordance with the principles established under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., and contained in the Medicare Provider Reimbursement Manual, HCFA Publication 15-1; T. Meet the requirements in the Certificate of Need application approved by the Maryland Health Resources Planning Commission; U. Notify the Medical Assistance Program, in writing, of the contemplated sale of the facility or a controlling interest not less than 30 days before the date of the change of ownership; V. Assure that an individual who is eligible for Medical Assistance at the time of application for admission to a nursing home, or would become eligible within 6 months following admission, has a long-term care assessment made available before admission, at no charge to the individual, pursuant to COMAR 10.09.30. The evaluation is advisory only and may not restrict the right of an individual to select nursing home services; and W. Not less than 30 days before the date of any change of ownership, except when the Program agrees to a shorter period, provide the Department the notification and indemnity bond, letter of credit, or certificate of assurance required by Regulation .25D(1)—(3) of this chapter. #### Regulation .04 Covered Services. *COMAR 10.09.10.04* The Program covers routine care and the following supplies, equipment, and services when appropriate to meet the needs of the recipient: A. Those described in the Maryland Department of Health regulations entitled “Requirements for Long Term Care Facilities”, 42 CFR Part 483, Subpart B (1996), subject to limitations in Regulation .05 of this chapter. B. Over-the-counter drugs. C. Bed reservations for recipients who are on a leave of absence to visit with friends or relatives or to participate in State-approved therapeutic or rehabilitative programs for a maximum of 18 days in any calendar year and without any limitation on the number of days per visit. D. Repealed. E. Administrative days approved by the Department or its designee according to the conditions set forth in Regulation .26D of this chapter. F. Specialized rehabilitative therapy services which meet the conditions listed below: (1) Physical Therapy. Physical therapy services for Medical Assistance Program purposes are those services furnished to a recipient which meet all of the following conditions: (a) The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified physical therapist; (b) The services are of such a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, or skills of a qualified physical therapist; (c) The services are performed by or under the supervision of a qualified physical therapist; (d) The services are provided with the expectation, based on the assessment made by the physician of the recipient's restorative potential after any needed consultation with the qualified physical therapist, that the recipient will improve significantly in a reasonable, and generally predictable, period of time; (e) The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and (f) The services are reasonable and necessary to the treatment of the recipient's condition. (2) Occupational Therapy. Occupational therapy services for Medical Assistance Program purposes are those which meet the following conditions: (a) The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified occupational therapist; (b) The services are on a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, and skills of a qualified occupational therapist; (c) The services are performed by a qualified occupational therapist; (d) The services are for the purposes of improving or restoring functions which have been impaired by illness or injury or, if function has been permanently lost or reduced by illness or injury, to improve the individual's ability to perform those tasks required for independent functioning; (e) The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and (f) The services are reasonable and necessary to the treatment of the recipient's condition. (3) Speech Therapy. Speech therapy services for Medical Assistance Program purposes are those services furnished to a recipient which meet all of the following conditions: (a) The services are directly and specifically related to a plan of care designed by the physician after any needed consultation with the qualified speech and language pathologist; (b) The services are of such a level of complexity and sophistication or the condition of the recipient needs the judgment, knowledge, and skills of a qualified speech and language pathologist; (c) The services are performed by or under the supervision of a qualified speech and language pathologist; (d) The services are provided with the expectation, based on the assessment made by the physician of the recipient's restorative potential after any needed consultation with the qualified speech and language pathologist, that the recipient will improve significantly in a reasonable, and generally predictable, period of time; (e) The services are considered under accepted standards of medical practice to be a specific and effective treatment for the recipient's condition; and (f) The services are reasonable and necessary to the treatment of the recipient's condition. G. Supplies and equipment necessary to meet the needs of the recipient, including but not limited to: (1) ABD pads. (2) Adhesive strip bandages. (3) Adhesive tape (regular and non-allergenic). (4) Airways — oral and nasal. (5) Alcohol and alcohol sponges. (6) Ambu bags. (7) Antiseptics and cleansing agents (over-the-counter). (8) Applicators. (9) Bandages. (10) Beds, high-low, adjustable. (11) Bed pans and urinals. (12) Bed rails. (13) Bibs. (14) Body lotions (over-the-counter). (15) Canes. (16) Catheters (including Foley or other indwelling). (17) Catheter trays. (18) Chest or body restraints. (19) Clean catch kits. (20) Clinical medicine glasses — disposable or otherwise. (21) Cotton and cotton balls. (22) Covered water pitchers. (23) Crutches. (24) Dentifrices and denture adhesives. (25) Denture cups. (26) Deodorant (personal and room). (27) Diagnostic aids (Clinitest, Acetest, Hematest, Testape, etc.). (28) Dietary supplements (including tube feeding). (29) Disposable diapers or incontinency care pads. (30) Disposable wash cloths. (31) Douche apparatus. (32) Drainage bags and catheter tubing. (33) Emesis basins. (34) Enema apparatus. (35) Enemas and douches (including prepared). (36) Eye pads. (37) First aid supplies. (38) Gauzes. (39) Hot water bottles and covers. (40) Hydraulic lifts. (41) Ice bags. (42) Infusionarm boards. (43) Intermittent positive pressure breathing machines (I.P.P.B.). (44) Intravenous poles, portable. (45) Irrigation trays. (46) Levine tubes (plastic or regular). (47) Lubricants and oils. (48) Mouth washes. (49) Nasal atomizers. (50) Needles (cardiac, clysis or intravenous, permanent or disposable). (51) Oxygen for occasional and emergency use. Continuous oxygen is covered under the provisions of COMAR 10.09.18 Oxygen and Related Respiratory Equipment Services. (52) Oxygen masks, cannulas, catheters, and related equipment, including portable equipment for use with occasional or emergency oxygen. Equipment used for continuous use oxygen is covered under the provision of COMAR 10.09.18 Oxygen and Related Respiratory Equipment Services. (53) Paper tissues. (54) Personal toilet items (toothbrush, soap, shampoo, razor, shaving cream, sanitary pads). (55) Petroleum jelly. (56) Powder, medicated or non-medicated—over-the-counter. (57) Pumps, aspiration and suction. (58) Rectal tubes. (59) Rubber or plastic gloves and finger cots. (60) Rubber or plastic pants. (61) Rubber or plastic sheeting. (62) Rubber or sponge rings. (63) Sand bags. (64) Scales, including chair scales. (65) Sheepskin, natural or synthetic. (66) Slings. (67) Special mattresses for decubiti care. (68) Sphygmomanometers. (69) Stethoscopes. (70) Stryker and Foster frames. (71) Suction machines, gastric and tracheal. (72) Suction tubing. (73) Surgical dressings, including sterile sponges. (74) Suture removal kits. (75) Suture trays. (76) Syringes, plastic, glass, or bulb. (77) Tape removers. (78) Thermometers, oral, rectal, universal, bath. (79) Tongue depressors. (80) Tracheostomy equipment and supplies. (81) Traction equipment. (82) Trapeze and bed frame equipment. (83) Trays, cut-down. (84) Tubing. (85) Walkers and walkerettes. (86) Wheel chairs. H. Administration of enemas. I. Administration of oxygen. J. Back rubs. K. Decubiti care and over-the-counter medication. L. Colostomy, ileostomy, and nephrostomy care. M. Hand feeding or self-help eating devices. N. Incontinency care. O. Personal laundry. P. Personal toilet (routine shaving, hair washing and arranging, routine toenail clipping, adequate bathing). Q. Private room for isolation purposes. R. Special diets, including diabetic. S. Tray service. T. Tube feeding. U. Portable X-ray services. V. Respirator management in licensed comprehensive care beds which have been determined by the Department to meet the standards for respiratory care units under COMAR 10.07.02. W. Intravenous therapy and venipuncture. X. Noninvasive traction apparatus services (cervical, Buck's extension, pelvic). Y. Emergency resuscitation procedures, including coronary pulmonary procedures. Z. Restorative nursing care. AA. Physician-ordered physical restraints and protective devices. BB. Negative pressure wound therapy. #### Regulation .05 Limitations. *COMAR 10.09.10.05* The following are not covered: A. Services by an out-of-State nursing facility unless the Department and the nursing facility execute a provider agreement; B. Audiology services; C. Services reimbursed under Title XVIII of the Social Security Act; and D. Services for which payment is made directly to a provider other than the nursing facility. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.10.06* A. The Department of Human Services shall certify the recipient for financial eligibility, and the Department or its designee shall certify the recipient as requiring nursing facility services, except as provided in Regulation .26D of this chapter. B. The Department or its designee will certify as requiring nursing facility services only those financially eligible recipients requiring nursing facility services as defined in Regulation .01B of this chapter. #### Regulation .07 Prospective Rates. *COMAR 10.09.10.07* A. A provider shall be paid the prospective rate for nursing facility services as defined in Regulation .01B of this chapter plus the Nursing Facility Quality Assessment add-on identified in Regulation .11E of this chapter. B. When necessary, each facility’s per diem rate shall be reduced by the same percentage to maintain compliance with the Medicare upper payment limit requirement. C. Power wheelchairs and bariatric beds are not included in the prospective rate, but may be preauthorized for payment in accordance with COMAR 10.09.12. D. Support Surfaces. (1) Support surfaces are not included in the prospective rate. (2) A provider shall be paid a per diem rate for providing appropriate specialized support surfaces to patients with pressure ulcers or in recovery from myocutaneous flap or graft surgery for a pressure ulcer. (3) A Class A support surface is a mattress replacement which has been approved as a Group 2 Pressure Reducing Support Surface by the Medical Policy of the Medicare Durable Medical Equipment Regional Carrier. A Class A support surface shall be reimbursed per day at the Medicare Durable Medical Equipment Regional Carrier Maryland monthly fee cap, in effect at the beginning of the State fiscal year, for HCPCS Code E0277 multiplied by 12 and then divided by the number of days in the State fiscal year. (4) A Class B support surface is an air fluidized bed which has been approved as a Group 3 Pressure Reducing Support Surface by the Medical Policy of the Medicare Durable Medical Equipment Regional Carrier. A Class B support surface shall be reimbursed per day at the Medicare Durable Medical Equipment Regional Carrier Maryland monthly fee cap, in effect at the beginning of the State fiscal year, for HCPCS Code E0194 multiplied by 12 and then divided by the number of days in the State fiscal year. E. Negative pressure wound therapy is not included in the prospective rate, but is reimbursed in accordance with rates established under COMAR 10.09.12. Reimbursement shall include the cost of pumps, dressings, and containers associated with this procedure. F. Nursing facilities that are owned and operated by the State are not paid in accordance with the provisions of §A of this regulation, but are reimbursed reasonable costs based upon Medicare principles of reasonable costs as described at 42 CFR Part 413. Aggregate payments for these facilities may not exceed Medicare upper payment limits as specified at 42 CFR §447.272. If the Medicare upper payment limit is above aggregate costs for this ownership class, the State may elect to make supplemental payments to increase payments up to the Medicare upper payment limit. G. Final facility rates for the period July 1, 2024 through June 30, 2025 shall be each nursing facility’s quarterly rate, exclusive of the amount identified in Regulation .13A(2) of this chapter, increased by the budget adjustment factor of 2.703 percent, plus the Nursing Facility Quality Assessment add-on identified in Regulation .11E of this chapter and the ventilator care add-on amount identified in Regulation .13A(2) of this chapter when applicable. #### Regulation .08 Interim Working Capital Fund. *COMAR 10.09.10.08* A. A provider may request an allotment from the Interim Working Capital Fund if the facility for which an allotment is requested has not had any of the following deficiencies cited in any survey conducted by the Office of Health Care Quality during the calendar year preceding the calculation of the allotment, using the scope and severity matrix found in the Centers for Medicare and Medicaid Services State Operations Manual for Survey and Certification, Part 7, §7400E: (1) Two or more “G” level deficiencies; or (2) One or more “H” or higher level deficiencies. B. A provider operating a facility with any of the deficiencies described in §A of this regulation may be eligible for an allotment if the facility has undergone an arm's length change of ownership, as determined by the Department, since the latest survey that resulted in the deficiencies. C. The Department may deny an allotment from the Interim Working Capital Fund if the Department, based on sufficient information, concludes that the requesting provider is not able to repay the allotment on a timely basis. D. The maximum allotment for any provider shall be 0.015 times the total Medicaid payments to that provider in the prior State fiscal year. E. Recalculation. (1) In March of each year, the Department shall recalculate the maximum allotment based on Medicaid payments for the prior State fiscal year. (2) If the recalculated maximum allotment is: (a) Less than the amount the provider carried over from the prior year, the provider shall repay the difference to the Department within 30 days of the date the Department provides notice that a repayment is due; or (b) Greater than the amount carried over from the prior year, the provider may request the difference from the Department. F. Revocation. (1) The Department may revoke the allotment based on: (a) Quality of care violations; (b) Changes in business practice that are detrimental to Medicaid recipients; (c) Impending bankruptcy; or (d) Other good cause shown. (2) If the Department revokes the allotment, the provider shall repay the total allotment to the Department within 15 days of the notice of revocation. G. In order to obtain an allotment, the provider shall agree that it holds the allotment in constructive trust for the State subject to recoupment or immediate payment on demand by the State. H. The Interim Working Capital Fund expires on May 1, 2025. Providers shall repay all outstanding funds to the Department by May 1, 2025. The Department may grant repayment extensions, not longer than 60 days, under extraordinary circumstances. #### Regulation .09 Rate Calculation — Administrative and Routine Costs. *COMAR 10.09.10.09* A. The Administrative and Routine cost center includes: (1) Administrative expenses; (2) Medical records expenses; (3) Training expenses; (4) Dietary; (5) Laundry; (6) Housekeeping; (7) Operation and maintenance; and (8) Capitalized organization and start-up costs. B. The Department shall initially establish cost center prices for the rate period January 1, 2015 through June 30, 2015, and thereafter rebase the cost center prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or, if a significant change in provider behavior or costs has resulted in payment that is inequitable, across providers. The Department shall rebase based on the following steps: (1) The price database shall be established using the most recent desk reviewed Nursing Home Uniform Cost Report for each current provider, or the immediately prior owner of that nursing facility, that is available 2 months before the period for which prices are being established or rebased; (2) If no desk reviewed cost report is available, that provider shall be excluded from the price database; (3) The total cost center expenses for each cost report in the price database shall be adjusted from the midpoint of each cost reporting period to the midpoint of the rate year for which the price is being established based on the following steps: (a) A monthly market basket index shall be calculated based on the following calculations: (b) The index factor for each cost reporting period shall be calculated by dividing the index associated with the midpoint of the rate year by the index associated with the midpoint of the cost reporting period; and (c) The indexed costs shall be calculated as total cost center expenses times the index factor; (4) Each cost report's indexed Administrative and Routine costs shall be divided by the greater of total resident days or days at full occupancy times an occupancy standard calculated as the Statewide average occupancy, not including providers with occupancy waivers, plus 1.5 percent to arrive at the Administrative and Routine cost per diem; and (5) For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of Administrative and Routine cost per diems identified in §B(4) of this regulation to calculate the Administrative and Routine Medicaid day weighted median as follows: (a) Array the Administrative and Routine cost per diems for each geographic region from low to high; (b) For each Administrative and Routine cost per diem, identify the Medicaid days from the nursing facilities’ cost reports; (c) Calculate a cumulative Medicaid day total; and (d) Identify the median Administrative and Routine cost per diem as the Administrative and Routine per diem associated with the cumulative Medicaid days that first equals or exceeds half the number of total Medicaid days for the geographic region. C. The final price for Administrative and Routine costs for each reimbursement class shall be calculated as the geographic regional Medicaid day weighted median multiplied by 1.025. D. For years between periods when the prices are rebased, the final cost center price shall be adjusted by the change in the indexes as calculated in §B(3) of this regulation that correspond to midpoint of the prior rate year to the midpoint of the new rate year. E. The final Administrative and Routine rate for each nursing facility is the Administrative and Routine price for its reimbursement class. F. The reimbursement classes for the Administrative and Routine cost center are specified under Regulation .30A of this chapter. G. Kosher Kitchen Add-on. (1) Nursing facilities that maintain kosher kitchens and have Administrative and Routine costs in excess of the Administrative and Routine price in their reimbursement class that are attributable to dietary expense shall receive an add-on to its final price in an amount up to 15 percent of the median per diem cost for dietary expense in its reimbursement class. (2) For years between periods when the kosher kitchen add-ons are rebased, the kosher kitchen add-on shall be calculated as the prior year kosher kitchen add-on multiplied by the rate year monthly index divided by the prior year monthly index as identified in §B(3)(a) of this regulation. #### Regulation .10 Rate Calculation — Other Patient Care Costs. *COMAR 10.09.10.10* A. The Other Patient Care cost center includes: (1) Medical director administrative expenses; (2) Pharmacy; (3) Recreational activities; (4) Patient care consultant services; (5) Food cost (unprepared); (6) Social services; and (7) Religious services. B. The Department shall initially establish Other Patient Care prices for the rate period January 1, 2015, through June 30, 2015, and thereafter rebase the Other Patient Care prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. The Department shall rebase based on the following steps: (1) The indexed costs shall be calculated as set forth in Regulation .09B(1)—(3) of this chapter; (2) Each cost report's indexed Other Patient Care costs shall be divided by the actual days of nursing facility services to arrive at the Other Patient Care cost per diem; (3) For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of Other Patient Care cost per diems identified in §B(2) of this regulation to calculate the Other Patient Care Medicaid day weighted median using the method established in Regulation .09B(5) of this chapter; (4) The final price for Other Patient Care costs for each reimbursement class is calculated as the geographic regional Medicaid day weighted median multiplied by 1.07; and (5) For years between periods when the prices are rebased, the final price for Other Patient Care costs shall be calculated as set forth in Regulation .09D of this chapter. C. The final Other Patient Care rate for each nursing facility is the Other Patient Care price for its reimbursement class. D. The reimbursement classes for the Other Patient Care cost center are specified under Regulation .30B of this chapter. E. Kosher Kitchen Add-on. (1) Nursing facilities that maintain kosher kitchens and have Other Patient Care costs in excess of the Other Patient Care price in its reimbursement class that are attributable to food costs shall receive an add-on to its final price an amount up to 15 percent of the median per diem cost for food costs in its reimbursement class. (2) For years between periods when the kosher kitchen add-ons are rebased, the kosher kitchen add-on shall be calculated as the prior year kosher kitchen add-on multiplied by the rate year monthly index divided by the prior year monthly index as identified in Regulation .09B(3)(a) of this chapter. #### Regulation .11 Rate Calculation — Capital Costs. *COMAR 10.09.10.11* A. The Capital cost center includes: (1) Real estate taxes; and (2) Fair rental value. B. Final Capital Cost. (1) The determination of a provider's allowable final Capital per diem rate for the cost items under §A of this regulation is calculated as follows: (a) Appraise each facility at least every 4 years; (b) 2 months before the period for which final Capital rates are being calculated, determine the most recent appraisal for each facility; (c) Determine the cost report for each facility that covers the date of valuation of the appraisal identified in §B(1)(b) of this regulation, or, if a cost report covering the date of valuation has not been filed by the facility, determine the closest match to the date of valuation available 2 months before the period for which final Capital rates are being calculated; (d) Multiply the ending licensed nursing facility beds from the cost report in §B(1)(c) of this regulation, adjusted for accuracy using information available 2 months before setting the rate in this regulation, by the land per bed amount from the appraisal to calculate a total land amount; (e) Sum the total land amount, building, and equipment; (f) Divide the total appraisal amount by the number of ending licensed nursing facility beds, under §B(1)(d) of this regulation, to determine an appraised value per bed; (g) Apply a maximum appraised value per bed of $120,000; (h) Multiply the final appraised value per bed times the number of ending licensed nursing facility beds, under §B(1)(d) of this regulation, to determine the facility’s gross value; (i) For facilities in Baltimore City, multiply the facility’s gross value by 10 percent to determine the facility’s annual fair rental value; (j) For facilities in all jurisdictions except Baltimore City, multiply the facility’s gross value by 8 percent to determine the facility’s annual fair rental value; (k) Divide the facility’s annual fair rental value by the greater of actual resident days, or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter, to establish a fair rental value per diem rate; (l) Divide real estate taxes obtained from the most recent desk reviewed cost report available 2 months before the start of the rate year by the greater of actual resident days, or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter, to establish a real estate tax per diem rate; and (m) Sum the fair rental value and the real estate tax per diem rates. (2) The appraisal may not include any value associated with a Certificate of Need for nursing home beds. C. The final Capital rate for nursing facilities that have a change in the number of licensed beds or have replacement beds placed into operation during a State fiscal year shall not be recalculated as a result of that change until such time as an appraisal incorporating the changes is selected according to §B(1)(b) of this regulation and used in the facility’s rate calculation. D. The provider may protest the appraisal by submitting written notification to the Department within 90 days of receipt of the appraisal. If the protest cannot be resolved administratively, the provider may appeal under Regulation .34 of this chapter. E. Nursing facilities that are required to pay an assessment in accordance with COMAR 10.01.20.02 shall receive a Quality Assessment add-on calculated as follows: (1) Sum the assessed days reported on the Nursing Facility Quality Assessment Payment Reporting Forms for the quarters covering the calendar year preceding the rate year; (2) Multiply the assessed days by the assessment rate established for the rate quarters; and (3) Divide the total assessed amount by the sum of the total patient days reported on the quarterly Nursing Facility Quality Assessment Payment Reporting Forms. #### Regulation .12 Rate Calculation — Nursing Service Costs. *COMAR 10.09.10.12* A. The Nursing Service cost center includes all nursing expenses related to the direct provision of patient care. B. The Department shall initially establish Nursing Service prices for the rate period January 1, 2015, through June 30, 2015, and thereafter rebase the Nursing Service prices between every 2 and 4 rate years. Prices may be rebased more frequently if the Department determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. The Department shall rebase based on the following steps: (1) The indexed costs shall be calculated as set forth in Regulation .09B(1)—(3) of this chapter; (2) Each cost report's indexed Nursing Service costs shall be divided by the actual days of nursing care to arrive at the indexed Nursing Service cost per diem; (3) The indexed Nursing Service cost per diem shall be normalized to the Statewide average case mix index by multiplying the indexed Nursing Service cost per diem by the facility’s normalization ratio calculated as the Statewide average case mix index divided by the cost report period case mix index rounded to four decimals which creates the Normalized Nursing Cost per diem; (4) For each reimbursement class, each cost report's Medicaid resident days shall be used in the array of cost per diems identified in §B(3) of this regulation to calculate the Medicaid day weighted median using the method established in Regulation .09B(5) of this chapter; (5) The final price for Nursing Service costs for each reimbursement class is calculated as the geographic regional Medicaid day weighted median Nursing Service cost multiplied by 1.0825; and (6) For years between periods when the prices are rebased, the final price for Nursing Service costs shall be adjusted as set forth in Regulation .09D of this chapter. C. The final Nursing Service rate for each nursing facility for each quarter is calculated as follows: (1) Determine the Nursing Service price for the facility’s geographic region; (2) Calculate an initial nursing facility rate by multiplying the price by the facility average Medicaid case mix index divided by the Statewide average case mix index; (3) Calculate a Medicaid adjusted Nursing Service cost per diem by multiplying the per diem identified under §B(2) or C(5) of this regulation by the Medicaid case mix adjustment ratio calculated as the facility average Medicaid case mix index divided by the cost report period case mix index rounded to four decimals; (4) Calculate the final Nursing Service rate as the initial nursing facility rate reduced by any positive difference between 95 percent of the initial nursing facility rate and the Medicaid adjusted Nursing Service cost per diem; and (5) For years between periods when the prices are rebased, the indexed Nursing Service cost per diem identified under §B(2) of this regulation shall be adjusted as set forth in Regulation .09D of this chapter. D. The reimbursement classes for the Nursing Service cost center are specified under Regulation .30C of this chapter. E. Resident Rosters. (1) A nursing facility shall electronically transmit MDS assessment information in a complete, accurate, and timely manner. (2) The Department shall provide a preliminary resident roster to a nursing facility based on the facility’s transmitted MDS assessment information for a calendar quarter on the fifth day of the second month following the end of the calendar quarter, provided that the nursing facility has transmitted the MDS assessment information by the 15th day following the end of the calendar quarter. (3) The distribution of the preliminary resident roster shall serve as notice of the MDS assessments transmitted and provide an opportunity for the nursing facility to correct and transmit any missing MDS record. (4) The Department shall provide a final resident roster to a nursing facility based on the facility’s transmitted MDS assessment information for a calendar quarter, provided that the nursing facility has transmitted the MDS assessment information by the 25th day of the second calendar month following the end of the calendar quarter. (5) The Department may not consider MDS assessment information for the purpose of reimbursement rate calculations for a calendar quarter that is not submitted by the 25th day of the second calendar month following the end of the calendar quarter, except as provided in §E(6) of this regulation. (6) The Department may only grant an exception to compliance with the electronic MDS assessment transmission due dates if the delay has been caused by fire, flood, act of God, or other good cause. (7) The Department or its designated contractor shall distribute preliminary and final resident rosters according to the following schedule: F. Case Mix Index Calculation. (1) The Department shall use the resource utilization group to adjust Nursing Service costs and to determine each nursing facility’s Nursing Service rate component. (2) The Department shall adjust a nursing facility's case mix reimbursement rates quarterly based on the change in case mix of each facility according to the following schedule: (a) The facility average Medicaid case mix index obtained from January 1 through March 31 shall be used to adjust rates effective July 1 through September 30 of the same calendar year; (b) The facility average Medicaid case mix index obtained from April 1 through June 30 shall be used to adjust rates effective October 1 through December 31 of the same calendar year; (c) The facility average Medicaid case mix index obtained from July 1 through September 30 shall be used to adjust rates effective January 1 through March 31 of the following calendar year; and (d) The facility average Medicaid case mix index obtained from October 1 through December 31 shall be used to adjust rates effective April 1 through June 30 of the following calendar year. (3) If the Department or its contractor determines that a nursing facility has delinquent MDS resident assessments, for purposes of determining both facility CMI averages, the assessments shall be assigned the case mix index associated with the RUG group “BC1” or its successor. (4) A delinquent MDS shall be assigned a CMI value equal to the lowest CMI in the RUG classification system, or its successor. (5) For each resident roster quarter, the Department shall calculate a Statewide average case mix index and a Statewide average Medicaid case mix index from all final resident rosters. (6) A Medicaid case mix index equalizer shall be used to prevent any aggregate increase or decrease in expected State fiscal year Medicaid program expenditures for the rate quarters beginning every October, January and April, as follows: (a) The Statewide average Medicaid case mix index for the July rate quarter shall be divided by the Statewide average Medicaid case mix index for the rate quarter identified in §F(2) of this regulation to determine the Medicaid case mix index equalizer for the quarter; (b) Each facility average Medicaid case mix index for use in the rate quarter for each nursing facility shall be multiplied by the Medicaid case mix index equalizer to result in a facility Medicaid equalized case mix index; and (c) The facility Medicaid equalized case mix index shall be used in place of the facility Medicaid case mix index in the calculation of the initial and final Nursing Service rate in §C of this regulation for every October, January, and April rate quarter. (7) To determine cost report period case mix index for cost reporting periods starting before the midpoint of a calendar quarter, the associated quarterly resident roster period CMIs are used. If a cost report end date is before the midpoint of a calendar quarter, the associated quarterly resident roster period CMIs are not used. G. Assignment of Different Geographic Region. (1) The Department may approve a provider's request to be included in a different Nursing Service cost center geographic region of this chapter upon review of sufficient documentation. Documentation shall show that the assigned geographic region is not appropriate for the provider and that economic conditions have placed the provider directly in competition with facilities in a geographic region other than the one to which the provider has been assigned by the Department. Payment of higher wages, or higher total expenditures, is not in itself sufficient to demonstrate that the provider is subject to economic conditions different from other providers in its reimbursement class. (2) All approved waivers for geographic regions shall be effective for the following State fiscal year for the purpose of establishing the final Nursing Service rate in §C of this regulation, (3) Nursing Service prices established in §B of this regulation shall be based on all facilities in a geographic region that do not have an approved waiver to be included in a different geographic region plus facilities with an approved waiver to receive prices in that geographic region. #### Regulation .13 Ventilator Care Nursing Facilities. *COMAR 10.09.10.13* Nursing facilities with licensed nursing facility beds, which have been determined by the Department to meet the standards for ventilator care under COMAR 10.07.02, shall be reimbursed as follows: A. Services for residents receiving ventilator care shall be reimbursed as follows: (1) The Nursing Service rate identified in Regulation .12 of this chapter shall be calculated with a facility average Medicaid case mix index that includes only residents receiving ventilator care; and (2) An amount of $285 shall be added to the total prospective rate; B. The facility average Medicaid case mix index for rates under §A of this regulation are not subject to the Medicaid case mix index equalizer adjustment in Regulation .12F(6) of this chapter; C. Nursing facilities adding ventilator care services for the first time, which have been determined by the Department to meet the standards for ventilator care under COMAR 10.07.02, shall be reimbursed as described in §A of this regulation, except that the facility average Medicaid case mix index is assumed to be that of RUG classification ES3 (or its future equivalent); D. The facility should request this rate from the Department at least 60 days before the opening of the ventilator unit; E. For years between periods when the Nursing Services prices are rebased, the final price for Ventilator costs shall be adjusted as set forth in Regulation .09D of this chapter; and F. For residents not receiving ventilator care, the Initial Facility Nursing Service rate identified in Regulation .12 of this chapter shall be calculated with a facility average Medicaid case mix index that excludes residents receiving ventilator care. #### Regulation .14 Pay-for-Performance — Eligibility. *COMAR 10.09.10.14* In order to be eligible to receive funds through the pay-for-performance program under the provisions of Regulations .15—.19 of this chapter: A. The provider shall be subject to quality assessment under COMAR 10.01.20; and B. During the 1 year period ending March 31 of the prior State fiscal year, the provider may not have been: (1) Identified by the federal Centers for Medicare and Medicaid Services as a special focus facility; (2) Denied payment for new admissions by the Department; or (3) Identified by the Department as delivering substandard quality of care. #### Regulation .15 Pay-for-Performance — Quality Measures. *COMAR 10.09.10.15* A. Providers shall receive a composite score based on the following: (1) Staffing levels, as described in §B of this regulation, shall comprise 20 percent of each facility’s score; (2) Staffing stability, as described in §C of this regulation, shall comprise 15 percent of each facility’s score; (3) Maryland Health Care Commission Nursing Facility Family Survey, as described in §D of this regulation, shall comprise 30 percent of each facility’s score; (4) Minimum Data Set Clinical Quality Indicators, as described in §E of this regulation, shall comprise 30 percent of each facility’s score; and (5) Staff immunization survey, as described in §F of this regulation, shall comprise 5 percent of each facility’s score. B. Staffing Levels. (1) Staffing and hours of work shall be determined using the Payroll-Based Journal data for the 9-month period ending March 31 of each fiscal year. (2) A facility’s average staffing level shall be determined from its most recent data reported in accordance with §B(1) of this regulation. Total staff hours shall be divided by average daily census during the period specified in §B(1) of this regulation to establish the facility’s average daily staffing. (3) A facility’s average acuity shall be determined based on the facilities Minimum Data Set Resource Utilization Groups (RUG) during the 6-month period ending December 31 of the most recent State fiscal year. To establish expected staffing hours, each RUG group will be multiplied by the corresponding hours under Regulation .31B of this chapter and divided by the total days of care during the same period. (4) The result from §B(3) of this regulation shall be multiplied by 1.26555 to establish the facility’s staffing goal. (5) The facility’s staffing level from §B(2) of this regulation shall be divided by the facility’s staffing goal from §B(4) of this regulation to determine a score based on its percentage of the goal. A facility staffing exceeding its goal shall be scored at 100 percent. (6) Providers shall receive 0—20 points based upon the scoring methodology described under Regulation .16 of this chapter. C. Staff Stability. (1) On or before May 31 of the fiscal year, nursing facilities, excluding continuing care retirement communities and facilities with fewer than 45 beds, shall report data on individual nursing staff members’ length of employment using a format and procedures designated by the Department. This data shall include all nursing staff employed by the facility during the pay period that includes March 31 of the fiscal year. (2) Providers that fail to comply with §C(1) of this regulation shall receive 0 points. (3) Staff stability is based upon dates of employment for nursing staff reported in accordance with §C(1) of this regulation. (4) Staff stability shall be determined by the percentage of staff employed by the facility for 2 years or longer at the time of the report. (5) Providers shall receive 0—15 points based upon the scoring methodology described under Regulation .16 of this chapter. D. Family Satisfaction. (1) Family satisfaction shall be determined based on results from the facility’s most recent Nursing Facility Family Survey administered by the Maryland Health Care Commission. (2) Providers shall receive 0—30 points based upon the scoring methodology described under Regulation .16 of this chapter, as follows: (a) 0—6 points shall be based upon questions regarding general satisfaction; and (b) 0—24 points shall be based on several categories of questions regarding specific aspects of care and environment in the nursing facility. E. Minimum Data Set Clinical Quality Indicators. (1) Providers shall receive scores for the 3-month period ending December 31 of the most recent prior State fiscal year based on the following quality indicators for long-stay residents from the Minimum Data Set published by the federal Centers for Medicare and Medicaid Services: (a) Percent of High-Risk Residents Who Have Pressure Sores; (b) Percent of Residents with a Fall Resulting in Major Injury; (c) Percent of Residents Who Have/Had a Catheter Inserted and Left in Their Bladder; (d) Percent of Residents with a Urinary Tract Infection; (e) Percent of Long-Stay Residents Given Influenza Vaccination During the Flu Season; and (f) Percent of Long-Stay Residents Who Were Assessed and Given Pneumococcal Vaccination. (2) Providers shall receive 0—5 points for each quality indicator based on the scoring methodology described under Regulation .16 of this chapter. F. Staff Immunizations. (1) Providers shall receive a score based on the percentage of nursing facility staff, which includes all staff classifications, that have been vaccinated against seasonal influenza. (2) Providers shall receive 0, 2, or 5 points for this quality measure. Facilities shall submit data to the Department regarding all individuals employed or contracted by the facility during the period September through April 15. (3) Benchmark. (a) The benchmark for staff vaccinations is 90 percent. (b) Nursing facilities that achieve the benchmark for at least 90 percent but less than 95 percent for seasonal flu shall receive 2 points. (c) Nursing facilities that meet or exceed the benchmark of 95 percent for seasonal flu shall receive 5 points. (d) Facilities with less than 90 percent may not receive points for this quality measure. #### Regulation .16 Pay-for-Performance — Scoring Methodology. *COMAR 10.09.10.16* A. Facilities that are eligible for pay-for-performance under Regulation .14 of this chapter shall receive a score for each quality measure described in Regulation .15 of this chapter. B. For the quality measures described in Regulation .15B—E of this chapter, a facility is ranked and awarded points as follows: (1) The highest ranked facility receives 100 percent of the points available; (2) The median score, weighted by total days of care, receives 50 percent of the points available; (3) Zero points would be received by any facility whose raw score is below the median by an amount equal to or greater than the difference between the highest score and the median score; and (4) All other facilities will receive points proportionate to where the score falls within the range between the highest and zero. C. Points for each quality measure are summed. #### Regulation .17 Pay-for-Performance — Payment for Improvement. *COMAR 10.09.10.17* A. In order to be eligible for improvement payment, a facility: (1) Shall meet the eligibility criteria specified in Regulation .14 of this chapter; (2) Shall be eligible and receive a composite score during the current fiscal year and the prior fiscal year; and (3) May not be receiving a payment based upon its score as described in Regulation .19C of this chapter. B. Facilities shall be ranked according to the greatest point increase compared with the prior fiscal year. #### Regulation .18 Pay-for-Performance — Scoring Data Review. *COMAR 10.09.10.18* A. The Department shall report scores for pay-for-performance quality measures in Regulation .15 of this chapter, on or about July 1 of each year, based on data compiled during the prior fiscal year. B. A facility shall have 30 days from the date of the report to review and comment on performance data. C. If the Department determines that there are any errors in transcription of the data provided to the Department, or calculation of scores, ranks, or payment amounts, all facilities shall be rescored and revised scores shall be distributed. A final 30-day review period shall be allowed if the rescoring results in significant modifications. #### Regulation .19 Pay-for-Performance — Payment Distribution. *COMAR 10.09.10.19* A. Beginning State fiscal year 2021, and each year thereafter, 1 percent of the budget allocation for nursing facility services shall be distributed based on pay-for-performance scores. B. Eighty-five percent of the amount identified in §A of this regulation shall be distributed to the highest scoring facilities, representing 40 percent of the eligible days of care, in accordance with the methodology described in Regulation .16 of this chapter. C. Funds shall be distributed among the facilities identified in §B of this regulation, based on the facility’s relative score, such that the highest-scoring facility shall receive twice the amount per day as the lowest-scoring facility receiving payment. D. Fifteen percent of the amount identified in §A of this regulation shall be distributed to the facilities that qualify for payment for improvement in accordance with Regulation .17 of this chapter. E. Funds shall be distributed among the facilities included in §D of this regulation, based on a facility’s relative point increase from the prior fiscal year, such that the facility with the greatest point increase shall receive twice the amount per day as the facility with the smallest point increase. F. A facility shall receive a lump-sum payment based on the per diem amount determined in accordance with §C or E of this regulation, multiplied by the facility’s Medicaid days of care in the facility’s most recent cost report, not to exceed 1 year. #### Regulation .20 Payment Procedures — Out-of-State Facilities. *COMAR 10.09.10.20* A. Out-of-State nursing facilities that are not special rehabilitation nursing facilities and do not meet the exception to cost reporting requirements set forth in Regulation .21M of this chapter shall be reimbursed at a rate that is the lesser of: (1) The average Statewide quarterly rate identified by Regulation .07 of this chapter for in-State nursing facilities minus the quality assessment; and (2) The out-of-State facility’s Medicaid per diem rate provided by the state in which the facility is located, or, if the state provides the facility with more than one Medicaid per diem rate, the facility’s lowest per diem rate. B. Out-of-State nursing facilities that are not special rehabilitation nursing facilities and do meet the exception to cost reporting requirements set forth in Regulation .21M of this chapter shall be reimbursed the average Statewide quarterly rate identified by Regulation .07 of this chapter for in-State nursing facilities minus the quality assessment. C. Out-of-State special rehabilitation nursing facilities shall be reimbursed by the Program when the following conditions are met: (1) The facility is accredited by the Commission on Accreditation of Rehabilitation Facilities; (2) The facility is licensed and certified as a nursing facility; and (3) Services for which reimbursement is requested have been preauthorized by the Program. D. The rate for each resident in an out-of-State special rehabilitation nursing facility shall be negotiated to: (1) Be less than the cost of available institutional alternatives; and (2) Not exceed the home state's Medicaid rate for the same service by the same provider if the provider participates in its home state Medicaid program. #### Regulation .21 Cost Reporting. *COMAR 10.09.10.21* A. The provider shall include, for purposes of cost finding, direct and indirect costs applicable to recipient care. B. The provider shall specifically identify, in the cost report, costs associated with related organizations. C. The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. This system of accounts will provide as a minimum: (1) Maintenance of a chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements; (2) Proper reference to supporting invoice, voucher, or other form of original evidence; (3) Maintenance of an appropriate time reporting system for all personnel and proper payroll authorizations and vouchers; (4) Provision for payment by check (when financial transactions involve numerous small expenditures, an imprest petty cash fund may be established, provided adequate supporting vouchers are maintained); (5) Maintenance of records on all assets capitalized and depreciation on the assets; (6) Maintenance of appropriate records of patient days by level of care; (7) Maintenance of records on an accrual basis; (8) Maintenance of a daily midnight bed census by recipient name in a form prescribed by the Department (use of the prescribed form may be waived by the Department or its designee where a provider demonstrates the ability to maintain a superior system of census information); and (9) Maintenance of other records as required by the Department. D. The provider shall keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours. Upon request by the Department or its designee, documentation of costs shall be made available by the provider during the course of verification. The provider shall have 30 days from the date of the request to provide documentation for undocumented costs. Costs for which documentation is not provided within the 30 days shall be deemed not allowable. The Department may grant, in writing, an extension of time upon written demonstration by the provider of good cause. Records shall be retained for 6 years after the month the cost report to which the materials apply is filed with the Department or its designee. E. Financial and Statistical Data Required. (1) The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. (2) If reports are not received within 3 months and an extension has not been granted, the Department shall reduce the per diem rate by 3 percent for services provided during the calendar month after the month in which the report is due and any subsequent calendar month through the month during which the report has been submitted. (3) If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. (4) A 1-month extension will be granted upon written request in advance by the provider. The Department may not grant an extension longer than 1 month unless the delay in filing the report has been caused by fire, flood, or act of God, and an extension is not allowed past March 31 after the calendar year during which the provider's fiscal year ended unless the report cannot be submitted by that date due to fire, flood, or act of God. F. When a report is not submitted by the last day of the sixth month after the end of the provider's fiscal year, the Department shall impose one or more sanctions as provided for in Regulation .33 of this chapter. G. For purposes of §§E and F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. H. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. I. The Department, at its option, may request an additional cost report from a provider when a: (1) Change in the location of a provider's operation occurs; or (2) Significant change occurs that would affect the appraised value of a facility, such as an increase in the number of beds by more than 10 percent. J. If the Department exercises its option under the provisions of §I of this regulation, the period covered by the two reports in the specific provider’s fiscal year shall be divided as follows: (1) Beginning of fiscal year to date of change; and (2) Date of change through the end of the fiscal year. K. Except as indicated in §L of this regulation, administrative and routine, other patient care, and capital costs incurred by the provider exclusively for providing ventilator care are not allowed in these cost centers, but are allowable nursing service costs. L. For any provider who provides ventilator care on 50 percent or more of its Maryland Medical Assistance days of care, all costs incurred by the provider exclusively for providing ventilator care are not allowable costs. M. A provider which renders a minimal number of Maryland Medical Assistance days of care may not be subject to cost reporting or field verification requirements for a specified fiscal period when the following criteria are met: (1) The provider bills the Maryland Medical Assistance Program for less than 1,000 Maryland Medical Assistance days of care during the provider's fiscal period; and (2) The provider gives notice to the Program within 3 months after the end of the provider's fiscal period of the intent to not file a cost report for that period. N. The notice required in §M(2) of this regulation shall include: (1) An assurance that the provider billed the Medical Assistance Program for less than 1,000 days of care in the fiscal period; and (2) A statement that the provider agrees to accept as final reimbursement the average rate paid to all other nursing facilities in the facility’s geographic region identified in Regulation .30A of this chapter, minus the quality assessment add-on for facilities that are exempt from Nursing Facility Quality Assessment identified in COMAR 10.01.20. O. A provider that does not incur costs for over-the-counter drugs on behalf of its private pay residents may adjust its report in order to ensure final reimbursement that more accurately reflects its costs for Medicaid days of care. The provider shall divide its costs by Medicaid and other government-paid days, multiply the quotient by its private pay days of care, and report the product as an adjustment to its over-the-counter drug costs. P. Out-of-State facilities are not subject to cost reporting requirements #### Regulation .22 Desk Reviews and Field Verification. *COMAR 10.09.10.22* A. Desk Reviews. (1) The Department or its designee may conduct a desk review of the costs before establishing the Administrative and Routine and Other Patient Care prices and Nursing Service rates. (2) The Department or its designee shall notify each provider participating in the Program if any adjustments resulted from the desk review. (3) Desk review adjustments shall be used in the computation of any future rate for the facility or the facility’s future owner that is based on the reported or desk reviewed costs, until the rate is rebased. B. Field Verifications. (1) The Department or its designee may conduct a field verification of the reported or desk reviewed costs affecting reimbursement rates. (2) The Department or its designee shall notify each provider participating in the Program of the results of the field verification. (3) Field audit adjustments shall be used in the computation of any future rate for the facility or the facility’s future owner that is based on the reported or desk reviewed costs, until the rate is rebased. (4) Field audit adjustments shall be used in the recomputation of any past rate for the facility or the facility’s past owner that is based on the reported or desk reviewed costs. (5) If the recomputation of rates results in a rate that differs more than 2 percent from the initial rate computation excluding the quality assessment, the Department shall initiate an adjustment for the impacted service dates within 60 days after the notification described in §B(2) of this regulation. (6) Field audit adjustments shall only affect the facility’s rates and do not affect prices or rates for other facilities within the geographic region. (7) Out-of-State facilities are not subject to field verification requirements. #### Regulation .23 Third Party Liability Reviews and Audits of Nursing Facilities. *COMAR 10.09.10.23* A. Quarterly Reports of Credit Balances. A provider shall report the credit balances of the nursing facility to the Department on a quarterly basis. B. Third Party Liability Review. The Department shall conduct a third party liability review of the reports of the credit balances provider under §A of this regulation. C. Third Party Liability Audit of Random Sample. The Department or its designee may conduct a third party liability audit of a random sample of the reports of credit balances reviewed under §B of this regulation. D. Third Party Liability Audit of Noncompliant Nursing Facility. (1) Subject to §D(2) of this regulation, the Department or its designee may conduct a third party liability audit of a nursing facility that is found to be noncompliant under §B of this regulation. (2) In conducting the third party liability audit, the Department or its designee may only review the financial information of the nursing facility for the 2-year period immediately before the first day of the audit period in which the nursing facility was found to be noncompliant. E. Appeal Rights of Nursing Facility. (1) A provider may appeal the results of a final report of a third party liability audit by filing written notice with the Department within 30 days after the provider receives the final report from the Department. (2) An individual at the Department who did not participate in the final report shall: (a) Review the appeal and contact a provider representative, if clarification is necessary; and (b) Issue a report that either revises or concurs with the final report of the third party audit. (3) A provider may appeal the results of the report issued by the Department under §E(2) of this regulation by filing written notice with the Nursing Home Appeal Board within 30 days of receipt of the report. (4) If the provider does not appeal the results of the third party liability audit by filing written notice with the Department: (a) The amount due as set out in the final report shall be paid to the Department within 60 days of the receipt by the provider of the results of the third party liability audit; or (b) On or after the 61st day, after receipt by the provider of the results of the third party liability audit, the Department may withhold the amount as set out in the final report from future payments due the provider by the Department unless an agreed on payment plan has been entered into by the Department and the provider. (5) If the provider appeals the results of a final report of a third party liability audit as authorized under §E(1) of this regulation, interest shall be charged on the amount appealed and shall continue until date of payment. The interest rate shall be based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. (6) After a decision adverse to the provider by the Nursing Home Appeal Board and written notice to the provider of that decision by the Department: (a) The amount determined to be due to the Department as a result of the third party liability audit shall be paid to the Department with accrued interest due; or (b) On or after the 61st day, the Department may withhold the amount due pursuant to the decision of the Nursing Home Appeal Board from future payments due the provider by the Department unless an agreed on payment plan has been entered into by the Department and the provider. #### Regulation .24 MDS Validation and Ventilator Care Validation. *COMAR 10.09.10.24* A. MDS Validation. (1) In order to validate that the Nursing Service rate is supported by medical record documentation, accurately coded and submitted, the Department shall conduct periodic MDS validation reviews, which shall: (a) Compare the MDS assessment coding with the corresponding medical record documentation to determine unsupported MDS assessments; (b) Determine the completeness, timeliness, and accuracy of resident MDS assessments identified on the resident roster; and (c) Determine the completeness and accuracy of the resident payment source listed on the resident roster. (2) Findings from the MDS validation may be used to adjust a nursing facility’s per diem payment rate to reflect the validated case mix index used in the rate setting process. B. Ventilator Care Validation. (1) In order to validate that days paid for residents that meet the requirements for ventilator care are supported by medical record documentation of the need for ventilator care services, the Department shall conduct a periodic ventilator care validation. (2) Findings from the ventilator care validation shall be used to recoup payments for days not supported by medical record documentation. #### Regulation .25 New Nursing Facilities, Replacement Facilities, and Change of Ownership. *COMAR 10.09.10.25* A. The Department shall establish rates for new nursing facilities, replacement facilities, and nursing facilities with a change of ownership as outlined in §§B—D of this regulation. B. New Nursing Facilities. (1) Until such time as an appraisal for the new facility is available as set forth in Regulation .11B(1)(b) of this chapter, the fair rental value per diem rate shall be based on the lower of the facility’s construction costs plus the assessed land value divided by the number of licensed beds, or the maximum appraised value per bed in Regulation .11B(1)(g) of this chapter. (2) A new nursing facility shall be assigned the Statewide average Medicaid CMI until assessment data submitted by the nursing facility is used in a quarterly rate determination. (3) The nursing facility shall be assigned to the appropriate geographic region, as specified under Regulation .30 of this chapter, for purposes of assigning the Nursing Service rate, the Other Patient Care price, and the Administrative and Routine price. (4) The geographic region price for Nursing Service costs shall be multiplied by the new nursing facility’s Medicaid CMI until there is a nursing facility cost report used in the rebasing process. (5) The fair rental value per diem rate shall use days as the greater of total estimated resident days or days at full occupancy times an occupancy standard calculated under Regulation .09B(4) of this chapter and the maximum bed value identified in Regulation .11B(1)(g) of this chapter. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the fair rental value per diem rate shall be calculated using estimated resident days. At the completion of the waiver period, either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. (6) Upon providing the real estate bills to the State which incorporate the new construction at least 15 days before the start of operations or at least 15 days before the beginning of any calendar quarter, the real estate tax per diem rate shall be calculated in accordance with Regulation .11B(1)(l) of this chapter. This amount shall be used for the period from the time of submission until the next facility cost report is filed. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the real estate tax per diem rate shall be calculated using estimated resident days. At the completion of the waiver period, either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. (7) For the first 2 State fiscal rate setting years, or portions thereof, new nursing facilities that are required to pay an assessment in accordance with COMAR 10.01.20.02 shall receive a Quality Assessment add-on calculated as follows: (a) Estimate the assessed days to be reported on the Nursing Facility Quality Assessment Payment Reporting Forms for the quarters covering the upcoming State fiscal rate setting year or portion thereof; (b) Multiply the estimated assessed days by the assessment rate anticipated for the rate quarters; and (c) Divide the total estimated assessed amount by the sum of the total estimated patient days. At the completion of either of these first two rate setting periods, either the State or the facility may initiate a settlement payment should the estimates vary from the actual by more than 10 percent. C. Replacement Facilities. (1) Until such time as an appraisal for the replacement facility is available as set forth in Regulation .11B(1)(b) of this chapter, the fair rental value per diem rate shall be based on the lower of the facility’s construction costs plus the assessed land value divided by the number of licensed beds, or the maximum appraised value per bed in Regulation .11B(1)(g) of this chapter. (2) The fair rental value per diem rate shall use days as the greater of total estimated resident days or days at full occupancy times an occupancy standard calculated as the Statewide average under Regulation .09B(4) of this chapter. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter the fair rental value per diem rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. (3) Upon providing the real estate bills to the State, which incorporate the new construction, at least 15 days before the start of operations or at least 15 days before the beginning of any calendar quarter, the real estate tax per diem rate shall be calculated in accordance with Regulation .11B(1)(l) of this chapter. This amount shall be used for the period from the time of submission until the next facility cost report is filed. For the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter, the real estate tax per diem rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. (4) The replacement facility fair rental value rate shall be effective beginning on the date the replacement facility meets the requirements in Regulations .02 and .03 of this chapter. (5) Except for the fair rental value portion of the Capital rate, the replacement facility shall be paid exactly as the original facility. (6) The replacement facility rates shall be based on the original facility’s average Medicaid case mix index and cost report costs. D. Change of Ownership. (1) Except when the Program agrees to a shorter notification period, when there is an anticipated change of ownership of a provider, not less than 30 days before the date of the change of ownership: (a) The provider shall: (i) Notify the Program of the anticipated change of ownership; and (ii) If the provider has not filed for bankruptcy, post an indemnity bond or a standby letter of credit, or provide assurance satisfactory to the Program that the purchaser shall assume and be responsible for all financial obligations of the existing provider; and (b) The purchaser shall: (i) Notify the Program of the intent to engage in a change of ownership and the desire to enroll in the Program; (ii) Submit a provider application and execute a provider agreement with the Department; and (iii) If the provider has filed for bankruptcy, post an indemnity bond or a standby letter of credit, or provide some assurance satisfactory to the Program that the purchaser shall assume and be responsible for all financial obligations of the existing provider. (2) Indemnity Bond or Standby Letter of Credit. (a) The indemnity bond or standby letter of credit required by §D(1)(a)(ii) or (b)(iii) of this regulation shall be in the amount of: (i) 10 percent of the Program billings for each unsettled fiscal period prior to January 1, 2015 outstanding; (ii) All unpaid amounts due and owing the Program for each settled fiscal period before January 1, 2015; (iii) 5 percent of the Program billings for the most recent annual fiscal period; and (iv) All debt owed by the provider to the Interim Working Capital Fund under Regulation .08 of this chapter. (b) The indemnity bond or standby letter of credit obligation under §D(2)(a) of this regulation shall remain in effect until all financial liabilities are resolved. (c) If a court of competent jurisdiction discharges the debt of a bankrupt provider, the Program shall release to the purchaser the difference between the indemnity bond or standby letter of credit required under §D(1)(b)(iii) of this regulation and the amount of the financial obligation discharged by the court. (3) The purchaser shall submit a provider application and execute a provider agreement with the Department before being assigned a prospective rate. (4) The new owner shall assume the old owner’s facility average Medicaid case mix index and cost reports. (5) The new owner shall be paid at the same rates as the old nursing facility provider except for the period of time the facility is operating under a waiver of occupancy granted in accordance with Regulation .26F of this chapter in which the Capital rate shall be calculated using estimated resident days. At the completion of the waiver period either the State or the facility may initiate a settlement payment should the estimate vary from the actual by more than 10 percent. #### Regulation .26 Selected Costs — Allowable. *COMAR 10.09.10.26* A. Recreational Services. The allowable costs of recreational services of a facility shall be based on an hourly or salary rate, not on a fee-for-service basis. B. Over-the-Counter Drugs. The cost of over-the-counter drugs is not to exceed the average wholesale price plus 50 percent, or the usual selling price, whichever is lower. C. Leave of Absence. The Department shall pay the sum of the rates identified in Regulations .09—.11 of this chapter, less patient resources for the cost of reserving beds for recipients for therapeutic home visits or participation in State-approved therapeutic or rehabilitative programs, subject to the following conditions: (1) The recipient's plan of care provides for the absence; (2) The leave of absence does not exceed 18 days during any calendar year; (3) The recipient's attending physician shall complete the physician's authorization form not more than 30 days before the recipient's anticipated leave of absence; and (4) The facility submits the physician's authorization form to the Department with the facility's invoice, which covers the month in which the leave of absence occurred. D. Administrative Days. The Department shall pay the sum of the rates identified in Regulations .09—.11 of this chapter, and 50 percent of the rate identified in Regulation .12 of this chapter, less patient resources for administrative days, documented on forms designated by the Department, which satisfy the following conditions: (1) The recipient’s required level of care has changed, and the following conditions are met: (a) The Department or its designee has determined that the recipient’s level of care is provided by an Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID); (b) The provider has implemented a predischarge planning program and initiated placement activities for the recipient at the earliest appropriate time; (c) The provider has actively pursued placement of the recipient at the required level of care in an appropriate facility during the entire period of administrative days; (d) The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §D(1)(a)—(c) of this regulation for the entire period of the administrative stay claimed for reimbursement; and (e) The recipient is transferred promptly to the first available appropriate facility licensed and certified for the required level of care; (2) When institutional care is no longer appropriate, and the following conditions are met: (a) The Department or its designee has determined that the recipient no longer requires the level of care, which is provided by a nursing facility or Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID); (b) The provider has implemented a predischarge planning program and initiated placement activities for the recipient at the earliest appropriate time; (c) The provider has actively pursued placement of the recipient at the required level of care at home or in an appropriate setting during the entire period of administrative days; (d) The provider has submitted documentation to the Department or its designee that it has complied with the requirements of §D(2)(a)—(c) of this regulation for the entire period of the administrative stay claimed for reimbursement; and (e) The recipient is transferred promptly after appropriate placement has been found; and (3) When the recipient is at an inappropriate level of care but cannot be moved, and the following conditions are met: (a) The attending physician has declared that, because of physical or emotional problems, the recipient is unable to be moved; (b) The reason the recipient cannot be moved is adequately documented by the attending physician in the recipient's record; and (c) Reevaluation by the attending physician of the recipient's inability to be moved and appropriate documentation of it in the recipient's record have been made at least every 60 days. E. Bed Occupancy. The Statewide average occupancy, defined in Regulation .09B(4) of this chapter, shall be calculated after the exclusion of all providers which operated under a waiver of the occupancy standard during any part of the cost report period. F. A waiver of the occupancy standards defined in Regulation .09B(4) of this chapter may be made by the Department under the following conditions: (1) During a period not to exceed the first 12 months of operation for a newly constructed facility or for a newly constructed portion of an existing facility; (2) During periods throughout which the occupancy standard could not be attained due to labor strike, fire, flood, or act of God, when this event is reported to the State licensing authority within 10 days of the event and request for waiver is submitted to the Program within 30 days of the event; (3) For a period not to exceed 12 months when a voluntary reduction in licensed nursing facility bed capacity has been granted by the Department and the provider has received prior approval from the Program to reduce available beds while renovations are being completed; (4) For a period not to exceed 12 months after a new provider acquires an existing facility which has been operated by the previous provider below the occupancy standard due to a ban on admissions, and when prior approval for the waiver has been granted by the Program; (5) For a period not to exceed 12 months after a new provider acquires an existing facility which was in bankruptcy and operated below the occupancy standard at the time of purchase; or (6) For a period not to exceed 12 months after a new provider has acquired or leased a building that was not licensed as a nursing facility immediately before the provider's acquisition or lease. G. When a waiver is granted under the provisions of §F(3) of this regulation, the occupancy standards shall be applied to the reduced licensed capacity. H. A waiver of the occupancy standards defined in Regulation .09B(4) of this chapter may not be allowed due to a ban on admissions or under any circumstances other than those described in §F of this regulation. I. Rates that are determined in accordance with the provisions of §F of this regulation are effective only for the period during which the waiver of the occupancy standard is in effect. #### Regulation .27 Selected Costs — Not Allowable. *COMAR 10.09.10.27* The following costs are not allowable in establishing prospective rates: A. Costs not adequately documented; B. Costs for chaplaincy training and other religious training programs; C. Bad debts incurred by private pay or Medicare patients or third-party payers and bad debts resulting from denied costs of the Program; D. Recipient resources certified as available for medical and remedial care by the Department of Human Services which are uncollected; E. Advertising expenses, except those necessary for personnel recruitment; F. Stockholder costs incurred primarily for the benefit of stockholders or other investors, including the costs of stockholders' annual reports and newsletters, annual meetings, mailing of proxies, stock transfer agent fees, stock exchange registration fees, stockbroker and investment analysis, stock issuance costs, and accounting and legal fees for consolidating statements for Securities and Exchange Commission purposes; G. Any contributions, whether charitable or not, to any individual or organization; H. Public relations expenses; I. Costs of maintaining a recipient in a private room which exceeds costs of a semiprivate room; J. Cost of depreciable assets and minor equipment useful for a lifetime of at least 2 years, with a historical cost of at least $500 or an aggregate historical cost of at least $500 if they are purchased in a quantity of like or similar items; K. Civil money penalties, fines, and all costs associated with sanctions, including receivership, initiated by the Department or any other local, State, or federal government agency; L. Interest paid by a provider under Regulation .23E(5) of this chapter; M. Administrator compensation for any owner, or relative of the owner, in excess of the limits established based on the results of the 2001 nonowner administrator compensation survey, trended forward based on the percentage of the annual increase or decrease in the All Items category of the Consumer Price Index for All Urban Consumers (CPI-U), as follows: (1) For facilities with 1—74 beds, the median compensation from that group; (2) For facilities with 75—199 beds, the median compensation from that group; and (3) For facilities with 200 or more beds, the median compensation from all facilities with 200 or more beds; N. Compensation for any administrator, who is not an owner, or relative of the owner, in excess of the limits established based on the results of the 2001 nonowner administrator compensation survey, trended forward based on the percentage of the annual increase or decrease in the All Items category of the Consumer Price Index for All Urban Consumers (CPI-U), as follows: (1) For facilities with 1—74 beds, the 75th percentile compensation from that group plus 15 percent; (2) For facilities with 75—199 beds, the 75th percentile compensation from that group plus 15 percent; (3) For facilities with 200—299 beds, the 75th percentile compensation from all facilities with 200 or more beds plus 15 percent; and (4) For facilities with 300 or more beds, 15 percent more than the limit established in §N(3) of this regulation for the facilities with 200—299 beds; O. Assistant administrator compensation for any owner, or relative of the owner, in excess of 80 percent of the maximum administrator compensation for the facility established in accordance with §M of this regulation; P. Compensation for any assistant administrator, who is not an owner, or relative of the owner, in excess of 80 percent of the maximum administrator compensation for the facility established in accordance with §N of this regulation; Q. Central office employee compensation for any owner or relative of the owner in excess of the amount established in accordance with §M of this regulation, for the bed size category determined as the sum of beds if multiple facilities, plus 10 percent; R. Compensation for any central office employee, who is not an owner, or relative of the owner, in excess of the amount established in accordance with §N of this regulation, for the bed size category determined as the sum of beds if multiple facilities, plus 10 percent; S. Costs incurred in any effort to acquire a Certificate of Need or an exemption from a Certificate of Need for nursing home beds; T. Costs incurred for specialized support surfaces used for pressure ulcer care; U. Legal, accounting, and other professional expenses related to an appeal challenging a payment determination pursuant to Regulations .23E and .34 of this chapter unless a final adjudication is issued sustaining the nursing facility's appeal; V. A percentage of the legal, accounting, and other professional expenses related to an appeal as described in §U of this regulation, based upon the proportion of additional reimbursement denied to the total additional reimbursement sought on appeal, if a facility prevails on some but not all issues raised in the appeal or action; W. Any charges assessed by the Department for recovery of overpayments; and X. Direct service costs for physical, occupational, and speech therapy. #### Regulation .28 Recipient's Resource. *COMAR 10.09.10.28* A. The Department of Human Services will determine the application of a recipient's resource to the cost of medical or remedial care pursuant to COMAR 10.09.24. B. The provider shall collect a recipient's resource available for medical or remedial care, as certified by the Department of Human Services. C. The total of a recipient's available resource for medical or remedial care and the Department's payment may not exceed the provider's per diem rate. D. The provider shall show sums collected from a recipient's available resource as patient revenue. #### Regulation .29 Recipient's Personal Needs Fund. *COMAR 10.09.10.29* A. If a provider administers a recipient's personal needs fund, it shall administer the fund according to guidelines established by the Department. B. Upon request during normal business hours, a provider shall make available for verification by the Department or its designee the records of all transactions involving recipient's personal needs funds. C. A provider may not use a recipient's personal needs fund for care or services which are either allowable as part of the per diem cost or otherwise covered by the Medical Assistance Program. D. Upon request during normal business hours, 7 days a week, for a minimum of 3 hours each day, a provider shall allow a recipient to withdraw or otherwise use his personal needs fund. E. A provider may not use a recipient's personal needs fund for care or services not requested or not provided. A recipient's personal needs fund may not be used to retire a pre-existing debt. #### Regulation .30 Reimbursement Classes. *COMAR 10.09.10.30* A. The reimbursement classes for the Administrative and Routine cost center are as follows: (1) Facilities in the Baltimore metropolitan region consisting of the following counties: (a) Anne Arundel; (b) Baltimore; (c) Carroll; (d) Harford; and (e) Howard; (1-1) Facilities in Baltimore City; (2) Facilities in the Washington region consisting of the following counties: (a) Charles; (b) Montgomery; and (c) Prince George's; (3) Facilities in the nonmetropolitan region consisting of the following counties: (a) Allegany; (b) Calvert; (c) Caroline; (d) Cecil; (e) Dorchester; (f) Frederick; (g) Garrett; (h) Kent; (i) Queen Anne's; (j) St. Mary's; (k) Somerset; (l) Talbot; (m) Washington; (n) Wicomico; and (o) Worcester. B. The reimbursement classes for the Other Patient Care cost center are based on the county groupings as specified in §A of this regulation. C. For services provided prior to July 1, 2019, the reimbursement classes for the Nursing Service cost center are as follows: (1) Facilities in the Baltimore region consisting of Baltimore City and Baltimore County; (2) Facilities in the Central Maryland region consisting of the following counties: (a) Anne Arundel; (b) Carroll; and (c) Howard; (3) Facilities in the Washington region consisting of the following counties: (a) Charles; (b) Frederick; (c) Montgomery; and (d) Prince George's; (4) Facilities in the nonmetropolitan region consisting of the following counties: (a) Calvert; (b) Caroline; (c) Cecil; (d) Dorchester; (e) Harford; (f) Kent; (g) Queen Anne's; (h) St. Mary's; (i) Somerset; (j) Talbot; (k) Wicomico; and (l) Worcester; (5) Facilities in the Western Maryland region consisting of the following counties: (a) Allegany; (b) Garrett; and (c) Washington. D. Effective July 1, 2020, the reimbursement classes for the Nursing Service cost center are as follows: (1) Facilities in the Baltimore Metro region consisting of Baltimore City and the following counties: (a) Anne Arundel; (b) Baltimore; (c) Carroll; (d) Cecil; (e) Harford; and (f) Howard; (2) Facilities in the Washington Metro region consisting of the following counties: (a) Calvert; (b) Charles; (c) Frederick; (d) Montgomery; (e) Prince George’s; and (f) St. Mary’s; (3) Facilities in the Eastern region consisting of the following counties: (a) Caroline; (b) Dorchester; (c) Kent; (d) Queen Anne’s; (e) Somerset; (f) Talbot; (g) Wicomico; and (h) Worcester; and (4) Facilities in the Western region consisting of the following counties: (a) Allegany; (b) Garrett; and (c) Washington. E. During the period July 1, 2019 through June 30, 2020, reimbursement for the Nursing Service cost center shall be the sum of 50 percent of the amount calculated in accordance with the reimbursement classes under §C of this regulation and 50 percent of the amount calculated in accordance with the reimbursement classes under §D of this regulation. #### Regulation .31 Nursing Service Personnel and Procedures. *COMAR 10.09.10.31* A. Personnel Types and Category Groupings. B. Minimum Data Set Resource Utilization Groups Hourly Weights. #### Regulation .32 Recovery and Reimbursement. *COMAR 10.09.10.32* A. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the recipient for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. C. If the recipient is eligible for benefits from another payment source and elects to forfeit those benefits, the Program may reduce payment by the value of the benefits forfeited. #### Regulation .33 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.10.33* A. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the Program; (2) Withholding of payment by the Program; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed; (5) Denial of payment for new Medicaid admissions. A-1. Federal Remedies. If the Department determines that a provider is not in substantial compliance with federal requirements for participation in the Program, the Department may impose any of the remedies available under 42 CFR Part 488, Subpart F—Enforcement of Compliance for Long-Term Care Facilities with Deficiencies. The Department shall use the criteria set forth in 42 CFR Part 488, Subpart F, as the basis for imposing these remedies. B. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. C. The Department will give reasonable written notice to the nursing facility, to recipients, recipient's next of kin, and others who may be affected, of its intention to impose sanctions. The written notice will state the effective date and specific reasons for the proposed action, and advise the provider of the right to appeal. D. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. #### Regulation .34 Appeal Procedures. *COMAR 10.09.10.34* A. Except as provided for in §B of this regulation, providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. B. Nursing Home Appeal Board. (1) Appeals regarding rate calculations or cost report adjustments which cannot be resolved administratively go to the Nursing Home Appeal Board. (2) The Appeal Board shall be composed of the following members: (a) A representative of the nursing home industry who is: (i) Knowledgeable in Medicare and Medicaid reimbursement principles; and (ii) Appointed by the Secretary; (b) An individual who: (i) Is employed by the State; (ii) Knowledgeable in Medicare and Medicaid reimbursement principles; (iii) Did not directly participate in the field verification or desk review; and (iv) Is appointed by the Secretary; and (c) A third member selected by the first two members of the Board. (3) When the Board is reviewing an appeal from a provider in which a Board member is employed or in which he has a financial or personal interest, the Secretary shall designate an alternate for that member. (4) If the provider elects to appeal to the Appeal Board and the Appeal Board finds in favor of the provider, the Department shall initiate a claims adjustment settlement for the impacted service dates within 60 days after the notification of the findings. (5) The Department or any provider aggrieved by a reimbursement decision of the Appeal Board may not appeal to the Board of Review but may take a direct judicial appeal. The appeal shall be made as provided for judicial review of final decisions in the Administrative Procedure Act, §10-222, State Government Article, Annotated Code of Maryland. (6) An appeal shall be filed in accordance with COMAR 10.01.09. #### Regulation .35 Interpretive Regulation. *COMAR 10.09.10.35* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 11 — Maryland Children's Health Program **Authority:** Health-General Article, §§2-104(b), 15-101(f), 15-103, 15-105, and 15-301 et seq., Annotated Code of Maryland, Ch. 202, Acts of 2003 **Administrative History:** Effective date: **Administrative History:** Regulations .01—.17 adopted as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); adopted permanently effective November 30, 1998 (25:24 Md. R. 1773) **Administrative History:** Regulations .02—.07 and .09—.13 amended as an emergency provision effective July 1, 2001 (28:14 Md. R. 1319); amended permanently October 29, 2001 (28:21 Md. R. 1856) **Administrative History:** Regulation .01B amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulations .01B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Regulation .02B amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .03B amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulations .03B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Regulation .04I amended effective June 21, 2004 (31:12 Md. R. 911) **Administrative History:** Regulation .06 amended effective October 8, 2007 (34:20 Md. R. 1737) **Administrative History:** Regulation .06A amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .06C amended effective June 21, 2004 (31:12 Md. R. 911) **Administrative History:** Regulation .06I amended effective April 19, 2010 (37:8 Md. R. 614) **Administrative History:** Regulation .07C amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .08A, B amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .09A amended effective June 21, 2004 (31:12 Md. R. 911); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .10A amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulations .10A amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Chapter revised effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .11D adopted effective April 13, 2026 (53:7 Md. R. 328) #### Regulation .01 Purpose and Scope. *COMAR 10.09.11.01* A. This chapter governs the determination of eligibility for the Maryland Children's Health Program with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014. B. Eligibility for the Maryland Children's Health Program may be established for children younger than 19 years old whose family income is equal to or less than 200 percent of the federal poverty level. #### Regulation .02 Definitions. *COMAR 10.09.11.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). (2) Applicant. (a) “Applicant” means an individual whose written application for the Maryland Children's Health Program has been submitted to the local health department or the local department of social services but has not received final action. (b) “Applicant” includes an individual whose application is submitted through a representative. (3) “Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an Insurance Affordability Program to the Department or its designee. (4) “Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. (5) “Authorized Representative” has the meaning stated in COMAR 10.01.04.12. (6) “Child” means an individual younger than 21 years old. (7) “Child recipient” means a child younger than 19 years old who is certified as eligible for the Program. (8) “Children’s Health Insurance Program” means the program for uninsured targeted low-income children established under Title XXI of the Social Security Act. (9) “Department” means the Maryland Department of Health. (10) “Designee” means any entity designated to act on behalf of the Department such as: (a) Baltimore City or a county social services department under the supervision of the Department of Human Services; (b) Baltimore City Health Department and its subgrantees, or a county health department; and (c) The Maryland Health Benefit Exchange. (11) “Determination” means a decision regarding an applicant's eligibility for the Maryland Children's Health Program. (12) “Eligibility worker” means an employee of the local health department, or the local department of social services, responsible for determining the eligibility of applicants and recipients. (13) Emergency Medical Condition. (a) “Emergency medical condition” means a condition manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could reasonably be expected to result in placing the patient's health in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part. (b) “Emergency medical condition” includes labor and delivery. (c) “Emergency medical condition” does not include services related to an organ transplant procedure. (14) “Family members” means those individuals living with the applicant whose income is counted, or would be counted if there were any, as household income under Regulation .07B of this chapter. (15) “Federal poverty level” means the nonfarm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981. (16) “Inpatient services” means services received by a recipient while in a medical institution, birthing center, or clinic for which Medical Assistance is provided. (17) “Institution for mental diseases” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed under COMAR 10.07.04. (18) “Insurance Affordability Program” means a program that is one of the following: (a) The Maryland State Medicaid program; (b) The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; (c) An optional state basic health program established under §1331 of the Affordable Care Act; (d) A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; or (e) A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act. (19) “Living together” means sharing a common household. (20) “Local health department (LHD)” means the Baltimore City Health Department and its subgrantees, or a county health department. (21) “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. (22) “MAGI Exempt Coverage Group” means coverage groups such as Aged, Blind, Disabled; Categorically Needy; and Medically Needy as defined under COMAR 10.09.24.02, whose eligibility is not determined by MAGI. (23) “Maryland Children's Health Program (Program)” means the program established in Health-General Article, §15-301 et seq., Annotated Code of Maryland, to provide comprehensive medical care and other health care services to certain children. (24) “Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program. (25) “Maryland Medicaid Managed Care Program” means the Health Choice Program authorized by: (a) Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland; and (b) A waiver issued by the federal government under §1115 of the Social Security Act. (26) “Medical Assistance (Medicaid)” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible individuals. (27) “Period under consideration” means the specific months which are assessed in order to determine eligibility. (28) Public Institution. (a) “Public institution” includes an: (i) Institution that is the responsibility of a government unit or over which a government unit exercises administrative control; or (ii) An establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. (b) “Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves not more than 16 residents. (29) “Qualified alien” means an individual who: (a) Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA); (b) Has been granted asylum in the United States as a refugee under §208 of the INA; (c) Has been admitted into the United States as a refugee under §207 of the INA; (d) Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year; (e) Has had deportation withheld under §243(h) of the INA; (f) Has been granted conditional entry into the United States under §203(a)(7) of the INA which was in effect before April 1, 1980; (g) Is a documented or undocumented immigrant who has been battered or subjected to extreme cruelty by the individual's U.S. citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the alien, if: (i) The spouse or parent consented to, or acquiesced in, the battery or cruelty; (ii) The immigrant has filed a Violence Against Women Act (VAWA) immigration case or a family-based visa petition with Immigration and Naturalization Service (INS); and (iii) In the opinion of the agency providing benefits, there is a substantial connection between the battery or cruelty and the need for the benefits to be provided; (h) Is a victim of a severe form of trafficking who has been subjected to: (i) Sex trafficking if the act is induced by force, fraud, or coercion, or the individual induced to perform the act is younger than 18 years old; or (ii) Involuntary servitude; (i) Is a member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or (j) Is an American Indian born in Canada to whom §289 of the INA applies. (30) “Recipient” means an individual who is certified as eligible for the Maryland Children's Health Program. (31) “Redetermination” means a determination regarding the continuing eligibility of a recipient. (32) “Spouse” means an individual who has been determined to be the husband or wife of another person under State law and for the purpose of determining eligibility for Social Security benefits. (33) “Title XIX” means the title of the Social Security Act, 42 U.S.C. §1396 et seq., which governs establishment of a medical assistance program for low income individuals. (34) “Title XXI” means the title of the Social Security Act through which funding is provided, in part, for the Maryland Children's Health Program. #### Regulation .03 Coverage Groups. *COMAR 10.09.11.03* Eligibility may be established for the Maryland Children's Health Program for children younger than 19 years old whose household income is equal to or less than 200 percent of the federal poverty level. #### Regulation .04 Application. *COMAR 10.09.11.04* A. The Department or its designee shall determine eligibility for children. B. The Department or its designee shall give oral, written, or electronic information about the Maryland Children’s Health Program such as: (1) Requirements for eligibility; (2) Available services; (3) An individual's rights and responsibilities; (4) Information in plain English, supported by translation services; and (5) Information accessible to disabled individuals requesting an application. C. An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply. D. The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means, and in a manner accessible to disabled individuals requesting an application. E. A resident temporarily absent from the State but intending to return may apply for health coverage from an Insurance Affordability Program by telephone, mail, in-person, internet, and other available electronic means to the Department or its designee in any jurisdiction. The individual shall: (1) Demonstrate continued residency in the State; and (2) Meet all nonfinancial and financial requirements in order to be determined eligible. F. Application Filing and Signature Requirements. (1) An individual who wishes to apply for health coverage under an Insurance Affordability Program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice. (2) For the purpose of establishing eligibility of a child applicant who is neither pregnant nor postpartum, a parent or stepparent living with the child shall complete and sign the written, telephonic, or electronic application. If the child does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application. G. The date of application shall be the date on which a written, telephonic, or electronic, signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee. H. An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §I of this regulation. I. Period Under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established under §G of this regulation. For a child, the period under consideration is the 12-month period beginning with the month of application. J. Processing Applications — Time Limitations. (1) When a written, telephonic or electronic application is filed, a decision shall be made promptly but not later than: (a) 10 days from the date of application when filed at the local health department; or (b) 30 days from the date of application when filed at the Department or its designee, but not the local health department. (2) The time standards specified in §J(1) of this regulation cover the period from the date of application to the date the Department or its designee sends a written or electronic notice of its decision to the applicant. (3) The Department or its designee shall inform the applicant by written or electronic notice of the missing information needed to determine eligibility, and the applicable time limit of 10 or 30 days. (4) When an applicant fails to complete the application or to provide the required information needed to determine eligibility within the 10 or 30 day limit provided under §J(1)of this regulation, the applicant shall be determined ineligible. (5) If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, a new period under consideration shall be established based on the date the new application is filed. K. Required Information. All information needed to determine eligibility for the Maryland Children's Health Program shall be reported. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. #### Regulation .05 Application: Additional Requirements. *COMAR 10.09.11.05* A. Social Security Number. (1) As a condition of eligibility, an applicant shall furnish to the Department or its designee a Social Security number for the applicant. If the applicant cannot furnish a Social Security number, the applicant shall apply for a number. Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant complies with this subsection. (2) Eligibility may not be established until the applicant: (a) Furnishes a Social Security number; or (b) Requests the assignment of the number through the Social Security Administration. (3) Failure to provide the required Social Security number shall result in ineligibility for the applicant. (4) If an applicant lacks the resources to meet the requirements of this regulation, the Department or its designee services shall assist the applicant in obtaining the necessary documents, and any costs incurred shall be paid for out of administrative funds. (5) If the application indicates that a Social Security number was issued previously, the Department or its designee shall request validation of the number by the Social Security Administration. (6) Individuals described under COMAR 10.09.24.05D(4)(b) who are applying for limited benefits to treat an emergency medical condition are not subject to the requirements in §A(1)—(4) of this regulation. B. Third-Party Liability. (1) A recipient shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for the recipient's medical expenses. (2) A recipient shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. (3) In accident situations, a recipient shall notify the Department or its designee of the: (a) Time, date, and location of the accident; (b) Name and address of the attorney; (c) Names and addresses of all parties and witnesses to the accident; and (d) Police report number if an investigation is made. C. The Department or its designee shall: (1) Maintain a written or electronic record including documentation of any required elements of eligibility; and (2) Restrict disclosure of information concerning a recipient to purposes directly connected with the administration of the Medical Assistance Program, including: (a) Establishing eligibility; (b) Determining the extent of coverage under Medical Assistance; (c) Providing services for recipients; and (d) Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Medical Assistance Program. D. An applicant or recipient shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic or electronic application. #### Regulation .06 Nonfinancial Eligibility Requirements. *COMAR 10.09.11.06* A. Citizenship. In order to be eligible for full benefits under the Maryland Children's Health Program, an individual shall meet the federal requirements for Medical Assistance eligibility as a citizen or qualified alien, as specified at COMAR 10.09.24.05. B. Residency. In order to be eligible for benefits under this chapter, an individual shall be a resident of Maryland, in accordance with the requirements at COMAR 10.09.24.05-3. C. Age. In order to be eligible for benefits under this chapter, a child shall be younger than 19 years old. D. Inmate of a Public Institution. In order to receive benefits under this chapter, an individual may not be an inmate of a public institution, as specified at COMAR 10.09.24.05-5B. E. Institution for Mental Diseases. In order to be eligible for benefits under this chapter, an individual between 21 and 64 years old or a child applying under Title XXI of the Social Security Act may not be a patient in an institution for mental diseases, unless such individuals are eligible in accordance with COMAR 10.09.24.05-5C. F. No Private Health Insurance. In order to be eligible for benefits under Title XXI of the Social Security Act, an individual whose income is equal to 133 percent but less than 200 percent of the Federal Poverty Level, may not be covered by an employer-sponsored health benefit plan. G. An alien who fails to meet the requirements under §A of this regulation, but meets all other nonfinancial and financial factors of eligibility under this chapter, may be determined eligible for coverage under COMAR 10.09.24.05-2. H. Documentation of Citizenship and Identity. (1) An applicant may not be determined eligible for Maryland Children’s Health Program until the requirements of this regulation are met. (2) An applicant or recipient shall be required as a condition of eligibility to provide documentary evidence of identity as well as citizenship or nationality, to the Department's satisfaction, based on federal requirements, if the individual is: (a) Declared to be a citizen or national of the United States; and (b) Being determined for: (i) Initial eligibility based on an application filed on or after September 1, 2006; or (ii) Continuing eligibility based on a redetermination with an end date on or after September 30, 2006. (3) An applicant may be determined eligible for Maryland Children’s Health Program for a period of 90 days to provide requested documents. When an applicant fails to provide documentation of citizenship within the 90 day period, the applicant shall be determined ineligible. (4) If an applicant or recipient fails to meet the requirements of §H of this regulation within the time standards specified in Regulation .04J(1) of this chapter, and the time standards are not extended, the Department shall: (a) Deny eligibility for an applicant; or (b) Terminate eligibility for a recipient, in accordance with the requirements for timely notice in COMAR 10.01.04. (5) The requirements at §H of this regulation shall be met for all Medical Assistance coverage groups except for: (a) Supplemental Security Income beneficiaries; (b) Newborns who are deemed eligible, for a period of 1 year, for Medical Assistance based on the mother's Medical Assistance eligibility for the newborn's date of birth; (c) Newborns deemed eligible who are born to an otherwise eligible non-qualified alien woman meeting the requirements of under COMAR 10.09.24.05-2 who has filed an application and has been determined eligible for Medical Assistance for the newborn's date of birth; (d) Individuals who are entitled to Medicare benefits or enrolled in any part of Medicare; (e) Individuals receiving SSDI disability insurance benefits under §223 of the Social Security Act, or monthly benefits under §202 of the Social Security Act, based on the individual's disability; (f) Children who are receiving foster care or adoption assistance under Title IV-B or Title IV-E of the Social Security Act; and (g) Other categories of individuals who are considered by the federal government to have previously presented satisfactory documentary evidence of identity as well as citizenship or nationality. (6) Continuing eligibility for a recipient may not be approved at redetermination until the requirements of §H of this regulation are met. (7) If there is documentation in an applicant's or recipient's written or electronic record or a federal or state's database that demonstrates that the individual meets the requirements of §H of this regulation, the individual shall be considered to meet the requirements of §H of this regulation, unless the: (a) Department has cause to question the documentation previously accepted; or (b) Federal government requires additional documentation. #### Regulation .07 Consideration of Household Income. *COMAR 10.09.11.07* A. The applicant shall report the income of any family member, except for the income of a member that does not file a federal tax return and is not claimed as a federal tax dependent. B. Determining Countable Household Income. (1) In determining an applicant's financial eligibility for the Maryland Children's Health Program, the applicant's current household income is considered. (2) For the child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the child applicant and the following family members when living with the child applicant: (a) The child applicant's parents; and (b) At the option of the child applicant's parents, any of the child applicant's siblings. (3) For the married child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the married child applicant and the married child applicant's spouse. C. When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application. D. Treatment of Income. (1) Countable gross income for the Maryland Children’s Health Program shall be the household income calculated according to MAGI. (2) MAGI income limits shall be: (a) Converted from traditional income limits to account for elimination of income disregards. (b) Increased by 5 percentage points of the federal poverty level for the following circumstances: (i) When an individual’s income exceeds the Medicaid income standard; and (ii) The income standard is the highest income standard under which the individual can be determined eligible. (3) Household Composition. For purposes of determining the income standard applicable to an applicant or recipient, the following rules apply. (a) An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made. (b) For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: (i) Spouse; and (ii) Natural, adopted or step children. (c) In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals: (i) Natural, adopted, or step parents; and (ii) Natural, adopted, or step siblings. (d) In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made. (4) No resources or assets test may be applied to an applicant or recipient who is subject to a MAGI-based income test. #### Regulation .08 Consideration of Family Income: Earned and Unearned Income — Repealed. *COMAR 10.09.11.08* #### Regulation .09 Consideration of Family Income: Income Disregards — Repealed. *COMAR 10.09.11.09* #### Regulation .10 Determining Financial Eligibility. *COMAR 10.09.11.10* An applicant is financially eligible for the Maryland Children's Health Program if, for the period under consideration, the applicant's countable household income as determined under Regulation .07 of this chapter does not exceed 200 percent of the federal poverty level for a family size equal to the size of the family for child applicants younger than 19 years old. #### Regulation .11 Certification Periods. *COMAR 10.09.11.11* A. For a newborn, certification begins on the day the child is born to an eligible woman and ends on the last day of the month of the child's 1st birthday. B. For an eligible child, certification begins on the first day of the month of application, or up to 3 months before the month of application, if medical expenses were incurred during the earlier months, and continues until the day the child is determined ineligible. C. A child who, on the day the child becomes 19 years old, is receiving acute inpatient services under this chapter and who, but for attaining that age, would remain eligible for Medical Assistance benefits, shall continue to receive benefits until the end of the stay for which acute inpatient services are furnished. D. Individuals may be certified for a period of continuous eligibility as described in COMAR 10.09.24.12. #### Regulation .12 Covered Services. *COMAR 10.09.11.12* A. A child certified for the Program is entitled to all health benefits through the Maryland Medicaid Managed Care Program. B. In the case of an alien who is eligible for benefits under COMAR 10.09.24.05D(4)(b), covered services are limited to those that are necessary for the treatment of an emergency medical condition, as defined under Regulation .02B of this chapter. #### Regulation .13 Post-Eligibility Requirements. *COMAR 10.09.11.13* A. Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following: (1) For eligible individuals: (a) The basis and effective date for eligibility; (b) Instructions for reporting changes that may affect the recipients eligibility; and (c) The right to request a hearing; (2) For ineligible individuals: (a) A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; (b) Information regarding application for MAGI Exempt coverage groups; and (c) The right to request a hearing. B. Recipient Responsibility. After an individual has been determined to be eligible for MCHP and is enrolled in MCHP: (1) The Department shall periodically redetermine the recipient's eligibility for MCHP as specified under §D; and (2) The recipient or the recipient's representative shall, within 10 days of the occurrence, notify the Department if there is a change in the recipient's, the recipient's parent's, or the recipient's guardian's: (a) Income; (b) Employment; (c) Address; or (d) Health insurance coverage status. (3) A recipient or the recipient's representative shall limit use of the Medical Assistance card to the individual whose name appears on the card. (4) When written or electronic notice of cancellation is received, a recipient shall discontinue use of the Medical Assistance card on the first day of ineligibility and return the card to the Department. (5) Failure to comply with the provisions of §B(1)—(3) of this regulation may result in: (a) The termination of assistance; or (b) Referral to the Department for fraud investigation, or for criminal or civil prosecution. (6) A recipient shall cooperate with the Department’s quality control and audit review process, including verification of all information pertinent to the determination of eligibility. (7) If the recipient refuses to cooperate, the recipient's coverage shall be terminated subject to the regulation governing timely and adequate notice under COMAR 10.01.04. C. Unscheduled Redetermination. (1) The Department or its designee shall: (a) Promptly make an unscheduled redetermination of a child recipient's eligibility when changes in circumstances or relevant facts are: (i) Reported by someone on the recipient's behalf, or (ii) Brought to the attention of the Department or its designee from other responsible sources; (b) Notify the recipient that redetermination is required to establish continuing eligibility; and (c) Notify the recipient of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. (2) Eligibility Decisions. Recipients who are determined: (a) Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or (b) Ineligible because of a change in circumstances or failure to establish eligibility following a change in circumstance shall be sent notice in accordance with §A(2) of this regulation. (3) A recipient whose eligibility has been canceled may reapply at any time after the cancellation of eligibility and a new period under consideration shall be established. D. Scheduled Redetermination. Except for children eligible as newborns of eligible women, the Department or its designee shall make a scheduled redetermination of a child recipient's eligibility at least every 12 months. #### Regulation .14 Hearings. *COMAR 10.09.11.14* The requirements relating to hearings under COMAR 10.01.04 apply to this chapter. #### Regulation .15 Fraud and Abuse. *COMAR 10.09.11.15* The requirements relating to fraud and abuse under COMAR 10.09.24.14 apply to this chapter. #### Regulation .16 Adjustments and Recoveries. *COMAR 10.09.11.16* The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, with the exception of COMAR 10.09.24.15A(1) and (2), apply to this chapter. #### Regulation .17 Interpretive Regulation. *COMAR 10.09.11.17* State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation. ### Chapter 12 — Disposable Medical Supplies and Durable Medical Equipment **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1976 (2:29 Md. R. 1740) **Administrative History:** Regulation .04A amended effective February 8, 1980 (7:3 Md. R. 264) **Administrative History:** Regulation .05 amended effective February 8, 1980 (7:3 Md. R. 264) and April 4, 1980 (7:7 Md. R. 708) **Administrative History:** Chapter revised effective June 26, 1981 (8:13 Md. R. 1139) **Administrative History:** Regulation .01B amended effective July 11, 1988 (15:13 Md. R. 1553) **Administrative History:** Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572); May 29, 1989 (16:10 Md. R. 1108) **Administrative History:** Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .04A amended effective July 1, 1987 (14:13 Md. R. 1473); May 29, 1989 (16:10 Md. R. 1108) **Administrative History:** Regulation .04B amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); May 29, 1989 (16:10 Md. R. 1108) **Administrative History:** Regulation .04E amended effective July 2, 1984 (11:13 Md. R. 1176); August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .04F G adopted effective June 2, 1986 (13:11 Md. R. 1273) **Administrative History:** Regulation .04H adopted effective March 23, 1987 (14:6 Md. R. 715) **Administrative History:** Regulation .05 amended effective July 2, 1984 (11:13 Md. R. 1176); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655); May 29, 1989 (16:10 Md. R. 1108) **Administrative History:** Regulation .05A-3 and A-4 adopted, B amended effective July 1, 1987 (14:13 Md. R. 1473) **Administrative History:** Regulation .05B and D amended effective June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715) **Administrative History:** Regulation .06 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273); **Administrative History:** Regulation .06A amended effective March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); May 30, 1988 (15:11 Md. R. 1331); July 11, 1988 (15:13 Md. R. 1553) **Administrative History:** Regulation .06D amended effective May 30, 1988 (15:11 Md. R. 1331) **Administrative History:** Regulation .06D-1 amended effective August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .07 amended effective July 2, 1984 (11:13 Md. R. 1176); October 29, 1984 (11:21 Md. R. 1812); June 2, 1986 (13:11 Md. R. 1273); May 29, 1989 (16:10 Md. R. 1108) **Administrative History:** Regulation .07 amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2392); amended permanently effective February 9, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .07B-1 adopted effective August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .07C-1 repealed effective August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .07C-1 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715) **Administrative History:** Regulation .07C-2 adopted effective July 1, 1987 (14:13 Md. R. 1473) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .07D amended effective October 1, 1983 (10:19 Md. R. 1691); June 2, 1986 (13:11 Md. R. 1273); March 23, 1987 (14:6 Md. R. 715); July 1, 1987 (14:13 Md. R. 1473); July 1, 1988 (15:13 Md. R. 1554); July 11, 1988 (15:13 Md. R. 1553); July 25, 1988 (15:14 Md. R. 1655) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 **Administrative History:** Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .07D, F-1 adopted effective August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625); June 2, 1986 (13:11 Md. R. 1273) **Administrative History:** Regulation .07F-2 adopted effective June 2, 1986 (13:11 Md. R. 1273); amended effective March 23, 1987 (14:6 Md. R. 715) **Administrative History:** Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07Q amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)) **Administrative History:** Regulation .07Q amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2105) **Administrative History:** Chapter revised effective March 16, 1992 (19:5 Md. R. 577) **Administrative History:** Chapter revised effective November 16, 1998 (25:23 Md. R. 1696) **Administrative History:** Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 30, 2012 (39:8 Md. R. 533); June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568); January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .03G amended effective September 11, 2006 (33:18 Md. R. 1505) **Administrative History:** Regulation .04 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); January 1, 2018 (44:26 Md. R. 1214); June 14, 2021 (48:12 Md. R. 470); June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .04E amended effective April 30, 2012 (39:8 Md. R. 533) **Administrative History:** Regulation .05 amended effective August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .05A amended effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .05D amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .05K amended effective June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .05L adopted effective June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation05M-Q amended effective June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .06 amended effective January 7, 2002 (28:26 Md. R. 2272); August 1, 2005 (32:15 Md. R. 1320); October 16, 2023 (50:20 Md. R. 887) **Administrative History:** Regulation .06A amended effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .06A,B amended effective June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .06D amended effective June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .06E amended effective September 29, 2003 (30:19 Md. R. 1331); June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .07 amended effective September 29, 2003 (30:19 Md. R. 1331); August 1, 2005 (32:15 Md. R. 1320); September 11, 2006 (33:18 Md. R. 1505); April 19, 2010 (37:8 Md. R. 615); April 30, 2012 (39:8 Md. R. 534); July 4, 2016 (43:13 Md. R. 712); October 16, 2023 (50:20 Md. R. 887) **Administrative History:** Regulation .07D amended effective February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .07F amended effective February 9, 2009 (36:3 Md. R. 208); February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .07F-1 adopted effective June 14, 2021 (48:12 Md. R. 470) **Administrative History:** Regulation .07Z adopted effective January 1, 2018 (44:26 Md. R. 1214) #### Regulation .01 Definitions. *COMAR 10.09.12.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific supply or piece of equipment, excluding token charges for charity patients and substandard charges for welfare and other low income patients. (2) “Customized equipment” means durable medical equipment which is uniquely constructed or substantially modified by the provider from the standard product: (a) For a specific recipient according to the description and orders of a physician; and (b) In such a way that the equipment can only be used by the specific recipient. (3) “Department” means Maryland Department of Health as defined in COMAR 10.09.36.01. (4) “Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medically necessary purpose and, with the exception of disposable gloves and incontinence supplies, have no practical use in the absence of illness, injury, disability, or health condition. (5) “Durable medical equipment” means equipment which satisfies all of the following requirements: (a) It can withstand repeated use; (b) It is used to serve a medically necessary purpose; and (c) It has no practical use in the absence of illness, injury, disability, or health condition. (6) “Home” means that place of residence occupied by the recipient, including an assisted living facility, but other than a hospital, nursing facility, or other medical institution. (7) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. (8) “Incontinence” means the inability to refrain from yielding to the urge to urinate or defecate for persons previously having bowel or bladder control or individuals who are lacking bowel or bladder control due to congenital anomalies or postnatal insult. (9) “Invoice” means a form designated by the Department for use by providers in submitting bills for payment. (10) “Maximum allowable reimbursement” means the payment limitation established by the Department. (11) “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (12) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (13) “Medicare” means Medicare as defined in COMAR 10.09.36.01. (14) “Nursing facility” means a facility licensed as a comprehensive care or extended care facility pursuant to COMAR 10.07.02. (15) “Orthotic device” means rigid and semi-rigid devices used for the purpose of supporting a weak or misaligned body member or restricting or eliminating motion in a diseased or injured part of the body. (16) “Physical therapy program” means an established program that outlines the prescribed equipment and treatment, along with frequency, duration, and goals or expected outcome of the recipient. (17) “Prepayment authorization” means the approval required from the Department or its designee before services can be reimbursed. (18) “Prescriber” means a physician, dentist, podiatrist, physician’s assistant, clinical nurse specialist, or nurse practitioner licensed in the state in which the prescriber's practice is maintained who has examined the recipient. (19) “Prescriber order” means a document on the prescriber's letterhead or prescription form which details the: (a) Patient name and Medical Assistance number; (b) Item needed including the accessories, adaptions, modifications, and attachments considered medically necessary and medically appropriate by the prescriber; (c) Estimated quantity of the item; (d) Length of time of need; (e) Date of face-to-face encounter and how the health status of the recipient at the time of the face-to-face encounter is related to the items prescribed; and (f) Prescriber’s signature. (20) “Prescription” means a written order for medical supplies or equipment, signed by the prescriber. (21) “Program” means program as defined in COMAR 10.09.36.01. (22) “Prosthetic device” means: (1) An artificial device to replace, in whole or in part, a leg, arm, or eye; or (2) An artificial breast, including surgical brassiere. (23) “Provider” means provider as defined in COMAR 10.09.36.01. (24) “Recipient” means recipient as defined in COMAR 10.09.36.01. (25) Wholesale cost. (a) “Wholesale cost” means the price paid by the provider to the manufacturer or any other supplier for disposable medical supplies or durable medical equipment after consideration of both primary discounts and secondary volume and prompt payment discounts applicable at the time the manufacturer's invoice is paid. (b) “Wholesale cost” includes, but is not limited to: (i) Shipping; (ii) Handling; and (iii) Insurance costs. (c) “Wholesale cost” does not include associated costs such as: (i) Evaluation; (ii) Assembly by the provider; (iii) Fitting and adjustment; and (iv) Delivery to the recipient. #### Regulation .02 License Requirements. *COMAR 10.09.12.02* Providers of services shall meet the licensing requirements as set forth in COMAR 10.09.36.02. #### Regulation .03 Conditions for Participation. *COMAR 10.09.12.03* To participate in the Program, the provider: A. Effective January 1, 2018, shall be in an approved status with Medicare; B. Effective April 1, 2012 through December 31, 2017, shall, unless exempt from Medicare accreditation requirements: (1) Be accredited by a Medicare-approved accreditation organization; (2) Provide documentation of: (a) Accreditation; or (b) Having submitted an application for accreditation; and (3) Be accredited or terminated from the Program; C. Shall meet the conditions for participation as set forth in COMAR 10.09.36.03; D. Shall be prepared to furnish necessary service and repairs to equipment dispensed by the provider; E. Shall certify residential service agency status as set forth in COMAR 10.07.05 by submitting either a: (1) Copy of the license; or (2) Form supplied by the Department which documents exempt status; F. May not charge the recipient any fee or deposit; G. Shall collect and report as a collection any and all possible rebates or other third-party reimbursement; H. Shall mark durable medical equipment with an identification tag as specified and provided by the Program, noting the tag number on all appropriate delivery tickets; and I. Shall participate in the Program's recycling efforts as set forth in Regulation .07O of this chapter. #### Regulation .04 Covered Services. *COMAR 10.09.12.04* A. The following medically necessary items are covered when ordered by an individual who is enrolled as a provider in the Program on the date of service: (1) Disposable medical supplies; (2) Durable medical equipment; (3) Repairs to purchased durable medical equipment; (4) All disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients; (5) Orthotic devices; (6) Repair of orthotic devices; (7) Replacement of orthotic devices; (8) Prosthetic devices which include: (a) Artificial eyes; (b) Breast prostheses, including surgical brassiere; (c) Upper and lower extremity, full and partial, to include stump cover or harnesses where necessary; and (d) Custom-designed, fabricated, fitted, or modified devices to treat partial or total limb loss for purposes of restoring physiological function; (9) Repair of prosthetic devices; (10) Replacement of prosthetic devices; (11) Individually form-fitted support stockings, leg or arm, including all fitting, dispensing, and follow-up care, for recipients for whom these supports are medically necessary, not to exceed two at one time, three times in a 12-month period for recipients 21 years old or older; (12) Evaluation for equipment that was subsequently provided through the Department's recycling program as described in Regulation .07O of this chapter; (13) Speech generating, augmentative, and alternative communication devices for recipients enrolled under fee-for-service or a Managed Care Organization; and (14) Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home. B. The items in §A of this regulation are covered when medically necessary for use in the recipient's: (1) Home; (2) School; or (3) Place of employment. C. The items in §A(8)—(10) of this regulation are covered once annually when medically necessary for the purpose of performing physical activities including running, biking, swimming, strength training and other activities to maximize overall health. D. Repairs under §A(3) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions for equipment that was purchased for the recipient while the recipient lived in the community. E. Items in §A(8)—(10) of this regulation are also covered for recipients in hospitals, nursing facilities, and other medical institutions. F. Replacements under §A(10) are covered: (1) Once annually for devices less than 3 years old if the replacement is for the following reasons: (a) A change in the physiological condition of the patient; (b) Unless necessitated by misuse, because of an irreparable change in the condition of the prosthetic device or the component of the prosthetic device; or (c) Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device; and (2) For devices more than 3 years old subject to §§B and C of this regulation. G. Documentation Required. (1) Items in §A of this regulation are covered only when adequate documentation is obtained by the provider and kept on file as part of the permanent business records of the provider. This documentation includes, but is not limited to the: (a) Signed and dated prescriber order including documentation that a face-to-face encounter occurred within 6 months before ordering services; (b) Recertifications of continuous medical need; (c) Delivery ticket signed by the recipient or the recipient's representative where the identification of the person signing and the exact nature of the items delivered is clearly evident on the delivery ticket; (d) Make, model, and serial number of the item, as applicable; and (e) Cost of the item to the provider for individually considered items reimbursed under a cost-plus methodology. (2) For purchased equipment, the delivery ticket shall note the identification tag number and also include a statement which notifies the recipient that the equipment has been purchased by the State of Maryland and remains the property of the Department of Health. (3) Documentation shall be retained for 6 years and be made available upon request by the Department. H. The Department may arrange for the provision of any covered service listed in §A of this regulation under an exclusive contract with a vendor or vendors that has been awarded in accordance with State regulations and policies governing contracts and procurements. #### Regulation .05 Limitations. *COMAR 10.09.12.05* The Program does not cover: A. Incontinency pants and disposable underpads unless the following conditions are met: (1) The incontinence supplies are medically necessary for medical conditions associated with prolonged urinary or bowel incontinence; (2) For pull-on underwear type garments, the recipient is capable of independently putting on and removing the garment; and (3) Disposable incontinence supplies meet, at a minimum, the following absorbent capacity standards: (a) For children's diapers and underwear, not less than 800cc; (b) For youth diapers and underwear, not less than 1,000cc; (c) For small adult diapers and underwear, not less than 1,200cc; (d) For medium adult diapers and underwear, not less than 1,750cc; (e) For large, extra large, and bariatric adult diapers and underwear, not less than 2,000cc; and (f) For disposable underpads, not less than 1,000 cc; B. Osteogenesis stimulators unless the following criteria are met: (1) The use is for noninvasive therapy; (2) The bone fracture is at least 6 months old, except when used for pseudarthrosis; and (3) The space gap of the fracture measures 1/2 centimeter or less, except when used for pseudarthrosis; C. Osteogenesis stimulators beyond the first 6 weeks of use unless evaluations at the 6-week and 3-month intervals after initial date of service verify recipient use of at least 50 percent of the time prescribed, on a form designated by the Program; D. The following durable medical equipment: (1) Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, emesis basins, posture support chairs, over-the-bed tables; (2) Self-help devices including, but not limited to, grab bars, shower stools, and commode seats; (3) Abdominal supports; (4) Bed boards; (5) Enema bags; (6) Environmental controls; (7) Exercise equipment and devices, unless home use of such equipment is a necessary component of an active physical therapy program; (8) Geriatric chairs; (9) Heating pads or lamps; (10) Hot water bottles; (11) Hydrocollators; (12) Ice bags; (13) Knee cages; (14) Nasal atomizers; (15) Restraints; (16) Sitz baths; (17) Soft collars; (18) Whirlpools; (19) Whirlpool bath equipment; E. Disposable medical supplies and durable medical equipment provided in a facility or by a group when reimbursement is covered by another segment of the Program; F. Items which are investigational or experimental in nature; G. Nutritional supplements supplied by a DMS/DME provider under this chapter if the provider is also a licensed pharmacy and has a Medicaid Pharmacy provider number; H. Food supplements or infant formulas, including enteral nutritional products and supplemental vitamin and mineral products, when administered orally; I. Purchase of used equipment, except as approved by the Department as per Regulation .07L of this chapter; J. Equipment if the recipient owns or otherwise has access to useable equipment that serves the same purpose as the requested equipment; K. Replacement of equipment or a device while the item is still under warranty or before having met the Department’s life expectancy schedule unless prepayment authorization has been obtained. L. Replacement of a prosthetic device or component if necessary due to misuse. M. Rental of any equipment not in good working condition for the entire length of rental; N. Rental of equipment for any period longer than 90 days without renewed documentation of continued medical need from the prescriber for each 90-day period; O. Modifications to motor vehicles; P. Disposable medical supplies and durable medical equipment ordered by an individual who is not enrolled as a provider in the Program on the date of service; and Q. Disposable medical supplies and durable medical equipment ordered by an entity, facility, or other provider that is not an individual. #### Regulation .06 Prepayment Authorization Requirements. *COMAR 10.09.12.06* A. Prepayment authorization is required for: (1) Disposable medical supplies with a charge exceeding $500, except as specified in §B(1) and (4) of this regulation and durable medical equipment on the approved list of items as individual consideration (I/C); (2) All incontinency pants for recipients 3 through 15 years old in excess of 240 in any 30-day period, and disposable underpads for recipients 3 through 15 years old in excess of 135 in any 30-day period; (3) All incontinency pants for recipients 16 years old or older in excess of 180 in any 30-day period, and disposable underpads for recipients 16 years old or older in excess of 100 in any 30-day period; (4) All disposable incontinency pants and all disposable underpads for recipients younger than 3 years old; (5) Disposable medical supplies and durable medical equipment not on the approved list of items; (6) Any rental of durable medical equipment after 3 months of rental; (7) All repairs to purchased durable medical equipment exceeding $500; (8) Durable medical equipment with a purchase price of $1,000 or more except as specified in §B(1) and (4) of this regulation; (9) Prosthetics and orthotics with a charge exceeding $1,000 except as specified in §B(1) and (4) of this regulation; and (10) Medical equipment, supplies not listed on the approved list of items. B. Prepayment authorization is not required for: (1) Any disposable medical supplies and durable medical equipment for home kidney dialysis purchased or rented for Medical Assistance recipients; (2) Prosthetic devices under $1,000; (3) Orthotic equipment under $1,000; and (4) Enteral and parenteral supplies not exceeding one unit per day. C. For the rental of durable medical equipment, the following prepayment authorization requirements apply: (1) For durable medical equipment below $1,000: (a) Months 1 through 3, the rental does not require a prepayment authorization; (b) Months 4 through 10, the rental does require a prepayment authorization; and (c) Month 10 is the final rental month, after which the item is considered purchased. (2) For durable medical equipment above $1,000, and items requiring individual consideration: (a) Months 1 through 10, the rental does require prepayment authorization; and (b) Month 10 is the final rental month, after which the item is considered purchased. D. The prescriber shall submit requests for prepayment authorization, when required, using the format and procedures designated by the Department. E. Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile shall be followed by a request for prepayment authorization, which shall be submitted immediately to the Department. Providers shall call the Program before making a request via facsimile. F. Except as provided in §H of this regulation, providers shall submit prepayment authorization requests to the Program not later than 30 days following the first date of service. G. Prepayment authorization is issued when: (1) Program procedures are met; (2) The prescriber submits to the Department adequate documentation demonstrating that the service to be authorized is medically necessary; and (3) A request for supplies or equipment on the list of approved items, or on the list but without a specified maximum Program price, is accompanied by the manufacturer's suggested retail price or an invoice or other documentation of the wholesale cost, whichever is applicable under Regulation .07 of this chapter. H. Prepayment authorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—G of this regulation. I. The Department is not responsible for any reimbursement to a provider for any service provided which requires prepayment authorization unless the authorization has been granted by the Program. #### Regulation .07 Payment Procedures. *COMAR 10.09.12.07* A. Payment procedures shall be as set forth in COMAR 10.09.36.04. B. The provider’s billed charges to the Program may not exceed the provider’s customary charge. If the item is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with the provisions of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. C. The provider shall give the Program the full advantage of any and all manufacturer's warranty offered on the item. D. Effective July 1, 2022, the Department shall pay providers 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare rate established January 1 of each year for prosthetic devices. For prosthetic devices for which Medicare has not established a rate, the Department shall pay providers the manufacturer’s suggested retail price of the item, less 26.5 percent. The payment shall include all fitting, dispensing, and follow-up care. E. Charges for osteogenesis stimulators shall include all follow-up care, batteries, repairs, and replacement parts within the limitations of Regulation .05E and F, at the following times: (1) Initial date of service; (2) After 6-week evaluation; (3) After 3-month evaluation. F. With the exception of items free to individuals not covered by Medicaid, the Department shall reimburse providers for the purchase of covered services at the lesser of the provider’s customary charge or: (1) For the purchase of items for which Medicare has established a rate: (a) Disposable medical supplies and durable medical equipment other than enteral nutritional products and enteral and parenteral therapy supplies at 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate established January 1 of each year; (b) Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(1) of this regulation; (c) Enteral and parenteral therapy supplies as established in §F-1(2) of this regulation; and (d) For medical equipment for which Medicare has established a rental rate, the purchase price shall be 10 times the lowest rural, non-rural, or competitive bidding area (CBA) Medicare monthly rental rate. (2) For the purchase of items for which Medicare has not established a rate: (a) Disposable medical supplies not otherwise specified in this section are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or the provider’s wholesale cost plus 37.2 percent; (b) Enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home as established in §F-1(3) of this regulation; (c) Enteral and parenteral therapy supplies as established in §F-1(4) of this regulation; (d) Incontinence supplies at the provider's wholesale cost plus 25 percent; (e) Customized equipment at the provider's choice of the manufacturer's suggested retail price minus 30 percent or provider's wholesale cost plus 40 percent; and (f) Durable medical equipment, not otherwise specified in this section, are reimbursed at the provider’s choice of the manufacturer’s suggested retail price minus 41.2 percent or provider’s wholesale cost plus 27.4 percent. F-1. Enteral Nutritional Product and Enteral and Parenteral Supply Reimbursement Rates Effective February 1, 2021. (1) Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit: (2) Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit: (3) Effective February 1, 2021, enteral nutritional products given by nasogastric, jejunostomy, or gastrostomy tube in the home shall be reimbursed at the following rates per unit: (4) Effective February 1, 2021, enteral and parenteral therapy supplies shall be reimbursed at the following rates per unit: G. The Department shall reimburse providers for the monthly rental of covered services as follows: (1) For items for which Medicare has established a purchase rate, 85 percent of the lowest rural, non-rural, or competitive bidding area (CBA) Medicare purchase reimbursement rate divided over 10 months; (2) For items for which Medicare has not established a purchase rate, items will be rented at the provider’s choice of: (a) The manufacturer’s suggested retail price minus 41.2 percent, divided over 10 months; or (b) The provider’s wholesale cost plus 27.4 percent, divided over 10 months; and (3) After 10 months of monthly rental, the item will be considered purchased. H. The Department reserves the right to prorate the monthly rental amount for daily rentals. I. The Department shall pay for repairs to purchased durable medical equipment according to the following: (1) The provider's choice of wholesale cost plus 37.2 percent or the manufacturer's suggested retail price minus 31.4 percent to the provider for all materials; (2) Labor costs shall be billed in quarter hour increments using the appropriate procedure code and shall be reimbursed the lesser of: (a) The supplier’s customary charge unless the service is free to individual not covered by Medicaid; or (b) The reimbursement rate specified in the Medicaid Durable Medical Equipment Program's approved list of items. J. The determination to purchase or rent medical equipment shall be based on the prescriber's best faith estimate of length of time the equipment will be needed by the recipient. When the equipment is ordered for: (1) 10 or more months, the provider shall charge the Program for a purchase, unless: (a) The items cannot be purchased, in which case the items shall continue to be rented for the duration of their need at the amount determined on the fee schedule or elsewhere in this chapter; or (b) There is justification to request a rental rather than a purchase of the item, and a request for prepayment authorization is submitted to and approved by the Program before the submission of the invoice for the item; and (2) Less than 10 months, the provider shall charge the Program for rental of the item for the duration of the medical necessity except that: (a) If the equipment is still medically necessary after 10 months of rental and the equipment is purchasable, the tenth rental payment is the final rental payment, and the equipment is considered purchased by the Program; or (b) If there is justification to request a purchase rather than a rental of the item, a request for prepayment authorization shall be submitted to the Program and approved by the Program before the submission of the invoice. K. Medical equipment that is determined by the Department to require frequent and substantial servicing in order to avoid risk to the recipient's health shall be reimbursed at the rental rate in accordance with §G of this regulation until either the equipment is no longer medically necessary or the recipient is no longer eligible for Medical Assistance fee-for-service benefits. L. Every 90 days during the rental term the provider shall obtain recertification from the prescriber and keep in the provider's records a recertification of continuous medical need that the equipment is still medically necessary. M. The Department shall review purchase prices and rental charges for items for which Medicare has not established a rate at least every 3 years. N. If services are provided under a contract pursuant to Regulation .04F of this chapter, the Department shall reimburse the contracted vendor or vendors at rates and under conditions in accordance with the contract or contracts. O. Once an item has been purchased in full, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered by the Department or its designee. The Department may arrange for the provision of recycled equipment under an exclusive contract with a vendor or vendors that have been awarded in accordance with State regulations and policies governing contracts and procurement. The Department also may determine the geographical scope and the types of equipment, or both, to be included under the contract. The vendor or vendors shall be reimbursed at a rate and under terms established in the contract. P. For equipment that is not covered under a contract awarded under §O of this regulation, the provider that originally furnished the equipment to the recipient shall recover the equipment after it is no longer required by the recipient. After recovery of the equipment, the provider shall determine the viability of recycling the item and, upon its reissue, bill the Program 75 percent of the Program's original payment. Q. To the extent that the Department chooses to use an exclusive contract to provide recycled equipment under §O of this regulation, the Department shall reimburse providers for evaluation of a recipient for equipment that is subsequently provided through the Department's recycling program at 11.5 percent of the reimbursement rate established under §§AH of this regulation. R. The Department will authorize payment on Medicare claims if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that services were medically justified; (4) The services are covered by the Program; (5) Initial billing is made directly to Medicare according to Medicare guidelines. S. Supplemental payments on Medicare claims are made subject to the following provisions: (1) Deductible insurance will be paid in full; (2) Coinsurance will be paid in full; (3) Services not covered by Medicare, but by the Program, will be paid in accordance with the limitations of §I of this regulation. T. The provider may not bill the Department for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail or telephone; or (4) Fitting, dispensing, or follow-up care except as set forth in §D of this regulation. U. The methodology in §§F and G of this regulation shall be used to establish a list of approved items with the corresponding procedure code, maximum allowable reimbursement amount, useful life expectancy, and maximum number allowed. This list shall be made available to the providers for ease of administration of the Program. When the approved list of items contains a price for a procedure code, the Department shall reimburse providers the lesser of the price listed in the approved list or the provider’s customary charge unless the service is free to individuals not covered by Medicaid. V. The provider shall ensure that the equipment is in good working condition both throughout the rental of the equipment and at the end of the rental term. W. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. X. Durable medical equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing medical equipment and supplies. Y. Refills. (1) For durable medical equipment or disposable supplies, or both that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order. (2) The provider shall maintain documentation of contact and confirmation of any changes and modifications of the order for audit purposes. (3) The provider shall contact the recipient or designee regarding refills no earlier than 7 business days before the anticipated delivery date or anticipated shipping date. (4) For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product. Z. The disposable medical supplies or durable medical equipment provider shall identify the individual who ordered the disposable medical supplies and durable medical equipment by recording the individual practitioners National Provider Identifier (NPI) number on the claim. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.12.08* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.12.09* Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.12.10* Appeal procedures shall be as set forth in COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.12.11* State Regulations shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 13 — Ambulance and Wheelchair Van Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1976 (2:29 Md. R. 1740) **Administrative History:** Chapter revised September 23, 1977 (4:20 Md. R. 1545) **Administrative History:** Regulation .01 amended effective January 23, 1989 (16:1 Md. R. 70) **Administrative History:** Regulation .01B and .05I amended, and .05J adopted as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulation .01C-1 adopted and D amended effective July 1, 1986 (13:13 Md. R. 1492) **Administrative History:** Regulation .03B amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113); January 23, 1989 (16:1 Md. R. 70) **Administrative History:** Regulation .04A amended effective July 1, 1986 (13:13 Md. R. 1492) **Administrative History:** Regulation .05 amended effective July 1, 1986 (13:13 Md. R. 1492) **Administrative History:** Regulation .06A amended effective July 1, 1986 (13:13 Md. R. 1492) **Administrative History:** Regulation .06E adopted effective April 4, 1980 (7:7 Md. R. 708) **Administrative History:** Regulation .07 amended effective January 23, 1989 (16:1 Md. R. 70) **Administrative History:** Regulation .07A-1 adopted, E and G amended effective July 1, 1986 (13:13 Md. R. 1492) **Administrative History:** Regulation .07A-1 amended effective February 22, 1988 (15:4 Md. R. 473) **Administrative History:** Regulation .07D amended effective July 1, 1978 (5:12 Md. R. 968); January 1, 1980 (6:26 Md. R. 2075); July 1, 1980 (7:13 Md. R. 1279) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1982 (9:11 Md. R. 1123); adopted permanently effective November 1, 1982 (9:19 Md. R. 1894) **Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .07H amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) **Administrative History:** Regulation .07J amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .07J amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Chapter revised effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .01B amended effective July 18, 1994 (21:14 Md. R. 1229) **Administrative History:** Regulation .03 amended effective July 18, 1994 (21:14 Md. R. 1229) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted effective July 18, 1994 (21:14 Md. R. 1229) **Administrative History:** Regulation .05 amended effective July 18, 1994 (21:14 Md. R. 1229) **Administrative History:** Regulation .06 repealed effective July 18, 1994 (21:14 Md. R. 1229) **Administrative History:** Regulation .07 amended effective July 18, 1994 (21:14 Md. R. 1229) #### Regulation .01 Definitions. *COMAR 10.09.13.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” has the meaning stated in COMAR 10.09.36. (2) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36. (3) “Medical Care Programs” has the meaning stated in COMAR 10.09.36. (4) “Medicare” has the meaning stated in COMAR 10.09.36. (5) “Program” has the meaning stated in COMAR 10.09.36. (6) “Provider” has the meaning stated in COMAR 10.09.36. (7) “Recipient” has the meaning stated in COMAR 10.09.36. #### Regulation .02 Licensing Requirements. *COMAR 10.09.13.02* Providers shall meet all licensing requirements as set forth in COMAR 10.09.36. #### Regulation .03 Conditions for Participation. *COMAR 10.09.13.03* To participate in the Program, the provider shall: A. Comply with the conditions for participation as set forth in COMAR 10.09.36; B. Be approved as a provider of ambulance services by Medicare. #### Regulation .04 Covered Services. *COMAR 10.09.13.04* The program covers copayment and deductible payments for Medicare-approved services to Maryland Medical Assistance recipients. #### Regulation .05 Limitations. *COMAR 10.09.13.05* The Program does not cover any payment for service other than coinsurance and deductible as approved by Medicare. #### Regulation .06 Repealed. *COMAR 10.09.13.06* #### Regulation .07 Payment Procedures. *COMAR 10.09.13.07* A. Payment procedures for this chapter are set forth in COMAR 10.09.36. B. The Department will authorize payment on Medicare ambulance claims if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) The services are covered by the Program; (4) Initial billing is made directly to Medicare according to Medicare guidelines; (5) Medicare has determined that services were medically justified. C. The Department will make supplemental payment on Medicare ambulance claims, subject to the following conditions: (1) Deductible insurance will be paid in full; (2) Coinsurance will be paid in full. D. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.13.08* Recovery and reimbursement for this chapter are set forth in COMAR 10.09.36. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.13.09* Cause for suspension or removal and imposition of sanctions for this chapter are set forth in COMAR 10.09.36. #### Regulation .10 Appeal Procedures. *COMAR 10.09.13.10* Appeal procedures for this chapter are set forth in COMAR 10.09.36. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.13.11* The interpretive regulation for this chapter is set forth in COMAR 10.09.36. ### Chapter 14 — Vision Care Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1976 (2:29 Md. R. 1740) **Administrative History:** Chapter revised September 14, 1977 (4:19 Md. R. 1469) **Administrative History:** Regulations .01, .04, and .05 amended as an emergency provision effective January 1, 1993 (20:2 Md. R. 108); amended permanently effective July 1, 1993 (20:12 Md. R. 996) **Administrative History:** Regulation .01 amended effective November 29, 1999 (26:24 Md. R. 1858) **Administrative History:** Regulation .01A amended effective March 12, 1984 (11:5 Md. R. 463) **Administrative History:** Regulation .01B amended effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .01J amended effective January 1, 1983 (9:25 Md. R. 2483) **Administrative History:** Regulation .03D, I—K amended effective November 29, 1999 (26:24 Md. R. 1858) **Administrative History:** Regulation .03F amended effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .03J amended effective January 6, 1983 (9:26 Md. R. 2572) **Administrative History:** Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .04 amended effective November 29, 1999 (26:24 Md. R. 1858) **Administrative History:** Regulation .04A and B amended effective January 1, 1983 (9:25 Md. R. 2483) **Administrative History:** Regulation .04B amended effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .05 amended effective November 29, 1999 (26:24 Md. R. 1858) **Administrative History:** Regulation .05A amended effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .05B amended effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .06 amended effective November 29, 1999 (26:24 Md. R. 1858) **Administrative History:** Regulation .06A amended effective April 17, 1981 (8:8 Md. R. 721) **Administrative History:** Regulation .06B amended effective October 10, 2005 (32:20 Md. R. 1655) **Administrative History:** Regulation .06D adopted effective April 4, 1980 (7:7 Md. R. 708) **Administrative History:** Regulation .07 amended effective November 29, 1999 (26:24 Md. R. 1858); October 10, 2005 (32:20 Md. R. 1655); July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07C amended effective April 17, 1981 (8:8 Md. R. 721) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) **Administrative History:** Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .07D amended effective August 10, 1987 (14:16 Md. R. 1774); January 2, 1995 (21:26 Md. R. 2186) **Administrative History:** Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625); March 24, 2008 (35:6 Md. R. 698); January 12, 2009 (36:1 Md. R. 21); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .07H amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended until June 1, 1979 (6:12 Md. R. 1045); adopted permanently effective June 1, 1979 (6:11 Md. R. 979) **Administrative History:** Regulation .07I amended effective April 4, 2011 (38:7 Md. R. 430) **Administrative History:** Regulation .07M amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .07M amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07M amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07M amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) #### Regulation .01 Definitions. *COMAR 10.09.14.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquisition cost” means actual cost of a product to a provider. (2) “Board” means the State Board of Examiners in Optometry. (3) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (4) “Diagnostically certified optometrist” means a licensed optometrist who is certified by the Board to administer topical ocular diagnostic pharmaceutical agents to the extent permitted under Health Occupations Article, §11-404, Annotated Code of Maryland. (5) “EPSDT partial screen” means less than the complete package of various screening procedures required by the State Periodicity Schedule that an EPSDT participant receives at a given age. (6) “EPSDT screen” means EPSDT screen as defined in COMAR 10.09.23.01. (7) “Invoice” means a form designated by the Department for use by providers in submitting bills for payment. (8) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (9) “Ophthalmologist” means a physician skilled in diseases of the eye. (10) “Ophthalmic lenses or optical aids” means a lens, contact lens, prism, or vision aid which has a therapeutic effect on a patient, or which will contribute to the visual welfare of a patient. (11) “Optician” means an individual, partnership, or company which meets applicable licensing requirements as a qualified grinder or dispenser of ophthalmic lenses or optical aids, and which is capable of translating, filling, and adapting ophthalmic prescriptions, products, and accessories. (12) “Optometric clinic or center” means a facility, which provides services for patients under the supervision of a licensed optometrist. (13) Optometric Examination. (a) “Optometric examination” means a series of tests and measurements used to determine the extent of visual impairment, or the correction required to improve visual acuity, performed by a licensed optometrist. (b) “Optometric examination” includes as a minimum: (i) Reviewing a patient's history, past prescriptions, and specifications when available; (ii) Visual analysis; (iii) Ophthalmoscopy of internal eye; (iv) Tonometry without anesthetic when indicated or for a patient 40 years old or older; (v) Muscle balance examination; (vi) Gross visual field testing when indicated; (vii) Writing of lens formula and other prescription data when needed, as well as specific instructions for future care; (viii) Other tests when indicated by §B(12)(b)(i)—(vii) of this regulation; and (ix) Subsequent progress evaluations when indicated. (14) “Optometrist” means an individual who is licensed by the Board to practice optometry or by the state in which the service is rendered. (15) “Orthoptic treatment” means the use of instruments to measure and enhance the binocular coordination of the eyes (a category of “visual training”). (16) Practice Optometry. (a) “Practice optometry” means, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland, to use any means known in the science of optics or eye care, except surgery, to: (i) Detect, diagnose, and treat any optical or diseased condition in the human eye; (ii) Prescribe eyeglasses or lenses to correct any optical or visual condition in the human eye; (iii) Give advice or direction on the fitness or adaptation of eyeglasses or lenses to an individual for the correction or relief of a condition for which eyeglasses or lenses are worn; and (iv) Use, or permit the use of an instrument, test card, test type, test eyeglasses, test lenses, or other device to aid in choosing eyeglasses or lenses for an individual to wear. (b) “Practice optometry” includes, subject to Health Occupations Article, §§11-404 and 11-404.2, Annotated Code of Maryland: (i) The administration of topical ocular diagnostic pharmaceutical agents; (ii) The administration and prescription of therapeutic pharmaceutical agents; and (iii) The removal of superficial foreign bodies from the cornea and conjunctiva. (17) “Preauthorization” means an approval required from the Department or its designee before providing services. (18) “Prescriber” means a physician or optometrist licensed to prescribe optical aids, and authorized by the Department to participate in the Program. (19) “Prescription” means a written order for treatment or optical aids, or both, signed by the prescriber. (20) “Program” means the Maryland Medical Assistance Program. (21) “Progress evaluation” means a follow-up visit, when indicated, to determine the effectiveness of an eye examination, prescription, or series of orthoptic treatments. (22) “Provider” means a physician (when dispensing ophthalmic lenses or visual aids), optometrist, optometric clinic or center, or optician, recognized by the Department to participate in the Program. (23) “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. (24) “Routine adjustment” means an adjustment made to an optical aid other than an adjustment required because of damage. (25) “Screening” means tests or measurements, other than an eye examination, performed to discover the possibility of difficulty in vision. (26) “Therapeutically certified optometrist” means a licensed optometrist who is certified by the Board to administer or prescribe therapeutic pharmaceutical agents or remove superficial foreign bodies from a human eye, adnexa, or lacrimal system to the extent permitted under Health Occupations Article, §11-404.2, Annotated Code of Maryland. (27) “Visual training” means use of instruments or other means to measure and enhance the binocular coordination of the eyes and visual perceptual functions. #### Regulation .02 License Requirements. *COMAR 10.09.14.02* A. An optometrist shall be licensed to practice optometry in the state in which service is provided. B. An optician shall meet the legal requirements of the state in which the service is provided. C. An ophthalmologist shall be licensed to practice medicine in the state in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.14.03* To participate in the Program, the provider shall: A. Apply for participation in the Program using the application form designated by the Department; B. Be approved for participation by the Department; C. Verify the recipient's eligibility; D. Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee; E. Provide service without regard to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap; F. Not knowingly employ an optometrist, optician, or physician to provide services to Medical Assistance patients after that optometrist, optician, or physician has been disqualified from the Program, unless prior approval has been received from the Department. G. Accept payment by the Department as payment in full for services rendered and make no additional charge to any person or covered services; H. Use first quality materials that meet the criteria established by the Department; I. Place no restriction on a recipient's right to select providers of the recipient's choice; J. Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary, the provider may not seek payment for that service from the recipient; K. Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient. #### Regulation .04 Covered Services. *COMAR 10.09.14.04* A. The program covers the following vision care services: (1) A maximum of one optometric examination every 2 years for recipients 21 years old or older and a maximum of one every year for recipients younger than 21 years old, to determine the extent of visual impairment or the correction required to improve visual acuity, unless the time limitations are waived by the Department, based on medical necessity; (2) Subject to §B, of this regulation, a maximum of one pair of eyeglasses every year, unless the time limitations are waived by the Department, based on medical necessity; (3) Examination and eyeglasses for a recipient with a medical condition, other than normal physiological change necessitating a change in eyeglasses (before the normal time limits specified in §§A and B of this regulation have been met) when a preauthorization has been procured; (4) Visually necessary optometric care rendered by an optometrist when these services are: (a) Provided by the optometrist or a licensed employee; (b) Related to the patient's health needs as diagnostic, preventive, curative, palliative, or rehabilitative services; and (c) Adequately described in the patient's record; and (5) Optician services when the services are: (a) Provided by the optician, optometrist, or ophthalmologist, or by an employee under the optician's, optometrist's, or ophthalmologist's supervision and control; (b) Adequately described in the patient's record; (c) Ordered or prescribed by an ophthalmologist or optometrist. B. Eyeglasses. (1) The eyeglasses under §A(2) of this regulation shall have first quality, impact resistant lenses, except in cases where prescription requirements cannot be met with impact resistant lenses. Frames shall be made of fire-resistant, first-quality material. (2) In order to be entitled to receive eyeglasses under §A(2) of this regulation, a recipient shall meet at least one of the following conditions: (a) The recipient requires a diopter change of at least 0.50; (b) The recipient requires a diopter correction of less than 0.50 and this has been preauthorized according to Regulation .06, of this chapter, based on medical necessity; (c) The recipient's present eyeglasses have been damaged to the extent that they affect visual performance and cannot be repaired to effective performance standards, or are no longer usable due to a change in head size or anatomy; or (d) The recipient's present eyeglasses have been lost or stolen. #### Regulation .05 Limitations. *COMAR 10.09.14.05* A. The following are not covered: (1) Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients 21 years old and older; (2) Eyeglasses, ophthalmic lenses, optical aids, and optician services rendered to recipients which were not ordered as a result of a full or partial EPSDT screen; (3) Repairs, except when repairs to eyeglasses are more cost-effective than replacing with new eyeglasses; (4) Combination or metal frames except when required for proper fit; (5) Cost of travel by the provider; (6) A general screening of a Medical Assistance population; (7) Visual training sessions which do not include orthoptic treatment; (8) Routine adjustment. B. An optometrist certified by the Board as qualified to administer diagnostic pharmaceutical agents may use the following agents in strengths not greater than the strengths indicated: (1) Agents directly or indirectly affecting the pupil of the eye, including the mydriatics and cycloplegics listed below: (a) Phenylephrine hydrochloride (2.5 percent); (b) Hydroxyamphetamine hydrobromide (1 percent); (c) Cyclopentolate hydrochloride (0.5—2 percent); (d) Tropicamide (0.5 and 1 percent); (e) Cyclopentolate hydrochloride (0.2 percent) with Phenylephrine hydrochloride (1 percent); (f) Dapiprazole hydrochloride (0.5 percent); and (g) Hydroxyamphetamine hydrobromide (1 percent) and Tropicamide (0.25 percent); and (2) Agents directly or indirectly affecting the sensitivity of the cornea including the: (a) Topical anesthetics listed below: (i) Proparacaine hydrochloride (0.5 percent); and (ii) Tetracaine hydrochloride (0.5 percent); and (b) Diagnostic topical anesthetic and dye combinations listed below: (i) Benoxinate hydrochloride (0.4 percent) — Fluorescein sodium (0.25 percent); and (ii) Proparacaine hydrochloride (0.5 percent) — Fluorescein sodium (0.25 percent). C. An optometrist certified by the Board as qualified to administer and prescribe topical therapeutic pharmaceutical agents is limited to: (1) Ocular antihistamines, decongestants, and combinations of them, excluding steroids; (2) Ocular antiallergy pharmaceutical agents; (3) Ocular antibiotics and combinations of ocular antibiotics, excluding specially formulated or fortified antibiotics; (4) Anti-inflammatory agents, excluding steroids; (5) Ocular lubricants and artificial tears; (6) Tropicamide; (7) Homatropine; (8) Nonprescription drugs that are commercially available; and (9) Primary open-angle glaucoma medications, in accordance with a written treatment plan developed jointly between the optometrist and an ophthalmologist. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.14.06* A. The following services require written preauthorization: (1) Optometric examinations to determine the extent of visual impairment or the correction required to improve visual acuity before expiration of the normal time limitations; (2) Replacement of eyeglasses due to medical necessity or because the eyeglasses were lost, stolen, or damaged before expiration of the normal time limitations; (3) Contact lenses; (4) Subnormal vision aid examination and fitting; (5) Orthoptic treatment sessions; (6) Plastic lenses costing more than equivalent glass lenses unless there are six or more diopters of spherical correction or three or more diopters of astigmatic correction; (7) Absorptive lenses, except cataract; (8) Ophthalmic lenses or optical aids when the diopter correction is less than: (a) -0.50 D. sphere for myopia in the weakest meridian; (b) +0.75 D. sphere for hyperopia in the weakest meridian; (c) +0.75 additional for presbyopia; (d) ±0.75 D. cylinder for astigmatism; (e) A change in axis of 5° for cylinders of 1.00 diopter or more; (f) A total of 4 prism diopters lateral or a total of 1 prism diopters vertical. B. Preauthorization is issued when: (1) Program procedures are met; (2) Program limitations are met; (3) The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. C. Preauthorization is valid only for services rendered or initiated within 60 days of the date issued. D. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A — C of this regulation. #### Regulation .07 Payment Procedures. *COMAR 10.09.14.07* A. Form for Request for Payment. (1) The provider shall submit a request for payment on the form designated by the Department. (2) The request for payment shall document the following, when applicable: (a) Preauthorization; (b) Prescriptions; (c) Need for combination or metal frame; (d) Laboratory invoices. B. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. C. The provider shall charge the Program the provider’s customary charge to the general public for similar professional services. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §F of this regulation;and (2) The provider’s reimbursement is not limited to the provider’s customary charge. D. The provider shall charge acquisition cost for eyeglass frames, eyeglass lenses, contact lenses, and other optical aids. E. Vision care services are reimbursed according to COMAR 10.09.23.01-1. F. The Department will pay professional fees for covered services at the lesser of: (1) The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The Department's fee schedule. G. The Department will pay for materials at acquisition costs not to exceed the maximums established by the Department. H. Payments on Medicare claims are authorized if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that services were medically justified; (4) Services are covered by the Program; (5) Initial billing is made directly to Medicare according to Medicare guidelines. I. Supplemental payment on Medicare claims is made subject to the limitations of the State budget and the following provisions: (1) Deductible insurance will be paid in full; (2) Beginning with August 1, 2010 dates of service, coinsurance shall be paid: (a) In full for the following: (i) Mental health services; (ii) CPT codes that are priced by report; (iii) Claims for anesthesia services; (iv) Claims from a federally qualified health center; and (v) HCPCS codes beginning with A through W; and (b) For all other claims, at the lesser of: (i) 100 percent of the coinsurance amount; or (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare, but covered by the Program, according to §E, of this regulation. J. The provider may not bill the Department for: (1) Services rendered by mail or telephone; (2) Completion of forms and reports; (3) Broken or missed appointments; or (4) Providing a copy of a recipient's patient record when requested by another licensed provider on behalf of the recipient. K. The Department's payment for lenses, frames, case, fitting, and dispensing covers any routine follow-up and adjustments for 60 days, and no additional fees will be paid. L. The Department will make no direct payment to the recipient. M. Payment for contact lenses is made as follows: (1) For the prescription, fitting, training, and adaptation of contact lenses which includes the: (a) Specification of optical and physical characteristics; (b) Fitting of lenses to the wearer; (c) Training of the wearer; (d) Incidental revision of the lenses during training; and (e) Adaptation of the lenses to the wearer; (2) For the supply of contact lenses; and (3) For the follow-up of successfully fitted extended wear lenses. N. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.14.08* A. If the recipient has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the recipient for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. B. A provider shall reimburse the Department for any overpayment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.14.09* A. If the Department determines that a provider, ophthalmologist, optometrist, optician, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from Program; (2) Withholding of payment by the Program; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. C. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. D. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. #### Regulation .10 Appeal Procedures. *COMAR 10.09.14.10* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.14.11* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 15 — Podiatry Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1976 (2:29 Md. R. 1741) **Administrative History:** Chapter revised September 14, 1977 (4:19 Md. R. 1470) **Administrative History:** Regulation .01 amended effective June 14, 1999 (26:12 Md. R. 925) **Administrative History:** Regulation .01B amended effective January 2, 2006 (32:26 Md. R. 1997); August 27, 2007 (34:17 Md. R. 1507); July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .01P adopted effective February 15, 1982 (9:3 Md. R. 221) **Administrative History:** Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .03A amended effective August 21, 2023 (50:16 Md. R. 725) **Administrative History:** Regulation .03J adopted effective January 6, 1983 (9:26 Md. R. 2572) **Administrative History:** Regulation .03K adopted effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .04 amended effective July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .05A amended effective February 15, 1982 (9:3 Md. R. 221) **Administrative History:** Regulation .05A, B amended effective July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .05C amended effective January 2, 2006 (32:26 Md. R. 1997) **Administrative History:** Regulation .06A amended effective April 20, 1979 (6:8 Md. R. 656); September 19, 1980 (7:19 Md. R. 1806); June 14, 1999 (26:12 Md. R. 925) **Administrative History:** Regulation .06B amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .06C amended effective July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .06D adopted effective April 4, 1980 (7:7 Md. R. 708) **Administrative History:** Regulation .07 amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07C amended effective September 19, 1980 (7:19 Md. R. 1806) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) **Administrative History:** Regulation .07D amended effective March 11, 1985 (12:5 Md. R. 482) **Administrative History:** Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .07D amended effective February 24, 1997 (24:4 Md. R. 291); June 14, 1999 (26:12 Md. R. 925); June 24, 2002 (29:12 Md. R. 927); August 27, 2007 (34:17 Md. R. 1507); February 27, 2017 (44:4 Md. R. 252) **Administrative History:** Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .07G amended as an emergency provision effective January 8, 1979 (6:2 Md. R. 72); emergency status extended at 6:12 Md. R. 1045; adopted permanently effective June 1, 1979 (6:11 Md. R. 979) **Administrative History:** Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430); July 16, 2018 (45:14 Md. R. 696); August 21, 2023 (50:16 Md. R. 725) **Administrative History:** Regulation .07H amended effective June 14, 1999 (26:12 Md. R. 925); January 2, 2006 (32:26 Md. R. 1997); July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .07J amended effective June 14, 1999 (26:12 Md. R. 925) **Administrative History:** Regulation .07K amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .07K amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1984) **Administrative History:** Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029); July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .09E amended effective July 16, 2018 (45:14 Md. R. 696) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974); January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulation .11 amended effective July 16, 2018 (45:14 Md. R. 696) #### Regulation .01 Definitions. *COMAR 10.09.15.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Ambulatory surgical center” means any distinct, Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. (2) “Board” means the State Board of Podiatric Medical Examiners. (3) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. 1396 et seq. (4) “Emergency services” means treatment for traumatic injury or infection other than athlete's foot or chronic mycotic infection of the nail bed. (5) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the service is provided. (6) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (7) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (8) “Medicare” means the insurance program administered by the Federal Government under Title XVIII of the Social Security Act, 42 U.S.C. 1395 et seq. (9) “Nursing facility” means a skilled nursing facility certified for participation pursuant to Title XVIII or Title XIX of the Social Security Act, or an intermediate care facility certified for participation pursuant to Title XIX of the Social Security Act, which has entered into a provider agreement with the Department. (10) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (11) “Personal hygiene care” means routine hygienic care in the absence of pathology. (12) “Podiatrist” means a Doctor of Podiatry (D.P.M.) who is licensed to practice podiatry by the Board or by the state in which the service is rendered. (13) Practice Podiatry. (a) “Practice podiatry” means to diagnose or surgically, medically, or mechanically treat any ailment of the: (i) Human foot or ankle; (ii) Anatomical structures that attach to the human foot; or (iii) Soft tissue below the midcalf. (b) “Practice podiatry” does not include: (i) Surgical treatment of acute ankle fracture; or (ii) Administration of an anesthetic, other than a local anesthetic. (14) “Preauthorization” means an approval required from the Department or its designee before rendering services. (15) “Program” means the Maryland Medical Assistance Program. (16) “Provider” means an individual, association, partnership, or an incorporated or unincorporated group of podiatrists, duly licensed to provide services for participants, and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. (17) “Routine care” means the cutting or removing of corns and calluses, and the trimming, cutting, clipping, or debriding of toenails. (18) “Utilization control agent” means the organization responsible for reviewing the use of medical services to determine medical necessity and lengths of stay according to professional standards. #### Regulation .02 License Requirements. *COMAR 10.09.15.02* A. The Provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. In order to participate in the Program a podiatrist shall be licensed to practice podiatry in the state in which service is provided. C. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.15.03* A. General requirements for participation in the Program are that a provider shall: (1) Comply with requirements set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. Specific requirements for participation in the Program as a podiatry services provider require that the provider: (1) Ensure that all X-ray or other radiological equipment is inspected and meets the standards established by COMAR 10.14.03, or other applicable standards established by the state in which the service is provided; (2) Not knowingly employ another podiatrist to provide services to Medical Assistance patients after that podiatrist has been disqualified from the Program, unless prior approval has been received from the Department. #### Regulation .04 Covered Services *COMAR 10.09.15.04* The Program covers the following medically necessary services: A. Podiatric services rendered in the podiatrist's office, the participant's home, a hospital, a nursing facility, a free standing clinic, or elsewhere when these services are: (1) Performed by the podiatrist or another licensed podiatrist in the podiatrist’s employ; (2) Performed on the: (a) Human foot or ankle; (b) Anatomical structures that attach to the human foot; or (c) Soft tissue below the midcalf; (3) Clearly related to the participant’s individual medical needs as diagnostic, curative, palliative, or rehabilitative services; and (4) Adequately described on the participant’s medical record. B. Routine podiatric care rendered in an office, home, nursing home, or licensed assisted living facility for participants who have a metabolic, neurologic, or vascular disease affecting the lower extremities, including but not limited to: (1) Arteriosclerosis obliterans (A.S.O., arteriosclerosis of the extremities, occlusive peripheral arteriosclerosis); (2) Buerger’s disease (thromboangiitis obliterans); (3) Peripheral neuropathies involving the feet, associated with: (a) Traumatic injury; (b) Leprosy or neurosyphilis; or (c) Hereditary disorders, such as hereditary sensory radicular neuropathy, angiokeratoma corporis diffusum (Fabry’s) and amyloid neuropathy; and (4) The following conditions, if the patient is under the active care of a doctor of medicine or osteopathy who documents the condition: (a) Diabetes mellitus; (b) Chronic thrombophlebitis; (c) Peripheral neuropathies involving the feet, associated with: (i) Malnutrition and vitamin deficiency such as malnutrition (general and pellagra), alcoholism, malabsorption (celiac disease and tropical sprue), and pernicious anemia; (ii) Carcinoma; (iii) Diabetes mellitus; (iv) Drugs and toxins; (v) Multiple sclerosis; or (vi) Uremia (chronic renal disease). C. Drugs dispensed by the podiatrist in an emergency or drugs which cannot be self-administered within the limitations of COMAR 10.09.03; D. Injectable drugs administered by the podiatrist within the limitations of COMAR 10.09.03; E. Medical equipment and supplies prescribed by the podiatrist within the limitations of COMAR 10.09.12; and F. Emergency services and related follow-up care. #### Regulation .05 Limitations. *COMAR 10.09.15.05* A. The Program does not cover the following under this chapter: (1) Services which are not medically necessary; (2) Investigational or experimental drugs or procedures; (3) Services prohibited by the Maryland Podiatry Act or the State Board of Podiatric Medical Examiners; (4) Services denied by Medicare as not medically justified; (5) Drugs and supplies which are acquired by the podiatrist at no cost; (6) Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take oral medications are documented in the patient's medical record; (7) More than one visit per day unless adequately documented in the patient's medical record as an emergency; (8) Visits by or to the podiatrist solely for the purpose of the following: (a) Prescription or drug pick-up; (b) Collection of specimens for laboratory procedures, except by venipuncture, capillary or arterial puncture; and (c) Interpretation of laboratory tests or panels; (9) Physical therapy; (10) Orthotics and inlays of any type and related services; (11) Disposable medical supplies; (12) Administration of anesthesia as a separate charge; (13) Personal hygiene care; (14) Routine care, except visits for participants who are diabetic or who have a vascular disease affecting the lower extremities; (15) Non-surgical hospital visits; (16) Laboratory or X-ray services not performed by the provider or under the direct supervision of the provider; and (17) Podiatric inpatient hospital services rendered during an admission denied by the utilization control agent or during a period that is in excess of the length of stay authorized by the utilization control agent. B. Routine podiatric care is limited to one visit every 60 days for participants who have diabetes or peripheral vascular diseases that affect the lower extremities when rendered in the podiatrist's office, the participant’s home, or a nursing facility. C. A licensed podiatrist shall perform in a licensed hospital or ambulatory surgical center, subject to the provisions of Health-General Article, §19-351, Annotated Code of Maryland, all surgical procedures of the ankle below the level of the dermis, arthrodeses of two or more tarsal bones, and complete tarsal osteotomies. A licensed podiatrist who performs these procedures in an ambulatory surgical center shall: (1) Have current privileges at a licensed hospital for the same procedures; and (2) Meet the requirements of the ambulatory surgical center. #### Regulation .06 Preauthorization. *COMAR 10.09.15.06* A. Preauthorization is required for any procedure not included in the current fee schedule. B. Preauthorization is issued when: (1) Program procedures are met; (2) The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. C. Preauthorization is valid only for services rendered or initiated within 90 days of the date issued. D. Preauthorization normally required by the Program is waived when the service is covered and approved by Medicare. However, if the entire claim or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require preauthorization according to §§A—C of this regulation. #### Regulation .07 Payment Procedures. *COMAR 10.09.15.07* A. The provider shall submit his request for payment on the form designated by the Department including all required documentation. B. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed. C. The provider shall bill the provider's customary fees, but may not bill a fee in excess of that charged the general public for similar services, except for injectable drugs and dispensed medical supplies, in which case the provider shall charge the Program the provider's acquisition cost. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §D of this regulation; and (2) The provider's reimbursement is not limited to the provider's customary charge. D. The Program shall pay for medically necessary covered services at the lower of the provider's amount billed to the Program or the maximum reimbursement rates set forth in COMAR 10.09.02.07D. E. Payments on Medicare claims are authorized if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that services were medically justified; (4) Services are covered by the Program; (5) Initial billing is made directly to Medicare according to Medicare guidelines. F. Supplemental payment on Medicare claims are made subject to the limitations of the State budget and the following provisions: (1) Deductible insurance will be paid in full; (2) Beginning with August 1, 2010 dates of service, coinsurance shall be paid: (a) In full for the following: (i) Mental health services; (ii) CPT codes that are priced by report; (iii) Claims for anesthesia services; (iv) Claims from a federally qualified health center; and (v) HCPCS codes beginning with A through W; and (b) For all other claims, at the lesser of: (i) 100 percent of the coinsurance amount; or (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare, but by the Program, according to §E above. G. The provider may not bill the Department or the participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; (4) Laboratory or X-ray services not performed by the provider or under the direct supervision of the provider; or (5) Photocopying of medical records when requested by another licensed provider on behalf of the participant. H. The Program will make no direct payment to participants. I. The Program shall reimburse providers for all laboratory services according to the fees established under COMAR 10.09.09.07 and for all radiological services under COMAR 10.09.02.07. J. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.15.08* A. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for or to reimburse the participant for services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. B. A provider shall reimburse the Department for any overpayment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.15.09* A. If the Department determines that a provider, podiatrist, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the Program; (2) Withholding of payment by the Program; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. C. The Department may consult with the Peer Review Committee of the Maryland Podiatry Association. The Department will give consideration to the findings and recommendations of this group. D. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. E. A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants that he or she no longer accepts Medical Assistance before rendering additional services. #### Regulation .10 Appeal Procedures. *COMAR 10.09.15.10* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.15.11* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 16 — Behavioral Health Crisis Services **Authority:** Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: May 27, 2024 (51:10 Md. R. 525) **Administrative History:** Regulation .07C amended effective July 7, 2025 (52:13 Md. R. 655) **Administrative History:** Regulation .07D adopted effective July 7, 2025 (52:13 Md. R. 655) #### Regulation .01 Definitions. *COMAR 10.09.16.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative Services Organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System. (2) “Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department. (3) “Core Service Agency” means the local mental health authority responsible for planning, managing, and monitoring public mental health services at the local level. (4) “Crisis” means the experience of stress, emotional or behavioral symptoms, difficulties with substance use, or a traumatic event that compromises an individual’s ability to function within their current family and living situation, school, workplace, or community, as defined by the individual experiencing the crisis. (5) “Crisis intervention” means the ability to perform or provide crisis assessment, crisis de-escalation, psychoeducation, brief behavioral support, and referral and linkage to appropriate services and supports. (6) “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. (7) “Licensed mental health professional” means a: (a) Psychiatrist; (b) Licensed psychologist; (c) Psychiatric nurse practitioner (CRNP-PMH); (d) Clinical nurse specialist in psychiatric and mental health nursing (APRN-PMH); (e) Licensed certified social worker-clinical (LCSW-C); (f) Licensed clinical alcohol and drug counselor (LCADC); (g) Licensed clinical marriage and family therapist (LCMFT); (h) Licensed clinical professional art therapist (LCPAT); (i) Licensed clinical professional counselor (LCPC); or (j) Properly supervised: (i) Licensed master social worker (LMSW); (ii) Licensed graduate alcohol and drug counselor (LGADC); (iii) Licensed graduate marriage and family therapist (LGMFT); (iv) Licensed graduate professional art therapist (LGPAT); (v) Licensed graduate professional counselor (LGPC); (vi) Licensed certified social worker (LCSW); or (vii) Psychology associate. (8) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. (9) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (10) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (11) “Program” has the meaning stated in COMAR 10.09.36.01. (12) “Provider” means an organization or an individual practitioner furnishing the services covered under this chapter which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number. #### Regulation .02 License Requirements. *COMAR 10.09.16.02* To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02, 10.63.01.05, and 10.63.02.03. #### Regulation .03 Provider Requirements for Participation. *COMAR 10.09.16.03* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. To participate in the Program, a provider of behavioral health crisis services shall: (1) Meet the conditions for licensure and practice as set forth in COMAR 10.63.01, 10.63.02, and 10.63.06; (2) Have clearly defined and written patient care policies; (3) Maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, meets the following requirements: (a) Includes the date of service with service start and end times; (b) Includes the participant’s primary behavioral health complaint or reason for the visit; (c) Includes a brief description of the service provided, including progress notes; (d) Includes an official e-Signature, or a legible signature, along with the printed or typed name, and appropriate title of each individual providing services, including each separate member of the mobile crisis team; (e) Is made available to the Department or its designee as requested; and (f) Complies with all federal statutes and regulations, including but not limited to the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Part 2 and 45 CFR Parts 160 and 164.04. C. To participate in the Program, a mobile crisis team provider shall: (1) Comply with COMAR 10.63.03.20; (2) Be available to provide services outlined in Regulation .05 of this chapter 24 hours a day, 7 days a week; (3) Provide a timely response with a two-person team as described in COMAR 10.63.03.20; (4) Comply with staffing and supervision requirements as described in COMAR 10.63.03.20F; and (5) Ensure all crisis team staff members receive training as required and approved by the Department. D. To participate in the Program, a behavioral health crisis stabilization center provider shall: (1) Comply with COMAR 10.63.03.21; (2) Be open and accessible to walk-ins 24 hours a day, 7 days a week; (3) Comply with the staffing requirements described in COMAR 10.63.03.21E; (4) Maintain the ability to initiate withdrawal management capabilities for all substances as well as initiate medication assisted treatment for opioid use disorder; and (5) Equally accept individuals presenting due to an emergency petition and individuals presenting voluntarily. #### Regulation .04 Participant Eligibility. *COMAR 10.09.16.04* A. A participant is eligible for mobile crisis team services and behavioral health crisis stabilization center services if they are experiencing a crisis as defined in Regulation .01 of this chapter. B. A participant is eligible for behavioral health crisis services if the service is appropriate to the specific provider type listed in Regulation .05 of this chapter. #### Regulation .05 Covered Services. *COMAR 10.09.16.05* A. The Department shall reimburse for the services in §§B—C of this regulation when these services have been documented, pursuant to the requirements in this chapter, as necessary. B. Mobile crisis team services shall: (1) Comply with COMAR 10.63.03.20; (2) Consist of an in-person response by at minimum a two-person team; (3) Include an initial assessment by a licensed mental health professional, which may be rendered via telehealth only when the licensed mental health professional functions as a third team member; (4) Involve the following interventions and objectives: (a) Crisis intervention and stabilization of the individual’s behavioral health crisis; (b) Safety planning; and (c) Referrals to community supports, including behavioral health providers, health providers, or social and other services; and (5) Include mobile crisis follow-up outreach by means of telephone, telehealth, or in-person contact with the individual served, family members, caregivers, or referred providers. C. Behavioral health crisis stabilization center services shall: (1) Comply with COMAR 10.63.03.21; (2) Consist of an initial nursing assessment and physical exam by a registered nurse in collaboration with a physician or psychiatric nurse practitioner; (3) Include an initial evaluation by an approved physician or psychiatric nurse practitioner in accordance with COMAR 10.63.03.21F; (4) Include a crisis assessment completed by a licensed mental health professional; and (5) Involve the following interventions and objectives: (a) Crisis intervention and stabilization of the individual’s behavioral health crisis; (b) Safety planning; (c) Pharmacological interventions, including the ability to initiate withdrawal management capabilities for all substances, and initiate medications for medication assisted treatment for opioid use disorder; and (d) Referrals to community-based services or to higher levels of care as clinically indicated. #### Regulation .06 Limitations. *COMAR 10.09.16.06* A. The Program does not cover the following: (1) Services not delivered in compliance with Regulation .05 of this chapter; (2) Services not medically necessary; (3) Investigational or experimental drugs and procedures; (4) Services solely for the purpose of: (a) Prescribing medication; (b) Administering medication; (c) Drug or supply pick-up; (d) Collecting laboratory specimens; (e) Interpreting laboratory tests or panels; or (f) Administering injections; (5) Separate reimbursement to an employee of a program for services that have been provided by and reimbursed directly to a program; (6) Services provided to or for the primary benefit of individuals other than the participant; (7) Mobile crisis team services rendered by telehealth with the exception of those specified as permissible via telehealth in Regulation .05 of this chapter; (8) Behavioral health crisis stabilization center services rendered by telehealth with the exception of those specified in COMAR 10.63.03.21; (9) Services provided to participants in a hospital inpatient setting; and (10) Services rendered but not appropriately documented. B. Providers may not be reimbursed by the Program for: (1) Behavioral health crisis stabilization center services exceeding 23 hours 59 minutes; (2) Presumptive and definitive drug testing when billed by a behavioral health crisis stabilization center; or (3) Transportation costs. #### Regulation .07 Payment Procedures. *COMAR 10.09.16.07* A. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. B. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. C. For dates of service June 1, 2024 through June 30, 2024, rates for the services outlined in this chapter shall be as follows: (1) For services delivered through a mobile crisis team: (a) Mobile crisis team services — $111.80 per 15-minute unit increment; and (b) Mobile crisis follow-up outreach — $111.80 per 15-minute unit increment. (2) For services delivered through a behavioral health crisis stabilization center: (a) Behavioral health crisis stabilization services — $721.21 per diem; and (b) Office-based evaluation and management services, according to COMAR 10.09.02.07D. D. For dates of service beginning July 1, 2024, rates for the services outlined in this chapter shall be as follows: (1) For services delivered through a mobile crisis team: (a) Mobile crisis team services — $115.15 per 15-minute unit increment; and (b) Mobile crisis follow-up outreach — $115.15 per 15-minute unit increment. (2) For services delivered through a behavioral health crisis stabilization center: (a) Behavioral Health Crisis Stabilization Center — $742.85 per diem; and (b) Office-based evaluation and management services, according to COMAR 10.09.02.07D. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.16.08* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.16.09* Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures for Providers. *COMAR 10.09.16.10* Appeal procedures for providers are as set forth in COMAR 10.09.36.09. #### Regulation .11 Appeal Rights — Denial of Services. *COMAR 10.09.16.11* Appeal procedures for applicants and participants are as set forth in COMAR 10.01.04. #### Regulation .12 Interpretive Regulation. *COMAR 10.09.16.12* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 17 — Physical Therapy Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: July 11, 1980 (7:14 Md. R. 1349) **Administrative History:** Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .07F amended effective October 1, 1982 (9:19 Md. R. 1895) **Administrative History:** Regulation .07F amended as an emergency provision effective July 1, 1982 (9:17 Md. R. 1698); emergency status expired September 30, 1982 **Administrative History:** Regulation .07F amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1171); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) **Administrative History:** Regulation .07F amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .07F amended as an emergency provision effective July 1, 1990 (17:14 Md. R. 1755); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulation .07G amended effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .07L amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07L amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07L amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulations .01—.05 and .07—.11 amended as an emergency provision effective December 2, 1992 (19:26 Md. R. 2282); amended permanently effective June 1, 1993 (20:10 Md. R. 851) **Administrative History:** Regulations .01, .04, and .05 amended as an emergency provision effective February 8, 1995 (22:5 Md. R. 364); emergency status expired May 31, 1995; amended permanently effective June 5, 1995 (22:11 Md. R. 821) **Administrative History:** Chapter revised effective October 24, 2005 (32:21 Md. R. 1708) **Administrative History:** Regulation .01B amended effective August 27, 2018 (45:17 Md. R. 803) **Administrative History:** Regulation .02 amended effective August 27, 2018 (45:17 Md. R. 803) **Administrative History:** Regulation .03 amended effective August 27, 2018 (45:17 Md. R. 803); August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .04 amended effective August 27, 2018 (45:17 Md. R. 803) **Administrative History:** Regulation .04 amended effective August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .06D, F, I amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .06E amended effective November 14, 2011 (38:23 Md. R. 1421); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .06G amended effective April 4, 2011 (38:7 Md. R. 430) **Administrative History:** Regulation .06H amended effective August 27, 2018 (45:17 Md. R. 803) #### Regulation .01 Definitions. *COMAR 10.09.17.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (2) “Direct supervision” means that a licensed physical therapist is personally present and immediately available within the same treatment area as the physical therapy assistant to give aid, direction, and instruction when physical therapy procedures or activities are performed. (3) “Initial evaluation” means the determination of the participant's condition by taking a case history and the administration of appropriate tests on the first visit. Treatment provided at this visit is considered to be part of the initial evaluation. (4) “Medical Assistance Program” means the program of comprehensive medical and other health related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended. (5) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, family, or provider. (6) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395—1395ccc. (7) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (8) “Patient” means a person awaiting or undergoing health care or treatment. (9) “Physical therapist” means an individual licensed by the Maryland Board of Physical Therapy Examiners or similarly licensed or certified by the appropriate licensing body in the state or jurisdiction in which the service is provided and within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland, or within the scope established by the jurisdiction of the provided service. (10) “Physical therapist assistant” means an individual licensed as a physical therapy assistant, working under the direct supervision of a licensed physical therapist, and performing limited physical therapy procedures that are assigned by a licensed physical therapist within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland, or who is otherwise similarly licensed or certified by the appropriate licensing body in the state or jurisdiction where the service is provided and performing therapy procedures within the scope established by the state or jurisdiction of license or certification. (11) “Physical therapy aide” means a nonlicensed person in the employ of a physical therapist. (12) “Physician” means an individual licensed to practice medicine by the state in which the physician's practice is located. (13) “Plan of care” means the plan of treatment aimed at achieving the anticipated functional goals. (14) “Prescriber” means a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist licensed to prescribe physical therapy. (15) “Program” means the Medical Assistance Program. (16) “Progress” means the measurable improvement as related to goals. (17) “Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or similarly licensed or certified to provide health care services for participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. (18) “Treatment order” means a written prescription for physical therapy signed by a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist. #### Regulation .02 Licensure and Certification Requirements. *COMAR 10.09.17.02* A. To provide services as a physical therapist under this chapter, a physical therapist shall be licensed by the State Board of Physical Therapy Examiners of Maryland to practice physical therapy, as defined in Health Occupations Article, Title 13, Annotated Code of Maryland, or by the appropriate licensing body in the jurisdiction where the physical therapy services are performed. B. To provide services as a physical therapist assistant under this chapter, a physical therapist assistant shall be licensed by the State Board of Physical Therapy Examiners of Maryland to practice as a physical therapist assistant as defined: (1) In Health Occupations Article, Title 13, Annotated Code of Maryland; or (2) By the appropriate licensing body in the jurisdiction where the physical therapy assistant services are performed. #### Regulation .03 Conditions for Participation. *COMAR 10.09.17.03* To participate in the Program, the provider shall: A. Comply with all requirements established in COMAR 10.09.36; B. If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department; and C. Maintain the office and medical equipment so that they are free of hazards to the health and safety of participants. #### Regulation .04 Covered Services. *COMAR 10.09.17.04* A. The Physical Therapy Program covers medically necessary physical therapy services ordered in writing by a physician, doctor of dental surgery or of dental medicine, physician assistant, nurse practitioner, nurse midwife, or podiatrist when the services are: (1) Provided by a licensed physical therapist or by a licensed physical therapist assistant under a licensed physical therapist's direct supervision; (2) Provided in the provider’s office, the patient’s home, a domiciliary level facility, or via telehealth in accordance with COMAR 10.09.49 or other subregulatory guidance issued by the Department; (3) Diagnostic, rehabilitative, or therapeutic, and directly related to the written treatment order; (4) Of sufficient complexity and sophistication, or the condition of the patient is such, that the services of a physical therapist are required; (5) Rendered pursuant to a written treatment order which: (a) Is signed and dated by the prescriber; (b) Specifies the following: (i) Part or parts to be treated; and (ii) Expected results of physical therapy treatments; (c) Is kept on file by the therapist as a part of the patient's permanent record, subject to review by the Department or its designee; and (d) Is not altered by the therapist unless: (i) Medically indicated; (ii) Signed by the therapist; (iii) Necessary changes are made; (iv) The prescriber is notified of the change; and (v) The change is noted in the patient's record; and (6) Recorded in the patient's permanent record which includes: (a) The treatment order of the prescriber; (b) The initial evaluation by the therapist and significant past history; (c) All pertinent diagnoses and prognoses; (d) Contraindications, if any; and (e) Progress notes documented in accordance with the requirements listed in COMAR 10.38.03.02-1A(2), C, and D. B. The Physical Therapy Program covers an initial evaluation, on a one-time-only basis, per condition, when the requirements of §A, of this regulation, are met. C. If the prescribing order exceeds 30 days, the therapist shall request a new order from the prescriber for continued therapy. #### Regulation .05 Limitations. *COMAR 10.09.17.05* A. The Program does not cover the following: (1) Services provided in a facility or by a group where reimbursement for physical therapy is covered by another segment of the Program; (2) Services performed by physical therapist assistants when not under the direct supervision of a physical therapist; (3) Services performed by physical therapy aides; or (4) Experimental treatment. B. A physical therapist may only supervise two physical therapy assistants at a time. #### Regulation .06 Payment Procedures. *COMAR 10.09.17.06* A. The provider shall submit the request for payment of services rendered according to procedures established by the Department and in the format designated by the Department. B. The provider shall certify on the invoice that the treatment order is on file and was in effect at the time that services were rendered. C. The provider shall specify on the invoice the type of treatment provided. D. A provider shall bill the Program the provider’s customary charge. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with the rate provisions of §E of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. E. The services covered in this chapter are reimbursed according to COMAR 10.09.23.01-1. F. The Department will pay for covered services, the lesser of: (1) The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The Department's fee schedule. G. Supplemental payment on Medicare claims for patients is made subject to the limitations of the State budget and the following provisions: (1) Deductible insurance will be paid in full; (2) Beginning with August 1, 2010 dates of service, coinsurance shall be paid: (a) In full for the following: (i) Mental health services; (ii) CPT codes that are priced by report; (iii) Claims for anesthesia services; (iv) Claims from a federally qualified health center; and (v) HCPCS codes beginning with A through W; and (b) For all other claims, at the lesser of: (i) 100 percent of the coinsurance amount; or (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare, but covered by the Program, according to §F, in this regulation. H. Payments on Medicare claims are authorized if: (1) The provider accepts Medicare assignment; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that services were medically justified; (4) Services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. I. The provider may not bill the Department for: (1) Services rendered by mail or telephone; (2) Completion of forms and reports; or (3) Broken or missed appointments. J. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. K. The Department may return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Department. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.17.07* Recovery and reimbursement for this chapter are as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.17.08* A. Cause for suspension or removal and imposition of sanctions for this chapter are as set forth in COMAR 10.09.36.08. B. The Department may consult with a peer review committee approved by a local chapter of the American Physical Therapy Association. The Department will give consideration to the findings and recommendations of this group. #### Regulation .09 Appeal Procedures. *COMAR 10.09.17.09* Appeal procedures for this chapter are set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.17.10* The interpretive regulation for this chapter is set forth in COMAR 10.09.36.10. ### Chapter 18 — Oxygen and Related Respiratory Equipment Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-129, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1984 (10:25 Md. R. 2268) **Administrative History:** Regulation .01B amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109); April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .03 amended effective April 16, 2012 (39:7 Md. R. 491); April 13, 2015 (42:7 Md. R. 568) **Administrative History:** Regulation .03D amended effective April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .03H amended effective May 29, 1989 (16:10 Md. R. 1109) **Administrative History:** Regulation .03P, .05, .06F, and .07D, F, G amended effective November 5, 1984 (11:22 Md. R. 1899) **Administrative History:** Regulation .04 amended effective November 5, 1984 (11:22 Md. R. 1899); May 2, 1988 (15:9 Md. R. 1108); May 29, 1989 (16:10 Md. R. 1109) **Administrative History:** Regulation .04B amended effective September 11, 2017 (44:18 Md. R. 866) **Administrative History:** Regulation .04B, F amended effective April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .04F amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .05B amended effective May 2, 1988 (15:9 Md. R. 1108); April 5, 2010 (37:7 Md. R. 570); September 11, 2017 (44:18 Md. R. 866) **Administrative History:** Regulation .06 amended effective October 27, 2003 (30:21 Md. R. 1529); April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .07 amended effective April 5, 2010 (37:7 Md. R. 570) **Administrative History:** Regulation .07C, E, M amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 **Administrative History:** Regulation .07D amended effective August 12, 1985 (12:16 Md. R. 1606) **Administrative History:** Regulation .07D amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 1, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .07D amended effective May 2, 1988 (15:9 Md. R. 1108); October 27, 2003 (30:21 Md. R. 1529); April 2, 2012 (39:6 Md. R. 408): February 3, 2014 (41:2 Md. R. 91); June 14, 2021 (48:12 Md. R. 473) **Administrative History:** Regulation .07E amended effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .07O amended effective September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07O amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07O amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84) #### Regulation .01 Definitions. *COMAR 10.09.18.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Concentrator” means a device which removes nitrogen from ambient air, thus increasing the percentage of oxygen, and delivers the resulting oxygen-enhanced air to the patient. (2) “Current stable arterial blood gas results” means stable arterial blood gas results on room air within 1 month before the requested date of submission of the form designated by the Department. (3) “Demurrage” means a charge imposed by a provider for the detention of an oxygen cylinder or other equipment. (4) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Emergency services” means unscheduled deliveries or maintenance visits to the home or nursing home by the provider because of a threat to the patient's life caused by insufficient supply of oxygen or equipment malfunction. (6) “Home” means the place of residence occupied by the recipient, other than a hospital or a nursing facility. (7) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-301 et seq., Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the State in which the service is provided. (8) “Intermittent Positive Pressure Breathing (IPPB) Equipment” means an apparatus designed to force a combination of ambient air or medication, or both, into a patient's respiratory system. (9) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (10) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (11) “Nasal continuous positive airway pressure (NCPAP) system” means a noninvasive apparatus designed to maintain air or oxygen, or both, under constant positive pressure through the nose during sleep. (12) “Nursing facility” means a Comprehensive Care Facility which falls within the jurisdiction of the Health-General Article, §19-301 et seq., Annotated Code of Maryland, or other applicable standards established by the State in which the service is provided. (13) “Oxygen” means pure liquid or gaseous oxygen, not in combination with other medical gases, packaged in suitable safe containers for administration to patients. (14) “Prepayment authorization” means the approval required from the Department or its designee before services can be rendered. (15) “Prescriber” means a physician licensed to prescribe oxygen and related respiratory equipment in the state in which the service is provided. (16) “Program” means the Maryland Medical Assistance Program. (17) “Provider” means an individual, association, partnership, or incorporated or unincorporated group of individuals who, through an appropriate agreement with the Department, has been identified as a Program supplier of oxygen and related respiratory equipment by the issuance of an individual account number. (18) “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. (19) “Related respiratory equipment” means accessories used to move, direct, measure, or control the flow of oxygen from its container, or from a concentrator, to the patient. #### Regulation .02 (Reserved) *COMAR 10.09.18.02* #### Regulation .03 Conditions for Participation. *COMAR 10.09.18.03* To participate in the Program, the provider shall: A. Unless exempt from Medicare accreditation requirements: (1) Be accredited by a Medicare-approved accreditation organization; (2) Effective November 1, 2011, provide documentation of: (a) Accreditation; or (b) Having submitted an application for accreditation; and (3) Effective April 1, 2012, be accredited or terminated from the Program; B. Apply for participation in the Program using the application form designated by the Department; C. If located more than 25 miles from the border of Maryland, shall provide to the Program documentation demonstrating that the enrollment and screening requirements of 42 CFR Part 455, Subpart E have been performed within the 12 months preceding the application for initial enrollment or revalidation of enrollment by: (1) A Medicare contractor; or (2) The Medicaid agency or the Children’s Health Insurance Program of another state; D. Be approved for participation by the Department; E. Verify the recipient's eligibility; F. Maintain for a minimum of 6 years adequate records which are sufficient in detail to support the invoices submitted for payment, and make these records available upon request to the Department or its designee; G. Provide service without discrimination as to race, creed, color, age, sex, national origin, marital status, or physical or mental handicap; H. Not knowingly employ a former Medicaid provider, or a former employee of a Medicaid provider, to provide service to Medical Assistance patients after that provider or employee has been disqualified from the Program, unless prior approval has been received from the Department; I. Accept payment by the Department as payment in full for services rendered, and make no additional charge to any person for covered services; J. Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the recipient; K. Agree that if the Program denies payment due to late billing, he may not seek payment from the recipient; L. Place no restriction on a recipient's right to select providers of the recipient's choice; M. Have emergency services available on a 24 hour-a-day basis; N. Be prepared to furnish necessary maintenance and repairs to oxygen and related respiratory equipment; O. Insure on every visit to the patient that all oxygen and related respiratory equipment functions properly; P. Provide suitable identification, including a recent photograph, which employees who visit patients at home will carry on their person and display on request; Q. Agree to discontinue billing or remove equipment promptly, if the patient dies, is institutionalized, or otherwise ceases to require the oxygen; R. Provide an ancillary source of oxygen to last at least 24 hours when the primary source is a concentrator. #### Regulation .04 Covered Services. *COMAR 10.09.18.04* A. The following medically necessary items and services are covered for pulmonary use in the patient's home or nursing facility pursuant to §§B, C, D, and E of this regulation: (1) Rental or purchase for use in patient's home or nursing facility of: (a) Oxygen, gaseous (tank contained); (b) Oxygen, liquid. (2) Rental of concentrators. (3) Rental or purchase of the following related respiratory equipment: (a) Rental of equipment included in complete oxygen set-up: (i) Flow meter; (ii) Humidity jar; (iii) Nasal cannula; (iv) Oxygen face mask; (v) Regulator; (vi) Safety stand; (vii) Tubing; (b) Rental of portable oxygen unit; (c) Rental or purchase of the following tracheostomy equipment: (i) Trach tubes; (ii) Tracheostomy trays; (iii) Humidity system, complete set-up to include tracheostomy collar or T-tube, tubing, humidity jar, and compressor; (iv) Heater; (v) Water trap; (d) Other related equipment: (i) Rental or purchase of aerosol compressor (complete set-up) to include compressor unit, medication cup, connector fitting, tubing, hand-held nebulizer, and mouthpiece, face mask, or tracheostomy collar or T-tube; (ii) Rental or purchase of ultrasonic nebulizer (complete set-up) to include ultrasonic aerosol chamber with blower, medication cup, connector fitting, corrugated tubing, and mouthpiece, face mask, or tracheostomy collar or T-tube; (iii) Resuscitator bag, manual. (4) Rental or purchase of an intermittent positive pressure breathing (IPPB) machine (complete set-up) to include: (a) Compressor; (b) Medication cup; (c) Nebulizer; (d) Connector fitting; (e) Corrugated tubing; (f) Nebulizer hose; (g) Exhalation hose; (h) Exhalation valve; and (i) Mouthpiece. (5) Rental or purchase of a nasal continuous positive airway pressure (NCPAP) system (complete set-up) to include: (a) Flow generating device; (b) Valve mechanism to maintain pressure; (c) Nasal mask and headgear; and (d) Tubing and reservoir. (6) Repairs to purchased respiratory equipment. (7) Replacement items for purchased equipment. B. The items in §A(1), (2), and (3)(a) and (b) of this regulation are covered when: (1) The patient's current stable arterial blood gas results (at rest, using room air) for PaO2 are 60 mm Hg or less after optimal treatment; or (2) The patient’s saturation level is 88 percent or less on room air or less than 93 percent for patients younger than 21 years old; or (3) The patient's: (a) Baseline study demonstrates sleep apnea or disordered breathing events, or both, (hourly rates >30 episodes/hour) with oxygen desaturation (oxyhemoglobin desaturation <85 percent by ear oximetry which is the equivalent to PaO2 <50 mm Hg); and (b) Repeat study on supplemental oxygen demonstrates either a 30 percent reduction in the number of apneic episodes or disordered breathing events, or both, or improved oxyhemoglobin saturation (>85 percent by ear oximetry which is equivalent to PaO2 >50 mm Hg) throughout the night. C. The items in §A(5) of this regulation are covered when the patient's: (1) Baseline study demonstrates more than 30 episodes per hour of obstructive sleep apnea (OSA), each lasting 10 seconds or more, or other disordered breathing events (DBE's), with evidence of clinical impairment (that is, daytime hypersomnolence or cor pulmonale); and (2) Study of NCPAP demonstrates a greater than 90 percent reduction in frequency of OSA or other DBE's, with improvement in clinical symptoms. D. The items in §A(4) of this regulation are covered when the patient's pulmonary function studies show: (1) A vital capacity of less than 1.5 liters (with a normal FEV1; or (2) An absolute FEV1 of 1.5 liters or less. E. The items in §A(3)(d)(i) and (ii) of this regulation are covered when: (1) The patient's pulmonary function studies show an FEV1/FVC percentage of 45 or less (calculated as FEV1 divided by FVC); or (2) Unable to test for §E(1), of this regulation, other objective signs/symptoms of severe airway obstruction. F. The items in §A(1)—(5) of this regulation are covered when they are ordered in writing, by a physician, including documentation that a face-to-face encounter occurred within 6 months before ordering prescribed services, as follows: (1) The physician's initial order and plan of treatment shall include: (a) When prescribing oxygen: (i) Diagnosis and indication for oxygen use; (ii) Liter flow rate per minute (at rest, and when exercising if prescribing portable oxygen); (iii) Number of hours to be used during a 24-hour period; (iv) Description of equipment to include route of administration; (v) Rehabilitative goals; (vi) Hospital discharge or clinical summary; (vii) Current stable arterial blood gas results to include PaO2, PaCO2, and Ph on room air and on oxygen at rest, and, if prescribing portable oxygen, when exercising, or sleep apnea study results. (b) When prescribing aerosol equipment: (i) Diagnosis and indication for use; (ii) Number of hours to be used during a 24-hour period; (iii) Description of equipment to include route of administration; (iv) Rehabilitative goals; (v) Hospital discharge or clinical summary; (vi) Pulmonary function study results. (c) When prescribing tracheostomy equipment: (i) Diagnosis and indication for use; (ii) Description of equipment to include quantity requested, period of time required, and approximate cost; (iii) Rehabilitative goals. (d) When prescribing an NCPAP system: (i) Diagnosis and indication for use; (ii) Specification of NCPAP fixed level; (iii) Rehabilitative goals; (iv) Clinical summary, including appropriate sleep studies. (2) The physician's subsequent orders shall include: (a) When prescribing oxygen for other than sleep apnea, an update of the items listed in §F(1)(a) of this regulation if the patient's condition regarding the need for oxygen has changed since the previous orders; (b) When prescribing oxygen for sleep apnea, an update of the items listed in §F(1)(a) of this regulation; (c) When prescribing aerosol equipment, an update of the items listed in §F(1)(b) of this regulation; (d) When prescribing tracheostomy equipment, an update of the items listed in §F(1)(c) of this regulation; (e) When prescribing an NCPAP system, an update of the items listed in §F(1)(d) of this regulation. (3) The physician's subsequent orders for oxygen when prescribing for sleep apnea shall be made within: (a) One year of the effective date of the initial preauthorization; or (b) At the time the patient's condition is changed by significant intervention, as follows, not to exceed that 1-year period: (i) Significant weight loss of more than 10—15 percent; (ii) Surgical intervention on upper airway; (iii) Tracheostomy; (iv) Positive airway pressure. #### Regulation .05 Limitations. *COMAR 10.09.18.05* A. The Program does not cover: (1) Any service or items not identified in Regulation .04 of this chapter; (2) Demurrage; (3) Charges for delivery; (4) Equipment prescribed primarily to provide comfort or convenience, including, but not limited to, air conditioners and room humidifiers; (5) Items which are investigational or experimental in nature; (6) Oxygen and related equipment not for pulmonary use; (7) Pre-set oxygen for emergency use; (8) Trach string or tape. B. The Program places the following limitations upon covered services: (1) Reimbursement for aerosol equipment will only be provided if a hand held nebulizer has been tried and is not successful, as indicated in the clinical summary; (2) Reimbursement for IPPB machine will only be authorized if the aerosol compressor with the nebulizer kit has been tried and is not successful, as indicated in the clinical summary; (3) Reimbursement may not be made for: (a) Repairs or replacement parts for rented items; (b) Oxygen prescribed on an as-needed basis (PRN); (c) Oxygen prescribed for stand-by purposes; (d) Piped-in oxygen; (e) Oxygen and related respiratory equipment and services provided in a facility or by a group when reimbursement is covered by another segment of the Program; and (4) Payment for portable oxygen will be made only when: (a) It is required in the pursuit of medical treatment; and (b) The medical necessity is indicated for this type of system. #### Regulation .06 Prepayment Authorization Requirements. *COMAR 10.09.18.06* A. The following items require a written prepayment authorization: (1) Nasal continuous positive pressure (NCPAP) system; (2) Custom made tracheostomy tubes; and (3) Intermittent positive pressure breathing (IPPB) machine. B. Prepayment authorization is issued when: (1) Program procedures are met; (2) Program limitations are met; and (3) The Prescriber submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary. C. The prescriber shall submit requests for prepayment authorization in writing using the format and procedures designated by the Department. D. Prepayment authorization, when required, may be requested via a facsimile machine to expedite hospital, nursing facility, or other medical institutional discharge or in emergency situations approved by the Program. In this case, the facsimile of the completed prepayment authorization form shall be followed by a written request, using the original of the form, which shall be submitted immediately to the Department. E. Written prepayment authorization is valid for a period to be determined by the Program but not to exceed a maximum of 365 days beginning with the date of issue by the Program, and is contingent on the recipient's continuing eligibility. F. Prepayment authorization normally required by the Program is waived when the services are covered and approved by Medicare. However, if the entire or any part of a claim is rejected by Medicare, and the claim is referred to the Program for payment, payment will be made for services covered by the Program only if authorization for those services has been obtained before billing. Non-Medicare claims require prepayment authorization according to §§A—E of this regulation. #### Regulation .07 Payment Procedures. *COMAR 10.09.18.07* A. The provider shall submit request for payment on the forms designated by the Department, with attachments when applicable. B. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed and those submitted without required documentation. C. The provider shall charge the Program the provider’s customary charge to the general public for similar items. If the item is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §D of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. D. The Department shall reimburse providers for the purchase of covered services at the lowest of the provider’s customary charge: (1) For items for which Medicare has established a rate: (a) The Department shall pay providers 80 percent of the Medicare rates established on January 1 of each year for oxygen and respiratory equipment and supplies, which shall include all fitting, dispensing, and follow-up care; and (b) For respiratory equipment for which Medicare has established a capped rental rate, the purchase price shall be 9 times the current Medicare monthly rental rate; and (2) For items for which Medicare has not established a rate: (a) Oxygen and respiratory supplies at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or the provider's wholesale cost plus 37.2 percent; (b) Customized equipment or supplies at the provider's choice of the manufacturer's suggested retail price minus 30 percent or the provider's wholesale cost plus 40 percent; and (c) Other oxygen and respiratory equipment at the provider's choice of the manufacturer's suggested retail price minus 41.2 percent or of the provider's wholesale cost plus 27.4 percent. E. The Department shall pay for repairs to purchased oxygen and respiratory equipment in accordance with the following: (1) The provider's choice of wholesale cost plus 37.2 percent or manufacturer's suggested retail price minus 31.4 percent for all materials; and (2) Reasonable charges for labor, not to exceed the customary charges for similar services in the provider’s area unless the service is free to individuals not covered by Medicaid; or (3) Actual charges for repairs done by other than the provider as evidenced by an invoice attached to the bill. F. The Department shall only pay separately for the following replacement items for purchased respiratory equipment, and all other replacement items shall be included in repairs and will be reimbursed according to §E of this regulation: (1) Mouthpiece; (2) Face mask; (3) Tracheostomy collar or T-tube. G. When any individual item or combination of items are provided as part of a complete setup, they may not be invoiced in the Program separately, but under complete setup procedure codes as listed in the fee schedule, except for replacement items as listed in §F of this regulation. H. The Program will approve for payment the least expensive mode of oxygen which is medically suited for the patient's condition. I. The Program will determine, based upon expected duration of medical need, whether oxygen related equipment will be purchased or rented. Once an item has been purchased and paid for in full, and if the Program has contributed in full or in part to the purchase, then title to the equipment shall remain with the Department, and the equipment, after use by the recipient, shall be recovered at the option of the Department. J. Supplemental payment on Medicare claims is made subject to the following provisions: (1) Deductible insurance will be paid in full; (2) Co-insurance will be paid in full; (3) Services not covered by Medicare but by the Program will be paid in accordance with the limitations of §E of this regulation. K. The Department will authorize payment on Medicare claims if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that services were medically justified; (4) The services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. L. The Department may not make direct payments to recipients. M. The provider may not bill the Program for: (1) Services rendered by mail or telephone; (2) Completion of forms or reports; or (3) Broken or missed appointments. N. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. O. Oxygen and respiratory equipment and disposable medical supply rates may be increased at the Program's discretion, when the Program determines in its sole discretion that the Medicare rate creates a barrier to accessing oxygen and respiratory equipment and supplies. P. Refills. (1) For oxygen and respiratory equipment and supplies that are supplied as refills to the original order, providers shall contact the recipient or designee before dispensing the refill in order to ensure that the refilled item is necessary and to confirm any changes and modifications to the order. (2) The provider shall contact recipient or designee regarding the refills no earlier than 7 days before the delivery and shipping date. (3) For subsequent deliveries of refills, the provider shall deliver the items no earlier than 5 days before the end of usage for the current product. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.18.08* A. If the recipient has insurance or other coverage, or if any other person is obligated either legally or contractually to pay for or to reimburse the recipient for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier's notice or remittance advice with his invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.18.09* A. If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the Program; (2) Withholding of payment by the Department; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action. C. The Department will give the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department will establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. D. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that he no longer honors Medical Assistance cards before he renders additional services. #### Regulation .10 Appeal Procedures. *COMAR 10.09.18.10* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.18.11* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 19 — Transportation Grants **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: June 26, 1981 (8:13 Md. R. 1139) **Administrative History:** Regulation .03A amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .07F amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .09A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .11 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .12 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Regulations .01—.12 repealed effective July 1, 1987 (14:4 Md. R. 418) **Administrative History:** Regulations .01—.12 adopted effective July 1, 1987 (14:4 Md. R. 418) **Administrative History:** Regulation .01B amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulations .01B and .05A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulations .01B and .05A amended, and .04G adopted as an emergency provision effective May 1, 1991 (18:7 Md. R. 765); amended permanently effective October 1, 1991 (18:15 Md. R. 1726) **Administrative History:** Regulation .03A—C amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .04A amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .05 amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .06A and B amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .07 amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .07A amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .08C and D amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulations .01—.12, General Transportation, repealed effective May 24, 1993 (20:10 Md. R. 851) **Administrative History:** Regulations .01—.10, Transportation Grants, adopted effective May 24, 1993 (20:10 Md. R. 851) **Administrative History:** Regulation .02B amended effective July 1, 1994 (21:12 Md. R. 1060) **Administrative History:** Regulation .05 amended effective July 1, 1994 (21:12 Md. R. 1060) #### Regulation .01 Scope. *COMAR 10.09.19.01* These regulations govern the administration of grants to counties, municipal corporations, and nonprofit organizations for the provision of safety-net transportation services to Medical Assistance Program recipients. The grant funds are to be used by grantees to: A. Screen requests for transportation by recipients; B. Arrange for transportation; C. Expand existing and develop new transportation resources; and D. Provide transportation services where no other transportation is available to the recipient. #### Regulation .02 Definitions. *COMAR 10.09.19.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Ambulance” means a specially designed vehicle used for transporting the sick or injured, which has necessary patient care equipment including a stretcher, clean linens, first aid supplies, oxygen equipment, and, in addition, other safety and lifesaving equipment which may be required by State or local laws to classify the vehicle as an ambulance. (2) “Attendant” means an individual needed to accompany a recipient who is unable to travel alone. (3) “Department” has the meaning stated in COMAR 10.09.36.01. (4) “Emergency” means a situation requiring prompt diagnosis and treatment of conditions having the potential of causing imminent disability or death. (5) “Emergency services” means services provided in hospital emergency facilities after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in: (a) Placing health in jeopardy; (b) Serious impairment to bodily functions; (c) Serious dysfunction of any bodily organ or part; or (d) Development or continuance of severe pain. (6) “Grantee” means a recipient of grant funds from the Department pursuant to this chapter. (7) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent individuals. (8) “Medicare” has the meaning stated in COMAR 10.09.36.01. (9) “Necessary” has the meaning stated in COMAR 10.09.36.01. (10) “Nonambulatory” means a condition which renders a recipient physically unable to use a bus, taxicab, or private automobile in going to or from a hospital to receive needed medical treatment. (11) “Program” has the meaning stated in COMAR 10.09.36.01. (12) “Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (13) “Wheelchair van” means a van equipped with either a lift tailgate or side lift which is used for loading patients who are nonambulatory but who do not require the use of equipment found in an ambulance. #### Regulation .03 Procedure for Submission of Proposals. *COMAR 10.09.19.03* A. The Secretary shall request proposals for the award of transportation grants. B. An applicant shall include in the applicant's proposal a description of how the applicant intends to carry out the duties required by these regulations. At a minimum, the applicant shall include the following items in the proposal: (1) The criteria which the applicant will use to determine the recipient's need for transportation services; (2) A discussion of how the applicant will arrange and provide transportation; (3) If applicable, a description of how volunteers will be recruited and reimbursed; (4) The reporting methodology that will be used by the grantee; and (5) An itemized budget for administrative costs, including: (a) A staffing plan; (b) Descriptions of individual job responsibilities and salaries; (c) A budget form; and (d) Other pertinent material. C. If an applicant intends to enter into subcontracts for transportation services referred to in §B(2) of this regulation, the applicant shall provide the following information: (1) The names of the subcontractors; (2) The scope of services to be subcontracted; (3) The payment arrangement and payment level; and (4) The plan for monitoring the performance of the subcontractors. #### Regulation .04 Services to Recipients. *COMAR 10.09.19.04* A. A grantee is responsible for arranging or providing nonemergency transportation to and from medically necessary covered services to Medical Assistance recipients and, when necessary, their attendants, who have no other means of transportation available. In carrying out this duty, a grantee: (1) Shall screen recipients' requests for transportation in order to identify whether transportation is available to the recipients from other sources; (2) When determining the appropriate means of transport for a recipient who appears to have a mental or physical disability which would prevent the recipient from using public transportation, shall request documentation prepared by the recipient's physician which indicates that the recipient's medical condition makes it medically contraindicated for the recipient to use public transportation; (3) Shall refer recipients to organizations and programs which might be able to provide transportation and otherwise arrange for transportation when appropriate; (4) Shall encourage the development and expansion of transportation resources such as churches and other community organizations; (5) Shall provide transportation to recipients for whom there is no other transportation resource available, in the most efficient and cost-effective manner possible, including the use of volunteers and charitable organizations whenever possible; and (6) May refuse to pay for transportation services if the recipient requests transportation less than 24 hours before the time the transportation is to be provided. B. Screening referred to in §A(1) of this regulation includes obtaining the information listed below, as appropriate: (1) Whether a recipient or a member of the recipient's household owns a vehicle; (2) Availability of vehicles owned by friends or relatives with whom a recipient does not share a household; (3) Availability of a volunteer using a privately owned vehicle; (4) Availability of a volunteer from a public or private agency; (5) Availability of transportation services provided for free by any other city, county, or State agency programs; (6) Methods by which a recipient previously reached medical services or currently reaches nonmedical services, such as the grocery store; (7) Whether a recipient can walk to the medical service; (8) Whether public bus transportation operates between a recipient's home and medical service; (9) Whether a recipient is mentally or physically disabled; (10) Whether a recipient is chronically ill or otherwise requires medical services on a frequent and ongoing basis; and (11) Whether a recipient can reschedule an appointment to a time when transportation would be available. C. When the recipient is unable without assistance to obtain the documentation referred to in §A(2) of this regulation, and has no family member or other representative who can provide assistance, the grantee shall offer to contact the recipient's health care provider to request documentation of disability. #### Regulation .05 Limitations. *COMAR 10.09.19.05* Monies from a grant provided under these regulations may not be used to pay for the following: A. Emergency transportation services; B. Medicare ambulance services; C. Transportation to or from Veterans Administration hospitals unless it is to receive treatment for a non-military-related condition; D. Transportation to or from any correctional institutions; E. Transportation of recipients committed by the courts to mental institutions; F. Transportation between a nursing facility and a hospital, for routine diagnostic tests, nursing services, or physical therapy which can be performed at the nursing facility; G. Transportation services from a facility for treatment when the treatment is provided by the facility in which the recipient is located; H. Transportation to receive nonmedical services; I. Gratuities of any kind; J. Transportation between a medical day care facility and the recipient's home; K. Transportation to or from a State facility while the patient is a resident of that facility; L. Transportation of non-Medical Assistance recipients; M. Trips for purposes related to education, recreational activities, or employment; N. Transportation of anyone other than the recipient, except for an attendant accompanying a minor or when an attendant is medically necessary; O. Wheelchair van service for ambulatory recipients; P. Ambulance service for a recipient who does not need to be transported in a prone position; Q. Transportation between a community rehabilitation program (CRP) and the recipient's home; R. Transportation between a day habilitation program and the recipient's home; S. Transportation to or from services that are not medically necessary. #### Regulation .06 Notices to Recipients. *COMAR 10.09.19.06* Whenever a grantee determines that the grantee will not arrange or provide transportation for a recipient who has requested transportation at least 24 hours in advance, even though the recipient has no available transportation resource, the grantee shall send the recipient a notice on a form, approved by the Department, that states the recipient has a right to a fair hearing pursuant to COMAR 10.09.24.13. #### Regulation .07 Documentation. *COMAR 10.09.19.07* A grantee shall document the following items and make the documentation available to the Department upon request: A. Whether the recipient had other transportation available or could reschedule the appointment to a time when transportation would be available; B. That any transportation paid for out of grant funds was to or from a medically necessary service for a recipient; and C. Which recipients the grantee denied transportation and the reason or reasons why. #### Regulation .08 Accountability. *COMAR 10.09.19.08* The Department shall: A. Follow all applicable policies required by COMAR 10.04.04 when approving grants; and B. Reconcile each grant on a yearly basis. #### Regulation .09 Responsibility to Recipients. *COMAR 10.09.19.09* A grantee is expected to meet the transportation needs of recipients in a grantee's county out of grant funds. In those circumstances when the grant funds are insufficient, the grantee shall contact the Program's staff specialist for transportation services, who shall evaluate and assist in resolving transportation requests. A grantee may not refuse services or assistance to a recipient who requests transportation on the basis that the grantee's grant funds have been exhausted. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.19.10* These regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 20 — Community Personal Assistance Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: June 27, 1980 (7:13 Md. R. 1279) **Administrative History:** Regulation .01F-1—F-3 and .06E adopted, and Regulations .05B; .06B, D; and .07B, B-1, C amended as an emergency provision effective July 1, 1986 (13:15 Md. R. 1729); emergency status expired November 30, 1986 **Administrative History:** Regulation .01F-1—F-3 adopted effective December 1, 1986 (13:21 Md. R. 2321) **Administrative History:** Regulation .01F-4—F-6 adopted effective July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulation .01I-1 and J-1 adopted effective April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .02B amended effective April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .03A and B amended effective January 6, 1983 (9:26 Md. R. 2572); January 30, 1984 (11:2 Md. R. 113); April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulations .03A, B, .05, .07C amended as an emergency provision effective July 1, 1983 (10:13 Md. R. 1177); adopted permanently effective October 24, 1983 (10:21 Md. R. 1902) **Administrative History:** Regulation .03A-1 adopted effective April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .03A-2 adopted effective July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulation .03B-1 adopted effective July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulations .04 and .05B, D amended effective April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .04C amended effective October 22, 1984 (11:21 Md. R. 1813) **Administrative History:** Regulation .04D, E, F adopted effective July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulation .05B amended effective December 1, 1986 (13:21 Md. R. 2321); July 17, 1995 (22:14 Md. R. 1053) **Administrative History:** Regulation .06B and D amended, and E adopted effective December 1, 1986 (13:21 Md. R. 2321) **Administrative History:** Regulation .06F adopted effective July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulation .07A amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584); April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .07B amended effective August 30, 1982 (9:17 Md. R. 1708); May 1, 1983 (10:8 Md. R. 726); December 1, 1986 (13:21 Md. R. 2321); December 28, 1998 (25:26 Md. R. 1925) **Administrative History:** Regulation .07B-1 adopted effective April 6, 1986 (13:7 Md. R. 795); amended effective December 1, 1986 (13:21 Md. R. 2321) **Administrative History:** Regulation .07B-2 adopted effective July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulation .07C amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1172); adopted permanently effective October 29, 1984 (11:21 Md. R. 1813) **Administrative History:** Regulation .07C amended effective December 1, 1986 (13:21 Md. R. 2321); December 28, 1998 (25:26 Md. R. 1925) **Administrative History:** Regulation .07D adopted effective July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulation .07D amended effective December 28, 1998 (25:26 Md. R. 1925) **Administrative History:** Regulation .08A, B amended effective April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .09A, B amended effective August 17, 1981 (8:16 Md. R. 1365) **Administrative History:** Regulations .09A, C, D and .10A amended effective April 6, 1986 (13:7 Md. R. 795) **Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974) **Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106) **Administrative History:** Chapter revised effective February 20, 1989 (16:3 Md. R. 342) **Administrative History:** Regulations .01B and .05A amended as an emergency provision effective July 17, 1990 (17:16 Md. R. 1984); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Chapter revised as an emergency provision effective July 30, 1991 (18:17 Md. R. 1911); adopted permanently effective December 1, 1991 (18:23 Md. R. 2488) **Administrative History:** Regulations .01, .03, .05, and .07 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); emergency status expired December 31, 1998 **Administrative History:** Regulations .01, .03, .05, and .07 amended effective September 6, 1999 (26:18 Md. R. 1376) **Administrative History:** Regulation .01B amended effective January 31, 2005 (32:2 Md. R. 146); August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .01B amended effective November 14, 2011 (38:23 Md. R. 1421) **Administrative History:** Regulation .02 amended effective March 22, 2010 (37:6 Md. R. 477) **Administrative History:** Regulation .03 amended effective January 31, 2005 (32:2 Md. R. 146); August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .03A amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .03A amended effective March 22, 2010 (37:6 Md. R. 477) **Administrative History:** Regulation .04 amended effective January 31, 2005 (32:2 Md. R. 146) **Administrative History:** Regulation .04B amended effective November 14, 2011 (38:23 Md. R. 1421) **Administrative History:** Regulation .04D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .04E, F repealed effective August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .05 amended effective January 31, 2005 (32:2 Md. R. 146) **Administrative History:** Regulation .05A, F amended effective November 14, 2011 (38:23 Md. R. 1421) **Administrative History:** Regulation .05B amended effective August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .06B amended effective August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .06C amended effective November 14, 2011 (38:23 Md. R. 1421) **Administrative History:** Regulation .06D amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .07 amended effective August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 2008 (35:16 Md. R. 1389); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) **Administrative History:** Regulation .07 amended effective December 24, 2012 (39:25 Md. R. 1612) **Administrative History:** Regulation .07B, C amended effective May 4, 2009 (36:9 Md. R. 651); December 13, 2010 (37:25 Md. R. 1738) **Administrative History:** Regulation .07D amended effective March 22, 2010 (37:6 Md. R. 477) **Administrative History:** Regulations .01—.11, Personal Care Services, repealed and new Regulations .01—.20, Community Personal Assistance Services, adopted effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .01B amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .04A amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .05A amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .09A amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .10 amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .10B amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .11 amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .13B amended effective December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .14 amended effective January 30, 2017 (44:2 Md. R. 84); May 20, 2019 (46:10 Md. R. 486) #### Regulation .01 Definitions. *COMAR 10.09.20.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means tasks or activities that include, but are not limited to: (a) Bathing and completing personal hygiene routines; (b) Dressing and changing clothes; (c) Eating; (d) Mobility, including: (i) Transferring from a bed, chair, or other structure; (ii) Moving, turning, and positioning the body while in bed or in a wheelchair; and (iii) Moving about indoors or outdoors; and (e) Toileting, including: (i) Bladder and bowel requirements; (ii) Routines associated with the achievement or maintenance of continence; and (iii) Incontinence care. (2) “Applicant” means an individual who is applying to receive services under this chapter. (3) “Assistance” means that another individual: (a) Physically performs the activity for the participant; (b) Physically helps the participant to perform the activity; (c) Monitors the participant’s performance of the activity in order to ensure health and safety; or (d) Cues or encourages the participant to perform the activity. (4) “Certified medication technician (CMT)” means an individual, regardless of title, who: (a) Completes a course in medication administration approved by the Maryland Board of Nursing; (b) Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and (c) Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. (5) “Certified nursing assistant (CNA)” means an individual, regardless of title, who: (a) Is certified by the Maryland Board of Nursing under COMAR 10.39.01; and (b) Routinely performs delegated nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. (6) Community Setting. (a) “Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to: (i) Seek employment and work in competitive integrated settings; (ii) Engage in community life; (iii) Control personal resources; and (iv) Receive services. (b) “Community setting” does not mean: (i) Hospitals; (ii) Nursing facilities; (iii) Institutions for mental diseases; (iv) Intermediate care facilities for individuals with intellectual disabilities; or (v) Other institutions. (7) “Conflicts of interest” means real or seeming incompatibility between one’s private interests and one’s public or fiduciary duties. (8) “Delegated nursing functions” means nursing services provided to a participant by an enrolled personal assistance worker under the supervision of a: (a) Registered nurse in accordance with COMAR 10.27.11; or (b) Nurse practitioner in accordance with COMAR 10.27.07. (9) “Department” means the Maryland Department of Health or its authorized agent acting on behalf of the Department. (10) Home. (a) “Home” means the participant’s place of residence in a community setting. (b) “Home” does not mean: (i) An assisted living program as defined in COMAR 10.07.14; (ii) A residential rehabilitation program licensed as a therapeutic group home under COMAR 10.21.07; (iii) An alternative living unit, group home, or individual family care home as defined in COMAR 10.22.01; (iv) Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; or (v) Any other provider-owned or controlled residence. (11) “Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. (12) “Instrumental activities of daily living” means tasks or activities that include, but are not limited to: (a) Preparing meals; (b) Performing light chores that are incidental to the personal assistance services provided to the participant; (c) Shopping for groceries; (d) Nutritional planning; (e) Traveling as needed; (f) Managing finances and handling money; (g) Using the telephone or other appropriate means of communication; (h) Reading; and (i) Planning and making decisions. (13) “Medicaid” means the Program, administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy participants. (14) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, ameliorative, palliative, or rehabilitative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, the participant’s family, the provider, or the worker. (15) “Nurse” means an individual who is currently licensed to practice nursing in the State under COMAR 10.27.01. (16) “Nurse monitor” means a registered nurse who completes nursing assessments on participants and evaluates the delivery of care. (17) “Participant” means an individual who: (a) Has been determined to meet the qualifications for participation in Community Personal Assistance Services as specified in Regulation .03 of this chapter; and (b) Is enrolled with the Department to receive Medicaid services. (18) “Personal assistance provider agency” means a public or private agency that: (a) Employs or contracts with personal assistance workers; and (b) Has been enrolled by the Program as a provider of personal assistance services. (19) Personal Assistance Services. (a) “Personal assistance services” means assistance specific to the functional needs of a participant with a chronic illness, medical condition, or disability. (b) “Personal assistance services” includes: (i) Assistance with activities of daily living and instrumental activities of daily living; and (ii) The performance of delegated nursing functions. (20) “Plan of service” means the support plan that: (a) Reflects what is important to the individual and what is important for the individual’s welfare; and (b) Is developed with support from the supports planner with input from the individual and, when applicable, the individual’s representative. (21) “Preauthorized” means approved by the Department or its designee before services can be rendered. (22) “Program” means the Maryland Medicaid Program. (23) “Provider” has the same meaning as defined in COMAR 10.09.36. (24) “Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter. (25) “Recommended plan of care” means the recommended service plan developed by a nurse after a face-to-face evaluation of an applicant or participant. (26) “Representative” means: (a) The person authorized by the individual to serve as a representative in connection with the provision of personal assistance services and supports; (b) The individual who signs the plan of service on the participant’s behalf; (c) Any individual who makes decisions on behalf of the participant related to the participant’s plan of service; (d) A legal guardian of the individual for the participant; or (e) The parent or foster parent of a dependent minor child. (27) “Supports planner” means an individual who coordinates services, including: (a) Supporting development of a plan of service; (b) Interacting with third parties on behalf of, or in conjunction with, the applicant or participant; and (c) Ensuring an accurate plan of service is provided to the Department. (28) “Telephonic time-keeping system” means a system developed by the Department for workers to time stamp the start and finish of services provided to a participant. (29) “Worker” means an individual who is employed by or contracts with a personal assistance provider agency to provide personal assistance services. #### Regulation .02 Requirements for Provider Licensing or Certification. *COMAR 10.09.20.02* The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered: A. Registered nurses; B. Licensed practical nurses; C. Certified medication technicians; and D. Certified nursing assistants. #### Regulation .03 Participant Eligibility. *COMAR 10.09.20.03* A. To participate in the Program, the participant shall: (1) Be determined by the Department to need assistance with one or more activities of daily living; (2) Be eligible for Medicaid under an eligibility coverage group described in COMAR 10.09.24, except for Regulations .03C, .03-1—.03-3, and .05-2; and (3) Reside at home. B. To be eligible for participation, a participant shall have an active plan of service. The plan of service shall: (1) Be based on: (a) The evaluation and recommended plan of care; and (b) Consultation with the applicant or participant; (2) Address the applicant’s or participant’s health and safety needs; (3) Specify the services needed to safely support the participant in the community, including a plan for receiving personal assistance services in case of an emergency; (4) Specify the provider agency providing personal assistance services; and (5) Include the signature of the: (a) Participant or, when applicable, the individual’s representative; (b) Supports planner; and (c) Personal assistance provider agency listed within the plan of service. C. A participant’s eligibility for services shall be re-evaluated by the Department every 12 months, or more frequently if needed due to a significant change in the participant’s condition or needs. D. Participant eligibility shall be terminated if the participant: (1) No longer meets the required level of care; (2) No longer resides at home; (3) Is without personal assistance services for 30 consecutive calendar days; (4) Voluntarily chooses, or the participant’s legal representative chooses on the participant’s behalf, to disenroll from the Program; (5) Moves to another state; (6) Is an inpatient for 30 consecutive days or more in an institutional setting, including but not limited to a chronic hospital or nursing facility; or (7) Dies. #### Regulation .04 Conditions for Provider Participation — General Requirements. *COMAR 10.09.20.04* A. To participate as a provider of a service covered under this chapter, a provider: (1) Shall meet all of the conditions for participation as a Medicaid provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; (2) Shall verify the qualifications of all individuals who render services on the provider’s behalf and provide a copy of the current license or credentials on request; (3) Shall implement the reporting and follow-up of incidents and complaints in accordance with the Department’s established policy by: (a) Reporting incidents and complaints within 24 hours of knowledge of the event; (b) Submitting a written report within 7 calendar days on a form designated by the Department; and (c) Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subjected to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.02.16; (4) Shall agree to cooperate with required inspections, reviews, and audits by authorized governmental agents; (5) Shall agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter, for only those services covered under this chapter which have been: (a) Preauthorized in the participant’s plan of service; (b) Provided in a manner consistent with the participant’s plan of service; and (c) Identified in the provider agreement as within the scope of the provider’s Medicaid participation; (6) Shall agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years from the date of service, in a manner approved by the Department; (7) Shall agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and only after consultation and input from the participant or, when applicable, the participant’s representative; (8) Shall submit a transition plan to the case manager or supports planner and participant or, when applicable, the participant’s representative when suspending or terminating services; (9) Shall verify Medicaid eligibility at the beginning of each month that services will be rendered; (10) May not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; and (11) Shall be free from conflicts of interest. B. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: (1) Had a license or certificate suspended or revoked as a health care provider, health care facility, or direct care services worker; (2) Been suspended or removed from participating as a Medicaid provider under COMAR 10.09.84; (3) Undergone the imposition of sanctions under COMAR 10.09.36.08; (4) Been subject to disciplinary action, including actions by the licensing board or any provider or principal of any provider agency; (5) Been cited by a State agency for deficiencies which affect participants’ health and safety; or (6) Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to: (a) Failure to meet contractual obligations; or (b) Fraudulent billing practices. C. A provider who renders health-related services to participants shall agree to: (1) Periodically provide information about a participant in accordance with the procedures and forms designated by the Department; and (2) Share and discuss the documented information at the request of the participant. #### Regulation .05 Specific Conditions for Provider Participation — Personal Assistance. *COMAR 10.09.20.05* A. Personal assistance service providers shall: (1) Be licensed as a residential service agency under COMAR 10.07.05 to provide Level Two or Level Three home care services; (2) Employ a registered nurse who shall: (a) Assess each new participant who requires personal assistance services; (b) Participate in developing the worker instructions and in assigning appropriate personnel; (c) Delegate nursing tasks, as appropriate, to a CNA or a CMT in accordance with COMAR 10.27.11; and (d) Participate in instructing the workers who will provide the assistance, when indicated; (3) Employ workers who will accept instruction on the personal assistance services required in the participant’s plan of service from the following: (a) The participant or, when applicable, the participant’s representative; (b) The nurse monitor; (c) A treating physician or nurse practitioner; or (d) An individual from the Department; (4) Provide services directly through their workers under the direction of the participant or, when applicable, the participant’s representative; (5) Allow participants to have a significant role in the delivery of their specific care including: (a) Directing the services and supports identified in their plan of service; and (b) Exercising as much control as desired to select, train, schedule, determine duties of, and dismiss the personal assistance worker in their home; (6) Notify the Department in writing at least 45 days in advance of any: (a) Voluntary closure; (b) Change of ownership; (c) Change of location; (d) Sale of the business; (e) Change in the name under which the provider is doing business; or (f) Change in provider tax identification number; (7) Include in the notice to the Department the method for informing participants and representatives of its intent to close, change ownership, change location, or sell its business; (8) Include in the notice to the Department, and inform participants and representatives, of the transition plan developed by the agency to ensure continuity of services to participants; (9) If applicable, apply for a new license whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of services; (10) Submit a Medicaid provider application to the Department if the new owner chooses to participate in the Program; and (11) Conduct a criminal history records check on all direct service workers including nurses, in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland. B. A worker who performs delegated nursing services in accordance with COMAR 10.27.11 shall: (1) If required to administer medications in accordance with the plan of service, be a certified medications technician; and (2) If performing other delegated nursing functions, also be a certified nursing assistant. C. A personal assistance provider agency may not assign the participant’s representative to provide services to that participant. #### Regulation .06 Specific Conditions for Provider Participation — Supports Planning. *COMAR 10.09.20.06* To participate in the Program as a supports planning provider under Regulation .10 of this chapter, a provider shall: A. Agree to be monitored by the Department; and B. Be: (1) Identified by the Department through a solicitation process; or (2) The area agency on aging that is enrolled to provide case management services under COMAR 10.09.54. #### Regulation .07 Specific Conditions for Provider Participation — Nurse Monitoring. *COMAR 10.09.20.07* To participate in the Program as a nurse monitoring provider under Regulation .11 of this chapter, a provider shall: A. Be designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act; B. Employ or contract with registered nurses who hold a current professional license to practice in Maryland; C. Agree to accept all referrals from the Department; and D. Agree to be monitored by the Department. #### Regulation .08 Covered Services — General. *COMAR 10.09.20.08* The Program shall reimburse for the services specified in Regulations .09—.11 of this chapter, when, pursuant to the requirements of this chapter, these services have been preauthorized by the Department in the participant’s plan of service, billed in accordance with the payment procedures in Regulation .14 of this chapter, and documented as necessary to prevent institutionalization. #### Regulation .09 Covered Services — Personal Assistance. *COMAR 10.09.20.09* A. The Program covers personal assistance services that are approved in the plan of service and rendered to a participant by a qualified provider in the participant’s home or a community setting. B. The Program covers the following services when provided by a personal assistance provider: (1) Assistance with activities of daily living; (2) Delegated nursing functions if this assistance is: (a) Specified in the participant’s plan of service; and (b) Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing; (3) Assistance with tasks requiring judgment to protect a participant from harm or neglect; (4) Assistance with or completion of instrumental activities of daily living, provided in conjunction with the services covered under §B(1)—(3) of this regulation; and (5) Assistance with the participant’s self-administration of medications, or administration of medications or other remedies, when ordered by a physician. C. Personal assistance services may not include: (1) Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant; (2) The cost of food or meals prepared in or delivered to the home or otherwise received in the community; or (3) Housekeeping services, other than those incidental to services covered under §B of this regulation. #### Regulation .10 Covered Services — Supports Planning. *COMAR 10.09.20.10* A. Supports planning services shall: (1) Address the individualized needs of the participant; (2) Be sensitive to the educational background, culture, and general environment of the participant; (3) Support the participant to self-direct services and exercise as much control as desired to select, train, supervise, schedule, determine duties of, and dismiss the personal assistance provider; and (4) Ensure freedom of choice among any willing provider for all services. B. Supports planning services include the following activities: (1) Assisting the participant in developing a plan of service in consultation with the applicant or participant and any individual requested by the participant; (2) Assisting the participant with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to: (a) Behavioral health; (b) Educational services; (c) Disposable medical supplies and durable medical equipment; (d) Housing; (e) Medical services; and (f) Social services; (3) Monitoring the provision of services to determine if services are received in accordance with the plan of service; (4) Using information technology systems developed by the Department; (5) Coordinating with the fiscal intermediary to assist in managing budgeted resources; (6) Providing guidance and support to help individuals self-direct their services; and (7) Administering funds for transition services. #### Regulation .11 Covered Services — Nurse Monitoring. *COMAR 10.09.20.11* A. The Program covers the following services when provided by a nurse monitor: (1) Being available to give instruction and to answer questions; (2) Complying with the Department’s reportable events policy; and (3) Maintaining an up-to-date client profile in an electronic database designated by the Department. B. The Program covers nurse monitoring services according to the following schedule: (1) Contact with the participant for the purpose of reviewing participant status at a minimum of every 6 months with at least one in-person home or workplace visit every 12 months; and (2) Additional nurse monitoring services at a frequency established in conjunction with the participant or, when applicable, the participant’s representative, based on the participant’s medical condition or clinical status. C. Home and Workplace Visits. (1) The nurse monitoring provider shall use the home or workplace visit for the following purposes: (a) To assess the participant’s condition; (b) To assess the quality of personal assistance services; and (c) To determine the need for discharge from personal assistance services or referral to other services. (2) The nurse monitor shall assess the quality of personal assistance services by: (a) Reviewing documentation related to the provision of personal assistance services; and (b) Observing the performance of the worker, as appropriate. #### Regulation .12 Conditions for Reimbursement. *COMAR 10.09.20.12* The Program shall reimburse for the services specified in Regulations .09—.11 of this chapter, if provided in accordance with the requirements of this chapter, and if the service: A. Is recommended on the participant’s plan of service as necessary to assure the health and safety of an applicant or participant in the community; B. Has been preauthorized by the Department in the participant’s plan of service; C. Is provided to an enrolled participant; D. Is medically necessary; and E. Is provided by a Medicaid provider who meets the conditions for participation under this chapter. #### Regulation .13 Limitations. *COMAR 10.09.20.13* A. The Department shall establish a budget for personal assistance services that may be included in the participant’s plan of service, based on each participant’s assessed need. B. The Program does not cover the following services: (1) Service primarily for the purpose of housekeeping unrelated to the participant’s activities of daily living, such as: (a) Cleaning of the floor and furniture in areas not occupied by the participant; (b) Laundry other than that incidental to the care of the participant; and (c) Shopping for groceries or household items unless in the company of the participant; (2) Meals delivered to the home; (3) Services provided by providers not approved for participation by the Department; (4) Expenses incurred while escorting participants: (a) To obtain medical diagnosis or treatment; (b) To or from the participant’s workplace; or (c) For participation in social or community activities; (5) Expenses related to room and board for either the participant or the worker; or (6) Personal assistance services provided outside the State for more than 30 days per calendar year. C. Payment for supports planning and nurse monitoring services shall be limited to direct services to the participant and may not be made for: (1) Administrative overhead; (2) Travel; (3) Internal quality monitoring activities; (4) Staff supervision, training, or consultation; or (5) Services rendered by an individual supports planner or nurse monitor in excess of 7 hours per day unless pre-authorized by the Department in writing. #### Regulation .14 Payment Procedures. *COMAR 10.09.20.14* A. Request for Payment — Personal Assistance. To receive payment as a personal assistance provider agency under Regulation .09 of this chapter, a provider and its workers shall use the telephonic time-keeping system approved by the Department to: (1) Document time; and (2) Submit claims. B. Request for Payment — All Other Covered Services. To receive payment as a provider of services covered under Regulations .10 and .11 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department’s billing manual. C. Billing time limitations are set forth in COMAR 10.09.36.06. D. Payments. (1) Payments for services rendered to a participant shall be made directly to a qualified provider. (2) A provider shall be paid the lesser of: (a) The provider’s usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rate established according to the fee schedule published by the Department. E. Effective July 1, 2018, for personal assistance services up to 12 hours per day, payment will be made in 15-minute units of service. For individuals who are determined to need more than 12 hours of personal assistance per day, a daily rate for the service will be paid. F. Rates. (1) The Department shall publish a fee schedule for services covered under this chapter which shall be publicly available and updated at least annually or upon any changes made by the Department. (2) Effective July 1, 2018, the Program’s rates as specified in the Department’s fee schedule shall increase on July 1 of each year by 3 percent, subject to the limitations of the State budget. #### Regulation .15 Recovery and Reimbursement. *COMAR 10.09.20.15* Recovery and reimbursement procedures shall be as set forth in COMAR 10.09.36.07. #### Regulation .16 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.20.16* Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .17 Appeal Procedures — Providers. *COMAR 10.09.20.17* Appeal procedures shall be as set forth in: A. COMAR 10.09.36.09; and B. COMAR 10.01.03. #### Regulation .18 Appeal Procedures — Applicants and Participants. *COMAR 10.09.20.18* Appeal procedures for applicants and participants are those set forth in: A. COMAR 10.09.24.13; and B. COMAR 10.01.04. #### Regulation .19 Interpretive Regulation. *COMAR 10.09.20.19* Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. #### Regulation .20 Implementation Date. *COMAR 10.09.20.20* This chapter shall be implemented October 1, 2015. ### Chapter 21 — Pharmacists **Authority:** Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-148(c), Annotated Code of Maryland **Administrative History:** Effective date: December 31, 2018 (45:26 Md. R. 1242) **Administrative History:** Regulation .02B amended effective May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187) **Administrative History:** Regulation .03 amended effective January 6, 2025 (51:26 Md. R. 1187) **Administrative History:** Regulation .03C, D adopted effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187) **Administrative History:** Regulation .05 amended effective January 6, 2025 (51:26 Md. R. 1187) **Administrative History:** Regulation .06 amended effective June 14, 2021 (48:12 Md. R. 473); May 1, 2023 (50:8 Md. R. 337); January 6, 2025 (51:26 Md. R. 1187) #### Regulation .01 Purpose and Scope. *COMAR 10.09.21.01* This chapter establishes requirements for individual pharmacists who enroll in the Program. #### Regulation .02 Definitions. *COMAR 10.09.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland Board of Pharmacy. (2) “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. (3) “Medication therapy management” services are defined as face-to-face consultations that are structured to reduce the risk of adverse events and ensure optimum therapeutic outcomes for targeted patients through improved medication use with disease-state specific education, counseling, and medication review related to treatments, including drug therapy, laboratory tests, or medical devices provided by licensed and practicing pharmacists. (4) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (5) “Pharmacist” means an individual licensed in good standing to practice pharmacy in the state where the service is provided. (6) “Program” means the Maryland Medical Assistance Program. #### Regulation .03 Provider Qualifications and Conditions for Participation. *COMAR 10.09.21.03* The pharmacist shall meet: A. Licensure requirements set forth in COMAR 10.09.36.02; B. Conditions for participation set forth in COMAR 10.09.36.03; and C. Conditions for their license under the Board of Pharmacy as stated in Health Occupations Article, Title 12, Subtitle 3, Annotated Code of Maryland. #### Regulation .04 Covered Services. *COMAR 10.09.21.04* The Program covers the following medically necessary services when rendered by a pharmacist: A. Services rendered within the pharmacist’s lawful scope of practice as defined by the Board and otherwise covered by the Program in accordance with COMAR 10.09.02.07D; and B. Medication therapy management for participants who meet the Department’s clinical criteria. #### Regulation .05 Limitations. *COMAR 10.09.21.05* The following are not covered: A. Pharmacist administered drugs obtained from manufacturers who do not participate in the federal Drug Rebate Program; B. Medical supplies usually included in an office visit; C. Services not medically necessary; D. Investigational and experimental drugs and procedures; E. Procedures solely for cosmetic purposes; and F. Services denied by Medicare as not medically justified. #### Regulation .06 Payment Procedures. *COMAR 10.09.21.06* A. The provider shall adhere to general provider payment procedures established in COMAR 10.09.36.04. B. The provider shall be reimbursed in accordance with COMAR 10.09.02.07D. C. Effective January 1, 2024, medication therapy management shall be reimbursed at the following rates: (1) For the first 8—15 minutes: (a) For new patients, $49.67 per unit of service; or (b) For established patients, $31.24 per unit of service; and (2) For each additional 8—15 minute, $24.54 per unit of service. D. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.21.07* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.21.08* Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. ### Chapter 22 — Free-Standing Dialysis Facility Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: December 2, 1985 (12:24 Md. R. 2348) **Administrative History:** Regulation .01B amended effective February 17, 2014 (41:3 Md. R. 201) **Administrative History:** Regulations .02 and .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .03B amended effective February 17, 2014 (41:3 Md. R. 201) **Administrative History:** Regulation .04B amended effective February 17, 2014 (41:3 Md. R. 201) **Administrative History:** Regulation .05 amended effective February 17, 2014 (41:3 Md. R. 201) **Administrative History:** Regulation .07 amended effective February 17, 2014 (41:3 Md. R. 201) **Administrative History:** Regulation .07G amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07J amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07J amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .09C adopted effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Chapter revised effective March 26, 2018 (45:6 Md. R. 319) #### Regulation .01 Definitions. *COMAR 10.09.22.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “CMS” means Centers for Medicare and Medicaid Services. (2) “Continuous ambulatory peritoneal dialysis (CAPD)” means a dialysis treatment method performed manually during the day by patient in which the patient’s peritoneal membrane is used as a dialyzer. (3) “Continuous cycling peritoneal dialysis (CCPD)” means a dialysis treatment method performed automatically during the night with a peritoneal dialysis cycler in which the patient’s peritoneal membrane is used as a dialyzer. (4) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Dialysis” means a treatment method in which waste products are removed from the body by diffusion from one fluid compartment to another across a semi-permeable membrane. (6) “Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Board of Dietetic Practice to practice dietetics in Maryland. (7) “Free-standing dialysis facility” means a dialysis unit capable of providing staff-assisted dialysis, which is not located in an acute hospital setting. (8) “Hemodialysis” means a dialysis treatment method in which blood passes through an artificial kidney machine and the waste products diffuse across a manmade membrane into a bath solution known as dialysate after which the cleansed blood is returned to the patient’s body. (9) “Home dialysis” means hemodialysis or peritoneal dialysis performed regularly in the home with the assistance of a family member or the patient’s caregiver. (10) "Home dialysis training” means instructions on how to perform dialysis services in a home setting. (11) “Licensed practical nurse (LPN)” means an individual licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. (12) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (13) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family or provider. (14) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (15) “Nurse practitioner” means an individual who is licensed and certified to practice as a nurse practitioner as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. (16) “Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. (17) “Patient care policies” means written policies and protocols describing patient care practices and procedures established by a group of professional personnel (including one or more physicians affiliated with the free-standing dialysis facility) and approved in writing by the facility's medical director. (18) “Peritoneal dialysis” means a dialysis treatment method in which waste products pass from the patient’s body through the peritoneal membrane into the peritoneal cavity where the bath solution (dialysate) is introduced and removed periodically. (19) “Physician” means an individual who is authorized under the Maryland Medical Practice Act to practice medicine in this State as stated in Health-General Article §1-101, Annotated Code of Maryland. (20) “Physician assistant” means an individual who is licensed to practice medicine with physician supervision as stated in Health Occupations Article, §§15-301(d) and (e) and 15-302, Annotated Code of Maryland. (21) “Plan of care” means a written plan for evaluation, treatment, and follow-up of each participant documented in the participant’s medical record that should include, at a minimum, the following information: (a) Patient identification data; (b) Date of service; (c) Reason for visit; (d) Medical history; (e) Plan for treatment; (f) Results of all laboratory tests ordered and performed; and (g) Interpretation of all diagnostic radiology procedures ordered and performed. (22) “Program” means the Maryland Medical Assistance Program. (23) “Registered nurse (RN)” means an individual licensed to practice registered nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. (24) “Social worker” means a person who is licensed as a social worker in accordance with COMAR 10.42.01.05. #### Regulation .02 License Requirements. *COMAR 10.09.22.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. A physician providing services in a free-standing dialysis facility shall be licensed and legally authorized to practice medicine in the state in which the service is provided. C. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02, or other applicable standards established by the state in which the service is provided. D. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or COMAR 10.10.06, as applicable; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.22.03* A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. Specific requirements for participation in the Program as a free-standing dialysis facility include all of the following: (1) Be approved by Medicare to furnish dialysis service to kidney disease patients and maintain documentation of certification by the Division of Survey and Certification of CMS. (2) Verify the licenses and credentials of all professionals employed by, or under contract with, the free-standing dialysis facility to provide services. (3) Meet the requirements of COMAR 10.30.01.05C, for a dialysis facility, home dialysis unit, or self-care dialysis facility, or all of the above. (4) Have clearly defined, written, patient care policies. (5) Maintain adequate documentation of each participant visit, as part of the plan of care, which, at a minimum, shall include: (a) Date of service; (b) Participant’s reason for visit; (c) A brief description of service provided; (d) A legible signature and printed or typed name of professional providing care, with the appropriate title. (6) Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01. (7) Maintain adequate administrative and medical records which are defined as having documentation sufficient in quantity, scope, and detail to confirm that the free-standing dialysis facility services are provided in accordance with this regulation. (8) Not employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Medical Assistance participants. (9) Be approved by the Medical Assistance Program in the state in which the service is provided. #### Regulation .04 Covered Services. *COMAR 10.09.22.04* A. The Program covers medically necessary services described in §B of this regulation, rendered to participants in a free-standing dialysis facility, when these services are: (1) Performed by a physician or by one of the following: (a) A physician assistant; (b) A nurse practitioner; (c) An RN; (d) An LPN; (e) A social worker; or (f) A dietitian-nutritionist; (2) Provided by a non-physician listed in §A(1) of this regulation, when the following conditions are met: (a) The individual performing the service is in the employ of, or under contract with, the free-standing dialysis facility; (b) The individual performing the service is under a physician's direct supervision or written direction; (c) The individual performs the service within the scope of the individual's license or certification for the purpose of assisting in the provision of the physician's services; and (d) The services are provided according to the free-standing dialysis facility physician's written plan of care; (3) Curative or rehabilitative services, when clearly related to the participant’s individual needs; (4) Adequately described in the participant’s medical record and consistent with the physician’s written plan of care. B. Covered services include: (1) Dialysis services furnished on an outpatient basis and provided by a free-standing dialysis facility, to include hemodialysis, peritoneal dialysis, CAPD, CCPD, and home dialysis training; and (2) Laboratory tests, supplies, and prescription drugs as related to dialysis services. #### Regulation .05 Limitations. *COMAR 10.09.22.05* The Program does not cover the following: A. Services not specified in Regulation .04 of this chapter; B. Services not medically necessary; C. Investigational and experimental drugs and procedures; D. Drugs and supplies which are acquired at no cost; E. Injections and visits solely for the administration of injections, unless both the participant’s inability to take oral medications and medical necessity for the injections are documented in the participant’s medical record; F. Travel expenses; G. Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service; H. Laboratory or X-ray services performed by another facility; I. Completion of forms and reports; J. Broken or missed appointments; and K. Professional services rendered by mail or telephone. #### Regulation .06 Payment Procedures. *COMAR 10.09.22.06* A. Reimbursement Principles. (1) Reimbursement by the Program is for services described in Regulation .04B of this chapter provided at a free-standing dialysis facility which has been approved for Medicare by the Division of Survey and Certification of CMS. (2) Reimbursement shall be consistent with the rates established by the Program for those services which are approved by Medicare. (3) Physician services are not reimbursed under this regulation. Reimbursement for physician services are in accordance with COMAR 10.09.02.07. B. The provider shall submit a request for payment on the form designated by the Department. C. The Program reserves the right to return to the provider, any invoice that is not properly completed. D. A provider shall bill the program the established Medicaid rate for dialysis services. E. Payments on Medicare claims are authorized if: (1) The provider accepts Medicare assignment; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that the services are medically necessary; (4) Services are covered by the program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. F. The Department will make supplemental payment on Medicare claims subject to the following provisions: (1) Deductible and coinsurance are to be paid in full; and (2) Services not covered by Medicare are payable according to §D of this regulation. G. The provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail or telephone; or (4) Home visits unless satisfactorily documented as an emergency. H. The Program will make no direct payment to a participant. I. The Program will make no separate direct payment to any person employed by or under contract to any free-standing dialysis facility for services covered under this regulation. J. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.22.07* A. If the participant has insurance or if any other person is obligated either legally or contractually to pay for, or to reimburse for, any service covered by this chapter, the provider shall seek payment from that source. If payment is made by both the Program and by the insurace or other source, the provider shall refund the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.22.08* A. If the Department determines that a provider, any agent or employee of a provider, or any person with an ownership interest in the provider, has failed to comply with all applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Recovery of overpayments as specified in Regulation .07 of this chapter; (2) Withholding part or all of the payment by the Program; (3) Suspension from the Program; (4) Permanent removal from the Program; (5) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes the provider from participation in Medicare, the Department will take similar action. C. The Department shall give to the provider reasonable written notice of its intention to impose sanctions. In the notice, the Department shall: (1) Establish the: (a) Effective date of the proposed action; and (b) Reasons for the proposed action; and (2) Advise the provider of the right to appeal. #### Regulation .09 Appeal Procedures. *COMAR 10.09.22.09* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.22.10* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services which are provided without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 23 — Early and Periodic Screening, Diagnosis and Treatment (EPSDT) Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1983 (9:25 Md. R. 2483) **Administrative History:** Regulation .01 amended effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .01B amended effective March 12, 1984 (11:5 Md. R. 463); October 1, 1985 (12:19 Md. R. 1849) **Administrative History:** Regulation .04A amended effective September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .04B amended effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .05 amended effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .05B amended as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); amended permanently effective May 1, 1983 (10:7 Md. R. 634) **Administrative History:** Regulation .06 amended effective October 1, 1985 (12:19 Md. R. 1849); March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .06A amended effective October 29, 1984 (11:21 Md. R. 1814) **Administrative History:** Regulation .07 amended effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .07A-1 adopted effective February 13, 1984 (11:3 Md. R. 200) **Administrative History:** Regulation .07D amended effective October 1, 1985 (12:19 Md. R. 1849) **Administrative History:** Regulation .08 amended effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Regulation .08F amended and .08G-1 adopted effective September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .08F amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulations .08F, J and .09A amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); Regulation .08F, J amended permanently effective October 7, 1991 (18:18 Md. R. 2004) (Regulation .09A not amended permanently at this time—emergency status expired October 6, 1991) **Administrative History:** Regulation .08I amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1850); amended permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulation .08J amended effective May 1, 1983 (10:8 Md. R. 725); February 13, 1984 (11:3 Md. R. 200); October 29, 1984 (11:21 Md. R. 1814); October 1, 1985 (12:19 Md. R. 1849) **Administrative History:** Regulation .08J amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1170); emergency status expired October 28, 1984 **Administrative History:** Regulation .08J amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); adopted permanently effective February 9, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .08L amended effective October 29, 1984 (11:21 Md. R. 1814) **Administrative History:** Regulation .09A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Regulation .11 amended effective June 6, 1983 (10:11 Md. R. 974); March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Table 1 amended effective February 13, 1984 (11:3 Md. R. 200); June 3, 1985 (12:11 Md. R. 1049) **Administrative History:** Table 2A adopted as an emergency provision effective January 1, 1983 (10:1 Md. R. 22); adopted permanently effective May 1, 1983 (10:7 Md. R. 634) **Administrative History:** Tables 1, 2, and 2A repealed effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Table 3 recodified as Table 1 effective March 20, 1989 (16:5 Md. R. 629) **Administrative History:** Chapter revised effective July 19, 1993 (20:14 Md. R. 1169) **Administrative History:** Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .07A amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .08 amended effective June 21, 2004 (31:12 Md. R. 911) **Administrative History:** Regulations .01—.13 repealed and new Regulations .01—.12 adopted effective March 22, 2010 (37:6 Md. R. 477) **Administrative History:** Regulation .01B amended effective August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .01-1 adopted effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .01-1 amended effective December 31, 2018 (45:26 Md. R. 1243); August 26, 2019 (46:17 Md. R. 726); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .02B, E amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .02E amended effective December 27, 2010 (37:26 Md. R. 1787); August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .02F adopted effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .03A, B amended effective August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .03B amended effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .04D amended effective December 27, 2010 (37:26 Md. R. 1787); October 26, 2015 (42:21 Md. R. 1300); July 3, 2017 (44:13 Md. R. 621); December 31, 2018 (45:26 Md. R. 1243); August 7, 2023 (50:15 Md. R. 681); March 16, 2026 (53:5 Md. R. 243) **Administrative History:** Regulation .05B amended effective August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .05D amended effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .05E amended effective July 4, 2016 (43:13 Md. R. 712); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .06G adopted effective February 16, 2015 (42:3 Md. R. 315) **Administrative History:** Regulation .06G amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .07C amended effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .07C, E amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .07D amended effective September 30, 2013 (40:19 Md. R. 1544); February 1, 2016 (43:2 Md. R. 127); September 26, 2016 (43:19 Md. R. 1072); August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .08A amended effective August 7, 2023 (50:15 Md. R. 681) **Administrative History:** Regulation .12 repealed effective October 27, 2014 (41:21 Md. R. 1259) #### Regulation .01 Definitions. *COMAR 10.09.23.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “American Academy of Pediatric Dentists” means the membership organization representing the specialty of pediatric dentistry. (2) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program or its designee. (3) “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means comprehensive and preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other diagnostic and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses in children younger than 21 years old. (4) “EPSDT periodicity schedule” means the State-specified listing of the minimum required and recommended preventive health screening services that are to be performed at specified ages. (5) “EPSDT screen” means the full scope of comprehensive well-child screening procedures, required by the State periodicity schedule that a participant receives at a given age. (6) “EPSDT screening provider” means a physician, nurse practitioner, or physician assistant certified by the Department to provide EPSDT screens. (7) “EPSDT treatment provider” means a health care provider that is enrolled to provide services that are not otherwise covered for individuals 21 years old or older. (8) “EPSDT treatment services” means health care services that are covered for children younger than 21 years old that are not otherwise covered for individuals 21 years old or older. (9) “Environmental lead investigation” means an inspection of the primary dwelling of a participant that results in a report characterizing the hazards associated with identified lead-containing substances. (10) Foster Care Child. (a) “Foster care child” means a participant who is in the care and custody of the Department of Human Services. (b) “Foster care child” includes children who receive kinship care. (11) “Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, or under the laws of the District of Columbia or another state, to provide health care services. (12) “Health care service” has the meaning stated in Health-General Article, §19-132, Annotated Code of Maryland. (13) “Healthy Kids Program” means the unit within the Maryland Medical Assistance Program that develops guidelines for and monitors EPSDT well-child screening services and certifies EPSDT screening providers. (14) “Intermediate care facility” means a facility that provides a planned regimen of 24-hour professionally directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting. (15) “Jurisdiction” means a state or the District of Columbia. (16) “Managed Care Organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. (17) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (18) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (19) “Participant” means a person younger than 21 years old who is determined eligible for, and is receiving, Medical Assistance benefits as provided in COMAR 10.09.11 or 10.09.24. (20) “Plan of treatment” means a written plan, updated at a minimum of every 6 months for ongoing care, to address identified problems to include: (a) Diagnoses; (b) Treatment goals; (c) Frequency of visits; (d) Duration of treatment; and (e) Prognosis. (21) “Preauthorization” means the approval required from the Department or its designee before services can be rendered. (22) “Preventive services” means primary health care designed to: (a) Promote normal growth and development; and (b) Detect, ameliorate, or delay diseases at an early stage before complications or serious disabilities develop. (23) “Program” means the Maryland Medical Assistance Program. (24) “Screening services” means the EPSDT preventive health care and laboratory procedures required at specified ages by the State periodicity schedule. (25) “Third-party payers” means insurers and other entities obligated either legally or contractually to pay for or to reimburse the participant for service covered in this chapter. (26) “Vaccines for Children Program” means the federal program that provides specific childhood vaccines to health care providers, at no cost, for administration to participants younger than 19 years old. #### Regulation .01-1 Incorporation by Reference. *COMAR 10.09.23.01-1* The Audiology, Physical Therapy, and Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual (Maryland Medical Assistance Program, Effective January 1, 2022) is incorporated by reference. #### Regulation .02 Provider Qualifications. *COMAR 10.09.23.02* A. EPSDT screening and treatment providers shall meet all of the licensure and certification requirements specified in this or any other applicable chapter of COMAR, statute, or policy for the service that the provider renders. B. In order for the Program to consider a health care practitioner for certification by the Healthy Kids Program as an EPSDT screening provider, the practitioner shall have a demonstrated history of providing services to children younger than 21 years old and shall also: (1) Be a doctor of medicine or osteopathy who is: (a) Licensed in good standing and legally authorized to practice medicine and surgery in the jurisdiction in which the service is provided; and (b) Board-certified in one of the following: (i) Pediatrics; (ii) Family practice; or (iii) Internal medicine; or (2) Be a pediatric or family nurse practitioner or a physician assistant who is licensed in good standing and certified to practice in the jurisdiction in which services are provided. C. A freestanding clinic as defined in COMAR 10.09.08 shall be considered for certification by the Healthy Kids Program as an EPSDT screening provider if the clinic employs or contracts with one or more of the licensed health care practitioners listed in §B of this regulation. D. Any health care practitioner whose professional services are recognized in §1905(a) of the Social Security Act may apply to the Program to be an EPSDT treatment provider. E. EPSDT treatment providers that are covered by the Program include: (1) The following provider types that are licensed in good standing to practice in the jurisdiction in which services are provided: (a) Chiropractors; (b) Nurse psychotherapists; (c) Nutritionists or dietitians; (d) Occupational therapists; (e) Professional counselors; (f) Psychologists; (g) Social workers; (h) Speech therapists; or (i) An intermediate care facility that provides at least one of the following: (i) Clinically managed high intensity residential treatment; and (ii) Medically monitored intensive inpatient treatment; (2) Lead paint risk assessors who are accredited by the Maryland Department of the Environment in accordance with COMAR 26.16.01.16; (3) Audiologists and hearing aid providers, as specified in COMAR 10.09.51.02; (4) Dentists as specified in COMAR 10.09.05.02; (5) Private duty nurses, as specified in COMAR 10.09.53.02; (6) Residential treatment centers, as specified in COMAR 10.09.29.02; (7) Therapeutic behavioral service providers, as specified in COMAR 10.09.34.02; and (8) Vision care and optical providers, as specified in COMAR 10.09.14.02. (9) Therapeutic nursery service providers, as specified in COMAR 10.21.18.03. F. In order to qualify as an EPSDT treatment provider, an intermediate care facility shall: (1) Be licensed under COMAR 10.63.03 or certified under COMAR 10.47.02, whichever is appropriate; and (2) If appropriate, provide separate social, residential, dietary, and recreational activities for children and adolescents. #### Regulation .03 Conditions for Participation. *COMAR 10.09.23.03* A. In order to receive payments as a Medicaid provider, providers shall meet the following general requirements: (1) All conditions for participation set forth in COMAR 10.09.36; (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department; (3) The licensure and provider qualification requirements in Regulation .02 of this chapter; and (4) Verify the licenses and credentials of all professionals employed or contracted by the provider, and keep on file documentation of how that verification was completed. B. To be certified to participate in the Healthy Kids Program as an EPSDT screening provider, a provider shall agree to: (1) Provide EPSDT comprehensive well-child services as outlined in the EPSDT periodicity schedule and in a manner prescribed by the Department; (2) Provide or arrange for referral, diagnosis, treatment, and follow-up when the screening indicates a need for additional services; (3) Inform the parent or guardian of the next preventive health care visit, and assist with scheduling; (4) Cooperate with Departmental efforts to assure that children receive needed follow-up and treatment services; (5) Conform to the equipment, facilities, and procedural standards set by the Department; (6) Maintain a patient record system that is sufficiently detailed and current to allow another physician who is unfamiliar with the patient to properly continue treatment in the absence of the initial provider; (7) Participate in the Vaccines for Children Program; (8) Permit periodic on-site quality assurance visits by the Department or its designee following a protocol established by the Department to: (a) Assure that the equipment necessary to perform required procedures is available; (b) Review the charts of participants to assure delivery of EPSDT screens; (c) Determine that required procedures are being performed correctly and that appropriate follow-up is provided; and (d) Assess the need for any follow-up provider training, staff training, technical assistance, or in-service training; and (9) Maintain a minimum score of 80 percent on all Healthy Kids Program quality assurance reviews. C. An MCO that has contracted with the Department shall ensure its enrollees have access to EPSDT comprehensive well-child services in accordance with COMAR 10.67.05.05A(3). #### Regulation .04 Covered Services. *COMAR 10.09.23.04* A. The Program covers all medically necessary care, including all health care services to identify and correct physical and mental problems that are covered in the State Plan, or that are allowable under the federal Medicaid program as described in §1905(a) of the Social Security Act. B. For a foster care child, the Program also covers upon entry to or moving within the foster care system: (1) A brief initial check-up; and (2) A comprehensive EPSDT screen as described in §C of this regulation. C. The Program covers EPSDT comprehensive well-child services in accordance with the EPSDT periodicity schedule, which includes the following: (1) EPSDT screening services which comprise the following: (a) A comprehensive health and developmental history, including assessment of both physical and mental health and development; (b) Age-appropriate immunizations; (c) Age and risk appropriate laboratory tests, including blood lead levels that are required at specific ages regardless of risk; (d) Comprehensive unclothed physical examination; and (e) Health education and anticipatory guidance; (2) Vision services that comprise: (a) Vision screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule; (b) Vision screening and vision services delivered by optometrists and opticians, including eyeglasses, as described in COMAR 10.09.14.04; (3) Hearing services that comprise: (a) Hearing screening delivered by the EPSDT screening provider according to the EPSDT periodicity schedule; and (b) Hearing screening and hearing aid services, as described in COMAR 10.09.51.04; and (4) Dental services, including: (a) Oral health assessment by the EPSDT screening provider and referral to a dentist; and (b) Dental services, as specified in COMAR 10.09.05.04. D. Additional Medically Necessary Plan of Treatment Services. (1) The Program also covers the EPSDT treatment services listed in §D(2) of this regulation when the services are: (a) Necessary to identify, correct, or ameliorate defects and physical and mental illnesses and conditions; (b) Rendered in accordance with accepted professional standards; and (c) Delivered in accordance with a plan of treatment. (2) EPSDT services covered under §D of this regulation include: (a) Chiropractic services; (b) Mental health services or behavioral health services, or both, when the diagnosis of a participant is not included under the specialty mental health system, as described in COMAR 10.67.08.02; (c) Nutritional counseling services; (d) Occupational therapy services; (e) Speech therapy services; (f) Medically monitored intensive inpatient treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.14, whichever is applicable; (g) Clinically managed high intensity residential treatment services provided in an intermediate care facility, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable; (h) Environmental lead investigations, as specified in COMAR 26.16.02.04 and .05 when there is a confirmed elevated blood lead level of the lower of the following values: (i) 3.5 micrograms or greater per deciliter, the current Maryland elevated blood lead level; or (ii) The Centers for Disease Control and Prevention blood lead reference value; (i) Private duty nursing services, as specified in COMAR 10.09.53.04; (j) Residential treatment services, as specified in COMAR 10.09.29.04; and (k) Therapeutic behavioral services, as specified in COMAR 10.09.34.03. #### Regulation .05 Limitations. *COMAR 10.09.23.05* A. Any Program limits on services or treatments identified in this regulation are not applicable for individuals younger than 21 years old if it is shown that the treatments or services are medically necessary to correct or ameliorate identified or suspected health problems. B. The dental covered services specified in COMAR 10.09.05.04, which follow the periodicity schedule issued by the American Academy of Pediatric Dentists, are limited to two dental examinations per participant per 12-month period. C. Vision services specified in COMAR 10.09.14.04, including eye examinations and eyeglasses or contact lenses, are limited to not more than once a year. D. Environmental lead investigations: (1) Are limited to the child's primary dwelling; (2) Are limited to one on-site inspection per dwelling; and (3) Do not include testing of any substances sent to a laboratory for analysis. E. The provider covered by this chapter may not bill the Program for: (1) Services that are: (a) Provided while the participant is in an institution for mental disease, a hospital, or a residential treatment center, as bundled payment for institutional stays includes EPSDT services; (b) Custodial or assist with activities of daily living; (c) Not medically necessary; (d) Beyond the provider's scope of practice; (e) Rendered but not appropriately documented; (f) Part of another service paid for by the State; or (g) Rendered not in person, unless the services are provided in compliance with COMAR 10.09.49 and any subregulatory guidance issued by the Department; (2) Respite services; (3) Completion of forms or reports; (4) Broken or missed appointments; (5) Supplies, equipment, or items that are not medical in nature; or (6) Services that are primarily cosmetic in nature. #### Regulation .06 Preauthorization. *COMAR 10.09.23.06* Preauthorization is required for: A. Certain audiology and hearing aid services, as specified in COMAR 10.09.51.06; B. Certain dental services, as specified in COMAR 10.09.05.06; C. Certain vision services, as specified in COMAR 10.09.14.06; D. Private duty nursing services, as specified in COMAR 10.09.53.06; E. Residential treatment services, as specified in COMAR 10.09.29.06; F. Therapeutic behavioral services, as specified in COMAR 10.09.34.05; and G. Intermediate Care Facilities, as specified in COMAR 10.47.02.09 or COMAR 10.63.03.13, whichever is applicable. #### Regulation .07 Payment Procedures. *COMAR 10.09.23.07* A. Request for payment of services shall be submitted in accordance with COMAR 10.09.36.04. B. Billing time limitations for claims submitted pursuant to this chapter as set forth in COMAR 10.09.36.06. C. Rates for services provided by chiropractors, speech therapists, occupational therapists, and nutritionists covered under this chapter are included in the Early Periodic, Screening, Diagnosis, and Treatment (EPSDT) Provider Manual. D. Reimbursement of Medically Monitored Intensive Inpatient Treatment Services Provided in an Intermediate Care Facility. (1) The Department may not directly reimburse any State-operated intermediate care facility for participants. The Department shall claim federal fund recoveries from the Department of Health and Human Services for services to federally eligible Title XIX patients in these intermediate care facilities. (2) The Department shall pay the intermediate care facility the lesser of: (a) The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or (b) The provider’s per diem costs for covered services according to the principles established under Title XVIII of the Social Security Act, up to a maximum of $400 per day. (3) The maximum payment in §D(2)(b) of this regulation will be updated annually by the Centers for Medicare and Medicaid Service’s published federal fiscal year market basket increase percentage relating to hospitals excluded from the prospective payment system. (4) Submitting Cost Reports. (a) Facilities reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413.40, as amended, shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. If reports are not received within 3 months and the Department has not granted an extension, the Department shall withhold from the provider a maximum of 10 percent of the current interim payment for the calendar month in which the report is due and any subsequent calendar month until the report has been submitted. There may not be a refund or adjustment for withholding in cost settlement. (b) If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. (c) The Department may grant an extension if: (i) The provider makes a written request setting forth the specific reasons for the request; and (ii) The Department determines, taking into consideration the totality of the circumstances, that the request is reasonable. (d) If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, and the provider has not received an extension, the Department, in addition to withholding percentages of payment pursuant to §D(3)(a) of this regulation, may impose one or more sanctions as provided for in Regulation .09 of this chapter. (e) If a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department, if applicable, shall make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established may not exceed the maximum per diem rates in effect when the facility's costs were last settled. (f) For purposes of §D(3)(a)—(e) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department. (5) Participant’s Contribution. (a) The local department of social services or the State-operated facility’s fiscal agent shall determine the amount the participant has available to pay toward the cost of medical or remedial care for inpatient services, and so inform the provider. (b) The provider shall collect from the participant that amount as shown available on the designated form. (c) The provider may not collect a total amount, including the participant’s resource and the Department’s payment, which exceeds the provider’s rate established by the Department. (d) The provider shall show to the Department sums collected from the participant. E. Reimbursement for environmental lead investigation is $333.29 per inspection. F. Reimbursement for services covered in Regulation .04 of this chapter shall be the lower of the provider's charge for the service, or the Program's fee schedule. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.23.08* A. Regardless of whether the participant has other third-party insurance coverage, EPSDT screening providers shall bill the Program directly for the following components of an EPSDT screen: (1) Comprehensive unclothed physical examinations; (2) Immunizations when the vaccine is not covered by the Vaccines for Children Program; (3) Vaccine administration; and (4) Objective screenings for: (a) Developmental assessment; (b) Hearing; and (c) Vision. B. Upon submission of a claim for a EPSDT screening component, as described in §A of this regulation, the Department shall pursue third-party reimbursement when appropriate. C. Recovery and reimbursement for all other services in the chapter are set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.23.09* A. Cause for suspension or removal and impositions of sanctions are as set forth in COMAR 10.09.36.08. B. If during a quality assessment, the Department staff determines that the provider does not meet the standards established by the Department, the Department may decertify the provider as an EPSDT screening provider. #### Regulation .10 Appeal Procedures. *COMAR 10.09.23.10* Appeal procedures are as set forth in COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulations. *COMAR 10.09.23.11* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 24 — Medical Assistance Eligibility **Authority:** Estates and Trusts Article, §14.5-1002; Health-General Article, §§2-104(b), 2-105(b), 15-103, 15-105, 15-121, and 15-401—15-407; Annotated Code of Maryland; Annotated Code of Maryland **Administrative History:** Effective date: May 1, 1983 (10:6 Md. R. 558) **Administrative History:** Regulations .01, .02, and .06 amended as an emergency provision effective December 1, 1992 (19:25 Md. R. 2198); amended permanently effective June 1, 1993 (20:10 Md. R. 852) **Administrative History:** Regulation .02B amended effective May 1, 1986 (13:8 Md. R. 898); August 8, 1988 (15:16 Md. R. 1914); May 1, 1989 (16:8 Md. R. 910); December 1, 1992 (19:23 Md. R. 2041); March 24, 1997 (24:6 Md. R. 485); June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulations .02B; .03C; .04; .07B, I, J, L; .08G, H; .09B; .10C, E, F; .11D, E; .12B; .14A; and .15D amended as an emergency provision effective May 1, 1983 (10:11 Md. R. 962); adopted permanently effective September 1, 1983 (10:17 Md. R. 1521) **Administrative History:** Regulations .02B and .05A amended as an emergency provision effective October 3, 1997 (24:22 Md. R. 1550); amended permanently effective January 12, 1998 (25:1 Md. R. 16) **Administrative History:** Regulation .02B amended effective November 24, 2005 (32:23 Md. R. 1826); December 31, 2007 (34:26 Md. R. 2262); October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .03 amended as an emergency provision effective May 4, 1990 (17:11 Md. R. 1339); amended permanently effective August 13, 1990 (17:15 Md. R. 1858) **Administrative History:** Regulation .03-1 adopted effective April 1, 2002 (29:6 Md. R. 567) **Administrative History:** Regulation .03-1B amended effective June 9, 2003 (30:11 Md. R. 735) **Administrative History:** Regulation .03-2 adopted effective April 1, 2002 (29:6 Md. R. 567) **Administrative History:** Regulation .03-2F amended effective January 6, 2003 (29:26 Md. R. 2027) **Administrative History:** Regulation .03-3 adopted effective June 7, 2004 (31:11 Md. R. 856) **Administrative History:** Regulation .03-3 amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .03-4 adopted effective June 7, 2004 (31:11 Md. R. 856) **Administrative History:** Regulation .03-4A amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .04 amended effective May 1, 1986 (13:8 Md. R. 898); May 1, 1989 (16:8 Md. R. 910); June 30, 2008 (35:13 Md. R. 1179); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .04J amended as an emergency provision effective October 1, 2001 (28:24 Md. R. 2125); emergency status expired March 29, 2002 **Administrative History:** Regulations .04J, .07B, G—N, and .08B, G—L amended as an emergency provision effective March 1, 1984 (11:5 Md. R. 449); emergency status extended at 11:14 Md. R. 1247 (July 6, 1984) **Administrative History:** Regulations .04J, .07B, G—N, and .08B, G—L amended effective October 15, 1984 (11:20 Md. R. 1742) **Administrative History:** Regulation .04J amended effective September 20, 2010 (37:19 Md. R. 1284) **Administrative History:** Regulation .05 repealed and new Regulation .05 adopted effective September 24, 2007 (34:20 Md. R. 1737) **Administrative History:** Regulation .05A amended effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .05C amended effective April 19, 2010 (37:8 Md. R. 614) **Administrative History:** Regulation .05D amended effective March 11, 1985 (12:5 Md. R. 482); April 19, 2010 (37:8 Md. R. 614) **Administrative History:** Regulation .05E amended effective March 11, 1985 (12:5 Md. R. 482); March 24, 1997 (24:6 Md. R. 485) **Administrative History:** Regulation .05H amended effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .05-1 adopted effective September 24, 2007 (34:20 Md. R. 1737) **Administrative History:** Regulation .05-1B amended effective April 19, 2010 (37:8 Md. R. 614) **Administrative History:** Regulation .05-2 adopted effective September 24, 2007 (34:20 Md. R. 1737) **Administrative History:** Regulation .05-2 amended effective April 19, 2010 (37:8 Md. R. 614) **Administrative History:** Regulation .05-3 adopted effective September 24, 2007 (34:20 Md. R. 1737) **Administrative History:** Regulation .05-3K amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .05-4 adopted effective September 24, 2007 (34:20 Md. R. 1737) **Administrative History:** Regulation .05-5 adopted effective September 24, 2007 (34:20 Md. R. 1737) **Administrative History:** Regulations .06, .07M, .08, .10, .11, .12C, and .15 amended effective May 1, 1986 (13:8 Md. R. 898) **Administrative History:** Regulation .07 amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .07D, M amended effective June 30, 2008 (35:13 Md. R. 1179) **Administrative History:** Regulation .07J amended effective October 8, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .07M amended as an emergency provision effective September 30, 1989 (16:21 Md. R. 2258); adopted permanently effective February 1, 1990 (17:1 Md. R. 69) **Administrative History:** Regulation .07N amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1173); amended permanently effective September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .07N amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1628); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020) **Administrative History:** Regulation .07N amended effective August 10, 1987 (14:16 Md. R. 1774); July 1, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulations .07N and .10E amended as an emergency provision effective July 1, 1985 (12:13 Md. R. 1274); adopted permanently effective November 4, 1985 (12:22 Md. R. 2104) **Administrative History:** Regulation .07N amended as an emergency provision effective July 1, 1989 (16:14 Md. R. 1565); amended permanently effective October 30, 1989 (16:21 Md. R. 2261) **Administrative History:** Regulation .07N amended as an emergency provision effective July 1, 1990 (17:15 Md. R. 1851); adopted permanently effective November 1, 1990 (17:20 Md. R. 2427) **Administrative History:** Regulation .07N amended as an emergency provision effective December 10, 1991 (18:26 Md. R. 2827); amended permanently effective April 1, 1992 (19:5 Md. R. 577) **Administrative History:** Regulation .07N amended as an emergency provision effective November 25, 1992 (19:25 Md. R. 2199); amended permanently effective March 29, 1993 (20:4 Md. R. 371) **Administrative History:** Regulation .07N amended as an emergency provision effective July 22, 1993 (20:16 Md. R. 1275); amended permanently effective November 1, 1993 (20:21 Md. R. 1654) **Administrative History:** Regulation .07N amended as an emergency provision effective August 10, 1994 (21:18 Md. R. 1506); amended permanently effective November 7, 1994 (21:22 Md. R. 1876) **Administrative History:** Regulation .08 amended as an emergency provision effective May 15, 1992 (19:11 Md. R. 1012); emergency status extended at 19:19 Md. R. 1702; amended permanently effective September 14, 1992 (19:18 Md. R. 1656) **Administrative History:** Regulation .08 amended as an emergency provision effective April 8, 1994 (21:9 Md. R. 744); emergency provision rescinded retroactively to April 8, 1994 (21:14 Md. R. 1226) **Administrative History:** Regulation .08 amended effective June 30, 2008 (35:13 Md. R. 1179) **Administrative History:** Regulation .08B amended effective September 1, 1993 (20:17 Md. R. 1346); January 12, 1987 (14:1 Md. R. 31); August 22, 1988 (15:17 Md. R. 2049); July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .08G, H amended effective June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .08G, H, and H-1 amended effective January 12, 1987 (14:1 Md. R. 31) **Administrative History:** Regulation .08G, H, and I amended effective August 22, 1988 (15:17 Md. R. 2049) **Administrative History:** Regulation .08G, H, and K amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .08G, I amended as an emergency provision effective October 1, 2001 (29:4 Md. R. 413); emergency status extended at 29:8 Md. R. 696; amended permanently effective April 29, 2002 (29:8 Md. R. 700) **Administrative History:** Regulation .08J-1 adopted effective September 1, 1993 (20:17 Md. R. 1346) **Administrative History:** Regulation .08J-1 amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .08L amended effective June 29, 1987 (14:13 Md. R. 1474); January 25, 1988 (15:2 Md. R. 121) **Administrative History:** Regulation .08L amended as an emergency provision effective July 1, 1989 (16:14 Md. R. 1565); amended permanently effective October 30, 1989 (16:21 Md. R. 2261) **Administrative History:** Regulation .08M amended effective June 29, 1987 (14:13 Md. R. 1474) **Administrative History:** Regulations .08 and .10 amended, and new Regulation .10-1 adopted as an emergency provision effective September 30, 1989 (16:21 Md. R. 2259); adopted permanently effective February 1, 1990 (17:1 Md. R. 69) (Regulation .10-1 originally adopted as Regulation .11) **Administrative History:** Regulations .08-1 and .08-2 adopted effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .08-2 amended effective April 29, 2002 (29:8 Md. R. 700) **Administrative History:** Regulation .08-3 adopted effective November 24, 2005 (32:23 Md. R. 1826) **Administrative History:** Regulation .09B, C amended effective September 20, 2010 (37:19 Md. R. 1284) **Administrative History:** Regulation .10 amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .10C and D amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1628); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020) **Administrative History:** Regulation .10C, D amended effective July 1, 1987 (14:13 Md. R. 1474) **Administrative History:** Regulation .10C, D amended as an emergency provision effective March 13, 2009 (36:8 Md. R. 591); emergency status expired July 30, 2009 **Administrative History:** Regulation .10C, D amended effective July 27, 2009 (36:15 Md. R. 1165); September 20, 2010 (37:19 Md. R. 1284); October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .10E amended as an emergency provision effective May 1, 1983 (10:7 Md. R. 632); adopted permanently effective May 9, 1983 (10:9 Md. R. 791) **Administrative History:** Regulation .10-1 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1382); amended permanently effective November 1, 1992 (19:21 Md. R. 1891) **Administrative History:** Regulation .10-1C amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .10-1C, E amended and G adopted effective November 12, 1990 (17:21 Md. R. 2529) **Administrative History:** Regulation .10-1D amended effective October 8, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .11C amended effective September 10, 1994 (11:8 Md. R. 1584) June 2, 1997 (24:11 Md. R. 793) **Administrative History:** Regulation .11E amended effective September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .12B amended effective August 8, 1988 (15:16 Md. R. 1914) **Administrative History:** Regulation .12C amended effective September 10, 1984 (11:18 Md. R. 1584) **Administrative History:** Regulation .13 repealed and new Regulation .13 adopted effective March 19, 2012 (39:5 Md. R. 382) **Administrative History:** Regulation .13C amended effective August 8, 1988 (15:16 Md. R. 1914) **Administrative History:** Regulation .14 amended effective August 8, 1988 (15:16 Md. R. 1914) **Administrative History:** Regulation .14 amended and recodified to Regulations .14 and .14-1 effective December 1, 1992 (19:23 Md. R. 2041) **Administrative History:** Regulation .14B amended as an emergency provision effective May 1, 1984 (11:10 Md. R. 858); emergency status expired August 28, 1984 **Administrative History:** Regulation .14B amended effective August 29, 1984 (11:17 Md. R. 1492) **Administrative History:** Regulation .15 amended effective August 8, 1988 (15:16 Md. R. 1914); July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .15 amended as an emergency provision effective October 13, 1992 (19:22 Md. R. 1979); amended permanently effective February 1, 1993 (20:2 Md. R. 113) **Administrative History:** Regulation .15 amended as an emergency provision effective April 8, 1994 (21:9 Md. R. 744); emergency provision rescinded retroactively to April 8, 1994 (21:14 Md. R. 1226) **Administrative History:** Regulation .15A-3 amended as an emergency provision effective November 12, 2002 (29:24 Md. R. 1915); amended permanently effective February 17, 2003 (30:3 Md. R. 179) **Administrative History:** Regulation .17 adopted effective December 31, 2007 (34:26 Md. R. 2262) **Administrative History:** Chapter revised effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .02B amended effective September 11, 2017 (44:18 Md. R. 866); May 20, 2019 (46:10 Md. R. 486); April 4, 2022 (49:7 Md. R. 465); April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .03A amended effective August 5, 2024 (51:15 Md. R. 706) **Administrative History:** Regulation .03A, C amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .03A, F amended effective April 4, 2022 (49:7 Md. R. 465) **Administrative History:** Regulation .03F adopted effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .03-1 amended effective July 21, 2025 (52:14 Md. R. 712) **Administrative History:** Regulation .04F amended effective March 28, 2016 (43:6 Md. R. 406) **Administrative History:** Regulation .04-1D amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .04-1M adopted effective May 7, 2018 (45:9 Md. R. 461) **Administrative History:** Regulation .05-4B amended effective July 4, 2016 (43:13 Md. R. 713) **Administrative History:** Regulation .07B, F amended effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .08-1B amended effective February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .08-2B, C amended effective April 10, 2017 (44:7 Md. R. 355); May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .08-2C amended effective August 29, 2016 (43:17 Md. R. 954) **Administrative History:** Regulation .08-4 adopted effective April 13, 2015 (42:7 Md. R. 568) **Administrative History:** Regulation .10C, D amended effective September 11, 2017 (44:18 Md. R. 866) **Administrative History:** Regulation .10-2 adopted effective April 13, 2015 (42:7 Md. R. 568) **Administrative History:** Regulation .12E adopted effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .15A-3 amended effective April 13, 2015 (42:7 Md. R. 568) #### Regulation .01 Purpose and Scope. *COMAR 10.09.24.01* A. This chapter governs the determination of eligibility for the Maryland Medical Assistance Program. B. Eligibility may be established for the following coverage groups: (1) The MAGI coverage groups whose income standard is based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014; and (2) The MAGI Exempt coverage groups whose income standard is based on Title XIX of the Social Security Act. #### Regulation .02 Definitions. *COMAR 10.09.24.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Aged” means a person who is 65 years old or older. (2) “Aid to the Permanently and Totally Disabled” means a former category of public assistance mandated under Title XIV of the Social Security Act, 42 U.S.C. §1351 et seq., and replaced by Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. (3) “Appeal” means a process by which an applicant, recipient, or representative obtains review of a decision, action, or inaction of the Department or the local department of social services. (4) “Applicant” means a person whose written application for Medical Assistance has been submitted to the local department of social services but has not received final action. This includes a person, who need not be alive at the time of application, whose application is submitted through a representative. (5) “Application” means the filing of a written and signed application form for Medical Assistance at the local department of social services or its designee. (6) “Application date” means the date on which a written, signed application is received by the local department of social services. (7) “Application form” means the form designated by the Department to be completed, signed, and submitted to the local department of social services, or a designee, as an official application for Medical Assistance. (8) “Assistance unit” means one person, or a group of persons whose eligibility for Medical Assistance benefits is determined in conjunction with each other. (9) “Blindness” means a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of no greater than 20 degrees. (10) Caretaker Relative. (a) “Caretaker relative” means a parent or other person related by blood, marriage, or adoption and living with and caring for an unmarried child younger than 21 years old who is deprived of parental support due to death, continued absence from the home, incapacitation of a parent, or unemployment of the principal wage earner parent. A parent whose absence is occasioned solely by reason of the performance of active duty in the uniformed service of the United States is not considered absent from the home. The following relatives and their spouses meet this definition: father, mother, brother, sister, stepfather, stepmother, stepbrother, stepsister, uncle, aunt, first cousin, nephew or niece, and persons of preceding generations as denoted by the prefix of grand, great, and great-great; persons who legally adopt a child or his parent as well as the natural and other legally adopted children of these persons; and other relatives of adoptive parents in accordance with State law. A caretaker relative retains his status as a caretaker relative when the only child or children in his custody receives SSI benefits. This is the only instance when a caretaker relative without children in an assistance unit qualifies as a caretaker relative. (b) “Continued absence from the home” means that the parent is out of the home, the nature of the absence either interrupts or terminates the parent's functioning as a provider of maintenance, physical care, or guidance for the child, and the known or indefinite duration of the absence precludes counting on the parent's performance of his function in planning for the present support or care of the child. (c) “Incapacitation” means that a parent has a mental or physical defect, illness, or impairment which eliminates the parent's ability to support or care for the child and is expected to last for a period of at least 30 days. (d) “Principal wage earner parent” means whichever parent, in a home in which both parents of a child are living, earned a greater amount of income in the period specified below: (i) For initial eligibility, the 24 months immediately preceding the month in which application is filed on the basis of the unemployment of a parent; (ii) For eligibility for each subsequent month of the certification period, the 24 months immediately preceding the current month. (e) Unemployed Parent. (i) “Unemployed parent” means the principal wage earner parent who: (aa) Has been unemployed for at least 30 days before the receipt of Medical Assistance; and (bb) Has not left a job or refused to seek or accept employment without good cause within 30 days of the date of application. (ii) The condition of unemployment is met when the parent is employed less than 100 hours per month; or is employed 100 hours or more per month, if the parent's work is intermittent and the excess hours are of a temporary nature, as evidenced by the fact that the work hours were under the standard for the two previous months and are expected to be under the standard during the next month. (10-1) “Carrier” means a: (a) Health insurer; (b) Non-profit health service plan; (c) Health maintenance organization; (d) Dental plan organization; and (e) Any other person included as a third party in Section 1902(a)(25)(A) of the Social Security Act, as amended by the Federal Deficit Reduction Act of 2005. (11) “Categorically needy” means aged, blind, or disabled persons, or families and children, who are otherwise eligible for Medical Assistance and who meet the financial eligibility requirements for FIP, SSI, or Optional State Supplement. (12) “Child” means an unmarried person younger than 21 years old. (13) “Chronic hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. (14) “Comprehensive care facility” means a nursing facility licensed as a comprehensive care facility pursuant to COMAR 10.07.02. (14-1) “Continuing care retirement community (CCRC)” means an entity that obtains certificate of registration issued by the Maryland Department of Aging in accordance with COMAR 32.02.01 and pursuant to its authority under Article 70B, Annotated Code of Maryland. (15) “Corrective Managed Care Program” means the program administered by the Division of Utilization and Eligibility Review of the Medical Care Compliance Administration which limits recipients who have abused or misused Medical Assistance benefits to access most covered services through a single primary medical provider and a single pharmacy. (16) “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program. (17) “Department of Human Services” means the department of State government which administers the FIP program. (18) “Determination” means a decision regarding an applicant's eligibility for Medical Assistance. (19) “Disabled” means the inability to perform any substantial gainful activity by reason of a medically determinable physical or mental impairment which can be expected to result in death, or which has lasted or can be expected to last for a continuous period of not less than 12 months. (20) “Eligibility technician” means an employee of the local department of social services responsible for determining eligibility of applicants and recipients. (20-1) “Emergency services” means services provided by a licensed medical practitioner after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in: (a) Placing health in jeopardy; (b) Serious impairment to bodily functions; (c) Serious dysfunction of any bodily organ or part; or (d) Development or continuance of severe pain. (20-2) “Entrance fee” means a sum of money or other consideration, other than a surcharge that: (a) Is paid by a resident to a CCRC initially or in deferred payments, pursuant to a written continuing care agreement between the CCRC and the resident, which governs the use, treatment, and refund of the entrance fee; (b) Assures a resident of continuing care in the CCRC facility for a term of more than 1 year or for life; and (c) Is at least three times the weighted average of the monthly cost of the periodic fees charged to independent living and assisted living units. (21) “Extended care facility” means a nursing facility licensed as an extended care facility pursuant to COMAR 10.07.02. (21-1) “Family Investment Program (FIP)” means a category of public assistance mandated under Title IV-A of the Social Security Act, 42 U.S.C. §601 et seq. (21-2) “Guardian of the person” means a guardian appointed by a court pursuant to Estates and Trusts Article, Title 13, Subtitle 7, Annotated Code of Maryland, to serve the interests of a minor or disabled person under that subtitle. (21-3) “Guardian of the property” means a guardian appointed by a court pursuant to Estates and Trusts Article, Title 13, Subtitle 2, Annotated Code of Maryland, to serve the interests of a minor or disabled person under that subtitle. (22) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or is licensed according to applicable standards established by the state in which the hospital is located. (23) Income. (a) “Income” means any property or service received by a person in cash or in-kind which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. (b) “Earned income” means payment received by a person in cash or in-kind as a result of employment, including self-employment. Earned income consists of wages, salaries, commissions, tips, and profit from self-employment. (c) “In-kind income” means support or benefits in the form of food or shelter, or both, received by a person. (d) “Unearned income” means all income which does not meet the definition of earned income. (24) “Family Investment Administration” means the administrative unit of the Department of Human Services and its affiliated local departments responsible for determining an applicant's or recipient's eligibility for Public Assistance, Medical Assistance, and Medical Assistance, State-Only. (25) “Incurred medical expenses” means those paid or unpaid bills for medical care which are recognized under State law and are or will be the obligation of the applicant. (26) “Intermediate care facility” means a nursing facility which meets the standards for certification and participation in Title XIX and has entered into a provider agreement with the Department pursuant to COMAR 10.09.11. (27) “Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID)” means a nursing facility for the intellectually disabled which meets the standards for certification and participation in Title XIX and has entered into a provider agreement with the Department pursuant to COMAR 10.09.11. (28) “Living together” means sharing a common household. (29) “Local department of social services (LDSS)” means the Baltimore City or a county social services department under the supervision of the Department of Human Services. (30) “Long-term-care facility” means a skilled nursing facility, intermediate care facility, intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID), chronic hospital, tuberculosis hospital, or mental hospital. (31) “Mandatory State Supplement” means a cash payment a state is required to make under Section 212, P.O. 93-66 to an aged, blind, or disabled person to provide him with the same amount of cash assistance he was receiving under Old Age Assistance, Aid to the Permanently and Totally Disabled, or Public Assistance to the Needy Blind if his SSI payment is less than that amount. (31-1) “Maryland Medicaid Managed Care Program” means the Medicaid reform program established under COMAR 10.67.01—.10, as authorized by Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland. (32) “Medicaid” means Medical Assistance provided under the State Plan approved under Title XIX of the Social Security Act. (33) “Medical Assistance (MA)” means the program administered by the State under Title XIX which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons. (34) “Medical Care Compliance Administration” means the administrative unit of the Department responsible for ensuring that health care services provided to recipients are appropriate and effectively utilized. (35) “Medical Care Operations Administration” means the administrative unit of the Department responsible for maintaining a file of all eligible persons and paying providers of service. (36) “Health Systems Financing Administration” means the administrative unit of the Department responsible for establishing regulations, policies, and procedures for the Medical Assistance program. (37) “Medical institution” means an institution that: (a) Is organized to provide medical care, including nursing and convalescent care; (b) Has the necessary professional personnel, equipment, and facilities to manage the medical, nursing, and other health needs of patients on a continuing basis in accordance with accepted standards; (c) Is authorized under State law to provide medical care; and (d) Is staffed by professional personnel who are responsible to the institution for professional medical and nursing services. (38) “Medically needy” means persons who are otherwise eligible for Medical Assistance, who are not categorically needy, and whose income and resources are within the limits set under the State Plan. (39) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 et seq. (40) “Mental hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.04. (41) “Migrant worker” means a person who moves from place to place to harvest or process seasonal crops. (42) “Old Age Assistance” means a former category of public assistance mandated under Title I of the Social Security Act, and replaced by Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. (43) “One-time-only” means a time-limited certification. (44) “Optional State Supplement” means a cash payment made by a state to an aged, blind, or disabled person, under §1616 of the Social Security Act. (45) “Period under consideration” means the specified months which are assessed for determination of eligibility. (45-1) “Postpartum period” means the period of time beginning on the date a pregnancy ends and ending on the last day of the 12th month following the end of pregnancy. (46) “Public Assistance” means cash assistance payments, including state supplementary payments, made to persons who are eligible for programs administered under Title IV-A or Title XVI of the Social Security Act. (47) “Public Assistance to the Needy Blind” means a former category of public assistance mandated under Title X of the Social Security Act and replaced by Title XVI of the Social Security Act, 42 U.S.C. §§1381 et seq. (48) Public Institution. (a) “Public institution” means an institution that is the responsibility of a governmental unit or over which a governmental unit exercises administrative control. (b) “Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more persons unrelated to the proprietor. (c) “Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves no more than 16 residents. (49) Publicly Operated Community Residence that Serves No More Than 16 Residents. (a) “Publicly operated community residence that serves no more than 16 residents” means a facility that is publicly operated, serves no more than 16 residents, and offers services beyond food and shelter. (b) “Publicly operated community residence that serves no more than 16 residents” does not mean: (i) Residential facilities located on or adjacent to any large institution or multipurpose center; (ii) Educational or vocational institutions that primarily provide an approved or accredited program to some or all of their residents; (iii) Medical treatment facilities which provide medical care or remedial service on an inpatient basis; or (iv) Correctional or holding facilities which provide for persons who are prisoners, have been arrested or detained, or are held under court order as material witnesses or juveniles. (49-1) “Qualified alien” means an alien who: (a) Has been fully admitted for permanent residence under the Immigration and Nationality Act (INA); (b) Has been granted asylum under §208 of the INA; (c) Has been admitted into the United States as a refugee under §207 of the INA; (d) Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year; (e) Has had deportation withheld under §243(h) of the INA; or (f) Has been granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980. (50) “Recipient” means a person who is certified as eligible for Medical Assistance. (51) “Redetermination” means a determination regarding continuing eligibility of a recipient. (52) “Remedial service” means any service, other than a physician's service, provided within the scope of practice as defined by State law by a person licensed as a practitioner under State law. (53) “Resources” means accumulated personal wealth over which a person has the authority or power to liquidate his interest, including cash savings, savings accounts, certificates of deposit, money market certificates, checking accounts, stocks, bonds, cash value of life insurance, burial plots, prepaid burial plans, real property, personal property, mortgages, and mutual funds. (54) “Retroactive coverage” means the availability of coverage for incurred medical expenses covered under the State Plan for a period not to exceed 3 months before the month of application. (55) “Skilled nursing facility” means a nursing facility which: (a) Is licensed as a comprehensive care facility (SNF/CCF), or as an extended care facility (SNF/ECF), or both; (b) Meets the requirements for certification and participation in Title XIX of the Social Security Act as a skilled nursing facility; and (c) Has entered into a provider agreement with the Department pursuant to COMAR 10.09.10. (56) “Social Security Administration” means the administrative unit in the United States Department of Health and Human Services responsible for administering programs under Titles II, IV-A, IV-D, and XVI of the Social Security Act. (57) “Spend-down” means a procedure by which an applicant who is ineligible for Medical Assistance due to excess income becomes eligible by deducting incurred medical expenses from excess income. (58) “Spouse” means a person who has been determined to be the husband or wife of another person under State law or for the purposes of determining eligibility for Social Security benefits. (59) “State Plan” means a comprehensive written commitment by a Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of a medical assistance program in accordance with federal requirements. (60) “Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §§1381 et seq. (61) “Third party” means a person, institution, corporation, public or private agency or organization who is or may be liable to pay all or part of the medical cost of injury, disease, or disability of an applicant or recipient. (62) “Title XIX” means the title of the Social Security Act, 42 U.S.C. §§1396 et seq., which governs establishment of a medical assistance program for low income persons. (63) “Tuberculosis hospital” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. #### Regulation .02-1 MAGI Definitions. *COMAR 10.09.24.02-1* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). (2) Authorized Representative” has the meaning stated in COMAR 10.01.04.12. (3) “Designee” means any entity designated to act on behalf of the Department such as: (a) Baltimore City or a county social services department under the supervision of the Department of Human Services; (b) Baltimore City Health Department and its subgrantees, or a county health department; and (c) The Maryland Health Benefit Exchange. (4) “Insurance Affordability Program” means a program that is one of the following: (i) The Maryland State Medicaid program; (ii) The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; (iii) An optional State basic health program established under §1331 of the Affordable Care Act; (iv) A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; and (v) A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act. (5) “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. (6) “MAGI exempt coverage group” means a coverage group as described under Regulation .03 of this chapter whose eligibility is not determined by MAGI or by the Maryland Health Benefit Exchange. (7) “Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program. #### Regulation .03 Coverage Groups. *COMAR 10.09.24.03* A. The following individuals, including recipients of Temporary Cash Assistance, may be determined eligible for the MAGI coverage groups: (1) Parents and other caretaker relatives whose household income is equal to or less than 123 percent of the federal poverty level; (2) Pregnant and postpartum women of any age whose household income is equal to or less than 250 percent of the federal poverty level; (3) Adults 19 years old or older and younger than 65 years old who are not entitled to or enrolled in Medicare Part A or Part B, whose household income is equal to or less than 133 percent of the federal poverty level, including adults living with dependent children who have provided minimum essential health care coverage for those children; (4) Children younger than 21 years old and whose household income is equal to or less than 133 percent of the federal poverty level; and (5) Former Foster Care individuals who: (a) For individuals who turned 18 years old before January 1, 2023: (i) Are younger than 26 years old; (ii) Are not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and (iii) Were formerly in a Maryland out-of-home placement, including categorical Medical Assistance, during the foster care period in which they either turned 18 years old or attained a higher age during extended out-of-home placement as described under COMAR 07.02.11.04B; and (b) For individuals who turned 18 years old on or after January 1, 2023: (i) Are younger than 26 years old; (ii) Are not enrolled for coverage under an eligibility group described in §1902(a)(10)(A)(i)(I)—(VII) of the Act; and (iii) Were formerly in an out-of-home placement in any state, including categorical Medical Assistance, during the foster care period in which they either turned 18 years old or attained a higher age during extended out-of-home placement as described under COMAR 07.02.11.04B. B. An individual receiving SSI, Mandatory State Supplement, or Optional State Supplement is eligible for the MAGI Exempt coverage groups without having to file a separate application and covered as Categorically Needy. C. Transitional Medical Assistance. (1) If a family loses Medical Assistance solely because of increased income from employment of the caretaker relative as defined under Regulation .02B(10)(a) of this chapter, all members of the family shall be eligible for Medical Assistance during the immediately succeeding 12-month period if the parents or caretaker relatives were eligible for Medical Assistance under §A(5) of this regulation in 3 or more months of the 6-month period immediately preceding the month in which they became ineligible for Medical Assistance. (2) Termination of Transitional Medical Assistance. (a) Transitional Medical Assistance during the 12-month period described under §C(1) of this regulation shall terminate at the close of the first month in which the family ceases to include a child younger than 21 years old. (b) Termination of assistance may not become effective until the Department has provided the family with notice of the grounds for the termination. (3) Continuation in Certain Cases until Redetermination. With respect to a person who would cease to receive Medical Assistance under §C(2) of this regulation but who may be eligible for Medical Assistance under this chapter, the Department may not discontinue Medical Assistance until the Department has determined that the person is not eligible for Medical Assistance under this chapter. D. The following individuals may be determined eligible for a MAGI Exempt coverage group after filing a separate application for Medical Assistance and, if determined eligible, are covered as Categorically Needy: (1) An individual who would be eligible for SSI, or Optional State Supplement benefits except for a requirement of those programs that is specifically prohibited under Title XIX. (2) A person who in December, 1973, was eligible for Medical Assistance as an essential spouse. Medical Assistance will continue if this person: (a) Continues to meet the December, 1973, criteria of the State's approved Old Age Assistance, Aid to the Permanently and Totally Disabled, or Public Assistance to the Needy Blind plans to be considered an essential spouse; and (b) Lives with an aged, blind, or disabled spouse who continues to meet the December, 1973, criteria of the State's approved Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled plans. (3) A person who in the month of December, 1973, was eligible for Medical Assistance and was an inpatient in a long-term care facility qualified to receive Medical Assistance payments, and, if not institutionalized, would have been eligible for Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled. Medical Assistance will continue if this person: (a) Needed and received inpatient care continuously since December, 1973; (b) Continues to need and receive inpatient care; and (c) Continues to meet the eligibility criteria of the Old Age Assistance, Public Assistance to the Needy Blind, or Aid to the Permanently and Totally Disabled plan for December, 1973. (4) A person who: (a) Meets all current requirements for Medical Assistance eligibility except the criteria for blindness or disability; (b) Was eligible for Medical Assistance in December, 1973, as a blind or disabled person, whether or not he was receiving cash assistance in December, 1973; and (c) For each consecutive month after December, 1973, continues to meet the criteria for blindness or disability and the other conditions of eligibility used under the Medical Assistance plan in December, 1973. E. The following individuals may be determined eligible for a MAGI Exempt coverage group after filing a separate application, and if determined eligible, are covered as Medically Needy: (1) A pregnant woman who has been denied AFDC solely because her income or resources exceed the cash assistance level; (2) A person younger than 21 years old; (3) A caretaker relative (and spouse); (4) An aged, blind, or disabled person; and (5) A person who was eligible as Medically Needy in December, 1973, on the basis of the blindness or disability criteria of Aid to the Permanently and Totally Disabled or Public Assistance to the Needy Blind and who continues to meet current requirements except for blindness or disability criteria. F. Continuous Eligibility for Pregnant Women. The Department will provide Medical Assistance through the last day of the month in which the postpartum period ends for a pregnant woman who: (1) Was eligible and enrolled under §A(2) of this regulation; and (2) Because of a change in household income, will not otherwise remain eligible. #### Regulation .03-1 Coverage Group for Women with Breast or Cervical Cancer — Purpose, Definitions, and Eligibility Criteria. *COMAR 10.09.24.03-1* A. Purpose. (1) The purpose of Regulations .03-1 and .03-2 of this chapter is to exercise the State's option under Title XIX of the Social Security Act to create a new Medical Assistance optional categorically needy coverage group for women who need treatment for breast cancer, cervical cancer, or precancerous conditions, in accordance with the Breast and Cervical Cancer Prevention and Treatment Act of 2000 (Public Law 106-354). (2) Applications submitted under Regulations .03-1 and .03-2 of this chapter shall no longer be accepted after December 31, 2013. (3) An individual who has submitted an application in accordance with §A(1) of this regulation and who has been determined eligible will receive benefits under Regulations .03-1 and .03-2 of this chapter after December 31, 2013. (4) Effective July 31, 2024, any individual who was previously covered under §A(3) of this regulation will no longer receive benefits under Regulations .03-1 and .03-2 of this chapter. B. Definitions. In Regulations .03-1 and .03-2 of this chapter, the following terms have the meanings indicated: (1) “Applicant” means an individual whose application for the Medical Assistance eligibility under the women's breast and cervical cancer coverage group has been submitted to the Department or its authorized representative, but has not received final action. (2) “Application date” means the date on which a written, signed application for Medical Assistance eligibility under the women's breast and cervical cancer coverage group is received by the Department or its authorized representative. (3) “Breast and Cervical Cancer Diagnosis and Treatment Program” means the State-funded program of cancer diagnosis and treatment services, which is: (a) Governed by COMAR 10.14.02; and (b) Administered by the Department's Center for Cancer Surveillance and Control. (4) “Cancer treatment services” means active medical treatment for breast cancer, cervical cancer, or a precancerous condition, not including palliative care. (5) “Categorically needy coverage group” means a category of Medical Assistance eligibility defined at Regulation .03A of this chapter. (6) “Creditable health insurance coverage” means having one or more of the following types of coverage: (a) A group health plan; (b) Health insurance coverage with medical care benefits provided directly or through insurance, reimbursement, or otherwise and including items and services paid for as medical care, under any: (i) Hospital or medical service policy or certificate; (ii) Hospital or medical service plan contract; or (iii) Health maintenance organization contract offered by a health insurance issuer; (c) Medicare Part A or Part B; (d) Medical Assistance; (e) Armed forces insurance; or (f) A state health risk pool. (7) “Enrollee” means a woman who is determined eligible and is receiving Medical Assistance benefits under Regulations .03-1 and .03-2 of this chapter. (8) “Health professional” means a licensed physician or certified registered nurse practitioner. (9) “Institutionalized person” has the meaning specified at Regulation .08B of this chapter. (10) “Mandatory Medical Assistance categorically needy coverage group” means a Medical Assistance categorically needy coverage group which the federal government requires a state to cover under the State Plan, in accordance with the Code of Federal Regulations. (11) “Maryland Breast and Cervical Cancer Screening Program” means the National Breast and Cervical Cancer Early Detection Program in Maryland which: (a) Is funded by the State or federal government; (b) Is administered by the Department's Center for Cancer Surveillance and Control through the local jurisdictions; and (c) Has income and other eligibility requirements. (12) “National Breast and Cervical Cancer Early Detection Program (NBCCEDP)” means the program of the Centers for Disease Control (CDC), established under Title XV of the Public Health Service Act. (13) “Needs treatment” means that, according to a written certification by a health professional, the individual needs cancer treatment services, such as chemotherapy, radiation, or surgery. (14) “Precancerous condition” means for: (a) Cervical cancer, a condition diagnosed as cervical intra-epithelial neoplasia I, II, or III; or (b) Breast cancer, a condition diagnosed as atypical ductal hyperplasia or lobular carcinoma in-situ. (15) “Screening services” means services provided by the Maryland Breast and Cervical Cancer Screening Program to screen for breast or cervical cancer, including clinical breast examinations, mammograms, pelvic examinations, Papanicolaou (Pap) tests, and diagnostic services such as breast ultrasound or colposcopically directed biopsy, to ensure that all women with abnormal screening results receive timely and adequate diagnostic and treatment services. (16) “Uninsured” means: (a) Not otherwise having creditable health insurance coverage for cancer treatment services; or (b) Having creditable health insurance coverage, but the cancer treatment services ordered by a health professional are not covered due to one of the following reasons: (i) The services are not included among the benefits covered by the individual's health insurance plan; (ii) A period of exclusion has been applied to the individual's health insurance coverage, such as for a preexisting condition; or (iii) The individual has exhausted the health insurance plan's covered benefits. (17) “Women's breast and cervical cancer coverage group” means the Medical Assistance optional categorically needy coverage group covered under Regulations .03-1 and .03-2 of this chapter. C. Eligibility. (1) The Department shall determine that an applicant or enrollee is eligible for Medical Assistance coverage under Regulations .03-1 and .03-2 of this chapter if the individual: (a) Is a woman; (b) Is 40—64 years old; (c) Is uninsured, with the Department not requiring a waiting period of prior uninsurance; (d) Received screening services, in accordance with Regulation .03-2A of this chapter; (e) Had a biopsy through the: (i) Maryland Breast and Cervical Cancer Screening Program which resulted in a diagnosis of cervical cancer or a precancerous condition; or (ii) Breast and Cervical Cancer Diagnosis and Treatment Program which resulted in a diagnosis of breast cancer or a precancerous condition; (f) Needs treatment; (g) Is not an institutionalized person; (h) Meets the nonfinancial eligibility requirements for Medical Assistance, as specified in Regulation .05 of this chapter; and (i) Is not eligible for a mandatory Medical Assistance categorically needy coverage group. (2) The requirements in this chapter related to financial eligibility, income, and resources: (a) Shall apply for assessing eligibility for a mandatory Medical Assistance categorically needy coverage group; and (b) May not apply for determining eligibility for the WBCCHP under Regulations .03-1 and 03-2 of this chapter. #### Regulation .03-2 Coverage Group for Women with Breast or Cervical Cancer — Eligibility, Determination, and Covered Services Process. *COMAR 10.09.24.03-2* A. Screening. A woman is considered to have received screening services if the: (1) NBCCEDP funded all or part of the woman's screening services; or (2) NBCCEDP did not fund all or part of the woman's screening services, but the screening services were rendered by a provider or entity funded at least in part by the NBCCEDP and the: (a) Screening services were within the scope of a grant, subgrant, or contract under the State's NBCCEDP; or (b) NBCCEDP grantee elected to include such screening services by that provider as screening services pursuant to the NBCCEDP. B. Assistance Unit. An applicant or enrollee shall be considered as an assistance unit of one person, including only the applicant or enrollee. C. Application Process. The requirements of Regulation .04 of this chapter shall apply, except for the following differences for the women's breast and cervical cancer coverage group: (1) For the initial eligibility application, an individual shall apply through the Maryland Breast and Cervical Cancer Screening Program in the local jurisdiction; (2) The applicant's or enrollee's written application for an initial determination or a redetermination shall be on the form designated by the Department for the women's breast and cervical cancer coverage group; (3) The Department shall: (a) Determine initial eligibility, retroactive or current, based on: (i) A signed application received from the applicant; (ii) A form signed by a health professional, certifying that the enrollee needs treatment and, for a redetermination, specifying the anticipated length of treatment; (iii) Confirmation from the Maryland Breast and Cervical Cancer Screening Program that the applicant received screening services in accordance with §A of this regulation; (iv) Confirmation from the Maryland Breast and Cervical Cancer Screening Program or the Breast and Cervical Cancer Diagnosis and Treatment Program that the applicant had a biopsy which resulted in a diagnosis of breast cancer, cervical cancer, or a precancerous condition; and (v) Additional information obtained by the Department to verify the applicant's eligibility in accordance with Regulation .03-1C of this chapter; (b) Redetermine an enrollee's eligibility at least every 12 months, before the end of the certification period, based on the following: (i) An application completed by the enrollee, verifying continuing eligibility under Regulations .03-1 and .03-2 of this chapter; and (ii) A certification form completed by a health professional, verifying that the enrollee needs treatment and specifying the expected length of treatment; (c) Verify, before determining or redetermining eligibility, that the applicant or enrollee is not: (i) Currently covered by Medical Assistance and does not have an application under consideration in a coverage group which covers all State Plan services without requiring spend down or payment of a premium; or (ii) Eligible for a mandatory Medical Assistance categorically needy coverage group; (d) Determine or redetermine eligibility within 45 days after receipt of a signed application; (e) Refer the applicant or recipient to the local department of social services or local health department for an eligibility determination or redetermination if the individual may be eligible for a mandatory Medical Assistance categorically needy coverage group; and (f) Notify the applicant or enrollee of the eligibility decision and the rights for appeal and fair hearing, in accordance with Regulation .13 of this chapter; and (4) Based on the application date, the Department shall establish a period under consideration, which shall be: (a) For retroactive eligibility for an initial application, not more than 3 months immediately preceding the month of application, if as of this earlier date the applicant would have met the requirements at Regulation .03-1C of this chapter; (b) For current eligibility for an initial application, a 12-month period beginning with the month of application; or (c) For current eligibility for a redetermination, the lesser of: (i) A 12-month period; or (ii) The number of months that the individual needs treatment. D. Certification Period. (1) An enrollee's certification period shall begin: (a) For retroactive eligibility with the initial determination, the first day of the month which is up to 3 months preceding the month of the application date if, as of this earlier date, the applicant would have met the requirements of Regulation .03-1C of this chapter, including having been screened for and diagnosed with breast cancer, cervical cancer, or a precancerous condition; (b) For current eligibility with the initial determination, the first day of the month of the application date; or (c) For a redetermination, the first day of the month immediately following the month in which the previous certification period ended. (2) The effective date for retroactive or current coverage under Regulations .03-1 and .03-2 of this chapter shall be April 1, 2002 or later. (3) An enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter shall end as of the: (a) End of a certification period for a: (i) 12-month period; or (ii) A period less than 12 months, based on how long the enrollee needs treatment; or (b) Date when the enrollee is no longer eligible under Regulations .03-1 and .03-2 of this chapter due to: (i) Death; (ii) Establishment of residency in another state; (iii) Becoming 65 years old; (iv) Becoming an institutionalized person; or (v) No longer being uninsured, such as becoming eligible for another Medical Assistance coverage group which covers all State Plan services without requiring spend down or payment of a premium. E. Redetermination. (1) Scheduled Redeterminations. (a) The Department shall issue a redetermination package to an enrollee at least 60 days before the end of the certification period. (b) Based on the information presented, the Department shall determine whether the enrollee: (i) Qualifies for continuing eligibility under the women's breast and cervical cancer coverage group with a new 12-month certification period, because the enrollee needs treatment for at least 12 more months; (ii) Qualifies for continuing eligibility under the women's breast and cervical cancer coverage group with a new certification period of less than 12 months, based on the length of time that the enrollee needs treatment; (iii) Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group because the required information was not received by the Department by the specified deadline, but shall be considered for continuing eligibility under the women's breast and cervical cancer coverage group if the necessary information is received by the Department within 6 months of the date of termination; (iv) Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group and does not appear to qualify for a mandatory Medical Assistance categorically needy coverage group; or (v) Does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group because the enrollee may qualify for a mandatory Medical Assistance categorically needy coverage group, and shall be referred for an eligibility determination at the local department of social services. (2) Unscheduled Redeterminations. (a) An enrollee shall inform the Department within 10 days of a change in circumstances, which may impact the enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter. (b) If the Department receives notice of a change in circumstances which may impact the enrollee's eligibility under Regulations .03-1 and .03-2 of this chapter, the Department shall follow the procedures in §E(1)(b) of this regulation for redeterminations. (3) If the Department determines as part of a scheduled or unscheduled redetermination that an enrollee does not qualify for continuing eligibility under the women's breast and cervical cancer coverage group, the Department shall determine whether the individual qualifies for any other coverage groups under this chapter or COMAR 10.09.11. F. Covered Services. Enrollees shall be entitled to full coverage for all services covered under the State Plan, not limited to cancer treatment services, except for enrollment in: (1) The HealthChoice Maryland Medicaid Managed Care Program, in accordance with COMAR 10.09.62 — 10.09.67; (2) Rare and Expensive Case Management (REM), in accordance with COMAR 10.09.69; (3) A home and community-based services waiver under §1915(c) of Title XIX of the Social Security Act; (4) Medicare buy-in for Medical Assistance payment of Medicare premiums, copayments, and deductibles for Medicare eligible persons; (5) Program of All-Inclusive Care for the Elderly; or (6) Coverage for services in a long-term care facility exceeding 30 consecutive days. #### Regulation .03-3 Medicare Savings Program Coverage. *COMAR 10.09.24.03-3* A. Non-Financial and Resource Eligibility for the Medicare Savings Programs. In order to be eligible for the Medicare savings program under §§E—H of this regulation, an individual: (1) May not be enrolled in Medical Assistance or the Maryland Children's Health Program under this chapter or under COMAR 10.09.11; (2) Shall be entitled to hospital insurance benefits under Medicare Part A, or medical insurance benefits under Medicare Part B, or both, with or without payment of premiums; (3) Shall meet the non-financial eligibility requirements for Medical Assistance under this chapter; and (4) Shall be part of an assistance unit whose countable resources do not exceed: (a) For individuals eligible under §§E—G of this regulation, 3 times the maximum amount allowed by the Supplemental Security Income program, as adjusted from time to time by the Social Security Administration, for the number of persons in the assistance unit; or (b) For individuals eligible under §H of this regulation, 2 times the maximum amount allowed by the Supplemental Security Income program for the number of persons in the assistance unit. B. Medicare Savings Program. (1) The Medical Assistance benefits for individuals eligible under §§E—H of this regulation are limited to the Medicare savings program benefits described under those sections of this regulation. (2) Current eligibility for Medicare savings program benefits shall continue until the recipient is determined ineligible. C. Application and Redetermination Procedures. (1) The requirements under this chapter for applications and redeterminations shall apply for §§E—H of this regulation except as described in §C(2)—(5) of this regulation. (2) Applications and re-applications for eligibility under this regulation shall be filed at: (a) The Department or its designee; (b) The Maryland Department of Aging; (c) An area agency on aging; or (d) A surrogate organization approved by the Department. (3) The initial application may be made at a face-to-face interview or by mail with an agency defined under §C(2) of this regulation, as authorized by the Department. (4) Redeterminations. (a) Applications for redetermination of eligibility shall be mailed by the Department or its designee to the recipient or representative for completion at least once every 12 months. (b) The recipient or representative shall return the application to the Department or its designee and indicate: (i) Any changes that have occurred since the prior redetermination of eligibility, such as a new address; or (ii) That there is no new information to report, by marking “NO CHANGE” on the front of the application. (c) Upon notice of a change in circumstances, a redetermination of eligibility under §§E—H of this regulation shall be completed by the Department or its designee. (5) Eligibility under §§E—H of this regulation shall be initially determined and redetermined by the Department or its designee. D. Income and Resource Consideration. (1) Assistance Unit. When financial eligibility is determined for an applicant or recipient under §§E—H of this regulation, the countable income and resources of the following individuals shall be considered and measured against the income and resource standards specified in this regulation for the number of persons in the assistance unit: (a) The applicant or recipient; and (b) The applicant's or recipient's spouse when living in the same household, whether or not the spouse is eligible for the same benefits under this regulation. (2) Determining Countable Income and Resources. (a) Income and resources shall be evaluated for §§E—H of this regulation in accordance with the provisions for aged, blind, or disabled adults residing in the community, as described under this chapter, in addition to the following resource exclusions: (i) The cash value of life insurance; and (ii) An amount up to $1,500 for burial or funeral funds, unless included in the annual resource limit for the full Medicare Part D Low-Income Subsidy (LIS) program. (b) Cost of Living Disregard. The annual cost of living increase in Social Security income under Title II of the Social Security Act shall be disregarded through the month following the month in which the annual federal poverty level update is published in the Federal Register. E. Qualified Medicare Beneficiary (QMB). (1) An individual is eligible for QMB benefits if: (a) All of the requirements of §A of this regulation are satisfied; and (b) The assistance unit's net countable income does not exceed 100 percent of the federal poverty level for the number of persons in the assistance unit. (2) Current eligibility for QMB benefits shall be effective the first day of the month after the month in which QMB eligibility is determined. (3) Retroactive coverage before the month of application is not available for QMB benefits. (4) Medicare savings program benefits for a QMB-eligible person shall include coverage of the following expenses by the Medical Assistance program: (a) Monthly premium for Medicare Part B; (b) Monthly premium for Medicare Part A, if the individual, due to insufficient working quarters, is not entitled to free coverage by the Social Security Administration; and (c) Medicare Part A and Part B deductibles and co-insurance for services covered by Medicare, regardless of whether the services are covered under the Medical Assistance State Plan. F. Specified Low-Income Medicare Beneficiary (SLMB). (1) An individual is eligible for SLMB benefits if: (a) All of the requirements of §A of this regulation are satisfied; and (b) The assistance unit's net countable income is greater than 100 percent but less than 120 percent of the federal poverty level for the number of persons in the assistance unit. (2) Current eligibility for SLMB benefits shall be effective the first day of the month of application. (3) An individual may qualify for retroactive SLMB benefits for up to 3 calendar months before the month of application, if the person meets the SLMB eligibility criteria for each of those prior months. (4) Medicare savings program benefits for a SLMB-eligible person shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part B. G. Qualifying Individual QI. (1) An individual is eligible for QI benefits if: (a) All of the requirements of §A of this regulation are satisfied; (b) The assistance unit's net countable income is at least 120 percent but less than 135 percent of the federal poverty level for the number of persons in the assistance unit; and (c) The individual is not otherwise eligible for Medical Assistance under this chapter. (2) Current eligibility for QI benefits shall be effective the first day of the month of application. (3) An applicant may qualify for up to 3 calendar months before the month of application for retroactive QI benefits if: (a) The individual meets the QI eligibility criteria for each of those prior months under consideration; and (b) Each retroactive month is no earlier than January 1 of the calendar year in which the individual applied for QI benefits. (4) Medicare savings program benefits for a QI eligible individual shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part B. H. Qualified Disabled and Working Individual (QDWI). (1) An individual is eligible for QDWI benefits if: (a) The individual: (i) Meets all of the requirements under §A of this regulation; (ii) Is younger than 65 years old; (iii) Was determined disabled by the Social Security Administration (SSA) but lost Social Security benefits solely due to employment; (iv) Is entitled to enroll in Medicare Part A under §1818A of the Social Security Act; and (v) Is not otherwise eligible for Medical Assistance under this chapter; and (b) The assistance unit's net countable income does not exceed 200 percent of the federal poverty level for the number of persons in the assistance unit. (2) SSA shall establish the effective date of QDWI coverage based on the: (a) Individual's date of application for QDWI benefits; (b) Date of potential QDWI eligibility, as specified in a letter from SSA to the individual; and (c) Dates of the next Medicare open enrollment period. (3) Medicare savings program benefits for a QDWI-eligible person shall consist of coverage by the Medical Assistance program of the monthly premium for Medicare Part A. (4) Only the individual who is identified by SSA as potentially eligible may be eligible for QDWI benefits in a QDWI assistance unit. (5) Retroactive coverage before the month of application is not available for QDWI benefits. (6) If an individual delays in applying for QDWI benefits after notification of potential QDWI eligibility by SSA, the individual may be required by SSA to pay a premium surcharge for Medicare Part A, unless the individual is covered by an employer-based group health plan. (7) Eligibility for QDWI benefits shall continue until the earliest of the following dates: (a) The end of the month after the Department: (i) Determines that the individual is no longer eligible for QDWI benefits in accordance with this regulation; and (ii) Sends the recipient a notice of termination at least 10 days before the effective date; (b) The end of the month before the month that the individual becomes: (i) Re-entitled to premium-free Medicare Part A; or (ii) 65 years old; (c) The date of death; or (d) The end of the month following the month that the individual: (i) Is notified by SSA that the individual no longer has a disabling impairment; or (ii) Files a request for termination of QDWI enrollment. #### Regulation .03-4 Medicare Buy-In Coverage for Medical Assistance Recipients. *COMAR 10.09.24.03-4* A. If a recipient, who is determined federally eligible and enrolled in Medical Assistance or the Maryland Children’s Health Program according to the requirements of this chapter or COMAR 10.09.11, is entitled to hospital insurance benefits under Medicare Part A, or medical insurance benefits under Medicare Part B, or both, with or without payment of premiums, the Medical Assistance program shall provide the same coverage of Medicare savings program expenses as specified for a Qualified Medicare Beneficiary under Regulation .03-3E of this chapter. B. A qualified recipient is automatically made eligible by the Department or its designee for the Medicare buy-in benefits effective the first day of the: (1) Second month after the month in which the individual is determined eligible for Medical Assistance or the first day of the third month of Medicare entitlement, whichever date is later, if the individual is eligible in a long-term care or spend down coverage group; or (2) Month that the individual is eligible for both Medical Assistance and Medicare, if the individual is eligible under COMAR 10.09.24 or COMAR 10.09.11 for Medical Assistance in any coverage groups other than long-term care or spend down. C. A recipient's eligibility for Medicare buy-in benefits shall continue until the recipient is determined ineligible. #### Regulation .04 Application — General Requirements. *COMAR 10.09.24.04* A. The Department or its designee shall determine initial (retroactive and current) and continuing eligibility. B. The Department or its designee shall give oral, written, or electronic information about the Medical Assistance Program such as: (1) Requirements for eligibility; (2) Available services; (3) An individual's rights and responsibilities; (4) Information in plain English, supported by translation services; and (5) Information accessible to disabled individuals requesting an application. C. An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply. D. The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means and in a manner accessible to disabled individuals requesting an application. E. A resident temporarily absent from the State but intending to return may apply for health coverage from an Insurance Affordability Program by telephone, mail, in-person, internet, and other available electronic means to the Department or its designee in any jurisdiction. The individual shall: (1) Demonstrate continued residency in the State; and (2) Meet all nonfinancial and financial requirements in order to be determined eligible. F. Application Filing and Signature Requirements. (1) An individual who wishes to apply for health coverage under an Insurance Affordability Program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant shall be responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice. (2) A signed application is required for all individuals for whom assistance is requested. If, after the completion of an eligibility determination, assistance is requested for additional family members, a signed application is required for those individuals. (3) An exception to §F(2) of this regulation is that a child born to a mother eligible for and receiving Medical Assistance on the date of the child's birth shall be considered to have applied for Medical Assistance and to have been found eligible for Medical Assistance on the date of his birth, and to remain eligible for Medical Assistance for a period of 1 year. (4) A deemed newborn is eligible for receiving Medical Assistance if, at the time of birth, the child’s mother was covered by Medicaid in another state, as a child under CHIP, or under an 1115 waiver. (5) For the purpose of establishing eligibility, the applicant or an authorized representative shall complete and sign the application. (6) In the case of a child applicant younger than 18 years old, a parent of the child shall sign the application, except in the following situations: (a) When the child does not live with a parent, or the parent with whom the child lives is an unmarried minor younger than 18 years old, the caretaker relative other than parent shall sign the application form; (b) An authorized representative who is 18 years old or older shall complete and sign the application form for an unmarried child younger than 18 years old who is not living with a parent or caretaker relative other than the parent. (7) The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. G. An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application; however, the application shall remain the property of the Department or its designee, and the withdrawal may not affect the requirements for establishing periods under consideration specified in §H of this regulation. H. Period under Consideration. (1) The Department or its designee shall establish a current period under consideration based on the date of application established pursuant to §F(6) of this regulation. (2) The period under consideration shall be for retroactive eligibility, the 1, 2, or 3 months immediately preceding the month of application for Medical Assistance, except as specified in §H(3) and §N of this regulation. (3) For a deceased individual, the retroactive and current periods under consideration shall begin as stated in §H(1) and (2) of this regulation and may not extend beyond the month of death. I. Processing Applications — Time Limitations. (1) When a written, telephonic, or electronic application is filed, a decision shall be made promptly but not later than: (a) 10 days from the date of application when filed with the local health department; or (b) 30 days from the date of application when filed with the Department or its designee, with the exception of the local health department. (2) The time standards specified in §I(1) of this regulation cover the period from the date of application to the date the Department or its designee sends a written or electronic notice of its decision to the applicant. (3) Information Required. (a) The applicant shall report all required information. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. (b) The Department or its designee shall inform the applicant or authorized representative in a written or electronic notice of the required information and verifications needed to determine eligibility, and the applicable pending time limit. (c) The applicant or authorized representative shall provide all information and requested verification for the determination of nonfinancial and financial eligibility, including information relating to health insurance coverage or potential third-party payments, early enough for the Department or its designee to meet time limitations. (d) When an applicant completes the application form and requests coverage for: (i) The current period, verification of all elements of eligibility may be required for the current period; (ii) The retroactive period, verification of all elements of eligibility may be required for the retroactive period; or (iii) Both the retroactive and current periods, verification of all elements of eligibility may be required for both the retroactive and current periods. (e) When an applicant fails to complete the application form, or fails to provide the required information and verification to determine eligibility within the applicable time frame, the applicant shall be determined ineligible. (4) Extension of Time Standards. (a) The time standards specified in §I(1) of this regulation shall be extended to allow the applicant sufficient time to complete provision of information when: (i) The applicant is actively attempting to establish his eligibility but has been unable to provide the required information through no fault of his own; or (ii) There is an administrative or other emergency beyond the control of the Department or its designee. (b) The Department or its designee shall document the reason for the delay in the applicant's written or electronic record. The extension of time will continue as long as the requirements of §I(4)(a) of this regulation are met. The Department or its designee shall deny Medical Assistance when these requirements cease to be met. When a subsequent application is made, eligibility and period under consideration shall be determined under §I(7), (8), (9), or (10) of this regulation. (5) The standards of promptness for acting on applications may not be used to deny assistance except as provided in §I(4)(b) of this regulation. (6) The standards of promptness for acting on applications may not be used as a waiting period for granting assistance to eligible persons. (7) Disposition of Application Following a Decision of Ineligibility. If an applicant is determined ineligible for the current period under consideration: (a) Due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, the process and the period under consideration shall be established under §I(9) of this regulation. (b) Solely because of excess income, the application shall be preserved for the period under consideration. The applicant may subsequently establish eligibility for the period under consideration under the “spend-down” process described under Regulations .09C(4) and .10D(5) of this chapter. (c) Solely because of failure to complete the application requirements, including voluntary withdrawal of the application, the application shall be disposed of. If the applicant reapplies, the process and period under consideration shall be established under §I (8), (9), or (10) of this regulation. (8) Reactivation of an Application Following a Decision of Ineligibility for Reasons Other than Nonfinancial Factors or Excess Income. (a) A request for current eligibility following the rejection of an application for reasons other than nonfinancial factors or excess income shall be considered a reactivation of the appropriate earlier application. (b) The reactivation period shall: (i) Apply to the earliest rejected application for which the period under consideration has not expired; (ii) Include the retroactive period associated with the current period. (c) The applicant may establish eligibility for the current period, the retroactive period, or both, at any time during the reactivation period. (9) Reapplication Following a Decision of Ineligibility Due to a Nonfinancial Factor. (a) When an applicant reapplies following a decision of ineligibility due to a nonfinancial factor, a new period under consideration shall be established based on the date a new application is submitted. Coverage may not be provided for any month in which the applicant has not overcome the prior factor of ineligibility. (b) The incurred medical expenses from a past period during which nonfinancial ineligibility or excess resources existed may be applied to excess income, if any, for the current period. (10) Reapplication After the Period Under Consideration Has Expired. (a) A request for eligibility and application filed after the expiration of the period under consideration shall be considered a new application, and a new period under consideration shall be established. (b) A part of the expired current period under consideration may not be converted to a retroactive period for purposes of determining eligibility. A part of the expired current period under consideration may constitute part or all of the 3 months before the month of application for purposes of post-eligibility deductions. (c) The incurred unpaid expenses from the expired period may, with the written consent of the applicant, be applied to excess income, if any, for the current period. (d) The written consent shall be obtained on a form designated by the Department. J. An applicant or recipient may be assisted by an individual or individuals of the applicant's or recipient's choice in the application process and may be accompanied by this individual or individuals when in contact with the Department or its designee. K. Required Application for Income Benefits. (1) Applicants and recipients shall apply for all income benefits to which there may be entitlement, except as specified in §K(3) of this regulation. (2) Income benefits include, but are not limited to, Social Security, Unemployment Compensation, Railroad Retirement, Veterans' Administration, Civil Service annuities, federal, state, or local government and private pensions, and Workers' Compensation. (3) Applicants and recipients determined by the Department or its designee to be unable to perform the required activity because of the applicant's or recipient's physical or mental condition and for whom there is no other individual to perform the activity are not required to apply for income benefits. (4) Determination of initial eligibility may not be delayed pending the results of the application filed for income benefits. (5) At the time of redetermination or reapplication, eligibility will be determined on the basis of the applicant's or recipient's documented reasonable and continuous efforts to establish entitlement to income benefits. L. Social Security Number. (1) Eligibility may not be established until the applicant or recipient furnishes or applies for a Social Security number for any individual whose income is considered in determining financial eligibility. (2) Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant or recipient complies with §L(1) of this regulation. (3) If an applicant or recipient is physically or mentally incapable of acting for himself or herself or lacks the resources to meet the requirements, the Department or its designee shall assist the applicant or recipient in obtaining the necessary evidentiary documents required for application for a Social Security number, and any costs incurred by the Department or its designee shall be paid out of administrative funds. M. Third-Party Liability. (1) Applicants and recipients shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for their medical expenses. (2) Applicants and recipients shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. (3) In accident situations, applicants and recipients shall notify the Department or its designee of the time, date, and location of the accident, the name and address of the attorney, the names and addresses of all parties and witnesses to the accident, and the police report number if an investigation is made. N. Retroactive Eligibility for Applicants or Recipients. An applicant or recipient who desires Medical Assistance coverage for a past period shall apply for retroactive coverage. The date of application for retroactive coverage shall be established in accordance with the requirements of Regulation .09B of this chapter. O. The Department or its designee shall explain the spend-down provision to an applicant determined ineligible because of excess income. P. The Department or its designee shall maintain a written or electronic record including documentation of all required elements of eligibility. Q. The Department or its designee shall restrict disclosures of information concerning applicants and recipients to purposes directly connected with the administration of the Program, including: (1) Establishing eligibility; (2) Determining the extent of coverage under the Program; (3) Providing services for recipients; and (4) Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Program. R. The Department or its designee shall conduct a wage-screening inquiry to determine wages, benefits, and claimant history for each of the following applicants or recipients of Medical Assistance: (1) Childless, adults older than 19 years old and younger than 65 years old; (2) Parents and other Caretaker Relatives; (3) Pregnant and postpartum women; (4) Children younger than 21 years old; and (5) Former Foster Care Children younger than 26 years old. S. An applicant or recipient shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic or electronic application. #### Regulation .04-1 Specific Application Requirements for MAGI Exempt Coverage Groups. *COMAR 10.09.24.04-1* A. All of the requirements of Regulation .04 of this chapter shall apply with the exceptions stated in this chapter. B. Application Filing and Signature Requirements. (1) An individual who wishes to apply for Medical Assistance shall submit a signed application to the Department or its designee in the jurisdiction where his residence is located. (2) A deemed newborn is eligible for receiving Medical Assistance if at the time of birth the child’s mother was covered in another state as a child under CHIP or under a 1115 waiver. (3) An individual who has filed an application may voluntarily withdraw that application; but the withdrawal may not affect the requirements for the penalty period associated with the transfer of a resource specified under Regulation .08I of this chapter. C. Period Under Consideration. Current eligibility shall have a period of consideration of a 6-month period beginning with the month of application for Medical Assistance, except as specified in Regulation .04H(3) of this chapter. D. Processing Applications. When a written or electronic application is filed, a decision shall be made promptly but not later than: (1) 45 days from the date of application in the case of determination of aged and blind individuals; or (2) 60 days from the date of application in the case of determination of disability. E. Extension of Time Standards. (1) The time standards specified in Regulation .04I(1) of this chapter shall be extended to allow the applicant sufficient time to complete provision of information when the examining physician delays or fails to take a required action. (2) Reactivation of an Application Following a Decision of Ineligibility for Reasons Other than Nonfinancial Factors, Excess Resources, or Excess Income. (a) A request for current eligibility following the rejection of an application for reasons other than nonfinancial factors, excess resources, or excess income shall be considered a reactivation of the appropriate earlier application. (b) The reactivation period shall: (i) Apply to the earliest rejected application for which the period under consideration has not expired; and (ii) Include the retroactive period associated with the current period. (c) The applicant may establish eligibility for the current period, the retroactive period, or both, at any time during the reactivation period. (3) Disposition of Application Following a Decision of Ineligibility. If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor or excess resources, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, the process and the period under consideration shall be established under Regulation .04I(9) of this chapter. F. Interview. (1) A face-to-face interview may be conducted at the request of the applicant or the Department or its designee. (2) If it is determined that a face-to-face interview is necessary, the interview may be conducted with an individual other than the applicant in the following situations: (a) When the Department or its designee determines that the applicant cannot participate in the interview because of unusual circumstances such as severely incapacitating disabilities, the interview shall be conducted with an authorized representative or individual acting responsibly on behalf of the applicant; or (b) When the applicant is an unmarried child younger than 18 years old and is not living with a parent or other caretaker relative, the interview shall be conducted with one or more of the following individuals who is 18 years old or older: (i) The parent or other knowledgeable relative of the child; (ii) The nonrelated individual with whom the child is living; or (iii) Another designated responsible individual who is knowledgeable about the child's circumstances. G. Required Application for Income Benefits. (1) Eligibility may not be established until applicants, and recipients furnish proof that they have applied for and taken all other necessary steps to obtain and accept all income benefits to which there may be entitlement, except as specified in §N(3) of this regulation. (2) Income benefits include, but are not limited to: (a) Social Security; (b) Unemployment Compensation; (c) Railroad Retirement; (d) Veterans’ Administration; (e) Civil Service annuities; (f) Federal, state, or local government and private pensions; and (g) Workers’ Compensation. (3) Applicants and recipients determined by the Department or its designee to be unable to perform the required activity because of the applicant’s or recipient’s physical or mental condition and for whom there is no other individuals to perform the activity are not required to apply for income benefits. (4) Determination of initial eligibility may not be delayed pending the results of the application filed for income benefits. (5) At the time of redetermination or reapplication, eligibility will be determined on the basis of the applicant’s or recipient’s documented reasonable and continuous efforts to establish entitlement to income benefits. H. An applicant who is 65 years old or older, or blind or disabled, is not eligible until the applicant furnishes proof that the applicant has applied for or is receiving Part A Medicare. Eligibility determination may not be delayed pending the results of the application filed for Part A Medicare. Periodic reviews of eligibility are necessary for those blind or disabled individuals initially determined ineligible for Medicare because of the required waiting period. I. Social Security Number. (1) Eligibility may not be established until the applicant or recipient furnishes or applies for a Social Security number for each member of an assistance unit and any individual whose income and resources are considered in determining the financial eligibility of an assistance unit. (2) An individual may not be added to an assistance unit until an application is completed for a Social Security number. J. Retroactive Eligibility for Cash Assistance Applicants or Recipients. A Public Assistance applicant or recipient who desires Medical Assistance coverage for a past period shall apply for retroactive coverage. The date of application for retroactive coverage shall be established as follows: (1) The Medical Assistance application date shall be the: (a) Same as that of the Public Assistance application date if the Medical Assistance application is filed within 3 months of the date of the Public Assistance application; or (b) Date the Medical Assistance application is filed if the filing date is more than 3 months after the date of the Public Assistance application. (2) Retroactive eligibility shall be determined in accordance with the requirements of Regulation .10C of this chapter. K. The Department or its designee shall conduct a wage-screening inquiry to determine wages, benefits, and claimant history for an Aged Blind Disabled applicants or recipients that: (1) Resides in a long term care facility; or (2) Is chronically ill and non-ambulatory. L. An applicant shall sign consent forms as needed authorizing the Department or its designee to verify from sources such as an employer, banks, and public or private agencies, information needed to establish eligibility. M. Obtaining Financial Records from Fiduciary Institutions Doing Business in the State as of October 1, 2017. (1) The Department or its designee shall inform the applicant or authorized representative in a written or electronic document of the required information and verifications needed to determine financial eligibility for Medical Assistance and the time limit for submitting the required records. (2) The applicant or authorized representative shall provide all of the required information and verifications needed to determine financial eligibility for Medical Assistance within the time period specified in the notice from the Department or its designee. (3) The Department or its designee shall request financial records necessary to determine the applicant’s eligibility for Medical Assistance on behalf of the applicant when: (a) The applicant or authorized representative is actively attempting to obtain financial documentation to establish eligibility but has been unable to provide the required financial information through no fault of his own from a certain fiduciary institution conducting business in the State; (b) The applicant or authorized representative provides documentation to show their efforts to obtain the information; and (c) The applicant or authorized representative provides a signed consent form designated by the Department or its designee to obtain the records. (4) If the conditions set forth in §M(3) of this regulation are not met, the applicant or authorized representative remains responsible to provide the information. (5) Reimbursement Schedule. The Department or its designee shall reimburse a fiduciary institution for providing copies of financial records in accordance with the Banks and Banking regulations found in 12 CFR §219.3, including the Reimbursement Schedule at Appendix A. #### Regulation .05 Nonfinancial Eligibility Requirements — Citizenship. *COMAR 10.09.24.05* A. Eligibility. To be eligible for federal coverage of full Medical Assistance benefits, an individual shall be: (1) A citizen of the United States, including: (a) An individual who was born in: (i) One of the 50 states; (ii) The District of Columbia; (iii) Puerto Rico; (iv) Guam; (v) The Northern Mariana Islands; or (vi) The Virgin Islands; (b) A child born outside of the United States if: (i) The federal requirements, including the requirements in the Child Citizenship Act of 2000 (Public Law 106-395), are met for the child to automatically acquire United States citizenship upon the child's lawful admission to the United States for permanent residence; (ii) At least one of the child's natural, adoptive, or stepparents is a United States citizen by birth or naturalization; (iii) The child is younger than 18 years old; (iv) The child is residing in the United States in the legal and physical custody of the citizen or naturalized parent; and (v) The child is a lawful permanent resident of the United States; (c) An individual who has been naturalized as a United States citizen; or (d) A national from American Samoa or Swain's Island; (2) A qualified alien, as specified in §C of this regulation, who is eligible in accordance with the requirements related to the 5-year bar specified at §D of this regulation; (3) An honorably discharged veteran of the armed forces of the United States; (4) An alien on active duty in the armed forces of the United States; (5) The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an: (a) Honorably discharged veteran of the armed forces of the United States; or (b) Alien on active duty in the armed forces of the United States; or (6) An alien who is: (a) Eligible for and receiving Supplemental Security Income (SSI); (b) A member of a state or federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or (c) An American Indian born in Canada to whom §289 of the Immigration and Nationality Act (INA) applies. B. Veterans. Veterans of the following foreign armed forces are considered under this regulation to be veterans of the armed forces of the United States: (1) Individuals who served in the Philippine Commonwealth Army during World War II or as Philippine scouts following World War II; and (2) Hmong and other Highland Lao veterans who fought under United States' command during the Vietnam War and who were lawfully admitted to the United States for permanent residence. C. Qualified Aliens. According to §431 of the Personal Responsibility and Work Opportunity and Reconciliation Act of 1996 (PRWORA), qualified aliens admitted to the United States shall include: (1) The following types of aliens, who may be subject to the 5-year bar specified at §D of this regulation, depending on their most recent date of entry and their date of qualified alien status: (a) Aliens who were lawfully admitted to the United States for permanent residence or who since admission were granted lawful permanent resident status in accordance with the INA; (b) Aliens granted parole for at least 1 year under §212(d)(5) of the INA; and (c) A documented or undocumented immigrant who was battered or subjected to extreme cruelty by the individual's United States citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the immigrant, if: (i) The spouse or parent consented to, or acquiesced in, the battery or cruelty; (ii) The abusive act or acts occurred in the United States; (iii) The individual responsible for the battery or cruelty no longer lives in the same household as the victim; (iv) A Violence Against Women Act immigration case or a family-based visa petition has been filed; and (v) There is a substantial connection between the battery or cruelty and the need for Medical Assistance benefits; and (2) The following types of aliens, who are not subject to the 5-year bar specified in §D of this regulation: (a) Alien children and pregnant women who are lawfully residing in the United States, including legal permanent residents who have resided in the United States for less than 5 years as described under §214 of the Children's Health Insurance Program Authorization Act of 2009 (CHIPRA); (b) Aliens who were lawfully admitted to the United States for permanent residence as Amerasian immigrants under §584 of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1988; (c) Refugees admitted under §207 of the INA; (d) Aliens granted asylum under §208 of the INA; (e) Aliens whose deportation is being withheld under: (i) §243(h) of the INA as in effect prior to April 1, 1997; or (ii) §241(b)(3) of the INA, as amended; (f) Cuban or Haitian entrants, as defined at §501(e) of the Refugee Education Assistance Act of 1980; (g) Aliens granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980; (h) Children receiving federal payments for foster care or adoption assistance under Part B or E of Title IV of the Social Security Act, if the child's foster or adoptive parent is considered a citizen or qualified alien; and (i) Victims of a severe form of trafficking, in accordance with §107(b)(1) of the Trafficking Victims Protection Act of 2000, who have been subjected to: (i) Sex trafficking if the act is induced by force, fraud, or coercion, or the individual who was induced to perform the act was younger than 18 years old on the date that the visa application was filed; or (ii) Involuntary servitude. D. Five-Year Bar to Federal Medical Assistance for Qualified Aliens. (1) Except for coverage of emergency medical services specified at Regulation .05-2 of this chapter, qualified aliens in the categories specified in §C(1) of this regulation who entered the United States on or after August 22, 1996, were not eligible for federally-funded Medical Assistance for 5 years from the date that the qualified alien: (a) Entered the United States with the status of a qualified alien; or (b) Obtained the status of a qualified alien, if the individual did not enter the United States as a qualified alien. (2) The 5-year bar specified in §D(1) of this regulation shall also be applied to qualified aliens who entered the United States before August 22, 1996, but did not remain continuously present in the United States from the last date of entry before August 22, 1996 until the date of qualified alien status. (3) An alien is not considered to be continuously present in the United States as specified in §D(2) of this regulation if, before the date of qualified alien status, the alien had: (a) A single absence from the United States of more than 30 days; or (b) Absences from the United States totaling more than 90 days. (4) The 5-year bar to eligibility for federal Medical Assistance benefits, specified in §D(1) of this regulation, does not apply to: (a) Qualified aliens in the categories specified at: (i) §C(1) of this regulation, who are not subject to the 5-year bar in accordance with §D(1) or (2) of this regulation; or (ii) §C(2) of this regulation; (b) A qualified alien who is: (i) An honorably discharged veteran of the armed forces of the United States; (ii) On active duty in the armed forces of the United States; or (iii) The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an honorably discharged veteran or individual on active duty in the armed forces of the United States; and (c) Lawful permanent residents who: (i) Entered the United States under another exempt category specified at §D(4)(a)—(b) of this regulation; and (ii) Converted to lawful permanent resident status. (5) Effective December 1, 2009, as authorized by the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA), the 5-year bar will no longer apply to Medical Assistance or Children's Health Insurance Program eligibility for pregnant women and children who are qualified aliens. #### Regulation .05-1 Documentation of Citizenship and Identity. *COMAR 10.09.24.05-1* A. An applicant or recipient shall be required as a condition of eligibility to provide documentary evidence of identity as well as citizenship or nationality, to the Department's satisfaction, based on federal requirements, if the individual is: (1) Declared to be a citizen or national of the United States; and (2) Being determined for: (a) Initial eligibility based on an application filed on or after September 1, 2006; or (b) Continuing eligibility based on a redetermination with an end date on or after September 30, 2006. B. The requirements of this regulation shall be met for all Medical Assistance coverage groups except for: (1) Supplemental Security Income beneficiaries; (2) Newborns who are deemed eligible, for a period of 1 year, for Medical Assistance based on the mother's Medical Assistance eligibility for the newborn's date of birth; (3) Newborns deemed eligible who are born to an otherwise eligible non-qualified alien woman meeting the requirements of Regulation .05-2 of this chapter who has filed an application and has been determined eligible for Medical Assistance for the newborn's date of birth; (4) Individuals who are entitled to Medicare benefits or enrolled in any part of Medicare; (5) Individuals receiving SSDI disability insurance benefits under §223 of the Social Security Act, or monthly benefits under §202 of the Act, based on the individual's disability; (6) Children who are receiving foster care or adoption assistance under Title IV-B or Title IV-E of the Social Security Act; and (7) Other categories of individuals who are considered by the federal government to have previously presented satisfactory documentary evidence of identity as well as citizenship or nationality. C. An applicant may not be determined eligible for Medical Assistance until the requirements of this regulation are met. D. An applicant may be determined eligible for Medical Assistance for a period of 90 days to provide requested documents. When an applicant fails to provide documentation of citizenship within the 90 day period, the applicant shall be determined ineligible. E. Continuing eligibility for a recipient may not be approved at redetermination until the requirements of this regulation are met. F. If an applicant or recipient fails to meet the requirements of this regulation within the time standards specified at Regulation .04I(1) of this chapter, and the time standards are not extended in accordance with Regulation .04I(4) of this chapter, the Department shall: (1) Deny eligibility for an applicant; or (2) Terminate eligibility for a recipient, in accordance with the requirements for timely notice in COMAR 10.01.04. G. The reactivation requirements in Regulation .04I(8) of this chapter shall apply to applicants and recipients deemed MAGI exempt. The documentation requirements of this regulation are subsequently met within the current period under consideration for the: (1) Applicant's denied application; or (2) Recipient's terminated period of continuing eligibility. H. If there is documentation in an applicant's or recipient's written or electronic record or a state or federal data system that demonstrates that the individual meets the requirements of this regulation, the individual shall be considered to meet the requirements of this regulation, unless the: (1) Department or its designee has cause to question the documentation previously accepted; or (2) Federal government requires additional documentation. #### Regulation .05-2 Nonfinancial Eligibility Requirements — Emergency Medical Services for Ineligible or Illegal Aliens. *COMAR 10.09.24.05-2* A. An alien shall be eligible for federal Medical Assistance coverage of emergency medical services, as specified under §§B and C of this regulation, if the alien is determined by the Department to: (1) Have received emergency medical services described under §§B and C of this regulation that are necessary for treatment of an emergency medical condition; and (2) Meet all other requirements of Medical Assistance eligibility as specified in this chapter, including Maryland residency and financial eligibility, except the requirements related to: (a) Social Security number; and (b) Alien eligibility and declaration of immigration status. B. Emergency medical services, including labor and delivery services, are for the treatment of an emergency medical condition that, after a sudden onset, manifests itself by acute symptoms of sufficient severity, including severe pain, such that the absence of immediate medical attention can reasonably be expected to result in: (1) Placing the individual's health in serious jeopardy; (2) Serious impairment to bodily functions; or (3) Serious dysfunction of any bodily organ or part. C. Emergency medical services extend from when the individual enters a hospital to receive the emergency medical services until the individual's emergency medical condition or other medical condition requiring the emergency medical services is stabilized, as determined by the Department. D. Emergency medical services do not include: (1) An organ transplant and all services related to an organ transplant; or (2) Routine prenatal or postpartum care. #### Regulation .05-3 Nonfinancial Eligibility Requirements — Residency. *COMAR 10.09.24.05-3* A. To be eligible for the Maryland Medical Assistance Program, an applicant or recipient shall be a Maryland resident. B. An individual is a Maryland resident if the individual resides in Maryland with the intent of remaining permanently or for an indefinite period, regardless of whether the individual maintains the residence permanently or at a fixed address. C. Residency in a state begins on the day that an individual: (1) Enters the state with the intent to remain permanently or for an indefinite period; or (2) Decides to remain in the state permanently or for an indefinite period after entering for another purpose. D. An individual is not a resident of a state if the individual: (1) Is temporarily residing in or visiting the state without the intent of remaining, except as specified under §I(2)(b)(ii) or §I(3) of this regulation; (2) Came into the state for a specific, time-limited purpose and does not intend to remain, except as specified under §I(2)(b)(ii) or §I(3) of this regulation; or (3) Entered the state voluntarily to obtain noninstitutional medical care, such as for acute hospital inpatient services. E. Residency in a state established on any day in a calendar month shall constitute residency for the full month. F. Retaining Residency. (1) Residency is retained until abandoned. (2) Temporary absence from a state, with the intent to return to the state when the purpose of the absence is accomplished, does not interrupt continuity of residency, unless another state's Medical Assistance program determines that the individual is a resident of the other state. (3) An individual who is routinely absent from a state for a protracted period of time retains residency in that state if the individual: (a) Declares the intent to remain a resident of the state; (b) Has an established residential address in the state; and (c) Is not certified for Medical Assistance or receiving public assistance in another state. (4) Residency in a state is not affected by an absence for: (a) Unanticipated medical care; or (b) Out-of-state medical treatment preauthorized by the state's Medical Assistance Program. G. An individual is ineligible for a state's Medical Assistance Program for any month in which the individual is not a resident of the state. H. State Supplementary Payment for a Recipient of Supplemental Security Income (SSI). (1) Notwithstanding any other provisions of this regulation, the state of residence for a recipient of a state supplementary SSI payment is the state making the supplementary payment. (2) An individual receiving a state supplementary payment from another state who moves to Maryland with the intent of remaining in Maryland is not eligible for Maryland Medical Assistance until: (a) The individual's change of state residence is verified; and (b) Changes, if any, in the individual's payment amount are made with the Social Security Administration. I. Additional Residency Criteria for Noninstitutionalized Individuals. (1) Noninstitutionalized Child. (a) Except as otherwise specified in this regulation, a noninstitutionalized, unmarried individual younger than 21 years old is considered a resident of the state where the child lives: (i) With the child's parent or other caretaker relative; or (ii) In another living arrangement if the child is not living with the child's parent or other caretaker relative, and the child's parent or other caretaker relative is not responsible for the child's day-to-day care and supervision. (b) For a child receiving federal payments for foster care or adoption assistance under Title IV-E of the Social Security Act, the child's state of residence is the state where the child lives, even if it is not the state making the payments. (c) If a noninstitutionalized child's Medical Assistance eligibility is determined based on blindness or disability, the child's state of residence is the state where the child lives. (2) Noninstitutionalized Adult. A noninstitutionalized adult, including an individual younger than 21 years old who is married or otherwise emancipated from the individual's parents, is considered a resident of the state where the individual lives: (a) Voluntarily with the intent to remain permanently or for an indefinite period; or (b) At the time of Medical Assistance application, if the individual is: (i) Determined as incapable of indicating intent, in accordance with §K of this regulation; or (ii) Not receiving assistance from another state and entered the state with a job commitment or seeking employment, whether or not the individual is currently employed. (3) The exclusion of Medical Assistance eligibility under §D of this regulation for individuals who temporarily reside in the state without the intent of remaining shall be waived for members of an assistance unit that includes a migrant worker, in MAGI Exempt coverage groups. (4) Notwithstanding any other provision of this regulation, the state of residence for an individual placed by a state government in another state is the state that arranges or makes the placement for medical or other publicly funded services. J. Additional Residency Criteria for Institutionalized Individuals. (1) For an institutionalized adult, including an individual younger than 21 years old who is married or otherwise emancipated from the individual's parents, the state of residence is the state where the individual is institutionalized, if the individual indicates the intent to remain in the long-term care facility indefinitely. (2) If an institutionalized adult became incapable of indicating intent when the individual was 21 years old or older, the individual's state of residence is the state where the individual is institutionalized. (3) An institutionalized child younger than 21 years old, or an institutionalized adult who became incapable of indicating intent when younger than 21 years old, is a resident of the state in which the: (a) Individual's parent or other legal guardian resided at the time of the individual's placement in the long-term care facility; (b) Individual's parent or other legal guardian currently resides, who applied for Medical Assistance on the individual's behalf; or (c) Individual is institutionalized if the individual was abandoned by the individual's parents and does not yet have a legal guardian. (4) Notwithstanding any other provision of this regulation, the state of residence for an individual institutionalized by a state government in an out-of-state facility is the state that arranges or makes the placement. (5) The Department may not deny Medical Assistance eligibility to an institutionalized individual who satisfies the residency requirements of this regulation, on the grounds that the individual did not establish Maryland residency before entering the long-term care facility. K. An adult is considered incapable of indicating intent if the individual: (1) Has an Intelligence Quotient of 49 or less, or a mental age of 7 years old or younger, based on tests acceptable to the Department's Developmental Disabilities Administration; (2) Is judged legally incompetent; or (3) Is found incapable of indicating intent based on medical documentation obtained from a physician, psychologist, or other person licensed by the state in the field of intellectual disabilities. #### Regulation .05-4 Nonfinancial Criteria for MAGI Exempt Coverage Groups. *COMAR 10.09.24.05-4* A. Blindness. (1) To be eligible for Medical Assistance as a blind individual, an applicant or a recipient shall be blind as defined at Regulation .02 of this chapter. (2) Procedure for Determination of Blindness. (a) If an applicant's or recipient's eligibility for Medical Assistance is determined on the basis of blindness, an ophthalmologist or a licensed optometrist shall examine the individual, unless: (i) Both of the individual's eyes are missing; or (ii) The Social Security Administration has determined that the individual is currently blind. (b) The ophthalmologist or licensed optometrist shall submit a report of the examination to the local department of social services or other entity designated by the Department. (c) An ophthalmologist, contracted by the Department or its designee, shall review the report and determine, on behalf of the local department of social services or other entity designated by the Department: (i) Whether the individual meets the definition of blindness; and (ii) The need and frequency of reexamination for periodic redetermination of blindness. (3) Reexaminations for periodic redeterminations of blindness shall be conducted according to the procedures described under §B(2) of this regulation. (4) The local department of social services or other entity designated by the Department shall accept the Social Security Administration's determination of blindness for an individual receiving a Social Security benefit based on blindness. B. Disability. (1) In order to be eligible for Medical Assistance as a disabled individual, an applicant or recipient shall meet the definition of disabled in Regulation .02B of this chapter. (2) Procedure for Determination of Disability. (a) The Family Investment Administration shall determine disability. (b) The local department of social services shall obtain a medical report and other nonmedical evidence for an individual applying for Medical Assistance on the basis of disability. The medical report and nonmedical evidence shall include a diagnosis and other information in accordance with the requirements for evidence applicable to disability determinations under the Supplemental Security Income Program (SSI), specified under 20 CFR Part 416, Subpart I. (c) A Family Investment Administration review team shall review the medical report and other evidence obtained under §B(2)(b) of this regulation and determine whether the individual’s condition meets the definition of disability. The review team shall be composed of a medical or psychological consultant, and another individual who is qualified to interpret and evaluate medical reports and other evidence relating to the individual’s physical or mental impairments and, as necessary, to determine the capacities of the individual to perform substantial gainful activity as specified in 20 CFR Part 416, Subpart J. (3) Disability Determination Made by the Social Security Administration. (a) The Family Investment Administration may not make an independent determination of disability if the Social Security Administration has made a disability determination within 90 days of the date of the Medical Assistance application on the same issues presented in the Medical Assistance application. (b) A determination by the Social Security Administration is binding on the Family Investment Administration until it is changed by the Social Security Administration. If the Social Security Administration determination is changed, the new determination is binding on the Family Investment Administration. (c) The Department or its designee shall refer to the Social Security Administration for reconsideration or reopening of the determination all applicants who allege new information or evidence affecting previous Social Security Administration determinations of ineligibility based on disability, except as specified in §B(4)(d)(i) of this regulation. (4) Disability Determination made by the Family Investment Administration. The Family Investment Administration shall make a determination of disability if any of the following circumstances exists: (a) The individual applies for Medical Assistance and has not applied for SSI benefits; (b) The individual applied for SSI benefits and was found ineligible for a reason other than disability; (c) The individual has applied for both Medical Assistance and SSI benefits, and the Social Security Administration has not made an SSI determination within 90 days from the date of the individual’s application for Medical Assistance; (d) The individual has applied for Medical Assistance and: (i) Alleges a disabling condition different from, or in addition to, that considered by the Social Security Administration in making its determinations; (ii) Alleges more than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated since that determination and alleges a new period of disability that meets the durational requirements for disability, and has not applied to the Social Security Administration for a determination with respect to those allegations; (iii) Alleges less than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated and alleges a new period of disability that meets the durational requirements for disability, and has applied to the Social Security Administration for reconsideration or reopening of its disability decision but the Social Security Administration has refused to consider the new allegations; or (iv) Alleges less than 12 months after the most recent determination by the Social Security Administration denying disability that the individual’s condition has changed or deteriorated, alleges a new period of disability that meets the durational requirements for disability, and no longer meets the nondisability requirements for SSI, but may meet the State’s nondisability requirements for Medical Assistance eligibility. #### Regulation .05-5 Nonfinancial Eligibility Requirements — Institutions. *COMAR 10.09.24.05-5* A. Inmate of a Public Institution. (1) To be eligible for Medical Assistance, an applicant or recipient may not be incarcerated as an inmate of a public institution. (2) Inmate Status. (a) An individual is considered incarcerated as an inmate of a public institution if the individual resides in a public institution involuntarily as a result of being accused or found guilty of a criminal offense, including the duration of time in which the individual is involuntarily residing in the public institution in a preadjudication or pretrial status awaiting criminal proceedings, penal dispositioning, or other involuntary detainment procedure. (b) An individual may not be considered an inmate of a public institution if the individual resides in a public: (i) Institution voluntarily and not as the result of a legal criminal process; (ii) Educational or vocational training institution for the purpose of receiving educational or vocational training; or (iii) Institution for the first partial month of residence or for a temporary period pending other arrangements appropriate to the individual's needs. (c) Hospitalization as a Result of the Commission of a Crime. An individual who is hospitalized as a result of an injury sustained during the commission of a crime and has not yet been incarcerated because of the hospitalization may not be considered an inmate of a public institution. (d) Retaining Inmate Status. Except as provided in §A(2)(f) of this regulation, an individual's inmate status continues until the criminal indictment against the individual is dismissed or the individual is released from the public institution. (e) An individual who is not present at the correctional facility during the day, because the individual is attending a day treatment program or participating in day-time employment, but who resides in a correctional facility at night, shall be considered an inmate of a public institution. (f) Inmate Admitted to Medical Institution. An inmate may be covered by Medical Assistance during the period when the inmate is admitted as an inpatient of a medical institution, such as a hospital, nursing facility, or juvenile psychiatric facility, and is receiving services covered by Medical Assistance. (g) Individual Sent to an Institution for Mental Disease (IMD). (i) Inmate status shall apply to an individual who is accused of a criminal offense and is sent directly to an IMD either for a mental examination or because the individual is determined mentally incompetent to stand trial. (ii) An individual committed by a court to an IMD based on a verdict of not guilty by reason of insanity may not be considered an inmate of a public institution. (3) Children Younger than 21 Years Old Committed to a Correctional Facility. (a) A child committed by a court to a correctional institution due to a violation of the law shall be considered incarcerated as an inmate of a public institution. (b) A child committed to the custody of the Maryland Department of Juvenile Services shall be considered incarcerated as an inmate of a public institution if the child is placed in a State-owned and State-operated facility, and that status shall continue until the child is released from the facility. (c) A child committed to the custody of the Maryland Department of Juvenile Services may not be considered an inmate of a public institution if the child is living: (i) With the child's parent, caretaker relative, or legal guardian; (ii) In a group home serving no more than 16 residents; or (iii) In a privately operated facility under the jurisdiction of the Maryland Department of Juvenile Services. B. Institution for Mental Disease (IMD). (1) An institutionalized individual younger than 65 years old who is admitted for residence in an institution for mental disease is not eligible for Medical Assistance, unless the applicant or recipient is: (a) Younger than 22 years old; and (b) Receiving inpatient psychiatric services for individuals younger than 21 years old. (2) Inpatient psychiatric services for individuals younger than 21 years old may be provided: (a) To individuals who are younger than 21 years old; or (b) Until the earlier of the date that the individual: (i) No longer requires the services; or (ii) Is 22 years old, if the individual was receiving the services immediately before reaching 21 years old. (3) Except as provided in §B(4) of this regulation, when an individual is on conditional release or convalescent leave from an IMD, the individual may not be considered institutionalized in the IMD. (4) An individual who is receiving inpatient psychiatric services for individuals younger than 21 years old shall be considered an institutionalized individual until the earlier of the date that the individual: (a) Is unconditionally released from the IMD; or (b) Is 22 years old. #### Regulation .06 MAGI Exempt Assistance Unit. *COMAR 10.09.24.06* A. Purpose and Scope. This regulation establishes who shall be a member of an assistance unit, who may be excluded from an assistance unit, who will have separate eligibility determinations, and whose income and resources will be considered in determining financial eligibility for MAGI Exempt applicants and recipients of Medical Assistance. A-1. More Than One Assistance Unit Among Individuals Living Together. More than one assistance unit is permissible if: (1) The parent or other caretaker relative chooses to have a child's eligibility determined as blind or disabled under Regulation .04J of this chapter; (2) A caretaker relative chooses to have his eligibility determined as aged, blind, or disabled under Regulation .04J of this chapter; and (3) There are individuals who would have been members of the assistance unit except for their status as automatically eligible Medical Assistance recipients under Regulation .03B of this chapter. A-2. Separate Eligibility Determinations for Certain Individuals. (1) An individual eligibility determination shall be conducted for each individual identified in §A-1(1) of this regulation who requests Medical Assistance. (2) For the aged, blind, or disabled individual identified in §A-1(2) of this regulation: (a) If the person chooses to have eligibility determined as aged, blind, or disabled and either the person's spouse is non-aged, blind, or disabled or the aged, blind, or disabled spouse chooses to have eligibility determined as a caretaker relative, an individual eligibility determination shall be conducted; or (b) If the person applies as aged, blind, or disabled and the person's spouse also applies as aged, blind, or disabled, the couple will be considered one unit. B. Aged, Blind, or Disabled. (1) This section is applicable to the following: (a) An aged, blind, or disabled person 21 years old or older who has no unmarried related children younger than 21 years old living with him; (b) An aged, blind, or disabled person and spouse, with no unmarried related children younger than 21 years old living with the couple; (c) A blind or disabled child younger than 21 years old who chooses to have his eligibility determined as blind or disabled; and (d) An aged, blind, or disabled caretaker relative who chooses to have his eligibility determined as aged, blind, or disabled. (2) Composition—Aged, Blind, or Disabled. (a) The assistance unit shall include the following persons, except as provided in §B(2)(b)—(c) of this regulation: (i) The aged, blind, or disabled person; and (ii) The aged, blind, or disabled spouse of the aged, blind, or disabled person, when living together. (b) An aged, blind, or disabled caretaker relative who chooses to apply as caretaker relative will not be included in the unit. (c) A non-aged, blind, or disabled parent or caretaker relative other than parent will not be included in the unit. (3) Income and Resource Consideration. (a) In determining financial eligibility, the income and resources of the following persons shall be considered: (i) All persons included in the assistance unit; (ii) The spouse of the applicant, when living together, unless the spouse is an SSI recipient; and (iii) The parent of a blind or disabled child younger than 18 years old, when living together, unless the parent is an SSI recipient. (b) Treatment of Income and Resources of Persons Not Living Together. (i) When spouses cease to live together, their income and resources shall be considered available to each other throughout the month in which they cease living together. Beginning with the first full month of separate residence, only actually contributed income and resources from the spouse shall be counted. (ii) When a blind or disabled child younger than 18 years old ceases to live with his parent, the income and resources of the parent shall be considered available throughout the month in which they cease living together. Beginning with the first full month of separate residence, only actually contributed income and resources from the parents shall be counted. C. Blind and Disabled Children Living With Parents or Other Caretaker Relatives. (1) This section applies to blind or disabled children living with a caretaker relative who chooses to have the child's eligibility determined as an individual younger than 21 years old and an aged, blind, or disabled individual who chooses to have his eligibility determined as a caretaker relative. (2) Persons Living Together. The unit shall be established on the basis of persons living together, including persons who are temporarily absent from the home for purposes of attending school, or pursuing vocational or job training. (3) Composition — Children Living With Parents or Other Caretaker Relatives. The assistance unit shall include, except as provided in §§A-1 and C(4) of this regulation, the parents, caretaker relatives other than parents, their unmarried children younger than 21 years old, and any other unmarried children younger than 21 years old (including second generation children who are parented by an unmarried person younger than 21 years old) who are related by blood, marriage, or adoption to the parent or caretaker relative other than parent. The relationship between children and caretaker relatives other than parents shall be limited to those specified in Regulation .02B(10)(a) of this chapter. (4) Exclusion of a Child or Caretaker Relative Other Than Parent. (a) The provisions of §C(3) of this regulation may not apply when: (i) A parent or caretaker relative other than a parent chooses to exclude a child from the assistance unit provided at least one child is in the unit and the exclusion does not cause the applicant or recipient to lose Medical Assistance (Title XIX) status as a caretaker relative as defined in Regulation .02B(10)(a) of this chapter. (ii) A caretaker relative other than a parent chooses to be excluded from the assistance unit. The choice of exclusion includes the caretaker relative's spouse. (b) An excluded aged, blind, or disabled person retains the option of selecting any federal category in which technical eligibility may be established upon subsequent application. (c) An excluded non-aged, blind, or disabled person may not have a separate eligibility determination. (5) Subsequent Application for an Excluded Person. (a) A person excluded from the assistance unit may apply for Medical Assistance. (b) If an excluded person applies as aged, blind, or disabled, the following conditions apply: (i) A separate eligibility determination will be made in accordance with §A-1 of this regulation; and (ii) Income and resources of a spouse or parent will be considered in accordance with §B(3) of this regulation. (c) If an excluded person does not apply as aged, blind, or disabled, the following conditions apply: (i) The period under consideration will be the same as that of the currently eligible assistance unit; (ii) Eligibility for the new member shall be determined in conjunction with the currently eligible assistance unit established in §C(3) of this regulation; (iii) The income and resources of the new member shall be added to that of the currently eligible assistance unit beginning with the month for which coverage of the new member is requested; (iv) The income of the new member may not be averaged to include any months before the month for which coverage is requested; (v) Certification may not begin earlier than the date the new member becomes eligible; and (vi) A decision of ineligibility for the new member will not affect the eligibility status of the currently eligible assistance unit for the remainder of the certification period. (6) Income and Resource Consideration. (a) In determining financial eligibility, the income and resources of the following persons shall be considered: (i) All persons included in the assistance unit; (ii) The spouse of the applicant, when living together, unless the spouse is an SSI recipient; and (iii) The parent of a child younger than 21 years old, when living together, unless the parent is an SSI recipient. (b) Treatment of Income and Resources When a Child Leaves the Home. The income and resources of a parent shall be considered throughout the month in which a child leaves the home for the purpose of establishing a new address, when the separation is for reasons other than placement in a foster home, group home, or drug or alcohol abuse treatment center. Beginning with the first full month of separate residence, only actually contributed income and resources from the parent shall be counted. D. Additions to the Household. A new member of the household will be considered in accordance with all applicable regulations of this chapter. #### Regulation .06-1 MAGI Household Unit. *COMAR 10.09.24.06-1* A. Purpose and Scope. (1) This regulation establishes who shall be a member of the MAGI household and who will be excluded from the MAGI household. (2) The regulation applies to applicants and recipients of coverage groups described under Regulation .03A of this chapter. B. Household Composition. (1) An individual, plus anyone for whom the individual claims a personal exemption, shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made. (2) For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: (a) Spouse; and (b) Natural, adopted or step children. (3) For a child applicant the household size shall consist of the child and the following individuals: (a) Natural, adopted, or step parents; and (b) Natural, adopted, or step siblings. (4) In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return. (5) In the case of determining the household size of a pregnant woman, the pregnant woman shall be counted as herself plus the number of children she is expected to deliver. #### Regulation .07 Consideration of Income. *COMAR 10.09.24.07* A. This regulation contains the rules for considering earned and unearned income of: (1) Members of the MAGI household unit and those individuals whose income is considered pursuant to Regulation .06-1 of this chapter in determining financial eligibility of individuals for retroactive and current eligibility for the period under consideration; or (2) Members of the MAGI exempt assistance unit and those individuals whose income and resources are considered pursuant to Regulation .06 of this chapter in determining financial eligibility of an assistance unit for retroactive and current eligibility for the period under consideration. B. Definitions. (1) “Disregard” means the amount of money specified by regulation that can be subtracted from countable income. (2) “Excludable income” means income which is exempt from consideration as countable income. (3) “Federal Supplemental Nutrition Assistance Program (SNAP)”, formerly the Food Stamp Program, has the meaning stated in COMAR 07.03.17.01. (4) “Income tax” means federal, state, or local taxes either paid or withheld from income of a self-employed person not to exceed the tax table amount for the number of known dependents. (5) “Modified Adjusted Gross Income (MAGI) based income” means income calculated using the same financial methodologies used to determine modified adjusted gross income as defined in 42 CFR 435.603 , with the following exceptions: (a) An amount received as a lump sum is counted as income only in the month received; (b) Scholarships, awards, or fellowship grants used for education purposes and not for living expenses are excluded from income; and (c) American Indian or Alaska Native exceptions in accordance with 42 CFR 435.603. C. The applicant shall report all income. When there is evidence of regular expenditures which are inconsistent with reported income, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. D. The Department or its designee shall consider all income in accordance with this regulation. E. Retroactive Eligibility. The income to be considered is that which was actually available during the retroactive period under consideration. F. Current Eligibility. In considering income for current eligibility, the following rules apply: (1) When an individual has regular income in the MAGI coverage group, the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application; (2) When an individual has a regular income in the MAGI Exempt coverage group, the amount to be considered is that which is available, or can reasonably be expected to be available, for a projected period of 6 months including the month of application; (3) For participants currently enrolled in both the Program and SNAP: (a) The Program may renew the individual’s Medicaid eligibility using household income as determined by SNAP without conducting a separate income determination; and (b) An individual is determined eligible when the participant is: (i) Younger than 19 years old and has a SNAP verified income at or below 200 percent of the federal poverty level for individuals in a MAGI coverage group; (ii) Younger than 19 years old and has a SNAP verified income at or below 300 percent of the federal benefit rate for individuals in a MAGI exempt coverage group; or (iii) Between 19 to 64 years old and has a SNAP verified income at or below 138 percent of the federal poverty level for individuals in a MAGI coverage group; (4) When a member of a MAGI exempt assistance unit works for less than 12 months but receives an annual salary, is self-employed, or has irregular or seasonal earning, the amount to be considered is one-half the expected annual income based on the prior year's gross income; and (5) For a deceased individual, the income to be considered is that which was available up to and including the month of death. When there are other individuals in the assistance unit or MAGI household unit, the deceased individual's income will be averaged over the unit's established period under consideration. G. Treatment of Income. (1) All earned and unearned income which is not designated as excludable income pursuant to §J of this regulation shall be counted to establish countable gross income. (2) Countable gross income for MAGI Exempt coverage groups shall be reduced by subtracting appropriate income disregards as specified in §K of this regulation to determine countable net income. (3) Countable gross income for MAGI coverage groups shall be the household income calculated according to MAGI. (4) MAGI income limits shall be: (a) Converted from traditional income limits to account for elimination of income disregards; and (b) Increased by 5 percentage points of the federal poverty level for the following circumstances: (i) When an individual’s income exceeds the Medicaid income standard; and (ii) The income standard is the highest income standard under which the individual can be determined eligible. H. Earned income includes the following: (1) Wages. (2) Commissions and fees. (3) Salaries and tips. (4) The value of in-kind goods and services received as a result of employment. (5) Profit from self-employment income of MAGI exempt coverage groups, as described in §K(3)(a)of this regulation. (6) Remuneration received for work or for activities performed as a participant in a program conducted by a sheltered workshop or activities center. (7) The Earned Income Tax Credit (EITC) a person receives through the Tax Reduction Act of 1973. (8) Sick pay which counts as earnings for deduction purposes under Title II of the Social Security Act. (9) Work study earnings. I. Unearned income includes the following: (1) Benefits and income from: (a) Social Security; (b) Veterans Administration; (c) Workmen's Compensation Board; (d) Black Lung Program; (e) Railroad Retirement Board; (f) Government, private, or company pensions and annuities; (g) Unemployment benefit plans; (h) Unemployment supplemental benefit plans; (i) Payments from oil or mineral rights (leases); (j) Government payments on land; (k) Insurance benefits paid directly to a person; (l) Trust funds; (m) Individual Retirement Accounts (IRA's); (n) Keogh Plans; (o) Military allotments. (2) Alimony, court-ordered and voluntary support payments received from an absent spouse, or an absent natural or adoptive parent. (3) Financial contributions received from persons or public or private agencies. (4) In-kind Support—Aged, Blind, or Disabled. (a) One-third the appropriate medically needy income level for the number of persons in an aged, blind, or disabled assistance unit, when: (i) A person receives in-kind support in the form of food and shelter while living in the household of another, and (ii) The person pays less than his pro rata share of the total household expenses for food and shelter, unless he documents otherwise. (b) The value of actual payments for food, shelter, or both made by other persons on behalf of the assistance unit. (c) The fair market value of free shelter received while living in an independent dwelling unit. When the person fails to present evidence of the fair market value of the dwelling unit, the presumed value shall be 1/3 the appropriate medically needy income level for the number of persons in the assistance unit. (d) This provision may not apply to persons residing in public or private institutions, foster homes, group homes, or commercial establishments. (5) Interest, dividends, royalties, or other income accrued to stocks, bonds, insurance, and savings certificates if the income is available to the person on a regular basis. (6) Interest or dividends accrued to savings accounts. (7) Mortgage payments. (8) Lump sum benefits or other amounts of income received on a one-time-only basis including gifts, inheritances, retroactive benefit payments, lottery winnings, damage claims unless specifically excluded by other regulations, or any other lump sums or portions of them that are not excluded under §J or K of this regulation. (9) Profit from Rental Income as described in §§L(3)(b) and M(2)(c)(ii) of this regulation. (10) Cash assistance received from nongovernmental social agencies unless excluded under the provisions of §J or §K of this regulation. (11) Grants, loans, scholarships, and fellowships for educational purposes, except as specified in §J(3) and (9) of this regulation. (12) Cash assistance, including Public Assistance grants and SSI benefits, except as specified in Regulation .06B(3)(a)(ii) and .06C(4)(a)(ii) of this chapter. (13) Sick pay which does not count as earnings for deduction purposes under Title II of the Social Security Act. J. Excludable Income—Aged, Blind, or Disabled. Income from the following sources shall be excluded in determining countable gross income: (1) The value of the coupon allotment under the Food Stamp Program. (2) Payment received under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, 42 U.S.C. §4601 et seq., excluding compensation received for the fair market value of the acquired real property. (3) Grants or loans to an undergraduate student for educational purposes made or insured under any program administered by the Secretary, U.S. Department of Education. (4) Work-study earnings, work-study stipends, and reimbursement for out-of-pocket expenses of a student. (5) Benefits received under Title III C Nutrition Program for the Elderly of the Older Americans Act of 1965, as amended. (6) Stipends, compensation, or expenses received by volunteers from a program existing or to be set up under the “Domestic Volunteer Service Act of 1973” sponsored by ACTION, such as but not limited to: (a) (PLS) Demonstration Project Program for Local Services; (b) VISTA (Volunteers in Service to America); (c) UYA (University Year for Action); (d) RSVP (Retired Senior Volunteer Program); (e) Foster Grandparents; (f) Older American Community Service Program; (g) SCORE (Service Corps of Retired Executives); and (h) ACE (Action Corps of Executives). (7) The value of supplemental food assistance received under the Child Nutrition Act of 1966 as amended, and the special food service program for children under the National School Lunch Act, as amended. (8) The value of livestock and home produce used for own consumption. (9) Educational Expenses. (a) The portion of educational grants, loans, scholarships, and fellowships that is designated and used solely for undergraduate and graduate educational pursuits such as tuitions, books, mandatory fees, transportation to and from educational institutions, and the cost of child care while in attendance. (b) These expenses may be allowed to the extent that there are insufficient funds from those grants and loans specified under §J(3) of this regulation to cover these expenses. (10) The earned income of a blind or disabled child who is younger than 22 years old and regularly attending school, including a college, university, or vocational training school, not to exceed $1,620 a calendar year. (11) Payments received from providing foster care or subsidized adoption services to a child placed in the home by a public or private nonprofit child placement or child care agency. (12) Assistance provided in cash or in-kind under the Emergency Energy Conservation Services Program, including plans for crisis intervention to prevent fuel cut-offs and assistance provided under the Low-Income Home Energy Assistance Act. (13) The value of rent subsidies or other assistance received by a person for his dwelling unit under: (a) The U.S. Housing Act of 1937, 42 U.S.C. §§1400 et seq.; (b) The National Housing Act, 12 U.S.C. §§1701 et seq.; (c) Section 101 of the Housing and Urban Development Act of 1965, 42 U.S.C. §§1400 et seq.; (d) Title V of the Housing Act of 1949, 12 U.S.C. §§1601 et seq.; 42 U.S.C. §§1400 et seq. (14) Infrequent or Irregular Earned Income. Infrequent or irregular earned income shall be excluded if: (a) The total gross amount does not exceed $30 per quarter; and (b) It is received less frequently than twice per quarter or cannot be reasonably anticipated. (15) Infrequent or Irregular Unearned Income. Infrequent or irregular unearned income shall be excluded if: (a) The total amount does not exceed $200 per 6 months; and (b) It is received less frequently than twice per quarter or cannot be reasonably anticipated. (16) The value of earned and unearned in-kind income. (17) Third-party payments for food, clothing, shelter, or other goods and services made on behalf of an assistance unit or other persons whose income and resources are considered in determining eligibility, if the payment is not reimbursement for services rendered by a member of the assistance unit or other persons whose income and resources are considered. (18) The Earned Income Tax Credit (EITC) a person receives through the Tax Reduction Act of 1973. (19) Reparation payments made by the Federal Republic of Germany. (20) For recipients of a VA pension who have neither spouse nor child, the VA payment not to exceed $90 per month beginning the month after the month of admission to a long-term care facility. (21) Cash, including interest earned on the cash, or in-kind replacement received from any source for purposes of repairing or replacing an excluded resource that is lost, damaged, or stolen is not income but continues to be considered as an excluded resource in accordance with the provisions of Regulation .08G(7) of this chapter. (22) Assistance, including any interest earned on the assistance, received under the Disaster Relief Act of 1974 (PL 93-288) or other assistance provided under a federal statute because of a catastrophe which is declared to be a major disaster by the President of the United States is not income but an excluded resource. (23) Support and Maintenance (In-Kind Income) Provided as Replacement for an Excluded Home Because of a Casualty Loss or a Presidentially Declared Major Disaster. (a) When an excluded home is damaged or destroyed and temporary housing is furnished to a person who owned an excluded home, the in-kind support and maintenance is not counted as income. This temporary housing is intended to replace the home pending repair or replacement of the excluded home. (b) When an excluded home is damaged or destroyed as a result of a presidentially declared major disaster, the value of support and maintenance (in cash or in-kind) received by a person, or couple, is excluded, if: (i) The person, or couple, was residing in the household as a home when a catastrophe occurred in the area in which the home was located; (ii) The catastrophe was declared by the President to be a major disaster for purposes of the Disaster Relief Act of 1974; (iii) The person, or couple, stopped living in the home because of the catastrophe and, within 30 days after the catastrophe, began to receive the support and maintenance; and (iv) The person, or couple, received the support and maintenance while living in a residential facility, including a private home, maintained by another person. (24) Any amount refunded from any public agency, if paid on the purchase of food or the satisfaction of real property levies. (25) One-third of support payments made to or for a blind or disabled child by an absent parent. (26) Interest income accrued to a: (a) Bank account during the period under consideration, such as a checking, savings, or money market account; (b) Dedicated bank or other financial institution account that is considered an excludable resource because it is unavailable, such as an escrow account for a security deposit; or (c) Keogh account, individual retirement account (IRA), or other private retirement account that is countable as a resource. (27) Interest payments received for a mortgage, promissory note, or other loan. (28) Refund of taxes on income, property, food, or other items already paid. (29) Proceeds of a loan received by an individual as the borrower. (30) Payments received from a trust, if the trust is countable as a resource. (31) Income from the sale of an assistance unit member's blood or plasma. (32) Cash donations based on need received from one or more charitable organizations. (33) All income excluded by federal statute for medical assistance programs. K. Disregards — Aged, Blind, or Disabled. In order to determine countable net income, the following disregards shall be deducted from the countable gross income of an aged, blind, or disabled assistance unit: (1) A general disregard of $20 per month for a person or a couple. (2) An earned income disregard of $65 per month plus one-half of the remainder of the earned income of a person or a couple. (3) A disregard of one-half of the gross income amount for the following types of income: (a) Profit from self-employment income, unless an applicant or recipient can document a cost to produce in excess of the disregard of one-half of gross income; and (b) Profit from rental property income and other income-producing property. (4) The amount of earned income used to meet any expenses reasonably attributable to earning of income of a blind person younger than 65 years old in accordance with 20 CFR §416.1112(c)(5). (5) Any wages, allowances, or reimbursement for transportation and attendant care costs, unless excepted on a case-by-case basis, when received by a blind or disabled handicapped person employed in a project under Title VI of the Rehabilitation Act of 1973 as added by Title II of Pub. L. No. 95-602 (92 Stat. 2992, 29 U.S.C. §795(b)(c)). L. Schedule MA-1. #### Regulation .08 Consideration of Resources for MAGI Exempt Coverage Groups. *COMAR 10.09.24.08* A. This regulation contains the rules for considering resources of members of the MAGI exempt assistance unit and those individuals whose income and resources are considered pursuant to Regulation .06 of this chapter in determining financial eligibility of an assistance unit for retroactive and current eligibility for the period under consideration. B. Definitions. (1) “Account” means cash savings or any other form of liquid resource in a bank, credit union, savings and loan association, or any other financial institution in which the resource is subject to withdrawal by the owner or owners of the account. (2) Automobile. (a) “Automobile” means a passenger car or any other vehicle used to provide necessary transportation. (b) “Automobile” does not mean an airplane, farm machinery, or a vehicle used solely for recreational purposes. (3) “Burial funds” means a revocable burial contract, burial trust, or other burial arrangement or any other separately identifiable fund which is clearly designated as set aside for a person's burial expenses. (4) “Burial spaces” means conventional gravesites, crypts, mausoleums, urns, and other repositories which are customarily and traditionally used for the remains of deceased persons. (5) “Equity value” means the fair market value of property less any legal debt on the property. (6) “Fair market value” means the amount for which property can be sold on the open market in a particular geographical area. (7) “Funds in an irrevocable trust or other irrevocable arrangement that are available to meet burial expenses” means funds which are held in an irrevocable burial contract, an irrevocable burial trust, or an amount in an irrevocable trust which is specifically identified as available for burial expenses. (8) “Home” means any shelter in which a member of the assistance unit or any person whose income and resources are considered in determining the financial eligibility of the assistance unit, has an ownership interest and uses as his principal place of residence. The home includes the parcel of land on which the shelter is situated and any related outbuildings necessary to its operation. Only one residence may be considered home property. (9) “Immediate family” means a person's spouse or a person's minor and adult children, including adopted children and stepchildren, or a person's brothers, sisters, parents, adoptive parents, and the spouses of these persons. Neither dependency nor living in the same household are factors in determining whether a person is an immediate family member. (10) “Institutionalized person” means a person who is: (a) An inpatient in a nursing facility; (b) An inpatient in a medical institution and with respect to whom payment is made based upon a level of care provided in a nursing facility; or (c) Receiving services under a home and community-based services waiver under COMAR 10.09.27 or 10.09.31. (11) “Joint account” means an account in which two or more persons are named as owners of the account and the funds in the account are subject to withdrawal by any of the persons named as owners. (12) “Medicaid qualifying trust” means a trust or similar legal device established on or before August 10, 1993, other than by will, by an individual or an individual's spouse, under which the individual or the individual's spouse may be the beneficiary of all or part of the payments from the trust, and the distribution of payment is determined by one or more trustees who are permitted to exercise any discretion with respect to the distribution to the individual. (13) “Nonapplicant” means a person who is neither an applicant nor the spouse of an applicant. (14) Property. (a) “Property” means any thing or things in which a person has a legal or equitable interest. (b) “Personal property” means all property that is not real property. (c) “Real property” means property which is fixed or immovable such as land or a building. (15) “Uncompensated value” means the difference between the fair market value of a person's interest in a resource at the time it was disposed of and the amount of compensation received for the resource. C. The applicant shall report all resources to the Department or its designee with the exception of non-disabled children and their caretaker relatives who are not being considered as medically needy. D. Countable income that is retained at redetermination or reapplication shall be considered a resource unless specifically excluded by other regulations. E. The Department or its designee shall require an accounting and reasonable documentation, consisting of convincing testimony or other evidence, of the disposal of previously held resources within 30 months before the month of application to assure that the resources are no longer available and the disposal meets the requirements of this regulation. F. Excludable Resources for Aged, Blind, or Disabled Noninstitutionalized Individuals and Aged, Blind, or Disabled Institutionalized Individuals Who Intend to Return Home. The following resources are excluded in determining financial eligibility for aged, blind, or disabled noninstitutionalized individuals and for an aged, blind, or disabled institutionalized individual who intends to resume living in the individual's home: (1) The home, as defined under §B(7) of this regulation, unless the person is institutionalized and has a life estate interest with full powers in the home. (2) Income-Producing Property. (a) Income-producing property associated with the home includes farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. The property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §F(2)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. (b) Income-producing property not associated with the home includes land, buildings, farm machinery, business equipment, vehicles, special tools, farm animals and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §F(2)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. (c) $6,000 Equity Value Exclusion. A $6,000 equity value exclusion applies to the combined equity value of resources in §F(2)(a) and (b) of this regulation. The exclusion does not apply to each individual property. (d) Limitations on Equity Value Exclusion. (i) The full equity value of each property not producing a net annual return of 6 percent will be a countable resource. (ii) The combined equity value in excess of $6,000 of all properties producing an individual net annual return of 6 percent will be a countable resource. (3) Household Goods and Personal Effects. (a) Household Goods. (i) Household goods include those items of personal property customarily found in the home and used in connection with the maintenance, use, and occupancy of the premises as a home and in the functions and activities of home and family life, as well as those items which are for comfort and accommodation. (ii) Household goods necessary for the maintenance, use, and occupancy of the home shall be excluded regardless of value. The equity value of nonessential items shall be added to other countable resources and measured against the applicable resource standard. (b) Personal Effects. (i) Personal effects include those items of personal property which are worn or carried by a person or have an intimate relation to him. (ii) Personal effects shall be excluded except as specified in §F(3)(b)(iii) of this regulation. (iii) The equity value of nonessential personal effects of considerable value such as furs, and jewelry which is not excluded in §F(3)(c) of this regulation, shall be added to other countable resources and measured against the applicable resource standard. (c) A wedding ring and an engagement ring shall be excluded from consideration as resources. (d) Prosthetic devices, dialysis machines, hospital beds, wheelchairs, and similar equipment required because of a person's physical condition shall be excluded from consideration as resources. (e) For an institutionalized person, household goods and personal effects remaining in the possession of the person at the long-term care facility shall be excluded from consideration as resources. (4) Livestock and farm produce that is used only for home consumption. (5) Automobiles. (6) Life Insurance with a Maximum Face Value of $1,500 for Each Person. (a) Life insurance policies such as term or burial insurance which do not have a cash surrender value may not be used in determining the total face value of all policies. (b) Whenever the total face value of all policies on any person exceeds the allowable maximum face value, the entire cash surrender value of these policies shall be counted as a resource. Cash surrender value includes available accrued dividends and interest. (7) Cash and In-Kind Replacement Received for Casualty Losses of Excluded Resources. (a) Cash, including interest earned on the cash, or in-kind replacement received from any source for the purpose of replacing an excluded resource that is lost, damaged, or stolen, shall be an excluded resource for a period of 9 months, beginning with the date the cash or in-kind replacement was received. (b) The initial 9-month exclusion period specified in §F(7)(a) of this regulation shall be extended for a reasonable period up to an additional 9 months if circumstances beyond the control of the individual prevent him from repairing, replacing, or contracting for the repair or replacement of the resource. (c) Any of the cash and interest or in-kind replacement that is not used to repair or replace the excluded resource shall be counted as a resource beginning with the period under consideration after expiration of the initial 9-month period, or the extended period, if any. (d) If an extension of the time period is made pursuant to §F(7)(b) of this regulation and the individual changes his intent to repair or replace the excluded resource, cash and interest, or in-kind replacement previously excluded, shall be counted as resources effective with the month the individual reports his change of intent. (8) Assistance Received Because of a Major Disaster. (a) Assistance, including any interest earned on the assistance, received under the Disaster Relief Act of 1974 (PL 93-288) or other assistance provided under a federal statute because of a catastrophe which is declared to be a major disaster by the President of the United States shall be excluded in determining countable resources for a period of 9 months from the date of receipt. (b) The initial 9-month period for not counting the assistance specified in §G(8)(a) of this regulation shall be extended for a reasonable period up to an additional 9 months if circumstances beyond the control of the person prevented him from repairing, replacing, or contracting for repair or replacement of damaged or destroyed property. (9) Burial spaces for a person and the person's immediate family. (10) Proceeds from Sale of a Home. Proceeds from the sale of a home shall be excluded from consideration as a resource for a period not to exceed 3 months from the date the proceeds are received if the: (a) Person indicates he intends to replace the home during that period; (b) Home is in fact replaced during that period; and (c) Replaced home itself was an excluded resource under the provision of §F(1) of this regulation. (11) Payment received under the Uniform Relocation Assistance and Real Property Acquisition Policies Act of 1970, 42 U.S.C. §4601 et seq. Compensation received for the fair market value of the acquired real property is not subject to this regulation. (12) Assistance provided in cash or in-kind under the Emergency Energy Conservation Services Program, including plans for crisis intervention to prevent fuel cut-offs and assistance provided under the Low-Income Home Energy Assistance Act. (13) Burial Funds. (a) In determining the resources of a person and the person's spouse, if any, there shall be excluded an amount up to $1,500 per person of funds specifically set aside for burial arrangements of the person or the person's spouse. (b) Interest earned on excluded burial funds and appreciation on the value of excluded burial arrangements shall be excluded from resources if left to accumulate and become a part of the burial fund. (c) Funds or interest earned on funds and appreciation in the value of burial arrangements, which have been excluded from resources because they are burial funds, shall be used solely for that purpose. (d) If any excluded funds, interest, or appreciated value set aside for burial expenses are used for any purpose other than the burial arrangements of the person or the person's spouse for whom the funds were set aside, the unit shall be determined ineligible until the unit spends for medical services an amount which is equal to the amount of burial funds used for some other purpose. (e) §F(13)(d) of this regulation may not apply if countable resources, when added to the total excluded burial funds, including the amount misspent, were within the applicable amount in Schedule MA-2 during the month in which the use of burial funds for some other purpose occurred. (f) An individual's $1,500 exclusion as described under §F(13)(a) of this regulation shall be reduced by: (i) The face value of life insurance policies owned by the individual or the individual's spouse if the cash surrender value of those policies has been excluded from resources; and (ii) Amounts in an irrevocable burial fund as described under §F(14) of this regulation. (14) An irrevocable burial fund of any amount, which has been set aside for the burial of the individual or the individual's spouse. G. Excludable Resources for Aged, Blind, or Disabled Institutionalized Individuals Who Do Not Intend to Return Home. The following resources are excluded in determining financial eligibility for an aged, blind, or disabled institutionalized individual who does not intend to resume living in the individual's home: (1) The home as defined in §B(4) of this regulation, if it is occupied by the institutionalized person's spouse or any one of the following relatives who are medically or financially dependent: (a) Son; (b) Daughter; (c) Grandson; (d) Granddaughter; (e) Stepson; (f) Stepdaughter; (g) In-laws; (h) Mother; (i) Father; (j) Stepmother; (k) Stepfather; (l) Half sister; (m) Half brother; (n) Niece; (o) Nephew; (p) Grandmother; (q) Grandfather; (r) Aunt; (s) Uncle; (t) Sister; (u) Brother; (v) Stepbrother; (w) Stepsister. (2) Household Goods and Personal Effects Remaining in the Possession of the Person at the Long-Term Care Facility. (a) Household goods include those items of personal property which are customarily found in the home and used in connection with the maintenance, use, and occupancy of the premises as a home and in the functions and activities of home and family life, as well as those items which are for comfort and accommodation. (b) Personal effects include those items of personal property which are worn or carried by a person or have an intimate relation to him. (c) Household goods and personal effects include, but are not limited to, items of personal clothing, toilet articles, prosthetic devices, an engagement ring, and a wedding ring. (3) Life Insurance with a Maximum Face Value of $1,500 for Each Person. (a) Life insurance policies such as term or burial insurance which do not have a cash surrender value may not be used in determining the total face value of all policies. (b) Whenever the total face value of all policies exceeds the allowable maximum face value, the entire cash surrender value of these policies shall be counted as a resource. Cash surrender value includes all available accrued dividends and interest. (4) Burial spaces for a person and the person's immediate family. (5) Income-Producing Property. (a) Income-producing property associated with the home includes farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §G(5)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. (b) Income-producing property not associated with the home includes land, buildings, farm machinery, business equipment, vehicles, special tools, farm animals, and livestock related to self-support activities. This property shall be excluded if the total equity value of these resources does not exceed the limit set forth in §G(5)(c) of this regulation and the resource produces a net annual return of at least 6 percent of the equity. (c) $6,000 Equity Value Exclusion. A $6,000 equity value exclusion applies to the combined equity value of resources in §G(5)(a) and (b) of this regulation. The exclusion does not apply to each individual property. (d) Limitations on Equity Value Exclusion. (i) The full equity value of each property not producing a net annual return of 6 percent will be a countable resource. (ii) The combined equity value in excess of $6,000 of all properties producing an individual net annual return of 6 percent will be a countable resource. (6) Burial Funds. (a) In determining the resources of a person and the person's spouse, if any, there shall be excluded an amount up to $1,500 per person of funds specifically set aside for burial arrangements of the person or the person's spouse. (b) Interest earned on excluded burial funds and appreciation on the value of excluded burial arrangements shall be excluded from resources if left to accumulate and become a part of the burial fund. (c) Funds or interest earned on funds and appreciation in the value of burial arrangements, which have been excluded from resources because they are burial funds, shall be used solely for that purpose. (d) If any excluded funds, interest, or appreciated value set aside for burial expenses are used for any purpose other than the burial arrangements of the person or the person's spouse for whom the funds were set aside, the unit shall be determined ineligible until the unit spends for medical services an amount which is equal to the amount of burial funds used for some other purpose. (e) Section G(6)(d) of this regulation may not apply if countable resources, when added to the total excluded burial funds, including the amount misspent, were within the applicable amount in Schedule MA-2 during the month in which the use of burial funds for some other purpose occurred. (f) An individual's $1,500 exclusion as described under §G(6)(a) of this regulation shall be reduced by: (i) The face value of life insurance policies owned by the individual or the individual's spouse if the cash surrender value of those policies has been excluded from resources; and (ii) Amounts in an irrevocable burial fund as described under §G(7) of this regulation. (7) An irrevocable burial fund of any amount, which has been set aside for the burial of the individual or the individual's spouse. H. Exclusion of the home under §§F(1) and G(1) of this regulation and exclusion of income-producing property under §§F(1) and G(5) of this regulation do not prevent a lien being attached to or executed on the home or property except as provided in Regulation .15A-2(3) of this chapter. I. Treatment of Joint Accounts. (1) If a joint account exists between an applicant and a nonapplicant, all of the funds in the account are considered available to the applicant. (2) If a joint account exists between the spouse of an applicant and a nonapplicant, all of the funds in the account are considered available to the spouse of the applicant. (3) If a joint account exists between an applicant, the spouse of an applicant, and a nonapplicant, all of the funds in the account are considered available to the applicant and the spouse of the applicant. (4) Rebuttal of Presumption of Full Ownership Interest. (a) If the nonapplicant owner can demonstrate, to the Department's satisfaction, that the nonapplicant made regular and proportionate contributions of the nonapplicant's own funds to the account, a pro rata share of the funds is considered available to the nonapplicant. (b) If either the applicant, the spouse of the applicant, or the nonapplicant owner of a joint account believes that the ownership interest attributed to him or her by the Department under §I(1)—(3) or (4)(a) of this regulation is incorrect and can demonstrate, under §I(5)(b)of this regulation, to the satisfaction of the Department, an ownership interest other than that attributed to him or her by the Department, the Department shall consider the amount established through rebuttal as the correct amount for the purpose of determining eligibility for Medical Assistance. (5) Declaration of Ownership Interests. (a) The applicant and the nonapplicant of a joint account shall declare their ownership interests on a form designated by the Department. (b) The applicant shall provide adequate documentation to substantiate the declared ownership interests. (6) If the nonapplicant owner withdraws funds from the account during or after the 30-month period immediately before the month of application, the withdrawal is considered a disposal by the applicant or the spouse of the applicant to the extent that the remaining funds are less than the amounts considered available to the applicant under §I(1)—(4) of this regulation. J. Medicaid Qualifying Trust. (1) In the case of a Medicaid qualifying trust as defined under §B(12) of this regulation, the amount from the trust considered available to the person or the person's spouse establishing the trust is the maximum amount of payments that may be permitted under the terms of the trust to the beneficiary, assuming the full exercise of discretion by the trustee or trustees for the distribution of the maximum amount to the beneficiary. (2) Section J of this regulation shall apply whether or not the: (a) Medicaid qualifying trust is irrevocable or has been established for purposes other than to enable a person to qualify for Medical Assistance; or (b) Discretion described under §J of this regulation is actually exercised. (3) If the beneficiary of a trust is an intellectually disabled person who resides in an intermediate care facility for the intellectually disabled, the trust may not be considered a Medicaid qualifying trust if it was established before April 17, 1986 and is solely for the benefit of the intellectually disabled person. (4) The Department may waive the application of §J of this regulation if the Department determines that to do so would work an undue hardship. K. Disposal of Resources for Less than Fair Market Value. (1) In determining eligibility for Medical Assistance for any period under consideration beginning before October 1, 1993, an institutionalized individual shall be determined ineligible for nursing facility services, for a level of care in a medical institution equivalent to that of nursing facility services, and for waiver services under COMAR 10.09.27 and 10.09.31 if the individual or the individual's spouse: (a) Disposes of a resource for less than fair market value at any time during or after the 30-month period immediately before or after the date the person becomes an institutionalized person if the person is entitled to Medical Assistance on that date; or (b) If not entitled to Medical Assistance on that date, then on the date the person applies for Medical Assistance while an institutionalized person. (2) If a person disposes of a resource for less than fair market value while in a period of ineligibility for an earlier disposal, the later disposal is considered a part of the earlier disposal for purposes of computing the total period of ineligibility. (3) The period of ineligibility shall begin with the month in which the resource was transferred and the number of months in the period shall be equal to the lesser of: (a) 30 months; or (b) The total uncompensated value of the transferred resource, divided by the average cost, to a private patient at the time of application, of nursing facility services in the state in which the person is institutionalized. (4) An institutionalized person may not be determined ineligible for Medical Assistance under §K(1) of this regulation if the resource transferred was a home and title to the home was transferred to: (a) The spouse of the person; (b) The person's child as defined under Regulation .02B(12) of this chapter or who is blind or disabled as determined under Regulation .05D and E of this chapter; (c) A sibling of the person who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date the person became an institutionalized person; or (d) A son or daughter of the person other than the person's child described under §K(4)(b) of this regulation, who: (i) Is lawfully residing in the home, (ii) Was residing in the home for a period of at least 2 years immediately before the date the person became an institutionalized person, and (iii) Can establish, to the Department's satisfaction, that the son or daughter provided the care that permitted the person to reside at home rather than in an institution. (5) A person may not be determined ineligible for Medical Assistance by reason of the transfer of any resource, excluded or nonexcluded, if the resource was transferred under any one of the conditions below: (a) The resource was transferred to the community spouse, or to another for the sole benefit of the community spouse, as defined under Regulation .10-1B(1) of this chapter; (b) The resource was transferred to the person's son or daughter who is blind or disabled as defined under Regulation .05D and E of this chapter; (c) The resource was transferred to the person's spouse, or to another for the sole benefit of the person's spouse, if the spouse does not transfer the resource to another person for less than fair market value; (d) The person furnishes convincing evidence, consisting of testimony or other corroborative evidence, that the person intended to dispose of the resource at fair market value or for other valuable consideration; (e) The person furnishes convincing evidence that the resource was transferred exclusively for a purpose other than to qualify for Medical Assistance; or (f) The Department determines that the denial of eligibility would work an undue hardship. L. A unit shall be ineligible for any month in which countable resources exceed the applicable standard, but may reapply for any following month in which countable resources are less than or equal to the applicable standard. M. Schedule MA-2. N. Schedule MA-2A. #### Regulation .08-1 Disposal of Assets for Less Than Fair Market Value. *COMAR 10.09.24.08-1* A. Definitions. In this regulation, the following terms have the meanings indicated: (1) “Assets” means all income and resources of an individual and of an individual's spouse, including any income or resources which the individual or the individual's spouse is entitled to but does not receive because of action by: (a) The individual; (b) The individual's spouse; (c) A person, including a court or administrative body: (i) With legal authority to act in place of or on behalf of the individual or the individual's spouse, or (ii) Acting at the direction or upon the request of the individual or the individual's spouse. (2) “Trust” means a legal instrument, which is either revocable or irrevocable, created, other than by will, by a grantor for the benefit of designated beneficiaries under the laws of the State and subject to the management of a trustee or trustees who have a fiduciary responsibility to manage the trust's resources and income for the benefit of the beneficiaries. B. Disposal of Assets. (1) In determining eligibility for Medical Assistance for any period under consideration beginning on or after October 1, 1993, in the case of assets disposed of after August 10, 1993, a penalty period shall be established during which an individual is determined ineligible for nursing facility services, for a level of care in a medical institution equivalent to that of nursing facility services, and for home and community-based waiver services provided for under the authority of §1915(c) and (d) of the Social Security Act if the individual or the individual's spouse disposes of an asset for less than fair market value at any time during or after the time periods specified under §B(2) of this regulation. (2) Time Periods for Evaluating Disposals. (a) For assets other than trusts, the time period for evaluating disposals is the following: (i) For disposals earlier than February 6, 2006, the 36-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance. (ii) For disposals on or after February 6, 2006, the 60-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance. (b) In the case of payments from a trust or portions of a trust that are treated as a disposal of assets under Regulation .08-2B(4)(c), (5)(a)(ii), or (5)(b) of this chapter, the time period for evaluating disposals is the 60-month period immediately before the date as of which the individual both is an institutionalized individual and has applied for Medical Assistance. (3) The penalty period begins: (a) For a transfer before February 6, 2006, with the later of: (i) The first day of the month in which the asset was transferred; or (ii) The date on which the individual is eligible for Medical Assistance and, but for the transfer, would be receiving institutional level of care; and (b) For a transfer on or after February 6, 2006, with the later of: (i) The first day of the month in which the individual is eligible for Medicaid and would be receiving Medicaid nursing facility services but for the application of this penalty; or (ii) The month during or after which assets have been transferred for less than fair market value. (4) If the transfer occurs while the individual is in a penalty period for an earlier disposal, the penalty period begins on the first day of the first month following the end of the earlier penalty period. (5) The number of months in the penalty period are equal to the total, cumulative, uncompensated value of all assets transferred, divided by the average monthly cost, to a private patient at the time of application for Medical Assistance, of nursing facility services in the State. (6) Asset Transfers For Less Than Average Monthly Cost of Care. (a) If the amount of a transfer is less than the average monthly cost of nursing facility services in the State, the length of the penalty period is calculated based on the proportion of the average monthly cost of nursing facility services that was transferred. (b) If a series of transfers is made, each of which is less than the average monthly cost of nursing facility services, the penalty period is calculated based on the total, cumulative, uncompensated value of all assets transferred. (7) Transfers Not Equally Divisible. If the amount of a single transfer or the amount of the total, cumulative, uncompensated value of all assets transferred is not equally divisible by the average monthly cost of nursing facility services in the State, the length of the penalty period is calculated based on the proportion of the average monthly cost of nursing facility services that was transferred. (8) An institutionalized individual may not be determined ineligible for Medical Assistance under §B(1) of this regulation if the asset transferred was a home, and title to the home was transferred to: (a) The spouse of the individual; (b) The individual’s child as defined under Regulation .02B of this chapter or who is blind or disabled as determined under Regulation .05-4 of this chapter; (c) A sibling of the individual who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date the individual became an institutionalized individual; or (d) A son or daughter of the individual other than the individual’s child described under §B(8)(b) of this regulation, who: (i) Is lawfully residing in the home, (ii) Was residing in the home for a period of at least 2 years immediately before the date the individual became an institutionalized individual, and (iii) Can establish, to the Department's satisfaction, that the son or daughter provided the care that permitted the individual to reside at home rather than in an institution. (9) An individual may not be determined ineligible for Medical Assistance by reason of the transfer of any asset, excluded or countable, if the asset was transferred under one of the following conditions: (a) The asset was transferred to the individual's spouse or to another for the sole benefit of the individual's spouse; (b) The asset was transferred from the individual's spouse to another for the sole benefit of the individual's spouse; (c) The asset was transferred to, or to a trust established for the sole benefit of, the individual’s son or daughter who is blind or disabled as defined under Regulation .05-4 of this chapter; (d) The asset was transferred to a trust established for the sole benefit of a disabled individual, as defined under Regulation .05-4B of this chapter, younger than 65 years old; (e) The individual furnishes convincing evidence, consisting of testimony or other corroborative evidence, that the individual intended to dispose of the asset at fair market value or for other valuable consideration; (f) The individual furnishes convincing evidence that the asset was transferred exclusively for a purpose other than to qualify for Medical Assistance; or (g) The full value of the asset transferred by an individual for less than fair market value has been returned to the individual. (10) In the case of an asset held by an individual in common with another individual or individuals in a joint tenancy, tenancy in common, or similar arrangement, the asset, or the affected portion of the asset, shall be considered a transfer when any action is taken, either by the individual or by any other individual, that reduces or eliminates the individual's ownership or control of the asset. #### Regulation .08-2 Treatment of Trust Amounts. *COMAR 10.09.24.08-2* A. For the purpose of this regulation, “trust” has the meaning defined under Regulation .08-1A of this chapter. B. Treatment of Trusts Established after August 10, 1993. (1) In determining eligibility for Medical Assistance for any period under consideration beginning on or after October 1, 1993, in the case of trusts established after August 10, 1993, an individual shall be considered to have established a trust if assets of the individual as defined under Regulation .08-1A of this chapter were used to form all or part of the corpus of the trust and if any of the following persons established the trust other than by will: (a) The individual; (b) The individual's spouse; (c) A person, including a court or administrative body: (i) With legal authority to act in place of or on behalf of the individual or the individual's spouse, or (ii) Acting at the direction or upon the request of the individual or the individual's spouse. (2) In the case of a trust, the corpus of which includes assets of one of the individuals described under §B(1)(a) or (b) of this regulation and assets of any other individual or individuals, the provisions of this regulation apply to the portion of the trust attributable to the assets of the individual described under §B(1)(a) or (b) of this regulation. (3) The provisions of this regulation apply without regard to: (a) The purposes for which a trust is established; (b) Whether the trustees have or exercise any discretion under the trust; (c) Restrictions on when or whether distributions may be made from the trust; or (d) Restrictions on the use of distributions from the trust. (4) Revocable Trusts. In the case of a revocable trust: (a) The corpus of the trust shall be considered resources available to the individual; (b) Payments from the trust to, or for the benefit of, the individual shall be considered income of the individual; and (c) Other payments from the trust shall be considered assets disposed of by the individual. (5) Irrevocable Trust. In the case of an irrevocable trust, if there are any circumstances under which payment from the trust could be made to or for the benefit of the individual: (a) The portion of the corpus from which, or the income on the corpus from which, payment to the individual could be made shall be considered resources available to the individual, and payments from that portion of the corpus or income: (i) To or for the benefit of the individual, shall be considered income of the individual, and (ii) For any other purpose, shall be considered a transfer of assets; and (b) A portion of the trust from which, or any income on the corpus from which, a payment could not, under any circumstances, be made to the individual shall be considered to be assets disposed of by the individual, as of the date of establishment of the trust or, if later, the date on which payment to the individual was foreclosed. The value of the trust shall be determined, for purposes of evaluating the disposal, by including the amount of any payments made from that portion of the trust after the date of establishment or foreclosure. (6) The following trusts may not be counted in determining eligibility for Medical Assistance: (a) Special needs trusts as defined in §C of this regulation; and (b) A pooled special needs trust containing the assets of an individual who is disabled, and which meets all of the following conditions: (i) The trust is established and managed by a nonprofit association, (ii) A separate account is maintained for each beneficiary of the trust but, for purposes of investment and management of funds, the trust pools these accounts, (iii) Accounts in the trust are established solely for the benefit of disabled individuals by the parent, grandparent, or legal guardian of the individuals, by the individuals, or by a court, and (iv) To the extent that amounts remaining in the beneficiary's account upon the death of the beneficiary are not retained by the trust, the trust pays to the Department from the amounts remaining in the account an amount equal to the total amount of Medical Assistance paid on behalf of the beneficiary. (7) A nonprofit association that establishes and manages a trust consistent with the requirements of §B(6)(b) of this regulation may establish accounts for individuals for whom no governmental entity has made a determination of disability, provided that: (a) The beneficiary of the account has submitted, or is actively engaged in preparing to submit, an application to: (i) The Social Security Administration for Supplemental Security Income or Social Security Disability Insurance; or (ii) The Department of Human Services State Review Team for a disability determination using the Social Security Administration rules; and (b) The account is closed immediately upon a determination, exclusive of appeals, by any State or federal governmental agency that the beneficiary of the account is not disabled. C. Special Needs Trust. The following criteria shall define a single, stand-alone special needs trust that is funded with assets that belonged to the beneficiary: (1) The trust is irrevocable; (2) The trust states that the beneficiary is disabled under Regulation .05-4B of this chapter; (3) The beneficiary of the trust is younger than 65 years old at the time the trust is established and funded; (4) The trust has been established by: (a) The beneficiary; (b) The beneficiary’s parent; (c) The beneficiary’s grandparent; (d) The beneficiary’s legal guardian; or (e) A court; (5) The trust does not contain provisions that conflict with the policies set forth under this regulation; (6) The trust provides that all states which have provided medical assistance benefits to the beneficiary shall be paid their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states, up to the amount of assets remaining in the trust upon the death of the beneficiary; (7) If the trust allows for the termination of the trust before the death of the beneficiary, the trust shall provide that: (a) All states which have provided medical assistance benefits to the beneficiary shall be paid their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states, up to the amount of assets remaining in the trust at the time of termination, after administrative expenses related to the termination of the trust; (b) Other than amounts paid to the states under §C(7)(a) of this regulation and payment of administrative expenses and reasonable compensation to the trustee for trust management, along with reasonable costs associated with investment, legal, or other services, no entity other than the trust beneficiary may benefit from early termination of the trust; and (c) The power to terminate shall be held by someone other than the trust beneficiary; (8) The trust does not permit distribution of trust assets upon termination of the trust that would hinder or delay reimbursement to the states under §C(6) and (7) of this regulation; (9) The trust does not place time limits, or any other limits, on the states’ claim for reimbursement under §C(6) and (7) of this regulation; (10) The trust contains the following provisions: (a) Additions may not be made to the trust after the beneficiary is 65 years old; (b) Expenditures from the trust shall be used for the sole benefit of the beneficiary and shall be directly related to the beneficiary's health care, education, comfort, or support; (c) The trust beneficiary may not serve as trustee, cotrustee, trust protector, trust advisor, or in any other capacity that would allow the beneficiary to influence or exercise authority or control over distributions from the trust; (d) The trustee shall administer the trust in accordance with the provisions of Estates and Trusts Article, §15-502, Annotated Code of Maryland, and may not: (i) Except for the beneficiary’s relative, limited to the relatives defined at COMAR 10.09.24.02B(10)(a), who may have a contingent future interest in any trust funds remaining in the trust after the requirements of §C(6) of this regulation have been met, have an interest in trust assets; (ii) Have discretion to use trust assets for the trustee's own benefit; (iii) Self-deal by selling trust assets to the trustees or buying trust assets from the trustee; or (iv) Loan trust assets to the trustee; (e) Compensation to the trustee shall be limited in accordance with the provisions of Estates and Trusts Article, §14.5-708, Annotated Code of Maryland; (f) Any leases or mortgages that the trust may hold shall contain a provision that they either terminate or become due and payable upon the death of the beneficiary or termination of the trust; (g) If the trust owns titled property that is valued at more than $500, the property shall be titled in the name of the trust, except for securities, which may be held in the name of a nominee; (h) If the trust owns an asset jointly with another, the ownership shall be as tenants in common, and the ownership agreement shall provide that, upon termination of the trust, the property shall either be sold for fair market value or the other owners shall purchase the trust's interest in the property for fair market value; (i) Trust assets may not be held as an ongoing business or enterprise, or as investments in new or untried enterprises; (j) Trust distributions may not be used to supplement Medical Assistance payments to any health care provider delivering goods or services to the beneficiary; (k) Trust assets may not be used to purchase gifts; (l) Trust assets may not be used to purchase a life insurance policy on the life of the beneficiary; (m) Trust assets may only be used to purchase a life insurance policy on the life of someone other than the trust beneficiary if the trust is the only beneficiary of the life insurance policy; (n) Trust assets may not be used to purchase an annuity on the life of the beneficiary unless, upon the beneficiary’s death, all states which have provided medical assistance benefits to the beneficiary are paid, out of any remaining annuity payments, their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states. (o) The trust may not loan trust assets without security, which may include an interest in real or personal property of at least equivalent value; (p) The trust may only make loans if the loan agreement provides for immediate repayment in the event of the death of the beneficiary or termination of the trust for any other reason; (q) The only real property in which the trust may invest is in a single home property, which is used as the residence of the beneficiary and is titled in the name of the trust; (r) The trust may not disburse more than $100,000 for the purchase of property without the approval of the State circuit court in the jurisdiction in which the beneficiary resides; (s) An annual accounting of the trust, including a listing of current assets, income, and itemized distributions during the previous year, shall be sent to the Maryland Medical Assistance Program, Division of Recoveries and Financial Services; (t) Trust assets may not be used to pay funeral expenses of the beneficiary but may be used to purchase an irrevocable burial contract for the beneficiary to cover the beneficiary's funeral and burial expenses; (u) The trust may not receive payments from a structured settlement or an annuity that was purchased by funds that are not part of the trust unless: (i) Upon the beneficiary’s death, all states which have provided medical assistance benefits to the beneficiary are paid, out of any remaining annuity or settlement payments, their proportionate share of the total amount of medical assistance benefits paid on behalf of the beneficiary by all states; and (ii) The beneficiary’s right to receive payments from the annuity or structured settlement has been assigned irrevocably to the trust and such assignment was made before the trust beneficiary attains the age of 65; (11) A copy of the trust shall be sent to the Maryland Medical Assistance Program, Division of Recoveries and Financial Services, and if any amendments are made to the trust, the amendments shall comply with this section and a copy of the amendments shall be sent to the Division of Recoveries and Financial Services; (12) If the trust agreement fails to comply with any provision of this section, the full value of the assets of the trust shall be considered available resources of the trust beneficiary for Medical Assistance eligibility purposes. #### Regulation .08-3 Resource Consideration of Entrance Fees for Continuing Care Retirement Communities. *COMAR 10.09.24.08-3* A. Treatment of Entrance Fees before January 1, 2006. For Medical Assistance applications or requests for spousal resource assessments filed before January 1, 2006, the entrance fee shall be considered in accordance with the policies for exclusion of home property in this chapter. B. Treatment of Entrance Fees On or After January 1, 2006. (1) For Medical Assistance applications or requests for spousal resource assessments filed on or after January 1, 2006, an entrance fee shall be considered available to the owner as a countable resource if the CCRC provides written verification, based on CCRC practice or policy, which satisfies the Department that all of the following criteria are met: (a) The applicant or recipient or a designated beneficiary is eligible for a full refund of any amount remaining in the entrance fee, after subtracting any payments or transfers made by the individual in accordance with §B(1)(c)—(e) of this regulation, when the individual: (i) Dies; or (ii) Terminates the continuing care agreement and leaves the CCRC facility; (b) The entrance fee does not confer on the applicant or recipient a real property interest in the CCRC facility, in which case the entrance fee would be considered as excludable home property; (c) The applicant or recipient has the ability to obtain funds from the entrance fee, without moving from the CCRC facility, to pay the CCRC or another entity for support and maintenance if the individual's income and other resources are insufficient to pay for the support and maintenance; (d) If the Medical Assistance applicant or recipient has a son or daughter who is blind or disabled as defined under this chapter, the applicant or recipient has the ability to transfer unconditionally all or part of the entrance fee to the individual's blind or disabled son or daughter; and (e) If the Medical Assistance applicant or recipient is institutionalized and married to a community spouse the: (i) CCRC's entrance fee, if it is considered a countable resource in accordance with the requirements in §B of this regulation, shall be included in the assessment for the attribution of spousal resources, in accordance with Regulation .10-1 of this chapter; and (ii) CCRC shall permit the recipient to transfer unconditionally all or part of the entrance fee to the sole ownership of the community spouse according to the amount that is needed, after totaling other resources owned singly or jointly by the couple, for the community spouse resource allowance to total the protected amount calculated by the Department, in accordance with Regulation .10-1 of this chapter. (2) The Department shall grant the applicant or recipient the opportunity to rebut the CCRC's written verification that all of the conditions in §B of this regulation are met for consideration of the entrance fee as a countable resource. (3) If the applicant or recipient submits a rebuttal to the Department, the Department shall request additional documentation and evidence from the CCRC that support the basis for the CCRC's written verification of the availability of the entrance fee. (4) The entrance fee may not be considered as a countable resource for determining the applicant's or recipient's Medical Assistance eligibility if the: (a) Requirements in §B(1) of this regulation are not met; (b) CCRC imposes limitations, conditions, penalties, or otherwise restricts the individual's right to reside in the CCRC facility when the individual uses funds from the entrance fee to make payments or transfers in accordance with §B(1)(c) — (e) of this regulation; or (c) Applicant or recipient successfully rebuts, as determined by the Department in accordance with §B(2) of this regulation, the CCRC's written verification that all of the conditions in §B(1) of this regulation are met. #### Regulation .08-4 Resource Consideration of Long-Term Care Partnership Policies. *COMAR 10.09.24.08-4* A. This regulation establishes the rules for applicants and recipients who: (1) Own a long-term care (LTC) partnership policy; and (2) Meet all factors of Medicaid eligibility in accordance with MAGI Exempt coverage groups described in this chapter. B. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Defined Terms. (a) “Benefit payment amount” means the dollar value of LTC benefits which an insurance carrier has furnished on behalf of a partnership policyholder and which is disregarded from the resource amount when determining eligibility. (b) “Insurance carrier” means an insurer who issues an insurance policy and makes benefit payment amounts on behalf of a partnership policyholder. (c) “Partnership policy” means a LTC insurance policy that meets the requirements as described under COMAR 31.14.03.02 and whose benefit payment amount is disregarded from the resource amount when determining eligibility. (d) “Partnership policyholder” means an individual who owns a partnership policy under the federal LTC partnership program. (e) “Reciprocity compact” means an agreement among states having partnership programs that are approved under section 6021(b) of the Deficit Reduction Act of 2005, Public Law 109-171 (DRA). C. Partnership Policyholder Requirements. (1) An applicant or recipient shall meet all factors of Medicaid eligibility in accordance with rules for MAGI Exempt coverage groups set forth in this chapter. (2) An applicant or recipient shall have: (a) A Maryland partnership policy approved on or after January 1, 2009, that meets all certification requirements, as described in COMAR 31.14.03; or (b) A partnership policy approved in another state that has joined the national reciprocity compact under the federal LTC partnership program. (3) An applicant or recipient shall provide documentation of the partnership policy benefit payments that have been issued by an insurance carrier. (4) Subject to Regulation .10-2E of this chapter, an applicant or recipient who applies for LTC Medical Assistance in a nursing facility or through a waiver program shall be ineligible for payment for nursing facility services, or services under a home and community based waiver program, when the individual’s equity interest in home property exceeds the maximum allowable home equity amount as set forth in Regulation .10-2 of this chapter. D. Eligibility Determination for a Partnership Policyholder. (1) When determining the resources of an individual in accordance with Regulation .08 of this chapter, there shall be disregarded a dollar value equal to the benefit payment amount. (2) The benefit payment amount for purposes of the disregard set forth in §D(1) of this regulation shall: (a) For purposes of initial application, equal the dollar amount of benefits paid to or on behalf of the partnership beneficiary at the time of application; and (b) For purposes of redetermination, equal the benefit payment amount in §D(2)(a) of this regulation and the value of any additional benefits paid to or on behalf of the partnership beneficiary up to the time of redetermination, until all benefits under the partnership policy are exhausted. (3) At the time of application and at each redetermination, the Department shall request documentation of the benefit payment amount. E. With the exception of an amount equal in value to the benefit payment amount applied at the most recent redetermination period, partnership policyholders will continue to be subject to a penalty for asset transfers for less than fair market value in accordance with Regulation .08 of this chapter. F. Estate recovery by the Department is limited as set forth in Regulation .15A-3(5) of this chapter. #### Regulation .09 Determining Financial Eligibility for Noninstitutionalized Individuals. *COMAR 10.09.24.09* A. Basis. (1) Financial eligibility is determined on the basis of the countable net income and resources of members of the MAGI exempt assistance unit and those individuals whose income and resource are considered pursuant to Regulations .06, .07, and .08 of this chapter for the period under consideration. For current eligibility under spend-down, a review to identify changes in the unit's financial and nonfinancial eligibility status shall be made before spend-down eligibility is established. (2) The appropriate medically needy income level shall be the amount specified in Schedule MA-1 for the number of persons whose income is considered in determining financial eligibility. (3) The appropriate medically needy resource level shall be the amount specified in Schedule MA-2 for the number of persons whose resources are considered in determining financial eligibility. (4) Financial eligibility is determined on the basis of the countable income for members of the MAGI household unit and those individuals whose income are considered pursuant to Regulations .06-1 and .07 of this chapter for the period under consideration. For current eligibility under spend-down, a review to identify changes in the unit's financial and nonfinancial eligibility status shall be made before spend-down eligibility is established. B. Retroactive Eligibility. (1) When the countable net income and resources are equal to or less than the medically needy income and resource levels, eligibility exists as medically needy. (2) When the countable net income is greater than the medically needy income level and the countable resources are equal to or less than the medically needy resource level, retroactive eligibility may exist under the spend-down provision as specified in §B(4) of this regulation. (3) Excess Resources. Retroactive eligibility does not exist when the countable resources are greater than the medically needy resource level. (4) Retroactive Spend-Down Eligibility. (a) In determining retroactive spend-down eligibility, documented medical and remedial expenses incurred during the 3 months before the month of application of any person whose income and resources are considered in determining eligibility shall be considered if the incurred expenses: (i) Have not been paid for by any third party, including a family member or an insurer; and (ii) Are not required to be paid for by any third party, such as an insurer. (b) The incurred medical expenses shall be considered on a month-by-month basis beginning with the earliest month in the period under consideration and shall be deducted from excess income in the following order: (i) Medicare and other health insurance premiums, deductibles, or coinsurance charges; (ii) Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; (iii) Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. (c) Retroactive spend-down eligibility is established when the incurred medical expenses exceed the excess income. (d) The medical expense used to establish retroactive spend-down eligibility may not be: (i) Reimbursed by the Medical Assistance Program; or (ii) Used for any subsequent eligibility determination. (e) Retroactive spend-down eligibility is not established when the incurred medical expenses are equal to or less than the excess income. C. Current Eligibility. (1) When the countable net income and resources are equal to or less than the medically needy income and resource levels, eligibility exists as medically needy. (2) When the countable net income is greater than the medically needy income level and the countable resources are equal to or less than the medically needy resource level, eligibility may exist under the spend-down provision as specified in §C(4) of this regulation. Spend-down eligibility is established when the amount of the incurred medical expenses equals or exceeds the excess income. (3) Excess Resources. Eligibility does not exist when the countable resources are greater than the medically needy resource level. (4) Spend-Down Eligibility. (a) In determining spend-down eligibility, documented medical expenses incurred during the time periods and meeting the conditions specified in §C(4)(b)—(d) of this regulation shall be considered. (b) Medical expenses incurred before the month of application shall be considered if: (i) The expenses were not considered in any retroactive certification; (ii) The expenses were not used to establish spend-down eligibility for a prior certification; and (iii) The expenses are not paid for by any other person, remain the obligation of the person whose income and resources are considered in determining eligibility, and have not been forgiven by the provider of the services as evidenced by account statements dating up to 3 months before the month of application. (c) Medical expenses incurred at any time during or after the month of application and before the end of the period under consideration by any person whose income and resources are considered in determining eligibility shall be considered if the medical expenses: (i) Have not been paid for by any third party, including a family member or an insurer; and (ii) Are not required to be paid for by any third party, such as an insurer. (d) Each medical bill verifying expenses shall include a statement of the service and the date the service was rendered. For purchases of medicines and medical supplies or equipment, the statement from the provider shall include the item purchased and the date and cost of the purchase. (e) Medical expenses incurred during the time periods specified in §C(4)(b) and (c) of this regulation shall be deducted from the excess income beginning with the earliest time period and in the following order: (i) Medicare and other health insurance premiums, deductibles, or coinsurance charges; (ii) Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; (iii) Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. (f) Spend-down eligibility is established for the remainder of the period under consideration when the incurred medical expenses equal or exceed the amount of excess income. The medical expenses used to establish spend-down eligibility may not be: (i) Reimbursed by the Medical Assistance Program; or (ii) Used for any subsequent eligibility determination. (g) When spend-down eligibility is not established during the application process, the applicant shall be notified of his ineligibility and advised of the spend-down provision. The application date shall be preserved for possible spend-down eligibility at any time during the established period under consideration. (h) When the incurred medical expenses do not equal the amount of excess income during the period under consideration, eligibility does not exist. A new application date and period under consideration will be established when the applicant reapplies after the expiration of the established period under consideration. #### Regulation .10 Determining Financial Eligibility for Institutionalized Persons. *COMAR 10.09.24.10* A. Scope. (1) This section applies to persons who are institutionalized throughout a calendar month. (2) Institutional status is presumed to begin on the first day of the first full calendar month in which the person is institutionalized and ends on the last day of the last full calendar month before discharge. (3) Institutional status is not interrupted by a transfer from one long-term care facility to another or by a transfer from a long-term-care facility to a hospital. (4) Presumed institutional status changes on the first day of the month of discharge to the community. (5) Eligibility for noninstitutionalized persons shall be determined separately under Regulation .09 of this chapter. B. Basis. (1) Financial eligibility shall be determined on the basis of the countable resources and income of members of the assistance unit. (2) A person is categorically needy if his total income before deductions does not exceed 300 percent of the current SSI payment standard and his countable resources are within the applicable amount in Schedule MA-2A. (3) A person is medically needy if his total income before deductions exceeds 300 percent of the SSI payment standard or if countable resources exceed the applicable amount in Schedule MA-2A. (4) When calculating an institutionalized recipient's available income for the cost-of-care in a long-term care facility, in accordance with Regulations .10 and .10-1 of this chapter, guardianship fees may not be allowed as an income deduction, whether or not the recipient has a community spouse. C. Retroactive Eligibility. (1) A retroactive eligibility determination shall be made for services incurred by an institutionalized person within 3 months before the month of application. Eligibility will be considered only for the month, or months, in which the expenses were incurred. (2) The period under consideration shall be the month, or months, for which coverage is requested. (3) Excess Resources. When the countable resources are greater than the medically needy resource standard, retroactive eligibility does not exist. (4) Determination of Available Income for the Retroactive Period. The following amounts shall be deducted from the total income in the following order: (a) For dates of service beginning July 1, 2003, a personal needs allowance of: (i) $50 a month for an institutionalized person other than a person who meets the requirements of §C(4)(a)(iii) of this regulation. (ii) $100 a month for an institutionalized couple. (iii) $100 a month for a person who resided in an ICF/IID or mental hospital, participated in therapeutic work activities, and received remuneration for participation in these activities. An amount greater than $100 a month but not to exceed the MNIL may be deducted based on additional documented work-related need. (b) For dates of service beginning July 1, 2004, a personal needs allowance of: (i) $60 a month for an institutionalized person other than a person who meets the requirements of §C(4)(b)(iii) of this regulation; (ii) $120 a month for an institutionalized couple; and (iii) $100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and received remuneration for participation in these activities, and an amount greater than $100 a month but not to exceed the MNIL which may be deducted from available income based on additional documented work-related need. (c) For dates of service beginning July 1, 2005, a personal needs allowance adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living. (d) Spousal or Family Allowance or Both. For an institutionalized spouse as defined under Regulation .11B(6) of this chapter, an amount equal to the community spouse monthly income allowance as defined under Regulation .11B(2) of this chapter and, if applicable, an amount equal to the family allowance as determined under Regulation .11C(3)(c) of this chapter. For an institutionalized person without a spouse in the community, the amount needed to maintain an unmarried child or children younger than 21 years old living at home at a level which, based on verified need, equals the applicable medically needy income level. (e) Residential Maintenance Allowance for a Single Person. (i) For a person with no spouse or unmarried child younger than 21 years old at home, the amount not to exceed the medically needy income level that was needed to maintain the person's residence during the retroactive period shall be deducted beginning with the person's earliest first full month of institutionalization if, based on a medical review process established by the Department, it is determined that the person will be able to resume living in his community residence and that the person intends to do so. (ii) Institutional status is not interrupted by a transfer from one long-term care facility to another or by a transfer to a hospital. (f) Incurred expenses for medical care or remedial service that have not been paid for by any third party, including a family member or an insurer, and are not required to be paid for by any third party, such as an insurer, including: (i) Medicare and other health insurance premiums, deductibles or co-insurance charges; (ii) In the case of eligibility determinations before August 1, 2005, necessary medical care or remedial service recognized under State law but not covered under the State Plan; and (iii) In the case of eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, necessary medical care or remedial service recognized under State law but not subject to Medical Assistance reimbursement. (g) Incurred expenses for necessary medical care or remedial service described under §C(4)(f)(iii) of this regulation as follows: (i) For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, incurred expenses may not include medical expenses for dates of service more than 3 months before the month of the Medical Assistance application; and (ii) Incurred expenses shall be limited to the fees reimbursed by Medical Assistance in effect on the date of service and shall be for actual charges if no Medical Assistance fee exists. (h) The maximum deduction for unpaid nursing facility bills incurred during a penalty period resulting from a transfer of assets shall be zero. (5) Subject to the requirements of §C(6) of this regulation, effective October 1, 2016, the personal needs allowance set forth in §C(4) of this regulation shall be increased as follows: (a) For a Medicaid recipient who has been assigned a guardian of the person, $50 per month; (b) For a Medicaid recipient who has been assigned a guardian of the property, $50 per month; (c) For a Medicaid recipient who has been assigned a single guardian serving all purposes, $50 per month; and (d) For a Medicaid recipient who has been assigned one individual to serve as guardian of the person and one different individual to serve as guardian of the property, $100 per month. (6) A guardian shall submit a monthly bill to the Medicaid recipient or authorized representative in order for a guardianship fee to be added to the recipient’s personal needs allowance set forth in §C(4) of this regulation. (7) If the effective date cited in §C(4)(f)(ii) and (iii), and (g)(i) of this regulation is invalidated by final unappealable order of a court of competent jurisdiction, the effective date shall be April 1, 2009. (8) When the available income as determined under §C(4) of this regulation is equal to or less than the person's incurred cost-of-care to the facility and countable resources are equal to or less than the medically needy resource standard, retroactive eligibility exists and begins on the first day of the period under consideration. Certification is established under Regulation .11D of this chapter. (9) When the available income as determined under §C(4) of this regulation is greater than the person's incurred cost-of-care to the facility and countable resources are equal to or less than the medically needy resource standard, retroactive eligibility may exist under §C(10) of this regulation. (10) Retroactive Spend-Down Eligibility. (a) In determining retroactive spend-down eligibility, documented medical expenses incurred more than 3 months before the month of the Medical Assistance application shall be considered if the incurred expenses: (i) Have not been paid for by any third party, including a family member or an insurer; (ii) Are not required to be paid for by any third party, such as an insurer; (iii) Were not incurred during a penalty period; and (iv) Were not forgiven by the provider. (b) The incurred medical expenses shall be considered on a month-by-month basis beginning with the earliest month in the period under consideration and shall be deducted from excess available income in the following order: (i) Medicare and other health insurance premiums, deductibles, or co-insurance charges; (ii) Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; (iii) Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. (c) The medical expenses used to establish retroactive spend-down eligibility may not be: (i) Reimbursed by the Medical Assistance Program; (ii) Used for any subsequent eligibility determination; or (iii) Incurred before the period for which retroactive eligibility is requested. (d) Retroactive spend-down eligibility is established on the day the incurred medical expenses considered under §C(10)(b) of this regulation equal or exceed the excess available income. Certification is established under Regulation .11D of this chapter. (e) Retroactive spend-down eligibility is not established when the incurred medical expenses are less than the excess available income. D. Current Eligibility. (1) Excess Resources. When the countable resources are greater than the medically needy resource level, eligibility does not exist. (2) Determination of Available Income. The following amounts shall be deducted from total income in the following order: (a) For dates of service beginning July 1, 2003, a personal needs allowance of: (i) $50 a month for an institutionalized person other than a person who meets the requirements of §D(2)(a)(iii) of this regulation. (ii) $100 a month for an institutionalized couple. (iii) $100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and receives remuneration for participating in these activities. An amount greater than $100 a month but not to exceed the MNIL may be deducted based on additional documented work-related need. (b) For dates of service beginning July 1, 2004, a personal needs allowance of: (i) $60 a month for an institutionalized person other than a person who meets the requirements of §D(2)(b)(iii) of this regulation; (ii) $120 a month for an institutionalized couple; and (iii) $100 a month for a person who resides in an ICF/IID or mental hospital, participates in therapeutic work activities, and received remuneration for participation in these activities, and an amount greater than $100 a month but not to exceed the MNIL which may be deducted from available income based on additional documented work-related need. (c) For dates of service beginning July 1, 2005, a personal needs allowance adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living. (d) Spousal or Family Allowance or Both. For an institutionalized spouse as defined under Regulation .11B(6) of this chapter, an amount equal to the community spouse monthly income allowance as defined under Regulation .11B(2) of this chapter and, if applicable, an amount equal to the family allowance as determined under Regulation .11C(3)(c) of this chapter. For an institutionalized person without a spouse in the community, the amount needed to maintain an unmarried child or children younger than 21 years old living at home at a level which, based on verified need, equals the applicable medically needy income level. (e) Residential Maintenance Allowance for a Single Person. (i) For a person with no spouse or unmarried child younger than 21 years old at home, an amount not to exceed the medically needy income level needed to maintain the person's residence during institutionalization shall be deducted for a period of up to 6 months beginning with the person's first full month of current institutionalization if, based on a medical review process established by the Department, it is determined that the person will be able to resume living in his community residence during this period and that person intends to do so. (ii) The maximum 6-month period is not interrupted by a transfer from one long-term care facility to another or by admission to a hospital. (f) The following incurred medical expenses that are not subject to payment by a third party: (i) Medicare and other health insurance premiums, deductibles or co-insurance charges; (ii) For eligibility determinations before August 1, 2005, necessary medical care or remedial service recognized under State law but not covered under the State Plan; and (iii) For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, necessary medical care or remedial service recognized under State law but not subject to Medical Assistance reimbursement. (g) Incurred expenses for necessary medical care or remedial service described under §D(2)(f)(iii) of this regulation as follows: (i) For eligibility determinations on or after August 1, 2005, unless a court of competent jurisdiction issues a contrary ruling in a final unappealable order, incurred expenses may not include medical expenses for dates of service more than 3 months before the month of the Medical Assistance application; and (ii) Incurred expenses shall be limited to the fees reimbursed by Medical Assistance in effect on the date of service and shall be for actual charges if no Medical Assistance fee exists. (h) The maximum deduction for unpaid nursing facility bills incurred during a penalty period resulting from a transfer of assets shall be zero. (3) Subject to the requirements of §D(4) of this regulation, effective October 1, 2016, the personal needs allowance is increased as follows: (a) For a Medicaid recipient who has been assigned a guardian of the person, $50 per month; (b) For a Medicaid recipient who has been assigned a guardian of the property, $50 per month; (c) For a Medicaid recipient who has been assigned a single guardian serving all purposes, $50 per month; (d) For a Medicaid recipient who has been assigned one individual to serve as guardian of the person and one different individual to serve as guardian of the property, $100 per month. (4) A guardian shall submit a monthly bill to the Medicaid recipient or authorized representative in order for a guardianship fee to be added to the recipient’s personal needs allowance set forth in §D(2) of this regulation. (5) If the effective date cited in §D(2)(f)(ii) and (iii) and (g)(i) of this regulation is invalidated by final unappealable order of a court of competent jurisdiction, the effective date shall be April 1, 2009. (6) If, after application of the disregards in §D(2) of this regulation, the person's income equals or is less than the projected cost-of-care, eligibility exists and may begin on the first day of the period under consideration. The amount remaining after application of the disregards in §D(2) of this regulation is available income to be applied to the person's cost-of-care. Certification is established under Regulation .11D of this chapter. (7) If, after application of the disregards in §D(2) of this regulation, the person's income exceeds the projected cost-of-care, eligibility may be established under §D(8) of this regulation. (8) Spend-down Eligibility. (a) In determining spend-down eligibility, documented medical expenses incurred during the time periods and meeting the conditions specified in this section shall be considered. (b) Medical expenses incurred before the month of application shall be considered if the expenses: (i) Were not considered in any retroactive certification; (ii) Were not used to establish spend-down eligibility for a prior certification; (iii) Have not been paid for by any third party, including a family member or an insurer, and are not required to be paid for by any third party, such as an insurer; (iv) Were not incurred during a penalty period; (v) Remain the obligation of any person whose income and resources are considered in determining eligibility; and (vi) Have not been forgiven by the provider of the services, as evidenced by account statements dating up to 3 months before the month of application. (c) Medical expenses incurred at any time during or after the month of application and before the end of the period under consideration shall be considered if they: (i) Were not paid for by any third party, including a family member or an insurer; (ii) Are not required to be paid for by any third party, such as an insurer; (iii) Were not incurred during a penalty period; and (iv) Have not been forgiven by the provider. (d) Each medical bill verifying expenses shall include a statement of the service and the date the service was rendered. For purchases of medicines and medical supplies or equipment, the statement from the provider shall include the item purchased and the date and cost of the purchase. (e) Medical expenses incurred during the time periods specified in §D(8)(b) and (c) of this regulation shall be deducted from the excess available income beginning with the earliest time period and in the following order: (i) Medicare and other health insurance premiums, deductibles, or co-insurance charges; (ii) Expenses incurred for necessary medical care or remedial services that are recognized under State law but are not covered under the State Plan; (iii) Expenses incurred for necessary medical care or remedial services that are covered under the State Plan. (f) Spend-down eligibility is established for the remainder of the period under consideration on the day the incurred medical expenses, considered under §D(8)(e) of this regulation, including projected private cost-of-care obligations, equal or exceed the amount of excess available income. Certification is established under Regulation .11D of this chapter. (g) The medical expenses used to establish spend-down eligibility may not be: (i) Reimbursed by the Medical Assistance Program; or (ii) Used for any subsequent eligibility determination. (h) Eligibility exists on the day that incurred medical expenses equal or exceed the amount of excess available income. (i) When spend-down eligibility is not established during the application process, the applicant shall be notified of his ineligibility and advised of the spend-down provision. The application date shall be preserved for possible spend-down eligibility at any time during the established period under consideration. (j) Eligibility exists on the day during the preserved spend-down period that incurred medical expenses equal or exceed the amount of excess available income. Certification is established under Regulation .11D of this chapter. (k) When the incurred medical expenses do not equal the amount of excess available income during the period under consideration, eligibility does not exist. A new application date and period under consideration will be established when the applicant reapplies after the expiration of the established period under consideration. #### Regulation .10-1 Treatment of Income and Resources of Certain Institutionalized Spouses. *COMAR 10.09.24.10-1* A. Basis. (1) Except as this regulation specifically provides, the provisions of this regulation may not affect: (a) The determination of what constitutes income or resources; (b) The methodology and standards for determining and evaluating income and resources; (c) The criteria and standards for determining financial and nonfinancial eligibility for Medical Assistance; or (d) Any other provision of this chapter. (2) In determining the eligibility for Medical Assistance of an institutionalized spouse as defined under §B(6) of this regulation, the provisions of this regulation shall supersede any other provisions of this chapter which are inconsistent with them. (3) Sections D and E of this regulation, which concern the treatment of resources, shall apply to a person who begins a continuous period of institutionalization on or after September 30, 1989. Section C of this regulation, which concerns the treatment of income, shall apply to a person who begins a continuous period of institutionalization before or after September 30, 1989 and who remains institutionalized for a continuous period on or after September 30, 1989. Continuity is broken by absence from an institution for 30 consecutive days. B. Definitions. (1) “Community spouse” means a person who lives in the community outside an institution and who is married to an institutionalized spouse. (2) “Community spouse monthly income allowance” means the amount by which the minimum monthly maintenance needs allowance established under §C(5) of this regulation exceeds the amount of monthly income otherwise available to the community spouse. (3) “Community spouse resource amount” means the greatest of the amounts under §E(2)(a)—(d) of this regulation. (4) “Continuous period of institutionalization” means 30 consecutive days of institutional care in a medical institution or nursing home. (5) “Excess shelter allowance” means the amount by which the sum of the community spouse's expenses for shelter exceeds 30 percent of the amount described under §C(5)(a) of this regulation. Expenses for shelter include rent or mortgage payment, taxes and insurance for the community spouse's principal residence and the standard utility allowance used by the State under §5(e) of the Food Stamp Act of 1977. If the community spouse's principal residence is a condominium or cooperative, the required maintenance charge for the condominium or cooperative shall be included in the sum of the community spouse's expenses for shelter, and the standard utility allowance shall be reduced to the extent the required maintenance charge includes utility expenses. (6) “Family member” means minor or dependent children, dependent parents, or dependent siblings of the institutionalized or community spouse who are residing with the community spouse. (7) “Institutionalized spouse” means a person who is an inpatient in a nursing facility or who is an inpatient in a medical institution and with respect to whom payment is made based upon a level of care provided in a nursing facility, whose average length of stay exceeds 30 days and who is married to a person who is not in a medical institution or nursing facility. C. Treatment of Income. (1) Separate Treatment of Income. During any month in which an institutionalized spouse is in the institution, except as provided under §C(2) of this regulation, income of the community spouse may not be deemed available to the institutionalized spouse. (2) Attribution of Income. In determining the income of an institutionalized spouse or community spouse, after the institutionalized spouse has been determined to be eligible for Medical Assistance, the following apply: (a) Non-Trust Property. Except as provided under §C(2)(c) and (d) of this regulation, unless the instrument providing the income otherwise specifically provides, if payment of income is made: (i) Solely in the name of the institutionalized spouse or the community spouse, the income shall be considered available only to that respective spouse; (ii) In the name of the institutionalized spouse and the community spouse, 1/2 of the income shall be considered available to each of them; and (iii) In the names of the institutionalized spouse or the community spouse, or both, and to another person or persons, the income shall be considered available to each spouse in proportion to the spouse's interest or, if payment is made with respect to both spouses and no such interest is specified, 1/2 of the joint interest shall be considered available to each spouse. (b) Trust Property. In the case of a trust, income shall be considered available to each spouse as provided in the trust or, in the absence of a specific provision in the trust, if payment of income is made: (i) Solely to the institutionalized spouse or the community spouse, the income shall be considered available only to that respective spouse; (ii) To both the institutionalized spouse and the community spouse, 1/2 of the income shall be considered available to each of them; and (iii) To the institutionalized spouse or the community spouse, or both, and to another person or persons, the income shall be considered available to each spouse in proportion to the spouse's interest; or (iv) To both spouses and if the interest is not specified, 1/2 of the joint interest shall be considered available to each spouse. (c) In the case of income not from a trust in which there is an instrument establishing ownership, except as provided under §C(2)(d) of this regulation, 1/2 of the income shall be considered to be available to the institutionalized spouse and 1/2 to the community spouse. (d) Section C(2)(a) and (c) of this regulation shall be superseded to the extent that an institutionalized spouse can establish, by a preponderance of the evidence, that the ownership interests in income are other than as provided under these sections. (3) Protecting Income for the Community Spouse. After an institutionalized spouse is determined to be eligible for Medical Assistance, in determining the amount of the spouse's income that is to be applied monthly to payment for the cost of care in the institution, there shall be deducted from the spouse's monthly income the following amounts in the following order: (a) A personal needs allowance of: (i) $50 a month for dates of service beginning July 1, 2003; (ii) $60 a month for dates of service beginning July 1, 2004; and (iii) For dates of service beginning July 1, 2005, an amount adjusted annually by an amount not exceeding 5 percent to reflect the percentage by which social security benefits are increased by the federal government to reflect changes in the cost of living. (b) A community spouse monthly income allowance as defined under §B(2) of this regulation, but only to the extent income of the institutionalized spouse is made available to, or for the benefit of, the community spouse; (c) A family allowance, for each family member defined under §B(5) of this regulation, equal to 1/3 of the amount by which the amount described under §C(5)(a) of this regulation exceeds the amount of the monthly income of that family member; and (d) Incurred expenses for medical care or remedial service for the institutionalized spouse that are not subject to payment by a third party, including: (i) Medicare and other health insurance premiums, deductibles or co-insurance charges, and (ii) Necessary medical care or remedial service recognized under the State law but not covered under the State plan. (4) Incurred expenses for necessary medical care or remedial service described under §C(3)(d)(ii) of this regulation shall be limited to the fees reimbursed by Medical Assistance which are in effect on the date of service. (5) Establishment of Minimum Monthly Maintenance Needs Allowance. The minimum monthly maintenance needs allowance for a community spouse is the sum of: (a) The applicable percent, described under §C(6) of this regulation, of 1/12 of the income official poverty line for a family unit of two members; and (b) An excess shelter allowance as defined under §B(5) of this regulation. (6) Applicable Percent. For purposes of §C(5)(a) of this regulation, the applicable percent, effective as of the following dates, is: (a) September 30, 1989, 122 percent; (b) July 1, 1991, 133 percent; and (c) July 1, 1992, 150 percent. (7) Cap on Minimum Monthly Maintenance Needs Allowance. The minimum monthly maintenance needs allowance established under §C(5) of this regulation may not exceed $1,500, subject to adjustment under §G of this regulation, except as provided under §F(3) of this regulation. (8) Court Ordered Support. If a court has entered an order against an institutionalized spouse for monthly income for the support of the community spouse, the community spouse monthly income allowance as defined under §B(2) of this regulation shall be not less than the amount of the monthly income ordered. D. Treatment of Resources. (1) Computation of Spousal Share at the Time of Institutionalization. (a) Total Joint Resources. There shall be computed, as of the beginning of the first continuous period of institutionalization of the institutionalized spouse: (i) The total value of the resources to the extent either the institutionalized spouse or the community spouse has an ownership interest; (ii) A spousal share which is equal to 1/2 of the total value. (b) Assessment. At the request of an institutionalized spouse or community spouse, as of the beginning of the first continuous period of institutionalization of the institutionalized spouse and upon receipt of the relevant documentation of resources, the Department shall: (i) Promptly assess and document the total value of the resources; (ii) Provide a copy of the assessment and documentation to each spouse; and (iii) Retain a copy of the assessment for use under this regulation. (c) Request for Assessment When Not Part of the Medical Assistance Application. If the request is not part of an application for Medical Assistance, the Department may not include a notice indicating that the spouse has the right to a fair hearing as provided for under §F(1)(c) of this regulation, but shall require payment of a fee not to exceed the reasonable expense of providing and documenting the assessment. (2) Attribution of Resources at the Time of Initial Eligibility Determination. In determining the resources of an institutionalized spouse at the time of application for benefits under this chapter, regardless of any State laws relating to community property or the division of marital property, all the resources held by either the institutionalized spouse, the community spouse, or both, shall be considered to be available to the institutionalized spouse, but only to the extent that the amount of the resources exceeds the greatest of the amounts computed under §E(2)(a)—(d) of this regulation at the time of application for benefits. (3) Assignment of Support Rights. The institutionalized spouse may not be ineligible by reason of resources determined under §D(2) of this regulation when: (a) The resources are unavailable to the institutionalized spouse; (b) Payments are not being made for the care of the institutionalized spouse; (c) The institutionalized spouse, or that person's guardian or attorney in fact or representative, agrees to cooperate with the State in bringing a criminal action for nonsupport under Family Law Article, §§10-201 and 10-202, Annotated Code of Maryland; and (d) The institutionalized spouse, if capable of executing an assignment, has assigned all support rights from the community spouse to the State. (4) Resources may not be considered to be unavailable to the institutionalized spouse under §D3(a) of this regulation if the institutionalized spouse, or: (a) That spouse's guardian or attorney in fact has the legal authority to withdraw, liquidate, or otherwise access those resources; or (b) The institutionalized spouse's guardian or attorney in fact, has assisted in making those resources unavailable unless it can be demonstrated, to the Department's satisfaction, that the: (i) Action was primarily for a purpose unrelated to Medical Assistance eligibility, and (ii) Denial of eligibility would work an undue hardship. (5) Resources shall be considered to be unavailable to the institutionalized spouse under §D(3)(a) of this regulation only if the community spouse has willfully failed to, and refuses to, pay for care of the institutionalized spouse or cannot be located. (6) Section D(3)(c) or (d) of this regulation may not be considered to be satisfied if the institutionalized spouse, or the institutionalized spouse's guardian or attorney in fact, has taken any action or otherwise assisted in limiting his or her support rights from the community spouse. (7) The Department shall waive the requirements of §D(3)(c) or (d) of this regulation if the Department determines that denial of eligibility would work an undue hardship. (8) Separate Treatment of Resources After Eligibility for Benefits Established. During the continuous period in which an institutionalized spouse is in an institution and after the month in which an institutionalized spouse is determined to be eligible for benefits under this chapter, resources of the community spouse may not be deemed available to the institutionalized spouse. E. Permitting Transfer of Resources to the Community Spouse. (1) In General. An institutionalized spouse may, without regard to Regulation .08K of this chapter, transfer to the community spouse, or to another for the sole benefit of the community spouse, an amount equal to the community spouse resource allowance as defined under §E(2) of this regulation, but only to the extent the resources of the institutionalized spouse are transferred to, or for the sole benefit of, the community spouse. The transfer shall be made as soon as practicable after the date of the initial determination of eligibility, taking into account such time as may be necessary to obtain a court order under §E(3) of this regulation. (2) Community Spouse Resource Allowance Defined. The community spouse resource allowance is the amount by which the greatest of the following amounts exceeds the amount of resources otherwise available to the community spouse: (a) $12,000, subject to adjustment under §G of this regulation; (b) The lesser of the spousal share computed under §D(1)(ii) of this regulation or $60,000, subject to adjustment under §G of this regulation; (c) The amount established under §F(4) of this regulation; or (d) The amount transferred under a court order under §E(3) of this regulation. (3) Transfers Under Court Orders. If a court has entered an order against an institutionalized spouse for the support of the community spouse, Regulation .08K of this chapter may not apply to amounts of resources transferred under the order for the support of the spouse or a family member as defined under §B(5) of this regulation. F. Fair Hearing. (1) The spouse is entitled to a fair hearing as provided for under Regulation .14 of this chapter if either the institutionalized spouse or the community spouse is dissatisfied with the determination of any of the following: (a) Minimum monthly maintenance needs allowance as established under §C(5) of this regulation; (b) Determination of the amount of monthly income otherwise available to the community spouse; (c) Computation of the spousal share of resources under §D(1) of this regulation; (d) Attribution of resources under §D(2) of this regulation; or (e) Determination of the community spouse resource allowance as defined under §E(2) of this regulation. (2) Any hearing respecting the determination of the community spouse resource allowance shall be held within 30 days of the date of the request for the hearing if an application for benefits under this chapter has been made on behalf of the institutionalized spouse. (3) Revision of Minimum Monthly Maintenance Needs Allowance. If either the institutionalized spouse or the community spouse establishes that the community spouse needs income above the level provided by the minimum monthly maintenance needs allowance due to exceptional circumstances resulting in significant financial duress, the Department shall substitute, for the minimum monthly maintenance needs allowance established under §C(5) of this regulation, an amount adequate to provide the additional income as is necessary. (4) Revision of Community Spouse Resource Amount. If either the institutionalized spouse or the community spouse establishes that the community spouse resource amount, in relation to the amount of income generated by that amount, is inadequate to raise the community spouse's income, which shall include the amount of the community spouse monthly income allowance, to the minimum monthly maintenance needs allowance, the Department shall substitute, for the community spouse resource amount, an amount adequate to provide a minimum monthly maintenance needs allowance. G. For services furnished during a calendar year after 1989, the dollar amounts specified under §§C(7) and E(2)(a) and (b) of this regulation shall be increased by the same percentage as the percentage increase in the consumer price index for all urban consumers between September, 1988 and the September preceding the calendar year involved. #### Regulation .10-2 Substantial Home Equity and Exclusion of Long-Term Care Coverage. *COMAR 10.09.24.10-2* A. Subject to §E of this regulation, an institutionalized individual is not covered by Medical Assistance for long-term care services in a nursing facility, medical institution with a level of care equivalent to a nursing facility, or home and community-based services waiver if: (1) The individual’s equity interest in the individual’s home property, reduced by any bona fide, legally binding, documented encumbrances secured by the home, exceeds the amount specified in §D of this regulation; and (2) The individual does not have, lawfully residing in the home, the individual’s spouse or the individual’s son or daughter who is: (a) Younger than 21 years old; or (b) Blind or disabled as determined under Regulation .05-4 of this chapter. B. For all applications received on January 1, 2007 or after, the Department shall evaluate the institutionalized individual’s equity interest in the individual’s home property if the individual is determined eligible for Medical Assistance based on: (1) An initial determination of nursing facility or waiver eligibility; (2) A reapplication for nursing facility or waiver eligibility after a break in nursing facility or waiver eligibility; or (3) A redetermination after an initial determination or reapplication in accordance with §B(1) or (2) of this regulation. C. The institutionalized individual’s equity interest in the individual’s home property shall be evaluated by the Department, in accordance with §§A and B of this regulation, at: (1) The determination of nursing facility or waiver eligibility; and (2) Each subsequent redetermination of nursing facility or waiver eligibility. D. The maximum allowable equity interest specified at §A(1) of this regulation shall be $543,000 in calendar year 2014, adjusted annually as set forth in section 6014 of the Deficit Reduction Act of 2005, Pub. L. 109-171 (DRA) by the percentage increase in the consumer price index for all urban consumers, rounded to the nearest $1,000. E. Reductions to Equity Interest. (1) If the individual has ownership interest in no property other than the home, the benefit payment amount shall be applied to reduce an equal amount of home equity. (2) A mortgage, reverse mortgage, home equity loan, lien, or other bona fide encumbrance received by the individual and secured by the home property may be considered by the Department to reduce the individual’s equity interest in the home. F. An exclusion of long-term care coverage, in accordance with §A of this regulation, shall be applied even if there is a legal impediment to transferring or selling the home property. G. The Department may waive the application of §F of this regulation if the Department determines that denial of eligibility for long-term care coverage would work an undue hardship. #### Regulation .11 Certification Periods. *COMAR 10.09.24.11* A. This regulation specifies the time periods for certifying eligible members of an assistance unit. Certification periods for retroactive and current coverage will be based on consideration periods established in accordance with the provisions of Regulations .09 and .10 of this chapter. B. Certification of Eligible Noninstitutionalized Persons. (1) The following eligible noninstitutionalized persons shall be certified for a one-time-only period of 6 months or less and scheduled redetermination for continued eligibility may not be made: (a) Those who are certified for a retroactive period only, including retroactive spend-down; (b) Those who are certified under the spend-down provision; and (c) Those whose anticipated circumstances preclude eligibility beyond the current period. (2) Section B(1)(c) of this regulation is limited to: (a) A person who dies before the completion of the eligibility determination; (b) A migrant worker whose date of departure or expected date of departure from the State is known; and (c) A coverable inmate of a public institution who leaves the institution solely for admission to a medical facility. (3) Eligible persons not certified under §B(1) of this regulation shall be certified for a one-time-only period of 6 months and scheduled redetermination of eligibility shall be made. C. Date for Certification to Begin and End for Noninstitutionalized Persons. (1) Persons Eligible for Retroactive Coverage Under Spend-Down. (a) Certification begins on the day in the period under consideration on which retroactive spend-down eligibility was met. (b) Certification ends on the last day of the most recent month in the retroactive period in which coverable expenses were incurred. (c) Only persons who have coverable medical expenses during the period under consideration shall be certified. (d) Certification under this provision shall cover only those incurred medical bills that are not subject to third-party payment and remain the liability of persons in the assistance unit. (2) Persons Eligible for Retroactive Coverage Without Spend-Down. (a) Certification begins on the first day of the earliest month of the retroactive period under consideration in which coverable medical expenses were incurred. (b) Certification ends on the last day of the most recent month in the retroactive period in which coverable medical expenses were incurred. (c) Only persons who have coverable medical expenses during the period under consideration shall be certified. (d) Certification under this provision shall cover only those incurred medical bills that are not subject to third-party payment and remain the liability of persons in the assistance unit. (3) Persons Eligible for Current Coverage Under Spend-Down. (a) Certification begins on the day in the period under consideration on which medical expenses for services already received equal or exceed the amount of excess income. The beginning date of the certification period shall be established to exclude from coverage any full day after the application date and before the certification date for which all expenses for medical services were used to establish spend-down eligibility. (b) Certification ends on the last day of the period under consideration. (4) Individuals Eligible for the Maryland Medicaid Managed Care Program. (a) Initial certification shall be a period of 6 months. (b) Section C(4)(a) of this regulation applies only if the individual: (i) Has not been eligible for Medical Assistance any time during the calendar month immediately before the month of application; and (ii) Has no private health insurance. (c) An individual certified under §C(4)(a) of this regulation is not subject to the unscheduled redetermination requirements of Regulation .12C(2) of this chapter. (d) Subsequent certification periods shall be consistent with the provisions of this subsection. (5) All Other Persons. (a) Certification begins on the first day of the month of application. (b) Certification ends on the last day of the period under consideration. (6) Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of a deceased person may not continue beyond the date of death. (7) Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of an eligible new member of the assistance unit pursuant to Regulation .06D of this chapter may not precede the date he becomes a member of the household. D. Date for Certification to Begin and End for Eligible Institutionalized Persons. (1) Persons Eligible for Retroactive Coverage Under Regulation .10C(5) of this chapter. (a) Certification begins on the first day of the period under consideration. (b) Certification ends on the last day of the period under consideration. (2) Persons Eligible for Retroactive Coverage Under Regulation .10C(7) of this chapter. (a) Certification begins on the day the incurred medical expenses less health insurance and other third-party coverage equal or exceed the excess available income. (b) Certification ends on the last day of the period under consideration. (3) Persons Eligible for Current Coverage Under Regulation .10D(3) of this chapter. (a) Certification begins on the first day of the period under consideration or, at the option of the person or the person's representative, on the first day of the following month if coverage is not needed in the month of application. (b) Certification continues until the person is determined ineligible and scheduled redetermination of eligibility shall be made at least once every 12 months. (4) Persons Eligible for Current Coverage Under Regulation .10D(5) of this Chapter. (a) Certification begins on the day the incurred medical expenses less health insurance and other third-party coverage equal or exceed the excess available income. (b) Eligibility ends on the last day of the period under consideration or, if it is known that eligibility should terminate before the end of the period under consideration, on the appropriate earlier date, and scheduled redetermination of eligibility may not be made. (5) Notwithstanding the provisions of §D(1)—(4) of this regulation, certification of a deceased person may not continue beyond the date of death. #### Regulation .12 Post-Eligibility Requirements. *COMAR 10.09.24.12* A. Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following: (1) For eligible individuals in MAGI coverage groups: (a) The basis and effective date for eligibility; (b) Instructions for reporting changes that may affect the recipients eligibility; and (c) The right to request a hearing. (2) For eligible individuals in MAGI Exempt coverage groups: (a) A finding of eligibility, the beginning and ending dates for coverage; and (b) The right to request a hearing. (3) For ineligible individuals in MAGI coverage groups: (a) A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; (b) Information regarding application for MAGI exempt coverage groups; and (c) The right to request a hearing. (4) For ineligible individuals in MAGI exempt coverage groups: (a) A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; and (b) The right to request a hearing. B. Recipient Responsibility. (1) A recipient or his representative shall notify the Department or its designee within 10 working days of changes that may affect eligibility. (2) A recipient or his representative shall limit use of the Medical Assistance card to the person whose name appears on the card. (3) Third-Party Liability. (a) A recipient or his representative shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of any accident or other occurrence in which a third party might be liable. (b) Recipients shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information that would assist the Department or its designee in seeking reimbursement. (c) In accident situations, recipients shall notify the Department or its designee of the time, date, and location of the accident, the name and address of the attorney, the names and addresses of all parties and witnesses to the accident, and the police report number if an investigation is made. (4) When written notice of cancellation is received, a recipient shall discontinue use of the Medical Assistance card on the first day of ineligibility and return it to the Department or its designee. (5) Failure to comply with the provisions of §B(1), (2), and (3) of this regulation may result in the termination of assistance. (6) Failure to comply with the provisions of §B(1)—(4) of this regulation may result in legal action, referral to the Department or its designee for reimbursement, fraud investigation, or both, for illegal use of the Medical Assistance card. (7) Recipients shall cooperate with the Department’s quality control and audit review process, including provision and verification of all information pertinent to eligibility determination. Failure to cooperate may result in the termination of coverage. C. Redeterminations. (1) Redetermination for Former SSI Recipients. (a) The Department or its designee shall promptly redetermine eligibility when notice has been received from the Social Security Administration that an individual's SSI benefits have been terminated. (b) When notice of SSI termination is received, Department or its designee shall notify the person that redetermination is required to establish continuing eligibility and shall make the application available to him. (c) When the written or electronic, signed application is received by the Department or its designee, a new period under consideration will be set. The new period will be related to the date the application is received but may not include any months in which the individual was entitled to coverage under the current certification period. (d) The Department or its designee shall notify the individual or his representative of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. (e) All non-financial and financial factors for continuing eligibility shall be met. (f) The following applies when the individual is determined ineligible for Medical Assistance: (i) When the SSI termination is received by the tenth day of the month, the Department or its designee shall cancel certification effective the end of the month, unless the recipient requests a hearing in accordance with COMAR 10.01.04. (ii) When the SSI termination notice is received after the tenth day of the month, the Department or its designee shall cancel certification effective the end of the following month unless the recipient requests a hearing in accordance with COMAR 10.01.04. (g) The following applies when the person is determined ineligible for Medical Assistance: (i) When SSI termination is received by the tenth day of the month, the local department of social services shall cancel certification effective the end of the month, unless the recipient requests a hearing in accordance with Regulation .13 of this chapter. (ii) When the SSI termination notice is received after the tenth day of the month, the local department of social services shall cancel certification effective the end of the following month unless the recipient requests a hearing I accordance with Regulation .13 of this chapter. (h) Notice of Eligibility Decisions. (i) Eligible Individuals. Individuals who are determined eligible for a new period under consideration shall be sent notice in accordance with §A(1) and (2) of this regulation. (ii) Ineligible Individuals. Individuals determined ineligible shall be sent notice in accordance with §A(3) and (4) of this regulation. (i) When ineligibility is due to excess income only, the person will be provided with an explanation of the spend-down provision. Spend-down eligibility may be established at any time during the new period under consideration. (2) Unscheduled Redetermination. (a) The Department or its designee shall promptly make unscheduled redetermination when: (i) The person's circumstances suggest future changes which may affect eligibility before the due date of a scheduled redetermination; (ii) Relevant facts or changes in circumstances are reported by the recipient or someone on his behalf; or (iii) Relevant facts or changes are brought to the attention of the Department or its designee from other responsible sources. (b) The Department or its designee shall notify the recipient that redetermination is required to establish continuing eligibility. Notification will be sent in a timely manner so that a decision of eligibility will be made within 30 days from the date of change. (c) The Department or its designee shall notify the recipient of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. (d) The Department or its designee may not require the recipient or his representative to appear in unless the Department or its designee has determined that a face-to-face contact is necessary to make an accurate eligibility determination, or the recipient requests a face to face interview. (e) All non-financial and financial factors for continuing eligibility shall be met. (f) Eligibility Decisions. (i) Eligibility Continued for the Remainder of the Certification Period. Recipients who are determined eligible for the remainder of the certification period will be sent notice in accordance with §A(1) and (2) of this regulation. (ii) Recipients Determined Ineligible for the Remainder of the Certification Period. Recipients determined ineligible for the remainder of the certification period because of a change in circumstances or failure to establish eligibility following a change in circumstances, shall be sent notice in accordance with §A(3) and (4) of this regulation. (g) A person may reapply at any time after the cancellation of current eligibility and a new period under consideration will be established. (3) Scheduled Redetermination. (a) The Department or its designee shall make scheduled redeterminations at least once every 6 months for noninstitutionalized individuals certified under Regulation .11B(3) of this chapter and at least once every 12 months for institutionalized individuals certified under Regulation .11D(3) of this chapter. (b) The Department or its designee shall notify the recipient that redetermination is required to establish continuing eligibility. The notice and application will be sent at least 45 days before expiration of the current certification period. (c) When the written, telephonic, or electronic, signed application is received by the Department or its designee, a new period under consideration will be set. The new period will be related to the date the application is received but may not include any months in which the individual was entitled to coverage under the current certification period. (d) A recipient shall be treated the same as an applicant at the time of scheduled redetermination. (e) All nonfinancial and financial factors of eligibility shall be met. (f) The local Department or its designee shall make timely decisions in accordance with the provisions of Regulation .04H of this chapter. (g) Eligibility Decisions. (i) Eligibility Established. Applicants who are determined eligible for a new period under consideration shall be sent notice in accordance with §A(1) and (2) of this regulation. (ii) Ineligibility Established. Applicants determined ineligible for the new period under consideration shall be sent notice in accordance with §A(3) and (4) of this regulation. (h) When ineligibility is due to excess income only, the applicant will be provided with an explanation of the spend-down provision. Spend-down eligibility may be established at any time during the new period under consideration. D. Subsequent Application. A person may reapply when eligibility is not met during the periods established in §C(1) and (3) of this regulation. E. Continuous Eligibility for Children. (1) The Department shall establish continuous eligibility periods for individuals who are: (a) Younger than 19 years old; and (b) Eligible and enrolled for mandatory or optional coverage. (2) Individuals who are in a period of continuous eligibility shall, with the exception of the circumstances in §E(4) of this regulation, maintain coverage despite any change in circumstance that would otherwise preclude eligibility. (3) The period of continuous eligibility shall: (a) Begin on the first day of the month in which initial eligibility was determined or a renewal of eligibility is approved as a result of redetermination; and (b) Remain in effect for a 12-month period or for individuals covered under COMAR 10.09.62, until birth. (4) An individual’s eligibility may be redetermined during their continuous eligibility period if one or more of the following changes in circumstances occur: (a) The individual attains the maximum age specified in §E(1)(a) of this regulation; (b) The individual or the individual’s representative requests a voluntary termination of eligibility; (c) The individual ceases to meet the residency requirements established in Regulation .05-3 of this chapter; (d) The individual dies; or (e) The Department or its designee determines that eligibility was erroneously granted at the most recent determination, redetermination, or renewal of eligibility due to one or more of the following: (i) Agency error; or (ii) Fraud, abuse, or perjury attributed to the individual or the individual’s representative. #### Regulation .13 Hearings. *COMAR 10.09.24.13* The procedures for the Department or its designee granting a hearing to an applicant or a recipient and the status of benefits pending a hearing are set forth in COMAR 10.01.04. #### Regulation .14 Fraud. *COMAR 10.09.24.14* A. “Medicaid fraud” means: (1) Knowingly and willfully making or causing to be made any false statement or representation of a material fact in any application for any benefit or payment under a State plan established by Title XIX of the Social Security Act of 1939; (2) Knowingly and willfully making or causing to be made any false statement or representation of a material fact for use in determining rights to those benefits or payments; (3) Having knowledge of the occurrence of any event affecting: (a) The initial or continued right to those benefits or payments, or (b) The initial or continued right to those benefits or payments to any other individual in whose behalf an application has been made or in whose behalf benefits or payments are being received, and concealing or failing to disclose that event with an intent to secure fraudulently those benefits or payments either in a greater amount or quantity than is due or when benefits or payments are not authorized; (4) Having made application to receive or having received any of those benefits or payments for the use and benefit of another, and knowingly and willfully converting any part of the benefit or payment to a use other than for the use and benefit of that other person; (5) Fraudulently obtaining, attempting to obtain, or aiding another person in obtaining or attempting to obtain any drug product or any medical care, the benefit or payment of any part of which is or may be made from federal or state funds under a state Medical Assistance program, by use of: (a) Fraud, deceit, misrepresentation, or subterfuge; (b) Forgery or alteration of a Medical Assistance prescription; or (c) Concealment of any material fact or by the use of false names or addresses; (6) Possession of a blank Medical Assistance prescription, unless possession is authorized by: (a) A contract or other power, right, or permission to manufacture, store, transport, or distribute blank prescriptions; (b) A grant of a rendering privilege as evidenced by the issuance of a rendering number by a state Medical Assistance program by which one is authorized to prescribe pharmaceutical products for Medical Assistance recipients if the authorization: (i) To possess a blank Medical Assistance prescription terminates 30 days after notice of suspension or termination of provider status in a state Medical Assistance program or exhaustion of final appeal rights, whichever is later; and (ii) Does not extend to possession of blank Medical Assistance prescriptions which have been obtained from a source not authorized to distribute blank Medical Assistance prescriptions under §S(6)(a) of this regulation; or (c) Performance of one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program; (7) Possession of a Medical Assistance card without the authorization of the individual to whom the card is issued, unless: (a) Possession is obtained by a provider without knowledge that the presenting party lacked authorization; or (b) Possession is pursuant to one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program; (8) Manufacture, distribution, or possession of a counterfeit Medical Assistance card, or prescription blank except when possession is obtained: (a) By a provider without knowledge that the card or prescription blank is counterfeit; or (b) Pursuant to one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program; and (9) Manufacture, distribution, or possession of a provider identification plate used or capable of use to imprint Medical Assistance prescriptions unless authorized by: (a) A contract or other power, right, or permission to manufacture, transport, distribute, handle, or possess the plates; (b) Issuance by a state Medical Assistance program to the party in possession; or (c) Performance of one's lawful duties as a law enforcement officer or as one employed by a state Medical Assistance program. B. Examples. The following are examples of circumstances that may be Medicaid fraud: (1) Failure to report income, resources, if applicable, and family composition at the time of application or reapplication; (2) Failure to report within 10 working days any changes in income, resources, if applicable, and circumstances during any period of eligibility; (3) Lending a Medical Assistance card to another person; (4) Using or attempting to use a Medical Assistance card with intent to secure fraudulently benefits which are not authorized. C. LDSS Reporting. All cases of suspected Medicaid fraud that are discovered by personnel of a local department of social services shall be reported to the Department or its designee. D. Other Reporting. All cases of suspected Medicaid fraud that are discovered by agencies other than a local department of social services, that is, other state or federal agencies, providers, or concerned citizens, may be reported to the Department or its designee. E. Review and Investigation. The Department or its designee shall review and, when appropriate, investigate all referrals when an allegation is made that a misrepresentation of a material fact has been made or is suspected to have been made. F. Disposition of Referrals. Each referral shall be processed by the Department or its designee for appropriate resolution which includes, but is not limited to: (1) Referral for prosecution; (2) Filing of charges at District Court; (3) Recovery of incorrect benefit payments; (4) A finding that the allegation has not been sustained; (5) Referral to the appropriate agency; and (6) Other administrative action. G. Penalties. A person convicted of the crime of Medicaid fraud is subject to penalties as described in Criminal Law Article, §§8-510—8-512, Annotated Code of Maryland. #### Regulation .14-1 Recipient Abuse. *COMAR 10.09.24.14-1* A. Forms of Abuse. Recipient abuse exists when: (1) A recipient utilizes an inappropriate type of provider for care; (2) A recipient utilizes an appropriate type of provider at an inappropriate frequency for care; (3) A recipient utilizes an appropriate provider in an inappropriate manner; or (4) A recipient utilizes a Medical Assistance card in an inappropriate manner. B. Examples. The following are examples of circumstances that may be recipient abuse: (1) Misrepresenting to a provider material facts regarding symptoms, circumstances, or treatment by other providers; (2) Failing to affirmatively disclose to a provider any treatment or services being provided by another provider; (3) Losing or failing to maintain security sufficient to prevent loss or theft of more than one Medical Assistance card during a certification period; (4) Utilizing an emergency room of a hospital or a specialty outpatient clinic of a hospital as a primary care provider when primary care providers are available in the service area in which the recipient resides; (5) Underutilizing the appropriate providers for the proper care and management of an existing health condition; (6) Obtaining medications that require close physician monitoring while not appropriately using the physician services which could provide the monitoring; (7) Using or maintaining custody or possession of a Medical Assistance card in such a manner that it is used for an unauthorized or illegal purpose. C. Procedures. (1) The Department or its designee, shall determine whether recipient abuse exists using the procedures in §C(2)—(8) of this regulation. (2) Cases may be reviewed on the basis of statistical reports, outside complaints, referrals from other agencies, or other appropriate sources. (3) A preliminary review shall be conducted to determine whether the recipient's alleged or noted behavior is of the form specified under §A(1)—(3) of this regulation or is of the form specified under §A(4) of this regulation. (4) If the alleged or noted behavior is one of the types listed in §A(1)—(3) of this regulation, all relevant and available information shall be forwarded for medical review as specified under §B(5) of this regulation. (5) If the alleged or likely behavior is of the type listed in §A(4) of this regulation, all relevant and available information shall be forwarded for administrative review as specified under §C(7) of this regulation. (6) When a case is referred for medical review, a medical professional employed by the Department or its designee shall determine whether the recipient's use of medical services constitutes abuse, as defined under §A(1), (2), or (3) of this regulation. The medical reviewer shall consider all relevant and available information including Medical Assistance payment records and information secured from interviews, if conducted, in making a decision. The reviewer may, when appropriate, obtain records from other sources, including providers of medical services. (7) When a case is referred for administrative review, a determination shall be made by the Department or its designee, regarding whether the recipient's use of benefits constitutes abuse as defined under §A(4) of this regulation. (8) If a recipient has been convicted of a crime involving use of Medical Assistance benefits, as defined in §A of this regulation, the Department or its designee may consider the recipient to have committed abuse as described under §A(4) of this regulation. D. Notice. A recipient determined to have abused the Medical Assistance entitlement shall receive notice to that effect. Notice includes the following: (1) A statement of the reason or reasons why the recipient was found to have abused the Medical Assistance entitlement; (2) If applicable, a statement that the recipient will be enrolled in the Corrective Managed Care Program and the effective date and duration of that enrollment; (3) A statement regarding an opportunity to provide additional information which will be considered before enrollment becomes effective; (4) If applicable, a statement regarding an opportunity to identify a preference for an assigned primary medical care provider or pharmacy; and (5) A statement of appeal rights under Regulation .13 of this chapter. E. Consideration of Recipient Information. (1) Additional information received from the recipient under §D(3) of this regulation is considered relative to the appropriateness of the recipient's enrollment in the Corrective Managed Care Program. (2) Notice of the determination of the Department or its designee regarding the additional information shall be sent to the recipient. The notice shall either confirm or reverse the decision to enroll the recipient. (3) Information received from the recipient under §D(4) of this regulation is considered relative to the designation of a primary medical provider or pharmacy in accordance with §G(7) of this regulation. F. Corrective Managed Care Program. (1) A recipient determined to have abused the Medical Assistance entitlement shall be enrolled in the Corrective Managed Care Program in which the recipient shall be required to meet the requirements of §F(1)—(3) of this regulation. (2) The recipient shall obtain all covered physician, hospital outpatient and inpatient, and clinic services, except methadone clinic and all other drug and alcohol abuse services and emergency services, from, or upon written referral by, a single primary medical provider. (3) The recipient shall obtain prescribed drugs only from a single designated pharmacy provider, except in an emergency or pursuant to hospital inpatient treatment. G. Provider Selection. (1) The Department or its designee shall select primary medical and pharmacy providers for the recipient according to the requirements of §G(2)—(7) of this regulation. (2) The primary medical provider may be any physician who participates in the Medical Assistance Program and whose practice is chiefly in one of the following specialties which include general practice, family practice, pediatrics, obstetrics-gynecology, or internal medicine. (3) The Department or its designee may also designate a physician group, community health center, or clinic which participates in the Program as a physician provider and which assigns practitioners in one or more of the specialties named under §G(2) of this regulation to be the designated primary medical provider for the recipient. (4) The Department or its designee may designate a provider which delivers limited or specialty services if the designation is in the recipient's best interest and the provider agrees to deliver or manage the recipient's primary care and refer the recipient for other services as necessary. (5) The pharmacy provider may be any pharmacy, or any single branch of a pharmacy chain, which participates in the Medical Assistance Program. (6) The recipient shall be afforded an opportunity to suggest primary medical and pharmacy providers. However, the Department or its designee is not bound by the recipient's suggestion and may designate other providers if, in its sole discretion, the recipient's choice of provider would not serve the recipient's best interest in achieving appropriate use of the health care system and of Medical Assistance benefits. H. The Program may designate a new primary medical or pharmacy provider if the: (1) Recipient moves out of the service area of the provider; (2) Provider originally selected refuses to serve as the recipient's provider; (3) Program determines that the provider is not reasonably accessible to the recipient or does not meet accepted standards of medical or pharmacy practice; (4) Recipient has not responded affirmatively to the imposition of restrictions; or (5) Recipient's best interest in achieving appropriate use of the health care system and of Medical Assistance benefits would, in the Program's sole discretion, be better served by an alternative designation. I. Time of Period of Enrollment for the Corrective Managed Care Program. (1) The period of enrollment is 24 months. (2) A recipient who has completed the period of enrollment and who is subsequently found, through the procedures specified under §C of this regulation, to have resumed abusive practices, shall be enrolled for an additional period of 36 months. (3) A recipient found to have abused Medical Assistance benefits while enrolled in the Corrective Managed Care Program shall have the enrollment period extended for 24 months. (4) A recipient who has been found on three separate determinations under §C(5)—(7) of this regulation to have abused Medical Assistance benefits shall be enrolled for a period of 60 months. J. If an enrolled recipient loses and regains eligibility for Medical Assistance benefits, the recipient shall be re-enrolled at the resumption of eligibility for a full enrollment period. K. The final determination of abuse, the decision to enroll the recipient for the Corrective Managed Care Program, and the designation of primary medical and pharmacy providers shall be the responsibility of the Department or its designee. L. The recipient shall be given notice of an opportunity for a hearing in conformity with COMAR 10.01.04. #### Regulation .15 Liens, Adjustments, and Recoveries. *COMAR 10.09.24.15* A. Definitions. In this regulation, the following terms have the meanings indicated: (1) “Dependent” means a: (a) Child of the decedent, or the decedent's descendants; (b) Sibling, including half or step, of the decedent; or (c) Parent of the decedent, or the decedent's ancestors. (2) “Discharge from a long-term care facility and return home” means the release of a person from that facility for the purpose of returning to the home for permanent residence. (3) “Equity interest in the home” means co-ownership of the home which is not the result of a transfer of the property for less than the fair market value within 2 years before institutionalization. (4) “Estate” means all real and personal property and other assets included within an individual's estate, as defined for purposes of State probate law. (5) “Group health plan” means any plan, including a self-insured plan, of or contributed to by an employer to provide health care, directly or otherwise, to the employer's employees, former employees, or their families. (6) “Incorrect payment of benefits” means payment of benefits to which a recipient is not entitled. (7) “Lawfully residing in the home” means residing in the home with the permission of the owner or, if under guardianship, the owner's legal guardian. (8) “Real property” means property which is fixed or immovable, such as land or a building. (9) “Residing in the home on a continuous basis” means using the home as the principal place of residence. (10) “Substantial hardship” means the Department's estate claim will result in the sale or transfer of the real property owned by the decedent and that the sale or transfer will result in the removal from the property of a dependent who: (a) Resided in the property on the date of the decedent's death; (b) Has resided in the property continuously for a period beginning at least 2 years before the decedent's death; and (c) Cannot provide an alternate residence. A-1. The Department shall make a claim against income or resources, or both, of a recipient for benefits correctly paid, or to be paid, under the following circumstances: (1) Under a court order; (2) In any situation in which a recipient has a cause of action against any person for medical expenses arising from that cause of action; or (3) As a result of payment by the Department for services for which health care coverage was available to a recipient. A-2. Liens. (1) Incorrect Payments. Following a court judgment which has determined that benefits were incorrectly paid for a person, the Department shall impose a lien against the person's property, both personal and real, before the person's death, on account of Medical Assistance claims paid or to be paid on the person's behalf. (2) Correct Payments. Except as provided under §A-2(3) of this regulation, the Department shall impose a lien against the real property of a person, before the person's death, on account of Medical Assistance claims paid or to be paid on that person's behalf under the following circumstances: (a) The person owns real property, is a patient in a long-term care facility, and is required, as a condition of receiving Medical Assistance services, to spend for costs of medical care all but a minimal amount of his income required for personal needs; and (b) The Department has determined, after notice and opportunity for a hearing, that there is no reasonable expectation that the person can be discharged from the long-term care facility and return home. (3) Restrictions on Placing a Lien. The Department may not impose a lien on the home of an institutionalized individual under §A-2(2) of this regulation if any of the following individuals lawfully reside in the home. The institutionalized individual's: (a) Spouse; (b) Child as defined in Regulation .02B of this chapter; (c) Son or daughter who is blind or disabled as defined in Regulation .05D and E of this chapter; or (d) Sibling, who has an equity interest in the home and who was residing in the home for a period of at least 1 year immediately before the date of the institutionalized person's admission to a long-term care facility. (4) Termination of a Lien. Any lien imposed on a person's real property under §A-2(2) of this regulation will dissolve if the person is discharged from a long-term care facility and returns to the home. (5) Delay in the Imposition of a Lien. (a) When the imposition of a lien against a person's property is delayed because of the person's mental incompetence, eligibility may be granted pending the appointment of a legal representative for the person. (b) The effective date of the lien shall be the date eligibility was granted. A-3. Adjustments and Recoveries. (1) The Department shall seek recovery of Medical Assistance benefits correctly paid: (a) From the estate of any individual who was 55 years old or older when the individual received Medical Assistance benefits; and (b) From the estate or upon sale of the property on which a lien was imposed and which was owned by an individual described under §A-2(2) of this regulation. (2) The Department shall seek recovery under §A-3(1) of this regulation of Medical Assistance benefits correctly paid only: (a) After the death of the person's surviving spouse; (b) When the individual has no surviving child as defined in Regulation .02B of this chapter; (c) When the person has no surviving son or daughter who is blind or disabled as defined in Regulation .05D and E of this chapter; and (d) In the case of liens imposed on a person's home under §A-2(2) of this regulation, when there is no: (i) Sibling of the person lawfully residing in the home, who has resided there for a period of at least 1 year immediately before the date of the person's admission to a long-term care facility and who has lawfully resided there on a continuous basis since that time, or (ii) Son or daughter of the person lawfully residing in the home, who has resided there for a period of at least 2 years immediately before the date of the person's admission to a long-term care facility, who has lawfully resided there on a continuous basis since that time, and who can establish to the Department's satisfaction that he or she provided the care that permitted the person to reside in the home rather than in the facility. (3) The Department may not seek recovery from the estate of a deceased individual under §A-3(1) and (2) of this regulation if, in the Department's judgment, substantial hardship exists. (4) The Department may not seek recovery from the estate of a deceased individual for Medical Assistance payments of Medicare premiums, copayments, or deductibles. (5) The Department may not seek recovery from the estate of a deceased individual to the extent of the value of LTC partnership policy benefits furnished to the individual up to the time of death. B. The Department shall accept reimbursement when voluntarily offered by a current or former recipient or someone acting on his behalf. C. Repealed. D. Extended Benefits Pending a Hearing Decision. (1) The Department or its designee shall consider reimbursement in all cases in which: (a) A recipient received extended benefits pending a hearing and decision by an administrative law judge at the Office of Administration Hearings; and (b) The administrative law judge affirmed the original decision of the Department or its designee. (2) The Department or its designee shall institute procedures to recover the cost of any expenditures made on behalf of a recipient in cases identified in §D(1) of this regulation. This provision may not apply to a individual who requested a hearing and extended benefits resulting from a bona fide belief that the Department or its designee has taken an adverse action erroneously. E. The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or person acting responsibly for the recipient. F. Assignment of Benefits, Release of Information, and Requirement of Cooperation by Recipient in Recovery Procedures. (1) A recipient of Medical Assistance is deemed to have created an authorization for the release to the Department of all data, records, and information by insurance companies, nonprofit health service plans, providers of medical care, employers, unions, governmental agencies, and any other agencies, organizations, or individuals necessary for the Department's pursuit of third-party reimbursement. The authorization extends to all information relevant to third-party reimbursement or third-party health care coverage. (2) The local department of social services shall take reasonable measures to identify and report to the Department on a form designated by the Department all possible third-party benefits available to persons determined eligible for Medical Assistance. (3) The Department shall collect available benefits from third parties determined liable to pay for services received under Medical Assistance. (4) An individual who receives medical services that was or will be paid for by Medical Assistance is deemed to have made assignment to the Department of: (a) His own rights to any medical care support available under an order of a court or an administrative agency, and any third-party payments for medical care; and (b) The rights of any other individual eligible under the plan, for whom he can legally make an assignment. (5) Assignment of rights to benefits does not include assignment of rights to Medicare benefits. (6) An applicant or recipient of Medical Assistance shall cooperate in: (a) Establishing paternity for a child born out of wedlock for whom he can legally assign rights; and (b) Obtaining medical care support and payments for himself and any other individual for whom he can legally assign rights. (7) Waiver. (a) The Department shall waive the requirements in §G(6) of this regulation if the Department, through the local department of social services, determines that the individual has good cause for refusing to cooperate. (b) With respect to establishing support paternity of a child born out of wedlock or obtaining medical care and payments for a child for whom the individual can legally assign rights, the Department, through the local department of social services, shall find that cooperation is against the best interests of the child if it is reasonably anticipated that cooperation will result in: (i) Physical harm to the child for whom support is to be sought; (ii) Emotional harm to the child for whom support is to be sought; (iii) Physical harm to the parent or caretaker relative with whom the child is living which reduces the person's capacity to care for the child adequately; or (iv) Emotional harm to the parent or caretaker relative with whom the child is living, of such nature or degree that it reduces the person's capacity to care for the child adequately. (c) If at least one of the following circumstances exists, and the Department, through the local department of social services, believes that because of the existence of that circumstance, in the particular case, proceeding to establish paternity or secure support would be detrimental to the child for whom support would be sought, the Department, through the local department of social services, shall find that cooperation is against the best interests of the child: (i) The child for whom support is sought was conceived as a result of incest or forcible rape; (ii) Legal proceedings for the adoption of the child are pending before a court of competent jurisdiction; or (iii) The applicant or recipient is currently being assisted by a public or licensed private social agency to resolve the issue of whether to keep the child or relinquish him for adoption, and the discussions have not gone on for more than 3 months. (d) If the Department of Human Services has made a finding that good cause for refusal to cooperate does or does not exist, the Department shall adopt that finding as its own for this purpose. (e) With respect to obtaining medical care support and payments for an individual in any case not covered by §G(7)(b) or (c) of this regulation, the Department, through the local department of social services, shall find that cooperation is against the best interests of the individual or other person to whom Medical Assistance is being furnished, if it is reasonably anticipated that cooperation will result in reprisal against, and cause physical or emotional harm to, the individual or other person. (8) The Department or its designee shall: (a) Deny or terminate eligibility for any applicant or recipient who refuses to cooperate as required under §G(6) of this regulation unless cooperation has been waived; (b) Provide Medical Assistance to any individual who: (i) Cannot legally assign his own rights, and (ii) Would otherwise be legally eligible for Medical Assistance but for the refusal by a person legally able to assign his rights or to cooperate as required by this regulation. (9) The assignment created by this regulation shall be effective as long as the recipient is eligible for Medical Assistance and remains effective for all services paid by the Program during this period of eligibility, and for those services which were erroneously provided to ineligible persons and paid for by the Program. #### Regulation .16 Interpretive Regulation. *COMAR 10.09.24.16* Except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. #### Regulation .17 Information from and Liability of Health Insurance Carriers. *COMAR 10.09.24.17* A. A carrier shall: (1) Provide, at the request of the Department, information about individuals who are eligible for benefits under the Program or are Program recipients so that the Department may determine: (a) Whether an individual, the spouse of an individual, or the dependent of an individual is receiving health care coverage from a carrier; and (b) The nature of that coverage; (2) Provide the information required under §A of this regulation in a manner prescribed by the Department; and (3) Accept the Program's right of recovery and the assignment to the Program of any right of an individual or other entity to payment from the carrier for an item or service for which payment has been made under the Program if the carrier has a legal obligation to make payment for the item or service. B. Subject to §A of this regulation, a carrier may not reject, deny, limit, cancel, refuse to renew, increase the rates of, affect the terms or conditions of, or otherwise affect a health insurance policy or contract for a reason based wholly or partly on the: (1) Eligibility of the individual for receiving benefits under the Program; or (2) Receipt by an individual of benefits under the Program. C. A carrier shall comply with the provisions of Health-General Article, §15-144, Annotated Code of Maryland, pertaining to health maintenance organizations. ### Chapter 25 — Transportation Services Under the Individuals with Disabilities Education Act (IDEA) **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective February 12, 1997 (24:5 Md. R. 391); adopted permanently effective May 19, 1997 (24:10 Md. R. 710) **Administrative History:** Regulation .01B amended effective December 18, 2006 (33:25 Md. R. 1951) #### Regulation .01 Definitions. *COMAR 10.09.25.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Child's family” means those individuals with whom a participant resides, who are responsible for the participant, and who are the primary nurturing caregivers. (2) “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. (3) “Early intervention services (EIS)” means services which are consistent with COMAR 13A.13.01.02. (4) “Individualized education program (IEP)” means a written description of special education and related services developed by a multidisciplinary team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.09. (5) “Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.02. (6) “Individuals with Disabilities Education Act (IDEA)” means the federal statute which provides for a free appropriate public education (FAPE) for children with disabilities from ages 3 to 21 and early intervention services for infants and toddlers with developmental delay, from birth to age 3. (7) “Infants and toddlers with disabilities” means children from birth through 2 years old who are eligible for early intervention services, as documented by appropriate qualified personnel as defined in COMAR 13A.13.01.02. (8) “Local education agency (LEA)” means a local public school district. (9) “Local lead agency (LLA)” means the agency designated by the local governing authority in each county and Baltimore City to administer the interagency system of early intervention services under the direction of the Office for Children. (10) “Maryland State Department of Education (MSDE)” means the Department established by Education Article, Title 2, Annotated Code of Maryland. (11) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (12) “Multidisciplinary” means the involvement of two or more disciplines or professions in the provision of integrated and coordinated services, including evaluation and assessment activities and the development of the individualized family service plan or individualized education program. (13) “Multidisciplinary team” means a group convened and conducted by the provider to develop the participant's IEP, which is composed of the child's parent or parents, the child's teacher, and relevant service providers as indicated in COMAR 13A.05.01.08A. (14) “Office for Children” means the Office for Children established under Executive Order 01.01.2006.03. (15) “Parent” means a biological or adoptive parent, a legal guardian, another individual responsible for a child's welfare, or a surrogate parent for those cases when: (a) A public agency, after reasonable efforts, cannot discover the whereabouts of a biological or adoptive parent; (b) An individual cannot be identified with responsibility for a child's welfare; or (c) The child is a ward of the State. (16) “Participant” means a Medical Assistance recipient who is eligible for Medical Assistance reimbursement for transportation services under IDEA. (17) “Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (18) “Provider” means a local education agency, local lead agency, State-operated education agency, or State-supported education agency which meets the conditions for participation stated in Regulation .03 of this chapter, to provide transportation services under IDEA. (19) “State-operated education agency” means a State agency that operates education programs for children with disabilities in accordance with COMAR 13A.05.01. (20) “State-supported education agency” means an entity accredited by the Maryland State Board of Education to operate a school in accordance with COMAR 13A.09.10. (21) “Transportation” means transportation services provided pursuant to COMAR 13A.06.07. #### Regulation .02 Licensure and Certification. *COMAR 10.09.25.02* A. Providers shall meet the requirements of COMAR 13A.06.07. B. Providers shall meet all the requirements of the jurisdiction in which they operate. #### Regulation .03 Conditions for Participation. *COMAR 10.09.25.03* Providers shall meet all requirements for participation in the Program stated in COMAR 10.09.36.03 and COMAR 13A.06.07. #### Regulation .04 Covered Services. *COMAR 10.09.25.04* A. The Program covers the services listed in §B of this regulation when the services are provided to a child: (1) Eligible for services under IDEA; (2) Who is an eligible Medicaid recipient; (3) Who was transported to or from a Medicaid-covered service under IDEA; (4) Whose transportation and Medicaid-covered service or services are included on the child's IEP or IFSP. B. The following services are covered under this chapter: (1) Transportation to or from a school where a Medicaid-covered IDEA service is provided; (2) Transportation to or from a site where a Medicaid Early Intervention-covered IDEA service is provided; and (3) Transportation between a school and a Medicaid-covered IDEA service. #### Regulation .05 Limitations. *COMAR 10.09.25.05* A. To participate in the Program as a provider of transportation services under IDEA, a provider shall be a local education agency, a local lead agency, a State-operated education agency, or State-supported education agency. B. Providers shall only bill the Program for transportation services on dates when other Medicaid covered services are provided. #### Regulation .06 Payment Procedures. *COMAR 10.09.25.06* A. Request for Payment. (1) An enrolled provider shall submit a request for payment of services rendered and completed under this chapter according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all payment requests not properly prepared or submitted. (2) The provider shall submit a request for payment in the manner specified by the Department. The completed form shall indicate the: (a) Date or dates of service; (b) Participant's name and Medical Assistance number; (c) Provider's name, location, and provider number; and (d) Nature, unit or units, and procedure code or codes of covered services provided. B. The Program may not make direct payment to the participant. C. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. D. Reimbursement for transportation services shall be $12.50 per one way trip, of which the State portion is certified by the Maryland State Department of Education. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.25.07* Recovery and reimbursement is as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.25.08* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.25.09* Appeal procedures are those set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.25.10* Interpretive regulations are those set forth in COMAR 10.09.36.10. ### Chapter 26 — Community Based Services for Developmentally Disabled Individuals Pursuant to a 1915(c) Waiver **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective February 13, 1984 (11:5 Md. R. 455); emergency status extended at 11:7 Md. R. 621; adopted permanently effective August 12, 1984 (11:15 Md. R. 1330) **Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029) **Administrative History:** Chapter revised effective February 20, 1989 (16:3 Md. R. 343) **Administrative History:** Chapter revised as an emergency provision effective April 1, 1990 (17:8 Md. R. 969); amended permanently effective July 30, 1990 (17:14 Md. R. 1758) **Administrative History:** Regulations .03A, .09B, .11B amended as an emergency provision effective November 19, 1990 (17:24 Md. R. 2835); emergency status extended at 18:4 Md. R. 444 (February 22, 1991); amended permanently effective February 18, 1991 (18:3 Md. R. 305) **Administrative History:** Chapter revised as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 6, 1991 (18:13 Md. R. 1482) **Administrative History:** Regulations .01—.03, .05—.11, and .13 amended and .08-1—.08-4 adopted as an emergency provision effective June 8, 1992 (19:12 Md. R. 1130); emergency status extended at 19:19 Md. R. 1702; adopted permanently effective September 28, 1992 (19:19 Md. R. 1707) **Administrative History:** Regulations .01, .04—.08-3, .09—.11, and .13 amended effective February 28, 1994 (21:4 Md. R. 277) **Administrative History:** Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .01B amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulations .02, .06, .08-2, .09, and .13 amended as an emergency provision effective November 4, 1992 (19:24 Md. R. 2124); amended permanently effective February 15, 1993 (20:3 Md. R. 258) **Administrative History:** Regulation .02 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .03E adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .05J amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .08-5 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .09 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .10A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .11B amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .12 repealed and new Regulation .12 adopted effective February 17, 2003 (30:3 Md. R. 179) **Administrative History:** Regulation .13C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1480); emergency status extended at 36:2 Md. R. 96; emergency status extended at 36:17 Md. R. 1310; amended permanently effective October 19, 2009 (36:21 Md. R. 1591) #### Regulation .01 Definitions. *COMAR 10.09.26.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Alternative living unit” means a residence that: (a) Provides residential services for individuals who, because of developmental disabilities, require specialized living arrangements; (b) Admits not more than 3 individuals; and (c) Provides 10 or more hours of supervision per unit per week. (2) “Appropriate evaluation” means the assessment of an individual by qualified developmental disabilities professionals using accepted professional standards to document the presence of a: (a) Developmental disability as defined in Health-General Article, §7-101(e), Annotated Code of Maryland; or (b) Severe, chronic disability that qualifies the individual for support services as defined in Health-General Article, §7-403(c), Annotated Code of Maryland. (3) “Chronic care facility” means an institution which: (a) Falls within the jurisdiction of Health-General Article, §19-307(a)(1)(ii), Annotated Code of Maryland; and (b) Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. (4) “Day habilitation services” means a program of habilitation and health-related services which is routinely provided during the day in a community setting for a minimum of 30 hours per week, not less than 5 days per week, according to an individually designed and implemented plan of services. On one of the 5 days the program may be provided for not less than 4 hours. The habilitation program may include scheduled training or skills development activities which are conducted at sites away from the day habilitation services center. (5) “Day habilitation services center” means a facility or a site which provides day habilitation services to individuals with developmental disabilities who do not require 24-hour inpatient care, but who, due to the degree of disability, are not capable of full-time independent living. (6) “Department” has the meaning Maryland Department of Health as stated in COMAR 10.09.36. (7) “Developmental Disabilities Administration (DDA)” means that agency of the Maryland Department of Health which, under Health-General Article, Title 7, is charged with the responsibility for providing services to persons who are developmentally or otherwise disabled. (8) “Developmental disability” means a severe chronic disability of an individual that: (a) Is attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; (b) Is manifested before the individual attains the age of 22; (c) Is likely to continue indefinitely; (d) Results in an inability to live independently without external support or continuing and regular assistance; and (e) Reflects the need for a combination and sequence of special interdisciplinary or generic care, treatment, or other services that are individually planned and coordinated for the individual. (9) “Environmental modifications” means physical adaptation to a community residence, when documented in the Individualized Service Plan as being necessary to make the residence accessible and to meet the needs of the waiver participant being served in that setting. (10) “Group home” means a residence that: (a) Provides residential services for individuals who, because of developmental disability, require specialized living arrangements; (b) Admits at least 4 but not more than 8 individuals; and (c) Provides 10 or more hours of supervision per home, per week. (11) “Habilitation services” means a program which assists an individual to acquire and maintain those life skills that enable the individual to cope more effectively with the demands of the individual's own person and environment, and to raise the level of the individual's physical, mental, social, and vocational functioning including, but not limited to, programs of treatment with training in self-help, daily living, and survival skills. (12) Home. (a) “Home” means a house or apartment: (i) Which is rented or owned by the waiver participant or the waiver participant's family or proponent; (ii) Which may be held in trust for the waiver participant, or the waiver participant may be a roommate without appearing on a lease or title; and (iii) Where the waiver participant lives with not more than two other unrelated waiver participants. (b) “Home” does not mean a house or apartment that is owned or rented by a provider, although the provider may be a guarantor of rental or mortgage payments. (13) “Home and Community Based Services Waiver for the Developmentally Disabled” means the document and any amendments to it submitted by the single State agency for Title XIX and approved by the Secretary of Health and Human Services which authorize the waiver of statutory requirements limiting coverage for home and community based services under the Medical Assistance Program's State Plan. (14) “Individual family care home (IFC)” means a private, single family residence licensed by the Department which: (a) Under supervision, provides a home for individuals with developmental disabilities in a family atmosphere; and (b) Provides habilitation services for one to three individuals who are not related to the caregiver. (15) “Individual Habilitation Plan (IHP)” means the written plan of specific action as specified in COMAR 10.22.05, which is developed and modified by an appropriately constituted interdisciplinary team. (16) “Individualized Service Plan (ISP)” means the document serving as the basis for effective and efficient services coordination for the client, developed by an interdisciplinary team with the input and approval of the client, or the client's representative, as appropriate, focusing upon the broad service areas needed by the client, and recorded and managed by the client's service coordinator. (17) “Intensive behavior management” means a specialized program designed to serve waiver participants who have been identified as having emotional disturbance or maladaptive behavior of sufficient severity to prevent or jeopardize community living. (18) “Interdisciplinary team” means a group convened by the waiver participant's service coordinator, which meets to design effective, efficient individualized plans and programs, with membership comprised of, but not limited to, the waiver participant, the waiver participant's family or representative, the waiver participant's service coordinator, representatives of providers, individuals with various professional skills which are relevant to the needs of the waiver participant, and other human services staff. (19) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36. (20) “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, because of their degree of impairment, need health maintenance and restorative services supportive to their community living. (21) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (22) “Nursing facility” means a facility or a distinct part of a facility which is participating in the Medical Assistance Program as a nursing facility provider under COMAR 10.09.10 or 10.09.11. (23) “Physician” means an individual licensed to practice medicine in the state in which services are provided. (24) “Plan of care” means the written, individualized plan of care developed for a waiver participant in accordance with the requirements under COMAR 10.09.48, 10.22.09, or 10.22.11. (25) “Program” has the meaning stated in COMAR 10.09.36. (26) “Provider” means an agency which is licensed or certified to furnish covered services under these regulations through an appropriate agreement with the Department. (27) “Provider agreement” means the contract between the Department and the provider specifying the services to be performed, methods of operation, financial and legal requirements which shall be in force before Program participation is allowed. (28) “Qualified developmental disabilities professional (QDPP)” means an individual who: (a) Is a registered nurse, physician, or an individual with a bachelor's degree in a relevant discipline which may include, but not be limited to: (i) Occupational therapy, (ii) Physical therapy, (iii) Psychology, (iv) Social work, (v) Recreation, (vi) Education; and (b) Has a minimum of 1 year full-time or equivalent experience working directly with persons with an intellectual disability or other developmental disability. (29) “Recipient” has the meaning stated in COMAR 10.09.36. (30) “Residential habilitation services” means that training provided in a group home, alternative living unit, or individual family care home to a waiver participant which promotes skills necessary for maximum independence in daily activities of living. (31) “Residential option services” means one or more of the services described in Regulation .08-2 of this chapter which are intended to assist eligible waiver participants, regardless of the nature and severity of their disability, to live independently and successfully in the community by assisting them to perform activities of daily living and enabling them to live in homes of their choice, receive services from providers of their choice, and take into account the use of community resources and natural supports. (32) “Respite care” means a service for waiver participants designed to provide time-limited and temporary relief for primary informal caregivers from the ongoing responsibility of providing care for waiver participants, as well as to provide a back-up service system in the event of a crisis or emergency involving a primary informal caregiver. (33) “Room and board” means rent or mortgage, utilities, and food. (34) “Service coordinator” means a case management professional who is a qualified developmental disabilities professional (QDDP) selected by the client and employed by a service coordination provider under this chapter to assist the client in gaining more efficient and effective access to the service delivery system. (35) “Services coordination” means a service that consists of the following 3 major functions that are designed to assist an individual in obtaining the needed services and programs that the individual desires in order to gain as much control over the individual's own life as possible: (a) Planning services; (b) Coordinating services; and (c) Monitoring service delivery to the individual. (36) “State residential center” means a place that: (a) Is owned and operated by this State; (b) Provides residential services for individuals with an intellectual disability and who, because of an intellectual disability, require specialized living arrangements; and (c) Admits 9 or more individuals with a diagnosis of an intellectual disability. (37) “Supported employment” means paid work in a variety of regular work settings in which persons without disabilities are employed, and which are especially designed for individuals with developmental disabilities facing severe impediments to employment due to the nature and complexity of their disabilities, irrespective of age or vocational potential. (38) “Waiver participant” means a recipient who meets the eligibility requirements of these regulations. #### Regulation .02 Licensing Requirements. *COMAR 10.09.26.02* A. Providers of residential habilitation services shall be licensed pursuant to COMAR 10.22.03 or 10.22.14. B. Providers of day habilitation or supported employment services shall be licensed pursuant to COMAR 10.22.12 or 10.22.13. C. Providers of services coordination services shall be licensed by the Department pursuant to COMAR 10.22.09. D. Providers of residential option services shall be licensed pursuant to COMAR 10.22.11.04. E. Providers of intensive behavior management shall be: (1) Licensed by the Department to provide services for developmentally disabled individuals; or (2) Approved by the DDA as qualified to render services in accordance with COMAR 10.22.10. F. Providers of any service covered under this chapter, with the exception of medical day care services, may be issued a deemed status license by the Director of DDA, in accordance with the deemed status provisions in Health-General Article, §7-903(b), Annotated Code of Maryland. G. Providers of medical day care services shall be licensed pursuant to COMAR 10.12.04. H. DDA shall comply with all applicable provisions of COMAR 10.21 when: (1) Enrolling providers for services covered under this chapter; (2) Authorizing a provider to serve greater numbers of waiver participants; or (3) Transferring authorized positions for waiver participants from one provider to another provider. #### Regulation .03 Conditions for Participation. *COMAR 10.09.26.03* A. General requirements for participation in the Medical Assistance Program are that the providers: (1) Meet all conditions for participation specified in COMAR 10.09.36, except as otherwise specified in this regulation; (2) Meet the licensure requirements as provided in Regulation .02 of this chapter; (3) Have a provider agreement in effect with the Developmental Disabilities Administration and the Medical Assistance Program; (4) Verify the licenses of all service agencies with whom they contract and have a copy of the same available for inspection; (5) Verify the licenses and credentials of all professionals whom they employ or with whom they contract and have a copy of same available for inspection; (6) Maintain a written clinical record for each waiver participant which includes: (a) A copy of the waiver participant's signed statement indicating the alternatives of care locations offered to him or her, and his or her choice; (b) Date of: (i) Discharge from a State residential center or a nursing or chronic care facility into the services covered under this chapter; or (ii) Diversion from a State residential center or chronic care facility into the services covered under this chapter; and (7) Have waiver participants reevaluated annually by the interdisciplinary team. B. Services coordination providers shall submit individualized service plans to the DDA or its designee. C. Environmental Modifications. (1) Residential habilitation or residential option services providers shall provide environmental modifications as necessary to meet the needs of waiver participants after receiving prior authorization from DDA. (2) Environmental modifications shall be: (a) Provided by the residential habilitation or residential option services provider in getting a residence ready to be occupied; and (b) Performed in accordance with applicable codes of the locality. D. Respite Care. (1) Residential habilitation or residential option services providers shall provide respite care as necessary to meet the needs of waiver participants. (2) Respite care services shall be received in a: (a) State residential center; or (b) Community residence: (i) Operated by a provider of residential habilitation services; and (ii) Licensed by the State, in accordance with COMAR 10.22.03.02A(9)(b) and (c), to provide respite care. E. Medical day care providers: (1) Shall meet the requirements of COMAR 10.09.07; and (2) Are exempt from meeting the requirements of Regulation .18D of this chapter. #### Regulation .04 Covered Services for Services Coordination. *COMAR 10.09.26.04* The Department shall reimburse for services coordination which shall include the following: A. Convening the interdisciplinary team and conducting the team meeting for the development and revision of the ISP; B. Assisting the waiver participant in identifying, negotiating, and obtaining needed services that are agreed upon and specified in the ISP; C. Arranging, coordinating, and monitoring the delivery of services specified in the ISP; D. Reassessing or arranging for the periodic reassessment of the waiver participant's needs and services; E. Participating in the development of the waiver participant's initial IHP; F. Participating in reviews of the waiver participant's IHP; and G. Assisting the waiver participant in maximizing the use of the following sources of services and equipment in an effort to achieve the least costly, yet appropriate, delivery of services to the waiver participant: (1) Services provided at no cost by governmental or charitable agencies, such as the Department of Social Services or the Department of Vocational Rehabilitation, (2) Services covered by the Program or other third-party payors, (3) Generic services covered by other programs, (4) Services that can be paid for with the waiver participant's funds. #### Regulation .05 Covered Services for Residential Habilitation. *COMAR 10.09.26.05* A. The Department shall reimburse residential habilitation services providers for those services listed below, exclusive of room and board. These regulations do not limit payments, within the fiscal guidelines of the Department, for room, board, and normal living expenses for waiver participants. B. Habilitation. The services shall be provided as required and recommended in the IHP. Residential habilitation services providers shall provide, as a minimum, the following: (1) A program of habilitation which shall: (a) Be specified in the IHP, (b) Provide training in the development of self-help, daily living, self-advocacy, and survival skills, and (c) Use the principles of the Developmental Model; (2) Mobility training to maximize use of public transportation in traveling to and from work training or day programs, work sites, community services, and recreational sites; (3) Training and assistance in developing appropriate social behaviors which are normative in the surrounding community such as conducting one's self appropriately in restaurants, on public transportation vehicles, in recreational facilities, and in stores and other public places; (4) Training and assistance in developing patterns of living, activities, and routines which are appropriate to the waiver participant's age and the practices of the surrounding community and which are consistent with the waiver participant's interest and capabilities; (5) Training and assistance in developing basic safety skills; (6) Training and assistance in developing competency in housekeeping skills including, but not limited to, meal preparation, laundry, and shopping; (7) Training and assistance in developing competency in personal care skills such as bathing, toileting, dressing, and grooming; (8) Training and assistance in developing health care skills, including but not limited to, maintaining proper dental hygiene, carrying out the recommendations of the dentist or physician, appropriate use of medications, application of basic first aid, arranging medical and dental appointments, and summoning emergency assistance; (9) Training and assistance to waiver participants in developing money management skills which include recognition of currency, making change, bill paying, check writing, record keeping, budgeting, and saving; (10) Supervision of individuals as appropriate. C. Medical. Medical services provided shall be under the direction of a physician and shall include the following: (1) Evaluation, diagnosis, and treatment; (2) Consultation with the waiver participant and his or her family, staff members, and personal physician, if any; (3) Participation in the development of the initial IHP; (4) Monitoring, reevaluation and follow-up of medical services as appropriate; (5) Referral of waiver participants who require additional medical treatment and services which are not available at the residential services site. D. Occupational Therapy. Occupational therapy services shall be provided that are required and recommended in the IHP and shall include: (1) Specifications of the treatment to be rendered, the frequency and duration of that treatment, and the expected results; (2) Evaluation and reevaluation of the waiver participant's level of functioning through the use of standardized or professionally accepted diagnostic methods; (3) Development and delivery of appropriate treatment programs which are designed to significantly improve a waiver participant's level of functioning within a reasonable period of time; (4) Selection and teaching of task-oriented therapeutic activities designed to restore physical functioning; (5) Improvement of mobility skills. E. Psychiatric. Psychiatric services shall be provided as recommended in the IHP, under the direction of a board certified psychiatrist, and shall include: (1) Treatment and prevention of behavioral or emotional disorders which result from psychiatric or neurological conditions; (2) Written assessment of the waiver participant's mental and emotional status; (3) Consultation with the waiver participant's personal physician, and other individuals involved in the care of the waiver participant as appropriate; (4) Periodic monitoring and follow-up of waiver participant's progress. F. Psychological. Psychological services shall be provided as required and recommended in the IHP and shall include: (1) A written evaluation that includes use of psychometric data, provided that there is a significant change in the waiver participant's level of functioning, or behavior, or both; (2) Interviews and consultations with the waiver participant, family, and other pertinent individuals; (3) Participation in the development of the initial IHP, monitoring, reevaluation, and follow-up of specific individual programs as appropriate; (4) Assessment and treatment related to the emotional needs of the waiver participant; (5) Consultation with staff; (6) Development and implementation of behavior modification programs. G. Physical Therapy. (1) Physical therapy services shall be provided as required and recommended in the IHP which specify: (a) Part or parts of the body to be treated; (b) Type of modalities or treatments to be rendered; (c) Expected results of physical therapy treatments; (d) Frequency and duration of treatment. (2) The needs assessment shall indicate services which are of a diagnostic, habilitative, therapeutic, or maintenance nature to prevent further deterioration. (3) Services shall meet accepted standards of medical practice, with developed time frames for effective professional treatment. H. Social. Social services shall be provided as required and recommended in the IHP and shall include: (1) Identification of the waiver participant's social needs; (2) Individual counseling to assist the waiver participant's adaption to the environment; (3) Family and group counseling to assist and facilitate the waiver participant's adjustment. I. Speech Pathology and Audiology. Speech pathology and audiology services shall be provided as required and recommended in the IHP and shall include: (1) Maximization of communication skills; (2) Screening, evaluation, counseling, treatment, habilitation, or rehabilitation of waiver participants with hearing, language, or speech handicaps; (3) Coordination of interdisciplinary goals related to hearing and speech needs; (4) Consultation with staff regarding the waiver participant's programs. J. Nursing. Nursing services shall be provided which: (1) Are preauthorized by DDA as being medically necessary and not otherwise covered by the Program; (2) Are rendered under the direction of a physician; (3) Are required and recommended in the waiver participant's ISP; and (4) May include: (a) Meeting with provider's staff to discuss how the medical services that are identified in the ISP will be implemented, (b) Education, supervision, and training of waiver participants in health-related matters, and (c) Short-term or intermittent skilled or unskilled nursing services. #### Regulation .06 Covered Services for Day Habilitation. *COMAR 10.09.26.06* A. Day habilitation services shall be provided that are required and recommended in the waiver participant's IHP by licensed day habilitation programs and shall include the services listed in Regulation .05 of this chapter and in §B—D of this regulation. B. Transportation. (1) Transportation services shall be arranged for participants by the day habilitation services center staff. The center shall maximize the use of the following types of transportation services in an effort to achieve the least costly, yet appropriate, means of transportation for its participants: (a) Persons who live within walking distance of the day habilitation services center, and who are sufficiently mobile, shall be encouraged to walk; (b) Transportation supplied by family, friends, neighbors, or volunteers; (c) Free community transportation services. (2) After every effort made by the center to procure the types of transportation mentioned above has failed, the Department shall reimburse the day habilitation services provider for the waiver participant's traveling costs, to and from the center, by car, van, or specially equipped vehicles. It shall be the responsibility of the center to: (a) Arrange for use of public transportation, when appropriate; (b) Arrange special low-cost contract agreements with transportation providers to meet the transportation needs of the participants; (c) Group participants, when possible, not to exceed the seating capacity, in the same van or specially equipped vehicle, to minimize the cost of transportation. (3) Records shall clearly indicate both a primary transportation plan and an alternate plan. The center shall keep accurate records which include the type of transportation used by each participant. C. Nutrition. (1) Arrangements shall be made for participants to eat well balanced, palatable, properly prepared meals of sufficient quality and quantity. (2) Dietary counseling and education shall be available to all participants. (3) Nutrition services do not include a full meal regimen. D. Prevocational Services. (1) “Prevocational services” means those plans and interventions to assist a waiver participant in acquiring and maintaining basic work and work-related skills. The services are designed to prepare the waiver participant for unpaid or paid employment, but are not job task oriented. Prevocational services have habilitative objectives rather than explicit employment objectives. (2) Prevocational services include: (a) Training the waiver participant to follow directions, adapt to work routines, and carry out assigned duties in an effective and efficient manner; (b) Helping the waiver participant to acquire appropriate attitudes and work habits, including instruction in socially appropriate behaviors on and off the job site; (c) Assisting the waiver participant to adjust to the productive and social demands of the workplace; (d) Familiarizing the waiver participant with job production and performance requirements; (e) Providing transportation between the waiver participant's place of residence and the workplace when other forms of transportation are unavailable or inaccessible; (f) Providing mobility training, including the use of public transit and para-transit systems; and (g) Instructing waiver participants in appropriate use of job-related facilities such as break areas, lunch rooms or cafeterias, and restrooms. (3) Prevocational services are covered by the Program if: (a) The waiver participant previously resided in a State residential center or nursing facility and has a demonstrated earning capacity of less than 50 percent of the federal minimum wage, as determined in accordance with certification standards promulgated by the U.S. Department of Labor; (b) The services are an essential component of the waiver participant's IHP; (c) Work productivity is a secondary or tertiary goal of these services, subordinate to the acquisition and retention of work and work-related skills; (d) The provider's program is certified by the U.S. Department of Labor as a “work activity center”, in accordance with the Fair Labor Standards Act, §14(c); and (e) The waiver participant is engaging in compensable work as a necessary but subordinate part of the receipt of habilitation services. #### Regulation .07 Covered Services for Environmental Modifications. *COMAR 10.09.26.07* A. Environmental modifications shall be provided on a limited, one-time-only basis to the extent necessary to enable waiver participants with physical infirmities or disabilities to live safely in community homes as an alternative to institutionalization. B. The environmental modifications are limited to: (1) Installation of bathing and toilet-area grab bars in the home of a waiver participant who has physical infirmities or disabilities, when these mechanisms are not already installed; (2) Minor remodeling of the home to make it physically accessible for a waiver participant; (3) Construction of access ramps and railings for a waiver participant who uses a wheelchair or who has limited ambulatory ability; (4) Installation of detectable warnings on walking surfaces; (5) Adaptations to the electrical, telephone, and lighting systems; (6) Life-saving equipment for waiver participants; (7) Widening of doorways and halls for wheelchair use; and (8) Installation of chair glides along stairways. C. The services in this regulation are covered only if prior authorization is received from DDA, to assure that the proposed modifications are necessary to meet the waiver participant's needs and that the modifications conform with the requirements in these regulations. #### Regulation .08 Covered Services for Respite Care. *COMAR 10.09.26.08* A. Respite care may only be provided to waiver participants who receive residential habilitation or residential option services in their home or in an individual family care home. B. When respite care is received in a: (1) State residential center, it is limited to a total of 45 days within any 12-month period; (2) Community residence, it is limited to 14 consecutive days at a time and to a total of 28 days within any 12-month period. C. Room and board is included in the residential habilitation or residential option services provider's reimbursement for respite care. #### Regulation .08-1 Covered Services for Supported Employment. *COMAR 10.09.26.08-1* A. Supported employment services are available to waiver participants: (1) Who previously resided in a State residential center or nursing facility; (2) For whom competitive employment at or above the minimum wage is unlikely; and (3) Who, because of their disability, need ongoing post-employment support to perform in a work setting. B. Supported employment services are designed to assist a waiver participant with accessing and maintaining paid employment. The services shall be provided as required and recommended in the waiver participant's ISP, as an alternative model of day habilitation. C. Supported employment services include: (1) Individualized assessment and development of employment-related goals and objectives; (2) Individualized and group counseling; (3) Individualized job development, placement, and work adjustment services that produce an appropriate job match between the waiver participant and the waiver participant's employer; (4) On-the-job training in work and work-related skills required to perform the job; (5) Ongoing evaluation, supervision, and monitoring of the waiver participant's performance on the job which are required because of the waiver participant's disabilities, but which do not include supervisory activities rendered as a normal part of the business setting; (6) Ongoing support services necessary to assure job retention; (7) Training in related skills essential to obtaining and retaining employment, such as the effective use of community resources and break or lunch areas, and transportation and mobility training; (8) Transportation between the waiver participant's place of residence and the workplace, when other forms of transportation are unavailable or inaccessible; (9) Adaptive equipment necessary to obtain and retain employment; and (10) Community integration activities. #### Regulation .08-2 Covered Services for Residential Option Services. *COMAR 10.09.26.08-2* A. Residential option services are available as an alternative to residential habilitation for those waiver participants who: (1) Have followed DDA's application procedures according to COMAR 10.22.11; (2) Are determined by DDA to be able to live safely in a home of the waiver participant's choosing and who are in need of at least one residential option service; and (3) Elect, or have an authorized representative elect in the waiver participant's behalf, to receive residential option services. B. These services shall be provided, as required and recommended in the waiver participant's ISP, as being appropriate and necessary to assist the waiver participant in living successfully in a home of the waiver participant's choosing. Residential option services include the services specified in Sec. C--E of this regulation. C. Personal Assistance. (1) Services under COMAR 10.09.20 may not be reimbursed for a waiver participant receiving personal assistance under this chapter. (2) Personal assistance services provide necessary assistance for waiver participants living in their own homes or family homes to meet their daily living needs and to ensure adequate functioning in the community. They include the following services, when they do not have a habilitative objective: (a) Housekeeping assistance which is directly related to the waiver participant's developmental disability and which is necessary for the waiver participant's health and well-being in the home, such as: (i) Changing bed linens, (ii) Straightening the area used by the waiver participant, (iii) Doing the waiver participant's personal laundry and linens, and (iv) Maintenance of kitchen area if food preparation is necessary; (b) Menu planning, food shopping, meal preparation, and assistance with eating; (c) Personal hygiene and grooming, including oral and denture care, shaving, and care of skin, nails, and hair; (d) Cleaning and maintaining adaptive devices such as wheelchairs; and (e) Assurance of health and safety. D. Support Services. (1) Support services are necessary to aid the waiver participant to participate in community life as is typical in the community. (2) Support services include the following: (a) Guidance to optimize the waiver participant's capability of living in the community at home; (b) Facilitating community participation by assisting with linkages to community activities, organizations, or associations; (c) Assisting with budgeting, banking, tax preparation, and financial management; (d) Assisting with accessing and managing government and community resources; and (e) Assisting the waiver participant with securing and maintaining housing. E. 24-Hour Emergency Assistance. (1) These emergency assistance services are utilized to provide a waiver participant with access to a highly responsive form of back-up services in the event of an emergency, without dictating that the waiver participant be subject to on-site 24-hour supervision. (2) The access to 24-hour emergency assistance shall be adapted to the skills and needs of the waiver participant and may include the use of an emergency telephone number, a pager, or other appropriate technology. #### Regulation .08-3 Assistive Technology and Adaptive Equipment. *COMAR 10.09.26.08-3* A. This technology and equipment includes the assistive technology and adaptive equipment necessary to enable a waiver participant to live in the community and to participate in community activities, when this technology and equipment is not otherwise covered by the Program. B. The following items or services are included: (1) Equipment needed to adapt the waiver participant's or family's vehicle; (2) Purchase or rental of certain types of medical equipment to allow greater independence for a waiver participant; (3) A prompted assisted living system for a waiver participant; and (4) Assessments, specialized training, and upkeep and repair needed in conjunction with the use of these devices and equipment. #### Regulation .08-4 Covered Services for Intensive Behavior Management. *COMAR 10.09.26.08-4* Services shall be provided in accordance with COMAR 10.22.10. #### Regulation .08-5 Covered Services for Medical Day Care. *COMAR 10.09.26.08-5* A. Unit of service means a day of care in which the participant is certified present at the medical day care center for a minimum of 4 hours. B. Medical day care services shall be provided in accordance with COMAR 10.09.07. C. Medical day care services may be covered for not more than 5 days per week. #### Regulation .09 Conditions for Reimbursement. *COMAR 10.09.26.09* The Department shall reimburse for services in Regulations .04—.08-5 of this chapter when they are: A. Provided to waiver participants; B. With the exception of medical day care services, contained in the waiver participant's plan of care, approved initially and within 12 months after that by a: (1) Licensed physician; (2) Licensed physician's assistant or licensed nurse practitioner in accordance with applicable law; or (3) Qualified developmental disabilities professional; and C. With the exception of medical day care services, adequately described in the progress notes in the waiver participant's record, signed and dated by a qualified developmental disabilities professional. #### Regulation .10 Limitations. *COMAR 10.09.26.10* A. These regulations do not cover the following services: (1) Services available to waiver participants through programs funded under the Rehabilitation Act of 1973, §110, Public Law 94-142, or Education of the Handicapped Act, §602(16) and (17); (2) Services which are not part of a waiver participant's plan of care as established by a: (a) Licensed physician; (b) Licensed physician's assistant or licensed nurse practitioner in accordance with applicable law; or (c) Qualified developmental disabilities professional; (3) Services which are not included in Regulations .04—.08-5 of this chapter; and (4) Medical day care services which are not provided in accordance with COMAR 10.09.07. B. Providers are not entitled to reimbursement from the Program unless the waiver participant served by that provider is certified for medical eligibility by the Department or its designee and for financial eligibility by the Department of Human Services or its designee. C. Providers of services coordination services pursuant to these regulations may not be providers of any other service covered under this chapter for waiver participants. D. If the Program denies payment or requests repayment on the basis that an otherwise covered service was not programmatically necessary, the provider may not seek payment for that service from the recipient. E. Payment may not be made for the same date of service for respite care, personal assistance, and residential habilitation services rendered to a waiver participant. F. Payment may not be made for the same date of service to a residential habilitation services provider, a residential option services provider, and a personal care services provider under COMAR 10.09.20 for services rendered to a waiver participant. Qualified participants shall be given the option of residential habilitation or residential option services when they are determined to need residential services and qualify for both options. G. Payment may not be made for the same date of service for day habilitation services, supported employment services, and medical day care services under COMAR 10.09.07 rendered to a waiver participant. H. The following services shall be reimbursed only if preauthorized by DDA, or authorized by DDA after the fact in emergency situations: (1) Environmental modifications as covered under Regulation .07 of this chapter; (2) Assistive technology and adaptive equipment as covered under Regulation .08-3 of this chapter; and (3) Nursing services as covered under Regulations .05 or .06 of this chapter. #### Regulation .11 Participant Eligibility. *COMAR 10.09.26.11* A. Waiver participants shall meet the eligibility conditions of §B of this regulation, as well as Regulation .12 of this chapter. B. To be eligible for services under the Home and Community Based Services Waiver for the Developmentally Disabled, a person shall: (1) Be a recipient who, immediately before placement pursuant to these regulations, is residing in a: (a) State residential center; (b) Nursing facility and who is determined through the Preadmission Screening Annual Resident Review (PASARR) process to: (i) Have a developmental disability, and (ii) Be in need of specialized services pursuant to 42 CFR §483.136; or (c) Chronic care or nursing facility bed at a chronic care facility; or (d) Community setting and who is determined by DDA to be at risk of placement in a State residential center or in a chronic care or nursing facility bed at a chronic care facility, in accordance with DDA's process for eligibility determinations and for determination of service priority categories; (2) Be given a comprehensive evaluation as defined in Health-General Article, §7-104, Annotated Code of Maryland; (3) Have an approved plan of care; (4) Be selected by the DDA based on professionally accepted assessment measures, as appropriate to participate in the waiver program; (5) Choose, during an interpretive interview, between institutional or home and community based services; (6) Be certified for an ICF/IID level of care and have need for active treatment pursuant to 42 CFR §435.1009. #### Regulation .12 Medical Assistance Eligibility. *COMAR 10.09.26.12* A. Definitions. In this regulation, the following terms have the meanings indicated: (1) “Aged” means a person who is 65 years old or older. (2) “Blind” means having a condition in which a person is certified by an ophthalmologist as having either central visual acuity of 20/200 or less in the better eye with correcting glasses, or a field defect in which the peripheral field has contracted to such an extent that the widest diameter of the visual field subtends an angular distance of not greater than 20 degrees. (3) “Child” means an individual who is younger than 21 years old. (4) “Community spouse” means an individual who: (a) Lives in the community outside a medical institution; (b) Is not determined to meet the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of Title XIX of the Social Security Act; and (c) Is married to an institutionalized spouse. (5) “Continuous period of institutionalization” means: (a) At least 30 consecutive days of institutional care in a nursing facility or other medical institution; or (b) A determination that a spouse meets the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of Title XIX of the Social Security Act. (6) “Disabled” means the inability to perform any substantial gainful activity by reason of a medically determinable physical or mental impairment which is expected to result in death, or which has lasted or can be expected to last for a continuous period of not less than 12 months. (7) “Institutionalized spouse” means an individual who is married to a community spouse and who: (a) Is an inpatient in a nursing facility or other medical institution with a length of stay exceeding 30 days; or (b) Is determined to meet the criteria for participation in the Waiver for Individuals with Developmental Disabilities or any other waiver under §1915(c) of the Social Security Act. B. Financial eligibility for waiver participants is determined according to this regulation and COMAR 10.09.24, as cited in §§C—F of this regulation. C. Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as a: (1) Recipient of Supplemental Security Income (SSI); or (2) Member of a low income family with children, as described in §1931 of the Social Security Act. D. Medically Needy. An individual is eligible for waiver services as medically needy if the individual is receiving Medical Assistance as a medically needy person in accordance with COMAR 10.09.24.03D. E. Optionally Categorically Needy. (1) An individual is eligible for waiver services as optionally categorically needy, in accordance with 42 CFR §435.217, if the individual's countable income does not exceed 300 percent of the applicable payment rate for SSI, and the individual's countable resources do not exceed the SSI resource standard for one person. (2) For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one person. (3) For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income rules set forth in COMAR 10.09.24 which are applicable to a child or an aged, blind, or disabled individual who is institutionalized, with the exceptions specified at §E(9) of this regulation. (4) For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource rules set forth in COMAR 10.09.24, which are applicable to a child or an aged, blind, or disabled person who is institutionalized, with the exceptions specified at §E(9) of this regulation. (5) An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires. (6) The spousal impoverishment rules at COMAR 10.09.24.10-1 are applicable, with the differences specified in this regulation. (7) Medical Assistance eligibility shall be redetermined at least every 12 months. (8) As part of the determination and redetermination of Medical Assistance eligibility as optionally categorically needy, the Department of Human Services shall determine whether the applicant or recipient is eligible as a disabled person in accordance with COMAR 10.09.24.05E, unless the applicant or recipient is aged, blind, or a child, or has been determined as disabled by the Social Security Administration. (9) All provisions of COMAR 10.09.24 which are applicable to a child or an aged, blind, or disabled individual who is institutionalized are applicable to waiver applicants and participants who are considered as optionally categorically needy, with the following exceptions: (a) COMAR 10.09.24.04J(1), (2), and (3); (b) COMAR 10.09.24.04K; (c) COMAR 10.09.24.06B(2)(a)(ii); (d) COMAR 10.09.24.08G(1); (e) COMAR 10.09.24.08H; (f) COMAR 10.09.24.09; (g) COMAR 10.09.24.10; (h) COMAR 10.09.24.10-1; and (i) COMAR 10.09.24.15A-2(2). (10) Home Exclusion. The home, as defined in COMAR 10.09.24.08B, is not considered a countable resource under §E of this regulation if it is occupied by the waiver applicant or participant, the applicant's or participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or participant: (a) Child; (b) Parent; or (c) Sibling. F. Post-Eligibility Determination of Available Income for Optionally Categorically Needy. (1) The countable monthly income considered for the post-eligibility determination is calculated in accordance with rules at §E of this regulation and at COMAR 10.09.24 for institutionalized aged, blind, or disabled individuals, except that the income disregards specified at COMAR 10.09.24.07L are not applied. (2) For individuals eligible under §E of this regulation who reside in a residential habitation facility, the Department shall reduce its monthly payment for residential habilitation services by the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: (a) A personal needs allowance of $170 and the residential habilitation provider's monthly charge of at most $375 to the participant for room and board, as of the effective date of this amendment, either or both of which may be adjusted based on a schedule issued by the Department; (b) A spousal maintenance allowance in accordance with COMAR 10.09.24.10D(2)(b); and (c) Incurred medical expenses as specified at COMAR 10.09.24.10D(2)(d) and (e). (3) The Department shall determine the amount of available income to be paid by a participant towards the cost of care in a residential habilitation facility, based on the countable income remaining after deducting the amounts specified at §F(2) of this regulation. (4) The residential habilitation provider shall collect the participant's available income, in an amount which may not exceed the cost of residential habilitation services as determined by the Department for the participant. (5) The sum of the participant's cost of care contribution and the Department's payment may not exceed the total cost of residential rehabilitation services as determined by the Department for the participant. #### Regulation .13 Payment Procedures. *COMAR 10.09.26.13* A. Request for Payment. (1) All requests for payment of services rendered shall be submitted according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider. (2) Requests for payment shall be submitted as set forth in COMAR 10.09.36.04A. (3) Requests for payment shall include all units of service rendered to a waiver participant during the billing period. B. Billing Time Limitations. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. C. Payments. (1) Payments shall be made only to a qualified provider. Payment may not be made to a waiver participant, to individual professionals, or to other Program providers in connection with the provision of services specified in Regulations .04—.08-5 of this chapter. (2) Payments to service coordination providers shall be made according to a monthly waiver participant fee negotiated with the DDA. (3) Payments to residential habilitation service providers or to day habilitation service providers during their first year of operation, to most intensive behavior management providers, to some residential option providers, and to most supported employment providers which are licensed under COMAR 10.22.13 shall be made on a cost-related basis. This includes the following: (a) The Department shall pay these providers an interim payment based on allowable costs included in the human services agreement between DDA and the provider. The final cost settlement shall be actual allowable cost as determined by the Department through the audit and post-audit settlement process specified in COMAR 10.04.03 and 10.04.04. Tentative cost settlements may be made using unaudited annual reports submitted by providers to the Department. (b) Allowable costs are those costs incurred in the delivery of the covered services delineated in this chapter. (c) Return on equity is not an allowable cost. (d) A provider fee as specified in COMAR 10.09.41 is an allowable cost. (e) Room and board is an allowable cost only for respite care provided under Regulation .08 of this chapter. (f) Payments to these providers shall be on a quarterly basis. Providers shall submit quarterly reports of expenditures and requests for payment in the prescribed form to the Division of Program Cost and Analysis of the Maryland Department of Health. Providers shall receive funds in advance of expenditures anticipated in the ensuing quarter of the fiscal year. (4) Payments to most residential habilitation and day habilitation service providers, some intensive behavior management providers, and some supported employment and residential option providers shall be made according to the prospective payment system specified in COMAR 10.22.17. (5) Payments to medical day care service providers shall be in accordance with COMAR 10.09.07 and the waiver participant's approved plan of care. (6) Notwithstanding any other provision of these regulations, payment may not be made under these regulations for respite care or environmental modifications, as defined in Regulation .01B of this chapter, until the §1915(c) waiver amendment authorizing coverage of these services has been approved by the Health Care Financing Administration (HCFA). Once HCFA has approved the waiver amendment, payments may be made for respite care and environmental modifications retroactive to the effective date of the waiver amendment, but not earlier than April 1, 1991. (7) Notwithstanding any other provision of these regulations, payment may not be made under these regulations for residential option or intensive behavior management services, as defined in Regulation .01B of this chapter, or for services delivered to an individual being discharged or diverted from a chronic care facility, until the waiver amendment under the Social Security Act, Title XIX, §1915(c), authorizing coverage of these services has been approved by the Health Care Financing Administration (HCFA). Once HCFA has approved the waiver amendment, payments may be made retroactive to the effective date of the waiver amendment. D. Cost Reporting. (1) The provider shall maintain adequate financial records and statistical data according to generally accepted accounting principles and procedures. This system of accounts shall provide at a minimum: (a) Maintenance of a chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements. (b) Proper reference to supporting invoices, voucher, or other form of original evidence. (c) Maintenance of an appropriate time reporting system for all personnel and proper payroll authorizations and vouchers. (d) Provision for payment by check. When financial transactions involve numerous small expenditures an imprest petty cash fund shall be established, provided adequate supporting vouchers are maintained. (e) Maintenance of records of all assets. (f) Maintenance of records on a cash or accrual basis. (g) Maintenance of records as required by the Department. (h) Maintenance of all records concerning financial expense and income allocations shall be sufficiently documented by supporting data. Generally accepted accounting principles and the allocation principles of cost accounting theory shall be used for allocation of costs and income. (i) Maintenance of separate records of financial expense and income allocation applicable to: (i) Room and board; (ii) Covered services as specified in Regulations .05—.08-4 of this chapter. (2) The provider shall keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours. Records shall be maintained for 6 years after the period the cost report to which the materials apply is filed with the Department. (3) The provider shall: (a) Report direct and indirect costs applicable to recipient care. These reports shall clearly identify those direct and indirect costs and income applicable to: (i) Room and board; (ii) Covered services as specified in Regulations .05—.08-4 of this chapter. (b) Submit to the Division of Program Cost and Analysis of the Department a year-end reconciliation report of financial data in the prescribed form within 30 days of the end of the fiscal year unless the Department grants the provider an extension. E. Application of Recipient Income to Cost of Care. (1) The Department of Human Services shall determine the application of Optional Categorically Needy recipient's income toward the cost of services specified in Regulations .05 and .08 of this chapter pursuant to Regulation .12B of this chapter. (2) The residential habilitation services provider shall collect the Optional Categorically Needy recipient's available income as certified by the Department of Human Services. (3) The total of an Optional Categorically Needy recipient's available income to be applied to the cost of care and the Department's payment may not exceed the total cost of services specified in Regulations .05 and .08 of this chapter for that individual. #### Regulation .14 Recovery and Reimbursement. *COMAR 10.09.26.14* Recovery and reimbursement are as specified in COMAR 10.09.36. #### Regulation .15 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.26.15* Cause for suspension or removal and imposition of sanctions is as specified in COMAR 10.09.36. #### Regulation .16 Appeal Procedures. *COMAR 10.09.26.16* A. Appeal procedures for providers are as specified in COMAR 10.09.36. B. Persons filing appeals contending that they were not informed of their choice of services or that they were denied the service of their choice may file an appeal requesting a fair hearing under provisions contained in 42 CFR Part 431, Subpart E. #### Regulation .17 Interpretive Regulation. *COMAR 10.09.26.17* State regulations shall be interpreted as specified in COMAR 10.09.36. ### Chapter 27 — Home Care for Disabled Children Under a Model Waiver **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective May 10, 1985 (12:11 Md. R. 1041); emergency status extended at 12:19 Md. R. 1843 and 13:6 Md. R. 669; adopted permanently effective March 10, 1986 (13:5 Md. R. 543) **Administrative History:** Regulations .01—.10 amended as an emergency provision effective March 11, 1991 (18:7 Md. R. 765); amended permanently effective July 1, 1991 (18:12 Md. R. 1339) **Administrative History:** Regulation .01B amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .03B amended effective August 25, 1986 (13:17 Md. R. 1922); July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .04A amended effective August 25, 1986 (13:17 Md. R. 1922); July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .04B amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .06A—C amended effective July 1, 1989 (16:12 Md. R. 1336) **Administrative History:** Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .06C amended effective August 25, 1986 (13:17 Md. R. 1922) **Administrative History:** Regulation .07A amended effective August 25, 1986 (13:17 Md. R. 1922) **Administrative History:** Chapter revised effective July 1, 1991 (18:12 Md. R. 1339) **Administrative History:** Regulation .01B amended effective July 17, 2006 (33:14 Md. R. 1163) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077); September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .01B amended effective August 21, 2023 (50:16 Md. R. 725) **Administrative History:** Regulation .03B amended effective July 17, 2006 (33:14 Md. R. 1163) **Administrative History:** Regulation .03B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) **Administrative History:** Regulation .03B amended effective August 21, 2023 (50:16 Md. R. 725) **Administrative History:** Regulation .04A amended effective July 17, 2006 (33:14 Md. R. 1163); August 21, 2023 (50:16 Md. R. 725) **Administrative History:** Regulation .04A, B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) **Administrative History:** Regulation .05C amended effective August 21, 2023 (50:16 Md. R. 725) **Administrative History:** Regulation .06 amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .06A, C amended effective July 17, 2006 (33:14 Md. R. 1163) **Administrative History:** Regulation .06A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) **Administrative History:** Regulation .06A, C amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .06C amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1346); amended permanently effective October 8, 2007 (34:20 Md. R. 1739) **Administrative History:** Regulation .06C amended effective April 6, 2009 (36:7 Md. R. 523); February 8, 2010 (37:3 Md. R. 175); August 21, 2023 (50:16 Md. R. 725); November 24, 2025 (52:23 Md. R. 1139) #### Regulation .01 Definitions. *COMAR 10.09.27.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Certified nursing assistant” means an individual who: (a) Is certified by the Maryland Board of Nursing; and (b) Performs nursing tasks delegated by a registered nurse or licensed practical nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland. (2) “Department” means the Maryland Department of Health as defined in COMAR 10.09.36. (3) “Disabled child” means a chronically ill or severely impaired child, younger than 22 years old, whose illness or disability may not require 24-hour inpatient care, but which, in the absence of home care services, may precipitate admission to or prolong stay in a hospital, nursing facility, or other long term care facility. (4) “Face-to-face” means contact with a participant that occurs in-person or via audio-visual telehealth in accordance with COMAR 10.09.49. (5) “Home care” means a comprehensive package of medical and health-related services provided under the Program, pursuant to the authority of a model waiver for certain disabled children, as an alternative to institutionalization. (6) “Home care case management” means locating, coordinating, and monitoring home care services for disabled children and includes: (a) Screening of referrals and identification of individuals requiring home care services; (b) Completing a comprehensive assessment to determine the appropriateness of home care services; (c) Convening the multidisciplinary team and coordinating the development of a comprehensive plan of care; (d) Determining individual case cost effectiveness; (e) Identifying and maximizing informal sources of care; (f) Ongoing monitoring of the delivery of services specified in the plan of care to determine the appropriateness of the type, amount, and duration of services rendered; (g) Completing the semiannual utilization review procedure specified in Regulation .03B(1)(c)(ii) of this chapter; and (h) Providing in-home assessments as specified in Regulation .04A(2)(e) of this chapter. (7) “Home care case manager” means the agency administering a program of services for disabled children authorized under Title V of the Social Security Act, or the agency's designee, which provides or arranges for the provision of home care case management services for participants, develops training and community education programs, and establishes standards and procedures for quality assurance and monitoring. (8) “Home care provider” means the principal physician or the individual or agency providing nursing, home health aide services, medical supplies and equipment, or home care case management services to disabled children. (9) “Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10. (10) “Home health aide” means an individual who meets all the conditions of participation specified in: (a) 42 CFR §484.36; and (b) Health Occupations Article, Title 8, Annotated Code of Maryland. (11) “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36. (12) “Medical day care” has the meaning stated in COMAR 10.09.07. (13) “Medical day care center” has the meaning stated in COMAR 10.09.07. (14) “Medicare” means Medicare as defined in COMAR 10.09.36. (15) “Model Waiver” means the document and any amendments to it submitted by the Department to, and approved by, the Department of Health and Human Services which authorize the waiver of certain statutory requirements limiting eligibility and covered services under the Medicaid State plan pursuant to §1915(c) of the Social Security Act. (16) “Multidisciplinary team” means the group consisting of the participant or the participant's legal representative or representatives, or all of these, home care providers, and the participant's principal physician or the physician designated by the principal physician, and other providers of health-related services, as appropriate, that establishes and updates the plan of care under the overall direction and coordination of the home care case manager and assesses the appropriateness of the participant's discharge to or continuation of home care. (17) “Necessary” means necessary as defined in COMAR 10.09.36. (18) “Nurse” means a person who is licensed as a registered nurse or licensed practical nurse in the jurisdiction in which services are provided. (19) “Nursing care plan” means a plan developed by a registered nurse that identifies: (a) The patient's diagnoses and needs; (b) The goals to be achieved; and (c) The interventions required to meet the patient's medical condition. (20) “Participant” means a recipient: (a) Whose initial eligibility for services under this chapter is established as a disabled child certified by the Department or its designee as requiring nursing home care under the Program pursuant to COMAR 10.09.10 or COMAR 10.09.11, or inpatient hospital care pursuant to COMAR 10.09.92—10.09.95, but whose medical condition does not require 24-hour inpatient care unless home care services are not available; (b) Who, once eligibility is established, remains eligible for services under this chapter as long as he or she continues to meet the certification and care requirements of §B(15)(a) of this regulation, regardless of age; (c) Who, but for the services listed in Regulation .04 of this chapter, requires and would be receiving institutional care reimbursed under the Program; (d) Who, before receipt of services under this chapter, was: (i) A patient in a hospital, nursing facility, or other long-term care facility; or (ii) Formerly a patient in a hospital, nursing facility, or other long-term facility who, upon discharge, has continuously received other insurance reimbursement for skilled nursing or home health aide services which has precluded the need for admission to the waiver; (e) Whose disabilities and needs for home care cannot be adequately and appropriately addressed through provider services otherwise available under the Program; and (f) Who meets the eligibility requirements of these regulations or was receiving services under this chapter as of December 1, 1988 or under COMAR 10.09.31 as of December 31, 1990 and continues to meet the certification and care requirements specified in this chapter. (21) “Plan of care” means the written home care plan which is: (a) Composed of a comprehensive assessment of the participant's health status including: (i) All pertinent diagnoses; (ii) Prognosis; (iii) Functional status; (iv) Level of activity permitted; (v) Type, frequency, and duration of services required; (vi) Treatment goals for each type of service; (vii) Medications; and (viii) Treatments; (b) Established by the multidisciplinary team; (c) Approved, signed, and dated by the participant's principal physician; (d) Approved, signed, and dated by the participant or the participant's legally authorized representative, or both; (e) Approved, signed, and date by the Department; and (f) Revised 90 days after approval of the initial plan of care and semiannually thereafter, unless the home care case manager decides that a different review period is appropriate. (22) “Principal physician” means the specialty physician who is part of the interdisciplinary team and who approves the plan of care for the participant. (23) “Program” means the Program as defined in COMAR 10.09.36. (24) “Progress note” means a dated written notation by a home care provider which: (a) Summarizes facts about the care given and the patient's responses during a given period of time; (b) Specifically addresses the established goals of treatment; (c) Is consistent with the participant's plan of care; (d) Is written and signed during the course of care; and (e) Is provided to the home care case management agency to become a part of the agency's permanent record for the participant. (25) “Provider” means a provider as defined in COMAR 10.09.36. (26) “Provider agreement” means a contract between the Department and the provider of home care, specifying the services to be performed, methods of operation, and financial and legal requirements which shall be in force before Program participation. (27) “Recipient” means a recipient as defined in COMAR 10.09.36. (28) “Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05. (29) “Secretary” means the Secretary of Health. (30) “Specialty physician” means a licensed physician who meets one of the following criteria: (a) Has been declared board certified, or board eligible, by a member board of the American Board of Medical Specialties, and has demonstrated experience in the care of disabled children; or (b) Has been declared board certified, or board eligible, by a specialty board approved by the Advisory Board of Osteopathic Specialists and the Board of Trustees of the American Osteopathic Association, and has demonstrated experience in the care of disabled children. (31) “Supervision” means: (a) Authoritative procedural guidance by a licensed registered nurse for the accomplishment of a function or activity; and (b) The process of critical watching, directing, and evaluating an individual's performance. (32) “Telehealth” has the meaning stated in COMAR 10.09.49.02. (33) “Waiver enrollment process” means those procedures necessary to establish participant eligibility pursuant to Regulation .05 of this chapter. (34) “Witness” means the recipient or an individual who, on behalf of the recipient, is able to personally verify that the recipient received private duty nursing services, home health aide services, or certified nursing assistant services. #### Regulation .02 Licensing Requirements. *COMAR 10.09.27.02* Providers shall meet all licensing requirements specified in COMAR 10.09.36. #### Regulation .03 Conditions for Participation. *COMAR 10.09.27.03* A. General requirements for participation in the Medical Assistance Program are that providers shall meet all conditions for participation specified in COMAR 10.09.36. B. Specific requirements for participation in the Program as a provider of home care services are as follows: (1) The home care case management provider shall: (a) Have a written agreement with each participant which includes the following: (i) A description of the types, amount, frequency, and duration of home care services to be provided to the participant as ordered by the principal physician and specified in the approved plan of care; (ii) A statement that the participant or responsible representatives shall have access to the individual plan of care and shall be involved in its development and periodic review; (iii) The name, address, telephone number, and Medical Assistance number of the participant; (iv) The dated signatures of the participant or legally authorized representative, and the provider representative; (v) A statement that utilization of available services and selection among approved enrolled providers is subject to participant choice; (vi) A statement that services will at all times be provided without discrimination with regard to race, color, age, sex, national origin, marital status, or physical or mental handicap. (b) Be available to participants in-person at least 8 hours a day, 5 days a week with established hours of operation. (c) Have written and implemented formalized policies and procedures developed before participation in the Program concerning the following areas: (i) Medical records for each participant which include at a minimum the application for home care, plan of care, orders for home care services, documentation of nursing observations at least every 30 days, social history, and home care cost worksheets establishing initial participant eligibility and continued eligibility on a quarterly basis; (ii) Utilization review which includes the development of a home care review procedure completed every 6 months for all participants to evaluate the appropriateness of home care, the efficiency, adequacy, and coordination of home care services, with the objective of achieving the least costly yet appropriate delivery of services under the Program. (d) Convene the multidisciplinary team which: (i) Upon receipt of the principal physician's orders assesses the appropriateness of home care for the participant; (ii) Determines the medical, psychological, social, and functional status of each participant; (iii) Develops an individual plan of care in conjunction with the principal physician's orders; (iv) Coordinates at least one in-person meeting annually, unless otherwise authorized by the Department; (v) Unless otherwise excepted in §B(1)(d)(iv) of this regulation, may meet in-person or via telehealth; and (vi) Reviews and updates the individual plan of care in accordance with Regulation .01B(16) of this chapter. (e) Provide for in-home assessments, via an in-person visit or telehealth, on a quarterly basis or as determined necessary by the principal physician. (f) Conducts at least two in-person visits annually, unless otherwise authorized by the Department. (g) Not be a provider of medical supplies and equipment or nursing services. (2) Shift private duty nursing, certified nursing assistant, and home health aide providers shall: (a) Meet all conditions for participation set forth in: (i) COMAR 10.09.53.03; or (ii) COMAR 10.09.69; (b) Participate in interdisciplinary team meetings; (c) Ensure timesheets are signed by the individual rendering services; (d) Ensure a nurse, a certified nursing assistant, or a home health aide is not scheduled to work for more than 16 consecutive hours and the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department; (e) Provide for in-home assessments by the principal physician, on a quarterly basis or as determined necessary by the principal physician. (f) Either be a: (i) Residential service agency licensed in accordance with COMAR 10.07.05; or (ii) Home health agency licensed in accordance with COMAR 10.07.10 which meets the conditions of participation specified in 42 CFR §484.36; (g) Demonstrate the capacity to arrange for the provision of home health aide services in the amount and level required in the participant's plan of care including the establishment of a contingency plan to assure coverage as specified in the plan of care; (h) Demonstrate sufficient specialized training and experience in the care of individuals with disabilities necessary to deliver the level of services required by participants; and (i) Demonstrate, on a continuing basis, the ability to competently carry out services in the plan of care subject to review by the home care case manager or the home care case manager's designee. (3) Medical day care providers shall meet all conditions for participation set forth in COMAR 10.09.07. (4) The provider of home care services shall: (a) Deliver services in-person unless expressly authorized to render services via telehealth; and (b) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. #### Regulation .04 Covered Services. *COMAR 10.09.27.04* A. The Program reimburses for home care services which include the following: (1) Shift nursing services provided by a licensed registered nurse or a licensed practical nurse if: (a) The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a licensed nurse for a shift of 4 or more continuous hours; (b) The services are delivered to the participant in the participant's home or other setting when normal life activities take the participant outside the home; (c) Services are provided to a model waiver participant who is 21 years old or older; (d) Services are rendered in accordance with COMAR 10.09.53; (e) Services are rendered in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland; (f) Sufficient documentation concerning the services provided is maintained by the registered nurse or licensed practical nurse, including: (i) Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and (ii) Signed and dated progress notes which are reviewed monthly by the nurse supervisor; (g) The nurse is not scheduled to work for more than 16 consecutive hours and is off 8 or more hours before starting another shift; (h) Services are rendered by a licensed registered or practical nurse certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; (i) Services are preauthorized in accordance with the criteria set forth in COMAR 10.09.53.06; and (j) Supervisory visits are conducted at least monthly in the participant's home or another site where the participant is receiving nursing services with a minimum of two visits per year with the primary nurse present; (2) Home care case management which includes: (a) Arranging, monitoring, and coordinating the health-related services necessary to meet the identified needs of the participant as specified in the participant's plan of care; (b) Establishing, in conjunction with the other members of the multidisciplinary team, the plan of care necessary to deinstitutionalize or maintain, or both of these, the participant at home; (c) Reviewing the plan of care for appropriateness of the level, amount, type, quality, and frequency of services provided as well as monitoring the cost effectiveness of home care for each participant; (d) Arranging for scheduled reviews and approval of the plan of care by the principal physician; and (e) Providing for in-home assessments, via an in-person visit or telehealth as authorized by the Department, on a quarterly basis, or as determined necessary by the principal physician; (3) Participation by the principal physician in the plan of care meetings including: (a) Prescribing home care services; and (b) Approving and signing the plan of care; (4) Home health aide services which include: (a) The performance of simple procedures as an extension of therapy services; (b) Ambulation and exercise; (c) Household services essential to health care at home; (d) Assistance with medications that are ordinarily self-administered; (e) Assistance with activities of daily living when performed in conjunction with other delegated nursing services; (f) Other health care services properly delegated by a licensed nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, if: (i) The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a home health aide for a shift of 4 or more continuous hours; (ii) Services are provided by an unlicensed individual who meets all the conditions of participation specified by the Medicare program in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland; (iii) Services are rendered by a home health aide certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; (iv) The home health aide is not scheduled to work for more than 16 consecutive hours and has 8 hours or more off before starting another shift; (v) Sufficient documentation is maintained by the home health aide including verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and signed and dated progress notes which are reviewed every 2 weeks by the nurse supervisor; (vi) Supervisory visits are conducted every 2 weeks and documented by a registered nurse with a minimum of two visits with the primary aide present; (vii) The services are included in the model waiver participant's plan of care developed by the case manager; and (viii) Services are preauthorized by the Department; (5) Certified nursing assistant services if: (a) The certified nursing assistant is certified by the Maryland Board of Nursing and meets all the requirements to render services pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; (b) The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of a certified nursing assistant for a shift of 4 or more continuous hours; (c) The services provided include but are not limited to: (i) Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or (ii) Other health care services properly delegated by a licensed nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; (d) Services are rendered by a certified nursing assistant certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; (e) The certified nursing assistant is not scheduled to work for more than 16 consecutive hours and has 8 hours or more off before starting another shift; (f) Sufficient documentation concerning the services provided is maintained by the certified nursing assistant including: (i) Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and (ii) Signed and dated progress notes which are reviewed every 2 weeks by the nurse supervisor; (g) Supervisory visits are conducted every 2 weeks and documented by a registered nurse with a minimum of two visits with the primary aide present; (h) The services are included in the model waiver participant's plan of care developed by the case manager; and (i) Services are preauthorized by the Department; (6) Delegated nursing services provided by a certified nursing assistant or home health aide who is also a certified medical technician when: (a) The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of the certified nursing assistant or home health aide for at least 2 or more continuous hours; (b) The services provided include but are not limited to: (i) Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or (ii) Other nursing services properly delegated by a nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11; (c) Sufficient documentation is maintained by the certified nursing assistant or home health aide, including signed and dated progress notes which are reviewed by the nurse supervisor; and (d) Supervisory visits are conducted and documented by a registered nurse supervisor in accordance with COMAR 10.27.09 and 10.27.11; and (7) Medical day care when services are: (a) Included in the Model Waiver participant's approved and signed plan of care; and (b) Rendered in accordance with COMAR 10.09.07. B. The Department will reimburse for the services listed in §A(1)—(2) and (4)—(6) of this regulation when they are: (1) Ordered by the participant's principal physician as part of a written home care plan, which is included in the provider's permanent record for the participant and is reviewed by the principal physician in accordance with Regulation .01B(16) of this chapter; (2) Medically necessary; (3) Adequately described in progress notes in the participant's medical record, signed, and dated by the individual providing care; (4) Provided instead of institutional care to recipients certified and annually recertified as requiring nursing facility care under the Program as specified in COMAR 10.09.10 or 10.09.11; and (5) Provided in the amount, duration, and frequency specified in the plan of care subject to approval by the Program. #### Regulation .05 Participant Eligibility. *COMAR 10.09.27.05* A. Requirements. Model waiver participants shall meets the financial eligibility requirements under §B, C, or D of this regulation and the nonfinancial requirements of §§E and F of this regulation. B. Categorically needy eligibility recipients of supplemental security income benefits under Title XVI of the Social Security Act are eligible for medical assistance benefits as categorically needy individuals as specified in COMAR 10.09.24. C. Optional Categorically Needy Eligibility. Individuals who do not qualify for supplemental security income benefits may apply for eligibility under the provision of this section and applicable sections of COMAR 10.09.24, as follows: (1) COMAR 10.09.24, exclusive of Regulations .06, .08L, .09, and .10, applies for the purpose of determining eligibility as an optional categorically needy individual. (2) An individual is eligible for medical assistance benefits as an optional categorically needy individual if they comply with the requirements of §C(1) of this regulation, including the requirement that resources not exceed the applicable standard for supplemental security income eligibility, and if the income of the individual before the disregards specified in §C(3) of this regulation does not exceed 300 percent of the supplemental security income benefit amount payable under §1611(b)(i) of the Social Security Act to an individual in their own home who has no income or resources. (3) Disregards. The following disregards are subtracted from income computed according to COMAR 10.09.24.07A—K in order to determine the amount of the income of recipients qualifying under this section to be applied toward the cost of services specified in Regulation .04 of this chapter. (a) The amount of the medically needy income standard for one person established under COMAR 10.09.24.07; (b) Amounts for incurred expenses for medical or remedial care that are not subject to payment by a third party, including: (i) Medicare and other health insurance premiums, deductibles, or co-insurance charges, and (ii) Necessary medical or remedial care recognized under State law but not covered under the Program. D. Medically Needy Eligibility. Financial eligibility for individuals who do not qualify as categorically needy recipients as specified in §B, or optional categorically needy recipients as specified in §C of this regulation is determined according to provisions of COMAR 10.09.24 relating to determinations of medically needy eligibility. E. To be eligible to receive services under the model waiver for disabled children a person shall: (1) Be certified and annually recertified as requiring nursing home care under the Program pursuant to COMAR 10.09.10 or COMAR 10.09.11; (2) Be approved by the Department or its designee as appropriate for home care based on a comprehensive assessment of the participant's health status as set forth in Regulation .01B(15) of this chapter; (3) Choose between institutional or home care services under the Program; (4) Be a recipient: (a) For whom it can reasonably be expected that the cost of home care services would not exceed the cost of the level of care provided in an institution, and (b) Whose plan of care meets the requirement of §F of this regulation relating to cost effective coverage of home care services. F. Eligibility for coverage of home care services for disabled children is limited to individuals for whom the projected total cost that would be incurred by the Program if the coverage and services specified in this chapter were not available is greater, on an annual basis, than the projected total cost that would be incurred by the Program for the services listed in Regulation .04 of this chapter and all other services available under the Program based on the following formula: #### Regulation .06 Payment Procedures. *COMAR 10.09.27.06* A. Payment procedures as set forth in COMAR 10.09.36 apply. B. Payments. (1) Payments shall be made directly to a qualified provider. (2) Providers shall be paid the lesser of: (a) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rate established according to the fee schedule published by the Department. C. Rates. (1) The Department shall publish a fee schedule for services covered under this chapter that shall be publicly available and updated at least annually or upon any changes made by the Department. (2) Effective July 1, 2022, rates for services governed by this chapter are as follows: (a) For home health aide or certified nursing assistant services provided to one participant: (i) $5.0809 per 15 minutes of services; or (ii) If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $6.1208 per 15 minutes of services; (b) For home health aide or certified nursing assistant services provided to two or more participants in the same residence: (i) $3.5044 per 15 minutes of services per participant; or (ii) If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $4.2232 per 15 minutes of service per participant; and (c) Payments for home care case management services shall be made as follows: (i) Waiver enrollment process — $1,181.61; (ii) First month of home care case management — $1,181.61; and (iii) The second and any subsequent month of home care case management — $590.80. (3) Effective January 1, 2024 through June 30, 2024, rates for services governed by this chapter are as follows: (a) For home health aide or certified nursing assistant services provided to one participant: (i) $5.4874 per 15 minutes of services; or (ii) $6.6105 per 15 minutes of service if the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician; (b) For home health aide or certified nursing assistant services provided to two or more participants in the same residence: (i) $3.7848 per 15 minutes of services per participant; or (ii) $4.5611 per 15 minutes of service per participant if the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician; and (c) Payments for home care case management services shall be made as follows: (i) Waiver enrollment process — $1,276.14; (ii) First month of home care case management — $1,276.14; and (iii) The second and any subsequent month of home care case management — $638.06. (4) Effective July 1, 2024, rates for services governed by this chapter are as follows: (a) For home health aide or certified nursing assistant services provided to one participant: (i) $5.6520 per 15 minutes of services; or (ii) If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $6.8088 per 15 minutes of services; (b) For home health aide or certified nursing assistant services provided to two or more participants in the same residence: (i) $3.8983 per 15 minutes of services per participant; or (ii) If the services are rendered by a home health aide or certified nursing assistant who is also a certified medical technician, $4.6979 per 15 minutes of service per participant; and (c) Payments for home care case management services shall be made as follows: (i) Waiver enrollment process — $1,314.42; (ii) First month of home care case management — $1,314.42; and (iii) The second and any subsequent month of home care case management — $657.21. (5) Subject to the limitations of the State budget, the Program’s rates as specified in this regulation shall increase by 4 percent each year through Fiscal Year 2026. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.27.07* Recovery and reimbursement shall be as specified in COMAR 10.09.36. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.27.08* Cause for suspension or removal and imposition of sanctions shall be as specified in COMAR 10.09.36. #### Regulation .09 Appeal Procedures. *COMAR 10.09.27.09* Appeal procedures shall be as specified in COMAR 10.09.36. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.27.10* State regulations shall be interpreted as specified in COMAR 10.09.36. ### Chapter 28 — Applied Behavior Analysis Services **Authority:** Health-General Article, §§2-104(b), 2-105(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: November 7, 2016 (43:22 Md. R. 1218) **Administrative History:** Regulation .01B amended effective March 12, 2018 (45:5 Md. R. 285); June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049); December 11, 2023 (50:24 Md. R. 1041) **Administrative History:** Regulation .02A amended effective December 12, 2022 (49:25 Md. R. 1049) **Administrative History:** Regulation .02H, I amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049) **Administrative History:** Regulation .02J adopted effective December 11, 2023 (50:24 Md. R. 1041) **Administrative History:** Regulation .03B amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049) **Administrative History:** Regulation .04 amended effective December 12, 2022 (49:25 Md. R. 1049) **Administrative History:** Regulation .04B amended effective March 12, 2018 (45:5 Md. R. 285); June 17, 2019 (46:12 Md. R. 542); December 11, 2025 (52:24 Md. R. 1197 **Administrative History:** Regulation .04B, C amended effective December 11, 2023 (50:24 Md. R. 1041) **Administrative History:** Regulation .05B, C amended effective March 12, 2018 (45:5 Md. R. 285) **Administrative History:** Regulation .05D amended effective December 12, 2022 (49:25 Md. R. 1049) **Administrative History:** Regulation .05F adopted effective March 12, 2018 (45:5 Md. R. 285) **Administrative History:** Regulation .06 amended effective March 12, 2018 (45:5 Md. R. 285); December 11, 2023 (50:24 Md. R. 1041); December 11, 2025 (52:24 Md. R. 1197) **Administrative History:** Regulation .06B amended effective December 12, 2022 (49:25 Md. R. 1049) **Administrative History:** Regulation .06F amended effective June 17, 2019 (46:12 Md. R. 542); December 12, 2022 (49:25 Md. R. 1049) **Administrative History:** Regulation .06G adopted effective December 12, 2022 (49:25 Md. R. 1049) #### Regulation .01 Definitions. *COMAR 10.09.28.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Applied Behavior Analysis (ABA). (a) “Applied behavior analysis (ABA)” means the design, implementation, and evaluation of environmental modifications using behavioral stimuli and consequences to produce socially significant improvements in human behavior. (b) “Applied behavior analysis (ABA)” includes the direct observations, measurement, and functional analysis of the relations between environment and behavior. (2) “ABA program” means an association, partnership, corporation, or unincorporated group that includes: (a) A licensed psychologist or an LBA; and (b) A BCaBA, RBT, or a BT. (3) “Autism spectrum disorder (ASD)” means a group of developmental disorders: (a) Characterized by persistent deficits in social communication and social interaction across multiple contexts; (b) Characterized by restricted, repetitive patterns of behavior, interests, or activities; and (c) Whose symptoms cause clinically significant impairment in social, occupational, or other important areas of current functioning. (4) “Behavior Analyst Certification Board (BACB)” means the Board accredited by the National Commission for Certifying Agencies that credentials and certifies an LBA or BCaBA, or registers an RBT. (5) “Behavior technician (BT)” means a paraprofessional in the process of obtaining BACB certification who delivers ABA services that are provided to participants with ASD under the supervision of a licensed: (a) Psychologist; (b) BCBA-D; or (c) BCBA. (6) “Board certified assistant behavior analyst (BCaBA)” means a paraprofessional who: (a) Delivers ABA treatments that are provided to participants with ASD under the supervision of: (i) A licensed psychologist; or (ii) An LBA; and (b) Obtained a BACB certification. (7) “Board certified behavior analyst (BCBA)” means a licensed professional who: (a) Renders and provides direction for ABA services that are provided to participants with ASD; and (b) Obtained a BACB certification. (8) “Board certified behavior analyst-doctoral (BCBA-D)” means a licensed professional who: (a) Renders and provides direction for ABA treatments that are provided to participants with ASD; and (b) Obtained a BACB certification with a doctoral-level credential. (9) “Caregiver” means a willing and able individual who is trained in providing care to the participant. (10) “Comprehensive diagnostic evaluation” means an assessment performed by a qualified health care professional with the help of validated instruments, which includes: (a) A direct observation of the participant; (b) Interviews with the participant’s parent or caregiver; (c) Documentation of developmental history, psychosocial history, and current functioning across major domains of development; and (d) A confirmed diagnosis of Autism Spectrum Disorder (ASD). (11) “Custodial care” means care that is provided: (a) To assist in the activities of daily living, such as bathing, dressing, eating, and maintaining personal hygiene; (b) For maintaining the participant's safety; and (c) By individuals without professional skills or training. (12) “Department” means the Maryland Department of Health. (13) “Designee” means the entity designated by the Department to manage the public behavioral health system on behalf of the Department. (14) “Direction of a technician” means the in-person monitoring of a BCaBA, RBT, or BT, performed by a licensed psychologist or an LBA. (15) “Early and periodic screening, diagnosis, and treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects, physical and mental illnesses, and conditions discovered by EPSDT screening services. (16) “Family” means an adult who: (a) Lives with or provides care to the participant; and (b) Is not paid to provide the care. (17) “HIPAA” means the Health Insurance Portability and Accountability Act, a federal law enacted on August 21, 1996, whose purpose is to improve the efficiency and effectiveness of the health care system by standardizing the electronic exchange of administrative and financial data, provide security requirements for transmitted information, and protect the privacy of identifiable health information. (18) “Individualized education program (IEP)” means a written description of special education and related services to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.03B and 13A.05.01.09. (19) “Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family pursuant to COMAR 13A.13.01.03B. (20) “Intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that provides health-related services or health rehabilitative services for individuals with intellectual disabilities or related conditions. (21) “Licensed behavior analyst (LBA)” means a licensed professional who is certified by the Behavior Analyst Certification Board (BACB) to be a: (a) BCBA; or (b) BCBA-D. (22) Maladaptive Behavior. (a) “Maladaptive behavior” means behavior that interferes with the participant's activities of daily living or ability to adjust or participate in particular settings. (b) “Maladaptive behavior” includes behaviors such as self-injurious behavior, aggression, tantrums, stereotypies, and rituals. (23) “Maryland Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended. (24) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not for the convenience of the participant, family, or provider. (25) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., as amended. (26) “Parent” means the adult representative of a participant and includes: (a) A biological or adoptive parent; (b) A legal guardian; (c) An individual acting in the place of a parent, such as a grandparent or stepparent with whom the participant lives, including those relatives or stepparents who are foster parents; (d) An individual appointed as the parent surrogate in accordance with Education Article, §8-412, Annotated Code of Maryland, for matters within the scope of the Individuals with Disabilities Education Act; or (e) Another individual responsible for a participant's welfare. (27) “Participant” means an eligible individual who is enrolled in the Program. (28) “Plan for generalization” means a component of the treatment plan whose goal is the expansion of a participant's performance ability beyond the initial conditions set for acquisition of a skill that can occur across people, places, and materials used for teaching. (29) “Preauthorized” means the approval required from the Department, or its designee, before a provider renders services in order to receive reimbursement for services. (30) “Program” means the Maryland Medical Assistance Program. (31) “Provider” means a person certified to provide ABA services to participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. (32) “Psychologist” means an individual who is: (a) Licensed and legally authorized to practice psychology under Health Occupations Article, Title 18, Annotated Code of Maryland; or (b) Licensed and legally authorized to practice psychology in the state where the service is rendered. (33) “Qualified health care professional” means a developmental pediatrician, pediatrician, pediatric neurologist, child psychiatrist, clinical psychologist, neuropsychologist, or a nurse practitioner with training and experience to diagnose ASD. (34) “Registered behavior technician (RBT)” means a paraprofessional certified by the BACB who delivers ABA services that are provided to participants with ASD under the supervision of: (a) A licensed psychologist; or (b) An LBA. (35) “Remote access technology” means the use of HIPAA compliant technological methods to provide auditory and visual connection between a licensed psychologist or an LBA, who is not directly present, and a BCaBA, RBT, or BT when services are being provided at the participant’s home. (36) “Remote direction of a technician” means the monitoring of a BCaBA, RBT, or BT, who is physically with the participant, performed via synchronous two-way audio-visual remote access technology by a licensed psychologist or an LBA. (37) “Treatment plan” means an individualized written plan for ABA services which includes the components specified in Regulation .03 of this chapter.. #### Regulation .02 Provider Qualifications and Conditions for Participation. *COMAR 10.09.28.02* A. To participate in the Program, a provider shall: (1) Meet all conditions for participation as set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. An ABA provider shall be licensed, certified, or otherwise legally authorized to provide ABA services in the jurisdiction in which the services are provided. C. An ABA provider may not have current sanctions or current disciplinary actions imposed by: (1) The jurisdictional licensing or certification authority; (2) Medicare Program; (3) Maryland Medical Assistance Program; or (4) Other federally funded healthcare program. D. An ABA provider shall have a completed Criminal Justice Information System's criminal background check. E. A licensed psychologist who renders ABA services shall: (1) Be licensed by the Maryland Board of Examiners of Psychologists; and (2) Act within the licensee's scope of practice. F. A BCBA-D provider who renders ABA services shall: (1) Be licensed by the Maryland Board of Professional Counselors and Therapists; and (2) Have a current certification of BCBA-D by the BACB. G. A BCBA provider who renders ABA services shall: (1) Be licensed by the Maryland Board of Professional Counselors and Therapists; and (2) Have a current certification of BCBA by the BACB. H. A BCaBA provider who renders ABA services shall: (1) Have a current certification of BCaBA by the BACB; (2) Work under the direction of: (a) A licensed psychologist; or (b) An LBA; and (3) Have the supervisory relationship documented in writing. I. An RBT provider who renders ABA services shall: (1) Be 18 years old or older; (2) Be currently registered by the BACB; (3) Have a high school degree or national equivalent; (4) Work under the direction of: (a) A licensed psychologist; or (b) An LBA; and (5) Have the supervisory relationship documented in writing. J. A BT provider who renders ABA services shall: (1) Be 18 years old or older; (2) Obtain BACB registration within 90 days of enrollment with Maryland Medicaid; (3) Have a high school degree or national equivalent; (4) Work under the direction of: (a) A licensed psychologist; or (b) An LBA; and (5) Have the supervisory relationship documented in writing. #### Regulation .03 Participant Eligibility. *COMAR 10.09.28.03* A. A participant shall meet the eligibility conditions set forth in §B of this regulation. B. To qualify for ABA services, a participant shall: (1) Be younger than 21 years old; (2) Live in the community; (3) Be diagnosed with an ASD by a qualified health care professional; (4) Exhibit the presence of maladaptive behavior or developmental skills deficits that significantly interferes with home, school, or community activities; (5) Be medically stable and not require 24-hour medical or nursing monitoring or procedures provided in a hospital or an ICF-IID; (6) Have a comprehensive diagnostic evaluation by a qualified health care professional; (7) Be referred for ABA services by a licensed health care professional; and (8) Have a completed ABA treatment plan that shall: (a) Be participant-centered and family-centered, culturally competent, and based on individualized goals; (b) Consider the participant's age, school attendance requirements, and other daily activities; (c) Be developed by: (i) A licensed psychologist; or (ii) An LBA; (d) Ensure that the interventions are consistent with ABA techniques; (e) Delineate both the frequency of baseline targeted behaviors and the behavior intervention plan to address the behaviors; (f) Identify long-term goals, short-term goals, and objectives that: (i) Are behaviorally defined; (ii) Are customized to the participant; (iii) Are measurable; and (iv) Are based upon clinical observations; (g) Identify the methods that will be used to measure achievement of behavior goals, objectives, and estimated timeframes; (h) Identify the schedule of services planned, including number of hours per week and the providers responsible for delivering the services; (i) Include: (i) Care coordination involving the participant's parent or caregiver and other professionals as applicable; (ii) Support and training of the participant's parent or caregiver; (iii) A plan for generalization; and (iv) Measurable discharge criteria. #### Regulation .04 Covered Services. *COMAR 10.09.28.04* A. The Program covers the ABA services set forth in §B of this regulation when the services are: (1) Medically necessary; (2) Preauthorized by the Program or its designee; (3) Delivered in accordance with the participant's treatment plan; and (4) Supported by documentation of consent to treatment from the participant or the participant’s parent or guardian. B. The Program covers the following ABA services: (1) An ABA assessment, which is a behavior identification assessment that: (a) Is administered in person with a participant and the participant's parent or caregiver by: (i) A licensed psychologist; or (ii) An LBA; (b) Addresses the behavioral needs for ABA services; and (c) Includes: (i) An interview, direct observation, record review, data collection, and analysis; (ii) An assessment of the participant's current level of functioning, skills deficits, and maladaptive behaviors using validated instruments; (iii) Analysis of past data; (iv) Scoring and interpreting the assessment; (v) Preparing the treatment plan and report; and (vi) Discussion of the findings; (2) A behavior identification supporting assessment which is a follow-up assessment that is administered: (a) In person, by an RBT, BT, or BCaBA, with a participant present; and (b) Under the direction of a licensed psychologist or an LBA; (3) An exposure behavior identification supporting assessment which is a follow-up assessment that: (a) Is conducted on a participant with specific, severe destructive behaviors in a structured, safe environment; (b) Is administered in person by a licensed psychologist or an LBA with the assistance of two or more BCaBAs, RBTs, or BTs; (c) Exposes the participant to a customized series of social and environmental conditions associated with the destructive behaviors; and (d) Uses structured testing to examine events, cues, responses, and consequences associated with the behaviors; (4) An adaptive behavior treatment with protocol modification which is an in-person service that: (a) Is conducted on a participant with specific, severe destructive behaviors in an environment that is: (i) Customized; (ii) Structured; and (iii) Safe; (b) Is administered in-person by a licensed psychologist or an LBA with the assistance of two or more BCaBAs, RBTs, or BTs; (c) Includes in-person direction of two or more technicians eliciting behavioral effects or exposing the participant to specific environmental conditions and treatment; and (d) Refines and modifies ineffective components of the treatment; (5) Group adaptive behavior treatment by protocol which is an in-person service provided to a group of two or more participants by: (a) A licensed psychologist; (b) An LBA; or (c) A BCaBA, RBT, or BT under the direction of a licensed psychologist or an LBA utilizing a behavioral intervention protocol designed in advance by the psychologist or an LBA who may or may not provide in-person direction of a technician during the treatment; (6) Multiple-family group adaptive behavior treatment guidance that: (a) Is provided in person with parents or caregivers of multiple participants without the presence of the participants by: (i) A licensed psychologist; or (ii) An LBA; (b) Identifies maladaptive behaviors and skills deficits; (c) Instructs parents or caregivers on how to utilize ABA treatments to reduce maladaptive behaviors and skill deficits; and (d) Is performed in person for at least 25 percent of the session time each month; (7) Family adaptive behavior treatment guidance which: (a) Is provided in person or remotely with a participant’s parent or caregiver, with or without the presence of the participant by: (i) A licensed psychologist; (ii) An LBA; or (iii) A BCaBA; (b) Identifies maladaptive behaviors and skills deficits; (c) Instructs the parent or caregiver on how to utilize ABA strategies to reduce maladaptive behaviors and skill deficits; and (d) Is performed in person for at least 25 percent of the session time each month; (8) A behavior identification reassessment which is a follow-up assessment that: (a) Is performed in person with a participant and a participant's parent or caregiver every 180 days by: (i) A licensed psychologist; or (ii) An LBA; (b) Evaluates the progress toward each behavior treatment goal using objective, quantifiable measures and includes the results of validated instruments; (c) Includes a revision of the treatment plan based on progress; and (d) Includes a clinical recommendation as to whether ABA services continue to be medically necessary; (9) Group adaptive behavior treatment with protocol modification which is a service that is: (a) Provided in person to multiple participants by: (i) A licensed psychologist; or (ii) An LBA; (b) Focused on social skills training; and (c) Aimed at identifying and targeting individual participants social deficits and maladaptive behaviors; (10) Adaptive behavior treatment direction of a technician which is the clinical direction and oversight of a BCaBA, RBT, or a BT by a licensed psychologist or an LBA that: (a) Requires the licensed psychologist or the LBA to directly or remotely observe the BCaBA, RBT, or BT administering ABA services to the participant, group of participants, parent, or caregiver; (b) Is performed on an ongoing basis, equal to at least 10 percent of the amount of hours that the BCaBA, RBT, or BT is providing direct ABA services to the participant, or group of participants; and (c) Is performed in person for at least 25 percent of the session time each month; (11) Adaptive behavior treatment by protocol which is an in-person service provided to a participant by: (a) A licensed psychologist or an LBA; or (b) A BCaBA, RBT, or BT under the direction of a licensed psychologist or an LBA utilizing a behavioral intervention designed in advance by the licensed psychologist or an LBA, who may or may not provide in-person or remote direction during the treatment; and (12) Adaptive behavior treatment planning which is an ongoing indirect service that: (a) Is performed by a licensed psychologist or an LBA; and (b) Includes: (i) Development and revision of the treatment plan and goals; (ii) Data analysis; and (iii) Real-time, direct communication and coordination with the participant's other service providers. C. ABA services shall only be provided by a licensed psychologist, LBA, BCaBA, RBT, or BT. D. ABA services shall be initially preauthorized for a period not to exceed 180 days. E. Additional preauthorization beyond the initial preauthorization shall be requested every 180 days, in advance of the expiration of the previous preauthorization. F. The provider shall maintain documentation of each service delivered under the participant's treatment plan, which, at a minimum, includes: (1) The location, date, start time, and end time of the service; (2) A brief description of the service provided, including reference to the treatment plan; (3) A description of the participant's behaviors or symptoms in measurable terms; (4) A description of the participant’s parent or caregiver’s participation in the ABA treatment sessions, including the parent or the caregiver’s name and relationship to the participant, date, and time of participation or notification of the participant’s parent or caregiver’s consent to be absent; and (5) A legible signature, along with the printed or typed name of the individual providing care, with the appropriate title. #### Regulation .05 Limitations. *COMAR 10.09.28.05* A. ABA services are only available to participants under the EPSDT program. B. ABA services shall be delivered in a home or community setting, including a clinic, when medically necessary. C. The provider may not bill the Program for: (1) Services that are: (a) Provided in: (i) A hospital; (ii) An institution for mental disease; (iii) An ICF-IID; (iv) A crisis residential program; (v) A residential treatment center; (vi) A 24-hour, 365-day residential program funded with federal, State, or local government funds; or (vii) Nonconventional settings, including but not limited to resorts, spas, and camps; (b) Rendered when measurable functional improvement or continued clinical benefit is not met, and treatment is not deemed necessary; (c) Not preauthorized by the Department or its designee; (d) Beyond the provider's scope of practice; (e) Rendered but not documented in accordance to Regulation .04 of this chapter; (f) Rendered by mail or telephone; (2) Services whose purpose is vocationally based or recreationally based; (3) Respite services; (4) Custodial care; (5) Completion of forms and reports; (6) Broken or missed appointments; (7) Travel to and from site of service; and (8) Services which duplicate a service that a participant is receiving under another medical care program. D. The participant’s parent or caregiver shall be trained to reinforce ABA services for the participant in a clinically effective manner. E. Services shall be discontinued if no longer medically necessary because: (1) Long-term treatment goals and objectives are achieved; or (2) Participant is not demonstrating progress towards treatment goals and objectives and measurable functional improvement is no longer expected. F. The provider shall obtain approval by the Department or its designee for remote supervision. #### Regulation .06 Payment Procedures. *COMAR 10.09.28.06* A. The provider shall follow all procedures in accordance with COMAR 10.09.36. B. The Program shall provide fee-for-service reimbursement for covered ABA services to the following ABA providers who meet the conditions for participation set forth in Regulation .02 of this chapter: (1) ABA program; (2) Individual licensed psychologist; and (3) Individual LBA. C. Reimbursement for ABA services may not be made directly to a BCaBA, RBT, or BT rendering ABA services. D. Reimbursement for ABA services may not be made to, or on behalf of services rendered by, the participant's parent or caregiver. E. The Program shall pay for covered services: (1) At the lesser of the provider's customary charge to the general public unless the services are free to the individuals not covered by Medicaid; or (2) In accordance with COMAR 10.09.36.06. F. Effective July 1, 2022 through June 30, 2023, reimbursement for ABA services covered under this chapter is as follows: (1) Behavior identification assessment at a rate of $33.46 per 15 minutes; (2) Behavior identification assessment follow-up at a rate of $16.73 per 15 minutes; (3) Exposure behavior identification supporting assessment at a rate of $45.63 per 15 minutes; (4) Adaptive exposure behavior treatment with protocol modification at a rate of $45.63 per 15 minutes; (5) Group adaptive behavior treatment by protocol at a rate of: (a) $9.13 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; (b) $7.30 per 15 minutes, per participant, when provided by a BCaBA; and (c) $6.08 per 15 minutes, per participant, when provided by an RBT or BT; (6) Adaptive behavior treatment with protocol modification at a rate of $33.46 per 15 minutes; (7) Multiple-family group adaptive behavior treatment guidance at a rate of $11.26 per 15 minutes per family; (8) Family adaptive behavior treatment guidance with the participant present at a rate of: (a) $33.46 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $18.25 per 15 minutes when provided by a BCaBA; (9) Family adaptive behavior treatment guidance without the participant present at a rate of: (a) $18.25 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $10.65 per 15 minutes when provided by a BCaBA; (10) Behavior identification reassessment at a rate of $33.46 per 15 minutes; (11) Group adaptive treatment with protocol modification at a rate of $9.13 per 15 minutes per participant; (12) Adaptive behavior treatment direction at a rate of $33.46 per 15 minutes; (13) Adaptive behavior treatment by protocol at a rate of: (a) $21.30 per 15 minutes when provided by a licensed psychologist or an LBA; (b) $18.25 per 15 minutes when provided by a BCaBA; and (c) $16.73 per 15 minutes when provided by an RBT or BT; and (14) Adaptive behavior treatment planning: (a) At a rate of $33.46 per 15 minutes; and (b) For a maximum of 4 hours per month. G. Effective July 1, 2023 through December 31, 2023, reimbursement for ABA services covered under this chapter is as follows: (1) Behavior identification assessment at a rate of $34.46 per 15 minutes; (2) Behavior identification assessment follow-up at a rate of $17.23 per 15 minutes; (3) Exposure behavior identification supporting assessment at a rate of $47.00 per 15 minutes; (4) Adaptive exposure behavior treatment with protocol modification at a rate of $47.00 per 15 minutes; (5) Group adaptive behavior treatment by protocol at a rate of: (a) $9.40 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; (b) $7.52 per 15 minutes, per participant, when provided by a BCaBA; and (c) $6.26 per 15 minutes, per participant, when provided by an RBT or BT; (6) Adaptive behavior treatment with protocol modification at a rate of $33.46 per 15 minutes; (7) Multiple-family group adaptive behavior treatment guidance at a rate of $11.60 per 15 minutes per family; (8) Family adaptive behavior treatment guidance with the participant present at a rate of: (a) $34.46 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $18.80 per 15 minutes when provided by a BCaBA; (9) Family adaptive behavior treatment guidance without the participant present at a rate of: (a) $18.80 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $10.97 per 15 minutes when provided by a BCaBA; (10) Behavior identification reassessment at a rate of $34.46 per 15 minutes; (11) Group adaptive treatment with protocol modification at a rate of $9.40 per 15 minutes per participant; (12) Adaptive behavior treatment direction at a rate of $34.46 per 15 minutes; (13) Adaptive behavior treatment by protocol at a rate of: (a) $21.94 per 15 minutes when provided by a licensed psychologist or an LBA; (b) $18.80 per 15 minutes when provided by a BCaBA; and (c) $17.23 per 15 minutes when provided by an RBT or BT; and (14) Adaptive behavior treatment planning: (a) At a rate of $34.46 per 15 minutes; and (b) For a maximum of 4 hours per month. H. Effective January 1, 2024 through June 30, 2024, reimbursement for ABA services covered under this chapter is as follows: (1) Behavior identification assessment at a rate of $37.22 per 15 minutes; (2) Behavior identification assessment follow-up at a rate of $18.61 per 15 minutes; (3) Exposure behavior identification supporting assessment at a rate of $50.76 per 15 minutes; (4) Adaptive exposure behavior treatment with protocol modification at a rate of $50.76 per 15 minutes; (5) Group adaptive behavior treatment by protocol at a rate of: (a) $10.15 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; (b) $8.12 per 15 minutes, per participant, when provided by a BCaBA; and (c) $6.76 per 15 minutes, per participant, when provided by an RBT or BT; (6) Adaptive behavior treatment with protocol modification at a rate of $37.22 per 15 minutes; (7) Multiple-family group adaptive behavior treatment guidance at a rate of $12.53 per 15 minutes per family; (8) Family adaptive behavior treatment guidance with the participant present at a rate of: (a) $37.22 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $20.30 per 15 minutes when provided by a BCaBA; (9) Family adaptive behavior treatment guidance without the participant present at a rate of: (a) $20.30 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $11.85 per 15 minutes when provided by a BCaBA; (10) Behavior identification reassessment at a rate of $37.22 per 15 minutes; (11) Group adaptive treatment with protocol modification at a rate of $10.15 per 15 minutes per participant; (12) Adaptive behavior treatment direction at a rate of $37.22 per 15 minutes; (13) Adaptive behavior treatment by protocol at a rate of: (a) $23.70 per 15 minutes when provided by a licensed psychologist or an LBA; (b) $20.30 per 15 minutes when provided by a BCaBA; and (c) $18.61 per 15 minutes when provided by an RBT or BT; and (14) Adaptive behavior treatment planning: (a) At a rate of $37.22 per 15 minutes; and (b) For a maximum of 4 hours per month. I. Effective July 1, 2024, reimbursement for ABA services covered under this chapter is as follows: (1) Behavior identification assessment at a rate of $38.34 per 15 minutes; (2) Behavior identification assessment follow-up at a rate of $19.17 per 15 minutes; (3) Exposure behavior identification supporting assessment at a rate of $52.28 per 15 minutes; (4) Adaptive exposure behavior treatment with protocol modification at a rate of $52.28 per 15 minutes; (5) Group adaptive behavior treatment by protocol at a rate of: (a) $10.45 per 15 minutes, per participant, when provided by a licensed psychologist or an LBA; (b) $8.36 per 15 minutes, per participant, when provided by a BCaBA; and (c) $6.96 per 15 minutes, per participant, when provided by an RBT or BT; (6) Adaptive behavior treatment with protocol modification at a rate of $38.34 per 15 minutes; (7) Multiple-family group adaptive behavior treatment guidance at a rate of $12.91 per 15 minutes per family; (8) Family adaptive behavior treatment guidance with the participant present at a rate of: (a) $38.34 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $20.91 per 15 minutes when provided by a BCaBA; (9) Family adaptive behavior treatment guidance without the participant present at a rate of: (a) $20.91 per 15 minutes when provided by a licensed psychologist or an LBA; and (b) $12.21 per 15 minutes when provided by a BCaBA; (10) Behavior identification reassessment at a rate of $38.34 per 15 minutes; (11) Group adaptive treatment with protocol modification at a rate of $10.45 per 15 minutes per participant; (12) Adaptive behavior treatment direction at a rate of $38.34 per 15 minutes; (13) Adaptive behavior treatment by protocol at a rate of: (a) $24.41 per 15 minutes when provided by a licensed psychologist or an LBA; (b) $20.91 per 15 minutes when provided by a BCaBA; and (c) $19.17 per 15 minutes when provided by an RBT or BT; and (14) Adaptive behavior treatment planning: (a) At a rate of $38.34 per 15 minutes; and (b) For a maximum of 4 hours per month. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.28.07* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.28.08* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeals Procedures. *COMAR 10.09.28.09* Appeal procedures are as set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.28.10* This chapter shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 29 — Residential Treatment Center Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective July 1, 1986 (13:13 Md. R. 1474); adopted permanently effective December 1, 1986 (13:24 Md. R. 2559) **Administrative History:** Regulation .01 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1150); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .01B amended effective April 5, 2010 (37:7 Md. R. 571); April 4, 2022 (49:7 Md. R. 465) **Administrative History:** Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulations .03—.06 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1150); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulations .03, .04, .07 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1383); amended permanently effective November 1, 1992 (19:21 Md. R. 1891) **Administrative History:** Regulation .04E amended effective April 4, 2022 (49:7 Md. R. 465) **Administrative History:** Regulation .05 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .06C amended effective April 4, 2022 (49:7 Md. R. 465) **Administrative History:** Regulation .07A amended effective February 6, 1989 (16:2 Md. R. 159) **Administrative History:** Regulation .07A amended as an emergency provision effective November 17, 1995 (22:25 Md. R. 1958); adopted permanently effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .07A amended effective February 12, 2007 (34:3 Md. R. 298); April 5, 2010 (37:7 Md. R. 571); July 4, 2016 (43:13 Md. R. 712); April 4, 2022 (49:7 Md. R. 465); August 7, 2023 (50:15 Md. R. 682) **Administrative History:** Regulation .07F amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07H amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .07H amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .09D adopted effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .10 amended effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulations .12—.14 adopted effective November 23, 1992 (19:23 Md. R. 2041) **Administrative History:** Regulations .12B and .13 amended as an emergency provision effective November 17, 1995 (22:25 Md. R. 1958); adopted permanently effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .13B, C amended effective February 12, 2007 (34:3 Md. R. 298) **Administrative History:** Regulation .15 adopted effective February 12, 2007 (34:3 Md. R. 298) #### Regulation .01 Definitions. *COMAR 10.09.29.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Active treatment” means inpatient psychiatric services which involve implementation of a professionally developed and supervised individual plan of care described in 42 CFR §441.155, that is: (a) Developed and implemented no later than 14 days after admission; and (b) Designed to achieve the recipient's discharge from inpatient status at the earliest possible time. (2) “Acute psychiatric services” mean psychiatric services rendered in response to a severe psychiatric condition requiring intervention in order to bring the patient's symptoms under control. (3) “Admissions team” means an independent team that certifies the need for services (as specified in 42 CFR §§441.152 and 441.153). The certification shall be made by an independent team that: (a) Includes a physician; (b) Has competence in diagnosis and treatment of mental illness, preferably in child psychiatry; and (c) Has knowledge of the individual's situation. (3-1) “Children's residential treatment center” means a residential treatment center that admits patients 12 years old and younger. (4) “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Department of Human Services” means the department of State government encompassing the Family Investment Administration, the Social Services Administration, and the Child Support Enforcement Administration. (6) “Family Investment Administration” means the administrative unit of the Department of Human Services and its affiliated local departments responsible for determining a person's eligibility for Medical assistance. (7) “Individual plan of care” means a written plan developed for each recipient in accordance with 42 CFR §§456.180—456.181, and §§456.280—456.281, and defined in 42 CFR §441.155 (individual plan of care). The plan of care shall: (a) Be based on a diagnostic evaluation that includes examination of the medical, psychological, social, behavioral, and developmental aspects of the recipient's situation and reflects the need for inpatient psychiatric care; (b) Be developed by a team of professionals in consultation with the recipient and the recipient's parents, legal guardians, or others in whose care the recipient will be released after discharge; (c) State treatment objectives; (d) Prescribe an integrated program of therapies, activities, and experiences designed to meet the objectives; and (e) Include, at an appropriate time, post-discharge plans and coordination of inpatient services with partial discharge plans and related community services to ensure continuity of care with the recipient's family, school, and community upon discharge. (8) “Local department of social services” means that unit of the Baltimore City or county social services department under the supervision of the Family Investment Administration. (9) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (10) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (10-1) “Mental health services” means those services described in COMAR 10.09.59.06 rendered to treat an individual for a diagnosis set forth in COMAR 10.67.08.02M. (11) “Physician” means an individual who is currently licensed to practice medicine in the state in which his practice is located. (12) “Preauthorization” means an approval required from the Department or its designee and transmitted to the provider before services can be rendered. (13) “Program” means the Maryland Medical Assistance Program, which administers comprehensive medical and health-related benefits to indigent and medically indigent persons. (14) “Provider” means a residential treatment center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. (15) “Recipient” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. (16) “Recipient under 21 years old” means a recipient who is either: (a) Under 21 years old; or (b) Twenty-one years old and received residential treatment center services immediately before the recipient reached age 21. The recipient continues to be recognized as a recipient under 21 years old until the earlier of the date the recipient either: (i) No longer requires inpatient psychiatric services; or (ii) Reaches 22 years old. (17) “Residential treatment center” means any institution which falls within the jurisdiction of Health-General Article, §19-308, Annotated Code of Maryland, and is licensed as required by COMAR 10.07.04 or other applicable standards established by the state in which the service is provided. (18) “Secretary” means the Secretary of Health. #### Regulation .02 Licensure Requirements. *COMAR 10.09.29.02* A. In order to participate in the Program a provider shall: (1) Be licensed by the Department in accordance with requirements of Health-General Article, §19-308, Annotated Code of Maryland; (2) Meet the standards established by COMAR 10.07.04; and (3) Obtain other licenses as may be required by applicable State and local laws. B. A physician providing services in a residential treatment center shall be licensed and legally authorized to practice medicine in the state in which the service is provided. #### Regulation .03 General Conditions for Participation. *COMAR 10.09.29.03* To participate in the Program as a residential treatment center for emotionally disturbed children and adolescents, a provider shall: A. Meet the requirements for participation as defined in 42 CFR §440.160 (inpatient psychiatric services for individuals under 21 years old) and have acute psychiatric services that meet the requirements of 42 CFR Part 441, Subpart D (inpatient psychiatric services for individuals under 21 years old in psychiatric facilities or programs). B. Be accredited by the Joint Commission on Accreditation of Healthcare Organizations. C. Meet the applicable conditions and requirements of Regulation .04 of this chapter. D. Apply for participation in the Program by completing the application form designated by the Program. E. Be approved for participation and be assigned a provider account number by the Department. F. Have a current written agreement with the Program. G. Verify the licenses and credentials of all professionals employed by or under contract with the residential treatment center to provide services. H. Verify the recipient's eligibility. I. Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap, unless limitations are those specifically required by 42 CFR Subpart D. J. Place no restriction on a recipient's right to select providers of the recipient's choice. K. Have a written individual plan of care for each recipient as specifically defined by 42 CFR §441.155, and developed by an interdisciplinary team of physicians and other personnel as required in 42 CFR §441.156. The plan shall be reviewed every 30 days by the team to determine that services being provided are or were required on an inpatient basis, and recommend changes in the plan as indicated by the recipient's overall adjustment as an inpatient. The team shall be capable of: (1) Assessing the recipient's immediate and long-range therapeutic needs, developmental priorities, and personal strengths and liabilities; (2) Assessing the potential resources of the recipient's family which includes the recipient's parents, legal guardians, or others in whose care the recipient will be released after discharge; (3) Setting treatment objectives; and (4) Prescribing therapeutic modalities to achieve the plan's objectives. L. Employ for purposes of developing an individual plan of care an interdisciplinary team which shall: (1) Include as a minimum: (a) A Board-eligible or Board-certified psychiatrist, (b) A clinical psychologist who has a doctoral degree and a physician licensed to practice medicine or osteopathy, or (c) A physician licensed to practice medicine or osteopathy with specialized training and experience in the diagnosis and treatment of mental diseases, and a psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association; (2) Include one of the following: (a) A psychiatric social worker, (b) A registered nurse with specialized training or 1 year's experience in treating mentally ill individuals, (c) An occupational therapist who is licensed, if required by the State, and who has specialized training or 1 year of experience in treating mentally ill individuals, (d) A psychologist who has a master's degree in clinical psychology or who has been certified by the State or by the State psychological association. M. Maintain adequate administrative and medical records for a minimum of 6 years and make them available upon request to the Department or its designee. Adequate administrative and medical records are defined as having documentation sufficient in quantity, scope, and detail to confirm that the residential treatment center services are provided in accordance with this regulation. N. Not knowingly contract or employ a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance recipients unless prior written approval has been received from the Department. O. Accept payment by the Department as payment in full for services rendered and make no additional charge to any person for covered service. P. Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the recipient or his family. Q. Agree that if the Program denies payment due to late billing, the provider may not seek payment from the recipient or his family. R. Meet the requirements for admission to regional institutes for children and adolescents, established by COMAR 10.21.06. S. Agree that if the Program denies payment due to the provider's failure to satisfy mandatory federal requirements as specified in 42 CFR Part 441, Subpart D—Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs, the provider may not seek payment from the recipient or his family. T. Comply with all requirements for the delivery of mental health services contained in COMAR 10.67.08. #### Regulation .04 Covered Services. *COMAR 10.09.29.04* The Program covers inpatient psychiatric services for the diagnosis, active treatment, and care of recipients under 21 years old with mental disease when the services are: A. Medically necessary; B. Performed under the direction of a physician; C. Certified as necessary by an admissions team before the recipient's admission to the residential treatment center; D. In the case of a recipient already residing in the residential treatment center, certified as necessary by the team developing the individual plan of care in accordance with 42 CFR §441.153(b); E. For the treatment of a mental illness listed in COMAR 10.67.08.02M. #### Regulation .05 Limitations. *COMAR 10.09.29.05* The Program does not cover the following: A. Services not specified in Regulation .04 of this chapter; B. Services not medically necessary; C. Investigational and experimental drugs and procedures; D. A day of inpatient care solely for the purpose of performing diagnostic tests that can be performed on an outpatient basis; E. Admissions with a primary diagnosis of alcoholism, drug addiction, or severe brain damage, or the following diagnoses in the ICD-9-CM, (1) 294.0—Amnestic syndrome, (2) 294.8—Other specified organic brain syndromes (chronic), (3) 294.9—Unspecified organic brain syndromes (chronic), (4) 299.00—299.8—Psychoses with origin specific to childhood, (5) 301.7—Antisocial personality disorder, (6) 302.70—302.79—Psychosexual dysfunction, (7) 306.0—306.9—Physiological malfunction arising from mental factor, (8) 307.0—Special symptoms or syndromes, not elsewhere classified (NEC), (9) 307.2 —Tics, (10) 307.40—307.49—Specific disorders of sleep of nonorganic origin, (11) 307.9—Other and unspecified special symptoms or syndromes (NEC), or (12) 316—Psychic factors associated with disease classified elsewhere; F. Days of care for recipients remaining in the residential treatment center beyond the length of stay certified by the team which develops the individual plan of care; G. Psychiatric services to recipients over 21 years old except as specified in Regulation .01B(16) of this chapter. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.29.06* The following procedures or services require preauthorization: A. Out-of-State admissions. Adequate documentation shall be provided demonstrating that the placement meets one of the conditions as follows: (1) Effective services at an in-State facility are not available; (2) For similar services, an inpatient placement is not currently available in Maryland; or (3) The recipient resides out-of-State and the cost for the out-of-State service is comparable to the cost of similar services in Maryland. B. Services which are determined by Medicare to be ineffective, unsafe, or without proven clinical value are generally presumed to be not medically necessary, but will be preauthorized if the provider can satisfactorily document sufficient medical necessity except as specified in Regulation .05C of this chapter. C. All admissions, which shall comply with the requirements under COMAR 10.09.59.08 for preauthorization. #### Regulation .07 Payment Procedures. *COMAR 10.09.29.07* A. Reimbursement Principles. (1) The Department will make no direct reimbursement to any State-operated residential treatment center for recipients. The Department will claim federal fund recoveries from the Department of Health and Human Services for services to federally eligible Title XIX patients in these residential treatment centers. (2) The Department will pay the residential treatment center the lesser of the provider’s customary charge or the provider’s per diem costs for covered services according to the principles established under Title XVIII of the Social Security Act, as required in 42 CFR 413, or on the basis of charges not to exceed $750 per day effective July 1, 2021 through December 31, 2022, or $850 per day effective January 1, 2023. The average increase in the Department’s reimbursement to the provider per inpatient day for each fiscal year over the cost-settled rate for the previous fiscal year, State Fiscal Year 2019 final cost per diem effective July 1, 2021, may not exceed the rate of increase of the Hospital Wage and Price Index plus 1 percentage point, described in 42 CFR §413.40. The target rate percentage increase for each calendar year will equal the prospectively estimated increase in the Hospital Wage and Price Index (market basket index) for each year, plus 1 percentage point. If the service is free to individuals not covered by Medicaid: (a) The provider: (i) May charge the Program; and (ii) Shall be reimbursed in accordance with the provisions of this regulation; and (b) The provider’s reimbursement is not limited to the provider’s customary charge. (3) An in-State children’s residential treatment center shall be reimbursed the lesser of: (a) The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; (b) The provider’s per diem cost for covered services established in accordance with Medicare principles of reasonable cost reimbursement as described in 42 CFR 413; (c) Effective July 1, 2021, $750 per day; or (d) Effective January 1, 2023, $850 per day. (4) The Department rebases prices in §A(2) and (3) of this regulation between every 2 and 4 years. Prices may be rebased more frequently if the State determines that there is an error in the data or in the calculation that results in a substantial difference in payment, or if a significant change in provider behavior or costs has resulted in payment that is inequitable across providers. In years in which rates are not rebased, rates are subject to annual indexing. (5) For purposes of §A(3)(b) of this regulation, the percentage increase in the Department's cost reimbursement to the provider, per inpatient day for each cost reporting year over the cost-settled payment rate for the previous cost reporting year, State Fiscal Year 2019 final cost per diem effective July 1, 2021, may not exceed the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, plus 1 percent. (6) The rate stated in §A(2) and (3)(c) of this regulation shall be updated annually for each provider's cost reporting period by the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system. (7) Effective July 1, 2021, the rate stated in §A(2) and (3)(c) of this regulation shall be updated annually for each provider's cost reporting period by the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, plus 1 percent. (8) Out-of-State Providers. To be reimbursed for services provided to Maryland Medical Assistance recipients, an out-of-State provider shall be licensed or formally approved as a psychiatric facility or as an inpatient program in a psychiatric facility, either of which is accredited by the Joint Commission on Accreditation of Healthcare Organizations. B. Recipient's Contribution. (1) The local department of social services or the State-operated facility's fiscal agent shall determine the amount the recipient has available to pay toward the cost of medical or remedial care for inpatient services, and so inform the provider. (2) The provider shall collect from the recipient that amount as shown available on the designated form. (3) The provider may not collect a total amount, including the amount the recipient has available and the Department's payment, which exceeds the provider's rate established by the Department or its designee. (4) The provider shall show to the Department sums collected from the recipient. C. The provider shall submit request for payment on the form designated by the Department. D. The provider shall submit, with invoices, properly completed attachments as requested by the Department. E. A provider may not bill the Program a charge exceeding that charged the general public for similar services. F. The provider may not bill the Department for: (1) Completion of forms and reports; (2) Broken or missed appointments; or (3) Professional services rendered by mail or telephone. G. The Department will make no direct payment to the recipient. H. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. I. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.29.08* A. If the recipient has insurance, or if any other person is obligated either legally or contractually to pay for, or to reimburse, the recipient for any services covered by this chapter, the provider shall seek payment from that source. If payment is made by both the Program and the insurance or other source, the provider shall report, within 15 days after the close of each month, on a form designated by the Department, the amount paid by the Program, and the insurance or the other source, whichever is less, and refund the total amount of the lesser of the two payments reported to the Program at that time. B. If refund of a payment as specified in §A, of this regulation, is not made, the Department will have the right to reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.29.09* A. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the Program; (2) Withholding of payment by the Program; (3) Removal from the Program; (4) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department will take similar action. C. A provider who voluntarily withdraws from the Program or is removed or suspended from the Program according to this regulation shall notify recipients that it no longer honors Medical Assistance cards before it renders additional services. D. The Department shall give to the provider reasonable written notice of the Department’s intention to impose sanctions. In the notice, the Department shall: (1) Establish the: (a) Effective date of the proposed action; and (b) Reasons for the proposed action; and (2) Advise the provider of the right to appeal. #### Regulation .10 Appeal Procedures. *COMAR 10.09.29.10* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.29.11* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. #### Regulation .12 Cost Reporting. *COMAR 10.09.29.12* A. The provider shall: (1) Include, for purposes of cost finding, direct and indirect costs applicable to recipient care; (2) In the cost report, specifically identify costs associated with related organizations; (3) Maintain adequate financial records and statistical data, according to generally accepted accounting principles and procedures, which shall provide, as a minimum: (a) Maintenance of: (i) A chronological cash receipts and disbursements journal in sufficient detail to show the exact nature of the receipts and disbursements, (ii) An appropriate time reporting system for all personnel and proper payroll authorizations and vouchers, (iii) Records on all assets capitalized and depreciation on the assets, (iv) Appropriate records of client days, (v) Records on an accrual basis, (vi) A daily midnight bed census by recipient name in a form prescribed by the Department, although use of the prescribed form may be waived by the Department or its designee when a provider demonstrates the ability to maintain a superior system of census information, (vii) Other records as required by the Department, and (viii) A Maryland Medical Assistance log on forms prescribed by the Department; (b) Proper reference to supporting invoices, vouchers, or other forms of original evidence; and (c) A provision for payment by check, although when financial transactions involve numerous small expenditures, an imprest petty cash fund may be established, provided adequate supporting vouchers are maintained; (4) Keep all records available for inspection or audit by the Department or its designee at any reasonable time during normal business hours, with records for each fiscal year's cost report to be retained for 6 years after the filing date of the cost report specified in §A(5) of this regulation; (5) Submit financial and statistical cost reports to the Department or its designee: (a) In a prescribed form; and (b) Within 3 months after the end of the provider's fiscal year unless the: (i) Department grants the provider an extension, or (ii) Provider discontinues participation in the Program; (6) Be considered for an extension as cited in §A(5)(b)(i) of this regulation, which may be granted upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; and (7) If it discontinues participation, submit financial and statistical data to the Department within 45 days after the effective date of termination. B. The Department shall: (1) For cost reports requested in §A(5) of this regulation, which have not been received within the 3-month time period and when an extension has not been granted: (a) Withhold from the provider a maximum of 5 percent of the current interim payment starting at the beginning of the second calendar month after the month in which the report is due, (b) Continue withholding as described in §B(1)(a) of this regulation in any subsequent calendar months, and (c) Retain all withholdings until final cost settlement is completed; (2) When a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, impose one or more sanctions as provided for in Regulation .09 of this chapter; and (3) When a report is not submitted by the last day of the 6th month after the end of the provider's fiscal year, make final cost settlement for that fiscal year at the last final per diem rates for which the Department has verified costs for that facility, if the rates established do not exceed the maximum per diem rates in effect when the facility was last field verified. C. For purposes of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. D. The Program may not make an initial retroactive adjustment when cost reports are received, and tentative settlements may not be made before final settlement. E. When a provider receives notification of final settlement as set forth in Regulation .14A(4) of this chapter and an appeal is filed, undisputed amounts of settlement may not be paid to the appropriate recipients until final findings of the appeal. #### Regulation .13 Interim Rates. *COMAR 10.09.29.13* A. A provider shall have its interim rate updated annually. B. A provider's interim rate shall be adjusted at the beginning of each fiscal year, by applying the Centers for Medicare and Medicaid Services' published federal fiscal year market basket index relating to hospitals excluded from the prospective payment system, subject to the limitations in Regulation .07A of this chapter, to the provider's interim rate in effect on the last day of the preceding fiscal year. C. The rate established in §B of this regulation is in effect until such time as a new rate can be calculated as specified in §§D—F of this regulation. D. The provider shall submit annually, with the cost report described in Regulation .12 of this chapter, schedules detailing projected increases/decreases from the year just ended to the current year. E. The provider shall submit a calculation reflecting the rate being requested for the current year. F. The Department or its designee shall use the submitted cost report, schedules, calculations, and other information as appropriate to calculate an updated interim rate for the current year. G. The rate established in accordance with §F of this regulation shall be implemented for the remainder of the fiscal year with no retroactive supplemental billing or payment for differences in rates. H. Providers may request an interim rate revision: (1) If the revised interim rate exceeds the current rate by 7 percent; and (2) Not more than two times during a fiscal year. I. A request for a revised interim rate shall include, at a minimum: (1) A completed cost report based on a minimum of 3 months of recent actual cost and statistics; (2) An adjusted trial balance covering the cost report period in §I(1) of this regulation; and (3) A calculation reflecting the revised rate being requested. J. A new provider seeking payment for services shall submit to the Department or its designee a projected budgeted cost report and other appropriate information for the period from the beginning of its operations as a provider to the end of its first fiscal year, along with a projected charge rate schedule, for establishment of an initial interim rate by the Department or its designee, subject to the limitations in Regulation .07A of this chapter. #### Regulation .14 Field Verification. *COMAR 10.09.29.14* A. The Department or its designee shall: (1) Conduct a field verification, at least every 3 years, of the reported costs of each facility participating in the Program, if the amount of the facility's reimbursement would justify the expense of a field verification; (2) Desk review the reported costs of the facility in those years when a field verification is not conducted; (3) Notify each provider participating in the Program of the results of the field verification or desk review; and (4) Calculate final settlements by comparing the verified allowable reimbursement to the interim reimbursement. B. Appeal Findings. (1) After the Department receives the findings of an appeal filed under Regulation .10 of this chapter, the Department shall determine the amount that is due either to the Program or to the provider, and notify the provider of that amount. (2) If the provider has accepted the determination made under §B(1) of this regulation, and within 60 days after the provider receives the notification under §B(1) of this regulation, the Program shall pay the amount the Department has determined is due the provider, if any. (3) Subject to the provisions of §B(5) and (6) of this regulation, within 60 days after the provider receives the notification under §B(1) of this regulation, the provider shall pay the amount due the Program, if any. (4) After the expiration of the 60-day period in §B(3) of this regulation, the Department may, in addition to the sanctions provided for in Regulation .09 of this chapter, recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. (5) If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule. (6) The Department shall establish a longer payment schedule if, in the Department's reasonable judgment, failure to grant a longer payment schedule would: (a) Result in financial hardship to the provider; or (b) Have an adverse effect on the quality of patient care furnished by the facility. #### Regulation .15 Change of Ownership. *COMAR 10.09.29.15* A. The current owner of a residential treatment center shall: (1) Notify the Program of the contemplated sale of a facility or controlling interest in it not less than 30 days before the date of the change of ownership; and (2) Before the date of the change of ownership, post an indemnity bond or standby letter of credit, or provide some assurance satisfactory to the Program that the purchaser will assume and be responsible for all financial obligations of the current owner. B. The bond or standby letter of credit under §A(2) of this regulation shall be in the amount of 1 month's Program billings for each unsettled fiscal period outstanding. This amount shall equal the median monthly payment for each unsettled fiscal period. C. The new owner of a residential treatment center shall: (1) Notify the Program of the intent to purchase an existing facility or controlling interest in it, and the desire to enroll in the Program, not less than 30 days before the date of the change of ownership; and (2) Enter into a provider agreement with the Department before being assigned new interim per diem rates. D. Interim Per Diem Rates. (1) For the purpose of establishing interim per diem rates, the new owner in an arm's length change of ownership shall be treated as a new provider under the provisions of Regulation .13J of this chapter. (2) The Department shall establish new interim per diem rates within 90 days after the date of the change of ownership, applicable retroactively to the date of the change of ownership, if the information specified in Regulation .13J of this chapter is submitted to the Department or its designee within 60 days after the date of the change of ownership. (3) Until the new interim per diem rates are established, the new provider may be reimbursed at the interim per diem rates that existed before the date of the change of ownership. (4) Failure by the provider to provide data for interim rate determination within 60 days after the change of ownership may result in temporary withholding of the interim per diem payments. E. Failure to comply with §§A and B of this regulation shall result in all unsettled fiscal periods to be immediately settled at 90 percent of the rates used for the most recently settled fiscal period, and amounts due shall be paid immediately. F. If the provider elects to file an appeal against any action taken under the provisions of §E of this regulation, any amount due to the Department shall be escrowed pending the final outcome of the appeal. G. The Department, in its sole discretion, may waive any of the requirements of this regulation based on exceptional circumstances. ### Chapter 30 — Statewide Evaluation and Planning Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective October 21, 1986 (13:23 Md. R. 2477); emergency status extended at 14:2 Md. R. 125; adopted permanently effective January 27, 1987 (14:2 Md. R. 129) **Administrative History:** Regulation .01B amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129) **Administrative History:** Regulation .02 amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129) **Administrative History:** Regulation .03 amended effective July 12, 1987 (14:14 Md. R. 1571); January 9, 1989 (15:27 Md. R. 3129) **Administrative History:** Regulation .04 amended effective July 12, 1987 (14:14 Md. R. 1571); July 25, 1988 (15:15 Md. R. 1809); January 9, 1989 (15:27 Md. R. 3129) **Administrative History:** Regulation .05 amended effective January 9, 1989 (15:27 Md. R. 3129) **Administrative History:** Regulation .05D amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .06 amended effective July 12, 1987 (14:14 Md. R. 1571); July 25, 1988 (15:15 Md. R. 1809); January 9, 1989 (15:27 Md. R. 3129) **Administrative History:** Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .06C amended as an emergency provision effective December 4, 1990 (17:26 Md. R. 2973); emergency status extended at 18:4 Md. R. 444; amended permanently effective March 18, 1991 (18:5 Md. R. 594) **Administrative History:** Regulation .06C amended as an emergency provision effective July 1, 2001 (28:16 Md. R. 1480); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .06C amended effective December 26, 2011 (38:26 Md. R. 1697) **Administrative History:** Regulation .09 amended effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Chapter revised effective December 11, 2023 (50:24 Md. R. 1041) #### Regulation .01 Purpose. *COMAR 10.09.30.01* The purpose of this chapter is to codify policy regarding comprehensive evaluations performed for the purpose of determining eligibility for services or informing individuals of available services or as required for Geriatric Evaluation Services (GES) or Preadmission Screening and Resident Review (PASRR). #### Regulation .02 Definitions. *COMAR 10.09.30.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Comprehensive evaluation” means the assessment performed by a nurse or social worker, or both, using the tools designated by the Department, of a participant’s medical, social, and functional status by: (a) Direct observation of the participant; (b) Contact, as appropriate, with the participant's representative; and (c) Financial eligibility screening. (2) “Department” means Maryland Department of Health. (3) “Financial eligibility screening” means the determination of whether an individual qualifies financially as a participant. (4) “Geriatric Evaluation Services (GES)” means the assessment that is required to admit an individual to a State facility or Veteran’s Administration hospital. (5) “Nurse” means a person who is licensed as a registered nurse in the jurisdiction in which services are provided. (6) “Nurse practitioner” means a person who is licensed as a nurse practitioner in the jurisdiction in which services are provided. (7) “Participant” means a Medicaid recipient or an individual who would be able to establish financial eligibility under the Program within 6 months of admission to a nursing facility, whose needs may not be adequately met in an episodic ambulatory care setting, and who may require continuing institutional or community based long-term care services. (8) “Plan of care” means the written long term care plan composed of a comprehensive evaluation of the participant’s health status including: (a) Pertinent diagnoses; (b) Psychosocial status; (c) Functional status; and (d) Type of services recommended. (9) “Preadmission Screening and Resident Review (PASRR)” means the screening or reviewing of all individuals with mental illness or intellectual disability who apply to or reside in Medicaid-certified nursing facilities. (10) “Program” has the same meaning as defined in COMAR 10.09.36. (11) “Provider” means a local health department, or when necessary, a contracted agency: (a) Providing the comprehensive evaluation through an appropriate agreement with the Department and identified as a Program provider by the issuance of an individual account number; (b) Employing nurses and social workers to provide the comprehensive evaluation; and (c) Demonstrating experience in providing assessment and evaluation services and in developing plans of care. (12) “Provider agreement” means a contract between the Department and the provider of STEPS specifying the: (a) Services to be performed; (b) Methods of operation; and (c) Financial and legal requirements which shall be in force before Program participation. (13) “Psychiatrist” means a person who is licensed as a psychiatrist in the jurisdiction in which services are provided. (14) “Psychologist” means a person who is licensed as a psychologist in the jurisdiction in which services are provided. (15) “Social worker” means a person who is licensed as a social worker in the jurisdiction in which services are provided. #### Regulation .03 Licensing Requirements. *COMAR 10.09.30.03* The following health professionals providing services under this regulation shall be licensed to practice in the jurisdiction in which services are rendered: (1) Nurses; (2) Nurse practitioners; (3) Psychiatrists; (4) Psychologists; and (5) Social workers. #### Regulation .04 Conditions for Participation. *COMAR 10.09.30.04* Specific requirements for participation in the Program are that providers shall: A. Ensure that all individuals performing services under Regulation .05 of this chapter meet the licensure requirements as provided in Regulation .03 of this chapter; B. Have existing policies and procedures concerning the completion of comprehensive evaluations, and expedition of those evaluations when necessary, that the provider has agreed to perform; C. Develop, as appropriate, agreements in order to facilitate access to services and coordinate with local public agencies and other providers; D. If approved as a provider of comprehensive evaluations, inform participants of the results of the comprehensive evaluation and of available services; and E. Ensure completion, at least every other year, of training on the tools designated by the Department for the purposes of the comprehensive evaluation, by all nurses and social workers providing services under this chapter. #### Regulation .05 Covered Services. *COMAR 10.09.30.05* A. The Program reimburses for completed comprehensive evaluations, which include assessment by a nurse, social worker, or both. B. The comprehensive evaluation or designated form is to be completed within the following time frames: (1) 3 business days for all Geriatric Evaluation Services (GES) and Preadmission Screening and Resident Review (PASRR) for individuals transferring from a hospital to a nursing facility; (2) 5 business days for all other PASRR; and (3) 15 calendar days for all other purposes. C. The comprehensive evaluation shall be completed in-person. D. The Department will reimburse for the services listed in §A of this regulation when they are: (1) Rendered to participants as defined in Regulation .02 of this chapter; (2) Completed within the time frame specified in §B of this regulation, unless the Department is notified, in writing, of circumstances that prevent completion within the specified time frame and a temporary, alternative schedule has been approved by the Department; (3) Adequately performed as reflected on the completed form specified by the Department and submitted to the Program as a condition for payment; and (4) Rendered by a provider approved to perform comprehensive evaluations. #### Regulation .06 Limitations. *COMAR 10.09.30.06* A. The comprehensive evaluation is advisory in nature and is designed to assist individuals in identifying and using appropriate long term care services. B. A restriction may not be placed on the qualified recipient’s option to receive the comprehensive evaluation. C. The comprehensive evaluation does not restrict or otherwise affect: (1) Eligibility for Title XIX benefits or other available benefits or programs; (2) The freedom of a recipient to select from all available services, including nursing home care, for which the individual is found to be eligible; or (3) The participant's free choice of qualified providers. #### Regulation .07 Payment Procedures. *COMAR 10.09.30.07* A. Request for Payment. (1) Requests for payment of services rendered shall be submitted according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider. (2) Requests for payment shall be submitted on the form specified by the Department. B. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. C. Effective July 1, 2022, payments for comprehensive evaluations shall be made in accordance with the fee schedule below: #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.30.08* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.30.09* Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.30.10* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.30.11* Interpretive regulatory requirements are as set forth in COMAR 10.09.36.10. ### Chapter 31 — Emergency Service Transporters **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-114.1, Annotated Code of Maryland **Administrative History:** Effective date: June 14, 1999 (26:12 Md. R. 925) **Administrative History:** Regulation .01B amended effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .03B, C amended effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .03D adopted effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .05 amended effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .06 amended effective May 1, 2023 (50:8 Md. R. 337) #### Regulation .01 Definitions. *COMAR 10.09.31.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” has the meaning stated in COMAR 10.09.36. (2) “Emergency medical services (EMS) provider " has the meaning stated in Education Article, §13–516, Annotated Code of Maryland. (3) “Emergency service transporter” means a public entity or volunteer fire, rescue, or emergency medical service that provides emergency medical transportation services. (4) “EMS Board” means the State Emergency Medical Services Board established by Education Article, §13-503, Annotated Code of Maryland. (5) “Facility” means a hospital or nursing facility including an intermediate care facility, skilled nursing facility, comprehensive care facility, or extended care facility. (6) “Free-standing urgent care center” means a location, distinct from a hospital emergency room, a physician's office, or a free-standing clinic, whose purpose is to diagnose and treat illness or injury for unscheduled, ambulatory patients seeking immediate medical attention. (7) “Mobile integrated health” means a community-based preventive, primary, chronic, pre-admission, or post-admission health care service provided by an emergency medical services provider to a participant. (8) “Participant” has the meaning stated in COMAR 10.09.36. (9) “Program” has the meaning stated in COMAR 10.09.36. (10) “Provider” has the meaning stated in COMAR 10.09.36. #### Regulation .02 Licensing Requirements. *COMAR 10.09.31.02* A provider shall meet all licensing requirements: A. Set forth in COMAR 10.09.36; and B. In the jurisdiction where the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.31.03* To participate in the Program, the provider shall: A. Comply with the conditions for participation set forth in COMAR 10.09.36; B. Certify that all third-party payers are routinely billed for services; C. Retain all documentation, including but not limited to run sheets, for 6 years; and D. When delivering mobile integrated health, render services in accordance with the MIH services medical protocols adopted by the EMS Board. #### Regulation .04 Covered Services. *COMAR 10.09.31.04* A. Emergency Medical Transportation Services. The Program covers the following services when provided by an enrolled emergency service transporter to an eligible participant in response to a 911 call: (1) Medical services delivered at the scene of a 911 response consistent with EMS Board protocols, with or without subsequent transportation; (2) Medical services provided while transporting the participant to a facility, free-standing urgent care center, or other Department-approved destination; and (3) Transportation to a facility, free-standing urgent care center, or other Department-approved destination. B. Mobile Integrated Health Services. The Program covers the following medically necessary mobile integrated health services when delivered by an EMS provider or any team member in the participant’s home or another community-based setting permitted by the EMS Board’s medical protocols: (1) Health assessments; (2) Remote medical diagnostics; (3) Chronic disease monitoring and education; (4) Medication compliance; (5) Immunizations and vaccinations; (6) Laboratory specimen collection; (7) Hospital discharge follow-up care; and (8) Minor medical procedures. #### Regulation .05 Limitations. *COMAR 10.09.31.05* Under this chapter, the Program does not cover: A. Services not rendered in response to a 911 call unless delivered as part of a mobile integrated health visit; B. Services performed or billed by an emergency services transporter that is not enrolled in the Program; C. Services rendered by an emergency services transporter in response to a 911 call when the participant refuses medical services and transport of the participant does not occur; D. Services rendered to anyone other than an eligible participant; E. Services for which proper documentation, including but not limited to run sheets, cannot be provided on request of the Department or its designee; F. Services not indicated by the medical protocols adopted by the EMS Board; G. Mobile integrated health services delivered to participants younger than 18 years old; and H. Services delivered in any setting other than the eligible participant’s home or any community-based site permitted under the medical protocols adopted by the EMS Board. #### Regulation .06 Payment Procedures. *COMAR 10.09.31.06* A. Payment procedures for this chapter are set forth in COMAR 10.09.36. B. Emergency Medical Transportation Services Reimbursement. (1) Payment for covered services provided in response to each 911 call incident is the lesser of: (a) The amount billed; or (b) Effective July 1, 2022, $150. (2) Effective January 1, 2023, payment for covered services provided in response to each 911 call incident that does not result in a transport is the lesser of: (a) The amount billed; or (b) $150. C. Mobile Integrated Health Reimbursement. (1) Payment for a mobile integrated health visit is the lesser of: (a) The amount billed; or (b) Effective January 1, 2023, $150. (2) The provider shall bill one mobile integrated health service, regardless of the number of clinical services rendered to a participant during the visit. D. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.31.07* Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.31.08* Cause for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36. #### Regulation .09 Appeal Procedures. *COMAR 10.09.31.09* Appeal procedures under this chapter are set forth in COMAR 10.09.36. ### Chapter 32 — Targeted Case Management for HIV-Infected Individuals **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: July 11, 1988 (15:14 Md. R. 1655) **Administrative History:** Regulations .01—.06 amended as an emergency provision effective December 26, 1988 (15:27 Md. R. 3123); adopted permanently effective April 25, 1989 (16:7 Md. R. 811) **Administrative History:** Regulations .01—.06 amended as an emergency provision effective August 28, 1990 (17:19 Md. R. 2318); emergency status expired November 11, 1990; amended permanently effective November 26, 1990 (17:23 Md. R. 2732) **Administrative History:** Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Chapter revised effective September 30, 1991 (18:19 Md. R. 2100) **Administrative History:** Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); April 2, 2012 (39:6 Md. R. 408) **Administrative History:** Regulation .03 amended effective April 2, 2012 (39:6 Md. R. 408) **Administrative History:** Regulation .04 amended effective August 27, 2007 (34:17 Md. R. 1507); April 2, 2012 (39:6 Md. R. 408) **Administrative History:** Regulation .05D, E amended effective April 2, 2012 (39:6 Md. R. 408) **Administrative History:** Regulation .06A, C amended effective April 2, 2012 (39:6 Md. R. 408) #### Regulation .01 Definitions. *COMAR 10.09.32.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Case management” means services which will assist participants in gaining access to the full range of Medical Assistance services, as well as to any additional needed medical, social, housing, financial, counseling, and other support services. (2) “Case manager” means a physician, nurse, or social worker (refer to Regulation .02 of this chapter) employed by the HIV ongoing case management provider and chosen by the participant or the participant’s legally authorized representative. (3) “Department” means Department as defined in COMAR 10.09.36.01. (4) “Entity” means a facility, agency, organization, department, office, corporation, partnership, group or individual. (5) “HIV diagnostic evaluation services” means a bio-psychosocial assessment of a participant and development or revision of an individualized plan of care by a multidisciplinary team convened by an approved HIV diagnostic evaluation services provider. (6) “HIV diagnostic evaluation services provider” means an entity approved by the Department as a provider of HIV diagnostic evaluation services, as defined in Regulation .03 of this chapter. (7) “HIV-infected individual” means a person determined as positive for human immunodeficiency virus (HIV) infection by the enzyme-linked immunosorbent assay (ELISA) and confirmed by the Western Blot, or another generally accepted diagnostic testing algorithm for HIV infection. (8) “HIV ongoing case management” means the activities involved in developing, revising, implementing, and monitoring the plan of care, as performed by a case manager through an approved HIV ongoing case management provider. (9) “HIV ongoing case management provider” means an entity, as defined in Regulation .03 of this chapter, approved by the Department as a provider of ongoing case management services to participants. (10) “HIV-targeted case management” means the provision of HIV diagnostic evaluation services and HIV ongoing case management. (11) “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (12) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (13) “Multidisciplinary team” means the members convened by the HIV diagnostic evaluation services provider to perform a bio-psychosocial assessment of the participant and develop or revise an individualized plan of care. (14) “Nurse” means a person who is licensed as a registered nurse in the jurisdiction in which services are provided. (15) “Ongoing case management” means the activities involved in developing, revising, implementing, and monitoring the plan of care, as performed by a case manager through an approved HIV ongoing case management provider. (16) “Participant” means a recipient who: (a) Has been diagnosed as HIV-infected or is a child less than 2 years old born to a woman diagnosed as HIV-infected; (b) Elects, or has a legally authorized representative elect in the recipient's behalf, to receive the services available under these regulations; and (c) Is not receiving the same case management services under the Social Security Act, §1915(b), 1915(c), or 1915(g). (17) “Physician” means a doctor of medicine or osteopathy who is licensed to practice medicine in the jurisdiction in which services are rendered. (18) “Plan of Care” means a goal-directed treatment plan developed and revised by the HIV diagnostic evaluation service provider’s multidisciplinary team that is based on the bio-psychosocial assessment. (19) “Program” means the Program as defined in COMAR 10.09.36.01. (20) “Provider” means the HIV diagnostic evaluation services provider or HIV ongoing case management provider, which offers covered case management services to participants through a provider agreement signed with the Department and which is identified as a Program provider by issuance of an individual account number. (21) “Provider agreement” means a contract between the Department and the provider. (22) “Recipient” means recipient as defined in COMAR 10.09.36.01. (23) “Social worker” means a person who is in compliance with the social work licensing requirements of the jurisdiction in which services are provided. #### Regulation .02 Licensing Requirements. *COMAR 10.09.32.02* A. Registered nurses participating in targeted case management for HIV-infected individuals shall be licensed pursuant to Health Occupations Article, Title 7, Annotated Code of Maryland, or pursuant to comparable licensing requirements of the jurisdiction in which services are rendered. B. Social workers participating in targeted case management for HIV-infected individuals shall be licensed pursuant to Health Occupations Article, Title 18, Annotated Code of Maryland. C. Physicians participating in targeted case management for HIV-infected individuals shall be licensed to practice medicine in the jurisdiction in which services are rendered. #### Regulation .03 Conditions for Participation. *COMAR 10.09.32.03* A. General requirements for participation in the Medical Assistance Program are that providers shall meet all the conditions for participation as set forth in COMAR 10.09.36.03. B. Specific requirements for participation in the Program as a provider of services covered under this chapter are that the provider shall maintain a record on each participant which meets the Program’s requirements and which includes: (1) Verification of the participant’s HIV-infected status; (2) Verification of the participant’s eligibility for services; (3) A signed consent form by the participant to participate in HIV ongoing case management; (4) The completed bio-psychosocial assessment; (5) The completed plan of care signed by all members of the multidisciplinary team; (6) Documentation for each contact made by the case manager including: (a) Date and subject of contact; (b) Person contacted; (c) Person making the contact; (d) Nature, extent, and unit or units of service provided; and (e) Place of service; and (7) A signed case closure form when HIV ongoing case management services are ended. C. Specific requirements for participation in the Program as an HIV diagnostic evaluation services provider are that the provider shall: (1) Be a physician or a health or social services entity which employs or has a written agreement with physicians, nurses, or social workers for provision of its diagnostic evaluation services who are experienced or trained in the provision of services to HIV-infected individuals; (2) Have a written plan for the implementation of HIV diagnostic evaluation services; (3) Be available to participants at least 8 hours a day, 5 days a week, except on State holidays; (4) Have existing policies and procedures concerning the performance of HIV diagnostic evaluation services; (5) Develop procedures to expedite bio-psychosocial assessments when necessary; (6) Have access to specialty physicians experienced and trained in the provision of services to HIV-infected individuals for consultation, as necessary, concerning a participant’s medical assessment and the medical services recommended in the plan of care. (7) Present a qualified recipient with the option of receiving HIV diagnostic evaluation services and HIV ongoing case management services. If the recipient elects to receive HIV ongoing case management, the provider shall ask the recipient to select from a list of qualified HIV ongoing case management providers. (8) Establish a written agreement with any entity approved as an HIV ongoing case management provider which a participant selects as his or her case manager and agrees to allow the case manager chosen by the participant to: (a) Participate as a member of the multidisciplinary team; (b) Assist with performance of the bio-psychosocial assessment; (c) Assist with the development and revision of the plan of care; and (d) Monitor the participant’s need for a revised bio-psychosocial assessment. (9) Convene a multidisciplinary team for each participant, to perform the bio-psychosocial assessment and develop or revise an individualized plan of care. The team shall be composed of: (a) The participant; (b) The participant’s legally authorized representative or representatives; (c) Any additional representatives chosen by the participant, if desired; (d) A representative from the HIV diagnostic evaluation services provider which may include any of the following as necessary and appropriate: (i) The participant’s primary care physician; (ii) Nurse; (iii) Current service provider or providers; (iv) Specialty physician; or (v) Social worker; and (e) The participant’s case manager. If employed by the HIV diagnostic evaluation services provider, the case manager may also act as the representative from the provider. (10) Inform the participant or the participant’s legally authorized representative or representatives of: (a) Recommendations for the plan of care in the bio-psychosocial assessment; and (b) Availability of needed services. (11) Have the capacity to conduct, at minimum, an annual bio-psychosocial assessment of the participant, unless an earlier assessment is recommended by the case manager or multidisciplinary team. D. Specific requirements for participation in the Program as an HIV ongoing case management provider are that the provider shall: (1) Be a health or social services entity employing registered nurses, social workers, or physicians, who are trained and have at least 1 year experience in the provision of services as a case manager. Experience may have been acquired as volunteer work or field placement; (2) Have a written agreement: (a) With any entity approved as an HIV diagnostic evaluation services provider from whom the ongoing case management provider is accepting referrals, and (b) Which permits the case manager to participate as a member of the multidisciplinary team, to have access to the plan of care, and to request a bio-psychosocial assessment and plan of care revision as necessary; (3) Have a written plan for the implementation of HIV ongoing case management services; (4) Have existing policies and procedures concerning the performance of HIV ongoing case management; (5) Provide HIV ongoing case management services to participants who: (a) Are assessed by an HIV diagnostic evaluation services provider; (b) Are recommended for HIV ongoing case management services in the plan of care; and (c) Elect to receive ongoing case management services; (6) Be available to participants at least 8 hours a day, 5 days a week, except on State holidays; (7) Have established alternatives for managing participants’ medical and social crises during off-hours that will be specified in participants’ individualized plans of care; (8) Have the capacity to meet with the participant face-to-face; (9) Be knowledgeable of the eligibility requirements and application procedures of applicable federal, State, and local government assistance programs; and (10) Maintain a current listing of medical, social, housing assistance, mental health, financial assistance, counseling, and other support services available to HIV-infected individuals. #### Regulation .04 Covered Services. *COMAR 10.09.32.04* The Program covers the following services when they have been documented as medically necessary: A. HIV Diagnostic Evaluation Services. (1) These services shall include, as a unit of service, performance of a bio-psychosocial assessment and development or revision of a recommended plan of care, as well as all other necessary covered services described in §A(2) of this regulation. (2) A bio-psychosocial assessment shall be completed within 6 weeks of the participant’s referral for case management services. The assessment shall be performed by the HIV diagnostic evaluation services provider representative on the multidisciplinary team and include: (a) A review of relevant medical and other records, with the participant’s or legal representative’s written consent; (b) A consult with the participant’s attending physician and current providers of medical, social, or other support services, as appropriate; (c) A face-to-face assessment of the participant, preferably at the participant’s residence, to determine: (i) Medical, psychiatric, and substance abuse history, including current medications; (ii) Nutritional status; (iii) Emotional and behavioral status; (iv) Health care coverage; (v) Living situation; (vi) Personal support systems; (vii) Employment and income status; (viii) Health education; (ix) Social support; and (x) Any additional service needs; (d) A consult, as appropriate, with the participant or the participant’s legally authorized representative or representatives; and (e) All areas listed on the Department’s approved sample bio-psychosocial assessment form. (3) Documentation of the results of the assessment shall be kept in the participant’s record. (4) The multidisciplinary team will develop a written, individualized plan of care which reflects both the needed and available services being recommended for delivery. (5) The plan of care shall: (a) Be participant-centered and goal-oriented; (b) Be developed and written in collaboration with the participant and other members of the multidisciplinary team; (c) Incorporate findings from the bio-psychosocial assessment; (d) Incorporate findings and recommendations from the multidisciplinary team; (e) Establish a plan for after-hours crises, including medical and social crises, and other emergency situations; (f) Document the proposed frequency of contact with a minimum of 1 face-to-face meeting every 6 months; and (g) Address all areas listed on the Department’s approved sample plan of care form. B. HIV Ongoing Case Management Services. (1) The case manager shall assist with the bio-psychosocial assessment and with development or revision of the plan of care by: (a) Conducting a face-to-face assessment of the participant’s psychosocial status and health care needs and briefing the multidisciplinary team on the findings; (b) Participating in the development or revision of an individualized plan of care for the participant; (c) Encouraging the participant’s and representative’s participation in the multidisciplinary team process; and (d) Linking the participant with any services needed on an emergency basis before the plan of care or revision is finalized. (2) The HIV ongoing case management provider may be reimbursed for the case manager’s participation as a member of the multidisciplinary team, convened to review the participant’s case by the HIV diagnostic evaluation services provider. (3) The case manager: (a) Participates as a member of the multidisciplinary team convened by the HIV diagnostic evaluation services provider; (b) Assumes responsibility for providing case management services to the participant; (c) Acts as a point of contact for the case; and (d) Implements and monitors the plan of care recommended by the HIV diagnostic evaluation services provider’s multidisciplinary team and approved by the participant. (4) HIV ongoing case management services shall be provided to participants who: (a) Are recommended in the plan of care as needing case management; and (b) Who elect to receive case management services. (5) The plan of care shall be implemented as follows: (a) The case manager shall make initial contact with the participant to assure that medical and support referrals were completed and followed-up on; (b) The case manager shall maintain regular contact that will occur at intervals agreed on by the participant and case manager in the plan of care; (c) The case manager or HIV ongoing case management provider, when necessary, shall respond to participant-initiated non-emergency contact within 2 working days; (d) The participant or the participant’s representative or representatives shall be offered a copy of the plan of care; (e) The case manager shall document every direct and indirect contact, including assessing the progress of implementation of the plan of care in the participant’s record; (f) The case manager shall assist the participant with each action plan to reach the goals outlined in the plan of care; (g) The case manager shall advise the participant about available services and service providers, by making referrals to and arrangements with service providers selected by the participant, and by assisting the participant in gaining access to services for which the participant is eligible and which the participant chooses, to include: (i) The full range of Medical Assistance services; and (ii) Other available support services such as medical, social, housing, financial, and counseling; (h) The case manager shall provide the participant with any necessary counseling concerning: (i) Government entitlement programs; (ii) Health programs; (iii) Social programs; (iv) Educational programs; (v) Psychological programs; (vi) Financial programs; (vii) Housing programs; and (viii) Other resources; (i) The case manager shall follow up with referral sources; and (j) The case manager shall examine the actual service delivery against the plan of care. (6) The case manager shall monitor and evaluate the participant’s plan of care as follows: (a) Review and check the status of each activity outlined in the plan of care; (b) Modify the action plan or goals to accommodate the participant’s changing needs or changes in service availability; (c) Monitor the plan of care at regular intervals that have been predetermined at the time of the plan of care or more often depending on participant need; (d) Evaluate the plan of care, in collaboration with the participant, at least every 6 months, with input from any members of a multidisciplinary team who have been involved with the participant’s care. (7) The case manager shall document the following in the participant’s record regarding case closure: (a) Participant notification, including date of closure, reason, and explanation of closure; (b) Participant’s notification of right to re-enter services at a later time; (c) Documentation of coordination and referral to a new provider if desired by the participant; and (d) Documentation of a participant’s non-response to case manager attempts to reach the participant over a 6-month period of time with at least 3 attempts to contact the participant. #### Regulation .05 Limitations. *COMAR 10.09.32.05* A. HIV-targeted case management shall be advisory in nature. B. A restriction may not be placed on qualified recipients' option to receive HIV case management services. C. HIV-targeted case management does not restrict or otherwise affect: (1) Eligibility for Title XIX benefits or other available benefits or programs; (2) The freedom of a recipient to select from all available services for which the individual is found to be eligible; or (3) The participant's free choice of qualified providers. D. HIV-targeted case management may not be: (1) Provided as an integral and inseparable part of another covered Program service; (2) Provided as an administrative function; (3) Rendered in connection with the implementation of the Social Security Act, §1915(b) or 1915(c); or (4) Part of institutional discharge planning. E. Reimbursement may not be made for HIV-targeted case management services if the participant is: (1) Eligible to receive services under the Maryland Medicaid Managed Care Program, as defined in COMAR 10.09.62; or (2) Receiving comparable case management services under: (a) The Rare and Expensive Case Management Program, as defined in COMAR 10.09.69; or (b) Under another Program authority. F. A participant's case manager may not be a direct services provider for the participant. #### Regulation .06 Payment Procedures. *COMAR 10.09.32.06* A. Request for Payment. (1) Requests for payment of HIV-targeted case management services rendered shall be submitted by an approved provider according to procedures as set forth in COMAR 10.09.36.04. (2) Requests for payment shall be submitted on the invoice form specified by the Department. The completed form shall indicate the: (a) Date or dates of service; (b) Participant's name and Medical Assistance number; (c) Provider's name, identification number, and location; and (d) Nature, procedure code or codes, and unit or units of covered service provided. (3) Providers shall bill the Program for the appropriate fee specified in §C of this regulation. B. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. C. Payments shall be made: (1) Only to 1 provider for a specific type of HIV-targeted case management services rendered to a participant during a specified time period; (2) To an HIV ongoing case management provider that shall be reimbursed in 15-minute increments, which is equal to 1 unit of service. Reimbursement for HIV ongoing case management may not exceed 96 units of service per year following the date of service for the HIV diagnostic evaluation services; and (3) To a provider of HIV-targeted case management services that may not exceed the following fee schedule: (a) For the completion of a bio-psychosocial assessment and development or revision of the plan of care performed by an HIV diagnostic evaluation services provider — $200; (b) For the participation by the case manager in the completion of the bio-psychosocial assessment and development or revision of the plan of care, as specified in Regulation .04B of this chapter up to 6 units of service at a rate of $17.86 per unit of service (c) For HIV ongoing case management, up to 96 units of service, at a rate of $17.86 per unit of service, may be reimbursed per year following completion of the bio-psychosocial assessment and development or revision of the plan of care by a qualified provider of HIV diagnostic evaluation services. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.32.07* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.32.08* Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.32.09* Appeal procedures shall be as set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.32.10* State regulations shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 33 — Health Homes **Authority:** Health-General Article, §§2-104(b), 7.5-204, 7.5-205(d), 7.5-402, 8-204(c), 15-103, and 15-105(b), Annotated Code of Maryland **Administrative History:** Effective date: September 30, 2013 (40:19 Md. R. 1544) **Administrative History:** Regulation .01B amended effective July 7, 2014 (41:13 Md. R. 752); November 13, 2023 (50:22 Md. R. 973); May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04 amended effective November 24, 2014 (41:23 Md. R. 1372) **Administrative History:** Regulation .04P amended effective May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .06B amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .06C, H amended effective May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .07 amended effective May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .07A amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .08C amended effective April 4, 2022 (49:7 Md. R. 465), May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .08D amended effective May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .09 amended effective April 4, 2022 (49:7 Md. R. 465) **Administrative History:** Regulation .09B amended effective May 11, 2026 (53:9 Md. R. 412) **Administrative History:** Regulation .09C amended effective October 24, 2016 (43:21 Md. R. 1166); January 1, 2018 (44:26 Md. R. 1215); December 30, 2019 (46:26 Md. R. 1164); November 13, 2023 (50:22 Md. R. 973); September 16, 2024 (51:18 Md. R. 808); November 10, 2025 (52:22 Md. R. 1095) #### Regulation .01 Definitions. *COMAR 10.09.33.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative service organization (ASO)” has the meaning stated in COMAR 10.09.59.01. (2) “ASO system” means the electronic system available to providers which the ASO utilizes to manage Maryland’s Public Behavioral Health System as defined in COMAR 10.09.59.01. (3) “Care management tool” means a system that helps accomplish administrative tasks of the health home, including maintaining a list of health home participants and scheduling and tracking participants clinical appointments. (4) “Care plan” means a written plan of action that is developed and modified to address a patient's specific behavioral, somatic, and social service needs, which is maintained in the individual's medical record and satisfies the following conditions: (a) Meets the requirements of COMAR 10.47.01.04C; or (b) Meets the requirements of COMAR 10.21.21.06C. (5) “Caregiver” means a family member, guardian, or other individual who is not paid to provide care to the participant and who helps the participant achieve and maintain wellness. (6) “Chesapeake Regional Information System for Our Patients (CRISP) means the electronic notification system health home providers are required to use in order to access participant hospital encounter data. (7) “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C §1396 et seq. (8) “Full-time equivalent (FTE)” means an employee who works 40 hours per week. (9) “Health home” means a provider designated to offer enhanced care coordination and management services to individuals affected by, or at risk for, chronic conditions, operating under the conditions of this chapter. (10) “Health Information Technology” means electronic systems equipped for the exchange of health data to link services, facilitate communication between health team members and individuals and family caregivers, and enable quality reporting and the review of health outcomes. (11) “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. (12) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (13) “Mental health case management” means services covered under COMAR 10.09.45 and COMAR 10.09.90 which assist participants in gaining access to the full range of mental health services, and necessary medical, social, financial assistance, counseling, educational, housing, and other support services. (14) “Minor” means an individual who is younger than 18 years old. (15) “Mobile treatment services (MTS) program” means a program approved under COMAR 10.63.03.04. (16) “Opioid treatment program (OTP)”, formerly referred to as opioid maintenance therapy (OMT) programs, means a program approved to provide opioid maintenance therapy under COMAR 10.63.03.19. (17) “Participant” means an individual enrolled in a health home funded by the Medical Assistance Program. (18) “Provider” means an individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide health services. (19) “Psychiatric rehabilitation program (PRP)” means a program approved under COMAR 10.63.03.09 for adults, COMAR 10.63.03.10 for minors, or both. #### Regulation .02 Licensing Requirements. *COMAR 10.09.33.02* A. A PRP serving adults and participating as a health home shall be approved pursuant to COMAR 10.63.03.09. B. A PRP serving minors and participating as a health home shall be approved pursuant to COMAR 10.63.03.10. C. An MTS program participating as a health home shall be approved pursuant to COMAR10.63.03.04. D. An OTP participating as a health home shall be approved to provide opioid maintenance therapy pursuant to COMAR 10.63.03.19. #### Regulation .03 Participant Eligibility. *COMAR 10.09.33.03* A. An individual is eligible for health home services if the individual: (1) Is a recipient of Maryland Medical Assistance; and (2) Meets the following criteria: (a) Receives outpatient mental health rehabilitation or treatment services with a PRP or MTS program for a serious and persistent mental illness or serious emotional disturbance, and is not currently receiving: (i) 1915(i) waiver services; or (ii) Mental health case management; or (b) Receives treatment with an OTP for an opioid substance use disorder and is at risk for additional chronic conditions based on: (i) Current alcohol use, tobacco use, or other non-opioid use; or (ii) A history of alcohol, tobacco, or other non-opioid substance dependence. B. A health home participant that is no longer receiving services from their PRP, MTS program, or OTP provider may continue to receive health home services for up to 6 months for the purposes of reengagement or transition to another level of care. #### Regulation .04 Conditions for Health Home Provider Participation. *COMAR 10.09.33.04* To be eligible as a health home, a provider shall: A. Meet the conditions for provider participation in the Medical Assistance Program, as set forth in COMAR 10.09.36.03; B. Meet the approval requirements set forth in Regulation .02 of this chapter; C. Be accredited by, or demonstrate evidence of having started the accreditation process from, an approved accrediting body as a health home; D. For PRP and MTS health homes serving minors, demonstrate a minimum of 3 years of experience serving minors, which may be achieved as an independent practice or as a member of a broader agency, with exceptions designated by the Department; E. At the time of enrollment as a health home, be registered or be able to provide documentation of starting the process of registration with CRISP in order to receive hospital encounter alerts; F. At the time of enrollment as a health home, be registered or be able to provide documentation of starting the process of registration with one of the following organizations in order to receive access to real-time pharmacy data for participants: (1) CRISP; or (2) The State’s ASO; G. At the time of enrollment as a health home, have an internal protocol for reviewing and responding to hospital encounter alerts and pharmacy use data; H. Directly provide, or subcontract for the provision of, health home services to all participants; I. Maintain an electronic database with the ability to, at minimum: (1) Maintain an up-to-date list of all health home participants and their contact information; and (2) Record and review clinical appointments; J. Maintain a file for each participant that includes: (1) A form signed by the participant consenting to participate in the health home, including the program’s data-sharing elements; (2) An initial assessment of the participant’s health and social services needs, as described in Regulation .06B(1)(a) of this chapter; and (3) A care plan, updated every 6 months, which may be combined with the existing MTS, PRP, or OTP care plan, and includes, at a minimum: (a) The participant’s health home goals; (b) Time frames for meeting the health home goals; (c) Proposed interventions for meeting the health home goals; (d) Relevant community networks and supports; (e) Optimal clinical outcomes for the participant; and (f) Signatures of: (i) The participant or the participant’s parent or guardian; and (ii) The nurse care manager to whom the participant has been assigned in the health home; K. Safeguard the confidentiality of the participants’ records in accordance with State and federal laws and regulations; L. Provide on-call and crisis intervention services by telephone 24 hours a day, 7 days a week to participants and, as appropriate, their caregivers, or if the participant is a minor, the minor’s parent or guardian; M. Be responsible for meeting all health home service requirements, including services performed by a business or individual subcontracted to provide such services; N. Convene health home staff meetings every 6 months, at minimum, to plan and implement goals and objectives of functioning as a health home; O. Collaborate with MCOs and the ASO to improve participant outcomes; and P. Agree to participate in federal and State-required evaluation activities, including: (1) Using the ASO system to: (a) Submit encounters documenting participants’ services at least monthly; (b) Generate monthly reports documenting: (i) Health home service delivery; and (ii) Participants’ health and social outcomes; and (c) Update participant diagnoses and outcomes every 6 months; and (2) Completing and submitting to the Department a program assessment every 6 months to demonstrate that: (a) All staffing and other regulatory requirements are being met; and (b) A quality improvement plan is being implemented. #### Regulation .05 Health Home Provider Staff. *COMAR 10.09.33.05* A. Health Home Staffing Requirements. (1) Health Home Care Manager. (a) At minimum, the health home shall maintain health home care manager staff at a ratio of .5 FTE per 125 participants. (b) Up to a staffing level of 1 FTE, the health home care manager shall be a: (i) Nurse practitioner meeting the conditions of COMAR 10.27.07; or (ii) Registered nurse licensed pursuant to COMAR 10.27.01 and meeting the conditions of COMAR 10.27.09. (c) A health home employing more than 1 FTE health home care manager may employ a physician’s assistant licensed pursuant to COMAR 10.32.03.04 to fulfill the additional care manager roles. (2) Health Home Director. (a) At minimum, the health home shall maintain a health home director at a ratio of .5 FTE per 125 health home participants. (b) A health home requiring a health home director and health home care manager of .5 FTE each may employ 1 FTE individual to serve in both roles, provided that individual meets the requirements for both positions. (c) A health home requiring more than .5 FTE health home director, may choose to designate a lead health home director and fulfill the additional FTE requirement with key management staff who meet the requirements of §A(2)(d)(i) or (ii) of this regulation. (d) The health home director shall: (i) Possess a Bachelor’s degree from an accredited university and 2 years experience in health administration; (ii) Possess a Master’s degree from an accredited university in a related field; (iii) Be licensed as a Registered Nurse with the Maryland Board of Nursing; or (iv) Be licensed as a Physician or be licensed as a Nurse Practitioner. (3) Physician or Nurse Practitioner Consultant. (a) At minimum, the health home shall maintain physician or nurse practitioner services at a ratio of one and one half (1.5) hours per health home participant per 12-month period. (b) The physician shall meet the conditions of COMAR 10.32.01. (c) The nurse practitioner shall meet the conditions of COMAR 10.27.07. (4) Administrative Support Staff. (a) The health home shall maintain administrative support at a level sufficient to meet the service provision and reporting requirements of the health home. (b) Administrative support for the health home may be one or a combination of the following: (i) Administrative support staff; or (ii) An electronic care management tool that addresses the administrative health home tasks. B. A health home with fewer than 125 participants may form a consortium to share health home staff and costs, contingent upon geographic proximity and Department approval of a plan detailing the proposed collaboration. C. Should staffing levels drop below the levels required by this regulation for more than 60 days, the health home shall: (1) Report this to the Department; and (2) Demonstrate that steps have been taken to reach the required staffing levels. D. Health home staff members shall be dedicated to health home duties at a level of .5 FTE minimally, and staffing requirements may not be divided among staff at levels below .5 FTE each. E. To begin offering health home services, a provider shall have in place a health home director and health home care manager at levels of .5 FTE each, minimally. Additional staff required to meet the staffing levels specified in §§A—D of this regulation shall be hired within 30 days of beginning service provision. #### Regulation .06 Covered Services. *COMAR 10.09.33.06* A. The Department covers the services in §§B—G of this regulation when these services have been documented, pursuant to the requirements in this chapter, as necessary. B. Comprehensive Care Management. The health home shall collaborate to provide comprehensive care management services including: (1) An initial assessment performed prior to the patient's enrollment, which includes: (a) A comprehensive assessment of the participant's physical health, mental health, chemical dependency, and social service needs, signed off on by a physician or nurse practitioner, if no such assessment has been performed in the preceding 6-month period; and (b) Requesting records from the participant's primary care physician and other providers; (2) Development of a care plan within 30 days following enrollment, in accordance with Regulation .04J(3) of this chapter; (3) Delineation of roles, which includes: (a) Assigning each staff member clear roles and responsibilities; and (b) Ensuring that participant care plans identify providers and specialists involved in the participant's care; and (4) Monitoring and reassessment, which includes: (a) Monitoring and documenting participant health status and progress toward care plan goals; (b) Monitoring population health status and service use to determine adherence to or variance from treatment guidelines; and (c) Outcomes evaluation and reporting, which includes using eMedicaid and other available HIT tools such as electronic health records. C. Care Coordination and Health Promotion. (1) The health home shall coordinate and provide access to: (a) High-quality health care services; (b) Preventive and health promotion services, including education regarding: (i) Mental illness; (ii) Substance use disorders; and (iii) Chronic physical health conditions; (c) Mental health and substance abuse services; (d) Chronic disease management services; and (e) Long-term care supports and services. (2) The health home shall coordinate services and support, including: (a) Appointment scheduling; (b) Referrals and follow-up monitoring; (c) Hospital discharge processes; and (d) Communication with other providers and supports, including school service providers. (3) The health home shall assign each participant a health home care manager who is responsible for coordinating the participant's care and ensuring implementation of the care plan. (4) The health home shall develop policies and procedures to facilitate collaboration between primary care, specialist, and behavioral health providers, community-based organizations, and, for minors, school-based providers. (5) The health home shall follow security protocols to protect confidential health information. (6) The health home shall assist participants with the implementation of their care plan, including: (a) Health education specific to a participant's chronic conditions; (b) Development of a plan for self-management; (c) Medication review and education; and (d) Substance use prevention, smoking cessation, obesity reduction, improved nutrition, and increased physical activity. (7) A health home serving minors shall actively involve parents and families in providing services in accordance with §C(6) of this regulation, including: (a) Identifying conditions for which the minor may be at risk due to family, physical, or social factors; and (b) Working with the minor and parents and families to address the identified conditions. (8) The health home shall use the ASO system to document, review, and report health promotion services delivered to each participant. D. Comprehensive Transitional Care. (1) The health home shall provide services designed to: (a) Streamline plans of care; (b) Reduce avoidable hospital admissions; (c) Ease the transition to long-term services; (d) Interrupt patterns of frequent hospital emergency department use; and (e) Ensure timely and proper follow-up care across settings, including from: (i) An acute care setting to other settings; and (ii) A pediatric system of care to an adult system of care. (2) The health home shall increase participants' and caregivers' ability to manage care and live safely in the community. (3) The health home shall utilize CRISP to receive alerts of hospital admissions, discharges, or transfers among their health home participants. (4) The health home shall follow up with participants within 2 business days of discharge with a home visit, phone call, or scheduling an on-site appointment. E. Individual and Family Support Services. (1) Services shall include, but are not limited to: (a) Advocating for individuals and families; (b) Supporting participants in obtaining and adhering to medications and other prescribed treatments; (c) Accessing resources that support participants, including providing referrals for: (i) Community services; (ii) Social support services; (iii) Recovery services; and (iv) Transportation to medically necessary services; (d) Improving participants' health literacy; (e) Increasing the participant's ability to self-manage care; (f) Facilitating participation in the ongoing revision of the treatment plan; and (g) Providing information on advance directives and health care power of attorney. (2) The health home shall utilize peer supports, support groups, and self-care programs to: (a) Increase participants' and caregivers' knowledge of the participants' diseases; (b) Increase caregivers' care-management capabilities; (c) Promote participants' adherence to their plan of care; and (d) Increase participants' self-management capabilities. (3) The health home shall ensure that all communication shared with the participant, the participant's family, and caregivers is language, literacy, and culturally appropriate. F. Referral to Community and Social Support Services. The health home shall provide assistance in accessing and coordinating, as appropriate: (1) Medical assistance; (2) Disability benefits; (3) Subsidized or supported housing; (4) Personal needs support; (5) Peer support; or (6) Legal services. G. The health home shall assist in coordinating these services. H. Use of HIT to Link Services. The provider shall use HIT, including CRISP and the ASO system to: (1) Facilitate communication between health home staff members, the participant, and their caregivers; and (2) As appropriate, provide feedback to participants' other providers. I. Health home services provided by PRP, MTS, or OTP staff qualify as covered services. #### Regulation .07 Health Home Participant Flow. *COMAR 10.09.33.07* A. Enrollment. (1) The health home shall enroll an individual only after the individual has been enrolled in the health home provider's applicable PRP, MTS, or OTP services. (2) During enrollment, an OTP established as a health home shall identify eligible individuals under the OTP’s care and report the diagnoses related to qualifying risk factors set forth in Regulation .03A(2)(b) of this chapter in the ASO system. (3) The health home shall provide the individual with a brief description of health home services, including: (a) Explaining the data-sharing elements of the program; and (b) Describing how the individual may opt out if desired. (4) Following the provision of information in accordance with §A(3) of this regulation, the health home shall obtain the individual's consent to participate in the health home. (5) Following consent to participate in accordance with §A(4) of this regulation, the health home shall complete the individual's online intake report through the ASO system thereby enrolling the individual into the health home. (6) The health home shall: (a) Notify a participant's other treatment providers about health home services; and (b) Encourage other providers' participation in care coordination efforts. B. Participation. (1) A health home participant shall receive a minimum of two health home services per month, as defined in Regulation .06 of this chapter and to be documented in the ASO system. (2) An assigned health home care manager shall monitor the participant's care and health status and coordinate with other staff to provide appropriate health home services. C. Discharge. (1) In the event of discharge, the health home shall create a discharge plan that includes referrals to appropriate services and providers. (2) The health home shall report all discharges and completion of discharge plans in the ASO system. #### Regulation .08 Limitations. *COMAR 10.09.33.08* A. An eligible individual may not receive services from a health home provider that is not the individual’s PRP, MTS, or OTP provider. B. Health home services do not restrict or otherwise affect: (1) Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation; (2) The freedom of a participant to select from all available services for which the participant is found to be eligible; or (3) A participant’s free choice among providers in the Medical Assistance Program. C. The Department may not reimburse the health home provider for: (1) Activities that have already been billed to or counted towards a service requirement for another Medical Assistance Program or other program; (2) Activities not consistent with the definition of health home services under this chapter; (3) Activities delivered as part of institutional discharge planning that are not comprehensive transitional care services delivered by the health home; (4) A participant’s health home monthly rate more than once per month; (5) A participant’s health home monthly rate when the intake encounter is utilized by the provider as one of the two required monthly service encounters; (6) A participant’s health home monthly rate when the provider counts two encounters as having the same date of service, unless: (a) The modality of the two encounters is different because one was an individual encounter and one was a group encounter; or (b) The encounters are distinguishable by both the time at which they were rendered and the subject matter discussed; or (7) The health home monthly rate when the two required services were both rendered as group services. D. The Department may not reimburse for monthly health home services unless the individual receiving health home services: (1) Is Medicaid eligible at the time of service delivery and engaged in treatment or rehabilitation with either OTP or PRP or MTS services; (2) Is enrolled as a health home member at the billing health home provider; and (3) Has received a minimum of two health home services in the stated month that has been documented in the ASO system. E. Reimbursement will not be made for health home services if the participant is receiving a comparable service under another Medical Assistance Program or other program. F. A participant’s health home provider may not be the participant’s family member. #### Regulation .09 Payment Procedures. *COMAR 10.09.33.09* A. The Department shall reimburse the health home for covered services according to the requirements in this chapter and the rate established in §C of this regulation. B. Request for Payment. (1) The health home provider is authorized to bill for the intake and ongoing monthly rate for a participant when: (a) The participant is receiving PRP, MTS, or OTP services; and (b) The intake portion of the participant's ASO system file has been submitted and initial services have been delivered. (2) After completing the required health home service provision reporting in the ASO system, the health home provider shall, within 30 days from the end of the month during which health home services were provided, submit a request for payment for all participants who received two health home services during that month. (3) A health home provider shall bill the Department for the appropriate rate specified in §C of this regulation. C. The Department shall reimburse according to the following fee schedule: (1) For dates of service from July 1, 2023 through December 31, 2023, at a monthly rate of $131.03 per participant; (2) For dates of service from January 1, 2024 through June 30, 2024, at a monthly rate of $141.51; and (3) For dates of service beginning July 1, 2024, at a monthly rate of $145.76. #### Regulation .10 Recovery and Reimbursement. *COMAR 10.09.33.10* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .11 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.33.11* A. Cause for suspension or removal from the Medical Assistance Program and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. B. If the Department determines that a health home provider has failed to comply with the provisions of this chapter, the Department may initiate one or more of the following actions against the health home provider: (1) Recovery of overpayment made by the Department; (2) Withholding of payment by the Department; (3) Reduction in payment by the Department, including a 10 percent reduction in reimbursement for services that are not billed within the time frame required by Regulation .09B(2) of this chapter; (4) Suspension from being a health home provider; (5) Removal from being a health home provider; or (6) Disqualification from being a health home provider at any future time. #### Regulation .12 Appeal Procedures. *COMAR 10.09.33.12* Appeal procedures shall be as set forth in COMAR 10.09.36.09. #### Regulation .13 Interpretive Regulation. *COMAR 10.09.33.13* State regulations shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 34 — Therapeutic Behavioral Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: November 24, 2005 (32:23 Md. R. 1827) **Administrative History:** Regulation .01B amended effective May 2, 2011 (38:9 Md. R. 552); December 12, 2022 (49:25 Md. R. 1050) **Administrative History:** Regulation .02A amended effective February 15, 2016 (43:3 Md. R. 273); December 12, 2022 (49:25 Md. R. 1050) **Administrative History:** Regulation .03B amended effective December 12, 2022 (49:25 Md. R. 1050) **Administrative History:** Regulation .04 amended effective December 12, 2022 (49:25 Md. R. 1050) **Administrative History:** Regulation .04D amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .06C amended effective February 15, 2016 (43:3 Md. R. 273); December 12, 2022 (49:25 Md. R. 1050); August 21, 2023 (50:16 Md. R. 726) #### Regulation .01 Definitions. *COMAR 10.09.34.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Behavioral plan” means an individualized written plan for therapeutic behavioral services which includes the components specified in Regulation .03B(1) of this chapter. (2) “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396(a)—(v). (3) “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) provider” means any health care provider acting within the scope of the provider's practice who: (a) Screens, evaluates, or identifies a condition; and (b) Recommends treatment. (4) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (5) “Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits. (6) “Preauthorization” means the approval required from the Department, or its designee, before services may be rendered. (7) “Prescribed” means ordered in writing and signed by an EPSDT provider who has examined the participant and diagnosed the [recipient's] participant’s medical condition. (8) “Program” means the Maryland Medical Assistance Program. (9) “Rehabilitative service” means a medical or remedial service prescribed by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland, or the jurisdiction where services are rendered for: (a) Maximum reduction of physical or mental disability; and (b) Restoration of a participant’s best possible functional level. (10) “Therapeutic behavioral aide” means an individual who is: (a) A health care professional or a nonprofessional who is supervised by an individual who is licensed, certified, or otherwise legally authorized to provide mental health services independently in the state where the service is rendered; (b) Trained and supervised by a therapeutic behavioral service provider to implement a behavior plan; and (c) Available on-site to provide one-to-one behavioral assistance and intervention to accomplish outcomes specified in the behavioral plan. (11) “Therapeutic behavioral assessment” means a comprehensive assessment of a participant and, if applicable, a participant’s family that: (a) Is performed by a licensed or certified health care professional; (b) Addresses the medical and behavioral needs for therapeutic behavioral services; (c) Includes the risk of needing placement in a more restrictive living arrangement because of the behavior; and (d) Includes development of a behavioral plan. (12) “Therapeutic behavioral service” means an intensive, rehabilitative service that is documented in the written behavioral plan and is intended to: (a) Provide the participant with behavioral management skills to effectively manage the behaviors or symptoms that place the participant at risk for a higher level of care; and (b) Restore the participant’s previously acquired behavior skills and enable the participant to develop appropriate behavior management skills. (13) “Therapeutic behavioral service provider” means: (a) A Developmental Disabilities Administration provider meeting criteria set forth in COMAR 10.22.02; (b) An outpatient mental health clinic approved under COMAR 10.21.20; (c) A mental health mobile treatment unit meeting criteria set forth in COMAR 10.09.59; or (d) A psychiatric rehabilitation program approved under COMAR 10.21.29. #### Regulation .02 Conditions for Provider Participation. *COMAR 10.09.34.02* A. A therapeutic behavioral service provider shall: (1) Ensure that therapeutic behavioral aides are trained and supervised in: (a) Principles of behavior change and childhood development; (b) Clinically accepted techniques for decreasing or eliminating maladaptive behaviors; (c) Implementing a behavioral plan; (d) Identifying the needs and characteristics of the participant; and (e) Documenting interventions and outcomes; (2) If the therapeutic aide is not licensed or certified by a health practice licensure board to practice independently, ensure that a licensed healthcare practitioner shall: (a) Meet at least once every 2 weeks with the aide and review the progress and develop a plan of care for each participant assigned to the aide; and (b) At least once a month, observe the participant’s progress and needs with the participant’s parent or guardian; and (3) Provide a written progress note that is completed for each time period that a therapeutic behavioral aide spends with the participant and includes: (a) The location, date, start time, and end time of the service; (b) The name of the parent, guardian, or individual who customarily provides care present during the service; (c) A brief description of the service provided, including reference to the behavioral plan; (d) A description of the participant’s behaviors or symptoms; and (e) The signature of the behavioral aide. B. General requirements for provider participation in the Program are set forth in COMAR 10.09.36. #### Regulation .03 Covered Services. *COMAR 10.09.34.03* A. The Program covers the services listed in this chapter when the services are: (1) Diagnosed, identified, and prescribed by an EPSDT provider to be medically necessary; (2) Preauthorized by the Department or its designee; and (3) Delivered in accordance with the behavioral plan. B. The following services are covered: (1) Therapeutic behavioral assessment and reassessment that includes: (a) Development of a behavioral plan with the participant and parent, guardian, or individual who customarily provides care which specifically: (i) Identifies the target behaviors or symptoms that are placing the current living arrangement at risk or presenting a barrier to transition to a less restrictive living arrangement; (ii) Defines specific interventions to be used to resolve the behaviors or symptoms, including how a therapeutic aide will implement therapeutic behavioral services; (iii) Defines outcome measures that can be used to demonstrate the decreasing frequency of targeted behaviors; (iv) Defines alternative behaviors; (v) Defines the clinically accepted techniques for behavior change, including where, when, and the frequency of the techniques to be used and the risks and benefits of each; (vi) Details the strategies and skills for the participant and parent, guardian, or individual who customarily provides cares to provide continuity of care when therapeutic behavioral services are discontinued; (vii) Details emergency procedures to be implemented when the participant exhibits behaviors that pose harm to self or others; (viii) Contains written informed consent before implementation, of the parent or legal guardian, or if the participant is 18 years old or older, written informed consent of the participant; and (ix) Identifies the level or type of licensed healthcare professional responsible for monitoring the behavioral plan; and (b) Determination if therapeutic behavioral services are needed; (2) Therapeutic behavioral services that: (a) Provide one-to-one intervention for a specified period of time at the appropriate site in accordance with the behavioral plan; and (b) May include, but are not limited to: (i) Assisting the participant to engage in or remain engaged in appropriate activities; (ii) Minimizing the participant’s impulsive behavior; (iii) Providing immediate behavioral reinforcements; (iv) Providing time structuring activities; and (v) Collaboration with and support for parent, guardian, or individual who customarily provides care in the effort to provide ongoing behavioral support. #### Regulation .04 Limitations. *COMAR 10.09.34.04* A. To be eligible for therapeutic behavioral services the: (1) Participant shall be younger than 21 years old and enrolled in the Program; (2) Participant shall be assessed as having behaviors or symptoms related to a mental health diagnosis that places the individual's current living arrangement at risk and creates a risk for a more restrictive placement, or prevents transition to a less restrictive placement; (3) Participant’s behaviors or symptoms shall be safely and effectively treated in the community; and (4) Participant’s parent, guardian, or individual who customarily provides care shall be present during the provision of all therapeutic behavioral services to participate in the behavioral plan, unless there are clinical goals specifically addressed in the behavior plan that need to be achieved requiring that the parent, guardian, or individual who customarily provides care not be present. B. Therapeutic behavioral services shall meet the definition of rehabilitation services. C. Therapeutic behavioral services shall be: (1) Decreased proportionally when indicated by the participant’s progress; (2) Discontinued when the targeted outcomes have been reached; or (3) Reassessed for new targeted outcomes if progress on the current outcomes is not being achieved. D. A therapeutic behavioral service provider may not bill the Program for: (1) Services that are: (a) Provided in: (i) An intermediate care facility; (ii) An institution for mental disease; (iii) A hospital; or (iv) A crisis residential program; (b) Habilitative, custodial, or activities of daily living; (c) Not authorized by the Department or its designee; (d) Provided by a therapeutic behavioral aide who is a member of the participant’s immediate family or who resides in the participant’s home; (e) Not medically necessary; (f) Beyond the provider's scope of practice; (g) Not performed under the supervision of a licensed health care provider; (h) Rendered but not appropriately documented; (i) Part of another service paid for by the State; or (j) Rendered by mail, telephone, or otherwise not one-to-one, in person; (2) Services that duplicate the care and custody provided by another State agency pursuant to a court order or a voluntary placement agreement; (3) Respite services; (4) Seclusion or restrictive techniques; (5) Completion of forms or reports; (6) Broken or missed appointments; or (7) Travel to and from site of service. #### Regulation .05 Preauthorization. *COMAR 10.09.34.05* A. The Department or its designee shall require preauthorization for therapeutic behavioral services. B. The initial authorization shall be given for not more than 60 calendar days. C. Additional authorization beyond the initial authorization shall be requested at a minimum, every 60 days and in advance of the expiration of the previous authorization. D. Authorization may only be given if the therapeutic behavioral service continues to be effective and progress towards the specified goals is documented. #### Regulation .06 Payment Procedures. *COMAR 10.09.34.06* A. Request for payment of services shall be submitted in accordance with COMAR 10.09.36.04. B. Billing time limitations for claims submitted pursuant to this chapter as set forth in COMAR 10.09.36.06. C. Reimbursement for services covered under this chapter is as follows: (1) For dates of service from November 1, 2021 through June 30, 2022: (a) Initial therapeutic assessment and reassessment at a rate of $136.12; and (b) Therapeutic behavioral services at a rate of: (i) $29.50 for the first 30 minutes; and (ii) $14.75 for each additional 15 minutes. (2) Effective July 1, 2022: (a) Initial therapeutic assessment and reassessment at a rate of $145.99; and (b) Therapeutic behavioral services at a rate of: (i) $31.64 for the first 30 minutes; and (ii) $15.82 for each additional 15 minutes. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.34.07* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.34.08* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.34.09* Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.34.10* This chapter shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 35 — Hospice Care **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: October 1, 1989 (16:16 Md. R. 1751) **Administrative History:** Regulation .08G amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .08G amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Chapter revised effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .01B amended effective July 22, 2013 (40:14 Md. R. 1174) **Administrative History:** Regulation .04 amended effective July 22, 2013 (40:14 Md. R. 1174) **Administrative History:** Regulation .05 amended effective July 22, 2013 (40:14 Md. R. 1174) **Administrative History:** Regulation .07B, C amended effective July 22, 2013 (40:14 Md. R. 1174) **Administrative History:** Regulation .08 amended effective July 21, 2025 (52:14 Md. R. 712) #### Regulation .01 Definitions. *COMAR 10.09.35.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Attending physician” means: (a) A doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State; or (b) A nurse practitioner who meets the qualifications set forth in COMAR 10.27.07. (2) “Bereavement counseling” means counseling services provided to the participant's family after the participant's death. (3) “Cap period” means the 12-month period beginning November 1 of each year and ending October 31 of the following year, which is used in the annual application of the limitation on reimbursement at the general inpatient and inpatient respite care rates. (4) “Core services” means the hospice services that must routinely be provided directly by hospice employees, that is, nursing care, physician services, medical social services, and counseling. (5) “Department” means the Department as defined in COMAR 10.09.36.01. (6) “Election period” means a period for which a recipient may elect to receive hospice care in accordance with Regulation .04 of this chapter. (7) “Health Maintenance Organization (HMO)” means an organization which has contracted with the Department to deliver specific health care services to recipients in accordance with COMAR 10.09.16. (8) “Home” means that place of residence occupied by a participant. For purposes of hospice care, home may include a nursing facility. (9) “Hospice” means a public agency or private organization or subdivision of either of these that: (a) Is primarily engaged in providing care to terminally ill individuals; (b) Meets all applicable State and local licensing and regulatory requirements; and (c) Is participating in Medicare as a hospice care provider. (10) “Hospice nurse practitioner” means a nurse practitioner who: (a) Is an employee of the hospice; and (b) Meets the qualifications set forth in COMAR 10.27.07. (11) “Hospice physician” means a doctor of medicine or osteopathy who is: (a) Employed by or contracted by the hospice; and (b) Legally authorized to practice medicine and surgery by the State. (12) “Hospital” means an institution which is participating in Medicare or in a Medical Assistance Program as a hospital. (13) “Interdisciplinary group” means a group of provider employees who provide or supervise hospice care, and include at least a: (a) Doctor of medicine or osteopathy; (b) Registered nurse; (c) Social worker; and (d) Pastoral or other counselor. (14) “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. (15) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons, jointly financed by the federal and State governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (16) “Medicare” means Medicare as defined in COMAR 10.09.36.01. (17) “Nursing facility” means a facility or a distinct part of a facility which is participating in a Medical Assistance Program as a nursing facility provider. (18) “Participant” means a recipient who is eligible, has elected, and is receiving hospice care in accordance with the provisions of this chapter. (19) “Plan of care” means a written, individualized care plan established and maintained for each recipient enrolled by a hospice provider. (20) “Program” means the Maryland Medical Assistance Program. (21) “Provider” means a hospice that meets the requirements of Regulation .03 of this chapter and which, through a provider agreement signed with the Department, has been identified as a Program provider by the issuance of an individual account number. (22) “Provider agreement” means a contract between the Department and the provider. (23) “Recipient” means recipient as defined in COMAR 10.09.36.01. (24) “Representative” means a person who is, because of the recipient's mental or physical incapacity, authorized, in accordance with the State law to execute or revoke an election for hospice care, to advise concerning the plan of care, or to terminate medical care on behalf of the terminally ill individual. (25) “Respite care” means short-term care furnished to a participant for the purpose of providing rest or relief for family members or other individuals routinely furnishing at-home care to the participant. (26) “Room and board” means services provided to a participant who is a nursing facility resident. (27) “Skilled nursing facility” means a nursing facility or a distinct part of a nursing facility which is participating in Medicare as a skilled nursing facility. (28) “Terminally ill” means that the individual has a medical prognosis of a life expectancy of 6 months or less if the illness runs its normal course. #### Regulation .02 Licensing Requirements. *COMAR 10.09.35.02* A. In order to participate in the Program, a provider shall be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 9, Annotated Code of Maryland, or shall be legally authorized to provide hospice care in the jurisdiction in which the services are provided, and shall obtain other licenses as may be required by applicable State and local laws. B. Employees of the provider who provide hospice care services must be licensed, certified, or registered in accordance with applicable federal, State, and local laws. #### Regulation .03 Conditions of Participation. *COMAR 10.09.35.03* A. General requirements for participation in the Program are that providers shall: (1) Meet all conditions for participation as set forth in COMAR 10.09.36.03, except as otherwise specified in this regulation; and (2) Ensure that the licensure requirements as provided in Regulation .02 of this chapter are met. B. Specific requirements for participation in the Program as a hospice care provider are that the provider shall: (1) Meet the requirements of §A of this regulation. (2) Be a participating Medicare hospice. (3) Provide information about a participant's election, continuation, and termination of hospice care in accordance with procedures established by the Program. (4) Provide directly or make available through arrangements the covered services in Regulation .06 of this chapter. (5) Make nursing services, physician services, and drugs and biologicals routinely available on a 24-hour basis. (6) Make all other covered services available on a 24-hour basis to the extent necessary to meet a participant's needs for care as specified in the participant's plan of care. (7) Have a written policy, approved by the Program, which assures that the release of information from the participant's record is handled in accordance with applicable State and federal laws and regulations governing confidentiality. (8) Ensure that all core services are routinely provided directly by the provider's employees. Volunteers under the jurisdiction of the provider are considered provider employees. Contracted staff may be used to supplement employees only when necessary during periods of peak patient loads, under extraordinary circumstances, or to obtain physician specialty services. (9) Provide bereavement counseling, even though it is not a reimbursable service. #### Regulation .04 Duration of Hospice Care. *COMAR 10.09.35.04* A. An individual may elect to receive hospice care during one or more of the following election periods: (1) An initial 90-day period; (2) A subsequent 90-day period; or (3) An unlimited number of subsequent 60-day periods. B. The periods of care indicated in §A of this regulation are available in the order listed and may be elected separately at different times. C. An election period or an extended election period shall terminate before expiration when one of the following conditions is met: (1) The participant dies; (2) The election of hospice care is revoked in accordance with Regulation .05D of this chapter; (3) The participant's eligibility for Medical Assistance is cancelled; (4) The Program determines that the election period or extended election period shall be terminated for cause. Cause for termination may include, but shall not be limited to: (a) A change in the participant's prognosis as being terminally ill; (b) Relocation by the participant to a place of residence where a hospice care provider is not available; or (c) Action or behavior of the participant that makes continuation of hospice care inappropriate, such as misconduct, fraud, or repeated instances of willfully and knowingly seeking services related to the terminal illness from other than the designated provider. D. When a participant revokes the election of hospice care, in accordance with Regulation .05D of this chapter, during an election period, any remaining days in that election period shall be forfeited. Thereafter, the participant may elect hospice coverage for any remaining election periods for which the participant is eligible. E. When a participant revokes the election of hospice care during an extended election period, further Program coverage of hospice care shall be forfeited. F. The waiver of rights to Program payments described in Regulation .05B(5) of this chapter shall expire as of the effective date of termination of the election period or extended election period. #### Regulation .05 Eligibility for and Election of Hospice Care. *COMAR 10.09.35.05* A. To be eligible for hospice care, written certification of terminal illness shall be obtained by the hospice for each of the election periods listed in Regulation .04 of this chapter. Procedures for certification of terminal illness are as follows: (1) The hospice shall obtain the written certification before the hospice submits a claim for payment; (2) If the hospice is unable to obtain written certification within 2 calendar days after an election period begins, an oral certification shall be obtained within 2 calendar days and a written certification shall be obtained before the hospice submits a claim for payment; (3) Certifications shall be completed not more than 15 calendar days before the start of the election period; (4) For the initial election period, the hospice shall obtain written certification statements and shall document oral certification statements in accordance with §A(2) of this regulation from: (a) The medical director of the hospice or the physician member of the hospice interdisciplinary team; and (b) The attending physician, if there is an attending physician; (5) For subsequent election periods, certification by one of the physicians listed in §A(4) of this regulation is required; (6) All certifications shall: (a) Be signed and dated by the certifying physician; and (b) Include the date of the election for which the certification applies; (7) Certifications shall be based on the certifying physician’s clinical judgment regarding the normal course of the recipient’s illness and conform to the following requirements: (a) Document that the participant’s prognosis is for a life expectancy of 6 months or less if the terminal illness runs its normal course; (b) Clinical information documenting the prognosis of a terminal illness shall accompany the certification and shall be filed in the medical record; (c) Clinical information for the initial election period may be provided orally and shall be documented in the medical record and included as part of the hospice’s eligibility assessment; (d) A brief narrative written by the certifying physician: (i) Shall be included in the certification; (ii) Shall be located immediately before the certifying physician’s signature or included as an addendum signed by the certifying physician; (iii) Shall include a statement inserted directly above the certifying physician’s signature and based on a review of the participant’s medical record or examination of the participant; (iv) Shall reflect the participant’s individual clinical circumstances; and (v) May not contain checkboxes or standard language used for all participants; (8) To determine continued eligibility for hospice care, a face-to-face encounter by the hospice physician or the hospice nurse practitioner shall occur: (a) When a stay across all hospices is anticipated to reach the third election period; and (b) Not more than 30 days before the third election period and any subsequent election period; and (9) A narrative associated with an election period requiring a face-to-face encounter shall include: (a) An explanation of why the clinical findings support a prognosis of a terminal illness; and (b) A written attestation of the date of the encounter and that the clinical findings were provided to the certifying physician. B. A recipient 21 years old or older meeting the eligibility requirements and electing to receive hospice care shall file a signed election declaration with the provider which shall contain the following: (1) A statement that the recipient or the representative elects hospice care for the recipient; (2) Identification of the provider that will furnish hospice care to the recipient; (3) The effective date of the election, which may not be earlier than the date that the election is made; (4) A statement that the recipient or representative acknowledges being given a full description of hospice care and of its palliative rather than curative nature as it relates to the recipient's terminal illness and related conditions; (5) A statement that the recipient or representative understands that the recipient waives all rights to Program payments for the duration of the election of hospice care for the following services: (a) Hospice care provided by a hospice other than the provider designated by the recipient or representative, unless provided under arrangements made by the designated provider; and (b) Any services covered by the Program that are related to treatment of the terminal condition or a related condition, or that are equivalent to hospice care, except for services provided by: (i) The designated provider; (ii) Another hospice under arrangements made by the designated provider; (iii) The recipient's attending physician if that physician is not an employee of the designated provider or receiving compensation from the provider for those services; or (iv) A nursing facility as room and board, if the recipient is a resident of a nursing facility and would be eligible under the Program for nursing facility services if hospice care was not elected; and (6) The signature of the recipient or representative. C. A recipient younger than 21 years old meeting the eligibility requirements and electing to receive hospice care shall file a signed election declaration with the provider which shall contain the following: (1) A statement that the recipient or the representative elects hospice care for the recipient; (2) Identification of the provider that will furnish hospice care to the recipient; (3) The effective date of the election, which may not be earlier than the date that the election is made; (4) A statement that the recipient or representative acknowledges being given a full description of hospice care and of its palliative nature as it relates to the recipient's terminal illness and related conditions; (5) A statement that the recipient or representative understands that hospice services shall be made available without forgoing Program payments for curative treatment for the terminal illness; and (6) The signature of the recipient or representative. D. The election of hospice care shall be considered to continue uninterrupted through the first election period and through any subsequent election periods and any extended election periods, as long as the participant: (1) Remains in the care of a provider; and (2) Does not have the hospice care terminated under the provisions of Regulation .04D of this chapter. E. The election of hospice care may be revoked by the participant or representative at any time for any reason during an election period or an extended election period. Revocation requires the following: (1) The participant or representative shall file a statement with the provider that includes the following information: (a) A statement that the participant or representative revokes the election of Program coverage of hospice care and understands that the participant forfeits the remaining days in the election period; (b) The date that the revocation is to be effective, which may not be earlier than the date the revocation is made; and (c) The signature of the participant or representative. (2) As of the effective date of the revocation of the election of hospice care, the recipient: (a) Is no longer covered under the Program for hospice care; (b) Resumes Program coverage of services waived under §B(5) of this regulation; and (c) Forfeits Program coverage of hospice care for any days remaining in the election period, but may at a future time elect hospice care for any remaining election period for which the recipient is eligible. F. A participant may designate a new provider of hospice care not more than once during an election period. Designation shall be as follows: (1) The designation of a new provider is not a revocation of the election of hospice care under §D of this regulation. (2) To designate a new provider, the participant or representative shall file with the previously designated provider and with the newly designated provider, a statement that includes the following information: (a) The names of the previously designated provider and the new provider; (b) The effective date of the change of providers; and (c) The signature of the participant or representative. (3) A change in ownership of the provider is not considered a change in the participant's designation of a provider and requires no action on the participant's part. G. The provider shall maintain the statements described in this regulation and provide copies or related information to the Program on request. #### Regulation .06 Covered Services. *COMAR 10.09.35.06* A. Hospice care includes the services listed in §B of this regulation when the services are: (1) Provided to an eligible recipient who elects hospice care, in accordance with Regulation .05 of this chapter; (2) Reasonable and necessary for the palliation or management of the participant's terminal illness and related conditions; (3) Consistent with the plan of care established before the services are provided; (4) Provided by appropriately qualified personnel; (5) Administered according to accepted standards of practice; and (6) Routinely provided directly by provider employees, when they are the core services listed in §B(1)—(4) of this regulation, except that the provider may contract for supplemental services during peak patient loads, under extraordinary circumstances, or to obtain physician specialty services. B. The following are covered hospice care services: (1) Nursing care provided by a nurse licensed as a registered nurse in the jurisdiction in which services are provided or by an individual under the supervision of a registered nurse; (2) Medical social services provided by a social worker who is: (a) In compliance with the social work licensing requirements of the jurisdiction in which service is provided; and (b) Working under the direction of a physician; (3) Physician services performed by a physician as described in 42 CFR §§410.20—410.25, except that the services of the provider's medical director or physician member of the interdisciplinary group shall be performed by a doctor of medicine or osteopathy; (4) Counseling services provided to the participant and the family members or other persons caring for the participant at home, including: (a) Dietary counseling; (b) Counseling to train the participant's family or other caregivers in providing care; (c) Spiritual counseling to help the participant and the family or other caregivers in the home to adjust to the participant's approaching death; (d) Bereavement counseling for the family after the participant's death; and (e) Additional counseling provided by interdisciplinary group members, as well as by other qualified professionals as necessary; (5) Short-term inpatient care subject to the following conditions: (a) General inpatient care may be provided to meet the participant's needs for pain control or for acute or chronic symptom management that cannot be met in other settings; (b) Inpatient respite care may be furnished to provide rest or relief for family members or other individuals routinely furnishing at-home care to the participant; and (c) General inpatient care and inpatient respite care shall be provided in a: (i) Hospice that meets the conditions of participation for providing inpatient care directly as set forth in 42 CFR §418.100; or (ii) Hospital, skilled nursing facility, or nursing facility that meets the special hospice standards regarding 24-hour nursing service and patient areas as set forth in 42 CFR §418.100(a) and (e); (6) Medical appliances and supplies, including drugs and biologicals, which are needed for the palliation and management of the terminal illness and related conditions; (7) Home health aide and homemaker services furnished by qualified individuals, who are under the general supervision of a registered nurse; and (8) Physical therapy, occupational therapy, and speech-language pathology services provided by qualified individuals for purposes of symptom control or to enable the participant to maintain activities of daily living and basic functional skills. #### Regulation .07 Limitations. *COMAR 10.09.35.07* When a recipient is enrolled in Medicare Part A, Program payment for hospice care shall be limited to payment of the recipient's Medicare hospice care co-insurance amounts for drugs and biologicals and for respite care and, where applicable, room and board for residents of a nursing facility under Regulation .08E of this chapter. #### Regulation .08 Payment Procedures. *COMAR 10.09.35.08* A. Reimbursement Principles. (1) The Program shall pay the provider at one of four rate categories for each day that the participant is under the provider's care, subject to the conditions, limitations, and exceptions set forth in this chapter. (2) The payment rates for providers shall be those established by the Centers for Medicare and Medicaid Services of the U.S. Department of Health and Human Services for hospice care under a Medical Assistance Program. (3) The daily rates are prospective rates, and there shall be no retroactive adjustment of payment other than the limitation on payment for inpatient care set forth in §C of this regulation. B. Categories of Hospice Care for Reimbursement. (1) Routine Home Care. (a) The provider shall be paid the routine home care rate for each day the participant is under the care of the provider and another rate is not payable under §B(2)—(4) of this regulation. (b) The routine home care rate is paid without regard to the volume or intensity of covered services provided on a given day. (c) The routine home care rate is paid at one of the following levels, whichever is applicable: (i) An enhanced rate for the first 60 days in which the participant is enrolled in hospice; or (ii) A lesser rate for day 61 and thereafter. (2) Continuous Home Care. (a) The provider shall be paid the continuous home care rate for each day the participant is at home, under the care of the provider, and all of the following requirements are met: (i) There is a brief period of crisis during which the participant requires continuous care, which is primarily nursing care to achieve palliation or management of acute medical symptoms. (ii) Nursing care shall be provided by either a registered nurse or a licensed practical nurse, and a nurse must be providing care for more than half the period. Homemaker or home health aide services may be provided to supplement the nursing care. (iii) A minimum of 8 hours of care must be provided during a 24-hour day which begins and ends at midnight, but the hours of care need not be continuous. (b) The continuous home care rate is divided by 24 hours to arrive at an hourly rate. (c) For every hour or part of an hour of continuous home care furnished, the hourly rate shall be paid to the provider, up to 24 hours a day. (d) If less skilled care is needed on a continuous basis to maintain the patient at home during a period of crisis, or if less than 8 hours of continuous home care is provided during a day, payment shall be made at the routine home care rate. (3) Inpatient Respite Care. (a) The provider shall be paid the inpatient respite care rate for each day the participant is in a qualified inpatient facility for the purpose of respite care, subject to the following requirements: (i) Payment shall be made at the inpatient respite care rate for a maximum of 5 consecutive days at a time, including the day of admission but not counting the day of discharge; (ii) Payment for the sixth and any subsequent day of inpatient respite care shall be made at the routine home care rate; (iii) For the day of discharge, payment shall be made at the routine or continuous home care rate, as appropriate, unless the participant dies as an inpatient; and (iv) Payment shall be made at the inpatient respite care rate for the day of discharge if the participant is discharged deceased. (b) Inpatient respite care may not be provided when the participant is a resident of a nursing facility. (4) General Inpatient Care. The provider shall be paid the general inpatient care rate for each day the participant is in a qualified inpatient facility for care, subject to the following requirements: (a) The inpatient care is required for procedures necessary for pain control or for acute or chronic symptom management which cannot be provided in other settings; (b) Payment shall be made at the general inpatient rate for the day of admission and for all subsequent inpatient days, except for the day of discharge; (c) For the day of discharge, payment shall be made at the routine or continuous home care rate, as appropriate, unless the participant dies as an inpatient; and (d) Payment shall be made at the general inpatient rate for the day of discharge if the participant is discharged deceased. C. Limitation on Payment for Inpatient Care. (1) Payment to a provider for inpatient care shall be limited according to the total number of days of inpatient care the provider furnished to participants during a specific cap period, excluding the days of inpatient care furnished to participants diagnosed with Acquired Immune Deficiency Syndrome (AIDS). (2) For the cap period, the aggregate number of inpatient days reimbursed for general inpatient and inpatient respite care (excluding inpatient days reimbursed for participants with AIDS) may not exceed 20 percent of the aggregate total number of days of hospice care the provider furnished to all participants (excluding days of hospice care furnished to participants with AIDS) during the same period. (3) The limitation on payment for inpatient care days is calculated as follows: (a) Subtract the days of care furnished to participants with AIDS from the total days of care furnished by the provider to all participants during the cap period; (b) Subtract the days of inpatient care furnished to participants with AIDS from the total days of inpatient care furnished by the provider to all participants during the cap period; (c) The maximum allowable number of reimbursable inpatient days is determined by multiplying by 0.2 the adjusted total number of days of hospice care the provider furnished to participants during the cap period, as determined in §C(3)(a) of this regulation; (d) If the adjusted total number of inpatient care days the provider furnished to participants during the cap period, as determined in §C(3)(b) of this regulation, is less than or equal to the maximum allowable number of reimbursable inpatient days, no payment adjustment is necessary; and (e) If the adjusted total number of inpatient care days the provider furnished to participants during the cap period exceeds the maximum allowable number of reimbursable inpatient days, the payment limitation and the refund to the Program shall be determined by: (i) Calculating a ratio of the maximum allowable number of reimbursable inpatient days to the adjusted total number of inpatient care days, and multiplying this ratio by the total reimbursement to the provider during the cap period for general inpatient and inpatient respite care days (minus the reimbursement for inpatient care days furnished to participants with AIDS); (ii) Multiplying excess inpatient care days by the routine home care rate; (iii) Adding together the amounts calculated in §C(3)(e)(i) and (ii) of this regulation; and (iv) Refunding to the Program the difference between the interim reimbursement made for non-AIDS inpatient care during the cap period and the amount determined in §C(3)(e)(iii) of this regulation. (4) This limitation shall be applied once a year, at the end of the cap period. D. Service Intensity Add-On. (1) In addition to the routine home care rate paid under §B(1) of this regulation, the provider shall be paid for visits made by a social worker or a registered nurse, when provided during routine home care in the last 7 days of the participant’s life. (2) The service intensity add-on payment is equal to the continuous home care hourly rate divided by four. (3) The provider shall be paid in 15-minute increments for a maximum of four hours daily. E. Payment for Physician Services. (1) The per diem rates are designed to reimburse for those administrative and general supervisory activities performed by physicians who are employees of or are working under arrangements with the provider. These activities are generally performed by the physician serving as the medical director or the physician member of the provider's interdisciplinary group. The included activities consist of participation in establishment of care plans, supervision of service delivery, periodic review and updating of care plans, and establishment of governing policies. (2) In addition to the daily rates, the Program shall make separate payment to the provider for physician services, subject to the following requirements: (a) The services shall be direct patient care services furnished to a participant under the care of the provider; (b) The services shall be furnished by an employee of the provider or furnished under arrangements made by the provider; (c) The provider shall have a liability to reimburse the physician for the services rendered; (d) The provider shall bill for the physician services in accordance with procedures established by the Program; (e) A payment may not be made for physician services furnished on a volunteer basis; and (f) Payment to the provider for physicians' services shall be made in accordance with the fee schedule contained in COMAR 10.09.02. (3) A physician who is designated as the attending physician by a participant and who also volunteers services to the provider is considered an employee of the provider, whose direct patient care services furnished to the participant on a nonvolunteer basis shall be reimbursed to the provider in accordance with §D(2) of this regulation. (4) A physician who is designated as the attending physician by a participant and who is not an employee of the provider or receiving compensation from the provider shall be paid by the Program in accordance with COMAR 10.09.02. The attending physician may bill the Program only for personal professional services. F. When a participant resides in a nursing facility, the Program shall pay an additional per diem amount for room and board to the provider, subject to the following requirements: (1) The additional amount shall be paid only for those days that the provider is reimbursed at the routine or continuous home care rate for hospice care furnished to the participant; (2) The amount shall be the per diem reimbursement established by the Program to pay for room and board in the facility; (3) The amount shall be paid to the provider only when the provider and the facility have a written agreement under which the provider is responsible for the professional management of the participant's hospice care and the facility agrees to provide room and board to the participant; (4) While the provider is being reimbursed for hospice care furnished to a participant residing in a nursing facility, Program payment to the facility shall be discontinued; and (5) The Department of Human Services shall determine the application of a recipient's resource to the cost of hospice care pursuant to COMAR 10.09.24 and COMAR 10.09.25. The provider: (a) Shall collect a recipient's resource available for hospice care as certified by the Department of Human Services, (b) May not collect a total payment, including the recipient's resource and the Department's payment, which exceeds the amount the provider would be paid in accordance with this regulation for a day of hospice care, and (c) Shall show sums collected from a recipient's available resource as patient collection. G. Requests for Payment. Requests for payment for hospice care services rendered shall be submitted as set forth in COMAR 10.09.36.04. H. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .09 Recovery and Reimbursement. *COMAR 10.09.35.09* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .10 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.35.10* Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .11 Appeal Procedures. *COMAR 10.09.35.11* Appeal procedures for providers shall be as set forth in COMAR 10.09.36.09. #### Regulation .12 Interpretive Regulation. *COMAR 10.09.35.12* State regulations shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 36 — General Medical Assistance Provider Participation Criteria **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective July 1, 1990 (17:15 Md. R. 1851); adopted permanently effective October 1, 1990 (17:18 Md. R. 2201) **Administrative History:** Regulations .01A and .03A amended, and .03D adopted as an emergency provision effective February 27, 1992 (19:6 Md. R. 669); adopted permanently effective June 22, 1992 (19:11 Md. R. 1015) **Administrative History:** Regulations .01A, .06A, B amended, and .06C—E adopted as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulations .01A and .06 amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .01B amended effective May 9, 2005 (32:9 Md. R. 849); August 27, 2007 (34:17 Md. R. 1507); January 24, 2011 (38:2 Md. R. 84); July 4, 2016 (43:13 Md. R. 712); June 14, 2021 (48:12 Md. R. 473); September 18, 2023 (50:18 Md. R. 794); August 5, 2024 (51:15 Md. R. 707); July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .02 amended effective September 18, 2023 (50:18 Md. R. 794) **Administrative History:** Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .03 amended effective January 1, 2018 (44:26 Md. R. 1215); September 18, 2023 (50:18 Md. R. 794); July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .03A amended effective June 14, 2010 (37:12 Md. R. 800); December 10, 2012 (39:24 Md. R. 1577); November 11, 2013 (40:22 Md. R. 1877); February 16, 2015 (42:3 Md. R. 316); March 28, 2016 (43:6 Md. R. 407); July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .03-1 adopted effective February 26, 2018 (45:4 Md. R. 206) **Administrative History:** Regulation .03-2 adopted effective April 4, 2022 (49:7 Md. R. 466); amended effective August 5, 2024 (51:14 Md. R. 707) **Administrative History:** Regulation .04 amended effective August 5, 2024 (51:15 Md. R 707) **Administrative History:** Regulation .04H amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .05D adopted effective August 12, 1996 (23:16 Md. R. 1175) **Administrative History:** Regulation .06 amended effective June 1, 1993 (20:10 Md. R. 852); January 12, 2009 (36:1 Md. R. 21); June 27, 2011 (38:13 Md. R. 755) **Administrative History:** Regulation .07 amended effective September 18, 2023 (50:18 Md. R. 794) **Administrative History:** Regulation .07C, D adopted effective May 9, 2005 (32:9 Md. R. 849) **Administrative History:** Regulation .08A, D amended effective June 14, 2021 (48:12 Md. R. 473) **Administrative History:** Regulation .08C adopted effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .09 repealed and new Regulation .09 adopted effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .09 amended effective June 14, 2021 (48:12 Md. R. 473) **Administrative History:** Regulation .09A amended effective September 18, 2023 (50:18 Md. R. 794) **Administrative History:** Regulation .10 amended effective September 18, 2023 (50:18 Md. R. 794) **Administrative History:** Regulation .11 adopted effective June 27, 2011 (38:13 Md. R. 755) **Administrative History:** Regulation .11D amended effective September 18, 2023 (50:18 Md. R. 794) #### Regulation .01 Definitions. *COMAR 10.09.36.01* A. The following terms apply to Medical Assistance providers. Additional defined terms, unique to Medical Assistance provided services, are found in Medical Assistance service-specific chapters. B. Terms Defined. (1) “Abandoned” means failing to appear for a hearing on the established date without good cause. (2) “Administrative law judge” means an individual appointed by the Chief Administrative Law Judge under State Government Article, §9-1604, Annotated Code of Maryland, or designated by the Chief Administrative Law Judge under State Government Article, §9-1607, Annotated Code of Maryland, to: (a) Adjudicate contested cases at the Maryland Office of Administrative Hearings; and (b) Render a proposed decision for purposes of COMAR 28.02.01.22. (3) “Care manager” means a: (a) Primary medical provider under the Diabetes Care Program, in accordance with COMAR 10.09.43, or the Maryland Access to Care Program, in accordance with COMAR 10.09.44; (b) Primary care provider under the corrective managed care program, in accordance with COMAR 10.09.24.15B and 10.09.25.14B; or (c) Hospice provider under the hospice care program, in accordance with COMAR 10.09.35. (4) “Claim” means: (a) A bill for services; (b) A line item of service; or (c) All services for one participant within a bill. (5) Clean Claim. (a) “Clean claim” means a claim that can be processed consistent with applicable regulations without obtaining additional information from the provider of the service or from a third party. (b) “Clean claim” includes a claim with errors originating in a State's claims system; (c) “Clean claim” does not include a claim: (i) From a provider who is under investigation for fraud or abuse; or (6) “Current Procedural Terminology (CPT)” means the American Medical Association’s uniform nomenclature for coding medical procedures and services. (7) “Customary charge” means the uniform amount that the provider charges in the majority of cases for a specific item or service, excluding token charges for charity patients and substandard charges for welfare and other low-income patients. (8) “Department” means the Maryland Department of Health, which is the single state agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (9) “Emergency services” means those services which are provided in hospital emergency facilities after the onset of a medical condition manifesting itself by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent layperson, possessing an average knowledge of health and medicine, to result in: (a) Placing health in jeopardy; (b) Serious impairment to bodily functions; (c) Serious dysfunction of any bodily organ or part; or (d) Development or continuance of severe pain. (10) “Healthcare Common Procedure Coding System (HCPCS)” means the specified code set for procedures and services, according to the Health Insurance Portability and Accountability Act (HIPAA). (11) “Managed care" means the care manager's provision of comprehensive primary care and referral services to an enrollee in a managed care program. (12) “Managed care program” means: (a) Maryland Access to Care Program under COMAR 10.09.44; (b) Diabetes Care Program under COMAR 10.09.43; (c) Corrective managed care under COMAR 10.09.24.15B or 10.09.25.14B; or (d) Hospice care under COMAR 10.09.35. (13) “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (14) “Medical Care Programs" means the unit of the Department responsible for the administration of the Medical Assistance Program. (15) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (16) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (17) Overpayment. (a) “Overpayment” means any payment made by the Medicaid Program to a provider for medical care provided to a participant which at the time of payment, or at a subsequent date, is determined to be: (i) A duplicate payment; (ii) A payment for services for which reimbursement is claimed when all or any part of the claim submitted to the Department is for services that were provided in violation of one or more regulations; (iii) Excessive in amount; or (iv) The primary obligation of a health insurance carrier or any other person, including the participant, who is legally or contractually obligated to pay for that medical care. (b) “Overpayment” does not include an amount recovered as part of a routine cost settlement process. (18) “Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. (19) “Primary care” means that medical care which addresses a patient's general health needs including the coordination of the patient's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, and referral to other specialists for more intensive care when appropriate. (20) “Program" means the Medical Assistance Program. (21) “Provider” means: (a) An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Program participants and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number; (b) An agent, employee, or related party of a person identified in §B(19)(a) of this regulation; or (c) An individual or any other person with an ownership interest in a person identified in §B(19)(a) of this regulation. (22) “State Department of Assessments and Taxation (SDAT)” means the State Department of Assessments and Taxation as described in COMAR Title 18. (23) “Withhold payment” means the Program's decision to not pay or suspend payment to a provider as a sanction for failure to comply with applicable federal or State laws or regulations or because of a credible allegation of fraud. #### Regulation .02 License Requirements. *COMAR 10.09.36.02* Medical Assistance Program providers shall, to the extent required by law, be licensed, certified, or otherwise legally authorized to practice or deliver services in the state in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.36.03* A. To participate in the Program, the provider shall: (1) Ensure compliance with all the Medical Assistance provisions listed in the Code of Maryland Regulations (COMAR) designated for their provider type; (2) Apply for participation in the Program using the application form designated by the Department; (3) Obtain and maintain in good standing the appropriate SDAT identification number in accordance with §I of this regulation; (4) Be approved for participation by the Department; (5) Allow the Department or its agents to conduct unannounced on-site inspections of any and all provider locations; (6) Allow the Department or its agents to require all providers to consent to criminal background checks, including fingerprinting; (7) Have a current provider agreement with the Program in effect and fully comply with the terms and conditions stated in the provider agreement; (8) Comply with all standards of practice, professional standards and levels of service as set forth in all applicable federal and State laws, statues, rules, and regulations as well as all administrative policies, procedures, transmittals, and guidelines issued by the Department; (9) Charge the Program the provider's customary charge to the general public for similar items or services. If the item or service is free to individuals not covered by Medicaid: (a) The provider: (i) May charge the Program; and (ii) Shall be reimbursed in accordance with the Department's rate provisions; and (b) The provider's reimbursement is not limited to the provider's customary charge. (10) Maintain adequate records for a minimum of 6 years and make them available, upon request, to the Department or its designee; (11) Accept payment by the Program as payment in full for covered services rendered and make no additional charge to any person for covered services; (12) Provide services without regard to race, color, age, sex, national origin, religion, sexual orientation, gender identity, marital status, or physical or mental disability; (13) Verify the participant’s eligibility by: (a) Viewing the participant’s Medical Assistance card and another identification card; and (b) Calling the Program's Eligibility Verification Interactive Voice Response System (EVS/IVR) or accessing the web-based participant eligibility system; (14) Place no restriction on a participant’s right to select health care providers of the participant’s choice, except that a participant in a managed care program shall be required to obtain certain specified Program services from or through the participant's care manager, in accordance with the restrictions imposed by the managed care program; (15) Not knowingly employ or contract with a person, partnership, or corporation which has been disqualified from the Program to provide or supply services to Medical Assistance participants unless prior written approval has been received from the Department; (16) Notify the Department or its designee of patient activity or circumstance that affects placement, eligibility, or reimbursement, on the form and at the time specified by the Department; (17) Maintain the confidentiality of all participant information by not releasing the information without authorization by the participant or as authorized by law; (18) Have an individual rendering number for practitioners recognized by the Program; (19) Obtain a referral from a participant’s care manager in a manner prescribed by the Department before rendering services, when: (a) The participant is enrolled in a managed care program; and (b) The service is included under the managed care program's referral requirements. (20) Supply a signed service order or prescription that includes the individual rendering number of the ordering or prescribing practitioner, as well as the full name and Medical Assistance number of the participant, when ordering services to be supplied by other providers, such as hospital admission, diagnostic testing, supplies, or pharmacy services; (21) Ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed; (22) Provide a participant’s medical records at no charge when the records are requested by another physician or licensed provider on behalf of the participant; and (23) Comply with the requirements of COMAR 10.01.04.12 regarding the designation of an authorized representative; (24) Place no restriction on a participant’s fair hearing appeal rights as a condition of rendering services; and (25) Comply with provider audits authorized by State and federal law to ensure compliance with Program requirements. B. Enrollment Effective Date. (1) Unless a provider is enrolled under the provisions of §B(2) of this regulation, the effective date of a provider’s enrollment is the date the Program completes all screenings required by State and federal law, which may include a site visit, following the Program’s receipt of the provider’s submission of a complete application with all required supporting documents. (2) If an out-of-State emergency transportation services or emergency services provider meets provider enrollment requirements, the enrollment effective date is the date the provider renders the emergency services. C. A provider may not seek payment from more than one State agency for the same service. D. If the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or preauthorized, the provider may not seek payment for that service from the participant. E. If the Program denies payment for covered services for any reason, the provider may not seek payment for the denied service from the participant. F. The Program may pay for a covered service rendered by a provider to a participant under any of the following circumstances: (1) The provider charges for nonparticipants who receive the same service by: (a) Charging the individual in full for services rendered; (b) Using a sliding fee scale based on the individual's income; (c) Waiving all or part of the fee for a specific individual; or (d) Agreeing to accept what a third party pays as payment in full, whether or not the provider bills individuals who lack this coverage; (2) The State, using its own funds, pays for services rendered to a targeted group of nonparticipants, and the provider charges nontargeted users of the services; (3) The provider bills all individuals with third party coverage, whether or not the provider bills individuals who lack this coverage; (4) The service is offered by or through the State agency which administers the program of services authorized under Title V of the Social Security Act; or (5) The service is offered to a handicapped child receiving services under the Education for the Handicapped Act (EHA) under an individualized education plan (IEP). G. The following types of providers shall comply with the requirements of 42 CFR Part 489, Subpart I, Advance Directives: (1) Acute hospitals under COMAR 10.09.92; (2) Chronic hospitals under COMAR 10.09.93; (3) Special pediatric hospitals under COMAR 10.09.94; (4) Special psychiatric hospitals under COMAR 10.09.95; (5) Nursing facilities under COMAR 10.09.10 and COMAR 10.09.11; (6) Home health agencies under COMAR 10.09.04; (7) Personal care case monitors under COMAR 10.09.20; (8) Model waiver nursing services providers under COMAR 10.09.27; and (9) Hospices under COMAR 10.09.35. H. For services that are funded under the Substance Abuse and Mental Health Services Administration and related federal funding sources, specifically for providers that bill the public behavioral health system for specialty mental health services described in COMAR 10.09.59 and community-based substance use disorder services described in COMAR 10.09.80 shall provide data elements per Federal requirements set forth in 42 U.S. Code §300x–9 and 42 USC 300x-35, to the State in the frequency required by the Department. I. State Department of Assessments and Taxation (SDAT) Identification Number. A provider shall obtain an SDAT identification number that: (1) Identifies their organizational structure as either: (a) An individual provider, classified with a prefix of the letter L; or (b) A business entity; and (2) Is maintained in good standing as described in COMAR 18.04.03.01. J. Each provider practice location shall: (1) Be individually enrolled with the Program; (2) Have an individualized provider agreement as described under §A(6) of this regulation; (3) Maintain a unique NPI number as described under §K of this regulation. K. National Provider Identification (NPI) Number. (1) Unless specifically excepted under §K(2) of this regulation, each provider shall maintain a unique NPI number that: (a) Correctly classifies the provider as either: (i) An individual provider with a Type 1 NPI number; or (ii) An organizational provider with a Type 2 NPI number; and (b) For Type 2 organizational providers, is individualized to a specific service or practice location. (2) The following enrollment types are exempt from the individualized Type 2 NPI number requirement in §K(1)(b) of this regulation: (a) Skilled nursing facility therapy groups with an affiliated nursing facility provider; (b) Pharmacies with an affiliated durable medical equipment and disposable medical supplies provider; and (c) Hospitals. L. Providers may not request or require that a participant waive, revoke, or otherwise forgo Medicaid coverage as a condition for receiving covered services. #### Regulation .03-1 Conditions for Participation — Home and Community-Based Settings. *COMAR 10.09.36.03-1* A. Providers of services under COMAR 10.09.84 shall comply with the provisions of §§D—F of this regulation and 42 CFR 441.301(c)(4). B. Effective January 1, 2018, to be enrolled as a provider of services authorized under §§1915(c) or 1915(i) of the Social Security Act, the provider shall comply with the provisions of §§D—F of this regulation and 42 CFR 441.301(c)(4). C. Providers of services authorized under §§1915(c) or 1915(i) of the Social Security Act that are enrolled Maryland Medicaid providers before January 1, 2018, shall comply with the provisions of §§D—F of this regulation on or before March 17, 2022. D. The setting in which services are provided shall: (1) Be integrated in and support full access to the greater community for individuals receiving Medicaid home and community-based services to the same degree of access as individuals not receiving Medicaid home and community-based services; (2) Be selected by the individual from among setting options, including nondisability specific settings; (3) Be identified and documented in the person-centered service plan and is based on the individual’s needs and preferences; (4) Ensure an individual’s rights of: (a) Privacy; (b) Dignity and respect; and (c) Freedom from coercion and restraint; (5) Optimize, but not regiment, individual initiative, autonomy, and independence in making life choices, including but not limited to: (a) Daily activities; (b) Physical environment; and (c) With whom to interact; and (6) Facilitate individual choice regarding services and supports, and who provides them. E. In addition to the provisions of §D of this regulation, provider-owned or controlled settings shall meet the following conditions: (1) The unit or dwelling is a specific physical place that can be owned, rented, or occupied under a legally enforceable agreement by the individual receiving services and the individual has, at a minimum, the same responsibilities and protections from eviction that tenants have under the landlord tenant law of the State, county, city, or other designated entity; (2) Each individual has privacy in their sleeping or living unit, as evidenced by the following: (a) Units have entrance doors lockable by the individual, with only appropriate staff having keys to doors; (b) Individuals sharing units have a choice of roommates; and (c) Individuals have the freedom to furnish and decorate their sleeping or living units within the lease or other agreement; (3) Individuals have the freedom and support to control their own schedules and activities; (4) Individuals have access to food at any time; (5) Individuals are able to have visitors of their choosing at any time; and (6) The setting is physically accessible to the individual. F. Any modification of the conditions under §§D and E of this regulation shall be supported by a specific assessed need and justified in the person-centered services plan in accordance with 42 CFR 441.301(c)(2)(xiii). #### Regulation .03-2 Conditions for Participation — Data Management Systems and Electronic Visit Verification. *COMAR 10.09.36.03-2* A. This regulation establishes standards for providers using Data Management systems. B. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Terms Defined. (a) “Data management system” means a health information technology solution used by the Maryland Department of Health (Department), its agents, providers, and Program participants that stores provider or participant protected health information (PHI) or personally identifiable information (PII) and related business processes. (b) “Electronic visit verification (EVV)” means an electronic service entry method used to record service details, including but not limited to service type, provider and participant information, date of service, service delivery location, and beginning and ending times of service that meets the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines. (c) Electronic visit verification (EVV) services means services that are: (i) Covered Medicaid services, according to the respective authority, including but not limited to the Medicaid State Plan, a Medicaid waiver program, or regulations; and (ii) Required to be electronically recorded in the Department’s EVV system or approved financial management and counseling services contractors’ EVV solutions pursuant to 42 U.S.C. §1396b(l) and other State and federal laws, regulations, or guidance except in circumstances when the services, provided under the agency, traditional, or self-directed delivery model, are provided by a live-in caregiver or worker and exempted by the Department, or otherwise exempted by the Department and the participant elects to forego the electronic process. (d) “Financial management and counseling services (FMCS) contractors” means agencies that provide financial management and counseling services to support individuals who choose the self-direction delivery model. (e) “Live-in caregiver” means a paid personal caregiver who permanently, or for an extended period of time approved by the Department, resides in the same residence as the Medicaid participant for whom they are providing services and supports. (f) “Preauthorized” means approved by the Department or its designee before services are rendered. (g) “Worker” means an individual, who may be referred to as a caregiver, who is employed by or contracts with a provider or self-directing participant. C. Requirements for Using Data Management Systems. Providers shall: (1) Register and credential all system users in the manner specified by the Department with valid and accurate information; (2) Properly train all workers registered as system users on proper protocols for conducting system activities, including: (a) Accurate entry of information into the system; (b) Proper use of hardware and equipment required to use the system; (c) EVV, including but not limited to recording and modifying billing entries, participant and provider information, or other records, in accordance with the policies and procedures issued by the Department, unless otherwise exempted by the Department; and (d) Protection of protected health information in compliance with State and federal law, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA); (3) Comply with the laws and regulations concerning the privacy and security of protected health information under State and federal law, including HIPAA; and (4) Ensure that any provider-owned systems and devices responsible for sending, retrieving, or storing data from a State-operated data management system comply with all Department, State and federal regulations, policies, and procedures regarding information technology privacy and security. D. Requirements for EVV Use. (1) Agency providers and workers shall use the EVV method and data management system approved by the Department, unless otherwise exempted by the Department, to: (a) Meet the requirements of the 21st Century Cures Act, codified at 42 U.S.C. §1396b(l) and other State or federal guidelines; and (b) Submit claims. (2) The Department shall reimburse for EVV services if the service is: (a) Electronically recorded through the EVV method and data management system approved by the Department in accordance with Department regulations, policies, and procedures; (b) Recorded using a manual or alternate electronic timekeeping process and data management system approved by the Department in accordance with Department regulations, policies, and procedures when the live-in caregiver exemption is applicable and elected; (c) Preauthorized in the manner designated by the Department for the service type; (d) Directly provided to the participant in-person, unless otherwise authorized by the Department; and (e) Delivered in accordance with all applicable Department regulations, policies, and procedures for the service type. (3) The Program does not cover services, even those exempted from EVV, provided: (a) During periods of participant ineligibility; (b) During time periods that overlap with the worker’s time period for the same or another participant unless otherwise authorized by the appropriate program authority for the service type; or (c) During time periods that overlap with the same or another worker’s time period for the same participant unless otherwise authorized by the appropriate program authority for the service type. #### Regulation .04 Payment Procedures. *COMAR 10.09.36.04* A. The provider shall submit the request for payment of services rendered according to procedures established by the Department and in the format designated by the Department. B. The Department reserves the right to return to the provider, before payment, all claims not properly signed, completed, and accompanied by properly completed forms required by the Department. C. The Program will make no direct payment to recipients. D. All payments are contingent upon a provider’s full compliance with the requirements of its enrollment and applicable conditions of participation. E. Unless the service is free to the general public, the provider shall charge the Program its customary charge to the general public for similar services. F. Unless otherwise excepted, the provider shall be paid the lesser of: (1) The provider’s customary charge unless the service is free to individuals not covered by the Program; or (2) The Department’s applicable rate. G. Unless otherwise excepted, if a service is free to individuals not covered by the Program: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §F of this regulation; and (2) The provider's reimbursement is not limited to the provider's customary charge. H. Providers may not bill the Department, the Program, or participants for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Covered professional services rendered by: (a) Mail; (b) Email; or (c) Fax; or (4) Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. I. Unless otherwise excepted, payments on Medicare claims are authorized, if: (1) Services are covered by the Medicare Program; (2) The provider accepts Medicare assignments; (3) Medicare makes direct payment to the provider; (4) Medicare has determined that services were medically justified; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. J. Unless otherwise provided by regulation, supplemental payments on Medicare claims are made subject to the following provisions: (1) Deductible insurance will be paid in full; (2) Beginning with August 1, 2010 dates of service and subject to the limitations of the State budget, coinsurance shall be paid: (a) In full for the following: (i) Mental health services; (ii) CPT codes that are priced by report; (iii) Claims for anesthesia services; (iv) Claims from a federally qualified health center; and (v) HCPCS codes beginning with A through W; and (b) For all other claims, at the lesser of: (i) 100 percent of the coinsurance amount; or (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare are payable according to §F of this regulation. K. An individual or entity who is employed by or under contract to any group provider, clinic, or hospital may not bill for any service for which reimbursement is sought by the group provider, clinic, or hospital. #### Regulation .05 Cost Reporting. *COMAR 10.09.36.05* A. Providers who are reimbursed on the basis of cost reports shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 3 months after the end of the provider's fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. B. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. C. An extension shall be granted upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable. D. Availability of Records. (1) The provider shall keep all records available for inspection or audit by the Department or the Department's designee at any reasonable time during normal business hours. (2) Documentation of Costs. (a) Upon request by the Department or the Department's designee, the provider shall make documentation of costs available during the course of verification. (b) The provider shall have 30 days from the date of the request to provide this documentation. (c) Costs for which documentation is not provided within the 30 days shall be considered not allowable. (3) Upon written demonstration by the provider of good cause, the Department may grant, in writing, an extension of time to provide the requested documentation. (4) Records shall be retained for 6 years after the month in which the cost report to which the materials apply is filed with the Department or the Department's designee. #### Regulation .06 Billing Time Limitations. *COMAR 10.09.36.06* A. Definition. (1) In this regulation, the following term has the meaning indicated. (2) Term Defined. “Received” means: (a) The Program taking delivery of a claim after the Program signs a certified mail, return receipt requested parcel from the United States Postal Service; or (b) The claim is reported on the provider’s remittance advice. B. Unless specified in Regulation .03A(1) of this chapter, the following apply: (1) The Department may not reimburse the claims received by the Program for payment more than 12 months after the date of service. (2) Medicare Claims. For any claim initially submitted to Medicare and for which services have been: (a) Approved, requests for reimbursement shall be submitted and received by the Program within 12 months of the date of service or 120 days from the Medicare remittance date, as shown on the Explanation of Medicare Benefits, whichever is later; and (b) Denied, requests for reimbursement shall be submitted and received by the Program within 12 months of the date of service or 120 days from the Medicare remittance date, as shown on the Explanation of Medicare Benefits, whichever is later. (3) Fee for Service Claims. (a) Fee for service claims shall be submitted and received by the Program within 12 months of: (i) The date of service; (ii) The date of discharge, if the service was a hospital inpatient service; or (iii) The month of service, if the service was provided in a nursing or rehabilitation facility or is a hospice service. (b) The Program shall only pay claims for services provided on different dates and submitted on a single claim if the single claim form is received by the Program within 12 months of the earliest date of service. (c) The Program shall only pay a claim that was initially rejected, denied, or not acted upon within reasonable promptness after being received by the Program, if the claim is: (i) Complete according to Program billing instructions and the 837 HIPAA compliant and companion guidelines; (ii) Resubmitted; and (iii) Received by the Program within the later of 12 months from the date of service or 60 days from the date last received by the Program or last rejected by the Program. (4) A claim for services provided on different dates and submitted on a single form shall be paid only if it is received by the Program within 12 months of the earliest date of service. (5) The Program shall only pay a claim that was initially rejected, denied, or not acted upon within reasonable promptness after being received by the Program, if the claim is: (a) Complete according to Program billing instructions and the 837 HIPAA compliant and companion guidelines; (b) Resubmitted; and (c) Received by the Program within the later of: (i) 12 months from the date of service; or (ii) 60 days from the date last received by the Program or last rejected by the Program. (6) Claims submitted after the time limitations because of a retroactive eligibility determination shall be considered for payment if received by the Program within 12 months of the date on which eligibility was determined. (7) Late Charge Billing. (a) The Program shall only accept additional or supplemental claims that were not included with a larger primary claim paid by the Program if all of the additional or supplemental claims are: (i) Submitted together; (ii) Submitted in accordance with the requirements of §B(3) of this regulation; and (iii) Received within 60 days of the original paid claim date. (b) The Program shall only accept one additional or supplemental claim under §B(7)(a) of this regulation for each: (i) Date of service; (ii) Date of discharge; or (iii) Month of service billed. (8) Adjustment Requests. Requests by providers to adjust information in claims already paid, including but not limited to changing the days billed, the amount charged, the units of service, or the rate of the service, shall be submitted to the Program in accordance with §B(3) and (5) of this regulation. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.36.07* A. If the participant has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, covered services, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Program. The Program shall pay the difference between what was paid by the insurance carrier and the Program's maximum fees. Total payment cannot exceed the Program's maximum fee. The provider shall submit a copy of the insurance carrier's notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. C. The Department may conduct provider audits as authorized by State and federal law to ensure compliance with Program requirements. D. For audits commencing on or after July 1, 2004, if the provider fails to reimburse the Department in accordance with §§A and B of this regulation, the provider shall be responsible for reimbursing the Department for the amount of the overpayment and any audit costs incurred by the Department in seeking recovery of the overpayment. E. An audit is considered to have commenced upon the initial written notification by the Department or the Department's agent to the provider. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.36.08* A. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider or related party of the provider has failed to comply with applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the Program; (2) Withholding of payment by the Program; (3) Recovery of an overpayment; (4) Removal from the Program; and (5) Disqualification from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. B. If the Secretary of Health and Human Services suspends or removes a provider from participation in Medicare, the Department shall take similar action. C. The Department may report to the federal Secretary of Health and Human services any providers removed from participation with the Program for failure to comply with applicable federal or State laws and regulations in accordance with 42 CFR §455.416. D. The Department shall give the provider reasonable notice of its intention to impose sanctions. In the written notice, the Department shall establish the effective date and the reasons for the proposed action, and advise the provider of the right to appeal. E. A provider who voluntarily withdraws from the Program, or is removed or suspended from the Program according to this regulation, shall notify participants, before rendering additional services, that the provider no longer honors Medical Assistance cards. #### Regulation .09 Filing Appeal. *COMAR 10.09.36.09* A. Source of Appeals. (1) A provider may file an appeal from a proposed Program action to: (a) Suspend the provider from the Program; (b) Withhold payment by the Program; (c) Recover an overpayment; (d) Remove the provider from the Program; or (e) Disqualify the provider from future participation in the Program, either as a provider or as a person providing services for which Program payment will be claimed. (2) A provider shall submit an appeal according to: (a) COMAR 10.01.03; (b) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (c) Health-General Article, §§2-201—2-207, Annotated Code of Maryland; and (d) COMAR 28.02.01. (3) A provider may not file an appeal from a Program action to terminate the provider when that action is the result of either: (a) Termination of the provider or an owner by the federal government or another state Medicaid agency pursuant to 42 CFR §445.416; or (b) Suspension or termination of the provider’s license or certificate by their respective licensing or certification authority. B. Request for a Hearing. (1) An appeal of a proposed Program action shall be filed in writing with the Program within 30 days of the date of the notice of the proposed Program action. The Program shall make reasonable accommodation if a provider cannot submit a written request because of a disability. (2) The Program shall immediately forward a written appeal request to the Office of Administrative Hearings. (3) The Office of Administrative Hearings shall: (a) Promptly acknowledge any appeal; and (b) Notify the provider and the Program in writing of the date, time, and place of the hearing. C. Effective Date. The proposed Program action shall be effective on: (1) The date of the proposed Program action notice if the Program: (a) Determines that the provider poses an imminent threat to public health, safety, or welfare that requires emergency action; and (b) Notifies the provider of this determination in the proposed Program action notice; (2) The date specified in the proposed Program action notice if the provider: (a) Does not request a hearing within 30 days of the date of the notice of the proposed Program action; or (b) Withdraws in writing or abandons a request for a hearing before the effective date of the proposed Program action; (3) The first payment date following the date of the Program action notice if the Program action involves withholding payment to the provider because the Program discovered an overpayment to the provider; (4) The date the administrative law judge renders a decision in favor of the Program if the provider: (a) Fails to timely file exceptions to the administrative law judge's decision with the Secretary pursuant to §D of this regulation; or (b) Withdraws in writing or abandons a request for an exceptions hearing before the date of the exceptions hearing; or (5) The date the Secretary renders a decision in favor of the Program pursuant to COMAR 10.01.03 if any party files exceptions with the Secretary in accordance with §E(1) of this regulation. D. A Program determination to suspend payments due to a credible allegation of fraud shall be effective immediately unless the Department determines, consistent with 42 CFR §455.23, that a good cause exception to immediate suspension exists. E. Exceptions and Outcomes. (1) A party may seek additional administrative review of the administrative law judge's decision by filing in writing exceptions with the Secretary within 30 days of the date of the administrative law judge's decision pursuant to COMAR 10.01.03. (2) If the Secretary's decision is favorable to the Program, the Program may: (a) Immediately implement the proposed Program action; and (b) Institute recovery procedures against the provider to recoup the cost of any payments made to the provider to the extent the payments were made solely because the provider was permitted to continue to submit claims to the Department because of §C(5) of this regulation. (3) If the proposed Program action was effective on the date of the notice as provided for in §B(1) of this regulation, the Program shall authorize corrected payments or relief retroactive to the date of the notice if: (a) The Secretary's decision is favorable to the provider; or (b) The Program grants the provider the relief the provider requests before the Secretary's decision. F. Further Appeals. The provider may seek additional administrative review of the Secretary's decision as provided in Health-General Article, §§2-206 and 2-207, Annotated Code of Maryland, and subsequent judicial review as provided in State Government Article, §10-215, Annotated Code of Maryland. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.36.10* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. #### Regulation .11 Provider Rights. *COMAR 10.09.36.11* Providers participating in the Program shall have the right to: A. Be treated professionally with courtesy, dignity, and respect regardless of the individual's: (1) Race; (2) Color; (3) Religion; (4) Gender; (5) Sexual orientation; (6) National origin; (7) Political affiliation; (8) Disability; (9) Marital status; (10) Age; or (11) Union affiliation; B. File a complaint with the appropriate State agency when the provider believes that the provider has been discriminated against because of: (1) Race; (2) Color; (3) Religion; (4) Gender; (5) Sexual orientation; (6) National origin; (7) Political affiliation; (8) Disability; (9) Marital status; (10) Age; or (11) Union affiliation; C. Have the information in the provider's Program file kept confidential except as otherwise stated by State or federal law; D. Be reimbursed for covered services provided to Program participants; and E. Participate in an impartial grievance and appeals process as outlined in COMAR 10.09.36.09. ### Chapter 37 — Family Planning Program Eligibility **Authority:** Health-General Article, §§2-104(b), 15-103(a), and 15-140, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.15 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686) **Administrative History:** Chapter revised effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .02B amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .09 amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .11 amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Chapter revised effective January 13, 2020 (47:1 Md. R. 12) **Administrative History:** Regulation .03A amended effective June 9, 2025 (52:11 Md. R. 532) **Administrative History:** Regulation .03-1 adopted effective February 22, 2021 (48:4 Md. R. 176) #### Regulation .01 Purpose and Scope. *COMAR 10.09.37.01* This chapter governs the determination of eligibility for the Family Planning Program. #### Regulation .02 Definitions. *COMAR 10.09.37.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Applicant. (a) “Applicant” means an individual whose written, signed application for the Family Planning Program has been submitted to the Department but has not received final action. (b) “Applicant” includes a non-pregnant individual whose application is submitted through an authorized representative. (2) “Application” means the filing of a written and signed application form for the Family Planning Program at the Department or its designee. (3) “Application date” means the date on which a written, signed application is received by the Department. (4) “Application form” means the form designated by the Department to be completed, signed, and submitted to the Department, or its designee, as an official application for the Family Planning Program. (5) “Authorized representative” means a spouse, legal guardian, parent, individual with power of attorney, relative or other individual designated in writing to the Department, authorized concerning the applicant’s or participant’s eligibility under this chapter to: (a) Act on an applicant’s or participant’s behalf; and (b) Assist with the application or redetermination process and in other communication with the Department. (6) “Continuing eligibility” means a participant’s eligibility for a subsequent certification period after the current certification period, based on the Department’s redetermination of eligibility with respect to an individual who is enrolled in Family Planning on the application date. (7) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (8) “Determination” means a decision regarding an applicant's eligibility for the Family Planning Program. (9) “Family Planning Program” means the program established in Health–General Article, §15-103 et seq., Annotated Code of Maryland to provide services related to contraceptive care to individuals who meet the eligibility requirements specified in Regulation .03 of this chapter. (10) “Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2). (11) “Household” means a MAGI household unit as set forth in COMAR 10.09.24.06-1. (12) “Income” has the meaning stated in COMAR 10.09.24.02B. (13) “Inmate in a public institution” has the meaning stated in COMAR 10.09.24.05-5. (14) “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility under the Affordable Care Act. (15) “MAGI coverage groups” has the meaning stated in COMAR 10.09.24.03A. (16) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq. (17) “Participant” means an individual who is determined eligible for the Family Planning Program. (18) Public Institution. (a) “Public institution” means an institution that is the responsibility of a governmental unit or over which a governmental unit exercises administrative control. (b) “Public institution” does not mean a medical institution, a skilled nursing facility, or a publicly operated community residence that serves no more than 16 residents. (19) “Redetermination” means a determination regarding the eligibility of a participant. #### Regulation .03 Eligibility for Family Planning Program Coverage. *COMAR 10.09.37.03* A. In order to be determined eligible for benefits under the Family Planning Program, an applicant: (1) Shall: (a) Have a household income that does not exceed 250 percent of the federal poverty level; and (b) Meet the following requirements: (i) Citizenship requirements in COMAR 10.09.24.05; (ii) Identity requirements in COMAR 10.09.24.05-1AF and H; and (iii) Residency requirements in COMAR 10.09.24.05-3. (2) May not be: (a) Pregnant; (b) Determined eligible for another Medical Assistance Program; or (c) An incarcerated inmate in a public institution as defined in COMAR 10.09.24.05-5A. B. An applicant whose income does not exceed 250 percent of the federal poverty level and is determined eligible for pregnancy or postpartum coverage under COMAR 10.09.24 shall be: (1) Enrolled for 1 year without filing a separate application after pregnancy related period of eligibility ends; and (2) Redetermined for eligibility based on the criteria in §A of this regulation. #### Regulation .03-1 Family Planning Program Presumptive Eligibility. *COMAR 10.09.37.03-1* A. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Terms Defined. (a) “Applicant” means an individual who has applied for presumptive eligibility at a participating family planning clinic. (b) “Application” means the presumptive eligibility application. (c) “Authorized representative” has the meaning stated in COMAR 10.01.04.01. (d) “Determination” means a decision regarding an applicant’s presumptive eligibility. (e) “Family planning clinic” means an entity that: (i) Provides family planning services under a written agreement with the Maryland Department of Health, Prevention and Health Promotion Administration; and (ii) Is approved to perform family planning presumptive eligibility determinations. (f) “Former foster care” means an individual who: (i) Is younger than 26 years old; (ii) Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and (iii) Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance, upon attaining age 18 and leaving out-of-home placement or upon attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B. (g) “Income” means property or a service received by an individual in cash or in-kind, which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. (h) “Maryland Family Planning Program Delegate Service Site” means an entity that provides family planning services under a written agreement with the Department. (i) “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals. (j) “Presumptive eligibility” means temporary eligibility for Family Planning Program services as determined by family planning clinics in accordance with this regulation. B. Requirements. (1) A family planning clinic qualified to make presumptive eligibility decisions shall: (a) Participate as a Medical Assistance Program provider in good standing; and (b) Sign an agreement prepared by the Department. (2) The agreement under §B(1)(b) of this regulation shall require that the family planning clinic: (a) Comply with Departmental policies and procedures supplied by the Department at the time of application and training; (b) Meet accuracy and timeliness standards established by the Department; (c) Submit a list to the Department of family planning clinic employees who will attend presumptive eligibility training developed by the Department; (d) Prohibit employees who have not attended required trainings from making presumptive eligibility decisions; and (e) Report all requested information on a form designated by the Department. (3) Before assisting an applicant in filing a presumptive eligibility application, the family planning clinic employee shall: (a) Check the Department’s eligibility verification system to make sure the individual is not actively enrolled in the Medical Assistance Program; (b) Provide information concerning the full Medical Assistance application process to the individual applying for presumptive eligibility and assist or refer the applicant to an individual who can assist the applicant in completing a full Medical Assistance application; and (c) Determine that the applicant: (i) Has not had a prior family planning presumptive eligibility period within the last 12 months; (ii) Is not pregnant; or (iii) Is not actively enrolled in the Medical Assistance Program. (4) The family planning clinic employee shall fill out the presumptive eligibility application based on information supplied by the applicant. (5) The family planning clinic employee shall make a presumptive eligibility decision and submit the presumptive eligibility application by applying §D of this regulation and the following information obtained pursuant to §C of this regulation: (a) Residency; (b) Citizenship; (c) Family size and composition; and (d) Gross family income. (6) The family planning clinic employee shall inform the individual in writing of the family planning clinic’s presumptive eligibility decision, which shall include an explanation of the presumptive eligibility period. (7) The family planning clinic shall submit the presumptive eligibility application to the Department on the date of application completion to allow the individual to have temporary Medical Assistance coverage. (8) The family planning clinic shall: (a) Keep all written and signed presumptive eligibility applications on file for 6 years; and (b) Make the file available to the Department upon request. C. Presumptive Eligibility Criteria. (1) An individual shall apply for presumptive eligibility through a participating family planning clinic. (2) An individual who applies for presumptive eligibility shall attest to: (a) The citizenship requirements in COMAR 10.09.24.05; (b) The residency requirements in COMAR 10.09.24.05-3; (c) The individual’s pregnancy status; (d) The individual’s family size; and (e) The gross monthly income of the individual’s household. D. Presumptive eligibility may be established for individuals who meet the Family Planning Program eligibility requirements in Regulation .03 of this chapter. E. Limitations. Presumptive eligibility may not be granted to an individual who: (1) Is pregnant; (2) Is currently enrolled in the Medical Assistance Program; (3) Had a prior presumptive eligibility period during the last 12 months; (4) Does not meet the income requirements stated in Regulation .03 of this chapter ; (5) Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or (6) Does not meet the citizenship requirements stated in COMAR 10.09.24.05. F. Coverage Span. (1) Presumptive eligibility begins on the day the presumptive eligibility worker determines the individual is presumptively eligible. (2) Presumptive eligibility ends on the earlier of: (a) The day the individual is determined eligible for Medical Assistance; or (b) The last day of the month following the month in which the family planning clinic determined presumptive eligibility, if an individual: (i) Is found ineligible for Medical Assistance; or (ii) Failed to apply for Medical Assistance. G. Presumptive Eligibility Appeal Rights. An individual or an organization does not have appeal rights for presumptive eligibility determinations. #### Regulation .04 Application. *COMAR 10.09.37.04* For individuals not described in .03B of this chapter, application for Family Planning Program services will be conducted pursuant to the provisions of COMAR 10.09.24.04. #### Regulation .05 Consideration of Income. *COMAR 10.09.37.05* Determination of an applicant’s income for purposes of the Family Planning Program shall be determined under the household provisions of COMAR 10.09.24.06-1 and the income provisions applicable to MAGI household units of COMAR 10.09.24.07. #### Regulation .06 Determining Financial Eligibility. *COMAR 10.09.37.06* An applicant is financially eligible for the Family Planning Program if the applicant's MAGI household income as determined under COMAR 10.09.24.06-1 and .07 does not exceed 250 percent of the federal poverty level. #### Regulation .07 Certification Periods. *COMAR 10.09.37.07* A. For a participant, certification for initial eligibility begins not sooner than the first day of the month of application. B. A participant’s eligibility under Regulation .03 of this chapter will end as of the: (1) End of a 12 month certification period; (2) Date eligibility is determined in another Medicaid coverage group; (3) Date the participant ceases to qualify under the requirements of Regulation .03A of this chapter; (4) Beginning of the month in which the participant is enrolled in Medicare; or (5) Date a participant becomes an inmate in a public institution. #### Regulation .08 Covered Services. *COMAR 10.09.37.08* A Family Planning Program recipient shall be entitled to services as stated in COMAR 10.09.58. #### Regulation .09 Post–Eligibility Requirements. *COMAR 10.09.37.09* Post-eligibility requirements for the Family Planning Program are set forth at COMAR 10.09.24.12. #### Regulation .10 Hearings. *COMAR 10.09.37.10* The procedures for the Program granting a hearing to an applicant or a recipient and the status of benefits pending a hearing are set forth in COMAR 10.01.04. #### Regulation .11 Fraud and Abuse. *COMAR 10.09.37.11* The requirements relating to fraud and abuse under COMAR 10.09.24.14 and COMAR 10.09.24.14-1 shall apply to this chapter. #### Regulation .12 Adjustments and Recoveries. *COMAR 10.09.37.12* The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, excluding COMAR 10.09.24.15A(2)—(3) and COMAR 10.09.24.15A(3), shall apply to this chapter. #### Regulation .13 Interpretive Regulation. *COMAR 10.09.37.13* State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 38 — Healthy Start Program **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1989 (16:12 Md. R. 1337) **Administrative History:** Regulations .01—.05 amended as an emergency provision effective August 1, 1989 (16:16 Md. R. 1745); amended permanently effective November 29, 1989 (16:22 Md. R. 2364) **Administrative History:** Regulation .01B amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .02 amended effective July 20, 1992 (19:14 Md. R. 1283); November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .02G adopted effective September 3, 1990 (17:17 Md. R. 2080) **Administrative History:** Regulation .03 amended effective November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .03A, E amended effective June 2, 1997 (24:11 Md. R. 794) **Administrative History:** Regulation .03D, E amended effective July 20, 1992 (19:14 Md. R. 1283) **Administrative History:** Regulation .03F adopted effective September 3, 1990 (17:17 Md. R. 2080) **Administrative History:** Regulation .04 amended effective July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .04F adopted effective September 3, 1990 (17:17 Md. R. 2080) **Administrative History:** Regulation .04G, H adopted effective July 20, 1992 (19:14 Md. R. 1283) **Administrative History:** Regulation .05 amended effective June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .05B amended, C adopted effective July 20, 1992 (19:14 Md. R. 1283) **Administrative History:** Regulation .06B amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004) **Administrative History:** Regulation .06B amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004) **Administrative History:** Regulation .06C amended effective September 3, 1990 (17:17 Md. R. 2080); July 20, 1992 (19:14 Md. R. 1283); June 2, 1997 (24:11 Md. R. 794); November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulations .07—.10 repealed and new Regulations .07—.10 adopted effective June 2, 1997 (24:11 Md. R. 794) **Administrative History:** Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .02D repealed effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .03D amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .03E repealed effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .04D repealed effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .06C amended effective December 27, 2010 (37:26 Md. R. 1787); February 27, 2017 (44:4 Md. R. 252) #### Regulation .01 Definitions. *COMAR 10.09.38.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Dietitian or nutritionist” means an individual who: (a) Meets the licensing requirements in Regulation .02D of this chapter; (b) Meets the conditions of participation in Regulation .03A and D of this chapter; and (c) Has a provider agreement with the Department as a Program provider of dietary and nutrition services. (3) “Enriched maternity service” means direct counseling, educational, case coordination, and referral services provided to a pregnant or postpartum recipient by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife during the prenatal or postpartum visit. (4) “Family support center” means a community-based and operated center which provides parenting education, health education, child development assessment services, education and job skill development services, and social support services to families. (5) “Healthy Start High-Risk Nutrition Instrument” means the form designated by the Department for the purpose of identifying pregnant participants in need of high-risk nutrition counseling services. (6) “Healthy Start Prenatal Risk Assessment Instrument” means the form furnished by the Department to the provider for the purposes of documenting the results of the prenatal risk assessment and developing the participant's plan of care. (7) “Healthy Start Program” means a program designed to identify and address medical, nutritional, and psychosocial predictors of poor birth outcomes and poor child health by providing enhanced prenatal and postpartum services to pregnant and postpartum recipients. (8) “High-risk nutrition counseling services” means educational services provided to nutritionally high-risk pregnant participants by a dietitian or nutritionist. (9) “Local health department” means the local agency responsible for ensuring the availability of basic public health services in each local jurisdiction, and for administering and enforcing certain State and local health laws and regulations. (10) “Maternal and Child Health Services Block Grant” means funds allotted by the federal government under Title V of the Social Security Act. (11) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (12) “Nurse” means an individual who is licensed as a registered nurse in the state in which services are provided. (13) “Nurse midwife” means an individual who: (a) Meets the licensing requirements of Regulation .02A of this chapter; (b) Meets the conditions of participation in Regulation .03A—C of this chapter; and (c) Has a provider agreement with the Department as a Program provider of nurse midwife services. (14) “Participant” means a pregnant or postpartum recipient who: (a) Enters the Healthy Start Program during a medically verified pregnancy, or up to 60 days after delivery; (b) May continue in the program receiving postpartum family planning services up to 60 days after the delivery; and (c) Elects to receive the services available under these regulations. (15) “Physician” means a doctor of medicine or osteopathy who: (a) Is licensed to practice medicine in the state in which services are provided; (b) Has a provider agreement with the Department as a Program provider of physician services; and (c) Meets the conditions of participation in Regulation .03A—C of this chapter. (16) “Program” means the Maryland Medical Assistance Program. (17) “Provider” means a qualified provider of services under the Healthy Start Program who meets the conditions of participation in Regulation .03 of this chapter. (18) “Provider agreement” means a contract between the Department and the provider. (19) “Recipient” means an individual who is certified for and is receiving Medical Assistance benefits. (20) “Risk assessment—plan of care” means a package of services provided to a pregnant participant by or under the supervision of a physician or nurse midwife in conjunction with the clinical services provided by the physician or nurse midwife, to include: (a) A comprehensive risk assessment appraising the participant's medical history and current health, nutritional, psychological, and social status; and (b) An individualized plan of care developed by the provider in consultation with the participant. (21) “Social worker” means a person who is licensed as a social worker in the state in which services are provided. (22) “Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)” means the federally funded program authorized under an amendment to the Child Nutrition Act of 1966 (PL 94-105) to provide supplemental foods and nutrition education to pregnant and postpartum women, infants, and young children from families with low incomes who are at risk by reason of inadequate nutrition or health care. (23) “Tertiary care maternity center” means a facility with all necessary equipment and personnel specifically trained to care for high-risk obstetrical patients and with the capability to perform all necessary tests and obstetrical procedures 24 hours a day. #### Regulation .02 Licensing Requirements. *COMAR 10.09.38.02* A. A certified nurse midwife providing Healthy Start services shall be: (1) Licensed as a registered nurse in the state in which services are provided; (2) Certified as a nurse midwife by the American College of Nurse-Midwives; and (3) In compliance with requirements to practice nurse midwifery in the state in which services are provided. B. Physicians providing Healthy Start services shall be licensed and legally authorized to practice medicine in the state in which the services are provided. C. Dietitians or nutritionists providing Healthy Start Program services shall be licensed in the state in which the services are provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.38.03* A. General requirements for participation in the Medical Assistance Program are that providers shall: (1) Meet the licensure requirements in Regulation .02 of this chapter, and verify the licenses and credentials of all professionals employed by the provider; (2) Apply for participation in the Program using an application form designated by the Department; (3) Be approved for participation by the Department; (4) Have a provider agreement with the Department in effect; (5) Be identified as a Program provider by issuance of an individual provider number; (6) Verify the eligibility of recipients; (7) Accept payment by the Program as payment in full for services rendered and make no additional charge to any person for the covered services specified in Regulation .04 of this chapter; (8) Provide services without discrimination on the basis of race, color, sex, national origin, marital status, physical or mental handicap; (9) Maintain adequate records concerning service provision for a minimum of 6 years and make them available, upon request, to the Department or its designee; (10) Not knowingly employ or contract with any person, partnership, or corporation which has been disqualified from the Program to provide or supply service to Medical Assistance recipients, unless prior written approval has been received from the Department; (11) Agree that claims rejected for payment due to late billing may not be billed to the participant; (12) Not place a restriction on the recipient's right to choose the provider; (13) Agree that if the Program denies payment or requests repayment on the basis that an otherwise covered service was not medically necessary or has not been preauthorized, the provider may not seek payment for that service from the participant; and (14) Be selected by the participant from among qualified providers. B. Specific requirements for providers of risk assessment-plan of care services are that providers shall: (1) Be physicians or nurse midwives; (2) Provide the covered services as specified in Regulation .04A of this chapter in conjunction with the pregnant participant's initial clinical prenatal visit or, otherwise, as early as possible in the pregnancy; (3) Maintain the participant's consolidated medical record; and (4) Agree to on-site visits by Department staff to monitor adherence to Regulation .04A of this chapter. C. Specific requirements for providers of enriched maternity services are that providers shall: (1) Be physicians or nurse midwives or be under the supervision of a physician or nurse midwife; (2) Provide the covered services as specified in Regulation .04B of this chapter in conjunction with each prenatal clinical visit of the pregnant participant and each postpartum clinical visit of the postpartum participant up to 60 days after the delivery; and (3) Agree to on-site visits by Department staff to monitor adherence to Regulation .04B of this chapter. D. Specific requirements for participation in the provision of high-risk nutrition counseling services are that providers shall: (1) Be a dietician or nutritionist as specified in Regulation .02C of this chapter; (2) Contact the recipient within 10 working days of the receipt of a referral from a local health department or private prenatal care provider, unless client-related extenuating circumstances are documented; and (3) Agree to on-site visits by Department staff to monitor adherence to Regulation .04C of this chapter. #### Regulation .04 Covered Services. *COMAR 10.09.38.04* Effective July 1, 2006, the Program shall reimburse for the following services: A. Risk Assessment — Plan of Care. (1) One unit of service is to be reimbursed for each pregnancy. (2) A risk assessment is an appraisal of the participant's medical history and current health, nutritional, psychological, and social status, as specified in the Healthy Start Risk Assessment Instrument. It results in the identification of problems having an impact on the outcome of the pregnancy and the subsequent health care status of the child. Based on the assessment, an appropriate plan of care is drafted and appropriate referrals are made. A copy of the completed Healthy Start Risk Assessment Instrument will be sent by the provider to the participant's local health department within 10 working days of the risk assessment. (3) A plan of care is a description of the services and resources required to meet the participant's needs identified through the risk assessment. An individual participant's plan of care: (a) Includes a description of the specific action steps necessary to address each identified need; (b) Matches the risk status of the participant to the appropriate intensity and breadth of care; (c) Describes the elements of care, provider or providers, and facilities to be utilized by the participant; (d) Is subject to modification as new information arises during the course of care, including information communicated from the provider of home-visiting services; (e) Is individualized and is developed in consultation with the participant; and (f) Encompasses the continuum of care from the prenatal period through postpartum. B. Enriched Maternity Service. A maximum of one unit of service is to be reimbursed in conjunction with each prenatal and postpartum clinical visit of the participant. The following components comprise enriched maternity service: (1) Prenatal and postpartum counseling and education. This component shall include, but not be limited to, the following topics: (a) The benefits and recommended schedule of prenatal visits, including routine laboratory and radiological services; (b) Danger signs of pre-term labor, including how to differentiate between normal and abnormal signs and symptoms related to pregnancy and what actions the individual should take; (c) Preparation for labor and delivery, including hospital registration procedures; (d) The risks of using prescription and over-the-counter medicines during pregnancy; (e) The risks of alcohol, tobacco, and controlled substance use; (f) The benefits of proper dental care; (g) The benefits of seat belt and infant car seat use; (h) The importance of postpartum care and continuing family planning services; and (i) Arrangements for pediatric care. (2) Nutrition education for pregnant and postpartum participants. This component shall include, but not be limited to, the following topics: (a) The relation of proper nutrition to a healthy pregnancy and to a successful pregnancy outcome; (b) Kinds and amounts of foods needed to meet nutritional requirements during pregnancy; (c) Appropriate weight gain during pregnancy, and components of gain; (d) Early decisions about infant feeding practices; (e) Benefits of, and preparation for, breastfeeding; (f) Appropriate use of nutritional supplements, if prescribed; (g) A postpartum woman's nutritional needs; and (h) The benefits of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). (3) Case coordination and referral for pregnant participants. This component shall include, but not be limited to, the following activities: (a) Telephone reminders before prenatal and postpartum appointments and follow-up telephone contact if the participant misses an appointment; (b) Referral of the participant to the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); (c) Referral of the participant to specialty services as indicated; (d) Referral of the participant to high-risk nutrition counseling as indicated; (e) Referral of the participant to high-risk obstetrician-gynecologist specialists, perinatologists, or other specialists based on the client's medical needs; (f) Arrangements for hospital delivery, including delivery at a tertiary care maternity center as indicated; (g) Arrangements for pediatric care; and (h) Assistance in arranging for transportation to and from clinical services. C. High-Risk Nutrition Counseling Services. These services are provided to nutritionally high-risk pregnant participants. Nutritionally high-risk pregnant participants are identified to the high-risk nutrition counseling services provider through the Healthy Start High-Risk Nutrition Instrument. The services include, but are not limited to, the following: (1) Making a nutritional assessment including the recording and interpretation of anthropometric measurements, clinical and laboratory findings, medical conditions, nutrient and drug interactions, diet history, and psychological, social, cultural, religious, and economic factors affecting food intake; (2) Developing a nutritional care plan based on problems identified through the assessment and integrated into the total plan of care; (3) Determining appropriate interventions to achieve care plan goals consistent with the participant's culture, family composition, and restrictions imposed by income, transportation availability, and neighborhood food resources, including, but not limited to, counseling for food habit and behavior change, diet modifications for medical conditions, and referral for food assistance; and (4) Monitoring and recording participant's progress toward goal achievement. #### Regulation .05 Limitations. *COMAR 10.09.38.05* The Healthy Start Program may not restrict or otherwise affect: A. Eligibility for benefits under Title XIX of the Social Security Act or other available benefits or programs; and B. The provider's right to bill the Program for other covered program services. #### Regulation .06 Payment Procedures. *COMAR 10.09.38.06* A. Request for Payment. (1) Requests for payment of Healthy Start Program services rendered and completed shall be submitted by an approved provider according to procedures established by the Department. Payment requests which are not properly prepared or submitted may not be processed, but shall be returned unpaid to the provider. (2) Requests for payment shall be submitted on the invoice form specified by the Department. A separate invoice shall be submitted for each participant. The completed form shall indicate the: (a) Date or dates of service; (b) Participant's name and Medical Assistance number; (c) Provider's name, location, and provider number; and (d) Nature, unit or units, and procedure code or codes of covered services provided. (3) Providers shall bill the Program for the appropriate fee specified in §C of this regulation. B. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. C. Payments shall be made: (1) Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; (2) According to the applicable rate under COMAR 10.09.02 or 10.09.21 for risk assessment—plan of care, and enriched maternity service; (3) According to methodology described in the memorandum of understanding between the Program and each local health department for risk assessment—plan of care; (4) For high-risk nutrition counseling as follows: (a) To federally qualified health centers, according to COMAR 10.09.08.05; (b) To each local health department, according to the methodology described in the memorandum of understanding between the Program and each local health department; (c) To Maryland qualified health centers, according to COMAR 10.09.08.06; and (d) To all other eligible providers, according to COMAR 10.09.02.07D. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.38.07* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.38.08* Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.38.09* Appeal procedures are as set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.38.10* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 39 — Doula Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: February 21, 2022 (49:4 Md. R. 300) **Administrative History:** Regulation .02 amended effective June 24, 2024 (51:12 Md. R. 618) **Administrative History:** Regulation .06H amended effective June 24, 2024 (51:12 Md. R. 618) #### Regulation .01 Definitions. *COMAR 10.09.39.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Birthing parent” means the participant giving birth, who is receiving doula services throughout their pregnancy, including the prenatal, labor, and postpartum periods. (2) “Certified doula” means a trained nonmedical professional who provides continuous physical, emotional, and informational support to the birthing parent throughout the prenatal and postpartum periods and who has received a certification as approved by the Program to perform doula services. (3) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (4) “Doula services” means continuous physical, emotional, and informational support to the birthing parent throughout the prenatal and postpartum periods, provided by a certified doula, including: (a) Information about the childbirth process; (b) Emotional and physical support provided at perinatal visits and during labor and delivery, which may include: (i) Prenatal coaching; (ii) Providing person-centered care that honors cultural and family traditions; and (iii) Teaching and advocating on behalf of the birthing parent during appointment visits, hospitalization, and delivery; (c) Provision of evidence-based information on general health practices pertaining to pregnancy, childbirth, postpartum care, newborn health, and family dynamics; (d) Provision of emotional support, physical comfort measures, and information to the birthing parent to enable the birthing parent to make informed decisions pertaining to childbirth and postpartum care, and other issues throughout the perinatal period; (e) Provision of support for the whole birth team including a birthing parent’s partner, family members, and other support persons; (f) Provision of evidence-based information on infant feeding; (g) Provision of general breastfeeding guidance and resources to supplement, but not in lieu of, the services of a lactation consultant; (h) Provision of infant soothing and coping skills for the new parents; and (i) Facilitation of access to resources that can improve birth-related outcomes, including ongoing home visiting services, transportation, housing, alcohol, tobacco and drug cessation, WIC, SNAP, and intimate partner violence resources. (5) “Home” means the birthing parent’s place of residence in a community setting. (6) “Labor and delivery” means the period during which the fetus, membranes, umbilical cord, and placenta are expelled from the uterus through vaginal birth or through the surgical delivery by a cesarean section. (7) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (8) “Perinatal period” means the period that encompasses both the prenatal and postpartum periods. (9) “Postpartum period” means the period that begins immediately after childbirth up to 180 days following childbirth. (10) “Prenatal period” means the developmental period between conception and birth. (11) “Program” means the Maryland Medical Assistance Program. (12) “Provider” means an individual doula or an association, partnership, or incorporated or unincorporated group of doulas certified to provide doula services that, through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. #### Regulation .02 Certification Requirements. *COMAR 10.09.39.02* A provider shall be certified as described in the Professional Services Provider Manual and Fee Schedule under COMAR 10.09.02.07D. #### Regulation .03 Conditions for Participation. *COMAR 10.09.39.03* A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. Specific requirements for participation in the Program as a certified doula provider require that the provider: (1) Maintain up-to-date certification through a doula certification program as specified in Regulation .02 of this chapter; and (2) Shall have adequate liability insurance. #### Regulation .04 Covered Services. *COMAR 10.09.39.04* A. Effective January 1, 2022, the Program covers doula services as defined in Regulation .01 of this chapter when the services: (1) Are medically necessary; (2) Are rendered during a birthing parent’s prenatal period, labor and delivery, and postpartum period; and (3) If rendered via telehealth, comply with the requirements established in COMAR 10.09.49 and any other subregulatory guidance. B. The Program shall cover up to: (1) Eight prenatal or postpartum visits; and (2) One labor and delivery service. #### Regulation .05 Limitations. *COMAR 10.09.39.05* Doula services covered under this chapter are subject to the following limitations: A. One of the following providers shall be present while doula services are provided during the delivery: (1) An obstetrician-gynecologist; (2) A family medicine practitioner; or (3) A certified nurse midwife. B. Doula services furnished during labor and delivery may not be rendered via telehealth. C. Payment for doula services shall be limited to direct services provided. Expenses may not be reimbursed for items related to: (a) Travel; (b) Administrative overhead; or (c) Ongoing certification, training, or consultation. D. Multiple visits are not allowed in the same day except in the following instances: (a) A prenatal visit occurs earlier in the day, and a labor and delivery visit later in the day; or (b) A labor and delivery visit occurs earlier in the day, and a postpartum doula later in the day. #### Regulation .06 Payment Procedures. *COMAR 10.09.39.06* A. The provider shall submit the request for payment in the format designated by the Program. B. The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program. C. The provider shall charge the Program the provider's customary charge to the general public. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §H of this regulation; and (2) The provider's reimbursement is not limited to the provider's customary charge. D. The Program will pay for covered services, the lesser of: (1) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The Program's fee schedule. E. The provider may not bill the Program or the participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; (4) Professional services rendered via telehealth when services are indicated as an exclusion; or (5) Providing a copy of a participant's medical record when requested by another provider on behalf of the participant. F. Payments for services rendered to a birthing parent shall be made directly to a qualified provider. G. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. H. Reimbursement. (1) Unless otherwise specified, payments shall be made in 15-minute units of service. (2) The provider shall be reimbursed in accordance with COMAR 10.09.02.07D. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.39.07* Recovery and reimbursement regulations are set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.39.08* Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.39.09* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.39.10* Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. #### Regulation .11 Implementation Date. *COMAR 10.09.39.11* This chapter shall be implemented on January 1, 2022. ### Chapter 40 — Early Intervention Services Coordination **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105,, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective November 19, 1990 (17:24 Md. R. 2835); emergency status extended at 18:4 Md. R. 445 (February 22, 1991); adopted permanently effective February 18, 1991 (18:3 Md. R. 305) **Administrative History:** Chapter revised as an emergency provision effective August 1, 1991 (18:17 Md. R. 1911); amended permanently effective November 1, 1991 (18:21 Md. R. 2308) **Administrative History:** Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .03 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .06A, C amended effective November 13, 2023 (50:22 Md. R. 973) #### Regulation .01 Definitions. *COMAR 10.09.40.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Department as defined in COMAR 10.09.36.01. (2) “Developmental areas” means cognitive development, physical development (including fine and gross motor and sensory development), speech and language development, psychological development, and self-help skills. (3) “Developmental delay” has the meaning stated in COMAR 13A.13.01.03B. (4) “Early intervention services” means services defined in COMAR 13A.13.01.03B(15) that: (a) Are designed to meet the developmental needs of infants and toddlers with disabilities; (b) Are provided under public supervision and in conformity with an IFSP; and (c) Meet applicable State and federal standards. (5) “Early intervention service coordination” means the coordination of services covered under this chapter. (6) “Family” means those individuals with whom a participant resides, who are responsible for the participant, are the primary nurturing caregivers, and have assumed major, long-term roles in the infant or toddler's daily life. (7) “Individualized Family Service Plan (IFSP)” means a participant's written plan for early intervention services which is developed or revised by a multidisciplinary team based on the results of a multidisciplinary assessment or reassessment and is documented in accordance with guidelines issued by the Maryland Infants and Toddlers Program. (8) “Local health department” means the public health services agency in each county and Baltimore City, which receives State and local government funding to ensure that basic public health services in the areas of personal and environmental health are available in each jurisdiction. (9) “Maryland Infants and Toddlers Program” means the program designated by the Governor under Executive Order 01.01.1988.15 to plan, develop, and implement a Statewide, coordinated, comprehensive, multidisciplinary, interagency plan for early intervention services in Maryland. (10) “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (11) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (12) “Multidisciplinary assessment or reassessment” means the process used by a participant's multidisciplinary team to review the child's unique needs, the family's ability to assist in meeting needs related to the child's development, and the nature and extent of early intervention and other services needed by the child. (13) “Multidisciplinary team” means the involvement of two or more disciplines or professions in the provision of integrated and coordinated services, including evaluation and assessment activities and the development of the IFSP. (14) “Parent” has the meaning stated in COMAR 13A.13.01.03B. (15) “Participant” means a federally qualified recipient: (a) Who is aged birth to the beginning of the school year following the child’s fourth birthday; (b) Whose parents have provided written consent for the use of public benefits consistent with COMAR 13A.13.01.12; (c) Who is not receiving the same service coordination services under another Program authority; and (d) Who is defined as a child with a developmental delay as defined in COMAR 13A.13.01.03. (16) “Program” means the Program as defined in COMAR 10.09.36.01. (17) “Provider” means an early intervention service coordination provider. (18) “Service coordination” means the services provided, as part of the Maryland Infants and Toddlers Program, which assists participants in gaining access to the full range of Medical Assistance services, as well as to any additional needed medical, social, mental health, financial assistance, counseling, educational, and other support services. (19) “Service coordinator” means an individual who: (a) Is utilized by the provider and chosen by the participant’s parent; (b) Is designated to carry out the IFSP service coordination activities; (c) Meets the requirements in Regulation .03C of this chapter; and (d) Provides the services specified in Regulation .04 of this chapter. (20) “Telehealth” has the meaning as stated in COMAR 10.09.49.02. #### Regulation .02 Licensing Requirements. *COMAR 10.09.40.02* A. Social workers participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 18, Annotated Code of Maryland, or meet the social worker licensure and regulatory requirements of the state in which the services are provided. B. Registered nurses participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 7, Annotated Code of Maryland, or meet the registered nurse licensure and regulatory requirements of the state in which the services are provided. C. Audiologists participating as service coordinators shall be licensed pursuant to COMAR 10.41.03.03, or meet the audiologist licensure and regulatory requirements of the state in which the services are provided. D. Nutritionists or dietitians participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 4, Annotated Code of Maryland, or meet the corresponding licensure and regulatory requirements of the state in which the services are provided. E. Occupational therapists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 9, Annotated Code of Maryland, or meet the occupational therapist licensure and regulatory requirements of the state in which the services are provided. F. Physical therapists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 13, Annotated Code of Maryland, or meet the physical therapist licensure and regulatory requirements of the state in which the services are provided. G. Clinical psychologists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 16, Annotated Code of Maryland, or meet the clinical psychologist licensure and regulatory requirements of the state in which the services are provided. H. School psychologists participating as service coordinators shall be certified pursuant to COMAR 13A.12.03.08, or meet the school psychologist regulatory requirements of the state in which the services are provided. I. Special educators participating as service coordinators shall be certified pursuant to COMAR 13A.12.01.04, or meet the special educator regulatory requirements of the state in which services are provided. J. Speech language pathologists participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 19, Annotated Code of Maryland, or meet the speech language pathologist licensure or certification and regulatory requirements of the state in which the services are provided. K. Professional counselors participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 15, Annotated Code of Maryland, or meet the professional counselor licensure and regulatory requirements of the state in which services are provided. L. Physicians participating as service coordinators shall be licensed pursuant to Health Occupations Article, Title 14, Annotated Code of Maryland, or meet the physicians’ licensure and regulatory requirements of the state in which the services are provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.40.03* A. General requirements for participation in the Program are that providers shall do the following, either directly through staff or by agreement: (1) Meet all conditions for participation as set forth in COMAR 10.09.36.03; and (2) Maintain a file on each participant which meets the Program’s requirements and which includes for each contact made by the service coordinator: (a) Date and subject of contact, (b) Person contacted, (c) Person making the contact, (d) Nature, content, and unit or units of service provided; (e) Place of service; and (f) Signature and printed name of the service coordinator. B. Specific requirements for participation in the Program as an early intervention service coordinator are that the provider shall do the following, either directly or indirectly by agreement: (1) Use qualified individuals as service coordinators; (2) Have demonstrated expertise in providing family-centered, community-based, coordinated care to children with disabilities, with an emphasis on early intervention services; (3) Develop the IFSP within 45 working days of referral, unless client-related extenuating circumstances are documented in accordance with COMAR 13A.13.01.07B. (4) Have formal written policies and procedures, approved by the Department, which specifically address the provision of early intervention [services case management] service coordination to participants in accordance with the requirements of this chapter; (5) Designate specific qualified individuals as early intervention service coordinators; (6) Maintain on file an initial Individualized Family Service Plan for each participant, and any subsequent revised IFSPs; (7) Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants; (8) Maintain a current listing of medical, social, mental health, financial assistance, education, training, counseling, and other early intervention and support services available to infants and toddlers with disabilities; and (9) Strictly safeguard the confidentiality of a participant's records, so as not to endanger the participant's and the family's legal rights, family relationships, and status in the community. C. A service coordinator shall meet the following requirements: (1) Be a professional who: (a) Has a current license or certification, according to Regulation .02 of this chapter, in the profession most immediately relevant to a participant’s needs; and (b) Has demonstrated training or experience in providing service coordination or other early intervention services to infants and toddlers with disabilities; or (2) Be a nonprofessional who: (a) Has a high school diploma or its equivalency who meets Personnel Standards described in COMAR 13A.07.01.02; (b) Has demonstrated training or experience in providing service coordination or other early intervention services to infants and toddlers with disabilities; and (c) Participates in ongoing training offerings as specified in the interagency plan for early intervention services. #### Regulation .04 Covered Services. *COMAR 10.09.40.04* A. The Program shall reimburse for the services in §§B, C, and D of this regulation, when they have been documented as necessary. B. Initial Service Coordination. (1) A unit of service is defined as a completed initial Individualized Family Service Plan (IFSP) and at least one contact with the participant or the participant’s family, on the participant’s behalf. (2) The covered services include convening and conducting a multidisciplinary team to: (a) Perform a multidisciplinary assessment; and (b) Develop an initial IFSP for a participant that identifies the: (i) Participant’s needs for early intervention, medical, mental and behavioral health, social, educational, financial assistance, counseling, and other support services; (ii) Responsibilities and rights of the participant and the family, (iii) Provider's responsibilities, and (iv) Resources available to provide the needed services. (3) Administrative, supervisory, and monitoring services associated with the initial service coordination are included as a part of the service. C. Ongoing Service Coordination. (1) Ongoing service coordination is provided following the initial service coordination. (2) A unit of service includes all necessary covered services and at least one monthly contact with the participant’s family on the participant’s behalf via: (a) Telephone call; (b) Telehealth or in-person visit; or (c) Written communication. (3) These services include: (a) Maintaining contact with a participant and the family through home visits, office visits, telephone calls, and follow-up services as necessary; (b) Referring the participant to direct service providers, assisting the participant in gaining access to services specified in the IFSP, and providing linkage to agreed-upon direct service providers of early intervention services; (c) Discussing with direct service providers of early intervention services the services needed and available for the participant, determining the quality and quantity of service being provided, following up to identify any obstacles to a participant's utilization of services, coordinating the service delivery, and performing ongoing monitoring to determine whether the recommended services are being delivered and meet the participant's current needs; (d) Providing a participant's family with information and direction that will assist the participant in successfully accessing and using the services recommended in the IFSP; (e) Informing a participant's family of the participant's and the family's rights and responsibilities in regard to specific programs and resources; (f) Conducting, with a participant's family, a periodic review of the participant's IFSP every 6 months, or more frequently if conditions warrant or the family requests a review; (g) A periodic review accomplished at a meeting or by other means acceptable to the family and others involved in the review process, and which determines the following: (i) The degree of a participant's progress toward achieving the goals established in the IFSP, and (ii) Whether the goals or recommended services need to be revised; and (h) Being available to the participant and the family on a nonscheduled basis as necessary for problem resolution and crisis management related to the participant's needs. (4) Administrative, supervisory, and monitoring services associated with the ongoing case management services are included as part of the service. D. Annual IFSP Review. (1) A unit of service is defined as a completed annual IFSP review and at least one contact with the participant or the participant’s family, on the participant’s behalf. (2) The covered services include convening and conducting a multidisciplinary team to: (a) Perform a multidisciplinary reassessment of the participant's status and service needs; and (b) Review and revise, as necessary, the participant's IFSP. #### Regulation .05 Limitations. *COMAR 10.09.40.05* A. Early intervention service coordination is advisory in nature. B. A restriction may not be placed on a qualified participant’s option to receive early intervention service coordination. C. Early intervention service coordination does not restrict or otherwise affect: (1) Eligibility for Title XIX benefits or other available benefits or programs; (2) The freedom of a participant's parent or family to select from all available services for which the participant is found to be eligible; (3) A participant's parent or family's free choice among qualified providers, in the participant's behalf; or (4) A provider's right to bill the Program for other covered Program services. D. Early intervention service coordination may not be: (1) Provided as an integral and inseparable part of another covered Program service; (2) Provided as an administrative function necessary for the proper and efficient operation of the State's Medical Assistance plan; (3) Rendered in connection with the implementation of §1915(b) or (c) of the Social Security Act; or (4) Delivered as part of institutional discharge planning. E. Reimbursement may not be made for early intervention service coordination if a participant is receiving a comparable case management service under another Program authority. F. A participant’s service coordinator may not be the participant’s parent. #### Regulation .06 Payment Procedures. *COMAR 10.09.40.06* A. Request for Payment. (1) Requests for payment of early intervention service coordination shall be submitted by an approved provider according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all claims not properly signed and completed. (2) A provider shall submit a request for payment on the claim form designated by the Department. A separate claim shall be submitted for each participant. (3) The completed claim form in §A(2)B of this regulation shall indicate the: (a) Date or dates of service; (b) Participant's name and Medical Assistance number; (c) Provider's name, location, and provider number; and (d) Nature, unit or units, and procedure code or codes of covered services provided. (4) Providers shall bill the Program for the appropriate fee specified in §C of this regulation. (5) The Program may not make direct payment to participants. B. Billing Time Limitations. Billing time limitations shall be as set forth in COMAR 10.09.36.06. C. Payment shall be made: (1) Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; (2) Only to one provider of early intervention service coordination rendered to a participant during a billing period; and (3) According to the following fee-for-service schedule for early intervention service coordination: (a) Initial service coordination (only one unit of service may be reimbursed per participant) ... $500; (b) Ongoing service coordination (only one unit of service per month may be reimbursed for a participant after completion of initial service coordination or the annual IFSP review) ... $150; (c) Annual IFSP review ... $275 per review. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.40.07* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.40.08* Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.40.09* Appeal Procedures shall be as set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.40.10* State regulations shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 41 — Employed Individuals with Disabilities **Authority:** Health-General Article, §15-138, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.13 adopted as an emergency provision effective April 1, 2006 (33:9 Md. R. 795); adopted permanently effective July 3, 2006 (33:13 Md. R. 1063) **Administrative History:** Regulation .01A amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .02C amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .02C amended effective May 27, 2013 (40:10 Md. R. 917); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .03 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .03B amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087) **Administrative History:** Regulation .04 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .04 amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087) **Administrative History:** Regulation .04D amended effective May 27, 2013 (40:10 Md. R. 917) **Administrative History:** Regulation .05 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .06 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .06C amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .07 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .07 amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .07A amended effective May 27, 2013 (40:10 Md. R. 917); December 25, 2023 (50:25 Md. R. 1087) **Administrative History:** Regulation .08 amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .08 amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .09A amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .10C amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .12J amended as an emergency provision effective October 1, 2008 (35:22 Md. R. 1955); amended permanently effective February 9, 2009 (36:3 Md. R. 208) **Administrative History:** Regulation .12J amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .13 amended effective February 16, 2015 (42:3 Md. R. 316) #### Regulation .01 Purpose. *COMAR 10.09.41.01* The purpose of this chapter is to increase employment opportunities by making Medical Assistance coverage available to employed individuals with disabilities who meet: A. The disability criteria under Title II or XVI of the Social Security Act; and B. The nonfinancial and financial eligibility requirements established in this chapter. #### Regulation .02 Definitions. *COMAR 10.09.41.02* A. Applicability of COMAR 10.09.24.02 Definitions. (1) Except as provided in §A(2) of this regulation, terms used in this chapter that are not defined in §C of this regulation have the meanings stated for the same terms in COMAR 10.09.24.02. (2) If a term's definition in COMAR 10.09.24.02 references a “local department of social services” in the context of a determination of eligibility, the words “local department of social services” in the COMAR 10.09.24.02 definition shall be replaced, for purposes of the term's meaning in this chapter, with “the Department” . B. In this chapter, the following terms have the meanings indicated. C. Terms Defined. (1) “Applicant” means an individual: (a) Who is not a recipient; (b) Who has submitted to the Department an application for the Employed Individuals with Disabilities coverage group; and (c) Whose application has not received final action. (2) “Application” means the filing with the Department of a written and signed application form for the Employed Individuals with Disabilities (EID) coverage group to establish eligibility for Medical Assistance benefits. (3) “Application date” means the date a written and signed application form for determination or redetermination of eligibility for the EID coverage group is received by the Department. (4) “Assistance unit” means an applicant or recipient and, when living together, the applicant's or recipient's spouse, whose eligibility for Medical Assistance benefits is determined in conjunction with each other. (5) “Certification period” means a period of time of up to 12 months, beginning on the first day of the month in which the Department receives the application, for which the EID applicant’s or recipient’s eligibility to receive Medical Assistance benefits is certified. (6) “Chronic hospital” has the meaning stated in COMAR 10.09.06.01B. (7) “Continuing eligibility” means a recipient's EID eligibility for a subsequent certification period after the current certification period, based on the Department's redetermination of eligibility with respect to an individual who is enrolled in the EID coverage group on the application date. (8) “Days” has the meaning stated in Article I, §36, Annotated Code of Maryland. (9) “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. (10) “Determination” means a decision by the Department regarding an applicant's or recipient's eligibility for the EID coverage group. (11) “Disability” means an individual's medically determinable impairment that is the basis of a determination that the individual is disabled, according to the standards set forth in §1614(a)(3) of the Social Security Act, except substantial gainful activity is not considered in determining disability. (12) “Disabled” means having a disability. (13) “Disregard” means a fixed monetary amount or documented expense that is deducted from countable gross income to determine countable net income. (14) “Employed” means being engaged in employment: (a) That is verifiable; (b) That yields earnings during the period under consideration; and (c) The earnings from which are subjected to reporting, withholding, and payment as required by law, including but not limited to individual income tax, payroll tax, estimated income tax, and withholding or payments required by the Federal Insurance Contribution Act. (15) “Employed Individuals with Disabilities (EID)” means the Medical Assistance coverage group for employed individuals with disabilities, which is: (a) Operated under the regulations of this chapter; (b) Funded jointly by the State and the federal governments; and (c) Administered by the Department. (16) “Employer-sponsored insurance (ESI)” means group health insurance coverage provided wholly or partly at the expense of an applicant's, recipient's, or spouse's employer. (17) “Employment” means working for payment either for an employer or on a self-employed basis. (18) “Excludable” means the types of income and resources that are specified in this chapter as not countable in the determination of eligibility for the EID coverage group. (19) “Family unit size” means the number of individuals included in an assistance unit, which is used to determine the applicable income or resource standard. (20) “Grace period” means a period of time not longer than 6 months during which an unemployed EID recipient pays premiums and remains eligible to receive EID benefits despite failing to meet the requirement that EID recipients be employed. (21) “Hardship” means financial adversity or misfortune significant enough that it reasonably can be expected to compromise an applicant's or recipient's ability to obtain and provide basic food, shelter, and clothing for the applicant or recipient, another member of the assistance unit, or any dependents of the applicant or recipient. (22) “Health insurance” has the same meaning as “health insurance coverage”, as stated in COMAR 10.09.43.02B. (23) “Initial eligibility” means the EID eligibility of an individual who is not enrolled in the EID coverage group on the application date. (24) “Long-term care facility services” means services delivered to patients admitted to a nursing facility, chronic hospital, or a rehabilitation hospital. (25) “Medical criteria for disability” means the criteria applied by the Social Security Administration (SSA) to determine disability under Title XVI of the Social Security Act, except for the disability criteria that consider an individual's earnings as evidence of an ability to perform substantial gainful activity. (26) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (27) “Notice of eligibility” means the written notice issued by the Department informing an applicant or recipient of: (a) The Department's finding of eligibility or ineligibility; and (b) The legal rights and obligations of the applicant or recipient associated with the Department's determination. (28) “Nursing facility” has the meaning stated in COMAR 10.09.10.01B. (29) “Period under consideration” means a period of 6 months, beginning on the first day of the month of the application date, for which an assistance unit's income is assessed for a determination of eligibility under this chapter. (30) “Premium” means the monthly amount an applicant or recipient is required to pay, absent a successful claim of hardship pursuant to Regulation .07C of this chapter, as a condition of eligibility for the EID coverage group and Medical Assistance benefits. (31) “Provider” has the same meaning as “health care provider”, as stated in Health-General Article, §19-132, Annotated Code of Maryland. (32) “Recipient” means an individual who has been determined eligible for the EID coverage group. (33) “Redetermination” means a determination by the Department, at least every 12 months, regarding the continuing eligibility of a recipient, in accordance with the requirements of this chapter. (34) “Rehabilitation hospital” has the same meaning as “special rehabilitation hospital”, as stated in COMAR 10.07.01.02C. (35) “Social Security Disability Insurance (SSDI)” means a federally administered program that provides benefits to individuals with disabilities who have paid sufficient Social Security taxes to be eligible for disability insurance payments under Title II of the Social Security Act, 42 U.S.C §423 et seq. (36) “Substantial gainful activity” has the meaning stated in 20 CFR §416.910, which the Social Security Administration applies in determining disability under Title XVI of the Social Security Act. #### Regulation .03 Nonfinancial Eligibility. *COMAR 10.09.41.03* A. The Department shall determine whether an applicant or recipient meets the nonfinancial eligibility requirements for Medical Assistance benefits under this regulation. B. An applicant or participant meets the nonfinancial eligibility requirements for Medical Assistance benefits under this regulation if the applicant or participant: (1) Is 16 years old or older, but younger than 65 years old; (2) Is employed, except when an unemployment grace period described under Regulation .07 of this chapter applies, and verifies employment and compliance with all applicable requirements relating to FICA, income tax reporting, withholding, and payment requirements, including, if self-employed, payment of estimated taxes, by submitting documentation such as: (a) Pay stubs; (b) A letter from the employer verifying the applicant's or recipient's employment; (c) Bank statements showing deposits of earnings; (d) Income tax returns; (e) Evidence of payment of estimated taxes; or (f) Business ledgers; (3) Except for the consideration of substantial gainful activity, meets the definition of disability in §1614(a)(3) of the Social Security Act, as determined by: (a) The Department pursuant to a disability determination process for applicants who have not had a disability determination completed by the Social Security Administration within the time period prescribed in §C(2) of this regulation; or (b) The Social Security Administration, if the applicant or recipient: (i) Receives SSDI benefits; or (ii) Has lost eligibility for SSDI or SSI for any reason other than medical improvement; (4) As specified in COMAR 10.09.24: (a) Meets the eligibility requirements for Medical Assistance as to: (i) Citizenship; and (ii) Residency; and (b) Is not: (i) An institutionalized person; (ii) An inmate of a public institution; or (iii) An inpatient in an institution for mental disease; and (5) Is not a current recipient of: (a) Comprehensive Medical Assistance benefits pursuant to COMAR 10.09.24; or (b) Benefits under the Maryland Children's Health Program pursuant to COMAR 10.09.11 or 10.09.43. C. Periodic Redetermination of Disability. (1) The Department shall periodically review a recipient's impairments to determine continuing disability status, consistent with §C(2) of this regulation. (2) Frequency of Continuing Disability Reviews. The Department may schedule the periodic disability reviews required by §C(1) of this regulation at a frequency that is consistent with the time frames set forth in federal law and regulations as specified in 20 CFR §416.989, as amended, and 20 CFR §416.990, as amended, which are incorporated by reference. #### Regulation .04 Financial Eligibility. *COMAR 10.09.41.04* A. Assistance Unit. An applicant's or recipient's assistance unit shall include the: (1) Applicant or recipient; and (2) Applicant's or recipient's spouse when living in the same household, whether or not the spouse is eligible for the same benefits under this chapter. B. Consideration of Income. (1) Except as provided in §B(2) or C of this regulation, the Department shall determine, in accordance with the policies and procedures for aged, blind, or disabled coverage groups specified at COMAR 10.09.24, the countable net income of an EID applicant or participant for purposes of determining the applicable premium amount under Regulation .07 of this chapter. (2) To determine the countable net income of an EID assistance unit, the Department shall subtract from the assistance unit's total gross income: (a) The general income exclusions and disregards and the specific income exclusions and disregards for aged, blind, or disabled coverage groups specified at COMAR 10.09.24; and (b) An amount equal to the applicant's, recipient's, or spouse's documented out-of-pocket cost of premium payments to secure current employer-sponsored insurance coverage that includes coverage of the applicant or recipient. (3) As a condition of eligibility for Medical Assistance benefits under this chapter, unless good cause for not doing so is shown, applicants and recipients, shall take all necessary steps to obtain any annuities, pensions, retirement, and disability benefits to which they are entitled, including, but not limited to: (a) Veterans' compensation and pensions; (b) Old Age and Survivors' Disability Insurance (OASDI) benefits; (c) Railroad retirement benefits; (d) Unemployment compensation; or (e) Social Security Disability Income (SSDI). (4) Income Standards. Effective January 1, 2024, no income standard applies to applicants or participant under this chapter. C. Consideration of Resources. (1) Except as provided in this section, whether an applicant meets the resource standards for eligibility for the EID coverage group shall be determined according to the policies and procedures for aged, blind, or disabled coverage groups specified in COMAR 10.09.24. (2) To determine the total countable resources of an applicant, the Department shall apply the general resource exclusions and specific resource exclusions for aged, blind, or disabled coverage groups specified in COMAR 10.09.24 to the total gross resources of the applicant. (3) From the total countable resources of the applicant determined pursuant to §C(1) and (2) of this regulation, the Department shall subtract the aggregate current cash value of the applicant’s or participant’s ownership interest in any of the following types of accounts: (a) 401(k) retirement account; (b) 403(b) retirement account; (c) Pension plan; (d) Keogh plan; (e) Individual retirement account (IRA); (f) Independence Account; or (g) Other retirement accounts as defined by the IRS. (4) For an applicant or participant to be eligible for Medical Assistance benefits under this chapter, the countable resources attributed to the applicant’s or participant’s assistance unit pursuant to §§C and D of this regulation may not exceed $10,000 for an individual. D. Independence Accounts. (1) Account Provisions. (a) Contributions to any of the participant’s registered Independence Accounts are subject to the rules described in this section and to any policies of the respective financial institution governing the account. (b) All contributions to the participant’s Independence Account or accounts, including interest, dividends, or other gains from the principal, shall be treated as an exempt asset for the purpose of calculating eligibility for Medical Assistance and the EID program. (c) The purpose of an Independence Account is to allow the participant to purchase any items or services that may aid in the participant’s pursuit of personal or financial independence. (d) The EID participant shall be the sole owner of any account registered as an Independence Account. (e) The Department shall assess the participant’s Independence Account as a part of the verification process at redetermination for Medical Assistance. The review process shall include verifying all contributions to the participant’s Independence Account with the financial institution holding the participant’s account. (f) The total amount a participant deposits in all independence accounts during an annual certification period may not exceed the participant’s gross earned income for that annual certification period. (2) Independence Account Registration. (a) A person shall complete an account registration form to register an applicable account as an Independence Account with the Department. (b) A person shall re-register the Independence Account with the Department if the financial institution or other information for the Independence Account changes. (c) The applicant or participant shall report any changes in personal or financial status that may affect the applicant’s or participant’s eligibility for Medical Assistance as described in COMAR 10.09.24. (d) For all registered Independence Accounts, the date of account creation may be no earlier than the date an EID participant is determined eligible for Medical Assistance under this section. (e) For all registered Independence Accounts, the funds in the Independence Account shall be held separate from the participant’s non-exempt assets. #### Regulation .05 Application Requirements — Determination and Redetermination of Eligibility. *COMAR 10.09.41.05* A. Application. (1) To any individual requesting information, the Department shall provide oral or written information about: (a) EID eligibility requirements; (b) The coverage, scope, and related services of the Medical Assistance Program; and (c) Applicants' and recipients' rights and obligations under the Medical Assistance Program. (2) The Department shall issue an EID application form to any individual upon request. (3) An applicant or recipient may apply for a determination or a redetermination of eligibility for the EID coverage group by submitting to the Department: (a) The application form designated by the Department and signed in accordance with the signature requirements of COMAR 10.09.24; (b) The social security numbers of each member of the assistance unit, in accordance with §A(5) of this regulation; and (c) Signed consent forms as specified in §A(4) of this regulation. (4) Consent Forms. An applicant or recipient, or, if necessary and consistent with the signature requirements specified in COMAR 10.09.24, a representative or other individual acting on behalf of the applicant or recipient, shall sign consent forms as needed to authorize the Department's verification of information needed to establish eligibility through sources such as employers, banks, and public or private agencies. (5) Social Security Number. (a) As required in COMAR 10.09.24 for each assistance unit member requesting benefits under this chapter, an applicant or recipient shall: (i) Provide the Department with the individual's Social Security number; or (ii) Verify that the individual has applied to the Social Security Administration for a Social Security card. (b) An applicant's or recipient's failure to meet the requirements of §A(5)(a) of this regulation shall result in a determination of ineligibility under this chapter. (6) An applicant or recipient shall provide to the Department information and verifications needed for the determination of all elements of nonfinancial, income, and resource eligibility, including but not limited to information relating to health insurance coverage or potential third-party payments. (7) Additional Information Requirements. An applicant or recipient shall, at the Department's request: (a) Be available for and participate in an interview; and (b) Answer questions and provide information relevant to: (i) The applicant's eligibility for the EID coverage group; or (ii) The recipient's continuing eligibility for the EID coverage group. (8) An individual temporarily absent from the State who intends to return to the State: (a) May apply to the Department by mail for the EID coverage group; and (b) To establish eligibility for the EID coverage group, shall: (i) Demonstrate continued residency in the State; and (ii) Meet all technical and financial requirements of eligibility under this chapter. (9) An applicant or recipient shall cooperate and assist with the Department's eligibility determination or redetermination process under this chapter, including but not limited to the requirements of §A of this regulation. B. The Department shall: (1) Maintain a case record for the applicant or recipient, including documentation of all required elements of eligibility; (2) Conduct a wage-screening inquiry to determine wages, benefits, and claimant history for each assistance unit member; (3) Verify all factors of eligibility under this chapter for each assistance unit member applying for the EID coverage group; and (4) Restrict disclosures of information concerning applicants and recipients to purposes directly connected with the administration of the EID coverage group of the Medical Assistance program. #### Regulation .06 Time Standards. *COMAR 10.09.41.06* A. Time Standards for the Department. (1) Disability Determined by Social Security Administration. With respect to an application submitted by an individual determined to be disabled as provided in Regulation .03B(3)(b) of this chapter, unless the time standard is extended pursuant to §D of this regulation, the Department shall, not later than 30 days from the application date: (a) Complete its determination or redetermination of eligibility, subject to any premium payment required by Regulation .07 of this chapter, and issue a written notice that satisfies the requirements of Regulation .08B of this chapter; or (b) Determine that it cannot complete its eligibility determination without additional information or verifications, and issue a written notice that informs the applicant or recipient of: (i) The information and verifications required to determine or redetermine eligibility; and (ii) The due dates for the Department's eligibility determination and for the applicant's or recipient's provision of the additional information and verifications requested by the Department. (2) No Disability Determination by Social Security Administration. Unless the time standard is extended pursuant to §D of this regulation with respect to an applicant who has had no determination of disability or continuing disability completed by the Social Security Administration within the time frame prescribed by Regulation .03C(2) of this chapter, the Department shall complete the requirements specified in §A(1)(a) or (b) of this regulation not later than 90 days from the application date. (3) Time Standard for Redeterminations. Before the beginning of a new certification period, the Department shall: (a) Issue a redetermination form to a recipient at least 60 days before the end of the current certification period; and (b) Perform a redetermination of a recipient's eligibility, subject to any premium payment required by Regulation .07 of this chapter, for the EID coverage group. B. Time Standards for Applicants and Recipients. (1) Unless the time standard is extended pursuant to §D of this regulation, the applicant or recipient shall, within the time standards specified in §B(2)—(4) of this regulation, provide to the Department: (a) The completed and signed application required by Regulation .05A(3) of this chapter; and (b) The information and verifications, if any, requested by the Department pursuant to §A(1)(b) of this regulation. (2) If the Department's request for information or verification is part of the application packet, an applicant or recipient shall provide the signed and completed application and supporting information and materials specified in Regulation .05A(3) of this chapter to the Department early enough for the Department to meet the 30-day time standard specified in §A of this regulation for completion, subject to any premium payment required by Regulation .07 of this chapter, of an eligibility determination or redetermination. (3) If the Department's request is made after the application date, an applicant or recipient shall provide the requested information and verifications to the Department within 10 days of the date of the Department's notice pursuant to §A(1)(b) of this regulation. (4) For redeterminations, the recipient shall provide to the Department, by the last day of the current certification period, all materials and information required by §B(1)—(3) of this regulation. C. Time for Payment of Premium. (1) Unless a claim of hardship is raised pursuant to Regulation .07C of this chapter, an applicant or recipient shall submit, within the time allowed by §B of this regulation, the premium required by Regulation .07A of this chapter. (2) If a claim of hardship raised pursuant to Regulation .07C of this chapter is denied by the Department, the applicant or recipient to whom Regulation .07C(3) of this chapter applies shall pay the premium required by Regulation .07A of this chapter within 10 days of the date of the Department’s notice pursuant to Regulation .07C(2) of this chapter. D. Extension of Time Standards. (1) The Department shall extend the time standards specified in §B of this regulation if: (a) The applicant or recipient is actively attempting to establish eligibility but has been unable to provide the required information or verifications due to circumstances beyond the applicant's or recipient's control; or (b) There is an administrative delay or emergency beyond the control of the Department. (2) If the circumstances described in §D(1) of this regulation are present: (a) The Department shall document in the applicant's or recipient's record the reason for the delay; and (b) The extension of time shall continue as long as the requirements of §D(1) of this regulation are met. E. Effect of Noncompliance with Time Standards. The Department shall deny the application for the EID coverage group and issue a notice of ineligibility or termination pursuant to Regulation .08C of this chapter if: (1) The applicant or recipient fails to meet the timeliness requirements of §B of this regulation without the circumstances set forth in §D(1) of this regulation being present; or (2) The time standard for the applicant's or recipient's submission of information and verifications set forth in §B of this regulation initially was extended pursuant to §D(1) of this regulation, but the requirements of §D(1) of this regulation are no longer met. F. The standards of timeliness for acting on applications may not be used: (1) To deny eligibility except as provided in §E of this regulation; or (2) As a waiting period for EID enrollment of eligible individuals. G. Withdrawal and Reactivation of Application. (1) An individual who has filed an application for the EID coverage group with the Department may voluntarily withdraw the application at any time. (2) An individual who has withdrawn an application for the EID coverage group may not reactivate the application except as provided in COMAR 10.09.24. (3) If an applicant or recipient withdraws a pending application, the application form shall remain the property of the Department. #### Regulation .07 Premium. *COMAR 10.09.41.07* A. Submission of Premium. (1) Unless an exception under §A(2) of this regulation applies or a timely claim of hardship is raised pursuant to §C of this regulation, an applicant or recipient shall, as a condition of eligibility for the EID coverage group, pay the premium specified in §A(3) of this regulation. (2) Limitation of Premium Requirement. (a) An applicant or recipient with income at or below the federal poverty level is not required to pay a premium as a condition of eligibility in the EID coverage group. (b) With respect to an applicant determined eligible subject to the requirements of §A(3) of this regulation, the Department shall waive the premium payment before the notice of eligibility for a period not to exceed 6 months if such notice of eligibility is delayed by factors beyond the applicant's control. (3) An applicant or participant whose assistance unit has income: (a) Above the federal poverty level, but at or below 200 percent of the federal poverty level, shall pay a monthly premium of $25; (b) Above 200 percent, but at or below 250 percent of the federal poverty level, shall pay a monthly premium of $40; (c) Above 250 percent, but at or below 300 percent of the federal poverty level, shall pay a monthly premium of $55; (d) Above 300 percent, but at or below 450 percent of the federal poverty level, shall pay a monthly premium of 4 percent of the monthly net countable income determined under Regulation .04B of this chapter; (e) Above 450 percent, but at or below 600 percent of the federal poverty level, shall pay a monthly premium of 5 percent of the monthly net countable income determined under Regulation .04B of this chapter; or (f) Above 600 percent of the federal poverty level, shall pay a monthly premium of 7.5 percent of the monthly net countable income determined under Regulation .04B of this chapter. (4) Request for Payment. With respect to an applicant or recipient determined eligible subject to the requirements of §A(3) of this regulation, the Department shall issue a request for payment of the applicable premium, indicating that the applicant or recipient shall pay the amount specified within 30 days of the date the Department mailed the request for payment. (5) An applicant or recipient to whom §A(3) of this regulation applies shall, within 30 days of the Departments request for payment pursuant to Regulation §A(4) of this regulation: (a) Pay the full premium due as specified in the request for payment issued pursuant to §A(4) of this regulation; or (b) Submit a claim of hardship as authorized by §C of this regulation. (6) Upon request by the recipient, the Department shall approve an unemployment grace period, not to exceed 6 months within a 12-month period, provided the recipient: (a) Has unemployment due to medical reasons or involuntary job loss; (b) Is otherwise eligible for EID; and (c) Continues to pay the premium during the unemployment grace period. B. Nonpayment of Premium. (1) If an applicant who is required to pay a premium under §A(3) of this regulation, and is the subject of a request for payment issued by the Department pursuant to §A(4) of this regulation, does not pay the premium or submit a hardship claim within 30 days of the Department's notice, the Department shall: (a) Determine the applicant is not eligible for the EID coverage group; and (b) Issue a denial notice as required by Regulation .08C(1) of this chapter. (2) If recipient who is required to pay a premium under §A(3) of this regulation, and is the subject of a request for payment issued by the Department pursuant to §A(4) of this regulation, does not pay the premium or submit a hardship claim within 30 days of the Department's notice, the Department shall: (a) Determine the recipient is not eligible for the EID coverage group; (b) Issue a termination notice as required by Regulation .08C(2) of this chapter; and (c) Refer the recipient to the Central Collection Unit. (3) An applicant or recipient whose eligibility is denied or terminated due to failure to pay the premium as specified in §A(4) of this regulation may not be reenrolled in the EID coverage group until the applicant or recipient pays all monies due to the Department in full. C. Hardship. (1) If the applicant or recipient suffers financial adversity or misfortune so severe that payment of the premium would compromise the applicant's or recipient's ability to obtain and provide basic food, shelter, and clothing for members of the assistance unit or other legal dependents of the applicant or recipient, the applicant or recipient may submit a claim of hardship, specifying the underlying circumstances, to the Department. (2) The Department shall evaluate the claim of hardship and notify the applicant or recipient of its decision within 30 days of the Department's receipt of the written claim of hardship. (3) If the Department determines that the applicant or recipient's claim of hardship is without merit, the applicant or recipient shall pay the applicable premium within 10 days after the date the Department's notice is issued pursuant to §C(2) of this regulation. #### Regulation .08 Determination, Notice, and Certification Period. *COMAR 10.09.41.08* A. Department's Determination. Based on the information presented, the Department shall determine whether an applicant or recipient is or is not eligible for the EID coverage group under this chapter. B. Finding of Eligibility or Continuing Eligibility. (1) Notice of Initial Eligibility. If the Department determines that an applicant is eligible, subject to the requirements of Regulation .07A of this chapter, for the EID coverage group, the Department shall issue to the applicant written notice that includes: (a) A statement of the finding of eligibility, as applicable, indicating the beginning and ending dates of coverage, in accordance with §E of this regulation; and (b) Notice of the right to request a hearing pursuant to Regulation .13 of this chapter. (2) Notice of Continuing Eligibility. If the Department determines that a recipient qualifies for continuing eligibility for the EID coverage group, the Department shall issue to the recipient a written notice that includes: (a) A statement of the finding of continuing eligibility, indicating the beginning and ending dates of coverage, in accordance with §E of this regulation; and (b) A notice of the right to request a hearing pursuant to Regulation .13 of this chapter. C. Denial or Termination. (1) Applicant—Denial Notice. If the Department determines that an applicant is not eligible for the EID coverage group, the Department shall issue to the applicant a written denial notice that includes: (a) A statement of the Department's finding for the EID coverage group; (b) The reason for the finding; (c) The regulation supporting the finding; and (d) Notice of the right to request a hearing pursuant to Regulation .13 of this chapter. (2) Recipient—Notice of Termination. If the Department finds that a recipient is no longer eligible for the EID coverage group, the Department shall issue to the recipient a written notice of termination that includes: (a) A statement of the Department's finding that the recipient is no longer eligible for the EID coverage group; (b) The reason for the finding; (c) The regulation supporting the finding; and (d) Notice of the right to request a hearing pursuant to Regulation .13 of this chapter. D. Grounds for Department's Denial or Termination. (1) If the Department finds one or more of the reasons for denial or termination listed in §D(2) of this regulation with respect to an applicant or recipient, the Department shall determine that: (a) An applicant is not eligible for the EID coverage group and issue a notice of denial as specified in §C(1) of this regulation; or (b) A recipient is no longer eligible for the EID coverage group and issue a notice of termination as specified in §C(2) of this regulation. (2) Grounds for denial or termination from the EID coverage group shall include that an applicant or recipient: (a) Does not meet, or no longer meets, the EID eligibility criteria for: (i) Nonfinancial eligibility, as specified in Regulation .03 of this chapter; or (ii) Financial eligibility, as specified in Regulation .04 of this chapter; (b) Did not submit, within the time standard specified in Regulation .06B of this chapter: (i) A complete application, signed by the applicant as required by Regulation .05A(3) of this chapter; and (ii) All information and verifications requested by the Department pursuant to Regulation .05A(3)—(7) of this chapter, to determine the applicant’s or recipient’s eligibility for the EID coverage group; (c) Did not cooperate with the Department’s eligibility determination process as required by Regulation .05A(9) of this chapter; (d) Did not: (i) Pay the premium required by Regulation .07A of this chapter; or (ii) Submit a claim of hardship that was approved by the Department pursuant to Regulation .07C of this chapter; (e) Did not comply with the posteligibility requirements specified in Regulation .09B and C of this chapter; or (f) Died. E. Certification Period. (1) A recipient's certification period for initial eligibility shall begin on the first day of the month in which the Department receives the application. (2) For a recipient approved by the Department for continuing eligibility, the next certification period shall begin on the first day of the month immediately following the month in which the previous certification period ends. (3) Unless the recipient is terminated before the end of the certification period due to a change in circumstances or other reason for ineligibility, a recipient’s certification period ends, except as provided in §§D(2)(f) and E(4) of this regulation, on the last day of the current 12-month eligibility period. (4) A recipient's certification period may be extended if the Department requires additional time to complete its redetermination of the recipient's eligibility. #### Regulation .09 Posteligibility Requirements. *COMAR 10.09.41.09* A. Department's Responsibility. If it makes a determination as described in Regulation .08A of this chapter, the Department shall: (1) Inform the applicant or recipient of the applicant's or recipient's legal rights and obligations; and (2) Provide to the applicant or recipient written notice of the findings, rights, and obligations as specified in COMAR 10.09.24.12A(2) and (4) and Regulation .08B or C of this chapter. B. Recipient Responsibility. (1) A recipient or the recipient's representative shall: (a) Notify the Department within 10 business days of changes that may affect the recipient's eligibility for EID; (b) Limit use of the Medical Assistance card to the individual whose name appears on the card; (c) Cooperate with the Department by completing forms to report all pertinent information that would assist the Department in seeking reimbursement for expenditures made on the recipient's behalf; (d) If services covered under the State Plan are provided for injuries resulting from an accident, provide to the Department: (i) Notice as to the time, date, and location of the accident; (ii) The name and address of the attorney; (iii) The names and addresses of all parties and witnesses to the accident; and (iv) The police report number if an investigation is made; (e) If written notice of cancellation is received, discontinue use of the Medical Assistance card on the first day of ineligibility; and (f) Cooperate with the Medical Assistance Quality Control—Program Integrity. (2) A recipient's failure to comply with the provisions of §B(1) of this regulation may result in the adverse consequences specified in COMAR 10.09.24, including: (a) Termination of benefits under this chapter; and (b) Legal action. C. Additional Recipient Responsibilities Concerning Third Party Reimbursement. A recipient of Medical Assistance in the EID coverage group: (1) Is considered, as specified in COMAR 10.09.24, to have created an authorization for the release of data, records, and information necessary for the Department's pursuit of third-party reimbursement; (2) Shall assign benefits to the Department and cooperate in the Department's recovery procedures as required in COMAR 10.09.24; and (3) Shall assist and cooperate with the Department's efforts to collect available health insurance benefits and other third party payments as specified in this regulation and Regulation .12 of this chapter. #### Regulation .10 Covered Services. *COMAR 10.09.41.10* A. Except as provided in §§B and C of this regulation, a recipient in the EID coverage group is covered for medically necessary services required by the recipient, if the services are: (1) Furnished by a provider who, with respect to the services rendered, is approved by the Department to participate in the Medical Assistance Program; (2) Covered under the State Plan; (3) Not covered under ESI or any other health insurance coverage besides Medical Assistance; and (4) Not the subject of any third party liability. B. Copayments, Deductibles, and Coinsurance. Medical Assistance does not cover any copayments, deductibles, or coinsurance applicable to the ESI coverage of a recipient in the EID coverage group. C. An EID recipient is not entitled to: (1) Enrollment in the Maryland Medicaid Managed Care Program (HealthChoice) in accordance with COMAR 10.09.62—10.09.75; (2) Enrollment in Rare and Expensive Case Management (REM), in accordance with COMAR 10.09.69; (3) Enrollment in the Program of All-Inclusive Care for the Elderly (PACE) under COMAR 10.09.44; or (4) Long-term care facility services exceeding 30 consecutive days. #### Regulation .11 Conditions of Participation and Reimbursement. *COMAR 10.09.41.11* The requirements for provider participation and reimbursement for services furnished to Medical Assistance recipients in the EID coverage group are governed by the same authorities that apply to services furnished to Medical Assistance recipients in other coverage groups, including: A. General Medical Assistance Provider Participation Criteria, as specified in COMAR 10.09.36; and B. Service-specific provisions included within regulations applicable to individual service categories. #### Regulation .12 Fraud, Liens, Recovery, and Reimbursement. *COMAR 10.09.41.12* A. The provisions of COMAR 10.09.24.14 concerning fraud apply to this chapter. B. The Department shall make a claim against income or resources, or both, of a recipient for benefits correctly paid, or to be paid, under the circumstances specified in COMAR 10.09.24.15A-1. C. The Department may impose a lien on the property of a recipient under the circumstances specified in COMAR 10.09.24.15A-2(1). D. The Department shall seek recovery of Medical Assistance benefits correctly paid as provided in COMAR 10.09.24.15A-3. E. The Department shall accept reimbursement if voluntarily offered by a current or former recipient or by someone acting on behalf of the current or former recipient. F. Extended Benefits Pending a Hearing Decision. (1) The Department shall refer for reimbursement consideration all cases in which: (a) A recipient received extended benefits pending a hearing and decision by the hearing officer; and (b) The hearing officer affirmed the decision of the Department that was the subject of the appeal. (2) The Department: (a) Shall institute procedures to recover the cost of any expenditures made on behalf of a recipient in cases identified in §F(1) of this regulation; and (b) May not apply §F(2)(a) of this regulation to an individual who requested a hearing and extended benefits based on a bona fide belief that the adverse action was erroneous. G. The Department shall refer for investigation and other appropriate action all cases in which a recipient has received coverage erroneously as a result of the action or inaction of the recipient, representative, or individual acting responsibly for the recipient. H. The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or individual acting responsibly for the recipient. I. Providers. (1) If a recipient has ESI or other coverage, or if any other individual is obligated, either legally or contractually, to pay for, or to reimburse the recipient for, services covered by this chapter, a provider of covered services shall seek payment from that source before submitting a claim to the Medical Assistance Program. (2) If an insurance carrier rejects the provider's claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Medical Assistance Program, which shall be accompanied by a copy of the insurance carrier's notice or remittance advice. (3) If payment is made by both the Medical Assistance Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Medical Assistance Program or the insurance or other source, whichever is less. (4) A provider shall reimburse the Department for any overpayment. J. Recipients. A recipient shall assist and cooperate with the Department's efforts to collect available health insurance benefits and other third party payments by: (1) Completing a form designated by the Department to report all pertinent information to assist the Department in seeking reimbursement for services provided; (2) Notifying the Department within 10 days if medical treatment has been provided as a result of any accident or other occurrence in which a third party may be liable for health care services provided to the recipient; and (3) Providing to the Department, as set forth in §J(2) of this regulation, the information required under such circumstances pursuant to COMAR 10.09.24.12 and Regulation .09B(1)(d) of this chapter. #### Regulation .13 Hearings. *COMAR 10.09.41.13* A. An EID applicant or recipient shall have the hearing rights specified in COMAR 10.01.04, subject to the qualification set forth in §B of this regulation. B. To apply the terms of COMAR 10.01.04 to the hearing rights of an EID applicant or recipient, substitute “the Department” for references therein to the “local department of social services”. ### Chapter 42 — Free-Standing Medicare-Certified Ambulatory Surgical Centers **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: September 2, 1991 (18:17 Md. R. 1918) **Administrative History:** Regulation .01B amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) **Administrative History:** Regulation .02B amended effective March 16, 2015 (42:5 Md. R. 485) **Administrative History:** Regulation .02C amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205) **Administrative History:** Regulation .03 amended effective March 16, 2015 (42:5 Md. R. 485) **Administrative History:** Regulation .03B amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .04C amended effective September 29, 2003 (30:19 Md. R. 1332); April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) **Administrative History:** Regulation .04D adopted effective March 16, 2015 (42:5 Md. R. 485) **Administrative History:** Regulation .05 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .05F amended effective March 16, 2015 (42:5 Md. R. 485) **Administrative History:** Regulation .06 amended effective April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 485) **Administrative History:** Regulation .06B amended effective April 12, 2004 (31:7 Md. R. 584) **Administrative History:** Regulation .06H amended effective July 4, 2016 (43:13 Md. R. 712) #### Regulation .01 Definitions. *COMAR 10.09.42.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Covered surgical procedures” means those surgical and other medical procedures which meet the criteria specified in 42 CFR Part 416, Subpart F, §416.166(a) and (b), and which are published by the Centers for Medicare and Medicaid Services (CMS) in the Federal Register. (2) “Dental Benefits Administrator (DBA)” means an entity that administers the dental program for the Maryland Department of Health. (3) “Dental services” means emergency, preventive, or therapeutic services for oral diseases which are administered by or under the general supervision of a dentist in the practice of the profession. (4) “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. (5) “Free-standing Ambulatory Surgery Center (ASC)” means an entity capable of providing ambulatory surgical services, which is not located in a hospital setting, and which is Medicare-certified to furnish ambulatory surgical services. (6) “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. (7) “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (8) “Medicare” means Medicare as defined in COMAR 10.09.36.01. (9) “Medicare-certified facility” means a facility which: (a) Is certified for Medicare by the regional office of the Centers for Medicare and Medicaid Services (CMS) to furnish ambulatory surgical services directly to patients; (b) Has an agreement with (CMS) under Medicare to participate as an ASC; and (c) Meets the conditions set forth by (CMS) in 42 CFR Part 416, Subparts B, C, and F, §416.163. (10) “Patient” means a recipient awaiting or undergoing health care or treatment. (11) “Physician” means an individual legally licensed to practice medicine in the state in which the physician's practice is located. (12) “Podiatrist” means a Doctor of Podiatry (D.P.M.) who is licensed to practice podiatry by the Board or by the state in which the service is rendered. (13) “Program” means Program as defined in COMAR 10.09.36. (14) “Provider” means a free-standing ambulatory surgical center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number. (15) “Recipient” means recipient as defined in COMAR 10.09.36.01. #### Regulation .02 License Requirements. *COMAR 10.09.42.02* A. License requirements under this chapter are referenced in COMAR 10.09.36.02. B. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of the Maryland Radiation Act, Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland, and meets the standards established by COMAR 26.12.01 and COMAR 26.12.02 or other applicable standards established by the state in which the service is provided. C. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and either COMAR 10.10.01 or 10.10.06, as applicable; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.42.03* A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03 and 42 CFR, Part 416, Subpart B. B. Specific requirements for participation in the Program are that the provider shall meet all specific conditions for participation as set forth in 42 CFR, Part 416, Subpart C, to include the following: (1) Be approved by Medicare to furnish ambulatory surgical services to patients and maintain documentation of certification by the Department of Health and Human Services and the Centers for Medicare and Medicaid Services; (2) Have clearly defined, written, patient care policies; (3) Maintain adequate documentation of each recipient visit as part of the plan of care, which at a minimum, shall include: (a) Date of service; (b) Recipient's reason for visit; (c) A brief description of service provided, and (d) A legible signature and printed or typed name of the professional providing care, with the appropriate title; (4) Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01; (5) Be approved by the state in which the service is provided, except where a Certificate of Need is not required; (6) Provide for in-house Program evaluation and clinical record review which assess use of services for appropriateness in meeting a recipient's needs; (7) Refer laboratory testing only to independent medical laboratory providers. #### Regulation .04 Covered Services. *COMAR 10.09.42.04* The Program covers the following: A. Medically necessary facility services rendered to recipients in a free-standing Medicare-certified ambulatory surgical center; B. Diagnostic, curative, palliative, or rehabilitative services, when clearly related to the recipient's individual needs; C. Surgical procedures which meet the standards described in 42 CFR Part 416, Subpart D, §416.65, and as published by the Centers for Medicare and Medicaid Services; and D. Dental services that have been pre-authorized by the Dental Benefits Administrator (DBA). #### Regulation .05 Limitations. *COMAR 10.09.42.05* The Program does not cover the following: A. Services not specified in Regulation .04 of this chapter; B. Services not medically necessary; C. Investigational and experimental drugs and procedures; D. Services denied by Medicare as not medically justified; E. Separate billing of services which are included in the composite Medicare rate for an ambulatory surgical center; F. Surgical procedures which: (1) Generally result in extensive blood loss; (2) Require major or prolonged invasion of body cavities; (3) Directly involve major blood vessels; (4) Are generally emergency or life-threatening in nature; (5) Commonly require systemic thrombolytic therapy; (6) Are designated as requiring inpatient care (overnight); (7) Can only be reported using a CPT unlisted surgical procedure code; or (8) Are otherwise excluded under 42 CFR §411.15(a)—(h) and (j)—(s); G. Physicians' services, including surgical procedures and all preoperative and postoperative services performed by a physician; H. Anesthesia services; I. Radiology services other than those integral to performance of a covered surgical procedure; J. Diagnostic procedures other than those directly related to a covered surgical procedure; K. Ambulance services; L. Leg, arm, back, and neck braces other than those that serve the function of a cast or splint; M. Artificial limbs; or N. Non-implantable prosthetic devices and durable medical equipment (DME). #### Regulation .06 Payment Procedures. *COMAR 10.09.42.06* A. The Program reimburses a facility fee when the free-standing Medicare certified ambulatory surgery center provides a covered surgical procedure, in accordance with 42 CFR §416.166 to an eligible Medicaid recipient. Reimbursement for the facility fee includes, but is not limited to the following: (1) Nursing, technician, and related services; (2) Use of the facility; (3) Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances, and any equipment directly related to the provision of surgical procedures; (4) Administrative costs; (5) Materials including supplies and equipment for the administration and monitoring of anesthesia; (6) Radiology services for which separate payment is not allowed and other diagnostic tests or interpretive services that are integral to a surgical procedure; (7) Supervision of the services of a nurse anesthetist by the operating surgeon; (8) Ancillary items and services that are integral to a covered surgical procedure as defined in 42 CFR §416.166; and (9) Any laboratory testing performed under a Clinical Laboratory Improvement Amendment of 1988 (CLIA) certificate of waiver. B. Reimbursement Methodology: (1) Reimbursement fees equal 80 percent of the current Medicare-approved ASC facility fee for services furnished to Medicaid recipients in connection with covered surgical procedures. (2) If one covered surgical procedure is furnished to a recipient, payment is at the Maryland Medicaid Program payment amount which is 80 percent of the current Medicare approved facility fee for that procedure. (3) If more than one covered surgical procedure is provided to a recipient in a single operative session, payment is made at 100 percent of the Maryland Medicaid Program payment amount for the procedure with the highest reimbursement rate. Other covered surgical procedures furnished during the same session are reimbursed at 50 percent of the Maryland Medicaid Program payment amount for each procedure. (4) When a covered surgical procedure is terminated before the completion due to extenuating circumstances or circumstances that threaten the well-being of the patient, the Medicaid Program payment amount is based on one of the following: (a) If the covered procedure for which the anesthesia is planned is discontinued after the induction of anesthesia or after the procedure is started, the reimbursement amount is 80 percent of the current Medicare approved facility fee; or (b) If the patient is prepared for surgery and the surgery is then cancelled before the induction of anesthesia, reimbursement shall be 50 percent of Maryland Medicaid payment amount. C. Dental services rendered in an ASC on or after December 1, 2014, shall be reimbursed as follows: (1) For covered dental services that have a reimbursement amount of $1,000 through $2,999.99, the ASC facility fee will be $600; (2) For covered dental services that have a reimbursement amount of $3,000 through $4,999.99, the ASC facility fee will be $1,250; (3) For covered dental services that have a reimbursement amount of $5,000 through $7,999.99, the ASC facility fee will be $2,500; and (4) For covered dental services that have a reimbursement amount of $8,000 and over, the ASC facility fee will be $3,000. D. The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. E. The Program reserves the right to return to the provider, before payment, all invoices not properly completed, including but not limited to, diagnostic and procedure codes and description of services provided. F. The Program shall authorize payment on Medicare cross-over claims only if: (1) The provider accepts Medicare assignment; (2) Medicare makes direct payment to the provider; and (3) Medicare has determined that the services are medically justified, excludes dental services. G. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: (1) Deductible is paid in full; (2) Coinsurance shall be paid lesser of: (a) 100 percent of the coinsurance amount; or (b) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of Regulation .04C of this chapter. H. The provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail or telephone; or (4) Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. I. The Program shall make no direct payment to a recipient. J. The Program shall make no separate direct payment to any person employed by or under contract to any free-standing Medicare-certified ambulatory surgical center facility for services covered under this regulation. K. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.42.07* Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.42.08* Causes for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.42.09* Appeal procedures under this chapter are set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.42.10* Interpretive regulations under this chapter are set forth in COMAR 10.09.36.10. ### Chapter 43 — Maryland Children's Health Program (MCHP) Premium **Authority:** Health-General Article, §§2-104(b), 15-101(f), 15-103(a)(2), 15-301.1, and 15-302—15-304;Insurance Article, §§15-1208, 15-1213, 15-1406, and 27-220;Annotated Code of Maryland; Ch. 202, Acts of 2003 **Administrative History:** Effective date: **Administrative History:** Regulations .01—.19 adopted as an emergency provision effective July 1, 2001 (28:12 Md. R. 1102); adopted permanently effective September 3, 2001 (28:17 Md. R. 1556) **Administrative History:** Regulation .02B amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .02B amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Regulation .03 amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .03 amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Regulation .04E amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .05A amended effective November 10, 2003 (30:22 Md. R. 1580); April 19, 2010 (37:8 Md. R. 614) **Administrative History:** Regulation .05F, G amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .09 amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .09 amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Regulation .10A and B amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .11 amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .12 amended as an emergency provision effective July 1, 2002 (29:16 Md. R. 1284); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .12 amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .13 amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .13A amended as an emergency provision effective July 1, 2004 (31:16 Md. R. 1251); amended permanently effective September 27, 2004 (31:19 Md. R. 1432) **Administrative History:** Regulation .14 amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .15D amended effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Chapter revised effective January 6, 2014 (40:26 Md. R. 2162) **Administrative History:** Regulation .10D adopted effective April 13, 2026 (53:7 Md. R. 328) **Administrative History:** Regulation .13F amended effective April 13, 2026 (53:7 Md. R. 328) #### Regulation .01 Purpose and Scope. *COMAR 10.09.43.01* This chapter governs the determination of eligibility and the conditions of participation for MCHP Premium with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014. #### Regulation .02 Definitions. *COMAR 10.09.43.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). (2) “Applicant” means a child or the child's representative who has filed a written, telephonic, or electronic application for health coverage in an Insurance Affordability Program to the Department or its designee but has not received final action. (3) “Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an Insurance Affordability Program to the Department or its designee. (4) “Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. (5) “Authorized representative” has the meaning stated in COMAR 10.01.04.12. (6) “Department” means the Maryland Department of Health. (7) “Designee" means any entity designated to act on behalf of the Department such as: (a) Baltimore City or a county social services department under the supervision of the Department of Human Services; (b) Baltimore City Health Department and its subgrantees, or a county health department; and (c) The Maryland Health Benefit Exchange (8) “Determination” means a decision regarding an applicant's eligibility for MCHP Premium. (9) “Eligible individual” means a child who meets all nonfinancial eligibility requirements to participate in MCHP under COMAR 10.09.11 and whose family income is above 200 percent but at or below 300 percent of the federal poverty level. (10) “Family contribution” means the portion of the premium cost paid for an eligible individual to enroll and participate in MCHP Premium. (11) “Family member” means an individual living with the applicant whose income is counted, or would be counted as family income under Regulation .07 of this chapter. (12) “Federal poverty level (FPL)” means the non-farm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981. (13) “Group health plan” has the meaning stated in 42 U.S.C. §300gg-91. (14) “Hardship” means unreasonable financial adversity or misfortune. (15) “Health insurance coverage” has the meaning stated in 42 U.S.C. §300gg-91. (16) “Inpatient services” means services received by a recipient while in a medical institution, birthing center, or clinic for which Medical Assistance is provided. (17) “Institution for mental disease (IMD)” has the meaning stated in COMAR 10.09.62.01B(78)(a). (18) “Insurance Affordability Program” means a program that is one of the following: (a) The Maryland State Medicaid program; (b) The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; (c) An optional State basic health program established under §1331 of the Affordable Care Act; (d) A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under §36B of the Internal Revenue Code; or (e) A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under §1402 of the Affordable Care Act. (19) “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. (20) “MAGI Exempt Coverage Group” means coverage groups such as Aged, Blind, Disabled; Categorically Needy; and Medically Needy as defined under COMAR 10.09.24.02, whose eligibility is not determined by MAGI. (21) “Managed care organization (MCO)” means: (a) A certified health maintenance organization that is authorized to receive Medical Assistance prepaid capitation payments; or (b) A corporation that: (i) Is a managed care system that is authorized to receive Medical Assistance prepaid capitation payments; (ii) Enrolls only program recipients, individuals, or families served under the Maryland Medicaid Managed Care Program; and (iii) Is subject to the requirements of Health-General Article, §15-102.4, Annotated Code of Maryland. (22) “Maryland Children's Health Program (MCHP)” means the program established in Health-General Article, §15-301(b)(1), Annotated Code of Maryland, to provide comprehensive medical care and other health care services to certain children. (23) “Maryland Health Benefits Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI based insurance affordability programs, including, by delegation, certain eligibility in the program. (24) “Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.09.62.01B(88). (25) “MCHP Premium” means the program established in Health-General Article, §15-301.1 et seq., Annotated Code of Maryland, to provide access to health coverage to eligible individuals through managed care organizations (MCOs) under MCHP. (26) “Medical institution” means an institution that: (a) Is organized to provide medical care, including nursing and convalescent care; (b) Has the necessary professional equipment and facilities to manage the medical, nursing, and other health needs of a patient on a continuing basis in accordance with accepted standards; (c) Is authorized under State law to provide medical care; and (d) Is staffed by medical and nursing professionals. (27) “Period under consideration” means the specific months that are assessed in order to determine eligibility for MCHP Premium. (28) Public Institution. (a) “Public institution” means an: (i) Institution that is the responsibility of a government unit or over which a government unit exercises administrative control; or (ii) Establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. (b) “Public institution” does not include a medical institution, a skilled nursing facility, or a publicly operated community residence that serves fewer than 17 residents. (29) “Qualified alien” means an individual who: (a) Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA); (b) Has been granted asylum in the United States as a refugee under §208 of the INA; (c) Has been admitted into the United States as a refugee under §207 of the INA; (d) Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year; (e) Has had deportation withheld under §243(h) of the INA; (f) Has been granted conditional entry into the United States under §203(a)(7) of the INA which was in effect before April 1, 1980; (g) Is a documented or undocumented immigrant who has been battered or subjected to extreme cruelty by the individual's U.S. citizen or lawful permanent resident spouse or parent, or by a member of the spouse's or parent's family residing in the same household as the alien, if: (i) The spouse or parent consented to, or acquiesced in, the battery or cruelty; (ii) The immigrant has filed a Violence Against Women Act (VAWA) immigration case or a family-based visa petition with INS; and (iii) In the opinion of the agency providing benefits, there is a substantial connection between the battery or cruelty and the need for the benefits to be provided; (h) Is a victim of a severe form of trafficking who has been subjected to: (i) Sex trafficking, if the act is induced by force, fraud, or coercion, or if the individual induced to perform the act is younger than 18 years old; or (ii) Involuntary servitude; (i) Is a member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or (j) Is an American Indian born in Canada to whom §289 of the Immigration and Nationality Act applies. (30) “Recipient” means a child younger than 19 years old who is certified as eligible for MCHP Premium. (31) “Redetermination” means a determination regarding the continuing eligibility of a recipient. (32) “Representative” means: (a) A parent or parents living with the applicant; (b) The applicant's guardian; or (c) The applicant's authorized representative. (33) “Title XXI” means the title of the Social Security Act through which funding is provided, in part, for MCHP Premium. #### Regulation .03 Coverage Groups. *COMAR 10.09.43.03* Eligibility may be established for the MCHP Premium Program for children younger than 19 years old whose household income is above 200 percent but at or below 300 percent of the Federal Poverty Level. #### Regulation .04 Application. *COMAR 10.09.43.04* A. The Department or its designee shall determine eligibility for children. B. The Department or its designee shall give oral, written, or electronic information about MCHP Premium such as: (1) Requirements for eligibility; (2) Available services; (3) An individual's rights and responsibilities; (4) Information in plain English, supported by translation services; and (5) Information accessible to disabled individuals requesting an application. C. An individual requesting health coverage from an Insurance Affordability Program shall be given an opportunity to apply. D. The Department or its designee shall make the application available to the individual without delay, by telephone, mail, in-person, internet, other available electronic means, and in a manner accessible to disabled individuals requesting an application. E. Applicant Temporarily Absent from the State. (1) If an applicant is temporarily absent from the State, the applicant or the applicant's representative may apply for assistance by telephone, mail, in person, internet, and other electronic means to the Department or its designee in any jurisdiction. (2) To establish eligibility for MCHP Premium for an applicant temporarily absent from the State, the applicant or the applicant's representative shall: (a) Affirm that: (i) The applicant intends to return to the State; or (ii) The applicant's parent or guardian intends to return the applicant to the State; (b) Demonstrate the applicant's continued residency in the State; and (c) Meet other technical and financial requirements. F. Application Filing and Signature Requirements. (1) An individual who wishes to apply for health coverage under Insurance Affordability Program shall submit a written, telephonic, or electronic application, signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant's choice. (2) A signed application is required for all applicants who request assistance. If, after the completion of an eligibility determination, assistance is requested for additional family members, a signed application is required for those persons. (3) The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee. (4) The following individuals shall complete and sign a written or electronic application: (a) An applicant; (b) An applicant’s parents living with the child applicant; or (c) If the applicant does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application form. G. An applicant who has filed a written, telephonic, or electronic application may voluntarily withdraw that application, but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §H of this regulation. H. Period Under Consideration. The Department or its designee shall establish a current period under consideration based on the date of application established under §F(3) of this regulation, for a 12-month period beginning with the month of application. I. Processing Applications — Time Limitations. (1) When a written, telephonic or electronic application is filed, a decision shall be made promptly, but not later than 60 calendar days from the application date. (2) The time period specified in §I(1) of this regulation covers the period from the application date to the date the Department or its designee sends a written or electronic notice of its decision to the applicant or the applicant's representative. (3) The Department or its designee shall inform the applicant by written or electronic notice of the missing information needed to determine eligibility, and the applicable time limit. (4) When an applicant fails to complete the application or to provide the required information needed to determine eligibility within the 60 calendar day limit provided under §I(1) of this regulation, the applicant shall be determined ineligible. (5) The Department or its designee shall provide notice of delay for extenuating circumstances within 60 calendar days of the delay, stating the reason for the delay and the anticipated date of decision. (6) If an applicant is determined ineligible for the current period under consideration due to a nonfinancial factor, the application shall be disposed of and the application date may not be retained. If the applicant reapplies, a new period under consideration shall be established based on the date the new application is filed. J. Information Required. (1) All information needed to determine eligibility for the MCHP Premium shall be reported. When there is evidence of inconsistency with attested information given by the applicant and reported by the state and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. (2) The applicant shall provide the additional information within a reasonable time limit as established by the Department. (3) If the applicant fails to provide required information within the 60 calendar days, the applicant shall be determined ineligible. K. Social Security Number. (1) As a condition of eligibility, an applicant shall furnish to the Department or its designee a Social Security number for the applicant. If the applicant cannot furnish a Social Security number, the applicant shall apply for a number. Assistance may not be denied, delayed, or discontinued pending the issuance or verification of the number if the applicant complies with this subsection. (2) Eligibility may not be established until the applicant: (a) Furnishes a Social Security number; or (b) Requests the assignment of the number through the Social Security Administration. (3) Failure to provide the required Social Security number shall result in ineligibility for the applicant. (4) If an applicant lacks the resources to meet the requirements of this regulation, the Department or its designee services shall assist the applicant in obtaining the necessary documents, and any costs incurred shall be paid for out of administrative funds. (5) If the application indicates that a Social Security number was issued previously, the Department or its designee shall request validation of the number by the Social Security Administration. L. Third-Party Liability. (1) An applicant shall notify the Department or its designee within 10 working days if medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party may be liable for the recipient's medical expenses. (2) An applicant shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. (3) In accident situations, a representative shall notify the Department or its designee of the: (a) Time, date, and location of the accident; (b) Name and address of the attorney; (c) Names and addresses of all parties and witnesses to the accident; and (d) Police report number if an investigation is made. M. Consent Forms. An applicant shall give consent to verify information to establish eligibility to the Department or its designee, by submitting a written, telephonic, or electronic application. #### Regulation .05 Nonfinancial Eligibility Requirements. *COMAR 10.09.43.05* A. Citizenship. In order to be eligible for full benefits under MCHP Premium, an applicant shall be one of the following: (1) A citizen of the United States; (2) A person residing in the United States who is: (a) A qualified alien as defined under Regulation .02B of this chapter; (b) An honorably discharged veteran of the armed forces of the United States; (c) An alien on active duty in the armed forces of the United States; or (d) The spouse, including a surviving spouse who has not remarried, or unmarried dependent child of an honorably discharged veteran of or alien on active duty in the armed forces of the United States; (3) An individual residing in the United States who is: (a) An alien who has been granted asylum under §208 of the Immigration and Nationality Act; (b) A refugee admitted into the United States under §207 of the Immigration and Nationality Act; (c) An alien whose deportation has been withheld under §243(h) of the Immigration and Nationality Act; (d) A Cuban or Haitian entrant; (e) An alien admitted to the country for permanent residence as an Amerasian immigrant under Title II of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1989; (f) A legal permanent resident who first entered the country under another exempt category, that is, as a refugee, asylee, Cuban or Haitian entrant, trafficking victim, or alien whose deportation was being withheld, and who later converted to legal permanent resident status; (g) A victim of a severe form of trafficking who has been subjected to: (i) Sex trafficking, if the act is induced by force, fraud, or coercion, or if the individual induced to perform the act is younger than 18 years old; or (ii) Involuntary servitude; (h) An honorably discharged veteran of the armed forces of the United States; (i) An alien on active duty in the armed forces of the United States; or (j) A spouse, including a surviving spouse who has not remarried, or unmarried dependent child of an honorably discharged veteran or alien on active duty in the armed forces of the United States; or (4) An individual residing in the United States who is a qualified alien as defined under Regulation .02B of this chapter. B. Residency. The requirements relating to residency under COMAR 10.09.24.05-3 apply to this chapter. C. Age. In order to be eligible for benefits, under this chapter a child shall be younger than 19 years old. D. Inmate of a Public Institution. In order to receive benefits under this chapter, an applicant may not be an inmate of a public institution. E. Institution for Mental Diseases or Mental Hospital. An applicant who is a patient in an institution for mental diseases or mental hospital is not eligible for benefits under this chapter. F. Access to or Coverage under Other Health Benefit Plans. (1) Current Coverage. Except for coverage purchased in the context of participating in MCHP Premium, an applicant or recipient is not eligible for MCHP Premium if the applicant or recipient is covered: (a) As a dependent under an employer-sponsored group health plan; or (b) Under health insurance coverage. (2) Past Coverage. In order to be eligible for benefits under this chapter, an applicant may not be covered by employer-sponsored insurance or have been voluntarily terminated from an employer-sponsored insurance within 6 months before the date of the application, except for coverage purchased in the context of participating in MCHP Premium. Voluntary termination does not include: (a) Loss of employment due to factors other than voluntary termination; (b) Change to a new employer that does not provide an option for dependent coverage; (c) Change of address so that no employer-sponsored health benefit plan is available; (d) Discontinuation of health benefits to all dependents of employees of the parent's or guardian's employer; or (e) Expiration of the applicant's continuation of coverage under the Consolidated Omnibus Budget Reconciliation Act (COBRA). G. Duration of Eligibility. After an individual has been determined to be eligible for MCHP Premium and is enrolled in MCHP Premium: (1) The Department shall periodically redetermine the recipient's eligibility for MCHP Premium as specified in Regulation .15D of this chapter; and (2) The recipient or the recipient's representative shall, within 10 days of the occurrence, notify the Department if there is a change in the recipient's, the recipient's parent's, or the recipient's guardian's: (a) Income; (b) Employment; (c) Address; or (d) Health insurance coverage status. #### Regulation .06 Consideration of Family Income. *COMAR 10.09.43.06* A. The applicant shall report the income of each family member, except for the income of members that do not file a federal tax return and are not claimed as a federal tax dependent. B. Determining Countable Household Income. (1) In determining an applicant's financial eligibility for MCHP Premium, the applicant's current household income shall be considered. (2) For the child applicant who is neither pregnant nor postpartum, household income shall consist of the income of the applicant and the applicant's parent or parents, if living with the applicant. (3) For the married child applicant, household income shall consist of the income of the married child applicant and the married child applicant's spouse. C. When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application. D. Treatment of Income. (1) Countable gross income for the Maryland Children’s Health Program shall be the household income calculated according to MAGI. (2) MAGI income limits shall be: (a) Converted from traditional income limits to account for elimination of income disregards; and (b) Increased by 5 percentage points of the federal poverty level for the following circumstances: (i) When an individual’s income exceeds the Medicaid income standard; and (ii) The income standard is the highest income standard under which the individual can be determined eligible. (3) Household Composition. For purposes of determining the income standard applicable to an applicant the following rules apply: (a) An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made. (b) For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: (i) Spouse; and (ii) Natural, adopted or step children. (c) In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals: (i) Natural, adopted, or step parents; and (ii) Natural, adopted, or step siblings. (d) In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made. (4) No resources or assets test may be applied to applicants or recipients who are subject to a MAGI-based income test. #### Regulation .07 Consideration of Family Income: Earned and Unearned Income — Repealed. *COMAR 10.09.43.07* #### Regulation .08 Consideration of Family Income: Income Disregards — Repealed. *COMAR 10.09.43.08* #### Regulation .09 Determining Financial Eligibility. *COMAR 10.09.43.09* Current and New Enrollees. An applicant is financially eligible for MCHP Premium if, for the period under consideration, the applicant's countable household income as determined under Regulation .06 of this chapter, is greater than 200 percent but not greater than 300 percent of the federal poverty level for the number of persons in an applicant’s tax-dependent unit equal to the size of the applicant's family. #### Regulation .10 Certification Periods. *COMAR 10.09.43.10* A. The certification period begins the first day of the month in which the eligible child is enrolled in a MCO. B. Duration of Certification Period. (1) The initial certification period, or the certification period beginning after a period of ineligibility for MCHP Premium, shall end not later than 1 year from the beginning month of certification for MCHP Premium. (2) Notwithstanding §B(1) of this regulation, the certification period may be shortened: (a) If a determination of ineligibility is made; or (b) At the request of the representative. C. A child who, on the day the child becomes 19 years old, is receiving acute inpatient services under MCHP Premium and who, but for attaining that age, is otherwise eligible for MCHP Premium, shall remain eligible for MCHP Premium until the end of the stay for which acute inpatient services are furnished. D. Individuals may be certified for a period of continuous eligibility as described in COMAR 10.09.24.12. #### Regulation .11 Covered Services. *COMAR 10.09.43.11* A child enrolled in MCHP Premium is eligible for all health benefits included in the Maryland Medicaid Managed Care Program, as set forth in COMAR 10.09.67, the school-based health centers program as set forth in COMAR 10.09.68, and the rare and expensive case management. #### Regulation .12 Program Participation Requirements — Enrollment. *COMAR 10.09.43.12* A. An eligible individual who is enrolled in MCHP Premium shall be covered through a Maryland Medicaid Managed Care MCO. B. Timely Enrollment. The representative shall: (1) Send to the Department or its designee the first month's family contribution within 30 days of receiving notice of eligibility for MCHP Premium, before enrollment can be completed; and (2) Complete and submit to the Department's enrollment broker a MCO selection and enrollment form within 28 days of receiving notice of eligibility for each eligible child. #### Regulation .13 Program Participation Requirements — Family Contribution. *COMAR 10.09.43.13* A. Family Contribution Required. As a requirement of enrollment and participation in MCHP Premium, the representative of an eligible individual shall agree to pay the following annual family contribution: (1) For an eligible individual whose family income is above 200 percent but at or below 250 percent of the FPL, an amount equal to 2 percent of the annual income of a family of two at 200 percent of the FPL; and (2) For an eligible individual whose family income is above 250 percent, but at or below 300 percent of the FPL, an amount equal to 2 percent of the annual income of a family of two at 250 percent of the FPL. B. The family contribution amounts required under §A of this regulation apply on a per family basis regardless of the number of eligible individuals each family has enrolled in MCHP Premium. C. American Indians and Alaskan Natives are exempt from a family contribution requirement. D. Payment Procedures. (1) The representative shall send the initial month's payment to the Department or its designee by electronic transfer, money order, or check. (2) For months following the initial month of coverage: (a) The Department or its designee shall bill at the start of each month for the next month's family contribution and shall provide a self-addressed stamped envelope for return of the family contribution; (b) The representative shall make the family contribution payment in full to continue coverage, unless the representative claims that payment will cause hardship as defined in Regulation .02B of this chapter; (c) The Department or its designee shall notify the applicant of the amount due and instruct on the manner of payment and date due, if timely payment has not been made; and (d) The applicant shall make payment in full of amounts due to the Department or its designee no later than 30 days after the date of issuance of a request for payment, to ensure continuing eligibility unless the representative claims that payment will cause hardship as defined in Regulation .02B of this chapter. E. Hardship. (1) The applicant shall submit the claim of hardship in writing within 10 days of receipt of the Department's request for payment. (2) The Department shall evaluate claims of hardship and notify the applicant of the decision within 30 days of receipt of the written claim of hardship. #### Regulation .14 Program Participation Requirements — Change in Status. *COMAR 10.09.43.14* A. The applicant shall report any change in family status or family composition within 10 days of the change. B. Change in family status includes increase or decrease in the number of family members through birth, death, marriage, adoption, separation, divorce, or the voluntary or involuntary removal of a family member from residence with the family. C. The applicant shall complete a written, telephonic, or electronic application and file it with the Department or its designee in any jurisdiction to apply for coverage for a child added to the family, including a newborn child, unless the newborn child's mother was eligible for Medicaid when the child was born. D. For all changes except addition of a child, the Department or its designee shall evaluate the effect of the change on continued eligibility for MCHP Premium and notify the applicant of its determination within 60 days of the report of the change. #### Regulation .15 Post-Eligibility Requirements. *COMAR 10.09.43.15* A. Notice of Eligibility Determination. The Department or its designee shall inform the applicant of the applicant's legal rights and obligations and give the applicant written or electronic notification of the following: (1) For eligible individuals: (a) The basis and effective date for eligibility; (b) Instructions for reporting changes that may affect the recipient’s eligibility; and (c) The right to request a hearing; and (2) For ineligible individuals: (a) A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; (b) Information regarding application for MAGI excluded coverage groups; and (c) The right to request a hearing. B. Applicant Responsibility. (1) The applicant shall notify the Department within 10 working days of changes affecting the applicant’s eligibility. (2) Only an applicant that has been determined eligible by the Department or its designee shall use MCHP Premium benefits. (3) If written or electronic notice of cancellation is received, the applicant shall discontinue use of MCHP Premium benefits on the first day of ineligibility. (4) Failure to comply with the provisions of §B(1)—(3) of this regulation may result in: (a) The termination of assistance; or (b) Referral to the Department for fraud investigation, or for criminal or civil prosecution. (5) The applicant shall cooperate with the Department’s quality control review process, including verification of all information pertinent to the determination of eligibility. (6) If the applicant refuses to cooperate, the applicant’s coverage shall be terminated. C. Unscheduled Redetermination. (1) The Department shall: (a) Promptly make an unscheduled redetermination of a recipient's eligibility if changes in circumstances or relevant facts are: (i) Reported by someone on the applicant’s behalf; or (ii) Brought to the attention of the Department from other responsible sources; and (b) Notify the applicant of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. (2) Eligibility Decisions. Recipients who are determined: (a) Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or (b) Ineligible for the remainder of the certification period because of a change in circumstances or failure to establish eligibility following a change in circumstances, shall be sent notice in accordance with §A(2) of this regulation. (3) A recipient whose eligibility has been canceled may reapply for MCHP at any time. D. Scheduled Redetermination. (1) Redetermination is required to establish continued eligibility. (2) Redetermination shall be scheduled annually. (3) Completion of the application and determination of eligibility for MCHP by the Department or its designee is required for renewal for program eligibility. #### Regulation .16 Hearings. *COMAR 10.09.43.16* The requirements relating to hearings under COMAR 10.01.04 apply to this chapter. #### Regulation .17 Fraud, Abuse, and Penalty. *COMAR 10.09.43.17* A. The requirements relating to fraud and recipient abuse under COMAR 10.09.24.14 apply to this chapter. B. A person convicted of fraud under this chapter is subject to penalties as described in Criminal Law Article, §§8-516 and 8-517, Annotated Code of Maryland. #### Regulation .18 Adjustments and Recoveries. *COMAR 10.09.43.18* In all cases where MCHP Premium benefits have been incorrectly paid, the Department shall seek recovery pursuant to COMAR 10.09.24.15. #### Regulation .19 Interpretive Regulation. *COMAR 10.09.43.19* State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services for MCHP Premium recipients without regard to the availability of federal financial participation. ### Chapter 44 — Programs of All-Inclusive Care for the Elderly (PACE) **Authority:** Health-General Article, §2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.25 adopted as an emergency provision effective November 1, 2002 (29:25 Md. R. 1979); adopted permanently effective April 28, 2003 (30:8 Md. R. 540) **Administrative History:** Regulation .01B amended effective October 14, 2013 (40:20 Md. R. 1652); August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .03 amended effective January 29, 2018 (45:2 Md R. 68); July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .04 amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .05A, B amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .06 amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .07 amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .09B amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .11E amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .12 amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .15 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .16A amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .18F amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .20A amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .21 amended effective August 19, 2024 (51:16 Md, R. 742); July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .22 amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .23 amended effective August 19, 2024 (51:16 Md, R. 742) **Administrative History:** Regulation .23B amended effective July 21, 2025 (52:14 Md. R. 713) **Administrative History:** Regulation .24C amended effective July 21, 2025 (52:14 Md. R. 713) #### Regulation .01 Definitions. *COMAR 10.09.44.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Amount that would otherwise have been paid (AWOP)” means the amount the Program expects to have paid for services for a PACE participant under the State Plan had the participant not enrolled under the PACE program. (2) “Community spouse” means an individual who: (a) Lives in the community outside a long-term care facility; (b) Is not determined to meet the criteria for participation for: (i) PACE under this chapter; or (ii) A waiver under §1915(c) of the Social Security Act; and (c) Is married to an institutionalized spouse. (3) “Continuous period of institutionalization” means at least 30 consecutive days of institutional care in a long-term care facility. (4) “Contract” means a written agreement between a PACE provider and a third party under which the third party agrees to perform one or more of the PACE provider's obligations under this chapter or the PACE agreement. (5) “Capitation payment” means the sum of money paid in advance on a monthly per capita basis to a PACE provider by the Department on a participant's behalf for the PACE provider benefit package specified in the PACE Program Agreement. (6) “Centers for Medicare and Medicaid Services (CMS)” means the federal administering agency for the Medicare and Medicaid program benefits in PACE. (7) “Contractor” means an entity with which the PACE provider has a contract agreement. (8) “Contract year” means the term of a PACE Program Agreement, which is a calendar year, except that a PACE provider's initial contract year may be from 12 to 23 months, as determined by CMS. (9) “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01B, or its authorized agents acting on its behalf. (10) “Eligible person” means any person who meets the eligibility requirements for enrollment in the PACE program as specified in the PACE program agreement and Regulation .05 of this chapter. (11) “Emergency medical condition” means a medical condition characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate attention could reasonably be expected by a prudent lay person, who possesses an average knowledge of health and medicine, to result in: (a) Placing the individual's health in serious jeopardy; (b) Serious impairment to bodily functions; or (c) Serious dysfunction of any bodily organ or part. (12) “Emergency services” means health care services that are: (a) Covered under the PACE provider benefit package; (b) Provided to a PACE participant with an emergency medical condition; (c) Rendered by entities who are not employees or agents of the PACE provider and with whom the PACE provider does not have a contract; and (d) Provided in a hospital emergency facility or a free-standing urgent care center as defined in COMAR 10.09.77.01. (13) “Insolvency” means that the entity's net tangible equity or fund balance is negative and results from total program expenditures exceeding total program revenues to date. (14) “Institutionalized spouse” means an individual who is married to a community spouse and who is: (a) An inpatient in a long-term care facility with a length of stay exceeding 30 days; or (b) Determined to meet the criteria for participation for: (i) PACE under this chapter; or (ii) A waiver under §1915(c) of Title XIX of the Social Security Act. (15) “Long-term care facility” means a nursing facility, intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID), chronic hospital, tuberculosis hospital, or psychiatric hospital. (16) “Medicaid Provider Agreement” means the agreement between Medicaid providers, including PACE providers, and the Department that allows providers to provide services to Medicaid participants (17) “Medical Assistance Program” means the Maryland Medical Assistance Program, as defined in COMAR 10.09.36.01B. (18) “Medically necessary” means directly related to diagnostic, preventive, curative, palliative, or rehabilitative treatment. (19) “Medicare” means the federal program that provides benefits to aged or disabled individuals under Title XVIII of the Social Security Act. (20) “PACE enrollment limit” means the maximum number of Medicaid participants permitted to the PACE provider as declared in the State Certification Page of the CMS PACE provider application. (21) “PACE benefit package” means a prepaid, comprehensive package of all the health care services to which a PACE provider's participants are entitled under the State Plan when the services are medically necessary and appropriate. (22) “PACE center” means a facility operated by a PACE provider where primary care is furnished to participants. (23) “PACE Organization Provider Agreement” is the agreement between the PACE Provider and the Department that contains provisions to provide additional protections to PACE participants. (24) “PACE participant” means an eligible person who voluntarily enrolls and enters into an agreement with a PACE provider or an eligible person who is enrolled by a legal representative. (25) “PACE provider” means an entity that is approved by the Department and CMS to provide the PACE benefit package covered under this chapter to Medical Assistance participants. (26) “PACE Program Agreement” means a written, signed agreement between the Department, CMS, and the PACE provider, which specifies the terms of the relationship between the Department and the PACE provider and authorizes the PACE provider to operate in the State. (27) “Participant” means an individual who is certified by the Department as eligible to receive Medical Assistance Program benefits. (28) “Primary care” means health care services that address an individual's general health needs, including the coordination of the individual's health care, with the responsibility for the prevention of disease, promotion and maintenance of health, treatment of illness, maintenance of the individual's health records, and referral for medically necessary and appropriate specialty care. (29) “Primary care provider” means a practitioner who provides a participant's primary care services and is the primary coordinator of all other health care services for the participant, responsible for providing or assuring access to continuous, comprehensive, and coordinated health care services covered in the PACE benefit package. (30) “Professional standards” means professional requirements set forth in the Annotated Code of Maryland or by the national accrediting body for a practitioner's profession. (31) “Program” means the Medical Assistance Program, as defined in COMAR 10.09.36. (32) “Programs of All-Inclusive Care for the Elderly (PACE)” means a jointly administered capitated Medicare/Medicaid program providing medical and long term care services to nursing home eligible, frail, elderly participants. (33) “Quality Assurance and Performance Improvement Plan (QAPI)” means a document or series of documents that set forth a PACE provider's strategy for systematically monitoring, evaluating, and improving all facets of operations including, but not limited to, clinical health care delivery, participant assistance and outreach services, and administrative services. (34) “Secretary” means the Secretary of Health. (35) “Service area” means a defined geographic area selected by the PACE provider and approved by the Department in the PACE program agreement, in which the complete PACE benefit package is available to all the PACE provider's participants, and beyond which the PACE provider is restricted from directly marketing its services. (36) “Services” includes both items and services. (37) “State Plan” means the plan for the Medical Assistance Program as submitted by the Department and approved by the Secretary of the U.S. Department of Health and Human Services pursuant to Title XIX of the Social Security Act, as modified or amended. (38) “Trial period” means the first 3 contract years in which a PACE organization operates under a PACE program agreement, including any contract year during which the entity operated under a PACE demonstration waiver program. (39) “Urgent care” means health care services for a medical condition that manifests itself by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent layperson who possesses an average knowledge of health and medicine, to result in an emergency medical condition. #### Regulation .02 Application for Qualification as a PACE Provider. *COMAR 10.09.44.02* An applicant for participation in the Program as a PACE provider shall submit to the Department and CMS a complete PACE application that describes how the entity meets all requirements in 42 CFR 460 et seq. #### Regulation .03 PACE Provider. *COMAR 10.09.44.03* A. The PACE provider shall comply with: (1) 42 CFR 460 et seq.; (2) This chapter; (3) The Medicaid provider agreement and the PACE Organization Provider Agreement signed with the Department; (4) COMAR 10.09.36; (5) Standards in P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; (6) Any other applicable regulations, transmittals, and guidelines issued by the Department that are in effect; and (7) All other requirements of applicable federal and State law. B. The PACE provider shall have a signed PACE program agreement with the Department and CMS which establishes the terms of the relationship between the PACE provider and the Department. C. The PACE provider shall obtain approval by the Department before establishing additional care sites. D. The PACE provider shall obtain approval by the Department before expanding its service area. E. Professional and Administrative Standards. The PACE provider shall have the professional and administrative ability and staffing to carry out its duties and responsibilities according to the PACE Program Agreement and PACE Organization Provider Agreement, which shall include the following: (1) A full-time administrator; (2) Sufficient allied health, medical social work, clerical, and support staff to provide proper medical care within acceptable professional standards; (3) A demonstrated ability to deliver health services within the service area according to standards established by the Department; (4) A management information system, which shall: (a) Meet the requirements of Regulations .14 and .15 of this chapter; and (b) Maintain medical and financial records for 10 years; (5) An acceptable PACE participant grievance and appeals procedure and system for reporting the disposition of grievances and appeals to the Department, as specified in Regulation .19 of this chapter; (6) A procedure established to provide PACE participants an ability to participate in matters of policy and operation; and (7) A sufficient quality assurance and performance improvement system, as specified in Regulation .13 of this chapter. F. Nondiscrimination. In connection with the performance of its obligations under this chapter, the PACE provider shall comply with all applicable federal and State laws, regulations, or orders which prohibit discrimination on grounds of race, age, creed, sex, color, national origin, marital status, physical or mental handicap, health status, or need for health services. G. Provision of Services and Health Care Delivery. A PACE provider shall provide: (1) The services set forth in Regulation .09 of this chapter and covered under the PACE provider benefit package: (a) Promptly and continuously, consistent with accepted medical practice and community professional standards; and (b) Through its own employees and agents or through contractors, except for emergency services; and (2) Written notice to PACE participants if there is a significant change in the nature, location, or provider of services provided. H. The PACE provider may not knowingly have as a director, officer, partner, or owner of more than 5 percent of the entity's equity, a person or an affiliate of a person who is or has been debarred, suspended, or otherwise excluded from participating in procurement activities under the Federal Acquisition Regulation or from participating in nonprocurement activities under regulations issued pursuant to federal Executive Order No. 12549 or under guidelines implementing such an order. I. The PACE provider may not knowingly have an employment, consulting, or other agreement with a person described in §H of this regulation, for the provision of items and services that are significant and material to the PACE provider's obligations under this chapter. J. The PACE provider and its agents and employees, in the performance of the services covered under this chapter, shall act in an independent capacity and may not act as officers, employees, or agents of the Department. K. An individual employed by the State or any department, commission, agency, or branch of the State, whose duties include matters relating to or affecting the subject matter of this chapter, may not be an employee of a PACE provider. L. Any obligations of the PACE provider set forth in this chapter may be waived by the Department, but the waiver extends only to the particular case, time, and manner specified by the Department and is not a waiver of any other provision of this chapter. M. If the PACE Program Agreement exempts the PACE provider from financial responsibility for any services available under the State Plan, the PACE provider shall be required by the PACE Organization Provider Agreement to provide for these services. N. Liability. (1) The PACE provider shall be wholly at risk for all medically necessary and appropriate services covered under the PACE provider benefit package. (2) The Department may not make additional payment for services under this section. (3) The PACE provider may not collect any payment from a PACE participant except as specified in Regulation .05 of this chapter. (4) The PACE provider is solely responsible for ensuring that it does not issue payments for services for which it is not liable in its PACE Organization Provider Agreement, and the Department may not accept responsibility for refunding to the PACE provider any excess payments made by the PACE provider. #### Regulation .04 Term of the PACE Organization Provider Agreement. *COMAR 10.09.44.04* A. The duration or term of the agreement between the Department and the PACE provider is specified in the PACE Organization Provider Agreement. B. The PACE Organization Provider Agreement shall provide for automatic amendment, renegotiation, or termination, or all of the above, of the PACE Organization Provider Agreement by either party if any part of the PACE Organization Provider Agreement's provider benefit package is changed under the State Plan. C. Termination. (1) The Department may terminate immediately the PACE Organization Provider Agreement upon notification: (a) By the U. S. Department of Health and Human Services, that it is withdrawing federal financial participation in all or part of the cost of the PACE benefit package; (b) By the Department of Budget and Management, of the unavailability of sufficient State funds for the PACE benefit package; or (c) That the owners or managers of the PACE provider, or other persons with substantial Medicaid Provider Agreement relationships with the PACE provider, have been convicted of certain crimes or received certain sanctions as specified in §1128 of the Social Security Act. (2) The Department may, at its sole discretion, offer to renegotiate any provision of the PACE Organization Provider Agreement if renegotiation would remove any of the causes of termination specified in §C(1) of this regulation. This offer is not a waiver of the Department's right of immediate termination. (3) The PACE Organization Provider Agreement may be terminated by either the Department or the PACE provider if the other party fails to meet a provision of: (a) This chapter; (b) The PACE Organization Provider Agreement; or (c) Applicable laws, rules, regulations, or guidelines effective as of the date of the PACE Organization Provider Agreement or enacted or established during the PACE Organization Provider Agreement's term. (4) A PACE Organization Provider Agreement's termination is effective only after the terminating party has notified the breaching party in writing of the cause or causes of termination and has allowed 60 days for the correction or alleviation of the cause or causes by the breaching party. (5) Termination of Agreement by PACE. The PACE provider may terminate an agreement after timely notice to CMS, the Department, and PACE participants, as follows: (a) To CMS and the Department, 90 days before termination; and (b) To PACE participants, 60 days before termination. D. Default by PACE. (1) The Department may immediately terminate the PACE Organization Provider Agreement if the PACE provider defaults, as specified in §D(3) of this regulation. (2) If the PACE provider defaults, the Department may recover any capitation payments issued to the PACE provider for periods after the termination effective date of the PACE Organization Provider Agreement. (3) The following are defaults by the PACE provider: (a) Inability to provide the services described in the PACE provider benefit package and in Regulation .09 of this chapter; or (b) Insolvency. E. Nonexclusivity of Remedy. (1) This regulation's provisions supplement, rather than replace, any other sanctions or remedies available to the Department under the provisions of Regulation .24 of this chapter, the PACE Organization Provider Agreement, the Medicaid Provider Agreement, or applicable law or regulations. (2) If the PACE Program Provider Agreement is terminated under this regulation, the PACE provider shall furnish to the Department, within 45 days of the termination's effective date, all information necessary for the reimbursement of any outstanding claims for services rendered to the PACE provider's participants, including claims of its contractors. #### Regulation .05 PACE Participant Eligibility. *COMAR 10.09.44.05* A. An eligible person shall: (1) Reside in the PACE approved service area upon enrollment; (2) Be 55 years old or older; (3) Be able to be maintained in a community-based setting with the assistance of PACE at the time of enrollment without jeopardizing the PACE participant's health or others' health or safety; (4) Be determined by the Department to need the level of care required under the State Plan for coverage of nursing facility services for longer than 4 months; and (5) Be willing to abide by the provision that requires PACE participants to receive all health and long-term care services exclusively from the PACE provider and its contracted or referred providers. B. Medical Assistance Eligibility Services. (1) Medical Assistance eligibility for services under this chapter is determined under this regulation and applicable sections of COMAR 10.09.24, as cited in §B(2)—(4) of this regulation. (2) Categorically Needy. An individual is eligible for services under this chapter as categorically needy if the individual is receiving Medical Assistance as: (a) A recipient of Supplemental Security Income (SSI); (b) A member of a low income family with children, as described in §1931 of the Social Security Act; or (c) Any other type of categorically needy person in accordance with COMAR 10.09.24.03. (3) Optionally Categorically Needy. (a) An individual is eligible for services under this chapter as optionally categorically needy in accordance with 42 CFR §435.217, if the individual's countable: (i) Income does not exceed 300 percent of the applicable payment rate for SSI; and (ii) Resources do not exceed the SSI resource standard for one individual. (b) For the purpose of determining Medical Assistance eligibility for the optionally categorically needy: (i) The individual is treated as an assistance unit of one individual; and (ii) Countable income and resources are determined based on the rules for income and resources set forth in COMAR 10.09.24 as applicable to an aged, blind, or disabled individual who is institutionalized, with the exceptions in §B(3)(g) of this regulation. (c) An individual is not eligible under §B(3) of this regulation if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires. (d) The spousal impoverishment rules in §1924 of the Social Security Act and COMAR 10.09.24.10-1 are applicable, except for the differences specified in this regulation. (e) Medical Assistance eligibility shall be redetermined at least every 12 months. (f) If the applicant or participant is not aged, blind, or determined disabled by the Social Security Administration, the Department of Human Services shall determine whether the applicant or participant is technically eligible for Medical Assistance as a disabled person, in accordance with COMAR 10.09.24.05-4B. (g) All provisions of COMAR 10.09.24 which apply to an aged, blind, or disabled individual who is institutionalized are applicable to applicants and PACE participants under this chapter who are considered optionally categorically needy, with the following exceptions in full or in part: (i) COMAR 10.09.24.04-1D and E; (ii) COMAR 10.09.24.04-1F; (iii) COMAR 10.09.24.06B(2)(a)(ii); (iv) COMAR 10.09.24.08F(1); (v) COMAR 10.09.24.08G; (vi) COMAR 10.09.24.09; (vii) COMAR 10.09.24.10; and (viii) COMAR 10.09.24.10-1. (h) Home Exclusion. The home, as defined in COMAR 10.09.24.08F(1), is not a countable resource under §B(3) of this regulation if it is occupied by the applicant or PACE participant, the applicant's or PACE participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or PACE participant: (i) Child; (ii) Parent; or (iii) Sibling. (i) Medical Assistance eligibility shall be determined by the Department within 45 days after the Department or its representative receives a signed application according to COMAR 10.09.24.04-1D. (4) Post-Eligibility Determination of Available Income for Optionally Categorically Needy. (a) The countable monthly income considered for the post eligibility determination is calculated in accordance with §B(3) of this regulation and COMAR 10.09.24 for institutionalized aged, blind, or disabled individuals, except that the income disregards specified in COMAR 10.09.24.07L are not applied. (b) For individuals eligible under §B(3) of this regulation who reside in a licensed assisted living facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: (i) A personal needs allowance of $60; (ii) A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d); and (iii) Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g). (c) For individuals who reside in an assisted living facility whose contribution toward the cost of service is calculated under §B(4)(b) of this regulation, the provider shall collect the PACE participant's available income. The amount collected under this paragraph may not exceed the monthly capitation amount under this chapter for the PACE participant. (d) For individuals eligible under §B(3) of this regulation who reside in a long-term care facility, the Department shall calculate a client contribution towards the cost of services under this chapter, based on the amount remaining after deducting from the individual's countable monthly income the following amounts in the following order: (i) A personal needs allowance in accordance with COMAR 10.09.24.10D(2)(c); (ii) A spousal or family maintenance allowance in accordance with COMAR 10.09.24.10D(2)(d); (iii) A residential allowance in accordance with COMAR 10.09.24.10D(2)(e); and (iv) Incurred medical expenses as specified in COMAR 10.09.24.10D(2)(f) and (g). (e) For individuals who reside in a long-term care facility whose contribution toward the cost of service is calculated under §B(4)(d) of this regulation, the provider shall collect the PACE participant's available income. C. Enrollment shall be on a voluntary basis, without respect to race, age greater than the lower limit required, creed, sex, color, national origin, marital status, or physical or mental handicap. D. An individual is not eligible for enrollment in PACE, regardless of whether the individual is otherwise eligible for benefits under the Program, if the individual is: (1) Living outside the PACE provider's service area; (2) Not included in the PACE provider's target population specified in the PACE Program Agreement; or (3) Enrolled in: (a) A managed care organization contracting with the Department; (b) A Medicaid home and community-based services waiver under §1915(c) of the Social Security Act; (c) Rare and expensive case management (REM) under COMAR 10.09.69; or (d) A Medicaid capitated program that includes nursing facility or community-based long term care services. #### Regulation .06 Pace Participant Enrollment. *COMAR 10.09.44.06* A. The Department shall enroll eligible persons who have chosen to enroll in the PACE provider. B. The PACE provider shall enter into an enrollment agreement with an eligible participant on the form approved by the Department. C. The PACE provider shall enroll eligible participants in the order in which they apply, and may not discriminate on the basis of health status in its enrollment, re-enrollment, or disenrollment procedures. D. Signature on Enrollment Forms. (1) Except as indicated under §D(2) of this regulation, a participant 55 years old or older shall sign and submit the enrollment form; (2) A legal guardian or legal representative shall sign enrollment forms for eligible persons determined to be incapacitated or incompetent to sign the form. E. Because the PACE provider is responsible for ensuring that participants whose primary language is not English understand the benefits and restrictions associated with enrollment in PACE, the PACE provider shall give to such a participant at the time of enrollment a: (1) Notice that translation services are available; or (2) List of primary care providers who speak foreign languages. F. Subject to verification of eligibility, enrollment shall be effective on the first day of the calendar month following the date the PACE organization receives the signed enrollment agreement. G. An individual eligible for enrollment under Regulation .05 of this chapter, may enroll at any time during the term of the PACE Provider Agreement, unless: (1) Enrollment under the PACE Organization Provider Agreement has been suspended pursuant to Regulation .23 of this chapter; or (2) The PACE provider exceeds the enrollment limit established by the Department. H. The PACE provider shall: (1) Maintain a list of all individuals denied enrollment in the order in which they applied for enrollment; and (2) Promptly offer enrollment to denied individuals when permitted. I. The PACE provider shall provide to each PACE participant an identification card, clearly indicating the bearer is enrolled with the PACE provider. J. The PACE provider shall provide in writing and explain to a new participant, at a minimum, the following: (1) Notification of the PACE participant's right to terminate enrollment, the time frame required, and explanation of the required process; and (2) Information about the proper utilization of pharmacy services including the requirement to use one pharmacy within the PACE provider network to fill all prescriptions. #### Regulation .07 Termination of PACE Participant's Enrollment. *COMAR 10.09.44.07* A. Termination of a PACE participant's enrollment may be initiated by the: (1) PACE provider; (2) Department; (3) PACE participant; or (4) PACE participant’s legal guardian or legal representative. B. All enrollment terminations require prior approval by the Department. C. General Requirements for Processing Disenrollments. (1) The Department shall establish a timeline for the receipt of disenrollment forms as follows: (a) A PACE participant’s involuntary disenrollment occurs after the PACE provider meets the requirements set forth in 42 CFR §460.164 and is effective on the first day of the next month that begins 30 days after the day the PACE organization sends notice of the disenrollment to the PACE participant; or (b) A PACE participant’s voluntary disenrollment is effective on the first day of the month following the date the PACE organization receives the PACE participant’s notice of voluntary disenrollment. (2) Disenrollment requests shall be submitted to the Department by the PACE provider within 3 working days from completion, except if the PACE participant requests that the form be mailed to the PACE participant's home address for completion. (3) The PACE provider shall send the PACE participant a copy of the completed disenrollment forms, regardless of who initiated the disenrollment process. D. Voluntary Disenrollment by PACE Participant. (1) In general, PACE participants may disenroll from the PACE provider at their discretion at any time without cause, by completing or having completed by a legal guardian or legal representative a disenrollment form provided by the Department. (2) The PACE provider shall act to facilitate disenrollment, including mailing disenrollment request forms to PACE participants desiring to disenroll but having difficulty accessing the PACE provider's office. (3) The PACE provider shall date-stamp PACE participants' disenrollment requests upon receipt. E. Disenrollment Initiated by the PACE Provider. (1) The PACE provider shall have a written policy regarding termination of a PACE participant's enrollment by the PACE provider which shall address, at a minimum: (a) Under what conditions a PACE participant is to be disenrolled by the PACE provider; and (b) The time elements involved in processing terminations. (2) A disenrollment initiated by the PACE provider shall require prior approval by the Department. (3) A disenrollment may not occur because of an adverse change in the PACE participant's health status. (4) The PACE participant's complete medical and utilization history shall be provided by the PACE provider to the Department, upon request, in order to determine an appropriate disenrollment date. (5) The PACE provider shall notify the PACE participant within 14 days of when the disenrollment is approved, and the PACE participant may appeal the decision under the terms of COMAR 10.01.04. (6) Disenrollment may be requested by the PACE provider by providing to the Department acceptable documentation that the: (a) PACE participant's domicile was relocated outside the PACE provider's service area; (b) PACE participant is no longer eligible in accordance with Regulation .05 of this chapter; (c) PACE participant is discovered to be an individual for whom there existed legal documentation at the time of enrollment that the individual was mentally incompetent, but the PACE participant signed the enrollment form; (d) PACE participant commits fraudulent or illegal acts, such as permitting use of the PACE participant's medical identification card by others, altering a prescription, theft or other criminal acts committed in any provider's or PACE provider's premises; (e) PACE participant fails to complete and submit consents, releases, or assignments and other documents reasonably requested by the PACE provider in order to obtain or assure payment by Medicare, Medicaid, or other third party payers; or (f) PACE participant has died. (7) A PACE provider requesting disenrollment based on documentation under §E(6)(d) of this regulation shall report any illegal acts to law enforcement authorities or to the Medicaid Fraud Control Unit of the Department's Recipient Fraud Unit as appropriate. (8) If a request for disenrollment is approved, the PACE provider shall facilitate a PACE participant's enrollment into other programs by: (a) Making appropriate referrals; and (b) Ensuring clinical records are made available to new providers within 10 days of disenrollment. F. Disenrollment by the Department. The Department shall disenroll a PACE participant if the: (1) PACE Organization Provider Agreement between the PACE provider and the Department is terminated; (2) PACE participant dies; (3) PACE participant becomes ineligible for enrollment in accordance with Regulation .05 of this chapter; or (4) PACE participant loses eligibility for Medical Assistance Program benefits or changes to a category of assistance not eligible for enrollment in PACE. G. Effective Date of Termination. (1) The Department shall approve or disapprove requests for voluntary disenrollment within 5 working days of the date the request is received. (2) A disenrollment initiated by either the Department or the PACE provider because the participant died or became ineligible for enrollment for one of the other reasons specified in this regulation is effective the day after the event causing the ineligibility. (3) For disenrollments initiated by the Department, the Department shall provide the PACE provider with written notice. (4) A disenrollment resulting from the PACE participant's loss of Program eligibility shall be effective on the day following the PACE participant's last date of eligibility. (5) The Department may recover any capitation payments made on behalf of the PACE participant for periods following the effective date of the PACE participant's termination of enrollment or loss of eligibility, but not for a retroactive period greater than 3 months except in the case of: (a) The PACE participant's death; or (b) The PACE participant's relocation of domicile outside the PACE provider's service area. (6) The Department may determine a retroactive disenrollment date based on the conditions present when the disenrollment is requested or indicated. #### Regulation .08 PACE Participant Rights. *COMAR 10.09.44.08* The PACE provider shall ensure notification and protection of the rights of enrollees according to 42 CFR §460.110 and 42 CFR §460.112. #### Regulation .09 Covered Services. *COMAR 10.09.44.09* A. Except as limited or expanded by the PACE benefit package specified in the PACE program agreement, the PACE provider shall directly provide, arrange, purchase, or otherwise make available, as medically necessary and appropriate, the services specified in the State Plan and the PACE benefit package. B. The PACE benefit package for all PACE participants, regardless of the source of payment, shall include the following: (1) All Medicaid-covered services, as specified in the State Plan; (2) Multidisciplinary assessment and treatment planning; (3) Social work services; (4) Nutritional counseling; (5) Recreational therapy; (6) Certain meals; (7) Medical specialty services; (8) Prosthetics, orthotics, corrective vision devices, such as eyeglasses and lenses, hearing aids, dentures, and repair and maintenance of these items; (9) Assisted living; and (10) Other services determined necessary by the multidisciplinary team to improve and maintain the PACE participant's overall health status. C. For access, including access to emergency services, the PACE provider shall comply with 42 CFR §460.100. #### Regulation .10 Limitations on Coverage. *COMAR 10.09.44.10* Limitations on coverage are as specified in the PACE program agreement and 42 CFR §460.96. #### Regulation .11 Authorization Requirements. *COMAR 10.09.44.11* The PACE provider shall obtain approval by the Department before any changes in the following: A. Service contract agreements; B. PACE provider benefit package; C. PACE provider's service area; D. PACE provider's enrollment limit; E. PACE Organization Provider Agreement; or F. PACE provider structure. #### Regulation .12 Marketing and Information. *COMAR 10.09.44.12* A. The PACE Organization Provider Agreement shall specify the methods by which the PACE provider will assure the Department that its marketing plans, procedures, and materials are accurate and do not mislead, confuse, or defraud the Department or potential PACE participants. B. The PACE provider's marketing plan and all marketing procedures and materials require approval by the Department before implementation and utilization. C. The PACE provider may not participate in: (1) Activities described in 42 CFR §460.82(e); or (2) Face-to-face or telephone contact with a participant, or otherwise soliciting a participant who is not a PACE provider’s participant, unless authorized by the Department or initiated by the participant. D. Subject to prior approval by the Department, a PACE provider may engage in marketing activities designed to make [recipient] participants aware of the PACE provider's availability as well as any special services offered. Addressee-blind informational mailings to an entire zip code may be used. E. Enrollment Agreement and PACE Participant Enrollment Materials. (1) The PACE provider shall distribute the enrollment agreement within 14 days of the PACE participant's effective date of coverage with the PACE Program. (2) At a minimum the information in the enrollment agreement shall contain the following PACE participant enrollment materials which shall remain with the PACE participant: (a) Location or locations and office hours of the PACE providers; (b) Telephone number or numbers to call for more information; (c) Choice and use of primary care providers and policies on changing primary care providers; (d) How to access urgent care services and advice; (e) How and when to use emergency services including ambulance; (f) Information on the grievance and appeals process, including confidentiality and requesting an administrative hearing; (g) How to access interpreter services including sign interpreters; (h) PACE participant rights and responsibilities; (i) PACE participant's possible responsibility for charges including Medicare deductibles and coinsurances if the participant goes outside of the PACE Program for nonemergency care, or obtains noncovered services or services not authorized by the interdisciplinary team; (j) A clear statement that plan of care decisions are determined by the participant's interdisciplinary team; (k) Information on the availability of social services and assistance in placement in community-based housing and facilities; (l) Information on advance directives and physician order for life sustaining treatment; (m) How to obtain copies of the PACE participant's records; (n) How to obtain nonemergency ambulance services and other medical transportation to appointments, as appropriate; (o) Explanation of covered and noncovered services; (p) How to obtain prescriptions; and (q) Confidentiality policy. (3) The PACE provider shall review the enrollment agreement for accuracy at least yearly and update it with new or corrected information as needed to reflect the PACE provider's internal changes and regulatory changes. If changes impact the PACE participants' ability to use services or benefits, the PACE provider shall distribute the updated materials to all PACE participants after approval by the Department. (4) The provider shall offer orientation to the PACE program to new participants in person within 30 days of enrollment. #### Regulation .13 Quality Assurance and Improvement Systems. *COMAR 10.09.44.13* A. The PACE provider shall comply with 42 CFR Part 460, Subpart H (Quality Assessment and Performance Improvement). B. The PACE provider shall comply with requirements designated by the Department. #### Regulation .14 Record Keeping. *COMAR 10.09.44.14* The PACE provider shall comply with 42 CFR §460.210. #### Regulation .15 Reports and Data Collection. *COMAR 10.09.44.15* A. The PACE provider shall collect and submit to the Department service-specific encounter data by service type in the format and at the frequency designated by the Department and in conformance with the Department's computer coding requirements. B. Encounter data submitted by PACE providers under §A of this regulation shall include, at a minimum: (1) PACE participant and provider identifying information; (2) Service, procedure, and diagnosis codes; (3) Allowed, paid, and third-party liability amounts; and (4) Service, claims submission, adjudication, and payment dates. C. The PACE provider shall prepare and submit to the Department reports related to third-party liability as required by Regulation .20 of this chapter. D. The PACE provider shall immediately notify the Department if it has knowledge of a PACE participant's death. E. The PACE provider shall have an effective procedure for reporting to the Department the following information: (1) Patterns of utilization; (2) Health status of PACE participants; and (3) Appeals and grievances made by PACE participants. F. Quarterly Reports. A PACE provider shall submit to the Department quarterly, within 30 days of the close of each calendar quarter, and in a format designated by the Department: (1) Financial reports specified by the PACE program agreement; (2) Quality assurance reports including, but not limited, to quality assurance committee meeting minutes reflecting major quality assurance corrective action plans, initiatives, and activities; (3) Grievance reports, including emergency room based grievances, as specified in Regulation .19 of this chapter that contain (a) An analysis of PACE participant appeal and grievance records; (b) Identification of significant trends or anomalies; (c) The root causes of the trend or anomaly; and (d) Actions taken to address the trend or anomaly; (4) A list of all pre-service denials or reduction of services or benefits issued by the PACE provider or subcontractors during the preceding quarter; and (5) A report of the PACE provider’s participant advisory committee outlining the committee’s activities and recommendations. G. Annual Reports. The PACE provider shall submit to the Department annually, within 90 days after the end of the calendar year: (1) An annual summary of the information required by §E of this regulation; (2) Any revisions to the PACE provider's quality assurance or utilization management plans; (3) A copy of any changes in contractor agreements; (4) On-site proof that the PACE provider has obtained adequate insurance coverage, issued by an insurer authorized by the Maryland Insurance Administration to engage in the insurance business in the State, to protect its financial viability, and its ability to carry out its PACE program agreement obligations, including at a minimum: (a) Malpractice coverage for all professional and related employees of the PACE provider, as well as for the PACE provider itself; (b) Bonding of all employees and officers who have any responsibilities for the accounting and financial management activities of the PACE provider; and (c) Workers' compensation, fire, theft, casualty, and other coverage as required by State and local laws; (5) A proposed budget and financial plan for the PACE provider's operation, including: (a) An annualized cash flow chart; (b) The cost of operations; (c) Information demonstrating that the PACE provider has a fiscally sound operation; and (d) A statement of policy and procedures for accounting, capitation collection, methods of reimbursing providers and contractors, and method of payment for emergency and out-of-area claims; and (6) Financial monitoring reports, including any supplemental schedules required by the Department, prepared according to the criteria and reporting instructions and in the format and pursuant to the schedule required by the Department. H. For the purposes of Program administration or monitoring of the PACE provider's performance pursuant to this chapter, given a reasonable period of notice, the PACE provider shall supply other information the Department may request from time to time. #### Regulation .16 Confidentiality. *COMAR 10.09.44.16* A. Subject to the requirements of 42 CFR Part 431 Subpart F, the PACE provider and its contractors may not release or disclose any information concerning a PACE participant to anyone other than the Department except with the written permission of the: (1) PACE participant; or (2) PACE participant's attorney, legal representative, or legal guardian. B. For all information, records, data, and data elements collected and maintained by the PACE provider to facilitate operations under this chapter, the PACE provider shall: (1) Protect this information, records, data, and data elements from unauthorized disclosure, in accordance with the provisions of applicable federal and State laws and regulations; and (2) Assure that access is limited by the PACE provider to persons or agencies requiring the information to perform their duties in accordance with this chapter or other duties authorized by the Department. #### Regulation .17 Financial Solvency. *COMAR 10.09.44.17* The PACE provider shall comply with 42 CFR §460.80 and 42 CFR §460.208. #### Regulation .18 Subcontractual Relationships. *COMAR 10.09.44.18* A. Consistent with this chapter, the PACE provider, in performing its obligations under this chapter and the PACE program agreement, may either engage its own employees and agents or utilize the services of persons, firms, and other entities by means of contractual relationships. B. The PACE provider shall have a contractor agreement for all services which are not provided directly by the PACE provider through its own employees and agents. C. A contractor agreement may not diminish or alter the legal responsibility of the PACE provider to the Department to assure that all obligations under this chapter and the PACE program agreement are carried out. D. All service contractor agreements require preapproval by the Department. E. If there are proposed changes in a contractor agreement with any contractor, the full contractor agreement shall be submitted to the Department for prior approval. F. If the Department determines that termination or expiration of a PACE provider's contractual relationship materially affects the PACE provider's ability to carry out its responsibilities under the PACE [provider agreement] Organization Provider Agreement, the Department may terminate the PACE Organization Provider Agreement. G. The PACE provider may contract for any health care services not furnished directly by PACE in its benefit package to a health care provider that is licensed, certified, and meets Medicaid and Medicare participation requirements. H. Contractors shall be legally and professionally qualified to furnish the services set forth in the contractor agreement in return for the compensation set forth in the contractor agreement. #### Regulation .19 Internal Grievance Procedure. *COMAR 10.09.44.19* The PACE provider shall comply with the grievance procedures described at 42 CFR §460.120—124. #### Regulation .20 Third-Party Liability. *COMAR 10.09.44.20* A. The PACE provider shall identify and collect money owed from responsible third parties liable for the cost of health care services furnished by the PACE provider to its PACE participants. B. Upon request from the Department, the PACE provider shall convey any information regarding third-party liability to the Department and the U.S. Department of Health and Human Services. C. If both the Department and the PACE provider have a right of subrogation, the Department and the PACE provider shall coordinate settlement negotiation, ensuring that the funds available are prorated to allow sufficient compensation to settle each party's claim amount. D. For insurance coverage identified by the PACE provider with a retroactive effective date, the PACE provider shall ensure that procedures are in place for the collection of funds from either the provider or the insurance carrier for claims paid by the PACE provider during the coverage period, for up to 2 years from the date of health care services provided to the participant. #### Regulation .21 Payment Rates and Procedures. *COMAR 10.09.44.21* A. The Department shall: (1) Pay the PACE provider for each PACE participant based on the fixed capitation payment or payments specified in §E of this regulation; and (2) Calculate the capitation payment or payments for the PACE provider using the methodology described in §B of this regulation. B. Calculation of PACE Capitation Payments. (1) PACE capitation payments are calculated on a per-member per-month basis. (2) Capitation payments are specific to both the regional service area, as described in §C of this regulation, and the participant age and coverage status, as described in §D of this regulation. (3) Capitation payments are calculated using an AWOP analysis, which is determined using a base period of Medicaid fee for service participant data that: (a) Spans two State fiscal years; (b) Is specific to the PACE eligible population; (c) Is weighted by the expected ratio of participants receiving long-term care services in institutional and community-based settings; and (d) Excludes participants enrolled in the following programs: (i) Medicaid managed care programs; (ii) PACE; and (iii) Home and community-based services waivers operated by the Developmental Disabilities Administration. (4) The Department shall set the PACE capitation rate as 98 percent of the calculated AWOP. (5) The Department shall recalculate PACE capitation rates annually by trending forward the base period by 1 year. (6) Certain categories of costs not associated with a PACE-eligible, nursing facility-certified population are excluded from the claims data. C. Capitation rates shall be categorized by regional service area as follows: (1) Baltimore Metro — Baltimore City and Anne Arundel, Baltimore, Carroll, Cecil, Harford, and Howard counties; (2) Washington Metro — Calvert, Charles, Frederick, Montgomery, Prince George’s, and St. Mary’s counties; and (3) Rural Regions — Allegany, Caroline, Dorchester, Garrett, Kent, Queen Anne’s, Somerset, Talbot, Washington, Wicomico, and Worcester counties. D. Capitation rates shall be categorized by participant age and coverage status as follows: (1) Ages 55—64, Medicaid-only; (2) Ages 65 and over, Medicaid-only; (3) Ages 55—64, dual eligibility; and (4) Ages 65 and over, dual eligibility. E. For services provided on or after January 1, 2024, the Department shall pay the PACE provider at the following per-member per-month capitation rates: F. The capitation rate paid by the Department to the PACE provider for a participant shall be accepted as payment in full for the PACE provider benefit package provided by the PACE provider according to its PACE Organization Provider Agreement, and additional charge may not be made to the participant, the Department, or any other entity except as provided under Regulation .05 of this chapter. G. The Department shall recover any overpayments made to the PACE provider. H. A capitation payment may not be made to the PACE provider on behalf of a participant for whom fee-for-service or a capitation payment for the same period has been made by the Department to any other provider, HMO, or managed care organization. I. Capitation payment may not be made to the PACE provider on behalf of a participant if the Department's eligibility verification system indicates that the participant is not eligible for Medicaid benefits. J. The Department shall provide retroactive capitation to the PACE provider on behalf of a participant when: (1) The Department's eligibility verification system indicates that the participant has established a retroactive eligibility period to a previous PACE enrollment period; and (2) Services were provided by the PACE provider and no other fee-for-service provider. K. Program Changes. (1) Amendments, revisions, or additions to the State Plan or the State or federal regulations, guidelines, or policies shall, insofar as they affect the scope or nature of Program benefits available to eligible persons, be considered as amendments to the PACE provider benefit package, unless the Department shall otherwise notify the PACE provider. (2) The Department or PACE may determine that a change in the PACE provider benefit package, or in the Program's reporting or other administrative requirements, is a substantial modification of the financial or other responsibilities of the PACE provider, and so may request an adjustment in the PACE provider's capitation payment. (3) Refusal of an adjustment in the PACE provider's capitation payment by the other party shall, at the discretion of the party making the request, be grounds for termination of the PACE Organization Provider Agreement. #### Regulation .22 Payment for Emergency Services. *COMAR 10.09.44.22* A. The PACE provider shall be responsible for prompt payment for all emergency services received by PACE participants. B. If a claim is submitted to the PACE provider within 9 months of the date of service, the PACE provider shall reimburse a hospital emergency facility and provider or free-standing urgent care center, without requiring prior authorization or approval for payment from the PACE provider, for: (1) Emergency services; (2) Medical screening services rendered at an emergency facility to meet the requirements of the federal Emergency Medical Treatment and Active Labor Act; and (3) Medically necessary and appropriate services if: (a) The PACE provider authorized, referred, or otherwise allowed the PACE participant to use the emergency facility; and (b) The services are related to the condition for which the PACE participant was allowed to use the emergency facility. #### Regulation .23 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.44.23* A. Cause for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. B. If the Department determines that a provider, any agent or employee of the provider, or any person with an ownership interest in the provider or related party of the provider has failed to comply with applicable federal or State laws or regulations, the Department may: (1) Impose one or more of the actions under COMAR 10.09.36.08A; and (2) Suspend the PACE provider’s ability to enroll new PACE participants. #### Regulation .24 Appeal Procedures. *COMAR 10.09.44.24* A. The PACE provider shall comply with 42 CFR §460.122. B. PACE provider appeal procedures under this chapter are set forth in COMAR 10.09.36.09. C. PACE participant appeals are set forth in COMAR 10.01.04. #### Regulation .25 Interpretive Regulation. *COMAR 10.09.44.25* Interpretation of this regulation is subject to COMAR 10.09.36. ### Chapter 45 — Mental Health Case Management: Care Coordination for Adults **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: January 20, 1992 (19:1 Md. R. 32) **Administrative History:** Regulations .01—.06 amended as an emergency provision effective July 1, 1992 (19:15 Md. R. 1383); amended permanently effective October 26, 1992 (19:21 Md. R. 1891) **Administrative History:** Regulations .01B and .02B amended as an emergency provision effective June 1, 1993 (20:12 Md. R. 995); adopted permanently effective September 1, 1993 (20:17 Md. R. 1346) **Administrative History:** Regulations .01 and .02 amended as an emergency provision effective February 8, 1995 (22:5 Md. R. 365); emergency status expired May 31, 1995; amended permanently effective June 5, 1995 (22:11 Md. R. 821) **Administrative History:** Regulations .01—.06 amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1288); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .04A, C amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .05-1 adopted as an emergency provision effective July 1, 1997 (24:18 Md. R. 1288); amended permanently effective December 29, 1997 (24:26 Md. R. 1758) **Administrative History:** Regulations .01—.10 repealed and new Regulations .01—.13 adopted as an emergency provision effective August 21, 2009 (36:19 Md. R. 1433); adopted permanently effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .01A amended effective October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .02B amended effective October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .03A amended effective October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .03E adopted effective October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .04C, E amended effective October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .06 amended effective October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .07C amended effective October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .09E adopted effective October 1, 2014 (41:19 Md. R. 1077) #### Regulation .01 Scope. *COMAR 10.09.45.01* A. This chapter applies to providers organized to deliver mental health case management services to adults. B. The purpose of mental health case management is to assist participants in gaining access to needed medical, mental health, social, educational, and other services. #### Regulation .02 Definitions. *COMAR 10.09.45.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative services organization (ASO)” means the entity with which the Mental Hygiene Administration may contract to provide the services described in COMAR 10.09.70 for the public mental health system. (2) “Adult” means an individual 18 years and older. (3) “Care plan” means the plan prepared according to the requirements outlined in this chapter that delineate the plan of care for a specific participant. (4) “Case manager” means a community support specialist. (5) “Community support specialist” means an individual who is employed by a mental health case management provider to deliver case management services to participants. (6) “Community support specialist associate” means an individual who is employed by a mental health case management provider to assist community support specialists in the provision of mental health case management services to participants. (7) “Community support specialist supervisor” means an individual who is employed or under contract to supervise case management services. (8) “Core service agency (CSA)” has the meaning stated in COMAR 10.21.17. (9) “Department” has the meaning stated in COMAR 10.09.36.01. (10) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (11) “Mental health case management provider” means a provider that: (a) Is approved under this chapter to provide mental health case management services to adults 18 years or older; and (b) Utilizes a collaborative process of assessment, planning, implementation, coordination, monitoring, and evaluation of the options and services required to meet an individual's health needs through communication and available resources to promote quality cost-effective outcomes. (12) “Mental health case management services” means services covered under this chapter which assist participants in gaining access to the full range of mental health services, as well as to any additional needed medical, social, financial assistance, counseling, educational, housing, and other support services. (13) “Mental health professional” has the meaning stated in COMAR 10.21.17. (14) “Mental health services” means those services described in COMAR 10.09.70.10C rendered to treat an individual for a diagnosis set forth in COMAR 10.09.70.10A. (15) “Mental Hygiene Administration (MHA)” means the Department's administration that is charged with the responsibility for providing services to mentally ill individuals, as defined in Health-General Article, Title 10, Annotated Code of Maryland. (16) “Nonparticipant” means an individual who does not meet the qualifications for participation in mental health case management that are specified in Regulation .03 of this chapter. (17) “Participant” means an individual who meets the qualifications for participation in mental health case management that are specified in Regulation .03 of this chapter. (18) “Program” has the meaning stated in COMAR 10.09.36.01. (19) “Provider” means the mental health case management services provider. (20) “Recipient” has the meaning stated in COMAR 10.09.36.01. (21) “Serious and persistent mental disorder” means a disorder that is: (a) Manifested in an individual 18 years old or older; and (b) Diagnosed, according to a current diagnostic and statistical manual of the American Psychiatric Association that is recognized by the Secretary as: (i) Schizophrenic disorder; (ii) Major affective disorder; (iii) Other psychotic disorder; or (iv) Borderline or schizotypal personality disorders, with the exclusion of an abnormality that is manifested only by repeated criminal or otherwise antisocial conduct. (22) “Unit of service” means a per day rate for a minimum of 1 hour per day for contacts, including face-to-face contacts with a participant, and non-face-to-face contacts on behalf of the participant with nonparticipants, that are directly related to identifying the needs and supports for helping the individual to access services. #### Regulation .03 Participant Eligibility. *COMAR 10.09.45.03* A. A recipient is eligible for mental health case management services if the recipient: (1) Is in a federal eligibility category for Maryland Medical Assistance according to COMAR 10.09.24, which governs the determination of eligibility for the Maryland Medical Assistance Program; and (2) Has a serious and persistent mental health disorder and is: (a) In, at risk of, or needs continued community treatment to prevent, inpatient psychiatric treatment; (b) At risk of, or needs continued community treatment to prevent, being homeless; or (c) At risk of incarceration or who will be released from a detention center or prison. B. Waiver of Specific Diagnostic Criteria. The specific diagnostic criteria may be waived if an individual is: (1) Committed as not criminally responsible and is conditionally released from a Mental Hygiene Administration (MHA) facility, according to the provisions of Health-General Article, Title 12, Annotated Code of Maryland; or (2) In a MHA facility, or is a MHA-funded individual in a psychiatric inpatient hospital who requires community services, excluding individuals who are eligible for Developmental Disabilities Administration's residential services. C. Eligible individuals transitioning from institutions as described in either §B(1) or (2) of this regulation to a community-based setting may receive case management services for up to 180 consecutive days of the covered stay in the institution. D. Levels of Care. (1) In addition to meeting the eligibility criteria outlined under §§A and B of this regulation, participants shall be classified according to the levels of care listed in §D(2) or (3) of this regulation. (2) Level I—General. For a maximum of 2 units of service per month and based on the severity of the participant's mental illness, the participant shall meet at least one of the following conditions: (a) The participant is not linked to mental health and medical services; (b) The participant lacks basic supports for shelter, food, and income; (c) The participant is transitioning from one level of care to another level of care; or (d) The participant needs case management services to maintain community-based treatment and services. (3) Level II—Intensive. For a maximum of 5 units of service per month and based on the severity of the participant's mental illness, the participant shall meet two or more of the following conditions: (a) The participant is not linked to mental health and medical services; (b) The participant lacks basic supports for shelter, food, and income; (c) The participant is transitioning from one level of care to another level of care; or (d) The participant needs case management services to maintain community-based treatment and services. E. A participant may not be enrolled in Mental Health Case Management for Adults while receiving services under COMAR 10.09.90 or 10.09.33. #### Regulation .04 Conditions for Mental Health Case Management Provider Participation. *COMAR 10.09.45.04* A. The local core service agencies shall select mental health case management providers through a competitive procurement process, at least once every 5 years. B. Mental health case management services may be provided by local health departments according to COMAR 10.04.04, which allows the Director of the MHA to utilize the local health departments as vendors unless the health officer believes the service provided by alternate vendors would be preferable. C. Providers of mental health case management shall: (1) Be approved or licensed in Maryland as a community mental health provider under COMAR 10.21.19, 10.21.20, 10.21.21, or 10.21.29, or have 3 years experience as a mental health case management provider; and (2) Have at least 3 years experience providing mental health services, including serving high risk populations, to adults with serious mental illness. D. General Requirements. To be eligible to be approved as a mental health case management service provider, an entity shall meet all of the: (1) Conditions for participation as set forth in COMAR 10.09.36.03; and (2) Medical Assistance provisions listed in COMAR designated for their provider type. E. Specific Requirements. A mental health case management service provider: (1) May not place restrictions on the qualified recipient's right to elect to or decline to: (a) Receive mental health case management as authorized by the Department or the Department's designee; and (b) Choose a community support specialist or associate, as approved by the Department or the Department's designee, and other medical care providers; (2) Shall employ appropriately qualified individuals as community support specialists, community support specialist associates, and community support specialist supervisors with relevant work experience, including experience with the target population, including but not limited to adults with a serious and persistent mental disorder; (3) Shall assure that: (a) A participant's initial assessment is completed within 20 days after the participant has been authorized by the ASO and determined eligible for, and has elected to receive, mental health case management services; and (b) An initial care plan is completed within 10 days after completion of the initial assessment; (4) Shall maintain a file for each participant which includes all of the following: (a) An initial referral and intake form with identifying information, including, but not limited to, the individual's name and Medicaid identification number; (b) A written agreement for services signed by the participant or the participant's legally authorized representative and by the participant's community support specialist; (c) An assessment as specified in Regulation .06 of this chapter; (d) A care plan, updated at a minimum of every 6 months, which contains at a minimum: (i) A description of the participant's strengths and needs; (ii) The diagnosis established as evidence of the participant's eligibility for services under this chapter; (iii) The goals of case management services, with expected target dates; (iv) The proposed intervention; (v) Designation of the community support specialist with primary responsibility for implementation of the care plan; and (vi) Signatures of the community support specialist, participant, or the participant's legally authorized representative, and significant others, if appropriate; (e) An ongoing record of contacts made on the participant's behalf, which includes all of the following: (i) Date and subject of contact; (ii) Individual contacted; (iii) Signature of community support specialist or community support specialist associate making the contact; (iv) Nature, content, and unit or units of service provided; (v) Place of service; (vi) Whether goals specified in the care plan have been achieved; (vii) The timeline for obtaining needed services; (viii) The timeline for reevaluation of the plan; and (ix) The need for and occurrences of coordination with other case managers; and (f) Monthly summary notes, which reflect progress made towards the participant's stated goals; (5) Shall have formal written policies and procedures, approved by the Department, or the Department's designee, which specifically address the provision of mental health case management services to participants in accordance with the requirements of this chapter; (6) Shall be available to participants and, as appropriate, their families for 24 hours a day, 7 days a week in order to refer: (a) Participants to needed services and supports; and (b) In a psychiatric emergency, participants to mental health treatment and evaluation services in order to prevent the participant from accessing a higher level of care; (7) Shall document in the participant's case management records if the participant declines case management services; (8) May not provide other services to participants which would be viewed by the Department as a conflict of interest; (9) Shall be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants; (10) Shall maintain information on current resources for mental health, medical, social, financial assistance, vocational, educational, housing, and other support services; (11) Shall safeguard the confidentiality of the participant's records in accordance with State and federal laws and regulations governing confidentiality; (12) Shall comply with the Department's fiscal reporting requirements and submit reports in the manner specified by the Department; (13) Shall provide services in a manner consistent with the best interest of recipients and may not restrict an individual's access to other services; and (14) Shall assure the amount, duration, and scope of the case management activities are documented in a participant's care plan, which includes mental health case management activities before discharge and after discharge when transitioning from an institution, to facilitate a successful transition into the community. #### Regulation .05 Mental Health Case Management Provider Staff. *COMAR 10.09.45.05* Required Staff. The mental health case management provider shall have staff that is sufficient in numbers and qualifications to provide appropriate services to the participants served and shall include, at a minimum: A. A community support specialist supervisor who: (1) Is a mental health professional who is licensed and legally authorized to practice under the Health Occupations Article, Annotated Code of Maryland, and who is licensed under Maryland Practice Boards in the profession of: (a) Social work; (b) Professional Counseling; (c) Psychology; (d) Nursing; (e) Occupational Therapy; or (f) Medicine; (2) Has 1 year of experience in mental health working as a supervisor; (3) Provides clinical consultation and training to community support specialists or associates regarding mental illness; and (4) Is employed or contracted to supervise case management services at a ratio of one supervisor to every eight community support specialists or associates; B. A community support specialist who: (1) Has at least a: (a) Bachelor's degree in a mental health field and 1 year of mental health experience, including mental health peer support; or (b) Bachelor's degree in a field other than mental health and 2 years of mental health experience, including mental health peer support; (2) Is chosen as the case manager by the participant or the participant's legally authorized representative; and (3) Is employed by the mental health case management provider to provide case management services to participants; and C. A community support specialist associate who: (1) Has at least a high school degree or the equivalent, and 2 years of experience with individuals with mental illness, including mental health peer support; (2) Is employed by the mental health case management provider to assist community support specialists in the provision of mental health case management services to participants; and (3) Works under the supervision of a community support specialist who delegates specific tasks to the associate. #### Regulation .06 Covered Services. *COMAR 10.09.45.06* A. The Department shall reimburse for the services in §§C—I of this regulation under mental health case management when these services have been documented, pursuant to the requirements in this chapter, as necessary. B. Case management services shall be coordinated with, and may not duplicate activities provided as part of, institutional services and discharge planning activities. C. Comprehensive Assessment and Periodic Reassessment. (1) Assessment or reassessment involves the participant's stated needs and review of information concerning the participant's mental health, social, familial, cultural, medical, developmental, legal, vocational, and economic status to assist in the formulation of a care plan. (2) The assessment or reassessment of the participant’s stated needs and service needs is conducted by the community support specialist and incorporates input from the participant, family members, and friends of the participant, as appropriate, and community service providers, such as mental health providers, medical providers, social workers, and educators, if necessary. (3) A home visit, or visit at another location suitable to the participant's needs, by the community support specialist or community support specialist associate is required every 90 days. (4) After an initial assessment, each participant shall be reassessed every 6 months. D. Development and Periodic Revision of a Specific Care Plan. (1) After the initial assessment is completed, a care plan shall be developed. (2) After the care plan is developed, it shall be updated every 6 months in conjunction with the participant's schedule for reassessments, to ensure that all services being provided remain sufficient. (3) The participant, a legal guardian, the participant’s family or any significant others with the participant’s consent, shall participate with the community support specialist, to the extent practicable, in the development and regular updating of the participant’s care plan. (4) The specific care plan shall: (a) Be developed with the participant and based on the assessment; (b) Specify the goals and actions to address the mental health, medical, social, educational, and other services needed by the participant; (c) Include the active participation and agreement of the participant, the participant’s authorized health care decision maker, if applicable, and others designated by the participant; and (d) Identify strategies to meet the goals and needs of the participant. (5) The care planning process may include, as necessary and appropriate: (a) The care planning meeting, which includes the participant, and with the participant's consent, providers, family members, other interested persons, as appropriate, for the purpose of establishing, revising, and reviewing the care plan; (b) The development and periodic updating of the written, individualized care plan based on the participant's needs, progress, and stated goals; (c) Transitional care planning that involves contact with the participant or the staff of a referring agency, or a service provider who is responsible to plan for continuity of care from inpatient level of care or an out-of-home placement to another type of community service; and (d) Discharge planning from mental health case management services, when appropriate and when goals for mental health case management have been achieved. E. Referral and Related Activities. (1) The community support specialist or associate, under the direction of a community support specialist, shall assure that the participant has applied for, has access to, and is receiving the necessary services available to meet the participant’s needs, such as mental health services, resource procurement, transportation, or crisis intervention. (2) The community support specialist shall take the necessary action when the services identified under §D of this regulation have not occurred. (3) The linkage process shall include: (a) Community support development by contacting, with the participant’s consent, members of the participant’s support network, for example, family, friends, and neighbors, as appropriate, to mobilize assistance for the participant; (b) Crisis intervention by referral of the participant, to services on an emergency basis when immediate intervention is necessary; (c) Arranging for the participant's transportation to and from services; (d) Outreach in an attempt to locate service providers which can meet the participant’s needs; and (e) Reviewing the care plan with the participant and with the participant’s family and friends, as appropriate, so as to enable and facilitate their participation in the plan’s implementation. F. Monitoring and Follow-Up Activities. (1) A mental health case management provider shall monitor, as frequently as necessary, the activities and contacts that are considered necessary to ensure the care plan is implemented and adequately addresses the participant’s needs, and include: (a) The participant; and (b) With proper consent: (i) Family members and friends, if appropriate; and (ii) Other service providers, if any. (2) In addition to the requirements outlined in §E of this regulation, the case management provider shall conduct, every 6 months, a reassessment to determine whether: (a) Services are being furnished in accordance with the participant's care plan; (b) Services in the care plan are adequate; and (c) If the needs of the participant change, and if applicable, necessary adjustments are made to the care plan, including referrals for services. (3) The mental health case management provider shall: (a) Follow up any service referral to determine whether the participant made contact with the service provider that the participant was referred to; and (b) Monitor service provision on an ongoing basis, to ensure that the agreed-upon services are provided, are adequate in quantity and quality, and meet the participant’s needs and stated goals. (4) The mental health case management provider may revise the care plan to reflect changing needs identified from the service monitoring. G. Mental health case management may include contacts with non-participants that are directly related to identifying the needs and supports for helping the participant to access services. H. The mental health case management provider shall engage in participant advocacy, including: (1) Empowering the participant to secure needed services; (2) Taking any necessary actions to secure services on the participant's behalf; and (3) Encouraging and facilitating the participant’s decision making and choices leading to accomplishment of the participant’s goals. I. Service Provision. Mental health case management services shall be provided in accordance with the following: (1) For participants in Level I—General, a mental health case management provider shall provide a minimum of 1 and a maximum of 2 days of service each month; (2) For participants in Level II—Intensive, a mental health case management provider shall provide a minimum of 2 and a maximum of 5 days of service each month; and (3) One additional unit of service above the monthly maximum may be billed during the first month of service to a participant in order to complete the comprehensive assessment. #### Regulation .07 Limitations. *COMAR 10.09.45.07* A. Mental health case management services are advisory in nature. B. A restriction may not be placed on a qualified recipient's option to receive mental health case management services. C. Mental health case management services do not restrict or otherwise affect: (1) Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation; (2) The freedom of a participant to select from all available services for which the participant is found to be eligible; or (3) A participant’s free choice among qualified providers. D. Mental health case management providers may not bill the Program for: (1) The direct delivery of an underlying medical, educational, social, or other service to which a participant has been referred; (2) Activities integral to the administration of foster care programs; (3) Activities not consistent with the definition of case management services under Section 6052 of the federal Deficit Reduction Act of 2005 (P.L. 109-171); (4) Activities for which third parties are liable to pay; or (5) Activities delivered as part of institutional discharge planning. E. Reimbursement may not be made for mental health case management services if the participant is receiving a comparable case management service under another Program authority. F. A participant's case manager may not be the participant's family member or a direct service provider for the participant. #### Regulation .08 Preauthorization. *COMAR 10.09.45.08* All covered services under this chapter shall be preauthorized and comply with the requirements of COMAR 10.09.70.07. #### Regulation .09 Payment Procedures. *COMAR 10.09.45.09* A. The Program shall reimburse the provider according to the requirements in this chapter and the fees established under COMAR 10.21.25. B. Request for Payment. (1) Requests for payment of mental health case management services shall be submitted by an approved provider according to procedures established by the Department. The Department reserves the right to return to the provider, before payment, all invoices not properly signed and completed. (2) A provider shall submit a request for payment on the invoice form designated by the Department. A separate invoice shall be submitted for each participant. The completed form shall indicate the: (a) Date or dates of service; (b) Participant's name and Medical Assistance number; (c) Provider's name, location, and provider number; and (d) Nature, unit or units, and procedure code or codes of covered services provided. (3) A provider shall bill the Program for the appropriate fee or fees specified in COMAR 10.21.25. (4) The Program may not make direct payment to recipients. C. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. D. Payment shall be made: (1) Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; and (2) According to the requirements of this chapter and the fees established in COMAR 10.21.25. E. The Department may reimburse providers for service delivery beyond the maximum units stated in COMAR 10.21.25 only if pre-authorized by the ASO based on a review of medical necessity. #### Regulation .10 Recovery and Reimbursement. *COMAR 10.09.45.10* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .11 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.45.11* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .12 Appeal Procedures. *COMAR 10.09.45.12* Appeal procedures are those set forth in COMAR 10.09.36.09. #### Regulation .13 Interpretive Regulation. *COMAR 10.09.45.13* State regulations are interpreted as those set forth in COMAR 10.09.36.10. ### Chapter 46 — Home and Community-Based Services Waiver for Individuals with Brain Injury **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.16 adopted as an emergency provision effective July 1, 2003 (30:14 Md. R. 933); adopted permanently effective December 11, 2003 (30:24 Md. R. 1740) **Administrative History:** Regulation .01B amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .01B amended effective January 6, 2014 (40:26 Md. R. 2163); May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .02B amended effective January 25, 2010 (37:2 Md. R. 67) **Administrative History:** Regulation .02C, D amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .03 amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .03B, E amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .03B, F amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .03F amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 516); May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .04A amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .04B amended effective April 9, 2007 (34:7 Md. R. 698); May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .04C amended effective May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .05 amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .05 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .05 amended effective January 6, 2014 (40:26 Md. R. 2163); May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .06 amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .06E adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); adopted permanently effective October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .07C amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .07D amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .08E amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .08F amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .09C amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .09-1 adopted effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .09-1 amended effective May 18, 2020 (47:10 Md. R. 516); May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .09-1C amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .09-2 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); adopted permanently effective October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .10B amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .11C amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .11C, D amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .12A amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .12A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) **Administrative History:** Regulation .12C amended effective May 1, 2023 (50:8 Md. R. 338); March 3, 2025 (52:4 Md. R. 218); June 8, 2026 (53:11 Md. R. 485) **Administrative History:** Regulation .13 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1481); amended permanently effective October 6, 2008 (35:20 Md. R. 1774) #### Regulation .01 Definitions. *COMAR 10.09.46.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual who is applying as a participant in the BI waiver. (2) “Behavior intervention” means services designed to assist individuals who exhibit challenging behaviors in acquiring skills, gaining social acceptance, and becoming full participants in the community, consistent with behavior support services program service plans set forth in COMAR 10.22.10. (3) “Behavioral Health Administration (BHA)” means the administration of the Department that: (a) Is charged with the responsibility for providing services to individuals with behavioral health conditions as defined by Health-General Article, Title 10, Annotated Code of Maryland; (b) Is designated as the State’s lead agency for service delivery to individuals with brain injury; and (c) Manages the BI waiver, in collaboration with the Program and in accordance with a memorandum of agreement signed with the Program. (4) “Brain injury (BI)” means an insult to the brain caused by an external or internal mechanism that occurs after birth and is not related to congenital or degenerative disease, which results in cognitive, physical, behavioral, or emotional disability that is documented in the medical record. (5) “CARF” means the Commission on Accreditation of Rehabilitation Facilities, a nonprofit accrediting body which promotes quality, value, and optimal outcomes of services through a consultative accreditation process that centers on enhancing the lives of individuals receiving services. (6) Case Management. (a) “Case management” means the services provided by a case manager who assists an individual in gaining access to needed medical, social, educational, and other services. (b) “Case management” includes assessment, referral, coordination, and monitoring of the plan of care. (7) “Case manager” means an individual who provides administrative case management services for BI waiver participants. (8) “Day habilitation” means assistance with acquisition, retention, or improvement in self-help, socialization, and adaptive skills which takes place in a nonresidential setting, separate from the home or facility in which the individual resides, normally furnished 4 or more hours per day. (9) “Department” means the Maryland Department of Health as stated in COMAR 10.09.36.01B, or its authorized agents acting on behalf of the Department. (10) “Eligible individual” means an individual who is determined to meet the qualifications for participation in the BI waiver as specified in Regulation .03 of this chapter. (11) “Health care professional” means an individual who is licensed and authorized by the Health Occupations Article to provide the health service for which the individual is privileged. (12) Home and community-based services waiver for individuals with brain injury (BI waiver) means the program implemented under this chapter. (13) “Individual support services (ISS)” means assistance with acquisition, retention, or improvement in skills related to self-help, socialization, and/or adaptive skills furnished in the participant's home or community by a provider who does not have round-the-clock responsibility for the participant's health and welfare. (14) “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped individuals who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living in accordance with COMAR 10.09.07. (15) “Nursing facility level of care” means an assessment that an individual needs the level of services provided in a nursing facility, as defined in COMAR 10.09.10.01. (16) “Participant” means an eligible individual who is enrolled in the BI Waiver. (17) “Program” means the Medical Assistance Program, as stated in COMAR 10.09.36.01B, which exercises administrative discretion in the administration and supervision of the BI waiver and issues policies, rules, and regulations related to the BI waiver. (18) “Provider” means an individual or an agency that: (a) Is approved by the BHA and the Program as meeting the conditions for waiver participation specified in Regulations .05 and .06 of this chapter; and (b) Has enrolled with the Program to provide one or more of the waiver services described under Regulations .07—.09 of this chapter. (19) “Provider agreement” means a contract between the Program and a provider to provide services to waiver participants. (20) “Residential habilitation” means assistance with acquisition, retention, or improvement in skills related to activities of daily living and the social and adaptive skills necessary to enable the individual to live in a noninstitutional setting. (21) “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in or associated with an individual's place of residence. (22) “State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of Title XIX of the Social Security Act and approved by the federal Centers for Medicare and Medicaid Services, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements. (23) “Supported employment” means activities needed to support paid work by individuals receiving waiver services, including supervision and training. (24) “Utilization control agent” means the organization responsible for reviewing services to determine medical necessity according to professional standards and for conducting patient assessments. (25) “Virtual supports” is an electronic method of service delivery used to maintain or improve a participant’s functional abilities, enhance interactions, support meaningful relationships, and promote their ability to live independently and meaningfully participate in their community. (26) “Waiver plan of care” means a participant's written, individualized care plan as specified in Regulation .04 of this chapter. #### Regulation .02 Medical Assistance Eligibility. *COMAR 10.09.46.02* A. Financial eligibility for waiver participants is determined according to the provisions of this regulation and applicable sections of COMAR 10.09.24 Medical Assistance Eligibility, as cited in this section. B. Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as: (1) A recipient of Supplemental Security Income (SSI); (2) A member of a low income family with children, as described in §1931 of the Social Security Act; or (3) A recipient eligible in another mandatory or optional categorically needy coverage group with full Medical Assistance benefits, covered in the community under the State Plan. C. Optionally Categorically Needy. (1) An individual is eligible for waiver services as optionally categorically needy in accordance with 42 CFR §435.217, if the individual's countable income does not exceed 300 percent of the applicable payment rate for SSI, and the individual's countable resources do not exceed the SSI resource standard for one person. (2) For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one person. (3) For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income rules set forth in COMAR 10.09.24, which are applicable to an aged, blind, or disabled individual who is institutionalized, with the exceptions specified in §C(9) of this regulation. (4) For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource rules set forth in COMAR 10.09.24, which are applicable to an aged, blind, or disabled person who is institutionalized, with the exceptions specified in §C(9) of this regulation. (5) An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until the penalty time expires. (6) The spousal impoverishment rules at COMAR 10.09.24.10-1 are applicable, except for the following differences in definitions: (a) “Community spouse” means an individual who: (i) Lives in the community outside a medical institution; (ii) Is not determined to meet the criteria for participation in the Waiver for Individuals with Brain Injury or any other waiver under §1915(c) of Title XIX of the Social Security Act; and (iii) Is married to an institutionalized spouse. (b) “Continuous period of institutionalization” means: (i) At least 30 consecutive days of institutional care in a nursing facility or other medical institution; or (ii) A determination that a spouse meets the criteria for participation in the waiver for individuals with brain injury or any other waiver under §1915(c) of Title XIX of the Social Security Act. (c) “Institutionalized spouse” means an individual who is married to a community spouse and who is: (i) An inpatient in a nursing facility or other medical institution with a length of stay exceeding 30 days; or (ii) Determined to meet the criteria for participation in the waiver for individuals with brain injury or any other waiver under §1915(c) of the Social Security Act. (7) Medical Assistance eligibility shall be redetermined at least every 12 months. (8) As part of the determination and redetermination of Medical Assistance eligibility as optionally categorically needy, the Department of Human Services shall determine whether the applicant or recipient is eligible as a disabled person in accordance with COMAR 10.09.24.05E, unless the applicant or recipient is aged, blind, or has been determined as disabled by the Social Security Administration. (9) All provisions of COMAR 10.09.24 which are applicable to an aged, blind, or disabled individual who is institutionalized are applicable to waiver applicants and participants who are considered as optionally categorically needy, with the following exceptions in full or in part: (a) COMAR 10.09.24.04J(1)—(3); (b) COMAR 10.09.24.04K; (c) COMAR 10.09.24.06B(2)(a)(ii); (d) COMAR 10.09.24.08G(1); (e) COMAR 10.09.24.08H; (f) COMAR 10.09.24.09; (g) COMAR 10.09.24.10; (h) COMAR 10.09.24.10-1; and (i) COMAR 10.09.24.15A-2(2). (10) Home Exclusion. The home, as defined in COMAR 10.09.24.08B, is not a countable resource under §C of this regulation if it is occupied by the waiver applicant or participant, the applicant's or participant's spouse, or any one of the following relatives who are medically or financially dependent on the applicant or participant: (a) Child; (b) Parent; or (c) Sibling. D. Posteligibility Determination of Available Income for Optionally Categorically Needy. Participants in the waiver for individuals with brain injury are not required to pay towards their cost of care, and therefore they are not subject to a posteligibility determination of available income. E. Medically Needy. An individual is not eligible for waiver services if the individual is receiving Medical Assistance as a medically needy person in accordance with COMAR 10.09.24.03D. #### Regulation .03 Participant Eligibility. *COMAR 10.09.46.03* A. Medical Eligibility for the Waiver. (1) To be medically eligible for the services covered under this chapter, an applicant shall be certified by the Program's utilization control agent to need nursing facility level of care or special hospital level of care. (2) Every 12 months, or more frequently if determined necessary by the BHA or Program due to a significant change in the participant's condition or need, a participant's medical need for nursing facility level of care or special hospital level of care shall be reevaluated by the Program's utilization control agent. B. Technical Eligibility for the Waiver. An applicant or participant shall be determined by the BHA, using the form for determination of eligibility for BI waiver services, to meet the waiver's technical eligibility criteria if the individual: (1) Is 22 years old or older but younger than 65 years old at the time of initial admission to the waiver; (2) Is diagnosed with brain injury as defined in Regulation .01B(4) of this chapter by a qualified physician; (3) Was 18 years old or older when the brain injury was sustained; (4) Is receiving: (a) Care in a State psychiatric hospital that is determined to be inappropriate because the individual does not need that level of care; (b) Brain injury community placement funded by the BHA with all-State funds; (c) Care in a nursing facility owned and operated by the State or an out-of-State rehabilitation institution funded by the Program; or (d) Care in a Maryland licensed special hospital for chronic disease accredited by CARF in brain injury inpatient rehabilitation; (5) Is not enrolled in another waiver program under §1915(c) of Title XIX of the Social Security Act; (6) Is clinically appropriate to be served in the waiver program and the waiver plan of care can serve the individual safely in the community; (7) Chooses directly, or a legal representative chooses on the individual's behalf, to receive waiver services as an alternative to services in a nursing facility or special hospital, and documents that choice on the consent form for BI waiver services included in the approved waiver proposal; (8) Costs the Program no more in the community than what the individual would have cost the Program in the alternative institutional placement at the nursing facility level of care or special hospital level of care, as demonstrated on the waiver plan of care and by the Program's paid claims; and (9) Uses at least one waiver service in a 12 month period. C. Financial Eligibility for Medicaid. Waiver participants shall qualify for one of the categories of assistance set forth in Regulation .02 of this chapter. D. During a 12-month waiver year, as defined in the approved waiver proposal, eligible individuals shall be enrolled in the waiver up to the maximum number of unduplicated participants established for that waiver year in the approved waiver proposal. E. Overall Waiver Eligibility. (1) Using the form for determination of eligibility for BI waiver services, if an applicant is determined by the BHA: (a) To meet all of the criteria specified in §§A—C of this regulation, the BHA or its authorized representatives shall sign and date the form to certify waiver eligibility and establish the effective date for waiver enrollment; or (b) Not to meet all of the criteria specified in §§A—C of this regulation: (i) The BHA or its authorized representatives shall sign and date the form to certify waiver ineligibility determination and specify in writing the reason or reasons for the determination; and (ii) The applicant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E. (2) Every 12 months, or more often if there is a significant change in the participant's condition or needs: (a) The BHA and the Program's utilization control agent shall reevaluate whether the participant remains eligible for the waiver by meeting all of the criteria specified in §§A—C of this regulation; (b) The BHA or its authorized representatives shall sign and date the form for determination of eligibility for BI waiver services to certify the redetermination of waiver eligibility; and (c) If the BHA determines that the participant no longer meets all of the eligibility criteria specified in §§A—C of this regulation, the: (i) Participant's eligibility shall be terminated, as of the effective date established by the BHA; and (ii) The participant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E. F. Cause for Termination of a Participant's Waiver Enrollment. (1) A participant shall be disenrolled from the waiver, as of the date established by the Department, if the participant: (a) No longer meets all of the criteria for waiver eligibility specified in §§A—C of this regulation; (b) Voluntarily chooses, or the participant's legal representative chooses on the participant's behalf, to disenroll from the waiver; (c) Is an inpatient for more than 30 days in a State psychiatric hospital, nursing facility, or intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID); (d) Moves to another state; or (e) Dies. (2) Reentering the Waiver. If a participant is discharged from the waiver, the same individual may reenter the waiver during the same waiver year, if the individual meets all eligibility requirements of the waiver. (3) The participant or legal representative shall be informed of the determination and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 42 CFR Part 431, Subpart E. #### Regulation .04 Program Model. *COMAR 10.09.46.04* A. The program services and supports shall: (1) Maximize the level of functioning of an individual with BI through assistance and support with independent living, self care skills, and social skills in an environment which encourages the participant's ability to make decisions about the individual's life and create opportunities for choice regarding home, school or work, and community activities; (2) Promote the use of community resources to integrate the individual into the community; (3) Provide services that are: (a) Appropriate to the age of the populations being served; (b) Offered at times and places suitable to the individuals served; and (c) Coordinated by BHAs administrative case manager with other medical rehabilitation, mental health, and primary care services that the individual is receiving; and (4) Assure that staff are available, on call, 24 hours per day, 7 days per week. B. Development of the Initial Waiver Plan of Care. Before the start of waiver services: (1) A case manager shall meet with the participant or the participant's legal representative, in person or remotely, to develop the initial waiver plan of care; (2) The case manager, the participant, or the participant's legal representative shall sign the waiver plan of care to indicate approval of its recommendations; and (3) The BHAs authorized representative shall review the initial waiver plan of care and sign to indicate approval if the plan of care is determined to be: (a) Sufficient to assure the participant's health and safety and meet the participant's needs in a community-based setting; (b) Feasible according to the specifications in the waiver plan of care; and (c) Individually cost-neutral by costing the Program no more for the participant's waiver and other Program services than the participant would have cost the Program in the alternative nursing facility or special hospital setting. C. Waiver Plan of Care. (1) The participant's waiver plan of care: (a) Preauthorizes the specific waiver services to be provided to the participant, as covered under Regulations .07—.09 of this chapter; (b) Is documented on the waiver plan of care form included in the approved waiver proposal; (c) Specifies for each preauthorized waiver service the following information, as appropriate: (i) Description of the specific service to be provided; (ii) Level of service; (iii) Service start date; (iv) Estimated duration; (v) Approved frequency and units of service to be delivered; (vi) Approved service delivery mode; (vii) The provider for that service, if known; and (viii) Estimated unit costs and monthly costs; (d) Describes other Program services recommended for the participant; (e) Evaluates the participant's total costs to the Program, to ensure the participant's cost-neutrality as compared to the cost to the Program for the individual in the alternative nursing facility or special hospital setting; and (f) Is subject to the BHAs approval. (2) A participant shall be given freedom of choice among all qualified and available providers for each service included in the participant's waiver plan of care. D. Periodic Review of the Waiver Plan of Care. (1) At least every 12 months or more frequently if determined necessary by the BHA: (a) A case manager and the participant or the participant's legal representative shall review the waiver plan of care and revise it as necessary; (b) The case manager and the participant or the participant's legal representative shall sign the waiver plan of care, as revised, to indicate approval of its recommendations; and (c) The BHA or its authorized representative shall review the revised waiver plan of care, and if the plan of care is determined to meet all of the criteria specified in §C(3) of this regulation, sign to indicate approval. (2) Periodic reviews and updates shall take place to: (a) Determine the appropriateness and adequacy of the participant's services; and (b) Ensure that the furnished services are consistent with the services needed for the participant's disability. #### Regulation .05 Conditions for Provider Participation — General. *COMAR 10.09.46.05* General requirements for participation in the Medical Assistance Program as a provider of BI waiver services are that the provider, with the exception of a medical day care provider, shall: A. Be approved by the BHA as meeting the requirements and able to provide the services specified in this chapter; B. Have a provider agreement in effect; C. Meet all the conditions for participation in COMAR 10.09.36, except as otherwise specified in this chapter; D. Have demonstrated experience in the provision of services to individuals with BI as evidenced by: (1) Having: (a) A history of serving individuals with brain injury for at least the past 2 years; (b) A program of specialized services appropriate for the needs of individuals with brain injury; and (c) Availability of licensed healthcare professionals with experiences in the provision of services to individuals with brain injury to supervise, train, or consult with program staff regarding the needs of waiver participants; or (2) Accreditation by CARF for the provision of brain injury services; E. Verify the licenses or credentials of all agencies and individuals who render services on the provider's behalf under this chapter, and have a copy of the licenses or credentials available for inspection; F. Assure that direct care workers who render services under this chapter: (1) Receive oversight from an appropriately licensed or certified health care professional; and (2) Are determined by the provider as qualified to meet the participants' needs; G. Provide an annual continuing education program approved by BHA for all staff working with waiver participants on the needs of individuals with BI that may include: (1) Types of brain injury; (2) Behavioral, emotional, cognitive, and physical changes after brain injury; and (3) Strategies for compensation and remediation of deficits caused by a brain injury; H. Provide services in accordance with the requirements of Regulation .04 of this chapter and all applicable federal, State, and local laws and regulations; I. Agree to provide and bill BHA or its authorized representative for only those services covered under this chapter which have been preauthorized in the participant's waiver plan of care; J. Be ineligible to participate in the BI Waiver if the provider or any of its current or previous principals have overpayments that remain due and owing to the Department; K. Provide services in person, except as authorized by the Department; and L. If providing services via virtual supports, comply with the requirements established in Regulation .09-1 of this chapter. #### Regulation .06 Conditions for Provider Participation — Specific. *COMAR 10.09.46.06* A. Provider of Residential Habilitation or Rehabilitation Services. To provide the services covered under Regulation .07 of this chapter, the provider agency shall: (1) Operate a community-based program of residential habilitation or rehabilitation services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.08 for the Community Residential Services Program; (2) Meet the participant's needs for room and board and clothing, although these services are not reimbursed by the Program; and (3) If the facility is covered by §1616(e) of the Social Security Act, comply with applicable State standards that meet the requirements of 45 CFR Part 1937 for board and care facilities. B. Provider of Day Habilitation Services. To provide the services covered under Regulation .08 of this chapter, the provider agency shall operate a community-based program of day habilitation services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.07, Vocational and Day Services Program Service Plan. C. Provider of Supported Employment Services. To provide the services covered under Regulation .09 of this chapter, the provider agency shall operate a community-based program of supported employment services that is: (1) Licensed by the Department's Office of Health Care Quality under COMAR 10.22.07, Vocational and Day Services Program Services Plan; or (2) Approved by the Department's Office of Health Care Quality under COMAR 10.21.28, Mental Health Vocational Programs. D. Provider of Individual Support Services. To provide the services covered under Regulation .09-1 of this chapter, the provider agency shall operate a community-based program of individual support services that is licensed by the Department's Office of Health Care Quality under COMAR 10.22.06 for Family and Individual Support Services. E. Provider of Medical Day Care Services. (1) To provide the services covered under Regulation .09-2 of this chapter, the provider shall meet the: (a) Licensure requirements as provided in COMAR 10.12.04; and (b) Requirements of COMAR 10.09.07. (2) Medical day care providers are not required to meet the conditions of Regulation .05 of this chapter. #### Regulation .07 Covered Services — Residential Habilitation Services. *COMAR 10.09.46.07* A. The residential habilitation services covered under this regulation shall be provided in a community-based residential facility. B. The covered services shall include: (1) Habilitative services to assist a participant in acquiring, regaining, retaining, or improving the self-help skills related to activities of daily living and the socialization and adaptive skills which are necessary to reside successfully in home and community-based settings; (2) Supervision and support, up to 24 hours a day, in a residence, based on the individual's plan of care; and (3) Any of the following additional services which are medically necessary to prevent the participant's institutionalization and are not otherwise covered for the participant by the Program or another payer: (a) Nursing supervision, in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11 for any medication administration or other delegated nursing functions provided to the participant in the residence by a direct care worker; and (b) Behavior intervention services. C. The residential habilitation services provider shall provide daily coordination of the participant's clinical treatment, rehabilitation, health, and medical services with the other providers of BI waiver services and the BI waiver case manager. D. Levels of Service. (1) Services provided in a residential program shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA. (2) Level 1 requires a minimum of 1:3 staff to participant ratio during day and evening shifts and nonawake supervision during overnight shift or an awake staff person covering more than one site during the overnight shift. The participant shall meet nursing facility or special hospital level of care. (3) Level 2 requires a minimum of 1:3 staff to participant ratio during day and evening shifts and awake, on-site supervision during overnight shift. The participant shall meet nursing facility or special hospital level of care. (4) Level 3 requires a 1:1 staff to participant ratio during day and evening shifts and awake on-site supervision during overnight shift. The participant shall meet special hospital level of care. #### Regulation .08 Covered Services — Day Habilitation Services. *COMAR 10.09.46.08* A. The day habilitation services covered under this regulation shall be provided in a nonresidential setting, separate from the home or facility in which the participant resides. B. The covered services, as defined in this chapter shall include: (1) Habilitative or rehabilitative services to assist a participant in acquiring, regaining, retaining, or improving the self-help skills related to activities of daily living and the social and adaptive skills, which are necessary to reside successfully in home and community-based settings; (2) Meals furnished as part of the program; (3) Any of the following additional services which are provided at the provider's site, are medically necessary to prevent the participant's institutionalization, and are not otherwise covered for the participant by the Program or another payer: (a) Nursing supervision, in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11 for any medication administration or other delegated nursing functions provided to the participant by a qualified direct care worker; and (b) Behavior intervention services; and (4) Transportation between a participant's residence and the provider's site, or between habilitation sites if the participant receives habilitation services in more than one place. C. Day habilitation services shall regularly be provided 4 or more hours per day on a regularly scheduled basis for 1 or more days per week, unless provided as an adjunct to other day activities included in the participant's waiver plan of care. D. Day habilitation services shall focus on enabling the participant to regain, attain, or maintain the participant's maximum functional level. E. The provider shall provide services in collaboration with the participant's other BI waiver services, clinical treatment, rehabilitation, and health and medical services. F. Levels of Service. (1) Services provided in a day habilitation program shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA. (2) Level 1 requires a minimum of 1:6 staff to participant ratio. The participant shall meet nursing facility or special hospital level of care. (3) Level 2 requires a minimum of 1:4 staff to participant ratio. The participant shall meet nursing facility or special hospital level of care. (4) Level 3 requires a minimum of 1:1 staff to participant ratio. The participant shall meet special hospital level of care. G. The program under this regulation does not cover recreational activities which are not related to specific treatment goals or are solely diversional. #### Regulation .09 Covered Services — Supported Employment Services. *COMAR 10.09.46.09* A. The supported employment services covered under this regulation shall be provided in nonresidential community settings, separate from the home or facility in which the participant resides. B. The covered services shall: (1) Include a work program that includes supports necessary for the participant to achieve desired outcomes established in the waiver plan of care; (2) Include rehabilitation activities needed to sustain the participant's job including support and training; (3) Consist of training, skill development, and paid employment for participants: (a) For whom competitive employment at or above the minimum wage is unlikely; and (b) Who, because of disabilities, need intensive ongoing support to perform in a work setting; (4) Be provided to help individuals obtain and maintain paid work in integrated community settings; and (5) Include transportation or the coordination of transportation between a participant's residence and the supported employment job site. C. Levels of Service. (1) Services shall be provided and reimbursed at one of three levels of service, as preauthorized in the participant's waiver plan of care approved by the BHA. (2) Level 1 requires that staff members provide daily contacts to the waiver participant. The participant shall meet nursing facility or special hospital level of care. (3) Level 2 requires that staff members provide a minimum of 1 hour of direct support per day. The participant shall meet nursing facility or special hospital level of care. (4) Level 3 requires that staff members provide continuous support for a minimum of 4 hours of service per day. The participant shall meet special hospital level of care. D. When provided at a work site where individuals without disabilities are employed, services shall only include the adaptations, supervision, and training required by the participants as a result of their disabilities, not the supervisory activities rendered as a normal part of the business setting. E. The Program may not reimburse for the following: (1) Incentive payments, subsidies, or unrelated incentive payments made to an employer to encourage or subsidize the employer's participation in a supported employment program; (2) Payments that are passed through to participants in a supported employment program; or (3) Payments for vocational training that is not directly related to a participant's supported employment program. #### Regulation .09-1 Covered Services — Individual Support Services. *COMAR 10.09.46.09-1* A. Individual support services, as defined in Regulation .01B of this chapter, shall be provided in a participant's own home or their community. B. The service involves the training and development of compensatory strategies and skills such that a waiver participant may learn to initiate and complete activities on their own to fully engage in their community, live independently, and compensate for cognitive and behavioral deficits related to short term memory, planning, attention, concentration, impulse control, and judgment, with the intended goal of minimizing the level of staff support the individual needs over time and preventing institutionalization. C. The provider shall provide services in collaboration with the participant's other BI waiver services, clinical treatment, and health and medical services. D. Individual support services shall be provided as pre-authorized by BHA and included in the waiver plan of care and provided in 15-minute units. E. Services may be provided in-person or via virtual supports as determined appropriate by the Department. F. Providers delivering services via virtual supports: (1) Shall ensure the participant's rights of privacy, dignity, and respect, and freedom from coercion and restraint; and (2) May provide direct support via virtual supports according to the following requirements and restrictions: (a) Virtual supports do not isolate the participant from integration in the community or interacting with people without disabilities; (b) The use of virtual supports is based on the participant’s preferences, has been agreed to by the participant and their team, and is outlined in the Plan of Service (POS); (c) Virtual supports may not be used for the provider's convenience; (d) The use of virtual supports and the service delivery method shall be documented per State requirements, policies, and guidance; (e) Text messaging and emailing do not constitute virtual supports; (f) The virtual supports shall comply with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and their applicable regulations to protect the privacy and security of the participant’s protected health information; (g) ISS may not be provided entirely via virtual supports; (h) Virtual supports shall allow flexibility of service delivery and supplement in-person direct supports as recommended and monitored by the case manager; (i) The provider shall develop, maintain, and enforce written policies, approved by BHA, which address their procedures for ensuring: (i) The participant’s rights of privacy, dignity, and respect, and freedom from coercion and restraint; (ii) The virtual supports meet applicable information security standards; and (iii) Their provision of virtual supports complies with applicable laws governing individuals’ right to privacy; (j) The provider shall train direct support staff on their policies and advise participants and their person-centered planning teams regarding the policies that indicate how a participant’s needs, including health and safety, will be addressed safely via virtual supports; (k) The virtual supports shall meet all federal and State requirements, policies, guidance, and regulations; (l) The provider shall ensure that virtual supports are accessible to the participant and provide in-person trainings, prior to the initiation of virtual services, to help the participant learn to use the required technology independently; and (m) Video cameras/monitors are not permitted in bedrooms and bathrooms. #### Regulation .09-2 Covered Services — Medical Day Care Services. *COMAR 10.09.46.09-2* A. Covered medical day care services are those set forth in COMAR 10.09.07. B. A unit of service is a minimum of 4 hours present at the medical day care center. #### Regulation .10 Conditions for Reimbursement. *COMAR 10.09.46.10* The Department shall reimburse for services covered under this chapter if the services are: A. Provided to a participant who meets the qualifications for eligibility specified in Regulations .02 and .03 of this chapter; B. Preauthorized in the participant's waiver plan of care by the BHA, as being reasonable and medically necessary to prevent institutionalization; C. Provided by an approved provider which meets the conditions for participation in Regulations .05 and .06 of this chapter; and D. Rendered pursuant to: (1) The relevant definition of covered services in Regulation .01 of this chapter; (2) All other requirements specified in this chapter and COMAR 10.09.36; and (3) The waiver proposal and any amendments to it approved by the Secretary of the U.S. Department of Health and Human Services. #### Regulation .11 Limitations. *COMAR 10.09.46.11* A. Reimbursement shall be made by the Program only if all of the requirements of this chapter are met. B. Reimbursement may not be made by the Program for a waiver service furnished before: (1) Enrollment of the participant in the waiver; (2) Development of the participant's waiver plan of care; and (3) Inclusion of the specific service in the participant's approved waiver plan of care. C. The Program shall reimburse for a participant not more than: (1) One unit of residential habilitation services for a date of service; (2) One unit of day habilitation per day; (3) One unit of supported employment per day; (4) A combined maximum of seven units of supported employment and day habilitation per week; or (5) 32 units of individual support services for a date of service. D. The Program does not cover the following: (1) Room and board for the participant; (2) Room and board for an unrelated personal caregiver who lives with the participant; (3) Direct payments to the participant's family; (4) Respite care for a participant residing in an out-of-home facility; (5) Activities or supervision reimbursed by a source other than Medicaid; (6) Payment for day habilitation on the same date of service as medical day care under COMAR 10.09.07; (7) Payment for day habilitation on the same date of services as on-site psychiatric rehabilitation as defined in COMAR 10.21.21 and COMAR 10.21.25; (8) Payment for residential habilitation on the same date of service as personal care under COMAR 10.09.20; (9) Payment for residential habilitation on the same date of service as residential rehabilitation services as defined in COMAR 10.21.22; (10) Payment for supported employment on the same date of service as mental health vocational supported employment as defined in COMAR 10.21.28; (11) Payment for individual support services on the same day as residential habilitation services as defined in Regulation .01B of this chapter; or (12) Payment for individual support services on the same day as family and individual support services as defined in Regulation .01B of this chapter. #### Regulation .12 Payment Procedures. *COMAR 10.09.46.12* A. Request for Payment. (1) An approved provider, with the exception of a medical day care provider, shall submit requests for payment to BHA or its authorized representative for the services covered under this chapter, according to procedures set forth in COMAR 10.09.36.04 or otherwise established by the Department. Medical day care providers shall submit requests for payment to the Department in accordance with COMAR 10.09.07.08. (2) The provider shall: (a) Bill the Department in accordance with the payment methodology specified in §C of this regulation; (b) Accept payment from the Department as payment in full for the services covered under this chapter and make no additional charge for the covered services to the participant or any other party; and (c) Submit a request for payment in a manner approved by the Department, which includes the: (i) Date or dates of service; (ii) Participant's name and Medicaid number; (iii) Provider's name, location, and Program identification number; (iv) Type, procedure code or codes, and unit or units of covered services provided; and (v) Amount of reimbursement requested. B. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. C. Payments. (1) Payments shall be made only to a qualified provider for services covered under this chapter which are rendered to a participant. (2) The Program shall pay according to the following fee-for-service schedule: (a) Residential habilitation reimbursed at: (i) $305.51 per day for Level 1 effective July 1, 2024; (ii) $404.52 per day for Level 2 effective July 1, 2024; and (iii) $559.63 per day for Level 3 effective July 1, 2024; (b) Day habilitation reimbursed at: (i) $78.88 per day for Level 1 effective July 1, 2024; (ii) $137.59 per day for Level 2 effective July 1, 2024; and (iii) $193.57 per day for Level 3 effective July 1, 2024; (c) Supported employment reimbursed at: (i) $46.80 per day for Level 1 effective July 1, 2024; (ii) $78.88 per day for Level 2 effective July 1, 2024; and (iii) $193.57 per day for Level 3 effective July 1, 2024; and (d) Individual support services (ISS): reimbursed at the rate of $9.5666 per 15 minutes effective July 1, 2024; and (e) Individual support services—virtual: reimbursed at the rate of $9.5666 per 15 minutes effective July 1, 2024. (3) The Program shall pay for medical day care services in accordance with COMAR 10.09.07 and the participant's approved plan of care. (4) Program rates specified in this regulation shall increase each fiscal year through FY 2026, subject to the limitations of the State budget. #### Regulation .13 Recovery and Reimbursement. *COMAR 10.09.46.13* Recovery and reimbursement under this chapter are as set forth in COMAR 10.09.36.07 and COMAR 10.09.07.09. #### Regulation .14 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.46.14* Cause for suspension or removal and imposition of sanctions under this chapter are as set forth in COMAR 10.09.36.08. #### Regulation .15 Appeal Procedures. *COMAR 10.09.46.15* A. Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and COMAR 10.01.04. B. Provider appeal procedures under this chapter are set forth in COMAR 10.09.36.09. #### Regulation .16 Interpretive Regulation. *COMAR 10.09.46.16* Interpretation of this regulation is subject to COMAR 10.09.36.10. ### Chapter 47 — Disproportionate Share Hospitals **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.04 adopted as an emergency provision effective June 1, 1992 (19:12 Md. R. 1131); adopted permanently September 1, 1992 (19:17 Md. R. 1607) **Administrative History:** Regulation .03 amended as an emergency provision effective February 17, 1993 (20:5 Md. R. 511); amended permanently effective May 24, 1993 (20:10 Md. R. 852) **Administrative History:** Regulation .03D amended effective September 25, 2017 (44:19 Md. R. 896) **Administrative History:** Regulation .03H adopted effective June 24, 2013 (40:12 Md. R. 1042) #### Regulation .01 Definitions. *COMAR 10.09.47.01* A. In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.06.01 are applicable to this chapter. B. Terms Defined. (1) “Charity care” means hospital care for which the costs are not reimbursed through any patient or third party. (2) “Charity care inpatient costs” means hospital costs that are not reimbursed through any patient or third party, reduced by the amount of gifts, restricted grants, or income from endowments. For the purposes of this chapter, third party payments include Medicaid payments for the cost of care, but do not include disproportionate share payments. (3) “Low-income hospital costs” means the sum of a hospital's: (a) Inpatient Medicaid costs; (b) State and local government inpatient cash subsidies; and (c) Charity care inpatient costs. (4) “Low-income utilization rate” means, for a hospital, the sum of: (a) A fraction, expressed as a percentage: (i) The numerator of which is the sum, for a fiscal year, of the total revenues paid the hospital for patient services under a Medical Assistance Program, and the amount of cash subsidies for patient services received directly from State and local governments, and (ii) The denominator of which is the total amount of revenues of the hospital for patient services, including the amount of the cash subsidies in the fiscal year; and (b) A fraction, expressed as a percentage: (i) The numerator of which is the total amount of the hospital's charges for inpatient hospital services that are attributable to charity care in a fiscal year, less the portion of any cash subsidies described in §B(4)(a)(i) of this regulation in the period reasonably attributable to inpatient hospital services, and (ii) The denominator of which is the total amount of the hospital's charges for inpatient hospital services in the hospital in the period reasonably attributable to inpatient hospital services. (5) “Medicaid cost” means an amount equal to Medicaid payments by the Medicaid program. (6) “Medicaid inpatient utilization rate” means a fraction, expressed as a percentage: (a) The numerator of which is the hospital's number of inpatient days attributable to patients who were eligible for Medical Assistance benefits under Title XIX of the Social Security Act for a fiscal year; and (b) The denominator of which is the total number of the hospital's inpatient days for the fiscal year in §B(6)(a) of this regulation. (7) “State and local government inpatient cash subsidies” means the payments for hospital costs from State or local government health agencies that are not intended as reimbursement for costs directly associated with particular patients, but are provided more generally for operating costs of the institution. These subsidies do not include Medicaid payments or disproportionate share payments. #### Regulation .02 Disproportionate Share Hospitals. *COMAR 10.09.47.02* A. A Maryland hospital is considered a disproportionate share hospital for purposes of a disproportionate share payment if the hospital's: (1) Medicaid inpatient utilization rate is at least one standard deviation above the mean Medicaid inpatient utilization rate for Maryland hospitals that are Medicaid providers; or (2) Low-income utilization rate exceeds 25 percent. B. To be considered a disproportionate share hospital, a hospital shall have at least two obstetricians with staff privileges who have agreed to provide obstetrical services to individuals who are entitled to Medical Assistance for services under Title XIX of the Social Security Act. C. The requirements set forth in §B of this regulation do not apply to a hospital if: (1) Inpatients are predominately individuals younger than 18 years old; or (2) The hospital did not provide nonemergency obstetric services as of December 22, 1987. D. Data for §A(1) and (2) of this regulation relate to the State fiscal year occurring 2 years before the fiscal year during which payments are made. #### Regulation .03 Disproportionate Share Payment. *COMAR 10.09.47.03* A. Free-Standing Acute General, Chronic, or Pediatric/Rehabilitation Hospitals. (1) Except as set forth in §A(2) of this regulation, the disproportionate share payment for disproportionate share hospitals that are free-standing hospitals licensed as acute general, chronic, or jointly as pediatric and rehabilitation equals an amount determined in accordance with 42 CFR §412.106, but only if the hospital qualifies as a disproportionate share hospital under 42 CFR §412.106. (2) Free-standing hospitals that are approved by the Program for reimbursement according to rates established by the HSCRC receive a bad debt allowance, which is recognized as a disproportionate share payment equal to or greater than the amount set forth in §A(1) of this regulation, and an additional payment may not be made under this chapter. B. The disproportionate share payment rate relating to Program payments on or after October 1, 1992 for free-standing hospitals licensed exclusively as: (1) Psychiatric with charity care inpatient costs: (a) Exceeding 40 percent of total inpatient hospital costs equals the greater of the: (i) Hospital's annual low income costs divided by its annual inpatient Medicaid costs, minus 1, all multiplied by 2, and then multiplied by its inpatient Medicaid payment, or (ii) Minimum payment required by federal law; (b) Less than or equal to 40 percent of total inpatient hospital costs equals the minimum payment required by federal law; (2) Rehabilitation with charity care inpatient costs: (a) Exceeding 20 percent of total inpatient hospital costs equals the greater of the: (i) Hospital's annual low income costs divided by its annual inpatient Medicaid costs, minus 1, multiplied by its inpatient Medicaid payment, or (ii) Minimum payment required by federal law; (b) Less than or equal to 20 percent of total inpatient hospital costs equals the minimum required by federal law. C. If a hospital qualifies under both §§A(2) and B of this regulation, it is governed by §A(2) of this regulation. D. Payments according to §A or B of this regulation shall be: (1) Based on data on annual low-income hospital costs, annual inpatient Medicaid costs, and data pertaining to 42 CFR §412.106 from the complete State fiscal year occurring 2 years before the fiscal year during which payments are made; (2) Made in one or more payments covering the complete fiscal year; and (3) Made to appropriate hospital providers that comply with all regulations set forth in COMAR 10.09.92—10.09.95. E. Out-of-State hospitals determined by the host state Medicaid Program to be a disproportionate share hospital shall be paid a disproportionate share adjustment as determined by the host state Medicaid Program, with a hospital's total adjustment not to exceed 1 percent of the total Maryland Medical Assistance payments to that hospital in a fiscal year. F. Qualification Requirements. (1) Except as set forth in §F(2) of this regulation, to qualify as a disproportionate share hospital, a hospital shall supply to the Program, 6 months before the start of the applicable fiscal year: (a) Information necessary to determine if the hospital qualifies as a disproportionate share hospital; and (b) Data required under §D(1) of this regulation. (2) For payments in fiscal year 93, the information required in this section shall be presented to the Department within 10 days of the effective date of these regulations. G. A free-standing hospital licensed exclusively as psychiatric or rehabilitation for at least 2 years, that has not been a Maryland Medicaid provider for at least 2 years, shall receive a disproportionate share payment, for any year, not greater than the hospital's low-income hospital costs in the complete State fiscal year occurring 2 years before the fiscal year during which payments are made. H. If it is determined that a payment made to any hospital under this regulation exceeds the actual amount of uncompensated care and would result in reverting funds to CMS, the overpayment shall be used for another provider that received less than that provider was eligible to receive. The redistribution shall be available to all providers that are eligible for disproportionate share payments except those whose rates are set by HSCRC. #### Regulation .04 Interpretive Regulation. *COMAR 10.09.47.04* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 48 — Targeted Case Management for People with Developmental Disabilities **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.18 adopted as an emergency provision effective June 23, 1992 (19:14 Md. R. 1276); adopted permanently effective October 12, 1992 (19:20 Md. R. 1815) **Administrative History:** Regulations .01—.03 and .06 amended and Regulation .12 repealed as an emergency provision effective December 9, 1994 (21:26 Md. R. 2183); adopted permanently effective March 27, 1995 (22:6 Md. R. 474) **Administrative History:** Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .09A amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .10A amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulations .01—.18 under Case Management for Individuals with Developmental Disability repealed and new Regulations .01—.12 under Targeted Case Management for People with Intellectual and Developmental Disabilities adopted effective July 8, 2013 (40:13 Md. R. 1074) **Administrative History:** Chapter name, Targeted Case Management for People with Intellectual and Developmental Disabilities amended to be Targeted Case Management for People with Developmental Disabilities effective June 8, 2015 (42:11 Md. R. 723) **Administrative History:** Regulation .01B amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .02 amended effective December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .03 amended effective December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .03B amended effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .04 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .05 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .06 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .07 amended effective June 8, 2015 (42:11 Md. R. 723); December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .08 amended effective June 8, 2015 (42:11 Md. R. 723); June 20, 2016 (43:12 Md. R. 666); December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .08B amended effective August 14, 2017 (44:16 Md. R. 809); February 12, 2018 (45:3 Md. R. 156); December 31, 2018 (45:26 Md. R. 1243); December 30, 2019 (46:26 Md. R. 1164); August 21, 2023 (50:16 Md. R. 276); September 16, 2024 (51:18 Md. R. 809); November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .10 amended effective June 8, 2015 (42:11 Md. R. 723) #### Regulation .01 Definitions. *COMAR 10.09.48.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Annually” means within 365 days. (2) “Applicant” means the individual who files an application for services with the DDA. (3) “Community Coordination Services” means provision of core services to individuals receiving ongoing DDA funding for comprehensive community services. (4) “Community resources” means generic, local, State, or federal programs, services, benefits, and supports. (5) “Comprehensive assessment” means an assessment of the applicant’s needs and supports to enable the DDA to determine the applicant’s eligibility for DDA funding of comprehensive community services. (6) Comprehensive Community Services. (a) “Comprehensive community services” means services funded by the DDA for residential, day, employment, or supports services. (b) “Comprehensive community services” does not mean funding for low intensity support services or coordination of community services. (7) “Contact” means a face-to-face meeting, phone conversation, or written correspondence related to the covered services in this chapter. (8) “Coordination of community services” means the provision of targeted case management services that assist participants in gaining access to the full range of medical assistance services, as well as access to any additional needed generic, medical, social, habilitative, employment, recreational, housing, financial, counseling, legal, educational, and other support services. (9) “Coordinator of community services” means an individual employed by the coordination of community services agency to assist participants in selecting, obtaining, and monitoring the most responsive and appropriate services and supports. (10) “Coordination of community services supervisor” means an individual who is employed to oversee coordination of community services and performance of coordinators of community services. (11) “Core services” means the following community services: (a) Comprehensive assessment; (b) Development of the person-centered plan; (c) Referrals and related activities; and (d) Monitoring and follow-up. (12) “Critical incident” means a reportable event that presents an immediate and serious threat of injury, harm, impairment, or death of an individual. (13) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (14) “Developmental Disabilities Administration (DDA)” means that agency of the Department which, under Health General Article, Title 7, Annotated Code of Maryland, is charged with the responsibility for providing services to individuals with developmental disability. (15) “Developmental disability” has the same meaning as set forth in Health-General Article, §7-101, Annotated Code of Maryland. (16) “Entity” means a facility, agency, organization, department, office, corporation, partnership, group, or individual. (17) “Generic” means programs, services, or supports which are available to the community at large. (18) “Goal” means measurable activity that is required to achieve progress toward an outcome. (19) “Medicaid waiver programs” means any program under §1915(c) of the Social Security Act. (20) “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (21) “Most integrated setting” means a setting that enables a participant with a disability to interact with nondisabled individuals other than staff to the fullest extent possible. (22) “Outcome” means tangible results of goals that reflect the desired quality of life as defined by the individual. (23) “Participant” means an individual who meets the qualifications for participation in coordination of community services as specified in Regulation .03 of this chapter. (24) Person-Centered Plan. (a) “Person-centered plan” means a written plan that is developed through a planning process driven by the participant with a developmental disability to: (i) Identify the participant’s goals and preferences; (ii) Identify services to support the participant in pursuing the participant’s personally defined outcomes in the most integrated community setting; (iii) Direct the delivery of services that reflect the participant’s personal preferences and choice; and (iv) Identify the participant’s specific needs that must be addressed to ensure the participant’s health and welfare. (b) “Person-centered plan” includes an individual plan as referenced in COMAR 10.22. (25) “Person-directed supports” means service and supports that empower the participant, and the legally authorized representative on the participant’s behalf, to direct the development and implementation of a plan of supports and services that meet the participant’s personal goals. (26) Place of Service. (a) “Place of service” means the place where participants receive services. (b) “Place of service” includes but is not limited to the participant’s home, day program, group home, alternate living arrangement, or place of employment. (27) “Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (28) “Provider” means an entity that meets the conditions for participation specified in Regulation .04 of this chapter, and is authorized by DDA to provide coordination of community services. (29) “Reportable events” means specified incidents and complaints noted in the DDA Policy on Reportable Incidents and Investigations (PORII), as required under COMAR 10.22.02.01 and established to ensure the health, safety, and welfare of participants receiving services from DDA-funded providers. (30) “Representative” means a person who: (a) Is chosen by the participant to represent the participant’s needs and may include: (i) A family representative; (ii) An informal caregiver; or (iii) Any other individual chosen by the participant; or (b) Is recognized by the DDA as a legally appointed guardian qualified to act on the participant’s behalf with respect to services covered under this chapter. (31) “Service record” means all past and current health, eligibility, request for service change, service funding plan, person-centered plan, and coordination of community services documents and records. (32) “State programs” means programs, services, or supports offered by the State. (33) Targeted Case Management. (a) “Targeted case management” means an optional service allowed under federal Medicaid rules which includes services to assist target populations of Medicaid participants to gain access to needed medical, social, educational, and other services. (b) “Targeted case management” includes: (i) Performance of a comprehensive assessment and periodic reassessment of participant needs, to determine the need for any medical, educational, social, or other services; (ii) Provision of waiting list coordination services; (iii) Provision of community coordination services; and (iv) Provision of transition coordination services. (34) “Transition Coordination Services” means provision of core services to participants transitioning to the community from an institution. (35) “Unit of service” means 15 minutes of services covered under this chapter, excluding the comprehensive assessment. (36) “Waiting list” means participants found eligible for services in the crisis resolution, crisis prevention, or current request priority category as set forth in COMAR 10.22.12.07B. (37) “Waiting List Coordination Services” means provision of core services to participants on the DDA waiting list. #### Regulation .02 Certification Requirements. *COMAR 10.09.48.02* The provider shall meet all applicable certification requirements as set forth in COMAR 10.22.02 unless otherwise authorized by the Developmental Disabilities Administration. #### Regulation .03 Participant Eligibility. *COMAR 10.09.48.03* To be eligible for services covered under this chapter, a participant or applicant shall: A. Apply to be a Medical Assistance Program participant or be Medical Assistance Program eligible; and B. Either: (1) Have applied for services from the Developmental Disabilities Administration but not yet had their eligibility determined; or (2) Be eligible for funding from the DDA as set forth in COMAR 10.22.12, and meet one of the following conditions: (a) Be determined to have a developmental disability and currently on the DDA waiting list; (b) Be receiving comprehensive community services funded by the DDA; or (c) Be determined to have a developmental disability and in the process of transitioning to the community. #### Regulation .04 Conditions for Participation — General. *COMAR 10.09.48.04* A. In this chapter, targeted case management services are referred to as coordination of community services. B. Providers shall meet all the conditions for participation as set forth in COMAR 10.09.36.03. C. Administrative and Professional Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall: (1) Be incorporated in the State in good standing with the Maryland Department of Assessments and Taxation unless operating as a local health department; (2) Have a board of directors or local advisory board in accordance with COMAR 10.22.02; (3) Be selected by DDA as an approved provider of coordination of community services, as evidenced by an executed DDA-approved contract; (4) Participate in all transition and rollout processes as determined by the DDA; (5) Maintain a standard 8-hour operational day Monday through Friday and have flexible staffing hours that include nights and weekends to accommodate the needs of participants receiving coordination of community services; (6) Maintain a toll-free number, unless otherwise authorized by the DDA, and an accessible communication system in accordance with the Americans with Disabilities Act of 1990; (7) Maintain a communication system that is accessible for participants with limited English proficiency; (8) Provide alternative communication methods to serve the needs of participants receiving coordination of community services and their family members; (9) Have a means for participants, their families, community providers, and DDA staff to contact the coordination of community services designated staff directly in the event of an emergency and at times other than standard operating hours; (10) Annually advise participants of their right to choose among qualified providers of services including coordination of community services; (11) Comply with all State and federal statutes and regulations; (12) Maintain a participant’s record for a minimum of 6 years after the record is made; (13) Notify the DDA immediately in writing of any critical incidents that affect the health, safety, and welfare of a participant, as well as administrative and quality of care complaints as required by the DDA Policy on Reportable Incidents and Investigations; and (14) Submit required documents and forms to the Department as requested. D. Operational Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall: (1) Submit a program service plan that includes: (a) Scope of work; and (b) Proposed staffing plan, including staff and staff-to-participant ratios; (2) Complete and submit an initial and annual written quality assurance plan to the DDA which meets the requirements in COMAR 10.22.02.14 and includes the following: (a) Customer service plan that includes strategies and services to meet the needs of participants, their families or caretakers, and providers; and (b) Self-assessment, remediating, monitoring, reporting, and system improvements strategies, or other quality and compliance actions related to coordination of community services; (3) Submit monthly service delivery statistical reports as defined by the Department by the 15th of each month unless otherwise directed by the Department; (4) Submit quarterly updates, as defined by the Department, on progress on quality assurance plans by October 15, January 15, and April 15 of each year unless otherwise directed by the Department; (5) Submit to the Department annually by July 15th the final quality plan summary reports unless otherwise directed by the Department; (6) Maintain a thorough understanding and knowledge of: (a) Eligibility requirements, application procedures, and scope of services of local, State, and federal resources and programs which are applicable to participants eligible for DDA services; (b) Medicaid, Medicaid waiver programs, and DDA eligibility requirements, application procedures, and service delivery systems; and (c) Person-centered planning methodology and person-centered plan development and monitoring; (7) Coordinate services with multiple long-term service and support systems; (8) Maximize resources to the greatest possible extent; and (9) Obtain authorization from the DDA before providing any coordination of community services to any participant; (10) In providing coordination of community services, meet the following requirements: (a) All participants referred for coordination of community services by the DDA shall be contacted within 3 business days of receipt of referral unless otherwise authorized by the DDA; (b) A face-to-face meeting with the referred participant shall be arranged at a time and location convenient for the referred individual during the first contact; (c) A face-to-face meeting shall occur within 7 business days of the initial contact unless the participant’s health or schedule conflicts; (d) If applicable, the provider shall document in the case record reasons why face-to-face meetings did not occur within the required timeframe and share the document as requested by the DDA or its designee; (e) Authorization for specific coordination of community services shall be based on referrals from the DDA regional office; and (f) In the event of emergencies, the participant referred for coordination of community services by the DDA shall be contacted by the coordinator of community services as circumstances require or as requested by the DDA. E. Participant Record. The provider shall maintain a record on each participant which meets the Program’s requirements and which includes: (1) The name of the participant; (2) The dates of the coordination of community services; (3) The name of the provider agency and the name of agency employee providing the coordination of community service; (4) The name, address, and telephone number of the individual or individuals to be contacted in case of emergency; (5) A completed person-centered plan; (6) The comprehensive assessment as applicable; (7) Documentation that the coordinator of community services provided the participant with a choice among qualified providers of services, including coordination of community services; (8) Documentation that indicates whether the participant has declined services in the person-centered plan and the reason for declining; (9) Documentation that includes: (a) A schedule for obtaining needed services; (b) A timeline for re-evaluation of the person-centered plan not less than annually; and (c) The name and position of the individual responsible for completing tasks related to the person-centered plan; (10) Status of progress on participant-intended outcomes identified in the person-centered plan; (11) Documentation of coordination with other service systems, including: (a) Demonstrated need for other services systems; and (b) Dates of occurrences of coordination with other service systems; and (12) Documentation for each contact made by the coordinator of community services including: (a) Date and subject of contact; (b) Individual contacted; (c) Individual making the contact; (d) Contact method; (e) Nature and extent of coordination of community services provided; (f) Number of unit or units of service provided; (g) Place of service; and (h) Services referred. F. Technology Requirements. To participate in the Program as a provider of services covered under this chapter, the provider shall: (1) Utilize an electronic information system which, at a minimum: (a) Maintains confidential individual case and billing records; (b) Provides documentation of coordination of community services and number of units provided for participants receiving services; (c) Maintain a permanent history log of all entries made to the record; and (d) Adheres to applicable State and federal laws; and (2) Adhere to the following information technology requirements: (a) Use the DDA’s designated data system unless another data system is approved annually by the DDA; (b) Ensure that all management information systems: (i) Are secure from improper use, alteration, or disclosure; (ii) Utilize industry best practices for secure connection to management information systems; (iii) Secure network connections with logon only from a secured location; (iv) Prohibit users from sharing user accounts; (v) Limit access to the system and related information based on job function; and (vi) Adhere to DDA information technology data security policies, standards, and procedures when using DDA managed systems; (c) Report security violations and actual or attempted security breaches affecting the managed systems with participant information immediately but not later than 48 hours after the violation or breach; (d) Maintain and update as necessary all electronic data systems to be compatible with those of the State and, if required, work with DDA to develop a system for developing protocols for data sharing and read-only access for the DDA and its designees; and (e) Obtain written approval from the DDA before posting on any public website information that describes DDA services. G. Billing. To receive payment for services covered under this chapter, the provider shall: (1) Comply with Department’s requirements for submitting, processing, and reconciling claims for payment for services rendered under this chapter; (2) Be in good standing with the Maryland Department of Assessments and Taxation, and with its equivalent in every state in which the applicant provides services; (3) Permit the DDA or the Department or its agent, or any State or federal entity operating within its statutory authority to conduct audits and provide immediate access to all records upon request; and (4) Comply with audit requirements. H. Freedom of Choice. The provider shall place no restrictions on the participant’s freedom of choice among: (1) Providers of coordination of community services; (2) Providers of community-based services for which the participant qualifies; and (3) Service delivery models available under the DDA’s Medicaid waiver programs. I. Transfer of Service Records. For participants changing from one DDA-authorized coordination of community services provider to a different DDA-authorized coordination of community services provider, the outgoing provider shall: (1) Transfer the service record to the new provider; and (2) Share with the new provider the participant’s demographic information and the most recent person-centered plan within 5 business days of notification of transfer for the continued coordination of services. J. Provision of Services. The provider may not exercise the agency’s authority to authorize or deny DDA or other State funded services. #### Regulation .05 Conditions for Participation — Staff Requirements. *COMAR 10.09.48.05* A. Staff Capability Requirements. The provider shall: (1) Employ only personnel who are appropriately qualified as set forth in this regulation; (2) Maintain sufficient staff required to meet the needs of the participants whom the provider serves; (3) Have administrative and supervisory staff to ensure the quality of coordination of community services provided by the provider; (4) Have a management capability team, each member of which has at least 3 years of experience providing coordination of community services or management experience in human services; and (5) Maintain personnel files for each employee which includes documentation of staff qualifications as set forth in this regulation. B. Staff Training Requirements. (1) All DDA-certified coordination of community services providers shall ensure through appropriate documentation that coordination of community services staff, supervisors, and quality assurance staff receive training, as required by DDA. (2) All coordination of community services staff shall receive training on procedures, protocols, processes, and regulations as required by the DDA. C. Coordination of community services staff shall: (1) Receive required training as specified in COMAR 10.22, unless otherwise directed by the DDA, which shall be documented and made available upon request; (2) Comply with all State and federal statutes, regulations, and policies; and (3) Demonstrate competency-based skills and working knowledge in the following areas: (a) Negotiation and conflict management; (b) Crisis management; (c) Community resources including generic programs, local programs, State programs, and federal programs and resources; (d) Determining the most integrated setting appropriate to meet the participant’s needs; (e) Coordinating and facilitating planning meetings; (f) Assessing, planning, and coordinating services; (g) Assisting participants in gaining access to services and supports; (h) Monitoring the provision of services to participants; (i) Allied service delivery systems, including Medicaid, mental health, substance abuse, social services, juvenile justice, vocational rehabilitation, and corrections; and (j) Regulations governing services for participants with developmental disabilities. D. Coordination of Community Services Supervisor. The coordination of community services supervisor shall: (1) Except as stated in §F of this regulation, meet one or more of the following education requirements: (a) An advanced degree from an accredited education program in human services and 1 year of experience as set forth in §C of this regulation; or (b) A bachelor’s degree from an accredited education program in human services with 3 years experience as set forth in §C of this regulation; (2) Demonstrate experience in one or more of the following: (a) Coordinating services for participants in Medicaid or waiver programs; or (b) Coordinating services for participants with intellectual or developmental disabilities; (3) Demonstrate experience in all of the following: (a) Social services intake and referral services; (b) Data collection, analysis, and reporting; (c) Staff supervision; and (d) Management or leadership; (4) Supervise the work of coordinators of community services; and (5) Monitor the quality of services. E. Coordinator of Community Services. The coordinator of community services shall: (1) Except as stated in §F of this regulation, have: (a) A bachelor’s degree from an accredited education program in a human services field; (b) An associate’s degree with 2 years’ experience in a human services field; or (c) 7 years’ experience in a human services field; (2) Use all communication methodologies, strategies, devices, and techniques necessary, including sign language, assistive technology, or language interpreter services, to facilitate the involvement of the participant in the assessment, development, and monitoring of services and supports; (3) Ensure that each participant receives a person-centered plan that is designed to meet the individual’s needs in the most cost-effective manner; and (4) Annually advise participants of their right to choose among qualified providers of services including coordination of community services. F. Education and Experience Waiver. (1) Coordination of Community Services Supervisor. Education and experience requirements may be waived if an individual has been employed as a coordination of community services supervisor for at least 1 year as of January 1, 2014. (2) Coordinator of Community Services. Education and experience requirements may be waived if an individual has been employed as a coordinator of community services for at least 1 year as of January 1, 2014. G. An individual is ineligible for employment by a coordination of community services provider, agency, or entity in Maryland if the individual: (1) Is simultaneously employed by any MDH-licensed or MDH-certified provider agency; (2) Is on the Maryland Medicaid exclusion list; (3) Is on the federal List of Excluded Individuals/Entities (LEIE); (4) Is on the federal list of excluded parties as maintained by the System of Award Management (SAM.GOV); (5) Has been convicted of a crime of violence in violation of Criminal Law Article, §14-101, Annotated Code of Maryland; (6) Violates or has violated Health-General Article, §7-1102, Annotated Code of Maryland; or (7) Has been found guilty or been given Probation Before Judgment for a crime which would indicate behavior potentially harmful to individuals receiving services, as documented either through a criminal history records check or a criminal background check, pursuant to: (a) Health-General Article, §19-1902, et seq., Annotated Code of Maryland; and (b) COMAR 12.15. #### Regulation .06 Covered Services. *COMAR 10.09.48.06* A. Only core services shall be authorized for payment by DDA as covered coordination of community services. B. The coordinator of community services shall provide the core services listed in this regulation to every participant assigned to the coordinator. C. Comprehensive Assessment. Coordination of community services shall include a comprehensive assessment of the participant’s needs and supports to determine eligibility, in accordance with COMAR 10.22.12. The assessment shall be completed within 45 days after referral by the DDA and include: (1) A review of relevant medical and other records with the applicant or legal representative’s written consent; (2) A review of current providers of medical, social, or other support services, as appropriate; (3) Unless otherwise authorized by the DDA, a face-to-face assessment of the participant, preferably at the participant’s residence, to review: (a) Medical, developmental, and mental history, including current medications; (b) Nutritional status; (c) Emotional and behavioral status; (d) Health care coverage; (e) Living situation; (f) Personal support systems; (g) Participant goals and preferences; (h) Environmental, social, and functional status; (i) Educational history; (j) Employment and income status; (k) Health education; (l) Social support; (m) The most integrated setting appropriate to meet the participant’s needs; and (n) Any additional service needs; (4) Assistance with information-gathering such as obtaining professional evaluations and assessments necessary to document and recommend eligibility and priority for services; and (5) A completed assessment form as required by the DDA. D. Person-Centered Plan. (1) The coordinator of community services shall facilitate the person-centered plan that is designed to meet the participant’s needs, preferences, goals, and outcomes in the most integrated setting and in the most cost effective manner. (2) The person-centered plan shall: (a) Be participant-centered, outcome-oriented, and person directed, as selected by participant; (b) Comply with the requirements set forth in COMAR 10.22.05; (c) Establish a plan for emergencies; (d) Be completed within 30 business days after initial contact with the participant, and, if necessary, updated or modified within 30 business days after service initiation; (e) Be developed and written in collaboration with the participant and his or her identified representatives as appropriate; (f) Provide services in the most integrated setting; (g) Identify services needed to accomplish intended outcomes and preferences; (h) Address risks and needs identified in the comprehensive assessment; and (i) Be updated or revised: (i) As the conditions or circumstances of the participant change or as requested by the participant; and (ii) Within 365 days of the initial person-centered plan or annually. (3) Specific requirements for the person-centered plan developed for participants receiving transition coordination services are that the person-centered plan shall: (a) Address challenges related to transitioning; (b) Focus on transition from the institutional setting to the community; (c) Identify services and supports that may be available; (d) Be outcome-oriented; and (e) Include the provision of services and supports. E. Referral and Related Activities. (1) At the time of the initial meeting and any follow-up contacts, coordinators of community services shall provide information, make referrals, and assist participants with applications for services provided by: (a) Community organizations; (b) State programs; and (c) Federal programs. (2) Referral and related activities may include: (a) Assisting the participant with the completion of applications for services and programs; (b) Providing the participant with contact or other information for services provided by self-advocacy groups, recreation organizations, or social groups; (c) Assisting the participant with transitioning to new services, providers, or supports; (d) Assisting the participant with referrals, as needed; and (e) Providing education to participants and their families concerning: (i) The range of most integrated setting service and support options that may be appropriate to meet the participant’s needs and preferences; (ii) How to access services; and (iii) How to coordinate and advocate for services. F. Monitoring and Follow-Up. (1) The coordinator of community services shall provide monitoring and follow-up activities, which shall include: (a) Assessment of: (i) Services being rendered as specified in the person-centered plan; (ii) The participant’s current circumstances; (iii) Progress toward goals and intended outcomes; (iv) The participant’s referral status; and (v) The participant’s needs and supports to maintain eligibility for Medicaid, Medicaid waiver programs, DDA services, and any other relevant benefits or services; (b) Identification of new medical, health services, or other needs; (c) Recommendation of new DDA priority category as the conditions or circumstances of the participant changes, or as requested by the DDA; (d) Requests for service change and modifications of the person-centered plan as necessary to meet health and safety needs, preferences, and goals; (e) Identification of new support or resource options; (f) Review and, if necessary, revision of the plan for emergencies; (g) Monitoring of any and all reportable incidents as defined in DDA’s reportable incident policy; and (h) Application or re-application for necessary programs or services to prevent or remedy a gap in eligibility. (2) Frequency of Monitoring and Follow-up Contact. (a) For participants receiving waiting list coordination services, monitoring and follow-up contact activities shall meet the following requirements: (i) For participants who meet the criteria for the crisis resolution priority category as set forth in COMAR 10.22.12.07, minimum monthly face-to-face contacts shall be made for the first 90 days, after which face-to-face contacts will be made quarterly; (ii) For participants who meet the criteria for the crisis prevention priority category as set forth in COMAR 10.22.12.07, minimum quarterly face-to-face contacts shall be made; and (iii) For participants who meet the criteria for the current request priority category as set forth in COMAR 10.22.12.07, minimum annual face-to-face contacts shall be made. (b) Participants on the DDA waiting list shall be monitored in accordance with §F(2)(a) of this regulation unless: (i) The participant’s priority category changes; or (ii) Additional units are authorized by DDA. (c) For participants receiving community coordination services, monitoring and follow-up activities shall be performed: (i) On a minimum quarterly basis; (ii) Face to face with the participant; (iii) In different services delivery settings; and (iv) At least one time in each service delivery setting. (d) For participants receiving transition coordination services, monitoring and follow-up activities shall be performed face-to-face at least once a month for the first 90 calendar days, after which face-to-face contacts shall be made quarterly. (3) Records of monitoring activities shall: (a) Be completed in a format approved by the DDA; (b) Include descriptions of the participant’s current circumstances, progress toward goals, intended outcomes, preferences, and referral status; (c) Document new support and resource options for intake and referral; (d) Be submitted using the electronic system provided by the Department; and (e) Document all reportable events as set in the DDA’s policy on reportable incidents and investigations. #### Regulation .07 Limitations. *COMAR 10.09.48.07* A. Restrictions may not be placed on a participant’s option to receive coordination of community services. B. Coordination of community services provided under this chapter does not restrict or otherwise affect eligibility for Title XIX benefits or other available benefits or programs. C. Coordination of community services may not be: (1) Provided as an integral and inseparable part of another covered Program service; (2) Provided as an administrative function; (3) Rendered in connection with the implementation of another service authorized under §1915(b) or 1915(c) of the Social Security Act; or (4) Provided as a substitute or in duplication of another service or support. D. Unless otherwise approved by the Department, reimbursement may not be made for coordination of community services if the participant is receiving comparable case management services under any other State program. E. A participant’s coordination of community services provider may not also provide DDA-funded direct services, including meaningful day, support, and residential services for the participant. F. Service Exclusions. (1) Unless an individual is transitioning into the community, coordination of community services may not be provided to: (a) Individuals between the ages of 22 and 64 who are served in institutions for mental disease; or (b) Inmates or residents of public institutions. (2) Services of more than 180 consecutive days of a covered stay in a medical institution will not be reimbursed unless an individual is transitioning from another Medicaid program into a DDA waiver program as authorized by the DDA. G. An applicant is ineligible to be a provider if, within the preceding 10 years, the entity, its owner, or any member of its board of directors has had a provider license or certification revoked or suspended for more than 30 days, pursuant to Maryland or another state’s regulations, or has been found by a court of law to have committed fraud, abuse, intentional or negligent tort, or a criminal act. #### Regulation .08 Payment Procedures. *COMAR 10.09.48.08* A. Request for Payment. (1) Requests for payment for the services covered under this chapter shall be submitted by a provider according to procedures set forth in COMAR 10.09.36.04. (2) Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. B. Payment Rates. (1) The Department shall publish a fee schedule for services covered under this chapter, which shall be publicly available and updated at least annually or upon any changes made by the Department. (2) The Department's rates set forth in its fee schedule will apply to services covered under this chapter that are provided under either the traditional services delivery model or the self-directed services delivery model. (3) The Program's rates for covered services under this chapter shall increase on July 1 of each year, subject to the limitations of the State budget. (4) Providers shall be reimbursed within 45 business days of approved invoice for services rendered based on the rates set forth in §C(1) and (2) of this regulation. (5) For a comprehensive assessment, providers shall be reimbursed $450 per assessment. (6) For all other services rendered to Maryland Medicaid participants residing in counties other than those listed in §B(7) of this regulation, providers shall be reimbursed: (a) For dates of service January 1, 2023 through June 30, 2023, $24.56 per unit; (b) For dates of service July 1, 2023 through December 31, 2023, $25.54 per unit; (c) For dates of service January 1, 2024 through June 30, 2024, $27.50 per unit; and (d) For dates of service July 1, 2024 through June 30, 2025, $28.33 per unit. (7) Providers rendering services to Maryland Medicaid participants residing in Calvert, Charles, Frederick, Montgomery, and Prince George’s counties shall be reimbursed: (a) For dates of service January 1, 2023 through June 30, 2023, $25.86 per unit; (b) For dates of service July 1, 2023 through December 31, 2023, $26.89 per unit; (c) For dates of service January 1, 2024 through June 30, 2024, $28.96 per unit; and (d) For dates of service July 1, 2024 through June 30, 2025, $29.83 per unit. C. Changes in Rates. (1) The rates are subject to the limitations of the State budget. (2) Unless otherwise authorized, the rates may be changed on July 1 of each year beginning July 1, 2015, based on legislative action, and subject to limitations of the State budget. D. Payment Limitations. (1) Payment shall be made only to one provider for covered services rendered to a participant on a particular date of service. (2) Payment for the services covered under this chapter: (a) Shall be considered as payment in full; and (b) May not supplement or be supplemented by payment from other sources, such as the participant, family, a public program, or private agency. (3) For a comprehensive assessment, only one assessment may be reimbursed per participant, unless otherwise authorized by DDA. (4) Ongoing coordination of community services shall be billed on a scheduled determined by the Department. E. Units of Services and Limitations. (1) All coordination of community services other than the initial comprehensive assessment shall be billed to DDA in units of service. (2) DDA shall provide payment for only those coordination of community services that were authorized by DDA before the provision of the service. (3) Each fiscal year, the coordinator of community services shall complete the core services for each participant. #### Regulation .09 Recovery and Reimbursement. *COMAR 10.09.48.09* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .10 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.48.10* Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08 and 10.22.03. #### Regulation .11 Appeal Procedures. *COMAR 10.09.48.11* A. Appeal procedures for providers shall be as set forth in COMAR 10.09.36.09. B. Appeal procedures for participants shall be as set forth in COMAR 10.01.04. #### Regulation .12 Interpretive Regulation. *COMAR 10.09.48.12* State regulations shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 49 — Telehealth Services **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-105.2(b), Annotated Code of Maryland; Ch. 280, Acts of 2013; Ch. 366, Acts of 2016; Ch. 367, Acts of 2016 **Administrative History:** Effective date: September 30, 2013 (40:19 Md. R. 1546) **Administrative History:** Regulation .01 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .01A amended effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .02B amended effective April 28, 2014 (41:8 Md. R. 471); December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300); April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .03 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .04D amended effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .05 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .05B, D amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .06B amended effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .07 amended effective December 22, 2014 (41:25 Md. R. 1479); October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .07B amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471); October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .09 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .10A, B amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .11 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .11I, J adopted effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .12A, B amended effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .12 repealed and new Regulation .12 adopted effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Chapter revised effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .02B amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .04D amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .05 amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .06 amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .07C, D amended effective March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .07D amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .09 amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .10 amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .11 amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .11C, D amended effective February 27, 2017 (44:4 Md. R. 252) **Administrative History:** Chapter revised effective October 7, 2019 (46:20 Md. R. 844) **Administrative History:** Chapter revised effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .02B amended effective June 8, 2026 (53:11 Md. R. 485) **Administrative History:** Regulation .07B, F amended effective June 8, 2026 (53:11 Md. R. 485) **Administrative History:** Regulation .08B amended effective June 8, 2026 (53:11 Md. R. 485) #### Regulation .01 Scope. *COMAR 10.09.49.01* A. This chapter applies to covered services delivered via synchronous telehealth and eligible for reimbursement by the Maryland Medicaid Program. B. The purpose of providing medically necessary services via telehealth is to improve: (1) Access to services, thus reducing preventable hospitalizations and barriers to health care access; (2) Access to outpatient and inpatient subspecialty services, thus improving diagnostic clarification, treatment recommendations, and planning for the individual; (3) Health outcomes through timely disease detection and treatment options; and (4) Capacity and choice for ongoing treatment in underserved areas of the State. #### Regulation .02 Definitions. *COMAR 10.09.49.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative services organization (ASO)” means an entity that manages the Public Behavioral Health System on behalf of the Department. (2) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (3) “Distant site” means a site at which the licensed, certified, or otherwise authorized distant site provider is located at the time the service is provided via technology-assisted communication. (4) “Distant site provider” means the licensed, certified, or otherwise authorized provider at the distant site who provides medically necessary services via telehealth to the patient. (5) “GT modifier” means the Healthcare Common Procedure Coding System service code modifier indicating that the provider rendered a healthcare service via an interactive audio and video telecommunications system. (6) “Medically necessary" means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, family, or provider. (7) “Originating site means the location of an eligible Medicaid participant at the time the service being furnished via technology-assisted communication occurs. (8) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (9) “Provider” means: (a) An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Medical Assistance participants and who, through appropriate agreement with the Department, has been identified as a Maryland Medical Assistance Provider by the issuance of an individual account number; (b) An agent, employee, or related party of a person identified in §B(12)(a) of this regulation; (c) An individual or any other person with an ownership interest in a person identified in §B(12)(a) of this regulation. (10) Store and Forward Technology. (a) “Store and forward technology" means the transmission of medical images or other media captured by the originating site provider and sent electronically to a distant site provider, who does not physically interact with the patient located at the originating site. (b) “Store and forward technology” does not mean dermatology, ophthalmology, or radiology services according to COMAR 10.09.02.07. (11) “Technology-assisted communication” means multimedia communication equipment permitting two-way real-time interactive communication between a patient at an originating site and a distant site provider at a distant site. (12) “Telehealth” means the synchronous delivery of medically necessary services to a patient at an originating site by distant site provider, through the use of technology-assisted communication. (13) “Telehealth Program” means the program by which medically necessary services are authorized to be delivered via technology-assisted communication between originating and distant site providers. (14) “UB modifier” means the Healthcare Common Procedure Coding System service code modifier indicating that the provider rendered a healthcare service via an interactive audio-only telecommunications system. #### Regulation .03 Covered Services. *COMAR 10.09.49.03* Under the Telehealth Program, the Department shall cover: A. Medically necessary services covered by the Maryland Medical Assistance Program rendered via telehealth that shall be: (1) Distinct from services provided in person; (2) Able to be delivered using technology-assisted communication; and (3) Clinically appropriate to be delivered via telehealth; B. Services provided via telehealth to the same extent and standard of care as services provided in person; C. As determined by the provider’s licensure or credentialing board, services performed via telehealth within the scope of a provider’s practice; and D. Services permitted to be provided via telehealth as set forth in the COMAR chapter defining the covered service being rendered.. #### Regulation .04 Provider Conditions for Participation. *COMAR 10.09.49.04* A. To render or bill for services delivered via telehealth, the provider shall meet the requirements as set forth in: (1) COMAR 10.09.36.02; (2) COMAR 10.09.36.03; and (3) The COMAR chapter defining the covered service being rendered. B. The provider shall obtain the participant’s consent to services via telehealth, unless there is an emergency that prevents obtaining consent, which shall be documented in the participant’s medical record. C. Medical Record Documentation. The provider shall: (1) Maintain documentation in the same manner as during an in-person visit, using either electronic or paper medical records; (2) Retain telehealth records according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland; and (3) Include the participant's consent to participate in telehealth or an explanation as to why consent was not available. D. An originating site may be any secure location, approved by the participant and the provider, for the delivery of telehealth services. E. Distant Site Providers may render services via telehealth within the provider's scope of practice. #### Regulation .05 Technical Requirements. *COMAR 10.09.49.05* A. A provider of services delivered through telehealth shall adopt and implement technology in a manner that supports the standard of care to deliver the required service. B. A service delivered through synchronous audio-visual telehealth shall, at a minimum, meet the following technology requirements: (1) Cameras at both the originating and distant sites that provide clear, synchronous video of the patient and provider, respectively, with the ability to meet the clinical requirements of the service; (2) Unless engaging in a telehealth with a participant who is deaf or hard of hearing, microphones and speakers at both the originating and distant sites, respectively, that provide clear, synchronous, two-way audio transmission; (3) Network connectivity and bandwidth at both the originating and distant site sufficient to provide clear, synchronous two-way video and audio for the full duration of the service; (4) Display monitor size sufficient to support diagnostic needs used in the telehealth services; and (5) Utilize technology that meets the standards required by State and federal laws governing the privacy and security of protected health information (HIPAA compliant). #### Regulation .06 Confidentiality. *COMAR 10.09.49.06* The provider: A. Shall comply with all State and federal laws and regulations concerning the privacy and security of protected health information, including but not limited to: (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended; B. Shall ensure that all interactive video technology-assisted and audio-only communication comply with HIPAA patient privacy and security regulations throughout the transmission process; C. Shall occupy a space or area that meets the minimum standards for privacy expected for a patient-provider interaction; D. May not disseminate any participant images or information to other entities without the participant's consent, unless there is an emergency that prevents obtaining consent; and E. May not store the video images or audio portion of the service delivered via telehealth for future use. #### Regulation .07 Limitations. *COMAR 10.09.49.07* A. A service delivered via telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage that exist for services delivered in person. B. A service delivered via telehealth does not include: (1) An electronic mail message between a health care provider and a patient; (2) A facsimile transmission between a health care provider and a patient; or (3) A telephone conversation, electronic mail message, or facsimile transmission between providers without direct interaction with the patient. C. Store and forward technology does not meet the Maryland Medical Assistance Program's definition of telehealth. The Maryland Medical Assistance Program covers services such as dermatology, ophthalmology, and radiology according to COMAR 10.09.02.07. D. The provider may not bill the Maryland Medicaid Assistance Program for services delivered via telehealth when technical difficulties preclude the delivery of all or part of the telehealth session. E. The Department may not reimburse for services that: (1) Require in-person evaluation; or (2) Cannot be reasonably delivered via telehealth as specified in provider specific COMAR chapters, and subregulatory guidance issued by the Department. F. A provider may not bill for facility, room, or board charges for telehealth visits if a professional fee can be billed separately. #### Regulation .08 Reimbursements. *COMAR 10.09.49.08* A. To receive reimbursement for services delivered via telehealth, a provider shall: (1) Be actively enrolled with Maryland Medical Assistance on the date the service is rendered; and (2) Comply with payment procedures as set forth in COMAR 10.09.36. B. Distant Site Reimbursement. (1) The distant site provider shall be reimbursed as set forth in the COMAR chapter defining the covered service being rendered. (2) Services delivered via audio-visual telehealth shall be billed with the telehealth GT modifier. (3) Services delivered via audio-only telehealth shall be billed with the UB modifier. (4) Services delivered via telehealth shall be within the provider's scope of practice as determined by its governing licensure or credentialing board. #### Regulation .09 Limitations. *COMAR 10.09.49.09* A. A service provided through telehealth is subject to the same program restrictions, preauthorizations, limitations, and coverage that exist for the service when provided in person. B. A telehealth service does not include: (1) An audio-only telephone conversation between a health care provider and a patient; (2) An electronic mail message between a health care provider and a patient; (3) A facsimile transmission between a health care provider and a patient; or (4) A telephone conversation, electronic mail message, or facsimile transmission between the originating and distant site providers without interaction between the distant site provider and the patient. C. Store and forward technology does not meet the Maryland Medical Assistance Program’s definition of telehealth. The Maryland Medical Assistance Program covers services such as dermatology, ophthalmology, and radiology according to COMAR 10.09.02.07. D. Telehealth-delivered services may not bill to the Maryland Medical Assistance Program or to the ASO when technical difficulties preclude the delivery of part or all of the telehealth session. E. The Department may not reimburse a provider for the following: (1) Services that occur during an ambulance transport; (2) Communications between providers where the participant is not physically present at the originating site; (3) Telehealth services delivered where the originating site is not a permitted originating site provider as set forth in Regulation .06 of this chapter; or (4) Mental health and substance use disorder services that did not receive prior authorization from the Department or its ASO. F. The Department may not reimburse for services that: (1) Require in-person evaluation; or (2) Cannot be reasonably delivered via telehealth. G. The Department may not reimburse distant site providers for a facility fee. H. The Department may not reimburse for home health monitoring services. #### Regulation .10 Reimbursement. *COMAR 10.09.49.10* A. To receive reimbursement for telehealth services, a provider shall: (1) Be actively enrolled with Maryland Medical Assistance; (2) Participate with a telehealth partner that meets provider conditions for participation as set forth in Regulation .06 of this chapter; and (3) If a provider is a behavioral health service provider, be registered as a provider through the ASO on the date the service is rendered. B. Distant Site Reimbursement. (1) The distant site shall be reimbursed: (a) For somatic services provided via telehealth, as set forth in COMAR 10.09.02.07D; (b) For mental health services provided via telehealth, as set forth in COMAR 10.09.59.09; or (c) For substance use disorder services provided via telehealth, as set forth in COMAR 10.09.80.08. (2) Services delivered via telehealth shall be billed with the telehealth GT modifier. (3) Services delivered via telehealth shall be within the provider’s scope of practice as determined by its governing licensure or credentialing board. ### Chapter 50 — EPSDT School Health-Related Services or Health-Related Early Intervention Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-124, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective February 2, 1993 (20:4 Md. R. 369); adopted permanently effective June 1, 1993 (20:10 Md. R. 852) **Administrative History:** Regulations .01—.04 and .06 amended as an emergency provision effective September 19, 1997 (24:21 Md. R. 1445); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) **Administrative History:** Regulations .01, .02, .04, and .05 amended effective June 25, 2001 (28:12 Md. R. 1106) **Administrative History:** Regulations .01B, .02B, and .04—.06 amended as an emergency provision effective September 2, 1994 (21:20 Md. R. 1729); amended permanently effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .05B amended as an emergency provision effective July 1, 1996 (23:15 Md. R. 1083); amended permanently effective November 4, 1996 (23:22 Md. R. 1497) **Administrative History:** Chapter revised as an emergency provision effective December 17, 2002 (30:1 Md. R. 22); emergency status extended at 30:14 Md. R. 933; revised permanently effective August 4, 2003 (30:15 Md. R. 991) **Administrative History:** Regulation .01B amended effective March 14, 2016 (43:5 Md. R. 386); May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .02 amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .02B amended effective March 14, 2016 (43:5 Md. R. 386) **Administrative History:** Regulation .03 amended effective March 14, 2016 (43:5 Md. R. 386) **Administrative History:** Regulation .03A amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .04 amended effective March 14, 2016 (43:5 Md. R. 386) **Administrative History:** Regulation .04A, B amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .04C adopted effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .05 amended effective March 14, 2016 (43:5 Md. R. 386) **Administrative History:** Regulation .05C amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .06 amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .07B amended effective September 26, 2016 (43:19 Md. R. 1072); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .07E, F amended effective November 14, 2011 (38:23 Md. R. 1421) **Administrative History:** Regulation .07E amended effective March 14, 2016 (43:5 Md. R. 386); February 27, 2017 (44:4 Md. R. 252) **Administrative History:** Regulation .07F repealed effective March 14, 2016 (43:5 Md. R. 386) **Administrative History:** Regulation .07F adopted effective May 12, 2025 (52:9 Md. R. 405) #### Regulation .01 Definitions. *COMAR 10.09.50.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Audiological evaluation” means identification, evaluation, and treatment of auditory impairments necessary to develop and implement an IFSP or an IEP pursuant to COMAR 13A.13.01.03B and 13A.05.01.03B. (2) “Audiologist” means an individual licensed by the Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech Language Pathologists to practice audiology in Maryland. (3) “Audiology service” means treatment of auditory impairments necessary to develop and implement an IFSP or an IEP pursuant to COMAR 13A.13.01.03B and 13A.05.01.03B. (4) “Dietitian-Nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Maryland State Board of Dietetic Practice to practice dietetics in Maryland. (5) “Aversive technique” means the use of painful or noxious stimuli to the body, which is intrusive to the individual's physical, mental, or emotional well-being, used to terminate challenging or maladaptive behavior. (6) “Child's family” means those individuals with whom a participant resides, who are responsible for the participant, and who are the primary nurturing caregivers. (7) “Crisis intervention services” means the therapeutic response that provides immediate care or referral for an individual with an urgent mental health need. (8) “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. (9) “Early intervention services (EIS)” means services which are consistent with COMAR 13A.13.01.03B. (10) “Individualized education program (IEP)” means a written description of special education and related services developed by an IEP team to be implemented to meet the individual needs of a child pursuant to COMAR 13A.05.01.03B and 13A.05.01.09. (11) “IEP team” means a group convened and conducted by a provider to develop a participant’s IEP, which is composed of a child’s parent or parents, the child’s teacher, and relevant service providers as indicated in COMAR 13A.05.01.03B and 13A.05.01.07. (12) “Individualized Family Service Plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child’s family developed by an IFSP team pursuant to COMAR 13A.13.01.03B. (13) “IFSP team” means a group convened and conducted by a provider to develop a participant’s IFSP, which is composed of a child’s parent or parents, the child’s service coordinator, and relevant service providers as indicated in COMAR 13A.13.01.06. (14) “Infants and toddlers with disabilities” means children from birth to the beginning of the school year following the child’s 4th birthday who are eligible for early intervention services, as described in COMAR 13A.13.01.03B and documented by appropriate licensed personnel as defined in COMAR 13A.13.01.03B. (15) “Jurisdiction” means a state or the District of Columbia. (16) “Local School System (LSS)” means any of the 24 public school systems in Maryland responsible for providing public elementary or secondary education. (17) “Local lead agency” means the agency designated by the local governing authority in each county and Baltimore City to administer the interagency system of early intervention services under the direction of the State Department of Education in accordance with Education Article, §8-416, Annotated Code of Maryland. (18) “Maladaptive behavior” means behavior that is: (a) Harmful to oneself or others; (b) Developmentally inappropriate; and (c) Disruptive or dangerous. (19) “Maryland State Department of Education” has the meaning stated in COMAR 13A.01.03. (20) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (21) “Mental health professional” has the meaning stated in COMAR 10.21.17.02B. (22) “Nurse” means an individual who is licensed to practice as a registered nurse (RN) or licensed practical nurse (LPN) in the jurisdiction in which services are provided. (23) “Nursing care plan” means a plan developed by a registered nurse that identifies the patient’s diagnoses and needs, the goals to be achieved, and the interventions required to meet the patient’s medical condition as defined in COMAR 10.09.53.01B. (24) Nursing Services. (a) “Nursing services” means skilled nursing services performed by a licensed nurse for a participant, which are necessary for the participant to benefit from educational or early intervention services pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. (b) “Nursing services” includes an initial assessment. (c) “Nursing services” does not include: (i) Routine assessments of recipients whose medical condition is stable, unless the assessment leads to an intervention or change in the nursing care plan; (ii) Administration of medications; (iii) Supervision of interventions which the child is able to perform independently; (iv) Health screens; (v) Health education, except one-on-one training regarding self-management of the child's medical condition; (vi) First aid interventions; (vii) Services not directly related to the nursing care plan; and (viii) Services not deemed medically necessary at the initial assessment or the most recent nursing care plan review. (25) Nutrition Services. (a) “Nutrition services” means services delivered by a licensed dietitian nutritionist. (b) “Nutrition services” includes: (i) Nutrition assessments and evaluations; (ii) Developing and monitoring appropriate plans to address the nutritional needs of eligible children; and (iii) Making referrals to appropriate community resources to carry out nutrition goals in an IFSP pursuant to COMAR 13A.13.01.03B. (26) “Occupational therapist” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice occupational therapy in Maryland. (27) “Occupational therapy assistant” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice limited occupational therapy in Maryland. (28) “Occupational therapy services” means occupational therapy evaluations or treatments delivered by a licensed occupational therapist, or treatments delivered by a licensed occupational therapy assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. (29) “Parent” means the parent of a child and includes: (a) A biological or adoptive parent; (b) A legal guardian; (c) Another person responsible for a child's welfare; or (d) A parent surrogate for those cases when: (i) A public agency, after reasonable efforts, cannot discover the whereabouts of a biological or adoptive parent, (ii) An individual cannot be identified with responsibility for a child's welfare, or (iii) A child is a ward of the State. (30) “Participant” means a Medical Assistance recipient who is eligible for and receives school-based health-related services. (31) “Physical therapist” means an individual licensed by the Maryland Board of Physical Therapy Examiners to practice physical therapy in Maryland. (32) “Physical therapist assistant” means an individual licensed by the Maryland Board of Physical Therapy Examiners to practice limited physical therapy in Maryland. (33) “Physical therapy services” means physical therapy evaluations or treatments, delivered by a licensed physical therapist, or treatments delivered by a licensed physical therapy assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. (34) “Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (35) “Provider” means a local school system, local lead agency, State-operated education agency, or State-supported education agency which meets the conditions for participation as defined in Regulation .03 of this chapter to provide school-based health-related services. (36) “Psychological services” means the delivery of services by a qualified licensed mental health professional, including administering psychological and developmental tests and other assessment procedures, interpreting assessment results, obtaining, integrating, and interpreting information about child behavior and child and family conditions related to learning, mental health, and development, and planning and managing a program of psychological services including psychological counseling for children and families. (37) “Rehabilitative service” means the medical or remedial service recommended by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland within the scope of the practice under §B(36) of this regulation, for the reduction of maladaptive behavior and restoration of a recipient to the best possible functional level. (38) “School psychologist” means an individual certified by the Maryland State Department of Education to provide psychological services in a school-based setting. (39) “Special health needs” means those temporary or long-term health problems arising from physical, emotional, or social factors, or any combination of these. (40) “Speech-language pathologist” means an individual licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice speech language pathology in Maryland. (41) “Speech-language pathology assistant” means an individual licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to assist in the practice of speech language pathology in Maryland. (42) “Speech-language pathology” means speech language evaluations, diagnoses or treatments delivered by a licensed speech-language pathologist, or treatments delivered by a licensed speech-language pathology assistant, which are necessary to develop and implement an IEP or an IFSP pursuant to COMAR 13A.05.01.03B and 13A.13.01.03B. (43) “Therapeutic behavioral aide” means an individual who has been trained to implement a behavior plan as specified in the IEP or IFSP under the supervision of a licensed physician or authorized practitioner pursuant to Health Occupations Article, Annotated Code of Maryland. (44) “Therapeutic behavioral service” means a one-to-one individualized rehabilitative service, rendered by a therapeutic behavioral aide, using appropriate methods of preventing or decreasing maladaptive behaviors for a Medicaid recipient who is eligible for and receives health-related services in an IEP or health-related early intervention services in an IFSP. #### Regulation .02 Licensure and Certification. *COMAR 10.09.50.02* A. A provider shall ensure that the provider's employees who render school health-related services meet the licensure or certification requirements for their profession, as specified in §B of this regulation. B. A professional employed by a provider shall have the following qualifications: (1) An audiologist shall be licensed to practice in the jurisdiction in which services are provided; (2) A professional counselor shall be licensed to practice in accordance with Health Occupations Article, Title 17, Annotated Code of Maryland, in the jurisdiction in which services are provided; (3) A nurse shall be a registered nurse or a practical nurse licensed to practice in the jurisdiction in which services are provided: (4) A nurse psychotherapist shall be licensed to practice in the jurisdiction in which services are provided; (5) A dietitian-nutritionist shall be licensed to practice in the jurisdiction in which services are provided; (6) An occupational therapist shall be licensed to practice in the jurisdiction in which services are provided; (7) An occupational therapy assistant shall be licensed to practice in the jurisdiction in which services are provided under the direction of a licensed occupational therapist; (8) A physical therapist shall be licensed to practice in the jurisdiction in which services are provided; (9) A physical therapy assistant shall be licensed to practice in the jurisdiction in which services are provided under the direction of a licensed physical therapist; (10) A psychiatrist shall be a physician licensed to practice in the jurisdiction in which services are provided who is certified by the American Board of Psychiatry and Neurology or who has completed the minimum educational and training requirements to take the Board examination; (11) A psychologist shall be licensed to practice in the jurisdiction in which services are provided; (12) A school psychologist shall be certified in accordance with COMAR 13A.12.04.09 to practice in the jurisdiction in which services are provided; (13) A social worker shall be licensed as: (a) A master social worker in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided; (b) A certified social worker in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided; or (c) A certified social worker-clinical in accordance with COMAR 10.42.01.04 to practice in the jurisdiction in which services are provided; (14) A speech language pathologist shall be licensed to practice in the jurisdiction in which services are provided; (15) A speech language pathology assistant shall be licensed to practice in the jurisdiction in which services are provided under the supervision of a licensed speech language pathologist; and (16) A therapeutic behavioral provider shall be approved by the Department in accordance with COMAR 10.09.50.05A. #### Regulation .03 Conditions for Participation. *COMAR 10.09.50.03* A. General requirements for participation in EPSDT school health-related or health-related early intervention services are that a: (1) Provider shall: (a) Meet all the requirements for participation in the Program as set forth in COMAR 10.09.36.03; and (b) Collaborate in the provision of covered services with local health departments in accordance with Education Article, §7-401, Annotated Code of Maryland; and (2) Therapeutic behavioral aide shall be: (a) Trained in the principles of behavioral management and appropriate methods of preventing or decreasing maladaptive behaviors relevant to the recipient's behavioral needs; and (b) Supervised by a licensed physician or an authorized practitioner under Health Occupations Article, Annotated Code of Maryland. B. Specific requirements for participation in the Program require that the provider maintain adequate documentation of all services provided, which at a minimum, includes: (1) The location, date, start, and end time of the service; (2) A brief description of the service; and (3) A legible signature, along with the printed or typed name of the individual providing care, with the appropriate title. #### Regulation .04 Covered Services. *COMAR 10.09.50.04* A. The Program covers the services listed in §B and C of this regulation when the services are: (1) Necessary to identify the need for a health-related service or health-related early intervention service; (2) Necessary to: (a) Prevent disease, disability, and other health conditions or their progression; and (b) Promote physical and mental health and efficiency; (3) Necessary for the maximum reduction of physical or mental disability and restoration of a participant to the participant's best possible functional level; and; (4) Rendered in accordance with accepted professional standards. B. The following services are covered under this chapter when delivered in accordance with an IEP or an IFSP, which is developed at the time of referral for health-related services or health-related early intervention services: (1) Audiology services, which include the identification, evaluation, and treatment of auditory impairments; (2) Nursing services, which: (a) Are related to an identified health problem; (b) Except for nursing assessments, are ordered by a licensed prescriber; (c) Are indicated in the nursing care plan, which is reviewed at least every 60 days and more frequently when the child's medical condition changes; and (d) Require the judgment, knowledge, and skills of a licensed nurse; (3) Nutrition services which include conducting assessments of nutritional history and dietary intake and developing and monitoring appropriate plans to address a participant’s nutritional needs; (4) Occupational therapy services, which include any screening, evaluations, or treatments necessary to implement a program of activities, with the goal to develop or maintain the adaptive skills necessary to achieve a participant’s adequate and appropriate physical and mental functioning; (5) Physical therapy services, which include screening and evaluations necessary to determine a participant’s level of functioning, as well as any treatment, which may use therapeutic exercises for the purpose of preventing, restoring, or alleviating a movement dysfunction and related functional problems; (6) Psychological services, which include the evaluation, diagnosis, and treatment of emotional or behavioral problems in order for a participant to benefit from an educational or early intervention program including the counseling of parents and parent training when the participant is present; (7) Speech-language pathology services, which include, diagnosis, evaluation, or treatment; and (8) Therapeutic behavioral services which: (a) Includes one-to-one services by a trained therapeutic behavior aide; and (b) Is supervised by a licensed physician or authorized practitioner under Health Occupations Article, Annotated Code of Maryland. C. Psychological services, as described in §B(6) of this regulation, are covered under this chapter even if the services are not delivered in accordance with an IEP or an IFSP. #### Regulation .05 Limitations. *COMAR 10.09.50.05* A. To participate in the Program as a provider of health-related services or health-related early intervention services, the provider shall be a local school system, a local lead agency, a State-operated education agency, or State-supported education agency. B. Health-related services or health-related early intervention services outlined in the IEP or the IFSP shall be approved by the IEP or IFSP team for continued treatment. C. Therapeutic behavioral services may only be provided if: (1) Preauthorized through the IEP or IFSP process and directly related to the IEP or IFSP; (2) Services are not custodial; (3) Services are considered medically necessary by the IEP or IFSP team, which develops the recipient’s IEP or IFSP; (4) Delivered in the recipient's home, school, or other setting if normal activities are disrupted; (5) The therapeutic behavioral aide is not a member of the recipient's immediate family or an individual who ordinarily resides in the recipient's home; and (6) The recipient has: (a) Maladaptive behavior; (b) Warrants a behavioral plan; (c) Behavior that is deviant from developmentally appropriate behavior for the individual’s chronological age as determined by the IEP or IFSP team; (d) A behavior plan that does not include aversive techniques, restraints, and seclusion, or any of these; and (e) No insurance coverage for therapeutic behavior services when compensated as an individual service covered by another third party insurance or part of a package of benefits covered by either another third party insurance or another public agency. #### Regulation .06 Preauthorization. *COMAR 10.09.50.06* A. Therapeutic behavioral services shall be preauthorized through the IEP or IFSP process. B. Psychological services that are not delivered in accordance with an IEP or IFSP shall be preauthorized by the Administrative Services Organization in accordance with COMAR 10.09.59.08. #### Regulation .07 Payment Procedures. *COMAR 10.09.50.07* A. Request for Payment. (1) An approved provider shall submit a request for payment of services rendered and completed under this chapter as set forth in COMAR 10.09.36.04. The Department reserves the right to return to the provider, before payment, all payment requests not properly prepared or submitted. (2) A provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. The completed form shall indicate the: (a) Date or dates of service; (b) Participant's name and Medical Assistance number; (c) Provider's name, location, and provider number; and (d) Nature, unit or units, and procedure code or codes of covered services provided. B. Providers may not bill the Program for: (1) Services not rendered in person, unless the services are provided in compliance with COMAR 10.09.49 and any guidance issued by the Department: (2) Completion of forms or reports; (3) Broken or missed appointments; (4) Services which duplicate a service that a recipient is receiving under another medical care program. C. The Program may not make direct payment to a participant. D. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. E. Reimbursement for health-related services and health-related early intervention services is contained in COMAR 10.09.02.07D. The State portion of reimbursement is provided by the Maryland State Department of Education. F. Psychological services not delivered in accordance with an IEP or IFSP are reimbursable when they are: (1) Rendered by a school psychologist or school social worker that: (a) Meets the qualifications of this chapter; and (b) Is enrolled with the Medicaid Program in accordance with COMAR 10.09.36; and (2) Billed by a local education agency in accordance with COMAR 10.09.59.09. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.50.08* Recovery and reimbursement is as set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.50.09* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.50.10* Appeal procedures are set forth in COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.50.11* Interpretive regulations are set forth in COMAR 10.09.36.10. ### Chapter 51 — Audiology Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: August 16, 1993 (20:16 Md. R. 1277) **Administrative History:** Chapter revised effective June 21, 2004 (31:12 Md. R. 911) **Administrative History:** Regulation .01B amended effective July 18, 2005 (32:14 Md. R. 1275); January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .02A amended effective January 16, 2006 (33:1 Md. R. 36); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .04 amended effective April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .04A amended effective January 16, 2006 (33:1 Md. R. 36) **Administrative History:** Regulation .05 amended effective July 18, 2005 (32:14 Md. R. 1275); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .05A amended effective December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .05B amended effective January 16, 2006 (33:1 Md. R. 36) **Administrative History:** Regulation .06 amended effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .06A amended effective July 18, 2005 (32:14 Md. R. 1275) **Administrative History:** Regulation .06B, C amended effective January 16, 2006 (33:1 Md. R. 36) **Administrative History:** Regulation .06B, D amended effective April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .07 amended effective January 16, 2006 (33:1 Md. R. 36); April 4, 2011 (38:7 Md. R. 431); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .07B amended effective April 21, 2008 (35:8 Md. R. 805); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .07C, G, K amended effective July 4, 2016 (43:13 Md. R. 712) #### Regulation .01 Definitions. *COMAR 10.09.51.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Audiologist” means a professional who is licensed in accordance with Regulation .02 of this chapter who treats hearing disorders and communication problems. (2) “Audiology assessment” means procedures performed by an audiologist to evaluate and monitor the status of the peripheral auditory system, auditory nerve, and central auditory system, or to establish the site of the auditory disorder by using procedures to quantify and qualify hearing loss by site of lesion, on the basis of perceptual, physiological, or electrophysiological responses to acoustic stimuli, and to describe any communicative disorders. (3) Audiology Center. (a) “Audiology center” means a multispecialty setting with all necessary equipment for audiology services that operates for the purpose of providing preventive, diagnostic, therapeutic, and rehabilitative audiology services, and other multispecialty services by or under the direction of a licensed physician or audiologist. (b) “Audiology center” does not include the office of one or more private audiologists. (4) “Audiology services” means services delivered by an audiologist to eligible participants in order to diagnose and treat hearing problems. (5) “Auditory osseointegrated device” means a device implanted in the skull that replaces the function of the middle ear and provides mechanical energy to the cochlea via a mechanical transducer. (6) “Bilateral” means relating to or involving both ears. (7) “Cochlear implant” means a device that is implanted under the skin that picks up sounds and converts them to impulses transmitted to electrodes placed in the cochlea, restoring some hearing to people with a hearing impairment. (8) “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (9) “Designee” means any entity designated to act on behalf of the Department. (10) “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision of preventive health care under 42 CFR §441.50 et seq., including medical and dental services, in order to assess growth and development and to detect and treat health problems in Medical Assistance eligible individuals under 21 years old. (11) “EPSDT screening provider” means a physician, audiologist, or an authorized practitioner under Health Occupations Article, Annotated Code of Maryland. (12) “Hearing aid” means an instrument or device that is designed for improving or correcting impaired human hearing, or any part or accessory of the instrument or device. (13) “Hearing aid dispenser” means a person who is licensed in accordance with Regulation .02 of this chapter to sell hearing aids or provide other hearing aid services. (14) “Hearing aid evaluation” means services provided to a participant by an audiologist for determining the benefit of hearing aids and, upon the audiologist’s recommendation, the dispensing of hearing aids. (15) “Maryland Medical Assistance Program (Program)” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. (16) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (17) “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. (18) “Program” has the meaning stated in COMAR 10.09.36.01. (19) “Provider” means an audiologist, audiology center, or hearing aid dispenser that is licensed and that, through an agreement with the Department, has been identified as a Program provider by the issuance of a provider number. (20) “Unilateral” means relating to, involving, or affecting one ear. #### Regulation .02 Licensure Requirements. *COMAR 10.09.51.02* A. In order to provide services as an audiologist under this chapter, an audiologist shall be licensed by the State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice audiology, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland, or by the appropriate licensing body in the jurisdiction in which the audiology services are performed. B. In order to provide services as a hearing aid dispenser under this chapter, a hearing aid dispenser shall be licensed by the: (1) State Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to dispense hearing aids and hearing aid accessories, as defined in Health Occupations Article, Title 2, Annotated Code of Maryland; or (2) Appropriate licensing body in the jurisdiction in which the hearing aids are dispensed. #### Regulation .03 Conditions for Participation. *COMAR 10.09.51.03* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. Specific requirements for participation in the Program as an audiologist, audiology center or group, or hearing aid dispenser are that the provider: (1) Shall meet the licensure requirements in accordance with Regulation .02 of this chapter; and (2) May not knowingly employ another person to provide services to Maryland Medical Assistance Program participants after that person has been disqualified from the Program unless prior approval has been received from the Department. #### Regulation .04 Covered Services. *COMAR 10.09.51.04* The Program covers the following medically necessary services: A. Audiology services, as follows: (1) For participants who are at risk for or have a hearing impairment, audiology assessments using procedures appropriate for the participant’s developmental age and abilities; and (2) Hearing aid evaluations and routine follow-up for participants with an identified hearing impairment, who currently use or are being considered for hearing aids; and B. Hearing amplification services, as follows: (1) Unilateral or bilateral hearing aids which are medically necessary and are: (a) Not used or rebuilt, and which meet the current standards set forth in 21 CFR §§801.420 and 801.421, which are incorporated by reference; (b) Recommended and fitted by an audiologist in conjunction with written medical clearance from a physician who has performed a medical examination within the past 6 months; (c) Sold on a 30-day trial basis; and (d) Fully covered by a manufacturer’s warranty for a minimum of 2 years, at no cost to the Program; (2) Hearing aid accessories and services, as listed below: (a) Ear molds; (b) Batteries; (c) Routine follow-ups and adjustments; (d) Repairs after all warranties have expired; (e) Replacement of unilateral or bilateral hearing aids every 5 years when determined to be medically necessary; and (f) Other hearing aid accessories determined to be medically necessary; (3) Cochlear implants and related services, as listed below: (a) Unilateral or bilateral implantation of cochlear implant or implants which are medically necessary including the cost of the device; (b) Post-operative evaluation and programming of the cochlear implant or implants; (c) Aural rehabilitation services; and (d) Repair or replacement of cochlear implant device components subject to the limitations in Regulation .05 of this chapter; and (4) Auditory osseointegrated device or devices and related services, as listed below: (a) Unilateral or bilateral implantation of auditory osseointegrated devices which are medically necessary including the cost of the device; (b) Non-implantable or softband device or devices which are medically necessary; (c) Evaluation and programming of the auditory osseointegrated device or devices; and (d) Repair or replacement, or both, of auditory osseointegrated device components subject to the limitations in Regulation .05 of this chapter. #### Regulation .05 Limitations. *COMAR 10.09.51.05* A. Covered audiology services, including hearing aids, cochlear implants, and auditory osseointegrated devices are limited to: (1) Unless the time limitation is waived by the Program, one audiology assessment per year; (2) The initial coverage of unilateral or bilateral hearing aids, cochlear implants, or auditory osseointegrated devices when the Department’s medical necessity criteria have been met; (3) One replacement of unilateral or bilateral hearing aids: (a) Every 5 years for participants younger than 21 years old, unless the Program approves more frequent replacement; or (b) Every 5 years for participants 21 years old or older, unless the Program approves more frequent replacement, but no more than 1 replacement extraneous to the devices’ warranty; (4) Replacement of hearing aids, cochlear implants and auditory osseointegrated device components that have been lost, stolen, or damaged beyond repair, after all warranties have expired; (5) Repairs and replacements that take place after all warranties have expired; (6) A maximum of 76 batteries per participant per 12-month period for a unilateral hearing aid or osseointegrated devices, or 152 batteries per participant per 12-month period for bilateral hearing aids or osseointegrated devices purchased from the Department not more frequently than every 6 months, and in quantities of 38 or fewer for a unilateral hearing aid, or 76 or fewer for a bilateral hearing aid; (7) A maximum of 238 disposable batteries for a unilateral cochlear implant per participant per 12-month period or 476 disposable batteries per 12-month period for a bilateral cochlear implant purchased not more frequently than every 6 months, and in quantities of 119 or fewer for a unilateral cochlear implant, or 238 or fewer for a bilateral cochlear implant; (8) Four replacement cochlear implant component rechargeable batteries per 12-month period for bilateral cochlear implants, and a maximum of two replacement rechargeable batteries for a unilateral cochlear implant per 12-month period; (9) Two cochlear implant replacement transmitter cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitter cable for a unilateral cochlear implant per 12-month period; (10) Two cochlear implant replacement headset cables per 12-month period for bilateral cochlear implants, and a maximum of one replacement headset cable for a unilateral cochlear implant per 12-month period; (11) Two replacement cochlear implant transmitting coils per 12-month period for bilateral cochlear implants, and a maximum of one replacement transmitting coil for a unilateral cochlear implant per 12-month period; (12) Charges for routine follow-ups and adjustments which occur more than 60 days after the dispensing of a new hearing aid; and (13) A maximum of two unilateral earmolds or four bilateral earmolds per 12-month period unless a larger number is determined to be medically necessary. B. Services which are not covered are: (1) Services not medically necessary; (2) Hearing aids and accessories not medically necessary; (3) Cochlear implant services and external components not medically necessary; (4) Cochlear implant services and external components provided less than 90 days after the surgery which are covered through the initial reimbursement; (5) Spare or backup cochlear implant components; (6) Spare or back-up auditory osseointegrated device components; (7) Replacement of hearing aids, equipment, cochlear implant components, and auditory osseointegrated device components if the existing devices are functional, repairable, and appropriately correct or ameliorate the problem or condition; (8) Spare or backup hearing aids, equipment, or supplies; (9) Repairs to spare or backup hearing aids, cochlear implants, auditory osseointegrated devices, equipment, or supplies; (10) Investigational or experimental services or devices, or both; (11) Replacement of improperly fitted earmold or earmolds unless the: (a) Replacement service is administered by someone other than the original provider; and (b) Replacement service has not been claimed before; (12) Additional professional fees and overhead charges for a new hearing aid when a dispensing fee claim has been made to the Program; and (13) Loaner hearing aids. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.51.06* A. The Department requires preauthorization for the following services: (1) All hearing aids; (2) Certain hearing aid accessories; (3) All cochlear implant devices and replacement components except microphone, transmitter cables, and transmitting coils; (4) All auditory osseointegrated devices; and (5) Repairs for hearing aids, cochlear implants, and auditory osseointegrated components exceeding $500. B. Preauthorization is valid: (1) For services rendered or initiated within 6 months from the date the preauthorization was issued; and (2) If the patient is an eligible participant at the time the service is rendered. C. The following written documentation shall be submitted by the provider to the Department or its designee with each request or preauthorization of hearing aids, cochlear implants, or auditory osseointegrated devices: (1) Audiology report documenting medical necessity of the hearing aids, cochlear implants or auditory osseointegrated devices; (2) Interpretation of the audiogram; and (3) Medical evaluation by a physician supporting the medical necessity of the initial hearing aids, cochlear implants, or auditory osseointegrated devices within 6 months of the preauthorization request. #### Regulation .07 Payment Procedures. *COMAR 10.09.51.07* A. To obtain compensation from the Department for covered services, the provider shall submit a request for payment using the format designated by the Department. B. Audiology services are reimbursed in accordance with COMAR 10.09.23.01-1. C. The provider shall be paid the lesser of: (1) The provider’s customary charge to the general public, unless the service is free to individuals not covered by Medicaid; or (2) The rate in accordance with the Department’s fee schedule. D. The provider may not bill the Department or participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; or (3) Professional services rendered by mail or telephone. E. Audiology centers licensed as a part of a hospital may charge for and be reimbursed according to rates approved by the Health Services Cost Review Commission (HSCRC), set forth in COMAR 10.37.03. F. The provider shall refund to the Department payment for hearing aids, supplies, or both, that have been returned to the manufacturer within the 30-day trial period. G. The provider shall give the Department the full advantage of any and all manufacturer’s warranties and trade-ins offered on hearing aids, equipment, or both. H. Unless preauthorization has been granted by the Department or its designee, the Department is not responsible for any reimbursement to a provider for any service provided which requires preauthorization. I. The Department may not make direct payment to participants. J. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.51.08* Recovery and reimbursement requirements are as set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.51.09* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.51.10* Appeal procedures are as set forth in COMAR 10.09.36.09. #### Regulation .11 Interpretation of State Regulations. *COMAR 10.09.51.11* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 52 — Service Coordination for Children with an IEP or Enrolled in the Autism Waiver **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective June 17, 1993 (20:14 Md. R. 1165); adopted permanently effective September 27, 1993 (20:19 Md. R. 1472) **Administrative History:** Regulations .01—.06 amended as an emergency provision effective March 23, 1998 (25:8 Md. R. 595); amended permanently effective June 29, 1998 (25:13 Md. R. 993): **Administrative History:** Regulations .01—.06 amended effective July 1, 2001(28:12 Md. R. 1107) **Administrative History:** Regulation .01B amended effective August 27, 2007 (34:17 Md. R. 1507); March 28, 2016 (43:6 Md. R. 407): November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .02 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 407) **Administrative History:** Regulation .03 amended as an emergency provision effective July 1, 2002 (30:1 Md. R. 23); amended permanently effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .03 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .03B amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .03B, C amended effective March 28, 2016 (43:6 Md. R. 407) **Administrative History:** Regulation .03-1 adopted effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 407); November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulations .04-1 and .04-2 adopted effective July 1, 2001(28:12 Md. R. 1107) **Administrative History:** Regulations .04-1 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04-1D amended effective March 28, 2016 (43:6 Md. R. 407) **Administrative History:** Regulation .04-2 amended effective March 28, 2016 (43:6 Md. R. 407); November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04-2C amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 407) **Administrative History:** Regulation .06A, C amended effective November 13, 2023 (50:22 Md. R. 973) #### Regulation .01 Definitions. *COMAR 10.09.52.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Autism” has the meaning stated in COMAR 10.09.56.01C. (2) “Autism Waiver” or “Waiver” means the Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder. (3) “Autism Waiver Service Coordination” means the coordination of waiver services covered under this chapter. (4) “Autism Waiver Service Coordinator” means an individual who meets the requirements specified in Regulation .03-1 of this chapter and provides the autism waiver services specified in Regulations .04-1—04.2 of this chapter to a waiver participant. (5) “Department” has the meaning stated in COMAR 10.09.36.01. (6) “Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder” means the program implemented under COMAR 10.09.56 in accordance with the document and any amendments to it submitted by the Department to, and approved by, the Secretary of the U. S. Department of Health and Human Services, which authorizes the waiver, pursuant to Section 1915(c) of Title XIX of the Social Security Act, of certain specified statutory requirements limiting coverage for home and community-based services under the Medical Assistance Program. (7) “IEP service coordination” means the coordination of services which assists a participant in gaining access to the services recommended in the participant’s IEP. (8) “IEP service coordinator” means an individual who meets the requirements in Regulation .03C of this chapter. (9) “Individualized Education Program (IEP)” means a written, individualized plan of care for a participant, that: (a) Is developed by an IEP team on a form approved by MSDE; (b) Recommends the special education and related services to meet a participant's needs; and (c) Conforms with the requirements in COMAR 13A.05.01 and 34 CFR §§300.320—300-324. (10) “Individualized education program (IEP) team” means the multidisciplinary team convened by a provider in accordance with COMAR 13A.05.01 to review a participant’s needs, develop the participant’s IEP, and determine the placement of the participant in the least restrictive environment. (11) “Individualized family service plan (IFSP)” means a written, individualized plan for providing early intervention and other services for an infant, toddler, or preschool-age child, in accordance with COMAR 13A.13.01. (12) “Local lead agency” means the agency designated by the local governing authority in each jurisdiction to administer the interagency system of early intervention services under the direction of the Maryland State Department of Education. (13) “Local school system (LSS)” means any public school system in Maryland responsible for providing public elementary or secondary education. (14) “Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.67.01.01. (15) “Maryland State Department of Education (MSDE)” is the agency responsible for ensuring that all children with disabilities residing in the State are identified, assessed, and provided with a free, appropriate public education consistent with State and federal laws. (16) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (17) “Parent” has the meaning stated in COMAR 13A.13.01.03. (18) “Participant” means an individual who meets the qualifications for participation in the services covered under this chapter, as specified in Regulation .02 of this chapter. (19) “Program” has the meaning stated in COMAR 10.09.36.01. (20) “Provider” means an agency which meets the conditions for participation, as specified in Regulation .03 of this chapter. (21) “Qualified diagnostician” means an individual whose license or certification permits diagnosis of Autism Spectrum Disorder. (22) “Rare and expensive case management (REM)” has the meaning stated in COMAR 10.09.69.02. (23) “Telehealth” has the meaning as stated in COMAR 10.09.49.02. (24) “Waiver eligible person” means an individual who meets the qualifications, as specified in COMAR 10.09.56, for participation in the Autism Waiver. (25) “Waiver multidisciplinary team” means the team, consistent with the Individuals with Disabilities Education Act (IDEA), which is convened for a waiver applicant or waiver participant. (26) “Waiver participant” means a waiver eligible person who is enrolled in the Autism Waiver. (27) “Waiver plan of care” means the written, individualized treatment plan which preauthorizes the specific Autism Waiver services to be provided to a waiver participant, as covered under COMAR 10.09.56. #### Regulation .02 Participant Eligibility. *COMAR 10.09.52.02* A participant is eligible for Service Coordination if: A. The individual is enrolled as a waiver participant in accordance with the requirements of COMAR 10.09.56 and this chapter; or B. The following requirements are met: (1) The participant, for whom free and appropriate education is provided under the Individuals with Disabilities Education Act, is aged 3 through 20 years old; (2) An IEP team determines that the participant is a child with disabilities who: (a) Is eligible for special education and related services, and (b) Needs an IEP; (3) The participant elects, or the participant’s parent elects on the participant’s behalf, to receive the services available under this chapter; and (4) The participant is not a resident of any of the facilities that receive Medicaid reimbursement for residential services. #### Regulation .03 Conditions for Participation for IEP Service Coordination Providers. *COMAR 10.09.52.03* A. General requirements for participation in the Program are that a provider shall: (1) Meet all the conditions for participation as set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. IEP service coordination providers shall: (1) Be an agency within the State that: (a) Operates programs with special education and related services for children with disabilities, in accordance with COMAR 13A.05.01; and (b) Is eligible to receive, through MSDE, funding from Assistance to States for the Education of Children with Disabilities under Part B of the Individuals with Disabilities Education Act; (2) Convene or participate on an IEP team or teams, in accordance with COMAR 13A.05.01; (3) Designate specific, qualified individuals as service coordinators, and verify their credentials for providing the services covered under this chapter; (4) Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs which are applicable to participants; (5) Maintain a file on each participant which meets the Program’s requirements which shall include: (a) Copies of the participant's IEP with any revisions; (b) Written parental consent to initiate services covered under this chapter; (c) Written parental consent prior to accessing the student’s public benefits or insurance the first time, and annually thereafter, in accordance with 34 CFR §300.154(d)(2); (d) Approval from a participant’s parent of the participant’s IEP before implementation of the IEP service coordination; and (e) A record of IEP service coordination encounters including: (i) A brief description of the service; (ii) The location; (iii) The name of the contact (parent/guardian or student); (iv) The date of the service; and (v) The IEP service coordinator’s printed name and signature; and (6) Employ or have under contract qualified personnel who convene or participate on IEP teams, convene or participate on multidisciplinary teams as necessary, and develop participants’ IEPs. C. IEP Service Coordinator Requirements. (1) An IEP service coordinator shall: (a) Be employed by or under contract with a provider; (b) Be identified by the IEP team ; (c) Participate with the IEP team in the development or revision of a participant’s IEP and in the IEP review; (d) Assist the participant in gaining access to the services recommended in the IEP; and (e) Collect and synthesize evaluation reports and other relevant information about a participant that might be needed by an IEP team. (2) An IEP service coordinator shall have the following qualifications and be a: (a) Professional who has a current license or certification, in accordance with §C(3) of this regulation, in the profession most immediately relevant to a participant's needs; or (b) Nonprofessional who meets the requirements in §C(4) of this regulation. (3) A professional who is chosen as a participant's service coordinator shall meet the following licensing or certification requirements, as appropriate, and be: (a) An audiologist licensed pursuant to COMAR 10.41.03.03 and certified pursuant to COMAR 13A.12.03.09; (b) A guidance counselor with at least a master's degree and certified pursuant to COMAR 13A.12.03.02; (c) A professional counselor licensed to practice in accordance with Health Occupations Article, Title 17, Annotated Code of Maryland; (d) A registered nurse licensed pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; (e) An occupational therapist licensed pursuant to Health Occupations Article, Title 10, Annotated Code of Maryland; (f) A physical therapist licensed pursuant to Health Occupations Article, Title 13, Annotated Code of Maryland; (g) A psychologist with at least a master's degree in psychology and certified pursuant to COMAR 13A.12.03.08; (h) A pupil personnel worker with at least a master's degree and certified pursuant to COMAR 13A.12.03.04; (i) A social worker licensed at the master's level as a licensed certified social worker or licensed graduate social worker, pursuant to Health Occupations Article, Title 19, Annotated Code of Maryland; (j) A speech-language pathologist: (i) With at least a master's degree in speech pathology; or (ii) Certified pursuant to COMAR 13A.12.03.09 or licensed pursuant to Health Occupations Article, Title 2, Annotated Code of Maryland; (k) An education professional who is: (i) Certified as a teacher pursuant to COMAR 13A.12.02; or (ii) Certified as an administrator or supervisor pursuant to COMAR 13A.12.04. (4) A nonprofessional who is chosen as a participant’s IEP service coordinator shall meet the following requirements: (a) Have at least a high school diploma or the equivalent; (b) Have demonstrated training or experience in providing IEP service coordination to students with disabilities; and (c) Participate in ongoing IEP service coordination training offerings as specified in the interagency plan for special education services. #### Regulation .03-1 Conditions for Participation for Autism Waiver Service Coordination Providers. *COMAR 10.09.52.03-1* A. General requirements for participation in the Program are that a provider shall: (1) Meet all the conditions for participation as set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. Specific requirements for participation in the Program as a provider of Autism Waiver Service Coordination are that a provider shall: (1) Be an agency within the State that employs or has under contract qualified personnel who convene or participate on waiver multidisciplinary teams as necessary, develop participant’s waiver plans of care, and provide service coordination services for waiver participants; (2) Designate specific, qualified individuals as Autism Wavier service coordinators and verify their credentials for providing the services covered under this chapter; (3) Convene or participate on a waiver multidisciplinary team or teams for waiver participants, in accordance with the requirements of COMAR 10.09.56 and this chapter; (4) Be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs that are applicable to participants; and (5) Maintain a file on each participant that meets the Program’s requirements and includes the waiver participant’s: (a) Technical eligibility form approved by MSDE, reviewed and signed at least annually; (b) Determination of eligibility for level of care in an intermediate care facility for the intellectually disabled and persons with related conditions (ICF/IID) — initial determination and redetermination, at least annually; (c) Autism Waiver Risk Assessment pursuant to 10.09.56; (d) Consent Form for Autism Waiver Services, signed before Autism Waiver enrollment and annually thereafter; (e) Form for determination of Medicaid eligibility for Autism Waiver services — initial determination and redetermination, at least annually; (f) Initial waiver plan of care, reviewed at least annually, and any plan revisions; (g) Parental Rights and Responsibilities form reviewed and signed at least annually; (h) Preauthorization by MSDE of any environmental accessibility adaptations reimbursed through the Autism Waiver, if applicable; (i) Reportable Event forms concerning the waiver participant, if applicable; (j) Record of ongoing Autism Wavier service coordination encounters, including: (i) A description of the service; (ii) The location of the service; (iii) Date of contact and name of the parent/guardian or participant; (iv) Type of contact; (v) Supportive documentation of the service; and (vi) The Autism Wavier service coordinator’s printed name and signature; (k) Monthly tracking logs with Technical Eligibility Exemption Request Forms as applicable; and (l) A copy of the treatment plans for each applicable service provided or Reportable Event form, as applicable, if a treatment plan was not submitted. C. Autism Waiver Service Coordinator Requirements. (1) An Autism Waiver service coordinator shall: (a) Be employed by or under contract with a provider; (b) Be approved by the participant’s parent or parents; (c) Participate with the waiver multidisciplinary team in the development, or revision, of a participant’s waiver plan of care and in the waiver plan of care review; (d) Assist the participant in gaining access to the services recommended in the waiver plan of care; and (2) An Autism Waiver service coordinator who is chosen to provide services for a waiver participant shall have at least: (a) 1 year of relevant training or experience; and (b) A bachelor’s degree. (3) An Autism Waiver service coordinator shall complete at least 5 hours of training on the Autism Waiver, offered by the Department and MSDE, prior to rendering Autism Waiver service coordination in accordance with Regulations .04-1 and .04-2 of this chapter. (4) Autism Waiver service coordinators shall attend one Statewide training for Autism Waiver service coordinators per fiscal year. #### Regulation .04 Covered Services. *COMAR 10.09.52.04* A. The Program shall reimburse for the services in §§B—D of this regulation when the services have been documented, pursuant to the requirements of this chapter, as medically necessary. B. Initial IEP. (1) Definition. “Unit of service” means: (a) A completed initial IEP, signed by all members of the IEP team; and (b) At least one contact by the participant’s service coordinator or IEP team in person or by telephone with the participant or the participant’s parent, on the participant’s behalf relating to development of the IEP. (2) The covered services include convening and conducting an IEP team to: (a) Perform a multidisciplinary assessment of the participant; and (b) Develop an initial IEP. C. Ongoing Service Coordination. (1) Ongoing service coordination is provided by a participant's service coordinator. (2) Definition. For purposes of this section, “unit of service” means: (a) At least one contact per month by the service coordinator in person, by telephone, or by written progress notes or log with the participant or the participant's parent, on the participant's behalf relating to the child's ongoing service coordination; and (b) The provision of all other necessary services covered under these regulations. (3) As necessary, the Program shall include as covered services the following: (a) Acting as a central point of contact relating to IEP services for a participant; (b) Maintaining contact with: (i) The child's direct service providers, as applicable, which may include, but not be limited to, the child's Maryland Medicaid Managed Care Program provider or the Rare and Expensive case management provider; and (ii) A participant and the participant's parent through home visits, office visits, written notes, school visits, telephone calls, and follow-up service as necessary; (c) Implementing the IEP by referring the participant to direct service providers, assisting the participant in gaining access to services specified in the IEP, and providing linkage to agreed-upon direct service providers of services; (d) Discussing with direct service providers the services needed and available for the participant, assessing the quality and quantity of services being provided, following up to identify any obstacles to a participant’s utilization of services, coordinating the service delivery, and performing ongoing monitoring to determine whether the services are being delivered in an integrated fashion as recommended in the IEP and meet the participant’s current needs; (e) Providing a participant and the participant’s parent with information and direction that will assist them in successfully accessing and using the services recommended in the IEP; (f) Informing a participant’s parent of the participant’s and the family’s rights and responsibilities in regard to specific programs and resources recommended in the IEP; (g) Conducting, with a participant’s parent at a meeting or by other means acceptable to the parent and the service coordinator, a periodic review of the participant’s IEP every 6 months, or more frequently if warranted or the parent requests a review; and (h) Reviewing at least annually at a meeting or by other means acceptable to the participant’s parent and others involved in the review process: (i) The degree of a participant’s progress toward achieving the goals established in the IEP; and (ii) Whether the goals or recommended services need to be revised. (4) Administrative, supervisory, and monitoring services associated with the ongoing service coordination, including coordinating with the child's primary care provider, are included as part of the service. D. IEP Review. (1) Definition. “Unit of service” means: (a) A completed initial 60-day, interim, or annual IEP review as evidenced by a signed revised IEP or, if a revised IEP was not done, IEP team records documenting a meeting in which there is participation by at least two different disciplines; and (b) At least one contact by the service coordinator or IEP team in person, by telephone, or by written progress notes or log with the participant or the participant's parent, on the participant's behalf. (2) The covered services include convening and conducting an IEP team to: (a) Perform a multidisciplinary reassessment of the participant's status and service needs; and (b) Review and revise, as necessary, the participant’s IEP. #### Regulation .04-1 Covered Services — Autism Waiver Service Coordination — General Requirements. *COMAR 10.09.52.04-1* A. Autism Waiver Service Coordination is intended to: (1) Assist a waiver participant in gaining access to the Autism Waiver services approved in the waiver participant's waiver plan of care; (2) Assure coordination of the waiver participant's Autism Waiver services with other services received by the waiver participant; and (3) Assure that the waiver participant's full range of needs are adequately met, so as to assure the individual's: (a) Appropriate placement in the community; (b) Health and safety; (c) Quality of care; and (d) Access to authorized, necessary services. B. Waiver Service Coordinator. A waiver service coordinator employed by a provider shall assist with meeting the provider’s responsibilities specified in this regulation and Regulation .04-2 of this chapter. C. Waiver Multidisciplinary Team. A waiver multidisciplinary team: (1) Shall be convened by the local lead agency or local school system to: (a) Assess or reassess a waiver applicant's or waiver participant's need and eligibility for Autism Waiver services; and (b) Develop or review the waiver participant's waiver plan of care; and (2) Shall include: (a) The waiver participant's service coordinator; (b) The waiver applicant's or waiver participant's parent or parents; (c) A chairman who is the official representative of the local lead agency or local school system; and (d) Other service providers and individuals, as appropriate. D. Waiver Plan of Care. (1) A waiver participant's waiver plan of care is: (a) Initially developed on admission to the Autism Waiver; (b) Reviewed at least every 12 months; and (c) Revised as necessary by a waiver multidisciplinary team convened by the waiver participant's service coordinator. (2) A waiver participant’s waiver plan of care shall be submitted to MSDE before implementation. (3) Any revisions or additions to a waiver participant’s waiver plan of care shall be submitted to MSDE before implementation. (4) A waiver participant’s Autism Waiver service coordinator may make minor changes to the waiver participant’s waiver plan of care without reconvening the waiver multidisciplinary team, if the change is approved by the waiver participant’s parent or parents, and MSDE is notified. (5) A waiver participant’s initial or revised waiver plan of care shall include the: (a) Identification of Autism Waiver service or services to be delivered; (b) Service start date; (c) Service stop date; (d) Approved amount of services to be delivered; and (e) Provider or providers. E. Three types of Autism Waiver Service Coordination shall be provided, at times concurrently; (1) Waiver initial assessment; (2) Waiver ongoing service coordination; and (3) Waiver reassessment. #### Regulation .04-2 Covered Services — Autism Waiver Service Coordination — Specific Requirements. *COMAR 10.09.52.04-2* A. Waiver Initial Assessment. (1) Definition. For the purposes of this section, “unit of service” means: (a) A completed initial waiver plan of care, submitted to MSDE and signed by the service coordinator, the waiver participant or the parent or parents of a minor child, and all other members of the waiver multidisciplinary team; or (b) The provision of all necessary services specified in §A(2) of this regulation. (2) The covered services shall include: (a) Convening, coordinating, and participating on the waiver multidisciplinary team to perform the initial assessment and develop the waiver participant's initial waiver plan of care; (b) Assisting the waiver participant or the parent or parents of a minor child with scheduling and attending the appointments required for the waiver initial assessment; (c) Referring the waiver participant to approved Autism Waiver providers specified in the waiver plan of care; (d) Assisting the waiver participant with gaining access to the Autism Waiver services preauthorized in the waiver plan of care; (e) Assisting waiver participants with the waiver enrollment process specified in COMAR 10.09.56; and (f) Assisting with completion of forms and coordinating with the Department for determination of the waiver participant's Medicaid financial and technical eligibility in a timely fashion. B. Waiver Ongoing Autism Waiver Service Coordination. (1) Definition. For the purposes of this section, a monthly “unit of service” means: (a) At least one documented monthly contact by the waiver participant’s service coordinator in person, by telephone, via telehealth, or through written progress notes with the waiver participant or parent; (b) A quarterly visit to the waiver participant’s residence, residential program, or day program conducted in person or via telehealth, including at least one in-person visit to the waiver participant’s residence every 12 months; and (c) The provision of all other necessary services specified in §B(2) of this regulation. (2) The covered services shall include, as necessary: (a) Acting as a central point of contact relating to a waiver participant; (b) Coordinating Autism Waiver Service Coordination with the Department and MSDE; (c) Referring the waiver participant to the Autism Waiver providers specified in the waiver plan of care; (d) Assisting the waiver participant with gaining access to the Autism Waiver services preauthorized in the waiver plan of care according to the type, level, amount, frequency, and duration; (e) Assisting with coordination of the Autism Waiver service delivery; (f) Providing the waiver participant and the parent or parents with information and direction to assist them with accessing and successfully utilizing the Autism Waiver services preauthorized in the waiver plan of care; (g) Maintaining contact with the waiver participant’s waiver and other service providers and with the waiver participant or parent through documented in-person visits, telehealth contact, telephone calls, mailings, and follow-up services as necessary; (h) Following up to identify any problems or obstacles to the waiver participant's appropriate receipt of the Autism Waiver services specified in the waiver plan of care; (i) Assisting to resolve any conflicts or crises in delivery of the waiver participant's Autism Waiver services which jeopardize the waiver participant's community placement or the health and safety of the waiver participant or another individual; (j) Making minor changes to the waiver participant’s waiver plan of care as necessary, without reconvening the waiver multidisciplinary team, if the change is approved by the waiver participant’s parent or parents and submitted to MSDE; (k) Assuring that the necessary documentation is maintained in the waiver participant’s file, as specified in Regulation .03-1B(5) of this chapter; (l) Providing MSDE with required information in the established time frame on waiver participants enrolled in the Autism Waiver; and (m) Monitoring on an ongoing basis: (i) The appropriateness of the type, amount, duration, and quality of the Autism Waiver services received by a waiver participant; (ii) Whether a waiver participant's Autism Waiver services are delivered in an integrated and coordinated fashion and adequately meet the waiver participant's current needs; and (iii) The impact of the Autism Waiver services on the waiver participant's health, safety, development, relationships with family members and other persons, home environment, educational program, quality of life, and life satisfaction. C. Waiver Reassessment. For the purposes of this section, “unit of service” means: (1) A completed waiver plan of care review at least every 12 months, with revisions as necessary, which is submitted to MSDE and signed by the Autism Waiver service coordinator, the waiver participant or the parent or parents of a minor child, and all other members of the waiver multidisciplinary team; (2) Assisting waiver participants with the waiver’s eligibility redetermination process, as specified in COMAR 10.09.56; (3) Assisting families with making informed choices in selecting between a home and community-based waiver documented in the Autism Waiver Transitioning Youth Service Delivery Option Form or other documentation as required; (4) Assisting the waiver participant or the parent or parents of a minor child with completion and submission of the application forms and accompanying documentation for the Medicaid financial and technical eligibility redetermination, in coordination with the Department, before the deadline established by the Department; (5) Completing a risk assessment within 45 days of receiving notification of eligibility by the Department using the Autism Waiver Risk Assessment form; (6) Completing a risk assessment if the participant’s status changes, to ensure the applicant can be safely maintained in a home and community-based setting utilizing Autism Waiver services; or (7) Providing written notice to a MSDE representative of the participant’s ineligibility for the Autism Waiver. #### Regulation .05 Limitations. *COMAR 10.09.52.05* A. Service Coordination for Children with an IEP or enrolled in the Autism Waiver is advisory in nature except for Autism Waiver Service Coordination, covered under Regulations .03-1, .04-1, and .04-2 of this chapter. B. A restriction may not be placed on a qualified participant’s option to receive the services covered under this chapter except that Autism Waiver Service Coordination, as defined by Regulations .03-1, .04-1, and .04-2 of this chapter, is required for waiver eligible persons who choose to enroll in the Autism Waiver. C. The services covered under this chapter may not restrict or otherwise affect the: (1) Participant's eligibility for Title XIX benefits or other available benefits or programs except as limited by §E of this regulation; (2) Freedom of the participant's parent to select from all available services for which the participant is found to be eligible; (3) Participant's parent's free choice among qualified providers of services covered under this chapter, as well as among service providers of other services for which the participant qualifies; or (4) Provider's right to bill the Program for other covered Program services. D. Service Coordination for Children with an IEP or enrolled in the Autism Waiver may not be: (1) Provided as an integral and inseparable part of another covered Program service; (2) Provided as an administrative function necessary for the proper and efficient operation of the State's Medical Assistance plan; or (3) Delivered as part of institutional discharge planning. E. Reimbursement may not be made for the services covered under this chapter if the participant is receiving a similar case management service under another Program authority. F. Reimbursement may not be made to providers that participate on, but do not convene, an IEP team or teams, for ongoing service coordination for residential students who reside in facilities that receive Medical Assistance reimbursement for residential services. G. Only waiver participants may receive Autism Waiver Service Coordination, covered under Regulations .04-1 and .04-2 of this chapter. #### Regulation .06 Payment Procedures. *COMAR 10.09.52.06* A. Request for Payment. (1) An approved provider shall submit requests for payment for the services covered under this chapter according to procedures established by the Program. The Program reserves the right to return to the provider, before payment, all requests not properly completed. (2) A provider shall: (a) Bill the Program for the appropriate fee or fees specified in §C of this regulation; (b) Accept payment from the Program as payment in full for the services covered under this chapter and make no additional charge to the participant or any other party; and (c) Submit a request for payment in the manner specified by the Program, that includes the: (i) Date or dates of service, (ii) Participant's name and Medical Assistance number, (iii) Provider’s name, location, and Medicaid provider number; and (iv) Nature, unit or units, and procedure code or codes of covered services provided. (3) Providers that convene or conduct an IEP team or teams in accordance with COMAR 13A.05.01 may bill the Program for all IEP-related services contained in this chapter. (4) Providers that participate on, but do not convene or conduct, an IEP team or teams, may only bill for ongoing service coordination, only for day students. These providers may not bill for ongoing service coordination for the residential students who reside in facilities that receive Medical Assistance reimbursement for residential services. B. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. C. The Program shall make payment only to one qualified provider for covered services rendered on a particular date of service to a participant and according to the following fee schedule covered under this chapter: (1) Initial IEP: no more than one unit of service may be reimbursed per participant ... $500; (2) Ongoing IEP service coordination: no more than one unit of service per month may be reimbursed for a participant ... $150; (3) IEP review: at most, three units of service may be reimbursed for a participant in a 12-month period ... $275; (4) Waiver initial assessment: No more than one unit of service may be reimbursed per waiver participant ... $500; (5) Waiver ongoing service coordination: No more than one unit of service per month may be reimbursed for a waiver participant ... $150; (6) Waiver reassessment: At most, four units of service may be reimbursed for a waiver participant in a 12-month period ... $275. D. The Program may not make payment for ongoing service coordination when, for the same month, payment is made to the provider for furnishing to the participant: (1) An initial IEP service; or (2) An IEP review service. E. The Program may not make payment for more than one IEP review in the same month, unless a subsequent review is documented as an emergency. F. The Program may not make payment for an initial IEP and an IEP review in the same month, unless a review is documented as an emergency. G. If an IEP review takes more than one meeting to complete, the Program shall only make payment for the meeting during which the review was signed. H. A provider shall be paid the lesser of: (1) The provider's usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The rate established under §C of this regulation #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.52.07* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.52.08* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.52.09* Appeal procedures are those set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.52.10* State regulations are interpreted in accordance with COMAR 10.09.36.10. ### Chapter 53 — Early and Periodic Screening, Diagnosis, and Treatment: Nursing Services for Individuals Younger than 21 Years Old **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective May 5, 1993 (20:11 Md. R. 911); adopted permanently effective August 2, 1993 (20:15 Md. R. 1220) **Administrative History:** Regulations .01, .03—.07 amended as an emergency provision effective June 1, 1994 (21:13 Md. R. 1152); amended permanently effective September 26, 1994 (21:19 Md. R. 1635) **Administrative History:** Regulations .01 and .03—.06 amended as an emergency provision effective January 1, 1997 (23:26 Md. R. 1856); amended permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01B amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); August 27, 2007 (34:17 Md. R. 1507); March 10, 2008 (35:5 Md. R. 641); April 1, 2014 (41:6 Md. R. 379); August 21, 2023 (50:16 Md. R. 726) **Administrative History:** Regulation .02 amended effective January 31, 2005 (32:2 Md. R. 146) **Administrative History:** Regulation .03 amended effective January 31, 2005 (32:2 Md. R. 146); April 1, 2014 (41:6 Md. R. 379) **Administrative History:** Regulation .03C, H amended effective August 23, 1999 (26:17 Md. R. 1323) **Administrative History:** Regulation .03D, G amended effective March 10, 2008 (35:5 Md. R. 641) **Administrative History:** Regulation .04 amended effective March 10, 2008 (35:5 Md. R. 641); April 1, 2014 (41:6 Md. R. 379) **Administrative History:** Regulation .04A amended effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .04A, C amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146) **Administrative History:** Regulation .04I adopted effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .05 amended effective April 1, 2014 (41:6 Md. R. 379); June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .05A amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); March 10, 2008 (35:5 Md. R. 641) **Administrative History:** Regulation .05C repealed effective March 10, 2008 (35:5 Md. R. 641) **Administrative History:** Regulation .05E adopted effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .06 amended effective August 23, 1999 (26:17 Md. R. 1323); January 31, 2005 (32:2 Md. R. 146); April 1, 2014 (41:6 Md. R. 379) **Administrative History:** Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .07 amended effective July 3, 2006 (33:13 Md. R. 1064); October 31, 2011 (38:22 Md. R. 1345); April 1, 2014 (41:6 Md. R. 379); October 24, 2016 (43:21 Md. R. 1166); May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .07B amended as an emergency provision effective January 1, 2000 (27:2 Md. R. 140); amended permanently effective May 1, 2000 (27:8 Md. R. 798) **Administrative History:** Regulation .07B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) **Administrative History:** Regulation .07B amended effective April 6, 2009 (36:7 Md. R. 524); August 21, 2023 (50:16 Md. R. 726) **Administrative History:** Regulation .07C amended effective November 14, 2022 (49:23 Md. R. 995); August 21, 2023 (50:16 Md. R. 726); May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .07D amended as an emergency provision effective July 1, 2007 (34:15 Md. R. 1347); amended permanently effective September 24, 2007 (34:19 Md. R. 1650) **Administrative History:** Regulation .07D amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective December 1, 2008 (35:24 Md. R. 2077) **Administrative History:** Regulation .07D amended effective March 22, 2010 (37:6 Md. R. 477) **Administrative History:** Regulation .07E repealed effective March 10, 2008 (35:5 Md. R. 641) **Administrative History:** Regulation .07F adopted effective January 1, 2018 (44:26 Md. R. 1214) #### Regulation .01 Definitions. *COMAR 10.09.53.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Caregiver” means a willing and able individual who is trained in providing care to the participant. (2) “Certified medication technician (CMT)” means an individual, regardless of title, who: (a) Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing; (b) Is certified by the Board under COMAR 10.39.04; and (c) Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. (3) “Certified nursing assistant (CNA)” means an individual, regardless of title, who: (a) Is certified by the Maryland Board of Nursing under COMAR 10.39.05; and (b) Routinely performs nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. (4) “Delegated nursing services” has the meaning stated in COMAR 10.27.11. (5) Employment. (a) “Employment” means the condition of having paid work. (b) “Employment” includes job training or classes required to obtain government licensure or certification to engage in an occupation or profession, and work to fulfill requirements to obtain Temporary Cash Assistance or other public benefits. (6) “Department” has the meaning stated in COMAR 10.09.36.01. (7) “Early and Periodic Screening, Diagnosis, and Treatment (EPSDT)” means the provision of preventive health care under 42 CFR §441.50 et seq., including medical and dental services, in order to assess growth and development and to detect and treat health problems in Medical Assistance recipients under 21 years old. (8) “Electronic visit verification (EVV)” has the meaning stated in COMAR 10.09.36.03-2. (9) “Emergency medical condition” means a health condition manifested by symptoms of sufficient severity that the absence of immediate medical attention could reasonably be expected by a prudent lay individual possessing an average knowledge of health and medicine to result in: (a) Placing health in jeopardy; (b) Serious impairment to bodily functions; (c) Serious dysfunction of any bodily organ or part; or (d) Development or continuance of severe pain. (10) “Emergency service” means a service or care rendered to a recipient exhibiting an emergency medical condition as defined in §B(3) of this regulation. (11) “EPSDT screen” means the complete package of various health screening procedures, required by the State periodicity schedule, or a partial screen, that an EPSDT participant receives. (12) “Home” means the place of residence, occupied by the recipient, other than a residence or facility where private duty nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment. (13) “Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10. (14) "Home health aide (HHA)” means an individual, regardless of title, who meets all the conditions of participation specified in: (a) 42 CFR §484.36; and (b) Health Occupations Article, Title 8, Annotated Code of Maryland. (15) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (16) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (17) “Nurse” means a person who is licensed to practice as a registered nurse (RN) or licensed practical nurse (LPN) in the jurisdiction in which services are provided. (18) “Nursing care plan” means a plan developed by a registered nurse that identifies the patient's diagnoses and needs, the goals to be achieved, and the interventions required to meet the patient's medical condition. (19) “Participant” means a recipient who is eligible for and receiving services in accordance with the provisions of this chapter. (20) “Plan of care” means an individualized care plan, written in collaboration with the participant or family, including the plan developed under COMAR 10.09.27 and 10.09.69, which outlines a plan of action to meet the goals or expected outcomes for the participant. (21) “Preauthorization” means the approval required from the Department or its designee before services may be rendered. (22) “Primary medical provider (PMP)” means the medical provider who functions as the principal medical provider to the participant including a physician, certified nurse midwife, or nurse practitioner. (23) “Private duty nursing services” means skilled nursing services for recipients who require more individual and continuous care than is available under the home health program, and which are provided by a registered nurse or a licensed practical nurse, in a recipient's own home or another setting when normal life activities take the recipient outside his or her home. (24) “Program” has the meaning stated in COMAR 10.09.36.01. (25) “Progress note” means a signed and dated written notation by the home care nurse which: (a) Summarizes facts about the care given and the participant's responses during a given period of time; (b) Specifically addresses the established goals of treatment; (c) Is consistent with the participant's plan of care; and (d) Is written during the course of care. (26) “Provider” has the meaning stated in COMAR 10.09.36.01. (27) “Recipient” has the meaning stated in COMAR 10.09.36.01. (28) “Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05. (29) “School” means courses or classes for the acquisition of a General Education Diploma, high school diploma, associate's degree, or a first-time bachelor's degree. (30) “Supervision” means authoritative, procedural guidance by a licensed registered nurse for the accomplishment of a function or activity, as well as the process of critical watching, directing, and evaluating another's performance. (31) “Urgent service” means a service or care for a medical condition that is manifested by symptoms of sufficient severity that the absence of medical attention within 48 hours could reasonably be expected, by a prudent lay individual who possesses an average knowledge of health and medicine, to result in an emergency medical condition. (32) “Witness” means the recipient or an individual who, on behalf of the recipient, is able to personally verify that the recipient received private duty nursing services. #### Regulation .02 Licensing Requirements. *COMAR 10.09.53.02* A. Nurses rendering or supervising the provision of private duty nursing services shall be licensed in accordance with licensing requirements specified in COMAR 10.09.36.02. B. An agency providing services pursuant to this chapter shall meet all applicable licensure and certification requirements of the jurisdiction in which the agency is providing services. #### Regulation .03 Conditions for Participation. *COMAR 10.09.53.03* Requirements for participation for nursing services are that a provider shall: A. Meet the general Medical Assistance provider requirements as specified in COMAR 10.09.36.03; B. Be licensed as a: (1) Residential service agency under COMAR 10.07.05; or (2) Home health agency under COMAR 10.07.10; C. Have on staff at least one registered nurse supervisor who: (1) Provides and documents initial direction to the participant's caregivers and assigned nurse, CNA, or HHA regarding the provision of nursing services to the participant; (2) Documents that each assigned nurse, CNA, or HHA providing home care services has the necessary skills to meet the participant's needs including knowledge of any medical equipment in use by the participant; (3) Conducts and documents a monthly review of the progress notes to assure adequacy and quality of care; (4) Makes supervisory visits in the participant's home or another site where the participant is receiving nursing services and regularly evaluates the assigned nurse’s performance of the nursing services in accordance with COMAR 10.27.09 and 10.27.10; (5) Makes supervisory visits in the participant's home or another site where the participant is receiving CNA or HHA services and regularly evaluates their performance of the delegated nursing tasks in accordance with COMAR 10.27.11; (6) Completes a note after each supervisory visit that becomes part of the participant's file; (7) Provides and documents training to the participant's caregiver or caregivers and the individual or individuals providing backup to the caregiver or caregivers; and (8) Develops an initial nursing care plan which is reevaluated 30 days after the initial assessment and modified as necessary to meet the participant's nursing needs; D. Ensure that each nurse, CNA, or HHA rendering services to a participant: (1) Has a valid, nontemporary, nursing license or certification to provide nursing, CNA, or HHA services in the jurisdiction in which services are rendered; (2) Has completed a skills checklist and demonstration of competency on an annual basis that was observed, documented, and verified by the signature of the RN supervisor or an RN designated by the supervisor; (3) Demonstrates to the provider's nurse supervisor sufficient specialized training and experience to deliver the level of service required by each participant to whom the nurse, CNA, or HHA renders direct care; (4) Demonstrates to the provider's nurse supervisor, on a continuing basis, the ability to carry out competently the services specified in a participant's care plan, subject to review by the Department or its designee; (5) Participates in the multidisciplinary team process, if appropriate, including attending team meetings, for children receiving home and community-based services under COMAR 10.09.27, and renders services in accordance with the plan of care recommended by the team and approved by the Department or its designee, including any subsequent revisions to that plan; (6) Is currently certified in cardiopulmonary resuscitation (CPR) at the time services are rendered; (7) Provides care and services in accordance with generally accepted nursing practices; (8) Knows how to contact the provider and the registered nurse supervisor; (9) Provides care according to the provider's policies for the delivery of services to participants as described in §E of this regulation; (10) Has not been convicted of, received a probation before judgment for, or entered a plea of nolo contendere to a felony of any crime involving moral turpitude or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; and (11) If a CNA or HHA, has completed the training and been certified by the Maryland Board of Nursing as a CMT; E. Develop policies for the delivery of services to participants, including policies on the following: (1) Skill assessments; (2) Emergency procedures; (3) Administration of drugs, including controlled substances; (4) Clinical record maintenance; (5) Job description and educational qualifications of all staff members; (6) Clinical management; (7) Infection control procedures; (8) Disposal of biomedical waste; (9) Maintenance of equipment; (10) Supervision, including appropriate frequencies of direct supervision; (11) Staffing and scheduling, including contingency plans for care of the participant in the absence of the caregiver, assigned nurse, CNA, or HHA; (12) A quality assurance program; (13) Procedures for resolution of complaints; and (14) Coordination of care, when appropriate, including: (a) Delineation of service responsibilities when other service providers are involved in a participant's care; (b) Notification to participants of each service provider's responsibilities in these instances; and (c) Development of a discharge plan when the participant, the participant's legal representative, or the provider terminates care; F. Conduct a reference check on each nurse, CNA, or HHA rendering care to a participant consisting of: (1) A documented face-to-face interview between agency representatives and the nurse, CNA, or HHA; (2) Documented efforts at verification of past employment history; and (3) A criminal background check to include, when caring for a child, an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services, in accordance with Family Law Article, §5-561, Annotated Code of Maryland; G. Maintain a personnel folder at the agency's business office for each nurse, CNA, and HHA which shall include the following: (1) Verification of current nursing license or certification; (2) A copy of the current CPR certification; (3) Documentation related to: (a) The face-to-face interview; (b) Verification that any nurse who serves a participant younger than 19 years old has past employment which shall include at least 1 year of clinical experience which includes pediatric direct patient care within the last 3 years; and (c) Verification of the CNA or HHA’s past employment which shall include at least 1 year of clinical experience within the last 3 years; (4) Written verification of a criminal background check; and (5) Documentation of a completed skills checklist signed and dated by the registered nurse supervisor or the registered nurse supervisor designee and the assigned nurse, CNA, or HHA; H. Provide the participant or the participant's caregiver with the following written information: (1) Name and phone number of the provider's contact person; and (2) Name of each nurse, CNA, or HHA assigned by the provider to render services to the participant; I. Provide a mechanism for the timely investigation of written complaints such that: (1) Disruption of service does not result from the filing of a complaint; (2) Complete files are maintained on the source, category, and disposition of the complaint; (3) A summary report of the complaint investigation is made available to the Department or the Department's designee; (4) A summary report of the complaint investigation is made available for public inspection, upon request; and (5) When a complaint investigation is not conducted, reasons are documented and forwarded with the complaint to the Department or the Department's designee; J. Provide back-up services when the assigned nurse, CNA, or HHA is unable to provide the services; K. Ensure a nurse, CNA, or HHA is not scheduled to work for more than a total of 60 hours per week or 16 consecutive hours and that the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department; L. Demonstrate on a continuing basis the capacity to provide services to participants in the amount and level required in the participant's care plan including the development of a contingency plan to assure coverage; M. Provide the participant or the participant's representative with: (1) At least 14 days written notice of termination of services when it is the provider's decision to terminate and the medical condition remains unchanged; and (2) A copy of a developed discharge plan if the participant, the participant's representative, or the provider elects to discontinue the provider's services to the participant; N. Ensure that each nurse, CNA, or HHA rendering services to a participant: (1) Completes a progress note for each shift which becomes part of the participant's permanent record; (2) Is providing services which follow the participant's care plan; and (3) Is providing services ordered by the participant's primary medical provider before the start of care and renewed every 60 days as indicated by the participant’s primary medical provider’s signed and dated orders; O. Maintain sufficient documentation to demonstrate that the requirements of this chapter are met. #### Regulation .04 Covered Services. *COMAR 10.09.53.04* A. The Program shall cover services rendered by a nurse, CNA, or HHA when the: (1) Services are ordered by the participant's primary medical provider and renewed every 60 days after that; (2) Services are directly related to the plan of care; (3) Services are described in the nursing care plan and progress notes; (4) Services are of a scope that is more individual and continuous than what is available under the home health program; (5) Services are delivered in the recipient's home, or other setting when normal life activities take the recipient outside the home; (6) Services include supervision of family caregivers in the home while family caregivers practice the skills necessary to provide care to the recipient in accordance with the established plan of care; (7) Services are preauthorized in accordance with Regulation .06 of this chapter; (8) Services are received by the participant as documented by the signature of the participant or the participant’s representative on the nursing provider’s official form; (9) Services are determined medically necessary for a participant after the provider has completed an initial nursing assessment that reflects the participant’s need for an awake and alert caregiver; (10) Participant has at least one caregiver willing and able to accept responsibility for the participant’s care when the nurse, CNA, or HHA is not available; (11) Caregiver provides documentation of each of the following when applicable: (a) The caregiver’s work schedule along with commuting times; (b) The caregiver’s school attendance as defined in Regulation .02 of this chapter along with commuting times; and (c) Emergency circumstances, as determined by the Department, including but not limited to the inability of the primary caregiver to provide care due to hospitalization or an acute debilitating illness for up to a 60-day period; and (12) Services are provided only in the absence of the willing and able caregiver during sleeping hours and during the times documented in §A(11) of this regulation. B. The Program shall cover nursing services rendered by a registered nurse when: (1) The complexity of the services or the condition of a participant requires the judgment, knowledge, and skills of a registered nurse in accordance with COMAR 10.27.09 and the services cannot be: (a) Performed by a licensed practical nurse in accordance with COMAR 10.27.10; and (b) Delegated to a CNA or HHA pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland and in accordance with COMAR 10.27.11; (2) Sufficient documentation is maintained by the registered nurse including signed and dated progress notes which are reviewed by the registered nurse supervisor; (3) Supervisory visits are conducted and documented by the registered nurse supervisor based on acceptable standards of practice; and (4) Services are preauthorized by the Department. C. The Program shall cover nursing services rendered by a licensed practical nurse when: (1) The complexity of the services or the condition of a participant requires the judgment, knowledge, and skills of a licensed practical nurse in accordance with COMAR 10.27.10 and the services: (a) Do not require the knowledge and skills of a registered nurse in accordance with COMAR 10.27.09; and (b) Cannot be delegated to a CNA or HHA pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11; (2) Sufficient documentation is maintained by the licensed practical nurse including signed and dated progress notes which are reviewed by the registered nurse supervisor; (3) Supervisory visits are conducted and documented by the registered nurse supervisor based on acceptable standards of practice; and (4) Services are preauthorized by the Department. D. The Program shall cover delegated nursing services provided by a CNA or HHA who is also certified as a CMT when: (1) The complexity of the service or the condition of a participant requires the judgment, knowledge, and skills of the CNA or HHA for at least 2 or more continuous hours; (2) The services provided include but are not limited to: (a) Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or (b) Other nursing services properly delegated by a nurse pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland, and in accordance with COMAR 10.27.11; (3) Sufficient documentation is maintained by the CNA or HHA including signed and dated progress notes which are reviewed by the nurse supervisor; and (4) Supervisory visits are conducted and documented by a registered nurse supervisor in accordance with COMAR 10.27.09 and 10.27.11. E. The Program shall cover a provider's initial assessment of a participant's medical need for services when the assessment: (1) Is 3 hours or less; (2) Does not require preauthorization; (3) Demonstrates: (a) A comprehensive assessment of the recipient's health status; (b) An assessment of the need for services; (c) An assessment of the scope and duration of services to be provided; (d) An assessment of the recipient's residence; and (e) Consultation with the primary medical provider, and a multidisciplinary team if the participant is receiving services under COMAR 10.09.27, to confirm the need for services and to develop a plan of care; and (4) Is conducted by a licensed registered nurse. F. If a need for services is confirmed during a participant's initial assessment, the registered nurse, in conjunction with the participant's primary medical provider, shall develop a care plan. When a participant also receives services under COMAR 10.09.27, the nurse or registered nurse supervisor shall participate as a member of the multi-disciplinary team and recommend a plan of care. The care plan shall be reviewed and updated to reflect the current service orders and shall include: (1) Prognosis; (2) Diagnoses; (3) Treatment; (4) Treatment goals; (5) Services required, including specific nursing procedures; (6) Frequency of visits (that is, hours of nursing care ordered for each day); (7) Duration of treatment; (8) Functional limitations; (9) Permitted and prohibited activities; (10) Diet; (11) Medications; (12) Mental status; (13) A list of medical supplies related to each nursing procedure and how these are to be used in the participant's care: (14) A list of durable medical equipment related to each nursing procedure and how the equipment is to be used in the participant's care; (15) Safety measures to protect against injury; (16) Emergency plan; (17) Contingency plan for back-up coverage; (18) Nurse's role in including the family in the provision of care; (19) Plan to decrease services when the participant's condition improves or as the caregivers become better able to meet the participant's needs; and (20) Other appropriate items. G. The Department may preauthorize on a short-term basis services for assessment purposes only, when medical information is insufficient to determine medical necessity; H. Services shall be decreased as the caregivers become better able to meet the participant's needs. I. The Program shall cover nursing services ordered by the participant's primary medical provider when the primary medical provider is an individual who is enrolled as a provider in the Program with an active status on the date of service. #### Regulation .05 Limitations. *COMAR 10.09.53.05* A. Under this chapter, the Program does not cover the following: (1) Home health services that are covered under COMAR 10.09.04; (2) Services rendered by a nurse, CNA, or HHA who is a member of the participant's immediate family or who ordinarily resides with the participant; (3) Custodial services; (4) Services not deemed medically necessary at the initial assessment or the most recent plan of care review; (5) Services delivered by a nurse, CNA, or HHA who is not directly supervised by a registered nurse who documents all supervisory visits and activities; (6) Services not preauthorized by the Department or the Department's designee, with the exception of the initial assessment; (7) Services provided to a participant in a hospital, residential treatment center, or an intermediate care facility for individuals with intellectual disabilities or a residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment; (8) Services not directly related to the plan of care; (9) Services specified in the plan of care, when the plan of care has not been signed by the recipient or the recipient's legally authorized representative, the Department or the Department's designee, and the recipient's primary medical provider, when the services are covered under COMAR 10.09.27; (10) Services described in the plan of care whenever a major change occurs in the recipient's medical condition or skilled nursing care needs; (11) Services not ordered by the recipient's primary medical provider as a result of a partial or complete EPSDT screen; (12) Services specified in Regulation .04 of this chapter which duplicate or supplant services rendered by the recipient's family caregivers or primary caregivers as well as other insurance, privilege, entitlement, or program services that the recipient receives or is eligible to receive; (13) Services specified in Regulation .04 of this chapter to recipients eligible for any third-party liability coverage of those services; (14) Services provided for the convenience or preference of the recipient or the primary caregiver rather than as required by the recipient's medical condition; (15) Services which are not initially ordered before the start of care and renewed every 60 days by the participant's primary medical provider; (16) Services provided by a nurse, CNA, or HHA who does not possess a valid, current, and nontemporary nursing license or certifications to provide services in the jurisdiction in which services are rendered; (17) Services provided by a nurse, CNA, or HHA who does not have a current cardiopulmonary resuscitation (CPR) certification for the period during which the services are rendered; (18) Direct payment for supervisory visits that do not meet acceptable standards of practice in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11; (19) Services rendered to a participant by a nurse, CNA, or HHA in the assigned staff's home; (20) Services not documented; and (21) Respite services. B. The Program shall only cover one-to-one nursing when a participant's condition requires that level of service and shared services are not an option. C. Nursing services may only be provided to EPSDT eligible individuals under 21 years old. D. The Program does not cover nursing services ordered by an: (1) Individual who is not enrolled as a provider in the Program with an active status on the date of service; and (2) Entity, facility, or another provider that is not an individual. #### Regulation .06 Preauthorization Requirements. *COMAR 10.09.53.06* A. The Department or the Department's designee shall preauthorize nursing services, according to medical necessity, frequency, and duration, as a prerequisite to payment beyond the initial assessment. B. Preauthorization is issued when: (1) Program procedures are met; (2) Program limitations are met; (3) The requirements specified in this chapter are met; and (4) The Department or the Department's designee determines that the services are medically necessary. C. The provider shall request the Department or the Department's designee to authorize the initiation or continuance of nursing services before the initiation or continuation of services unless services are rendered to a participant in need of emergency or urgent medical services. D. The provider shall request the Department or the Department's designee to authorize emergency or urgent medical services rendered to a recipient not later than the close of business the next business day after the emergency or urgent service is rendered. E. If nursing services in excess of the initial authorized amount are necessary, then: (1) The assigned nurse or registered nurse supervisor shall contact the primary medical provider for approval of additional hours; and (2) The provider shall request the Department or the Department's designee to authorize the increase in services before the initiation of change for nonemergency and nonurgent changes and not later than the close of business the next business day after the emergency or urgent service is rendered. F. An existing preauthorization shall remain in effect when a recipient is discharged from a hospital admission of less than or equal to 72 consecutive hours and there is no substantive change in the recipient's plan of care requiring a change in the number of authorized units of nursing services. G. Since preauthorization does not guarantee Program eligibility, the provider is responsible for checking for Program eligibility on the date of service. H. Preauthorization is only valid for services initiated within the period authorized by the Department or the Department's designee. I. Preauthorization is only valid for services rendered over a fixed period of time, such as: (1) The periods designated for recipients who are served under COMAR 10.09.27; (2) For the designated time initially ordered by the recipient's primary care provider, up to 30 days; and (3) For intervals of 60 days after that or as considered necessary by the Department or the Department's designee. J. Authorization shall be rescinded by the Department or the Department's designee when: (1) The recipient is terminated from care; (2) The participant is admitted to a residential treatment center, an intermediate care facility for individuals with intellectual disabilities, or a nursing facility; (3) The recipient is discharged from a hospital admission of less than or equal to 72 consecutive hours resulting in a change in the recipient's plan of care; (4) The recipient is admitted to a hospital for a period of more than 72 consecutive hours; or (5) The Department or the Department's designee determines that the care is no longer medically necessary. #### Regulation .07 Payment Procedures. *COMAR 10.09.53.07* A. Payment procedures are as set forth in COMAR 10.09.36.04 and .06. B. Payments. (1) Payments shall be made directly to a qualified provider. (2) To receive payment for services under Regulation .04 of this chapter, a provider and its workers shall use the electronic visit verification method and data management system approved by the Department to document time and submit claims in accordance with COMAR 10.09.36.03-2. (3) Providers shall be paid the lesser of: (a) The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rate established according to the fee schedule published by the Department. C. Rates. (1) Effective July 1, 2022, through December 31, 2023, rates for the services outlined in this regulation shall be as follows: (a) $17.87 for 15 minutes of services provided by a registered nurse to one participant; (b) $12.32 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence; (c) $11.58 for 15 minutes of services provided by a licensed practical nurse to one participant; (d) $7.99 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence; (e) $6.12 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant; (f) $4.22 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence; (g) $5.08 for 15 minutes of services provided by a CNA or HHA to one participant; (h) $3.50 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and (i) A flat rate of $71.41 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA. (2) Effective January 1, 2024 through June 30, 2024, rates for the services outlined in this regulation shall be as follows: (a) $19.2951 for 15 minutes of services provided by a registered nurse to one participant; (b) $13.3101 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence; (c) $12.5061 for 15 minutes of services provided by a licensed practical nurse to one participant; (d) $8.6266 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence; (e) $6.6105 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant; (f) $4.5611 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence; (g) $5.4874 for 15 minutes of services provided by a CNA or HHA to one participant; (h) $3.7848 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and (i) A flat rate of $77.13 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA. (3) Effective July 1, 2024, rates for the services outlined in this regulation shall be as follows: (a) $19.8739 for 15 minutes of services provided by a registered nurse to one participant; (b) $13.7094 for 15 minutes of services provided by a registered nurse to each of two or more participants in the same residence; (c) $12.8813 for 15 minutes of services provided by a licensed practical nurse to one participant; (d) $8.8854 for 15 minutes of services provided by a licensed practical nurse to each of two or more participants in the same residence; (e) $6.8088 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to one participant; (f) $4.6979 for 15 minutes of services provided by a CNA or HHA who is also certified as a CMT to each of two or more participants in the same residence; (g) $5.6520 for 15 minutes of services provided by a CNA or HHA to one participant; (h) $3.8983 for 15 minutes of services provided by a CNA or HHA to two or more participants in the same residence; and (i) A flat rate of $79.44 per visit for a registered nurse supervisory visit of a nurse, CNA, or HHA. (4) The Program’s rates as specified in this regulation shall adjust each year, subject to the limitations of the State budget. D. The nursing services provider shall identify the individual who ordered the nursing services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.53.08* Recovery and reimbursement are those set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.53.09* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.53.10* Appeal procedures are those set forth in COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.53.11* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 54 — Home and Community-Based Options Waiver **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, 15-132, and 15-141.2, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—19 adopted as an emergency provision effective July 22, 1993 (20:16 Md. R. 1275); adopted permanently effective October 26, 1993 (20:21 Md. R. 1654) **Administrative History:** Chapter revised effective December 25, 2000 (27:25 Md. R. 2281) **Administrative History:** Chapter revised effective June 21, 2004 (31:12 Md. R. 912) **Administrative History:** Regulation .05A amended effective July 17, 2006 (33:14 Md. R. 1164) **Administrative History:** Regulation .33C amended effective June 20, 2005 (32:12 Md. R. 1046); July 17, 2006 (33:14 Md. R. 1164) **Administrative History:** Chapter revised effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .03C amended effective September 20, 2010 (37:19 Md. R. 1284) **Administrative History:** Regulation .14 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective December 1, 2008 (35:24 Md. R. 2078) **Administrative History:** Regulation .14-1 adopted effective April 15, 2013 (40:7 Md. R. 610) **Administrative History:** Regulation .15 amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078) **Administrative History:** Regulation .17 adopted as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); adopted permanently effective September 21, 2009 (36:19 Md. R. 1436) **Administrative History:** Regulation .30 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective December 1, 2008 (35:24 Md. R. 2078) **Administrative History:** Regulation .30-1 adopted effective April 15, 2013 (40:7 Md. R. 610) **Administrative History:** Regulation .32F, G amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078) **Administrative History:** Regulation .32H adopted as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); adopted permanently effective September 21, 2009 (36:19 Md. R. 1436) **Administrative History:** Regulation .33A, C amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective December 1, 2008 (35:24 Md. R. 2078) **Administrative History:** Regulation .33C amended effective April 6, 2009 (36:7 Md. R. 524); February 8, 2010 (37:3 Md. R. 176); October 31, 2011 (38:22 Md. R. 1346); April 15, 2013 (40:7 Md. R. 610) **Administrative History:** Regulation .33D adopted effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulations .01—.37 repealed and new Regulations .01—.27 adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .01 amended effective November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .04A amended effective November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .04D adopted effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .10-1 adopted effective December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .13 amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .14 amended effective January 30, 2017 (44:2 Md. R. 84); November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .15A amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .16A amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .16E, F, G adopted effective November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .17 amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .17D, E, F adopted effective November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .18 amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .18-1 adopted effective December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .18-1 amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .19 amended effective January 30, 2017 (44:2 Md. R. 84) **Administrative History:** Regulation .21B amended effective December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .21C adopted effective December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .22A amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .22C amended effective July 4, 2016 (43:13 Md. R. 712); November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .22D amended effective January 30, 2017 (44:2 Md. R. 84); May 20, 2019 (46:10 Md. R. 486); November 27, 2023 (50:23 Md. R. 1004); May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Definitions. *COMAR 10.09.54.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means tasks or activities that include, but are not limited to: (a) Bathing and completing personal hygiene routines; (b) Dressing and changing clothes; (c) Eating; (d) Toileting, including: (i) Bladder and bowel requirements; (ii) Routines associated with the achievement or maintenance of continence; and (iii) Incontinence care; (e) Mobility, including: (i) Transferring from a bed, chair, or other structure; (ii) Moving, turning, and positioning the body while in bed or in a wheelchair; and (iii) Moving about indoors or outdoors. (2) “Area agency” has the meaning stated in Human Services Article, §10-101(b), Annotated Code of Maryland. (3) “Assisted living services provider” means a provider licensed by the Department in accordance with COMAR 10.07.14. (4) “Case management” means services which assist an applicant or a participant in gaining access to the waiver services covered under this chapter, as well as to other services under the Medical Assistance Program. (5) “Case manager” means an individual performing case management services under a waiver program. (6) Community Setting. (a) “Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to: (i) Seek employment and work in competitive integrated settings; (ii) Engage in community life; (iii) Control personal resources; and (iv) Receive services. (b) “Community setting” does not mean: (i) Hospitals; (ii) Nursing facilities; (iii) Institutions for mental diseases; (iv) Intermediate care facilities for individuals with intellectual disabilities; (v) Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; (vi) Prisons; (vii) Residential treatment centers; or (viii) Any establishment that furnishes food, shelter, and some treatment or services to four or more persons unrelated to the proprietor. (7) “Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department. (8) “Family member” means an adult who: (a) Lives with or provides care to the participant; and (b) Is not paid to provide the care. (9) “Home” means the participant's place of residence in a community setting. (10) “Home and Community-Based Options Waiver” means the program implemented under this chapter in accordance with the document for this waiver and any amendments to it submitted by the Department and approved by the Secretary of Health and Human Services, which authorizes the waiver of certain specified statutory requirements limiting coverage for home and community-based services under the Maryland Medical Assistance Program. (11) “Instrumental activities of daily living” means tasks or activities that include, but are not limited to: (a) Preparing meals; (b) Performing light chores that are incidental to the personal assistance services provided to the participant; (c) Shopping for groceries; (d) Nutritional planning; (e) Traveling as needed; (f) Managing finances and handling money; (g) Using the telephone or other appropriate means of communication; (h) Reading; and (i) Planning and making decisions. (12) “Maryland Department of Aging” has the meaning stated in Human Services Article, Title 10, Annotated Code of Maryland. (13) “Medicaid” means the Medical Assistance Program. (14) “Medical Assistance Program” means the Program administered by Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients. (15) “Medical day care” means a program of medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults who, due to their degree of impairment, need health maintenance and restorative services supportive to their community living in accordance with COMAR 10.09.07. (16) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventative, curative, ameliorative, palliative or rehabilitative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, the participant's family, or the provider. (17) “Nursing facility” means a facility which is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10. (18) “Participant” means an individual who: (a) Has been determined to meet the qualifications for participation in the waiver as specified in Regulation .03 of this chapter; and (b) Is enrolled with the Department to receive Medicaid services. (19) “Person-centered” means that the plan reflects what is important to the individual, what is important for his or her health and welfare, and is developed with input from the individual and the individual's representative when applicable. (20) “Plan of service” means the written, person-centered support plan developed by the applicant or participant with support from the case manager and the individual's representative, when applicable. (21) “Principal” means a person who: (a) Has a direct or indirect ownership or control interest of 5 percent or more in the provider; (b) Is an officer, director, agent, or managing employee of the entity; or (c) Was described in §B(20)(a) of this regulation, but is no longer so described because of a transfer of ownership or control interest to an immediate family member or a member of the household of the person who continues to maintain an interest described in §B(20)(a) of this regulation. (22) “Program” means the Medical Assistance Program. (23) “Provider” has the same meaning stated in COMAR 10.09.36. (24) “Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter. (25) “Recipient” means an individual who is certified by the Department as eligible for, and is receiving, Medical Assistance benefits. (26) “Reportable event ” means an allegation of, or an actual occurrence of, an incident that may pose an immediate or serious risk, or has potential to adversely affect the physical or mental health, safety, or well-being of a waiver applicant or participant, or complaints regarding administrative service or quality of care issues. (27) “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in or associated with an individual's place of residence. (28) “State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements. (29) “Telehealth” has the meaning stated in COMAR 10.09.49.02. (30) “Waiver applicant” means an individual who is applying for participation in the waiver, to receive the services covered under this chapter. (31) “Waiver” means the Home and Community-Based Options Waiver as implemented through this chapter. #### Regulation .02 Licensing and Certification Requirements. *COMAR 10.09.54.02* A. Assisted living services providers shall be licensed by the Department in accordance with COMAR 10.07.14. B. The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered: (1) Physicians; (2) Registered nurses; (3) Licensed practical nurses; (4) Occupational therapists; (5) Physical therapists; (6) Dietitians; (7) Nutritionists; (8) Social workers; and (9) Psychologists. C. The following shall be appropriately licensed, certified, or approved by the Department to provide services under this chapter: (1) Licensed home health agency under COMAR 10.09.04; (2) Certified residential services agency under COMAR 10.07.05; (3) Nursing facility under COMAR 10.07.02; and (4) Medical day care center under COMAR 10.09.07. #### Regulation .03 Participant Eligibility. *COMAR 10.09.54.03* A. General Requirements. (1) To be eligible for participation, an individual shall be determined by the Department to meet the conditions of §§B—E of this regulation. (2) Eligibility for waiver services shall be reevaluated every 12 months or more frequently if needed due to a significant change in the participant’s condition, needs, or financial status. B. Technical Eligibility. To be eligible for services covered under this chapter, an applicant or participant shall be determined by the Department to meet the technical eligibility criteria if the individual: (1) Has been determined by the Department to need a nursing facility level of care; (2) Is at least 18 years old; (3) Is not simultaneously enrolled for services covered under: (a) Another Medicaid waiver program under the authority of §1915(c) of the Social Security Act; or (b) The Program of All-Inclusive Care for the Elderly (PACE); (4) Has an active plan of service that: (a) Is based on: (i) The assessment and recommended plan of care; and (ii) Consultation with the applicant or participant; (b) Addresses the applicant’s or participant’s needs; (c) Specifies the names of service providers; (d) Is cost neutral, which is determined by adding annualized costs of services covered under this chapter and any other State Plan services which are not covered for nursing facility residents, and ensuring that the resulting amount is not more than 125 percent of the Program's average per capita-annualized-net payments for nursing facility services. Any assessed participant contributions will not be considered in determining cost neutrality; and (e) Includes the signature of the participant, the individual’s representative if applicable, and the case manager listed within the plan of service; (5) Is offered the choice between waiver services and nursing facility services; (6) Chooses to receive waiver services; (7) Resides in a home, as defined under Regulation .02B of this chapter; and (8) Uses at least one waiver service within a 12-month period. C. Medical Assistance Eligibility. (1) An individual is not eligible to receive waiver services during a penalty period imposed under COMAR 10.09.24.08-1 or 10.09.24.08-2 due to disposal of assets. (2) All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to waiver applicants and participants, with the following exceptions: (a) COMAR 10.09.24.04J(1)—(3); (b) COMAR 10.09.24.06B(2)(a)(ii); (c) COMAR 10.09.24.08G; (d) COMAR 10.09.24.10C; (e) COMAR 10.09.24.10D(4)—(6); (f) COMAR 10.09.24.10-1C(3)(a); and (g) COMAR 10.09.24.15A-2(2). D. Cost of Care. (1) For a participant whose home is an assisted living facility, the Department shall reduce its monthly payment for assisted living services by the amount remaining after deducting from the individual's total nonexcluded monthly income the following amounts in the following order: (a) A personal needs allowance, consisting of the amount established in accordance with COMAR 10.09.24.10D(2)(c) and the assisted living provider's charge, not exceeding $420 per month, for room and board; (b) A spousal or family maintenance allowance, or both, if applicable, in accordance with COMAR 10.09.24.10-1C(3)(b) and (c); and (c) Incurred medical expenses in accordance with COMAR 10.09.24.10D(2)(f)—(h). (2) The Department shall determine the amount of available income to be paid by a participant towards the cost of assisted living services. (3) The participant shall pay the amount of available income for the participant’s cost of care, and the assisted living provider’s monthly charge for room and board, directly to the assisted living services provider. E. Waiver Eligibility. Based on the criteria established in §§A—C of this regulation an applicant's eligibility for services under this chapter shall be established by the Department based on the following policies for the effective date of waiver eligibility: (1) No retroactive eligibility; and (2) Waiver eligibility may not begin before the latest of the following five dates: (a) Waiver application date; (b) Effective date of medical certification for the waiver's institutional level of care; (c) Date that the applicant's written waiver plan of service is established, which shall include at least one waiver service and may be a provisional plan for not more than the first 60 days of waiver enrollment; (d) Date that the applicant or representative signed a form designated by the Department to indicate the choice of waiver services as an alternative to institutionalization; and (e) Date of the applicant's discharge from institutionalization in a long term care facility, if applicable. F. Annual Cap and Registry for Waiver Participation. (1) The Department shall establish an annual cap, approved by the federal Centers for Medicare and Medicaid Services (CMS), for the number of unduplicated individuals who may receive the services covered under this chapter, based on available State and federal funding. (2) Eligible individuals shall be enrolled in the waiver on a first-come, first-served basis until the annual cap on waiver participation is reached. (3) Once the annual cap on waiver participation is reached: (a) A registry list shall be established for individuals interested in applying for waiver services; (b) Individuals on the registry shall have an opportunity to apply for the waiver in accordance with procedures established by the Department; and (c) The Department and CMS may authorize increasing the waiver cap if the Department determines that sufficient Program funds are available to reimburse the services recommended in the individual's plan of service and the participant's other Program services for the remainder of the State fiscal year. (4) Individuals in nursing facilities who are receiving Medicaid services for at least 30 days may apply directly for the waiver without being put on the registry list. G. Termination of Participation. (1) A participant shall be terminated from participation in the waiver if the participant: (a) No longer meets the eligibility requirements specified in §§B—E of this regulation; (b) Voluntarily chooses, or the participant’s authorized representative chooses on the participant’s behalf, to disenroll from the waiver program; (c) Moves to another state; (d) Is an inpatient for 30 consecutive days or more in a hospital or nursing facility; or (e) Dies. (2) If an individual is terminated from the waiver, the same individual may re-enter the waiver during the same waiver year, or within 90 days of termination contingent on waiver capacity, provided that the individual meets all of the eligibility requirements of the waiver. #### Regulation .04 Conditions for Provider Participation — General Requirements. *COMAR 10.09.54.04* A. To participate as a provider of a service covered under this chapter a provider shall: (1) Meet all of the conditions for participation as a Maryland Medical Assistance Program provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; (2) Verify the qualifications of all individuals who render services on the provider's behalf, and provide a copy of the current license or credentials upon request; (3) Implement the reporting and follow-up of incidents and complaints in accordance with the Department's established reportable events policy; (4) Agree to cooperate with required inspections, reviews, and audits by authorized governmental representatives; (5) Agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter for only those services covered under this chapter which have been: (a) Pre-approved in the participant's plan of service; (b) Provided in a manner consistent with the participant's plan of service; and (c) Identified in the provider agreement as within the scope of the provider's Medicaid participation; (6) Agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years, in a manner approved by the Department; (7) Agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and with consultation and agreement by the participant or a participant's representative when applicable; (8) Submit a transition plan to the case manager and participant or participant's representative when applicable when suspending or terminating services; (9) Verify Medicaid eligibility at the beginning of each month that services will be rendered; (10) Not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; (11) Notify the Department in writing at least 45 days in advance of any: (a) Voluntary closure; (b) Change of ownership; (c) Change of location; (d) Sale of the business; (e) Change in the name under which the provider is doing business; or (f) Change in provider tax identification number; (12) Include in the notice to the Department regarding any change of status under §A(11) of this regulation, the method for informing waiver participants and representatives of its intent to close, change ownership, change location, or sell its business; (13) Apply for a new license if applicable, whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of waiver services; (14) Submit a Medicaid provider application to the Department if the new owner chooses to participate in the waiver program; (15) Obtain a state and federal background check through the Criminal Justice Information System on all staff in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland; (16) Render services in person, except as expressly authorized by the Department in the regulation governing that service type; and (17) If rendering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: (1) Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services; (2) Undergone the imposition of sanctions under COMAR 10.09.36.08; (3) Been subject to disciplinary action, including actions by the licensing board, that indicate behavior which is potentially harmful to participants; (4) Been cited by a State agency for deficiencies which affect participants health and safety; or (5) Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to: (a) Failure to meet contractual obligations; or (b) Fraudulent billing practices. C. A provider who renders health-related services to participants shall agree to: (1) Periodically indicate the condition of a participant in accordance with the procedures and forms designated by the Department; and (2) Share and discuss the documented information at the request of the participant. D. A provider, its principals, or its staff may not have a history of behavior or convictions that could be harmful to participants, as evidenced through a State and federal background check conducted in accordance with §A(15) of this regulation. #### Regulation .05 Specific Conditions for Provider Participation — Assisted Living. *COMAR 10.09.54.05* A. To participate in the program as a provider of assisted living services under this chapter a provider shall: (1) Be licensed by the Department at the time that services are rendered, in accordance with COMAR 10.07.14, to provide assisted living services; (2) Be or employ a manager who is qualified as: (a) A licensed physician; (b) A licensed registered nurse; (c) A licensed practical nurse; or (d) An individual with at least 3 years’ experience in direct patient care in a private home, certified home, or health-related facility; (3) Employ an alternate assisted living manager who meets the requirements as specified in §A(2) of this regulation. (4) Have at least one staff person per eight residents on duty at all times during daytime hours, and have a staff-to-resident ratio at night which is adequate to provide the required services and maintain the facility in a safe and orderly condition, with additional staffing if required by the Department depending on residents' functional levels; (5) Participate in training on the waiver billing process and other waiver requirements, as specified by the Department; (6) Have the appropriate insurance coverage to cover the provider and its employees and vehicles if the provider chooses to transport participants to medical, social, recreational, and other services; (7) Cooperate with other service providers and quality assurance monitors by: (a) Facilitating on-site visits of authorized quality assurance monitors to review compliance with waiver and regulatory requirements; (b) Facilitating a case manager's on-site visits to the facility, which shall occur at least quarterly, to review the facility, regulatory compliance, service provision, and participants' status and needs; (c) Communicating with a participant's case manager concerning the participant's status, needs, and service provision; (d) Informing the case manager within 1 working day of any significant change in the participant's status and service needs; (e) Facilitating, as necessary and appropriate, the delivery of authorized waiver and State Plan services in the plan of service; and (f) Facilitating waiver participant's relocation to comparable housing, if necessary, including transfer of all personal belongings and financial arrangements; and (8) Submit claims consistent with the provisions of Regulation .22 of this chapter. B. Bed Reservations. If bed reservations are offered to participants who are absent from an assisted living facility, the bed reservations policy shall: (1) Be provided to all residents and, where appropriate, the resident's representative, at admission; (2) Be fairly and consistently applied to all residents; (3) Specify that the bed reservation service is not a Medicaid covered service; (4) Clearly state that it is the resident's decision whether to reserve the bed; and (5) Specify that the charges to participants for bed reservation days may not exceed the full Medicaid waiver per diem rate. C. An assisted living provider may limit waiver participation to a designated unit or units only if approved by Department and the facility resident agreement contains the following provisions: (1) The facility's participation in the Program is limited to one or more designated units and, in order to access Medicaid waiver benefits, the resident shall reside in a designated unit; (2) A resident of a designated unit has a right to apply for the waiver at any time and access waiver benefits without restrictions by the provider when the resident is found eligible by the Program; and (3) A resident not in a designated unit who is otherwise eligible or seeking eligibility for the waiver shall be given first consideration and, with all other factors equal, first priority in admission to a vacant bed in a designated unit. #### Regulation .06 Specific Conditions for Provider Participation — Behavior Consultation. *COMAR 10.09.54.06* To participate in the program as a provider of behavior consultation services under this chapter a provider shall: A. Be: (1) A health services agency that: (a) Employs a qualified individual or individuals to render behavior consultation services; and (b) Assures supervision of the individual rendering behavior consultation services by a licensed mental health professional or by a bachelor's level nurse with 4 years of experience or with an appropriate graduate degree; or (2) An individual who is: (a) Qualified to render behavior consultation services; and (b) Licensed to practice independently; B. Assure that the individual who renders behavior consultation services: (1) Is a licensed: (a) Registered nurse; (b) Psychologist; or (c) Clinical social worker; and (2) Has: (a) Direct experience working with adults with behavioral problems; and (b) Demonstrated ability to perform assessments; and C. Assure response within 24 hours to a referral from a participant's case manager for behavior consultation services. #### Regulation .07 Specific Conditions for Provider Participation — Senior Center Plus. *COMAR 10.09.54.07* To participate in the program as a provider of Senior Center Plus services under this chapter a provider shall: A. Be approved and monitored by the Maryland Department of Aging as a nutrition service provider; B. Meet all local and State requirements to operate as a nutrition site, which include but are not limited to inspection and approval of the facility by the local fire marshal, periodic fire drills, and inspection and approval by the local sanitarian to assure compliance with health department requirements for food service facilities; C. Assure that the facility provides an accessible environment, in compliance with the Americans with Disabilities Act (ADA), 28 CFR Part 36; D. Maintain adequate records on participants, including progress notes and outcomes; E. Provide at least one staff person per eight clients, with additional staffing if required by the Maryland Department of Aging depending on participants' functional levels; F. Employ as the center's manager or in another staff position an individual who: (1) Is a licensed health professional or a licensed social worker; (2) Has at least 3 years’ experience in direct patient care at an adult day care center, nursing facility, or health-related facility; and (3) Participates in training specified and approved by the Maryland Department of Aging; G. Provide Senior Center Plus services to participants at least 4 hours a day, 1 or more days a week on a regularly scheduled basis, in an out-of-home, outpatient setting; H. Serve at least one nutritional meal per day that: (1) Is prepared in a licensed food service establishment; (2) Meets at least 1/3 of the daily recommended dietary allowance; and (3) Does not constitute a full nutritional regimen of three meals per day; I. Serve snacks, as desired by the participants, when the day program exceeds 6 hours; and J. Have menus reviewed and approved quarterly by a registered dietitian for nutritional adequacy. #### Regulation .08 Specific Conditions for Provider Participation — Family Training. *COMAR 10.09.54.08* To participate in the Program as a provider of family training under this chapter a provider shall: A. Be a self-employed trainer or an agency that employs qualified trainers in accordance with §§B—D of this regulation; B. Have demonstrated experience with the skill being taught; C. Be willing to meet at the participant's home to provide services; and D. Employ licensed registered nurses, occupational therapists, physical therapists, or social workers who are appropriately experienced and licensed to provide the needed training. #### Regulation .09 Specific Conditions for Provider Participation — Dietitian and Nutritionist Services. *COMAR 10.09.54.09* To participate in the program as a provider of dietitian and nutritionist services under this chapter a provider shall be a: A. Dietitian or nutritionist who is licensed in accordance with COMAR 10.56.01 and Health Occupations Article, Title 5, Annotated Code of Maryland; or B. Professional group or agency which employs an individual who is licensed in accordance with §A of this regulation. #### Regulation .10 Specific Conditions for Provider Participation — Medical Day Care Services. *COMAR 10.09.54.10* To participate in the program as a provider of medical day care services under this chapter a provider shall: A. Meet the licensure requirements as provided in COMAR 10.12.04; and B. Meet the requirements of COMAR 10.09.07. #### Regulation .10-1 Specific Conditions for Participation — Respite Care. *COMAR 10.09.54.10-1* To participate in the Program as a provider of respite care services under Regulation .18-1 of this chapter a provider shall be enrolled as a provider of: A. Assisted living services under this chapter; or B. Nursing facility services under COMAR 10.09.10. #### Regulation .11 Specific Conditions for Provider Participation — Case Management Services. *COMAR 10.09.54.11* To participate in the program as a provider of case management services under this chapter a provider shall: A. Be an area agency or other entity designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act; and B. Agree to be monitored by the Department. #### Regulation .12 Covered Services — General. *COMAR 10.09.54.12* The Program shall reimburse for the services specified in Regulations .13—.19 of this chapter when, pursuant to the requirements of this chapter, these services have been pre-approved by the Department in the participant’s plan of service, and billed in accordance with the payment procedures in Regulation .22 of this chapter. #### Regulation .13 Covered Services — Assisted Living Services. *COMAR 10.09.54.13* A. Assisted living services shall include the provision of: (1) A structured, supportive environment in a home-like setting; (2) Personal assistance and chore services including: (a) Assisting the participant, as necessary, with performing activities of daily living and instrumental activities of daily living, including cuing the participant to perform these activities; (b) Routine housekeeping, laundry, household care, and chore services needed to maintain the facility as a clean, sanitary, and safe environment; and (c) Menu planning, food shopping, and meal preparation and serving; (3) Basic personal hygiene supplies, including but not limited to: (a) Soap; (b) Bathroom tissue; (c) Paper towels; (d) Toothpaste; (e) Toothbrush; and (f) Shampoo; (4) 24-hour supervision of participants to assure health and safety; (5) Assistance with medication administration, in accordance with COMAR 10.27.11 and COMAR 10.07.14; (6) Recreational and social activities of a nontherapeutic and nonhabilitative nature which are confined to the assisted living facility and are for the purpose of socialization; (7) Reminding the participant of medical appointments; (8) Assistance with transportation arrangements to needed services; (9) Conferring with the participant's case manager about the participant's status and service needs, as necessary; (10) Assisting the participant in accessing needed medical or mental health services in emergency situations; and (11) Other services specified for assisted living programs in COMAR 10.07.14. B. The living environment and service provision shall reflect participants' individualized needs and preferences. C. Assisted living services reimbursed under this chapter may not include room and board. #### Regulation .14 Covered Services — Behavior Consultation Services. *COMAR 10.09.54.14* A. A provider may bill for the length of a home visit to a participant, upon completion of the services specified in §C of this regulation. B. Behavior consultation services may be preauthorized by a participant's plan of service when: (1) A participant or the participant's representative request the service due to an identified behavioral issue; or (2) The participant's behavior is: (a) Potentially dangerous to the participant's or another person's health and functioning; or (b) Placing the participant at risk of institutionalization due to health and safety concerns. C. Behavior consultation services include a: (1) Home visit by an individual qualified to render services to: (a) Evaluate a participant's behavior; (b) Assess the situation; (c) Determine the contributing factors; and (d) Recommend interventions and treatments; and (2) Written report with the results of the provider’s assessment and recommendations, which shall be reviewed verbally by the participant, the participant’s representative and family when applicable, and the participant’s case manager and caregivers, which may include an assisted living provider, to discuss: (a) The report's findings and recommendations; and (b) A course of action, including any related needed medical interventions. D. Behavior consultation services do not include: (1) The time spent on related activities before or after the home visit; or (2) The provider's time spent on any supervisory or consultative services provided to the renderer of services. E. The initial assessment provided in §C of this regulation to evaluate a participant's behavior, assess the situation, and determine the contributing factors shall be performed in person. F. The verbal review described in §C(2) of this regulation may be delivered via telehealth if recommendations do not require hands-on training or intervention. G. Except as provided in §§E and F of this regulation, behavior consultation services may be rendered via telehealth. #### Regulation .15 Covered Services — Senior Center Plus. *COMAR 10.09.54.15* A. A day of service is covered by the Program when the participant attends for at least 4 hours, not including transportation to and from the center. B. Senior Center Plus services include a program of structured group recreational activities, supervised care, assistance with activities of daily living and instrumental activities of daily living, and enhanced socialization provided in an out-of-home, outpatient setting. Social and recreational activities designed for elderly, disabled individuals, as well as one nutritious meal shall be available at the center. C. This program is designed to promote the participants' optimal functioning and to have a positive impact on the participants' orientation and cognitive ability. D. A provider may choose to provide transportation to and from the site of the Senior Center Plus services. These transportation services may: (1) Not be included in the provider's daily rate negotiated with the Maryland Department of Aging; and (2) Be reimbursed through some other funding source for transportation services. E. This service does not cover: (1) Transportation; (2) Direct health care; or (3) A full regimen of three meals per day. #### Regulation .16 Covered Services — Family Training. *COMAR 10.09.54.16* A. The Program covers family training when the service is approved in the plan of service and rendered to a family member by a qualified provider, not including the time spent planning, preparing, setting up or following up after the training. B. The training and counseling services may not include services rendered: (1) On a group basis or in a classroom setting; or (2) To a family member of a participant residing in a licensed assisted living facility. C. The topics covered by the training and counseling services shall be: (1) Targeted to the individualized needs of the family member receiving the training, as related to the participant's needs; (2) Sensitive to the educational background, culture, and general environment of the participant or family member receiving the training; and (3) Specified in the plan of service as necessary to: (a) Ensure the participant's health and safety; and (b) Prevent the participant's institutionalization. D. The training and counseling services may include: (1) Instruction on treatment regimens and dementia; (2) Use of equipment specified in the plan of service; (3) Other issues; or (4) Follow-up training as authorized. E. The initial assessment for training and counseling following a rehabilitative or hospital stay shall be performed in person. F. If family members are unable to participate fully in the service when delivered via telehealth, the provider shall perform the service in person. G. Except as provided in §§E and F of this regulation, family training services may be rendered via telehealth. #### Regulation .17 Covered Services — Dietitian and Nutritionist Services. *COMAR 10.09.54.17* A. Dietitian and nutritionist services shall include: (1) The provision of nutrition care plan outcomes and approaches; (2) Nutrition care planning, nutrition assessment, and dietetic instruction; and (3) Services within the scope of practice of the nutritionist's or dietitian's license, as defined by: (a) Health Occupations Article, Title V, Annotated Code of Maryland; and (b) Regulations under COMAR 10.56 for the Board of Dietetic Practice. B. Dietitian and nutritionist services may not include services rendered: (1) On a group basis or in a classroom setting; or (2) To participants residing in a licensed assisted living facility. C. The services shall be: (1) Covered if the participant's medical condition requires the judgment, knowledge, and skills of a licensed nutritionist or licensed dietitian; (2) Targeted to the individualized needs of the participant, rather than being of general interest; (3) Sensitive to the educational background, culture, religion, eating habits and preferences, and general environment of the participant; and (4) Specified in the participant's plan of service as necessary to: (a) Ensure the participant's health and safety; and (b) Prevent the participant's institutionalization or hospitalization. D. The initial assessment and counseling following a rehabilitative or hospital stay shall be performed in person. E. If family members are unable to participate fully in the service when delivered via telehealth, the provider shall perform the service in person. F. Except as provided in §§D and E of this regulation, dietitian and nutrition services may be rendered via telehealth. #### Regulation .18 Covered Services — Medical Day Care Services. *COMAR 10.09.54.18* A provider shall render medical day care services in accordance with COMAR 10.09.07. #### Regulation .18-1 Covered Services — Respite Care. *COMAR 10.09.54.18-1* Respite care services shall: A. Be provided to participants who, due to physical or cognitive impairments, are unable to care for themselves; B. Be furnished on a short-term basis because of the absence or need for relief of an individual normally providing the care; C. Provide a period of rest and renewal, which contributes to maintaining the participant at home in the community; D. Be provided at planned intervals, in a time of crisis, or as needed; E. Include the participant's room and board; F. Include overnight care; and G. Including the following services: (1) Supervising participants with cognitive impairments to ensure the individual’s health and safety; (2) Assisting participants with functional impairments to perform activities of daily living or instrumental activities of daily living; and (3) Delegated nursing functions, such as medication assistance or administration by appropriately trained, certified, and supervised staff. #### Regulation .19 Covered Services — Case Management Services. *COMAR 10.09.54.19* A. Case management services shall be targeted to address the individualized needs of the participant and be sensitive to the educational background, culture, and general environment of the participant. B. Case management services include time spent by a qualified provider conducting any of the following activities: (1) Assisting with the initial or annual waiver eligibility process; (2) Assisting with the application and supporting the individual in maintaining all public and private benefits, resources, and entitlements; (3) Conducting an assessment of needs, and developing a person-centered plan of service, to include all services needed to live safely in the community; (4) Assisting the participant with referrals, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to: (a) Behavioral health; (b) Educational services; (c) Disposable medical supplies and durable medical equipment; (d) Housing; (e) Medical services; and (f) Social services; (5) Monitoring the provision of services to determine if services are received in accordance with the plan of services; (6) Facilitating referrals to other programs if the individual is denied waiver services; and (7) Using information technology systems developed by the Department. #### Regulation .20 Conditions for Reimbursement. *COMAR 10.09.54.20* The Program shall reimburse for the services specified in Regulations .13—.19 of this chapter, if provided in accordance with the requirements of this chapter and if the service: A. Is recommended on the participant’s plan of service as necessary in order to: (1) Prevent the applicant’s or participant’s admission to an institution; or (2) Assure the health and safety of an applicant or participant in the community; B. Has been pre-approved by the Department in the participant’s plan of service; C. Is provided to an enrolled participant; D. Is medically necessary; E. Is provided by a Medicaid provider who meets the conditions for participation under this chapter; and F. Is cost-neutral for the Program, which is determined by adding annualized costs of services covered under this chapter and any other State Plan services which are not covered for nursing facility residents, and ensuring that the resulting amount is not more than: (1) 125 percent of the Program's average per capita-annualized-net payments for nursing facility services for a waiver participant in accordance with the provisions of Regulation .03B(4)(d) of this chapter; and (2) In the aggregate for all waiver participants, 100 percent of the Program’s average per capita-annualized-net payments for nursing facility services. #### Regulation .21 Limitations. *COMAR 10.09.54.21* A. Reimbursement may be made by the Program only when the requirements of this chapter are met. B. The Program may not reimburse the following combinations of services for a participant for the same date of service: (1) Senior Center Plus and Medical Day Care under this chapter; (2) Assisted living services under this chapter and personal assistance services under COMAR 10.09.20 or COMAR 10.09.84; (3) Assisted living services and respite care under this chapter; or (4) Respite care under this chapter and personal assistance services covered under COMAR 10.09.20 or COMAR 10.09.84. C. Reimbursement by the Program for respite care shall be limited to 14 days per occurrence. #### Regulation .22 Payment Procedures. *COMAR 10.09.54.22* A. To receive payment as a provider of services covered under Regulations .13—.19 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department's billing manual. B. Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06. C. Payments. (1) Payments shall be made directly to a qualified provider. (2) A provider shall be paid the lesser of: (a) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rates established in §D of this regulation. D. Rates. (1) For dates of service beginning July 1, 2022, through June 30, 2024, fees per unit of service shall be as follows: (a) Assisted Living Level II, No Medical Day Care: reimbursed at the maximum rate of $81.57 per day; (b) Assisted Living Level III, No Medical Day Care: reimbursed at the maximum rate of $102.94 per day; (c) Assisted Living Level II, Medical Day Care: reimbursed at the maximum rate of $61.21 per day; (d) Assisted Living Level III, Medical Day Care: reimbursed at the maximum rate of $77.18 per day; (e) Behavioral Consultation: reimbursed at the maximum rate of $89.22 per hour; (f) Case Management — Administrative: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit; (g) Case Management — Comprehensive: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit; (h) Case Management — Ongoing: reimbursed at the maximum rate of $83.66 per hour or $20.9138 per 15-minute unit; (i) Dietitian and Nutritionist Services: reimbursed at the maximum rate of $89.22 per hour; (j) Family 1/1 Training: reimbursed at the maximum rate of $89.22 per hour; (k) Medical Day Care Services: reimbursed at the maximum rate of $104.81 per day; and (l) Senior Center Plus: reimbursed at the maximum rate of $64.90 per day. (2) For dates of service beginning July 1, 2024, fees per unit of service shall be as follows: (a) Assisted Living Level II, No Medical Day Care: reimbursed at the maximum rate of $90.74 per day; (b) Assisted Living Level III, No Medical Day Care: reimbursed at the maximum rate of $114.51 per day; (c) Assisted Living Level II, Medical Day Care: reimbursed at the maximum rate of $68.09 per day; (d) Assisted Living Level III, Medical Day Care: reimbursed at the maximum rate of $85.86 per day; (e) Behavioral Consultation: reimbursed at the maximum rate of $99.25 per hour; (f) Case Management — Administrative: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; (g) Case Management — Comprehensive: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; (h) Case Management — Ongoing: reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; (i) Dietitian and Nutritionist Services: reimbursed at the maximum rate of $99.25 per hour; (j) Family 1/1 Training: reimbursed at the maximum rate of $99.25 per hour; (k) Medical Day Care Services: reimbursed at the maximum rate of $116.59 per day; and (l) Senior Center Plus: reimbursed at the maximum rate of $72.19 per day. (3) The Program’s rates for covered services under Regulations .13—.19 of this chapter shall be adjusted subject to the limitations of the State budget. #### Regulation .23 Recovery and Reimbursement. *COMAR 10.09.54.23* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .24 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.54.24* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .25 Appeal Procedures. *COMAR 10.09.54.25* Appeal procedures are those set forth in COMAR 10.09.36.09. #### Regulation .26 Interpretive Regulation. *COMAR 10.09.54.26* State regulations are interpreted as set forth in COMAR 10.09.36.10. #### Regulation .27 Implementation Date. *COMAR 10.09.54.27* This chapter shall be implemented January 6, 2014. ### Chapter 55 — Physician Assistants **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: May 11, 2015 (42:9 Md. R. 647) **Administrative History:** Regulation .03A amended effective July 10, 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .06 amended effective September 26, 2016 (43:19 Md. R. 1072) **Administrative History:** Regulation .06G amended effective July 10, 2023 (50:13 Md. R. 512) #### Regulation .01 Definitions. *COMAR 10.09.55.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advanced duties” means medical acts that require training and certification beyond the basic physician assistant education program. (2) “Board” means the State Board of Physicians. (3) “Delegation agreement” means a document that is executed by a licensed physician and a physician assistant containing the requirements of Health Occupation Article, §15-302, Annotated Code of Maryland, and COMAR 10.32.03.05. (4) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Dispense” means to dispense starter dosages or drug samples. (6) “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (7) “Modification” means any change to the delegation agreement that governs the physician assistant’s performance of duties, including but not limited to practice location, scope of practice, change of supervising physician (primary or alternate), and prescriptive authority. (8) “Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02. (9) “Physician assistant” means an individual who is licensed to practice medicine with physician supervision. (10) “Practice as a physician assistant” means the performance of medical acts that are: (a) Delegated by a supervising physician to a physician assistant; (b) Within the supervising physician’s scope of practice; and (c) Appropriate to the physician assistant’s education, training, and experience. (11) “Program” means the Maryland Medical Assistance Program. (12) “Provider” means a licensed physician assistant who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider number. (13) “Participant” means a person who is certified as eligible for, and is receiving, Medical Assistance benefits. (14) "Supervision” means the responsibility of the physician to exercise on-site supervision or to be able to provide immediate available direction for the physician assistants performing delegated medical acts, and includes: (a) Oversight of the physician assistant and acceptance of direct responsibility for the patient services and care rendered by the physician assistant; (b) Continuous availability to the physician assistant either in person, by telephone, by electronic means, or by some other form of telecommunication; and (c) Designation of one or more alternate supervising physicians. #### Regulation .02 License and Certification Requirements. *COMAR 10.09.55.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. A physician assistant applying for provider status shall: (1) Be licensed to practice as a physician assistant in Maryland or in the state or jurisdiction in which the service is provided; (2) Be in compliance with requirements set forth in COMAR 10.32.03; (3) If practicing in Maryland, have a delegation agreement with a supervising physician that outlines the physician assistant’s duties within the medical practice or facility which has been filed with and approved by the Board of Physicians; and (4) If practicing in Maryland, have a delegation agreement with a supervising physician that documents the specialized training, education, and experience of the physician assistant for performing advanced duties. C. A physician having a written agreement to supervise a physician assistant shall: (1) Be licensed to practice medicine in the state in which the physician assistant is providing services; (2) Delegate only medical acts that are within the scope of the practice of the physician and are suitable to be performed by the physician assistant, taking into account the physician assistant’s education, training, and level of competence; (3) Accept Program reimbursement as payment in full for services provided; (4) Establish and review drug and other medical guidelines with the physician assistant; (5) Participate with the physician assistant in reviewing and discussing medical diagnoses and the therapeutic and corrective measures employed in the practice setting; (6) Be available for consultation in person, by telephone, electronic means, or by some other form of telecommunication; and (7) Designate an alternate supervising physician if the physician identified in the delegation agreement temporarily becomes unavailable. D. For hospitals, correctional facilities, detention centers, or public health facilities, the primary supervising physician shall keep an ongoing list of all approved alternate supervising physicians within the alternate supervising physicians’ scopes of practice, with each alternate supervising physician’s signature and date. #### Regulation .03 Conditions for Participation. *COMAR 10.09.55.03* A. A physician assistant shall: (1) Meet all general provider requirements set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. A physician assistant shall: (1) Have a written and executed delegation agreement with a licensed physician approved by the Board, or as required by the state in which services are provided; and (2) If the primary supervising physician delegates the prescribing of controlled dangerous substances to a physician assistant, if required by applicable law, the physician assistant shall: (a) Obtain a Maryland Controlled Dangerous Substance (MCDS) license from the Maryland Division of Drug Control; and (b) After obtaining an MCDS license: (i) Register with the Drug Enforcement Administration (DEA); and (ii) Obtain a license from the DEA. C. To participate as a provider, the physician assistant shall submit to the Program a copy of the provider's: (1) Current approved delegation agreement; and (2) Current license to practice in the state in which services are provided. D. Modification of Delegation Agreement. (1) If the provider's approved written delegation agreement with the physician is modified or terminated by either party, the physician assistant and supervising physician shall notify the Program within 5 days in writing. (2) If the delegation agreement is modified, the physician assistant and the supervising physician shall submit to the Program a copy of the modified or new written agreement. (3) If the duties of the physician assistant are limited, reduced, or result in other changes of employment that might be grounds for disciplinary actions under Health Occupations Article, §15-314, Annotated Code of Maryland, the supervising physician, hospital, alternative health care system, or employer shall notify the Program immediately or within 5 days in writing. E. A physician assistant may practice in Maryland: (1) Only in accordance with the delegation agreement approved by the Board; or (2) If out-of-State, only in accordance with the scope of practice allowed by the licensing authority in the state in which services are provided. #### Regulation .04 Covered Services. *COMAR 10.09.55.04* A. The Program covers medically necessary services rendered to participants in accordance with: (1) The functions allowed under: (a) The Physician Assistant’s Practice Act; (b) COMAR 10.32.03; and (c) The physician assistant’s written delegation agreement with a physician; or (2) If out-of-State, those functions authorized in the state in which the services are provided. B. The services in §A of this regulation shall be described in the participant's medical record in sufficient detail to support the invoice submitted for those services. #### Regulation .05 Limitations. *COMAR 10.09.55.05* The Program does not cover the following under these regulations: A. Services not encompassed by the physician assistant’s written delegation agreement with the physician, if required by the state in which services are provided; B. Services not medically necessary; C. Services prohibited by the Board; D. Services prohibited in the state in which services are provided; E. Physician assistant services included as part of the cost of an inpatient facility, hospital outpatient department, or freestanding clinic; F. Visits by or to the physician assistant solely for the purpose of the following: (1) Prescription, drug, or food supplement pickup; (2) Recording of an electrocardiogram; (3) Ascertaining the patient's weight; (4) Interpretation of laboratory tests or panels; or (5) Prescribing or administering oral medications; G. Drugs and supplies which are acquired by the licensed and certified physician assistant at no cost; H. Injections and visits solely for the administration of injections, unless medical necessity and the patient's inability to take appropriate oral medications are documented in the patient's medical record; I. More than one visit per day per participant unless adequately documented as an emergency situation; J. Services paid under the free-standing dialysis program described in COMAR 10.09.22; K. Physician assistant billings for those laboratory or X-ray services performed by another facility, which shall bill the Program directly; L. Immunizations required for travel outside the continental United States; M. Acupuncture; N. Hypnosis; O. Travel expenses; P. Prescriptions and injections for central nervous system stimulants and anoretic agents when used for weight control; Q. Investigational or experimental drugs and procedures; R. Services denied by Medicare as not medically justified; and S. Services for which the patient specifically requests to see a physician. #### Regulation .06 Payment Procedures. *COMAR 10.09.55.06* A. The provider shall submit the request for payment in the format designated by the Department. B. The Department reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by any properly completed forms required by the Department. C. The provider shall charge the Program the provider's customary charge to the general public for similar services and charge the provider's acquisition cost for injectable drugs or dispensed medical supplies. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §D of this regulation; and (2) The provider's reimbursement is not limited to the provider's customary charge. D. The Department shall reimburse the physician assistant for covered services at the lesser of: (1) The provider's customary charge unless the service is free to individuals not covered by Medicaid; or (2) The maximum rates according to COMAR 10.09.02.07E. E. Payments on Medicare claims are authorized, if: (1) Services are covered by the Program; (2) The provider accepts Medicare assignments; (3) Medicare makes direct payment to the provider; (4) Medicare has determined that services were medically justified; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. F. The Department shall make supplemental payments on Medicare claims subject to the following provisions: (1) Deductible insurance shall be paid in full; and (2) Coinsurance shall be paid at the lesser of: (a) 100 percent of the coinsurance amount; or (b) The balance remaining after the Medicare payment is subtracted from the Medicaid rate. G. The provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; and (4) Providing a copy of a participant's medical record when requested by another licensed provider on behalf of the participant. H. The Program may not make direct payment to participants. I. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. J. Physician assistants who are employed by or under contract to any physician, clinic, or hospital may not bill for any service for which reimbursement is sought by the physician, clinic, or hospital. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.55.07* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.55.08* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.55.09* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.55.10* State regulations shall be interpreted in conformity with COMAR 10.09.36.10. ### Chapter 56 — Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-130, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 2001 (28:12 Md. R. 1108) **Administrative History:** Regulation .01C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .02A, B amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .02B amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .04 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .04D amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .05A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .06 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .07C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .07C amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .08A amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .08A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .10F, G, H amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .11C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .12 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .13 repealed as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); repealed permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .14 amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .15A, C amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .16A amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .21E amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Regulation .21F amended as an emergency provision effective October 1, 2004 (32:1 Md. R. 24); amended permanently effective April 25, 2005 (32:8 Md. R. 741) **Administrative History:** Regulation .22C amended as an emergency provision effective July 1, 2002 (29:17 Md. R. 1376); emergency status extended at 30:3 Md. R. 176 and 30:10 Md. R. 667; amended permanently effective April 14, 2003 (30:7 Md. R. 487) **Administrative History:** Chapter revised effective August 13, 2007 (34:16 Md. R. 1432) **Administrative History:** Regulation .22D amended effective February 8, 2010 (37:3 Md. R. 176) **Administrative History:** Chapter revised effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .01B amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449); May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .02 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .02A amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .02A, B amended effective April 16, 2012 (39:7 Md. R. 492); May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .03B amended effective May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .04 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449); September 16, 2024 (51:18 Md. R.809) **Administrative History:** Regulation .05 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .05E amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .05Q amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .06 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .06E, M amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .06-1 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .06-1P amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .06-2 adopted effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .07 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .08 amended effective April 16, 2012 (39:7 Md. R. 492); April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .10A amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .11E amended effective April 11, 2016 (43:7 Md. R. 449); May 18, 2020 (47:10 Md. R. 516) **Administrative History:** Regulation .11G, H adopted effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .14 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .14B amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .14C amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .14G amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .14-1 adopted effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .14-1B amended effective September 16, 2024 (51:18 Md. R.809) **Administrative History:** Regulation .14-1C adopted effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .15 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .15D amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .15E adopted effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .16C adopted effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .16C amended effective September 16, 2024 (51:18 Md. R.809) **Administrative History:** Regulation .16D adopted effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .17 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .17E amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .17F adopted effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .19 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .19B, C amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .19D adopted effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .21 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .21E, H amended effective May 18, 2020 (47:10 Md. R. 516); September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .21J adopted effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .22A, E amended effective November 27, 2023 (50:23 Md. R. 1004) **Administrative History:** Regulation .22D amended effective October 31, 2011 (38:22 Md. R. 1346); April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .22D, E amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .22E amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .24 amended effective April 16, 2012 (39:7 Md. R. 492) #### Regulation .01 Definitions. *COMAR 10.09.56.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Active Treatment. (a) “Active treatment” means, according to 42 CFR §483.440(a), a continuous active treatment program which includes aggressive, consistent implementation of a program of specialized and generic training, treatment, health services, and related services that is directed toward the: (i) Acquisition of the behaviors necessary for the individual to function with as much self-determination and independence as possible; or (ii) Prevention or deceleration of regression or loss of current optimal functional status. (b) “Active treatment” does not mean, according to 42 CFR §483.440(a), services to maintain generally independent individuals who are able to function with little supervision or in the absence of a continuous active treatment program. (2) “Applicant” means an individual who is applying as a participant in the Autism Waiver. (3) “Autism” has the meaning stated in §C of this regulation. (4) “Autism Waiver” means the Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder. (5) “Certified special educator” means a professional who holds an appropriate certificate as defined by COMAR 13A.12.01.02. (6) “Department” means the Maryland Department of Health, or its authorized agents acting on behalf of the Department. (7) “Developmentally disabled” means a condition, as specified in 42 CFR §435.1010 for persons with related conditions, resulting in a severe, chronic disability which meets all of the following conditions: (a) Is attributable to: (i) Cerebral palsy or epilepsy; or (ii) A condition such as autism, except for mental illness, which is found to be closely related to intellectual disability because the condition results in impairment of general intellectual functioning or adaptive behavior similar to that of intellectually disabled individuals, and requires treatment or services similar to those required for intellectually disabled individuals; (b) Is manifested before the individual is 22 years old; (c) Is likely to continue indefinitely; and (d) Results in substantial functional limitations in three or more of the following areas of major life activities: (i) Self-care; (ii) Understanding and use of language; (iii) Learning; (iv) Mobility; (v) Self-direction; (vi) Capacity for independent living; or (vii) Other areas of major life activities. (8) “Early intervention services” means services that: (a) Are designed to meet the developmental needs of infants and toddlers with disabilities; (b) Are provided under public supervision and in conformity with an individualized family service plan; and (c) Meet applicable State and federal standards. (9) “Eligible person” means an individual who meets the qualifications, as specified in Regulation .02 of this chapter, for participation in the Autism Waiver. (10) “Family” means adults who: (a) Live with or provide care to the participant; and (b) Are not paid to provide the care. (11) “HIPAA” means the Health Insurance Portability and Accountability Act of 1996 developed to improve portability of health insurance coverage, reduce healthcare fraud and abuse, and protect individual privacy of personal health records. (12) “Home and Community-Based Services Waiver for Children with Autism Spectrum Disorder” means the program implemented under this chapter in accordance with the document, and any amendments to it, submitted by the Department to, and approved by, the Secretary of the U. S. Department of Health and Human Services, which authorizes the waiver, pursuant to §1915(c) of Title XIX of the Social Security Act, of certain specified statutory requirements limiting coverage for home and community-based services under the Medical Assistance Program. (13) “ICF-ID level of care” means an assessment that an individual needs the level of services provided in an intermediate care facility for the intellectually disabled and persons with related conditions (ICF-ID), including active treatment. (14) “Individualized education program (IEP)” means a written statement for a student with a disability that is developed, reviewed, and revised in accordance with 20 U.S.C. §1414 and COMAR 10.09.52. (15) “Individualized family service plan (IFSP)” means a written, individualized plan for early intervention and other services for an infant or toddler, in accordance with COMAR 10.09.40, 10.09.50, and 13A.13.01. (16) “Intermediate care facility for individuals with intellectual disabilities (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that: (a) Is primarily for the diagnosis, treatment, or rehabilitation of individuals with intellectual disabilities or persons with related conditions; and (b) Provides, in a protected residential setting, ongoing evaluation, planning, 24-hour supervision, coordination, and integration of health or rehabilitative services to help each individual function at the individual's greatest ability. (17) “Local lead agency” means the agency designated by the local governing authority in each jurisdiction to administer the interagency system of early intervention services under the direction of the State Department of Education. (18) “Local school system” means the public local education agency in each jurisdiction. (19) “Medicaid” means the Medical Assistance Program. (20) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01B. (21) “Multidisciplinary team” means the IEP team or IFSP participants, consistent with the Individuals with Disabilities Education Act (IDEA), which is convened for a participant. (22) Parent. (a) “Parent” means the adult representative of a minor applicant or participant. (b) “Parent” includes: (i) A natural or adoptive parent; (ii) A legal guardian; (iii) A person acting in the place of a parent, such as a grandparent or stepparent, with whom the participant lives, including those relatives or stepparents who are foster parents; (iv) An individual appointed as the parent surrogate in accordance with Education Article, §8-412, Annotated Code of Maryland, for matters within the scope of the Individuals with Disabilities Education Act (IDEA); and (v) Any other person who is legally responsible for the participant's welfare. (23) “Participant” means an eligible person who is enrolled in the Autism Waiver. (24) “Positive behavior intervention” means a range of intervention strategies that are designed to prevent problem behaviors while teaching socially appropriate alternative behaviors. (25) “Program” means the Medical Assistance Program, as stated in COMAR 10.09.36.01B. (26) “Provider” means an individual, association, partnership, corporation, or unincorporated group that: (a) Is approved as meeting the conditions for waiver participation specified in this chapter; and (b) Has enrolled with the Program to provide one or more of the waiver services covered under this chapter. (27) “Provider agreement” means a contract between the Program and a provider. (28) “Qualified diagnostician” means an individual whose license or certification permits diagnosis of Autism Spectrum Disorder. (29) “Recipient” means an individual who is certified by the Department as eligible to receive Program benefits. (30) “Reportable event policy” means a process developed to protect the health and safety of waiver participants in the community by identifying, documenting, and resolving complaints and incidents. (31) “Retainer payment” means payment made to providers of residential habilitation services while the participant is hospitalized or absent from the residential habilitation program. (32) “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food which are provided in or associated with an individual's place of residence. (33) “Service coordinator” means the individual who provides case management services for Autism Waiver participants in accordance with COMAR 10.09.52. (34) “Special educator” means a professional who holds an appropriate certificate as defined by COMAR 13A.12.01.02. (35) “State Department of Education (MSDE)” means the agency responsible for ensuring that all children with disabilities residing in the State are identified, assessed, and provided with a free, appropriate public education consistent with State and federal laws. (36) “State fiscal year” means the 12-month period of July 1 through June 30 over which the State budgets its spending. (37) “State Plan” means the plan for the Medical Assistance Program as submitted by the Department and approved by the Secretary of the U.S. Department of Health and Human Services according to Title XIX of the Social Security Act, as modified or amended. (38) “Waiver plan of care” means the written, individualized treatment plan developed for a participant, which identifies the waiver services covered under this chapter. C. Autism. (1) “Autism” means autism spectrum disorder, which is diagnosed when an individual has a total of six or more of the following items under §C(1)(a), (b), and (c) of this regulation, with at least two from §C(1)(a) and one each from §C(1)(b) and (c): (a) Qualitative impairment in social interaction, as manifested by at least two of the following: (i) Marked impairment in the use of multiple nonverbal behaviors such as eye-to-eye gaze, facial expression, body postures, and gestures to regulate social interaction; (ii) Failure to develop peer relationships appropriate to developmental level; (iii) A lack of spontaneous seeking to share enjoyment, interests, or achievements with other people (for example, by a lack of showing, bringing, or pointing out objects of interest); (iv) Lack of social or emotional reciprocity; (b) Qualitative impairments in communication as manifested by at least one of the following: (i) Delay in, or total lack of, the development of spoken language, not accompanied by an attempt to compensate through alternative modes of communication such as gesture or mime; (ii) In individuals with adequate speech, marked impairment in the ability to initiate or sustain a conversation with others; (iii) Stereotyped and repetitive use of language or idiosyncratic language; (iv) Lack of varied, spontaneous make-believe play or social imitative play appropriate to developmental level; (c) Restricted repetitive and stereotyped patterns of behavior, interests, and activities, as manifested by at least one of the following: (i) Encompassing preoccupation with one or more stereotyped and restricted patterns of interest that is abnormal either in intensity or focus; (ii) Apparently compulsive adherence to specific, nonfunctional routines or rituals; (iii) Stereotyped and repetitive motor mannerisms (for example, hand or finger flapping or twisting, or complex whole body movements); (iv) Persistent preoccupation with parts or objects. (2) “Autism” includes: (a) Delays or abnormal functioning in at least one of the following areas, with onset before age 3 years: (i) Social interaction; (ii) Language as used in social communication; or (iii) Symbolic or imaginative play; (b) An individual's behavior that is not better accounted for by Rett's Disorder or Childhood Disintegrative Disorder; (c) Pervasive Developmental Disorder Not Otherwise Specified (including Atypical Autism, Rett's Disorder, and Asperger's Disorder). #### Regulation .02 Participant Eligibility. *COMAR 10.09.56.02* A. Medical Eligibility for the Autism Waiver. (1) To be medically eligible for the services covered under the chapter, an applicant shall be certified by the licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee to need ICF-IID level of care using the standardized process for determination of eligibility for level of care in an ICF-IID. (2) Every 12 months, or more frequently if determined necessary by the service coordinator or multidisciplinary team due to a significant change in the participant’s condition or needs, a participant’s medical need for ICF-IID level of care shall be reevaluated by the licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee, as part of the multidisciplinary team process and using the form for determination of eligibility for level of care in an ICF-IID. (3) The form certifying ICF-IID level of care shall be signed by the: (a) Chairman of the multidisciplinary team, who is the official representative of the local school system or local lead agency; and (b) Team's licensed psychologist, licensed social worker, licensed clinical professional counselor, certified school psychologist, or approved service coordinator employed or contracted by the local lead agency, the local education agency, the State, or the State’s designee. B. Technical Eligibility for the Autism Waiver. An applicant or participant shall be determined by the multidisciplinary team to meet the waiver’s technical eligibility-criteria if the individual: (1) Is between 1 year old and the end of the school year in which the individual turns 21 years old; (2) Is determined to be developmentally disabled and is diagnosed with autism spectrum disorder, every 3 years or more often as requested by MSDE, by a qualified diagnostician using an evaluation methodology considered sufficient by the multidisciplinary team; (3) Uses at least one waiver service monthly, not including family consultation, unless otherwise authorized by the State Department of Education; (4) Has an IFSP or IEP; (5) If the child has an IEP, receives 15 hours or more per week of special education and related services and requires a more intensive therapeutic program than other students or is currently participating in an approved Home and Hospital Program pursuant to the procedures of COMAR 13A.03.05 and 13A.05.01; (6) Is identified through the public education or early intervention service system as being potentially qualified for and needing Autism Waiver services; (7) Can be safely maintained in the community with the assistance of Autism Waiver services; (8) Chooses, or the parent or parents of a minor child chooses on the child’s behalf, to receive Autism Waiver services as an alternative to services in an (ICF-IID), and documents that choice on the consent form for Autism Waiver services; and (9) Is not enrolled in: (a) Home Care for Disabled Children under a Model Waiver, in accordance with COMAR 10.09.27; (b) Community Based Services for Developmentally Disabled Individuals Pursuant to a 1915(c) Waiver, in accordance with COMAR 10.09.26; or (c) Any other Medicaid waiver program under §1915(c) of Title XIX of the Social Security Act. C. Medical Assistance Eligibility. (1) Categorically Needy. A recipient is eligible for Autism Waiver services if the recipient is eligible for Medicaid in the community according to the categorically needy regulations in COMAR 10.09.24 or 10.09.11. (2) Optionally Categorically Needy. (a) An individual is eligible for Autism Waiver services as optionally categorically needy in accordance with 42 CFR §435.217 if the individual's countable income does not exceed 300 percent of the applicable payment rate for Supplemental Security Income (SSI), and the individual's countable resources do not exceed the SSI resource standard for one. (b) For the purpose of determining financial eligibility for the optionally categorically needy, the individual is treated as an assistance unit of one. (c) For the purpose of determining countable income for the optionally categorically needy, income is determined based on the income regulations in COMAR 10.09.24 which are applicable to aged, blind, or disabled individuals who are institutionalized, with the exceptions specified in §C(4) of this regulation. (d) For the purpose of determining countable resources for the optionally categorically needy, resources are determined based on the resource regulations set forth in COMAR 10.09.24.08 and .10 which are applicable to aged, blind, or disabled persons who are institutionalized, with the exceptions specified in §C(4) of this regulation. (3) An individual is not eligible to receive Autism Waiver services if a disposal of assets or establishment of a trust results in a penalty under COMAR 10.09.24.08-1 or .08-2, until the penalty period expires. (4) All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to Autism Waiver applicants and participants, with the following exceptions: (a) COMAR 10.09.24.04J(1), (2), and (3); (b) COMAR 10.09.24.04K; (c) COMAR 10.09.24.06B(2)(a)(ii); (d) COMAR 10.09.24.08G(1); (e) COMAR 10.09.24.08H; (f) COMAR 10.09.24.09; (g) COMAR 10.09.24.10; and (h) COMAR 10.09.24.10-1. (5) Post Eligibility Determination of Available Income. The participant's or parents' income may not be applied toward the costs of the participant's: (a) Autism Waiver services; or (b) Room and board in a residential habilitation facility. D. Autism Waiver Eligibility. (1) If an applicant is verified by the multidisciplinary team and the State Department of Education: (a) To meet all of the criteria specified in §§A—C of this regulation, the participant’s service coordinator, the representative of the local school system or local lead agency, the representative of the State Department of Education, and the Program shall certify Autism Waiver eligibility and the Program shall establish the effective date for enrollment; or (b) Not to meet all of the criteria specified in §§A—C of this regulation: (i) The service coordinator, the representative of the local school system or local lead agency, and the representative of the State Department of Education shall certify the Autism Waiver eligibility determination; and (ii) The applicant, or the parent or parents of a minor child, shall be informed in writing by the Department for ineligibility, and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 10.09.24.13, and 42 CFR Part 431, Subpart E. (2) Every 12 months, or more often if there is a significant change in the participant's condition or needs: (a) The multidisciplinary team and the State Department of Education shall verify whether the participant remains eligible for the Autism Waiver by meeting all of the criteria specified in §§A—C of this regulation; (b) The service coordinator, the representative of the local school system or local lead agency, and the representative of the State Department of Education shall certify the redetermination of Autism Waiver eligibility; and (c) If the multidisciplinary team and the State Department of Education verify that the participant no longer meets all of the eligibility criteria specified in §§A—C of this regulation, the: (i) Participant's eligibility shall be terminated, as of the effective date established by the multidisciplinary team and the State Department of Education, and (ii) Participant, or the parent or parents of a minor child, shall be informed in writing of the determination, the reason or reasons for ineligibility, and the right to appeal and request a fair hearing, in accordance with COMAR 10.01.04 and 10.09.24.13, and 42 CFR Part 431, Subpart E. #### Regulation .03 Care Planning Process. *COMAR 10.09.56.03* A. Multidisciplinary Team. (1) A multidisciplinary team shall be convened by the local school system or local lead agency in accordance with COMAR 10.09.52 to: (a) Assess or reassess an applicant's or participant's need and eligibility for Autism Waiver services; (b) Review the applicant's or participant's IEP or IFSP, as necessary; and (c) Develop or review, and revise as necessary, the applicant's or participant's Autism Waiver plan of care. (2) The multidisciplinary team shall include: (a) The applicant's or participant's service coordinator who shall attend at least one statewide Autism Waiver training session per year; (b) The applicant's or participant's parent or parents; (c) A chairman who is the official representative of the local school system or local lead agency; (d) Other appropriate professionals representing the local school system or local lead agency, as necessary and consistent with the Individuals with Disabilities Education Act (IDEA); and (e) Other service providers and individuals, as appropriate. A-1. Risk Assessment. (1) Upon initial review, or if the participant's status changes, the service coordinator shall conduct a risk assessment to ensure the applicant can be safely maintained in a home and community-based setting utilizing Autism Waiver services. (2) A risk assessment shall be conducted by the service coordinator using the Autism Waiver Risk Assessment form. B. A participant’s Autism Waiver plan of care or plan of care addendum: (1) Identifies the specific Autism Waiver services to be provided to the participant, as covered under this chapter; (2) Specifies for each identified Autism Waiver service the: (a) Description of the specific service to be provided; (b) Service start date; (c) Estimated duration; (d) Approved frequency and units of services to be delivered; and (e) Provider; and (3) Identifies medical conditions that require a written, signed emergency protocol. #### Regulation .04 Conditions for Participation — General. *COMAR 10.09.56.04* To provide Autism Waiver services, the provider: A. Shall be approved in accordance with the requirements specified in this chapter; B. Shall have a provider agreement in effect, signed with the Program; C. Shall meet all the conditions for participation specified in COMAR 10.09.36, except as otherwise specified in this chapter; D. Shall assure that professional employees who render or delegate services under this chapter have the appropriate experience and health-related license or professional certification to meet the participant's needs, including equivalency review by an accredited agency for credentials obtained outside of the United States, before rendering services to any Autism Waiver participant; E. Shall assure that direct care workers who render services under this chapter: (1) Meet the minimum age requirement, set forth by service, before rendering services to any Autism Waiver participant; (2) Receive adequate and appropriate training, within 60 days of employment and annually thereafter, pertaining to care for children with autism spectrum disorder including: (a) Training concerning abuse, neglect, and exploitation; (b) Positive behavioral interventions and restraints rendered by a MSDE approved trainer; (c) Reportable event policy; and (d) HIPAA; (3) Work under the ongoing supervision of a qualified professional employee of the provider who has annual training in: (a) Abuse, neglect, exploitation; (b) Positive behavioral interventions and appropriate use of restraints rendered by a MSDE-approved trainer; (c) Reportable event policy; and (d) HIPAA; (4) Are approved by the provider as qualified to meet the participant's needs; (5) Are approved by the participant's parents; and (6) Have volunteer or employment experience working with children with autism spectrum disorder or other developmental disabilities as a service provider or as a family member for a minimum of 100 hours, that may include: (a) Internships; (b) Post high school educational experience with developmental disabilities; (c) Shadowing experienced staff; (d) Employment with a developmental disabilities agency; or (e) Fulfilling the community service requirement through volunteering with a child with autism or another developmental disability; F. Shall be required to have a professional on-call at all times, and employ or contract with certain professionals for consultation as needed when providing: (1) Residential habilitation services; (2) Intensive individual support services; and (3) Therapeutic integration services; G. Shall employ on-call professionals and professional consultants: (1) Who are: (a) Board-certified behavior analysts; (b) Certified school psychologists; (c) Certified special educators; (d) Individuals with a masters or doctorate degree in special education or a related field and 5 years experience in providing training or consultation in autism spectrum disorder or other developmental disabilities; (e) Licensed certified social workers; (f) Licensed professional counselors; (g) Nurse psychotherapists; (h) Physicians; (i) Psychologists; (j) Occupational therapists; (k) Physical therapists; (l) Registered nurses; or (m) Speech therapists; and (2) Who have: (a) Experience providing services to children with autism spectrum disorder or other developmental disabilities; (b) A background in behavior management techniques; and (c) Knowledge of the specific children being served by the provider. H. Shall verify the licenses, credentials, and references of all individuals who render or delegate services on the provider's behalf under this chapter, and have a copy of the licenses, credentials, and at least three written references available for inspection; I. Shall maintain current, written, and signed contracts with all contractors providing waiver services on behalf of the provider that include: (1) The scope of services to be performed; (2) The requirement to comply with all applicable Medicaid regulations; (3) The requirement to complete and maintain written documentation of service delivery, individualized for each participant on each day that the participant receives services; (4) A clause that no monies shall be sought from the waiver participant or the participant's family if the contract is breached by either the provider or contractor; and (5) A current copy of a provider license or certification and insurance as required in this chapter; J. With the exception of environmental accessibility adaptation providers, shall submit to a preemployment criminal background investigation; K. With the exception of respite care and environmental accessibility adaptations providers, shall submit separate, written treatment plans to service coordinators within 30 calendar days of the initiation of services in accordance with State guidelines for each individual service and at least once in each 12-month period thereafter, or more frequently if the treatment plan changes; L. If an agency, shall require supervisory and direct care employees of provider agencies to: (1) Submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services, in accordance with Family Law Article, §5-561, Annotated Code of Maryland; (2) Request the Department of Public Safety and Correctional Services to send the child care criminal history report to the Department’s Division of Community Long Term Care; and (3) Not have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or crime involving moral turpitude or theft, or have other criminal history that indicated behavior that is potentially harmful to participants; M. If an agency, shall: (1) Pay for the criminal background check; (2) Request clearance from the Department for all applicants prior to an offer of employment; and (3) Submit monthly Criminal Justice Information System's update reports to the Maryland State Department of Education; N. If self-employed, shall: (1) Submit an application for a criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services; (2) Request the Department of Public Safety and Correctional Services to send the child care criminal history report to the Department’s Division of Community Long Term Care; (3) Pay for the criminal background check; (4) Not have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or crime involving moral turpitude or theft, or have other criminal history that indicated behavior that is potentially harmful to participants; and (5) Submit monthly Criminal Justice Information System’s update reports to the State Department of Education. O. Shall have the option to request the Department to waive the provisions of §§L(3) and N(4) of this regulation if the applicant demonstrates that: (1) The conviction, probation before judgment, or plea of nolo contendere for a felony or any crime involving moral turpitude or theft was entered more than 10 years before the date of the provider’s or prospective employee’s application; and (2) The criminal history does not indicate behavior that is potentially harmful to participants; P. Shall have adequate liability insurance; Q. Shall provide services in accordance with the requirements of the Autism Waiver plan of care, this chapter, the Autism Waiver, and all relevant federal, State, and local laws and regulations; R. Shall agree to submit claims for payment by the Program for only those services covered under this chapter which have been identified and documented in a participant's Autism Waiver plan of care; S. Shall agree to maintain and have available to the Department or the State Department of Education personnel records and written documentation describing waiver services rendered, including dates and hours of services provided to participants, for a period of 6 years, in a manner approved by the Department or its designee; T. Shall agree not to suspend, increase, or reduce services for a participant without a waiver plan of care or plan of care addendum from the service coordinator for that participant; U. Unless a risk to health and safety exists, shall agree not to terminate services for a participant without providing: (1) 30 days written notice to the participant, parent or guardian, and service coordinator; and (2) Assistance in the discharge planning process; V. Is not eligible to participate in the waiver if the provider or any of its principals were previously program providers, or if its principals were principals in program providers, that have overpayments that remain due and owing to the Department; W. Is not eligible if the provider or its principals within the past 24 months have: (1) Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services; (2) Been suspended or removed from participating as a Medicaid provider; (3) Undergone the imposition of sanctions under COMAR 10.09.36.08; (4) Been subject to disciplinary action including actions by providers or any of its principal's licensing board; (5) Been cited by a State agency for deficiencies which affect a participant's health and safety; or (6) Experienced a termination of a reimbursement agreement with or been barred from work or participation by a public or private agency due to: (a) Failure to meet contractual obligations; or (b) Fraudulent billing practices; X. Shall maintain written quarterly records documenting face-to-face supervision of direct care employees and direct observation of the participant that includes: (1) Date and location of supervision; (2) Review, feedback, and oversight of the implementation of treatment plan goals; (3) Review, feedback, and oversight of the implementation of positive behavior intervention; (4) Review, feedback, and oversight of the scope of activities during service; (5) Review, feedback, and oversight of data collection; (6) Date and name of supervisor, name of employee, and name of the participant; and (7) Signature of supervisor; Y. Shall agree to keep all records available for inspection or audit by the Department or the Department's designee at any reasonable time during business hours; Z. Shall implement and follow the Reportable Event policy in accordance with the Department's established policy by: (1) Reporting incidents and complaints to the participant's service coordinator within 24 hours; (2) Submitting a written report within 7 calendar days on a form designated by the Department; and (3) Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subject to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.06.04; AA. May not: (1) Render direct services to the provider's own child; or (2) Render supervision to the direct care worker of the provider's own child; BB. With the exception of environmental accessibility adaptations providers and residential habilitation providers, shall submit to the service coordinator monthly service tracking forms for each participant served within 20 calendar days of the end of each month; CC. With the exception of environmental accessibility adaptations providers, shall attend at least one Autism Waiver training conducted by the State each year and shall participate in: (1) One training annually regarding the prevention, identification, and reporting of abuse, neglect, and exploitation; (2) One training annually regarding positive behavioral intervention and restraints; and (3) All statewide Autism Waiver trainings during any year in which the provider is under recommendation for disenrollment from the waiver or has had Medicaid payments suspended; DD. Shall satisfactorily complete all aspects of the Autism Waiver provider applications process; EE. Shall notify the Program within 15 days of occurrence of any change to contact information; FF. Shall maintain communications with the program by maintaining a working telephone and answering machine, facsimile machine, and e-mail account; GG. Shall have status as a Maryland Medicaid Autism Waiver provider, including the Medicaid provider number, terminated if no services have been provided for 24 consecutive months; HH. Shall, when transportation is provided: (1) Implement the provider’s transportation policy; (2) Identify the driver in daily contact notes or a transportation log; (3) Document the start and stop times transportation is provided for each day that a participant is transported; (4) Maintain a copy of the current automobile liability coverage and documentation of payment for the vehicle transporting a participant; and (5) Maintain a current copy of the valid State driver’s license and driving record for staff transporting a waiver participant; and II. Shall comply with all administrative policies, procedures, transmittals, and guidelines issued by the Department or its designee. #### Regulation .05 Specific Conditions for Participation — Residential Habilitation Services. *COMAR 10.09.56.05* To provide the services covered under Regulation .11 of this chapter, the provider agency shall: A. Provide services in a facility that meets the following requirements: (1) Complies with regulations governing residential programs licensed under the: (a) Developmental Disabilities Administration including COMAR 10.22.02 and 10.22.08; or (b) Governor's Office for Children including COMAR 14.31.06; (2) Has eight or fewer beds, unless approved by the State Department of Education to have up to 16 beds due to special needs of children; (3) Has no more than two individuals in a bedroom; (4) Provides opportunities for participants to have personal items in the participant's bedroom that reflect the participant's personal tastes; (5) Provides for input and participation of the participant into eating times, menus, and meal preparation, as appropriate for specific health conditions and in accordance with treatment standards; (6) Provides opportunities for participants to participate in community activities; and (7) Is located and integrated into a residential community. B. Have at least 3 years of experience in providing habilitation services to children who have autism spectrum disorder or other developmental disabilities; C. Employ a full-time program director, to assure adequate coordination and supervision of the covered services, who has either: (1) A valid Maryland certificate as a special education supervisor, principal, or special educator, and at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or (2) At least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment; D. Provide round-the-clock staffing which: (1) Includes at all times at least one direct care staff person on site for every three children, with more staffing as necessary based on participants' needs; and (2) Unless the provider designates that it does not provide residential habilitation on weekends, is for 365 days a year, E. Have on call 24 hours a day a designated supervisor for the direct care workers, who: (1) Has at least a bachelor's degree in a human services field plus 3 years of experience in the area of autism spectrum disorder or other developmental disabilities, or an associate degree in human services plus 5 years of experience with persons with autism or other developmental disabilities; or (2) Meets the professional guidelines for a qualified intellectual disabilities professional or qualified developmental disabilities professional; F. Demonstrate the necessary staff capacity to provide intensive residential habilitation services when needed by participants; G. Employ or contract with certain professionals who meet provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter for consultation; H. Have at least one professional on call 24 hours a day, 7 days a week for crisis intervention who meets provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter; I. Demonstrate the capability and capacity of providing Autism Waiver residential habilitation services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: (1) Abuse, neglect, and exploitation; (2) Positive behavior interventions and restraints; (3) Implementation of treatment plans; (4) Transportation of participants; (5) Maintenance of required documentation; (6) Training and supervision of staff; (7) Quality assurance; (8) Emergency back-up plans; and (9) HIPAA; J. Assure the provision of services in the least restrictive environment in the community that is appropriate to participants' needs; K. Provide documented evidence of integration of the residential habilitation program with other community-based services received by Autism Waiver participants; L. Document arrangements for the provision of medical services needed by participants, including helping them to get to medical appointments and to obtain services in an emergency; M. For initial approval and as a condition of occupancy of any facility used by the program, submit written documentation from responsible approval or licensing authorities verifying that the facility is in compliance with applicable health, fire safety, and zoning regulations; N. For continued approval, maintain written documentation of compliance with applicable health, fire safety, and zoning regulations as a condition of occupancy of any facility used by the program; O. Assure that the participant's needs are met for shelter, food, clothing, and furnishings; P. Maintain daily contact logs completed on the same day the service is provided and reflective of the individual plan’s goals and community-based activities from Regulation .11F of this chapter; and Q. Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the residential habilitation individual plan. #### Regulation .06 Specific Conditions for Participation — Intensive Individual Support Services. *COMAR 10.09.56.06* To provide the service covered under Regulation .15 of this chapter, the provider shall: A. Have at least 3 years of experience in providing habilitation services to children with autism; B. Employ a full-time program director, to assure adequate coordination and supervision of the covered services, who shall either: (1) Hold a valid Maryland certificate as a special education supervisor, principal, or special educator, and have at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or (2) Have at least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment; C. Employ direct care workers who meet provider qualifications in accordance with Regulation .04E of this chapter; D. Employ or contract with certain professionals for consultation as needed who meet provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter; E. Assure supervision of direct care workers by a: (1) Licensed psychologist; (2) Certified school psychologist; (3) Certified special educator; (4) Licensed certified social worker; (5) Licensed professional counselor; (6) Board Certified Behavioral Analyst; or (7) Individual with a masters or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities; F. Have at least one professional on call at all times for crisis intervention who meets provider qualifications in accordance with Regulation .04G(1) and (2) of this chapter; G. Demonstrate the capability and capacity of providing intensive individual support services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: (1) Abuse, neglect, and exploitation; (2) Positive behavior interventions and restraints; (3) Implementation of treatment plans: (4) Emergency backup plans; (5) Transportation of participants; (6) Maintenance of required documentation; (7) Training and supervision of staff; (8) Quality assurance; and (9) HIPAA; H. Assure the provision of services in the least restrictive environment in the community that is appropriate to a participant's needs; I. Provide documented evidence of integration of the covered services with other community-based services received by Autism Waiver participants; J. Document arrangements to obtain medical services for participants in an emergency; K. Provide the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service, and at least annually thereafter, or more frequently if the treatment plan changes; L. Document goals related to transportation and the participant’s needs on the treatment plan when transportation will be provided; M. Maintain daily contact logs completed on the same day the service is provided and reflective of treatment plan goals and activities; and N. Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the intensive individual support services treatment plan. #### Regulation .06-1 Specific Conditions for Participation — Therapeutic Integration Services. *COMAR 10.09.56.06-1* To provide one or more of the services covered under Regulation .14 of this chapter, the provider shall: A. Have at least 3 years of experience in providing habilitation services to children with autism spectrum disorder or other developmental disabilities; B. Employ a full-time program director to assure adequate coordination and supervision of the covered services, who shall: (1) Hold a valid Maryland certificate as a special education supervisor, principal, or special educator, and have at least 3 years of successful teaching experience, as verified by former employers, in regular or special education, or both, as appropriate for the director's assignment; or (2) Have at least 3 years of relevant experience with counseling or supervision, as appropriate for the director's assignment; C. Employ direct care workers who meet provider qualifications in accordance with Regulation .04E of this chapter; D. Have on site at least one direct care worker for every three participants on the waiver, with more staffing as necessary based on participants’ needs; E. Designate an on-site supervisor for the direct care workers who is: (1) A licensed psychologist; (2) A certified school psychologist; (3) A certified special educator; (4) A licensed certified social worker; (5) A licensed professional counselor; (6) A board-certified behavioral analyst; (7) A licensed or certified as a music, art, drama, dance, or recreation therapist; or (8) An individual with a master's or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities; F. Employ or contract with certain professionals for consultation in accordance with Regulation .04G(1) and (2) of this chapter; G. Have at least one professional on call at all times for crisis intervention in accordance with Regulation .04G(1) and (2) of this chapter; H. Demonstrate the capability and capacity of providing therapeutic integration services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: (1) Abuse, neglect, and exploitation; (2) Positive behavior interventions and restraints; (3) Implementation of treatment plans; (4) Emergency backup plans; (5) Transportation of participants; (6) Maintenance of required documentation; (7) Training and supervision of staff; (8) Quality assurance; and (9) HIPAA; I. Provide documented evidence of services in the least restrictive environment in the community that is appropriate to a participant's needs; J. Provide documented evidence of integration of the covered services with other community-based services received by participants; K. Document arrangements to obtain medical services for participants in an emergency; L. For initial approval and as a condition of occupancy of any facility used by the program: (1) Submit written documentation from responsible agency or licensing authorities verifying that the facility is in compliance with applicable health, fire safety, and zoning regulations; and (2) Allow an on-site review by the MSDE; M. For continued approval, maintain written documentation of compliance with applicable health, fire safety, and zoning regulations as a condition of occupancy of any facility used by the program; N. Provide the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service and at least annually or more frequently if the treatment plan changes; O. Maintain daily contact logs completed on the same day the service is provided and reflective of individual plan goals and activities; and P. Maintain and make available for review by the State, documentation of the 6-month review and update of each participant’s status relative to each goal in the therapeutic integration treatment plan. #### Regulation .06-2 Specific Conditions for Participation — Intensive Therapeutic Integration Services. *COMAR 10.09.56.06-2* To provide one or more of the services covered under Regulation .14-1 of this chapter, the provider shall: A. Meet all the conditions of Regulation .06-1 of this chapter; and B. Have an on-site direct care worker for every participant receiving one-to-one intervention for intensive therapeutic integration. #### Regulation .07 Specific Conditions for Participation — Respite Care. *COMAR 10.09.56.07* A. The respite care provider shall have adequate liability insurance and be appropriately bonded. B. A professional who provides respite care services or supervises a direct care worker rendering the services shall be: (1) Certified in accordance with COMAR 13A.12.01 as a psychologist or special educator; or (2) Licensed as a psychologist, social worker, registered nurse, professional counselor, or occupational therapist; or (3) A qualified developmental disabilities professional in accordance with COMAR 10.09.26.01B(28); (4) Certified nationally by the Behavior Analyst Certification Board as a Board Certified Behavior Analyst; or (5) An individual with a master's degree or doctorate degree in special education or a related field and at least 5 years experience in providing training or consultation in the area of autism spectrum disorder or other developmental disabilities. C. An agency that provides respite care services shall employ direct care workers who meet qualifications in accordance with Regulation .04E of this chapter. D. A respite care provider shall demonstrate the capability and capacity of providing respite care services by submitting documentation of experience and a written implementation plan which includes at a minimum policies and procedures regarding: (1) Abuse, neglect, and exploitation; (2) Positive behavior interventions and restraints; (3) Emergency backup plans; (4) Transportation of participants; (5) Maintenance of required documentation; (6) Training and supervision of staff; (7) Quality assurance; and (8) HIPAA. E. Documentation of Service. (1) Maintain daily contact logs completed on the same day the service is provided and reflective of interventions; and (2) Make documentation of services available for review by the State, when requested. #### Regulation .08 Specific Conditions for Participation — Family Consultation. *COMAR 10.09.56.08* A. To provide the services covered under Regulation .17 of this chapter, a consultant shall be: (1) Certified in accordance with COMAR 13A.12.01 as a psychologist, special educator, or speech therapist; (2) Licensed as a psychologist, certified social worker, nurse psychotherapist, speech therapist, professional counselor, marriage and family therapist, or occupational therapist; (3) Nationally certified as a Board Certified Behavior Analyst; or (4) An individual with a master's or doctorate degree from an accredited university in special education or a related field and have at least 5 years experience providing training or consulting in the area of autism spectrum disorder; and B. The provider shall have training and at least 2 years of experience, which: (1) Is relevant to the family’s needs; (2) Is related to behavior intervention or how to keep the child safe in the home environment; and (3) Was involved with providing services to children with autism spectrum disorder as a service provider or as a family member. C. The provider shall develop a plan with goals and interventions and submit the plan to the participant’s service coordinator within 30 calendar days of initiation of service delivery, and at least annually thereafter, or more frequently if the instructional plan changes. D. The provider shall demonstrate the capability and capacity of providing family consultation services by submitting documentation of experience and a written implementation plan. E. The provider shall maintain family contact logs completed on the same day the service is provided that are reflective of the family plan, goals and activities. F. The provider shall maintain and make available for review by the State, documentation of the 6-month review and update the status relative to each goal in the family plan. #### Regulation .09 Specific Conditions for Participation — Environmental Accessibility Adaptations. *COMAR 10.09.56.09* To provide the services covered under Regulation .18 of this chapter, the provider shall: A. Be the store, vendor, contractor, or builder from which the adaptation is purchased; B. Be able to install the adaptation, if necessary; C. Be able to service or maintain the adaptation, as necessary; and D. If construction is involved: (1) Have the appropriate State license as a contractor or builder; and (2) Be appropriately and adequately bonded. #### Regulation .10 Specific Conditions for Participation — Adult Life Planning Services. *COMAR 10.09.56.10* A. To provide the services covered under Regulation .19 of this chapter, the provider shall: (1) Be an individual with a bachelor’s degree; and (2) Have 3 years of full-time experience serving adults with autism disabilities. B. Adult life planning service providers shall work with the participants and the participants families to develop a treatment plan incorporating the principles of self-determination, person-centered planning, decision making, and planning for adulthood. C. The provider shall submit the treatment plan to the participant's service coordinator within 30 calendar days of initiation of service delivery, and at least annually thereafter, or more frequently if the plan changes. D. At the completion of each year of adult life planning services, the provider shall provide a report of documented evidence of progress towards self-determination, community integration, and coordination with adult services. E. The provider shall maintain Adult Life Planning contact logs completed on the same day the service is provided and reflective of the Adult Life Planning treatment plan goals and activities. #### Regulation .11 Covered Services — Residential Habilitation Services. *COMAR 10.09.56.11* A. The Program under this regulation does not cover the following: (1) Any Medicaid State Plan services which are provided by medical professionals employed by or under contract with the residential habilitation provider; (2) Room and board; (3) Direct or indirect payments to the participant's immediate family; (4) Routine care and supervision which a family is expected to provide; (5) Activities or supervision reimbursed by a source other than Medicaid; and (6) The facility's maintenance, upkeep, and improvement. B. The residential habilitation program shall: (1) Provide community-based, intensive residential placements for participants who cannot live at home at the present time because they require highly supervised and supportive environments; (2) Provide a home-like, safe, 24-hour, therapeutic living environment of treatment, intervention, training, supportive care, and oversight; (3) Be designed to assist Autism Waiver participants in acquiring, retaining, and improving the self-help, socialization, and adaptive skills necessary to reside successfully in home and community-based settings; (4) Work closely with the participant's service coordinator to provide transition services for each participant in placement to allow, as appropriate, for the: (a) Participant's eventual return to the family (natural, adoptive, or surrogate); or (b) Participant to acquire the skills and resources for group or independent living; and (5) Coordinate with the participant's educational, health, and medical service providers. C. A participant's placement in residential habilitation services shall be: (1) Preauthorized by the multidisciplinary team; and (2) Reviewed by the multidisciplinary team at least annually. D. Residential habilitation services shall be received in facilities located in the State which are: (1) Licensed group homes; (2) Licensed alternative living units; or (3) Community-based residential facilities approved by the State Department of Education for special education services. E. Intensity Levels. (1) Residential habilitation services are provided and reimbursed at a regular or intensive level for a participant. (2) To be approved by the multidisciplinary team for the intensive level of residential habilitation services, the participant must need: (a) Awake overnight staffing; and (b) At minimum, 4 hours of one-on-one staffing. F. Services. (1) A residential habilitation program shall provide all of the services listed in §F(2)—(12) of this regulation, as necessary for the participant. (2) Habilitation. The residential rehabilitation program shall provide training to assist a participant to acquire, retain, or improve skills in a wide variety of areas that directly affect the ability to reside as independently as possible. (3) Behavior Shaping and Management. The residential rehabilitation program shall train, supervise, and assist the participant, which may include psychiatric or psychological interventions, in appropriate communication and expression of emotions and desires, compliance, assertiveness, acquisition of socially appropriate behaviors, and reduction of inappropriate behaviors. (4) Daily Living Skills. The residential rehabilitation program shall train or assist the participant in dressing, personal hygiene, self-administration of medications, proper use of appliances and adaptive or assistive devices, home safety, first aid, and emergency procedures. (5) Self-Direction. The residential rehabilitation program shall train the participant in identifying and responding to dangerous or threatening situations, making decisions and choices affecting the participant's life, and initiating changes in living arrangements or life activities. (6) Functional Living Skills Training. The residential rehabilitation program shall train the participant in self-reliance, money management, and money handling and purchases. (7) Socialization. The residential rehabilitation program shall train, supervise, or assist the participant to facilitate the participant's involvement in general community activities and establishment of relationships with peers, which may: (a) Not include participation in activities which are solely diversional or recreational in nature; and (b) Include: (i) Assisting the participant with learning and practicing skills of cooperation and participation; (ii) Assisting the participant to identify and participate in activities of interest; and (iii) Providing specific training activities necessary to assist the participant to participate in activities of interest on an ongoing basis. (8) Mobility. The residential rehabilitation program shall train, supervise, and assist the participant to: (a) Enhance movement within the participant's living, working, or education environment; (b) Master the use of adaptive aids and equipment; and (c) Access and use public transportation, independent travel, or other movement within the community. (9) Transportation. The residential rehabilitation program shall provide transportation for the participant to recreation, leisure activities, or skills training. (10) Crisis Intervention and Planning. The residential rehabilitation program shall include: (a) Planning for crises in the participant's residential habilitation placement; and (b) Making the necessary behavioral or environmental interventions to stabilize and preserve the participant's residential habilitation placement, or resolve an intensive behavioral episode. (11) Medication Management, Monitoring, and Training. The residential rehabilitation program shall provide, as needed and appropriate, medication management, monitoring, and training in accordance with the Maryland Nurse Practice Act and COMAR 10.27.11. (12) Transition Services. The residential rehabilitation program shall provide training and experiential learning activities for a participant in a residential habilitation placement, which: (a) Assist with developing discharge planning goals for the participant; (b) Assist the participant in making the transition to home, the next planned placement, or independent living; (c) Are responsive to the participant's individualized developmental and behavioral needs; and (d) Promote self-reliance and age-appropriate behavior. G. A supervisor who has been trained in accordance with Regulation .04E(3) of this chapter shall: (1) Train and provide ongoing supervision to the direct care worker rendering residential habilitation services; (2) Supervise the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervene to reduce the likelihood of reoccurrence; (3) Plan and regularly review the participant’s therapeutic activities and behavior plan; (4) Meet regularly with the participant and family and observe the participant in the residential habilitation setting; and (5) Develop and identify on the individualized treatment plan, the goals, interventions, and tasks that the residential habilitation direct care worker is implementing. H. A unit of service for residential habilitation shall be on a per diem basis. #### Regulation .12 Repealed. *COMAR 10.09.56.12* #### Regulation .13 Repealed. *COMAR 10.09.56.13* #### Regulation .14 Covered Services — Therapeutic Integration Services. *COMAR 10.09.56.14* A. Therapeutic integration services under this regulation: (1) Are provided at a nonresidential setting separate from the home or facility where the participant lives; (2) Focus on expressive therapies and therapeutic recreational activities; (3) Include as important components the development of socialization skills, enhancement of self-esteem, and behavior management; (4) Are especially needed for participants who have problems with socialization, isolation, hyperactivity, impulse control, and behavioral or other related disorders; (5) Are not solely educational or recreational in nature, but have a therapeutic habilitative orientation, as evidenced in written progress notes; (6) Shall be culturally competent and congruent with the participant's cultural norms; (7) May include individual or group counseling; (8) Shall assure coordination with the participant's other service providers, service coordinator, and multidisciplinary team; (9) Shall be guided by the participant's individualized treatment plan; (10) Shall be based on an individualized written plan that identifies goals of the specific therapeutic activities provided; (11) Shall provide: (a) General therapeutic and therapeutic recreational services; (b) Behavioral management; (c) Planning for crises with the participant during a session; (d) Socialization groups; and (e) One or more of art, music, dance, or activity therapies, as appropriate for participants; (12) Shall have a supervisor who has been trained in accordance with Regulation .04E(3) of this chapter that: (a) Trains and provides ongoing supervision to the direct care worker rendering therapeutic integration services; (b) Supervises the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervenes to reduce the likelihood of reoccurrence; (c) Plans and regularly reviews the participant’s therapeutic activities and behavior plan; (d) Meets regularly with the participant and family and observes the participant in the community setting; and (e) Develops and identifies, on the individualized treatment plan, the goals, interventions, and tasks that the therapeutic integration direct care worker is implementing; (13) Shall, when transportation is provided: (a) Have individualized goals for transportation for the participant on the participant’s treatment plan; and (b) Document the start and stop times transportation is provided for each day that a participant is transported; B. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the community setting. C. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the community setting. #### Regulation .14-1 Covered Services — Intensive Therapeutic Integration Services. *COMAR 10.09.56.14-1* A. Intensive therapeutic integration services under this regulation: (1) Are provided at a nonresidential setting separate from the home or facility where the participant lives; (2) Shall have an on-site direct care worker for every participant receiving one-to-one interventions for intensive therapeutic integration; (3) Shall include expressive therapies and therapeutic recreational activities; (4) Shall include the development of socialization skills, enhancement of self-esteem, and behavior management; (5) Are for participants who require one-to-one interventions and also have problems with socialization, isolation, hyperactivity, impulse control, and behavioral or other related disorders; (6) Are not solely educational or recreational in nature, but have a therapeutic habilitative orientation, as evidenced in written progress notes; (7) Shall be culturally competent and congruent with the participant’s cultural norms; (8) Shall assure coordination with the participant’s other service providers, service coordinator, and multidisciplinary team; (9) Shall be based on the participant’s individualized written treatment plan that identifies goals of the specific therapeutic activities provided; (10) Shall provide: (a) General therapeutic and therapeutic recreational services; (b) Behavioral management; (c) Planning for crises with the participant during a session; (d) Socialization groups; and (e) One or more of art, music, dance, or activity therapies, as appropriate for participants; (11) Shall have a supervisor who has been trained in accordance with Regulation .04E(3) of this chapter that: (a) Trains and provides ongoing supervision to the direct care worker rendering therapeutic integration services; (b) Supervises the direct care worker when crisis intervention services are rendered to evaluate the nature of the crisis and intervenes to reduce the likelihood of reoccurrence; (c) Plans and regularly reviews the participant’s therapeutic activities and behavior plan; (d) Meets regularly with the participant and family and observes the participant in the community setting; (e) Develops intervention on an individualized basis and identifies the interventions on an individualized treatment plan; and (f) Identifies, in the treatment plan, the goals and tasks that the intensive therapeutic integration direct care worker is implementing; and (12) Shall, when transportation is provided: (a) Have individualized goals for transportation for the participant on the participant’s treatment plan; and (b) Document the start and stop times transportation is provided for each day that a participant is transported. B. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the community setting. C. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the community setting. #### Regulation .15 Covered Services — Intensive Individual Support Services. *COMAR 10.09.56.15* A. Intensive individual support services: (1) Are intensive, one-on-one interventions with the participant provided by a direct care worker; (2) May be received by the participant on a long-term basis; (3) Are authorized in the participant's Autism Waiver plan of care if the participant's behavior without this intervention would require a more restrictive residential or treatment setting; (4) May be provided in the participant's home or another setting except a residential or youth camp facility; (5) May be provided by more than one direct care worker necessitating ongoing coordination between the direct care workers; (6) Are goal-oriented and task-oriented, with interventions developed on an individualized basis based on the participant's individualized treatment plan; (7) Use the home and community environment as a learning experience and opportunity to illustrate and model alternative ways for the participant to behave; (8) Assist the participant in achieving successful home and community living through structured support, reinforcement, modeling, and behavior management, as evidenced in written progress notes; (9) Shall, when transportation is provided: (a) Have individualized goals for transportation for the participant on the participant's plan; and (b) Document the start and stop times transportation is provided for each day that a participant is transported; (10) Are intended to: (a) Prevent or defuse crises; (b) Promote developmental and social skills growth; (c) Provide the participant with behavior management skills; (d) Give the participant a sense of security and safety; (e) Assist the participant with maintaining self-sufficiency and impulse control; (f) Improve the participant's positive self-expression and interpersonal communication; (g) Improve the participant's ability to function and cooperate in the home and community; (h) Reverse negative behaviors and attitudes; and (i) Foster stabilization; and (11) Include: (a) One-on-one support, assistance, oversight, and intervention; (b) Time-structuring activities; (c) Immediate behavioral reinforcements; (d) Time-out strategies; and (e) Crisis intervention techniques. B. Direct care workers and supervisors rendering intensive individual support services shall collaborate with the participant's family, providers of other waiver services, and other professionals working with the participant in the home or other community settings, including the schools. C. A professional who meets the provider qualifications of Regulation .04G(1)(a)—(f) of this chapter shall: (1) Train and provide ongoing supervision to the direct care worker rendering intensive individual support services; (2) Supervise the direct care worker when crisis intervention services are rendered, to evaluate the nature of the crisis and intervene as necessary to reduce the likelihood of reoccurrence; (3) Plan and regularly review the participant's therapeutic activities and behavior plans; (4) Meet regularly with the participant and family and observe the participant in the home setting; (5) Develop intervention on an individualized basis and identify the interventions on an individualized treatment plan; and (6) Identify in the treatment plan goals and tasks that the intensive individual support services direct care worker is implementing. D. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. E. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. #### Regulation .16 Covered Services — Respite Care. *COMAR 10.09.56.16* A. Respite care: (1) Shall consist of one-on-one interventions with the participant; (2) Shall be rendered by a qualified: (a) Professional who meets the qualifications in Regulation .07B of this chapter; or (b) Direct care worker who is supervised by a qualified professional; (3) Shall include assistance with activities of daily living provided to participants who are unable to care for themselves; (4) Shall be furnished on a short-term basis because of the absence of or need for relief of the participant's family that normally provides the care; (5) Shall be provided in the participant's home or place of residence, or community setting, not including a residential habilitation facility; (6) May be provided in a youth camp certified by the Maryland Department of Health under COMAR 10.16.06; and (7) May be provided in a site licensed to accommodate individuals for respite care by the Developmental Disabilities Administration. B. Respite care may not: (1) Be available for participants receiving residential habilitation services; (2) Include the direct care worker's or the participant's room and board; or (3) Be rendered by a participant's parent. C. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. D. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. #### Regulation .17 Covered Services — Family Consultation. *COMAR 10.09.56.17* A. Family consultation shall be provided as specified in the family consultation plan, and: (1) Shall be based on family-oriented goals to benefit the participant; (2) Shall be provided to one family at a time; (3) May not include advocacy regarding a participant's IEP; and (4) May not include training and supervision of direct care workers. B. A participant's family: (1) Shall be trained by a qualified licensed or certified professional to provide intensive one-on-one interventions with the participant; (2) May be instructed in the treatment regimens, behavior intervention and modeling, skills training, and use of equipment specified in the participant's Autism Waiver plan of care; (3) Shall be provided with training updates as necessary to maintain the participant safely at home; and (4) Shall be present to receive family consultation services. C. Services. (1) A participant’s family shall receive in-person, individualized consultation when providing the habilitation services listed in §C(2)—(8) of this regulation, as necessary for the participant. (2) Habilitation. The participant’s family shall receive consultation to assist the participant to acquire, retain, or improve skills in a wide variety of areas that directly affect the participant’s development and ability to reside as independently as possible, including communication skills. (3) Self-Direction. The participant’s family shall receive consultation to assist the participant in: (a) Identifying and responding to dangerous or threatening situations; (b) Making decisions and choices affecting the participant's life; and (c) Initiating changes in living arrangements or life activities, as appropriate. (4) Behavior Shaping and Management. The participant’s family shall receive consultation to assist the participant with appropriate expression of emotions and desires, compliance, assertiveness, acquisition of socially appropriate behaviors, and the reduction of inappropriate behaviors. (5) Daily Living Skills. The participant’s family shall receive consultation to assist the participant, as appropriate, in: (a) Dressing; (b) Eating; (c) Personal hygiene; (d) Self-administration of medications; (e) Proper use of appliances and adaptive or assistive devices; (f) Home safety; (g) First aid; and (h) Emergency procedures. (6) Socialization. The participant’s family shall receive consultation which facilitates the participant’s involvement in family and community activities and establishing relationships with siblings and peers, which may include: (a) Assisting the participant to identify activities of interest; (b) Arranging for participation in those activities; and (c) Identifying specific interventions necessary to assist the participant’s involvement in those activities on an ongoing basis. (7) Mobility. The participant’s family shall receive consultation to assist the participant with: (a) Enhancing movement within the participant's living arrangement; (b) Mastering the use of adaptive aids and equipment; and (c) Accessing and using public transportation, independent travel, or other movement within the community. (8) Money Management. The participant’s family shall receive consultation to assist the participant with: (a) Handling personal finances; (b) Making purchases; and (c) Meeting personal financial obligations. D. Family consultation does not include activities that are not covered under §C of this regulation. E. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. F. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. #### Regulation .18 Covered Services — Environmental Accessibility Adaptations. *COMAR 10.09.56.18* A. Environmental accessibility adaptations are those physical adaptations to the participant's home, which are reasonable and medically necessary to: (1) Prevent the participant's institutionalization; (2) Assure: (a) The participant's health, welfare, and safety; and (b) A safe, therapeutic environment; (3) Prevent the participant's self-injurious behavior; and (4) Enable the participant to function with greater independence in the home. B. Environmental accessibility adaptations include: (1) Alarms or locks on doors, windows, or fences; (2) Protective padding on walls or floors; (3) Plexiglass on windows; (4) Outside gates and fences; (5) Brackets for appliances; (6) Raised electrical switches and sockets; (7) Safety screen doors; and (8) Individual tracking devices. C. The environmental accessibility adaptations shall be preauthorized in the participant's plan of care and by the State Department of Education. D. All construction shall: (1) Be provided in accordance with applicable State or local building codes; and (2) Pass the required inspections. E. Window locks may only be used if there is no other way to prevent a participant's rapid movement into a potentially dangerous situation. F. With the added safety precautions, it shall be assured that the house has enough exits, so there are not fire or safety concerns. G. Several rooms may be secured, but not the whole house. H. As appropriate, the adaptations shall be approved by the fire department or fire marshal as meeting the fire safety requirements. I. This service is not covered for facilities where residential habilitation services are delivered. J. Excluded are those adaptations or improvements to the home, such as carpeting, roof repair, and central air conditioning, which: (1) Are of general utility; (2) Are not of direct medical or remedial benefit to the participant; or (3) Add to the home's total square footage. #### Regulation .19 Covered Services — Adult Life Planning Services. *COMAR 10.09.56.19* A. Adult life planning services shall be provided as specified in the adult life planning treatment plan. B. Adult life planning services shall: (1) Result in the participant's transition from Autism Waiver services to comparable, necessary adult life services; (2) Be based on the participant's need for services and support after disenrollment from the Autism Waiver; and (3) Be provided only to participants age 14 years old or older. C. For dates of service before July 1, 2023, a unit of service is a 30-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. D. For dates of service on or after July 1, 2023, a unit of service is a 15-minute increment of service rendered to a participant by a qualified provider in the participant’s home or a community setting. #### Regulation .20 Conditions for Reimbursement. *COMAR 10.09.56.20* The Department shall reimburse for services under this chapter when the services are: A. Provided to a participant who meets the qualifications for eligibility specified in Regulation .02 of this chapter; B. Preauthorized in the participant's plan of care by the State Department of Education and the multidisciplinary team, as being reasonable and medically necessary to prevent institutionalization; C. Provided by an approved provider which meets the conditions for participation of this chapter; and D. Rendered pursuant to: (1) The relevant definition of covered services in this chapter; (2) All other requirements specified in this chapter; and (3) The Autism Waiver proposal and any amendments to it approved by the Secretary of the U.S. Department of Health and Human Services. #### Regulation .21 Limitations. *COMAR 10.09.56.21* A. Reimbursement may be made by the Program only when all of the requirements of this chapter are met. B. Residential habilitation services may not be reimbursed for the same date of service as intensive individual support services, therapeutic integration services, intensive therapeutic integration services, or respite care. C. Therapeutic integration services, intensive therapeutic integration services, and intensive individual support services under this chapter and school health-related services under COMAR 10.09.50 may not be reimbursed for the same period of the same day. D. Therapeutic integration and intensive therapeutic integration services may not be rendered during the same week to a participant. E. Therapeutic integration and intensive therapeutic integration services may include transportation time when at least 2 units of service have been provided on-site, and the maximum units of service billed may not exceed 12 units. (1) For dates of service before July 1, 2023, 24 units; or (2) For dates of service on or after July 1, 2023, 12 units. F. Environmental accessibility adaptations may be reimbursed only if preauthorized by the State Department of Education. G. If an environmental accessibility adaptation is anticipated to cost over $500, at least two bids or prices shall be obtained, based on which the State Department of Education may approve the purchase. H. The Program may reimburse for a participant not more than: (1) For dates of service before July 1, 2023: (a) 1 unit per date of service for residential habilitation services at either the regular or intensive level; (b) 40 units of therapeutic integration services per week; (c) 30 units of intensive therapeutic integration services per week; (d) 12 units or fewer than 2 units of therapeutic integration or intensive therapeutic integration services for a date of service; (e) 50 units of intensive individual support services per week; (f) 48 units of respite care for a date of service; (g) 672 units of respite care per State fiscal year; (h) 12 units of family consultation for a date of service; (i) 80 units of family consultation per State fiscal year; (j) A total of $2,000 for environmental accessibility adaptations over a 36-month period; (k) 16 units of intensive individual support services per day; (l) 30 units of adult life planning services per State fiscal year, for participants 16 years old or older; (m) A lifetime maximum of 90 units of adult life planning services per participant, for participants 16 years old or older; and (n) 15 units of retainer payment per calendar year at either the regular or intensive level when the participant is absent from the residential habilitation program for the purposes of family visitation, hospitalization, or other overnight stays; or (2) For dates of service on or after July 1, 2023: (a) 1 unit per date of service for residential habilitation services at either the regular or the intensive level; (b) 80 units of therapeutic integration services per week; (c) 60 units of intensive therapeutic integration services per week; (d) 24 units or fewer than 2 units of therapeutic integration or intensive therapeutic integration services for a date of service; (e) 160 units of intensive individual support services per week; (f) 96 units of respite care for a date of service; (g) 1344 units of respite care per State fiscal year; (h) 24 units of family consultation for a date of service; (i) 160 units of family consultation per State fiscal year; (j) A total of $2,104 for environmental accessibility adaptations over a 36-month period; (k) 32 units of intensive individual support services per day; (l) 80 units of adult life planning services per State fiscal year, for participants 14 years old or older; (m) 16 units of adult life planning services per date of service, for participants 14 years old or older; and (n) 15 units of retainer payment per calendar year at either the regular or intensive level when the participant is absent from the residential habilitation program for the purposes of family visitation, hospitalization, or other overnight stays. I. Respite services may not be reimbursed for the same period of the same day as: (1) Residential habilitation; (2) Intensive individual support services; (3) Family consultation; (4) Therapeutic integration; (5) Intensive therapeutic integration; or (6) Adult life planning services. J. The Program does not reimburse transportation costs such as gas, maintenance, or other vehicle operating expenses. K. Adult life planning services under this chapter and school health-related services under COMAR 10.09.50 may not be reimbursed for the same period of the day. L. The Program does not reimburse for any autism waiver services for a participant whose residential placement in a 24-hour, 365-day residential program is funded with non-Medicaid federal, State, or local government funds. #### Regulation .22 Payment Procedures. *COMAR 10.09.56.22* A. Request for Payment. (1) An approved provider shall submit requests for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36.04 or otherwise established by the Program. (2) The provider shall: (a) Bill the Program in accordance with the payment methodology specified in §§D and E of this regulation; (b) Accept payment from the Program as payment in full for the services covered under this chapter and make no additional charge to the participant or any other party for these services; and (c) Submit a request for payment in a manner approved by the Program, which includes the: (i) Date or dates of service; (ii) Participant's name and Medicaid number; (iii) Provider's name, location, and Program identification number; (iv) Type, procedure code or codes, and unit or units of covered services provided; and (v) Amount of reimbursement requested. B. Documentation Required. (1) Payments by the Program or its designee may be withheld if the provider fails to submit requested evidence of services provided, staff qualifications, corrective action plans, or other types of documentation related to ensuring the health and safety of a participant. (2) Payments shall be released upon receipt and approval by the Program or its designee of the requested documentation. (3) An appeal by the provider under COMAR 10.01.03 does not stay the withholding of payments. C. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. D. Payments. (1) Payments shall be made only to a qualified provider for services covered under this chapter which are rendered to a participant. (2) Providers shall be paid the lesser of: (a) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rate established according to the fee schedule published by the Department. E. Rates. (1) The Department shall publish a fee schedule for services covered under this chapter that shall be publicly available and updated at least annually or upon any changes made by the Department. (2) Subject to the limitations of the State budget, the Program’s rates as specified in this regulation shall increase by 4 percent each year through Fiscal Year 2026. (3) Effective July 1, 2022, the Program shall pay according to the following fee-for-service schedule: (a) Residential habilitation services and retainer payments reimbursed at one of the following all-inclusive, maximum rates for a participant: (i) $283.69 per unit for the regular level of service; or (ii) $567.45 per unit for the intensive level of service. (b) Therapeutic integration services reimbursed at the maximum rate of $17.19 per unit. (c) Intensive therapeutic integration services reimbursed at the maximum rate of $21.49 per unit. (d) Intensive individual support services reimbursed at the maximum rate of $21.49 per unit. (e) Respite care reimbursed at the maximum rate of $16.80 per unit. (f) Family consultation reimbursed at the maximum rates of $70.55 per unit. (g) Adult life planning services reimbursed at the maximum rate of $70.55 per unit. (h) Environmental accessibility adaptations reimbursed at the maximum rate of $2,104 per 36-month period amount billed by the provider, which shall be the lesser of the: (i) Amount authorized by the State Department of Education; or (ii) Actual cost of the job. (4) Effective July 1, 2023, the Program shall pay according to the following fee-for-service schedule: (a) Residential habilitation services and retainer payments reimbursed at one of the following all-inclusive, maximum rates for a participant: (i) $283.69 per unit for the regular level of service; or (ii) $567.45 per unit for the intensive level of service. (b) Therapeutic integration services reimbursed at the maximum rate of $8.5950 per unit. (c) Intensive therapeutic integration services reimbursed at the maximum rate of $10.7450 per unit. (d) Intensive individual support services reimbursed at the maximum rate of $10.7450 per unit. (e) Respite care reimbursed at the maximum rate of $8.4000 per unit. (f) Family consultation reimbursed at the maximum rate of $35.2750 per unit. (g) Adult life planning services reimbursed at the maximum rate of $35.2750 per unit. (h) Environmental accessibility adaptions reimbursed at the maximum rate of $2,104 per 36-month period amount billed by the provider, which shall be the lesser of the: (i) Amount authorized by the State Department of Education; or (ii) Actual cost of the job. #### Regulation .23 Recovery and Reimbursement. *COMAR 10.09.56.23* Recovery and reimbursement are set forth in COMAR 10.09.36.07 and include, but are not limited to: A. Providing waiver services without a valid required license or appropriate credentials as required; B. Employing staff or consultants that do not meet conditions for participation in accordance with Regulation .04 of this chapter to provide services to waiver participants; C. Lacking adequate documentation of services that were billed to the Program; D. Submitting claims for services not authorized in the participant's plan of care; and E. Providing services that are not in accordance with the requirements of this chapter and other applicable regulations and law. #### Regulation .24 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.56.24* A. Cause for suspension or removal and imposition of sanctions is set forth in COMAR 10.09.36.08. B. In addition to the sanctions specified at COMAR 10.09.36.08, the Department may limit: (1) The number of participants served by the provider; and (2) The number and type of services provided. #### Regulation .25 Appeal Procedures for Providers. *COMAR 10.09.56.25* Appeal procedures for providers are those set forth in COMAR 10.09.36.09. #### Regulation .26 Appeal Procedures for Applicants and Participants. *COMAR 10.09.56.26* Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04. #### Regulation .27 Interpretive Regulation. *COMAR 10.09.56.27* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 57 — Partially Capitated Programs Authority **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date **Administrative History:** Regulations .01 — .17 adopted as an emergency provision effective June 14, 1995 (22:14 Md. R. 1051); adopted permanently effective October 23, 1995 (22:21 Md. R. 1616) **Administrative History:** Regulation .10I amended effective March 30, 2026 (53:6 Md. R. 291) #### Regulation .01 Definitions. *COMAR 10.09.57.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an entity which submits an application to become a partially capitated provider. (2) “Capitation payment” means the sum of money paid by the Program on behalf of an enrollee on a regular periodic per capita basis for capitated services. (3) “Capitated services” means a service provided by a PCP or one of its subcontractors for which the Department has agreed to pay a capitation payment to the PCP. (4) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Enrollee” means a recipient who has entered into an agreement to receive certain Medical Assistance services from or through a PCP. (6) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (7) “Partially capitated provider (PCP)” means a public or private legal entity which is organized for the purpose of providing or arranging for the provision of medical and health-related services which meets the conditions for participation in Regulations .02 and .03 of this chapter for enrollment and which is eligible to enter into a contract with the Department to receive a capitated payment for a limited number of services. (8) “Program” means the Maryland Medical Assistance Program as defined in COMAR 10.09.36.01. (9) “Provider” means a partially capitated provider. (10) “Provider agreement” means the agreement between the Department and the partially capitated provider which specifies the terms of the relationship between the Department and the provider, and includes the amount of the capitation payment and the specific services to be provided for the capitation payment. (11) “Recipient” has the meaning stated in COMAR 10.09.36.01. #### Regulation .02 Application for Qualification as a Partially Capitated Provider. *COMAR 10.09.57.02* A. An applicant shall demonstrate to the satisfaction of the Department that it has the managerial, financial, clinical, and administrative capability to carry out the duties required by these regulations. B. An applicant shall submit the following documents to the Department along with a completed application form: (1) A narrative of the applicant's overall plan for providing and arranging for the provision of high quality services to enrollees efficiently, effectively, and economically; (2) A description of the organization and staff responsible for delivering health care and a copy of the applicant's organizational documents; (3) An annualized pro forma budget and financial plan for the operation of the organization or, at the Department's option, of the appropriate unit within the organization responsible for the operation for delivery of services pursuant to this regulation for the first 3 years of its anticipated operations which demonstrates its financial viability based on reasonable assumptions; (4) An annualized cash flow chart; (5) A statement of policy and procedures for accounting, methods of reimbursing subcontractors, and payment of emergency and out-of-area claims; (6) Balance sheets; (7) Any other financial information the Program requires; (8) Full and complete information at all times as to the identity of each person or corporation with an ownership or control interest in the PCP and of any subcontractor in which the applicant has a 5 percent or more ownership interest; (9) A detailed description of the applicant's quality assurance plan which demonstrates compliance with Regulation .07 of this chapter; (10) A description of a system for the receipt and prompt adjudication of complaints and grievances by enrollees which complies with Regulation .12 of this chapter; (11) A description of the process by which data about services provided will be collected; (12) Copies of all of the applicant's contracts with subcontractors; (13) A description of the boundaries of the geographic area or area the applicant wishes to serve; and (14) A copy of the applicant's marketing plan. C. If the applicant will be at risk for services it will not directly provide, the applicant shall identify and document a source of funds which will comprise the reserve account required by Regulation .10 of this chapter. #### Regulation .03 Conditions of Participation. *COMAR 10.09.57.03* A. A PCP shall meet the general conditions for participation as set forth in COMAR 10.09.36.03. B. In addition, the PCP shall: (1) Ensure that all of its employees, subcontractors, and employees of its subcontractors are appropriately licensed in the jurisdiction in which they are practicing; (2) Enter into and maintain contractual arrangements necessary to meet the medical and health needs of enrollees for which it is receiving a capitation payment, except for emergency treatment and out-of-area referrals; (3) Accept all Medical Assistance recipients who qualify for the PCP's services who select the PCP and who reside in the PCP's designated geographic area; (4) Allow each enrollee to choose his or her health professionals within the PCP to the extent possible and appropriate; (5) Comply with the requirements of Regulations .05 — .12 of this chapter; (6) Monitor the quality of the services its subcontractors render to its enrollees; (7) Be accessible 24 hours a day to enrollees unless the Program waives this requirement in the provider agreement; (8) Agree to provide services to enrollees as promptly as appropriate; (9) Have a marketing plan which has been approved by the Department and conduct marketing activities in accordance with that plan; and (10) Meet all other applicable requirements of federal and State law. C. In accordance with 42 CFR §434.26(b)(4), an applicant who does not come within one of the exceptions specified in 24 CFR §434.26(b) shall request from the Department a waiver of 42 CFR §434.26(a), which provides that Medicaid recipients and Medicare beneficiaries may constitute not more than 75 percent of the enrollees of a health maintenance organization or prepaid capitation plan. The Department shall pursue a waiver for good cause. #### Regulation .04 Covered Services. *COMAR 10.09.57.04* Providers may be capitated for one of the following packages of services subject to the approval of the Department: A. Inpatient hospital services, as long as the applicant, if regulated by the Health Services Cost Review Commission, has received permission from that agency to receive capitation payments; B. Mental health services, including but not limited to, psychiatric inpatient treatment and community mental health outpatient services; C. Not more than two of the following services or groups of services: (1) Outpatient hospital services, (2) Physician services, (3) Laboratory and X-ray services, (4) Nursing facility services, EPSDT, and family planning services, and (5) Home health services; D. Any service covered by the Program other than a service specified in §A or C of this regulation; E. Inpatient hospital services as listed in §A of this regulation, plus one or more of the services included in §D of this regulation; or F. Not more than two of the services listed in §C of this regulation, plus one or more of the services included in §D of this regulation. #### Regulation .05 Enrollment and Termination of Enrollment. *COMAR 10.09.57.05* A. The Department shall determine the boundaries of the geographic area that a PCP may serve. The Department shall limit enrollment in a PCP to recipients who live in that area. B. The PCP is responsible for the enrollment of recipients who have chosen to enroll in the PCP. C. The PCP shall enter into an enrollment contract with a recipient on the form approved by the Department. D. The PCP shall enroll eligible recipients in the order in which the eligible recipients apply and may not discriminate on the basis of health status in its enrollment, re-enrollment, or disenrollment procedures. E. Termination of enrollment may be initiated by the enrollee, the enrollee's parent, guardian, or legal representative, by the PCP, or by the Department. F. The Department shall approve all terminations of enrollment. #### Regulation .06 Marketing. *COMAR 10.09.57.06* A. The PCP shall specify in its provider agreement the methods by which the PCP will assure the Department that its marketing plans, procedures, and materials are accurate and do not mislead, confuse, or defraud the Department or recipients. B. The Department shall preapprove all marketing plans, procedures, and materials. #### Regulation .07 Quality Assurance. *COMAR 10.09.57.07* A PCP shall maintain an internal quality assurance system based on written policies, standards, and procedures that is in accordance with accepted medical practices and professional standards and that includes, at a minimum, the following: A. A comprehensive quality assurance plan which: (1) Addresses both the quality of clinical care and nonclinical aspects of service such as accessibility, coordination, and continuity of care, (2) Provides for review by physicians and other health professionals of the process followed in the provision of health services, (3) Provides feedback to health professionals and PCP staff regarding performance and patient results, (4) Objectively and systematically monitors and evaluates the quality and appropriateness of care to enrollees through quality of care studies and related activities, and (5) Provides for continuous performance of the activities, including tracking of issues over time; B. A comprehensive utilization management program monitored by the PCP's governing body; and C. A credentialing process for determining whether physicians and other health professionals who are under contract to the PCP are licensed and qualified to perform their services. #### Regulation .08 Record Keeping and Reports. *COMAR 10.09.57.08* A. The PCP shall have an effective procedure for reporting to the Department the following information: (1) The cost of operations; (2) Patterns of utilization; (3) The health status of enrollees; (4) Information demonstrating that the PCP has a fiscally sound operation; and (5) Complaints and grievances made by enrollees. B. The PCP shall collect and submit to the Department service specific encounter data by service type in the format and at the frequency designated by the Department. C. The PCP shall maintain adequate records to document that the services were delivered. D. The PCP shall prepare and submit to the Department quarterly financial and quality assurance reports as specified by the Department. #### Regulation .09 Confidentiality. *COMAR 10.09.57.09* Subject to the requirements of 42 CFR 431F (1994), the PCP and its subcontractors may not release or disclose any information concerning an enrollee except with the written permission of the: A. Department; B. Enrollee; or C. Enrollee's attorney, legal representative, or guardian. #### Regulation .10 Financial Solvency. *COMAR 10.09.57.10* A. The PCP shall include in its provider agreement a clause that the PCP will hold harmless both the Department and its enrollees from any liability for payment for the legal obligations of the PCP. B. The PCP shall give the Department access to the PCP's financial records at reasonable intervals in order to monitor the PCP's financial solvency. C. The PCP shall file annual audited financial statements with the Department. A PCP in operation for less than 1 year shall file an interim statement. D. The provider agreement shall provide for the continuation of benefits to all enrollees for the duration of the contract period for which payment has been made. E. The PCP shall have a financially sound operation as demonstrated by: (1) A positive net worth; and (2) Sufficient cash and adequate liquidity, as determined by the Department, to meet the PCP's obligations as they become due. F. The PCP shall provide full and complete information as to the identity of each person or corporation with an ownership or control interest in the PCP and of any subcontractor in which the PCP has a 5 percent or more ownership interest. G. PCPs that are at risk for services that the PCPs do not directly provide shall deposit an amount equal to the portion of 2 months' capitation payments relating to the services in a reserve account in trust. The agreement establishing the reserve account, which is subject to the Department's approval, may provide that the Department is the sole beneficiary of the trust, and that the trust funds may be disbursed only at the request of the Department to prevent or postpone the PCP's insolvency. H. Minimum Insurance Coverage. (1) The PCP shall provide written evidence to the Department on an annual basis that it has sufficient insurance issued by an insurer authorized by the Maryland Insurance Administrator to engage in the insurance business to protect its financial viability and its ability to carry out its contractual obligations. (2) The coverage shall include at a minimum: (a) Malpractice coverage for all professional and related employees of the provider as well as for the organization itself; (b) Bonding of all employees and officers who have any responsibility for the accounting and financial management activities of the provider; and (c) Workers' compensation, fire, theft, casualty, and other coverage as required by State and local laws. I. PCPs which are governmental units or are funded by the Behavioral Health Administration or the Developmental Disabilities Administration of the Department and subject to the oversight of one of these agencies are exempt from the requirements of this regulation. #### Regulation .11 Subcontracts. *COMAR 10.09.57.11* A. The PCP shall ensure that the following provisions are contained in all subcontracts: (1) A description of the services to be provided by the subcontractor; (2) A description of other activities to be performed by the subcontractor; (3) Providing for release to the PCP of any information necessary for the PCP to perform any of its obligations under its contract with the Department, including but not limited to compliance with the reporting and quality assurance requirements of this chapter; (4) That the facilities and records of the subcontractor shall be open to inspection by the PCP and the Department and that medical records or copies of medical records will be transferred to the PCP upon request upon termination of the subcontractor; (5) That a termination of the subcontract may not be effective without 30 days prior written notice to the Department; (6) That the subcontractor shall look solely to the PCP for compensation for services provided to recipients; (7) The subcontractor shall cooperate with the PCP in implementing the PCP's quality assurance program; and (8) Such other provisions as the Department may reasonably require, taking into consideration the nature of the services to be provided and the requirements of this contract. B. The Department shall preapprove subcontracts. C. A subcontract may not alter or negate the PCP's legal responsibility to the Department under the PCP's provider agreement and this chapter. #### Regulation .12 Internal Grievance Procedure. *COMAR 10.09.57.12* A. The PCP shall have an internal grievance procedure which has been preapproved by the Department. The PCP shall provide a copy of its internal grievance procedures to all enrollees. B. The internal grievance procedure may: (1) Provide for the prompt resolution of any complaints of enrollees or their representatives; (2) Assure the participation of individuals with the authority to require corrective action; and (3) Require that a written record be made of all grievances and complaints by enrollees, and the responses taken by the PCP. C. The PCP shall submit monthly reports to the Department that summarize any grievances and complaints, the actions taken by the PCP in response to the complaints and grievances, and the PCP's plans to address the problems raised in the complaints and grievances. #### Regulation .13 Payment Procedure. *COMAR 10.09.57.13* A. The Department shall pay a PCP a per capita capitation payment for capitated services. B. The Department shall calculate the capitation payment as a percentage of the cost to the Program of providing the same services on a fee-for-service basis to an actuarially equivalent non-enrolled group. #### Regulation .14 Recovery and Reimbursement. *COMAR 10.09.57.14* Recovery and reimbursement under this chapter are as set forth in COMAR 10.09.36.07. #### Regulation .15 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.57.15* Causes for suspension or removal and imposition of sanctions under this chapter are as set forth in COMAR 10.09.36.08. #### Regulation .16 Appeal Procedures. *COMAR 10.09.57.16* Appeal procedures under this chapter are as set forth in COMAR 10.09.36.09. #### Regulation .17 Interpretive Regulation. *COMAR 10.09.57.17* Interpretation of this regulation is subject to COMAR 10.09.36.10. ### Chapter 58 — Family Planning Program **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.12 adopted as an emergency provision effective October 19, 1994 (21:23 Md. R. 1930); adopted permanently effective April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Regulation .01B, C amended as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); amended permanently effective October 13, 2003 (30:20 Md. R. 1448) **Administrative History:** Regulation .01B, C amended effective January 12, 2009 (36:1 Md. R. 21) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686) **Administrative History:** Regulation .01B amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .02B amended effective August 27, 2007 (34:17 Md. R. 1507) **Administrative History:** Regulation .02B amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) **Administrative History:** Regulation .02B amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .03 amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .04 amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .04D adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) **Administrative History:** Regulation .05A, D, E amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .05F amended effective January 12, 2009 (36:1 Md. R. 21); March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .05F amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) **Administrative History:** Regulation .05G amended effective March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .05H adopted effective March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .06 amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .06A amended effective August 27, 2007 (34:17 Md. R. 1507); March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .06A amended as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); amended permanently effective June 11, 2012 (39:11 Md. R. 686) **Administrative History:** Regulation .07 amended effective June 11, 2012 (39:11 Md. R. 686); December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .10 repealed and new Regulation .10 adopted as an emergency provision effective January 1, 2012 (39:2 Md. R. 139); adopted permanently effective June 11, 2012 (39:11 Md. R. 686) #### Regulation .01 Purpose and Scope. *COMAR 10.09.58.01* A. This chapter governs the coverage of services for the Medical Assistance Family Planning Program. B. Eligibility shall be established according to COMAR 10.09.37. #### Regulation .02 Definitions. *COMAR 10.09.58.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advanced practice nurse” means an individual who meets the requirements in COMAR 10.09.01. (2) “Department” means the Maryland Department of Health as defined in COMAR 10.09.36.01. (3) “Early and Periodic Screening, Diagnostic and Treatment (EPSDT)” means the provision to individuals younger than 21 years old, of preventative health care under 42CFR §441.50 et seq. as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects and physical and mental illnesses and conditions discovered by EPSDT screening services. (4) “Family planning” means providing individuals with the information and means to prevent unwanted pregnancy and maintain reproductive health. (5) “Free-standing clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home, and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. (6) “Hospital” means an institution that is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the service is provided. (7) “Local health department (LHD)” means the Baltimore City Health Department and its subgrantees, or a county health department and its subgrantees. (8) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (9) “Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease. (10) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (11) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (12) “Participant” means an individual who is certified as eligible for the Family Planning Program as described in COMAR 10.09.37. (13) “Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland, or similar establishment or institution which is legally authorized to dispense legend drugs to the public in the state in which the establishment or institution is located. (14) “Physician” means an individual licensed to practice medicine in the state in which the physician's practice is located. (15) “Physician assistant” means an individual who meets the requirements in COMAR 10.09.55. (16) “Physician office and other point-of-care laboratory” means a medical laboratory at a site or facility operated as a part of, or in association with, the medical practice of licensed medical practitioners permitted to perform clinical laboratory procedures, community health center, emergency treatment center, health maintenance organization, or county or local health department, where clinical laboratory procedures are performed for patients seen by the practitioner or a practitioner employed or otherwise engaged by one of these entities. (17) “Program” means the Maryland Medical Assistance, Family Planning Program. (18) “Provider” means a health care provider who: (a) Meets the licensure requirements set forth in Regulation .03 of this chapter; (b) Meets the conditions for participation set forth in Regulation .04 of this chapter; and (c) Provides the services described in Regulation .05 of this chapter. #### Regulation .03 Licensure Requirements. *COMAR 10.09.58.03* A. An advanced practice nurse shall be licensed to practice as described in COMAR 10.09.01. B. A doctor of medicine or osteopath shall be licensed and legally authorized to practice medicine in the state in which the service is delivered as described in COMAR 10.09.02. C. A physician assistant must be licensed to practice as described in COMAR 10.09.55. D. Medical laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located: (1) In Maryland or out-of-State with representation or specimen pick-up in Maryland, comply with the requirements of Health-General Article, §§17-202, 17-212, and 17-214.1, Annotated Code of Maryland, and COMAR 10.10.01; or (2) Out-of-State without representation or specimen pick-up in Maryland, comply with other applicable standards established by the state and locality in which the services are provided. E. A pharmacy may not qualify as a provider without first having obtained a permit from the: (1) Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or (2) Appropriate agency in the state in which the pharmacy is located. F. Physician office and other point-of-care laboratories shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and, if located: (1) In Maryland, comply with the requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or (2) Out-of-State, comply with other applicable standards established by the state and locality in which the services are provided. #### Regulation .04 Conditions of Participation. *COMAR 10.09.58.04* A. Providers shall be enrolled as Medical Assistance Program providers and shall meet the requirements for participation in the Maryland Medical Assistance Program as set forth in COMAR 10.09.36.03, as well as the requirements for participation as set forth in the COMAR chapter defining the provider and covered service being rendered. B. Services covered in Regulation .05A—C of this chapter shall be provided by: (1) A physician; (2) An advance practice nurse; or (3) A physician assistant. C. Providers shall accommodate the cultural and ethnic diversity of the populations to be served. #### Regulation .05 Covered Services. *COMAR 10.09.58.05* The following services are covered under this chapter: A. Office medical visits for the primary purpose of providing age and sex appropriate family planning services, which include: (1) Focused history, physical exam, and laboratory testing necessary to evaluate and manage the participant’s choice of chemical, mechanical, or other method to prevent conception; (2) Basic education regarding human sexuality and reproduction; (3) Advice and counseling regarding all family planning methods, including natural family planning measures and sterilization procedures, the availability and effectiveness of methods, procedures involved in each, and untoward effects and potential complications of each method; and (4) Referral mechanism and documented referral for all patients demonstrating illness, disease, or pregnancy; B. Specimen collection by venipuncture or capillary puncture when performed by either the medical practitioner or the laboratory; C. Pregnancy test if indicated by physical examination or history, or both, when performed by either the medical practitioner or the laboratory; D. The following laboratory tests: (1) Hemoglobin or hematocrit, or both; (2) Urinalysis for albumin sugar; (3) Urine culture and sensitivity studies; (4) Appropriate laboratory tests to screen for sexually transmitted infections; (5) Smear wet mount and KOH with interpretation; (6) Rubella titer of females without documentation of prior rubella immunization; and (7) Pap smear; E. Pharmaceutical supplies and devices: (1) To prevent conception through chemical, mechanical, or other methods, which are covered by the Maryland Medical Assistance Program under COMAR 10.09.03.04; and (2) To treat sexually transmitted infections when diagnosed during the course of an office visit, as outlined in §A of this regulation, which are covered under COMAR 10.09.03.04 except treatment for: (a) Human immunodeficiency virus; and (b) Hepatitis. F. Permanent sterilization only when performed according to criteria in 42 CFR Part 441, Subpart F, Sterilizations, as amended, and when the appropriate forms are: (1) Properly completed; and (2) Available in the medical record for review; G. Human papillomavirus vaccine; and H. Abortions performed in accordance with Health-General Article, §15-103, Annotated Code of Maryland. #### Regulation .06 Limitations. *COMAR 10.09.58.06* A. The following services are not covered: (1) Services not medically necessary; (2) Transportation services; (3) EPSDT services; (4) Services delivered in an in-patient hospital setting or ambulatory surgical center other than: (a) Permanent sterilizations; and (b) A hysterosalpingogram following the Essure procedure; (5) Infertility services, including reversal of sterilization; and (6) Any service not listed in Regulation .05 of this chapter. B. Limitations for advanced practice nurse services covered under this chapter are those set forth in COMAR 10.09.01.05. C. Limitations for physician services covered under this chapter are those set forth in COMAR 10.09.02.05. D. Limitations for free-standing clinic services covered under this chapter are those set forth in COMAR 10.09.08.07. E. Limitations for pharmacy services covered under this chapter are those set forth in COMAR 10.09.03.05. F. Limitations for medical laboratory services covered under this chapter are those set forth in COMAR 10.09.09.05. G. Limitations for acute hospital services covered under this chapter are those set forth in COMAR 10.09.92.05. H. Limitations for physician assistant services covered under this chapter are those set forth in COMAR 10.09.55.05. I. Limitations for ambulatory surgery centers covered under this chapter are those set forth in COMAR 10.09.42.05. #### Regulation .07 Payment Procedures. *COMAR 10.09.58.07* A. Payment procedures are those set forth in COMAR 10.09.36.04. B. Billing time limitations are those set forth in COMAR 10.09.36.06. C. Payment procedures for advanced practice nurses are those set forth in COMAR 10.09.01.06. D. Payment procedures for physician services in the office or home are those set forth in COMAR 10.09.02.07. E. Payment procedures for clinic services delivered in federally qualified health centers are those set forth in COMAR 10.09.08.05. F. Payment procedures for clinic services delivered in local health departments, family planning clinics, and other free-standing clinics are those set forth in COMAR 10.09.02.07. G. Payment procedures for pharmacy services are those set forth in COMAR 10.09.03.07. H. Payment procedures for medical laboratory services are those set forth in COMAR 10.09.09.07. I. Payment procedures for acute hospital services are those set forth in COMAR 10.09.92.07. J. Payment procedures for physician assistant services are those set forth in COMAR 10.09.55.06. K. Payment procedures for ambulatory surgery centers are those set forth in COMAR 10.09.42.06. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.58.08* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.58.09* Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.58.10* The requirements related to appeal procedures under COMAR 10.09.36 and 10.09.37 apply to this chapter. #### Regulation .11 Fraud and Abuse. *COMAR 10.09.58.11* The requirements relating to fraud and abuse under COMAR 10.09.24.14 shall apply to this chapter. #### Regulation .12 Interpretive Regulation. *COMAR 10.09.58.12* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 59 — Specialty Mental Health Services **Authority:** Health-General Article, §§2-104(b), 2-105(b), 15-102.8, 15-103, 15-105, and 15-105.2, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective February 3, 1995 (22:4 Md. R. 232); adopted permanently effective June 5, 1995 (22:11 Md. R. 821) **Administrative History:** Regulations .01 and .03—.07 amended as an emergency provision effective July 1, 1997 (24:18 Md. R. 1291); emergency status expired December 31, 1997; amended permanently effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .04 amended effective February 12, 1996 (23:3 Md. R. 168) **Administrative History:** Regulation .05 amended effective February 12, 1996 (23:3 Md. R. 168); August 10, 1998 (25:16 Md. R. 1274) **Administrative History:** Regulation .07K—M amended effective August 10, 1998 (25:16 Md. R. 1274) **Administrative History:** Regulations .01—.11 under, Rehabilitation and Other Mental Health Services, repealed and new Regulations .01—.14 under, Specialty Mental Health Services, adopted effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .01B amended effective October 26, 2015 (42:21 Md. R. 1300); October 10, 2016 (43:20 Md. R. 1110); May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .03 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420); December 31, 2018 (45:26 Md. R. 1243); May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .04B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .04B, D amended effective October 10, 2016 (43:20 Md. R. 1110) **Administrative History:** Regulation .05 repealed and new Regulation .05 adopted effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .05 amended effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .05B, C amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1300); May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .06C amended effective October 10, 2016 (43:20 Md. R. 1110) **Administrative History:** Regulation .07 amended effective October 26, 2015 (42:21 Md. R. 1300); April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .07D, K, N amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .07V amended effective December 31, 2018 (45:26 Md. R. 1243) **Administrative History:** Regulation .08 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .09 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .09F amended effective May 12, 2025 (52:9 Md. R. 405) **Administrative History:** Regulation .09I adopted effective April 23, 2018 (45:8 Md. R. 420) **Administrative History:** Regulation .12 amended effective October 26, 2015 (42:21 Md. R. 1300) **Administrative History:** Regulation .13 amended effective October 26, 2015 (42:21 Md. R. 1300) #### Regulation .01 Definitions. *COMAR 10.09.59.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative services organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System. (2) “Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department. (3) “Definitive drug test” means a drug screening test that includes: (a) The ability to identify individual drugs and distinguish between structural isomers, but not necessarily stereoisomers, using gas chromatography or mass spectrometry and liquid chromatography or mass spectrometry; (b) Qualitative or quantitative results; (c) All source types for specimen selection; and (d) Specimen validity testing, per day, 1—22 or more drug classes including metabolites, if performed. (4) “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. (5) “Hospital” means an institution which: (a) Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (b) Is licensed under COMAR 10.07.01 or is licensed by the state in which the service is provided. (6) “Individualized education program (IEP)” has the meaning stated in COMAR 10.09.50.01. (7) “Individualized Family Service Plan (IFSP)” has the meaning stated in COMAR 10.09.50.01. (8) “Local school system (LSS)” means a local public school district. (9) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. (10) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (11) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (12) “Participant” means an individual who is certified as eligible for, and is receiving, medical assistance benefits. (13) “Presumptive drug test” means a drug screening test that includes: (a) Any number of drug classes; (b) Any number of devices; (c) The use of direct optical observation, instrument assisted direct optical observation or instrumented chemistry analyzers; and (d) Sample validation. (14) “Program” has the meaning stated in COMAR 10.09.36.01. (15) “Provider” means an organization or an individual practitioner furnishing the services covered under this chapter which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a provider account number. (16) “Public Behavioral Health System” means the system that provides medically necessary behavioral health services, including mental health and substance use disorder services, for Medical Assistance participants and certain other uninsured individuals. (17) “Specialty mental health services” means services for which a participant’s diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter. #### Regulation .02 License Requirements. *COMAR 10.09.59.02* To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02. #### Regulation .03 General Conditions for Provider Participation. *COMAR 10.09.59.03* To participate in the Program, a provider shall: A. Meet the conditions for provider participation in the Medical Assistance Program as set forth in COMAR 10.09.36.03; B. Meet the conditions for licensure and practice as set forth in COMAR 10.63.01, 10.63.02, and 10.63.06; C. Have clearly defined and written patient care policies; and D. Maintain, either manually or electronically, adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, meets the following requirements: (1) Includes the date of service with service start and end times; (2) Includes the participant’s primary behavioral health complaint or reason for the visit; (3) Includes a brief description of the service provided, including progress notes; (4) Includes an official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate title; (5) Is made available to the following as requested: (a) The Department; (b) The ASO; (c) The Core Service Agency; (d) The Office of Inspector General; and (e) The Office of the Attorney General Medicaid Fraud Control Unit; and (6) Is consistent with the medical records confidentiality and disclosure requirements of: (a) Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (b) Relevant federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164. #### Regulation .04 Provider Requirements for Participation. *COMAR 10.09.59.04* A. Individual Practitioner Providers. To participate in the Program as an individual practitioner of specialty mental health services, the provider shall: (1) Be licensed and legally authorized to practice independently by the appropriate Board to practice in the state in which the service is rendered; and (2) Demonstrate, by training and experience, the competency to provide mental health services as one of the following: (a) A licensed certified social worker-clinical; (b) A nurse psychotherapist (APRN-PMH); (c) A pediatric nurse practitioner with a PMHS; (d) A nurse practitioner-psychiatric (CRNP-PMH); (e) A physician who demonstrates the competency to provide specialty mental health services; (f) A licensed certified counselor which includes: (i) A licensed clinical professional counselor; (ii) A licensed clinical marriage and family therapist; (iii) A licensed clinical counselor-alcohol and drug; or (iv) A licensed clinical professional art therapist; (g) A psychiatrist certified by the American Board of Psychiatry and Neurology or possessing the minimum educational and training requirements to take the Board of Psychiatry and Neurology examination for certification in psychiatry; or (h) A psychologist. B. Community Mental Health Program Providers. To participate in the Program as a community-based mental health program provider, the provider shall be approved under COMAR 10.63.01, 10.63.02, and 10.63.06 and possess licensure by the Behavioral Health Administration as: (1) A psychiatric rehabilitation program serving adults in compliance with COMAR 10.63.03.09; (2) A psychiatric rehabilitation program serving minors in compliance with COMAR 10.63.03.10; (3) A mobile treatment program, which shall: (a) Comply with COMAR 10.63.03.04; (b) Consist of a multidisciplinary team including, at a minimum: (i) A program director that is a mental health professional; (ii) A psychiatrist or psychiatric nurse practitioner (CRNP-PMH); (iii) A licensed registered nurse; (iv) At least one licensed social worker or licensed graduate social worker; and; (v) At least one mental health professional who may include the staff identified in §B(3)(b)(iii) and (iv) of this regulation; and (c) Maintain sufficient staffing to fulfill the following service requirements including: (i) Initial and continuing psychiatric evaluation, diagnosis, and individual treatment planning; (ii) Medication services; (iii) Independent living skills assessment and training; (iv) Health promotion and training; (v) Interactive therapies; (vi) Crisis intervention services; and (vii) Support, linkage, and advocacy; or (4) An outpatient mental health clinic in compliance with: (a) COMAR 10.63.03.05; and (b) Staffing requirements as described in COMAR 10.63.03.05 and including: (i) A program director who is a licensed mental health professional or has a master’s degree in a related field and is employed by the OMHC and is on-site at the organization for at least 20 hours per week; (ii) A medical director as described in COMAR 10.63.03.05 and is serving the organization for at least 20 hours per week; (iii) A multidisciplinary licensed mental health professional staff as described in COMAR 10.63.03.05, including representatives of two different mental health professions, each of whom shall be on-site 50 percent of the OMHC’s regularly scheduled hours; (iv) Graduate level students and interns, who may deliver services under supervision of a licensed mental health professional and when a licensed mental health professional co-signs all documentation of contact with participants. C. Federally Qualified Health Centers. To participate in the Program as a Federally Qualified Health Center, the provider shall be in compliance with COMAR 10.09.08. D. Other Licensed or Approved Mental Health Providers. To participate in the Program as a specialty mental health provider not defined in §§A—C of this regulation, a provider shall be approved pursuant to COMAR as a: (1) Targeted case management provider in compliance with: (a) If serving children, COMAR 10.09.90; and (b) If serving adults, COMAR 10.09.45; (2) Residential treatment center in compliance with COMAR 10.07.04 and 10.09.29; (3) Hospital in compliance with COMAR 10.09.92—10.09.95; (4) Non-hospital-based mental health psychiatric day treatment provider in compliance with: (a) COMAR 10.63.03.08; (b) Staffing requirements described in 10.63.03.08 and including: (i) A multidisciplinary team employed at least on a part-time basis; and (ii) A program director; (c) Service requirements as described in 10.63.03.08 and including: (i) An individual treatment plan developed by the multi-disciplinary team within 4 working days of admission; (ii) Psychopharmacological treatment; (iii) Occupational therapy; (iv) Activity therapy; and (v) Other necessary medical, psychological, and social services; and (d) COMAR 10.05.01.11 for requirements of the physical environment; (5) 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families Waiver provider in compliance with COMAR 10.09.89; (6) Therapeutic behavioral service provider in compliance with COMAR 10.09.34; (7) Medical laboratory in compliance with COMAR 10.09.09; or (8) Local school systems in compliance with COMAR 10.09.50 as a provider of school-based health-related services. #### Regulation .05 Eligibility. *COMAR 10.09.59.05* A. A participant is eligible for specialty mental health services if: (1) The individual meets the Department’s medical necessity criteria; and (2) The service is appropriate to the specific provider type or community-based mental health provider listed in Regulation .04 of this chapter. B. Individuals are eligible for Psychiatric Rehabilitation Programs for adults if the individual: (1) Has been referred for psychiatric rehabilitation program services by a licensed mental health professional who: (a) Is enrolled as a provider in the Program with an active status on the date of service; (b) Facilitates an informed choice of psychiatric rehabilitation program providers; and (c) Currently provides inpatient, residential treatment center, or outpatient mental health services to the individual; (2) Has a diagnosis listed in COMAR 10.67.08.02N; and (3) Is in need of program services in order to improve or restore independent living and social skills necessary to support the individual’s recovery, ability to make informed decisions and choices, and participation in community life. C. Individuals are eligible for Psychiatric Rehabilitation Programs for minors if the individual: (1) Has been referred for psychiatric rehabilitation program services by a licensed mental health professional who: (a) Is enrolled as a provider in the Program with an active status on the date of service; (b) Facilitates an informed choice of psychiatric rehabilitation program providers; and (c) Currently provides inpatient, residential treatment center, or outpatient mental health services to the minor; (2) Is currently in, and remains in, active mental health treatment; (3) Has the appropriate consent to participate in psychiatric rehabilitation program services; (4) Has a diagnosis listed in COMAR 10.67.08.02N and severe functional impairments in at least one life domain; (5) With psychiatric rehabilitation program services, is expected to have reduced symptoms of their mental illness or functional behavioral impairment as a result of their mental illness based on the clinical evaluation and ongoing treatment plan; and (6) Is at risk of requiring a higher level of care, or is returning from a higher level of care. D. Individuals are eligible for Mobile Treatment Services if it is assessed that the individual will benefit from mobile treatment services and the individual is: (1) Experiencing homelessness; (2) Unable or unwilling to use, on a continuing basis, community-based mental health services that are prescribed for the individual; or (3) In an institution or inpatient facility and would be able to reside in a community setting if the individual received MTS and other appropriate support services. #### Regulation .06 Covered Services. *COMAR 10.09.59.06* A. The ASO shall reimburse the following specialty mental health services rendered to participants when authorized by the ASO: (1) Medically necessary specialty mental health services delivered by providers listed in Regulation .04 of this chapter, for which the primary diagnosis is listed in COMAR 10.67.08.02M or N; (2) Telehealth services as defined in COMAR 10.09.49 when rendered in accordance with limitations in Regulation .07 of this chapter; and (3) Presumptive drug tests and definitive drug tests, when ordered by a specialty mental health provider, with a behavioral health primary diagnosis listed in COMAR 10.67.08.02M or N on the claim. B. Specialty mental health services billed by local school systems are covered under the following conditions: (1) The services are not furnished as part of an individualized education program or individualized family service plan) as defined in COMAR 10.09.50.01; and (2) The services are rendered by a school psychologist or school social worker that meets the qualifications described in COMAR 10.09.50.02. #### Regulation .07 Limitations. *COMAR 10.09.59.07* The Program does not cover the following: A. Services not delivered in compliance with the COMAR references listed in Regulations .04 and .05 of this chapter; B. Services not medically necessary; C. Investigational or experimental drugs and procedures; D. Specialty mental health services for participants in an institution for mental disease as defined in 42 CFR §435.1009 unless the service is delivered through the §1115 HealthChoice Demonstration Waiver; E. Specialty mental health visits solely for the purpose of: (1) Prescribing medication; (2) Administering medication; (3) Drug or supply pick-up; (4) Collecting laboratory specimens; (5) Interpreting laboratory tests or panels; or (6) Administering injections, unless the following are documented in the participant’s medical record: (a) Medical necessity; and (b) The participant’s inability to take appropriate oral medications; F. Separate reimbursement to an employee of a program for services that have been provided by and reimbursed directly to a program; G. Vocational counseling, vocational training at a classroom or job site, and academic or remedial educational services; H. Services provided to or for the primary benefit of individuals other than the participant; I. Outpatient Mental Health Clinic services delivered to a participant with a primary diagnosis of substance use disorder, unless the claim reflects a secondary diagnosis of mental health; J. An on-site psychiatric rehabilitation program visit by a participant on the same day that the participant receives medical day care services under COMAR 10.09.07; K. Psychiatric rehabilitation program services rendered via telehealth when: (1) They are rendered as a group service; or (2) The total services rendered via telehealth comprise more than 50 percent of a participant’s services rendered; L. Non-emergency services not authorized by the ASO; M. Mental health services delivered by a primary care provider and reimbursed through Medicaid Fee for Service or the Maryland Medicaid Managed Care Program; N. Services delivered by Federally Qualified Health Centers other than those billed using the T-code or H-code, which may include the following, delivered by two separate but appropriately licensed providers: (1) One T-code for mental health services per day; and (2) One H-code for substance use disorder services per day; O. Supported employment services provided by a community-based psychiatric rehabilitation program, except in cases of clinic coordination; P. Residential crisis services; Q. Respite care services, other than those provided through the 1915(i) Intensive Behavioral Health Services program described in COMAR 10.09.89; R. Services provided to participants in a hospital inpatient setting, with the exception of services delivered by: (1) Physicians; and (2) Nurse Practitioners; S. Housing services; T. Services rendered but not appropriately documented; U. Services reimbursed by the ASO not included in this chapter; V. Mobile Treatment or ACT Services without a minimum of four in-person services provided per month; W. Services rendered by community based specialty mental health programs with an immediate family member of an employee of the program serving on the governing body, board of directors, or advisory committee, whichever applies; and X. Psychiatric rehabilitation services referred by: (1) An individual who is not enrolled as a provider in the Program with an active status on the date of service; and (2) An entity, facility, or another provider that is not an individual. #### Regulation .08 Authorization Requirements. *COMAR 10.09.59.08* A. The ASO shall establish a process, through a utilization review system, for authorization of specialty mental health services. B. The ASO shall authorize services that are: (1) Medically necessary; (2) Of a type, frequency, and duration that are consistent with expected results and cost-effective; and (3) Delivered in a manner consistent with this chapter. C. Preauthorization is not required before a provider renders services in an emergency department. D. Except as provided in Regulation .08C of this chapter, no payment shall be rendered for services that have not been authorized. #### Regulation .09 Payment Procedures. *COMAR 10.09.59.09* A. Payment procedures shall be followed as specified in COMAR 10.09.36.04. B. A provider shall deliver and document services in accordance with Department regulations in order to receive reimbursement. C. Unless the care is free to other patients, a provider shall bill the Program its usual and customary charge to the general public. D. The Department shall authorize supplemental payment on Medicare claims only if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that the services are medically necessary; (4) The services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. E. The Department shall make payment on Medicare claims subject to the following provisions: (1) Deductible and coinsurance shall be paid in full for services designated as mental health services by Medicare; and (2) The Program shall reimburse services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of this chapter. F. A provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail or telehealth, unless the services are provided in compliance with COMAR 10.09.49; or (4) Services not authorized consistent with Regulation .08 of this chapter. G. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. H. The Department shall reimburse providers according to the fee schedule in COMAR 10.21.25. I. Psychiatric rehabilitation programs shall identify the mental health professional who referred the individual to psychiatric rehabilitation services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim. #### Regulation .10 Recovery and Reimbursement. *COMAR 10.09.59.10* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .11 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.59.11* Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. #### Regulation .12 Appeal Procedures for Providers. *COMAR 10.09.59.12* Appeal procedures for providers are as set forth in COMAR 10.09.36.09. #### Regulation .13 Appeal Rights — Denial of Services. *COMAR 10.09.59.13* Appeal procedures for applicants and participants are as set forth in COMAR 10.01.03 and 10.01.04. #### Regulation .14 Interpretive Regulation. *COMAR 10.09.59.14* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 60 — Senior Prescription Drug Assistance Program **Authority:** Health-General Article, §15-1005(b)(1), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Chapter recodified from 31.17.04 Senior Prescription Drug Assistance Program, to 10.09.60 Senior Prescription Drug Program effective July 1, 2016 **Administrative History:** Regulation .01B amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .02D amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .03 amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .04A, B amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .05B amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .06 amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .07 amended effective February 13, 2017 (44:3 Md. R. 188) **Administrative History:** Regulation .08 amended effective February 13, 2017 (44:3 Md. R. 188) #### Regulation .01 Definitions. *COMAR 10.09.60.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrator” means the third party that contracts with the Department to administer the Program. (2) “Annual household income” has the meaning stated in Regulation .02B of this chapter. (3) “Department” means the Maryland Department of Health. (4) “Eligible individual” means an individual who meets the criteria set forth in Regulation .02A of this chapter: (5) “Enrollee” means an individual enrolled in the Senior Prescription Drug Assistance Program. (6) “Household member” means: (a) An eligible individual; (b) The spouse of an eligible individual if the spouse resides in the same residence as the eligible individual; and (c) An individual who: (i) Is related to an eligible individual by blood, marriage, or adoption; (ii) Resides in the same residence as the eligible individual; and (iii) Is dependent on the eligible individual or the spouse of the eligible individual for at least one-half of the individual's support. (7) “Prescription drug plan sponsor” means a nongovernmental entity that is certified by the Centers for Medicare and Medicaid Services as meeting the requirements of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 for offering in the State: (a) A Medicare Part D prescription drug plan; or (b) A Medicare Advantage Plan that provides prescription drug benefits. (8) “Program” means the Senior Prescription Drug Assistance Program established under Health-General Article, Title 15, Subtitle 10, Annotated Code of Maryland. (9) “Program Fund” means the Fund established under Insurance Article, §15-1004, Annotated Code of Maryland. (10) “Reasonable administrative expenses” means administrative expenses including, but not limited to, marketing, advertising, mailing, printing, and fully allocated costs for administration of the Program. (11) Support and Maintenance Furnished in-Kind. (a) “Support and maintenance furnished in-kind” means any food or shelter that is: (i) Given to an eligible individual or the spouse of an eligible individual without cost; or (ii) Received by an eligible individual or the spouse of an eligible individual because another person has paid the cost. (b) “Support and maintenance in-kind” includes the provision of room, rent, garbage collection services, mortgage payments, real property tax payments, and heating fuel, gas, electricity, water, and sewage payments. #### Regulation .02 Eligibility, Enrollment, and Disenrollment. *COMAR 10.09.60.02* A. To be eligible for enrollment in the Program, an individual shall: (1) Be a resident of Maryland; (2) Be a Medicare beneficiary enrolled in the Medicare Part D Voluntary Prescription Drug Benefit Program or a Medicare Advantage Plan that provides Part D coverage; (3) Have an annual household income, as described in §B of this regulation, at or below 300 percent of the Federal Poverty Guidelines that apply to the individual based on the number of household members of the individual; (4) Not be enrolled in a health benefit plan, other than a Medicare Part D prescription drug plan or a Medicare Advantage Plan, that provides prescription drug benefits at the time the individual applies for enrollment in the Program; and (5) Not be eligible for a full federal low-income subsidy under 42 CFR §423.772. B. Consideration of Annual Household Income. (1) Annual household income to be considered in determining financial eligibility is both earned and unearned income of the applicant and spouse who reside in the same residence, projected for a 12-month period beginning with the month in which the person submits the application for enrollment in the Program. (2) Earned income includes: (a) Wages, commissions, fees, profit from self-employment, salaries, and tips; (b) The value of nonmonetary compensation received for services rendered; and (c) Profit from rent received from a roomer, tenant, or boarder. (3) Unearned income includes: (a) Payment from unemployment insurance, the Family Investment Program, the Supplemental Security Income Program, Veteran's and Workers' Compensations, private insurance, Black Lung Program, Railroad Retirement, Social Security, pensions, annuities, and other regular benefits received; (b) Except as provided in §B(4) of this regulation, support from absent relatives, support from legally responsible relatives, and income which is received on a regular basis from relatives and friends who are not legally responsible; (c) Parental income received by a child as support from his natural or adoptive parents or putative father; and (d) Income from assets received as either interest, dividends, or other income from savings accounts, certificates, stocks, bonds, insurance policies, mortgages, and from real property that is not included as earned income. (4) Unearned income does not include support and maintenance furnished in-kind. C. An eligible individual may apply for enrollment in the Program by submitting a completed application to the Administrator. D. Maximum Capacity of Program. (1) The Administrator may not enroll additional individuals at a time when the Program's total enrollment reaches the level authorized by the Department. (2) The Program shall maintain a waiting list of individuals who meet the eligibility requirements for the Program but who are not served by the Program because of funding limitations. (3) If, after the Program reaches its maximum capacity as established by the Department, the number of individuals enrolled decreases, the Administrator may recommence enrolling eligible individuals in the Program as specified in this regulation, until the Program's enrollment again reaches the authorized maximum. (4) The Department may direct the Administrator to limit enrollment based on the amount of money remaining in the Program Fund. E. Disenrollment. (1) The Administrator may, after first providing reasonable notice to the enrollee, disenroll from the Program an enrollee for any of the causes specified in §E(2) of this regulation. (2) An enrollee may be disenrolled from the Program if the enrollee: (a) Ceases to meet the eligibility criteria set forth in §A of this regulation; or (b) Is enrolled in: (i) A Medicare Part D prescription drug plan that does not charge a premium; or (ii) A Medicare Advantage Plan that does not charge a premium for prescription drug coverage. #### Regulation .03 Outreach Program. *COMAR 10.09.60.03* A. The Department shall develop and implement an outreach program targeted at eligible individuals. B. The Department shall publicize the existence and eligibility requirements of the Program through the following entities: (1) The Department of Aging; (2) Local health departments; (3) Continuing care retirement communities; (4) Places of worship; (5) Civic organizations; (6) Community pharmacies; and (7) Any other entity that the Department determines is appropriate. C. The Department of Aging, through its Senior Health Insurance Program, shall: (1) Assist eligible individuals in applying for coverage under the Program; and (2) Provide notice of the Program and its eligibility requirements to potentially eligible individuals who seek health insurance counseling services through the Department of Aging. D. The Department shall ensure that the entities used to publicize the existence of the Program under §B of this regulation, have sufficient Program applications and enrollment materials for distribution. E. Mail-In Application. (1) The Department shall develop a mail-in application for the Program. (2) The Administrator shall make available mail-in applications to eligible individuals. F. Any outreach performed by the Department on behalf of the Program shall be funded through the Program Fund. #### Regulation .04 Administrator. *COMAR 10.09.60.04* A. Administrator Contract. The Administrator and the Department shall execute an Administrator contract specifying the terms under which the Administrator shall operate the Program, including but not limited to an agreement by the Administrator to: (1) Provide the prescription drug benefit subsidies described in Regulation .06 of this chapter; (2) Submit a detailed quarterly financial accounting of the Program, including the identification of all revenue and cost items to the Department; (3) Develop and implement a marketing plan designed to notify eligible individuals throughout the State of the existence and eligibility criteria for the Program; and (4) Collect and submit to the Department, data regarding the costs for program enrollees. B. Program Operation. The Administrator shall operate the Program in a manner consistent with: (1) The terms of this chapter; (2) The Administrator contract governing operation of the Program that is executed between the Department and the Administrator; and (3) All applicable federal and State law. C. Prescription Drug Benefit Subsidies. The Administrator shall pay to prescription drug plan sponsors the subsidy payments that the Program has agreed to make on behalf of member enrollees of the prescription drug plan sponsors. #### Regulation .05 Program Description Booklet. *COMAR 10.09.60.05* A. The Administrator shall develop a Program description booklet. B. The Program description booklet is subject to approval by the Department. C. The Program description booklet shall describe the essential features of the Program including: (1) Eligibility requirements; (2) A listing of available prescription drug plans and details of the prescription drug plans; (3) Termination provisions; (4) Appeal procedures; (5) Other Program guidelines; and (6) All other terms, conditions, and limitations of the Program. #### Regulation .06 Prescription Drug Benefit Subsidy. *COMAR 10.09.60.06* A. The Program shall: (1) Provide a prescription drug benefit subsidy, as determined by the Department, that may pay all or some of the deductibles, coinsurance payments, premiums, and copayments under the federal Medicare Part D Pharmaceutical Assistance Program for enrollees of the Program; and (2) Provide the subsidy to the maximum number of individuals eligible for enrollment in the Program, subject to the money available in the Program Fund. B. The Program may annually provide an additional subsidy, up to the full amount of the Medicare Part D Prescription Drug Plan premium, for individuals who qualify for a partial federal low-income subsidy. C. The Department shall determine annually: (1) The number of individuals to be enrolled in the Program; (2) The amount of subsidy to be provided under §A of this regulation; and (3) The amount of any additional subsidy provided under §B of this regulation. #### Regulation .07 Contracts with Prescription Drug Plan Sponsors. *COMAR 10.09.60.07* A. The Department may enter into contracts with prescription drug plan sponsors who have been approved by the Centers for Medicare and Medicaid Services to offer Medicare Part D plans in the State. B. A prescription drug plan sponsor that enters into a contract with the Department shall agree to perform its obligations in a manner that complies with: (1) Medicare Part D and any federal regulations adopted to implement Medicare Part D; (2) The Program; (3) The terms and conditions of the contract; and (4) Guidance from the Centers for Medicare and Medicaid Services. C. A contract entered into with the Department shall include provisions that require the prescription drug plan sponsor to: (1) Coordinate with the Program in identifying member enrollees; (2) Accept the premium subsidy on behalf of member enrollees; (3) Apply the premium subsidy to the member enrollee's total premium costs; (4) Separately bill member enrollees for any premium owed in excess of the premium subsidy paid by the Program; (5) Account for the subsidies received from the Program; (6) Communicate in writing with member enrollees, including notifying member enrollees of their enrollment status; (7) Share enrollment data and information with the Department; (8) Report data and enrollment information as required by the Department; (9) Reconcile Program and member payments with enrollment data; and (10) Transmit information to appropriate third-parties, including the Administrator and the Centers for Medicare and Medicaid Services. #### Regulation .08 Program Fund. *COMAR 10.09.60.08* A. The Program Fund shall include: (1) Interest and investment income attributable to the Program Fund; and (2) Money deposited to the account by a nonprofit health service plan in accordance with §C of this regulation. B. On or before April 1, 2003 and quarterly thereafter, the nonprofit health service plan required to subsidize the Program under Insurance Article, §14-106(d), Annotated Code of Maryland, shall deposit to the Program Fund the amount that is necessary to operate and administer the Program for the following quarter. C. The amount deposited by the nonprofit health service plan under §C of this regulation: (1) Shall be determined by the Department based on enrollment, expenditures, and revenue for the previous year; and (2) May not exceed the amounts specified in Insurance Article, §14-106(e), Annotated Code of Maryland. D. The Department shall provide funds to the Administrator, in accordance with the contract with the Administrator, for the cost of the State subsidy and administrative expenses incurred on behalf of the Program. E. The Administrator shall: (1) Permit inspection of its papers, books, and records pertaining to its operation of the Program by the Department or its designee; and (2) Cooperate with any inspections and audits performed on the Administrator or the Program by the Department or its designee. ### Chapter 61 — Medical Day Care Services Waiver **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-111, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.12 adopted as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); adopted permanently effective October 6, 2008 (35:20 Md. R. 1775) **Administrative History:** Regulation .01B amended effective February 15, 2016 (43:3 Md. R. 273); May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 485) **Administrative History:** Regulation .03B amended effective February 15, 2016 (43:3 Md. R. 273) **Administrative History:** Regulation .06B amended effective May 20, 2019 (46:10 Md. R. 485) #### Regulation .01 Definitions. *COMAR 10.09.61.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with the waiver, this chapter, and COMAR 10.09.30, assesses waiver applicants and participants. (2) “Authorized representative” means a spouse, legal guardian, parent, individual with power of attorney, or other individual designated in writing to the Department, authorized concerning the applicant's or recipient's eligibility under this chapter, to: (a) Act on an applicant's or recipient's behalf; and (b) Assist with the application or redetermination process and in other communication with the Department. (3) "Centers for Medicare and Medicaid Services (CMS)" means the federal agency responsible for administering Medicare, Medicaid, and several other health related programs. (4) “Department” means the Maryland Department of Health. (5) “Eligibility” means an individual's qualification for participation in the Medical Day Care Services Waiver, in accordance with the requirements of this chapter. (6) “Eligible” means that an individual is determined to meet the requirements of this chapter for eligibility as a Medical Day Care Services Waiver participant. (7) “Medicaid” means the Maryland Medical Assistance Program administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy recipients. (8) “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically handicapped adults, who, because of their degree of impairment, need health maintenance and restorative services supportive to their community living. (9) “Medical Day Care Services Waiver” means the program implemented under this chapter in accordance with the CMS-approved application for this waiver and any amendments to it submitted by the Department and approved by CMS. (10) “Multidisciplinary team” means the group consisting of members of the medical day care center’s professional staff, the participant, the participant’s authorized representative, healthcare professionals, and waiver case managers, as appropriate, that establishes and updates the participant’s service plan and plan of care. (11) “Nursing facility” means a facility that is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10. (12) “Participant” means an individual who: (a) Meets the qualifications for participation in the waiver as specified in Regulations .02 through .04 of this chapter; and (b) Is enrolled by the Department to receive waiver services. (13) “Plan of care” means a written plan established by the multidisciplinary team in accordance with COMAR 10.12.04.22 and based on: (a) A medical order; and (b) An assessment of the participant’s health status and special care requirements. (14) “Primary care provider” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant. (15) “Program” means the Maryland Medical Assistance Program. (16) “Provider” means a facility licensed under COMAR 10.12.04 furnishing medical day care services through an appropriate agreement with the Department, and identified as a Program provider by the issuance of an individual account number. (17) “Recipient” means a person who is certified by the Department as eligible for, and is receiving, Medical Assistance benefits. (18) “Service plan” means an approved document which specifies the type, amount, frequency, and duration of all waiver and other Medicaid services required to safely support the waiver participant in the community. (19) “State Plan” means a comprehensive, written commitment by a State Medicaid agency, submitted under §1902(a) of the Social Security Act, to administer or supervise the administration of the Medical Assistance Program in accordance with federal requirements. (20) “Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. (21) “Waiver” means the Medical Day Care Services Waiver as implemented through this chapter. (22) “Waiver applicant” means an individual who is applying for participation in the waiver to receive the services covered under this chapter. (23) “Waiver year” means the State fiscal year from July 1 through June 30. #### Regulation .02 Medical Assistance Eligibility. *COMAR 10.09.61.02* A. Categorically Needy. An individual is eligible for waiver services as categorically needy if the individual is receiving Medical Assistance as a: (1) Recipient of Supplemental Security Income (SSI); (2) Member of a low income family with children, as described in §1931 of the Social Security Act; or (3) Recipient eligible in another mandatory or optional categorically needy coverage group covered in the community under the State Plan. B. Medically Needy. An individual is eligible for waiver services as medically needy if the individual is receiving Medical Assistance as an aged, blind, or disabled medically needy individual in accordance with COMAR 10.09.24.03D and .09. C. An individual is not eligible to receive waiver services if a disposal of assets or establishment of a trust or annuity results in a penalty under COMAR 10.09.24, until such time as the penalty period expires. #### Regulation .03 Participant Eligibility. *COMAR 10.09.61.03* A. Medical Eligibility. (1) To be eligible for the services covered under COMAR 10.09.07, a waiver applicant or participant shall be certified by the Department or its designee as needing nursing facility services, pursuant to COMAR 10.09.10. (2) The initial assessment for enrollment to the Program shall be conducted by AERS and submitted to the Department or its designee for certification. (3) For the purpose of enrollment, the assessment of the applicant’s need for nursing facility services is valid for 1 year. (4) The Department or its designee shall annually certify as medically eligible only those financially eligible participants who require nursing facility services as defined under COMAR 10.09.10. (5) The annual continued stay assessment shall be conducted by the medical day care provider's nursing staff or, at the discretion of the Department, by the Department's designee, with an assessment instrument approved by the Department and submitted to the Department or its designee for certification. B. Technical Eligibility. An individual shall be determined by the Department or its designee to be eligible for waiver services if the individual: (1) Is 16 years old or older; (2) Is not enrolled simultaneously in both the Medical Day Care Services Waiver, and: (a) Another Medicaid home and community-based services waiver under §1915(c) of the Social Security Act; (b) Programs of All-Inclusive Care for the Elderly (PACE); or (c) A Medicaid capitated program that includes nursing facility or community-based long term care services; (3) Has a service plan that: (a) Recommends medical day care services at least one time per week based on a medical order; (b) Is based on an initial or continued stay assessment approved by the Department or its designee; (c) Is developed and signed by: (i) The participant or authorized representative; and (ii) Appropriate members of the multidisciplinary team; (d) Is revised as necessary due to a significant change in the participant’s condition or service needs; (e) Is reviewed at least annually by the participant or authorized representative and the multidisciplinary team to: (i) Determine the appropriateness and adequacy of the services; and (ii) Ensure that the services furnished are consistent with the nature and severity of the participant's condition and with the plan of care; (4) Is determined by the Department or its designee as appropriate for home and community-based care; (5) Is informed of feasible alternatives to nursing facility services that are available under the waiver; (6) Is offered the choice between waiver and nursing facility services; and (7) Chooses, or the individual's authorized representative chooses on the individual's behalf, to receive waiver services. #### Regulation .04 Waiver Eligibility. *COMAR 10.09.61.04* A. Based on the criteria established in Regulations .02 and .03 of this chapter, an applicant's eligibility for services under this chapter shall be established by the Department, and waiver eligibility may not begin before the latest of the following five dates: (1) Waiver application date; (2) Effective date of medical certification for the waiver's institutional level of care; (3) Date that the applicant's written waiver service plan is established; (4) Date that the applicant or representative signed a form designated by the Department to indicate the choice of waiver services as an alternative to institutionalization; or (5) Date of the applicant's discharge from institutionalization in a long term care facility, if applicable. B. The Department or its designee shall reevaluate a participant's eligibility for waiver services annually. C. A participant shall be terminated from participation in the waiver as of the effective date of ineligibility as determined by the Department if the participant: (1) No longer meets the eligibility requirements specified in Regulations .02 and .03 of this chapter; (2) Voluntarily chooses, or the participant's authorized representative chooses on the participant's behalf, to disenroll from the waiver; (3) Moves to another state; (4) Is an inpatient for 30 consecutive days or more in a chronic hospital or nursing facility; (5) Does not receive waiver services for 90 consecutive days; or (6) Dies. D. Reenrollment in the Waiver. If an individual is terminated from the waiver, the same individual may reenroll in the waiver during the same waiver year, if the individual meets all of the eligibility requirements of the waiver. #### Regulation .05 Annual Cap and Registry for Waiver Participation. *COMAR 10.09.61.05* A. For each State fiscal year beginning on July 1, the Department shall establish a cap, approved by CMS, for the number of unduplicated individuals who may receive the services covered under this chapter, based on available State and federal funding. B. The annual cap for waiver participation may be revised, based on the Department's updated estimates of participants' Program expenditures for the State fiscal year, as compared with the available funding. C. Eligible individuals shall be enrolled in the waiver program on a first-come, first-served basis until the annual cap on waiver participation is reached. D. Once the annual cap on waiver participation is reached: (1) A registry shall be established for individuals interested in applying for waiver services; and (2) Individuals on the registry shall have an opportunity to apply for the waiver as openings become available. #### Regulation .06 Conditions for Provider Participation. *COMAR 10.09.61.06* A. Conditions for provider participation are those set forth in COMAR 10.09.07. B. Providers shall maintain a service plan for each participant that includes: (1) Name, address, and telephone number of the participant; (2) Medical Assistance number of the participant; (3) Name and telephone number of the participant’s primary care provider and of any managed care organization with which the participant is enrolled; (4) Dated signatures of the participant or authorized representative, and each of the other individuals participating on the multidisciplinary team; (5) A statement that the participant or authorized representative shall have access to the individual's medical day care services plan of care; (6) A statement that enrollment is voluntary, but that the participant or the participant's caregiver shall notify the medical day care center when the participant is unable to attend; (7) Authorization and frequency of attendance of medical day care services; (8) Names of provider or providers that render waiver or State Plan services; and (9) Approval by the Department or its designee. #### Regulation .07 Covered Services. *COMAR 10.09.61.07* Covered services are those set forth in COMAR 10.09.07. #### Regulation .08 Limitations. *COMAR 10.09.61.08* Limitations are those set forth in COMAR 10.09.07. #### Regulation .09 Payment Procedures. *COMAR 10.09.61.09* Payment procedures are those set forth in COMAR 10.09.07. #### Regulation .10 Appeal Procedures for Applicants and Participants. *COMAR 10.09.61.10* Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04. #### Regulation .11 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.61.11* A. Cause for suspension or removal and imposition of sanctions for providers shall be in accordance with COMAR 10.09.36. B. If the Department determines that a provider has failed to accurately assess the rehabilitative, cognitive, behavioral, and functional abilities and deficits, or medical service needs of an applicant or consumer, and to accurately convey such an assessment to the Department for purposes of obtaining an authorization to provide medical day care services, the Department shall: (1) Suspend all eligibility decisions based upon assessments submitted by the provider until such time as the provider's assessment is validated by an independent assessment conducted by the Department's utilization control agent or the Department's designee; and (2) Conduct remedial training of provider staff in accurately assessing rehabilitative, cognitive, behavioral, and functional abilities and deficits, or medical service needs, and in accurately conveying such assessments to the Department or its designee for purposes of establishing medical eligibility for medical day care service. #### Regulation .12 Interpretive Regulation. *COMAR 10.09.61.12* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 62 — Separate Children’s Health Insurance Program (CHIP) and CHIP Health Services Initiative Eligibility **Authority:** Estates and Trusts Article, §14.5-1002; Health-General Article, §§2-104(b), 2-105(b), 15-103, 15-105, 15-121, and 15-401—15-407; Annotated Code of Maryland **Administrative History:** Effective date: November 13, 2023 (50:22 Md. R. 974) #### Regulation .01 Purpose and Scope. *COMAR 10.09.62.01* A. This chapter governs the determination of eligibility for the separate Children’s Health Insurance Program (separate CHIP) and the CHIP Health Services Initiative with an income standard based on the modified adjusted gross income methodology specified in the Affordable Care Act of 2010, effective January 1, 2014. B. Eligibility for the separate CHIP Program may be established for a targeted low-income child from conception to birth when the birthing parent would qualify for Medicaid but for their immigration status, when the family income is equal to or less than 250 percent of the federal poverty level. C. Eligibility for the CHIP Health Services Initiative for the birthing parent of a targeted low-income child may be established beginning on the first day of the month following the end of the pregnancy and ending on the last day of the fourth month after the pregnancy ends if the targeted low-income child applied for the separate CHIP Program on or before the day prior to their birth and was subsequently found eligible for the separate CHIP Program. #### Regulation .02 Definitions. *COMAR 10.09.62.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Affordable Care Act” means the Patient Protection and Affordable Care Act of 2010 (Pub.L.111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub.L.111-152), as amended by the Three Percent Withholding Repeal and Job Creation Act (Pub.L.112-56). (2) Applicant. (a) “Applicant” means an individual whose written application for the separate CHIP Program has been submitted to the local health department or the local department of social services but has not received final action. (b) “Applicant” includes an individual whose application is submitted through a representative. (3) “Application” means the filing of a written, telephonic, or electronic signed application for health coverage in an insurance affordability program to the Department or its designee. (4) “Application date” means the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. (5) “Authorized representative” has the meaning stated in COMAR 10.01.04.12. (6) “Birthing parent” means the individual who gives birth to the targeted low-income child who is enrolled in the separate CHIP Program on the day prior to their birth. (7) “CHIP Health Services Initiative” means services offered to improve the health of low-income children pursuant to §2105(a)(1)(D)(ii) of the Social Security Act. (8) “Department” means the Maryland Department of Health. (9) “Determination” means a decision regarding an applicant’s eligibility for the separate CHIP Program. (10) “Eligibility worker” means an employee of the local health department, or the local department of social services, responsible for determining the eligibility of applicants and participants. (11) “Family members” means those individuals living with the applicant whose income is counted as household income under Regulation .07B of this chapter. (12) “Federal poverty level” means the nonfarm income official poverty level as defined by the Office of Management and Budget and revised annually in accordance with §673(2) of the Omnibus Budget Reconciliation Act of 1981. (13) “Inpatient services” means services received by a participant while in a medical institution, birthing center, or clinic for which Medical Assistance is provided. (14) “Institution for mental diseases” means an institution which falls within the jurisdiction of Health-General Article, §19-307(a)(1), Annotated Code of Maryland, and is licensed under COMAR 10.07.04. (15) “Insurance affordability program” means a program that is one of the following: (a) Maryland Medicaid; (b) The Maryland Children’s Health Insurance Program (CHIP), including the program known as Maryland Children’s Health Program (MCHP) Premium; (c) The separate CHIP Program; (d) An optional state basic health program established under §1331 of the Affordable Care Act; (e) A program that makes available to qualified individuals coverage in a qualified health plan through the Maryland Health Benefit Exchange with advance payments of the premium tax credit established under 26 U.S.C. §36B of the Internal Revenue Code; or (f) A program that makes available coverage in a qualified health plan through the Maryland Health Benefit Exchange with cost-sharing reductions established under 42 U.S.C. §1402 of the Affordable Care Act. (16) “Living together” means sharing a common household. (17) “MAGI” means modified adjusted gross income, as calculated for purposes of determining eligibility for insurance affordability programs under the Affordable Care Act. (18) “Maryland Health Benefit Exchange” means the unit of State government that determines initial and continuing eligibility for the MAGI-based insurance affordability programs, including, by delegation, certain eligibility in the program. (19) “Maryland Medicaid Managed Care Program” has the meaning stated in COMAR 10.09.24.02. (20) “Period under consideration” has the meaning stated in COMAR 10.09.24.02. (21) “Postpartum period” means the period of time beginning on the first day of the month following the end of the pregnancy and ending on the last day of the fourth month after the pregnancy ends. (22) “Public institution” has the meaning stated in COMAR 10.09.24.02. (23) “Qualified alien” has the meaning defined in 8 U.S.C. §1641. (24) “Participant” means an individual who is certified as eligible for the Maryland Children’s Health Program. (25) “Redetermination” has the meaning stated in COMAR 10.09.24.02. (26) “Separate CHIP Program” means the program for targeted low-income children established under Title XXI of the Social Security Act. (27) “Spouse” has the meaning stated in COMAR 10.09.24.02. (28) “Targeted low-income child” means an individual who qualifies for the Maryland Children’s Health Program from conception to birth when the birthing parent is not eligible for Medicaid as a citizen or qualified alien, when the family income is equal to or less than 250 percent of the federal poverty level. (29) “Title XIX” means the title of the Social Security Act, 42 U.S.C. §1396 et seq., which governs establishment of a medical assistance program for low-income individuals. (30) “Title XXI” means the title of the Social Security Act through which funding is provided, in part, for the separate CHIP Program. #### Regulation .03 Coverage Groups. *COMAR 10.09.62.03* A. Eligibility for the separate CHIP Program may be established for a targeted low-income child from conception to birth when the: (1) Birthing parent is not a citizen or qualified alien; and (2) Family income is equal to or less than 250 percent of the federal poverty level. B. Eligibility for the CHIP Health Services Initiative may be established for a birthing parent for postpartum coverage if a targeted low-income child applied for the separate CHIP Program on or before the day prior to their birth and was subsequently found eligible for the separate CHIP Program. #### Regulation .04 Application. *COMAR 10.09.62.04* A. The Department or its designee shall determine eligibility for a targeted low-income child and a birthing parent. B. The Department or its designee shall give oral, written, or electronic information about the separate CHIP Program and CHIP Health Services Initiative such as: (1) Requirements for eligibility; (2) Available services; (3) An individual’s rights and responsibilities; (4) Information in plain English, supported by translation services; and (5) Information accessible to disabled individuals requesting an application. C. An individual requesting health coverage from an insurance affordability program shall be given an opportunity to apply. D. The Department or its designee shall make the application available to the individual without delay by telephone, by mail, in person, or by internet or other available electronic means, and in a manner accessible to disabled individuals requesting an application. E. A resident temporarily absent from the State but intending to return may apply for health coverage from an insurance affordability program by telephone, by mail, in person, or by internet or other available electronic means to the Department or its designee in any jurisdiction. The individual shall: (1) Demonstrate continued residency in the State; and (2) Meet all nonfinancial and financial requirements to be determined eligible. F. Application Filing and Signature Requirements. (1) An individual who wishes to apply for health coverage under an insurance affordability program shall submit a written, telephonic, or electronic application signed under penalty of perjury to the Department or its designee in any jurisdiction. An applicant is responsible for completing the application but may be assisted in the completion by an individual of the applicant’s choice. (2) For the purpose of establishing eligibility of a child applicant who is neither pregnant nor postpartum, a parent or stepparent living with the child shall complete and sign the written, telephonic, or electronic application. If the child does not live with a parent, an authorized representative who is 21 years old or older shall complete and sign the application. G. The date of application shall be the date on which a written, telephonic, or electronic signed application is received by the Department or its designee. The application may be mailed or submitted electronically to the Department or its designee. H. An individual who has filed a written, telephonic, or electronic application may voluntarily withdraw that application, but the application remains the property of the Department or its designee and the withdrawal does not affect the periods under consideration specified under §I of this regulation. I. Period Under Consideration. (1) The Department or its designee shall establish a current period under consideration based on the date of application established under §G of this regulation. (2) For a targeted low-income child, the period under consideration is from conception to birth, and for retroactive eligibility, the 1, 2, or 3 months immediately preceding the month of application for the separate CHIP Program if those months are prior to the birth. (3) For the birthing parent, the period under consideration is the postpartum period and contingent on the application of the targeted low-income child on or before the last day of the fourth month after the pregnancy ends. J. Processing applications time limitations shall operate in accordance with the requirements of COMAR 10.09.24.04. K. Required Information. All information needed to determine eligibility for the separate CHIP Program and CHIP Health Services Initiative shall be reported. When there is evidence of inconsistency between information attested by the applicant and data reported by the State and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. #### Regulation .05 Application — Additional Requirements. *COMAR 10.09.62.05* A. Third-Party Liability. (1) A participant shall notify the Department or its designee within 10 working days when medical treatment has been provided as a result of a motor vehicle accident or other occurrence in which a third party might be liable for the participant’s medical expenses. (2) A participant shall cooperate with the Department or its designee in completing a form designated by the Department to report all pertinent information and in collecting available health insurance benefits and other third-party payments. (3) In accident situations, a participant shall notify the Department or its designee of the: (a) Time, date, and location of the accident; (b) Name and address of the participant’s attorney; (c) Names and addresses of all parties and witnesses to the accident; and (d) Police report number if an investigation is made. B. The Department or its designee shall: (1) Maintain a written or electronic record including documentation of any required elements of eligibility; and (2) Restrict disclosure of information concerning a participant to purposes directly connected with the administration of the Medical Assistance Program, including: (a) Establishing eligibility; (b) Determining the extent of coverage under Medical Assistance; (c) Providing services for participants; and (d) Conducting or assisting an investigation, prosecution, or civil or criminal proceeding related to the administration of the Medical Assistance Program. C. An applicant or participant shall give consent to verify information needed to establish eligibility to the Department or its designee, by submitting a written, telephonic, or electronic application. #### Regulation .06 Nonfinancial Eligibility Requirements. *COMAR 10.09.62.06* A. Individuals qualifying for coverage under this section are not required to provide a Social Security number or meet satisfactory immigration status. B. Residency. To be eligible for benefits under this chapter, an individual shall be a resident of Maryland, in accordance with the requirements of COMAR 10.09.24.05-3. C. Age. To be eligible for benefits under this chapter, a birthing parent shall apply for coverage before the last day of the fourth month after the pregnancy ends, regardless of the birthing parent’s age. D. Inmate of a Public Institution. To receive benefits under this chapter, a targeted low-income child or birthing parent may not be an inmate of a public institution, as specified in COMAR 10.09.24.05-5B. E. Institution for Mental Diseases. To be eligible for benefits under this chapter, a targeted low-income child or birthing parent may not be a patient in an institution for mental diseases, unless such individuals are eligible in accordance with COMAR 10.09.24.05-5C. F. No Private Health Insurance. In order to be eligible for benefits under Title XXI of the Social Security Act, a targeted low-income child or birthing parent whose income is equal to 133 percent but less than 250 percent of the Federal Poverty Level may not be covered by an employer-sponsored health benefit plan. G. Required Information. (1) An applicant shall report to the Department all information needed to determine eligibility for the separate CHIP Program and CHIP Health Services Initiative. (2) When there is evidence of inconsistency between information attested by the applicant and data reported by the State and federal databases, the applicant shall be required to offer an explanation and appropriate verification to reconcile the inconsistency. #### Regulation .07 Consideration of Household Income. *COMAR 10.09.62.07* A. The applicant shall report the income of any family member, except for the income of a member that does not file a federal tax return and is not claimed as a federal tax dependent. B. Determining Countable Household Income. (1) In determining an applicant’s financial eligibility for the separate CHIP Program, the applicant’s current household income is considered. (2) For the targeted low-income child applicant, household income shall consist of the income of the child applicant and the following family members when living with the child applicant: (a) The child applicant’s parents; and (b) At the option of the child applicant’s parents, any of the child applicant’s siblings. C. When an individual has regular income the amount to be considered is that which is available or can reasonably be expected to be available for a projected period of 12 months, including the month of application. D. Treatment of Income. (1) Countable gross income for the separate CHIP Program shall be the household income calculated according to MAGI. (2) MAGI income limits shall be: (a) Converted from traditional income limits to account for elimination of income disregards; and (b) Increased by 5 percentage points of the federal poverty level for the following circumstances: (i) When an individual’s income exceeds the Medicaid income standard; and (ii) The income standard is the highest income standard under which the individual can be determined eligible. (3) Household Composition. For purposes of determining the income standard applicable to an applicant or participant, the following rules apply: (a) An individual plus anyone for whom the individual claims personal exemption shall be included in the federal tax filing unit in the taxable year in which an initial determination or renewal of eligibility is being made; (b) For an individual who does not file a federal tax return and is not claimed as a federal tax dependent in the taxable year in which an initial determination or renewal of eligibility is being made, the household size shall consist of the individual and the following individuals: (i) Spouse; and (ii) Natural, adopted, or step children; (c) In the taxable year in which an initial determination or renewal of eligibility is being made, the household size of a child applicant shall consist of the child and the following individuals: (i) Natural, adopted, or step parents; and (ii) Natural, adopted, or step siblings; (d) In the case of a married couple living together, each spouse shall be included in the household of the other spouse, regardless of whether they expect to file a joint federal tax return in the taxable year in which an initial determination or renewal of eligibility is being made; and (e) For a child applicant, the household size shall consist of the child and the following individuals: (i) Natural, adopted, or step parents; and (ii) Natural, adopted, or step siblings. (4) No resources or assets test may be applied to an applicant or participant who is subject to a MAGI-based income test. #### Regulation .08 Determining Financial Eligibility. *COMAR 10.09.62.08* An applicant is financially eligible for the separate CHIP Program or the CHIP Health Services Initiative if, for the period under consideration, the applicant’s countable household income as determined under Regulation .07 of this chapter does not exceed 250 percent of the federal poverty level for a family size equal to the size of the family of the applicant. #### Regulation .09 Certification Periods. *COMAR 10.09.62.09* A. For a targeted low-income child, certification for the separate CHIP Program begins: (1) On the first day of the month of application, no earlier than conception, and continues until the last day of the month in which the pregnancy ends; or (2) For retroactive coverage, if medical expenses were incurred during the earlier months: (a) 3 months before the month of application but no earlier than conception; and (b) Continues until the last day of the month in which the pregnancy ends. B. For the birthing parent of a targeted low-income child, certification for the CHIP Health Services Initiative begins: (1) On the first day of the month following the end of the pregnancy, and continues until the last day of the fourth month after the pregnancy ends; (2) For retroactive coverage, if medical expenses were incurred during the earlier months: (a) 3 months before the month of application, if those months are not prior to the last day of the month in which the pregnancy ends; and (b) Continues until the last day of the month in which the pregnancy ends. #### Regulation .10 Covered Services. *COMAR 10.09.62.10* A. A targeted low-income child certified for the separate CHIP Program is entitled to all health benefits through the Maryland Medicaid Managed Care Program. B. A birthing parent certified for the CHIP Health Services Initiative is entitled to all health benefits through the Maryland Medicaid Managed Care Program. #### Regulation .11 Post-Eligibility Requirements. *COMAR 10.09.62.11* A. Notice of Eligibility Determination. The Department or its designee shall inform an applicant of the applicant’s legal rights and obligations and give the applicant written or electronic notification of the following: (1) For eligible individuals: (a) The basis and effective date for eligibility; (b) Instructions for reporting changes that may affect the participants’ eligibility; and (c) The right to request a hearing; or (2) For ineligible individuals: (a) A finding of ineligibility, the reason for the finding, and the regulation supporting the finding; (b) Information regarding application for MAGI Exempt coverage groups; and (c) The right to request a hearing. B. Participant Responsibility. (1) After an individual has been determined to be eligible for the separate CHIP Program and is enrolled in the separate CHIP Program, the participant or the participant’s representative shall: (a) Within 10 days of the occurrence, notify the Department if there is a change in the participant’s, the participant’s parent’s, or the participant’s guardian’s: (i) Income; (ii) Employment; (iii) Address; or (iv) Health insurance coverage status; (b) Limit use of the Medical Assistance card to the individual whose name appears on the card; and (c) When written or electronic notice of cancellation is received, discontinue use of the Medical Assistance card on the first day of ineligibility and return the card to the Department. (2) Failure to comply with §B(1) of this regulation may result in: (a) The termination of assistance; or (b) Referral to the Department for fraud investigation, or for criminal or civil prosecution. (3) A participant shall cooperate with the Department’s quality control and audit review process, including verification of all information pertinent to the determination of eligibility. (4) If the participant refuses to cooperate, the participant’s coverage shall be terminated subject to timely and adequate notice under COMAR 10.01.04.03. C. Unscheduled Redetermination. (1) The Department or its designee shall: (a) Promptly make an unscheduled redetermination of a child participant’s eligibility when changes in circumstances or relevant facts are: (i) Reported by someone on the participant’s behalf; or (ii) Brought to the attention of the Department or its designee from other responsible sources; (b) Notify the participant that redetermination is required to establish continuing eligibility; and (c) Notify the participant of the required information and verifications needed to determine eligibility and the time standards in acting in the redetermination process. (2) Eligibility Decisions. Participants who are determined: (a) Eligible for the remainder of the certification period shall be sent notice in accordance with §A(1) of this regulation; or (b) Ineligible because of a change in circumstances or failure to establish eligibility following a change in circumstance shall be sent notice in accordance with §A(2) of this regulation. (3) A participant whose eligibility has been canceled may reapply at any time after the cancellation of eligibility and a new period under consideration shall be established. D. Scheduled Redetermination. Except for children eligible as newborns of eligible individuals the Department or its designee shall make a scheduled redetermination of a child participant’s eligibility at least every 12 months. #### Regulation .12 Hearings. *COMAR 10.09.62.12* The requirements relating to hearings under COMAR 10.01.04 apply to this chapter. #### Regulation .13 Fraud and Abuse. *COMAR 10.09.62.13* The requirements relating to fraud and abuse under COMAR 10.09.24.14 apply to this chapter. #### Regulation .14 Adjustments and Recoveries. *COMAR 10.09.62.14* The requirements relating to adjustments and recoveries under COMAR 10.09.24.15, except for COMAR 10.09.24.15A(1) and (2), apply to this chapter. #### Regulation .15 Interpretive Regulation. *COMAR 10.09.62.15* State regulations shall be interpreted in conformity with applicable federal statutes and regulations, except if the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation. ### Chapter 63 — Community Violence Prevention Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: November 13, 2023 (50:22 Md. R. 974) #### Regulation .01 Definitions. *COMAR 10.09.63.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Certified violence prevention professional” means a prevention professional who meets the requirements of Regulation .02 of this chapter. (2) “Community violence” means intentional acts of interpersonal violence committed in public areas by individuals who are not family members or intimate partners of the victim. (3) “Community violence prevention services” means evidence-based, trauma-informed, supportive, and nonpsychotherapeutic services provided by a certified violence prevention professional, within or outside a clinical setting, for the purpose of promoting improved health outcomes and positive behavioral change, preventing injury recidivism, and reducing the likelihood that an individual who is the victim of community violence will commit or promote violence. (4) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq. (5) “Interpersonal violence” means the intentional use of physical force or power against another individual by an individual or a small group of individuals. (6) “Provider” means the entity who through appropriate agreement with the Department has been identified as a Program provider by the issuance of an individual account number. #### Regulation .02 Certification Requirements. *COMAR 10.09.63.02* A. An individual rendering services under this chapter shall complete an accredited training and certification program for certified violence prevention professionals, approved by the Department. B. An accredited training and certification program for certified violence prevention professionals shall: (1) Consist of at least 35 hours of initial training, addressing the following topics: (a) The profound effects of trauma and violence and the basics of trauma-informed care; (b) Community violence prevention strategies, including conflict mediation and retaliation prevention related to community violence; (c) Case management and advocacy practices; and (d) Patient privacy and the federal Health Insurance Portability and Accountability Act of 1996; and (2) Require at least 6 hours of continuing education every 2 years. #### Regulation .03 Conditions for Participation. *COMAR 10.09.63.03* A. General requirements for participation in the Program are that a provider shall: (1) Meet all conditions for participation as set forth in COMAR 10.09.36.03; and (2) If rendering services via telehealth, comply with COMAR 10.09.49 and any sub regulatory guidance issued by the Department. B. Specific requirements for participation in the Program as a community violence prevention service provider are that a provider shall: (1) Maintain documentation that an individual rendering community violence prevention services under this chapter meets the certification requirements as provided in Regulation .02 of this chapter and maintain documentation of certification; (2) Maintain an affiliation with at least one trauma Primary Adult Resource Center (PARC), level I, or level II licensed short-term general hospital or children’s hospital in Maryland through which the provider entity is authorized to provide community violence prevention services to beneficiaries in the hospital; and (3) Ensure that the certified violence prevention professional is providing community violence prevention services in compliance with any applicable standard of care, rule, regulation, and State or federal law. #### Regulation .04 Covered Services. *COMAR 10.09.63.04* A. Effective July 1, 2023, the Department shall reimburse for community violence prevention services as described in §B of this regulation when these services: (1) Are medically necessary; and (2) Rendered to a participant who: (a) Has been exposed to community violence or has a personal history of injury resulting from community violence; (b) Is at an elevated risk of violent injury or retaliation resulting from another act of community violence, as determined by a certified or licensed health care provider or social services provider; and (c) Has been referred by a certified or licensed health care provider to a certified violence prevention professional to receive community violence prevention services. B. Community violence prevention services shall include one or more of the following interventions: (1) Mentorship; (2) Conflict mediation; (3) Crisis intervention; (4) Referrals to certified or licensed health care professionals or social services providers; (5) Patient education; and (6) Screening services. C. The Program shall cover a maximum of 100 30-minute units of services in a rolling 12-month period. #### Regulation .05 Limitations. *COMAR 10.09.63.05* Under this chapter, the Program does not cover services: A. Following an episode of intimate partner violence or domestic violence; B. Delivered by a provider that is not affiliated with a trauma PARC, level I, or level II licensed short-term general hospital or children’s hospital in Maryland; and C. Provided in excess of 100 30-minute units of services in a rolling 12-month period. #### Regulation .06 Payment Procedures. *COMAR 10.09.63.06* A. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. B. The provider shall charge the Program the provider’s customary charge to the general public for similar services. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §G of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. C. The Program will reimburse a provider for covered services: (1) The lesser of the provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) In accordance with §G of this regulation. D. The provider may not bill the Program or the participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; or (4) Providing a copy of a program participant’s medical record when requested by another provider on behalf of the participant. E. Payments for services rendered to a Program participant shall be made directly to a qualified provider or program. F. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. G. Reimbursement. (1) Payments shall be made in 30-minute units of service. (2) Effective July 1, 2023, rates for the services outlined in this chapter shall be reimbursed at $32.76 per unit. ### Chapter 64 — Collaborative Care Model **Authority:** Health-General Article, §15–141.1, Annotated Code of Maryland **Administrative History:** Effective date: August 5, 2024 (51:15 Md. R. 707) #### Regulation .01 Definitions. *COMAR 10.09.64.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Behavioral health care manager” means a nurse, clinical social worker, or psychologist working under the oversight and direction of the physician or other primary care provider with formal education or specialized training to provide coordination and intervention in behavioral health. (2) “Collaborative Care Model” means the Psychiatric Collaborative Care Model, a patient-centered, evidence-based approach for integrating physical and behavioral health services in primary care settings that includes: (a) Care coordination and management; (b) Regular, systematic monitoring and treatment using a validated clinical rating scale; (c) Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and (d) Regular, systematic consultation for patients who do not show clinical improvement. (3) “Federally qualified health center (FQHC)" means an entity as defined by Health-General Article, §24-1301, Annotated Code of Maryland, and §1905(l)(2)(B) of the Social Security Act. (4) “Participant” means an individual who: (a) Has been determined to meet the qualifications for services under the Collaborative Care Model as specified in Regulation .04 of this chapter; and (b) Is enrolled with the Department to receive Medicaid services. (5) “Primary care provider (PCP)” means a physician, or other provider type as defined in COMAR 10.67.05.05, who is the primary coordinator of care for the enrollee, and whose responsibility is to provide accessible, continuous, comprehensive, and coordinated health services covering the full range of benefits required by the Maryland Medical Assistance Program. (6) “Program” means the Maryland Medical Assistance Program. (7) “Psychiatric consultant” means a licensed psychiatrist, psychiatric nurse practitioner, addiction medicine specialist, or any other behavioral health medicine specialist as allowed under federal regulations governing the model who is trained in psychiatry and qualified to prescribe medication. #### Regulation .02 Conditions for Participation. *COMAR 10.09.64.02* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. A provider may not knowingly employ or contract with a person, partnership, or corporation which the Program has disqualified from providing or supplying services to Program participants. #### Regulation .03 Covered Services. *COMAR 10.09.64.03* The Program covers the following medically necessary services rendered to participants under the Collaborative Care Model: A. Care coordination and management; B. Regular, systematic monitoring and treatment using a validated clinical rating scale; C. Regular, systematic psychiatric or substance use disorder caseload reviews, or both; and D. Regular, systematic consultation for patients who do not show clinical improvement. #### Regulation .04 Eligibility for Services. *COMAR 10.09.64.04* Eligibility for services under the Collaborative Care Model is limited to participants with a behavioral health diagnosis that is clinically appropriate for the primary care setting for which there is a validated tool to monitor symptoms and quantify outcomes. #### Regulation .05 Limitations. *COMAR 10.09.64.05* Under this chapter, the Program does not cover the following: A. Services not specified in Regulation .03 of this chapter; B. Services not medically necessary; C. Services prohibited by the Maryland Nurse Practice Act or by the State Board of Nursing; D. Advanced practice nursing services included as part of the cost of: (1) An inpatient facility; (2) A hospital outpatient department; or (3) A freestanding clinic; E. Visits by or to the provider solely for the purpose of the following: (1) Prescription, drug, or food supplement pick-up; (2) Recording of an electrocardiogram; (3) Ascertaining the patient’s weight; (4) Interpretation of laboratory tests or panels; or (5) Prescribing or administering medication; F. Drugs and supplies which are acquired by the provider at no cost; G. Services paid under the free-standing dialysis program as described in COMAR 10.09.22; H. Prescriptions and injections for central nervous system stimulants and anorectic agents when used for weight control; I. Acupuncture; J. Hypnosis; K. Travel expenses; L. Investigational or experimental drugs and procedures; M. Services denied by Medicare as not medically justified; N. Specimen collection, except by venipuncture and capillary or arterial puncture, as a separate service; O. Laboratory or X-ray services performed by another facility, which shall be billed to the Program directly by the facility; and P. For certified nurse midwives, a separate visit charge on date of delivery. #### Regulation .06 Payment Procedures. *COMAR 10.09.64.06* A. The provider shall submit the request for payment of services rendered according to procedures established by the Program and in the form designated by the Program. B. The Program reserves the right to return to the provider, before payment, all claims not properly signed, completed, and accompanied by properly completed forms required by the Program. C. Unless the service is free to the general public, the provider shall charge the Program the provider’s customary charge to the general public for similar services. D. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §G of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. E. The Program will pay for covered services, the lesser of: (1) The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The Program’s fee schedule. F. The provider may not bill the Program or the participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; (4) Professional services rendered via telehealth when services are indicated as an exclusion; or (5) Providing a copy of a participant’s medical record when requested by another provider on behalf of the participant. G. Reimbursement. (1) Providers may bill one 60-minute or 70-minute code per month, and two additional 30-minute codes per month, unless otherwise excepted in §G(2)or (3) of this regulation. (2) FQHCs may bill once per month, using a separate FQHC code. (3) If the primary care team determines that the participant’s condition requires more or less frequent visits than described above, the care manager may order an alternate schedule. (4) The Maryland Medical Assistance Program's procedures for payment are contained in COMAR 10.09.02.07D. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.64.07* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .08 Causes for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.64.08* Causes for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.64.09* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. ### Chapter 65 — Maryland Medicaid Managed Care Program: Managed Care Organizations *Transferred to COMAR 10.67.04* **Administrative History:** Effective date: **Administrative History:** Regulations .01—.23 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) **Administrative History:** Regulations .01—.23 adopted effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulations .02C, .04C, .08, .11, .15, .17A, .18, .20B, and .22C amended and Regulation .11-1 adopted as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 **Administrative History:** Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144); November 1, 1999 (26:22 Md. R. 1692); February 18, 2002 (29:3 Md. R.220) **Administrative History:** Regulation .02 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .02G amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .02G and H amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .03P amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .03T adopted effective February 18, 2002 (29:3 Md. R.220) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .04C amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .05 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .05 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .05K amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .08 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .10B amended effective February 18, 2002 (29:3 Md. R.220) **Administrative History:** Regulation .11 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .11 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .11 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. 1838) **Administrative History:** Regulation .11 amended effective February 18, 2002 (29:3 Md. R.220); December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .11-1 and .11-2 adopted February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .11-1 and .11-2E amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulations .11-1 and .11-2 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1838) **Administrative History:** Regulation .15 amended effective February 9, 1998 (25:3 Md. R. 144); December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R.220) **Administrative History:** Regulation .15B amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .15D, E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .16 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .17A amended effective February 9, 1998 (25:3 Md. R. 144); December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .17B amended effective February 18, 2002 (29:3 Md. R.220) **Administrative History:** Regulation .18 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .18-1 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993) **Administrative History:** Regulation .18-1 amended effective December 25, 2000 (27:25 Md. R.2281) **Administrative History:** Regulation .18-1C adopted effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Regulation .19 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); emergency status extended at 26:1 Md. R. 17, 26:6 Md. R. 480, and 26:8 Md. R. 614; emergency status expired May 1, 1999 **Administrative History:** Regulation .19 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999 **Administrative History:** Regulation .19 amended effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Regulation .19 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 **Administrative History:** Regulation .19 amended effective December 25, 2000 (27:25 Md. R.2281) **Administrative History:** Regulation .19 amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .19A amended as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931 and 29:4 Md. R. 413 **Administrative History:** Regulation .19B amended effective December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .19B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .19D amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulations .19-1—.19-3 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 **Administrative History:** Regulations .19-1—.19-4 adopted effective December 25, 2000 (27:25 Md. R. 2281) **Administrative History:** Regulations .19-1 and .19-2 repealed and new Regulation .19-1 adopted effective December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .19-1 repealed as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); repealed permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulations .19-3 and .19-4 amended and recodified to be new Regulations .19-2 and .19-3 effective December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .19-3 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .19-3 amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .19-4 adopted effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulations .19-5 and.19-6 adopted as an emergency provision effective March 31, 2001 (28:7 Md. R. 685); emergency status extended at 28:22 Md. R. 1931; emergency status extended at 29:4 Md. R. 413 **Administrative History:** Regulation .20 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .20 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .20A amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .21 amended effective December 25, 2000 (27:25 Md. R. 2281); December 24, 2001 (28:25 Md. R. 2190); July 7, 2003 (30:13 Md. R. 854) **Administrative History:** Regulation .22 amended as an emergency provision effective May 1, 1999 (26:9 Md. R. 727 and 26:10 Md. R. 794); emergency status expired November 1, 1999 **Administrative History:** Regulation .22 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 **Administrative History:** Regulation .22 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; adopted permanently effective June 25, 2001 (28:12 Md. R. 1109) **Administrative History:** Regulation .22 amended effective December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .22A amended and F—J adopted effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Regulation .22C amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulations .24 and .25 adopted as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); adopted permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .24 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 25, 2000 **Administrative History:** Regulation .24 amended effective December 25, 2000 (27:25 Md. R.2281); December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .24-1 adopted as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); emergency status expired December 31, 2000 **Administrative History:** Regulation .26 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .27 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Chapter revised effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .01 repealed effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); April 28, 2014 (41:8 Md. R. 471); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .02G amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .02G, J, X amended effective November 7, 2016 (43:22 Md. R. 1221) **Administrative History:** Regulation .02K amended effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .02O, S amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .02V amended effective December 27, 2010 (37:26 Md. R. 1787) **Administrative History:** Regulation .02Z adopted effective November 5, 2007 (34:22 Md. R. 1977) **Administrative History:** Regulation .02CC amended effective October 5, 2009 (36:20 Md. R. 1528); March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .02DD adopted effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .02EE adopted effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .02K, L amended effective October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .02FF adopted effective October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .03 amended effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .03A, B amended effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .03B amended effective December 19, 2005 (32:25 Md. R. 1941); April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 27, 2010 (37:26 Md. R. 1787); February 6, 2012 (39:2 Md. R. 141); December 24, 2012 (39:25 Md. R. 1613); December 12, 2013 (40:24 Md. R. 2017); August 29, 2016 (43:17 Md. R. 955); November 7, 2016 (43:22 Md. R. 1221); December 31, 2018 (45:26 Md. R. 1245) **Administrative History:** Regulation .04B amended effective April 10, 2006 (33:7 Md. R. 668); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .04C amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .05I amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .05G amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .05K amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .06C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .08 amended effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .08C, E amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .08I amended effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .08K amended effective April 10, 2006 (33:7 Md. R. 668) **Administrative History:** Regulation .08M repealed effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .10C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .10D amended effective April 10, 2006 (33:7 Md. R. 668) **Administrative History:** Regulation .10E amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .10F amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .11 repealed effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .11E amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .11F amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .11G amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .11-1 repealed effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .11-2 repealed effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .12B amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .12D repealed effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .13F amended effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .14 amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .14A amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .15 amended effective February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .15B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .15C amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .15D amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .15E amended effective December 19, 2005 (32:25 Md. R. 1941); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .15F amended effective April 10, 2006 (33:7 Md. R. 668) **Administrative History:** Regulation .15L adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .16 repealed effective November 5, 2007 (34:22 Md. R. 1977) **Administrative History:** Regulation .17 amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .17A amended effective November 6, 2006 (33:22 Md. R. 1732); June 30, 2008 (35:13 Md. R. 1180); February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .17B amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); February 1, 2016 (42:23 Md. R. 1434) **Administrative History:** Regulation .18H amended effective November 5, 2007 (34:22 Md. R. 1977) **Administrative History:** Regulation .18I, J adopted effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .19 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634) **Administrative History:** Regulation .19 amended as an emergency provision effective April 1, 2005 (32:9 Md. R. 847); amended permanently effective July 18, 2005 (32:14 Md. R. 1276) **Administrative History:** Regulation .19 amended effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .19A, B amended as an emergency provision effective January 1, 2008 (35:3 Md. R. 286); amended permanently effective June 16, 2008 (35:12 Md. R. 1120) **Administrative History:** Regulation .19A amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .19B amended effective December 20, 2004 (31:25 Md. R.1790); December 19, 2005 (32:25 Md. R. 1941); April 10, 2006 (33:7 Md. R. 669) **Administrative History:** Regulation .19B amended as an emergency provision effective July 1, 2006 (33:20 Md. R. 1610); amended permanently effective October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .19B amended as an emergency provision effective January 1, 2007 (34:4 Md. R. 396); amended permanently effective April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .19B amended as an emergency provision effective September 14, 2007 (34:21 Md. R. 1911); amended permanently effective November 19, 2007 (34:23 Md. R. 2027) **Administrative History:** Regulation .19B amended effective January 12, 2009 (36:1 Md. R. 21); July 27, 2009 (36:15 Md. R. 1166); January 25, 2010 (37:2 Md. R. 67); June 14, 2010 (37:12 Md. R. 800); December 27, 2010 (37:26 Md. R. 1788); April 4, 2011 (37:8 Md. R. 431); April 30, 2012 (39:8 Md. R. 534); December 10, 2012 (39:24 Md. R. 1577); July 7, 2014 (41:13 Md. R. 752); February 16, 2015 (42:3 Md. R. 316); October 26, 2015 (42:21 Md. R. 1301); May 9, 2016 (43:9 Md. R. 530); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319); August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .19D amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 446); amended permanently effective May 24, 2004 (31:10 Md. R. 795) **Administrative History:** Regulation .19D amended effective June 14, 2010 (37:12 Md. R. 800); October 26, 2015 (42:21 Md. R. 1301); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .19-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .19-3 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .19-3 amended effective June 19, 2006 (33:12 Md. R. 997); April 9, 2007 (34:7 Md. R. 698); June 14, 2010 (37:12 Md. R. 800); April 30, 2012 (39:8 Md. R. 534) **Administrative History:** Regulation .19-3 repealed effective October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .19-3 adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .19-3A, B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .19-3A, B amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .19-3B amended effective December 24, 2012 (39:25 Md. R. 1613); February 3, 2014 (41:2 Md. R. 91) **Administrative History:** Regulation .19-3C amended effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .19-3C, D amended effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .19-5 adopted effective December 19, 2005 (32:25 Md. R. 1941) **Administrative History:** Regulation .19-5 repealed and new Regulation .19-5 adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .19-5F amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .19-5G amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .19-5H amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .20 amended effective August 8, 2011 (38:16 Md. R. 945); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .20A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .20A amended effective April 10, 2006 (33:7 Md. R. 668); November 5, 2007 (34:22 Md. R. 1977); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .20A, B amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .20A, D amended effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .20B, C amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .20C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .20E adopted effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulation .21 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .21 amended effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .21B amended effective June 19, 2006 (33:12 Md. R. 997); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .22 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .22C, D amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .23 amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .23C amended effective November 7, 2016 (43:22 Md. R. 1221) **Administrative History:** Regulation .23D amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .23D amended effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .24 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .24 repealed effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .25B amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .28 adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .28 amended effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .28 repealed effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Chapter transferred to COMAR 10.67.04 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 66 — Assistance in Community Integration Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: May 12, 2025 (52:9 Md. R. 405) #### Regulation .01 Definitions. *COMAR 10.09.66.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Assistance in Community Integration Services (ACIS)” means the ACIS program, a health related social needs benefit for qualified individuals, which is implemented in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services. (2) “Compliance activities” means tasks undertaken to ensure that ACIS is delivered in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services. (3) “Continuum of Care Program” means the regional or local planning body that coordinates housing and services funding for families and individuals experiencing homelessness. (4) “Homelessness” has the meaning stated in 24 CFR §578.3. (5) “Lead entity” means a local health department or local governmental agency, which: (a) Has been awarded participant spaces in the ACIS program; (b) Is an enrolled provider with the Maryland Medical Assistance Program; (c) Is responsible for leadership, coordination, oversight, and monitoring of ACIS; (d) Shall serve as the organizing hub and contact point for ACIS with all collaborators, including the participant’s MCO; and (e) Shall facilitate the financial arrangement and payments with designated subcontractors. (6) “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. (7) “Participant” has the meaning stated in COMAR 10.09.36.01. (8) “Program” means the Maryland Medical Assistance Program. #### Regulation .02 Conditions for Participation. *COMAR 10.09.66.02* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. A lead entity shall: (1) Have been awarded participant spaces for ACIS by the Program; and (2) Be a member of its local Continuum of Care Program. #### Regulation .03 Eligibility for Services. *COMAR 10.09.66.03* Eligibility for ACIS services under this chapter is limited to individuals who meet the following health and housing criteria: A. The individual is a participant that uses Maryland Medical Assistance; B. The individual meets at least one of the following health criteria: (1) Repeated emergency department visits; (2) Repeated hospital admissions in the past year; or (3) Two or more chronic conditions as defined in §1945(h)(2) of the Social Security Act; and C. The individual meets at least one of the following housing criteria: (1) Is homeless, chronically homeless, or at risk of homelessness as defined in 24 CFR §578.3; or (2) Is at risk of institutional placement. #### Regulation .04 Covered Services. *COMAR 10.09.66.04* A. The Program shall cover the following ACIS services: (1) Compliance activities; and (2) Housing and tenancy-based case management services when three or more services, as specified in §B of this regulation, are delivered per month per participant. B. Housing and tenancy-based case management services include the following: (1) Community integration assessments to identify the participant’s: (a) Housing preferences; (b) Needs for support to maintain community integration; (c) Budgeting needs; (d) Needs for assistance applying for social services; and (e) Needs for support regarding understanding and meeting obligations of tenancy; (2) The development of a person-centered community integration plan with enumerated measurable goals inclusive of review and modification of the plan when necessary; (3) Participation in meetings related to: (a) Housing support; (b) Crisis management; and (c) Person-centered planning; (4) Assistance in connecting individuals with social services defined in the integration plan such as: (a) Housing required to meet the participant’s medical care needs; (b) Independent living services; (c) Counseling services; (d) Employment support services; (e) Services required to meet the participant’s medical needs; (f) Transportation for services; and (g) Entitlement programs; (5) Assistance in communication with property managers or landlord for accommodation needs; and (6) Connecting the participant to training and resource support related to being housed and household management. #### Regulation .05 Limitations. *COMAR 10.09.66.05* A. Under this chapter, the Program does not cover the following: (1) Services provided to or for the primary benefit of individuals other than the participant; (2) Services rendered but not appropriately documented; and (3) Room and board. B. Providers may not bill for monthly ACIS case-management services if less than three housing and tenancy-based case management services were rendered to the participant for the month. C. Providers may not bill for compliance activities more than once per participant per calendar year. #### Regulation .06 Payment Procedures. *COMAR 10.09.66.06* A. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. B. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. C. Payments for services rendered to a participant shall be made directly to the qualified lead entity. D. Effective January 1, 2025, rates for the services outlined in this chapter shall be as follows: (1) $725 per member per month for ACIS housing and tenancy-based case management; and (2) $100 per member per year for compliance activities. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.66.07* Recovery and reimbursement regulations are as set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.66.08* Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08 #### Regulation .09 Appeal Procedures. *COMAR 10.09.66.09* Providers filing appeals from administrative decisions made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.66.10* Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. ### Chapter 67 — Maryland Medicaid Managed Care Program: Benefits *Transferred to COMAR 10.67.06* **Administrative History:** Effective date: **Administrative History:** Regulations .01—.30 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .01 amended effective December 27, 2010 (37:26 Md. R. 1787); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .01A amended effective November 6, 2006 (33:22 Md. R. 1732); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .01B amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .01C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .01C amended effective August 16, 2004 (31:16 Md. R. 1255) **Administrative History:** Regulations .01D, .04, .06, .07B, .10, .13, .21A, and .28 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .01D amended effective December 19, 2005 (32:25 Md. R. 1941); October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .01G adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .02 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .03A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .03A amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .04 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .04A, C amended effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .04A, D amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .04C amended effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .04D amended effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .04G, H adopted effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .05 amended effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .05A amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .06 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); amended permanently effective December 25, 2000 (27:25 Md. R. 2281) **Administrative History:** Regulation .06 repealed effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .06A amended effective February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) **Administrative History:** Regulations .07, .09, .10, and .27 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 **Administrative History:** Regulation .06 adopted effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .07B amended effective December 24, 2012 (39:25 Md. R. 1613); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .07F adopted effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .07F amended effective April 10, 2006 (33:73 Md. R. 668) **Administrative History:** Regulation .07G adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .07H adopted as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .07I adopted effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .08 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .09 amended effective February 9, 1998 (25:3 Md. R. 144); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .10 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .10 repealed effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .10A amended effective February 2, 2004 (31:2 Md. R. 82); November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .10C amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 445); amended permanently effective April 12, 2004 (31:7 Md. R. 584) **Administrative History:** Regulation .10C repealed effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .11 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .11B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .11B amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .12 amended effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .12 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .12 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .12 amended effective November 6, 2006 (33:22 Md. R. 1732); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .13A amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .13D adopted effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .14A, C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .14C amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .15 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .15 amended effective November 6, 2006 (33:22 Md. R. 1732); November 7, 2016 (43:22 Md. R. 1221) **Administrative History:** Regulation .16 amended effective December 23, 2002 (29:25 Md. R. 1981); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .17 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .18 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .19 amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); February 26, 2018 (45:4 Md. R. 205); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .20A amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144); February 18, 2002 (29:3 Md. R. 220); April 10, 2006 (33:7 Md. R. 668); December 24, 2012 (39:25 Md. R. 1613); April 28, 2014 (41:8 Md. R. 471); February 27, 2017 (44:4 Md. R. 252); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .21A amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .21D amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .22 amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .23 amended effective February 18, 2002 (29:3 Md. R. 220); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .24 amended effective October 28, 2013 (40:21 Md. R. 1775); August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .24A, C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .24C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .25 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .26 amended effective November 6, 2006 (33:22 Md. R. 1732); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .26-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .26-2 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .26-3 adopted effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulation .26-4 adopted effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .26-5 adopted effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .27 amended effective December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .27A amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .27B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .27B amended as an emergency provision effective March 9, 1998 (25:7 Md. R. 525); amended permanently effective June 15, 1998 (25:12 Md. R. 947) **Administrative History:** Regulation .27B amended effective November 1, 1999 (26:22 Md. R. 1692); December 25, 2000 (27:25 Md. R. 2281); December 23, 2002 (29:25 Md. R. 1981); February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) **Administrative History:** Regulation .27B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .27B amended effective April 10, 2006 (33:73 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .28 amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316); April 10, 2017 (44:7 Md. R. 355) **Administrative History:** Regulation .28D amended effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .28G amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .28H repealed effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .28H adopted effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .28H amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .28I adopted effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .28I, J amended effective October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .28K adopted effective October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .29E—G adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .30 repealed effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .31 adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Chapter transferred to COMAR 10.67.06 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 68 — Maryland Medicaid Managed Care Program: Program Integrity *Transferred to COMAR 10.67.07* **Administrative History:** Effective date: February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .01L amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .01N adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred to COMAR 10.67.07 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 69 — Maryland Medicaid Managed Care Program: Rare and Expensive Case Management **Authority:** Health-General Article, §§2-104(b), 15-103(b)(4)(i), and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.17 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) **Administrative History:** Regulations .01—.17 adopted effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulations .01, .02, .05, .06, .08—.11, and .13 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 **Administrative History:** Regulation .01 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulations .01, .02, and .14 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261) **Administrative History:** Regulations .01, .02, .09, .10, and .14 amended effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .01O amended effective October 16, 2000 (27:20 Md. R. 1839) **Administrative History:** Regulation .02 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .02 repealed as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; repealed permanently effective June 25, 2001 (28:12 Md. R. 1109) **Administrative History:** Regulation .03 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109) **Administrative History:** Regulation .04 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109) **Administrative History:** Regulation .05 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .05 amended as an emergency provision effective December 1, 2000 (27:26 Md. R. 2355); emergency status extended at 28:7 Md. R. 685; amended permanently effective June 25, 2001 (28:12 Md. R. 1109) **Administrative History:** Regulation .06B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .08 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .09B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .10B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .11B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .13B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulations .01—.17 repealed and new Regulations .01—.17 adopted effective February 2, 2004 (31:2 Md. R. 84) **Administrative History:** Regulation .02B amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .04 amended effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .05B, C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .05C, D amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .07G amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .09 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .12B amended effective November 5, 2007 (34:22 Md. R. 1977) **Administrative History:** Regulation .12C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .13B, C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .13C amended effective October 14, 2013 (40:20 Md. R. 1652) **Administrative History:** Regulation .14E, F, G adopted effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .14E amended effective April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .17 amended effective November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); October 5, 2009 (36:20 Md. R. 1528); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .17 repealed and new Regulation .17 adopted effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Chapter revised effective July 2, 2018 (45:13 Md. R. 665) **Administrative History:** Regulation .02B amended effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .04F amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .04K, L adopted effective November 23, 2023 (50:23 Md. R. 1005) **Administrative History:** Regulation .11A amended effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .12 amended effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .14 amended effective November 14, 2022 (49:23 Md. R. 996); November 23, 2023 (50:23 Md. R. 1005) **Administrative History:** Regulation .14D, E amended effective May 20, 2019 (46:10 Md. R. 486); November 18, 2019 (46:23 Md. R. 1065) **Administrative History:** Regulation .17 amended effective May 20, 2019 (46:10 Md. R. 486); November 14, 2022 (49:23 Md. R. 996); November 23, 2023 (50:23 Md. R. 1005) #### Regulation .01 Purpose. *COMAR 10.09.69.01* A. The purpose of the Rare and Expensive Case Management (REM) program is to provide case management services and subspecialty care for Maryland Medicaid Managed Care Program eligible individuals with rare and expensive conditions. B. The program is designed to provide Maryland Medicaid Managed Care Program eligible individuals diagnosed with qualifying rare and expensive conditions the following benefits when the individual elects to participate in the program: (1) Case management services; and (2) REM optional services. #### Regulation .02 Definitions. *COMAR 10.09.69.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means tasks or activities that include but are not limited to bathing, feeding, toileting, dressing, and ambulation. (2) “Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed. (3) “Caregiver” means a willing and able individual who is trained in providing care to the participant. (4) “Case management” means assessing, planning, coordinating, and monitoring the delivery of medically necessary health-related services. (5) “Case management provider” means the Department's designee, or a subcontractor of the designee, which provides case management to participants assigned to it by the Department. (6) “Case manager” means, an individual who is: (a) A social worker with active and nationally recognized certification in case management or an RN; (b) Employed by the Department's designee; and (c) Assigned by the Department's designee to manage the care of some or all of the participants. (7) “Cause” means a significant change in medical condition such that it is no longer medically efficacious for the individual to remain in the MCO as determined by the Department. (8) “Certified medication technician (CMT)” means an individual who: (a) Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing; (b) Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and (c) Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. (9) “Certified nursing assistant (CNA)” means an individual who: (a) Is certified by the Maryland Board of Nursing under COMAR 10.39.05; and (b) Routinely performs nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. (10) “Certified nursing assistant certified as a CMT (CNA-CMT)” means an individual who: (a) Is certified by the Maryland Board of Nursing under COMAR 10.39.05 and 10.39.04; (b) Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing; and (c) Routinely performs nursing tasks including medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. (11) “Chiropractor” means an individual who is licensed by the Maryland State Board of Chiropractic Examiners to practice chiropractic in Maryland. (12) “Delegated nursing services” means nursing services provided to a participant by a CNA, CNA-CMT, HHA, or HHA-CMT under the supervision of an RN in accordance with COMAR 10.27.11. (13) “Dental service provider” means an individual who is licensed and legally authorized to practice dentistry in the state in which the service is provided. (14) “Department” means the Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. (15) “Dietitian-nutritionist” means an individual who is licensed as a dietitian-nutritionist by the Maryland State Board of Dietetic Practice to practice dietetics in Maryland. (16) “Early and periodic screening, diagnosis, and treatment (EPSDT)” means the provision, to individuals younger than 21 years old, of preventive health care pursuant to 42 CFR §441.50 et seq., as amended, and other health care services, diagnostic services, and treatment services that are necessary to correct or ameliorate defects, physical and mental illnesses, and conditions discovered by EPSDT screening services. (17) “EPSDT-certified provider” means a physician, physician assistant or nurse practitioner who is certified by the Department's EPSDT program to provide well-child services according to the Department's periodicity schedule and program standards to enrollees younger than 21 years old. (18) “EPSDT periodicity schedule” means the list approved by the Department of required or recommended preventive health care services for children and adolescents. (19) “EPSDT services” means: (a) Screening services provided by an EPSDT-certified provider that are required or recommended on the EPSDT periodicity schedule; and (b) Health care services performed to diagnose, treat, or refer problems or conditions discovered during the comprehensive well-child service. (20) “Evaluation” means a determination of the health status of a patient in a patient's home or any other appropriate setting by a licensed professional for the purpose of designing an individual plan of care, which incorporates the modalities of treatment that will promote optimal functional ability and recuperation. (21) “Family member” means an adult who: (a) Lives with or provides care to the participant; and (b) Is not paid to provide the care under the REM program. (22) “HealthChoice” means Maryland Medicaid's Statewide mandatory managed care program as defined in COMAR 10.67.04. (23) “Home” means the place of residence, occupied by the participant, other than a residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment. (24) “Home health agency” means an agency licensed by the Department in accordance with COMAR 10.07.10. (25) “Home health aide (HHA)” means an individual who meets all the conditions of participation specified in: (a) 42 CFR §484.36; and (b) Health Occupations Article, Title 8, Annotated Code of Maryland. (26) “Home health aide certified as a CMT (HHA-CMT)” means an individual who: (a) Meets all the conditions of participation specified in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland; and (b) Completes a 20-hour course in medication administration approved by the Maryland Board of Nursing. (27) “Hospital” means an institution licensed by and providing services in accordance with Health-General Article, §19-301, Annotated Code of Maryland. (28) “Individualized education program (IEP)” means a written description of special education and related services developed by an IEP team to be implemented to meet the individual needs of a child. (29) “Individualized family service plan (IFSP)” means a written plan for providing early intervention and other services to an eligible child and the child's family developed by an IFSP team. (30) “Interdisciplinary team" means the group comprised of the case manager and relevant service providers to develop the case management plan under the overall direction and coordination of the case manager, in consultation with the participant and, when applicable, the participant's family. (31) “Intermediate care facility for individuals with intellectual disabilities or individuals with related conditions (ICF-IID)” means an institution licensed by the Department under COMAR 10.07.20 that provides health-related services or health rehabilitative services for individuals with intellectual disabilities or related conditions. (32) “Licensed practical nurse (LPN)” means an individual licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. (33) “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. (34) “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for categorically eligible and medically needy individuals. (35) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, the participant's family, or the provider. (36) “Medicare” means the federal program that provides benefits to the aged and disabled under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (37) “Nurse” means an individual who is licensed to practice as a registered nurse (RN) or a licensed practical nurse (LPN) in the jurisdiction in which services are provided. (38) “Nurse practitioner” means an individual who is licensed and certified to practice as a nurse practitioner in the jurisdiction in which services are provided. (39) “Nursing facility” has the meaning stated in COMAR 10.09.10.01B. (40) “Nutritional counseling” means the assessment of the participant's nutritional status and education about improving their nutritional status provided by a licensed dietitian-nutritionist. (41) “Nutritional supplements” means enteral feeding which is medically indicated as either the sole source of nutrition or a supplement that enhances the physical well-being of the participant. (42) “Occupational therapist” means an individual licensed by the Maryland State Board of Occupational Therapy Practice to practice occupational therapy in Maryland. (43) “Participant” means an eligible individual who is enrolled in the Program. (44) “Physician” means an individual who is licensed or otherwise legally authorized to practice in the jurisdiction in which the services are rendered. (45) “Physician assistant” means an individual who is licensed to practice medicine with physician supervision as stated in the Health Occupations Article, §§15-301(d) and (e) and 15-302, Annotated Code of Maryland. (46) “Plan of care” means the document which governs a participant's care management which includes the: (a) Case management assessment report; (b) Interdisciplinary plan of care; and (c) Case management plan. (47) “Preauthorization” means the approval required from the Department or its designee before specific services may be rendered. (48) “Primary care provider (PCP)” means a physician, physician assistant, or nurse practitioner who is the primary coordinator of care for the participant, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medicaid Managed Care Program, as specified in COMAR 10.67.06. (49) “Private duty nursing” means skilled nursing services for participants, who require more individual and continuous care than is available under the home health program, which are provided by a registered nurse (RN) or a licensed practical nurse (LPN), in a participant's home or another setting when normal life activities take the participant outside his or her home. (50) “Program”, unless the context indicates otherwise, has the meaning stated in COMAR 10.09.36.01B. (51) “Progress note” means a signed and dated written notation by the RN, LPN, CNA, CNA-CMT, HHA, or HHA-CMT, which: (a) Summarizes facts about the care given and the participant's response during a given period of time; (b) Specifically addresses the established goals of treatment; (c) Is consistent with the participant's plan of care; and (d) Is written during the course of care. (52) “Provider” means an individual, agency, or facility, which is enrolled in the Program through an agreement with the Department, and has been identified as a Program provider by the issuance of a provider number. (53) “Rare and expensive case management (REM)” means a Maryland Medical Assistance program that provides case management services and optional services to eligible individuals with specific rare and expensive conditions. (54) “Rare and expensive condition” means a medical diagnosis or condition identified in Regulation .16 of this chapter. (55) “Registered nurse (RN)” means an individual licensed to practice registered nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. (56) “REM optional services” means the services listed in Regulations .10 and .11 of this chapter, which meet the general requirements under Regulation .09 of this chapter. (57) “Residential service agency” means an agency licensed by the Department in accordance with COMAR 10.07.05. (58) “Residential treatment center” means any institution which falls within the jurisdiction of Health-General Article, §19-308, Annotated Code of Maryland, and is licensed as required by COMAR 10.07.04 or other applicable standards established by the state in which the service is provided. (59) “School” means courses or classes for the acquisition of a General Education Diploma, a high school diploma, an associate degree, or a first-time bachelor’s degree. (60) “Social worker” means an individual who is licensed by the Maryland State Board of Social Work Examiners to practice social work in Maryland. (61) “Speech-language pathologist” means an individual who is licensed by the Maryland Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists to practice speech-language pathology in Maryland. #### Regulation .03 REM Eligibility. *COMAR 10.09.69.03* A. An individual is eligible to participate in the REM program if the individual: (1) Is eligible for Maryland Medicaid Managed Care as specified in COMAR 10.67.02.01; (2) Has one or more of the diagnoses specified in Regulation .17 of this chapter; and (3) Elects to participate in the REM program. B. The Department shall render a determination of an individual's eligibility within 5 business days on receipt of: (1) A completed REM application; (2) Any requested documentation verifying an individual meets the criteria set forth in §A of this regulation; and (3) Verbal or written confirmation an individual elects to participate. #### Regulation .04 Participant Enrollment and Disenrollment. *COMAR 10.09.69.04* A. Anyone may refer an individual into the REM program including, but not limited to a: (1) Family member; (2) Physician; (3) Discharge planner; (4) Hospital; (5) Clinic; (6) Social worker; and (7) Managed care organization (MCO). B. The Department shall enroll an individual determined eligible in the REM program when: (1) All pertinent documentation regarding needed medical services is received, reviewed, and approved; (2) Confirmation of the individual's election to participate in the program is received; and (3) The individual is being discharged from an institution or transitioning from an MCO and service coordination is complete. C. When an MCO participant is referred to the REM program for enrollment, the MCO shall: (1) Provide confirmation of the qualifying diagnosis to the Department; and (2) Continue to provide the MCO participant's care until the Department confirms the diagnosis and enrolls the MCO participant into REM. D. An individual shall be enrolled in or auto-assigned into an MCO as specified in COMAR 10.67.02, not later than 60 days from the date the individual becomes ineligible for REM, as a result of changes in the diagnosis or age group criteria specified in Regulation .17 of this chapter, except when the individual was allowed to remain in REM in accordance with §I of this regulation. E. A REM participant may elect to disenroll from REM and enroll in an MCO by notifying the Department of that decision except when the individual was allowed to remain in REM in accordance with §I of this regulation. F. Election to Remain in MCO. (1) An individual who becomes eligible for REM while enrolled in an MCO may elect to remain in an MCO by notifying the Department of that decision. (2) When a REM-eligible individual elects to remain in an MCO, the Department, in consultation with the MCO and the REM-eligible individual, may determine whether the MCO can appropriately meet the individual's medical needs within the parameters of the program benefit package as described in COMAR 10.67.06. (3) If the MCO determines it cannot appropriately meet the individual's medical needs, the MCO shall submit to the Department written justification for its decision. (4) If the Department determines the MCO can meet the individual's medical needs, the Department shall notify the MCO of its decision in writing. (5) If the Department determines that the MCO cannot appropriately meet the individual's needs, the Department shall issue a written determination to the individual and the MCO which includes: (a) The reason for the determination; and (b) An explanation of the individual's right to appeal the determination according to the procedures set forth in COMAR 10.01.04. (6) If the Department determines that the MCO can appropriately meet the individual's medical needs, the individual's election becomes effective and cannot be revoked without cause for a period of 1 year from the effective date. G. The Department shall allow an individual who, immediately before enrollment in REM, was receiving medical services from a specialty clinic or other setting to continue to receive services in that setting on enrollment in the REM program when the provider is willing to participate as a Medical Assistance fee-for-service provider. H. An individual eligible for REM who has elected to enroll in an MCO or to remain enrolled in an MCO may not receive REM services under the REM program. I. The Department shall disenroll from the REM program a participant who no longer meets the conditions specified in Regulation .03 of this chapter unless: (1) The participant does not meet the condition under Regulation .03A(1) of this chapter because the participant becomes eligible for Medicare; and (2) At the time the participant became eligible for Medicare the participant was approved for and was receiving private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services under the REM program. J. An individual disenrolled from REM by the Department who maintains HealthChoice eligibility is subject to the MCO enrollment provisions specified in COMAR 10.67.02 except when the individual was allowed to remain in REM in accordance with §I of this regulation. K. Department-Initiated Disenrollment. The Department shall disenroll from REM an enrollee: (1) Who has been continuously institutionalized for a period of more than 90 successive days in a long-term care facility, subject to the long-term care facility obtaining the Department’s determination that the enrollee’s institutionalization has been medically necessary; (2) Who has been, or is expected to be, continuously institutionalized for more than 30 successive days in an institution for mental disease (IMD); (3) Upon admission to an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID); (4) Who loses Medicaid eligibility or who changes to an assistance category not eligible for MCO enrollment, subject to COMAR 10.67.02; (5) Who has died; or (6) Who is an inmate of a public institution, including a State-operated institution or facility. L. Effective Date of Disenrollment. An enrollee’s disenrollment shall take effect: (1) Immediately when the enrollee dies; (2) From the first day of the month following the month in which the enrollee lost Medicaid eligibility; (3) On the first day of the month following the month in which the Department receives the required notification, when the enrollee permanently relocates outside of the State; or (4) From the first day of the month following the month in which the Department verifies an enrollee is an inmate. #### Regulation .05 Benefits. *COMAR 10.09.69.05* A REM participant is eligible for the following: A. Fee-for-service Medical Assistance benefits available to a Medical Assistance participant not enrolled in an MCO; B. Services described in Regulations .10 and .11 of this chapter when determined medically necessary by the Department; C. A case management assessment performed by a REM case manager who shall: (1) Gather all relevant information needed to determine the participant’s condition and needs including the participant’s medical records; (2) Consult with the participant's current service providers; and (3) Evaluate the relevant information and complete a needs analysis including medical, psychosocial, environmental, and functional assessments; and D. Case management services performed by a REM case manager who shall: (1) When necessary, assist the REM participant, offering the participant a choice, if possible, in selecting and obtaining a PCP, who may be a specialist to the participant’s condition, giving preference to any pre-established relationships between the participant and the participant’s PCP; (2) Develop a plan of care in consultation with the participant, the participant's family members as authorized by the participant when possible, the PCP, and other providers rendering care that: (a) Includes the participant's health status and needs for medical, health-related, housing, and social services including, but not limited to: (i) All pertinent diagnoses including the REM qualifying diagnosis; (ii) Type, frequency, and duration of services; (iii) Treatment goals for each type of service; (iv) Medical equipment and supplies; (v) Medication; (vi) Social support structure; (vii) Current service providers; (viii) Assigned level of care; (ix) Nutritional status; (x) Education or vocational information; (xi) Current living arrangement; and (xii) Emergency plan, if appropriate; and (b) Is developed in consultation with the interdisciplinary team; (3) Implement the plan of care and assist the participant in gaining access to medically necessary services by linking the participant to those services; (4) Monitor service delivery, perform record reviews, and maintain contacts with the participant, services providers, and family members to evaluate the participant's condition and progress and to determine whether revision is needed in the plan of care or in services' delivery; (5) As necessary, initiate and implement modifications to the plan of care and communicate these changes to the participant, parents or caregivers, and pertinent health care providers; (6) Monitor a participant's receipt of EPSDT services as specified in COMAR 10.67.06; and (7) Assist the participant with the coordination of school health-related services such as the IEP or the IFSP as described in COMAR 10.09.50. #### Regulation .06 Requirements for Provider Qualification. *COMAR 10.09.69.06* A. A case manager providing case management under this chapter shall be: (1) An RN; or (2) A social worker. B. The following professionals providing services under this chapter to REM participants shall be licensed, certified, or otherwise legally authorized to practice in the jurisdiction in which the services are rendered: (1) Physicians; (2) Physician Assistants; (3) Nurse Practitioners; (4) RNs and LPNs; (5) Chiropractors; (6) Dentists; (7) Dietitian-Nutritionists; (8) Occupational therapists; (9) Social workers; (10) Speech-language pathologists; and (11) CNAs, HHAs, CNA-CMTs, and HHA-CMTs. C. A provider rendering services pursuant to this chapter shall meet all applicable licensure and certification requirements of the jurisdiction in which the provider is providing services. D. A provider rendering services to REM participants, pursuant to this chapter, may not have current sanctions or current disciplinary actions imposed by: (1) The jurisdictional licensing or certification authority; (2) The Medicare Program; (3) The Program; or (4) Other federally funded healthcare programs. #### Regulation .07 Conditions for Participation — General Requirements. *COMAR 10.09.69.07* A provider rendering services pursuant to this chapter shall: A. Meet the applicable conditions for participation set forth in COMAR 10.09.36; B. Meet the provider qualification requirements specified in Regulation .06 of this chapter for its provider type; C. Meet the specific conditions for provider participation set forth in this chapter; D. Provide services in accordance with the applicable requirements of this chapter and all other relevant State and local laws and regulations; E. Verify the qualifications of all subcontracted or employed professionals and individuals engaged by the provider agency to render services covered under this chapter and provide a copy of their current licensure and credentials on request to the Department; F. Provide services to REM program participants in a manner consistent with the REM participant’s plan of care; and G. When the Department determines it is necessary, participate in the interdisciplinary team meetings for the purpose of: (1) Developing and implementing a participant's treatment plan or plan of care with the Department; or (2) Accessing a specific service. #### Regulation .08 Specific Conditions for Provider Participation. *COMAR 10.09.69.08* A. Case Management Providers. To participate in the Program, a case management provider shall meet the conditions set forth in Regulations .06 and .07 of this chapter. B. Chiropractic Service Providers. To participate in the Program, the chiropractic service provider shall: (1) Meet the: (a) Conditions set forth in Regulation .07 of this chapter; and (b) Requirements for chiropractic providers specified in COMAR 10.43.04; (2) Develop a goal-directed treatment plan that is based on an evaluation conducted during the initial assessment, which requires: (a) A review or evaluation of the treatment plan 30 days after the initial assessment; and (b) A review and update of the treatment plan every 90 days; and (3) Render services in accordance with orders written by a physician, physician assistant, or nurse practitioner. C. Dental Service Providers. To participate in the Program, the dental service provider shall meet the: (1) Conditions set forth in Regulation .07 of this chapter; and (2) Requirements for dental providers specified in COMAR 10.09.05. D. Nutritional Supplement Providers. To participate as a provider of nutritional supplements, a provider shall meet the: (1) Conditions of participation as set forth in Regulation .07 of this chapter; and (2) Criteria of the conditions for participation for pharmacy providers set forth in COMAR 10.09.03. E. Shift Private Duty Nursing/CNA/CNA-CMT/HHA/HHA-CMT Providers. To participate as a provider agency for shift private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services, a provider shall: (1) Meet the conditions set forth in Regulation .07 of this chapter; (2) Meet all requirements of conditions for participation set forth in COMAR 10.09.53.03; (3) Participate in interdisciplinary team meetings, when requested by the Department or its designee; (4) Develop a goal-directed written nursing care plan that is based on an evaluation conducted during the initial assessment, which requires: (a) A review or evaluation of the nursing care plan 30 days after the initial assessment; and (b) A review and update of the nursing care plan every 90 days; (5) Ensure timesheets are signed by the individual rendering services; (6) Ensure a nurse's, CNA’s, CNA-CMT’s, HHA’s, or HHA-CMT’s shift to be not more than a total of 60 hours per week or 16 consecutive hours and that the individual is off 8 or more hours before starting another shift unless otherwise authorized by the Department; (7) Obtain the participant's signature or the signature of the participant's witness on the provider's official forms to verify receipt of service; and (8) Be licensed as a: (a) Residential service agency in accordance with COMAR 10.07.05; or (b) Home health agency in accordance with COMAR 10.07.10 which meets the conditions of participation specified by the Medicare program in 42 CFR §484.36. F. Occupational Therapy Providers. To participate in the Program as a provider of occupational therapy services, a provider shall: (1) Meet the conditions set forth in Regulation .07 of this chapter; (2) Be a self-employed occupational therapist licensed according to COMAR 10.46.01; (3) Be an agency or clinic which employs occupational therapists or be a Program provider of home health services under COMAR 10.09.04; and (4) Develop a goal-directed written treatment plan that is based on an evaluation conducted during the initial assessment which requires: (a) A review or evaluation of the treatment plan 30 days after the initial assessment; and (b) A review and update of the treatment plan every 90 days. G. Speech-Language Pathology Providers. To participate in the Program, a speech-language pathology provider shall: (1) Meet the conditions set forth in Regulation .07 of this chapter; (2) Be a self-employed speech-language pathologist according to COMAR 10.41.03 or be a Program provider of home health services under COMAR 10.09.04; (3) Be an agency or clinic that employs speech-language pathologists; and (4) Develop a goal-directed written treatment plan that is based on an initial assessment, which requires: (a) A review or evaluation of the treatment plan 30 days after the initial assessment; and (b) A review and update of the treatment plan every 90 days. #### Regulation .09 Covered Services — General Requirements. *COMAR 10.09.69.09* For participants in the REM program, the Program covers and shall reimburse for services specified in Regulations .10 and .11 of this chapter when these services are: A. Medically necessary; B. Prescribed by a: (1) Physician; (2) Physician assistant; or (3) Nurse practitioner; C. Preauthorized, when required, by the Department; D. Rendered in accordance with accepted health professional standards; E. Rendered in accordance with the treatment plan or physician's, physician assistant’s, or nurse practitioner’s order, or both; and F. Delivered by an enrolled Medical Assistance provider. #### Regulation .10 Covered Services. *COMAR 10.09.69.10* A. Chiropractic services are covered for REM participants when: (1) Services are provided to a REM participant who is 21 years old or older; (2) Services are provided by a physician or chiropractor; (3) The qualifying REM diagnosis or related illness shows deterioration or worsening symptoms and other traditional treatments have been ineffective; (4) The treatment enhances or restores the participant's level of functioning; or (5) Symptoms resulting from the REM diagnosis or related illness impairs a participant's activities of daily living. B. Dental services are covered when services are: (1) Provided to a REM participant who is 21 years old or older; and (2) Rendered as specified in COMAR 10.09.05. C. Nutritional counseling services are covered when services are provided: (1) To a REM participant who is 21 years old or older; and (2) By a dietitian-nutritionist. D. Nutritional supplements are covered when the services: (1) Include nutritional supplements or enteral feeding when medically necessary other than those administered by tube; and (2) Are as described in COMAR 10.09.03. E. The Department shall cover a physician's, physician assistant’s, or nurse practitioner’s participation at interdisciplinary team meetings when the case manager, in conjunction with the team or specific team members, convenes the team meeting for the purpose of developing or reviewing the REM participant's plan of care to ensure continuity of care or access to a specific service. F. Occupational therapy services are covered when services are provided: (1) To a REM participant who is 21 years old or older; (2) By an occupational therapist; and (3) In accordance with COMAR 10.46.01 and 10.46.02. G. Speech-language pathology services include only those services that are provided: (1) To a REM participant who is 21 years old or older; (2) By a speech-language pathologist; and (3) In accordance with COMAR 10.41.02 and 10.41.03. #### Regulation .11 Covered Optional Services — Private Duty Nursing, Certified Nursing Assistant, Certified Nursing Assistant Certified as a Certified Medication Technician, Home Health Aide and Home Health Aide Certified as a Certified Medication Technician. *COMAR 10.09.69.11* A. The Program shall cover shift nursing services provided by an RN or LPN when: (1) The services are more individualized and continuous than what is available under the home health program; (2) The services are delivered to the participant in the participant's home, in school, or in other normal life activity setting or settings which occur outside the participant's home; (3) Services are provided to a REM participant who is 21 years old or older; (4) Services are determined medically necessary for a participant after the provider has completed an initial nursing assessment that reflects the participant’s need for an awake and alert caregiver; (5) The participant has at least one caregiver willing and able to accept responsibility for the participant’s care when the nurse, CNA, or HHA is not available; (6) The caregiver provides documentation of each of the following when applicable: (a) The caregiver’s work schedule along with commuting times; (b) The caregiver’s school attendance as defined in Regulation .02 of this chapter along with commuting times; and (c) Emergency circumstances, as determined by the Department, including but not limited to the inability of the primary caregiver to provide care due to hospitalization or an acute debilitating illness for up to a 60-day period; (7) Services are provided only in the absence of the willing and able caregiver during the sleeping hours and during the times documented in §A(6) of this regulation; (8) Services are rendered in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland; (9) Sufficient documentation concerning the services provided is maintained by the RN or LPN including: (a) Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and (b) Signed and dated progress notes which are reviewed monthly by the RN supervisor; (10) The nurse's shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the nurse is off 8 or more hours before starting another shift unless otherwise authorized by the Department; (11) Services are rendered by an RN or an LPN who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; and (12) Monthly supervisory visits of an RN or an LPN are: (a) Conducted and documented by an RN supervisor; and (b) Based on acceptable standards of practice. B. The Program shall cover service`s provided by a CNA or CNA-CMT when: (1) The CNA or CNA-CMT is certified by the Maryland Board of Nursing and meets all the requirements to render services pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; (2) The CNA-CMT has completed the training and has been certified by the Maryland Board of Nursing as a CMT; (3) Services are of a scope that is more individual and continuous than what is available under the home health program; (4) The services provided include but are not limited to: (a) Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or (b) Other health care services properly delegated by an RN or an LPN pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; (5) Services are rendered by a CNA or CNA-CMT who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; (6) The CNAs or CNA-CMTs shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the CNA or CNA-CMT has 8 hours or more off before starting another shift unless otherwise authorized by the Department; (7) Sufficient documentation concerning the services provided is maintained by the CNA or CNA-CMT including: (a) Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and (b) Signed and dated progress notes which are reviewed every 2 weeks by the RN supervisor; (8) Supervisory visits are conducted and documented every 2 weeks by an RN; (9) The services are included in the REM participant's plan of care developed by the case manager; and (10) Services are preauthorized by the Department. C. The Program shall cover services provided by a HHA or HHA-CMT when: (1) Services are provided by an unlicensed individual who meets all the conditions of participation specified by the Medicare program in 42 CFR §484.36 and Health Occupations Article, Title 8, Annotated Code of Maryland; (2) The HHA-CMT has completed the training and has been certified by the Maryland Board of Nursing as a CMT; (3) Services are more individualized and continuous than what is available under the home health program; (4) The services provided include but are not limited to: (a) Assistance with activities of daily living when performed in conjunction with other delegated nursing services; or (b) Other health care services properly delegated by an RN or LPN pursuant to Health Occupations Article, Title 8, Annotated Code of Maryland; (5) Services are rendered by a HHA or HHA-CMT who is certified in cardiopulmonary resuscitation and the certification is renewed every 2 years; (6) The HHAs or HHA-CMTs shift is limited to not more than a total of 60 hours per week or 16 consecutive hours and the HHA or HHA-CMT has 8 hours or more off before starting another shift unless otherwise authorized by the Department; (7) Sufficient documentation is maintained by the HHA or HHA-CMT including: (a) Verification of the participant's receipt of services as documented by the participant's signature or the signature of the participant's witness on the provider's official forms; and (b) Signed and dated progress notes which are reviewed every 2 weeks by the RN supervisor; (8) Supervisory visits are conducted and documented every 2 weeks by an RN; (9) The services are included in the REM participant's plan of care developed by the case manager; and (10) Services are preauthorized by the Department. #### Regulation .12 Limitations. *COMAR 10.09.69.12* A. The Department shall pay for services specified in this chapter delivered to a REM participant only if the services have been ordered by the participant's physician or nurse practitioner, and preauthorized, when necessary, by the Department or its designee. B. For REM participants, the Department may not pay for the following comparable case management services: (1) HIV targeted case management as described in COMAR 10.09.32, except for HIV Diagnostic Evaluation Services as described in COMAR 10.09.32.03C and .04A; and (2) Model Waiver case management as described in COMAR 10.09.27. C. The REM program does not cover the following: (1) Shift private duty nursing, CNA or CNA-CMT, or HHA or HHA-CMT services rendered by a nurse, CNA, HHA, CNA-CMT, or HHA-CMT who is a member of the participant's immediate family or who ordinarily resides with the participant; (2) Services which are not medically necessary; (3) Services not supervised by an RN when delivered by the following: (a) An RN or an LPN; (b) A CNA; (c) An HHA; (d) A CNA-CMT; or (e) An HHA-CMT. (4) REM optional services not preauthorized as required by the Department or its designee; (5) REM optional services not prescribed by the participant's physician, physician assistant, or nurse practitioner; (6) Services specified in this chapter which duplicate or supplant services rendered by the participant's family caregivers or primary caregivers as well as other insurance, privilege, entitlement, or Program services that the participant receives or is eligible to receive; (7) Services provided for the convenience or preference of the participant or the primary caregiver rather than required by the participant's medical condition; (8) Speech, language, or occupational therapy services rendered in a classroom setting; (9) Shift private duty nursing, CNA, CNA-CMT, HHA, or HHA-CMT services ordered by a physician assistant; (10) Custodial services; (11) Services provided to a participant in a: (a) Hospital; (b) Residential treatment center; (c) Intermediate care facility for individuals with intellectual disabilities; or (d) Residence or facility where nursing services are included in the living arrangement by regulation or statute, or otherwise provided for payment; (12) Services not directly related to the participant’s plan of care; (13) Services described in the plan of care whenever a major change occurs in the participant's medical condition or skilled nursing care needs that indicates such services are no longer necessary; (14) Services which are not initially ordered before the start of care and renewed every 60 days by the participant’s primary medical provider; (15) Services provided by a nurse, CNA, or HHA who does not possess a valid, current, and nontemporary nursing license or certifications to provide services in the jurisdiction in which nursing services are rendered; (16) Services provided by a nurse, CNA, or HHA who does not have a current cardiopulmonary resuscitation (CPR) certification for the period during which the services are rendered; (17) Direct payment for supervisory visits that do not meet acceptable standards of practice in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11; (18) Services rendered to a participant by a nurse, CNA, or HHA in the assigned staff’s home; (19) Services not documented; and (20) Respite services. D. The Program shall only cover one-to-one nursing when a participant’s condition requires that level of service and shared services are not an option. E. The Program shall only cover nursing services ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service. #### Regulation .13 Preauthorization Requirements. *COMAR 10.09.69.13* A. Except for initial assessments unless otherwise specified, preauthorization by the Department or its designee is required for all services under Regulations .10 and .11 of this chapter. B. The Department or its designee shall issue preauthorization when the Department: (1) Determines that services are medically necessary; and (2) Authorizes the services before the initiation or continuance of the requested service. C. Authorization of services shall be rescinded by the Department or its designee when: (1) The participant is admitted to a hospital, residential treatment center, nursing facility, or ICF/IID; (2) The participant is no longer REM eligible; (3) The Department determines the care is no longer medically necessary; or (4) The participant dies. #### Regulation .14 Payment Procedures — Request for Payment. *COMAR 10.09.69.14* A. A provider shall submit a request for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36. B. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36. C. The Department shall pay for covered services at the lower of: (1) The lowest price, including negotiated contract prices, that is offered to any other purchaser for the same or similar service during the same time period, after extending to the Program all rebates, coupons, and negotiated discounts; (2) The actual charge billed by the provider; or (3) Any fee schedule developed for reimbursement of the same service provided under Medical Assistance. D. For dates of service from January 1, 2021, through June 30, 2022, the Department shall pay $445.86 for a case management assessment, as described in Regulation .05C of this chapter. E. For dates of service from January 1, 2021, through June 30, 2022, the Department shall make payments monthly for case management services at one of the rates specified below: (1) Level of Care 1: $329.22; (2) Level of Care 2: $196.22; or (3) Level of Care 3: $103.56. F. Effective July 1, 2022, the Department shall pay $463.69 for a case management assessment, as described in Regulation .05C of this chapter. G. Effective July 1, 2022, the Department shall make payments monthly for case management services at one of the rates specified below: (1) Level of Care 1: $342.39; (2) Level of Care 2: $204.07; or (3) Level of Care 3: $107.70. H. The rates found in §§E and G of this regulation are the monthly rates paid by the Department for a participant receiving case management as follows: (1) Level of Care 1 is intensive level of case management, assessment, and coordination of services for a participant who: (a) Is acutely ill; (b) Has an unstable clinical condition; (c) Has an exacerbated chronic illness; or (d) Has a newly diagnosed condition; (2) Level of Care 2 is case management to a participant who has a history of exacerbations of medical issues requiring services on an ongoing basis to attain stable service or treatment plans; and (3) Level of Care 3 is case management that is required on an ongoing basis to monitor a participant’s stability and treatment plans. #### Regulation .15 Recovery and Reimbursement. *COMAR 10.09.69.15* Recovery and reimbursement under this chapter are set forth in COMAR 10.09.36. #### Regulation .16 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.69.16* Cause for suspension or removal and imposition of sanctions is set forth in COMAR 10.09.36. #### Regulation .17 Table of Rare and Expensive Disease Diagnosis. *COMAR 10.09.69.17* ICD10 ICD 10 Description Age Limit B20 Human immunodeficiency virus (HIV) disease 0—20 C96.0 Multifocal and multisystemic Langerhans-cell histiocytosis 0—64 C96.5 Multifocal and unisystemic Langerhans-cell histiocytosis 0—64 C96.6 Unifocal Langerhans-cell histiocytosis 0—64 D61.01 Constitutional (pure) red blood cell aplasia 0—20 D61.09 Other constitutional aplastic anemia 0—20 D66 Hereditary factor VIII deficiency 0—64 D67 Hereditary factor IX deficiency 0—64 D68.00 Von Willebrand disease, unspecified 0—64 D68.01 Von Willebrand disease, type 1 0—64 D68.020 Von Willebrand disease, type 2A 0—64 D68.021 Von Willebrand disease, type 2B 0—64 D68.022 Von Willebrand disease, type 2M 0—64 D68.023 Von Willebrand disease, type 2N 0—64 D68.029 Von Willebrand disease, type 2, unspecified 0—64 D68.03 Von Willebrand disease, type 3 0—64 D68.04 Acquired von Willebrand disease 0—64 D68.09 Other von Willebrand disease 0—64 D68.1 Hereditary factor XI deficiency 0—64 D68.2 Hereditary deficiency of other clotting factors 0—64 E70.0 Classical phenylketonuria 0—20 E70.1 Other hyperphenylalaninemias 0—20 E70.20 Disorder of tyrosine metabolism, unspecified 0—20 E70.21 Tyrosinemia 0—20 E70.29 Other disorders of tyrosine metabolism 0—20 E70.30 Albinism, unspecified 0—20 E70.40 Disorders of histidine metabolism, unspecified 0—20 E70.41 Histidinemia 0—20 E70.49 Other disorders of histidine metabolism 0—20 E70.5 Disorders of tryptophan metabolism 0—20 E70.81 Aromatic L-amino acid decarboxylase deficiency 0—20 E70.89 Other disorders of amino-acid metabolism 0—20 E71.110 Isovaleric acidemia 0—20 E71.111 3-methylglutaconic aciduria 0—20 E71.118 Other branched-chain organic acidurias 0—20 E71.120 Methylmalonic acidemia 0—20 E71.121 Propionic acidemia 0—20 E71.128 Other disorders of propionate metabolism 0—20 E71.19 Other disorders of branched-chain amino-acid metabolism 0—20 E71.2 Disorder of branched-chain amino-acid metabolism, unspecified 0—20 E71.310 Long chain/very long chain acyl CoA dehydrogenase deficiency 0—64 E71.311 Medium chain acyl CoA dehydrogenase deficiency 0—64 E71.312 Short chain acyl CoA dehydrogenase deficiency 0—64 E71.313 Glutaric aciduria type II 0—64 E71.314 Muscle carnitine palmitoyltransferase deficiency 0—64 E71.318 Other disorders of fatty-acid oxidation 0—64 E71.32 Disorders of ketone metabolism 0—64 E71.39 Other disorders of fatty-acid metabolism 0—64 E71.41 Primary carnitine deficiency 0—64 E71.42 Carnitine deficiency due to inborn errors of metabolism 0—64 E71.50 Peroxisomal disorder, unspecified 0—64 E71.510 Zellweger syndrome 0—64 E71.511 Neonatal adrenoleukodystrophy 0—64 E71.518 Other disorders of peroxisome biogenesis 0—64 E71.520 Childhood cerebral X-linked adrenoleukodystrophy 0—64 E71.521 Adolescent X-linked adrenoleukodystrophy 0—64 E71.522 Adrenomyeloneuropathy 0—64 E71.528 Other X-linked adrenoleukodystrophy 0—64 E71.529 X-linked adrenoleukodystrophy, unspecified type 0—64 E71.53 Other group 2 peroxisomal disorders 0—64 E71.540 Rhizomelic chondrodysplasia punctata 0—64 E71.541 Zellweger-like syndrome 0—64 E71.542 Other group 3 peroxisomal disorders 0—64 E71.548 Other peroxisomal disorders 0—64 E72.01 Cystinuria 0—20 E72.02 Hartnup’s disease 0—20 E72.03 Lowe’s syndrome 0—20 E72.04 Cystinosis 0—20 E72.09 Other disorders of amino-acid transport 0—20 E72.11 Homocystinuria 0—20 E72.12 Methylenetetrahydrofolate reductase deficiency 0—20 E72.19 Other disorders of sulfur-bearing amino-acid metabolism 0—20 E72.20 Disorder of urea cycle metabolism, unspecified 0—20 E72.21 Argininemia 0—20 E72.22 Arginosuccinic aciduria 0—20 E72.23 Citrullinemia 0—20 E72.29 Other disorders of urea cycle metabolism 0—20 E72.3 Disorders of lysine and hydroxylysine metabolism 0—20 E72.4 Disorders of ornithine metabolism 0—20 E72.51 Non-ketotic hyperglycinemia 0—20 E72.52 Trimethylaminuria 0—20 E72.53 Primary hyperoxaluria 0—20 E72.59 Other disorders of glycine metabolism 0—20 E72.81 Disorders of gamma aminobutyric acid metabolism 0—20 E72.89 Other specified disorders of amino-acid metabolism 0—20 E74.00 Glycogen storage disease, unspecified 0—20 E74.01 von Gierke disease 0—20 E74.02 Pompe disease 0—20 E74.03 Cori disease 0—20 E74.04 McArdle disease 0—20 E74.09 Other glycogen storage disease 0—20 E74.12 Hereditary fructose intolerance 0—20 E74.19 Other disorders of fructose metabolism 0—20 E74.21 Galactosemia 0—20 E74.29 Other disorders of galactose metabolism 0—20 E74.4 Disorders of pyruvate metabolism and gluconeogenesis 0—20 E75.00 GM2 gangliosidosis, unspecified 0—20 E75.01 Sandhoff disease 0—20 E75.02 Tay-Sachs disease 0—20 E75.09 Other GM2 gangliosidosis 0—20 E75.10 Unspecified gangliosidosis 0—20 E75.11 Mucolipidosis IV 0—20 E75.19 Other gangliosidosis 0—20 E75.21 Fabry (-Anderson) disease 0—20 E75.22 Gaucher disease 0—20 E75.23 Krabbe disease 0—20 E75.242 Niemann-Pick disease type C 0—20 E75.243 Niemann-Pick disease type D 0—20 E75.244 Niemann-Pick disease type A/B 0—20 E75.25 Metachromatic leukodystrophy 0—20 E75.26 Sulfatase deficiency 0—20 E75.29 Other sphingolipidosis 0—20 E75.3 Sphingolipidosis, unspecified 0—20 E75.4 Neuronal ceroid lipofuscinosis 0—20 E75.5 Other lipid storage disorders 0—20 E76.01 Hurler’s syndrome 0—64 E76.02 Hurler-Scheie syndrome 0—64 E76.03 Scheie’s syndrome 0—64 E76.1 Mucopolysaccharidosis, type II 0—64 E76.210 Morquio A mucopolysaccharidoses 0—64 E76.211 Morquio B mucopolysaccharidoses 0—64 E76.219 Morquio mucopolysaccharidoses, unspecified 0—64 E76.22 Sanfilippo mucopolysaccharidoses 0—64 E76.29 Other mucopolysaccharidoses 0—64 E76.3 Mucopolysaccharidosis, unspecified 0—64 E76.8 Other disorders of glucosaminoglycan metabolism 0—64 E77.0 Defects in post-translational mod of lysosomal enzymes 0—20 E77.1 Defects in glycoprotein degradation 0—20 E77.8 Other disorders of glycoprotein metabolism 0—20 E79.1 Lesch-Nyhan syndrome 0—64 E79.2 Myoadenylate deaminase deficiency 0—64 E79.8 Other disorders of purine and pyrimidine metabolism 0—64 E79.9 Disorder of purine and pyrimidine metabolism, unspecified 0—64 E80.3 Defects of catalase and peroxidase 0—64 E84.0 Cystic fibrosis with pulmonary manifestations 0—64 E84.11 Meconium ileus in cystic fibrosis 0—64 E84.19 Cystic fibrosis with other intestinal manifestations 0—64 E84.8 Cystic fibrosis with other manifestations 0—64 E84.9 Cystic fibrosis, unspecified 0—64 E88.40 Mitochondrial metabolism disorder, unspecified 0—64 E88.41 MELAS syndrome 0—64 E88.42 MERRF syndrome 0—64 E88.49 Other mitochondrial metabolism disorders 0—64 E88.89 Other specified metabolic disorders 0—64 F84.2 Rett’s syndrome 0—20 G11.0 Congenital nonprogressive ataxia 0—20 G11.10 Early-onset cerebellar ataxia, unspecified 0—20 G11.11 Friedreich ataxia 0—20 G11.19 Other early-onset cerebellar ataxia 0—20 G11.2 Late-onset cerebellar ataxia 0—20 G11.3 Cerebellar ataxia with defective DNA repair 0—20 G11.4 Hereditary spastic paraplegia 0—20 G11.8 Other hereditary ataxias 0—20 G11.9 Hereditary ataxia, unspecified 0—20 G12.0 Infantile spinal muscular atrophy, type I (Werdnig-Hoffman) 0—20 G12.1 Other inherited spinal muscular atrophy 0—20 G12.21 Amyotrophic lateral sclerosis 0—20 G12.22 Progressive bulbar palsy 0—20 G12.29 Other motor neuron disease 0—20 G12.8 Other spinal muscular atrophies and related syndromes 0—20 G12.9 Spinal muscular atrophy, unspecified 0—20 G24.1 Genetic torsion dystonia 0—64 G24.8 Other dystonia 0—64 G25.3 Myoclonus 0—5 G25.9 Extrapyramidal and movement disorder, unspecified 0—20 G31.81 Alpers disease 0—20 G31.82 Leigh’s disease 0—20 G31.9 Degenerative disease of nervous system, unspecified 0—20 G32.81 Cerebellar ataxia in diseases classified elsewhere 0—20 G37.0 Diffuse sclerosis of central nervous system 0—64 G37.5 Concentric sclerosis (Balo) of central nervous system 0—64 G71.00 Muscular dystrophy, unspecified 0—64 G71.01 Duchenne or Becker muscular dystrophy 0—64 G71.02 Facioscapulohumeral muscular dystrophy 0—64 G71.031 Autosomal dominant limb girdle muscular dystrophy 0—64 G71.032 Autosomal recessive limb girdle muscular dystrophy due to calpain-3 dysfunction 0—64 G71.033 Limb girdle muscular dystrophy due to dysferlin dysfunction 0—64 G71.0340 Limb girdle muscular dystrophy due to sarcoglycan dysfunction, unspecified 0—64 G71.0341 Limb girdle muscular dystrophy due to alpha sarcoglycan dysfunction 0—64 G71.0342 Limb girdle muscular dystrophy due to beta sarcoglycan dysfunction 0—64 G71.0349 Limb girdle muscular dystrophy due to other sarcoglycan dysfunction 0—64 G71.035 Limb girdle muscular dystrophy due to anoctamin-5 dysfunction 0—64 G71.038 Other limb girdle muscular dystrophy 0—64 G71.039 Limb girdle muscular dystrophy, unspecified 0—64 G71.09 Other specified muscular dystrophies 0—64 G71.11 Myotonic muscular dystrophy 0—64 G71.20 Congenital myopathy, unspecified 0—64 G71.21 Nemaline myopathy 0—64 G71.220 Centronuclear myopathy 0—64 G71.228 Other centronuclear myopathy 0—64 G71.29 Other congenial myopathy 0—64 G80.0 Spastic quadriplegic cerebral palsy 0—64 G80.1 Spastic diplegic cerebral palsy 0—20 G80.3 Athetoid cerebral palsy 0—64 G82.50 Quadriplegia, unspecified 0—64 G82.51 Quadriplegia, C1-C4 complete 0—64 G82.52 Quadriplegia, C1-C4 incomplete 0—64 G82.53 Quadriplegia, C5-C7 complete 0—64 G82.54 Quadriplegia, C5-C7 incomplete 0—64 G91.0 Communicating hydrocephalus 0—20 G91.1 Obstructive hydrocephalus 0—20 I67.5 Moyamoya disease 0—64 K91.2 Postsurgical malabsorption, not elsewhere classified 0—20 N03.A Chronic nephritic syndrome with C3 glomerulonephritis 0—20 N03.1 Chronic nephritic syndrome with focal and segmental glomerular lesions 0—20 N03.2 Chronic nephritic syndrome w diffuse membranous glomrlneph 0—20 N03.3 Chronic neph syndrome w diffuse mesangial prolif glomrlneph 0—20 N03.4 Chronic neph syndrome w diffuse endocaplry prolif glomrlneph 0—20 N03.5 Chronic nephritic syndrome w diffuse mesangiocap glomrlneph 0—20 N03.6 Chronic nephritic syndrome with dense deposit disease 0—20 N03.7 Chronic nephritic syndrome w diffuse crescentic glomrlneph 0—20 N03.8 Chronic nephritic syndrome with other morphologic changes 0—20 N03.9 Chronic nephritic syndrome with unspecified morphologic changes 0—20 N08 Glomerular disorders in diseases classified elsewhere 0—20 N18.1 Chronic kidney disease, stage 1 0—20 N18.2 Chronic kidney disease, stage 2 (mild) 0—20 N18.30 Chronic kidney disease, stage 3, unspecified 0—20 N18.31 Chronic kidney disease, stage 3a 0—20 N18.32 Chronic kidney disease, stage 3b 0—20 N18.4 Chronic kidney disease, stage 4 (severe) 0—20 N18.5 Chronic kidney disease, stage 5 0—20 N18.6 End stage renal disease 0—20 N18.9 Chronic kidney disease, unspecified 0—20 Q01.9 Encephalocele, unspecified 0—20 Q02 Microcephaly 0—20 Q03.0 Malformations of aqueduct of Sylvius 0—20 Q03.1 Atresia of foramina of Magendie and Luschka 0—20 Q03.8 Other congenital hydrocephalus 0—20 Q03.9 Congenital hydrocephalus, unspecified 0—20 Q04.3 Other reduction deformities of brain 0—20 Q04.5 Megalencephaly 0—20 Q04.6 Congenital cerebral cysts 0—20 Q04.8 Other specified congenital malformations of brain 0—20 Q05.0 Cervical spina bifida with hydrocephalus 0—64 Q05.1 Thoracic spina bifida with hydrocephalus 0—64 Q05.2 Lumbar spina bifida with hydrocephalus 0—64 Q05.3 Sacral spina bifida with hydrocephalus 0—64 Q05.4 Unspecified spina bifida with hydrocephalus 0—64 Q05.5 Cervical spina bifida without hydrocephalus 0—64 Q05.6 Thoracic spina bifida without hydrocephalus 0—64 Q05.7 Lumbar spina bifida without hydrocephalus 0—64 Q05.8 Sacral spina bifida without hydrocephalus 0—64 Q05.9 Spina bifida, unspecified 0—64 Q06.0 Amyelia 0—64 Q06.1 Hypoplasia and dysplasia of spinal cord 0—64 Q06.2 Diastematomyelia 0—64 Q06.3 Other congenital cauda equina malformations 0—64 Q06.4 Hydromyelia 0—64 Q06.8 Other specified congenital malformations of spinal cord 0—64 Q07.01 Arnold-Chiari syndrome with spina bifida 0—64 Q07.02 Arnold-Chiari syndrome with hydrocephalus 0—64 Q07.03 Arnold-Chiari syndrome with spina bifida and hydrocephalus 0—64 Q30.1 Agenesis and underdevelopment of nose, cleft or absent nose only 0—5 Q30.2 Fissured, notched and cleft nose, cleft or absent nose only 0—5 Q31.0 Web of larynx 0—20 Q31.8 Other congenital malformations of larynx, atresia or agenesis of larynx only 0—20 Q32.1 Other congenital malformations of trachea, atresia or agenesis of trachea only 0—20 Q32.4 Other congenital malformations of bronchus, atresia or agenesis of bronchus only 0—20 Q33.0 Congenital cystic lung 0—20 Q33.2 Sequestration of lung 0—20 Q33.3 Agenesis of lung 0—20 Q33.6 Congenital hypoplasia and dysplasia of lung 0—20 Q35.1 Cleft hard palate 0—20 Q35.3 Cleft soft palate 0—20 Q35.5 Cleft hard palate with cleft soft palate 0—20 Q35.9 Cleft palate, unspecified 0—20 Q37.0 Cleft hard palate with bilateral cleft lip 0—20 Q37.1 Cleft hard palate with unilateral cleft lip 0—20 Q37.2 Cleft soft palate with bilateral cleft lip 0—20 Q37.3 Cleft soft palate with unilateral cleft lip 0—20 Q37.4 Cleft hard and soft palate with bilateral cleft lip 0—20 Q37.5 Cleft hard and soft palate with unilateral cleft lip 0—20 Q37.8 Unspecified cleft palate with bilateral cleft lip 0—20 Q37.9 Unspecified cleft palate with unilateral cleft lip 0—20 Q39.0 Atresia of esophagus without fistula 0—3 Q39.1 Atresia of esophagus with tracheo-esophageal fistula 0—3 Q39.2 Congenital tracheo-esophageal fistula without atresia 0—3 Q39.3 Congenital stenosis and stricture of esophagus 0—3 Q39.4 Esophageal web 0—3 Q42.0 Congenital absence, atresia and stenosis of rectum with fistula 0—5 Q42.1 Congen absence, atresia and stenosis of rectum without fistula 0—5 Q42.2 Congenital absence, atresia and stenosis of anus with fistula 0—5 Q42.3 Congenital absence, atresia and stenosis of anus without fistula 0—5 Q42.8 Congenital absence, atresia and stenosis of other parts of large intestine 0—5 Q42.9 Congenital absence, atresia and stenosis of large intestine, part unspecified 0—5 Q43.1 Hirschsprung’s disease 0—15 Q44.2 Atresia of bile ducts 0—20 Q44.3 Congenital stenosis and stricture of bile ducts 0—20 Q44.6 Cystic disease of liver 0—20 Q45.0 Agenesis, aplasia and hypoplasia of pancreas 0—5 Q45.1 Annular pancreas 0—5 Q45.3 Other congenital malformations of pancreas and pancreatic duct 0—5 Q45.8 Other specified congenital malformations of digestive system 0—10 Q60.1 Renal agenesis, bilateral 0—20 Q60.4 Renal hypoplasia, bilateral 0—20 Q60.6 Potter’s syndrome, with bilateral renal agenesis only 0—20 Q61.02 Congenital multiple renal cysts, bilateral only 0—20 Q61.19 Other polycystic kidney, infantile type, bilateral only 0—20 Q61.2 Polycystic kidney, adult type, bilateral only 0—20 Q61.3 Polycystic kidney, unspecified, bilateral only 0—20 Q61.4 Renal dysplasia, bilateral only 0—20 Q61.5 Medullary cystic kidney, bilateral only 0—20 Q61.9 Cystic kidney disease, unspecified, bilateral only 0—20 Q64.10 Exstrophy of urinary bladder, unspecified 0—20 Q64.12 Cloacal extrophy of urinary bladder 0—20 Q64.19 Other exstrophy of urinary bladder 0—20 Q75.0 Craniosynostosis 0—20 Q75.1 Craniofacial dysostosis 0—20 Q75.2 Hypertelorism 0—20 Q75.4 Mandibulofacial dysostosis 0—20 Q75.5 Oculomandibular dysostosis 0—20 Q75.8 Other congenital malformations of skull and face bones 0—20 Q77.4 Achondroplasia 0—1 Q77.6 Chondroectodermal dysplasia 0—1 Q77.8 Other osteochondrodysplasia with defects of growth of tubular bones and spine 0—1 Q78.0 Osteogenesis imperfecta 0—20 Q78.1 Polyostotic fibrous dysplasia 0—1 Q78.2 Osteopetrosis 0—1 Q78.3 Progressive diaphyseal dysplasia 0—1 Q78.4 Enchondromatosis 0—1 Q78.6 Multiple congenital exostoses 0—1 Q78.8 Other specified osteochondrodysplasias 0—1 Q78.9 Osteochondrodysplasia, unspecified 0—1 Q79.0 Congenital diaphragmatic hernia 0—1 Q79.1 Other congenital malformations of diaphragm 0—1 Q79.2 Exomphalos 0—1 Q79.3 Gastroschisis 0—1 Q79.4 Prune belly syndrome 0—1 Q79.59 Other congenital malformations of abdominal wall 0—1 Q89.7 Multiple congenital malformations, not elsewhere classified 0—10 R75 Inconclusive laboratory evidence of HIV 0—12 months Z21 Asymptomatic human immunodeficiency virus infection status 0—20 Z99.11 Dependence on respirator (ventilator) status 1—64 Z99.2 Dependence on renal dialysis 21—64 #### Regulation .18 Appeals Procedures. *COMAR 10.09.69.18* Appeal procedures are as set forth in COMAR 10.01.04 and 10.09.36. ### Chapter 70 — Maryland Medicaid Managed Care Program: Non-Capitated Covered Services *Transferred to COMAR 10.67.08* **Administrative History:** Effective date: **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .02C, D amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .05B amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .06B amended effective October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .06C amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) **Administrative History:** Regulation .07 amended as an emergency provision effective June 15, 2001 (28:13 Md. R. 1214); amended permanently effective September 17, 2001 (28:18 Md. R. 1621) **Administrative History:** Regulation .07C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .07H amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .08A amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .10 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) **Administrative History:** Regulation .10A, C amended effective October 5, 2009 (36:20 Md. R. 1528); October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .10C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .10C amended effective December 25, 2000 (27:25 Md. R. 2281); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .11 repealed effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulations .01—.10 under, Maryland Medicaid Managed Care Program: Specialty Mental Health System, repealed and new Regulations .01—.03 under, Maryland Medicaid Managed Care Program: Non-Capitated Covered Services, adopted effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .02L amended effective May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .02M amended effective May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .02N adopted effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .03 amended effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .03K amended effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .03N, O amended effective August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Regulation .03P adopted effective August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Chapter transferred to COMAR 10.67.08 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 71 — Maryland Medicaid Managed Care Program: MCO Dispute Resolution Procedures *Transferred to COMAR 10.67.09* **Administrative History:** Effective date: **Administrative History:** Regulations .01—.03 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .02A, B amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .02B, C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .02C amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .02C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .02C amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .02-1 adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .03 amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .03-1 adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .03-2 adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .04 adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .04 amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .04B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .05 adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .05 amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .05A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .05A, B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .05F, G adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred to COMAR 10.67.09 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 72 — Maryland Medicaid Managed Care Program: Departmental Dispute Resolution Procedures *Repealed* **Administrative History:** Effective date: **Administrative History:** Regulations .01—.06 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730) **Administrative History:** Regulations .01—.06 adopted effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulations .01, .02, and .03 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .01 amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .01C adopted effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .02A, E amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .02F amended effective April 10, 2006 (33:7 Md. R. 668) **Administrative History:** Regulation .04 amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .04A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .05 amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .05B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .05B amended effective April 10, 2006 (33:7 Md. R. 668) **Administrative History:** Regulation .05C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .06B amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulations .01—.06 repealed effective December 31, 2018 (45:26 Md. R. 1244) ### Chapter 73 — Maryland Medicaid Managed Care Program: Sanctions *Transferred to COMAR 10.67.10* **Administrative History:** Effective date: **Administrative History:** Regulations .01 and .02 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01A amended effective June 30, 2008 (35:13 Md. R. 1180); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .01C repealed effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .01-1 adopted as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); adopted permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .03 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .03C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Chapter transferred to COMAR 10.67.10 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 74 — Maryland Medicaid Managed Care Program: Contribution to Graduate Medical Education Costs *Transferred to COMAR 10.67.11* **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993) **Administrative History:** Regulation .03 amended effective December 25, 2000 (27:25 Md. R. 2281) **Administrative History:** Regulation .08 repealed effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Chapter revised effective December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .02B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Chapter transferred to COMAR 10.67.11 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 75 — Maryland Medicaid Managed Care Program: Corrective Managed Care *Transferred to COMAR 10.67.12* **Administrative History:** Effective date: February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .02A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulations .01—.04 repealed and new Regulations .01—.05 adopted effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .02B amended effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulation .05B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred to COMAR 10.67.12 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 76 — School-Based Health Centers (SBHC) **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 2017 (44:7 Md. R. 355) **Administrative History:** Regulation .01B amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .03A, B amended effective June 14, 2021 (48:12 Md. R. 473); November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .04EF amended effective June 9, 2025 (52:11 Md. R. 533) **Administrative History:** Regulation .05 amended effective November 13, 2023 (50:22 Md. R. 973) **Administrative History:** Regulation .05H—K amended effective June 9, 2025 (52:11 Md. R. 533) **Administrative History:** Regulation .06 amended effective June 14, 2021 (48:12 Md. R. 473) #### Regulation .01 Definitions. *COMAR 10.09.76.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health, the State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (2) “Early and periodic screening, diagnosis and treatment (EPSDT)” means the provision of preventive health care, including medical and dental services under 42 CFR §441.50 et seq., in order to assess growth and development and to detect and treat health problems in Medical Assistance eligible individuals younger than 21 years old. (3) “Federally qualified health center (FQHC)” means an entity that has entered into an agreement with the Centers for Medicare and Medicaid Services (CMS) to meet Medicare requirements under 42 CFR §405.2464 and in accordance with 42 CFR §405.2401(b). (4) “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. (5) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice, dental practice, or both; (c) The most cost efficient that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, family, or provider. (6) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (7) “Participant” means an individual who is certified as eligible for, and who is receiving, Medical Assistance benefits. (8) “Primary care provider (PCP)” means a practitioner who is the primary coordinator of care for the participant, and whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services covering the full range of benefits required by the Maryland Medical Assistance Program. (9) “Primary health services” means a basic level of health care, including diagnostic, treatment, consultative, referral, and preventive health services, generally rendered by: (a) General practitioners; (b) Family practitioners; (c) Internists; (d) Obstetricians; (e) Gynecologists; (f) Pediatricians; (g) Physician assistants; and (h) Nurse practitioners. (10) “Program” means the Maryland Medical Assistance Program. (11) “Provider” means a school-based health center which has been approved by the Department. (12) “School-based health center (SBHC)” means a health center that: (a) Is located on school grounds; (b) Provides on-site primary and preventive health care, referrals, and follow-up services; (c) Could provide on-site dental care or behavioral health care, referrals, and follow-up services; and (d) Has been approved by the Maryland Department of Health. (13) “Specialty behavioral health” means services specified in COMAR 10.09.59.06 and 10.09.80.05. #### Regulation .02 License Requirements. *COMAR 10.09.76.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. A physician, nurse practitioner, or physician assistant providing services in an SBHC shall be licensed and legally authorized to practice in the state in which the service is provided. C. A dentist or dental hygienist providing services in an SBHC shall be licensed and legally authorized to practice in the state in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.76.03* A. General requirements for participation in the Program are that a provider shall: (1) Meet the conditions for participation as set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. To participate as a Maryland Medicaid SBHC, a provider shall: (1) Be approved by the Maryland Department of Health as an SBHC; (2) Meet conditions for participation as a: (a) Free-standing clinic as set forth in COMAR 10.09.08.03B; (b) Physician as set forth in COMAR 10.09.02.03; or (c) Nurse practitioner as set forth in COMAR 10.09.01.03. (3) Provide somatic health care services through health professionals who: (a) Are trained and experienced in community health and providing health care services to school-aged children; (b) Have knowledge of health promotion and illness prevention strategies for children and adolescents; and (c) Are EPSDT certified; (4) Ensure staff is assigned responsibilities consistent with the staff's education and experience and within the staff's scope of practice; (5) Designate an individual to be responsible for overall management of the SBHC; (6) Whenever comprehensive primary health services are being delivered, maintain a staffing pattern that includes at least one of the following on-site: (a) A physician; (b) A nurse practitioner; or (c) A physician assistant; (7) Maintain policies and procedures that ensure confidentiality of services and records which are practiced consistently, in accordance with Health-General Article, §4-301, Annotated Code of Maryland; (8) Maintain data collection and storage capabilities adequate to maintain medical records and standard demographic data; (9) Require any physician assistant employed by the provider to have a delegation agreement with the supervising physician in accordance with COMAR 10.09.55.02 and .03; and (10) Transmit a health visit report: (a) To the student's MCO and PCP within 3 business days of the health visit, as designated by the Department, for inclusion in the student-participant's medical record; and (b) If follow-up care with the PCP within 1 week of the health visit is required and the health visit report is mailed, to the student's MCO and PCP by telephone, email, or fax on the day of the SBHC visit. C. Specific requirements for participation in the Program as a dentist or dental hygienist in an SBHC are that a provider shall meet the conditions for participation as set forth in COMAR 10.09.05.03AE. #### Regulation .04 Covered Services. *COMAR 10.09.76.04* An SBHC, designated by the Department as meeting the criteria specified in Regulation .03 of this chapter, is eligible for reimbursement by the Program for the following services: A. Comprehensive well-child care, including the administration of vaccines in accordance with the Maryland Healthy Kids Preventive Health Schedule, when: (1) Performed by EPSDT certified providers; and (2) Rendered according to EPSDT standards set forth in COMAR 10.09.23.03; B. Follow-up of positive or abnormal EPSDT screening components without approval of the PCP, except when referral for specialty care is indicated; C. Comprehensive preventive and primary health services; D. Family planning services as described in COMAR 10.09.58.05; E. Covered dental services in accordance with COMAR 10.09.05; F. Specialty behavioral health services in accordance with COMAR 10.09.59 and 10.09.80; and G. Routine sports physicals. #### Regulation .05 Limitations. *COMAR 10.09.76.05* The Program does not cover the following: A. Services not specified in Regulation .04 of this chapter; B. Services not medically necessary; C. Investigational and experimental drugs and procedures; D. Basic school health services as defined in COMAR 13A.05.05.05.15; E. Nursing or other health services provided as part of a participant's individualized educational program (IEP) as defined in COMAR 10.09.50.01B or individualized family service plan (IFSP) as defined in COMAR 10.09.50.01B; F. Skilled nursing services provided to enable a participant to be safely maintained in the school setting such as: (1) Nasogastric tube feedings; (2) Catheterization; (3) Oral, nasotracheal, or tracheal suctioning; and (4) Nebulizer treatments; G. School health services which are required in all school settings such as: (1) Hearing and vision screening unless completed as part of an EPSDT well-child check-up; (2) Routine assessment of minor injuries; (3) First aid; (4) Administration of medications including supervision of self-administered medications; (5) General health promotion counseling; and (6) Review of health records; H. Vaccines supplied by Vaccines for Children (VFC); I. Visits for the sole purpose of: (1) Administering medication; (2) Checking blood pressure; (3) Measuring weight; (4) Interpreting lab results; or (5) Group or individual health education; and J. Services provided outside of the physical location of the approved SBHC, unless services are rendered via telehealth in accordance with COMAR 10.09.49 and any subregulatory guidance issued by the Department. #### Regulation .06 Reimbursement Methodology. *COMAR 10.09.76.06* A. The provider shall charge the Program the provider’s customary charge to the general public for similar services and charge the provider’s acquisition cost for injectable drugs or dispensed medical supplies. B. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §B of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. C. Local health department clinics, general clinics, physicians, and nurse practitioners shall be paid the lesser of: (1) The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The maximum rates according to COMAR 10.09.02.07. D. The Department shall reimburse an SBHC, sponsored by an LHD or general clinic, for dental services in accordance with COMAR 10.09.05.07. E. The Department shall reimburse an SBHC, sponsored by an LHD, general clinic, nurse practitioner, or physician, for specialty behavioral health services in accordance with COMAR 10.21.25 and 10.09.80.08. F. The Department shall reimburse an SBHC, sponsored by an FQHC, for services in accordance with COMAR 10.09.08.08. #### Regulation .07 Payment Procedures. *COMAR 10.09.76.07* A. The provider shall submit a completed request for payment in the format designated by the Department or HealthChoice MCO, including required documentation. B. The dental provider shall submit a request for payment in the format designated by the Department and in accordance with COMAR 10.09.05.07. C. The Program reserves the right to return to the provider, before payment, all invoices not properly completed. D. Unless the service is free to individuals not covered by Medicaid, a provider shall bill the Program the provider’s customary charge to the general public for similar services. E. The Department shall authorize payment on Medicare cross-over claims only if: (1) The provider accepts Medicare assignments; (2) Medicare makes a direct payment to the provider; (3) Medicare determines the services are medically necessary; (4) The services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. F. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: (1) A deductible shall be paid in full; (2) Coinsurance shall be paid at the lesser of: (a) 100 percent of the coinsurance amount; or (b) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; (3) Services not covered by Medicare, but considered medically necessary by the Program, shall be paid according to the limitations of this chapter; and (4) Coinsurance shall be paid in full to FQHC providers. G. An SBHC providing self–referred services as described in COMAR 10.67.06.28 to an MCO participant shall: (1) Verify eligibility and MCO assignment through EVS on the day of service; (2) Submit claims within 180 days of performing the service; (3) Submit claims using the CMS 1500 for paper processing and the HIPAA compliant 837P for electronic processing; and (4) Bill third party insurers before billing the MCO with the exception of well-child care and immunizations. H. The provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) More than one visit to complete an EPSDT screen; and (4) Providing a copy of a participant’s medical record when requested by another licensed provider on behalf of the participant. I. The Program may not make direct payment to participants. J. The Program may not make a separate direct payment to any individual employed by or under contract to any SBHC for services provided in an SBHC. K. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.76.08* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.76.09* Cause for suspension or removal and imposition of sanctions are as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.76.10* Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09. #### Regulation .11 Interpretive Regulation. *COMAR 10.09.76.11* State regulations shall be interpreted in conformity with COMAR 10.09.36.10. ### Chapter 77 — Urgent Care Centers **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 21, 2008 (35:8 Md. R. 805) **Administrative History:** Regulation .01B amended effective July 10. 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .03 amended effective July 10. 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .04 amended effective July 10. 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .04D amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .05D amended effective July 10. 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .05F amended effective March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .06A amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .06A, C, H amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .06C amended effective June 14, 2021 (48:12 Md. R. 473) **Administrative History:** Regulation .06G amended effective April 4, 2011 (38:7 Md. R. 430) **Administrative History:** Regulation .06I amended effective July 10. 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .07A amended effective July 10. 2023 (50:13 Md. R. 512) **Administrative History:** Regulation .09 amended effective January 24, 2011 (38:2 Md. R. 84) **Administrative History:** Regulation .10 amended effective July 10. 2023 (50:13 Md. R. 512) #### Regulation .01 Definitions. *COMAR 10.09.77.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health, the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (2) “Free-standing clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services. (3) “Free-standing urgent care center” means a location, distinct from a hospital emergency room, a physician's office, or a free-standing clinic, whose purpose is to diagnose and treat illness or injury for unscheduled, ambulatory patients seeking immediate medical attention. (4) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01. (5) “Medical Assistance Program” means a program of comprehensive medical and other health-related care for indigent and medically indigent persons. (6) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (7) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, U.S.C. §1395 et seq. (8) “Participant” means an individual who is certified as eligible for and is receiving Medical Assistance benefits. (9) “Patient” means a participant awaiting or undergoing health care or treatment. (10) “Physician” means an individual legally licensed to practice medicine in the state in which the physician's practice is located. (11) “Program” means the Maryland Medical Assistance Program. (12) “Provider” means a free-standing urgent care center which, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of a Medical Assistance provider number. (13) “Urgent care” means the delivery of ambulatory care, such as for acute illnesses or minor traumas, in a facility dedicated to the delivery of unscheduled, walk-in care outside of a hospital emergency department, a free-standing clinic, or a physician's office. #### Regulation .02 License Requirements. *COMAR 10.09.77.02* A. License requirements under this chapter are found in COMAR 10.09.36.02. B. The provider shall ensure that all X-ray and other radiological equipment is maintained and inspected in compliance with the requirements of Environment Article, Title 8, Subtitle 3, Annotated Code of Maryland. C. Urgent care services may be performed only by health care practitioners who are licensed to perform these procedures within the state in which the center is located. D. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with the requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.09.09.02 and 10.10.01.02, as applicable; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.77.03* A. The general requirements for participation in the Program are that a provider shall: (1) Meet all the conditions for participation as set forth in COMAR 10.09.36; and (2) If delivering services via telehealth, comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. B. The specific requirements for participation in the Program as a free-standing urgent care center include the following: (1) Have clearly defined, written, patient care policies; (2) Define the center's hours of operation and clearly communicate those hours of operation to the public and other relevant organizations; (3) Ensure that patients seeking urgent care are seen without prior appointments; (4) During the hours of operation, have: (a) A supervising physician, available for consultation either in-person or via telehealth; and (b) At least one qualified physician, certified nurse practitioner, or physician assistant present; (5) Maintain adequate documentation of each participant visit as part of the individual’s medical record, which, at a minimum, shall include: (a) Date of service; (b) Participant’s reason for visit; (c) A brief description of service provided; and (d) A legible signature and printed or typed name of the professional providing care, with the appropriate title; (6) Have written, effective procedures for infection control which are known to all levels of staff as specified in COMAR 10.06.01; and (7) Have laboratory testing and radiology services available to meet the needs of the patients receiving urgent care. #### Regulation .04 Covered Services. *COMAR 10.09.77.04* The Program covers the following medically necessary services rendered to participants in a free-standing urgent care center: A. Acute illnesses with a sudden onset; B. Minor trauma; C. Diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative services, when clearly related to the participant’s individual needs; D. Urgent care services, when the services are performed by a physician or one of the following acting within the scope of their practice: (1) A licensed physician assistant; (2) A licensed registered nurse; or (3) A certified nurse practitioner; and E. Laboratory services as governed by Regulation .02 of this chapter. #### Regulation .05 Limitations. *COMAR 10.09.77.05* The Program does not cover the following: A. Services not medically necessary; B. Investigational and experimental drugs and procedures; C. Services denied by Medicare as not medically necessary; D. Services rendered via telehealth that do not comply with the telehealth requirements established in COMAR 10.09.49 and any other subregulatory guidance issued by the Department; E. Laboratory or x-ray services performed by another facility; F. Immunizations, except for: (1) Tetanus; and (2) Rabies; G. Visits only to accomplish one or more of the following: (1) Collection of specimens for laboratory procedures; (2) Interpretation of laboratory tests or panels; (3) Ascertaining the patient's weight; and (4) Measurement of blood pressure; H. Well child visits; and I. Sports physicals #### Regulation .06 Payment Procedures. *COMAR 10.09.77.06* A. Payment for free-standing urgent care centers is as follows: (1) Urgent care centers are reimbursed a facility fee, which is determined by the Program; (2) In addition to the facility fee, the Program shall reimburse for services rendered by the physician, nurse practitioner, or physician assistant during the visit at the free-standing urgent care center; and (3) If the service is free to individuals not covered by Medicaid: (a) The provider: (i) May charge the Program; and (ii) Shall be reimbursed in accordance with the provisions of this regulation; and (b) The provider's reimbursement is not limited to the provider's customary charge. B. Reimbursement by the Program for facility services, which are included in the facility fee, includes: (1) Nursing, technician, and related services; (2) Use of the center; (3) Drugs, biologicals, surgical dressings, supplies, splints, casts, and appliances, and any equipment directly related to the treatment of the illness or injury; and (4) Administrative costs. C. The Department shall pay for covered services at the lesser of: (1) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) The Department's fee for: (a) Professional services in accordance with COMAR 10.09.02.07D; and (b) Laboratory services in accordance with COMAR 10.09.09.07D. D. The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. E. The Program reserves the right to return to the provider, before payment, all invoices that are not properly completed. F. The Program shall authorize payment on Medicare claims only if: (1) The provider accepts Medicare assignment; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that the services are medically necessary; (4) Services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. G. The Department shall make supplemental payment on Medicare claims subject to the limitations of the State budget and the following provisions: (1) Deductible insurance shall be paid in full; (2) Beginning with August 1, 2010 dates of service, coinsurance shall be paid: (a) In full for the following: (i) Mental health services; (ii) CPT codes that are priced by report; (iii) Claims for anesthesia services; (iv) Claims from a federally qualified health center; and (v) HCPCS codes beginning with A through W; and (b) For all other claims, at the lesser of: (i) 100 percent of the coinsurance amount; or (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and (3) Services not covered by Medicare, but considered medically necessary by the Program, will be paid according to the limitations of Regulation .04 of this chapter. H. The provider may not bill the Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; or (3) Professional services rendered by mail or telephone. I. The Program may not make a direct payment to a participant. J. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.77.07* A. If the participant has insurance, or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the participant for, services covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Program, the provider may submit a claim to the Program. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. If payment is made by both the Program and the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program or the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.77.08* Causes for suspension or removal and imposition of sanctions under this chapter are set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.77.09* Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.77.10* Except when the language of a specific regulation indicates intent by the Department to provide reimbursement for covered services to Program participants without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ### Chapter 78 — Home Visiting Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: January 13, 2022 (49:1 Md. R. 13) #### Regulation .01 Definitions. *COMAR 10.09.78.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §§1396 et seq. (2) “Evidence-based home visiting model” means a voluntary early childhood strategy program that includes focused, individualized, and culturally competent services for expectant parents, young children, and their families designed to enhance parenting and promote the growth and development of young children. (3) “Home” means the program participant’s place of service in a community setting defined by the evidence-based home visiting models. (4) “Home visiting program” means the organization or entity accredited by an evidence-based home visiting model to provide home visiting services under that model. (5) “Home visiting services” means services provided during the prenatal and postpartum periods in the program participant’s home by the home visiting program, including but not limited to: (a) Pregnancy education; (b) Child development education; (c) Diet and nutritional education; (d) Stress management; (e) Sexually transmitted diseases (STD) prevention education; (f) Tobacco use screening and cessation education; (g) Alcohol and other substance misuse screening and counseling; (h) Depression screening; (i) Postpartum depression education; (j) Domestic and intimate partner violence screening and education; (k) Breastfeeding support and education; (l) Guidance and education with regard to well woman visits to obtain recommended preventive services; (m) Maternal-infant safety assessment and education; (n) Counseling regarding postpartum recovery, family planning, and needs of a newborn; (o) Assistance for the family in establishing a primary source of care and a primary care provider; (p) Parenting skills, parent-child relationship building, and confidence building; (q) Child developmental screening at major developmental milestones from birth to two years old; (r) Facilitation of access to community or other resources that can improve birth-related outcomes such as: (i) Transportation; (ii) Housing; (iii) Alcohol, tobacco, and drug cessation; and (iv) WIC, SNAP, and intimate partner violence resources; (s) Monitoring for high blood pressure or other complications of pregnancy; and (t) Medical assessment of the postpartum mother and infant. (6) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (7) “Postpartum period” means the period that begins immediately after childbirth up to a period of time following childbirth as defined by the evidence-based home visiting model. (8) “Prenatal period” means the developmental period between conception and birth. (9) “Program” means the Maryland Medical Assistance Program. (10) “Program participant” means one of the following individuals enrolled in the evidence-based home visiting model: (a) Birthing parent; (b) Infant; (c) Child up to the age permitted under the evidence-based home visiting model; or (d) Other individuals, as recognized under the evidence-based home visiting model. (11) “Provider” means a qualified individual licensed or certified to deliver home visiting services as a part of an evidence-based home visiting model. #### Regulation .02 Certification Requirements. *COMAR 10.09.78.02* The home visiting program provider shall have an active accreditation status from one of the following evidence-based home visiting models: A. Healthy Families America (HFA); or B. Nurse Family Partnership (NFP). #### Regulation .03 Conditions for Participation. *COMAR 10.09.78.03* A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03; and B. Specific requirements for participation in the home visiting program are that the provider shall provide proof of accreditation by one of the following evidence-based home visiting models: (1) Healthy Families America (HFA); or (2) Nurse Family Partnership (NFP). #### Regulation .04 Covered Services. *COMAR 10.09.78.04* The Program covers home visiting services rendered in the program participant’s home when the services: A. Are rendered during the birthing parent’s prenatal period and postpartum periods; and B. If not rendered in person, comply with the telehealth requirements established in COMAR 10.09.49 and any subregulatory guidance issued by the Department. #### Regulation .05 Limitations. *COMAR 10.09.78.05* The Program does not cover: A. Expenses including: (1) Administrative overhead; (2) Lactation consulting services; and (3) Program start-up costs for evidence-based model accreditation, initial training, or consultation; or B. Services that are not medically necessary. #### Regulation .06 Payment Procedures. *COMAR 10.09.78.06* A. The provider shall submit the request for payment in the format designated by the Department. B. The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program. C. The provider shall charge the Program the provider’s customary charge to the general public for similar services. D. The Program will reimburse a provider for covered services: (1) The lesser of the provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (2) In accordance with §I of this regulation. E. If the service is free to individuals not covered by Medicaid: (1) The provider: (a) May charge the Program; and (b) Shall be reimbursed in accordance with §I of this regulation; and (2) The provider’s reimbursement is not limited to the provider’s customary charge. F. The provider may not bill the Program or the participant for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail; or (4) Providing a copy of a program participant’s medical record when requested by another provider on behalf of the participant. G. Payments for services rendered to a Program participant shall be made directly to a qualified provider. H. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. I. Effective January 1, 2022, the Program shall reimburse a flat rate of $188 per home visit. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.78.07* Recovery and reimbursement regulations are set forth in COMAR 10.09.36.07. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.78.08* Cause for suspension or removal and imposition of sanctions are set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.78.09* Providers filing appeals from administrative decisions made in connection with this chapter shall do so according to COMAR 10.09.36.09 ### Chapter 79 — Presumptive Eligibility for Correctional Facilities **Authority:** Health-General Article, §15-103(b), Annotated Code of Maryland **Administrative History:** Effective date: December 18, 2017 (44:25 Md. R. 1180) **Administrative History:** Regulation .02B amended effective December 30, 2019 (46:26 Md. R. 1164); March 30, 2026 (53:6 Md. R. 291) **Administrative History:** Regulation .03 amended effective December 30, 2019 (46:26 Md. R. 1164) #### Regulation .01 Purpose and Scope. *COMAR 10.09.79.01* This chapter establishes requirements for qualified State and local corrections facilities to make presumptive eligibility determinations effective July 1, 2017. #### Regulation .02 Definitions. *COMAR 10.09.79.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual who has applied for presumptive eligibility at a participating qualified correctional facility. (2) “Application” means the presumptive eligibility application. (3) “Correctional facility” has the meaning stated in Correctional Services Article, §1-101, Annotated Code of Maryland, and includes: (a) Correctional facilities under the direction of the Department of Public Safety and Correctional Services; and (b) Local correctional facilities within the State’s 24 local jurisdictions. (4) “Department” means the Department of Health, which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Determination” means a decision regarding an applicant’s presumptive eligibility. (6) “Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2). (7) “Former foster care” means an individual who: (a) Is younger than 26 years old; (b) Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and (c) Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance: (i) On attaining age 18 and leaving out-of-home placement; or (ii) On attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B. (8) “Incarcerated inmate” means an individual who resides in a public institution involuntarily as a result of being accused or found guilty of a criminal offense, including the duration of time in which the individual is involuntarily residing in the public institution in a preadjudication or pretrial status. (9) “Income” means property or a service received by an individual in cash or in-kind that can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. (10) “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals. (11) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq. (12) “Memorandum of understanding” means the agreement by which the correctional facility has contracted with the Department and been deemed a qualified entity eligible to make presumptive eligibility decisions. (13) “Presumptive eligibility” means temporary eligibility for Medical Assistance as determined by an eligibility worker at a participating qualified correctional facility in accordance with this chapter. #### Regulation .03 Requirements. *COMAR 10.09.79.03* A. A correctional facility based in Maryland is eligible to participate as a presumptive eligibility entity. B. The eligibility worker shall: (1) Using the Department’s eligibility verification system, verify the individual is not actively enrolled in the Maryland Medical Assistance Program; and (2) Complete the full Medical Assistance application process; C. Unless the individual is enrolled in the Maryland Medical Assistance Program, the eligibility worker shall: (1) Fill out the presumptive eligibility application based on information supplied by the applicant; (2) Make a presumptive eligibility determination based on the following information: (a) Residency; (b) Citizenship; (c) Family size and composition; and (d) Gross family income; (3) Sign the application; and (4) Inform the applicant in writing of the presumptive eligibility determination, which includes an explanation of the presumptive eligibility coverage span. D. In order to ensure the applicant has temporary Medical Assistance coverage, the eligibility worker shall submit the presumptive eligibility application to the Department on the date the application is completed. E. After the application has been submitted, the correctional facility shall: (1) Keep all written and signed presumptive eligibility applications on file for 6 years; and (2) Make the file available to the Department on request. F. On finding that a qualified correctional facility has failed to meet the requirements of §§A—E of this regulation, the facility shall take reasonable corrective action measures, as determined by the Department, to address the noncompliance. #### Regulation .04 Presumptive Eligibility Criteria. *COMAR 10.09.79.04* A. An individual shall apply for presumptive eligibility through a participating correctional facility. B. An individual who applies for presumptive eligibility shall attest to: (1) The citizenship requirements in COMAR 10.09.24.05; (2) The residency requirements in COMAR 10.09.24.05-3; (3) The individual’s pregnancy status; (4) The individual’s family size; and (5) The individual’s household’s gross monthly income. #### Regulation .05 Eligible Populations. *COMAR 10.09.79.05* If an incarcerated inmate in a Maryland-based correctional facility is determined to be eligible for one of the following coverage groups, the individual may qualify for presumptive eligibility for correctional facilities: A. Parents and other caretaker relatives whose household income is equal to or less than 133 percent of the federal poverty level; B. Pregnant women whose income is equal to or less than 250 percent of the federal poverty level; C. Childless adults 19 years old or older and younger than 65 years old whose household income is equal to or less than 133 percent of the federal poverty level; and D. Former foster care individuals who are younger than 26 years old. #### Regulation .06 Limitations. *COMAR 10.09.79.06* Presumptive eligibility may not be granted to an individual who: A. Is currently enrolled in the Maryland Medical Assistance Program or Medicare; B. With the exception of pregnant women, had a prior presumptive eligibility period during the last 12 months; C. Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or D. Does not meet the citizenship requirements stated in COMAR 10.09.24.05. #### Regulation .07 Coverage Span. *COMAR 10.09.79.07* A. Presumptive eligibility begins on the day the presumptive eligibility worker determines the individual is presumptively eligible. B. Presumptive eligibility ends on the earlier of: (1) The day the individual is determined eligible for Medical Assistance; or (2) The last day of the month following the month in which the correctional facility determined presumptive eligibility, if an individual: (a) Is found ineligible for Medical Assistance; or (b) Failed to apply for Medical Assistance. C. A non-pregnant individual may be determined presumptively eligible once per a 12-month period. D. A pregnant individual may be determined presumptively eligible once per pregnancy. #### Regulation .08 Presumptive Eligibility Appeal Rights. *COMAR 10.09.79.08* An individual or an organization does not have appeal rights for presumptive eligibility determinations. ### Chapter 80 — Community-Based Substance Use Disorder Services **Authority:** Health-General Article, §§2-104(b), 7.5-204, 7.5-205(d), 7.5-402, 8-204(c)(1),15-103(a)(1), and 15-105(b), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.09 adopted as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); adopted permanently effective May 31, 2010 (37:11 Md. R. 765) **Administrative History:** Chapter revised effective December 22, 2014 (41:25 Md. R. 1480) **Administrative History:** Regulation .01B amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1302); September 25, 2017 (44:19 Md. R. 897) **Administrative History:** Regulation .03 amended effective October 26, 2015 (42:21 Md. R. 1302); November 14, 2022 (49:23 Md. R. 996) **Administrative History:** Regulation .03A, B amended effective September 25, 2017 (44:19 Md. R. 897) **Administrative History:** Regulation .04 amended effective October 26, 2015 (42:21 Md. R. 1302) **Administrative History:** Regulation .05 amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); September 25, 2017 (44:19 Md. R. 897); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation .06 amended effective October 26, 2015 (42:21 Md. R. 1302); April 10, 2017 (44:7 Md. R. 356); May 15, 2023 (50:9 Md. R. 379) **Administrative History:** Regulation .06A, B amended effective November 14, 2022 (49:23 Md. R. 996) **Administrative History:** Regulation .07C amended effective October 26, 2015 (42:21 Md. R. 1302) **Administrative History:** Regulation .08 amended effective October 26, 2015 (42:21 Md. R. 1302); November 14, 2022 (49:23 Md. R. 996); May 15, 2023 (50:9 Md. R. 379); November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .08D amended effective October 24, 2016 (43:21 Md. R. 1166); April 10, 2017 (44:7 Md. R. 356); January 1, 2018 (44:26 Md. R. 1215); December 30, 2019 (46:26 Md. R. 1164) **Administrative History:** Regulation .08D – F amended August 5, 2024 (51:15 Md. R. 708) #### Regulation .01 Definitions. *COMAR 10.09.80.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative Service Organization (ASO)” means the contractor procured by the State to provide the Department with administrative support services to operate the Maryland Public Behavioral Health System. (2) “Behavioral Health Administration (BHA)” means the administration within the Department that establishes regulatory requirements that behavioral health programs are to maintain in order to become licensed by the Department. (3) “Community-based substance use disorder program” means a program that provides services in community settings not regulated by the Health Services Cost Review Commission. (4) “DATA 2000 waived provider” means a provider who has received a waiver under the Drug Addiction and Treatment Act of 2000 which expands the clinical context of medication assisted opioid dependency treatment and permits qualified physicians, nurse practitioners, and physician assistants to dispense or prescribe certain narcotic medications that have a lower risk of abuse, like buprenorphine, in settings other than an opioid treatment program. (5) “DEA” means the Drug Enforcement Administration of the U.S. Department of Justice. (6) “Department” means the Maryland Department of Health, as defined in COMAR 10.09.36.01, or its authorized agents acting on behalf of the Department. (7) “Discharge plan” means a written description of specific goals and objectives to assist the participant upon leaving treatment. (8) “Documentation” means the written medical record. (9) “Individualized treatment plan” means a written plan of action that is developed and periodically updated and revised to address a participant’s specific service needs. (10) “License” means the approval issued to a program by the BHA or its designee that permits a behavioral health provider to operate in Maryland. (11) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. (12) “Medically necessary” has the meaning stated in COMAR 10.09.36.01. (13) “Medication management” means a visit with a physician, nurse practitioner, or physician assistant for the purpose of evaluation, prescribing, and providing medications for substance use disorder symptom reduction, withdrawal management, or medication assisted treatment. (14) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (15) “Peer recovery support services” means a set of nonclinical activities provided by individuals in recovery from behavioral health concerns, including substance use or addictive disorders or mental health concerns, who use their personal, lived experiences and training to support other individuals with substance use or addictive disorders. (16) “Program” has the meaning stated in COMAR 10.09.36.01. (17) “Progress note” means an objective documentation of the participant’s progress in relation to specific treatment goals and objectives. (18) “Recovery support services” means community-based services provided to people and their families during the initiation, on-going, and post-acute stages of their recovery from substance abuse. (19) “Substance use disorder” means a maladaptive pattern of substance use leading to clinically significant impairment or distress and manifested by recurrent and significant adverse consequences related to the repeated use of substances. (20) “Substance use disorder services” means the services for which a participant’s diagnosis and treatment provider meet the criteria specified in COMAR 10.67.08 and this chapter. (21) “Telehealth” has the meaning stated in COMAR 10.09.49.02. (22) “Treatment plan” means a written plan that addresses the individual’s biopsychosocial needs through goals and objectives and is updated as needed according to the treatment modality. #### Regulation .02 License Requirements. *COMAR 10.09.80.02* To participate in the Program, a provider shall meet the license requirements stated in COMAR 10.09.36.02 and 10.63.01.03. #### Regulation .03 Conditions for Provider Participation. *COMAR 10.09.80.03* A. A provider shall be in compliance with COMAR 10.09.36.03 and 10.63.01.05. B. A provider of community-based substance use disorder services shall include: (1) Community-based substance use disorder providers that: (a) Are licensed by the Department as community-based substance use disorder providers pursuant to the requirements listed in Regulation .05 of this chapter; (b) Maintain verification of licenses and credentials of all professionals employed by or under contract with the provider in their respective personnel files; and (c) Require any physician assistant employed by the provider to have a delegation agreement with the supervising physician in accordance with COMAR 10.09.55.02 and .03; (2) Federally qualified health centers in compliance with COMAR 10.09.08; or (3) Opioid treatment programs that: (a) Are licensed by the Department’s Behavioral Health Administration; (b) Are approved by the U.S. Drug Enforcement Administration; and (c) Comply with 42 CFR Part 8. C. A provider of substance use disorder services shall maintain adequate documentation of each contact with a participant as part of the medical record, which, at a minimum, includes: (1) The date of service with start and end times; (2) Documents all services received by the participant; (3) The participant’s primary reason for the substance use disorder visit; (4) A description of the service provided; (5) Progress notes; and (6) An official e-Signature, or a legible signature, along with the printed or typed name of the individual providing care, with the appropriate degree or title. D. The providers shall make the documentation required under Regulation .05C available, as requested to carry out required activities, to: (1) The Department; (2) The ASO; (3) The Core Service Agency; (4) The Local Addictions Authority; (5) The Local Behavioral Health Authority; (6) The Office of Inspector General of the Department; and (7) The Office of the Attorney General Medicaid Fraud Control Unit. E. A provider shall comply with all federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164. F. If delivering services via telehealth, a provider shall comply with COMAR 10.09.49 and any subregulatory guidance issued by the Department. #### Regulation .04 Participant Eligibility and Referral. *COMAR 10.09.80.04* A. A participant may self-refer or be referred to substance use disorder treatment by a: (1) Provider; (2) Family member; (3) Caregiver; or (4) Local health authority. B. An individual is eligible for substance use disorder services if: (1) The individual meets the Department’s medical necessity criteria; and (2) The service is appropriate to the specific provider type or community-based substance use disorder providers listed in Regulation .05 of this chapter. #### Regulation .05 Covered Services. *COMAR 10.09.80.05* A. Comprehensive substance use disorder assessment at a minimum shall: (1) Be delivered through: (a) A BHA licensed substance use disorder treatment provider; or (b) An opioid treatment program; (2) Be completed before providing the community based behavioral health services listed in §§BI of this regulation; (3) Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and (4) Include: (a) An assessment of the following areas: (i) Drug and alcohol use; and (ii) Substance use disorder treatment history; (b) Referrals for physical and mental health services; and (c) Recommendation for the appropriate level of substance use disorder treatment. B. Peer recovery support services shall: (1) Be included as part of a written individualized treatment plan that includes specific individualized goals; (2) Be delivered through a BHA licensed: (a) Outpatient substance use disorder treatment provider in compliance with COMAR 10.63.03.06, 10.63.03.03 or 10.63.03.07; or (b) Opioid treatment program in compliance with COMAR 10.63.03.19; (3) Be provided by staff who, at a minimum: (a) Maintains active certification by BHA or its designee; (b) Self-identifies as an individual with life experience of being diagnosed with behavioral health concerns, including substance use disorders, addictive disorders, or mental health concerns; (c) Completes ongoing training as approved by BHA or its designee; and (d) Receives supervision by: (i) A registered peer supervisor approved by BHA or its designee; or (ii) An individual practitioner as defined in COMAR 10.09.59.04A(2) or a certified alcohol and drug counselor who is approved to supervise by the relevant board and who must be an approved registered peer supervisor on or after September 1, 2023; and (4) Be provided directly to the participant either in-person or via telehealth. C. Level 1 group and individual substance use disorder counseling shall: (1) Comply with COMAR 10.63.03.06; (2) Be delivered through: (a) A BHA licensed substance use disorder treatment provider; or (b) An opioid treatment program; (3) Include services for participants who require less than 9 hours weekly for adults and 6 hours weekly for adolescents; (4) Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall: (a) Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and (b) Include: (i) Participant treatment plan goals; (ii) Referrals to ancillary services, if needed; and (iii) Referral to recovery support services, if needed; and (5) Include family members, if necessary, as long as the participant is also present in a Level 1 group counseling session. D. Level 2.1 Intensive Outpatient services shall: (1) Comply with COMAR 10.63.03.03; (2) Be delivered through a BHA licensed substance use disorder treatment provider only; (3) Include services for participants who require outpatient treatment for 9 or more hours weekly for an adult and 6 or more hours weekly for an adolescent; (4) Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall: (a) Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and (b) Include: (i) Participant treatment plan goals; and (ii) Specific interventions that reflect the amounts, frequencies and intensities appropriate to the objective of the treatment plan; and (5) Include a discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services. E. Level 2.5 partial hospitalization services shall: (1) Comply with COMAR 10.63.03.07; (2) Be delivered through a BHA licensed substance use disorder treatment provider; (3) Include services for participants who require a minimum of 20 hours weekly of structured outpatient treatment delivered in the following ways: (a) Half day sessions with a minimum of 2 hours per day of services; or (b) Full day sessions with a minimum of 6 hours per day of services; (4) Include a written individualized treatment plan, with the participation of the participant based on the comprehensive assessment that shall: (a) Be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; and (b) Include: (i) Participant treatment plan goals; and (ii) Specific interventions that reflect the amounts, frequencies and intensities appropriate to the objective of the treatment plan; and (5) Include a discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services. F. Ambulatory withdrawal management service shall: (1) Comply with COMAR 10.63.03.18; (2) Be delivered through a BHA licensed substance use disorder treatment provider; (3) Include the following services as medically necessary: (a) Administration and monitoring of medication, including administration and monitoring of psychotropic medication by qualified staff, as necessary; and (b) Managing withdrawal symptoms; and (4) Include a participant progress note added to the participant-s record after each session. G. Buprenorphine and other medication assisted treatment delivered by a BHA licensed substance use disorder treatment provider that employs a practitioner who holds a DEA registration with Schedule III authority in compliance with 21 U.S.C. §823 shall include the following: (1) Services delivered by a DEA registered practitioner with Schedule III authority, including: (a) Pharmacological interventions, including the use of FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants; (b) At a minimum, medical services required to be provided by the Program that: (i) Ensure that participants receive a dose adequate to alleviate withdrawal symptoms; (ii) Employ dose increases and behavior therapy before mandatory detoxification for participants continuing to use drugs; (iii) Establish participant dosing based on an individual need; (iv) Provide flexible dosage tapering and withdrawal management with dosage reductions at the participant’s request; (c) Ordering and administering non-narcotic drugs; and (2) Services provided by alcohol and drug counselors and other staff as appropriate, including: (a) Substance use disorder and related counseling as recommended in the individualized treatment plan; and (b) Point of care presumptive drug testing that shall be: (i) Presumptive in nature and performed at the point of care; and (ii) Capable of being read by direct optical observation only. H. For dates of service before January 1, 2023, BHA licensed substance use disorder treatment providers rendering buprenorphine and other medication assisted treatment are required to comply with requirements for DATA 2000 waived providers. I. Opioid maintenance therapy services delivered through the use of methadone or buprenorphine by opioid treatment programs shall comply with 10.63.03.19 and include: (1) An individualized treatment plan that shall be reviewed and approved by a licensed physician or licensed practitioner of the healing arts, within the scope of his or her practice under State law; (2) The following services: (a) Pharmacological interventions, including the use of FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants; (b) Point of care presumptive drug testing; (c) Definitive drug testing when completed by a laboratory; (d) Substance use disorder and related counseling as recommended in the individualized treatment plan; (e) Periodic medication management; (f) Medical services, including, but not limited to, those required to be provided by the Program that ensure that participants receive a dose adequate to alleviate withdrawal symptoms; and (g) Ordering and administering non-narcotic drugs; (3) A discharge plan, which includes written recommendations to assist the participant with continued recovery efforts, as well as appropriate referral services; and (4) Guest dosing arrangements with other opioid treatment programs, as medically necessary. J. Medication assisted treatment induction service delivered by opioid treatment programs shall include the following services, as medically necessary: (1) Pharmacological interventions, including the use of one of the following FDA-approved opiate agonist and partial agonist treatment medications to provide treatment, support, and recovery to opioid-addicted participants: (a) Buprenorphine; or (b) Methadone; (2) Medical services, including, but not limited to, those required to be provided by the Program that ensure that participants receive a dose adequate to alleviate withdrawal symptoms; and (3) Ordering and administering non-narcotic drugs. #### Regulation .06 Limitations. *COMAR 10.09.80.06* A. The Program under this chapter does not cover the following: (1) Community-based substance use disorder services not specified in Regulation .05 of this chapter; (2) Community-based substance use disorder services not approved by a licensed physician or other licensed practitioner of the healing arts, within the scope of his or her practice under State law; (3) Services not identified by the Department as medically necessary or listed in Regulation .05 of this chapter; (4) Investigational and experimental drugs and procedures; (5) Substance use disorder visits solely for the purpose of: (a) Prescribing medication; (b) Administering medication; (c) Drug or supply pick-up; (d) Collecting laboratory specimens; (e) Interpreting laboratory tests or panels; or (f) Administering injections, unless the following are documented in the participant’s medical record: (i) Medical necessity; and (ii) The participant’s inability to take appropriate oral medications; (6) Services that are provided in a hospital inpatient or outpatient setting or in an intermediate care facility for behavioral health; (7) Services beyond the provider’s scope of practice; (8) Services that are separately billed but included as part of another service; (9) Buprenorphine induction and buprenorphine maintenance therapy services that are: (a) Delivered by a participant’s primary care provider which are the responsibility of the Managed Care Organization as specified in COMAR 10.67.08; or (b) Delivered without a primary diagnosis of substance use disorder; (10) Presumptive and definitive drug testing when billed by: (a) An opioid treatment program; (b) An intensive outpatient program; or (c) A partial hospitalization program provider; ( (11) Peer recovery support services that are not provided either in-person or via telehealth; and (12) Services not authorized consistent with this chapter. B. Providers may not be reimbursed by the Program for: (1) More than one comprehensive substance use disorder assessment for a participant per provider per 12-month period unless there is a break in treatment over 30 calendar days; (2) More than one Level 1 group counseling session per day per participant; (3) More than six Level 1 individual counseling units as measured in 15 minute increments per day per participant; (4) More than four sessions of Level 2.1 Intensive Outpatient treatment per week; (5) Level 1 group or individual counseling during the same week as a Level 2.1 Intensive Outpatient treatment or Level 2.5 Partial Hospitalization service unless the participant has been discharged from or admitted to a new level of care; (6) Overlapping episodes of Level 2.1 Intensive Outpatient treatment and Level 2.5 Partial Hospitalization; (7) Level 1 group or individual counseling during the same week as Level 1 group or individual counseling offered by another provider; (8) Psychiatric day treatment service as described in COMAR [10.09.02.01] 10.63.03.08 or an intensive outpatient mental health service on the same day as a Level 2.1 Intensive Outpatient program or Level 2.5 Partial Hospitalization program (9) Buprenorphine maintenance therapy delivered by an opioid treatment program or a BHA licensed substance use disorder treatment provider during the same week as Methadone Maintenance Therapy; (10) Ambulatory withdrawal management during the same week as an opioid maintenance therapy, medication assisted treatment induction, or buprenorphine maintenance service; (11) Medication management billed by an opioid treatment program or a BHA licensed substance use disorder treatment provider during the same days as medication assisted treatment induction; (12) Community-based substance use disorder services on the same day that a participant received similar services as a hospital inpatient or outpatient; (13) Services delivered by federally qualified health centers other than those billed using T-codes that may include the following delivered by two separate appropriately licensed providers: (a) One T-code for mental health services per day with associated mental health procedure code; and (b) One T-code for substance use disorder services with associated H-code per day; (14) Services rendered but not appropriately documented to the level of service; (15) Services rendered by mail; (16) Completion of forms or reports; (17) Broken or missed appointments; (18) Travel to and from site of service; and (19) Transportation costs. C. In order to bill for an individual in Level 2.1 Intensive Outpatient treatment, the per diem session shall include a minimum of 2 hours. A maximum of 4 per diems may be billed per week. D. In order to bill for an individual in Level 2.5 Partial Hospitalization, the per diem rate for a half day session shall include a minimum of 2 hours. E. In order to bill for an individual in Level 2.5 Partial Hospitalization, the per diem rate for a full day session shall include a minimum of 6 hours. F. The Department shall pay participating opioid treatment programs, per participant, per week provided the participant received ongoing opioid treatment medications and at least one face-to-face documented treatment service in the month for which the Program is billed. G. In order for an opioid treatment program to bill for medication assisted treatment induction, the provider shall bill this service only in the first week of treatment per participant or in the first week of treatment after a break from treatment of at least 6 months. H. In order for an opioid treatment program to bill for buprenorphine maintenance therapy, the provider shall bill this service per participant per week. I. In order to bill for ambulatory withdrawal management, providers may bill up to 5 per diems during the detoxification episode if determined medically necessary by the Department. J. Peer recovery support services may not be used to supplant the minimum billing requirements for: (1) Level 2.1 Intensive Outpatient treatment as described in §C of this regulation; (2) Level 2.5 Partial Hospitalization half day session as described in §D of this regulation; (3) Level 2.5 Partial Hospitalization full day session as described in §E of this regulation; and (4) Opioid treatment program services as described in §F of this regulation. K. All drug screening lab claims submitted to the ASO by providers other than opioid treatment programs shall list the applicable substance use disorder diagnosis. #### Regulation .07 Authorization Requirements. *COMAR 10.09.80.07* A. For services outlined in Regulation .05 of this chapter, the community-based substance use disorder program shall notify the ASO and obtain authorization to provide substance use disorder services from the ASO. B. The ASO agent shall authorize services that are: (1) Medically necessary; and (2) Of a type, frequency, and duration that are consistent with expected results and cost-effectiveness. C. No payment shall be rendered for services that have not been authorized by the Department or its designee. #### Regulation .08 Payment Procedures. *COMAR 10.09.80.08* A. General policies governing payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. B. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. C. Unless the care is free to other patients, a provider shall bill the Program their usual and customary charge to the general public. D. For dates of service July 1, 2023 through December 31, 2023, rates for the services outlined in this chapter shall be as follows: (1) For services outlined in this regulation, as delivered through a BHA licensed substance use disorder treatment provider: (a) Comprehensive substance use disorder assessment — $198.35; (b) Level 1 group substance use disorder counseling — $54.49 per session; (c) Level 1 individual substance use disorder counseling — $27.93 per 15-minute increment with a maximum of six 15-minute increments per day; (d) Level 2.1 Intensive Outpatient treatment — $174.60 per diem; (e) Level 2.5 Partial Hospitalization half day session — $181.58 per diem; (f) Level 2.5 Partial Hospitalization full day session — $293.31 per diem; (g) Ambulatory Withdrawal Management —$97.78 per diem; (h) Individual peer support services — $16.87 per 15-minute increment; (i) Group peer support services — $4.69 per 15-minute increment; (j) Point of care presumptive drug test read with direct optical observation only — $10.02 per test; (k) Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test; (l) Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and (m) Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. (2) For services outlined in this regulation as delivered through an opioid treatment program: (a) Comprehensive substance use disorder assessment — $198.35; (b) Level 1 group substance use disorder counseling — $54.49 per session; (c) Level 1 individual substance use disorder counseling — $27.93 per 15-minute increment with a maximum of six 15-minute increments per day; (d) Opioid Maintenance Therapy — $86.27 per participant per week; (e) Medication Assisted Treatment Induction — $279.36 per participant per week; (f) Buprenorphine Maintenance Therapy — $76.69 per participant per week; (g) Individual peer support services — $16.87 per 15-minute increment; (h) Group peer support services — $4.69 per 15-minute increment; and (i) Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. E. For dates of service January 1, 2024, through June 30, 2024, rates for the services outlined in this chapter shall be as follows: (1) For services outlined in this chapter, as delivered through a BHA licensed substance use disorder treatment provider: (a) Comprehensive substance use disorder assessment — $214.22; (b) Level 1 group substance use disorder counseling — $58.85 per session; (c) Level 1 individual substance use disorder counseling — $30.16 per 15-minute increment with a maximum of six 15-minute increments per day; (d) Level 2.1 Intensive Outpatient treatment — $188.57 per diem; (e) Level 2.5 Partial Hospitalization half day session — $196.11 per diem; (f) Level 2.5 Partial Hospitalization full day session — $316.77 per diem; (g) Ambulatory Withdrawal Management —$105.60 per diem; (h) Individual peer support services — $18.22 per 15-minute increment; (i) Group peer support services — $5.07 per 15-minute increment; (j) Point of care presumptive drug test read with direct optical observation only — $10.02 per test; (k) Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test; (l) Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and (m) Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. (2) For services outlined in this chapter as delivered through an opioid treatment program: (a) Comprehensive substance use disorder assessment — $214.22; (b) Level 1 group substance use disorder counseling — $58.85 per session; (c) Level 1 individual substance use disorder counseling — $30.16 per 15-minute increment with a maximum of six 15-minute increments per day; (d) Opioid Maintenance Therapy — $93.17 per participant per week; (e) Medication Assisted Treatment Induction — $301.71 per participant per week; (f) Buprenorphine Maintenance Therapy — $82.83 per participant per week; (g) Individual peer support services — $18.22 per 15-minute increment; (h) Group peer support services — $5.07 per 15-minute increment; and (i) Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. F. Effective July 1, 2024, rates for the services outlined in this chapter shall be as follows: (1) For services outlined in this chapter, as delivered through a BHA licensed substance use disorder treatment provider: (a) Comprehensive substance use disorder assessment — $220.65; (b) Level 1 group substance use disorder counseling — $60.62 per session; (c) Level 1 individual substance use disorder counseling — $31.06 per 15-minute increment with a maximum of six 15-minute increments per day; (d) Level 2.1 Intensive Outpatient treatment — $194.23 per diem; (e) Level 2.5 Partial Hospitalization half day session — $201.99 per diem; (f) Level 2.5 Partial Hospitalization full day session — $326.27 per diem; (g) Ambulatory Withdrawal Management —$108.77 per diem; (h) Individual peer support services — $18.77 per 15-minute increment; (i) Group peer support services — $5.22 per 15-minute increment; (j) Point of care presumptive drug test read with direct optical observation only — $10.02 per test; (k) Point of care presumptive drug test read with instrument-assisted direct optical observation — $10.02 per test; (l) Point of care presumptive drug test read with instrumented chemistry analyzers — $49.40 per test; and (m) Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. (2) For services outlined in this chapter as delivered through an opioid treatment program: (a) Comprehensive substance use disorder assessment — $220.65; (b) Level 1 group substance use disorder counseling — $60.62 per session; (c) Level 1 individual substance use disorder counseling — $31.06 per 15-minute increment with a maximum of six 15-minute increments per day; (d) Opioid Maintenance Therapy — $95.97 per participant per week; (e) Medication Assisted Treatment Induction — $310.76 per participant per week; (f) Buprenorphine Maintenance Therapy — $85.31 per participant per week; (g) Individual peer support services — $18.77 per 15-minute increment; (h) Group peer support services — $5.22 per 15-minute increment; and (i) Periodic medication management through office-based evaluation and management visits, according to COMAR 10.09.02.07D. G. The Program shall make no direct payment to participants. H. The Department shall authorize supplemental payment on Medicare claims only if: (1) The provider accepts Medicare assignments; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that the services are medically necessary; (4) The services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. I. The Department shall make payment on Medicare claims subject to the following provisions: (1) Deductible and coinsurance shall be paid in full for services designated as mental health services by Medicare; and (2) The Program shall reimburse services not covered by Medicare, but considered medically necessary by the Program, according to the limitations of this chapter. #### Regulation .09 Recovery and Reimbursement. *COMAR 10.09.80.09* Recovery and reimbursement shall be as set forth in COMAR 10.09.36.07. #### Regulation .10 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.80.10* A. Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. B. The Department shall give to the provider reasonable written notice of the Department’s intention to impose sanctions. In the notice, the Department shall: (1) Establish the: (a) Effective date of the proposed action; and (b) Reasons for the proposed action; and (2) Advise the provider of the right to appeal. #### Regulation .11 Appeal Procedures. *COMAR 10.09.80.11* Appeals procedures shall be as set forth in accordance with COMAR 10.09.36.09. #### Regulation .12 Interpretive Regulation. *COMAR 10.09.80.12* This chapter shall be interpreted as set forth in COMAR 10.09.36.10. ### Chapter 81 — Increased Community Services (ICS) Program **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: June 11, 2012 (39:11 Md. R. 687) **Administrative History:** Regulation .40C amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .41 amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .41 repealed effective December 11, 2025 (52:23 Md. R. 1198) **Administrative History:** Regulation .41 adopted effective December 11, 2025 (52:23 Md. R. 1198) #### Regulation .01 Purpose. *COMAR 10.09.81.01* The purpose of the Increased Community Services (ICS) Program is to enable certain nursing facility residents to access home and community-based services by allowing those nursing facility residents to contribute to the cost of care through a monthly assessment and thus enabling those individuals to live at home with ICS and other Medicaid services instead of in a nursing facility. #### Regulation .02 Definitions. *COMAR 10.09.81.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means bathing, eating, toileting, dressing, and mobility including transfer. (2) “Adult Evaluation and Review Services (AERS)” means an entity within the local health department which, in accordance with this chapter and COMAR 10.09.30, evaluates ICS applicants and participants. (3) “Agency-employed attendant” means an attendant who is employed by, or under contract with, an attendant care provider agency. (4) “Applicant” means an individual who has submitted to the Department an application for the ICS Program. (5) “Assessment fee” means the fee the participant is required to pay as a condition of eligibility for the ICS Program and Medical Assistance benefits. (6) “Assistance” means that another individual: (a) Physically performs an activity for the participant; (b) Physically helps the participant to perform an activity; (c) Is present while the participant performs an activity because the participant's safety or health may be jeopardized if the activity is not monitored or performed due to the participant's physical or mental status; or (d) Cues or encourages the participant to perform the activity. (7) “Assisted living services provider” means a provider licensed by the Department in accordance with COMAR 10.07.14 and enrolled in the Maryland Medical Assistance Program to provide the services covered under Regulation .37 of this chapter. (8) “Attendant” means an individual who provides a participant with attendant care services. (9) “Attendant care provider agency” means an agency that is enrolled in the Maryland Medical Assistance Program to provide the services covered under Regulation .30 of this chapter. (10) “Attendant Care Services” means assistance with activities of daily living, instrumental activities of daily living, and performance of delegated nursing functions. (11) “Case management agency” means an agency enrolled by the Maryland Medical Assistance Program to provide case management services to ICS applicants and participants. (12) “Case management services” means services that assist an applicant or a participant to gain access to ICS services, Medicaid State Plan services, and other community services. (13) “Delegated nursing functions” means services, other than assistance with activities of daily living and instrumental activities of daily living, provided to a participant by: (a) An enrolled attendant under the supervision of an enrolled licensed registered nurse in accordance with COMAR 10.27.11; or (b) A nurse practitioner in accordance with COMAR 10.27.07. (14) “Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department. (15) “Determination” means a decision by the Department regarding an applicant's or participant's eligibility for the ICS Program. (16) “Fiscal intermediary” means an agency that is under contract with the Department to provide fiscal intermediary services. (17) “Fiscal intermediary services” means certain employer-related payroll functions, such as State and federal tax withholding and Social Security withholding, performed on behalf of participants who elect to use the participant-employed model of attendant care services. (18) Home. (a) “Home” means the place where the participant resides. (b) “Home” does not include a hospital, nursing facility, or other institution that is regulated under: (i) COMAR 10.22.03 for licensed community-based residential facilities for individuals with intellectual or developmental disabilities; or (ii) COMAR 10.21.22 for residential rehabilitation programs for individuals with serious or chronic mental illness. (19) "Increased Community Services (ICS) Program” means the Medicaid home and community-based services program implemented under this chapter in accordance with the HealthChoice Section 1115 Waiver approved by the Centers for Medicare and Medicaid Services. (20) “Instrumental activities of daily living” means tasks or activities that include: (a) Preparing a light meal; (b) Performing light chores; (c) Shopping for groceries; (d) Traveling beyond a walking distance; (e) Managing finances and handling money; (f) Using the telephone; and (g) Planning and making decisions. (21) “Maryland Medical Assistance Program” means the Program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for low income and medically indigent persons. (22) “Medicaid” means the Maryland Medical Assistance Program. (23) “Medical day care” means medically supervised, health-related services provided in an ambulatory setting to medically disabled adults who, because of the degree of impairment, need health maintenance and restorative services that support their community living. (24) “Medical day care center” means a facility operated for the purpose of providing medical day care services in an ambulatory care setting to medically disabled adults who do not require 24-hour inpatient care, but because of the degree of impairment, are not capable of full-time independent living. (25) “Medically necessary” means the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (26) “Nurse” means an individual who is currently licensed to practice nursing in the State. (27) “Nurse monitor” means a registered nurse who provides nursing supervision of attendants in accordance with COMAR 10.27.11 and this chapter. (28) “Nursing facility” means an institution which is licensed by the Department under COMAR 10.07.02. (29) “Nursing facility services” means services provided to individuals who do not require hospital care, but who, because of a mental or physical condition, require skilled nursing care and related services, rehabilitative services, or, on a regular basis, health-related care and services above the level of room and board. (30) “Nursing supervision” means a nurse monitor's supervision of an attendant in accordance with COMAR 10.27.11 and this chapter. (31) “Participant” means an individual who meets the qualifications for participation in the ICS program as specified in Regulation .03 of this chapter and is enrolled with the Department to receive ICS services. (32) “Participant-employed attendant” means an attendant who does not work for an attendant care provider agency and who may be chosen, trained, supervised, and fired by the participant. (33) “Participant-employed model” means the delivery of attendant care services when: (a) An ICS participant chooses the attendant who will render services; (b) The attendant is an enrolled Medicaid provider; and (c) The participant utilizes services of a fiscal intermediary. (34) “Plan of care” means the recommended or revised recommended service plan developed by AERS after an evaluation of an applicant or participant. (35) “Plan of service” means the written plan that: (a) Is developed jointly by the applicant or participant and the case manager; (b) Is based upon: (i) The AERS evaluation; (ii) The AERS plan of care; and (iii) The case manager's face-to-face interview with the applicant or participant; (c) Addresses the applicant's or participant's needs and desires; and (d) Specifies the type, amount, frequency, costs, and duration of all ICS and other Medicaid services required to safely support the participant in the community. (36) “Provider” means an entity which is enrolled in the Maryland Medical Assistance Program to provide one or more of the services covered under Regulations .22 — .37 of this chapter. (37) “Quality plan” means the plan developed by the Department to address quality assurance and oversight for the ICS program. (38) “Registered nurse” means an individual licensed to practice as a registered nurse under Health Occupations Article, Title 8, Annotated Code of Maryland. (39) “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food, which are provided in, or associated with, an individual’s place of residence. (40) “State Plan” means the document approved by the Centers for Medicare and Medicaid Services describing the nature and scope of the Maryland Medical Assistance Program in accordance with federal requirements at §1902(a) of Title XIX of the Social Security Act. #### Regulation .03 Participant Eligibility. *COMAR 10.09.81.03* A. General Requirements. (1) To be eligible for participation in the ICS Program, an applicant or participant shall be determined by the Department to meet the conditions of §§B — E of this regulation. (2) A participant's eligibility for ICS services shall be reevaluated by the Department every 12 months or more frequently if needed due to a significant change in the participant's condition, needs, or financial status. (3) The Department shall have 45 days from the date of a complete application to make an eligibility determination. B. Technical Eligibility. To be eligible for the services covered under this chapter, an applicant or participant shall be determined by the Department to meet the technical eligibility criteria for ICS services if the individual: (1) Had been living in a nursing facility at the time of application and for at least the last 6 months before the date of application and meets all eligibility requirements before transitioning into the community; (2) Had been eligible for Medicaid for at least 30 consecutive days immediately before being enrolled in the ICS Program; (3) Is not otherwise eligible for services covered under: (a) The authority of §1915(c) of Title XIX of the Social Security Act; or (b) The Programs of All-Inclusive Care for the Elderly under COMAR 10.09.44; (4) Is at least 18 years old; (5) Has a plan of service that: (a) Includes Medical Assistance and ICS services necessary to safely serve the participant in the community; and (b) Is determined by the Department to cost less than the cost to Medicaid if the individual were to remain in the institution; (6) Is offered the choice between ICS and nursing facility services; (7) Chooses, or the individual’s authorized representative chooses on the individual’s behalf, to receive ICS services; (8) Is being discharged from a nursing facility into ICS services in the community and would be institutionalized in a nursing facility if not for the ICS services; (9) Resides in a home, as defined under Regulation .02B of this chapter; and (10) Uses at least one ICS service within a 12-month period. C. Medical Eligibility. (1) An applicant shall be determined by the Department’s utilization control agent to need nursing facility services covered under COMAR 10.09.10. (2) Every 12 months, or more frequently if determined necessary by the Department due to a significant change in the participant's condition or needs, AERS shall revaluate the participant to verify the continued need for nursing facility services. D. Financial Eligibility. An ICS participant shall: (1) Without regard to any assets of a spouse, meet the resource limit for Long-Term Care Medical Assistance set forth in COMAR 10.09.24.08M; (2) Receive income, after all available disregards and exclusions set forth in COMAR 10.09.24.07L and 10.09.24.07J, without regard to any income of a spouse, that exceeds 300 percent of the current monthly Supplemental Security Income payment rate, known as the Federal Benefit Rate (FBR); (3) Pay to the Department an assessment fee equal to the amount by which income, after all available disregards and exclusions set forth in COMAR 10.09.24.07L and 10.09.24.07J, exceeds 300 percent of the FBR, as follows: (a) The initial assessment shall be paid to the Department not later than 15 days from the date of the assessment invoice sent by the Department to the participant, unless the exception in §D(4) of this regulation applies; (b) Subsequent assessments shall be paid on or before the last day of the month on which the assessment invoice is sent to the participant by the Department; and (c) If a participant receives a past due notice, the participant has 15 days from the date of the notice to remit payment; and (4) Be allowed an exception to the initial monthly assessment if discharged from the nursing facility on a date other than the first of the month, in which case the participant shall be required to pay the first assessment before the first day of the first full month of ICS participation. E. Medical Assistance Eligibility. (1) An individual is not eligible to receive ICS services during a penalty period under COMAR 10.09.24.08-1 or 10.09.24.08-2 due to disposal of assets or establishment of a trust. (2) All provisions of COMAR 10.09.24 which are applicable to aged, blind, or disabled institutionalized persons are applicable to ICS applicants and participants, with the following exceptions: (a) COMAR 10.09.24.06B(2)(a)(ii); (b) COMAR 10.09.24.08G(1); (c) COMAR 10.09.24.08H; (d) COMAR 10.09.24.10B(2) — (3); (e) COMAR 10.09.24.10C; (f) COMAR 10.09.24.10D(2)(a), (b), and (h); (g) COMAR 10.09.24.10D(3) — (6); (h) COMAR 10.09.24.10-1B(1); (i) COMAR 10.09.24.10-1B(4); (j) COMAR 10.09.24.10-1B(7); (k) COMAR 10.09.24.10-1C(3)(a); and (l) COMAR 10.09.24.15A-2(2). F. Cost of Care. (1) For a participant whose home is an assisted living facility, the Department shall reduce its monthly payment for assisted living services by the amount remaining after deducting from the individual's total nonexcluded monthly income the following amounts in the following order: (a) A personal needs allowance, consisting of the amount established in accordance with COMAR 10.09.24.10D(2)(c) and the assisted living provider's monthly charge to the participant for room and board; and (b) Incurred medical expenses in accordance with COMAR 10.09.24.10D(2)(f) and (g). (2) The Department shall determine the amount of available income to be paid by a participant towards the cost of assisted living services. (3) The participant shall pay the assisted living services provider directly for the participant’s cost of care and room and board. G. Participant Cap and Registry for ICS Participation. (1) The Department shall establish a cap, approved by the federal Centers for Medicare and Medicaid Services (CMS), on the number of participants who may receive the services covered under this chapter at any one time, based on available State and federal funding. (2) Eligible individuals shall be enrolled in the ICS Program on a first-come, first-served basis until the participant cap is reached. (3) Once the CMS-approved participant cap is reached, a registry of applicants shall be established by the Department on a first-come, first-served basis. H. Termination of Participation. A participant shall be terminated from participation in the ICS Program if the participant: (1) No longer meets the eligibility requirements specified in §§B — E of this regulation; (2) Voluntarily chooses, or the participant's legal representative chooses on the participant's behalf, to disenroll from the ICS Program; (3) Moves to another state; (4) Is an inpatient for 30 consecutive days or more in a hospital or nursing facility; or (5) Dies. I. Re-Entering the ICS Program. (1) If a participant is terminated from the ICS Program, the same individual may re-enter the ICS Program, provided: (a) That the individual meets all of the requirements §§B — E of this regulation; and (b) There is available capacity. (2) If an individual cannot find a community residence before his or her application expires, the individual may reapply to the ICS Program as long as the individual continues to meet all other eligibility requirements. #### Regulation .04 Conditions for Provider Participation — General Requirements. *COMAR 10.09.81.04* A. To participate as a provider of a service covered under Regulations .22 — .37 of this chapter, a provider shall: (1) Meet all of the conditions for participation as a Maryland Medical Assistance Program provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; (2) Meet the licensure and certification requirements specified in this chapter, if applicable; (3) Meet the applicable conditions for provider participation in this chapter; (4) Apply in accordance with the conditions of participation under Regulations .05 — .20 of this chapter, by completing the application forms designated by the Maryland Medical Assistance Program; (5) Have a signed provider agreement in effect with the Maryland Medical Assistance Program; (6) Verify the qualifications of all individuals who render ICS services on the provider's behalf, and provide a copy of the current license or credentials of these individuals upon request; (7) Provide services in accordance with: (a) A participant's plan of service; (b) The provider agreement; (c) The ICS Program; and (d) All relevant federal, State, and local laws and regulations; (8) Agree to inform the case manager within 24 hours, and within 7 calendar days file a written report on a form designated by the Department, in the case of any threat to the health, safety, or welfare of the participant such as: (a) Potential eviction; (b) Suspected abuse or neglect; or (c) Significant interruption of service; (9) Immediately notify the Adult Protective Services office at the local department of social services and law enforcement if the provider believes that the participant has been subjected to abuse, neglect, self-neglect, or exploitation in the community, in accordance with COMAR 07.06.14.04; (10) Agree to cooperate with required inspections, reviews, and audits by authorized governmental representatives; (11) Agree to provide services, and to subsequently bill the Department in accordance with the payment procedures specified at Regulation .40 of this chapter for only covered services which have been: (a) Preapproved in the participant's plan of service; (b) Provided in a manner consistent with the participant's plan of service; and (c) Authorized in the provider agreement as within the scope of the provider's Medicaid participation; (12) Agree to maintain and have available written documentation of ICS services, including dates and hours of services provided to participants for a period of 6 years, in a manner approved by the Department; (13) Agree not to suspend, terminate, increase, or reduce services for a participant without authorization from the participant’s case manager; and (14) Agree to comply with the requirements in the Department's quality plan for the ICS Program. B. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: (1) Been subject to sanctions under COMAR 10.09.36.08; (2) Had a license or certificate suspended or revoked as a health care provider, health care facility, or provider of direct care services; (3) Been subject to a disciplinary action by a licensing board; (4) Been cited by a State agency for deficiencies which affect recipients' health and safety; or (5) Been terminated under a reimbursement agreement with or been barred from work or participation by a public or private agency due to: (a) Failure to meet contractual obligations; or (b) Fraudulent billing practices. C. A provider who renders health-related services to participants, including attendants, participant trainers, occupational therapists, speech and language therapists, physical therapists, nutritionists, dietitians, medical day care centers, and registered nurses, shall agree to: (1) Periodically indicate the condition of a participant in accordance with the procedures and forms designated by the Department; and (2) Share and discuss the documented information at the request of the participant. #### Regulation .05 Specific Conditions for Provider Participation — Participant Training. *COMAR 10.09.81.05* To participate in the ICS Program as a provider of participant training under Regulation .22 of this chapter, a provider shall: A. Be a self-employed trainer or an agency that employs qualified trainers in accordance with §§B and C of this regulation; B. Demonstrate experience in the skill being taught; and C. Be willing to meet at the participant's home to provide services. #### Regulation .06 Specific Conditions for Provider Participation — Family Training. *COMAR 10.09.81.06* To participate in the ICS Program as a provider of family training services under Regulation .23 of this chapter, a provider shall: A. Be: (1) One of the following self-employed professionals: (a) Registered nurse or nurse practitioner licensed according to COMAR 10.27.01 and 10.27.07; (b) Occupational therapist licensed according to COMAR 10.46.01; (c) Speech-language pathologist licensed according to COMAR 10.41.03; or (d) Physical therapist licensed according to COMAR 10.38.01; or (2) An agency which employs or contracts with a licensed professional specified in §A(1) of this regulation who will render the service; and B. Demonstrate experience in the skill being taught. #### Regulation .07 Specific Conditions for Provider Participation — Case Management Services. *COMAR 10.09.81.07* To participate in the ICS Program as a provider of case management services under Regulation .24 of this chapter, a provider shall: A. Be enrolled as a case management provider in accordance with COMAR 10.09.55.15-3; B. Accept all referrals from the Department, or other designated agency; and C. Be monitored by the Department. #### Regulation .08 Specific Conditions for Provider Participation — Transition Services. *COMAR 10.09.81.08* To participate in the ICS Program as a provider of transition services under Regulation .25 of this chapter, a provider shall be the case management provider in accordance with Regulation .07 of this chapter and shall: A. Assist individuals to transition from a nursing facility to a community-based residence; and B. Arrange and coordinate the services necessary to facilitate the transition. #### Regulation .09 Specific Conditions for Provider Participation — Environmental Assessments. *COMAR 10.09.81.09* To participate in the ICS Program as a provider of environmental assessments under Regulation .26 of this chapter, a provider shall: A. Be a licensed occupational therapist, or an agency or professional group employing a licensed occupational therapist; B. Receive a referral from the participant's case manager, based on services preauthorized in the plan of service; and C. Document the provider's findings and recommendations on a form approved by the Maryland Medical Assistance Program. #### Regulation .10 Specific Conditions for Provider Participation — Environmental Accessibility Adaptations. *COMAR 10.09.81.10* A. To participate in the ICS Program as a provider of environmental accessibility adaptations under Regulation .27 of this chapter, a provider shall: (1) Be the store, vendor, or contractor, from which the adaptation is purchased; (2) Provide or arrange for any required installation, servicing, or training; and (3) Provide services according to a written schedule indicating an estimated start date and completion date. B. If construction is involved, the provider shall also meet the following requirements: (1) Be properly licensed by the State as a contractor or builder; (2) Be properly bonded; (3) Obtain all necessary State and local permits; (4) Ensure that the work passes the required inspections; and (5) Perform all work in accordance with State and local building codes. #### Regulation .11 Specific Conditions for Provider Participation — Personal Emergency Response Systems. *COMAR 10.09.81.11* To participate in the ICS Program as a provider of personal emergency response systems under Regulation .28 of this chapter, a provider shall: A. Be the store, vendor, organization, or company which sells, rents, installs, services, or runs the device or service; B. Provide or arrange for any installation, servicing, training, or monitoring required for the device or system; and C. Assure that any response center is: (1) Responsible for monitoring or responding to a notification of an emergency by the system; and (2) Adequately staffed 24 hours a day, 7 days a week by properly trained staff. #### Regulation .12 Specific Conditions for Provider Participation — Assistive Technology. *COMAR 10.09.81.12* To participate in the ICS Program as a provider of assistive technology services under Regulation .29 of this chapter, a provider shall: A. Be one of the following entities: (1) The store, vendor, organization, or company which sells or rents the equipment or system; or (2) A Maryland Medical Assistance Program provider of disposable medical supplies and durable medical equipment under COMAR 10.09.12; B. Provide or arrange for any installation, servicing, training, or monitoring required for the proper operation of the equipment or system; and C. Provide services in accordance with written estimated start and completion dates. #### Regulation .13 Specific Conditions for Provider Participation — Attendant Care Services. *COMAR 10.09.81.13* A. To participate in the ICS Program as a provider of attendant care services under Regulation .30 of this chapter, unless otherwise exempted under §F of this regulation, an attendant shall: (1) Be a participant-employed or agency-employed attendant; (2) Be at least 18 years old; (3) Be legally eligible for employment rendering attendant care services in the State; (4) Be able to communicate, read, write, and follow directions in English; (5) Be currently certified from a nationally recognized organization in the following areas: (a) Cardiopulmonary resuscitation; and (b) Basic first aid; (6) Receive instruction and training on the attendant care services required in the participant's plan of service from the nurse monitor before rendering services; (7) Be supervised by a nurse monitor in accordance with the requirements of Regulation .31 of this chapter; (8) Accept instruction and training from: (a) The participant; (b) The nurse monitor; (c) The case manager; (d) A treating physician; (e) Other involved professionals; or (f) A Department representative; (9) Submit to a pre-employment criminal background investigation for which the individual shall: (a) Submit an application for a criminal history record check to the Criminal Justice Information System Office, Department of Public Safety and Correctional Services; (b) Direct the Department of Public Safety and Correctional Services to send the criminal history report to the Department; and (c) Pay for the criminal history record check and report; and (10) Agree to submit written documentation of services rendered to each participant to the case manager on a form designated by the Department. B. To participate in the ICS Program as a provider of attendant care services under Regulation .30 of this chapter, unless otherwise exempted under §F of this regulation, an attendant may not: (1) Be a spouse; (2) Be a parent of a dependent child; (3) Be an individual who has full and unrestricted powers of guardianship; (4) Render services to any participant before being evaluated by a nurse monitor as able to: (a) Understand and carry out the attendant care services specified in the participant's plan of service; and (b) Perform the required duties; (5) Unless meeting the conditions of §C of this regulation, have been convicted of, received a probation before judgment for, or entered a plea of nolo contendere to, a felony or any crime involving moral turpitude, drugs, or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; or (6) Be listed on the Maryland Geriatric Nursing Assistants Registry or any other registry with a determination of abuse, misappropriation of property, or neglect. C. If requested by the provider applicant, the Department may waive the provisions of §B(5) of this regulation if the applicant demonstrates that: (1) The conviction, probation before judgment, or a plea of nolo contendere to a felony or any crime involving moral turpitude, drugs, or theft was entered more than 10 years before the date of the provider application; and (2) The criminal history does not indicate behavior that is potentially harmful to participants. D. If required to perform any delegated nursing functions as defined in Regulation .02B of this chapter, an attendant who meets the requirements of §§A and B of this regulation, shall also: (1) Be certified as: (a) A nursing assistant in accordance with COMAR 10.39.01; or (b) If required to administer medications: (i) Certified medicine aide in accordance with COMAR 10.39.03; or (ii) Medication technician in accordance with COMAR 10.39.04; (2) Be supervised by a nurse monitor; and (3) Comply with the requirements of the Maryland Board of Nursing as set forth in COMAR 10.27.11. E. To participate in the ICS Program as an agency provider of attendant care services, a provider agency shall: (1) Be one of the following: (a) A public or private agency that has been approved by the Department of Human Services, in accordance with COMAR 07.06.14; (b) A Medicaid provider of: (i) Home health services under COMAR 10.09.04; or (ii) Personal care services under COMAR 10.09.20.03B; or (c) A residential services agency certified in accordance with COMAR 10.07.05; (2) Employ or contract with attendants, who meet the requirements in §§A — C of this regulation, in sufficient numbers to ensure that a qualified attendant is available to provide the attendant care services ordered in the plan of service; (3) Supervise each attendant who is employed by or under contract with the attendant care provider agency; (4) Employ or contract with licensed registered nurses to act as nurse monitors and provide nursing supervision, in accordance with Regulations .14 and .31 of this chapter; (5) Be available to give instructions to attendants and to answer questions during a normal working day, including having a nurse monitor available to respond to medical or health-related issues that are within the scope of the nurse's license; (6) Keep accurate records on each participant receiving attendant care services from the agency, which contain: (a) The plan of service; (b) Identification of each attendant providing services to the participant; (c) Dates and times when attendants worked; (d) Tasks the attendants performed; (e) Nurse monitors' instructions to the attendants; and (f) Progress notes and observations on the attendant and the participant; (7) Keep records and submit reports as required by the Department; (8) Maintain 24-hour availability by beeper for emergencies; and (9) Submit written documentation of services rendered to each participant as required by the Maryland Medical Assistance Program and on a form designated by the Department. F. Exemptions. (1) Subject to approval by the Department, participant-employed attendants may be exempted from the qualifications described at §A(2), (4), and (5) of this regulation at the request of the participant. (2) Providers that have been exempted from any qualification may only serve the participant or participants who have requested the exemption. (3) The Department may: (a) Grant exemptions; and (b) Revoke exemptions for cause. #### Regulation .14 Specific Conditions for Provider Participation — Nursing Supervision of Attendants. *COMAR 10.09.81.14* A. To participate in the ICS Program as a provider of nursing supervision of attendants under Regulation .31 of this chapter, a provider shall be: (1) A self-employed registered nurse or nurse practitioner licensed according to COMAR 10.27.01 and 10.27.07; or (2) An agency or clinic which employs registered nurses or nurse practitioners licensed according to COMAR 10.27.01 and 10.27.07. B. The registered nurse or nurse practitioner who renders nursing supervision services shall: (1) Be an individual who is: (a) Self-employed; or (b) Employed by or under contract with an agency as specified in §A(2) of this regulation; (2) Meet the requirements of the Maryland Board of Nursing regarding nursing services and delegation of nursing functions in accordance with COMAR 10.27.11; (3) Be willing to delegate nursing tasks to unlicensed, certified individuals according to COMAR 10.27.11; and (4) Maintain detailed, written documentation of services rendered to participants including progress notes and service outcomes, as specified by the Department. C. A provider shall ensure that a nurse monitor is available to provide the nursing supervision services specified in Regulation .31 of this chapter. #### Regulation .15 Specific Conditions for Provider Participation — Home Delivered Meals. *COMAR 10.09.81.15* To participate in the ICS Program as a provider of home-delivered meals under Regulation .32 of this chapter, a provider shall: A. Be approved and monitored by the Department; and B. Use a cooking facility or food preparation site that: (1) Has a food service license issued by the local health department, in accordance with COMAR 10.15.03, or an appropriate license from the state in which the site is located; and (2) Is approved for each licensing renewal based on inspections performed by State sanitarians in accordance with COMAR 10.15.03, or by the licensing authority in the state in which the site is located. #### Regulation .16 Specific Conditions for Provider Participation — Dietitian and Nutritionist Services. *COMAR 10.09.81.16* To participate in the ICS Program as a provider of dietitian and nutritionist services under Regulation .33 of this chapter, a provider shall be a: A. Dietitian or nutritionist who is licensed in accordance with COMAR 10.56.01 and Health Occupations Article, Title 5, Annotated Code of Maryland; or B. Professional group or agency which employs an individual who is licensed in accordance with §A of this regulation. #### Regulation .17 Specific Conditions for Participation — Behavior Consultation Services. *COMAR 10.09.81.17* To participate in the ICS Program as a provider of behavior consultation services, as specified in Regulation .34 of this chapter, a provider shall: A. Be: (1) A health services agency that: (a) Employs a qualified individual or individuals to render behavior consultation services; and (b) Assures supervision of, or consultation to, the individual rendering behavior consultation services by a licensed mental health professional or by a bachelor's level nurse with 4 years of experience in psychogeriatrics or with an appropriate graduate degree; or (2) An individual who is: (a) Qualified to render behavior consultation services; and (b) Licensed to practice independently; B. Assure that the individual who renders behavior consultation services: (1) Is a licensed Registered nurse; Psychologist; or Clinical social worker; and (2) Has: (a) Experience in psychogeriatrics; (b) Direct experience working with elderly individuals with dementia or behavioral problems; and (c) Demonstrated ability to perform assessments; and C. Assure response within 24 hours to a referral from a participant's case manager for behavior consultation services. #### Regulation .18 Specific Conditions for Provider Participation — Medical Day Care. *COMAR 10.09.81.18* To participate in the ICS Program as a provider of medical day care services under Regulation .35 of this chapter, a provider shall: A. Be licensed according to COMAR 10.12.04; and B. Meet the requirements of COMAR 10.09.07. #### Regulation .19 Specific Conditions for Participation — Senior Center Plus. *COMAR 10.09.81.19* To participate in the ICS Program as a provider of Senior Center Plus services, as specified in Regulation .36 of this chapter, a provider shall: A. Be approved and monitored by the Maryland Department of Aging as a nutrition service provider; B. Meet all local and State requirements to operate as a nutrition site, which include but are not limited to inspection and approval of the facility by the local fire marshal, periodic fire drills, and inspection and approval by the local sanitarian to assure compliance with health department requirements for food service facilities; C. Assure that the facility is accessible to individuals with disabilities; D. Maintain adequate records on participants, including progress notes and outcomes; E. Provide at least one staff person per eight clients, with additional staffing if required by the Maryland Department of Aging depending on participants' functional levels; F. Employ as the center's manager or in another staff position an individual who: (1) Is a licensed health professional or a licensed social worker; (2) Has at least 3 years’ experience in direct patient care at an adult day care center, nursing facility, or health-related facility; (3) Is literate and able to communicate in English; and (4) Participates in training specified and approved by the Maryland Department of Aging; G. Provide Senior Center Plus services, as specified in Regulation .36 of this chapter, to participants at least 4 hours a day, 1 or more days a week on a regularly scheduled basis, in an out-of-home, outpatient setting; H. Serve at least one nutritional meal per day that: (1) Is prepared in a licensed food service establishment; (2) Meets at least one-third of the daily recommended dietary allowance; and (3) Does not constitute a full nutritional regimen of three meals per day; I. Serve snacks, as desired by the participants, when the day program exceeds 6 hours; and J. Have menus reviewed and approved quarterly by a registered dietitian for nutritional adequacy. #### Regulation .20 Specific Conditions for Participation — Assisted Living. *COMAR 10.09.81.20* A. To participate in the ICS Program as an assisted living services provider, a provider shall: (1) Be licensed by the Department at the time that services are rendered, in accordance with COMAR 10.07.14, to provide assisted living services: (a) At the Level 2 moderate level of care or Level 3 high level of care; and (b) For the level of care needed by each participant residing in the facility, including any needed resident-specific waiver in accordance with COMAR 10.07.14.09; (2) Meet the requirements of COMAR 10.07.14 for Assisted Living Programs; (3) Be or employ a manager who is literate, able to communicate in English, and qualified as: (a) A licensed physician; (b) A licensed registered nurse; (c) A licensed practical nurse; or (d) An individual with at least 3 years’ experience in direct patient care in a private home, certified home, or health-related facility; (4) Employ an alternate assisted living manager who meets the requirements as specified in §A(3) of this regulation; (5) Have at least one staff person per eight residents on duty at all times during daytime hours, and a staff-to-resident ratio at night sufficient to provide the required services and maintain the facility in a safe and orderly condition, and such additional staffing as required by the Department or the Maryland Department of Aging depending on residents' functional levels; (6) Participate in training on the ICS Program billing process and other ICS Program requirements, as specified by the Department and the Maryland Department of Aging; (7) Have appropriate insurance coverage for the provider and its employees and vehicles if the provider transports participants to medical, social, recreational, and other services; (8) Cooperate with other service providers and quality assurance monitors by: (a) Facilitating on-site visits of authorized quality assurance monitors to review compliance with ICS and regulatory requirements; (b) Facilitating a case manager's on-site visits to the facility, which shall occur at least quarterly, to review the facility, regulatory compliance, service provision, and participants' status and needs; (c) Communicating with a participant's case manager concerning the participant's status, needs, and service provision; (d) Informing the case manager within 1 working day of any significant change in the participant's status and service needs; (e) Facilitating, as necessary and appropriate, the delivery of authorized ICS and State Plan services in the plan of service; and (f) Facilitating the ICS participant's relocation to comparable housing, if necessary, including transfer of all personal belongings and financial arrangements; and (9) Submit claims consistent with the provisions of Regulation .40 of this chapter. B. Bed Reservations. If bed reservations are offered to participants who are absent from an assisted living facility, the bed reservations policy shall: (1) Be provided to all residents and, where appropriate, the resident's representative, at admission; (2) Be fairly and consistently applied to all residents; (3) Specify that the bed reservation service is not a Medicaid covered service; (4) Clearly state that it is the resident's decision whether to reserve the bed; and (5) Specify that the participant's payments for bed reservation days may not exceed the full Medicaid per diem rate for Level II or Level III assisted living services, as applicable. C. Designated Units. An assisted living provider may limit Medicaid participation to designated units only if approved by the Maryland Department of Aging and the facility resident agreement contains the following provision: The facility's participation in the Maryland Medical Assistance Program is limited to one or more designated units and, in order to access Medicaid benefits, the resident shall reside in a designated unit. #### Regulation .21 Covered Services — General. *COMAR 10.09.81.21* The Maryland Medical Assistance Program shall reimburse for the services specified in Regulations .22 — .37 of this chapter when, pursuant to the requirements of this chapter, these services have been preapproved by the Department in the participant's plan of service and documented as: A. Necessary to prevent institutionalization in a nursing facility; and B. Cost-neutral to the ICS Program, in accordance with Regulation .38E of this chapter. #### Regulation .22 Covered Services — Participant Training. *COMAR 10.09.81.22* A. Definition. “Unit of service” means an hour of service rendered one-on-one by a qualified provider to a participant, not including the time spent by the provider: (1) Planning, preparing, or setting up the training; (2) Following up after the training; or (3) Traveling to and from the training. B. Participant training includes instruction and skill building in such areas as how to recruit, select, train, direct, supervise, and fire participant-employed attendants, money management, budgeting, independent living, meal planning, and other areas specified in the participant's plan of service. C. The topics covered by participant training shall: (1) Be specified in the participant's plan of service as necessary to safely maintain the participant at home; (2) Be targeted to the individualized needs of the participant; and (3) Be sensitive of the educational background, culture, and general environment of the participant. D. Participant training shall include updates as necessary to maintain or improve skills, if these updates are in the plan of service. #### Regulation .23 Covered Services — Family Training. *COMAR 10.09.81.23* A. Definitions. (1) “Family member” means an individual who: (a) Lives with or provides assistance to the participant; and (b) Is not paid to provide the care. (2) “Unit of service” means an hour of service rendered by a qualified provider to one or more family members at the same time in the participant's home or the provider's office, regardless of the number of family members trained at one time, not including the time spent by the provider: (a) Planning, preparing, or setting up the training; (b) Following up after the training; or (c) Traveling to and from the training. B. Family training includes instruction about treatment regimens and the use of equipment specified in the plan of service. C. The topics covered by family training shall be: (1) Specified in the participant's plan of service as necessary to safely maintain the participant at home; (2) Targeted to address the individualized needs of the participant; and (3) Sensitive of the educational background, culture, and general environment of the family member. D. Family training shall include updates in the plan of service as necessary to continue to safely maintain the individual at home. #### Regulation .24 Covered Services — Case Management. *COMAR 10.09.81.24* A. Definition. “Unit of service” means a 15-minute increment of service rendered by a qualified provider to a participant or the participant's representative. B. Case management services shall be targeted to address the individualized needs of the participant and be sensitive to the educational background, culture, and general environment of the participant. C. Case management services include time spent by a qualified provider conducting any of the following activities: (1) Assisting with an initial or annual ICS Program eligibility process; (2) Assisting with an application and maintaining all public and private benefits, resources, and entitlements; (3) Conducting an assessment of needs, and developing a person-centered plan of services, to include all services needed to live safely in the community; (4) Assisting with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the individual's needs including, but not limited to: (a) Community integration; (b) Medical services; (c) Social services; (d) Educational services; (e) Behavioral health; (f) Legal services; and (g) Housing; (5) Contacting ICS Program providers and Medicaid State Plan providers not less than monthly and documenting that services were received in the amount, type, frequency, and duration described in the plan of services; (6) Ensuring timely receipt of all other services and documenting follow-up; (7) Facilitating referral to other programs if the individual is denied ICS Program services; and (8) Using information technology systems developed by the Department. #### Regulation .25 Covered Services — Transition Services. *COMAR 10.09.81.25* A. Definition. “Unit of service” means a one-time service that is: (1) Not otherwise available under the ICS Program; (2) Approved in the plan of service; and (3) Rendered to a participant by a qualified provider to assist the participant in transitioning from a nursing facility or assisted living facility to independent living. B. Transition services may include some or all of the following: (1) Security deposits; (2) Essential furnishings and moving expenses; (3) Deposits or fees for utility services; and (4) Other health and safety assurances including pest eradication. C. Transition services may not include recreational items such as televisions, cable TV access, or DVD players. #### Regulation .26 Covered Services — Environmental Assessments. *COMAR 10.09.81.26* A. Definition. “Unit of service” means the completion of: (1) An on-site environmental assessment of the participant’s home; and (2) A form approved by the Maryland Medical Assistance Program. B. An environmental assessment may not be provided before the effective date of the participant's eligibility for ICS Program services. C. The service may be recommended by a multidisciplinary team in the plan of service for a participant when the service is considered necessary to: (1) Ensure the health and safety of a participant with special environmental needs; and (2) Obtain additional professional advice from an occupational therapist about the: (a) Physical structure of a participant's home or residence; and (b) Functional or mental limitations or disabilities of a participant as they relate to the environment. D. Included in the environmental assessment, as necessary and appropriate, may be: (1) An evaluation of the presence and likely progression of a disability or a chronic illness or condition in a participant; (2) Environmental factors in the facility or home; (3) The participant's ability to perform activities of daily living; (4) The participant's strength, range of motion, and endurance; (5) The participant's need for assistive devices and equipment; and (6) The participant's, family's, or service provider's knowledge of health, safety, and stress reduction factors. E. Based on an inspection of the home and interviews with the participant, family, or service provider, the provider shall complete a form, to be reviewed by the case manager, which details the provider's findings and recommendations as to a participant's need for ICS Program services. #### Regulation .27 Covered Services — Environmental Accessibility Adaptations. *COMAR 10.09.81.27* A. Definition. “Unit of service” means one or more physical adaptations to a participant's home or place of residence which is completed as one job by a qualified provider and which constitute a single accessibility adaptation. B. If the owner of the home is the participant, environmental accessibility adaptations may be made only if approved by the participant, in the participant's plan of service. C. If the owner is not the participant, environmental accessibility adaptations may be made only if approved by the owner of the home, who agrees that the participant will be allowed to remain in the residence for at least 1 year, and if approved by the participant, in the participant’s plan of service. D. Environmental accessibility adaptations shall include those physical adaptations or modifications to the participant's home which are required to make it accessible to the participant because of the: (1) Physical structure of the residence; or (2) Participant's specific functional needs. E. Environmental accessibility adaptations may include but are not limited to: (1) Visual fire alarms; (2) Telecommunication type machines (TTYs); (3) Ramps; (4) Grab bars or handrails; (5) Stair glides; (6) Widening of doorways; (7) Modification of bathroom or kitchen facilities to make them physically accessible; (8) Specialized electrical and plumbing systems to accommodate the medical equipment and supplies which are necessary for the participant's welfare; (9) Locks, buzzers, or other devices on doorways to prevent or stop wandering; and (10) Home modifications to help a participant identify the physical environment. F. To be reimbursed, all services shall: (1) Be provided in accordance with applicable State and local building codes; and (2) Pass required inspections. #### Regulation .28 Covered Services — Personal Emergency Response Systems. *COMAR 10.09.81.28* A. Definition. “Unit of service” means any of the following: (1) Purchase and installation; (2) Maintenance or repair; or (3) Monthly cost of a covered system or rented device or equipment. B. A personal emergency response system is an electronic device or system which enables a participant to secure help in an emergency and may include: (1) A device connected to the participant's telephone or other device and programmed to signal, upon activation of a help button, a response center with properly trained staff on duty 24 hours a day, 7 days a week; (2) A portable help button to allow for the participant's mobility; and (3) A motion detector when necessary for the participant's health, safety, and welfare. #### Regulation .29 Covered Services — Assistive Technology. *COMAR 10.09.81.29* A. Definition. “Unit of service” means a device or appliance that is purchased as one item, including: (1) Any required training in the use of the device; and (2) An assessment for the use of the device, if the assessment is: (a) Performed directly by the provider; and (b) Routinely included as part of the provider's cost for the item. B. Assistive technology includes nonexperimental technology or adaptive equipment, excluding service animals, which enables a participant to live in the community and to participate in community activities. C. Assistive technology may include: (1) Environmental control units for participants' homes to allow spontaneous or programmed control of household appliances and other home devices; (2) Personal computers, software, and computer accessories which enable participants to function more independently; (3) Maintenance and repair of the covered assistive technology devices and equipment; (4) Augmentative communication and communication-enhancement devices; (5) Aids for daily living and self-help aids used in activities such as eating, bathing, cooking, dressing, toileting, and home maintenance; and (6) Equipment needed to adapt the participant's or family's automotive vehicle for personal transportation such as: (a) Adaptive driving aids; (b) Hand controls; and (c) Wheelchair lifts, and other lifts used for personal transportation. D. To be covered under this chapter, each item of assistive technology shall meet applicable standards of manufacture, design, usage, and installation. #### Regulation .30 Covered Services — Attendant Care Services. *COMAR 10.09.81.30* A. Definition. “Unit of service” means an hour of service that is in the plan of service and rendered to a participant by a qualified provider in the participant's home or in a community setting. B. Except as provided in §C of this regulation, the ICS Program covers the following attendant care services: (1) Assistance with activities of daily living; (2) Delegated nursing functions, such as assistance with the participant's administration of medications or other remedies, when ordered by a physician, if this assistance is: (a) Specified in the participant's plan of service; and (b) Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing; (3) Assistance with protecting a participant from harm or neglect; (4) Assistance with instrumental activities of daily living, provided as incidental to the services covered under §B(1) — (3) of this regulation; and (5) Accompanying the participant outside of the home during the participant's community activities. C. Attendant care services may not include: (1) Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant; (2) The cost of food or meals; (3) Housekeeping services, other than those incidental services covered under §B(4) of this regulation; (4) Expenses related to room and board for either the participant or the attendant; (5) Expenses incurred while escorting a participant to obtain medical diagnosis or treatment; or (6) Skilled medical services performed by individuals with a professional medical license or certification. #### Regulation .31 Covered Services — Nursing Supervision of Attendants. *COMAR 10.09.81.31* A. Definition. “Unit of service” means an hour of service rendered by a nurse monitor to a participant in the participant's home or another community-based setting. B. Nursing supervision services include the following: (1) Development of the participant's plan for attendant care: (a) After consultation with the participant, family members, participant's personal physician, case manager, and other providers; and (b) In conformance with the participant's: (i) AERS evaluation; (ii) AERS plan of care; and (iii) Plan of service; (2) Providing health-related information and training to the attendant concerning topics related to the care, or progress, of the participant, including: (a) The performance of the services in the participant's plan for attendant care; and (b) Information that should be brought to the attention of the attendant care provider agency, the nurse monitor, personal physician, or case manager; (3) Ensuring that each attendant to be supervised by the provider meets the requirements in Regulation .13A, B, and D of this chapter; (4) Nursing supervision of the participant's medical condition and the care rendered by an attendant, including any delegated nursing functions performed by an attendant, in accordance with COMAR 10.27.11 and the schedule specified in §B(5) of this regulation, by reviewing the: (a) Participant's plan of service and specific plan for attendant care; (b) Interactions between the participant and the attendant; (c) Attendant's performance and ability to render the required services; and (d) Participant's medical condition and need for attendant care services or for referral to other services; (5) Providing the necessary type and frequency of nursing supervision required in accordance with COMAR 10.27.11, with the exception of COMAR 10.27.11.04C, including visits to a participant's home or other service delivery site for observation at least every: (a) 45 days if the attendant administers medications to the participant; (b) 3 months if the attendant assists the participant with self-administration of medications; (c) 4 months if the attendant does not administer medications or assist the participant with medication self-administration; or (d) At a greater frequency established by the nurse monitor due to the participant's medical condition or clinical status; (6) Rendering a professional evaluation, in accordance with Regulation .13B(3) of this chapter, of a attendant's ability to carry out the participant's specific plan for attendant care; and (7) Documenting an action plan to address health and safety or medical concerns, including missed nursing supervision visits, and providing a copy of the plan to the case management agency within 5 business days. C. The services covered under this regulation may not include nursing services other than those services described in this regulation. #### Regulation .32 Covered Services — Home-Delivered Meals. *COMAR 10.09.81.32* A. Definition. “Unit of service” means one meal delivered to the participant's home, including the cost of the food, food preparation, and delivery. B. The meal shall be intended for consumption at home. C. This service may not constitute the participant's full nutritional regimen of three meals per day. D. Each meal shall: (1) Be nutritionally adequate for the participant's age based on the Recommended Dietary Allowance (RDA) or Dietary Reference Intake (DRI), as established by the Food and Nutrition Board of the National Research Council; and (2) Meet either of the following: (a) At least one-third of the RDA or DRI; or (b) Therapeutic or restrictive diet requirements ordered by the participant's physician, dietitian, or nutritionist, including any ordered nutritional supplements. E. The ICS Program's coverage under this regulation may not: (1) Result, when combined with home-delivered meals received under Title III of the Older Americans Act, in public funding for the participant's full daily nutritional regimen of three meals; or (2) Supplant payment for home-delivered meals under Title III. #### Regulation .33 Covered Services — Dietitian and Nutritionist Services. *COMAR 10.09.81.33* A. Definition. “Unit of service” means an hour of service rendered one-on-one by a qualified provider for a participant in the participant's home or the provider's office. B. Dietitian and nutritionist services shall include: (1) The provision of a nutrition care plan as part of the ICS Program multidisciplinary team process; (2) Nutrition care planning, nutrition assessment, and dietetic instruction; and (3) Services within the scope of practice of the nutritionist's or dietitian's license, as defined by: (a) Health Occupations Article, Title 5, Annotated Code of Maryland; and (b) Regulations under COMAR 10.56 for the Board of Dietetic Practice. C. Dietitian and nutritionist services may not include services rendered on a group basis or in a classroom setting. D. The services shall be: (1) Covered if the participant's medical condition requires the judgment, knowledge, and skills of a licensed nutritionist or licensed dietitian; (2) Targeted to the individualized needs of the participant, rather than being of general interest; (3) Sensitive to the educational background, culture, religion, eating habits, preferences, and general environment of the participant; and (4) Specified in the participant's plan of service as necessary to: (a) Ensure the participant's health and safety; and (b) Prevent the participant's institutionalization or hospitalization. #### Regulation .34 Covered Services — Behavior Consultation Services. *COMAR 10.09.81.34* A. Definition. “Unit of service” means an hour of service rendered by a qualified individual during a home visit to a participant, not including: (1) The time spent on related activities before or after the home visit; or (2) The time spent on supervisory or consultative services to the provider. B. A provider may bill for the length of a home visit to a participant, upon completion of the services specified in §D of this regulation. C. Behavior consultation services may be preauthorized by a participant's plan of care as necessary and appropriate when: (1) A participant's behavior is: (a) Disruptive; (b) Potentially dangerous to the participant's or another person's health and functioning; or (c) Placing the participant at risk of institutionalization due to health and safety concerns; and (2) Advice is needed as to how to manage the disruptive behavior of a participant. D. Behavior consultation services include a: (1) Home visit by an individual qualified to render services to: (a) Evaluate a participant's acute behavior change; (b) Assess the situation; (c) Determine the contributing factors; and (d) Recommend interventions and treatments; (2) Written report prepared for review by the case manager and the assisted living services provider or the participant's family, which assesses the situation and makes recommendations; and (3) Verbal review of the report with the case manager and the assisted living services provider or the participant's family to discuss: (a) The report's findings and recommendations; and (b) A course of action, including any related needed medical interventions. #### Regulation .35 Covered Services — Medical Day Care. *COMAR 10.09.81.35* A. Definition. “Unit of service” means a day of service rendered by a qualified provider to a participant in accordance with COMAR 10.09.07. B. The ICS Program reimburses for a day of care which includes the following services: (1) Health care services supervised by the director, medical director, or health director, which emphasize primary prevention, early diagnosis and treatment, rehabilitation and continuity of care, including the following: (a) Participation in the development of the individual participant's plan of care; (b) Participation in the determination of the participant's medical, psychosocial, and functional status; (c) Consultation with the participant's personal physician; and (d) Consultation with staff regarding a participant's condition and health care needs; (2) Nursing services performed by a registered nurse or by a licensed practical nurse under the supervision of a registered nurse which include: (a) The evaluation of the needs of the participants for nursing care; (b) The supervision of any nursing staff; (c) Preventive and maintenance services; (d) Observation and monitoring of participant's condition; (e) Rehabilitative services; (f) The teaching and training activities in appropriate self-care techniques; (g) The supervision of medication normally self-administered; (h) The provision of health education; (i) Discharge planning; and (j) Nursing services that may be delegated to other staff in accordance with COMAR 10.27.11; (3) Physical therapy services, performed by or under supervision of a licensed physical therapist, that: (a) Are of a diagnostic, rehabilitative, therapeutic, or maintenance nature, and are provided based on the assessment by the physician that the: (i) Participant will improve significantly in a reasonable and generally predictable period of time; or (ii) Services are necessary for the establishment of a safe and effective maintenance program required in connection with a specific disease state; (b) Are directly related to the physician's written plan of care which specifies: (i) Part or parts to be treated; (ii) Type of modalities or treatments to be rendered; (iii) Expected results of physical therapy treatments; and (iv) Frequency and duration of treatment; (c) The complexity of the services, or the condition of a participant, require the judgment, knowledge, and skills of a licensed physical therapist; and (d) The services are considered to be an effective treatment according to accepted standards of medical practice; (4) Occupational therapy services, performed by an occupational therapist, that meet the following conditions: (a) The treatment requires the special skills of an occupational therapist; (b) The services are directly related to the physician's written plan of care which specifies the: (i) Treatment to be rendered; (ii) Frequency and duration of the treatment; and (iii) Expected results; (c) The treatment is provided with the expectation that there will be a significant practical improvement in a participant's level of functioning within a reasonable period of time; and (d) The services fall within one or more of the following categories: (i) Evaluation and reevaluation of a participant's level of functioning by administering diagnostic and prognostic tests; (ii) Selection and teaching of task-oriented therapeutic activities designed to restore physical function; (iii) Teaching of compensatory techniques to improve the level of independence in the activities of daily living; (iv) Training in the use of supportive and adaptive equipment, and assistive devices required for independent performance according to COMAR 10.09.12; and (v) Improvement of mobility skills; (5) Personal care services which include assistance with activities of daily living; (6) Nutrition services which include the following: (a) Meals and snacks as specified under COMAR 10.12.04.19; (b) Therapeutic diets as specified under COMAR 10.12.04.19; and (c) Dietary counseling and education; (7) Social work services performed by a licensed, certified social worker, or licensed social work associate which include: (a) Screening and interviewing, or assisting designated staff with screening and interviewing prospective participants to determine the general appropriateness of the individual for the full assessment process for medical day care services; (b) Ongoing services to include: (i) Identifying the emotional and social needs of participants during the rendering of medical day care services; (ii) Maintaining linkages with community support resources for the participant including relatives, friends, and other care providers; (iii) Counseling to improve the participant's response to the plan of care, chronic condition, and prospects for recovery or stabilization, but does not include diagnosing or treating mental disorders; (iv) Counseling a participant and a participant's family in the availability and utilization of public and private community services, referral to, and coordination of these services; (v) Assisting participants in obtaining health care services that are not available through the medical day care center, such as vision care, podiatry, or medical equipment; (vi) Counseling participants to assist with acclimation to the medical day care center's services and to promote active involvement in their plan of care; (vii) Coordinating and implementing group and family counseling in conjunction with plan of care goals; (viii) Writing notes in the participant's records that reflect the social work activities performed; and (ix) Participating in the multidisciplinary team meetings; and (c) Discharge planning and referral services including: (i) Written procedures for discharge, referral, and follow-up; (ii) A discharge summary with post discharge goals; (iii) Recommendations for continuing care; and (iv) Referral to appropriate community service agencies and health care providers to facilitate the participant's return to more independent living; (8) Activity programs in accordance with COMAR 10.12.04.14C; and (9) Transportation services that: (a) Are provided or arranged for a participant by the medical day care staff; (b) Maximize the following types of transportation services: (i) Walking, for a person who lives within walking distance of the medical day care center and who is sufficiently mobile; (ii) Family-supplied transportation provided by friends, neighbors, or volunteers; and (iii) Public transportation services; (c) Are procured by the provider after options described in §B(9)(b) of this regulation have been exhausted; (d) Are the responsibility of the provider to: (i) Arrange contractual agreements with transportation providers to meet the transportation needs of the participants; and (ii) Group participants, where possible, in the same taxi, van or specially equipped vehicles, to minimize the cost of transportation; (e) Are provided in accordance with a primary transportation plan and a back-up plan; (f) Are documented, indicating the type of transportation used by each participant; (g) Are scheduled to ensure that a participant's one-way transit time does not exceed 1 hour as specified under COMAR 10.12.04.27; and (h) Are included in the day of care for: (i) Trips and outings which are part of the activities program; and (ii) A participant's medical appointment escorted by center staff. C. The day care service shall be: (1) Authorized in the participant's plan of service; (2) Medically necessary; (3) Adequately described in progress notes in the participant's medical record, signed and dated by the individual providing care; and (4) Provided to participants documented to be present at the medical day care center a minimum of 4 hours a day. #### Regulation .36 Covered Services — Senior Center Plus. *COMAR 10.09.81.36* A. Definition. “Unit of service” means a day of attendance by a participant for at least 4 hours, not including transportation to and from the center. B. Senior Center Plus services include a program of structured group recreational activities, supervised care, assistance with activities of daily living and instrumental activities of daily living, and socialization provided in an out-of-home, outpatient setting. Social and recreational activities designed for elderly and disabled individuals, and one nutritious meal shall be provided by the center. C. This program is designed to promote the participants' optimal functioning and to improve their orientation and cognitive ability. D. A provider may choose to provide transportation to and from the site of the Senior Center Plus services. These transportation services: (1) May not be included in the provider's daily rate negotiated with the Maryland Department of Aging; and (2) Shall be reimbursed through some other funding source for transportation services. E. Senior Center Plus does not cover: (1) Transportation; (2) Direct health care; or (3) A full regimen of three meals per day. #### Regulation .37 Covered Services — Assisted Living Facility. *COMAR 10.09.81.37* A. Definition. “Unit of service” means a day of service and does not include days that the participant was not residing in the provider's assisted living facility, meaning that the participant: (1) Had not yet moved into the facility; (2) Had moved out of the facility; (3) Was an inpatient at a hospital, nursing facility, or other medical institution for one or more nights; or (4) Was absent from the provider's facility for more than 7 nights during a calendar month at the participant's choice for personal reasons, such as to visit family or take a vacation. B. Assisted living services shall include the provision of: (1) A structured, supportive environment in a home-like setting; (2) Personal care and chore services including: (a) Assisting the participant, as necessary, with performing activities of daily living and instrumental activities of daily living, including cuing the participant to perform these activities; (b) Routine housekeeping, laundry, household care, and chore services needed to maintain the facility as a clean, sanitary, and safe environment; and (c) Menu planning, food shopping, and meal preparation and serving; (3) Basic personal hygiene supplies, including but not limited to: (a) Soap; (b) Bathroom tissue; (c) Paper towels; (d) Toothpaste; (e) Toothbrush; and (f) Shampoo; (4) 24-hour supervision of participants to assure health and safety; (5) Assistance with medication administration, in accordance with COMAR 10.27.11 and COMAR 10.07.14; (6) Recreational and social activities; (7) Reminding the participant of medical appointments; (8) Assistance with transportation arrangements to Program and other needed services; (9) Conferring with the participant's case manager about the participant's status and service needs; (10) Assisting the participant in accessing needed medical or mental health services in emergency situations; and (11) Other services specified for assisted living programs in COMAR 10.07.14. C. Assisted living services shall reflect the participants' individualized needs and preferences. D. Assisted living services reimbursed under this chapter may not include room and board. #### Regulation .38 Conditions for Reimbursement. *COMAR 10.09.81.38* The Maryland Medical Assistance Program shall reimburse for the services specified in Regulations .22 — .37 of this chapter, if the service: A. Is recommended in the applicant’s or participant's plan of service as necessary in order to: (1) Prevent admission to a nursing facility; (2) Safely deinstitutionalize the individual from a nursing facility into the community; or (3) Assure the participant’s health and safety in the community; B. Has been preapproved by the Department in the participant's plan of service; C. Is provided to an enrolled participant who meets the qualifications for eligibility specified in Regulation .03 of this chapter; D. Is appropriate, relative to other community-based services; E. Is cost-neutral for the ICS Program after receipt of the monthly assessment fee and by calculating, on an annualized basis, the cost of services covered under this chapter and other State Plan services that are not covered for nursing facility residents; and F. Is provided by a Medicaid provider of ICS Program services who meets the appropriate conditions for participation under this chapter. #### Regulation .39 Limitations. *COMAR 10.09.81.39* A. Reimbursement may be made by the Maryland Medical Assistance Program only if the requirements of this chapter are met. B. The total reimbursement by the Maryland Medical Assistance Program for environmental accessibility adaptations and assistive technology combined is limited to the amount specified at Regulation .40C(4)(f)(ii) or (h)(ii) of this chapter during the participant’s annual plan of service period, with exceptions allowed at the Department's discretion in the following circumstances: (1) The amount exceeds the limit, but will allow the individual to return home from a nursing facility or avoid immediate placement in a nursing facility, and does not exceed the participant's cost neutrality under Regulation .38E of this chapter; or (2) Expenditures in excess of the annual limit will reduce the participant's ongoing Medicaid cost of care significantly without exceeding the participant's cost neutrality. C. Reimbursement for services or equipment estimated to cost more than the amount specified in Regulation .40C(4)(g)(ii) of this chapter shall be preapproved by the Department based on at least two cost estimates obtained from prospective vendors. D. Reimbursement by the Maryland Medical Assistance Program for environmental accessibility adaptations covered under Regulation .27 of this chapter is limited to modifying two residences of the participant every 3 consecutive years. E. Excluded from coverage under Regulation .27 of this chapter are adaptations or improvements to the home which: (1) Are of general utility, such as carpeting, roof repair, and central air conditioning; (2) Are not of direct medical or remedial benefit to the participant; or (3) Add to the home's total square footage. F. Reimbursement by the Maryland Medical Assistance Program for personal emergency response systems covered under Regulation .28 of this chapter may only be allowed for participants who: (1) Are alone for significant parts of the day; (2) Have no regular caregiver for extended parts of the day; and (3) Would otherwise require extensive routine supervision to ensure the participant's health and safety. G. The Maryland Medical Assistance Program may not reimburse for attendant care services provided under this chapter if: (1) On the same date of service, a participant also received personal care services under COMAR 10.09.20; or (2) Rendered for more than 23 hours for a participant on the same date of service. H. Reimbursement for the following services shall be limited to 8 hours per service per date of service: (1) Family training; (2) Participant training; or (3) Nursing supervision. I. The total amount of reimbursement by the Maryland Medical Assistance Program for transition services is limited to a one-time expense of $3,000 per participant, with exceptions allowed at the Department's discretion. #### Regulation .40 Payment Procedures — General. *COMAR 10.09.81.40* A. Request for Payment. (1) An approved provider shall: (a) Submit a request for payment for the services covered under this chapter according to procedures set forth in COMAR 10.09.36.04; and (b) Include the following information on the request: (i) Date or dates of service; (ii) Participant's name and Medical Assistance number; (iii) Provider's name, location, and identification number; (iv) Nature, procedure code or codes, and unit or units of the covered services provided; and (v) Amount of reimbursement requested. (2) The provider shall submit a request for payment in a manner approved by the Maryland Medical Assistance Program. (3) Participant-employed attendants shall submit a request for payment to a designated fiscal intermediary who shall: (a) Submit bills to the Department; (b) Withhold appropriate taxes; and (c) Remit reimbursement to the provider for services rendered. (4) A request for payment shall include all units of service rendered, as defined in Regulations .22 — .37 of this chapter, during a given time period for a participant. (5) Except as specified in §A(3) of this regulation, the provider shall bill the Department, or its authorized agent, in accordance with the payment methodology specified in Regulation .41 of this chapter for services approved by the Department. B. Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06. C. Payments. (1) Payments for services rendered to a participant shall be made: (a) Directly to a qualified provider; or (b) To a designated fiscal intermediary for distribution to participant-employed attendants. (2) A provider shall be paid the lesser of: (a) The provider’s customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rate established in Regulation .41 of this chapter. (3) Payment by the Department for the services covered under this chapter: (a) Shall be considered as payment in full; and (b) May not supplement or be supplemented by payment from other sources, such as the participant, family, a public program, or private agency. D. The ICS Program’s rates as specified in Regulation .41A — C, E, I — M, O, and P of this chapter shall increase on July 1 of each year beginning July 1, 2012, subject to the limitations of the State budget, by the lesser of: (1) 2.5 percent; or (2) The change from March to March in the medical care component of the Consumer Price Index for all urban consumers (CPI-U) for the Washington-Baltimore area. #### Regulation .41 Payment Procedures — Rates. *COMAR 10.09.81.41* A. To receive payment as a provider of services covered under Regulations .23, .24, and .33—.37 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department's billing manual. B. Billing time limitations for the services covered under this chapter are set forth in COMAR 10.09.36.06. C. Payments. (1) Payments shall be made directly to a qualified provider. (2) A provider shall be paid the lesser of: (a) The provider's customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rates established in §D of this regulation. D. Rates. (1) For dates of service beginning July 1, 2024, fees per unit of service shall be as follows: (a) Assisted Living Level II, No Medical Day Care—reimbursed at the maximum rate of $90.74 per day; (b) Assisted Living Level III, No Medical Day Care—reimbursed at the maximum rate of $114.51 per day; (c) Assisted Living Level II, Medical Day Care—reimbursed at the maximum rate of $68.09 per day; (d) Assisted Living Level III, Medical Day Care—reimbursed at the maximum rate of $85.86 per day; (e) Behavioral Consultation—reimbursed at the maximum rate of $99.25 per hour; (f) Case Management—Administrative—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; (g) Case Management—Comprehensive—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; (h) Case Management—Ongoing—reimbursed at the maximum rate of $93.06 per hour or $23.2645 per 15-minute unit; (i) Dietitian and Nutritionist Services—reimbursed at the maximum rate of $99.25 per hour; (j) Family 1/1 Training—reimbursed at the maximum rate of $99.25 per hour; (k) Medical Day Care Services—reimbursed at the maximum rate of $116.59 per day; and (l) Senior Center Plus—reimbursed at the maximum rate of $72.19 per day. (2) The ICS Program’s rates for covered services under Regulations .23, .24, and .33—.37 of this chapter shall be adjusted subject to the limitations of the State budget. #### Regulation .42 Recovery and Reimbursement. *COMAR 10.09.81.42* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .43 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.81.43* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .44 Appeal Procedures for Providers. *COMAR 10.09.81.44* Appeal procedures for providers are those set forth in COMAR 10.09.36.09. #### Regulation .45 Appeal Procedures for Applicants and Participants. *COMAR 10.09.81.45* Appeal procedures for applicants and participants are those set forth in COMAR 10.09.24.13 and 10.01.04. #### Regulation .46 Interpretive Regulation. *COMAR 10.09.81.46* State regulations are interpreted as set forth in COMAR 10.09.36.10. ### Chapter 82 — Provider-Based Outpatient Oncology Facilities **Authority:** Health-General Article, §§2-104, 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: September 17, 2012 (39:18 Md. R. 1196) **Administrative History:** Regulation .06B amended effective July 4, 2016 (43:13 Md. R. 712) #### Regulation .01 Definitions. *COMAR 10.09.82.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (2) “Healthcare Common Procedure Coding System (HCPCS)” means a set of health care procedure codes based on the American Medical Association's Current Procedural Terminology (CPT). (3) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (4) “Medicare-certified facility” means a facility which is certified for Medicare by the regional office of the Centers for Medicare and Medicaid Services (CMS). (5) “Provider-based outpatient oncology facility” means an outpatient facility that is: (a) Owned by a hospital; (b) Located off-site from the hospital; and (c) Not regulated by the Health Services Cost Review Commission (HSCRC). (6) “Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. #### Regulation .02 License Requirements. *COMAR 10.09.82.02* In order to participate in the Program, the provider shall: A. Meet all requirements as set forth in COMAR 10.09.36.02; and B. Ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed and if located: (1) In Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or (2) Out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. #### Regulation .03 Conditions for Participation. *COMAR 10.09.82.03* A. To participate in the Program, a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. Specific requirements for participation with the Department as a provider-based outpatient oncology facility require that the provider shall: (1) Be a Medicare-certified facility; (2) Have clearly defined, written patient care policies; and (3) Maintain adequate documentation of each recipient visit as part of the plan of care, which at a minimum, shall include: (a) Date of service; (b) A description of the service provided; and (c) A legible signature and printed or typed name of the professional providing care, with the appropriate title. #### Regulation .04 Covered Services. *COMAR 10.09.82.04* The Program covers the following services when medically necessary: A. Radiation therapy; B. Chemotherapy; C. IV Infusion; D. Blood transfusions; E. Medical supplies; F. Drugs; and G. Bone marrow biopsies. #### Regulation .05 Limitations. *COMAR 10.09.82.05* The following services are not covered: A. Any service or treatment that is not medically necessary; B. Experimental or investigational services; C. Services that are specifically included as part of another service; and D. Professional fees provided by physicians billed separately from the facility’s charges. #### Regulation .06 Payment Procedures. *COMAR 10.09.82.06* A. General policies for payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04. B. Specific Payment Procedures for a Provider-Based Outpatient Oncology Facility. (1) The provider shall submit a request for payment on the form designated by the Department for dates of service on or after July 1, 2012. (2) Except for drugs which shall be billed to the Program using the National Drug Code (NDC) and appropriate the HCPCS, the Department shall reimburse the facility at an amount that is equal to 80 percent of the Medicare rate of reimbursement. (3) The Department shall authorize payment on Medicare claims if: (a) The provider accepts Medicare; (b) Medicare makes direct payment to the provider; and (c) Medicare has determined the services are medically necessary. (4) The provider may not bill the Program or the recipient for: (a) Completion of forms or reports; (b) Broken or missed appointments; or (c) Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. (5) The Program makes no direct payments to recipients. (6) The billing time limitations are set forth in COMAR 10.09.36. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.82.07* A. If the recipient has insurance, or if any other person is obligated either legally or contractually to pay for or to reimburse for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Department. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the claim. If payment is made by both the Program and by the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.82.08* General policies governing cause for suspension or removal and imposing sanctions that are applicable to all providers are set forth in COMAR 10.09.36.08. #### Regulation .09 Appeal Procedures. *COMAR 10.09.82.09* General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.82.10* General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10. ### Chapter 83 — Third Party Liability **Authority:** Health-General Article, §§2-104(b), 15-103, 15-105, and 15-120—15-121.3, Annotated Code of Maryland **Administrative History:** Effective date: June 24, 2013 (40:12 Md. R. 1042) #### Regulation .01 Definitions. *COMAR 10.09.83.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Claim” means a demand for payment, whether or not the right is reduced to judgment, liquidated, unliquidated, fixed, contingent, matured, unmatured, disputed, undisputed, legal, equitable, secured or unsecured. (2) “Department” means the Maryland Department of Health, the single State agency designated to administer the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (3) “Program” means the Maryland Medical Assistance Program. (4) “Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or certified to provide health care services for recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number. (5) “Recipient” means: (a) An individual who is certified as eligible for, and is receiving, Program benefits; (b) An individual who was certified as eligible for and received Program benefits; or (c) The successor in interest of a person identified in §B(6)(a) or (b) of this regulation. (6) “Third party” means any individual, entity or program that is or may be liable to pay all or part of the expenditures for Program benefits. #### Regulation .02 Program’s Right of Subrogation. *COMAR 10.09.83.02* A. The Department may not pay medical claims that are payable by a third party. B. The Department is assigned any and all rights to payments by any third party that result from medical care received by the recipient, together with the rights of any other individuals eligible for Program benefits for whom the recipient can make assignment. This assignment shall be effective to the extent of the amount of medical assistance actually paid by the Program. C. If a recipient has a cause of action against a third party, including a claim under Insurance Article, §19-509 or 19-510, Annotated Code of Maryland, the Department shall be subrogated to that cause of action to the extent of any payments made by the Department on behalf of the recipient that result from the occurrence that gave rise to the cause of action. D. The Department’s subrogation claim shall be limited to that portion of the claim that represents compensation for the medical expenses paid by the Program until the date of an award, settlement or judgment. E. Judicial Allocation of Medical Expenses from an Award or Settlement. (1) A recipient may not agree, in settlement of the recipient’s cause of action, to an allocation of medical expenses less than the amounts set forth in §F of this regulation, without prior approval of the Department. (2) If an action decided by the court does not determine the allocation of medical expenses in such action, the allocation shall be determined in accordance with §F of this regulation. (3) Provided that the Department is provided at least 10 days advance written notice of any hearing at which the allocation of medical expenses shall be heard, the Department shall defer to the court’s determination of the allocation of medical expenses. F. The Department’s Recovery in Subrogation Claims. (1) Except as provided in §§F(2) — (4) of this regulation, in satisfaction of the Department’s subrogation claim, the Department shall recover the lesser of: (a) The full amount of past medical costs paid by the Program; or (b) 50 percent of the judgment, award or settlement less attorney fees, litigation costs, and other deductions required by law. (2) For the benefit of the recipient, the Department’s recovery in subrogation claims as provided in §F(1) of this regulation shall be reduced by one-third, for the amount of the attorney’s fees incurred by the recipient in bringing the case, unless the Department files a petition to intervene in a case in which it has a subrogation interest, is independently represented by counsel and has been provided the notice required by §E(3) of this regulation. (3) The Department shall provide the recipient written notice under COMAR 10.01.04.03 of the amount of the subrogation claim it proposes to recover as provided in §§F(1)—(2) of this regulation and of the recipient’s right to request a fair hearing to present evidence of a different allocation of medical expenses. If the recipient files a request for a hearing, the recipient shall bear the burden of proof and the hearing shall be governed by COMAR 10.01.04. Unless the recipient files a timely request for a hearing within 30 days of receipt of the written notice, the Department shall recover the amount of the subrogation claim set forth in the written notice to the recipient. (4) If the amount of money actually collected by the recipient is less than the amount of the judgment or award because available insurance coverage is less than the amount of the judgment or award, the Department’s recovery as calculated in §F(1) of this regulation shall be proportionally reduced by the same percentage as is the amount actually collected compared to the amount of the judgment or award. G. Unless ordered by a court, the Department may not be required to join, intervene, or otherwise become a party to the cause of action against a third party to maintain the Department’s subrogation right under §C of this regulation. H. An action brought under this regulation is not exclusive and is independent of and in addition to any right, remedy, or cause of action available to the State, the Department, other State agencies, or a Program recipient or other individual. I. The Department may enter into contracts for the collection of medical expenses already paid by the Program from potential third parties. The Department may pay, from the funds recovered by the contractor, amounts owed to the federal government as the Department’s share of the Program paid claim, and the costs of collecting the funds. J. The Department may assign the Department’s rights of subrogation to a managed care organization and shall provide notice of the assignment to the recipient or the recipient’s attorney. K. The Department may compromise or settle and release the Department’s subrogation claim if, in the Department’s judgment, collection of the claim will cause substantial hardship to the: (1) Recipient; or (2) Surviving dependents of a deceased recipient in a wrongful death action. #### Regulation .03 Recipient Responsibility. *COMAR 10.09.83.03* A. A recipient shall cooperate with and assist the Department in identifying and providing information concerning third parties who may be liable to pay for care and services received by the recipient under the Program. B. A recipient is required to assist and cooperate fully with the Department in the Department’s efforts to secure the Department’s rights in Regulation .02 of this chapter, including but not limited to: (1) Notifying the Program’s Division of Recoveries and Financial Services in writing within 10 days of filing suit or commencing an action against a third party; (2) Notifying the Program’s Division of Recoveries and Financial Services in writing before negotiating or entering a settlement with a third party; (3) Subject to Regulation .05 of this chapter, paying to the Program within 30 days all funds received from a third party to the extent necessary to satisfy the subrogation rights of the Department; (4) Disclosing information regarding health insurance or other third party resources when applying for Program benefits; (5) Notifying providers of health and casualty coverage and other third party resources when requesting medical care; (6) Notifying the Program of any health insurance obtained after becoming eligible for Medicaid; (7) Notifying the Program’s Division of Recoveries and Financial Services of any casualty or liability insurance that may cover medical treatment received due to an injury; and (8) Executing and delivering to the Program such documents as reasonably requested by the Program to pursue the Department’s subrogation claim. C. As a condition of medical assistance eligibility, a person who applies for Program benefits shall, at the time of application: (1) Assign to the Department the applicant's rights of payment for care and services from a third party to the extent the Department has paid for care and services; (2) Cooperate with and assist the Department in identifying and providing information concerning third parties who may be liable to pay for care and services received by the recipient under the Program; and (3) Agree to apply for all other available third party resources that may be used to: (a) Provide or pay for the cost of care or services received by the recipient; or (b) Finance reimbursement to the State for the cost of care or services received by the recipient. D. Nothing in this regulation shall require a recipient to file a civil or other action for the purpose of reimbursing the State for the cost of care or services. If a recipient fails or refuses to commence a civil or other action to enforce the legal liability of a third party, the Department may commence an independent action, after notice to the recipient, to recover all medical costs to which the Department is entitled. In any such action by the Department, the recipient in interest may be joined as a party. E. Failure of the applicant or recipient to cooperate with the Program to secure the Department’s rights to subrogation and assignment may result in the denial or termination of the recipient’s Program eligibility. Recipients terminated under this regulation shall be notified in writing of the proposed Program action and afforded the opportunity for a fair hearing under COMAR 10.01.04. #### Regulation .04 Notice to the Department. *COMAR 10.09.83.04* A. An attorney representing a recipient in a cause of action that gives rise to the Department’s right of subrogation under Regulation .02 of this chapter shall notify the Program’s Division of Recoveries and Financial Services in writing before: (1) Filing a claim; (2) Commencing an action; or (3) Negotiating a settlement. B. The notice required under §A of this regulation shall include submission of the following information: (1) The recipient's name, Social Security Number, date of birth, last known address, and telephone number; (2) The name of any person against whom the recipient is making a claim; (3) The identification of each potentially liable third party, including that party's name, last known address, and telephone number; (4) The name of any insurer of any person against whom the recipient is making a claim, if known; (5) The date of the injury or illness giving rise to the claim; (6) A short statement identifying the nature of the recipient’s claim or the terms of any settlement, judgment or award; (7) Copies of the pleadings and other papers related to the action or claim; and (8) A valid release of the confidentiality of the recipient’s medical records from the date of the injury until the date of the notice. C. In any action or claim by a recipient to recover damages for an injury or illness that has resulted in the Department providing or paying for Program benefits, an attorney who represents a recipient shall give the Program’s Division of Recoveries and Financial Services written notice: (1) Not later than 30 calendar days after any judgment or award in such action or claim; or (2) Before the resolution of the cause of action or claim. D. In addition to the notices required in §§A and C of this regulation, an attorney required to give notice under §A or C of this regulation shall give the Program’s Division of Recoveries and Financial Services additional written notice not later than 30 calendar days after judgment, award, or settlement of the action or claim stating the amount and terms of any judgment, award, or settlement of the action or claim. E. Upon receiving the notice required pursuant to §A of this regulation, the Department shall, within 3 business days, acknowledge in writing its claim to the recipient or the attorney of the recipient and to the third party. The Department shall provide the amount of the claim and an itemized list of charges within 15 business days pursuant to Regulation .06 of this chapter. Nothing herein shall prevent the Department from thereafter updating the amount of the claim and itemized list of charges within a reasonable time after the recipient’s provider notifies the Department of additional charges. F. Upon receiving the notice required pursuant to §A of this regulation, the Department shall, within 3 business days, advise the recipient or the attorney of the recipient and the third party, in writing, whether the recipient is: (1) A Medicaid recipient; (2) A member of a Medicaid Managed Care Organization (MCO); or (3) Not a Medicaid recipient. G. Under Regulation .06 of this chapter, the Department shall provide the amount of the claim and an itemized list of charges within 15 business days of receipt of the notice required under §A of this regulation. Nothing in this regulation shall prevent the Department from updating the amount of the claim and itemized list of charges within a reasonable time after the recipient’s provider notifies the Department of additional charges. #### Regulation .05 Judgment, Award, or Settlement of a Medical Assistance Claim. *COMAR 10.09.83.05* A. Except as provided in §§B—E of this regulation, a third party shall have no further liability if it settles or compromises a dispute in good faith and without knowledge that the individual is a recipient of Program benefits. B. A recipient, or the recipient’s attorney, guardian, or personal representative, who receives money as a result of a judgment, award, or settlement of an action or claim in which the Department has a subrogation claim shall: (1) Deduct applicable attorney fees and litigation costs from the total judgment, award, or settlement; (2) Subject to §C of this regulation, hold and forward to the Department the remainder of the judgment, award, or settlement for the benefit of the Department to the extent required for the Department’s subrogation claim. C. A recipient shall first repay the Department for costs of past Program services provided to the recipient related to that action or claim before placing any money received from a judgment, award, or settlement into any special needs trust, pooled trust, or pooled trust sub-account, or otherwise distributing the recovered funds to or for the benefit of the recipient. If the recipient and the Department disagree about the amount of the Department’s subrogation right under Regulation .02 of this chapter, the recipient may place the undisputed portion of the judgment, award or settlement into any special needs trust, pooled trust, or pooled trust sub-account, or otherwise distribute the undisputed portion to or for the benefit of the recipient, and the disputed portion of the judgment, award or settlement into an escrow account pending resolution of the disagreement. D. The Department may only discharge a claim under Regulation .06 of this chapter if the discharge complies with federal law. E. Liability to the Department. (1) Except as otherwise provided in §E(3) of this regulation, a person who, after written notice of the Department’s subrogation claim under Regulation .04F of this chapter, disposes of money as a result of a judgment, award, or settlement of an action or claim in violation of §B or C of this regulation, without the written approval of the Department, shall be liable to the Department for any amount that, because of the disposition, is not recoverable by the Department. (2) Except as otherwise provided in §E(3) of this regulation, any person who fails to comply with the notice requirements of Regulation .04 of this chapter is liable to the Department for: (a) The total amount of the Department’s claim created pursuant to Regulation .06 of this chapter; and (b) Any attorney’s fees and litigation expenses incurred by the Department in enforcing the Department’s subrogation rights. (3) A person is not liable to the Department under §E(1) or (2) of this regulation if a court determines that there was good cause for: (a) Disposing of the money in violation of §B or C of this regulation; or (b) Failing to comply with the notice requirements of Regulation .04 of this chapter. #### Regulation .06 Program Claim. *COMAR 10.09.83.06* A. In a case where the Department is subrogated to the rights of the recipient, the Department has a claim to the proceeds of the recovery from the persons liable, whether the proceeds of the recovery are by way of judgment, settlement, or otherwise and shall, to the extent permitted by federal law, be satisfied in full. B. The claim is in the amount of all Program benefits paid minus any deductions required by law. C. The claim is effective when: (1) Filed with a court of competent jurisdiction in the State; and (2) Notice of filing of the claim is served by the Department upon the third party, personally or by registered, certified, or insured mail, return receipt requested. #### Regulation .07 Conflict with Federal Requirements. *COMAR 10.09.83.07* If any provision of this chapter related to subrogation, assignment, or lien conflicts with federal law concerning the Program or receipt of federal funds to finance the Program, the provision does not apply to the extent of the conflict. ### Chapter 84 — Community First Choice **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: March 17, 2014 (41:5 Md. R. 343) **Administrative History:** Regulation .01 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .02B amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449); February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .03 amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .04 amended effective June 8, 2015 (42:11 Md. R. 724) **Administrative History:** Regulation .04A, B amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .05A amended effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .05A, B amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .05A, C amended effective June 8, 2015 (42:11 Md. R. 724) **Administrative History:** Regulation .06 amended effective June 8, 2015 (42:11 Md. R. 724); November 9, 2015 (42:22 Md. R. 1377); April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .06A amended effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .07 amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449); February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .10D adopted effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .13 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .14A amended effective January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .15 amended effective January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .15B amended effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .15B, C amended effective June 8, 2015 (42:11 Md. R. 724); April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .16 amended effective January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .17A amended effective January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .18 amended effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .18E adopted effective January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .19 amended effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .19A amended effective January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .20 amended effective April 11, 2016 (43:7 Md. R. 449); January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .20B amended effective June 8, 2015 (42:11 Md. R. 724) **Administrative History:** Regulation .22B amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .23 amended effective April 11, 2016 (43:7 Md. R. 449) **Administrative History:** Regulation .23B amended effective January 30, 2017 (44:2 Md. R. 85) **Administrative History:** Regulation .23C amended effective June 8, 2015 (42:11 Md. R. 724); February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .23E, F adopted effective February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .23D adopted effective November 9, 2015 (42:22 Md. R. 1377) **Administrative History:** Regulation .24 amended effective April 11, 2016 (43:7 Md. R. 449); January 30, 2017 (44:2 Md. R. 85); February 12, 2018 (45:3 Md. R. 156) **Administrative History:** Regulation .24A, E amended effective June 8, 2015 (42:11 Md. R. 724) **Administrative History:** Regulation .24F amended effective May 20, 2019 (46:10 Md. R. 486) **Administrative History:** Regulation .27 amended effective June 8, 2015 (42:11 Md. R. 724) #### Regulation .01 Purpose. *COMAR 10.09.84.01* The purpose of Community First Choice is to provide certain home and community-based services and supports, as an alternative to institutional placements, to individuals who have been determined to require an institutional level of care. #### Regulation .02 Definitions. *COMAR 10.09.84.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living (ADLs)” means tasks or activities that include, but are not limited to: (a) Bathing and completing personal hygiene routines; (b) Dressing and changing clothes; (c) Eating; (d) Mobility, including: (i) Transferring from a bed, chair, or other structure; (ii) Moving, turning, and positioning the body while in bed or in a wheelchair; and (iii) Moving about indoors or outdoors; and (e) Toileting, including: (i) Bladder and bowel requirements; (ii) Routines associated with the achievement or maintenance of continence; and (iii) Incontinence care. (2) “Applicant” means an individual who is applying to receive services under this chapter. (3) “Assistance” means that another individual: (a) Physically performs the activity for the participant; (b) Physically helps the participant to perform the activity; (c) Monitors the participant’s performance of the activity in order to ensure health and safety; or (d) Cues or encourages the participant to perform the activity. (4) “Case management services” means services which assist an applicant or a participant in gaining access to waiver and other covered Medicaid services. (5) “Case manager” means a person performing case management services under a waiver program and acting in the role of the supports planner. (6) “Certified medication technician (CMT)” means an individual, regardless of title, who: (a) Completes a course in medication administration approved by the Maryland Board of Nursing; (b) Is certified by the Maryland Board of Nursing under COMAR 10.39.04; and (c) Performs medication administration tasks delegated by a nurse in accordance with COMAR 10.27.11. (7) “Certified nursing assistant (CNA)” means an individual, regardless of title, who: (a) Is certified by the Maryland Board of Nursing under COMAR 10.39.01; and (b) Routinely performs delegated nursing tasks delegated by a nurse in accordance with COMAR 10.27.11. (8) “Community First Choice” means the Medicaid home and community-based services program implemented under this chapter in accordance with the application and any amendments to it submitted by the Department and approved by the Secretary of Health and Human Services, which authorizes the provision of certain home and community-based services under the Maryland Medical Assistance Program. (9) Community Setting. (a) “Community setting” means the area, district, locality, neighborhood, or vicinity where a group of people live which provides participants with opportunities to: (i) Seek employment and work in competitive integrated settings; (ii) Engage in community life; (iii) Control personal resources; and (iv) Receive services. (b) “Community setting” does not mean: (i) Hospitals; (ii) Nursing facilities; (iii) Institutions for mental diseases; (iv) Intermediate care facilities for individuals with intellectual disabilities; or (v) Other institutions. (10) “Conflicts of interest” means real or seeming incompatibility between one’s private interests and one’s public or fiduciary duties. (11) “Delegated nursing functions” means nursing services provided to a participant by an enrolled personal assistance worker under the supervision of a: (a) Registered nurse in accordance with COMAR 10.27.11; or (b) Nurse practitioner in accordance with COMAR 10.27.07. (12) “Department” means the Maryland Department of Health, or its authorized agent acting on behalf of the Department. (13) Home. (a) “Home” means the participant’s place of residence in a community setting. (b) “Home” does not mean: (i) An assisted living program as defined in COMAR 10.07.14; (ii) A residential rehabilitation program licensed as a therapeutic group home under COMAR 10.21.07; (iii) An alternative living unit, group home, or individual family care home as defined in COMAR 10.22.01; (iv) Community-based residential facilities for individuals with intellectual or developmental disabilities licensed under COMAR 10.22.02; or (v) Any other provider-owned or controlled residence. (14) “Institution” means an establishment that furnishes, in single or multiple facilities, food, shelter, and some treatment or services to four or more individuals unrelated to the proprietor. (15) “Instrumental activities of daily living” means tasks or activities that include, but are not limited to: (a) Preparing meals; (b) Performing light chores that are incidental to the personal assistance services provided to the participant; (c) Shopping for groceries; (d) Nutritional planning; (e) Traveling as needed; (f) Managing finances and handling money; (g) Using the telephone or other appropriate means of communication; (h) Reading; and (i) Planning and making decisions. (16) “Medicaid” means the Program, administered by the State of Maryland under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for categorically eligible and medically needy participants. (17) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, ameliorative, palliative, or rehabilitative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, the participant’s family, the provider, or the worker. (18) “Nurse” means an individual who is currently licensed to practice nursing in the State under COMAR 10.27.01. (19) “Nurse monitor” means a registered nurse who completes nursing assessments on participants and evaluates the delivery of care. (20) “Nursing facility” means a facility which is participating in the Maryland Medical Assistance Program as a nursing facility pursuant to COMAR 10.09.10. (21) “Participant” means an individual who: (a) Has been determined to meet the qualifications for participation in Community First Choice as specified in Regulation .04 of this chapter; and (b) Is enrolled with the Department to receive Medicaid services. (22) “Personal assistance provider agency” means a public or private agency that: (a) Employs or contracts with personal assistance workers; and (b) Has been enrolled by the Program as a provider of personal assistance services. (23) Personal Assistance Services. (a) “Personal assistance services” means assistance specific to the functional needs of a participant with a chronic illness, medical condition, or disability. (b) “Personal assistance services” includes: (i) Assistance with activities of daily living and instrumental activities of daily living; and (ii) The performance of delegated nursing function. (24) “Plan of service” means the written support plan that: (a) Reflects what is important to the individual and what is important for his or her welfare; and (b) Is developed with support from the supports planner with input from the individual and, when applicable, the individual’s representative. (25) “Preauthorized” means approved by the Department or its designee before services can be rendered. (26) “Program” means the Maryland Medicaid Program. (27) “Provider” has the same meaning as defined in COMAR 10.09.36. (28) “Provider agreement” means a contract between the Department and the provider for rendering the services under this chapter. (29) “Quality plan” means the plan developed by the Department to address quality assurance and oversight. (30) “Recommended plan of care” means the recommended service plan developed by a nurse after a face-to-face evaluation of an applicant or participant. (31) “Representative” means: (a) The person authorized by the individual to serve as a representative in connection with the provision of Community First Choice services and supports; (b) The individual who signs the plan of service on the participant’s behalf; (c) Any individual who makes decisions on behalf of the participant related to the participant’s plan of service; (d) A legal guardian of the individual for the participant; or (e) The parent or foster parent of a dependent minor child. (32) “Supports planner” means an individual who coordinates services, including: (a) Supporting development of a plan of service; (b) Interacting with third parties on behalf of, or in conjunction with, the applicant or participant; and (c) Ensuring an accurate plan of service is provided to the Department. (33) “Telephonic timekeeping system” means a system developed by the Department for workers to time stamp the start and finish of services provided to a participant. (34) “Worker” means an individual who is employed by or contracts with a personal assistance provider agency to provide personal assistance services. #### Regulation .03 Requirements for Provider Licensing or Certification. *COMAR 10.09.84.03* The following health professionals providing services under this chapter shall be licensed to practice in the jurisdiction in which services are rendered: A. Physicians; B. Registered nurses; C. Licensed practical nurses; D. Certified medication technicians; E. Certified nursing assistants; F. Occupational therapists; G. Physical therapists; H. Speech pathologists; I. Nutritionists; and J. Dietitians. #### Regulation .04 Participant Eligibility. *COMAR 10.09.84.04* A. To participate in the Program, a participant shall: (1) Be determined by the Department to need the level of care provided in a hospital, nursing facility, an intermediate care facility for individuals with intellectual disabilities, an institution providing psychiatric services for individuals younger than 21 years old, or an institution for mental diseases for individuals 65 years old or older; (2) Be eligible for Medicaid under an eligibility group defined in COMAR 10.09.24, except for Regulations .03C, .03-1—.03-3, and .05-2; and (3) Reside at home. B. To be eligible for participation, a participant shall have an active plan of service. The plan of service shall: (1) Be based on: (a) The evaluation and recommended plan of care; and (b) Consultation with the applicant or participant; (2) Address the applicant’s or participant’s health and safety needs; (3) Specify the items and services needed to safely support the participant in the community, including: (a) A plan for receiving personal assistance services in case of an emergency; and (b) Specific requests for items or services that substitute for human assistance; (4) Specify the provider agency providing personal assistance services; and (5) Include the signature of the: (a) Participant or, when applicable, the individual’s representative; (b) Supports planner; and (c) Personal assistance provider agency listed within the plan of service. C. A participant’s eligibility for services shall be re-evaluated by the Department every 12 months, or more frequently if needed due to a significant change in the participant’s condition or needs. D. Participant eligibility shall be terminated if the participant: (1) No longer meets the required level of care; (2) No longer resides at home; (3) Is without services for 30 consecutive calendar days; (4) Voluntarily chooses, or the participant’s legal representative chooses on the participant’s behalf, to disenroll from the Program; (5) Moves to another state; (6) Is an inpatient for 30 consecutive days or more in an institutional setting, including but not limited to a chronic hospital or nursing facility; or (7) Dies. #### Regulation .05 Conditions for Provider Participation — General Requirements. *COMAR 10.09.84.05* A. To participate as a provider of a service covered under this chapter, a provider: (1) Shall meet all of the conditions for participation as a Medicaid provider as set forth in COMAR 10.09.36, except as otherwise specified in this chapter; (2) Shall obtain written verification of the qualifications of all individuals who render services on the provider’s behalf and provide a copy of the current license or credentials on request; (3) Shall implement the reporting and follow-up of incidents and complaints in accordance with the Department’s established policy by: (a) Reporting incidents and complaints within 24 hours of knowledge of the event; (b) Submitting a written report within 7 calendar days on a form designated by the Department; and (c) Notifying the local department of social services immediately if the provider has a reason to believe that the participant has been subjected to abuse, neglect, self-neglect, or exploitation, in accordance with COMAR 07.02.16; (4) Shall agree to cooperate with required inspections, reviews, and audits by authorized governmental agents; (5) Shall agree to provide services, and to subsequently bill the Department in accordance with the reimbursement methodology specified in this chapter, for only those services covered under this chapter which have been: (a) Preauthorized in the participant’s plan of service; (b) Provided in a manner consistent with the participant’s plan of service; and (c) Identified in the provider agreement as within the scope of the provider’s Medicaid participation; (6) Shall agree to maintain and have available written documentation of services, including dates and hours of services provided to participants, for a period of 6 years from the date of service, in a manner approved by the Department; (7) Shall agree not to suspend, terminate, increase, or reduce services for an individual without authorization from the Department and only after consultation and input from the participant or, when applicable, the participant’s representative; (8) Shall submit a transition plan to the case manager or supports planner and participant or, when applicable, the participant’s representative when suspending or terminating services; (9) Shall verify Medicaid eligibility at the beginning of each month that services will be rendered; (10) May not be a Medicaid provider or principal of a Medicaid provider that has overpayments that remain due to the Department; and (11) Shall be free from conflicts of interest. B. To participate as a provider of a service covered under this chapter, a provider or its principals may not, within the past 24 months, have: (1) Had a license or certificate suspended or revoked as a health care provider, health care facility, or direct care services worker; (2) Been suspended or removed from participating as a Medicaid provider under COMAR 10.09.20; (3) Undergone the imposition of sanctions under COMAR 10.09.36.08; (4) Been subject to disciplinary action, including actions by the licensing board or any provider or principal of any provider agency; (5) Been cited by a State agency for deficiencies which affect participants’ health and safety; or (6) Experienced a termination of a Medicaid provider agreement or been barred from work or participation by a public or private agency due to: (a) Failure to meet contractual obligations; or (b) Fraudulent billing practices. C. A provider who renders health-related services to participants shall agree to: (1) Periodically provide information about a participant in accordance with the procedures and forms designated by the Department; and (2) Share and discuss the documented information at the request of the participant. #### Regulation .06 Specific Conditions for Provider Participation — Personal Assistance. *COMAR 10.09.84.06* A. Personal assistance service providers shall: (1) Be licensed as a Residential Service Agency under COMAR 10.07.05 to provide Level Two or Level Three home care services; (2) Employ a registered nurse who shall: (a) Assess each new participant who requires personal assistance services; (b) Participate in developing the worker instructions and in assigning appropriate personnel; (c) Delegate nursing tasks, as appropriate, to a CNA or a CMT in accordance with COMAR 10.27.11; and (d) Participate in instructing the workers who will provide the assistance, when indicated; (3) Employ workers who will accept instruction on the personal assistance services required in the participant’s plan of service from the following: (a) The participant or, when applicable, the participant’s representative; (b) The nurse monitor; (c) A treating physician or nurse practitioner; or (d) An individual from the Department; (4) Allow participants to have a significant role in the delivery of their specific care including: (a) Directing the services and supports identified in their plan of service; and (b) Exercising as much control as desired to select, train, schedule, determine duties, and dismiss the personal assistance worker in their home; (5) Notify the Department in writing at least 45 days in advance of any: (a) Voluntary closure; (b) Change of ownership; (c) Change of location; (d) Sale of the business; (e) Change in the name under which the provider is doing business; or (f) Change in provider tax identification number; (6) Include in the notice to the Department the method for informing participants and representatives of its intent to close, change ownership, change location, or sell its business; (7) Include in the notice to the Department, and inform participants and representatives, of the transition plan developed by the agency to ensure continuity of services to participants; (8) If applicable, apply for a new license whenever ownership is to be transferred from the person or organization named on the license to another person or organization in time to assure continuity of services; (9) Submit a Medicaid provider application to the Department if the new owner chooses to participate in the Program; (10) At least monthly, collect and maintain the participant’s signature, or that of the participant’s representative when applicable, verifying services rendered; and (11) Conduct a criminal history records check on all direct service workers including nurses, in accordance with the procedure for a State criminal history records check established under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland. B. A worker who performs delegated nursing services in accordance with COMAR 10.27.11 shall: (1) If required to administer medications in accordance with the plan of service, be a certified medications technician; and (2) If performing other delegated nursing functions, also be a certified nursing assistant. C. A personal assistance provider agency may not assign the participant’s representative to provide services to that participant. #### Regulation .07 Specific Conditions for Provider Participation — Supports Planning. *COMAR 10.09.84.07* To participate in the Program as a supports planning provider under Regulation .15 of this chapter, a provider shall: A. Agree to be monitored by the Department; and B. Be: (1) Identified by the Department through a solicitation process; or (2) The area agency on aging that is enrolled to provide case management services under COMAR 10.09.54. #### Regulation .08 Specific Conditions for Provider Participation — Consumer Training. *COMAR 10.09.84.08* To participate in the Program as a provider of consumer training under Regulation .16 of this chapter, a provider shall: A. Be a self-employed trainer or an agency that employs qualified trainers in accordance with §B of this regulation; B. Have demonstrated experience with the skill being taught; and C. Be willing to meet at the participant’s home to provide services. #### Regulation .09 Specific Conditions for Provider Participation — Personal Emergency Response Systems. *COMAR 10.09.84.09* To participate in the Program as a provider of personal emergency response systems under Regulation .17 of this chapter, a provider shall: A. Be the store, vendor, organization, or company which sells, rents, installs, services, or operates the device or service; B. Provide or arrange for any installation, maintenance, training, or monitoring required for the device or system; C. Ensure that any response center is: (1) Responsible for monitoring and responding to a notification of an emergency by the system; and (2) Adequately staffed 24 hours a day, 7 days a week by properly trained staff; and D. Submit reports to the Department regarding activation and participant use no less than monthly or at a greater frequency as requested by the Department. #### Regulation .10 Specific Conditions for Provider Participation — Items or Services that Substitute for Human Assistance. *COMAR 10.09.84.10* A. To participate in the program as a provider of items or services that substitute for human assistance, the provider shall: (1) Be approved and monitored by the Department; (2) Provide or arrange for any installation, maintenance, training, or monitoring required for the proper operation of the device or system, if applicable; and (3) Receive a referral from the participant, participant’s case manager, or supports planner, based on services preauthorized in the plan of service. B. To participate in the Program as a provider of home-delivered meals, the provider shall: (1) Use a cooking facility or food preparation site that has a food service license issued by the local health department, in accordance with COMAR 10.15.03, or an appropriate license from the state in which the site is located; and (2) Be approved for each licensing renewal based on inspections performed by State sanitarians in accordance with COMAR 10.15.03, or by the licensing authority in the state in which the site is located. C. To participate in the Program as a provider of assistive devices, equipment, or technology services, the provider shall be one of the following entities: (1) A Program provider of disposable medical supplies and durable medical equipment under COMAR 10.09.12; or (2) The store, vendor, organization, or company which sells or rents the equipment or system, subject to Department approval. D. To participate as a provider of accessibility adaptations a provider shall: (1) Have a current license with the Maryland Home Improvement Commission; and (2) Be approved by the Department. #### Regulation .11 Specific Conditions for Provider Participation — Environmental Assessments. *COMAR 10.09.84.11* To participate in the Program as a provider of environmental assessments under Regulation .19 of this chapter, the provider shall: A. Be a licensed occupational therapist, or an agency or professional group employing a licensed occupational therapist; B. Receive a referral from the participant’s supports planner, based on services preauthorized in the plan of service; and C. Document the provider’s findings and recommendations on a form approved by the Program. #### Regulation .12 Specific Conditions for Provider Participation — Nurse Monitoring. *COMAR 10.09.84.12* To participate in the Program as a nurse monitoring provider under Regulation .20 of this chapter, a provider shall: A. Be designated by the Department through a process approved by the Centers for Medicare and Medicaid Services in accordance with §1915(b)(4) of the Social Security Act; B. Employ or contract with registered nurses who hold a current professional license to practice in Maryland; C. Agree to accept all referrals from the Department; and D. Agree to be monitored by the Department. #### Regulation .13 Covered Services — General. *COMAR 10.09.84.13* The Program shall reimburse for the services specified in Regulations .14—.21 of this chapter, when, pursuant to the requirements of this chapter, these services have been preauthorized by the Department in the participant’s plan of service, billed in accordance with the payment procedures in Regulation .24 of this chapter, and documented as necessary to prevent institutionalization. #### Regulation .14 Covered Services — Personal Assistance. *COMAR 10.09.84.14* A. The Program covers personal assistance services that are approved in the plan of service and rendered to a participant by a qualified provider in the participant’s home or a community setting. B. The Program covers the following services when provided by a personal assistance provider: (1) Assistance with activities of daily living; (2) Delegated nursing functions if this assistance is: (a) Specified in the participant’s plan of service; and (b) Rendered in accordance with the Maryland Nurse Practice Act, COMAR 10.27.11, and other requirements of the Maryland Board of Nursing; (3) Assistance with tasks requiring judgment to protect a participant from harm or neglect; (4) Assistance with or completion of instrumental activities of daily living, provided in conjunction with the services covered under §B(1)—(3) of this regulation; and (5) Assistance with the participant’s self-administration of medications, or administration of medications or other remedies, when ordered by a physician. C. Personal assistance services may not include: (1) Services rendered to anyone other than the participant or primarily for the benefit of anyone other than the participant; (2) The cost of food or meals prepared in or delivered to the home or otherwise received in the community; or (3) Housekeeping services, other than those incidental to services covered under §B of this regulation. #### Regulation .15 Covered Services — Supports Planning. *COMAR 10.09.84.15* A. Supports planning services shall: (1) Address the individualized needs of the participant; (2) Be sensitive to the educational background, culture, and general environment of the participant; (3) Support the participant to self-direct services and exercise as much control as desired to select, train, supervise, schedule, determine duties, and dismiss the personal assistance worker; and (4) Ensure freedom of choice among any willing provider for all services. B. Supports planning services include the following activities: (1) Assisting the participant in developing a plan of service in consultation with the applicant or participant and any individual requested by the participant; (2) Assisting the participant with referral, access, and coordination of services, both Medicaid and non-Medicaid, to address the participant’s needs including, but not limited to: (a) Behavioral health; (b) Educational services; (c) Disposable medical supplies and durable medical equipment; (d) Housing; (e) Medical services; and (f) Social services; (3) Monitoring the provision of services to determine if services are received in accordance with the plan of service; (4) Using information technology systems developed by the Department; (5) Coordinating with the fiscal intermediary to assist in managing budgeted resources; (6) Providing guidance and support to help individuals self-direct their services; and (7) Administering funds for transition services. #### Regulation .16 Covered Services — Consumer Training. *COMAR 10.09.84.16* A. Consumer training includes instruction and skill building in such areas including, but not limited to, acquisition, maintenance, and enhancement of skills necessary for the participant to accomplish ADLs and IADLs. B. The topics covered by consumer training shall be: (1) Targeted to the individualized needs of the participant receiving the training; and (2) Sensitive of the educational background, culture, and general environment of the participant receiving the training. C. Consumer training does not include time spent by the provider: (1) Planning, preparing, or setting up the training; or (2) Following up after the training. #### Regulation .17 Covered Services — Personal Emergency Response Systems. *COMAR 10.09.84.17* A. The Program covers the following related to a device, system, or piece of equipment described under §B of this regulation: (1) Purchase and installation; (2) Monthly cost of a covered system or rented device or equipment, including monitoring, maintenance, and repair. B. A personal emergency response system is an electronic device or system which enables a participant to secure help in an emergency and may include but is not limited to: (1) A device connected to the participant’s telephone or other device and programmed to signal, upon activation of a help button, a response center with properly trained staff on duty 24 hours a day, 7 days a week; (2) A portable help button to allow for the participant’s mobility; and (3) A motion detector when necessary for the participant’s safety. #### Regulation .18 Covered Services — Items or Services that Substitute for Human Assistance. *COMAR 10.09.84.18* A. The program covers items or services that increase a participant’s independence or substitute for human assistance, to the extent that expenditures would otherwise be made for the human assistance. B. Each item or service shall: (1) Be preauthorized in the participant’s plan of service as necessary to: (a) Prevent the participant’s institutionalization; and (b) Ensure the participant’s health, safety, and independence; (2) Specifically relate to ADLs or IADLs within the approved plan of service; (3) Comply with policies and procedure guidance defined by the Department; (4) Meet necessary standards of manufacture, design, usage, and installation, if applicable; (5) Be provided in accordance with applicable State and local building codes and pass required inspections, if applicable; and (6) Not be prescribed primarily to provide comfort or convenience. C. Each item or service shall be confirmed by the Program as not covered for the participant by: (1) Medicaid under the State Plan as durable medical equipment or pharmacy services under COMAR 10.09.03, 10.09.12, or 10.09.67; (2) Medicare; or (3) Any other third-party payer. D. The Program covers home-delivered meals provided during meal periods that personal assistance services are not provided. Home-delivered meals shall be: (1) Delivered to the participant’s home; (2) Intended for consumption at home; (3) Nutritionally adequate for the participant’s age based on the Recommended Dietary Allowance (RDA) or Dietary Reference Intake (DRI), as established by the Food and Nutrition Board of the National Research Council and demonstrated by having the menus certified in writing by a physician, dietitian, or nutritionist; and (4) At least one-third of the RDA, DRI, or therapeutic diet requirements ordered by the participant’s physician, dietitian, or nutritionist, including any ordered nutritional supplements. E. Technology that substitutes for human assistance includes: (1) Environmental controls for the home or automobile; (2) Personal computers, software, or accessories; (3) Augmentative communication devices; (4) Maintenance or repair of technology devices; (5) Self-help aids that assist with activities of daily living or instrumental activities of daily living; and (6) Assessments and training in the use of assistive technology. #### Regulation .19 Covered Services — Environmental Assessments and Adaptations. *COMAR 10.09.84.19* A. The Program covers an on-site environmental assessment and adaptations of a home or residence where the participant lives or will live as a participant. B. An environmental assessment or adaptation may not be provided before the effective date of the participant’s enrollment in services. C. The environmental assessment may be recommended by a multidisciplinary team in the plan of service for a participant when an environmental assessment is considered necessary to: (1) Ensure the health and safety of a participant with special environmental needs; and (2) Obtain additional professional advice from an occupational therapist about the: (a) Physical structure of a participant’s home or residence; and (b) Functional or mental limitations or disabilities of a participant as they relate to the environment. D. Included in the environmental assessment, as necessary, may be: (1) An evaluation of the presence and likely progression of a disability or a chronic illness or condition in a participant; (2) Environmental factors in the facility or home; (3) The participant’s ability to perform activities of daily living; (4) The participant’s strength, range of motion, and endurance; and (5) The participant’s need for assistive devices and equipment. E. Based on an inspection of the home and interviews with the participant and any individual requested by the participant, the provider shall complete a form, to be reviewed by the supports planner, which details the provider’s findings and recommendations, especially relating to a participant’s need for services. #### Regulation .20 Covered Services — Nurse Monitoring. *COMAR 10.09.84.20* A. The program covers the following services when provided by a nurse monitor: (1) Being available to give instruction and to answer questions; (2) Complying with the Department’s reportable events policy; and (3) Maintaining an up-to-date client profile in an electronic database designated by the Department. B. The Program covers nurse monitoring services according to the following schedule: (1) Contact with the participant for the purpose of reviewing participant status at a minimum of every 6 months with at least one in-person home or workplace visit every 12 months; and (2) Additional nurse monitoring services at a frequency established in conjunction with the participant or, when applicable, the participant’s representative, based on the participant’s medical condition or clinical status. C. Home and Workplace Visits. (1) The nurse monitoring provider shall use the home or workplace visit for the following purposes: (a) To assess the participant’s condition; (b) To assess the quality of personal assistance services; and (c) To determine the need for discharge from personal assistance services or referral to other services. (2) The nurse monitor shall assess the quality of personal assistance services by: (a) Reviewing documentation related to the provision of personal assistance services; and (b) Observing the performance of the worker, as appropriate. #### Regulation .21 Covered Services § Transition Services. *COMAR 10.09.84.21* A. Definition. “Transition service” means a service that is: (1) Not otherwise available under the Program; (2) Approved in the plan of service; and (3) Rendered to assist the participant in transitioning from an institution or a provider-owned residence to a home or community-based residence. B. Transition services may include all or some of the following: (1) Security deposits; (2) Essential furnishings and moving expenses; (3) Set-up fees or deposits for utility services; and (4) Other health and safety assurances. C. Transition services may not include recreational items including, but not limited to: (1) Televisions; (2) Cable television access; or (3) Gaming systems. #### Regulation .22 Conditions for Reimbursement. *COMAR 10.09.84.22* The Program shall reimburse for the services specified in Regulations .14—.21 of this chapter, if provided in accordance with the requirements of this chapter and if the service: A. Is recommended on the participant’s plan of service as necessary in order to: (1) Prevent the applicant’s or participant’s admission to an institution; (2) Safely transition the applicant or participant from an institution, such as a nursing facility, into the community; or (3) Assure the health and safety of an applicant or participant in the community; B. Has been preauthorized by the Department in the participant’s plan of service; C. Is provided to an enrolled participant; D. Is medically necessary; and E. Is provided by a Medicaid provider who meets the conditions for participation under this chapter. #### Regulation .23 Limitations. *COMAR 10.09.84.23* A. Reimbursement for Personal Emergency Response System is limited to participants who: (1) Live alone; or (2) Have no regular caregiver for extended parts of the day and would otherwise require extensive routine supervision to ensure the participant’s health and safety. B. The Department shall establish a budget for personal assistance services and home-delivered meals that may be included in the participant’s plan of service, based on each participant’s assessed need. C. The Program does not cover the following services: (1) Service primarily for the purpose of housekeeping unrelated to the participant’s activities of daily living, such as: (a) Cleaning of the floor and furniture in areas not occupied by the participant; (b) Laundry other than that incidental to services for the participant; and (c) Shopping for groceries or household items unless in the company of the participant; (2) Services provided by providers not approved for participation by the Department; (3) Expenses incurred while escorting participants: (a) To obtain medical diagnosis or treatment; (b) To or from the participant’s workplace; or (c) For participation in social or community activities; (4) Expenses related to room and board for either the participant or the worker; (5) Transition services more than 60 days post transition; (6) Personal assistance services provided outside the State for more than 30 days per calendar year; (7) Environmental adaptations to the home which: (a) Are of general maintenance, such as carpeting, roof repair, and central air conditioning; (b) Are not of direct medical or remedial benefit to the participant; (c) Add to the home’s total square footage; or (d) Modify the exterior of the home, other than the provision of ramps, lifts, sidewalks necessary to utilize a ramp or lift, and railings; or (8) Experimental technology or equipment. D. Payment for supports planning and nurse monitoring services shall be limited to direct services to the participant and may not be made for: (1) Administrative overhead; (2) Travel; (3) Internal quality monitoring activities; (4) Staff supervision, training, or consultation; or (5) Services rendered by an individual supports planner or nurse monitor in excess of 7 hours per day unless preauthorized by the Department in writing. E. Payment for environmental adaptations and technology that substitutes for human assistance is limited to a combined reimbursement of up to $15,000 over a 3-year period per participant. F. For technology items or services above $1,000, multiple quotes from providers are required. #### Regulation .24 Payment Procedures. *COMAR 10.09.84.24* A. Request for Payment — Personal Assistance. To receive payment as a personal assistance provider agency under Regulation .14 of this chapter, a provider and its workers shall use the telephonic timekeeping system approved by the Department to: (1) Document time; and (2) Submit claims. B. Request for Payment — All Other Covered Services. To receive payment as a provider of services covered under Regulations .15—.21 of this chapter, a provider shall submit claims in accordance with procedures outlined in the Department’s billing manual. C. Billing time limitations are set forth in COMAR 10.09.36.06. D. Payments. (1) Payments for services rendered to a participant shall be made directly to a qualified provider. (2) A provider shall be paid the lesser of: (a) The provider’s usual and customary charge to the general public unless the service is free to individuals not covered by Medicaid; or (b) The rate established according to the fee schedule published by the Department. E. Effective May 1, 2017, for personal assistance services up to 12 hours per day, payment will be made in 15-minute units of service. For individuals who are determined to need more than 12 hours of personal assistance per day, a daily rate for the service will be paid. F. Rates. (1) The Department shall publish a fee schedule for services covered under this chapter which shall be publicly available and updated at least annually or upon any changes made by the Department. (2) Effective July 1, 2018, the Program’s rates for covered services under Regulations .14—.16, .18D, .19, and .20 of this chapter shall increase on July 1 of each year by 3 percent, subject to the limitations of the State budget. #### Regulation .25 Recovery and Reimbursement. *COMAR 10.09.84.25* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .26 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.84.26* Cause for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .27 Appeal Procedures — Providers. *COMAR 10.09.84.27* Appeal procedures shall be as set forth in: A. COMAR 10.09.36.09; and B. COMAR 10.01.03. #### Regulation .28 Appeal Procedures — Applicants and Participants. *COMAR 10.09.84.28* Appeal procedures for applicants and participants are those set forth in: A. COMAR 10.09.24.13; and B. COMAR 10.01.04. #### Regulation .29 Interpretive Regulation. *COMAR 10.09.84.29* Interpretive regulatory requirements shall be as set forth in COMAR 10.09.36.10. ### Chapter 85 — Free-Standing Birth Centers **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: May 1, 2014 (41:8 Md. R. 471) #### Regulation .01 Definitions. *COMAR 10.09.85.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Certified nurse midwife (CNM)” means a registered nurse who is certified by the American College of Nurse-Midwives, and is licensed in the state in which the service is provided. (2) “Commission for the Accreditation of Birth Centers (CABC)” means the independent authority that accredits developing and existing birth centers in the United States of America, according to established national standards. (3) “Department” means the Maryland Department of Health. (4) “Free-standing Birth Center” means a free-standing facility not associated with a hospital that provides physician or certified nurse midwifery services. (5) "Medical Assistance Program” means the program, financed by federal, state, and local funds, for the comprehensive medical care for persons of all ages within certain income limits. (6) “Medically necessary” means the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with current accepted standards of good medical practice; (c) The most cost efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (7) “Newborn” means an infant who is not more than 48 hours old. (8) “Participant” means an individual who is eligible for Program benefits. (9) “Physician” means an individual legally licensed to practice medicine by the Board or in the state in which the physician's practice is located. (10) “Program” means the Maryland Medical Assistance Program. (11) “Provider” means a free-standing birth center. #### Regulation .02 License Requirements. *COMAR 10.09.85.02* A. A free-standing birth center shall be certified by the Commission for the Accreditation of Birth Centers, and: (1) Be licensed to operate in Maryland pursuant to Health General Article 19, Subtitle 3b, Annotated Code of Maryland and in accordance with the requirements as set forth in COMAR 10.05.02; or (2) If located out-of-State, comply with the regulations of the jurisdiction in which the free-standing birth center is located. B. The free-standing birth center shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided. C. A CNM providing services in a free-standing birth center shall meet the license requirements in accordance with COMAR 10.09.21.02B. D. A physician providing services in a free-standing birth center shall meet the requirements in accordance with COMAR 10.09.02.02B. #### Regulation .03 Conditions for Participation. *COMAR 10.09.85.03* A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. Specific requirements for participation in the Program as a free-standing birth center require that the provider: (1) Verify the licenses and credentials of all clinical professionals employed by or under contract with the free-standing birth center as set forth in COMAR 10.05.02.04. (2) Maintain adequate documentation of each participant’s delivery service and newborn care as set forth in COMAR 10.05.02.11. (3) Comply with safety requirements as set forth in COMAR 10.05.02.09 and COMAR 10.05.02.10. #### Regulation .04 Covered Services. *COMAR 10.09.85.04* The Program covers the facility-related services provided by the free-standing birth center for the care of the delivering mother and newborn, and covers the cost of; A. Support staff; B. The use of the free-standing birth center; and C. Supplies, linens, and equipment. #### Regulation .05 Limitations. *COMAR 10.09.85.05* A. The Program does not cover laboratory or x-ray services performed by another facility. The facility performing these services shall bill the Program directly. B. Professional services are to be billed separately from the free-standing birth center facility fee. #### Regulation .06 Payment Procedures. *COMAR 10.09.85.06* A. The Program will reimburse free-standing birth centers for: (1) A facility fee of $2,000 for the care of the delivering mother and delivery of the newborn, if the delivery takes place at the facility; and (2) A facility fee of $500 for the care of the newborn. B. If the mother is transferred to a hospital prior to delivering the newborn, the Department will reimburse as follows: (1) If the mother was at the birth center for less than 2 hours, before the delivery of the newborn, the reimbursement will be at 25 percent of the Medicaid rate; (2) If the mother was at the birth center for 2 to 5 hours, before the delivery of the newborn, the reimbursement will be at 50 percent of the Medicaid rate; (3) If the mother was at the birth center for 5 to 8 hours, before to the delivery of the newborn, the reimbursement will be at 70 percent of the Medicaid rate; and (4) If the mother was at the birth center for more than 8 hours, before the delivery of the newborn, the reimbursement will be at the full Medicaid rate. C. The Program shall pay for covered services at the lower of the: (1) Provider's customary charge to the general public; or (2) The Program’s fee. D. The provider shall submit a request for payment as set forth in COMAR 10.09.36.04A. E. The Program reserves the right to return to the provider, before payment, all invoices that are not properly completed. F. The Program may not make a direct payment to a recipient. G. Billing time limitations for claims submitted under this chapter are set forth in COMAR 10.09.36.06. #### Regulation .07 Recovery and Reimbursement. *COMAR 10.09.85.07* A. If the recipient has insurance or if any other person is obligated either legally or contractually to pay for or to reimburse for any service covered by this chapter, the provider shall seek payment from that source first. If an insurance carrier rejects the claim or pays less than the amount allowed by the Medical Assistance Program, the provider may submit a claim to the Department. The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the claim. If payment is made by both the Program and by the insurance or other source for the same service, the provider shall refund to the Department, within 60 days of receipt, the amount paid by the Program, or by the insurance or other source, whichever is less. B. The provider shall reimburse the Department for any overpayment. #### Regulation .08 Cause for Suspension or Removal and Imposition of Sanctions *COMAR 10.09.85.08* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08 #### Regulation .09 Appeals Procedures. *COMAR 10.09.85.09* Appeal procedures are as set forth in COMAR 10.09.36.09. #### Regulation .10 Interpretive Regulation. *COMAR 10.09.85.10* General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10. ### Chapter 86 — Maryland Medicaid Managed Care Program: Independent Review Organization (IRO) *Transferred to COMAR 10.67.13* **Administrative History:** Effective date: April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .08B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred to COMAR 10.67.13 effective November 1, 2019 (46:22 Md. R. 977) ### Chapter 87 — Free-Standing Independent Diagnostic Testing Facilities **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 28, 2014 (41:8 Md. R. 472) **Administrative History:** Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .07B amended effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .07C, I amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07D amended effective February 27, 2017 (44:4 Md. R. 252) #### Regulation .01 Definitions. *COMAR 10.09.87.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “CMS” means Centers for Medicare and Medicaid Services. (2) “Department” means Maryland Department of Health. (3) "Independent Diagnostic Testing Facility (IDTF)” means a fixed location or mobile entity independent of a hospital or physician’s office where diagnostic services are performed by licensed certified non-physician personnel under appropriate physician supervision. (4) “Major medical equipment” means: (a) All cardiac catheterization equipment necessary to perform heart catheterization; (b) A computerized tomography (CT) scanner; (c) A lithotriptor; (d) Radiation therapy equipment, including a linear accelerator; and (e) A Magnetic Resonance Imager (MRI). (5) “Mammography” means the radiographic examination of the soft tissues of the breast. (6) “Medically necessary” means medically necessary as defined in COMAR 10.09.36.01. (7) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (8) “NPI” means National Provider Identifier. (9) “Program" means the Maryland Medical Assistance Program. #### Regulation .02 License Requirements. *COMAR 10.09.87.02* A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02. B. A facility or mobile unit that is operating radiological equipment shall be licensed or certified and registered by the Department of the Environment in accordance with COMAR 26.12.01 through COMAR 26.12.03. C. A facility that performs mammography services shall be certified by the Food and Drug Administration (FDA). D. A facility operating major medical equipment shall meet all the general licensing requirements for a facility as provided in COMAR 10.05.03.02. E. The driver of the Mobile IDTF unit: (1) Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; and (2) May not have: (a) Violations related to the operation of a motor vehicle in the last 3 years; and (b) Any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years. #### Regulation .03 Conditions for Participation. *COMAR 10.09.87.03* A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. Requirements for participation in the Program as an IDTF provider/mobile IDTF provider require that the provider: (1) Be approved by Medicare to furnish diagnostic services in an IDTF; (2) Meets the licensure requirements in accordance with Regulation .02 of this chapter; and (3) Meets performance standards in accordance with 42 CFR §410.33(g). C. Specific Requirements for Participation in the Program as a Mobile IDTF Provider. (1) The mobile IDTF shall have electronic technology that enables the same day exchange of patient records with the treating physician’s office. (2) An IDTF mobile unit shall: (a) Maintain physician’s order & diagnostic test records for each patient; (b) Observe all patient rights; (c) Obtain written, informed consent from a parent or legal guardian before providing services to a minor; (d) Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating: (i) Equipment; (ii) Flammability; (iii) Construction; (iv) Infection control; (v) Sanitation procedures; and (vi) Zoning; (e) Comply with the statutes and regulations of the Maryland Department of the Environment for all radiographic and imaging equipment; (f) Obtain all applicable county and city licenses or permits necessary to operate the mobile IDTF; (g) Provide access to a ramp or a lift if services are provided to disabled individuals; (h) Have ready access to an adequate supply of potable water, including hot water; (i) Have immediate access to toilet facilities; (j) Have an appropriately covered noncorrosive metal container for refuse and waste materials; (k) Have a carbon monoxide detection device or system installed and in proper working condition; (l) Have written procedures for medical emergencies; and (m) Have appropriate equipment to treat medical emergencies. (3) The owner or owners of a mobile unit shall submit a business plan to the Department for the mobile unit that includes: (a) The mission of the mobile unit; (b) Verification of ownership of the mobile unit; (c) A list of the technical staff that will render services in the mobile unit; and (d) The targeted population. #### Regulation .04 Covered Services. *COMAR 10.09.87.04* A. The Program covers medically necessary radiology services rendered to a recipient in an IDTF when the services are: (1) Rendered in a CMS certified IDTF or an IDTF Mobile Unit; (2) Provided according to the laws and regulations of the state and locality in which they are rendered; (3) Rendered by a physician or supervised technician; (4) Ordered in writing by the treating physician or non-physician practitioner, in accordance with State law, who is enrolled as a provider in the Program with an active status on the date of service; and (5) Adequately documented in the recipient’s medical record. B. Radiology services include the following: (1) Diagnostic X-rays; (2) Computerized Tomography (CT) procedures; (3) Magnetic Resonance Imaging (MRI); (4) Magnetic Resonance Angiography (MRA); (5) Nuclear medicine imaging and radionuclide used in the procedures; (6) Diagnostic mammography and certain mammography screening; (7) Ultrasound (US procedures); (8) Position Emission Tomography (PET); (9) Radiation oncology; and (10) Bone mass measurements. C. Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Nuclear Medicine Imaging to include Position Emission Tomography (PET) are covered only when billed by providers who are accredited by one of the following: (1) The American College of Radiology; (2) The Intersocietal Accreditation Commission; or (3) The Joint Commission on Accreditation of Health Organizations (JCAHO). #### Regulation .05 Limitations. *COMAR 10.09.87.05* The Program does not cover the following: A. Services for which the IDTF provider cannot supply a properly completed order identifying the authorized ordering practitioner by National Provider Identifier (NPI); B. IDTF services ordered by an: (1) Individual who is not enrolled as a provider in the Program with an active status on the date of service; and (2) Entity, facility, or another provider that is not an individual. C. Services not adequately documented in the recipient’s medical record; D. Services not medically necessary; E. Procedures that are the provider as investigational or experimental in nature; F. Services which are specifically included as an integral part of another service; G. Consultations; H. Office Visits; I. Injections; J. Surgeries; and K. Therapeutic services. #### Regulation .06 Preauthorization Requirements. Reserved. *COMAR 10.09.87.06* #### Regulation .07 Payment Procedures. *COMAR 10.09.87.07* A. General policies for payment that are applicable to all providers are set forth in COMAR 10.09.36.04. B. IDTF providers shall identify the individual who ordered the diagnostic services by either: (1) Recording the National Provider Identifier (NPI) number for the individual provider on the claim; or (2) Recording the name and NPI of the authorized ordering provider on the invoice and attaching to the invoice a copy of the properly completed order that identifies the authorized ordering provider. C. The Department shall reimburse the IDTF providers for covered services at the lesser of: (1) The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or (2) The Department’s fee schedule. D. The Department’s fee-schedule is contained in COMAR 10.09.02.07D. E. Payments on Medicare cross-over claims are authorized if: (1) The provider accepts Medicare assignment; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that the services are medically necessary; (4) Initial billing is made directly to Medicare according to Medicare guidelines. F. The Department shall make supplemental payment on Medicare cross-over claims subject to the following provisions: (1) Coinsurance shall be paid at the lesser of: (a) 100 percent of the coinsurance amount; or (b) The balance remaining after the Medicare payment is subtracted from the Medicaid rate. G. The Program may not make a direct payment to a recipient. H. Billing time limitations are those set forth in COMAR 10.09.36.06. I. The provider may not bill the Program or recipient for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Services rendered by mail or telephone; and (4) Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.87.08* General policies governing recovery and reimbursement procedures that are applicable to all providers are set forth in COMAR 10.09.36.07. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.87.09* General policies governing the cause for suspension and removal and imposition of sanctions procedures that are applicable to all providers are set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.87.10* General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. ### Chapter 88 — Portable X-ray Providers **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 28, 2014 (41:8 Md. R. 472) **Administrative History:** Regulation .04A amended effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .05K adopted effective January 1, 2018 (44:26 Md. R. 1214) **Administrative History:** Regulation .07C, I amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .07D amended effective February 27, 2017 (44:4 Md. R. 252) **Administrative History:** Regulation .07J adopted effective January 1, 2018 (44:26 Md. R. 1214) #### Regulation .01 Definitions. *COMAR 10.09.88.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “CMS” means Centers for Medicare and Medicaid Services. (2) “Department” means the Maryland Department of Health. (3) “Mammography” means the radiographic examination of the soft tissues of the breast. (4) “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (5) “Medically necessary” means medically necessary as defined in COMAR 10.09.36.01. (6) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (7) “NPI” means National Provider Identifier. (8) “Program” means the Medical Assistance Program. (9) “Portable X-ray provider” means an entity that moves its portable X-ray equipment that is separate from and unattached to the vehicle to a fixed location (e.g. a physician’s office or nursing home). (10) “Provider” means: (a) An individual, association, partnership, corporation, unincorporated group, or any other person authorized, licensed, or certified to provide services for Program recipients and who, through appropriate agreement with the Department, has been identified as a Program provider by the issuance of an individual account number; (b) An agent, employee, or related party of a person identified in §B(10)(a) of this regulation; or (c) An individual or any other person with an ownership interest in a person identified in §B(10)(a) of this regulation. (11) “Recipient” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. #### Regulation .02 License Requirements. *COMAR 10.09.88.02* A. Providers of Medical Assistance Program services shall, to the extent required by law, be licensed and legally authorized to practice or deliver services in the state in which the service is provided. B. The provider and the equipment personnel shall be licensed or registered in accordance with applicable federal, State and local laws in accordance with 42 CFR §486.100. C. The portable X-ray provider shall be certified and registered by the Department of Environment in accordance with COMAR 26.12.01—.03 D. A portable X-ray provider that performs mammography services shall be certified by the Food and Drug Administration (FDA). E. The driver that transports portable X-ray equipment: (1) Shall possess a valid operator’s license appropriate for the type of vehicle that is driven; (2) May not have violations related to the operation of a motor vehicle in the last 3 years; and (3) May not have any violations involving alcohol or other illegal substances related to the operation of a motor vehicle in the last 10 years. #### Regulation .03 Conditions for Participation. *COMAR 10.09.88.03* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. The provider shall also: (1) Be certified by CMS to furnish portable X-ray services; (2) Meet the licensure requirements as provided in Regulation .02 of this chapter; (3) Meet performance standards in accordance with 42 CFR §410.33(g); (4) Ensure that portable X-ray services are rendered under the supervision of a qualified physician in accordance with 42 CFR §486.102; (5) Ensure that portable X-ray services are rendered by a qualified technician in accordance with 42 CFR §486.104; (6) Ensure that portable X-ray services performed for Medical Assistance recipients are ordered by a doctor of medicine or a doctor of osteopathy and records are properly preserved in accordance with 42 CFR §486.106; (7) Ensure that inspections of all X-ray equipment and shielding are made by qualified individuals at intervals not greater than 24 months in accordance with 42 CFR §486.110; and (8) Identify the ordering practitioner who authorized the diagnostic services by either: (a) Recording the National Provider Identifier (NPI) number for the individual practitioner on the claim; or (b) Recording the name and NPI of the authorized ordering practitioner on the invoice and attaching to the invoice a copy of the properly completed order that identifies the authorized ordering practitioner. #### Regulation .04 Covered Services. *COMAR 10.09.88.04* A. The Program covers medically necessary services rendered to recipients, when the services are: (1) Provided according to the laws and regulations of the State and locality in which they are rendered in accordance with 42 CFR §486.100; (2) Rendered by a physician who meets the qualification standards in accordance with 42 CFR §486.102 or qualified non-physician (technician) who meets the qualification standards in accordance to 42 CFR §486.104; and (3) Ordered in writing by the treating physician or nurse practitioner who is enrolled as a provider in the Program with an active status on the date of service in accordance with State law. B. Portable X-ray services include the following: (1) Skeletal films involving extremities, pelvis, vertebral column, and skull; (2) Chest films which do not involve the use of contrast media; (3) Abdominal films which do not involve the use of contrast media; (4) Diagnostic mammograms, if approved by the FDA; (5) Transportation of portable X-ray equipment to a patient’s home or a long term care facility (LTCF); and (6) Electrocardiograms (EKGs/ECGs). #### Regulation .05 Limitations. *COMAR 10.09.88.05* The Program does not cover the following: A. Services for which the portable X-ray provider cannot provide a properly completed order identifying the authorized ordering physician or practitioner by National Provider Identifier (NPI); B. Services not adequately documented in the recipient’s medical record; C. Services not medically necessary; D. Procedures that are known by the provider as investigational or experimental in nature; E. Services which are specifically included as an integral part of another service; F. Consultations; G. Office visits; H. Injections; I. Surgeries; and J. Therapeutic services. K. X-ray services ordered by an: (1) Individual who is not enrolled as a provider in the Program with an active status on the date of service; and (2) Entity, facility, or another provider that is not an individual. #### Regulation .06 Preauthorization Requirements. Reserved. *COMAR 10.09.88.06* #### Regulation .07 Payment Procedures. *COMAR 10.09.88.07* A. General policies for payment that are applicable to all providers are set forth in COMAR 10.09.36.04. B. The Department shall allow a single transportation payment for each trip the portable X-ray provider makes to a particular location. C. The Department shall reimburse for covered services at the lesser of: (1) The provider’s customary charge unless the service is free to individuals not covered by Medicaid; or (2) The Department’s fee schedule. D. The Department’s fee-schedule is contained in COMAR 10.09.02.07D. E. Payments on Medicare cross-over claims are authorized if : (1) The provider accepts Medicare assignment; (2) Medicare makes direct payment to the provider; (3) Medicare has determined that the services are medically necessary; (4) The services are covered by the program; and (5) The initial billing is made directly to Medicare according to Medicare guidelines. F. The Department shall make supplemental payment on Medicare claims subject to the following provisions: (1) Coinsurance shall be paid at the lesser of: (a) 100 percent of the coinsurance amount; or (b) The balance remaining after the Medicare payment is subtracted from the Medicaid rate. G. The Program may not make a direct payment to a recipient. H. Billing time limitations are those set forth in COMAR 10.09.36.06. I. The provider may not bill the Program or recipient for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Services rendered by mail or telephone; and (4) Providing a copy of a recipient’s medical record when requested by another licensed provider on behalf of the recipient. J. The portable X-ray provider shall identify the individual who ordered the portable X-ray services by recording the individual practitioner’s National Provider Identifier (NPI) number on the claim. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.88.08* General policies governing recovery and reimbursement procedures that are applicable to all providers are set forth in COMAR 10.09.36.07 #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.88.09* General policies governing the cause for suspension and removal and imposition of sanctions procedures that are applicable to all providers are set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.88.10* General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09. ### Chapter 89 — 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families **Authority:** Health-General Article, §2-104(b), Annotated Code of Maryland **Administrative History:** Effective date: October 1, 2014 (41:19 Md. R. 1077) **Administrative History:** Regulation .15B amended effective July 4, 2016 (43:13 Md. R. 712) **Administrative History:** Regulation .10F amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) **Administrative History:** Regulation .11E amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) **Administrative History:** Regulation .12C amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) **Administrative History:** Regulation .13D amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) **Administrative History:** Regulation .14F amended October 24, 2016 (43:21 Md. R. 1166); January 15, 2018 (45:1 Md. R. 13) **Administrative History:** Chapter revised effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .02B amended effective June 14, 2021 (48:12 Md. R. 473) **Administrative History:** Regulation .03C, E, H amended effective June 14, 2021 (48:12 Md. R. 473) **Administrative History:** Regulation .04A amended effective June 14, 2021 (48:12 Md. R. 473) **Administrative History:** Regulation .09D, E amended effective November 13, 2023 (50:22 Md. R. 974) **Administrative History:** Regulation .09F amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .09F repealed effective November 13, 2023 (50:22 Md. R. 974) **Administrative History:** Regulation .10C, D amended effective November 13, 2023 (50:22 Md. R. 974) **Administrative History:** Regulation .10E amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .10E repealed effective November 13, 2023 (50:22 Md. R. 974) **Administrative History:** Regulation .11C amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .11C repealed effective November 13, 2023 (50:22 Md. R. 974) **Administrative History:** Regulation .12F amended effective May 18, 2020 (47:10 Md. R. 517); June 14, 2021 (48:12 Md. R. 473); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .12F repealed effective November 13, 2023 (50:22 Md. R. 974) **Administrative History:** Regulation .14 amended effective September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .14E—I adopted effective November 13, 2023 (50:22 Md. R. 974) #### Regulation .01 Scope. *COMAR 10.09.89.01* The purpose of this chapter is to implement a home and community-based services benefit for children and youth with serious emotional disturbances (SED) and their families, authorized under a 1915(i) Medicaid State Plan Amendment. Eligible participants are served by care coordination organizations through a care coordination service delivery model that utilizes child and family teams to create and implement individualized plans of care that are driven by the strengths and needs of the participants and their families. #### Regulation .02 Definitions. *COMAR 10.09.89.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “1915(c)” means a federal waiver that allows states to provide home- and community-based care to individuals who would otherwise be institutionalized. (2) “1915(i)” means the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program described in this chapter. (3) “Administrative services organization (ASO)” has the meaning stated in COMAR 10.67.01.01. (4) “Behavioral Health Administration (BHA)” means the Department’s administration, as defined by Health General Article Title XX, Annotated Code of Maryland, or its designee. (5) “Care coordinator” means an individual employed through the care coordination organization that is responsible for providing case management services to 1915(i) participants and families as described in COMAR 10.09.90. (6) “Caregiver” means an individual with responsibility for 24-hour care and supervision of a minor. (7) “Care coordination organization (CCO)” means an entity with a minimum of 3 years of experience providing care coordination services that is approved by the Department to provide case management services to 1915(i) participants and their families, pursuant to COMAR 10.09.90. (8) “Child and family team (CFT)” means a team of individuals selected by the participant and family to work with them to design and implement the plan of care. (9) “Core service agency (CSA)” has the meaning stated in COMAR 10.21.17. (10) “Crisis plan” means a document that is developed by a CFT to address actions that need to be taken in the event that an individual is experiencing a behavioral health crisis, which is included as part of the plan of care. (11) “Department” means the Maryland Department of Health (MDH) or its designee. (12) “Department of Human Services (DHS)” has the meaning stated in Human Services Article, Title 2, Annotated Code of Maryland. (13) “Department of Public Safety and Correctional Services (DPSCS)” has the meaning stated in Correctional Services Article, Title 2, Annotated Code of Maryland. (14) “Diagnostic Criteria (DC) 0-5” means a system for diagnosing mental health and developmental disorders in infants and toddlers. (15) “Expressive and experiential behavioral services” means the use of art, dance, music, equine, horticulture, or drama to accomplish individualized goals as part of the plan of care. (16) “Family” means: (a) One or more parents and children related by blood, marriage, or adoption, and residing in the same household; or (b) A parent substitute or substitutes, including informal and formal kinship caregivers as set forth in Health-General Article, §20-105, Annotated Code of Maryland, and Education Article, §7-101, Annotated Code of Maryland, or legal guardians, who have responsibility for the 24 hour care and supervision of a child. (17) “Family peer support” means a service as described in Regulation .09 of this chapter. (18) “Family peer support partner” means an individual providing family peer-to-peer support services. (19) “Family support organization (FSO)” means an approved entity under Regulation .09D of this chapter. (20) “Institution for mental disease (IMD)” has the meaning stated in COMAR 10.67.01.01B. (21) “Local departments of social services (DSS)” has the meaning stated in Human Services Article, Title 3, Annotated Code of Maryland. (22) “Maryland Children’s Health Program (MCHP)” has the meaning stated in COMAR 10.09.43. (23) “Medical Assistance Program” has the meaning stated in COMAR 10.67.02. (24) “Mental health professional” has the meaning stated in COMAR 10.21.17.02. (25) “Natural support” means a family member, friend, or community member, or organization selected by the participant or family, or both, to participate on the CFT. (26) “Participant” means an individual who meets the qualifications, as specified in Regulation .03 of this chapter, for benefit eligibility. (27) “Plan of care (POC)” means a written document that is: (a) Developed by the CFT that describes the services to be provided to the participant; and (b) Approved by the Department in accordance with 42 CFR §441.301. (28) “Program” means the Maryland Medical Assistance Program. (29) “Provider” means an individual or entity that has enrolled with the Program to provide one or more benefit services covered under this chapter. (30) “Public mental health system” means the system for the delivery of mental health treatment and supports to eligible individuals as described in COMAR 10.67.08. (31) “Residential treatment center” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. (32) “Room and board” means rent or mortgage, utilities, maintenance, furnishings, and food provided in or associated with an individual’s place of residence. (33) “Respite care” has the meaning stated in COMAR 10.21.27. (34) “Serious emotional disturbance (SED)” has the meaning stated in COMAR 10.21.17. (35) “Service area” means, during the phase-in of the 1915(i), the geographic area in Maryland where the 1915(i) is available. (36) “State Plan” means the Plan described in §1902(a) of Title XIX of the Social Security Act. (37) “Supplemental Security Income (SSI)” means a federally administered program providing benefits to needy aged, blind, and disabled individuals under Title XVI of the Social Security Act, 42 U.S.C. §1381 et seq. #### Regulation .03 Participant Eligibility. *COMAR 10.09.89.03* A. For an applicant to be eligible for 1915(i) services, the applicant shall meet all of the criteria in §§B—H of this regulation. B. The applicant shall be younger than 18 years old at the time of enrollment. C. The applicant shall reside in a home- and community-based setting that is: (1) Located in the 1915(i) service area; and (2) Not any of the following excluded settings: (a) Therapeutic Group Home (TGH) licensed by the Behavioral Health Administration (BHA) under COMAR 10.21.07; (b) Psychiatric Respite Care facility located on the grounds of an institution for mental disease (IMD) for the purpose of placement; (c) Residential program for adults with serious mental illness licensed under COMAR 10.63; or (d) Group residential facility licensed under COMAR 10.63. D. Consent. (1) For individuals younger than 16 years old, the family or medical guardian of the participant shall give consent for the individual to participate in the 1915(i); (2) For individuals 16 years old or older, the individual shall give consent to participate in the 1915(i). E. The applicant shall: (1) Have a face-to-face psychosocial assessment completed or updated within 30 days of submission of the enrollment to the ASO that: (a) Assigns a Diagnostic and Statistical Manual (DSM) behavioral health diagnosis or Diagnostic Criteria (DC) 0-5 diagnosis; (b) Determines the applicant to be amenable to active clinical treatment; and (c) Is conducted by a provider not associated with the CCO by which the participant may eventually be served; and (2) Meet the Department’s written medical necessity criteria. F. The accessibility or intensity of currently available community supports and services are inadequate to meet the applicant’s needs due to the severity of the impairment without the provision of one or more of the services contained in the 1915(i) benefit. G. The applicant may not be served in a Health Home as defined in COMAR 10.09.33 while enrolled in the 1915(i). H. Medical Assistance Eligibility. (1) Categorically Needy. An applicant is eligible for 1915(i) services if the applicant is eligible for Medicaid or Maryland Children’s Health Program (MCHP) in accordance with COMAR 10.09.11 or 10.09.24 and has a family income that does not exceed 300 percent of the Federal Poverty Line (FPL). (2) Optional Categorically Needy. An applicant is eligible for the 1915(i) benefit as optionally categorically needy in accordance with §1902(a)(10)(A)(ii)(XXII) if the individual is receiving services through an existing 1915(c) HCBS waiver program. I. The Department may assist applicants in the benefit application process by: (1) Informing the applicant and family verbally and in writing about services available in the 1915(i); (2) Assisting the applicant and family to complete the eligibility determination for Medical Assistance for the 1915(i), if necessary; and (3) Once Medical Assistance eligibility is determined, ensuring that the assessments and documentation required for a medical necessity determination are obtained and provided to the Department. J. Based on the criteria established in §§A—H of this regulation: (1) An applicant’s eligibility for services under this regulation shall be established by the Department; (2) There is no retroactive eligibility; and (3) Benefit eligibility may not begin before: (a) Verification of the applicant’s Medical Assistance eligibility for the 1915(i); and (b) Completion of the independent evaluation by the Department that the applicant meets all criteria established in §§A—H of this regulation. K. If the applicant is determined to meet the needs-based eligibility criteria as established in §§A—H of this regulation, the Department shall: (1) Obtain written consent from the family or medical guardian to participate in the 1915(i); and (2) Ensure that the participant is referred immediately upon enrollment determination to a CCO. L. The Department shall re-evaluate a participant’s: (1) Needs-based eligibility for 1915(i) services as specified in §§A—G of this regulation every 12 months, or more frequently due to a significant change in the participant’s condition or needs, in accordance with the Department’s medical necessity criteria; and (2) Medical Assistance eligibility for 1915(i) services in accordance with the Department’s redetermination policy for all Medical Assistance enrollees. #### Regulation .04 Termination of Participant Enrollment. *COMAR 10.09.89.04* A. A participant shall be disenrolled from the 1915(i), as of the date established by the Department, if the participant: (1) No longer meets all of the criteria for 1915(i) eligibility specified in §§A—H of Regulation .03 of this chapter; (2) Voluntarily chooses to disenroll from the benefit, if the participant is 18 years old, or the participant’s family or medical guardian chooses to do so on behalf of a participant who is younger than 18 years old or in the custody of the State, or both; (3) Is hospitalized for longer than 30 days; (4) Moves out of the service area and cannot reasonably access services and supports; (5) Is admitted to and placed in an RTC for longer than 60 days; (6) Is admitted to and placed in a Therapeutic Group Home (TGH) licensed by BHA under COMAR 10.21.07 or an adult residential program approved under COMAR 10.21.22; (7) Is placed in a Psychiatric Respite Care program, a non-medical group residential facility located on the grounds of an IMD primarily for the purpose of placement; (8) Loses eligibility for Maryland Medical Assistance; (9) Turns 22 years old; (10) Is detained, committed to a juvenile justice or correctional facility, or incarcerated for longer than 60 days; (11) Does not meet medical re-certification criteria; (12) Does not participate in a Child and Family Team (CFT) meeting within 90 days; (13) Is no longer actively engaged in ongoing behavioral health treatment with a licensed mental health professional; or (14) Is placed in a group residential facility licensed under COMAR 14.31.05—.07. B. A participant who is not receiving 1915(i) services continuously after reaching age 18 is ineligible to enroll in the program at a later date. #### Regulation .05 1915(i) Model. *COMAR 10.09.89.05* A. The 1915(i) shall provide community-based treatment to children with SED or co-occurring diagnosis through the care coordination model. B. Enrollment in 1915(i) services qualifies and requires the participant to receive case management services through a CCO, pursuant to COMAR 10.09.90. C. Each participant shall have an individualized POC that is managed by the CCO, pursuant to COMAR 10.09.90: D. In partnership with the CFT, the CCO shall: (1) Reevaluate the POC at least every 45 days with re-administration of BHA-approved assessments as appropriate, and more frequently in response to a crisis; (2) Determine the family vision, which will guide the planning process; (3) Identify strengths of the entire team; (4) Determine the needs that the team will work on; (5) Determine outcome statements for meeting identified needs; (6) Determine the specific services and supports required in order to achieve the goals identified in the POC; (7) Create a mission statement that the team generates and commits to following; (8) Identify the individuals responsible for each of the strategies in the POC; (9) Review and update the crisis plan; and (10) Meet at least every 45 days or more frequently as clinically indicated to: (a) Coordinate the implementation of the POC; and (b) Re-evaluate and update the POC as necessary. E. Benefit participants shall have access to specialty behavioral health services through the Department’s public behavioral health system. Participants shall also be enrolled in the Medical Assistance Program’s managed care program, known as HealthChoice, in accordance with eligibility requirements set forth in COMAR 10.67.02. #### Regulation .06 Conditions for Provider Participation. *COMAR 10.09.89.06* A. The Department shall grant approval to providers to be eligible to receive Medicaid funds for 1915(i) services if the provider meets the requirements set forth in this chapter. B. Application. To provide 1915(i) services, a provider applicant shall: (1) Submit an application to the Department on the form approved by the Department, with all questions answered and all required documents attached; and (2) Attest that the provider applicant is in compliance with the general provider requirements and specific 1915(i) service requirements set forth in this chapter and in COMAR 10.09.36. C. Application Modification. (1) A provider that proposes to change its 1915(i) service sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department. (2) If the Department approves the application modification, the existing provider approval shall extend to the additional site, as applicable. D. Approval. (1) The Department may grant approval to an applicant provider if the Department determines that the provider: (a) Has no deficiencies that constitute a threat to the health, safety, or welfare of the individuals served; and (b) Attests that it complies with the requirements set forth in this chapter. (2) If the provider is granted approval under §D(1) of this regulation, to continue to be approved, the provider shall maintain documentation of compliance with the requirements set forth in this chapter. E. Sale or Transfer of Approval. (1) The Department’s approval of a 1915(i) service provider is valid only for the provider to which the Department grants approval. (2) A provider may not sell, assign, or transfer approval to another provider. #### Regulation .07 Denial, Emergency Suspension of Approval, and Disciplinary Action. *COMAR 10.09.89.07* A. Denial of Approval. (1) If the Department proposes to deny approval to an applicant under the provisions of this chapter, the Department shall give written notice of the proposed denial to the: (a) Provider applicant; (b) Care coordination organization (CCO); and (c) Administrative service organization (ASO). (2) In the notice under §A(1) of this regulation, the Department shall include: (a) The date on which the Department proposes to deny approval; (b) The facts that warrant the proposed denial of approval; (c) Citation of the regulation or regulations upon which the proposed denial is based; (d) Notification that before the denial of approval, the provider may request a hearing under the provisions of COMAR 10.21.16; and (e) When feasible, notification of a case resolution conference. B. Disciplinary Action. (1) The Department may propose to take any of the following disciplinary actions against a provider: (a) Revocation of approval; (b) Suspension of approval; (c) Probation with conditions; or (d) Banning new admissions. (2) The Department may propose to take one of the actions outlined in §B(1) of this regulation if the provider: (a) Is out of compliance with the requirements of this chapter; (b) Fails to maintain financial viability; or (c) Obtains or attempts to obtain approval or payment by fraud, misrepresentation, or the submission of false information to the Department. (3) Except under §C of this regulation, the Department shall send written notice of the proposed action not less than 45 calendar days in advance of the proposed action taken under this regulation to the: (a) Provider; (b) CCO; (c) ASO; and (d) Applicable CSA. (4) In the notice under §B(3) of this regulation, the Department shall include: (a) The date on which the Department proposes to take action and, when feasible, the date of a case resolution conference; (b) The facts that warrant the proposed action; (c) Citation of the regulation or regulations upon which the proposed action is based; and (d) Notification that, before the action, the provider has the right to request a hearing under the provisions of COMAR 10.21.16. (5) If, after notice and opportunity to be heard, the Department takes disciplinary action, the provider shall, within 10 working days: (a) Notify individuals or the guardians of individuals receiving services of the action; and (b) If the program ceases operations: (i) Notify individuals or the guardians of individuals receiving services of the suspension; and (ii) Cooperate with the CCO, child and family team, and the Department in accessing appropriate alternate services for individuals served by the provider. C. Emergency Suspension of Approval. (1) Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a provider, the Department may order the immediate suspension of the approval of the provider and the cessation of operation. (2) If the Department takes the action under §C(1) of this regulation, the Department shall promptly give written notice of the proposed emergency suspension to the: (a) Provider; (b) CCO; (c) ASO; and, (d) Applicable CSA. (3) In the notice under §C(2) of this regulation, the Department shall include: (a) The proposed effective date of the emergency suspension; (b) When feasible, the date of a pre-deprivation hearing and a case resolution conference before the Department’s final action; (c) The findings under §C(1) of this regulation and the reasons that support the findings; and (d) Notification that: (i) Following the emergency suspension, the provider may request a hearing under the provisions of COMAR 10.21.16; and (ii) The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department. (4) If the Department suspends approval, the provider shall immediately: (a) Notify individuals or the guardians of individuals receiving services of the suspension; (b) Cooperate with the CCO, child and family team, and the Department in accessing appropriate alternate services for individuals in the program; and (c) Cease operations of the program. #### Regulation .08 General Conditions for 1915(i) Services Provider Participation. *COMAR 10.09.89.08* A. A provider of 1915(i) services shall: (1) Provide the documentation required by the Department for initial approval and provider recertification, or as requested by the Department; (2) Be approved by the Department as meeting the requirements of being able to provide the services set forth in this chapter; (3) Have a provider agreement in effect, to include adherence to quality assurance, auditing, and monitoring policies and procedures; (4) Receive training and certification as required and approved by the Department and determined to be appropriate for the level and scope of services provided; (5) Meet all the conditions for participation in COMAR 10.09.36 except as otherwise specified in this chapter; (6) Maintain general liability insurance, and provide proof of this insurance: (a) At the time of initial application to be a provider of 1915(i) services; (b) At recertification; and (c) Upon request by the Department; (7) Make available to the Department and federal funding agents all records for inspection and copying, including but not limited to: (a) Personnel files for each individual employed, regardless of method of compensation; (b) Financial records; (c) Treatment records; and (d) Service records; (8) Comply with the following prohibitions against utilization of staff: (a) Unless waived by the Department in accordance with §D of this regulation, prohibit from working with the participant or the participant’s family any staff, volunteers, students, or any individual who is: (i) Convicted of, received probation before judgment, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft; or (ii) Has an indicated finding of child abuse or neglect; and (9) Maintain administrative and medical records documenting the date, time, duration, and substantive notes associated with the services delivered, which shall be signed by the provider and indicated by the participant’s plan of care. B. Required Criminal Background Checks. The provider shall, at the provider’s own expense and for all staff, volunteers, students, and any individual providing services to participants and their families in the 1915(i): (1) Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland; (2) Request that DPSCS send the report to: (a) The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or (b) To the Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency; and (3) Review the results of the background checks; (4) Store background checks in a secure manner consistent with State and federal law; and (5) Maintain written documentation in the individual’s personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation. C. Required Check for Abuse or Neglect. For each individual providing services to participants and the participant’s families in the 1915(i), the provider shall: (1) Before employing any individual, submit a notarized Consent for Release of Information/Background Clearance Request form to the Department of Human Services (DHS) or a local department of social services (DSS) in the jurisdiction in which the individual lives, pursuant to COMAR 07.02.07.19; and (2) Request that DHS or the local DSS send the report to: (a) The director of the agency if the request is from a provider agency concerning staff, volunteers, or students who will work with the participant or family; or (b) To the Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency. D. To provide 1915(i) services, an individual may not: (1) Be the participant’s family member; (2) Have been convicted of, received probation before judgment for, or entered a plea of nolo contendere to, a felony or any crime involving moral turpitude or theft, or have any other criminal history that indicates behavior which is potentially harmful to participants; or (3) Be cited on any professional licensing or certification boards or any other registries with a determination of abuse, misappropriation of property, financial exploitation, or neglect. E. Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant’s family if the provider submits a request to the Department together with the following documentation that: (1) For criminal background checks: (a) The conviction, the probation before judgment, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application; (b) The criminal history does not indicate behavior that is potentially harmful to participants; and (c) Includes a statement from the individual as to the reasons the prohibition should be waived; and (2) For abuse and neglect findings: (a) The indicated finding occurred more than 7 years before the date of the clearance request; (b) The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant’s family; and (c) Includes a statement from the individual as to the reasons the prohibition should be waived. F. The Program covers the services listed in this chapter when the services are: (1) Determined by the Department to be medically necessary; (2) Preauthorized by Department; and (3) Delivered in accordance with the participant’s POC. #### Regulation .09 Covered Services — Family Peer Support Services. *COMAR 10.09.89.09* Family peer support services: A. May be provided without the presence of the participant; B. Are delivered by a family peer support partner employed by a family support organization (FSO); C. May include, but are not limited to: (1) Explaining the role and function of the FSO to newly enrolled families and creating linkages to other peers and supports in the community; (2) Working with the participant and family to identify and articulate concerns, needs, and vision for the future of the participant; (3) Ensuring family and participant opinions and perspectives are incorporated into the CFT process and POC: (a) Through communication with the care coordinator and team members; and (b) By attending CFT meetings with the family to support family decision-making and choice of options; (4) Listening to the family express needs and concerns and offering suggestions for engagement in the treatment process; (5) Helping the family identify and engage its own natural support system and facilitating the family attending peer support groups and other FSO activities throughout the POC process; (6) Working with the family: (a) To organize and prepare for meetings in order to maximize participation in meetings; (b) By informing the family about options and possible outcomes in selecting services and supports to assist with informed decision-making; and (c) By supporting the family in meetings at school and other locations in the community and during court hearings; (7) Empowering the family to make choices to achieve desired outcomes for the participant as well as the entire family; and (8) Helping the family to acquire the skills and knowledge needed to attain greater self-sufficiency and maximum autonomy and assisting the family to develop the skills and confidence to independently identify, seek out and access resources that will assist in: (a) Managing and mitigating the participant's behavioral health condition or conditions; (b) Preventing the development of secondary or other chronic conditions; (c) Promoting optimal physical and behavioral health; and (d) Addressing and encouraging activities related to health and wellness. D. Are provided by a family support organization (FSO) that: (1) Is designated as a private, nonprofit entity designated under §501(c)(3) of the Internal Revenue Service Code, and submits copies of the certificate of incorporation and Internal Revenue Service designation; (2) Has a board of directors comprised of more than 50 percent of individuals who are: (a) Caregivers with a current or previous primary daily responsibility for raising a child or youth with behavioral health challenges, (b) Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; or (c) Both §D(2)(a) and (b) of this regulation. (3) Submits a list of board members with identification of those who are caregivers meeting the criteria in §D(2)(b) of this regulation; (4) Establishes hiring practices that give preference to: (a) Current or previous caregivers of a child or youth with behavioral health challenges; (b) Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; or (c) Both §D(4)(a) and (b) of this regulation; (5) Submits a copy of the organization's personnel policy that sets forth the preferred employment criteria stated in §D(4) of this regulation; (6) Employs a staff that is comprised of at least 75 percent of individuals who are: (a) Current or previous caregivers of a child or youth with behavioral health challenges; or (b) Individuals who have experience with State or local services and systems as a consumer who has or had behavioral health challenges; (7) Submits a list of staff and positions held with identification of those who fit the experienced caregiver and consumer criteria stated in §D(6) of this regulation; and (8) Submits a certificate of eligibility that includes: (a) Attestation of compliance with §D(1)—(6) of this regulation; and (b) The organization’s mission statement that establishes the purpose of the organization as providing support and education to youth with emotional, behavioral, or mental health challenges and their caregivers; and E. Shall be provided by family peer support partners who: (1) Are employed by an FSO; (2) Are 18 years old or older; (3) Receive supervision from an individual who: (a) Is 21 years old or older; and (b) Has at least 3 years of experience providing family peer-to-peer support or working with children with serious behavioral health challenges and their families; (4) Have current or prior experience as a caregiver of a child with behavioral health challenges or be an individual who has experience with State or local services and systems as a consumer who has or had behavioral health challenges; and (5) Receive training and certification as approved by the Department. #### Regulation .10 Covered Services — Respite Services. *COMAR 10.09.89.10* Respite services: A. Include a set of specific short-term services documented in the POC that include: (1) A schedule of the participant's activities during respite; (2) Medication monitoring, if needed; (3) The frequency, duration, and intensity of staff support; (4) Respite locations; and (5) The aftercare plan or recommendations; B. Include community-based respite services, which are provided in the participant's home or other community-based setting; C. Include out-of-home respite services, which provide a temporary overnight living arrangement outside of the participant’s home; and D. Are provided by organizations that shall: (1) Meet the requirements of COMAR 10.63.03.15; (2) Employ respite care specialists who are: (a) 21 years old or older and have a high school diploma or high school equivalency; or (b) At least 18 years old and enrolled in, or in possession of at least an associate degree from, an accredited college or university in a human services field, and are limited to providing services to participants under 13 years of age; (3) Ensure that community-based respite services are provided in the participant's home or other community-based setting; and (4) Ensure that out-of-home respite services are: (a) Provided in a community-based temporary overnight living arrangement outside the participant's home; and (b) Where applicable, delivered in accordance with COMAR 14.31.05—14.31.07. #### Regulation .11 Covered Services — Expressive and Experiential Behavioral Services. *COMAR 10.09.89.11* A. Expressive and experiential behavioral services: (1) May be provided to an individual or group; (2) Provide sensory modalities to participants to assist in achieving POC objectives; and (3) Include: (a) Art behavioral services; (b) Dance behavioral services; (c) Equine-assisted behavioral services; (d) Horticultural behavioral services; (e) Music behavioral services; or (f) Drama behavioral services. B. Qualification to Provide Expressive and Experiential Behavioral Services. (1) To provide expressive and experiential behavioral services, an individual shall have: (a) A bachelor's or master's degree from an accredited college or university; and (b) Current registration in the applicable association as outlined in §E(5) of this regulation; (2) Association Registration. (a) Art Behavioral Services. To provide art behavioral services, an individual shall be currently registered as a registered art therapist by: (i) The Art Therapy Credentials Board in the American Art Therapy Association; or (ii) A comparable association with equivalent requirements. (b) For Dance Behavioral Services. To provide dance behavioral services, an individual shall be currently registered as a dance therapist registered, or an academy of dance therapists registered in: (i) The American Dance Therapy Association; or (ii) A comparable association with equivalent requirements. (c) For Equine-Assisted Behavioral Services. To provide equine-assisted behavioral services, an individual shall be currently certified by: (i) The Equine Assisted Growth and Learning Association (EAGALA) to provide services under the EAGALA model; (ii) Professional Association of Therapeutic Horsemanship International (PATHI); or (iii) A comparable association with certification requirements at least equivalent to EAGALA or PATHI. (d) For Horticultural Behavioral Services. To provide horticultural behavioral services, an individual shall be currently registered as a horticultural therapist registered in: (i) The American Horticultural Therapy Association; or (ii) A comparable association with equivalent requirements. (e) For Music Behavioral Services. To provide music behavioral services, an individual shall be currently registered as a music therapist-board certified by: (i) The Certification Board for Music Therapists, Inc; or (ii) A comparable association with equivalent requirements. (f) For Drama Behavioral Services. To provide psychodrama/drama behavioral services, an individual shall be currently registered as a registered drama therapist or a board certified trainer in: (i) The National Association for Drama Therapy; or (ii) A comparable association with equivalent requirements. #### Regulation .12 Covered Services — Intensive In-Home Services. *COMAR 10.09.89.12* A. Intensive In-Home Services (IIHS): (1) Are strengths-based interventions with the child and his or her identified family that includes a series of components, such as: (a) Functional assessments and treatment planning; (b) Individualized interventions; (c) Crisis response and intervention; or (d) Transition support; (2) May be provided to the child alone, to other family members, or to the child and family members together; (3) Are intended to support a child to remain in his or her home and reduce hospitalizations and out-of-home placements or changes of living arrangements through focused intervention in the home and community; and (4) May be used in situations such as the start of a child's enrollment in the 1915(i), upon discharge from a hospital or residential treatment center, or to prevent or stabilize after a crisis situation. B. Types of IIHS Providers. The Department may approve two types of IIHS providers: (1) Evidence-Based Practice (EBP)-IIHS providers, to include providers of EBPs as determined by the Department; and (2) Promising Practice IIHS providers (non-EBP), to include providers of the In-Home Intervention Program for Children (IHIP-C) and other promising practices, as determined by the Department. C. An EBP-IIHS provider shall have a certificate or letter from the national or intermediate surveyor or developer of the particular evidence-based practice to demonstrate that the EBP-IIHS provider meets all requirements for Department-approved EBP-IIHS, to include participating in all fidelity monitoring activities. D. A Non-EBP IIHS provider shall: (1) Be a Department-approved IHIP-C provider or have a certificate or letter from a national or intermediate purveyor or developer of another promising practice; and (2) Meet the requirements of §E of this regulation. E. All non-EBP IIHS providers not approved by the Department as IHIP-C providers shall: (1) Ensure that there are Clinical Supervisors and staff who are responsible for creating, implementing, and managing the treatment plan with the child and family and the CFT; (2) Provide crisis response services for the participants on the IIHS provider's caseload and ensure that on-call and crisis intervention services are: (a) Provided by a licensed mental health professional trained in the intervention; (b) Available 24-hours per day, 7 days per week, during the hours the provider is not open to the individual enrolled in the treatment; and (c) In compliance with staffing, supervision, training, data collection, and fidelity monitoring requirements set forth by the purveyor, developer, or MDH and approved by the Department; (3) Employ Clinical Supervisors who: (a) Have a current license under the Health Occupations Article, Annotated Code of Maryland, as a: (i) Licensed certified social worker-clinical (LCSW-C); (ii) Licensed clinical professional counselor (LCPC); (iii) Psychologist; (iv) Psychiatrist; (v) Nurse psychotherapist; or (vi) Advanced practice registered nurse/psychiatric mental health (APRN-PMH); and (b) Have at least 3 years of experience in providing mental health treatment to children and families; (4) Employ mental health professionals who: (a) Have a current license under the Health Occupations Article, Annotated Code of Maryland, as a: (i) Licensed certified social worker (LCSW); (ii) LCSW-C; (iii) LCPC; (iv) Psychologist; (v) Psychiatrist; (vi) Nurse psychotherapist; or (vii) APRN-PMH. (b) Are supervised by a clinical lead supervisor; (c) See the child in-person at least once per 7 days while receiving IIHS services; (5) Employ in-home stabilizers who: (a) Support the implementation of the treatment plan, but are not responsible for creating it or modifying it; (b) Are at least 21 years old; (c) Have at least a high school diploma or equivalency; and (d) Have completed relevant, comprehensive, appropriate training before providing services, as outlined by the purveyor, developer, or the Department and approved by the Department; (6) Provide a minimum of one face-to-face contact with the participant per week of service; (7) Ensure a minimum of 50 percent of the mental health professionals' contacts with the participant or family, or both, is face-to-face; and (8) Ensure that a minimum of 50 percent of the mental health professionals' time is spent working outside the agency's office and in the participant's home or community, as documented in case notes. #### Regulation .13 Limitations. *COMAR 10.09.89.13* A. Reimbursement shall be made by the Program only when all of the requirements of this chapter are met. B. The Program may not reimburse for: (1) Services that are: (a) Provided by a member of the recipient’s immediate family or an individual who resides in the recipient’s home; (b) Not preauthorized by the Department; (c) Not medically necessary; (d) Beyond the provider’s scope of practice; (e) Not appropriately documented; (f) Part of another service paid for by the State; or (g) Provided without a valid required license or appropriate credentials as specified in this chapter; (2) Completion of forms or reports; (3) Broken or missed appointments; (4) Time spent in travel by the provider to and from site of service, except when with the participant or the participant’s family; or (5) Costs of travel by the provider to and from the site of service. C. The Program may not reimburse more than the following: (1) 1 session per day for out-of-home respite; (2) 6 hours per day of community-based respite; (3) 24 overnight units of respite annually; (4) 2 types per day of expressive and experiential behavioral services; or (5) 1 MCRS assessment for the development of the initial crisis plan. D. Intensive in-home services may not be reimbursed for the same day of service or on the same day of service as: (1) Partial hospitalization/day treatment; (2) Mobile crisis response services; or (3) Other family therapies. E. Out-of-home respite and community-based respite services may not be reimbursed for the same day of service or on the same day of service as: (1) Residential rehabilitation; (2) Therapeutic behavioral services; or (3) Any other public mental health system respite services. F. Out-of-home respite and community-based respite services do not include on-going day care or before or after school programs. G. Out-of-home respite and community based respite services may not be delivered to youth residing in Treatment Foster Care. H. No more than 25 percent of the family support organization’s claims in a 30-day period for family peer support may be telephonic for a participant or the participant’s family. #### Regulation .14 Payment Procedures. *COMAR 10.09.89.14* A. Request for Payment. (1) An approved provider shall submit requests for payment for the services covered under this chapter according to the procedures set forth in COMAR 10.09.36.04. (2) The provider shall: (a) Bill the ASO in accordance with the payment methodology specified in this chapter; (b) Accept payment from the ASO as payment in full for the covered services rendered, and make no additional charge to the participant or any other party for these services; and (c) Submit a request for payment in a manner approved by the Program, which includes a certification of the: (i) Date or dates of service; (ii) Participant's name and Medicaid number; (iii) Provider's name, location, and provider identification number; (iv) Type, procedure code or codes, and unit or units of covered services provided; and (v) Amount of reimbursement requested. B. Documentation Required. (1) Payments by the Program or its designee may be withheld or recovered if the provider fails to submit: (a) Requested evidence of services provided; (b) Staff qualifications; (c) Corrective action plans; or (d) Any other types of documentation related to ensuring the health and safety of a participant. (2) Payments shall be released upon receipt and approval by the Program or its designee of the requested documentation. (3) An appeal by the provider under COMAR 10.01.03 does not stay the withholding of payments. C. Billing time limitations for the services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. D. Payments. (1) Payments shall be made only for services rendered by a 1915(i) provider approved by the Department and enrolled as a Medicaid provider. (2) Services will only be paid when delivered in accordance with the POC that has been authorized by the Department. (3) The Program shall pay according to the fee-for-service schedule for each of the covered services, as set forth in this regulation. E. Family peer support services as described in Regulation .09 of this chapter shall be reimbursed at the following rates: (1) For dates of service from July 1, 2022 through June 30, 2023: (a) $21.65 per 15-minute unit for face-to-face services; or (b) $10.82 per 15-minute unit for telephonic or other non-face-to-face activities. (2) Effective July 1, 2023: (a) $22.30 per 15-minute unit for face-to-face services; or (b) $11.84 per 15-minute unit for telephonic or other non-face-to-face activities. F. Respite services as described in Regulation .10 of this chapter shall be reimbursed at the following rates: (1) July 1, 2022 through June 30, 2023: (a) $34.12 per 1-hour unit of service for community-based respite services; or (b) $270.46 per unit of out-of-home respite care. (2) Effective July 1, 2023: (a) $35.14 per 1-hour unit of service for community-based respite services; or (b) $278.57 per unit of out-of-home respite care. G. Expressive and experiential behavioral services as described in Regulation .11 of this chapter, when provided by a licensed mental health professional, shall be reimbursed at the following rates: (1) For dates of service from July 1, 2022 through June 30, 2023 (a) For individual therapy: (i) $92.77 per 45—50-minute session; or (ii) $121.55 per 75—80-minute session; and (b) For group therapy: (i) $36.87 per 45—60-minute session; or (ii) $47.95 per prolonged (75—90-minute) session. (2) Effective July 1, 2023: (a) For individual therapy: (i) $95.55 per 45—50-minute session; or (ii) $125.20 per 75—80-minute session; and (b) For group therapy: (i) $37.98 per 45—60-minute session; or (ii) $49.39 per prolonged (75—90-minute) session. H. Expressive and experiential behavioral services as described in Regulation .11 of this chapter, when provided by a non-licensed mental health professional, shall be reimbursed at the following rates: (1) For dates of service from July 1, 2022 through June 30, 2023: (a) For individual therapy: (i) $84.33 per 45-minute session; or (ii) $109.64 per 75—80-minute session; and (b) For group therapy: (i) $32.78 per 45—60-minute session; or (ii) $42.59 per prolonged (75—90-minute) session. (2) Effective July 1, 2023: (a) For individual therapy: (i) $86.86 per 45-minute session; or (ii) $112.93 per 75—80-minute session; and (b) For group therapy: (i) $33.76 per 45—60-minute session; or (ii) $43.87 per prolonged (75—90-minute) session. I. Intensive in-home services as described in Regulation .12 of this chapter shall be reimbursed at the following rates: (1) For dates of service from July 1, 2022 through June 30, 2023: (a) $337.54 per week of service for EBP-IIHS providers; or (b) $267.78 per week of service for non-EBP IIHS providers. (2) Effective July 1, 2023: (a) $347.67 per week of service for EBP-IIHS providers; or (b) $275.81 per week of service for non-EBP IIHS providers. #### Regulation .15 Recovery and Reimbursements. *COMAR 10.09.89.15* Recovery and reimbursement are set forth in COMAR 10.09.36.07. #### Regulation .16 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.89.16* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08 and 10.21.10. #### Regulation .17 Appeal Procedures for Providers. *COMAR 10.09.89.17* Appeal procedures for providers are those set forth in COMAR 10.09.36.09. #### Regulation .18 Appeal Procedures for Applicants and Participants. *COMAR 10.09.89.18* Appeal procedures for applicants and participants are those set forth in COMAR 10.01.04, 10.09.24.13, and 10.09.70. ### Chapter 90 — Mental Health Case Management: Care Coordination for Children and Youth **Authority:** Health-General Article, §2-104(b), Annotated Code of Maryland **Administrative History:** Effective date: October 1, 2014 (41:19 Md. R. 1078) **Administrative History:** Regulation .02B amended effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .03B amended effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .07 amended effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .07C amended effective November 14, 2022 (49:23 Md. R. 996) **Administrative History:** Regulation .09B amended effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .12A amended effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .13D amended effective August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .16D amended effective April 13, 2015 (42:7 Md. R. 568) #### Regulation .01 Scope. *COMAR 10.09.90.01* A. This chapter applies to providers organized to deliver mental health case management services for children and youth. B. The purpose of mental health case management care coordination is to assist participants in gaining access to needed medical, mental health, social, educational, and other services. #### Regulation .02 Definitions. *COMAR 10.09.90.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “1915(i)” means the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program defined in COMAR 10.09.89. (2) “Care coordination” means services which assist participants in gaining access to a full range of behavioral health services and, as necessary, any medical, social, financial assistance, counseling, educational, housing, and other support services. (3) “Care coordination organization (CCO)” means an entity with a minimum of 3 years of experience providing care coordination services that: (a) Are approved by the Department under this chapter; and (b) Meet the requirements of COMAR 10.09.89 to provide care coordination to participants in the 1915(i) Intensive Behavioral Health Services for Children, Youth, and Families program. (4) “Care coordinator” means an individual employed through the care coordination organization who is responsible for providing care management services to benefit participants and families, including, but not limited to: (a) Coordination of child and family team meetings; and (b) Completion of the initial and revised plan of care. (5) “Child and family team (CFT)” means the group of individuals, including both formal and informal supports and inclusive of the youth and the youth’s family, responsible for the creation and implementation of the plan of care. (6) “Co-occurring disorder” means a diagnosis based on the current Diagnostic and Statistical Manual published by the American Psychiatric Association where the participant is indicated as having both a mental illness and substance use disorder. (7) “Core service agency” has the meaning stated in COMAR 10.21.17. (8) “Department” has the meaning stated in COMAR 10.09.36.01 and refers to the Department or its designee. (9) “Medical Assistance Program” has the meaning stated in COMAR 10.09.36.01. (10) “Mental Health Case Management: Care Coordination for Children and Youth” has the same meaning as “care coordination” as defined in this regulation. (11) “Mental health professional” has the meaning stated in COMAR 10.21.17.02. (12) “Mental health services” means those services described in COMAR 10.09.70. (13) “Minor” means a child or adolescent younger than 16 years old. (14) “Natural supports” means any individual who plays a positive, but nonprofessional, role in someone’s plan of care. (15) “Participant” means an individual who meets the qualifications for participation in care coordination that are specified in Regulation .03 of this chapter. (16) “Plan of care (POC)” means the individualized plan for supports and services prepared according to the requirements outlined in this chapter for a specific participant in care coordination, including a POC developed for 1915(i) participants pursuant to COMAR 10.09.89. (17) “Program” has the meaning stated in COMAR 10.09.36.01. (18) “Provider” means the care coordination provider. (19) “Recipient” has the meaning stated in COMAR 10.09.36.01. (20) “Residential treatment center (RTC)” has the meaning stated in COMAR 10.07.04. (21) “Serious emotional disturbance (SED)” has the meaning stated in COMAR 10.21.17.02. (22) “Young adult” means an individual who is 18 years old or older but not older than 21 years old. #### Regulation .03 Participant Eligibility. *COMAR 10.09.90.03* A. A participant shall be eligible for care coordination services if the recipient: (1) Is in a federal eligibility category for Maryland Medical Assistance according to COMAR 10.09.24, which governs the determination of eligibility for the Maryland Medical Assistance Program; and (2) Meets the criteria of either §B(1) or (2) of this regulation. B. The participant: (1) Shall: (a) Meet the diagnostic requirements of being either: (i) An individual younger than 18 years old with a serious emotional disturbance or co-occurring disorder; or (ii) A young adult with a serious emotional disturbance or co-occurring disorder enrolled in care coordination services continuously under this chapter since reaching age 18; and (b) Require community treatment and support in order to prevent or address: (i) Inpatient psychiatric or substance use treatment; (ii) Treatment in a RTC or residential substance use treatment facility; (iii) An out-of-home placement; (iv) Emergency room utilization due to multiple behavioral health stressors; (v) Homelessness or housing instability, or otherwise lacking in permanent, safe housing; or (vi) Arrest or incarceration due to multiple behavioral health stressors; or (2) Shall: (a) Meet the requirements of §B(1)(a); and (b) Need care coordination services to facilitate community treatment following: (i) Release from a detention center or correctional facility; or (ii) Discharge to the community from RTC placement or inpatient psychiatric unit. C. A participant that disenrolls after reaching 18 years of age and wishes to re-enroll in care coordination services at a later date shall do so pursuant to COMAR 10.09.45 if more than 120 calendar days has passed since disenrollment. #### Regulation .04 Participant Eligibility — Levels of Intensity. *COMAR 10.09.90.04* A. In addition to meeting the eligibility criteria outlined under Regulation .03 of this chapter, participants shall be classified according to the levels of intensity listed in Regulation .05, 06, or .07 of this chapter, based on the severity of the participant’s behavioral health or co-occurring disorder, along with assessed strengths and needs. B. The Department or its designee shall review participant levels of care to confirm these are appropriate to the participants’ needs. C. Participants may not remain at Level III for longer than 6 consecutive months unless approved by the Department or its designee. #### Regulation .05 Participant Eligibility — Level I — General Care Coordination. *COMAR 10.09.90.05* The participant as described in Regulation .03A of this chapter shall meet at least two of the following conditions: A. The participant is not linked to behavioral health, health insurance, or medical services; B. The participant lacks basic supports for education, income, shelter, or food; C. The participant is transitioning from one level of intensity to another level of intensity of services; D. The participant needs care coordination services to obtain and maintain community-based treatment and services; E. The participant: (1) Is currently enrolled in Level II or Level III Care Coordination services under this chapter; and (2) Has stabilized to the point that Level I is most appropriate. #### Regulation .06 Participant Eligibility — Level II — Moderate Care Coordination. *COMAR 10.09.90.06* The participant as described in Regulation .03A of this chapter shall meet three or more of the following conditions: A. The participant is not linked to behavioral health services, health insurance, or medical services; B. The participant lacks basic supports for education, income, food, or transportation; C. The participant is homeless or at-risk for homelessness; D. The participant is transitioning from one level of intensity to another level of intensity including transitions out of the following levels of service: (1) Inpatient psychiatric or substance use services; (2) RTC; or (3) 1915(i) services under COMAR 10.09.89; E. Due to multiple behavioral health stressors within the past 12 months, the participant has a history of: (1) Psychiatric hospitalizations; or (2) Repeated visits or admissions to: (a) Emergency room psychiatric units; (b) Crisis beds; or (c) Inpatient psychiatric units; F. The participant needs care coordination services to obtain and maintain community-based treatment and services; G. The participant: (1) Is currently enrolled in Level III Care Coordination services under this chapter; and (2) Has stabilized to the point that Level II is most appropriate; H. The participant: (1) Is currently enrolled in Level I Care Coordination services under this chapter; and (2) Has experienced one of the following adverse childhood experiences during the preceding 6 months: (a) Emotional, physical, or sexual abuse; (b) Emotional or physical neglect; or (c) Significant family disruption or stressors. #### Regulation .07 Participant Eligibility — Level III — Intensive Care Coordination. *COMAR 10.09.90.07* A. The participant shall meet at least one of the following conditions: (1) The participant has been enrolled in the 1915(i) program for 6 months or less; (2) The participant is currently enrolled in Level I or Level II Care Coordination services under this chapter and has experienced one of the following adverse childhood experiences during the preceding 6 months: (a) Emotional, physical, or sexual abuse; (b) Serious emotional or physical neglect; or (c) Significant family disruption or stressors; (3) The participant meets the following conditions: (a) The participant has a behavioral health disorder amenable to active clinical treatment, diagnosed through a face-to-face psychosocial assessment by a licensed mental health professional; (b) There is clinical evidence the minor has a SED and continues to meet the service intensity needs and medical necessity criteria for the duration of their enrollment; (c) A comprehensive psychosocial assessment performed by a licensed mental health professional finds that the participant exhibits a significant impairment in functioning, representing potential serious harm to self or others, across settings, including the home, school, or community; (d) The psychosocial assessment supports the completion of the Early Childhood Service Intensity Instrument (ECSII) for youth ages 0—5 or the Child and Adolescent Service Intensity Instrument (CASII) for youth ages 6—21, by which the participant receives a score of: (i) 3 on the ECSII; or (ii) 3 or higher on the CASII; (e) Youth with a score of 3, 4, or 5 on the CASII also shall meet the conditions outlined in §B of this regulation; and (f) Youth with a score of 3 or 4 on the ECSII also shall meet the conditions outlined in §C of this regulation. B. Youth with a score of 3, 4, or 5 on the CASII shall meet one of the following criteria to be eligible based on their impaired functioning and service intensity level: (1) Transitioning from a residential treatment center; or (2) Living in the community, be 6 through 21 years old, and have: (a) Any combinations of 2 or more inpatient psychiatric hospitalizations or emergency room visits in the past 12 months; or (b) Been in an RTC within the past 90 calendar days. C. Youth who are younger than 6 years old who have a score of a 3 or 4 on the ECSII shall either: (1) Be referred directly from one of the following: (a) Inpatient or day hospital unit; (b) Primary care physician (PCP); (c) Outpatient psychiatric facility; (d) Early Childhood Mental Health (ECMH) Consultation program in daycare; (e) Head Start program; (f) Judy Hoyer Center; or (g) Home visiting program; or (2) If living in the community, meet one or more of the following criteria in the past 12 months: (a) Had one or more psychiatric inpatient or day hospitalizations; (b) Had one or more ER visits; (c) Exhibit severe aggression; (d) Display dangerous behavior; (e) Been suspended from school or childcare setting; (f) Display emotional or behavioral disturbance prohibiting their care by anyone other than their primary caregiver; (g) Be at risk for out-of-home placement or placement disruption; (h) Have severe temper tantrums that place the child or family members at risk of harm; (i) Have trauma exposures and other adverse life events; or (j) Be at risk of family-related risk factors, including safety, parent-child relational conflict, and poor health and developmental outcomes. #### Regulation .08 Conditions for Provider Participation. *COMAR 10.09.90.08* A. Selection of CCOs. (1) The local core service agencies shall select child and youth CCOs through a competitive procurement process, at least once every 5 years. (2) Regional CCOs may be procured at the mutual agreement of local core service agencies so long as the local core service agencies demonstrate that there is sufficient provider capacity to serve the children and youth in a particular region. B. The CCO shall: (1) Be approved by the Department as a CCO; (2) Commit to coordination with all agencies involved in the participant’s POC; and (3) Work with the State and local child- and family-serving agencies to develop a network of clinical and natural supports in the community to address strengths and needs identified in each POC. C. Required Criminal Background Checks. The provider shall, at the provider’s own expense and for all staff, volunteers, students, and individuals providing care coordination services to participants and their families: (1) Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland; (2) Request that DPSCS send the report to: (a) The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or (b) The Department’s designee, if the provider is a self-employed, independent practitioner, or the director of the agency; (3) Review the results of the background checks; (4) Store background checks in a secure manner consistent with State and federal law; and (5) Maintain written documentation in the individual’s personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation. D. Prohibitions Against Utilization of Staff. Unless waived by the Department in accordance with §E of this regulation, the provider shall prohibit from working with the participant or the participant’s family any staff, volunteers, students, or individuals who: (1) Are convicted of, received probation before judgment for, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft or have any other criminal history that indicates behavior which is potentially harmful to a participant; (2) Are cited on any professional licensing or certification boards or any other registries with a determination of abuse, misappropriation of property, financial exploitation, or neglect; or (3) Have an indicated finding of child abuse or neglect. E. Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant’s family if the provider submits a request to the Department together with the following documentation that: (1) For criminal background checks: (a) The conviction of, the probation before judgment for, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application; (b) The criminal history does not indicate behavior that is potentially harmful to participants; and (c) Includes a statement from the individual as to the reasons the prohibition should be waived; and (2) For abuse and neglect findings: (a) The indicated finding occurred more than 7 years before the date of the clearance request; (b) The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant’s family; and (c) Includes a statement from the individual as to the reasons the prohibition should be waived. F. The CCO shall provide all three levels of care coordination to ensure continuity of care for participants. #### Regulation .09 Conditions for Provider Participation — Eligibility. *COMAR 10.09.90.09* A. General Requirements. To be eligible to be approved as a care coordination organization, an entity shall meet all of the: (1) Conditions for participation as set forth in COMAR 10.09.36.03; and (2) Medical Assistance provisions listed in COMAR designated for their provider type. B. Specific Requirements. A CCO: (1) May not place restrictions on the qualified recipient’s right to elect to or decline to: (a) Receive care coordination as authorized by the Department; and (b) Choose a care coordinator, as approved by the Department, and other care providers; (2) Shall employ appropriately qualified individuals as care coordinators, and care coordinator supervisors with relevant work experience, including experience with the populations of focus, including but not limited to: (a) Youth younger than 18 years old with a serious emotional disturbance or co-occurring disorder; and (b) Young adults with a serious emotional disturbance or co-occurring disorder; (3) Shall assign care coordinators to the participant and family; (4) Shall schedule a face-to-face meeting with the participant and family within 72 hours of notification of the participant’s enrollment in Care Coordination services; (5) Shall convene the first CFT meeting within 30 calendar days of notification of enrollment to begin developing the POC; (6) Shall collect information gathered during the application process including results from the physical examination, psychosocial and psychiatric screening, assessments, evaluations, and information from the CFT, participant, and family, and the identified supports to be incorporated as a part of POC development process; (7) For 1915(i) participants: (a) Shall arrange for the participant and family to meet with peer support partners within 30 calendar days of notification of enrollment to allow the participant and family the opportunity to determine the role of peer support in the development and implementation of the POC; and (b) Shall arrange for the participant and family to meet with the intensive in-home service (IIHS) to develop the initial crisis plan within 1 week of enrollment in the 1915(i); (8) Shall assure that: (a) A participant’s initial assessment is completed within 10 calendar days after the participant has been authorized by Department and determined eligible for, and has elected to receive, care coordination services; and (b) An initial POC is completed within 15 calendar days after completion of the initial assessment; (9) Shall maintain an electronic health record for each participant which includes all of the following: (a) An initial referral and intake form with identifying information, including, but not limited to, the individual’s name and Medicaid identification number; (b) A written agreement for services signed by the participant or the participant’s legally authorized representative and by the participant’s care coordinator; (c) An assessment as specified in Regulation .07of this chapter; and (d) A POC as specified in Regulation .07D—E of this chapter; (10) Shall have formal written policies and procedures, approved by the Department, or the Department’s designee, which specifically address the provision of care coordination to participants in accordance with the requirements of this chapter; (11) Shall be available to participants and, as appropriate, their families or, if the participant is a minor, the minor’s parent or guardian, for 24 hours a day, 7 calendar days a week, in order to refer: (a) Participants to needed services and supports; and (b) In the case of a behavioral health emergency, participants to behavioral health treatment and evaluation services in order to divert the participant’s admission to a higher level of care; (12) Shall document in the participant’s care coordination records if the participant declines care coordination services or if a service is terminated because it was not working; (13) May not provide other services to participants unless the Department approves how conflict of interest standards would be safely addressed. (14) Shall be knowledgeable of the eligibility requirements and application procedures of federal, State, and local government assistance programs that are applicable to participants; (15) Shall maintain information on current resources for behavioral health, medical, social, financial assistance, vocational, educational, housing, and other support services including informal community resources; (16) Shall safeguard the confidentiality of the participant’s records in accordance with State and federal laws and regulations governing confidentiality; (17) Shall comply with the Department’s fiscal and program reporting requirements and submit reports to the Department in the manner specified by the Department; (18) Shall provide services in a manner consistent with the best interest of recipients and may not restrict an individual’s access to other services; (19) Shall assure the amount, duration, and scope of the care coordination activities are documented in a participant’s POC, which includes care coordination activities before discharge and after discharge when transitioning from an institution, to facilitate a successful transition into the community; and (20) Shall commit to coordinating with all agencies involved in the participant’s POC. #### Regulation .10 Mental Health Case Management Care Coordination Provider Staff. *COMAR 10.09.90.10* CCOs are required to maintain the following positions: A. Care coordinator supervisor who: (1) Is a mental health professional with a minimum of a Master’s degree and who is licensed and legally authorized to practice under Health Occupations Article, Annotated Code of Maryland, and who is licensed under Maryland Practice Boards in the profession of: (a) Social work; (b) Professional Counseling; (c) Psychology; (d) Nursing; or (e) Medicine; (2) Has a minimum of 1 year of experience in behavioral health working as a supervisor; (3) Has a minimum of 1 year of experience working with children and youth with mental health or co-occurring disorders; (4) Provides clinical consultation and training to care coordinators regarding mental health or co-occurring disorders; (5) Provides supervision of the POCs, and consultation to the CFT meetings, as needed; (6) Is employed or contracted at a ratio of one supervisor to no more than eight care coordinators; and (7) Meets training and certification requirements for care coordinator supervisors, as set by the Department; and B. Care coordinator who: (1) Has at least a: (a) Bachelor’s degree and has met the Department’s training requirements for care coordinators, or (b) High school diploma or equivalency and is 21 years old or older and was a participant in, or is a direct caregiver, or was a direct caregiver of an individual who received services from the public and child- and family-serving system and meets the training and certification requirements for care coordinators as set forth by the Department; (2) Is employed by the CCO to provide care coordination services to participants; and (3) Provides management of the POC and facilitation of the CFT meetings. #### Regulation .11 Covered Services. *COMAR 10.09.90.11* A. The Department shall reimburse for the care coordination services in this regulation when these services have been documented, pursuant to the requirements of this chapter, as necessary. B. Care coordination services shall be coordinated with, and may not duplicate activities provided as part of, institutional services and discharge planning activities. C. Care coordination may include contacts that are directly related to identifying the needs and supports for helping the participant to access services. D. The CCO shall engage in participant advocacy, including: (1) Empowering the participant and, if the participant is a minor, the minor’s parent or guardian to secure needed services; (2) Taking any necessary actions to secure services on the participant’s behalf; and (3) Encouraging and facilitating the participant’s decision making and choices leading to accomplishment of the participant’s goals or, if the participant is a minor, encouraging the parent or guardian to carry out these decisions. E. Comprehensive Participant Assessment and Periodic Participant Reassessment. (1) Providers shall use a child and youth assessment tool approved by the Department to perform participant assessments and reassessments. (2) Initial assessment or reassessment involves the participant’s stated needs and review of information concerning the participant’s mental health, social, familial, educational, cultural, medical, developmental, legal, vocational, and economic status to assist in the formulation of a POC. (3) The initial assessment or reassessment of the participant’s needs and progress shall be facilitated by the care coordinator and monitored by the CFT, which includes the participant, family members, and friends of the participant, as appropriate, or, if the participant is a minor, the minor’s parent or guardian, and community service providers, such as mental health providers, medical providers, social workers, and educators, as appropriate. (4) Coordination and Facilitation of the CFT. The care coordinator shall: (a) Identify a location for the CFT meetings that is suitable to the participant’s needs; (b) Convene the CFT at least every 6 months, or more frequently, as clinically necessary; and (c) For 1915(i) participants, convene as per the timeline and functions pursuant to COMAR 10.09.89. (5) After an initial assessment, each participant shall be reassessed at a minimum of every 6 months. F. Development and Periodic Revision of the POC. (1) After the initial assessment is completed, a POC shall be developed based on the information obtained through the comprehensive screening and assessment tools approved by the Department. (2) The CCO shall finalize the POC within 30 calendar days of notification of enrollment and submit it to the Department or its designee. (3) Development of and updates to the POC shall be youth- and family-directed and managed through CFT meetings. (4) The POC shall meet the requirements of Regulation .12 of this chapter. (5) The POC development process shall include: (a) The CFT meeting, which includes the participant, and if the participant is a minor, the minor’s parent or guardian, providers, family members, and other interested persons, as appropriate, for the purpose of establishing, revising, and reviewing the POC; (b) The development of the written, individualized POC based on the participant’s strengths, needs, and progress toward outcome measures; (c) Transitional care planning that involves contact with the participant or, if the participant is a minor, the minor’s parent or guardian, or the staff of a referring agency, or a service provider who is responsible to plan for continuity of care from inpatient level of care or an out-of-home placement to another type of community service; and (d) Discharge planning from care coordination, when appropriate and when the family is closer to its identified vision, when family needs have been met, and when outcome measures for care coordination have been achieved. (6) After the POC is developed, the CCO shall update the POC as often as clinically indicated based on the strengths and needs of the participant but not less than: (a) For Level I participants, every 6 months; (b) For Level II participants, every 3 months; (c) For Level III participants, every 45 calendar days; and (d) For all participants, within 7 calendar days following a crisis event. #### Regulation .12 Covered Services — Plan of Care. *COMAR 10.09.90.12* A. The POC shall contain, at minimum: (1) A description of the participant’s strengths and needs; (2) The diagnosis or diagnoses established as evidence of the participant’s eligibility for services under this chapter; (3) The goals of care coordination services to address the behavioral health, medical, social, educational, and other services needed by the participant, with expected target completion dates; (4) A crisis plan including the proposed strategies and interventions for preventing and responding to crises and the youth and family’s definitions of what constitutes a crisis; (5) Designation of the care coordinator with primary responsibility for implementation of the POC; (6) Signatures of the care coordinator and other CFT members, if appropriate; (7) Signatures of the participant and family indicating that the participant and family have: (a) Participated in the development of the POC; and (b) Had choice in the selection of services, providers, and interventions when possible, in the care coordination process of building the POC; and (8) For 1915(i) participants, specified for each recommended service, the following information as appropriate or as required by the Department: (a) Description of the service; (b) Service start date; (c) Estimated duration; (d) Frequency and units of service as measured in 15 minute increments to be delivered; (e) The specific need or goal that the service is related to; and (f) The provider name and contact information. B. If not included in the POC, an ongoing record of contacts made on the participant’s behalf, which includes all of the following, shall be included in the participant’s chart: (1) Date, start and end time, and subject of contact; (2) Individual contacted; (3) Electronic or scanned signature of care coordinator making the contact; (4) Nature, content, and unit or units of service provided; (5) Place of service; (6) Whether strategies and tasks specified in the POC have been achieved; (7) The timeline for obtaining needed services; (8) The timeline for reevaluation of the plan; (9) The need for and occurrences of coordination with child- and family-serving agencies and providers; (10) The names and contact information for the participant’s primary care provider, dentist, and other health care providers; (11) The medications that the participant is currently taking and the dosage and frequency of the medications; and (12) Monthly summary notes, which reflect progress made towards the identified needs and outcome measures. #### Regulation .13 Covered Services — Child and Family Team Meetings. *COMAR 10.09.90.13* The CCO shall: A. Coordinate and facilitate the CFT, with CFT meetings convened at least every 45 calendar days or more frequently as clinically indicated; B. Record and keep notes at every CFT meeting that include the CFT members who were present, a summary of the discussion, any changes to the POC, and action items for follow up, and share them with the CFT members, including those who were not in attendance; C. Update the POC to include change in progress, services, or other areas within 5 calendar days of the CFT meeting; and D. Ensure that the care coordinator: (1) Facilitates CFT meetings; (2) Facilitates access to the services and supports in the POC; and (3) At the first meeting: (a) Administers the appropriate assessments, as designated by the Department; (b) Works with the participant and family to develop an initial crisis plan that includes response to immediate service needs; and (c) For 1915(i) participants, provides an overview of the care coordination process. #### Regulation .14 Covered Services — Referral and Related Activities. *COMAR 10.09.90.14* A. The care coordinator shall ensure that the participant or, if the participant is a minor, the minor’s parent or guardian has applied for, has access to, and is receiving the necessary services available to meet the participant’s needs, such as mental health services, resource procurement, transportation, or crisis intervention. B. The care coordinator shall take the necessary action as defined by the Department when the services identified under Regulation .13 of this chapter have not occurred. C. The linkage process shall include: (1) Community and natural support development by contacting, with the participant’s consent, members of the participant’s support network, including CFT members, for example, family, friends, and neighbors, as appropriate, or, if the participant is a minor, the minor’s parent or guardian, to mobilize assistance for the participant; (2) Crisis intervention by referral of the participant or, if the participant is a minor, the minor’s parent or guardian, to services on an emergency basis when immediate intervention is necessary; (3) Arranging for the participant’s transportation to and from services; (4) Outreach in an attempt to locate service providers which can meet the participant’s needs, or, if the participant is a minor, the minor’s parent or guardian’s needs; (5) Reviewing the POC with the participant and the participant’s CFT, as appropriate, or, if the participant is a minor, with the minor’s parent or guardian, so as to enable and facilitate their participation in the plan’s implementation; and (6) Provision of health and wellness education, information, and linkages to high-quality health care services, preventive and health promotion resources, and chronic disease management services with an emphasis on resources available in the family’s community and peer group. #### Regulation .15 Covered Services — Monitoring and Follow-Up Activities. *COMAR 10.09.90.15* A. A CCO shall monitor, as per standards set forth by the Department, the activities and contacts that are considered necessary to ensure the POC is implemented and adequately addresses the participant’s needs, and include: (1) The participant or, if the participant is a minor, the minor’s parent or guardian; and (2) With proper consent: (a) Family members and friends, if appropriate; (b) Other individuals or agency representatives identified and approved as CFT members by the participant or, if the participant is a minor, the minor’s parent or guardian; and (c) Other service providers, if any. B. The CCO shall: (1) Follow up any service referral within 7 calendar days to determine whether the participant, or, if the participant is a minor, the minor’s parent or guardian, made contact with the service provider that the participant was referred to; and (2) Monitor service provision on an ongoing basis, to ensure that the agreed-upon services are provided, are adequate in quantity and quality, and meet the participant’s needs and stated goals, or, if the participant is a minor, the parent’s or guardian’s stated needs and goals for the participant. C. The CCO shall, in accordance with the decisions and recommendations of the CFT, revise the POC to reflect the participant’s changing needs. #### Regulation .16 Limitations. *COMAR 10.09.90.16* A. Care coordination services are facilitative in nature. B. A restriction may not be placed on a qualified recipient’s option to receive mental health case management services. C. Care coordination services do not restrict or otherwise affect: (1) Eligibility for Title XIX benefits or other available benefits or programs, except as limited by §E of this regulation; (2) The freedom of a participant or, if the participant is a minor, the minor’s parent or guardian to select from all available services for which the participant is found to be eligible; or (3) A participant’s free choice among qualified providers or, if the participant is a minor, the minor’s parent or guardian’s free choice among qualified providers. D. The CCO may not bill the Program for: (1) The direct delivery of an underlying medical, educational, social, or other service to which a participant has been referred; (2) Activities integral to the administration of foster care programs; (3) Activities not consistent with the definition of case management services under Section 6052 of the federal Deficit Reduction Act of 2005 (P.L. 109—171); (4) Activities for which third parties are liable to pay; (5) Activities delivered as part of institutional discharge planning; or (6) A 15-minute unit of service for telephonic contact, unless the provider has delivered at least 8 minutes of service. E. Reimbursement may not be made for care coordination services if the participant is receiving a comparable care coordination service under another Program authority. F. A participant’s care coordinator may not be the participant’s family member or a direct service provider for the participant. G. Units of services for all levels of care coordination shall be 15 minutes of contact, which may include face-to-face and, with the exception of §G(4) of this regulation, non-face-to-face contacts with the participant, or, if the participant is a minor, with the minor’s parent or guardian, and indirect collateral contacts on behalf of the participant with other community providers, as per the following: (1) For participants in Level I — General Coordination, allows a maximum of 12 units of service per month, with a minimum of two units of face-to-face contact; (2) For participants in Level II — Moderate Care Coordination, allows a maximum of 30 units of service per month, with a minimum of four units of face-to-face contact; (3) For participants in Level III — Intensive Care Coordination, allows a maximum of 60 units of service per month, with a minimum of six units of face-to-face contact; and (4) For Level I and Level II, four additional units of service above and beyond the monthly maximum may be billed during the first month of service to the participant and every 6 months thereafter to allow for comprehensive assessment and reassessment of the participant, which shall be performed as a face-to-face service. #### Regulation .17 Preauthorization. *COMAR 10.09.90.17* All covered services under this chapter shall be preauthorized and comply with the requirements of COMAR 10.09.70.07 and COMAR 10.09.89 for services delivered to 1915(i) participants. #### Regulation .18 Payment Procedures. *COMAR 10.09.90.18* A. The Program shall reimburse the provider according to the requirements in this chapter and COMAR 10.09.89 for services delivered to 1915(i) participants, and the fees established under COMAR 10.21.25. B. Request for Payment. (1) A provider shall submit requests for payment of mental health case management services according to procedures established by the Department. (2) A provider shall bill the Program for the appropriate fee under COMAR 10.21.25. (3) The Program may not make direct payment to recipients. C. Minutes of service and units per participant are to be totaled by day and by service. D. Billing time limitations for services covered under this chapter are the same as those set forth in COMAR 10.09.36.06. E. Payment shall be made: (1) Only to a qualified provider for covered services rendered to a participant, as specified in these regulations; and (2) According to the requirements of this chapter and COMAR 10.09.89 for 1915(i) participants, and the fees established in COMAR 10.21.25. F. Service Provision. Units of services for all levels of care coordination shall be 15 minutes of contact, which may include: (1) Face-to-face and non-face-to-face contacts with the participant or, if the participant is a minor, with the minor’s parent or guardian; and (2) Indirect collateral contacts on behalf of the participant with other community providers. #### Regulation .19 Recovery and Reimbursement. *COMAR 10.09.90.19* Recovery and reimbursement are as set forth in COMAR 10.09.36.07. #### Regulation .20 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.90.20* Cause for suspension or removal and imposition of sanctions is as set forth in COMAR 10.09.36.08. #### Regulation .21 Appeal Procedures. *COMAR 10.09.90.21* Appeal procedures are those set forth in COMAR 10.09.36.09. #### Regulation .22 Interpretive Regulation. *COMAR 10.09.90.22* State regulations are interpreted as those set forth in COMAR 10.09.36.10. ### Chapter 91 — Hospital Presumptive Eligibility **Authority:** Health-General Article, §§2-104(b), 2-105(b), and 15-103, Annotated Code of Maryland **Administrative History:** Effective date: December 22, 2014 (41:25 Md. R. 1485) #### Regulation .01 Purpose and Scope. *COMAR 10.09.91.01* This chapter establishes requirements for the determination of presumptive eligibility by qualified hospitals effective October 1, 2014. #### Regulation .02 Definitions. *COMAR 10.09.91.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual who has applied for presumptive eligibility at a participating hospital. (2) “Application” means the presumptive eligibility application. (3) “Authorized representative” has the same meaning as set forth in COMAR 10.01.04.01. (4) “Department” means the Maryland Department of Health which is the single State agency designated to administer the Maryland Medical Assistance Program pursuant to Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (5) “Determination” means a decision regarding an applicant’s presumptive eligibility. (6) “Federal poverty level” means the poverty guidelines updated periodically in the Federal Register by the U.S. Department of Health and Human Services under the authority of 42 U.S.C. §9902(2). (7) “Former foster care” means an individual who: (a) Is younger than 26 years old; (b) Is not eligible and enrolled for coverage under a mandatory Medical Assistance group other than childless adult; and (c) Was formerly in a Maryland out-of-home placement, including categorical Medical Assistance: (i) On attaining age 18 and leaving out-of-home placement; or (ii) On attaining age 19—21 during extended out-of-home placement under COMAR 07.02.11.04B. (8) “Hospital” means an institution which: (a) Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (b) Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. (9) “Income” means property or a service received by an individual in cash or in-kind, which can be applied directly, or by sale or conversion, to meet basic needs for food, shelter, and medical expenses. (10) “Incarcerated inmate in a public institution” has the meaning stated in COMAR 10.09.24.05-5B. (11) “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for eligible individuals. (12) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42, §U.S.C. 1395 et seq. (13) “Presumptive eligibility” means temporary eligibility for Medical Assistance as determined by participating hospitals in accordance with these regulations. #### Regulation .03 Requirements. *COMAR 10.09.91.03* A. A hospital eligible to make presumptive eligibility decisions shall: (1) Participate as a Maryland Medical Assistance Program provider in good standing; and (2) Sign an agreement prepared by the Department. B. The agreement required under §A of this regulation shall require that the hospital: (1) Comply with Departmental policies and procedures supplied by the Department at the time of application and training; (2) Meet accuracy and timeliness standards established by the Department; (3) Submit a list to the Department of hospital employees who will attend presumptive eligibility training developed by the Department; (4) Prohibit employees who have not attended required trainings and passed a post-training test to make presumptive eligibility decisions; and (5) Report all requested information on a form designated by the Department. C. Before assisting an applicant in filing a presumptive eligibility application, the hospital employee shall: (1) Check the Department’s eligibility verification system to make sure the individual is not actively enrolled in the Maryland Medical Assistance Program; (2) Provide information concerning the full Medical Assistance application process to the individual applying for presumptive eligibility and assist or refer the applicant to an individual who can assist the applicant in completing a full Medical Assistance application; (3) Determine that the applicant has not: (a) Had a prior presumptive eligibility period within the last 12 months for the individual other than pregnant women; or (b) Had a prior presumptive eligibility period during the current pregnancy for a pregnant woman. D. The hospital employee shall fill out the presumptive eligibility application based on information supplied by the applicant. E. The hospital employee shall make a presumptive eligibility decision and sign the presumptive eligibility application based on the following information obtained pursuant to COMAR 10.09.91.05: (1) Residency; (2) Citizenship; (3) Family size and composition; and (4) Gross family income. F. The hospital employee shall inform the individual in writing of the hospital’s presumptive eligibility decision which includes an explanation of the presumptive eligibility period. G. The hospital shall submit the presumptive eligibility application to the Department on the date of application completion to allow the individual to have temporary Medical Assistance coverage. H. The hospital shall: (1) Keep all written and signed presumptive eligibility applications on file for 6 years; and (2) Make the file available to the Department upon request. #### Regulation .04 Hospital or Hospital Staff Disqualifications. *COMAR 10.09.91.04* A. A hospital qualified to make presumptive eligibility decisions shall: (1) Make presumptive eligibility determinations in accordance with established Departmental policies and procedures; and (2) Disqualify individual hospital employees who do not follow established Departmental regulations, policies and procedures. B. Upon a finding that a qualified hospital has failed to meet the requirements of §A of this regulation, the Department shall provide the hospital with additional training or take other reasonable corrective action measures to address the noncompliance. C. If the remedial measures taken pursuant to §B of this regulation fail to provide a satisfactory resolution, the Department shall disqualify the hospital from making presumptive eligibility determinations. #### Regulation .05 Criteria. *COMAR 10.09.91.05* A. An individual, the individual’s guardian, or a representative of the individual with personal knowledge shall apply for presumptive eligibility through a participating hospital. B. An individual, the individual’s guardian, or a representative of the individual with personal knowledge who applies for presumptive eligibility shall attest to: (1) The citizenship requirements in COMAR 10.09.24.05; (2) The residency requirements in COMAR 10.09.24.05-3; (3) The individual’s pregnancy status; (4) The individual’s family size; and (5) The individual’s household’s gross monthly income. #### Regulation .06 Populations Eligible. *COMAR 10.09.91.06* Presumptive eligibility may be established for the following eligibility groups: A. Parents and other caretaker relatives whose household income is equal to or less than 133 percent of the federal poverty level; B. Pregnant women whose income is equal to or less than 250 percent of the federal poverty level; C. Adults without dependent children who are older than 19 years old and younger than 65 years old, whose household income is equal to or less than 133 percent of the federal poverty level; D. Children who are younger than 19 years old who are under 300 percent of the federal poverty level; or E. Former foster care individuals who are younger than 26 years old. #### Regulation .07 Limitations. *COMAR 10.09.91.07* An individual may not apply for presumptive eligibility in Maryland if the individual: A. Is currently enrolled in the Maryland Medical Assistance Program or Medicare; B. Is an incarcerated inmate in a public institution as defined in COMAR 10.09.24.05-5B; C. Had a prior presumptive eligibility period during the last 12 months with the exception of pregnant women; D. Does not meet the residency requirements stated in COMAR 10.09.24.05-3; or E. Does not meet the citizenship requirements stated in COMAR 10.09.24.05. #### Regulation .08 Certification Period. *COMAR 10.09.91.08* A. Presumptive eligibility begins on the day the hospital determines that the individual is presumptively eligible. B. Presumptive eligibility ends on the earlier of: (1) The day in which the individual is determined eligible for Medical Assistance; or (2) The last day of the month following the month in which the hospital determined presumptive eligibility, if: (a) An individual is found ineligible for Medical Assistance; or (b) An individual failed to apply for Medical Assistance. C. A non-pregnant individual may be determined presumptively eligible once per a 12-month period. D. A pregnant individual may be determined presumptively eligible once per pregnancy. #### Regulation .09 Presumptive Eligibility Appeal Rights. *COMAR 10.09.91.09* An individual or an organization does not have appeal rights for presumptive eligibility determinations. ### Chapter 92 — Acute Hospitals **Authority:** Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 2017 (44:7 Md. R. 354) **Administrative History:** Regulation .04B amended effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .05P, Q amended effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .05 R adopted effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .07A amended effective November 18, 2019 (46:23 Md. R. 1065) #### Regulation .01 Definitions. *COMAR 10.09.92.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care. (2) “Acute level of care” means care in which a patient is treated: (a) For a brief but severe episode of illness, for conditions that are the result of disease or trauma; and (b) During recovery from surgery. (3) “Acute rehabilitation hospital” means an institution devoted to therapy that is designed to facilitate the process of recovery from illness or injury for patients with various neurological, muscular-skeletal, orthopedic, and other medical conditions following stabilization of acute medical issues. (4) “Administrative day” means a day of medical services delivered to a participant who no longer requires an acute level of care. (5) “Administrative services organization (ASO)” means an organization with which the Department contracts to assist in the management and operation of the Maryland Public Behavioral Health System. (6) “Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight. (7) “Ancillary services” means diagnostic and therapeutic services, including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board. (8) “Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided in an acute hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives during an inpatient hospitalization. (9) “Date of service” means: (a) For inpatient hospitalizations, the date of admission into an acute hospital up to, but not including, the date of discharge; (b) For outpatient services, the date services are rendered in the outpatient department of the hospital; (c) For emergency services, the date or dates the services are rendered in the emergency department of an acute hospital; or (d) For observation services, the date or dates the services are rendered in an acute hospital. (10) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (11) “Designee” means any entity designated to act on behalf of the Department. (12) “Diagnosis-related group” means a participant classification system adopted by the U.S. Department of Health and Human Services, in which each hospital discharge case is assigned a category based on the primary diagnosis, secondary diagnoses (if any), procedures performed, age, sex, and discharge status of the participant. (13) “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. (14) “Emergency department” means the area in a hospital that is designed, staffed, and equipped to provide prompt treatment to individuals requiring immediate medical care for acute illness, trauma, and other medical conditions. (15) “Emergency services” means any health care service provided to evaluate and treat any medical condition where immediate, unscheduled medical care is required. (16) “Emergent condition” means a disease, illness, or injury characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson, who possesses an average knowledge of health and medicine, to result in: (a) Placing the participant’s health or, with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy; (b) Serious impairment of bodily functions; or (c) Serious dysfunction of any bodily organ or part. (17) “Freestanding medical facility” means a facility: (a) In which medical and health services are provided; (b) That is physically separate from a hospital or hospital grounds; and (c) That is an administrative part of a hospital or related institution. (18) “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (19) “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent individuals. (20) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, family, or provider. (21) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (22) “Nonqualified alien” means a foreign-born resident who: (a) Is not a naturalized U.S. citizen; and (b) Is eligible for federal Medical Assistance coverage of only emergency medical services, as specified under COMAR 10.09.24.05-2A. (23) “Observation services” means the medically necessary services used to assess the participant’s outpatient condition to determine the need for possible admission to an inpatient acute care setting. (24) “Organ” means a part of an organism that is typically self-contained and has a specific vital function, such as a heart or liver. (25) “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. (26) “Outpatient services” means nonemergency services provided to the participant on the hospital campus that do not require hospital admission. (27) “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. (28) “Patient” means an individual awaiting or undergoing health care or treatment. (29) “Preauthorization” means the approval required from the Department or its designee before a service can be rendered by the provider and reimbursed. (30) “Preoperative day” means an inpatient day in an acute hospital before: (a) Surgery for a participant who is being admitted for surgery; or (b) A surgical procedure when the participant was admitted for a nonsurgical procedure but the need for surgery arose during that stay. (31) “Program” means the Maryland Medical Assistance Program. (32) “Prospective payment system” means a predetermined amount of reimbursement per day for inpatient hospital services. (33) “Provider” means an acute hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number. (34) “Retrospective review” means the process of determining medical necessity of an inpatient admission after the participant has been discharged from the hospital. (35) “Specialty behavioral health” means services as defined in COMAR 10.09.70.02D and F. #### Regulation .02 License Requirements. *COMAR 10.09.92.02* A. In order to participate in the Program, a provider shall: (1) Be licensed as a hospital by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (2) Obtain other licenses, as set forth in COMAR 10.07.01. B. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of: (a) Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and (b) COMAR 10.10.01; or (2) If located out-of-State, comply with: (a) All applicable standards established by the state or locality in which the service is provided; and (b) The requirements of COMAR 10.09.09.02. #### Regulation .03 Conditions for Participation. *COMAR 10.09.92.03* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. To participate in the Program as an acute hospital services provider, the provider shall: (1) Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the Department of Health and Human Services; (2) Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services; (3) Accept payment by the Program as payment in full for the covered service; (4) Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; (5) Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes: (a) Date of service; (b) The participant’s chief medical complaint or reason for visit; (c) A description of the services provided, including: (i) Progress notes; (ii) Imaging studies; (iii) Laboratory results; (iv) Medication administration records; and (v) Discharge summary; and (d) A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title; and (6) If the hospital provider is the only hospital within the county, participate with each participating HealthChoice Managed Care Organization in the county. C. If an out-of-State or District of Columbia hospital, the hospital shall: (1) Unless a waiver has been granted by the Secretary of Health and Human Services, have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XVII of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act; and (2) Comply with applicable regulations of this chapter and COMAR 10.09.36. #### Regulation .04 Covered Services. *COMAR 10.09.92.04* A. The Program covers the services listed in §B of this regulation according to the conditions and requirements indicated. B. The Program covers the following hospital services: (1) Medically necessary emergency services as defined in COMAR 10.09.36.01, including triage, related ancillary services, and when necessary, observation stays of a participant who presents to a hospital emergency department; (2) Medically necessary services performed in an outpatient department of a hospital; (3) Medically necessary services performed at a freestanding medical facility; (4) Medically necessary inpatient hospital services meeting the following criteria: (a) Inpatient days, including preoperative days, determined to be medically necessary by the Department or its designee; (b) Admissions from an emergency department resulting in a medically necessary inpatient stay; and (c) Elective admissions that the Department or its designee determines to be medically necessary; (5) Inpatient stays determined to be medically necessary due to an emergent condition by the Department or its designee for a nonqualified alien; (6) Administrative days, which may include select ancillary services, determined to be necessary by the Department or its designee; and (7) Medically necessary services performed in an acute rehabilitation hospital when the participant meets the following criteria at the time of admission: (a) Requires active and ongoing therapeutic intervention of multiple therapy disciplines, one of which shall be physical or occupational therapy; (b) Requires and can reasonably be expected to actively participate in, and benefit from, the therapy, which generally consists of: (i) At least 3 hours of therapy a day, at least 5 days a week; or (ii) In well-documented cases, at least 15 hours of intensive rehabilitation therapy within a 7 day consecutive period; (c) Is sufficiently stable to be able to actively participate in the therapy program; and (d) Requires supervision by a licensed physician, who has specialized training and experience in inpatient rehabilitation, which includes: (i) Conducting face-to-face visits with the patient at least 3 days a week to assess the patient both medically and functionally; and (ii) Modifying the course of treatment as needed to maximize the participant's capacity to benefit from the rehabilitation process. C. The coverage of ancillary services during administrative days as described under §B(6) of this regulation applies to special pediatric hospitals under COMAR 10.09.94. #### Regulation .05 Limitations. *COMAR 10.09.92.05* The Program does not cover: A. Hospital services, procedures, drugs, or hospital admissions that are investigational or experimental; B. Hospital services denied by Medicare as not medically necessary; C. Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant's inability to take appropriate oral medications is documented in the participant's medical record; D. Elective inpatient admissions without preauthorization; E. Elective inpatient admissions from the emergency department for dialysis services that are the result of problems occurring with placement in a freestanding dialysis facility; F. Outpatient visits for one or more of the following: (1) Prescription drug or food supplement pick up; (2) Collection of specimens for laboratory procedures; (3) Recording of an electrocardiogram; (4) Ascertaining the participant's weight; and (5) Administration of vaccines; G. Interpretation of laboratory tests or panels; H. Autopsies; I. Weight control medications; J. Care provided to a well newborn beyond the: (1) Length of the mother's stay for a normal obstetrical or uncomplicated caesarean section delivery; or (2) First 4 days of the newborn's life when the mother remains in the hospital due to other circumstances; K. Telephones, televisions, or personal comfort items or services; L. Duplicate care or services; M. Elective admissions to hospitals outside of Maryland, except the District of Columbia, unless the Department or its designee determines that comparable services are not available in Maryland; N. Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner; O. Inpatient days provided in excess of the days approved by the Department or its designee; P. Hospital laboratory tests which are coverable under COMAR 10.09.09, unless the specimen is obtained in the hospital for a participant receiving inpatient, outpatient, emergency department, or observation services; Q. Hospital services provided outside of the United States; and R. Ancillary services that are part of an observation stay beyond the initial 24 hours. #### Regulation .06 Utilization Review. *COMAR 10.09.92.06* A. Elective Inpatient Preauthorization Reviews. (1) The hospital shall only request preauthorization for inpatient stays when such services: (a) Cannot be provided on an outpatient basis; or (b) Can only be provided in a facility that is licensed as an acute hospital. (2) The hospital shall obtain preauthorization for elective inpatient admissions from the Department or its designee, before the participant is admitted, by providing the following information including, but not limited to: (a) Participant’s medical history and physical; and (b) Sufficient clinical information or documentation that supports the medical necessity of the acute inpatient admission. B. Concurrent Reviews. (1) As long as the participant remains hospitalized, the Department or its designee shall perform concurrent reviews based on the participant’s diagnosis and medical condition. (2) For emergency inpatient admissions that exceed more than 24 hours, the concurrent review process shall be initiated by the hospital within the first 48 hours of the admission, or by the next business day. (3) For elective inpatient admissions, the hospital shall initiate the concurrent review process before the termination of days previously certified by the Department or its designee. (4) The hospital shall forward sufficient clinical documentation to the Department or its designee that supports the need for continuing acute care. Documentation submitted shall include, but is not limited to: (a) Current medical health status; (b) Treatment received to date; and (c) A proposed treatment plan for the continued stay. C. Retrospective Reviews. (1) The hospital shall request that the Department or its designee perform a retrospective review of an inpatient admission after the participant is discharged, to determine the medical necessity of the admission and stay. (2) The hospital shall provide the following to the Department or its designee when requesting a retrospective review following discharge from an acute hospital. Documentation submitted shall include, but is not limited to: (a) The participant’s complete medical record; (b) The principal, secondary, and tertiary diagnoses; and (c) All surgical procedure codes. D. Reviews for Nonqualified Aliens. The Department or its designee reviews the admission and discharge summary of an emergency inpatient admission for a nonqualified alien to determine whether the inpatient hospital stay meets the emergent condition criteria as defined in COMAR 10.09.24.05-2A. E. Reviews for Behavioral Health. The hospital shall contact the behavioral health ASO to request an authorization for all inpatient admissions that are described in COMAR 10.09.70.02D and F. #### Regulation .07 Payment Procedures. *COMAR 10.09.92.07* A. Reimbursement Principles for Acute Hospitals Located in Maryland. (1) The Department will make no direct reimbursement to any State-operated hospital. The Department will claim federal fund recoveries from the U.S. Department of Health and Human Services for services to participants in State-operated hospitals. (2) Except for administrative days, acute hospitals shall be reimbursed at the rate set for the Program by the HSCRC pursuant to COMAR 10.37.10 or allowed under COMAR 10.37.03. (3) If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse providers: (a) According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or (b) On the basis of charges if less than reasonable cost. (4) The Department may not reimburse for the services of a hospital’s salaried or contractual clinical staff as a separate line item. Charges for these services should be included in the room and board rate or the appropriate ancillary service only, when HSCRC has included these salaries in the hospital’s costs. (5) The Program shall reimburse room and board charges from the day of admission up to, but not including, the date of discharge from the hospital. (6) The provider shall submit a request for payment according to procedures established by the Department. (7) The Program reserves the right to return to the provider any invoice that is not properly completed. (8) Payments on Medicare claims are authorized if: (a) The provider accepts Medicare assignment; (b) Medicare makes a direct payment to the provider; (c) Medicare determined that services are medically necessary; (d) The services are covered by the Program; and (e) Initial billing is made directly to Medicare according to Medicare guidelines. (9) The Department shall make a supplemental payment on Medicare claims as follows: (a) Deductible and co-insurance shall be paid in accordance with the limits of this regulation; and (b) Hospitals shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case the deductible and co-insurance shall be paid in full. (10) The provider shall not bill the Department or participant for: (a) Completion of forms and reports; (b) Broken or missed appointments; (c) Services rendered by mail, telephone, or otherwise not in person, with the exception of telehealth services in accordance with COMAR 10.09.49; and (d) Providing a copy of a participant’s medical record, when requested by another licensed provider on behalf of the participant. (11) Billing time limitations are set forth in COMAR 10.09.36.06. (12) Freestanding medical facilities are reimbursed by the Department at the rate set for the freestanding facility by HSCRC. B. Reimbursement Principles for Out-of-State Hospitals. (1) For hospitals outside of Maryland, excluding the District of Columbia, claims reflecting dates of service on or after October 1, 2009, shall be reimbursed at a rate that is 100 percent of the amount reimbursable by the host state’s Title XIX agency or the amount of the hospital’s actual charges in total, whichever is less. (2) Out-of-State providers are responsible for reimbursing the Department or its designee for overpayments, in accordance with COMAR 10.09.36.07. C. Reimbursement Principles for Administrative Days. (1) The hospital shall be paid for administrative days that are requested at the time of retrospective review and that are authorized by the Department or its designee after review of the: (a) Clinical documentation; (b) Discharge plan indicating that the hospital was seeking placement for the participant on the administrative days requested; and (c) Documentation that was submitted to the Department on the authorized form that shows placement activity occurred on each day claimed as an administrative day. (2) To be paid for administrative days, for participants who are not ventilator dependent, the reimbursement amount shall be an estimated Statewide average of the Program nursing home payment rate as determined by the Department. (3) A hospital is not eligible for administrative day reimbursement if the days have already been billed as acute days. D. Reimbursement Principles for Freestanding Acute Rehabilitation Hospitals. For freestanding acute rehabilitation hospitals not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse these hospitals using a prospective payment system. #### Regulation .08 District of Columbia Hospital Reimbursement. *COMAR 10.09.92.08* A. Inpatient Services Rate Calculation. (1) A hospital in the District of Columbia shall: (a) Bill its usual and customary charges; and (b) Be reimbursed for covered services the lesser of its percentage of charges as calculated in §A(2) of this regulation or its charges. (2) The percentage of charges in §A(1) of this regulation is the product of the following: (a) The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; (b) The lesser of 100 percent or the cost-to-charge projection percentage which is: (i) The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and (ii) Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §A(2)(a) of this regulation, to the midpoint of the prospective payment period; (c) The percentage of the hospital’s costs which are efficiently and economically incurred as adjusted to reflect labor market differences between District of Columbia hospitals and Maryland hospitals; and (d) The uncompensated care factor which is equal to: (i) For pediatric hospitals with average lengths of stay less than 18 days, one plus two and a half times the quotient of the hospital’s uncompensated care divided by gross revenue; or (ii) For all other hospitals, one plus the quotient of the hospital’s uncompensated care divided by gross revenue. (3) Effective for dates of service starting July 1, 2012, and forward, the rate calculated for FY 2012 in accordance with §A(2) of this regulation shall be increased by 9 percent. (4) A hospital in the District of Columbia shall be reimbursed for administrative days in accordance with Regulation .07C of this chapter. (5) Efficiently and economically incurred District of Columbia hospitals’ costs are those costs which are: (a) Less than or equal to the adjusted costs for the same all-participant, refined-diagnosis-related groups in Maryland hospitals; (b) For hospitals with average lengths of stay of 18 days or more: (i) Less than or equal to the adjusted cost for the same diagnosis-related groups in Maryland hospitals; and (ii) Categorized into the following two age groups: younger than 18 years old, and 18 years old or older; (c) Exclusive of: (i) Maryland case charges greater than $500,000; and (ii) District of Columbia hospital case charges greater than $500,000 times the ratio of the average charge of the District of Columbia hospital case divided by the average charge of the Maryland hospital case; and (d) Derived from hospital costs as specified in this subsection. (6) Maryland hospital costs are the hospitals’ charges reduced by the hospital-specific ratio of operating costs to gross charges as determined by the Program or designee. (7) There may not be a year-end cost settlement. B. Outpatient Services. (1) A hospital located in the District of Columbia shall: (a) Bill its usual and customary charges; and (b) Be reimbursed for covered services the lesser of its percentage of charges as calculated in §B(2) of this regulation or its charges. (2) The percentage of charges in §B(1) of this regulation is the product of: (a) The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; and (b) The lesser of 100 percent or the cost-to-charge projection percentage which is: (i) The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and (ii) Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §B(2)(a) of this regulation, to the midpoint of the prospective payment period. (3) Effective for dates of service starting July 1, 2012, and forward, the rates calculated for FY 2012 in accordance with §B(2) of this regulation shall be increased by 9 percent. (4) The analysis shall be performed by the Program or its designee. (5) There may not be a year-end cost settlement. (6) Outpatient reimbursement rates are implemented in conjunction with, and are applicable to, the same dates of service as inpatient rates. C. Submitting Cost Reports. (1) The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. (2) When reports are not received within 5 months and an extension has not been granted: (a) For hospitals reimbursed in accordance with this regulation, the Program shall reduce the inpatient percentage of payment for that hospital by 5 percentage points, starting the calendar month after the calendar month in which the report is due, which will remain in effect until the report has been submitted, and there will be no refund; or (b) For hospitals reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: (i) Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and (ii) Refund withholdings at cost settlement. (3) If a provider discontinues participation in the Program, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. (4) The Program shall grant an extension for submission of cost reports: (a) Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or (b) Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. (5) In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §C(2) of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .12 of this chapter. (6) When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. (7) For purposes of §C(1)—(6) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. (8) When a report is received after imposing a reduction as specified in §C(2)(a) of this regulation, the rate of reimbursement calculated using the latest cost report information shall be implemented starting with the 1st day of the 4th full calendar month after the month in which the report was received by the Program. #### Regulation .09 Submitting Cost Reports for Freestanding Acute Rehabilitation Hospitals. *COMAR 10.09.92.09* A. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. B. For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: (1) Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and (2) Refund withholdings at cost settlement. C. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. D. The Program shall grant an extension for submission of cost reports: (1) Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or (2) Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. E. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .12 of this chapter. F. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. G. For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. #### Regulation .10 Cost Settlement for Freestanding Acute Rehabilitation Hospitals. *COMAR 10.09.92.10* A. Retrospective Cost Reimbursement for Freestanding Acute Rehabilitation Hospitals. (1) An acute rehabilitation hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed according to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413, or on the basis of charges if less than reasonable cost. (2) In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, or groups of costs, or costs of specific groups of participants. (3) When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments, thus resulting in a reduction of allowable costs. (4) Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found in 42 CFR §413, adjusted for Medicaid allowable costs. Allowable costs specific to the Program shall be limited to a base year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year. (5) Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year shall be: (a) For an existing provider, the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved; or (b) For a new provider, the 12-month period immediately before the provider was initially subject to target rate increases. (6) Initial Interim Rates. In order to establish an initial interim rate, the provider shall submit to the Department or its designee, before the beginning of the first billing period, the following: (a) A detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate; (b) A current, projected, and prior year’s charge rate schedule; (c) Finalized prior year’s Medicare cost reports and the most current submission; (d) A detailed revenue schedule; and (e) Audited financial statements. (7) The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment on a charge basis exceed the allowable cost for these services. (8) Initial Interim Rates for Newly Established Services or Providers. (a) The provider shall submit to the Department or its designee, a detailed cost build-up, consistent with Medicare principles and cost finding that supports the requested rate that follows. (b) The Department will compare the rate with a compatible facility and determine a reasonable rate that does not exceed the projected charges. (9) Revision of Interim Rates. (a) The provider may request an interim rate revision if the actual and projected costs exceed the interim rate by 10 percent. (b) The provider shall furnish the Department or its designee with appropriate documentation showing the reason for the increase and other necessary comparisons. (c) The Department will lower the provider’s interim rate to closely approximate the final allowable reasonable cost based on the results of the prior year’s review. (d) The provider may request no more than one interim rate revision during the provider’s fiscal year. (10) Cost Settlement. The provider shall submit to the Department or its designee: (a) A Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement; (b) A copy of its Maryland Medical Assistance log; (c) Cost reports that are sufficient in detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers; and (d) A finalized Medicare cost report for the cost reporting year. (11) Final Program costs shall be Maryland Medical Assistance specific. (12) Tentative cost settlements may not be performed on a routine basis. However, the Program reserves the right to calculate tentative settlements in limited cases, when appropriate, as determined by the Department. (13) The Department will base final settlement on the results of the finalized Medicare cost reports. B. The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under §A(10)—(13) of this regulation. C. Within 60 days after the provider receives the notification described in §B of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal. D. The provider may request review of the settlement under §A(10)—(13) of this regulation by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee. E. The Appeal Board shall be composed of the following: (1) A representative of the hospital industry who is: (a) Knowledgeable in Medicare and Medicaid reimbursement principles; and (b) Appointed by the Secretary of the Department; (2) An individual who: (a) Is employed by the State; (b) Is knowledgeable in Medicare and Medicaid reimbursement principles; (c) Did not participate in the verification of costs; and (d) Is appointed by the Secretary of the Department; and (3) A third member selected by the first two members of the Appeal Board. F. When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member. G. If the provider elects not to appeal to the Appeal Board: (1) The provider shall pay the amount due within 60 days after the notification described in §B of this regulation; (2) The provider may request a longer payment schedule within 60 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule; and (3) The Department shall establish a longer payment schedule if, in the Department’s judgment based on sufficient documentation submitted by the provider, failure to grant a longer payment schedule would: (a) Result in financial hardship to the provider; or (b) Have an adverse effect on the quality of participant care furnished by the facility. H. If the provider elects to appeal to the Appeal Board, the following provisions apply: (1) Within 30 days after a provider’s filing of an appeal of the Department or its designee’s determination that the provider owes money to the Program, the Department or its designee shall: (a) Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and (b) Notify the provider of that amount; (2) In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed; (3) Subject to the provisions of §H(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and (4) If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G(3) of this regulation. I. Appeal Board Findings. (1) After the Department receives the findings of the Appeal Board, the Department shall: (a) Determine the amount that is due either to the Program or to the provider; and (b) Notify the provider of that amount. (2) The portion of the amount in controversy that is paid is subject to an award of interest that is: (a) Calculated from the date the appeal was filed through the date of payment; and (b) Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. (3) Interest paid to a provider under §I(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs. (4) If the provider accepted the determination made under §I(1) of this regulation, within 60 days after the provider receives the notification under §I(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any. (5) Subject to §I(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any. (6) If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G(3) of this regulation. J. After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§G—I of this regulation, and in addition to the sanctions provided in Regulation .12 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. K. The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the decision of the Appeal Board as the final decision for judicial review under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland. L. If the provider or the Department appeals the final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §I(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination. M. The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding. #### Regulation .11 Recovery and Reimbursement. *COMAR 10.09.92.11* A. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. B. If refund of a payment as specified in §A of this regulation is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. #### Regulation .12 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.92.12* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .13 Appeal Procedures. *COMAR 10.09.92.13* A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .14 Interpretive Regulation. *COMAR 10.09.92.14* General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10. ### Chapter 93 — Chronic Hospitals **Authority:** Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 2017 (44:7 Md. R. 354) **Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .05A amended effective May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .07A amended effective May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .08A, B amended effective May 20, 2019 (46:10 Md. R. 487) #### Regulation .01 Definitions. *COMAR 10.09.93.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care. (2) “Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care that the provider is licensed to deliver. (3) “Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where individuals stay at least overnight. (4) “Ancillary services” means diagnostic and therapeutic services including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board. (5) “Appropriate facility” means: (a) A facility located within a 25-mile radius of the participant’s residence; or (b) If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance. (6) “Brain injury” means an injury or insult to the brain that occurs after birth and is not related to congenital or degenerative disease, which results in cognitive, physical, behavioral, or emotional disability that is documented in the medical record. (7) “Brain injury community integration program” means a program located on the campus of a licensed chronic hospital and approved by the Department to treat individuals with primary diagnoses of brain injury resulting in functional limitations and disability, who need services designed to transition to home or a community-based program of services and supports. (8) Chronic Hospital. (a) “Chronic hospital” means an institution licensed by the Maryland Department of Health in accordance with COMAR 10.07.01.03B, which provides services to patients with complex medical needs who do not require hospitalization in an acute hospital, but whose treatment needs exceed the capabilities of a nursing facility. (b) “Chronic hospital” does not mean a: (i) Long-term care hospital, as defined at 42 CFR §412.23(e); or (ii) Long-term care facility, as defined at 42 CFR §483.5(a). (9) “Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided by a chronic hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives, performed during an inpatient hospitalization. (10) “Date of service” means: (a) For inpatient hospitalizations, the date of admission into a chronic hospital up to, but not including, the date of discharge; or (b) For outpatient services, the date services are rendered in the outpatient department of the hospital. (11) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (12) “Designee” means any entity designated to act on behalf of the Department. (13) “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. (14) “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (15) “Interdisciplinary team” means a physician-led multidisciplinary clinical team consisting of, at a minimum: (a) The participant or an individual of the participant’s choice; (b) A physician; (c) A registered nurse; (d) A social worker; (e) The participant’s case manager; and (f) Any other clinical professional indicated by an individual’s specific needs, including but not limited to: (i) A psychologist; (ii) A behavioral analyst; (iii) A dietitian or nutritionist; and (iv) Licensed therapists in other disciplines. (16) “Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (17) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, family, or provider. (18) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (19) “Neuro-behavioral” means the discipline within medical rehabilitation that focuses on behavioral impairments seen in association with brain injury resulting from trauma, hypoxia, or ischemia. (20) “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. (21) “Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission. (22) “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. (23) “Program” means the Maryland Medical Assistance Program. (24) “Provider” means a chronic hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number. #### Regulation .02 License Requirements. *COMAR 10.09.93.02* A. In order to participate in the Program, a provider shall: (1) Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital; and (2) Obtain any other licenses required by COMAR 10.07.01. B. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of: (a) Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and (b) COMAR 10.10.01; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02. C. The provider shall obtain accreditation by the Commission on Accreditation of Rehabilitation Facilities if it provides neuro-behavioral rehabilitation or brain injury services. #### Regulation .03 Conditions for Participation — General. *COMAR 10.09.93.03* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. To participate in the Program as a chronic hospital services provider, the provider shall: (1) Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the U.S. Department of Health and Human Services; (2) 24 hours per day, 7 days per week, meet the following staffing requirements: (a) On-call or on-site physician services; (b) On-site registered nurses; (c) On-site respiratory therapist services; and (d) On-site advanced cardiac life support services; (3) Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services; (4) Accept payment by the Program as payment in full for the covered service; (5) Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; and (6) Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes: (a) Date of service; (b) The participant’s chief medical complaint or reason for admission; (c) A description of the services provided, including: (i) Progress notes; (ii) Imaging studies; (iii) Laboratory results; (iv) Medication administration records; and (v) Discharge summary; and (d) A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title. #### Regulation .04 Specific Conditions for Provider Participation — Brain Injury Community Integration Program. *COMAR 10.09.93.04* A. To participate in the Program as a provider operating a brain injury community integration program, the provider shall be: (1) Accredited by the Commission on Accreditation of Rehabilitation Facilities; and (2) Approved by the Department to provide the Program. B. Staff Requirements. In addition to the requirements in Regulation .03 of this chapter, a brain injury community integration program shall meet staffing requirements, as approved by the Program, necessary to provide the neuro-behavioral management programming set forth in Regulation .05D of this chapter. C. At least annually, in a form specified by the Program, a provider operating a brain injury community integration program shall report on the individuals admitted to and participating in the program, including: (1) Length of stay; (2) Discharge setting; and (3) Any other data specified by the Program. #### Regulation .05 Covered Services. *COMAR 10.09.93.05* A. Chronic hospitals shall provide the following services: (1) Complex respiratory care services; (2) Complex wound care services; (3) Services for participants with multiple co-morbidities, including but not limited to services necessary to care for: (a) Ventilator-assisted individuals who have been ventilator dependent for less than 6 months and who need further medical stabilization or are candidates for weaning from ventilator assistance; (b) Tracheostomy participants who require suctioning more frequently than every 2 hours or are candidates for decannulation; (c) More than two extensive stage IV decubiti which require daily intensive treatment that is not available in a nursing facility; or (d) Extensive post-operative or post-traumatic care with multiple drains or extensive dressing change or therapies beyond the capabilities of a nursing facility; (4) For participants admitted for medically necessary rehabilitation services, physical therapy, occupational therapy, or speech therapy, directed by an interdisciplinary team; and (5) Ancillary services. B. Treatment Plan. (1) Within 24 hours of a participant’s admission, a physician shall perform a documented face-to-face evaluation of the participant and begin developing an individualized treatment plan designed to meet the participant’s assessed needs. (2) By the 7th day of a participant’s admission, an interdisciplinary team shall establish a written, individualized treatment plan for the participant, which shall include, at a minimum: (a) Diagnoses; (b) Treatment goals; (c) Frequency of interventions for each type of service ordered; (d) Duration of treatment of each type of service ordered; and (e) Prognosis. (3) The physician-led interdisciplinary team shall update the individualized treatment plan weekly until discharge. C. The Program covers outpatient hospital services provided by a chronic hospital when the services are: (1) Medically necessary; and (2) Provided to individuals who are eligible for Medical Assistance and who are not current inpatients at the chronic hospital, except when payment for certain outpatient services provided to a participant on the date of inpatient admission or within 3 calendar days before the date of an inpatient admission are bundled, in accordance with 42 CFR §412.2(c)(5). D. The program covers the following brain injury community integration program services: (1) Neuro-behavioral management programming, which includes, but is not limited to: (a) Assessment of maladaptive behaviors using valid and reliable behavioral measurement tools; (b) Pharmacologic intervention provided to manage maladaptive behaviors related to brain injury; (c) Neuro-behavioral programming created, implemented, overseen, and revised as needed; (d) Incorporation of neuro-behavioral programming into therapy and care for participants in the community integration program; and (e) Referral to a neuro-psychiatrist, as needed, if a neuro-psychiatrist is not a member of the facility staff; (2) Cognitive skills adaptation and compensation programming, including: (a) Specific programming dedicated to cognitive skills adaptation and compensation; and (b) Incorporation of cognitive compensatory strategies into community integration program participant’s interdisciplinary team treatment; (3) Community re-entry programming, including specific programming dedicated to social or pragmatic skills, leisure skills, and life skills; and (4) According to the participant’s needs: (a) The services of a psychiatrist or psychiatric nurse; (b) Services and supports related to substance use disorders and other addictions; (c) Speech therapy, which includes but is not limited to: (i) Cognitive skills; (ii) Communication skills; (iii) Swallowing ability; and (iv) Linguistic programming that assists the patient to connect the meaning of words to their context; (d) Occupational therapy, which includes but is not limited to: (i) Instrumental activities of daily living; and (ii) Community re-entry activities; (e) Physical therapy, which includes but is not limited to: (i) Ambulation; and (ii) Motor planning and coordination; (f) Dietary services, which includes but is not limited to nutritional needs assessment and monitoring; and (g) Case management, which includes but is not limited to: (i) Treatment planning; and (ii) Discharge planning. E. The Program covers administrative days approved by the Department or its designee according to the conditions set forth in Regulation .08C of this chapter. #### Regulation .06 Limitations. *COMAR 10.09.93.06* The Program does not cover: A. Services for individuals who are not eligible for Medicaid; B. Services for individuals who are not medically eligible for chronic hospital services; C. Services identified by the Department or its designee as not medically necessary; D. Hospital services, procedures, drugs, or hospital admissions that are investigational or experimental; E. Duplicated care or services; F. Interpretation of laboratory tests or panels; G. Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner involved in the participant’s care; or H. Telephones, televisions, or personal comfort items or services. #### Regulation .07 Medical Eligibility. *COMAR 10.09.93.07* A. General Requirements. (1) An admission to a chronic hospital is medically necessary for a participant whose: (a) Medical condition is not stabilized subsequent to a course of treatment at an acute hospital, or whose deteriorating medical condition resulted in a readmission to an acute hospital from a nursing facility or community setting; and (b) Service and care needs require active and continuing medical treatment at an intensity and frequency not provided in a nursing facility, as defined in COMAR 10.09.10.01B, such as: (i) 24-hour availability of a physician, physician assistant, or nurse practitioner, and associated nursing staff; and (ii) Active and continuing medical treatment by a physician at least three times per week as documented in the medical record, physician orders, and physician progress notes. (2) An admission to a chronic hospital is medically necessary for a participant who: (a) Requires rehabilitation services of a lesser intensity or frequency than the acute inpatient rehabilitation services provided in a special rehabilitation hospital; and (b) May have comorbidities or a level of medical complexity that preclude admission to a special rehabilitation hospital. (3) A participant who may not be able to fully participate in a chronic hospital rehabilitation program may be admitted for a brief trial period of inpatient care after review by the Department or its designee and approval by the Program. If no progress on rehabilitative goals occurs, the participant shall be discharged to a lower level of care. B. Medical Criteria for Brain Injury Community Integration Programs. In order to be preauthorized by the Program for services in a brain injury community integration program, a participant: (1) Shall have a primary diagnosis of brain injury; (2) Shall be at low risk of potential medical instability; (3) May not require acute inpatient physical rehabilitation services; (4) Shall require an intensive neuro-behavioral or neuro-cognitive rehabilitation program at a chronic level of care as described in §A of this regulation in order to: (a) Address pervasive and persisting maladaptive behaviors, or behavioral health risk factors, that preclude a safe discharge to the community or to a less restrictive setting; and (b) Relearn basic living and adaptive skills; (5) Shall have potential for achievement of specific functional outcomes with the potential of improving functional ability so that discharge to a less restrictive setting is a reasonable goal; (6) Shall need rehabilitative programming, which may include: (a) Recreation therapy; (b) Speech language pathology; (c) Occupational therapy; (d) Physical therapy; and (e) Neuro-psychology; (7) Shall require at least two contacts daily within the rehabilitative programming that address the neuro-behavioral or neuro-cognitive needs of the participant; (8) Shall require active and continued clinical treatment by a physician who is experienced in neuro-rehabilitation and in psychopharmacology for a minimum of three contacts per week; (9) Shall require a structured and integrated environment of care that provides on-going behavioral programming designed to reduce maladaptive behaviors that are reinforced by clinical support and administrative staff; (10) Shall make progress toward the achievement of specified functional outcomes; and (11) Shall have the ability to participate in the required number of therapy sessions. #### Regulation .08 Utilization Review. *COMAR 10.09.93.08* A. Admission and Prior Approval. (1) For participants and individuals who have applied for Medical Assistance, the provider shall request a determination from the Department or its designee at the time of admission, or at the time of application for Medical Assistance, that the individual meets the medical eligibility criteria set forth in Regulation .07A of this chapter. (2) For a participant to be preauthorized for services in a brain injury community integration program, a provider that meets the requirements of Regulation .04 of this chapter shall request a determination from the Department or its designee that the participant meets the criteria set forth in Regulation .07B of this chapter. (3) If the provider obtains the determination set forth in §A(1) or (2) of this regulation after admission, the eligibility determination shall be effective on the date that the determination was requested. B. Concurrent Review. (1) On a monthly basis, the provider shall notify the Department or its designee of all persons who have: (a) Received an initial determination of medical eligibility for chronic hospital services; (b) Been determined to continue to meet medical eligibility criteria for chronic hospital services; (c) Been discharged; or (d) Been determined to no longer be medically eligible. (2) Concurrent review shall be conducted every 14 days as long as the participant remains hospitalized to ensure the medical necessity of the participant’s inpatient stay. (3) The Department or its designee may conduct on-site reviews. C. Administrative Days. (1) To be paid for administrative days, the provider shall document, in a form designated by the Department, information which satisfies the conditions listed below: (a) The participant who was initially eligible has been determined to no longer require chronic hospital services, and the provider has: (i) Received a determination from the Department or its designee that the participant requires the level of service provided by a nursing facility but an appropriate facility is not available; (ii) Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; and (iii) Submitted documentation to the Department or its designee that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; or (b) The participant is no longer medically eligible to receive chronic hospital services but cannot be moved, and the following conditions are met: (i) The medical reason the participant cannot be moved is documented by the attending physician in the participant’s medical record; (ii) The attending physician reevaluates the medical cause of the participant’s inability to be moved at least once every 7 days; and (iii) The provider documents the active treatments used to resolve the medical cause of the participant’s inability to be moved; (2) To receive reimbursement for administrative days, the provider shall document that it has met the conditions of §C(1) of this regulation, at least every 14 days. (3) Documentation shall be submitted to the Department or its designee no later than 3 business days following the end of the 14-day period. #### Regulation .09 Payment Procedures. *COMAR 10.09.93.09* A. Reimbursement of Maryland Chronic Hospitals. (1) In-State chronic hospitals shall be reimbursed according to: (a) Rates approved by the HSCRC pursuant to COMAR 10.37.03; or (b) The administrative day rate as follows: (i) For a participant who is not ventilator-dependent, payment for approved administrative days shall be the estimated Statewide average Medicaid nursing facility payment rate as determined by the Department; and (ii) For a participant who is ventilator-dependent, payment for approved administrative days shall be the estimated average Medicaid nursing facility payment rate for ventilator-dependent residents as determined by the Department. (2) State-operated chronic hospitals shall be reimbursed according to Regulation .10 of this chapter. The Department shall make no direct reimbursement to any State-operated chronic hospital. B. Reimbursement of Out-of-State Hospitals. (1) The Department shall reimburse an out-of-State hospital that provides a level of service equivalent to that provided at a chronic hospital only if: (a) The proposed admission is first reviewed by the Department or its designee and the out-of-State placement is determined medically necessary according to Regulation .07A of this chapter; (b) The hospital possesses the same certifications and accreditations as the Program requires for a comparable level of services and specific program in a Maryland chronic hospital; and (c) The hospital meets one of the following conditions: (i) The hospital proposes to provide a service or specific treatment that the participant cannot obtain in a Maryland chronic hospital; or (ii) The hospital is located geographically closer to the established residence of the participant than a Maryland chronic hospital. (2) The Department shall reimburse an out-of-State hospital at the lesser of: (a) The average rate established by the HSCRC for an equivalent cost center for a Maryland chronic hospital; or (b) The rate charged by the out-of-State hospital pursuant to 42 CFR Part 412, Subpart O. #### Regulation .10 Cost Reporting — State-Operated Chronic Hospitals. *COMAR 10.09.93.10* A. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. B. For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: (1) Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and (2) Refund withholdings at cost settlement. C. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. D. The Program shall grant an extension for submission of cost reports: (1) Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or (2) Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. E. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .14 of this chapter. F. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. G. For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. #### Regulation .11 Cost Settlement — State-operated Chronic Hospitals. *COMAR 10.09.93.11* A. Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found at 42 CFR §413, adjusted for Program allowable costs. Allowable costs specific to the Program shall be limited to a base year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year. B. Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year for an existing provider shall be the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved. C. The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment exceed the allowable cost for these services. D. Revision of Interim Rates. The provider may request an interim rate revision should the actual and projected cost exceed the interim rate by 10 percent. The provider shall furnish the Department or its designee with appropriate schedules showing the reason for the increase and any other information supporting the request. The Department will lower the provider’s interim rate to closely approximate the final allowable reasonable cost based on the results of the prior year’s review. The provider may request not more than two interim rate revisions during the accounting year. E. Cost Settlement. The provider shall submit to the Department or its designee a Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement. The provider shall also submit a copy of its Maryland Medical Assistance log. The submitted cost report shall be in sufficient detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers. Tentative cost settlements may not be performed on a routine basis. However, the Program reserves the right to calculate tentative settlements in limited cases, when appropriate, as determined by the Department. The provider shall furnish the Department or its designee with a finalized Medicare cost report for the cost reporting year. The Department will base final settlement on the results of the finalized Medicare cost reports. #### Regulation .12 Cost Settlement for State-operated Chronic Hospitals — Payments and Appeals. *COMAR 10.09.93.12* A. The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under Regulation .11 of this chapter. B. Within 60 days after the provider receives the notification described in §A of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal. C. The provider may request review of the settlement under Regulation .11 of this chapter by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee. D. The Appeal Board shall be composed of the following: (1) A representative of the hospital industry who is: (a) Knowledgeable in Medicare and Medicaid reimbursement principles; and (b) Appointed by the Secretary of the Department; (2) A person who: (a) Is employed by the State; (b) Is knowledgeable in Medicare and Medicaid reimbursement principles; (c) Did not participate in the verification of costs; and (d) Is appointed by the Secretary of the Department; and (3) A third member selected by the first two members of the Appeal Board. E. When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member. F. If the provider elects not to appeal to the Appeal Board: (1) The provider shall pay the amount due within 60 days after the notification described in §A of this regulation; (2) If the provider requests a longer payment schedule within 60 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule; and (3) The Department shall establish a longer payment schedule if, in the Department’s judgment based on sufficient documentation submitted by the provider, failure to grant a longer payment schedule would: (a) Result in financial hardship to the provider; or (b) Have an adverse effect on the quality of participant care furnished by the facility. G. If the provider elects to appeal to the Appeal Board, the following provisions apply: (1) Within 30 days after a provider appeals a determination by the Department or its designee that the provider owes money to the Program, the Department or its designee shall: (a) Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and (b) Notify the provider of that amount; (2) In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed; (3) Subject to the provisions of §G(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and (4) If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation. H. Appeal Board Findings. (1) After the Department receives the findings of the Appeal Board, the Department shall: (a) Determine the amount that is due either to the Program or to the provider; and (b) Notify the provider of that amount. (2) The portion of the amount in controversy that is paid is subject to an award of interest that is: (a) Calculated from the date the appeal was filed through the date of payment; and (b) Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. (3) Interest paid to a provider under §H(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs. (4) If the provider accepted the determination made under §H(1) of this regulation, within 60 days after the provider receives the notification under §H(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any. (5) Subject to §H(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any. (6) If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §F(3) of this regulation. I. After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§F—H of this regulation, and in addition to the sanctions provided in Regulation .14 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. J. The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the decision of the Appeal Board as the final decision for judicial review under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland. K. If the provider or the Department appeals the final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §H(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination. L. The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding. #### Regulation .13 Recovery and Reimbursement. *COMAR 10.09.93.13* A. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. B. If refund of a payment as specified in §A of this regulation, is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. #### Regulation .14 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.93.14* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .15 Appeal Procedures. *COMAR 10.09.93.15* A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .16 Interpretive Regulation. *COMAR 10.09.93.16* General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10. ### Chapter 94 — Special Pediatric Hospitals **Authority:** Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 2017 (44:7 Md. R. 354) #### Regulation .01 Definitions. *COMAR 10.09.94.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acute hospital” means an institution that provides active, short-term medical diagnosis, treatment, and care. (2) “Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care that the provider is licensed to deliver. (3) “Admission” means the formal acceptance by a hospital of a participant who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight. (4) “Ancillary services” means diagnostic and therapeutic services including but not limited to radiology, laboratory tests, pharmacy, and physical therapy services, provided exclusive of room and board. (5) “Appropriate facility” means: (a) A facility located within a 25-mile radius of the participant’s residence; or (b) If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance. (6) “Concurrent review” means a periodic reauthorization of continued medical eligibility for the level of services provided by a special pediatric hospital, which allows for close monitoring of the participant’s progress, treatment goals, and objectives, performed during an inpatient hospitalization. (7) “Date of service” means: (a) For inpatient hospitalizations, the date of admission into a special pediatric hospital up to, but not including, the date of discharge; or (b) For outpatient services, the date services are rendered in the outpatient department of the hospital. (8) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (9) “Designee” means any entity designated to act on behalf of the Department. (10) “Diagnosis-related group” means a participant classification system adopted by the U.S. Department of Health and Human Services, in which each hospital discharge case is assigned a category based on the primary diagnosis, secondary diagnoses, if any, procedures performed, and age, sex, and discharge status of the participant. (11) “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. (12) “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (13) “Level of care” means an assessment that an individual needs the level of services provided in a special psychiatric hospital. (14) “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (15) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, family, or provider. (16) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (17) “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. (18) “Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission. (19) “Participant” means an individual who is enrolled with the Department to receive Medical Assistance services. (20) “Plan of treatment” means a written plan developed by a participant’s consulting physician and other appropriate clinicians, which is provided to the Department on request and includes: (a) Diagnosis; (b) Treatment goals; (c) Specific procedures planned for the participant, including surgeries; (d) Duration of treatment of each type of service ordered; (e) Expected length of stay; and (f) Any other appropriate information, including caregiver education and discharge plan. (21) “Program” means the Maryland Medical Assistance Program. (22) “Prospective payment system” means a predetermined amount of reimbursement per day for inpatient hospital services. (23) “Provider” means a special pediatric hospital which, through agreement with the Department, has been identified as a Program provider by the issuance of a provider number. (24) Special Pediatric Hospital. (a) “Special pediatric hospital” means a facility licensed by the Office of Health Care Quality as a special hospital that provides nonacute medical, rehabilitation, therapy, and palliative services to children and adolescents younger than 22 years old. (b) “Special pediatric hospital” includes an out-of-State or District of Columbia hospital identified by the Program as: (i) A facility that provides nonacute medical, rehabilitation, therapy, and palliative services to children and adolescents younger than 22 years old; and (ii) A facility that provides nonacute medical, rehabilitation, and therapy services to individuals ages 2 through 22 with co-occurring medical and behavioral conditions. #### Regulation .02 License Requirements. *COMAR 10.09.94.02* A. In order to participate in the Program, a provider shall: (1) Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital; and (2) Obtain other licenses, as set forth in COMAR 10.07.01. B. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of: (a) Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and (b) COMAR 10.10.01; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02. #### Regulation .03 Conditions for Participation. *COMAR 10.09.94.03* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36. B. To participate in the Program as a special pediatric hospital services provider, the provider shall: (1) Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the U.S. Department of Health and Human Services; (2) Directly provide, or make available through contractual arrangements or transfer agreements, medically necessary covered services; (3) Accept payment by the Program as payment in full for the covered services; (4) Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; and (5) Maintain documentation of each contact with the participant as part of the complete medical record, which, at a minimum, includes: (a) Date of service; (b) The participant’s chief medical complaint or reason for admission or outpatient visit; (c) A description of the services provided, including: (i) Progress notes; (ii) Imaging studies; (iii) Laboratory results; (iv) Medication administration records; and (v) Discharge summary; and (d) A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title. C. If an out-of-State or District of Columbia hospital, the hospital shall: (1) Have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XIX of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act unless a waiver has been granted by the Secretary of Health and Human Services; and (2) Allow HealthChoice managed care organizations to pay no more and no less than the reimbursement rates established in Regulation .07 of this chapter unless the parties mutually agree to an alternative arrangement in a contract either on or after July 1, 2011. #### Regulation .04 Covered Services. *COMAR 10.09.94.04* A. The Program covers the following inpatient services at special pediatric hospitals: (1) A hospital admission determined to be medically necessary for a participant who is stable enough for transfer to a post-acute setting and requires medical or rehabilitative services that: (a) Cannot be provided at a lower level of care; and (b) Meets the medical eligibility criteria under Regulation .06 of this chapter; (2) Administrative days for the length of time certified by the Department or its designee; (3) Inpatient admissions for intensive occupational therapy, physical therapy, or speech therapy on a regimen which is less than 3 hours per day, 5 days per week, when these services are provided in a unit that is accredited by the Commission on Accreditation of Rehabilitation Facilities to provide rehabilitation services; and (4) Ancillary services. B. The Program covers the following outpatient hospital services: (1) Medically necessary services for the provision of diagnostic, curative, palliative, or rehabilitative treatment; and (2) For a participant younger than 21 years old, physical therapy, occupational therapy, speech therapy, and audiology services if: (a) The therapy provider develops a written plan of treatment in collaboration with the participant’s primary care physician and the participant or the parent or guardian of the participant; (b) The service is provided according to the plan of treatment; and (c) The services provider sends an update of the plan of treatment to the participant’s primary care physician every 90 days. #### Regulation .05 Limitations. *COMAR 10.09.94.05* The Program does not cover: A. Investigational or experimental hospital services, procedures, or drugs; B. Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant’s inability to take appropriate oral medications is documented in the participant’s medical record; C. Outpatient visits intended to accomplish one or more of the following: (1) Prescription drug or food supplement pick-up; (2) Collection of specimens for laboratory procedures; (3) Recording of an electrocardiogram; or (4) Ascertaining the participant’s weight; D. Interpretation of laboratory tests or panels; E. Autopsies; F. Immunizations required for travel outside the continental United States; G. Leaves of absence beyond the period of the census check of the same day; H. Day care; I. Psychological evaluations and treatments except when: (1) Ordered by a physician, and the medical necessity is documented in the participant’s medical record; or (2) Performed as mental health service, as part of the plan of treatment; J. Duplicated care or services; K. Elective admissions to hospitals outside of Maryland and the District of Columbia unless the Department or its designee determines that comparable services are not available in Maryland, except under certain conditions where child participants are in foster care, or are for other reasons placed outside the State and are covered under certain criteria, as determined by the Department or its designee; L. Inpatient and outpatient diagnostic services not specifically ordered by the attending physician or other responsible practitioner; M. Inpatient days or services provided in excess of the days approved by the Department or its designee; N. Hospital laboratory tests which are coverable under COMAR 10.09.09.04, if the specimen is not obtained in the hospital; O. Hospital services provided outside of the United States; P. The completion of forms and reports; Q. Broken or missed appointments; R. Professional services rendered by mail or telephone; or S. Telephones, televisions, or personal comfort items or services. #### Regulation .06 Utilization Review. *COMAR 10.09.94.06* A. The Department or its designee shall conduct utilization review to determine that special pediatric hospital admissions and outpatient services are authorized only when medically necessary. B. Review Procedure. (1) For all admissions, the special pediatric hospital shall provide: (a) The elements of a participant’s medical record specified by the Department or its designee for preadmission review, and request to certify the participant’s admission; and (b) Sufficient clinical information or documentation to the Department or its designee that supports the need for admission to a special pediatric hospital including, but not limited to: (i) Current medical health status; (ii) Treatment received to date; (iii) Proposed treatment plan for requested admission; and (iv) Expected length of stay. (2) Admission for inpatient services may be authorized only when these services cannot be provided: (a) On an outpatient basis; or (b) In a facility that is licensed to provide a more appropriate level of care to the participant. (3) Concurrent review shall be conducted as long as the participant remains hospitalized, based on the participant’s diagnosis and condition, to ensure the medical necessity of the participant’s inpatient stay, at the following intervals: (a) After an initially authorized 14-day stay, or at the end of the expected length of stay identified at admission, whichever comes first; and (b) Every 14 days following the initial concurrent review, in a form and including clinical documentation as specified by the Department or its designee. (4) The Department or its designee may conduct on-site reviews after an initially authorized period of 30 days, and every 30 days thereafter until discharge. (5) An elective inpatient hospital admission requires preadmission authorization by the Department or its designee. C. Administrative Days. (1) To be paid for administrative days, the provider shall document, in a form designated by the Department, information which satisfies the conditions listed below: (a) The participant has been determined to no longer require special pediatric hospital services, and the provider has: (i) Received a determination from the Department or its designee that the participant requires the level of service provided in a lower-acuity facility, but an appropriate facility is not available; (ii) Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; and (iii) Submitted documentation to the Department or its designee that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; or (b) The participant is no longer medically eligible to receive special pediatric hospital services but cannot be moved, and the following conditions are met: (i) The medical reason the participant cannot be moved is documented by the attending physician in the participant’s medical record; (ii) The attending physician reevaluates the medical cause of the participant’s inability to be moved at least once every 7 days; and (iii) The provider documents the active treatments used to resolve the medical cause of the participant’s inability to be moved; (2) To receive reimbursement for administrative days, the provider shall document that it has met the conditions of §C(1) of this regulation, at least every 14 days. (3) Documentation shall be submitted to the Department or its designee no later than 3 business days following the end of the 14-day period. #### Regulation .07 Payment Procedures. *COMAR 10.09.94.07* A. HSCRC Reimbursement Principles. (1) Except for hospitals reimbursed under the provisions of §B of this regulation and except for administrative days, hospitals located in Maryland that participate in the Program shall charge and be reimbursed according to rates approved by the HSCRC pursuant to COMAR 10.37.03. (2) If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse a provider: (a) According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or (b) On the basis of charges if less than reasonable cost. (3) The Department may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item. B. Annual Market Basket Reimbursement Principles. (1) Except as specified in §B(2)—(5) of this regulation, a special pediatric hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed according to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413, or on the basis of charges if less than reasonable cost. In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, or groups of costs, or costs of specific groups of participants. When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments, thus resulting in a reduction of allowable costs. (2) For days of service on or after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse these hospitals using a prospective payment system consisting of per diem rates based on service categories audited and adjusted in the provider’s fiscal year 2004 cost report. The base per diem rates shall be: (a) Annually adjusted by the factor indicated in the Centers for Medicare and Medicaid Services Annual Market Basket Update Factor for the Long Term Care Hospital Prospective Payment System; and (b) Determined by allocating Medicaid inpatient costs into service categories as follows: (i) Rehabilitation categories — $1,486.58; (ii) Feeding categories — $2,213.98; (iii) Severe behavior categories — $2,544.66; and (iv) Other categories — $1,126.69. (3) For new services established after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Program shall pay at an initial rate that is set as an interim rate at the Medicaid weighted average rate of all existing inpatient per diem rates. After the first full year, actual cost data shall be used to prospectively set the new service rate. (4) For days of service on or after July 1, 2006, in special pediatric hospitals with pediatric rehabilitation beds in Maryland not approved by the Program for reimbursement according to HSCRC rates, the Department shall reimburse hospital based outpatient services on a prospective basis that shall be adjusted annually by the difference between the: (a) Medicaid weighted average charge increase; and (b) Centers for Medicare and Medicaid Services Outpatient Prospective Payment System Market Basket Update Factor. (5) For outpatient services in §B(4) of this regulation, the revenue shall be maintained at the fiscal year 2011 level beginning July 1, 2011. C. Out-of-State Hospitals Reimbursement Principles. (1) An out-of-State hospital, except a hospital located in the District of Columbia, shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency. The hospital shall be reimbursed for administrative days in accordance with Regulation .09E of this chapter. (2) For outpatient services, an out-of-State hospital, except a hospital located in the District of Columbia, shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency. #### Regulation .08 District of Columbia Hospital Reimbursement. *COMAR 10.09.94.08* A. Inpatient Services Base Rate Calculation. (1) A hospital in the District of Columbia shall: (a) Bill its usual and customary charges; and (b) Be reimbursed for covered services the lesser of its percentage of charges as calculated in §A(2) of this regulation or its charges. (2) The percentage of charges in §A(1) of this regulation is the product of the following: (a) The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; (b) The lesser of 100 percent or the cost-to-charge projection percentage which is: (i) The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and (ii) Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §A(2)(a) of this regulation, to the midpoint of the prospective payment period; (c) The percentage of the hospital’s costs which are efficiently and economically incurred as determined in accordance with §A(6) of this regulation; and (d) The uncompensated care factor, which is equal to one plus the quotient of the hospital’s uncompensated care divided by gross revenue. (3) Effective for dates of service starting July 1, 2012, and forward, the rate calculated for FY 2012 in accordance with §A(2) of this regulation shall be increased by 9 percent. (4) A hospital in the District of Columbia shall be reimbursed for administrative days in accordance with Regulation .08C of this chapter. (5) Efficiently and economically incurred District of Columbia hospitals’ costs are costs which are: (a) Less than or equal to the adjusted costs for the same all participant refined-diagnosis related groups in Maryland hospitals; (b) For hospitals with average lengths of stay of 18 days or more: (i) Less than or equal to the adjusted cost for the same diagnosis-related groups in Maryland hospitals; and (ii) Categorized into the following two age groups: younger than 18 years old, and 18 years old or older; (c) Exclusive of: (i) Maryland case charges greater than $500,000; and (ii) District of Columbia hospital case charges greater than $500,000 times the ratio of the average charge of the District of Columbia hospital case divided by the average charge of the Maryland hospital case; and (d) Derived from hospital costs as specified in this subsection. (6) Maryland hospital costs are the hospitals’ charges reduced by the hospital specific ratio of operating costs to gross charges as determined by the Program or designee. (7) There may not be a year-end cost settlement. (8) For hospitals located in the District of Columbia that are not acute children’s hospitals, the reimbursement amount described in §A(1) of this regulation will be reduced by 2 percent. B. Outpatient Services. (1) A hospital located in the District of Columbia shall: (a) Bill its usual and customary charges; and (b) Be reimbursed for covered services the lesser of its percentage of charges as calculated in §B(2) of this regulation or its charges. (2) The percentage of charges in §B(1) of this regulation is the product of: (a) The cost-to-charges percentage using only those costs of the hospital reported in the hospital’s most recent cost report as determined by the Program or its designee; and (b) The lesser of 100 percent or the cost-to-charge projection percentage which is: (i) The hospital’s cost-to-charge ratio in its most recent cost report trended by its cost-to-charge ratio in the 2 prior years’ cost reports or, if 3 years of data are not available, the hospital’s cost-to-charge ratio in its most recent cost report divided by its cost-to-charge ratio in the prior year’s cost report; and (ii) Applied from the midpoint of the report period used to develop the cost-to-charges percentage in §B(2)(a) of this regulation, to the midpoint of the prospective payment period. (3) Effective for dates of service starting July 1, 2012, and forward, the rates calculated for FY 2012 in accordance with §B(2) of this regulation shall be increased by 9 percent. (4) The analysis shall be performed by the Program or its designee. (5) There may not be a year-end cost settlement. (6) Outpatient reimbursement rates are implemented in conjunction with, and are applicable to, the same dates of service as inpatient rates. C. Cost Reporting. (1) A special pediatric hospital provider reimbursed according to this regulation shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. (2) When reports are not received within 5 months and an extension has not been granted: (a) For hospitals reimbursed in accordance with Regulation .08 of this chapter, the Program shall reduce the inpatient percentage of payment for that hospital by 5 percentage points, starting the calendar month after the calendar month in which the report is due, which will remain in effect until the report has been submitted, and there will be no refund; or (b) For a hospital reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: (i) Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and (ii) Refund withholdings at cost settlement. (3) If a provider discontinues participation in the Program, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. (4) The Program may grant an extension for submission of cost reports: (a) Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or (b) Concurrent with any extension granted to the hospital by Medicare, but not to exceed 60 days from the due date of cost reports. (5) When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year, and the provider has not received an extension, the Department may impose, in addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §C(2) of this regulation, one or more sanctions as provided for in Regulation .11 of this chapter. (6) When a report is not submitted by the last day of the sixth month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. (7) For purposes of §C(1) — (6) of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. (8) When a report is received after imposing a reduction as specified in §C(2)(a) of this regulation, the rate of reimbursement calculated using this cost report information shall be implemented starting the 1st day of the 4th full calendar month after the month in which the report was received by the Program. #### Regulation .09 Billing and Reimbursement Principles. *COMAR 10.09.94.09* A. The Program shall pay room and board charges for the day of admission, and may not pay room and board charges for the day of discharge from the hospital. B. The provider shall submit a request for payment according to procedures designated by the Department. C. Payments of Medicare Claims. (1) Payment of Medicare claims is authorized if: (a) The provider accepts Medicare assignment; (b) Medicare makes direct payment to the provider; (c) Medicare determined that services were medically necessary; (d) The services are covered by the Program; and (e) Initial billing is made directly to Medicare according to Medicare guidelines. (2) Payment of a deductible and co-insurance related to Medicare claims shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case deductible and co-insurance shall be paid in full. D. Out-of-State Hospital Reimbursement. (1) The Program shall reimburse hospitals outside of Maryland, excluding the District of Columbia, at a rate that is 100 percent of the amount reimbursable by the host state’s Title XIX agency or the amount of the hospital’s actual charges in total, whichever is less. (2) Out-of-State providers are responsible for reimbursing the Department for overpayments, in accordance with Regulation .10 of this chapter. E. Payment for Administrative Days. (1) The provider shall document, on forms designated by the Department, information that satisfies the conditions stated in Regulation .06C of this chapter. (2) The provider shall: (a) Receive determination from the Department or its designee that the participant no longer requires the level of care that the special pediatric hospital is licensed to provide; (b) Receive determination from the Department or its designee that the participant requires services at a lower level of acuity, and a bed in an appropriate facility is not available; and (c) Notify the Department or its designee of discharge planning before the termination of the need for inpatient hospitalization at the level the facility is licensed to provide, and obtained a level of care determination from the agent. F. During the period of administrative days, the Department or its designee shall review the documentation in increments of not more than 14 days. G. For participants who are not ventilator-dependent, payment for approved administrative days shall be the lesser of: (1) An estimated Statewide average Medicaid nursing home payment rate as determined by the Department; or (2) If the hospital has a unit which is a skilled nursing facility, the allowable costs in effect under Medicare or extended services provided to participants of the unit. H. The Department will make no direct payment to the participant. I. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. J. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. K. Noncompliance with the Program’s requirements as determined by the Department or its designee shall result in nonpayment of the claim. L. Payment on claims to a hospital located in the District of Columbia shall be reduced by a quarterly claims processing fee of 6 percent. #### Regulation .10 Recovery and Reimbursement. *COMAR 10.09.94.10* A. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. B. If refund of a payment as specified in §A of this regulation is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. #### Regulation .11 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.94.11* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .12 Appeal Procedures. *COMAR 10.09.94.12* A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .13 Interpretive Regulation. *COMAR 10.09.94.13* General policies governing the interpretive regulations that are applicable to providers are set forth in COMAR 10.09.36.10. ### Chapter 95 — Special Psychiatric Hospitals **Authority:** Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 2017 (44:7 Md. R. 354) **Administrative History:** Regulation .05B amended effective September 9, 2019 (46:18 Md. R. 774); May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .07A amended effective December 31, 2018 (45:26 Md. R. 1245) #### Regulation .01 Definitions. *COMAR 10.09.95.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative day” means a day of medical services delivered to a participant who no longer requires the level of care which the provider is licensed to deliver and is awaiting placement in a nursing home or residential care facility. (2) “Admission” means the formal acceptance by a specialty psychiatric hospital of a patient who is to be provided with room, board, and medically necessary services in an area of the hospital where patients stay at least overnight. (3) “Ancillary services” means diagnostic and therapeutic services, provided exclusive of room and board, including but not limited to: (a) Radiology; (b) Laboratory tests; (c) Pharmacy services; and (d) Physical therapy services. (4) “Appropriate facility” means: (a) A facility located within a 25-mile radius of the participant’s residence; or (b) If acceptable to the participant, a more distant facility, which is licensed and certified to render the participant’s required level of care, except when the only facility or facilities that provide the level of care and specialized services required by the participant exceed that distance. (5) “Concurrent review” means a periodic reauthorization of continued eligibility for the level of services provided by a special psychiatric hospital which allows for close monitoring of the participant’s progress, treatment goals, and objectives during an inpatient hospitalization. (6) “Date of service” means: (a) For inpatient hospitalizations, the date of admission into a special psychiatric hospital up to, but not including, the date of discharge; (b) For outpatient services, the date services are rendered in the outpatient department of the special psychiatric hospital; and (c) For observation services, the date or dates the services are rendered in a special psychiatric hospital, which are ordered by a medical staff practitioner to determine the need for inpatient admission. (7) “Department” means the State Maryland Department of Health, which is the single State agency designated to administer the Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq. (8) “Designee” means any entity designated to act on behalf of the Department. (9) “Electronic signature” means a secure electronic identification of an individual who authorizes an electronic record or transaction. (10) “Emergent condition” means a disease, illness, or injury characterized by sudden onset and symptoms of sufficient severity, including severe pain, that the absence of immediate medical attention could reasonably be expected by a prudent layperson, who possesses an average knowledge of health and medicine, to result in: (a) Placing the participant’s health or, with respect to a pregnant woman, the health of the woman or unborn child in serious jeopardy; (b) Serious impairment of bodily functions; or (c) Serious dysfunction of any bodily organ or part. (11) “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (12) “Level of care” means an assessment that an individual needs the level of services provided in a special psychiatric hospital. (13) “Maryland Medical Assistance Program” means the program of comprehensive medical and other health-related care for indigent and medically indigent persons. (14) “Medicaid” means the Maryland Medical Assistance Program. (15) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the participant, family, or provider. (16) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (17) “Mental health services” means those services described in COMAR 10.09.59.06 rendered to treat the diagnoses set forth in COMAR 10.09.70.02. (18) “Nonqualified alien” means a foreign-born resident who: (a) Is not a naturalized U.S. citizen; and (b) Is eligible for federal Medical Assistance coverage of only emergency medical services, as specified under COMAR 10.09.24.05-2A. (19) “Observation services” means the medically necessary diagnostic services used to assess the participant’s outpatient condition to determine the need for possible admission to an inpatient special psychiatric care setting. (20) “Organ” means a part of an organism that is typically self-contained and has a specific vital function, such as a heart or liver. (21) “Out-of-State hospital” means any hospital outside of Maryland, except for hospitals located in the District of Columbia. (22) “Outpatient services” means services provided to the participant on the hospital campus that do not require hospital admission. (23) “Partial hospitalization” means outpatient, intensive, nonresidential psychiatric treatment, which is an alternative to inpatient acute general hospitalization, for any part of a 24-hour day for a minimum of 4 consecutive hours per day. (24) “Participant” means a person who is certified as eligible for and is receiving Medical Assistance benefits. (25) “Patient” means an individual awaiting or undergoing health care or treatment. (26) “Plan of treatment” means a written plan, developed to address the referred problem or problems, which includes: (a) Diagnosis; (b) Treatment goals; (c) Frequency of visits for each type of service ordered; (d) Duration of treatment of each type of service ordered; (e) Prognosis; and (f) Other appropriate items. (27) “Preauthorization” means the approval required from the Department or its designee before a service can be rendered by the provider and reimbursed. (28) “Program” means the Maryland Medical Assistance Program. (29) “Provider” means a special psychiatric hospital which through agreement with the Department has been identified as a Program provider by the issuance of a provider number. (30) “Retrospective review” means the process of determining medical necessity of an inpatient admission after the participant has been discharged from the hospital. (31) “Special psychiatric hospital” means an institution that: (a) Provides short-term services for psychiatric illnesses in a hospital setting with facilities, medical staff, and all necessary personnel to provide diagnosis, care, and treatment; (b) Falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (c) Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided. #### Regulation .02 License Requirements. *COMAR 10.09.95.02* A. In order to participate in the Program, a provider shall: (1) Be licensed by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a specialty psychiatric hospital; and (2) Obtain other licenses, as set forth in COMAR 10.07.01. B. A provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and: (1) If located in Maryland, comply with requirements of: (a) Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and (b) COMAR 10.10.01; or (2) If located out-of-State, comply with other applicable standards established by the state or locality in which the service is provided and with the requirements of COMAR 10.09.09.02. #### Regulation .03 Conditions for Participation. *COMAR 10.09.95.03* A. A provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03. B. To participate in the Program as a special psychiatric hospital services provider, the provider shall: (1) Meet the requirements of Title XIX of the Social Security Act for participation as a hospital, as issued by the Department of Health and Human Services; (2) Meet the following staffing requirements 24 hours per day, 7 days per week: (a) On-call or on-site physician services including psychiatric physicians; (b) On-site registered nurses; (c) On-site advanced cardiac life support services; (3) If licensed to provide inpatient psychiatric services for individuals younger than 21 years old: (a) Meet the requirements for participation as defined in 42 CFR §440.160; and (b) Provide acute psychiatric services as defined in 42 CFR Part 441, Subpart D; (4) Directly provide or make available through contractual arrangements or transfer agreements, medically necessary covered services; (5) Accept payment by the Program as payment in full for the covered service; (6) Make available to the Department or its designee the participant’s medical record for review and certification of medical necessity for admission and continuation of stay; (7) Maintain documentation of each contact with the participant as part of the medical record, which, at a minimum, includes: (a) Date of service; (b) A plan of treatment as defined in Regulation .01B of this chapter; (c) The participant’s chief medical complaint or reason for visit; (d) A description of the services provided, including: (i) Progress notes; (ii) Imaging studies; (iii) Laboratory results; (iv) Medication administration records; and (v) Discharge summary; and (e) A signature, electronic or handwritten, along with the printed or typed name of the individual providing care, with the appropriate title; (8) Submit to the Department or its designee within 5 months of the close of the hospital’s fiscal year, as required by the Department, a hospital cost report for outpatient services which are subject to cost settlement in accordance with Regulation .11 of this chapter; C. If an out-of-State or District of Columbia hospital, the special psychiatric hospital shall: (1) Unless a waiver has been granted by the Secretary of Health and Human Services, have in effect a utilization review plan applicable to all participants who receive Medical Assistance under Title XVII of the Social Security Act which meets the requirements of §1861(k) of the Social Security Act; and (2) Comply with applicable regulations of this chapter and COMAR 10.09.36. #### Regulation .04 Covered Services. *COMAR 10.09.95.04* A. The Program covers the following inpatient special psychiatric hospital services: (1) Medically necessary services for the number of days, per admission, including days certified by the Department or its designee; (2) Medically necessary mental health services authorized in accordance with COMAR 10.09.59.08 and as set forth in Regulation .05B(4) of this chapter; (3) Medically necessary services when these services are: (a) Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment; and (b) Described in the participant’s medical record in sufficient detail to support the invoices submitted for services. (4) Administrative days for the length of time certified by the Department or its designee; (5) Leaves of absence for therapeutic reasons or extenuating circumstances up to 12 hours per day, if the participant returns the same day, before the census check; and (6) Observation services. B. The Program covers partial hospitalization when the hospital has: (1) Written approval from the Office of Licensing and Certification Programs to be a provider of partial hospitalization in accordance with COMAR 10.21.02; (2) A certificate of need from the Maryland Health Resources Planning Commission, if required, to be a provider of partial hospitalization; and (3) Obtained preauthorization in accordance with COMAR 10.09.59.08. #### Regulation .05 Limitations. *COMAR 10.09.95.05* A. There are limitations placed on the coverage of some special psychiatric hospital inpatient and outpatient services. B. The Program does not cover: (1) Special psychiatric hospital services, procedures, drugs or admissions that are investigational or experimental; (2) Services identified by the Department or its designee as not medically necessary; (3) Elective inpatient admissions without preauthorization; (4) Inpatient admissions or outpatient visits solely for the administration of injections, unless medical necessity and the participant’s inability to take appropriate oral medications is documented in the participant’s medical record; (5) Inpatient mental health services for an individual between 21 and 64 in a special psychiatric hospital of more than 16 beds that primarily engages in providing mental health services for an individual who is not waiver-eligible, as defined in COMAR 10.67.01.01, except: (a) When receiving mental health services in the special psychiatric hospital immediately before the participant reached 21 years old, in which case the services may be continued until the earlier of the following: (i) The date the participant no longer requires the services; or (ii) The date the participant reaches 22 years old; (b) Effective July 1, 2019, services of up to 15 days per month, when: (i) The participant has co-occurring substance use and mental health diagnoses; and (ii) The provider is located in-State or, effective January 1, 2022, the provider is located in a contiguous state or the District of Columbia; or (c) Effective January 1, 2022, services up to 60 days, when: (i) The participant has a primary mental health diagnosis; and (ii) The provider is located in-State, a contiguous state, or the District of Columbia; (6) Outpatient visits for one or more of the following: (a) Prescription drug or food supplement pick up; (b) Collection of specimens for laboratory procedures; (c) Recording of an electrocardiogram; (d) Ascertaining the participant’s weight; and (e) Administration of vaccines; (7) Leaves of absence beyond the period of the census check of the same day; (8) Psychological evaluations and treatments except when: (a) Ordered by a physician, and the medical necessity is documented in the participant’s medical record; or (b) Performed as mental health services as part of an approved treatment plan; (9) Telephones, televisions, or personal comfort items or services; (10) Duplicated care or service as indicated by more than one charge for the same stay or more than one room accommodation for the same time, for example, a charge for an inpatient day and observation room charge; (11) Administrative days for participants pending discharge to home or nonmedical institutions; (12) Inpatient and outpatient diagnostic and laboratory services not ordered by the attending physician or other practitioner; (13) Inpatient days provided in excess of the days approved by the Department or its designee; (14) Hospital laboratory tests which are coverable under COMAR 10.09.09, unless the specimen is obtained in the hospital; (15) Admissions to special psychiatric hospitals, unless the participant is diagnosed with any one of the specialty mental health codes listed in COMAR 10.09.70.02 or unless the Department or its designee grants a special exception based on the complexity of the situation at admission; or (16) Elective admissions to hospitals outside of Maryland, except the District of Columbia, unless the Department or its designee determines that comparable services are not available in Maryland. #### Regulation .06 Utilization Review Requirements. *COMAR 10.09.95.06* A. Elective Inpatient Preauthorization Reviews. (1) The special psychiatric hospital shall only request preauthorization for inpatient stays when such services: (a) Cannot be provided on an outpatient basis; or (b) Can only be provided in a facility that is licensed as a special psychiatric hospital. (2) The special psychiatric hospital shall obtain preauthorization for elective inpatient admissions from the Department or its designee, before the participant is admitted, by providing the following information including, but not limited to: (a) Participant’s medical history and physical; and (b) Sufficient clinical information or documentation that supports the medical necessity of the inpatient admission. B. Concurrent Review Process. (1) The concurrent review process shall be initiated by the hospital. (2) If the participant remains hospitalized, additional days shall be certified by the Department or its designee before the termination of the previously certified days. (3) The special psychiatric hospital shall forward sufficient clinical information or documentation to the Department or its designee that supports the need for continuing care. Information submitted shall include: (a) Current health status; (b) Treatment received to date; (c) Proposed treatment plan for continued stay; and (d) Discharge planning. C. Retrospective Reviews. (1) The special psychiatric hospital shall request that the Department or its designee perform a retrospective review of an inpatient admission after the participant is discharged, to determine the medical necessity of the admission. (2) The special psychiatric hospital shall provide the following to the Department or its designee when requesting a retrospective review following discharge from a special psychiatric hospital. Documentation submitted shall include, but is not limited to: (a) The participant’s complete medical record; (b) The principal, secondary, and tertiary diagnoses; and (c) All relevant procedure codes. D. Reviews for Nonqualified Aliens. The Department or its designee reviews the admission and discharge summary of an emergency inpatient admission for a nonqualified alien to determine whether the inpatient special psychiatric hospital stay meets the emergent condition criteria as defined in COMAR 10.09.24.05-2A. #### Regulation .07 Payment Procedures. *COMAR 10.09.95.07* A. Reimbursement Principles. (1) The Department will make no direct reimbursement to any State-operated hospital. The Department will claim federal fund recoveries from the U.S. Department of Health and Human Services for services to participants in State-operated hospitals. (2) The Department shall compare the current rates with the projected upper payment limit for inpatient days of service on or after July 1, 2012, in freestanding private psychiatric hospitals in Maryland whose rates for commercial providers are set by the HSCRC. (3) If the rates do not exceed the projected upper payment limit calculated by the Department, the Department shall reimburse these hospitals using a rate of 94 percent of the current rates for services set by the HSCRC for each hospital’s commercial providers in the fiscal year the prospective payments are made. (4) If the rates do exceed the projected upper payment limit calculated by the Department, the per diem payments to each such hospital shall be decreased by the same proportion that the projected upper payment limit is exceeded. (5) If the Program discontinues using rates which have been approved by HSCRC, the Program shall reimburse providers: (a) According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or (b) On the basis of charges if less than reasonable cost. (6) The Department may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item. When HSCRC has included these salaries in the hospital’s costs, charges for these services shall be included in the room and board rate or the appropriate ancillary service only. (7) Payment advances other than those made in accordance with HSCRC regulations may not be made routinely. (8) Inpatient and outpatient services in District of Columbia special psychiatric and outpatient services in in-State special psychiatric hospitals are cost-settled on an annual basis according to §B of this regulation. (9) Effective October 1, 2018, an out-of-State special psychiatric hospital shall be reimbursed the lesser of its charges or the amount reimbursable by the host state’s Title XIX agency. (10) An out-of-State provider shall submit proof of host state rates on an annual basis. B. Retrospective Cost Reimbursement. (1) Except as specified in §A of this regulation, a special psychiatric hospital not approved by the Program for reimbursement according to HSCRC rates shall be reimbursed: (a) According to Medicare standards and principles for retrospective cost reimbursement described in 42 CFR §413; or (b) On the basis of charges, if less than reasonable cost. (2) In calculating retrospective cost reimbursement rates, the Department or its designee will deduct from the designated costs or group of costs those restricted contributions which are designated by the donor for paying certain provider operating costs, groups of costs, or costs of specific groups of participants. When the cost, or group or groups of costs designated, cover services rendered to all participants, including Medical Assistance participants, operating costs applicable to all participants shall be reduced by the amount of the restricted grants, gifts, or income from endowments thus resulting in a reduction of allowable costs. (3) Final settlement for services in the provider’s fiscal year shall be determined based on Medicare retrospective cost principles found at 42 CFR §413, adjusted for Medicaid allowable costs. Allowable costs specific to the Program shall be limited to a base-year cost per discharge increased by the applicable federal rate of increase times the number of Program discharges for that fiscal year. (4) Base Year. For purposes of determining limits on the increase of cost, in accordance with Medicare regulations, the base year shall be: (a) For an existing provider, the first year of entering into the Program or the first year separate rates for the unit or units of service or services are approved; and (b) For a new provider, or all of these, the 12-month period immediately before the provider was initially subjected to target rate increases. (5) Initial Interim Rates. In order to establish an initial interim rate, the provider shall submit to the Department or its designee, before the beginning of the first billing period, at least 90 days before the beginning of billing for services, the following: (a) A detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate; (b) A current, projected, and prior year’s charge rate schedule; (c) Finalized prior year’s Medicare cost reports and the most current submission; (d) A detailed revenue schedule; and (e) Audited financial statements. (6) The provider shall supply the Department or its designee the assurances necessary to establish that its customary charges to participants liable for payment on a charge basis exceed the allowable cost for these services. (7) Initial Interim Rates for Newly Established Services or Providers. (a) The provider shall submit to the Department or its designee, a detailed cost build-up, consistent with Medicare principles and cost finding, that supports the requested rate that follows Medicare principles and cost finding. (b) The Department will compare the rate with a compatible facility and determine a reasonable rate that does not exceed the projected charges. (8) Revision of Interim Rates. (a) The provider may request an interim rate revision should the actual and projected cost exceed the interim rate by 10 percent. (b) The provider shall furnish the Department or its designee with appropriate schedules showing the reason for the increase and other any other information that supports the rate increase. (c) The Department will lower the provider’s interim rate to approximate the final allowable reasonable cost based on the results of the prior year’s review. (d) The provider may request not more than two interim rate revisions during the accounting year. (9) Cost Settlement. (a) The provider shall submit to the Department or its designee: (i) A Medicaid cost report based on actual data using the cost reporting forms used by Medicare for retrospective cost reimbursement; (ii) A copy of the provider’s Program log; and (iii) A finalized Medicare cost report for the cost reporting year. (b) The final Program cost report shall be sufficiently detailed to support a separate cost finding for Maryland Medical Assistance unique cost centers. The provider shall also submit a copy of its Maryland Medical Assistance log. The submitted cost report shall be in sufficient detail to support a separate cost finding for designated Maryland Medical Assistance unique cost centers. (c) Tentative cost settlements may not be performed on a routine basis. However, the Program may, when it determines appropriate, calculate tentative settlements. The provider shall furnish the Department or its designee with a finalized Medicare cost report for the cost reporting year. (d) The Department will base final settlement on the results of the finalized Medicare cost reports. C. The Program shall reimburse room and board charges for the day of admission, but may not reimburse room and board charges for the day of discharge from the hospital. D. The provider shall submit request for payment according to procedures established by the Department. E. Payments on Medicare claims are authorized if: (1) The provider accepts Medicare assignment; (2) Medicare makes direct payment to the provider; (3) Medicare determined the services were medically necessary; (4) The services are covered by the Program; and (5) Initial billing is made directly to Medicare according to Medicare guidelines. F. Payment on Medicare claims is subject to the following provisions: (1) Deductible and co-insurance, according to the limits of §E of this regulation, shall be paid subject to the HSCRC discounts, except in the case of a participant receiving hospital services in an out-of-State facility, in which case deductible and co-insurance shall be paid in full; or (2) Services not covered by Medicare, but by the Program, if medically justified according to §E of this regulation. G. Administrative Days. (1) To be paid for administrative days, the special psychiatric hospital shall document, on forms designated by the Department, information demonstrating that the participant who was initially eligible has been determined to no longer require special psychiatric hospital services and the provider has: (a) Received a determination from the Department or its designee that the participant requires the level of service provided in a lower-acuity facility, but an appropriate facility is not available; (b) Established a plan for discharge during the period of administrative days, is actively pursuing placement at an appropriate level of care for the participant, and has documented this activity in the participant’s record; (c) Maintained documentation in the participant’s medical record that placement activity was conducted no fewer than 3 days per week during the period for which payment is requested for administrative days; and (d) Notified the local agency responsible for development of the discharge treatment and education plan of the potential placement, if the participant is at risk of a residential treatment center placement on admission; (2) If the participant requires the level of care provided by a residential treatment center and a bed in a residential treatment center is not available, in order to be paid for administrative days, the special psychiatric hospital shall document that it timely notified local coordinating councils and any other local agency, as appropriate, of the necessity to continue inpatient psychiatric service at a residential treatment center before the termination of the need for inpatient psychiatric hospitalization; (3) If the participant is at an inappropriate level of care but cannot be moved, in order to be paid for administrative days, the special psychiatric hospital shall: (a) Provide the attending physician’s declaration that, because of physical or emotional problems, the participant is unable to be moved; (b) Document in the participant’s medical record the attending physician’s reasons why the participant cannot be moved; and (c) Document the attending physician’s reevaluation of the participant’s inability to be moved in the participant’s record at least every 14 days in special psychiatric hospital. H. Payment for approved administrative days for a special psychiatric hospital seeking placement of a participant to a residential treatment center shall be the average residential treatment center rate issued pursuant to COMAR 10.09.29.13B. I. The Department may not reimburse a special psychiatric hospital for administrative days if: (1) The special psychiatric hospital bills the Program for days of care for which the hospital is licensed to provide; or (2) The Program or the Program’s designee determines the participant no longer requires the level of care for the days requested. J. The Department may not make direct payment to the participant. K. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.06. L. The Department reserves the right to return to the provider, before payment, all invoices not properly completed. M. Noncompliance with the Program’s requirements as determined by the Department or its designee shall result in nonpayment of the claim. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.09.95.08* A. General policies governing recovery and reimbursement procedures applicable to all providers are set forth in COMAR 10.09.36.07. B. If refund of a payment as specified in §A of this regulation, is not made, the Department shall reduce its current payment to the provider by the amount of the duplicate payment, overpayment, or third-party payment. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.95.09* Causes for suspension or removal and imposition of sanctions shall be as set forth in COMAR 10.09.36.08. #### Regulation .10 Appeal Procedures. *COMAR 10.09.95.10* A provider filing an appeal from an administrative decision made in connection with these regulations shall do so according to COMAR 10.09.36.09. #### Regulation .11 Submitting Cost Reports. *COMAR 10.09.95.11* A. The provider shall submit to the Department or its designee, in the form prescribed, financial and statistical data within 5 months after the end of the provider’s fiscal year unless the Department grants the provider an extension or the provider discontinues participation in the Program. B. For hospitals who do not submit reports within 5 months, for whom an extension has not been granted, and who are reimbursed according to Medicare standards and principles for retrospective cost reimbursement as described in 42 CFR §413, the Department shall: (1) Withhold from the provider a maximum of 5 percent of the current monthly interim payment starting the calendar month after the calendar month in which the report is due and any subsequent calendar months until the report has been submitted; and (2) Refund withholdings at cost settlement. C. If a provider discontinues participation, financial and statistical data shall be submitted to the Department within 45 days after the effective date of termination. D. The Program shall grant an extension for submission of cost reports: (1) Upon written request by the provider, setting forth the specific reasons for the request, if the Department determines, taking into consideration the totality of the circumstances, that the request is reasonable; or (2) Concurrent with any extension granted to the special psychiatric hospital by Medicare, but not to exceed 60 days from the due date of cost reports. E. In addition to a reduction in payment percentage or withholding a percentage of interim payment pursuant to §B of this regulation, when a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year and the provider has not received an extension, the Department may impose one or more sanctions as provided for in Regulation .09 of this chapter. F. When a report is not submitted by the last day of the 6th month after the end of the provider’s fiscal year or a report is submitted but the provider cannot furnish proper documentation to verify costs, the Department shall, if applicable, make final cost settlement for that fiscal year at a certain percentage of the last final per diem rates for which the Department has verified costs for that facility, provided that the rates established will not exceed the maximum per diem rates in effect when the facility’s costs were last settled. G. For purposes of §§A—F of this regulation, reports are considered received when the submitted reports are completed according to instructions issued by the Department or its designee. #### Regulation .12 Cost Settlement. *COMAR 10.09.95.12* A. The Department or its designee shall notify each provider participating in the Program of the results of the final settlement under Regulation .07 of this chapter. B. Within 60 days after the provider receives the notification described in §A of this regulation, the Department shall pay the amount due to the provider regardless of whether the provider files an appeal. C. The provider may request review of the settlement under Regulation .07 of this chapter by filing written notice with the Program’s Appeal Board within 30 days after receipt of the notification of the results of the settlement from the Department or its designee. D. The Appeal Board shall be composed of the following: (1) A representative of the hospital industry who is: (a) Knowledgeable in Medicare and Medicaid reimbursement principles; and (b) Appointed by the Secretary of the Department; (2) An individual who: (a) Is employed by the State; (b) Is knowledgeable in Medicare and Medicaid reimbursement principles; (c) Did not participate in the verification of costs; and (d) Is appointed by the Secretary of the Department; and (3) A third member selected by the first two members of the Appeal Board. E. When the Appeal Board reviews an appeal from a provider in which an Appeal Board member is employed or in which the member has a financial or personal interest, the Secretary of the Department shall designate an alternate for the member. F. If the provider elects not to appeal to the Appeal Board, the provider shall: (1) Pay the amount due within 60 days after the notification described in §A of this regulation; or (2) Request a longer payment schedule within 60 days after the provider receives notification of the amount due to the Program. G. After consultation with the provider, the Department may establish a longer payment schedule if it determines, based on sufficient documentation submitted by the provider, that failure to grant a longer payment schedule would: (1) Result in financial hardship to the provider; or (2) Have an adverse effect on the quality of participant care furnished by the facility. H. If the provider elects to appeal to the Appeal Board, the following provisions apply: (1) Within 30 days after the filing of an appeal by a provider that the Department or its designee determined owes money to the Program, the Department or its designee shall: (a) Recalculate the amount due to the Program based on the verification, exclusive of the amount in controversy which is subject to the appeal; and (b) Notify the provider of that amount; (2) In order to enable the Department or its designee to perform this recalculation, the provider shall indicate the specific adjustment and the specific amount being appealed; (3) Subject to the provisions of §H(4) of this regulation, payment for the amount due the Program, if any, after the recalculation, shall be made within 60 days after the provider receives notification of the recalculation; and (4) If a provider requests a longer payment schedule within 60 days after the provider receives notification of the recalculation, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G of this regulation. I. Appeal Board Findings. (1) After the Department receives the findings of the Appeal Board, the Department shall: (a) Determine the amount that is due either to the Program or to the provider; and (b) Notify the provider of that amount. (2) The portion of the amount in controversy that is paid is subject to an award of interest that is: (a) Calculated from the date the appeal was filed through the date of payment; and (b) Based on the 6-month Treasury Bill rate in effect on the date the appeal was filed. (3) Interest paid to a provider under §I(2) of this regulation is not subject to any offset or other reduction against otherwise allowable costs. (4) If the provider accepted the determination made under §I(1) of this regulation, within 60 days after the provider receives the notification under §I(1) of this regulation, the Program shall pay the amount the Department determined is due the provider, if any. (5) Subject to §I(6) of this regulation, within 60 days after the provider receives the notification, the provider shall pay the amount due the Program, if any. (6) If a provider requests a longer payment schedule within 30 days after the provider receives notification of the amount due the Program, the Department may establish, after consultation with the provider, a longer payment schedule in accordance with §G of this regulation. J. After expiration of the 60-day payment period, or longer payment schedule established by the Department as described in §§F—I of this regulation, and in addition to the sanctions provided in Regulation .09 of this chapter, the Department may recover the unpaid balance by withholding the amount due from the interim payment which would otherwise be payable to the provider. K. The Department or a provider aggrieved by a reimbursement decision of the Appeal Board may appeal the Appeal Board’s decision as the final agency decision under the Administrative Procedure Act, State Government Article, §10-222, Annotated Code of Maryland. L. If the provider or the Department appeals a final decision of the Appeal Board, the provider or the Department shall place any money due from the provider or from the Program in an interest-bearing escrow account. The money due shall include the interest, based on the rate in §I(2)(b) of this regulation, calculated from the date of the administrative appeal through the date of opening the escrow account. The money shall remain in escrow until a final decision has been rendered. Upon a final determination of the dispute, the appropriate person administering the escrow account shall distribute the money in that account, including any interest accrued, in conformity with the final determination. M. The provider may file an appeal of the results of the settlement with the Medicare Appeal Board as a substitute for the Department’s Appeal Board, and the decision rendered by the Medicare Appeal Board will be accepted by the Department as binding. #### Regulation .13 Interpretive Regulation. *COMAR 10.09.95.13* General policies governing the interpretive regulations applicable to all providers are set forth in COMAR 10.09.36.10. ### Chapter 96 — Remote Patient Monitoring **Authority:** Health-General Article, §15-103(b), Annotated Code of Maryland **Administrative History:** Effective date: January 1, 2018 (44:26 Md. R. 1215) **Administrative History:** Regulation .01C amended effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .02B amended effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .05 amended effective July 24, 2023 (50:14 Md. R. 593) **Administrative History:** Regulation .06E amended effective July 24, 2023 (50:14 Md. R. 593) #### Regulation .01 Purpose and Scope. *COMAR 10.09.96.01* A. This chapter applies to remote patient monitoring services reimbursed by the Maryland Medical Assistance Program effective January 1, 2018. B. The purpose of providing medically necessary services via remote patient monitoring is to assist participants in managing and controlling their chronic conditions in order to reduce readmissions and emergency department visits and to improve quality of care C. The target populations are high-risk Maryland Medical Assistance Program participants with a chronic disease capable of monitoring via remote patient monitoring. #### Regulation .02 Definitions. *COMAR 10.09.96.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Certified nurse midwife” means an individual who meets the licensure and conditions of participation for certified nurse midwives set forth in COMAR 10.09.01. (2) “Certified nurse practitioner” means an individual who meets the licensure and conditions of participation for certified nurse practitioners set forth in COMAR 10.09.01. (3) “Department” means the Maryland Department of Health, which is the single State agency designated to administer the (4) “Episode” means the span of treatment during which remote patient monitoring services are rendered to eligible participants. (5) “Home” means the place of residence occupied by the participant, other than a hospital, nursing facility, or other medical or psychiatric institution. (6) “Home health agency" means a public or private agency or organization that meets the licensure requirements and conditions of participation of COMAR 10.09.04. (7) “Maryland Medical Assistance Program” means the program of comprehensive medical, behavioral, and other health-related care for indigent and medically indigent individuals, jointly financed by the federal and state governments and administered by states under Title XIX of the Social Security Act, 42 U.S.C. §1396 et seq., as amended. (8) “Medically necessary” means that the service or benefit is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, family, or provider. (9) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits. (10) “Physician” means an individual who meets the licensure requirements and conditions of participation of COMAR 10.09.02. (11) “Physician assistant” means an individual who meets the licensure requirements and conditions of participation set forth in COMAR 10.09.55. (12) “Program” means the Maryland Medical Assistance Program. (13) “Provider” means an individual or an organization who: (a) Meets the requirements of Regulations .03 and .04 of this chapter; and (b) Through an appropriate agreement with the Department, has been identified as a Program provider by the issuance of a unique provider number. (14) “Remote patient monitoring” means the use of synchronous or asynchronous digital technologies that collect or monitor medical, patient-reported, and other forms of health care data for Program participants at an originating site and electronically transmit that data to a distant site provider to enable the distant site provider to assess, diagnose, consult, treat, educate, provide care management, suggest self-management, or make recommendations regarding the Program participant’s health care. #### Regulation .03 License Requirements. *COMAR 10.09.96.03* A. The provider shall: (1) Meet all license requirements as set forth in COMAR 10.09.36.02; and (2) Be licensed in the state in which the participant resides. B. A home health agency shall be: (1) Licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland; (2) Part of a hospital or related institution licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland; or (3) Legally authorized to provide home health services in the jurisdiction in which the service is provided. C. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery in the state in which the service is provided. D. A certified nurse practitioner shall: (1) Hold a current license to practice registered nursing in Maryland, and be certified as a nurse practitioner by the Nursing Board; or (2) Meet the nurse practitioner regulatory requirements of the state in which the services are provided. E. A physician assistant applying for provider status shall: (1) Be licensed to practice as a physician assistant in Maryland or in the state or jurisdiction in which the service is provided; (2) Be in compliance with requirements set forth in COMAR 10.32.03; (3) If practicing in Maryland, have a delegation agreement with a supervising physician that outlines the physician assistant’s duties within the medical practice or facility which has been filed with and approved by the Board of Physicians; and (4) If practicing in Maryland, have a delegation agreement with a supervising physician that documents the specialized training, education, and experience of the physician assistant for performing advanced duties. #### Regulation .04 Provider Conditions for Participation. *COMAR 10.09.96.04* A. To provide remote patient monitoring, the provider shall: (1) Be enrolled with an active status as a Maryland Medical Assistance Program provider on the date the service is rendered; (2) Be a: (a) Physician; (b) Physician assistant; (c) Certified nurse practitioner; or (d) Home health agency when remote patient monitoring services are prescribed by a physician; and (3) Meet the requirements for participation in the Medical Assistance Program as set forth in COMAR 10.09.36.03. B. Medical Record Documentation. A remote patient monitoring provider shall: (1) Maintain documentation using either electronic or paper medical records; (2) Retain remote patient monitoring records according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland; (3) Submit the preauthorization on a form developed by the Department; and (4) Include the participant’s consent to participate in remote patient monitoring. C. Remote patient monitoring is not a substitute for delivery of care. Provider shall see patients in person periodically for follow-up care. #### Regulation .05 Participant Eligibility for Services. *COMAR 10.09.96.05* A participant is eligible to receive remote patient monitoring services if: A. The participant is enrolled in the Maryland Medical Assistance Program on the date the service is rendered; B. The participant consents to remote patient monitoring services and has the capability to utilize the monitoring tools and take actions to improve self-management of the chronic disease; C. The participant has the internet connections necessary to host the equipment in the home; D. The participant is at risk for avoidable hospital utilization due to a poorly controlled chronic disease capable of being monitored via remote patient monitoring; and E. The provision of remote patient monitoring may reduce the risk of preventable hospital utilization and promote improvement in control of the chronic condition #### Regulation .06 Covered Services. *COMAR 10.09.96.06* A. Remote patient monitoring services include: (1) Installation; (2) Education for the participant in the use of the equipment; and (3) Daily monitoring of vital signs and other medical statistics. B. The remote patient monitoring provider shall establish an intervention process to address abnormal data measurements in an effort to prevent avoidable hospital utilization. C. Physician, nurse practitioner, and physician assistant providers who establish remote patient monitoring programs shall be responsible for: (1) Establishing criteria for reporting abnormal measurements; (2) Informing the participant of abnormal results; and (3) Monitoring results and improvements in patient’s ability to self-manage chronic conditions. D. Medical interventions by a physician, nurse practitioner, or physician assistant based on abnormal results shall be reimbursed according to COMAR 10.09.02.07. E. A home health agency shall: (1) Have an order by a physician, physician assistant, certified nurse midwife, or certified nurse practitioner who has examined the patient and with whom the patient has an established, documented and ongoing relationship; (2) Report abnormal measurements to the participant and to the ordering provider; and (3) Send the ordering provider a weekly summary of monitoring results, including improvement in patient’s ability to self-manage chronic conditions. #### Regulation .07 Limitations. *COMAR 10.09.96.07* A. Remote patient monitoring services are only covered for participants who meet the eligibility criteria specified in Regulation .05 of this chapter. B. The Program does not cover: (1) Remote patient monitoring equipment; (2) Upgrades to remote patient monitoring equipment; (3) The internet connections necessary to transmit the results of remote patient monitoring services to the provider’s offices; or (4) More than: (a) 2 months of remote patient monitoring services per episode; and (b) Two episodes per year per participant. C. Home health agencies may only be reimbursed for remote patient monitoring when the service is ordered by a physician. #### Regulation .08 Preauthorization Requirements. *COMAR 10.09.96.08* The Department may preauthorize services when the provider submits to the Department adequate documentation demonstrating the: A. Participant’s condition meets the criteria listed in Regulation .05 of this chapter; and B. Participant has not already been preauthorized for two episodes during the past rolling calendar year. #### Regulation .09 Payment Methodology. *COMAR 10.09.96.09* A. After providing the services outlined in Regulation .06 of this chapter, the remote patient monitoring provider shall submit the request for payment using the format designated by the Department. B. Home health agencies shall: (1) Bill on a UB04; and (2) Be paid a monthly rate. C. Physicians, nurse practitioners, and physician assistants who provide remote patient monitoring shall: (1) Bill using a CMS 1500 or an 837P; and (2) Be paid a monthly rate. D. Professionals following up on abnormal results from remote patient monitoring shall be paid the lesser of: (1) Provider’s customary charge unless the service is free to individuals not covered by Medicaid; or (2) The Department’s professional fee schedule as found in COMAR 10.09.02.07. #### Regulation .10 Recovery and Reimbursement. *COMAR 10.09.96.10* Recovery and reimbursement shall be in accordance with COMAR 10.09.36.07. #### Regulation .11 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.09.96.11* Cause for suspension or removal and imposition of sanctions shall be in accordance with COMAR 10.09.36.08. #### Regulation .12 Appeal Procedures. *COMAR 10.09.96.12* Providers filing appeals from administrative decisions made in connection with these regulations shall do so in accordance with COMAR 10.09.36.09. #### Regulation .13 Interpretive Regulation. *COMAR 10.09.96.13* Except when the language of a specific regulation indicates an intent by the Department to provide reimbursement for covered services to Program recipients without regard to the availability of federal financial participation, State regulations shall be interpreted in conformity with applicable federal statutes and regulations. ## Subtitle 10 — Laboratories ### Chapter 01 — General **Authority:** Courts and Judicial Proceedings Article, §10-1001; Health-General Article, §§17-201, 17-202, 17-205, 17-214, and 17-501; Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1969 **Administrative History:** Chapter revised effective March 2, 1977 (4:5 Md. R. 372) **Administrative History:** Chapter revised effective February 10, 1986 (13:3 Md. R. 271) **Administrative History:** Regulation .03N amended effective December 28, 1987 (14:26 Md. R. 2747) **Administrative History:** Regulation .06 amended effective December 28, 1987 (14:26 Md. R. 2747) **Administrative History:** Chapter revised effective October 30, 1989 (16:21 Md. R. 2261) **Administrative History:** Chapter revised effective October 29, 1990 (17:21 Md. R. 2529) **Administrative History:** Regulation .03 amended as an emergency provision effective April 1, 1994 (21:8 Md. R. 665); adopted permanently effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulations .05, .10—.12, .15, and .18 amended and new Regulation .20 adopted as an emergency provision effective May 1, 1992 (19:10 Md. R. 926) Regulation .05A amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .10B amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .12 amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .14 repealed and new Regulation .14 adopted as an emergency provision effective April 1, 1994 (21:8 Md. R. 665); adopted permanently effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulation .15 repealed and new Regulation .15 adopted effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .18C amended effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .20 adopted effective October 1, 1992 (19:15 Md. R. 1390) **Administrative History:** Chapter, Medical Laboratories in Maryland, repealed and new chapter General, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .02 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 23, 2002 (29:25 Md. R. 1982); June 1, 2009 (36:11 Md. R. 787); January 13, 2011 (38:1 Md. R. 11); April 16, 2012 (39:7 Md. R. 492); April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .04B amended effective June 1, 2009 (36:11 Md. R. Chapter, Medical Laboratories in Maryland, repealed and new chapter General, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 23, 2002 (29:25 Md. R. 1982); June 1, 2009 (36:11 Md. R. 787); January 13, 2011 (38:1 Md. R. 11); April 16, 2012 (39:7 Md. R. 492); April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04B amended effective June 1, 2009 (36:11 Md. R. 787) #### Regulation .01 Purpose. *COMAR 10.10.01.01* The people of Maryland are entitled to the highest level of competency, reliability, and accuracy that reasonably may be expected from a medical laboratory or crime laboratory. It is the intent of this subtitle to protect the public and individual health by requiring a medical laboratory or crime laboratory to employ qualified personnel and to operate under reliable procedures, effective quality control and quality assurance programs, and qualified supervision. #### Regulation .02 Scope. *COMAR 10.10.01.02* A. This subtitle contains the standards and requirements that a medical laboratory shall meet to: (1) Obtain and retain a license to offer to perform or perform tests on human specimens; and (2) Certify chemists and analysts in crime laboratories to perform approved testing procedures for controlled dangerous substances. B. This subtitle does not apply to: (1) A research facility that tests human specimens and does not: (a) Report any patient-specific test results for use in connection with the diagnosis and control of human disease or the assessment of the health, nutritional, or medical condition or job-related alcohol and controlled dangerous substances evaluation of individual patients or clients, or (b) Provide test results to the patient, the patient's family, or a health care provider; (2) A medical laboratory operated by the federal government, unless the laboratory or tissue bank is directed by a federal agency to meet the requirements of this subtitle; and (3) A crime laboratory operated by the federal government. #### Regulation .03 Definitions. *COMAR 10.10.01.03* A. In this subtitle, the following terms have the meanings indicated. B. Terms Defined. (1) Accuracy or Accurate. (a) “Accuracy” or “accurate” means the degree of agreement between the determination of a quantity and its true value. (b) “Accuracy” or “accurate” includes the quality of a test result as it relates to the analytic phase of the testing process when the test result: (i) Conforms exactly to a standard; or (ii) Deviates only within established limits from a standard. (2) “Alternative sanction” means a directed plan of correction or a limitation placed on testing. (3) “Analyte” means a substance or constituent for which a laboratory conducts testing. (4) “Analytical system” means a test system's methods, procedures, instruments, equipment, kits, reagents, and supporting materials used to detect or measure an analyte or perform a test. (5) Authorized Person. (a) “Authorized person” means an individual allowed to request a laboratory test. (b) “Authorized person” is limited to those individuals identified under COMAR 10.10.06.02. (5-1) “Buccal cavity” means the vestibule of the mouth, specifically the area lying between the teeth and cheeks. (5-2) “Buccal swab” means a specialized applicator with a sponge, cotton, or Dacron tip, used to collect epithelial cells for DNA testing by rubbing the applicator tip on the inside of the cheek in the buccal cavity. (6) “Calibrator” means a material having a known value or concentration that is used to standardize an analytical system. (7) “CDC” means the Centers for Disease Control and Prevention. (8) “Certified analyst” means an individual who: (a) Meets the qualifications established under COMAR 10.10.09.01B and .02C; and (b) Is thereby permitted to identify marijuana or marijuana products, or both, using procedures approved under COMAR 10.10.09.04. (9) “Certified chemical analyst” means an individual who: (a) Meets the qualifications established under COMAR 10.10.09.01A and .02B; and (b) Is thereby permitted to identify marijuana or marijuana products, or both, cocaine base, cocaine hydrochloride, and heroin using procedures approved under COMAR 10.10.09.04. (10) “Certified chemist” means an individual who: (a) Meets the qualifications established under COMAR 10.10.09.01A and .02A; and (b) Is thereby permitted to identify any controlled dangerous substance using procedures approved under COMAR 10.10.09.04. (11) “CFR” means the Code of Federal Regulations. (12) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 in Section 353 of the Public Health Service Act and any amendments to it (42 U.S.C. §263a). (12-1) “CLIA waived test” means a test system, assay, or examination that the federal Department of Health and Human Services has determined meets the Clinical Laboratory Improvement Amendments (CLIA) statutory criteria as specified for waiver under the federal CLIA Amendments of 1988 in Section 353 of the Public Health Service Act of 42 U.S.C. §263a. (13) “CMS” means the federal Centers for Medicare and Medicaid Services. (14) “Collection station” means a site other than a laboratory where specimens are gathered before being shipped elsewhere for laboratory testing. (15) “Complaint investigation” means an investigation of a laboratory, including an on-site survey, initiated in response to a complaint. (16) “Control sample” means a material, solution, or lyophilized preparation used in laboratory quality control, the concentration of which is within certain specified and known limits. (17) “Controlled dangerous substance” means any drug, substance, or immediate precursor in Schedules I through V of Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. (18) “Deficiency” means a situation or finding of statutory or regulatory noncompliance. (19) “Department” means the Maryland Department of Health. (20) “Directed plan of correction” means a set of corrective actions stipulated by the Secretary that a laboratory shall implement to effect statutory or regulatory compliance. (21) Discipline. (a) “Discipline” means a scientific field of study in which a laboratory is licensed to offer to perform or perform tests. (b) “Discipline” includes: (i) Chemistry, including the subdisciplines of blood gas analysis, endocrinology, radioimmunoassay, routine chemistry, toxicology, and urinalysis; (ii) Forensic toxicology, including job-related alcohol and controlled dangerous substances, limited to the detection of alcohol or a controlled dangerous substance for a non-therapeutic or non-diagnostic, job-related purpose. (iii) Genetics, including the subdisciplines of biochemical genetics, cytogenetics, medical genetics, and molecular genetics; (iv) Health awareness testing, which is limited to health awareness tests set forth in §B(27) of this regulation; (v) Hematology, including the subdisciplines of coagulation testing, hemoglobinopathy screening, and routine hematology; (vi) Immunology, including the subdisciplines of serology, immunohematology, and histocompatibility; (vii) Microbiology, including the subdisciplines of bacteriology, mycobacteriology, mycology, parasitology, and virology; (viii) Molecular biology, including nucleic acid probes; nucleic acid target, probe, and signal amplifications; recombinant nucleic acid techniques; and other techniques of applied molecular genetics other than cytogenetics used in connection with the diagnosis and control of human disease or the assessment of human health; and (ix) Pathology, including the subdisciplines of gynecologic cytology, dermatopathology, and histopathology. (22) “Examinee” means an individual: (a) Whose specimen is collected or tested by a laboratory; or (b) Who is subject to a proficiency test in gynecologic cytology. (23) “Excepted laboratory” means a medical laboratory that offers to perform or performs tests limited to one or more excepted tests. (24) “Excepted test” means a medical laboratory test that is a CLIA waived test. (25) “Exfoliative” means falling off in scales or layers. (26) General Supervisor. (a) “General supervisor” means a technologist who possesses at least 4 years technical experience in a licensed medical laboratory other than an excepted laboratory. (b) “General supervisor” includes an individual who qualified as a supervisory technologist under previous State regulations. (27) “HDL-C” means high density lipoprotein cholesterol. (28) Health Awareness Test. (a) “Health awareness test” means a test approved by the Secretary to be performed at a temporary or mobile laboratory, such as a health fair in a shopping mall. (b) “Health awareness test” is limited to tests that: (i) Are performed solely for the purposes of screening for certain medical conditions and are not to be used for diagnostic or management of healthcare conditions; (ii) Are performed on a CLIA waived testing device; and (iii) Measure glucose, lipids, or other clinical values which the Secretary has concluded are in the interest of public health to be measured at a health awareness event. (29) “Immediate jeopardy” means a deficiency that poses immediate danger to public health or safety and requires the Secretary to take immediate action to remove the jeopardy. (30) “Immediate precursor” means a substance that the Department has found to be, and by regulation designates as being, the principal compound commonly used or produced primarily for use and that is an immediate chemical intermediary used or likely to be used in the manufacture of a controlled dangerous substance, the control of which is necessary to prevent, curtail, or limit that manufacture. (31) “Laboratory” means a medical laboratory. (32) “Letter of exception” means a license issued by the Secretary authorizing the operation of a laboratory to offer to perform or perform one or more excepted tests. (33) “Letter of exception—limited testing for rare diseases” means a license issued by the Secretary authorizing the operation of a laboratory to offer to perform or perform testing limited to one or more rare disease tests. (34) “License” means a permit, letter of exception, certificate, or other document issued by the Secretary granting approval or authority to: (a) Offer to perform or perform medical laboratory tests or examinations in this State; (b) Offer to perform or perform medical laboratory tests or examinations on specimens acquired from health care providers in this State at a medical laboratory located outside this State; or (c) Represent or service in this State a medical laboratory regardless of the laboratory's location. (35) “Licensed laboratory” means a laboratory operating under a license issued by the Secretary. (36) “Licensee” means a person who holds a license under this chapter to operate a laboratory. (37) “Limited public health testing” means testing limited to a combination of 15 or fewer excepted tests performed by a nonprofit organization or a State, county, or local health department. (38) “Marginal proficiency testing performance” means failure to attain the minimum satisfactory score for two of three consecutive proficiency testing events. (39) Medical Laboratory. (a) “Medical laboratory” means a facility, entity, or site that offers to perform or performs tests in connection with: (i) The diagnosis and control of human disease; (ii) The assessment of human health, nutrition, or medical conditions; or (iii) Job-related testing. (b) “Medical laboratory” includes but is not limited to a: (i) Physician office laboratory; (ii) Point-of-care laboratory; (iii) Laboratory owned or operated by the State, a county, or a municipal health department; (iv) Not-for-profit laboratory; (v) Hospital laboratory; and (vi) Commercial laboratory. (40) Method Verification. (a) “Method verification” means evaluation of an analytical system by assessment of each analytical system component, including instrument, test strip, cartridge, card, and kit reagent. (b) “Method verification” includes but is not limited to the determination of: (i) An analytical system's reportable range; (ii) Accuracy; and (iii) Within-run and run-to-run precision. (41) “Mobile laboratory” means a laboratory located in a moveable vehicle, such as a truck, trailer, van, or ambulance. (42) “Multi-site permit” means a permit available to the State, a county, or a municipal health department authorizing the operation of limited public health testing at more than one mobile or permanent laboratory. (43) “Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health, formerly the Licensing and Certification Administration (LCA). (44) “Operator of an analytical system” means an individual who applies a test specimen or control sample to an analytical system and performs the necessary operative steps to isolate or identify an infectious agent or measure an analyte. (45) “Owner” means a person who possesses a financial interest in a laboratory. (46) “Patient of the practice” means an individual who accepts referral to or is seen or otherwise examined by a member or members of a practice of medicine. (47) Permit. (a) “Permit” means a license issued by the Secretary authorizing a person to operate a medical laboratory conducting one or more tests that are not excepted tests. (b) “Permit” includes a: (i) Provisional permit; and (ii) Temporary permit. (48) “Permitted laboratory” means a licensed laboratory operating under a permit. (49) “Phlebotomist” means an individual who procures a blood specimen by venipuncture, arterial puncture, or capillary sampling. (50) “Physician” means a doctor of medicine or a doctor of osteopathy licensed by the Maryland State Board of Physicians and a doctor of podiatric medicine licensed by the Maryland State Board of Podiatric Medical Examiners. (51) “Physician of a practice” means a physician employed, salaried, or otherwise engaged to operate or function as a member in a medical practice, even if the physician does not have an ownership interest in the practice or the practice's laboratory. (52) “Physician office laboratory (POL)” means a medical laboratory operated by a single practice of medicine, individually or collectively by one or more physicians, that is used solely as an adjunct to the care of patients of the practice. (53) “Point-of-care laboratory (POCL)” means a laboratory operated as part of, or in association with, a medical care facility, such as a hospital, nursing home, community health center, health maintenance organization, county or municipal health department, or a pharmacy. (54) “Practice” means: (a) An individual physician licensed to practice medicine in the State; or (b) A medical partnership, professional association, professional service corporation, or medical corporation of two or more physicians licensed to practice medicine in the State and sharing facilities, personnel, income, or business expenses. (55) “Precision” means the agreement of results among themselves when a specimen or sample is tested multiple times. (56) “Pre-field evaluation” means the assessment of an analytical system before it may be used in a mobile or temporary laboratory. (57) “Primary standard” means a comprehensive general standard or set of standards that: (a) A laboratory must meet to obtain or retain a license to operate; or (b) An individual must meet in order to examine gynecologic cytology specimens. (58) “Principal sanction” means the denial, suspension, or revocation of a license. (59) “Proficiency testing (PT)” means evaluation of an individual's ability to perform laboratory procedures or tests within the PT program's defined limits of accuracy through analysis of unknown samples distributed at periodic intervals by an external source. (60) “Public health laboratory” means a public, nonprofit laboratory solely owned and operated by or for the State, a county, or a municipal health department located in the State. (61) Quality Assurance. (a) “Quality assurance” means a system of established written policies and procedures designed to monitor, review, evaluate, and improve the ongoing and overall quality of the preanalytic, analytic, and postanalytic aspects of laboratory testing. (b) “Quality assurance” includes but is not limited to practices involving: (i) Patient preparation; (ii) Specimen collection, labeling, processing, and transport; (iii) Quality control strategies, practices, and results; (iv) Record keeping; (v) Personnel training and competency; (vi) Continuing education; (vii) Proficiency testing; (viii) Remedial and corrective actions; and (ix) Analytical system evaluation, validation, and verification. (62) Quality Control. (a) “Quality control” means established written policies and procedures designed to ensure reliable laboratory testing by monitoring, reviewing, and evaluating the analytic aspects of laboratory testing. (b) “Quality control” includes but is not limited to policies and procedures that detect, monitor, review, and evaluate the: (i) Accuracy and precision of the analytic phase of a testing process; (ii) Changes in the chemical, electronic, optical, or mechanical components of an analytical system; (iii) Deterioration of reagents, materials, or supplies used in a testing process; and (iv) Personnel practices during a testing process. (63) “Quality control test” means an examination performed on an external test sample that: (a) Is not part of the analytical system; (b) Contains a known quantity of the analyte being tested; (c) Is similar in its physical characteristics and constituents to patient specimens tested by the system; and (d) Reacts with all system components in the same way as a patient specimen. (64) “Rare disease” means: (a) A disabling, chronically debilitating, or life-threatening disease or condition that has fewer than 200,000 affected individuals in the United States, which is equivalent to: (i) A prevalence of fewer than one individual per 2,000 individuals in the population; or (ii) An incidence of fewer than one affected individual per 10,000 individuals in the population; (b) A disabling or life-threatening disease or condition that is listed as a rare disease by the National Institutes of Health Office of Rare Diseases; or (c) A disabling or life-threatening disease or condition in which more than 200,000 individuals are affected if: (i) A subpopulation of the disease or condition is equal to the prevalence standard for a rare disease in §B(64)(a) of this regulation; or (ii) The incidence of the disease or condition is fewer than five affected individuals per 10,000 in a defined community. (65) Rare Disease Test. (a) “Rare disease test” means a test that is: (i) Performed on a specimen obtained from an individual in order to determine or evaluate whether the individual has a rare disease or condition; (ii) Based on a single method using one sample of a specimen to produce the test result; and (iii) Not routinely offered or performed by a medical laboratory permitted by the Department. (b) “Rare disease test” includes a test with multiple clinical or health evaluation uses such as: (i) Newborn screening; (ii) Carrier screening; (iii) Predictive testing; (iv) Disease diagnosis; or (v) Disease prognosis. (66) “Reliable” means that the quality of a test result meets the quality standards for the preanalytic, analytic, and postanalytic phases of the testing process as set forth in COMAR 10.10.06. (67) “Remeasurement” means repeating the measurement of an analyte. (68) “Sample” means a substance, constituent, or material intended for use in quality control, proficiency testing, or another aspect of a laboratory's quality assurance program. (69) Sanction. (a) “Sanction” means an action that the Secretary may take to effect statutory or regulatory compliance. (b) “Sanction” includes a principal sanction and an alternative sanction. (70) Secretary. (a) “Secretary” means the Secretary of Health or the Secretary's designee. (b) “Secretary” includes the Office of Health Care Quality as a designee. (71) “SOPM” means a standard operating procedure manual. (72) “Specialty” means a scientific field of study within a laboratory subdiscipline, such as compatibility testing within the subdiscipline of immunohematology. (73) “Specimen” means material collected from the human body and intended for laboratory testing. (74) “Standard” means one or more specific technical, procedural, fiscal, or other requirements that a laboratory or individual must meet to comply with this chapter. (75) “Subdiscipline” means a scientific field of study within a laboratory discipline, such as bacteriology within the discipline of microbiology and dermatopathology within the discipline of pathology. (76) Survey. (a) “Survey” means an on-site visit to a laboratory by one or more employees of the OHCQ to carry out or oversee the regulation of medical laboratories. (b) “Survey” includes but is not limited to: (i) Inspection; (ii) Follow-up inspection; (iii) Complaint investigation; and (iv) On-site monitoring. (77) System Check. (a) “System check” means a device that verifies all or part of the chemical, electronic, optical, or mechanical components or constituents of a test system to determine if the test system is functioning properly. (b) “System check” includes chemical, electronic, optical, or mechanical devices, such as a card, tube, or strip that simulates a properly functioning single-use test device. (c) “System check” does not include a quality control test sample or patient specimen. (78) “Technical supervisor” means an individual who is qualified to direct medical laboratory testing in at least one laboratory discipline. (79) “Technician” means an individual who has at least 1 year of experience in a licensed medical laboratory, other than an excepted laboratory, and who has earned: (a) An associate degree in a laboratory science or medical laboratory technology from an accredited college or university; or (b) 60 semester hours of academic credit, including 24 semester credit hours of science that include: (i) 6 semester hours of chemistry, and (ii) 6 semester hours of biology. (80) “Technologist” means an individual who: (a) Possesses a bachelor's degree in a chemical, physical, biological, or clinical laboratory science or in medical technology from an accredited college or university and has at least 1 year of full-time laboratory experience in the discipline in which the individual performs tests; (b) Received a passing score in the United States Department of Health and Human Services proficiency examination for clinical laboratory technologists; or (c) Meets the technologist qualifications set forth in 42 CFR §493.1491, which is incorporated by reference in Regulation .04 of this chapter. (81) “Temporary laboratory” means a medical laboratory located at a temporary testing site, such as a health fair or shopping mall, for fewer than 30 days in 12 consecutive months. (82) “Test” means a medical laboratory examination, analysis, procedure, or preanalytic, analytic, or postanalytic phase of a testing process. (83) “Testing event” means an occasion when a health awareness test is offered or performed on a specified date at a temporary laboratory. (84) “Testing personnel” means an individual or individuals employed or otherwise engaged by a laboratory to perform medical laboratory tests. (85) “Total number of tests” means all tests performed by a laboratory in all disciplines in the previous calendar year. (86) “Unsatisfactory proficiency testing performance” means failure to attain the minimum satisfactory score for three of four consecutive proficiency testing events. (87) “Test System” means the instructions, instrumentation, equipment, and reagents necessary to perform an assay or examination that generates test results. (88) “Validity check” means a procedural, testing process, or analytical verification of proper performance of one or more analytical steps performed by the test system operator, built into a test system, and carried out by a test system to detect environmental damage or interfering substances that may have affected the device or the results of the testing process. #### Regulation .04 Incorporation by Reference. *COMAR 10.10.01.04* A. In this subtitle, the following documents are incorporated by reference. B. Documents Incorporated. (1) 29 CFR §1910.1030, as amended. (2) 29 CFR §1910.1450, as amended. (3) 42 CFR §§493.801—493.959, as amended. (4) 42 CFR §§493.1100—493.1299, as amended. (5) 42 CFR §§493.1405—493.1495, as amended. (6) 49 CFR §40.87, as amended. (7) Forensic Chemists and Analysts Training and Procedure Manual (Maryland Department of Health, 1992). ### Chapter 02 — Medical Laboratories — General **Authority:** Courts and Judicial Proceedings Article, §10-1001; Health General Article, §§17-201, 17-202, 17-205, 17-214, and 17-501, Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .01E adopted effective January 21, 2002 (29:1 Md. R. 23) **Administrative History:** Regulation .01E amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .01F adopted effective August 29, 2005 (32:17 Md. R. 1438) **Administrative History:** Regulation .01F amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .02 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02C amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) #### Regulation .01 Responsibilities of the Department. *COMAR 10.10.02.01* A. The OHCQ. The OHCQ shall conduct surveys, as set forth in this subtitle, of laboratories that obtain or retain a license. B. Surveys. The OHCQ shall: (1) Conduct or oversee an announced or unannounced survey of a laboratory at any time during its hours of operation to assess compliance with applicable sections of Health-General Article, Title 17, Subtitles 2 and 5, Annotated Code of Maryland, and this chapter; and (2) Examine, as part of a survey, a laboratory's facilities, equipment, quality assurance records and procedures, operating procedures, personnel and personnel records, proficiency testing, patient reports, and other records and files pertinent and subject to this subtitle. C. Issuance of Licensing Documents. The OHCQ shall: (1) License a person to operate a laboratory by issuing a letter of exception or permit when the laboratory is in compliance with the applicable standards set forth in this subtitle; (2) Issue a license that includes the: (a) Name of the laboratory; (b) Name of the licensee or laboratory director; and (c) Name of the laboratory owner. (3) Issue a license that designates: (a) The classes of services, that is, disciplines, provided; (b) The tests or examinations offered; or (c) Both §C(3)(a) and (b) of this regulation. D. Administration and Information Management. The OHCQ shall: (1) Maintain a list of licensed laboratories; (2) Document information regarding denial, suspension, or revocation of a license and submit this documentation to the Secretary; (3) Monitor the proficiency testing performance of a laboratory required to participate in proficiency testing; and (4) For tests that are not CLIA waived, impose alternative sanctions and initiate actions leading to imposition of principal sanctions against a laboratory under the appropriate provisions of this subtitle. E. Recommending Excepted Test Status. #### Regulation .02 Accredited Laboratory and Accrediting Organization. *COMAR 10.10.02.02* A. Accredited Laboratory — Determination. The Secretary shall accept as meeting the survey requirements of this chapter a laboratory accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the laboratory's accrediting organization are equivalent to those under this subtitle. B. Accredited Laboratory — Requirements. In addition to meeting the requirements for its certificate of accreditation, as set forth by its accrediting organization, an accredited laboratory shall: (1) Obtain and maintain a valid license issued by the Secretary; and (2) Be subject to survey by the OHCQ for the purpose of investigating complaints or validating findings of the laboratory's accrediting organization. C. Accrediting Organization. (1) A private, nonprofit laboratory accrediting organization may inspect and accredit laboratories in the State for the purpose of Maryland State licensure only after applying for and receiving approval of the OHCQ. (2) The OHCQ shall base approval of a laboratory accrediting organization on a review of that organization, when the review includes but is not limited to an evaluation of: (a) Documentation of current accrediting status issued by CMS and of compliance with CMS reporting requirements; (b) Accreditation policies and standards; (c) Copies of survey forms and guidelines; (d) Surveying and deficiency writing policies; (e) Surveyor qualifications; (f) Complaint investigation policies; (g) Proficiency test monitoring policies; (h) Procedures the accrediting organization will follow when notifying the OHCQ that the organization: (i) Is denying, withdrawing, suspending, or revoking a laboratory's accreditation; (ii) Finds serious patient jeopardy or identifies a hazard to public safety; (iii) Accredits a new laboratory; (iv) Imposes an adverse or corrective action on a laboratory; or (v) Is initiating a complaint investigation; and (i) The accrediting organization's compliance with the requirements of §C of this regulation. (3) In addition to requirements set forth elsewhere in this regulation, an accrediting organization shall: (a) Provide to the OHCQ: (i) Annually, an updated list containing the names, addresses, and accreditation expiration dates of all accredited laboratories in the State; (ii) Within 30 days after conducting a survey, a certified written or electronic copy of each survey report covering each laboratory applying for or maintaining accreditation in the State; (iii) Written notice of any proposed change to requirements for laboratory accreditation, at least 30 days before the effective date of the change; (iv) Within 30 days after a laboratory's certificate of accreditation expires, written or electronic notice when the laboratory does not renew its certificate; and (v) Within 24 hours after taking an action, telephonic or electronic notice whenever an accredited laboratory's certificate of accreditation is limited, suspended, revoked, or surrendered; (b) Evaluate compliance, when applicable, with State regulations pertaining to: (i) Cholesterol testing; (ii) Gynecological cytology; (iii) Dermatopathology; (iv) Forensic toxicology; (v) Laboratory reporting of test results covering contagious disease, blood lead, cancer, and other tests as required by law or regulation; (vi) Proficiency testing; (vii) Special medical waste disposal; and (viii) Testing performed at a temporary or mobile laboratory; (c) Evaluate compliance with State regulations by: (i) Employing a checklist provided by the Department; (ii) Incorporating an evaluation of compliance with State regulatory requirements into its own survey process; or (iii) Demonstrating that its existing survey process adequately evaluates compliance with State regulations; and (d) On request, provide to OHCQ a copy of: (i) A complaint investigation; (ii) Surveyor qualifications; (iii) A change in a laboratory's disciplines, subdisciplines, or specialties; and (iv) Other information the Secretary may require relating to approval of a laboratory accrediting organization. #### Regulation .03 Surveys. *COMAR 10.10.02.03* A. General. (1) A licensee shall allow an on-site survey by the OHCQ or, when applicable, by the laboratory's approved accrediting organization, at any time during the laboratory's normal hours of operation, to evaluate the laboratory's compliance with the applicable requirements, conditions, and standards of this subtitle. (2) A survey may include but is not limited to: (a) Observation and examination of laboratory facilities; (b) Equipment; (c) Quality assurance and quality control program records; (d) Operating procedures; (e) Personnel; (f) Personnel records; (g) Proficiency testing; (h) Patient reports; and (i) Other records and files pertinent to this subtitle. (3) Laboratory employees shall make data and records accessible within a reasonable time during the on-site survey. B. Excepted Laboratory. A licensee operating a laboratory under a letter of exception, other than a mobile or temporary laboratory, is: (1) Not subject to routine, on-site surveys; (2) Subject to surveys resulting from complaints or periodic validations, or both, conducted by the Secretary or CMS, or both, to determine regulatory compliance; and (3) Required to make available, pursuant to a survey, records the Secretary may reasonably require to determine regulatory compliance. C. Permitted Laboratory. A licensee operating a laboratory under a permit shall: (1) Be subject to routine surveys conducted by OHCQ; (2) Undergo a routine annual survey for 2 consecutive years after the laboratory: (a) Begins operating; (b) Undergoes a change in ownership; (c) Fails to complete or submit to the Department an acceptable quality assurance self-assessment on forms provided by the OHCQ; or (d) Has imposed on it a principal or alternative sanction; and (3) Undergo a routine biennial survey when the laboratory: (a) Does not fall under one of the categories set forth in §C(2) of this regulation; and (b) Completes and submits to the OHCQ an acceptable quality assurance self-assessment on forms provided by the OHCQ on the years when the OHCQ does not conduct an on-site survey, except as provided in §D of this regulation. D. Accredited Laboratory. An accredited laboratory: (1) Undergoing routine on-site surveys conducted by an accrediting organization approved by the Secretary, except as provided in §D(2) and (3) of this regulation, is not subject to routine surveys conducted by the OHCQ; (2) Is subject to surveys conducted by the OHCQ to investigate a complaint or to determine regulatory compliance; and (3) Holding a permit in the discipline of forensic toxicology, subdiscipline of job-related testing, is subject to routine surveys of the laboratory's alcohol and controlled dangerous substances testing areas conducted by the OHCQ. E. Temporary or Mobile Laboratory. The OHCQ may survey each testing event site when a temporary or mobile laboratory licensee offers to perform or performs testing services. F. Excepted Laboratory — Limited Testing for Rare Diseases. A licensee operating a laboratory under a letter of exception — limited testing for rare diseases is subject to the survey requirements stated in §B of this regulation. ### Chapter 03 — Medical Laboratories — Licenses **Authority:** Environment Article, §6-303; Health-General Article, §§2-104(b), 17-202, 17-205—17-210, 17-212, 17-502, 17-503, 17-505, and 17-510; Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340); July 23, 2001 (28:14 Md. R. 1321) **Administrative History:** Regulation .01A amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .01E adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02 amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787); April 13, 2015 (42:7 Md. R. 568) **Administrative History:** Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .02B amended as an emergency provision effective November 1, 2004 (31:25 Md. R. 1789); amended permanently effective January 6, 2005 (31:26 Md. R. 1863); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .02B amended effective August 29, 2005 (32:17 Md. R. 1438); February 22, 2010 (37:4 Md. R. 341); April 16, 2012 (39:7 Md. R. 492); November 12, 2012 (39:22 Md. R. 1428); April 1, 2013 (40:6 Md. R. 473); March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .02C amended effective November 12, 2012 (39:22 Md. R. 1428) **Administrative History:** Regulation .03C amended effective June 1, 2009 (36:11 Md. R. 787); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04B, E amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .05 adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .06 adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .06A amended effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 General. *COMAR 10.10.03.01* A. Requirement. (1) General. A person shall possess a license before: (a) Offering to perform or performing a medical laboratory test or examination in this State; (b) Offering to perform or performing a medical laboratory test or examination on a specimen acquired from a health care provider in this State at a laboratory located outside this State; or (c) Representing or servicing in this State a laboratory regardless of the laboratory's location. (2) Prohibited Tests. The Secretary may impose principal and alternative sanctions as set forth in COMAR 10.10.08.01A if a person offers to perform or performs a test or part of a test, including the use of a reagent, supply, procedure, technique, kit, or equipment, that: (a) Does not produce accurate or reliable results as evidenced by documented, independent scientific testing and evaluation; or (b) Lacks proof of efficacy substantiated by an independently conducted and documented scientifically based clinical trial. (3) Cholesterol Testing Plan for Health Departments. (a) A local or county health department intending to perform cholesterol testing outside a permanently located laboratory may submit to the Secretary a cholesterol testing plan instead of applying for a cholesterol testing permit. (b) If the submitted plan meets applicable standards under this chapter, the Secretary may waive the permit requirement for a cholesterol testing permit. (c) If the plan does not meet the applicable standards of this chapter, the local or county health department shall apply for a permit as set forth in this chapter. B. Limitation. A person may not operate a laboratory in a discipline other than what is listed on the license. C. Eligibility. A person meeting the requirements and standards of this chapter may apply for one or more of the following licenses: D. Issuance. (1) Provisional Permit. (a) The Secretary may issue a provisional permit before or after conducting an initial survey and pending determination of compliance with the standards in this chapter. (b) A provisional permit is valid for not more than 180 days and may not be renewed. (2) Letter of Exception and Permit. The Secretary may issue a letter of exception or permit that: (a) Is valid for not more than 2 years from the date of issue; and (b) Shall be renewed before its date of expiration if a person intends to operate the laboratory in the succeeding permit period. (3) Single-Site and Multi-Site Licenses. (a) Except as set forth in §D(3)(b) of this regulation, a person shall obtain a separate, single-site license for each location at which a laboratory performs a test. (b) The Secretary may issue a multi-site license to a person operating: (i) A mobile laboratory using the address of its home base or main administrative office in the State; (ii) A nonprofit laboratory or public health laboratory performing limited public health testing; and (iii) Hospital laboratories located at the same street address or within contiguous buildings and under common direction. E. In order to maintain a State license issued by the Department pursuant to this subtitle, a licensee shall be in compliance with all applicable federal, State, and local laboratory requirements. #### Regulation .02 Letters of Exception. *COMAR 10.10.03.02* A. Eligibility. (1) An individual directing a POL or POCL who offers to perform or performs tests limited to one or more excepted tests may obtain a letter of exception instead of a permit to offer to perform or perform those tests. (2) An individual eligible for a letter of exception shall: (a) Be qualified as a laboratory director as set forth in 42 CFR §493.1405, including: (i) Being a doctor of medicine or doctor of osteopathy licensed in the State and having laboratory training or experience appropriate for the testing performed; or (ii) Holding an earned doctoral, master's, or bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution; (b) Provide evidence of training in the performance and interpretation of excepted tests and be licensed in the State as a: (i) Nurse midwife; (ii) Nurse practitioner; (iii) Physician assistant; (iv) Chiropractor; (v) Podiatrist; (vi) Dentist; or (vii) Pharmacist; or (c) Be clinical staff who: (i) Meets the qualifications set forth in COMAR 10.47.01.06D; (ii) Is employed by a substance abuse treatment program that is certified or accredited in accordance with COMAR 10.47.04.03; and (iii) Is authorized to order tests to detect the presence of controlled dangerous substances on patients enrolled in the substance abuse treatment program. (3) A person operating a temporary medical laboratory to perform health awareness tests, regardless of testing site location, is not eligible for a letter of exception. B. Excepted Tests. A POL or POCL operating under a letter of exception may perform one or more CLIA waived tests. C. Reporting Requirements for Whole Blood Lead Testing on a CLIA Waived Analyzer. (1) The blood tests for lead shall: (a) Be reported under this regulation in the format approved by the Maryland Department of the Environment; and (b) Include the information required by this regulation. (2) The blood tests for lead to be reported shall include the following information: (a) Demographic information including: (i) Name, including first, last, middle initial; (ii) Date of birth, sex, and race; (iii) Complete home address at the time the blood specimen was drawn including house or apartment number, street, city, county or town, zip code, and state; (iv) Telephone number; and (v) Parent or guardian name; (vi) Residential status, for example, whether parent or guardian owns their home or rents; (b) Type of specimen, either venous or capillary, and date the specimen was drawn; (c) Clinic or practice name, address, and telephone number; (d) Draw site name and address, if different from clinic or practice; (e) Blood lead level in micrograms per deciliter; and (f) Any additional information as may be required by the Maryland Department of the Environment. D. Regulatory Requirements. An individual required to obtain a license to operate a laboratory who chooses to operate under a letter of exception shall: (1) Obtain, complete, and file an application as prescribed in Regulation .04 of this chapter; and (2) Comply with good laboratory practices that include: (a) Following the manufacturer's instructions for instrument or test system operation and test performance; (b) Having a procedure manual describing the processes for performing tests and reporting patient test results; (c) Performing and documenting quality control procedures using applicable levels of control materials each day of testing; (d) Performing and documenting that remedial action has been taken when problems or errors are identified; (e) Documenting lot numbers of all quality control reagents used; and (f) Performing and documenting test system function for instruments with internal quality controls on each day of testing. #### Regulation .03 Permits. *COMAR 10.10.03.03* A. Requirement. A person operating a medical laboratory that performs one or more tests other than excepted tests shall obtain and renew a laboratory permit as required in this chapter. B. Tests Other than Excepted Tests. (1) A test other than an excepted test is one not listed in Regulation .02B of this chapter. (2) A person holding a permit may perform both excepted tests and tests other than excepted tests. C. Regulatory Requirements. A person operating a medical laboratory under a permit shall: (1) Obtain, complete, and submit permit applications as prescribed in this chapter and COMAR 10.10.04; (2) Comply with the survey requirements set forth in this subtitle; (3) Comply with the applicable quality assurance and quality control requirements required in COMAR 10.10.06; (4) Comply with the applicable proficiency testing requirements required in COMAR 10.10.05; and (5) Comply with the applicable personnel requirements required in COMAR 10.10.06.15B and 10.10.07. #### Regulation .04 Letter of Exception and Permit — Administrative Procedures. *COMAR 10.10.03.04* A. Application — Filing. (1) Except for a laboratory eligible for a multi-site license as set forth in Regulation .01D(3)(b) of this chapter, a person shall apply for a license for each laboratory location. (2) A person holding a license to operate a laboratory in the discipline of chemistry or health awareness testing is not required to obtain a separate cholesterol testing permit to conduct cholesterol testing at a temporary laboratory site if the licensee complies with the requirements applicable to a temporary laboratory as set forth in this subtitle. (3) A person shall complete and file an application for a license using forms provided by the OHCQ. (4) A person shall complete on the application a description of laboratory services, which includes but is not limited to: (a) Types of tests performed or to be performed; (b) Total number of tests performed or to be performed annually, excluding tests for quality control and proficiency testing; and (c) Qualifications of personnel who direct, supervise, and perform laboratory testing. (5) The laboratory director shall sign the application forms attesting that the information provided is accurate and that the laboratory is or will be operated in accordance with the requirements and standards required in this chapter. B. Application — Evaluation and Billing. (1) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if an application is complete. (2) The OHCQ shall review and evaluate an application in accordance with the standards and requirements of this subtitle to determine if the laboratory is eligible for a: (a) Letter of exception; (b) Letter of exception — limited testing for rare diseases; or (c) Permit. C. Application — Denial of License. If the OHCQ determines that a laboratory is not in compliance with the requirements of this chapter and therefore cannot be issued a license, the OHCQ shall provide to the laboratory: (1) A written statement of the grounds on which the denial is based; and (2) The opportunity to: (a) Amend and resubmit the application; or (b) Request, in writing, an opportunity for a hearing as provided in the Administrative Procedure Act, State Government Article, §§10-201—10-226, and Health-General Article, §§17-210 and 17-509, Annotated Code of Maryland. D. Notification Requirements. A licensee shall notify the OHCQ within 30 days of a change in laboratory: (1) Ownership; (2) Name; (3) Location; or (4) Director. E. Amending a Permit. Except as prescribed in §D of this regulation, a licensee holding an unexpired permit who wishes to amend it shall: (1) Submit a written request for amendment to the Secretary; and (2) Obtain written approval from the OHCQ before implementing the amendment. F. Non-Transferability. A license is not transferable between laboratories, directors, or locations. G. Letter of Exception. A person applying for a letter of exception for a POL or POCL shall submit an initial application. H. Letter of Exception — Limited Testing for Rare Diseases. A person applying for a letter of exception—limited testing for rare diseases for a laboratory shall submit an initial application. #### Regulation .05 Letter of Exception — Limited Testing for Rare Diseases. *COMAR 10.10.03.05* A. The Secretary may waive the permit requirements under this subtitle for a laboratory that offers to perform or performs a rare disease test if the laboratory: (1) Meets the requirements of Regulations .05 and .06 of this chapter; and (2) Obtains and maintains a letter of exception — limited testing for rare diseases. B. Eligibility. A person operating a medical laboratory may be eligible for a letter of exception — limited testing for rare diseases if the laboratory: (1) Is operated as: (a) A not-for-profit entity; or (b) Part of an accredited educational institution; (2) Performs not more than a total of 50 tests per year for a specific rare disease on specimens from Maryland patients; (3) Offers to perform or performs only rare disease tests as defined in COMAR 10.10.01.03B; (4) Possesses a valid CLIA certificate for the complexity of the testing performed; (5) Does not possess a Maryland permit for offering to perform or performing medical laboratory testing; and (6) Meets the requirements for a laboratory to operate under a letter of exception — limited testing for rare diseases. C. Research Laboratory. A research laboratory may obtain a letter of exception — limited testing for rare diseases if the laboratory meets the eligibility requirements of §B of this regulation. #### Regulation .06 Letter of Exception — Limited Testing for Rare Diseases; Standards and Requirements. *COMAR 10.10.03.06* A. Application Requirements and Testing Approval. A person required to obtain a license to operate a laboratory that chooses to operate under a letter of exception — limited testing for rare diseases shall: (1) Submit: (a) A completed: (i) Application as prescribed in Regulation .04 of this chapter; and (ii) Report or questionnaire as required by the Secretary to determine regulatory compliance; (b) A copy of the laboratory's: (i) Current CLIA certificate issued by CMS; and (ii) Most recent CLIA survey report; (c) Documentation of the rare disease testing offered or performed, including but not limited to: (i) The test procedure, including instructions for quality control and quality assurance; (ii) A description of the disease or condition; (iii) An explanation of the clinical validity of the test; (iv) The performance characteristics of the test; (v) The expected turnaround time for patient test results; and (vi) Additional information necessary for determining eligibility and compliance with this subtitle; and (2) Agree to: (a) Make records and reports available to the Department as the Secretary may require; (b) Notify the Department when a change to a licensee's rare disease testing procedure occurs for the purpose of the Department's determining whether the change is in compliance with this subtitle; (c) Perform not more than 50 rare disease tests each year on specimens from Maryland patients; and (d) Submit to the Department statistics that detail the number and types of rare disease tests performed each year on specimens from Maryland patients. B. Standards. A person that wishes to obtain and maintain a letter of exception — limited testing for rare diseases shall: (1) Comply with good laboratory practices that include: (a) Following the manufacturer's instructions for instrument or test system operation and test performance; (b) Having and following a written procedure manual describing the processes for performing tests and reporting patient test results; (c) Performing applicable instrument calibration procedures at least once every 6 months; (d) Performing and documenting quality control procedures using applicable levels of control materials each day of testing; and (e) Performing and documenting that remedial action has been taken when problems or errors are identified; and (2) Meet the requirements and standards in this subtitle applicable to a permitted laboratory including: (a) Proficiency testing under COMAR 10.10.05; (b) Quality assurance under COMAR 10.10.06; (c) Personnel under COMAR 10.10.07; (d) Sanctions under COMAR 10.10.08; and (e) CLIA regulations incorporated by reference at COMAR 10.10.01.04B(3) — (5). C. If the submitted application and explanatory documentation do not meet the requirements of this regulation or if the information submitted for the plan is insufficient to make a determination of compliance with this subtitle, a person may: (1) Submit amendments to the application and explanatory documentation; or (2) Apply for a permit in accordance with this subtitle. D. The OHCQ may conduct on-site surveys of a laboratory operating under a letter of exception — limited testing for rare diseases to: (1) Investigate a complaint; or (2) Determine compliance with this subtitle. E. If a licensee wishes to perform more than 50 rare disease tests per year, the licensee shall submit an application for and obtain a permit as required under this subtitle. ### Chapter 04 — Medical Laboratories **Authority:** Health-General Article, §§17-202, 17-204, 17-205, 17-207, 17-209, 17-502, 17-503, and 17-506, Annotated Code of Maryland **Administrative History:** Effective date: February 19, 1990 (17:3 Md. R. 297) **Administrative History:** Regulation .01 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .03B amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .05 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .06 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .07 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .08E amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .09 amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulation .12B and C amended effective December 9, 1991 (18:24 Md. R. 2644) **Administrative History:** Regulations .01—.12 repealed and new Regulations .01—.19 adopted effective February 26, 1996 (23:4 Md. R. 273) **Administrative History:** Chapter, Cholesterol Testing, repealed and new chapter, Medical Laboratories — Fees, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02 amended effective July 23, 2001 (28:14 Md. R. 1321); June 1, 2009 (36:11 Md. R. 787); August 19, 2013 (40:16 Md. R. 1344); December 21, 2015 (42:25 Md. R. 1543) **Administrative History:** Regulation .03A amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Chapter, Medical Laboratories — Fees renamed Medical Laboratories effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .01E amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .02 amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .03 repealed effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Chapter repealed effective March 1, 2026 (52:24 Md. R. 1198) ### Chapter 05 — Medical Laboratories — Proficiency Testing **Authority:** Health-General Article, §§17-202 and 17-211, Annotated Code of Maryland **Administrative History:** Effective date: October 5, 1998 (25:20 Md. R. 1529) **Administrative History:** Chapter, Job-Related Alcohol and Controlled Dangerous Substances Testing, repealed and new chapter, Medical Laboratories — Proficiency Testing, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04D amended effective November 29, 2010 (37:24 Md. R. 1658) **Administrative History:** Regulation .05A, B amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .05B, C amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05C amended effective November 29, 2010 (37:24 Md. R. 1658) #### Regulation .01 Participation and Evaluation. *COMAR 10.10.05.01* A. Participation. A licensee operating under a permit shall ensure that the laboratory: (1) Enrolls in and participates satisfactorily in a PT program that meets the criteria set forth in this chapter for each of the tests that the laboratory offers to perform or performs; (2) Tests PT samples in the same manner and number of times that it routinely tests patient specimens; and (3) Complies with the applicable standards contained in 42 CFR §§493.801—493.807. B. Evaluation — General. When a PT program does not evaluate a participating laboratory's PT results or the evaluated PT results are inconsistent with satisfactory performance, the participating laboratory and the OHCQ shall evaluate the PT results by comparing them to the all-method-results mean, all-instrument-results mean, or the all-participant-results mean found in the PT program's summaries of PT results. C. Evaluation — Departmental. (1) Administrative Procedures. (a) Submission of Results. The OHCQ shall monitor for regulatory purposes only official results sent directly from the PT program. (b) Multiple Programs. If a licensee enrolls in more than one PT program and duplicate testing and reporting occurs, the licensee shall notify the OHCQ which PT program is to be scored for regulatory purposes. (c) Sample Testing. A licensee shall operate under the following PT procedures: (i) PT samples shall be tested each time a shipment is received and for only those procedures offered or allowed under a laboratory's license; (ii) If a test is no longer offered or performed, the licensee shall inform the OHCQ in writing; (iii) PT samples shall be tested only in the laboratory for which they are intended; (iv) PT samples shall be handled, processed, and tested in the same manner as patient specimens; and (v) Repeat testing may not be performed on PT samples unless it is the laboratory's policy to test patients in duplicate or if abnormal test results are routinely repeated to verify accuracy. (d) Testing and Reporting Deadlines. (i) A licensee shall test PT samples and report PT results within the time limits set by the PT program. (ii) PT results submitted late by a licensee are deemed unsatisfactory by the PT program and the OHCQ. (e) PT Program Evaluation Errors. A licensee is responsible for seeing that an evaluation error on the PT report is corrected by the PT program and that the program sends a corrected PT report to the OHCQ. (f) Performance Records. A laboratory's marginal or unsatisfactory PT performance may not be changed to reflect satisfactory performance when: (i) PT results are not submitted; (ii) PT results are submitted after the due date; or (iii) Transcription errors involving PT results went unnoticed until the evaluated results were scored. (2) Evaluation Procedures. (a) Grading Criteria. (i) The PT program shall score test results in terms of correlation with reference or referee laboratory test results, target values, or statistical methods based on means and standard deviations. (ii) The OHCQ shall determine a laboratory's PT performance based on a PT program's numerical score for each specialty, subspecialty, constituent, analyte, and culture type. (b) Scores. Numerical PT scores required for satisfactory performance in each subdiscipline, specialty or subspecialty are as follows: (i) AFP for NTD, equal to or greater than 80 percent; (ii) Antibodies for HIV, equal to or greater than 80 percent; (iii) Bacteriology, equal to or greater than 80 percent; (iv) Blood gases, equal to or greater than 80 percent; (v) Blood lead, equal to or greater than 80 percent; (vi) Chemistry, equal to or greater than 80 percent; (vii) Coagulation, equal to or greater than 80 percent; (viii) Cytogenetics, as set by PT program; (ix) Drugs of abuse, forensic, equal to or greater than 90 percent; (x) Drugs of abuse, clinical or diagnostic, equal to or greater than 80 percent; (xi) Hematology, equal to or greater than 80 percent; (xii) Immunohematology, ABO and Rh typing, antibody screen, 100 percent; (xiii) Immunohematology, antibody identification, equal to or greater than 90 percent; (xiv) Mycology, equal to or greater than 80 percent; (xv) Mycobacteriology, equal to or greater than 80 percent; (xvi) Immunology, nonsyphilis serology, equal to or greater than 80 percent; (xvii) Parasitology, equal to or greater than 80 percent; (xviii) Syphilis serology, equal to or greater than 80 percent; and (xix) Urinalysis, equal to or greater than 80 percent. (c) Scoring Criteria. A percent score is derived by dividing the number of satisfactory PT results by the total number of PT results for each subdiscipline, specialty, subspecialty, or individual constituent or analyte within a subspecialty. (d) PT Failure. PT scores lower than the percent scores listed in §C(2)(b) of this regulation are failing scores. (e) Evaluated PT Results. PT results evaluated in determining PT performance include PT results not evaluated by the PT program, code 10 results, for example, 10E, 10G, 10T, and codes of tests not performed. (3) Initial or Single PT Failure. (a) Licensee Action. A licensee shall investigate a single or initial PT failure and document the corrective action taken. (b) Departmental Procedures. The OHCQ shall document an initial or single PT failure and may request a licensee to submit a plan of correction and supporting documentation related to the failure. (4) Marginal PT Performance. (a) Test Scores. PT performance is marginal when a laboratory exhibits failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol. (b) Departmental Procedures. The OHCQ shall: (i) Document the marginal PT; (ii) Send written notice of the marginal PT to the licensee; and (iii) Request the licensee to submit a written plan of correction. (c) Laboratory Actions. A licensee shall submit to the OHCQ a written plan of correction that describes the investigation and steps taken to improve the applicable test performance. (5) Unsatisfactory PT Performance. PT performance is unsatisfactory when a laboratory exhibits: (a) Failing PT scores in three of four consecutive testing events in a subdiscipline, specialty, or individual constituent or analyte, for example, Na, RBC, cholesterol; (b) Failing PT scores in two of three consecutive testing events in a subdiscipline, specialty, subspecialty, or individual constituent or analyte, for example, Na, RBC, cholesterol, and the next PT report for the test states “test not performed”; or (c) An average PT score for a test over the last four consecutive testing events that falls below the minimum percent score set forth in §C(2)(b) of this regulation. #### Regulation .02 Discipline, Specialty, and Subspecialty. *COMAR 10.10.05.02* A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory participates successfully in PT, when applicable, for each test or analyte in each of the following disciplines, subdisciplines, and specialties: (1) Microbiology, including the subdisciplines of: (a) Bacteriology; (b) Mycobacteriology; (c) Mycology; (d) Parasitology; and (e) Virology; (2) Immunology, including the subdisciplines of: (a) General immunology; (b) General serology; and (c) Syphilis serology; (3) Chemistry, including the subdisciplines of: (a) Blood gas analysis; (b) Endocrinology; (c) Routine chemistry; and (d) Toxicology; (4) Genetics, including the subdisciplines of: (a) Biochemical genetics; (b) Cytogenetics; and (c) Molecular genetics; (5) Hematology, including the subdisciplines of: (a) Coagulation testing; and (b) Routine hematology; (6) Pathology, including the subdiscipline of gynecologic cytology; (7) Immunohematology, including the specialties of: (a) ABO group and D(Rho) typing; (b) Unexpected antibody detection, that is, antibody screen; (c) Antibody identification; and (d) Compatibility testing; and (8) Forensic toxicology limited to job-related alcohol and controlled dangerous substances. B. Discipline Standards. (1) General. A licensee operating under a permit shall ensure that the laboratory meets the applicable PT standards set forth in this chapter and in 42 CFR §§493.821493.865. (2) Gynecologic Cytology. A licensee operating under a permit to perform gynecologic cytology shall ensure that the laboratory enrolls and maintains successful participation in a cytology PT program approved by CMS. (3) Job-Related Testing. (a) A licensee operating under a permit to perform job-related testing for alcohol or controlled dangerous substances shall ensure that the laboratory enrolls and continues to participate satisfactorily, when applicable, in one or more of the programs listed in §B(3)(b)(e) of this regulation. (b) Screening Tests. A licensee operating under a permit to perform screening tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The American Association of Bioanalysts (AAB) Urine Toxicology Screening survey; (ii) The American Association for Clinical Chemistry/College of American Pathologists (AACC/CAP) Forensic Urine Drug Testing Screening survey; or (iii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter. (c) Confirmation Tests. A licensee operating under a permit to perform confirmation tests for job-related alcohol and controlled dangerous substances shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The AACC/CAP Forensic Urine Drug Testing Confirmatory survey; (ii) The federal Substance Abuse and Mental Health Services Administration's Federal Workplace Drug Testing Program; or (iii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter. (d) Blood Alcohol Tests. A licensee operating under a permit to perform tests for alcohol in blood shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The AACC/CAP survey for whole blood alcohol or serum alcohol, or both; or (ii) Another program approved by the Secretary as set forth in Regulation .03 of this chapter. (e) Hair Analysis. A licensee operating under a permit to perform tests for a controlled dangerous substance in hair shall ensure that the laboratory enrolls and participates satisfactorily in: (i) The State of Florida's P.T. program for drug testing in hair; or (ii) Another program that possesses standards set by the Secretary or that are equivalent to the State of Florida's PT program for drug testing in hair and is approved by the Secretary as set forth in Regulation .03 of this chapter. #### Regulation .03 Program Approval. *COMAR 10.10.05.03* A. Approval Required. A private, nonprofit, or commercial organization or government agency may not provide a PT program in this State without first obtaining program approval from CMS or the OHCQ. B. Approval Granted Automatically. Except in the discipline of job-related alcohol and controlled dangerous substances, or other disciplines, subdisciplines, or specialties not covered by federal PT requirements, a PT program is approved when it is based on written evidence issued by CMS showing the program meets CMS's criteria for approval of PT programs as set forth in 42 CFR §§493.901—493.959. C. Approval Granted by the Secretary. The OHCQ may approve a PT program for a laboratory discipline, subdiscipline, or specialty not approved by CMS, if the program: (1) Provides reliable, documented evidence that the program is technically and administratively able to meet the applicable requirements of this chapter; and (2) Uniformly and routinely prepares and submits directly to the OHCQ evaluations of all PT results from all laboratories enrolled in the program and holding a Maryland permit. #### Regulation .04 Cytology — Departmental Requirements. *COMAR 10.10.05.04* A. The Secretary may not issue a license to operate a laboratory that examines gynecologic cytology specimens if the laboratory does not enroll and participate satisfactorily in a cytology PT program approved by CMS. B. The OHCQ shall evaluate an individual's PT performance as set forth in 42 CFR §493.945. #### Regulation .05 Cytology — Laboratory and Individual Standards. *COMAR 10.10.05.05* A. Primary Standard. A pathologist or cytotechnologist who examines gynecological cytology specimens from individuals in this State shall participate satisfactorily in an annual cytology PT program approved by CMS. B. Laboratory Standards. (1) A licensee operating under a permit to examine gynecologic cytology specimens shall ensure that each pathologist and cytotechnologist who examines gynecologic cytology specimens participates in a cytology PT program conducted by the Department or approved by CMS. (2) A licensee employing an individual who has failed a second testing event in an annual PT cycle shall: (a) Prohibit the individual from examining gynecologic specimens and provide or secure remedial training and education in gynecologic cytology for the individual, which training and education includes examination by the individual of gynecologic specimens in the individual's area of failure; and (b) Document the individual's completion of education and training. (3) A licensee employing an individual who has failed a first or subsequent PT event and who does not obtain mandated retesting or retraining, or both, shall: (a) Immediately remove that individual from a position of examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider; and (b) Provide written notice to the OHCQ within 30 days after being informed of the individual's last test failure that the individual is no longer examining gynecologic cytology specimens for the purpose of reporting diagnostic test results to a health care provider. C. Individual Standards. (1) A cytotechnologist or pathologist who examines gynecological cytology specimens shall participate in an annual PT event that involves the examination of a 10-slide or 20-slide test set as set forth in 42 CFR §493.945. (2) An individual passes a testing event and performs satisfactorily in PT when the individual scores at least 90 percent on a 10-slide or 20-slide test set. (3) An individual fails a testing event and performs unsatisfactorily in PT if the individual: (a) Scores less than 90 percent on a 10-slide or 20-slide test set; or (b) Fails to take a scheduled retest without prior Department approval. (4) An individual who fails the annual testing event shall take a second test with another 10-slide test set: (a) Within 45 days after receiving notice of a test failure; or (b) At a later date with prior Department approval. (5) An individual who fails a second test shall: (a) Cease examining gynecologic specimens immediately upon being notified of the second failure; (b) Complete at least 40 hours of remedial training and education in gynecologic cytology that includes examining gynecological specimens in the area of failure; (c) Complete the required training and education in a laboratory that operates under a: (i) State permit for in-State laboratories; or (ii) Certificate issued by CMS in the subdiscipline of gynecologic cytology for out-of-State laboratories; (d) Document the required remedial training and education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ; (e) Schedule and take a third test with a 20-slide test set within 30 days of completing the required remedial training and education; and (f) Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the third test. (6) An individual who fails a third or subsequent test shall: (a) Complete at least 35 hours of documented, formally structured, continuing education in diagnostic cytopathology that focuses on the examination of gynecologic preparations; (b) Document the education when completed, using a form provided by the OHCQ, and submit the completed form to the OHCQ; (c) Schedule and take a subsequent test with a 20-slide test set within 30 days of completing the required continuing education; and (d) Begin examining gynecologic cytology specimens only after the OHCQ informs the individual that the individual obtained a passing score on the test required under §C(6)(c) of this regulation. (7) An individual who fails a first or subsequent testing event in an annual PT cycle and who chooses not to complete mandatory retesting or remedial training, or both, shall: (a) Immediately cease examining gynecologic cytology specimens and notify the OHCQ of this in writing; and (b) Reenter the PT process at the point where the individual previously chose to withdraw from the testing process, if the individual decides at a later date to satisfy PT requirements. ### Chapter 06 — Medical Laboratories — Quality Assurance **Authority:** Health-General Article, §§17-202, 17-202.1, 17-214, and 17-504, Annotated Code of Maryland **Administrative History:** Effective date: November 18, 1985 (12:23 Md. R. 2217) **Administrative History:** Regulations .01—.06, Physicians' Group Practice Laboratories in Maryland, repealed effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulations .01—.28, Physician Office and Other Point-of-Care Laboratories, adopted effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulation .03B amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .08C amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .09B amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Regulation .25 amended effective September 16, 1991 (18:18 Md. R. 2005) **Administrative History:** Chapter, Physician Office and Other Point-of-Care Laboratories, repealed and new chapter, Medical Laboratories—Quality Assurance, adopted effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02A amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .02B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .02C amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .03B amended effective July 24, 2000 (27:14 Md. R. 1340); January 13, 2011 (38:1 Md. R. 11) **Administrative History:** Regulation .04B adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .04B amended effective April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .05 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05-1 adopted effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .06 repealed effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .07B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .08 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .08B amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .09 repealed effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .10 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .10B amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .12 amended effective July 22, 2002 (29:14 Md. R. 1074); April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .12B amended effective April 16, 2012 (39:7 Md. R. 492); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .13B amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .14B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .15 amended effective June 1, 2009 (36:11 Md. R. 787); April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .15B amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .16 repealed effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .16A amended effective June 1, 2009 (36:11 Md. R. 787) #### Regulation .01 General. *COMAR 10.10.06.01* A. Primary Standards. To obtain or maintain a permit to operate a laboratory, a person or licensee shall ensure that the laboratory: (1) Establishes and follows written policies and procedures for a comprehensive quality assurance program designed to monitor and evaluate the ongoing and overall quality and safety of the total, that is, preanalytic, analytic, and postanalytic phases of the testing process; (2) Maintains a quality assurance program that: (a) Continually evaluates the effectiveness of the laboratory's policies and procedures; (b) Routinely revises policies and procedures based on the results of on-going evaluation; (c) Identifies and corrects problems; (d) Assures accurate, reliable, and prompt reporting of test results; (e) Assures adequate and competent personnel; and (f) Documents all quality assurance activities; and (3) Establishes and maintains a laboratory safety program. B. Standards. A licensee shall ensure that the laboratory: (1) Meets the applicable: (a) Quality assurance standards set forth in this chapter and in 42 CFR §§493.1230 — 493.1299; and (b) Quality testing standards for facility administration set forth in this chapter and in 42 CFR §§493.1100 — 493.1101; (2) Establishes, maintains, and enforces a laboratory safety program that: (a) Provides all personnel with access to a safety manual covering the following topics, when applicable: (i) General personnel safety; (ii) Fire prevention and control; (iii) Biological hazards; (iv) Chemical hazards; (v) Radiological hazards; (vi) Special medical waste disposal; and (vii) The reporting of incidents and accidents; and (b) Complies with the following applicable federal Occupational Safety and Health Administration standards: (i) “Occupational Exposure to Hazardous Chemicals in Laboratories”, contained in 29 CFR §1910.1450; and (ii) “Bloodborne Pathogens,” contained in 29 CFR §1910.1030; and (3) Maintains a collection station: (a) As part of and under the direction of the laboratory for which it collects specimens; and (b) With equipment and staff appropriate for the collection, preservation, storage, and maintenance of specimens in a manner suitable for later examination. #### Regulation .02 Authorization to Request Laboratory Tests. *COMAR 10.10.06.02* A. Primary Standard. A laboratory may not perform a laboratory test, except under a health awareness permit or cholesterol permit, without obtaining written or electronic authorization from: (1) A court of law; (2) A doctor of medicine, osteopathy, podiatric medicine, or dentistry; or (3) Another person authorized to order laboratory tests under the Annotated Code of Maryland. B. Other Authorized Persons. Other persons authorized to order laboratory tests include: (1) A nurse midwife certified by the Maryland State Board of Nursing under COMAR 10.27.05; (2) A nurse practitioner certified by the Maryland State Board of Nursing under COMAR 10.27.07; (3) A physician's assistant, as authorized by the physician's assistant's supervising physician; (4) A chiropractor requesting a test on blood or urine; (5) An employer requesting a job-related test for alcohol or controlled dangerous substances; (6) Clinical staff who: (a) Meets the qualifications set forth in COMAR 10.47.01.06D; (b) Is employed by a substance abuse treatment program that is certified or accredited in accordance with COMAR 10.47.04.03; and (c) Is authorized to order tests to detect the presence of controlled dangerous substances on patients enrolled in the substance abuse treatment program; (7) A pharmacist, for tests that qualify for a letter of exception under COMAR 10.10.03.02B and for glucose, A1c, lipids (including total cholesterol, HDL, LDL, and triglycerides), AST, and ALT; and (8) A naturopathic physician consistent with Health Occupations Article, §14–5F–01 through §14–5F–32, Annotated Code of Maryland and COMAR 10.32.21. C. Standards. A licensee shall ensure that the laboratory meets the applicable standards concerning test requisition contained in 42 CFR §493.1241. #### Regulation .03 Patient Test Management. *COMAR 10.10.06.03* A. Primary Standard. A licensee shall ensure that the laboratory: (1) Provides patient manipulation by qualified personnel; and (2) Employs and maintains a quality assurance program that provides for: (a) Proper patient preparation; (b) Proper specimen: (i) Collection; (ii) Identification; (iii) Preservation; (iv) Transportation; and (v) Processing; (c) Record maintenance; and (d) Accurate reporting of results. B. Standard — Patient Manipulation and Specimen Collection. (1) A person may not manipulate a patient, for example, to collect specimens unless the person is: (a) A licensed: (i) Physician; or (ii) Nurse; (b) Authorized by law to: (i) Collect a specimen from an individual for medical laboratory testing; or (ii) Manipulate a patient; or (c) Employed by a licensee under this title. (2) A licensee shall ensure that specimens for laboratory testing are collected by individuals who are trained in and have documented experience in: (a) Preparing patients for specimen collection; and (b) Collecting the appropriate specimen required for the requested test. (3) Qualified personnel authorized by the licensee may collect: (a) Blood specimens, including: (i) Venipuncture; and (ii) Finger or heel stick whole-blood specimens; (b) Stomach contents; and (c) Clinical materials for smears and culture, for example, throat and nasopharyngeal swabs, and other specimens required to perform a requested test under the direction or on the written request of a physician or other person authorized by law and identified in Regulation .02 of this chapter. (4) An employer may collect a specimen for job-related testing to determine use or abuse of a controlled dangerous substance or alcohol as set forth under COMAR 10.10.10. (5) A person collecting specimens for medical laboratory testing or examination shall follow the licensee's policies and procedures contained in the laboratory's quality assurance system as set forth in §C of this regulation. (6) This section does not apply to the collection of a DNA specimen with a buccal swab used for determining paternity. C. Standard — Quality Assurance. A licensee shall ensure that the laboratory's quality assurance system: (1) Provides optimum patient test results by establishing and maintaining mechanisms to preserve specimen integrity and maintain positive specimen identification throughout the entire testing process, including the: (a) Preanalytic phase; (b) Analytic phase; and (c) Postanalytic phase; and (2) Meets the applicable standards contained in 42 CFR §§493.1230 — 493.1234, 493.1240 — 493.1249, and 493.1281—493.1299. #### Regulation .04 Reporting and Releasing Test Results. *COMAR 10.10.06.04* A. Primary Standard. A laboratory shall report or release test results, except results of a health awareness test, only to an authorized person. B. Standards. (1) For all test results except those from a health awareness test performed at a temporary laboratory or from a job-related alcohol or controlled dangerous substance test, a licensee shall ensure that the laboratory: (a) Reports medical test results only to the physician, dentist, or other authorized person who requested the test, or to another laboratory that requested the test; (b) Sends a copy of a test result, other than a result for a health awareness or job-related alcohol or controlled dangerous substances test, directly to the individual tested only after the laboratory: (i) Receives a written request from the individual; and (ii) Notifies the authorized person who requested the test that the results will be released to the individual tested; (c) Meets the applicable standards concerning test reports contained in 42 CFR §§493.1234 and 493.1291; and (d) Reports a test result on a form that identifies the name and address of the laboratory that performed the test. (2) For test results stemming from a health awareness test, set forth in COMAR 10.10.01.03B, and performed at a temporary laboratory, the laboratory may report those results directly to the individual tested. (3) If the results of the tests listed in Regulation .02B(7) of this chapter are not within the desired range, the pharmacist shall provide: (a) The test results to the patient’s primary care practitioner for evaluation and treatment; or (b) The patient with a referral to a licensed independent practitioner for evaluation and treatment. #### Regulation .05 Quality Control — General. *COMAR 10.10.06.05* A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written quality control procedures for monitoring and evaluating the quality of the analytic phase of the testing process for each testing method and procedure to assure the accuracy and reliability of patient test results and reports. B. Standard. A licensee shall ensure that the laboratory meets the applicable quality control standards as set forth in this chapter and in 42 CFR §§493.1200—493.1299. #### Regulation .05-1 Quality Control — Quality Control Program. *COMAR 10.10.06.05-1* A. Primary Standard. A licensee shall develop, establish, implement, maintain, and follow quality control policies, procedures, and techniques that ensure accurate and reliable test results and patient test reports. B. Standard — Quality Control Program. A licensee's quality control program shall: (1) Cover all tests and related examinations and procedures performed by the laboratory; and (2) Meet the standards and requirements set forth in this chapter. C. Standard — Quality Control Practices. A licensee's quality control practices shall include, but are not limited to, the use of: (1) Analyses of reference materials to ensure that test results are: (a) Reproducible; (b) Accurate; and (c) Reliable; (2) Systems to ensure proper functioning of: (a) Instruments; (b) Equipment; and (c) Reagents; (3) Validity, calibration, and systematic procedural checks for: (a) Reagents; (b) Equipment; and (c) Test systems; and (4) Systems for: (a) Review and reporting of test results that ensure timely error detection and correction; and (b) Assessment of laboratory personnel: (i) Performance; (ii) Proficiency; and (iii) Competency. D. Standard — Adequacy of Methods and Equipment. A licensee shall: (1) Employ methods and equipment that provide accurate and reliable test results and reports; (2) Have sufficient and suitable equipment and instruments to perform the type of testing services and volume of tests offered by the laboratory; (3) Monitor all test methods, instruments, and test systems for the following performance characteristics, when applicable: (a) Detection limits for each: (i) Method; (ii) Instrument; and (iii) Test system; (b) Precision; (c) Accuracy; (d) Specificity; (e) Sensitivity; (f) Test interferences; and (g) Other related test variables that affect test results; (4) Have adequate systems in place to: (a) Ensure that a statistically valid number of counts or measurement levels are obtained and verified to give accurate and reliable test results for systems each day instruments and equipment such as cell counters, radiation counters, and spectrophotometers are used; and (b) Report results in an accurate and reliable manner and within the time frames established by the laboratory; and (5) Perform test methods and use instrumentation in a manner that permits the laboratory to provide accurate and reliable test results within the laboratory's stated performance criteria. E. Standard — Supplies, Reagents, and Materials. A licensee shall ensure that supplies, reagents, and other materials used in the collection, handling, testing, and storing of specimens in the laboratory are stored, labeled, checked for proper reactivity, and used according to §§F — I of this regulation. F. Storage. A licensee shall ensure that laboratory materials are stored in the manner stated by the manufacturer. G. Labeling. A licensee shall ensure that laboratory testing materials, including reagents, solutions, culture media, controls, and calibrators are labeled to indicate the: (1) Identity; (2) Concentration, strength, or titer; (3) Storage requirements; (4) Preparation and expiration dates; (5) Identity of the preparer; and (6) Other pertinent information that would affect test performance or outcome. H. Reactivity Checks. A licensee shall ensure that representative samples of each lot of materials used for or in the process of testing specimens are tested on a regularly scheduled basis to determine each material's capacity to perform as required. I. Use of Supplies and Other Materials. A licensee: (1) May not use materials that have: (a) Exceeded the material's expiration date; (b) Substandard reactivity; or (c) Deteriorated; and (2) Shall use supplies, reagents, kits, identification systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer. #### Regulation .06 Quality Control — Single-Use Test Devices. — Repealed. *COMAR 10.10.06.06* #### Regulation .07 Quality Control — Specialty and Subspecialty. *COMAR 10.10.06.07* A. Primary Standard. A licensee operating under a permit shall ensure that the laboratory establishes and follows written policies and procedures for a comprehensive quality control program that includes verification and assessment of accuracy, measurement of precision, and detection of error for all analyses and procedures performed by the laboratory. B. Standards. (1) General. A licensee shall ensure that the laboratory meets the applicable quality control requirements for each specialty and subspecialty under: (a) 42 CFR §§493.1200—493.1299; and (b) Regulations .07—.15 of this chapter. (2) Cholesterol. A licensee or approved plan holder of a laboratory that performs cholesterol tests shall ensure that the laboratory obtains and maintains control samples at two levels, near or bracketing the 200 and 240 micrograms/deciliter decision levels. #### Regulation .08 Quality Control — Job-Related Alcohol and Drug Testing. *COMAR 10.10.06.08* A. Primary Standard. A licensee shall ensure that a laboratory has in place a quality assurance program designed to monitor and evaluate all phases of the testing process including but not limited to: (1) Laboratory certification; (2) Specimens, specimen collection, chain of custody, and transport; (3) Security and controlled access; (4) Storage and specimen retention; (5) Analytical methods and procedures; (6) Accuracy, precision, and reliability; (7) Reporting test results; and (8) Proficiency testing. B. Standards. (1) Certification. A licensee of a laboratory that offers to perform or performs screening or confirmation tests for alcohol or controlled dangerous substances shall ensure that the laboratory is inspected and certified to perform tests for alcohol or controlled dangerous substances by: (a) The Secretary; (b) The College of American Pathologists; (c) The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or (d) A government agency, program, or accrediting organization approved by the Secretary as set forth in COMAR 10.10.02.02. (2) Specimens, Specimen Collection, Chain of Custody, and Transport. (a) Permissible Specimens. A licensee shall ensure that job-related tests for alcohol or controlled dangerous substances are only performed using specimens derived from the human body as set forth in COMAR 10.10.10.06. (b) A licensee shall ensure that a specimen is processed, handled, and transported in a manner that protects the identity and physical integrity of the specimen by: (i) Accepting a specimen in a sealed container that has a non-resealable closure or an evidentiary tape that assures detection of any tampering; and (ii) Implementing, maintaining, and employing chain of custody procedures, including documentation of specimen handling and access, that cover the life of a specimen from the time of collection through final disposal of the specimen. (c) Decontamination Requirement for Hair Specimens. A licensee shall ensure that the laboratory establishes, validates, and uses a procedure to remove possible external contamination from a hair specimen before a test is performed. (3) Security and Controlled Access. A licensee shall ensure that a specimen is collected and processed in a manner that protects the physical integrity of the specimen by: (a) Collecting and processing a specimen under supervised conditions; (b) Securing the laboratory or any portion of the laboratory used for job-related alcohol or controlled dangerous substances testing; (c) Using and maintaining secure specimen storage areas that include, when applicable, locked freezers and refrigerators; (d) Limiting access to testing and specimen storage facilities to authorized personnel; (e) Exercising and maintaining control over a specimen storage area by documenting in an access log the identity, date, time of entry and exit, and the purpose for entry for each individual who enters the storage area; and (f) Recording, reporting, and maintaining a test result in a manner that prevents alteration and breech of confidentiality by: (i) Limiting access to a test result to authorized personnel; and (ii) Preparing and storing a test result in a secured area. (4) Storage and Specimen Retention. A licensee shall ensure that a: (a) Positive urine or hair specimen is retained in the original collection container for at least 6 months after a final test result is reported; (b) Positive urine or blood specimen is stored at less than or equal to -20° Centigrade; and (c) Negative specimen is retained for at least 5 days at less than or equal to room temperature. (5) Analytical Methods and Procedures. A licensee shall ensure that tests are performed using proven and reliable methods and procedures that are approved by the: (a) Secretary; (b) College of American Pathologists (CAP); (c) The federal Substance Abuse and Mental Health Services Administration (SAMHSA); or (d) United States Food and Drug Administration (FDA). (6) Approval of Methods and Procedures. The Secretary shall base approval or acceptability of any analytical method or procedure with questioned validity or reliability on evidence published in a peer-reviewed scientific journal and derived from independent: (a) Scientific testing and evaluation; or (b) Scientifically based clinical trial. (7) Accuracy, Precision, and Reliability. The licensee shall ensure that the laboratory employs quality control mechanisms and practices, including but not limited to those assuring accuracy, precision, and reliability of test results by: (a) Using a sufficient number of reference standard samples with each batch of test specimens to ensure accuracy of the assay or procedure's linearity over time; (b) Using reference standard samples that have values at or near the minimum drug detection levels or concentrations; (c) Using results obtained from testing reference standard samples to document linearity and calculate test data obtained from test specimens; (d) Including in each analytical run quality control samples that are: (i) Certified to contain no alcohol or controlled dangerous substance; (ii) Fortified with known reference standards; (iii) Positive with the alcohol or controlled dangerous substance at or near the cutoff or minimum detection level; and (iv) Using a total number of quality control samples in an analytical run equal to at least 5 percent of the number of specimens being tested; (e) Verifying and documenting at least monthly the linearity and precision of each test method and procedure; and (f) Using methods, procedures, and techniques that prevent samples and specimens from contaminating one another throughout the testing process. (8) Cutoff Levels. (a) A licensee that offers to perform or performs job-related alcohol or controlled dangerous substances testing shall use the established cutoff levels specified in §B(8)(b) and (c) of this regulation to distinguish a positive from a negative test specimen. (b) Urine. A laboratory testing urine shall use the cutoff levels set forth in 49 CFR §40.85. (c) Blood, Saliva, and Hair. (i) A licensee testing blood, saliva, or hair specimens shall use the cutoff levels established by an agency of the federal government for the purpose of determining whether a specimen is positive or negative for alcohol or a controlled dangerous substance. (ii) If cutoff levels in blood, saliva, or hair have not been established and accepted by an agency of the federal government, a licensee shall establish and use a cutoff level for each screening test and confirmatory test performed to determine whether a specimen is negative for each controlled dangerous substance that the licensee offers to detect by a screening or confirmatory procedure. (d) Validation. A licensee shall ensure that the: (i) Laboratory maintains documented data validating each cutoff level; and (ii) Cutoff data is made available for review by the OHCQ. (9) Reporting Test Results. A licensee shall ensure that a job-related laboratory test report includes: (a) A list of all the drug and alcohol tests that were performed on the specimen; (b) Positive test results only if the specimen was found positive by a confirmation test that employed a combination of: (i) Gas chromatography and mass spectrometry (GC/MS); (ii) Mass spectrometry and mass spectrometry (MS/MS); (iii) Gas chromatography tandem mass spectrometry (GC/MS/MS); or (iv) Other analytical methods that use mass spectrometry as the primary detection technique; (c) The value at the cutoff or detection level of each test, that is, screening test or confirmation test, or both, for alcohol or a controlled dangerous substance performed on the specimen; (d) The telephone number of the laboratory that may be used by an employer or individual who was tested to obtain technical assistance for the purpose of interpreting a positive test result; and (e) Except as provided in Health-General Article, §17-214(i), Annotated Code of Maryland, no information to an employer or prospective employer on: (i) The use of a nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or (ii) The use of a legally prescribed drug, unless the individual tested is unable to establish that the drug was prescribed in accordance with the laws of the State. (10) Proficiency Testing. A licensee shall ensure that the laboratory enrolls and continues to participate satisfactorily in a proficiency testing program that: (a) Covers each type of job-related alcohol and controlled dangerous substance test specimen analyzed; and (b) Has the approval of the Secretary as set forth in COMAR 10.10.05.03 of this subtitle. #### Regulation .09 Repealed. *COMAR 10.10.06.09* #### Regulation .10 Quality Control — Cytology. *COMAR 10.10.06.10* A. Primary Standard. A licensee of a laboratory offering to perform or performing tests in the subdiscipline of gynecologic cytology shall ensure that the laboratory: (1) Limits the number of slides an individual may examine as set forth in 42 CFR §493.1274; (2) Limits slide examination to the laboratory premises; (3) Establishes a quality assurance program and follows written quality control procedures to monitor and evaluate the quality of cytological procedures and testing processes; (4) Does not pay for the examination of cytology slides on a piecework basis; (5) Reviews not less than 10 percent of all negative gynecologic slides before reporting results on those slides; (6) Employs an individual who qualifies as a supervisory cytotechnologist or a technical supervisor in gynecologic cytology to review negative gynecologic slides; (7) Does not allow the evaluation of a slide that shows evidence of unsatisfactory preparation; (8) Reports as to whether a slide is satisfactory or unsatisfactory for evaluation; (9) Maintains records for 5 years of slides reported as unsatisfactory; (10) Maintains and stores for 5 years from the date of examination any slide that was examined; (11) Retains cytology reports for at least 10 years; (12) Does not send gynecologic cytology slides to a laboratory not holding a State license; and (13) Requires cytotechnologists and pathologists to obtain continuing education. B. Standards. (1) General. A licensee shall ensure that the laboratory complies with the applicable requirements in 42 CFR §493.1221. (2) Continuing Education. (a) A cytotechnologist or pathologist who is employed by a laboratory and who performs primary gynecologic screening shall obtain at least 20 credit hours per calendar year of continuing education in cytology. A credit hour is 1 hour of active participation in the educational activity. (b) An individual may obtain cytological continuing education in a formal or informal educational activity, such as reading journal articles, reviewing case histories, and attending lectures or workshops. This activity provides the individual with increased medical or technical knowledge of cytopathology or exfoliative cytology. (c) A licensee shall ensure that the laboratory annually compiles records of the continuing education for each cytotechnologist and pathologist and retains them for at least 2 years. #### Regulation .11 Quality Control — Dermatopathology. *COMAR 10.10.06.11* A. Primary Standard. In addition to meeting the requirements of other applicable regulations of this subtitle, a licensee of a laboratory performing tests in the subdiscipline of dermatopathology shall ensure that the laboratory: (1) Retains the services of either a: (a) Laboratory director who meets the qualifications in COMAR 10.10.07.04B(1); or (b) Technical supervisor who meets the qualifications in COMAR 10.10.07.05B(4); (2) Maintains applicable records and reports; and (3) Effectively processes and stores specimens, slides, and tissue. B. Standards. (1) Maintenance of Records, Reports, Tissue, and Slides. (a) A licensee shall ensure that the laboratory maintains a system of documentation to monitor the collection, receipt, handling, transport, processing, testing, and reporting of all specimens. (b) A system of documentation may include: (i) A laboratory specimen log book; or (ii) Accession sheets or records. (c) A licensee shall ensure that the laboratory generates a written report for each patient specimen that is examined either microscopically or macroscopically. The report shall include: (i) Patient name, age, and sex; (ii) The dates of specimen collection and processing; (iii) The source or anatomic site of a specimen; (iv) A gross description of the specimen; (v) A description of the tissue, for example, bisected, submitted in total, number of blocks, or that only representative sections were submitted; (vi) The diagnosis or observed results of the test or examination; (vii) The examining physician's name, signature, and date of report; (viii) If appropriate, the clinical impression or differential diagnosis; and (ix) Other pertinent or essential patient history that may affect the accuracy or reliability of the report. (d) A licensee shall ensure that a laboratory retains: (i) Records and reports for at least 10 years for final reports and 2 years for other laboratory records; (ii) Wet tissue or tissue remnants for 2 weeks after a final report is issued; (iii) A specimen or tissue in a paraffin block for 5 years from the date of examination; and (iv) Slides for 10 years from the date of examination. (e) A licensee shall ensure that specimens, slides, and tissues are: (i) Processed in a facility licensed under this chapter; (ii) Appropriately fixed for the tests performed; (iii) Properly labeled with at least the patient's name or other cross-referenced identifier, such as a case or accession number; and (iv) Adequately stored and effectively filed to allow easy access and retrieval. (2) Quality Control. When a slide or specimen is processed or stained in the laboratory, the licensee shall ensure that: (a) A staining container is labeled and covered when not in use; (b) A stain and a working solution are changed at appropriate intervals; and (c) Routine employee access is provided to flowcharts and other written procedures that accurately reflect the procedures in use. #### Regulation .12 Quality Control — Temporary and Mobile Laboratories: General. *COMAR 10.10.06.12* A. Primary Standard. The licensee shall ensure that a health awareness test or a job-related screening test for alcohol or controlled dangerous substances at a temporary or mobile laboratory is performed: (1) Under effective supervision, quality control, and safety procedures; (2) Using a previously evaluated analytical system; and (3) For a job-related screening test for alcohol or controlled dangerous substances, only at the request of an individual authorized in COMAR 10.10.06.02. B. Standards. (1) Limited Tests. A person may perform at a temporary or mobile laboratory only the health awareness tests defined in COMAR 10.10.01.03B and job-related screening tests for alcohol or controlled dangerous substances. (2) Health awareness and cholesterol testing may be performed at the request of the examinee. Staff who perform the tests shall have training and experience to perform testing that includes: (a) Operation of the analyzers per manufacturer’s recommendations; (b) Evaluation of the results of the quality controls; (c) Interpretation of the test results; and (d) Counseling to the individual whose specimen is tested. (3) Supervision. A designated supervisor, knowledgeable in all aspects of the health awareness testing, shall be present at a temporary or mobile laboratory throughout a testing event to oversee testing, including compliance with all applicable requirements set forth in this chapter. (4) Testing Sites. (a) A person may not perform a health awareness test in a restaurant where food or drink is prepared, served, or consumed. (b) A licensee shall ensure that a temporary laboratory: (i) Provides space, when applicable, for counseling examinees regarding test results; (ii) Provides space appropriate for the number of staff, analytical systems, and examinees; (iii) Provides work space adequate to minimize problems of transportation, communication, and safety; (iv) Provides electricity of the type and in the amount needed to operate analytical systems properly; (v) Includes access to water and disinfectant supplies for routine cleaning and disinfection of the work area, equipment, and personnel; (vi) Contains or is within 1 minute of a telephone with access to emergency assistance by calling 911; (vii) Maintains levels of temperature, humidity, and ventilation to comply with manufacturer's specifications for effective operation of analytical systems; (viii) Is situated a minimum of 12 feet from any produce, meat, or dairy department in a food market; (ix) Maintains partitions, such as ropes, on at least three sides of an area where blood is drawn or processed, to prevent unsupervised access to a blood-drawing or testing area; (x) Employs separate receptacles for routine laboratory and special medical wastes within partitioned testing areas; (xi) Provides for the storage of reagents and other testing materials within temperatures recommended by the manufacturer; and (xii) Complies with all pertinent State laws and local ordinances. (5) Pre-Field Evaluation of Analytical Systems. A licensee may not employ an analytical system in a mobile or temporary laboratory until the laboratory has documented the analytical system's levels of accuracy and precision in a permanent laboratory facility. (6) In-Field Quality Control. A licensee operating a mobile or temporary laboratory shall establish and maintain a continuous quality control program for an analytical system operated in that mobile or temporary laboratory. (7) Phlebotomy Quality Control and Safety. (a) A licensee employing a phlebotomist at a temporary or mobile laboratory shall ensure that the phlebotomist is trained in proper techniques for: (i) Specimen collection; and (ii) Infection control. (b) A licensee shall provide appropriate protective clothing and disposable gloves and ensure that they are used appropriately by all personnel involved in drawing or handling blood. (c) A phlebotomist shall wear new gloves for each examinee. (d) A laboratory employee shall use and clean phlebotomy devices as prescribed by the manufacturer. (8) Testing Logs. A licensee shall maintain for 2 years a log identifying all: (a) Persons tested; (b) Test results; and (c) Test dates. (9) Results Reporting. The licensee of a temporary or mobile laboratory: (a) May give results of a health awareness test immediately following the testing directly to the individual who underwent the test; and (b) Shall give the test results in writing stating the: (i) Name of the individual tested, (ii) Name of the laboratory performing the test, (iii) Name of the test, (iv) Date of the test, and (v) Test result with appropriate interpretation or reference range consistent with current nationally recognized standards. (10) Disposal of Special Medical Waste. A licensee operating a temporary or mobile laboratory shall dispose of special medical waste as required in COMAR 10.06.06.01—10.06.06.07. #### Regulation .13 Quality Control — Temporary and Mobile Laboratories: Personnel Training. *COMAR 10.10.06.13* A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee shall ensure that all laboratory personnel performing a health awareness test at a temporary or mobile laboratory are trained to perform all assigned duties. B. Standards. (1) All Personnel. A licensee shall ensure that all personnel are trained to: (a) Keep examinees' health information confidential; (b) Deal with emergency situations such as fainting and anxiety reactions; (c) Report and document information on testing services and activities; and (d) Dispose of special medical waste as set forth in COMAR 10.06.06.01—10.06.06.07. (2) Phlebotomist. A licensee shall ensure that an individual who collects blood specimens is trained in: (a) Specimen collection methods; and (b) Infection control and prevention techniques, including CDC recommendations for preventing the transmission of bloodborne pathogens in health care settings. (3) Operator of an Analytical System: General. A licensee shall ensure that an operator of an analytical system is trained in: (a) Infection control and prevention techniques, including CDC recommendations concerning the transmission of bloodborne pathogens in health care settings; and (b) Proper use of the analytical system, including: (i) Analytical system operation; (ii) System methods used to process the specimen; and (iii) Quality control techniques, procedures, and requirements. (4) Operator of an Analytical System: Competency. (a) Obtaining Personal Competency. Before an individual may operate an analytical system without direct supervision, the individual operator shall demonstrate competency in operating the analytical system by completing: (i) Pre-field supervised practice that includes performing under direct supervision a minimum of ten tests of each applicable type of health awareness test; and (ii) Field testing experience that includes individual performance of directly supervised testing in the field. (b) Documenting Training and Competency. The licensee shall document in writing that each analytical system operator has demonstrated competency as required under this regulation. #### Regulation .14 Quality Control — Temporary and Mobile Laboratories: Event Registration. *COMAR 10.10.06.14* A. Primary Standard. In addition to meeting other applicable requirements set forth in this chapter, a licensee intending to perform a health awareness test at a temporary or mobile laboratory shall register the testing event with the Department before the testing event may occur. B. Standards. (1) A licensee shall inform the OHCQ by phone or in writing of the date, time, location, and on-site supervisor's name for a testing event at least 14 days before the event is to take place. (2) A licensee shall display in a public place at the testing site and throughout the testing event a copy of the laboratory's license. #### Regulation .15 Quality Control — Temporary and Mobile Laboratories: Cholesterol and Health Awareness. *COMAR 10.10.06.15* A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee offering to perform or performing cholesterol or health awareness testing at a temporary or mobile laboratory shall ensure that the laboratory: (1) Develops and maintains a written SOPM; (2) Validates the analyzer initially and utilizes the manufacturer’s reference range for the quality control with each new lot of quality control; (3) Employs and maintains an in-field quality control program; (4) Reports test results as set forth in §B(5) of this regulation; and (5) Informs examinees of test limitations based on current nationally recognized standards for each test performed. B. Standards. (1) Supervisor. A supervisor knowledgeable in all aspects of health awareness testing shall oversee all cholesterol or health awareness testing conducted at a temporary or mobile laboratory. (2) SOPM. (a) A licensee shall develop and maintain a written SOPM covering all current procedures for: (i) Training personnel; (ii) Analytical system maintenance; (iii) Testing participants and quality control; (iv) Retesting; (v) Documenting lot numbers and expiration dates of quality control materials and reagents (cassettes) used for participant testing; (vi) Evaluation of quality controls on site and documentation of corrective actions when quality control results are unacceptable; (vii) An every 6 month evaluation of all analyzers used in Maryland using the worksheet provided by the Department; and (viii) Other aspects of the cholesterol and health awareness testing service's activities. (b) The general supervisor or director shall initially approve and when changes are made review, sign, and date the SOPM. (c) All personnel shall have routine access to a copy of the SOPM at each testing site throughout each testing event. (3) Method Verification and Pre-Field Evaluation of an Analytical System. A licensee shall evaluate each analytical system by: (a) Performing a method verification to demonstrate that the system produces test results within limits of accuracy and precision, as defined by either the licensee or the system's manufacturer, before the system may be used at a temporary or mobile laboratory; and (b) Analyzing two levels of quality control materials. (4) In-field Quality Control. At a temporary or mobile laboratory, a licensee shall maintain a continuous quality control program in which: (a) Each person who performs tests at a screening event shall test both levels of quality control samples identified in §B(3)(b) of this regulation on one analyzer for each cholesterol and health awareness test performed at the screening event; (b) Quality control testing shall be performed on at least one analyzer, if more than one analyzer at a screening event is used; (c) Each testing person shall test two levels of quality control materials on another analyzer at the beginning of the cholesterol or health awareness event if more than one person is performing tests at an event; and (d) The laboratory shall complete the comparison worksheet designated by the Department quarterly to ensure that all the analyzers used for reporting test results produce results within 15 percent to 20 percent of the other analyzers. (5) Examinee results shall be reported above the established reportable range of the instrument, that is, analytic range, as greater than the highest reference point, with the analytic range being determined by pre-field testing. (6) Reporting and Releasing Test Results. (a) A licensee shall release cholesterol or health awareness test results only to the examinee or their physician in writing and in a manner to protect the confidentiality of the test results. (b) A licensee shall include the following on its reports: (i) The name, address, and phone number of the laboratory performing the test; (ii) The date and location of the testing; and (iii) The signature, initials, or electronic authentication of a laboratory employee. (c) A laboratory shall provide to an examinee a written explanation of all cholesterol and health awareness test results and refer the examinee for medical care when indicated by the results. ### Chapter 07 — Medical Laboratories — Personnel **Authority:** Health-General Article, §§17-202, 17-203, 17-206, Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01B amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05 amended effective July 24, 2000 (27:14 Md. R. 1340) **Administrative History:** Regulation .05B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .07B amended effective March 1, 2026 (52:24 Md. R. 1198) #### Regulation .01 Permitted POL and POCL — Director and Associate Director. *COMAR 10.10.07.01* A. Primary Standard. The licensee of a permitted POL or POCL shall employ or otherwise engage the services of a qualified director or associate director and a laboratory supervisor or consulting supervisor. B. Standards. (1) Qualifications. (a) POL. The director of a permitted POL shall be: (i) A physician licensed by the Board of Physicians to practice medicine in the State and a member or employee of the practice operating the laboratory; or (ii) An employee or contractor of the practice who possesses the training and experience set forth in Regulation .05 of this chapter. (b) POCL. The director of a permitted POCL shall be: (i) A physician of the medical care facility who possesses the applicable training and experience set forth in Regulation .05 of this chapter; (ii) An individual who qualifies as a director under 42 CFR §493.1443, and who possesses the applicable training and experience set forth in Regulation .05 of this chapter; or (iii) An individual who meets the definition of a technologist as set forth in COMAR 10.10.01.03B. (2) Duties and Responsibilities. (a) A director of a permitted POL or POCL shall participate in and actively oversee the planning, organization, direction, and review of all laboratory operations to the extent necessary to ensure compliance with this chapter. (b) A director's duties and responsibilities include: (i) When applicable, employing or otherwise engaging the services of a qualified general supervisor or consulting supervisor; (ii) Ensuring that the general supervisor or consulting supervisor spends sufficient time performing the supervisory duties and responsibilities; (iii) Completing and submitting to the OHCQ forms, supplied by the OHCQ, that document a general or consulting supervisor's education, training, and experience in laboratory practice; (iv) Recruiting qualified and competent technical personnel; (v) Obtaining or providing and documenting initial training and continuing education for technical personnel; (vi) Reviewing with the laboratory supervisor or consulting supervisor all laboratory procedures and policies and all evaluative material, including proficiency testing results, pertinent to the operation and performance of the laboratory; (vii) Serving as a liaison between the physicians of the practice or medical care facility and the laboratory supervisor or consulting supervisor and other technical personnel to communicate situations such as test interpretations, timeliness of reports, reporting abnormal test results, and new or changing laboratory procedures and policies affecting patient care; (viii) Ensuring that all application forms, documents, and other materials required under this chapter are submitted to the OHCQ within the appropriate time periods; and (ix) Designating an associate director, when applicable. (3) Associate Director. An associate director shall: (a) Meet the same qualifications as set forth in §B(1) of this regulation; and (b) Act as laboratory director when the laboratory director is away from the laboratory for a period of more than 30 days. (4) Supervisory Consultation. A director of a permitted POL or POCL shall: (a) Consult with the laboratory supervisor in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory; and (b) Conduct an on-site visit to each directed laboratory at least once a month. (5) Director Limitation. A POL director may not serve as director or associate director, or both, of more than five medical laboratories at the same time. (6) Changes in Employment or Service. A director shall notify the OHCQ within 30 days of any change in the director's service or employment as a laboratory director. (7) Director Disqualification. A director or associate director may be disqualified to direct a permitted POL for failing to comply with the applicable standards and requirements of this chapter. #### Regulation .02 Permitted POL and POCL — General Supervisor and Consulting Supervisor. *COMAR 10.10.07.02* A. Primary Standard. A licensee operating a POL or POCL under a permit shall employ or otherwise engage a qualified general supervisor or consulting supervisor. B. Standards. (1) Requirement. A laboratory shall employ or otherwise engage a qualified general supervisor or consulting supervisor who shall act in concert with the laboratory director to ensure that the laboratory complies with the standards and requirements of this chapter. (2) Qualifications — POL and POCL General Supervisor. To qualify as a laboratory supervisor in a permitted POL or POCL, an individual shall be a: (a) Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised; (b) Technologist as defined in COMAR 10.10.01.03B and employed to perform tests at least 1 day a week in the lab being supervised; or (c) Technician as defined in COMAR 10.10.01.03B and employed to perform tests on a full-time basis in the lab being supervised. (3) Qualifications — Consulting Supervisor. To qualify as a consulting supervisor of a POL or POCL, an individual shall be a: (a) Technologist as defined in COMAR 10.10.01.03B who possesses at least 2 years of work experience in a laboratory that: (i) Operated under a permit; and (ii) Performed testing services related to those offered by the laboratory to be supervised; or (b) Physician who is board certified, or eligible to be certified in clinical pathology, and employed to perform or oversee testing on a full-time or part-time basis in the laboratory being supervised. (4) Supervisory Duties and Responsibilities. A general supervisor or consulting supervisor shall: (a) Implement and maintain the applicable laboratory standards and requirements set forth in this chapter; (b) Ensure proper and reliable test performance, reporting, record keeping, and immediate general and technical supervision of testing personnel and laboratory services; (c) Develop, implement, and oversee maintenance of an internal quality assurance program that includes: (i) A working quality control program or system that determines and documents accuracy and precision of all tests performed; (ii) Selection and use of quality control and standard materials for analysis; (iii) Recording and documenting quality control data; (iv) Ongoing analysis of quality control data; and (v) Implementation and maintenance of a specimen documentation and management system; (d) Prepare and maintain a SOPM; (e) Ensure full participation in an external proficiency testing program approved by the Secretary as set forth in COMAR 10.10.05.03; (f) Teach proper laboratory techniques, including the importance of quality control, quality assurance, and proficiency testing; (g) Review proficiency testing results, determine sources of error, and work to correct any problems; (h) Review proficiency testing results, analytical studies and evaluations, and survey reports with technical personnel to improve test performance and laboratory services; (i) Maintain, as part of laboratory records, a log or other suitable record documenting monthly consultations with the director and all supervisory activities provided to the laboratory; (j) Ensure that laboratory testing personnel: (i) Possess the education, training, and experience required to perform and report laboratory test results accurately and promptly; (ii) Are sufficient in number for the scope and complexity of the services provided; (iii) Receive regular in-service training and continuing education appropriate for the scope and complexity of the services provided; and (iv) Maintain competency in performing test procedures and reporting test results; and (k) Perform other duties and responsibilities as delegated and authorized by the director that may include assisting in: (i) Developing cost benefit data; (ii) Identifying and recommending adjustments to a laboratory's scope of services; and (iii) Recommending the purchase or replacement of test kits, reagents, and equipment. #### Regulation .03 Permitted POL and POCL — Consulting Supervisor Services. *COMAR 10.10.07.03* A. General. (1) A licensee operating a permitted POL or POCL who does not employ or otherwise engage technical personnel who qualify as a general supervisor shall arrange with a qualified consulting supervisor to provide technical and general supervisory consultation services in laboratory practice. (2) The licensee operating a POL or POCL under a permit shall use a consulting supervisor who: (a) Makes and documents on-site visits to each laboratory facility at least twice each calendar year; (b) Is available by telephone during the laboratory's regular operating hours; and (c) Completes a laboratory inspection checklist, provided by the OHCQ, to be submitted to the OHCQ not more than once every 2 years. B. Additional Visits. The OHCQ may require more than two on-site visits per year by a consulting supervisor when: (1) A laboratory exhibits unsatisfactory proficiency testing performance; (2) An on-site survey by the OHCQ shows that: (a) A laboratory is not in substantial compliance with the applicable standards and requirements of this chapter; (b) A laboratory's written plan of correction in response to a Department survey does not ensure substantial compliance with the applicable standards and requirements of this chapter; or (c) A laboratory's testing personnel require additional supervisory consultations to obtain or maintain proficiency in quality assurance, performing or reporting test results, or meeting other applicable standards of this chapter; (3) An inspection checklist submitted by the laboratory shows that the laboratory is operating in a manner that is not in compliance with applicable standards of this chapter; or (4) The laboratory's general supervisor or consulting supervisor has been unable to perform the duties and responsibilities set forth in Regulation .02B(4) of this chapter. #### Regulation .04 Permitted Laboratory Other than a POL or POCL — Director. *COMAR 10.10.07.04* A. Primary Standard. A licensee operating a permitted laboratory other than a POL or POCL shall employ a director who meets the applicable qualifications, responsibilities, and standards set forth in this chapter. B. Standards. (1) Qualifications. In addition to applicable personnel standards set forth in this chapter, a director shall meet the applicable standards set forth in 42 CFR §493.1443. (2) Responsibilities. A director shall carry out the applicable responsibilities set forth in 42 CFR §§493.1407 and 493.1445. (3) Associate Director. A director shall designate another individual who qualifies as a director under this chapter to serve as an associate or substitute director when the director: (a) Will be away from the laboratory for a period of more than 30 days; or (b) Is unable to carry out the responsibilities set forth in §B(2) of this regulation. (4) Communications. A director shall communicate with the laboratory's supervisory personnel in person, in writing, or by telephone at least once a month regarding the performance and operation of the laboratory. (5) On-site Visits. A director of a laboratory shall conduct an on-site visit of the laboratory at least once a month. (6) Limitation. The director of a permitted laboratory may not serve as director or associate director, or both, of more than five medical laboratories at the same time. #### Regulation .05 Permitted Laboratories — Technical Supervisors. *COMAR 10.10.07.05* A. Primary Standards. (1) A laboratory director certified, or eligible for certification, in anatomic and clinical pathology by the American Board of Pathology qualifies as a technical supervisor in all disciplines and subdisciplines set forth in COMAR 10.10.01.03B, except: (a) Genetics; and (b) Forensic toxicology. (2) A licensee who does not employ or otherwise engage a director certified in anatomic and clinical pathology by the American Board of Pathology, or a licensee operating a laboratory that performs testing in the discipline of genetics or forensic toxicology shall employ the services of a technical supervisor for each discipline set forth in COMAR 10.10.01.03B except the discipline of health awareness testing. (3) A technical supervisor shall carry out the applicable responsibilities set forth in 42 CFR §493.1451. B. Standards. (1) Requirement. A licensee operating a laboratory that performs testing in one or more disciplines shall employ a director or technical supervisor who meets the qualifications for a technical supervisor in the applicable disciplines or subdisciplines set forth in §B(2)—(13) of this regulation. (2) Chemistry. A technical supervisor shall possess a bachelor's or higher degree including significant studies in chemistry and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in clinical chemistry. (3) Gynecologic Cytology. A technical supervisor shall meet the requirements set forth in 42 CFR §493.1449. (4) Dermatopathology. A technical supervisor shall be: (a) A physician licensed by the Board of Physicians to practice medicine in the State; and (b) Either certified or eligible for certification in dermatopathology or anatomic pathology by the: (i) American Board of Dermatology; (ii) American Osteopathic Board of Dermatology; (iii) American Board of Pathology; or (iv) American Osteopathic Board of Pathology. (5) Forensic Toxicology — General Qualifications. A technical supervisor shall: (a) Be certified in toxicological chemistry by the American Board of Clinical Chemistry; (b) Be certified in forensic toxicology by the American Board of Forensic Toxicology; (c) Be certified in clinical pathology and chemistry by the American Board of Pathology; or (d) Possess education and experience in toxicology equivalent to that required by one of these boards. (6) Forensic Toxicology — Alternative Qualifications. An individual who does not qualify as a technical supervisor under §B(5) of this regulation may qualify as a technical supervisor if the individual: (a) Can document training or experience, or both, in the: (i) Analysis of biological material for alcohol or controlled dangerous substances, or both; and (ii) Forensic applications of analytical toxicology, such as court testimony, use of chain of custody, and specimen security; and (b) Possesses: (i) A degree in medicine or osteopathy acceptable for licensure as a physician by the Maryland State Board of Physicians, with certification in clinical pathology or forensic pathology, and have at least 2 years of laboratory experience in analytical toxicology; (ii) A doctoral degree in a biological, chemical, pharmacological, or toxicological discipline and have at least 2 years of laboratory experience in analytical toxicology; or (iii) A master's degree in a biological, chemical, pharmacological, or toxicological discipline with at least 6 years of experience in analytical toxicology. (7) Genetics. A technical supervisor of biochemical genetics, cytogenetics, or molecular genetics shall possess: (a) A degree in medicine or osteopathy acceptable for licensure as a physician by the Maryland State Board of Physicians; or (b) An earned doctorate in one of the biological or chemical sciences from an accredited institution with: (i) 4 years of laboratory experience in genetics; or (ii) Eligibility for certification by the American Board of Medical Genetics. (8) Hematology. A technical supervisor shall possess a baccalaureate or higher degree including studies in biology or general cytology and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in hematology. (9) Immunology. A technical supervisor shall possess a baccalaureate or higher degree including studies in immunology, microbiology, or chemistry and have at least 4 years post-baccalaureate or 2 years post-master's experience in immunology-serology. (10) Microbiology. A technical supervisor shall possess a baccalaureate or higher degree including studies in microbiology or immunology and have at least 4 years post-baccalaureate or 2 years post-master's medical laboratory experience in clinical microbiology. (11) Molecular Biology. A technical supervisor shall possess a baccalaureate or higher degree including studies in molecular biology and have at least 4 years post-baccalaureate or 2 years post-master's experience in molecular biology, microbiology, immunology, or clinical chemistry. (12) Oral Pathology, Including Oral Cytopathology. A technical supervisor shall be a dentist or physician licensed to practice in Maryland and be certified or eligible for certification by the American Board of Oral Pathology, American Board of Pathology, or the American Osteopathic Board of Pathology. (13) Tissue Pathology. A technical supervisor shall be a physician licensed to practice medicine in Maryland and be certified or eligible for certification in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. #### Regulation .06 Permitted Laboratory Other than a POL or POCL — Supervisors. *COMAR 10.10.07.06* A. Primary Standard. A licensee operating a laboratory other than a POL or POCL shall employ a qualified supervisory technologist or general supervisor, who in the absence of the director or technical supervisor is responsible for the proper performance of laboratory procedures and reporting of laboratory test results. B. Standards: General Supervisor. (1) Personnel Qualifications. A general supervisor shall be a technologist who possesses at least 4 years technical experience in a licensed medical laboratory other than a laboratory operating under a letter of exception. (2) Responsibilities. A general supervisor shall carry out the responsibilities set forth in 42 CFR §493.1463. C. Standards: Supervisory Cytotechnologist. (1) Personnel Qualifications. For the specialty of cytology, a laboratory shall employ the services of a supervisory cytotechnologist who meets the qualifications set forth in 42 CFR §493.1469. (2) Responsibilities. A supervisory cytotechnologist shall carry out the responsibilities set forth in 42 CFR §493.1471. D. Standards: Supervisor of Blood Gas Analyses. An individual qualifies as a supervisor of blood gas analyses by: (1) Possessing an earned doctoral, master's, or baccalaureate degree in respiratory care or cardiovascular technology; and (2) Meeting the personnel qualifications set forth in 42 CFR §493.1449. #### Regulation .07 Permitted Laboratory Other than POL or POCL — Testing Personnel. *COMAR 10.10.07.07* A. Primary Standard. A permitted laboratory other than a POL or POCL shall employ or engage testing personnel, sufficient in number to perform testing for the volume and complexity of testing performed, who meet the qualifications and carry out the responsibilities set forth in this regulation. B. Standards — General. (1) Personnel Qualifications. An individual performing one or more laboratory tests shall meet the applicable qualifications set forth in 42 CFR §493.1423. (2) Responsibilities. Testing personnel shall carry out the responsibilities set forth in 42 CFR §493.1425. C. Standards — Cytotechnologist. (1) Personnel Qualifications. For the specialty of cytology, a licensee shall employ the services of cytotechnologists who meet the qualifications set forth in 42 CFR §§493.1483. (2) Responsibilities. A cytotechnologist shall carry out the responsibilities set forth in 42 CFR §493.1485. D. Standards — Blood Gas Analysis — Personnel Qualifications. Personnel performing blood gas analyses shall: (1) Meet the standards set forth in 42 CFR §493.1489; or (2) Complete a 1-year certificate program in respiratory care. ### Chapter 08 — Medical Laboratories — Sanctions **Authority:** Health-General Article, §§17-202, 17-206, 17-210, 17-211, and 17-509, Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02A, B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .02B amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04B amended effective June 1, 2009 (36:11 Md. R. 787) **Administrative History:** Regulation .05 adopted effective March 27, 2006 (33:6 Md. R. 578) #### Regulation .01 General. *COMAR 10.10.08.01* A. Authority and Types. (1) The Secretary may impose one or more principal or alternative sanctions. (2) Principal Sanctions. The Secretary may impose the following principal sanctions: (a) Denial of a license; (b) Suspension of a license; and (c) Revocation of a license. (3) Alternative Sanctions. Instead of or in conjunction with lifting a principal sanction, the Secretary may impose one or more of the following alternative sanctions: (a) A directed plan of correction; (b) Limitation on testing; and (c) Training and technical assistance. B. Reasons for Imposition. A laboratory is subject to the imposition of one or more sanctions when the OHCQ finds: (1) A deficiency identified through an on-site survey or a review of materials submitted by a laboratory, such as applications data, personnel qualification materials, and self-inspection checklists; (2) Unsuccessful proficiency testing performance; (3) Demonstrated incompetence, such as showing consistent or repetitive errors in operating equipment or in performing a test or procedure; (4) False statements made on an application, plan-of-correction, or other form submitted to the OHCQ; (5) Misrepresentation in obtaining a permit or letter of exception or in operating a laboratory; (6) Failure to comply with the: (a) Cancer reporting requirements of Health-General Article, §18-204, Annotated Code of Maryland; and (b) Infectious disease and submission of clinical material requirements of Health-General Article, §18-205, Annotated Code of Maryland, and COMAR 10.06.01; (7) Submission of a specimen by a laboratory inside the State to another laboratory that does not possess a license as set forth in COMAR 10.10.03; (8) Conviction by a court of a violation of the laws of the State pertaining to a medical laboratory; or (9) Exceeding the 50 test per year limit when operating under a letter of exception—limited testing for rare diseases as set forth in COMAR 10.10.03.05B. C. Factors Affecting Choice of Sanctions. The Secretary shall choose which sanctions to apply to a laboratory based on, but not limited to, the following: (1) Whether a deficiency poses immediate jeopardy to personal or public health or safety; (2) The nature, incidence, severity, and duration of the deficiency; (3) Whether a deficiency has been identified repeatedly; (4) The inaccuracy or extent of missing laboratory records, such as missing documentation of remedial action or failure to make records available to the OHCQ; (5) The relationship of one deficiency or group of deficiencies to another deficiency; (6) The overall compliance history of a laboratory, including but not limited to any period of noncompliance that occurred between determinations of compliance; (7) The corrective and long-term compliance outcomes the Secretary intends to effect through application of the sanction; and (8) The progress a laboratory has made toward regulatory compliance following a reasonable opportunity to correct a deficiency. D. Mandatory Revocation of a License. The Secretary shall revoke for 1 year the license of a laboratory that intentionally refers a proficiency test sample to another laboratory for analysis. E. Owning and Operating Prohibition Following Revocation. A person who has owned, operated, or directed a laboratory that has had its license revoked may not, within 1 year of the revocation, apply for a license, or own or operate a laboratory for which a license has been issued under this chapter. #### Regulation .02 Departmental Actions — General. *COMAR 10.10.08.02* A. Deficiency Posing Immediate Jeopardy. (1) If a laboratory's deficiency poses immediate jeopardy to personal or public health or safety, the Secretary shall take one or more of the actions listed in §A(2) and (3) of this regulation. (2) Initial Actions. When a deficiency involving immediate jeopardy is first identified, the Secretary shall: (a) Require the laboratory to take immediate action to remove the jeopardy; and (b) Impose: (i) A principal sanction after giving the laboratory at least 24 hours notice; or (ii) One or more alternative sanctions. (3) Follow-up Actions. If the OHCQ finds in a follow-up survey of a laboratory under an alternative sanction that the laboratory has not eliminated the immediate jeopardy, the Secretary shall impose a principal sanction after giving the laboratory at least 24 hours notice. B. Deficiency Not Posing Immediate Jeopardy. (1) If a laboratory's deficiency does not pose immediate jeopardy to personal or public health or safety, the Secretary may take one or more of the actions listed in §B(2) — (4) of this regulation. (2) Initial Actions. When a deficiency is first identified, the Secretary may impose one or more alternative sanctions or a principal sanction. (3) Unsatisfactory Proficiency Testing. If a laboratory exhibits unsatisfactory proficiency testing performance, as set forth in COMAR 10.10.01.03B, the Secretary may impose the training and technical assistance requirements set forth in Regulation .04 of this chapter as a directed plan of correction, as well as any other sanction. (4) Follow-up Actions. If the OHCQ finds in a follow-up survey that a laboratory has not corrected a deficiency within 30 days after it was identified, the Secretary may: (a) Impose, or continue if already imposed, one or more sanctions; (b) Conduct one or more on-site visits to evaluate progress in correcting a deficiency; and (c) Conduct an additional follow-up survey to determine whether all corrections have been made. C. Duration of a Sanction. A sanction shall remain in force until: (1) A laboratory corrects the deficiency; or (2) A laboratory's license is revoked. D. Lifting of a Sanction. (1) General Rule. The Secretary may not lift a sanction until regulatory compliance is verified. (2) Credible Allegation of Compliance. When a sanctioned laboratory submits a credible allegation of compliance, the Secretary shall: (a) Determine compliance on the basis of the evidence submitted by the laboratory in its allegation; (b) Conduct a follow-up survey to verify whether the laboratory has achieved compliance; or (c) Both §D(2)(a) and (b) of this regulation. (3) If a laboratory does not correct all deficiencies within 30 days after imposition of a sanction, the Secretary may initiate action to suspend or revoke the license. #### Regulation .03 Departmental Actions — Principal Sanctions. *COMAR 10.10.08.03* A. Hearing Requirement. (1) Except when the Secretary finds that a danger to public health or safety imperatively requires that emergency action be taken to correct a deficiency, the Secretary shall inform the licensee in writing when a suspension or revocation of the licensee's license takes effect, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter before the suspension or revocation takes effect, as provided in State Government Article, §10-226, Annotated Code of Maryland. (2) When a finding is made that the public health or safety imperatively requires that emergency or immediate action be taken, the Secretary shall inform the licensee in writing of a suspension or revocation of the licensee's license, the reason for the suspension or revocation, and that the licensee has an opportunity for a hearing on the matter, as provided in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, after the suspension or revocation. B. Notice. (1) Contents. In cases involving a principal sanction, the Secretary shall give written notice to a licensee of the: (a) Deficiency identified; (b) Sanction proposed for imposition; (c) Reason for the proposed sanction; (d) Projected effective date and duration of the proposed sanction; (e) Authority for the proposed sanction; and (f) Time allowed for a laboratory to respond to the notice. (2) Opportunity to Respond. During the time allowed and stated in the written notice, a laboratory may submit to the Secretary written evidence or other information against imposition of the proposed sanction or sanctions. (3) Notice Times. (a) If a deficiency is found imperatively to require emergency or immediate action, the Secretary shall provide notice at least 24 hours before the effective date of sanction. (b) If a deficiency is found to warrant a principal sanction but does not imperatively require emergency or immediate action, the Secretary shall provide notice at least 10 days before the effective date of sanction. (c) To preserve its right to a hearing, a licensee shall request a hearing within 10 days of its receipt of the notice of the pending sanction. #### Regulation .04 Enforcement Procedures — Proficiency Testing. *COMAR 10.10.08.04* A. Application. If a laboratory's performance in proficiency testing is unsuccessful or unsatisfactory, as set forth in COMAR 10.10.05, the Secretary may require the laboratory to undertake the directed plan of correction of the training of its personnel or the obtaining of necessary technical assistance, or both, in order to meet the proficiency testing requirements of this chapter. B. Procedures. A laboratory required to undertake training of personnel or to obtain necessary technical assistance shall: (1) Document the training or assistance, or both, using forms provided by the OHCQ; and (2) Submit the completed forms to the OHCQ. #### Regulation .05 Departmental Action — Reporting Erroneous or Questionable Patient Test Results. *COMAR 10.10.08.05* A. If the Department determines that a licensee has reported an erroneous or questionable patient test result that threatens the health or safety of the patient, the Secretary may order the licensee, within a specified period of time, to: (1) Give prompt notice of the erroneous or questionable patient test result to the: (a) Person who requested that the test be performed; and (b) Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result; (2) Provide corrected reports to the persons notified in §A(1) of this regulation; (3) Maintain duplicates of both the original report and the corrected report; (4) Conduct a quality assessment of all phases of the testing process to: (a) Determine the cause of the erroneous or questionable test result; and (b) Take the necessary remedial or corrective action to prevent recurrence of the problem; and (5) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including: (a) Notifying the: (i) Patient; (ii) Community at large if the Secretary determines that the licensee's laboratory operation is a threat to patient health and safety; and (iii) If the licensee is unable to notify a patient, the Department; and (b) Retesting: (i) The same specimen; (ii) A new specimen; or (iii) Both the same specimen and a new specimen. B. Civil Penalty for Failure to Comply with Order. (1) A laboratory that fails to comply with an order issued by the Secretary under §A of this regulation is subject to a civil penalty of up to $1,000 for each day of noncompliance, up to a maximum of $50,000. (2) The Secretary may impose the civil penalty instead of or in addition to any other sanction imposed under this chapter. C. Notice and Hearing. (1) Notice. Before the Secretary imposes a civil penalty for noncompliance as provided in §B of this regulation, the Secretary shall give written notice to the licensee: (a) Of the intent to impose a civil money penalty; and (b) That the licensee has an opportunity for a hearing on the matter before the civil penalty is imposed. (2) Content. The Secretary shall give written notice to the licensee of the: (a) Reason for the imposition of the civil penalty; (b) Amount of the civil penalty; (c) Effective date of the imposition of the civil penalty; (d) Time allowed for the licensee to respond to the notice; and (e) Authority for imposing the civil penalty. (3) Opportunity to Respond. During the time allowed and stated in the written notice from the Secretary, the licensee may submit to the Secretary written evidence or other information to support the position that the licensee has not violated the requirements of this regulation or Health-General Article, §17-210, Annotated Code of Maryland. (4) To preserve the right to a hearing, the licensee shall request a hearing within 10 days of receipt of the notice of the Secretary's intent to impose the civil penalty. D. Factors to Be Considered in the Assessment of Penalties. In cases in which the Secretary determines that the imposition of a civil penalty is appropriate, the Secretary shall take into consideration the following factors in determining the amount of the penalty: (1) The extent to which the licensee derived any financial benefit from reporting erroneous or questionable patient test results; (2) The willfulness on the part of the licensee; (3) The extent of actual or potential public harm caused by reporting erroneous or questionable patient test results; (4) The cost of investigating and prosecuting the case against the licensee; (5) The licensee's history of previous failure to meet the standards of this subtitle; and (6) The existence of mitigating factors. E. Payment of Penalties. (1) At the Secretary's discretion, the Secretary may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. (2) All monies collected by the Secretary pursuant to this regulation shall be paid into the General Fund of the State. ### Chapter 09 — Forensic Laboratories — Personnel Certification and Approval of Laboratory Procedures **Authority:** Courts and Judicial Proceedings Article, §10-1001; Health-General Article, §17-2A-02; Annotated Code of Maryland **Administrative History:** Effective date: March 11, 1985 (12:5 Md. R. 483) **Administrative History:** Regulation .02A amended effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulations .03 and .04 repealed, new Regulations .03—.06 adopted effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulation .05 recodified as Regulation .07 effective August 6, 1990 (17:15 Md. R. 1859) **Administrative History:** Regulation .06 amended effective March 1, 1993 (20:4 Md. R. 371) **Administrative History:** Chapter revised effective April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Chapter recodified from COMAR 10.10.03 and revised effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .01 amended effective November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .01A amended effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .02 amended effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .02A amended effective November 11, 2013 (40:22 Md. R. 1877) **Administrative History:** Regulation .03 amended effective December 23, 2002 (29:25 Md. R. 1982); November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .03A amended as an emergency provision effective September 10, 2019 (46:20 Md. R. 842); adopted permanently effective December 30, 2019 (46:26 Md. R. 1165) **Administrative History:** Regulation .04 amended effective December 23, 2002 (29:25 Md. R. 1982); November 11, 2013 (40:22 Md. R. 1877) **Administrative History:** Regulation .05 amended effective December 23, 2002 (29:25 Md. R. 1982) #### Regulation .01 Qualifications. *COMAR 10.10.09.01* A. Certified Chemist and Certified Chemical Analyst. An applicant for certified chemist or certified chemical analyst shall: (1) Hold a bachelor's degree from an accredited college or university with a major in chemistry, medical technology, biology, physics, pharmacy, pharmacology, or forensic science; (2) Have completed courses in analytical and organic chemistry; and (3) Have completed a basic training program for certified chemist or certified chemical analyst as set forth in Regulation .02 of this chapter. B. Certified Analyst. An applicant for certified analyst shall: (1) Possess a high school diploma or its equivalent; (2) Have completed a basic training program for certified analyst as set forth in Regulation .02 of this chapter; and (3) Identify in the application those specific drug-testing procedures for which certification is being sought and for which training has been received. #### Regulation .02 Approved Training Programs for Chemists, Chemical Analysts, and Analysts. *COMAR 10.10.09.02* A. Certified Chemist. (1) An applicant for certification as a certified chemist shall have successfully completed: (a) The basic training program for forensic drug chemists offered by the United States Department of Justice, Drug Enforcement Administration; or (b) A training program in the discipline of controlled dangerous substances provided by a forensic laboratory licensed by the Department. (2) The applicant shall demonstrate completion of the training program referenced in §A(1)(b) of this regulation by providing the Department with the forensic laboratory director’s written authorization for that individual to perform casework independently in the discipline of controlled dangerous substances. B. Certified Chemical Analyst. An applicant for certification as a certified chemical analyst shall have successfully completed a basic training program approved by the Department that provides training in the identification of marijuana or marijuana products, or both, cocaine base, cocaine hydrochloride, and heroin using procedures approved under Regulation .04 of this chapter. C. Certified Analyst. An applicant for certification as a certified analyst shall have successfully completed a basic training program approved by the Department that provides training in the identification of marijuana or marijuana products, or both, using procedures approved under Regulation .04 of this chapter. #### Regulation .03 Employment, Employment Certification, and Automatic Decertification. *COMAR 10.10.09.03* A. Employment. An individual applying for certification under this chapter shall be currently employed by: (1) The Department; (2) The Maryland State Police; (3) The Baltimore City Police Department; (4) The police department or a municipality or county in this State; or (5) A private forensic laboratory licensed by the Maryland Department of Health that has a contract with a Maryland law enforcement agency to provide testing services for controlled dangerous substances. B. Employment Certification. An applicant's supervisor shall certify that the applicant is currently employed by an agency listed in §A of this regulation by signing the employment certification section of the application. C. Certification and Automatic Decertification. (1) Certification under this chapter is only valid when the individual is employed by an agency listed in §A of this regulation. (2) An individual certified under this chapter is automatically decertified when the individual: (a) Is no longer employed by the agency that certified employment; (b) Retires from the agency that certified employment; or (c) Changes employment from one agency listed in §A of this regulation to another agency listed in §A of this regulation. (3) An individual shall reapply for certification under this chapter if the individual is: (a) Rehired by the same agency that previously certified employment; or (b) Hired by a different agency listed in §A of this regulation. #### Regulation .04 Procedures. *COMAR 10.10.09.04* Chemists, chemical analysts, and analysts certified under this chapter are certified only when performing those drug identification procedures: A. Approved by a forensic laboratory licensed by the Department; or B. Contained in the “Forensic Chemists and Analysts Training and Procedures Manual” 1992, which is incorporated by reference. #### Regulation .05 Report. *COMAR 10.10.09.05* A report prepared pursuant to these regulations shall contain the following information: A. The signature of the certified chemist, chemical analyst, or analyst performing the drug-identification procedure; B. The name of the person who delivered the material to be tested to the certified chemist, chemical analyst, or analyst; C. A statement that the chemist, chemical analyst, or analyst has been certified by the Department to perform the procedures identified in the report; D. A statement by the certified chemist, chemical analyst, or analyst that the results contained in the report were reached using procedures approved by the Department; E. A statement by the certified chemist, chemical analyst, or analyst concerning whether the material tested is, or contains, the drug identified in the report; and F. A statement by the certified chemist, chemical analyst, or analyst that quality control of the drug-identification procedures was performed to ensure the reliability of the procedures performed. ### Chapter 10 — Job-Related Alcohol and Controlled Dangerous Substances Testing **Authority:** Health-General Article, §§17-202 and 17-214, Annotated Code of Maryland **Administrative History:** Effective date: October 5, 1998 (25:20 Md. R. 1529) **Administrative History:** Chapter, COMAR 10.10.05, recodified to COMAR 10.10.10 effective December 13, 1999 (26:25 Md. R. 1897) **Administrative History:** Regulation .03B amended effective February 18, 2002 (29:3 Md. R. 220); December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .06 amended effective February 18, 2002 (29:3 Md. R. 220); December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .10 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .10F amended effective July 22, 2002 (29:14 Md. R. 1074) #### Regulation .01 Purpose. *COMAR 10.10.10.01* This chapter provides for the protection of employers, employees, and the public by setting fair and effective job-related alcohol and controlled dangerous substances testing standards to ensure accurate and reliable test results and to promote drug-free workplaces. #### Regulation .02 Scope. *COMAR 10.10.10.02* A. This chapter provides the standards and procedures that employers, employees, and the Secretary shall meet when job applicants and employees are required to undergo job-related alcohol and controlled dangerous substances testing. B. This chapter does not apply to: (1) A person who is subject to federal or State commercial motor vehicle statutes or regulations concerning alcohol and controlled dangerous substances testing, to the extent that those statutes or regulations conflict with the requirements of this chapter; (2) An agency of the federal government; (3) Alcohol or controlled dangerous substances testing of an individual under arrest or held by a law enforcement or correctional agency; (4) Alcohol testing conducted by a law enforcement or correctional agency on breath-testing equipment certified by the State toxicologist; or (5) Controlled dangerous substances testing by a laboratory facility of a law enforcement or correctional agency that maintains laboratory testing standards comparable to the standards in Health-General Article, §17-214, Annotated Code of Maryland. #### Regulation .03 Definitions. *COMAR 10.10.10.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Agent of the employer” means a person other than the employer or a licensed medical laboratory that employs individuals who perform preliminary screening of job applicants for controlled dangerous substances on behalf of the employer. (2) “Chain-of-custody” means a method of tracking an individual's specimen for the purpose of maintaining control and accountability from initial collection through each stage in handling, testing, storing, reporting test results, and final specimen disposition. (3) Confirmation Test. (a) “Confirmation test” means an analytical procedure performed after a preliminary or screening test and intended to verify or positively identify the presence of a controlled dangerous substance in a specimen. (b) “Confirmation test” is limited to an analytical procedure that employs a combination of gas chromatography and mass spectrometry (GC/MS or GC/MS/MS) or mass spectrometry and mass spectrometry (MS/MS). (4) Controlled Dangerous Substance. (a) “Controlled dangerous substance” means a drug, substance, or immediate precursor as set forth in Schedules I—V, Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. (b) “Controlled dangerous substance” includes new substances controlled under federal law as provided in Criminal Law Article, §5-202, Annotated Code of Maryland. (5) Employee. (a) “Employee” means an individual who performs work for an employer. (b) “Employee” includes a salaried, contractual, full-time, part-time, temporary, hourly, and on-call employee or a volunteer. (6) “Employer” means a person who employs an individual to perform work. (7) “Forensic testing” means testing performed for a nonclinical purpose and under procedures that produce test results that meet rules of evidence required in a court of law. (8) “Immediate precursor” means a substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland. (9) “Independent test” means a test performed at the request and expense of a job applicant, employee, or contractor to verify a test result obtained on the same specimen. (10) “Job applicant” means an individual who has applied for a position with an employer but is not currently employed by the employer. (11) “Job-related testing” means any alcohol or controlled dangerous substances testing used by an employer for a lawful business purpose. (12) Laboratory. (a) “Laboratory” means a facility, entity, or site that performs job-related alcohol or controlled dangerous substances testing. (b) “Laboratory” does not include a collection site or other site where an employer or agent of the employer performs preliminary screening of job applicants for a controlled dangerous substance using a single-use test device for forensic testing. (13) “Letter of registration” means the authority in the form of a letter issued by the Secretary granting permission to an employer to perform preliminary screening of job applicants for a controlled dangerous substance. (14) “License” means the authority in the form of a permit issued by the Secretary granting permission for a laboratory to perform job-related alcohol or controlled dangerous substances testing. (15) “Medical review officer” means a licensed physician with knowledge of drug abuse disorders and drug and alcohol testing who is either employed or under contract to an employer that performs preliminary screening of job applicants for a controlled dangerous substance. (16) “Non-negative test result” means the result of a preliminary screening for a controlled dangerous substance that is not negative but that has not been confirmed by a licensed laboratory. (17) “Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health. (18) “Operator” means an individual employed by the employer or agent of the employer who performs a preliminary screening procedure as defined in §B(19) of this regulation. (19) “Preliminary screening procedure” means a controlled dangerous substance test: (a) Using a single-use test device for forensic testing; and (b) Performed by an employer or agent of the employer on a job applicant. (20) “Secretary” means the Secretary of Health or the Secretary's designee. (21) “Single-use test device for forensic testing” means the reagent-containing unit of a test system that: (a) Is in the form of a sealed container or cartridge possessing a validity check; (b) Possesses a nonresealable closure or an evidentiary tape to ensure detection of tampering; (c) Is self-contained and individually packaged; (d) Is discarded after each test; and (e) Does not allow any test component or constituent of a test system to interact from test to test. (22) Specimen. (a) “Specimen” means material derived from the human body and intended for laboratory testing. (b) “Specimen” is limited to blood, urine, saliva, and hair. #### Regulation .04 Responsibilities of the Secretary. *COMAR 10.10.10.04* A. Registration. (1) Requirement. The OHCQ shall register on the Secretary's behalf an employer that conducts a preliminary screening procedure on a job applicant for a controlled dangerous substance. (2) Forms. The OHCQ shall provide to each employer: (a) A registration application form; and (b) A registration renewal form every 2 years after the initial registration. B. Routine Surveys and Complaint Investigation. (1) Requirement. The Secretary or the OHCQ as the Secretary's designee shall: (a) Conduct routine surveys of preliminary screening sites; (b) Conduct surveys of preliminary screening sites as part of a complaint investigation; and (c) Investigate written complaints related to compliance with the standards set forth in this chapter. (2) On-site Surveys. The OHCQ may: (a) Annually conduct routine on-site surveys of preliminary screening sites; (b) Conduct a routine survey any time during a preliminary screening site's normal work hours; and (c) Include as part of a routine survey or complaint investigation: (i) On-site observation and examination of preliminary screening facilities, equipment, screening devices, specimens, and screening procedures; (ii) On-site examination of documents pertinent to employer registration, preliminary screening performed by the employer or agent of the employer, and operator training; and (iii) On-site interviews of employers and employees involved in performing, supervising, or managing preliminary screening. (3) Sanctions. (a) Imposition. If the Secretary finds that an employer or agent of an employer is not in compliance with a requirement or standard of this chapter, the Secretary may impose one or more of the following sanctions on the employer, agent of the employer, or both: (i) Suspension of a letter or letters of registration; (ii) Revocation of a letter or letters of registration; (iii) A direct plan of correction; (iv) A limitation on preliminary screening; and (v) Required training and technical assistance. (b) Departmental Actions. The Secretary shall carry out actions related to the imposition or lifting of sanctions involving preliminary screenings in the same manner as those involving a laboratory, as set forth in COMAR 10.10.08, including the providing of notice and hearings. #### Regulation .05 Employer Requirements. *COMAR 10.10.10.05* An employer who for job-related reasons requires an individual to be tested for alcohol or controlled dangerous substances shall: A. Have the specimen tested by a laboratory that holds a Maryland license in the discipline of job-related alcohol and controlled dangerous substances testing; and B. At the time of testing and at the individual's request, inform the person of the name and address of the laboratory that will test the specimen. #### Regulation .06 Permissible Specimens. *COMAR 10.10.10.06* A. General. An employer requiring job-related alcohol or controlled dangerous substances testing shall require that: (1) A job applicant provide only one or more of the following types of specimen: (a) Blood; (b) Urine; (c) Saliva; and (d) Hair; and (2) An employee or contractor provide only one or more of the following types of specimen: (a) Blood; (b) Saliva; and (c) Urine. B. Specimen Types. An employer requiring job-related alcohol or controlled dangerous substances testing may not require the testing of any specimen other than: (1) Blood, urine, saliva, or hair, for a job applicant; and (2) Blood, saliva, or urine, for an employee or contractor. C. Hair. An employer may require that a job applicant submit a hair specimen for controlled dangerous substances testing if the hair specimen is: (1) Less than or equal to 1-1/2 inches in length measured from the human body; (2) Tested only for preemployment purposes; and (3) Not used for a purpose other than controlled dangerous substances testing. #### Regulation .07 Specimen Collection and Handling Procedures. *COMAR 10.10.10.07* A. Chain of Custody. A person collecting a specimen shall employ quality assurance and chain-of-custody procedures that include: (1) Collecting a specimen in a sealed container that has a non-resealable closure or an evidentiary tape that assures detection of any tampering; (2) Collecting, handling, storing, and shipping a specimen in a manner that: (a) Maintains its identity, confidentiality, and physical integrity; and (b) Precludes specimen contamination or adulteration; and (3) Documenting each time a person accesses or transfers the specimen. B. Specimen Quantity. A person collecting a specimen shall collect a quantity sufficient to perform an initial screening test, a confirmation test, and an independent test. #### Regulation .08 Protections for Job Applicants, Employees, and Contractors. *COMAR 10.10.10.08* A. Notice of Positive Test Results. (1) An employer who requires a job applicant, employee, or contractor to be tested for job-related reasons for the use or abuse of a controlled dangerous substance or alcohol and who receives notice that a job applicant, employee, or contractor has tested positive for a controlled dangerous substance or alcohol shall provide to the job applicant, employee, or contractor with a confirmed positive test result: (a) A copy of the laboratory test indicating the test results; (b) A copy or written summary of the employer's policy covering an employee, contractor, or job applicant with a confirmed positive test result; (c) If applicable, written notice of the employer's intent to take disciplinary action, terminate employment, or change the conditions of continued employment; and (d) A statement or copy of the provisions set forth in §B of this regulation permitting a job applicant, employee, or contractor to request independent testing of the same sample for verification of the test result. (2) The employer shall deliver the information required to be provided under §A of this regulation to the job applicant, employee, or contractor: (a) Either in person or by certified mail; and (b) Within 7 days from the date confirmed positive test results are received by the employer. B. Right to an Independent Test. (1) Challenge. A job applicant, employee, or contractor who is required to submit to job-related alcohol or controlled dangerous substances testing may request that an independent test be performed on the same specimen in a confirmation test by: (a) Notifying the employer and the laboratory that performed the confirmation test of the challenge to that test result; and (b) Requesting that laboratory to submit a sufficient portion of the original specimen to a different laboratory chosen by the job applicant, employee, or contractor and licensed by the Secretary to perform alcohol or controlled dangerous substances testing. (2) Testing Sensitivity. The job applicant, employee, or contractor shall employ as an independent testing laboratory one that will perform the independent test using detection levels for alcohol or controlled dangerous substances equal to or lower than those provided by the laboratory that performed the initial confirmation test. (3) Costs. The job applicant, employee, or contractor shall pay all costs of independent testing including any costs associated with specimen handling and transport. #### Regulation .09 Confidentiality. *COMAR 10.10.10.09* A. General. Except as otherwise provided in an employer's written drug testing policy, in this regulation, or in Health-General Article, §17-214, Annotated Code of Maryland, all information, interviews, reports, statements, memoranda, and test results received or produced as a result of job-related alcohol or controlled dangerous substances testing are confidential and may be released only under a lawful subpoena, court order, or a release signed by the individual tested, or, in the case of a minor, by the individual's parent or legal guardian. B. Nonprescription and Medically Prescribed Drugs. In the course of obtaining information for, or as a result of, conducting job-related alcohol or controlled dangerous substances testing for an employer, a laboratory, a physician, including a physician retained by the employer, or any other person, may not reveal to the employer information regarding the use of a: (1) Nonprescription drug, excluding alcohol, that is not prohibited under the laws of the State; or (2) Medically prescribed drug, unless the individual being tested is unable to establish that the drug was medically prescribed under the laws of the State. #### Regulation .10 Preliminary Screening by an Employer or Agent of the Employer. *COMAR 10.10.10.10* A. In addition to any other applicable requirements in this chapter, an employer or agent of the employer that performs a preliminary preemployment screening procedure for a controlled dangerous substance on a job applicant shall meet the standards set forth in this regulation. B. Registration Requirement. An employer or agent of the employer shall register the employer initially and every 2 years thereafter with the OHCQ by: (1) Submitting to the OHCQ a registration form that: (a) Lists the permanent office location of the employer and any agent of the employer in the State; (b) Lists the permanent locations where the employer or agent of the employer performs preliminary screenings; and (c) States whether the employer or agent of the employer performs preliminary screenings at temporary sites, uses mobile screening vehicles, or both; and (2) Submitting to the OHCQ a registration fee of $50. C. Single-Use Test Device. An employer or agent of the employer shall limit screening procedures to those that employ an FDA-cleared or approved single-use test device as defined in Regulation .03B(21) of this chapter. D. Trained Operator. To perform a preliminary screening procedure, an employer or agent of the employer shall employ an operator who has been trained for each type of device to be used, including instruction that includes the operator's: (1) Reading the test manufacturer's package insert sheet; (2) Observing the test manufacturer's training video or receiving training: (a) From the test manufacturer; (b) From an individual trained by the manufacturer; or (c) Endorsed by the manufacturer; (3) Completing the test manufacturer's self-administered test; and (4) Performing tests, interpreting test results, and reporting results to job applicants under the supervision of a trained operator. E. Training Records. (1) Requirement. An employer or agent of the employer shall establish and maintain training records that document the training required to properly perform a screening procedure. (2) Documentation. An employer or agent of the employer shall: (a) Keep a record of the training received by a trainee; (b) Document that a trainee has demonstrated competency in performing the screening procedure; and (c) Maintain for at least 2 years documentation that the trainee has been trained as set forth in this regulation. F. Quality Assurance. An employer or agent of the employer shall: (1) Limit screening procedures to those that employ an FDA-cleared or FDA-approved single-use test device for forensic testing, as defined in Regulation .03 of this chapter; (2) Perform preliminary screening tests in accordance with the quality standards set forth in COMAR 10.10.03.02C(2) and (3); (3) Collect and handle all specimens and ship non-negative specimens for testing, in a manner that: (a) Maintains the specimen donor's identity and confidentiality; and (b) Precludes contamination of and tampering with the specimen; (4) Provide a secure area with limited access to store a non-negative specimen before it is shipped to a laboratory and while it is retained pending: (a) Confirmatory testing; (b) Notice; (c) Any independent testing; and (d) Final disposal; (5) Submit a non-negative specimen subjected to a preliminary screening procedure to a licensed medical laboratory for confirmatory testing within 24 hours of screening; (6) Maintain a written record of the chain-of-custody for a specimen from the time it is collected until it is no longer needed for retesting or confirmatory testing; (7) Have a medical review officer, as defined in Regulation .03B(15) of this chapter, review positive test results resulting from a confirmatory test; and (8) Retain for at least 1 year all records pertaining to preliminary screening. G. Notice and Independent Testing. An employer or agent of the employer who receives notice that a job applicant has tested positive for a controlled dangerous substance shall: (1) Provide to the job applicant the items specified in Regulation .08A of this chapter; and (2) Inform the job applicant of the right to request that an independent test be performed on the same specimen, as set forth in Regulation .08B of this chapter. H. Voluntary Disclosure. (1) For the purposes of facilitating hiring, a job applicant may voluntarily disclose and provide documentation to an operator that the job applicant is using: (a) A nonprescription drug that is not prohibited under the laws of the State; (b) A medically prescribed drug; or (c) Both. (2) An operator may disclose to the employer information involving the use of medically prescribed and nonprohibited nonprescription drugs voluntarily disclosed and documented to the operator by the job applicant. I. Surveys and Complaint Investigations. An employer or agent of an employer shall permit the OHCQ to conduct an on-site survey of a preliminary screening site at any time during the screening site's normal hours of operation as part of a complaint investigation or routine inspection to determine compliance with the applicable requirements and standards set forth in this chapter. ### Chapter 11 — Biological Agents Registry Program **Authority:** Health-General Article, §§17-601—17-605, Annotated Code of Maryland **Administrative History:** Effective date: November 25, 2002 (29:23 Md. R. 1811) **Administrative History:** Chapter revised effective July 31, 2006 (33:15 Md. R. 1280) **Administrative History:** Chapter revised effective January 23, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .03B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .04B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .07F amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .10E amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .11A amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .12B, C amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .13 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .14 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .21 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .22 amended effective May 18, 2020 (47:10 Md. R. 517) #### Regulation .01 Purpose. *COMAR 10.10.11.01* The purpose of this chapter is to help protect the people of Maryland against the potential threat of biological terrorism by establishing a program to register persons that possess, maintain, transfer, or receive biological agents in the State. #### Regulation .02 Scope. *COMAR 10.10.11.02* A. This chapter contains the standards and requirements a person that possesses, maintains, transfers, or receives a biological agent in this State shall meet to comply with the registration of biological agents. B. This chapter does not apply to a biological agent or a certified laboratory or facility that is exempt from the requirements for the interstate shipment of etiologic agents under 42 CFR §§73.5 and 73.6, 9 CFR §§121.5 and 121.6, and 7 CFR §331.5. #### Regulation .03 Definitions. *COMAR 10.10.11.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Access” means the ability or the means necessary to: (a) Read, write, modify, or communicate BAR information; or (b) Otherwise make use of any system resource related to BAR information. (2) “Access control” means a method of restricting access to a BAR information resource, allowing only an authorized individual access to the resource. (3) “Authentication” means the corroboration that a person is the one claimed. (4) “BAR” means the Department’s Biological Agents Registry. (5) BAR Information. (a) “BAR information” means information submitted to the BAR Program by a person required to report a biological agent under this chapter. (b) “BAR information” identifies: (i) A person in this State who possesses, maintains, transfers, or receives a biological agent; and (ii) The biological agents possessed, maintained, transferred, and received by a person in this State. (c) “BAR information” includes: (i) Information contained in any of the documents and records that the BAR Program collects, requests, maintains, processes, or stores; (ii) Information released by the BAR Program, a trusted partner, or a BAR information custodian; and (iii) Biological agent incident response plans submitted to a local jurisdiction as required by this chapter. (6) BAR Information Custodian. (a) “BAR information custodian” means an individual designated by a trusted partner and authorized by the Department in a trusted partner agreement to receive and maintain BAR information. (b) “BAR information custodian” may include: (i) A health officer or designee; (ii) An Emergency Management Director or designee; and (iii) Other alternately designated and authorized individuals with a legitimate need to know the BAR information as it relates to the performance of the person's duties. (7) “BAR Program” means the Department’s BAR Program within the Laboratories Administration’s Office of Laboratory Emergency Preparedness and Response. (8) “Biological agent” means: (a) A select agent or toxin listed in 42 CFR §§73.3 and 73.4, 7 CFR §331.3, and 9 CFR §§121.3 and 121.4; (b) A genetically modified microorganism or genetic element from an organism listed in 42 CFR §§73.3 and 73.4, 7 CFR §331.3, and 9 CFR §§121.3 and 121.4, shown to produce or encode for a factor associated with disease; or (c) A genetically modified microorganism or genetic element that contains nucleic acid sequences coding for a toxin listed in 42 CFR §§73.3 and 73.4, and 9 CFR §§121.3 and 121.4, or the toxin's subunits. (9) Biological Agent Incident. (a) “Biological agent incident” means a breach of containment or imminent threat of a breach of containment of a biological agent that poses an immediate threat to an individual's health and safety. (b) “Biological agent incident” includes any situation that may cause or potentially cause an exposure to or release of a biological agent, as set forth in Regulation .12B of this chapter. (10) “Biosafety Level (BSL)” means the level of work practices, facility design, and safety equipment to prevent transmission of biologic agents to workers, other individuals, and the environment, as defined in the BMBL. (11) “Biosafety Level-2 (BSL-2)” means the BSL used when: (a) Work is done with biological agents associated with human disease; and (b) The route of transmission is by: (i) Percutaneous injury; (ii) Ingestion; or (iii) Mucous membrane exposure. (12) “Biosafety Level-3 (BSL-3)” means the BSL used when: (a) Work is done with indigenous or exotic agents associated with a potentially serious or lethal human disease; and (b) The route of transmission is aerosol inhalation. (13) Biosafety Level-4 (BSL-4). (a) “BSL-4” means the BSL used when work is done with a dangerous and exotic biological agent that poses a high risk of life-threatening or lethal human disease that: (i) May be transmitted via the aerosol route; (ii) Has an unknown mode of transmission; or (iii) Has no available vaccine or therapy. (b) “BSL-4” includes the BSL used when the agent has a close or identical antigenic relationship to BSL-4 agents. (14) “BMBL” means the “Biosafety in Microbiological and Biomedical Laboratories”, which is incorporated by reference in Regulation .04 of this chapter. (15) “Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services. (16) “Compact Disc-Recordable (CD-R)” means a type of write once, read many compact disc format that allows one-time recording of digital information on the disc. (17) Contingency Plan. (a) “Contingency plan” means a plan for responding to an information system emergency. (b) “Contingency plan” includes: (i) Installing system information from backups; (ii) Preparing critical facilities that can be used to facilitate continuity of operations in the event of an emergency; and (iii) Recovering from a disaster. (18) “Decryption” means reversing the protective encryption algorithm process to make the previously unintelligible plaintext available for further processing as intelligible plaintext. (19) “Deficiency” means a documented lack of compliance with a standard or requirement of the BAR Program set forth in this chapter. (20) “Department” means the Maryland Department of Health. (21) “Emergency management director” means an individual appointed by the Governor of Maryland, who is directly responsible for the organization, administration, and operation of the local organization for emergency management in the local jurisdiction as set forth in Public Safety Article, §14-109, Annotated Code of Maryland. (22) Encryption. (a) “Encryption” means transforming confidential plaintext into ciphertext to protect it so that the data can be securely stored. (b) “Encryption” includes encrypting with an algorithm that combines plaintext with other values called keys, or ciphers, so the data becomes unintelligible. (23) “Etiologic” means disease causing. (24) “Exposure” means the condition of being subjected to a biological agent which may have a harmful effect. (25) “Facility” means a building or complex of buildings owned by the same person and located at a single mailing address. (26) “Genetic element” means a nucleic acid sequence shown to produce or encode for a factor associated with a disease, a toxin, or a toxin's subunits. (27) “Local jurisdiction” means a county of the State or Baltimore City. (28) “Maintaining a biological agent” means manipulating or holding a biological agent to sustain or enhance viability, infectivity, or toxicity. (29) “Maryland Institute for Emergency Medical Services Systems (MIEMSS)” means the unit established by Education Article, §13-503, Annotated Code of Maryland. (30) “MDE” means the Maryland Department of the Environment. (31) “MEMA” means the Maryland Emergency Management Agency. (32) Nature of a Biological Agent. (a) “Nature of a biological agent” means the term that describes the kind or type of material or organism the agent is. (b) “Nature of a biological agent” includes: (i) Toxin; (ii) Bacterium; (iii) Virus; (iv) Rickettsia; (v) Fungus; (vi) Allergen; (vii) Genetic element; or (viii) Any combination of §B(32)(b)(i)—(vii) of this regulation. (c) “Nature of a biological agent” does not include the name or identity of the biological agent. (33) Person. (a) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (b) “Person” includes State and federal units of government. (34) “Personal identification number (PIN)” means a number or code assigned to an individual and used to provide verification of identity. (35) “Personal protective equipment (PPE)” means the type of physical barrier equipment necessary to: (a) Protect an individual from contact with a biological agent; or (b) Prevent transmission of a biological agent. (36) “Possessing a biological agent” means handling, holding, maintaining, owning, or storing a biological agent within the State. (37) Responsible Official. (a) “Responsible official” means an individual designated by a person required to report under this chapter to act on the person's behalf. (b) “Responsible official” includes an individual designated as an alternate responsible official who acts in the responsible official's absence. (38) “Role-based access” means a security mechanism for granting user access to a computer information system containing BAR information, based upon the user's job function. (39) “Secretary” means the Secretary of Health. (40) “Security incident” means a situation when BAR information is: (a) Intentionally or unintentionally released to an unauthorized person; or (b) Otherwise compromised in a way that allows unauthorized access. (41) Security Self-Assessment. (a) “Security self-assessment” means a person's formal assessment of the sensitivity, vulnerabilities, and security of the person's operations and programs related to the BAR information the person receives, manipulates, stores, or transmits. (b) “Security self-assessment” includes the: (i) Procedures and processes for determining a person's compliance with the BAR information security standards in this chapter; (ii) Documentation certifying to the BAR Program that a person meets the BAR information security standards; (iii) Identification and management of security risks; and (iv) Security standards self-assessment check list provided by the BAR Program. (42) “Technical security measure” means a process that is put in place to protect information and control individual access to information in order to guard data integrity, confidentiality, and availability. (43) “Token” means an electronic device for authenticating user identification and allowing access to a door or computer information system. (44) Toxin. (a) “Toxin” means a biologically active poisonous substance that is: (i) Produced by a living cell or an organism; and (ii) Harmful to another organism. (b) “Toxin” does not include: (i) A poisonous substance produced by a living organism for medical purposes, inactivated for use as a vaccine; or (ii) A toxin preparation for biomedical research use at a lethal dose of 50 percent (LD50) for vertebrates of more than 100 nanograms per kilogram body weight. (45) “Transfer” means the physical relocation of a biological agent from one facility or person to another. (46) Trusted Partner. (a) “Trusted partner” means a person with whom the Department has a valid trusted partner agreement to receive, possess, maintain, and transfer or share BAR information, as set forth in this chapter. (b) “Trusted partner” includes only MDE, MEMA, MIEMSS, and a local jurisdiction where a biological agent is located. (47) Trusted Partner Agreement. (a) “Trusted partner agreement” means a document describing the arrangement between the Department and a trusted partner regarding how, when, and to whom information is released from the BAR. (b) “Trusted partner agreement” includes the documentation that describes all the policies, procedures, and mechanisms agreed upon to protect the integrity, confidentiality, and availability of BAR information. (48) “User-based access” means a security mechanism used to grant system access to users, based upon the identity of the user. #### Regulation .04 Incorporation by Reference. *COMAR 10.10.11.04* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) 29 CFR §1910.1450, as amended. (2) 42 CFR 73, as amended. (3) 9 CFR 121, as amended. (4) 7 CFR 331, as amended. (5) CDC/NIH publication, “Biosafety in Microbiological and Biomedical Laboratories”, 5th Edition, December 2009, as amended. #### Regulation .05 Registering Under the Biological Agents Registry Program. *COMAR 10.10.11.05* A person in the State shall participate in and comply with the State's BAR Program by registering with and reporting to the Department, in the manner set forth in this chapter, the information required by the Department. #### Regulation .06 Compliance with Federal Standards. *COMAR 10.10.11.06* A person that possesses, maintains, transfers, or receives a biological agent shall comply with all safeguards contained in 42 CFR 73, 9 CFR 121, and 7 CFR 331 that apply to a person registered to transfer the same agent under federal law and regulation. #### Regulation .07 Responsibilities of the Department. *COMAR 10.10.11.07* The Department shall: A. Establish and maintain a registry that identifies the biological agents possessed, maintained, transferred, and received by a person in this State; B. Conduct facility surveys by mail, by on-site visit, or both, initially and periodically after that, to: (1) Ensure compliance with the standards and requirements of the BAR Program; and (2) Address any deficiencies or complaints; C. Provide or approve the forms that a person shall complete and submit to the Department under the BAR Program; D. Issue notice when a survey of a facility yields findings of deficiencies related to the standards or requirements of the BAR Program; E. Investigate a complaint that a facility or an employee is not complying with the standards or requirements of the BAR Program; and F. Release BAR information, as provided in this chapter, to: (1) State and federal law enforcement agencies; (2) CDC; (3) Trusted partners; and (4) The Secretary or designee. #### Regulation .08 Responsible Official; Alternate Responsible Official. *COMAR 10.10.11.08* A. A person required to report to the BAR Program under this chapter shall designate an individual to be the responsible official who: (1) Is familiar with the requirements of this chapter; (2) Has the authority and responsibility to act on the person's behalf related to a biological agent; and (3) Shall ensure compliance with the requirements of this chapter. B. The responsible person shall ensure that the annual inspection and specific reporting requirements and mechanisms are carried out in accordance with 42 CFR §73.9. C. A person required to report to the BAR Program under this chapter shall: (1) Designate one or more individuals to be an alternate responsible official to act in the responsible official's absence; and (2) Ensure that the individual designated as an alternate responsible official has the authority required in §A of this regulation to ensure compliance with this chapter when acting in the responsible official's absence. #### Regulation .09 Reporting Requirements. *COMAR 10.10.11.09* A. What to Report. Using reporting forms provided or approved by the Department, a person shall: (1) Identify all non-exempt biological agents that the person possesses, maintains, transfers, or receives listed under: (a) Select agents and toxins in: (i) 42 CFR §73.3; (ii) 9 CFR §121.3; and (iii) 7 CFR §331.3; and (b) Overlap select agents and toxins in: (i) 42 CFR §73.4; and (ii) 9 CFR §121.4; (2) Indicate as part of the identification if a biological agent is: (a) Viable or nonviable; (b) Purified genomic material; (c) Recombinant DNA; (d) Used in small or large animal work; (e) Used in large-scale production; and (f) A toxin; (3) Identify the physical location of a laboratory and storage area within a facility where a biological agent is contained; (4) Identify the biosafety level required for the biological agent; and (5) Identify the individual in charge of the biological agent and information needed to contact that individual. B. When to Report. A person shall: (1) Complete and submit a report within 30 days of receiving a request to report from the Department; (2) Submit a report of each transfer and receipt of a biological agent within 24 hours of completing a transfer as set forth in Regulation .10D of this chapter; (3) Respond in writing to a deficiency notice from the Department within 10 work days of receiving the notice; and (4) Respond in writing to notice of a complaint within 10 work days of receiving notice from the Department. C. Who Submits Reports. A person shall submit a report dated and signed by the: (1) Individual who actually possesses, maintains, transfers, or receives and has charge of a biological agent; and (2) Responsible official of the facility where the biological agent is located. D. Where to Report. A person shall return all completed reports and other correspondence to the BAR Program, c/o Laboratories Administration, Maryland Department of Health. #### Regulation .10 Additional Requirements Covering Possession, Maintenance, Transfer, or Receipt of a Biological Agent. *COMAR 10.10.11.10* A person possessing, maintaining, transferring, or receiving a biological agent at a facility located in the State shall: A. Possess a laboratory and personnel equipped and capable of handling the biological agents at BSL 2, 3, or 4, depending on the agent and the type of work being performed with the agent, as contained in the BMBL; B. Meet specific requirements for handling a toxin subject to this chapter as set forth in 29 CFR §1910.1450; C. Allow an official representative of the Department to determine compliance with the standards and requirements of this chapter by: (1) Conducting an on-site inspection of the person's facility, including all: (a) Storage areas; (b) Laboratories; and (c) Operations; and (2) Examining and reviewing procedures and documentation related to biological agents; D. Submit a copy of each completed CDC form documenting transfer or receipt of a biological agent, within 24 hours of completing a transfer or receipt, to the BAR Program; and E. Inform the Emergency Management Director or designee and health officer or designee in the local jurisdiction where the biological agent is located of the nature and facility location of each reported biological agent that is located in that jurisdiction. #### Regulation .11 Reporting of Unauthorized Activities. *COMAR 10.10.11.11* On learning that there is an unauthorized activity involving a biological agent, including the unauthorized possession, unauthorized attempted possession, unauthorized maintenance, unauthorized transfer, or unauthorized receipt of a biological agent, a person shall immediately alert the Department by: A. Telephoning the: (1) Laboratories Administration at 443-681-3787 or 410-925-3121 between 8 a.m. and 4:30 p.m. weekdays; or (2) Department's emergency after-hours and weekend telephone line at 410-795-7365 at other times; B. Asking the individual taking the call to direct the information being reported to the BAR Program or the Director of the Laboratories Administration; and C. Reporting details about the unauthorized activity set forth in this regulation, such as: (1) The location of a facility and laboratory involved; (2) The identity of a person possessing or attempting to possess a biological agent; and (3) Other details pertinent to the report. #### Regulation .12 Biological Agent Incident Response Plan. *COMAR 10.10.11.12* A. Requirement. A person required to report under this chapter shall: (1) Develop, implement, and maintain a written biological agent incident response plan; (2) Review the plan annually and revise the plan as necessary; and (3) Submit a copy of the plan and any amendments to the plan to the: (a) Emergency management director in the local jurisdiction where the biological agent is located; and (b) BAR Program. B. A person required to submit a biological agent incident response plan shall: (1) Coordinate the biological agent incident response plan with any facility-wide plans; (2) Keep the biological agent incident response plan current to reflect actual procedures and practices; (3) Locate and maintain the biological agent incident response plan in the workplace; (4) Make the biological agent incident response plan available to employees; (5) Ensure that the biological agent incident response plan fully describes the response procedures for: (a) The theft, loss, or release of a biological agent; (b) Inventory discrepancies; (c) Security breaches, including in computer information systems; (d) Severe weather and other natural disasters; (e) Workplace violence; (f) Bomb threats; (g) Suspicious packages; (h) Emergencies such as: (i) Fire; (ii) Gas leaks; (iii) Explosions; and (iv) Power outages; (i) Use of PPE; (j) Use of onsite emergency equipment to protect both the facility and personnel; (k) Employees to follow when performing: (i) Rescue or medical duties; (ii) Emergency medical treatment; and (iii) First aid; (l) Emergency evacuation, including: (i) Type of evacuation; (ii) Exit route assignments; (iii) Safe distances; and (iv) Places of refuge; (m) Decontamination; and (n) Site security and control; (6) Ensure that the plan includes procedures that explain the: (a) Risks and hazards associated with any biological agent on the premises; and (b) Actions to contain the biological agent; (7) Ensure that the plan contains the following information: (a) The name and contact information for home, work, and emergencies, for the: (i) Responsible official; and (ii) Alternate responsible official; (b) Where applicable, the name and contact information for: (i) The building owner and manager; (ii) Tenants; and (iii) The official in charge of the building's physical security; (c) Personnel roles and lines of authority and communication; (d) Planning and coordination with local emergency responders; and (e) A list of the PPE available and where the PPE is located in the facility; (8) Conduct drills or exercises at least annually to test and evaluate the effectiveness of the plan; (9) Notify the Emergency Management Director in the local jurisdiction where the biological agent is located and the BAR Program before a drill or exercise is conducted; (10) Notify the Emergency Management Director and the health officer in the local jurisdiction where the biological agent is located and the BAR Program immediately following a biological agent incident involving exposure or potential exposure as set forth in COMAR 10.06.01.03A; (11) Prepare a report of the results of a drill, exercise, or biological agent incident; (12) Review a report of the results of a drill, exercise, or biological incident to determine if the plan requires revision; and (13) Within 10 days after a drill, exercise, or biological agent incident, submit a copy of the report to the: (a) Emergency management director in the local jurisdiction where the biological agent is located; and (b) BAR Program. C. Monitoring Compliance. When a person submits a biological agent incident response plan to the BAR Program, the BAR Program shall verify that the person submitting the plan has provided the information for planning and coordinating with local emergency responders to the Emergency Management Director in the local jurisdiction where the biological agent is located. #### Regulation .13 BAR Information Confidentiality and Release of BAR Information. *COMAR 10.10.11.13* A. Except as otherwise provided in this chapter, a person shall keep information prepared for or maintained in the BAR, including biological agent incident response plans required by Regulation .12 of this chapter: (1) Confidential; and (2) Protected from unauthorized access and use. B. BAR information is not subject to State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland. C. Release or sharing of BAR information as authorized in this chapter does not render the BAR information released or shared a public record. D. Except as provided in §§G—I of this regulation, a person to whom BAR information has been released may not release the information to another person unless the release is approved by the BAR Program. E. The BAR Program may release BAR information only to: (1) State and federal law enforcement agencies; (2) CDC; (3) BAR information custodians of trusted partners; (4) The Secretary or designee; and (5) The health officer of any affected jurisdiction. F. Before the BAR Program releases BAR information to a person, except State and federal law enforcement agencies, the CDC, and the Department, the person shall: (1) Enter into and maintain a trusted partner agreement; (2) Conduct a BAR information security self-assessment; and (3) Submit the results of a BAR information security self-assessment to the BAR Program for approval. G. Mutual Aid Response. When multiple local jurisdictions respond to an emergency or biological agent incident, the Emergency Management Director of one responding jurisdiction may share BAR information with an Emergency Management Director from another local jurisdiction, and the health officer of one jurisdiction may share BAR information with the health officer of another jurisdiction that is providing mutual aid by assisting with the emergency response. H. Emergency Release Activation Process. (1) A trusted partner may release on an emergency basis BAR information about the nature and location of a biological agent to another trusted partner or emergency public safety personnel when: (a) An on-site alarm goes off at a person's facility where a biological agent is located and an individual at the site is required to place a telephone call to a 9-1-1 center; (b) A 9-1-1 center dispatches emergency public safety personnel to a site where a biological agent is known to be located; or (c) There is a reported breach of containment or imminent threat of a breach of containment of a biological agent that poses an immediate threat to the health and safety of the public or emergency public safety first responders. (2) MIEMSS may release on an emergency basis the nature and location of a biological agent to a: (a) Police officer, as defined in Public Safety Article, §3-201(e), Annotated Code of Maryland, who is responding to an emergency; and (b) Fire, rescue, or emergency medical services entity, as defined in Public Safety Article, §7-101, Annotated Code of Maryland, when responding to an emergency. I. 24/7 Access to BAR Information. (1) MDE, MEMA, and MIEMSS may act as a back-up to the BAR Program by maintaining: (a) 24/7 (24 hours a day, 7 days a week) access to BAR information; and (b) Access to BAR information when a trusted partner does not have access to BAR information. (2) MDE, MEMA, or MIEMSS may release BAR information regarding the nature and location of a biological agent to each other or another BAR Program trusted partner if the trusted partner is unable to obtain access to BAR information. J. Emergency Release of Name or Identity of a Biological Agent. MDE, MEMA, or MIEMSS may release by any necessary means of communication the name or identity of the specific biological agent located at the site of an emergency response to protect the health and safety of the public and emergency response personnel if: (1) There is: (a) A breach in containment of a biological agent; (b) An imminent threat of a breach of containment; or (c) An exposure or potential exposure; (2) The breach or imminent threat of a breach, exposure, or potential exposure is confirmed by the: (a) Responsible official; or (b) Emergency public safety personnel at the scene of the emergency response; (c) Occupational Health; and (3) The release is approved by the Department's physician on-call. K. Departmental Authorization to Release Name or Identity of Biological Agent. (1) The Department's physician on-call may release the name or identity of a biological agent as required to mitigate the risk and treat those exposed based on the potential threat to the health and safety of the public. (2) The Department's physician on-call shall decide when, how, and to whom to release the name or identity of the biological agent. L. Notification Protocol. (1) When there is a breach or imminent threat of a breach in containment of a biological agent, exposure, or potential exposure as described in §J of this regulation, the: (a) Responsible official or other designated person shall immediately notify the Emergency Management Director and health officer of any affected jurisdiction; (b) Public safety personnel responding to an emergency shall contact the public safety personnel's 9-1-1 center; and (c) 9-1-1 center personnel shall notify MIEMSS and each of the following individuals in the jurisdiction where the breach, exposure, or potential exposure occurred: (i) The Emergency Management Director; and (ii) The health officer. (2) When MIEMSS receives notice of a breach or an imminent threat of a breach of containment of a biological agent, exposure, or potential exposure, MIEMSS shall notify: (a) The Department's: (i) Physician on-call; and (ii) BAR Program within the Office of Laboratory Emergency Preparedness and Response; (b) MDE; (c) MEMA;and (d) The health officer of any affected jurisdiction. (3) Immediately after the health officer is notified by 9-1-1 center personnel, the health officer shall contact the Department’s physician on-call to: (a) Verify the BAR information release; and (b) Confirm a plan of action regarding: (i) Release of BAR information; and (ii) Measures to be taken to protect the health and safety of the public. M. Using a form provided by the BAR Program, a trusted partner shall notify the BAR Program within 72 hours after the: (1) Trusted partner's BAR information custodian releases or shares BAR information; or (2) Trusted partner releases or shares BAR information with another trusted partner. #### Regulation .14 Method of Non-Emergency Release of BAR Information. *COMAR 10.10.11.14* A. A person shall release and transfer BAR information to a trusted partner and a BAR information custodian in a secure manner, which includes the use of: (1) Read-only optical or electronic media; (2) Encryption, decryption, passwords, and firewalls; (3) Copy protection to prevent unauthorized copying or duplication. (4) A telephone; (5) Voice mail; (6) An electronic or mechanical recording device; and (7) An internet communication system, such as voice-over-internet-protocol (VoIP). B. The BAR Program shall release BAR information to a BAR information custodian of a local jurisdiction, MDE, MEMA, and MIEMSS: (1) When notified by the BAR Program that the BAR information is available for release; and (2) On weekdays between the hours of 8:30 a.m. and 3:30 p.m. C. BAR Program staff shall document the release of all BAR information to trusted partners in a permanent record that contains the: (1) Name of the BAR information custodian; (2) Identity of the trusted partner; (3) Means of release of BAR information, including but not limited to: (a) Encrypted email; and (b) CD-R; and (4) Date and time of the release or delivery of the BAR information. #### Regulation .15 Release of BAR Information to Law Enforcement Agencies and CDC. *COMAR 10.10.11.15* The BAR Program may release BAR information to State and federal law enforcement agencies and the CDC without a trusted partner agreement if the release of BAR information is pursuant to: A. A communicable disease investigation commenced or conducted by: (1) The Department; or (2) A State or federal law enforcement agency having investigative authority; or B. An investigation involving a release, theft, or loss of a biological agent. #### Regulation .16 Release of BAR Information to Local Jurisdictions. *COMAR 10.10.11.16* A. The Department shall release to a local jurisdiction the BAR information listed in §C of this regulation for each biological agent located within the local jurisdiction, if the local jurisdiction: (1) Enters into and maintains a trusted partner agreement with the Department; and (2) Limits the number of BAR information custodians in the local jurisdiction to the: (a) Health officer or the health officer’s designee; and (b) Emergency management director or the emergency management director’s designee. B. The local jurisdiction may use the BAR information for: (1) Protecting emergency first-responders, including: (a) Fire fighters; (b) Police officers; and (c) Emergency employees, including: (i) Emergency medical personnel; (ii) Rescue workers; and (iii) Public health emergency responders; (2) Planning for emergency protection of the public related to the: (a) Release of a biological agent; or (b) Prevention of a release of a biological agent; and (3) Conducting investigations related to biological agents. C. Information Released. The BAR Program shall inform the BAR information custodian in the local jurisdiction of the: (1) Location in the local jurisdiction of the biological agent, including the: (a) Facility or entity name; and (b) Physical address of the facility; (2) Nature of each biological agent; and (3) The BSL or PPE necessary to protect emergency responders from contact with or transmission of the biological agent. #### Regulation .17 Release of BAR Information to MDE, MEMA, and MIEMSS. *COMAR 10.10.11.17* The Department shall: A. Release separately to the BAR information custodians of MDE, MEMA, and MIEMSS the BAR information listed in §C of this regulation for each biological agent located within the State, if MDE, MEMA, and MIEMSS each separately becomes a trusted partner by: (1) Entering and maintaining a trusted partner agreement with the Department; and (2) Authorizing and identifying the individual who is the designated BAR information custodian in the trusted partner agreement; B. Make BAR information available to MDE, MEMA, and MIEMSS for the purpose of planning for the protection of the public related to the: (1) Release of a biological agent, such as a breach in containment; (2) Prevention of a release of a biological agent; and (3) Mitigation and planning for the protection of: (a) Critical infrastructure; (b) Key assets; and (c) Emergency public safety personnel; and C. Provide the following BAR information of each biological agent in the State that is registered under this chapter to the BAR information custodian of MDE, MEMA, and MIEMSS, including for the entity that possesses, maintains, transfers, or receives a biological agent: (1) Name and contact information of: (a) The responsible official; (b) The alternate responsible official; and (c) Other personnel or staff listed by the facility who are responsible for a biological agent; (2) Location of the biological agent, including the: (a) Facility or entity name; and (b) Physical address of the facility; (3) Name or identity of each biological agent; (4) Nature of each biological agent; (5) BSL necessary to handle safely and contain the biological agent; and (6) PPE necessary to protect emergency responders from contact with or transmission of the biological agent. #### Regulation .18 BAR Information Updates. *COMAR 10.10.11.18* The Department shall provide updated BAR information to the BAR information custodians of all trusted partners authorized under this chapter: A. Within 30 days when there is an: (1) Upward change in the BSL at a listed person's facility, for example from BSL-3 to BSL-4; or (2) Addition to the BAR, including a new: (a) Person possessing or maintaining a biological agent; (b) Facility where a biological agent is located; or (c) Biological agent; and B. At least once each year. #### Regulation .19 BAR Information Security Standards — General. *COMAR 10.10.11.19* A. A trusted partner shall protect and maintain BAR information in a secure manner by limiting access only to a BAR information custodian who is: (1) An individual designated by the trusted partner; and (2) Authorized by the Department in a trusted partner agreement. B. Before the Department shares BAR information with a trusted partner, the trusted partner shall: (1) Develop, implement, and maintain administrative, physical, and technical security measures and practices to protect and safeguard the integrity, confidentiality, and availability of BAR information by managing and supervising the: (a) Selection, execution, and use of security measures to protect BAR information; and (b) Conduct of personnel in relation to the protection of BAR information; (2) Assess potential risks and vulnerabilities to the BAR information in its possession using a BAR information security self-assessment checklist provided by the BAR Program; and (3) Submit a: (a) Completed BAR information security self-assessment; and (b) Document verifying that the trusted partner's BAR information custodian has successfully undergone a security risk assessment as described in 42 CFR §73.7. C. If a BAR information custodian believes that the security of BAR information has been or is suspected to have been misused, mishandled, lost, stolen, or otherwise compromised, the BAR information custodian shall immediately notify the: (1) BAR Program; and (2) Individuals who signed the BAR information custodian's trusted partner agreement. #### Regulation .20 BAR Information Security Standards — Administrative Procedures. *COMAR 10.10.11.20* A trusted partner shall establish and maintain administrative procedures to protect BAR information integrity, confidentiality, and availability, which include: A. Entering and maintaining with the Department a trusted partner agreement that certifies that the trusted partner shall: (1) Establish and implement the policies and procedures to carry out the requirements of this chapter; and (2) Designate a BAR information custodian; B. Establishing and implementing a contingency plan for protecting confidentiality of and access to BAR information when responding to a disaster or computer information system emergency, which includes: (1) Preparing critical facilities that can be used to facilitate continuing protection of BAR information in the event of an emergency; (2) Disaster recovery procedures to follow in the event of: (a) Fire; (b) Vandalism; (c) Natural disaster; or (d) Computer information system failure; (3) An emergency mode operation plan that includes procedures for assuring continuing protection of BAR information when the trusted partner continues to operate in the event of: (a) Fire; (b) Vandalism; (c) Natural disaster; or (d) Computer information system failure; and (4) Testing and revising procedures that document the process of periodically testing the written contingency plan procedures to determine: (a) Weaknesses; and (b) The subsequent process of revising the procedures, if necessary; C. A mechanism for the receipt, viewing, manipulation, storage, release, dissemination, and disposal of BAR information; D. Information-use policies that ensure that BAR information is used only as specified in this chapter; E. Internal audit procedures for: (1) Maintaining records of computer information system activity including: (a) Logons; (b) File accesses; and (c) Security incidents; and (2) Reviewing the records of computer information system activity for: (a) Breaches in security; and (b) Unauthorized access; F. Personnel security procedures that ensure that only personnel who have the required authorizations and agency clearances have access to BAR information by: (1) Providing oversight of unauthorized personnel when the personnel are performing their duties near BAR information, which includes: (a) Supervision of maintenance personnel by an authorized and knowledgeable individual; and (b) Assuring that unauthorized or unsupervised operating and maintenance personnel do not have and cannot acquire access to BAR information; (2) Maintaining and reviewing a record of access authorizations that documents the levels of access granted to an individual accessing BAR information; (3) Establishing personnel clearance procedures as a protective measure applied to determine that an individual's access to BAR information is permissible; and (4) Ensuring that BAR information computer information system users, including maintenance personnel, receive security awareness training; G. Employee termination procedures for ending an employee's employment or a user's access to BAR information, which includes: (1) Changing locks, lock combinations, or keypad codes when personnel knowledgeable of locks, lock combinations, or keypad codes no longer need to: (a) Know the information; or (b) Access BAR information; (2) Removal from access lists, including physical eradication of an individual's access privileges; (3) Termination or deletion of an individual's access privileges to BAR information for which the individual currently has authorization and need-to-know access when the authorization and need-to-know access no longer exists; and (4) Returning to the trusted partner any access devices, such as: (a) Keys; (b) Tokens; (c) Badges; or (d) Cards; and H. Training for all personnel concerning the vulnerabilities of the BAR information and ways to ensure the protection of BAR information, which include: (1) Awareness training including: (a) Password maintenance; (b) Security incident reporting; and (c) Viruses and other forms of malicious software; (2) Periodic security reminders of security concerns; and (3) User education in: (a) What to do if a virus is detected; (b) Monitoring logon success or failure; (c) How to report discrepancies; and (d) Password management, including the: (i) Rules to be followed in creating and changing passwords; and (ii) Need to keep passwords confidential. #### Regulation .21 BAR Information Security — Physical Safeguards. *COMAR 10.10.11.21* A trusted partner shall establish physical safeguards to guard BAR information integrity, confidentiality, and availability, which include: A. Physical protection of the personal computer system used for viewing BAR information and related buildings and equipment from: (1) Fire; (2) Natural and environmental hazards; (3) Disasters; and (4) Intrusion; B. A secure work station location with physical safeguards to eliminate or minimize the possibility of unauthorized access to BAR information, including: (1) Locating a personal computer used to access and view BAR information in a locked room; (2) Restricting access to the locked room to authorized personnel by using: (a) Electronic keypads; (b) Electronic access badges; or (c) Door locks; (3) Placing the computer monitor in a way that screen contents are not viewable by an unauthorized person; (4) Locking file cabinets, desks, and desk drawers that contain BAR information: (a) During nonworking hours; and (b) When the BAR information custodian is not present in the immediate area; and (5) Making BAR information nonviewable or unobtainable before admitting an unauthorized person into the workspace; C. BAR information media control procedures that govern the receipt, removal, and disposal of BAR information CD-R discs or thumb drives into or out of the facility, which include: (1) Access control so that only the BAR information custodian can receive the BAR information media; (2) Accountability procedures that trace the receipt, removal, and disposal of BAR information media; (3) BAR information storage; and (4) Tracking the disposal process and the final disposition of: (a) Electronic BAR information; and (b) BAR information hardware on which electronic BAR information is stored; D. Emergency mode operation access controls that enable continuing protection to BAR information in the event of: (1) Fire; (2) Vandalism; (3) Natural disaster; or (4) BAR information computer information system failure; E. A facility security plan to safeguard BAR information on the premises from unauthorized physical access, tampering, and theft; F. Verifying access authorizations before granting physical access; G. Maintaining documentation of repairs and modifications to the physical components of the facility including: (1) Hardware; (2) Walls; (3) Doors; and (4) Locks; and H. Procedures governing the reception and hosting of visitors, including: (1) Sign-in logs for visitors; and (2) Providing escorts for visitors, if appropriate. #### Regulation .22 BAR Information Security — Technical Security Measures. *COMAR 10.10.11.22* A trusted partner shall establish a system of technical security measures to protect BAR information integrity, confidentiality, and availability, which include: A. A BAR information security assessment to determine the sensitivity, vulnerabilities, and security of the trusted partner's programs and operations related to the BAR information the trusted partner: (1) Receives; (2) Views; (3) Manipulates; (4) Stores; or (5) Transmits; B. An information system certification based on a technical evaluation as part of and in support of the security process, which establishes the extent to which the trusted partner's computer system used for BAR information meets the security requirements of this chapter; C. Establishing and utilizing procedures and processes to guard against unauthorized access to BAR information by using: (1) Access controls that include: (a) Emergency role-based access of BAR information that documents the instructions for obtaining BAR information during a crisis; (b) User-based access; and (c) The use of encryption and decryption; (2) An alarm that can sense an unauthorized access within the computer system and produce a signaled response such as a: (a) System closure; (b) Time-phased automatic shutdown and restart cycle; or (c) Screen indicating a multiple password failure lockout; (3) Audit controls that record and examine system activity; (4) Audit trails of the use of and access to BAR information collected and used to facilitate a security audit; and (5) Event reporting that shows a screen message indicating an unauthorized request for BAR information access. D. Establishing procedures and processes for computer system authorization control for an individual to obtain access for the use and disclosure of BAR information, which include: (1) Role-based access; (2) User-based access; (3) BAR information authentication that corroborates that BAR information has not been altered or destroyed in an unauthorized manner by using a: (a) Message authentication code; or (b) Digital signature; (4) BAR information custodian authentication that includes: (a) Automatic logoff that causes an electronic session to terminate after a predetermined time of inactivity; and (b) A unique user identifier: (i) Made up of a combination alpha and numeric characters; and (ii) Maintained in security procedures for identifying and tracking individual user identity; and (5) A logon mechanism using a: (a) Password; (b) Personal identification number (PIN); (c) Token; or (d) Any combination of §D(5)(a)—(c) of this regulation; E. A security configuration management plan that includes: (1) A written security plan documenting the rules, procedures, and instructions concerning all components related to BAR information security; (2) Hardware and software installation and maintenance reviews; (3) Security testing to ensure that the selected security features are: (a) Implemented as designed; and (b) Adequate for the operational environment; and (4) Virus checking on a routine and regular basis; F. Security incident procedures that describe how to: (1) Report security incidents and breaches; and (2) Respond to and take action as a result of the receipt of a security incident report; and G. Sanction policies and procedures describing the disciplinary actions and notice of possible civil or criminal penalties an individual may be subject to for misuse or misappropriation of BAR information. #### Regulation .23 Trusted Partner Agreement. *COMAR 10.10.11.23* A. Requirement. The Department may not share BAR information with a person until the person becomes a trusted partner by entering into a trusted partner agreement, using the form developed by the Department. B. The Department shall develop and use a trusted partner form that contains, as applicable, separate clauses that: (1) Establish the length of time that the trusted partner agreement is in effect; (2) Address that confidentiality will survive the termination, expiration, or cancellation of the trusted partner agreement and state that the trusted partner: (a) May not use BAR information in a way that is detrimental to the Department; (b) Shall keep BAR information confidential; (c) Shall limit disclosure of BAR information only: (i) To individuals with a legitimate need in performance of the individuals' duties; and (ii) On a need-to-know basis as prescribed by this chapter; and (d) Shall employ security policies that: (i) Protect the confidentiality of BAR information; and (ii) Prevent improper disclosures or access to BAR information; (3) Require the trusted partner to notify the Department whenever the trusted partner discloses BAR information as allowed by this chapter; (4) Warrant and represent that the trusted partner is in compliance with all applicable State and federal laws and regulations regarding BAR information; (5) Require the trusted partner to execute a trusted partner agreement that upholds the standards and requirements in the trusted partner agreement that the trusted partner has with the Department; (6) Require the trusted partner to notify the Department when there is: (a) An improper or unauthorized: (i) Disclosure of BAR information; or (ii) Access to BAR information; (b) A misuse of BAR information; (c) A computer information system compromise that affects BAR information; or (d) An authorized release of BAR information as set forth in this chapter; (7) Address corrective action by stating: (a) The steps necessary to prevent any further unauthorized disclosure and misuse of BAR information; (b) That the trusted partner shall maintain an incident log of all unauthorized disclosures and misuse of BAR information; and (c) That the trusted partner shall send a copy of incident log entries to the BAR Program; (8) Require the trusted partner to: (a) Return the BAR information that was provided to the trusted partner; and (b) Exercise due diligence to destroy all material based on BAR information in a manner that renders nonidentifiable all documents, memoranda, notes, or other writings created or prepared by or for the trusted partner or BAR information custodian; (9) Require the trusted partner to make available on demand to the Department all policies and procedures relevant to safeguarding BAR information; (10) Address the authority of the individuals signing the trusted partner agreement that state that: (a) The individuals signing the trusted partner agreement have the right and authority to execute the agreement on behalf of their respective entity; and (b) No further approvals are necessary to make the trusted partner agreement binding; (11) State that the trusted partner agreement is the entire agreement between the Department and the trusted partner; (12) State that the trusted partner agreement may not be amended, except as agreed to by the Department in writing; (13) State that no provision or clause in the trusted partner agreement may be waived unless approved in writing by the Department; (14) Identify the individual designated by the trusted partner and authorized by the Department to receive, maintain, and if provided by this chapter, release BAR information; (15) Attest that the BAR information custodian has the trusted partner's agency clearance to receive BAR information; (16) Address a trusted partner's security policy that states the: (a) Value of BAR information; (b) Protection responsibilities; and (c) Organizational commitment for a system to protect the integrity, confidentiality, and availability of BAR information; and (17) State that if a provision, section, subsection, sentence, clause, or phrase of the trusted partner agreement is held invalid, the remaining portions of the trusted partner agreement remain valid. #### Regulation .24 Penalties. *COMAR 10.10.11.24* A. Fine. A person who violates a provision of Health-General Article, Title 17, Subtitle 6, Annotated Code of Maryland, or this chapter is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100 for the first offense and not exceeding $500 for each subsequent conviction for a violation of the same provision. B. Subsequent Offense. Each day a violation is continued after the first conviction is a subsequent offense. ### Chapter 12 — Medical Laboratories — Public Health HIV Testing Programs **Authority:** Health-General Article, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); adopted permanently effective March 14, 2005 (32:5 Md. R. 580) **Administrative History:** Regulation .01A, B amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .02B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .03 amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .04 amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .04D amended effective March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .04E amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .06D, E amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .07B amended effective April 1, 2013 (40:6 Md. R. 473); March 1, 2026 (52:24 Md. R. 1198) **Administrative History:** Regulation .09 amended effective April 1, 2013 (40:6 Md. R. 473) **Administrative History:** Regulation .10 amended effective April 1, 2013 (40:6 Md. R. 473) #### Regulation .01 Scope. *COMAR 10.10.12.01* A. This chapter sets the standards and requirements for a person to obtain and maintain a public health testing license to operate a public health testing program to perform rapid HIV antibody testing and rapid hepatitis C virus testing. B. This chapter applies to public health testing programs approved by the Secretary to conduct rapid HIV antibody testing and rapid hepatitis C virus testing. C. This chapter does not apply to any other type of laboratory testing entity such as a: (1) Point-of-care laboratory; (2) Commercial reference laboratory; (3) Hospital; or (4) Physician office laboratory. #### Regulation .02 Definitions. *COMAR 10.10.12.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “CDC” means the federal Centers for Disease Control and Prevention. (2) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988. (3) “Department” means the Maryland Department of Health. (4) “Primary standard” means a general comprehensive standard or set of standards as defined in COMAR 10.10.01.03B. (5) “Public health testing program” means a medical laboratory as defined in COMAR 10.10.01.03B that is affiliated or collaborating with the Department for the purpose of offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing approved by the Secretary. (6) “Public health testing license” means a license as defined in COMAR 10.10.01.03B issued by the Secretary authorizing the director of a public health HIV or hepatitis C (HCV) testing program to offer or perform rapid HIV tests or rapid hepatitis C virus tests. (7) Quality Assessment Plan. (a) “Quality assessment plan” means a planned system of step-by-step activities to ensure that: (i) Testing is being carried out according to the manufacturer's instructions; (ii) Results are accurate and reliable; and (iii) Problems and mistakes are found and corrected to avoid adverse outcomes. (b) “Quality assessment plan” includes the ongoing activities that monitor, review, evaluate, and improve the overall quality of the procedures and processes before, during, and after a test is performed. (8) Quality Control. (a) “Quality control” means the policies and procedures defined in COMAR 10.10.01.03B that monitor and evaluate the analytical or test performance phase of the testing process. (b) “Quality control” includes the operational techniques, tasks, or activities used to find and correct problems that might occur in the test system. (8-1) “Rapid hepatitis C virus test” means a public health hepatitis test that: (a) Uses whole blood as the specimen to detect hepatitis C antibodies; (b) Is waived under the CLIA program; and (c) Provides a test result while the individual being tested is waiting. (9) “Rapid HIV antibody test” means a public health HIV test that: (a) Uses whole blood or oral fluid as the specimen to detect HIV antibodies; (b) Is waived under the CLIA program; and (c) Provides a test result while the individual being tested is waiting. (10) “Secretary” means the Secretary of Health. #### Regulation .03 Incorporation by Reference. *COMAR 10.10.12.03* In this chapter, the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988 (2007)” is incorporated by reference. #### Regulation .04 Public Health Testing License for Rapid HIV Antibody Testing and HCV Testing. *COMAR 10.10.12.04* A. A person shall obtain a public health testing license before offering or performing rapid HIV antibody testing or rapid hepatitis C virus testing. B. A person may not: (1) Offer or perform rapid HIV antibody testing or hepatitis C virus testing without obtaining a public health testing license issued under this chapter; or (2) Transfer the public health testing license to another person. C. The Secretary may issue a public health testing license under this chapter if the Secretary determines that the public health testing program meets the requirements of this chapter. D. The Department shall issue a public health testing license that: (1) States that the license is limited to the performance of rapid HIV antibody testing and rapid hepatitis C virus testing; and (2) Lists the: (a) Name of the director; (b) Name of the public health testing program; and (c) Address of the public health testing program. E. To obtain, maintain, or renew a public health testing license, a person shall: (1) Make records and reports available to the Department; (2) Possess a valid CLIA Certificate of Waiver from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services; (3) Submit to the Department: (a) When seeking an initial license or license renewal, a quality assessment plan that describes the testing activities; (b) The location of all testing sites; and (c) The name and address of the laboratory that will perform confirmatory tests for the person operating the public health testing program; and (4) Submit amendments or changes to the public health testing program's quality assessment plan to the Department and obtain the Department's approval prior to implementation. F. The Department shall: (1) Review each submitted quality assessment plan to determine compliance with the requirements of this chapter; (2) Conduct on-site surveys of public health testing programs: (a) To investigate a complaint; and (b) Periodically to determine compliance with this chapter; and (3) Approve the plan for implementation by the public health testing program if the plan is in compliance with the requirements of this chapter. G. The Secretary may impose one or more sanctions as provided in COMAR 10.10.08.01—.03 if the Secretary determines that the public health testing program does not meet the standards of this chapter. #### Regulation .05 Quality Assessment Plan and Quality Control Requirements. *COMAR 10.10.12.05* A. Primary Standard. A person seeking or holding a public health testing license shall establish and maintain a quality assessment plan with written policies and procedures for monitoring and evaluating the operations and activities of the program. B. Quality Assessment Plan Components. A person seeking or holding a public health testing license shall ensure that the quality assessment plan addresses the operations and activities that occur before, during, and after testing and include the following components: (1) Verifying, before performing a test; that: (a) The testing process works as set forth in the manufacturer's test specifications and instructions; (b) Personnel are trained and competent to perform assigned tasks; (c) Procedures and logistics are in place for: (i) Performing a confirmatory test; (ii) Collecting a specimen for referral to a laboratory to perform a confirmatory test; or (iii) Referring an individual to a health care provider to have a confirmatory test performed; and (d) Biohazardous waste handling procedures are in place; (2) Troubleshooting procedures that: (a) Detect and resolve a problem that occurs during the testing process; (b) Require communication of a problem immediately to the director or appropriate supervisory personnel; (c) State when to discontinue testing; (d) Identify how to take corrective action in response to a problem; and (e) State how to: (i) Document a problem and the actions taken; and (ii) Verify that a corrective action taken has addressed the problem; (3) Procedures and mechanisms to maintain records that document: (a) Personnel training and competency; (b) Specimen referral and transfer; (c) Daily temperatures of the areas that will affect testing results; (d) Quality control test results that include the: (i) Results of the quality control test; (ii) Date and time the control testing was performed; (iii) Lot number and expiration of the test kit; (iv) Lot number and expiration date of the quality controls; and (v) Corrective actions taken if control results are invalid; and (e) Test result records for the individuals who are tested that include the: (i) Test result; (ii) Date and time testing was performed; (iii) Unique laboratory code for the individual being tested; (iv) Test kit lot number and expiration date; (v) Results of internal validity checks; (vi) Action taken if a result is invalid; (vii) Documentation of required confirmatory testing; (viii) Documentation when a specimen is sent for confirmation or the individual is referred for a confirmatory test; (ix) Confirmatory test results, when available; and (x) Identity of the individual who performed the test. #### Regulation .06 Personnel Training and Competency. *COMAR 10.10.12.06* A. Primary Standard. A person seeking or holding a public health testing license shall ensure that the personnel of the public health testing program are trained in how to perform assigned tasks and responsibilities. B. Personnel Training Components. A person seeking or holding a public health testing license shall ensure that personnel training includes the following components: (1) How to perform the test, including procedures performed before, during, and after testing; (2) How the testing is integrated into the overall counseling and testing program; (3) The components of the public health testing program's quality assessment plan; and (4) The use of bloodborne pathogen precautions and biohazard safety. C. Training Method. A person seeking or holding a public health testing license shall ensure that the public health testing program personnel training includes the following activities: (1) Reading the manufacturer's instructions for performing the test; (2) Observing a trained individual performing the test or viewing a video of a trained individual performing the test; (3) Practicing the performance of the test with positive and negative controls; (4) Practicing the specimen collection procedure; and (5) Reviewing the procedures and forms on how to document the testing. D. Personnel Competency. A supervisor or qualified trainer shall assess and document the competency of the public health testing program personnel for each task for which the individual is responsible: (1) Before the individual is permitted to perform testing without assistance for the first time; (2) Annually; and (3) When procedures or test systems are changed. E. A person seeking or holding a public health testing license shall have available and ensure that personnel follow the CDC “Quality Assurance Guidelines for Testing Using Rapid HIV Antibody Tests Waived Under the Clinical Laboratory Improvement Amendments of 1988” (2007). #### Regulation .07 Standard Operating Procedures Manual. *COMAR 10.10.12.07* A. Primary Standard. A person seeking or holding a public health testing license shall develop and maintain a standard operating procedures manual (SOPM) that is available to and followed by the public health testing program personnel. B. A person seeking or holding a public health testing license shall ensure that the SOPM includes the step-by-step instructions for the operations, tasks, and techniques occurring before, during, and after testing, including: (1) How to set up the testing site; (2) Use of quality assessment plan components, policies, and procedures; (3) The test manufacturer's product inserts and instructions; (4) Standard precautions for bloodborne pathogens; (5) Use of gloves and other personal protective equipment; (6) Handling and disposal of biohazardous waste; (7) How to provide testing information to an individual before the individual is tested; (8) How to counsel an individual receiving screening test results; and (9) How to refer an individual who has been tested for HIV antibodies or hepatitis C antibodies, or both, for services as prescribed in COMAR 10.18.08.10C. #### Regulation .08 Public Health Testing Program Director. *COMAR 10.10.12.08* A. Primary Standard. A person seeking or holding a public health testing license shall employ or otherwise engage the services of a director to oversee and manage the public health testing program. B. The director of a public health testing program shall oversee the planning, organization, direction, operation, and review of the program's operations, including: (1) Recruiting competent personnel; (2) Providing and documenting initial training and continuing education of program personnel; (3) Communicating and consulting with program personnel on a regular basis; (4) Conducting and documenting periodic on-site visits at the testing sites; (5) Maintaining the quality assessment plan; and (6) Ensuring that the program, testing site, and personnel meet applicable federal requirements and all standards and requirements set forth in this chapter. #### Regulation .09 Manufacturer's Requirements. *COMAR 10.10.12.09* A. Primary Standard. In addition to meeting the quality assessment plan requirements set forth in Regulation .05 of this chapter, a person seeking or holding a public health testing license shall ensure that public health testing program personnel meet the requirements and follow the manufacturer's test specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used. B. A person seeking or holding a public health testing license shall ensure that public health testing program personnel pay attention to the precautions and warnings set forth in the manufacturer's testing specifications and instructions for the rapid HIV test or rapid hepatitis virus C test being used for: (1) Product usage; (2) Test system and kit controls; and (3) The step-by-step instructions for performing the rapid HIV antibody test or rapid hepatitis C virus test. #### Regulation .10 Confirmatory Test. *COMAR 10.10.12.10* When an individual has a positive test result with the rapid HIV antibody test or rapid hepatitis C virus test, a person seeking or holding a public health testing license to offer or perform testing shall: A. Offer to perform a confirmatory test; B. Collect a specimen to refer to a laboratory to perform a confirmatory test; or C. Refer that individual to a health care provider to have a confirmatory test performed. ### Chapter 13 — Medical Laboratories — Testing for Hereditary and Congenital Disorders in Newborn Infants **Authority:** Health-General Article, §§13-101—13-103, 13-108—13-112, 13-601—13-605, 17-201—17-206, 17-210, 17-211, 17-215, and 17-216, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01— .27 adopted as an emergency provision effective January 1, 2009 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 490) **Administrative History:** Regulation .02A amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .03B amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .04B amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .06B amended as an emergency provision effective July 1, 2012 (39:15 Md. R. 962); amended permanently effective August 20, 2012 (39:16 Md. R. 1080) **Administrative History:** Regulation .06B amended effective April 27, 2015 (42:8 Md. R. 608); April 14, 2025 (52:7 Md. R. 321) **Administrative History:** Regulation .12 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .12C amended effective August 23, 2021 (48:17 Md. R. 669); April 14, 2025 (52:7 Md. R. 321); May 25, 2026 (53:10 Md. R. 454) **Administrative History:** Regulation .13 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .14 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .15 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .16 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .17 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .18B amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .20A, C amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .21 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .23 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .24A, D amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .25 amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .26A amended effective April 24, 2017 (44:8 Md. R. 404) **Administrative History:** Regulation .27C amended effective April 24, 2017 (44:8 Md. R. 404) #### Regulation .01 Purpose. *COMAR 10.10.13.01* A. This chapter, together with COMAR 10.52.12, establishes a coordinated Statewide system for the screening of newborn infants in the State for certain hereditary and congenital disorders associated with severe problems of health or development. B. This chapter also protects the public health by ensuring that accurate and reliable newborn screening and diagnostic test results are provided to a newborn infant's health care providers by requiring a medical laboratory performing screening tests, diagnostic tests, or both, on newborn infants for hereditary disorders, congenital disorders, or both, to: (1) Operate under reliable procedures and test methods; (2) Employ qualified personnel; (3) Establish and maintain reliable quality control and quality assurance programs; and (4) Interact effectively with components of the Department's coordinated Statewide Newborn Screening Program to identify newborn infants who may be at risk for a hereditary or congenital disorder. #### Regulation .02 Scope. *COMAR 10.10.13.02* This chapter: A. Identifies standards and requirements for a medical laboratory performing screening tests, diagnostic tests, or both, for hereditary and congenital disorders on blood-spot specimens from newborn infants; and B. Addresses the following newborn screening and diagnostic tests: (1) Screening tests, which are: (a) First-tier tests; and (b) Supplemental tests; and (2) Diagnostic tests, which are: (a) Second-tier tests; and (b) Supplemental tests. #### Regulation .03 Definitions. *COMAR 10.10.13.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Abnormal test result” means a first-tier, supplemental, or second-tier test result that: (a) Falls outside the normal range for the analyte measured; and (b) Triggers a request for additional testing or is diagnostic for a disorder. (2) Allele. (a) “Allele” means any one of a series of two or more different forms of a gene or DNA sequence that can exist at a single locus on a chromosome. (b) “Allele” includes the gene or DNA sequence for hemoglobin traits and disease states, such as hemoglobin S (HbS) for sickle cell disease. (3) “Analyte” means the substance or chemical constituent in blood being measured in a screening test used to detect the disorders listed in Regulation .12C of this chapter. (4) Birthing Facility. (a) “Birthing facility” means a facility that provides the antepartum, intrapartum, and postpartum management and care of women and their newborn infants. (b) “Birthing facility” includes a: (i) Birthing service that is licensed or accredited as a unit of a hospital; and (ii) Freestanding birthing center as defined in COMAR 10.05.02.01B. (5) Blood-Spot Specimen. (a) “Blood-spot specimen” means a whole-blood specimen collected from a newborn infant’s heel and applied to the designated area on a blood-spot collection test requisition card for the purpose of performing screening tests. (b) “Blood-spot specimen” includes: (i) The first screening blood-spot specimen collected from a newborn infant, usually in the birthing facility or other place where the newborn infant was born, within 48 hours after the newborn infant’s birth; (ii) The second screening blood-spot specimen collected from a newborn infant, usually collected when the newborn infant is between 10 and 14 days of age; and (iii) A blood-spot specimen collected subsequent to a blood-spot specimen specified in §B(5)(b)(i) and (ii) of this regulation as required to meet the medical needs and condition of the newborn infant and any additional specific screening blood-spot specimen collection and screening test requirements of this chapter and COMAR 10.52.12. (6) “Borderline result” means a screening test result that is at or near the established cut-off level for a particular analyte. (7) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988. (8) Congenital Disorder. (a) “Congenital disorder” means a significant structural or functional abnormality of the body that is present at birth. (b) “Congenital disorder” does not include a condition that results from: (i) An intrauterine infection; or (ii) A birth injury. (9) “Council” means the State Advisory Council on Hereditary and Congenital Disorders. (10) “Courier” means an entity employed by a person to convey a blood-spot specimen from the site of blood-spot specimen collection to the laboratory where the blood-spot specimen will be tested. (11) “Cut-off level” means a pre-determined, measurable value established for an analyte detected by a screening test, where that value is used to determine when a newborn infant's test result is normal, borderline, or abnormal. (12) “Department” means the Maryland Department of Health. (13) “Diagnostic test” means a test that is used to establish or confirm the presence of a: (a) Specific disease; or (b) Hereditary or congenital disorder. (14) “First screening” means a screening performed on the first blood-spot specimen collected from a newborn infant after birth. (15) “First–tier test” means a blood test performed on a newborn infant’s blood-spot specimen that: (a) Indicates the probable presence or absence of a hereditary or congenital disorder; or (b) Identifies a newborn infant who is at increased risk for a hereditary or congenital disorder. (16) “Follow-Up Unit” means the follow-up component and staff of the Department’s Newborn Screening Program, which carries out the duties set forth in COMAR 10.52.12.12. (17) Hereditary Disorder. (a) “Hereditary disorder” means a disorder that: (i) Is transmissible through the genetic material deoxyribonucleic acid (DNA); or (ii) Arises through the improper processing of information in the genetic material. (b) “Hereditary disorder” includes: (i) Hemoglobin disorders; (ii) Metabolic disorders; and (iii) Endocrine disorders. (18) “Home birth” means the birth of an infant which occurs intentionally outside of a birthing facility. (19) “Home birth attendant” means a physician who is licensed to practice under Health Occupations Article, Title 14, Annotated Code of Maryland, a nurse midwife who is licensed and certified under Health Occupations Article, Title 8, Annotated Code of Maryland, or a direct-entry midwife who is licensed under Health Occupations Article, Title 8, Subtitle 6C, Annotated Code of Maryland, who is caring for the mother and infant at delivery during a home birth as defined in §B(18) of this regulation. (20) “Metabolic Disorder” means a disorder caused by a genetic alteration that results in a defect in the function of a specific enzyme, hormone, or protein, which can be detected by: (a) Direct analysis of the enzyme, hormone, or protein; or (b) Testing for a substance whose metabolism is altered as a result of the defect. (21) “Newborn” or “newborn infant” means an infant: (a) Born in Maryland; (b) Born on federal property within Maryland; (c) Born outside of Maryland to parents whose residence is in Maryland; (d) From whom a blood-spot specimen was collected and submitted to the Department’s public health laboratory for newborn screening by a birthing facility or other health care provider located in Maryland, regardless of the infant’s place of birth; (e) Who has a screening test requested by the Follow-Up Unit: (i) For first-tier screening follow-up; (ii) For confirmation of a previous screening test result; or (iii) To assist with a newborn infant's diagnosis, therapy, or follow-up care; or (f) Who is in Maryland. (22) Newborn Screening or Screening. (a) “Newborn screening” or “screening” means one or more first-tier tests. (b) “Newborn screening” or “screening” includes: (i) First-tier testing on a first, second, or subsequent blood-spot specimen; and (ii) Supplemental first-tier testing. (23) Newborn Screening Program. (a) “Newborn Screening Program” means the Department's screening program for hereditary and congenital disorders, which performs operations and activities necessary to ensure that: (i) Newborn infants are given the opportunity to be tested; (ii) At risk newborn infants who are tested are identified and located; (iii) Newborn infants are given access to necessary follow-up testing; (iv) Diagnostic tests are available and the diagnosis is made or ruled out; and (v) Newborn infants diagnosed with a hereditary or congenital disorder are given access to treatment. (b) “Newborn Screening Program” includes: (i) The Department's public health laboratory as the sole screening laboratory; (ii) Another state's public health laboratory or a commercial laboratory that may serve the State as a screening laboratory during an emergency under a Departmental mutual aid agreement; (iii) Supplemental and second-tier testing performed by a state public health laboratory or by a permitted commercial or research laboratory; (iv) The Follow-Up Unit; and (v) The State Advisory Council on Hereditary and Congenital Disorders. (24) “Normal limit” means a measurable, numerical value or range that is considered not to indicate or establish the presence of a hereditary or congenital disorder. (25) “Permittee” means a person issued a permit by the Secretary to operate a medical laboratory as defined in COMAR 10.10.01.03B. (26) “Public health laboratory” means: (a) The Department's public health laboratory; and (b) Another state's public health laboratory or a commercial laboratory permitted in Maryland that is approved under a Departmental emergency mutual aid agreement to perform newborn screening tests on Maryland newborns. (27) Quality Assessment Plan. (a) “Quality assessment plan” means a planned system of step-by-step activities to ensure that: (i) Testing is carried out according to the manufacturer's instructions; (ii) Testing results are accurate and reliable; (iii) Testing problems and errors are found and corrected to avoid adverse health outcomes for newborn infants; and (iv) Testing results are reported and communicated in a timely manner as required by this chapter. (b) “Quality assessment plan” includes the ongoing activities that monitor, review, evaluate, and improve the overall quality of the procedures and processes before, during, and after a test is performed. (28) “Quality control” has the meaning stated in COMAR 10.10.06.03B. (29) Screening Test. (a) “Screening test” means a first-tier test used to detect a hereditary or congenital disorder listed in Regulation .12 of this chapter. (b) “Screening test” includes a test performed on a: (i) First screening blood-spot specimen; (ii) Second screening blood-spot specimen; or (iii) Subsequent screening blood-spot specimen. (c) “Screening test” does not include a: (i) Diagnostic test; or (ii) Second-tier test. (30) “Second screening” means a test performed on a routine second blood-spot specimen collected when the newborn infant is between 10 and 14 days old even though the test results from the newborn’s first blood-spot specimen were normal. (31) Second-Tier Test. (a) “Second-tier test” means a test performed on a newborn screening blood-spot specimen when a first-tier test provides an abnormal screening test result or a borderline abnormal screening test result. (b) “Second-tier test” includes a test that: (i) Establishes or confirms a newborn infant's risk for a hereditary or congenital disorder; (ii) Separates a newborn infant into a lower or higher risk category for a hereditary or congenital disorder; or (iii) Is diagnostic because it confirms the presence of a hereditary or congenital disorder. (32) “Secretary” means the Secretary of Health or the Secretary's designee. (33) “Supplemental test” means a test performed on a blood-spot specimen collected from a newborn infant that is: (a) Used to detect a hereditary or congenital disorder not specified in Regulation .12C of this chapter; or (b) Not required to be performed by the Department's public health laboratory under this chapter or COMAR 10.52.12. (34) “Unsatisfactory blood-spot specimen” means a blood-spot specimen that may produce an inaccurate or unreliable test result because the blood-spot specimen exhibits one of the problems of collection as specified in Regulation .21B and C of this chapter. #### Regulation .04 Permit. *COMAR 10.10.13.04* A. Eligibility. (1) Except as set forth in a Departmental mutual aid agreement, the Department's public health laboratory is the sole laboratory that may hold a State permit to perform and that may perform a first-tier newborn screening test on a newborn infant. (2) A medical laboratory other than the State's public health laboratory may obtain a permit to perform: (a) A supplemental test; (b) A second-tier test; or (c) Supplemental and second-tier tests. B. Requirements. Before offering to perform or performing a first-tier, supplemental, or second-tier test on a blood-spot specimen collected from a newborn infant, a person shall: (1) Obtain and maintain a valid: (a) Permit issued by the Secretary to operate a medical laboratory; and (b) CLIA Certificate from the U.S. Health and Human Services' Centers for Medicare and Medicaid Services; and (2) Meet applicable standards and requirements for: (a) A medical laboratory, as set forth in COMAR 10.10.01—.08; and (b) Testing for hereditary or congenital disorders in a newborn infant as set forth in this chapter. #### Regulation .05 Inspection Requirements. *COMAR 10.10.13.05* A. Inspection Authority. The Department may conduct on-site inspections of a permittee or applicant for a permit to perform supplemental or second-tier tests to screen for or diagnose congenital and hereditary disorders in newborn infants. B. Inspection Types. The Department may conduct the following types of inspections to assess compliance with the requirements of this subtitle and COMAR 10.52.12: (1) An initial inspection before issuing a permit; (2) A routine inspection during the permit period; and (3) An inspection subsequent to a complaint. #### Regulation .06 Fees. *COMAR 10.10.13.06* A. Permit Fees. A permittee or applicant for a permit that is not exempt under COMAR 10.10.04.01C, or that is not another state's public health laboratory approved to provide newborn screening tests under a Departmental mutual aid agreement, shall pay to the Department the applicable fees as required by COMAR 10.10.04 and this regulation. B. Screening and Follow-up Fee Requirement. A birthing center or person responsible for having newborn screening carried out for a newborn infant born outside a birthing facility shall pay a fee of $163.74 per newborn infant to the Department. C. Screening and Follow-Up Fee Payment. A birthing center or person responsible for having newborn screening carried out for a newborn infant born outside a birthing facility shall pay to the Department the total fees owed: (1) On a quarterly basis; and (2) Within 30 days of receiving an invoice from the Department. #### Regulation .07 Director Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.07* A. Director Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a director. B. Director Qualifications. The director shall: (1) Meet the qualifications for a medical laboratory director set forth at COMAR 10.10.07.04; and (2) Possess a current license as a laboratory director issued by the state in which the laboratory is located if: (a) The laboratory is not located in Maryland; and (b) Licensing is required by the state in which the laboratory is located. C. Director Responsibilities. The director is responsible for: (1) The overall operation and administration of the laboratory, including the employment of a sufficient number of competent personnel; (2) Ensuring that each first-tier, supplemental, or second-tier test conducted is performed accurately and reliably in all aspects of the testing process, including the preanalytic, analytic, and post-analytic phases of the total testing process; and (3) Ensuring compliance with: (a) This chapter; (b) The applicable parts of COMAR 10.10.01— 10.10.08; and (c) COMAR 10.52.12. #### Regulation .08 Technical Supervisor Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.08* A. Technical Supervisor Requirement. A permittee that offers to perform or performs a first-tier, supplemental, or second-tier test shall employ a technical supervisor. B. Director as Technical Supervisor. The director may function as the technical supervisor if the director meets the technical supervisor qualifications specified in this regulation. C. Technical Supervisor Qualifications. The technical supervisor shall meet the qualifications for a technical supervisor set forth at COMAR 10.10.07.05A(1) and B(7). D. Technical Supervisor Responsibilities. A technical supervisor shall be: (1) Responsible for the: (a) Technical and scientific methods used in the laboratory; and (b) Oversight of the laboratory; (2) Available to the laboratory personnel on an as-needed basis to provide supervision as specified in this chapter; and (3) Accessible to the laboratory to provide on-site, telephonic, or electronic consultation to laboratory personnel and clients. #### Regulation .09 Clinical Consultant Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.09* A. Clinical Consultant Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a clinical consultant. B. Director as Clinical Consultant. The director may function as the clinical consultant if the director meets the qualifications set forth under §C of this regulation. C. Clinical Consultant Qualifications. The clinical consultant shall be: (1) A doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy; and (2) Board certified by the American Board of Medical Genetics as a: (a) Clinical geneticist; (b) Medical geneticist; or (c) Biochemical geneticist. D. Clinical Consultant Responsibilities. A clinical consultant shall provide clinical consultation related to: (1) Inquiries concerning specific newborn screening tests; (2) Interpretation of specific test results; (3) Possible diagnostic or supplemental testing; and (4) Assistance in ensuring that appropriate tests are ordered to meet clinical expectations. #### Regulation .10 General Supervisor Requirement, Qualifications, and Responsibilities. *COMAR 10.10.13.10* A. General Supervisor Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ a general supervisor. B. General Supervisor Qualifications. The general supervisor shall: (1) Meet the qualifications for a general supervisor set forth at COMAR 10.10.07.06B(1); and (2) Have at least 6 months experience supervising the operation of applicable test systems, including: (a) Tandem mass spectrophotometry (MS/MS); (b) Time-resolved immunofluorometry; (c) Enzyme-linked immunosorbent assay (ELISA) systems; and (d) Isoelectric focusing and high-performance liquid chromatography. C. General Supervisor Responsibilities. A general supervisor shall carry out the responsibilities set forth in 42 CFR §493.1463, including: (1) Supervising the: (a) Day-to-day operation of the laboratory; and (b) Personnel performing tests and reporting test results; and (2) Being accessible to testing personnel at all times testing is performed to provide on-site, telephonic, or electronic consultation and resolve technical problems in accordance with policies and procedures established and approved by the director and technical supervisor. #### Regulation .11 Testing Personnel Requirement and Qualifications. *COMAR 10.10.13.11* A. Requirement. A permittee that offers to perform or performs first-tier, supplemental, or second-tier tests shall employ sufficient laboratory testing personnel to perform testing in accordance with the requirements of this chapter. B. Qualifications. Testing personnel shall meet the qualifications set forth at COMAR 10.10.07.07. #### Regulation .12 First-Tier, Supplemental, and Second-Tier Tests. *COMAR 10.10.13.12* A. First-Tier Tests; Requirement. The Department’s public health laboratory shall perform first-tier tests on all screening blood-spot specimens collected from a newborn infant. B. First-Tier Tests; Testing Limitations. (1) Only the Department's public health laboratory may screen for the disorders listed in §C of this regulation. (2) A permittee may perform a supplemental or a second-tier test only when the test is requested by an individual authorized to request a medical laboratory test as provided in COMAR 10.10.06.02. C. First-Tier Tests. The Department’s public health laboratory shall perform a first-tier test on a newborn infant to screen for the following hereditary and congenital disorders, which are approved for screening by the Council and the Secretary: (1) Biotinidase deficiency; (2) Congenital adrenal hyperplasia (CAH); (3) Hypothyroidism; (4) Galactosemia, galactose-1-phosphate uridyl transferase deficiency (GALT); (5) Epimerase Galactosemia, uridine diphosphate-galactose-4-epimerase deficiency (GALE); (6) Galactokinase Galactosemia, galactokinase deficiency (GALK1); (7) Sickle cell disease; (8) Sickle cell disease: S beta-thalessemia; (9) Sickle C disease: SC disease; (10) Other hemoglobin variants; (11) Phenylketonuria (PKU); (12) Hyperphenylalaninemia (Hyper-PHE); (13) Biopterin cofactor biosynthesis defects (BIOPT-BS); (14) Biopterin cofactor regeneration defects (BIOPT-REG); (15) Tyrosinemia, type I; (16) Tyrosinemia, type II; (17) Tyrosinemia, type III; (18) Homocystinuria; (19) Hypermethioninemia; (20) Branched chain ketoaciduria (BCK), also called maple syrup urine disease (MSUD); (21) Citrullinemia, type I; (22) Citrullinemia, type II; (23) Arginosuccinic aciduria; (24) Argininemia; (25) Methylmalonic acidemia, mutase deficiency (MMA); (26) Methylmalonic acidemia, adenosylcobalamin synthesis defects A and B (Cbl A, B); (27) Methylmalonic acidemia, adenosylcobalamin synthesis defects C and D (Cbl C, D); (28) Propionic acidemia (PA); (29) Isovaleric acidemia (IVA); (30) Glutaric aciduria type I (GA I); (31) 3-Hydroxy-3-methylglutaryl-CoA (HMG) lysase deficiency; (32) Isobutryl-CoA dehydrogenase (IBCD) deficiency; (33) 2-Methylbutyryl-CoA dehydrogenase deficiency (2MBG); (34) 3-Methlycrotonyl-CoA carboxylase deficiency (3MCC); (35) 3-Methlyglutaconyl-CoA hydratase deficiency (3MGA); (36) 2-Methyl-3-hydroxybutyrl-CoA dehydrogenase deficiency (2M3HBA); (37) Mitochondrial acetoacetyl-CoA thiolase (3-ketothiolase) deficiency (BKT); (38) Multiple carboxylase deficiency (MCD); (39) Malonic acidemia (MAL); (40) Medium chain acyl-CoA dehydrogenase deficiency (MCAD); (41) Medium chain ketoacyl-CoA thiolase deficiency (MCKAT); (42) Short chain acyl-CoA dehydrogenase deficiency (SCAD); (43) Short chain 3-hydroxy acyl Co-A dehydrogenase deficiency (SCHAD); (44) Very long chain acyl-CoA dehydrogenase deficiency (VLCAD); (45) 3-hydroxy long chain acyl-CoA dehydrogenase deficiency (LCHAD); (46) Multiple acyl-CoA dehydrogenase (MAD) or glutaric acidemia type II deficiency (GA II); (47) Carnitine/acylcarnitine translocase deficiency (translocase deficiency); (48) Carnitine palmitoyl transferase type I deficiency (CPT I); (49) Carnitine palmitoyl transferase type II deficiency (CPT II); (50) Carnitine uptake disorder; (51) Trifunctional protein deficiency (TFP); (52) 2,4-dienoyl-CoA reductase deficiency (DE RED); (53) Cystic fibrosis; (54) Severe combined immunodeficiency (SCID); (55) Pompe disease; (56) Fabry disease; (57) Spinal muscular atrophy (SMA); (58) Mucopolysaccharidosis type I (MPS I); (59) Mucopolysaccharidosis type II (MPS II); (60) X-linked Adrenoleukodystrophy (X-ALD); (61) Guanidinoacetate Methyltransferase Deficiency (GAMT); and (62) Infantile Krabbe Disease. D. Approved Methods: (1) A permittee shall use: (a) A colorimetric method for testing for a biotinidase deficiency, which is the disorder listed at §C(1) of this regulation; (b) A fluorometric method when testing for galactosemia, which is the disorder listed at §C(4)—(6) of this regulation; (c) A fluorescent-linked immunoassay method when testing for the hereditary or congenital disorders listed in §C(2) and (3) of this regulation; (d) Isoelectric focusing followed by high-performance liquid chromatography when testing for sickle cell disease, which is the disorder listed at §C(7)—(10) of this regulation; (e) Tandem mass-spectrometry when testing for the metabolic disorders listed in §C(11)—(52) of this regulation; (f) IRT/IRT (immunoreactive trypsinogen/immuno-reactive trypsinogen) when testing for cystic fibrosis, which is the disorder listed in §C(53) of this regulation; and (g) Real time polymerase chain reaction method when testing for severe combined immunodeficiency, which is listed in §C(54) of this regulation. (2) A permittee shall have 60 days from the amendment's effective date to comply with any amendment made by the Secretary to §D of this regulation. #### Regulation .13 Screening Test Blood-Spot Specimens — Collection and Test Requisition. *COMAR 10.10.13.13* A. Blood-Spot Specimen Collection. (1) A person shall collect a newborn infant’s blood-spot specimen for testing under this chapter by using only the special blood-spot specimen collection test requisition card provided by the Department. (2) The Department shall provide the special blood-spot specimen collection test requisition card to the: (a) Individual in charge of a birthing facility or the individual’s designated representative; or (b) Home birth attendant. (3) The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall collect a blood-spot specimen consisting of heel-stick whole blood obtained: (a) When a newborn infant is 24 to 48 hours old; (b) On a blood-spot specimen collection test requisition card provided by the Department; and (c) As set forth in Regulation .14 of this chapter. B. Blood-Spot Specimen Collection Test Requisition Card Information. An individual shall record the following information as specified on the Department-supplied blood-spot specimen collection test requisition card: (1) Newborn infant information, including: (a) Name; (b) Date of birth; (c) Time of birth; (d) Current weight; (e) Gender; (f) Race; (g) Gestational age; (h) Birthing facility identification, including the: (i) Facility name; (ii) Facility street address, city, state, and zip code; and (iii) Newborn infant's medical record or chart number; (i) Date and time of first feeding; (j) Type of feeding, such as: (i) Breast; (ii) Lactose-containing formula; or (iii) Formula containing no lactose; (k) Transfusion history, including transfusion date and time; (l) General health status of the newborn infant; and (m) The total protein and calorie intake for any newborn infant in a neonatal intensive care setting; (2) Blood-spot specimen information, including: (a) Date of collection; (b) Time of collection; and (c) Initials or other identifier of the individual who collected the blood-spot specimen; (3) Mother or guardian information, including: (a) Name; (b) Street address, city, state, and zip code; and (c) Telephone number where the mother or guardian may be reached; (4) Information on the pediatrician or attending physician who will be following the newborn infant, including the physician's: (a) Name; (b) Street address, city, state, and zip code; and (c) Telephone number; and (5) Other information that can affect the test results or the interpretation of the test results when applicable, such as that antibiotics were administered to the: (a) Mother; or (b) Newborn infant. #### Regulation .14 Screening Test Blood-Spot Specimens — Procedures, Submission, and Delivery Requirements. *COMAR 10.10.13.14* A. Standard Operating Procedure. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall maintain written standard operating procedures for the collection, handling, storage, and transport of newborn infant blood-spot specimen collection test requisition cards, including instructions for staff to: (1) Ensure and maintain blood-spot specimen integrity, quality, and acceptability; (2) Ensure proper: (a) Site preparation and cleaning; (b) Performance of the heel stick puncture; and (c) Application of whole blood to the collection test requisition card; (3) Identify precautions against: (a) Milking or squeezing the blood-spot specimen collection site; (b) Layering successive drops of blood on the same circle on the blood-spot specimen collection test requisition card; (c) Filling the circles on both sides of the filter paper; (d) Touching or smearing a blood-spot specimen before it is fully air-dried; (e) Scratching or abrading the blood-spot specimen; (f) Not allowing a blood-spot specimen to dry thoroughly before sending the blood-spot specimen collection test requisition card to a laboratory; and (g) Damaging, stretching, or wrinkling the filter paper before, during or after blood-spot specimen collection; (4) Recognize unsatisfactory blood-spot specimens; and (5) Handle and temporarily store a blood-spot specimen collection test requisition card, including the procedures and techniques for: (a) Drying blood-spot specimens; (b) Stacking of blood-spot specimen collection test requisition cards; and (c) Temporarily storing blood-spot specimen collection test requisition cards. B. Submission and Delivery Requirements. The individual in charge of a birthing facility or the individual’s designated representative, or the home birth attendant shall transport and deliver to the Department’s public health laboratory a newborn infant blood-spot specimen collection test requisition card using: (1) An employee or private courier; (2) A commercial carrier providing: (a) Overnight express delivery; or (b) Priority delivery; (3) A county or State operated courier system, where that service is available; or (4) A combination of §B(1)—(3) of this regulation. #### Regulation .15 Test Blood-Spot Specimens — Use, Research, Storage, and Retention. *COMAR 10.10.13.15* A. Use. A permittee may use a newborn infant blood-spot specimen from a newborn infant to test for only the conditions listed in Regulation .12C of this chapter. B. Research. A researcher may not use a Maryland newborn infant’s blood spot specimen or test results for research purposes unless the: (1) Research is approved in writing by the Department's: (a) Newborn Screening Program; and (b) Institutional Review Board; and (2) Researcher acknowledges in writing that the researcher will return all untested blood-spot specimens to the Department’s public health laboratory within 6 months of completing the approved research. C. Storage. A permittee or researcher shall store a newborn infant blood-spot specimen in a sealed, moisture-proof container at between 2ºC and 6ºC. D. Retention. (1) A permittee shall: (a) Retain a newborn infant’s gel, produced when testing for hemoglobin disorders, for at least 90 days after testing is complete; and (b) Return to the State’s public health laboratory all untested blood-spot specimens received from the Department’s public health laboratory for supplemental or diagnostic testing within 90 days after testing is completed by the permittee. (2) The Department’s public health laboratory shall retain and maintain for 25 years a newborn infant’s blood-spot specimen after the blood-spot specimen is received for screening, supplemental testing, or diagnostic testing. #### Regulation .16 Test Records — Retention. *COMAR 10.10.13.16* The Department’s public health laboratory shall retain and maintain electronically or as a hard copy for 25 years the: A. Top copy of the requisition portion of the blood-spot specimen collection test requisition card; B. All test results and reports; C. Electronic data bases; and D. Supporting documents that show how a reported test result was obtained and verified, including but not limited to: (1) Quality control records; (2) Instrument maintenance and repair records; (3) Test reagent records; and (4) Instrument and test system data. #### Regulation .17 Testing — First-Tier. *COMAR 10.10.13.17* A. The Department’s public health laboratory shall test, using first-tier tests, appropriately timed and collected blood-spot specimen of a newborn infant’s blood for the disorders listed in Regulation .12C of this chapter. B. Full-Term Healthy Newborn Infants. (1) If a newborn infant is born at term and is healthy, the Department’s public health laboratory shall conduct a: (a) First screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the full-term healthy newborn infant is between 24 and 48 hours old; and (b) Second screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between 10 and 14 days old. (2) If the first blood-spot specimen is collected when a full term healthy newborn infant is younger than 24 hours old, the Department’s public health laboratory shall conduct a: (a) Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter on a blood-spot specimen collected when the newborn infant is between 24 hours and 7 days old; and (b) Third screening using first-tier tests on a blood-spot specimen collected when the full-term healthy infant is between 1 and 4 weeks old. C. Premature or Ill Newborn Infant. (1) If a newborn infant who is born prematurely or expected to be ill for more than 14 days was younger than 24 hours old when the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct a: (a) Second screening using first-tier tests to detect the disorders listed in Regulation .12C of this chapter when the newborn infant is between 24 hours and 3 days old; and (b) Third screening using first-tier tests when the newborn infant is between 7 days and 14 days old to screen for: (i) Amino acid disorders as specified in Regulation .12C(11)—(24) of this chapter; (ii) Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter; (iii) Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter; and (iv) Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter. (2) If a newborn infant who is born prematurely or expected to be ill for more than 14 days was 24 hours old or older at the time the newborn infant’s blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall perform a second screening to screen for: (a) Amino acid disorders as specified in Regulation .12C(11)—(24) of this chapter; (b) Acylcarnitine disorders as specified in Regulation .12C(25)—(52) of this chapter; (c) Congenital hypothyroidism as specified in Regulation .12C(4) of this chapter; and (d) Severe combined immunodeficiency, as specified in Regulation .12C(54) of this chapter. (3) If a newborn infant was transfused before the blood-spot specimen was collected for a first screening, the Department’s public health laboratory shall conduct, in addition to any other screenings specified in §B(1) and (2) of this regulation, a fourth screening using first-tier tests on a blood-spot specimen collected 4 months after a newborn infant’s last transfusion to screen for: (a) Hemoglobin as specified in Regulation .12C(7)—(10) of this chapter; (b) Biotinidase as specified in Regulation .12C(1) of this chapter; and (c) Galactose-1-P-uridyl-1-transferase as specified in Regulation .12C(3) of this chapter. #### Regulation .18 Testing — Second-Tier and Supplemental. *COMAR 10.10.13.18* A. When a test request is made by an individual authorized to request a laboratory test, as set out in COMAR 10.10.06.02: (1) A permittee other than the Department's public health laboratory may perform a second-tier or supplemental test; and (2) The Department's public health laboratory may perform a second-tier test. B. A permittee: (1) May not contract out, subcontract, or otherwise transfer supplemental or second-tier testing to another laboratory that does not hold a Maryland permit in the discipline of diagnostic and supplemental testing for hereditary and congenital disorders in newborns; (2) Shall complete a second-tier or supplemental test on a blood-spot specimen within 3 working days after the blood-spot specimen arrives at the laboratory; and (3) Shall report the results of a second-tier or supplemental screening test as required in Regulations .23 and .24 of this chapter. #### Regulation .19 Proficiency and Competency Testing for Newborn Screening Tests. *COMAR 10.10.13.19* A permittee shall: A. Meet all requirements set forth in COMAR 10.10.05; B. Successfully participate in one or more approved proficiency testing programs that cover all first-tier, second-tier, and supplementary tests offered or performed; C. Evaluate and document performance, semiannually during the first year of testing and annually thereafter, of all individuals responsible for testing; and D. In addition to the proficiency testing requirement in §A of this regulation, participate in the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program. #### Regulation .20 Quality Control. *COMAR 10.10.13.20* A. Quality Control Program. (1) A permittee shall develop, establish, implement, maintain and follow written quality control policies, procedures, and techniques that provide and ensure accurate, reliable, and valid test results and reports. (2) A permittee's quality control program shall: (a) Cover all tests, methods, and procedures performed by the laboratory; and (b) Meet the standards and requirements set forth in this chapter and COMAR 10.10.06. (3) A permittee's quality control procedures and practices shall include, but are not limited to, the use of: (a) Analyses of reference materials to ensure the reproducibility and accuracy of test results; (b) Systems to ensure proper functioning of instruments, equipment, reagents, and performance of laboratory personnel; (c) Valid reagents, equipment, calibration, and systematic procedural checks; (d) A system that ensures timely and pertinent error detection and correction for the review and reporting of test results; and (e) Quality control materials from the Centers for Disease Control and Prevention's Newborn Screening Quality Assurance Program. B. Adequacy of Methods and Equipment. To ensure the adequacy of test methods, test systems, and equipment, a permittee shall: (1) Employ methods, test systems, and equipment that provide accurate and reliable test results and reports; (2) Have sufficient and suitable equipment and instruments to perform the type and volume of tests offered and performed by the laboratory; (3) Perform tests in a manner that provides accurate and reliable test results; (4) Monitor test methods, instruments, and testing systems, where applicable, for the following performance characteristics: (a) Method, instrument, and test system detection limits and cutoff levels; (b) Precision; (c) Accuracy; (d) Specificity; (e) Sensitivity; (f) Interferences; and (g) Other related test variables that affect test results; and (5) Have adequate quality control systems and procedures in place to: (a) Obtain and verify a statistically valid number of counts or measurement levels to give accurate and reliable test results for an analytical instrument, each day an instrument is used for testing; and (b) Report results: (i) As set forth in COMAR 10.10.06.04; (ii) As set forth in 42 CFR §493.1291; and (iii) Within the time frames required by this chapter. C. Supplies, Reagents, and Materials. (1) A permittee shall ensure that supplies, reagents, and other materials used in the collected, handling, testing, and storing of newborn blood-spot specimens are stored, labeled, checked for proper reactivity, and used according to the provisions of this chapter. (2) A permittee shall: (a) Label laboratory supplies and materials used in the testing process, including reagents, solutions, controls, and calibrators to indicate the: (i) Identity of reagents, solutions, controls, and calibrators; (ii) Strength or concentration; (iii) Storage requirements; (iv) Preparation and expiration date; (v) Identity of the preparer; and (vi) Other pertinent information that affects test performance; (b) Store laboratory materials in the manner recommended by the manufacturer; (c) Test representative samples of each lot of materials used for or in the process of testing blood-spot specimens on a regularly scheduled basis to determine that each lot of test material is capable of performing as required; and (d) Use supplies, reagents, kits, test systems, and other materials in a manner consistent with the recommendations and instructions provided by the manufacturer. (3) A permittee may not use supplies, reagents, kits, test systems, or other materials in the testing process that have: (a) Exceeded the materials' established expiration dates; (b) Substandard reactivity; or (c) Deteriorated. #### Regulation .21 Quality Assessment and Quality Assurance. *COMAR 10.10.13.21* A. A permittee shall: (1) Establish and follow a written quality assessment plan that covers all phases of the testing process; (2) Meet the applicable quality assurance requirements of COMAR 10.10.06; and (3) Have an accessioning mechanism or system that: (a) Tracks blood-spot specimens and allows first and subsequent blood-spot specimens and test results from the same newborn infant to be linked for testing and analysis; and (b) Identifies a specific analyte that requires retesting when a newborn infant's prior screening test results for that analyte are abnormal or border-line abnormal. B. A permittee may not test a blood-spot specimen exhibiting: (1) Blood that did not saturate the filter paper; (2) A circle containing no blood; (3) A blood clot or tissue on the surface of the blood; (4) A circle over-saturated with blood showing dark areas in the circle or at the perimeter; (5) Blood that appears layered or clotted; or (6) Serum rings or blood that appears diluted, discolored, or contaminated. C. A permittee may not test a blood-spot specimen: (1) Collected more than 10 days before the screening test is to be started; (2) That is unaccompanied by information necessary for the testing to be meaningful, including the: (a) Age of the newborn infant; (b) Identification of the newborn infant; (c) Date and time of blood-spot specimen collection; (d) Date and time of birth; (e) Newborn infant's weight; and (f) Date and time of a newborn infant's first feeding; (3) If an infant was transfused before the first screening and the repeat blood-spot specimen collected to test for hemoglobin was drawn earlier than 4 months after the last transfusion; or (4) If the newborn infant was younger than 24 hours old or the newborn's age was unknown at the time of collection and the requested screening test is for: (a) Congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter; or (b) Thyroxine or thyroid stimulating hormone as specified in Regulation .12C(4) of this chapter. D. Within 24 hours of receipt of an unsatisfactory blood-spot specimen, the permittee shall notify the submitter of the unsatisfactory blood-spot specimen by telephone, facsimile, or electronic mail: (1) That the blood-spot specimen cannot be tested; and (2) To submit another blood-spot specimen as soon as possible. E. If a permittee reports a test result on a newborn infant and later discovers that the test result was erroneous or questionable, the permittee shall: (1) Give prompt notice of the erroneous or questionable patient test result to the: (a) Person who requested that the test be performed; (b) Physician or other person to whom the laboratory has previously sent a report that contained the erroneous or questionable result; and (c) Follow-Up Unit; (2) Provide corrected reports to the persons notified in §E of this regulation; (3) Maintain duplicates of both the original report and the corrected report; (4) Conduct a quality assessment of all phases of the testing process to determine the cause of the erroneous or questionable test result; (5) Take the necessary remedial or corrective action to prevent recurrence of the problem; and (6) Take any additional measures necessary to reduce or eliminate the threat to the health and safety of the patient including: (a) Notifying a parent or guardian of the newborn infant of the erroneous or questionable result; (b) Retesting the same blood-spot specimen; (c) Testing a new blood-spot specimen; and (d) Retesting the same blood-spot specimen and testing a new blood-spot specimen. #### Regulation .22 Quality Assurance — Continuity of Operations and Disaster Recovery Plan. *COMAR 10.10.13.22* A permittee shall develop, implement, and maintain written continuity of operations and disaster recovery plans that ensure the continuous performance of essential functions and operations: A. During an emergency; or B. When the laboratory temporarily can no longer meet the requirements and standards set forth in this chapter. #### Regulation .23 Reporting Test Results. *COMAR 10.10.13.23* A. All Test Results. For a newborn infant, a permittee shall: (1) Report all first-tier, supplemental, and second-tier results to: (a) The person who requested the test; and (b) An individual who will use the test results in identifying, tracking, caring for, and treating the newborn infant, including: (i) A physician specialist; and (ii) Personnel in the Follow-Up Unit; (2) Report to the persons listed in §A(1) of this regulation within 3 working days after the laboratory obtains the blood-spot specimen, all test results that are within normal limits; (3) Report to a person requesting a second or subsequent screening the test results from the newborn infant's prior screening if not previously reported to the person; (4) Include with each report the following information: (a) Date the blood-spot specimen was received in the laboratory; (b) Date of the report; and (c) Cut-off level for each reported analyte; and (5) Report all abnormal test results to the Follow-Up Unit on the same day that a test result is obtained and reviewed. B. Specific Test results. A permittee may not report a test result as being within normal limits for: (1) Amino acid levels for disorders specified in Regulation .12C(11)—(24) of this chapter and for a total galactose level for galactosemia as specified in Regulation .12C(3) of this chapter if: (a) A newborn infant was not on milk or formula feeding at least 24 hours before the blood-spot specimen was collected; or (b) The time of milk or formula feeding is unknown; or (2) 17-hydroxy progesterone results for congenital adrenal hyperplasia as specified in Regulation .12C(2) of this chapter and thyroxine and thyroid stimulating hormone for hypothyroidism as specified in Regulation .12C(4) of this chapter if the blood-spot specimen was collected when the newborn infant was: (a) Younger than 24 hours old; or (b) Of unknown age. #### Regulation .24 Reporting Abnormal Test Results to the Follow-Up Unit. *COMAR 10.10.13.24* A. Reporting Requirements. A permittee shall immediately report an abnormal or diagnostic test result to the Follow-Up Unit by: (1) Telephoning and personally speaking to an individual in the Follow-Up Unit; (2) Telephoning and personally speaking to a back-up individual representing the Follow-Up Unit, if an attempt to make in-person contact with an employee of the Follow-Up Unit fails; and (3) Following up a telephonic report within 24 hours with a report by facsimile or electronic mail to the Follow-Up Unit. B. Verification Requirement. A permittee shall contact the Follow-Up Unit by telephone at least once every 6 months to ensure that the permittee is able to meet the requirements in §A of this regulation. C. Reporting Requirements; General. A permittee shall provide with each abnormal result, where applicable, the: (1) Identity or name of each analyte measured; (2) Measured numerical concentration or range of: (a) Each analyte measured; and (b) All related analytes measured; (3) Value of any relevant ratios used to determine abnormality; (4) Postnatal age of the newborn infant; (5) Appropriate gestational age/birth weight control range; (6) Cut-off level for the analyte of a hereditary or congenital disorder; and (7) Measure of the degree of abnormality of the test result. D. Reporting Requirements; Sickle Cell Disease Hemoglobin. A permittee shall report results for hemoglobin disorders as specified in Regulation .12C(7)—(10) of this chapter for sickle cell disease in terminology that includes: (1) The alleles present in decreasing quantitative order; and (2) Specifying trait states and possible disease states for at least the following alleles: (a) Hemoglobin C; (b) Hemoglobin D; (c) Hemoglobin E; (d) Hemoglobin G; (e) Hemoglobin O; and (f) Hemoglobin S. #### Regulation .25 Reporting System and Communication Software. *COMAR 10.10.13.25* A permittee shall: A. Have available and use a reliable and accurate electronic information system that is capable of collecting, compiling, transferring, and communicating all normal and abnormal test results to the Follow-Up Unit; and B. Provide the Follow-Up Unit, where applicable, with: (1) The necessary information system and electronic communications software or interface to be used by the Follow-Up Unit to receive from the permittee the newborn screening test results and reports required in this chapter; and (2) Software programming assistance to ensure that the: (a) Permittee's data transmitted to the Follow-Up Unit is accurate and timely; and (b) The Follow-Up Unit's information system maintains compatibility with the permittee's information system. #### Regulation .26 Availability of Statistical and Scientific Data. *COMAR 10.10.13.26* A. Statistical Reports. The State’s public health laboratory, the Follow-Up Unit, or both, on request, shall provide Newborn Screening Program statistical data for official State and national reports to: (1) The Council; (2) The Department's Office of Genetics and Children with Special Healthcare Needs; and (3) State and federal agencies that use test results and statistics for the care and treatment of newborn infants. B. Research Investigations. The Laboratories Administration, the Follow-Up Unit, or both, may participate in research investigations approved by the Department's Institutional Review Board. #### Regulation .27 Sanctions. *COMAR 10.10.13.27* A. Due to the life-threatening nature and effect of errors in newborn screening testing, the Secretary may order summarily the suspension of a permit if the Secretary finds that the public health, safety, or welfare imperatively requires emergency action, including but not limited to, if a permittee has: (1) Failed to report a newborn infant's abnormal test result as required in this chapter; (2) Falsified a document submitted to the Department, including but not limited to a: (a) Newborn infant screening test report; or (b) Quality control or quality assurance report; or (3) Failed to provide a corrected or amended test report if the permittee has reported an erroneous or questionable test result. B. If the Secretary summarily suspends a permit as provided in §A of this regulation, the Secretary shall promptly give the permittee: (1) Written notice of the suspension, the finding, and the reasons that support the finding; and (2) An opportunity to be heard. C. The Secretary may impose a directed plan of correction, limit testing, deny a permit renewal, or suspend or revoke a current permit if a permittee has: (1) Failed to meet the applicable standards and requirements set forth in: (a) Health-General Article, Title 17, Annotated Code of Maryland; or (b) COMAR 10.10.01—.08 and this chapter; (2) Conducted research on newborn infant blood-spot specimens within the Newborn Screening Program’s approval as required in Regulation .15 of this chapter; or (3) Failed to pay the Department any fee required under this subtitle. D. In addition to sanctions provided in §§A and C of this regulation, the Secretary may: (1) Impose any sanction provided in COMAR 10.10.08; and (2) Refer a person for criminal prosecution, as provided at Health-General Article, §17-216, Annotated Code of Maryland. E. A person may have a hearing on the imposition of a sanction and an opportunity to respond to a sanction imposed by the Secretary under this regulation as set forth in COMAR 10.10.08.03. F. Except as provided in §§A and B of this regulation, before the Secretary denies, suspends, or revokes a permit, the Secretary shall give the applicant or permittee notice of the action and an opportunity to be heard. ## Subtitle 11 — Maternal and Child Health ### Chapter 01 — Identification of Infants **Authority:** Health-General Article, §§2-104(b), 20-401, and 20-402, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Subtitle 11 Midwifery effective February 1, 1957; repealed effective July 12, 1987 (14:14 Md. R. 1572) **Administrative History:** Regulations .01—.03 adopted effective December 25, 1989 (16:25 Md. R. 2710) **Administrative History:** Chapter revised effective April 6, 2009 (36:7 Md. R. 524) **Administrative History:** Regulation .02 amended effective March 30, 2026 (53:6 Md. R. 291) #### Regulation .01 Scope. *COMAR 10.11.01.01* These regulations affect all institutions or related facilities, as defined in Regulation .02 of this chapter, that deliver a newborn infant from its mother. #### Regulation .02 Definitions. *COMAR 10.11.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Born” means the complete expulsion or extraction of a product of human conception from its mother, regardless of the period of gestation, if, after the expulsion or extraction, it breathes or shows any other evidence of life, such as heartbeat, pulsation of the umbilical cord, or definite movement of voluntary muscle, whether or not the umbilical cord is cut or the placenta is attached. (2) “Cord blood sampling” means the taking of a sample of a newborn infant's blood from the infant's umbilical cord. (3) “Footprinting” means the taking of an ink or other type of impression of the skin patterns located on the sole of the newborn infant's foot. (4) “Institution” means: (a) A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland; (b) A freestanding birthing center as defined in Health-General Article, §19-1101, Annotated Code of Maryland; or (c) Any other facility that delivers an infant from its mother. (5) “Secretary” means the Secretary of Health or the Secretary's designee. #### Regulation .03 Identification of Newborn Infants — Mandatory Procedure. *COMAR 10.11.01.03* A. An institution shall perform the infant identification procedures described in this regulation: (1) Immediately after the birth of the infant; and (2) Before the mother and infant are separated. B. An individual employed by the institution who attends the birth shall securely attach matching identification bands to the wrists of the mother and infant. An additional matching band may be attached the infant's father or another individual designated by the infant's mother. C. The matching identification bands shall include: (1) The mother's name; (2) The same identification number for: (a) The infant; (b) The mother; and (c) If applicable, the father or any other designated person; (3) The infant's gender; (4) The date and time of birth; and (5) Any other information specified by the institution's policy. D. In the case of multiple births: (1) The identification band for each infant shall also include the infant's birth order indicated either alphabetically such as by A, B, C or numerically such as by 1, 2, 3; and (2) A band corresponding to each infant shall be attached to the mother. E. Any unused band shall be: (1) Attached to the mother; (2) Stapled to the mother's chart; or (3) Disposed of in a secure disposal box. F. An individual employed by the institution shall check the birth record and identification bands for accuracy before the mother or infant leaves the delivery room. G. Each institution shall implement policies requiring personnel to check to ensure that the identification bands of a mother and her infant match: (1) Each time the infant is taken to the mother while at the institution; and (2) At the time of the discharge of the mother and infant from the institution. #### Regulation .04 Identification of Newborn Infants — Additional Procedures Permitted. *COMAR 10.11.01.04* A. An institution may perform additional identification procedures on an infant before the infant leaves the delivery room. These methods do not link mother and infant, but may be useful in establishing the identity of an infant, and include: (1) Cord blood sampling; (2) Footprinting; (3) Taking a color photograph of the infant; (4) Physically assessing the infant and documenting of any distinguishing features; or (5) Another procedure proposed by the institution to the Secretary for approval that provides at least equivalent identification. B. An institution proposing to the Secretary another procedure to identify newborn infants shall include in the proposal at least the following information: (1) Method of collection; (2) Methods of storage; (3) Specimen labeling; (4) Specimen security and chain of custody; (5) Testing method, or methods to be used; (6) Circumstances for testing; (7) Quality assurance of tests; (8) Confidentiality issues; (9) Protection against unauthorized access; and (10) Record and documentation system. C. Identification of Policies and Procedures. An institution shall: (1) Develop policies and methods for conducting each additional infant identification procedure under this regulation, and each procedure shall be documented with at least the following information: (a) Mother's name; (b) Mother's patient identification number; (c) Date of birth; (d) Gender of the newborn infant; (e) Birth order if a multiple birth; and (2) Designate and train personnel responsible for performing newborn infant identification procedures. D. Verification. (1) An institution shall verify that the identification procedure was performed by completing a form supplied by the institution or related facility. Information on the form shall include, but need not be limited to the: (a) Type of identification procedures performed; (b) Date and time the identification procedure was performed; and (c) Name of personnel performing the identification procedure. (2) An institution shall enter this form, which lists at least the information required in §D(1)(a), (b), and (c), of this regulation, into the infant's institutional medical record and maintain it as part of the infant's overall institutional record. E. Retention. An institution shall retain any identifying material (blood sample or footprint) for at least 10 days or until the newborn is discharged, whichever comes later. ### Chapter 02 — Early Hearing Detection and Intervention Program **Authority:** Health-General Article, §§13-601—13-605, Annotated Code of Maryland **Administrative History:** Effective date: January 20, 1992 (19:1 Md. R. 32) **Administrative History:** Regulations .01—.09 repealed and new Regulations .01—.09 adopted effective June 22, 2015 (42:12 Md. R. 762) **Administrative History:** Regulation .03B amended effective March 30, 2026 (53:6 Md. R. 291) #### Regulation .01 Purpose. *COMAR 10.11.02.01* The Early Hearing Detection and Intervention Program shall provide for the universal hearing screening of newborns and early identification and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills. The Program shall identify newborns and infants who have a permanent hearing status that affects speech-language skills as early as possible. #### Regulation .02 Scope. *COMAR 10.11.02.02* This chapter requires the screening of all newborns and infants born in Maryland and follow-up for those who have, or are at risk for developing, a permanent hearing status that affects speech-language skills. #### Regulation .03 Definitions. *COMAR 10.11.02.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Alternative birthing site” means any site of birth other than a hospital. (2) “Appropriate services” mean any necessary audiological, medical, developmental, speech-language, sign language, psychosocial, educational, or intervention services required in the follow-up of newborns and infants who have or are at risk for developing a permanent hearing status that affects speech-language skills. (3) “At risk for developing a permanent hearing status that affects speech-language skills” means an infant identified as having any risk factor listed in Regulation .04 of this chapter. (4) “Audiological assessment” means testing to determine status of the auditory mechanism. (5) “Audiologist” means an individual licensed to practice audiology by the Maryland Board of Examiners for Audiologists, Hearing Aid Dispensers, and Speech-Language Pathologists. (6) “Birthing hospital” means a medical facility licensed by the Department which provides obstetrical services. (7) “Department” means the Maryland Department of Health. (8) “Department database” means the computer data management system used to gather and maintain program data. (9) “Early Hearing Detection and Intervention Advisory Council (Advisory Council)” means the 12-member advisory council appointed by the Secretary to provide advice and consultation to the Department concerning the Early Hearing Detection and Intervention Program. (10) “Early intervention system” means the total effort in the State, for children from birth to 5 years of age, to meet the needs of eligible children and the children’s families, including the efforts of the Maryland Early Hearing Detection and Intervention Program. (11) “Hearing screening” means behavioral, electrophysiological, or other procedures used to identify newborns and infants in need of diagnostic audiological assessment. (12) “Hearing status” means the state of an individual’s ability to perceive sound, based on audiological assessment. (13) “Infant” means a Maryland resident who is younger than 1 year old. (14) “Infant with a permanent change in hearing status that affects speech-language skills” means an infant who has a status that is an atypical function of the auditory system or any nontransient hearing status of any type or degree which is sufficient to interfere with the acquisition and development of speech-language skills with or without the use of sound amplification. (15) “Local education agency” means a public board of education and public school system legally constituted to administer and direct education and programs of education in the public elementary or secondary schools, including early childhood from birth through the end of high school or their equivalent, in Baltimore City and the 23 counties in Maryland. (16) “Local health department” means the official public health agency of the local political subdivision affiliated with the Department. (17) “Maryland Infants and Toddlers Program” means the program within the Maryland State Department of Education’s Division of Special Education/Early Intervention Services that provides early intervention services for children under Part C of the Individuals with Disabilities Education Act. (18) “Newborn” means a child up to 29 days old who is born in the State. (19) “Parent” means a biological or adoptive parent, a legal guardian, another individual responsible for a child’s welfare, or a person appointed as the surrogate parent as defined in COMAR 13A.05.01. (20) “Primary care provider” means a licensed practitioner who is the primary coordinator of care for the individual, whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services. (21) “Program” means the Early Hearing Detection and Intervention Program established by the Secretary that provides for the universal screening of newborns and early identification and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills. (22) “Referral” means directing the newborn or infant at risk for developing a permanent hearing status that affects speech-language skills and the newborn or infant’s parent or guardian to a professional for diagnostic audiological assessment or other appropriate services, or both. (23) “Risk factors” means indicators that are associated with permanent congenital, delayed-onset, or progression to a hearing status that affects speech-language skills in childhood. (24) “Secretary” means the Secretary of Health or the Secretary’s designee. (25) “Telephone resource line” means toll-free telephone access to the Program inside Maryland through live voice or recorded message that is compatible with telecommunication relay services. #### Regulation .04 High Risk Factors. *COMAR 10.11.02.04* Any of the following high risk factors are considered relevant in determining the possibility of a newborn or infant developing a permanent hearing status that affects speech-language skills under this chapter: A. Caregiver concern regarding hearing, speech, language, or developmental delay; B. Family history of a permanent hearing status that affects speech-language skills occurring during childhood; C. Medical risk factors: (1) Neonatal intensive care for more than 5 days; (2) Extracorporeal membrane oxygenation; (3) Assisted ventilation; (4) Hyperbilirubinemia that requires exchange transfusion of the blood; (5) Exposure to ototoxic medications, such as gentimycin and tobramycin; and (6) Exposure to loop diuretic medications, such as furosemide and lasix; D. In utero infections, such as cytomegalovirus, herpes, rubella, syphilis, and toxoplasmosis; E. Craniofacial anomalies; F. Physical findings associated with a permanent hearing status that affects speech-language skills; G. Diagnosis of a syndrome associated with a congenital or progressive change in hearing status that affects speech-language skills; H. Neurodegenerative disorders, including: (1) Hunter syndrome; and (2) Sensory motor neuropathies, such as Friedrich’s Ataxia and Charcot-Marie-Tooth disease; I. Culture-positive postnatal infections associated with a permanent change in hearing status that affects speech-language skills, including bacterial and viral meningitis; J. Head trauma, including basal skull and temporal bone fracture, that require hospitalization; and K. Chemotherapy. #### Regulation .05 Model System. *COMAR 10.11.02.05* The Department shall establish and maintain a model system to provide for the implementation of an early identification program and follow-up of newborns and infants who have or are at risk for developing a permanent hearing status that affects speech-language skills and includes the following components: A. Educational materials; B. Telephone resource line; C. Department database to gather and maintain program data; D. A service referral directory; E. In-service training of hospitals, local health departments, and local education agencies; F. Referral to appropriate agency or professional for services; G. Program monitoring and review; H. Confidentiality of records and information in accordance with Health-General Article, §§4-101 and 4-301 — 4-309, Annotated Code of Maryland; and I. Continuum of follow-up which includes: (1) Contacting the primary care provider in writing or by telephone to verify the status of the infant; (2) Contacting parents or guardians in writing or by telephone to facilitate referral for diagnostic audiological assessment and referral for appropriate services; and (3) Interfacing with the single point of entry for the early intervention system. #### Regulation .06 Early Hearing Detection and Intervention Advisory Council. *COMAR 10.11.02.06* The Advisory Council shall: A. Advise the Department on: (1) The implementation of an early identification program and follow-up of newborns and infants who have, or are at risk for developing, a permanent hearing status that affects speech-language skills; (2) Setting of standards for the Program including procedures for hearing screening; (3) Monitoring and reviewing of the Program; and (4) Provision of quality assurance for the Program; B. Provide consultation to the Department in the development of the Program; C. Make recommendations for operation of the Program; D. Provide consultation to the Department in the maintenance of an educational program for families, professionals, and the public integrated with the Maryland Infants and Toddlers Program and local early intervention systems, including existing State and local education agency programs; E. Review any materials the Department may distribute to the public concerning newborns and infants who have a permanent hearing status that affects speech-language skills; F. Meet annually with the Secretary or the Secretary’s designee; and G. Provide consultation to the Department in the adoption of rules and regulations necessary to implement the Program. #### Regulation .07 Procedures for Birthing Hospitals and Alternative Birthing Sites. *COMAR 10.11.02.07* For each infant delivered at the facility or site, birthing hospital staff and, in the cases of alternative birthing sites, the licensed professional attending the birth shall: A. Within 48 hours of delivery, enter demographic and birth event data into the Department database; B. Within 48 hours of discharge from care in the Department database: (1) Document: (a) The hearing screening test results; and (b) Any known risk factors; and (2) Identify and document: (a) The infant’s primary care provider; and (b) Any referrals made; and C. Provide to the family: (1) Written documentation of the birth hearing screening results; (2) Any identified risk factors; and (3) Instructions for any recommended follow-up. #### Regulation .08 Procedures for Audiologists and Licensed Professionals Conducting Audiological Screening or Evaluations. *COMAR 10.11.02.08* A. An audiologist or a licensed professional who performs a hearing screening or audiological diagnostic evaluation on a child younger than 5 years old due to the presence of a risk factor as listed in Regulation .04 of this chapter or in follow-up to the birth hearing screening of a newborn or infant who did not receive or did not pass the birth hearing screening shall: (1) Within 2 business days: (a) Report the results of the screening or audiological diagnostic evaluation to the Program in the Department database; (b) Document recommendations and referrals provided in the Department database; and (c) Confirm or update the demographic information of the child or infant in the Department database; and (2) Within 7 business days, notify the appropriate early intervention program at the Maryland State Department of Education of any child younger than 5 years old confirmed to have or strongly suspected of having a permanent hearing status of any type or degree as described in §B of this regulation which is sufficient to interfere with the acquisition and development of speech-language skills with or without the use of sound amplification. B. A child younger than 5 years old is strongly suspected of having a permanent hearing status if evidence or clinical judgment exists which indicates that there is a high probability of a permanent hearing status of any type or degree which is sufficient to interfere with the acquisition and development of speech-language skills. #### Regulation .09 Department Procedures. *COMAR 10.11.02.09* A. The Program shall: (1) Implement the model system; (2) Perform duties and responsibilities in accordance with the advice and consultation of the Advisory Council; (3) Exercise independent judgment in the day-to-day operations of the Program; (4) Develop Program processes in consultation with the Advisory Council; (5) Conduct in-service training on Program procedures; (6) Maintain a Department database to monitor infants at risk for developing a hearing status that affects speech-language skills; (7) Track infants identified as at risk for developing a permanent hearing status that affects speech-language skills for a period of 5 years; (8) Maintain a service directory within the Department database; (9) Assure operation of the telephone resource line; (10) Facilitate referral for diagnostic audiological assessment and early intervention for infants who are at risk for developing a permanent hearing status that affects speech-language skills; (11) Maintain records of the audiological assessment reports for infants at risk for developing a permanent hearing status that affects speech-language skills; and (12) Interface with the single point of entry of the early intervention system. B. The Secretary shall establish guidelines for the operation of the Advisory Council. ### Chapter 03 — Children's Medical Services Program **Authority:** Health-General Article, §15-125, Annotated Code of Maryland **Administrative History:** Effective date: September 21, 1986 (13:19 Md. R. 2121) **Administrative History:** Regulations .03, .05, and .12 amended as an emergency provision effective January 1, 1987 (14:2 Md. R. 125); adopted permanently effective March 31, 1987 (14:6 Md. R. 715) **Administrative History:** Regulation .12 amended effective August 24, 1987 (14:17 Md. R. 1871) **Administrative History:** Regulations .01—.12 repealed effective November 28, 1988 (15:24 Md. R. 2769) **Administrative History:** Regulations .01—.18 adopted effective November 28, 1988 (15:24 Md. R. 2769) **Administrative History:** Chapter revised and recodified from COMAR 10.22.08 to COMAR 10.11.03 effective March 1, 1993 (20:4 Md. R. 371) **Administrative History:** Regulation .01-1 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .02A, B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulations .03 and .08 amended as an emergency provision effective January 27, 1999 (26:4 Md. R. 269); amended permanently effective May 31, 1999 (26:11 Md. R. 855) **Administrative History:** Regulation .03B amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .03B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .08C amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .08E amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .10 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .10D-1 adopted effective March 28, 1994 (21:6 Md. R. 467) **Administrative History:** Regulation .10E—I repealed as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .20C amended effective April 24, 1995 (22:8 Md. R. 596) **Administrative History:** Regulation .20F repealed as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .21C amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .23 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .25D amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .26 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .27 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .28A amended effective March 28, 1994 (21:6 Md. R. 467) **Administrative History:** Regulation .30 repealed, new Regulations .30 and .31 adopted, and Regulation .31 recodified to Regulation .32 as an emergency provision effective January 27, 1999 (26:4 Md. R. 269); amended permanently effective May 31, 1999 (26:11 Md. R. 855) **Administrative History:** Regulation .30 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .30 repealed and new Regulation .30 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .30A amended effective March 28, 1994 (21:6 Md. R. 467); April 24, 1995 (22:8 Md. R. 596) **Administrative History:** Regulation .31 adopted effective March 28, 1994 (21:6 Md. R. 467) **Administrative History:** Regulation .31 amended as an emergency provision effective January 19, 2007 (34:4 Md. R. 396); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .31 repealed and new Regulation .31 adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Chapter revised effective April 13, 2015 (42:7 Md. R. 568) **Administrative History:** Regulation .14B amended effective February 27, 2017 (44:4 Md. R. 252) #### Regulation .01 Incorporation by Reference. *COMAR 10.11.03.01* In this chapter, the federal poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services, are incorporated by reference. #### Regulation .02 Definitions. *COMAR 10.11.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Agency” means a legally incorporated body or governmental unit which provides services to disabled children or their families, or both. (2) “Allowable cost” means the maximum amount which the Program will reimburse for the drug or product portion of the prescription. (3) “Appeal” means the process by which a child with special health care needs, as defined in §B(9) of this regulation, or the family on the child’s behalf, obtains a review of a decision, action, or lack of action on the part of the CMS Program or one of its designees. (4) “Applicant” means a child with special health care needs, as defined in §B(9) of this regulation, or the parent or guardian of a child, for whom a written application has been submitted to the CMS Program for services, but for whom eligibility has not yet been determined. (5) “Authorized services” means that care which is approved by the CMS Program for an eligible child. (6) “Care coordination services” means services to promote the effective and efficient utilization of resources to assure access to necessary comprehensive services. (7) “Care management plan (CMP)” means a written document that lists recommendations for care as specified by a licensed and boarded provider. (8) “Children’s Medical Services Program (CMS Program)” means that program which is administered by the Department pursuant to Health-General Article, §15-125, Annotated Code of Maryland, to: (a) Provide for specialized medical, surgical, pharmacologic, and related rehabilitative evaluation and treatment services for children with special health care needs younger than 22 years old who: (i) Meet the residential, identification, financial, and medical eligibility requirements; and (ii) Are uninsured or do not have coverage in their existing health insurance plans that cover certain types of medical care; (b) Provide and promote family-centered, community-based, coordinated care for children with special health care needs, and promote development of community-based, culturally competent systems of services for those children and their families throughout the State; and (c) Distribute funds to cover specialty diagnostic and treatment services for eligible children with special health care needs in Maryland. (9) “Children with special health care needs” means individuals, birth to 22 years old, who have or who are at increased risk for a chronic physical, development, behavioral, or emotional condition and who also require health and related services of a type or amount beyond that required by children generally. (10) “Department” means the Maryland Department of Health, the single State agency designated to administer the CMS Program. (11) “Disabling condition” means a health-related condition or impairment that may hinder achievement of normal growth and development. (12) “Disposable medical supplies” means consumable or disposable items with minimal or no potential for reuse which are used to serve a medical purpose. (13) “Durable medical equipment” means equipment which satisfies all of the following requirements: (a) It can withstand repeated use; (b) It is used to serve a medical purpose; and (c) It is appropriate for use in the home. (14) “Federal poverty level” means the poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services. (15) “Financial eligibility guidelines” means the schedule based upon the federal poverty level which is used to determine financial eligibility for the CMS Program. (16) “General hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed as a general hospital by the Maryland Department of Health, Division of Licensing and Certification, in accordance with COMAR 10.07.01. (17) “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Maryland Department of Health which is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (18) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01, or other applicable standards established by the state in which the services are provided. (19) “Income” means any property or service received by a person in cash or in kind which can be applied directly to meet basic needs for food, shelter, and medical expenses. (20) “Long-term hospitalization” means an inpatient stay of more than 2 weeks. (21) “Medical assistance” has the meaning stated in COMAR 10.09.24.02. (22) “Medical care” means medical services and specialized care provided by physicians and allied health professionals in hospitals, convalescent facilities, clinics, private physicians’ offices, in home and other community-based settings. Medical care may include the services rendered by dentists, nurses, medical social workers, childlife specialists, nutritionists, dietitians, psychologists, physical therapists, occupational therapists, speech-language pathologists, audiologists, optometrists, ophthalmologists, technicians, and other pertinent personnel whose services may be needed by those children who are served by the CMS Program. (23) “Medically necessary dental care” means reasonable and appropriate diagnosis, treatment, and follow-up care as determined and prescribed by qualified, appropriate health care providers in treating a condition, disease, injury, birth defect, or development malformation to restore facial configuration or function necessary for speech, swallowing, or chewing. (24) “Physician specialist” means a: (a) Licensed medical doctor who is qualified to practice medicine in a specialty area and who is either board certified or board eligible and who has experience in the care of children; or (b) Resident physician under the supervision of a licensed board-certified physician. (25) “Preauthorization” means an approval required from the Department or its designee before the provision of services. (26) “Provider” means an individual or entity duly licensed or certified to render a health care service or product pursuant to these regulations through an appropriate agreement with the Department, and identified as a CMS Program provider by the issuance of an individual vendor number. (27) “Residency” means living in the State voluntarily with the intention of making the State the individual’s permanent home for an indefinite period and not for a temporary purpose. #### Regulation .03 Covered Services. *COMAR 10.11.03.03* A. The CMS Program shall authorize covered services when a CMP has been approved. B. The CMP shall: (1) Include: (a) All diagnoses or suspected diagnoses; (b) Service requested or provided; (c) Specific reason for the service request; (d) Evaluation or treatment findings; (e) Follow-up plans related to the service provided by the CMS Program; (f) Source of primary health care; and (2) Be reviewed and approved by the CMS Program. C. The CMS Program may request further information from the provider in order to: (1) Support the information required in §B(1) of this regulation; (2) Assure that all services are coordinated with other services the child is receiving through the CMS Program or other programs; and (3) Assure that the needs of the family are addressed in relation to meeting the medical and developmental needs of the child. D. CMS Program eligible services shall include: (1) Specialty clinics; (2) Private office care including, but not limited to, the following: (a) Allergy/Immunology; (b) Audiology and hearing; (c) Cardiology; (d) Craniofacial; (e) Cystic fibrosis; (f) Developmental pediatrics; (g) Endocrine; (h) Gastroenterology; (i) Genetics; (j) Hematology; (k) Infectious disease; (l) Nephrology; (m) Neurology; (n) Neurosurgery; (o) Oncology; (p) Ophthalmology, optometry, and vision; (q) Orthopedics; (r) Otolaryngology; (s) Physical medicine; (t) Plastic surgery; (u) Pulmonology; (v) Rheumatology; (w) Speech-language pathology; (x) Surgery; and (y) Urology. (3) Primary physician care arranged at the discretion of the CMS Program to assure access for needed specialty diagnostic evaluation, treatment, and care coordination services; (4) Inpatient hospital care services, which are provided by Medical Assistance affiliated hospitals; and (5) Professional evaluation and treatment services, which may include, but are not limited to, the following: (a) Audiology; (b) Family training and counseling regarding medical and rehabilitation needs; (c) Genetic counseling; (d) Nursing; (e) Nutrition; (f) Occupational therapy; (g) Physical therapy; or (h) Speech-language pathology. E. Specialized activities to facilitate a special treatment program may include, but are not limited to, the following: (1) Equipment to provide: (a) Life support; (b) Mobility; (c) Stimulation; and (d) Aid in activities of daily living; (2) Orthoses to correct or prevent orthopedic disabilities, including prescription shoes and their modifications; (3) Prostheses to replace a missing part or to enhance the applicant's functional performance; (4) Formula and medication to correct metabolic and physiologic errors; (5) Supplies of durable and disposable items to facilitate management of specific disorders; (6) Approved therapies involving specific treatment as authorized by appropriate CMS Program professional staff to cure functional deficiencies; (7) Life sustaining medications; (8) Dental services provided for children with disabling conditions; and (9) Hearing aids and augmentative devices to improve communication. #### Regulation .04 Rights and Responsibilities. *COMAR 10.11.03.04* A. Applicant. (1) The applicant shall furnish factual information regarding the applicant’s eligibility, and shall keep the CMS Program informed of any change in demographic, financial, medical, or insurance coverage status. (2) An eligible applicant shall use only Medical Assistance approved providers. (3) An applicant shall complete a Medical Assistance application when the applicant is considered potentially eligible. B. CMS Program. (1) An applicant who meets eligibility criteria as set forth in this chapter shall have access to approved services within the budgetary limitations of the CMS Program. (2) The CMS Program may purchase health insurance benefits for an eligible child when all of the following conditions are met: (a) The cost of this expense is less than the cost of directly purchasing the child’s medical care; (b) The policyholder is unable to pay for the health insurance policy due to: (i) An increase in insurance cost; (ii) A change in employment; (iii) Loss of income; (iv) An increase in health-related expenses; or (v) The policyholder’s eligibility to purchase health insurance benefits in accordance with the Consolidated Omnibus Budget Reconciliations Act of 1985, P.L. 99-272; (c) The health insurance policy is issued directly from: (i) An authorized insurer; (ii) A nonprofit health services plan; (iii) A health maintenance organization; (iv) A self-insured health benefit plan; or (v) The employer of the family member whose health insurance provides coverage for the eligible child; and (d) Payment is for premiums that can be costed out as related to the applicant only. (3) The CMS Program may pay copays, deductibles, and coinsurance costs when the CMS Program is purchasing the health insurance benefits. (4) The CMS Program shall comply with the requirements of: (a) Title VI of the Civil Rights Act of 1964 as amended; (b) The Age Discrimination Act of 1975 as amended; (c) Section 504 of the Rehabilitation Act of 1973 as amended; and (d) The Americans with Disabilities Act of 1989. (5) The CMS Program shall determine financial assistance based on the income and allowable deductions. (6) The CMS Program shall provide full financial assistance for authorized services when the income is equal to or less than that which is allowable in accordance with the financial eligibility levels described in Regulation .05A(4) of this chapter. (7) The CMS Program shall provide full CMS Program eligible service to the extent that medical assistance for this service is not covered under Title XIX. #### Regulation .05 General Eligibility Criteria. *COMAR 10.11.03.05* A. To be eligible for the CMS Program’s services, an applicant shall: (1) Submit a completed, signed, and dated CMS Program application; (2) Provide documentation of: (a) State residency, as this program is not meant to cover those whose sole purpose in coming to Maryland is to obtain medical care or coverage; and (b) Being younger than 22 years old; (3) Provide a form of identification for the applicant and the applicant’s parents or guardians if the applicant is less than 18 years old; (4) Have income that does not exceed: (a) 200 percent of the federal poverty level; or (b) 250 percent of the federal poverty level, if the applicant is eligible for a medical deduction under Regulation .07D of this chapter; and (5) Have an eligible medical condition as set forth in Regulation .06 of this chapter. B. The age eligibility referred to in §A(2)(b) of this regulation may be extended 3 years beyond the 22nd birthday if the CMP: (1) Confirms that current treatment of the condition should be continued in order to prevent a significant disruption in the provision of necessary services; and (2) Documents that the applicant is without third-party insurance or entitlement coverage. #### Regulation .06 Medical Eligibility. *COMAR 10.11.03.06* A. Children with special health care needs may be eligible for services covered by the CMS Program. B. Chronic medical conditions which may render an applicant medically eligible include, but are not limited to, the following: (1) Chronic asthma; (2) Chronic renal disease; (3) Cystic fibrosis; (4) Diabetes and other endocrine disorders; (5) Hemophilia; (6) Immune deficiencies; (7) Juvenile rheumatoid arthritis; (8) Leukemia and other childhood cancers; (9) Phenylketonuria and other inborn errors of metabolism; and (10) Sickle cell anemia and other chronic anemia. C. Other medical and surgical conditions which may render an applicant medically eligible include, but are not limited to, the following: (1) Biliary atresia; (2) Bronchopulmonary dysplasia; (3) Tracheal esophogeal fistula; and (4) Ulcerative colitis. D. Neurodevelopmental conditions which may render an applicant medically eligible include, but are not limited to, the following: (1) Brain tumors; (2) Cerebral palsy and other central nervous system disorders; (3) Certain high risk neonates; (4) Closed head injury with residual defects; (5) Down's syndrome and other genetic and chromosomal anomalies; (6) Hydrocephalus; (7) Medical aspects of learning disabilities and attention deficit disorders; (8) Medical aspects of intellectual disability and developmental delay; (9) Muscular atrophies and dystrophies; (10) Spina bifida, myelomeningocele, and the spinal cord dysfunctions; (11) Other neurologic damage; (12) Peripheral neuromuscular disease; and (13) Seizure disorder. E. Orthopedic conditions which may render an applicant medically eligible include, but are not limited to, the following: (1) Chronic conditions resulting from trauma; (2) Chronic infections of bones and joints; (3) Club foot and other foot deformities; (4) Congenital developmental hip conditions such as congenital hip dislocation; (5) Limb deficiencies and length discrepancies; (6) Skeletal dysplasias and other forms of dwarfism; and (7) Spinal column defects and deformities. F. Cardiac conditions which may render an applicant medically eligible include, but are not limited to, the following: (1) Arrhythmias; (2) Congenital heart defects; (3) Hypertension; and (4) Rheumatic heart disease. G. Craniofacial and dental conditions which may render an applicant medically eligible include, but are not limited to, the following: (1) Cleft lip and palate, orofacial defects; (2) Handicapping malocclusions; and (3) Medically necessary dental care related to eligible medical conditions. H. Vision, hearing and speech-language conditions, which may render an applicant medically eligible include, but are not limited to, the following: (1) Amblyopia; (2) Cataract; (3) Cholesteatoma; (4) Chronic otitis media; (5) Conductive and sensory-neural hearing loss; (6) Otosclerosis; (7) Speech-language disorders; (8) Strabismus; and (9) Velopharyngeal incompetence. I. The following are excluded from CMS Program medically eligible services: (1) Well child care; (2) Mental health; (3) Emergency care; and (4) Urgent care. J. Care excluded from CMS Program medically eligible conditions unless the services are medically necessary due to the underlying chronic condition includes: (1) Dermatology; (2) Gynecology; and (3) Dental services. #### Regulation .07 Financial Eligibility. *COMAR 10.11.03.07* A. An applicant's financial eligibility is based upon the composition and income of the family unit. B. Family Unit. A family unit consists of one or more of the following members residing in the same household: (1) The applicant; (2) The natural or adoptive parents, stepparents, or legal guardian if the applicant is unmarried; (3) The unmarried natural or adoptive siblings of the applicant who are younger than 22 years old; (4) The lawful spouse of the applicant; or (5) Other individuals who are not included in this regulation and who are dependents for federal income tax purposes. C. Income. (1) For the purpose of determining financial eligibility, the CMS Program shall treat the income of members of the family unit listed in §B of this regulation as the sole source for determining an applicant’s eligibility. (2) The CMS Program shall determine the family’s income from the following sources: (a) Wages, including sick or severance pay; (b) Commissions and fees; (c) Salaries and tips; (d) Profit from self-employment, including income from the operation of a farm; (e) The earned income tax credit (EITC); (f) Social Security benefits; (g) Veterans' Administration benefits; (h) Workers' Compensation benefits; (i) Black Lung or Agent Orange benefits; (j) Railroad Retirement; (k) Government, private, or company pensions and annuities; (l) Unemployment insurance benefits; (m) Payments from oil or mineral rights (leases); (n) Government payments on land; (o) Insurance benefits paid directly to an applicant; (p) Trust funds; (q) Individual retirement accounts (IRAs); (r) Keough plans; (s) Military allotments; (t) Alimony or court-ordered and voluntary child support payments received from an absent spouse, or an absent natural or adoptive parent; (u) Loan repayments made to the applicant or family member including, but not limited to, mortgage payments; (v) Lump-sum benefits or other amounts of income received on a one-time-only basis; (w) Profit from rental income; (x) Cash assistance received from non-governmental social service agencies greater than the amount allowed by Medical Assistance; (y) Sick pay which does not count as earnings for deduction purposes under Title II of the Social Security Act; and (z) Any subsidy covering basic needs for food or shelter. (3) If an individual in the family unit has recently resumed employment, the Program shall determine income for a 12-month period by averaging actual income for 6 months preceding resumption of employment and projected income for 6 months following resumption of employment. (4) If additional CMS Program services are requested 6 months after resuming employment, the CMS Program may re-determine financial eligibility based on current income. D. Medical Deductions. The applicant may deduct the following from the applicant’s income: (1) Loan payments related to medical or medically related emergency debt; (2) Payment to a hospital or other health care provider for a member of the family unit not covered by other third-party insurance entitlements, or the Program; and (3) Payments for health insurance for a member of the family unit. E. Effective Dates for Financial Eligibility. (1) The CMS Program shall establish financial eligibility for a 12-month period from the date a completed application is received by the CMS Program. (2) Exceptions to the 12-month financial eligibility period are: (a) If financial eligibility was determined by averaging the previous 6 months, financial eligibility shall be reconsidered after 6 months; (b) When an eligible applicant enrolled in the CMS Program informs the CMS Program of changes in family size, income, or expense, the CMS Program may reconsider eligibility as soon as possible if financial assistance is being given, or when the next request for services is made. (3) Those receiving CMS Program financial assistance shall notify the CMS Program within 10 business days of any changes in circumstance which could affect continuing financial eligibility. #### Regulation .08 Application Process. *COMAR 10.11.03.08* A. The CMS Program shall make applications available to, but which are not limited to, the following agencies: (1) Local health department; (2) Admitting, social services, or business office of a participating hospital; (3) Cooperating agencies; and (4) An applicant, upon request. B. Completion of Application. (1) An applicant, the applicant's parent, guardian, or representative shall submit a complete, signed application approved by the Program. (2) A parent of any age, or an authorized representative of the applicant who is 18 years old or older, shall complete and sign the application for an unmarried applicant younger than 18 years old. (3) A representative of a public or private agency, which may include a foster parent, shall complete and sign the application for a child in custody of the agency. (4) An applicant shall provide financial information for each employed member of the family unit as specified in Regulation .07A of this chapter. (5) An applicant shall provide documents verifying residency, identification, income, and medical conditions or suspected medical conditions. (6) The CMS Program shall make reasonable accommodations to assure that appropriate assistance is provided to those who are disabled or who are unable to speak or write English. #### Regulation .09 Disposition of Application. *COMAR 10.11.03.09* A. General. (1) The CMS Program professional staff shall: (a) Review individual applications; (b) Determine CMS Program eligibility and services to be approved for payment by the CMS Program within 30 calendar days of receipt of the complete application; (c) Verify the information provided by an applicant which may include an interview: (i) With the applicant if the applicant is 18 years old or older, or with the applicant’s parent or guardian; and (ii) Which is held at a mutually convenient place and time for all parties. (2) If additional information is needed to determine eligibility or service needed, the Program shall: (a) Return the application within 15 business days of receipt; and (b) Advise an applicant in writing of needed documentation. (3) Within 30 calendar days of receipt of the completed application by the CMS Program the CMS Program shall send a written decision regarding Program eligibility to the applicant. (4) For renewal applications, the CMS Program shall notify an applicant in writing at least 30 calendar days before the date on which the applicant shall reapply. B. Eligible Applicant. (1) An eligible applicant shall receive a letter from the CMS Program which includes, at a minimum, the following information: (a) The effective dates of CMS Program eligibility; (b) The name of the provider; and (c) The service to be covered by the CMS Program. C. Ineligible Applicant. (1) An applicant is ineligible when the applicant does not: (a) Provide requested information sufficient to determine eligibility; (b) Complete, sign, and date the application; or (c) Complete an application for Medical Assistance when the applicant is potentially eligible for services covered by Medical Assistance. (2) An applicant determined ineligible shall receive a letter from the CMS Program informing the applicant of the reasons for the determination. (3) An applicant determined to be ineligible shall be advised of the right to appeal the determination in accordance with the procedures set forth in §D of this regulation. D. Appeal Rights. (1) Providers filing appeals of administrative decisions made in connection with these regulations shall do so in accordance with Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (2) An applicant or eligible individual, or other authorized representative has a right to a meeting or informal conference with CMS staff responsible for a decision reflected in any notice of determination issued in this chapter. #### Regulation .10 Record Retention and Confidentiality. *COMAR 10.11.03.10* A. Records. (1) A provider shall: (a) Retain and reproduce, upon request for a minimum of 6 years, records and reports required by the Department for the administration of services; and (b) Be responsible for maintaining patient records for services that it provides in accordance with the approved Department retention schedule. (2) Records referred to in §A(1) of this regulation include: (a) Documentation of personal interviews; (b) Diagnosis and treatment recommendations; (c) Records of professional visits and consultations; (d) Consultant notes which shall be appropriately initialed or signed; (e) Medical and laboratory data, including X-rays; and (f) Other data as may be required by applicable federal and State regulations. B. Confidentiality. A provider shall assure that the release of information from an eligible applicant's record is handled in accordance with Health-General Article, §§4-301—4-309, Annotated Code of Maryland, COMAR 10.03.02, and other State and federal laws and regulations governing the confidentiality of records. #### Regulation .11 General Conditions of Provider Participation. *COMAR 10.11.03.11* A. A provider of services which are covered by the CMS Program shall comply with the following general requirements: (1) For fee for service reimbursement, be approved by Medical Assistance in writing as a Medical Assistance provider; (2) For copay and deductible reimbursement, be a participating provider with the insurance plan purchased by the CMS Program for the family; (3) Request preauthorization on the forms designated by the CMS Program; (4) Adhere to administrative procedures that are established by the CMS Program for the specific treatment services; and (5) Maintain adequate records, including prescriptions, for a minimum of 6 years, and make them available upon request to the Department or the Department's designee. B. The approval referenced in §A(1) of this regulation shall specify, at a minimum, the following: (1) Approved services which may be provided; and (2) Duration of approval status. #### Regulation .12 Conditions of Hospital Participation. *COMAR 10.11.03.12* A hospital shall: A. Comply with all relevant State and federal requirements related to the provision of health services and the receipt of funds; B. Be licensed by the Department pursuant to the Hospital and Related Institutions subtitle, Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, as a hospital, and be licensed, as may be required, by other applicable State and local laws; C. Be accredited by the Joint Commission for Accreditation of Hospitals; and D. Provide the following services: (1) A physician specialist who is qualified in the area of need for which a recipient is hospitalized, and who shall supervise and be involved in: (a) The ongoing care of a child; and (b) Directing the development of the CMP and other appropriate care plans; (2) Pediatric physician supervision on a full-time or part-time basis to assist with: (a) Diagnostic evaluations; (b) Care planning and treatment; and (c) Coordination with others involved in the development of the CMP; (3) Nursing services provided by a qualified nurse who has academic preparation and work experience in the care of children, including the specialty area of the condition to be treated; (4) Surgical services, which shall have, as a minimum: (a) Anesthesiologists trained and experienced in the management of pediatric patients; and (b) An appropriate recovery area which is staffed by personnel qualified in pediatrics and equipped with appropriate types and sizes of supplies and equipment; (5) Available consultation in other specialty areas for the cases being treated; (6) Other specialized support services, which shall include, but not be limited to, the following as appropriate: (a) Audiology; (b) Nutrition; (c) Occupational therapy; (d) Physical therapy; (e) Psychiatry; (f) Psychology; (g) Social work services; and (h) Speech-language pathology; (7) An ongoing inpatient educational program for school-age children, which is approved by the State Department of Education, when long-term hospitalization is required; (8) Discharge planning procedures designed to maximize a child's recovery and rehabilitation, which shall include the following: (a) Predischarge planning activities to include all appropriate staff and representatives of other agencies involved or indicated; (b) Parental counseling regarding a child's medical and social needs after the child's release; and (c) Medical care planning resulting from input of the professionals concerned with a child's treatment; (9) A discharge summary, which shall include as a minimum, the following: (a) Medications, primary and secondary diagnoses, hospital course, procedures performed, and complications; (b) Special equipment and other home care needs; and (c) Follow-up plans including special transportation needs, if applicable; (10) A separate area for a child, with provisions made for a parent or guardian to stay 24 hours, and nonrestrictive visiting hours for a parent or guardian; (11) Suitable recreational facilities for children; (12) Facilities to isolate children with communicable diseases or other conditions requiring isolation or separation; (13) Access to appropriate clinical laboratory facilities providing specialized diagnostic and treatment equipment, including radiological and nuclear medicine equipment; and (14) Outpatient facilities to provide follow-up care. #### Regulation .13 General Billing Procedures. *COMAR 10.11.03.13* A. A provider shall accept payment at the Medical Assistance rate as payment in full. B. A provider shall submit: (1) Requests for payment on the form designated by the CMS Program; and (2) Completed reports and attachments as requested by the CMS Program. C. A provider may not bill the CMS Program for: (1) Completion of forms and reports; (2) Broken or missed appointments; (3) Professional services rendered by mail or telephone; and (4) Services which are provided at no charge to the general public. D. The CMS Program shall: (1) Make no direct payment to the family; (2) Pay any claim for services provided on different dates and submitted on a single form, and only if it is received by the CMS Program within 12 months of the earliest date of service; and (3) Pay a claim which is rejected for payment due to improper completion or incomplete information, only if it is properly completed, resubmitted, and received by the CMS Program within the original 12-month period or within 60 calendar days of rejection, whichever is later. E. The CMS Program reserves the right to return to the provider, before payment, all: (1) Invoices not properly signed, completed, and accompanied by properly completed forms as required by the Department, to include any necessary preauthorization forms; and (2) Claims not properly completed. F. If payment is denied by the CMS Program due to late billing, the provider may not seek payment from the child’s family. #### Regulation .14 Billing Procedures for Physician Office Services. *COMAR 10.11.03.14* A. A physician shall: (1) Comply with all procedures listed in Regulation .13 of this chapter; (2) Charge the CMS Program the usual and customary charge to the general public for similar services; and (3) Bill the CMS Program as specified by the CMS Program. B. The CMS Program shall: (1) Use the fee schedule contained in the Maryland Medical Assistance Program’s Professional Services Provider Manual and Fee Schedule, which is incorporated by reference in COMAR 10.09.02.07D; (2) Pay for covered services that are the lower of the: (a) Physician’s customary charge; or (b) Department's fee schedule; (3) Reimburse the provider for: (a) Dispensed drugs at rates established by COMAR 10.09.03; and (b) Injectable drugs at rates promulgated by the Professional Services Provider Manual and Fee Schedule referenced in §B(1) of this regulation. C. The CMS Program reserves the right to negotiate and establish a different fee for the physician or the group of physicians under contract to a hospital to provide services when a portion of the cost of the contract is paid as the hospital’s cost. #### Regulation .15 Billing Procedures for Medically Necessary Dental Services. *COMAR 10.11.03.15* A. A dentist shall comply with all procedures listed in Regulation .13 of this chapter. B. The CMS Program shall: (1) Cover approved diagnostic, restorative, and preventive treatment as described in the CMP; and (2) Preauthorize estimates of costs. #### Regulation .16 Billing Procedures for Orthodontic Services. *COMAR 10.11.03.16* A. An orthodontist shall comply with all procedures listed in Regulation .13 of this chapter. B. The CMS Program shall: (1) Reimburse for correction of the full permanent dentition; and (2) Give special consideration to services for children with malocclusions in the mixed dentition associated with cleft palates or other craniofacial deformities C. The CMS Program may not reimburse for preliminary visits to the orthodontist. D. The provider may not charge the patient, parent, or guardian for orthodontic treatment, including retention visits. #### Regulation .17 Billing Procedures for Durable Goods and Equipment. *COMAR 10.11.03.17* A. The durable goods and equipment providers shall comply with all procedures listed in Regulation .13 of this chapter. B. A provider shall charge the CMS Program the usual and customary charge to the general public for similar durable goods and equipment. C. The CMS Program shall: (1) Pay for covered services which are the least expensive, except for those described in §B of this regulation; (2) Determine, based upon expected duration of medical needs, whether durable medical equipment will be purchased or rented; and (3) Pay for repairs to purchased durable medical equipment and disposable medical supplies according to the Medical Assistance reimbursement rate for charges. D. The ownership of equipment shall remain with the CMS Program and shall be recovered at the option of the CMS Program. #### Regulation .18 Billing Procedures for Pharmacy Services. *COMAR 10.11.03.18* A. A pharmacy provider shall comply with all procedures listed in Regulation .13 of this chapter. B. A pharmacy provider shall: (1) Upon request, produce records to verify any charge to the CMS Program; and (2) Charge the CMS Program the usual and customary charge to the general public for similar prescriptions. C. Determination of allowable cost for multiple source drugs designated by the Centers for Medicare and Medicaid Services of the Department of Health and Human Services or for each drug listed in the formulary allowable cost shall be the lowest of the maximum allowable cost. D. Payment for covered services to a pharmacy shall be made as follows: (1) Payment for formulary drug preparation shall be the: (a) Least expensive available; or (b) Allowable cost according to the State Title XIX Agency; (2) Payment for over-the-counter drugs is not covered except in extenuating circumstances at the discretion of the CMS Program. #### Regulation .19 Billing Procedures for Hospitals. *COMAR 10.11.03.19* A. All hospitals shall comply with the following procedures: (1) Hospitals located in Maryland that participate in the CMS Program shall charge and be reimbursed at the Medical Assistance rates approved by the Health Services Cost Review Commission; (2) The CMS Program shall pay room and board charges for the day of admission, and may not pay room and board charges for the day of discharge from the hospital; (3) The CMS Program may not reimburse for the services of a hospital’s salaried or contractual physicians as a separate line item; (4) The contractual physicians' salaries shall be included in the room and board rate or the appropriate ancillary service; (5) When a patient is discharged from one general hospital and is admitted to another general hospital and 24 hours have not elapsed between the discharge and admission, the CMS Program shall pay only for those medically necessary days, with the payment for the patient’s hospitalization being apportioned between the two hospitals; (6) The CMS Program shall be contacted regarding exceptions or extenuating circumstances relating to admissions and discharges if the patient returns the same day before the hospital patient count; (7) All nonemergency inpatient hospital admissions require preadmission approval by the CMS Program; (8) Authorization is required by the CMS Program or its designee for more than one preoperative inpatient day; and (9) The CMS Program may not reimburse for hospital admissions where a child has been discharged due to cancellation of planned surgery or treatment. The hospital may not bill the family for these charges. B. In addition, all out-of-state providers shall: (1) Participate in Title XVIII of the Social Security Act; (2) Have in effect a utilization review plan applicable to all patients who receive Medical Assistance under Title XIX of the Social Security Act and which meets the requirements of the Social Security Act, §186(k), unless a waiver has been granted by the Secretary of Health and Human Services; and (3) Meet additional conditions for participation and comply with the requirements specified in Regulation .11 of this chapter. C. All hospital services shall be reimbursed at the Medical Assistance rate. #### Regulation .20 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.11.03.20* A. If the Department determines that a provider, vendor, agent or employee of the provider, vendor, or a person with an ownership interest in the provider or vendor has failed to comply with these regulations, or applicable federal or State laws or regulations, the Department may initiate one or more of the following actions against the responsible party: (1) Suspension from the CMS Program; (2) Withholding of payment from the CMS Program; (3) Removal from the CMS Program; and (4) Disqualification from future participation in the CMS Program, either as a provider or vendor providing services for which CMS Program payment may be claimed. B. If the Secretary of the United States Department of Health and Human Services suspends or removes a provider from participation in Medicare or Medical Assistance, the Department shall take similar action. #### Regulation .21 Funding Availability. *COMAR 10.11.03.21* Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland. ### Chapter 04 — Lead Poisoning Screening Program **Authority:** Education Article, §7-403; Environment Article, §6-303; and Health-General Article, §18-106; Annotated Code of Maryland **Administrative History:** Effective date: May 12, 2003 (30:9 Md. R. 614) **Administrative History:** Regulation .02B amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845) **Administrative History:** Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 407); December 25, 2023 (50:25 Md. R. 1087) **Administrative History:** Regulation .03 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845) **Administrative History:** Regulation .04 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845) **Administrative History:** Regulation .04 amended effective March 16, 2015 (42:5 Md. R. 486); March 28, 2016 (43:6 Md. R. 407); December 25, 2023 (50:25 Md. R. 1087) **Administrative History:** Regulation .05 amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845) **Administrative History:** Regulation .05 amended effective March 28, 2016 (43:6 Md. R. 407) **Administrative History:** Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 407) **Administrative History:** Regulation .06A amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845) #### Regulation .01 Purpose. *COMAR 10.11.04.01* The purpose of this chapter is to set forth requirements for conducting lead poisoning risk assessments, blood tests for lead poisoning of minor children, and the reporting of blood lead analysis in accordance with applicable State law. #### Regulation .02 Definitions. *COMAR 10.11.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administer a blood test for lead poisoning” means to: (a) Draw a blood specimen, by either venous or capillary methodology, and: (i) Send the specimen to a medical laboratory for blood lead analysis; or (ii) Conduct a blood lead analysis at a health care provider's office subject to licensing, certification, and approval by the Laboratories Administration of the Department; or (b) Order a blood specimen to be drawn by a third-party health care provider, by either venous or capillary methodology, and sent to a medical laboratory for blood lead analysis. (2) “At-risk area” means any geographic area within the State that has been designated by the Department as at-risk for lead exposure in the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning. (3) “Blood lead analysis” means the analysis and determination by a medical laboratory of the blood lead level in a blood specimen. (3-1) “Blood lead reference value” means a blood lead level of 3.5 micrograms per deciliter. (4) “CDC” means the federal Centers for Disease Control and Prevention. (5) “Child” means an individual younger than 18 years old. (6) Repealed. (7) “Department” means the Maryland Department of Health. (8) Repealed. (9) “EPSDT” means the Early and Periodic Screening Diagnosis and Treatment program governed by COMAR 10.09.23. (10) “Health care provider” means a person who is licensed, certified, or otherwise authorized to provide health care services under the Health Occupations Article, Annotated Code of Maryland. (11) Repealed. (12) “Immunization registry” means an immunization registry established and maintained by the Department. (13) “Lead exposure risk questionnaire” means the set of questions used to determine an individual's risk for lead exposure and lead poisoning, as approved by the Department and based on the recommendations from the CDC. (14) Repealed. (15) “Medical laboratory” means a licensed medical laboratory as defined by Health-General Article, §17-201(b), Annotated Code of Maryland. (16) “Nonprimary care” means health care that: (a) Is given or recommended by a health care provider that is not the individual's primary care provider; and (b) Includes but is not limited to episodic health care for acute illness or injury or health care that is given in an emergency room or other urgent care setting. (17) Prekindergarten Program. (a) “Prekindergarten program” means a public educational or public early intervention program that enrolls or serves children below the level of kindergarten. (b) “Prekindergarten program” includes: (i) Programs that operate within a school and those that operate outside of a school; (ii) Preschool special education programs governed by COMAR 13A.05.01; (iii) Extended Elementary Education Programs governed by COMAR 13A.06.02.01; (iv) Local Infant and Toddler Programs as defined in COMAR 13A.13.01; (v) Head Start and Early Head Start Programs as authorized under the Head Start Act, 42 U.S.C. §9801 et seq.; (vi) Judith P. Hoyer Early Child Care and Education Centers established by Education Article, 5-217, Annotated Code of Maryland; and (vii) Any other educational or early intervention program as determined by the Department. (18) “Primary care” means health care that: (a) Is continuous, comprehensive and coordinated; (b) Emphasizes prevention of illness and injury; and (c) Includes but is not limited to the following services; (i) Age appropriate screenings; (ii) Diagnosis and treatment of acute and chronic disorders; (iii) Growth and developmental assessments; (iv) Health care supervision; (v) Immunizations; (vi) Patient and parent health and psychosocial counseling; (vii) Physical examinations; and (viii) Referrals to specialty health care providers. (19) “Primary care provider” means a health care provider that provides primary care. (20) “Targeting Plan” means the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning developed by the Department that includes but is not limited to: (a) Methodology for determining levels of risk for childhood lead poisoning; (b) Maps of the State designating at-risk areas; (c) Zip code and census tract lists indicating each zip code and census tract's designated level of risk; and (d) Recommendations regarding the prevention of childhood lead poisoning. (21) “12-month visit” means a well-child evaluation by a health care provider that occurs when a child is between 12 months old and 14 months old. (22) “24-month visit” means a well-child evaluation by a health care provider that occurs when the child is between 24 months old and 26 months old. (23) “Well-child evaluation” means a periodic primary care assessment of a child by a primary care provider in accordance with the: (a) American Academy of Pediatrics' guidelines; or (b) Periodicity schedule established under EPSDT requirements. #### Regulation .03 Administration of Lead Exposure Risk Questionnaire. *COMAR 10.11.04.03* A primary care provider for a child shall complete a lead exposure risk questionnaire: A. During the 12-month visit and again during the 24-month visit if the child does not reside in an at-risk area; B. If the child does not reside in an at-risk area and is 24 months old or older and younger than 6 years old, and the provider does not have documentation that a blood test for lead poisoning or a lead exposure risk questionnaire has been previously administered to, or completed on behalf of, the child; C. At each well-child check for a child who is 6 months old or older and younger than 6 years old, and resides in an at-risk area; and D. In accordance with the EPSDT requirements for a child insured under the Maryland Medicaid program regardless of the child's area of residence. #### Regulation .04 Blood Tests for Lead Poisoning. *COMAR 10.11.04.04* A. A primary care provider for a child who resides, or who is known to have previously resided, in an at-risk area shall administer a blood test for lead poisoning during the 12-month visit and again during the 24-month visit. B. A primary care provider for a child who is 24 months old or older and younger than 6 years old who resides, or who is known to have previously resided, in an at-risk area as defined in the 2015 Targeting Plan for Areas at Risk for Childhood Lead Poisoning, shall administer a blood test for lead poisoning if the: (1) Child has not previously received a blood test for lead poisoning; (2) Child's parent or guardian fails to provide documentation that the child has previously received a blood test for lead poisoning; or (3) Provider is unable to obtain the results of a previous blood lead analysis. C. A primary care provider for a child shall administer a blood test for lead poisoning to a child if: (1) An affirmative answer, or a response indicating that the parent or guardian does not know the answer, is given for any question on a lead exposure risk questionnaire that is completed for the child pursuant to Regulation .03 of this chapter; or (2) The child's parent or guardian requests that the child receive a blood test for lead poisoning regardless of the child's age or area of residence. D. If a child is insured under Maryland's Medicaid program, the child's primary care provider shall administer a blood test for lead poisoning to the child at the 12-month visit and again at the 24-month visit in accordance with EPSDT requirements regardless of the child's area of residence. E. A primary care provider shall administer a blood test for lead poisoning, by venous methodology, if the results of a capillary blood test for lead poisoning indicate a blood lead level that exceeds the blood lead reference level. F. For each blood test for lead poisoning administered by a health care provider, the provider shall provide on the lab order form the information for blood lead reporting that is required under Environment Article, §6-303, Annotated Code of Maryland, to the medical laboratory that: (1) Draws the blood specimen; or (2) Performs the blood lead analysis. G. Physician offices and other point-of-care laboratories shall comply with the requirements under COMAR 10.10.03.02B(36) and C. H. Bona Fide Religious Beliefs — At Risk. (1) If the parent or guardian of a child refuses to consent to a blood test for lead poisoning due to the parent or guardian's stated bona fide religious beliefs and practices, a primary care provider shall: (a) Counsel the parent or guardian that the blood test for lead poisoning is required by law due to the fact that their child is at risk for having a blood lead level that exceeds the blood lead reference level; and (b) Complete a lead exposure risk questionnaire for the child in the presence of the child and the child's parent or guardian. (2) If an affirmative response to the questionnaire under §H(1)(b) of this regulation, or a response indicating that the parent or guardian does not know the answer, is entered for any question on the lead exposure risk questionnaire for the child, the provider shall: (a) Further counsel the parent or guardian regarding the risks of lead poisoning, including the potential physical, behavioral, developmental, and intellectual effects, and again request the parent or guardian to consent to a blood test for lead poisoning; (b) Document in the child's medical record any continued refusal by the parent or guardian to consent to a blood test for lead poisoning despite counseling, and the grounds for the parent or guardian's refusal; (c) Write and sign an order for a blood test for lead poisoning on a medical laboratory order form; and (d) Give the child's parent or guardian the completed order for the medical laboratory to draw a blood specimen for blood lead analysis. (3) If all the responses to the lead exposure risk questionnaire are negative, the provider shall: (a) Follow procedures set forth in §H(2)(b) of this regulation; and (b) Complete a form issued by the Department indicating that the questionnaire was completed. I. Repealed. J. This regulation does not limit the duties of the child's health care provider, with respect to any child who resides or has previously resided in an at-risk area, under any other provision of the law. K. A health care provider giving nonprimary care to a child may, but is not required to, administer a blood test for lead poisoning, even if a blood test for lead poisoning is not medically indicated. #### Regulation .05 Documentation Requirements on Entry into a Prekindergarten Program, Kindergarten Program, or First Grade. *COMAR 10.11.04.05* A. The parent or guardian of a child who currently resides, or has previously resided, in an at-risk area shall provide to the administrator of the child’s school or program, or the administrator’s designee, certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, on first entry into a: (1) Maryland public prekindergarten program; or (2) Maryland public school system at the level of prekindergarten, kindergarten or first grade. B. An electronic report of the child’s blood lead analysis from a health care provider to the administrator of the child’s school or program, or the administrator’s designee, may serve as an acceptable alternative to the documentation required in §A of this regulation. C. A health care provider shall: (1) Document and certify by signature the dates of the blood lead analysis administered to a child pursuant to Regulation .04A of this chapter on a form developed by the Department; and (2) Upon request by the child’s public school or program administrator, or the administrator’s designee, for a child who resides or has previously resided in an at-risk area, provide to the school or program the certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, in order to facilitate the Department’s public health surveillance activities relating to lead poisoning. D. The child’s parent or guardian shall provide certified documentation of the child’s blood lead analysis, as specified in §G of this regulation, administered in connection with the 12-month visit and 24-month visit to a Maryland public prekindergarten program not later than: (1) 20 calendar days from the 12-month visit or 24-month visit; or (2) 20 calendar days from first entry into the program or system. E. Pursuant to Regulation .04A of this chapter, if the child’s first blood test for lead poisoning was administered after the child is 24 months old, then only certified documentation of the most recent blood lead analysis is required to be reported pursuant to §C of this regulation. F. Pursuant to Regulation .04A of this chapter, if a child has more than two blood tests for lead poisoning done between the ages of 12 months and 24 months, then only certified documentation of the two most recent blood lead analyses shall be reported. G. The information sent to or received by a program or school pursuant to §A of this regulation shall be recorded and certified by a health care provider’s signature on a form issued by the Department that includes the following: (1) Name of the child; (2) Date and result of the blood lead analysis; and (3) The signature of the: (a) Child's primary care provider or designee; or (b) School health professional or designee that transcribed the information onto the form issued by the Department. H. If a child is not required to receive a blood test for lead poisoning pursuant to Regulation .04A or B of this chapter, then the child's parent or guardian shall provide to the administrator of the child's school or program, or the administrator's designee, on a form issued by the Department, documentation that the child does not reside and has never resided in an at-risk area. I. If a parent or guardian does not consent to a blood test for lead poisoning pursuant to Regulation .04H of this chapter, the child’s parent or guardian shall: (1) Take their child to a primary care provider for the provider to complete a lead poisoning risk assessment questionnaire; and (2) Submit to the administrator of the child's school or program, or the administrator's designee, a written, signed statement of exemption on a form issued by the Department. J. Notice Required. (1) The program or school shall give notice in accordance with §J(2) of this regulation to the parent or guardian of a child who resides or has resided in an at-risk area who does not provide: (a) The certified documentation of the child’s blood lead analysis, as specified in §G of this regulation; or (b) A signed statement of exemption. (2) The notice required under this section shall state that the parent or guardian is required by law to provide the information under §J(1) of this regulation at the time of enrollment. #### Regulation .06 Blood Lead Analysis Reporting Requirements. *COMAR 10.11.04.06* A. Notwithstanding §B of this regulation, a medical laboratory shall report, to the Department of the Environment, the information required under Environment Article, §6-303, Annotated Code of Maryland. B. A medical laboratory that performs blood lead analysis shall report the results of all blood tests for lead poisoning, performed pursuant to Regulation .04 of this chapter for a child who resides in Baltimore City, to the Commissioner of the Baltimore City Health Department in accordance with Article-Health, §4-607, Baltimore City Revised Code. C. The Commissioner of the Baltimore City Health Department may report the information received under §B of this regulation to the Baltimore Immunization Registry Program. D. The Department may report the results of blood lead analysis to an immunization registry developed by the Department. E. The Department of the Environment may report the results of blood lead analysis to an immunization registry developed by the Department. ### Chapter 05 — Child Death Review Case Reporting System **Authority:** Health-General Article, §§2-104(b) and 5-704, Annotated Code of Maryland **Administrative History:** Effective date: April 6, 2009 (36:7 Md R. 524) #### Regulation .01 Purpose. *COMAR 10.11.05.01* The purpose of this chapter is to clarify the authority of State and local child fatality review teams in Maryland to participate in certain national child death review case reporting systems as a means to enhance the CFR teams' ability to more effectively carry out its purpose of: A. Developing an understanding of the causes and incidence of child deaths; B. Developing plans for and implementing changes within the agencies represented on the child fatality review teams to prevent child deaths; and C. Advising the Governor, the General Assembly, and the public on changes to law, policy, and practice to prevent child deaths. #### Regulation .02 Scope. *COMAR 10.11.05.02* A. This chapter controls the drafting and implementation of data use agreements between the State child fatality review team and other public or private organizations or entities in order to assure that Maryland's State and local child fatality review teams are able to participate in and utilize recognized, appropriate national child death review case reporting systems in a secure manner that comports with applicable laws governing the confidentiality of child death information. B. This chapter governs the: (1) Maintenance of confidential child death review case data; (2) Participation of State and local child fatality review teams in national child death review reporting systems; and (3) Aggregation and reporting of de-identified child death data in the administration of Health-General Article, Title 5, Subtitle 7, Annotated Code of Maryland. #### Regulation .03 Definitions. *COMAR 10.11.05.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Child death review (CDR) case reporting system” means a national standardized, web-based reporting system for the confidential collection, analysis, aggregation, and reporting of child death data that is maintained and operated by a national center for child death review (NCCDR). (2) “Data use agreement” means a contract between the Department and a NCCDR that establishes the terms and conditions for the State and local CFR teams' participation in a child death review case reporting system. (3) “Department” means the Maryland Department of Health. (4) “Local child fatality review (CFR) team” means a multidisciplinary and multiagency review team established by a county under Health-General Article, §5-705, Annotated Code of Maryland. (5) “National center for child death review (NCCDR)” means a public, private, nonprofit, or governmental organization or entity that is: (a) Funded or otherwise recognized by the United States Department of Health and Human Services (DHHS); and (b) Responsible for: (i) Developing a CDR case reporting system; (ii) Training and serving as a liaison to State agencies participating in the system; and (iii) Disseminating national child death review data generated by the system. (6) “State Child Fatality Review (CFR) Team” means the State-level multidisciplinary and multiagency review team established under Health-General Article, §5-702, Annotated Code of Maryland. #### Regulation .04 Data Use Agreement. *COMAR 10.11.05.04* A. The Department may enter into a data use agreement with a NCCDR to participate in the NCCDR's case reporting system. B. The purpose of the data use agreement is to establish the terms and conditions for: (1) The confidential submission, collection, storage, and analysis of data obtained from the child death case reviews submitted by Maryland's State and local CFR teams; and (2) The reporting, aggregation, and dissemination of de-identified child death review data generated by the CDR case reporting system. #### Regulation .05 National Center for Child Death Review's Duties. *COMAR 10.11.05.05* The data use agreement with the NCCDR shall: A. Assure that the State and local CFR teams have full access to and use of the CDR reporting system for the purposes of collecting, analyzing, aggregating, and reporting on child death review data; B. Facilitate the comparison of aggregate, de-identified child death data within and among the State and local CFR teams; and C. Require that the NCCDR acts as a fiduciary agent of the State and local CFR teams in carrying out their responsibilities under this chapter. #### Regulation .06 Electronic Data Transmittal. *COMAR 10.11.05.06* Staff of the State or local CFR team shall first de-identify or remove information which would allow identification of an individual from any CFR team reports filed with, or information electronically transmitted by staff to, the NCCDR. #### Regulation .07 Confidentiality of Data. *COMAR 10.11.05.07* If any personally identifying child fatality review information or record is acquired by the NCCDR or its staff, that information or record is confidential and subject to the same confidentiality and discovery protections set forth in Health-General Article, §5-709, Annotated Code of Maryland, that apply to the State and local CFR teams. #### Regulation .08 Terms and Construction of a Data Use Agreement. *COMAR 10.11.05.08* Any data use agreement entered into by the State CFR Team and a NCCDR shall: A. Incorporate by reference and be construed in accordance with the provisions of Health-General Article, Title 5, Subtitle 7, Annotated Code of Maryland, and this chapter; and B. Be coexecuted by: (1) The Secretary or the Secretary's designee; and (2) The chairperson of the State CFR Team. ### Chapter 06 — Morbidity, Mortality, and Quality Review Committee — Pregnancy and Childhood **Authority:** Health-General Article, §18-107, Annotated Code of Maryland **Administrative History:** Effective date: September 21, 2009 (36:19 Md R. 1436) **Administrative History:** Regulation .02B amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .03 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .05 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .05B amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .06 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .07 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .08 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .09 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .10 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .11 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .12 amended effective April 23, 2018 (45:8 Md. R. 421) **Administrative History:** Regulation .13 amended effective April 23, 2018 (45:8 Md. R. 421) #### Regulation .01 Scope. *COMAR 10.11.06.01* This chapter does not apply to the review of a fetal death that is the result of a voluntary or therapeutic termination of pregnancy. #### Regulation .02 Definitions. *COMAR 10.11.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Committee” means the Morbidity, Mortality, and Quality Review Committee established within the Department. (2) “Department” means the Maryland Department of Health. (3) “Jurisdiction” means a political subdivision of the State, including the 23 counties and Baltimore City. (4) “Early childhood” means the period in which an individual is younger than 6 years old. (5) “Fetal and infant mortality review (FIMR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team established by a health officer or health officers of a group of jurisdictions. (6) “Fetal death” has the meaning stated in Health-General Article, §4-201, Annotated Code of Maryland. (7) “Health care provider” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland. (8) “Health officer” has the meaning stated in Health-General Article, §1-101, Annotated Code of Maryland. (9) “Infant death” means death occurring to an individual who is younger than 1 year old. (10) “Maryland Perinatal System Standards” means the hospital perinatal program standards established by the Perinatal Clinical Advisory Committee of the Department. (11) “Morbidity, mortality, and quality review (MMQR) team” means a local multidisciplinary and multiagency morbidity, mortality, and quality review team, or entity established to review cases associated with pregnancy, childbirth, infancy, or early childhood in order to make improvements in systems of care, including: (a) A fetal and infant mortality review team; or (b) Another multidisciplinary and multiagency review team or other entity established for a jurisdiction that addresses an aspect of morbidity, mortality, or quality of care associated with pregnancy, childbirth, infancy, or early childhood. (12) “Perinatal center” means a hospital that offers obstetric or neonatal services, or both. (13) “Secretary” means the Secretary of Health. (14) “Transport” means the transfer of a patient to another health care facility. #### Regulation .03 Incorporation by Reference. *COMAR 10.11.06.03* The Maryland Perinatal System Standards (Perinatal Clinical Advisory Committee, June 2014) is incorporated by reference. #### Regulation .04 Morbidity, Mortality, and Quality Review Committee. *COMAR 10.11.06.04* There is a Morbidity, Mortality, and Quality Review Committee established within the Department. #### Regulation .05 Membership. *COMAR 10.11.06.05* A. The Committee shall be: (1) A State-level multidisciplinary and multiagency review Committee within the Department; and (2) Composed of at least 26 members as described in §§B and C of this regulation. B. Ex Officio Members. The Committee shall include the following ex officio members or their designees: (1) The Secretary of the Maryland Department of Health; (2) The Secretary of Human Services; (3) The Deputy Secretary of the Health Care Financing Administration; (4) The Director of the Vital Statistics Administration; (5) The Director of the Prevention and Health Promotion Administration; (6) The Director of the Behavioral Health Administration; (7) The Director of the Maternal and Child Health Bureau; (8) The Chief Medical Examiner; (9) The Director of the Office of Minority Health and Health Disparities; (10) The Director of the Office of Health Care Quality; (11) The Executive Director of the Maryland Health Care Commission; (12) The Executive Director of the Maryland Institute for Emergency Medical Services Systems; (13) The Executive Director of the Medical and Chirurgical Faculty of Maryland; (14) The President of the Maryland Hospital Association; (15) The President of the Maryland Chapter of the American Academy of Pediatrics; (16) The Chair of the Maryland Section of the American College of Obstetricians and Gynecologists; (17) One representative from the University of Maryland School of Medicine; (18) One representative from the Johns Hopkins School of Medicine; (19) Three representatives from the Maryland Association of County Health Officers; (20) The Chair of the Maryland State Child Fatality Review Team; and (21) The Chair of the Maryland Maternal Mortality Review Committee. C. Appointed Members. (1) The Secretary shall appoint one Committee member that is a certified nurse midwife from a list of qualified individuals submitted by professional nursing organizations that represent licensed registered nurses in Maryland. (2) The Secretary may appoint up to five other Committee members and may appoint additional members who are individuals with an interest and expertise in pregnancy, childbirth, infancy, or early childhood or other related disciplines as considered necessary by the Secretary to carry out the Committee’s responsibilities. (3) Appointed Committee members shall serve at the pleasure of the Secretary. D. Designation of Representatives. An ex officio member described under §B of this regulation may designate another individual to represent the member on the Committee from the member’s: (1) Agency; (2) Department; (3) Office; or (4) Organization. E. Invitees. The Secretary may invite representatives from other agencies and organizations, and individuals involved in the prevention or reduction of morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood, to attend a Committee meeting if the representative has information that may be necessary to inform the Committee. F. Term of Appointment. Appointed members shall serve for a term of 3 years. G. Staffing. The Committee may employ staff in accordance with the State budget. H. Expenses. Members of the Committee shall serve without compensation, but may be reimbursed for reasonable expenses incurred in the performance of their duties: (1) In accordance with the standard State travel regulations; and (2) As provided in the State budget. I. Chairperson. The Secretary or the Secretary's designee shall serve as Chairperson of the Committee. #### Regulation .06 Committee Duties. *COMAR 10.11.06.06* A. To achieve its purpose, the Committee shall: (1) Provide consultation to FIMR teams and other MMQR teams; (2) Conduct confidential and anonymous case reviews of morbidity and mortality associated with pregnancy, childbirth, infancy, and early childhood; (3) Undertake annual statistical analysis of the incidence and cause of morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood; (4) Monitor hospital compliance with the Maryland Perinatal System Standards by: (a) Reviewing documents requested of the hospital in writing or by conducting on-site reviews, or by both; and (b) Making recommendations to improve or facilitate compliance; and (5) Determine factors contributing to morbidity and mortality, and make recommendations for strategies to prevent and reduce morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood throughout the State, including recommendations for changes to law, policy, or practice to prevent and reduce morbidity and mortality and improve the system of care. B. The Committee may: (1) Evaluate the continued effectiveness and efficiency of the Statewide morbidity, mortality, and quality review process associated with pregnancy, childbirth, infancy, and early childhood and make or recommend appropriate changes as necessary; (2) Establish special panels or ad hoc subcommittees of the Committee as necessary to carry out the duties of the Committee; (3) Analyze data and review reports or other information from: (a) FIMR teams; (b) Other MMQR teams; or (c) Other entities which are established for the purpose of addressing an aspect of morbidity, mortality, or quality reviews associated with pregnancy, childbirth, infancy, or early childhood; (4) Develop protocols for data collection regarding morbidity and mortality related to pregnancy, childbirth, infancy, and early childhood; (5) Examine the policies and procedures of State and local agencies, hospitals, and other entities that participate in the system of care; (6) Review specific cases regarding pregnancy, childbirth, infancy, or early childhood that the Committee considers necessary to perform its duties; and (7) Coordinate its activities with other State agencies in order to avoid unnecessary duplication of effort. #### Regulation .07 Local Teams — Establishment and Purpose. *COMAR 10.11.06.07* A. A jurisdiction shall have a multidisciplinary and multiagency FIMR team or other MMQR team. B. The purpose of a FIMR team is to facilitate the reduction of fetal and infant deaths by: (1) Conducting confidential case reviews of fetal and infant deaths including the examination of available medical and healthcare information involving fetal and infant mortality; and (2) Based on the findings of the case reviews conducted under §B(1) of this regulation: (a) Determining factors contributing to fetal and infant deaths; (b) Developing recommendations to reduce factors contributing to fetal and infant deaths; (c) Recommending strategies to improve the system of care in an effort to prevent or reduce fetal and infant deaths; and (d) Informing the Committee of changes that affect fetal and infant deaths in: (i) Local law; (ii) Policy; or (iii) Practices. C. A FIMR team shall: (1) Analyze fetal and infant deaths to determine contributing system factors; and (2) Make recommendations for systems change as appropriate. D. A FIMR team may: (1) Evaluate the continued effectiveness and efficiency of the local fetal and infant mortality review process and make appropriate changes; and (2) Establish protocols in compliance with State statutes and regulations, as applicable, for: (a) Data collection; (b) Analysis; and (c) Reporting. #### Regulation .08 FIMR Teams — Membership. *COMAR 10.11.06.08* A. Members of a FIMR team shall be appointed by the local health officer of the jurisdiction or be jointly appointed by the health officers of the jurisdictions comprising the multi-jurisdiction local team. B. A FIMR team shall appoint a chairman from among its membership. C. A FIMR team shall be multidisciplinary and include professionals and representatives of agencies that provide services or community resources for families in the community and community representatives. D. A FIMR team shall include at least one representative from: (1) Public health programs, such as: (a) Maternal and child health; (b) Substance abuse; or (c) Mental health; (2) Health care provider specialties, such as: (a) Obstetrics; (b) Pediatrics; (c) Social work; (d) Nursing; or (e) Nurse midwifery; and (3) Hospitals, such as hospital administrators, or professionals with expertise in perinatal services or quality improvement. E. A FIMR team may include representatives from other agencies or community organizations involved with the prevention or reduction of fetal and infant deaths. #### Regulation .09 MMQR Teams — General. *COMAR 10.11.06.09* MMQR teams may: A. Inform the Committee of changes that affect morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood in: (1) Local law; (2) Policy; or (3) Practice; and B. Provide the Committee with requested reports and other information so that the Committee may perform its duties. #### Regulation .10 Types of Committee Reviews. *COMAR 10.11.06.10* The Committee may conduct morbidity, mortality, and quality reviews associated with pregnancy, childbirth, infancy, and early childhood, including but not limited to reviews of the following: A. Individual cases or clusters of cases of morbidity or mortality; B. Maternal or neonatal transport to or from perinatal centers; and C. Aggregate or hospital-specific cases of mortality or morbidity associated with pregnancy, childbirth, infancy, or early childhood. #### Regulation .11 Access to Records and Information. *COMAR 10.11.06.11* A. A health care provider, hospital, HIPAA (Health Insurance Portability and Accountability Act of 1996) business associate, or other related entity shall, on written request of the Committee, FIMR team, other MMQR team, or their staff, provide access to records concerning: (1) Prepregnancy, prenatal, and postpartum care of the mother; (2) Somatic, dental, and behavioral health of the mother; (3) The health care provided by: (a) A health care provider; (b) A health care facility; or (c) Emergency medical services; (4) Emergency medical services system data on maternal and neonatal transport; (5) State vital records data related to morbidity or mortality associated with pregnancy, childbirth, infancy, or early childhood; and (6) Documentation relevant to the purpose and duties of the Committee, FIMR team, or other MMQR team that is maintained by a State or local government agency, including: (a) Medical examiner investigative information; and (b) Law enforcement investigative information, including police reports. B. The Committee, FIMR team, or other MMQR team shall assign staff to abstract information from patient medical records and other sources of information to which the Committee, FIMR teams, or other MMQR teams are entitled under §A of this regulation. C. Information abstracted under §B of this regulation shall be de-identified by the abstractor to remove information that would permit the identification of an individual health care recipient before the information may be used to carry out the purpose and duties of the Committee, FIMR team, or other MMQR team. #### Regulation .12 Meetings. *COMAR 10.11.06.12* A. The Committee shall meet at least semiannually. B. FIMR teams shall meet at least quarterly. C. A meeting of the Committee, FIMR teams, or other MMQR teams shall be closed to the public and is not subject to General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland, when the Committee, local FIMR team, or other MMQR team is reviewing cases of pregnancy, childbirth, infancy, or early childhood. D. The Committee, FIMR team, or other MMQR team may invite an individual who is not a member to attend a Committee, FIMR team, or other MMQR team meeting if: (1) The attendance is approved in advance by the Committee, FIMR team, or other MMQR team chairperson; (2) Participation of the invited individual is intended to assist the Committee, FIMR team, or other MMQR team in carrying out its duties; and (3) Invitees in attendance abide by the same confidentiality and nondisclosure requirements which govern the Committee, FIMR team, and other MMQR team members. #### Regulation .13 Confidentiality of Records and Information. *COMAR 10.11.06.13* A. The following shall be held confidential and may not be released to a person except as provided in this chapter: (1) Records and information received by the Committee, FIMR team, or other MMQR team; (2) Documents produced in the case review process; and (3) Minutes of meetings of the Committee, FIMR team, or other MMQR team. B. Information and records obtained by the Committee, a FIMR team, or other MMQR team are exempt from disclosure under General Provisions Article, Title 4, Annotated Code of Maryland. C. The Committee, a FIMR team, or other MMQR team may not discuss, disclose, or use information for purposes other than as necessary to carry out the Committee’s, FIMR team’s, or other MMQR team’s duties and purposes under this chapter. D. Information that is disclosed to the public by the Committee, FIMR team, or other MMQR team shall be de-identified and may not contain information that would permit the identification of an individual, a health care provider, or a health care facility. E. The Committee, a FIMR team, or other MMQR team may release specific findings that relate to aggregate data as well as recommendations made by the Committee, FIMR team, or other MMQR team to prevent and reduce morbidity and mortality, and this information shall be public record. F. The Committee, FIMR team, other MMQR team, or their staff shall maintain the confidentiality of information used or addressed at meetings. G. A person in attendance at a meeting of the Committee, a FIMR team, or other MMQR team may not testify or be required to testify as to what transpired at that part of the meeting that is closed under General Provisions Article, Title 3, Subtitle 3, Annotated Code of Maryland. H. A member of the Committee, FIMR team, other MMQR team, their staff, or invitees may not be questioned in a civil or criminal proceeding regarding information presented at or opinions formed as a result of a closed Committee, FIMR team, or other MMQR team meeting. I. A member of the Committee, FIMR team, other MMQR team, their staff, or invitees, may testify in a civil or criminal proceeding to information that is: (1) Obtained independent of the Committee, FIMR team, or other MMQR team; and (2) Publicly available, except as otherwise provided by law. J. Information, documents, and records of the Committee, a FIMR team, or other MMQR team are not subject, in a civil or criminal proceeding, to: (1) Subpoena; (2) Discovery; or (3) Introduction as evidence. K. Information, documents, and records obtained by the Committee, a FIMR team, or other MMQR team that are available from other sources may be subject, as provided by applicable law, to: (1) Subpoena; (2) Discovery; or (3) Introduction into evidence. L. A person may not be held liable for civil damages or subject to a criminal or disciplinary action for good faith efforts made to comply with the provisions of this chapter. ### Chapter 07 — Prohibition of Sale of Baby Bumper Pads **Authority:** Health-General Article, §22-501 et seq., Annotated Code of Maryland **Administrative History:** Effective date: November 26, 2012 (39:23 Md R. 1532) #### Regulation .01 Definitions. *COMAR 10.11.07.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ASTM Standards” means the standard consumer safety performance specifications for infant bedding and related accessories set by the American Society for Testing and Materials (ASTM). (2) “Baby bumper pads” means a pad or pads of non-mesh material resting directly above the mattress in a crib, running the circumference of the crib or along the length of any of the interior sides of the crib, and intended to be used until the age that an infant pulls to stand. (3) “Department” means the Maryland Department of Health. (4) “Hazardous material” has the meaning stated in Health-General Article, §22-501, Annotated Code of Maryland. #### Regulation .02 General Provisions. *COMAR 10.11.07.02* A. Baby bumper pads are hereby declared to be a hazardous material and may not be shipped or sold to a purchaser in Maryland beginning June 21, 2013. B. ASTM Standards. (1) After notification that ASTM has adopted a new voluntary standard for baby bumper pads, the Secretary may provide an opportunity for public comment on whether the new ASTM Standards should replace the prohibition contained in §A of this regulation. (2) Within 60 days after the close of public comment, the Secretary may issue an order permitting the sale of baby bumper pads that comply with the new ASTM Standards if the Secretary determines that such bumper pads are not a danger to the public health and safety. C. The Secretary may issue an order suspending this chapter for covered baby bumper pads if the Consumer Product Safety Commission affirmatively finds that the benefits of certain baby bumper pads exceed the risks. #### Regulation .03 Violations. *COMAR 10.11.07.03* A. A notice of violation will be issued by the Department to any person found to have shipped or sold a baby bumper pad to a purchaser in Maryland after June 21, 2013. B. A person who, after being issued a notice of violation, ships or sells a baby bumper pad to a purchaser in Maryland shall be subject to a civil fine of not more than $500 for each baby bumper pad shipped or sold in violation of this subtitle. ### Chapter 08 — Sensitive Health Services **Authority:** Health-General Article, §4-302.5 Annotated Code of Maryland **Administrative History:** Effective date: September 16, 2024 (51:18 Md. R. 809) **Administrative History:** Regulation .01B amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .02B amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .04B amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .06 recodified to Regulation .07 effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .06 adopted effective May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Purpose. *COMAR 10.11.08.01* This chapter: A. Defines: (1) Mifepristone data; (2) Health information exchange; (3) Electronic health network; and (4) Protected Health Care Commission; B. Lists the: (1) Mifepristone data, and diagnosis, procedure, and related codes for abortion care that are subject to the restrictions on the disclosure of health care information; and (2) Diagnosis, procedure, and related codes for gender-affirming treatment that are subject to the restrictions on the disclosure of health care information; C. Describes to whom these restrictions apply; and D. Sets forth the restrictions on data. #### Regulation .02 Definitions. *COMAR 10.11.08.02* A. In this chapter, the following terms have the meaning indicated. B. Terms Defined. (1) “Electronic health network” has the meaning stated in COMAR 10.25.09.02. (2) “Gender-affirming treatment” has the meaning stated in Health-General Article, §15-151, Annotated Code of Maryland. (3) “Health information exchange” has the meaning stated in COMAR 10.25.18.02. (4) “Mifepristone data” means all medication or related codes pertaining to mifepristone use during any stage of pregnancy, and excludes any codes pertaining to the use of mifepristone for Cushing’s syndrome. (5) “Protected Health Care Commission” means the group established under Health-General Article, §4-310, Annotated Code of Maryland. (6) “Secretary” means the Secretary of the Maryland Department of Health. #### Regulation .03 Abortion Care Codes. *COMAR 10.11.08.03* A health information exchange and an electronic health network shall restrict the disclosure of the abortion care medical diagnosis codes and current procedural terminology (CPT) codes listed in the tables below. A. List of Medical Diagnosis Codes. B. List of the Current Procedural Terminology (CPT®) Codes. #### Regulation .04 Mifepristone Data Codes. *COMAR 10.11.08.04* A health information exchange and an electronic health network shall restrict the disclosure of mifepristone data Healthcare Common Procedure Coding System (HCPCS) codes and medication codes listed in the tables below. A. List of Healthcare Common Procedure Coding System ( HCPCS) Level 2 Codes. B. List of Medication Codes. #### Regulation .05 Restrictions on Disclosure of Mifepristone Data. *COMAR 10.11.08.05* Data is restricted in accordance with COMAR 10.25.18 and COMAR 10.25.07. #### Regulation .06 Gender-Affirming Treatment Codes. *COMAR 10.11.08.06* A. A health information exchange and an electronic health network shall restrict the disclosure of the gender-affirming treatment medical diagnosis codes and current procedural terminology (CPT) codes listed in §B below. B. List of Medical Diagnosis Codes. #### Regulation .07 Sensitive Health Services. *COMAR 10.11.08.07* The Secretary shall determine what sensitive health services are subject to restriction under this chapter based on the recommendations of the Protected Health Care Commission. ## Subtitle 12 — Adult Health ### Chapter 01 — Surgical Abortion Facilities **Authority:** Health-General Article, §20-209, Annotated Code of Maryland **Administrative History:** Effective date: July 23, 2012 (39:14 Md. R. 835) #### Regulation .01 Definitions. *COMAR 10.12.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Facility” means a surgical abortion facility. (3) Health Professional. (a) “Health professional” means an individual who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services. (b) “Health professional” does not include a physician. (4) “Physician” means an individual licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland. (5) “Regular service” means that surgical abortion procedures are performed on site on a routine basis. (6) “Surgical abortion facility” means an outpatient facility that provides surgical termination of pregnancy as a regular service except if the facility is regulated by the Department under: (a) Health General Article, Title 19, Subtitle 3, Annotated Code of Maryland; (b) Health General Article, Title 19, Subtitle 3A, Annotated Code of Maryland; or (c) Health General Article, Title 19, Subtitle 3B, Annotated Code of Maryland. #### Regulation .02 License Required. *COMAR 10.12.01.02* A. A person may not establish or operate a surgical abortion facility without obtaining a license from the Secretary. B. License Period. A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary. C. A license issued under this chapter is not transferable. #### Regulation .03 Licensing Procedures. *COMAR 10.12.01.03* A. A person desiring to operate a facility shall: (1) Be in compliance with all applicable federal and State laws and regulations; (2) File an application as required and provided by the Department; and (3) Submit a written description of its quality assurance program as required by Regulation .16 of this chapter. B. In addition to meeting all of the requirements of Regulation .03A and F of this chapter, the applicant or licensee shall submit a nonrefundable fee of $1,500 with an application for: (1) An initial license; or (2) A license renewal. C. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: (1) Approve the application unconditionally; (2) Approve the application conditionally; or (3) Deny the application if the applicant: (a) Has been found liable for or has been convicted of: (i) Fraud or a felony that relates to Medicaid or Medicare; or (ii) A crime involving moral turpitude; or (b) Does not comply with the requirements of this chapter. D. Denial of License for Prior Revocation or Consent to Surrender License. (1) The Secretary may deny a license to: (a) A corporate applicant if the corporate entity has an owner, director, or officer: (i) Whose conduct caused the revocation of a prior license; or (ii) Who held the same or similar position in another corporate entity which had its license revoked; (b) An individual applicant: (i) Whose conduct caused the revocation of a prior license; or (ii) Who held a position as owner, director, or officer in a corporate entity which had its license revoked; or (c) An individual or corporate applicant that has consented to surrender a license as a result of a license revocation action. (2) The Secretary shall also consider the factors identified in Regulation .19B of this chapter when deciding whether to deny a license. E. A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter. F. Renewal of License. (1) At least 60 days before a license expires, the licensee shall submit to the Secretary: (a) A renewal application; and (b) The fee as specified in §B of this regulation. (2) The Secretary shall renew the license for an additional 3-year period for a licensee that meets the requirements of this chapter. #### Regulation .04 Inspections by the Department. *COMAR 10.12.01.04* A. Open for Inspection. A licensed facility or an entity proposing to operate such a facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Department to: (1) Verify compliance with this chapter; and (2) Investigate a complaint concerning patient care and safety as described in §B of this chapter. B. Complaints. (1) In response to a complaint, the Department may: (a) Require the facility to perform and submit its own investigation; or (b) In its discretion, conduct an on-site investigation of a complaint. (2) In order to determine whether an on-site investigation as described in §B(1)(b) of this regulation is appropriate, the factors the Department shall consider include, but are not limited to: (a) Whether the complainant has first-hand knowledge of the alleged incident; (b) The facility's regulatory history, including the number of verified prior complaints; (c) Whether the Department has recently inspected the facility, and whether the incident would have been observed during the prior review; and (d) The nature of the complaint, including degree of potential serious harm to patients. (3) If the complaint concerns the performance of a physician, health professional, or standards of practice, the Department shall refer the complaint to the board that licenses, certifies, or otherwise authorizes the physician or health professional to provide services under Health Occupations Article, Annotated Code of Maryland. (4) The Department shall: (a) Comply with the requirements for medical review committees as described in Health Occupations Article, §1-401, Annotated Code of Maryland; and (b) Keep patient information confidential in accordance with State and federal laws. C. Noncompliance. If the Department determines that a facility fails to meet any provision of this chapter, the Department shall: (1) Advise the facility of the exact nature of the violation; and (2) Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action. D. Records and Reports. The facility shall make its records and reports available to the Department on site at the facility during an inspection. #### Regulation .05 Administration. *COMAR 10.12.01.05* A. Administrator. (1) Each facility shall have an administrator, who is responsible for the daily operation of the facility, including but not limited to: (a) Consulting with the staff to develop and implement the facility's policies and procedures required under §C of this regulation; (b) Organizing and coordinating the administrative functions of the facility; (c) Coordinating the provision of services that the facility provides; (d) Training the staff on the facility's policies and procedures and applicable federal, State, and local laws and regulations; and (e) Ensuring that all personnel: (i) Receive orientation and have experience sufficient to demonstrate competency to perform assigned patient care duties, including proper infection control practices; (ii) Are licensed or certified by an appropriate occupational licensing board to practice in this State, if required by law; and (iii) Perform or delegate duties and responsibilities in accordance with standards of practice as defined by the Health Occupations Article, Annotated Code of Maryland. (2) The administrator shall ensure that: (a) The facility's policies and procedures as described in §C of this regulation are: (i) Reviewed by staff at least annually and are revised as necessary; and (ii) Available at all times for staff inspection and reference; and (b) All appropriate personnel implement all policies and procedures as adopted. B. Medical Director. (1) The surgical abortion facility shall have a medical director who: (a) Is responsible for the overall medical care that is provided by the facility; and (b) Advises and consults with the staff of the facility on all medical issues relating to services provided by the facility. (2) The medical director shall be a physician licensed to practice in Maryland. C. Policies and Procedures. The facility shall have policies and procedures concerning the following: (1) The scope and delivery of services provided by the facility either directly or through contractual arrangements; (2) Personnel practices, including but not limited to: (a) Procedures for the accountability of personnel involved in patient care; (b) Job descriptions on file for all personnel: and (c) Procedures to ensure personnel are free from communicable diseases; (3) Postoperative recovery, if applicable; (4) The transfer or referral of patients who require services that are not provided by the facility; (5) Infection control for patients and staff; (6) Pertinent safety practices, including the control of fire and mechanical hazards; (7) Preventive maintenance for equipment to ensure proper operation and safety; and (8) The services and procedures specified in Regulations .07—.12 of this chapter. #### Regulation .06 Personnel. *COMAR 10.12.01.06* A. Qualifications of Physicians and Staff. A facility shall ensure that all physicians and other health professionals who are employees or contractual staff have been appropriately trained and licensed or certified under the Health Occupations Article, Annotated Code of Maryland. B. Credentialing of Physicians. The facility shall collect, review, and document the following information concerning a physician licensed under Health Occupations Article, Title 14, Annotated Code of Maryland: (1) The physician's education; (2) The professional experience of the physician, including: (a) Any board certification or specialty training of the physician; and (b) Any post-graduate training; (3) Any license or registration to practice a health occupation ever held by the physician, including DEA registration; (4) Any hospital where the physician was appointed or employed during the last 10 years, including: (a) The name of the hospital; (b) The term of appointment or employment; and (c) Privileges held and any disciplinary action taken, including suspension, revocation, limitation, or voluntary surrender; (5) The physician's professional liability insurance for the last 5 years, including: (a) The physician's present carrier; (b) The physician's current limits of coverage; (c) The physician's current types of coverage; and (d) Restrictions on the physician's coverage; (6) Any claim that has been made against the physician in the practice of a health occupation in the last 5 years, and the status of the claim; (7) Any physical or mental condition that currently impairs the physician's ability to exercise privileges; (8) Any complaint or report, permitted to be disclosed by law, which has been filed with any state licensing or disciplinary body, or comparable body of the armed forces; and (9) Data provided by the National Practitioner Data Bank. C. For a physician who has privileges in a licensed Maryland hospital, the administrator may verify, through the hospital, the credentials described in §B of this regulation. D. The administrator shall establish a procedure for the biennial reappointment of a physician which includes: (1) An update of the information required in §B of this regulation; and (2) An assessment of the physician's performance pattern based on an analysis of: (a) Complaints filed with the facility; (b) Malpractice claims filed; (c) Utilization, quality, and risk data; (d) Adherence to policies, bylaws, and procedures; and (e) Physician practice patterns as reviewed through the facility's quality assurance program. E. Credentialing of Health Professionals. (1) Direct Hires. (a) The facility shall collect, review, and verify evidence of the following information for all licensed or certified health professionals that are employed by the facility: (i) A current license or certificate to practice in this State; and (ii) Malpractice insurance, if required by the facility. (b) The administrator shall approve the delineation of services to be provided by the health professional. (2) Nondirect Hires. When a licensed physician uses a health professional to provide services at the facility, and that person is not employed by the facility, the licensed physician who employs the health professional is responsible for verifying the information required in §E(1) of this regulation. #### Regulation .07 Surgical Abortion Services. *COMAR 10.12.01.07* A. Surgical abortion procedures shall be performed in a safe manner by a physician credentialed by the facility under Regulation .06 of this chapter. B. An administrator, in consultation with the medical director, shall develop and implement policies, procedures, and protocols for the provision of surgical abortion services including but not limited to: (1) Personnel; (2) Pre-operative testing and examinations; (3) Surgical procedures; (4) Post-anesthesia care and observation; (5) Discharge planning; (6) Emergency services; (7) Informed consent; and (8) Safety. C. The administrator shall ensure that the policies, procedures and protocols referenced in §B of this regulation are: (1) Available on site at all times for reference; and (2) Reviewed annually and revised as necessary. D. Before conducting a surgical procedure, a physician or other qualified health professional shall conduct a history and physical examination. E. If anything other than an unsupplemented local anesthetic is needed to accomplish a surgical procedure, a health practitioner as described in Regulation .08 of this chapter shall conduct a pre-anesthesia evaluation and document the anesthetic risk to the patient. F. If the assessments required by §§D and E of this regulation are performed before the day of surgery, on the day of surgery a physician or qualified health professional shall reassess and document on the patient’s medical record any change in the patient's clinical status that could have an effect on the surgical procedure to be performed and the anesthesia to be used. G. Discharge. Before discharge from the facility, the patient shall be evaluated by a physician or an appropriately trained health professional. This evaluation shall be documented in the patient’s record. #### Regulation .08 Anesthesia Services. *COMAR 10.12.01.08* A. Anesthetics shall be administered by health practitioners who are licensed, certified, or otherwise authorized to do so under the Health Occupations Article, Annotated Code of Maryland. B. Anesthetics shall be administered only by a: (1) Qualified anesthesiologist; (2) A physician qualified to administer anesthesia; or (3) A certified registered nurse anesthetist in accordance with: (a) Health Occupations Article, §8-205, Annotated Code of Maryland; and (b) COMAR 10.27.06. #### Regulation .09 Emergency Services. *COMAR 10.12.01.09* A. Basic Life Support. Licensed personnel employed by the facility shall have certification in basic life support. A licensed staff individual trained in basic life support shall be on duty whenever there is a patient in the facility. B. The facility shall have: (1) A registered nurse available on site for emergency treatment whenever there is a post-operative surgical abortion patient in the facility; and (2) At least one physician available by phone 24 hours a day to respond to emergency situations. C. When sedation or general anesthesia is administered, the facility shall have at least the following emergency equipment available to the procedure rooms: (1) Oxygen; (2) Mechanical ventilatory assistance including airways and manual breathing bag; (3) Automated external defibrillator (AED); (4) Equipment to monitor blood pressure, pulse, and oxygen levels; (5) Suction equipment; and (6) Emergency medical equipment and supplies specified by the medical staff. D. When general anesthesia is administered, a facility shall have available in the procedure room: (1) Laryngoscopes; (2) Endotracheal tubes; and (3) Cardiac monitoring equipment. #### Regulation .10 Hospitalization. *COMAR 10.12.01.10* A. The surgical abortion facility shall have an effective procedure for the transfer of patients to a nearby hospital when care beyond the capabilities of the facility is required. B. Procedures for emergency transfer to a hospital shall include, at a minimum: (1) Written protocols and procedures related to emergency transfer procedures; (2) A mechanism for notifying the hospital of a pending emergency case; (3) A mechanism for arranging appropriate transportation to the hospital; (4) Protocols for transmitting a copy of the patient's medical record to the hospital; and (5) Appropriate training for staff in the facility’s written protocols and procedures. #### Regulation .11 Pharmaceutical Services. *COMAR 10.12.01.11* A. The surgical abortion facility shall: (1) Provide drugs under the direction of an authorized prescriber; and (2) Develop and implement policies and procedures for pharmacy services in accordance with accepted professional practice. B. Administration of Drugs. (1) Staff shall prepare and administer drugs according to established policies and acceptable standards of practice. (2) Staff shall report adverse drug reactions to the licensee's medical director or physician. (3) Orders given orally for drugs shall be followed by a written order which is signed by the authorized prescriber. #### Regulation .12 Laboratory and Radiologic Services. *COMAR 10.12.01.12* A. The administrator shall develop and implement policies and procedures for obtaining routine and emergency laboratory and radiological services to meet the needs of the patient. Policies and procedures shall include: (1) Turn-around time; (2) Review of laboratory reports; and (3) Documentation of laboratory results. B. Laboratory facilities shall be: (1) Approved under the Clinical Laboratory Improvement Act (CLIA); and (2) Licensed by the State under COMAR 10.10.03. C. The facility shall include in the patient's medical records: (1) Laboratory reports; and (2) Radiological findings. #### Regulation .13 Medical Records. *COMAR 10.12.01.13* A. The facility shall maintain a complete, comprehensive, and accurate medical record for a patient. B. A patient's medical record shall include at least the following: (1) Patient identifier; (2) Significant medical history and results of a physical examination; (3) Documentation of care or services provided; (4) Evidence of consent; and (5) Discharge diagnosis. C. With the patient's consent or to the extent that information in a record is necessary for a patient's care in an emergency transfer, the facility shall: (1) Send a copy of the medical record with the patient on: (a) Referral to another physician or other licensed health professional; or (b) Transfer to a hospital; (2) If appropriate, and with the patient's consent, use the medical record when instructing the patient and the family; and (3) Comply with all disclosure requirements as set forth in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. #### Regulation .14 Patients’ Rights and Responsibilities *COMAR 10.12.01.14* The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients’ rights and responsibilities, including but not limited to: A. The opportunity to participate in planning their medical treatment; and B. Confidentiality of medical records and the right to approve or refuse release of records to any individual outside the facility, except as provided by federal or State law. #### Regulation .15 Physical Environment. *COMAR 10.12.01.15* A. The administrator shall ensure that the facility has a safe, functional, and sanitary environment for the provision of surgical services. B. A procedure room shall be designed and equipped to ensure that surgical abortion procedures conducted can be performed in a manner that ensures the safety of all individuals in the area. C. The facility shall have a separate recovery room and waiting area. D. The facility shall meet the requirements for handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06. #### Regulation .16 Quality Assurance Program. *COMAR 10.12.01.16* A. The administrator shall ensure that the facility develops and maintains a quality assurance program which includes: (1) Monitoring and evaluation of the quality of patient care; and (2) Identification, evaluation, and resolution of care problems. B. The facility shall conduct ongoing quality assurance activities and document the activities on a continuous basis, but not less than quarterly. C. The administrator shall ensure that the facility develops a quality control procedure to monitor and document the safety and performance of all biomedical equipment. D. The facility shall document the following information for all quality assurance activities: (1) A description of identified problems; (2) Findings; (3) Conclusions; (4) Recommendations; (5) Actions taken; (6) Results; and (7) Follow-up. #### Regulation .17 Emergency Suspension. *COMAR 10.12.01.17* A. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action. B. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is immediately suspended, the licensee shall: (1) Immediately return the license to the Department; and (2) Stop providing surgical abortion procedures immediately. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter. F. Hearing. (1) The Office on Administrative Hearings shall: (a) Conduct a hearing as set forth in Regulation .20 of this chapter; and (b) Issue a proposed decision within 10 business days of the close of the hearing record. (2) Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. G. Final Decision. (1) The Secretary shall make a final decision in accordance with COMAR 10.01.03. (2) If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. #### Regulation .18 Revocation of License. *COMAR 10.12.01.18* A. The Secretary, for cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested. B. The Secretary may revoke a license if the licensee: (1) Has been convicted of: (a) Fraud or a felony that relates to Medicaid or Medicare; or (b) A crime involving moral turpitude; or (2) Does not comply with the requirements of this chapter. C. The Secretary shall consider the factors identified in Regulation .19B of this chapter when deciding whether to revoke a license. D. The Secretary shall notify the licensee in writing of the following: (1) The effective date of the revocation; (2) The reason for the revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the revocation; (4) That the licensee is entitled to a hearing, if requested, and to be represented by counsel; (5) That the facility shall stop providing surgical abortion services on the effective date of the revocation if the licensee does not request a hearing; (6) That the revocation shall be stayed if a hearing is requested; and (7) That the licensee is required to surrender the license to the Department if the revocation is upheld. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter. #### Regulation .19 Penalties. *COMAR 10.12.01.19* A. Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter. B. When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors: (1) The number, nature, and seriousness of the violation or violations; (2) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; (4) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (5) Such other factors as justice may require. C. A person aggrieved by the action of the Secretary under §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .20 of this chapter. #### Regulation .20 Hearings. *COMAR 10.12.01.20* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, §§10-201—10-227, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35. ### Chapter 02 — Rape and Sexual Offenses — Physician and Hospital Charges **Authority:** Health-General Article, §§2-104(b) and 15-127, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.04 adopted as an emergency provision effective July 1, 1978 (5:14 Md. R. 1133), expired November 11, 1978; adopted permanently effective December 15, 1978 (5:25 Md. R. 1854) **Administrative History:** Regulations .01—.04 amended effective December 11, 1989 (16:24 Md. R. 2620) **Administrative History:** Regulation .01 amended effective March 2, 1992 (19:4 Md. R. 473) **Administrative History:** Regulation .02 amended effective March 2, 1992 (19:4 Md. R. 473) **Administrative History:** Regulation .03A amended effective March 2, 1992 (19:4 Md. R. 473) **Administrative History:** Regulations .03B and .04A, E, F amended effective November 14, 1980 (7:23 Md. R. 2166) **Administrative History:** Regulation .04 amended and recodified to Regulation .05 and new Regulation .04 adopted effective March 2, 1992 (19:4 Md. R. 473) **Administrative History:** Chapter revised effective July 5, 2004 (31:13 Md. R. 993) **Administrative History:** Regulation .03 amended effective December 29, 2008 (35:26 Md. R. 2249) **Administrative History:** Regulation .04B amended effective December 29, 2008 (35:26 Md. R. 2249) **Administrative History:** Regulation .05B, F amended effective December 29, 2008 (35:26 Md. R. 2249) #### Regulation .01 Scope. *COMAR 10.12.02.01* These regulations outline the requirements for the collection of evidence in cases of alleged rape, sexual offense, and child sexual abuse and for reimbursement to hospitals, laboratories, and physicians for the physical examination of, the collection of evidence from, and the emergency treatment of individuals for physical injuries directly resulting from the alleged rape or sexual assault and for an initial assessment, and information and evidence collection, of a victim of alleged child sexual abuse. #### Regulation .02 Definitions. *COMAR 10.12.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Child” means any individual younger than 18 years old. (2) “Department” means the Maryland Department of Health. (3) “Emergency hospital treatment” means the provision of those services which are medically necessary to treat the victim's physical health or alleviate the victim's severe pain or discomfort. (4) “Examination” means a medical examination, including the necessary tests, for the purpose of establishing and gathering information and evidence as to the alleged rape or sexual offense only. (4-1) “Forensic nurse examiner” means a registered nurse examiner certified by the Maryland Board of Nursing. (5) Initial Assessment. (a) “Initial assessment” means an appraisal for the purpose of establishing and gathering information and evidence as to alleged child sexual abuse. (b) “Initial assessment” includes a: (i) Psychological evaluation; (ii) Parental interview; and (iii) Medical evaluation. (6) “Interdisciplinary team expert in the field of child abuse” means a licensed physician, psychologist, social worker, nurse practitioner, nurse, or mental health professional working in a setting that specializes in child abuse. (7) “Mental health professional” means a board-eligible or board-certified psychiatrist, a licensed psychologist, or a person with a minimum of a master's degree and clinical training in an accepted mental health field, including the fields of counseling, nursing, occupational therapy, psychology, and social work. (8) “Physician” means a person licensed to practice medicine in Maryland. (9) “Provider” means a physician, hospital, or laboratory. (10) “Qualified hospital health care personnel” means a licensed employee of a hospital licensed by the State. (11) “Rape” means a criminal act of vaginal intercourse as defined under Criminal Law Article, §§3-303 and 304, Annotated Code of Maryland. (12) Sexual Abuse. (a) “Sexual abuse” means an act that involves sexual molestation or exploitation of a child whether or not the sexual molestation or exploitation of the child is by a parent or other person who has permanent or temporary care, or custody or responsibility for supervision of a child, or by a household or family member. (b) “Sexual abuse” includes, but is not limited to: (i) Incest, rape, or sexual offense in any degree; (ii) Sodomy; and (iii) Unnatural or perverted sexual practices. (13) “Sexual offense” means a criminal sexual act or sexual contact as defined under Criminal Law Article, §§3-305—3-308, Annotated Code of Maryland. (14) “Victim” means a person who is alleged to be the subject of rape, sexual offense, or child sexual abuse. #### Regulation .03 Alleged Rape or Sexual Offense Victim Care. *COMAR 10.12.02.03* A. The victim shall be considered an emergency patient with special needs. The victim shall be taken immediately to a quiet private area where tests and examinations will be performed on the victim. The following measures are indicated under certain circumstances: (1) Prophylactic medication shall be discussed and offered to the victim who is at risk for pregnancy as a result of the alleged rape or sexual assault; (2) Prophylactic medication shall be discussed and offered to the victim who is at risk for sexually transmitted infections and recommended initial tests and follow-up tests shall be performed, if indicated; (3) After the victim has been properly informed as to the significance of testing for the presence of the human immunodeficiency virus (HIV), the victim shall be referred to the appropriate anonymous or confidential, and free HIV counseling and test sites for potential baseline and follow-up testing and support services; (4) Injuries suffered by the victim shall be treated with appropriate consultation, as necessary; and (5) Tetanus prophylaxis may be administered, if indicated. B. Sexual Assault. (1) A sexual assault forensic examination shall be performed if: (a) The victim is seen within 120 hours of the alleged sexual offense; and (b) Either: (i) A police report has been filed with the appropriate law enforcement jurisdiction; or (ii) A property-held number is assigned to the case in the event that a victim does not wish to file a police report immediately but still seeks to have evidence collected and held. (2) A sexual assault forensic examination shall be performed only by a: (a) Physician; or (b) Forensic nurse examiner. (3) When performing a sexual assault forensic examination, a physician or a forensic nurse examiner shall use the Maryland State Police victim sexual assault evidence collection kit or a comparable evidence collection kit and shall follow the kit instructions including: (a) Packaging the victim's clothing in paper bags; and (b) Collecting the following specimens: (i) Blood sample (lavender cap); (ii) Vaginal swabs (a minimum of four); (iii) Oral swabs (a minimum of two); (iv) Pubic hair combings; (v) Pulled pubic hair; (vi) Pulled head hair; and (vii) If indicated, anal swabs, bite mark swabs, and fingernail scrapings. C. A physician or forensic nurse examiner shall follow the procedures as indicated to establish evidence of alleged rape or sexual offense, depending on the specifics of the crime as described by the victim: (1) Obtain from each of the following areas, if indicated, a smear to be fixed and stained according to the Papanicolaou technique: (a) Endocervical canal; (b) Vaginal pool; (c) Vulva; (d) Mouth; and (e) Anal area; (2) Obtain culture for gonorrhea from cervix, rectum, and nasopharynx, if indicated, and plate it immediately; (3) Obtain vaginal, oral, or rectal aspirate for acid phosphatase testing, if indicated; (4) Obtain a blood sample for syphillis testing and refer patient to a healthcare provider of choice for repeat sample in 4 — 6 weeks; (5) Obtain X-rays necessary to establish evidence of physical injuries sustained as a direct result of the alleged rape or sexual offense; and (6) Obtain either a urine sample or a blood sample for beta subunit of human chorionic gonadotropin for a pregnancy test and recommend and refer the victim to a healthcare provider of choice for a second test in 4—6 weeks, if indicated. D. A physician or forensic nurse examiner shall submit the evidence collected to the appropriate law enforcement jurisdiction. #### Regulation .04 Alleged Child Sexual Abuse Victim Care. *COMAR 10.12.02.04* A. The professional involved in the care of the victim of alleged child sexual abuse shall make every effort to minimize additional physical or emotional trauma to the child. B. The following protocol is recommended for the initial assessment: (1) A history of the child shall be obtained from the parent, guardian, or custodian separately from the child, if possible, and shall: (a) Minimize repetitive questioning of the child; (b) Recognize that the child is often threatened and afraid to tell; and (c) Include a review of behavior relevant to sexual abuse; (2) A physician or forensic nurse examiner shall perform a thorough pediatric physical examination on the child in the presence of a supportive adult not suspected of being party to the abuse and a physician or forensic nurse examiner shall: (a) Use gentleness, time, sedation, or general anesthesia if absolutely necessary; (b) Note evidence of physical abuse and injuries; (c) Avoid internal anogenital examinations except when internal injuries are suspected; (d) Perform a gender specific examination on the male child to include: (i) Examining thighs, penis, scrotum, testes, and anus for evidence of injury and infection, and (ii) Noting Tanner stage; (e) Perform a gender specific examination on the female child to include: (i) Examining thighs, labia majora and minora, clitoris, urethra, hymen and vaginal wall (especially posteriorly) for evidence of injury and infection and noting horizontal hymenal opening diameter; (ii) Maintaining a frog-leg position during the examination; and (iii) Noting Tanner stage; (f) Perform a routine pelvic examination on the postpubertal female child only if the victim has had a previous pelvic examination; (3) Depending on the specifics of the individual case and exercising best professional judgment, a physician or forensic nurse examiner may perform a rape examination if the child is seen within 120 hours of alleged sexual abuse, and the examination shall: (a) Include only applicable parts of the rape kit; and (b) Maintain the chain of custody of evidence; (4) The physician or forensic nurse examiner shall obtain laboratory tests when the tests are indicated from information obtained through the child's history or physical examination; (5) A psychological assessment shall include: (a) A review of what happened to the child from the child's perspective; (b) The use of play, dolls, or drawings as a way for the younger child to communicate what happened to the child; (c) An assessment of the effect of the alleged sexual abuse on the child; and (d) A developmentally age-appropriate description of the psychological findings and any indications for follow-up care; (6) An interview with a parent, guardian, or custodian shall include a: (a) Review from the parent's, guardian's, or custodian's understanding of the alleged child abuse; (b) Description of any behavioral manifestations that may be observed in the child such as fears, clinging, sleep disturbances, bed-wetting, somatic complaints, or school problems; and (c) Discussion of anticipated medical or investigative follow-up, or both, pursuant to Family Law Article, Title 5, Subtitle 7, Annotated Code of Maryland; (7) Professionals qualified to gather information and evidence as part of the initial assessment include: (a) A physician; (b) Qualified hospital health care personnel; (c) A mental health professional; and (d) An interdisciplinary team expert in the field of child abuse. #### Regulation .05 Reimbursements. *COMAR 10.12.02.05* A. Restrictions. A provider: (1) May not charge the victim or the victim's family of an alleged rape, sexual offense, or child sexual abuse for a physical examination or an initial assessment for the purpose of establishing and gathering information and evidence as to the alleged crime or for emergency hospital treatment and follow-up medical testing performed up to 90 days after the initial physical examination; (2) May not bill a victim of an alleged rape, sexual offense, or child sexual abuse, or the victim's family or private insurance, for any difference between charges and Department reimbursement; and (3) Shall accept the Department's reimbursement as payment in full. B. Physicians Providing Services to Victims of Alleged Rape or Sexual Offense. (1) The Department shall pay a physician the physician's usual and customary fee not to exceed $80 for examination and collection of evidence, if the following are submitted to the Maryland Department of Health, Center for Health Promotion, 300 West Preston Street, Suite # 410, Baltimore, MD 21201: (a) The forms found in the Maryland State Police sexual assault kit, or comparable evidence collection kit, which are: (i) Filled out completely; (ii) Typed or legibly written; (iii) Signed and dated by the examining physician; and (iv) Bearing the police central complaint number or a similar police case identifier or a property-held number in accordance with Regulation .03B(1)(b) of this chapter; and (b) A completed MDH form 2923, as developed by the Department, containing the signature of the victim or the victim's representative, indicating informed consent for medical examination, collection of evidence, and release of information. (2) The Department shall pay the physician's usual and customary fee for consultation and for rendering emergency hospital treatment and necessary follow-up medical testing obtained within 90 days of the initial physical examination, for injuries sustained as a result of alleged rape or sexual assault. (3) If there is a physician's fee component in the emergency room rate as established by the Health Services Cost Review Commission, there is no additional payment for the physician. C. Physicians Providing Services to Victims of Alleged Child Sexual Abuse. (1) The Department shall pay a physician the physician's usual and customary fee or the customary fee of those individuals under the physician's supervision, qualified to participate in the gathering of information and evidence through an initial assessment as defined under Regulation .02B of this chapter, not to exceed $80 per hour for up to 5 hours. The Department shall pay a physician only if a report: (a) Is filled out completely as to the assessment done; (b) Is typed or legibly written; (c) Is signed and dated by the physician or cosigned by the physician and other qualified professionals providing services; (d) Includes the police central complaint number, a property-held number, or other case identifier; and (e) Includes either a completed MDH Form 2923 or 4456, as developed by the Department. (2) If there is a physician's fee component in the emergency room or outpatient clinic rate as established by the Health Services Cost Review Commission, there is no additional payment for the physician. D. Hospital. The Department shall pay the established rate as determined by the Health Services Cost Review Commission for the use of the emergency room or outpatient clinic and the daily in-hospital rate in case of hospitalization for physical injuries directly resulting from the alleged sexual assault or abuse. E. Laboratory. The Department shall pay the established rate as defined by the Health Services Cost Review Commission for laboratory tests necessary to establish and gather information and evidence of the crime, and for screening of the victim for pregnancy and sexually transmitted infections. F. Billing. (1) Except as provided in §F(3) of this regulation, in order to get paid a provider shall submit itemized bills to the Department within 90 days of the rendering of care. (2) If a provider submits a bill more than 90 days but less than 180 days after the initial physical examination, the provider shall submit a written request for payment stating the specific reasons why the itemized bills were not timely submitted in accordance with §F(1) of this regulation. (3) The Department may pay bills received more than 90 days but less than 180 days after the initial physical examination if the Department determines that the provider has set forth a legitimate explanation for not submitting the bill within 90 days of rendering care. (4) To identify the alleged sexual offense, a bill submitted by a provider under this chapter shall contain: (a) A police central complaint number or other case identifier; or (b) A property-held number assigned in accordance with Regulation .03B(1)(b)(ii) of this chapter when there is no police central complaint number or similar police case identifier because a criminal prosecution is not being pursued. (5) The provider of services shall secure signed informed consent for examination and collection of evidence in cases of alleged rape or sexual offense with authorization for release of information on such forms as are developed by the Department. The providers shall supply the Department with any information requested concerning services rendered. G. Payment under this chapter is contingent on the availability of funds according to State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland. ### Chapter 03 — Cosmetic Surgical Facilities **Authority:** Health General Article, Title 19, Subtitle 3C, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 2015 (41:24 Md. R. 1427) **Administrative History:** Regulation .01B amended effective March 30, 2026 (53:6 Md. R. 291) #### Regulation .01 Definitions. *COMAR 10.12.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Cosmetic Surgical Facility. (a) “Cosmetic surgical facility” means an office or a facility in which a cosmetic surgical procedure is performed. (b) “Cosmetic surgical facility” does not include: (i) An ambulatory surgical facility; (ii) A hospital; or (iii) An office owned or operated by one or more dentists providing services within the scope of practice of dentistry. (2) Cosmetic Surgical Procedure. (a) “Cosmetic surgical procedure” means the use of surgical services to reshape the structure of a human body to change the appearance of an individual. (b) “Cosmetic surgical procedure” does not include: (i) A procedure done under local anesthesia or mild sedation; or (ii) Liposuction that removes less than 1,000 cubic centimeters of aspirate. (3) “Department” means the Maryland Department of Health. (4) “Facility” means a cosmetic surgical facility as defined in §B(1) of this regulation. (5) “Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession. (6) “License” means a document issued by the Secretary to a person to operate a cosmetic surgical facility. (7) “Licensee” means the person to whom a license is issued. (8) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (9) “Secretary” means the Secretary of Health or the Secretary's designee. #### Regulation .02 License Required. *COMAR 10.12.03.02* A. A person may not establish or operate a cosmetic surgical facility without obtaining a license from the Secretary. B. License Period and Fee. (1) A license is valid for 3 years from the date of issuance, unless suspended or revoked by the Secretary. (2) The applicant shall submit a nonrefundable fee of $3,000 for a 3-year period, with an application for initial licensure, or submit a nonrefundable fee of $3,000 with an application for license renewal for a 3-year period. C. A license issued under this chapter is not transferable. #### Regulation .03 Licensing Procedures. *COMAR 10.12.03.03* A. A person desiring to operate a facility shall: (1) Be in compliance with all applicable federal, State, and local laws and regulations and be accredited as a cosmetic surgical facility by: (a) The American Association for Accreditation of Ambulatory Surgical Facilities; (b) The Accreditation Association for Ambulatory Health Care; (c) The Joint Commission; or (d) An accreditation organization approved by the Secretary; or (2) Be certified to participate in the Medicare Program, as enacted in Title XVIII of the Social Security Act. B. In addition to the requirement of §A of this regulation, a person desiring to operate a facility shall: (1) File a complete application on a form provided by the Department; (2) Pay the licensure fee set forth in Regulation .02 of this chapter; and (3) Submit to an initial survey upon request by the Department. C. An officer of a corporation or association shall apply for a license on behalf of the entity. The owner shall apply on behalf of a sole proprietorship. An applicant shall submit the names of the entity's board members, owners, and investors having at least 2 percent ownership. D. An authorized individual of a government unit or agency shall apply for a license on behalf of the government unit or agency. E. Based on information provided to the Department by the applicant and the Department's own investigation, the Secretary shall: (1) Approve the application unconditionally if the applicant complies with all requirements of this chapter; (2) Approve the application conditionally; or (3) Deny the application if the applicant: (a) Has been convicted of: (i) A felony that relates to Medicaid or Medicare; or, (ii) A crime involving moral turpitude; or (b) Does not comply with the requirements of this chapter. F. Denial of License for Prior Revocation or Consent to Surrender License. The Secretary may deny a license to: (1) A corporate applicant if the corporate entity has an owner, director, officer, or other person with a substantial interest: (a) Whose conduct caused the revocation of a prior license; or (b) Who held the same or similar position in another corporate entity that had its license revoked; (2) An individual applicant: (a) Whose conduct caused the revocation of a prior license; or (b) Who held a position as owner, director, or officer in a corporate entity which had its license revoked; or (3) An individual or corporate applicant that has consented to surrender a license as a result of a license revocation action. G. The Secretary shall also consider the factors identified in Regulation .10C of this chapter when deciding whether to deny a license. H. A person aggrieved by a decision of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter. I. Renewal of License. (1) At least 60 days before a license expires, the licensee shall submit a renewal application to the Secretary. (2) The Secretary shall renew the license for an additional 3-year period for a licensee that meets the requirements of this chapter. J. Temporary License. (1) The Department shall issue a temporary license not to exceed 1 year to a facility that has filed an application to be: (a) Certified to participate in the Medicare Program, as enacted in Title XVIII of the Social Security Act; or (b) Accredited by: (i) The American Association for Accreditation of Ambulatory Surgical Facilities; (ii) The Accreditation Association for Ambulatory Health Care; (iii) The Joint Commission; or (iv) An accreditation organization approved by the Secretary. (2) The Department may extend the period for a temporary license beyond 1 year for good cause. (3) The Department shall issue a license to a facility once the facility has: (a) Received certification or accreditation; and (b) Met all the other requirements for licensure as a cosmetic surgical facility. (4) The Department shall void a temporary license upon receiving notice that the facility’s application for certification or accreditation has been denied. K. Transfer or Assignment of License Prohibited. If the sale, transfer, assignment, or lease of a cosmetic surgical facility causes a change in the person or persons who control or operate the facility, the Department shall consider the facility to be a new facility and the licensee shall conform to all regulations applicable at the time of transfer of operations. L. Return of License. The current license shall become void immediately and the licensee shall return the license to the Secretary if the facility: (1) Is sold or leased; (2) Ceases to operate; (3) Moves to a new permanent location; (4) Has had its Medicare Program certification or accreditation issued by an accreditation organization denied or revoked; or (5) Has its license denied, suspended or revoked. #### Regulation .04 Service Standards. *COMAR 10.12.03.04* A. The licensee is responsible for compliance with all laws and regulations applicable to the operation of a cosmetic surgical facility including a physician’s compliance with Health Occupations Article, §14-404(a)(41), Annotated Code of Maryland. B. Accreditation Standards. (1) The licensee shall meet the standards for the operation of a cosmetic surgical center issued by the licensee’s accreditation organization. (2) If a licensee loses its accreditation, the licensee shall immediately: (a) Cease operations; (b) Notify the Department; and (c) Return the license certificate to the Department. #### Regulation .05 Investigation by the Secretary. *COMAR 10.12.03.05* A. The Secretary may investigate complaints concerning the conformance of a cosmetic surgical facility to the requirements of this chapter and for compliance with the standards for the operation of a cosmetic surgical center issued by its accreditation organization. B. A facility shall be open during normal business hours, or any other times that the facility is serving patients, for inspection by the Department and by any other agency designated by the Secretary to investigate complaints. C. The Department shall refer complaints concerning a health care practitioner’s performance or a health care practitioner’s conformance to the standards of medical practice to the appropriate health occupations board that licenses, certifies, or otherwise regulates the health care practitioner under the Health Occupations Article, Annotated Code of Maryland. D. Noncompliance. (1) If the Secretary determines that a licensee fails to meet any provision of this chapter or fails to comply with the standards for the operation of a cosmetic surgical center issued by its accreditation organization, the Secretary shall: (a) Advise the licensee of the exact nature of the violation; and (b) Require that the facility specify what corrective action it is taking and monitor the facility to ensure that it takes corrective action. (2) This section does not preclude the Secretary from imposing any of the sanctions set forth in this chapter. (3) The Secretary may not require that a licensee correct a violation of a standard that is a higher standard than that required of an ambulatory surgical facility under Health-General Article, Title 19, Subtitle 3B, Annotated Code of Maryland, and its implementing regulations. E. Records and Reports. The facility shall make its records and reports available to the Department or its designee for inspection during the investigation of a complaint. On the written request of the Department, the facility shall immediately provide photocopies or electronic images of records and reports, including clinical records of patients. #### Regulation .06 Medical Records. *COMAR 10.12.03.06* A. The facility shall maintain a complete, comprehensive, and accurate medical record for a patient. B. A patient's medical record shall include at least the following: (1) Patient identifier; (2) Significant medical history and results of a physical examination; (3) Documentation of care or services provided; (4) Evidence of consent; and (5) Discharge diagnosis. C. The facility shall: (1) Send a copy of the medical record with the patient on referral to another health care provider or on transfer to a hospital; (2) Use the medical record, if appropriate, in instructing the patient and the family; and (3) Comply with all disclosure requirements as set forth in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. #### Regulation .07 Patients’ Rights. *COMAR 10.12.03.07* A. The administrator shall ensure that the facility develops and implements written policies and procedures concerning patients' rights and responsibilities. B. The facility shall make the policies and procedures available to patients, guardians, and other health care decision makers, as defined by Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and the public. C. The policies and procedures shall require that: (1) The facility informs patients of services that are available and the charges for services not covered by third-party payors; (2) A physician, dentist, podiatrist, or other qualified health care practitioner informs patients of their medical conditions unless medically contraindicated as documented in their medical records; (3) All patients are afforded an opportunity to participate in planning their medical treatments and to refuse to participate in experimental research; and (4) All patients are ensured confidential treatment of their medical records, and may approve or refuse release of records to any individual outside the facility, except as provided by federal or State law. #### Regulation .08 Physical Environment. *COMAR 10.12.03.08* A. The facility shall meet all federal, State, and local laws, ordinances, and regulations for construction. B. The facility shall meet all safety requirements of the National Fire Protection Association, NFPA 101 “Life Safety Code”, which is incorporated by reference at COMAR 29.06.01.06. C. The facility shall meet the requirements for the handling, treatment, and disposal of special medical wastes as provided in COMAR 10.06.06. #### Regulation .09 Emergency Suspension. *COMAR 10.12.03.09* A. The Secretary may immediately suspend a license on a finding that the public health, safety, or welfare requires emergency action. B. The Department shall deliver a written notice to the licensee: (1) Informing the licensee of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the licensee of the licensee's right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is immediately suspended, the licensee shall: (1) Immediately return the license certificate to the Department; and (2) Stop providing services immediately. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter. F. Hearing. (1) The Office of Administrative Hearings shall: (a) Conduct a hearing as set forth in Regulation .12 of this chapter; and (b) Issue a proposed decision within 10 business days of the close of the hearing record. (2) Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. G. Final Decision. (1) The Secretary shall make a final decision pursuant to COMAR 10.01.03. (2) If the Secretary's final decision does not uphold the emergency suspension, the licensee may resume operation. #### Regulation .10 Revocation of License. *COMAR 10.12.03.10* A. The Secretary, for good cause shown, shall notify the licensee of the Secretary's decision to revoke the facility's license. The revocation shall be stayed if a hearing is requested. B. The Secretary may revoke a license if the licensee: (1) Has been convicted of a: (a) Felony that relates to Medicaid or Medicare; or (b) Crime involving moral turpitude; (2) Does not comply with the requirements of this chapter; (3) Fails to comply with the standards for the operation of a cosmetic surgical facility issued by its accreditation organization; or (4) Engages in conduct that requires revocation to protect the public health, safety, or welfare. C. The Secretary shall also consider the following factors when deciding whether to revoke a license: (1) The number, nature, and seriousness of the violations; (2) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; (4) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (5) Such other factors as justice may require. D. The Secretary shall notify the licensee in writing of the following: (1) The effective date of the revocation; (2) The reason for the revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the revocation; (4) That the licensee is entitled to a hearing if requested, and to be represented by counsel; (5) That the facility shall stop providing services on the effective date of the revocation if the licensee does not request a hearing; (6) That the revocation shall be stayed if a hearing is requested; and (7) That the licensee is required to surrender the license to the Department if the revocation is upheld. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter. #### Regulation .11 Penalties. *COMAR 10.12.03.11* A. Administrative Penalty. The Secretary may impose an administrative penalty of up to $1,000 for a violation of any provision of this chapter. B. When considering whether to impose an administrative penalty and the amount of the penalty, the Secretary shall consider the following factors: (1) The number, nature, and seriousness of the violations; (2) The extent to which the violation or violations are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk, caused by the violation or violations, to the health, life, or safety of the patients of the facility; (4) The efforts made by, and the ability of, the licensee to correct the violation or violations in a timely manner; and (5) Such other factors as justice may require. C. A person aggrieved by the action of the Secretary under §A of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .12 of this chapter. #### Regulation .12 Hearings. *COMAR 10.12.03.12* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, §10-201 et seq., Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as set forth in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. F. The Secretary shall issue a final decision in accordance with COMAR 10.01.03.35. ### Chapter 04 — Day Care for the Elderly and Adults with a Medical Disability **Authority:** Health-General Article, §§2-104, 14-206, and 14-304; State Government Article, §10-226; Annotated Code of Maryland **Administrative History:** Effective date: January 12, 1979 (6:1 Md. R. 17) **Administrative History:** Regulations .01; .02B, E; .03A, C, D; .04A—E; .05A, G, H, L, M, N; .06A; .07A, C; .08B; .09C; and .11B, K amended effective July 11, 1980 (7:14 Md. R. 1350) **Administrative History:** Regulation .04F repealed effective July 11, 1980 (7:14 Md. R. 1350) **Administrative History:** Chapter recodified from COMAR 10.26.01 to COMAR 10.12.04 and Regulations .01, .02A, .04—.08, .09C, .10A, and .11A amended effective November 13, 1989 (16:22 Md. R. 2365) **Administrative History:** Regulation .02E amended effective July 5, 1993 (20:13 Md. R. 1049) **Administrative History:** Regulations .01—.12 repealed and new Regulations .01—.52 adopted effective November 23, 2006 (33:23 Md. R. 1795) **Administrative History:** Regulation .02B amended effective January 20, 2014 (41:1 Md. R. 13) **Administrative History:** Regulations .01—.52 repealed and new Regulations .01—.53 adopted effective December 13, 2014 (41:12 Md. R. 668) **Administrative History:** Regulation .04A amended effective December 21, 2015 (42:25 Md. R. 1543); August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .04C amended effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 Scope. *COMAR 10.12.04.01* A. This chapter applies to day care centers for the elderly and adults with a medical disability as defined in Health-General Article, Title 14, Subtitles 2 and 3, Annotated Code of Maryland. B. This chapter does not: (1) Affect a relative, domestic partner, neighbor, or friend who cares for an individual with a medical disability by mutual agreement; or (2) Apply to nutrition sites, senior centers under the auspices of the Department of Aging, or social model programs that individuals may attend to participate in meals or diversion activities. #### Regulation .02 Definitions. *COMAR 10.12.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities of daily living” means normal daily activities, including: (a) Eating or being fed; (b) Grooming, bathing, and oral hygiene; (c) Mobility, transfer, ambulation, and use of environmental aids to assist the individual to achieve greater independence; (d) Toileting; and (e) Dressing. (2) “Activities coordinator” means the individual assigned to develop and direct the activity program for the adult day care center. (3) “Actual harm deficiency” means: (a) A condition existing in a center; or (b) An action or inaction by the center staff that has caused physical or emotional injury or impairment to a participant. (4) “Adult Day Care Assessment and Planning System (ADCAPS)” means a system that is comprised of a comprehensive assessment completed by the RN, that is designed to evaluate the participant’s strengths and needs, which facilitates the development of a problem list, service plans, and personal goals that make up the individualized plan of care. (5) "Center" means any nonresidential program meeting the definition in Health-General Article, §14-201(b) or 14-301(b), Annotated Code of Maryland. (6) “Certified medication technician (CMT)” means an individual who is certified as a medication technician as defined in Health Occupations Article, §8-6A, Annotated Code of Maryland. (7) “Certified Nursing Assistant (CNA)” means an individual who is certified as a nursing assistant as defined in Health Occupations Article, §8-6A, Annotated Code of Maryland. (8) “Chemical restraint” means the use of a drug or medication that is not a standard treatment for a participant's condition to control or restrict the participant's movement (9) “Cognitively intact” means a participant who has sufficient judgment, planning, organization, self-control, and the persistence needed to manage the normal demands of the participant's environment. (10) “Communicable disease” has the meaning stated in COMAR 10.06.01.02 and 10.06.01.03. (11) “Deficiency” means a condition existing in a center, or an action or inaction by the center staff that result in the potential for more than minimal harm, actual harm, or serious and immediate threat to one or more participants. (12) “Department” means the Maryland Department of Health. (13) “Direct participant care” means day-to-day direct assistance to participants in accomplishing activities of daily living and in meeting health and psychosocial needs. (14) “Employee” means a full-time or part-time staff individual who works regular hours for pay. (15) “Existing center” means a center that is licensed by the Department or has its plans approved by the Department at the time of adoption of the regulations of this chapter. (16) “Full-time” means 40 hours per week or the standard workweek adopted by the center. (17) “Governing body” means the individual, partnership, agency, group, corporation, or other entity set up to assume full legal responsibility for the policy determination, management, operation, and financial liability of the center. (18) “Individual plan (IP)” means a document that specifies assessments, services, supports, and training required by the individual as specified in COMAR 10.22.05. (19) “Informal Dispute Resolution (IDR)” means an informal process that provides a licensee the opportunity to question the Department about deficiencies cited on a recent inspection. (20) "Health care provider” means an individual who is licensed, certified, or otherwise authorized under the Health Occupations Article to provide health care services. (21) “Licensed practical nurse (LPN)” means an individual: (a) Licensed to practice licensed practical nursing as defined in Health Occupations Article, §8-301, Annotated Code of Maryland; and (b) Whose practice is in accordance with the provisions of COMAR 10.27.10. (22) “Licensed social worker” means an individual who is licensed to practice social work as defined in Health Occupations Article, Annotated Code of Maryland. (23) “Mental illness” has the meaning stated in COMAR 10.09.70.10A. (24) “New center” means a center that does not have plans approved by the Department. (25) “Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Maryland Department of Health. (26) “Ongoing pattern” means the occurrence of any potential for more than minimal harm or greater deficiency on two consecutive on-site visits as a result of annual surveys, follow up visits, any unscheduled visits, or complaint investigations. (27) “Participant” means a health-impaired adult whose: (a) Illness or disability does not require 24-hour inpatient care; and (b) Needs cannot be satisfactorily met in an episodic ambulatory care setting but require at least 1 day of care per week in a day care program. (28) “Part-time” means less than full-time. (29) “Physical restraint” means the use of a device or physical action to prevent, suppress, or control head, body or limb movement, that cannot be readily and easily removed by the participant knowingly and with intent. (30) “Physician” means an individual licensed to practice medicine as defined in Health Occupations Article, §14-301, Annotated Code of Maryland. (31) “Potential for more than minimal harm deficiency” means a condition existing in a center or an action or inaction by the center staff that has the potential to cause actual harm to the participant. (32) “Pre-licensure site visit” means an on-site survey to determine if a center is ready to begin operating in accordance with the requirements set forth in this chapter. (33) “Problem list” means issues and concerns identified from the assessment. (34) “Program assistant” means an individual assigned to perform activities, supportive functions, and direct participant care under appropriate supervision. (35) “Registered nurse (RN)” means an individual licensed to practice as a registered nurse as defined in Health Occupations Article, §8-301, Annotated Code of Maryland. (36) “Secretary” means the Secretary of Health or the Secretary's designee. (37) “Self-administer” means the act of a participant taking medication at the correct time, by the correct route, and in the correct dosage, as prescribed by an authorized prescriber. (38) “Serious and immediate threat” means a situation in which immediate corrective action is necessary because a center's noncompliance with one or more State regulations has caused, or is likely to cause, serious injury, harm, impairment to, or death of a participant receiving care in the center. (39) “Significant change of condition” means a change in the participant’s physical, mental, or psychological status as defined by the registered nurses comprehensive assessment. (40) “Sustained compliance” means a period of 30 days following the date of notice of corrective action with no deficiencies. (41) “Volunteer” means an individual who: (a) Gives help, does a service, or takes an obligation, on-site for 8 hours or more per week, without payment; and (b) Serves or acts of his or her own free will under the direction of the administrative staff of the center. (42) “Written agreement” means a legally binding contract between two or more parties that sets forth terms and conditions and which has been reduced to writing and signed and dated by all parties. #### Regulation .03 License Required. *COMAR 10.12.04.03* A. A person may not establish, operate, or continue the operation of a center without first obtaining a license from the Secretary. B. Separate License Required. Separate licenses are required for centers that are maintained on separate premises, even though the centers are operated under the same management. C. Posting of License. A center shall post its license in a conspicuous place on the premises to which it applies. #### Regulation .04 Licensing Procedure. *COMAR 10.12.04.04* A. Letter of Interest. (1) A person desiring to obtain initial licensure for an adult day care center shall submit a letter of interest to the Office of Health Care Quality that contains the following: (a) Policies and procedures that address medical record completion and retention, the administration and storage of medications, nutrition services, social work support, employee criminal background checks, transportation of participants and participant activities; (b) Identification of the individual or individuals or business entity that will own and operate the adult medical day care program; (c) The job description and qualifications for each position; (d) The projected hours of operation, daily census, and the staffing plan that addresses both licensed and non-licensed staff coverage; and (e) Verification that the structural design plans for the proposed adult medical day care program have been forwarded to the Department’s Plans Review and Approval Unit. (2) An application for licensure may not be accepted by the Department until the information submitted in the letter of interest is reviewed and approved. (3) A letter of interest is not required for licensees seeking renewal. (4) Upon approval of the letter of interest, an application for licensure shall be submitted on the form developed by the Department. B. Investigation of Application. The Department's authorized representative shall interview the prospective licensee and inspect the proposed center. C. Issuance of License. When the Department determines that the center has submitted a complete application, and that the center is in compliance with this chapter, the Department shall issue a license to operate the center. D. Conditions and Limitations of License. The following conditions and limitations apply to a center's license: (1) A license shall be issued for a 2-year period, (2) The Department may perform a periodic re-inspection of the center at any time; (3) A license may not be transferable or assignable from place to place or from one person to another; (4) The licensee shall notify the Department of any change of ownership, and the new owner shall apply to the Department for a license; and (5) The number of participants cared for at any one time in a center may not exceed the licensed capacity of the center. E. Return of License. The current license shall become void immediately and the licensee shall return the license to the Secretary if the center: (1) Is sold or leased; (2) Ceases to operate for more than 30 consecutive days; (3) Moves to a new permanent location; (4) Has its license denied, suspended or revoked; or (5) Changes its Ownership #### Regulation .05 Changes in a Program that Affect the Operating License. *COMAR 10.12.04.05* A. Increase in Capacity or Name Change. (1) During the license period, a licensee may not increase capacity, change its name, or change the name under which the program is doing business without the Department's approval. When there is a change of program ownership or a change of location, the licensee shall submit a new application and written request for a new license with an application fee, as established in Regulation .04A(2) of this chapter to the Department. (2) Sale, Transfer, or Lease of a Center. (a) If a sale, lease or any other transaction causes a change in the individual or individuals who control or operate the center, the center shall be considered a new program and the new owner-operator shall apply for a new license and conform to all regulations applicable at the time of transfer of operations. (b) The transfer of any stock which results in a change of the individual or individuals who control the program or the transfer of any stock in excess of 25 percent of the outstanding stock constitutes a sale. (c) For the purposes of Life Safety Code enforcement, the program is considered an existing center if it has been in continuous use as an adult medical day program. (3) The Department shall issue a new license on approval of: (a) A change in licensure capacity; (b) A change in the name of the licensee; or (c) A change in the name under which the program is doing business. (4) The licensee shall return its original license to the Department by certified mail. B. Voluntary Closure or Change of an Adult Medical Day Program Ownership or Location. (1) A licensee shall notify the Department in writing at least 45 days in advance of any intention to: (a) Voluntarily close; (b) Change ownership; (c) Change location; or (d) Sell its adult medical day program. (2) The licensee shall include the following information in the notice to the Department: (a) The method for informing participants and participant representatives of its intent to close, change ownership, change location, or sell its center; and (b) The actions the licensee will take to assist participants in securing comparable day services and assistance, if necessary. (3) A licensee shall notify participants and participant representatives of any proposed changes set forth in §B(1) of this regulation, in writing, at least 45 days before the effective date of the proposed change. (4) Whenever ownership of a center is changed from the individual or organization named on the license to another individual or organization, the future owner shall apply for a new license. The future owner shall file an application for a license at least 45 days before the final transfer. (5) The Department shall issue a new license to a new owner if the new owner meets the requirements for licensure under this chapter. The current licensee shall return its license to the Department by certified mail. (6) A licensee named in the original license shall remain responsible for the operation of the center until a new license is issued to the new owner and the current licensee shall remain responsible for correction of all outstanding deficiencies or impending sanctions until a new license is issued to the new owner. (7) If a licensee intends to relocate its program, the licensee shall apply for a new license in time to assure continuity of services to the participants. The Secretary shall issue a new license for the new location if the program meets the requirements for licensure under this chapter. The licensee shall return its original license to the Department by certified mail. (8) After a program closes, in addition to the notice to the Department required by §B of this regulation, the licensee shall: (a) Notify the Department of the date of closure and the place of relocation of each participant; and (b) Return all licenses, past and present, to the Department by certified mail. C. Changes to Licensure Information. (1) A licensee shall immediately notify the Department of any changes that occur in the licensee's operations that were not submitted with the most recent application. (2) A licensee shall forward to the Department a copy of any report or citation of a violation that affects the health, safety, or welfare of participants, including building codes, sanitary codes, fire safety codes, or other regulations, that remains uncorrected or unresolved within 7 days of receiving the report or citation. D. License — Sale, Assignment, or Other Transfer. (1) A license is valid only in the name of the person to whom it is issued and is not subject to sale, assignment, or other transfer. (2) A license is valid only for the premises for which it was originally issued. #### Regulation .06 Waiver of Provisions. *COMAR 10.12.04.06* A. The Secretary may waive any provision of this chapter if a center: (1) Experiences practical difficulties or unnecessary hardship in complying with the provisions of this chapter: and (2) Can demonstrate that granting a waiver will not adversely affect the health and safety of its participants. B. The licensee shall submit a written request to the Department to obtain a waiver. In the written request, the licensee shall address the following issues: (1) The regulation from which a waiver is sought; (2) The reason the licensee is unable to comply with the regulation; (3) The reason that compliance with the regulation will impose a substantial hardship; and (4) The reason that a waiver will not adversely affect participants care or services. C. The Department shall provide written approval of any waiver granted to a center, and the approval letter shall specify the effective time frame for the waiver. D. The Department shall review each waiver during the license renewal process. E. The Secretary may revoke a waiver at any time if: (1) A center violates any condition of the waiver; or (2) It appears to the Secretary that the health or safety of participants attending the center will be adversely affected by the continuation of the waiver. F. The revocation of a waiver may not be appealed. #### Regulation .07 Inspection by the Department. *COMAR 10.12.04.07* A. Center Open for Inspection. (1) A licensed center and any premises proposed to be operated as a center shall be open at all reasonable times to announced or unannounced inspections by the Department and by any agency designated by the Department. (2) Any part of the center, and any surrounding accessory buildings, are considered part of the center and are subject to inspection. B. Records and Reports. (1) A licensee shall maintain records and make reports as required by the Department. (2) The records and reports shall be open to inspection by the Department or any agency designated by the Department. (3) On request, a licensee shall immediately provide copies of records and reports, policies and procedures, including medical records of current participants, participants discharged within the last 6 months, personnel records of current staff, and those records and reports relating to quality assurance activities to the Department or any agency designated by the Department. (4) All other records and reports may be stored off-site, but shall be available to the Department within 24 hours of request. (5) If requested, the Department shall reimburse the licensee for the reasonable costs of copying the records and reports. #### Regulation .08 Compliance Monitoring. *COMAR 10.12.04.08* A. The Department shall monitor or inspect a center at least once every 2 years to ensure compliance with the requirements of this chapter. B. The Department may conduct unannounced or announced licensure or complaint investigation visits as frequently as necessary to ensure compliance with this chapter or for the purpose of investigating a complaint. C. In accordance with a written agreement, the Department may delegate certain aspects of its monitoring or inspection responsibilities to a local health department. D. Notice of Violations. If a complaint investigation or survey inspection identifies a regulatory violation, the Department shall issue a notice: (1) Citing the violation; (2) Requiring the center to submit an acceptable plan of correction within 10 calendar days of receipt of the notice of violation or deficiency; (3) Notifying the center of sanctions or that failure to correct the violation may result in sanctions; and (4) Offering the center the opportunity for informal dispute resolution (IDR). E. The plan of correction referred to in §D(2) of this regulation shall include the date by which the licensee shall complete the correction of each deficiency. Failure to return an acceptable plan of correction within the allotted time frame may result in a sanction. F. When a licensee requests an IDR as provided in §G of this regulation, the licensee shall file a plan of correction within the required time, except to the extent that the licensee contests specific findings, in which case absent the Department's specific directive, a licensee may delay submitting its plan of correction with respect to those specific findings until 5 days after the licensee is provided oral or written notice of the outcome of the IDR. G. Informal Dispute Resolution. (1) A licensee may request an IDR to question violations or deficiencies within 10 calendar days of receiving the statement of deficiencies. The written request for an IDR shall fully describe the disagreement with the statement of deficiencies and be accompanied by any supporting documentation. (2) At the discretion of the Office of Health Care Quality, the IDR may be held in-person, by telephone, or in writing. In-person IDRs are informal in nature and are not attended by counsel. (3) The IDR process may not delay the effective date of any enforcement action. (4) In the event a licensee requests an IDR of a violation written by a designee of the Department, the Department shall request the designee to participate in the IDR process. #### Regulation .09 Administration. *COMAR 10.12.04.09* A. Governing Body. The governing body shall establish and maintain sound operating procedures, including: (1) Maintenance of an identifiable administrative unit, headed by a director who is responsible for the overall conduct of all center activities; (2) Adoption of an annual budget; and (3) Provision of staff capable of performing the center's program. B. Goals. The center shall have documentation of its philosophy and goals and the services to be provided. The services to be provided by the center shall be reflective of the populations served. C. Policies and Procedures. The governing body shall establish policies and procedures for the center, including: (1) Admissions; (2) Discharges; (3) Fees; (4) Health care; (5) Hours of operation; (6) Personnel; (7) Plans for emergencies, disasters, and epidemics; (8) Use of consultants; (9) Relationships with other agencies and care providers; (10) Documentation and accounting procedures for medications released into the community; (11) Quality assurance; and (12) Other policies as necessary D. The center shall provide OHCQ a contact phone number, providing direct access to the center or center’s representative that shall be available 24 hours a day, 7 days a week. E. The governing body shall review all policies annually and make revisions as necessary. A Registered Nurse shall assist in the review process and in developing health policies and providing other services as indicated. #### Regulation .10 Days and Hours of Operation. *COMAR 10.12.04.10* A. The center shall be open to participants for at least 6 hours per day 5 days a week, exclusive of holidays and other planned closings. B. The center's hours of operation shall be posted in a prominent place accessible to and easily seen by participants. C. The public and participants shall be notified of planned closings. #### Regulation .11 Preadmission Assessment. *COMAR 10.12.04.11* A. Before admission, the center shall obtain a written assessment from the prospective participant's health care provider, who shall certify that the information provided reflects the individual's health status within 45 days of the individual's admission. Upon request and for good cause shown, the Department may grant an exception to all or part of the preadmission assessment. B. Written Assessment. The health care provider's assessment shall include: (1) Recent medical history, including any acute medical condition or hospitalization; (2) Significant medical conditions affecting function, including the individual's ability for self-care, cognition, physical conditions, and behavioral and psychosocial status; (3) Other active and significant chronic or acute medical diagnoses; (4) Known allergies to medications, environment, and food; (5) Medical confirmation that the individual is free from communicable disease and other active reportable airborne diseases; (6) Current and other needed medications and treatments and the ability of the individual to self-medicate or self-treat; (7) Information of advanced directives for health care; (8) Current nutritional status including height, weight, risk factors, and deficits; (9) Diets ordered by the health care provider; (10) Medically necessary limitations or precautions; and (11) Monitoring or performance of tests after admission. #### Regulation .12 Admission Criteria. *COMAR 10.12.04.12* A. The center shall develop written criteria for admission. These criteria shall be specific so that the center does not accept individuals whose needs cannot be met by the center. B. Admission Criteria. The admission criteria shall include at least the following: (1) The center may not discriminate against the intended participant because of race, color, or national origin according to Title VI of the Civil Rights Act of 1964, 42 U.S.C. §2000 or as otherwise provided by law; (2) The center may not deny admission to or involuntarily discharge an individual solely because the individual has a communicable disease. C. The center shall provide the participant and his or her responsible party a written service contract. D. The service contract shall be signed by both the center’s representative and the participant or his or her responsible party. E. The service contract shall specify: (1) Number of days per week and type of services that are to be provided to the participant; (2) Process by which goals are developed for the participant; (3) Conditions under which the participant may be discharged; and (4) Consent agreements as required for: (a) Transportation; (b) Treatment; (c) Medication administration; (d) Off-site activities; (e) Photographs for promotional use; and (f) Release of medical information. #### Regulation .13 Participant Rights. *COMAR 10.12.04.13* A. The adult day care center shall provide care for participants in a manner and in an environment that maintains or enhances each participant’s dignity and respect. B. The center shall inform the participant, in a language that the participant understands, of his or her rights and all rules and regulations governing participant conduct and responsibilities while attending the program. C. A participant of a center has the right to: (1) Be treated with consideration, respect, and full recognition of the participant's human dignity and individuality; (2) Receive treatment, care, and services that are adequate, appropriate, and in compliance with relevant State, local, and federal laws and regulations; (3) Privacy; (4) Be free from mental, verbal, sexual, and physical abuse and neglect, involuntary seclusion, and exploitation; (5) Be free from physical and chemical restraints except as permitted in Regulation .23 of this chapter; (6) Confidentiality; (7) Make suggestions, complaints, or present grievances on behalf of the participants or others, to the center director, government agencies, or other individuals without threat or fear of retaliation; (8) Receive a prompt response, through an established complaint or grievance procedure, to any complaints, suggestions, or grievances the participant may have; (9) Have access to the procedures for making complaints to the: (a) Local department of social services; and (b) Office of Health Care Quality of the Department; (10) Participate in care planning and medical treatment; and (11) Refuse treatment after the possible consequences of refusing treatment is fully explained. #### Regulation .14 Staff. *COMAR 10.12.04.14* A. Staffing Pattern. (1) Staffing Ratio. (a) The staff to participant ratio at each center shall be a minimum of one staff to seven participants (1:7) for a period of 2 years after the final adoption of COMAR 10.12.04.14A(1)(a). (b) Two years after the final adoption of COMAR 10.12.04.14A(1)(a), the staffing ratio at each center shall be determined by the needs of each program participant as determined in the ADCAPS. (c) Staffing shall at all times be sufficient to meet the needs of the participants. (2) The center shall have experienced and competent relief personnel, with licenses and levels of skill comparable to regular staff, to operate during absences, vacations, or other periods necessitating substitute staff. (3) Relief personnel shall be oriented to the operation of the center. B. Required Staff. (1) Director. (a) The center shall have a director who is responsible for the overall conduct of the center and for compliance with applicable laws and regulations. (b) The director shall have a bachelor's degree, preferably in a health and human services field, from an accredited college or university, or the individual shall be a registered nurse. (c) The director's duties shall be limited to the administration and provision of services at the center. (d) If a center is part of another center, the center shall have its own director and center staff. (e) A center with a licensed capacity of 35 or more participants shall have a full-time director. (f) A center with a licensed capacity of 34 or fewer participants may appoint a director who serves on less than a full-time basis. (g) A licensee operating two adult medical day care sites that are located within 50 miles of each other may utilize one on-site manager instead of a director at one of the sites if there are fewer than 50 participants at each site. The on-site manager shall have the appropriate background, education, and experience to oversee the administration and provision of services at the center. (2) Nursing Services. (a) A center shall have the services of a registered nurse with at least 3 years experience in a health care setting. (b) A registered nurse shall be on-site or readily available by phone at other times to satisfy the requirements listed in §B(2)(c) of this regulation. (c) The duties of the registered nurse shall include: (i) Completion of the ADCAPS and the nursing plan of care. (ii) Provision or supervision, or both, of required nursing services to each participant; (iii) Supervision of the LPN and other nursing care staff in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11.05H(1); (iv) Development and ongoing review of the participant's plan of care; and (v) Assisting, as necessary, in the delivery of other required services. (d) A licensed practical nurse performs in a team relationship with the registered nurse and shall be on site to meet the nursing services of each participant consistent with COMAR 10.27.10 when the registered nurse is not on site. (e) A certified nursing assistant shall be present and on site when a registered nurse or licensed practical nurse is not on site. (3) Full-time Activities Coordinator. The center shall have the services of a full-time activities coordinator who shall have: (a) A high school diploma or general equivalency diploma (GED); and (b) At least 3 years experience in activities coordination or therapeutic recreation for: (i) The aged; (ii) Individuals with disabilities; or (iii) Other special populations. (4) Staff. (a) Program assistants shall: (i) Have a high school diploma or general equivalency diploma (GED); or (ii) Be enrolled currently in a program leading to a high school diploma or GED. (b) The center shall employ sufficient staff to meet the participants' needs. C. Personnel Policies. (1) The center shall have written personnel policies, including at least the following: (a) Annual leave; (b) Pay practices; (c) Employee benefits; (d) Termination procedures; (e) Hiring and firing responsibility; (f) Review of applicant and employee criminal conviction histories; (g) New employee orientation; and (h) Use and duration of a probationary period. (2) The center shall make a copy of its policies and procedures available to each employee. (3) Before hiring, staff: (a) Shall have a criminal background check as required in Health-General Article, §19-1901, et seq., Annotated Code of Maryland; and (b) May not have criminal convictions or criminal history that indicates behavior that is potentially harmful to participants, as evidenced through a criminal history records check. D. Position Description. There shall be a written position description for each job that specifies: (1) The qualifications for the job; (2) A delineation of the tasks; and (3) The supervisor of the employee. E. Staff Training. (1) When job duties involve the provision of individual care services, employees shall receive a minimum of 2 hours of training on cognitive impairment and mental illness within the first 90 days of employment, including the following as appropriate: (a) Overview of normal aging and conditions causing cognitive impairment; (i) Risk factors for cognitive impairment; (ii) Health conditions that affect cognitive impairment; and (iii) Early identification of and intervention for cognitive impairment; (b) Overview of normal aging and conditions causing mental illness; (i) Risk factors for mental illness; (ii) Health conditions that affect mental illness; (iii) Early identification of and intervention for mental illness; and (iv) Procedures for reporting cognitive, behavioral, and mood changes; (c) Effective communication including: (i) The effect of cognitive impairment on expressive and receptive communication; (ii) The effect of mental illness on expressive and receptive communication; (iii) Effective verbal, nonverbal, tone and volume of voice, and word choice techniques; and (iv) Environmental stimuli and influences on communication; and (d) Behavioral intervention, including: (i) Identifying and interpreting behavioral symptoms; (ii) Problem solving for appropriate intervention; (iii) Risk factors and safety precautions to protect the individual and other participants; and (iv) De-escalation techniques. (2) The director shall ensure that: (a) Per the center’s policies, staff and volunteers receive orientation and training; and (b) An ongoing educational program is planned and conducted for the development and improvement of skills of all the center's personnel, including training related to problems and needs of the elderly, health impaired, and disabled. (3) The center shall maintain records that demonstrate proof of employee attendance and training content of orientation and in-service programs. (4) The center shall provide a minimum of eight in-service training sessions annually, which shall include, but is not limited to: (a) Prevention and control of infections; (b) Fire prevention programs and participant-related safety procedures in emergency situations or conditions; (c) Accident prevention; (d) Training on care of individuals that is appropriate to the population served by the center, such as: (i) Alzheimer's disease; (ii) Mental illness; (iii) Developmental disabilities; and (iv) Cognitive impairment; (e) Recognition of, and duty to report, abuse, exploitation, neglect, and self-neglect; and (f) Safe food handling and service. (5) The training that is described in §F of this regulation may be provided through various means including: (a) Classroom instruction; (b) In-service training; (c) Internet courses; (d) Correspondence courses; (e) Prerecorded training; or (f) Other training methods. F. When the training method does not involve direct interaction between faculty and trainee, the center shall make available to the trainee a trained individual to answer questions and respond to issues raised by the training. G. Proof of training shall include: (1) Date of class; (2) Course content; (3) Documentation of successful completion of the training content; and (4) Qualifications and contact information for the trainer. #### Regulation .15 Program Components — Required Services. *COMAR 10.12.04.15* A. Health Services. (1) Nursing Services. The center shall provide nursing services under the direction of a registered nurse. The licensee shall fully disclose the services that will be provided outside the adult medical day care center’s hours of operation, in the service contract agreement. The registered nurse may delegate nursing services as appropriate, to other staff in accordance with COMAR 10.27.09, 10.27.10, and 10.27.11.05H(1)—(3). (2) Consultation with the Health Care Provider. The RN or LPN nurse shall communicate with the participant's health care provider to report observed changes in the participant's health status, including reaction to medicine, and to obtain current medical orders regarding such items as diet, medications, and treatments. The center shall assist participants in locating a regular source of health care if a participant does not have a health care provider. (3) Mental Health Services. For participants with mental health needs, the program shall provide, when needed, linkage, collaboration, and coordination with the participant's treating psychiatrist or other mental health professional. (4) Observation. The registered nurse or the licensed practical nurse shall observe the health, functional status, and adherence to a prescribed medical regimen, and document his or her observations in the participant's medical record at least monthly. (5) The center shall provide meals and snacks to participants in accordance with Regulation .20 of this chapter. B. Emergency Services and Medical Plan. (1) The center shall have a written emergency medical plan for linkage and access to: (a) Emergency medical care including a health care provider on call in the event that a participant's primary care provider is unavailable; (b) Hospitalization and emergency room care; and (c) Transportation to the center providing the emergency care. (2) The center shall have an established procedure to be followed in an emergency that covers: (a) Immediate care of the participants; (b) Individuals to be notified; and (c) Reports to be prepared. C. Activities Programs. (1) Activities Plan. (a) There shall be a written planned program of daily activities that are age appropriate and culturally relevant for individuals served and designed to: (i) Meet the participant's specific needs, preferences, and interests with the individual's cognitive and physical limitations being noted in the development of the activities; and (ii) Stimulate interests, rekindle motivation, and provide opportunities for a variety of types and levels of involvement, including small and large group activities. (b) Staff shall also plan a weekly or monthly calendar of activities that shall be posted in an area of the center where it is plainly visible and easily read by all participants. (2) Each day's activities shall include: (a) Physical exercise; (b) Rest; (c) Social interaction; (d) Personal care, if needed; and (e) Mental stimulation. (3) The center shall permit participants to choose between group and individual activities during some part of the day. (4) Participants shall have the choice of refusing to participate in any activity. D. Activities of Daily Living (ADL). Staff shall provide the assistance needed by participants to complete activities of daily living. #### Regulation .16 Program Components. *COMAR 10.12.04.16* A. Special Services. (1) The center shall provide or make arrangements for the services listed in §A(2)—(8) of this regulation when the center admits participants that require these services. (2) Diet Modifications. The center shall provide special diets and other diet modifications as ordered by the participant’s health care provider. (3) Rehabilitative Services. Rehabilitative services may include: (a) Physical therapy; (b) Occupational therapy; and (c) Speech pathology provided directly, or indirectly, through arrangements with qualified personnel. (4) Social Services. A licensed social worker shall provide social work services to participants. If social and emotional needs are identified during the assessment that is required in Regulation .10 of this chapter, a licensed social worker shall be consulted before the establishment of goals to meet those needs. (5) Mental Health Services. When mental health needs are identified, the program shall seek consultation from a mental health professional authorized under the Health Occupations Article, Annotated Code of Maryland. (6) Services for the Developmentally Disabled. For individuals provided residential services through the Developmental Disabilities Administration, the center shall incorporate the individual plan (IP) in the development of the individual's plan of care and the activities plan. (7) Medical Consultation. The center may use specialists on a part-time or consultant basis in: (a) Psychiatry; (b) Physiatrics; (c) Orthopedics; or (d) Other specialties according to the needs of the participants. (8) Other Special Services. The center may provide the following services as needed: (a) Alcoholism counseling; (b) Podiatry; (c) Dentistry; (d) Nutrition counseling; (e) Health education; and (f) Other services depending upon need. B. Consultants. (1) Except as otherwise provided, when regular employment status, full-time or part-time, is not justified by the needs of the participants, the center may use consultants to meet the service and training needs of the center. (2) When the center uses the services of a consultant, these services shall be specified in a written agreement that is signed and dated by the consultant and the center director. #### Regulation .17 Medication Services and Policies. *COMAR 10.12.04.17* A. Written policies for the center shall specify that the RN, LPN, or CMT is authorized to procure, receive, control, and manage the administration of medications at the center. B. Medications. (1) Medicine or drugs shall be restricted to those prescribed for the participant by the authorized prescriber. (2) All medications shall be accurately and plainly labeled and kept in the original container issued by the prescriber or pharmacist except as provided in §F(3) of this regulation. (3) Containers shall be labeled with the: (a) Participant's full name; (b) Authorized prescriber; (c) Prescription number; (d) Name of the medication and dosage; (e) Date of issuance; (f) Expiration date; (g) Refill limits; (h) Directions for use; and (i) Name, address, and telephone number of the pharmacy issuing the drug. C. Nurses may not package, repackage, bottle, or label, in whole or in part, any medication in any way by tampering or defacing any labeled medication, except that a nurse may take medications from pharmacy dispensed containers and place the medication in a pill box for the cognitively intact participant who lives independently to self-administer. D. When a RN or LPN observes an adverse reaction to a medication, the nurse shall immediately call the: (1) Participant's health care provider; (2) Designee of the participant's health care provider; or (3) The health care provider that is on call for the center. E. Drug Administration and Recording. (1) The center shall maintain records of all Schedule II drugs. (2) Written Order. (a) Except as provided in §E(2)(b) of this regulation, medications may not be administered without a written order that has been signed by the authorized health care provider. (b) Medication may only be given based upon a verbal order when the verbal order has been recorded and signed by the RN or the LPN. (c) Verbal orders shall be signed by the authorized health care provider within 30 days. (3) Except as provided in Regulation .14B(2)(c)(iii), only an RN, LPN, or authorized health care provider shall give injectable medication. (4) For those participants who are not capable of self-medicating, the individual assigned the responsibility of administering medications shall: (a) Prepare the dosage; (b) Observe the participant swallowing the oral medication; and (c) Document that the participant has taken the medication. (5) Staff members who are licensed and certified to administer medications shall make a written record of the medications and treatments that are administered. (6) Orders shall be reviewed and updated in a timely manner, consistent with nursing practice standards, when there is a change in the participant's condition. F. Drug Storage. (1) The center shall: (a) Provide a safe, secure, locked place for medicines or drugs, and for making medications available to a participant according to the instructions of his or her health care provider; (b) Store Schedule II drugs in a locked box within the medicine cabinet; (c) Keep medications requiring refrigeration in a separate locked refrigerator or a locked box within a medication refrigerator; and (d) Store medications and medical supplies in a manner that is secured and apart from participant activity areas, food storage areas, and chemical storage areas. (2) A licensed nurse shall inspect the drug storage conditions at least every 3 months and document his or her findings. (3) The center may keep over-the-counter type medications or supplements that can be purchased without prescription, such as aspirin or antacids, for administration as ordered by the participant's practitioner. #### Regulation .18 Orders. *COMAR 10.12.04.18* A. Orders concerning medication, treatment, and diet shall be in effect for the specified number of days indicated by the health care provider. If not specified, the period may not exceed 6 months. B. Verbal Orders. (1) A licensed nurse shall take verbal medication orders from a health care provider. (2) The nurse shall immediately write orders into the participant's record, and sign and date the note. (3) The original or faxed medication order shall be included in the medical record within 10 calendar days after the date of the telephone order. #### Regulation .19 First-Aid and Cardiopulmonary Resuscitation. *COMAR 10.12.04.19* A. At least one staff member who is trained in first aid and in cardiopulmonary resuscitation (CPR) shall be on-site at the center when participants are in attendance, during outings, medical appointments or during transportation of participants. B. At least one staff member who is trained in CPR and first aid shall accompany participants taken outside of the center for outings and other activities. C. First aid administered by staff shall be limited to that necessary to preserve life or to prevent further immediate danger. D. Staff shall receive first aid and CPR training from a certified provider approved by the Department. Recertification shall be obtained according to the guidelines of the certified provider. E. The center shall have adequate first aid supplies available for treating shock, burns, and small, medium, and large wounds. F. On a 90-day basis, staff shall inspect first aid supplies in the center and in the vehicle or vehicles used for transporting participants. Expiration dates of supplies and the maintenance of supplies at the required levels shall be included in the inspection. The findings of the inspection shall be documented at least quarterly. G. Supplies with an expired date shall be replaced immediately. H. The center shall conspicuously post a chart clearly describing first aid and emergency medical treatment techniques and the names and phone numbers of health care providers, ambulances, and medical facilities. #### Regulation .20 Nutrition. *COMAR 10.12.04.20* A. The center shall ensure that each participant who is present for 4 or more hours is provided with a meal that meets 1/3 of the recommended dietary allowance of the Food and Nutrition Board of the National Research Council. B. The center shall provide snacks consisting of a nourishing food or beverage, or both, to participants. C. The minimum number of meals and snacks shall be provided as follows: D. A center may prepare food on-site if the center meets the requirements of COMAR 10.15.03. E. The center shall ensure that food prepared off-site from the center is prepared in a center which meets the requirements of COMAR 10.15.03. F. Therapeutic diets approved by a registered and licensed dietitian shall be served only as ordered. G. Staff shall assist participants who may be unable to feed themselves, in accordance with the ADCAPS. H. A Registered Dietitian shall perform a nutritional assessment for all participants with a potential, or an actual, nutritional deficit. #### Regulation .21 Comprehensive Assessments. *COMAR 10.12.04.21* A. The participant shall receive a comprehensive assessment (ADCAPS) that is designed to evaluate the participant's strengths and needs. A registered nurse shall complete the initial assessment within 30 days of a participant's admission and every 120 days thereafter as long as there is no change in the participant's condition. The assessment shall include: (1) Health status; (2) Functional status; (3) Participation in activities; (4) Nutritional status; (5) Psychosocial status; and (6) Home management skills. B. Regardless of the schedule in §A of this regulation, the licensed or certified professional health care provider shall complete a reassessment by the end of the participant's next day of attendance when any significant change in the participant's condition occurs. The practitioner shall perform a follow-up evaluation of any significant change, and document the evaluation in the participant's medical record. #### Regulation .22 Care Planning. *COMAR 10.12.04.22* A. Individualized Plan of Care. (1) There shall be an individualized plan of care completed for each participant within 30 days following admission. (2) The participant shall participate in the development of the plan of care, along with the multidisciplinary team, unless the center documents the reasons why the participant is unable or unwilling to participate. (3) The plan of care shall be consistent with the comprehensive assessment and shall include a problem list. (4) A registered nurse shall update the plan of care within 7 calendar days of a participant's change in status, but not less than semiannually. (5) The participant's plan of care shall be based on the comprehensive assessment that is completed by registered nurse as described in Regulation .21 of this chapter. (6) The plan of care shall include: (a) Orders by a Health care provider; (b) All pertinent diagnoses; (c) Frequency and types of services required; (d) Treatment goals for each type of service ordered; (e) Rehabilitation, services, and prognosis; (f) Functional and cognitive limitations; (g) Level of activity permitted; (h) Diet; (i) Medication and treatment or treatments; (j) Measurable goals for each problem or need that is identified; (k) Goals that are realistic, practical, and tailored to the desired outcome for the participant; and (l) Approaches to accomplishing each goal. (7) The multidisciplinary team shall document all components of the participant's care plan in the participant's medical record; (8) The center shall give family members, and others designated by the individual with proper consent or responsible parties, an opportunity to participate in the care plan meeting. B. Attendance and Unscheduled Absences. (1) Staff shall maintain daily records on each participant's attended days of care. (2) When a participant is absent on a scheduled day, staff shall investigate on the day of the occurrence to learn the reason for the absence and document the reason. (3) The center shall have documentation that: (a) Absences are reviewed on at least a 30-day basis; and (b) Appropriate action has been taken. #### Regulation .23 Use of Restraints. *COMAR 10.12.04.23* A. Policy and Procedures. The center shall have a policy and procedure on the use of any device or medication for the specific purpose of restricting the participant's freedom of motion or movement within the center. B. A participant has the right to be free of restraints used in violation of this chapter C. Improper Use of Chemicals or Drugs. Chemicals or drugs may not be used for participants in the following ways: (1) In excessive dose, including duplicate drug therapy; (2) For excessive duration, without adequate monitoring; (3) Without adequate indications for its use; or (4) In the presence of adverse consequences which indicate the dose should be reduced or discontinued. D. Improper Use of Physical Restraints. Participants may not be physically restrained: (1) For discipline or convenience; or (2) If a restraint is not ordered by a physician to treat the participant's symptoms or medical conditions. E. Restraint Orders. (1) All restraints shall be ordered by a physician and shall specify: (a) The purpose of the restraint; (b) The type of restraint to be used; and (c) The length of time the restraint shall be used. (2) A participant may not have an as-needed restraint order. (3) Orders for the use of a restraint shall be time specific. (4) A participant may not remain in a restraint for more than 2 hours without a change in position and toileting opportunity. (5) If an order for the use of a restraint is to be continued, the order shall be renewed at least every 7 days by a physician. (6) The health care provider shall provide training to staff in the appropriate use of the restraint ordered by the physician. F. The program shall notify the participant's family or the participant's representative each time a restraint is used. #### Regulation .24 Discharge. *COMAR 10.12.04.24* A. Before a center discharges a participant, the center shall: (1) Formulate a discharge plan, including at least a 30-day written advance notice to the participant or the participant's responsible party; and (2) Assist the participant in obtaining the resources needed to implement the plan. B. The 30-day written notice of discharge specified in §A of this regulation is not required when: (1) The health or safety of the participant or other individuals in the center would be endangered by the continued presence of the participant; (2) The participant has urgent medical needs; or (3) There is an emergency requiring less than 30 days notice. C. In circumstances described in §B(1), (2) or (3) of this regulation, the center shall provide written notice of discharge as soon as practicable before discharge. D. The center shall document in the participant's discharge summary the reasons for discharge and the center or location to which the participant was discharged. #### Regulation .25 Reports and Actions Required in Unusual Occurrences. *COMAR 10.12.04.25* A. The center shall immediately report an occurrence such as a communicable disease or food-borne outbreak, poisoning, death, fire, use of restraints or other unusual incident that threatens the health or safety of any participant or staff member to: (1) The Office of Health Care Quality; (2) The local health officer, as required by law; (3) Participant; and (4) Family and, if applicable, guardian. B. The center shall document the incident in the participant's medical record or the staff member's personnel file, if applicable. C. Staff shall report cases of abuse, neglect, self-neglect, or exploitation of participants to the: (1) Local police; (2) Department; and (3) Local department of social services. D. If a participant becomes a danger to self or others the center shall, as appropriate, contact the local emergency system or immediately notify the participant's licensed or certified professional health care provider and the participant's family or caregiver. #### Regulation .26 Records. *COMAR 10.12.04.26* A. Records. The center shall maintain records that are needed to operate the center, as required by the Department, and to document the progress of the participants. B. Retention. The center shall maintain participants' records for at least 5 years from the date of discharge, except as provided in Health-General Article, §4-403, Annotated Code of Maryland. C. Confidentiality. The center shall maintain records so that they are accessible only to the director, the staff, emergency personnel, and to funding and monitoring agencies. The center may not discuss or reveal the contents of the records with any persons other than those listed above without the participant's written permission. D. Required Records. (1) Participant Records. The center shall maintain at least the following information for each participant: (a) Name, age, sex, address, and telephone number; (b) Name and telephone number of the individual to be notified in case of emergency; (c) Next of kin; (d) Medicare, Medicaid, or private insurance member enrollment numbers related to health care benefits; (e) Name and address of primary care provider, with changes noted and dated when change occurs; (f) Functional assessment with original and revised versions noting participant progress; (g) Assessment of the home environment at the time of intake and as needed, or at change of home address; (h) Individual plan of care; (i) Admission physical and subsequent additional information; (j) Medications and adverse drug reactions; and (k) Accidents. (2) Personnel Records. The center shall maintain the following information for each staff member: (a) Name, age, sex, address, and telephone number; (b) Educational background; (c) Employment history and notes on references; (d) Performance evaluations and attendance; (e) Individual to be notified in case of emergency; (f) Documentation that the individual is free from tuberculosis, measles, mumps, rubella, and varicella as evidenced by: (i) Physician’s statement; (ii) Positive disease histories affirmed by employee’s signature; (iii) Antibody serology’s of titer; (iv) Skin tests; or (v) Statement of vaccinations, affirmed by the employee signature; (g) Evidence that the annual influenza vaccine has been advised; (h) Any impairment which would hinder the performance of assigned responsibilities; and (i) Documentation of a criminal history records check in accordance with Health-General Article, §19-1901, Annotated Code of Maryland; (j) The official driving record and a copy of a valid driver's license if driving is a condition of employment; and (k) Copies of written agreements with consultants, including services to be provided. (3) Volunteer Records. (a) The center shall urge that volunteers accept annual influenza vaccination and tuberculin testing as considered necessary by the center. (b) The center shall give appropriate health care information to such volunteers to provide maximum protection to residents. (c) The center shall maintain documentation of the discussion between the center and the volunteer concerning influenza vaccine and tuberculin testing. (4) Administrative and Fiscal Records. The center shall maintain the following administrative and fiscal records: (a) Expenditures with substantiating documentation; (b) Current and projected annual operating budgets, including specific cost allocations and formula for determining projected expenditures, and including accurate per diem costs; (c) Fee charged, and fee schedule, if appropriate; (d) Records of in-service training offered by the center; (e) Current inspection reports from the health and fire departments; (f) The daily schedule of activities; (g) Daily menu of meals and snacks served for a 30-day period; (h) Attendance records; and (i) Audit reports. #### Regulation .27 Transportation. *COMAR 10.12.04.27* A. The center shall provide or arrange transportation to enable participants to attend the center and to participate in activity outings, medical appointments, or other participant required services. B. The center and its staff shall operate vehicles in accordance with all applicable federal, State, and local requirements. C. A participant may not be in transit for more than 1 hour without an opportunity for a rest stop: (1) For a period of 2 years after the final adoption of Regulation .14A(1)(a) of this chapter; and (2) Two years after the final adoption of Regulation .14A(1)(a) of this chapter, the center shall utilize the ADCAPS to determine the length of time a participant may be in transit without a rest stop. D. A participant may not be brought to or left at the center when staff is not present. E. A participant may not be left in a vehicle when staff is not present, except when the driver is assisting participants to and from their residences and the driver is within eyesight of the vehicle. F. Centers shall promote and manage vehicle safety, driver safety, accident control and reporting, and driver corrective action efforts. G. A driver may not leave a participant at a home until the participant is met at the home or enters the home. H. If assistance is needed due to the participant’s documented mobility limitations, a driver shall assist the participant to their home. I. Driver Training. (1) The center shall provide driver training to all employees who are expected to operate motor vehicles as part of their official responsibilities. (2) The following topics shall be included in the driver training: (a) Review of State vehicle law; (b) Approaches for defensive driving; and (c) Control of aggressive driver behavior. J. The center shall assure that activities and field trips are staffed in accordance with participant needs as documented in the ADCAPS. #### Regulation .28 Physical Plant. *COMAR 10.12.04.28* A. New Center. (1) A new center shall be designed, constructed, and maintained according to applicable federal, State, and local codes and regulations for building, zoning, fire, food, safety, health and other related codes or ordinances, or both. The center shall also comply with the requirements of the Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq. (2) Where possible, the center shall be located at street level. If a proposed center will not be located at street level, the licensee shall obtain prior approval from the Department before design work proceeds. B. Existing Center. Any conversion, alteration, or addition that affects the center's functional structure or participant capacity, shall be constructed in accordance with this chapter, including the regulations that apply to new centers. C. Multi-Use Facilities. (1) When a center operates in a multi-use center such as a hospital, nursing home, assisted living program, religious structure, or a school, the center shall have a written agreement regarding the cooperative use of facilities allowing the center adequate separate space during its hours of operation. (2) Certain spaces may be shared with other groups, such as the kitchen and therapy rooms. Where spaces are to be shared, a written agreement shall govern the use of space. D. Space. (1) The center shall have sufficient space to accommodate the full range of program activities and services. The center shall be flexible and adaptable to accommodate a variety of group or individual activities and services, and to protect the privacy of participants receiving services. The Department may require more than the minimum square footage to ensure that there is space for the center to provide activities and services that meet the needs of the participants. (2) The center shall have the following minimum square footage requirements for activity space: (a) 100 square feet for each of the first five participants; and (b) 60 square feet per participant thereafter. (3) Usable Area. In determining required square footage, only those activity areas commonly used by participants are to be included. Fifty percent of the total usable square footage of kitchen areas shall qualify as activity space if participants use these areas as part of the center's activities programs. (4) Non-Usable Area. Administrative areas, reception areas, offices, closets, storage rooms, toilets and bathrooms, utility rooms, and passageways may not be included when calculating the qualifying usable square footage for activities. The actual footprint of finished space shall be what constitutes usable space. This excludes the space between partition walls, and the space between the finished interior wall and the outside of the exterior wall. (5) The center shall provide the following: (a) Private space to permit staff to work effectively and without interruption; (b) A large room or access to a large room where all participants can gather and rooms or divided areas for small group activities; (c) A designated rest or quiet area to provide visual privacy to isolate participants that become ill or disruptive or who may require rest; (d) A separate space where participants, family, caregivers, or staff may have private conversations; (e) Adequate space that is located in or adjacent to activity areas or offices for storage of activity and operating supplies. (f) Exterior lockable doors; and (g) An effective automated device or system to alert staff to participants entering or leaving the building. (6) The center need not use an automated alert for an exit door when the exit door is staffed by a receptionist or other staff member who views and maintains a log of the participants entering and leaving the center. #### Regulation .29 Emergency Preparedness. *COMAR 10.12.04.29* A. The center shall develop an emergency and disaster plan that includes policies and procedures that shall be followed before, during, and after an emergency or disaster, including: (1) The safe management of individuals who are receiving services at the adult medical day care center when an emergency occurs; (2) Notification of families, staff and licensing authorities regarding the action that will be taken concerning the safety and well-being of the participants; (3) Staff coverage, organization, and assignment of responsibilities; and (4) The continuity of operations, including procedures to secure access to essential goods, equipment, and services to sustain operation. B. A center is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the center under this regulation. C. This regulation does not prohibit an adult medical day care center from applying for and receiving reimbursement: (1) Under any applicable insurance policy; or (2) From any state or federal funds that may be available due to a declared state or federal emergency. D. For purposes of coordinating local emergency planning efforts a center shall provide access to the emergency plans developed under this regulation to local organizations for emergency management. E. The center shall provide OHCQ a contact phone number, providing direct access to the center or center’s representative that shall be available 24 hours a day, 7 days a week. F. Evacuation Plans. The center shall conspicuously post individual floor plans with designated evacuation routes on each floor. G. Orientation and Drills. (1) The licensee shall: (a) Orient staff to the emergency and disaster plan and to their individual responsibilities within 24 hours of the commencement of job duties; and (b) Document completion of the orientation in the staff member's personnel file through the signature of the employee. (2) Fire Drills. (a) The center shall conduct fire drills at least quarterly on all shifts. (b) Documentation. The center shall: (i) Document completion of each drill; and (ii) Maintain the documentation on file for a minimum of 2 years. (3) Semiannual Disaster Drill. (a) The center shall conduct a semiannual emergency and disaster drill on all shifts during which it practices evacuating participants or sheltering in-place so that each is practiced at least one time a year. (b) The drills may be conducted via a table-top exercise if the program can demonstrate that moving participants will be harmful to the participants. (c) Documentation. The center shall: (i) Document completion of each disaster drill or training session; (ii) Have all staff who participated in the drill or training sign the document; (iii) Document any opportunities for improvement as identified as a result of the drill; and (iv) Keep the documentation on file for a minimum of 2 years. (4) The licensee shall cooperate with the local emergency management agency in emergency planning, training, and drills and in the event of an actual emergency. #### Regulation .30 Furniture, Furnishings, and Supplies. *COMAR 10.12.04.30* A. Furniture. (1) The furniture in a center shall be: (a) Appropriate for use by individuals with disabilities; (b) Sturdy and secure so that it cannot easily tip when used for support while walking or seated; (c) Designed so that it is used easily by individuals with limited agility, permitting feet to rest on the floor and having armrests; and (d) Clean, safe, and in good repair. (2) The center shall have sufficient furniture for the entire participant population. Straight-backed chairs with armrests shall be available for use by participants during activities and meal times. (3) The center shall have at least: (a) One chair for each participant and each staff member; (b) Adequate table space for all participants; (c) Reclining lounge chairs, the number to be determined by the needs and numbers of participants; and (d) A bed for medical examinations and for temporary holdover for participants who become ill or upset. B. Furnishings. (1) Floor Coverings. All rugs and floor coverings shall be secured to the floor to eliminate tripping hazards. (2) All equipment and furnishings shall be in good condition and safe for use by participants and staff. C. Equipment and Supplies. (1) The center shall provide equipment to encourage active participation and group interaction. The materials shall reflect the interests and backgrounds of the participants. (2) Environmental aids and supplies for activities of daily living shall be provided as required by the participant's needs and the goals of the center. #### Regulation .31 Work Stations. *COMAR 10.12.04.31* A. The center shall provide at least one work station for use of nurses, social workers, program assistants, or other appropriate staff and consultants. B. Work stations shall have sufficient storage space for records and to meet the needs of the center. #### Regulation .32 Infection Control. *COMAR 10.12.04.32* There shall be sufficient hand-washing facilities to ensure that employees maintain adequate infection control procedures. #### Regulation .33 Food Service Area. *COMAR 10.12.04.33* A. Whether prepared on-site or off-site, food shall: (1) Be prepared and served under sanitary conditions; and (2) Meet the requirements of COMAR 10.15.03. B. The Department shall approve all plans for the construction and renovation of facilities and equipment in food service areas. C. All food service areas shall include, at a minimum: (1) At least one hand-washing sink; (2) At least one three-compartment sink or one commercial grade dishwashing machine; (3) Surfaces, floors, walls, cabinets, and counters, that is easily cleanable; (4) Adequate and separate storage for dry food goods; (5) Adequate refrigerated storage for perishable and frozen foods; (6) Adequate and separate storage for cleaning products and chemical agents; (7) Adequate and separate facilities for housekeeping of the food service area or areas; (8) A minimum of one Class ABC fire extinguisher, in or adjacent to all food service area or areas; (9) A minimum of one telephone, with posted emergency telephone numbers, close to all food service area or areas; and (10) For new construction, a separate entrance for deliveries and removal of refuse, with exterior storage of refuse near the food service area or areas. D. In centers where food service area or areas are used for activities, the center shall take precautions to prevent participant access to cleaning products and other potentially dangerous utensils or equipment. #### Regulation .34 Bathrooms. *COMAR 10.12.04.34* A. General Requirements. (1) Bathrooms shall be located not more than 30 feet from the primary activity areas. (2) The center shall provide at least one toilet and one hand-washing sink for every 10 participants. Additional toilets and hand-washing sinks may be required based upon the toileting needs of the participants. (3) Bathrooms shall be accessible to individuals in compliance with the requirements of the Americans with Disabilities Act of 1990. (4) The center shall provide individual paper towels, a trash receptacle, soap, and toilet paper in bathrooms at all times. These supplies and equipment shall be accessible to participants at all times. (5) Space and equipment shall be provided in bathrooms, to maintain privacy while cleaning or changing the clothing of participants. B. Change of Clothes. The center shall make arrangements with the family or residential caregiver to store a set of clothing at the center for use if a participant becomes incontinent during his or her stay at the center. C. Drinking water may not be obtained from a bathroom. #### Regulation .35 Laundry Facilities. *COMAR 10.12.04.35* A. Laundry facilities shall be available on-site for use if a participant's clothing becomes soiled while he or she is at the center. B. The area or areas where laundry facilities are located shall be equipped with exhaust ventilation, secure chemical storage, and dryer lint exhaust and control. C. The center shall maintain laundry facilities in a safe and sanitary manner. #### Regulation .36 Water Supply. *COMAR 10.12.04.36* A. Water Supply. A center shall be served by water from an approved public water supply. If an approved public water supply is not available, a private water supply may be used if the Department of the Environment approves the source in accordance with COMAR 26.04.02. B. Loss of Water Supply. The center shall establish written emergency procedures that enable the center to have water in all essential areas in the event of the loss of the normal water supply. C. Adequacy of Water Pressure. The water supply shall be adequate in quantity and be delivered under sufficient pressure to satisfactorily serve fixtures in the center. A minimum pressure of 15 pounds per square inch shall be maintained at top floor fixtures during peak demand period. D. Water Temperature. The water heating equipment shall supply adequate amounts of water as follows: (1) Washing, bathing, and other personal use, not more than 120°F or less than 100°F; and (2) Food preparation, in conformance with COMAR 10.15.03. #### Regulation .37 Plumbing and Sewage. *COMAR 10.12.04.37* A. Plumbing. All plumbing in a center shall be installed and maintained according to all applicable federal, State, and local building codes and sanitation regulations. B. Sewage. A center shall be served by an approved public sewage disposal system, if available. If no approved public sewerage system is available, a private sewage disposal system may be used if the Department of the Environment approves the system according to COMAR 26.04.02. #### Regulation .38 Heating, Air Conditioning, and Ventilation. *COMAR 10.12.04.38* A. Heating. (1) The center shall have a properly maintained and operating central heating system that is capable of maintaining 75°F throughout the participants' section of the building. (2) The heating system shall comply with NFPA 101, Life Safety Code, which is incorporated by reference in COMAR 29.06.01.06, and all applicable State and local codes. (3) A center may not use space heaters or portable heaters unless approved by the State or local fire authority. (4) The center shall ensure that all exposed heating pipes, hot water pipes, and radiators are covered or protected to prevent exposure to participants, staff, and visitors. B. Air Conditioning. The center shall have a properly maintained and operating air conditioning system capable of maintaining a maximum temperature of 81°F throughout the participants' section of the building. C. Ventilation. (1) Existing Centers. The center shall ensure that all rooms and areas have sufficient ventilation to prevent excessive heat, steam, condensation, smoke, or other noxious odors. The center shall provide forced mechanical exhaust or an approved equivalent for: (a) All bathing compartments; (b) Toilet rooms; (c) Designated smoking rooms, if applicable; and (d) Other rooms, as determined by the Department. (2) New Centers. In addition to the requirements in §C(1) of this regulation, new centers shall meet the following minimum ventilation rates: #### Regulation .39 Lighting. *COMAR 10.12.04.39* A. The center shall ensure that lighting levels in all areas are appropriate for the type of activity. B. Glare from windows exposed to direct sunlight shall be kept at a minimum by using window coverings and glare from lights shall be kept at a minimum by using shaded light fixtures. #### Regulation .40 Sanitation. *COMAR 10.12.04.40* A. The center shall have sufficient maintenance and housekeeping personnel to assure that the center is clean, orderly, attractive, and safe at all times. B. The center shall ensure that maintenance and housekeeping activities are completed on a regular basis and according to generally accepted sanitation standards. Maintenance and housekeeping functions may not interfere with the provision of care or the activities program of the center. C. The center shall develop and implement a written plan for preventive maintenance and repair of the center. D. Insects and Rodents. (1) The center shall: (a) Be maintained free of insects and rodents; (b) Maintain control measures to prevent infestation by insects and vermin; and (c) Ensure that all control measures are conducted using approved methods. (2) The use of pesticides shall be controlled so that participants, staff, and visitors are not exposed to fumes or residues. Application of pesticides shall be scheduled at a time when participants are not in the center. E. Refuse. (1) The center shall store refuse in water-tight containers with tight-fitting covers. Containers shall be emptied at frequent intervals and be thoroughly scoured and aired before reuse. (2) The outside storage area for garbage shall be constructed of impervious materials. F. Special Medical Waste. The center shall dispose of special medical waste in accordance with all federal, State, and local laws and regulations. #### Regulation .41 Safety. *COMAR 10.12.04.41* A. Fire Safety. The center shall comply with the provisions of: (1) COMAR 20.06.01; (2) NFPA 101 Life Safety Code, which is incorporated by reference in COMAR 29.06.01.06; and (3) All other applicable federal, State, and local fire codes and regulations. B. A center that is located within a licensed nursing home or hospital shall meet the applicable requirements of NFPA 101 Life Safety Code. C. The center shall ensure that a floor plan with evacuation routes from the center is posted in each separate space, room, and corridor of the center. D. The center shall have at least two well-identified exits. Stairs, ramps, and interior floors shall have nonslip surfaces. Handrails shall be installed on all interior and exterior stairs and ramps. Stairways and hallways shall be well lit and kept free of obstructions. E. The center shall ensure that drugs, cleaning agents, chemicals, pesticides, and other poisonous products are secured for the safety of the participants, staff, and visitors. #### Regulation .42 Smoking. *COMAR 10.12.04.42* A. The center shall prohibit smoking in all indoor areas in accordance with COMAR 09.12.23. B. If smoking is permitted in exterior areas, the center shall establish and implement smoking policies and procedures that minimize the risk of fire. C. The smoking policies and procedures shall include at least the following provisions: (1) The center shall prohibit smoking in any hazardous location where flammable liquids, combustible gases, or oxygen are stored; (2) The center shall designate smoking areas with ashtrays of noncombustible material and safe design; (3) Participants shall be supervised at all times while smoking; and (4) If the center has an exterior designated smoking area, this area may not be located at the front entrance. #### Regulation .43 Sanctions. *COMAR 10.12.04.43* A. If the Department determines that a deficiency or deficiencies exist, the Secretary may impose sanctions against the licensee. B. The Secretary may impose the following sanctions, as appropriate: (1) Direct the licensee to correct the deficiencies in a specific manner or within a specific time frame, or both; (2) Require the center to use the services of a management firm that is approved by the Department; (3) Mandate staffing patterns that specify the number of personnel or personnel qualifications, or both; (4) Appoint a State monitor, as described in Regulation .44 of this chapter; (5) Restrict the number of participants that a center may admit; (6) Impose a civil money penalty; (7) Impose emergency suspension of license; and (8) Deny or revoke a license. C. If the Secretary determines that the licensee has violated a condition or requirement of an imposed sanction the Secretary may revoke the license. D. Grievances. (1) A licensee that is aggrieved by the imposition of a sanction under §B(4)—(8) or C of this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter. (2) A licensee that is aggrieved by the imposition of a sanction under §B(2) and (3) of this regulation may request a show cause hearing before the Director of the Office of Health Care Quality to show cause why these remedies should not be enforced. #### Regulation .44 State Monitor. *COMAR 10.12.04.44* A. If the Department determines that a deficiency or deficiencies exist, the Department may appoint a State monitor who is qualified on the basis of education and experience to oversee correction of the deficiencies. B. The duties of the State monitor shall be specified in a written agreement between the Department and the State monitor and shall include, but are not limited to: (1) Conducting periodic on-site inspections to assess the center's compliance with regulations of this chapter; (2) Making recommendations to achieve compliance with State regulations; and (3) Issuing written reports to the Department and the center detailing the findings of the on-site inspections and the status of recommended actions that the center shall complete to achieve compliance. C. The State monitor shall function for a period of time specified by the Department. The center may request rescission or modification of the duration of the State monitor's appointment at intervals of not less than 120 days from the date of appointment. D. The State monitor may not be an employee of the Department. E. The State monitor's salary shall be: (1) Paid directly by the center; and (2) At least equivalent to the prevailing salary paid by centers for an individual with similar education and experience. #### Regulation .45 Mandated Staffing Pattern. *COMAR 10.12.04.45* A. When the Department determines that a deficiency or deficiencies exist, the Department shall notify the center of the deficiency or deficiencies and may either: (1) Mandate a staffing pattern that specifies the number of personnel or personnel qualifications, or both; or (2) Permit the center the opportunity to correct the deficiencies by a specific date. B. If the center does not correct the deficiency or deficiencies, the Department has the authority to specify the number of personnel or personnel qualifications, or both. C. The center shall comply with the Department's mandated staffing pattern and notify the Department, in writing, when the staffing pattern has been implemented. D. A mandated staffing pattern shall be in effect for the period of time specified by the Department. A center may request rescission or modification of the staffing pattern at intervals of not less than 60 days from the date of imposition of the staffing pattern. #### Regulation .46 Admission Restriction. *COMAR 10.12.04.46* A. If the Secretary determines that a serious health or fire safety deficiency exists in a center, the Secretary immediately may restrict new admissions to the center for not more than a 30-day period. B. Within 7 days after a request by an aggrieved party, a show cause hearing shall be held before the Director of the Office of Health Care Quality to show cause why the admission restriction was not appropriately imposed. C. Within 21 days after admissions are restricted, the center shall take steps to correct the deficiency. D. Unless the Secretary lifts the admissions restriction, within 30 days after admissions are restricted, a hearing shall be held to determine whether the center has taken sufficient measures to correct the deficiency. E. If the Secretary finds that the deficiency still exists, the Secretary may: (1) Continue to restrict admissions for not more than three consecutive 30-day periods; or (2) Revoke the license of the center. #### Regulation .47 Civil Money Penalties. *COMAR 10.12.04.47* A. The Secretary may impose a civil money penalty if a deficiency or an ongoing pattern of deficiencies exists in a center. B. In determining whether a civil money penalty is to be imposed, the Secretary shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The extent to which the deficiency or deficiencies are part of an ongoing pattern during the preceding 24 months; (3) The degree of risk to the health, life, or safety of the participants of the center that is caused by the deficiency or deficiencies; (4) The efforts made by, and the ability of, the center to correct the deficiency or deficiencies; and (5) A center's prior history of compliance. C. If the Department determines that a deficiency or an ongoing pattern of deficiencies exists, the Department shall notify the center of the deficiency or deficiencies and may: (1) Impose a per day civil money penalty until sustained compliance has been achieved; (2) Permit the center the opportunity to correct the deficiencies by a specific date; or (3) Impose a per instance civil money penalty for each instance of violation. D. If the Department permits a center the opportunity to correct the deficiencies by a specific date, and the center fails to comply with this requirement, the Department may impose a per day civil money penalty for each day of violation until correction of the deficiency or deficiencies has been verified and sustained compliance has been maintained. E. If the Department proposes to impose a civil money penalty, the Secretary shall issue an order which shall state the: (1) Deficiency or deficiencies on which the order is based; (2) Amount of civil money penalties to be imposed; and (3) Manner in which the amount of civil money penalties imposed was calculated. F. An order issued pursuant to this regulation shall be void unless issued within 60 days of the inspection or re-inspection at which the deficiency is identified. #### Regulation .48 Amount of Civil Money Penalties. *COMAR 10.12.04.48* A. A civil money penalty imposed under this chapter for potential for more than minimal harm deficiencies may not exceed: (1) $3,000 per instance; or (2) $300 per day for an ongoing pattern of deficiencies until the center is in compliance. B. A civil money penalty imposed under this chapter for actual harm deficiencies may not exceed: (1) $5,000 per instance; or (2) $1,000 per day for an ongoing pattern of deficiencies until the center is in compliance. C. A civil money penalty imposed under this chapter for a serious and immediate threat may not exceed: (1) $10,000 per instance; or (2) $3,000 per day for an ongoing pattern of deficiencies until the center is in compliance. D. In setting the amount of a civil money penalty under this chapter, the Secretary shall consider the following factors: (1) The number, nature, and seriousness of the deficiencies; (2) The degree of risk to the health, life, or safety of the participants of the center caused by the deficiency or deficiencies; (3) The efforts made by the center to correct the deficiency or deficiencies; (4) Whether the amount of the proposed civil money penalty will jeopardize the financial ability of the center to continue operating as a center; and (5) Other factors as justice may require. E. All civil money penalties collected under this chapter shall be paid into the general fund of the State. #### Regulation .49 Civil Money Penalties — Hearings. *COMAR 10.12.04.49* A. A hearing on the appeal shall be held in accordance with the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter. #### Regulation .50 Civil Penalties — Unlicensed Center. *COMAR 10.12.04.50* A. Imposition of Penalty. The Secretary may impose a civil money penalty on a person who manages or operates an unlicensed center as follows: (1) A civil money penalty imposed on a person under this chapter may not exceed $10,000 for each offense; and (2) When a civil money penalty is imposed, the Secretary shall issue an order which includes the: (a) Deficiency or deficiencies on which the order is based; (b) Amount of civil money penalty to be imposed; and (c) Manner in which the amount of civil money penalty was calculated. B. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter. #### Regulation .51 Emergency Suspension. *COMAR 10.12.04.51* A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency action. B. The Department shall deliver a written notice to the center: (1) Informing it of the emergency suspension; (2) Giving the reasons for the action and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and (3) Notifying the center of its right to request a hearing and to be represented by counsel. C. The filing of a hearing request does not stay the emergency action. D. When a license is suspended by emergency action: (1) The center shall immediately return the license to the Department; (2) The center shall stop providing adult day care services immediately; and (3) The licensee shall notify the participants or representatives of the participants of the suspension and make every reasonable effort to assist them in making other arrangements for adult day care services. E. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter. F. Show Cause Hearing. In addition to the right to request a hearing in accordance with Regulation .53 of this chapter, a person aggrieved by the action of the Secretary under this regulation shall be provided with the opportunity for a hearing to show cause why the Department should lift the summary suspension. G. If requested in writing, the show cause hearing shall be held promptly within a reasonable time after the effective date of the order of summary suspension. The time limit for filing an appeal with the Office of Administrative Hearings to obtain an evidentiary hearing shall be tolled by the filing of a request for a show cause hearing. H. The show cause hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the summary suspension. I. The show cause hearing shall be conducted before the Secretary or a designee of the Secretary, who: (1) Shall determine procedural issues; (2) May impose reasonable time limits on each party's oral argument; and (3) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. J. At the conclusion of the show cause hearing, the Secretary or the Secretary's designee may: (1) Affirm the order of summary suspension; (2) Rescind the order of summary suspension; (3) Enter into a consent order; or (4) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. K. After the show cause hearing, if the Secretary or the Secretary's designee decides to continue the summary suspension, the person aggrieved by the decision may request an evidentiary hearing before the Office of Administrative Hearings in accordance with Regulation .53 of this chapter. L. The Office of Administrative Hearings shall conduct a hearing as provided in Regulation .53 of this chapter and issue a proposed decision within the time frames set forth in COMAR 28.02.01. Exceptions may be filed by an aggrieved person pursuant to COMAR 10.01.03. The Secretary shall make a final decision pursuant to COMAR 10.01.03. M. If the Secretary's final decision does not uphold the emergency suspension, the center may resume operation. #### Regulation .52 Denial or Revocation of License. *COMAR 10.12.04.52* A. Denial or Revocation of License. The Secretary, for cause shown, shall notify the center of its decision to deny or revoke the center's license. The denial or revocation shall be stayed if a hearing is requested. B. The Department shall notify the center in writing of the following: (1) The effective date of the denial or revocation; (2) The reason for the denial or revocation; (3) The regulations with which the licensee has failed to comply that form the basis for the denial or revocation; (4) That the center is entitled to a hearing if requested, and to be represented by counsel; (5) That the center shall stop providing services on the effective date of the denial or revocation if the center does not request a hearing; (6) That the denial or revocation shall be stayed if a hearing is requested; and (7) That the center is required to surrender its license to the Department if the denial or revocation is upheld. C. The licensee shall notify the participants or participants' representatives of any final denial or revocation and make every reasonable effort to assist them in making other arrangements for adult day care. D. A person aggrieved by the action of the Secretary under this regulation may appeal the Secretary's action by filing a request for a hearing in accordance with Regulation .53 of this chapter. #### Regulation .53 Hearings. *COMAR 10.12.04.53* A. A request for a hearing shall be filed with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality of the Department, not later than 30 days after receipt of notice of the Secretary's action. The request shall include a copy of the Secretary's action. B. A hearing requested under this chapter shall be conducted in accordance with: (1) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; (2) COMAR 28.02.01; and (3) COMAR 10.01.03. C. The burden of proof is as provided in COMAR 10.01.03.28. D. Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. E. The aggrieved person may file exceptions as provided in COMAR 10.01.03.35. F. A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. ### Chapter 05 — Breast Implantation **Authority:** Health-General Article, §20-114, Annotated Code of Maryland **Administrative History:** Effective date: September 3, 1990 (17:17 Md. R. 2080) #### Regulation .01 Definitions. *COMAR 10.12.05.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Breast implantation” means both: (a) Breast augmentation, the procedure of surgically inserting breast implants beneath a woman's natural breasts; and (b) The type of breast reconstruction that involves surgically inserting a breast implant in the chest area of a woman who has had a mastectomy. (2) “Department” means the Maryland Department of Health. (3) “Physician” means an individual who is authorized under the Medical Practice Act to practice medicine in Maryland and who performs breast implantation surgery in Maryland. #### Regulation .02 Requirements for the Maryland Department of Health. *COMAR 10.12.05.02* The Department shall: A. Provide a standardized written summary in layperson's language that: (1) Contains the information on breast implantation generally contained in the package inserts for breast implants, and (2) Discloses side effects, warnings, and cautions for a breast implantation operation; B. Update as necessary the standardized written summary; C. Provide a statement indicating acknowledgment of receipt of the standardized written summary to be signed by the patient; D. Provide a waiver form describing the conditions under which the usual time requirements of the summary distribution may be waived; and E. Distribute copies of the standardized written summary, the acknowledgment of receipt statement, and the 5-day waiver form to all hospitals, clinics, other facilities, and physicians' offices where breast implantation is performed. #### Regulation .03 Requirements for Physicians. *COMAR 10.12.05.03* A. The standardized written summary provided by the Department shall be provided to the woman by the physician as soon as possible but not later than 5 days before a physician performs a breast implantation operation. B. The physician may provide the standardized written summary less than 5 days before performing breast reconstruction with breast implants only when the following conditions have been met: (1) The woman's breast cancer surgery is scheduled to take place within 5 days of the time she initially consults with a breast cancer surgeon; (2) The woman decides to have breast implant reconstruction at the same time as the breast cancer surgery; (3) At the time of the woman's initial visit with the physician who will perform the breast implant reconstruction, that physician: (a) Gives the woman the Department's standardized written summary; (b) Has the patient sign the statement provided by the Department acknowledging receipt of the summary; and (c) Informs the woman of the relative advantages and disadvantages of having breast implant reconstruction at the same time as cancer treatment; (4) The woman decides to waive the 5-day minimum waiting period and signs the waiver provided by the Department; and (5) A copy of this signed waiver, along with a copy of the signed acknowledgment of receipt form, is placed in the patient's medical record which is used by the physician. C. A physician may not perform breast implantation until a patient has been given the standardized written summary described in Regulation .02A of this chapter. D. A physician who provides a patient with the written summary required under these regulations shall have: (1) The patient sign a statement provided by the Department acknowledging receipt of the summary; and (2) A copy of the signed acknowledgment pursuant to §D(1), of this regulation, placed in the patient's medical record which is used by the physician. E. This regulation is supplemental and additional to any other requirements established by other laws upon a physician and may not be regarded as in derogation or substitution of any requirements now existing upon a physician, such as the need to obtain informed consent for treatment. ## Subtitle 13 — Drugs ### Chapter 01 — Dispensing of Prescription Drugs by a Licensee **Authority:** Health Occupations Article, §§12-102 and 12-102.1, Annotated Code of Maryland **Administrative History:** Effective date: September 19, 1935 **Administrative History:** Chapter, Permits for Sale of Poisons by General Merchants, repealed effective July 10, 1989 (16:13 Md. R. 1421) **Administrative History:** Chapter, Dispensing of Prescription Drugs by a Licensee, adopted effective May 11, 1992 (19:9 Md. R. 879) **Administrative History:** Regulation .03A amended effective March 6, 2000 (27:4 Md. R. 453) **Administrative History:** Chapter revised effective June 22, 2015 (42:12 Md. R. 762) **Administrative History:** Regulation .02B amended effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .03A amended effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .04D, N amended effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .04S adopted effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .05 amended effective March 26, 2018 (45:6 Md. R. 320) #### Regulation .01 Scope. *COMAR 10.13.01.01* This chapter defines the parameters under which a licensee may dispense prescription drugs in accordance with Health Occupations Article, §12-102, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.13.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Dental Examiners, the Board of Physicians, or the Board of Podiatric Medical Examiners. (2) Final Check. (a) “Final check” means the verification of the accuracy and completeness of a filled prescription order by the permit holder before the drug is dispensed to the patient. (b) “Final check” includes the assumption of responsibility for the filled prescription, including verifying the: (i) Appropriateness of the dose; (ii) Accurate expiration date; (iii) Accuracy of the drug dispensed; (iv) Strength of the drug dispensed; (v) Labeling that complies with Health Occupations Article, §12-505, Annotated Code of Maryland; and (vi) Appropriateness of the container in which the drug is dispensed, including child-proof containers where applicable. (3) “Licensee” means the dentist, physician, or podiatrist who is licensed by the appropriate Board to practice in Maryland. (4) “Personally preparing and dispensing” means the licensed dentist, physician, or podiatrist: (a) Is physically present on the premises where the prescription is filled; and (b) Performs a final check of the prescription before it is dispensed to the patient. (5) “Public interest” means the dispensing of prescription drugs by a licensee to a patient when a pharmacy is not conveniently available to the patient. #### Regulation .03 Application for Dispensing Permit. *COMAR 10.13.01.03* A. The licensee shall complete an application on a form approved by the appropriate Board and pay a fee in accordance with the fee schedule for: (1) Physicians at COMAR 10.32.01.12; (2) Podiatrists at COMAR 10.40.03; or (3) Dentists at COMAR 10.44.20. B. The application shall require the following information to indicate that the applicant is personally preparing and dispensing prescription drugs in the public interest: (1) The name, address, and license number of the applicant; (2) An attestation by the applicant that the applicant shall comply with the: (a) Dispensing requirements set forth in Regulation .04 of this chapter; (b) Inspection requirements set forth in Regulation .05 of this chapter; and (c) Statutes and regulations governing dispensing of prescription drugs set forth in Health Occupations Article, Title 12, Annotated Code of Maryland, COMAR 10.19.03, and COMAR 10.34; and (3) The address of each practice location where the applicant dispenses prescription drugs. C. Each permit issued to a licensee expires 5 years after its date of issuance and is renewable upon timely submission of a renewal application in accordance with the requirements set forth in this regulation. The fee schedule set forth in §A of this regulation applies to all renewal applications. D. Continuing Education Requirement. (1) A permit holder shall complete 10 continuing education credits over a 5-year period relating to the preparing and dispensing of prescription drugs as a condition of permit renewal. (2) The continuing education credit requirement shall be implemented in accordance with Ch. 267, §2, Acts of 2012. E. A permit issued to a licensee shall be nontransferable. #### Regulation .04 Dispensing Requirements. *COMAR 10.13.01.04* A. A licensee shall submit an application to the appropriate Board on the form that the Board requires. B. A licensee may not dispense prescription drugs until a written permit is received from the appropriate Board, except that a written permit is not required in order to dispense starter dosages or samples provided without charge. C. A licensee shall personally prepare and dispense prescription drugs. D. Except as provided in Health Occupations Article, §12-102(c)(2)(iii), Annotated Code of Maryland, and §S of this regulation, a licensee shall dispense prescription drugs only to the patients of the licensee. E. A licensee shall comply with the labeling requirements set forth in Health Occupations Article, §12-505, Annotated Code of Maryland. F. A licensee shall comply with the child resistant packaging requirements set forth in Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland. G. A licensee shall comply with drug recalls. H. A licensee shall record the dispensing of the prescription drug on the patient's chart. I. A licensee may not have a substantial financial interest in a pharmacy. J. A licensee shall, except for starter dosages or samples provided without charge, provide the patient with a written prescription. K. A licensee shall maintain for at least 5 years: (1) A separate file for Schedule II prescriptions; and (2) Another file for other prescriptions. L. A licensee shall maintain biennial inventories of all stocks of controlled substances. M. A licensee shall dispense prescription drugs to a patient only when the patient determines that a pharmacy is not conveniently available to the patient. N. In each patient’s chart for each patient to whom prescription drugs are dispensed or in a format readily retrievable, a licensee shall maintain a single form which: (1) Indicates that a pharmacy is not conveniently available to the patient; (2) States that the determination that a pharmacy is not conveniently available was made solely by the patient; and (3) Is signed and dated by the patient before dispensing prescription drugs to the patient for the first time. O. A licensee shall display prominently a sign which informs the patient that prescription drugs can be purchased from the permit holder if the patient determines that a pharmacy is not conveniently available to the patient. P. A licensee may not make any agreement that denies a patient a free choice of pharmacist or pharmacy services. Q. A licensee shall post a sign conspicuously positioned and readable regarding the process for resolving incorrectly filled prescriptions or includes written information regarding the process with each prescription dispensed. R. A licensee shall maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary to prepare and dispense prescriptions properly. S. To the extent permitted by COMAR 10.32.23, a licensed physician may personally prepare and dispense a prescription written by: (1) A physician assistant with whom the physician has a delegation agreement that: (a) Complies with Health Occupations Article, Title 15, Subtitle 3, Annotated Code of Maryland; and (b) Permits the physician assistant to prescribe the drug; and (2) A certified registered nurse practitioner who is: (a) Authorized to practice under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; and (b) Working with the physician in the same practice. #### Regulation .05 Inspection Requirements. *COMAR 10.13.01.05* A. The Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric Medical Examiners shall report annually to the Office of Controlled Substances Administration the names and addresses of its licensees who: (1) Are authorized to personally prepare and dispense prescription drugs; and (2) Have reported to the appropriate Board that they have personally prepared and dispensed prescription drugs within the previous year. B. A licensee shall allow the Office of Controlled Substances Administration to enter and inspect the licensee’s practice locations at all reasonable hours. C. The Office of Controlled Substances Administration shall: (1) Enter and inspect the practice locations of a licensee who holds an initial dispensing permit: (a) Within 6 months after receiving the annual report set forth in §A(1) of this regulation; and (b) At least one more time during the duration of the permit; (2) If a licensee who holds an initial dispensing permit has more than one practice location: (a) Enter and inspect a practice location of the licensee within 6 months after receiving the annual report set forth in §A(1) of this regulation; and (b) Enter and inspect a different practice location at least one time during the duration of the permit; (3) If a licensee who holds a dispensing permit is seeking renewal: (a) Enter and inspect a practice location of a licensee at least two times during the duration of the permit; and (b) If licensee has more than one practice location, enter and inspect two different practice locations during the duration of the permit; (4) If the Office of Controlled Substances Administration finds a deficiency at one practice location of a licensee with multiple practice locations, require the licensee to prepare, sign, and submit an affidavit attesting that all practice locations are in or will be in compliance as a result of the inspection; (5) Report to the Board of Pharmacy a wholesale distributor not licensed in Maryland; and (6) Report the results of the inspections required under §C(1) and (2) of this regulation to the respective board of licensure. D. A licensee shall sign and date an inspection form provided by the Office of Controlled Substances Administration relating to the requirements set forth in Health Occupations Article, §12-102, Annotated Code of Maryland. E. A licensee shall pay a fee in an amount that will produce funds to approximate, but not exceed, the documented costs to the Office of Controlled Substances Administration for inspections, as required by the appropriate Board. F. The Office of Controlled Substances Administration: (1) May suspend inspections of any physician who reports pursuant to Health Occupations Article, §12-102(c)(2)(ii)4L, Annotated Code of Maryland, that the physician has not personally dispensed any prescription medications during the preceding year; and (2) To the extent otherwise required by this regulation, shall resume inspections if that physician later reports that the physician has resumed dispensing activities. #### Regulation .06 Failure to Comply with Dispensing Requirements. *COMAR 10.13.01.06* A licensee who fails to comply with the requirements governing dispensing of prescription drugs shall have the dispensing permit revoked and be subject to disciplinary action by the appropriate licensing board. ### Chapter 02 — Purchase and Distribution of Prescription Drugs and Devices **Authority:** Health-General Article, §21-234; Health Occupations Article, §§12-6C-01(u) and 12-6C-03.1; Annotated Code of Maryland **Administrative History:** Effective date: August 22, 2011 (38:17 Md. R. 1012) #### Regulation .01 Scope. *COMAR 10.13.02.01* This chapter applies to the purchasing and distribution of prescription drugs and devices by the Department for public health purposes. #### Regulation .02 Definitions. *COMAR 10.13.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adulterated” means a drug or device where: (a) Any part of the drug or device is filthy, putrid, or a decomposed substance; or (b) The drug or device was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have: (i) Contaminated the drug or device with filth; or (ii) Caused the drug or device to be injurious to health. (2) “Board” means the State Board of Pharmacy. (3) “Department” means the Maryland Department of Health. (4) “Misbranded” means a drug or device where: (a) The drug’s or device’s: (i) Labeling is false or misleading in any way; or (ii) Labeling or packaging does not conform with Health-General Article, §21-248, Annotated Code of Maryland; (b) The drug or device is in package form and does not bear a label that contains the name and place of business of the manufacturer, packer, or distributor; (c) Any word, statement, or other information required under Health-General Article, Title 21, Subtitle 2, Annotated Code of Maryland, to appear on the drug’s or device’s labeling is not placed prominently on the labeling in a manner that is: (i) Conspicuous as compared with other words, statements, designs, or symbols on the labeling; and (ii) In terms likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (d) The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate directions for the use of the drug or device; (e) The drug’s or device’s labeling does not include, in whatever manner and form that may be necessary to protect the user of the drug or device, adequate warnings against: (i) The use of the drug or device by anyone suffering from a pathological condition that may cause the drug’s or device’s use to be dangerous to health; (ii) The use of the drug or device by a child if the use by a child may be dangerous; and (iii) Unsafe dosages, methods of administration, or duration of administration of the drug or device; (f) The drug or device is dangerous to health when used in the dosage, with the frequency, or for the duration specified, recommended, or suggested in the labeling of the drug or device; or (g) The trademark, trade name, imprint, symbol, or other identifying mark of another drug or any likeness of any of these markings of another drug or device is placed on the drug or device or its container with the intent to defraud. (5) “Pedigree” means a record of the tracking of a drug or device through the supply chain, with each trading partner authenticating the drug or device upon receipt and transfer. (6) “Prescription device” means a device required by federal law or regulation to be dispensed only by a prescription. (7) Prescription Drug. (a) “Prescription drug” means a drug required by federal law or regulation to be dispensed only by a prescription. (b) “Prescription drug” includes: (i) A biological product; and (ii) Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug, and Cosmetic Act. (c) “Prescription drug” does not include: (i) Blood and blood components intended for transfusion; or (ii) Biological products that are also medical devices. (8) “Public health purposes” includes the purpose of controlling communicable diseases or environmental health hazards. (9) “Secretary” means the Secretary of Health. #### Regulation .03 Personnel. *COMAR 10.13.02.03* A. The Secretary shall designate one or more Department employee representatives to be responsible for the purchase and distribution of prescription drugs and devices for public health purposes. B. A designated Department representative shall: (1) Be a merit or contractual employee of the Department employed full time in a managerial level position; (2) Be aware of and knowledgeable about the policies and procedures pertaining to the purchase and distribution of prescription drugs and devices for public health purposes, including applicable State and federal laws; (3) Be actively involved in, and aware of, the daily operation of the Department’s purchasing and distribution of prescription drugs and prescription devices; (4) Be responsible for: (a) Storage and handling as set forth in Regulation .04 of this chapter; (b) Record-keeping requirements as set forth in Regulation .06 of this chapter; and (c) Making records available for inspection; and (5) Meet the following qualifications: (a) Is 21 years old or older; (b) Except for an authorized absence such as sick leave or vacation leave, is physically present at the Department during regular business hours; (c) Does not have any convictions for a violation of any federal, State, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and (d) Does not have any convictions for a felony under federal, State, or local laws. #### Regulation .04 Storage and Handling. *COMAR 10.13.02.04* A. Storage Facility. A designated Department representative shall store, hold, or handle prescription drugs and devices in a facility that: (1) Is constructed to facilitate: (a) Cleaning; and (b) Maintenance; (2) Has storage areas designed to provide adequate: (a) Equipment; (b) Humidity control; (c) Lighting; (d) Sanitation; (e) Security conditions; (f) Space; (g) Temperature; and (h) Ventilation; (3) Has a secured separate quarantine area for storage of prescription drugs or devices that are: (a) Adulterated; (b) Damaged; (c) Deteriorated; (d) In immediate or sealed secondary containers that have been opened; (e) Misbranded; or (f) Outdated; (4) Is maintained in a clean and orderly condition; and (5) Is free from insects, rodents, birds, or vermin. B. Storage. (1) A designated Department representative shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements: (a) If any, on the labeling of the prescription drug or device; or (b) Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF). (2) If no storage requirements are established for a prescription drug or device, a designated Department representative shall hold the prescription drug or device at a controlled room temperature, as defined in an official compendium as set forth in §B(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected. (3) A designated Department representative shall document proper storage of prescription drugs and devices in accordance with the: (a) Use of manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs; and (b) Record-keeping requirements in Regulation .06 of this chapter for stored prescription drugs and devices. C. Examination of Materials. (1) Upon receipt of a prescription drug or device, a designated Department representative shall visually examine each outside shipping container to prevent the acceptance of: (a) An adulterated prescription drug or device; or (b) A prescription drug or device that is otherwise unfit for distribution. (2) A designated Department representative shall examine each prescription drug or device container, as required under §C(1) of this regulation, to ascertain whether there is any damage to the container that would suggest possible contamination or other damage to the contents. (3) A designated Department representative shall carefully inspect each outgoing shipment: (a) For identity of the prescription drug or device being shipped; and (b) To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions. (4) Each unit of the Department, such as a local health department, that receives delivery of the prescription drug or device shall meet the requirements of this regulation for storage, security, and record keeping. (5) A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for an incoming and an outgoing prescription drug or device. D. Security of the Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored is secure from unauthorized entry as follows: (1) Access from outside the premises is: (a) Kept to a minimum; and (b) Limited to authorized personnel as determined by the designated Department representative; and (2) The storage area is equipped with: (a) A security system that provides protection against theft and diversion; (b) An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; and (c) A security system that protects the integrity and confidentiality of data and documents. E. Authorized Access of Storage Area. A designated Department representative shall ensure that the area where prescription drugs and devices are stored: (1) Has a means in place to make the data and documentation required under this chapter readily available to the Board, an agent of the Board, or federal or State law enforcement officials; and (2) Allows for inspection by a Board representative. #### Regulation .05 Quarantine, Destruction, and Return of Prescription Drugs and Devices. *COMAR 10.13.02.05* A. A designated Department representative shall quarantine and physically separate prescription drugs and devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs and devices until the quarantined and separated prescription drugs and devices are destroyed or returned to their supplier for disposal. B. A designated Department representative shall identify, mark, quarantine, and physically separate from other prescription drugs and devices those prescription drugs and devices whose immediate or sealed outer or sealed secondary containers have been opened or used, until the prescription drugs and devices are either destroyed or returned to their supplier for disposal. C. Prescription Drugs. (1) If the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, then a designated Department representative shall destroy the prescription drug or return the prescription drug to the supplier, unless examination, testing, or other investigation proves that the prescription drug meets appropriate standards of safety, identity, strength, quality, and purity. (2) In determining whether the conditions under which a prescription drug has been returned by a local health department or a health care provider cast doubt on the prescription drug's safety, identity, strength, quality, or purity, a designated Department representative shall consider, at a minimum, the: (a) Conditions under which the prescription drug has been held, stored, or shipped before or during the return of the prescription drug; and (b) Condition of the prescription drug and its container, carton, or labeling, as a result of storage or shipping. D. Prescription Devices. (1) If the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, then a designated Department representative shall destroy or return the prescription device to the supplier, unless examination, testing, or other investigation proves that the prescription device meets appropriate standards of safety, identity, strength, and quality. (2) In determining whether the conditions under which a prescription device has been returned by a local health department or a health care provider cast doubt on the prescription device's safety, identity, or quality, a designated Department representative shall consider, at a minimum, the: (a) Conditions under which the prescription device has been held, stored, or shipped before or during return of the prescription device; and (b) Condition of the prescription device and the device’s container, carton, or labeling, as a result of storage or shipping. E. A designated Department representative shall follow the record-keeping requirements in Regulation .06 of this chapter for outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs and devices. #### Regulation .06 Record Keeping. *COMAR 10.13.02.06* A designated Department representative shall: A. Establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs and devices; B. Include the following information in the records required under §A of this regulation: (1) The source of a prescription drug or device, including the: (a) Name and principal address of the seller or transferor; and (b) Address of the location from which a prescription drug or device was shipped; (2) The identity and quantity of the prescription drugs and devices received and distributed or disposed of; (3) The dates of receipt and distribution or other disposition of the prescription drugs and devices; and (4) If required by Health Occupations Article, §12-6C-10, Annotated Code of Maryland, the pedigrees for prescription drugs that are wholesale distributed outside the normal distribution channel; C. Establish, maintain, and adhere to written policies and procedures addressing the: (1) Receipt, security, storage, inventory, and distribution of prescription drugs and devices; (2) Identifying, recording, and reporting of losses or thefts; and (3) Correcting of errors and inaccuracies in inventories; D. Include in the written policies and procedures established according to §C of this regulation the following: (1) A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first; (2) Procedures to be followed for handling a recall and withdrawal of a prescription drug or device due to: (a) An action initiated at the request of the United States Food and Drug Administration (FDA) or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control; (b) A voluntary action by the manufacturer to remove a defective or potentially defective prescription drug or device from the market; and (c) An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design; (3) A procedure to ensure that the Department is prepared for, protected against, and able to handle a crisis that affects security or operation of a facility if any of the following situations occur: (a) Strike; (b) Fire; (c) Flood; (d) Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland; (e) Terrorist activities; (f) Natural disaster; or (g) Other situations of local, State, or national emergency; (4) A procedure to ensure that outdated prescription drugs and devices are segregated from other prescription drugs and devices and either returned to the manufacturer or destroyed; (5) A procedure for: (a) The disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities; and (b) Appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and (6) A procedure for: (a) Identifying, investigating, and reporting prescription drug inventory discrepancies involving counterfeiting, suspicion of counterfeiting, contraband, or suspicion of contraband; and (b) Upon discovery, the reporting of a discrepancy within 5 business days to the Board; E. Make available inventories and records for inspection and copying by authorized federal or State law enforcement agency officials for a period of 3 years after the date of creation of the inventories and records; F. Keep the records described in this regulation readily available for inspection by authorized federal, State, or local law enforcement agency officials during the retention period, either: (1) At the inspection site; or (2) So as to be immediately retrievable by computer or other electronic means; G. Within 5 working days of a request by an authorized official of a federal, State, or local law enforcement agency, make available for inspection records kept at a central location apart from the inspection site and not electronically retrievable; H. Establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs or devices or counterfeiting and contraband or suspected counterfeiting and contraband activities to the Board and the FDA; I. Maintain a system for the mandatory reporting of significant inventory losses of prescription drugs and devices where it is known or suspected that diversion is occurring to: (1) The Board; (2) The FDA; and (3) Where applicable, the U.S. Drug Enforcement Administration; and J. Consider the following factors when determining if there has been a significant inventory loss: (1) The schedule of the missing items; (2) The abuse or misuse potential of the missing items; (3) The abuse or misuse potential in the Department’s area of the missing substance; (4) The quantity missing in relation to the total quantity purchased, for example, one tablet per (5) Whether this is the first time a potentially significant inventory loss has occurred; (6) Whether this loss was reported to local law enforcement authorities; and (7) Whether there is a significant resale value of the missing items. ### Chapter 03 — Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs **Authority:** Health-General Article, §§2-104(b), 13-3501, and 13-3502, Annotated Code of Maryland **Administrative History:** Effective date: June 17, 2019 (46:12 Md. R. 544) #### Regulation .01 Scope. *COMAR 10.13.03.01* This chapter applies to all licensed health care practitioners who may prescribe an opioid overdose reversal drug to an individual who: A. May be at an elevated risk of experiencing an opioid overdose including, but not limited to, an individual who: (1) Is receiving an opioid for chronic pain; (2) Is receiving an opioid and a prescription for a benzodiazepine; or (3) Has an opioid use disorder; or B. Resides or spends time with an individual who: (1) Is prescribed opioids; (2) Misuses opioids; or (3) Has an opioid use disorder. #### Regulation .02 Definitions. *COMAR 10.13.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Co–prescribed” means, with respect to an opioid overdose reversal drug, the practice of prescribing the drug in conjunction with an opioid prescription for a patient at an elevated risk of overdose. (2) “Department” means the Maryland Department of Health. (3) “Monitored prescription drug” means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. (4) “Opioid overdose reversal drug” means a drug that: (a) Rapidly reverses the respiratory depressant effects of an opioid medication; and (b) Is approved by the federal Food and Drug Administration for the treatment of a known or suspected opioid overdose. (5) “Prescribing licensed health care provider” means an individual who is authorized by law to prescribe a monitored prescription drug. (6) “Risk factor” means a characteristic, condition, behavior, or any variable that increases the likelihood of developing a disease or injury. (7) “Secretary” means the Secretary of the Maryland Department of Health. (8) Targeted Patient Population. (a) “Targeted patient population” means an individual likely to experience or witness an opioid overdose. (b) “Targeted patient population” includes, but is not limited to, an individual who: (i) Is being prescribed opioids for acute, if appropriate, or chronic pain; (ii) Is being treated for an opioid use disorder; (iii) Is receiving a prescription for an opioid and a benzodiazepine; or (iv) Resides or spends time with an individual who is prescribed opioids, misuses opioids, or has an opioid use disorder. #### Regulation .03 General Provisions. *COMAR 10.13.03.03* A. When determined appropriate by the prescribing licensed health care provider, targeted patient populations may be co-prescribed an opioid overdose reversal drug, if the individual is at an elevated risk of experiencing an opioid overdose by virtue of belonging to one or more categories of the targeted patient population. B. Responsibilities of the Prescribing Licensed Health Care Provider. (1) Risk Monitoring. (a) It is suggested that the licensed health care provider routinely assess patients for their risk of being likely to experience or witness an opioid overdose. (b) The prescriber may utilize additional sources of information for determining a patient’s opioid overdose risk including, but not limited to: (i) Checking the Maryland Prescription Drug Monitoring Program; (ii) Reviewing medical records; and (iii) Soliciting family input, if appropriate. (2) Education. If a patient is assessed to be at risk of an opioid overdose, the prescriber may educate the patient about, including but not limited to, the following areas: (a) The risks of an opioid overdose; and (b) How to identify and respond to an opioid overdose. (3) Documentation. Licensed health care providers should document education and clinical services related to the provision of an opioid overdose reversal drug in their patients’ medical records in accordance with the standard of care. #### Regulation .04 Additional Guidelines. *COMAR 10.13.03.04* The Secretary may make the following additional clinical guidance available on the Department’s website: A. Any available opioid overdose reversal drug formulations, corresponding prescribing templates, and any standing order for these drugs; and B. Any other applicable information deemed necessary by the Secretary. ### Chapter 04 — Emergency Use Epinephrine Program **Authority:** Health-General Article, §§2-104 and 13-7A-03, Annotated Code of Maryland **Administrative History:** Effective date: May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .01 amended effective July 12, 2021 (48:14 Md. R. 538) **Administrative History:** Regulation .02B amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .03 amended effective July 12, 2021 (48:14 Md. R. 538); February 16, 2026 (53:3 Md. R. 122) #### Regulation .01 Scope. *COMAR 10.13.04.01* This chapter applies to employees of food service, recreation, or wellness facilities on the premises of an institution of higher education as defined in Education Article, §10-101, Annotated Code of Maryland, and employees of food service facilities, as defined in COMAR 10.15.03, who voluntarily participate in the Program. #### Regulation .02 Definitions. *COMAR 10.13.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Affiliated individual” means an individual who is 18 years old or older who has been designated in writing by a participating facility to serve either as a health supervisor or as a certificate holder. (2) “Agent” means an individual who: (a) Is 18 years old or older; (b) Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department; and (c) Is designated in writing by a certificate holder to administer emergency use epinephrine in an emergency situation. (3) “Anaphylaxis” means a sudden, severe, and potentially life-threatening allergic reaction that occurs when an individual is exposed to an allergen. (4) “Applicant” means an individual applying for a Certificate for Emergency Epinephrine. (5) “Certificate for emergency epinephrine” means a certificate issued by the Maryland Department of Health to an individual employed or designated by a participating facility to obtain, store, and administer emergency use epinephrine. (6) “Certificate holder” means an individual who is authorized by the Maryland Department of Health to obtain, store, and administer emergency use epinephrine to be used in an emergency situation. (7) “Department” means the Maryland Department of Health. (8) “Eligible institution” means an institution of higher education that has a food service facility or a recreation and wellness facility on the premises and that otherwise meets the requirements of this chapter. (9) “Emergency use epinephrine” means a portable, disposable drug delivery device or product approved by the federal Food and Drug Administration that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation. (10) “Food service facility” has the meaning stated in COMAR 10.15.03. (11) “Health supervisor” means an individual who: (a) Provides health services for a participating facility; and (b) Is licensed by the State as a: (i) Physician; (ii) Certified nurse practitioner; or (iii) Registered nurse. (12) “Participating facility” means a recreation or wellness facility at an eligible institution or a food service facility, including a food service facility at an eligible institution, in the State that voluntarily participates in the Program. (13) “Successfully completed” means to pass a written examination with a grade of 75 percent or higher. #### Regulation .03 Emergency Epinephrine. *COMAR 10.13.04.03* A. An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant: (1) Is employed by a participating facility; (2) Is 18 years old or older; and (3) Has successfully completed, at the expense of the participating facility, an emergency epinephrine educational training program approved by the Department. B. The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes: (1) Designation of agents and affiliated individuals; (2) The name of the approved emergency epinephrine educational training program; and (3) Procedures to: (a) Store emergency use epinephrine; (b) Maintain the emergency use epinephrine in a secure manner; (c) Report use of emergency use epinephrine according to §L of this regulation; (d) Train an emergency epinephrine certificate holder and agent annually; and (e) Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years. C. A provider of an emergency epinephrine educational training program shall meet the requirements of COMAR 10.16.07.15C and D. D. An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner. E. The Department shall: (1) Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation; (2) Deny the issuance of a certificate for emergency epinephrine to an applicant who does not meet the requirements in §§A and B of this regulation; (3) Revoke or suspend the certificate for emergency epinephrine of an individual who does not meet the requirements in §§A and B of this regulation; (4) Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation; (5) Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and (6) On or before January 31 of each year, publish a report summarizing the information obtained from the reported uses of emergency use epinephrine at participating facilities according to §L of this regulation. F. A physician licensed to practice medicine in the State may prescribe emergency use epinephrine in the name of a certificate holder. G. A pharmacist licensed to practice pharmacy in the State, or a physician, may dispense emergency use epinephrine under a prescription issued to a certificate holder. H. A certificate holder may: (1) On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for emergency use epinephrine; and (2) Possess and store prescribed emergency use epinephrine. I. A participating facility: (1) Shall ensure that there is a written plan for the emergency epinephrine program that: (a) Is approved annually, in writing, by a health supervisor; (b) Is on file at the participating facility and is available for inspection; and (c) Includes at a minimum: (i) The name, title, and license number of the health supervisor; (ii) Information on the emergency epinephrine educational training program used; (iii) Procedures for disseminating information to staff on the emergency epinephrine program; (iv) Procedures for the proper storage and handling of medication; (v) Procedures for the use of emergency services and 911 services; and (vi) Procedures for documenting incidents involving the administration of emergency use epinephrine by a certificate holder in accordance with §L of this regulation; (2) Shall ensure that a certificate holder who is employed by, or a designated affiliated individual of, the participating facility complies with all provisions of this chapter; (3) Shall provide the Department with access to records and documents required under this chapter; (4) Shall designate in writing the certificate holders who will be responsible for the storage, maintenance, and control of the supply of emergency use epinephrine; (5) May not obtain or store emergency use epinephrine unless the participating facility has at least two certificate holders; and (6) Shall maintain a copy of the certificate issued to a certificate holder under §E of this regulation for at least 3 years. J. Certificate Holders. (1) Subject to §I(4) of this regulation, a certificate holder may obtain: (a) A prescription for a supply of emergency use epinephrine from a licensed physician as provided in §F of this regulation; and (b) A supply of emergency use epinephrine from a licensed pharmacist or a licensed physician as provided in §G of this regulation. (2) A certificate holder shall store a supply of emergency use epinephrine obtained under §J(1) of this regulation: (a) In accordance with the manufacturer’s instructions; and (b) In a location that is readily accessible to certificate holders and agents in an emergency situation. K. In an emergency situation when physician or emergency medical services are not immediately available, a certificate holder or agent may administer emergency use epinephrine to an individual who is experiencing or believed in good faith by the certificate holder or agent to be experiencing anaphylaxis. L. A participating facility shall ensure that an incident that occurred on the premises of the facility that involved the administration of emergency use epinephrine by a certificate holder or agent is reported: (1) Immediately to the health supervisor and, in the case of a minor, to the minor’s parent or guardian; and (2) To the Department within 5 business days of the incident on a form prescribed by the Department. ### Chapter 05 — AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes *Repealed* **Administrative History:** Effective date: June 17, 1955 **Administrative History:** Chapter “Purchase of Exempt Narcotic Preparations” repealed effective August 25, 1978 (5:17 Md. R. 1329) **Administrative History:** Regulations .01—.06 “AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes” adopted effective October 12, 1992 (19:20 Md. R. 1815) **Administrative History:** Regulation .02B amended effective January 12, 2001 (28:1 Md. R. 26) **Administrative History:** Chapter repealed effective March 26, 2018 (45:6 Md. R. 320) ### Chapter 06 — Acceptance of Oral Prescriptions for Certain Narcotic Drugs *Repealed* **Administrative History:** Effective date: November 10, 1955 **Administrative History:** Chapter repealed effective August 25, 1978 (5:17 Md. R. 1330) ### Chapter 07 — Sale of Dihydrocodeinone or any of its Salts *Repealed* **Administrative History:** Effective date: April 1, 1960 **Administrative History:** Chapter repealed effective August 25, 1978 (5:17 Md. R. 1330) ### Chapter 08 — Sale of Needles and Syringes or Other Paraphernalia **Authority:** Health-General Article, §2-104(b), Annotated Code of Maryland **Administrative History:** Effective date: December 21, 1970 **Administrative History:** Regulation .01 amended effective March 6, 2000 (27:4 Md. R. 454) #### Regulation .01 Identification of Purchaser, and Record of Sale. *COMAR 10.13.08.01* The sale of needles and syringes or other paraphernalia shall be made by the pharmacist only in good faith to patients showing proper identification and indication of need. ### Chapter 09 — Sale of Nitrous Oxide *Repealed* **Administrative History:** Effective date: September 21, 1971 **Administrative History:** Regulations .01—.03 repealed effective January 21, 1991 (18:1 Md. R. 29) ### Chapter 10 — Prescribing, Administering, and Dispensing of Amphetamines and Methamphetamines *Repealed* **Administrative History:** Effective date: August 7, 1973 **Administrative History:** Chapter revised effective July 13, 1979 (6:14 Md. R. 1207) **Administrative History:** Chapter revised effective January 21, 1991 (18:1 Md. R. 29) **Administrative History:** Chapter repealed effective December 18, 1995 (22:25 Md. R. 1962) ### Chapter 11 — Sale of Drugs by Vending Machine **Authority:** Health-General Article, §21-1111(c), Annotated Code of Maryland **Administrative History:** Effective date: October 10, 1994 (21:20 Md. R. 1732) #### Regulation .01 Exemption to Allow Sale of Drugs in Vending Machine. *COMAR 10.13.11.01* A. A person may sell by vending machine or other similar device, nonprescription drugs that alleviate pain in the quantities and form specified in §B of this regulation, and which are exempted from the prohibition of Health-General Article, §21-1111, Annotated Code of Maryland. B. Nonprescription drugs that alleviate pain may be sold by vending machine or other similar devices in: (1) Solid oral dosage form only; and (2) Single dose quantities of not more than three tablets or capsules per dose. ### Chapter 12 — Impoundment and Disposal of Drugs and Prescription Records **Authority:** Health-General Article, §21-1113, Annotated Code of Maryland **Administrative History:** Effective date: June 24, 2002 (29:12 Md. R. 927) #### Regulation .01 Definitions. *COMAR 10.13.12.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Authorized prescriber” means: (a) A licensed dentist, licensed physician, licensed podiatrist, licensed veterinarian, or to the extent permitted under Health Occupations Article, §8-601, Annotated Code of Maryland, certified nurse midwife; (b) A certified nurse practitioner to the extent permitted under Health Occupations Article, §8-508, Annotated Code of Maryland; or (c) Another individual authorized by law to prescribe prescription or nonprescription drugs or devices. (2) “Board” means a health occupation licensing board: (a) Authorized to issue a permit, license, or certificate under Health Occupations Article, Annotated Code of Maryland; and (b) That has regulatory authority over the permit holder or authorized prescriber who is responsible for the drugs or prescription records subject to impoundment. (3) “Department” means the Maryland Department of Health, or its authorized agent. (4) “Drug” means a prescription drug or device or a nonprescription drug, as defined in Health-General Article, §21-1113(a), Annotated Code of Maryland. (5) “Impoundment order” means an order issued by the Department to impound drugs or prescription records in accordance with Health-General Article, §21-1113, Annotated Code of Maryland, and this chapter. (6) “Permit holder” means a holder of, or applicant for: (a) A pharmacy permit, manufacturer's permit, or distributor's permit issued by the State Board of Pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland; or (b) A dispensing permit issued by the board under the authority of Health Occupations Article, §12-102(c)(2), Annotated Code of Maryland. (7) “Prescription records” means records maintained by a permit holder or authorized prescriber which identify a patient and any medical information relating to that patient. (8) “Transfer” means the release of impounded drugs or prescription records by the department to a transferee. (9) “Transferee” means a permit holder or authorized prescriber to whom impounded drugs or prescription records are transferred in accordance with this chapter. #### Regulation .02 Requirements for an Impoundment Order. *COMAR 10.13.12.02* A. The Department may issue an impoundment order if: (1) A permit holder's permit or authorized prescriber's license has expired or has been revoked or suspended; (2) An application for a permit or license has been denied; (3) A board has: (a) Determined that the permit holder or authorized prescriber failed to comply with a board order, letter of surrender, or law regarding the disposition of drugs or prescription records; and (b) Requested that the Department impound the drugs or prescription records; (4) The drugs pose an imminent threat to the public health, safety, or welfare; or (5) The confidentiality of the prescription records is in imminent danger of being compromised. B. The Department may issue an impoundment order based on: (1) On-site observation by a law enforcement official, the Department, or other regulatory official of drugs that pose imminent danger to the public health, safety, or welfare; (2) On-site observation by a law enforcement official, the Department, or other regulatory official that the confidentiality of prescription records is in imminent danger of being compromised; (3) Investigation by the Department or law enforcement authority sufficient to prove that drugs are posing an imminent danger to the public health, safety, or welfare, or that the confidentiality of prescription records is in imminent danger of being compromised; or (4) Review of the board's licensing records that indicate the permit holder or authorized prescriber does not have the licensing or permit authority to possess drugs or prescription records. C. Before execution of an impoundment order issued in accordance with Health-General Article, §21-1113(c)(1), Annotated Code of Maryland, the Department shall: (1) Attempt to serve written notice of the impoundment on the permit holder or authorized prescriber by certified mail at the last known address in the board's licensing files; and (2) Provide the permit holder or authorized prescriber with an opportunity to: (a) Avoid impoundment by allowing the permit holder or authorized prescriber to dispose of the drugs or prescription records in a manner acceptable to the Department; (b) Review the nature, type, and amount of information upon which the Department issued the impoundment order; and (c) Avoid impoundment by providing the Department with information upon which the Department could reasonably conclude that the impoundment is not warranted. D. Notice of Order of Impoundment. (1) If the Department issues an impoundment order in accordance with Health-General Article, §21-1113(c)(2), Annotated Code of Maryland, the Department shall attempt to contact the permit holder or authorized prescriber at the last known address or telephone number contained in the board's licensing files before executing the impoundment order. (2) Posting. (a) If the Department is unsuccessful in contacting the permit holder or authorized prescriber before the execution of the impoundment order, the Department shall post the impoundment order in a conspicuous place at the site of the drugs or prescription records. (b) The posted impoundment order shall contain information regarding: (i) The location of the impounded drugs or prescription records; and (ii) An individual to contact for further information. #### Regulation .03 Disposition of Impounded Drugs or Prescription Records. *COMAR 10.13.12.03* A. If the Department executes an impoundment order against a permit holder or authorized prescriber, the Department shall: (1) Arrange for the drugs or prescription records to be kept in a secure location; (2) Ensure that any location which stores impounded drugs provides the necessary temperature controls and equipment to properly maintain the drugs; and (3) Provide the permit holder or authorized prescriber with a list of all drugs and prescription records impounded. B. Reclamation or Transfer. (1) The permit holder or authorized prescriber may petition the Department to reclaim or transfer the impounded drugs or prescription records within 30 days of the date of the impoundment order. (2) In order to reclaim or receive a transfer of impounded drugs or prescription records, the permit holder, authorized prescriber, or transferee shall demonstrate: (a) Capability to maintain the impounded drugs or prescription records in compliance with all relevant State and federal laws; (b) Applicable licensing or permit authority to obtain possession of the impounded drugs or prescription records; and (c) If the impounded drugs or prescription records are to be transferred to a transferee, the existence of an express written agreement between the permit holder or authorized prescriber and the transferee, permitting the Department to release the impounded drugs or prescription records to the transferee. (3) If the Department grants a petition to reclaim or transfer impounded drugs or prescription records, the petitioner shall arrange for the removal and transport of the impounded drugs or prescription records. (4) Notice of Denial. (a) If the Department denies a petition to reclaim or transfer impounded drugs or prescription records, the Department may destroy or transfer the impounded drugs or prescription records in accordance with §C(2) of this regulation at least 15 days after the Department has attempted to serve notice by certified mail at the last known address of the permit holder or authorized prescriber. (b) The notice shall indicate that the Department: (i) Has denied the petition; and (ii) Intends to destroy or transfer the impounded drugs or prescription records. C. Disposition of Drugs or Prescription Records if No Petition is Filed. (1) If the permit holder or authorized prescriber has not petitioned the Department within 30 days as provided in §B of this regulation, the Department may destroy or transfer the impounded drugs or prescription records. (2) The Department shall destroy or transfer: (a) Impounded drugs in accordance with all relevant State and federal laws, including Health-General Article, §21-1113(i), Annotated Code of Maryland; and (b) Prescription records in accordance with Health-General Article, §§4-403 and 21-1113(i), Annotated Code of Maryland. D. Reimbursement. (1) The permit holder or authorized prescriber shall reimburse the Department for the reasonable expenses relating to the collection, storage, and disposition of impounded drugs or prescription records. (2) The Department may require that the permit holder or authorized prescriber provide advance reimbursement to the Department as a precondition to granting a petition to reclaim or transfer impounded drugs or prescription records. ## Subtitle 14 — Cancer Control ### Chapter 01 — Cancer Registry **Authority:** Health-General Article, §§2-104, 18-104, 18-203 and 18-204, Annotated Code of Maryland; 42 U.S.C. §280(e) **Administrative History:** Effective date: September 28, 1992 (19:19 Md. R. 1707) **Administrative History:** Regulation .01 amended effective April 21, 1997 (24:8 Md. R. 616) **Administrative History:** Regulation .02B amended effective April 26, 1993 (20:8 Md. R. 723); April 21, 1997 (24:8 Md. R. 616); June 23, 2003 (30:12 Md. R. 788) **Administrative History:** Regulation .04 amended effective April 21, 1997 (24:8 Md. R. 616) **Administrative History:** Regulation .04C amended effective June 23, 2003 (30:12 Md. R. 788) **Administrative History:** Regulation .05B amended effective June 23, 2003 (30:12 Md. R. 788) **Administrative History:** Regulation .06B, D amended effective June 23, 2003 (30:12 Md. R. 788) **Administrative History:** Chapter revised effective March 22, 2010 (37:6 Md. R. 478) **Administrative History:** Regulation .01 amended effective January 13, 2011 (38:1 Md. R. 11); April 15, 2013 (40:7 Md. R. 611); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .02B amended effective January 13, 2011 (38:1 Md. R. 11); April 15, 2013 (40:7 Md. R. 611); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .02-1 adopted effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .02-1 amended effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .05C amended effective January 13, 2011 (38:1 Md. R. 11) **Administrative History:** Regulation .06B amended effective January 13, 2011 (38:1 Md. R. 11) **Administrative History:** Regulation .07G adopted effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .07G amended effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .08A amended effective January 13, 2011 (38:1 Md. R. 11) #### Regulation .01 Scope. *COMAR 10.14.01.01* This chapter establishes a cancer registry within the Department, defines key terms, details the information to be contained in a cancer report, and specifies requirements of reporting facilities, nursing facilities, assisted living programs, and general hospice care programs. In addition, this chapter identifies requestors authorized to receive confidential data, allows a fee to be charged for data reports, and incorporates by reference the Maryland Cancer Registry Data Use Manual and Procedures (July 2016). #### Regulation .02 Definitions. *COMAR 10.14.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Assisted living program” has the meaning stated in COMAR 10.07.14.02B. (2) “Cancer registry” means a computerized system to register all cases of reportable human cancer or reportable human central nervous system (CNS) tumors of Maryland residents and nonresidents diagnosed or treated in Maryland. (3) “Cancer report” means a one-time abstract from one or more of the following documents maintained by a reporting facility, nursing facility, assisted living program, or general hospice care program of each new case of reportable human cancer or CNS tumor diagnosed or treated, and any other case of reportable human cancer or CNS tumor initially diagnosed or treated for time periods as designated by the Secretary: (a) Medical record; (b) Pathology report; and (c) Radiological report. (4) Case of a Reportable Human CNS Tumor. (a) “Case of a reportable human CNS tumor” means an identified human tumor, irrespective of histologic type or behavior, occurring as a primary tumor in any of the following sites or subsites with International Classification of Diseases for Oncology, Third Edition (ICD-O-3) topography codes C70.0 — C72.9 and C75.1 — C75.3: (i) The brain; (ii) The meninges; (iii) The spinal cord; (iv) The cauda equina; (v) A cranial nerve; (vi) The pituitary gland; (vii) The pineal gland; or (viii) The craniopharyngeal duct. (b) “Case of a reportable human CNS tumor” includes all benign and uncertain behavior tumors of the CNS (ICD-10-CM Codes D18.02, D32.0 — D33.9, D35.2 — D35.4, D42.0 — D43.9, D44.3 — D44.5, Q85.00 — Q85.09 and D49.6, and all tumors of the CNS of benign and uncertain behavior with ICD-O-3 codes of “0” or “1”), which includes codes from: (i) The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM); and (ii) The International Classification of Diseases for Oncology, Third Edition (ICD-O-3). (5) “Case of reportable human cancer” means the identification of a human cancer from the following list, which includes codes from the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) and the International Classification of Diseases for Oncology, Third Edition (ICD-O-3): (a) All malignant neoplasms with ICD-10-CM Codes C00 — C43.9, C44.00, C44.09, C44.10_, C44.19_, C44.20_, C44.29_, C44.30_, C44.39_, C44.40, C44.49, C44.50_, C44.59_, C44.60_, C44.69_, C44.70_, C44.79_, C44.80, C44.89, C44.90, C44.99, C45._ — C96._, or with ICD-O-3 behavior code of “3”, including genital skin cancer of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other sites of skin cancer with ICD-O-3 topography codes C44.0 — C44.9 with one of the following ICD-O-3 histologies: (i) M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin; (ii) M-8010 — 8046 Epithelial carcinomas of skin; (iii) M-8050 — 8084 Papillary and squamous cell carcinomas of skin (C44.02, C44.12_, C44.22_, C44.32_, C44.42, C44.52_, C44.62_, C44.72_, C44.82, C44.92); or (iv) M-8090 — 8110 Basal cell carcinomas (C44.01, C44.11_, C44.21_, C44.31_, C44.41, C44.51_, C44.61_, C44.71_, C44.81, C44.91); (b) All malignant neoplasms with the following ICD-10-CM codes where ICD-O-3 behavior is “3” and ICD-O-3 histologies are reported except as follows: (i) If there is evidence of multiple foci, lymph node involvement, or metastasis, C37 — Thymoma (M-8580); (ii) C7A.020 — Malignant carcinoid tumor of the appendix (M-8240); (iii) C54.1 — Endometrial stroma, low grade (M-8931); (iv) If there is evidence of multiple foci, lymph node involvement, or metastasis, D48.1 — Stromal Tumor of the digestive system (GIST 8639); (v) D48.60 — Phylloides tumor (M-9020); (vi) D45 — Polycythema (M-9950); (vii) D47.Z9 — Plasmacytoma (M-9731, M-9734); (viii) D47.3 — Essential thrombocythemia (M-9962), D46.0, D46.1, D46.20, D46.21, D46A, D46B — Low grade myelodysplastic syndrome lesions (M-9980), D46.22 — High grade myelodysplastic syndrome lesions (M-9983), D46.C — Myelodysplastic syndrome with 5q deletion (M-9986), D469 — Myelodysplastic syndrome, unspecified (M-9975), D47.1 — Myelofibrosis with myeloid metaplasia (primary myelofibrosis) (M-9961), D47.Z1 — post-transplant lymphoproliferative disorder (M-9989), C94.40, C94.41, C94.42, D47.9, D47.Z9 — lympho and myeloproliferative disease (M-9960, M-9970); (ix) C88.2 — Alpha and gamma heavy chain disease (M-9762) or Franklin disease (M-9763); (x) C88.0 — Waldenstrom macroglobulinemia (M-9761); (xi) D46.4 — Refractory anemia (M-9980); or (xii) D46.1 — Refractory anemia with ringed sideroblasts (M-9982), refractory anemia with excess blasts (M-9983), or refractory anemia with excess blasts in transformation (M-9984); (c) All cases of carcinoma in situ with ICD-10-CM Codes D00._ — D09.9, D47.Z2, D49.511 — D49.519, D49.59, D78.31 — D78.34, and D89.40 — D89.49, or with ICD-O-3 behavior code of “2”, including genital skin cancers of the vagina, clitoris, vulva, prepuce, penis, and scrotum and excluding other skin cancers with ICD-O-3 topography codes C44.0_ — C44.9_ with one of the following ICD-O-3 histologies: (i) M-8000 — 8005 Neoplasms, malignant, not otherwise specified of skin; (ii) M-8010 — 8046 Epithelial carcinomas of skin; (iii) M-8050 — 8084 Papillary and squamous cell carcinomas of skin; and (iv) M-8090 — 8110 Basal cell carcinomas; or (d) All cases of intraepithelial neoplasia with ICD-O-3 histology code of M-8077/2: (i) Including squamous intraepithelial neoplasia of the larynx (LIN), vagina (VAIN), vulva (VIN), and anus (AIN) (ICD-10-CM codes D02.0, D07.2, D07.1, and D01.3; and ICD-O-3 topography codes C52, C51, and C21._); and (ii) Excluding squamous intraepithelial neoplasia of the cervix (CIN III) and glandular intraepithelial neoplasia of the prostate (PIN) (ICD-10-CM codes D06._ and D07.5; and ICD-O-3 topography codes C53 and C61.9). (6) “Computerized file” means an electronic data file using software approved for use by the Secretary, containing complete cancer report information transferable to a master electronic database system maintained by the Department. (7) “Department” means the Maryland Department of Health or a designee. (8) “Freestanding ambulatory care facility” has the meaning stated in Health-General Article, §19-3B-01, Annotated Code of Maryland. (9) “Freestanding laboratory” means a facility, place, establishment, or institution which performs a laboratory examination for a person, authorized by law to request the examination, in connection with the diagnosis of a reportable human cancer or CNS tumor, and is licensed by the State pursuant to COMAR 10.10.03, and: (a) Not under the administrative control of a hospital; or (b) Under the administrative control of a hospital for a diagnosis of reportable human cancer or CNS tumor of a nonhospitalized patient. (10) “General hospice care program” has the meaning stated in COMAR 10.07.21.02. (11) “Hospital” means a facility which is licensed by the State pursuant to COMAR 10.07.01. (11-1) “Maryland Cancer Registry Data Use Manual and Procedures” means the document that describes the Maryland cancer registry procedures for release of cancer data and that outlines the procedures to obtain both non-confidential aggregate data and confidential individual-level data. (12) “Nursing facility” has the meaning stated in COMAR 10.07.02.01B. (13) “Physician” means an individual who: (a) Practices medicine, as defined in Health Occupations Article, §14-101, Annotated Code of Maryland; and (b) Diagnoses or treats a case of reportable human cancer or a reportable human CNS tumor at a practice located in Maryland. (14) “Reporting facility” means any of the following: (a) A hospital, freestanding laboratory, freestanding ambulatory care facility, or therapeutic radiological center; or (b) A physician who has care of or has diagnosed a case of reportable human cancer or reportable human CNS tumor for a nonhospitalized patient not otherwise reported. (15) “Secretary” means the Secretary of Health or a designee of the Secretary. (16) “Therapeutic radiological center” means a facility or institution: (a) Performing radiological treatment for a person authorized by law to request the treatment in connection with a reportable human cancer or a reportable human CNS tumor; and (b) Licensed or registered by the State pursuant to COMAR 10.05.03 and not under the administrative control of a hospital. #### Regulation .02-1 Incorporation by Reference. *COMAR 10.14.01.02-1* The Maryland Cancer Registry Data Use Manual and Procedures (Maryland Department of Health, July 2016) is incorporated by reference. #### Regulation .03 Establishment of a Cancer Registry. *COMAR 10.14.01.03* There is a cancer registry established within the Department, whose purpose is to collect reportable human cancer data and reportable human CNS tumor data to further the cancer control goals of the State. #### Regulation .04 Cancer Control Goals of the State. *COMAR 10.14.01.04* A. The cancer control goals of the State are to reduce the incidence and mortality of reportable human cancer and reportable human CNS tumors and racial, ethnic, gender, age, and geographic disparities in reportable human cancer and CNS tumor incidence and mortality in Maryland, by: (1) Advancing the understanding of reportable human cancer and reportable human CNS tumor demographics; (2) Describing reportable human cancer and reportable human CNS tumor sources, causes, risk factors, preventive measures, diagnostic tests, screening tests, treatment, and survival; and (3) Evaluating the cost, quality, efficacy, and appropriateness of diagnostic, therapeutic, rehabilitative, and preventive services and programs related to reportable human cancer and reportable human CNS tumors. B. Research that will further the cancer control goals of the State is research whose protocols have been reviewed by Department staff who have found that the research will: (1) Advance scientific knowledge or advance knowledge of clinical practice related to cancer; (2) Have approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses; (3) Have one or more investigators who have training and experience with the approaches and methods; and (4) Be conducted in a scientific environment likely to contribute to the success of the research. #### Regulation .05 Content of a Cancer Report. *COMAR 10.14.01.05* A cancer report shall contain the following information, using the standard nomenclature contained in the North American Association of Central Cancer Registries' Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary: A. Reasonably obtained patient demographic information, including risk factors; B. Information on the industrial or occupational history of an individual with cancer, to the extent such information is available; C. Relevant information on the: (1) Initial diagnosis, including the date of the diagnosis; (2) Initial treatment; (3) Extent of the disease by the end of the first hospitalization; and (4) Extent of the disease within 2 months of diagnosis, if the information is available to the reporting facility, nursing facility, assisted living program, or general hospice care program; D. Facility and other provider identification information; and E. Other requirements as considered necessary by the Secretary. #### Regulation .06 Reporting Requirements. *COMAR 10.14.01.06* A. A reporting facility shall submit a: (1) Cancer report to the Secretary in a computerized file containing standard information required by the Secretary; (2) Computerized file not less than quarterly; and (3) Completed report of any new individual case of a reportable human cancer or reportable human CNS tumor not later than 6 months after diagnosis or treatment. B. A nursing facility, an assisted living program, or a general hospice care program shall submit a cancer report containing information that is under the control of the facility to the Secretary if the Secretary requests a cancer report on a patient who has been a resident of the nursing facility, assisted living program, or general hospice care program. #### Regulation .07 Confidentiality of Cancer Reports. *COMAR 10.14.01.07* A. Information obtained under this chapter is not a medical record under Health-General Article, §4-301, Annotated Code of Maryland, but is subject to the confidentiality requirements of Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland. B. The Secretary may release confidential data to: (1) An institution or individual researcher for medical, epidemiological, health care, or other cancer-related or CNS tumor-related research approved by the Secretary and the Department's Institutional Review Board (IRB) in order to further the cancer control goals of the State set forth in Regulation .04 of this chapter; (2) A reporting facility which: (a) Routinely submits information on cases of reportable human cancer or reportable human CNS tumors to the cancer registry; (b) Has been formally accepted as a participant in the cancer registry system; and (c) Requests data relating to patients reported by the facility; (3) An out-of-State cancer registry or cancer control agency which requests routine data if the: (a) Patient is a resident of the other state; and (b) Other state has authority to provide equivalent information on Maryland residents to this State; (4) Each county health officer and the Baltimore City Commissioner of Health; and (5) Another governmental agency performing its lawful duties pursuant to State or federal law. C. The Secretary may release confidential information, subject to: (1) A determination by the Secretary that a recipient of the information disclosed will maintain the confidentiality of the disclosed information; and (2) An agreement signed by the Secretary and by the recipient of the confidential information that the recipient of the information will maintain the confidentiality of the disclosed information. D. The Secretary shall release confidential data to a requestor in response to a written request only, in accordance with Health-General Article, §§4-101 and 4-102, Annotated Code of Maryland. E. A reporting facility that in good faith submits a cancer report to the Secretary is not liable in any cause of action arising from the submission of the cancer report to the Secretary. F. The use or publication of any statistics, information, or other material that summarizes or refers to confidential records in the aggregate, without disclosing the identity of any person who is the subject of the confidential record is not subject to the provisions of Health-General Article, §4-102, Annotated Code of Maryland. G. The Secretary shall release cancer data in accordance with the procedures outlined in the Maryland Cancer Registry Data Use Manual and Procedures. #### Regulation .08 Authority and Requirements of the Secretary. *COMAR 10.14.01.08* A. To assure compliance by a reporting facility, nursing facility, assisted living program, or general hospice care program with Regulation .05 of this chapter, the Secretary may, upon advance notice, inspect a representative sample of medical records, pathology reports, or radiological reports maintained by the facility of cases of reportable human cancer and reportable human CNS tumors. B. The Secretary may charge a reasonable fee to cover the cost of providing data reports to appropriate requestors, as allowed by COMAR 10.01.08.04. All applicable fees shall be paid in full in advance of filling the request. C. After receiving all necessary information to support a request to release cancer registry data, the Secretary shall act in a timely manner and decide on the request with one of the following outcomes: (1) Final approval; (2) Interim approval, if the request has been accepted with one or more conditions which shall be met before final approval is granted; or (3) Disapproval. D. The Secretary, in accordance with State Government Article, §2-1246, Annotated Code of Maryland, shall submit an annual report to the Governor and General Assembly on the activities of the cancer registry, including use of cancer registry data. E. Nothing in this chapter is intended to limit or otherwise restrict the Secretary from obtaining cancer report information on Maryland residents from sources located either inside or outside the State. ### Chapter 02 — Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment **Authority:** Health-General Article, §§2-102, 2-104, and 2-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.12 under new Chapter, Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment, adopted as an emergency provision effective March 31, 1993 (20:8 Md. R. 715); Regulations .03 and .10 amended as an emergency provision effective May 24, 1993 (20:12 Md. R. 995); amendments to Regulation .10 expired June 30, 1993; adopted permanently effective September 13, 1993 (20:18 Md. R. 1430) **Administrative History:** Regulations .01—.12 repealed and new Regulations .01—.20 adopted effective December 5, 1994 (21:24 Md. R. 1988) **Administrative History:** Chapter revised effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .02B amended as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .03 amended effective April 21, 2008 (35:8 Md. R. 805) **Administrative History:** Regulation .03A amended as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .03A amended effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .08H, I adopted as an emergency provision effective August 1, 2006 (33:21 Md. R. 1672); emergency status extended at 34:4 Md. R. 396; emergency status expired May 1, 2007; adopted permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .08J adopted effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Chapter revised as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); revised permanently effective April 19, 2010 (37:8 Md. R. 616) **Administrative History:** Regulation .01B amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .02B amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .02B amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .03A, G amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .03B, E amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .03C, G amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .04 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .04A amended effective July 2, 2018 (45:13 Md. R. 666) **Administrative History:** Regulation .04A, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521); May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .04-1 adopted effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .04-2 adopted effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .05A amended effective August 20, 2012 (39:16 Md. R. 1080); July 2, 2018 (45:13 Md. R. 666) **Administrative History:** Regulation .05A, B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .05A, D amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .06A amended effective July 2, 2018 (45:13 Md. R. 666) **Administrative History:** Regulation .06A, B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .06A, D amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .07 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .07A amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .07F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .08 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .08 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .09 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .09C, G amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .09E, G amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .10 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .10B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .10E, F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .11 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .11E, F amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .12 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .12C, D amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .12D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .13A, E amended effective April 13, 2015 (42:7 Md. R. 569); May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .13D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .14 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .14A, B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .14E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .15A, B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .15B amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .16 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .17 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .17D amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .18 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .19A, B amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .20A amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .21 amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .22 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .22A, D amended effective May 18, 2020 (47:10 Md. R. 517) #### Regulation .01 Scope. *COMAR 10.14.02.01* A. This chapter defines the reimbursed services for the diagnosis and treatment of breast cancer, cervical cancer, or precancerous cervical lesions, outlines the requirements for patient eligibility, and outlines the reimbursement and billing procedures for the reimbursed services. B. This chapter also defines the: (1) Responsibilities and duties of the Department, the participating local health department, the hospital-coordinated breast and cervical cancer screening program, the health care provider who determines patient eligibility and refers patients to the Program, and the following participating providers: (a) Physician; (b) Physician assistant; (c) Certified nurse midwife; (d) Nurse practitioner; (e) Nurse anesthetist; (f) Physical therapist; (g) Pharmacy; (h) Hospital; (i) Medical supply company; (j) Home health services provider; (k) Medical laboratory; (l) Freestanding ambulatory surgical center; and (m) Occupational therapist; and (2) Process for termination from the Program and the procedure for appealing termination. #### Regulation .02 Definitions. *COMAR 10.14.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Admission” means the formal acceptance by a hospital of a patient who is to be provided with room, board, and medically necessary services in an area of the hospital where the patient stays at least overnight. (2) “Ambulatory surgical center” means a distinct, Medicare-certified entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization. (3) “Annual gross income” means the total amount received per year from all sources before taxes are withheld. (4) “Applicant” means an individual who has applied to be eligible to have certain health care costs associated with the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion paid for by the Department. (5) “Biopsy” means the removal and microscopic examination of tissue from the living human body, performed to establish a precise diagnosis. (6) “Breast reconstruction” means surgery performed after the removal of a breast as a result of breast cancer to reestablish symmetry between the two breasts. (7) “Certified nurse anesthetist” means a registered nurse who: (a) By reason of certification under COMAR 10.27.06, may practice in Maryland under the terms of those regulations; or (b) Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. (8) “Certified nurse midwife” means a registered nurse who: (a) By reason of certification under COMAR 10.27.05, may practice in Maryland under the terms of those regulations; or (b) Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. (9) “Certified nurse practitioner” means a registered nurse who: (a) By reason of certification under COMAR 10.27.07, may practice in Maryland under the terms of those regulations; or (b) Meets the certification requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. (10) “Cervical carcinoma in-situ” means cancer that involves only the intraepithelial layer of the cervix. (11) “Clinical breast examination” is a physical examination of the breast performed by a qualified health professional for the purpose of detecting breast cancer. (12) “Clinically significant mass” means the presence of a discrete, dominant, palpable lump that raises the level of concern by either a patient or a provider. (13) “Controlled clinical trial” means a research study that: (a) Is conducted with cancer patients to evaluate the safety and effectiveness of a new treatment; (b) Is conducted after basic research in laboratory and animal studies have been well tested, and researchers have reason to believe that the new treatment will be as good as, or better than, current standard treatment; (c) Is reviewed for medical ethics, patient safety, and scientific merit by a research institution; (d) Includes an informed consent in which the patient is given information about the study and the potential benefits and risks; and (e) Involves review of the protocol and progress of the study and provides for monitoring the data and the safety of the patient during and after the study by researchers at places other than the institution at which the study is conducted. (14) “Department” means the Maryland Department of Health. (15) “Diagnosis” means a histopathologic finding of breast cancer, cervical cancer, or a precancerous cervical lesion in a biopsy specimen. (16) “Direct supervision” means that the physical therapist employer is physically present in the same area of the facility as the physical therapy assistant who provides service. (17) “Disposable medical supplies” means consumable medical items with minimal or no potential for reuse. (18) “Durable medical equipment” means equipment which satisfies all of the following requirements: (a) Can withstand repeated use; (b) Is used to serve a medical purpose; and (c) Is appropriate for use in the home. (19) “Eligible patient” means an applicant who has been determined to meet certain general, medical, health insurance, and financial criteria. (20) “Excisional biopsy” means the removal of the entire tumor mass for cytologic examination. (21) “Experimental drug” means a drug or biological not: (a) Approved by the Food and Drug Administration for the treatment of breast cancer or cervical cancer; and (b) Used under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by: (i) The National Institutes of Health (NIH) or one of the NIH’s centers or cooperative groups; (ii) The Food and Drug Administration through an investigational new drug exemption; (iii) The Department of Veterans Affairs; or (iv) A qualified nongovernmental research entity as identified in guidelines issued by the NIH. (22) “Experimental treatment” means a medical procedure or service for breast cancer, cervical cancer, or a precancerous cervical lesion that is not performed under the protocol of a peer-reviewed, Phase-III controlled clinical trial approved by: (a) The National Institutes of Health (NIH) or one of the NIH's centers or cooperative groups; (b) The Food and Drug Administration through an investigational new drug exemption; (c) The Department of Veterans Affairs; or (d) A qualified nongovernmental research entity as identified in guidelines issued by the NIH. (22-1) “Explanation of benefits” means the statement sent to a patient or provider, or both, in a health plan that lists: (a) The health care services provided; (b) The amounts paid by the plan; and (c) The total amount billed to the patient. (23) “Family” means the unit comprised of the applicant or the applicant and one or more of the following: (a) Spouse; (b) A financially dependent child; or (c) A financially dependent relative. (24) “Freestanding ambulatory surgical center” means a unit capable of providing ambulatory surgical services which is not located in a hospital setting and which is: (a) Certified by Medicare through the Health Care Finance Administration (HCFA) regional office to furnish ambulatory surgical services directly to patients; and (b) Licensed by the State. (25) “Homebound” means the status of a patient who is confined to the home due to a medical condition. (26) “Home health services provider” means a public or private agency or organization, or part of any agency or organization, that: (a) Meets one of the following licensure requirements: (i) Is licensed pursuant to Health-General Article, §§19-401—19-408, Annotated Code of Maryland; (ii) If the entity is part of a hospital or related institution located in Maryland, is licensed pursuant to Health-General Article, §§19-301—19-359, Annotated Code of Maryland; (iii) If the entity is located outside of Maryland, is legally authorized to provide home health services in the jurisdiction in which the service is provided; or (iv) Is a registered nurse licensed pursuant to Health Occupations Article, §§8-101 and 8-301—8-315, Annotated Code of Maryland, with a contractual agreement with the Department to provide skilled nursing care; (b) Provides nursing or physical therapy services in the home; and (c) Meets the requirements for participation in Medicare. (27) “Hospital” means an institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the jurisdiction in which the service is provided. (28) “Initial physical therapy evaluation” means the determination of the condition of the patient by a physical therapist through the administration of appropriate tests and a written case history on the first visit. (29) “Innovator multiple source drug” has the meaning set forth at 42 U.S.C. §1396r-8(k)(7), as amended, which is incorporated by reference. (30) “Insurer” means a private carrier, nonprofit health service plan, or health maintenance organization that administers or provides reimbursement for health care benefits on an expense-incurred basis. (31) “Intermittent basis” means a service which is furnished on or at medically predictable and recurring intervals. (32) “Invasive cervical cancer” means cancer which has spread beyond the intraepithelial layer of the cervix or beyond to other body tissues and organs. (33) “Invoice” means a: (a) Form issued or approved by the Department for use by a provider in submitting bills for payment; or (b) Bill issued by a manufacturer or wholesaler to the provider which indicates proof of purchase and the price paid by the provider. (34) “Legend drug” means a substance used as a medicine which is prescribed by a licensed health care provider in accordance with federal or State law. (35) “Local health department” means the Baltimore City or a county-wide organization providing health services operated by the local health officer and under the supervision of the Department. (36) “Mammogram” means an X-ray of the breast that is performed to detect breast cancer. (37) “Maryland Health Insurance Plan (MHIP)” means the nonprofit entity established under Insurance Article, §§14-501—14-509, Annotated Code of Maryland, to provide affordable, comprehensive health coverage for medically uninsurable Maryland residents. (38) “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act which provides comprehensive medical and other health-related care for eligible and medically needy low income individuals. (39) “Medical case manager” means the participating physician or participating nurse practitioner who is responsible for making the medical decisions about the course of diagnosis and treatment for an eligible patient. (40) “Medical laboratory” means a licensed or certified facility operated for the examination of material derived from the human body, by one or more scientific disciplines, for the purpose of obtaining information that may be used to aid in the diagnosis, treatment, and management of breast and cervical cancer. (41) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (42) “Needle biopsy” means the removal of tissue from a solid mass with a needle. (43) “Needle localization” means the application of radiologically guided needles to isolate breast lesions preoperatively. (44) “Negative mammogram” means the X-ray revealed: (a) Nothing of medical significance to comment on; (b) A finding which is non-significant, but which may need to be described; or (c) A finding which is probably non-significant, but which may need to be described and which suggests the need for short interval follow-up. (45) “Occupational therapist” means an individual licensed by the Maryland Board of Occupational Therapy Practice or similarly licensed in the state in which the service is provided. (46) “Oncologist” means a physician who specializes in the treatment of cancer. (47) “Over-the-counter drug” means a substance used as a medicine that does not require a prescription under federal or State law. (48) “Participating health care provider” means a local health department, hospital, or a participating: (a) Certified nurse midwife; (b) Freestanding ambulatory surgical center; (c) Home health services provider; (d) Hospital; (e) Medical laboratory; (f) Medical supply company; (g) Nurse anesthetist; (h) Nurse practitioner; (i) Pharmacy; (j) Physical therapist; (k) Physician; (l) Physician assistant; (m) Occupational therapist; or (n) Other appropriate health care providers. (49) “Part-time basis” means services usually furnished during several visits per week, but not exceeding one visit per discipline per day, unless unusual circumstances are documented by the physician, which are reasonable and necessary to the treatment of breast and cervical cancer. (50) “Patient contribution amount” means the amount of money required by an individual's health insurance policy to be paid by the individual for a given medical service received, excluding the deductible. (51) “Pharmacist” means an individual licensed to practice pharmacy in Maryland. (52) “Pharmacy” means an establishment or institution requiring a permit in accordance with Health Occupations Article, Title 12, Annotated Code of Maryland. (53) “Phase-III controlled clinical trial” means a research study using an experimental drug or treatment which: (a) Has been shown to be effective in the treatment of breast or cervical cancer; and (b) May be compared with current standard treatment to evaluate which is more effective. (54) “Physical therapist” means an individual licensed or registered by the Maryland Board of Physical Therapy Examiners or similarly licensed or registered in the state in which the service is provided. (55) “Physical therapist assistant” means an individual licensed as a physical therapy assistant, working under the direct supervision of a physical therapist, and performing those physical therapy procedures that are assigned by a physical therapist within the scope of Health Occupations Article, Title 13, Annotated Code of Maryland. (56) “Physical therapy aide” means a non-licensed individual in the employ of a physical therapist. (57) “Physician” means an individual who is licensed to practice medicine in the jurisdiction in which the service is provided. (58) “Physician assistant” means an individual who: (a) Is licensed to practice medicine under the supervision of a physician under Health Occupations Article, Title 15, Annotated Code of Maryland; or (b) Meets the licensure requirements in the jurisdiction in which the service is provided, if the service is provided out-of-State. (59) “Prescriber” means a participating health care provider licensed to prescribe legend drugs in the state in which the service is provided. (60) “Prescription” means a written order for medication, medical supplies, or equipment signed by the prescriber. (61) “Program” means the Breast and Cervical Cancer Diagnosis and Treatment Program within the Department established to: (a) Reimburse for breast and cervical cancer diagnostic and treatment services provided by participating health care providers to eligible patients; and (b) Pay for MHIP coverage, if available, for eligible patients in lieu of providing direct reimbursement to participating health care providers. (62) “Progress note” means a dated, written notation which summarizes facts about the patient care given and the patient response during a given period of time that: (a) Specifically addresses the established goals of treatment; (b) Is consistent with the patient plan of care; (c) Is written immediately following each visit; and (d) Is part of the permanent patient record. (63) “Radiological examination of a breast surgical specimen” means an X-ray of the surgically removed tissue to ensure that the specimen contains the area of suspicion. (64) “Release of patient information” means a Departmental consent form signed by the patient granting permission to certain individuals to allow the release of certain medical and demographic information for the purpose of follow-up, reimbursement, and medical case management. (65) “Resident” means an individual who is currently living in, and intends to remain living within, Maryland. (66) “Single source drug” means a drug that is: (a) Available from only one producer or distributor; and (b) Produced or distributed under an original new drug application approved by the Food and Drug Administration, including a drug marketed by a producer or distributor operating under the new drug application. (67) “Stage I breast cancer” means a tumor 2 centimeters or less in greatest dimension without regional lymph node or distant metastasis. (68) “Staging” means the categorization of a cancer according to tumor size, regional lymph node involvement, and metastasis to distant areas in the body. (69) “Treatment” means the medical management and care of a patient for breast cancer, cervical cancer, or a precancerous cervical lesion. (70) “Utilization control agent” means the organization responsible for reviewing the use of hospital services to determine medical necessity and lengths of stay according to applicable professional standards. #### Regulation .03 Patient Eligibility. *COMAR 10.14.02.03* A. To be eligible to have a covered service reimbursed under the Program, an applicant shall: (1) Be a resident; (2) Be screened for breast cancer or cervical cancer, or both, by a: (a) Hospital; (b) Local health department; or (c) Health care provider; (3) Be found to have an eligible medical condition as described in §B of this regulation; (4) Meet the health insurance criteria specified in §C of this regulation; (5) Meet the financial eligibility criteria of an annual gross income that is not more than 250 percent of the federal poverty guidelines, as amended, which are incorporated by reference and updated periodically in the Federal Register by the U.S. Department of Health and Human Services; and (6) Receive a medical service only from participating health care providers for breast cancer diagnosis, breast cancer treatment, cervical cancer diagnosis, or cervical cancer or precancer treatment, or any combination of these services. B. A medical condition which may render an applicant medically eligible includes the following: (1) A mammogram, or breast ultrasound, or other diagnostic breast imaging requiring further diagnosis; (2) A clinical breast examination requiring further diagnosis; (3) A Pap test, or human papilloma virus test, or other approved cervical cancer screening test requiring further diagnosis; (4) A breast biopsy which indicates the need for further diagnosis or treatment; or (5) A cervical biopsy which indicates the need for further diagnosis or treatment. C. Health insurance statuses which may render an applicant eligible include the following: (1) The applicant is not currently covered by health insurance, including Medical Assistance; (2) The applicant is covered by Medicare which: (a) Does not provide reimbursement for the covered medical procedure or service; (b) Has a deductible for the year that has not been met; or (c) Has a patient contribution amount for the reimbursed medical procedure or service that the applicant is required to pay; or (3) The applicant has health insurance other than Medical Assistance or Medicare which: (a) Does not provide reimbursement for the covered medical procedure or service; (b) Requires that a deductible be paid by the applicant for the covered medical procedure or service; (c) Reimburses at a rate lower than the Medical Assistance approved rate in the State; or (d) Has a patient contribution amount for the reimbursed medical procedure or service that the applicant is required to pay; (4) The applicant is enrolled in one of the following Medical Assistance programs: (a) Family Planning; (b) Primary Adult Care (PAC); (c) Specified Low Income Medicare Beneficiary (SLMB); or (d) Qualified Medicare Beneficiary (QMB). D. An applicant is not eligible if: (1) The applicant is enrolled in a Medical Assistance program other than those listed in §C(4) of this regulation; (2) During diagnosis or treatment of breast or cervical cancer, the applicant becomes enrolled in a Medical Assistance program other than those cited in §C(4) of this regulation; or (3) Any of the criteria established in §§A—D of this regulation are not met. E. An applicant is responsible for the following: (1) Furnishing factual information regarding the applicant’s eligibility, including but not limited to verifying documents regarding financial eligibility and the applicability of health insurance; (2) Completing, which may include the applicant providing the applicant's social security number, and signing the application form, provided that the Program informs the applicant that: (a) The applicant's disclosure of the applicant's social security number on the application is voluntary; (b) The Program's request for the applicant's social security number is authorized by federal law under the Social Security Act (42 U.S.C. 405(c), as amended); and (c) The applicant's social security number will be used only for the Program's administrative purposes; and (3) Completing and submitting a Medical Assistance application when notified by the Program that the applicant is considered potentially eligible. F. Social Security Number Collection. (1) An applicant is not required to have or disclose a social security number to be eligible for Program benefits. (2) An applicant's disclosure of the applicant's social security number on the application form is voluntary. (3) The Program's request for the applicant's social security number is authorized by federal law under the Social Security Act at 42 U.S.C. §405(c)(2)(C)(i) and (vi), as amended. (4) The Program may only use the social security number provided by an applicant to establish the identity of the applicant for administrative purposes. (5) The Program may request a copy of an applicant's social security card for administrative purposes. G. An eligible patient is responsible for the following: (1) Keeping the Program, local health department, hospital, or health care provider who determines the patient’s eligibility for the Program informed of any change in health insurance status; (2) Selecting and using only a participating health care provider; and (3) Signing the release of patient information form for the Program developed and approved by the Department. #### Regulation .04 Physician Services. *COMAR 10.14.02.04* A. To be considered a participating physician in the Program, the provider shall: (1) Provide a medical procedure or service related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion; (2) Have a current license to practice medicine in Maryland or a jurisdiction bordering Maryland; (3) Agree to accept, for each covered medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: (a) The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or who has insurance that does not provide coverage for a reimbursed procedure or service; (b) The reimbursement rate approved by the insurer plus the payment of the outstanding deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a reimbursed procedure or service; (c) The reimbursement rate approved by Medicare plus the payment of the outstanding deductible and the patient contribution amount by the Department for an eligible patient who is covered by Medicare; or (d) For an eligible patient who has insurance that provides reimbursement for a covered procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the current Medical Assistance approved rate in the State plus the payment of the outstanding deductible by the Department; (4) Agree to abide by the provisions set forth in §A of this regulation by signing and sending to the Department the designated Departmental form; (5) Agree not to bill an eligible patient, who is uninsured or is covered by Medicare or other insurance, for an additional charge for the reimbursed medical procedure performed or service provided; (6) Agree to: (a) Be the medical case manager for an eligible patient; or (b) Coordinate the reimbursed medical procedure or service with the designated medical case manager and submit the result of the procedure to the medical case manager; (7) Agree to the following medical guidelines: (a) That a negative mammogram alone is not sufficient to evaluate a clinically significant mass, and to perform or arrange for further diagnostic evaluation of the mass; (b) That a surgeon shall examine the patient and make the final determination of further diagnostic and treatment procedures needed when a needle biopsy performed by a non-surgeon is negative for cancer; (c) To perform or arrange for needle localization of the mass before excisional biopsy; (d) To perform or arrange for radiological examination of the breast surgical specimen after biopsy to accurately identify the mass; (e) To refer an eligible patient with a mammography assessment recommending biopsy to a surgeon for evaluation and a decision regarding the ultimate course of action; (f) To implement the diagnostic tests or procedures required for cancer staging determination in keeping with the best interests of the patient and to determine staging on the cancer found; (g) To consult an oncologist before any treatment is initiated for Stage I or greater breast cancer or invasive cervical cancer; and (h) To consult with a radiation oncologist if radiation treatment is a medical option; (8) Agree to maintain the results of the reimbursed medical procedures performed as set forth in §E(6)—(9) of this regulation; (9) Agree to maintain administrative and health records, including medical records, to document compliance with this chapter for a minimum of 6 years and, upon request, allow the Department access to the records; and (10) Place no restriction on the eligible patient's right to choose a provider. B. An eligible medical provider may be, but is not limited to, one of the following: (1) Anesthesiologist; (2) Clinical-anatomical or cytopathological pathologist; (3) Diagnostic, therapeutic, or nuclear radiologist; (4) Family practitioner; (5) Medical internist; (6) Medical or gynecological oncologist; (7) Obstetrician-gynecologist; or (8) Surgeon. C. Reimbursed medical procedures include, but are not limited to, the following: (1) Breast cancer diagnostic procedures including, but not limited to: (a) Cyst aspiration; (b) Diagnostic ultrasound; (c) Incisional, excisional, or other breast biopsy; (d) Needle biopsy; and (e) Needle localization; (2) Breast cancer treatment procedures including, but not limited to: (a) Adjuvant hormonal therapy; (b) Adjuvant or sole chemotherapy; (c) Adjuvant or sole radiation therapy; (d) Lumpectomy with radiation; (e) Lymph node dissection; (f) Modified radical mastectomy; (g) Radical mastectomy; and (h) Simple mastectomy; (3) Contingent upon available funds, breast reconstruction procedures including, but not limited to: (a) Construction of breast mound; (b) Augmentation mammoplasty; (c) Reduction mammoplasty; and (d) Mastopexy; (4) Cervical cancer or precancerous cervical lesion diagnostic procedures including, but not limited to: (a) Colposcopically directed cervical or vaginal biopsy, or both; (b) Colposcopy; (c) Endocervical curettage; and (d) Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or has had cervical cancer documented; (5) Cervical cancer or precancerous cervical lesion treatment procedures including, but not limited to: (a) Conization; (b) Cryosurgery; (c) Dilation and curettage; (d) Electric loop resection; (e) Hysterectomy; and (f) Laser treatment; and (6) Follow-up to treatment for breast cancer, cervical cancer, or a precancerous cervical lesion including, but not limited to: (a) Follow-up office visits with the medical case manager; and (b) Medical and laboratory tests ordered by the medical case manager. D. Non-reimbursed medical procedures and services include but are not limited to: (1) A screening mammogram; (2) A Pap or human papilloma virus test; (3) An experimental treatment other than a Phase-III controlled clinical trial for breast or cervical cancer; (4) A procedure or service not related to the diagnosis and treatment of breast and cervical cancer; (5) Organ transplants; and (6) Nipple reconstruction or tattooing, or both. E. The participating physician is responsible for the following: (1) Medical liability for the medical procedure performed on a referred, eligible patient; (2) Accepting a referral of an eligible patient from a local health department, hospital, or other health care provider; (3) Performing a medical test needed by the eligible patient; (4) Charging the patient for a non-reimbursed medical procedure performed; (5) Submitting a bill for the reimbursed medical procedure performed or service provided on the designated Departmental form within 12 months of the date of service as follows: (a) If an eligible patient is uninsured or is insured, but the insurance does not provide coverage for the reimbursed medical procedure or service, the participating physician shall send to the Department the bill for the procedure or service, with a denial from the applicable insurance carrier, on the form designated by the Department; (b) If an eligible patient is covered by Medicare or other insurance, the participating physician shall bill: (i) Medicare or the other insurance for the procedure or service in accordance with Medicare or the other insurance billing specifications; and (ii) The Department for the outstanding deductible and patient contribution amount. (6) Maintaining reports of the results of the following diagnostic tests and sending to the Department upon request: (a) Sonogram or other breast cancer test which identifies an area as suspicious; (b) Breast biopsy in which cancer is present; and (c) Cervical biopsy which identifies a change associated with: (i) Cervical carcinoma in situ; (ii) Cervical intraepithelial neoplasia; (iii) Invasive cervical cancer; or (iv) The human papilloma virus; (7) Maintaining reports of the results of the following diagnostic tests and sending to the Department upon request: (a) Sonogram or other breast cancer test that is negative or shows a benign finding; (b) Breast biopsy in which cancer is not present; and (c) Cervical biopsy which is negative or shows a benign finding; (8) Maintaining and sending to the Department upon request, reports pertaining to the staging of the cancer; and (9) Maintaining and sending to the Department, upon request, the result of a treatment procedure. F. The participating physician may not bill the Department under this Program for: (1) Completion of a form; (2) A broken or missed appointment; (3) A professional service rendered by mail or telephone; or (4) A professional service provided to a patient enrolled in a Medical Assistance program other than those listed in Regulation .03C(4) of this chapter. G. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .04-1 Physician Assistant Services. *COMAR 10.14.02.04-1* A. To be considered a participating physician assistant in the Program, the provider shall: (1) Be licensed to practice as a physician assistant in Maryland or a jurisdiction bordering Maryland; (2) Have a current written executed delegation agreement with a licensed supervising physician who is licensed to practice medicine in Maryland or a jurisdiction bordering on Maryland, if required by that jurisdiction; (3) Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: (a) The current Medical Assistance approved rate in the State of an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or services; (b) The reimbursement rate approved by the insurer plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; (c) The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or (d) For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer, and the Medical Assistance approved rate in the State plus the payment of the deductible and patient contribution amount by the Department; (4) Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and (5) Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5), (6), (7)(a)—(e), and (8)—(10) of this chapter. B. An eligible health care provider may be a physician assistant. C. The reimbursed medical services include services related to breast and cervical cancer rendered to participants in accordance with: (1) The functions allowed under: (a) The Physician Assistant’s Practice Act; (b) COMAR 10.32.03; and (c) The physician assistant’s written delegation agreement with a physician; or (2) If out-of-State, the functions authorized in the state in which the services are provided. D. Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer. E. The participating physician assistant shall accept the responsibilities pursuant to Regulation .04E—G of this chapter. #### Regulation .04-2 Certified Nurse Midwife Services. *COMAR 10.14.02.04-2* A. To be considered a participating certified nurse midwife in the Program, the provider shall: (1) Be a certified nurse midwife in Maryland or a jurisdiction bordering on Maryland and hold all certifications as required by the Maryland Board of Nursing; (2) Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: (a) The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or service; (b) The reimbursement rate approved by the insurer plus the payment of the deductible by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; (c) The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or (d) For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer, and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department; (3) Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and (4) Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5), (6), (7)(a)—(e), and (8)—(10) of this chapter. B. If out-of-State, the provider shall meet the regulatory requirements of the state in which the services are provided. C. The reimbursed medical procedure includes but is not limited to: (1) Colposcopically directed cervical or vaginal biopsy or both: (2) Colposcopy; (3) Cyst aspiration; (4) Endocervical curettage; (5) Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or if cervical cancer has been documented; (6) Medically necessary services within the provider’s scope of practice as described in COMAR 10.27.05; or (7) If out-of-State, nurse midwife services authorized in the state in which the services are provided. D. Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer. E. The participating certified nurse midwife shall accept the responsibilities pursuant to Regulation .04E—G of this chapter. #### Regulation .05 Nurse Practitioner Services. *COMAR 10.14.02.05* A. To be considered a participating nurse practitioner in the Program, the provider shall: (1) Be a certified nurse practitioner in Maryland or a jurisdiction bordering Maryland; (2) Have a current written attestation with a physician who is licensed to practice medicine in Maryland or a jurisdiction bordering Maryland, if required by that jurisdiction; (3) Agree to accept, for each reimbursed medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: (a) The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or has insurance that does not provide coverage for a certain procedure or service; (b) The reimbursement rate approved by the insurer plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; (c) The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or (d) For an eligible patient who has insurance that provides coverage for a reimbursed procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department; (4) Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and (5) Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5)—(6), (7)(a)—(e), and (8)—(10) of this chapter. B. An eligible health care provider may be a certified nurse practitioner. C. The reimbursed medical procedure includes but is not limited to: (1) Colposcopically directed cervical or vaginal biopsy or both; (2) Colposcopy; (3) Cyst aspiration; (4) Endocervical curettage; and (5) Endometrial biopsy if the patient has taken Tamoxifen for the treatment of breast cancer or if cervical cancer has been documented. D. Non-reimbursed medical procedures and services include a procedure or service not related to the diagnosis and treatment of breast and cervical cancer. E. The participating nurse practitioner shall accept the responsibilities pursuant to Regulation .04E, F, and G of this chapter. #### Regulation .06 Nurse Anesthetist Services. *COMAR 10.14.02.06* A. To be considered a participating nurse anesthetist in the Program, the provider shall: (1) Be a certified nurse anesthetist in Maryland or a jurisdiction bordering Maryland; (2) Be currently collaborating with an anesthesiologist or other physician who is licensed to practice medicine in Maryland or a jurisdiction bordering Maryland in the manner prescribed by COMAR 10.27.06 or by the jurisdiction in which the service is provided; (3) Agree to accept, for each covered medical procedure performed or service provided, the following reimbursement including, if applicable, a medical management fee as described in Regulation .15 of this chapter: (a) The current Medical Assistance approved rate in the State for an eligible patient who is uninsured or who has insurance that does not provide coverage for a reimbursed procedure or service; (b) The reimbursement rate approved by the insurer plus the payment of the deductible and the patient contribution amount by the Department for an eligible patient who has insurance, other than Medicare, that provides coverage for a certain procedure or service; (c) The reimbursement rate approved by Medicare plus the payment of the deductible and patient contribution amount by the Department for an eligible patient who is covered by Medicare only; or (d) For an eligible patient who has insurance that provides reimbursement for a covered procedure or service that is less than the current Medical Assistance approved rate, the reimbursement rate approved by the insurer plus the difference between the reimbursement rate approved by the insurer and the Medical Assistance approved rate in the State plus the payment of the deductible by the Department; (4) Agree to abide by the provisions set forth in this section by signing and sending to the Department the designated Departmental form; and (5) Agree to the medical, financial, and reporting requirements of the Program pursuant to Regulation .04A(5),(6), (9), and (10) of this chapter. B. An eligible health care provider may be a certified nurse anesthetist. C. The reimbursed medical procedure is anesthesia required for the diagnosis and treatment of breast cancer or cervical cancer. D. Non-reimbursed medical procedures and services include an anesthesia procedure or service not related to the diagnosis and treatment of breast cancer and cervical cancer. E. The participating nurse anesthetist provider shall accept the responsibilities pursuant to Regulation .04E(1)—(5), F, and G of this chapter. #### Regulation .07 Physical Therapy Services. *COMAR 10.14.02.07* A. To be considered a participating physical therapist in the Program, the provider shall: (1) Be a physical therapist licensed to practice physical therapy in Maryland or a jurisdiction bordering Maryland; (2) Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; (3) Follow standard health and safety procedures to protect an eligible patient from potential hazards; (4) Agree to the medical and reporting requirements of the Program pursuant to Regulation .04A(5), (9), and (10) of this chapter; (5) Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation plus the amount paid by the eligible patient’s health insurer, if applicable; and (6) Agree not to bill an eligible patient an additional charge for the covered service. B. The Program shall reimburse a participating physical therapist for a medically necessary physical therapy service ordered in writing by a participating physician when the service is: (1) Provided by a physical therapist or by a physical therapist assistant under the direct supervision of a physical therapist; (2) Provided in a physical therapy office or the patient's home; (3) Considered one or more of the following: (a) Diagnostic; (b) Rehabilitative; or (c) Therapeutic; (4) Directly related to the written treatment order; (5) Of sufficient complexity and sophistication, or the condition of the patient is such that the service of a physical therapist is required; (6) Rendered pursuant to a written treatment order which: (a) Is signed and dated by the prescribing physician; (b) Specifies the following: (i) Body part to be treated; (ii) Type of modality or treatment to be rendered; (iii) Expected result of physical therapy treatment; and (iv) Frequency and duration of treatment; (c) Is kept on file by the physical therapist as a part of the permanent patient record subject to review by the Department or its designee; (d) Is not altered by the physical therapist unless medically indicated, whereby the physical therapist shall make a necessary change and sign the treatment order, advising the prescribing physician of the change and noting it in the patient record; (7) Recorded in the permanent record to include the following: (a) The treatment order; (b) The initial evaluation by the physical therapist; (c) Significant past history; (d) Pertinent diagnoses and prognoses; (e) Contraindications, if applicable; and (f) Progress notes, at least once every 2 weeks; (8) For a written treatment order for treatment exceeding 30 days and the participating physician: (a) Reviews and rewrites the order monthly; or (b) Initials and dates a copy of the original order monthly; and (9) For an initial physical therapy evaluation, on a one-time basis, per condition, when the requirements of this regulation are met. C. The Program does not reimburse for services: (1) Performed by a physical therapy assistant when not under the direct supervision of the physical therapist; (2) Performed by a physical therapy aide; or (3) Not directly related to the treatment of breast and cervical cancer. D. The participating physical therapist is responsible for the following: (1) Submitting to the Department, within 12 months of the date of service, a request for payment on the designated form; (2) Certifying on the invoice that the treatment order is on file and was in effect at the time that services were rendered; and (3) Specifying on the invoice the type of treatment provided. E. Reimbursement Principles. (1) The Department shall reimburse the participating physical therapist: (a) The current Medical Assistance approved rate in the State for a covered service performed in the provider’s office for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed procedure or service; (b) The outstanding deductible and patient contribution for a covered service performed in the provider’s office for an eligible patient who has Medicare or other insurance that provides reimbursement for a covered procedure or service; and (c) For covered services performed in the home of an eligible patient pursuant to Regulation .11F of this chapter. (2) The Department may not reimburse the participating physical therapist for: (a) Services rendered by mail or telephone; (b) Completion of a form or report; (c) A broken or missed appointment; or (d) A service which is provided at no charge to the general public. F. The participating physical therapist shall obtain recovery pursuant to Regulation .17 of this chapter. G. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .08 Pharmacy Services. *COMAR 10.14.02.08* A. To be considered a participating pharmacy in the Program, the provider shall: (1) Obtain a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; (2) Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; (3) Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation plus the amount paid by the eligible patient's health insurer, if applicable; (4) Agree not to bill an eligible patient for an additional charge for the reimbursed pharmacy services provided; and (5) Maintain adequate prescription and administrative records for a minimum of 5 years and, upon request, allow the Department access to the records. B. Reimbursed pharmacy services include but are not limited to the following: (1) A prescription, when ordered and signed by a prescriber for an eligible patient, within the limits established by the Program which includes: (a) A legend drug, including but not limited to the following drug classifications: (i) Analgesic; (ii) Antidepressant; (iii) Antiemetic; (iv) Anti-infective; (v) Antineoplastic agent; (vi) Benzodiazepine; (vii) Colony stimulating factor; (viii) Hormone; and (ix) Individual vitamin; and (b) An especially formulated enteral or parenteral nutritional preparation required for a patient with a documented pathologic condition, when treatment is medically necessary and life sustaining; (2) Hypodermic needle and syringe; (3) Over-the-counter iron preparation; (4) Durable medical equipment as specified in Regulation .10B of this chapter; and (5) A disposable medical supply as specified in Regulation .10B of this chapter. C. Non-reimbursed pharmacy services include but are not limited to: (1) An over-the-counter drug, excluding iron preparations; (2) A legend drug for which federal finance participation is prohibited pursuant to 42 CFR §441.25; (3) An experimental drug; and (4) A drug not directly related to the diagnosis and treatment of breast or cervical cancer or a complication of treatment for breast or cervical cancer. D. The participating pharmacy responsibilities are as follows: (1) Monitoring an eligible patient’s file for contraindications and toxicity; and (2) Submitting a bill on the designated Departmental form for the reimbursed: (a) Medication; (b) Durable medical equipment; and (c) Disposable medical supply. E. The Department shall reimburse the participating pharmacy: (1) Pursuant to COMAR 10.09.03.07A—G, H(1)—(3), and (5)—(6); and (2) For the deductible or patient contribution amount, or both. F. The participating pharmacy shall obtain recovery pursuant to COMAR 10.09.03.08. G. Periodic peer review may be performed by the Department or its designee. H. Except as provided in §I of this regulation, a drug manufacturer shall pay drug rebates to the Department for reimbursable pharmacy services in the same manner and amount that rebates are provided to the State for State-Only and Pharmacy Assistance recipients' purchases of drugs in accordance with §1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)) which is incorporated by reference. I. Limitations. (1) The Department shall provide notice to a drug manufacturer who fails to provide adequate rebates in accordance with this chapter indicating that the manufacturer shall pay the drug rebate unless: (a) The manufacturer submits a written request to the Secretary for a waiver of the rebate requirement; and (b) The Secretary grants a waiver under §I(2) of this regulation. (2) The Secretary shall grant a waiver to the requirement set forth in §H of this regulation only if the Secretary determines that the drug manufacturer has demonstrated that: (a) The drug is a single source drug or an innovator multiple source drug; (b) The Department has determined that the drug is essential to the health of the eligible patient; (c) The drug has been given a rating of I-A by the Food and Drug Administration; and (d) The physician has obtained the Department's authorization for use of the drug before prescribing the drug to the eligible patient. (3) No manufacturer or its designee may dispute or request repayment of any rebate paid under §H of this regulation more than 3 years after the date the rebate was paid. J. Except when a manufacturer has been granted a waiver to the rebate requirement under §I of this regulation, the Program may not pay for a drug under this chapter if the manufacturer has not provided a rebate to the Program in accordance with §H of this regulation. #### Regulation .09 Hospital Services. *COMAR 10.14.02.09* A. To be considered a participating hospital in the Program, the provider shall: (1) Be licensed as a hospital in Maryland or a jurisdiction bordering Maryland; (2) Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; (3) Agree to accept, as payment in full, the amount paid by the Program pursuant to §E of this regulation; (4) Agree not to bill an eligible patient for an additional charge for the reimbursed hospital services provided; and (5) Maintain adequate records for a minimum of 5 years and, upon request, allow the Department access to the records. B. The participating hospital shall receive reimbursement for the following services: (1) Medically necessary inpatient hospital service for the number of days, per admission, including preoperative days certified by the utilization control agent, which is: (a) Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment for breast cancer or cervical cancer; and (b) Described in the eligible patient's medical record in sufficient detail to support the invoices submitted for services; and (2) Medically necessary outpatient hospital service which is: (a) Necessary for the provision of diagnostic, curative, palliative, or rehabilitative treatment for breast cancer or cervical cancer; and (b) Described in the eligible patient's medical record in sufficient detail to support the invoices submitted for services. C. Limitations. The limitations on coverage of some hospital inpatient and outpatient services contained in COMAR 10.09.92.05 apply to this Program. D. Preauthorization Requirements. (1) The following surgical procedures require preauthorization when performed on a hospital inpatient basis unless the patient is already a hospital inpatient for another condition, or an unrelated procedure is being done simultaneously which itself requires surgical hospitalization. If an emergency necessitates performing any of the listed procedures on an inpatient basis, the provider shall request and obtain post-authorization before billing. The procedures are: (a) Biopsy; (b) Breast biopsy if a two-stage procedure is planned for a possible malignancy; (c) Colposcopy; (d) Cryotherapy alone; (e) Cryotherapy with biopsy or dilation and curettage, or both; (f) Dilation and curettage; (g) Excision of benign lesion; and (h) Hysteroscopy. (2) Authorization is required by the Program for all preoperative inpatient days. E. The participating hospital is responsible for: (1) Submitting a bill for the reimbursed services provided on the designated Departmental form as follows: (a) If an eligible patient is uninsured, or is insured but the insurance does not provide coverage for the reimbursed service, the participating hospital shall send the Department the bill for the service, with a denial from the patient’s insurance carrier, within 12 months of the date of discharge or outpatient service; or (b) If an eligible patient is covered by Medicare or other insurance, the participating hospital shall bill: (i) Medicare or the other insurance for the procedure or service; and (ii) The Department for the outstanding deductible and patient contribution amount; (2) Documenting the sum collected from the eligible patient's insurer as a patient collection; and (3) Submitting properly completed attachments with the bill as requested by the Department. F. Reimbursement Principles. (1) The Program shall reimburse for a room and board charge for the day of admission, and may not reimburse for a room and board charge for the day of discharge from the participating hospital. (2) The participating hospital may not collect a total payment, including the eligible patient's insurance and the Department's payment, which exceeds the provider's rate established by the Department or its designee. (3) A participating hospital may not bill the Program a charge exceeding that charged the general public for a similar service. (4) The Department may not reimburse the participating hospital for: (a) Completion of a form or report; (b) A broken or missed appointment; (c) A professional service rendered by mail or telephone; or (d) A service which is provided at no charge to the general public. (5) The Department may not make direct payment to an eligible patient. G. Reimbursement Rates. (1) A participating hospital located in Maryland shall be reimbursed by the Department: (a) Pursuant to COMAR 10.09.92.07A(2)—(4) and B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; (b) Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or (c) For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed service, the outstanding deductible and patient contribution amount required by the insurer. (2) A participating hospital located in a state bordering Maryland shall be reimbursed by the Department: (a) Pursuant to COMAR 10.09.92.07B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; (b) Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or (c) For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed services, the outstanding deductible and patient contribution amount required by the insurer. (3) A participating hospital located in the District of Columbia shall be reimbursed by the Department: (a) Pursuant to COMAR 10.09.92.08A and B for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; (b) Pursuant to COMAR 10.09.92.07A(8) and (9) for an eligible patient who is covered by Medicare; or (c) For an eligible patient who has insurance other than Medicare that provides coverage for the reimbursed services, the outstanding deductible, and patient contribution required by the insurer. H. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .10 Disposable Medical Supplies and Durable Medical Equipment. *COMAR 10.14.02.10* A. To be considered a participating medical supply company in the Program, the provider of disposable medical supplies and durable medical equipment shall: (1) To the extent required by law, be licensed and legally authorized to practice or deliver services in Maryland or a jurisdiction bordering Maryland; (2) Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; (3) Agree to accept, as payment in full, the amount paid by the Department pursuant to §F of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount; (4) Agree not to bill an eligible patient for an additional charge for the eligible disposable medical supplies and eligible durable medical equipment other than the patient contribution amount, excluding the deductible; and (5) Maintain adequate records for a minimum of 6 years and, upon request, allow the Department access to the records. B. The Department shall reimburse for the following: (1) Eligible disposable medical supplies, including but not limited to: (a) Central catheter for administration of intravenous solutions; (b) Administration set for intravenous medication; (c) Parenteral feeding equipment, as follows: (i) Administration set; (ii) Dravon clamp; (iii) Filter; and (iv) Injection cap; and (d) Enteral feeding equipment, as follows: (i) Adapter; (ii) Administration set; (iii) Feeding syringe; and (iv) Nasogastric tube; (2) Eligible durable medical equipment for purchase or rental, including but not limited to: (a) A delivery system comprised of a pump and pole assembly for an enteral or parenteral feeding; (b) An individually form-fitted arm support stocking for a recipient prescribed by the participating physician as medically necessary, not to exceed two stockings at one time or three stockings in a 12-month period for a non-institutionalized individual; (c) IV pole for use with parenteral administration of medication; (d) External ambulatory infusion pump with administrative equipment, when the usual and customary mode of therapy has been tried and shown to be unsuccessful or impractical; (e) Breast prosthesis, including surgical brassiere; and (f) A wig when the following conditions are met: (i) Hair loss is a direct result of the administration of chemotherapy or radiation for the treatment of breast or cervical cancer; (ii) The cost does not exceed $350; and (iii) The wig is prescribed by an oncologist. C. The Department may not reimburse for the following: (1) A disposable medical supply which is not directly related to the diagnosis and treatment of breast cancer or cervical cancer; and (2) Durable medical equipment as follows: (a) Head covering; and (b) An item not directly related to the diagnosis and treatment of breast cancer or cervical cancer. D. Preauthorization is required for the disposable medical supply and durable medical equipment pursuant to COMAR 10.09.12.06A—F and H. E. Reimbursement Procedures. The participating medical supply company: (1) Shall submit the request for payment for the reimbursed service on the form designated by the Department within 12 months of the date of service as follows: (a) If an eligible patient is uninsured, or is insured but the insurance does not provide coverage for the reimbursed service, the participating medical supply company shall send the Department the bill for the service, with a denial from the patient’s insurance carrier; or (b) If an eligible patient is covered by Medicare or other insurance, the participating medical supply company shall bill: (i) Medicare or the other insurance for the service; and (ii) The Department for the outstanding deductible, patient contribution amount, and if the insurer pays less than the current Medical Assistance approved rate for the service, the difference between the insurance reimbursement rate and the Medical Assistance approved rate in the State; (2) May not bill the Program a charge exceeding the usual and customary charge to the general public for a similar item; and (3) Shall bill the Program the usual and customary charge for the prosthetic device and an individually form-fitted arm support stocking including: (a) Fitting; (b) Dispensing; and (c) Follow-up care. F. Reimbursement Procedures. (1) The Department shall reimburse the participating medical supply company: (a) Pursuant to COMAR 10.09.12.07F—K for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursed service; (b) Pursuant to COMAR 10.09.12.07R and S for an eligible patient who is covered by Medicare; or (c) The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare, that provides coverage for the reimbursed service. (2) The Department may not reimburse for: (a) Completion of a form; (b) A broken or missed appointment; (c) A professional service rendered by mail or telephone; or (d) A service rendered to the general public at no charge. G. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .11 Home Health Services. *COMAR 10.14.02.11* A. To be considered a participating home health services provider in the Program, the provider of home health services shall: (1) Be a home health services provider licensed in Maryland or a jurisdiction bordering Maryland; (2) Agree to abide by the provisions set forth in this regulation and apply for participation in the Program by signing and sending to the Department the designated Departmental form; (3) Comply with COMAR 10.09.04.03A, B(2),(3), C(4), and D, if offering skilled nursing care; (4) Accept, as payment in full for covered services rendered, the amount paid by the Program pursuant to §D of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount, and agree not to bill an eligible patient an additional charge for the covered services; and (5) Maintain the patient care, medical supply, billing, and the patient contribution amount records for a minimum of 6 years and, upon request, allow the Department access to the records. B. The Program shall reimburse for a service listed in §C of this regulation when the service is: (1) Provided upon the written order of the participating physician and furnished under the current plan of treatment; (2) Rendered to an eligible patient who is certified by the participating physician as homebound; (3) Consistent with the current diagnosis and treatment of the patient condition; (4) In accordance with accepted standards of practice; (5) Required by the medical condition rather than the convenience or preference of the patient; (6) Considered under accepted standards of practice to be a specific and effective treatment for the condition; (7) Required on a part-time, intermittent basis; (8) Rendered in the home of the eligible patient by a participating home health services provider; (9) Adequately described in the signed and dated progress note; and (10) Directly related to the diagnosis and treatment of breast cancer or cervical cancer. C. The Program provides reimbursement for the following: (1) Skilled nursing care provided by a licensed nurse when the complexity of the service requires the judgment, knowledge, and skill of a licensed nurse; (2) Physical therapy, provided by a licensed physical therapist as specified in Regulation .07 of this chapter; (3) Occupational therapy provided by a licensed occupational therapist as specified in Regulation .14 of this chapter; (4) Medical supplies and equipment as specified in Regulation .10B of this chapter; and (5) Other supplies which are used during a reimbursed home health visit as part of the treatment ordered by the participating physician. D. The Program does not reimburse for services: (1) Not directly related to the treatment of breast and cervical cancer; and (2) Pursuant to COMAR 10.09.04.05A, B, D, G, N, and P; (3) Rendered by Home Health Aides; and (4) Rendered by social workers. E. The participating home health services provider is responsible for: (1) Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service, as follows: (a) If an eligible patient is uninsured or is insured, but the insurance does not provide coverage for a reimbursed service, the participating home health services provider shall send the Department the bill for the service; or (b) If an eligible patient is covered by Medicare or other insurance, the participating home health services provider shall bill: (i) Medicare or the other insurance for the procedure or service; and (ii) The Department for the outstanding deductible and patient contribution amount; and (2) Not billing the Department under this Program a charge in excess of that charged the general public for a similar service or for a service rendered at no charge to the general public. F. Reimbursement Rates. A non-hospital-based participating home health services provider located in Maryland, or a participating home health services provider located in a jurisdiction bordering Maryland shall be reimbursed by the Department: (1) Pursuant to COMAR 10.09.04.07D for an eligible patient who is uninsured or who has insurance that does not provide coverage for the reimbursement service; and (2) For the outstanding deductible and patient contribution amount, if applicable, for an eligible patient who is covered by Medicare or other insurance. G. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .12 Medical Laboratory Services. *COMAR 10.14.02.12* A. To be considered a participating medical laboratory in the Program, the provider shall: (1) Be in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to: (a) Requirements for Medicare certification; (b) Compliance with the requirements pursuant to COMAR 10.10.03.01 if operating in Maryland; and (c) Requirements for the Federal Clinical Laboratory Improvement Act of 1988, 42 U.S.C. §263a; (2) Agree to accept as payment in full for the reimbursed service, the amount paid by the Program as specified in §E of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount; (3) Agree not to bill an eligible patient for an additional charge for the medical laboratory services provided; (4) Abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; (5) Place no restriction on the eligible patient's right to select a provider; and (6) Maintain records adequate to substantiate the ordering, performance, and reporting of laboratory procedures performed or referred for a minimum of 6 years, and, upon request, allow the Department access to the records. B. A reimbursed service includes but is not limited to the following: (1) Preparation, analysis, and interpretation of a cervical biopsy, endometrial biopsy, vaginal biopsy, and breast biopsy; and (2) A laboratory procedure or service related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion. C. A non-reimbursed service includes but is not limited to the following: (1) A laboratory service not directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion; (2) A service for which there does not exist an order signed by a participating health care provider; (3) A procedure for which the laboratory has not been certified by Medicare; (4) A service not provided according to the laws and regulations of the jurisdiction in which the service is rendered; (5) A procedure that is investigational or experimental in nature; and (6) A service included and paid for by the Program as part of the total charge submitted by an inpatient facility or hospital outpatient department. D. Reimbursement Procedures. The participating medical laboratory is responsible for: (1) Submitting a bill for the reimbursed service provided on the form designated by the Department within 12 months of the date of service as follows: (a) If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating medical laboratory shall send the bill to the Department; or (b) If an eligible patient is covered by Medicare or other insurance, the participating medical laboratory shall bill: (i) Medicare or the other insurance for the service; and (ii) The Department for the outstanding deductible and patient contribution amount; and (2) Keeping in the records, for each invoice, a copy of the signed orders from a participating health care provider requesting the service. E. Payment Procedures. (1) The Department shall pay the participating medical laboratory for a reimbursed service: (a) Pursuant to COMAR 10.09.09.07E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service; or (b) Pursuant to COMAR 10.09.09.07F and G(1) and 100 percent of co-insurance for an approved procedure for an eligible patient who is covered by Medicare. (2) The Department may not reimburse for: (a) Completion of a form or report; (b) A broken or missed appointment; and (c) A service which is normally provided at no charge. F. The Program shall reimburse for claims pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .13 Freestanding Ambulatory Surgical Center Services. *COMAR 10.14.02.13* A. To be considered a participating freestanding ambulatory surgical center in the Program, the provider shall: (1) Be Medicare certified to provide ambulatory surgical services in Maryland or a jurisdiction bordering Maryland; (2) Comply with COMAR 10.09.42.02 and .03B; (3) Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated Departmental form; (4) Agree to accept, as payment in full for the reimbursed service, the amount paid by the Program as specified in §E of this regulation plus, if applicable, the amount paid by the eligible patient's health insurer and the patient contribution amount; (5) Agree not to bill an eligible patient, who is either uninsured or who is insured with Medicare only, for the reimbursed service; (6) Agree not to bill an eligible patient, who has insurance coverage other than Medicare only, for an additional charge for the reimbursed service other than the patient contribution amount; (7) Maintain adequate records for a minimum of 6 years and, upon request, allow the Department access to the records; and (8) Agree to the medical requirements of the Program pursuant to Regulation .04A(8)—(10) of this chapter. B. The Program shall reimburse a participating freestanding ambulatory surgical center for a service when the service: (1) Complies with COMAR 10.09.42.04; and (2) Is directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion including, but not limited to, the following: (a) Breast biopsy; (b) Conization; (c) Dilation and curettage; (d) Laser treatment; (e) Mastotomy; and (f) Simple or partial mastectomy excluding modified radical mastectomy and radical mastectomy. C. The Program does not reimburse for the following: (1) A service that is not directly related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion; and (2) A service or procedure pursuant to COMAR 10.09.42.05. D. A participating freestanding ambulatory surgical center shall: (1) Accept and perform the responsibilities pursuant to Regulation .04E(1)—(7) and (9) of this chapter; and (2) Submit a bill for the reimbursed service provided for an eligible patient on the form designated by the Department within 12 months of the date of service as follows: (a) If an eligible patient is uninsured or has insurance that does not provide coverage for the reimbursed service, the participating freestanding ambulatory surgical center shall send the bill to the Department; or (b) If an eligible patient is covered by Medicare or other insurance, the participating freestanding ambulatory surgical center shall bill: (i) Medicare or the other insurance the composite rate for the service or procedure performed; and (ii) The Department for the outstanding deductible and patient contribution amount. E. The Department shall pay the participating freestanding ambulatory surgical center for a reimbursed service: (1) Pursuant to COMAR 10.09.42.06A, B, D, and E for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed service; (2) Pursuant to COMAR 10.09.42.06F for an eligible patient who is covered by Medicare; or (3) The outstanding deductible and patient contribution amount required by the insurer for an eligible patient who has insurance, other than Medicare, that provides coverage for the reimbursed service. F. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .14 Occupational Therapy Services. *COMAR 10.14.02.14* A. To be considered a participating occupational therapist in the Program, the provider shall: (1) Be an occupational therapist licensed to practice occupational therapy in Maryland or a jurisdiction bordering Maryland; (2) Agree to abide by the provisions set forth in this regulation by signing and sending to the Department the designated departmental form; (3) Follow standard health and safety procedures to protect an eligible patient from potential hazards; (4) Agree to requirements of the Program set forth in Regulation .04A(5), (9), and (10) of this chapter; (5) Agree to accept as payment in full the amount paid by the Program under §E of this regulation, plus the amount paid by the eligible patient's health insurer, if applicable; and (6) Agree not to bill an eligible patient an additional charge for the service. B. The cost of an occupational therapist’s services are covered as set forth in COMAR 10.09.04.04B(4). C. The Program does not reimburse for services: (1) Performed by an occupational therapy assistant if not under the direct supervision of a licensed occupational therapist; (2) Performed by an occupational therapy aide; or (3) Not directly related to the treatment of breast or cervical cancer. D. The participating occupational therapist is responsible for the following: (1) Submitting to the Department, within 12 months of the date of service, a request for payment on the designated form; (2) Certifying on the invoice that a treatment order is on file and was in effect at the time services were rendered; and (3) Specifying on the invoice the type of treatment provided. E. Reimbursement Principles. (1) The Department shall reimburse the participating occupational therapist: (a) For a covered service performed in the provider’s office the amount of: (i) The current Medical Assistance approved rate for the State for an eligible patient who is uninsured or has insurance that does not provide coverage for the reimbursed procedure or service; or (ii) The outstanding deductible and patient contribution for an eligible patient who is covered by Medicare or other insurance; and (b) For covered services performed in the home of an eligible patient under Regulation .11F of this chapter. (2) The Department may not reimburse the participating occupational therapist for: (a) Services rendered by mail or telephone; (b) Completion of a form or report; (c) A broken or missed appointment; or (d) A service which is provided at no charge to the general public. F. The participating occupational therapist shall obtain recovery under Regulation .17 of this chapter. G. The Program shall reimburse for claims submitted pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .15 Medical Management Fee. *COMAR 10.14.02.15* A. A participating health care provider eligible to receive a medical management fee may be one of the following: (1) Anesthesiologist; (2) Certified nurse midwife; (3) Family practitioner; (4) Gynecologist; (5) Medical internist; (6) Medical oncologist; (7) Nurse anesthetist; (8) Nurse practitioner; (9) Pathologist; (10) Physician assistant; (11) Radiation oncologist; (12) Radiologist; (13) Surgeon; and (14) Participating health care provider who renders services pursuant to §B of this regulation. B. The Department shall reimburse a participating health care provider as outlined in §A of this regulation a medical management fee of $50 each time a reimbursed service: (1) Is in compliance with the medical guidelines pursuant to Regulation .04A(7)(a)—(f) of this chapter; (2) Involves a consult with an oncologist pursuant to Regulation .04A(7)(g) and (h) of this chapter; (3) Is in compliance with the medical care management guidelines pursuant to Regulation .04A(6) of this chapter; or (4) Is billed with the medical management fee for reporting and includes a copy of the relevant medical report including, but not limited to: (a) Radiology; (b) Biopsy; (c) Operative; or (d) Staging. C. The Program shall reimburse for claims pursuant to this regulation as set forth in Regulation .21 of this chapter. #### Regulation .16 Department, Local Health Department, Hospital, and Health Care Provider Responsibilities. *COMAR 10.14.02.16* A. The Department is responsible for the following: (1) Developing the necessary administrative forms needed for the Program including, but not limited to, a: (a) Standard application form to determine eligibility of patients; (b) Release of patient information form; and (c) Participating health care provider agreement form; (2) Distributing the administrative forms to the following: (a) Freestanding ambulatory surgical center; (b) Home health services provider; (c) Certified nurse midwife; (d) Hospital; (e) Occupational therapist; (f) Local health department; (g) Medical laboratory; (h) Medical supply company; (i) Nurse anesthetist; (j) Nurse practitioner; (k) Pharmacy; (l) Physical therapist; (m) Physician assistant; (n) Physician provider; and (o) Other appropriate health care providers; (3) Providing upon request a list of participating health care providers to local health department coordinators and health care providers for referral of eligible patients; (4) Updating the list of participating health care providers not less than once a year; (5) Reviewing and reimbursing a bill submitted by a participating physician for the reimbursed medical procedure and service using the payment guidelines specified in Regulations .04E(5) and .15 of this chapter; (6) Reviewing and reimbursing a bill submitted by a participating physician assistant using the payment guidelines specified in Regulations .04-1 and .15 of this chapter; (7) Reviewing and reimbursing a bill submitted by a participating certified nurse midwife using the payment guidelines specified in Regulations .04-2 and .15 of this chapter; (8) Reviewing and reimbursing a bill submitted by a participating nurse practitioner using the payment guidelines specified in Regulations .05 and .15 of this chapter; (9) Reviewing and reimbursing a bill submitted by a participating nurse anesthetist using the payment guidelines specified in Regulations .06 and .15 of this chapter; (10) Reviewing and reimbursing a bill submitted by a participating physical therapist using the payment guidelines specified in Regulation .07 of this chapter; (11) Developing a list of reimbursed medications and pharmacy services; (12) Updating the medication and pharmacy service list at least annually; (13) Developing and providing information to the pharmacy; (14) Reviewing and paying a bill submitted by a participating pharmacy for reimbursed medication, pharmacy service, durable medical equipment, and disposable medical supplies according to Regulation .08E of this chapter; (15) Reviewing and paying a disposable medical supply and durable medical equipment bill and the required deductible, if applicable, according to Regulation .10 of this chapter; (16) Receiving the application for an eligible patient from the local health department, hospital, or health care provider; (17) Developing and issuing to an eligible patient a letter identifying the patient as a participant in the Program; (18) Reviewing and reimbursing a bill submitted by a participating home health services provider using the payment guidelines specified in Regulation .11 of this chapter; (19) Reviewing and reimbursing a bill submitted by a participating medical laboratory using the payment guidelines specified in Regulation .12 of this chapter; (20) Reviewing and reimbursing a bill submitted by a participating freestanding ambulatory surgical center using the payment guidelines specified in Regulation .13 of this chapter; (21) Reviewing and reimbursing a bill submitted by an occupational therapist using the payment guidelines specified in Regulation .14 of this chapter; (22) Reviewing and reimbursing in accordance with Regulation .22 of this chapter a bill submitted by: (a) MHIP or an insurer under contract with MHIP; or (b) A participating health care provider; and (23) Ensuring compliance with the applicable regulations within this chapter by performing a periodic review of the records of a: (a) Hospital; and (b) Participating health care provider. B. The local health department, hospital, and a health care provider who refers a patient to the Program, are responsible for the following: (1) Identifying potentially eligible patients; (2) Assisting the applicant in completing the application form; (3) Collecting the completed application form; (4) Collecting verifying documentation from the applicant, including, but not limited to, proof of residency; (5) Determining eligibility of the applicant using the general, medical, health insurance, and financial criteria specified in Regulation .03 of this chapter; (6) Assisting an eligible patient in selecting a participating health care provider and assisting in scheduling an appointment with the participating health care provider for the reimbursed medical procedure or service; (7) Having an eligible patient sign a release of information form; (8) Providing an eligible patient with a copy of a temporary referral letter, identifying the patient as a participant in the Program, to be given to the participating health care provider until the card is issued to the eligible patient by the Department; (9) Sending the original application with verifying information to the Department; and (10) Evaluating patient progress through follow-up contact with the patient and the participating health care provider. C. If an additional diagnostic or treatment procedure is necessary, the local health department, hospital, or health care provider who determines patient eligibility and refers an eligible patient to the Program shall repeat the procedure as set forth in §B(6) of this regulation. D. The local health department, hospital, or other health care provider who determines patient eligibility and refers an eligible patient to the Program shall document in the patient’s medical record the result of the reimbursed diagnostic and treatment procedure performed. #### Regulation .17 Reimbursement. *COMAR 10.14.02.17* A. The Department shall reimburse a participating health care provider only for a medical service or procedure related to the diagnosis and treatment of breast cancer, cervical cancer, or a precancerous cervical lesion for an eligible patient. B. The Department shall reimburse a participating health care provider a medical management fee pursuant to Regulation .15 of this chapter. C. The participating health care provider shall reimburse the Department for an overpayment. D. Insurance or Other Coverage. (1) If the patient has insurance or other coverage, the participating health care provider shall first seek payment from that source. (2) The provider shall submit a copy of the insurance carrier’s notice or remittance advice with the invoice. (3) If the insurance carrier provides coverage for a reimbursable procedure or service, the Department shall pay the deductible and patient contribution amount. (4) If an insurance carrier rejects the claim or pays less than the amount of the allowed Medical Assistance Program rate, the provider may submit a claim to the Department. (5) The Department shall pay the difference between what was paid by the insurance carrier and the maximum allowable Medical Assistance Program rate. (6) If payment is made by both the Department and the insurance carrier or other source for the same service, the provider shall refund to the Department within 60 days of receipt the amount paid by the Department, or the Department may recoup those funds. E. The Department may not make a direct payment to the eligible patient. #### Regulation .18 Liability. *COMAR 10.14.02.18* Responsibility for liability for services provided, and for the availability of appropriate insurance coverage, rests with the participating health care provider. #### Regulation .19 Termination from the Program. *COMAR 10.14.02.19* A. If the Department determines that a participating health care provider has failed to comply with the applicable regulations of this chapter, the Department may terminate the written agreement with the provider by giving 30 days notice in writing to the participating health care provider. B. The participating health care provider may terminate the provider agreement with the Department by: (1) Giving 30 days notice in writing to the Department; and (2) Notifying eligible patients, for whom services have not been provided, of the provider's withdrawal from the Program. #### Regulation .20 Appeal Procedures. *COMAR 10.14.02.20* A. A provider filing an appeal of the Department’s decision to terminate the provider’s agreement with the Program shall do so according to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. B. A provider shall file an appeal within 30 days of receipt of written notice of termination. #### Regulation .21 Billing and Reimbursement Time Limitations. *COMAR 10.14.02.21* A. The Program may not reimburse claims received for payment more than 12 months after the date of service except as specified in §§B—D of this regulation. B. To obtain reimbursement from the Program, a health care provider that originally submits a claim to Medicare or another health insurer shall also submit the claim to the Program within a period whereby the Program receives the claim within the latter of: (1) 12 months after the date of service; or (2) 6 months from the Medicare or other health insurer remittance date as shown on the explanation of benefits. C. The Program shall pay a claim that is originally rejected for payment due to improper completion or incomplete information only if: (1) The health care provider properly completes and resubmits the claim to the Program; and (2) The Program receives the resubmitted claim within the latter of: (a) The original 12 month period from the date of service; or (b) 6 months after claim rejection. D. When the Program initially rejects a claim for payment in error, the Program shall pay the claim if the participating health care provider resubmits the claim and the resubmitted claim is received by the Program within the same period specified in §C of this regulation. #### Regulation .22 Maryland Health Insurance Plan Coverage. *COMAR 10.14.02.22* A. In lieu of providing direct reimbursement to participating health care providers, the Program may pay MHIP, if available, to provide health coverage for individuals enrolled in the Program who are also eligible for MHIP. B. The Program may pay MHIP, if available, for health coverage for eligible patients, including: (1) MHIP premiums; (2) Pre-existing condition buy-downs; and (3) Any MHIP fees. C. The Program may not pay any amount to MHIP, if available, for an eligible patient’s spouse, children, or other family members enrolled in MHIP. D. Fees Reimbursable to Participating Providers. (1) The Program may reimburse participating health care providers for a bill the provider submits to the Department for patient contribution amounts and deductibles for services directly related to the treatment of breast and cervical cancer for individuals enrolled in MHIP through the Program, if funding is available for the payment of patient contribution amounts and deductibles under this section. (2) The Program's decision regarding whether to pay for patient contribution amounts and deductibles shall be based solely on the availability of funding and may not be contingent upon any other factor. (3) If MHIP does not provide coverage for a service covered by this chapter, the Program shall reimburse the participating health care provider as otherwise provided by this chapter. (4) To obtain reimbursement, the participating health care provider shall submit to the Program: (a) The bill for the service on the form designated by the Department; and (b) A copy of the explanation of benefits or denial from MHIP. E. Payment to MHIP. (1) The Department shall submit timely payments to MHIP for premiums, pre-existing condition buy-downs, and any MHIP fees for individuals enrolled in MHIP through the Program. (2) The Department shall work with the designated MHIP staff to assure timely payments of MHIP invoices for individuals enrolled in MHIP through the Program to: (a) Preserve MHIP coverage; and (b) Resolve any existing issues related to the payment of MHIP premiums. #### Regulation .23 Funding Availability. *COMAR 10.14.02.23* Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland. ### Chapter 03 — Breast Cancer Treatment Methods **Authority:** Health-General Article, §20-113, Annotated Code of Maryland **Administrative History:** Effective date: November 14, 1988 (15:23 Md. R. 2658) **Administrative History:** Regulation .01B amended effective January 20, 1992 (19:1 Md. R. 31) **Administrative History:** Regulation .03 amended effective January 20, 1992 (19:1 Md. R. 31) **Administrative History:** Chapter recodified from COMAR 10.06.05 to COMAR 10.14.03 in July, 1993 #### Regulation .01 Definitions. *COMAR 10.14.03.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen. (3) “Treating physician” means an individual authorized under the Medical Practice Act to practice medicine in Maryland who, in Maryland, treats a patient for breast cancer. #### Regulation .02 Requirements for the Maryland Department of Health. *COMAR 10.14.03.02* A. The Department shall provide a standardized written summary in layman's language that: (1) Lists effective methods of treating breast cancer that may be medically practicable including all types of surgical treatment and radiological, hormonal, and chemotherapeutic treatment and combinations of these treatments; and (2) Describes the advantages, disadvantages, risks, and procedures associated with each method of treatment. B. The Department shall update the standardized written summary annually. C. The Department shall provide a statement indicating acknowledgement of receipt of the standardized written summary to be signed by the patient. D. The Department shall distribute copies of the standardized written summary and the acknowledgement of receipt statement to all hospitals, clinics, other facilities, and physicians' offices where treatment of breast cancer is performed. #### Regulation .03 Requirements of Treating Physicians. *COMAR 10.14.03.03* A. At any time before, but not more than 5 days after, a treating physician informs a patient of a diagnosis of breast cancer, and before treatment, the treating physician shall give the patient: (1) The standardized written summary provided by the Department; or (2) An equivalent summary including the requirements under Regulation .02A written in language that the patient understands. B. A treating physician may not undertake any of the treatments described in Regulation .02A(1) until a breast cancer patient has been given the written summary described in §A(1) and (2) of this regulation. C. A treating physician who provides a patient with the written summary required under these regulations shall have the patient sign a statement provided by the Department acknowledging receipt of the summary and shall have a copy of this signed acknowledgement placed in the patient's medical record which is used by the treating physician. D. The requirements under this regulation do not apply if the: (1) Treating physician certifies in writing in the patient's medical record that one of the treatments for breast cancer described in Regulation .02A(1) occurred within 5 days of the physician informing the patient of the diagnosis; and (2) Treatment within this period of time was necessary to save the life of the patient. E. These regulations should not be interpreted to require a waiting period between diagnosis and treatment. F. This regulation is supplemental and additional to any other requirements established by other laws upon a treating physician and may not be regarded as in derogation or substitution of any requirements now existing upon a treating physician, such as the need to obtain informed consent for treatment. ### Chapter 04 — Breast Cancer Program **Authority:** Health-General Article, §20-116, Annotated Code of Maryland **Administrative History:** Effective date: November 10, 2003 (30:22 Md. R. 1581) **Administrative History:** Regulation .04 amended effective March 16, 2015 (42:5 Md. R. 486) #### Regulation .01 Purpose and Scope. *COMAR 10.14.04.01* A. This chapter: (1) Establishes the requirements for participating medical providers; (2) Sets criteria for applicant eligibility; (3) Outlines services covered; and (4) Delineates the responsibilities of the Department and local health departments for breast cancer screening, diagnosis, and treatment services under the Breast Cancer Program created by Health-General Article, §20-116, Annotated Code of Maryland. B. This chapter operates in conjunction with the: (1) Breast and Cervical Cancer Program; and (2) Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program, as set forth in COMAR 10.14.02. C. This chapter addresses the purpose set forth in Health-General Article, §20-116, Annotated Code of Maryland, by providing the services funded under the Breast Cancer Program through the programs cited in §B of this regulation. #### Regulation .02 Definitions. *COMAR 10.14.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Annual gross income” means the total amount of income received by the applicant and, if applicable, the applicant's spouse, each year from all sources before taxes are withheld. (2) “Applicant” means an individual who has applied to receive services under this chapter. (3) “Biennial” means once every other year. (4) “Breast and Cervical Cancer Program” means the program that is: (a) Administered by: (i) A local health department; or (ii) A private entity that contracts with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program; (b) Established for the early detection of breast and cervical cancer; and (c) Funded by: (i) The federal Centers for Disease Control and Prevention; (ii) The Breast Cancer Program under Health-General Article, §20-116, Annotated Code of Maryland; or (iii) Both. (5) “Breast Cancer Program” means the program created by Health-General Article, §20-116, Annotated Code of Maryland, to provide: (a) At least biennial screening mammograms and clinical breast examinations to low-income, underinsured and low-income, uninsured women 40 years old through 49 years old; (b) Annual screening mammograms and clinical breast examinations to low-income, underinsured and low-income, uninsured women 50 years old or older; and (c) Diagnosis and treatment for individuals who are identified by the Breast Cancer Program as being in need. (6) “Clinical breast examination” means a physical examination of the breast performed by a health care professional for the purpose of detecting breast cancer. (7) “Contract” means the written agreement between a local health department and a health care provider for the provision of breast cancer services. (8) “Copayment” means the set amount of money that an individual who is enrolled in a health insurance plan is responsible for paying each time the individual receives a medical service after the deductible, if applicable, has been paid. (9) “Deductible” means a specific sum of money that an individual who is enrolled in a health insurance plan is required to pay before the individual's health insurance plan reimburses the individual or the individual's medical provider for covered medical services received. (10) “Department” means the Maryland Department of Health. (11) “Diagnosis” means a histopathologic finding of breast cancer in a biopsy specimen. (12) “Eligible individual” means an applicant who meets the requirements of Regulation .03 of this chapter. (13) “Enrollee” means an eligible individual who has been accepted into the Breast Cancer Program. (14) “Free-standing ambulatory surgical center” means a facility that: (a) Provides ambulatory surgical services; (b) Is physically separate from a hospital or hospital grounds; (c) Is certified by Medicare to provide ambulatory surgical services in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and (d) Complies with COMAR 10.09.42.02 and .03B. (15) “Home health services provider” means a public or private agency, organization, or part of an agency or organization licensed in Maryland or a jurisdiction bordering Maryland that: (a) Meets one of the following licensure requirements: (i) If the provider is a home health agency located in Maryland, the provider is licensed under Health-General Article, Title 19, Subtitle 4, Annotated Code of Maryland; (ii) If the provider is a home health agency located in a jurisdiction bordering Maryland, the provider is legally authorized to provide home health services under the laws of that jurisdiction; (iii) If the provider is part of a hospital or related institution located in Maryland, the provider is licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; or (iv) If the provider is an individual who has a contractual agreement with the Department to provide skilled nursing care to eligible individuals, the individual is a nurse who is licensed under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland, to practice registered nursing; (b) Provides nursing or physical therapy services in the home; and (c) Meets the requirements for participation in Medicare. (16) “Hospital” means an institution which is located: (a) In Maryland, that is: (i) Subject to the provisions of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (ii) Licensed pursuant to COMAR 10.07.01; or (b) In a jurisdiction bordering Maryland, that is licensed pursuant to applicable standards established by the jurisdiction in which the hospital is located. (17) “Local health department” means a governmental entity that provides public health services on behalf of a county in Maryland or Baltimore City. (18) “Mammogram” means an X-ray examination of the breast to detect breast cancer that uses equipment: (a) Specifically dedicated for mammography, including: (i) X-ray tubes; (ii) Filters; (iii) Compression devices; (iv) Screens; (v) Films; and (vi) Cassettes; and (b) That is designed to deliver an average radiation exposure of less than one rad mid-breast with two views for each breast. (19) “Medical Assistance” means the program that: (a) Provides comprehensive medical and other health-related care for eligible individuals; and (b) Is administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §1396. (20) “Medical laboratory” means a laboratory that: (a) Examines tissue specimens in connection with the diagnosis, treatment, or control of human disease or the assessment of human health or nutritional or medical conditions; and (b) Is in compliance with the applicable license requirements for a medical laboratory providing services for Maryland residents including, but not limited to the requirements: (i) For Medicare certification; (ii) Set forth in Health-General Article, Title 17, Annotated Code of Maryland; (iii) Set forth in COMAR 10.10.01 — 10.10.08; and (iv) Of the federal Clinical Laboratories Improvement Act, 42 U.S.C. §263a. (21) “Medical supply company” means a provider of disposable medical supplies or durable medical equipment that, to the extent required by law, is licensed and legally authorized to practice or deliver services in Maryland or in a jurisdiction bordering Maryland under the laws of that jurisdiction. (22) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395. (23) “Nurse anesthetist” means a registered nurse who is: (a) Certified as a nurse anesthetist in Maryland or a jurisdiction bordering Maryland under the laws of that jurisdiction; and (b) Currently collaborating with an anesthesiologist or other physician who is licensed to practice medicine: (i) In Maryland as prescribed by COMAR 10.27.06; or (ii) In a jurisdiction bordering Maryland under the laws of that jurisdiction. (24) “Nurse practitioner” means a registered nurse who is certified: (a) By the Maryland Board of Nursing to engage in the activities specified in COMAR 10.27.07; or (b) As a nurse practitioner in a jurisdiction bordering Maryland under the laws of that jurisdiction. (25) “Participating medical provider under the Breast and Cervical Cancer Program” means a health care provider who has entered into a written agreement with a local health department or the private entity that contracts with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program to provide breast cancer services to an enrollee. (26) “Participating medical provider under the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program” means any of the following: (a) A physician who meets the requirements of COMAR 10.14.02.04A; (b) A nurse practitioner who meets the requirements of COMAR 10.14.02.05A; (c) A nurse anesthetist who meets the requirements of COMAR 10.14.02.06A; (d) A physical therapist who meets the requirements of COMAR 10.14.02.07A; (e) A pharmacy that meets the requirements of COMAR 10.14.02.08A; (f) A hospital that meets the requirements of COMAR 10.14.02.09A; (g) A medical supply company that meets the requirements of COMAR 10.14.02.10A; (h) A home health service provider that meets the requirements of COMAR 10.14.02.11A; (i) A medical laboratory that meets the requirements of COMAR 10.14.02.12A; or (j) A free-standing ambulatory surgical center that meets the requirements of COMAR 10.14.02.13A. (27) “Pharmacy” means an establishment or institution that holds a permit to provide pharmacy services under Health Occupations Article, Title 12, Subtitle 4, Annotated Code of Maryland. (28) “Physical therapist” means an individual who is licensed or registered to practice physical therapy: (a) In Maryland under Health Occupations Article, Title 13, Subtitle 3, Annotated Code of Maryland; or (b) In a jurisdiction bordering Maryland under the laws of that jurisdiction. (29) “Physician” means an individual who is licensed to practice medicine: (a) In Maryland under Health Occupations Article, Title 14, Subtitle 3, Annotated Code of Maryland; or (b) In a jurisdiction bordering Maryland under the laws of that jurisdiction. (30) “Recipient of service” means an enrollee who has received a covered service under this chapter. (31) “Registered nurse” means an individual who is licensed to practice registered nursing: (a) In Maryland under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; or (b) In a jurisdiction bordering Maryland under the laws of that jurisdiction. (32) “Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program” means the program operated by the Department to pay for breast and cervical cancer diagnostic and treatment procedures for eligible women under COMAR 10.14.02. (33) “Resident” means an individual who is currently residing in Maryland. (34) “Screening” means a medical test to detect cancer. (35) “Surgical consult” means a consultation with a surgeon for advice on the recommended follow-up of the results of screening tests that are not considered normal. (36) “Treatment” means the medical management and care of a patient for breast cancer. (37) “Ultrasound” means a medical test in which high frequency sound waves are used to make an image of a specific area of the breast to determine if a breast lump is a fluid-filled cyst or a solid mass. #### Regulation .03 Overview of Funding and Delivery of Services. *COMAR 10.14.04.03* A. The Breast Cancer Program created by Health-General Article, §20-116, Annotated Code of Maryland, provides State funding for breast cancer screening, diagnosis, and treatment for eligible individuals under this chapter. B. Services funded under the Breast Cancer Program shall be delivered through two previously existing programs as follows: (1) Breast cancer screening and diagnostic services shall be provided to an enrollee through local health departments and private entities that contract with the Department to render services in Baltimore City and Calvert County under the Breast and Cervical Cancer Program; and (2) Breast cancer diagnostic and treatment services shall be provided to an enrollee through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program. C. An applicant is eligible for services under the Breast Cancer Program if the applicant meets the eligibility requirements of either Regulation .04 or .05 of this chapter. #### Regulation .04 Eligibility — Breast and Cervical Cancer Program. *COMAR 10.14.04.04* A. To be eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant shall: (1) Be a resident of Maryland; (2) Be 40 years old or older; (3) Meet the financial eligibility criteria specified in §B of this regulation; (4) Meet the health insurance criteria specified in §C of this regulation; and (5) Be determined to be eligible to receive covered services by a: (a) Local health department or an agency or organization designated by the local health department; or (b) Private entity that contracts with the Department to render services in Baltimore City or Calvert County. B. Financial Eligibility Criteria. (1) Financial eligibility under this chapter is based on annual gross income and family size. (2) To be financially eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant may not have an annual gross income that exceeds 250 percent of the most recent federal poverty guidelines updated annually in the Federal Register by the United States Department of Health and Human Services in accordance with 42 U.S.C. §9902(2). (3) For the purposes of determining family size under the federal poverty guidelines set forth at §B(2) of this regulation, the following individuals are family members of the applicant: (a) The applicant; (b) The applicant's spouse; (c) The applicant's financially dependent children; and (d) The applicant's financially dependent relatives. C. To be eligible to receive breast cancer services under this chapter through the Breast and Cervical Cancer Program, an applicant shall meet one of the following health insurance criteria: (1) The applicant is not currently covered by health insurance; or (2) The applicant is currently covered by health insurance that: (a) Does not provide reimbursement for a service covered under this chapter; or (b) Requires the applicant to pay a co-pay, co-insurance, or a deductible that has not been met for a service covered under this chapter. D. An applicant may not receive breast cancer services under this chapter through the Breast and Cervical Cancer Program if: (1) The applicant is enrolled in Medical Assistance; or (2) The applicant is enrolled in a health maintenance organization. #### Regulation .05 Eligibility — Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program. *COMAR 10.14.04.05* To be eligible to receive breast cancer services under this chapter through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program, an applicant shall meet the eligibility requirements specified in COMAR 10.14.02.03. #### Regulation .06 Covered Services. *COMAR 10.14.04.06* A. The following breast cancer services are covered for enrollees under this chapter through the Breast and Cervical Cancer Program: (1) Annual clinical breast examinations; (2) Mammograms that are provided: (a) Annually to enrollees 50 years old or older; and (b) At least on a biennial basis to enrollees 40 years old through 49 years old; and (3) Follow-up clinical breast examinations, mammograms, ultrasounds, and surgical consults as considered medically necessary by the participating medical provider under the Breast and Cervical Cancer Program. B. The following breast cancer services are covered for enrollees under this chapter through the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program: (1) A physician's services as described in COMAR 10.14.02.04C; (2) A nurse practitioner's services as described in COMAR 10.14.02.05C; (3) A nurse anesthetist's services as described in COMAR 10.14.02.06C; (4) A physical therapist's services as described in COMAR 10.14.02.07B; (5) A pharmacy's services as described in COMAR 10.14.02.08B; (6) A hospital's services as described in COMAR 10.14.02.09B; (7) A medical supply company's services as described in COMAR 10.14.02.10B; (8) A home health service provider's services as described in COMAR 10.14.02.11B; (9) A medical laboratory's services as described in COMAR 10.14.02.12B; or (10) A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13B. C. The following breast cancer services are not covered for enrollees under this chapter: (1) A physician's services as described in COMAR 10.14.02.04D; (2) A nurse practitioner's services as described in COMAR 10.14.02.05D; (3) A nurse anesthetist's services as described in COMAR 10.14.02.06D; (4) A physical therapist's services as described in COMAR 10.14.02.07C; (5) A pharmacy's services as described in COMAR 10.14.02.08C; (6) A hospital's services as described in COMAR 10.14.02.09C; (7) A medical supply company's services as described in COMAR 10.14.02.10C; (8) A home health service provider's services as described in COMAR 10.14.02.11D; (9) A medical laboratory's services as described in COMAR 10.14.02.12C; or (10) A free-standing ambulatory surgical center's services as described in COMAR 10.14.02.13C. #### Regulation .07 Responsibilities of the Department. *COMAR 10.14.04.07* The Department shall: A. Award grants to local health departments and private entities in Baltimore City and Calvert County as specified by Health-General Article, §20-116, Annotated Code of Maryland, for use in providing breast cancer screening services to eligible women under the Breast and Cervical Cancer Program; and B. Reimburse a participating medical provider under the Reimbursement for Breast and Cervical Cancer Diagnosis and Treatment Program for performing covered breast and cervical cancer diagnosis and treatment services on enrollees, pursuant to funding provided under Health-General Article, §20-116, Annotated Code of Maryland. #### Regulation .08 Responsibilities of Local Health Departments and Private Entities. *COMAR 10.14.04.08* A. A local health department and the private entities in Baltimore City and Calvert County shall: (1) Enter into written agreements with health care providers to provide breast cancer services to enrollees using the contracts developed by the Department for use in the Breast and Cervical Cancer Program; (2) Reimburse a participating medical provider under the Breast and Cervical Cancer Program for performing covered services on enrollees; (3) Determine eligibility of applicants using the criteria specified in Regulation .05 of this chapter; (4) Recruit eligible individuals; and (5) Provide enrollees, recipients of services, and medical providers with assistance in obtaining program-related information and services. B. In order to assure the availability of breast cancer diagnostic and treatment services, a local health department shall comply with COMAR 10.14.02.15B. #### Regulation .09 Funding Availability. *COMAR 10.14.04.09* The implementation and ongoing administration of this chapter is contingent upon the availability of funds. ### Chapter 05 — Maryland Cancer Fund **Authority:** Health-General Article, §20-117; Tax-General Article, §2-112; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .16 adopted as an emergency provision effective June 1, 2006 (33:15 Md. R. 1274); adopted permanently effective October 9, 2006 (33:20 Md. R. 1616) **Administrative History:** Regulation .02B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) **Administrative History:** Regulation .02B amended as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); amended permanently effective April 6, 2009 (36:7 Md. R. 524) **Administrative History:** Regulation .02B amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .02B amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .03A amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .05C amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) **Administrative History:** Regulation .07 amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) **Administrative History:** Regulation .08 amended effective October 4, 2010 (37:20 Md. R. 1393); March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .08 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .08D, E amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) **Administrative History:** Regulation .09 amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .10A amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .11 amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .12 amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .13 amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .14 amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .14C, D amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) **Administrative History:** Regulation .14D, E amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .15 amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .15B amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); amended permanently effective October 20, 2008 (35:21 Md. R. 1824) **Administrative History:** Regulation .16C amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulation .16C amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 88); amended permanently effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .16D amended effective October 4, 2010 (37:20 Md. R. 1393) #### Regulation .01 Purpose and Scope. *COMAR 10.14.05.01* This chapter: A. Defines the Maryland Cancer Fund; B. Describes how contributions may be made to the Maryland Cancer Fund; C. Sets forth the responsibilities of the Maryland Department of Health and the Comptroller with respect to the Maryland Cancer Fund; D. Identifies eligible applicants; and E. Outlines the grant application process for the Maryland Cancer Fund. #### Regulation .02 Definitions. *COMAR 10.14.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Annual family income” means the total amount received per year from all sources before taxes are withheld. (2) “Applicant” means a person who has applied to receive a grant under the Maryland Cancer Fund. (3) “Applied research” means research that is undertaken to determine: (a) Possible uses for the findings of basic research; or (b) New ways of achieving some specific objective. (4) “Authorized representative” means an individual or organization that has received permission from an individual diagnosed with cancer to perform certain tasks on the individual's behalf. (5) “Basic research” means experimental or theoretical work undertaken to acquire new knowledge or understanding of cancer. (6) “Case management” means the coordination of services by a health care professional for an individual for cancer: (a) Screening; (b) Diagnosis; or (c) Treatment. (7) “Capital expenditures” means money spent to add or expand property, equipment, and assets that will benefit an organization in the long term. (8) "Center for Cancer Prevention and Control (CCPC)" means a unit of the Maryland Department of Health within the Prevention and Health Promotion Administration. (9) “Clinical research” means research: (a) Conducted primarily on patients; and (b) Designed to answer questions about the etiology, prevention, early detection, diagnosis, or treatment of cancer. (10) “Community-based participatory research” means a collaborative, partnership approach to research that equitably involves community members, organizational representatives, and researchers in all aspects of the research process. (11) “Comptroller” means the Comptroller of the Treasury. (12) “Coinsurance” means the percent of allowable charges for a medical service that an individual with health insurance is responsible for paying. (13) “Copayment (copay)” means the set amount of money that an individual with health insurance is responsible for paying each time the individual receives a medical service. (14) “County” means a county of this State or Baltimore City. (15) “Current Procedure Terminology (CPT)” means the uniform descriptive terms and identifying codes for reporting medical services and procedures performed by physicians. (16) “Deductible” means the amount of money that an individual with health insurance is required to pay before the individual's health insurance starts coverage. (17) “Department” means the Maryland Department of Health. (18) “Diagnosis” means a histopathologic finding of cancer in a: (a) Biopsy; or (b) Surgical specimen. (19) Educational Institution. (a) “Educational institution” means an organization whose primary mission is to educate individuals. (b) “Educational institution” includes: (i) Private and public elementary schools; (ii) Middle schools; (iii) High schools; (iv) Colleges; (v) Universities; (vi) Graduate schools; and (vii) Research institutions. (20) “Family” means the unit comprised of all of the following that apply: (a) For a financially independent adult 18 years old or older diagnosed with cancer, the adult diagnosed with cancer or the adult diagnosed with cancer and one or more of the following: (i) Spouse; (ii) Financially dependent child; or (iii) Financially dependent relative; or (b) For a financially dependent child, the child and one or more of the following: (i) Parent, foster parent, or guardian; (ii) Sibling living in the household; or (iii) Half brother or half sister living in the household. (21) “Federal poverty level” means the poverty guidelines, as amended, which are updated periodically in the Federal Register by the U.S. Department of Health and Human Services and which are incorporated by reference by COMAR 10.11.03.01–1. (22) “Fund” means the Maryland Cancer Fund. (23) Grant. (a) “Grant” means financial assistance from the State to support an applicant's activities related to cancer: (i) Research; (ii) Primary prevention; (iii) Secondary prevention; and (iv) Treatment. (b) “Grant” does not mean a contract. (24) “Governmental entity” means a federal, State, or local governmental organization. (25) “Health Services Cost Review Commission (HSCRC)” means the independent organization within the Department that is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (26) “Hospital” means an institution that: (a) Operates within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and (b) Is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the jurisdiction in which the service is provided. (27) “Laboratory” means a licensed or certified facility operated for the examination of material derived from the human body for the purpose of obtaining information for the diagnosis, treatment, and management of a disease. (28) “Local health department” means a governmental entity in a county in Maryland that provides public health services. (29) “Major medical equipment” means equipment that: (a) Costs in excess of $500; and (b) Is used for the provision of medical or health services. (30) “Maryland Comprehensive Cancer Control Plan” means the most recent edition of the cancer plan developed by the Department. (31) “Maryland Health Insurance Plan (MHIP)” means a State-administered program that: (a) Is operated by a unit within the Maryland Insurance Administration under Insurance Article, Title 14, Subtitle 5, Annotated Code of Maryland; and (b) Provides health insurance coverage to medically uninsurable Maryland residents. (32) “Medical Assistance” means the program administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §§1396 — 1396v, which provides comprehensive medical and other health-related care for eligible categorically and medically needy persons. (33) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §§1395 — 1395hhh. (34) “Patient contribution amount” means the amount of money required by an individual’s health insurance policy to be paid by the individual for a given medical procedure or service received, excluding the deductible. (35) “Physician” means an individual who is licensed to practice medicine in the jurisdiction in which the service is provided. (36) “Premium” means the amount of money than an individual pays in regular installments to a health insurer for a health insurance policy. (37) Primary Prevention. (a) “Primary prevention” means activities to prevent or reduce the development of cancer. (b) “Primary prevention” includes interventions such as: (i) Tobacco use prevention and cessation; (ii) Protection from ultraviolet light; (iii) Proper nutrition and physical activity; and (iv) Reduction of exposure to environmental and occupational carcinogens. (38) Research. (a) “Research” means activities to develop or advance the understanding of cancer or the techniques or modalities effective in the prevention, cure, screening, diagnosis, or treatment of cancer. (b) “Research” includes basic, clinical, applied, translational, and community-based participatory research. (39) “Secondary prevention” means activities to detect and diagnose cancer in its early stages, when the chances of treatment and control are the greatest. (40) “Secretary” means the Secretary of Health. (41) “Translational research” means using or applying new discoveries to benefit patient care. (42) “Treatment” means the medical management and care of a patient that is provided for: (a) Obtaining a cancer diagnosis, determining the full extent of the cancer spread, or treating the cancer, including: (i) Surgery; (ii) Chemotherapy; (iii) Radiation therapy; (iv) Hormonal therapy; (v) Biopsy; (vi) Imaging procedures; (vii) Laboratory testing; (viii) Home health services; and (ix) Medical supplies or medical equipment; (b) Treating medical complications resulting from cancer screening or treatment; (c) Treating other co-morbid conditions in order to treat cancer; or (d) Providing palliative or end-of-life care. (43) “Uninsured” means that an individual: (a) Does not have any health insurance; or (b) Has health insurance that does not cover the cancer prevention, screening, diagnosis, or treatment services provided under the Fund. #### Regulation .03 Maryland Cancer Fund. *COMAR 10.14.05.03* A. The Maryland Cancer Fund is a nonlapsing, special fund created by Health-General Article, §20-117, Annotated Code of Maryland, for cancer research, prevention, and treatment, which is generated from: (1) Contributions from the income tax checkoff system under Tax-General Article, §2-112, Annotated Code of Maryland; and (2) Any other donations to the Fund. B. The Department may only expend funds: (1) In accordance with an appropriation approved by the General Assembly in the annual State budget; or (2) Through an approved budget amendment under State Finance and Procurement Article, §§7-209 and 7-210, Annotated Code of Maryland. C. The Department may only make grant awards under the Fund for cancer: (1) Research; (2) Primary prevention; (3) Secondary prevention; or (4) Treatment. D. Any unspent portions of the Fund shall remain in the Fund and may not revert to the General Fund of the State. E. Money expended from the Fund is supplemental to, and is not intended to take the place of, funding that would otherwise be appropriated to the Department for cancer: (1) Research; (2) Primary prevention; (3) Secondary prevention; or (4) Treatment. #### Regulation .04 Contributions to the Maryland Cancer Fund. *COMAR 10.14.05.04* An individual or each spouse in the case of a joint income tax return may contribute an amount to the Fund by: A. Deducting the amount of the contribution from any refund due under a tax return; or B. Adding the amount of the contribution to the income tax to be paid with a tax return. #### Regulation .05 Responsibilities of the Department. *COMAR 10.14.05.05* The Department: A. Shall administer the Fund; B. May not spend more than 5 percent of the proceeds received from the Comptroller for the Fund to promote further donations to the Fund; and C. Shall provide a grant in each fiscal year to persons to conduct one or more of the following cancer-related activities: (1) Research; (2) Primary prevention; (3) Secondary prevention; or (4) Treatment. #### Regulation .06 Responsibilities of the Comptroller. *COMAR 10.14.05.06* The Comptroller shall: A. Include in the individual income tax return form: (1) A checkoff designated as the Maryland Cancer Fund contribution; and (2) A description that the Fund may only be used for cancer: (a) Research; (b) Primary prevention; (c) Secondary prevention; or (d) Treatment; B. Collect the checkoff contributions and other donations and account to the Treasurer for the money collected; C. Distribute the amount necessary to administer the checkoff system to an administrative cost account; D. After the distribution under §C of this regulation, distribute the remainder of the money to the Fund; and E. Notify the Department annually of: (1) The gross amount of donations to the Fund through the income tax checkoff system; (2) The gross amount of other donations to the Fund; and (3) The costs of administration of the income tax checkoff system by the Comptroller. #### Regulation .07 Persons Eligible For Grants. *COMAR 10.14.05.07* A. Subject to any limitations imposed under §B of this regulation, the following persons are eligible to receive a grant from the Department for cancer research, primary prevention, secondary prevention, or treatment: (1) Physicians; (2) Hospitals; (3) Laboratories; (4) Educational institutions; (5) Local health departments; (6) Governmental entities; and (7) Another person or organization with expertise in cancer research, primary prevention, secondary prevention, or treatment. B. The Department may limit the persons eligible to receive a grant in §A of this regulation based on: (1) Availability of funds; and (2) The Department's ability to account for and monitor the grant funding. C. In order to be eligible to receive a grant, an applicant: (1) May be a nonprofit or for-profit entity; (2) Shall have an office located in Maryland; and (3) May only propose work that will serve or benefit one or more Maryland residents. #### Regulation .08 Allowable Uses of the Funds. *COMAR 10.14.05.08* A. A grantee that is funded to conduct cancer research by the Fund may use the grant funds: (1) For basic, clinical, translational, applied, or community-based participatory research; (2) To support: (a) The individuals engaged in the research; and (b) The individual's support staff; and (3) To purchase office supplies. B. A grantee that is funded to conduct cancer primary prevention or secondary prevention by the Fund may use the grant funds for: (1) Education; (2) Outreach; (3) Policy changes; (4) Provider interventions; (5) Clinical services; (6) Case management; (7) Quality assurance; (8) Data collection; or (9) Partnership development. C. If a grantee is funded to conduct cancer secondary prevention services, the Fund shall provide to the grantee reimbursement for a clinical service at a rate not higher than the rate that: (1) Medicare pays for the clinical service in the region; or (2) The HSCRC has approved for the clinical service, if the clinical service is provided by a HSCRC-regulated facility. D. If a grantee is funded to conduct cancer secondary prevention or treatment, the grantee shall only provide clinical services to individuals who: (1) Are Maryland residents; and (2) Have an annual family income that is not more than 250 percent of the federal poverty guidelines. E. If a grantee is funded to conduct cancer treatment, a grantee may use the grant funds: (1) For grants awarded before January 1, 2014 to provide MHIP reimbursement, to pay up to a maximum of $15,000 for direct costs per individual per year for the premium, deductible, coinsurance, and copay of the MHIP costs and for services not covered under MHIP; or (2) To pay up to a specified amount, as determined by the Department, for direct costs per individual per year for the: (a) Deductible and patient contribution amount for the reimbursed medical procedure or service for insured individuals; and (b) Medical procedure or service not covered under their health insurance policy for individuals who meet the eligibility criteria of §D of this regulation; or (3) To pay up to a maximum of $20,000 for direct costs per individual per year for the cancer treatment costs under the individual’s treatment plan: (a) Who meet the eligibility criteria in §D of this regulation; and (b) At a rate not to exceed the rate that Medical Assistance pays for clinical services or the rate that the HSCRC has approved for the clinical services, if treatment is provided by a HSCRC-regulated facility. F. If a grantee is funded to pay for cancer treatment: (1) Under §E(1) of this regulation, the grantee shall only pay or direct the Department to pay MHIP the following for services directly related to the treatment of cancer for the individual diagnosed with cancer: (a) Premiums; (b) Deductibles; (c) Coinsurance; and (d) Copays; (2) Under §E(2) of this regulation, the grantee shall only pay or direct the Department to pay the deductible and patient contribution amount for the reimbursed medical procedure or service that the individual is required to pay for the services directly related to the diagnosis and treatment of cancer; and (3) May not pay any amount for the individual’s spouse, children, or other family members’ health insurance costs. G. For the purpose of §F(1) and (2) of this regulation, the Department shall pay the health insurance costs out of the funds that are set aside for the grantee. H. In addition to the direct costs allowed under §E of this regulation, the Fund shall also pay a maximum of 7 percent of the indirect costs to local health department grantees or non-local health department grantees. #### Regulation .09 Unallowable Uses of Grant Funds. *COMAR 10.14.05.09* A grantee may not use grant funds from the Fund to pay for: A. Major medical equipment purchases; B. Renovations; C. Capital expenditures; or D. Cancer prevention or cancer treatment that would be provided by an individual's existing health insurance, including: (1) Medical Assistance; (2) Medicare; or (3) Private health insurance. #### Regulation .10 Grant Application. *COMAR 10.14.05.10* A. A person may obtain an application packet from the CCPC for a cancer: (1) Research grant; (2) Primary prevention grant; (3) Secondary prevention grant; or (4) Treatment grant. B. An applicant may: (1) Apply for one or more grants in any fiscal year; and (2) Combine multiple requests for cancer research, primary prevention, or secondary prevention grants within a single application, provided that the information required for separate grant applications is included in the combined application. #### Regulation .11 Application Process for Cancer Research Grants. *COMAR 10.14.05.11* An applicant for a cancer research grant shall: A. Submit a completed application to the CCPC by the due date listed in the application packet; and B. Include in the application packet the following information as specified in the Department’s application packet: (1) An executive summary stating: (a) How the grant funds will be used; (b) What institutions and other persons will be involved in the research; (c) Whether basic, clinical, applied, translational, or community-based research is being proposed; (d) Whether the proposed research is included in a recommendation of the Maryland Comprehensive Cancer Control Plan; and (e) How the grant money is expected to further the knowledge of cancer; (2) A statement of the need for the cancer research, including: (a) Previous literature in the area; and (b) Any work that the applicant has done in the research area; (3) A proposed cancer research plan describing: (a) How the grant funds will be used; (b) Who will be involved in the research; (c) What the anticipated results of the research with the grant funds will be; and (d) What goals, objectives, and activities will be pursued with the grant funds; (4) A brief professional resume or curriculum vitae of: (a) The principal investigator; and (b) Other key staff; (5) A description of how the proposed research will help to eliminate disparities between racial and ethnic minorities and the white population; (6) A list of the institutional review boards to which the research will be submitted for review and approval before the research is initiated, including the: (a) Department's Institutional Review Board; and (b) Applicant's relevant institutional review board; (7) A timeline showing the expected start date and completion date for each activity to be conducted under the grant, including application to and approval from the: (a) Department's Institutional Review Board; and (b) Applicant's relevant institutional review board; (8) An organizational chart showing where the work under the research grant is located within the applicant's organization; (9) A statement that the grant funds will not be used to supplant any existing funding for this cancer research and, if an applicant receives funding for a similar cancer research activity, a listing of the funding: (a) Source; (b) Amount; and (c) Period for the activity; (10) A line item budget for the cancer research grant; and (11) A written budget justification for each line item request. #### Regulation .12 Application Process for Cancer Primary Prevention Grants. *COMAR 10.14.05.12* An applicant for a cancer primary prevention grant shall: A. Submit a completed application to the CCPC by the due date listed in the application packet; and B. Include in the application packet the following information, as specified in the Department's application packet: (1) An executive summary describing: (a) How the grant funds will be used; (b) What persons will be involved in the grant activities; (c) What cancer primary prevention activities will be conducted; (d) Whether the primary prevention activities are included in a recommendation in the Maryland Comprehensive Cancer Control Plan; (e) What population groups will be served and in what jurisdiction groups will be served; (f) What types of services will be offered, including education and policy initiatives: (g) What the eligibility for services will be; and (h) What outcome is expected as a result of the funding; (2) A statement of the need for the cancer primary prevention intervention; (3) A description of previous literature in the area documenting the effectiveness of the cancer primary prevention intervention; (4) A proposed cancer primary prevention plan describing the: (a) Estimated number of persons to be served; (b) Goals, objectives, and activities to be conducted with the grant funds; (c) Evaluation measures for each activity; (d) How the grant funds will be used; (e) Who will be involved in the plan; and (f) What the expected results of the activity with the grant funds are; (5) A description of how the primary prevention plan will address the goal of eliminating disparities between racial and ethnic minorities and the white population; (6) A list of key staff to be involved in the project, including: (a) If existing staff will be used in the project, a description of the experience of the key staff in carrying out similar cancer primary prevention activities; or (b) If new staff will be hired for the grant, a job description of the staff that will be responsible for carrying out the project; (7) A description of the previous experience of the applicant's organization in implementing similar cancer primary prevention activities; (8) A timeline showing the expected start date and completion date for each activity to be conducted under the grant; (9) An organizational chart showing: (a) Where the activities under the cancer primary prevention grant falls within the applicant's organizational structure; and (b) The relationship of the applicant with other organizations involved in the project; (10) A statement that the grant funds will not be used to supplant any existing funding for this cancer primary prevention activity and, if an applicant receives funding for a similar cancer primary prevention activity a list of the funding: (a) Source; (b) Amount; and (c) Period for the activity; (11) A line item budget for the cancer primary prevention grant; and (12) A written budget justification for each line item requested. #### Regulation .13 Application Process for Cancer Secondary Prevention Grants. *COMAR 10.14.05.13* An applicant for a cancer secondary prevention grant shall: A. Submit a completed application to the CCPC by the due date stated in the application packet; and B. Include in the application packet the following information, as specified in the Department's application packet: (1) An executive summary describing: (a) How the grant funds will be used; (b) What persons will be involved in the application; (c) What cancer secondary prevention activities will be conducted; (d) Whether the proposed activities are included in a recommendation in the Maryland Comprehensive Cancer Control Plan; (e) What population groups will be served and in what jurisdiction groups will be served; (f) What services will be offered, such as: (i) Outreach; (ii) Screening; (iii) Case management; (iv) Quality assurance; (v) Data collection; and (vi) Partnership building; (g) What the eligibility for services will be; and (h) What outcome is expected as a result of the grant funds; (2) A description of previous literature in the area documenting the effectiveness of the cancer secondary prevention activity; (3) A description and justification of the need for the cancer secondary prevention activity in the population group to be served; (4) A description of the population to be served including, at a minimum, a description of the following for the individuals to be served: (a) Age; (b) Race; (c) Gender; (d) Residency; (e) Educational level; (f) Income level; and (g) Health insurance requirements of persons to be served; (5) A description of the screening guidelines to be used for clinical services and the eligibility guidelines for these services, including age, symptoms, and, if appropriate, risk factors; (6) A description of the reimbursement levels to be used for clinical services provided with grant funds; (7) A proposed cancer secondary prevention plan describing: (a) The estimated number of individuals to be served; (b) The goals, objectives, and activities to be conducted with the grant funds; (c) Evaluation measures for each activity; (d) Who will be involved in the plan; and (e) What the expected results of the funded activity are; (8) A description of how the proposed cancer secondary prevention activities will address the goal of eliminating disparities between racial and ethnic minorities and the white population; (9) A list of key staff to be involved in the project, including: (a) If existing staff will be used in the project, a description of the experience of the key staff in carrying out similar cancer secondary prevention activities; or (b) If new staff will be hired for this activity, a job description of the staff responsible for carrying out the project; (10) A description of the previous experience of the applicant's organization in implementing similar cancer secondary prevention activities; (11) A timeline showing the expected start date and completion date for each activity to be conducted with the grant funds; (12) An organizational chart showing: (a) Where the cancer secondary prevention grant activities fall within the applicant's organizational structure; and (b) The relationship of the applicant with other organizations involved in the project; (13) A statement that the grant funds will not be used to supplant any existing funding for this cancer secondary prevention activity and, if an applicant receives funding for a similar cancer secondary prevention activity, a list of the funding: (a) Source; (b) Amount; and (c) Period for the activity; (14) A line item budget for the cancer secondary prevention grant; and (15) A written budget justification for each line item requested. #### Regulation .14 Application Process for Cancer Treatment Grants. *COMAR 10.14.05.14* A. An applicant for a cancer treatment grant shall submit a completed application to the CCPC. B. Cancer treatment grants are open and continuous throughout the year to the extent that funding is available. C. An applicant seeking a cancer treatment grant to pay for cancer treatment costs shall include in the Department's application packet: (1) A completed cancer treatment grant application for each individual for whom grant funds are being requested, including the: (a) Name; (b) Phone number; (c) Mailing address; (d) County; and (e) Signature of the: (i) Individual diagnosed with cancer if the individual is an adult; or (ii) Parent or guardian if the individual diagnosed with cancer is younger than 18 years old; (2) A letter written by the individual’s physician on the physician’s letterhead: (a) Confirming: (i) That the individual has been diagnosed with or treated for cancer or the individual has a finding suggestive of cancer and needs to obtain a cancer diagnosis; and (ii) The dates of diagnosis or treatment; and (b) Containing the physician's: (i) Full name; (ii) Address; (iii) Specialty; and (iv) Medical license number; (3) Proof of current Maryland residency for at least 6 months before the application date for each individual for whom grant funds are being requested in one of the following forms: (a) Maryland driver’s license or State identification card; (b) Lease or rental agreement; (c) Property tax bill; (d) Motor vehicle registration; (e) Pay check or stub with name and home address; (f) Utility bill; (g) Voter registration card; or (h) W-2 statement issued not more than 12 months ago; (4) Proof of annual family income for each individual for whom grant funds are being requested, including a copy of at least one of the following: (a) Most recent: (i) Income tax return; or (ii) W-2 form; (b) Pay stubs for two: (i) Consecutive pays; or (ii) Pays in the same month; (c) Social security entitlement letter; or (d) Notarized letter from the individual stating that the individual is not working and does not have any income; (5) Documentation of the eligibility of the individual for grant funds, including: (a) The family size of the individual for whom the applicant is applying; and (b) The family’s annual household income; (6) Certification that the applicant will: (a) Keep financial records, as described in Regulation .16B of this chapter; (b) Send demographic and fiscal information on each individual covered to the CCPC at the end of the grant period; and (c) Act as the authorized representative of the individual. (7) Attestation that grant funds will not be used to supplant any existing funding for this cancer treatment activity; and (8) If the applicant currently receives funding for a similar cancer treatment activity, a list of the funding: (a) Source; (b) Amount; and (c) Period for the activity. D. An applicant seeking a cancer treatment grant to pay for deductibles and patient contribution costs through their health insurance policy under Regulation .08E(2) of this chapter shall include in the Department’s application packet: (1) A completed and signed Maryland Cancer Fund — Cancer Treatment Grant application that; (a) Certifies that the applicant shall pay: (i) The deductible and patient contribution amount; and (ii) Costs for services not covered under the individual’s health insurance policy for a time period not to exceed 1 year; and (b) Includes a treatment plan for a total request not to exceed a specified amount, as determined by the Department, per individual per year, including the: (i) Deductible and patient contribution amount; and (ii) Costs for services not covered under the individual’s health insurance policy. (2) Documentation of the individual’s health insurance policy. E. An applicant seeking a cancer treatment grant to pay directly for cancer treatment costs under Regulation .08E(3) of this chapter shall include in the Department’s application packet: (1) A completed Maryland Cancer Fund — Cancer Treatment Grant application; and (2) A signed document that certifies that the applicant shall pay directly for cancer treatment costs for the individual for a time period not to exceed 1 year; and certifies that the applicant shall: (a) Reimburse the provider in an amount not greater than the Medical Assistance rate for the medical procedure or the HSCRC-regulated rate for the medical procedure performed, if the medical procedure is performed in a HSCRC-regulated facility; or (b) Accept the Medical Assistance rate as payment in full for the cancer treatment procedures performed, if the applicant is a medical provider; and (3) Includes a treatment plan for a total request not to exceed $20,000 per individual, including: (a) The planned cancer treatment procedures; and (b) The Medical Assistance or HSCRC-regulated rate for each procedure. #### Regulation .15 Grant Application Review and Approval and Grant Extensions. *COMAR 10.14.05.15* A. Each fiscal year the CCPC shall determine: (1) The amount of money available for grants under the Maryland Cancer Fund; (2) The allocation of funding for cancer: (i) Research; (ii) Primary prevention; (iii) Secondary prevention; and (iv) Treatment; and (3) The maximum grant award amount for each type of grant. B. Each year the Department shall consider for award, funding for one or more of the following types of grant applications for cancer: (1) Research; (2) Primary prevention; (3) Secondary prevention; and (4) Treatment. C. The CCPC shall develop one or more evaluation committees or shall contract with one or more external consultants with expertise in cancer research and prevention to review the cancer research and primary prevention and secondary prevention grant applications that are submitted for funding under the Maryland Cancer Fund. D. Due to the need for timeliness in the cancer treatment grants, the CCPC shall review each application for cancer treatment. E. The evaluation committee or external consultants shall review: (1) Cancer research grant applications based on: (a) Scientific need; (b) The degree to which the cancer research plan will achieve the goals and objectives set forth in the plan; (c) The inclusion of a plan for Institutional Review Board approval; (d) The feasibility of the timeline in delivering goals and objectives of the plan; (e) The experience and expertise of the principal investigator; (f) The degree to which a grant application addresses eliminating disparities between racial and ethnic minorities and the white population; (g) Whether the research is recommended in the Maryland Comprehensive Cancer Plan; (h) The lack of other resources or funding for the proposed research; and (i) The amount of the funding requested; (2) Cancer primary prevention grant applications based on: (a) The need for the cancer primary prevention activity; (b) The previously documented effectiveness of the primary prevention intervention; (c) The degree to which the cancer primary prevention plan will achieve the goals and objectives set forth in the plan; (d) The degree to which a grant application addresses eliminating disparities between racial and ethnic minorities and the white population; (e) The experience of the applicant in cancer primary prevention; (f) Whether the primary prevention intervention is recommended in the Maryland Comprehensive Cancer Control Plan; (g) The lack of other resources or funding for the proposal; and (h) The amount of funding requested; and (3) Cancer secondary prevention grant applications based on: (a) The previously documented effectiveness of the secondary prevention intervention; (b) The need for the cancer secondary prevention intervention in the population group to be served; (c) The degree to which the cancer secondary prevention plan will achieve the goals and objectives of the plan; (d) The feasibility of the timeline in delivering the goals and objectives of the plan; (e) The extent to which medical guidelines for screening and diagnosis are being followed; (f) The percent of the budget allocated to clinical services; (g) The degree to which the grant application addresses eliminating disparities between racial and ethnic minorities and the white population; (h) The experience of the applicant in cancer secondary prevention; (i) Whether the secondary prevention intervention is recommended in the Maryland Comprehensive Cancer Control Plan; (j) The lack of other resources or funding for the proposal; and (k) The amount requested. F. After reviewing each cancer research, primary prevention, and secondary prevention grant application, the evaluation committee or external consultant shall make a recommendation to the CCPC about whether to award grant funds to each applicant. G. The CCPC shall review each cancer treatment application based on: (1) Completeness; (2) Availability of funds; and (3) Whether the application meets the relevant application process requirements set forth in this chapter. H. The Director of the CCPC shall recommend an application to the Secretary for approval based upon: (1) The evaluation committee's or external consultant's recommendations for awarding the cancer research, primary prevention, secondary prevention, and treatment grants for each application; and (2) The availability of funds. I. The Secretary shall: (1) Consider the grant recommendations of the CCPC for the cancer: (a) Research; (b) Primary prevention; (c) Secondary prevention; and (d) Treatment; and (2) Make the final determination on which grant applications to approve. J. A grant period expires 1 year from the date of award of the grant, unless extended as set forth in Regulation .16 of this chapter. K. A person awarded a grant under this chapter may apply for a no-cost extension of the grant period for the award before the expiration of the grant period, as set forth in §J of this regulation, by submitting a written request for an extension to the CCPC. L. In evaluating whether to grant an extension of the grant period, the CCPC: (1) Shall assess whether progress has been made on the grant; and (2) If progress has been made based on the reports submitted pursuant to Regulation .16C of this chapter, may recommend to the Secretary that an extension be granted. M. The Secretary may approve an extension for up to 1 year based on: (1) The recommendation of the CCPC; and (2) Whether progress has been shown on the grant pursuant to Regulation .16C of this chapter. #### Regulation .16 Payments, Terms and Conditions of Grant Awards, and Terminations. *COMAR 10.14.05.16* A. Payments Under the Grant. (1) The Department may not make more than monthly payments during the grant period to a person awarded a grant under this chapter. (2) Before the first payment under the grant, at the request of the person awarded the grant under this chapter, the Department may approve an advanced payment for the grant based on financial need, if a request for advanced payment was specified in the grant application. (3) If a financial or progress report required in §B or C of this regulation is overdue, the Department may withhold payment until the report is submitted. B. Financial Reports and Records. (1) A person awarded a grant shall: (a) Establish a separate account to track expenditures under the grant; (b) Maintain accurate records, including documentation of each transaction pertaining to the grant; and (c) Submit to the Department monthly invoices for payment and an annual financial expenditure report containing the signature of the financial officer of the entity affiliated with the grant award. (2) The Department may audit the accounts referenced in §B(1) of this regulation at any time. (3) A person awarded a grant under this chapter shall submit to the Department within 90 days after the date the grant period ends: (a) A final financial expenditure report; and (b) A refund of any unexpended funds. (4) A person awarded a grant under this chapter shall retain all records pertaining to a grant award for 3 years from the date the final financial expenditure report is submitted under §B(3) of this regulation. (5) In the case of an audit or litigation, the Department may extend the time period under §B(3) or (4) of this regulation until the completion of the audit or litigation. C. Progress Reports. (1) A grantee shall submit to the CCPC three copies of: (a) An interim report describing the progress of the grant: (i) 6 months after the date of award of the grant; and (ii) Every 6 months until the end of the grant; and (b) A comprehensive final report, not later than 60 days after the date the grant period ends, that provides a summary of all of the activity conducted under the grant. (2) A grantee receiving a cancer research grant shall include the following information in the comprehensive final report: (a) Hypothesis; (b) Methods; (c) Results; (d) Discussion of results and limitations of the research; and (e) Conclusion. (3) A grantee receiving a cancer primary prevention or secondary prevention grant shall include the following information in the comprehensive final report: (a) Number of individuals served, by: (i) Type of service; (ii) Age; (iii) Race; and (iv) Gender; (b) Number of individuals with abnormal screening results, by type of cancer; (c) Number of cancers diagnosed; and (d) Other outcome measures. (4) A grantee receiving a cancer treatment grant shall include the following information in the comprehensive final report for each individual receiving funds for cancer treatment: (a) Type of cancer; (b) Stage of cancer at diagnosis; (c) Age; (d) Race; (e) Gender; (f) County; and (g) Amount of funds expended. (5) The Department shall keep research results confidential as required by Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland. D. Publications. (1) A person who publishes results from activities supported by a grant approved by the Secretary under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Maryland Cancer Fund of the Maryland Department of Health.” (2) A person awarded a grant under this chapter shall provide the Department with three copies of any published article pertaining to the activities conducted under the grant. E. Ownership of Equipment. A person awarded a grant under this chapter: (1) Shall ensure that equipment purchased under a grant under this chapter is used for the sole purpose of the grant; (2) Shall keep an inventory of all equipment purchased; and (3) May not transfer the equipment to another entity without the written permission of the Department. F. Termination. (1) The Secretary may terminate a grant: (a) If a grantee fails to comply with: (i) The requirements of this chapter; or (ii) State, federal, and municipal laws applicable to the performance of research under the grant; (b) If a grantee fails to carry out the purposes for which the grant was awarded; (c) In compliance with a court order; or (d) At the request of the grantee. (2) The Department and the State are not responsible for any expenses incurred by a grantee after cancellation of a grant. (3) The grantee shall return all unexpended funds to the Department within 60 days of termination of a grant. G. Compliance with Existing Laws. A person awarded a grant under this chapter shall ensure that an activity conducted in the performance of the grant is in compliance with all State, federal, and local laws. H. Liability. (1) A person awarded a grant under this chapter is solely responsible for the person's actions pertaining to research conducted under a grant award. (2) The State and the Department are not liable for any claims, losses, liabilities, expenses, or damages arising from research conducted under a grant awarded under this chapter. I. Grant Agreements. A person awarded a grant under this chapter shall enter into a grant agreement with the Department. ### Chapter 06 — Cigarette Restitution Fund Program **Authority:** Health-General Article, §§13-1001—13-1014 and 13-1101—13-1119, Annotated Code of Maryland **Administrative History:** Effective date: January 15, 2007 (34:1 Md. R. 32) **Administrative History:** Regulation .01 amended effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254); March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .03 amended effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .03A amended effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .04B amended effective February 27, 2017 (44:4 Md. R. 254); March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .05 repealed and new Regulation .05 adopted effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .06 repealed and new Regulation .06 adopted effective February 27, 2017 (44:4 Md. R. 254) #### Regulation .01 Scope. *COMAR 10.14.06.01* This chapter establishes the financial eligibility criteria for an uninsured or underinsured individual to receive cancer treatment services and tobacco treatment products under the Cigarette Restitution Fund Program. #### Regulation .02 Definitions. *COMAR 10.14.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual who has applied to receive cancer treatment services or tobacco treatment products under this chapter. (2) “Cancer Prevention, Education, Screening, and Treatment Program” means the program created by Health-General Article, §§13-1101—13-1119, Annotated Code of Maryland, to provide cancer prevention, education, screening, and treatment services in Maryland. (3) “Cancer treatment service” means a medical service, medical supply, or medical equipment provided to: (a) Treat cancer, including: (i) Surgery; (ii) Chemotherapy; (iii) Radiation therapy; (iv) Hormonal therapy; (v) Home health services; and (vi) Medical supplies and medical equipment; (b) Treat medical complications resulting from cancer screening or treatment; (c) Treat other comorbid conditions in order to treat cancer; and (d) Serve the needs of cancer patients for palliative or end-of-life care. (4) “Department” means the Maryland Department of Health. (5) “Federal poverty level” means the amount of household income by family size that a family needs for basic necessities as determined by the federal poverty guidelines, as amended, which are updated annually in the Federal Register by the U.S. Department of Health and Human Services. (6) “Gross annual household income” means the total income of the applicant and any member of the applicant’s household received each year from all sources before taxes are withheld or deductions are taken. (7) “Local health department” means a governmental entity in a county in Maryland that provides public health services. (8) “Maryland Children’s Health Insurance Program” means the program administered by Medical Assistance to provide health insurance coverage to eligible children younger than 19 years old in Maryland. (9) “Medical Assistance” means the program that: (a) Provides comprehensive medical and other health-related care for eligible individuals; and (b) Is administered by the State under Title XIX of the Social Security Act, 42 U.S.C. §§1396—1396v. (10) “Medicare” means the medical insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (11) “Statewide academic health center” means: (a) The University of Maryland Medical Group; (b) The Johns Hopkins Institutions; (c) The organization designated by the Department as stipulated by Health-General Article, §13-1115, Annotated Code of Maryland; or (d) One or more of the organizations in §B(11)(a)—(c) of this regulation. (12) “Tobacco product” means cigarettes, cigars, pipe tobacco, smokeless tobacco, and any other product containing tobacco in any form. (13) “Tobacco treatment product” means all Food and Drug Administration-approved tobacco cessation medications, including both prescription and over-the-counter medications, that assist individuals to stop using tobacco products. (14) “Tobacco Use Prevention and Cessation Program” means the program created by Health-General Article, §§13-1001—13-1014, Annotated Code of Maryland, to provide tobacco use prevention and cessation services in Maryland. (15) “Underinsured” individual means an applicant: (a) Who has private medical insurance, Medical Assistance, Medicare, or Maryland Children’s Health Insurance Program coverage; (b) For whom the appropriate treatment is not adequately covered due to out-of-pocket costs including: (i) Copayments; (ii) Coinsurance; or (iii) Deductibles; and (c) Who the Department determines does not have the financial means to pay for appropriate treatment. (16) “Uninsured” individual means an applicant who: (a) Either: (i) Does not have private medical insurance, Medical Assistance, Medicare, or Maryland Children's Health Insurance Program coverage; or (ii) Has private medical insurance, Medical Assistance, Medicare, or Maryland Children's Health Insurance Program coverage that does not provide insurance coverage for medically necessary services for a cancer treatment service or tobacco treatment product; and (b) Does not have the financial means to pay for a cancer treatment service or tobacco treatment product as defined by the criteria established in this chapter. (17) “University of Maryland Medical Group (UMMG)” means the University of Maryland Medical Systems Corporation, the University of Maryland Medical School, and the University of Maryland, Baltimore. #### Regulation .03 Responsibilities of the Department. *COMAR 10.14.06.03* The Department shall: A. Establish guidelines for defining financial eligibility of an: (1) Uninsured or underinsured individual for the purpose of receiving cancer treatment services under the Cancer Prevention, Education, Screening and Treatment Program; and (2) Uninsured individual for the purpose of receiving tobacco treatment products under the Tobacco Use Prevention and Cessation Program; and B. Review the written documentation submitted by a local health department or Statewide academic health center to assure that the criteria listed in Regulations .05 and .06 of this chapter are followed. #### Regulation .04 Responsibilities of Local Health Departments and Statewide Academic Health Centers. *COMAR 10.14.06.04* A. If a local health department or a Statewide academic health center decides that grant funds under the Cigarette Restitution Fund Program will not be used to pay for cancer treatment services or tobacco treatment products: (1) This chapter does not apply; and (2) A local health department or a Statewide academic health center has no further responsibilities with respect to this chapter. B. If a local health department or a Statewide academic health center decides that grant funds under the Cigarette Restitution Fund Program will be used to pay for cancer treatment services or tobacco treatment products: (1) This chapter applies; and (2) A local health department or a Statewide academic health center shall adhere to the financial guidelines established by the Department for: (a) Cancer treatment services as set forth in Regulation .05 of this chapter; and (b) Tobacco treatment products as set forth in Regulation .06 of this chapter. #### Regulation .05 Criteria for Eligibility for Cancer Treatment Services. *COMAR 10.14.06.05* A. A local health department or a Statewide academic health center shall use the following financial eligibility criteria for cancer treatment services under the Cancer Prevention, Education, Screening and Treatment Program: (1) The basis for determining financial eligibility shall be the gross annual household income; (2) An applicant with a gross annual household income above 250 percent of the federal poverty level is not eligible to receive cancer treatment services; (3) Written documentation required for determination of the gross annual household income shall include: (a) The household’s most recent federal income tax return; or (b) If a household income tax return was not filed, the following: (i) The most recent W-2 statement; (ii) Pay stubs from two consecutive pays; (iii) A Social Security entitlement letter; or (iv) A notarized letter from the applicant stating that the applicant is not working and does not have any income; (4) The household income level for determining financial eligibility shall be based on the size of the family unit including the applicant and may include the following individuals as verified by the most recent tax return: (a) The applicant’s spouse; (b) Any financially dependent children; or (c) Any financially dependent relative; and (5) The type of written documentation that an applicant shall provide in order to document the size of the family unit includes the following: (a) The most recent income tax return; (b) A divorce decree, if applicable; or (c) If a household income tax return was not filed, written documentation shall include the names, ages, and relationship to the applicant of individuals supported by the gross annual household income. B. A local health department or a Statewide academic health center may establish requirements for eligibility of cancer treatment services in addition to those cited in §A of this regulation. #### Regulation .06 Criteria for Eligibility for Tobacco Treatment Products. *COMAR 10.14.06.06* A local health department shall make tobacco treatment products available free of charge to an individual participating in the Cigarette Restitution Fund Program. #### Regulation .07 Funding Availability. *COMAR 10.14.06.07* Payment under this chapter is contingent on the availability of funds in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland. ### Chapter 07 — Cord Blood Transplant Center Support Fund **Authority:** Health-General Article, §§13-3001 — 13-3004, Annotated Code of Maryland **Administrative History:** Effective date: April 28, 2014 (41:8 Md. R. 472) #### Regulation .01 Purpose and Scope. *COMAR 10.14.07.01* This chapter: A. Defines the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund; B. Describes how funds may be allocated to the Cord Blood Transplant Center Support Fund; C. Sets forth the responsibilities of the Maryland Department of Health and the Comptroller with respect to the Cord Blood Transplant Program and Cord Blood Transplant Center Support Fund; D. Outlines the grant application process for the Cord Blood Transplant Center Support Fund; and E. Outlines grantee reporting requirements. #### Regulation .02 Definitions. *COMAR 10.14.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Comptroller” means the Comptroller of the Treasury. (2) “Cord Blood Transplant Center” means a medical facility that: (a) Uses cells obtained from a human umbilical cord or placenta to treat pediatric or adult patients afflicted with a disease or injury; and (b) Is a member of the National Marrow Donor Program. (3) “Department” means the Maryland Department of Health. (4) “Fund” means the Cord Blood Transplant Center Support Fund. (5) Grant. (a) “Grant” means financial assistance from the State to support an applicant's activities related to cord blood transplantation. (b) “Grant” does not mean a contract. (6) “Program” means the Cord Blood Transplant Program. (7) “Qualified medical institution” means a medical institution that: (a) Is accredited by the Joint Commission on Accreditation of Health Care Organizations; (b) Is located in the State; (c) Has an established hematologic malignancies research program; and (d) Meets all requirements established in the request for proposals issued by the Cord Blood Transplant Program. (8) “Secretary” means the Secretary of Health. #### Regulation .03 Cord Blood Transplant Program. *COMAR 10.14.07.03* A. There is a Cord Blood Transplant Program in the Department. B. The purpose of the Program is to provide funding to qualified medical institutions to establish or maintain a cord blood transplant center. C. The Program administers the Fund to provide grants, subject to the limitations of the State budget, to qualified medical institutions to establish or maintain a cord blood transplant center. #### Regulation .04 Cord Blood Transplant Center Support Fund. *COMAR 10.14.07.04* A. The purpose of the Fund is to promote economic development by supporting cord blood transplant centers at qualified medical institutions with a goal of being recognized as a regional center of excellence in the area of cord blood transplantation. B. The Fund is: (1) A nonlapsing, special fund pursuant to Health-General Article, §13-3001, Annotated Code of Maryland; and (2) Not subject to the State Finance and Procurement Article, §7-302, Annotated Code of Maryland. C. The Fund consists of any: (1) Money appropriated in the State budget to the Fund; and (2) Other money from any other source accepted for the benefit of the Fund. D. The Department may only expend funds in accordance with an appropriation approved by the General Assembly in the annual State budget. E. The Department may only make grant awards under the Fund for the establishment of or support for a cord blood transplant center at a qualified medical institution. F. Any unspent portions of the Fund shall remain in the Fund and may not revert or be credited to the general fund of the State, nor any other special fund of the State. #### Regulation .05 Responsibilities of the Department. *COMAR 10.14.07.05* The Department shall: A. Administer the Program and perform related administration activities, including: (1) Develop and release an annual request for proposals; (2) Convene an expert panel to review applications and select grantees; and (3) Ensure that grantees remain in compliance with request for proposals requirements; B. Administer the Fund; C. Provide a grant or grants in each fiscal year, in accordance with the State budget, to qualified medical institutions; and D. Maintain records of grantee activities supported by the Fund. #### Regulation .06 Allowable Use of the Fund. *COMAR 10.14.07.06* A grantee may use awarded funds to establish or maintain a cord blood transplant center, which includes support of: A. Individuals engaged in the establishment or maintenance of a cord blood transplant center; and B. Equipment necessary for the establishment or maintenance of a cord blood transplant center. #### Regulation .07 Unallowable Use of the Fund. *COMAR 10.14.07.07* A grantee may not use awarded funds to pay for activities not provided for in the approved grant application. #### Regulation .08 Application Process for Cord Blood Transplant Center Grants. *COMAR 10.14.07.08* An applicant for a cord blood transplant center grant shall: A. Submit a completed application to the Department by the due date listed in the annual request for proposals; and B. Include in the application packet the following information as specified in the annual request for proposals: (1) Executive summary; (2) Statement of the need for funding; (3) Proposed work plan for the grant period; (4) Brief professional resume or curriculum vitae of key staff involved in the grant activities; (5) Description of how the requested funding will further the institution’s goal of being recognized as a cord blood transplantation regional center of excellence; (6) Timeline detailing the expected start and completion dates for each activity to be conducted under the grant; (7) Organizational chart indicating where the work under the grant will be located within the institution; (8) Statement that the grant money will not be used to supplant any existing funding; (9) Line item budget for the grant; and (10) Written budget justification. #### Regulation .09 Grant Application Review, Selection of Grantees, and Grant Extensions. *COMAR 10.14.07.09* A. The Department shall determine the amount of money available for grants under the Cord Blood Transplant Center Support Fund annually. B. Each year the Program shall consider awarding a grant to at least one qualified medical institution. C. The Program shall convene a grant evaluation committee to review the grant applications. D. Members of the evaluation committee may include one or more external individuals with expertise in cord blood transplantation. E. The evaluation committee shall review grant applications based on criteria stated in the Request for Proposals. F. The Program shall recommend a grant application to the Secretary for approval based on: (1) The evaluation committee's recommendations for awarding the grants; and (2) The availability of funds. G. The Secretary shall: (1) Consider the grant award recommendations of the Program; and (2) Make the final determination on which grant applications to approve. H. A grant period expires 1 year from the date of award of the grant. #### Regulation .10 Payments, Terms and Conditions of Grant Awards, and Terminations. *COMAR 10.14.07.10* A. Payments Under the Grant. (1) The Department may not make more than quarterly payments during the grant period to a grantee awarded a grant under this chapter. (2) Before the first payment under the grant, at the request of the grantee in their submitted grant application, the Department may approve an advanced payment for the grant based on financial need. (3) If a financial or progress report required in §B or C of this regulation is overdue, the Department may withhold payment until the report is submitted. B. Financial Reports and Records. (1) A grantee shall: (a) Establish a separate account to track expenditures under the grant; (b) Maintain accurate records, including documentation of each transaction pertaining to the grant; and (c) Submit to the Department quarterly invoices for payment and an annual financial expenditure report containing the signature of the financial officer of the entity affiliated with the grant award. (2) The Department may audit the accounts referenced in §B(1) of this regulation at any time. (3) Within 90 days after the date the grant period ends, a grantee shall submit to the Department: (a) A final financial expenditure report; and (b) A refund of any unexpended funds. (4) A grantee shall retain all records pertaining to a grant award for 3 years from the date the final financial expenditure report is submitted under §B(3) of this regulation. (5) In the case of an audit or litigation, the Department may extend the time period under §B(3) or (4) of this regulation until the completion of the audit or litigation. C. Progress Reports. (1) A grantee shall submit to the Program one electronic copy of: (a) An interim report describing the progress of the grant: (i) 6 months after the date of award of the grant; and (ii) Every 6 months until the end of the grant; and (b) Not later than 60 days after the date the grant period ends, a comprehensive final report, that provides a summary of all of the activity conducted under the grant. (2) The Department shall keep research results confidential as required by Health-General Article, §§4-101 — 4-103, Annotated Code of Maryland. D. Publications. (1) A grantee who publishes results from activities supported by a grant approved by the Secretary under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Cord Blood Transplant Center Support Fund of the Maryland Department of Health.” (2) A grantee shall provide the Department with one electronic copy of any published article pertaining to the activities conducted under the grant. E. Ownership of Equipment. A grantee: (1) Shall ensure that equipment purchased under a grant under this chapter is used for the sole purpose of the grant; (2) Shall keep an inventory of all equipment purchased; and (3) May not transfer the equipment to another entity without the written permission of the Department. F. Termination. (1) The Secretary may terminate a grant: (a) If a grantee fails to comply with: (i) The requirements of this chapter; or (ii) State, federal, and municipal laws applicable to the performance of research under the grant; (b) If a grantee fails to carry out the purposes for which the grant was awarded; (c) In compliance with a court order; or (d) At the request of the grantee. (2) The Department and the State are not responsible for any expenses incurred by a grantee after cancellation of a grant. (3) The grantee shall return all unexpended funds to the Department within 60 days of termination of a grant. G. Compliance with Existing Laws. A grantee shall ensure that an activity conducted in the performance of the grant is in compliance with all State, federal, and local laws. H. Liability. (1) A grantee is solely responsible for the institution's actions relating to the grant-making process or pertaining to activities conducted under a grant award. (2) The State and the Department are not liable for any claims, losses, liabilities, expenses, or damages arising from activities relating to the grant-making process or conducted under a grant awarded under this chapter. I. Grant Agreements. A grantee shall enter into a grant agreement with the Department. ### Chapter 08 — Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program **Authority:** Health-General Article, §§13-4001—13-4007, Annotated Code of Maryland **Administrative History:** Effective date: November 13, 2023 (50:22 Md. R. 975) #### Regulation .01 Purpose and Scope. *COMAR 10.14.08.01* This chapter sets forth the: A. Responsibilities of the Maryland Department of Health for the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program established by Health-General Article, §§13-4001—13-4007, Annotated Code of Maryland; B. Responsibilities of a grantee that receives funds under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program; C. Application process for a grant under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program; and D. Reporting requirements for the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. #### Regulation .02 Definitions. *COMAR 10.14.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an entity that applies to receive a grant under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. (2) Cancer Screening Test. (a) “Cancer screening test” means a test that is designed to find cancer in an individual who does not present cancer signs or symptoms. (b) “Cancer screening test” includes, but is not limited to: (i) A laboratory test; (ii) An imaging procedure; (iii) A medical procedure; and (iv) A genetic test. (3) “Cost effectiveness” means a comparison between cost and expected health outcomes of a cancer test or intervention. (4) “Department” means the Maryland Department of Health. (5) “Grant” means funds distributed to a grantee under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. (6) “Grantee” means a local fire department, volunteer fire department, or volunteer fire company approved to receive funds under the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. (7) “Health care provider” means a doctor of medicine or osteopathy, dentist, nurse practitioner, or physician assistant who is authorized to practice by the state in which the individual practices. (8) “Local fire department” means a fire department operating in a Maryland county or Baltimore City. (9) “Program” means the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program. (10) “Qualifications” means the education, experience, skills, and licensing of an individual associated with a Program grant application. (11) “Volunteer fire company” means a volunteer fire company operating in a Maryland county or Baltimore City. (12) “Volunteer fire department” means a volunteer fire department operating in a Maryland county or Baltimore City. #### Regulation .03 Responsibilities of the Department. *COMAR 10.14.08.03* The Department shall: A. Administer the Program; B. Provide one or more grants to local fire departments, volunteer fire companies, or volunteer fire departments to procure innovative cancer screening tests according to Health-General Article, §13-4003(a), Annotated Code of Maryland; C. Develop and distribute an application for Program grants each fiscal year if funding is available; D. Maintain a record of information submitted by a grantee to the Department; and E. Monitor the activities of a grantee to ensure compliance with the requirements of the Program. #### Regulation .04 Entities Eligible for Grants. *COMAR 10.14.08.04* The following entities are eligible to apply for and receive a grant from the Department under the Program: A. A local fire department; B. A volunteer fire company; C. A volunteer fire department; and D. If authorized by a local fire department, volunteer fire company, or volunteer fire department, a county. #### Regulation .05 Use of Grant Funds. *COMAR 10.14.08.05* A. A grantee may use awarded funds to: (1) Procure and administer innovative cancer screening tests that are not otherwise conducted during routine physical examinations or covered by insurance to professional firefighters employed by a local fire department and volunteer firefighters who serve in a volunteer fire company or department; and (2) Pay for activities directly associated with the grant that are approved by the Department. B. A grantee may not use awarded funds to pay for an activity that is not included in the approved grant application. #### Regulation .06 Application for Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program Grants. *COMAR 10.14.08.06* A. An applicant: (1) Shall submit a completed application to the Department by the due date listed in the request for applications; (2) Shall include in the application all required information listed in the request for applications, including: (a) The names and qualifications of the health care providers that will advise the applicant on the selection and administration of cancer screening tests; (b) The number of firefighters to be screened; (c) The selection criteria the applicant used to identify firefighters at the highest cancer risk based on the latest scientific and medical research; and (d) A description of each test to be procured by the applicant, including: (i) The claimed accuracy and reliability of the test; (ii) The scientific and clinical evidence supporting the claimed accuracy and reliability of the test; (iii) Whether the test employs innovative or novel technologies, such as DNA sequencing, genomics, proteomics, metabolomics, machine learning, artificial intelligence, big data analytics, or other state-of-the-art technology; (iv) Whether the test has the ability to simultaneously screen for two or more cancer types for which firefighters have a higher incidence or death rate; (v) The cost of the test; and (vi) Whether the test is developed, manufactured, or commercialized by a business entity located in the State; and (3) May voluntarily withdraw an application at any time. B. The county in which a volunteer fire company or department is located shall assist a volunteer fire company or a volunteer fire department in submitting an application. #### Regulation .07 Application Review, Selection of Grantees, and Grant Period. *COMAR 10.14.08.07* A. The Department shall: (1) Determine the amount of money available for grants under the Program in each fiscal year; (2) Develop a weighting formula to rate each application received by the Program; (3) Make available the weighting formula on the Program website and include the weighting formula in the request for applications; (4) Request additional information or changes to the application if necessary; and (5) Reject an application that does not meet the application requirements. B. The Department shall review and prioritize applications based on the quality of the application received and the degree to which the tests listed on the application meet the following criteria: (1) The scientific and clinical evidence supporting the claimed accuracy and reliability of test; (2) Whether the test employs innovative or novel technologies; (3) The ability of the test to simultaneously screen for two or more cancer types; (4) The cost effectiveness of the test; and (5) Whether the test is developed, manufactured, or commercialized by a business entity located in the State. C. The Department may review an application in consultation with one or more experts in cancer screening. D. If the Department receives applications for grant funds totaling more than the amount of funds appropriated for the Program, the Department shall award the funds on a pro rata basis. E. Funds shall be awarded under the Program for a maximum of 1 year.. #### Regulation .08 Payments, Terms and Conditions of Grant Awards, and Terminations. *COMAR 10.14.08.08* A. Payments. (1) The Department may approve an advance payment based on financial need. (2) If a financial or progress report required by §B or C of this regulation is overdue, the Department may withhold payment of funds to a grantee until the financial or progress report is submitted. B. Financial Reports and Records. (1) A grantee shall: (a) Establish a separate account to track expenditures under the grant; (b) Maintain accurate records, including documentation of each transaction associated with the grant; (c) Submit invoices for payment of grant funds to the Department within the deadline specified by the Department; (d) Submit a final report listing grant expenditures signed by the financial officer or designee of the grantee within the deadline specified by the Department; (e) Submit a final invoice for any unbilled expenditures within the deadline specified by the Department; and (f) Submit a refund of any unexpended funds within the deadline specified by the Department. (2) The Department may audit the accounts referenced in §B(1) of this regulation at any time. (3) A grantee shall retain all records pertaining to a grant for 3 years from the date the final report is submitted under §B(1) of this regulation. (4) In the case of an audit or litigation, the Department may extend the time period under §B(1) or (3) of this regulation until the completion of the audit or litigation. C. Progress Reports. A grantee shall submit to the Program: (1) Interim reports describing the progress of the grant; and (2) A comprehensive final report that provides a summary of all activities conducted under the grant no later than the deadline specified by the Department, including the: (a) Number of individuals screened; (b) Tests used; (c) Cost of the tests; and (d) Cancers detected by the tests. D. Publications. (1) A grantee who publishes results from activities supported by a grant approved under this chapter shall include in the publication the following acknowledgement: “Supported in part with funds from the Professional and Volunteer Firefighter Innovative Cancer Screening Technologies Program of the Maryland Department of Health.” (2) A grantee shall provide the Department with one electronic copy of any published article associated with an activity conducted under a grant. E. Ownership of Cancer Screening Tests. A grantee: (1) Shall ensure that a cancer screening test purchased under a Program grant is used for the sole purpose of the grant; (2) Shall keep an inventory of cancer screening tests purchased; and (3) May not transfer a cancer screening test to another entity without written permission from the Department. F. Termination. (1) The Department may terminate a grant: (a) If a grantee fails to comply with: (i) The requirements of this chapter; or (ii) State, federal, and municipal laws applicable to the grant; (b) If a grantee fails to carry out the purposes for which the grant was awarded; (c) In compliance with a court order; or (d) At the request of the grantee. (2) The Department may not be held responsible for any expenses incurred by a grantee after cancellation of a grant. (3) The grantee shall return all unexpended funds to the Department within 30 days of termination of a grant. G. Liability. (1) A grantee shall be solely responsible for its actions related to the: (a) Program application process; and (b) Activities conducted under a grant. (2) The Department may not be held liable for any claims, losses, liabilities, expenses, or damages arising from activities related to the: (a) Program application process; or (b) Activities conducted under a grant. ## Subtitle 15 — Food ### Chapter 01 — Low Acid and Acidified Food canning **Authority:** Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-321, 21-340, and 21-350, Annotated Code of Maryland **Administrative History:** Effective date: April 18, 1957 **Administrative History:** Chapter, Canneries, repealed effective January 22, 2001 (28:1 Md. R. 26) **Administrative History:** Regulations .01 — .10, Canning and Acidified Food Manufacturing, adopted effective January 22, 2001 (28:1 Md. R. 26) **Administrative History:** Chapter, Canning and Acidified Food Manufacturing, renamed, Low Acid and Acidified Food Canning, effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .02B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .05B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .06A, B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .07 amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .08 repealed effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .09 amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .10 amended effective February 15, 2016 (43:3 Md. R. 272) #### Regulation .01 Incorporation by Reference. *COMAR 10.15.01.01* In this chapter, all provisions of 21 CFR 113 and 114 are incorporated by reference. #### Regulation .02 Definitions. *COMAR 10.15.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acid foods” means foods that have a natural pH of 4.6 or below. (2) Acidified Foods. (a) “Acidified foods” means low-acid foods to which acid or acids or acid food or acid foods are added and that have a: (i) Water activity (aw) greater than 0.85; and (ii) Finished equilibrium pH of 4.6 or below. (b) “Acidified foods” includes, but is not limited to: (i) Beans, cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical fruits, and fish, singly or in combination; and (ii) Foods that are called, or may purport to be, “pickles” or “pickled”. (c) “Acidified foods” does not include: (i) Carbonated beverages, jams, jellies, or preserves; (ii) Acid foods that contain small amounts of low-acid food or foods and have a resultant finished equilibrium pH that does not significantly differ from that of the predominate acid or acid food, including such foods as standardized and nonstandardized food dressings and condiment sauces; and (iii) Foods that are stored, distributed, and retailed under refrigeration. (3) “Canned foods” means foods that are heat treated and hermetically sealed in a container for preservation. (4) “Commercially sterile” means the condition achieved by the: (a) Application of heat that renders the food free of: (i) Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and (ii) Viable microorganisms, including spores, that cause disease; or (b) Control of water activity and the application of heat that renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. (5) “Culinary grade steam” means steam that is free of deleterious or harmful matter that might adulterate food. (6) “Department” means the Maryland Department of Health or the Department's designee. (7) “Lot” means the product produced during a time period indicated by a specific code. (8) Low-Acid Foods. (a) “Low-acid foods” means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85. (b) “Low-acid foods” does not include tomatoes and tomato products having a finished equilibrium pH less than 4.7. (9) “Person-in-charge” means the licensee or other individual responsible for the overall conditions and operation of a cannery or acidified food processing plant. (10) “Process authority” means an individual having knowledge acquired through training about and experience with thermal processing requirements or the acidification and processing of acidified foods. (11) “Scheduled process” means the process selected by the processor as adequate under the conditions of manufacture that: (a) Is at a minimum equivalent to the process established by a process authority; (b) For thermally processed low-acid foods packaged in hermetically sealed containers: (i) Achieves a commercially sterile product; and (ii) May be in excess of that necessary to ensure destruction of microorganisms that cause disease; (c) For acidified foods: (i) Achieves and maintains a food that will not permit the growth of microorganisms that cause disease; and (ii) Includes the control of pH and other critical factors; and (d) For thermally processed acid foods packaged in hermetically sealed containers: (i) Achieves a commercially sterile product; or (ii) Ensures the destruction of microorganisms that cause disease and prevents spoilage during the product's shelf life. (12) “Thermal process validation study” means a scientific study conducted by a process authority to determine critical factors and establish and validate a food process. (13) “Water activity (aw)” means the measure of the free moisture in a product and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. #### Regulation .03 Conformance with Other Chapters. *COMAR 10.15.01.03* A. The person-in-charge shall ensure that a food processing plant is in compliance with this chapter and COMAR 10.15.04: (1) In the design, operation, and maintenance of the plant, its facilities, and equipment; and (2) When the plant is canning foods or manufacturing acidified foods, or both. B. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 regarding canning or acidified food manufacturing, this chapter takes precedence. #### Regulation .04 Licenses. *COMAR 10.15.01.04* A. In order to operate a cannery or acidified food processing plant, a person shall obtain a food processing license pursuant to the provisions of Health-General Article, §21-305, Annotated Code of Maryland, COMAR 10.15.04, and this chapter. B. The Department shall specify on a food processing license issued to a cannery or acidified food processing plant the following type or types of food the licensee is approved to produce: (1) Low-acid canned foods; (2) Acidified foods; (3) Acid canned foods; or (4) A combination of these types. C. The person-in-charge shall ensure that: (1) Foods are not canned and acidified foods are not manufactured in the plant without the license required by Health-General Article, §21-305, Annotated Code of Maryland; (2) The required food processing license is conspicuously posted in the plant during operations; and (3) The food canned or manufactured is limited to the type or types of foods stated on the license. #### Regulation .05 Plant Facilities and Operations. *COMAR 10.15.01.05* A. The person-in-charge shall provide and properly maintain, in good working and sanitary condition, the equipment and facilities needed to can food and manufacture acidified foods in accordance with applicable regulations. B. The person-in-charge shall ensure that: (1) The water supplied to a fixture is potable and meets the requirements of the Environment Article, Annotated Code of Maryland; (2) The sewerage system for the plant meets all applicable State and local codes and properly disposes of all wastewater; (3) Individuals in the plant: (a) Practice good personal hygiene; (b) While working with food, wash their hands frequently and directly after an activity that is likely to soil their hands; (c) Wear clean outerwear and no jewelry; and (d) Do not smoke or engage in any activity that might contaminate food; (4) Food contact surfaces are effectively cleaned and sanitized: (a) As often as needed to prevent food contamination; and (b) At a minimum: (i) Following processing; (ii) Between an interruption in processing of greater than 2 hours; and (iii) After a continuous use of 6 hours; (5) When a time greater than 8 hours separates the start of processing from previous cleaning and sanitizing, food contact surfaces are sanitized again before work resumes; (6) Non-food contact surfaces that: (a) Receive splash or waste are cleaned and sanitized: (i) As necessary to maintain a sanitary condition; and (ii) At a minimum following each day's use; and (b) Do not receive splash or waste are cleaned as often as necessary to maintain a sanitary condition; (7) Cleaning procedures are effective in removing soil and in preparing the surface for sanitizing when sanitizing is required; (8) The sanitization of surfaces is effective in killing pathogens that may be present on the surface; and (9) Clean equipment and utensils are stored to prevent their contamination. #### Regulation .06 Equipment. *COMAR 10.15.01.06* The person-in-charge shall ensure that: A. Processing equipment used to heat or cool food in hermetically sealed containers is: (1) Designed to provide even and adequate processing; (2) Provided adequate instrumentation and recording devices to allow process control, monitoring, and verification; (3) Durable and impervious to water; (4) Maintained in a sanitary and working condition; (5) Monitored to verify that process requirements are met; and (6) Calibrated according to a schedule approved by the Department; B. Food equipment other than that used for heating and cooling food in hermetically sealed containers is: (1) Non-toxic and does not impart any toxic or deleterious matter to the food; (2) Corrosion resistant; (3) Durable; (4) Impervious; and (5) Smooth and easily cleanable; C. Non-food contact equipment that receives splash or waste is smooth and easily cleanable; and D. Steam that might contact food is culinary grade steam. #### Regulation .07 Manufacturing Practices for Low-Acid Food and Acidified Food Canning. *COMAR 10.15.01.07* The person-in-charge shall ensure that: A. Low-acid foods are processed and labeled in accordance with 21 CFR 113; B. Acidified foods are processed and labeled in accordance with 21 CFR 114; C. When canning is taking place, a scheduled process is used that takes into account the critical factors and limits that are likely to influence the food’s safety, stability, or shelf life, such as: (1) Food characteristics; (2) Spoilage organisms; (3) Time and temperature of thermal process; (4) Cooling parameters; (5) Acidification; (6) Storage conditions; (7) Design and performance of the processing equipment; and (8) Batch size and configuration; D. Before a food processing plant processes food in a closed vessel, such as a retort or steam cabinet, a process authority performs a thermal process validation study that includes: (1) Heat penetration tests; (2) Heat distribution tests; (3) Cooling parameters; and (4) Any other measurements, observations, or calculations needed to ensure that the process is effective and reliable; E. The scheduled thermal process and validation study are re-established each time there is a change in the processing system; and F. All thermal processes and validation studies being used are available for inspection by the Department. #### Regulation .08 Manufacturing Practices for Acid Food Canning — Repealed. *COMAR 10.15.01.08* #### Regulation .09 Process Controls in Low Acid and Acidified Food Canning. *COMAR 10.15.01.09* The person-in-charge shall ensure that: A. The canning process is monitored and controlled as necessary to ensure the food's safety, stability, and shelf life; B. The cook time, cook temperatures, and pH of each batch of canned food are measured and recorded; C. Through strict processing criteria, monitoring, record keeping, and corrective action, a container of food processed as an acidified food is not distributed if the final pH measurement of the food is greater than 4.6 (4.7 for tomatoes and tomato products) when the food’s water activity is greater than 0.85; D. Sealing and seaming closure inspections are conducted to verify that containers are properly hermetically sealed; E. When a deviation from the scheduled process occurs: (1) The food manufactured during the deviation is: (a) Held for evaluation by a process authority; and (b) Completely reprocessed, destroyed, released, or otherwise disposed of in accordance with the decision of the process authority; and (2) The deviation and associated corrective action is documented in a record; F. Records are maintained to identify the initial distribution of the finished product to facilitate, when necessary, the segregation of specific food lots that may have become contaminated or otherwise rendered unfit for their intended use; and G. The records required in §§B, C, E, and F of this regulation are retained for at least 3 years from the date of manufacturing and are available for inspection by the Department. #### Regulation .10 Labeling and Marking of Containers. *COMAR 10.15.01.10* The person-in-charge shall ensure that: A. Canned food is conspicuously and prominently labeled or marked with the following information: (1) The common name of the food; (2) The list of ingredients in descending order of prominence by weight; (3) The name and address of the manufacturer or distributor; and (4) The net weight of the container; B. For a container marked with the name of the distributor, the name of the distributor is: (1) Preceded by the words “packed for” or “distributed by”; or (2) Followed by the word “distributor”; C. A container of canned low acid or acidified food is marked with a permanently visible identifying code that is: (1) Embossed or inked on the container; or (2) Perforated or otherwise marked on a label securely affixed to the product container, if the container does not allow embossing or inking; D. The identifying code required in §C of this regulation: (1) Specifies the following: (a) The establishment where the product was packed; (b) The product contained in the container; and (c) The year, day, and time period during which the product was packed; and (2) Is changed: (a) Every 4 to 5 hours; (b) With a personnel shift change; (c) With each batch, as long as the containers that constitute a batch do not extend over a period of more than one personnel shift; or (d) Otherwise often enough to enable ready identification of a lot during its sale and distribution; E. A container of product that needs to be refrigerated after opening to provide safety, stability, or shelf life is prominently and conspicuously marked with the statement “refrigerate after opening” or an equivalent statement; and F. False or misleading information is not placed on a container. ### Chapter 02 — Crab Meat **Authority:** Health-General Article, §§18-102, 21-211, 21-234, 21-304, 21-321, 21-339, 21-340, and 21-350, Annotated Code of Maryland **Administrative History:** Effective date: March 15, 1955 **Administrative History:** Amended effective September 3, 1957 **Administrative History:** Regulations .01—.06 amended effective September 14, 1977 (4:19 Md. R. 1468) **Administrative History:** Regulation .03C amended and .05-1 adopted effective September 30, 1994 (21:9 Md. R. 751) **Administrative History:** Regulations .01—.06 repealed and new Regulations .01—.15 adopted effective August 5, 2002 (29:15 Md. R. 1142) **Administrative History:** Regulation .01B amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .02 repealed effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .05B, C amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .07G amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .08C—E amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .09 amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .10 amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .11B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .11H, J amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .12 amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .13B, D amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .14 amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .15B, C amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .15C amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .15E repealed effective February 15, 2016 (43:3 Md. R. 272) #### Regulation .01 Definitions. *COMAR 10.15.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Back” means to remove a crab's outer shell. (2) “Boiled” means cooked by boiling in water that is bubbling rapidly, greatly agitated, and at a temperature of 212°F at sea level. (3) “Chum” means the parts of a cooked crab that are not eaten, and that are disposed of as waste material. (4) “Crab meat” means the edible meat of cooked crabs. (5) “Crab meat plant” means: (a) A picking plant; or (b) A place where crab meat is heat-treated to improve the keeping quality of the crab meat. (6) “Culinary grade steam” means steam that is free of deleterious or harmful matter that might adulterate food. (7) “Department” means the Maryland Department of Health or the Department's designee. (8) “Fresh crab meat” means cooked crab meat that has not been pasteurized or frozen. (9) “HACCP plan” means a Hazard Analysis Critical Control Point (HACCP) plan as specified in COMAR 10.15.10. (10) “Pasteurized crab meat” means cooked crab meat that is sealed in a container and further heat processed to improve the keeping quality of the meat. (11) “Person-in-charge” means the licensee or other person responsible for the operation of the crab meat plant. (12) “Picking plant” means a place where: (a) Crabs are cooked; (b) Crab meat is picked from crabs; and (c) Crab meat is packed for sale. (13) “Process authority” means an individual having knowledge acquired through training about and experience with thermal processing requirements for crabs and crab meat. (14) “Repack crab meat” means to pack crab meat by taking it from a container or package, when the crab meat has been picked from a crab at another location, and placing that crab meat in another container or package. (15) “Scheduled process” means a method or set of procedures determined by a process authority for processing crabs and crab meat, which takes into account the critical factors that may impact the food's safety or stability. (16) “Steamed” means cooked by exposure to steam in a cooker with the steam: (a) Under pressure, so that the temperature of the steam is greater than 212°F at sea level; or (b) At atmospheric pressure in a non-pressurized cooker. #### Regulation .02 Incorporation by Reference — Repealed. *COMAR 10.15.02.02* #### Regulation .03 Compliance with Other Chapters. *COMAR 10.15.02.03* A. The person-in-charge shall process crab meat and design, operate, and maintain a crab meat plant, its facilities, and equipment in compliance with this chapter and COMAR 10.15.04 and 10.15.10. B. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 or 10.15.10 regarding crab meat plants or the processing of crab meat, this chapter takes precedence. #### Regulation .04 Licenses. *COMAR 10.15.02.04* A. In order to operate a crab meat plant, a person shall obtain a food processing license pursuant to the provisions of: (1) Health-General Article, §21-305, Annotated Code of Maryland; (2) COMAR 10.15.04; and (3) This chapter. B. The Department shall specify on a food processing license it issues to a person operating a crab meat plant that the licensee is approved to process: (1) Fresh crab meat; (2) Pasteurized crab meat; (3) Repacked crab meat; or (4) Any combination of the above types of crab meat. C. The person-in-charge shall ensure that: (1) Crab meat is not processed without the license required by Health-General Article, §21-305, Annotated Code of Maryland; (2) The required food processing license is conspicuously posted in the plant; and (3) The operations in the plant are limited to the type of crab meat operation specified on the license pursuant to §B of this regulation. #### Regulation .05 Plant Facilities. *COMAR 10.15.02.05* A. The person-in-charge shall ensure that the equipment and facilities needed to process crab meat in accordance with the requirements of this chapter are provided and maintained in a sanitary and working condition. B. The person-in-charge shall ensure that: (1) The water supplied to a fixture is potable and meets the requirements of the Environment Article, Annotated Code of Maryland; (2) The sewage disposal system for the plant meets all applicable State and local codes and properly disposes of all wastewater; (3) Ice used in the manufacture of crab meat is produced from water that is potable and meets the requirements of the Environment Article, Annotated Code of Maryland; (4) The plant design and the flow of food through the plant minimize the potential for cross-contamination; (5) If uncooked crabs will be stored at the plant for more than 4 hours before cooking, a separate cooler is provided for uncooked crabs; (6) Partitions or linear distances are used to separate cooking areas, picking areas, and packing areas; (7) Floors in all processing areas and in refrigerated rooms are sloped to accessible floor drains that dispose of wastewater, in compliance with applicable plumbing codes; (8) Toilet rooms: (a) Are provided at the rate of one toilet for every 20 employees; (b) Do not open directly into a food processing or storage area; and (c) Are: (i) Separate for men and women; or (ii) Designed for use by not more than one person at a time. (9) A hand sink is: (a) Provided in the picking area at the rate of one hand sink for each 15 pickers; (b) Provided in the packing area; (c) Equipped with soap and paper towels for drying hands; (d) Accompanied by sanitizer in the picking and packing rooms for the sanitizing of hands; and (e) Equipped with hot and cold water under pressure; (10) A picking table is: (a) Adequate in size so that a picker does not contaminate crab meat during the picking of cooked crabs; and (b) Provided with sanitary paper towels in a dispenser within reach of a picker while at the table; (11) A three-compartment sink is: (a) Designed to allow immersion of utensils or equipment that will be cleaned and sanitized in the sink; (b) Provided in the plant for washing, rinsing, and sanitizing equipment and utensils; and (c) Equipped with hot and cold water under pressure; and (12) Waste containers are: (a) Provided inside the facility to be accessible to the workers; (b) Made to be easily cleanable; (c) Large enough to hold waste until the waste is taken off-site if the containers are outside waste containers; and (d) Vermin-proof, insect-proof, and placed on a hard and impermeable surface if the containers are outdoor waste containers, except in the case of chum containers that are removed daily. C. The person-in-charge may use a two-compartment sink instead of the three-compartment sink required in §B(11)(b) of this regulation, if the two-compartment sink: (1) Was installed before the effective date of this chapter; (2) Complies with all regulations applicable before the effective date of this chapter; (3) Performs the intended function; (4) Is maintained in a sanitary condition; and (5) When replaced, is replaced with a hand sink or three-compartment sink in full compliance with this chapter. #### Regulation .06 Plant Sanitation. *COMAR 10.15.02.06* The person-in-charge shall ensure that: A. Individuals in the plant: (1) Practice good personal hygiene; (2) Are excluded from working with food when the individuals are sick with an illness that is transmittable through food; (3) While working with food, wash the individuals' hands frequently and after an activity that is likely to soil the hands; (4) Wear clean outerwear, hair coverings, and no jewelry; (5) If handling crabs or crab meat, maintain trim and clean fingernails, and do not wear false fingernails; (6) Store personal items in a designated non-food area; and (7) Do not smoke or engage in an activity that might contaminate food; B. Picking trays, knives, and gloves are washed, rinsed, and sanitized before use and after each delivery of crab meat to the packing room; C. Except as provided in §B of this regulation, food contact surfaces are cleaned and sanitized: (1) As often as needed to prevent food contamination; and (2) At a minimum: (a) Following processing; and (b) Between an interruption in processing of greater than 2 hours; D. During processing, gross soil is removed from food contact surfaces and the surfaces are sanitized: (1) After a continuous use of 6 hours; and (2) After an interruption in processing of greater than 30 minutes; E. When a time greater than 8 hours separates the start of processing from previous cleaning and sanitizing, food contact surfaces are sanitized again before work resumes; F. Non-food contact surfaces that receive splash or waste are cleaned and sanitized: (1) As often as necessary to maintain a sanitary condition; and (2) At a minimum following each day's use; G. Cleaning procedures: (1) Include the use of detergents or other cleaning chemicals; and (2) Remove soils; H. The sanitization of surfaces is effective in killing pathogens on the treated surface; I. Non-food contact surfaces that do not receive splash or waste are cleaned as often as necessary to maintain a sanitary condition; J. Before cleaning, all food and food packaging is removed from the area being cleaned; K. Cleaning and sanitizing occur in a manner that protects food from contamination; L. In-use and cleaned equipment and utensils are stored to prevent contamination of the equipment and utensils; M. Waste, including chum, is held in a sanitary manner and disposed of to maintain the plant grounds in a sanitary condition; and N. Outdoor containers for chum that are not vermin-proof or insect-proof are removed daily and transported to a disposal site. #### Regulation .07 Equipment. *COMAR 10.15.02.07* The person-in-charge shall ensure that: A. Processing equipment is: (1) Designed to provide even and effective processing; (2) Provided with instrumentation to allow process control, monitoring, and verification; (3) Durable and impervious to water; (4) Maintained in a sanitary and working condition; (5) Monitored to verify that process requirements are met; and (6) Calibrated to ensure accuracy; B. Pasteurization equipment is provided with: (1) Temperature sensors: (a) For controlling and documenting the thermal process; and (b) That are located to give an accurate representation of the heating medium's temperature; (2) An automatic recording device of time and temperature that is: (a) Equipped with a reliable clock, so that a recorded interval does not exceed the elapsed time indicated by an accurate time piece; and (b) Equipped with a temperature measuring device that is scaled at a maximum of 2°F intervals within the operating temperature range of the pasteurization equipment and accurate to within ±1°F within the range spanning ±15°F of the target processing temperature; (3) An indicating thermometer scaled at a maximum of 2°F intervals within the operating range of the pasteurization equipment with an accuracy of ±1°F within the range spanning ±15°F of the target processing temperature; (4) Adequate agitation for even heating and cooling; and (5) Cooling water that contains residual free chlorine throughout the cooling process; C. A vessel for steaming crabs is provided with: (1) An indicating thermometer scaled at a maximum of 2°F intervals within the operating range of the vessel and accurate to within ±1°F within the range spanning ±15°F of the target processing temperature; (2) Vents to exhaust air thoroughly; (3) A bottom drain; (4) Steam pipe inlets or spreaders for even steam distribution; and (5) Culinary grade steam of sufficient volume for processing; D. In addition to what is required in §C of this regulation, a pressurized vessel is provided with: (1) When pressure is part of a standardized process, a pressure gauge; and (2) A pressure relief valve as required for safety; E. An accurate clock or timer is provided in the immediate vicinity of a heat-processing vessel to allow the accurate measurement of process time; F. Equipment used to process crab meat has food contact surfaces that are: (1) Non-toxic and do not impart toxic or deleterious matter to the food; (2) Corrosion resistant; (3) Durable; (4) Impervious; and (5) Smooth and easily cleanable; G. Tables used to back and pick crabs, and pack crab meat and food are made of stainless steel of American Iron and Steel Institute Type 304, or the equivalent; and H. Non-food contact equipment that receives splash or waste is smooth and easily cleanable. #### Regulation .08 Processing Practices. *COMAR 10.15.02.08* The person-in-charge shall ensure that: A. Crab meat is processed using sanitary practices, process controls, and a HACCP plan in compliance with COMAR 10.15.10; B. A process used for crab cooking or pasteurization is at least equivalent to a scheduled process; C. The scheduled process: (1) Is maintained in writing and available on-site; (2) Provides the heat lethality and rate of cooling prescribed in this chapter; (3) Establishes the time and temperature requirements for the processing system, which may include the: (a) Minimum time for exhausting air from the cooking or pasteurization vessel and a target temperature and pressure at the end of the exhaust; (b) Minimum processing temperature; (c) Minimum processing time after the cooking or pasteurization vessel reaches processing temperature; and (d) Cooling parameters; (4) Takes into account factors in the process that are likely to affect the lethality of the thermal process and the rate of cooling, which for pasteurization may include the: (a) Design and performance of the processing equipment; (b) Initial food temperature; (c) Batch size and configuration; and (d) Size and the shape of the crab meat container; (5) Is re-standardized each time there is a change in the processing system; and (6) Allows process monitoring; D. A thermometer used in conjunction with a cooking or pasteurization vessel is calibrated at least annually, or is certified by the National Institute of Standards and Technology with a valid certificate; and E. If pressure is part of the scheduled process, a pressure gauge, used in conjunction with a cooking or pasteurization vessel is calibrated at least annually. #### Regulation .09 Unit Processing Operations — Cooking. *COMAR 10.15.02.09* The person-in-charge shall ensure that: A. Live crabs received at the plant are stored in a manner that enhances the crab's survival and prevents decomposition; B. Crabs are steamed using a standardized process: (1) For a heat lethality equivalent to F(235°F) = 1 minute with z = 15°F, which is equivalent to bringing the internal temperature of the crabs instantaneously to 235°F, holding the internal temperature at 235°F for 1 minute, and then instantaneously cooling the crabs; or (2) Other than the one set forth in §B(1) of this regulation, if the alternative process has been shown through scientific study to provide: (a) Pathogen lethality; and (b) Equivalent conformance with the bacteriological standards set forth in Regulation .15 of this chapter; C. The cooling of cooked crabs conforms with the following: (1) Except as provided in Regulation .10C of this chapter, air cooling of cooked crabs at ambient air temperatures does not exceed more than 4 hours in length; (2) When cooked crabs are refrigerated before picking, the cooked crabs are placed in refrigeration at 40°F or below after cooling at ambient air temperatures; and (3) Except as provided in §D of this regulation, cooked crabs are: (a) Cooled and held before picking with the outer shell in place; and (b) Backed immediately before picking; and D. In order to provide a cold water rinse to remove sediment, when cooked dredged crabs are backed: (1) Before refrigeration, the crabs are air cooled, backed, and refrigerated within 4 hours after cooking; (2) After refrigeration, the crabs are backed, rinsed, and picked and the crab meat packed in: (a) A continuous process; and (b) Accordance with Regulation .10B of this chapter; or (3) With no refrigeration and directly before picking the cooked crabs are cooled, backed, and picked and the crab meat packed in: (a) A continuous process; and (b) Accordance with Regulation .10C of this chapter. #### Regulation .10 Unit Processing Operations — Picking and Packing. *COMAR 10.15.02.10* The person-in-charge shall ensure that: A. Cooked crabs are transferred to the pickers in containers dedicated to that purpose; B. For cooked crabs that are refrigerated before picking, within 3.5 hours after the crabs are removed from refrigeration, the: (1) Crabs are picked; and (2) Packed crab meat is cooled by: (a) Surrounding the packed crab meat with ice; or (b) Another effective and sanitary cooling method; C. For cooked crabs that are not refrigerated before picking, within 6 hours after the crabs are cooked, the: (1) Crabs are picked; and (2) Packed crab meat is cooled by: (a) Surrounding the packed crab meat with ice; or (b) Another effective and sanitary cooling method; D. The corrective action for crab meat that is not picked, packed, and iced or otherwise cooled within HACCP critical limits is documented in records; E. Containers in which crab meat is picked and packed are: (1) Made of suitable food-grade materials; (2) Protected from contamination; and (3) Rinsed in a bactericidal solution and completely drained immediately before being filled with crab meat; and F. Crab meat picked in the plant is not removed from the container into which it was picked and placed into another container, except when specific written approval for the transfer of crab meat from the original container into another container is given by the Department, based on a review of a written proposal plan to transfer the crab meat that complies with this chapter and includes the: (1) Type or types of crab meat to be placed from one container into another container; (2) Procedures to maintain the crab meat at temperatures that prevent the growth of pathogens and retard spoilage; (3) HACCP plan for the process, if a hazard analysis indicates that reasonably likely food safety hazards exist; (4) Food-grade specifications of a crab meat container; (5) Oxygen permeability of a crab meat container; (6) Procedures to protect crab meat from contamination; and (7) Labeling and marking of a crab meat container. #### Regulation .11 Unit Processing Operations — Repacking. *COMAR 10.15.02.11* The person-in-charge shall ensure that: A. Crab meat is repacked only in a licensed picking plant; B. Repacking does not occur except when written approval for the repacking is given by the Department, based on a review of a written proposal plan to repack that complies with this chapter, and includes the: (1) Information in Regulation .10G of this chapter; (2) If imported crab meat will be repacked, name of the person responsible for ensuring compliance with §H(7) of this regulation; and (3) Source of the crab meat; C. Frozen crab meat is not repacked; D. Crab meat that is repacked into a container is: (1) From a single plant; and (2) Completely comprised of crab meat that was picked, packed, or pasteurized on the same day; E. Once repacked, crab meat is not repacked again; F. An empty container from which crab meat has been repacked is placed immediately into a waste disposal receptacle and is not kept on the premises for reuse; G. Repacking is done in a sanitary manner in accordance with the provisions of this chapter; H. Crab meat for repacking is: (1) Processed in a licensed plant operating under a HACCP plan; (2) Wholesome; (3) Received in its original container and marked with the date of pasteurization as required in Regulation .14 of this chapter; (4) Crab meat that meets the bacteriological standards in Regulation .15 of this chapter; (5) If pasteurized, stored at 40°F or below before repacking; (6) When fresh: (a) Repacked within 72 hours of the original pick and pack; and (b) Stored in ice or held at 40°F or less before repacking; and (7) When imported crab meat, sampled and tested for Standard Plate Count and Escherichia coli by an accredited laboratory using a composite sample from 5 separate containers and standard methods approved by the Secretary based on the ability of the methods to provide accurate and repeatable results; I. Repacked crab meat not for pasteurization is: (1) Maintained at 40°F or below during repacking; and (2) Rapidly cooled after repacking by surrounding the packed crab meat in ice or some other sanitary and effective means; J. Repacked crab meat for pasteurization is: (1) Maintained at 40°F or below during repacking and in storage before pasteurization; (2) Pasteurized within 96 hours of the original pick and pack; and (3) Pasteurized, cooled, and stored in accordance with Regulations .08, .12, and .13 of this chapter; and K. Repack records: (1) Are maintained to allow crab meat to be traced to the original picking plant; (2) Include the following information: (a) The name, address, and plant number of the original picking plant; (b) The type and quantity of the crab meat that is repacked; (c) The original pick, pack, or pasteurization date and the repack date; and (d) Results of the microbiological laboratory testing required in Regulation .11H(7) of this chapter; and (3) Are available for inspection by the Department for 2 years following the date of repacking. #### Regulation .12 Unit Processing Operations — Pasteurization. *COMAR 10.15.02.12* The person-in-charge shall ensure that: A. When crab meat is picked in one plant for pasteurization at another: (1) The crab meat is transported in the final container; (2) A temporary cover that effectively protects the crab meat is placed on the can until seaming or sealing when the crab meat container will be seamed or sealed at a plant other than where it was filled; and (3) The final product is labeled according to the requirements of Regulation .14 of this chapter; B. When a container is hermetically sealed: (1) The container is covered or otherwise protected before sealing or seaming; and (2) At a minimum, the seals or seams are inspected: (a) At the start of sealing or seaming; (b) At a minimum of every 4 hours during sealing and seaming; and (c) When the sealing or seaming equipment malfunctions; C. Crab meat that has been placed in containers and the containers sealed or seamed for pasteurization: (1) Is pasteurized within 48 hours of sealing or seaming; and (2) Receives a standardized process for a heat lethality equivalent to F(185°F) = 31 minutes with z = 16°F; D. Immediately following pasteurization, pasteurized crab meat is continuously cooled to 55°F within 3 hours and to 40°F within an additional 15 hours; E. When a recording chart is used to record the time and temperature of pasteurization: (1) A continuous inked record is made of process time and temperature during pasteurization; (2) A new chart or section of chart is used for each pasteurization operation; (3) The used charts that document a pasteurization process are kept on file in the plant, and available for inspection by the Department for a period of 2 years; and (4) The following information is placed on the recorder chart form or another comparable form that documents that a pasteurization process is used: (a) Process date; (b) Plant name and number; (c) Batch code; (d) Quantity of each batch; (e) Initial temperature of the crab meat when the temperature is a critical factor; (f) Indicating thermometer reading after the target temperature has been reached and stabilized; (g) Occurrence of any mechanical or power failure or the opening of the recording thermometer case for adjustments or repair during a thermal process cycle; and (h) Written signature of the operator of the pasteurization equipment; and F. When a computer-based data logger or data acquisition device is used to record the time and temperature of pasteurization, the information required in §E(4) of this regulation is: (1) Recorded; and (2) Available as a permanent copy for inspection by the Department for a period of 2 years. #### Regulation .13 Unit Processing Operations — Storage. *COMAR 10.15.02.13* The person-in-charge shall ensure that: A. After being picked and packed in ice, blast chilled, or otherwise cooled in a sanitary and effective way, fresh crab meat is kept in ice or in an ambient air temperature of 40°F or less; B. Except when pasteurized within 2.5 hours of weigh-up in the packing room, packed crab meat for pasteurization is kept in ice or in an ambient air temperature of 40°F or below until pasteurization; C. Pasteurized crab meat in hermetically sealed containers is kept in an ambient air temperature of 38°F or below; D. Reduced oxygen packaged non-pasteurized crab meat is kept frozen; and E. Crab meat is protected from contamination during storage. #### Regulation .14 Labeling and Marking of Crab Meat Containers. *COMAR 10.15.02.14* The person-in-charge shall ensure that: A. The information required on a container of crab meat is marked by: (1) Embossing; (2) Imprinting; (3) Lithography; or (4) Another method approved by the Department based on its: (a) Durability; and (b) Ability to remain on the container for the shelf life of the crab meat in a form that is: (i) Conspicuous; and (ii) Legible; B. The following information is marked on a container of crab meat: (1) The common name of the food; (2) The name and address of the picking plant or distributor; (3) If a chemical is added to the crab meat, a statement to that effect; (4) The license number of the plant preceded by the State abbreviation applicable to the picking plant; and (5) The net weight of the contents of the container; C. For a container marked with the name of the distributor, the name of the distributor is: (1) Preceded by the words “packed for” or “distributed by”; or (2) Followed by the word “distributor”; D. When the packing and pasteurization are completed at different plants, the label clearly states the license numbers of the packer and pasteurizer; E. For a container of pasteurized crab meat, whenever the term “crab meat” or its equivalent appears on the label, the word “pasteurized” is stated with equal prominence and in immediate conjunction with the term “crab meat”; F. A container of pasteurized crab meat is marked with a batch code that indicates the date of picking, packing, or pasteurization; G. Except when crab meat is frozen, the words “keep refrigerated” or equivalent words are placed on a container of fresh or pasteurized crab meat; H. The words “keep frozen” or equivalent words are prominently displayed on the label of a container of frozen crab meat; I. If crab meat is in a frozen state after being manufactured, processed, or packaged and it then is offered for sale in an unfrozen state, the container's labeling contains a clear and conspicuous statement that the crab meat was previously frozen and should not be refrozen; J. A container of crab meat containing crab meat picked from a crab, packed, repacked, or processed outside of the United States: (1) Is marked with the words “This product contains crab meat from (name of country of origin)”; and (2) The marking required in §J(1) of this regulation is prominently displayed in letters not smaller than 12-point type on the principal display panel; K. A container of crab meat containing crab meat picked from a crab other than a “blue crab” (C. sapidus) is marked with the common name and scientific name of the crab picked into the container; L. False or misleading information is not placed on a container of crab meat; and M. A container of repacked crab meat is marked: (1) With the date of the repack, which may be a code date; (2) With the crab meat plant numbers of both the original packer and repacker; and (3) To allow the crab meat to be traced back to both the repacker and original packer. #### Regulation .15 Bacteriological Standards. *COMAR 10.15.02.15* A. The person-in-charge: (1) Shall ensure that crab meat is processed to meet the bacteriological standards set forth in this regulation; and (2) May not distribute crab meat that does not meet these standards. B. To establish whether compliance is met with the bacteriological standards for crab meat set forth in §§C and D of this regulation, a person shall utilize the isolation, identification, and enumeration methods that are approved by the Secretary based on the ability of the methods to provide accurate and repeatable results. C. The bacteriological standards for crab meat that is not pasteurized are the following: (1) Generic Escherichia coli may not exceed a Most Probable Number of 3.6 per gram of fresh crabmeat; (2) Listeria monocytogenes and enterohemorrhagic Escherichia coli may not be present in fresh crab meat; and (3) Standard Plate Count may not exceed 100,000 colony-forming units per gram of crab meat. D. The bacteriological standards for pasteurized crab meat are the following: (1) Escherichia coli may not be present in pasteurized crab meat; (2) Listeria monocytogenes may not be present in pasteurized crab meat; and (3) Standard Plate Count may not exceed 25,000 colony-forming units per gram of crab meat. ### Chapter 03 — Food Service Facilities **Authority:** Agriculture Article, §4-311; Health-General Article, §§18-102, 21-101, 21-102, 21-211, 21-202, 21-234, 21-301, 21-304, 21-308, 21-309.1, 21-309.2, 21-324.1, and 21-330.1; Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1976 (2:28 Md. R. 1669) **Administrative History:** Regulations .01; .02K, N, X; .03A, B; .05B; .06D, G; .07A—C; .08B amended and .02Q-1 adopted effective December 19, 1983 (10:25 Md. R. 2268) **Administrative History:** Regulation .02X adopted effective September 21, 1979 (6:19 Md. R. 1518) **Administrative History:** Regulations .03B, .05B, .07E, and .09B, C amended effective September 21, 1979 (6:19 Md. R. 1518) **Administrative History:** Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882); adopted permanently effective December 25, 1989 (16:25 Md. R. 2710) **Administrative History:** Regulation .01B amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .01C adopted effective March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulation .02B amended effective February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403); July 27, 1998 (25:15 Md. R. 1191) **Administrative History:** Regulation .03G amended effective March 4, 1991 (18:4 Md. R. 447); February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403) **Administrative History:** Regulation .04B and F amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .04C amended effective October 6, 1997 (24:20 Md. R. 1403) **Administrative History:** Regulation .06A amended effective March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulation .09A, B, and D amended effective March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulation .10 amended effective March 4, 1991 (18:4 Md. R. 447); February 15, 1993 (20:3 Md. R. 259); October 6, 1997 (24:20 Md. R. 1403) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted effective March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulation .11B and C amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .12 recodified to Regulation .25 effective March 4, 1991 **Administrative History:** Regulations .12—.24 adopted effective March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulation .18A amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Form DHMH 205 repealed effective March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulations .01—.25 repealed and new Regulations .01—.39 adopted effective December 17, 2007 (34:25 Md. R. 2211) **Administrative History:** Regulation .02B amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .02B amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .02B amended effective February 3, 2012 (39:1 Md. R. 17); March 4, 2013 (40:4 Md. R. 346); February 15, 2016 (43:3 Md. R. 272); December 31, 2018 (45:26 Md. R. 1245); October 5, 2020 (47:20 Md. R. 875); December 11, 2023 (50:24 M. R. 1042) **Administrative History:** Regulation .04 amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .04E amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .06 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .06C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .07A amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .07B amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .08B amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .09 amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .09D amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .10 amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .10A amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .11 amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .11C amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .12A amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .14F amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .14I amended effective February 3, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .15 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .15A amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .16 amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .17G amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .18H, I amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .19A amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .20 amended effective March 4, 2013 (40:4 Md. R. 346) **Administrative History:** Regulation .21 amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .22B, I amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .23 amended effective February 3, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .23L amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .24B amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .25 amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .25 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .25A, B amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .25C amended effective December 31, 2018 (45:26 Md. R. 1245); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .26 amended effective March 19, 2010 (37:4 Md. R. 341); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .26G amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .27 amended effective March 19, 2010 (37:4 Md. R. 341); February 3, 2012 (39:1 Md. R. 17); March 4, 2013 (40:4 Md. R. 346); October 5, 2020 (47:20 Md. R. 875); December 11. 2023 (50:24 Md. R. 1042) **Administrative History:** Regulation .27A amended effective December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .27C amended effective February 15, 2016 (43:3 Md. R. 272); December 27, 2021 (48:26 Md. R. 1111) **Administrative History:** Regulation .27C amended as an emergency provision effective November 27, 2024 (51:26 Md. R. 1185); amended permanently effective April 28, 2025 (52:8 Md. R. 358) **Administrative History:** Regulation .28 amended effective February 3, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .28C, E amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .28 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .28G, J amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .28J, K adopted effective December 31, 2018 (45:26 Md. R. 1245) **Administrative History:** Regulation .30B amended effective October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .30B, C amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .30C amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .32, Choking Posters, renamed, Required Postings and amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .33A, C amended effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .33C, D amended effective February 3, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .38 amended as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); amended permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .40 adopted effective October 5, 2020 (47:20 Md. R. 875) #### Regulation .01 Scope. *COMAR 10.15.03.01* This chapter: A. Governs food service facilities in Maryland; B. Along with COMAR 10.15.04, 15.04.01, and 15.11.11, establishes the standards for the control of Salmonella Enteritidis in shell eggs and egg-producing chickens as part of a program jointly administered by the Maryland Department of Health and the Maryland Department of Agriculture; and C. Is not intended to govern the food service operations in a child care center as defined in Family Law Article, §5-570, Annotated Code of Maryland, or a family day care home as defined in Family Law Article, §5-501, Annotated Code of Maryland, unless the food service operation is conducted in conjunction with another institution that is governed by this chapter. #### Regulation .02 Definitions. *COMAR 10.15.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acceptable” means agreeable to the use or presence of equipment or a practice when standards are not developed or when developed standards are inappropriate, because the approving authority has determined that the equipment or practice conforms to principles, practices, and generally recognized standards that protect public health. (2) Adulterated. (a) “Adulterated” has the meaning stated in Health-General Article, §§21-207, 21-208, and 21-209, Annotated Code of Maryland. (b) “Adulterated” includes food that: (i) Contains any poisonous or deleterious substance; (ii) Is diseased, contaminated, filthy, putrid, or decomposed; or (iii) Is otherwise unfit as food for human beings. (3) “Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source: (a) Are not adulterated or misbranded; and (b) Where required, are regulated by the approving authority. (4) “Approving authority” means: (a) Within the State, the Secretary of Health or the Secretary's designee; or (b) Outside the State, the agency designated in the laws of another state or country to license or permit a food establishment. (5) “aw” means water activity, which is: (a) The ratio of the water vapor pressure of a food to the vapor pressure of pure water at the same temperature; and (b) An index of the available, free moisture in food. (6) Bake Sale. (a) “Bake sale” means a place where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event. (b) “Bake sale” does not include a place: (i) Where a person sells baked goods for individual profit; (ii) From which food is commercially distributed; or (iii) Where a potentially hazardous baked good is sold or distributed. (7) “Barrier” means a physical, biological, or chemical factor that retards or prevents the growth of microorganisms that are infectious or toxigenic. (7-1) “Base of operations” means a licensed food service facility that is used by the owner or operator of a mobile food service facility for food storage, potable water, safe disposal of waste and sewage, and, if necessary, utensil washing. (8) “Bed and breakfast” means a lodging or rooming house as defined in Public Safety Article, §9-201, Annotated Code of Maryland, that has eight rooms or fewer for rent. (9) “Bona fide nonprofit” means an organization having official documentation from the United States Internal Revenue Service that the organization has current tax-exempt nonprofit status. (10) “Caterer” means a food service facility that: (a) Offers catering services; or (b) Identifies itself as a caterer. (11) “Catering services” means the preparation or provision and the serving of food or drink by a food service facility for service at the provider's premises or elsewhere in connection with a: (a) Specific public event; or (b) Business or social function or affair. (12) “Commercially sterile” means the condition achieved by the: (a) Application of heat, pressure, or other energy or matter that renders a food free of: (i) Microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution; and (ii) Viable microorganisms, including spores, that may cause disease; or (b) Control of water activity and the application of heat, pressure, or other energy or matter that renders the food free of microorganisms capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. (13) Comminuted. (a) “Comminuted” means reduced in size by methods including: (i) Chopping; (ii) Flaking; (iii) Grinding; or (iv) Mincing. (b) “Comminuted” includes fish, meat, or a mixture of products that are reduced in size and restructured or reformulated, such as: (i) Gefilte fish; (ii) Formed roast beef; (iii) The meat used in gyros; (iv) Ground beef; and (v) Sausage. (14) “Condiment” means a food or seasoning used to enhance the flavor of another food, including: (a) Mustard; (b) Ketchup; (c) Mayonnaise; (d) Relish; (e) Salt; (f) Pepper; (g) Sugar; or (h) Chutney. (14-1) “Consumer” means a person who is a member of the public, takes possession of food, is not functioning in the capacity of an operator of a food service facility or food processing plant, and does not offer the food for resale. (15) “Consumer advisory” means a written notification to consumers that: (a) Identifies food of animal origin that is served or sold as a ready-to-eat food or as an ingredient in a ready-to-eat food that is: (i) Raw; (ii) Undercooked; or (iii) Not otherwise processed to eliminate pathogens; and (b) Reminds consumers that consuming raw or undercooked meats, poultry, seafood, shellfish, or eggs may increase the risk of foodborne illness, especially if the consumer has certain medical conditions. (16) Continental Breakfast. (a) “Continental breakfast” means a meal that does not require major food preparation as specified in Regulation .28G(1) of this chapter. (b) “Continental breakfast” includes foods such as: (i) Coffee and tea; (ii) Juice; (iii) Cereal; (iv) Milk and cream; (v) Whole fresh fruit; (vi) Pastries; (vii) Bread; (viii) Donuts; (ix) Butter and margarine; and (x) Jams and jellies. (c) “Continental breakfast” does not include foods such as: (i) Eggs cooked outside of the shell; (ii) Meat; and (iii) Fruit salad prepared on premises. (17) “Corrosion resistant” means the property that allows a material to maintain sanitary surface characteristics under the influence of prolonged contact with: (a) Food; (b) Cleaning compounds; (c) Sanitizing solutions; and (d) Other conditions of the environment. (17-1) “Cottage food business” means a business that: (a) Produces or packages cottage food products in a residential kitchen in Maryland; and (b) Has annual revenues from the sale of cottage food products in an amount not exceeding $50,000. (17-2) “Cottage food product” means: (a) A non-potentially hazardous food as specified in Regulation .27 of this chapter that is offered for sale: (i) Directly to a consumer from a residence, by personal delivery, by mail delivery, at a farmer’s market, or at a public event; or (ii) To a retail food store if the cottage food product remains in the original packaging; and (b) A food that is not offered for sale through interstate commerce. (17-3) “County of origin” means the county in which the base of operations of a mobile food service facility is located. (18) “Critical control point (CCP)” means a point in the preparation or processing of food where there is a reasonable likelihood that improper control may cause, allow, or contribute to a hazard to public health. (19) Critical Item. (a) “Critical item” means a food safety requirement that if violated requires: (i) Immediate correction; (ii) The cessation of some or all processing operations; or (iii) Plant closure. (b) “Critical item” includes the following requirements: (i) Obtaining food from an approved source; (ii) Protecting food from adulteration, spoilage, and contamination; (iii) Restricting food workers with infection or diarrhea in accordance with COMAR 10.06.01; (iv) Ensuring that all food workers wash hands thoroughly before touching food and utensils, and as often as needed to prevent food contamination from hand contact; (v) Cooling potentially hazardous foods in accordance with the requirements of this chapter; (vi) Holding potentially hazardous foods at the hot and cold temperatures specified in this chapter; (vii) Cooking and reheating potentially hazardous foods in accordance with the requirements of this chapter; (viii) Providing potable hot and cold running water; and (ix) Discharging sewage from the facility in accordance with all applicable State and local codes. (20) “Critical limit” means the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to minimize the risk that an identified potential food safety hazard may occur. (21) “Department” means the Maryland Department of Health or the Department's designee. (22) “Detention order” means a written notification by the approving authority to the person-in-charge of a food service facility to detain food that may be adulterated or misbranded, pending a determination of the food's status and disposition in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland. (23) “Easily cleanable” means the property of a surface that allows the surface to: (a) Be readily accessible; and (b) Have soil and residue removed by routine cleaning methods. (24) “Egg carton” means a container holding up to 36 shell eggs, including overwrapped cartons and sleeves, that is used to pack shell eggs for distribution or sale to a consumer. (25) “Egg case” means a container that: (a) Is not a carton; (b) Holds either loose shell eggs or cartons of eggs; and (c) Is used to pack shell eggs for distribution or sale to a consumer. (26) “Employee” means: (a) The licensee; (b) An individual having supervisory or management duties; (c) An individual on the payroll; (d) A volunteer; (e) An individual performing work under contractual agreement; or (f) Any other individual working in a food service facility. (27) Equipment. (a) “Equipment” means an item, other than a utensil, that is used in the operation of a food establishment for: (i) Storage; (ii) Preparation; (iii) Display; (iv) Washing; or (v) Transportation. (b) “Equipment” includes a: (i) Stove; (ii) Oven; (iii) Hood; (iv) Slicer; (v) Grinder; (vi) Mixer; (vii) Scale; (viii) Meat block; (ix) Table; (x) Food shelf; (xi) Refrigerator; (xii) Freezer; (xiii) Sink; (xiv) Ice maker; or (xv) Another item used in the operation of a food service facility. (c) “Equipment” does not include a: (i) Forklift truck; or (ii) Dolly. (28) “Excluded organization” means a volunteer fire company or bona fide nonprofit fraternal, civic, war veterans’, religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week, except that once a year an organization may serve food to the public for up to 30 consecutive days. (29) Farm. (a) “Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes. (b) “Farm” includes a place where, for commercial purposes: (i) Crops are grown and harvested; (ii) Fruit, nuts, or other agricultural commodities are harvested from trees; or (iii) Animals are raised, fed, and managed for meat or other agricultural commodities. (30) Farmer's Market. (a) “Farmer's market” means a place where a person offers or sells one or more of the following food products directly to the public: (i) Raw agricultural products; (ii) Products processed in a private home kitchen, as set forth in Regulation .27 of this chapter; (iii) Products that are not potentially hazardous and do not require refrigeration that are processed in a food processing plant licensed and operated according to COMAR 10.15.04.19; or (iv) Eggs in compliance with Regulation .05A(8) of this chapter. (b) “Farmer's market” does not include a food service facility. (31) “Food” means: (a) A substance that is used as: (i) Food or drink for human beings; or (ii) A component of food or drink for human beings; or (b) Chewing gum or any substance that is a component of chewing gum. (32) “Food-contact surface” means a surface: (a) Of equipment and utensils with which food normally comes in contact; or (b) From which food may drain, drip, or splash onto a: (i) Food; or (ii) Surface normally in contact with food. (33) “Food processing plant” has the meaning stated in COMAR 10.15.04.02B. (34) Food Service Facility. (a) “Food service facility” means: (i) A place where food or drink is prepared for sale or service on the premises or elsewhere; or (ii) An operation where food is served to or provided for the public with or without charge. (b) “Food service facility” includes: (i) A restaurant, coffee shop, cafeteria, short order cafe, luncheonette, tavern, sandwich stand, soda fountain, retail market, or retail bakery outlet; (ii) A food operation in an industry, institution, health care facility, club, school, camp, church, catering kitchen, commissary, or a similar place in which food or drink is prepared for sale or for service on the premises or elsewhere; and (iii) A micro market licensed under Business Regulation Article, Title 17, Subtitle 17, Annotated Code of Maryland, and meeting the requirements of this chapter as a food service facility. (c) “Food service facility” does not include a: (i) Facility that offers only prepackaged foods that are not potentially hazardous as specified in §B(55)(c) of this regulation; (ii) Kitchen in a private home where food is prepared at no charge for guests in the home, for guests at a social gathering that is not a public event, or for service to unemployed, homeless, or another disadvantaged population; (iii) Food preparation or serving area where food is prepared or served only by an excluded organization; (iv) Hotel, lodging, or rooming house that serves only a continental breakfast; (v) Farmer’s market or a public event where food products as specified in §B(30)(a) of this regulation are sold; (vi) Bake sale where only non-potentially hazardous bakery goods, including breads and pastries, are sold in conjunction with a fundraising event; or (vii) Cottage food business. (35) Game Animal. (a) “Game animal” means an animal: (i) That is food for human beings; and (ii) That is not classified as cattle, sheep, swine, goat, mule, or other equine. (b) “Game animal” includes: (i) Reindeer; (ii) Elk; (iii) Deer; (iv) Antelope; (v) Water buffalo; (vi) Bison; (vii) Rabbit; (viii) Squirrel; (ix) Opossum; (x) Raccoon; (xi) Nutria; (xii) Muskrat; (xiii) Bear; and (xiv) Nonaquatic reptiles such as land snakes. (c) “Game animal” does not include ratites such as: (i) Ostrich; (ii) Emu; and (iii) Rhea. (36) “Hazard” means a biological, chemical, or physical property that may be detrimental to public health. (37) “Hazard analysis critical control point (HACCP) plan” means a written plan that delineates the procedures for maintaining control of potentially hazardous food at the critical control points of food preparation or processing. (38) Health Care Facility. (a) “Health care facility” means: (i) A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (ii) A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (iii) An ambulatory surgical facility or center as defined in Health-General Article, §19-114, Annotated Code of Maryland; (iv) An inpatient facility that is organized primarily to help in the rehabilitation of disabled individuals, through an integrated program of medical and other services provided under competent professional supervision; (v) A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland; (vi) A hospice facility, as defined in Health-General Article, §19-901, Annotated Code of Maryland; or (vii) Another health institution, service, or program for which Health-General Article, §19-114(d)(1)(ix), Annotated Code of Maryland, requires a certificate of need. (b) “Health care facility” does not include the facilities, institutions, and offices set forth in Health-General Article, §19-114(d)(2), Annotated Code of Maryland. (39) “Hermetically sealed container” means a container that: (a) Is secure against the entry of microorganisms; and (b) Maintains the commercial sterility of the contents after processing. (40) “Juice” means: (a) The aqueous liquid expressed or extracted from one or more fruits or vegetables; (b) Purees of the edible portion of one or more fruits or vegetables; or (c) Any concentrate of the liquid or puree as referenced in §B(40)(a) and (b) of this regulation. (41) “License” means the authority to operate a food service facility within the State in accordance with this chapter and Health-General Article, Title 21, Subtitles 1, 2, and 3, Annotated Code of Maryland. (42) “Loose eggs” means shell eggs not contained in a carton. (43) “Lot designation” means a method of marking packed or packaged shell eggs to enable the packer and the approving authority to trace the eggs to the flock that produced the eggs. (44) Major Food Allergen. (a) “Major food allergen” means: (i) Milk; (ii) Egg; (iii) Fish such as bass, flounder, or cod; (iv) Crustacea such as crab, lobster, or shrimp; (v) Tree nuts such as almonds, pecans, or walnuts; (vi) Wheat; (vii) Peanuts; (viii) Soybeans; and (ix) A food ingredient that contains protein derived from milk, egg, fish, tree nuts, wheat, peanuts, or soybeans. (b) “Major food allergen” does not include: (i) A highly refined oil derived from a food specified in §B(44)(a) of this regulation and any ingredient derived from a highly refined oil; or (ii) An ingredient that is exempt in regard to food allergen labeling requirements under the petition or notification process specified in 21 U.S.C. §343(w)(6) and (7). (44-1) “Micro market” means an unstaffed, self-checkout retail food service facility that: (a) Includes one or more micro market displays; (b) Has an automated payment kiosk or other device designed to accept electronic payments that is operated by the consumer; (c) Is located indoors and within a separate business; and (d) Is generally accessible only to individuals within the building in which the food service facility is located. (44-2) “Micro market display” means the place where the food being sold by a micro market is displayed, including: (a) An open rack; (b) A refrigerator or a refrigerated cooler; (c) A freezer; (d) A vending machine; (e) A beverage dispenser; or (f) A single-serve coffee brewer. (45) “Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland. (46) Mobile Food Service Facility. (a) “Mobile food service facility” means a food service facility that is a mechanically, electrically, manually, or otherwise propelled vehicle operating on land or water that moves as part of its routine operation to: (i) Change location for sales; (ii) Obtain food and other supplies; (iii) Fill potable water supply holding tanks; (iv) Empty wastewater holding tanks; or (v) Provide for the cleaning and sanitization of equipment and utensils. (b) “Mobile food service facility” does not include a food service facility that is able to be moved but does not move routinely for a purpose set forth in §B(46)(a) of this regulation. (46-1) “Mobile reciprocity license” means a license issued to a mobile food service facility that: (a) Is operating in the jurisdiction; (b) Is operating within 90 miles of its base of operations; and (c) Holds a valid license from the county of origin. (47) “Non-potentially hazardous food” means food named or described in §B(55)(c) of this regulation. (48) “On-farm food service facility” means a temporary food service facility that: (a) Is located on a farm; (b) Serves only those foods approved by the Department, based on a: (i) Review of the facility, equipment, and processing hazards; and (ii) Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and (c) Operates during a period of time of not more than 30 consecutive days with up to two renewals in a 1-year period. (49) “Package” means a bottle, can, carton, bag, or wrapped container. (50) “Packer” means a person who places shell eggs in the original case, carton, or container that is used to hold eggs for: (a) Distribution; or (b) Sale to a consumer. (51) “Person” has the meaning stated in Health-General Article, §§1-101 and 21-101, including: (a) An operator of a facility that is owned by the State or local unit of government; or (b) A State or local unit of government if the State or local unit of government is the operator of the facility. (52) “Person-in-charge” means: (a) The licensee; or (b) Another person responsible for the operation of a food service facility. (53) “pH” means the symbol for the negative logarithm of the hydrogen ion concentration in gram equivalents per liter of solution where: (a) pH values from 0 to 7 indicate acidity; (b) pH values from 7 to14 indicate alkalinity; and (c) The pH value for pure distilled water, regarded as neutral, is 7. (54) “Portable” means that equipment: (a) Can be easily moved because the equipment is: (i) Small in size and weighs 80 pounds or less; (ii) Mounted on casters, gliders, or rollers; or (iii) Provided with a mechanical means of safely tilting for cleaning; and (b) Has one of the following: (i) No utility connection; (ii) A utility connection that disconnects quickly; or (iii) A flexible utility connection line long enough to permit the equipment to be moved for thorough cleaning. (55) Potentially Hazardous Food. (a) “Potentially hazardous food” means a natural or synthetic food that requires temperature control because the food is in a form capable of supporting: (i) The rapid and progressive growth of infectious or toxigenic microorganisms; (ii) The growth and toxin production of Clostridium botulinum; or (iii) In raw shell eggs, the growth of Salmonella Enteritidis. (b) “Potentially hazardous food” includes: (i) A food of animal origin that is raw or heat-treated; (ii) A food of plant origin that is heat-treated; (iii) Raw seed sprouts; (iv) Cut melons; (v) Cut raw tomatoes; (vi) Garlic and oil mixtures that support growth as specified in §B(55)(a)(i) and (ii) of this regulation; and (vii) Cut leafy greens. (c) “Potentially hazardous food” does not include a: (i) Hard-boiled shell egg that has been air-cooled with the shell intact; (ii) Food with an aw value of 0.85 or less; (iii) Food with a pH level of 4.6 or below when measured at 75°F; (iv) Commercially sterile food in a hermetically sealed container; or (v) Food for which laboratory evidence demonstrates that the rapid and progressive growth of infectious and toxigenic microorganisms or the growth of Salmonella Enteritidis in eggs or Clostridium botulinum cannot occur, such as a food that has an aw or a pH that is above the levels specified in §B(55)(c)(ii)and(iii) of this regulation or that may contain a preservative, other barrier to the growth of microorganisms, or a combination of barriers that inhibit the growth of microorganisms. (56) “Poultry” means a: (a) Domesticated bird whether live or dead including a: (i) Chicken; (ii) Turkey; (iii) Duck; (iv) Goose; (v) Guinea; (vi) Ratite; or (vii) Squab; and (b) Migratory waterfowl or game bird whether live or dead, including a: (i) Pheasant; (ii) Partridge; (iii) Quail; or (iv) Grouse. (57) “Premises” means the physical food service facility and the contiguous land or property under the control of the operator or the licensee. (58) “Principal display panel” means the part of a container that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. (59) “Priority assessment” means an evaluation of risk in a food service facility using the parameters established by the Department in Regulation .33C of this chapter. (60) Public Event. (a) “Public event” means an event or festival that is a planned gathering that is: (i) Open to the public; and (ii) Regulated by the State or local jurisdiction in which the planned gathering takes place. (b) “Public event” includes an event or festival: (i) Attended by individuals from the general public whether or not a fee is charged; or (ii) Advertised with fliers, banners, newspaper articles, radio or television announcements, or on an Internet website as being open to the public. (c) “Public event” does not include a: (i) Private party; (ii) An event restricted to organization members; or (iii) Another event that restricts the general public from attending. (61) “Raw agricultural product” means a whole, unprocessed agricultural product supplied directly from the farm on which it was produced, including: (a) Grains; (b) Flowers; (c) Herbs; (d) Nuts; (e) Fruits; (f) Vegetables; and (g) Honey. (62) Ready-to-Eat Food. (a) “Ready-to-eat food” means food in a form that is edible without washing, cooking, or additional preparation by the food service facility or the consumer. (b) “Ready-to-eat food” includes: (i) Potentially hazardous food that is cooked to the temperature and time required for a specific food as set forth in Regulation .10 of this chapter; (ii) Raw fruits and vegetables that are washed and cut; (iii) Whole, raw fruits and vegetables that are presented for consumption without need for further washing, such as at a buffet; and (iv) A food presented for consumption for which further washing or cooking is not required and from which rinds, peels, husks, or shells are removed. (62-1) “Reconditioned” means reprocessing a food using an approved method that results in a food that is safe, wholesome, and free from contamination. (63) “Reconstituted” means water or other liquid has been restored to a food that was previously dehydrated. (64) Reduced Oxygen Packaged. (a) “Reduced oxygen packaged” means that a food was packaged so that the amount of oxygen in the package is below that found in the surrounding atmosphere due to the: (i) Mechanical evacuation of oxygen; (ii) Displacement of oxygen with one or more gases; or (iii) Reduction of the oxygen content by other means. (b) “Reduced oxygen packaged” includes food that is: (i) Vacuum packaged; (ii) Modified atmosphere packaged; and (iii) Controlled atmosphere packaged. (65) “Refrigerated food” means a food that: (a) Is not shelf stable; (b) Must be refrigerated to: (i) Retard the growth of spoilage or pathogenic microorganisms; and (ii) Prevent the production of microbial toxins; or (c) Is labeled by the manufacturer with a statement indicating that the product is to be kept refrigerated. (66) “Registration” means the process by which the Maryland Department of Agriculture grants the authority to a packer within the State to provide shell eggs for human consumption. (67) “Registration number” means the number that the Maryland Department of Agriculture assigns a packer. (68) “Retail food manufacturing” means the manufacturing of food in a food service facility for wholesale distribution. (68-1) Retail Food Store. (a) “Retail food store” means a licensed food service facility that sells prepackaged food items either fresh, refrigerated, frozen, or shelf-stable. (b) “Retail food store” includes a grocery store, convenience store, retail market, retail bakery, or food cooperative. (c) “Retail food store” does not include a restaurant, mobile food service facility, coffee shop, cafeteria, short order café, luncheonette, tavern sandwich shop, produce stand that only offers whole, uncut fresh fruits and vegetables, or establishment that offers only pre-packaged non-potentially hazardous foods. (69) “Sanitization” means a heat or chemical treatment on cleaned food contact surfaces that is sufficient to yield a 99.999 percent reduction of the number of representative disease microorganisms of public health significance. (70) “Seasonal farmer’s market producer sampling food service facility” means a facility that: (a) Serves only foods that are prepared and offered as samples by a producer of a farm product at a farmer’s market or a public event, such as: (i) Farm products as specified in §B(30)(a) of this regulation; or (ii) Farm products that have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture; (b) Serves food only produced by the licensee; (c) Serves only those foods approved by the Department, based on a: (i) Review of the facility, equipment, and processing hazards; and (ii) Determination that these foods can be prepared safely and in a manner that conforms to applicable laws and regulations; and (d) Operates during a period of time of not more than a 1-year period from the date of issuance or renewal of the license. (71) “Secretary” means the Secretary of Health or the Secretary's designee. (72) “Semi-permanent food service facility” means a facility that: (a) Is built at a location other than where it operates; (b) Is transported as a complete unit that does not require a building permit to install on the location at which it operates; (c) Has no indoor seating for patrons; (d) When serving cooked food, serves only foods cooked for immediate service; and (e) Is not a mobile food service facility as specified in §B(46) of this regulation. (73) “Service animal” has the meaning stated in Human Services Article, §7-701, Annotated Code of Maryland. (74) “Shell eggs” means raw eggs produced by chickens for human consumption. (75) “Shellfish” means all species of: (a) Oysters, clams, or mussels, whether: (i) Shucked or in the shell; (ii) Raw, including post-harvest processed; (iii) Frozen or unfrozen; and (iv) Whole or in part; and (b) Scallops in any form, except when the final product is the adductor muscle only. (76) Single Service Article. (a) “Single service article” means an article designed, fabricated, and intended for one-time consumer use. (b) “Single service article” includes a: (i) Utensil; (ii) Cup; (iii) Plate; (iv) Stirrer; (v) Napkin; (vi) Straw; (vii) Toothpick; (viii) Food container; (ix) Place mat; (x) Food package; or (xi) Similar item. (77) Single Use Article. (a) “Single use article” means an article intended by the manufacturer for one-time use by the preparer of the food. (b) “Single use article” includes a: (i) Bulk food container; (ii) Utensil; (iii) Formed aluminum pie pan; (iv) Jar; (v) Plastic bucket; or (vi) Similar item. (78) Special Food Service Facility. (a) “Special food service facility” means a food service facility for which the Department provides exceptions to certain regulations because of the nature of one or more of the following: (i) Design and operation of the facility; (ii) Food preparation or service methods; or (iii) Limited length of time that the facility operates in association with special events. (b) “Special food service facility” includes: (i) A bed and breakfast that serves hot meals; (ii) A mobile unit; (iii) A temporary food service facility; (iv) A semi-permanent food service facility; (v) An on-farm food service facility; or (vi) A seasonal farmer’s market producer sampling food service facility. (79) Tableware. (a) “Tableware” means multi-use eating, drinking, and serving utensils. (b) “Tableware” includes: (i) Knives; (ii) Forks; (iii) Spoons; (iv) Bowls; (v) Cups; (vi) Serving dishes; (vii) Tumblers; and (viii) Plates. (80) “Temporary food service facility” means a food service facility that operates at a fixed location for up to 30 consecutive days in conjunction with a: (a) Fair; (b) Carnival; (c) Public exhibition; (d) Construction project; (e) Recreational facility; (f) Fundraising event; or (g) Similar gathering. (81) “Time-only” means using time instead of time in conjunction with temperature as the sole means of food protection for a potentially hazardous food. (82) “Undercooked” means a potentially hazardous food that is not cooked to the minimum internal temperature and for the specified holding time specified in Regulation .10A of this chapter. (83) “Utensil” means tableware or a food-contact implement used in the storage, preparation, dispensing, or serving of food. (84) “Vending machine” means a self-service device that dispenses either packaged or unpackaged food. (85) “Warewashing” means the cleaning and sanitizing of food-contact surfaces of equipment or utensils. (86) Whole Muscle, Intact Beefsteak. (a) “Whole muscle, intact beefsteak” means a beefsteak cut from whole muscle beef that has not been penetrated in a way that may allow infectious or toxigenic microorganisms to be introduced into the interior of the meat. (b) “Whole-muscle, intact beefsteak” does not include meat that has been: (i) Injected; (ii) Mechanically tenderized; (iii) Reconstructed; or (iv) Scored. #### Regulation .03 Incorporation by Reference. *COMAR 10.15.03.03* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) 21 CFR, as amended; (2) 9 CFR, as amended; and (3) 21 U.S.C. §343, as amended. #### Regulation .04 Food Supplies and Sources: General. *COMAR 10.15.03.04* The person-in-charge shall ensure that: A. Food served to the public is: (1) Wholesome and free from contamination; (2) Not adulterated; (3) Safe for human consumption; (4) Obtained from an approved source; and (5) If in packaged form, labeled in accordance with: (a) COMAR 10.15.01; (b) COMAR 10.15.02; (c) COMAR 10.15.04; and (d) This chapter; B. Eggs and egg products comply with Regulation .05 of this chapter; C. Milk and milk products are not sold or served unless they are produced, processed, stored, transported, and distributed in accordance with COMAR 10.15.06 and COMAR 10.15.09, including: (1) Fluid milk; (2) Other fluid dairy products; (3) Manufactured milk products; and (4) Reconstituted dry milk or dry milk products used only for: (a) Instant desserts; (b) Whipped products; and (c) Cooking and baking purposes; D. Frozen desserts including ice cream, soft frozen desserts, ice milk, sherbets, ices, gelato, and frozen dessert mix are manufactured and sold in accordance with COMAR 10.15.05; E. Shellfish: (1) Are obtained from an approved source; (2) Are from a firm listed in the “Interstate Certified Shellfish Shippers List”; (3) Are processed, handled, packed, labeled, and identified in accordance with COMAR 10.15.07; (4) Containers are identified with a tag or label as set forth in COMAR 10.15.07; and (5) Tags are maintained on the premises for 90 calendar days after a container of shellfish is emptied to identify readily the source of the shellfish, by: (a) Recording the date on the tag or label when the last shellfish from the container is sold or served; (b) Using an approved record keeping system that: (i) Keeps the tags or labels in chronological order; and (ii) Preserves source identification if tags or labels are removed from the container; and (c) Ensuring that shellfish from one tagged or labeled container is not mixed with shellfish from another container if the tags or labels are removed from the container. F. Crab meat is processed, handled, and packed in accordance with COMAR 10.15.02; G. Seafood is processed, handled, and packed in accordance with COMAR 10.15.10; H. Meat and poultry have been inspected for wholesomeness by the approving authority; and I. Ice is: (1) Made: (a) From a potable water supply; (b) In an ice-making machine that: (i) Meets the standards in Regulation .15 of this chapter; and (ii) Is located, installed, operated, and maintained to prevent contamination; (2) If not manufactured on site, obtained from an approved source; (3) Handled, transported, and stored in a manner that precludes contamination; and (4) Not reused. #### Regulation .05 Eggs and Egg Products. *COMAR 10.15.03.05* A. The person-in-charge shall ensure that: (1) Only clean, whole Grade A or higher grade eggs with shell intact and without cracks, or pasteurized eggs or egg products, are used; (2) An invoice or other equivalent record is obtained from the supplier for each delivery of shell eggs; (3) The invoice or equivalent record required in §A(2) of this regulation contains the following information written in English: (a) Name and address of the seller and buyer; (b) Date of delivery; (c) Grade and size of eggs delivered; and (d) Quantity of eggs sold in number by grade and size; (4) When loose eggs are distributed, offered for sale, or sold directly to a consumer in Maryland: (a) A daily record is maintained that shows the lot designation of the shell eggs for each packer; (b) A placard is displayed that: (i) Is legible and printed in block letters not less than 3/8 inch in height; (ii) Is a minimum size of 4-1/4 inches by 6 inches; (iii) Plainly and conspicuously displays the eggs' grade term, size (weight), and lot designation; and (iv) Is placed on or near the eggs; and (c) Egg cartons are labeled in accordance with §A(9), (10), and (12) of this regulation; (5) All egg invoices, daily records, or other equivalent records are kept on file for a minimum of 90 days; (6) Upon request, the approving authority is granted access to copy and verify, at any reasonable time, records relating to the sale and purchase of shell eggs; (7) Except as provided in Regulation .10 of this chapter, only pasteurized eggs and egg products are used when serving eggs or foods prepared with eggs that have not been heated adequately to kill Salmonella Enteritidis; (8) All shell eggs accepted for delivery, used, or provided to the consumer are: (a) Produced by flocks that are certified to be in compliance with COMAR 15.11.11; (b) Supplied by a registered packer as provided in COMAR 15.04.01; and (c) Pasteurized or otherwise heat-treated to kill Salmonella Enteriditis if Salmonella Enteriditis is isolated from a flock in Maryland as determined by testing procedures contained in COMAR 15.11.11; (9) All egg cartons of shell eggs accepted for delivery, used, or provided to the consumer are labeled on the principal display or information panel with: (a) Legible stamping in permanent ink; (b) The following information at a minimum type size of 1/16 of an inch: (i) The packer's or distributor's name and address; (ii) The packer's registration number; (iii) The lot designation of the eggs; and (iv) A safe handling statement with the words “safe handling instructions” in bold capital letters and the statement “To prevent illness from bacteria: keep eggs refrigerated, cook eggs until yolks are firm, and cook foods containing eggs thoroughly.” set off in a box by hairlines; (c) The following information at a minimum type size of 1/4 of an inch: (i) The identity of the product as eggs; and (ii) The word “grade” and the grade term (AA or A) and size (weight) of the eggs; and (d) The net quantity of eggs in weight or numerical count in at least the minimum type size permitted based on the space available for labeling as set forth in §B of this regulation, with the minimum type size measurement determined by: (i) The height of type of printing by measuring the height of the lower case letter “o” or its equivalent when mixed upper and lower case letters are used; or (ii) The height of the upper case letters when only upper case letters are used; (10) If the safe handling statement does not appear on the principal display panel or the front information panel, a separate statement that eggs be kept refrigerated is printed on either the principal display panel or the front of the information panel; (11) The same information in at least the same minimum type size that is required on an egg carton is printed on the top of an egg case or any side of an egg case; and (12) The grade term and size (weight) on an egg carton is not abbreviated. B. Table 1. #### Regulation .06 Food Protection During Storage, Service, and Transport. *COMAR 10.15.03.06* The person-in-charge shall ensure that: A. At all times: (1) Food is: (a) Not adulterated; and (b) Protected from contamination during storage, preparation, display, service, and transportation; (2) The internal temperature of a food is maintained according to the requirements of this chapter to preclude the growth of pathogenic bacteria and other microorganisms that could cause spoilage; (3) Except during necessary periods of preparation and service, a potentially hazardous food is refrigerated or held hot as set forth in §B(7) of this regulation; B. When storing and holding food: (1) Facilities used for hot or cold potentially hazardous food are provided a temperature-measuring device that is: (a) Graduated and accurate to plus or minus 2°F; (b) Calibrated annually or more frequently; (c) Located in the: (i) Coldest area of equipment where hot foods are stored; and (ii) Warmest area of equipment where cold foods are stored; and (d) Easily readable; (2) Except for metal beverage containers and cased food packaged in cans, glass, or other waterproof containers stored as provided in §B(3) of this regulation, containers of food are stored: (a) Off the floor; (b) 18 inches above the floor or higher if food is exposed; (c) On clean racks, dollies, or other clean surfaces; and (d) In a manner that will protect from splash and other contamination; (3) When metal beverage containers and cased food in cans, glass, or other waterproof containers are stored on the floor: (a) The floor is maintained in a clean and sanitary condition; (b) The storage: (i) Is temporary such as for floor displays; (ii) Does not interfere with the flow of food or personnel; and (iii) Does not afford harborage for rodents or insects; (4) In refrigeration units, the food is placed to permit free circulation of cold air; (5) Except where food packaging prevents the entry of water, packaged food is not stored in contact with water or un-drained ice; (6) Food is not stored in locker rooms, toilet rooms, dressing rooms, garbage rooms, or mechanical rooms; (7) Except as provided in §B(8)—(13) of this regulation, the internal temperature of a potentially hazardous food is kept at 41°F or less or 135°F or greater; (8) If pasteurized crab meat, the crab meat’s internal temperature is maintained at 41°F or less; (9) If potentially hazardous reduced oxygen packaged products, the reduced oxygen packaged food's internal temperature is maintained at: (a) 38°F or less if refrigeration is the only barrier to control the growth of Clostridium botulinum; or (b) At a lower temperature if a lower temperature is specified by the food manufacturer; (10) If shell eggs and shellfish, the eggs and shellfish are stored, displayed, and transported under refrigeration at an ambient temperature of 45°F or less; (11) Except for the service of foods such as ice cream and frozen desserts, frozen food is received and stored frozen; (12) If a whole roast cooked and cooled in accordance with Regulations .10 and .11 of this chapter, the roast is held at an internal temperature of 130°F or above; and (13) Using holding temperatures and times other than those specified in this section, the holding temperatures and times are: (a) Scientifically proven to be effective in preventing the growth of foodborne pathogens; (b) Incorporated into an HACCP plan; and (c) Submitted to and approved by the Department based on a review that indicates compliance with §B(13)(a) and (b) of this regulation; C. While displaying and serving food: (1) Except as provided in §C(3) of this regulation, a potentially hazardous cold food that is placed on display is: (a) Pre-chilled to an internal temperature of 41°F or below; (b) Rapidly re-chilled to an internal temperature of 41ºF or below if the food has exceeded 41ºF for a verifiable period of not more than 4 hours; or (c) Discarded if: (i) The food has exceeded 41°F or more for more than 4 hours; or (ii) The time the food has been out of temperature is not verifiable; (2) Except as provided in §§B(12) and (13) and C(3) of this regulation, a potentially hazardous hot food that is placed on display is: (a) Cooked according to Regulation .10 of this chapter; (b) Rapidly re-heated to an internal temperature of 165ºF or above if the food was below 135ºF for a verifiable period of not more than 4 hours; and (c) Discarded if: (i) The food was below 135°F for more than 4 hours; or (ii) The time the food has been out of temperature is not verifiable; (3) A potentially hazardous bakery product that is stored at room temperature: (a) Is manufactured, packaged, and labeled with a sell-by date only in an approved food processing plant meeting the requirements set forth in COMAR 10.15.04; (b) Remains in the original package until sold to a consumer; and (c) Is not offered for human consumption following expiration of the sell-by date; (4) Except as provided in §C(5) of this regulation, raw unpackaged food of animal origin is not offered for consumer self-service; (5) Raw unpackaged foods of animal origin offered for consumer self-service are offered only: (a) At buffets or salad bars that serve foods of animal origin such as sushi or raw shellfish; (b) When the foods of animal origin are ready-to-cook individual portions for immediate cooking and consumption on premises, such as for Mongolian barbecue; or (c) Frozen if shell-on shrimp and lobster; (6) When uncovered food is placed on display in food operations, including buffets and cafeterias, the ready-to-eat food is protected by: (a) Physical guards; (b) Separation from potential contaminants; or (c) Other effective methods acceptable to the approving authority; (7) During pauses in food preparation or dispensing, utensils such as scoops, spoons, and dippers are stored: (a) In a running water dipper well that provides a volume of fresh potable water sufficient to maintain the utensil in a sanitary condition; (b) In hot water that is maintained at 135°F or above; (c) With the handles above the top of the food in an open container; (d) On a clean portion of the food preparation or cooking equipment, which has been cleaned and sanitized as set forth in Regulation .16 of this chapter; or (e) In a clean, protected location if the utensils are used with a food that is not potentially hazardous; (8) Sugar, condiments, seasonings, and dressings are provided for self-service in individual packages or dispensed by methods that protect the food; (9) Except for packaged non-potentially hazardous foods with the wrapping intact, portions of food once served to a customer are not served again; and (10) Except for drinking cups reused by self-service consumers in a manner to prevent cross-contamination, employees and self-service customers do not reuse soiled tableware, including single service articles to: (a) Provide second portions or refills; or (b) Obtain additional food from display and serving equipment; D. During the transportation of food: (1) Except as provided in §B(8)—(13) of this regulation, the internal temperature of a potentially hazardous food is maintained at 41°F or below or 135°F or above; (2) From a food service facility to another location, the requirements set forth in §A(2) of this regulation are met; (3) Frozen food is maintained frozen; and (4) Food is in covered containers or completely wrapped or packaged to protect against contamination; and E. During the preparation, storage, or service of food: (1) Unsafe or adulterated food is discarded or reconditioned according to an approved procedure by the approving authority; (2) Food that is not from an approved source as specified under Regulation .04 of this chapter is discarded; (3) Ready-to-eat food that may have been contaminated by an employee who has been restricted or excluded as specified under Regulation .14A or B of this chapter is discarded; and (4) Food shall be discarded if it is contaminated by employees, consumers, or other persons through: (a) Contact with their hands; (b) Bodily discharges, such as nasal or oral discharges; or (c) Other means. #### Regulation .07 Food Protection During Outdoor Preparation and Service. *COMAR 10.15.03.07* The person-in-charge shall ensure that: A. During the use of outdoor cooking equipment, such as a barbeque grill, at a food service facility: (1) Equipment: (a) Is used only at the food service facility for service to patrons; (b) Is located: (i) On an impermeable surface; (ii) In close proximity to the food preparation area of the food service facility; and (iii) Away from parking areas, dumpsters, and patron entrances; and (c) Meets the requirements set forth in Regulation .15 of this chapter; (2) Food is: (a) Prepared for outdoor cooking inside the food service facility; and (b) Protected from contamination during cooking and service; and B. When preparing beverages outdoors: (1) Overhead protection is provided; (2) Protection from contamination during storage is provided for ingredients, including: (a) Ice; (b) Drink mixes; and (c) Condiments; (3) Containers are protected from contamination during storage; and (4) Other than when only beer, wine, or soda is offered, a hand washing sink is provided in accordance with Regulation .18K and L of this chapter. #### Regulation .08 Use of Time-Only with Potentially Hazardous Food. *COMAR 10.15.03.08* A. The approving authority may approve the use of time-only, rather than time in conjunction with temperature, for food protection as set forth in §B of this regulation. B. The person-in-charge shall ensure that: (1) Before using time-only while holding or preparing a potentially hazardous food: (a) A written request is submitted to and approved by the approving authority for a specific food under specific conditions of preparation and service that includes: (i) A record-keeping procedure that can verify safety intervention steps; and (ii) Procedures for marking or otherwise identifying the food with the time by which it is to be either used or discarded; and (b) The procedures for time-only are included in the food service facility's HACCP plan as a critical control point; (2) Except as otherwise approved by the approving authority, the maximum time limit under time-only control is 4 hours for a: (a) Raw, working supply of potentially hazardous food during preparation, after which time the food is cooked or discarded; and (b) Ready-to-eat potentially hazardous food held for immediate consumption, after which time the food not served is discarded; (3) Food has an initial temperature of: (a) 41°F or less upon removal from refrigeration; or (b) 135°F or more upon removal from cooking equipment; and (4) Food that has been protected using time-only control is not served in a health care facility. #### Regulation .09 Food Preparation — Temperature and Cross-Contamination Control. *COMAR 10.15.03.09* The person-in-charge shall ensure that: A. Food temperature measuring devices are: (1) Used to monitor the temperature of potentially hazardous foods; (2) Graduated and accurate within plus or minus 2°F; (3) Calibrated annually or more frequently; and (4) Cleaned and sanitized between uses in different foods to prevent cross-contamination; B. The storage, thawing, cooking, cooling, reheating, and holding of a food: (1) Are safe; and (2) Comply with this chapter; C. When a recipe in which more than one egg is broken and the eggs are combined and not prepared for immediate service: (1) The mixture is stored under refrigeration at all times before cooking; (2) The process is included in the food service facility's HACCP plan as a critical control point; and (3) The mixture containing eggs is cooked to a minimum internal temperature of 155°F for 15 seconds; D. Potentially hazardous food is thawed: (1) In refrigerated units so that the temperature of the food does not exceed 41°F; (2) Under potable running water that is at or below 70°F with sufficient force to agitate and float off loose particles; (3) In a microwave oven only when the food will be immediately cooked in the microwave oven or immediately transferred to conventional cooking facilities as part of a continuous cooking process; (4) If a potentially hazardous reduced oxygen packaged food: (a) In the food’s airtight package at or below 41°F; (b) At a lower temperature if specified by the manufacturer; or (c) If fish or seafood, completely removed from the reduced oxygen environment or package prior to thawing; (5) As part of a conventional cooking process; or (6) By another method acceptable to the approving authority that has been scientifically proven to the approving authority to prevent the bacteriological, physical, or chemical contamination of food; E. Employees prevent contact of exposed, ready-to-eat food with their bare hands by using: (1) Gloves as specified under Regulation .14J of this chapter; (2) Utensils such as: (a) Tongs; (b) Spatulas; (c) Deli tissue; or (d) Automatic dispensing equipment; and F. Cross-contamination is prevented by: (1) Not allowing contact between ready-to-eat and raw foods; (2) Storing and holding food so that: (a) Ready-to-eat food is located above or otherwise segregated from raw food; and (b) A food is protected from plumbing leaks and condensate drippage; (3) Using separate utensils and work surfaces for ready-to-eat food and foods requiring further preparation; (4) Cleaning and sanitizing utensils and work surfaces between uses; (5) Excluding sick workers from food handling in accordance with Regulation .14A and B of this chapter; and (6) Washing raw fruits and vegetables thoroughly to remove soil and other contaminants before cutting, cooking, or serving, with: (a) Water; or (b) Chemicals intended specifically for washing or peeling whole fruits and vegetables as specified in 21 CFR §173.315. #### Regulation .10 Food Preparation — Cooking. *COMAR 10.15.03.10* A. Except as provided in §§B—D of this regulation, the person-in-charge shall ensure that potentially hazardous food is cooked to the minimum internal temperature and for the specified holding time as follows: (1) Chart 1. Summary of Minimum Cooking and Reheating Food Temperatures and Holding Times. (2) A minimum internal temperature of 145°F for 15 seconds for: (a) Shell eggs prepared for immediate service; (b) Fish; (c) Meat; and (d) All other potentially hazardous food not specified in §A(3)—(7) of this regulation; (3) A minimum internal temperature of 155°F for 15 seconds or as specified in §A(1) of this regulation for: (a) Shell eggs not prepared for immediate service; (b) Ratites; (c) Comminuted fish and meats; (d) Game animals commercially raised for food; and (e) Injected meats; (4) A minimum internal temperature of 130°F for 112 minutes or as specified in §A(1) of this chapter for: (a) Whole or corned beef; and (b) Pork and cured pork roasts; (5) A minimum internal temperature of 165°F for 15 seconds for: (a) Poultry; (b) Stuffed meat, pasta, or poultry; (c) Exotic bird species; (d) Wild game animals; and (e) Stuffing containing fish, meat, or poultry; (6) A minimum internal temperature of 165°F and held for 2 minutes after removing from the oven for raw animal foods that are cooked in a microwave oven; and (7) A minimum internal temperature of 135°F for fruits and vegetables cooked for hot holding. B. The Department may approve cooking times and temperatures other than those specified in §A of this regulation, if the cooking times and temperatures are scientifically proven to the Department to be as effective in killing foodborne pathogens as those specified in §A of this regulation. C. The person-in-charge may serve a consumer: (1) Undercooked seared beefsteak when: (a) Only whole muscle, intact beefsteak, is prepared; (b) The meat is seared continuously on both top and bottom utilizing a heating environment that: (i) Imparts a temperature at the surface of the intact steak of at least 145°F for 15 seconds; and (ii) Achieves a cooked color change on all external surfaces; and (c) A HACCP plan specifically developed for undercooked seared beefsteak is submitted and approved by the approving authority; and (2) A food that is cooked, cooled, and then refrigerated in accordance with this chapter, such as roast beef for a sandwich, cold or warmed to any desired temperature for immediate consumption. D. A health care facility may not serve a raw or undercooked animal food. E. Repealed. F. The person-in-charge shall ensure that a consumer advisory is issued when an animal food, such as beef, eggs, fish, lamb, pork, poultry, or shellfish, is served raw or undercooked by: (1) Providing a written notification on: (a) A menu or brochure; (b) A deli case or menu board; (c) A label statement; (d) A table tent or placard; or (e) Another written means that is visible and legible to the consumer; (2) Identifying food items on the items set forth in §F(1) of this regulation with an asterisk to a footnote that states the item: (a) Is served raw; (b) Is served undercooked; (c) May be cooked to order upon specific consumer request; or (d) Contains raw or undercooked ingredients; and (3) Providing this written statement: “Consuming raw or undercooked animal foods may increase your risk of contracting a foodborne illness, especially if you have certain medical conditions.” #### Regulation .11 Food Preparation — Cooling and Reheating of Potentially Hazardous Foods. *COMAR 10.15.03.11* The person-in-charge shall ensure that: A. A potentially hazardous cooked food’s internal temperature is cooled from 135°F to 70°F within 2 hours and from 70°F to 41°F or less within an additional 4 hours; B. A potentially hazardous food for cold service, such as a reconstituted food, salad, or canned meat, is cooled to an internal temperature of 41°F within 4 hours; C. Cooling of potentially hazardous food is accomplished using one or a combination of the following methods: (1) Refrigerate in shallow pans with food not over 3 inches deep; (2) Reduce food mass by separating foods into smaller or thinner portions; (3) Use rapid cooling equipment; (4) Use ice water baths combined with frequent stirring; (5) Use containers that facilitate heat transfer; (6) Add ice made from potable water as an ingredient; (7) Refrigerate loosely covered or allow the food to remain uncovered until cooled if the food is protected from overhead contamination; or (8) Another effective method acceptable to the approving authority based on applicable state and local laws, regulations, and ordinances; and D. Potentially hazardous food is reheated: (1) Within 2 hours to a minimum internal temperature of 165°F for 15 seconds for food that is cooked, cooled, and refrigerated before being placed into hot food holding equipment; (2) Within 2 hours to a minimum internal temperature of 135°F for ready-to-eat food taken from a commercially processed, hermetically sealed container or from an intact package from a food processing plant that is inspected by a food regulatory authority for hot holding; (3) Using the same time and temperature conditions specified in Regulation .10A of this chapter for initial cooking for remaining unsliced portions of roasts for hot holding; and (4) Within 2 hours or less, to a minimum internal temperature of 165°F for 15 seconds in a microwave oven for hot holding and then stirred, covered, and allowed to stand covered for 2 minutes after reheating. #### Regulation .12 Food Labeling. *COMAR 10.15.03.12* A. The person-in-charge shall ensure that: (1) Except as specified in §B of this regulation, each item of packaged food has a label containing the following information: (a) The common name of the food or a descriptive identity statement; (b) If made from two or more ingredients: (i) A list of ingredients in descending order of prominence by weight; and (ii) A declaration of artificial color or flavor and chemical preservatives; (c) An accurate declaration of the quantity of the package contents by weight in both metric and English units; (d) The name and place of business of the manufacturer, packer, or distributor; (e) Except as exempted in 21 U.S.C. §343(q)(3)—(5), the nutrition labeling specified in 21 CFR Part 101 and 9 CFR Part 317; and (f) The name of the food source for each major food allergen that is contained in the food unless the food source is already part of the common or usual name of the respective ingredient; (2) The use of canthaxanthin as a color additive in salmonid fish is disclosed by written means, such as a counter card; (3) Bulk food available for consumer self-dispensing is prominently labeled with the following information in plain view of the consumer: (a) The manufacturer's label that was provided with the food; or (b) A card, sign, or other method of notification that includes the information specified in §A(1)(a), (b), and (f) of this regulation. B. A food service facility may offer for sale bulk, unpackaged foods such as bakery products and unpackaged foods that are portioned to consumer specification without a label if: (1) A health, nutrient, or other claim relating to the unpackaged food is not made on a card or sign; and (2) The food is manufactured or prepared on the premises of the food service facility or at another food service facility owned by the same person. #### Regulation .13 Food Protection from Poisonous or Toxic Materials. *COMAR 10.15.03.13* The person-in-charge shall ensure that: A. Except for packaged poisonous or toxic products offered in their unopened original containers for retail sale, only poisonous or toxic materials needed to maintain sanitary conditions and to sanitize equipment and utensils are located in a food or food utensil area; B. A container of a poisonous or toxic material is: (1) Kept in the original bulk container before use; (2) Prominently and distinctively marked or labeled for easy identification; and (3) Used according to the manufacturer's directions; C. When not in use, poisonous or toxic materials are stored in a: (1) Cabinet used for no other purpose; or (2) Room not used for food storage, food preparation, or equipment and utensil washing or storage; D. A bactericide, cleaning compound, or other compound intended for use on food-contact surfaces is not: (1) Stored in the same cabinet with an insecticide, rodenticide, or other poisonous or toxic material; or (2) Used or stored in a way that will leave a toxic residue on food-contact surfaces; E. A poisonous or toxic material is not used or stored in a way that will: (1) Contaminate: (a) Food; or (b) Food equipment; or (2) Constitute a potential hazard to: (a) Employees; or (b) Customers; F. A medication is not stored in a food storage, preparation, processing, or service area; G. First aid supplies are stored in a way that prevents contamination of: (1) Food; or (2) Food-contact surfaces; and H. A container previously used to store poisonous or toxic materials is not used to store, transport, or dispense: (1) Food; or (2) Items that will come into contact with food. #### Regulation .14 Personnel Health and Sanitation. *COMAR 10.15.03.14* The person-in-charge shall ensure that: A. As set forth in COMAR 10.06.01.06E, a food handler does not serve or handle food intended for public consumption if the food handler: (1) Has any of the following diseases: (a) Diarrhea caused by Entamoeba histolytica; (b) Cholera; (c) Disease causing diarrhea, unless physician-certified as noninfectious; (d) E. coli O157:H7; (e) Hepatitis A; (f) Diarrhea caused by Salmonella; (g) Shigellosis; (h) Streptococcal infection caused by group A beta-hemolytic Streptococcus; or (i) Typhoid fever; or (2) Is a carrier of Salmonella Typhi; B. An employee experiencing persistent sneezing, coughing, or a runny nose that causes discharges from the eyes, nose, or mouth does not work with: (1) Exposed food; (2) Clean equipment, utensils, and linens; or (3) Unwrapped single service or single use articles; C. An employee who has a disease that may be transmissible through food reports the condition to the person-in-charge; D. The approving authority is notified when an employee of a food service facility is known to have or is suspected of having a disease that is transmissible by food; E. An employee washes hands and exposed arm areas thoroughly with soap and warm water: (1) Before handling: (a) Exposed foods; or (b) Food-contact surfaces; (2) Before starting work; (3) As often as required to remove soil and contamination; (4) After using toilet facilities; and (5) Before and between glove use; F. An employee washes hands, exposed portions of the arms, between the fingers, and underneath the fingernails: (1) With a cleaning compound; (2) At a hand washing facility that is equipped as specified in Regulation .18K and L of this chapter; and (3) By: (a) Vigorously rubbing together the surfaces of lathered hands and arms for at least 20 seconds; (b) Cleaning under the nails with a brush if needed; and (c) Thoroughly rinsing the hands and arms with clean water; G. An employee keeps hands clean while engaged in handling food and food-contact surfaces; H. An employee who handles exposed food and food-contact surfaces: (1) Keeps fingernails clean and neatly trimmed; (2) Unless wearing gloves that are in good repair, does not wear fingernail polish or artificial fingernails; (3) Except for a plain, smooth ring such as a wedding band, does not wear jewelry; (4) Wears outer garments that are clean; (5) Uses hairnets, caps, or other effective hair restraints in order to keep hair from contacting food and food-contact surfaces; (6) Maintains personal cleanliness; and (7) Except as provided in §L of this regulation, does not eat, drink, or use tobacco in any form while working; I. An employee does not use bare hands for handling ready-to-eat foods, as set forth in Regulation .09E of this chapter; J. An employee using gloves to protect exposed food: (1) Uses gloves only for one task; (2) Does not use the same gloves while working with ready-to-eat food and raw food; and (3) Discards used gloves when: (a) The gloves are damaged or soiled; (b) An interruption occurs in the operation; or (c) After 2 hours of continuous use; K. An employee receives training in proper food handling and sanitation as it relates to assigned duties; and L. When in a food preparation or utensil washing area, an employee: (1) Drinks only from a covered beverage container; and (2) Handles the container in a way that prevents contamination of: (a) The employee's hands; (b) Exposed food; (c) Clean equipment; (d) Utensils; (e) Linens; and (f) Unwrapped single service and single use articles. #### Regulation .15 Food Equipment and Utensils. *COMAR 10.15.03.15* A. The person-in-charge shall ensure that: (1) Except as provided in §§A(2) and (14) and B of this regulation, food equipment meets one or more of the following design standards: (a) National Sanitation Foundation (NSF) or equivalent sanitation certification from: (i) The Etlsemko division of Intertek Group PLC (Intertek ETL SEMKO); (ii) Canadian Standards Association (CSA); or (iii) Underwriters Laboratories (UL); (b) Baking Industry Sanitation Standards Committee; (c) National Automation Merchandizing Association; (d) International Association of Milk and Food Sanitarian's "3-A Sanitary Standards"; or (e) Another applicable published standard acceptable to the approving authority; (2) When design standards conflict with State laws, codes, or regulations, the State laws, codes, or regulations are followed; (3) Equipment and utensils are designed, constructed, and maintained to: (a) Accomplish the intended and required functions; (b) Protect food from internal and external contamination; (c) Be durable under normal conditions and operations; (d) Be resistant to: (i) Denting; (ii) Buckling; (iii) Pitting; (iv) Chipping; (v) Crazing; and (vi) Excessive wear; (e) Have non-food contact surfaces where exposed to splash, food debris, or other soils that are: (i) Smooth; (ii) Washable; and (iii) Readily accessible; (f) Withstand repeated scrubbing, scouring, corrosive action of food, cleansers, and sanitizing agents; and (g) Prevent harboring of soils, bacteria, or pests: (i) In or on the equipment; and (ii) Between the equipment and other equipment, floors, walls, or supports; (4) Materials used as food contact surfaces of equipment are: (a) Nontoxic; (b) Unable to contaminate or be absorbed by food under the conditions of use; (c) Non-porous and nonabsorbent; and (d) Except for the use of cast iron as a food contact material if the surface is to be heated, corrosion resistant; (5) Food contact surfaces of equipment and utensils are designed, constructed, and maintained to be: (a) Smooth; (b) Easily cleanable; (c) In good repair; (d) Free of difficult to clean internal corners and crevices; (e) Self-emptying or self-draining if an interior surface; (f) Visible or readily disassembled for inspection; and (g) Readily: (i) Accessible for manual cleaning without tools; or (ii) Disassembled with the use of simple tools kept available near the equipment; (6) Equipment designed for pressurized cleaning-in-place is designed, constructed, and maintained to: (a) Fully circulate cleaning and sanitizing solutions through a fixed system in which the solutions will contact all interior food contact surfaces; (b) Self-drain or otherwise completely evacuate all cleaning solutions; and (c) Effectively clean and sanitize all food contact surfaces without disassembly; (7) Cutting blocks, bakers tables, and similar wood food contact surfaces are made from: (a) Hard maple; or (b) Another material that is: (i) Nontoxic; (ii) Smooth; and (iii) Free of cracks, crevices, and open seams; (8) Lubricants used on bearings and gears of equipment are food-grade; (9) Except for equipment that is portable, equipment that is placed on tables or counters is: (a) Sealed in place; (b) Mounted on legs or feet at least 4 inches high; or (c) Installed to allow cleaning of the equipment and adjacent areas; (10) Floor-mounted equipment is: (a) Elevated: (i) At least 6 inches above the floor; and (ii) So that food contact surfaces are at least 18 inches above the floor; and (b) Placed so that there is sufficient space for cleaning between: (i) Adjoining units; and (ii) A unit and the adjacent walls; (11) The spaces between adjoining equipment are closed and sealed if exposed to seepage; (12) Aisles or working spaces between equipment and between equipment and walls are: (a) Unobstructed and of sufficient width to permit employees to perform duties without contaminating food or food-contact surfaces by clothing or personal contact; and (b) In a new facility or a facility that is remodeled, a minimum width of: (i) 3 feet where food preparation occurs on only one side of the aisle; (ii) 4 feet where food preparation occurs on both sides of the aisle and employees work back to back; (iii) 5 feet where food preparation occurs on both sides of the aisle, employees work back to back, and other employees must pass through the area; or (iv) Another width approved by the approving authority based on a review that indicates compliance with §A(12)(a) of this regulation; (13) Equipment is installed and located to limit the potential for cross-contamination of food; (14) When an existing piece of equipment ceases to operate: (a) Equipment intended for temporary use is: (i) Acceptable to the approving authority; and (ii) In compliance with §A(3)—(8) of this regulation; (b) Equipment is replaced: (i) With equipment that meets the requirements of this regulation; and (ii) Within 30 working days from the date the permanent replacement plan required in §A(14)(c) of this regulation is accepted by the approving authority; and (c) The approving authority is provided plans for permanent replacement of the failed unit within 10 working days after the failure of the unit; and (15) A vending machine containing potentially hazardous foods has an automatic control that prevents the machine from vending food: (a) If there is a power failure, mechanical failure, or other condition resulting in an internal machine temperature that cannot maintain food temperatures as specified in Regulation .06B(7) of this chapter; and (b) Until serviced and working properly. B. The approving authority may allow the use of equipment that meets §A(3)—(10) of this regulation but fails to comply with §A(1) of this regulation if a review indicates the equipment and its use are: (1) Not harmful to public health; and (2) Consistent with industry standards and practice. #### Regulation .16 Cleaning and Sanitizing Equipment and Utensils. *COMAR 10.15.03.16* The person-in-charge shall ensure that: A. Food contact surfaces of equipment and utensils are effectively cleaned and sanitized by: (1) Removing soil and food particles by one or more of the following: (a) Flushing; (b) Soaking; (c) Scraping; (2) Cleaning with a suitable commercial detergent; (3) Rinsing with potable water; and (4) Sanitizing, using: (a) Immersion in hot water of 170°F or higher temperature for at least 30 seconds; (b) Immersion in a chemical sanitizer that is proven to kill pathogens effectively: (i) In accordance with the manufacturer's label use instructions; or (ii) As set forth in §C(1) of this regulation; or (c) For equipment that is not sanitized by the methods set forth in §C(1) of this regulation: (i) Live steam from a hose, provided that the steam can be confined within the equipment; (ii) A rinse with boiling water; or (iii) A spray or swab with a chemical sanitizing solution of at least the minimum strength stated in §C(1) of this regulation; B. Cleaning and sanitization occur: (1) As often as needed to prevent food contamination; (2) After each use; (3) Between an interruption in food preparation greater than 4 hours; and (4) Except for food contact surfaces of equipment or utensils within holding units that are maintained at proper temperatures, after a continuous use of 4 hours; C. When sanitizer is used for the manual sanitization of food contact surfaces of equipment and utensils: (1) The minimum level of sanitizer provided is: (a) 50 parts per million chlorine with a minimum water temperature of 75°F and a minimum contact time of 7 seconds; (b) 12.5—25 parts per million iodine with a minimum water temperature of 75°F and a minimum contact time of 30 seconds; or (c) The concentration indicated on the manufacturer's label with a minimum contact time of 30 seconds for quaternary ammonium compound; and (2) A test kit or other device that accurately measures concentration of the sanitizer in parts per million is provided and used to check that the minimum level of sanitizer is accurate; D. When hot water is used as the sanitizing agent in manual operations, a graduated thermometer is provided that is: (1) Accurate within plus or minus 2°F; (2) Calibrated annually or more frequently; (3) Located near the sink; and (4) Used frequently to check water temperature; E. A three-compartment sink is: (1) Provided and used wherever warewashing is conducted manually; (2) Adequate in length, width, and depth to accommodate the largest equipment items and utensils; (3) Supplied with hot and cold running water at each sink compartment; and (4) If used for tasks other than warewashing, such as washing wiping cloths or produce or thawing food: (a) Is washed and sanitized before and after the sink is used for a different task; and (b) Does not contain an automatic chemical dispenser; F. Dish tables or integral drainboards are: (1) Of adequate size for proper handling of soiled utensils before washing and for cleaned utensils following rinsing or sanitization; (2) Located and constructed so the tables or drainboards do not interfere with the proper use of the warewashing facilities; and (3) Not required for cooks' and bakers' rinse sinks; G. When spray-type warewashing machines are used: (1) The machines are installed: (a) According to manufacturer's specifications; and (b) To provide effective cleaning and sanitization of equipment and utensils; (2) The manufacturer's specifications are listed on a data plate that is permanently affixed to the machine; (3) If manufacturer's specifications for wash and rinse water temperature do not exist, the following standards are followed: (a) For machines using chemical sanitization, the wash and final rinse water temperature is at least 120°F; or (b) For machines using hot water sanitization, the wash water is at least: (i) 160°F for single tank conveyor machines; and (ii) 150°F for other types of machines; (c) For machines using hot water sanitization, the final or fresh rinse water temperature is at least: (i) 180°F at the entrance of the manifold; or (ii) 160°F when a pumped rinse is provided; (d) Wash water is kept clean and rinse water tanks are protected by: (i) Distance; (ii) Baffles; or (iii) Other means to minimize the entry of wash water into the rinse water; (e) The flow pressure is not less than 15 or more than 25 pounds per square inch on the water line immediately adjacent to the final rinse control valve; (f) Except for a pumped or recirculated final rinse, a pressure gauge is provided immediately upstream from the final rinse control valve to check the flow pressure of the final rinse water; and (g) An easily readable thermometer is provided to measure water temperature with an accuracy of plus or minus 2°F: (i) In each tank of the warewashing machine; and (ii) As the final rinse water enters the manifold; (4) Jets, nozzles, and all other parts of each machine are maintained free of: (a) Chemical deposits; (b) Debris; and (c) Other soil; and (5) If used, automatic detergent dispensers are maintained and operating; H. All warewashing machines are thoroughly cleaned as often as needed throughout the day to: (1) Prevent recontamination of equipment and utensils; and (2) Ensure that the equipment performs the equipment's intended function; I. A pre-rinse device is provided for all warewashing machines; J. Equipment and utensils are placed in racks, trays, baskets, or on conveyors after flushing, scraping, or soaking so that food contact surfaces are: (1) Subject to unobstructed application of detergent wash; (2) Rinsed thoroughly with clean rinse water to remove particulate matter and detergent residues; and (3) Drained; K. Warewashing machines using chemicals for sanitization meet the following additional requirements: (1) Chemicals added for sanitization purposes are automatically dispensed; and (2) The chemical sanitizer used: (a) Is listed in 21 CFR §178.1010; and (b) Provides the equivalent bactericidal effect of a solution containing at least 50 parts per million of chlorine; and (3) A test kit or other device that accurately measures the concentration of the sanitizing solution is used; L. Written approval is obtained from the approving authority when any other type of machine, device, or facilities and procedures for warewashing will be used based on a review that indicates compliance with §A of this regulation; M. Non-food contact surfaces of equipment are cleaned frequently enough to preclude the accumulation of soil residues; and N. Wiping cloths are: (1) Used only for wiping food spills; (2) Free of food debris when used dry for wiping food spills on tableware; and (3) Rinsed and stored in one of the sanitizing solutions specified in §C(1) of this regulation when used wet for wiping spills from the surfaces of equipment. #### Regulation .17 Storage and Handling of Cleaned Equipment and Utensils. *COMAR 10.15.03.17* The person-in-charge shall ensure that: A. Contamination of food-contact surfaces of cleaned and sanitized equipment and utensils is prevented by handling: (1) Cleaned spoons, knives, and forks by the utensil's handles only; and (2) Cleaned cups, glasses, and bowls so that hands do not contact inside surfaces or mouth-contact surfaces; B. The food-contact surfaces of equipment are protected from: (1) Splash; (2) Dust; and (3) Other contamination; C. Cleaned and sanitized food equipment, portable equipment, and utensils are stored: (1) A minimum of 18 inches above the floor when not fully protected by an enclosure with doors; (2) In a clean, dry location; and (3) In a space that affords protection from splash, dust, and other contamination; D. Utensils are: (1) Air dried before being stored; or (2) Stored in a self-draining position on hooks or racks constructed of a corrosion resistant material; E. Stored containers and utensils are covered or inverted whenever possible; F. Flatware is stored in containers designed to present the handle to the employee or customer; G. Toilet rooms or vestibules are not used to store: (1) Food equipment; (2) Utensils; or (3) Single service articles; and H. Single service articles are: (1) Stored in closed cartons or containers to protect the articles from contamination; (2) Handled and dispensed in a manner that prevents contamination of surfaces that come into contact with food or the mouth of the user; and (3) Used only once. #### Regulation .18 Control of Sanitary Facilities. *COMAR 10.15.03.18* The person-in-charge shall ensure that: A. Potable water is: (1) Obtained from a water supply system that complies with Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.04; and (2) Meets the standards of quality specified in Environment Article, Title 9, Annotated Code of Maryland, and COMAR 26.04.01; B. Non-potable water for non-culinary purposes such as air conditioning or fire protection is used only if the system complies with §H(3) of this regulation; C. Except for a temporary food service facility where water under pressure is not available, hot and cold running water under pressure is provided: (1) In all areas where: (a) Food is prepared; and (b) Equipment and utensils are washed; and (2) With sufficient water capacity, pressure, and hot water generation and distribution to meet peak demands throughout the facility; D. Drinking water, if not dispensed through the water supply system of the food service facility, is potable and stored in a container that meets all applicable laws, ordinances, and regulations; E. Steam that contacts food is free from deleterious or harmful matter that might adulterate food; F. All water-carried sewage is disposed of by: (1) A public sewerage system; or (2) An approved sewage disposal system constructed and operated in conformance with applicable State and local laws, ordinances, and regulations; G. Where water-carried disposal methods are not possible, non-water-carried sewage disposal facilities are utilized if: (1) The method has been approved by the approving authority as meeting State and local requirements; and (2) The facilities are: (a) In conformance with applicable State and local laws, ordinances, and regulations; and (b) Located outside and not attached to the establishment; H. Plumbing is sized, installed, and maintained so that: (1) The plumbing complies with applicable State and local plumbing laws, ordinances, and regulations; (2) The potable water supply system is: (a) Installed in a manner that prevents backflow or backsiphonage; and (b) Not connected with a non-potable water system in a manner that would allow non-potable water to be drawn or discharged into the potable water supply system; (3) The piping of a non-potable water system is: (a) Marked so that the piping is readily distinguishable from piping that carries potable water, such as with distinctive yellow-colored paint; and (b) Not connected to equipment or other outlets in the food preparation area; (4) Indirect waste piping is provided to a: (a) Food preparation or utensil washing sink; (b) Refrigerator coil; (c) Ice making machine; (d) Steam kettle; (e) Coffee urn or brewer; (f) Hot or cold drink machine; (g) Steam table; (h) Potato peeler; (i) Warewashing machine, unless: (i) The machine is located within 5 feet of a trapped floor drain; and (ii) The waste piping is connected directly to the inlet side of a floor drain trap vented in conformance with applicable State and local laws, ordinances, and regulations; and (j) Similar piece of equipment in which food, portable equipment, or utensils are placed; (5) Each compartment of a multiple compartment sink is indirectly drained to a trapped and vented plumbing receptor through an air gap that complies with State and local laws, regulations, and ordinances: (a) From a separate pipe through the air gap and into the plumbing receptor; or (b) Through the air gap into a single manifolded branch and into the plumbing receptor; (6) Plumbing receptors receiving the discharge of indirect waste pipes: (a) Have a shape and capacity that will prevent splashing or flooding; and (b) Are accessible for cleaning and inspection; (7) Food waste grinders are connected and trapped separately from other fixtures or sink compartments; (8) Floor drains subject to evaporation have: (a) A water seal of at least 4 inches; (b) Water fed from a plumbing fixture that complies with State and local laws, regulations, and ordinances; or (c) An automatic priming device that complies with State and local laws, regulations, and ordinances; (9) Floor drains in storerooms, refrigerated rooms, walk-in coolers, or other locations where food is stored, have indirect waste piping; (10) Hand sinks in food preparation tables and counters discharge through an air gap into a floor sink or receptor that is trapped and vented; and (11) Except when required by building design, waste pipes and fixtures are: (a) Not located over food storage, preparation, or serving areas; and (b) Where installed over food storage, preparation, or serving areas, food is protected by one or more of the following: (i) Pipe joining methods that will preclude leakage; (ii) Using wall-mounted fixtures; (iii) Limiting the number of pipe joints; (iv) Pressure testing the piping; (v) Thermally insulating pipes to prevent condensation; and (vi) Installing integral seepage pans or pipe sleeves; I. Toilet facilities are: (1) Sufficient in number to serve the facility; (2) Conveniently located; (3) Accessible to employees at all times; (4) Except as specified in Health-General Article, §21-325(b), Annotated Code of Maryland, for facilities established after January 1, 1979, provided for patrons whenever a food service facility: (a) Prepares food and provides seating; or (b) Is a carry-out facility with indoor tables used for dining; (5) Installed in accordance with applicable State and local laws, ordinances, and regulations; (6) Designed with fixtures that are: (a) Of sanitary design; and (b) Readily cleanable; (7) Kept: (a) Clean; (b) In good repair; and (c) Free of objectionable odor; and (8) Supplied with: (a) Toilet tissue at each toilet at all times; and (b) Receptacles that are easily cleanable and covered for waste materials in toilet rooms for women; J. Toilet rooms: (1) Are completely enclosed; (2) Are equipped with self-closing doors except when a toilet room without doors is approved by the approving authority based on a review that shows that: (a) Doors would impede the use of the toilet room; and (b) The requirements in §J(3)—(6) of this regulation are met; (3) Provide privacy; (4) Are provided mechanical ventilation that: (a) Exhausts air at the rate of 2 cubic feet per minute per square foot of floor area; and (b) Allows the entrance of an equal amount of makeup air; (5) Prevent the entry of insects and vermin; and (6) Do not open directly into the kitchen or food preparation areas; K. Hand washing facilities are: (1) Located: (a) In each food preparation and processing area; (b) In each utensil washing area; and (c) Adjacent to all toilet rooms; (2) Accessible at all times; (3) Equipped with an adequate supply of hand-cleaning soap or detergent; (4) Equipped with a means of drying hands, such as: (a) Individual towels in dispensers; or (b) An effective hand-drying device; (5) Equipped with a waste receptacle; and (6) Kept clean and in good repair; L. Hand sinks are: (1) Installed in accordance with applicable State and local laws, ordinances, and regulations; (2) Able to discharge: (a) Hot and cold running water; or (b) Tempered running water at a temperature of at least 100°F through: (i) A mixing valve; (ii) A combination faucet; or (iii) Any slow closing or metering faucet that provides a flow of water for at least 15 seconds before the faucet has to be reactivated; and M. Utensil washing vats, food preparation sinks, or mop sinks are not used as hand sinks. #### Regulation .19 Garbage and Rubbish Disposal. *COMAR 10.15.03.19* The person-in-charge shall ensure that: A. Garbage is stored in the following ways as applicable to the facility: (1) In containers that: (a) Are sufficient in number to hold all of the garbage that accumulates between periods of removal from the premises; (b) Do not leak or absorb liquids; (c) Are constructed of durable metal or another approved type of material; and (d) Are provided with tight-fitting lids or covers unless kept in a: (i) Vermin-proofed room or enclosure; or (ii) Waste refrigerator; (2) In storage areas that: (a) Are clean; and (b) Do not constitute a nuisance; (3) In storage rooms or enclosures that: (a) Are constructed of easily cleanable, grease resistant, washable materials; and (b) Are vermin-proofed; (4) In garbage containers outside the establishment that are located on a grease resistant, durable surface; and (5) For damaged, adulterated, or recalled products, in designated areas separate from: (a) Food; (b) Equipment; (c) Utensils; (d) Linens; and (e) Single service and single use articles that are held for credit, redemption, or return to the distributor; B. Garbage containers are cleaned as necessary to prevent a buildup of soil: (1) In a manner that does not contaminate food, equipment, utensils, or food preparation areas; (2) With: (a) Brushes for washing that may not be used for any other purpose; (b) Can-washing machines; (c) Steam-cleaning devices; or (d) Similar equipment; and (3) In an area that enables waste water from cleaning operations to be disposed of as sewage; C. Food waste grinders are: (1) Constructed and installed to comply with applicable State and local plumbing laws, ordinances, and regulations; and (2) Not connected to a sink drain that is used for food or utensils; D. All garbage and rubbish is disposed of: (1) Daily, or as often as necessary, to prevent a nuisance or insanitary condition; and (2) By a method that complies with applicable State and local laws, regulations, and ordinances; and E. Used cooking grease and oils are stored, recycled, and disposed of in accordance with applicable State and local laws, regulations, and ordinances. #### Regulation .20 Vermin Control. *COMAR 10.15.03.20* The person-in-charge shall ensure that: A. A food service facility may operate with its outer doors and windows open unless, while the food service facility is operating with the outer doors or outer windows open, the approving authority: (1) Finds evidence of vermin in food preparation or food storage areas; or (2) Finds evidence of flying insects in food preparation or food storage areas that pose a significant threat to sanitation or public health. B. If the approving authority finds that a food service facility is operating in violation of §A of this regulation, the food service facility shall take immediate action to eliminate the vermin or flying insects. C. If the approving authority finds that a food service facility is operating in violation of §A of this regulation, the approving authority may: (1) Close a food service facility; (2) Order a temporary closure of the outer windows and outer doors, until the vermin or flying insects are eliminated from the food preparation or food storage areas; or (3) Take another action to eliminate vermin or flying insects. D. A food service facility found to be operating in violation of §A of this regulation on three or more separate occasions shall keep the outer windows and outer doors closed at all times until: (1) Modifications approved by the local approving authority are made to the food service facility to effectively protect against the entrance of vermin and flying insects; or (2) Another action acceptable by the approval authority is taken. E. The person-in-charge shall ensure that: (1) Effective control measures are used to eliminate rodents, flies, roaches, and other vermin from the building; (2) The premises are kept clean and free of debris that will promote the harborage of vermin; (3) Openings into the building are effectively protected against the entrance of insects and rodents by: (a) Doors that are: (i) Tight; and (ii) Self-closing; (b) Screening on windows, doors, skylights, transoms, and other openings, which is: (i) Tight-fitting; (ii) In good repair; and (iii) Made of material that is not less than 16-mesh to the inch or equivalent; (c) Positive air pressure or controlled air currents; and (d) Other means acceptable to the approving authority; and (4) Insect control devices that are used to electrocute or stun flying insects are: (a) Designed to retain the insects within the device; (b) Not located over areas used to prepare food; and (c) Located so that dead insects and insect fragments are prevented from being impelled or from falling onto: (i) Exposed food; (ii) Clean equipment; (iii) Utensils; (iv) Linens; and (v) Unwrapped single service and single use articles. #### Regulation .21 Building — Floors, Walls, and Ceilings. *COMAR 10.15.03.21* The person-in-charge shall ensure that: A. A floor and floor covering is kept: (1) Clean; and (2) In good repair; B. The floor in a food preparation, food processing, food storage, utensil washing, dressing or locker, toilet, and walk-in refrigerator room or area is constructed of epoxy, sealed concrete, quarry tile, ceramic tile, commercial grade continuous sheet vinyl, or similar material that makes the floor: (1) Smooth; (2) Durable; (3) Nonabsorbent, unless the floor is in a: (a) Dry-food storage area; (b) Dining area; or (c) Mechanical or electrical room; (4) Easily cleanable; and (5) Grease resistant in areas subject to grease spillage or drippage; C. A floor installed in a food preparation, food processing, food storage, utensil washing, walk-in refrigerator, dressing or locker, and toilet room or area has a juncture between the floor and the wall that is: (1) Coved; and (2) Closed; D. A mat, floor covering, and duckboard is: (1) Removable; (2) Easily cleanable; and (3) Kept clean; E. When carpeting is used, the carpeting is placed only on the floors of: (1) Interior dining areas; (2) Retail areas where liquid products are not displayed; and (3) Areas not subject to water flushing, spraying, or drippage; F. When a floor receives water as a result of processing or cleaning, floor drains are provided at a minimum of one floor drain per 400 square feet of floor area; G. When floor drains are installed, floors are graded at not less than 1/8 inch per foot to direct wastewater to the floor drains; H. A floor in a room without floor drains that requires the removal of processing or wash-water, is drained by: (1) Sloping the floor at least 1/8 inch per foot toward a doorway or another opening; and (2) Directing the wastewater into a floor drain or other discharge point located outside the room in compliance with applicable State and local laws, regulations, and ordinances; I. The walking and driving surfaces of all exterior areas of food service facilities are: (1) Kept clean and free of debris; and (2) Surfaced with concrete, asphalt, gravel, or similar material to facilitate maintenance and minimize dusty or muddy conditions; J. A door on the building's exterior is equipped with a self-closing device; K. A wall, ceiling, door, window, skylight, and similar closure, is kept: (1) Clean; and (2) In good repair; L. The walls up to at least the highest level reached by splash or spray in all food preparation, food storage, utensil washing, and toilet rooms or areas have surfaces that are: (1) Smooth; (2) Washable; and (3) Water and grease resistant; M. A wall covering material, such as tile, stainless steel, fiber reinforced plastic, sealed gypsum board, or a similar material, is attached and sealed to the wall or ceiling so that: (1) There are no open spaces or cracks to permit accumulation of grease or soil; (2) The surface is easily cleanable; and (3) Harborage for vermin is prevented; N. Ceiling covering materials in food preparation and utensil washing areas: (1) Have smooth, washable surfaces; and (2) Do not contain fiberglass backing; O. Exposed construction, such as exposed floor and ceiling rafters, trusses or beams, utility ducts, and lighting, is: (1) Used only in: (a) A dry food storage area; (b) A dining area; or (c) Other areas with the approval of the approving authority based on applicable State and local laws, regulations, and ordinances; (2) Not used in: (a) A refrigerated food storage area; (b) A food preparation area; (c) An equipment and utensil washing area; and (d) A toilet room; and (3) Cleanable; and P. Piping, conduit, and similar construction located outside a wall is installed so that there is a minimum of 3/4 inch space between the piping, conduit, and similar construction and the wall. #### Regulation .22 Building — Lighting and Ventilation. *COMAR 10.15.03.22* The person-in-charge shall ensure that: A. Light fixtures, decorative material, and similar equipment and material attached to walls or ceilings are kept clean; B. Lighting provides artificial light at: (1) 50 footcandles at a surface where a food employee is working with food, utensils, or equipment; (2) 20 footcandles at 30 inches from the floor in a: (a) Storage area; (b) Toilet room; (c) Locker room; (d) Garbage and rubbish storage area; (e) Dining area during cleaning; (f) Utensil washing area; (g) Bar; (h) Wait station; and (i) Service area; or (3) Another lighting level approved by the approving authority based on a review that indicates the lighting level is sufficient for cleaning, facility maintenance, and employee safety. C. Light bulbs and tubes are shielded to prevent broken glass from falling onto food and utensils; D. Infrared or other heat lamps are protected against breakage by a shield surrounding and extending beyond the bulb, leaving only the face of the bulb exposed; E. The facility is ventilated with ventilation equipment that is maintained and operated so that: (1) All areas are kept reasonably free from: (a) Excessive heat; (b) Steam; (c) Condensation; (d) Vapors; (e) Smoke; and (f) Fumes; (2) Outside air is supplied: (a) Through: (i) The HVAC system; (ii) A separate supply fan; or (iii) A combination of the HVAC system and a separate supply fan; (b) So that the entry of outdoor contaminants is excluded by: (i) Maintaining the building under a slight positive pressure; and (ii) Providing an air filtering system; and (c) So that it does not reduce the effectiveness of the exhaust system; (3) Mechanical exhaust and make-up air systems are connected by an interlocking switch in order to provide make-up air whenever the exhaust system is in operation; and (4) Make-up air is tempered when necessary to: (a) Prevent the build-up of condensation that could: (i) Result in an unsanitary condition within the facility; and (ii) Contaminate food; (b) Provide comfortable working conditions; and (c) Comply with applicable building codes; F. Rooms, areas, and equipment from which aerosols, odors, fumes, or vapors may originate are effectively vented to the outside air by a system that does not create a harmful or unlawful discharge; G. A ventilation hood or other ventilation device or fixture is designed: (1) To prevent grease or condensate from dripping onto food or onto food preparation surfaces; (2) In compliance with NSF Standard 2; and (3) So that interior and exterior parts are easily accessible for maintenance and cleaning; H. Intake air ducts are designed and maintained to prevent the entrance of: (1) Dust; (2) Dirt; (3) Insects; or (4) Other contaminating materials; I. A grease removing exhaust hood is provided when needed over commercial cooking equipment that produces grease-laden vapors or smoke, such as: (1) Griddles; (2) Fryers; (3) Charbroilers; (4) Ovens used to cook fatty foods at a temperature which exceeds the vaporization point of grease; and (5) Solid fuel cooking equipment; J. A ventilation hood is provided over equipment where needed, for heat, fumes, and steam removal, including: (1) High temperature ovens not cooking fatty foods or not emitting grease vapors; (2) Steam kettles; and (3) Warewashing machines using hot water sanitization; K. Overshelves are used over cooking equipment under a hood only if: (1) Deflectors or the design of the overshelf prevents grease from condensing on the bottom of the overshelf and contaminating the food below; (2) Deflectors meet NSF or equivalent standards for food zone materials; and (3) The ability of the hood to capture grease vapors and smoke is not impaired; L. Equipment is not added or substituted under a hood that exceeds the capacity of the hood to remove: (1) Heat; (2) Steam; (3) Smoke; (4) Grease; (5) Fumes; and (6) Obnoxious odors; M. Except as provided in §N of this regulation, ventilation in toilet rooms is provided: (1) So that 2 cubic feet of air per minute per square foot of floor space is mechanically exhausted to the outside; and (2) With make-up air; N. When an existing building is converted for use as a food service facility and there is no feasible method to vent the toilet room to the exterior of the building, a ductless exhaust fan is used that: (1) Is sized and installed so that it will move 2 cubic feet of air per minute per square foot of floor area; and (2) Is serviced and maintained according to the manufacturer's specifications; and O. Required ventilation meets the provisions of this regulation: (1) Initially; and (2) For the life of the system. #### Regulation .23 Building — Cleanliness and Operations. *COMAR 10.15.03.23* A. The person-in-charge shall ensure that: (1) The facility and parts of the property associated with the operation of the facility are kept: (a) Clean; and (b) Free of litter and rubbish; (2) Traffic through the food operation and utensil washing areas is limited to on-duty personnel conducting pertinent job-related functions; (3) The facility is not used for living or sleeping quarters; (4) Sufficient space to store all custodial equipment is provided; (5) At least one utility sink or curbed cleaning facility with a floor drain is provided and used for: (a) Cleaning mops or similar wet floor cleaning tools; and (b) The disposal of mop water or similar liquid wastes; (6) A hand sink, utensil washing, equipment washing, or food preparation sink is not used as a mop or utility sink; (7) Except for emergency cleaning due to an accident or spill, all cleaning is done during periods when the least amount of food is exposed, such as after closing to the public; (8) Cleaning and sanitizing occur in a manner that protects food from contamination; (9) Vacuum cleaning, wet cleaning, other dustless methods of floor and wall cleaning, or dust-arresting sweeping compounds and brooms are used in a manner that: (a) Removes dust and soils; and (b) Prevents the contamination of food and food-contact surfaces; (10) Linens and clothes are stored: (a) Laundered and in a clean place until used; and (b) In non-absorbent containers or laundry bags when damp or soiled until removed for laundering; (11) Employee clothing and personal belongings are stored in: (a) Dressing rooms or dedicated areas that are: (i) Provided when employees change clothing within the facility; (ii) Located outside of food preparation, serving, and utensil washing areas; and (iii) Kept clean; and (b) Lockers or other facilities within dressing rooms or areas; and (12) Live birds and animals are not present on the premises of a food service facility except for: (a) Edible fish, shellfish, crustacea, or decorative fish in aquariums or display tank systems; (b) Service animals that are controlled by the individual with a disability; (c) Pets in the common dining areas of health care facilities at times other than during meals if: (i) Effective partitioning and self-closing doors separate the common dining areas from food storage and food preparation areas; (ii) Condiments, equipment, and utensils are stored in enclosed cabinets or removed from the common dining area when pets are present; and (iii) Dining areas including tables and countertops are cleaned and sanitized before the next meal service; and (d) A patron’s dog in an outdoor dining area of a food service facility in conformance with applicable State and local laws, ordinances, and regulations. B. Patrons' Dogs in Outdoor Dining Areas. (1) Subject to the requirements of §§B(2)—(5) of this regulation, an owner of a restaurant may allow a patron's dog to accompany the patron in the outdoor dining area during the hours designated by the restaurant. (2) Before an owner may allow a patron's dog to accompany the patron in the outdoor dining area, the owner shall: (a) Provide written notice to the approving authority or the local health department in the jurisdiction where the restaurant is located that the owner intends to allow patrons' dogs to accompany patrons in the outdoor dining area of the restaurant 30 days prior to the days dogs will be allowed; and (b) Place on permanent display in the restaurant a written notice that: (i) States the restaurant's policy of allowing patrons' dogs in an outdoor dining area; (ii) Is in a typeface that is large enough to be easily legible to the average person from a distance of 8 feet; and (iii) Is in a location that is plainly visible to the patrons of the restaurant. (3) In establishing the restaurant's policy concerning patron's dogs in outdoor dining areas, the owner may: (a) Determine the location and the amount of space designated for a patron accompanied by the patron's dog; and (b) Establish a limit on the size and type of dogs and any other limitations relating to a patron's dog. (4) At the owner's discretion, the owner may deny entry to the restaurant or eject from the restaurant any patron and the patron's dog. (5) A patron accompanied by a dog: (a) Shall: (i) Be an adult who is responsible for the behavior of the dog; (ii) Keep the dog with the patron on a leash at all times at the table at which the patron is seated; and (iii) Be liable for any damages caused by the dog to the restaurant or any other patron of the restaurant; and (b) May not: (i) Allow the dog to travel through an indoor space of a restaurant to enter or exit an outdoor dining area; or (ii) Leave the dog unattended at any time. #### Regulation .24 Food Manufacturing in Food Service Facilities. *COMAR 10.15.03.24* A. A person who is licensed to operate a food service facility may manufacture food for sale or distribution as provided in §§B, C, and E of this regulation. B. The person-in-charge shall ensure that before a food is manufactured in a food service facility: (1) Plans for the manufacturing: (a) Are submitted to the Department; (b) Are approved in writing by the Department based on a review that indicates compliance with this regulation; (c) Include: (i) A list of foods proposed for manufacture; (ii) The proposed processing procedures for a food; (iii) Specifications for equipment items to be used for manufacture; (iv) Packaging and labeling information; (v) Methods of shipment; (vi) Procedures for maintaining potentially hazardous food as set forth in Regulation .06B(7)—(13) of this chapter; and (vii) An HACCP plan in accordance with Regulation .34 of this chapter; and (2) The facilities and equipment proposed for use in manufacturing are: (a) Inspected by the Department; and (b) Approved in writing by the Department based on a review that indicates compliance with this chapter. C. A person licensed only to operate a food service facility may not manufacture the following foods: (1) Low-acid canned foods as defined in 21 CFR §113.3(n); (2) Acidified foods as defined in 21 CFR §114.3(b); (3) Hermetically sealed and ready-to-eat potentially hazardous foods that a hazard analysis indicates are associated with the outgrowth of Clostridium botulinum or Listeria monocytogenes, such as: (a) Smoked fish; or (b) Pasteurized crabmeat; (4) Bottled water; or (5) Soft drinks. D. The approving authority shall routinely inspect the food manufacturing conducted in the food service facility: (1) During inspections of the retail food service facility; and (2) At a frequency set forth in Regulation .30 of this chapter. E. The person-in-charge shall ensure that: (1) All manufactured food is labeled in accordance with Regulation .12 of this chapter; and (2) Records are: (a) Made to allow the trace-back of distributed or sold food to the food service facility that manufactured the food; (b) Made to identify the immediate source of the food and food ingredients stored and processed at the facility; (c) For shell eggs, made to provide the information required in COMAR 15.04.01.03A(2)(a)—(e); (d) Made to identify the initial distribution of the food to facilitate the segregation of food that may have become adulterated or otherwise unfit for human consumption; and (e) Maintained at the facility for at least: (i) 2 years for a shelf stable or preserved food; and (ii) 1 year for a fresh food. #### Regulation .25 Special Food Service Facilities. *COMAR 10.15.03.25* A. For a special food service facility that handles only potentially hazardous food that remains in the original container or wrapping and that does not prepare, wrap, or package the food at the facility, the person-in-charge shall ensure that: (1) Compliance is maintained with Regulations .01—.06, .08, .12—.14, .15A(3)—(5), .19—.23, .25, .28—.33, and .35—.39 of this chapter; and (2) When single service articles are used, the single service articles comply with Regulation .17H of this chapter. B. For a special food service facility that handles food that is removed from the original package or that prepares, packages, or wraps food at the facility, the person-in-charge shall ensure that: (1) Compliance is maintained with Regulations .01—.06, .08—.14, .15A(3)—(10), .16—.25, and .28—.39 of this chapter; (2) The premises are kept clean and free of litter or rubbish; (3) If permanent toilet facilities are not required, temporary toilet facilities are made available and maintained in a sanitary manner; (4) Except as provided in §D(2) of this regulation, adequate hand washing facilities are provided by: (a) Where potable water under pressure is available, a hand sink as set forth in Regulation .18K and L of this chapter; or (b) Another hand washing facility that has: (i) Warm water; (ii) Soap; and (iii) Paper towels; and (5) Wastewater from hand washing, food preparation, and cleaning is disposed of in accordance with State and local laws, regulations, and ordinances. C. For a special food service facility that is a mobile unit, the person-in-charge shall ensure that: (1) Compliance is maintained with either §A or B of this regulation as applicable; (2) Equipment components of the mobile unit are in compliance with Regulation .15A(1) and (2) or B of this chapter; (3) A hand washing sink is provided as set forth in Regulation .18K and L of this chapter; (4) Potable water tanks are used to provide water for hand washing and, where applicable, for food preparation and utensil cleaning; (5) Wastewater tanks are used to hold wastewater pending disposal at a facility in a manner that conforms with State and local laws, regulations, and ordinances; (6) Subject to §C(8) and (9) of this regulation, a base of operations is established that provides: (a) A source of potable water, potable water hoses, and clean connections; (b) A method for the disposal of sewage; (c) Clean, adequate, and covered trash receptacles; (d) A storage area for single serve food items; and (e) If necessary: (i) Refrigerated and dry food storage areas; and (ii) A utensil washing facility. (7) The base of operation is located within 90 miles of the licensing county; (8) For a mobile food service facility not seeking a mobile reciprocity license, a base of operations as set forth in §C(6) and (7) of this regulation is established by May 1, 2020; (9) A base of operations is not required for a mobile food service facility that offers only prepackaged frozen desserts; (10) A valid license from the county of origin is maintained; and (11) Compliance is maintained with all applicable State and local laws and regulations in the jurisdiction in which it is operating. D. For a special food service facility that is a temporary food service facility, the person-in-charge shall ensure that: (1) Compliance is maintained with either §A or B of this regulation as applicable, except that no compliance with Regulations .21 and .22 of this chapter is required; (2) Where potable water under pressure is not available, sufficient containerized potable water is provided for: (a) Hand washing; and (b) Rinsing utensils; and (3) The period of time that the facility operates is limited to the time stated in Regulation .02B(80) of this chapter. E. For a special food service that is a bed and breakfast, the person-in-charge shall ensure that: (1) Compliance is maintained with either §A or B of this regulation as applicable; (2) The facility serves hot meals only to renters; and (3) The facility does not operate as a restaurant or caterer. F. For a special food service facility that is a semi-permanent food service facility, the person-in-charge shall ensure that: (1) Compliance is maintained with either §A or B of this chapter as applicable; (2) A connection to potable water is maintained as a critical item, as set forth in Regulation .18A of this chapter; (3) Hand sinks are provided and maintained as set forth in Regulation .18K and L of this chapter; and (4) A connection to a sewage disposal system is provided and maintained as a critical item that meets applicable State and local laws, regulations, and ordinances. G. For a special food service facility that is an on-farm food service facility, the person-in-charge shall ensure that: (1) Compliance is maintained with either §A or B of this regulation as applicable, except that no compliance with Regulations .21 and .22 of this chapter is required; (2) Hand washing stations are provided in close proximity to the food service facility for use by customers; (3) Signs are displayed prominently at the hand washing stations stating “In the interests of public health, please wash your hands thoroughly before entering or handling food.”; and (4) The period of time that the facility operates is limited to the time in Regulation .02B(48) of this chapter. H. For a special food service facility that is a seasonal farmer’s market producer sampling food service facility, the person-in-charge shall ensure that: (1) Compliance is maintained with §B of this regulation when food is removed from the original package or food is prepared at the facility, except that no compliance with Regulations .21 and .22 of this chapter is required; (2) Where potable water under pressure is not available, sufficient containerized potable water is provided for: (a) Hand washing; and (b) Rinsing utensils; and (3) The period of time that the facility operates is limited to the time stated in Regulation .02B(70) of this chapter. #### Regulation .26 Excluded Organizations. *COMAR 10.15.03.26* A. Pursuant to Health-General Article, §21-304(a)(2), Annotated Code of Maryland, a volunteer fire company or bona fide nonprofit fraternal, civic, war veterans’, religious, or charitable organization or corporation that does not serve food to the public more often than 4 days per week, except that once a year an organization may serve food to the public for up to 30 consecutive days, may make: (1) A rescindable decision to operate as a licensed food service facility and in full compliance with this chapter; or (2) A decision to operate without a license and in compliance with §§B—E of this regulation, which establish the minimum requirements to ensure food safety at a food preparation or serving area operated by an excluded organization without a license. B. The person-in-charge shall ensure that a food preparation or service area operated by an excluded organization without a license complies with Regulations .01—.15A(3)—(10), .16—.23, .26—.27, and .29—.39 of this chapter. C. During the operation of a special food service facility, the person-in-charge of an unlicensed excluded organization shall ensure compliance with: (1) Regulations .01—.06, .08, .12—.14, .15A(3)—(5), .19—.20, .22B—D, .23, .26, .29—.33, and .35—.39 of this chapter, if the unlicensed excluded organization is a special food service facility that: (a) Handles only potentially hazardous food that remains within the original container or wrapping; and (b) Does not prepare, wrap, or package food at the facility; or (2) Regulations .01—.06, .08—.14, .15A(3)—(10), .16—.20, .22B—D, .23, .26, and .29—.39 of this chapter, if the unlicensed excluded organization is a special food service facility that: (a) Handles food that is removed from the original container or wrapping; or (b) Prepares, packs, or wraps potentially hazardous food at the facility. D. The person-in-charge shall ensure that an unlicensed excluded organization does not: (1) Operate a bed and breakfast; (2) Operate a semi-permanent food service; or (3) Except as provided for in §G of this regulation, perform retail food manufacturing. E. The person-in-charge shall ensure that, when an unlicensed excluded organization plans a single event to prepare or serve potentially hazardous food to 200 or more individuals from the public: (1) Written notification of the event is submitted to the approving authority not less than 30 days before the scheduled event; and (2) The written notification required in §E(1) of this regulation contains: (a) The date, place, and time of the event; (b) The estimated number of individuals to be served at the event; (c) A menu or list of foods to be served; (d) The source of all potentially hazardous foods to be served; (e) A list of foods to be prepared more than 12 hours in advance of service; (f) If food is to be prepared off-premises, the: (i) Name of the facility to be used; and (ii) Procedures for transporting food to the premises; (g) The name, address, and telephone number of a responsible contact individual; and (h) Any other information requested by the approving authority in order to review the food preparation and service. F. The person-in-charge shall ensure that when an unlicensed excluded organization plans to serve food to the public for up to 30 consecutive days, a written notice is provided to the Department that includes the: (1) Dates on which the food will be prepared; (2) Methods of storing and serving food; and (3) Methods or procedures that will be followed to ensure food: (a) Safety; and (b) Security. G. In Carroll County, a religious organization that meets the definition of an excluded organization as set forth in Regulation .02B(28) of this chapter, and complies with COMAR 10.15.01.09A—D and .10A and 10.15.04.08, or a county-owned and county-operated park or facility that is hosting a public festival, may offer for sale directly to the public the following types of homemade style food, only if the food is produced at the kitchen of the excluded organization: (1) Fruit butter made only from: (a) Apples; (b) Apricots; (c) Grapes; (d) Peaches; (e) Plums; or (f) Quince; (2) Jam, preserve, or jelly, made only from: (a) A fruit listed in §G(1) of this regulation; (b) Oranges; (c) Nectarines; (d) Tangerines; (e) Blackberries; (f) Raspberries; (g) Blueberries; (h) Boysenberries; (i) Cherries; (j) Cranberries; (k) Strawberries; or (l) Red currants; (3) Fruit pies made from a fruit listed in §G(1) and (2) of this regulation; and (4) Honey. #### Regulation .27 Farmer's Market, Bake Sales, and Cottage Food Business. *COMAR 10.15.03.27* A. A cottage food business may offer for sale the homemade foods specified in §B of this regulation when the foods are: (1) Made in a private home kitchen; and (2) Offered or sold only in the State: (a) Subject to the requirements of §C(6) and (7) of this regulation, at a retail food store; or (b) Directly to a consumer: (i) At a farmer’s market; (ii) At a bake sale; (iii) At a public event; (iv) By personal delivery; or (v) By mail order. B. The Department shall allow the preparation and sale of the following foods in accordance with §A of this regulation: (1) Non-potentially hazardous hot-filled canned acid fruit jellies, jams, preserves, and butters that are: (a) Unadulterated; (b) Packaged to maintain food safety and integrity; and (c) Labeled in accordance with Regulation .12 of this chapter; (2) Fruit butters made only from: (a) Apples; (b) Apricots; (c) Grapes; (d) Peaches; (e) Plums; (f) Prunes; (g) Quince; or (h) Another fruit or fruit mixture that will produce an acid canned food; (3) Jam, preserve, or jelly made only from: (a) A fruit listed in §B(2) of this regulation; (b) Oranges; (c) Nectarines; (d) Tangerines; (e) Blackberries; (f) Raspberries; (g) Blueberries; (h) Boysenberries; (i) Cherries; (j) Cranberries; (k) Strawberries; (l) Red currants; or (m) Another fruit or fruit mixture that will produce an acid canned food; (4) Non-potentially hazardous baked goods; (5) Foods manufactured on a farm by a licensed food processor in accordance with COMAR 10.15.04.19; (6) Non-potentially hazardous candy; and (7) All other non-potentially hazardous foods produced by a licensed entity. C. Cottage Food Business. (1) The Department shall allow the owner of a cottage food business to sell only cottage food products processed and packaged in Maryland that are: (a) Produced or packaged in a residential kitchen; (b) Stored on the premises of the cottage food business; and (c) Prepackaged with a label that contains the following information: (i) The name and address of the cottage food business or the name, phone number, and identification number assigned to the cottage food business by the Department; (ii) The name of the cottage food product; (iii) The ingredients of the cottage food product in descending order of the amount of each ingredient by weight; (iv) The net weight or net volume of the cottage food product; (v) Allergen information as specified by federal labeling requirements; (vi) Nutritional information as specified by federal labeling requirements, if any nutritional information claim is made; (vii) Printed in 10 point or larger type in a color that provides a clear contrast to the background of the label: “Made by a cottage food business that is not subject to Maryland’s food safety regulations.”; and (viii) For a cottage food product offered for sale at a retail food store, the phone number and email address of the cottage food business and the date the cottage food product was made. (2) A cottage food business may request a unique identification number from the Department which can be used in lieu of the address of the cottage food business on the product label required under §C(1) of this regulation. (3) The owner of a cottage food business shall comply with all applicable county and municipal laws and ordinances regulating the preparation, processing, storage, and sale of cottage food products. (4) Upon receipt of a complaint or outbreak of illness the Department may: (a) Investigate the conditions under which the product was produced and any complaint alleging that a cottage food business has violated this regulation; (b) Send a representative of the Department, at a reasonable time, to enter and inspect the premises of a cottage food business to determine compliance with this regulation; and (c) Collect samples of a cottage food product or its ingredients to determine if the cottage food product is misbranded or adulterated. (5) The owner of a cottage food business may not: (a) Refuse to grant access to a representative who requests to enter and inspect the premises of the cottage food business in response to a complaint; or (b) Interfere with any inspection or collection of samples in response to a complaint or outbreak of illness. (6) Before the owner of a cottage food business may sell a cottage food product to a retail food store, the owner shall submit to the Department for review: (a) The label that will be affixed to the cottage food product in accordance with §C(1)(c) of this regulation; and (b) Documentation of the owner’s successful completion of a food safety course in the past 3 years that is approved by the Department and the American National Standards Institute and includes, at a minimum, the following subjects: (i) Basic food safety; (ii) Cleaning and sanitizing; (iii) Personal hygiene; (iv) Pest control and prevention; and (v) Receiving, storing, preparing, and serving food. (7) The owner of a cottage food business may not sell or offer for sale a cottage food product to a retail food store until notified by the Department, in writing, that the requirements stated in §C(6) of this regulation are satisfactorily met. (8) The phone number required in §§C(1)(c)(i) and (viii) of this regulation shall enable contact with the cottage food business by the Department within 24 hours. (9) The email address required in §C(1)(c)(i) of this regulation shall enable contact with the cottage food business by the Department within 48 hours. D. If the Department finds a person to be in violation of any provision of this regulation, the Department: (1) Shall take action against a misbranded or adulterated food offered or sold under this regulation in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland; and (2) May determine that food produced in a private home kitchen by the person may not be offered for sale as a cottage food. #### Regulation .28 Licenses. *COMAR 10.15.03.28* A. The approving authority shall require a farmer to obtain a producer mobile farmer's market unit license as specified in COMAR 10.01.17 and 10.15.04 for the sale of a farm product at a farmer's market or at a public event that is not: (1) A raw agricultural product as defined in Regulation .02B(61) of this chapter; or (2) A pre-packaged non-potentially hazardous food. B. A local health department may: (1) Not require a farmer to obtain a producer mobile farmer's market unit license for that local jurisdiction; and (2) Require a farmer to obtain a seasonal farmer's market producer sampling license if the farmer prepares and offers samples of a farm product for human consumption at a farmer's market or at a public event in that local jurisdiction. C. The approving authority shall issue and renew licenses in accordance with Health-General Article, §§21-309 and 21-310, Annotated Code of Maryland, and this chapter. D. The approving authority may deny an application for a food service facility license in accordance with Health-General Article, §21-311, Annotated Code of Maryland, and this chapter. E. A person: (1) Shall obtain a food service facility license before the person operates a food service facility; and (2) May not operate a food service facility if the person does not have a current and valid license issued by the approving authority, except: (a) As provided in: (i) Health-General Article, §21-305, Annotated Code of Maryland; and (ii) Regulation .26A(2) of this chapter; or (b) A caterer: (i) As provided in §G of this regulation; or (ii) When from outside the State, that conforms to the provisions of this chapter or to substantially equivalent provisions as indicated by a report from the caterer's licensing agency to the approving authority indicating that the facility is licensed and inspected in the jurisdiction where the food service facility is located. F. The person-in-charge shall ensure that: (1) Application for a food service facility license is submitted in accordance with Health-General Article, §§21-306 and 21-307, Annotated Code of Maryland; (2) A valid license is displayed in a conspicuous place in the food service facility; and (3) When catering services are offered, the food service facility license number and the identity of the issuer of the number are located: (a) On advertising and business cards; (b) In published print media; (c) On flyers; (d) In brochures; (e) On vehicles used in connection with catering services; (f) On contracts for catering services; (g) In telephone directories; and (h) In or on any other advertising and solicitations. G. The approving authority may not require a caterer licensed in Maryland to obtain a separate license for each catered event, including events across jurisdictional lines within the State, when the: (1) Major food preparation for the event is completed at the caterer's food service facility, including: (a) Thawing potentially hazardous food; (b) Cooking potentially hazardous food, except at outdoor barbecues when the food will be immediately consumed or discarded; (c) Cooling potentially hazardous food; or (d) Preparing salads that contain potentially hazardous foods; and (2) Event is at a location other than the caterer’s food service facility if the caterer and location comply with Regulations .01—.06, .08—.14, .15A(3)—(8), and .18I and L of this chapter. H. Except as provided in §I of this regulation, a license may not be transferred from one person to another person or from one food service facility to another. I. Upon the death of a licensee, the approving authority may transfer a food service facility license if: (1) An application is filed in accordance with Health-General Article, §21-306, Annotated Code of Maryland; and (2) Written evidence establishes that the applicant's relationship with the deceased was as a: (a) Spouse of the deceased licensee; (b) Blood relative to the first degree of consanguinity; or (c) Current officer or surviving partner in the business operating the food service facility. J. A local health department: (1) Shall issue a mobile reciprocity license: (a) In accordance with Health-General Article, §21-304, Annotated Code of Maryland; (b) To a mobile food service facility that: (i) Holds a valid license from the county of origin; (ii) Is operating in the jurisdiction; and (iii) Is operating within 90 miles of its base of operations, which shall be located in Maryland. (2) Shall provide copies of inspection or other supporting documentation for a mobile food service facility with a base of operations within the jurisdiction of the local health department to the jurisdiction in which the mobile food service facility is seeking a mobile reciprocity license; (3) May inspect the mobile food service facility during operation in the jurisdiction after a mobile reciprocity license has been issued; (4) May suspend a mobile reciprocity license for not maintaining a valid license from the county of origin until such time that the county of origin license is renewed; (5) May issue a violation of this regulation as set forth in Regulation .35 of this chapter; and (6) Shall notify all known Maryland jurisdictions which license the mobile food service facility if: (a) Any fines are issued to a mobile reciprocity licensee; or (b) Enforcement action is taken against a mobile reciprocity licensee under §J(3) of this regulation. K. A mobile reciprocity license: (1) May not exceed $300; and (2) Is valid for a period of 1 year. #### Regulation .29 Food Service Facility Inspections — General. *COMAR 10.15.03.29* A. The person-in-charge shall permit a representative of the approving authority to: (1) Enter a food service facility at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and (2) Examine the records of the facility that pertain to information regarding food and supplies purchased, received, or used. B. The person-in-charge shall inform the approving authority of, and keep confidential, a food ingredient or a recipe that the person-in-charge considers a trade secret, except as provided in §C of this regulation. C. The person-in-charge shall furnish information to the approving authority regarding a food ingredient or recipe that the person-in-charge considers a trade secret if: (1) An immediate and substantial danger to public health exists involving the food ingredient or recipe; or (2) The approving authority determines that the information about the food ingredient or recipe is necessary to conduct a foodborne disease investigation. D. The approving authority shall maintain the confidentiality of trade secret information in accordance with State Government Article, §10-617, and Health-General Article, §21-259, Annotated Code of Maryland. E. When an inspection of a food service facility is made, the approving authority shall: (1) Document: (a) The inspection results on an inspection report form provided by the Department; and (b) On the report: (i) Conditions found that violate the provisions of this chapter; and (ii) Critical item violations, noted separately from all other violations; (2) Furnish one copy of the inspection report to the person-in-charge of the facility; and (3) Make the completed inspection report form available for public disclosure in accordance with State Government Article, §10-611—10-628, Annotated Code of Maryland. #### Regulation .30 Food Service Facility Inspections — Types and Frequencies. *COMAR 10.15.03.30* The approving authority shall ensure that: A. The following types of inspections are conducted: (1) A comprehensive inspection that contains: (a) A monitoring inspection as set forth in §A(2) of this regulation; (b) A HACCP compliance inspection as set forth in §A(3) of this regulation; and (c) An inspection of the physical facility to ensure compliance with the applicable sections of this chapter, including those governing: (i) Floors; (ii) Walls; (iii) Ceilings; (iv) Lighting; (v) Ventilation; (vi) Hoods; (vii) Food equipment; (viii) Toxic substances and cleaning supplies storage and use; (ix) Cleaning, rinsing, and sanitizing; (x) Mechanical warewashers; (xi) Insects, rodents, birds, or other animals; (xii) Trash disposal; (xiii) Hand sinks; (xiv) Bathroom fixtures; and (xv) Backflow and backsiphonage prevention; (2) A monitoring inspection that contains: (a) An inspection for compliance with critical items as: (i) Defined in Regulation .02B(19) of this chapter; and (ii) Outlined in §C of this regulation; (b) A menu review to determine whether the existing priority assessment is correct; and (c) An evaluation of the physical facility to ensure that food is protected; and (3) A HACCP compliance inspection that contains: (a) An inspection for compliance with Regulation .34 of this chapter; (b) A comparison of the HACCP plan on site to the current menu; (c) An evaluation of the food preparation in progress to ensure that each CCP: (i) Is properly identified; (ii) Is monitored according to the procedures contained in the HACCP plan; and (iii) Has a corrective action that is implemented according to procedures contained in the HACCP plan; (d) Verification that the procedures used to monitor each CCP are accurate; and (e) Action to: (i) Enforce compliance with the HACCP plan; or (ii) Have the existing HACCP plan revised to comply with Regulation .33E and F of this chapter; B. The person-in-charge is in compliance with critical items when the person-in-charge: (1) Receives food from approved sources; (2) Protects food from adulteration; (3) Ensures that an individual who works with food: (a) Washes hands as necessary to protect food and food contact surfaces from contamination; and (b) Is excluded if ill as set forth in Regulation .14A and B of this chapter; (4) Cools potentially hazardous food: (a) As set forth in Regulation .11A—C of this chapter; and (b) In equipment that complies with Regulation .15 of this chapter; (5) Maintains potentially hazardous food: (a) Hot: (i) At hot holding temperatures as set forth in Regulation .06B(7) of this chapter; and (ii) In equipment that complies with Regulation .15 of this chapter; or (b) Cold: (i) At refrigeration temperatures as set forth in Regulation .06B(7) of this chapter; and (ii) In equipment that complies with Regulation .15 of this chapter; (6) Cooks and reheats potentially hazardous food: (a) As set forth in Regulations .10 and .11D of this chapter; and (b) In equipment that complies with Regulation .15 of this chapter; (7) Provides an adequate supply of potable water for: (a) Food preparation; (b) Hand washing; (c) Utensil washing; (d) Toilet facilities; and (e) Facility sanitation; and (8) Properly discharges sewage as set forth in Regulation .18F and G of this chapter; C. A food service facility is inspected: (1) As needed for the enforcement of this chapter; (2) When a high priority food service facility: (a) At a minimum frequency of three times per year, one at every 4-month interval; (b) Except as provided in §D of this regulation, using: (i) A comprehensive inspection; and (ii) Two monitoring inspections; and (c) That operates fewer than 12 months in a year, using one comprehensive inspection: (i) Per operating season if the operating season is less than 4 months; or (ii) During each 4 month interval if the operating season is 4 months or greater; (3) When a moderate priority food service facility: (a) At a minimum of two times per year, one every 6 months; (b) Except as provided in §D of this regulation, using: (i) A comprehensive inspection; and (ii) A monitoring inspection; and (c) That operates fewer than 12 months a year, using a comprehensive inspection during each period of 6 months or less; (4) When a low priority food service facility, using a comprehensive inspection at a minimum of once every 2 years except that a HACCP compliance inspection is not required; (5) When a temporary food service facility, using a monitoring inspection as set forth in Regulation .30A(2) of this chapter during each licensure period; and (6) When a seasonal farmer’s market producer sampling food service facility, using a monitoring inspection: (a) A minimum of two times per year, once every 6-month interval; (b) Except as provided in §D of this regulation; and (c) That operates fewer than 12 months in a year: (i) Per operating season if the operating season is less than 6 months; or (ii) During each 6-month interval if the operating season is 6 months or greater; and D. A food service facility is inspected as soon as possible when the food service facility has been associated with foodborne illness, using a: (1) HACCP compliance inspection that focuses on the food implicated with illness; and (2) Upon completion of the HACCP compliance inspection, either a: (a) Comprehensive inspection; or (b) Monitoring inspection. #### Regulation .31 Time Period for Correction of Violations. *COMAR 10.15.03.31* A. The person-in-charge shall correct: (1) Critical item violations immediately; (2) Other violations except as provided in §A(3) of this regulation within: (a) 30 days of the inspection; or (b) Another time period specified by the approving authority based on applicable State and local laws, regulations, and ordinances; and (3) Other violations at a temporary food service facility within: (a) 24 hours of the inspection; or (b) Another time period specified by the approving authority based on applicable State and local laws, regulations, and ordinances. B. The approving authority may modify the specified time period for correcting a violation if the person-in-charge: (1) Submits a written schedule of compliance within a time frame for correcting a violation that is acceptable to the approving authority; and (2) There is no immediate or substantial danger to public health. #### Regulation .32 Required Postings. *COMAR 10.15.03.32* The person-in-charge shall ensure that a food service facility: A. That prepares food and provides seating for patrons posts a diagram on the use of manual maneuvers to prevent asphyxiation due to choking, in accordance with Health-General Article, §21-326, Annotated Code of Maryland; and B. Displays prominently in the staff area of the food establishment a poster related to food allergy awareness that includes information regarding the risk of an allergic reaction, in accordance with Health-General Article, §21-330.2(a), Annotated Code of Maryland. #### Regulation .33 Plan Review. *COMAR 10.15.03.33* A. The person-in-charge shall ensure that plans and specifications are submitted to and approved by the approving authority before a food establishment is: (1) Constructed; (2) Remodeled; or (3) Materially altered. B. The person-in-charge shall ensure that the information submitted to the approving authority includes: (1) A scale drawing of the proposed facility that identifies the layout and arrangement of work areas and the location of all equipment; (2) A description of: (a) Materials to be used for interior finishes; (b) The layout and types of lighting to be used; (c) The proposed ventilation system; and (d) Methods and facilities for trash storage and disposal; (3) A plumbing diagram, including specifications of the method of sewage disposal and the source of potable water; (4) A complete list of specifications for the proposed food equipment; (5) A menu or other written description of the foods to be prepared or served; (6) General food handling information and procedures for: (a) Receiving; (b) Storage; (c) Thawing; and (d) Preparation; (7) A list of foods that will be: (a) Prepared in advance of service; or (b) Distributed off premises; (8) A description of the food systems that will be used, such as: (a) Cook-hot hold-serve; (b) Cook-cool-reheat-hot hold-serve; and (c) Cook-cool-cold hold-serve; and (9) Any other information that is required by the approving authority to ascertain compliance of the plans and specifications with all applicable State and local laws, regulations, and ordinances. C. The approving authority shall: (1) Conduct a priority assessment of the facility based upon the information obtained in §B of this regulation; (2) Classify each food service facility as a: (a) High priority facility; (b) Moderate priority facility; or (c) Low priority facility; (3) Designate as a high priority facility, a facility that: (a) Is a health care facility; or (b) Serves potentially hazardous food that is prepared: (i) A day or more in advance of service; or (ii) Using food preparation methods that require the food to pass through the temperature range of 41°F to 135°F two or more times before service, such as cooking, cooling, and then reheating; (4) Designate as a moderate priority facility, a facility that serves potentially hazardous food: (a) That is prepared using methods that require the food to pass through the temperature range of 41°F to 135°F not more than one time before service, such as cooking, hot holding, and then serving; or (b) That is cut, assembled, or packaged on the premises, such as meats; and (5) Designate as a low priority facility, a facility that serves: (a) Commercially packaged potentially hazardous foods directly to the consumer; (b) Non-potentially hazardous food that is cut, assembled, or packaged on the premises, such as candy, popcorn, and baked goods; or (c) Hand dipped ice cream. D. Except for a temporary food service facility, the person-in-charge shall ensure that a HACCP plan is submitted to the approving authority for each high or moderate priority facility as specified in §C of this regulation. E. The person-in-charge shall ensure that the HACCP plan includes the: (1) Identification of each CCP; (2) Critical limits for each CCP; (3) Monitoring procedures at each CCP; (4) Corrective action that will be taken if there is a loss of control at a CCP due to: (a) Employee error; (b) Equipment malfunction; (c) Power failure; or (d) Any other factor that causes loss of control at a CCP; (5) Verification procedures that will ensure proper monitoring of each CCP, such as: (a) Calibration of cooking and holding equipment and thermometers; and (b) Review of records such as temperature logs; (6) Written procedures for employee training in HACCP plan procedures; and (7) A list of the food service equipment that will be used at each CCP. F. The person-in-charge shall construct the HACCP plan by: (1) Listing, for each CCP, the: (a) Menu items controlled by the CCP; (b) Equipment used; and (c) Monitoring, corrective action, and verification procedures; (2) Incorporation of the requirements of §E of this regulation into a recipe or preparation instructions; or (3) Another way that meets the requirements of §E of this regulation. #### Regulation .34 HACCP Plan Compliance. *COMAR 10.15.03.34* The person-in-charge of a high or moderate priority food service facility shall ensure that: A. A HACCP plan is: (1) In compliance with Regulation .33E and F of this chapter; (2) Within the food preparation area during operation; (3) Readily accessible to employees at all times; and (4) Updated as follows: (a) When a change in food processes or procedures change one or more CCP; and (b) At least once every 5 years; B. An employee involved in food preparation is trained in the HACCP procedures; and C. Changes to the HACCP plan are submitted to the approving authority before implementation of the HACCP plan. #### Regulation .35 Enforcement Procedures. *COMAR 10.15.03.35* A. The approving authority shall ensure that when a food service facility is found in violation of any provision of this chapter, the licensee is notified: (1) Of the specific findings; (2) Of a specific date by which the licensee shall correct the violations or deficiencies; and (3) That, if the licensee fails to correct the violation by the date specified, the approving authority may suspend or revoke the license. B. When a person is violating any provision of this chapter, the approving authority may serve the person with a written order pursuant to Health-General Article, §21-318 or 21-261, Annotated Code of Maryland, directing the person to abate the violation within a specified time period. C. When an inspection indicates that an immediate and substantial danger to public health exists and requires emergency action at a facility operated by an excluded organization, the approving authority may seek injunctive relief as provided in Health-General Article, §§21-1214 and 21-1215, Annotated Code of Maryland. D. The approving authority shall ensure that an opportunity for a hearing is provided to a person served with an order, pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. E. In order to preserve a right to a hearing under any provision of this regulation, a person shall: (1) Make a request for a hearing in writing; and (2) Submit the request to the approving authority that issued the order or inspection report: (a) Within 10 days of receipt of the order; (b) Sooner if specified in the order; or (c) Within 24 hours if: (i) The violation requires immediate correction or correction within 24 hours; or (ii) The facility is a temporary food service facility. F. The approving authority shall suspend or revoke the license of a food service facility if the licensee fails or neglects to: (1) Correct a violation within the specified time period; (2) Comply with an approved written schedule of compliance; (3) Correct a critical item immediately; or (4) Correct a violation in a temporary food service facility within 24 hours. G. The approving authority shall ensure that an action to suspend or revoke a license: (1) Complies with the provisions of: (a) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and (b) Health-General Article, §21-315, Annotated Code of Maryland; and (2) The person against whom the action is contemplated is given an opportunity for a hearing in accordance with Health-General Article, §21-316, Annotated Code of Maryland. H. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, the: (1) Approving authority shall: (a) Summarily suspend the license at a food service facility; (b) Order the food service facility to cease operation immediately; and (c) Promptly provide the licensee with: (i) A written notice of suspension of the license; (ii) The reasons for the suspension; and (iii) An opportunity to be heard; and (2) Person-in-charge shall immediately cease the operation of the food service facility. I. The person-in-charge shall ensure that a food service facility that has been required under the provisions of this regulation to cease operations does not resume operations until a reinspection by the approving authority shows that the condition or conditions responsible for the requirement to cease operations no longer exists. J. The approving authority shall ensure that appropriate steps are taken to ensure that the licensee ceases operation of the food service facility upon suspension or revocation of the license, including: (1) Taking and keeping physical possession of the license until the license is reinstated; (2) Posting a sign on the facility door stating that the license has been suspended or revoked by the approving authority; or (3) Taking another measure within the law that will ensure that the facility does not operate. K. A person whose food service facility license has been suspended or revoked may apply for reinspection and reinstatement of the license by submitting to the approving authority a written request that details the actions taken by the person to correct each violation of a food statute or regulation that caused the suspension or revocation. #### Regulation .36 Foodborne Disease Investigation and Control. *COMAR 10.15.03.36* The approving authority shall ensure that: A. When there is reasonable cause to suspect foodborne disease transmission from a food service facility employee: (1) A morbidity history of the suspected employee is taken; (2) An investigation is conducted; and (3) The appropriate follow-up action is taken that may include: (a) Immediate exclusion of the employee from all food handling positions within the facility; and (b) Immediate closing of the food service facility until medical and epidemiological evidence shows that the likelihood of further foodborne disease transmission is low; and B. An investigation, a report, and the control of a foodborne disease outbreak is conducted in accordance with the provisions of COMAR 10.06.01. #### Regulation .37 Sampling, Detention, and Condemnation of Food. *COMAR 10.15.03.37* The approving authority shall: A. Sample and examine food as often as necessary for enforcement of this chapter; B. Sample food in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland; and C. Take action on a food in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland, by: (1) Issuing a detention order; (2) Destroying the food; or (3) Making the food unusable for consumption. #### Regulation .38 Penalties. *COMAR 10.15.03.38* A person who violates any of the provisions of this chapter or refuses, neglects, or fails to comply with the provisions and requirements of this chapter is subject to: A. Penalties, fines, and imprisonment as set forth in Health-General Article, §§21-1214 and 21-1215, Annotated Code of Maryland; and B. Penalties and fines as provided by local law, ordinance, or regulation in accordance with Health-General Article, §21-309.2(e)(3), Annotated Code of Maryland. #### Regulation .39 Federal Compliance. *COMAR 10.15.03.39* In addition to the other requirements set forth in this chapter, the person in charge shall ensure that the food service facility meets all of the requirements applicable to food sources, storage, preparation, and service that are set forth at: A. 21 CFR, as amended; B. 9 CFR, as amended; and C. 21 U.S.C. §343, as amended. #### Regulation .40 Micro Markets. *COMAR 10.15.03.40* A. The owner or operator of a micro market may not be required to have a person-in-charge present during the hours of operation of the micro market if the micro market meets the requirements of this regulation. B. Food sold at a micro market shall: (1) Be commercially prepackaged food or ready-to-eat food; (2) Be prepackaged in tamper-evident packaging; and (3) Contain all the following information on the packaging label: (a) Nutrition information required by the federal Food, Drug, and Cosmetic Act; (b) A freshness or expiration date; and (c) Any other information required by Maryland law. C. Refrigerated or frozen food sold at a micro market shall be stored and displayed in a refrigerator, refrigerated cooler, or freezer that: (1) Maintains an internal temperature of 41°F or lower; (2) Has self-closing doors; (3) Has doors that allow the food on display to be viewed without opening the door to the refrigerator, refrigerated cooler, or freezer; and (4) Has an automated self-locking feature that prevents a consumer from accessing the food on the occurrence of any condition that results in the failure of the refrigerator, refrigerated cooler, or freezer to maintain the internal temperature required under Regulation .06 of this chapter. D. Signage and Notice. The owner or operator of a micro market shall post a sign that is clearly visible to the consumer near the micro market entryway or while using the electronic payment device that includes the following information: (1) The name of the owner or operator of the micro market to whom complaints and comments regarding the micro market may be addressed; (2) The business mailing address of the owner or operator; (3) The business telephone number of the owner or operator; and (4) The email address and website address of the owner or operator, if applicable. E. Security. The owner or operator of a micro market: (1) May secure the products and premises of a micro market by the use of video surveillance that: (a) Operates 24 hours per day, 7 days per week; (b) Records consumers viewing, selecting, handling, and purchasing products from the micro market; and (c) Provides sufficient resolution to identify consumers described in §E(1)(b) of this regulation; and (2) Shall ensure that video surveillance recordings made under §E(1) of this regulation are: (a) Maintained by the owner for 14 days after the date of the video recording; and (b) Made available for inspection by the appropriate health or law enforcement agency on the request of the agency within 24 hours from the time the request is received by the owner or operator. F. Record Keeping. The owner or operator of a micro market shall ensure that: (1) In the event of a failure of an automated self-locking unit, records are kept for: (a) The repair or replacement of the failed unit in the form of receipts or a completed service order; and (b) All products in the unit at the time of the failure and include: (i) Product description; and (ii) Quantity of products discarded or destroyed; (2) Service receipts for the repair or replacement of the failed unit and product destruction shall be kept for a minimum of 90 days; and (3) All records are available for review upon request. ### Chapter 04 — Food and Drink Processing and Transportation **Authority:** Agriculture Article, §4-311; Health-General Article, §§18-102, 21-101, 21-102, 21-211, 21-234,21-301, 21-304, 21-308, 21-309.1, 21-309.2, and 21-336; Annotated Code of Maryland **Administrative History:** Effective date: November 18, 1960 **Administrative History:** Amended effective January 1, 1964; June 8, 1965; July 1, 1966; April 1, 1967; December 1, 1970 **Administrative History:** Regulation .29 adopted effective September 21, 1979 (6:19 Md. R. 1519) **Administrative History:** Regulation .29 amended effective December 14, 1979 (6:25 Md. R. 1980) **Administrative History:** Chapter revised as an emergency provision effective August 2, 1989 (16:17 Md. R. 1882); adopted permanently effective December 25, 1989 (16:25 Md. R. 2711) **Administrative History:** Regulation .01B amended effective September 28, 1992 (19:19 Md. R. 1708) **Administrative History:** Regulation .02B amended effective September 28, 1992 (19:19 Md. R. 1708); April 3, 2000 (27:6 Md. R. 641) **Administrative History:** Regulation .31 amended effective September 28, 1992 (19:19 Md. R. 1708) **Administrative History:** Regulation .33A amended effective March 4, 1991 (18:4 Md. R. 447); September 28, 1992 (19:19 Md. R. 1708); October 6, 1997 (24:20 Md. R. 1404) **Administrative History:** Regulations .01 — .37 repealed and new Regulations .01 — .20 adopted effective November 22, 2004 (31:23 Md. R. 1652) **Administrative History:** Regulation .02B amended effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .03B amended effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .08A amended effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .09B amended effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .10D amended effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .17A amended effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .19C, D amended effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .19G adopted effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .21 adopted effective May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Chapter revised as an emergency provision effective October 1, 2010 (37:23 Md. R. 1607); revised permanently effective January 24, 2011 (38:2 Md. R. 83) **Administrative History:** Regulation .02B amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163); February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .03B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .04 amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .05 amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .07B amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .08A amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .09D amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .13A amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .14 amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .14B amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .15A, D amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .16A amended effective March 5, 2012 (39:4 Md. R. 337); February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .17A amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .17D, E adopted effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .17E amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .18 amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Regulation .19A amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .20C, D amended effective March 5, 2012 (39:4 Md. R. 337); January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .20E adopted effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .20E adopted effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .22 repealed effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .23G amended effective January 6, 2014 (40:26 Md. R. 2163) **Administrative History:** Regulation .28C amended effective February 15, 2016 (43:3 Md. R. 272) **Administrative History:** Chapter revised effective August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation 15A, B, F amended effective January 5, 2026 (52:26 Md. R. 1309) **Administrative History:** Regulation .16A, C amended effective January 5, 2026 (52:26 Md. R. 1309) #### Regulation .01 Scope. *COMAR 10.15.04.01* This chapter: A. Provides the minimum food safety and sanitation requirements for food processing plants, including warehouses and transfer stations, and the transportation of food; B. Is not intended to govern a meat processing plant that solely processes meat products under the regulation and inspection of the United States Department of Agriculture in accordance with the Code of Federal Regulations. #### Regulation .02 Definitions. *COMAR 10.15.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Adulterated Food. (a) “Adulterated food” has the meaning stated in Health-General Article, §21-207, Annotated Code of Maryland. (b) “Adulterated food” includes food that is: (i) Is diseased; (ii) Is contaminated; (iii) Is filthy; (iv) Is putrid; (v) Has decomposed; (vi) Contains any poisonous or otherwise deleterious substance that, in the quantity present, reasonably would be expected to make it injurious to health; (vii) Contains any food additive or color additive, the particular use of which has not been found safe as provided under Health-General Article, §21-239, Annotated Code of Maryland; (viii) Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have contaminated it with filth; (ix) Was produced, prepared, packed, or held under unsanitary conditions that reasonably would be expected to have caused it to be diseased, unwholesome, or injurious to health; (x) Was packaged in a container composed of any poisonous or otherwise deleterious substance that reasonably would be expected to have caused the food to be injurious to health; or (xi) Is misbranded so that the food is unsafe for human consumption. (2) “Allergen cross-contact” means the unintentional incorporation of a food allergen into a food that has not been identified as containing it. (3) “Approving authority” means the agency designated in the laws of another state or country to license or permit a food processing plant. (4) “Approved source” means a source of food or food ingredients accepted by the Department because the food or food ingredients from the source: (a) Are not adulterated foods or misbranded as defined in §B(1) and (21) of this regulation; and (b) Where required, are regulated by the approving authority. (5) “Charity deer processing” means the processing of legally harvested whitetail deer into cuts of raw meat as only a service for a charitable organization that donates the meat to the needy for consumption. (6) “Contamination” means the process or state that potentially renders a food unsafe for human consumption due to the adulteration of the food with: (a) Pathogens; (b) Chemicals; (c) Allergens; (d) Foreign objects; or (e) Filth. (7) “Corrective action” means the documented steps taken when a deviation occurs at a control point to: (a) Address the cause of the deviation; (b) Restore control; and (c) Prevent the affected food from entering commerce. (8) “Critical control point” means a step or procedure in a food process at which control can be applied, and is essential to: (a) Prevent a food safety hazard; (b) Eliminate a food safety hazard; or (c) Reduce a hazard to an acceptable level. (9) Critical Item. (a) “Critical item” means a food safety requirement that if violated requires: (i) Immediate correction; (ii) The cessation of some or all processing operations; or (iii) Plant closure. (b) “Critical item” includes the following requirements: (i) Food is obtained from an approved source; (ii) Food is protected from contamination and allergen cross-contact; (iii) Food processes provide safe food with proper control at critical control points; (iv) Food is protected by ensuring that all personnel wash hands thoroughly as often as necessary to prevent food contamination by hand contact; (v) Personnel are restricted from food handling positions or the plant as indicated if they have an illness or infection that is transmissible through food as defined in COMAR 10.06.01.06E; (vi) Food is packaged and labeled for safety with allergens properly identified on the label; (vii) A sufficient volume of potable hot and cold water supply under pressure is available; and (viii) Sewage is discharged in compliance with applicable laws and regulations. (10) “Department” means the Maryland Department of Health or the Department's designee. (11) Farm. (a) “Farm” means a place where agricultural commodities are grown, raised, or harvested for commercial purposes. (b) “Farm” includes a place where, for commercial purposes: (i) Crops are grown and harvested; (ii) Fruit, nuts, or other agricultural commodities are harvested from trees; or (iii) Animals are raised, fed, and managed for meat or other agricultural commodities. (12) “Food” means: (a) Articles used for food or drink for humans or other animals; (b) Chewing gum; and (c) Individual components of such articles. (13) “Food allergen” means an ingredient that contains protein derived from one of the following foods or food groups: (a) Milk; (b) Egg; (c) Fish; (d) Crustacean shellfish; (e) Tree nuts; (f) Wheat; (g) Peanuts; (h) Soybeans; or (i) Sesame. (14) Food Processing Plant. (a) “Food processing plant” means a place used for or in connection with commercial food: (i) Manufacturing; (ii) Processing; (iii) Packing; (iv) Repacking; (v) Storage; or (vi) Distribution. (b) “Food processing plant” includes a: (i) Crab meat picking plant; (ii) Food manufacturing plant; (iii) Cold food warehouse; (iv) Ambient food warehouse, except as specified in §B(14)(c) of this regulation; (v) Shellfish plant or dealer; (vi) Bottled water plant; (vii) Meat processing plant or poultry processing plant that is not subject to regulation by the United States Department of Agriculture or by a meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture; (viii) Cider plant; (ix) Charity deer processing plant; and (x) Producer mobile farmer’s market unit. (c) “Food processing plant” does not include a warehouse or distribution center that: (i) Stores only sealed containers pre-packaged, ready-to-eat snack foods that do not require temperature control for safety; (ii) Stores only bottled beverages that do not require temperature control for safety; (iii) Stores only packaged ice; (iv) Stores only whole bean, ground or instant coffee, or leaf or instant teas; (v) Stores only nondairy dehydrated whiteners, sugar, or sugar-free sweeteners; or (vi) Is a food transfer station where food is transferred between transportation vehicles or there is an area maintained for food that is stored for less than 24 hours. (15) “Generally recognized as safe (GRAS)” means that a substance is: (a) Not harmful to humans consuming the substance under the intended conditions of use; and (b) In accordance with 21 CFR §170.30. (16) “Hazard” means any biological, chemical (including radiological), or physical agent that has the potential to cause illness or injury (17) “Hazard Analysis Critical Control Point (HACCP)” means a management system that addresses the safety of food that is temperature controlled for safety (TCS) at critical control points as specified by: (a) COMAR 10.15.10 Procedures for the Safe Handling and Processing of Seafood; (b) COMAR 10.15.12 Procedures for the Safe Handling and Processing of Juice; (c) 21 CFR Part 123 Fish and Fishery Products; or (d) The National Advisory Committee on the Microbiological Criteria for Food. (18) “Indirect food additive” means a substance that is unintentionally incorporated into food due to processing, holding, or packaging. (19) “Label” means a display of written or graphic matter on the container, other than the package liner, of a food. (20) “Labeling” means any label or other written or graphic material that: (a) Is on a: (i) Food; (ii) Food container; or (iii) Food wrapping; or (b) Accompanies a food. (21) “Misbranded” has the meaning stated in Health-General Article, §21-210, Annotated Code of Maryland. (22) “Person-in-charge” means: (a) The licensee; or (b) Another person responsible for the operation of the food processing plant. (23) “Potable water” means a water supply that meets the requirements of the Safe Drinking Water Act, as administered by the EPA and COMAR 26.04.02.01B(33). (24) “Poultry” means any domesticated bird. (25) Preventive Controls. (a) “Preventive controls” means a step or combination of steps that are taken to minimize, prevent, or eliminate: (i) Identified food safety hazards; or (ii) Food safety hazards that are reasonably likely to occur. (b) “Preventive controls” includes: (i) Process controls; (ii) Allergen controls; (iii) Sanitation controls; and (iv) Other appropriate controls taken at critical control points or at other points as necessary to ensure food safety based on the outcome of a hazard analysis. (26) “Preventive controls qualified individual (PCQI)” means an individual who has: (a) Successfully completed training in the development and application of risk-based preventive controls; or (b) The education, experience, and knowledge to develop and implement a food safety system. (27) “Principal display panel” means the part of a label that is the most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. (28) “Process” means a specific set of operations or procedures used to manufacture a food. (29) “Process authority” means an individual having expert knowledge of specialized food processes acquired through : (a) Training; and (b) Experience. (30) Producer Mobile Farmer’s Market Unit. (a) “Producer mobile farmer’s market unit” means a unit designed to ensure that food is: (i) Protected from contamination during transportation from farm to farmer’s market or public festival or event; and (ii) Kept at temperatures that support the safety and wholesomeness of the food. (b) “Producer mobile farmer’s market unit” does not include a unit used to deliver: (i) Prepackaged foods to fill an order of a customer; (ii) Raw agricultural products; or (iii) On-farm home processed foods that do not require temperature control for safety. (31) “Qualified auditor” means a qualified individual with necessary technical expertise regarding hazards being controlled to evaluate food safety regulations and review a supplier’s written plan, for example, the Hazard Analysis and Critical Control Point (HACCP) plan or other food safety plan, and its implementation through: (a) Education; (b) Training; or (c) Experience. (32) “Qualified individual” means a person who is able to handle food safely as appropriate to the individual’s assigned duties, as determined by having the: (a) Education; (b) Training; or (c) Experience. (33) “Scheduled process means a method or set of procedures established by a process authority for processing a food, includes the critical factors that may impact the food’s safety or stability to achieve and maintain a food that will not permit the growth of microorganisms having public health significance. (34) “Shelf life study” means a food evaluation using microbiological, physical, chemical, organoleptic, or other tests to determine the length of time a food may be stored before the food becomes unfit for sale or human consumption. (35) “Shell eggs” means raw or treated eggs produced by poultry for human consumption. (36) “Snack foods” means chips, pretzels, candy, and other novelty snacks. (37) “Temperature control for safety (TCS)” means a food requires specific time and temperature control to limit pathogenic microorganism growth or toxin formation for safety. #### Regulation .03 Incorporation by Reference. *COMAR 10.15.04.03* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) 9 CFR, as amended; (2) 21 CFR, as amended; (3) 21 U.S.C. §343, as amended; (4) 21 U.S.C. §§451 — 471, as amended; and (5) 21 U.S.C. §§601 — 695, as amended. #### Regulation .04 Compliance with Other Chapters. *COMAR 10.15.04.04* The person-in-charge shall manufacture, process, pack/repack, label, store, or distribute food and design, operate, and maintain a food processing plant and the facilities and equipment associated with a food processing plant in compliance with this chapter and with COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, and 10.15.12, as applicable. #### Regulation .05 Personnel. *COMAR 10.15.04.05* The person-in-charge shall ensure that: A. Individuals do not cause contamination of: (1) Food; (2) Food-contact surfaces; and (3) Food-packaging material; B. Individuals are excluded from working with food, food-contact surfaces, and food-packaging materials: (1) As provided in COMAR 10.06.01.06E; and (2) When an individual has an: (a) Illness transmissible through food; or (b) Exposed and open sore or cut; C. Individuals working in direct contact with food, food-contact surfaces, and food-packaging material: (1) Wear suitable, clean outerwear garments in a manner that protects the food, food-contact surfaces, and food-packaging material against contamination; (2) Wear hair nets, beard covers, or other effective hair restraints; (3) Keep fingernails clean and neatly trimmed; (4) Prevent fingernail polish or artificial fingernails from coming into contact with food, food-contact surfaces, and food-packaging material; (5) Remove all unsecured jewelry and other objects that may fall into food, equipment, or containers; (6) Secure any jewelry that cannot be removed with material which can be maintained in an intact, clean, and sanitary condition; (7) Wash hands and exposed arm areas thoroughly with soap and warm water: (a) At a hand washing facility in compliance with regulation .12G of this chapter; (b) Before starting work; (c) After each absence from the workstation; and (d) At any other time when hands may have become soiled or contaminated or as often as required to remove soil and contamination; and (8) Apply sanitizer as necessary to protect against contamination with undesirable microorganisms; D. Individuals wearing gloves while working with food or food-contact surfaces shall: (1) Use gloves that are intended for food contact; (2) Maintain gloves in an intact, clean, and sanitary condition; (3) Wash hands thoroughly before putting on gloves; (4) Clean and sanitize reusable gloves using approved methods or equipment. (5) Replace gloves: (a) When the gloves are damaged or soiled; (b) Between unrelated tasks; and (c) After an interruption in working with food or food-contact surfaces; E. Individuals store personal items in a designated area other than where food is exposed or stored, or where equipment or utensils are washed; F. Individuals do not use tobacco, chew gum, eat food, drink beverages, or engage in any activity that might contaminate food in an area that is used for: (1) Food processing; (2) Equipment or utensil washing; (3) Storage of: (a) Food; (b) Food-contact surfaces; or (c) Food packaging; G. Individuals prevent allergen cross-contact and contamination with microorganisms, deleterious substances, or foreign matter of food, food-contact surfaces, and food-packaging materials; H. Education and training in personal hygiene, food handling, and plant sanitation is provided to personnel, food handlers, and supervisors in a language and form they understand as it relates to assigned duties such that: (1) Each individual engaged in food handling or in the supervision of one or more individuals be qualified by: (a) Education; (b) Training; (c) Experience; or (d) A combination of education, training, and experience; (2) Responsibility for education and training shall be clearly assigned to qualified supervisory personnel; and (3) Records that document each individual’s training are maintained according to Regulation .06 of this chapter; and I. When specialized personnel training is required by COMAR 10.15.01, 10.15.02, 10.15.07, 10.15.10, or 10.15.12 or this chapter, or 21 CFR Part 112, Subpart M, the specialized training is obtained as required. #### Regulation .06 General Record Keeping. *COMAR 10.15.04.06* The person-in-charge shall ensure that all required records: A. Be kept as original records, true copies, or electronic records; B. Identify the name and location of the food processing plant; C. Contain the time and date the activity was performed and documented; D. Include the signature or initials of the individual performing and documenting the activity; E. Contain actual values and observations obtained during monitoring and verification activities; F. Be accurate, indelible, and legible; G. Be created concurrently with performance of the activity documented; H. Be as detailed as necessary to provide a history of work performed; I. Identify the product and lot code if applicable; J. Are original or accurate reproductions of the original and are retained at the plant or facility for at least 2 years after the date they were prepared; and K. Are made available to an authorized representative of the Department for official review and reproduction upon oral or written request. #### Regulation .07 Food Protection, Processes, and Controls. *COMAR 10.15.04.07* The person-in-charge shall ensure that: A. All food and food ingredients processed in a food processing plant: (1) Are from an approved source; (2) Are GRAS; (3) If applicable, conform to a standard of identity, as defined in 21 CFR Part 130; (4) Comply with FDA regulations for poisonous or deleterious substances; and (5) Are identified and held in a manner that prevents allergen cross-contact if the food and food ingredients are an allergen or contain an allergen; B. When ice is used in contact with food, it shall be: (1) Made from potable water; and (2) Manufactured and stored in accordance with this chapter; C. Compressed air or other gasses mechanically introduced into food do not contaminate the food with unlawful indirect food additives; D. Raw materials and other ingredients: (1) Are inspected at receipt to ensure that they are acceptable for use; and (2) Are washed or cleaned as necessary to remove soil or other contamination; E. Food is processed and stored under conditions and control procedures that prevent and protect from: (1) Contamination; and (2) Allergen cross-contact; F. The potential for contamination and allergen cross-contact is reduced by: (1) Food safety controls; (2) Operating practices; and (3) Separation of operations by: (a) Location; (b) Time; or (c) Effective design; G. Food is processed and stored at temperatures that: (1) Minimize the potential for the growth of microorganisms; and (2) Prevent adulteration; H. The thermal processing of food eliminates or reduces the number of pathogens in the food so that the food is safe for human consumption; I. The cooling of foods is conducted using methods that: (1) Minimize the potential for the growth of microorganisms; and (2) Prevent adulteration; J. Foods that require temperature control for safety are maintained at the temperature: (1) 38°F or less for foods with a non-proteolytic Clostridium botulinum potential hazard; (2) 40°F or less; (3) 45°F or less for molluscan shellfish or shell eggs; (4) 135°F or higher; or (5) As otherwise approved by the Department; K. Food that relies principally on the control of aw for preventing the growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level; L. Food that relies principally on the control of pH for preventing the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below; M. Adequate measures are taken to protect against the inclusion of metal or other extraneous material in food; N. Frozen food remains frozen when stored or removed from refrigeration in order to be segregated, organized, or moved; O. Frozen foods are thawed in a manner that prevents contamination; P. Any food, raw material, or ingredient that is adulterated is not offered to human beings and is: (1) Rejected upon receipt; (2) Treated or processed to eliminate the contamination; (3) Destroyed in a manner that protects against the contamination and allergen cross-contact of other food; (4) Stored only in a designated area that is: (a) Separated from all other food and food process operations; and (b) Conspicuously marked with the intended disposition; (5) Reconditioned using a method that is safe and effective; (6) Reexamined following reconditioning and subsequently found not to be adulterated; (7) Not mixed with another lot of food that is not adulterated; and (8) If detained by the Department: (a) Reconditioned; or (b) Destroyed in a manner approved by the Department; Q. A facility that only stores unexposed packaged foods that require time and temperature control to significantly minimize or prevent pathogens: (1) Establishes and implements temperature controls that significantly minimize or prevent the growth of, or toxin production by, pathogens; (2) Monitors the temperature controls with adequate frequency; (3) Takes appropriate corrective actions if there is a loss of temperature control that may impact the safety of the food; (4) Establishes and maintains affirmative or exception records that document implementation of temperature controls, calibration, or accuracy checks of temperature monitoring and recording devices, and corrective actions; (5) Reviews records of monitoring and corrective actions taken to correct a problem with the control of temperature within: (a) 7 working days after the records are created; or (b) A reasonable time frame; and (6) Reviews records of calibration or accuracy checks within a reasonable time frame after the records are created; R. Written standard operating procedures are: (1) Available to employees in a format they understand; (2) Implemented; and (3) Reflective of current manufacturing procedures; S. When the Department requires a scheduled process, the scheduled process is: (1) Established by a process authority; (2) Used to manufacture the target food; (3) Not changed without approval of the process authority; (4) Documented by: (a) Production records; and (b) Process deviation records; and (5) Verified by: (a) Production records review; (b) Equipment calibration; or (c) Laboratory testing; T. Records that document compliance with this regulation are maintained in accordance with Regulation .06 of this chapter; U. Human food by-products for use or distribution as animal food without additional manufacturing or processing are: (1) Accurately identified when stored; (2) Stored under conditions that protect against contamination; and (3) Labeled or accompanied by a label identifying the by-product by the common or usual name when distributed; V. Finished product testing for chemicals, microbes, or extraneous materials is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact; and W. Environmental testing for chemicals or microbes is conducted when necessary to identify failures to protect ready to eat food from contamination or allergen cross-contact. #### Regulation .08 Hazard Analysis and Risk-Based Preventive Controls. *COMAR 10.15.04.08* The person-in-charge: A. Is exempt from this regulation if: (1) They meet the definition of a qualified facility in 21 CFR §117.3; or (2) They meet the qualifications defined in: (a) 21 CFR §§117.5—117.8; (b) 21 CFR §117.201; (c) 21 CFR §§117.251—117.287; and (d) 21 CFR §117.315(a)(2); B. Shall ensure that a food safety plan: (1) Is prepared, implemented, and managed by one or more individuals qualified in preventative controls; (2) Is signed and dated by the owner, operator, or agent in charge: (a) Upon initial completion; (b) When any modification takes place; and (c) At least once every 3 years; (3) Includes a written hazard analysis that identifies all known and reasonably likely to occur biological, chemical, and physical hazards associated with each type of food manufactured in the plant; (4) Includes written procedures for: (a) Preventive controls; (b) Process controls with parameters and values; (c) Allergen controls; (d) Sanitation controls; (e) Other controls necessary as identified in the hazard analysis; (f) Monitoring and record keeping for each preventive control identified in the hazard analysis that include an adequate frequency to control the hazard; (g) Corrective actions that: (i) Identify and correct the problem; (ii) Reduce the likelihood the problem will recur; (iii) Evaluate all affected food for safety; and (iv) Prevent all affected food from entering commerce; (h) Verification activities that ensure that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards; (i) Validation for process controls; (j) A supply chain program that complies with 21 CFR §§117.405—117.475 if the receiving facility has identified a hazard requiring a supply-chain-applied control; and (k) A recall plan for a food with a hazard requiring a preventive control, that includes: (i) Maintaining accurate records to identify the initial distribution of the food; (ii) Direct notification of the consignees of the food being recalled, including how to return or dispose of the affected food; (iii) Public notification about any hazard presented by the food when appropriate to protect public health; and (iv) Effectiveness checks to account for all products affected; (5) Is implemented to prevent, eliminate, or reduce to an acceptable level, all identified hazards; (6) Includes records that document implementation of: (a) The food safety plan monitoring; (b) Corrective actions; and (c) Supply chain, verification, validation, and applicable training for the preventive controls qualified individual and the qualified auditor; (7) Includes that records of monitoring and corrective actions are reviewed by a preventive controls qualified individual within 7 working days after the records are created, or within a reasonable time frame; and (8) Includes that records of verification activities are reviewed within a reasonable time by a preventive controls qualified individual; and C. Shall ensure that a processing plant complies with the 21 CFR §§117.136—117.137 and 117.335 if results of the hazard analysis determine the facility is not required to implement preventive controls for a food item. #### Regulation .09 Plant and Grounds. *COMAR 10.15.04.09* The person-in-charge shall ensure that: A. The food processing plant and grounds around a food processing plant are: (1) Maintained free of attractants, breeding places, or harborage for pests and insects, including: (a) Unused equipment; (b) Debris; (c) Litter; (d) Waste; or (e) High weeds or grass; and (2) Adequately drained to promote sanitation and prevent breeding places for pests and insects; B. The design and construction of the plant facilitates maintenance and sanitary operations for food processing and: (1) Is suitable in size; (2) Affords protection against the weather; and (3) Minimizes the potential for contamination and allergen cross-contact by providing: (a) Adequate space for the placement of: (i) Equipment; (ii) Utensils; and (iii) Materials storage; and (b) Effective designing the flow of food through the plant; C. Except as provided for in Regulation .15 of this chapter, a room or area in which food is processed or stored or in which utensils, equipment, or food-packaging materials are cleaned, sanitized, or stored: (1) Is separated from other rooms or areas in the plant to preclude allergen cross-contact and contamination by: (a) A distance that precludes allergen cross-contact and contamination; or (b) Tight fitting: (i) Walls; (ii) Ceilings; and (iii) Self-closing doors; (2) Is, if not refrigerated, mechanically ventilated using exhaust and supply fans to ensure: (a) Filtered air is supplied to provide a positive air pressure in the room; (b) Condensation and grease do not accumulate on room surfaces and equipment; and (c) Removal of excessive: (i) Grease vapors; (ii) Steam; (iii) Heat; and (iv) Odors; (3) Has a floor, walls, and ceiling that are: (a) Smooth; (b) Washable; (c) Easily cleanable; and (d) Impervious to water; (4) Has only the exposed overhead pipes, ducts, conduits, evaporators, and other structures that are needed for proper processing, which are installed so that food is protected against leakage; (5) Has floor-wall junctures that are: (a) Coved; and (b) Impervious to water; (6) Has aisles or working spaces between equipment and walls that: (a) Are unobstructed; (b) Of adequate width to permit employees to perform their duties; and (c) Protect against the contamination of food, food-contact surfaces, or food-packaging materials by clothing or personal contact; (7) Provides adequate lighting in all areas that: (a) Uses shatter-resistant light bulbs, fixtures, skylights, or other light sources if suspended over exposed food, food-contact surfaces, or food-packaging materials in any step of preparation; or (b) Otherwise protects against food contamination in case of glass breakage; and (8) Has well-maintained, sealed walls, floors, and ceilings to prevent entry or harborage areas for pests; D. Except as provided for in Regulation .15 of this chapter, an area is designated for employees to eat, drink, and securely store personal items which is separate from areas designated for the cleaning, sanitation, or storage of: (1) Utensils; (2) Equipment; or (3) Food-packaging materials; E. The food processing plant is completely separated by solid, impervious floors, walls, and ceilings with no connecting openings from areas used as living quarters; and F. Plans provided for review to the Department of the plant, facilities, and grounds design and construction that are not provided for in this regulation: (1) Provide for adequate food safety, food protection, and sanitation; and (2) Are equivalent to regulatory and industry standards. #### Regulation .10 Equipment and Utensils. *COMAR 10.15.04.10* The person-in-charge shall ensure that: A. Except as provided in §§B and M of this regulation, equipment and utensils meet one or more of the following sanitation design standards: (1) National Sanitation Foundation (NSF); (2) The ETL SEMKO division of Intertek Group PLC (Intertek ETL SEMKO); (3) Canadian Standards Association (CSA); (4) Underwriters Laboratories (UL); (5) Bakery Industry Sanitation Standards Committee; (6) National Automatic Merchandising Association; (7) International Association of Food Protection; (8) American Society of Mechanical Engineers; (9) U.S. Department of Agriculture; or (10) Another applicable published standard acceptable to the Department; B. When design standards conflict with State laws, codes, or regulations, the State laws, codes, or regulations are followed; C. Food processing equipment and utensils are: (1) Designed and constructed to allow for adequate cleaning and sanitizing; (2) Installed in a way to facilitate cleaning, sanitizing, and maintenance of the equipment and the surrounding areas, including equipment that does not come in contact with food; (3) Designed and constructed to prevent contamination and allergen cross-contact; and (4) Maintained in: (a) Proper working condition; and (b) A manner that protects against contamination and allergen cross-contact; D. Each freezer and cold storage unit used to store and transport food capable of supporting growth of microorganisms: (1) Maintains temperatures that ensure food safety and protect against spoilage; (2) Is fitted with an indicating thermometer, temperature-measuring device, or temperature-recording device that is: (a) Calibrated to be accurate to within plus or minus 2°F; and (b) Placed in a conspicuous location to show the temperature accurately within the unit; E. All food-contact surfaces are designed, constructed, and maintained to be: (1) Smooth; (2) Easily cleanable; (3) Durable; (4) Non-absorbent; (5) Constructed of food grade material where applicable; (6) Corrosion resistant; (7) Made of nontoxic material that does not impart toxic or deleterious matter to the food; (8) Inert to food and do not migrate into or adulterate food; and (9) Smoothly bonded at the seams and maintained to minimize accumulation of: (a) Food particles; (b) Dirt; and (c) Organic matter; F. Food-packaging material: (1) Is food grade; (2) Is safe; (3) Is able to maintain food safety and integrity; (4) Is appropriate for the food item and the intended use; (5) Is not reused if intended for single-service; (6) Meets the labeling requirements in Regulation .13B(2) of this chapter; (7) Does not migrate to or have the potential to be absorbed by food; and (8) Complies with the requirements of the U.S. Food and Drug Administration in 21 CFR Parts 174—178 for indirect food additives; G. Instruments and controls required for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control or prevent the growth of undesirable microorganisms in food are accurate and adequate in number for their designated uses; H. Thermometers used to monitor required temperatures are calibrated or checked for accuracy annually using an approved method; I. Compressed air or other gasses mechanically used to clean food-contact surfaces or equipment are treated in such a way that food is not contaminated with unlawful indirect food additives; J. Non-food-contact equipment is: (1) Smooth; (2) Easily cleanable; (3) Durable; and (4) Non-absorbent; K. The food storage area of a transportation vehicle is maintained in: (1) Good repair; (2) Working condition; and (3) A manner that protects against contamination of food; L. Containers, equipment, and vehicles used to convey or hold human food by-products for use as animal food are designed and constructed of appropriate material to protect against contamination; and M. Equipment submitted to the approving authority for review that meets the provisions of §§C—E of this regulation but fails to comply with §A of this regulation is: (1) Not harmful to public health; and (2) Consistent with industry standards and practice. #### Regulation .11 Sanitary Operation. *COMAR 10.15.04.11* The person-in-charge shall ensure that: A. All food processing, food storage, and food-packaging storage areas are maintained in a clean and sanitary manner; B. Equipment is used and maintained to avoid contamination and allergen cross-contact of food; C. Food-packaging material is stored to be protected from contamination; D. Overall sanitation of the plant is under the supervision of one or more qualified individuals; E. The equipment and facilities needed for cleaning and sanitizing food-contact surfaces are provided and maintained in a sanitary condition; F. Cleaning and sanitizing of plant facilities, equipment, and utensils are conducted in a manner that protects against allergen cross-contact and against contamination of: (1) Food; (2) Food-contact surfaces; and (3) Food-packaging materials; G. All food-contact surfaces are cleaned and sanitized as frequently as necessary to protect against allergen cross-contact and against contamination of food; H. Before use, food-contact surfaces used for processing or holding low-moisture food are: (1) Clean; (2) Dry; and (3) Sanitary; I. Food-contact surfaces are cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have become contaminated; J. When equipment and utensils are washed, rinsed, and sanitized using a three-compartment sink: (1) Each sink compartment is sized to allow sufficient immersion of the equipment or utensils; and (2) The washed, rinsed, and sanitized items are dry before stacking or nesting; K. Non-food-contact surfaces of equipment used in the operation of a food plant are cleaned as frequently as necessary to be maintained in a sanitary condition; L. Cleaned equipment and utensils are stored to prevent contamination of the equipment and utensils; M. Toxic chemicals, cleaning compounds, sanitizing agents, and pesticide chemicals used in the facility are: (1) Safe and adequate under the conditions of use; (2) Used in accordance with the manufacturer’s instructions and applicable State laws and regulations; and (3) Identified and stored in a manner that protects against contaminating: (a) Food; (b) Food-contact surfaces; or (c) Food-packaging materials; N. All processing and storage areas are maintained free of pests; O. Effective measures are taken to: (1) Monitor for and exclude pests from processing and storage areas; and (2) Protect against the contamination of food by pests; P. The food storage area of a transportation vehicle is: (1) Maintained in a clean and sanitary condition; and (2) Inspected as often as necessary to maintain it in a clean and sanitary condition; Q. Containers, equipment, and vehicles used to convey or hold human food by-products for use as animal food before distribution are: (1) Cleaned as necessary; (2) Examined prior to use to protect against contamination from the container or vehicle; and (3) Maintained to protect against contamination; and R. If ready-to-eat foods are processed, environmental testing is conducted when necessary to demonstrate effectiveness of sanitation operations. #### Regulation .12 Sanitary Facilities and Controls. *COMAR 10.15.04.12* The person-in-charge shall ensure that: A. The water supply is adequate for the operations intended and is: (1) From an approved potable source; (2) At an adequate temperature; (3) Under adequate pressure; and (4) Protected against backflow; B. All plumbing is of adequate size and is designed, installed, and maintained to: (1) Carry adequate quantities of water to required locations throughout the plant; (2) Convey sewage and liquid waste from the plant; (3) Prevent contamination of: (a) Food; (b) Water supplies; (c) Equipment; (d) Utensils; and (e) Food-packaging materials; (4) Ensure sanitary conditions; (5) Prevent backflow from, or cross-connection between, piping systems that carry wastewater and potable water; and (6) Be in compliance with State and local codes; C. Adequate floor drainage is provided in all areas where: (1) Floors are subject to water accumulation during cleaning; or (2) Normal operations release or discharge water or other liquid waste on the floor; D. Floors are sloped to floor drains to prevent water accumulation and ponding; E. Sewage and wastewater is discharged: (1) In compliance with applicable laws and regulations; (2) Into a sewage disposal system that meets all applicable State and local codes; or (3) Through other acceptable means approved by the Department; F. Toilet facilities: (1) Are readily accessible and adequate in number for employee use; (2) Are kept clean and are not a potential source of contamination of: (a) Food; (b) Food-contact surfaces; and (c) Food-packaging materials; and (3) Are provided with: (a) Signage that instructs individuals to wash their hands before returning to work; (b) Mechanical air exhaust and intake of an equal amount of makeup air at the rate of 2 cubic feet per minute of air for each square foot of floor area or a screened window that allows the adequate exchange of outside air; (c) Floors, walls, and a ceiling that are: (i) Smooth; (ii) Washable; (iii) Easily cleanable; and (iv) Impervious to water; (d) Floor-wall junctures that are sealed to be impervious to water; (e) Adequate lighting; and (f) Hand washing facilities as specified in §G of this regulation; G. Hand washing facilities: (1) Are provided that are adequate in number and conveniently located in areas where food is processed or equipment or utensils are washed and sanitized; and (2) Are supplied with: (a) Soap; (b) Warm water of sufficient volume, under pressure for effective hand washing; (c) Paper towels or warm air hand drying device; (d) A conveniently located trash receptacle; and (e) Hand sanitizer, if necessary to protect against contamination; and H. Solid waste: (1) Is handled and disposed of using waste containers that are: (a) Adequate in number and size to maintain sanitary conditions; (b) Conveniently located where waste is generated; (c) Easily cleanable; (d) Leak proof; and (e) Emptied and cleaned at a frequency that maintains sanitary conditions; and (2) Is handled, stored, and disposed of in a manner that: (a) Minimizes the development of odors; (b) Minimizes the potential for becoming an attractant or harborage for pests; (c) Meets all applicable State and local codes; and (d) Protects against contamination of: (i) Food; (ii) Food-contact surfaces; (iii) Food-packaging materials; (iv) Water supplies; and (v) Plant and grounds. #### Regulation .13 Labeling. *COMAR 10.15.04.13* A. In accordance with Health-General Article, §21-212, Annotated Code of Maryland, a federal rule that exempts a food from label requirements is effective automatically in the State. B. The person-in-charge shall ensure that: (1) Except as provided in §A of this regulation, food labeling meets the requirements in 21 CFR Part 101; (2) Except as provided in §A of this regulation, the following information is provided on a label of food in packaged form: (a) Common or usual name of the food; (b) Statement of ingredients that gives the common or usual names of the ingredients in descending order of prominence with sub-ingredients listed; (c) Name and address of the manufacturer or distributor with: (i) The full street address including the zip code of the manufacturer or distributor if the address is not listed on a website, current city directory, or telephone directory; or (ii) A minimum of the town and zip code if the manufacturer or distributor is listed on a website, current city directory, or telephone directory; (d) Net quantity in terms of: (i) Weight in U.S. Customary units and equivalent metric units; (ii) Fluid measure in U.S. Customary units and equivalent metric units; (iii) Numerical count; or (iv) Combination of numerical count and weight; (e) If a food coloring has been added, the food coloring in the statement of ingredients; (f) If a chemical preservative has been added, a label declaration stating: (i) The common or usual name of the ingredient; and (ii) A separate description of its function such as “preservative” or “mold inhibitor”; (g) Major food allergens in accordance with 21 U.S.C. §343(w); (h) For a food that requires refrigeration for safety, the words “keep refrigerated” or equivalent; (i) For a food that requires refrigeration for safety after the food’s packaging is opened, the words “refrigerate after opening” or equivalent; (j) For a food that is frozen for safety or quality, the words “keep frozen” or equivalent; (k) A “use by date” if the package contains a food whose safety is assured only until the date specified on the label; (l) For a food that is frozen during processing or after processing and then thawed before being offered for human consumption, the words “previously frozen, should not refreeze”; and (m) The exact words “WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.” for a juice product that has not been processed in accordance with COMAR 10.15.12; (3) A food label and the labeling information in §B(1) of this regulation are: (a) Durable; (b) Conspicuous; (c) Legible; (d) Able to remain on a container for the shelf life of the food; and (e) Placed on the food container by: (i) Imprinting; (ii) Embossing; (iii) Lithography; (iv) Ink jetting; or (v) Another method set forth in 21 CFR Parts 100 and 101 or in conformance with §B(2) of this regulation; (4) The information required in §B(2) of this regulation is located on the principal display panel; (5) If the food is not manufactured by the business whose name appears on the label, the business name is qualified by a phrase that reveals the connection the business has with the food, such as “Manufactured for” or “Distributed by”; (6) If the address given on the label is not the place where the food was actually manufactured, packaged, or distributed, it is the address of the principal place of business of the manufacturer or distributor given on the label; (7) A food’s labeling or packaging is not false or misleading in any way; and (8) A food that has been frozen or thermally processed is not labeled “fresh”. C. The person-in-charge may forego: (1) Declaring on the label the common or usual name of each ingredient for incidental additives that: (a) Have no technical or functional effect in the food; and (b) Are not required by a federal rule to be declared; and (2) Complying with the requirements in §B(2)(a)—(f) and (j) of this regulation for a shipment of food that, in accordance with the practice of trade, is processed, labeled, or repacked in substantial quantity at an establishment other than where originally processed or packed if: (a) The person who introduced the shipment of food into interstate commerce is the operator of the establishment where the food is to be processed, labeled, or repacked; or (b) The shipment or delivery to the establishment is made under a written agreement as set forth in 21 CFR §101.100(d). #### Regulation .14 Facility Process and Plan Review. *COMAR 10.15.04.14* A. The person-in-charge shall ensure that plans and specifications are submitted to the Department: (1) Before: (a) A food processing plant is: (i) Constructed; (ii) Remodeled; or (iii) Materially altered; (b) An existing building or structure is converted or remodeled for use as a food processing plant; (c) A food or process is added or significantly modified; or (d) A new scheduled process or shelf life study is used; and (2) That include the following information, as applicable: (a) A scale drawing in horizontal view that identifies the: (i) Layout and arrangement of work areas; (ii) Location of food equipment including exhaust ventilation hoods; and (iii) Location of plumbing and plumbing fixtures such as water lines, sewer lines, hand sinks, toilets, utility sinks, utensil washing sinks, floor drains, floor sinks, and hose stations; (b) Specifications for the: (i) Construction materials for the building and interior finishes; (ii) Disposal of sewage; (iii) Provision of potable water; (iv) Exclusion and control of pests; (v) Ventilation of the plant and individual areas within the plant; (vi) Methods and facilities for waste storage and disposal; and (vii) Lighting; (c) A complete list of specifications for the proposed equipment; (d) A written description of the foods to be processed, stored, or distributed; (e) Written standard operating procedures for: (i) Processing foods named in §A(2)(d) of this regulation; (ii) Employee health and personal hygiene; and (iii) Plant sanitation; (f) When required by Regulation .02, .07, .10, or .12 of this chapter, a HACCP plan; (g) When required by the Department, a scheduled process or shelf life study, performed by a process authority; (h) When required by the Department, a laboratory analysis, performed by a laboratory with a current accreditation to the ISO/IEC 17025; (i) A hazard analysis and food safety plan as required by Regulation .08B and C of this chapter; and (j) Any other information that may be required by the Department to ascertain compliance of the plans and specifications with all applicable federal, State and local laws, regulations, and ordinances. B. The person-in-charge may not construct a new food processing plant, remodel an existing food processing plant, or manufacture a food using a new or modified process before receiving written approval of the plans and specifications from the Department. C. The Department shall: (1) Review the plans and specifications to ensure compliance with the applicable regulations; (2) Inform in writing the individual who submitted the plans and specifications: (a) Of additional information that may be required; and (b) Following the review, whether the plans and specifications are approved or denied; and (3) If the plans are denied, provide the individual in writing who submitted the plans and specifications with information on how to appeal the decision, as set forth in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. D. The person-in-charge shall ensure that before a new or remodeled food processing plant is operated: (1) The Department schedules and completes an inspection; (2) The Department issues written approval for the use of the new or remodeled plant; and (3) For a new plant, a food processing license is obtained. E. The Department shall: (1) Review the plans and specifications to ensure compliance with the applicable regulations; (2) Conduct a priority assessment of the facility based on the information obtained pursuant to §A(2)(d) and (e) of this regulation; and (3) Classify a food processing plant as a: (a) High priority facility, if the food processing plant manufactures food: (i) Using specialized processes that require a scheduled process or a HACCP Plan; (ii) Using ingredients that require temperature control for safety; or (iii) That is temperature controlled for safety; (b) Moderate priority facility, if the food processing plant: (i) Manufactures food using ingredients that do not require temperature control for safety; (ii) Manufactures food that is not temperature controlled for safety; or (iii) Is a food warehouse that stores and distributes food that requires temperature control for safety; or (c) Low priority facility, if the food processing plant is a food warehouse that stores food or ingredients that do not require temperature control for safety. F. The Department may allow the use of equipment that meets the requirements of Regulation .10C—E of this chapter but fails to comply with Regulation .10A of this chapter if a review indicates the equipment and its use are: (1) Not harmful to public health; and (2) Consistent with industry standards and practices. G. The Department may accept plant, facilities, and grounds design and construction other than those that are provided for in Regulation .09 of this chapter based on a review that shows the alternative plant, facilities, and grounds design: (1) Provides for adequate food safety, food protection, and sanitation; and (2) Is equivalent to regulatory and industry standards. #### Regulation .15 On-Farm Home Processing. *COMAR 10.15.04.15* A. The Department may issue a food processing plant license to an individual who owns, leases, rents, or resides on a farm to process food in a home or domestic kitchen, located on the individual’s farm, as set forth in this regulation. B. While operating with a license issued in accordance with §A of this regulation, the person-in-charge shall: (1) Comply with this chapter except for: (a) Regulation .09C(2)(a), D, and E; and (b) Regulation .12D, F(3), and G(1); (2) Limit processed food production to: (a) An amount of food that can safely be produced in the domestic kitchen as evidenced by: (i) Sanitation; (ii) Process; and (iii) Cross-contamination control; and (b) $50,000 or less of sales other than foods processed under §§E and F of this regulation; (3) Process commercially only during times when the kitchen is not being used for domestic purposes; (4) Clean and sanitize all food-contact surfaces, equipment, and utensils, immediately before and after processing commercially; (5) While processing commercially: (a) Use only building areas, equipment, and utensils that the Department has reviewed or inspected and approved; and (b) Remove all animals and individuals not involved in food processing from the kitchen; and (6) Store ingredients for commercial manufacturing and finished manufactured food in a separate area from foods used domestically. C. Except as provided in §§E and F of this regulation, an individual licensed in accordance with this regulation may manufacture and process only: (1) Baked cakes, muffins, or cookies with a water activity of .85 or less; (2) Fruit pies with an equilibrated pH of 4.6 or less; (3) Canned acid foods with an equilibrated pH of 4.6 or less; (4) Herbs in vinegar with an equilibrated pH of 4.6 or less; (5) Honey and herb mixtures; (6) Dried fruits and vegetables; and (7) Acidified foods. D. An individual licensed in accordance with this regulation may not process: (1) Low-acid canned foods; (2) Cured or fermented foods; (3) Except as provided in §E(6) of this regulation, seafood; (4) Apple cider or other juices; (5) Grade A milk product or manufactured grade milk product as defined in Health-General Article, §21-401, Annotated Code of Maryland; and (6) A frozen dessert as defined in Health-General Article, §21-801(b), Annotated Code of Maryland. E. An individual licensed in accordance with this regulation may: (1) Weigh, label, and sell raw meat and poultry that is under the jurisdiction of the United States Department of Agriculture; (2) Distribute raw meat or poultry that is under the jurisdiction of the United States Department of Agriculture; (3) Weigh, package, label, and sell raw meat and poultry that is inspected by the Maryland Department of Agriculture in accordance with Regulation .20 of this chapter; (4) Distribute raw meat or poultry that is inspected by the Maryland Department of Agriculture in accordance with Regulation .20 of this chapter; (5) Process only animals that were: (a) Commercially raised, fed, or managed on the farm; and (b) Slaughtered and processed in accordance with Regulation .17 of this chapter; (6) While operating a fish farm, clean, weigh, package, label, and sell, or distribute, raw finfish from the farm that are not associated with histamine intoxication; and (7) Use shared equipment and utensils for both domestic and commercial uses provided that the equipment and utensils are: (a) Designed and constructed as set forth in Regulation .10 of this chapter; and (b) Cleaned and sanitized as set forth in Regulation .11 of this chapter. F. An individual licensed in accordance with this regulation may weigh, label, store, and distribute cheese that: (1) Is made on a licensed out-of-State dairy facility using only the raw milk produced by the herd on the dairy farm licensed by the Department; and (2) Meets the definition and standards of a hard cheese, as set forth in section 21 CFR §133.150. G. When a farm ceases to be a farm, a food processing license issued in accordance with this regulation becomes void. H. In the absence of a license issued in accordance with COMAR 10.15.03, a license issued in accordance with this regulation shall provide for the sale on the farm of food processed on the farm by the licensee. I. Except as provided in Regulation .17 of this chapter, a person may not process food for human consumption on a farm without the license required in Regulation .18A of this chapter. #### Regulation .16 Producer Mobile Farmer’s Market Unit. *COMAR 10.15.04.16* A. The Department may issue a food processing plant license to operate a producer mobile farmer’s market unit to transport for sale at a farmer’s market, public festival, or public event, TCS food products: (1) Produced or stored on the farm by the licensee under an on-farm home processing plant license; (2) Produced or stored on the farm by the licensee, as authorized by the Department in regulation; or (3) That have been inspected, licensed, or certified for food safety by the Maryland Department of Agriculture. B. The person-in-charge shall ensure that the producer mobile farmer’s market unit: (1) Complies with Regulations .07G, N, and O and .10D, H, and K of this chapter; and (2) Displays the license on the unit during operation. C. A local health department shall: (1) Enforce §B of this regulation; (2) Levy fines as established in local law, ordinance, or regulation; (3) Notify the Department of any violations occurring in the county; and (4) Accept a valid producer mobile farmer’s market unit license to sell products authorized for sale under the license without requiring separate licenses or permits. #### Regulation .17 Animal Slaughtering, Meat Processing, and Poultry Processing. *COMAR 10.15.04.17* A person that slaughters animals and processes meat shall ensure that: A. Animal slaughtering, meat processing, poultry processing, meat sales, and poultry sales are regulated and inspected in conformance with the applicable: (1) Federal laws; (2) Federal regulations; (3) State laws; (4) State regulations; (5) Local laws; and (6) Local regulations; B. Cattle, sheep, swine, goats, horses, mules, and other equine are slaughtered and processed in accordance with: (1) The Federal Meat Inspection Act, 21 U.S.C. §§601—695; and (2) Applicable federal, State, and local laws and regulations; C. Poultry are slaughtered and processed in accordance with: (1) The Poultry Products Inspection Act, 21 U.S.C. §§451—471; and (2) Applicable federal, State, and local regulations; D. When slaughtered and processed for food for the public, domesticated animals, including poultry and rabbits that are not required by federal law or regulation to be inspected by the United States Department of Agriculture, are: (1) Inspected by the: (a) United States Department of Agriculture under a voluntary inspection program; or (b) Maryland Department of Agriculture under a voluntary inspection program; and (2) Processed into human food while being regulated by: (a) The United States Department of Agriculture under a voluntary inspection program; or (b) A meat inspection program or poultry inspection program administered by the Maryland Department of Agriculture; and E. When processing deer meat for charitable donation: (1) Any processed deer is legally harvested; (2) Gutting and skinning of the deer and butchering operations shall be separated by: (a) Time; or (b) Distance; (3) Processing other animal species is separated by: (a) Time; or (b) Distance; (4) Hanging meat carcasses are stored at an internal temperature of 41°F or less; (5) Deer is processed for distribution only as fresh or frozen: (a) Raw whole cuts; or (b) Raw, ground 100 percent venison; (6) Organ meat is not donated; and (7) A label containing cooking instructions is included. #### Regulation .18 Licensing. *COMAR 10.15.04.18* A. In order to operate a food processing plant, a person shall obtain a food processing license pursuant to the provisions of: (1) Health-General Article, §§21-211 and 21-305, Annotated Code of Maryland; and (2) This chapter. B. The Department shall specify on the food processing license what foods or food types the licensee is authorized to process. C. The Department shall deny an application for a license if the applicant: (1) Does not meet the requirements of: (a) Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or (b) A regulation promulgated under Health-General Article, §21-211, or Title 21, Subtitle 3, Annotated Code of Maryland; or (2) Fraudulently or deceptively attempts to obtain a license. D. The Department may suspend or revoke a license if the licensee: (1) Violates or fails to meet the requirements of §C of this regulation; or (2) Fraudulently or deceptively obtains a license. E. The Department may deny an application for a food processing plant license and may suspend or revoke a license pursuant to the provisions of: (1) Health-General Article, §§21-211, 21-311, and 21-314—21-317, Annotated Code of Maryland; and (2) State Government Article, §10-226, Annotated Code of Maryland. F. The person-in-charge shall ensure that: (1) Food is not processed without the license required by Health-General Article, §21-305, Annotated Code of Maryland; (2) The required food processing license is conspicuously posted in the plant; and (3) The processing operations in the plant are limited to the food type or types specified on the license pursuant to §B of this regulation. G. Except as provided in §H of this regulation, a license may not be transferred from one person to another person or from one food processing plant to another. H. On the death of a licensee, the approving authority may transfer a food processing plant license if: (1) An application is filed in accordance with Health-General Article, §21-306, Annotated Code of Maryland; and (2) Written evidence establishes that the applicant’s relationship with the deceased was as a: (a) Spouse of the deceased licensee; (b) Blood relative to the first degree of consanguinity; or (c) Current officer or surviving partner in the business operating the food processing plant. #### Regulation .19 Vacant. *COMAR 10.15.04.19* #### Regulation .20 Inspections. *COMAR 10.15.04.20* A. The person-in-charge shall permit a representative of the Department to: (1) Enter a food processing plant at a reasonable time for the purpose of making inspections to determine compliance with this chapter; and (2) Examine the records of the facility that pertain to information regarding food and supplies: (a) Purchased; (b) Received; (c) Manufactured; (d) Sold; or (e) Distributed. B. The person-in-charge shall inform the Department of a food ingredient or a recipe that the person-in-charge considers a trade secret, except as provided in §C of this regulation. C. The person-in-charge shall provide information to the Department regarding a food ingredient or recipe that the person-in-charge considers a trade secret if: (1) An immediate and substantial danger to public health exists involving the food ingredient or recipe; or (2) The Department determines that the information about the food ingredient or recipe is necessary to conduct a foodborne disease investigation. D. The person-in-charge shall ensure that: (1) Compliance with this chapter is continuous; (2) Violations are corrected within the time for correction given by the Department; (3) When a violation of a critical item exists: (a) The violation is corrected immediately; (b) Food processing affected by the critical item violation ceases; or (c) The food processing plant is closed immediately; and (4) For a food processing plant that operates seasonally or intermittently, inspection and regulation by the Department is facilitated by notifying the Department of: (a) The dates and times of operation; or (b) Information necessary to ensure that the Department has the opportunity to inspect the food processing plant during plant operation. E. The Department shall maintain the confidentiality of trade secret information in accordance with General Provisions Article, §4-335, and Health-General Article, §21-259, Annotated Code of Maryland. F. When an inspection of a food processing plant is made, the Department shall: (1) Complete an inspection report that identifies the: (a) Conditions found that violate the provisions of this chapter; and (b) Critical item violations, noted separately from all other violations; (2) Provide a copy of the inspection report to the person-in-charge of the plant; and (3) Make the completed inspection report form available for public disclosure in accordance with General Provisions Article, §§4-101—4-104, 4-201—4-206, 4-301—4-362, and 4-501—4-503, Annotated Code of Maryland. G. The Department shall ensure that a food processing plant is inspected: (1) As determined by the Department or by statute for the enforcement of this chapter; (2) At a minimum of the frequency required by COMAR 10.15.07.01 for any shellfish: (a) Shucker-packer; or (b) Repacker; (3) At a minimum of two times per year for any shellfish: (a) Shipper; or (b) Reshipper; (4) At another frequency for shellfish required by COMAR 10.15.07.01; or (5) When a: (a) High priority plant, at a minimum of once per 12 months; (b) Moderate priority plant, at a minimum of once per 24 months; and (c) Low priority plant, at a minimum of once every 36 months. #### Regulation .21 Enforcement. *COMAR 10.15.04.21* A. The approving authority shall ensure that when a food processing plant is found in violation of any provision of this chapter, the licensee is notified: (1) Of the specific: (a) Findings; and (b) Date by which the licensee shall correct the violations or deficiencies; and (2) That, if the licensee fails to correct the violation by the date specified, the approving authority may suspend or revoke the license. B. When a person is violating any provision of this chapter, the approving authority may serve the person with a written order pursuant to Health-General Article, §21-261 or 21-318, Annotated Code of Maryland, directing the person to abate the violation within a specified time period. C. The approving authority shall ensure that an opportunity for a hearing is provided to a person served with an order, pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. D. In order to preserve a right to a hearing under any provision of this regulation, a person shall: (1) Make a request for a hearing in writing; and (2) Submit the request to the approving authority that issued the order or inspection report: (a) Within 10 days of receipt of the order; (b) Sooner if specified in the order; or (c) Within 24 hours if the violation requires immediate correction or correction within 24 hours. E. The approving authority shall suspend or revoke the license of a food processing plant if the licensee fails or neglects to: (1) Correct a: (a) Violation within the specified time period; or (b) Violation of a critical item immediately; or (2) Comply with an approved written schedule of compliance. F. The approving authority shall ensure that: (1) An action to suspend or revoke a license, complies with the provisions of: (a) State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland; and (b) Health-General Article, §21-315, Annotated Code of Maryland; and (2) The person against whom the action is contemplated is given an opportunity for a hearing in accordance with Health-General Article, §21-316, Annotated Code of Maryland. G. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to State Government Article, §10- 226(c)(2), Annotated Code of Maryland, the: (1) Approving authority shall: (a) Summarily suspend the license at the food processing plant; (b) Order the food processing plant to cease operation immediately; and (c) Promptly provide the licensee with: (i) A written notice of suspension of the license; (ii) The reasons for the suspension; and (iii) Instructions on requesting an administrative hearing if desired; and (2) Person-in-charge shall immediately cease the operation of the food processing plant. H. The person-in-charge shall ensure that a food processing plant that has been required under the provisions of this regulation to cease operations does not resume operations until a reinspection by the approving authority shows that the condition or conditions responsible for the requirement to cease operations no longer exist. I. The approving authority shall confirm that appropriate steps are taken to ensure that the licensee ceases operation of the food processing plant on suspension or revocation of the license, including: (1) Taking and keeping physical possession of the license until the license is reinstated; and (2) Posting a sign on the facility door stating that the license has been suspended or revoked by the approving authority. J. A person whose food processing plant license has been suspended or revoked may apply for reinspection and reinstatement of the license by submitting to the approving authority a written request that details the actions taken by the person to correct each violation of a food statute or regulation that caused the suspension or revocation. #### Regulation .22 Foodborne Disease Investigation and Control. *COMAR 10.15.04.22* The approving authority shall ensure that: A. When there is reasonable cause to suspect foodborne disease transmission or an outbreak from a food processed or distributed by a food processing plant, an inspection of the plant is conducted to: (1) Identify: (a) Potential points of food contamination in the facility; (b) Whether employee illness may have contributed; and (c) Whether a contaminated ingredient was used to process a food; and (2) Determine if affected food has been distributed into commerce; and B. The appropriate follow-up action is taken, which may include immediate: (1) Closing of the food processing plant, or a portion of the plant that is used to process the implicated product; or (2) Exclusion of a suspect employee from all food handling positions within the plant until medical and epidemiological evidence shows that the likelihood of further foodborne disease transmission is low in accordance with COMAR 10.06.01. #### Regulation .23 Traceability, Sampling, and Detention. *COMAR 10.15.04.23* A. The person-in-charge shall ensure that: (1) Records are maintained that allow for traceability of food or food ingredients received by the food processing plant that include the: (a) Date received; and (b) Previous source’s: (i) Name; (ii) Address; and (iii) Contact information; (2) Records are maintained that allow for traceability of food and food ingredients that identify the initial distribution of the food that include: (a) The date the food was released; (b) A lot code number or other identifier, if available; (c) The type of food released, including brand name and specific variety; and (d) For the transporter of the food and the intended immediate recipient, the: (i) Name; (ii) Address; and (iii) Contact information; (3) All records maintained that allow for traceability are made available to the Department for review and copying upon request; and (4) The collection of food and environmental samples by the Department is allowed in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland. B. The Department shall: (1) Collect food and environmental samples as often as necessary for enforcement of this chapter; (2) Sample food in accordance with Health-General Article, §§21-249 and 21-251, Annotated Code of Maryland; and (3) Take action on a food where indicated in accordance with Health-General Article, §§21-211, 21-253, and 21-254, Annotated Code of Maryland, by: (a) Issuing a detention order; (b) Seeking voluntary destruction; or (c) Filing a petition for an order of forfeiture for destruction. ### Chapter 05 — Manufacture and Sale of Frozen Dairy Foods and Ices Manufactured for Sale in Maryland **Authority:** Health-General Article, §21-804, Annotated Code of Maryland **Administrative History:** Effective date: November 15, 1973 **Administrative History:** Regulations .25A, .26U, and .27A amended effective August 25, 1978 (5:17 Md. R. 1330) **Administrative History:** Chapter revised effective June 12, 1981 (8:12 Md. R. 1062) **Administrative History:** Regulations .02C, .14, .21B, .25G, H, I, .29A, and .30 amended effective January 12, 1987 (14:1 Md. R. 31) **Administrative History:** Regulations .10-1, .20-1, .20-2, and .20-3 adopted effective January 12, 1987 (14:1 Md. R. 31) **Administrative History:** Regulation .21B amended effective January 2, 1994 (20:26 Md. R. 2027) **Administrative History:** Regulation .22 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236) **Administrative History:** Regulation .25A amended effective January 2, 1994 (20:26 Md. R. 2027) **Administrative History:** Regulation .35 repealed and new regulation .35 adopted effective January 12, 1987 (14:1 Md. R. 31) **Administrative History:** Regulation .35 amended as an emergency provision effective June 27, 2012 (39:15 Md. R. 962); amended permanently effective October 1, 2012 (39:19 Md. R. 1236) **Administrative History:** Chapter revised effective February 27, 2017 (44:4 Md. R. 254) #### Regulation .01 Incorporation by Reference. *COMAR 10.15.05.01* The Grade “A” Pasteurized Milk Ordinance, 2015 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Item 10p., Item 11p., Appendix H, Appendix I, and Appendix N only, is incorporated by reference. #### Regulation .01-1 Ice Cream and Frozen Custard. *COMAR 10.15.05.01-1* Ice cream and frozen custard are the foods prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard. #### Regulation .02 Ice Milk. *COMAR 10.15.05.02* A. Ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk. B. Ice milk shall be offered for sale, sold, or served only in properly labeled factory-filled containers, if the ice milk or any of its ingredients contain added color or any ingredients added for the purpose of imparting a characterizing flavor, except that ice milk may be served and sold at retail from a dispensing freezer. C. When ice milk is sold at retail, direct from a frozen dessert dispensing freezer, a sign shall be prominently and conspicuously displayed, where it can be clearly read by customers under normal conditions of purchase, stating “Ice Milk Sold Here”. The letters on the sign shall be bold-face capitals at least 3 inches high and in contrasting color to the background. When ice milk is sold at retail, only in properly labeled factory-filled containers, this sign is not required. #### Regulation .03 Mellorine. *COMAR 10.15.05.03* A. Mellorine is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.130, Mellorine. B. Mellorine shall be sold, held, offered for sale only in factory-filled containers. #### Regulation .04 Sherbet. *COMAR 10.15.05.04* Sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140, Sherbet. #### Regulation .05 Water Ices. *COMAR 10.15.05.05* Water ices are the foods each of which is prepared from the ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21, Food and Drugs, Part 135.160, Water Ices. #### Regulation .06 Goat Milk Ice Cream. *COMAR 10.15.05.06* A. Description. Goat milk ice cream is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110, Ice Cream and Frozen Custard, except that all milkfat and nonfat milk solids shall be derived from goat milk. B. Nomenclature. The name of the food is “goat milk ice cream”. C. Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words “ice cream”. #### Regulation .07 Goat Milk Ice Milk. *COMAR 10.15.05.07* A. Description. Goat milk ice milk is the food prepared from the same ingredients and in the same manner, including the requirements for label statements of optional ingredients, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120, Ice Milk, except that all milkfat and nonfat milk solids shall be derived from goat milk. B. Nomenclature. The name of the food is “goat milk ice milk”. C. Label Declaration. On the label, in the name of the food, the letters in the words, “goat milk” shall be the same size, type, and color, and on the same contrasting background as the letters in the words, “ice milk”. #### Regulation .08 Frozen Yogurt. *COMAR 10.15.05.08* A. Description. Frozen yogurt is the food prepared by freezing while stirring a pasteurized mix consisting of the same ingredients permitted for ice cream in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.110. These ingredients are cultured after pasteurization by one or more strains of Lactobacillus bulgarius and streptococcus thermophilus, provided, however, fruits, nuts or other flavoring materials may be added before or after the mix is pasteurized and cultured. Bacteria and coliform requirements for frozen yogurt shall apply to the mix before culturing. Coliform requirements for frozen yogurt shall apply to the mix after culturing. Frozen yogurt, exclusive of any flavoring, shall contain not less than 3.25 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than the result of bacterial activity, shall be applied to the product after culturing. No heat or bacteriostatic treatment (other than refrigeration), which results in the total destruction of the microorganisms, may be applied to the product after culturing. The finished yogurt shall weigh not less than 5 pounds per gallon. B. Nomenclature. The name of the food is “frozen yogurt”. C. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .09 Lowfat Frozen Yogurt. *COMAR 10.15.05.09* A. Description. Lowfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Lowfat frozen yogurt, exclusive of any flavorings, shall contain not less than .5 percent or more than 2.0 percent milkfat and not less than 8.25 percent milk solids not fat and has a titratable acidity of not less than .5 percent expressed as lactic acid. B. Nomenclature. The name of the food is “lowfat frozen yogurt”. C. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .10 Nonfat Frozen Yogurt. *COMAR 10.15.05.10* A. Description. Nonfat frozen yogurt is the food prepared from the same ingredients and in the same manner prescribed in Regulation .08 of this chapter. Nonfat frozen yogurt, exclusive of any flavorings, shall contain less than .5 percent milkfat. B. Nomenclature. The name of the food is “nonfat frozen yogurt”. C. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .11 Quiescently Frozen Confection. *COMAR 10.15.05.11* A. Description. Quiescently frozen confection means the frozen product made from sweetening agents, harmless natural or artificial flavoring, and water, and it may contain milk solids, harmless coloring, organic acids, and any safe and suitable functional ingredient approved by the Secretary. The finished product shall contain not less than 17 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer. B. Nomenclature. The name of the food is “quiescently frozen confection”. C. Labeling. In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .12 Quiescently Frozen Dairy Confection. *COMAR 10.15.05.12* A. Description. Quiescently frozen dairy confection means the frozen product made from milk products, sweetening agents, harmless natural or artificial flavoring, and water, and it may contain harmless coloring, and any safe and suitable functional ingredient approved by the Secretary. The finished product contains not less than 33 percent by weight of total food solids. In the manufacture of this product, freezing has not been accompanied by stirring or agitation (generally known as quiescent freezing). In the production of this quiescently frozen dairy confection, no processing or mixing before quiescent freezing may be used that develops in the finished confection mix any physical expansion in excess of 10 percent. This confection shall be manufactured in the form of servings, individually packaged, bagged, or otherwise wrapped, properly labeled, and purveyed to the consumer in its original factory-filled package. The individually wrapped confection need not be labeled if it is contained in a multiple package which is properly labeled and purveyed unopened to the consumer. B. Nomenclature. The name of the food is “quiescently frozen dairy confection”. C. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .13 Frozen Dietary Dairy Dessert. *COMAR 10.15.05.13* A. Description. Frozen dietary dairy dessert means a frozen dessert prepared for persons who wish to restrict their intake of ordinary sweetening ingredients. It is produced by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The minimum fat content shall be 3 percent, it shall contain no sugars other than those naturally present in the milk solids or flavoring agents which have been added to it, and it may contain edible carbohydrates other than sugars. The edible carbohydrates must be approved by the Department. The product may not be sold in any manner other than in sealed or unbroken packages or containers. B. Nomenclature. The name of the food is “frozen dietary dairy dessert”. C. Labeling. (1) Immediately preceding or following the name of the product, there shall be a statement as follows: “Contains ___% milkfat”. The blank is to be filled in with the percentage of milkfat in the product. The label of frozen dietary dairy dessert shall contain the statement: “Diabetics: This product may be useful in your diet on the advice of a physician. This food is not a reduced calorie food.” (2) In addition to all other required information, the label shall comply with the applicable regulations promulgated under the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .14 Dietary Frozen Dessert or Lowfat Frozen Dairy Desserts. *COMAR 10.15.05.14* A. Description. (1) Dietary frozen dessert or lowfat frozen dairy dessert is the food prepared by freezing while stirring a pasteurized mix consisting of the ingredients permitted for ice cream in Regulation .01-1 of this chapter. The finished product contains less than 2 percent by weight of ether extractable fat: its content of total milk solids is not less than 7 percent by weight. The product weighs no less than 4.5 pounds per gallon and the quantity of food solids per gallon is not less than 1.1 pounds or more than 1.9 pounds, exclusive of any microcrystalline cellulose used as an ingredient. (2) One or more vitamins or minerals, or both, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.9 may be added to the product. If vitamins or minerals, or both, are added, each 4-fluid-ounce serving of finished product shall provide not less than 8 percent or more than 20 percent of the U. S. Recommended Daily Allowance of these vitamins or minerals, or both. (3) Dietary frozen dessert or lowfat frozen dairy dessert may be sold in properly labeled factory-filled containers, except it may be sold directly from a dispensing freezer at the time of a direct request from a customer. When sold directly from a dispensing freezer, each container shall be labeled with the name of the product and with the name of the product and with nutritional and ingredient information as prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. B. Nomenclature. The name of the food is “dietary frozen dessert” or “lowfat frozen dairy dessert”. C. Labeling. (1) If vitamins or minerals, or both, are added, the name of the food on the principal display panel and each alternate principal display panel shall be immediately preceded or followed by the word “fortified” in the same style and at least one-half the size of the type used for the name “dietary frozen dessert” or “lowfat frozen dairy dessert” and on the same contrasting background. (2) In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .15 Non-fruit Sherbet. *COMAR 10.15.05.15* A. Description. Non-fruit sherbet is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.140 Sherbet, except that the food may not contain any fruit or fruit juice. B. Nomenclature. The name of the food is “Non-fruit ___ Sherbet”. The blank is to be filled in by the characterizing flavor used. C. Labeling. (1) The label shall contain the following statement: “Imitation ___ Sherbet”, the blank to be filled in by the characterizing flavor used. The letters in the word “imitation” shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, sherbet. (2) The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice” in letters at least half the size of the words used in the statement. (3) When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation. #### Regulation .16 Non-fruit Water Ice. *COMAR 10.15.05.16* A. Description. Non-fruit water ice is a food prepared from the same ingredients and in the same manner, including the requirements for labeling, prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.160 Water Ices, except that the food may not contain any fruit or fruit juice. The finished non-fruit water ice weighs not less than 6 pounds per gallon. B. Nomenclature. The name of the food is “Non-fruit ___ Water Ice”. The blank is to be filled in by the characterizing flavor used. C. Labeling. (1) The label shall contain the following statement: “Imitation ___ Ice”. The blank is to be filled in by the characterizing flavor used. The letters in the word imitation shall be the same size, type, and color and on the same contrasting background as the name of the characterizing flavor and the word, ice. (2) The statement in §C(1), of this regulation, shall be followed immediately by the words, “contains no fruit or fruit juice”, in letters at least half the size of the words used in the statement. (3) When a sign is used at the point of purchase to advertise the product, it shall contain the same information prescribed in §C(1) and (2), of this regulation. #### Regulation .17 Manufactured Desserts Mix. *COMAR 10.15.05.17* A. Description. “Manufactured desserts mix”, whipped cream confection, bisque tortoni, means a frozen dessert made with milk products, sweetening agents, flavoring agents, with or without harmless coloring or any other safe and suitable ingredients approved by the Secretary. It contains not less than 18 percent by weight of milkfat, and not more than 12 percent of milk solids not fat, and may be packaged with harmless gas causing it to fluff upon ejection from the package or container. B. Labeling. In addition to all other required information, the label shall comply with the provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .18 Freezer-Made Shake Freezer-Made Milk Shake. *COMAR 10.15.05.18* A. “Freezer-made milk shake” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mix consisting of the ingredients prescribed in the Code of Federal Regulations, Title 21 Food and Drugs, Part 135.120 Ice Milk, except that: (1) It shall contain not less than 3-1/4 percent and not more than 6 percent milkfat. (2) Its contents of milk solids not fat shall be not less than 10 percent. Freezer-made milk shake may only be sold or served from a dispensing freezer and may not be sold hard-frozen. B. Other freezer-made shakes including jumbo shake, thick shake, T.V. shake, or any coined or trade name containing the word, “shake”, shall meet the requirements of §A, of this regulation, except that the minimum percent of milk fat may be less than 3-1/4 percent. C. “Shakes” not meeting the requirements for “milk shakes” may not be advertised, sold, or served as milk shakes. D. When any freezer-made milk shake or other freezer-made shake purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .19 Parevine. *COMAR 10.15.05.19* A. Description. (1) Parevine is the food which is prepared by freezing while stirring, a pasteurized mix composed of one or more edible vegetable oils or fats, protein and carbohydrate food ingredients from other than milk or meat sources, nutritive sweeteners other than lactose, characterizing ingredients except any containing meat or milk, and any other safe and suitable ingredient which is not milk or meat or a product or derivative of milk or meat. This product may not contain any milk, milk product, meat, or meat products or any of their derivatives of any kind. (2) Its fat content shall be not less than 10 percent, except that when bulky optional characterizing ingredients are used, the fat content may be reduced, as a result of the addition of these ingredients, but may not be less than 8 percent. (3) Its content of food solids shall be not less than 1.3 pounds per gallon of finished product. (4) Parevine shall be sold, held, offered for sale by any manufacturer, wholesaler, retailer, or any other seller only in factory-filled containers. Parevine may be served for consumption on the premises provided that the individual service is taken from a properly labeled factory-filled container. When parevine is served for consumption on the premises, a sign shall be conspicuously displayed on the sale premises or vehicle where it can be clearly read by customers under normal conditions of purchase, stating “PAREVINE SOLD HERE”. Letters on the sign shall be bold face capitals at least 3 inches high and in contrasting color to the background. The sign need not be displayed if each customer is provided with a menu which there is stated “PAREVINE SERVED HERE” in bold face capitals as large as those in listing most food items. B. Nomenclature. The name of the food is “parevine”. C. Labeling. In addition to all other required information, the label shall comply with the applicable provisions prescribed in the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .19-1 Lowfat Parevine. *COMAR 10.15.05.19-1* A. Description. “Lowfat parevine” means food which meets all of the requirements of Regulation .19, of this chapter, relating to parevine except its fat content shall be not more than 6.0 percent. The sign required by Regulation .19A(4), of this chapter, shall read “LOWFAT PAREVINE SOLD HERE”. B. Nomenclature. The name of the food is “lowfat parevine”. C. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutrition information as required by Title 21, Part 101.9. #### Regulation .20 Lo-Mel. *COMAR 10.15.05.20* A. Description. (1) “Lo-mel” means a pure, clean, wholesome semi-viscous drink prepared by stirring while freezing in a dispensing freezer a pasteurized mixture of edible fats or oils other than milkfat, milk solids not fat, water, optional sweetening ingredients as approved by the Secretary, with or without egg or egg products, with or without harmless flavoring, with or without harmless coloring, and with or without stabilizer or emulsifier as approved by the Secretary. It shall contain not more than 6 percent edible fats or oils. It shall contain not less than 10 percent milk solids not fat. It may contain any other safe and suitable ingredients approved by the Secretary. It shall contain not more than 1/2 percent by weight of stabilizer and not more than one-fifth of one percent of emulsifier. (2) Lo-mel may only be served or sold directly from a dispensing freezer and may not be sold hard frozen. (3) When Lo-mel is sold from a dispensing freezer a sign shall be displayed which shall read “Lo-mel Served Here”, in letters at least 3 inches high and shall include a list of all ingredients in a manner prescribed by the Secretary, provided, however, that the name of the edible fats or oils other than milk fat used must be specified. The letters of the sign are to be of sufficient size to be read by consumers under normal conditions of purchase. The list of ingredients need not be included on the sign if the list of ingredients is printed on the side of the container in which the product is served to the customer. B. Nomenclature. The name of the food is “lo-mel”. C. Labeling. When any lo-mel purports to be or is represented for any special dietary use by man, it shall be sold only in a container labeled in accordance with all applicable provisions of the Code of Federal Regulations, Title 21 Food and Drugs. #### Regulation .20-1 Lactose Reduced Ice Cream. *COMAR 10.15.05.20-1* A. Description. “Lactose reduced ice cream” means the product resulting from the treatment of ice cream, as defined in Regulation .01-1 of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice cream. B. Nomenclature. The name of the food is “lactose reduced ice cream”. C. Labeling. (1) The package label shall include in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required Part 101.4 and contain nutritional information as required by Title 21, Part 101.9. (2) Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style, and size and in the same color and contrasting background as the words “Ice Cream”. #### Regulation .20-2 Lactose Reduced Ice Milk. *COMAR 10.15.05.20-2* A. Description. “Lactose reduced ice milk” means the product resulting from the treatment of ice milk, as defined in Regulation .02, of this chapter, by the addition of a safe and suitable enzyme, or enzymes, so that the lactose remaining is 30 percent or less than lactose in ice milk. B. Nomenclature. The name of the food is “lactose reduced ice milk”. C. Labeling. (1) The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4 and contain nutritional information as required by Title 21, Part 101.9. (2) Whenever the name of the food appears on the container, the words “Lactose Reduced” shall be in the same type, style and size and in the same color and contrasting background as the words “Ice Milk”. #### Regulation .20-3 Frozen Pudding. *COMAR 10.15.05.20-3* A. Description. “Frozen pudding” means the product made from a pasteurized mix, intended to be eaten in the frozen state. The mix may be composed of milk and milk products, modified or unmodified food starch, sweetening agents, harmless natural or artificial flavoring, or both, harmless natural or artificial color, or both, or any other safe or suitable functional ingredient. The finished product shall contain less than 25 percent total food solids. The weight of the finished product shall not be less than 4.5 pounds per gallon. If not frozen promptly after pasteurization, the finished product shall be cooled to 45°F or lower and maintained under conditions to assure suitability for consumption. B. Nomenclature. The name of the food is “frozen pudding”. C. Labeling. The package label shall include, in addition to all other required information, a complete list of all ingredients in accordance with the provisions of the Code of Federal Regulations, Title 21 Food and Drugs, Part 101.4. #### Regulation .21 Definitions. *COMAR 10.15.05.21* A. In Regulations .21 — .34 of this chapter the following terms have the meanings indicated. B. Terms Defined. (1) “Adulterated”. Frozen desserts or frozen desserts mix shall be deemed to be adulterated if: (a) It bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health; (b) It bears or contains any added poisonous or deleterious substances for which a safe tolerance has not been established by State or federal regulations, or in excess of the tolerance if one has been established; (c) It consists, in whole or in part, of any substance unfit for human consumption; (d) It has been produced, processed, prepared, packed, dispensed, or held under insanitary conditions; (e) Its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (f) Any substance has been added, mixed, or packed within the mix to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. (2) “CFR” means the Code of Federal Regulations of the United States Government. (3) “C-I-P” means a procedure by which equipment, pipelines and other facilities are cleaned-in-place in accordance with 3-A Accepted Practices for Permanently Installed Sanitary Product-Pipelines and Cleaning Systems. (4) “Dispensing freezer” means that type of equipment that freezes reconstituted powdered frozen dessert ingredients or frozen desserts mix into a semi-soft condition for serving to a customer. (5) “Food service facility” means restaurants, coffee shops, cafeterias, short order cafes, luncheonettes, taverns, sandwich stands, sofa fountains, retail markets, and food operations in industries, institutions, hospitals, clubs, schools, camps, churches, catering kitchens, commissaries, or similar places in which food or drink is prepared for sale or for service on the premises or elsewhere, or any other operation where food is served or provided for the public with or without charge. (6) “Frozen desserts” means any of the products enumerated in the law, Health-General Article, Title 21, Subtitle 8, and as provided in Regulations .01-1 — .20-3 of this chapter. (7) “Frozen desserts distributor” means any person who offers for sale or sells prepackaged frozen desserts. (8) “Frozen desserts mix” or “mix” means any frozen dessert in a liquid form, prepared by a frozen desserts plant and intended for freezing before consumption. (9) “Frozen desserts plant” means any place or premise where frozen desserts or frozen dessert mixes are manufactured, pasteurized, frozen, and packaged. (10) “Milk products” include milk, cream, and all other products listed under optional dairy ingredients as provided in Regulation .01-1 of this chapter. (11) “Misbranded”. Frozen desserts and frozen desserts mix are misbranded when: (a) Their containers bear or accompany any false or misleading written, printed, or graphic matter; (b) Frozen desserts do not conform to their definitions as contained in these regulations; and (c) Products are not labeled in accordance with Regulation .24 of this chapter. (12) “National Sanitation Foundation” means the National Sanitation Foundation, NSF Building, P.O. Box 1468, Ann Arbor, Michigan 48106. (13) “Pasteurization”. (a) The terms “pasteurization”, “pasteurized”, and similar terms mean the process of heating, in approved and properly operated equipment, every particle of mix containing milk and milk products to one of the following minimum temperatures and holding at this temperature continuously for the specified time as indicated below: (i) 155°F and holding at that temperature for at least 30 minutes; (ii) 175°F and holding at that temperature for at least 25 seconds; (iii) 180°F and holding at that temperature for at least 15 seconds; (iv) 194°F and holding at that temperature for at least 0.5 second. (b) Nothing contained in this section shall be construed as barring any other method or process, as may be demonstrated to be equally efficient and which is approved by the Secretary. (14) “Person” means any individual, partnership, firm, corporation, or association. (15) “Powdered frozen dessert ingredients” means any dry mixture of pasteurized dry milk products, including whey, reduced mineral whey, whey protein concentrate, reduced lactose whey, or optional casseinates, which is intended for reconstitution, freezing, and retail sale by a food service facility. (16) “Retail frozen desserts manufacturer” means a person who manufactures frozen desserts from commercially supplied pasteurized mix derived from raw milk supplies having acceptable United States Public Health Service (U.S.P.H.S.) ratings, for retail sale directly to the consumer on the premises where manufactured. (17) “Sanitization” means the application of any effective method or substance to a clean surface for the destruction of pathogens, and of other organisms as far as is practicable. This treatment may not adversely affect the equipment, frozen desserts, or the health of consumers, and shall be acceptable to the Secretary. (18) “Secretary” means the Secretary of Health or his designee. (19) "3-A Standards" means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the International Association of Milk, Food and Environmental Sanitarians, the U.S. Public Health Service, and the Dairy Industry Committee, as published by the Journal of Food Protection, P.O. Box 701, Ames, Iowa 50010. (20) “Wholesale frozen desserts manufacturer” means a person who manufactures, pasteurizes, packages, or freezes any frozen desserts mix for distribution or sale other than for retail sale directly to the consumer on the premises where manufactured. #### Regulation .22 Quality of Milk Products Used in Frozen Desserts. *COMAR 10.15.05.22* All milk products used in frozen desserts shall be derived from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02. #### Regulation .23 Adulterated or Misbranded Milk Products, Frozen Desserts or Frozen Desserts Mix. *COMAR 10.15.05.23* A. A person may not manufacture, freeze, sell, offer or expose for sale, or have in his possession with the intent to sell any milk product, frozen dessert ingredients, frozen dessert mix which is adulterated or misbranded or which does not conform to the product definition or of any regulation made and promulgated under these regulations. B. Any adulterated or misbranded milk product, frozen dessert ingredients, frozen dessert, or frozen dessert mix may be detained by the Secretary and disposed of in accordance with Health-General Article, §§21-253 and 21-254, Annotated Code of Maryland. #### Regulation .24 Labeling. *COMAR 10.15.05.24* A. All labeling shall comply with the regulations promulgated under the Fair Packaging and Labeling Act and the Federal Food, Drug and Cosmetic Act, as contained in the Code of Federal Regulations, Title 21 Food and Drugs, and in addition shall contain: (1) The name of the product, and shall conform with product standards of identity as provided in Regulations .01-1 — .20 of this chapter. (2) A statement of net contents or net volume. (3) One of the following: (a) The name of the manufacturer and the address of his plant; (b) The Federal Information Processing System (FIPS) Number assigned by State agency followed by the general office address; or (c) In case of private labels, the Federal Information Processing System (FIPS) Number and the name and address of the distributor, preceded or followed by “Distributed by” or “Distributor”. (4) The “date of pasteurization” in case of frozen dessert mixes. B. When frozen desserts are dispensed from factory-filled containers, each container shall bear an identity as described above so that it can be read after the lid or cover has been removed and discarded. C. Required labeling information shall be in letters of an acceptable size, kind, and color satisfactory to the Secretary and may not bear or accompany any false or misleading written, printed, or graphic matter. #### Regulation .25 Quality Standards and Examination of Frozen Desserts Ingredients, Frozen Desserts, and Frozen Desserts Mix. *COMAR 10.15.05.25* A. All milk and milk products used as ingredients in frozen desserts and frozen desserts mix shall be produced, processed, and pasteurized to conform with the following chemical, bacteriological, and temperature standards: B. A process or manipulation, other than pasteurization processing methods, and appropriate refrigeration, may not be applied to milk and milk products for the purpose of removing or deactivating microorganisms. C. Bacterial counts, coliform determinations, cooling temperatures, phosphatase test and other laboratory and screening tests shall conform to the procedures in the latest edition of Standard Methods for the Examination of Dairy Products of the American Public Health Association and the latest edition of the Official Method of Analysis of the Association of Official Analytical Chemists. D. Examinations and tests shall include any other chemical, bacteriological, or physical determinations as the Secretary deems necessary for the detection of adulteration. E. Sterile frozen desserts mix in hermetically sealed containers shall meet all applicable requirements. Bacterial, coliform, and cooling standards do not apply to mix in hermetically sealed containers. F. When samples are obtained from bulk containers of frozen desserts or frozen desserts mix, only a cleaned and sanitized dipper shall be used to obtain a sample from a portion of the bulk amount not previously contacted by a dipper. G. Frozen dessert mix samples for determining the wholesale frozen dessert manufacturer’s compliance with bacteriological and temperature standards shall be collected while in the possession of the wholesale frozen dessert manufacturer before final delivery. H. Frozen dessert mix samples for chemical and physical analysis may be taken at any time. I. The wholesale frozen desserts manufacturer shall be held responsible only for those samples taken from unopened containers. J. Samples of hard frozen desserts, in unopened factory-filled containers, may be collected any time before sale for determining the wholesale frozen dessert manufacturer's or retail frozen dessert manufacturer's compliance with chemical and physical standards. K. Mix once drawn from a dispensing freezer shall not be re-used. #### Regulation .26 Frozen Desserts Plants — Construction Requirements. *COMAR 10.15.05.26* A. Floors — Construction. (1) The floors of all rooms shall be kept in good repair subject to the following provisions: (a) Rooms used for storing milk products or frozen desserts ingredients need not be provided with floor drains when the floors are sloped to drain to one or more exits; (b) Rooms used for the hardening and storage of frozen desserts are not required to have floor drains or sloped floors; (c) Storage rooms for storing dry ingredients, dry milk products, or packaging materials need not be provided with drains, and the floors may be constructed of tightly joined wood; and (d) Construction of establishments which freeze and sell only at retail on the premises, shall require that the portion of the room in which the freezer is installed and the room in which containers or utensils are washed have solid impervious floors of an approved washable material; (2) The floors of all rooms except as provided in §A(1)(a) — (c) of this regulation shall be: (a) Constructed of concrete or other equally impervious and easily cleaned material; (b) Smooth; (c) Properly sloped; and (d) Provided with trapped drains. B. Walls and Ceilings — Construction. Walls and ceilings of rooms in which milk products, frozen desserts ingredients, and frozen desserts are handled, processed, packaged, or stored, or in which product-contact containers, utensils, and equipment are washed, shall have a surface that is: (1) Smooth; (2) Washable; (3) Light colored; and (4) In good repair. C. Doors and Windows. (1) Effective means shall be provided to prevent the access of flies and rodents. (2) Air screens and flaps may be used where they effectively prevent the entrance of insects. (3) Openings to the outside shall have solid doors or glazed windows which shall be closed during dusty weather. (4) Outside doors shall be self-closing where practicable. D. Lighting and Ventilation. Rooms in which milk products, frozen desserts ingredients, or frozen desserts are handled, processed, stored, and packaged, or in which product-contact containers, utensils, and equipment are washed shall be well lit and well ventilated. E. Separate Rooms. (1) There shall be separate rooms for the following: (a) Pasteurizing, processing, cooling, freezing, and packaging; (b) Freezer-storage; (c) Cleaning of milk cans and containers; and (d) Boiler rooms. (2) Receiving Rooms. (a) A plant receiving milk products or mix in bulk transport tanks shall provide a receiving room for receiving, cleaning, and sanitizing transport tanks. (b) Unless all milk products and mix are received in bulk transport tanks, a receiving room separate from the rooms listed in §E(1) of this regulation, is required. (3) Rooms in which milk products, frozen dessert ingredients, or frozen desserts are handled, processed, stored, or packaged, or in which product-contact containers, utensils, and equipment are washed or stored, may not open directly into any room for domestic purposes. F. Sanitary Piping. (1) Sanitary piping, fittings, and connections which are exposed to milk products, frozen dessert ingredients, and frozen desserts mix, or from which liquids may drip, drain, or be drawn into the product, shall be constructed of material that is: (a) Smooth; (b) Impervious; (c) Corrosion-resistant; (d) Nontoxic; and (e) Easily cleanable. (2) Piping shall be kept in good repair. (3) Pasteurized milk products, frozen dessert ingredients, and frozen desserts mix shall be conducted from one piece of equipment to another only through sanitary piping as described in Items 10p. and 11p. in the Grade “A” Pasteurized Milk Ordinance. #### Regulation .26-1 Frozen Desserts Plants — Water and Sanitation Requirements. *COMAR 10.15.05.26-1* A. Toilet-Sewage Disposal Facilities. (1) A frozen desserts plant shall provide toilet facilities. (2) Toilet rooms may not open directly into any room in which milk products, frozen dessert ingredients, or frozen desserts are processed or packaged. (3) Toilet rooms shall: (a) Be completely enclosed; and (b) Have tight-fitting, self-closing doors. (4) Dressing rooms, toilet rooms, and fixtures shall be kept in a clean condition, in good repair, and shall be well ventilated and well lit. (5) Sewage and other liquid wastes shall be disposed of as approved by the Secretary. B. Water Supply. (1) Water for frozen desserts plant purposes shall be: (a) Obtained from a properly located, protected, and operated supply; (b) Easily accessible; (c) Adequate; (d) Of a safe sanitary quality; and (e) Approved by the Secretary. (2) Both hot and cold water shall be available in sufficient quantity for all plant operations and facilities. C. Handwashing Facilities. (1) Convenient handwashing facilities shall be provided, including: (a) Hot and cold or warm running water; (b) Soap; and (c) Individual sanitary towels or other approved hand-drying devices. (2) Handwashing facilities shall be kept in a clean condition and in good repair. D. Plant Cleanliness. (1) Rooms in which milk products, frozen dessert ingredients, and frozen desserts are handled, processed, stored, or packaged or in which containers, utensils, or equipment are washed or stored, shall be kept clean, neat, and free of evidence of insects and rodents. (2) Only properly applied pesticides, approved by the State and federal agencies for pesticide control, shall be used. (3) Only equipment directly related to processing and packaging operations, or to handling of containers, utensils, and equipment shall be permitted in the pasteurizing, processing, cooling, packaging, and bulk milk storage rooms. E. Construction and Repair of Containers and Equipment. (1) Multiuse containers and equipment with which milk products, frozen dessert ingredients, and frozen desserts come into contact shall be: (a) Of smooth, impervious, corrosion-resistant, nontoxic material; (b) Constructed and installed for ease of cleaning; and (c) Kept in good repair. (2) Single-service Containers. (a) Single-service containers, closures, gaskets, and other articles with which milk products, frozen dessert ingredients, or frozen desserts come into contact shall: (i) Be nontoxic; and (ii) Have been manufactured, packaged, transported, and handled in a sanitary manner. (b) Articles intended for single-service use may not be reused. (c) Equipment pertaining to materials, design, and finish shall comply with applicable 3-A Sanitary Standards. F. Cleaning and Sanitizing of Containers and Equipment. The product-contact surface of all multiuse containers, utensils, and equipment used in the transportation, processing, handling, freezing, packaging, and storage of milk products, frozen dessert ingredients and frozen desserts mix shall be effectively cleaned and sanitized before each use. G. Storage of Cleaned Multiuse Containers and Equipment. After cleaning, multiuse milk products, frozen dessert ingredients, and frozen dessert containers, utensils, and equipment shall be: (1) Transported and stored to assure complete drainage; and (2) Protected from contamination before use. H. Storage of Single-Service Containers, Utensils and Materials. Single-service parchment papers, containers, gaskets, and other single-service articles for use in contact with milk products, frozen dessert ingredients, or frozen desserts shall be: (1) Purchased and stored in sanitary wrappings or cartons; (2) Kept in a clean dry place until used; and (3) Handled in a sanitary manner. I. Protection from Contamination. (1) Frozen desserts plant operations, equipment, and facilities shall be located and conducted to prevent any contamination of: (a) Milk products; (b) Frozen dessert ingredients; (c) Frozen desserts; (d) Equipment; (e) Containers; and (f) Utensils. (2) Unless the equipment has first been properly washed and subjected to a satisfactory bactericidal treatment, pasteurized mix or frozen desserts may not be permitted to come in contact with equipment or containers with which unpasteurized mix, frozen desserts, milk, or milk products have been in contact. (3) In a frozen desserts plant, processing and handling shall be performed to preclude the contamination of the products. J. Pasteurization. (1) Frozen desserts shall be made from pasteurized mixes. (2) After formulation of the entire mix except for flavoring, ingredients shall be pasteurized as provided in Regulation .21B(13) of this chapter. (3) The design and operation of all pasteurization equipment and all appurtenances to it shall comply with the applicable specifications and operational procedures as outlined in Appendices H and I of the Grade “A” Pasteurized Milk Ordinance. K. Cooling of Milk Products and Frozen Desserts Mix. (1) Raw milk products shall be maintained at 45°F or less until processed. (2) Pasteurized milk products and frozen desserts mix shall be cooled immediately, in approved equipment, to a temperature of 45°F or less. (3) Pasteurized milk and frozen desserts mix shall be stored at a temperature of 45°F or less and maintained at that temperature until further processed. (4) A room or tank in which products or frozen desserts mix are stored shall be equipped with an accurate thermometer. (5) A mix which is not frozen at the plant at which it is pasteurized shall be: (a) Transported to the place of manufacturing or freezing in sealed containers; (b) Handled in a sanitary manner; and (c) Stored at a temperature of 45°F or less until frozen. (6) Except for sampling, dipping from containers of pasteurized mix is prohibited. L. Container Packaging, Closure, Sealing, and Storage. (1) Closing or sealing of frozen desserts containers shall be done in a sanitary manner. (2) The closing or sealing of individual containers of frozen desserts shall be done by methods which preclude product contamination. (3) Frozen desserts shall be stored in a sanitary manner. M. Personnel Cleanliness. (1) Hand Washing. (a) Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination. (b) An employee may not resume work after visiting the toilet room without thoroughly washing the employee’s hands. (2) Garments and Hair Coverings. (a) An individual engaged in processing, pasteurization, handling, storage, transportation, or packaging of milk products, frozen dessert ingredients or frozen desserts, containers, utensils, or equipment shall wear clean outer garments and a head covering. (b) An employee with long hair shall wear hair restraints. (3) The use of tobacco by any person while engaged in the processing of milk products, frozen desserts ingredients, or frozen desserts is prohibited. #### Regulation .26-2 Frozen Desserts Plants — Operation and Transportation Requirements. *COMAR 10.15.05.26-2* A. Packaging, Overflow, and Spillage. (1) Packaging. (a) The filling of frozen desserts containers shall be done only by approved mechanical equipment or by methods which preclude contamination. (b) Frozen desserts shall be packaged in containers which protect the contents from contamination. (c) Frozen desserts or frozen desserts mix: (i) May be transported in sealed containers in a sanitary manner from one plant to another for further processing or packaging; and (ii) Shall be stored in a sanitary manner. (2) Milk products, frozen desserts, or their ingredients which have been spilled, overflowed, or leaked shall be discarded and may not be sold for human consumption. B. Vehicles. (1) Vehicles used for transportation of frozen desserts mix shall be constructed and operated so that the frozen desserts mix is: (a) Maintained at 45°F or less; and (b) Protected from; (i) Sun; (ii) Freezing; and (iii) Contamination. (2) Vehicles used for transportation of frozen desserts mix shall be kept clean. (3) Substances capable of contaminating mix or frozen desserts or their ingredients may not be transported with frozen desserts mixes in a manner which permits contamination. (4) Vehicles transporting frozen desserts or mix to wholesale or retail outlets shall have the name and address of the distributor prominently displayed on them. C. Transferring and Dispensing Frozen Desserts. (1) Except for in a sanitary room or enclosure under approved conditions a person may not: (a) Transfer frozen desserts from one container to another; or (b) Package frozen desserts: (i) On the street; or (ii) In any open vehicle. (2) The direct sale of frozen desserts in packages, cones, or servings to the consumer may take place at roadside stands or concessions where the sanitary conditions are approved by the Secretary. D. Surroundings. (1) Frozen desserts plant surroundings shall be kept clean, neat, and free from conditions which might attract or harbor flies or other insects and rodents, or which otherwise constitute a nuisance. (2) Roads, driveways, yards, and parking areas adjacent to the plant shall be: (a) Paved or otherwise treated to prevent dust; and (b) Smooth and well drained to prevent accumulation of stagnant liquid. #### Regulation .27 Inspection of Frozen Dessert Plants. *COMAR 10.15.05.27* A. Upon application for a frozen desserts license, every plant shall be inspected to determine compliance with these regulations. Following the issuance of a license, every plant shall be inspected at least once every 3 months. B. If violations are found, notice shall be given as provided in the Frozen Desserts Law, Health-General Article, §21-813, Annotated Code of Maryland. C. Every licensee shall permit access to all parts of the establishment, and shall furnish the Secretary upon his request, for official use only: (1) A true statement of actual quantities of milk products, mix, or frozen desserts used or produced; (2) Sources of milk products, ingredients, or mix; (3) Inspection and tests; (4) Past records; and (5) Pertinent information as to persons employed. #### Regulation .28 License. *COMAR 10.15.05.28* A. Before engaging in the business of manufacturing any frozen desserts mix or frozen dessert regardless of the name under which the product is sold, every person shall first obtain a license from the Maryland Department of Health, Office of Environmental Programs, Division of Milk Control. B. Only a person who complies with the requirements of this regulation is entitled to receive and retain a license. C. Suspension — Revocation of License. A license may be suspended or revoked by the Secretary as follows: (1) Upon the violation by the holder of any of the provisions of this law and regulations; (2) Immediately when an imminent health hazard is found to exist; or (3) For interference with the Secretary in the performance of his duties. #### Regulation .29 Sampling, Enforcement, and Reinstatement of License. *COMAR 10.15.05.29* A. Frequency of Sampling. Pursuant to Health-General Article, §21-804, Annotated Code of Maryland, during any consecutive 6-month period at least two samples of frozen desserts mix and frozen desserts shall be taken from each wholesale frozen dessert manufacturer. Samples of milk and milk products used as ingredients in frozen desserts shall be taken periodically. B. Enforcement. (1) In accordance with Health-General Article, §21-813, Annotated Code of Maryland, the licensee shall be notified of violations. (2) Whenever two of the last four consecutive samples of different batches of the same flavor of the same product, taken on separate days, exceed bacteria count, coliform determinations, or temperature standards as provided in Regulation .25 of this chapter, the licensee shall be notified of the results by mail and ordered to appear before the Secretary to review possible causes. At the same time, the licensee shall be warned that should the results of the next sample, collected within 14 days of the meeting, violate the standards by three of the last five bacteria counts, coliform determinations, or cooling temperatures, his license may be suspended. The suspension shall remain in effect so long as two of the last four consecutive samples exceed the limit of the standards. (3) Failure to appear, without due notification, shall be cause for immediate suspension. (4) Upon repeated violations, the Secretary may revoke a license following reasonable notice to the licensee and an opportunity for a hearing. This section is not intended to preclude the institution of court action. The Secretary may forego suspension of the license provided the product or products in violation are not sold, offered for sale, or given away. (5) Whenever a phosphatase test is positive the cause shall be determined. When the cause is improper pasteurization, it shall be corrected and any product involved may not be sold, offered for sale, or given away. C. Reinstatement of License. (1) In accordance with Health-General Article, §21-814, Annotated Code of Maryland, any license holder whose license has been suspended may make written application at any time for the reinstatement of his license. When the license suspension has been due to a violation of any of the bacteria, coliform, or cooling temperature standards, the Secretary, within 1 week after the receipt of a written application for reinstatement of license, shall issue a temporary license by letter, after determining by an inspection of the facilities and operation methods that the conditions responsible for the violation have been corrected. Samples shall then be taken at the rate of not more than two per week on separate days within a 3-week period, and the Secretary shall reinstate the license upon compliance with the appropriate standard as determined in accordance with §B of this regulation. (2) Whenever the license suspension has been due to a violation of a requirement other than the bacteriological, coliform, or cooling temperature standards, the application shall contain a written statement of the effect that the violation has been corrected. Within 1 week of the receipt of the application, the Secretary shall make an inspection of the applicant's establishment and as many additional inspections thereafter as are deemed necessary to determine that the applicant's establishment is complying with the requirements. (3) When the findings justify, the license shall be reinstated. #### Regulation .30 Frozen Desserts and Frozen Desserts Mix Which May Be Sold. *COMAR 10.15.05.30* Only frozen desserts and frozen desserts mix manufactured by a licensed wholesale frozen desserts manufacturer or retail frozen desserts manufacturer shall be sold to the final consumer, or to restaurants, soda fountains, grocery stores, or similar establishments. #### Regulation .31 Future Frozen Desserts Plants: Submission of Plans. *COMAR 10.15.05.31* Properly prepared plans for all frozen desserts plants regulated under these regulations, which are hereafter constructed, reconstructed, or extensively altered, shall be submitted to the Secretary for written approval before work is begun. #### Regulation .32 Personnel Health. *COMAR 10.15.05.32* A. A person affected with any disease in a communicable form, or who is a carrier of a communicable disease, may not work at any frozen desserts plant in any capacity which brings him in contact with the production, handling, storage, or transportation of milk, milk products, other frozen dessert ingredients, frozen desserts, or frozen desserts mix containers, equipment, and utensils. B. A plant operator may not employ in this capacity any infected person, or any person suspected of having any disease in a communicable form, or of being a carrier of a communicable disease. C. Any permit holder, in whose frozen desserts plant any communicable disease occurs, or who suspects that any employee has contracted any disease in any form, or has become a carrier of a disease, shall notify the Secretary immediately. #### Regulation .33 Procedure when Infection is Suspected. *COMAR 10.15.05.33* When reasonable cause exists to suspect the possibility of transmission of infection from any person concerned with the handling of milk, milk products, other than frozen dessert ingredients, frozen desserts, or frozen desserts mix, the Secretary is authorized to require any or all of the following measures: (1) The immediate exclusion of that person from product handling; (2) The immediate exclusion of the products concerned from distribution and use; and (3) Adequate medical and bacteriological examination of the person, of his associates, and of his and their body discharges. #### Regulation .34 Dispensing Freezers When Used in Food Service Facilities. *COMAR 10.15.05.34* When a dispensing freezer is used in a food service facility, it shall be exempt from the provisions of Regulations .22 — .24, .26 — .33, and .35 of this chapter. The operation and maintenance of this equipment shall comply with the provisions of COMAR 10.15.03. #### Regulation .35 Retail Frozen Desserts Manufacturers. *COMAR 10.15.05.35* Retail frozen dessert manufacturers shall be exempt from the provisions of Regulations .22—.24, .26—.27 and .31—.33 under this chapter. The sanitation requirements and operation and maintenance of equipment of retail frozen dessert manufacturers shall comply with the provisions of COMAR 10.15.03. Retail frozen dessert manufacturers shall manufacture frozen desserts from Grade “A” milk or milk products as defined in COMAR 10.15.06.02 or manufactured grade milk or milk products as defined in COMAR 10.15.09.02. ### Chapter 06 — Production, Processing, Transportation, Storage, and Distribution of Grade “A” Milk **Authority:** Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-406, and 21-428, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1972 **Administrative History:** Regulations .01 and .03A amended effective February 2, 1977 (4:3 Md. R. 145) **Administrative History:** Regulation .01AA, FF adopted effective August 25, 1978 (5:17 Md. R. 1330) **Administrative History:** Regulation .01-1 adopted effective February 12, 2007 (34:3 Md. R. 299) **Administrative History:** Regulation .01-2 adopted effective February 12, 2007 (34:3 Md. R. 299) **Administrative History:** Regulation .03A amended effective October 20, 1997 (24:21 Md. R. 1449) **Administrative History:** Regulation .03C amended effective August 25, 1978 (5:17 Md. R. 1330) **Administrative History:** Regulation .03D, E effective September 6, 1974 **Administrative History:** Regulation .03F adopted effective January 11, 1980 (7:1 Md. R. 44) **Administrative History:** Regulation .03F repealed effective October 20, 1997 (24:21 Md. R. 1449) **Administrative History:** Regulation .06 amended as an emergency provision effective April 6, 2006 (33:9 Md. R. 795); amended permanently effective August 28, 2006 (33:17 Md. R. 1436) **Administrative History:** Regulation .06C amended effective September 5, 1988 (15:18 Md. R. 2148); September 13, 1993 (20:18 Md. R. 1430) **Administrative History:** Regulation .08B amended effective August 24, 1979 (6:17 Md. R. 1394) **Administrative History:** Regulations .01—.11 repealed and new Regulations .01—.19 adopted effective March 19, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .03A amended effective March 7, 2011 (38:5 Md. R. 317) **Administrative History:** Regulation .03A amended effective October 15, 2012 (39:20 Md. R. 1306) **Administrative History:** Chapter revised effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .02B amended effective May 18, 2020 (47:10 Md. R. 517); August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation .03 amended effective August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation .03A amended effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .03B amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .05B amended effective August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation .10D amended effective August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation .11 amended effective August 5, 2024 (51:15 Md. R. 708) **Administrative History:** Regulation .16E adopted effective May 18, 2020 (47:10 Md. R. 517) **Administrative History:** Regulation .16F amended effective May 18, 2020 (47:10 Md. R. 517) #### Regulation .01 Scope. *COMAR 10.15.06.01* This chapter: A. Governs permits for the sale of Grade “A” milk and milk products, as set forth in Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland; B. Requires a permit for the sale of Grade “A” milk and milk products; C. Regulates the inspection of Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products; and D. Sets forth: (1) Standards for Grade “A” milk and milk products; (2) The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of Grade “A” milk and milk products; (3) Penalties pursuant Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and (4) Requirements for Grade “A” dairy farms and milk facilities that produce, process, transport, store, or distribute Grade “A” milk or milk products. #### Regulation .02 Definitions. *COMAR 10.15.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Bobtailer” means a person who operates or controls a Grade “A” milk route, and distributes Grade “A” pasteurized milk products that the person buys from a Grade “A” distributor or milk processor. (2) “Bulk milk hauler/sampler” means a person who: (a) Collects official samples; (b) Transports raw milk from a farm or raw milk products to or from a milk plant, receiving station, or transfer station; (c) Possesses a permit from any state to sample raw milk or raw milk products; and (d) Possesses a Maryland Bulk Milk Hauler license if they are sampling milk or raw milk products in Maryland. (3) “Certified industry dairy farm inspector” means an individual who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to carry out the inspections of dairy farms. (4) “Dairy farm” means a place where at least one cow, goat, or other hoofed mammal is kept, and from which the milk is sold or offered for sale. (5) “Department” means the Maryland Department of Health or the Department's designee. (6) “Extensive alteration” means the adding or tearing down of walls, plumbing, or other structural components of a dairy farm or milk plant. (7) “Grade “A” distribution station” means a place or vehicle where, for redistribution and sale, Grade “A” pasteurized milk products routinely are received, stored, or transferred. (8) “Grade “A” fluid milk” means pasteurized homogenized or pasteurized non-homogenized Grade “A” milk, cream, or half and half that has been processed to produce whole milk, low fat milk, or nonfat milk. (9) “Grade “A” milk or milk products” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance. (10) “Impound” means to detain and hold milk or milk products under the authority of the Secretary, as provided under Health-General Article, §21-428, Annotated Code of Maryland. (11) “Improper handling” means Grade “A” milk or a milk product intended for human consumption that: (a) Has been adulterated; (b) Has been misbranded; (c) Has not been kept at the required temperature; (d) Is injurious to health if consumed; or (e) Is otherwise unsafe. (12) “Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station. (13) “Milk” means the milk of a cow, goat, or other hoofed mammal that is produced, processed, pasteurized, bottled, packaged, or prepared in accordance with the Grade “A” Pasteurized Milk Ordinance. (14) “Milk facility” means a: (a) Milk plant; (b) Grade “A” distribution station; (c) Receiving station; (d) Transfer station; (e) Milk processor; or (f) Milk tank truck cleaning facility. (15) “Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk. (16) Milk Plant. (a) “Milk plant” means a place where, for distribution, milk products are: (i) Processed; (ii) Pasteurized; (iii) Bottled or packaged; or (iv) Prepared. (b) “Milk plant” does not include a place where milk products are sold at retail only. (17) “Milk processor” means a person who owns, operates, or controls a milk plant. (18) “Milk producer” means a person who: (a) Operates a dairy farm; and (b) Provides, sells, or offers milk for sale to a: (i) Milk plant; (ii) Receiving station; or (iii) Transfer station. (19) “Milk tank truck” means a truck and its equipment that are used to transport milk or milk products. (20) “Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized. (21) “Milk transportation company” means a person who is responsible for a milk tank truck. (22) “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department. (23) “Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of: (a) Producer samples of Grade “A” raw milk for pasteurization; or (b) Commingled milk tank truck samples of Grade “A” raw milk. (23-1) “On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer. (23-2) Pasteurization. (a) “Pasteurization” has the meaning stated in 21 CFR §131.3. (b) “Pasteurization” includes any other process found equivalent to pasteurization for milk and milk products as stated in 21 U.S.C. §343(h) (24) “Permit” means an official document issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit. (25) “Permittee” means a person who holds a permit. (26) Person. (a) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (b) “Person” includes: (i) An operator of a facility that is owned by a State or local unit of government; or (ii) A State or local unit of government if the State or local unit of government is the operator of the facility. (27) “Raw milk” means unpasteurized milk. (28) “Receiving station” means a place where, for delivery to a milk plant, raw milk is collected, cooled, and stored. (29) “Sale” or “sell” means a transaction that involves the: (a) Transfer, dispensing, or serving of milk and milk products with or without charge; or (b) Right to acquire milk and milk products: (i) Through barter or contractual arrangement; or (ii) In exchange for any other form of compensation including, but not limited to, an agistment agreement, which is the sale of shares or interest in a cow, goat, or other lactating hoofed mammal, or herd of cows, goats, or other lactating hoofed mammals. (30) “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms. (31) “Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year. (32) “Secretary” means the Secretary of Health or the Secretary's designee. (33) “Sell-by date” means the end of the sell-by period. (34) “Transfer station” means a place where milk is transferred directly from a milk tank truck to another milk tank truck for delivery to a milk plant. (35) “Ultra-pasteurization” means the process of heating milk or milk product in properly designed and operated equipment to a minimum of 280°F for at minimum two seconds, either before or after packaging, so as to produce a milk or milk product which has an extended shelf-life under refrigerated conditions. #### Regulation .03 Incorporation by Reference. *COMAR 10.15.06.03* In this chapter the following documents are incorporated by reference: A. Grade “A” Pasteurized Milk Ordinance, 20239evision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration); B. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f, as amended; C. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended; D. FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252, as amended; and; E. 21 CFR §§130—131, as amended. #### Regulation .04 General Requirements. *COMAR 10.15.06.04* A. The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth at and in compliance with the standards, requirements, and procedures specified at: (1) Health-General Article, Title 21, Annotated Code of Maryland; (2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f; (3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535); (4) Grade “A” Pasteurized Milk Ordinance; and (5) FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252. B. A person engaged in an occupation involving Grade “A” milk shall conduct all Grade “A” milk activities as set forth at and in compliance with the standards, requirements, and procedures specified at: (1) Health-General Article, Title 21, Annotated Code of Maryland; (2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f; (3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535); and (4) Grade “A” Pasteurized Milk Ordinance. #### Regulation .05 Standards for Milk Products. *COMAR 10.15.06.05* A. A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards, requirements, and procedures established by the: (1) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f; (2) Nutrition Labeling and Education Act of 1990 (Public Law 101-535); (3) Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland; and (4) Grade “A” Pasteurized Milk Ordinance. B. A bulk milk hauler/sampler shall ensure that: (1) Bulk raw milk is delivered or received by the processor or receiving station within 12 hours of pickup route completion; (2) Bulk raw milk is picked up from every dairy farm at least once every 72 hours; and; (3) The temperature of the bulk raw milk does not exceed 45F. C. The person in charge of an official laboratory or officially designated laboratory shall ensure that: (1) The laboratory is operated according to the requirements established by the Grade “A” Pasteurized Milk Ordinance; and (2) All raw milk for pasteurization, all pasteurized milk and milk products, and all dairy product containers and lids are tested according to the requirements established by the Grade “A” Pasteurized Milk Ordinance. #### Regulation .06 Permits Required. *COMAR 10.15.06.06* A. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before that person may: (1) Be a: (a) Bobtailer; (b) Bulk milk hauler/sampler; (c) Certified industry dairy farm inspector; (d) Milk processor; (e) Milk producer; or (f) Seasonal milk producer; or (2) Operate a: (a) Grade “A” distribution station; (b) Milk tank truck cleaning facility; (c) Milk transportation company; (d) Receiving station; or (e) Transfer station. B. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, for a milk tank truck. C. Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for: (1) A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter; (2) A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area; (3) A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if: (i) The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and (ii) The milk product is received from a permittee; or (4) An individual who only transports milk in a sealed tanker to a milk plant, receiving station, or transfer station and not producers’ samples. #### Regulation .07 Inspection and Evaluation of Milk Production and Transportation. *COMAR 10.15.06.07* A. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect: (1) A milk tank truck; (2) A milk producer; (3) A seasonal milk producer; (4) A transfer station; (5) A milk tank truck cleaning facility; (6) A milk plant; and (7) A receiving station. B. The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until production of milk for sale has ceased. C. The Secretary shall inspect a Grade “A” distribution station at least once every 6 months. D. The Secretary shall inspect a bobtailer at least once every 12 months. E. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall evaluate: (1) The ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling; (2) The pick-up and sampling procedures that a bulk milk hauler/sampler performs; and (3) The sampling procedures of the industry plant sampler. F. The Secretary shall inspect and evaluate a bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B. G. The Secretary shall inspect a milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance and Appendix B. H. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N, the Secretary shall evaluate: (1) Laboratories performing Grade “A” milk product testing for official use; (2) Laboratories performing drug residue testing; and (3) Laboratory analysts performing testing as required by the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix N. #### Regulation .08 Improper Handling of Milk Products. *COMAR 10.15.06.08* A. Under Health-General Article, §21-428, Annotated Code of Maryland, and to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, the Secretary shall impound Grade A milk or milk products intended for human consumption due to improper handling. B. After impounding the Grade A milk or milk product, the Secretary may issue an order to: (1) Dispose of the milk or milk product; (2) Make the milk or milk product unusable for consumption; or (3) Under Health-General Article, §21-428, Annotated Code of Maryland, impose a civil monetary penalty, as set forth in §C of this regulation. C. The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents. D. A person subject to an impoundment order may seek legal recourse as set forth at Health-General Article, §21-428, Annotated Code of Maryland, by: (1) Appealing a civil penalty; or (2) Bringing an action for damages. #### Regulation .09 Labeling of Milk. *COMAR 10.15.06.09* A permittee shall ensure that milk product labels conform to the standards and requirements established by the: A. Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f; B. Nutrition Labeling and Education Act of 1990 (Public Law 101-535); C. Grade “A” Pasteurized Milk Ordinance; and D. Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland. #### Regulation .10 Dating of Grade “A” Fluid Milk. *COMAR 10.15.06.10* A. Unless approved by the Department as described in §B of this regulation, a person may not sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing. B. In order to sell, deliver, or offer Grade “A” milk or milk products that are cooled to, packaged, and stored at 45°F or less for sale after 18 days from the date of processing, an applicant shall: (1) Submit to the Department: (a) A written request; and (b) A shelf life study to show that the product meets standards set forth in this chapter; and (2) Be approved by the Department. C. A permittee shall conspicuously and legibly mark the cap or non-glass container of Grade “A” fluid milk with the words “Sell by”, followed by the designation of the month and the day of the month after which the product may not be sold, delivered, or offered for sale. D. Milk products exempt from dating requirements are: (1) Cultured milk products and eggnog; (2) Milk and dairy products as defined by 21 CFR §§130—131, which have been subjected to aseptic processing and packaging; and (3) Milk and dairy products as defined in 21 CFR §131.3(c), which have been subjected to ultra-pasteurization. #### Regulation .11 Sale and Handling of Milk by Food Service Facilities. *COMAR 10.15.06.11* A. Except as provided in §B of this regulation, a person may not offer Grade “A” fluid milk for sale beyond the sell-by date. B. The following establishments may use or serve Grade “A” fluid milk up to 4 days beyond the sell-by date: (1) Food service facilities; (2) Hospitals; (3) Schools; (4) Institutions; and (5) Places where milk is consumed on the premises. C. An establishment listed in §B of this regulation shall ensure that Grade “A” fluid milk is used by the establishment not later than 4 days beyond the sell-by date. #### Regulation .12 Sale of Raw Milk. *COMAR 10.15.06.12* A. Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption. B. A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted: (1) Receiving station; (2) Transfer station; (3) Milk plant; or (4) Milk marketing agency. #### Regulation .13 Dairy Farm Construction and Plan Submission. *COMAR 10.15.06.13* Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a dairy farm, a person shall submit to the Department: A. A plan and specifications before: (1) Constructing or reconstructing a milk house, milking barn, milking stable, or milking parlor; (2) Converting or remodeling an existing building or structure for use as a milk house, milking barn, milking stable, or milking parlor; or (3) Adding, modifying, or replacing: (a) A bulk milk tank; (b) A milking system; (c) Any part of a milking system; (d) A washing system; (e) Any part of a washing system; or (f) A cooling system, including a plate cooler or bulk tank cooling system; and B. A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work; C. Contact information for the dairy farm, including: (1) The full name, title, and telephone number of each applicant; (2) The name of the dairy farm; (3) The mailing address; (4) The location; and (5) Directions to the site; D. A site drawing showing the location of the milk house, milking barn, milking stable, milking parlor, and each animal housing area, with approximate distances in feet, to: (1) Manure pits; (2) Cow yards; (3) Silos; (4) Wells or other approved water systems; (5) Septic systems; (6) Frost free style watering hydrants; (7) Ditches; and (8) Streams; E. A detailed drawing of the interior of the milk house, milking barn, milking stable, milking parlor, and each animal housing area indicating dimensions and showing the location of: (1) Equipment; (2) Pre-coolers; (3) Floor drains; (4) Lighting; (5) Hose bibs; (6) Watering troughs; (7) Frost free style watering hydrants; (8) Washing systems; (9) Chemical dispensers; (10) Compressors; (11) Back flow prevention devices; and (12) Toilets; F. For pipeline and milking system installations: (1) The make, model number, quantity, and specifications of milking equipment including pipeline and milking units; (2) The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute; (3) A drawing of the parlor or barn showing the location of: (a) Milking equipment; (b) Pipeline, including size and length of the piping; (c) Wash line, including size and length of the wash line; (d) Receiver, if applicable; (e) Pre-cooler, if applicable; (f) Any other milk equipment; and (g) The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn; (4) A description and diagram of the location of the back flow protection methods or devices that will be installed to protect the potable water supply on all plate coolers, chemical pumps, water lines, and other fixtures; (5) The type, such as gas or electric, and capacity of the hot water heating system; and (6) Information and specifications for booster or supplemental heating systems, if utilized; G. For bulk tank/milk cooling systems installation: (1) A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank; (2) Specific floor, wall, and ceiling finishes, if part of a new installation; (3) Bulk tank specifications, including make, model number, and capacity; (4) Cooling system specifications, including make, model number, and capacity; and (5) Pre-cooler type and British thermal units capability, if applicable. #### Regulation .14 Dairy Farm Requirements. *COMAR 10.15.06.14* A milk producer shall ensure that: A. Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .13 of this chapter, as applicable; B. Water used at a dairy farm shall: (1) Be obtained from a water supply system that complies with: (a) Environment Article, Title 9, Annotated Code of Maryland; (b) COMAR 26.04.04; and (c) The Grade “A” Pasteurized Milk Ordinance; (2) Be installed in a manner that prevents backflow or back-siphoning; (3) Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system; (4) Provide hot and cold running water in areas where milk processing equipment is washed; and (5) Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system; C. Hand sinks shall have: (1) Either: (a) Hot and cold running water under pressure; or (b) Warm running water; (2) A supply of hand-cleaning soap or detergent; and (3) A sanitary means of drying hands, such as individual towels or a hand-drying device; D. A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; E. Toilet facilities, if any, are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; F. Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and G. Electrical systems comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance. #### Regulation .15 Milk Facility Construction and Plan Submission. *COMAR 10.15.06.15* Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department: A. Plans and specifications before: (1) Constructing, reconstructing, or extensively altering a milk facility; (2) Converting or remodeling an existing building or structure for use as a milk facility; (3) Adding, replacing, relocating, or modifying a milk facility process; or (4) Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system; B. Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work. C. Contact information for the facility, including: (1) The full name, title, and telephone number of each applicant; (2) The name of the plant; (3) The mailing address; (4) The location; and (5) Directions to the site; D. A narrative describing the scope and purpose of the project, including a projected time line from start to completion; E. An estimate of finished product output per day; F. Sample product labels for each product; G. A list of: (1) All products to be produced; (2) Raw cream and skim, condensed, or any other milk or milk products to be sold; and (3) Single service container sources; H. A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for: (1) Processing; (2) Chemical storage; (3) Dry storage; (4) Ingredient and product storage; (5) Receiving; (6) Load out; (7) Laboratories; (8) Offices; (9) Restroom facilities; (10) Lockers or a facility for the storage of personal items; and (11) Employees to eat and drink beverages; I. A scale drawing showing the location of all equipment, including: (1) Pasteurizers and sterile systems; (2) Milk processing equipment; (3) Fillers; (4) Raw and pasteurized tanks and silos; (5) Clean-in-place (CIP) systems; (6) Glycol water tanks; (7) Recirculating cooling water tanks; (8) Boilers; (9) Boiler makeup tanks; (10) Culinary steam systems; and (11) Blow mold systems; J. A scale drawing showing the location of plumbing and plumbing fixtures, including: (1) Water lines; (2) Sewer lines; (3) Hand sinks; (4) Toilets; (5) Utility sinks; (6) Utensil washing sinks; (7) Floor drains; (8) Floor sinks; (9) Hose stations; and (10) All back flow prevention devices; K. A legend for each drawing; L. Specifications for: (1) Ventilation including, but not limited to, the type and location of: (a) An air filter; (b) An air pump; and (c) A compressor; (2) Construction materials for the building and interior finishes; and (3) Pasteurizer plate coolers, if separate from the pasteurization system; M. A list and description of all boiler, glycol, and recirculating water additives and water treatment; N. A description of the: (1) Type of disposal for wastewater and sewage; (2) Source and system for the facility’s potable water supply; (3) Lighting fixtures and placement; and (4) Recirculating cooling system; O. Specification sheets, including manufacturer and model number of all milk facility equipment; P. A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including: (1) Reclamation systems; (2) Standardization procedures or formulation procedures, or both; (3) Vitamin addition protocol; and (4) Draining of product lines; Q. Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component; R. Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment; S. Information and drawings on how separation from product lines will be accomplished, if applicable; T. Written step-by-step standard operating procedures for: (1) Receiving, processing, storing, and packaging of each project; (2) Drug residue testing; (3) Cleaning and sanitization for all equipment; (4) Cleaning and sanitization for the facility; (5) Product trace back, inclusive of production or make sheet; and (6) Product recall; U. A pest control program; and V. Employee training and personal hygiene practices. #### Regulation .16 Milk Physical Plant Requirements. *COMAR 10.15.06.16* A. Water used at a milk facility shall: (1) Be obtained from a potable water supply system that complies with: (a) Environment Article, Title 9, Annotated Code of Maryland; (b) COMAR 26.04.04; and (c) The Grade “A” Pasteurized Milk Ordinance; (2) Be installed in a manner that prevents backflow or back-siphoning; and (3) Be separate from a non-potable water supply system so that non-potable water cannot be drawn or discharged into the potable water supply system; (4) Provide hot and cold running water in areas where milk processing equipment is washed; and (5) Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system. B. Hand sinks shall have: (1) Either: (a) Hot and cold running water under pressure; or (b) Warm running water; (2) A supply of hand-cleaning soap or detergent; and (3) A sanitary means of drying hands, such as individual towels or a hand-drying device. C. A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance. D. Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations. E. Toilet facilities shall: (1) Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance; (2) For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and (3) For a milk plant that is an on-farm processor, if not located within the physical plant building: (a) Be located within 500 feet of the physical plant building; (b) Be accessible at all times that the plant is in operation; (c) Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and (d) Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of COMAR 26.04.02. F. Electrical systems at the facility shall: (1) Comply with State and local electrical laws, ordinances, and regulations; (2) Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where: (a) Milk or milk products are handled, processed, packaged, or stored; or (b) Containers, utensils, and equipment are washed; and (3) Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms. #### Regulation .17 Plan Review Approval. *COMAR 10.15.06.17* A. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department. B. An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .13—.16 of this chapter. C. The Department shall: (1) Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .13—.16 of this chapter; and (2) Inform the applicant: (a) That the plan has been received; (b) If additional information is required to complete the plant review; (c) Whether the plan is approved or denied; and (d) Of the appeal process if the plan is denied. #### Regulation .18 Confidentiality. *COMAR 10.15.06.18* The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland. #### Regulation .19 Suspension and Revocation of Permits. *COMAR 10.15.06.19* A. When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §21-211, 21-418, or 21-419, Annotated Code of Maryland or the Grade “A” Pasteurized Milk Ordinance. B. Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland. C. The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period. D. If a permit has been suspended more than once, the Secretary may revoke the permit. E. The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked. F. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the: (1) Department shall: (a) Summarily suspend the permit; (b) Order the permittee to cease operation immediately; and (c) Promptly provide the permittee with: (i) A written notice of the suspension of the permit; (ii) The reasons for the suspension; and (iii) An opportunity to be heard; and (2) Permittee shall immediately cease operation upon the receipt of the summary suspension order. #### Regulation .20 Appeals Process. *COMAR 10.15.06.20* In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been: A. Denied; B. Suspended; or C. Revoked. ### Chapter 07 — Shellfish Sanitation **Authority:** Health-General Article, §§18-102, 21-211, 21-234, 21-235, 21-304, 21-305, 21-321, and 21-346—21-350, Annotated Code of Maryland **Administrative History:** Effective date: September 1, 1967 **Administrative History:** Amended effective December 1, 1970 **Administrative History:** Regulations .01—.12 amended effective May 26, 1976 (3:11 Md. R. 592) **Administrative History:** Regulations .02—.06 amended as an emergency provision effective August 20, 1985 (12:19 Md. R. 1843); emergency status expired December 18, 1985 **Administrative History:** Regulations .02—.06 amended effective March 10, 1986 (13:5 Md. R. 543) **Administrative History:** Regulation .03C amended as an emergency provision effective June 1, 1978 (5:12 Md. R. 964); adopted permanently effective September 22, 1978 (5:19 Md. R. 1445) **Administrative History:** Regulations .01—.12 repealed and new regulations .01—.06 adopted effective November 6, 2006 (33:22 Md. R. 1733) **Administrative History:** Regulation .01A amended effective November 17, 2008 (35:23 Md. R. 2013); October 16, 2009 (36:20 Md. R. 1528); November 14, 2011 (38:23 Md. R. 1421); January 6, 2014 (40:26 Md. R. 2164); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); August 26, 2019 (46:17 Md. R. 726); July 24, 2023 (50:14 Md. R. 593); February 2, 2026 (53:2 Md. R. 61) **Administrative History:** Regulation .02B amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012) **Administrative History:** Regulation .02B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547) **Administrative History:** Regulation .04 amended effective November 17, 2008 (35:23 Md. R. 2013) **Administrative History:** Regulation .04D amended effective October 16, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .04E amended as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); amended permanently effective August 22, 2011 (38:17 Md. R. 1012) **Administrative History:** Regulation .06 adopted as an emergency provision effective June 1, 2011 (38:15 Md. R. 898); adopted permanently effective August 22, 2011 (38:17 Md. R. 1012) **Administrative History:** Regulation .06B amended as an emergency provision effective June 1, 2013 (40:13 Md. R. 1072); amended permanently effective September 30, 2013 (40:19 Md. R. 1547) #### Regulation .01 Incorporation by Reference. *COMAR 10.15.07.01* In this chapter, the following documents are incorporated by reference: A. National Shellfish Sanitation Program (NSSP) Guide for the Control of Molluscan Shellfish 2023 Revision (US Food and Drug Administration), Section I. Purpose & Definitions and Section II. Model Ordinance except for Chapter IV, Shellstock Growing Areas; and B. American Public Health Association, Recommended Procedures for the Examination of Sea Water and Shellfish, 4th Edition, 1970. #### Regulation .02 Definitions. *COMAR 10.15.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Dealer” means a person who is issued a certificate by the Department for the activities of shellstock shipper, shucker-packer, repacker, reshipper, or depuration processor. (2) “Department” means the Maryland Department of Health or the Department's designee. (3) “Mechanical refrigeration” means the removal of heat by using a refrigerant subjected to cycles of refrigerating thermodynamics and employing a mechanical compressor. (4) Person-in-Charge. (a) “Person-in charge” means the licensee or other person responsible for the operation of the shellfish plant. (b) “Person-in-charge” includes the dealer as used in the National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance. (5) Shellfish Aquaculture Harvester Permittee. (a) “Shellfish aquaculture harvester permittee” means a person who is issued a permit by the Department of Natural Resources in accordance with COMAR 08.02.23.04 to harvest shellfish from a submerged land lease or water column lease. (b) “Shellfish aquaculture harvester permittee” includes a person registered to harvest shellfish from the lease cited on a shellfish harvester aquaculture permit. (6) “Temperature control” means the management of the temperature of shellstock by means of ice, mechanical refrigeration, or other approved means necessary to lower and maintain the temperature of the shellstock to 50°F (10°C) or below. #### Regulation .03 Compliance with Other Chapters. *COMAR 10.15.07.03* A. The person-in-charge shall ensure that shellfish are processed and the facilities and equipment of a shellfish plant are designed, operated, and maintained in compliance with: (1) This chapter; (2) COMAR 10.15.04 and 10.15.10; and (3) The National Shellfish Sanitation Program Guide for the Control of Molluscan Shellfish, Model Ordinance. B. If a conflict occurs between the requirements of this chapter and COMAR 10.15.04 or 10.15.10 regarding shellfish plants or the processing of shellfish, this chapter takes precedence. #### Regulation .04 Licenses and Certifications. *COMAR 10.15.07.04* A. Except for a licensed harvester delivering the harvester's catch to a certified dealer on the day of harvest, a person may not offer shellfish for sale in-State or interstate unless the person is licensed and certified in accordance with this chapter. B. In order to operate a shellfish plant, a person shall obtain a food processing plant license pursuant to the provisions of: (1) Health-General Article, §21-305, Annotated Code of Maryland; (2) COMAR 10.15.04; and (3) This chapter. C. The person-in-charge shall ensure that: (1) Shellfish are not purchased, sold, or processed without the: (a) License required by the Health-General Article, §21-305, Annotated Code of Maryland; and (b) Certification required by this chapter; and (2) The required food processing plant license and certification are conspicuously posted in the plant. D. In order to purchase or ship shellfish products in in-State or interstate commerce, a person shall obtain certification pursuant to this chapter. E. The Department shall specify on the license and certification issued to a person operating a shellfish plant that the person is approved to operate as a: (1) Shucker-packer (SP); (2) Repacker (RP); (3) Shellstock shipper (SS); (4) Reshipper (RS); or (5) Depuration processor (DP). F. The person-in-charge shall ensure that the operations in the plant are limited to the type of shellfish operation specified on the license and certification pursuant to §E of this regulation. #### Regulation .05 Bacteriological Standards. *COMAR 10.15.07.05* A. The person-in-charge: (1) Shall ensure that shellfish are harvested, handled, and processed to meet the bacteriological standards in this regulation; and (2) May not distribute shellfish that do not meet the standards in this regulation. B. To establish whether compliance is met with the bacteriological standards for shellfish in §C of this regulation, a person shall utilize the isolation, identification, and enumeration in the American Public Health Association Recommended Procedures for the Examination of Sea Water and Shellfish, or other methods approved by the Secretary based on the ability of the methods to provide accurate and repeatable results. C. The bacteriological standards for shellfish are the following: (1) Standard plate count (SPC) may not exceed 500,000 colony-forming units per gram of shellfish; (2) Except when shellfish are further analyzed for Escherichia coli (E. coli), fecal coliform may not exceed 230 most probable number (MPN) per 100 grams of shellfish; and (3) When shellfish exceed 230 MPN fecal coliform per hundred grams and are further analyzed for E. coli, E. coli may not exceed 330 MPN per 100 grams of shellfish. D. The Department shall construe numbers of bacteria in excess of the standards set forth in §C of this regulation as rendering the product adulterated, pursuant to Health-General Article, §21-207, Annotated Code of Maryland, and unfit for human consumption. #### Regulation .06 Vibrio parahaemolyticus Control. *COMAR 10.15.07.06* A. A dealer and a shellfish aquaculture harvester permittee shall implement control measures as set forth in §B of this regulation to reduce the occurrence of Vibrio parahaemolyticus illness. B. Control Measures. (1) From June 1 through September 30, a shellfish aquaculture harvester permittee shall: (a) Protect harvested oysters from direct sun by providing shade over the area where the harvested oysters are stored; (b) Maintain air flow to the area where the harvested oysters are stored; (c) Designate a single site for landing the harvested oysters; (d) Document the harvest start time, which is the time the first oysters are removed from the water, on a harvest trip record or harvest tag; and (e) Provide the harvest time record as set forth in §B(1)(d) of this regulation to a dealer on delivery. (2) From June 1 through June 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 11:30 a.m. on the day of harvest. (3) From July 1 through August 31, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 10:30 a.m. on the day of harvest. (4) From September 1 through September 30, a shellfish aquaculture harvester permittee shall deliver harvested oysters to a dealer by 12:30 p.m. on the day of harvest. (5) From June 1 through September 30, a dealer may not: (a) Receive oysters harvested from Maryland waters: (i) After the harvest delivery times set forth in §B(2)—(4) of this regulation; and (ii) Without a harvest time record as set forth in §B(1)(d) of this regulation; or (b) Sell or ship oysters that have not reached an internal temperature of 50°F (10°C) or below. (6) From June 1 through September 30, a dealer shall: (a) Place oysters under temperature control immediately upon delivery from the shellfish aquaculture harvester permittee: and (b) Implement a HACCP plan as defined in COMAR 10.15.04 that recognizes pathogen growth of naturally occurring Vibrio bacteria present from June through September 30 as a significant hazard and includes: (i) Control measures necessary to ensure, document, and verify that the internal temperature of oysters has reached 50°F (10°C) or below within 10 hours or less after being placed under temperature control; and (ii) Corrective action to ensure that oysters that are not cooled to an internal temperature of 50°F (10°C) within 10 hours are not directed to the raw shellfish market. (7) To comply with §B(6) of this regulation, a dealer shall ensure that a temperature control mechanism for cooling and storing of oysters: (a) Maintains a temperature of 45°F; and (b) Cools oysters to an internal temperature of 50°F (10°C) in 10 hours or less. (8) A shellfish aquaculture harvester permittee who is a dealer shall comply with the requirements set forth in §B(1)—(7) of this regulation. (9) The Department may except a shellfish aquaculture harvester permittee who is a dealer from the harvest delivery times set forth in §B(2)—(4) and the receiving time set forth in §B(5)(a)(i) of this regulation if the permittee/dealer: (a) Places harvested oysters under temperature control within 5 hours of harvest start time, which is the time the first oysters are removed from the water; and (b) Implements an HACCP plan as defined in COMAR 10.15.04 that includes the control measures necessary to ensure, document, and verify that the harvested oysters are placed under temperature control within 5 hours of harvest start time. ### Chapter 08 — Farmstead Cheese Program **Authority:** Health-General Article, §§21-211, 21-234, 21-406, 21-416.1, 21-417, 21-418, 21-419,21-428, 21-434, 21-252—21-256, 21-1202, 21-1203, and 21-1215, Annotated Code of Maryland **Administrative History:** Effective date: May 4, 2009 (36:9 Md. R. 651) **Administrative History:** Regulation .01A amended effective December 28, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .04 amended effective December 28, 2009 (36:25 Md. R. 1954) **Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 407) **Administrative History:** Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .03H amended effective February 27, 2017 (44:4 Md. R. 254); May 18, 2020 (47:10 Md. R. 517) #### Regulation .01 Scope. *COMAR 10.15.08.01* This chapter: A. Establishes a farmstead cheese program; and B. Sets forth the regulation and enforcement process for: (1) The plan review process for facilities and equipment; (2) The permitting process for the manufacture of cheese made from raw milk; (3) Farmstead cheese: (a) Production; (b) Labeling; (c) Record keeping; (d) Inspections; (e) Packaging; (f) Distribution; (g) Sale; (h) Sampling; (i) Testing; and (4) Assessment of the penalties pursuant to Health-General Article, §§21-211, 21-252— 21-256, 21-418, 21-419, 21-428, 21-1202, 21-1203, and 21-1215, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.15.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Aging of cheese” means the storing and maturing of cheese under controlled conditions of temperature and humidity. (2) “Aging period” means the aging of raw milk cheese for at least 60 calendar days at a temperature of not less than 35°F. (3) “Aging room” means the area where the aging of cheese takes place. (4) “Dairy farm” means a place or premises: (a) Where one or more lactating animals, including cows, goats, sheep, water buffaloes, or other hooved mammals, are kept for milking purposes; and (b) From which the milk is sold or offered for sale. (5) “Department” means the Maryland Department of Health. (6) “Departmental inspection area” means the area in which the Department routinely makes inspections under Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland. (7) “Drug residue” means a substance that prevents the growth of bacteria in milk products. (8) “Farmstead cheese” means a cheese made on a dairy farm: (a) Using only the raw milk produced by the herd or flock on the dairy farm; and (b) That meets the definitions and standards of a hard cheese, as set forth in 21 CFR Part 133. (9) “Industry plant sampler” means: (a) An individual responsible for the collection of official samples for regulatory purposes at a plant as outlined in the Grade “A” Pasteurized Milk Ordinance, Appendix N; and (b) An employee of the plant who is evaluated a least once every 2-year period by a sampling surveillance officer or a properly delegated sampling surveillance official. (10) “Milk” means the milk of a cow, goat, or other hooved mammals. (11) “Official laboratory” means a laboratory that is a biological, chemical, or physical laboratory, which is under the direct supervision of the Department. (12) “Officially designated laboratory” means a laboratory that is a: (a) Commercial laboratory authorized to do official work by the Department; or (b) Milk industry laboratory officially designated by the Department for the examination of producer samples of raw milk for drug residue. (13) “Plant” means any place, premise, or establishment where milk or milk products are collected, handled, processed, stored, packaged or otherwise prepared for distribution as a farmstead cheese. (14) “Raw milk” means unpasteurized milk. (15) “Sanitation inspection” means an evaluation of the milk plant and associated processes in accordance with this chapter. (16) “Sanitization” means: (a) The application of any effective method or substance to properly clean surfaces for the destruction of pathogens and other microorganisms, as far as is practicable; and (b) A treatment that: (i) Does not adversely affect the equipment, the milk, milk product, or the health of consumers; and (ii) Is acceptable to the Department. #### Regulation .03 Incorporation by Reference. *COMAR 10.15.08.03* In this chapter, the following documents are incorporated by reference: A. 21 CFR Part 101, as amended; B. 21 CFR Part 110, as amended; C. 21 CFR Part 133, as amended; D. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended; E. United States Food and Drug Administration Food Compliance Program, “Domestic and Imported Cheese and Cheese Products”, November 19, 1998. F. 21 USC §§401—423, as amended; G. Food and Drug Administration Compliance Program Guidance Manual, Program 7303.803 (November 9, 2008); and H. Grade “A” Pasteurized Milk Ordinance, 2017 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), Section 8, Appendix D, Appendix G Section I, Appendix H Section II, and Appendix N only. #### Regulation .04 General Requirements. *COMAR 10.15.08.04* A. The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth and in compliance with the standards, requirements, and procedures specified in: (1) Health-General Article, Title 21, Annotated Code of Maryland; (2) Federal Food, Drug and Cosmetic Act, 21 USC §§341—350; and (3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535). B. An individual engaged in an occupation involving farmstead cheese production shall conduct all farmstead cheese production activities as set forth at and in compliance with the standards, requirements, and procedures specified in: (1) Health-General Article, Title 21, Annotated Code of Maryland; (2) Federal Food, Drug and Cosmetic Act, 21 USC §§341—350; and (3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535). #### Regulation .05 Permitting Requirements. *COMAR 10.15.08.05* A. Pursuant to Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before the person may be a: (1) Milk producer; or (2) Milk Processor — Farmstead Cheese Producer. B. The Department may grant or deny a permit based on the criteria, as set forth in this chapter. C. To qualify for a permit, an applicant shall: (1) Provide the Department with the plans and specifications set forth in Regulations .14, .15, and .16 of this chapter; (2) Submit an application to the Department on the forms that the Department provides; and (3) Pay the Department’s required permit fee, as specified in COMAR 10.01.17. D. A permit: (1) Expires 1 year from the date of issuance; (2) May be renewed by a producer for a 1-year period upon the payment of the required fee, as specified in COMAR 10.01.17; and (3) May not be transferred from one person to another person or from one farmstead cheese facility to another. E. Subject to the availability of sufficient inspection and testing staff, equipment, and other resources, the Department shall issue a permit entitled Milk Processor—Farmstead Cheese Producer: (1) To an applicant in accordance with Health-General Article, §§21-415 and 21-416.1, Annotated Code of Maryland; and (2) For the purpose of performing the specific process or processes to the specific milk or milk products as indicated on the plan review and permit applications. #### Regulation .06 Sanitation Inspection Frequencies and Reports for Plants. *COMAR 10.15.08.06* A. A farmstead cheese processor shall meet the standards set forth in this chapter. B. The Department shall conduct sanitation inspections of a plant within the Departmental Inspection Area and any other area designated by the Department: (1) At the start-up of farmstead cheese processing; (2) Once every 6 months; and (3) In response to a complaint received by the Department or a local health department. C. Once a year a water supply survey shall be conducted to ensure that the requirements in Regulation .14 and .15 of this chapter are met. D. Reinspections. (1) If an inspection discloses the existence of a critical or repeat violation of a requirement set forth in this chapter, the Department shall reinspect within 30 days to determine compliance with the requirements of this chapter. (2) If the Department finds on the second inspection a violation of the same requirement of this chapter, the Department shall issue a notice of intent to suspend the permit or a compliance schedule. (3) If the Department finds a violation of the same requirement as specified on the notice of intent to suspend the permit or the compliance schedule as specified in the notice, the Department shall: (a) Suspend the permit in accordance with Regulation .20 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland; or (b) Initiate appropriate court action. E. Inspection Reports. (1) The Department shall give one copy of the inspection report to the permit holder or other responsible person or post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection. (2) The permit holder: (a) May not deface the inspection report; and (b) Shall make the inspection report available to the Department upon request. #### Regulation .07 Sanitation Inspection Standards for a Plant. *COMAR 10.15.08.07* A plant shall meet the sanitation inspection standards set forth in this regulation: A. Floor — Construction. (1) The floor of each room in which product containers, utensils, equipment, milk, or cheese products are handled, processed, packaged, stored, or washed shall be: (a) Constructed of concrete or other equally impervious and easily cleanable material; and (b) Smooth, properly sloped, provided with trapped drains, and kept in good repair. (2) Floor drains are not required in cold storage rooms used for storing milk and cheese products when the floor is sloped to drain to one or more exits. (3) A storage room for storing dry ingredients, packaged dry ingredients, and packaging materials may have: (a) Floor drains; and (b) Floors constructed of tightly joined wood. B. Wall and Ceiling — Construction. The wall and ceiling of each room in which milk or cheese products is handled, processed, packaged, or stored shall: (1) Have a smooth, washable, light colored surface; and (2) Be in good repair. C. Door and Window. (1) The plant shall provide effective means to prevent access by insects and rodents. (2) An opening to the outside shall: (a) Have solid doors or glazed windows; and (b) Be closed during weather conditions that may result in particulate matter entering the facility. D. Lighting and Ventilation. Each room shall be well lit and well ventilated where: (1) Milk and cheese products are: (a) Handled; (b) Processed; (c) Packaged; or (d) Stored; or (2) Milk containers, utensils, and equipment are washed. E. Separate Room. (1) There shall be a separate room for: (a) Receiving farmstead cheese; (b) Processing farmstead cheese; (c) Cooling farmstead cheese; (d) Aging farmstead cheese; (e) Packaging farmstead cheese; and (f) Cleaning raw milk cans and containers brought in from the farm. (2) A room may not open directly into a stable or room used for a domestic purpose where: (a) Milk or a farmstead cheese product is: (i) Received; (ii) Handled; (iii) Processed; (iv) Stored; or (v) Packaged; or (b) Containers, utensils, or equipment are washed or stored. (3) A room shall be of sufficient size for their intended purposes. (4) Each designated area or room shall be provided for receiving, handling, and storage of a returned packaged or farmstead cheese not suitable for sale. F. Toilet Sewage Disposal Facility. (1) Each toilet facility shall conform to the regulations of the local health department. (2) Each toilet facility may not open directly into a room where milk or cheese products are processed. (3) Each toilet facility shall be completely enclosed and have a tight fitting, self-closing door. (4) Each dressing room, toilet room, and fixture shall be: (a) Kept in a clean condition; (b) Kept in good repair; (c) Well ventilated; and (d) Well lit. (5) Sewage and other liquid waste shall be disposed of in a sanitary manner. G. Water Supply. Water for plant purposes shall be: (1) From a supply properly located, protected, and operated; (2) Easily accessible; (3) Adequate; and (4) Of a safe, sanitary quality. H. Handwashing Facility. A hand washing facility shall: (1) Provide: (a) Either: (i) Hot and cold running water; or (ii) Warm running water; (b) Soap; and (c) Individual sanitary towels. (2) Be kept in a clean condition and in good repair. I. Plant Cleanliness. (1) A room shall be kept clean, neat, and free of evidence of insects and rodents where: (a) Milk and a farmstead cheese product is: (i) Handled; (ii) Processed; or (iii) Stored; or (b) Containers, utensils, or equipment are washed or stored. (2) Only equipment directly related to processing operations or the handling of containers, utensils, and equipment shall be permitted in a room where: (a) Receiving; (b) Processing; (c) Cooling; (d) Aging; (e) Packaging; (f) Bulk milk is stored; or (g) A cheese product is stored. J. Sanitary Piping. (1) The material of a sanitary piping fitting and connection exposed to milk, cheese products, or liquids drawn into milk and cheese products shall be: (a) Smooth; (b) Impervious; (c) Corrosion resistant; (d) Nontoxic; (e) Easy cleanable; and (f) An approved surface for food product contact. (2) All piping shall be in good repair. K. Construction and Repair of Containers and Equipment. (1) A multiuse container and equipment that milk and a farmstead cheese product comes into contact with shall be: (a) Constructed of smooth, impervious, corrosion resistant, and nontoxic material; (b) Constructed for ease of cleaning; and (c) Maintained in good repair. (2) A single service container, closure, gasket, and other article that milk and a farmstead cheese product come in contact with shall be: (a) Nontoxic; and (b) Manufactured, packaged, transported, and handled in a sanitary manner. (3) Articles intended for single service use may not be reused. L. Clean and Sanitation of Containers and Equipment. (1) The contact surface of a multiuse container, utensil, and equipment used in the farmstead cheese process from receiving through packaging shall, before each use, be effectively cleaned and sanitized. (2) Sanitization: (a) May not adversely affect the equipment, the milk or milk product, or the health of consumers; and (b) Shall be acceptable to the Department. (3) A cloth used for cheese making shall be cleaned and sanitized at intervals, and in accordance with the Department. M. Storage of Cleaned Containers and Equipment. After cleaning, a multiuse milk or farmstead cheese product container, utensil, and equipment shall be: (1) Transported and stored to assure complete drainage; and (2) Protected from contamination before use. N. Storage of Single Service Containers, Utensils, and Materials. A wrap, liner, bag, container, gasket, and other single service article in contact with milk and a farmstead cheese product shall be: (1) Purchased and stored in a sanitary tube, wrapping, or carton; (2) Kept in a clean, dry place until used; and (3) Handled in a sanitary manner. O. Protection from Contamination. (1) The facility, plant operation, and equipment shall be located and used in a manner to prevent contamination of a milk and farmstead cheese product, ingredient, container, utensil, and equipment. (2) A milk or a farmstead cheese product ingredient shall be discarded if: (a) Spilt; (b) Overflowing; (c) Leaking; or (d) Dropped or has fallen onto an unsanitized contact surface or nonproduct contact surface. (3) The processing or handling of a product other than milk or a farmstead cheese product in the plant, shall be performed to preclude the contamination of such milk and farmstead cheese products. (4) The storage, handling, and use of a poisonous or toxic material shall be performed to preclude the contamination of: (a) A milk and a farmstead cheese product; (b) An ingredient of milk and a farmstead cheese product; or (c) The product contact surface of a container, utensil, and equipment. P. Cross Contamination. (1) During processing, a pipeline and equipment used to contain or conduct milk and a farmstead cheese product shall be effectively separated from each tank or circuit containing cleaning or sanitizing solutions. (2) Separation shall be accomplished by: (a) Physically disconnecting a connection point between each tank or circuit containing a cleaning or sanitizing solution from a pipeline and equipment used to contain or conduct a milk or farmstead cheese product; or (b) A method approved by the Department. (3) The farmstead cheese processor shall provide a means to prevent contamination of milk and a farmstead cheese product, container, utensil, and equipment from dripping, spillage, and splash from an overhead piping, platform, or mezzanine. (4) A product that may create a public health hazard may not be handled in the plant. (5) Permission to handle a product other than farmstead cheese or to conduct an operation in equipment or a room, other than those designated, shall be provisional and subject to revocation if found objectionable. Q. Raw Milk Cooling and Farmstead Cheese Processing. (1) Raw milk shall be maintained at 7ºC (45ºF) or less until processed. (2) Farmstead cheese shall meet the definition of a hard cheese as found in 21 CFR 133.150 which states hard cheese: (a) Contains not more than 39 percent of moisture; and (b) Solids contain not less than 50 percent of milk fat, as determined by the methods prescribed in 21 CFR 133.5(a), (b), and (d). (3) Farmstead cheese shall be cured at a temperature of not less than 35°F for not less than 60 days. R. Personnel Sanitation. (1) An individual shall wash their hands thoroughly before commencing a plant function and as often as may be required to remove soil and contamination. (2) An employee may not resume work after visiting the toilet room without thoroughly washing their hands. (3) An individual shall wear clean outer garments while engaged in the: (a) Handling of raw milk and ingredients; (b) Processing of a farmstead cheese product; (c) Storage of a farmstead cheese product; (d) Transportation of a farmstead cheese product; (e) Packaging of a farmstead cheese product; and (f) Handling of a container, utensil, and equipment. (4) An individual, while engaged in the processing of milk or a farmstead cheese product, shall: (a) Wear an adequate hair covering; (b) Abstain from tobacco use; (c) Wear clean and sanitized footwear; (d) Maintain trim and clean fingernails and not wear false fingernails; and (e) Abstain from any activity that may contaminate food. (5) The farmstead cheese processor shall ensure that education and training is provided to an employee in: (a) Food processing and handling; (b) Personal hygiene; and (c) Plant sanitation. S. Vehicles. (1) A vehicle used for the transportation of raw milk and a farmstead cheese product shall be constructed and operated so that the milk and the farmstead cheese product is maintained at 7ºC (45ºF) or less and is protected from contamination. (2) A vehicle used to transport milk and a farmstead cheese product may not be used to transport or contain a substance that may be toxic or harmful to humans. T. Surroundings. Plant surroundings shall be kept neat, clean, and free from conditions which: (1) Attract or harbor flies, other insects, or rodents; or (2) Otherwise constitute a nuisance. #### Regulation .08 Examination and Standards of Raw Milk, Farmstead Cheese Finished Products, and Water Supply. *COMAR 10.15.08.08* A. Raw Milk Sampling and Testing Standards. (1) The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of raw milk used for the manufacture of farmstead cheese; (2) Sampling shall be conducted by an industry plant sampler; (3) The raw milk used for the manufacture of farmstead cheese shall be tested monthly for: (a) Bacteria; (b) Drug residue; (c) Temperature; (d) Odor; and (e) Appearance. B. Raw Milk Quality Standards. (1) A standard plate count of raw milk for farmstead cheese may not exceed 500,000 per milliliter; (2) Raw milk shall meet the following drug residue standards: (a) Raw milk for farmstead cheese shall be negative for drug residue. (b) Before processing, the industry plant sampler shall collect a representative sample of raw milk used in the manufacture of farmstead cheese; and (c) An official laboratory or officially designated laboratory shall conduct drug residue testing for the presence of drug residue in accordance with the Grade “A” Pasteurized Milk Ordinance, Appendix N. (3) Raw milk shall meet the following temperature standards: (a) Raw milk for farmstead cheese shall be cooled to 7°C (45°F) or less within two hours after initial milking; (b) The blend temperature after the first and subsequent milkings may not exceed 10°C (50°F). (c) Raw milk for farmstead cheese shall be cooled to and maintained at a temperature not to exceed 7°C (45°F). (4) The appearance and odor of raw milk used for farmstead cheese shall be free from: (a) Objectionable feed; (b) Off odors; and (c) Abnormalities. (5) In accordance with the Department, an official laboratory or officially designated laboratory shall test a composite milk sample and shall rate it “acceptable for use” if there is no actionable residue for: (a) Radionuclides; (b) Pesticides; and (c) Herbicides. (6) Added water shall be tested on an individual producer’s milk in accordance with the Department’s official laboratory or officially designated laboratory and rated “acceptable for use” if the test result is -0.540°H or less. C. Farmstead Cheese Finished Product Sampling. (1) The farmstead cheese processor is responsible for the collection and cost associated with the sampling and testing of a finished farmstead cheese product; (2) Sampling shall be conducted by an industry plant sampler; (3) The initial three finished products of each farmstead cheese shall be tested for: (a) Salmonella; (b) Escherichia coli (E. coli); (c) Listeria monocytogenes; (d) Staphylococcus aureus; (e) Enterohemorrhagic E. coli (0157:H7); and (f) Percent moisture. (4) The finished product of each farmstead cheese shall be tested annually and is in accordance with §C(3) of this regulation. D. Farmstead Cheese Finished Product Quality Standards. The farmstead cheese finished product: (1) Shall test negative for Salmonella, Enterohemorrhagic E. coli (0157:H7), and Listeria monocytogenes; (2) Shall test less than 10 cfu/gram for E. coli and Staphylococcus aureus; and (3) May not be greater than 39 percent moisture. E. Farmstead Cheese Processing Standards. The farmstead cheese: (1) Finished product shall be aged at least 60 calendar days before offering for sale; (2) Shall be aged or cured at a temperature of not less than 35°F; and (3) Finished product may not contain more than 39 percent moisture at the end of the aging period. F. The farmstead cheese processor shall ensure that the result of all tested farmstead cheese finished products are submitted and approved by the Department before further processing or sale of the farmstead cheese. G. The Department may request that the farmstead cheese processor have the farmstead cheese finished product tested, as needed, as set forth in the United States Food and Drug Administration Food Compliance Program, “Domestic and Imported Cheese and Cheese Products,” to ensure compliance with this regulation. H. Water Samples. (1) Samples for bacteriological testing of the plant water supply and, if applicable, any other water used for cooling and processing shall be collected: (a) Upon the initial approval of the physical structure; (b) Every 6 months thereafter; and (c) When any repair or alteration to the water supply system has been made. (2) Plant water for testing shall be obtained from a potable water supply system that complies with Regulation .15A of this chapter. (3) Samples shall be taken by the Department and examined by an official laboratory. I. Record Keeping Required. (1) Current written step by step standard operating procedures are required for: (a) Product trace back; (b) Product recalls; (c) Drug residue testing; (d) Cleaning of the equipment and facility; (e) Sanitizing equipment and product contact surfaces; (f) Receiving, processing, aging, storage, and packaging of each type of farmstead cheese produced; (g) Pest control and preventative maintenance; and (h) Employee training including personal hygiene practices; (2) Processing records shall include the: (a) Product being manufactured; (b) Drug residue testing as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix N; (c) Date and result of the raw milk testing; (d) Date and result of the finished farmstead cheese product tested; (e) The pH of each batch after inoculation at 5 hours, 24 hours, and the end of aging; and (f) Raw ingredient: (i) Origin; (ii) Storage; (iii) Transportation; and (iv) Other information required by the Department; and (g) Temperature, as set forth in Regulation .07 of this chapter. (3) For each batch of farmstead cheese produced, a make record shall be maintained and include: (a) The name of the product being produced; (b) The temperature of the milk being used; (c) A unique identifier assigned at the start of the production of that batch of cheese shall be: (i) Used to track each batch of cheese through the production process; and (ii) Included on the product label; (d) The amount of product being produced; (e) The name and amount of each ingredient added; (f) The cook temperature; (g) The pH of the product after inoculation at 5 hours, 24 hours, and the end of aging; and (h) The production date for the product which is the date the batch entered the aging room to start the aging process; and (4) Each record shall be available to the Department for review during each inspection. #### Regulation .09 Enforcement Actions. *COMAR 10.15.08.09* A. Raw Milk Enforcement. (1) When two of the last four consecutive bacterial count or cooling temperatures, taken on separate days, exceed the limit for raw milk, as set forth in this chapter, the Department shall: (a) Send to the permit holder a written notice of intent to suspend the permit which shall remain in effect as long as two of the last four consecutive samples exceed the limit of the standard; and (b) Take an additional sample within 21 days of the written notice of intent to suspend, but not before 3 days have elapsed. (2) When the standard set forth in Regulation .08 of this chapter is violated three of the last five consecutive bacterial counts or cooling temperature tests the Department shall immediately suspend the permit in accordance with this section, Regulation .20 of this chapter, and Health-General Article, §21-418, Annotated Code of Maryland. (3) The Department shall conduct an investigation and take enforcement action in accordance with the Grade “A” Pasteurized Milk Ordinance, Appendix N, when a drug test is positive. (4) When an odor and appearance evaluation results in rejection of milk: (a) The Department shall conduct an investigation to determine the reason for the rejection; and (b) A person may not offer the rejected milk for sale. (5) When a pesticide, herbicide, or radionuclide residue test is positive: (a) The Department shall conduct an investigation to determine the cause and the cause shall be corrected; (b) An additional sample shall be taken and tested for the pesticide, herbicide, or radionuclide, and no milk shall be used for processing or offered for sale until it is shown by a subsequent sample to be free of the positive residue; and (c) The Department may suspend a permit based on the presence of pesticide, herbicide, or radionuclide residue. B. Farmstead Cheese Finished Product Enforcement. (1) When the pathogen testing result exceeds the limits set forth in Regulation .08 of this chapter, the cheese in violation may not be offered for sale, and the: (a) Department shall conduct an investigation to determine the cause; and (b) Cause shall be corrected prior to resumption of processing. (2) A person may not offer for sale a farmstead cheese product if the processing requirement is in violation of this chapter at the end of the aging period: (a) Days of aging; (b) Temperature during aging; or (c) Percent moisture. (3) Cheese may be detained and further pathogen testing may be required to show compliance. C. Reinstatement of Permits. (1) To reinstate a permit that is suspended for either a bacteria count or cooling violation the permit holder shall: (a) Submit a written application for the reinstatement of the permit; (b) Successfully complete a Department inspection of the facility within 1 week of a reinstatement request to ensure that the condition responsible for the violation is corrected; (c) Accept a temporary permit if it has determined that the facility is in compliance; and (d) Complete an accelerated sampling program at the rate of no more than two samples per week on separate days within a 3-week period to confirm that the violation has been corrected. (2) The Department shall fully reinstate the permit upon compliance with the appropriate bacteria and temperature standard as determined in accordance with Regulation .08 of this chapter. (3) To reinstate a suspended permit for violations other than bacteriological, drug residue test, or cooling temperature standards, the permit holder shall: (a) Notify the Department that the violation has been corrected; and (b) Successfully complete a Department inspection of the facility within 1 week of a reinstatement request to ensure that the condition responsible for the violation is corrected. (4) When a permit suspension has been due to a positive drug residue, the permit shall be reinstated in accordance with the provisions of the Grade “A” Pasteurized Milk Ordinance, Appendix N, incorporated by reference in Regulation .03 of this chapter. #### Regulation .10 Improper Handling of Milk Products. *COMAR 10.15.08.10* A. Pursuant to Health-General Article, §21-428, Annotated Code of Maryland, the Department shall impound milk or a milk product intended for human consumption due to improper handling. B. The Department may: (1) Issue an order to make the milk or milk product unusable for consumption before disposing of the milk or milk product; and (2) Impose a civil monetary penalty, as set forth in §C of this regulation. C. The Department shall determine the amount of the civil monetary penalty by multiplying the volume of the milk listed on the shipping documents by the current milk price of the applicable market, as set by the Federal Milk Market Administrator on the date of the impounding. D. A person subject to an impoundment order may seek legal recourse, as set forth in Health-General Article §21-428, Annotated Code of Maryland, by: (1) Appealing a civil penalty; or (2) Bringing an action for damages. #### Regulation .11 Labeling of Farmstead Cheese. *COMAR 10.15.08.11* A farmstead cheese processor shall: A. Ensure all labels for a farmstead cheese product conform to the standards and requirements established by: (1) The Federal Food, Drug, and Cosmetic Act, 21 USC, §§341—350f; (2) The Nutrition Labeling and Education Act of 1990 (Public Law 101-535); (3) 21 CFR Parts 101 and 133; and (4) Health-General Article, §21-424, Annotated Code of Maryland; and B. Conspicuously mark each package containing farmstead cheese with the: (1) Name of the product; (2) Name of the manufacturer that made the farmstead cheese; (3) Address of the manufacturer if: (a) Listed in the local phone book, the address may consist of the city and state; or (b) Not listed in the local phone book, the street address shall be included; (4) Plant license number; (5) Each ingredient in order of predominance; (6) Net weight of the product in English and metric units; (7) Batch identification of the product; (8) Required nutritional information; (9) Statement: (a) “Cured or aged for 60 days at a temperature not less than 35° F;” or (b) A variation of this phrase that conveys the fact that the product has been aged at least 60 days; and (10) Statement that the milk was not pasteurized, using terms such as “raw milk” or “not pasteurized.” #### Regulation .12 Sale of Raw Milk. *COMAR 10.15.08.12* Pursuant to Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell raw milk for human consumption. #### Regulation .13 Animal Health. *COMAR 10.15.08.13* All raw milk for farmstead cheese shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8, incorporated by reference in Regulation .03 of this chapter. #### Regulation .14 Plant Construction and Plan Submission. *COMAR 10.15.08.14* Pursuant to Health-General Article, §§21-410, 21-411, and 21-413 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department: A. A plan and specification before: (1) A plant is constructed, reconstructed, or extensively altered; (2) An existing building or structure is converted or remodeled for use as a plant; (3) A plant process is added, replaced, relocated, or modified; or (4) A clean-in-place (CIP), other washing system, or part of a CIP is added, modified, or replaced; B. A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work; C. Contact information for the facility, including: (1) The full name, title, and telephone number of each applicant; (2) The name of the plant; (3) The mailing address; (4) The location; and (5) Directions to the site; D. A narrative describing the scope and purpose of the project, including a projected timeline from start to completion; E. An estimate of the finished product output per day; F. A sample product label for each product; G. A list of the: (1) Type of raw milk cheese to be processed and sold; (2) Each raw ingredient and the ingredient source; and (3) Single service container source; H. A scale drawing showing the layout and arrangement of an area within and around the plant, including the: (1) Processing area; (2) Chemical storage; (3) Dry storage; (4) Ingredient and product storage; (5) Receiving area; (6) Load out area; (7) Laboratory space; (8) Office; (9) Restroom facility; (10) Locker or similar storage facility for the storage of personal items; and (11) Separate area for employees to eat and drink beverages; I. A scale drawing showing the location of all equipment, including the: (1) Milk processing equipment; (2) Milk tank and silo; (3) CIP system; (4) Glycol water tank; (5) Recirculating cooling water tank; (6) Boiler; and (7) Boiler makeup tank; J. A scale drawing showing the location of plumbing and each plumbing fixture, including the: (1) Water line; (2) Sewer line; (3) Hand sink; (4) Toilet; (5) Utility sink; (6) Utensil washing sink; (7) Floor drain; (8) Floor sink; (9) Hose station; and (10) Back flow prevention device; K. A legend for each drawing; L. Specifications for: (1) Ventilation, including, but not limited to, the type and location of: (a) An air filter; (b) An air pump; and (c) A compressor; and (2) Construction material for the building and interior finish; M. A list and description of boiler, glycol, and recirculating water additive and water treatment; N. A description of the: (1) Type of disposal for wastewater and sewage; (2) Source and system for the facility’s potable water supply; (3) Lighting fixture and placement; and (4) Recirculating cooling system; O. Each specification sheet, including manufacturer and model number of the plant equipment; P. A document that lists the flow for a products through the plant identifying each functional piece of equipment and each process used in processing and packaging; Q. A CIP flow diagram from the makeup tanks through all equipment; R. Information and drawings on how separation from product lines will be accomplished, if applicable; S. Written step by step standard operating procedures for: (1) Receiving, processing, aging, storing, and packaging of each type of farmstead cheese product; (2) Drug residue testing; (3) Cleaning and sanitization for all equipment; (4) Cleaning and sanitization for the facility; (5) Product trace back, inclusive of production/make sheet; and (6) Product recall; T. Pest and mite control program; U. A specification and standard operating procedure for how wood shelving used in the aging of cheese will be: (1) Designed; (2) Installed; (3) Used; (4) Cleaned; (5) Sanitized; (6) Maintained; and (7) Inspected by the farmstead cheese processor; and V. Employee training and personal hygiene practices. #### Regulation .15 Physical Plant Requirements for Plants. *COMAR 10.15.08.15* A. Water used at a farmstead cheese facility shall: (1) Be obtained from a potable water supply system that complies with: (a) Environment Article, Title 9, Annotated Code of Maryland; (b) COMAR 26.04.04; and (c) The Grade “A” Pasteurized Milk Ordinance, Appendix D, incorporated by reference in Regulation .03 of this chapter; (2) Be installed in a manner that prevents backflow or back siphoning; (3) Be separate from a nonpotable water supply system so that nonpotable water can be drawn or discharged into the potable water supply system; (4) Provide hot and cold running water in an area where milk processing equipment is washed; and (5) Have sufficient water capacity, pressure, and hot water generation and distribution to meet peak demands throughout the washing system; B. Hand sinks shall have: (1) Either: (a) Hot and cold running water; or (b) Warm running water; (2) A supply of hand cleaning soap or detergent; and (3) A sanitary means of drying hands, such as individual towels or a hand drying device; C. A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations; D. Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and E. Electrical systems at the facility shall: (1) Comply with State and local electrical laws, ordinances, and regulations; (2) Provide adequate lighting sources that furnish at least 30 foot candles of light in all working areas and rooms where: (a) Milk or a milk product is handled, processed, packaged, or stored; or (b) A container, utensil, and equipment are washed; and (3) Provide adequate lighting sources that furnish at least five foot candles of light in dry storage and cold storage rooms. #### Regulation .16 Plan Review and Approval Process. *COMAR 10.15.08.16* A. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department. B. An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in Regulations .14 and .15 of this chapter. C. The Department shall: (1) Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .14 and .15 of this chapter; and (2) Inform the applicant: (a) That the plan has been received; (b) If additional information is required to complete the plan review; (c) Whether the plan is approved or denied; and (d) Of the appeal process, if the plan is denied. #### Regulation .17 Personnel Health. *COMAR 10.15.08.17* No individual affected with any disease capable of being transmitted to others through the contamination of food shall work at a plant in any capacity which brings them into direct contact with: A. Raw milk, a farmstead cheese product, and a food ingredient; or B. Associated raw milk and a food product contact surface. #### Regulation .18 Procedure When Infection or High Risk of Infection is Suspected or Discovered. *COMAR 10.15.08.18* In accordance with Health-General Article, §§18-102, 21-253, 21-254, and 21-435, Annotated Code of Maryland, when an individual working at a plant has a communicable disease or is a carrier of a communicable disease the Department: A. Shall immediately exclude the: (1) Individual from handling milk, milk products, milk containers, and milk equipment; and (2) Milk supply that is handled by the infected individual from distribution and use; and B. May require medical and biological examination of the individual and the individual’s bodily discharges. #### Regulation .19 Confidentiality. *COMAR 10.15.08.19* The Department shall maintain confidentiality of records submitted by a person in accordance with §4-335 of the General Provisions Article, Annotated Code of Maryland. #### Regulation .20 Suspension and Revocation of Permits. *COMAR 10.15.08.20* A. When a farmstead cheese processor is found in violation of this chapter, the Department may suspend or revoke a permit as set forth in this regulation and Health-General Article, §§21-211, 21-418, or 21-419, Annotated Code of Maryland. B. Except as otherwise provided in this regulation, before suspending a permit, the Department shall give to the farmstead cheese processor notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland. C. The Department may suspend a permit if the farmstead cheese processor fails or neglects to correct a violation within the specified time period. D. If a permit has been suspended more than once, the Department may revoke the permit. E. When an immediate and substantial danger is found to exist to public health, safety, or welfare that requires emergency action, pursuant to Health-General Article, §21-418(c) and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the: (1) Department shall: (a) Summarily suspend the permit; (b) Order the farmstead cheese processor to cease operation immediately; and (c) Promptly provide the farmstead cheese processor with: (i) A written notice of the suspension of the permit; (ii) The reasons for the suspension; and (iii) An opportunity to be heard; and (2) The farmstead cheese processor shall immediately cease operation upon the receipt of the summary suspension order. #### Regulation .21 Appeals Process. *COMAR 10.15.08.21* In accordance with the Administrative Procedures Act and Health-General Article, §21-419 the Department shall ensure that an opportunity for a hearing is provided to a farmstead cheese processor whose plan review or permit has been: A. Denied; B. Suspended; or C. Revoked. ### Chapter 09 — Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk **Authority:** Health-General Article, §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-405, 21-406, 21-428, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Regulations .01—.20 repealed and new Regulations .01—.22 adopted effective May 20, 2019 (46:10 Md. R. 488) #### Regulation .01 Scope. *COMAR 10.15.09.01* A. In accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, this chapter: (1) Governs permits for the sale of milk for manufacturing processes; (2) Describes the requirement for a permit for the sale of milk for manufacturing purposes; and (3) Regulates the inspection of manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products. B. This chapter also sets forth: (1) Standards for milk manufacturing; (2) The plan review process for manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products; (3) The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of manufactured grade milk and milk products; (4) Penalties pursuant to Health-General Article, §§21-211, 21-252—21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and (5) Requirements for dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products. #### Regulation .02 Definitions. *COMAR 10.15.09.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “3-A Sanitary Standards” means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the: (a) American Dairy Products Institute; (b) International Dairy Foods Association; (c) Food Processing Suppliers Association; and (d) International Association for Food Protection. (2) “Agistment agreement” means the sale of shares or interest in a: (a) Cow, goat, or other lactating hooved mammal; or (b) Herd of cows, goats, or other lactating hooved mammals. (3) “Approved” means meeting the criteria set forth in this chapter. (4) “Aseptic processing and packaging” means the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms. (5) “Bobtailer” means a person who operates or controls a manufactured milk product route and distributes a manufactured milk product that the person buys from a distributer or manufactured milk processor. (6) “Bulk milk hauler/sampler” means an individual who: (a) Collects official samples; (b) Transports raw milk from a farm, or raw milk products to or from a: (i) Milk plant; (ii) Receiving station; or (iii) Transfer station; (c) Possesses a permit from any state to sample milk or raw milk products; and (d) If they are sampling raw milk in the State, possesses a Maryland Bulk Milk Hauler license. (7) “Butter” means the food product that is made exclusively from milk or cream, or both, with or without salt, and with or without additional coloring matter, and that contains not less than 80 percent by weight of milk fat. (8) “Certified industry dairy farm inspector” means a person who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to perform as specified in that section. (9) “Cheese” means the fresh or matured product that: (a) Is obtained by draining after coagulation of milk, cream, skimmed or partly skimmed milk, or a combination of some or all of these products; and (b) Meets the standards of identity in 21 CFR Part 133. (10) “Commercial sterility” means the condition achieved by a treatment that renders equipment, containers, and food free of viable microorganisms that are capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution. (11) “Dairy farm” means a place where at least one cow, goat, or other hooved mammal is kept, and from which the milk from these animals is sold or offered for sale. (12) “Dairy plant sampler” mean a person responsible for the collection of official samples for regulatory purposes outlined in Section 6 of the Pasteurized Milk Ordinance. (13) “Department” means the Maryland Department of Health or its designee. (14) “Departmental inspection area” means the area in which the Department routinely makes inspections, which consists of that area within the boundaries of Maryland and any other area as may be designated by the Secretary. (15) “Distribution station” means a place or vehicle where, for redistribution and resale, a manufactured grade milk product routinely is received, stored, or transferred. (16) “Distributor” means a person who offers for sale a manufactured grade milk product. (17) “Heat treated cream” means milk that has been heated during separation to temperatures greater than 52ºC (125ºF) but less than 75ºC (166ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping cream for bulk shipments. (18) “Heat treated milk” means milk that has been heated one time during separation to temperatures greater than 52ºC (125ºF) but less than 72ºC (161ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping heat treated nonfat skim milk, reduced fat milk, or lowfat milk for bulk shipments. (19) “Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station. (20) “Instant nonfat dry milk” means nonfat dry milk that has been produced in such a manner as to substantially improve its dispersing and reconstitution characteristics over that produced by the conventional processes. (21) “Manufactured grade milk” means the milk of a cow, goat, or other hooved mammal that is produced, processed, pasteurized, packaged, or prepared for human consumption in accordance with the standards set forth in this chapter. (22) “Manufactured grade milk product” means: (a) Butter; (b) Cheese, natural or processed; (c) Condensed skim milk, plain or sweetened; (d) Condensed whole milk; (e) Cream; (f) Dry buttermilk; (g) Dry whey; (h) Dry whole milk; (i) Evaporated milk, whole or skim; (j) Nonfat dry milk; (k) Quark; or (l) Any other product made with manufactured grade milk that is regulated by the Department. (23) “Milk” means the lacteal secretion of a cow, goat, or other hooved mammal, practically free from colostrum, obtained by the complete milking of one or more healthy hooved mammals. (24) “Milk facility” means a: (a) Distribution station; (b) Milk plant; (c) Milk processor; (d) Milk tank truck cleaning facility; (e) Receiving station; or (f) Transfer station. (25) “Milk hauler” means an individual who is in charge of a milk tank truck while it is receiving, transporting, or delivering milk or a milk product. (26) “Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk. (27) Milk Plant. (a) “Milk plant” means a place where milk products are: (i) Received and stored; (ii) Processed; (iii) Pasteurized; (iv) Packaged; or (v) Prepared for distribution. (b) “Milk plant” does not include a place where milk products are sold at retail only. (28) “Milk processor” means a person who owns, operates, or controls a milk plant. (29) “Milk producer” means a person who: (a) Operates a dairy farm; and (b) Provides, sells, or offers milk for sale to a: (i) Milk plant; (ii) Receiving station; or (iii) Transfer station. (30) “Milk product” means butter, cream, natural or processed cheese, dry milk or whey product, whole or skim evaporated milk, condensed whole milk, and plain or sweetened condensed skim milk, all of which are defined or described in this chapter, or at 21 CFR 131, 133, and 184, and any other product that may be developed and made from manufactured grade milk. (31) “Milk tank truck” means a truck and its equipment that are used to transport milk or milk products. (32) “Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized. (33) “Milk tank truck driver” means an individual who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station, or transfer station and does not sample producer raw milk. (34) “Milk transport container” means a vessel meeting 3-A Sanitary Standards or equivalent standards used by on-farm processors to transport milk from the dairy farm to the milk plant. (35) “National Conference on Interstate Milk Shipments (NCIMS)” means a nonprofit organization made up of persons involved in the dairy industry, who make the laws governing all aspects of the milk sanitation program. (36) Nonfat. (a) “Nonfat” means a product contains less than 0.5 percent fat. (b) “Nonfat” has the same meaning as skim or fat free. (37) “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department. (38) “Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of: (a) Producer samples of Grade “A” raw milk for pasteurization; or (b) Comingled milk tank truck samples of Grade “A” raw milk. (39) “On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer. (40) “Pasteurization” means the process of heating every particle of milk or milk product, in approved and properly designed equipment, by: (a) Heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time: (i) 63°C (145°F) for 30 minutes; (ii) 72°C (161°F) for 15 seconds; (iii) 89°C (191°F) for 1 second; (iv) 90°C (194°F) for 0.5 seconds; (v) 94°C (201°F) for 0.1 seconds; (vi) 96°C (204°F) for 0.05 seconds; or (vii) 100°C (212°F) for 0.01 seconds; (b) For milk or milk products with fat content of 10 percent or greater, a total solids of 18 percent or greater, or containing added sweeteners, heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time: (i) 66°C (150°F) for 30 minutes; (ii) 75°C (166°F) for 15 seconds; or (iii) The temperatures and times listed in §B(34)(a)(iii)—(vii) of this regulation; (c) For milk or milk products that the USDA requires a specific product pasteurization temperature for, heating the product to the temperature requirement outlined in the USDA Milk for Manufacturing Purposes and its Production and Processing, Recommend Requirements; or (d) Utilizing another process found equivalent to pasteurization for milk and milk products, which has been recognized and approved by FDA as provided in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §343(h)(3). (41) “Permit” means an official document with a manufactured grade classification issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit. (42) “Permittee” means a person who holds a permit as defined in this chapter. (43) Person. (a) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity. (b) “Person” includes: (i) An operator of a facility that is owned by a State or local unit of government; or (ii) A State or local unit of government if the State or local unit of government is the operator of the facility. (44) “Raw milk” means unpasteurized milk, which includes: (a) Heat treated nonfat skim milk; (b) Heat treated reduced fat milk; (c) Heat treated lowfat milk; and (d) Heat treated cream. (45) “Receiving station” means a place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting. (46) “Recombined” means that a milk or a milk product is made by combining water and nonfat dry milk solids with: (a) Cream; (b) Butterfat; or (c) Milk fat. (47) “Reconstituted” means that a milk or a milk product has resulted from either: (a) Combining dry whole milk solids with the appropriate amount of water; or (b) Adding water to evaporated milk. (48) “Retort processed after packaging” means that the milk or milk product, or both, have been subjected to sufficient heat processing after being packaged in a hermetically sealed container, to: (a) Conform with applicable requirements under 21 CFR Parts 108, 113, and 117; and (b) Maintain commercial sterility of the milk or milk products under nonrefrigerated conditions. (49) “Sale” means a transaction that involves the: (a) Transfer, dispensing, or serving of milk and milk products with or without charge; or (b) Right to acquire milk and milk products: (i) Through barter or contractual arrangement; or (ii) In exchange for another form of compensation including, but not limited to, an agistment agreement. (50) “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms that does not damage the surface or adversely affect the milk or milk product that may come into contact with the surface. (51) “Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year. (52) “Secretary” means the Secretary of Health or the Secretary’s designee. (53) “Sell” means to offer for sale. (54) Skim. (a) “Skim” means a product contains less than 0.5 percent fat. (b) “Skim” has the same meaning as nonfat or fat free. (55) “Transfer station” means a place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another. (56) “Whey” means the liquid substance obtained by separating the coagulum from milk, cream, or nonfat milk in cheese making that meets the requirements of 21 CFR §184.1979. #### Regulation .03 Incorporation by Reference. *COMAR 10.15.09.03* In this chapter the following documents are incorporated by reference: A. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f, as amended; B. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended; C. Bulk Milk Hauler/Sampler Manual, 2016 (Center for Milk & Dairy Product Safety, Office of Food Protection, Maryland Department of Health), which has been incorporated by reference in COMAR 10.15.06.03; D. Maryland Laboratory Evaluation Program Manual, 2017 (Center for Milk and Dairy Product Safety, Office of Food Protection, Maryland Department of Health); E. 21 CFR Parts 100—101, as amended; F. 21 CFR Part 117; G. 21 CFR Parts 130—133, as amended; H. 21 CFR Parts 170—189, as amended; I. FDA Food Safety Modernization Act, 21 U.S.C WITHOUT ADULT SUPERVISION.”; and (9) House rules are posted at the entrance to a pool or spa. #### Regulation .41 Pool and Spa Operator Certification. *COMAR 10.17.01.41* A. A person may not act as or perform the duties of a public pool or spa operator without a pool and spa operator certification card issued by the Secretary as required in §§B and G of this regulation. B. The Secretary shall issue a 3-year public pool and spa operator certification card only to an individual 16 years old or older who has: (1) Completed a 14-hour approved public pool and spa operator's course or a course offered by the Secretary with a minimum grade of 70 percent on an approved written examination given following the completion of that course; or (2) Presented proof of previous certification and has: (a) Completed an approved 4-hour refresher course; or (b) Passed a challenge exam offered by the Secretary. C. The Secretary may summarily suspend a pool and spa operator's certification if the operator does not comply with Regulation .43 of this chapter. D. Hearing for Summary Suspension. In the case of the summary suspension of certification pursuant to §C of this regulation, the Secretary shall provide the certification card holder with written notice of the suspension and an opportunity for a hearing pursuant to State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. E. To preserve the right to a hearing, the certification card holder shall contact the Secretary within 30 days of the receipt of the notice of the suspension. F. The Secretary shall recognize a pool and spa operator certification as valid throughout the State. G. The Secretary shall issue a 3-year limited public-use pool operator certification card to an individual 16 years old or older who has completed: (1) An approved 4-hour limited public-use pool operator's course and passed an approved written examination with a minimum grade of 75 percent following completion of the course; or (2) The requirements of §B of this regulation. H. An individual who possesses a public pool and spa operator certification card may perform the duties of a public pool and spa operator at a limited public-use, recreational, and semipublic pool and public spa. An individual who possesses a limited public-use pool operator certification card may perform the duties of a limited public-use pool operator only at a limited public-use pool. #### Regulation .42 Approval of Operator's Course. *COMAR 10.17.01.42* The Secretary shall approve a pool and a spa operator's course based on the following criteria: A. An approved course shall cover general aspects of public pool and spa operation including: (1) Applicable regulations; (2) Disease prevention; (3) Disinfection; (4) Filtration; (5) Circulation system components; (6) General pool and spa equipment; (7) Operation and maintenance of equipment; (8) Water chemistry; (9) Water testing; (10) Record keeping; (11) General pool and spa chemicals; (12) Chemical handling; (13) Waste water disposal; (14) Safety; (15) Sanitation; and (16) Other pertinent topics as specified by the Secretary; and B. An approved course shall be taught by an individual who has demonstrated to the Secretary: (1) Expertise in the operational aspects listed in §A of this regulation, as evidenced by combined work experience, training, and formal education; and (2) Successful completion of an approved public pool and spa operator's course. #### Regulation .43 Pool and Spa Operation. *COMAR 10.17.01.43* An owner shall ensure that a certified pool and spa operator: A. Is on-site at all times when a recreational pool is open; B. Is available at a semipublic pool, public spa, and at a limited public-use pool for performance of all requirements of this chapter and is able to respond to operational problems within: (1) 30 minutes when not available on-site; or (2) If a contractual certified pool and spa operator, 2 hours when not available on-site; C. Measures and records, or supervises and verifies the measurement and recording of, all information required in Regulation .46 of this chapter; D. Performs all duties related to the operation of a pool or spa as required in this chapter; E. Cleans the filtration system when the filter pressure differential reaches a level specified by the equipment's manufacturer or as specified below: (1) High rate sand filters at 15 psi; (2) Rapid rate sand filters at 8 psi; (3) Cartridge filters at 10 psi; (4) Pressure diatomaceous earth filters at 10 psi; and (5) Vacuum diatomaceous earth filters at 15 inches of mercury; F. Maintains disinfection residuals according to Regulation .44 of this chapter; G. Maintains water chemistry according to Regulation .45 of this chapter; and H. Adds a nonstabilized oxidizer into the pool or spa water equivalent to an amount of free chlorine equal to at least 10 times the measured combined chlorine residual plus sufficient free chlorine to oxidize the ammonia and nitrogenous compounds in the water, on a recommended schedule of once per week for a pool and once per day for a wading pool and for a spa. #### Regulation .44 Disinfection of a Pool and Spa. *COMAR 10.17.01.44* A. An owner or operator of a public pool or spa shall ensure that a disinfectant or combination of disinfectants is added to the water automatically through an approved chemical feeder to maintain continuously a residual level as specified below: (1) Free chlorine shall be between: (a) 1.5 ppm and 10.0 ppm in pools for swimming and diving and water recreational attractions; (b) 3.0 ppm and 10.0 ppm in pools for wading or therapy; and (c) 4.0 ppm and 10.0 ppm in spas; (2) The maximum amount of combined chlorine shall be 0.2 ppm for all pools and spas; (3) Total bromine shall be between: (a) 3.0 ppm and 8.0 ppm in pools for swimming and diving and water recreational attractions; and (b) 4.0 ppm and 8.0 ppm in spas and in pools for wading or therapy; (4) For pools and spas using copper and silver ions as a secondary disinfectant in conjunction with chlorine or bromine as a primary disinfectant: (a) Copper ions shall be between 0.2 ppm and 1.0 ppm; (b) Silver ions may not exceed 0.05 ppm; (c) Free chlorine in combination with copper and silver ions shall be between: (i) 0.5 ppm and 10 ppm in pools for swimming and diving and water recreational attractions; and (ii) 1.5 ppm and 10.0 ppm in spas and in a pool for wading or therapy; and (d) Total bromine in combination with copper and silver ions shall be between: (i) 1.0 ppm and 8.0 ppm in pools for swimming and diving and water recreational attractions; and (ii) 3.0 ppm and 8.0 ppm in spas and pools for wading or therapy; (5) For pools and spas using an ozone generator, the maximum amount of ozone measured 2 inches above the water surface shall be 0.1 ppm; (6) For pools using PHMB, the minimum level of PHMB shall be 30 ppm; and (7) For pools and spas using an ultraviolet light/hydrogen peroxide system, the minimum level of hydrogen peroxide shall be 20 ppm. B. An owner or operator shall ensure that for public pools and spas using cyanuric acid or a similar chlorine stabilizer, the cyanuric acid is maintained between 30 ppm and 100 ppm. C. An owner or operator of a public pool or spa may not use: (1) PHMB in a pool or spa that uses jets or sprays; (2) PHMB in conjunction with any halogen compound or ozone; (3) Cyanuric acid in conjunction with a bromine compound or in an indoor pool or spa; or (4) An ultraviolet light/hydrogen peroxide system in conjunction with a diatomaceous earth filter. #### Regulation .45 Water Chemistry of a Pool and Spa. *COMAR 10.17.01.45* A. An owner or operator shall ensure that the water chemistry of a public pool or spa is maintained according to the following requirements: (1) The pH of the water is maintained between 7.2 and 7.8; (2) The total alkalinity of the water is maintained between 60 ppm and 180 ppm; (3) The calcium hardness of the water is maintained between 150 and 400 ppm; (4) The Langelier Saturation Index of the water is maintained between -0.5 and +0.5 as calculated by: (a) The Langelier Saturation Index formula: Langelier Saturation Index = pH + TF + CF + AF - 12.1 where: TF = temperature factor, CF = calcium hardness factor, and AF = alkalinity factor, and (b) The following factor table: (5) The amount of total dissolved solids is maintained so that it does not exceed 1,500 ppm, except for a salt water pool where the total dissolved solids may not exceed 3,000 ppm; (6) The amount of dissolved metals is maintained so that it does not exceed the following levels: (a) Iron, 0.3 ppm, (b) Manganese, 0.3 ppm, and (c) Copper, 1.3 ppm; and (7) The water clarity is maintained so that either a 6 inch seechi disc placed in the deepest part of a pool or spa or the main drain is clearly visible and sharply defined when observed from the side of the pool or spa. B. An owner or operator shall ensure that: (1) Water additives and treatment chemicals are used according to manufacturers' instructions; and (2) When chemicals are added directly to a pool or spa, no one is allowed in the water until the chemicals are dissolved and diffused throughout the pool or spa. C. An owner or operator shall ensure that the water temperature for a heated public pool or spa does not exceed: (1) 88°F for a pool; (2) 104°F for a spa; and (3) 96°F for a therapy pool. #### Regulation .46 Operating Records Required. *COMAR 10.17.01.46* An operator shall maintain operating records on a form provided by the Secretary or an equivalent form and shall: A. Except as provided in §B of this regulation, record the information required in §C(1)—(3) of this regulation in 2-hour intervals for a recreational pool and for a public spa, and three times per day for a limited public-use and semipublic pool and record the information required in §C(4)—(9) of this regulation a minimum of three times per day for a public pool and spa, beginning 1/2 hour before opening; B. For a public pool or spa where an approved automatic controller is used, record the information required in §C of this regulation: (1) A minimum of three times per day in conformance with the following schedule: (a) The first recording of the day shall be made 1/2 hour before the pool or spa opens; (b) The second recording shall be completed between 12 p.m. and 2 p.m.; and (c) The final recording shall be completed 2 hours before closing; and (2) More frequently if required by the Secretary due to conditions such as high bather load, high temperatures, bright sunlight, or inadequate water quality; C. Record the following information in the intervals required in §§A and B of this regulation: (1) Disinfectant residual; (2) Combined chlorine level, if chlorine is used; (3) pH; (4) Water clarity; (5) Water temperature, if heated; (6) Flow rate; (7) Filter influent pressure and effluent pressure; (8) Pump vacuum; and (9) Total number of bathers; D. Record in 1-week intervals for a public pool and in 1-day intervals for a public spa: (1) Total alkalinity level; (2) Calcium hardness level; and (3) Cyanuric acid level, if used; E. Record daily for a public pool or spa: (1) The time of filter backwash or cleaning; (2) An injury or accident at the pool or spa; (3) Chemicals added to the water; and (4) Malfunctioning or broken equipment; F. Date and sign each record sheet; G. Record the results of the following inspections in the specified intervals to complete a Pool and Spa Entrapment Hazards Checklist: (1) Daily check before the facility is open to verify that: (a) Drain covers, vacuum fitting covers, skimmer equalizer covers, and any other suction outlet covers are in place, secure, and unbroken; (b) Skimmer baskets, weirs, lids, flow adjusters, and suction outlet lines are free of any blockage; (c) Inlet and return covers or fittings are in place, secure, and unbroken; (d) Safety warning signs are in place around the pool or spa, including emergency instructions and phone numbers; and (e) On/off switches for pumps are clearly labeled and the location of the pumps is clearly identified; and (2) Check all information required in §G(1) of this regulation before filling a pool or spa with water, after periodic maintenance, and after pool or filter cleaning procedures; H. Keep the records on the premises for a minimum of 3 years; and I. Submit the records to the Secretary upon request. #### Regulation .47 Test Kits. *COMAR 10.17.01.47* A. In order to comply with the requirements of Regulation .46 of this chapter, an owner shall ensure that: (1) One or more of the following for measuring the disinfectant level is used: (a) A chlorine or bromine test kit that is the DPD (diethyl-p-phenylene diamine) reagent system for measuring free and combined chlorine or total bromine with an indicator range from 0.0 to 10.0 ppm or with procedures for performing a dilution test to achieve readings up to 10.0 ppm; (b) An ozone test kit that is the indigo trisulfonate method for measuring ozone with an indicator range from 0.0 to 1.0 ppm; (c) A copper test kit that is accurate to within +/- 0.1 ppm for measuring copper; (d) A PHMB test kit with an indicator range from 0.0 ppm to 75 ppm; or (e) A hydrogen peroxide test kit that is the DPD reagent system with an indicator range from 0.0 to 40 ppm; (2) A phenol red test is used to measure pH with an indicator range from at least 7.0 to 8.0; (3) An alkalinity titration test is used to measure alkalinity as milligrams per liter calcium carbonate; (4) An EDTA (ethylenediamine-tetraacetate) hardness test is used to measure calcium hardness as milligrams per liter calcium carbonate; and (5) A cyanuric acid test kit with an indicator range from 0 to 100 ppm is used if cyanuric acid is used in the pool or spa. B. In order to comply with the requirements of Regulation .46 of this chapter, an owner may monitor: (1) Chlorine and bromine residuals by measuring the oxidation-reduction potential (ORP) of the water before the disinfectant injection point; and (2) The pH with a pH meter. C. If an ORP or pH meter is used, an owner shall ensure that: (1) Periodic calibration is performed on these instruments to assure accurate measurements; and (2) Manual measurements are performed on a daily basis. #### Regulation .48 Sanitary Quality of Water. *COMAR 10.17.01.48* Although routine testing is not required, an owner shall ensure that the water in a public pool or spa: A. Has a coliform bacteria level of less than 1 coliform per milliliter; and B. Is free of pathogenic organisms. #### Regulation .49 Chemical Handling and Storage. *COMAR 10.17.01.49* An owner shall ensure that a: A. Material safety data sheet for a potentially hazardous chemical is available to the operator; B. Chemical is handled, used, stored, and disposed of in accordance with the material safety data sheet and all applicable federal, State, and local codes; and C. Chemical is stored in a chemical storage area which is in compliance with Regulation .29 of this chapter. #### Regulation .50 Control of Infectious and Contagious Diseases. *COMAR 10.17.01.50* A. An owner may not knowingly permit an individual to enter the water of a public pool or spa who has: (1) An infectious or contagious disease that may be transmitted through water; (2) An open cut, blister, or other lesion; or (3) Diarrhea. B. An owner or operator may not prohibit an individual from entering the water of a public pool or spa if a physician certifies that the individual's condition is not infectious or contagious by waterborne transmission. #### Regulation .51 Injury and Illness Reports. *COMAR 10.17.01.51* A public pool or spa owner shall ensure that: A. An injury, drowning, near drowning, or suction entrapment occurring at a pool or spa that results in death or that requires resuscitation or admission to a hospital is reported to the Secretary within 24 hours of the incident; B. A waterborne illness contracted at a pool or spa is reported to the Secretary within 24 hours of the owner's or operator's knowledge of the incident; C. A water rescue by aquatic safety personnel is reported to the Secretary every 3 months during operation or at the seasonal closure of the facility, whichever is more frequent; and D. The information required in §§A—C of this regulation is recorded on a pool and spa injury and illness report form provided by the Secretary. #### Regulation .52 Disinfection of Swimsuits and Towels. *COMAR 10.17.01.52* An owner shall ensure that a swimsuit or towel furnished to an individual by the owner or operator of a public pool or spa is: A. Washed in a washing machine with laundry detergent in hot water with a temperature of at least 175?F; and B. Rinsed in an effective disinfectant or heat dried at 175?F or more for at least 30 minutes after being washed. #### Regulation .53 Variances. *COMAR 10.17.01.53* A. An owner who has been granted a variance by the Secretary before February 10, 1997 may continue to operate under that variance. B. An owner may request a variance from a requirement of this chapter by submitting a written application that: (1) Contains specific details of the alternative procedure proposed by the owner; (2) Specifies the applicable regulation to which the variance pertains; (3) Explains the reason for the request; (4) Provides the name and address of the owner; (5) Provides the name and location of the facility; and (6) Demonstrates that the alternative procedure proposed: (a) Meets or produces the intended effect of the regulation for which the variance is requested, and (b) Maintains the protection of the health and safety of the individuals using the facility at or above the level required by the regulation for which the variance is requested. C. Upon consideration of an application for a variance, the Secretary may grant the request for a variance if the: (1) Applicant has submitted an application in accordance with the provisions of §B of this regulation; (2) Applicant has complied with all other applicable provisions of this chapter; (3) Application is justified due to physical limitation of the existing layout of the facility; and (4) Secretary determines that the alternative procedure proposed by the applicant: (a) Meets or produces the intended effect of the regulation, and (b) Maintains the protection of the health and safety of the individuals using the facility at or above the level required by the regulation at issue. D. The Secretary shall grant or deny an application for a variance in writing and shall mail the decision to the applicant within 60 days of the date the application for a variance is received by the Department. E. If the determination of the Secretary is to deny a variance request that has been made in compliance with the provisions of §B of this regulation, the applicant may file an appeal of the denial in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and shall contact the Secretary within 10 days of receipt of the denial to preserve a right to a hearing. #### Regulation .54 Compliance Schedules. *COMAR 10.17.01.54* A. The owner of a public pool or spa that has a structure, equipment, or appurtenance that is not in compliance with this chapter as determined by the Secretary may submit to the Secretary for approval a compliance schedule for meeting the requirements of this chapter. B. The request from an owner for approval of a compliance schedule shall include: (1) The reason that the noncompliance item cannot be immediately corrected; (2) The plan for correction of the noncompliance item; and (3) The time schedule for the correction of the noncompliance item. C. The Secretary may approve the compliance schedule if the: (1) Owner has submitted a written request for approval of a compliance schedule in accordance with §B of this regulation; (2) Time schedule for the correction of the noncompliance item is accepted by the Secretary; and (3) Operation of the pool or spa during the time allowed to bring the pool or spa into compliance does not adversely affect the health and safety of the public. D. The Secretary may not approve a compliance schedule for a newly constructed pool or spa that has not received construction approval under Regulation .08 of this chapter. E. The Secretary shall issue an operating permit or shall refrain from suspending an operating permit to an owner if: (1) A compliance schedule has been approved by the Secretary for the correction of a noncompliance item; (2) The owner is following the approved compliance schedule; and (3) The pool or spa is otherwise in compliance with this chapter. #### Regulation .55 Standardization and Audits of Local Health Departments. *COMAR 10.17.01.55* A. The Department shall: (1) Standardize one employee related to the enforcement of this chapter for each local health department to serve as the local standardization officer; (2) Audit local health department pool and spa programs related to the enforcement of this chapter once every 4 years according to the current audit protocols; and (3) Provide to the local health department a pool and spa program review final report. B. Local health departments shall submit to the Department responses to any deficiencies within the pool and spa program as identified within the pool and spa program review final report within 30 business days of receipt of the report. ### Chapter 02 — Automated External Defibrillators for Swimming Pools **Authority:** Local Government Article, §1-1310, Annotated Code of Maryland **Administrative History:** Effective date: July 7, 2014 (41:13 Md. R. 752) #### Regulation .01 Scope. *COMAR 10.17.02.01* This chapter establishes guidelines for periodic inspections and annual maintenance of the automated external defibrillators at swimming pools. #### Regulation .02 Definitions. *COMAR 10.17.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “AED” means automated external defibrillator as defined in COMAR 30.06.01.01. (2) “AED coordinator” means an individual designated by the county or municipality to meet the requirement of COMAR 30.06.02. (3) “Swimming pool” means a pool that is owned and operated by the governing body of a county or municipality. #### Regulation .03 AED Program Requirements. *COMAR 10.17.02.03* Each county or municipality that owns and operates a swimming pool shall develop and implement an automated external defibrillator program that meets the requirements in the Education Article, §13-517, Annotated Code of Maryland, and COMAR 30.06.02. #### Regulation .04 Installation. *COMAR 10.17.02.04* An AED shall be located within the pool barrier, as defined in COMAR 10.17.01.05. #### Regulation .05 Registration. *COMAR 10.17.02.05* Each swimming pool owned and operated by a county or municipality shall be registered as specified in COMAR 30.06.02.04. #### Regulation .06 Training. *COMAR 10.17.02.06* The AED coordinator shall ensure that at least one individual who has a current AED certification from a national organization is onsite while the swimming pool is open. #### Regulation .07 Quality Assurance and Maintenance. *COMAR 10.17.02.07* A county or municipality that owns and operates a swimming pool shall: A. Maintain the certificate, equipment and supplies as required by COMAR 30.06.02; and B. Submit the reports as required by COMAR 30.06.02 to the Maryland Institute for Emergency Medical Services Systems (MIEMSS). #### Regulation .08 Inspections. *COMAR 10.17.02.08* A. The Department shall: (1) Monitor a swimming pool for compliance with this chapter; and (2) Inspect the swimming pool as necessary for the enforcement of this chapter. B. Right to Inspect. (1) The Department may enter, at reasonable times, the property of a swimming pool for the purposes of inspecting, monitoring, and verifying information relative to the enforcement of this chapter. (2) A person may not deny or interfere with the Department’s entry into a swimming pool under this chapter. (3) An operator shall permit a representative of the Department to examine and copy records of the swimming pool to verify information relative to the enforcement of this chapter. C. Report of Inspection. During a swimming pool inspection, the Department shall: (1) Record the inspection results on an inspection form prescribed by the Department; (2) Identify on the inspection form the conditions found that violate the provisions of this chapter; (3) Notify the swimming pool operator on the inspection form to correct violations by a specific date; and (4) Provide one copy of the inspection report to the swimming pool operator. D. The completed inspection report is a public document that is available for public disclosure in accordance with State Government Article, §§10-611 — 10-628, Annotated Code of Maryland. ### Chapter 03 — *VACANT* ### Chapter 04 — Public Swimming Pools *Repealed — See COMAR 10.17.01* **Administrative History:** Effective date: April 26, 1951 **Administrative History:** Amended effective June 1, 1967; December 1, 1970 **Administrative History:** Chapter revised effective October 20, 1978 (5:21 Md. R. 1587) **Administrative History:** Chapter revised effective May 13, 1991 (18:9 Md. R. 1012) **Administrative History:** Chapter repealed effective February 10, 1997 (24:3 Md. R. 187) ## Subtitle 18 — Human Immunodeficiency Virus (HIV) Infection and Acquired Immunodeficiency Syndrome (AIDS) ### Chapter 01 — Maryland AIDS Drug Assistance Program: Temporary Assistance Program **Authority:** Health-General Article, §§2-104(b), 2-104(j), 2-105(a), and 18-102(a), Annotated Code of Maryland **Administrative History:** Effective date: March 28, 2016 (43:6 Md. R. 408) **Administrative History:** Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .04B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488) #### Regulation .01 Purpose. *COMAR 10.18.01.01* The purpose of the Maryland AIDS Drug Assistance Program’s Temporary Assistance Program is to provide short term assistance to individuals with Human Immunodeficiency Virus (HIV) who: A. Need HIV drugs and other products; B. Have an application for Medical Assistance or Low-Income Subsidy pending; and C. Are considered likely to have their application approved. #### Regulation .02 Definitions. *COMAR 10.18.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus. (2) “Agent” means a case manager, licensed social worker, registered nurse, or any other related professional that assists an individual in submitting an application to the Temporary Assistance Program. (3) “Applicant” means an individual on whose behalf an application has been submitted to the Temporary Assistance Program and whose eligibility status for the Temporary Assistance Program has not yet been determined. (4) “Department” means the Maryland Department of Health. (5) “Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration, and covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04. (6) “Enrollment period” means the period of time a recipient may receive Temporary Assistance Program benefits. (7) “Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice. (8) “Human immunodeficiency virus (HIV)” means the virus that causes AIDS. (9) “Low-Income Subsidy (LIS)” means the federal program available under the Medicare Part D prescription drug program and Medicare advantage plans that assists persons who have limited income to pay for the cost of premiums, deductibles, and copayments. (10) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients. (11) “Medical Assistance” has the meaning specified in COMAR 10.09.24.02. (12) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department per COMAR 10.18.06.04-1. (13) “Recipient” means an individual who is enrolled in the Temporary Assistance Program. (14) “Resident” means an individual: (a) Who is living in the State voluntarily with the intention of making it that individual’s home and not for a temporary purpose; and (b) For whom any temporary absence from the State is coupled with an intent to return so as not to interrupt the continuity of residence. (15) “Temporary Assistance Program (TAP)” means the program administered by the Department that provides short term MADAP services as specified in Regulation .05 of this chapter for low income eligible individuals. #### Regulation .03 Eligibility. *COMAR 10.18.01.03* To be eligible for benefits, an individual shall meet the following criteria: A. Be a resident of Maryland; B. Be infected with HIV; and C. Have a pending application to Medical Assistance or LIS. #### Regulation .04 Application and Enrollment. *COMAR 10.18.01.04* A. Application. (1) The agent of the applicant shall submit a completed TAP application to the Department on the form designated by the Department that includes: (a) Responses to all applicable questions; and (b) A copy of the completed application or other verifiable documentation for Medical Assistance or LIS enrollment. (2) The agent of the applicant or the applicant may voluntarily withdraw the application at any time without prejudice. (3) The Department shall: (a) Review and process a TAP application by the end of the first business day following receipt; (b) Approve a TAP application if the: (i) TAP application is complete; (ii) Applicant is determined to be eligible; and (iii) Department is able to ascertain that the applicant will likely be found eligible for Medical Assistance or LIS; (c) Issue a client identification number if the TAP application is approved; (d) Disapprove a TAP application if the: (i) TAP application is incomplete; or (ii) Agent of the applicant fails to provide sufficient information or documentation to determine eligibility; and (e) Contact the agent of the applicant with the status of the TAP application. B. Enrollment. (1) A recipient shall be approved for coverage beginning the first day of the month in which the: (a) TAP application was received; or (b) Recipient will need access to medications through TAP. (2) Benefits shall end on the date that a determination of Medical Assistance or LIS coverage occurs. #### Regulation .05 Covered Services. *COMAR 10.18.01.05* A. The recipient shall obtain a prescription for each drug or other product ordered for the recipient. B. The Department shall pay for a prescription drug or other product not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for a recipient. #### Regulation .06 Recovery of Payments. *COMAR 10.18.01.06* If benefits have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments. #### Regulation .07 Fraud. *COMAR 10.18.01.07* The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision. #### Regulation .08 Confidentiality. *COMAR 10.18.01.08* Except when communicating with the parties listed in §B of this regulation and unless otherwise authorized by law, the agent of an applicant, or the agent of a recipient, the Department: A. Shall keep all applicant and recipient personal information confidential; B. May not disclose personal information kept on an applicant or recipient without written consent of the: (1) Applicant; (2) Recipient; (3) Applicant’s parent or legal guardian; or (4) Recipient’s parent or legal guardian; C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under: (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations. #### Regulation .09 Availability of Funding and Program Termination. *COMAR 10.18.01.09* A. If sufficient monies are not available to fund TAP, the Department shall take the action necessary to eliminate a deficit which may include program termination. B. If TAP is terminated, the Department shall provide benefits for each current recipient in accordance with Regulation .04B of this chapter. ### Chapter 02 — HIV and CD4+ Investigations and Case Reporting **Authority:** Health-General Article, §§2-104(b), 4-101, 4-102, 18-102, 18-103, 18-201.1, 18-202.1, 18-205, 18-207, and 18-215;State Government Article, §10-617; Annotated Code of Maryland **Administrative History:** Effective date: February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Chapter revised effective September 8, 2008 (35:18 Md. R. 1600) **Administrative History:** Regulation .01 amended effective May 18, 2020 (47:10 Md. R. 518 **Administrative History:** Regulation .02 amended effective May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .02B, C amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385); May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .06A amended effective May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .07 amended effective May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .08 amended effective May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .08C amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .09B amended effective May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385) #### Regulation .01 Scope. *COMAR 10.18.02.01* A. This chapter establishes the requirements for: (1) Physician reporting of a: (a) Case of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); and (b) Birth of an infant whose mother has tested positive for HIV; (2) Institution reporting of a case of HIV or AIDS; (3) Laboratory reporting of a test result for: (a) HIV detection; (b) HIV viral load; (c) CD4+ cell count or percentage; or (d) HIV genotype sequence; and (4) Follow-up of: (a) A physician's report of HIV or AIDS; (b) A physician's report of an infant whose mother has tested positive for HIV; (c) An institution's report of HIV or AIDS; and (d) A laboratory’s report of a test result for: (i) HIV detection; (ii) HIV viral load; (iii) CD4+ cell count or percentage; or (iv) HIV genotype sequence infection or CD4+ count. B. Except as noted in §C of this regulation, this chapter applies to all instances of laboratory testing of specimens from a human body for: (1) HIV detection; (2) HIV viral load; (3) CD4+ cell count or percentage; or (4) HIV genotype sequence. C. This chapter does not apply if the specimen from a human body is: (1) Not tested for: (a) HIV detection; (b) HIV viral load; (c) CD4+ cell count or percentage; or (d) HIV genotype sequence; (2) Tested for HIV detection solely for the purpose of determining the suitability of the source individual as a prospective donor of blood, semen, or tissue; (3) Taken from a patient at a designated anonymous HIV test site solely for the purpose of performing an anonymous HIV test; (4) Tested for HIV detection as part of research conducted by an institution within Maryland under the following conditions: (a) All personal identifiers are removed from the specimen before testing; (b) The specimen cannot be linked to the individual from whom the specimen was taken; (c) The result cannot be linked to the individual from whom the specimen was taken; and (d) The research protocol has been approved by an institutional review board; (5) Tested for HIV detection as part of research conducted under a research protocol approved by an institutional review board of an institution located outside of Maryland; (6) Taken from a patient known to reside outside of the United States; or (7) Tested for HIV detection as part of a research project that has been approved under Regulation .02 of this chapter for an exemption. #### Regulation .02 Exemptions. *COMAR 10.18.02.02* A. Qualifications for Exemption. A research project that meets both of the following criteria may be eligible for exemption from the HIV reporting requirements of Regulation .06 of this chapter: (1) The research project has been approved by an institutional review board; and (2) The research: (a) Is intended to determine the safety or effectiveness of a vaccine that would produce immunity against HIV; or (b) Is not primarily intended to provide medical treatment to participants. B. Application for Exemption. The principal investigator of a research project shall submit all of the following documents to the Department in order to apply for an exemption: (1) A copy of the research protocol approved by the institutional review board of the institution conducting the research; and (2) A copy of the notice stating that the protocol has been approved by the institutional review board of the institution conducting the research. C. Approval. (1) The Director of the Infectious Disease Prevention and Health Services Bureau or the Director’s designee shall review the application submitted under §B of this regulation to determine whether the: (a) Application is complete; and (b) Research protocol meets the criteria specified in §A of this regulation. (2) If the application is complete and the research protocol meets the specified criteria, the Director shall grant an exemption from the requirements set forth in Regulation .06 of this chapter for any specimen tested for HIV detection under the research project approved for exemption. (3) The Director shall mail written notification to the applicant of an exemption under this regulation within 30 days of receipt of the application, stating whether the exemption: (a) Has been approved; (b) Has been denied and the reason for the denial; or (c) Cannot be processed until further information is provided to the Department. D. Responsibilities of the Principal Investigator. If a research project is granted an exemption under §C of this regulation, the principal investigator of the research project shall send to each laboratory to which specimens collected under the research protocol will be sent to be tested for HIV detection a copy of the notification from the Director issued pursuant to §C(3)(a) of this regulation to verify that the project has been exempted from the reporting requirements of Regulation .06 of this chapter. E. Scope of Exemption. (1) Except as indicated in §E(2) of this regulation, an exemption approved under §C of this regulation does not relieve the principal investigator, a laboratory director, or another individual from a reporting requirement contained in Health-General Article, §18-201.1, 18-202.1, 18-205, or 18-207, Annotated Code of Maryland, or Regulation .06 of this chapter. (2) A principal investigator, laboratory director, or other individual is not required to report HIV detection test results if the test is done as part of the research project and the individual tested: (a) Meets the criteria for participation in the research project set forth in the research protocol submitted under §B(1) of this regulation; and (b) Has signed an informed consent form agreeing to participate in the research project. #### Regulation .03 Definitions. *COMAR 10.18.02.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquired immunodeficiency syndrome (AIDS)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland. (2) “Anonymous” means that a patient does not use the patient's name as identification and can only be identified through use of a code. (3) “Assigned laboratory number” means a number assigned to a laboratory by the Department for use in filing reports of HIV infection or CD4+ count. (4) “Case” means an individual who has: (a) Been clinically diagnosed as having HIV or AIDS; or (b) Laboratory evidence of being infected by HIV. (5) “Clinical material” means: (a) An organism isolated from a clinical specimen; (b) Material derived or prepared from a clinical specimen in which evidence of a communicable disease has been identified or detected; or (c) If neither §B(5)(a) nor §B(5)(b) of this regulation is available, material from an individual already held by the medical laboratory, in the following order of preference: (i) A patient specimen; (ii) Nucleic acid; or (iii) Other laboratory material. (6) “Clinical or infection control practitioner” means a physician, infection control nurse, physician assistant, nurse practitioner, or other clinical staff designated by the administrative head of an institution to report under Health-General Article, §18-202.1, Annotated Code of Maryland. (7) “Department” means the Maryland Department of Health. (8) “Designated anonymous HIV test site” means an HIV counseling and testing site designated by the Department as a site where a patient may have an anonymous HIV test. (9) “Drug” means a drug that has been: (a) Licensed by the United States Food and Drug Administration (FDA); or (b) Approved by the FDA as an investigational new drug. (10) “Exemption” means a research project meeting certain criteria, with the result that no reporting is required under this chapter. (11) “Health officer” means the health officer in each of the 23 counties and the Commissioner of Health in Baltimore City or the duly designated representative of the health officer. (12) “Human immunodeficiency virus (HIV)” has the meaning stated in Health-General Article, §§18-201.1(a) and 18-202.1(b), Annotated Code of Maryland. (13) “Institution” means an entity that employs an individual licensed to practice osteopathy or medicine by the State. (14) “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR Part 46 to review the use of human subjects in proposed research. (15) “Laboratory examination order” means the written document signed by a physician or other authorized individual that specifies one or more laboratory examinations to be performed in regard to a specified patient. (16) “Newborn HIV exposure” means a newborn infant whose mother has tested positive for HIV infection. (17) “Physician” means an individual licensed to practice osteopathy or medicine by the State or the physician's designee working under the supervision of the physician. (18) “Secretary” means the Secretary of Health or the Secretary's designee. #### Regulation .04 Physician Responsibility. *COMAR 10.18.02.04* A. A physician shall: (1) Report a case of HIV or AIDS or newborn HIV exposure for a patient under the physician's care to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and (2) Include the information requested on the form. B. A physician may not transmit information to the health officer or the Secretary about a case of HIV or AIDS or newborn HIV exposure by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. C. A physician authorized to order laboratory examinations shall include all of the following information on the written laboratory examination order for a test covered by this chapter: (1) Name, date of birth, race, ethnicity, and gender of the patient; (2) Street address, city, state, and zip code of the patient's residence; and (3) Name, address, and telephone number of the physician ordering the test. D. A physician who reports a case of HIV or AIDS or a newborn HIV exposure or orders a laboratory examination for a test covered by this chapter shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland. E. A physician working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report an HIV or AIDS case if the administrative head of the institution has designated an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners other than the physician to be responsible for reporting on behalf of all clinical and infection control practitioners in the facility, as set forth in Regulation .05 of this chapter. #### Regulation .05 Responsibilities of Clinical and Infection Control Practitioners in Institutions. *COMAR 10.18.02.05* A. A clinical or infection control practitioner working in an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, shall: (1) Report a case of HIV or AIDS under the care of the institution to the health officer within 48 hours, by phone or in writing on a form provided by the Secretary; and (2) Include the information requested on the form. B. A clinical or infection control practitioner may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. C. A clinical or infection control practitioner who reports a case of HIV or AIDS shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report as defined in Health-General Article, §18-207, Annotated Code of Maryland. D. The administrative head of an institution required to report as set forth in Health-General Article, §18-202.1, Annotated Code of Maryland, may designate an individual clinical or infection control practitioner or a specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical and infection control practitioners in the facility. E. A clinical or infection control practitioner working in an institution required to report as defined in Health-General Article, §18-202.1, Annotated Code of Maryland, is not required to report HIV or AIDS cases if the administrative head of the institution has designated a different individual clinical or infection control practitioner or specific set of clinical or infection control practitioners who shall be responsible for reporting on behalf of all clinical practitioners in the facility. #### Regulation .06 Responsibilities of Laboratory Directors. *COMAR 10.18.02.06* A. Except as provided in Regulations .01C and .02 of this chapter, the director of a medical laboratory shall: (1) Submit a report to the health officer for the jurisdiction where the laboratory is located, within 48 hours after an examination of a specimen from a human body shows one of the following: (a) A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results; (b) A quantitative or qualitative HIV viral load test result, including undetectable; (c) A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or (d) An HIV genotype sequence test result; (2) Use the form provided by the Department in making the report required under §A(1) of this regulation; (3) Include all of the following information in the report required under §A(1) of this regulation: (a) Name and address of laboratory or assigned laboratory number; (b) Date the specimen was obtained from the patient; (c) Type and result of laboratory test, that is, HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence; (d) Name, date of birth, race, ethnicity, and gender of the patient; (e) Street address, city, state, and zip code of the patient's residence; (f) Name of the physician authorizing the laboratory examination; and (g) Address and telephone number of the physician authorizing the laboratory examination; and (4) Contact the physician authorizing the laboratory examination to obtain any of the information, as required by §A(3) of this regulation, that is not provided on the laboratory examination order. B. A laboratory director may not transmit to the health officer or the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. C. The laboratory director shall, at the request of the Secretary, make available to the Secretary any remaining clinical material from tested individuals. D. This regulation does not relieve a physician of the duty to report as set forth in Health-General Article, §§18-201.1 and 18-202.1, Annotated Code of Maryland. #### Regulation .07 Out-of-State Laboratories. *COMAR 10.18.02.07* An out-of-State laboratory that holds a permit to operate issued by Maryland and performs HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence tests shall submit the report required under Regulation .06 of this chapter to the Secretary. #### Regulation .08 Responsibility of Health Officer. *COMAR 10.18.02.08* A. This regulation establishes requirements for follow-up by the health officer of a report of HIV or AIDS or newborn HIV exposure or laboratory report of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence. B. This regulation does not supplant or otherwise modify the: (1) Physician's obligation to report a case of HIV or AIDS or newborn HIV exposure under Health-General Article, §18-201.1, Annotated Code of Maryland, and Regulation .04 of this chapter; (2) Clinical or infection control practitioner's obligation to report a case of HIV or AIDS under Health-General Article, §18-202.1, Annotated Code of Maryland, and Regulation .05 of this chapter; and (3) Laboratory director’s obligation to report a test result of HIV detection, HIV viral load, CD4+ cell count or percentage, or HIV genotype sequence under Health-General Article, §18-205, Annotated Code of Maryland, and Regulation .06 of this chapter. C. Upon receipt of a report from a physician pursuant to Regulation .04 of this chapter, a clinical or infection control practitioner pursuant to Regulation .05 of this chapter, the health officer shall: (1) Determine whether the case of HIV, the case of AIDS, or the newborn HIV exposure has been reported previously; (2) Complete the case investigation if the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and (3) Submit the HIV/AIDS case report as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously. D. Upon receipt of a test result report from a laboratory director pursuant to Regulation .06 of this chapter, the health officer shall: (1) Determine whether the report matches to a case of HIV, a case of AIDS, or a newborn HIV exposure that has been reported previously, and submit the report to the Department if the report matches; (2) Complete a case investigation if the report indicates the patient has HIV or AIDS or is a newborn HIV exposure and the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; (3) Submit the case report, as set forth in Health-General Article, §18-207, Annotated Code of Maryland, to the Department if the case of HIV or the case of AIDS or the newborn HIV exposure has not been reported previously; and (4) Retain a nonmatching report for up to 4 years, rematching the report, not less than annually, to test result reports and to cases of HIV or cases of AIDS or newborn HIV exposures that had not been reported previously, to identify new matches, and submit the report to the Department if the report matches. E. A health officer may not transmit to the Secretary information about a case of HIV or AIDS by facsimile or another electronic method unless directed by the Secretary to submit the information by electronic method. #### Regulation .09 Record Maintenance and Confidentiality. *COMAR 10.18.02.09* A. A person that submitted a report of HIV or AIDS or newborn HIV exposure shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04—.06 of this chapter. B. Except for a designated anonymous HIV test site, a person that ordered the laboratory examination shall make available to the health officer or the Secretary the information necessary to compile an HIV/AIDS case report, according to Regulations .04 and .05 of this chapter, upon receipt of one of the following: (1) A result on a test designed to detect in a sample the presence of HIV in accordance with Health-General Article, §18-207(b)(1), Annotated Code of Maryland, including negative results; (2) A qualitative or quantitative HIV viral load test result, including undetectable; (3) A CD4+ cell test result, count, or percentage in an individual not known to be HIV negative; or (4) An HIV genotype sequence test result. C. Confidentiality. (1) A report required under this chapter is: (a) Confidential; (b) Not open to public inspection; (c) Not a medical record under Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (d) Subject to the confidentiality requirements of Health-General Article, Title 4, Subtitle 1, Annotated Code of Maryland. (2) The reports and any proceedings, records, or files relating to the reports required under this chapter are not discoverable and are not admissible in evidence in any civil action. (3) Section C(1) of this regulation does not apply to a disclosure by the Secretary to another governmental agency performing its lawful duties pursuant to State or federal law where the Secretary determines that the agency to whom the information is disclosed will maintain the confidentiality of the disclosure. ### Chapter 03 — AIDS Investigations and Case Reporting *Repealed* **Administrative History:** Effective date: February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .03B amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .04C amended effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulations .01—.05 repealed effective May 18, 2020 (47:10 Md. R. 518) ### Chapter 04 — Disease Control *Repealed* **Administrative History:** Effective date: February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulations .01 — .03 repealed effective April 24, 2017 (44:8 Md. R. 403) ### Chapter 05 — Maryland AIDS Drug Assistance Program: Eligibility **Authority:** Health General Article, §§2-104(b) and(i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.15 adopted as an emergency provision effective November 27, 2002 (29:25 Md. R. 1979); adopted permanently effective February 17, 2003 (30:3 Md. R. 180) **Administrative History:** Regulation .01B amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .02 amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .03B, C amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .03C amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .05 amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .05A amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .05E amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .06C amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .07 repealed as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); repealed permanently effective May 26, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .08A amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .08B amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .09C adopted effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .11 amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .15A amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408) **Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488); October 14, 2024 (51:20 Md. R. 899) **Administrative History:** Regulation .02D amended effective October 14, 2024 (51:20 Md. R. 899) **Administrative History:** Regulation .02D, E amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .03 amended effective October 14, 2024 (51:20 Md. R. 899) **Administrative History:** Regulation .03B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .04A, D amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .09B amended effective May 20, 2019 (46:10 Md. R. 488) #### Regulation .01 Definitions. *COMAR 10.18.05.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus. (2) “Applicant” means an individual who has submitted an application to the Maryland AIDS Drug Assistance Program and whose eligibility status for the Maryland AIDS Drug Assistance Program has not yet been determined. (3) “Department” means the Maryland Department of Health. (4) “Disenroll” means to end Maryland AIDS Drug Assistance Program benefits. (5) “Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration and covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04. (6) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits. (7) “Gross household income” means the income derived from sources provided in Regulation .02E of this chapter. (8) “Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice. (9) “Human Immunodeficiency Virus (HIV)” means the virus that causes AIDS. (10) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients. (11) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. (12) “Recipient” means an individual who is enrolled in MADAP. (13) “Resident” means an individual: (a) Who is living in the State voluntarily with the intention of making it that individual’s home and not for a temporary purpose; and (b) For whom any temporary absence from the State is coupled with an intent to return so as not to interrupt the continuity of the residence. (14) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to Regulation .03B(1)(a) of this chapter. #### Regulation .02 Eligibility. *COMAR 10.18.05.02* A. Except when an individual is enrolled in Medical Assistance but does not have prescription coverage assistance, an individual who is eligible for Medical Assistance is not eligible for MADAP. B. To be eligible for benefits, an individual shall meet the following criteria: (1) Residency; (2) Medical; and (3) Financial. C. Residency Criteria. To meet the residency criteria the individual shall be a resident of Maryland. D. Medical Criteria. To meet the medical criteria the individual shall be infected with HIV as verified by the Department. E. Financial Criteria. (1) To meet the financial criteria the individual shall have a projected gross household income less than or equal to 500 percent of the Federal Poverty Level Guidelines as updated annually in the Federal Register by the U.S. Department of Health and Human Services under authority of 42 U.S.C. §9902(2). (2) Projected gross household income shall be determined based on what can reasonably be expected to be received during the 12-month period beginning with the month in which the completed application is filed or verification of eligibility is submitted. (3) Gross household income includes income derived from: (a) Wages and salaries, including tips; (b) Net income from self-employment or business; (c) Unemployment income; (d) Social security payments, including disability payments; (e) Alimony; (f) Retirement income; (g) Pension income; (h) Investment income; (i) Rental income; and (j) Other taxable income, such as prizes, awards, and gambling winnings. (4) Gross household income under this chapter does not include income derived from: (a) Child support; (b) Gifts; (c) Supplemental Social Security Income; (d) Veterans’ disability payments; (e) Workers’ compensation; and (f) Proceeds from loans, such as student loans, home equity loans, or bank loans. #### Regulation .03 Application and Enrollment. *COMAR 10.18.05.03* A. Application. (1) Applicant. (a) An applicant shall submit a completed application to the Department on the form designated by the Department that includes: (i) Responses to all required fields and applicable questions; and (ii) Supporting documentation related to residency, medical, and financial eligibility criteria. (b) An applicant may voluntarily withdraw the application at any time without prejudice. (c) An applicant may submit a new application at any time. (2) The Department shall: (a) Approve the application if the: (i) Application is complete; and (ii) Applicant is determined to be eligible; (b) Disapprove the application if the: (i) Application is incomplete; (ii) Applicant fails to provide sufficient information or documentation to determine eligibility; or (iii) Applicant provides the appropriate documentation but is determined ineligible; and (c) Provide the applicant with written notice of the final disposition of the application. B. Enrollment. (1) If the Department requests it, a recipient shall: (a) Attest to continuing eligibility: (b) Submit a completed verification of eligibility form; and (c) Provide supporting documentation. (2) A recipient’s MADAP benefits shall be suspended, effective at the end of the month following the month the verification of eligibility is due, if the recipient fails to attest to eligibility for MADAP. (3) The Department shall: (a) Enroll an applicant who has been determined eligible with the stipulation that eligibility must be verified as requested by the Department; (b) Establish enrollment in MADAP beginning on the first day of the month in which the: (i) Department approves the application; or (ii) Recipient will need to access medications through MADAP; (c) Redetermine eligibility if the Department receives information that may affect eligibility; and (d) Send any relevant verification of eligibility forms to the recipient at least 45 calendar days before the forms are due to be submitted to the Department. #### Regulation .04 Changes in Eligibility and Disenrollment. *COMAR 10.18.05.04* A. A recipient shall notify the Department within 10 business days of a change in: (1) Availability of third-party payment for services covered under MADAP; (2) Gross household income; or (3) Address. B. If a change reported in §A of this regulation results in a recipient no longer qualifying for MADAP, the Department shall: (1) Determine the recipient ineligible for MADAP; and (2) Disenroll the recipient. C. The notice of intended action, which notifies the recipient of the disenrollment, shall: (1) Be mailed to the recipient at least 15 business days before the effective date of disenrollment; (2) Include an explanation of the action; (3) Cite the regulation supporting the action; and (4) Explain the right of the recipient to request reconsideration or an appeal of the decision. D. If the recipient is determined to be ineligible before the next verification of eligibility is due to be submitted to the Department because of a change in eligibility, the disenrollment shall be the earlier of: (1) The date on which the recipient’s next verification of eligibility is due to be submitted to the Department; or (2) The first day of the month that is at least 15 calendar days after the date of the notice of ineligibility for MADAP benefits. E. If the recipient’s Medical Assistance coverage is pending or active, the recipient shall be disenrolled, as determined by the Department. #### Regulation .05 Reconsideration and Appeal. *COMAR 10.18.05.05* A. An applicant or recipient who has been notified by the Department of ineligibility for or disenrollment from MADAP benefits may request reconsideration of the decision by submitting additional supporting documentation or information to the Department within 30 business days of notification. B. If an applicant or recipient submits a timely request for reconsideration, the Department shall: (1) Review all additional supporting documentation, within 5 business days of the Department’s receipt of the request for reconsideration; and (2) Issue a final decision in writing to the applicant or recipient. C. If an applicant or recipient is dissatisfied with the final decision of the Department, the applicant or recipient may appeal the reconsideration by requesting in writing for a hearing with the Department. D. The Office of Administrative Hearings shall: (1) Conduct a hearing according to the procedures set forth in COMAR 28.02.01; (2) Hold a hearing to review the decision within 45 days of the postmarked date on the letter requesting a hearing; and (3) Issue a decision in writing to the applicant or recipient. #### Regulation .06 Recovery of Payments. *COMAR 10.18.05.06* If MADAP benefits have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments. #### Regulation .07 Fraud. *COMAR 10.18.05.07* The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision. #### Regulation .08 Confidentiality. *COMAR 10.18.05.08* Unless otherwise authorized by law, the Department: A. Shall keep all applicant and recipient personal information confidential; B. May not disclose personal information kept on an applicant or recipient without written consent of the: (1) Applicant; (2) Recipient; (3) Applicant’s parent or legal guardian; or (4) Recipient’s parent or legal guardian; C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under: (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations. #### Regulation .09 Availability of Funding and Program Termination. *COMAR 10.18.05.09* A. If sufficient monies are not available to fund MADAP, the Department shall take the action necessary to eliminate a deficit which may include MADAP termination. B. If MADAP is terminated the Department shall provide benefits for each current recipient until the earlier of: (1) The date on which the next verification of eligibility is due to be submitted to the Department; or (2) Six months from the date MADAP is terminated. ### Chapter 06 — Maryland AIDS Drug Assistance Program: Pharmacy Services **Authority:** Health General Article, §§2-104(b) and(i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.12 adopted as an emergency provision effective November 27, 2002 (29:25 Md. R. 1979); adopted permanently effective February 17, 2003 (30:3 Md. R. 180) **Administrative History:** Regulation .01B amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .01B amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .04B amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .04C adopted effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .04-1 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .04-2 adopted as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); adopted permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .04-2 amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .04-2 amended effective September 15, 2014 (41:18 Md. R. 1010) **Administrative History:** Regulation .05A amended as an emergency provision effective February 20, 2007 (34:7 Md. R. 694); amended permanently effective June 18, 2007 (34:12 Md. R. 1067) **Administrative History:** Regulation .05B amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .06A amended as an emergency provision effective November 14, 2003 (30:24 Md. R. 1737); amended permanently effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .06A amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .12A amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408) **Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .02 amended effective January 19, 2026 (53:1 Md. R. 20) **Administrative History:** Regulation .03A amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .04B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .04-1 amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .04-2 repealed effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488), October 14, 2024 (51:20 Md. R. 899) **Administrative History:** Regulation .08 amended effective October 14, 2024 (51:20 Md. R. 899) **Administrative History:** Regulation .09A amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .10 amended effective October 14, 2024 (51:20 Md. R. 899) **Administrative History:** Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 488) #### Regulation .01 Definitions. *COMAR 10.18.06.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus. (2) “Department” means the Maryland Department of Health. (3) “Drug” means an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease licensed by the U.S. Food and Drug Administration and covered by the Maryland AIDS Drug Assistance Program as specified in Regulation .04 of this chapter. (4) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits. (5) “Health care practitioner” means any individual licensed to prescribe U.S. Food and Drug Administration-approved drugs or other products in the state in which they practice. (6) “Human Immunodeficiency Virus (HIV)” means the virus that causes AIDS. (7) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in Regulation .04 of this chapter for enrolled recipients. (8) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. (9) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to Regulation .04-1 of this chapter. (10) “Pharmacist” means an individual registered and licensed to practice pharmacy in the state where the prescription is filled. (11) “Pharmacy” means an establishment or institution registered and licensed to dispense U.S. Food and Drug Administration-approved drugs or other products to the public in the state in which the establishment or institution is located. (12) “Preauthorization” means an approval required before the dispensing of the prescription. (13) “Prescription” means a direction, usually written by a health care provider authorized to prescribe drugs and other products and sent to the pharmacist for the preparation, dispensing, and directions for use of a drug or other product not excluded from the open formulary. (14) “Recipient” means an individual who is enrolled in MADAP. #### Regulation .02 Permit and License Requirements. *COMAR 10.18.06.02* A. To qualify for participation in MADAP, a pharmacy shall first obtain a permit from: (1) The State Board of Pharmacy, pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland; or (2) The appropriate agency in the state in which the pharmacy is located. B. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19. C. To qualify for participation in MADAP, a health care practitioner shall be: (1) Licensed; and (2) Legally authorized to practice medicine in accordance with applicable state and federal laws. #### Regulation .03 Conditions for Participation. *COMAR 10.18.06.03* A. To participate in MADAP, a pharmacy shall: (1) Be enrolled in Medical Assistance, be a mail order company that accepts payments from the Department, or submit a request for exception to, and receive approval from, the Department; (2) Accept payment by the Department as payment in full for the professional services rendered and make no additional charges to the recipient or the recipient’s family; (3) Maintain records in accordance with standards established by Medical Assistance; (4) Maintain prescriptions for a minimum of 5 years and make them available for inspection, upon request, to the Department or its designee; (5) Provide services without regard to race, color, creed, age, sex, sexual orientation, gender identity, national origin, marital status, or disability; and (6) Bill the recipient’s third-party insurance payer in accordance with the payer’s requirements in order to reduce the cost to be paid by the Department. B. A pharmacy may not: (1) Knowingly employ a person who has been disqualified from Medical Assistance; or (2) Place a restriction on a recipient’s right to select a pharmacy of the recipient’s choice. #### Regulation .04 Covered Services. *COMAR 10.18.06.04* A. The recipient shall obtain a prescription for each drug or other product ordered for the recipient. B. The Department shall pay for a prescription drug or other product not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for the recipient. #### Regulation .04-1 Formulary. *COMAR 10.18.06.04-1* The Department shall: A. Maintain a list of drugs and other products excluded from the open formulary; and B. Make available electronically the list of drugs and other products excluded from the open formulary. #### Regulation .05 Limitations on Covered Services. *COMAR 10.18.06.05* A. A pharmacist may not dispense more than a 100-day supply of a prescribed drug or other product. B. The Department may not pay for: (1) A drug or other product prescribed as part of a recipient’s care in a correctional institution, inpatient hospital, nursing home, or long-term care setting; or (2) Drugs or other products excluded from the open formulary, unless the Department grants the recipient preauthorization. #### Regulation .06 Preauthorization Requirement. *COMAR 10.18.06.06* A pharmacist shall obtain preauthorization for each prescription or refill before dispensing a drug or other product marked as restricted. #### Regulation .07 Payment Procedures. *COMAR 10.18.06.07* A. Except as provided in §§B and C of this regulation, the Department shall pay a pharmacy in accordance with the procedures of the Medical Assistance Pharmacy Services Program set forth at COMAR 10.09.03.07. B. If the Department or the recipient tells the pharmacy that the recipient has or may have third-party insurance coverage to offset some or all of the cost for services provided under MADAP, the pharmacy shall: (1) Bill the third-party payer the pharmacy’s usual and customary charge for the services provided; and (2) Bill the Department for the difference between the pharmacy’s usual and customary charge and the anticipated third-party receipts. C. If the recipient has third-party insurance coverage, the Department shall pay the pharmacy the difference between the pharmacy’s usual and customary charge and the anticipated third-party insurance receipts, not to exceed the amount permitted under COMAR 10.09.03.07F and G. D. The Department shall make payments related to MADAP in accordance with any applicable policies and procedures for the administration of federal funds issued pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009, and any subsequent modifications to the Act. #### Regulation .08 Recovery and Reimbursement. *COMAR 10.18.06.08* The Department shall follow the same procedures for recovery and reimbursement as the Medical Assistance Program in COMAR 10.09.03.08. #### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions. *COMAR 10.18.06.09* A. If the Department determines that a pharmacy or the pharmacy’s employee, or both, has failed to comply with federal or State laws and regulations, the Department may: (1) Suspend the pharmacy from MADAP; (2) Withhold payment to the pharmacy; or (3) Both. B. Removal of a pharmacy or a pharmacy’s employee from Medical Assistance shall result in removal from MADAP. C. The Department: (1) May consult with the State Board of Pharmacy regarding the actions of a pharmacy, such as: (a) A breach of confidentiality; (b) Refusal of service; or (c) Discrimination; and (2) Shall consider the findings and recommendations of the State Board of Pharmacy when deciding on the imposition of a sanction as stated in §A of this regulation. D. The Department shall give the pharmacy written notice of the Department’s intention to impose sanctions referred to in §A of this regulation, including: (1) The effective date of the proposed action; (2) The reason for the proposed action; and (3) The pharmacy’s right to appeal the proposed action. E. A pharmacy voluntarily withdrawing from MADAP or removed or suspended from MADAP according to this regulation shall notify a recipient that the pharmacy is no longer a MADAP pharmacy. #### Regulation .10 Appeal Procedures. *COMAR 10.18.06.10* A pharmacy filing an appeal shall do so in accordance with the Medical Assistance Program as set forth at COMAR 10.09.03.10. #### Regulation .11 Confidentiality. *COMAR 10.18.06.11* Unless otherwise authorized by law, the Department: A. Shall keep all applicant and recipient personal information confidential; B. May not disclose personal information kept on a recipient without written consent of the: (1) Recipient; or (2) Recipient’s parent or legal guardian; C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under: (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations. #### Regulation .12 Availability of Funding and Program Termination. *COMAR 10.18.06.12* A. If sufficient monies are not available to fund MADAP, the Department shall take the action necessary to eliminate a deficit which may include MADAP termination. B. If MADAP is terminated, the Department shall provide benefits for each current recipient in accordance with COMAR 10.18.05.09B. ### Chapter 07 — Maryland AIDS Drug Assistance Program: Health Insurance (MADAP-PLUS) **Authority:** Health-General Article, §§2-104(b) and(i) and 2-105(a) and (b), Annotated Code of Maryland **Administrative History:** Effective date: February 3, 2003 (30:2 Md. R. 76) **Administrative History:** Regulation .01B amended effective December 27, 2010 (37:26 Md. R. 1788); March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .03 amended effective December 27, 2010 (37:26 Md. R. 1788); March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .04 amended as an emergency provision effective January 1, 2014 (41:4 Md. R. 298); amended permanently effective May 26, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .04D amended as an emergency provision effective August 11, 2004 (31:18 Md. R. 1348); amended permanently effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .04D, E amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .06D amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .10A amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .16A amended effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408) **Administrative History:** Regulation .01B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .02 amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .03C amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .06F amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .07B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .11B amended effective May 20, 2019 (46:10 Md. R. 488) #### Regulation .01 Definitions. *COMAR 10.18.07.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquired Immunodeficiency Syndrome (AIDS)” means the medical condition caused by the Human Immunodeficiency Virus. (2) “Applicant” means an individual who has submitted an application to the Maryland AIDS Drug Assistance Program—Plus and whose eligibility status for the Maryland AIDS Drug Assistance Program—Plus has not yet determined. (3) “Core medical services” means a set of direct health care services as specified by the Ryan White Care Act Part B Program administered by the U.S. Health Resource and Services Administration. (4) “Department” means the Maryland Department of Health. (5) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits. (6) “Health care provider” means an individual licensed to provide core medical services in the state where services are rendered. (7) “Human immunodeficiency virus (HIV)” means the virus that causes AIDS. (8) “Maryland AIDS Drug Assistance Program (MADAP)” means the program administered by the Department that provides services specified in COMAR 10.18.06.04 for enrolled recipients. (9) “Maryland AIDS Drug Assistance Program—Plus (MADAP-Plus)” means the program administered by the Department to pay insurance premiums, copays, coinsurance, and deductibles for drugs and core medical services. (10) “Medical Assistance” has the meaning stated in COMAR 10.09.24.02. (11) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1. (12) “Recipient” means an individual who is enrolled in MADAP-Plus. (13) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to COMAR 10.18.05.03B(1)(a). #### Regulation .02 Eligibility. *COMAR 10.18.07.02* A. To be eligible for MADAP-Plus coverage, an individual shall be: (1) Enrolled in MADAP; and (2) Receiving or eligible to receive health insurance and prescription drug coverage. B. An individual who is eligible for employer-sponsored health insurance with a prescription drug formulary that includes antiretroviral medications may not receive premium assistance unless the individual is: (1) Enrolled in the employer-sponsored health plan; and (2) Paying 50 percent or more of the total monthly health insurance premiums. #### Regulation .03 Application and Enrollment. *COMAR 10.18.07.03* A. An applicant shall apply in the manner set forth in COMAR 10.18.05.03A. B. A recipient and the Department shall meet the enrollment responsibilities set forth in COMAR 10.18.05.03B. C. The duration of the recipient’s enrollment in MADAP-Plus may not extend beyond the duration of the recipient’s enrollment in MADAP. #### Regulation .04 Covered Services. *COMAR 10.18.07.04* A. The Department shall pay for health and prescription plan premiums with a prescription drug formulary that includes antiretroviral medications. B. Within the limits established by the Department and in accordance with policy guidance issued by the Health Resources and Services Administration, the Department: (1) Shall pay for copays, coinsurance, and deductibles for drugs; and (2) May pay for copays, coinsurance, and deductibles associated with core medical services. #### Regulation .05 Changes in Eligibility and Disenrollment. *COMAR 10.18.07.05* A. A recipient shall inform the Department of a change in eligibility as set forth in COMAR 10.18.05.04A. B. If a change reported in §A of this regulation results in a recipient no longer qualifying for MADAP-Plus, the Department shall: (1) Determine the recipient ineligible for MADAP-Plus; and (2) Disenroll the recipient. C. If a MADAP-Plus recipient is disenrolled from MADAP, the recipient is automatically disenrolled from MADAP-Plus. #### Regulation .06 Reconsideration and Appeal. *COMAR 10.18.07.06* A. An applicant or recipient who has been notified by the Department of disenrollment or ineligibility for MADAP-Plus benefits may request reconsideration of the decision by submitting additional supporting documentation or information to the Department within 30 business days of notification. B. If an applicant or recipient submits a timely request for reconsideration, the Department shall: (1) Review all additional supporting documentation, within five business days of the Department’s receipt of the request for reconsideration; and (2) Issue a final decision in writing to the applicant or recipient. C. If an applicant or recipient is dissatisfied with the final decision of the Department, the applicant or recipient may appeal the reconsideration by requesting in writing for a hearing with the Department. D. The Office of Administrative Hearings shall: (1) Conduct a hearing according to the procedures set forth in COMAR 28.02.01; (2) Hold a hearing to review the decision within 45 days of the postmarked date on the letter requesting a hearing; and (3) Issue a decision in writing to the applicant or recipient. E. The Department shall pay any health insurance plan or prescription drug plan costs due pending a decision by the Office of Administrative Hearings. F. If the final decision finds in favor of the Department, the Department shall, upon the date of the decision, cease paying the health insurance costs allowed under this chapter and seek recovery in accordance with Regulation .08 of this chapter. #### Regulation .07 Payment Procedures. *COMAR 10.18.07.07* A. A recipient, recipient’s representative, health care provider, insurer, employer, or health plan administrator, as applicable: (1) May request payment costs allowed under this chapter on behalf of the recipient according to procedures established by the Department; (2) Shall submit a payment request that is: (a) An invoice for the recipient’s health or prescription drug plan insurance premium, copays, coinsurance, and deductibles for core medical services issued by an insurer, an employer, a health plan administrator, prescription drug plan administrator, or a health care provider; and (b) Submitted timely to allow for payment in accordance with §§A(3) and B(4) of this regulation; and (3) Shall make the initial request for the payment of costs within the time frames established by the health or prescription drug insurance policy. B. The Department: (1) Shall process a payment request as required by this chapter; (2) Shall inform a recipient or the recipient’s representative if an invoice is not paid; (3) Shall make payments in accordance with any applicable policies and procedures for the administration of federal funds issued pursuant to the Ryan White CARE Act Amendments of 1996, P. L. 104—146, and any subsequent modifications to the Act; and (4) Shall make subsequent payments: (a) As permitted under a health or prescription drug plan; or (b) Upon agreement between the Department and the: (i) Insurer; (ii) Employer; (iii) Health plan administrator; (iv) Prescription drug plan administrator; or (v) Health care provider. #### Regulation .08 Recovery of Payments. *COMAR 10.18.07.08* If MADAP-Plus payments have been incorrectly paid or another payer has been identified, the Department shall seek recovery of the amount of those payments. #### Regulation .09 Fraud. *COMAR 10.18.07.09* The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision. #### Regulation .10 Confidentiality. *COMAR 10.18.07.10* Unless otherwise authorized by law, the Department: A. Shall keep all applicant and recipient personal information confidential; B. May not disclose personal information kept on an applicant or recipient without the written consent of the: (1) Applicant; (2) Recipient; (3) Applicant’s parent or legal guardian; or (4) Recipient’s parent or legal guardian; C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under: (1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C; §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations. #### Regulation .11 Availability of Funding and Program Termination. *COMAR 10.18.07.11* A. If sufficient monies are not available to fund MADAP-Plus, the Department shall take the action necessary to eliminate a deficit which may include MADAP-Plus termination. B. If MADAP-Plus is terminated, the Department shall provide coverage for each current recipient until the earlier of: (1) The date on which the next verification of eligibility is due to be submitted to the Department; or (2) Six months from the date MADAP-Plus is terminated. ### Chapter 08 — HIV Testing Procedures **Authority:** Criminal Procedure Article, §§11-107—11-117; Health-General Article, §§2-104(b) and(i), 2-105(a) and (b),18-102, 18-201.1, 18-202.1, 18-205, 18-207, 18-208, 18-334, 18-336—18-338, 18-338.2, 18-338.3, and 20-102; Annotated Code of Maryland **Administrative History:** Effective date: February 3, 2003 (30:2 Md. R. 76) **Administrative History:** Regulation .01A amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .01F adopted effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .02B amended effective September 8, 2008 (35:18 Md. R. 1600); December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .03 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .04 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .05 amended effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .06 amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .06B amended effective September 8, 2008 (35:18 Md. R. 1600) **Administrative History:** Regulation .07 amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .08 amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .10A, C amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .11 adopted effective June 11, 2012 (39:11 Md. R. 687) **Administrative History:** Regulation .12 adopted effective June 11, 2012 (39:11 Md. R. 687) **Administrative History:** Chapter revised effective March 28, 2016 (43:6 Md. R. 408) **Administrative History:** Chapter revised effective May 7, 2018 (45:9 Md. R. 462) #### Regulation .01 Scope. *COMAR 10.18.08.01* A. Except as provided in §§C—F of this regulation, this chapter governs: (1) Pretest and post-test information; (2) Requirements for reporting and control efforts; (3) Requirements for informed consent; and (4) Specific counseling for patients, including when HIV testing is performed on pregnant women as part of a prenatal care program. B. In cases exempt from the requirements for consent throughout this chapter, as specified in §§C—F of this regulation, it is not necessary to obtain written informed consent for HIV testing on the form approved by the Secretary. C. If an HIV test is performed on an individual solely for the purpose of determining the suitability of that individual as a prospective donor of blood, semen, or tissue, the requirements for information and consent are addressed in: (1) Health-General Article, §18-334, Annotated Code of Maryland; and (2) COMAR 10.50.01. D. If an HIV test is performed on an individual as a result of a court order issued under the provisions of the Criminal Procedure Article, §§11-107—11-117, Annotated Code of Maryland: (1) The requirements for HIV testing are addressed in COMAR 10.52.10; and (2) Informed consent does not apply. E. HIV testing undertaken under provisions of Health-General Article, §§18-338, 18-338.1, and 18-338.3, Annotated Code of Maryland, is not governed by this chapter. F. HIV testing of specimens for research is not governed by this chapter if: (1) All personal identifiers have been removed from the specimen; (2) The specimen cannot be linked to the patient from whom the specimen was taken; (3) The test result cannot be linked to the patient from whom the specimen was taken; and (4) The research protocol has been approved by an institutional review board. G. This chapter pertains to all patients for whom a diagnostic test for the presence of HIV infection is conducted, including minors and pregnant women receiving prenatal care. #### Regulation .02 Definitions. *COMAR 10.18.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus. (2) “Anonymous” means that: (a) A patient’s name is not used for identification; and (b) The patient can be identified only through use of an assigned code. (3) “Applicant” means a community based organization or other similar agency that seeks approval to become a designated human immunodeficiency virus testing site. (4) “Appropriate entity” means the Maryland Department of Health or the Baltimore City Health Department, which designate HIV testing sites in the State per Regulations .03 and .04 of this chapter. (5) “Centers for Disease Control and Prevention (CDC)” means the federal Centers for Disease Control and Prevention of the federal Department of Health and Human Services. (6) “Confidential” means that a patient’s name is used as identification and that the patient’s medical records contain the patient’s name but are protected against disclosure as provided by statute. (7) “Counseling” means providing education to pregnant women on: (a) The effect of a positive HIV test result on the pregnant woman and fetus concerning the risk of transmission of HIV to the fetus; and (b) Recognized methods of reducing the risk of transmission of HIV to the fetus during pregnancy. (8) “Department” means the Maryland Department of Health. (9) “Designated anonymous testing site” means a human immunodeficiency virus testing site approved by the Department or the Baltimore City Health Department as a site where a patient may have an anonymous human immunodeficiency virus test using a code rather than a name for identification. (10) “Health care facility” means a facility or office where health or medical care is provided to patients by a health care provider including: (a) A hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland; (b) A freestanding medical facility as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland; (c) A health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland; (d) The Department of Public Safety and Correctional Services; (e) A program approved by the Department to provide human immunodeficiency virus testing services, according to Regulations .03 and .04 of this chapter; (f) A facility operated by the Department or a local health officer; or (g) The office of a health care provider. (11) “Health care provider” means a: (a) Physician; (b) Nurse; (c) Licensed direct-entry midwife; or (d) Designee of a health care facility. (12) “Human immunodeficiency virus (HIV)” means a virus that causes AIDS. (13) “Indeterminate HIV test result” means that a test did not establish either the presence or absence of HIV infection as defined by the CDC’s laboratory criteria. (14) “Informed consent” means the voluntary permission by the patient to be tested for HIV, after the patient receives pretest information as specified in Regulations .06 and .08 of this chapter. (15) “Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR 46, to review the use of human subjects in proposed research. (16) “Negative HIV test result” means the test result failed to document the presence of HIV as defined by the CDC’s laboratory criteria. (17) Nonclinical Settings. (a) “Nonclinical settings” means locations: (i) That are not health care settings; (ii) Where medical or treatment services are not provided; and (iii) Where selected diagnostic services and selected prevention services may be provided. (b) “Nonclinical settings” may include: (i) Community based organizations; (ii) Outreach settings; or (iii) Mobile vans. (18) Partner. (a) “Partner” means an individual with whom one has: (i) Had or will have, oral, anal, or vaginal sexual contact; or (ii) Shared hypodermic needles or other similar drug paraphernalia. (b) “Partner” includes any individual who: (i) Is the marriage partner of an HIV-infected patient; or (ii) Has been the marriage partner of the HIV-infected patient at any time within the 10-year period before the diagnosis of HIV infection. (19) “Patient” means any individual who has presented for an HIV test, whether or not the individual chooses to be tested for HIV. (20) “Positive HIV test result” means the test result has documented the presence of HIV as defined by the CDC’s laboratory criteria. (21) “Post-test information” means notifying a patient about HIV test results and providing a patient with other relevant information after an HIV test has been performed, as required by Regulations .09 and .10 of this chapter. (22) “Prenatal care” means obstetric and gynecologic services performed as part of a medical care program for a pregnant woman and her unborn child, and may include: (a) Screening; (b) Physical examination; (c) Laboratory and diagnostic testing procedures and interpretation; or (d) Counseling. (23) “Pretest information” means providing a patient with information before a specimen is tested for the presence of HIV infection, as required by Regulations .06 and .08 of this chapter. (24) “Research” means an investigation carried out according to a protocol approved by an institutional review board. (25) “Secretary” means the Secretary of Health. (26) “Seropositive” means that a positive HIV test result has been obtained from the test of a patient’s specimen. (27) “Specimen” means a sample of: (a) Blood; (b) Other body fluid; or (c) Body tissue. (28) “Surrogate consent” means consent given by an individual who is not the patient, as permitted under Health-General Article, §5-605, Annotated Code of Maryland, and other provisions of Maryland law. #### Regulation .03 Requirements for Designated Anonymous Testing Sites. *COMAR 10.18.08.03* A. An applicant shall seek approval from an appropriate entity to become a designated anonymous testing site from the: (1) Baltimore City Health Department for an applicant offering services in Baltimore City; or (2) Department for an applicant offering services outside of Baltimore City. B. An applicant that seeks approval to become a designated anonymous testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity. C. The Department or the Baltimore City Health Department shall: (1) Review a written request that is submitted for approval; and (2) Respond in writing to the written request: (a) Indicating approval or disapproval to become a designated anonymous testing site; or (b) Soliciting for revision and resubmission of the written request. #### Regulation .04 Requirements for Designated Confidential Testing Sites. *COMAR 10.18.08.04* A. An applicant shall seek approval from an appropriate entity to become a designated confidential testing site from the: (1) Baltimore City Health Department for an applicant offering services in Baltimore City; or (2) Department for an applicant offering services outside of Baltimore City. B. An applicant that seeks approval to become a designated confidential testing site shall request an application from the appropriate entity and submit a completed application in writing to the appropriate entity. C. The Department or the Baltimore City Health Department shall: (1) Review a written request that is submitted for approval; and (2) Respond in writing to the written request: (a) Indicating approval or disapproval to become a designated confidential testing site; or (b) Soliciting for revision and resubmission of the written request. #### Regulation .05 Denial and Reconsideration. *COMAR 10.18.08.05* A. An applicant under Regulation .03 or .04 of this chapter that has a written request denied by the appropriate entity may request reconsideration of the decision: (1) By submitting the request in writing to the appropriate entity; and (2) Within 30 calendar days of the date on the notice of denial. B. If an applicant requests a reconsideration according to §A of this regulation, the appropriate entity shall: (1) Review the request for reconsideration and any supplemental documentation submitted by the applicant within 45 calendar days of the date on the letter requesting reconsideration; and (2) Issue a decision in writing to the applicant. #### Regulation .06 Consent and Pretest Requirements for HIV Testing by Health Care Providers. *COMAR 10.18.08.06* A. General medical consent is sufficient to perform HIV testing. B. Consent for HIV testing is only required to be obtained one time during a patient’s visit. C. A health care provider who obtains consent for HIV testing shall: (1) Obtain consent as a part of a patient’s general consent for medical care in the same manner as for other screening and diagnostic tests; (2) Document all declinations of an HIV test in the medical record of the patient; and (3) When needed, obtain: (a) Consent from a health care agent designated per Health-General Article, §5-602, Annotated Code of Maryland; or (b) Surrogate consent per Health-General Article, §5-605 Annotated Code of Maryland. D. The general informed consent form for medical care may specify that an HIV test will be performed. E. Except as provided under Regulation .08 of this chapter, a health care provider may not be required to obtain consent for HIV testing on a separate consent form. F. Pretest information, including counseling for pregnant women, shall be provided to the patient to be tested for HIV before each specimen is tested. G. A health care provider providing pretest information, including counseling for pregnant women, shall: (1) Provide HIV-specific information: (a) Verbally; (b) In writing; (c) Through video; or (d) Through any combination of §G(1)(a)—(c) of this regulation; (2) Provide HIV information in a manner that protects the confidentiality of the patient being tested; (3) Using layman’s terms, provide, at minimum, the following information to the patient being tested: (a) That the patient is being tested for HIV; (b) That the patient has the right to: (i) Ask questions; and (ii) Decline the test without penalty; (c) An explanation of HIV infection; (d) That a negative HIV test result means that: (i) A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and (ii) If the patient has had any potential recent exposures, the patient should be retested within an appropriate time frame based on the type of testing used; and (e) That a positive HIV test result means the patient: (i) Is infected with HIV; and (ii) Will be linked with medical treatment and other supportive services; (4) Provide counseling as defined in Regulation .02 of this chapter to pregnant women; (5) Include an opportunity for the patient to: (a) Ask questions and receive answers about HIV and other topics described in this regulation; and (b) Decline an HIV test; and (6) Make necessary accommodation with respect to language or disability to ensure that the patient being tested understands the information presented. #### Regulation .07 Testing Requirements for Pregnant Women Receiving Prenatal Care. *COMAR 10.18.08.07* A. As part of a health care provider’s patient acceptance procedures or protocol, a health care provider shall give a pregnant woman information on being tested for the presence of HIV as part of the woman’s prenatal care program. B. In addition to §§C—E of this regulation, a health care provider testing a pregnant woman shall follow all requirements for pretest and post-test information as set forth in Regulations .06 and .08—.10 of this chapter as appropriate. C. Unless a patient declines, a health care provider shall test a pregnant woman under the health care provider’s care: (1) During the first trimester of pregnancy or the first prenatal visit; and (2) In the third trimester of pregnancy. D. A health care provider who provides labor and delivery services to a pregnant woman shall offer: (1) A rapid HIV test to a pregnant woman with unknown or undocumented HIV status during labor and delivery; and (2) Antiretroviral prophylaxis before receiving the results of the confirmatory test if a rapid HIV test performed during labor and delivery is positive. E. Confidentiality. (1) HIV test results for pregnant women shall be maintained pursuant to Health-General Article, §18-338.2, Annotated Code of Maryland. (2) Except as otherwise provided in §E(3) of this regulation, the record of an HIV test performed under this section is confidential and not discoverable or admissible in evidence in any criminal, civil, or administrative action. (3) Provided that the identity or any other information that could readily be associated with the identity of the pregnant woman is not disclosed, the results of an HIV test performed under this section may be introduced into evidence in a criminal, civil, or administrative action, including the adjudication of a workers’ compensation claim. #### Regulation .08 Consent and Pretest Requirements for HIV Testing in Nonclinical Settings. *COMAR 10.18.08.08* A. For HIV tests administered in nonclinical settings, as permitted in Regulations .03 and .04 of this chapter, the individual administering the HIV test shall: (1) Utilize the HIV informed consent form approved by the Secretary to document the obtainment of informed consent; (2) Read and explain the HIV informed consent form, through an interpreter if necessary, to anyone who cannot read or understand the form’s contents; and (3) Obtain voluntary written informed consent from the patient before an HIV test is performed on a specimen. B. A patient tested at a designated anonymous nonclinical test site, as permitted in Regulation .03 of this chapter, may indicate consent by placing their assigned code on the signature line of the form approved by the Secretary to indicate written informed consent. C. Pretest information shall be provided to the patient being tested before each specimen is tested. D. An individual providing pretest information shall: (1) Provide HIV-specific information: (a) Verbally; (b) In writing; (c) Through video; or (d) Through any combination of §D(1)(a)—(c) of this regulation based on the testing history and information needs of the patient; (2) Provide HIV information in a manner that protects the confidentiality of the patient; (3) Using layman’s terms, provide, at a minimum, the following information to the patient: (a) That the patient is being tested for HIV; (b) That the patient has the right to: (i) Ask questions; and (ii) Decline the test without penalty; (c) The primary modes of HIV transmission including: (i) Sexual contact without the use of condoms, other barriers, or other biomedical interventions; (ii) Injection drug use; and (iii) Mother-to-child transmission; (d) Counseling as defined in Regulation .02 of this chapter to pregnant women; (e) That a negative test result means that: (i) A patient is not infected with HIV or that the test was unable to detect the presence of HIV because a patient is in the early stage of infection and has not yet developed detectable evidence of HIV infection; and (ii) If the patient has had any potential recent exposures, that the patient should be retested within an appropriate time frame based on the type of testing used; (f) That a positive test result means the patient: (i) Is infected with HIV; (ii) Will be linked with medical treatment and other supportive services; and (iii) May need a confirmatory test if the preliminary positive was based on an HIV rapid test; and (g) Inform the patient being tested at a designated anonymous HIV test site that an assigned code will be used instead of a name; (4) Include an opportunity for the patient to: (a) Ask questions and receive answers about HIV infection and other topics described in this regulation; and (b) Decline HIV testing; and (5) Make necessary accommodation with respect to language or disability to ensure that the patient understands the information presented. #### Regulation .09 Post-Test Requirements for HIV Testing by Health Care Providers. *COMAR 10.18.08.09* A. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes: (1) That the HIV test result is negative; and (2) The meaning of a negative result. B. If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient in person that includes: (1) That the HIV test result is indeterminate; (2) The meaning of an indeterminate HIV test result; and (3) A recommendation that the patient: (a) Return in a medically appropriate time frame for another HIV test; and (b) Take precautions as if the patient’s HIV test result had been positive until the patient is retested. C. If a patient’s HIV test result is positive: (1) The individual providing testing shall provide post-test information to the patient in person that includes: (a) That the HIV test result is positive; (b) The meaning of a positive HIV test result; (c) If the patient is pregnant: (i) How HIV infection may affect a pregnancy, fetus, or newborn; (ii) That there is a potential that the newborn will have HIV infection; and (iii) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; and (d) Information regarding the patient’s responsibility to: (i) Notify all known sexual and needle-sharing partners of possible exposure; or (ii) Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure; (2) The health care provider shall: (a) Ensure the patient is linked to an appropriate source of HIV medical care and support services; and (b) If necessary, provide the patient with information about mental health services for HIV-infected individuals; (3) For contact control, the health care provider shall: (a) Endeavor to bring an individual with whom the patient has had potentially infectious contact to examination and, as appropriate, prophylaxis by: (i) Requesting the health officer to conduct a contact investigation of any case of HIV; or (ii) Interviewing the patient in order to ascertain the names, descriptions, addresses, telephone numbers, and email addresses of those with whom the patient has had potentially infectious contact; and (b) Report immediately to the health officer an individual identified as having had potentially infectious contact with a patient with a positive HIV test result; (4) A health officer shall: (a) Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and (b) Immediately forward to the Secretary all reports of individuals who are outside the health officer’s territorial jurisdiction for referral to the health officer of the proper jurisdiction; and (5) A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV. #### Regulation .10 Post-Test Requirements for HIV Testing in Nonclinical Settings. *COMAR 10.18.08.10* A. If a patient’s HIV test result is negative, the individual providing testing shall provide post-test information to the patient tested that includes: (1) That the HIV test result is negative; (2) The meaning of a negative result; and (3) A recommendation about whether a repeat test is advisable based on potential recent exposures and the type of test technology used. B. If a patient’s HIV test result is indeterminate, the individual providing testing shall provide post-test information to the patient tested in person that includes: (1) That the HIV test result is indeterminate; (2) The meaning of an indeterminate HIV test result; (3) Information regarding transmission of HIV and means of preventing transmission of HIV; and (4) A recommendation that the patient: (a) Return in a medically appropriate time frame for another HIV test; and (b) Take precautions as if the patient’s HIV test result had been positive until the patient is retested. C. If a patient’s HIV test result is positive: (1) The individual providing testing shall provide post-test information to the patient tested in person that includes: (a) That the HIV test result is positive; (b) The meaning of a positive HIV test result; (c) Information regarding transmission of HIV and means of preventing transmission of HIV; (d) If the patient is pregnant; (i) How HIV infection may affect a pregnancy, fetus, or newborn; (ii) That there is a potential that the newborn would have HIV infection; and (iii) Information regarding recognized methods of reducing the risk of transmission of HIV to the fetus; (e) That the patient should have a medical evaluation by a physician or physician’s designee who knows that the patient is HIV positive; (f) That the patient should receive ongoing health care appropriate for an HIV seropositive individual; and (g) Information regarding the patient’s responsibility to: (i) Notify all known sexual and needle-sharing partners of possible exposure; or (ii) Request assistance from the health officer in the jurisdiction to notify all known sexual and needle-sharing partners of possible exposure; (2) The individual performing the HIV test shall: (a) Ensure the patient is linked to an appropriate source of HIV medical care and support services including evaluation and treatment for: (i) Tuberculosis; (ii) Hepatitis; (iii) Pregnancy; and (iv) Sexually transmitted infections; and (b) If necessary, provide the patient with information about mental health services for HIV-infected individuals; (3) For contact control, the individual providing the testing shall: (a) Request the health officer from the patient’s home jurisdiction conduct a contact investigation of any case of HIV; and (b) Report immediately to the health officer from the patient’s home jurisdiction any known individual identified as having had potentially infectious contact with a patient with a positive HIV test result; (4) A health officer shall: (a) Investigate and notify immediately an individual reported under the provisions of §C(3)(b) of this regulation, who is within the health officer’s jurisdiction, of the individual’s exposure and advise the individual to undergo a medical examination to ascertain whether the individual is infected with HIV; and (b) Immediately forward to the Secretary all reports of individuals who are outside the health officer’s jurisdiction for referral to the health officer of the proper jurisdiction; and (5) A reported individual shall, within 1 week of notification, be examined to ascertain whether the individual has been infected with HIV. #### Regulation .11 Immunity for Health Care Providers Working with Pregnant Women. *COMAR 10.18.08.11* A health care provider may not be subject to disciplinary action by the professional licensing board that licenses the health care provider for following the requirements for prenatal HIV testing established by the Department. #### Regulation .12 Health Care Providers, First Responders, and Public Safety Workers — HIV Exposure. *COMAR 10.18.08.12* A. Definition. (1) In this regulation, the following term has the meaning indicated. (2) “Infection preventionist or employee health provider” means the designated infectious disease/communicable disease officer of a hospital. B. A health care provider, first responder, or public safety worker involved in an exposure as defined in Health-General Article, §18-338.3, Annotated Code of Maryland, shall comply with the provisions of Health-General Article, §18-338.3, Annotated Code of Maryland. C. A hospital’s designated infection preventionist or employee health provider or its designee shall follow the requirements in Health-General Article, §18-338.3, Annotated Code of Maryland, if an exposure, as defined in Health-General Article, §18-338.3, Annotated Code of Maryland: (1) Occurs: (a) In a hospital, between a patient and a health care provider; or (b) Before admission of the patient to a hospital, between a patient and a: (i) First responder; or (ii) Public safety worker; and (2) Is such that, in accordance with the CDC’s recommendations, warrants recommending or offering chemoprophylaxis treatment for the health care provider, first responder, or public safety worker. #### Regulation .13 Information on Exposures. *COMAR 10.18.08.13* A. A hospital where an exposure occurred shall: (1) Maintain a confidential record or incident report for an HIV test conducted under Regulation .12 of this chapter; (2) Adopt procedures for the confidential HIV testing of blood samples or other body fluids used or collected for purposes of Regulation .12 of this chapter; (3) Maintain a record of: (a) An exposure as defined by Health-General Article, §18-338.3(a), Annotated Code of Maryland; and (b) A refusal to consent by a patient as described in the Health-General Article, §18-338.3(b)(2)(ii), Annotated Code of Maryland; and (4) Provide records as specified in §A(3)of this regulation or information from the records to the Department when and as requested by the Secretary. B. Nothing in Regulation .12 of this chapter or this regulation shall be construed to exempt any individual or entity required to report infectious diseases from reporting the infectious diseases as required in Health-General Article, Title 18, Annotated Code of Maryland. ### Chapter 09 — HIV Testing for Pregnant Women Receiving Prenatal Care *Repealed* **Administrative History:** Effective date: August 28, 2006 (33:17 Md. R. 1437) **Administrative History:** Regulation .01A amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .01F adopted effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .02B amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .03 amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .04 amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .05 amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Regulation .07B amended effective December 14, 2009 (36:25 Md. R. 1954) **Administrative History:** Chapter revised effective March 27, 2017 (44:6 Md. R. 326) **Administrative History:** Chapter repealed effective May 7, 2018 (45:9 Md. R. 462) ### Chapter 10 — Urgent Maryland AIDS Drug Assistance Program *Repealed* **Administrative History:** Effective date: March 28, 2016 (43:6 Md. R. 408) **Administrative History:** Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .03B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .04 amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .05B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulations .01—.09 repealed effective June 13, 2022 (49:12 Md. R. 640) ## Subtitle 19 — Dangerous Devices and Substances ### Chapter 01 — Prohibition of Bisphenol-A in Child Care Articles **Authority:** Health-General Article, §24-304, Annotated Code of Maryland **Administrative History:** Effective date: November 28, 2011 (38:24 Md. R. 1502) #### Regulation .01 Scope. *COMAR 10.19.01.01* This chapter establishes regulations that prohibit the manufacturing, sale, or distribution of child care articles that contain bisphenol-A, also known as BPA. #### Regulation .02 Definitions. *COMAR 10.19.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Bisphenol-A (BPA)” means an industrial chemical also known as 2,2-bis (4-hydroxyphenyl) propane used primarily in the manufacture of polycarbonate plastic and epoxy resins. (2) “Child care article” means an empty bottle or cup to be filled with food or liquid that is designed or intended by a manufacturer to be used by a child younger than 4 years old. #### Regulation .03 Prohibition of Bisphenol-A in Child Care Articles. *COMAR 10.19.01.03* On or after January 1, 2012, a person may not manufacture, knowingly sell, or distribute in commerce a child care article containing bisphenol-A. #### Regulation .04 Requirements on Manufacturers. *COMAR 10.19.01.04* A. A manufacturer of a child care article shall use a safe and legal alternative to BPA when replacing BPA in a child care article. B. A manufacturer of a child care article may not use in place of BPA a substance determined by the United States Environmental Protection Agency to be a: (1) Group A, B, or C carcinogen; or (2) Reproductive toxicant causing birth defect, reproductive harm, or developmental harm. #### Regulation .05 Violations. *COMAR 10.19.01.05* A person that violates any of the provisions of Health-General Article, §24-304, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $10,000 for each violation. ### Chapter 02 — Hazardous Substances **Authority:** Health-General Article, §22-502, Annotated Code of Maryland **Administrative History:** Effective date: February 2, 1977 (4:3 Md. R. 145) #### Regulation .01 Incorporation by Reference. *COMAR 10.19.02.01* A. All provisions of 16 Code of Federal Regulations, Parts 1500 and 1505, are incorporated by reference, with the following changes set forth below. B. 1500.3 Definitions. (1) “Act” means the Maryland Hazardous Substance Act, Health-General Article, §22-502, Annotated Code of Maryland. (2) “Commission” means the Maryland Department of Health. ### Chapter 03 — Controlled Dangerous Substances **Authority:** Criminal Law Article, Title 5; Health-General Article, §21-220; Annotated Code of Maryland **Administrative History:** Effective date: January 19, 1977 (4:2 Md. R. 87) **Administrative History:** Regulation .03A amended effective December 17, 1984 (11:25 Md. R. 2134); February 17, 1992 (19:3 Md. R. 304); December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .07E and J amended effective August 17, 1992 (19:16 Md. R. 1474) **Administrative History:** Regulation .07H amended effective July 12, 1998 (25:14 Md. R. 1132) **Administrative History:** Regulations .07N, R and .10B amended effective February 10, 1978 (5:3 Md. R. 138) **Administrative History:** Regulation .08G amended effective March 30, 1992 (19:6 Md. R. 673) **Administrative History:** Regulation .09A amended effective April 18, 1980 (7:8 Md. R. 771) **Administrative History:** Chapter revised effective April 26, 2004 (31:8 Md. R. 646) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective April 24, 2006 (33:8 Md. R. 732) **Administrative History:** Regulation .03 amended effective January 1, 2016 (42:22 Md. R. 1377) **Administrative History:** Regulation .13 adopted as an emergency provision effective October 18, 2011 (38:24 Md. R. 1495); adopted permanently effective December 26, 2011 (38:26 Md. R. 1697) **Administrative History:** Regulations .01—.13 repealed and new Regulations .01—.20 adopted effective October 14, 2024 (51:20 Md. R. 899) #### Regulation .01 Scope and Purpose. *COMAR 10.19.03.01* A. The Secretary of the Maryland Department of Health recognizes that the public interest requires control over the use of controlled substances in the legitimate manufacturing, distributing, dispensing, storing, and ordering of controlled substances. B. This chapter applies to every registrant who manufactures, distributes, dispenses, stores, and orders any controlled substances within the State of Maryland, unless exempted from registration by Criminal Law Article, §5-301(d), Annotated Code of Maryland, or 21 CFR §§1301.22 — 1301.24. C. In the event of conflict between a provision of the Code of Federal Regulations referenced under a provision of this chapter and the provision of this chapter, the registrant shall comply with the more stringent provision. #### Regulation .02 Incorporation by Reference. *COMAR 10.19.03.02* In this chapter, 21 CFR §§1300 —1317, as amended, are incorporated by reference. #### Regulation .03 Definitions. *COMAR 10.19.03.03* A. Applicability to Chapter. In this chapter, the terms defined in §B of this regulation have the meanings indicated. In addition, and unless otherwise provided in this chapter, the definitions appearing in Criminal Law Article, §5-101, Annotated Code of Maryland, shall also apply to this chapter. B. Terms Defined. (1) “Act” means the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-101—5-1101, Annotated Code of Maryland. (2) “Administrative probable cause” means a valid public interest, sufficient to justify an administrative warrant, allowing the inspection of the area, premises, or building to enforce this chapter. (3) “Agent” means a person who acts on behalf of the Department. (4) “Authorized provider” or “provider” means a: (a) Person licensed, registered, or otherwise allowed to dispense, order, and store controlled substances; (b) Pharmacy, laboratory, hospital, or other institution licensed, registered, or otherwise allowed to manufacture, distribute, dispense, store, and order controlled substances; or (c) Person licensed, registered, or otherwise allowed to conduct research on a controlled substance in the State in the course of professional practice or research. (5) “Board” means the Maryland Boards of Physicians, Podiatry, Dental Examiners, Nursing, and Veterinary Medicine. (6) “Chemical analysis” means the act of decomposing a substance into its constituent elements. (7) “Civil fine” means a fine assessed by the Department against an authorized provider, including establishments. (8) Commercial Container. (a) “Commercial container” means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user. (b) “Commercial container” includes any box or package in which a receptacle is held for distribution or dispensing to an ultimate user. (c) “Commercial container” does not include any package liner, package insert, or other material kept with or within a commercial container, or any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances. (9) Controlled Premises. (a) “Controlled premises” means places where original or other records or documents required under the Act are kept or required to be kept. (b) “Controlled premises” includes factories, warehouses, other establishments, and conveyances, where persons registered under the Act or exempt from registration under the Act may lawfully hold, manufacture, distribute, dispense, administer, or otherwise dispose of controlled substances. (10) “Department” means the Maryland Department of Health. (11) “Disciplinary action” includes but is not limited to a penalty, reprimand, restriction, suspension, or revocation of a license. (12) “Federal Act” means the Controlled Substance Act (84 Stat. 1242; 21 U.S.C. 801) or the Controlled Substance Import and Export Act (84 Stat. 1285; 21 U.S.C. 951). (13) “Fee exempt” means an authorized provider that is required to register with the Department but is not required to pay the registration fee. (14) “In good standing” means having a professional license that is not subject to any form of sanction by the Board or Criminal Law. (15) “Inspector” means an officer or employee of the Department authorized by the Secretary to make inspections under the Act. (16) “Labeling” means all labels and other written, printed, or graphic matter on any controlled substance or any of its commercial containers or wrappers accompanying controlled substances. (17) “License” has the same meaning as State Government Article, §10-226, Annotated Code of Maryland. (18) Manufacture. (a) “Manufacture” means: (i) Producing, preparation, propagation, compounding, or processing of a drug or other substance; (ii) Packaging or repackaging of the substance; or (iii) Labeling or re-labeling of the commercial container of the substance. (b) “Manufacture” does not include the activities of a provider who, as an incident to the provider’s administration or dispensing the substance in the course of the provider’s professional practice, prepares, compounds, packages, or labels the substance. (19) “Manufacturer” means a person who manufactures a drug or other substance under: (a) A registration as a manufacturer; or (b) Authority of registration as a researcher or chemical analyst. (20) “Office of Controlled Substances Administration (OCSA)” refers to the division within the Maryland Department of Health responsible for administering the enforcement of Criminal Law Article, Title 5, Annotated Code of Maryland. (21) “Penalty” means monetary penalty, including but not limited to a fine. (22) “Person” means: (a) An authorized provider; (b) The responsible party listed on the application licensed by the DEA; or (c) The responsible party listed on the application for an establishment not licensed by the DEA. (23) “Peyote” means the controlled substance in Schedule I under Criminal Law Article, §5-402, Annotated Code of Maryland. This schedule I listing does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church using peyote in this manner are exempt from registration. (24) “Pharmacist” means: (a) A pharmacist licensed in the State or otherwise authorized to dispense controlled substances; or (b) An individual, for example, a pharmacist intern, authorized by a state to dispense controlled substances under the supervision of a pharmacist licensed by that state. (25) Prescription. (a) “Prescription” means an order for medication that is dispensed to or for an ultimate user. (b) “Prescription” does not include an order for medication which is dispensed for immediate administration to the ultimate user, such as an order to dispense a drug to a bed patient for immediate administration in a hospital. (26) “Registration” means initial registration or subsequent re-registration with OCSA. (27) “Secretary” means the Secretary of the Maryland Department of Health. (28) “Sufficient application” means an application that is completed in full and has provided all of the information required by the Department. #### Regulation .04 Registration: Requirements and Qualifications. *COMAR 10.19.03.04* A. Except for military and federal employees working within the scope of federal employment, a person shall register with the Department and obtain a registration certificate before the person: (1) Manufactures, distributes, dispenses, stores, and orders controlled substances; (2) Conducts research or instructional activities with controlled substances listed in Schedules II through V of Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland; (3) Conducts research or instructional activities with a controlled substance listed in Schedule I of Criminal Law Article, §5-402, Annotated Code of Maryland, with prior registration from the DEA; (4) Conducts a chemical analysis with controlled substances listed in any schedule; (5) Installs and maintains an automated dispensing machine containing controlled substances; or (6) Manufactures peyote for, or distributes peyote to, the Native American Church for bona fide religious ceremonies of the Native American Church. B. An authorized provider shall: (1) Apply for a registration certificate on a form made available by the Department to: (a) Obtain one registration for all locations that a provider prescribes only and no controlled substances are stored; or (b) Obtain a single registration for each separate location where the provider prescribes, dispenses, orders, and stores controlled substances; (2) Have a professional license in good standing; (3) Be of good moral character; (4) Have no convictions for crimes of moral turpitude; (5) Be 18 years of age or older; (6) Be registered with the Prescription Drug Monitoring Program if the authorized provider is also a prescriber as defined under Health-General Article, §21-2A-04.1, Annotated Code of Maryland; and (7) Except for researchers, have completed 2 continuing education credit hours: (a) Prior to applying for an initial controlled substance registration occurring on or after October 1, 2018; or (b) Prior to the first renewal of a controlled substance registration occurring on or after October 1, 2018. C. Continuing Education. (1) The continuing education shall: (a) Be accredited by the Accreditation Council for Continuing Medical Education; or (b) Meet the requirements for approval by the authorized providers professional board. (2) The continuing education shall pertain to the prescribing or dispensing of controlled substances. (3) Authorized providers shall meet the requirements of §§B and C of this regulation upon the completion of the 2 credit hours of continuing education. (4) Recent graduates meet the requirements of §§B and C of this regulation upon initial application if two academic course credits were issued relating to controlled substances. D. An establishment shall: (1) Apply for a registration certificate on a form made available by the Department; (2) Obtain one registration for each separate place of business, professional practice, or location where controlled substances are: (a) Ordered; (b) Purchased; (c) Administered; (d) Delivered to the ultimate user; (e) Stored; (f) Manufactured; or (g) Distributed; and (3) Have a professional or occupational license in good standing to perform any of the following functions related to controlled substances: (a) Manufacture; (b) Distribute; (c) Deliver to the ultimate user; (d) Administer; (e) Store; (f) Order; (g) Prescribe; (h) Package; (i) Label; or (j) Compound. #### Regulation .05 Registration: Application. *COMAR 10.19.03.05* A. A person shall complete an application to be considered for a registration certificate. B. The applicant shall: (1) Submit a completed application made available by the Department; (2) Except for fee exempt applicants, pay the appropriate fee as set forth in Regulation .06 of this chapter; (3) Unless exempt from payment of a registration fee, apply for and obtain a registration certificate; (4) Provide an explanation for any not-applicable responses on the applications; (5) Notify the Department of any criminal convictions related to controlled substances; (6) Notify the Department of any actions taken on the applicant’s professional license; (7) Have the application and accompanying documents required for registration signed by the: (a) Applicant, if an individual; (b) General partner, if the applicant is a partnership; or (c) Officer responsible for the applicant, if the applicant is a corporation or other entity; and (8) Provide additional documentation required by the Department pertinent to the registration, to: (a) Clarify application information; and (b) Determine if the applicant meets the requirements of this chapter. C. New applications that are unable to be processed 6 months from the payment deposit date: (1) May be determined invalid; (2) Will not be issued a refund, unless: (a) The payment is a duplicate; or (b) Approved by the Department; and (3) Will require a new application to be resubmitted. D. Renewal applications that are unable to be processed 45 days from the payment deposit date: (1) May be determined invalid; (2) Will not be issued a refund, unless: (a) The payment is a duplicate; or (b) Approved by the Department; and (3) Will require a new renewal application to be submitted. #### Regulation .06 Registration: Fees. *COMAR 10.19.03.06* A. An authorized provider or establishment required to obtain and maintain a registration certificate as set forth under this chapter shall pay the appropriate fees as follows: (1) New registration certificate — $120; (2) Renewal registration certificate — $120; (3) Amend a registration certificate — $50; (4) Change of ownership fee — $144; (5) Duplicate registration certificate — $30; and (6) Reinstatement — $50.00. B. Applicants exempt from registration fees include: (1) Except for contractual positions, an employee of a hospital, clinic, institution, facility, or unit operated by a local or State government agency; (2) An agency, excluding a State agency and its employees, for which the State is responsible for payment of the fee, provided that the exemption is approved by the Secretary; or (3) A person included in 21 CFR §§1301.21. C. Refunds and Credits. (1) The Secretary may not issue a credit towards or refund any registration fees to an applicant, including but not limited to, an applicant who: (a) Withdraws a registration application; (b) Voluntarily or involuntarily ceases to manufacture, distribute, dispense, order, and store a controlled substances before a registration certificate expires; or (c) Does not complete the application as set forth in Regulation .05 of this chapter. (2) The Secretary, or the Secretary’s designee, shall review the refund request and determine if a refund of any amount is appropriate. D. A registrant who has lost a registration certificate is required to pay a duplicate registration fee as set forth in §A of this regulation. E. The Department may not issue a new or a renewed registration certificate until all required fees are paid. F. The Department-issued registration certificate shall be readily available to any agent or representative of the Secretary within the registered location. #### Regulation .07 Registration: Term, Expiration, Renewal, and Reinstatement. *COMAR 10.19.03.07* A. Term. The Secretary may issue a registration certificate that is valid for not more than 3 years. B. Expiration. (1) A registration certificate expires on the date shown on the certificate. (2) The Secretary shall notify the registrant that the registration will expire not less than 30 days before the expiration date shown on the certificate. C. Renewal. (1) A registration for which a sufficient application for renewal was submitted: (a) Shall be received at least 2 weeks before the expiration; and (b) Will remain in effect until the Department takes a final action. (2) The failure to receive a renewal notice does not excuse a registrant from complying with this chapter. D. Reinstatement. (1) A registrant whose registration has been surrendered in lieu of further investigation, revoked, suspended, or limited may not be eligible to request reinstatement for a: (a) 2-year period; (b) Specified period designated in a consent order from the Department; or (c) Specified time period determined by the Department. (2) To apply for reinstatement, a registrant shall: (a) Complete and submit an application on a form provided by the Department; and (b) Pay a reinstatement fee shown in Regulation .06 of this chapter. #### Regulation .08 Registration Certificate: Assignment, Transfer, or Termination. *COMAR 10.19.03.08* A. A registration certificate is not transferable. B. A registration certificate becomes void when the registrant: (1) Dies; (2) Discontinues business or professional practice in the State; or (3) Changes ownership, including when: (a) Partners are added or deleted from the partnership; (b) There is a change in the president or chief executive officer of the corporation; or (c) There is a change in the ownership of 10 percent or more of the outstanding shares in the corporation. C. A registrant who discontinues business or professional practice in the State shall: (1) Notify the Secretary in writing; (2) Surrender the registrant’s current registration certificate; and (3) Legally transfer or dispose of any controlled substances relative to the registrant’s operation. D. A registrant who changes ownership of the business or professional practice shall: (1) Notify the Secretary in writing at least 30 days before the change occurs; (2) Complete and submit a change of ownership application to the Department; (3) Pay the change-of-ownership fee in Regulation .06 of this chapter; (4) Surrender the registrant’s current registration certificate after the ownership change is finalized; and (5) Allow the Department to inspect the business or professional practice of the new owners. E. A registrant who changes the location of a registrant’s place of business or professional practice shall: (1) Notify the Department at least 30 days before there is a change in the location of the registrant’s place of business or professional practice; (2) Apply to amend a current registration certificate; and (3) Pay the fee to amend a certificate in Regulation .06 of this chapter. F. During the 3-year registration period, the registrant shall notify the Office of Controlled Substances Administration within 30 days of the following: (1) Any criminal convictions; (2) Any disciplinary actions taken against the registrant’s professional or occupational license; or (3) Any disciplinary actions taken against the registrant’s federal Drug Enforcement Agency registration. G. After an application for registration has been filed, the Secretary may: (1) Inspect the place of business or professional practice described in the application; and (2) Investigate the applicant to determine whether the applicant meets the requirements of this chapter. H. The registrant shall inform the Office of Controlled Substances Administration prior to any address changes. #### Regulation .09 Labeling and Packaging Requirements for Controlled Substances. *COMAR 10.19.03.09* A registrant shall comply with the provisions of 21 CFR §1302, as amended. #### Regulation .10 Records and Reports Required of Registrants. *COMAR 10.19.03.10* A. Pursuant to Criminal Law Article, §5-306, Annotated Code of Maryland, a registrant shall comply with the provisions of 21 CFR §1304, as amended. B. Inventories developed under the Federal Act dated May 1, 1971, and subsequent biennial inventory dates are acceptable for purposes of the Maryland Act. C. On the effective date a substance is added to any schedule of controlled substances pursuant to Criminal Law Article, §5-202, Annotated Code of Maryland, registrants required to keep records, who possess that substance, shall take an inventory of all stocks of that substance on hand. Thereafter, that substance shall be included in each inventory made by the registrant. D. Reports required in this section shall be accessible to the representative of the Secretary. #### Regulation .11 Order Forms. *COMAR 10.19.03.11* A registrant shall comply with the provisions of 21 CFR 1305, as amended. #### Regulation .12 Prescriptions. *COMAR 10.19.03.12* A. Persons Entitled to Issue Prescriptions. (1) A prescription for a controlled substance may be issued only by an authorized provider who is: (a) Authorized to prescribe controlled substances in the State of Maryland; and (b) Either registered or exempted from registration pursuant to 21 CFR §1301.22(c) and 21 CFR §1301.23. (2) A prescription issued by an authorized provider may be communicated to a pharmacist by an employee or agent of the authorized provider. B. Purpose of Issue of Prescription. (1) A controlled substance prescription shall only be issued for a legitimate medical purpose by a provider. (2) A controlled substance prescription shall be issued by a provider in the usual course of the individual provider’s professional practice. (3) The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing provider. (4) A pharmacist has a corresponding responsibility to ensure, prior to dispensing, that a controlled substance prescription is issued for a legitimate medical purpose. (5) An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of the Maryland Controlled Dangerous Substances Act, Criminal Law Article, §§5-501—5-505, Annotated Code of Maryland. (6) A prescription may not be issued in order for an individual provider to obtain controlled substances for supplying the individual provider for the purpose of general dispensing to patients. C. A prescription for a Schedule II-V controlled substance shall be dispensed within 120 days from the date of issue. D. Unless the State has stricter requirements, if a provider has complied with 21 CFR §1306, the provider is deemed to have complied with this chapter. #### Regulation .13 Partial Fill of a Prescription. *COMAR 10.19.03.13* A partial fill of a C-II prescription is permitted if: A. The pharmacist is unable to fill the full quantity of the prescription, pursuant to 21 CFR §1306.13(a); B. The prescription is issued for a patient in a long-term care facility or for a patient with a medical diagnosis documenting a terminal illness pursuant to 21 CFR 1306.13(b) or (c); C. Requested by the patient or the practitioner that wrote the prescription, pursuant to 21 CFR §1306.13(b); or D. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. #### Regulation .14 Refilling of Prescriptions. *COMAR 10.19.03.14* A. A prescription for a controlled substance listed in Schedule II may not be refilled. B. A prescription for a controlled substance listed in Schedule III, IV, or V: (1) May not be refilled more than 6 months after the date on which the prescription was issued; (2) May not be refilled more than five times; and (3) Shall require a new and separate prescription to be issued if additional quantities are deemed necessary by the authorized prescribing provider. C. The prescribing provider may authorize additional refills of Schedule III, IV, or V substances on the original prescription through an oral refill authorization transmitted to the pharmacist if the following conditions are met: (1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills or extend beyond 6 months from the date of issue of the original prescription; (2) The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, and number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription; (3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription; and (4) The prescribing practitioner executes a new and separate prescription for any additional quantities beyond the five-refill, 6-month limitation. D. Required Documentation. (1) Each refilling of a prescription shall be documented on the: (a) Back of the prescription; (b) With Department approval, on another appropriate uniformly maintained, readily retrievable record, such as medication records; or (c) electronic prescription record. (2) The documentation shall indicate the: (a) Number of the prescription; (b) Name of the controlled substance; (c) Dosage form of the controlled substance; (d) Date of each refilling; (e) Quantity dispensed; (f) Identity or initials of the dispensing pharmacist in each refilling; (g) Total number of refills for that prescription; (h) Pharmacist’s initials; and (i) Date by the pharmacist as of the date of dispensing. (3) Each refilling of a prescription shall: (a) State the amount dispensed; or (b) If the amount dispensed is not specifically stated, be deemed to have been dispensed for the full face amount of the prescription. #### Regulation .15 Physical Security Controls for Registrants. *COMAR 10.19.03.15* A registrant shall comply with the provisions of 21 CFR §§1301.71—1301.77 as amended. #### Regulation .16 Controlled Substance Disposal. *COMAR 10.19.03.16* A. Any registrant in possession of legally obtained controlled substances and desiring or required to dispose of any of these substances may ask the Office of Controlled Substances Administration of the Maryland Department of Health for authority and instructions to dispose of this substance. This does not eliminate the requirement on registrants under federal regulations to report destruction of controlled dangerous substances. B. Disposal of Medical Waste. (1) A registrant in possession of legally obtained controlled substances deemed medical waste shall render the controlled substances irretrievable by disposing of: (a) Liquid waste in an approved containment unit; or (b) Non-liquid in a receptacle. (2) Two licensed personnel shall keep Waste Destruction Logbooks and maintain the record for 2 years. The Destruction Log shall be readily available upon inspection. C. Disposal for Registrants Required to Register with the DEA. (1) The Office of Controlled Substances Administration shall authorize and instruct the registrant to dispose of the controlled substance in one of the following manners, provided complete records of the disposition are maintained by the registrant: (a) By transfer to a person registered under the Act and authorized to possess the substance; (b) By destruction in the presence of an agent of the Office of Controlled Substances Administration or another authorized person; (c) By forwarding to the District Office of the Drug Enforcement Administration pursuant to the procedures of that agency; (d) By returning unused controlled substances dispensed by registered hospital pharmacies for administration to in-patients to the pharmacy for appropriate disposition; or (e) By other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons. (2) A registrant that has complied with 21 CFR §1304 is deemed to have complied with this section. (3) If a registrant is required regularly to dispose of controlled substances, the Special Agent in Charge of the Federal Drug Enforcement Administration may authorize the registrant to dispose of these substances, in accordance with 21 CFR §1307. D. Disposal for Registrants Not required to Register with the DEA. Any registrant who is registered to administer only and is in possession of legally obtained controlled substances shall: (1) List the controlled substance or substances which the registrant desires to dispose of on a drug destruction form provided by the Department; (2) Have two members of the professional staff, limited to an administrator, nurse, or pharmacist, destroy controlled drugs on premises; (3) Dispose per instructions given in §B of this regulation. (4) Forward a copy of the completed drug destruction form to the Office of Controlled Substances Administration within 10 days of destruction; and (5) Keep a copy of the drug disposal form on location for a period of 2 years. E. Abandoned controlled substances may be: (1) Destroyed in the presence of an agent of the Office of Controlled Substances Administration or another authorized person or persons; (2) Disposed of by other means that the Secretary may determine to assure that the substance does not become available to unauthorized persons; or (3) Impounded under Health-General Article, §21-1113, Annotated Code of Maryland. F. Aforementioned procedures do not preclude release of medication to discharged patients if ordered in writing by the attending physician. #### Regulation .17 Transfer of Controlled Substances. *COMAR 10.19.03.17* A. When closing business activities, a registrant shall: (1) Dispose of all controlled dangerous substances in accordance with Regulation .16 of this chapter; and (2) Return the controlled substances registration certificate to the Office of Controlled Substances Administration inspector at the time of the closing inspection. B. Change of Ownership. (1) A Change of Ownership requires the registrant to notify the Department in writing, Attention to the Office of Controlled Substances Administration. (2) The written notification shall be submitted: (a) In person; (b) By registered mail; or (c) By certified mail with a return receipt request. (3) The written notification must be received 14 days before the transfer occurs. (4) The Secretary has the authority to waive the 14-day time limitation in individual instances. (5) The written notification shall contain the following information: (a) The name; (b) The address; (c) The registration number; and (d) The authorized business activity of the: (i) Registrant-transferor discontinuing the business; and (ii) Registrant-transferee acquiring the business; (e) Whether the business activities will be: (i) Continued at the location registered by the person discontinuing business; or (ii) Moved to another location and, if so, the address of the new location; and (f) The date on which the transfer of controlled substances will occur. (6) Except for transfer denials by the Secretary, the registrant-transferor may distribute, without being registered to distribute, controlled substances in the registrant-transferor’s possession to the registrant-transferee in accordance with the following procedures, on the date of transfer of the controlled substances: (a) A complete inventory of all controlled substances being transferred shall be taken and serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee; (b) A copy of the inventory shall be included in the records of both the transferor and transferee; (c) A copy of the inventory shall be filed with the Department if requested by the Secretary; (d) Transfers of Schedule I or II controlled substances shall require the use of order forms in accordance with 21 CFR §1305; (e) All transferor-controlled substance records shall be transferred to the transferee; and (f) Pursuant to 21 CFR §1304, transferors are required to make reports, which shall be marked as “Final”. #### Regulation .18 Administrative Inspections and Warrants. *COMAR 10.19.03.18* A. Administrative Inspections. (1) Procedures regarding administrative inspections and warrants pursuant to Criminal Law Article, §§5-305, 5-804, and 5-805, Annotated Code of Maryland, are governed generally by those sections of the Annotated Code and specifically by this regulation. (2) Authority to make inspections is authorized in accordance with Criminal Law Article, §§5-804 and 5-805, Annotated Code of Maryland, to enter controlled premises and conduct administrative inspections for the purpose of the following: (a) Documents required to be kept or made pursuant to 21 CFR §1304, under the Act, or regulations promulgated under the Act may be: (i) Inspected; (ii) Copied; (iii) Verified for correctness; and (iv) Inventoried; (b) Collecting samples of controlled substances or precursors (if samples are collected during an inspection, the inspector shall issue a receipt for these samples to the owner, operator, or agent in charge of the premises); (c) Review of records and information on the distribution of controlled substances by the authorized provider; (d) Reviewing the authorized providers processes; (e) Reviewing the authorized providers controls; and (f) Inspecting the authorized providers facility operations; (3) Entry. (a) An inspection shall be carried out by an inspector. (b) An inspector shall have the right to enter the premises and conduct inspections at reasonable times and in a reasonable manner, upon the following conditions: (i) Stating the inspector’s purpose; and (ii) Presenting to the owner, operator, or agent in charge of the premises to be inspected, appropriate credentials and written notice of the inspector’s inspection authority under Criminal Law Article, §5-305, 5-804, or 5-805, Annotated Code of Maryland. (4) Consent to Inspection of Financial Data, Sales Data Other than Shipment Data, or Pricing Data. (a) If inspection is desired of financing, sales, or pricing data, written consent shall first be obtained from the owner, operator, or agent in charge of the premises to be inspected. (b) This written consent shall contain the following information: (i) That the owner, operator, or agent in charge has the right to refuse to consent to an inspection of these items; (ii) That anything of an incriminating nature which may be found may be seized and used against the owner, operator, or agent in charge in a criminal prosecution; (iii) That the owner, operator, or agent in charge has been presented with a notice of inspection; (iv) That the consent is given by the owner, operator, or agent in charge voluntarily and without threats of any kind; and (v) That the owner, operator, or agent in charge may withdraw the owner’s, operator’s, or agent in charge’s consent at any time during the course of inspection. (c) The written consent shall be produced in duplicate and be distributed as follows: (i) The original will be retained by the inspector; and (ii) The duplicate will be given to the authorized provider inspected. B. Administrative Warrants. (1) Probable Cause. If the Department is satisfied that administrative probable cause exists, the Department shall issue an administrative warrant. (2) Execution of Warrants. An administrative inspection warrant shall be executed as required by Criminal Law Article, §5-804(d), Annotated Code of Maryland. (3) Refusal to Allow Inspection with an Administrative Warrant. If an authorized provider or any person subject to the Act refuses to permit execution of an administrative warrant, or impedes the inspector in the execution of that warrant, the authorized provider or person shall be advised that this refusal or action constitutes a violation of Criminal Law Article, §5-902(a)(3), Annotated Code of Maryland. #### Regulation .19 Hearings, Enforcement, and Disciplinary Sanctions. *COMAR 10.19.03.19* A. Authority for Enforcement Proceeding. (1) A hearing may be ordered or granted by the Secretary, at the Secretary’s discretion, to permit any person against whom criminal or civil action is contemplated under the Controlled Dangerous Substances Act an opportunity to present the individual’s views and the individual’s proposals for bringing the individual’s alleged violations into compliance with the law. The hearing will also permit the individual to show cause why prosecution should not be instituted, or to present the individual’s views on the contemplated proceeding. (2) The rules of procedure for hearings before the Secretary of the Maryland Department of Health shall be governed by COMAR 10.01.03 and State Government Article, §§10-201—10-226, Annotated Code of Maryland. (3) Administrative Hearings. Procedures for administrative hearings shall be governed by the rules set forth in Criminal Law Article, §5-308, if applicable, Health-General Article, §2-207, and State Government Article, §§10-201—10-226, Annotated Code of Maryland, and COMAR 10.01.03. B. After a hearing pursuant to Criminal Law Article, §5-308, if applicable, and State Government Article, §§10-201—10-226, Annotated Code of Maryland, and COMAR 10.01.03, the Secretary may impose a sanction or penalty against any registrant that possesses a Maryland-issued controlled substances registration pursuant to Criminal Law Article, Title V, Annotated Code of Maryland, instead of or in addition to: (1) The denial of an application; (2) The refusal to renew a registration; (3) Suspending a registration; (4) Revoking a registration; (5) Placing restrictions on a registration pursuant to Criminal Law Article, §5-307, Annotated Code of Maryland; or (6) Issuing a nonpublic advisory letter. C. Imposition of Monetary Penalty. (1) After a hearing pursuant to Criminal Law Article, §5-308, Annotated Code of Maryland, the Department may impose a monetary penalty against a controlled substance registration holder pursuant to Criminal Law Article, §5-908, Annotated Code of Maryland. (2) The monetary penalty may be imposed instead of or in addition to the: (a) Suspension of the controlled substances registration; (b) Revocation of the controlled substances registration; or (c) Restrictions placed on the controlled substances registration. (3) The monetary penalty shall be paid within 30 calendar days of the order, unless the order specifies otherwise. (4) Until the imposed fine is paid, the registration may not be: (a) Restored; (b) Reinstated; or (c) Renewed. (5) In its discretion, the Department may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management for collection. D. Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Department and the registrant may agree to a surrender of a registration, or a consent order with terms, sanction, and penalties agreed to by the Department and the registrant. E. Nothing in this chapter prohibits the Department from staying any period of non-active suspension. #### Regulation .20 Additional Controlled Substances in Maryland. *COMAR 10.19.03.20* A. The following substance, also known as a “bath salt”, is added to the Maryland Controlled Dangerous Substances Act, Schedule I of the Criminal Law Article, §5-402, Annotated Code of Maryland: F. 4-Methoxymethcathinone (Methedrone, bk-PMMA, PMMC). B. The following substances are added to the Maryland Controlled Dangerous Substances Act, Schedule III of the Criminal Law Article, §5-404, Annotated Code of Maryland: (1) Butalbital, Acetaminophen, caffeine C-III Fioricet®; and (2) Opium < or = 100mg per 100Gm or 100ml or not more than 5mg per dosage unit C-III. ### Chapter 04 — Prohibition of Smoking or Vaping in Public Indoor Areas **Authority:** Health-General Article, §§24-205 and 24-501 — 24-511, Annotated Code of Maryland **Administrative History:** Effective date: April 21, 1978 (5:8 Md. R. 594) **Administrative History:** Regulation .02W-1 adopted as an emergency provision effective March 26, 1979 (6:7 Md. R. 575); adopted permanently effective June 29, 1979 (6:13 Md. R. 1128) **Administrative History:** Regulation .02PP amended as an emergency provision effective September 11, 1978 (5:9 Md. R. 1442), expired January 20, 1979; adopted permanently effective February 26, 1979 (6:4 Md. R. 277) **Administrative History:** Regulation .02QQQ amended as an emergency provision effective April 27, 1979 (6:10 Md. R. 839) (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Chapter revised effective May 16, 1980 (7:10 Md. R. 952) **Administrative History:** Chapter revised effective November 23, 1981 (8:23 Md. R. 1856) **Administrative History:** Chapter, Drug Formulary of Equivalent Drug Products, repealed effective May 16, 1988 (15:10 Md. R. 1202) **Administrative History:** Chapter, Tobacco Smoking in Retail Stores, adopted effective February 4, 1991 (18:2 Md. R. 149) **Administrative History:** Chapter, Tobacco Smoking in Retail Stores, repealed, and new Chapter, Prohibition of Smoking in Indoor Areas Open to the Public, adopted effective February 1, 2008 (34:26 Md. R. 2262) **Administrative History:** Regulation .01 amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .02B amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .03C, D, F amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .04 amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .05 amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .06 amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .12 repealed effective February 16, 2026 (53:3 Md. R. 122) #### Regulation .01 Scope. *COMAR 10.19.04.01* A. This chapter establishes regulations that preserve and improve the health, comfort, and environment of the people of the State by protecting the public and employees from involuntary exposure to environmental smoke in indoor areas open to the public, except for those covered by Health-General Article, §24-205, Annotated Code of Maryland. B. Nothing in this chapter preempts a county or municipal government from enacting and enforcing more stringent measures to protect the public from involuntary exposure to environmental smoke in indoor areas open to the public. #### Regulation .02 Definitions. *COMAR 10.19.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Act” means the Clean Indoor Air Act of 2007, Health-General Article, Title 24, Subtitle 5, Annotated Code of Maryland. (2) “Cannabis” has the meaning stated in the Alcoholic Beverages and Cannabis Article, §1-101, Annotated Code of Maryland. (3) “Club” means a club as defined in Alcoholic Beverages and Cannabis Article, §1-101, Annotated Code of Maryland. (4) “Day care transportation” means the use of a vehicle owned, operated, or contracted for by a licensed day care facility to transport the facility's clients. (5) “Department” means the Maryland Department of Health. (6) “Electronic smoking device” has the meaning stated in Business Regulation Article, §16.7-101, Annotated Code of Maryland. (7) “Environmental smoke” means the complex mixture formed from the: (a) Smoke of a burning tobacco, cannabis, or hemp product, or exhaled by the smoker; or (b) Aerosol of an electronic smoking device or exhaled as electronic smoking device aerosol. (8) “Establishment” means a single physical location where business is conducted or where services are performed. (9) “Health care transportation” means transportation of patients for medical care in a vehicle owned, operated, or contracted for by a licensed health care facility. (10) “Health officer” means the health officer of each of the 23 counties and the Commissioner of Health in Baltimore City, the duly designated representative of the health officer, or both. (11) “Hemp” has the meaning stated in the Agriculture Article, §14-101, Annotated Code of Maryland. (12) “Indoor area” means all space in a structure or building with a ceiling that is enclosed on all sides by any combination of permanent or temporary walls, windows, or doorways, whether open or closed, or other physical barriers extending from floor to the ceiling. (13) “Indoor area open to the public” means: (a) An indoor area or a portion of an indoor area accessible to the public by either invitation or permission; or (b) An indoor area of an establishment licensed or permitted under the Alcoholic Beverages and Cannabis Article, Annotated Code of Maryland, for the sale or possession of alcoholic beverages. (14) “Owner” means an individual or entity having an ownership interest in an establishment or vehicle. (15) “Person in charge” means an owner, operator, manager, or other person who controls, governs, or directs the activities of an establishment. (16) “Public transportation of children” means the transportation of children in a vehicle owned, operated, or contracted for by a government entity or a private educational institution. (17) “Secretary” means the Secretary of Health or the Secretary's designee. (18) “Smoking” means the burning of a lighted cigarette, cigar, pipe, or another matter or substance containing, wholly or in part, tobacco, cannabis, or hemp. (19) “Tobacco product” has the meaning stated in Health-General Article, §13-1001, Annotated Code of Maryland. (20) “Vaping” means the use of: (a) An electronic smoking device; or (b) Any device through which the user inhales aerosol containing tobacco, cannabis, or hemp. #### Regulation .03 Exclusions. *COMAR 10.19.04.03* This chapter does not apply to: A. Private homes and residences, including a residence used as a business or place of employment, unless being used by a person who is licensed or registered under Family Law Article, Title 5, Subtitle 5, Annotated Code of Maryland, to provide day care or child care; B. Private vehicles, unless being used: (1) For the public transportation of children; or (2) As part of health care or day care transportation; C. A hotel or motel room rented to one or more guests, if the total percent of hotel or motel rooms being rented where smoking or vaping is allowed, does not exceed 25 percent of the guest rooms in the hotel or motel; D. A retail tobacco business that is a sole proprietorship, limited liability company, corporation, partnership, or other enterprise, in which: (1) The primary activity is the retail sale of tobacco products and accessories; and (2) The sale of other products is incidental; E. A facility of a manufacturer, importer, wholesaler, or distributor of tobacco-containing products or a tobacco leaf dealer or processor in which employees of the manufacturer, importer, wholesaler, distributor, or processor work or congregate; and F. A research or educational laboratory for the purpose of conducting scientific research into the health effects of environmental smoke. #### Regulation .04 Prohibition of Smoking or Vaping. *COMAR 10.19.04.04* Except as provided in Regulation .03 of this chapter, an individual may not smoke or vape in: A. An indoor area open to the public; B. An indoor place in which a meeting is open to the public in accordance with State Government Article, Title 10, Subtitle 5, Annotated Code of Maryland; C. An indoor place of employment; D. A government-owned or government-operated means of mass transportation, including: (1) Buses; (2) Vans; (3) Trains; (4) Taxicabs; and (5) Limousines; E. A private home or residence that is being used by a person who is licensed or registered under Family Law Article, Title 5, Subtitle 5, Annotated Code of Maryland, to provide day care or child care; and F. A private vehicle while it is being used: (1) For the public transportation of children; or (2) As part of health care or day care transportation. #### Regulation .05 Owner Requirements. *COMAR 10.19.04.05* A. The owner of a bar, club as defined in Regulation .02B of this chapter, restaurant, pub, tavern, retail establishment, theater, concert hall, athletic facility, financial service institution, government building, educational institution, museum, or library shall: (1) Prohibit smoking or vaping in an indoor area open to the public; and (2) Post a sign indicating where smoking or vaping is prohibited as set forth in Regulation .06A of this chapter. B. An owner of a hotel or motel shall: (1) Prohibit smoking or vaping in an indoor area open to the public except where smoking or vaping is permitted under Regulation .03C of this chapter; and (2) Post a sign indicating where smoking or vaping is permitted or prohibited, as set forth in Regulation .06B and C of this chapter. C. An owner of a vehicle listed in Regulation .04D of this chapter shall: (1) Prohibit smoking or vaping in the vehicle; and (2) Post a sign indicating where smoking or vaping is prohibited as set forth in Regulation .06D of this chapter. D. An owner of an establishment containing an indoor area open to the public not listed in Regulation .05A—C of this chapter shall prohibit smoking or vaping in an indoor area open to the public. #### Regulation .06 Posting of Signs. *COMAR 10.19.04.06* A. An indoor area open to the public and every public entrance to an indoor area open to the public where smoking or vaping is prohibited under Regulation .05A of this chapter shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter. B. A hotel or motel room in which smoking or vaping is permitted shall display a sign containing the words “SMOKING OR VAPING PERMITTED IN THIS ROOM” conforming to the following requirements: (1) The words “SMOKING OR VAPING PERMITTED IN THIS ROOM” are in capital letters; (2) The background and the print are in contrasting colors; and (3) The letters “SMOKING OR VAPING PERMITTED IN THIS ROOM” on the sign are a minimum of 1 inch in height. C. An indoor area open to the public and every public entrance to an indoor area open to the public where smoking is prohibited in a hotel or motel shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter. D. A vehicle where smoking is prohibited under Regulation .04D of this chapter shall display conspicuously a “NO SMOKING OR VAPING” sign that conforms to the requirements of Regulation .06E of this chapter. E. Sign Requirements. A “NO SMOKING OR VAPING” sign: (1) Shall contain the words “NO SMOKING OR VAPING” composed of letters at least one inch in height; (2) May contain the following symbols: (a) The international symbol for “no smoking”, consisting of a pictorial representation of a burning cigarette enclosed in a circle with a bar across the circle; (b) The international symbol for “no smoking” and pictorial representation of an electronic smoking device enclosed in a circle with a bar across the circle or pictorial representations of an electronic smoking device and a cannabis leaf, enclosed in separate circles, with a bar across each circle; (c) A modified international symbol for “No Smoking”, consisting of a circle with a bar across the circle, with the circle containing pictorial representations of a burning cigarette and an electronic smoking device or electronic smoking device and a cannabis leaf; or (d) Any combination of §E(2)(a)—(c) of this regulation; and (3) May contain additional information, such as: (a) The words, “For information on quitting smoking, call 1-800-QUIT NOW (1-800-784-8669)”; (b) The words “WARNING: TOBACCO SMOKE CAUSES CANCER AND HEART DISEASE AND CAN HARM YOUR CHILD.”; or (c) The words “WARNING: CANNABIS SMOKE CAN HARM LUNG TISSUE AND HAS MANY OF THE SAME CARCINOGENS AS TOBACCO SMOKE.” F. The owner or person in charge shall ensure that a sign required under this regulation is conspicuously posted and in good condition. #### Regulation .07 Complaints and Investigations. *COMAR 10.19.04.07* A. A person may register a complaint of a violation of a requirement of this chapter by means of: (1) A written complaint to the health officer in the jurisdiction where the alleged violation took place; or (2) A telephone complaint to the health officer in the jurisdiction where the alleged violation took place. B. The Department shall make available a complaint form at the Department's website and at a local health department. C. Upon receipt of a complaint, the health officer or the health officer's designee shall: (1) Record the complaint on the complaint form; and (2) Investigate the complaint. #### Regulation .08 Enforcement. *COMAR 10.19.04.08* A. A health officer or the health officer's designee may investigate conditions relative to the enforcement of this chapter. B. The person in charge of an establishment shall permit a health officer or health officer's designee to enter an establishment during its business hours for the purpose of determining compliance with this chapter. C. When an investigation is made, the health officer or the health officer's designee shall: (1) Document: (a) The result of the investigation on a report form provided by the Department; and (b) A condition found that is in violation of the provisions of this chapter; (2) Furnish one copy of the report form to the person in charge of the establishment; and (3) Make the completed report form available for public disclosure in accordance with State Government Article, §10-611— 10-628, Annotated Code of Maryland. #### Regulation .09 Violations and Certification of Correction. *COMAR 10.19.04.09* A. The health officer or the health officer's designee shall notify the owner of an establishment found in violation of a provision of this chapter or the Act: (1) By certified mail, return receipt requested, bearing a postmark from the United States Postal Service; (2) Of the specific finding and the penalty for the violation as set forth in Regulation .10 of this chapter; (3) Of a specific date by which the owner shall correct the violation; (4) That if the owner fails to correct the violation by the date specified, or is in violation of another provision of this chapter or the Act at another time, the Secretary may impose a subsequent penalty as set forth in Regulation .10 of this chapter; and (5) That the owner is entitled to request a hearing under Regulation .11 of this chapter on a violation and penalty, as set forth in Regulation .10 of this chapter. B. The owner of an establishment shall submit to the health officer a certification of correction within a time frame provided by the local health department that: (1) Lists a violation; and (2) Includes a description of how the correction was accomplished. #### Regulation .10 Penalties. *COMAR 10.19.04.10* A. A person who violates a provision of this chapter is subject to the following penalties: (1) A written reprimand by the Secretary for the first violation; (2) A civil penalty of $100 for a second violation; (3) A civil penalty of $500 for the third violation; and (4) A civil penalty of $1,000 per violation for each subsequent finding of violation. B. The Department shall pay a penalty collected under this regulation to the Cigarette Restitution Fund established under State Finance and Procurement Article, §7-317, Annotated Code of Maryland. #### Regulation .11 Request for Hearing. *COMAR 10.19.04.11* A. In order to preserve a right to a hearing on a violation and penalty of this chapter, a person shall submit a written request to the Department for a hearing, if a hearing is desired, within 10 days of receipt of the notice of violation and penalty. B. In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation by referring the matter to the Office of Administrative Hearings. C. The Office of Administrative Hearings shall: (1) Schedule and conduct the hearing on the violation; and (2) Render a decision and notify the parties of the decision within 30 days after the hearing. ### Chapter 05 — Flammable Articles **Authority:** Health-General Article, Title 22, Subtitle 4, Annotated Code of Maryland **Administrative History:** Effective date: June 30, 1978 (5:13 Md. R. 1063) **Administrative History:** Regulation .01 amended and recodified to Regulations .01 and .02 effective October 23, 1995 (22:21 Md. R. 1616) #### Regulation .01 Incorporation by Reference. *COMAR 10.19.05.01* Except for the changes shown in Regulation .02 of this chapter, all provisions of 16 CFR 1602, 1605, 1608, 1609, 1610, 1611, 1615, 1616, and 1632, are incorporated by reference. #### Regulation .02 Definitions. *COMAR 10.19.05.02* A. In the incorporation by reference cited in Regulation .01 of this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Act” means the Maryland Flammable Products Act, Health-General Article, Title 22, Subtitle 4, Annotated Code of Maryland. (2) “Commission” means the Maryland Department of Health. ### Chapter 06 — Poison Prevention Packaging **Authority:** Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland **Administrative History:** Effective date: November 3, 1978 (5:22 Md. R. 1673) **Administrative History:** Regulation .01 amended effective January 7, 1991 (17:26 Md. R. 2975) #### Regulation .01 Incorporation by Reference of Poison Prevention Packaging Regulations. *COMAR 10.19.06.01* A. All provisions of 16 Code of Federal Regulations, Part 1700, are incorporated by reference, except for the changes shown in §B of this regulation. B. Definitions (see 16 CFR 1700, §1700.1). (1) “Act” means Child Resistant Packaging of Dangerous Household Substances, Health-General Article, §§22-301 — 22-312, Annotated Code of Maryland. (2) “Commission” means the Maryland Department of Health. (3) “Dietary supplement” means a vitamin or mineral preparation, or both, offered in tablet, capsule, wafer, or other similar uniform unit form; in powder, granule, flake, or liquid form; or in the physical form of a conventional food but which is not a conventional food; and which purports or is represented to be for special dietary use by humans to supplement their diets by increasing the total dietary intake of one or more of the essential vitamins or minerals, or both. ### Chapter 07 — Prohibition of Child Care Products Containing TCEP or TDCPP **Authority:** Health-General Article, §§24-306 and 24-306.1, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.04 adopted as an emergency provision effective October 1, 2013 (40:22 Md. R. 1871); adopted permanently effective January 6, 2014 (40:26 Md. R. 2164) **Administrative History:** Regulation .01A amended effective January 19, 2015 (42:1 Md. R. 18) **Administrative History:** Regulation .02B amended effective January 19, 2015 (42:1 Md. R. 18); December 25, 2023 (50:25 Md. R. 1088) **Administrative History:** Regulation .03 amended effective January 19, 2015 (42:1 Md. R. 18) #### Regulation .01 Scope. *COMAR 10.19.07.01* A. This chapter establishes regulations that prohibit the import, sale, or offering for sale of child care products containing: (1) TCEP, also known as (tris (2-chloroethyl) phosphate); or (2) TDCPP, also known as (tris (1, 3-dichloro-2-propyl) phosphate). B. This chapter does not apply to the sale or distribution of a child care product that is resold, offered for resale, or distributed by a consumer for consumer use. #### Regulation .02 Definitions. *COMAR 10.19.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Child care product” means a consumer product intended for use by a child under the age of 3 years, including a: (a) Baby product; (b) Toy; (c) Car seat; (d) Nursing pillow; (e) Crib mattress; and (f) Stroller. (2) “Secretary” means the Secretary of Health. (3) “TCEP” means an industrial chemical also known as (tris (2-chloroethyl) phosphate). (4) “TDCPP” means an industrial chemical also known as (tris (1, 3-dichloro-2-propyl) phosphate). #### Regulation .03 Prohibition of TCEP or TDCPP in Child Care Products. *COMAR 10.19.07.03* A. A person may not import, sell, or offer for sale any child care product containing more than 1/10 of 1 percent of TCEP by mass. B. On or after October 1, 2014, a person may not import, sell, or offer for sale any child care product containing more than 1/10 of 1 percent of TDCPP by mass. C. The Secretary may suspend implementation of this chapter if the Secretary determines that the fire safety benefits of TCEP or TDCPP are greater than the known health risks associated with TCEP or TDCPP. #### Regulation .04 Violations. *COMAR 10.19.07.04* A. A person that violates this chapter is subject to: (1) For a first violation, a civil penalty not exceeding $1,000; and (2) For any subsequent violation, a civil penalty not exceeding $2,500 for each violation. B. In addition to the civil penalties described in §A of this regulation, a court may also enjoin an action prohibited in Regulation .04 of this chapter. ### Chapter 08 — Prohibition of Consumer Products Containing Flame-Retardant Chemicals **Authority:** Health-General Article, §24-306.1, Annotated Code of Maryland **Administrative History:** Effective date: December 25, 2023 (50:25 Md. R. 1088) #### Regulation .01 Scope. *COMAR 10.19.08.01* A. This chapter establishes regulations that prohibit the import, sale, or offering for sale of juvenile products, mattresses, upholstered furniture, or reupholstered furniture containing more than 0.1 percent of flame-retardant chemical by mass. B. This chapter does not apply to the sale or distribution of a juvenile product, a mattress, upholstered furniture, or reupholstered furniture that is resold, offered for resale, or distributed by a consumer for consumer use. #### Regulation .02 Definitions. *COMAR 10.19.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adult mattress” means any mattress other than a toddler mattress, a crib mattress, or any other infant sleep product. (2) “Flame-retardant chemical” means a chemical that: (a) Is used to resist or inhibit the spread of fire or act as a synergist to chemicals that resist or inhibit the spread of fire, including any chemical for which the term “flame retardant” appears on a safety data sheet developed in accordance with 29 CFR §1910.1200(g); and (b) Is a nanoscale chemical or has one or more of the following properties: (i) Contains one or more halogen elements, including fluorine, chlorine, bromine, or iodine; (ii) Contains one or more carbon elements and one or more phosphorus elements; and (iii) Contains one or more carbon elements and one or more nitrogen elements. (3) Juvenile Product. (a) “Juvenile product” means a consumer product intended for use by a child younger than 12 years old. (b) “Juvenile product” includes: (i) A bassinet; (ii) A booster seat; (iii) A changing pad; (iv) A children’s nap mat; (v) A floor playmat; (vi) A high chair; (vii) A high chair pad; (viii) An infant bouncer; (ix) An infant carrier; (x) An infant seat; (xi) An infant swing; (xii) An infant walker; (xiii) A nursing pad; (xiv) A nursing pillow; (xv) A playpen side pad; (xvi) A play yard; (xvii) A portable hook-on chair; and (xviii) A stroller. (c) “Juvenile product” does not include a: (i) Product that is not primarily intended for use in the home, including a product that is, or is a component part of, a motor vehicle, a watercraft, an aircraft, or any other vehicle; (ii) Product regulated under 49 CFR Part 571; (iii) Consumer electronic product; or (iv) Child care product regulated under Health-General Article, §24-306, Annotated Code of Maryland, or COMAR 10.19.07. (4) “Mattress” has the meaning stated in 16 CFR § 1632.1. (5) “Reupholstered furniture” means furniture for which the original fabric, padding, decking, barrier material, foam, or other resilient filling has been replaced and that has not been sold since the time of replacement. (6) “Upholstered furniture” means furniture that includes filling materials, barrier materials, decking materials, or cover fabrics. #### Regulation .03 Prohibition of Flame-Retardant Chemicals in Consumer Products. *COMAR 10.19.08.03* A. This regulation does not apply to: (1) An electronic component, or the casing for an electronic component, of a juvenile product, a mattress, upholstered furniture, or reupholstered furniture; (2) A component of upholstered or reupholstered furniture other than cover fabric, barrier material, resilient filling material, and decking material; (3) Thread or fiber when used for stitching mattress components together; or (4) Except for foam, a component of an adult mattress. B. A person may not import, sell, or offer for sale any juvenile product, mattress, upholstered furniture, or reupholstered furniture that contains more than 0.1 percent of flame-retardant chemicals by mass. #### Regulation .04 Complaints and Investigations. *COMAR 10.19.08.04* A. The Secretary or the Secretary’s designee may investigate conditions relative to the enforcement of this chapter. B. The person in charge of an establishment shall permit the Secretary or the Secretary’s designee to enter an establishment during its business hours for the purpose of determining compliance with this chapter. C. The person in charge of an establishment shall provide to the Secretary or the Secretary’s designee product safety data sheets, technical specifications, and any information available related to the composition of the juvenile product. #### Regulation .05 Violations. *COMAR 10.19.08.05* A. If a person willfully violates this chapter, the Secretary may assess a civil penalty: (1) For a first violation after receiving a letter of reprimand, not exceeding $2,500; (2) For a second violation, not exceeding $5,000; (3) For a third violation, not exceeding $7,500; and (4) For any subsequent violation, not exceeding $10,000 for each violation. B. In determining the amount of a penalty under §A of this regulation, the Secretary shall consider: (1) The nature and severity of the violation; (2) The good faith of the person; (3) The history of violations by the person; (4) The extent to which the person cooperated with any investigation by the Department; and (5) Whether the person has previously been issued a letter of reprimand. C. For a violation of this chapter, the Secretary shall issue a letter of reprimand. #### Regulation .06 Request for Hearing. *COMAR 10.19.08.06* A. In order to preserve a right to a hearing on a violation and penalty of this chapter, a person shall submit a written request to the Department for a hearing, if a hearing is desired, within 10 days of receipt of the notice of violation and penalty. B. In accordance with the Administrative Procedure Act, State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, the Secretary shall provide for a hearing on the violation by referring the matter to the Office of Administrative Hearings. C. The Office of Administrative Hearings shall: (1) Schedule and conduct the hearing on the violation; and (2) Render a decision and notify the parties of the decision within 30 days after the hearing. ## Subtitle 20 — Kidney Disease Program ### Chapter 01 — General Regulations **Authority:** Health-General Article, §§13-301 — 13-315 and 16-204, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Chapter, Control of Noise Pollution, transferred to Title 26 Department of the Environment, June, 1988 **Administrative History:** Regulations .01 — .10, General Regulations (Kidney Disease Program), adopted as an emergency provision effective November 1, 1991 (18:23 Md. R. 2481); emergency status expired March 30, 1992 **Administrative History:** Regulations .01 — .10 adopted effective March 31, 1992 (19:3 Md. R. 304) **Administrative History:** Chapter revised as an emergency provision effective November 29, 1999 (26:26 Md. R. 1958); revised permanently effective March 8, 2000 (27:4 Md. R. 454) **Administrative History:** Regulation .01B amended effective June 21, 2004 (31:12 Md. R. 912); April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .02C amended effective April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .03 amended effective April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .03D amended effective February 12, 2007 (34:3 Md. R. 299) **Administrative History:** Regulation .05D amended effective April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .07 amended effective April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .07G, H amended effective June 21, 2004 (31:12 Md. R. 912) **Administrative History:** Regulation .08 amended effective April 4, 2011 (38:7 Md. R. 431) **Administrative History:** Regulation .08A amended effective February 12, 2007 (34:3 Md. R. 299) **Administrative History:** Regulation .09C amended effective April 4, 2011 (38:7 Md. R. 431) #### Regulation .01 Definitions. *COMAR 10.20.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual who has applied for, or is in the process of applying for, Kidney Disease Program enrollment and has not yet been certified as an eligible recipient. (2) “Certification period” means the 12-month period during which an individual is certified as eligible to receive Kidney Disease Program benefits. (3) “Certified facility” means a hospital, dialysis facility, or transplantation center which the Department certifies meets the standards that the Commission adopts for providing services to recipients and which is certified by Medicare. (4) “Commission” means the State Commission on Kidney Disease. (5) “Department” means the Maryland Department of Health. (6) “Dialysis” means chronic hemodialysis or chronic peritoneal dialysis provided in a certified facility or a facility approved by the Commission or in the patient's home under the auspices of a certified facility or home dialysis program approved by the Commission. (7) “End stage renal disease (ESRD)” means that stage of renal impairment that appears irreversible and permanent, and requires a regular course of maintenance dialysis or kidney transplantation to maintain life. (8) “Family” means the recipient and all of the following individuals sharing the same household with the recipient: (a) The recipient's spouse; (b) The recipient's natural or adopted children who are younger than 21 years old; (c) The recipient's natural or adoptive parent, if the recipient is a child younger than 21 years old; and (d) The recipient's stepchildren or grandchildren for which the recipient has legal or presumed guardianship. (9) “Liquid assets” means cash or an asset that can readily be converted to cash. (10) “Medical Assistance” means the State program of comprehensive medical and other health-related care for indigent and medically indigent persons. (11) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq. (12) “Poverty income guidelines” means the federal poverty income guidelines contained in the most recent annual update of the Department of Health and Human Services poverty income guidelines as published in the Federal Register. (13) “Preauthorization” means an approval required from the Program before services are rendered to a recipient. (14) “Primary Adult Care Program (PAC)” has the meaning stated in COMAR 10.09.60.02. (15) “Program” means the Kidney Disease Program of Maryland. (16) “Program participation fee” means an annual premium which may be assessed by the Program and is based on family income or liquid assets, or both. (17) “Provider” means an individual, association, partnership, corporation, or unincorporated group licensed or certified to provide health care services for Program recipients. (18) “Qualified alien” means an alien who: (a) Has been fully admitted for permanent residence in the United States under the Immigration and Nationality Act (INA); (b) Has been granted asylum in the United States under §208 of the INA; (c) Has been admitted into the United States as a refugee under §207 of the INA; (d) Has been paroled into the United States under §212(d)(5) of the INA for a period of at least 1 year; (e) Has had deportation withheld under §243(h) of the INA; or (f) Has been granted conditional entry into the United States under §203(a)(7) of the INA in effect before April 1, 1980. (19) “Quarterly amount” means the quarterly installment payment which is equal to 25 percent of a recipient's annual Program participation fee. (20) “Recipient” means an individual who is certified for enrollment in the Kidney Disease Program of Maryland. (21) “Reimbursable drug list” means the Kidney Disease Program formulary of medications approved for payment. (22) “Representative” means an individual who, because of an applicant's or a recipient's mental or physical incapacity or youth, or specified dialysis or transplant facility personnel who have been so designated by virtue of the applicant's or recipient's voluntarily signed authorization form, is authorized, in accordance with State law, to complete, sign, or withdraw an application for enrollment in the Program or to activate a hearing process. (23) Resident. (a) “Resident” means an individual permanently living in Maryland whose temporary absence from the State does not interrupt continuity of residence. (b) “Resident” does not mean: (i) Members or their families, or both, of the United States armed services temporarily stationed in Maryland; or (ii) Foreign nationals employed in embassies of their native country. #### Regulation .02 Program Application Process. *COMAR 10.20.01.02* A. A Maryland resident diagnosed with end-stage renal disease may apply for certification with the Program. B. An applicant, or the applicant's representative, shall complete a written application on the form designated by the Program. C. Application Supporting Documents. (1) The Program may require the following as part of the application form or in addition to the application form: (a) Copies of the previous year's federal income tax return of the applicant and each individual in the applicant's family; (b) Current statements of liquid assets owned by the applicant and each individual in the applicant's family; (c) The amount of the current Social Security benefits and all retirement or pension benefits, or both, of the applicant and each individual in the applicant's family; (d) Documentation of the applicant’s identity as well as citizenship or nationality, to the Department’s satisfaction, based on federal requirements; (e) Verification of the applicant's status as a resident of Maryland; (f) Verification of the applicant’s Medicare status; (g) Verification concerning the applicant's enrollment in any health insurance benefit plan; (h) Physician's certification that the applicant has ESRD; (i) Physician's certification that the applicant has begun a regular course of maintenance renal dialysis in a certified facility or received a renal transplant, or both; (j) A signed statement authorizing the Program to verify, from any source including banks, insurance companies, and public or private agencies providing monetary benefits, information submitted to the Program by the applicant; and (k) Other information the Program determines is needed to establish whether the applicant is eligible to be a recipient. (2) Refusal to sign an authorization that may be required under §C(1)(j) of this regulation is considered failure to provide sufficient information, and the applicant will be determined ineligible without prejudice in accordance with §F of this regulation. (3) In reference to §C(1)(a) of this regulation, the Program may accept the previous year's tax return through April 15 of the year in which an application for certification is filed. After April 15, the Program requires the new tax return or proof of extension granted for filing a return. D. Signature Requirements. (1) For the purpose of establishing eligibility, the applicant or the applicant's representative, as appropriate, shall complete and sign the application form. (2) A physician shall sign the certification that the applicant has ESRD and has begun a regular course of maintenance renal dialysis, or has received a renal transplant, or both. E. The applicant or the applicant's representative shall forward the completed application form and supporting documents to the address designated on the form. F. An applicant shall provide all required information within 90 days from the date the information is originally requested by the Program or the applicant shall be determined ineligible without prejudice and may reapply. G. The applicant, or the applicant's representative, may voluntarily withdraw an application at any time without prejudice. H. If the Program determines that an applicant is not eligible for Program enrollment, the Program shall notify the applicant or the applicant's representative, as appropriate, in writing within 45 days of receipt of a completed application and include the following in the notice: (1) The basis for the determination of ineligibility; (2) An explanation of the right to request a hearing; and (3) A statement that the applicant is permitted to submit a new application for Program enrollment at any time. I. If the Program determines that an applicant is eligible for Program enrollment, the Program shall: (1) Establish a certification period in accordance with Regulation .03C of this chapter; (2) Notify the applicant or the applicant's representative, as appropriate, in writing within 45 days of receipt of a completed application; (3) Issue a Kidney Disease Program recipient identification card and instructions for using the card; and (4) Notify the applicant or the applicant's representative, as appropriate, about any Program participation fee due in accordance with Regulation .04 of this chapter. #### Regulation .03 Recipient Eligibility and Certification for Program Participation. *COMAR 10.20.01.03* A. To be eligible for enrollment in the Program an applicant shall: (1) Be a resident of Maryland and one of the following: (a) A citizen of the United States, (b) A qualified alien, as specified in §C of this regulation, who is eligible in accordance with the requirements related to the 5-year bar specified at §D of this regulation; or (c) An alien who is: (i) Eligible for and receiving Supplemental Security Income (SSI); (ii) A member of a federally recognized Indian tribe, as defined in 25 U.S.C. §450b(e); or (iii) An American Indian born in Canada to whom §289 of the Immigration and Nationality Act (INA) applies. (2) Be certified by a physician as having end stage renal disease; (3) Meet one of the following requirements: (a) Have begun a regular course of maintenance renal dialysis in a certified facility or have received a renal transplant, or both; or (b) Have begun a course of maintenance renal dialysis in an out-of-State facility when the Program has preauthorized the treatment based on the facility's proximity to the applicant's residence or to assure continuity of care, or both; and (4) Submit an application in accordance with Regulation .02 of this chapter. B. An individual detained by a federal, state, or local penal or correctional system as a result of a charge, indictment, or conviction of a criminal offense is not eligible for Program enrollment. C. Qualified Aliens. According to §431 of the Personal Responsibility and Work Opportunity and Reconciliation Act of 1996 (PRWORA), qualified aliens admitted to the United States shall include: (1) The following types of aliens, who may be subject to the 5-year bar specified at §D of this regulation, depending on their most recent date of entry and their date of qualified alien status: (a) Aliens who were lawfully admitted to the United States for permanent residence or who since admission were granted lawful permanent resident status in accordance with the INA; (b) Aliens granted parole for at least 1 year under §212(d)(5) of the INA; and (c) A documented or undocumented immigrant who was battered or subjected to extreme cruelty by the individual’s United States citizen or lawful permanent resident spouse or parent, or by a member of the spouse’s or parent’s family residing in the same household as the immigrant, if: (i) The spouse or parent consented to, or acquiesced in, the battery or cruelty; (ii) The abusive act or acts occurred in the United States; (iii) The individual responsible for the battery or cruelty no longer lives in the same household as the victim; (iv) A Violence Against Women Act immigration case or a family-based visa petition has been filed; and (v) There is a substantial connection between the battery or cruelty and the need for Medical Assistance benefits; and (2) The following types of aliens, who are not subject to the 5-year bar specified in §D of this regulation: (a) Alien children and pregnant women who are lawfully residing in the United States, including legal permanent residents who have resided in the United States for less than 5 years as described under §214 of the Children’s Health Insurance Program Authorization Act of 2009 (CHIPRA); (b) Aliens who were lawfully admitted to the United States for permanent residence as Amerasian immigrants under §584 of the Foreign Operations, Export Financing and Related Programs Appropriations Act of 1988; (c) Refugees admitted under §207 of the INA; (d) Aliens granted asylum under §208 of the INA; (e) Aliens whose deportation is being withheld under: (i) §243(h) of the INA as in effect prior to April 1, 1997; or (ii) §241(b)(3) of the INA, as amended; (f) Cuban or Haitian entrants, as defined at §501(e) of the Refugee Education Assistance Act of 1980; (g) Aliens granted conditional entry under §203(a)(7) of the INA in effect before April 1, 1980; (h) Children receiving federal payments for foster care or adoption assistance under Part B or E of Title IV of the Social Security Act, if the child’s foster or adoptive parent is considered a citizen or qualified alien; and (i) Victims of a severe form of trafficking, in accordance with §107(b)(1) of the Trafficking Victims Protection Act of 2000, who have been subjected to: (i) Sex trafficking if the act is induced by force, fraud, or coercion, or the individual who was induced to perform the act was younger than 18 years old on the date that the visa application was filed; or (ii) Involuntary servitude. D. Five-Year Bar to Program Benefits for Qualified Aliens. (1) Qualified aliens in the categories specified in §C(1) of this regulation who entered the United States on or after August 22, 1996, were not eligible for Program benefits for 5 years from the date that the qualified alien: (a) Entered the United States with the status of a qualified alien; or (b) Obtained the status of a qualified alien, if the individual did not enter the United States as a qualified alien. (2) The 5-year bar specified in §D(1) of this regulation shall also be applied to qualified aliens who entered the United States before August 22, 1996, but did not remain continuously present in the United States from the last date of entry before August 22, 1996 until the date of qualified alien status. (3) An alien is not considered to be continuously present in the United States as specified in §D(2) of this regulation if, before the date of qualified alien status, the alien had: (a) A single absence from the United States of more than 30 days; or (b) Absences from the United States totaling more than 90 days. (4) The 5-year bar to eligibility for Program benefits, specified in §D(1) of this regulation, does not apply to: (a) Qualified aliens in the categories specified at: (i) §C(1) of this regulation, who are not subject to the 5-year bar in accordance with §D(1) or (2) of this regulation; or (ii) §C(2) of this regulation; (b) A qualified alien who is: (i) An honorably discharged veteran of the armed forces of the United States; (ii) On active duty in the armed forces of the United States; or (iii) The lawfully admitted spouse, including a surviving spouse who has not remarried, or lawfully admitted unmarried dependent child of an honorably discharged veteran or individual on active duty in the armed forces of the United States; and (c) Lawful permanent residents who: (i) Entered the United States under another exempt category specified at §D(4)(a) — (b) of this regulation; and (ii) Converted to lawful permanent resident status. E. Certification Period. (1) The Program shall establish the certification period during which an individual is eligible to receive Program benefits. (2) The certification period shall be retroactive to the first day of maintenance renal dialysis or renal transplantation if a completed application is received by the Program within 30 days after the first day of maintenance renal dialysis, or within 30 days after renal transplantation, whichever treatment occurs first. (3) If a completed application is received by the Program more than 30 days after the first day of maintenance renal dialysis, or more than 30 days after the date of renal transplantation, whichever treatment occurs first, the certification period shall begin on the first day of the month in which the completed application is received by the Program. (4) The Program shall certify a recipient for a 12-month period. (5) The Program shall promptly redetermine eligibility when it receives information concerning a recipient's circumstances that may affect continuing eligibility. F. A recipient shall comply with the following requirements to continue Program enrollment throughout a certification period: (1) Unless a recipient can document continuing insurance coverage that is equal to or greater than Medicare benefits, apply for enrollment in Part A, Part B, and Part D of Medicare within 60 days of notification to do so by the Program, if not already a Medicare beneficiary; (2) Apply for enrollment in Part A, Part B, and Part D of Medicare within 60 days following termination of insurance coverage that is equal to or greater than Medicare benefits; (3) Maintain enrollment in Part A, Part B, and Part D of Medicare if eligible; (4) Apply for enrollment in Medical Assistance within 60 days of notification to do so by the Program; (5) Maintain enrollment in Medical Assistance if eligible; (6) Continue to meet the requirements of §§A and I of this regulation; (7) Reimburse the Department any monies received from any insurance company or other third party for payment of ESRD treatment costs previously reimbursed by the Program; and (8) Pay the Program participation fee, if applicable, in accordance with Regulation .04 of this chapter. G. A recipient is considered to have failed to meet the requirement of §F(4) of this regulation if: (1) The recipient fails to provide information required for certification or recertification of Medical Assistance eligibility; or (2) Medical Assistance disenrolls the recipient because of recipient fraud, recipient abuse, or recipient failure to comply with reporting requirements. H. Reapplication for Continuation of Certification. (1) The Program shall notify the recipient in writing 60 days before an annual certification period expires. (2) A recipient shall complete a written application for continuation of certification for Program benefits. (3) A recipient shall be disenrolled from the Program upon expiration of a certification period unless the Program receives a completed application for continuation of certification 30 days before expiration of a certification period. I. The recipient shall notify the Program within 30 working days of: (1) A payment received from any source that is related to treatment of the recipient's ESRD; (2) The recipient's regaining renal function; (3) A change in address; or (4) A change in State residence, citizenship, or alien status. J. Termination Before Expiration of Certification Period. (1) The Program shall terminate a recipient’s enrollment in the Program before expiration of the current certification period if the recipient: (a) Fails to provide the notice required by §I of this regulation; (b) Voluntarily disenrolls; (c) No longer meets the medical requirements for participation; (d) No longer meets the residence, citizenship, or alien status requirements of §A(1) of this regulation; (e) Fails to pay the Program participation fee described in Regulation .04 of this chapter; (f) Fails to apply for and maintain enrollment in Medicare, if eligible; (g) Fails to apply for and maintain enrollment in the Medical Assistance Program if required by the Program; (h) Fails to pay the Department any monies received from any source for payment of ESRD treatment costs previously reimbursed by the Program; (i) Has not received a kidney transplant but no longer requires a regular course of maintenance dialysis, 12 months after the date on which the course of dialysis is terminated; (j) Is incarcerated by a federal, state, or local penal or correctional system; (k) Has used the Program identification number to fraudulently obtain goods or services, or permits another individual to use the Program identification number to fraudulently obtain goods or services; (l) Fails to pay the quarterly amount within the required time frame and the Program has not paid for any services provided for the recipient within the quarter; or (m) Has died. (2) Pursuant to §J(1)(l) of this regulation, termination is considered voluntary withdrawal and becomes effective retroactive to the first day of the quarter billed. K. Continuing Certification and Termination Notices. (1) The Program shall inform a recipient, or the recipient's representative, of the recipient's rights and obligations regarding continuing certification and termination of Program enrollment. (2) The Program shall give the recipient or the recipient’s representative written notification of the following: (a) That a certification period is due to expire and reapplication is required as set forth in §H of this regulation; (b) The effective date of termination of Program enrollment when: (i) The recipient no longer meets the residence, citizenship, or alien status requirements; (ii) The recipient is incarcerated; or (iii) The recipient has died; and (c) The Program’s intent to terminate the recipient’s enrollment for reasons other than those set forth in §K(2)(a) and (b) of this regulation. (3) A notice that the certification period is about to expire or of the Program's intent to terminate the recipient's enrollment due to the recipient's failure to apply for recertification or to pay the assessed quarterly premium shall: (a) Be mailed at least 30 calendar days before the date on which the action is to be effective; (b) Include a statement of the proposed actions, the reasons for the action, and the regulatory citation supporting the action; and (c) Include an explanation of the right to request a hearing. L. If the Program determines that the recipient has used the Program identification number to fraudulently obtain goods or services, or has permitted another individual to use the Program identification number to fraudulently obtain goods or services, and certification is terminated pursuant to §J(1)(k) of this regulation, the recipient is not eligible to reapply for Program certification. #### Regulation .04 Program Participation Fee. *COMAR 10.20.01.04* A. A recipient whose family income exceeds 175 percent of the poverty income guidelines or whose family liquid assets exceed 200 percent of the poverty income guidelines, or both, at the time of initial application or reapplication is required to pay an annual Program participation fee. B. Family income for purposes of this regulation includes the adjusted gross income, as defined in the Internal Revenue Code for federal income tax purposes, plus Social Security benefits, all pension or retirement benefits, or both, and all interest income not otherwise included in the adjusted gross income for federal income tax purposes, of the recipient and each person in the recipient's family. C. The Program shall establish a recipient's annual Program payment fee equal to the sum of: (1) 5 percent of the amount by which the family income exceeds 175 percent of the poverty income guidelines adjusted for family size; plus (2) 5 percent of the family's liquid assets above 200 percent of the poverty income guidelines adjusted for family size. D. For purposes of §C(2) of this regulation, the Program shall: (1) Include assets which are available as of the date of application for initial enrollment or certification of continuing enrollment, as applicable, in the family's liquid assets; (2) Include the following in the family's liquid assets: (a) Cash; (b) Savings and checking accounts; (c) Certificates of deposit; (d) Stocks; (e) Bonds; (f) Life insurance cash value exceeding $1,500; (g) Mutual funds; (h) Money market certificates; and (i) Other financial instruments or investments that can readily be converted to cash; and (3) Exclude the following from the family's liquid assets: (a) Items of real property; and (b) Items of personal property. E. Collection of Fees. (1) The Department shall collect the annual Program participation fee in quarterly installments. (2) The Program shall notify the recipient of the amount of the annual Program participation fee, the quarterly amount to be paid, the payment due date, and payment procedures. (3) The Program may revise the amount of the Program participation fee during a certification period if the Program determines that a revision should be made because of a change in: (a) Family income; (b) Family liquid assets; or (c) Composition of the family unit. (4) The recipient shall have a grace period lasting from the first day of the quarter until 30 days before the end of the quarter in which to pay the quarterly amount. (5) The recipient's enrollment in the Program shall be terminated on the last day of the quarter if a fee amount is not paid by the end of the grace period. (6) The recipient is responsible for the assessed quarterly amount if the Program receives claims and makes payment for services provided for the recipient within the quarterly billing period. (7) The Program shall extend the grace period for up to 6 months when the Program determines that, due to extraordinary medical expenses paid by the recipient, a change in family income, or frequent or extended hospitalizations, payment within the grace period will cause substantial hardship to the recipient. (8) The Department may not refund the Program participation fee paid when the recipient’s Program enrollment is terminated unless termination occurs before the start of the quarter for which the Program participation fee was paid. (9) Before the Program will recertify an applicant whose prior Program enrollment was terminated for failure to pay the Program participation fee in accordance with this regulation, the applicant shall: (a) Pay any unpaid fees owing for all prior enrollment periods during which the applicant was enrolled in the Program; and (b) Make advance payment of the first quarterly installment of the Program participation fee established for the subsequent enrollment period. #### Regulation .05 Preauthorization. *COMAR 10.20.01.05* A. The following procedures or services require preauthorization: (1) Treatment that is provided outside of Maryland; (2) Pre-renal transplant dental services; (3) Ancillary supplies for home intravenous antibiotic therapy; (4) Durable medical equipment and disposable medical supplies used in the home; and (5) One pair of eyeglasses, one time only. B. The Program may preauthorize services when the provider submits to the Program adequate documentation demonstrating that the service to be preauthorized is directly related to treatment of the recipient's ESRD. C. Renal transplantation services provided to a recipient outside of Maryland are not eligible for reimbursement unless the Commission gives prior written approval for the transplant. D. The Program does not cover: (1) Any service denied by Medicare as not medically justified or any services covered by Medical Assistance; or (2) Services which are investigational or experimental. E. In cases of multiple organ transplants, Program coverage shall be limited to only those services related to transplantation of the kidney. The provider shall break out and satisfactorily document the charges related to the kidney transplant before submitting a reimbursement request to the Program. #### Regulation .06 License Requirements. *COMAR 10.20.01.06* A. A pharmacy may not qualify as a provider without first having obtained a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located. B. A pharmacy that provides compounded prescriptions for home intravenous therapy shall be licensed under the provisions of COMAR 10.34.19. C. A doctor of medicine or osteopathy shall be licensed and legally authorized to practice medicine and surgery, and to dispense drugs in the state in which the service is provided. #### Regulation .07 Provider Reimbursement. *COMAR 10.20.01.07* A. To qualify as a provider, a pharmacy shall: (1) Maintain a permit from the Department pursuant to Health Occupations Article, Title 12, Annotated Code of Maryland, or from the appropriate agency in the state in which the pharmacy is located; (2) To the extent required by law, be licensed and legally authorized to practice or deliver services in the state in which the service is provided; and (3) Be a provider in the Maryland Medical Assistance Program. B. The Program shall reimburse for treatment directly related to a recipient's ESRD or a condition that is a direct result of the recipient's ESRD. C. The Program shall reimburse the incurred costs of prescription drugs and other pharmaceutical products determined to be medically necessary by the recipient's physician for treatment directly related to the recipient's ESRD or a condition that is a direct result of the recipient's ESRD. D. Before invoicing the Program, providers of Program-approved services shall first seek reimbursement from all other payment sources of the recipient including, but not limited to, insurance coverage, Medicare, Medical Assistance, and PAC. If the other sources reject a claim or pay less than the amount allowed by the Program, the provider may then submit the claim to the Program for review. E. A pharmacy provider may invoice the Program for reimbursement of legend drugs covered through the major medical component of a recipient's third-party insurance. The Program shall then seek reimbursement from the recipient's major medical coverage. F. When a recipient who is a Medicare beneficiary is provided a service that is covered by Medicare and the Program, Program payment shall be limited to payment of the recipient's Medicare deductible and co-insurance amounts. G. The Program may not reimburse for Medical Assistance covered services if the recipient is a Medical Assistance recipient. H. When a service is covered by a recipient's health insurance plan under which the provider agrees to accept payment by the health insurance plan as payment in full for the service, payment may not be made by the Program. I. The Program may not make a direct payment to a recipient. J. Program reimbursement for outpatient dialysis treatment shall be consistent with the limits established and rates paid by Medicare. K. Program reimbursement for other than outpatient dialysis treatment shall be consistent with the limits established and rates or fees paid by the Maryland Medical Assistance Program for the service except as otherwise indicated in this regulation. For services reimbursed on a fee basis, only the Medical Assistance net reimbursement amount will be paid. L. Reimbursement for preauthorized out-of-State renal transplantation services may not exceed rates paid for the same or similar services in Maryland. M. Program reimbursement for pharmacy services is as follows: (1) The Program shall only pay for legend drugs and diabetic supplies itemized on the Kidney Disease Program of Maryland Reimbursable Drug List; (2) A pharmacy provider shall charge the Program the provider’s usual and customary charge to the general public for legend drugs; (3) Drugs shall be reimbursed by the Program as follows: (a) Program payment for a legend drug shall be the lower of the provider's charge or the Medical Assistance allowable cost for the drug; (b) In addition to payment for the legend drug ingredient cost, the Program shall establish and pay a dispensing fee for legend drugs; (c) Duration of coverage for immunosuppressant drugs shall be consistent with Medicare policy; (d) The Program shall only pay for a generic equivalent unless a brand is specified as medically necessary by the prescribing physician; (e) The Program may not pay for more than a 34-day supply of an approved drug during a 26-day period; (f) The Program may not pay for replacement of lost medications; (g) The Program may pay for replacement of stolen medications when the claim is accompanied by a police report; (h) A pharmacy provider shall maintain on file a hard copy of each prescription filled for a recipient; and (i) The Program may not pay for legend drugs which are not FDA approved for the prescribed usage or which the FDA has declared to be “less-than-effective”. N. Reimbursement for Epogen (Epoetin alfa), dispensed as part of the dialysis procedure, shall be consistent with Medicare rates. Reimbursement shall be limited to dialysis facilities. O. Reimbursement for Procrit (Epoetin alfa) shall be consistent with Medicare rates. Coverage is limited to active renal transplant recipients. P. The Program shall provide reimbursement for access surgery required by a recipient for dialysis treatment even though the access surgery may predate the recipient's date of certification for Program benefits as established in accordance with Regulation .03 of this chapter. Q. To receive reimbursement from the Program a provider shall: (1) Accept payment by the Program as payment in full and make no additional charge to any person for services covered by the Program; (2) Provide services without regard to race, color, age, sex, national origin, marital status, or physical or mental handicap; (3) Verify the recipient's Program eligibility each time a service is provided by viewing the recipient's Kidney Disease Program identification card with a valid through date; (4) Notify the Program immediately of any recipient or provider activity or circumstance that affects eligibility, benefits, or reimbursement; (5) Maintain the confidentiality of all recipient information; (6) Submit the request for payment for services rendered according to procedures established by the Program and in the form designated by the Program; and (7) Maintain and make available administrative and medical records in accordance with the following requirements: (a) Administrative and medical records shall contain documentation that is sufficient in quantity, scope, and detail to confirm that services are provided in accordance with this chapter; (b) Records shall be maintained for a minimum of 6 years; and (c) Records shall be made available on request to the Department or the Department's designee. #### Regulation .08 Limitations. *COMAR 10.20.01.08* A. The Program does not cover a drug if: (1) The manufacturer has not provided the same rebate to the Kidney Disease Program as that provided for State-Only Pharmacy Assistance recipients’ purchases of drugs as is required under §1927(c) of Title XIX of the Social Security Act (42 U.S.C. §1396r-8(c)); (2) The Program has provided notice to the manufacturer of the manufacturer’s failure to provide adequate rebates and its opportunity to request a waiver from the rebate requirement under §A(3) of this regulation; and (3) The manufacturer has failed to demonstrate to the Secretary that the drug's availability is essential to Kidney Disease Program recipients. B. Effective April 4, 2012, a manufacturer or its designee may not dispute or request repayment of any rebate paid under §A(1) of this regulation more than 1 year after the date the rebate was paid. #### Regulation .09 Payment Procedures. *COMAR 10.20.01.09* A. A provider shall submit the request for Program payment for services rendered to a recipient according to procedures established by the Program and in the form designated by the Program. B. The Program reserves the right to return to the provider, before payment, all invoices not properly signed, completed, and accompanied by properly completed forms required by the Program. C. Billing Time Limits. (1) The Program may not make payments for an invoice that the Program receives more than 6 months from the date of service, except for an invoice first submitted to Medicare, a health insurer, or other third party for reimbursement. (2) For an invoice initially submitted to a third party for payment, the Program may not make payment unless the Program receives the invoice within 6 months of the date of service or 3 months of the third party's notification of payment action to the provider, whichever is later. (3) The Program shall make payment on a claim which the Program returns to the provider due to improper completion or incomplete information only if the claim is properly completed, resubmitted, and received by the Program within the original 6 months, or within 3 months of being returned, whichever is later. (4) If Medicare, or a third party rejects a provider’s claim because the claim was not received within the third party’s billing time limits, the Program may not make payment on that claim. (5) If the Program denies payment due to late billing, a provider may not recover the amount later from either the recipient or the Department. #### Regulation .10 Informal Reconsiderations and Hearings. *COMAR 10.20.01.10* A. Informal Reconsideration. (1) An applicant, recipient, or provider dissatisfied with a decision, action, or inaction of the Department under this chapter shall be granted an opportunity for an informal reconsideration of the matter. (2) The informal reconsideration shall include: (a) Written notice to the applicant, recipient, or provider of the decision or action taken by the Department and the basis for the decision or action; (b) If applicable, a written description of the basis for the Department's inaction; (c) A reasonable opportunity for the applicant, recipient, or provider to refute the basis of the Department's decision, action, or inaction; and (d) A written affirmation or reversal of the Department's decision, action, or inaction. (3) The opportunity to refute the Department's decision, action, or inaction specified in §A(2)(c) of this regulation may be provided: (a) In a meeting with a representative of the Program at the offices of the Program; (b) By telephone conference; or (c) In writing. B. Hearings. (1) The Department shall grant an opportunity for a hearing to an applicant or recipient who: (a) Is determined to be ineligible for benefits under the Program; (b) Is terminated from enrollment in the Program; or (c) Is otherwise denied benefits under the Program due to a decision, action, or inaction of the Department. (2) An applicant or recipient requesting a hearing shall notify the Department of the request within 30 days of the date of receipt of the notice of final decision or intended action by the Department. (3) Hearings shall be conducted in accordance with COMAR 10.01.03. #### Regulation .11 Program Recovery and Reimbursement. *COMAR 10.20.01.11* A. The Department shall seek recovery in all cases when Program benefits have been incorrectly paid. B. The Department shall accept reimbursement when voluntarily offered by a current or former recipient or someone acting on the recipient's behalf. C. The Department may institute any proceedings that the Department considers necessary to require collection of uncollected fees. D. The Program shall refer to the Central Collection Unit in the Department of Budget and Fiscal Planning for investigation and other appropriate action all cases in which a recipient has received coverage erroneously as a result of the action or inaction of the recipient. E. The Department shall investigate and take appropriate action in all cases in which eligibility has been incorrectly established as a result of the action or inaction of a recipient, representative, or person acting responsibly for the recipient. F. The Program shall require a recipient to authorize the release to the Department of all data, records, and information by insurance companies, nonprofit health service plans, providers of medical care, employers, unions, governmental agencies, and any other agencies, organizations, or individuals necessary for the Department's pursuit of third-party reimbursement. The authorization extends to all information relevant to third-party reimbursement or third-party health care coverage. G. The Department shall collect available benefits from third parties determined liable to pay for services received under the Program. H. A recipient who receives medical services that were or will be paid for by the Program is considered to have made assignment to the Department of the: (1) Recipient's rights to any third-party payments for medical care; and (2) Rights of any other individual eligible under the plan, for whom the recipient can legally make an assignment. I. The assignment created under §H of this regulation shall be effective as long as the recipient is enrolled in the Program and remains effective for all services paid by the Program during this period of enrollment, and for those services which were erroneously provided to ineligible persons and paid for by the Program. J. If a recipient dies, the Department may make a claim against the estate of the recipient for any unpaid fee established for that recipient in accordance with the following: (1) Except as provided in §J(4) of this regulation, a claim shall not be made for any fee for services provided more than 3 years before the recipient died; (2) A claim under this section is a preferred claim against the estate of a deceased recipient; (3) The claim may be waived by the Department if, in the Department's judgment, enforcement of the claim will cause substantial hardship to dependents of the deceased; and (4) If a responsible relative who is liable for the cost of care of the recipient has misrepresented assets or submitted fraudulent information and, by doing so, has avoided any part of the claim for the cost of care, there is no limitation on the time in which the claim may be brought against the estate. #### Regulation .12 Conflict with Regulations of the Kidney Disease Commission. *COMAR 10.20.01.12* Pursuant to Health-General Article, §13-308(e), Annotated Code of Maryland, the Department is authorized, after consulting with the Commission, to adopt these regulations. Accordingly, these regulations supersede any regulations issued by the Commission that concern nonmedical issues. ## Subtitle 21 — Behavioral Health Regulations ### Chapter 01 — Involuntary Admission to Inpatient Mental Health Facilities **Authority:** Health-General Article, §§7.5-204 — 7.5-205, 10-603, 10-615 — 10-616, 10-619 and 10-806(d)(3), Annotated Code of Maryland **Administrative History:** Effective date: December 5, 1970 **Administrative History:** Amended effective October 1, 1973 **Administrative History:** Chapter revised effective October 12, 1981 (8:20 Md. R. 1635) **Administrative History:** Annotation: COMAR 10.21.01.04B and .07E cited in Attorney General Opinion No. 86-031 (May 12, 1986) **Administrative History:** Regulations .01 — .10 repealed and new Regulations .01 — .11 adopted effective September 28, 1992 (19:19 Md. R. 1708) **Administrative History:** Regulation .02 amended effective September 13, 1993 (20:18 Md. R. 1430) **Administrative History:** Regulation .02B amended effective March 28, 2016 (43:6 Md. R. 409); January 2, 2017 (43:26 Md. R. 1445) **Administrative History:** Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .04B amended effective January 2, 2017 (43:26 Md. R. 1445) **Administrative History:** Regulation .08C amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .09 amended effective September 13, 1993 (20:18 Md. R. 1430) **Administrative History:** Regulation .10 amended effective March 28, 2016 (43:6 Md. R. 409) #### Regulation .01 Scope. *COMAR 10.21.01.01* A. This chapter governs the procedure for the involuntary admission of individuals to inpatient mental hygiene facilities, including State facilities, private psychiatric facilities, acute general hospitals with inpatient psychiatric units, and Veterans' Administration hospitals pursuant to Health-General Article, §§10-603, 10-613 — 10-617, 10-620, 10-631 — 10-633, and 10-803— 10-806, Annotated Code of Maryland. B. This chapter is not intended to impose any exhaustion requirement upon an individual as a prerequisite to the individual's pursuing concurrently or in any order any available legal remedy to obtain release from an inpatient facility. #### Regulation .02 Definitions. *COMAR 10.21.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Behavioral Health Administration. (2) “Administrative law judge (ALJ)” means an individual in the Office of Administrative Hearings who is authorized under State Government Article, §9-1604, Annotated Code of Maryland, to conduct hearings under this chapter. (3) “Application for involuntary admission (Application for IVA)” means the application required under Health-General Article, §§10-614 and 10-615, Annotated Code of Maryland, to initiate the IVA of an individual to an inpatient facility. (4) “Change of status hearing” means the IVA hearing that is convened when appropriate staff at an inpatient facility complete the application and certificates for IVA on behalf of an individual who is voluntarily admitted or court-ordered to the inpatient facility. (5) “Department” means the Maryland Department of Health. (6) “Discharge” means authorization by a physician for a voluntarily or involuntarily admitted individual to leave an inpatient facility. (7) “Discharge summary” means a written evaluation by a physician that includes, at a minimum, the individual's diagnoses, summary of the treatment provided and progress during the current stay at the discharging inpatient facility, current mental status, prescribed medications, and treatment recommendations. (8) “Geriatric Evaluation Services (GES)” means the staff of the county health departments that evaluate the appropriateness of admissions to State facilities or Veterans' Administration hospitals of individuals 65 years old or older. (9) “Indigent” means that an individual has neither sufficient property to support the individual nor anyone able to support the individual to whom the individual is entitled to look for support. (10) “Individual treatment plan (ITP)” means a treatment plan prepared for an individual in an inpatient facility according to the requirements outlined in Health-General Article, §10-706, Annotated Code of Maryland, and COMAR 10.21.03. (11) Inpatient Facility. (a) “Inpatient facility” means an inpatient institution that provides evaluation, care, or treatment for individuals who have mental disorders. (b) “Inpatient facility” includes a Veterans' Administration (VA) hospital. (12) “Involuntary admission (IVA)” means that an individual has been admitted to an inpatient facility by an ALJ following an IVA hearing pursuant to Health-General Article, §10-632, Annotated Code of Maryland. (13) “Involuntary admission hearing (IVA hearing)” means an administrative proceeding at which an administrative law judge determines whether an individual who has been confined in an inpatient facility on the basis of application and certificates for IVA is retained as an inpatient or released from the inpatient facility without being admitted. (14) “Medical clearance” means that an individual has been evaluated by a physician, a physician's assistant, or a nurse practitioner, and the evaluator has confirmed with the receiving inpatient facility that the receiving facility has the capacity to provide the necessary and appropriate medical management of the individual. (15) “Medical record” means a record as defined in Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. (16) Mental Disorder. (a) “Mental disorder” means a behavioral or emotional illness that results from a psychiatric or neurological disorder. (b) “Mental disorder” includes a mental illness that substantially impairs the mental or emotional functioning of an individual so as to make care or treatment necessary or advisable for the welfare of the individual or for the safety of the person or property of another. (c) “Mental disorder” does not include mental retardation or a primary diagnosis of alcohol or drug abuse. (17) “Nolle pros” means “nolle prosequi” as set forth in Maryland Rule 4-247. (18) “Observation status” means the status of an individual between the time the individual is initially confined in an inpatient facility on the basis of application and certificates for IVA and the time the individual is either admitted, voluntarily or involuntarily, to the inpatient facility or is released by a physician or by an ALJ from the inpatient facility without being admitted. (19) “Office of Administrative Hearings (OAH)” means the office created under State Government Article, §9-1602, Annotated Code of Maryland. (20) “Office of the Public Defender (OPD)” means the office created under Article 27A, Annotated Code of Maryland. (21) “Party” means the inpatient facility or the individual for whom an IVA hearing has been convened. (22) “Petition for emergency evaluation” means a petition filed under the provisions of Health-General Article, §§10-620 — 10-629, Annotated Code of Maryland, to initiate the evaluation of an individual in an emergency facility that is designated by the Department, under the provisions of Health-General Article, §10-621, Annotated Code of Maryland, to perform emergency psychiatric evaluations. (23) “Physician” means an individual who is licensed under Health Occupations Article, Title 14, Annotated Code of Maryland, to practice medicine in this State or, if the individual is working in a Veterans' Administration Hospital, authorized by the U.S. Department of Veterans' Affairs to practice medicine. (24) “Physician’s, psychologist’s, or psychiatric nurse practitioner’s certificate” means the certificate completed according to the provisions of Health-General Article, §§10-616 — 10-617, Annotated Code of Maryland. (25) “Presenter” means the individual, including an assistant attorney general, designated by the chief executive officer of an inpatient facility, who acts on behalf of the inpatient facility at an IVA hearing. (26) “Psychiatric nurse practitioner” means an individual licensed under Health-Occupations Article, Title 8, Annotated Code of Maryland, to practice nursing in this State as a certified registered nurse practitioner-psychiatric mental health (CRNP-PMH). (27) “Psychiatrist” means a physician who is identified as a specialist in psychiatry by the Board of Physician Quality Assurance or, if the physician is working in a Veterans' Administration Hospital, by the U.S. Department of Veterans' Affairs. (28) “Psychologist” means an individual who is: (a) Licensed under Health Occupations Article, Title 18, Annotated Code of Maryland, to practice psychology or, if the individual is working in a Veterans' Administration Hospital, authorized by the U.S. Department of Veterans' Affairs to practice psychology; and (b) Listed in the National Register of Health Service Providers in Psychology. (29) “Release” means the authorization for an individual who is confined in an inpatient facility on the basis of application and certificates for IVA to leave the inpatient facility: (a) Given by a physician during the observation status period; or (b) Ordered by an ALJ at an IVA hearing. (30) “Secretary” means the Secretary of Health. (31) “Semiannual hearing” means the hearing that is held not sooner than 5 months or later than 6 months following an involuntarily admitted individual's last IVA hearing. (32) “State inpatient facility” means an inpatient institution that is owned or operated by the State and that provides evaluation, care, or treatment for individuals who have mental disorders. (33) “Stet” means the postponement of a trial pursuant to Maryland Rule 4-248. (34) “Voluntary admission” means that an individual has been admitted to an inpatient facility on the basis of: (a) A signed and endorsed formal application for voluntary admission pursuant to Health-General Article, §10-609 or 10-610, Annotated Code of Maryland; (b) An informal request for admission pursuant to Health-General Article, §10-609, Annotated Code of Maryland; or (c) If the voluntary admission is to a VA hospital, the procedure established by the VA hospital. (35) “Working day” means any day except Saturday, Sunday, or a holiday on which State offices are closed. #### Regulation .03 Application for Involuntary Admission (IVA). *COMAR 10.21.01.03* A. An applicant for IVA shall: (1) Have a legitimate interest in the welfare of the individual for whom IVA is sought; (2) Submit an application on the form required by: (a) The Veterans' Administration, if the application is submitted to a Veterans' Administration hospital; or (b) The Administration, if the application is submitted to an inpatient facility other than a Veterans' Administration hospital; (3) Fill out the appropriate form completely; and (4) Sign and date the application form. B. The Administration shall provide an application form that includes the following: (1) The statutory authority for the application; (2) The form number (MDH34) and revision date; (3) Spaces for the: (a) Name of the inpatient facility to which the application for IVA is submitted; (b) Name of the individual for whom IVA is sought; (c) Name, home or agency address, telephone number, and relationship to the individual or official capacity of the applicant; and (d) Signature of the applicant and the date that the application is made. #### Regulation .04 Physician’s, Psychologist’s or Psychiatric Nurse Practitioner’s Certificate for Involuntary Admission (IVA). *COMAR 10.21.01.04* A. The following shall be submitted when initiating the IVA of an individual: (1) An application for IVA completed under the provisions of Regulation .03 of this chapter; and (2) A certificate completed by: (a) Two physicians; (b) One physician and one psychologist; or (c) One physician and one psychiatric nurse practitioner. B. The Secretary shall provide the certificate that includes the following: (1) The statutory authority for the certificate; (2) The form number (MDH2) and revision date; (3) A list of the appropriate documentation that shall be attached to one of the certificates; (4) A statement that the certificate may not be used for the IVA of an individual if the examination on which the certificate is based was done: (a) More than 1 week before the certificate is signed; or (b) More than 30 days before the inpatient facility or the Veteran’s Administration hospital receives the application for admission; (5) A list of the State inpatient facilities and the catchment areas from which each facility accepts referrals; (6) Spaces for the following information: (a) The name, address, and telephone number of the certifying physician, psychologist, or psychiatric nurse practitioner; (b) The name, address, identifying data, and the next of kin of the individual for whom the certificate is made; (c) The date that the physician, psychologist, or psychiatric nurse practitioner examined the individual; (d) A diagnosis of a mental disorder of the individual; (e) An opinion that: (i) The individual needs inpatient care or treatment; and (ii) Admission to an inpatient facility is needed for the protection of the individual or another; and (f) The individual's: (i) Current medications; and (ii) Emergency medications; (7) A statement of whether the individual who completes the certificate is a physician, psychologist, or psychiatric nurse practitioner; (8) The statement that the physician, psychologist, or psychiatric nurse practitioner: (a) Has no financial interest, through ownership or compensation, in a proprietary inpatient facility, and admission to that proprietary inpatient facility is sought for the individual whose status is being certified; and (b) Is not related, by blood or marriage, to the individual or to the applicant; and (9) Space for the signature of the physician, psychologist, or psychiatric nurse practitioner and for the date and time the certificate is signed. C. To complete a certificate for IVA, a physician, psychologist, or psychiatric nurse practitioner shall: (1) Personally examine an individual for whom an application for IVA has been completed under the provisions of Regulation .03 of this chapter; (2) Completely fill out the form described under §B of this regulation; (3) Sign, date, and time the certificate not later than 1 week following the examination required under §C(1) of this regulation; and (4) Attach to one of the certificates for IVA copies of any available current medical reports or records that support the individual's need for involuntary care or treatment in an inpatient facility, with reports including at a minimum: (a) The diagnosis of mental disorder, current symptoms, and psychiatric history; (b) A summary of the medical history, including documentation of medical clearance; (c) An explanation of why the individual meets the following requirements for IVA: (i) The individual has a mental disorder; (ii) The individual needs inpatient care or treatment; (iii) The individual presents a danger to the life or safety of the individual or of others; (iv) The individual is unable or unwilling to be admitted voluntarily; (v) There is no available, less restrictive form of intervention that is consistent with the welfare and safety of the individual; and (vi) Unless the individual is an emergency evaluee, if the individual is 65 years old or older and is being referred for admission to a State inpatient facility or a VA hospital, a GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual; (d) If the individual is an emergency evaluee, a copy of the petition for emergency evaluation; and (e) If the individual is discharged from an inpatient facility after appropriate staff at the inpatient facility have completed application and certificates for IVA to initiate the direct confinement of the individual in another inpatient facility: (i) The information outlined in §C(4)(a) — (d) of this regulation; (ii) The discharge summary; (iii) A copy of the individual's most recent ITP completed in accordance with Health-General Article, §10-706, Annotated Code of Maryland, and COMAR 10.21.03; and (iv) Copies of all voluntary and involuntary admissions documents relating to the current admission at the inpatient facility from which the individual is discharged. D. An inpatient facility may not use for the admission of an individual a certificate that: (1) Is based on an examination that was done: (a) More than 1 week before the certificate is signed; or (b) More than 30 days before the inpatient facility receives the application for admission; or (2) Was previously used in connection with the taking into confinement on observation status an individual who subsequently was admitted to or released or discharged from an inpatient facility. #### Regulation .05 Notice of Status and Rights. *COMAR 10.21.01.05* A. If an individual is confined on observation status in an inpatient facility on the basis of an application and certificates for IVA, staff at the inpatient facility shall inform the individual of the individual's status and rights: (1) By giving the individual the Notice of Status and Rights form described under §C of this regulation and provided by the Administration; (2) By explaining the information on the form to the individual in English or in the language and terms that are appropriate to the individual's condition and ability to understand; and (3) At the following times: (a) Within 12 hours of the individual's initial confinement in an inpatient facility on the basis of application and certificates for IVA under the provisions of Regulations .03 and .04 of this chapter; (b) When certificates for IVA are executed for the purpose of changing the individual's status in accordance with Regulation .08B of this chapter; and (c) When certificates are executed for the purpose of recertifying the individual for a semiannual hearing in accordance with Health-General Article, §10-806(d), Annotated Code of Maryland, and Regulation .08C of this chapter. B. Staff shall file a copy of the Notice of Status and Rights form in the individual's medical record and give copies to: (1) When possible, the individual's parent, guardian, or next of kin; and (2) If the individual does not understand the notice, the individual's: (a) Parent, guardian, or next of kin; (b) The applicant for IVA; and (c) Any other person who has significant interest in the status of the individual. C. The Administration shall provide a Notice of Status and Rights form that includes the following: (1) The statutory authority for the notice; (2) The form number (MDH33) and revision date; (3) A statement of the rights provided under Health-General Article, §10-631, and Title 10, Subtitle 7, Annotated Code of Maryland; (4) The right and access to legal counsel provided under Health-General Article, §10-631(a)(2) — (4), Annotated Code of Maryland; (5) The hearing rights enumerated under Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09C of this chapter; (6) The right to request a judicial hearing on the cause and legality of the individual's admission and continued detention according to Health-General Article, §§10-804 and 10-805, Annotated Code of Maryland; and (7) Spaces for: (a) The name of the individual; (b) The name of the inpatient facility; (c) The basis for the individual's status and the provisions of law pertaining to the status; (d) The signature of the individual and date that the individual received the notice; (e) An explanation, if the individual does not sign the notice; (f) An indication of whether the notice is given to a parent, guardian, or next of kin; (g) An indication of whether the individual understands the notice; and (h) Signature of inpatient facility staff who gives the notice to the individual and date that the notice is given. #### Regulation .06 Notice of Hearing. *COMAR 10.21.01.06* A. Staff at an inpatient facility shall inform an individual of the individual's right to an IVA hearing in accordance with the requirements for providing Notice of Status and Rights delineated in Regulation .05 of this chapter. B. Staff shall give the Notice of Hearing: (1) Orally; and (2) On the form provided by the OAH which shall include: (a) The date, time, and place that the hearing will be held; (b) The legal authority for and purpose of the hearing; (c) A short statement explaining why the individual's involuntary admission is being sought; (d) The standards delineated in Health-General Article, §10-632, Annotated Code of Maryland, that govern whether the individual shall be involuntarily admitted; (e) Notice of the individual's right to consult with an attorney of the individual's choice and, if the individual is unable to afford an attorney, the availability of representation at the hearing through the Office of the Public Defender, Mental Health Division; and (f) A list of the individual's rights at a hearing as set forth in Regulation .09C of this chapter. C. Staff shall file a copy of the Notice of Hearing form in the individual's medical record and give a copy to the individual's parent, guardian, or next of kin. #### Regulation .07 Observation Status. *COMAR 10.21.01.07* A. Upon a properly executed application executed in accordance with Regulation .03 of this chapter and certificates for IVA and all required attachments in accordance with Regulation .04 of this chapter, an inpatient facility that accepts individuals who are referred for IVA may take an individual into confinement on observation status. B. GES Evaluation. If an individual is an emergency evaluee, and the individual is 65 years old or older, on the first working day after the individual is taken into confinement on observation status, staff at a State inpatient facility or Veterans' Administration hospital shall: (1) Notify the GES team in the county where the individual resides; and (2) Document whether the GES grants clearance for the involuntary admission of the individual. C. Examination. (1) A psychiatrist shall examine an individual if the individual remains confined on observation status in an inpatient facility within 24 hours of the initial confinement. (2) If a physician who examines an individual confined on observation status determines that the individual does not meet the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c) of this chapter, the physician shall: (a) If the individual meets the requirements for voluntary admission, offer the individual an application for voluntary admission; or (b) Immediately release the individual, following: (i) Notification to the parent or guardian that the individual is being released, if the individual is a minor or is a disabled adult who is under guardianship of the parent or guardian under the provisions of Estates and Trusts Article, §13-708, Annotated Code of Maryland; and (ii) Preparation of a written aftercare plan in accordance with Health-General Article, §10-809, Annotated Code of Maryland. D. Medical Records. (1) An inpatient facility shall maintain the medical records for individuals who are confined on observation status separate from the inpatient medical records of the facility. (2) The inpatient facility may not disclose an individual's observation status medical record in any way that would indicate that the individual had been present in the inpatient facility, except: (a) For the sole purposes of: (i) Providing notice of admission status and rights and notice of hearing to the individual's parent, guardian, or next of kin, in accordance with Regulations .05 and .06 of this chapter; (ii) Calling witnesses to testify at the individual's IVA hearing; and (iii) Fulfilling the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; or (b) Upon the authorization of the individual. (3) Staff at the inpatient facility where an individual is confined may use prior observation status medical records, as necessary, to provide for the proper care or treatment of the individual. E. Rights. An individual who is confined on observation status in an inpatient facility shall be entitled to the rights granted in accordance with Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland. F. An individual taken into an inpatient facility in accordance with §A of this regulation shall remain confined on observation status until the individual is: (1) Voluntarily admitted to the inpatient facility in accordance with the provisions of Health-General Article, §10-609 or 10-610, Annotated Code of Maryland, and if the individual is: (a) A minor, a parent or guardian who is not a representative of a State agency signs an application for voluntary admission of a minor, in accordance with Health-General Article, §10-610, Annotated Code of Maryland; (b) A minor who is confined in a State inpatient facility, a parent or guardian has not previously executed an application for voluntary admission of a minor during the minor individual's current confinement in the State inpatient facility; and (c) Not a disabled adult who is under guardianship of the person under the provisions of Estates and Trusts Article, §13-708, Annotated Code of Maryland; (2) Released by a physician of the inpatient facility before the scheduled IVA hearing pursuant to §C(2)(b) of this regulation; (3) Admitted to the inpatient facility by an ALJ following an IVA hearing in accordance with Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09G of this chapter; or (4) Released from the inpatient facility by an ALJ following an IVA hearing in accordance with Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09G of this chapter. G. Discharge of an Individual on Observation Status and Referral for Direct IVA at Another Inpatient Facility. An inpatient facility may refer for IVA to another inpatient facility an individual who is confined on observation status only if the receiving inpatient facility agrees to have the hearing held within 10 days of the individual's initial confinement in the discharging inpatient facility on the basis of application and certificates for IVA. H. Payment or Reimbursement for Care or Treatment. Payment or reimbursement for care or treatment of an individual who is confined on observation status in, or who is involuntarily admitted to, an inpatient facility shall be in accordance with the provisions of Health-General Article, Title 16, Subtitle 2, Annotated Code of Maryland. #### Regulation .08 Schedule of IVA Hearings. *COMAR 10.21.01.08* A. Initial Hearing. (1) When an individual is confined on observation status in an inpatient facility on the basis of application and certificates for IVA, inpatient facility staff shall: (a) Schedule a hearing to take place within 10 days of the individual's initial confinement in the inpatient facility; (b) Notify the OAH and the OPD that the hearing has been scheduled; and (c) Give the Notice of Status and Rights in accordance with Regulation .05 of this chapter, and Notice of Hearing in accordance with Regulation .06 of this chapter. (2) The ALJ may postpone the hearing for good cause or by agreement of the parties, and the postponement shall be: (a) For not more than 7 days; (b) On the record; and (c) One time only. B. Change of Status Hearing. (1) An inpatient facility that accepts individuals who are referred for IVA may initiate the procedure outlined in this section to change the admission status of an individual when, in the clinical judgment of the individual's treating physician, the individual meets the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c) of this chapter, and the individual is: (a) Admitted voluntarily pursuant to Health-General Article, §10-609, Annotated Code of Maryland, and the individual requests discharge or otherwise demonstrates that the individual is unwilling or unable to continue to agree to voluntary treatment; (b) A minor who is admitted on the basis of an application for voluntary admission of a minor signed by the parent or guardian, pursuant to Health-General Article, §10-610, Annotated Code of Maryland, and the: (i) Parent or guardian requests release of the minor; or (ii) Minor has been admitted to a State inpatient facility, and the minor is in need of care or treatment for longer than 20 days; or (c) Admitted on the basis of a court order pursuant to Health-General Article, §12-104 or 12-110, Annotated Code of Maryland, and the Office of the State's Attorney or the court has agreed to dismiss, nolle prosequi, or stet the charges. (2) Two physicians or one physician and one psychologist shall evaluate the individual and, if the individual meets the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c) of this chapter, shall submit an application for IVA of the individual in accordance with the provisions of Regulation .03 of this chapter and complete certificates for IVA in accordance with the provisions of Regulation .04 of this chapter: (a) Within 3 days of the request for discharge, if the individual was admitted on the basis of a formal, written application for voluntary admission; (b) Before 4 p.m. on the day of the request for discharge, if the individual was admitted voluntarily on the basis of an informal request; (c) Before the expiration of the 20-day maximum stay, if the individual is a minor who was admitted to a State inpatient facility on the basis of an application for voluntary admission signed by the parent or guardian; and (d) By the close of business of the next working day following official notification that the charges have been dismissed, nolle prossed, or stetted. (3) Following completion of the application and certificates for IVA under §B(2) of this regulation, staff at the inpatient facility shall: (a) Schedule a hearing to take place within 10 days of the completion of application and certificates for IVA in accordance with §B(2) of this regulation; (b) Notify the OAH and the OPD that the hearing has been scheduled; (c) Give the Notice of Status and Rights in accordance with Regulation .05 of this chapter, and Notice of Hearing pursuant to Regulation .06 of this chapter; and (d) If the individual is 65 years old or older and is in a State inpatient facility or Veterans' Administration hospital, and during the individual's current stay in the State facility or Veterans' Administration hospital the individual has not been approved for IVA by the GES: (i) Notify the GES in the county of the individual's last residence that application and certificates for IVA have been completed; and (ii) Document that the GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual. (4) If an inpatient facility does not accept individuals who are referred for IVA, and an individual is admitted voluntarily, pursuant to Health-General Article, §10-609, Annotated Code of Maryland, if the individual requests to be discharged from the inpatient facility or otherwise demonstrates that the individual is unwilling or unable to continue to agree to voluntary treatment, before discharging the individual, staff at the inpatient facility: (a) May initiate the procedure outlined in §B(2) of this regulation and arrange to refer the individual to an inpatient facility that accepts individuals who are referred for IVA; and (b) Shall assure that a hearing shall be held at the receiving inpatient facility within 10 days of completion of application and certificates for IVA in accordance with §B(2) of this regulation. C. Semiannual Hearing. (1) Facility staff shall schedule a hearing for the purpose of determining whether an individual continues to meet the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c)(i) — (v) of this chapter: (a) Not sooner than 5 months or later than 6 months from the date that the individual is involuntarily admitted to an inpatient facility following an IVA hearing in accordance with §A or B of this regulation; and (b) Semiannually after that. (2) At least 7 days before the date a semiannual hearing is scheduled to take place: (a) Two physicians or one physician and one psychologist or one physician and one psychiatric nurse practitioner shall complete certificates for IVA in accordance with the provisions of Regulation .04 of this chapter; (b) Staff at the inpatient facility shall give the Notice of Status and Rights in accordance with Regulation .05 of this chapter, and Notice of Hearing pursuant to Regulation .06 of this chapter; (c) Staff at the inpatient facility shall notify the OAH and the OPD that a hearing has been scheduled; and (d) If the individual is 65 years old or older and is in a State inpatient facility or Veterans' Administration hospital, and during the individual's current stay in the State inpatient facility or Veterans' Administration hospital the individual has not been approved for IVA by the GES, State inpatient facility or Veterans' Administration hospital staff shall: (i) Notify the GES in the county of the individual's last residence that certificates for IVA have been completed; and (ii) Document that the GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual. (3) A parent or guardian of a minor individual may not execute an application for voluntary admission of the minor at the time that a semiannual hearing is scheduled for the minor. #### Regulation .09 Conduct of IVA Hearings. *COMAR 10.21.01.09* A. Powers and Duties of ALJ. An ALJ from the OAH shall conduct a hearing at the inpatient facility according to the rules of procedure outlined in COMAR 28.02.01. B. Location. Unless the ALJ, for good cause, relocates a hearing, the hearing shall take place in the inpatient facility where the individual is confined, and the inpatient facility shall provide a room that: (1) During the hearing, is used for no other purpose; (2) Has sufficient space and adequate and appropriate furnishings to accommodate the ALJ, the parties, and any others participating in the hearing; and (3) Includes a speaker telephone that is adequate for the purpose of taking testimony by telephone. C. Rights of Parties. (1) At a hearing, the parties have the right to: (a) Be represented by counsel; (b) Present witnesses; (c) Cross-examine witnesses presented by the other party; (d) Present documentary or other relevant evidence; (e) Submit rebuttal evidence; and (f) Present summation and argument. (2) In addition, an individual has the right to: (a) Wear the individual's own clothes; and (b) Be present or waive the right to be present, if the waiver is: (i) Knowingly and intelligently made; (ii) Witnessed by the individual's counsel; and (iii) Witnessed by the ALJ. D. Record of Hearing. (1) The ALJ shall make and maintain a record of the hearing, and the record shall: (a) Be an audio recording of the oral proceedings before the ALJ; (b) Include a full description of the documentary evidence submitted at the hearing, but may not include the physical evidence itself; (c) Be maintained for a period of 3 years following the hearing; and (d) Upon request, be made available to a party to the hearing or to a party's counsel or authorized representative to listen to the record. (2) Upon request by a party to the hearing, the OAH shall transcribe the record, and the record shall be: (a) Paid for by the requesting party in accordance with the charges established in State Government Article, §10-621, Annotated Code of Maryland, and COMAR 10.01.08.14; or (b) Provided without cost to an individual who: (i) Has filed an appeal in proper person; and (ii) Is indigent. E. Testimony. (1) The ALJ shall require the inpatient facility to provide for the testimony of one of the following, who has personally examined the individual within 48 hours before the hearing: (a) A psychiatrist; (b) A physician in an accredited residency program in psychiatry if the physician in the residency program in psychiatry is under the supervision of the psychiatrist who is responsible for the treatment of the individual who is the subject of the hearing; or (c) A psychologist. (2) Unless the inpatient facility demonstrates exceptional and compelling circumstances, the ALJ shall require the examining psychiatrist, physician in the residency program in psychiatry identified under §E(1)(b) of this regulation, or psychologist, to testify in person at the hearing. (3) If the ALJ determines that a certifying physician or, psychologist, has not submitted adequate information with the certificate and that additional testimony from the certifying physician or, psychologist, may materially assist the ALJ to make an informed decision, the ALJ may; (a) Require the certifying physician or, psychologist, to attend and testify at the hearing; or (b) Receive the testimony of the certifying physician or, psychologist, by telephone. F. Burden of Proof. The burden of proof is on the inpatient facility to demonstrate by clear and convincing evidence that: (1) The individual has a mental disorder; (2) The individual needs inpatient care or treatment; (3) The individual presents a danger to the life or safety of the individual or of others; (4) The individual is unable or unwilling to be admitted voluntarily; (5) There is no available, less restrictive form of intervention that is consistent with the welfare and safety of the individual; and (6) If the individual is 65 years old or older and is being referred for admission to a State inpatient facility or VA hospital, a GES team has determined that there is no available, less restrictive form of care or treatment that is adequate for the needs of the individual. G. Findings and Conclusions. After the evidence and testimony are presented, and following summation and argument by the parties, the ALJ shall: (1) Consider all evidence and testimony of record; (2) Rule on issues raised by the individual that relate to the process by which the: (a) Individual was taken into and confined during observation status; (b) Individual's admission status was changed according to the provisions of Regulation .08B of this chapter; or (c) Individual is presented for a semiannual hearing under the provisions of Regulation .08C of this chapter; (3) Order the release of the individual from the inpatient facility if: (a) An error in the process occurred; (b) The error in the process is substantial; and (c) No other available remedy is consistent with due process and the protection of the individual's rights; (4) Order the release of the individual from the inpatient facility unless the inpatient facility meets the burden of proof outlined in §F of this regulation; (5) State on the record the: (a) Findings, including whether the individual waived the right to attend the hearing; (b) Conclusions of law on any relevant issue presented; (c) Right of the individual to appeal the decision of the ALJ pursuant to State Government Article, §§10-215 and 10-216, Annotated Code of Maryland, and the procedure for requesting an appeal; and (d) Right of the individual to seek judicial release from the inpatient facility pursuant to the provisions of Health-General Article, §§10-804 and 10-805, Annotated Code of Maryland; and (6) Give to the individual a written decision which shall: (a) Be on the form provided by the OAH; (b) Include the conclusions and the rights enumerated under §G(5) of this regulation; (c) State whether the inpatient facility has proven that the individual meets each of the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and §F of this regulation; and (d) By copy, be: (i) Given to the presenter; (ii) Filed in the individual's medical record; and (iii) If the individual is a minor, given to the individual's parent or guardian if the parent or guardian is present at the hearing. #### Regulation .10 Evaluation Following ALJ Release. *COMAR 10.21.01.10* If an individual is released from an inpatient facility by an ALJ under the provisions of Regulation .09G(3) of this chapter, and the individual’s treating physician, psychologist, or psychiatric nurse practitioner determines, based on the individual’s behavior and clinical condition after the hearing, that the individual meets the requirements for IVA outlined in Health-General Article, §10-617, Annotated Code of Maryland, and Regulation .04C(4)(c)(i) — (v) of this chapter: A. After the individual has been given the opportunity to leave the inpatient facility, the treating physician, psychologist, or psychiatric nurse practitioner may file a petition for emergency evaluation as the means of initiating an emergency psychiatric evaluation; and B. The inpatient facility may not accept the application and certificates for IVA that initiated the individual's initial confinement under Regulation .07A of this chapter for the purpose of taking the individual into confinement on observation status following the release. #### Regulation .11 Discharge of an Involuntarily Admitted Individual and Referral for IVA in Another Inpatient Facility. *COMAR 10.21.01.11* Unless an individual is discharged from one State inpatient facility and referred for IVA in another State inpatient facility: A. When an inpatient facility discharges an individual who has been involuntarily admitted pursuant to Health-General Article, §10-632, Annotated Code of Maryland, and Regulation .09G of this chapter, and refers the individual for IVA in another inpatient facility, appropriate staff at the discharging inpatient facility shall: (1) Complete an application and certificates for IVA, including the required documentation outlined in Regulation .04C(4) of this chapter; and (2) On or before the date of the referral for IVA, provide all the records necessary for the continuing care or treatment of the individual pursuant to Health-General Article, §§4-306(a)(5), 4-307(h)(1)(i), 10-807(d), and 19-308.2, Annotated Code of Maryland. B. Upon arrival of an individual who is referred for IVA and receipt of the documentation listed in §A of this regulation, the receiving inpatient facility shall: (1) Take the individual into observation status in accordance with Regulation .07 of this chapter; and (2) Schedule an IVA hearing in accordance with the provisions of Regulation .08A of this chapter. ### Chapter 02 — Psychiatric Day Treatment Services **Authority:** Health-General Article, §2-104, Annotated Code of Maryland **Administrative History:** Effective date: November 25, 1961 **Administrative History:** Amended effective August 4, 1965 and April 15, 1974 **Administrative History:** Chapter revised effective May 29, 1981 (8:11 Md. R. 974) #### Regulation .01 Definitions. *COMAR 10.21.02.01* A. “Adolescents” means persons 13 to 18 years old. B. “Board” means the executive authority and policy-making group which operates a psychiatric day treatment center for mentally ill persons. C. “Children” means persons younger than 13 years old. D. “Consumer” means a person who has received or is receiving services in any program, public or private, providing mental health services or is the relative of a person receiving or having received these services. E. “Full treatment day” for the purposes of these regulations means 6-1/2 hours. The minimum unit of service or half treatment day is 4 consecutive hours. F. “Health authority” means the Maryland Department of Health or a designated local health officer. G. “Psychiatric day treatment center” means the premises on which psychiatric day treatment is provided. H. “Psychiatric day treatment services” means intensive, nonresidential psychiatric treatment for any part of a 24-hour day for a minimum of 4 consecutive hours per day. Patients admitted to these services are those for whom at the time of admission, it is reasonable to anticipate that maximum day treatment benefits would be achieved within 30 full treatment days. If at any point in the course of treatment it is believed that patients would benefit from additional intensive treatment, beyond the 30-day period, continued day treatment may be provided, but the record shall document justification for the continued intensive treatment. Day treatment services provide flexible scheduling to meet the needs of the individual patient so that the 30 treatment days may nor may not be consecutive. The services given may be part of a psychiatric hospital program, or a psychiatric unit of a general hospital, or a free-standing community-based mental health program which has an arrangement for appropriate support services with a licensed general hospital or a licensed psychiatric hospital. Psychiatric day treatment services provide active psychiatric treatment. Psychiatric day treatment services do not provide residential care, nor are they identical with socializing and activity programs, recreational community programs, or day care facilities which do not provide active psychiatric treatment. #### Regulation .02 General Provisions. *COMAR 10.21.02.02* A. Program Approval. Psychiatric day treatment services which are under the auspices of a psychiatric unit located in a licensed psychiatric hospital or under the auspices of a psychiatric unit of a licensed acute general hospital shall be reviewed and approved by the Mental Hygiene Administration on the basis of these regulations. Free-standing psychiatric day treatment services and those under the auspices of a community mental health program shall also be reviewed and approved by the Mental Hygiene Administration on the basis of these regulations. B. Standards for Psychiatric Day Treatment Services. (1) The daily treatment program shall provide intensive treatment following a treatment plan developed by a multi-disciplinary staff team on the basis of an evaluation of the patient's needs. A variety of psychiatric modes shall be available, including psychopharmacological treatment, occupational therapy, activity therapy, and other necessary medical, psychological, and social services. (2) There shall be an acceptable plan and procedure which fix responsibility for the care and treatment of the patient if an emergency occurs during the patient's stay within the day treatment service. (3) The treatment center shall have an agreement with at least one licensed general or psychiatric hospital to provide inpatient services as needed. (4) The day treatment program shall assure continuity of care by developing appropriate mechanisms for referral to outpatient services if the patient does not have a private therapist and to necessary support and residential services, developing written agreements whenever feasible. When patients continue in treatment with a therapist who is not a member of the day treatment program team, the program shall have an agreement with the therapist which clearly delineates relative treatment responsibilities of the day treatment team and the other therapist. (5) A registered nurse shall be on the premises throughout the treatment day. (6) Within 4 working days of admission, every patient shall have an individual treatment plan, developed collaboratively by a multi-disciplinary team, which clearly defines expectations and means of accomplishing the goals of the plan. The treatment plan shall be signed by the psychiatrist responsible for its development. The names of the other members of the mental health treatment team involved in the development of the plan shall be listed adjacent to the signature of the psychiatrist. The treatment plan shall describe the patient's problems and probable diagnosis, state the short- and long-term goals of treatment, and delineate the modalities, including medications, to be used to accomplish these goals. The treatment plan shall record any physical condition which can affect the treatment plan. (7) There shall be a utilization review committee which shall include at least one qualified person who has no financial or other direct interest, past or present, in the treatment of the patient or the operation of the program. In addition to its other duties, the committee shall review the treatment plans for patients whose expected length of stay exceeds 30 full treatment days. (8) Programs for children, adolescents, and adults shall be separate, although some activities may be shared with mutual benefit. (9) Each day treatment program shall describe in writing its mechanisms for quality assurance, including systematic case review and program evaluation, and shall define the composition and responsibilities of the utilization review committee. C. Capacity of Psychiatric Day Treatment Center. The number of persons treated at any one time in each psychiatric day treatment center shall be limited according to the premises, staff, and equipment as set forth in Regulation .10 of this chapter. #### Regulation .03 Admission Policies. *COMAR 10.21.02.03* A. Criteria for admission shall be established for types of patients the program is designed to benefit, the goals and objectives of treatment, and the means by which these goals and objectives will be accomplished. B. Admission criteria may not discriminate against anyone on the basis of age, sex, race, creed, color, national origin, or handicapping conditions. For clinical purposes, program services may be offered for defined target groups. C. Admission criteria shall take into account the physical and medical status of the patient. Measures shall be taken to assure that patients are free from communicable diseases, such as tuberculosis. D. Programs shall require that the referring source submit written records whenever possible. E. Criteria for admission shall be available to the utilization review committee. #### Regulation .04 Discharge Policies. *COMAR 10.21.02.04* Criteria for discharge shall be established and shall be available for use by the utilization review committee. Discharge criteria may include, but not be limited to, symptomatic improvement; readiness for participation in voluntary, educational, or vocational programs; achievement of treatment goals; inability to comply with program requirements; or the need for 24-hour hospitalization. #### Regulation .05 Records. *COMAR 10.21.02.05* A. Clinical records shall contain sufficient information to identify the patient clearly, to support the diagnosis, to justify the treatment plan, and to document the results accurately. B. A clinical record shall be established for every person admitted to a day treatment program and shall include: (1) Identifying information, including names, current addresses, and telephone numbers of the patients, relatives, or guardians; (2) Presenting problem, the results of mental and physical examinations, diagnosis, treatment plan, a record of the implementation of the treatment plan, and the discharge disposition and referrals; (3) Evidence of appropriate release-of-information procedures and informed consent, if applicable. C. A system of identification and filing of clinical records shall be maintained to facilitate the prompt location of the patient's clinical record. D. Provision shall be made for storing records to assure their security and to maintain their confidentiality. E. The record shall be retained for at least 3 years after the discharge of a patient unless the patient is a minor. In that case, it shall be retained for at least 3 years past the date on which the minor would reach the age of majority. Record retention by State or State-funded programs shall conform to the requirements of the records management division. #### Regulation .06 Staff. *COMAR 10.21.02.06* A. Professional and paraprofessional staff shall be adequate to carry out the treatment program. B. Minimum requirements for the staff are as follows: (1) The staff of a psychiatric day treatment program shall be a multi-disciplinary team, including a psychiatrist, a registered nurse, and representatives of other appropriate disciplines, at least on a part-time basis. (2) The psychiatrist on the team shall be responsible for overall patient care. The mental health team, including a psychiatrist, shall evaluate and make a diagnosis for each patient and shall develop a treatment plan. After the treatment plan is made, a psychiatrist shall be involved in the treatment plan as needed and shall be available on call. He shall meet with the staff at least weekly to review treatment plans for each individual patient. (3) Each day treatment program shall have a director with clearly defined authority and responsibility for administration and service. (4) Each program shall establish a system of supervision and of continuing education and training for all staff, including any students. (5) If volunteers are employed in patient care, programs shall provide a system of screening and training volunteers. Volunteers shall receive continuing supervision in their activities. The supervisor shall assure that volunteers are not asked to perform duties beyond their skill and understanding. #### Regulation .07 Medications. *COMAR 10.21.02.07* Medications shall be stored separately in locked facilities and dispensed by qualified staff, in conformity with Health Occupations Article, §12-301, Annotated Code of Maryland. #### Regulation .08 Organizational and Administrative Structure. *COMAR 10.21.02.08* A. Any corporation delivering day treatment services shall have a valid charter of incorporation. B. Every day treatment program shall have a mechanism to assure community and consumer participation in the establishment of policies and procedures related to the operation of the program and for continuing review and evaluation of the implementation of these policies. Participation may be provided by inclusion of consumer and community representatives in the membership of the board of directors, if one exists, or by an advisory board whose members include consumer and community representatives. Existing boards of directors or advisory boards of sponsoring agencies may perform this function if consumer and community interests are appropriately represented. C. Standards for Administration of Day Treatment Programs. (1) There shall be an organizational chart clearly showing intra-organizational relationships and lines of authority. (2) Every program shall have a policies-and-procedures manual which, among other elements, describes its mission, its geographic service area, its target population, its organizational structure, its clinical policies, its operating procedures, types of services provided, with responsibility for supervision clearly defined. (3) There shall be a personnel policy manual which shall include written job descriptions for all staff positions, policies and procedures for personnel evaluation, and grievance procedures. (4) Every program shall have an itemized budget showing all sources of income and the services being funded. (5) All programs shall maintain a generally accepted accounting system. D. Patient Rights. (1) Written policies describing patient rights shall be made available to persons admitted to the service. (2) All patient information, verbal and written, shall be held confidential and restricted to staff members engaged in the treatment of the patient, to individuals authorized to participate in quality assurance and utilization review of records, and to designated representatives of authorized funding, licensing, and certifying agencies which must evaluate programs in order to carry out their responsibilities. With proper authorization from the patient, relevant information may be disclosed to staff members of agencies providing necessary social and other support services to the patient. (3) Program staff shall provide the patient in writing with a description of the program, including admissions and discharge policies, and an explanation of charges and methods of determining fees. (4) Program staff shall establish mechanisms to assure the patient of the opportunity to be consulted and informed on procedures related to his care. The leader of the patient's treatment team shall give him, on request, current information in regard to his treatment and condition. (5) Program staff shall inform patients receiving chemotherapy of the effects of the medication, including benefits and possible side effects. (6) Program staff shall establish mechanisms for patients to register grievances and for appeal and review. #### Regulation .09 Process of Approval and Appeal. *COMAR 10.21.02.09* A. The Mental Hygiene Administration shall be responsible for approving the programmatic aspects of the day treatment services. Approval shall be issued on the basis of a formal scheduled site visit by a designated evaluation team of the Administration on the basis of these regulations. B. Initial Approval. (1) The site-visit team shall make a recommendation for approval or disapproval in writing to the Director of the Mental Hygiene Administration. A copy of the recommendation shall be sent simultaneously to the program. (2) The program shall have the right to question the recommendation of the evaluation team by sending a reply in writing to the Director of the Mental Hygiene Administration within 20 days of the receipt of the recommendation. This reply shall give reasons why the recommendation is not justified. (3) Upon request, a conference shall be held with all parties present before the final determination. (4) The Director of the Mental Hygiene Administration shall have the final decision for granting or withholding approval to programs after consideration of the position presented by the evaluated program and after consultation with members of the site-visit team. C. Provisional Approval. Provisional approval may be granted to programs in which the deficiencies cited have no adverse effect on the life-safety or health status of patients and the facility has concrete plans to correct these deficiencies by a prescribed date. The Mental Hygiene Administration may establish conditions in giving provisional approval and set a date by which those conditions shall have been met. D. Revocation of Approval. (1) Approval may be revoked after notice and hearing before the Director of the Mental Hygiene Administration or his designee upon finding of failure to comply with standards or to comply with conditions of approval when a provisional approval has been given. (2) Notice of an intent to revoke approval and the grounds for the revocation shall be given in writing to the Director of the program. (3) The program shall have the right to file a reply in writing to the notice of intent to revoke within 20 days of the receipt of the notice. The reply shall set forth why the revocation is not justified. (4) The program shall have the right to representation by counsel, and the hearing shall follow procedures set forth in COMAR 10.01.03 Procedures for Hearings Before the Secretary of Health. (5) A program whose approval has been revoked may appeal the decision to the Secretary of Health under Article 41, §251, according to the procedures set forth in COMAR 10.01.03 Procedures for Hearings Before the Secretary of Health. #### Regulation .10 Physical Plant. *COMAR 10.21.02.10* A. Location. The premises on which a psychiatric day treatment center is to be located shall be served by a good road. Accessible public transportation is desirable. B. Communication. There shall be at least one telephone readily available — not a pay station or locked telephone — in the building and additional telephones or extensions as may be required to summon help promptly in case of fire or other emergencies. C. Buildings. (1) Any building used for a psychiatric day treatment center shall be kept in good repair, neat, clean, attractive, and safe. Housekeeping shall meet the highest possible standards of hygiene and cleanliness. All floors, walls, ceilings, windows, and fixtures shall be kept clean. Interior walls and floors shall be of a character to permit frequent and easy cleaning. The building shall be accessible to the handicapped. The facility shall be kept free of unnecessary accumulations of unused furniture, equipment, linen, clothing, and similar items. All paint shall be free from lead. (2) The director shall provide for the safety and protection of all occupants and assure the elimination of all hazards. Adequate provision and training shall be made for fire-control equipment, fire escapes, and evacuation of persons in case of fire or other emergency. Fire drills shall be held on a regular basis. (3) Any proposed alterations, additions, or changes shall be submitted to the health authority so that they may be approved or disapproved with such recommendations as deemed necessary. D. Sanitation. (1) Sewage Disposal. The method of sewage disposal shall conform to COMAR 10.17.03 and be approved by the health authority. (2) Water Supply. A safe drinking-water supply, as determined by COMAR 10.17.02 and approved by the health authority, shall be provided. (3) Plumbing. All plumbing and plumbing fixtures shall be so constructed, installed, and maintained as to prevent cross-connections or other sanitation hazards, as required by the applicable State and local plumbing codes. (4) Garbage and Refuse Disposal. Garbage and refuse shall be kept in watertight metal containers with tight-fitting covers and shall be removed from the premises at frequent intervals. E. Heating. (1) The building, whenever possible, shall be equipped with a heating plant with design capability of maintaining a temperature of 75°F in mean winter temperatures in patient areas. (2) Space heaters and portable heaters are prohibited. (3) Chimney, flues, and pipes connected with the heating facility shall be checked and cleaned annually. (4) The fuel supply shall be handled according to the regulations of the State Fire Prevention Commission. If coal is used, ashes may not be stored in flammable containers pending disposal. F. Insects and Rodents. The premises shall be maintained free of insects and rodents through an active pest-control program and elimination of garbage. G. Gas and Electric Appliances. All gas appliances shall be installed and used in accordance with the applicable codes. H. Screens. (1) All outside doors, windows, and other outside openings shall be screened with wire screen or its equal with not less than 16 meshes per linear inch. (2) All screen doors shall be equipped with self-closing devices and, when closed, fit tightly enough to prevent entrance of flies, mosquitoes, other insects, and rodents. (3) Window screens shall fit closely enough to keep out insects and be easily removed. I. Lighting. Each area used for therapy purposes shall be provided with sufficient artificial lighting so that the combined natural and artificial lighting shall be capable of providing a minimum illumination of 100-foot candles at work surfaces at all times when the psychiatric day treatment center. is in operation and at least 20-foot candles on all stairways and corridors. Glare shall be kept at a minimum by: (1) Providing shades or curtains at all windows exposed to direct sunlight unless seating is arranged so that no person while at work will be required to face a glaring surface; (2) Using lighting fixtures designed so that bare lamps or tubes are shielded at normal viewing angles; (3) Using light-colored flat paint or other light finishes on ceilings and upper side walls (semi-gloss finishes may be used on lower side walls and other wood trim where frequent cleaning is necessary); (4) Employing non-glossy, light-colored finishes on work tables to minimize glare by reflection. J. Space and Ventilation Requirements. (1) Adequate space to meet the requirements of program activities shall be available. Space for individual and group therapy, for occupational and activities therapy, and a kitchen area for patient use in acquiring and practicing activities of daily living shall be available. (2) Rooms with a total window area of less than 10 percent and an openable window area of less than 5 percent of the floor area may be used only if there is provision for air exchange and ventilation according to the standards of the ASHRAE Code. (3) Healthful humidity and comfortable temperatures shall be maintained in patient areas during the summer months. K. Sanitary Facilities. (1) The drinking-water supply may not be located in the bathroom. One drinking-water facility shall be available for every 4o persons or fewer on each floor. (2) There shall be one toilet and one lavatory provided for every 10 persons of the same sex or fewer. The lavatory shall be in close proximity to each toilet. The floor in each toilet room shall have a waterproof, non-absorbent finish, and the walls shall be smoothly finished with a hard surface. Grab bars shall be provided in toilets and bathing areas. (3) Towels shall be of the single-service type and shall be provided on single-service towel dispensers in all toilet rooms. Mechanical hand-drying devices may be used instead of towel dispensers. (4) There shall be hot and cold running water, soap, and toilet paper provided in the toilet rooms at all times. The temperatures of the hot water may not exceed 125°F in patient areas. L. Food Facilities. If food is prepared on the premises, the applicable sections of COMAR 10.15.03 relating to approved source of food, food temperatures and storage, storage of dangerous chemicals, handwashing, and dishwashing (sanitizing) shall serve as the standards. M. Safety. (1) Stairways shall be kept free of obstructions. Fire-exit doors shall be maintained in working order. The facility shall be free of mechanical and electrical hazards. Non-slip surfaces and coverings shall be provided in risk areas, such as tubs, showers, and stairways. (2) Poisonous and flammable products are prohibited unless stored in accordance with State Fire Prevention code requirements. N. Provisions for Handicapped. Provisions for the handicapped shall be made according to the American National Standards Institute (ANSI) A 117.1 to meet the anticipated needs of the population served. O. Janitors' Closets and Slop Sinks. (1) The facility shall provide janitors' closets with slop sinks as follows: (a) At least one per building shall be provided in non-hospital-based programs; (b) At least one for every 100 persons, one per resident building, or one per resident floor, whichever is most stringent, shall be provided in hospital-based programs. (2) Mops and supplies may not be stored on the floor in the closet. (3) The closet shall be vented to the outside. P. Storage. Storage areas shall be provided and located according to efficiency of scheduling, operation, and patient needs. Q. Minimal Equipment. Minimal equipment for a psychiatric day treatment center shall be adequate to meet the demands of the program according to the number of clients in attendance. ### Chapter 03 — Requirements for Individual Treatment Plans **Authority:** Health-General Article, §10-705, Annotated Code of Maryland **Administrative History:** Effective date: June 25, 1975 (2:14 Md. R. 1016) **Administrative History:** Annotation: COMAR 10.21.03 cited in Attorney General Opinion No. 82-034 (November 18, 1982) **Administrative History:** Chapter revised effective January 9, 1989 (15:27 Md. R. 3129) #### Regulation .01 Scope. *COMAR 10.21.03.01* A. These regulations shall apply to every individual admitted either voluntarily or involuntarily to any inpatient mental health facility licensed by, or under the jurisdiction of, the Maryland Department of Health. These regulations may not apply to institutions for the care of developmentally disabled patients, or to those patients committed by the courts for evaluation only. B. These regulations are supplemental to any other laws and regulations that may be applicable. In the event of conflict between these regulations or laws and any other regulations or laws, the more stringent shall apply. #### Regulation .02 Definitions. *COMAR 10.21.03.02* A. “Active treatment” means the regular participation by a patient in professionally developed and supervised activities, experiences, or therapies based on an individual treatment plan. B. “Department” means the Maryland Department of Health. C. “Mental health professional treatment team” means: (1) One or more duly licensed physicians or psychiatrists, one of whom shall assume responsibility for the development and implementation of an individual treatment plan. If the physician member of the mental health professional treatment team has less than 2 years of post-degree experience in a mental health setting, at least one other member of the team shall have attained the master's degree and have 2 years of post-degree experience in a mental health setting. (2) One or more of the following mental health professionals: (a) A psychologist, licensed in the State, or an individual with a master's degree in psychology or a related field from an accredited college or university in a program acceptable to the Board of Examiners of Psychologists, under the supervision of a licensed psychologist, and with at least 2 years of postdegree experience in a mental health setting; (b) A professional registered nurse licensed in the State with at least one of the following credentials: (i) Two years of psychiatric nursing experience; (ii) A bachelor of science degree and 1 year of psychiatric experience; or (iii) A master's degree and 1 year of psychiatric nursing experience; (c) A social worker, licensed in the State, with a master's degree in social work from an accredited school of social work and 2 years experience, 1 of which shall have been in a mental health setting; or (d) An occupational therapist, licensed in the State, with a bachelor of science degree in occupational therapy from an accredited school of occupational therapy and 2 years experience, 1 of which shall have been in a mental health setting. (3) Other members of the hospital staff who work directly with the patient, including other professionals and paraprofessionals and professionals in service and in training. D. “Patient” means any person voluntarily or involuntarily admitted to one of the mental health facilities under the jurisdiction of, or licensed by, the Maryland Department of Health pursuant to the provisions of Health-General Article, Title 10, Annotated Code of Maryland. #### Regulation .03 Content and Nature of Individual Treatment Plan. *COMAR 10.21.03.03* A. The individual treatment plan is a comprehensive and thoughtfully written plan based on an initial diagnostic impression and an overall evaluation of the patient's specific needs and problems. It includes an inventory of the patient's strengths as well as weaknesses, and sets forth short-term measurable goals and behaviorally stated objectives aimed at maximal restoration of the patient's adaptive capacity and return to the community as soon as possible. Based on the above goals objectives, a plan of active treatment shall be prescribed which aims at the arrest, reversal, and amelioration of the patient's illness symptoms. There shall be included a long-range discharge goal as well as an estimate of the probable length of inpatient stay needed before transfer to a less restrictive or intensive treatment milieu. B. The individual treatment plan shall be initially recorded and appropriately updated in the patient's permanent medical record. C. The initial individual treatment plan shall be developed by members of the mental health professional treatment team who are directly involved in the patient's care including at least one member each from Regulation .02C(1) and (2), of this chapter. The initial individual treatment plan shall be signed by the physician responsible for its development. The names of the other members of the mental health professional treatment team involved in the development of the plan shall be noted adjacent to the signature of the physician. D. A comprehensive, thoughtfully written, and properly signed individual treatment plan shall be recorded in the permanent medical record, or on a separate form which will become part of the permanent medical record, no later than 15 days after admission. E. The individual treatment plan shall include or refer to essential written or verbal information which has been gathered, as well as relevant information derived from other parts of the medical record, that will help identify the specific needs and problems of the individual patient. The individual treatment plan shall also include an initial psychiatric diagnosis recorded in the official nomenclature of the American Psychiatric Association, discharge planning data relating to community and financial resources available to the patient, and the legal status of the patient. Information may not be gathered without the consent of the patient or of the patient's parent or legally appointed representative if the patient is a minor or is incompetent. F. The individual treatment plan shall include a notation of any therapeutic task, labor, recreation, or other scheduled activity to be performed by the patient, including the rationale for these in relation to the treatment plan and the projected goals. G. The individual treatment plan shall include, when applicable, a description of the patient's individualized educational plan. Special education plans, in conformance with the regulations of the Department of Education, are mandatory for patients through 20 years old. H. The individual treatment plan shall include, when feasible, patient participation in accordance with Health-General Article, §10-706, Annotated Code of Maryland. I. Care shall be taken to preserve the confidentiality of the patient-mental health professional treatment team member relationship. Information from a patient's record, including the individual treatment plan, may not be disclosed to any person, organization, or agency except in the case of a court order or with the written consent of the patient or of the patient's parent, if the patient is a minor, or legally appointed representative, if the patient is incompetent. J. The individual treatment plan shall be periodically reassessed by members of the mental health professional treatment team who are working directly with the patient, including at least one member each from Regulation .02C(1) and (2), of this chapter, including the physician responsible for the implementation of the plan. This reassessment shall be made no less than once every 15 days for the first 2 months for all newly admitted or readmitted patients, and after that, at least once every 60 days. K. The mental health professional treatment team members who make the reassessment shall place a written entry in the permanent medical record or on a separate form which will become part of the permanent medical record. This entry shall be signed by the physician responsible for the implementation of the plan. The names of the other members of the mental health professional treatment team involved in the reassessment of the plan shall be noted adjacent to the signature of the physician. L. The initial individual treatment plan and all subsequent reassessments shall be easily identifiable as a separate, comprehensively written, and properly signed entry into the permanent medical record or on a separate form which will become part of the permanent medical record. #### Regulation .04 Severability. *COMAR 10.21.03.04* If any section or provision of these regulations is declared unconstitutional or void by any court of competent jurisdiction, or its applicability to any person or circumstances is held invalid, the constitutionality or validity of the remainder of these regulations and their applicability to other persons and circumstances may not be affected, and, to this end, the sections and provisions of these regulations are declared to be severable. ### Chapter 04 — Community Mental Health Programs — Group Homes for Adults with Mental Illness **Authority:** Health-General Article, §§10-514 — 10-524 and 10-604, Annotated Code of Maryland **Administrative History:** Effective date: July 25, 1980 (7:15 Md. R. 1424) **Administrative History:** Recodified from COMAR 10.21.05 to 10.21.04 **Administrative History:** Chapter revised effective October 14, 1991 (18:20 Md. R. 2199) **Administrative History:** Chapter, Group Homes for the Mentally Disabled, repealed and new Chapter, Community Mental Health Programs — Group Homes for Adults with Mental Illness, adopted effective October 5, 1998 (25:20 Md. R. 1529) #### Regulation .01 Scope. *COMAR 10.21.04.01* This chapter establishes the licensing procedure for group homes for adults with mental disorders. #### Regulation .02 Definitions. *COMAR 10.21.04.02* A. In this chapter, terms have the meanings stated in COMAR 10.21.17. B. Definition of Group Home. (1) “Group home” means a community-based residential program that provides services: (a) For individuals who have been or are under treatment for a mental disorder; (b) When possible, in the individual's community of origin; and (c) In a home-like environment. (2) “Group home” means a private group home as defined in Health-General Article, §§10-514(b), (d) — (e) and 10-518(b), Annotated Code of Maryland, as either a: (a) Small private group home, which: (i) Admits at least four but not more than eight individuals; and (ii) Is deemed conclusively a single-family residence and is permitted in all residential zones; or (b) Large private group home, which: (i) Admits at least nine but not more than 16 individuals; and (ii) Is deemed conclusively a multifamily residence and is permitted in zones of similar density. (3) “Group home” does not include a: (a) Foster home that is the domicile of the foster parent; or (b) Facility that is: (i) Owned by or leased to the State or any public agency; (ii) Regulated by the Department of Juvenile Services or Developmental Disabilities Administration; or (iii) Organized wholly or partly to make a profit. #### Regulation .03 Admission Standards. *COMAR 10.21.04.03* A. A group home may admit an individual if the individual: (1) Has a mental disorder; (2) Because of the mental disorder, requires residential services for assistance and support in community living; (3) Has the ability to understand and states, in writing, willingness to comply with the rules and regulations of the group home; and (4) Is able to take appropriate action, under emergency conditions, for self-preservation. B. A group home may not admit an individual if the individual: (1) Has a primary diagnosis of alcoholism, drug addition, or severe brain damage; or (2) Shows current violent or antisocial behavior. C. If an individual is a Medicaid recipient or an individual for whom, because of the severity of the illness and financial need, the cost of care is subsidized through the public mental health system, the individual may be admitted to a group home only if the services are preauthorized by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.09.70.07. #### Regulation .04 License Required. *COMAR 10.21.04.04* A. A person shall obtain a license from the Department before operating a group home. B. The Secretary shall grant a license to an applicant to operate a group home, as described in Regulation .02 of this chapter, if the applicant fulfills the requirements for: (1) Licensure under this chapter; (2) Administrative requirements under COMAR 10.21.17; (3) Psychiatric rehabilitation programs under COMAR 10.21.21; and (4) Residential rehabilitation programs under COMAR 10.21.22. #### Regulation .05 Application Process. *COMAR 10.21.04.05* A. Consultation. Before submitting an application, an applicant for licensure to operate a group home may request assistance from the Department's designated licensure unit or the appropriate core service agency (CSA) regarding the proper compilation of application materials and completion of the application. B. Application for Licensure. An applicant for licensure for a group home shall: (1) Submit, to the Department's designated licensure unit, a signed, notarized application on the form approved by the Department with the requirement that all questions be answered and all required documents be attached; (2) Include in the application: (a) The applicant's: (i) Name; (ii) Agency affiliation, if any; and (iii) Address; (b) Documentation: (i) Of the applicant's not-for-profit status; (ii) That the applicant has sufficient financial resources or that sufficient resources are available to the applicant for the establishment and operation of the residence; (c) The following information about the property: (i) The street address of the property or, if it has no street address, a description that adequately identifies the location; and (ii) If the applicant does not own the property, the name and address of the owner; (d) The satisfactory reports, not more than 1 year old, of the group home that are required by the local jurisdiction, including, at a minimum: (i) A fire safety inspection report; and (ii) In addition, for a large group home, a health inspection report; (e) Written material that describes how the applicant intends the program to comply with the: (i) Requirements outlined in this chapter; (ii) Administrative requirements outlined in COMAR 10.21.17; and (iii) Programmatic and staffing requirements outlined in COMAR 10.21.21 and 10.21.22; (f) When applicable, a letter of intent that explains how the proposed services meet a need identified in the Administration-approved CSA plan; and (g) When applicable, documentation that the program will collaborate with the CSA, as required under COMAR 10.21.17.04; (h) Documentation that the group home: (i) Is compatible with the nature and character of the area involved; (ii) Is near transportation facilities; and (iii) Meets or, on completion, will meet general zoning requirements regarding size, density, land use, and architectural guidelines that apply to the location; (3) Submit with the application a copy of the residential specialist's certificate of approval of the residence, as granted under the provisions of COMAR 10.21.22; and (4) Forward a copy of the: (a) Application cover letter to the Administration; and (b) Application to the: (i) CSA, if the jurisdiction in which the program is to be located is served by a CSA; or (ii) Health officer, if the jurisdiction in which the program is to be located is not served by a CSA. #### Regulation .06 Licensure. *COMAR 10.21.04.06* A. Initial License. (1) Within 90 days of receipt of an application completed according to Regulation .05B of this chapter, the Department's designated licensure unit: (a) Shall: (i) Evaluate the application; (ii) Meet with the applicant; and (iii) Conduct an on-site review to inspect the physical plant and evaluate the proposed group home; and (b) May ask the group home program director to submit a program improvement plan regarding deficiencies cited by the licensure unit. (2) Based on the evaluation conducted under §A(1)(a) and the results of the plan under §A(1)(b) of this regulation, the Secretary shall either: (a) Issue a license for a period of 2 years, if the group home: (i) Has no deficiencies that constitute a threat to the health, safety, or welfare of the individuals served; and (ii) Complies with the requirements outlined in this chapter and COMAR 10.21.17, 10.21.21, and 10.21.22; or (b) Propose to deny a license. (3) If the Secretary takes the action in §A(2)(b) of this regulation, the Secretary shall advise the applicant of hearing rights, as described in Regulation .12 of this chapter. B. Renewal License. (1) If a group home licensee proposes to continue to operate, the licensee shall file an application for renewal: (a) At least 60 days before the expiration of the current license; (b) With the Department's designated licensure unit, with copies to the CSA and the Administration; and (c) On the form approved by the Department with the requirement that all questions be answered and all required documents be attached. (2) Upon receipt of an application for renewal, the Department's designated licensure unit: (a) Shall conduct an on-site evaluation of the group home; and (b) May ask the group home program director to submit a program improvement plan regarding deficiencies cited by the licensure unit. (3) Based on the evaluation under §B(2)(a) and the results of the plan under §B(2)(b) of this regulation, the Secretary shall either: (a) Issue a license for a period of 2 years, if the group home: (i) Has operated satisfactorily under the current license; and (ii) Complies with the requirements outlined in this chapter and COMAR 10.21.17, 10.21.21, and 10.21.22; or (b) Propose to deny a license. (4) If the Secretary takes the action in §B(3)(b) of this regulation, the Secretary shall advise the applicant of hearing rights, as described in Regulation .12 of this chapter. C. Waivers and Variances. (1) Waivers. The Secretary may not waive the requirements of any regulation adopted under this chapter. (2) Variances. (a) The Secretary may grant a variance to a regulation if the Secretary: (i) Receives a written request from a program; and (ii) Finds that the intent of the regulation to which a variance is sought is met by the alternative proposed by the program. (b) The Secretary may not grant a variance that would endanger the health or safety of the individuals served. (c) The Secretary may grant a variance that: (i) Remains in effect for as long as the program continues to comply with the conditions under which the variance is granted; or (ii) Is time limited. (d) The Secretary shall issue a written decision, including the reason or reasons for granting or not granting the variance, and shall: (i) Send the decision to the program for inclusion in the program's official file; and (ii) Enter the decision in the records of the Department. #### Regulation .07 Deemed Status. *COMAR 10.21.04.07* A. Request for Deemed Status. If a group home is licensed by the Department and is accredited by the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) or the Rehabilitation Accreditation Commission (CARF), the governing body of the group home may request that the Secretary grant the group home deemed status by submitting a written request: (1) At least 90 days before the expiration of the group home's license; (2) To the: (a) Administration; (b) CSA, if the jurisdiction in which the program is to be located is served by a CSA; and (c) Health officer, if the jurisdiction in which the program is to be located is not served by a CSA; and (3) That includes the: (a) Application required under Regulation .05B of this chapter; and (b) Accreditation body's full report including the group home's status and any conditions placed on the group home. B. Evaluation of Request for Deemed Status. Within 30 calendar days of receipt of the request under §A of this regulation: (1) The Administration, in consultation with the CSA: (a) Shall evaluate the: (i) Application; (ii) Report of the accreditation body; and (iii) Most recent report by the Department's designated licensure unit; (b) May meet with the applicant; and (c) May arrange for an on-site evaluation; and (2) The Director shall recommend to the Secretary a decision regarding deemed status, based on: (a) Comparison of the standards used by the accreditation body with the requirements outlined in COMAR 10.21.17, 10.21.21, 10.21.22, and this chapter; and (b) The results of an on-site evaluation, if any. C. Decision Regarding Deemed Status. Based on the evaluation of the request for deemed status conducted under §B of this regulation, within 45 calendar days of completion of the evaluation, the Secretary shall: (1) Decide, whether to: (a) Grant deemed status; (b) Grant deemed status with conditions, which may include evaluation by the Department's designated licensure unit; or (c) Propose to deny deemed status; and (2) Send notice of the proposed decision to the: (a) Department's designated licensure unit; (b) Governing body; (c) Group home director; (d) Administration; and (e) As applicable, either the CSA director or health officer. D. Proposal to Deny Deemed Status. (1) If the Secretary proposes to deny approval of deemed status, the Secretary shall give written notice of the proposed denial to those listed in §C(2) of this regulation. (2) In the notice under §D(1) of this regulation, the Secretary shall include: (a) The date that the Secretary proposes to deny approval of deemed status; (b) Location, including street address, to which the proposed denial applies; (c) The facts that warrant the proposed denial; and (d) Notification that, before the denial, the program has a right to a hearing. (3) Upon receipt of the notice under §D(2) of this regulation, the chairman of the governing body may: (a) Withdraw the request for deemed status; and (b) Request an on-site review for approval by the Department's designated licensure unit. (4) If the governing body does not take the action under §D(3) of this regulation and if, after notice and opportunity to be heard, the Secretary denies approval of deemed status, the Director shall notify the governing body that, unless the program elects not to seek approval, the Department's designated approval unit shall conduct an on-site review for the purpose of granting or denying a license. #### Regulation .08 Program Inspection and Investigation by the Department. *COMAR 10.21.04.08* A. The Department may make announced and unannounced visits to a group home. B. If the Department receives information that the safety or welfare of an individual served is in jeopardy, the Department shall promptly: (1) Conduct and document an investigation; and (2) Based on the investigation under §B(1) of this regulation, take appropriate action, including: (a) Outlining the requirements for the group home to correct the problems identified; or (b) Initiating any of the following: (i) Emergency suspension, under the provisions of Regulation .09B of this chapter; (ii) Disciplinary action, including suspension, revocation, probation, or banning new admissions under the provisions of Regulation .09C of this chapter; or (iii) Receivership, under the provisions of Regulation .11 of this chapter. #### Regulation .09 Denial and Emergency Suspension of Licensure and Disciplinary Action. *COMAR 10.21.04.09* A. Denial of License. (1) If the Secretary proposes to deny a license to an applicant under the provisions of this chapter, the Secretary shall give written notice of the proposed denial to the: (a) Chairman of the governing body; (b) Program director; (c) Administration; and (d) As applicable, either the CSA director or the health officer. (2) In the notice under §A(1) of this regulation, the Secretary shall include: (a) The date on which the Secretary proposes to deny the license; (b) Location, including street address, to which the proposed denial applies; (c) The facts that warrant the proposed denial of the license; (d) Citation of the regulation or regulations upon which the proposed denial is based; and (e) Notification that, before the deprivation of a license, the group home may request a hearing under the provisions of Regulation .12 of this chapter. (3) If, after notice and opportunity to be heard, the Secretary denies a license to a group home, the governing body shall assure that, within 10 working days, the program director: (a) Notifies the residents in the group home of the denial; (b) When appropriate, notifies the CSA or the Administration of the denial and cooperates with the CSA or the Administration in accessing appropriate alternate housing for individuals in the group home; and (c) Ceases operations of the group home. B. Emergency Suspension of License. (1) Pursuant to State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a group home, the Secretary may order the immediate suspension of the license of the group home and the cessation of operations. (2) If the Secretary takes the action under §B(1) of this regulation, the Secretary shall promptly give written notice of the proposed emergency suspension to the: (a) Chairman of the governing body; (b) Program director; (c) Administration; and (d) As applicable, either the CSA director or the health officer. (3) In the notice under §B(2) of this regulation, the Secretary shall include: (a) The effective date of the emergency suspension; (b) Location, including street address, to which the emergency suspension applies; (c) The findings under §B(1) of this regulation and the reasons that support the findings; (d) Notification that: (i) Following the emergency suspension, the group home may request a hearing under the provisions of Regulation .12 of this chapter; and (ii) The emergency suspension may lead to revocation of the license if the violation or violations are not corrected within the time period specified by the Department. (4) If the Secretary suspends the license, the governing body shall assure that the program director immediately takes the action described under §A(3) of this regulation. C. Disciplinary Action. (1) The Secretary may propose to take any of the following disciplinary actions against the license to operate a group home: (a) Revocation; (b) Suspension; (c) Probation, with conditions; or (d) Banning new admissions. (2) The Secretary may propose to take one of the actions outlined in §C(1) of this regulation if the group home: (a) Is out of compliance with the requirements of this chapter; or (b) Obtains or attempts to obtain licensure by fraud, misrepresentation, or the submission of false information to the Secretary. (3) Within 45 calendar days in advance of the proposed action taken under this regulation, the Secretary shall send written notice of the proposed action to the: (a) Chairman of the governing body; (b) Program director; (c) Administration; and (d) As applicable, either the CSA director or the health officer. (4) In the notice under §C(3) of this regulation, the Secretary shall include: (a) The date on which the Secretary proposes to take action against the license; (b) Location, including street address, to which the proposed action applies; (c) The facts that warrant the proposed action; (d) Citation of the regulation or regulations upon which the proposed action is based; and (e) Notification that, before the action, the group home has the right to request a hearing under the provisions of Regulation .12 of this chapter. (5) If, after notice and opportunity to be heard, the Secretary takes disciplinary action, the governing body shall assure that, within 10 working days, the program director takes the action described under §A(3) of this regulation. #### Regulation .10 Group Home Request. *COMAR 10.21.04.10* If a group home requests that licensure be discontinued: A. The Secretary shall discontinue licensure; and B. The governing body shall assure that, within 10 working days, the program director takes the action described under Regulation .09A(3) of this chapter. #### Regulation .11 Initiation of Receivership. *COMAR 10.21.04.11* The Secretary may take action to initiate receivership under the provisions of Health-General Article, §§19-333 — 19-339, Annotated Code of Maryland. #### Regulation .12 Procedures for Hearings. *COMAR 10.21.04.12* A. Within 10 working days of receipt of notification that the Secretary proposes to deny approval or initiate disciplinary action, the chairman of the governing body may file a written request for a hearing with the Office of Administrative Hearings, with copies to the: (1) Administration; (2) CSA director; and (3) Director of the Department's designated licensure unit. B. If the chairman of the governing body does not file a request for hearing that is post-marked within 10 working days of receipt of the notification, the group home waives the right to request a hearing, and the Secretary may effect the proposed action. C. If a timely request for hearing has been received, the Office of Administrative Hearings shall: (1) Notify the director and the chairman of the governing body of the date, time, and location of the hearing; and (2) Hold a hearing and render a proposed decision to the Secretary in accordance with COMAR 28.02.01. D. After giving parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Secretary shall issue a final decision according to State Government Article, §10-221, Annotated Code of Maryland, and send notice of the decision to the: (1) Director; and (2) Chairman of the governing body. E. Further Appeal. A group home may appeal any final decision by the Secretary by following the provisions of Health-General Article, §10-524, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. ### Chapter 05 — Aftercare Plans **Authority:** Health-General Article, §§10-709 and 10-809, Annotated Code of Maryland **Administrative History:** Effective date: December 14, 1998 (25:25 Md. R. 1831) #### Regulation .01 Scope. *COMAR 10.21.05.01* This chapter applies to aftercare plans, which are: A. Provided to an individual who has been accepted under the provisions of Health-General Article, Title 10, Subtitle 6, Health-General Article, Title 12, Subtitle 1, or Courts and Judicial Proceedings Article, Title 3, Subtitle 8, Annotated Code of Maryland, in one of the following: (1) Mental Hygiene Administration facility under Health-General Article, §10-406, Annotated Code of Maryland; (2) Private psychiatric inpatient facility; (3) Residential treatment center for children and adolescents; or (4) Psychiatric unit in an acute care general hospital; and B. Designed to: (1) Enhance the opportunity for the individual to live in the community; and (2) Assist in the prevention of homelessness. #### Regulation .02 Definitions. *COMAR 10.21.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accepted” means: (a) Taken into confinement on the basis of an application and certificate for involuntary admission, according to the provisions of Health-General Article, §§10-614 — 10-616, Annotated Code of Maryland; or (b) Admitted, as defined in §B(4) of this regulation. (2) “Administration” means the Mental Hygiene Administration. (3) “Administrative services organization (ASO)” means the organization under contract with the Administration to provide administrative services for the public mental health system. (4) “Admitted” means: (a) Admitted voluntarily, according to the provisions of Health-General Article, §10-609 or 10-610, Annotated Code of Maryland; (b) Admitted involuntarily, by an administrative law judge, according to the provisions of Health-General Article, §10-632, Annotated Code of Maryland; or (c) Committed by a court according to the provisions of: (i) Health-General Article, Title 12, Subtitle 1, Annotated Code of Maryland; or (ii) Courts and Judicial Proceedings Article, Title 3, Subtitle 8, Annotated Code of Maryland. (5) “Aftercare plan” means the plan developed by inpatient facility staff according to the requirements of Health-General Article, §10-809, Annotated Code of Maryland. (6) “Chief executive officer (CEO)” means the individual responsible for the overall management of a facility. (7) “Discharge” means authorization by a physician for a voluntarily or involuntarily admitted individual to leave an inpatient facility. (8) “Proper consent” means consent given by the individual, or, if the individual is a child or adolescent, by the individual's parent or guardian, to release relevant information. (9) “Release” means the authorization for an individual who is confined in an inpatient facility on the basis of an application and certificate for involuntary admission to leave the inpatient facility: (a) Given by a physician during the observation status period; or (b) Ordered by an administrative law judge at an involuntary admissions hearing. #### Regulation .03 Content and Nature of Aftercare Plans. *COMAR 10.21.05.03* A. Staff designated by the CEO to assist individuals in aftercare planning shall, as soon as possible after acceptance, in collaboration with the individual: (1) Initiate the aftercare planning process; (2) With proper consent, involve in the aftercare planning process: (a) Community-based service providers; (b) Family members; (c) Others who have a personal interest in the individual; and (d) Third-party payors, including Medical Assistance, the Administration's ASO, or private insurance carriers, if involved, for authorization of outpatient services; (3) Assist in applying for benefits to which the individual may be entitled and document the outcome of the benefits application process in the individual's record. B. Before discharge or release, designated staff shall: (1) Provide notification of the discharge or release: (a) With proper consent, to: (i) The individual's next-of-kin; (ii) As appropriate, the core service agency (CSA); (iii) Community-based treatment and support services providers rendering services before the individual's inpatient admission; and (iv) Third-party payors, including Medical Assistance, the Administration's ASO, or private insurance carriers, if involved, for authorization of outpatient services; and (b) If the individual is a minor, to the parent or guardian; and (2) Assist the individual to participate in the aftercare plan by: (a) Explaining to the individual the benefits of: (i) The aftercare plan; (ii) Community-based treatment and support services; and (iii) The involvement of family or others who have a personal interest in the individual; (b) Encouraging the individual to consent to the aftercare plan; and (c) Arranging appointments for the individual with appropriate community programs. C. In collaboration with community programs and government agencies that have agreed to provide aftercare services to the individual after discharge or release, designated staff shall prepare a written aftercare plan that includes: (1) The individual's: (a) Name; (b) Date of birth; and (c) Address and telephone number upon discharge or release; (2) For a minor or an individual under guardianship, the name, address, and telephone number of the custodial adult or guardian; (3) If the individual will reside in program-arranged housing, the name, address, telephone number, and contact person of the placement agency; (4) The date and type of admission and discharge or release; (5) The scheduled court date, if any; (6) The diagnoses, including existing psychiatric, somatic, and dental diagnoses, and level of functional assessment; (7) The type of treatment initiated; (8) The name, address, and telephone number of the primary care provider; (9) Medication information, including the: (a) Medication prescribed; (b) Dosage schedules; (c) Amount of each medication given to the individual upon discharge or release; and (d) Information necessary to help the individual to obtain the prescribed medication in the community; (10) The most recent laboratory results, including therapeutic drug levels; (11) If applicable, a description of: (a) Allergies, including medication allergies; (b) Nutritional requirements; and (c) Active somatic problems requiring continued attention; (12) Information on the individual's medical insurance coverage, including the: (a) Company; (b) Policy number; (c) Name of the policy holder; and (d) Preauthorization information, if given, for services to be initiated upon discharge or release; (13) Entitlements, if any, and status; (14) The plan for continuing treatment, including but not limited to: (a) Outpatient mental health treatment services; (b) Somatic care; (c) Psychiatric rehabilitation and support services; (d) When appropriate, substance abuse services; and (e) Case management; (15) A list of additional referrals indicated, such as: (a) Public social services; (b) Legal aid; (c) Educational services; (d) Housing services; (e) Vocational services; (f) Peer support services; and (g) Available crisis services; and (16) Any identifying information required by the Administration's ASO. #### Regulation .04 Distribution of Aftercare Plan. *COMAR 10.21.05.04* A. Designated staff shall provide the individual with the opportunity to consent or withhold consent for release of all or any portion of the plan to any provider. B. Within 48 hours or by the first appointment, whichever is sooner, designated staff shall provide the aftercare plan, in accordance with the provisions of §A of this regulation, to the: (1) Community treatment and support programs designated in the aftercare plan; (2) Family members or others with a personal interest in the individual, if any, who are identified in the aftercare plan to provide housing; and (3) Third-party payors, if involved, for authorization of outpatient services. C. Designated staff shall document in the individual's medical record who received information from the aftercare plan. D. If the individual does not consent to an aftercare plan, designated staff shall: (1) Place in the individual's record a statement to this effect signed, when possible, by the individual, the individual's guardian, or, for a minor, the parent or guardian; and (2) Provide to the individual, in writing, information on outpatient mental health clinics, crisis and emergency services, and other available community mental health services and resources within the jurisdiction in which the individual resides, and document in the individual's record what information was provided. ### Chapter 06 — Admission to Regional Institutes for Children and Adolescents **Authority:** Health-General Article, §§2-104, 10-204, 10-401, 10-406, 10-407, 10-602, 10-609, and 10-610, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1985 (12:9 Md. R. 811) #### Regulation .01 Scope. *COMAR 10.21.06.01* This chapter establishes procedures and standards for residential admission to the Regional Institutes for Children and Adolescents (RICAs). The RICAs are mental health facilities licensed and operated by the Maryland Department of Health for the residential treatment of severely emotionally disturbed children and adolescents. #### Regulation .02 Definitions. *COMAR 10.21.06.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Maryland Department of Health. (2) “Applicant” means a child or adolescent who is the subject of an application for admission to a RICA. (3) “Director” means the Director of the Maryland Department of Health. (4) “Mental disorder” means a behavioral or emotional illness that results from a psychiatric or neurological disorder and is referenced in Health-General Article, §10-620(e)(1), Annotated Code of Maryland. (5) “Resident” means a child or adolescent who is admitted to a RICA for residential treatment. (6) “Residential treatment” means a program of active psychiatric treatment that is provided on a residential basis, under the direction of a psychiatrist, and in conformity with an individualized treatment plan. (7) “RICA” means a Regional Institute for Children and Adolescents. #### Regulation .03 Application for Admission. *COMAR 10.21.06.03* A. On referral by a public or private agency or mental health professional, application for admission to a RICA may be made by: (1) The parent or guardian of a child or adolescent under 18 years old; (2) An adolescent, if the adolescent is 16 years old or older; or (3) A State or county agency that has custody of a child or adolescent, with the signed consent of the parent or guardian or in accordance with a court order. B. The admission application shall be on a form prescribed by the Administration and shall include: (1) The name, date of birth, sex, legal domicile, and present residence of the applicant; (2) A statement based on clinical evaluation by a mental health professional that the applicant has a long term and severe mental disorder and is in need of residential treatment; and (3) A recent history of the applicant's psychiatric or psychological treatment, educational or special educational services, and involvement with community agencies. C. Available medical records and psychiatric or psychological evaluations describing the applicant's mental disorder and need for residential treatment shall be attached to the admission application. D. The referring agency or mental health professional shall be responsible for assuring that appropriate written consent is obtained so as to permit that all required completed application materials may be sent to the RICA. #### Regulation .04 Admission Procedures. *COMAR 10.21.06.04* A. Each RICA shall maintain an admission team which consists of a physician, mental health and educational professionals and other persons, as appropriate. The RICA admission team shall determine whether the applicant meets the admission standards set forth in Regulation .05 of this chapter, within 10 working days of receipt of the completed application. B. The applicant and referring agency or mental health professional shall be notified by the RICA admission team as to whether the applicant meets the admission criteria. C. If the admission team determines that the admission criteria are met, a pre-admission interview shall be scheduled by the RICA at the earliest convenient date for all parties involved. #### Regulation .05 Admission Criteria. *COMAR 10.21.06.05* A. A child or adolescent may be admitted to a RICA if the: (1) Individual has a long-term and severe mental disorder; (2) Individual has treatment needs that cannot be met through available community-based programs; (3) Residential treatment provided by the RICA can reasonably be expected to improve the individual's condition or prevent further regression so that the individual can return to the community. B. The child or adolescent shall be between 12 and 17 years old at the time of admission. The RICA admission team may waive the age limit in appropriate cases. C. A RICA may not admit a child or adolescent who has: (1) A primary diagnosis of alcoholism, drug addiction, or severe brain damage; or (2) Cognitive deficits which severely limit the individual's ability to use the treatment modalities provided. D. A child or adolescent who otherwise meets the admission standards may not be denied residential treatment solely because the individual resides outside the regular catchment area served by the RICA, as established by the Director. The Director shall take into consideration the ratio of residential treatment beds to population base and proximity to the program when establishing the catchment areas, and shall review and revise the catchment areas, as appropriate, every 5 years beginning in 1990. Priority for admission shall be given to applicants living in the catchment area served by the RICA. E. If a child or adolescent meets the admission standards but the RICA is occupied to its licensed capacity, priority on the waiting list for admission shall be given to those individuals who have the most severe mental disorders as exhibited by level of dysfunctions. #### Regulation .06 Resident Rights. *COMAR 10.21.06.06* A. Residents shall be accorded the rights enumerated in the Health-General Article, §§10-701 through 10-709, Annotated Code of Maryland, and shall be informed of these rights upon admission. B. An individualized treatment plan shall be developed and implemented for each resident in accordance with Health-General Article, §10-706, Annotated Code of Maryland, and COMAR 10.21.03. C. An educational program shall be provided for each resident based on educational needs and shall include, when appropriate, an individualized educational program in accordance with COMAR 13A.05.01. D. An aftercare plan shall be developed for each resident before release from a RICA in cooperation with the referring agency or professional, parent, or guardian or other appropriate agencies in accordance with the Health-General Article, §§10-709 and 10-809, Annotated Code of Maryland. #### Regulation .07 Court Evaluation Unit. *COMAR 10.21.06.07* A. A RICA may establish a separate unit for short term evaluation of children and adolescents referred by a Juvenile Court. B. Admission from the court evaluation unit to the regular residential treatment program shall be in accordance with the procedures and standards set forth in Regulations .04 and .05 of this chapter. ### Chapter 07 — Therapeutic Group Homes **Authority:** Health-General Article, §§10-501 — 10-524, 10-701 — 10-714, 10-901, 10-920 — 10-926, 16-101 — 16-303; Article 49D, §4; Annotated Code of Maryland **Administrative History:** Effective date: January 13, 1986 (13:1 Md. R. 16) **Administrative History:** Regulation .01 amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .02B amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .03 amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .05 amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .09A amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .14 amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulations .01 — .14 repealed and new Regulations .01 — .17 adopted effective November 27, 2000 (27:23 Md. R. 2147) **Administrative History:** Regulation .02 amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .03 amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .04 amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .05B amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .06 amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .07A amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .09 amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .11E amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .12F amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .13 amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .14B, C amended effective April 29, 2013 (40:8 Md. R. 723) **Administrative History:** Regulation .14G adopted effective April 29, 2013 (40:8 Md. R. 723) #### Regulation .01 Scope. *COMAR 10.21.07.01* This chapter establishes the procedures and standards for operating, programming, and staffing a therapeutic group home (TGH) for children. #### Regulation .02 Definitions. *COMAR 10.21.07.02* A. In this chapter, terms have the meanings stated in COMAR 14.31.05, 14.31.06, and in this chapter. B. Terms Defined. (1) “Administration” means the Mental Hygiene Administration. (2) “Case coordinator” means the mental health professional or residential care specialist supervised by a mental health professional who coordinates the services, as outlined in a child's TGH individual treatment plan (ITP), to the child. (3) “Clinical coordinator” means the mental health professional who is responsible for oversight of the clinical services provided to children in a TGH. (4) “Contact note” means an entry that: (a) Is made in an individual's medical record by a program staff member; and (b) Describes face-to-face, written, or telephone contact with or regarding the individual. (5) “Core service agency (CSA)” means the county or multi-county authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, and approved by the Department, that is responsible for planning, managing, and monitoring publicly funded mental health services. (6) “Department” means the Maryland Department of Health. (7) “Governor’s Office for Children (GOC)” means the office created under Executive Order 01.01.2005.34. (8) “Group home” means a private group home, as defined in Health-General Article, §10-514, Annotated Code of Maryland, that provides mental health services in a residential facility. (9) “Managed care organization (MCO)” means a health care organization, as defined in Health-General Article, §15-101(f), Annotated Code of Maryland. (10) “Medical record” means a record as defined in Health-General Article, §4-301, Annotated Code of Maryland. (11) “Mental health professional” means: (a) A psychiatrist; or (b) An individual who is authorized by the Health Occupations Article, Annotated Code of Maryland, to provide the service for which the individual is privileged. (12) “Primary caretaker” means the: (a) Child's custodial parent or parents; (b) Adult with whom the child currently resides; or (c) Legal guardian. (13) “Privileging” means the process by which a program determines that staff members are qualified to perform assigned duties. (14) “Progress summary note” means an entry by an individual's treatment coordinator in the individual's medical record and that describes the individual's progress toward the goals delineated in the individual's ITP. (15) “Secretary” means the Secretary of Health, or the Secretary's designee. (16) “Small private group home” means a residence as defined in Health-General Article, §§10-514(d) and (e) and 10-518(b), Annotated Code of Maryland. (17) Therapeutic Group Home (TGH). (a) “Therapeutic group home (TGH)” means a small private group home. (b) “Therapeutic group home (TGH)” does not include a foster home that is the domicile of the foster parent. (c) “Therapeutic group home (TGH)” does not include a facility that is: (i) Owned by or leased to the State or any public agency; (ii) Regulated by the Department of Juvenile Services, Department of Human Services, or Developmental Disabilities Administration; or (iii) Organized wholly or partly to make a profit. (18) “Therapeutic milieu” means an environment that is clinically structured to provide mental health treatment in a place other than the individual's residence. #### Regulation .03 Proposal and Designation of Lead Agency. *COMAR 10.21.07.03* A. Proposal. (1) An individual or organization that proposes to provide therapeutic living services for children in a TGH shall: (a) Direct an initial inquiry for obtaining a license to the GOC, in accordance with COMAR 14.31.05.05; and (b) Submit to GOC, in accordance with COMAR 14.31.05.05, a proposal describing the: (i) Physical plant in which the children will reside; and (ii) Program service plan, as described in Regulation .05C of this chapter. (2) GOC shall designate a lead agency. B. Lead Agency. If GOC designates the Department as lead agency, on receipt of the proposal submitted under §A of this regulation, the Secretary shall notify the Director of the Administration, who shall: (1) Forward a copy of the proposal to: (a) The CSA director, if appropriate; and (b) The designated licensure unit of the Department; and (2) Within 2 weeks, send the applicant the Department application form and instructions. #### Regulation .04 License Required. *COMAR 10.21.07.04* A. Before operating a TGH, a person shall obtain a license from the Department under the provisions of this chapter and COMAR 14.31.05 for each TGH site in which children reside. B. The Secretary shall grant a license to an applicant to operate a TGH if the applicant fulfills the requirements for: (1) Licensure under COMAR 14.31.05; and (2) Service and staffing under this chapter. #### Regulation .05 Application Process. *COMAR 10.21.07.05* A. Consultation. If the Administration is the designated lead agency, an applicant for licensure for a TGH, before submitting an application, may request assistance from the designated licensure unit of the Department, the appropriate CSA director, or the Administration regarding the proper compilation of application materials and completion of the application. B. Application. An applicant for licensure of a TGH shall: (1) Submit, to the Department's designated licensure unit, a signed, notarized application on the form approved by the Department with the requirement that all questions be answered and all required documents be attached; (2) Include in the application: (a) The applicant's: (i) Name; (ii) Agency affiliation, if any; and (iii) Address; (b) Documentation: (i) Of the applicant's not-for-profit status; and (ii) That the applicant has sufficient financial resources or that sufficient resources are available to the applicant for the establishment and operation of the residence; (c) The following information about the property: (i) The street address of the location of the TGH or, if it has no street address, a description that adequately identifies the location of the property; and (ii) If the applicant does not own the property, the name and address of the owner; (d) The satisfactory fire, safety, and health inspection reports, not more than 1 year old, of the TGH that are required by the local jurisdiction; (e) Written material that describes how the applicant intends to comply with the requirements outlined in: (i) COMAR 14.31.05; and (ii) This chapter; (f) An explanation of the need for the TGH, including, if the jurisdiction in which the TGH is to be located is served by a CSA, a letter of intent that explains how the TGH meets a need identified in the Administration-approved CSA plan; (g) When applicable, documentation that the TGH will collaborate with the CSA, as required under Regulation .07 of this chapter; (h) Documentation that the TGH: (i) Is near transportation facilities, or has a plan for the provision of transportation services based on the individual's need; and (ii) Meets, or on completion will meet, general zoning requirements regarding size, density, land use, and architectural guidelines that apply to the site; and (i) The applicant's program service plan, as outlined in §C of this regulation; and (3) Forward a copy of the: (a) Application cover letter to the Administration; and (b) Application to the: (i) CSA, if the jurisdiction in which the TGH is to be located is served by a CSA; or (ii) Administration, if the jurisdiction in which the TGH is to be located is not served by a CSA. C. Program Service Plan (PSP). On the form approved by the Administration, as part of the application, a TGH shall submit a PSP that includes: (1) If appropriate, a copy of the articles of incorporation, organizational chart, bylaws, and list of the members, including officers, of the governing body; (2) Documentation that at least 1/3 of the members of either the governing body or an advisory committee includes representation of consumers, former consumers, or family members; (3) The proposed budget for the TGH; (4) A description of: (a) The number of children, as well as their age groups and other relevant characteristics, that the TGH expects to serve; (b) The geographic area to be served; (c) The goals, objectives, and expected outcomes of the program; (d) The plan for the provision of the following services: (i) Medical; (ii) Dental; (iii) Required education; (iv) Social and recreational; (v) Nutritional; and (vi) Mental health treatment; (e) The method for linkage with service providers and community resources, including, when applicable, written agreements with inpatient facilities and other providers of health, mental health, and social services; and (f) The methods by which quality, including risk management and utilization review, are assured; and (5) A list of staff positions, their job descriptions and educational and clinical training requirements, and staffing patterns, including an organizational chart detailing lines of authority and responsibility. #### Regulation .06 Governance. *COMAR 10.21.07.06* A. Governing Body. (1) A provider that is licensed by the Department under this chapter to operate a TGH shall be governed by a body that shall: (a) Carry out the responsibilities under COMAR 14.31.06.04; and (b) Either: (i) Include the membership described under §B(1) of this regulation; or (ii) Appoint an advisory committee for the TGH that includes the membership described under §B(1) of this regulation. (2) The chairman of the governing body shall maintain documentation of: (a) The legal form of organization of the operator of the TGH; (b) The minutes of all regularly scheduled meetings; and (c) Any registration required by the State Department of Assessments and Taxation to operate as a business in Maryland. B. Advisory Committee. (1) When appointing an advisory committee under §A(1)(b)(ii) of this regulation, the governing body shall assure that the committee is composed of members: (a) That reflect the cultural and ethnic profile of the community or communities being served; and (b) At least 1/3 of whom are individuals who are: (i) Currently or were previously served by a TGH or other community-based mental health program; (ii) Family members of individuals who are currently or were previously served by a TGH or other community-based mental health program; or (iii) Members of a mental health advocacy organization. (2) An advisory committee appointed under §B(1) of this regulation shall, at a minimum: (a) Establish and maintain a regular meeting schedule; and (b) Advise the governing body regarding the duties described under COMAR 14.31.06.04. #### Regulation .07 Collaboration with Core Service Agency (CSA). *COMAR 10.21.07.07* A. If the jurisdiction in which a TGH is located is served by a CSA, the governing body shall document that the program shall: (1) Submit the following information to the CSA: (a) Documentation that the program budget is adequate to support the program's ability to provide authorized services; (b) The program service plan; (c) Data that incorporate outcome measures; and (d) A yearly summary that, at a minimum, includes: (i) Relevant financial statements or documentation of an audit that certifies that the TGH is fiscally sound; (ii) Program planning and evaluation, as identified in COMAR 14.31.06.19; and (iii) Service utilization data; (2) Collaborate with the CSA in: (a) The process developed by the CSA for screening and exploring alternatives for an individual served by the TGH for whom inpatient facility admission is being initiated; (b) The CSA's protocol for resolution of conflict between the TGH and: (i) The child or family of a child served; and (ii) Another program or agency; and (c) The CSA's procedures for prevention of the appearance or occurrence of conflict of interest in the operation and oversight of the program's provision of mental health services; (3) Contract, as necessary, with the CSA; and (4) Make available to the CSA any medical records that are needed by the CSA for the purpose of: (a) Assessing the quality of care; or (b) Investigating a complaint or grievance. B. If the jurisdiction in which a TGH is located is not served by a CSA, the chairman of the governing body shall document that the program shall submit information to and collaborate with the Administration, as required under this regulation. #### Regulation .08 TGH Program Model. *COMAR 10.21.07.08* A. A TGH provides therapeutic living services: (1) For at least four but not more than eight children; (2) By providing access to a combination of developmental, diagnostic, and therapeutic mental health services; (3) When possible, in the child's community of origin; and (4) In a home-like environment. B. The chief executive officer of a TGH shall assure that a TGH: (1) Provides to each child in the TGH mental health care and treatment: (a) That can reasonably be expected to benefit the child; and (b) By an adequate staff or, under agreement, by a provider of mental health services; (2) Has sufficient staff to provide adequate supervision to the children in the TGH, including 24-hour supervision for each resident not participating in a program outside the TGH; and (3) Coordinates treatment in the TGH with the appropriate public or nonpublic educational program. C. The chief executive officer of the TGH shall assure that services are: (1) Appropriate to the cultural and psychosocial developmental needs of the child; (2) Provided by staff who: (a) As determined by the program, are appropriately credentialed and privileged; and (b) Organize and manage the therapeutic milieu to: (i) Foster clinically appropriate social, cognitive, emotional, and physical growth; (ii) Handle aggression in a nonpunitive manner that promotes growth and learning; (iii) Reinforce the child's ability to function with peers in a social environment; (iv) Model and provide opportunities for children to behave in age-appropriate ways, such as assuming responsibility for carrying out routine activities, exhibiting independence and initiative in planning their own activities, getting along with others, and demonstrating age-appropriate social skills; (v) Facilitate the child's awareness of appropriate behavior in a predictable, constructive, and timely manner; and (vi) Help children to make choices and to negotiate disagreements among themselves, rather than resolving conflicts for them; (3) Provided in an environment that is: (a) Consistent with existing standards of program design; and (b) Organized consistent with the learning styles and developmental needs of the child; and (4) Designed to foster positive relationships between the child and the child's parents or guardians and, if other than a parent, the child's primary caretaker, and the anticipated post-placement caretaker. #### Regulation .09 Eligibility, Application, and Admission. *COMAR 10.21.07.09* A. Eligibility. (1) A child is eligible for admission to a TGH if: (a) The child: (i) Has a mental disorder; (ii) Is or should be receiving treatment for the mental disorder; (iii) Because of the mental disorder, requires residential services not available in the home; (iv) Needs 24-hour supervision in a structured private group home; (v) Has the ability to understand and states, in writing, a willingness to comply with the rules and regulations of the TGH; and (vi) Has the ability to act appropriately under emergency conditions; and (b) There is no less restrictive form of treatment that is consistent with the welfare and safety of the child. (2) A TGH may not admit or retain as a resident a child if the child: (a) Has a primary diagnosis of alcoholism, drug addiction, or severe brain damage; (b) Shows current violent or antisocial behavior; or (c) Has cognitive deficits that severely limit the child's ability to benefit from the treatment modalities provided. B. Application for Admission. An applicant to a TGH shall use an application form which outlines the following requirements: (1) Identifying data, including but not limited to: (a) Name, date of birth, sex, legal domicile, and current residence of the child; (b) Names, addresses, and telephone numbers of persons or agencies having legal care or custody of the child; and (c) Documentation of the child's custody status, including, if relevant, documentation of agreements regarding responsibility for financial support and health care; (2) Authorization to release information signed by the child's parent or guardian; (3) Based on a comprehensive mental health assessment by an individual authorized, under Health Occupations Article, Annotated Code of Maryland, to formulate a psychiatric diagnosis, a statement including: (a) The psychiatric diagnosis and the rationale for the diagnosis; (b) An explanation of why the child would benefit from the treatment and related services provided in and by a TGH; (c) The treatment goals for the child, if TGH placement occurs; (d) Any history of violence or trauma, and the potential for current violent behavior; and (e) Documentation that the child meets the eligibility criteria outlined in §A of this regulation; (4) A recent history of the child's: (a) Mental health treatment, including relevant psychiatric and psychological evaluations; (b) Family status; (c) Education, including documentation of a handicapping condition, if any; and (d) Involvement, if any, with community agencies; (5) Relevant medical records; and (6) Unless the child has a guardian that is a State agency, a written and signed statement that, at the time of application for admission, the child's parent or guardian: (a) Agrees to the placement; (b) Agrees to the rules and regulations of the TGH; and (c) Enters into an agreement regarding the responsibility for payment for the child's medical and mental health care. C. If, under §B(3) of this regulation, the child has a history of violent behavior, TGH staff shall be permitted to plan and collaborate with the clinical referral source to develop a treatment plan which addresses the current potential for violent behavior. D. Admissions Procedures. (1) An applicant for admission of a child to a TGH shall: (a) Submit an application for admission, as described in §B of this regulation, to the TGH chief executive officer; and (b) Forward copies of the application to the Administration and the CSA, if the jurisdiction in which the child's parent or guardian resides is served by a CSA. (2) On receipt of an application for admission to the TGH, the TGH chief executive officer, in collaboration with appropriate TGH mental health professional staff, may conduct a pre-admission interview with: (a) The applicant for admission to a TGH; (b) If other than the applicant, the: (i) Child; (ii) Child's parent or guardian; or (iii) Referring agency; and (c) As appropriate, past or current providers of the following services: (i) Educational; (ii) Social; and (iii) Mental health treatment. (3) Within 2 weeks of receipt of an application for admission, the TGH chief executive officer shall: (a) In consultation with clinical and residential staff at the TGH and based on the eligibility criteria outlined under §A of this regulation, determine whether the TGH is the appropriate setting for the child; (b) Notify the applicant of the determination; (c) If the determination is that the TGH is not appropriate for the child, notify the applicant of: (i) The reason for the determination; and (ii) A recommendation regarding the appropriate level of care; and (d) Notify the appropriate CSA director and the Administration of the determination. (4) If the TGH chief executive officer approves the application for admission, the chief executive officer shall give to the applicant written notice of: (a) If a bed is available, the date of admission to the TGH; or (b) If a bed is not available within the following 21 days: (i) The child's position on the TGH's waiting list; (ii) The process for reviewing the child's waiting list status; and (iii) Information about appropriate placement alternatives. #### Regulation .10 Required Services. *COMAR 10.21.07.10* The chief executive officer of a TGH shall assure that children in the TGH receive: A. Physical and dental examinations, care, and treatment for children who are: (1) Eligible for Medical Assistance, services through the managed care organization, as required by COMAR 10.09.67; or (2) Not eligible for Medical Assistance, through written agreements with appropriate providers, as indicated under COMAR 01.04.04.19; B. From an appropriate public or nonpublic program, education, as indicated under COMAR 01.04.04.18B; and C. From a mental health professional: (1) Regular individual mental health treatment, according to the ITP developed by the mental health professional; and (2) As required by the child's ITP, needed evaluation and consultation. #### Regulation .11 Evaluative Services Provided by the TGH. *COMAR 10.21.07.11* A. Therapeutic Milieu. The clinical coordinator, as defined in Regulation .14C of this chapter, shall assure maintenance of the therapeutic milieu in order to foster achievement of a child's treatment goals. B. Diagnosis. Within 1 week of a child's admission to the TGH, the clinical coordinator shall ensure that a staff member authorized under the Health Occupations Article, Annotated Code of Maryland, and credentialed and privileged by the program to formulate a psychiatric diagnosis, shall: (1) Formulate and document in the child's medical record a diagnosis based on a face-to-face assessment of the child, that includes: (a) A description of the presenting problem; (b) Relevant history; (c) Mental status examination; and (d) The rationale for the diagnosis; or (2) Affirm the psychiatric diagnosis documented as part of the application for admission under Regulation .09B(3) of this chapter that has been entered in the child's medical record. C. Assessment. Using the evaluation materials submitted as part of the application for admission, before or within 1 week of the child's admission to the TGH, the TGH clinical coordinator shall assure the completion of an assessment that includes, as indicated, an assessment of the child's: (1) Developmental history; (2) Educational history; (3) Family history and evaluation of current family status, including legal custody status; (4) Home environment; (5) Social, emotional, and cognitive development; (6) Motor, language, and self-care skills development; (7) History, if any, of: (a) Substance abuse; (b) Physical or sexual abuse; and (c) Home or community violence; (8) Local department of social services or Department of Juvenile Services involvement, if any; (9) Mental status; and (10) Medical history and needs, including, if any, history of allergies, neurologic disorders, and communicable diseases. D. Initial Brief Treatment Plan. Not later than 1 week following admission, the TGH clinical coordinator shall prepare an initial brief treatment plan: (1) Based on the: (a) Application materials submitted as required under Regulation .09B of this chapter; and (b) Assessment under §C of this regulation; (2) In collaboration with: (a) The child; (b) The primary caretaker; (c) Appropriate TGH staff; and (d) As appropriate and with proper consent, interested and available community treatment providers; and (3) That includes, at a minimum: (a) The treatment goals expressed by the referring agency, if any; (b) The process of orientation to the TGH; and (c) Initial expectations regarding the child's adjustment to residential placement. E. TGH Individual Treatment Plan (ITP). (1) Treatment Team. (a) At a minimum, the following individuals shall participate on a child's treatment team: (i) The TGH psychiatrist; (ii) The clinical coordinator; (iii) The child's case coordinator; and (iv) Other TGH staff who are involved in providing services to the child and family. (b) The clinical coordinator shall invite, as appropriate and with proper consent, family members and community-based providers of services to the child, including but not limited to school and mental health treatment staff, to participate as members of the child's treatment team. (2) Initial ITP. Within 30 days after a child is admitted to a TGH and based on the initial brief treatment plan and current observations and reports, the TGH clinical coordinator shall prepare an ITP to be addressed by TGH staff: (a) In collaboration with: (i) The child; (ii) The treatment team; (iii) If present and as appropriate, the primary caretaker, family and others involved in the child's care; and (iv) Other providers of care or treatment; (b) That identifies the: (i) Providers of mental health treatment; (ii) Providers of medical and dental care; (iii) Educational program; and (iv) TGH case coordinator; (c) That is coordinated with the child's: (i) Individualized educational plan (IEP), when applicable; (ii) ITP prepared by the providers of mental health treatment; and (iii) Medical care provider; (d) That documents the following information: (i) Based on the physical examination required under Regulation .10A of this chapter, somatic care recommendations, including any medication prescribed, and precautions; (ii) Nutritional requirements and limitations, if any; and (iii) Essential medical or non-medical treatments or procedures, if any; (e) That includes, at a minimum: (i) The psychiatric diagnosis, as documented under §B of this regulation, in consultation with the providers of mental health treatment; (ii) A description of the child's current behavior, symptoms, and level of functioning that includes the child's presenting strengths, needs, and treatment expectations and responsibilities; (iii) A description of the family's or significant others' strengths and needs, as they relate to the child; (iv) When appropriate, identification of particular behaviors that result or may be expected to result from the child's psychiatric symptoms; (v) Based on consultation with the providers of education and mental health treatment, short-term and long-term mental health treatment goals that are outcome-oriented and that are stated in behavioral, measurable terms; (vi) As needed, other goals related to family, socialization and recreation, and activities of daily living; and (vii) Identification of any medication prescribed for the treatment of a mental disorder and required monitoring of same; and (f) That specifies treatment strategies to be provided by TGH staff, including: (i) Recommended modality and frequency of interventions; (ii) Target dates for goal achievement; (iii) The designation of TGH staff responsible for implementing the elements of the plan; and (iv) When appropriate, identification of, referral to, and collaboration with other services to support the child's treatment. (3) ITP Review. As frequently as necessary, as determined by the TGH clinical coordinator, and, at a minimum of every 90 days, at a treatment team meeting with, unless clinically contraindicated, the child, the clinical coordinator shall: (a) Review and record in the child's medical record: (i) The child's progress toward the accomplishment of previously identified mental health treatment and other goals; (ii) Goal changes based on a review of progress; (iii) Changes in treatment strategies; and (iv) Changes in diagnosis; and (b) Communicate the results of the treatment plan review to: (i) The child, if the child did not attend the ITP review team meeting; (ii) The primary caretaker, if present; (iii) Relevant program staff; and (iv) The providers of mental health treatment services. (4) Signature of the ITP and ITP Reviews. (a) The child and the child's parent or guardian shall sign or tape-record agreement or disagreement with the ITP and reviews. (b) A child's primary caretaker, if other than the parent or guardian, shall sign or tape-record acknowledgment of the ITP and reviews. (c) In addition, the following TGH staff shall sign the ITP and reviews: (i) Psychiatrist; (ii) Clinical coordinator; and (iii) Case coordinator. (d) If the child’s parent, guardian, or primary caretaker does not sign the ITP or ITP reviews, staff shall document efforts to obtain the signature and reason why the signature could not be obtained. F. Continuing Evaluation. (1) Contact Notes. Staff involved in the contact shall document in the child's TGH medical record all significant clinically relevant face-to-face, telephone, and written contacts with or about the child, including the dates, locations, and types of contacts. (2) Progress Summary Notes. At least every 2 weeks, a child's case coordinator shall: (a) Record in the child's TGH medical record a progress summary note regarding: (i) The delivery of services specified by the ITP; (ii) Progress toward goal achievement; (iii) Changes in the individual's status; and (iv) If applicable, suggested changes in treatment goals and services delivered; and (b) Assure that the child's needs and progress are communicated to those listed under §E of this regulation. #### Regulation .12 Treatment and Support Services Provided by the TGH. *COMAR 10.21.07.12* A. Case Coordination. The TGH clinical director shall assure that a child's case coordinator: (1) Integrates appropriate therapeutic and educational services into the child's ITP by coordinating with the child's previous placement provider, school, clinic or other mental health providers, and, if any, employer; (2) Makes home visits and meets with the primary caretaker to ameliorate problems in the home and facilitate reunification; and (3) Participates in treatment team meetings for the purposes of collaborating in service delivery and advocating for the child. B. Group Therapy. Appropriately credentialed and privileged TGH staff or consultants shall, at least weekly at the TGH, provide group therapy that, unless otherwise indicated in the child's ITP, includes every child in the TGH. C. Pychoeducational Groups. As required by the child's ITP, the child's care coordinator shall assure that the child has the opportunity to participate in appropriate groups for children who have special needs, including but not limited to groups for children who have been affected by: (1) Substance abuse; (2) Sexual assault; (3) Physical abuse; or (4) Home or community violence. D. Medication Services. (1) The TGH clinical coordinator shall assure that medications prescribed for a child are stored securely and made available to the child as appropriate. (2) Administration. If a child's ITP requires that TGH staff administer medication, the following requirements apply: (a) Only an individual licensed under the Health Occupations Article, Annotated Code of Maryland, to administer medication may do so; and (b) Only a licensed practical nurse or a registered nurse may delegate the administration of medication according to the provisions of COMAR 10.27.11. (3) Monitoring. When required by the child's ITP, a TGH staff member privileged to do so shall provide the following services: (a) Supporting the child's self-administration of prescribed medication; (b) To the extent possible, monitoring compliance with instructions appearing on the label; (c) Reading the label to assure that each container of medication is clearly labeled with the child's name, the contents, directions for use, and expiration date; (d) Observing and documenting any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicating to the prescribing authority and TGH psychiatrist any problems that possibly may be related to the medication; and (e) Reinforcing education on the role and effects of medication in symptom management. E. Health Promotion and Training. (1) When indicated in the child's ITP, TGH staff privileged to do so shall provide basic health teaching in the following areas: (a) Nutrition; (b) Exercise; (c) Dental care; (d) Substance abuse prevention; and (e) Prevention of injury and illness at home and in the community. (2) The clinical coordinator shall assure the provision of training in communicable disease prevention, including prevention of sexually transmitted diseases and blood-borne pathogens, including HIV/AIDS. F. Discharge Procedures. A TGH licensee shall: (1) Carry out discharge planning in accordance with COMAR 14.31.06.17; and (2) If appropriate, forward a copy of each discharge plan to the appropriate CSA and the Administration. #### Regulation .13 Residential Services. *COMAR 10.21.07.13* A. General. The chief executive officer shall assure that: (1) Basic life needs are met, according to the requirements of COMAR 01.04.04.17; and (2) Communication and visiting policies and daily routines are implemented according to the requirements of: (a) Health-General Article, §§10-702 — 10-703, Annotated Code of Maryland; (b) COMAR 10.21.09; and (c) COMAR 14.31.06.09B. B. Supervision. The chief executive order shall assure that TGH staff, as defined in Regulation .14 of this chapter, provides supervision for each resident not participating in a program outside the TGH, as follows: (1) During hours that children are awake and in the TGH, at least one staff member shall be present for every three children in the TGH; (2) During children's sleeping hours, at least one awake staff member shall be present in the TGH; and (3) At all times, at least one staff member shall be available, at the request of on-duty staff, to arrive at the TGH within 1 hour of the request. C. Activity. As required under COMAR 14.31.06.05H, the clinical coordinator shall assign staff to plan and implement daily activities that utilize the therapeutic milieu to foster clinically appropriate social, cognitive, emotional, and physical growth, including but not limited to: (1) Group and self-directed leisure activities, both on-site and off-site, including activities related to sports and the arts; (2) Working with the child to develop an activities schedule, including: (a) Weekend and vacation plans; and (b) Activities that support the child's cultural interests; and (3) Developing linkages with and supporting a child's participation in community activities. D. Homework. Child care staff shall supervise and assist a child with homework: (1) Based on the child's needs; and (2) By coordinating with the school. E. Independent Living Skills. As required under COMAR 14.31.06.12C, in order to assist a child to develop the skills required to live independently as an adult, and as appropriate to a child's age and ability, the chief executive officer shall assign TGH staff to provide activities related to: (1) Homekeeping, including: (a) Meal preparation, including: (i) Menu planning; (ii) Shopping; (iii) Cooking; and (iv) Cleaning up; (b) Laundry; and (c) Basic housekeeping; (2) Personal hygiene; (3) Money-management, including basic banking knowledge; (4) Self-preservation; and (5) Accessing community resources, including locating and using public transportation. F. Work Experience. A TGH that arranges a work experience for a child shall follow the procedure in COMAR 14.31.06.12D. #### Regulation .14 Staff. *COMAR 10.21.07.14* A. Required Staff. The governing body of a TGH shall assure that TGH staff is sufficient in numbers and qualifications to: (1) Carry out the TGH program service plan described in Regulation .05C of this chapter and program model described in Regulation .08 of this chapter; (2) Provide the services, including supervision and staff-to-child ratio, required under Regulations .12 and .13 of this chapter; and (3) Carry out the requirements of the ITPs of the TGH residents. B. Chief Executive Officer. The governing body shall employ a TGH chief executive officer who: (1) Meets the qualifications and experience required under COMAR 14.31.06.06A; (2) Is on duty at the TGH for the amount of time necessary to carry out the duties outlined in this chapter and, at a minimum, 20 hours per week; (3) Is responsible for credentialing and privileging staff; (3-1) Is responsible for administrative oversight for, at a minimum: (a) Fulfilling the administrative requirements under COMAR 14.31.05; (b) Assuring compliance with this chapter; (c) Maintaining sufficient staff, including recruiting, hiring, training, scheduling, and terminating; (d) Assuring the availability, 24 hours per day, 7 days per week, of a TGH psychiatrist; (e) In collaboration, when appropriate, with the clinical coordinator, assuring that all staff are appropriately supervised; (f) In collaboration with the clinical coordinator and program staff, identifying staff training needs and the provision of inservice training, as required under COMAR 14.31.06.05F, and, in addition, assuring a minimum level of staff competence in at least the following: (i) Understanding mental disorders and treatment modalities, including medication; (ii) Use of seclusion, restraint, and quiet room, as governed by COMAR 10.21.12 and 10.21.13; (iii) Verbal de-escalation and aggression management techniques and procedures; (iv) Appropriate response to communicable diseases and use of universal precautions; (v) Emergency preparedness and evacuation plan; and (vi) Implementation of children's rights; (g) Quality management; (h) Developing and implementing the budget; (i) Maintaining the physical plant; and (j) Keeping the governing body informed of, at a minimum, the program's licensure status and performance; (4) May carry out the duties of the clinical coordinator, as described under §C of this regulation, if the chief executive officer is: (a) A mental health professional; (b) On duty at the TGH at least 40 hours per week, 20 hours of which must be during times when the children or adolescents are normally on-site; and (5) If carrying out the duties of the clinical coordinator, shall hire an additional mental health professional for an additional 20 hours per week to assist with the duties described under §C of this regulation. C. Clinical Coordinator. If the chief executive officer is not the clinical coordinator, the chief executive officer shall hire a clinical coordinator who is: (1) A mental health professional; (2) On duty at the TGH at least 20 hours per week during times when the children or adolescents are normally on-site; and (3) Responsible for, at a minimum: (a) Development of treatment procedures, including admission and discharge procedures; (b) Development of the ITP and ITP reviews, including appropriate coordination with a child's: (i) IEP; (ii) ITP developed by the providers of mental health treatment; and (iii) Medical care providers; (c) Interpreting the children's assessments and evaluations to staff; (d) Establishing and maintaining linkage with schools and community treatment providers; (e) Establishing protocols for medical and psychiatric emergencies and crisis response plans; (f) Providing clinical supervision of staff; and (g) If assigned by the TGH chief executive officer, maintenance of the therapeutic milieu described in Regulation .08C(2)(b) of this chapter. D. TGH Psychiatrist. The chief executive officer shall assure the availability of a psychiatrist who: (1) Has completed a residency in child psychiatry in an accredited program; (2) As specified in the employment or consultant contract, is available: (a) For the amount of time necessary to carry out the duties outlined in §D(3) of this regulation; and (b) To respond to emergencies 24 hours per day, 7 days per week; and (3) Is responsible for: (a) Participation in the screening, assessment, admission, and discharge processes; (b) Formulating and documenting a diagnosis, according to Regulation .11B of this chapter; (c) Participation in the development and signing of a child's ITP and ITP reviews; (d) Clinical supervision of those cases requiring face-to-face medical review; (e) Consulting with staff regarding the maintenance of the therapeutic milieu; (f) Review of medication utilization and corrective feedback when utilization is found to be inappropriate; and (g) Medical aspects of quality management. E. Case Coordinator. The TGH chief executive officer shall employ a sufficient number of case coordinators, each of whom is: (1) Either a: (a) Mental health professional; or (b) Residential care specialist who: (i) Has a minimum of a high school diploma or equivalent; and (ii) Is supervised by a mental health professional; (2) Available to be with the child, on site in the TGH, at least 4 days per week; and (3) Responsible for the duties delineated under Regulation .12A of this chapter. F. Residential Care Specialist. The TGH chief executive officer shall employ a sufficient number of residential care specialists who: (1) As determined by the chief executive officer, have sufficient qualifications and experience to carry out the duties of the position; (2) Have training applicable to the service, including, at a minimum, training outlined in §B(3)(g) of this regulation; (3) As permitted under the Health Occupations Article, Annotated Code of Maryland, and as privileged by the program, are available to carry out the residential services delineated under Regulation .13 of this chapter. G. Program Coordinator. The TGH chief executive officer may employ a program coordinator, who shall be a mental health professional, to manage the therapeutic milieu as outlined in §C(3) of this regulation. #### Regulation .15 Data Submission. *COMAR 10.21.07.15* A TGH shall report the required data in the form and at the times specified by the Administration. #### Regulation .16 Rights. *COMAR 10.21.07.16* TGH staff shall explain to a child enrolled in a program and to the child's parent, guardian, and, if other than the parent, the primary caretaker, of the child's rights as set forth in Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland. #### Regulation .17 Grievances. *COMAR 10.21.07.17* A. A TGH shall develop and implement a process for the prompt and objective resolution of grievances that may be presented by a child or by a child's parent, guardian, or primary caretaker. B. The TGH shall prominently display, in accessible centralized locations, the written description of the grievance procedure. ### Chapter 08 — Services for Mentally Ill Hearing Impaired Patients in Facilities **Authority:** Health-General Article, §10-204, Annotated Code of Maryland **Administrative History:** Effective date: January 8, 1990 (16:26 Md. R. 2792) #### Regulation .01 Scope. *COMAR 10.21.08.01* The following regulations govern the provision of services for hearing impaired mentally ill patients within the Administration's facilities and the designated inpatient hearing impaired unit. #### Regulation .02 Definitions. *COMAR 10.21.08.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Maryland Department of Health Administration. (2) “Audiologist” means an individual who is authorized to practice audiology under Health Occupations Article, Title 2, Annotated Code of Maryland. (3) “Certified interpreter for hearing impaired persons” means an interpreter who possesses at the minimum a Comprehensive Skills Certificate issued by the Registry of Interpreters for the Deaf. (4) “Documented history of deafness or hearing impairment” means a documented diagnosis of hearing impairment made by an audiologist or by a Board-eligible or Board-certified otolaryngologist. (5) “Facility” means an inpatient or residential treatment program operated directly by the Administration. (6) “Gross testing” means either an interactive process which screens a person's ability to follow ordinary conversation or pure tone audiometric screening. (7) “Hearing aid” means any instrument or device designed for or represented as aiding, improving, or correcting hearing and any parts, attachments, or accessories of this instrument or device. (8) “Hearing impaired individual” means a person with an impairment so severe that with or without amplification, the processing of linguistic information through hearing is impaired. (9) “Individual treatment plan” means the plan of care identified for each patient as outlined in COMAR 10.21.03. (10) “Mental illness” means an illness resulting from a psychiatric disorder and does not include a primary diagnosis of alcohol or drug abuse or developmental disability. (11) “Otolaryngologist” means a physician identified by the State Board of Physician Quality Assurance as a specialist in otolaryngology as set forth in Health Occupations Article, §14-704, Annotated Code of Maryland. (12) “Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland. (13) “Pure tone audiometric screening” means the pure tone air conduction screening procedure used to rapidly and effectively identify a patient with a hearing impairment that interferes with or has the potential for interfering with communication. (14) “Qualified allied health professional” means the staff assigned by the facility and trained by an audiologist in procedures outlined in this chapter. (15) “Rinne and Weber testing” means the tuning fork test used to differentiate between conductive and sensory-neural hearing losses. (16) “Speech-language pathologist” means an individual who is authorized to practice speech-language pathology under Health Occupations Article, Title 19, Annotated Code of Maryland. (17) “Speech reading” means the use of visual cues in determining what the speaker is saying and may also be referred to as lip reading. (18) “Unit” means the inpatient unit of the institution designated by the Administration created specifically to treat those patients having both a mental illness and a hearing impairment. #### Regulation .03 Identification of Hearing Impaired Patients. *COMAR 10.21.08.03* A. Patients admitted to facilities shall be screened for hearing impairment. B. Gross Testing of Hearing Sensitivity. (1) At each facility, an examination shall be performed for gross testing of hearing sensitivity on all newly admitted patients within 24 hours of admission. This examination shall be performed: (a) By a physician or a qualified allied health professional; and (b) According to the following protocol: (i) Testing shall occur consistently at a fixed distance from the speaker at all times; (ii) In order to prevent speech reading which could be interpreted as a false positive, the speaker's face may not be in view by the patient while testing is in process; and (iii) Non-English speaking patients shall be tested in the language the patient is known to speak or is believed to comprehend. (2) Testing performed in conformance with §B(1) of this regulation shall be repeated within 15 days after admission on all patients not already tested with a pure tone screening audiometer. (3) Each test performed in compliance with this regulation shall be documented in the patient's chart. (4) Once a hearing impairment is suspected: (a) Rinne and Weber testing shall be performed; and (b) Referral shall be made for audiometric screening. C. Audiometric Screening. (1) Patients with Suspected Hearing Impairment. (a) Pure tone audiometric screening shall occur within 3 working days from the period specified in §B(1), of this regulation, for any patient who: (i) Is suspected of having a hearing impairment on the basis of any of the above tests; (ii) Was unresponsive because of a possible hearing impairment; or (iii) Responded in a manner that may be construed as a mental disorder, but may be confused with a possible hearing impairment. (b) Patients suspected of having a hearing impairment on the basis of the latest pure tone audiometric screening shall be referred promptly but in not more than 5 working days to an audiologist or an otolaryngologist. Referral shall be documented in the patient's chart. (c) Upon recommendation by either the otolaryngologist or audiologist, further evaluation by a speech-language pathologist shall be conducted. (d) If the audiometric screening in this section is used as the initial screening test, that audiometric screening shall be sufficient testing on admission unless otherwise ordered. (2) Patients Not Identified as Hearing Impaired. As soon as possible, but within 90 days after admission, each patient who has not already been screened with an audiometer shall be so evaluated. (3) Each patient's annual physical examination shall include audiometric screening. The screening results shall be documented in the patient's chart. (4) Procedures for Audiometric Screening. (a) The audiometric screening shall be performed in accordance with the standards outlined in Regulations .04 and .05 of this chapter. (b) The audiometric screening shall be administered by either: (i) A physician trained to screen hearing according to the protocol established in this chapter; (ii) An audiologist; or (iii) Appropriately and periodically trained allied health care staff, under the supervision and monitoring of an audiologist. (c) An audiologist shall determine the facility's training protocol and frequency of training for allied health care staff. At a minimum, training shall occur at least once a year. D. Patients Exempted from Audiometric Screening. If the patient has a history of hearing impairment as defined in Regulation .02B(8) of this chapter and documented by an audiologist or physician, the screening procedure identified in §B and C of this regulation is not required within the first year after admission. E. Treatment recommendations related to the patient's hearing impairment made by either an audiologist, otolaryngologist, or speech pathologist, shall be incorporated in the patient's Individual Treatment Plan. F. Provision and Maintenance of Hearing Aids. (1) The patient and appropriate staff on each shift shall receive, in accordance with a plan developed by an audiologist, instructions on the care, use, and inspection of the hearing aid by staff referenced in §C(4)(b)(i) and (ii) of this regulation or the hearing aid vendor. (2) Designated staff, as identified in the Individual Treatment Plan, shall be responsible for ensuring daily monitoring of hearing aids, and implementing timely repair and immediate replacement of batteries. (3) Identification of the need for replacement as well as the replacement of the patient's hearing aid shall be documented in the patient's record. (4) Denial of hearing aid replacement by the treatment team or the patient's refusal to accept a hearing aid shall be documented and be reevaluated at a minimum of every 3 months. (5) The facility shall provide a hearing aid to the patient when an otolaryngologist or audiologist determines that a patient would benefit from amplification and related accessories. Payments for aids shall follow the Administration's policy on payment for medical devices. #### Regulation .04 Standards for Identification Audiometry. *COMAR 10.21.08.04* A. Staff, as defined in Regulation .03C(4)(b), of this chapter, shall conduct manually administered, individual pure tone air conduction screening procedures for identification audiometry on each patient with a developmental age of 3 years or older. The following apply: (1) Patients with a developmental age of less than 3 years shall be referred to an audiologist for an evaluation. (2) Group screening may not be conducted on any patient. B. Pure tone testing shall use test frequencies at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz. Screening levels shall be 20dB hearing level at all frequencies tested. C. Audiometers Used for Screening Purposes. (1) For either a limited range or a narrow range audiometer, audiometers shall meet the requirements found in “Specifications for Audiometers” (ANSI S3.6-1969, American National Standards Institute), which is incorporated by reference. (2) Audiometers shall be calibrated by an appropriately and professionally trained person at least annually. (3) Sound pressure at the ear phones shall be checked at least every 3 months. (4) Daily listening checks shall be performed to determine that the audiometer is grossly in calibration and that no defects exist in major components. (5) An audiologist shall instruct support personnel in the proper handling and operation of audiometric equipment in order to minimize the need for repairs and to improve test accuracy. D. In accordance with Regulation .05 and the requirements found in “Criteria for Permissible Ambient Noise During Audiometric Testing” (ANSI S3.1-1977 American National Standards Institute), which is incorporated by reference, ambient noise levels may not exceed 41.5 dB Sound Pressure Level (SPL) at 500 Hz, 49.5 dB SPL at 1000 Hz, 54.5 dB SPL at 2000 Hz, and 62 dB SPL at 4000 Hz when measured using a sound level meter with octave-band filters centered on the screening frequencies. E. Nonresponse to the recommended screening levels at any frequency in either ear shall constitute failure. F. Failures shall be rescreened within the same screening session, if possible. G. Failures on rescreening shall be referred for an audiologic evaluation by an audiologist. #### Regulation .05 Requirements for the Acoustical Environment. *COMAR 10.21.08.05* The test tones listed in this regulation shall meet the allowable octave-band ambient noise levels which are noted in the following table taken from page 5 of the May 1985 ASHA journal: Test frequency 500 1000 2000 4000 Octave-band cutoff 300 600 1200 2400 Frequencies 600 1200 2400 4800 Octave-band level: Ear covered with earphone mounted in MX-41/AR cushion 21.5 29.5 34.5 42 Plus ASHA screening level 20 20 20 20 Resultant maximum ambient noise level allowable for ASHA screening 41.5 49.5 54.5 62 #### Regulation .06 Springfield Hospital Unit for Hearing Impaired Patients. *COMAR 10.21.08.06* A. Transfer Criteria. To be transferred to the unit, each patient shall: (1) Meet the statutory criteria for admission as set forth in Health-General Article, §10-609 — 10-619, Annotated Code of Maryland, and other applicable regulations related to the involuntary and voluntary admissions to facilities. (2) Have documentation of deafness or a hearing impairment. (3) Currently be using visual, manual, or tactile modes of communication which include but are not limited to American sign language, finger spelling, or speech reading, or be capable of being trained in the use of those methods. (4) Be 14 years old or older. Patients 14 to 18 years old shall reside in: (a) A separate inpatient residence designated for minors and attend the day program of the hearing-impaired unit if the: (i) Treatment teams of the unit and of the minor's inpatient residence approve; (ii) Approval is documented in the progress notes and the Individual Treatment Plan; and (iii) Individual Treatment Plan is not in conflict with the Individual Educational Plan; (b) The unit if the: (i) Unit treatment team approves; and (ii) Individual plan for treatment indicates the need for placement on the unit. (5) Be capable, with auxiliary aids, if necessary, of participating in professionally developed and supervised therapies, experiences, and activities provided by the unit. (6) Have documentation in that patient's record that the patient does not object to participation on the unit, based on information necessary to make an informed judgment. B. Referral Procedures to the Unit After a Patient is Admitted to a Facility. (1) Referral procedures for facilities shall be established by the Administration. (2) Unit staff, in consultation with the treating physician, shall: (a) Follow the Administration's referral procedures; and (b) Within 7 days of a determination of hearing impairment by history or pure tone audiometric screening, determine the appropriateness of transfer of that patient to the unit. C. Unit Personnel and Training. (1) The unit shall be directed by and include a complement of professional staff who have training or experience, or both, in working with hearing impaired mentally ill persons. (2) Unit staff shall develop and maintain skills relevant to the provision of services for hearing impaired persons which include, but are not limited to, training in the psychosocial needs of hearing impaired persons and instruction in American sign language. A credentialing process to review the continuing education program for unit staff shall be determined by the Administration. (3) Certified interpreters for hearing impaired patients, or other staff who possess equivalent qualifications as determined by a certified interpreter designated by the facility for that purpose, shall be on duty on the unit 24 hours a day. (4) Facility staff may not be scheduled to provide interpreter services and any other services at the same time. #### Regulation .07 Determination of Placement. *COMAR 10.21.08.07* A. Each hearing impaired patient in a facility, regardless of other handicapping conditions, shall be referred for evaluation for transfer to the unit pursuant to this regulation and Regulations .06 and .08A of this chapter. The following apply: (1) The referring facility's treating physician shall refer any: (a) Previously diagnosed hearing impaired patient to the unit within 72 hours of admission; or (b) Patient newly identified as hearing impaired pursuant to this chapter, within 72 hours of identification. (2) The unit staff, in consultation with the patient's treating physician at the referring facility, shall assess the appropriateness of the transfer, including but not limited to the criteria listed in Regulation .06A of this chapter. (3) The assessment and decision regarding transfer of the patient shall be documented and sent to the referring facility by the unit's assessment team within 7 working days of referral. (4) The decision regarding transfer and its rationale shall: (a) Become a part of the permanent record; and (b) Include the names and titles of the assessment team members. (5) If, after referral and assessment, the patient's transfer to the unit is denied, the decision and its rationale shall be documented in the patient's chart by the unit's director or unit director's designee. B. If the decision is made to transfer the patient to the unit, the transfer shall occur not later than 2 working days after the determination to do so, unless a bed is not available on the unit. C. The unit shall establish and maintain a waiting list for patients who have been accepted into the unit and are awaiting transfer. D. The date of entry onto the waiting list shall determine placement on the waiting list, except that priority shall be given to transfer patients from areas of known shortage of resources for mentally ill hearing impaired persons. E. Decisions related to priority transfers shall be made by the unit director or the unit director's designee. #### Regulation .08 Services for Hearing Impaired Patients Not in the Unit. *COMAR 10.21.08.08* A. Unless the age of a minor hearing impaired patient precludes transfer to the unit, the referring facility's treating physician shall refer the patient for evaluation to the unit at least every 60 days in order to: (1) Reevaluate the appropriateness for the transfer to the unit; and (2) Obtain consultation for any appropriate treatment options. B. The facility shall provide auxiliary aids in accordance with the provisions of §504 of the Rehabilitation Act of 1973, 29 U.S.C. §794 and its implementing regulations, 45 CFR §84.52(d), which are incorporated by reference, for the hearing impaired patient to participate in the facility's professionally developed and supervised activities, therapies, and experiences. Auxiliary aids may include but are not limited to interpreter services, notetakers, special hearing assistive devices, and telecommunication devices for the deaf (TTD). #### Regulation .09 Procedure Pertaining to Complaints. *COMAR 10.21.08.09* Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism. ### Chapter 09 — Patients' Rights to Visitors **Authority:** Health-General Article, §§10-101(e) and 10-703, Annotated Code of Maryland **Administrative History:** Effective date: January 8, 1990 (16:26 Md. R. 2793) #### Regulation .01 Scope. *COMAR 10.21.09.01* These regulations govern the rights of patients in all facilities as defined in Health-General Article, §§10-101(e) and 10-703, Annotated Code of Maryland. Pursuant to Health-General Article, §10-703, Annotated Code of Maryland, and for the safety and well-being of patients, their visitors and staff members, all of these facilities shall provide public notice to patients, family members, and friends of the hours allowed for visiting on facility grounds and the conditions under which visiting is permitted. #### Regulation .02 Definitions. *COMAR 10.21.09.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Mental Hygiene Administration. (2) “Attorney” means a person licensed to practice law or the attorney's agent. (3) “Clergy” means an official of a recognized church, religious society, or congregation of any sect, order, or denomination. (4) “Disorderly manner” means conduct as defined by Criminal Law Article, §10-202, Annotated Code of Maryland. (5) “Drugs” means any medically unauthorized substance as defined by Criminal Law Article, §5-101(f), Annotated Code of Maryland. (6) “Facility” means any public or private hospital, clinic, or other institution that provides or purports to provide treatment or other services for a mental disorder, except an acute care general hospital that does not have a separately identified inpatient psychiatric service. (7) “Patient” means any individual receiving care and treatment in a facility. (8) “Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland. (9) “Professional staff” means any clinical staff who is either licensed or certified in a health care field or clinical staff in charge of a residential area. (10) “Visitor” means a person who is coming to see a patient and is not acting as an agent of the facility or the Maryland Department of Health. #### Regulation .03 Facility Visitation and Visiting Hours. *COMAR 10.21.09.03* A. All facilities shall provide a conspicuously posted notice to patients, family members, and friends of the hours allowed for visiting on facility grounds and the conditions under which visiting is permitted. B. Visitation procedures and visiting hours shall be reasonable and each facility shall allow for visiting hours for at least 1 hour per day for each day of the week. C. Each facility administrator shall be responsible for ensuring that these regulations are available for review and shall post notice of the facility's visiting hours in a prominent location. D. Visiting hours do not apply to the patient's clergy or attorney who may visit the patient at any reasonable hour. E. Visiting hours do not apply during those times a person visits the patient at the request of the treatment team. F. Patients who wish to visit with children under the age of 12 may request a suitable location from the staff for the visit. #### Regulation .04 Visitation Areas. *COMAR 10.21.09.04* A. Specific areas shall be designated as visitor areas and may be subject to supervision by facility staff. B. Patients shall have the right to converse in private subject to the restrictions of Health-General Article, §10-703(c), Annotated Code of Maryland. C. Visitors may not be allowed on the patient units without staff permission or supervision, or both. D. Visiting may not be allowed in seclusion rooms. #### Regulation .05 Procedures Pertaining to Visitors. *COMAR 10.21.09.05* A. Staff may not provide child care services for visitors. B. Visitors who leave children unattended and without adequate supervision shall be asked to correct the situation or shall be expected to terminate the visit immediately. #### Regulation .06 Visitor Behavior. *COMAR 10.21.09.06* A. Specific visitor behaviors that are prohibited include, but are not limited to: (1) Verbal or physical abuse or both of staff or patients; (2) Drinking of alcoholic beverages; (3) Use of drugs; (4) Distribution of alcoholic beverages or drugs; (5) Intoxication when on the premises; (6) Disregard for patient or staff safety; (7) Assaultive behavior; or (8) Acting in a disorderly manner. B. The staff may ask visitors to remove from the facility any items or to submit the items to search. Specific notice to this effect shall be posted conspicuously at all times. #### Regulation .07 Procedures for Removal of Visitors. *COMAR 10.21.09.07* A. Professional staff shall request any visitor who jeopardizes the care or treatment of patients or the safety of patients, staff, or other visitors to leave the facility immediately and explain at the time of the request the reason or reasons for making the request. B. Whenever a visitor refuses to leave, the visitor shall be informed that the facility police or law enforcement agencies shall be called immediately to escort the visitor off facility premises. C. If the visitor continues to resist, formal arrest procedures may be initiated. D. Specific notice to this effect shall be posted conspicuously at all times. #### Regulation .08 Documentation. *COMAR 10.21.09.08* A. Incidents. (1) Any visitor behavior that leads to removal of the visitor from the premises shall be documented. (2) Any incident that requires police intervention shall be reported and documented in accordance with facility procedures. (3) Whenever a visitor is removed from the facility as a result of their disorderly manner, the treatment team shall review the incident and determine what restrictions, if any, shall be placed on the individual's future visiting privileges. (4) If restrictions are placed on an individual's future visiting privileges, the restrictions shall be subject to the requirements identified in Regulation .08B of this chapter. B. Patient Restriction. (1) Visitation shall be restricted only for a medically justified reason, and may not be used as a means of punishment. (2) The physician's order restricting patient visitation rights shall: (a) Be written as an order in the patient's permanent record; (b) Be subject to ongoing review; (c) Automatically expire after 30 calendar days; and (d) Be rewritten, if necessary, subject to the provisions of this subsection. (3) The rationale for the restriction shall be noted in the patient's permanent record and signed by the physician. (4) Restrictions shall be documented in the patient's individualized treatment plan as defined in COMAR 10.21.03. (5) A member of the treatment team shall inform the patient in a timely fashion of the restriction, its rationale, and the length of time the restriction is in effect. (6) With the consent of the patient, visitors shall be informed by the facility's Clinical Director, or the Clinical Director's designee, that a patient's visits are restricted and the length of time that the restriction is in effect. (7) Upon request and with the consent of the patient, a visitor shall receive written notification of the restriction or restrictions. #### Regulation .09 Patient's Refusal to Receive Visitors. *COMAR 10.21.09.09* A. Whenever a patient refuses visitors, the refusal shall be noted in the patient's records and may be reviewed by the treatment team. B. The patient's refusal shall be honored. C. With the consent of the patient, visitors shall be informed in a timely manner of the patient's refusal. D. When a patient refuses to receive a visitor and refuses to permit the facility to inform the visitor of the patient's refusal, the facility's communications with the visitor shall be consistent with these wishes. #### Regulation .10 Procedures Pertaining to Complaints. *COMAR 10.21.09.10* Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism. ### Chapter 10 — Psychiatric Residential Treatment Facility (PRTF) Demonstration Waiver Providers **Authority:** Health-General Article, §§10-901 and 15-130.1, Annotated Code of Maryland **Administrative History:** Effective date: April 20, 2009 (36:8 Md. R. 595) #### Regulation .01 Scope. *COMAR 10.21.10.01* This chapter sets forth the requirements for a provider of psychiatric residential treatment facilities (PRTF) Medicaid demonstration waiver services as set forth in COMAR 10.09.79. These services are: A. Caregiver peer-to-peer support; B. Crisis and stabilization services; C. Expressive and experiential behavioral services; D. Family and youth training; E. Respite services (in-home and out-of-home); and F. Youth peer-to-peer support. #### Regulation .02 Definitions. *COMAR 10.21.10.02* In this chapter, terms have the meanings stated in COMAR 10.09.79. #### Regulation .03 Approval. *COMAR 10.21.10.03* A. The Department shall grant approval to providers to be eligible to receive State and federal funds for PRTF waiver services if the provider meets the requirements set forth in this chapter. B. Application. To provide PRTF waiver services, a provider applicant shall: (1) Submit an application to the Department; (2) Submit the application on the form approved by the Department, with all questions answered and all required documents attached; and (3) Attest that the provider applicant is in compliance with the general provider requirements and specific PRTF waiver service requirements set forth in this chapter and in COMAR 10.09.36. C. Application Modification. (1) A provider that proposes to change its PRTF waiver services sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department. (2) If the Department approves the application modification, the existing provider approval shall extend to the additional site, as applicable. D. Approval. (1) The Department may grant approval to an applicant provider, for a period not to exceed 12 months, if the Department determines that the provider: (a) On the effective date of this chapter, has an existing contract with an existing care management entity under contract with a local management board in a service area; (b) Has no deficiencies that constitute a threat to the health, safety, or welfare of the individuals served; and (c) Attests that it complies with the requirements set forth in this chapter, and with the specific service requirements set forth in COMAR 10.09.79. (2) If the provider is granted approval under §D(1) of this regulation, to continue to be approved, the provider shall, within 12 months, submit documentation of compliance with the requirements set forth in this chapter, and with the specific service requirements set forth in COMAR 10.09.79. (3) The Department shall grant approval to a provider if the Department determines that the provider applicant meets the requirements set forth in this chapter and the specific service requirements set forth in COMAR 10.09.79. E. Recertification. The provider is subject to recertification by the Department every 3 years. F. Sale or Transfer of Approval. (1) The Department's approval of a PRTF waiver service provider is valid only for the provider to which the Department grants approval. (2) A provider may not sell, assign, or transfer approval to another provider. #### Regulation .04 Denial, Emergency Suspension of Approval, and Disciplinary Action. *COMAR 10.21.10.04* A. Denial of Approval. (1) If the Department proposes to deny approval to an applicant under the provisions of this chapter, the Department shall give written notice of the proposed denial to the: (a) Provider applicant; (b) Care management entity; and (c) Administrative service organization (ASO). (2) In the notice under §A(1) of this regulation, the Department shall include: (a) The date on which the Department proposes to deny approval; (b) The facts that warrant the proposed denial of approval; (c) Citation of the regulation or regulations upon which the proposed denial is based; (d) Notification that before the denial of approval, the provider may request a hearing under the provisions of COMAR 10.21.16; and (e) When feasible, notification of a case resolution conference. B. Disciplinary Action. (1) The Department may propose to take any of the following disciplinary actions against a provider: (a) Revocation of approval; (b) Suspension of approval; (c) Probation with conditions; or (d) Banning new admissions. (2) The Department may propose to take one of the actions outlined in §B(1) of this regulation if the provider: (a) Is out of compliance with the requirements of: (i) This chapter; or (ii) COMAR 10.09.79; (b) Fails to maintain financial viability; or (c) Obtains or attempts to obtain approval by fraud, misrepresentation, or the submission of false information to the Department. (3) Except under §C of this regulation, the Department shall send written notice of the proposed action not less than 45 calendar days in advance of the proposed action taken under this regulation to the: (a) Provider; (b) Care management entity; and (c) ASO. (4) In the notice under §B(3) of this regulation, the Department shall include: (a) The date on which the Department proposes to take action and, when feasible, the date of a case resolution conference; (b) The facts that warrant the proposed action; (c) Citation of the regulation or regulations upon which the proposed action is based; and (d) Notification that, before the action, the provider has the right to request a hearing under the provisions of COMAR 10.21.16. (5) If, after notice and opportunity to be heard, the Department takes disciplinary action, the provider shall, within 10 working days: (a) Notify individuals or the guardians of individuals receiving services of the action; and (b) If the program ceases operations: (i) Notify individuals or the guardians of individuals receiving services of the suspension; and (ii) Cooperate with the care management entity, child and family team, and the Mental Hygiene Administration in accessing appropriate alternate services for individuals served by the provider. C. Emergency Suspension of Approval. (1) Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a provider, the Department may order the immediate suspension of the approval of the provider and the cessation of operation. (2) If the Department takes the action under §C(1) of this regulation, the Department shall promptly give written notice of the proposed emergency suspension to the: (a) Provider; (b) Care management entity; and (c) ASO. (3) In the notice under §C(2) of this regulation, the Department shall include: (a) The proposed effective date of the emergency suspension; (b) When feasible, the date of a pre-deprivation hearing and a case resolution conference before the Department's final action; (c) The findings under §C(1) of this regulation and the reasons that support the findings; (d) Notification that: (i) Following the emergency suspension, the provider may request a hearing under the provisions of COMAR 10.21.16; and (ii) The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department. (4) If the Department suspends approval, the provider shall immediately: (a) Notify individuals or the guardians of individuals receiving services of the suspension; (b) Cooperate with the care management entity, child and family team, and the Mental Hygiene Administration in accessing appropriate alternate services for individuals in the program; and (c) Cease operations of the program. #### Regulation .05 General Conditions for PRTF Waiver Services Provider Participation. *COMAR 10.21.10.05* A. A provider of PRTF waiver services shall: (1) Provide the documentation required by the Department for initial approval and provider recertification, or as requested by the Department; (2) Be approved by the Department as meeting the requirements of this chapter and COMAR 10.09.79, and being able to provide the services set forth in COMAR 10.09.79; (3) Have a provider agreement in effect, to include adherence to quality assurance, auditing, and monitoring policies and procedures; (4) Receive training and certification as required and approved by MHA and determined to be appropriate for the level and scope of services provided; (5) Meet all the conditions for participation in COMAR 10.09.36 except as otherwise specified in this chapter; (6) Maintain general liability insurance, and provide proof of this insurance at the time of initial application to be a provider of PRTF waiver services, at recertification, and upon request by the Department; (7) Make available to the Department and federal funding agents all records, including but not limited to personnel files for each individual employed, and financial, treatment, and service records for inspection and copying; and (8) Comply with the following prohibitions against utilization of staff: (a) Unless waived by the Department in accordance with §D of this regulation, prohibit from working with the participant or the participant's family any staff, volunteers, students, or any individual who is: (i) Convicted of, received probation before judgment, or entered a plea of nolo contendere to a felony or a crime of moral turpitude or theft; or (ii) Has an indicated finding of child abuse or neglect; (b) Before permitting staff, volunteers, students, or any individual from working with the participant, or the participant's family: (i) Ensure that, at its own expense, all staff, volunteers, students, and any individual have background checks as set forth in §§B and C of this regulation; (ii) Review the results of the background checks; and (iii) Maintain the background checks in the individual's personnel file; and (c) Maintain written documentation in the individual's personnel file that the director and all direct service provider staff including, but not limited to, volunteers, interns, and students, meet the criteria set forth in this regulation. B. Required Criminal Background Checks. For each individual providing services to participants and their families in the PRTF waiver, the provider shall: (1) Before employment, submit an application for a child care criminal history record check to the Criminal Justice Information System Central Repository, Department of Public Safety and Correctional Services (DPSCS), in accordance with Family Law Article, §5-561, Annotated Code of Maryland; and (2) Request that DPSCS send the report to: (a) The director of the agency if the request is from a provider agency concerning staff, volunteers, students, or interns who will work with the participant or family; or (b) To the Department's designee, if the provider is a self-employed, independent practitioner, or the director of the agency. C. Required Check for Abuse or Neglect. For each individual providing services to participants and their families in the PRTF waiver, the provider shall: (1) Before employing any individual, submit a notarized Consent for Release of Information/Background Clearance Request form to the Department of Human Services (DHS) or a local department of social services (DSS) in the jurisdiction in which the individual lives, pursuant to COMAR 07.02.07.19; and (2) Request that DHS or the local DSS send the report to: (a) The director of the agency if the request is from a provider agency concerning staff, volunteers, or students who will work with the participant or family; or (b) To the Department's designee, if the provider is a self-employed, independent practitioner, or the director of the agency. D. Waiver of Employment Prohibitions. The Department may waive the prohibition against working with the participant or the participant's family if the provider submits a request to the Department together with the following documentation that: (1) For criminal background checks: (a) The conviction, the probation before judgment, or plea of nolo contendere to the felony or the crime involving moral turpitude or theft was entered more than 10 years before the date of the employment application; (b) The criminal history does not indicate behavior that is potentially harmful to participants; and (c) Includes a statement from the individual as to the reasons the prohibition should be waived; and (2) For abuse and neglect findings: (a) The indicated finding occurred more than 7 years before the date of the clearance request; (b) The summary of the indicated finding does not indicate behavior that is potentially harmful to the participant or the participant's family; and (c) Includes a statement from the individual as to the reasons the prohibition should be waived. #### Regulation .06 Specific Conditions for PRTF Waiver Services Providers — Respite Services. *COMAR 10.21.10.06* To be eligible to provide PRTF waiver services as a provider of in-home or out-of-home respite services under COMAR 10.09.79.06B, a provider shall: A. Meet the requirements of COMAR 10.21.27; B. Ensure that respite care specialists are: (1) 21 years old or older and have a high school diploma; or (2) Between 18 and 20 years old and in possession of at least an associate or bachelor's degree from an accredited school in a human services field; C. Ensure that: (1) In-home respite services are provided in the participant's home; and (2) Out-of-home respite services are: (a) Provided in a community based alternative living arrangement outside the participant's home; and (b) Where applicable, delivered in accordance with COMAR 14.31.05 — 14.31.07. #### Regulation .07 Specific Conditions for PRTF Waiver Service Providers — Caregiver Peer-to-Peer Support and Youth Peer-to-Peer Support. *COMAR 10.21.10.07* A. A family support organization may provide PRTF waiver services of caregiver peer-to-peer support, youth peer-to-peer support, or family and youth training. To be eligible to provide PRTF waiver services as a family support organization, the organization shall: (1) Be a private, nonprofit entity designated under §501(c)(3) of the Internal Revenue Service Code, and submit copies of the certificate of incorporation and Internal Revenue Service designation; (2) Have a board of directors comprised of more than 50 percent caregivers with a primary daily responsibility for raising a child or youth up to 26 years old with emotional, behavioral, or mental health challenges; (3) Submit a list of board members with identification of those who are caregivers meeting the criteria in §A(2) of this regulation; (4) Establish hiring practices that give preference to: (a) Current or previous caregivers of a child or youth with emotional, behavioral, or mental health challenges; (b) Youth who are 18 through 26 years old, who have or had emotional or behavioral health challenges, or both; or (c) Both §A(4)(a) and (b) of this regulation; (5) Submit a copy of the organization's personnel policy that sets forth the preferred employment criteria stated in §A(4) of this regulation; (6) Employ a staff that is comprised of at least 75 percent individuals who are: (a) Current or previous caregivers of a child or youth with emotional, behavioral, or mental health challenges; or (b) Youth who are 18 through 26 years old with emotional, behavioral, or mental health challenges; (7) Submit a list of staff and positions held with identification of those who fit the experienced caregiver and youth criteria stated in §A(6) of this regulation; and (8) Submit a certificate of eligibility that includes: (a) Attestation of compliance with §A(1) — (6) of this regulation; and (b) The organization's mission statement that establishes the purpose of the organization as providing support and education to youth with emotional, behavioral, or mental health challenges and their caregivers. B. Caregiver Peer-to-Peer Support Provider. To provide the services set forth COMAR 10.09.79.06B, the provider shall: (1) Be employed by a family support organization; (2) Be 21 years old or older; (3) Receive supervision from an individual who is 21 years old or older, and has at least 3 years of experience providing peer-to-peer support; (4) Have current or prior experience as a caregiver of a child with SED or a young adult with SMI; and (5) Receive training and certification as approved by MHA. C. Youth Peer-to-Peer Support Provider. To provide services set forth in COMAR 10.09.79.06B, a provider shall: (1) Be 18 years old or older but not older than 26 years old; (2) Be employed by a family support organization; (3) Have experience with State or local services and systems as a consumer who has had emotional, behavioral, or mental health challenges; (4) Be supervised by an individual who is 21 years old or older, and has at least 3 years of experience providing peer-to-peer support or working with youth, or both; and (5) Receive training and certification as approved by MHA. #### Regulation .08 Specific Conditions for PRTF Waiver Service Providers — Family and Youth Training. *COMAR 10.21.10.08* A. Family and Youth Training Providers. To provide services set forth COMAR 10.09.79.06B, a provider shall be: (1) An approved waiver provider agency, including but not limited to, a family support organization; or (2) An approved individual waiver service provider. B. Qualifications to Provide Family and Youth Training Services. (1) All family and youth training providers shall: (a) Receive training and certification as approved by MHA; and (b) Have been a co-trainer with an experienced lead trainer. (2) Youth training providers shall: (a) Be 18 years old or older but not older than 26 years old; and (b) Have experience with State or local services and systems as a consumer who has or had emotional, behavioral or mental health challenges. (3) Family training providers shall: (a) Be 21 years old or older; and (b) Have current or prior experience as a caregiver of a child with SED or a young adult with SMI. #### Regulation .09 Specific Conditions for PRTF Waiver Service Providers — Expressive and Experiential Behavioral Services. *COMAR 10.21.10.09* A. Expressive and experiential behavioral services are: (1) Art behavioral services; (2) Dance/movement behavioral services; (3) Equine-assisted behavioral services; (4) Horticultural behavioral services; (5) Music behavioral services; and (6) Psychodrama/drama behavioral services. B. Qualification to Provide Expressive and Experiential Behavioral Services. (1) To provide a particular service set forth under COMAR 10.09.79.06B, an individual shall have: (a) A bachelor's or master's degree from an accredited college or university; and (b) Current registration in the applicable association as outlined in §B(2) of this regulation. (2) Association Registration. (a) Art Behavioral Services. To provide art behavioral services, an individual shall be currently registered as a registered art therapist by: (i) The Art Therapy Credentials Board in the American Art Therapy Association; or (ii) A comparable association with equivalent requirements. (b) For Dance Behavioral Services. To provide dance behavioral services, an individual shall be currently registered as a dance therapist registered, or an academy of dance therapists registered in: (i) The American Dance Therapy Association; or (ii) A comparable association with equivalent requirements. (c) For Equine-Assisted Behavioral Services. To provide equine-assisted behavioral services, an individual shall be currently certified by: (i) The Equine Assisted Growth and Learning Association (EAGALA) to provide services under the EAGALA model; (ii) The North American Handicapped Riding Association (NAHRA); or (iii) A comparable association with certification requirements at least equivalent to EAGALA or NAHRA. (d) For Horticultural Behavioral Services. To provide horticultural behavioral services, an individual shall be currently registered as a horticultural therapist registered in: (i) The American Horticultural Therapy Association; or (ii) A comparable association with equivalent requirements. (e) For Music Behavioral Services. To provide music behavioral services, an individual shall be currently registered as a music therapist-board certified by the Board for Music Therapists, Inc: (i) In the American Association for Music Therapy, Inc.; or (ii) A comparable association with equivalent requirements. (f) For Psychodrama/Drama Behavioral Services. To provide psychodrama/drama behavioral services, an individual shall be currently registered as a registered drama therapist or a board certified trainer in: (i) The National Association for Drama Therapy; or (ii) A comparable association with equivalent requirements. #### Regulation .10 Specific Conditions for PRTF Waiver Service Providers — Crisis and Stabilization Services. *COMAR 10.21.10.10* To provide the services set forth COMAR 10.09.79.06B, a provider shall: A. Be an agency; B. Have a current formal written agreement with a local core service agency to serve as a crisis response system; C. Have capacity to provide or arrange for services 24 hours a day, 7 days per week, including: (1) Face-to-face clinical care; (2) Psychiatric consultation; and (3) Person-to-person phone coverage; D. Employ clinical supervisors who: (1) Are licensed in good standing under Health Occupations Article, Annotated Code of Maryland, as a psychiatrist, social worker, registered nurse, or mental health professional; (2) Are permitted to provide supervision under their respective practice act; and (3) Have experience providing crisis response services; and E. Employ behavior care aides who: (1) Are 21 years old or older; (2) Have a bachelor's degree in a human services field; and (3) Receive initial and ongoing training on crisis and stabilization services. ### Chapter 11 — Purchase of Residential Therapeutic Care for Children **Authority:** Health-General Article, §10-902, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .03 adopted as an emergency provision effective October 13, 1992 (19:22 Md. R. 1980); adopted permanently effective March 29, 1993 (20:1 Md. R. 27) #### Regulation .01 Scope. *COMAR 10.21.11.01* This chapter outlines the requirements that a provider of residential therapeutic services to emotionally or behaviorally disordered children shall meet to be eligible to accept children placed by the Mental Hygiene Administration. #### Regulation .02 Definitions. *COMAR 10.21.11.02* A. In this chapter, the following terms have the meaning indicated. B. Terms Defined. (1) “Direct supervision” means that a provider staff member maintains continuous visual contact with the child. (2) “Family of origin” means the child's parent, guardian, or primary caretaker. (3) “Least restrictive setting” means the treatment program or facility in which needed services are delivered in the environment that least limits the child being served. (4) “Oversight” means that a provider staff member approves and is aware of the child's activities. (5) “Primary caretaker” means the adult individual who carries responsibility for the welfare of a child where the child resides. (6) “Secure setting” means a treatment program or facility that is locked to prevent a child from leaving without staff permission. #### Regulation .03 Provider Requirements. *COMAR 10.21.11.03* A provider of residential therapeutic services may not be eligible to accept children placed by the Maryland Department of Health unless the provider: A. Is licensed by the Department of: (1) Human Services, under the provisions of COMAR 07.02.23 or 07.02.13; (2) Juvenile Services, under the provisions of COMAR 16.06.01; or (3) Maryland Department of Health , under the provisions of COMAR 10.21.07; B. Has rates that are established by the Negotiated Rates Process of the Rates Management Unit, Social Services Administration of the Department of Human Services as authorized under the provisions of COMAR 21.14.01.04B(2); C. Provides the following core services: (1) Care and 24-hour supervision in a residential setting; (2) Direct provision of food and clothing; (3) Social work or case management services; (4) Recreational activities; (5) Access and linkage to appropriate community resources, including but not limited to: (a) Medical care; (b) Dental care; (c) Mental health treatment; (d) Education; and (e) Social services; and (6) Crisis intervention planning; D. Provides the additional services that, based on a documented clinical assessment, are required by the child who is being referred, including but not limited to: (1) A location as close as possible to the child's family of origin; (2) The least restrictive setting appropriate to the child's needs; and (3) As appropriate to the child's needs, a level of supervision that provides: (a) Opportunity for off-site activities, with oversight by provider staff; or (b) For a placement that is authorized by the State Coordinating Council for Residential Placement of Handicapped Children or a local coordinating council, as authorized under Article 49D, §§13 — 19, Annotated Code of Maryland: (i) Structured, on-site activities, with direct supervision by provider staff, and 24-hour awake staff; or (ii) The level of supervision described in §D(3)(b)(i) of this regulation in a secure setting; and E. Is in compliance with all applicable laws and regulations, including but not limited to laws and regulations governing patient rights, as set forth in Health-General Article, §§10-701 — 10-707, Annotated Code of Maryland. ### Chapter 12 — Use of Quiet Room and Use of Restraint **Authority:** Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland **Administrative History:** Effective date: October 25, 1993 (20:21 Md. R. 1654) **Administrative History:** Regulation .01 amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation .02B amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation .03 amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation .05 amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation .06D amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation .08D amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation .09 amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation 10D amended effective February 14, 2026 (52:23 Md. R. 1139) **Administrative History:** Regulation .12D, F amended effective February 14, 2026 (52:23 Md. R. 1139) #### Regulation .01 Scope. *COMAR 10.21.12.01* These regulations govern the use of quiet rooms and restraint in all facilities as defined in Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland. These regulations are supplemental to any other applicable law and regulation. In the event of conflict between these regulations and any other regulations or laws, the more stringent apply. #### Regulation .02 Definitions. *COMAR 10.21.12.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Category I Restraint. (a) “Category I restraint” means a device identified by the facility which limits a patient's mobility to the extent that the patient would not be able to independently reposition himself or herself or would otherwise be rendered helpless in an emergency. (b) “Category I restraint” includes, but is not limited to, four-point restraints. (2) “Category II restraint” means any device which is not considered by the facility as a category I restraint and includes, but is not limited to, mittens and vests. (3) “Chief executive officer (CEO)” means the individual responsible for the overall management of a facility. (4) “Child” means an individual younger than 12 years old. (5) “Clinical director” means the psychiatrist in charge of the clinical care of all psychiatric patients in the facility. (6) “Emergency situation” means a situation in which a patient's behavior poses a serious and imminent danger to the physical safety of self or others. (7) “Facility” means any public or private hospital, clinic, or other institution that provides or purports to provide treatment or other services for a mental disorder, except an acute general hospital that does not have a separately identified inpatient psychiatric service. (8) “Full view” means the unobstructed view by the assigned staff of a restrained patient. (9) “Patient” means an individual receiving services for a mental disorder in a facility and includes any student receiving care and treatment in that facility. (10) “Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland. (11) “Protective device” means any adaptive or assistive device or devices which restrict the movement of the whole or a portion of a patient's body for the purpose of preventing unintentional harm to self or others or which are used for promoting or maintaining normative body functions. (12) Prone Restraint. (a) “Prone restraint” means restricting the free movement of all or a portion of a patient’s body through the use of physical force or mechanical devices while the patient is in a prone position. (b) “Prone restraint” does not mean a technique for transitioning a patient to a restraint position that involves momentarily placing the individual face down. (13) “Quiet room” means an unlocked room that patients are not physically prevented from leaving, which is designated for patients' voluntary use to allow them time out of the company of other patients. (14) “Registered nurse” means an individual who is licensed to practice registered nursing under Health Occupations Article, Title 8, Annotated Code of Maryland. (15) Restraint. (a) “Restraint” means: (i) Any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move their arms, legs, body, or head freely; or (ii) A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition. (b) “Restraint” does not include a helmet when used as a sole form of restraint or a protective device. (16) “Seclusion” means the involuntary confinement of a patient under the direction of a physician or registered nurse alone in a room which a patient is physically prevented from leaving. (17) “Trauma-informed care” means mental health treatment that includes: (a) An appreciation for the high prevalence of trauma experienced by individuals receiving mental health services; (b) An understanding of the neurological, biological, psychological, and social effects of trauma and violence, including sexual abuse and exploitation, on an individual; and (c) An understanding of the environment, practices, and treatments that may need to be modified to address trauma issues. (18) “Treatment team” means the patient's treatment team as defined in COMAR 10.21.03.02C. #### Regulation .03 Use of Restraint. *COMAR 10.21.12.03* A. Staff authorized under the provisions of Regulation .05B of this chapter may use a restraint: (1) Only during an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury; (2) If ordered by a physician in writing; or (3) If at the direction of a registered nurse, if a physician's order is obtained within 2 hours of the action. B. Staff may not use a restraint: (1) As a mode or course of treatment; (2) As punishment, coercion, discipline, or retaliation; (3) For the convenience of staff; (4) To prevent damage or destruction to property; or (5) To prevent serious disruption of the therapeutic environment. C. Staff shall use a restraint: (1) In a humane, safe, and effective manner; (2) Without intent to harm or create undue discomfort to the patient; and and (3) For the shortest possible length of time, regardless of the length of time in the physician's order. D. Staff authorized under the provisions of Regulation .05B of this chapter may order the use of a restraint only if the physician, following a clinical evaluation of the patient, determines that: (1) The patient's behavior poses an emergency situation; and (2) Less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others. E. The approaches referred to in §D(2) of this regulation may include, but are not limited to: (1) Clinical interventions; (2) Quiet room; (3) Medication or medications; (4) Deescalation techniques; (5) Trauma-informed care interventions; (6) Calling the hospital's response team for assistance; and (7) Consulting the patient's care plan for personalized strategies. #### Regulation .04 Protective Device Use. *COMAR 10.21.12.04* A. When the definition of a restraint or a protective device is in dispute, in each case under discussion, the clinical director or the clinical director's physician designee shall clarify and document in the patient's medical record the device's correct purpose. B. The patient's treatment team shall document in the treatment plan the team's rationale for use of a protective device. #### Regulation .05 Procedures in the Use of Restraint. *COMAR 10.21.12.05* A. A facility shall: (1) Have a written policy specifying the method used to ensure that a patient whose primary language or method of communication is nonverbal is able to effectively communicate distress during a physical restraint or hold; and (2) Ensure that all staff at the facility who are authorized to participate in a physical restraint or hold of a patient are trained in the method specified in the written policy in accordance with §A(1) of this regulation. B. A physician who is responsible either for the care of the patient or for assessment of the appropriateness of a restraint or, when the appropriate physician is not readily available to assess the patient, a registered nurse shall conduct a clinical evaluation of the patient to determine whether an emergency situation is present. C. Before using restraint, the physician or registered nurse shall assess whether less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others. D. When a physician, as identified in §B of this regulation, is immediately available, the physician shall be responsible for determining a patient's need for a restraint and make the decision whether to restrain. E. Authorization in the Absence of a Physician. (1) When a physician, as identified in §B of this regulation, is not immediately available, a registered nurse shall determine a patient's need for restraint and may initiate and direct the use of restraint. (2) Within 2 hours of the implementation of the restraint, a physician shall give a written or verbal order for any restraint initiated by a registered nurse and, at that time, shall make the clinical determination to continue or to discontinue the restraint. #### Regulation .06 Placement of Patient in Restraint. *COMAR 10.21.12.06* A. When possible, staff shall advise a patient, in a nonthreatening manner, that continuation of a specific behavior may result in the use of restraint. B. When a physician or registered nurse determines that the use of a restraint is appropriate, staff involved shall make a reasonable effort to verbally persuade the patient to be cooperative with the restraint. C. Staff shall apply a restraint only in accordance with the facility's policy and procedure manual. D. For the patient's safety and the safety of others: (1) Staff shall place the patient in the restraint in as dignified a manner as the situation permits, using the least amount of physical force necessary; (2) As necessary, additional staff shall participate in the placement of a patient in restraint; (3) The patient shall be free from subject prone restraint; and (4) The patient shall be free from a restraint that: (a) Applies pressure to the patient’s back; (b) Obstructs the airway of the patient or impairs the patient’s ability to breathe; (c) Obstructs a staff member’s view of the patient’s face; or (d) Restricts the patent’s ability to communicate distress. E. Unless a physician or registered nurse determines that it is unsafe to do so, staff shall permit the patient to wear all or a portion of the patient's own clothes or another form of attire. F. Staff shall search the patient for potentially harmful objects. G. If staff determine a need for objects to be removed pursuant to §F of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects. H. Unless contraindicated for safety reasons, staff shall permit the patient to wear eyeglasses, hearing aids, dentures, or prosthetic devices. I. When placing a patient in a restraint, staff shall inspect each restraining device and ensure that each restraining device is safely and securely applied. J. As necessary, staff shall ensure that each restraint is padded to provide appropriate protection for the patient. #### Regulation .07 Limitations and Placement of Children in Restraint. *COMAR 10.21.12.07* In addition to the requirements outlined in this chapter, when: A. Restraining a child, staff may not use four-point restraints; and B. Applying or repositioning a restraint, staff shall avoid the application of force on long bone joints. #### Regulation .08 Clinical Interventions During Restraint. *COMAR 10.21.12.08* A. Regardless of the physical setting in which the patient is placed, at a minimum, one staff member shall be assigned continuously while the patient is in a category I restraint. B. While the patient is restrained, in order to provide appropriate clinical care, at a minimum, staff clinically trained to do so shall: (1) Keep the patient in full view at all times; (2) Protect the patient from harm by others; (3) Closely observe the patient at least every 15 minutes, and document each observation by the observer; (4) Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, at least hourly, make and document personal contact with the patient for the purpose of: (a) Determining if the patient has any special needs which need attention; (b) Checking circulation of the extremities restrained; (c) Adjusting the restraint; and (d) Realigning the body or massaging the extremities restrained, or both; (5) Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, offer or provide the following: (a) Full range of motion, every 2 hours; (b) Toilet facilities, at least every 2 hours; (c) Bathing and oral hygiene, at least once during a 24-hour period; (d) Meals, at the regularly scheduled hours and under the supervision of nursing personnel; and (e) Fluids, at least every 2 hours; and (6) As clinically indicated, record temperature, pulse, blood pressure, and respirations. C. At least once every 2 hours, a physician or registered nurse shall assess the appropriateness of continuing the restraint and document the factors supporting the assessment in the patient's medical record. D. When the patient's behavior no longer places the patient or others in serious threat of violence or injury, the patient shall be released from restraint. #### Regulation .09 Limitations on Restraint and Continuous Restraint. *COMAR 10.21.12.09* A. Staff may not initiate “standing” or “as needed” orders for restraint. B. Each order for restraint, used for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, may only be renewed in accordance with the following limits not to exceed 24 hours total: (1) Four hours for adults 18 years of age or older; (2) Two hours for children and adolescents 9 to 17 years of age; or (3) One hour for children under 9 years of age. C. After 24 hours, before writing a new order for the use of restraint for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, a physician must: (1) See, assess, and conduct a face-to-face evaluation of the patient to determine whether continuous restraint is appropriate; (2) Document in the patient's medical record the observed behavior that confirms that the patient, if released from restraint, would continue to present a danger to self or others; (3) Follow all requirements outlined in this chapter, including but not limited to §B of this regulation; and (4) Obtain the authorization of the clinical director or the clinical director's physician designee, neither of whom may be the treating physician. D. Upon a request from a patient's treating physician, prior to authorizing continued restraint in accordance with §C(4) of this regulation, the clinical director or the clinical director's designee shall perform a face-to-face evaluation of the patient who is restrained. E. Following the initial 24 hours of restraint authorized under §C of this regulation, additional periods of restraint, not to exceed 24 hours each, may be authorized only if the restraint is provided in accordance with §§B—D of this regulation. F. Treatment Team Involvement. (1) Minimally, at regularly scheduled meetings, the patient's treatment team shall examine the use of restraint for that patient. (2) Within 5 working days from the initiation of continuous restraint, regardless of whether the patient remains in restraint, the treatment team shall: (a) When applicable, review the appropriateness of the continued use of restraint; (b) Establish and implement a plan to eliminate the need for further restraint; and (c) Identify a team member who shall explain to the patient the potential risks and benefits of continuous restraint. #### Regulation .10 Documentation. *COMAR 10.21.12.10* A. Restraint Orders. A physician shall: (1) To initiate the use of restraint: (a) Enter an order in the patient's medical record; or (b) Authorize an order to be written by a registered nurse on the physician's order sheet in the patient's medical record: (i) Indicating that physician's verbal order for restraint; or (ii) Directing the release of the patient and the rationale for that release; (2) Countersign all verbal orders within 24 hours of the order's being written; and (3) Include in the order for restraint: (a) The date and time that the order was written; (b) The specific type of restraint to be used; (c) The maximum duration of restraint from the time that the restraint was initiated; (d) The specific rationale for restraint; (e) Special precautions, if any, to safeguard the patient; (f) The physician's signature; and (g) In the case of a verbal order, the names of both the ordering physician and the registered nurse who received the verbal order. B. As soon as possible after implementation, but not later than the close of the shift, staff shall: (1) Document the implementation of restraint in the patient's medical record; and (2) Include in the documentation the following information: (a) A description of the specific behavior leading to restraint; (b) Whether and which less restrictive techniques were used, and, if not, why not; (c) Whether a formal call for facility staff response was required, the names of staff assisting in the restraint, and the circumstances while restraining the patient; (d) The readily observable physical condition of the patient; (e) The date and time of the restraint and signature of the recorder; (f) Whether the patient was permitted to wear the patient's own clothes or other attire and, if not, the reason or reasons for this; and (g) A description of any physical injury to either the patient or others resulting from placement of the patient in restraint. C. While a patient is restrained, staff shall document the clinical interventions employed, including those listed in Regulation .08 of this chapter. D. Release from Restraint. (1) When a physician clinically determines that a patient is to be released from restraint, the physician shall: (a) Order the release and write, sign, and date a note indicating the rationale for the release; and (b) If verbally ordering the release, write, sign, and date the note not later than 24 hours after a verbal order to release. (2) When a registered nurse clinically determines that the release of the patient before the maximum period specified on a physician's order is appropriate, the registered nurse shall: (a) Direct termination of the restraint; and (b) Document, sign, and date the rationale for the termination of restraint in the patient's medical record. #### Regulation .11 Use of Quiet Room. *COMAR 10.21.12.11* A. Patient Request. (1) A patient may request the use of a quiet room and, unless clinically contraindicated, may be granted use of a quiet room. (2) Unless staff terminates use of the quiet room for clinical reasons, the patient may terminate self-initiated use of the quiet room at any time. B. Staff Request. (1) When staff, permitted by the facility to initiate and terminate use of a quiet room, determine that the use of the quiet room is clinically indicated, staff may request that a patient voluntarily enter into the quiet room. (2) Staff may not coerce a patient into entering the quiet room. (3) When the patient enters the quiet room, staff shall discuss with the patient: (a) The recommended length of stay in the quiet room; (b) The behaviors expected of the patient before and upon return to the milieu; and (c) The primary interventions to be initiated if the use of the quiet room is terminated by the patient before the time recommended by staff or is determined to be ineffective. C. Staff shall determine the need for removal of any harmful objects in the room or from the patient. D. If staff determine a need for objects to be removed pursuant to §C of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects. E. While a quiet room is in use, the staff shall assure that the quiet room door is not locked or in a position that prevents a patient from exiting the room voluntarily. F. Observation and Documentation. Staff shall: (1) Be assigned to monitor the patient and the safety of the environment while a patient is in the quiet room; (2) When the quiet room is used as a clinical intervention, observe the patient at least once every 30 minutes and document the observation in the patient's medical record; and (3) At least every 2 hours, evaluate the effectiveness of the outcome and document the clinical rationale for continued use of the quiet room. G. A physician shall review the use of the quiet room after 6 hours and, if use of the quiet room is continued, at least every 24 hours after that. H. Use of a quiet room may be terminated at any time: (1) Upon the decision of the patient; or (2) As clinically determined by staff. #### Regulation .12 Quality Assurance. *COMAR 10.21.12.12* A. The clinical director or the clinical director's designee shall review daily all uses of restraint and investigate unusual or possibly unwarranted patterns of use. B. The physician involved in the restraint may not function in the capacity outlined in §A of this regulation. C. A facility shall identify a committee to review periodically, but not less than quarterly, the use of restraint to assure that the standards maintained by the facility are, at a minimum, consistent with this chapter. D. Staff who implement orders for restraint: (1) Shall have documented annual training in the proper use of physical restraint and hold including training for special populations which include, but are not limited to, children and the elderly; (2) Shall have documented annual training in trauma-informed care and demonstrate competency in providing trauma-informed care services; and (3) May not implement orders for restraint until trained by the facility to do so unless, in an emergency situation, the safety of the patient or others is threatened. E. The facility's chief executive officer or the chief executive officer's designee is responsible for assuring that the restraint devices used in that facility are maintained in accordance with acceptable standards for hygiene and safety. F. If seclusion is used in conjunction with restraint, staff shall also comply with COMAR 10.21.13. #### Regulation .13 Procedures Pertaining to Complaints. *COMAR 10.21.12.13* Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism. #### Regulation .14 Variance with Standards. *COMAR 10.21.12.14* A. Excluding the prohibition described in §B of this regulation, staff may not vary from the standards identified in this chapter unless the variation is for an extreme crisis. B. There may not be any variance with standards established in this regulation and in Regulations .03 and .04, .06B—G and I—J, .07, .09A, .11, .12A and D—F, .13, and .14 of this chapter. C. Staff shall document, on the facility's variance report, a variance with standards permitted under this chapter. D. The CEO shall rule on and document each variance permitted in §A of this regulation to determine whether the variance was: (1) An extreme crisis; (2) A deviation from the facility's procedure; or (3) A problem in the facility's policy which is correctable by administrative action. E. The CEO shall assure that the facility's quality assurance process incorporates a monthly review of any variance permitted in §A of this regulation. ### Chapter 13 — Use of Quiet Room and Use of Seclusion **Authority:** Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland **Administrative History:** Effective date: October 25, 1993 (20:21 Md. R. 1654) **Administrative History:** Regulation .01 amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .02B amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .03 amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .04 amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .05C amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .05I adopted effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .06C amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .07 amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .08D amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .01D, F amended effective November 24, 2025 (52:23 Md. R. 1139) **Administrative History:** Regulation .12B amended effective November 24, 2025 (52:23 Md. R. 1139) #### Regulation .01 Scope. *COMAR 10.21.13.01* These regulations govern the use of quiet rooms and seclusion in all facilities as defined in Health-General Article, §§10-101(g) and 10-701, Annotated Code of Maryland. These regulations are supplemental to any other applicable law and regulation. In the event of conflict between these regulations and any other regulations or laws, the more stringent apply. #### Regulation .02 Definitions. *COMAR 10.21.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Chief executive officer (CEO)” means the individual responsible for the overall management of a facility. (2) “Clinical director” means the psychiatrist in charge of the clinical care of all psychiatric patients in that facility. (3) “Emergency situation” means any situation in which a patient's behavior poses a serious and imminent danger to the physical safety of self or others. (4) “Facility” means any public or private hospital, clinic, or other institution that provides or purports to provide treatment or other services for a mental disorder, except an acute general hospital that does not have a separately identified inpatient psychiatric service. (5) “Patient” means an individual receiving services for a mental disorder in a facility and includes any student receiving care and treatment in that facility. (6) “Physician” means an individual who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland. (7) Prone Restraint. (a) “Prone restraint” means restricting the free movement of all or a portion of a patient’s body through the use of physical force or mechanical devices while the patient is in a prone position. (b) “Prone restraint” does not mean a technique for transitioning a patient to a restraint position that involves momentarily placing the individual face down. (8) “Quiet room” means an unlocked room that patients are not physically prevented from leaving, which is designated for patients' voluntary use to allow them time out of the company of other patients. (9) “Registered nurse” means an individual who is licensed to practice registered nursing under Health Occupations Article, Title 8, Annotated Code of Maryland. (10) “Seclusion” means the involuntary confinement of a patient under the direction of a physician or registered nurse alone in a room which a patient is physically prevented from leaving. (11) “Trauma-informed care” means mental health treatment that includes: (a) An appreciation for the high prevalence of trauma experienced by individuals receiving mental health services; (b) An understanding of the neurological, biological, psychological, and social effects of trauma and violence, including sexual abuse and exploitation, on an individual; and (12) “Treatment team” means the patient's mental health professional treatment team as defined in COMAR 10.21.03.02C. #### Regulation .03 Use of Seclusion. *COMAR 10.21.13.03* A. Staff authorized under the provisions of Regulation .04C of this chapter may use seclusion: (1) Only during an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury; and (2) If ordered by a physician in writing; or (3) If at the direction of a registered nurse if a physician's order is obtained within 2 hours of the action. B. Staff may not use seclusion: (1) As a mode or course of treatment; (2) As punishment, coercion, discipline, or retaliation; (3) For the convenience of staff; (4) To prevent damage or destruction to property; or (5) To prevent serious disruption of the therapeutic environment. C. Staff shall conduct seclusion: (1) In a humane, safe, and effective manner; (2) Without intent to harm or create undue discomfort to the patient; and (3) For the shortest possible length of time, regardless of the length of time in the physician's order. D. Staff authorized under the provisions of Regulation .04C of this chapter may order the use of seclusion only if that staff person, following a clinical evaluation of the patient, determines that: (1) The patient's behavior poses an emergency situation; and (2) Less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others. E. The approaches referred to in §D(2) of this regulation may include, but are not limited to: (1) Clinical interventions; (2) Quiet room; (3) Medication or medications; (4) Deescalation techniques; (5) Trauma-informed care interventions; (6) Calling the hospital's response team for assistance; and (7) Consulting the patient's care plan for personalized strategies. #### Regulation .04 Procedures in the Use of Seclusion. *COMAR 10.21.13.04* A. A facility shall have a written policy specifying the method used to ensure that a patient whose primary language or method of communication is nonverbal is able to effectively communicate distress during a seclusion. B. A facility shall ensure that all staff at the facility who are authorized to participate in a seclusion of patients are trained in the method specified in the written policy in accordance with §A(1) of this regulation. C. A physician who is responsible either for the care of the patient or for assessment of the appropriateness of seclusion or, when the appropriate physician is not readily available to assess the patient, a registered nurse shall conduct a clinical evaluation of the patient to determine whether an emergency situation is present. D. Before instituting seclusion, the physician or registered nurse shall assess whether less restrictive or alternative approaches have been determined to be ineffective to ensure the safety of the patient, staff, or others. E. When a physician, as identified in §C of this regulation, is immediately available, the physician shall be responsible for determining a patient's need for seclusion and make the decision whether to seclude. F. Authorization in the Absence of a Physician. (1) When a physician, as identified in §C of this regulation, is not immediately available, a registered nurse shall determine a patient's need for seclusion and may initiate and direct the use of seclusion. (2) Within 2 hours of the implementation of the seclusion, a physician shall give a written or verbal order for any seclusion initiated by a registered nurse and, at that time, shall make the clinical determination to continue or discontinue the seclusion. #### Regulation .05 Placement of a Patient in a Seclusion Room. *COMAR 10.21.13.05* A. When possible, staff shall advise a patient, in a nonthreatening manner, that continuation of a specific behavior may result in the use of seclusion. B. When a physician or registered nurse determines that the use of seclusion is appropriate, staff involved shall make a reasonable effort to verbally persuade the patient to enter the seclusion room. C. For patient's safety and the safety of others: (1) Staff shall place the patient in the seclusion room in as dignified a manner as the situation permits, using the least amount of physical force necessary; (2) As necessary, additional staff shall participate in the placement of a patient in seclusion; (3) The patient shall be free from prone restraint; and (4) The patient shall be free from restraint that: (a) Applies pressure to the individual’s back; (b) Obstructs the airway of the individual or impairs the individual’s ability to breathe; (c) Obstructs a staff member’s view of the individual’s face; or (d) Restricts the individual’s ability to communicate distress. D. Unless a physician or registered nurse determines that it is unsafe to do so, staff shall permit the patient to wear all or a portion of the patient's own clothes or another form of attire. E. Staff shall search the patient for potentially harmful objects. F. If staff determines a need for objects to be removed pursuant to §E of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects. G. Unless contraindicated for safety reasons, staff shall permit the patient to wear eyeglasses, hearing aids, dentures, or prosthetic devices. H. Staff shall inspect the seclusion room for potentially dangerous conditions and, as appropriate, shall fully secure the room. I. If a patient is confined to a room in a manner that meets the definition of seclusion in accordance with Regulation .02B of this chapter, the patient is considered to be subject to seclusion, regardless of whether the room used is typically used as a seclusion room. #### Regulation .06 Clinical Interventions During Seclusion. *COMAR 10.21.13.06* A. While the patient is secluded, in order to provide appropriate clinical care, at a minimum, clinically trained staff shall: (1) Observe the patient at least every 15 minutes, and document each observation by the observer; (2) Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, at least hourly, make and document personal contact with the patient for the purpose of determining if the patient has any special needs which need attention; (3) Unless contraindicated by circumstances as assessed and documented by a physician or registered nurse, offer or provide the following: (a) Toilet facilities, at least every 2 hours; (b) Bathing and oral hygiene, at least once during a 24-hour period; (c) Meals, at the regularly scheduled hours and under the supervision of nursing personnel; and (d) Fluids, at least every 2 hours; and (4) As clinically indicated, record temperature, pulse, blood pressure, and respirations. B. At least once every 2 hours, a physician or registered nurse shall assess the appropriateness of continuing the seclusion and document the factors supporting the assessment in the patient's medical record. C. When the patient's behavior no longer places the patient or others in serious threat of violence or injury, the patient shall be released from seclusion. #### Regulation .07 Limitations on Seclusion and Continuous Seclusion. *COMAR 10.21.13.07* A. Staff may not initiate “standing” or “as needed” orders for seclusion. B. Each order for seclusion, used for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, may only be renewed in accordance with the following limits not to exceed 24 hours total: (1) Four hours for adults 18 years of age or older; (2) Two hours for children and adolescents 9 to 17 years of age; or (3) One hour for children under 9 years of age. C. After 24 hours, before writing a new order for the use of seclusion for the management of an emergency in which the behavior of the patient places the patient or others in serious threat of violence or injury, a physician must: (1) See, assess, and conduct a face-to-face evaluation of the patient to determine whether continuous seclusion is appropriate; and (2) Document in the patient's medical record the observed behavior that confirms that the patient, if released from seclusion, would continue to present a danger to self or others; (3) Follow all requirements outlined in this chapter, including but not limited to §B of this regulation; and (4) Obtain the authorization of the clinical director or the clinical director's physician designee, neither of whom may be the treating physician. D. Upon a request from a patient's treating physician, prior to authorizing continued seclusion, in accordance with §C(4) of this regulation, the clinical director or the clinical director's designee shall perform a face-to-face evaluation of the patient who is secluded. E. Following the initial 24 hours of seclusion authorized under §C of this regulation, additional periods of restraint, not to exceed 24 hours each, may be authorized only if the seclusion is provided in accordance with §§B—D of this regulation. F. Treatment Team Involvement. (1) Minimally, at regularly scheduled meetings, the patient's treatment team shall review the use of seclusion for that patient. (2) Within 5 working days from the initiation of continuous seclusion, regardless of whether the patient remains in seclusion, the treatment team shall: (a) When applicable, review the appropriateness of the continued use of seclusion; (b) Establish and implement a plan to eliminate the need for further seclusion; and (c) Identify a team member who shall explain to the patient the potential risks and benefits of continuous seclusion. #### Regulation .08 Documentation. *COMAR 10.21.13.08* A. Seclusion Orders. A physician shall: (1) To initiate the use of seclusion: (a) Enter an order in the patient's medical record; or (b) Authorize an order to be written by a registered nurse on the physician's order sheet in the patient's medical record: (i) Indicating that physician's verbal order for seclusion; or (ii) Directing the release of the patient and the rationale for that release; (2) Countersign all verbal orders within 24 hours of the order's being written; and (3) Include in the order for seclusion: (a) The date and time that the order was written; (b) The maximum duration of seclusion from the time that the seclusion was initiated; (c) The specific rationale for seclusion; (d) Special precautions, if any, to safeguard the patient; (e) The physician's signature; and (f) In the case of a verbal order, the names of both the ordering physician and the registered nurse who received the verbal order. B. As soon as possible after implementation, but not later than the close of the shift, staff shall: (1) Document the implementation of seclusion in the patient's medical record; and (2) Include in the documentation the following information: (a) A description of the specific behavior leading to seclusion; (b) Whether and which less restrictive techniques were used, and, if not, why not; (c) Whether a formal call for facility staff response was required, the names of staff assisting in the seclusion, and the circumstances while secluding the patient; (d) The readily observable physical condition of the patient; (e) The date and time of the seclusion and signature of the recorder; (f) Whether the patient was permitted to wear the patient's own clothes or other attire and, if not, the reason or reasons for this; and (g) A description of any physical injury to either the patient or others resulting from placement of the patient in seclusion. C. While a patient is in seclusion, staff shall document in the patient's medical record the clinical interventions employed, including those listed in Regulation .06 of this chapter. D. Release from Seclusion. (1) When a physician clinically determines that a patient is to be released from seclusion, the physician shall: (a) Direct termination of the seclusion with or without a physician's order; and (b) If verbally ordering the release, write, sign, and date the note not later than 24 hours after a verbal order to release. (2) When a registered nurse clinically determines that the release of the patient before the maximum period specified on a physician's order is appropriate, the registered nurse shall: (a) Order termination of the seclusion with or without a physician's order, unless the physician's order specifically requires physician concurrence with the termination; and (b) Document, sign, and date the rationale for the termination of seclusion in the patient's record. #### Regulation .09 Use of Quiet Room. *COMAR 10.21.13.09* A. Patient Request. (1) A patient may request the use of a quiet room and, unless clinically contraindicated, may be granted use of a quiet room. (2) Unless staff terminates use of the quiet room for clinical reasons, the patient may terminate self-initiated use of the quiet room at any time. B. Staff Request. (1) When staff, permitted by the facility to initiate and terminate use of a quiet room, determine that the use of the quiet room is clinically indicated, staff may request that a patient voluntarily enter into the quiet room. (2) Staff may not coerce a patient into entering the quiet room. (3) When the patient enters the quiet room, staff shall discuss with the patient: (a) The recommended length of stay in the quiet room; (b) The behaviors expected of the patient before and upon return to the milieu; and (c) The primary interventions to be initiated if the use of the quiet room is terminated by the patient before the time recommended by staff or is determined to be ineffective. C. Staff shall determine the need for removal of any harmful objects in the room or from the patient. D. If staff determine a need for objects to be removed pursuant to §C of this regulation, staff shall ask the patient, in a nonthreatening manner, to surrender the objects. E. While a quiet room is in use, the staff shall assure that the quiet room door is not locked or in a position that prevents a patient from exiting the room voluntarily. F. Observation and Documentation. Staff shall: (1) Be assigned to monitor the patient and the safety of the environment while a patient is in the quiet room; (2) When the quiet room is used as a clinical intervention, observe the patient at least once every 30 minutes and document the observation in the patient's medical record; and (3) At least every 2 hours, evaluate the effectiveness of the outcome and document the clinical rationale for continued use of the quiet room. G. A physician shall review the use of the quiet room after 6 hours and, if use of the quiet room is continued, at least every 24 hours after that. H. Use of a quiet room may be terminated at any time: (1) Upon the decision of the patient; or (2) As clinically determined by staff. #### Regulation .10 Quality Assurance. *COMAR 10.21.13.10* A. The clinical director or the clinical director's designee shall review daily all uses of seclusion and investigate unusual or possibly unwarranted patterns of use. B. The physician involved in the seclusion may not function in the capacity outlined in §A of this regulation. C. A facility shall identify a committee to review periodically, but not less than quarterly, the use of seclusion to assure that the standards maintained by the facility are, at a minimum, consistent with this chapter. D. Staff who implement orders for seclusion: (1) Shall have documented annual training in the proper use of seclusion including training for special populations which include, but are not limited to, children and the elderly; (2) Shall have documented annual training in trauma-informed care and demonstrate competency in providing trauma-informed care services; (3) May not implement orders for seclusion until trained by the facility to do so unless, in an emergency situation, the safety of the patient or others is threatened. E. Standards for a Seclusion Room. (1) The CEO or the CEO's designee is responsible for assuring that the seclusion room or rooms in the facility are maintained in accordance with acceptable standards for hygiene and safety. (2) Staff shall ensure that each seclusion room: (a) Unless clinically contraindicated and the record reflects that assessment, has a mattress provided; (b) At the beginning of each shift, is inspected and maintained for proper temperature, ventilation, safety, lighting, sanitation, and freedom from dangerous conditions; and (c) Is fitted with a means of observation that affords staff a view of the entire room and permits clinical staff periodically to observe the patient. F. If restraint is used in conjunction with seclusion, staff shall also comply with COMAR 10.21.12. #### Regulation .11 Procedures Pertaining to Complaints. *COMAR 10.21.13.11* Complaints about the individual application of this chapter may be addressed through any patient grievance mechanism. #### Regulation .12 Variance with Standards. *COMAR 10.21.13.12* A. Excluding the prohibition described in §B of this regulation, staff may not vary from the standards identified in this chapter unless the variation is for an extreme crisis. B. There may not be any variance with standards established in: (1) This regulation; (2) Regulation .03 of this chapter; (3) Regulation .04 of this chapter; (4) Regulation .05B—E, G, and I of this chapter; (5) Regulation .07A of this chapter; (6) Regulation .09 of this chapter; (7) Regulation .10A, D, E(1), and F of this chapter; and (8) Regulation .11 of this chapter. C. Staff shall document, on the facility's variance report, a variance with standards permitted under this chapter. D. The CEO shall rule on and document each variance permitted in §A of this regulation to determine whether the variance was: (1) An extreme crisis; (2) A deviation from the facility's procedure; or (3) A problem in the facility's policy which is correctable by administrative action. E. The CEO shall assure that the facility's quality assurance process incorporates a monthly review of any variance permitted in §A of this regulation. ### Chapter 14 — Resident Grievance System **Authority:** Health-General Article, §7.5-201, 7.5-205(D), 10-701, Annotated Code of Maryland **Administrative History:** Effective date: March 28, 1994 (21:6 Md. R. 467) **Administrative History:** Regulation .01 amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .02B amended effective January 26, 1998 (25:2 Md. R. 76); October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .03C amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .04 amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .06H amended effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .10B, C amended effective October 23, 2017 (44:21 Md. R. 983) #### Regulation .01 Scope. *COMAR 10.21.14.01* These regulations govern the administrative process to be used to ensure that the rights of residents residing in the Behavioral Health Administration facilities are protected. Although the residents and the legal assistance providers ultimately shall decide whether to invoke the Resident Grievance System, it is the intent that the Resident Grievance System provide a fair, efficient, and complete mechanism for receiving, investigating, and resolving resident complaints, including rights issues, in a timely manner. #### Regulation .02 Definitions. *COMAR 10.21.14.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Central Review Committee” means the Maryland Department of Health (MDH) staff or their respective designees in the following positions: (a) The Director of the Behavioral Health Administration; (b) The clinical director of the Behavioral Health Administration; and (c) The Director of the Resident Grievance System. (2) “Chief executive officer (CEO)” means the individual appointed by the Director of the Behavioral Health Administration to act on the Director’s behalf in the overall management of a Behavioral Health Administration facility. (3) “Coe consent decree” means the legally binding consent decree in Coe v. Hughes ordered by the United States District Court for Maryland which sets forth the legal rights of Mental Hygiene Administration facility residents with respect to the provision of legal and other related services by the legal assistance provider and the rights advisor. (4) “Department (MDH)” means the Maryland Department of Health. (5) “Director of Resident Grievance System” means the individual designated by the Deputy Secretary of Public Health Services to supervise the rights advisors and to perform the duties required to implement the Resident Grievance System. (6) “Facility” means an inpatient or residential institution that is owned or directly operated by the Behavioral Health Administration. (7) “Grievance” means a written or oral statement, as authorized in Regulation .05B of this chapter, alleging that a: (a) Resident's rights have been unfairly limited or violated or are likely to be violated in the immediate future; (b) Resident has been abused, neglected, or mistreated; or (c) Facility has acted in an illegal or improper manner with respect to a resident or a group of residents. (8) “Grievant” means a resident on whose behalf a grievance is filed, whether initiated by the resident, an employee of a facility, a family member of the resident, or an interested person. (9) “Legal assistance provider (LAP)” means the lawyers and legally trained individuals who work under the lawyers' supervision who are responsible for providing legal services in accordance with the Coe consent decree. (10) “Resident” means an individual who resides in a Behavioral Health Administration inpatient or residential facility or who was released or discharged from the facility within the past 90 days. (11) “Resident Grievance System (RGS)” means the accessible administrative mechanism designed to protect a resident's rights through the investigation, processing, and resolution of grievances and implementation of the resolution. (12) “Residents' rights committee” means a committee composed of at least nine members who are representative of: (a) Facility staff; (b) Residents, former residents, and residents' family members; and (c) Advocacy groups. (13) “Rights advisor” means an individual assigned as a resident advocate to implement the RGS. (14) “Rights issue” means an alleged violation of a resident's rights guaranteed by federal and State constitutions, statutes, regulations, common law, or policies of the Maryland Department of Health and the facility. (15) “Unit director” means an individual who has administrative authority within an organizational component of a facility. (16) “Working day” means every day excluding Saturdays, Sundays, and holidays on which State offices are closed. #### Regulation .03 General Policies of the Resident Grievance System. *COMAR 10.21.14.03* A. When invoked, and when the process provides a fair, efficient, and complete remedy for allegations of rights violations, a grievant, when involved, the grievant's LAP, and the facility shall follow the four-stage administrative procedure outlined in this chapter. B. Through a timely process of systematic and orderly stages as outlined in this chapter, all those involved in the RGS process shall give grievances a fair consideration. C. To ensure that the rights of residents in the Behavioral Health Administration facilities are fully protected and that allegations of rights violations are investigated and resolved, the Director of the RGS shall provide an accessible internal system. D. The rights advisor shall investigate grievances: (1) Promptly, impartially, and with the least disruption to the grievant's treatment plan; and (2) Without abridging the right of a grievant to have the grievance process transpire within the required time frames or be completed within 65 working days. E. Except in accordance with the provisions outlined in Regulations .06—.10 of this chapter, and except to the extent necessary to conduct an investigation, report on the results of the investigation, and resolve the grievance, the individuals involved in the investigation of a grievance shall keep confidential the information gathered or disclosed during the course of the investigation. F. If a LAP is involved, the rights advisor shall provide to the LAP reports on the status of the grievances processed, the administrative decisions of the RGS at each stage, and the remaining RGS stages scheduled or to be scheduled. G. The Department may not subject an individual to discipline, harassment, or retribution for filing a grievance, pursuing a remedy for a grievance or, in cases when a grievance is substantiated, obtaining corrective action through the RGS. H. A resident who has concerns, including grievances, may request resolution from: (1) The treatment team; or (2) If the resident chooses not to involve the treatment team, the RGS. I. Except as provided in §J of this regulation, a grievant may terminate a grievance through the RGS at any time, either orally or in writing. If the termination is oral, the rights advisor shall document the oral termination of a grievance in the record of the grievance that is maintained by the rights advisor. J. If a grievant seeks to terminate a grievance that alleges abuse or serious harm or the potential for abuse or serious harm, the rights advisor shall notify the CEO and the Director of the RGS, either of whom may determine whether the investigation may continue. K. Within the time periods specified in Regulations .06—.09 of this chapter, the rights advisor shall file, investigate, and review a grievance, render a decision, and notify the grievant. L. In cases in which grievances alleging abuse have been substantiated, the facility shall take corrective action immediately. M. If time periods for stages lapse and extensions are denied, the rights advisor shall proceed with the next stage of the grievance. N. Those involved in the RGS process shall ensure that they complete the process within 65 working days. #### Regulation .04 Duties of the Rights Advisors and Director of the RGS. *COMAR 10.21.14.04* A. The rights advisor shall: (1) Investigate all complaints in a professionally appropriate manner; (2) Attempt to resolve grievances fairly and thoroughly; (3) Prepare written reports for each grievance investigated; (4) Maintain the RGS reports; (5) Attempt to identify residents who may benefit from services offered by the LAP and: (a) Refer the residents identified to the LAP; and (b) Advise the LAP of the referrals; (6) Investigate abuse allegations, even though the State police and the facility also may be conducting an investigation of the same allegations; (7) Monitor any corrective action used to resolve grievances, and: (a) Notify the CEO if corrective action has not been taken; and (b) If corrective action has not been taken by the CEO within a reasonable period of time, notify the RGS Director; (8) When a rights advisor discusses a grievance with a grievant, inform the grievant that, if the grievant requests, the rights advisor is available to attend and advocate for the grievant before the Behavioral Health Administration committees, boards, and tribunals; (9) Inform the grievant of the right to appeal a decision during any stage of the grievance process, and if a grievant wishes to appeal: (a) Upon request, file an appeal on behalf of the grievant; (b) Advise the grievant that the resident may be represented by a LAP following the completion of stage 2 of the grievance procedure; and (c) With the grievant's consent, attend and advocate in the best possible manner for the grievant on appeal, except in cases when, as a result of the rights advisor's professional judgment, the grievant's case is determined to be frivolous; and (10) In cases when, as a result of the rights advisor's professional judgment, the grievant's case is determined to be frivolous, forward the grievance to the Director of the RGS. B. The Director of the RGS shall: (1) If the rights advisor for a facility is not available for 2 or more consecutive working days, designate an alternate rights advisor; (2) Arrange for the provision of appropriate training to: (a) The rights advisors; and (b) Facility staff, regarding relevant legal documents, including Department policies and procedures, related to residents' rights; (3) If a rights advisor informs the Director of the RGS that the CEO has not taken corrective action within a reasonable period of time, notify the Director of the Behavioral Health Administration, who shall ensure that grievance resolution, at any level, is implemented promptly; (4) If a rights advisor informs the Director of the RGS that the rights advisor has determined that a grievant's grievance is frivolous, review the determination, and, following that review, if the Director of the RGS: (a) Agrees with the rights advisor and a LAP is involved, forward the grievance to the LAP, who may request continuation of the RGS process; or (b) Does not agree with the rights advisor, notify: (i) The rights advisor to proceed with the grievance; and (ii) The LAP of the action taken; and (5) Make appropriate arrangements to ensure that a rights advisor shall: (a) Be independent to discharge responsibilities; (b) As necessary to conduct an investigation, have the access to facility staff, the LAP, and others relevant to the investigation; and (c) Have access to a resident's medical records: (i) Excluding conditions outlined in Regulation .05C(2)(c) of this chapter, subject to the provisions in Health-General Article, §10-701(d), Annotated Code of Maryland, or any other applicable provisions of law; and (ii) Immediately, in cases of allegations of abuse or neglect of the resident. #### Regulation .05 Procedures for Filing a Grievance. *COMAR 10.21.14.05* A. A facility shall provide for a direct and effective means of communication between the residents and the rights advisor, including but not limited to communication by telephone and in person. B. The following may present a grievance to a rights advisor: (1) A resident; (2) An employee of a facility; (3) A resident's family member; (4) A LAP; or (5) An interested person. C. If the grievance is initiated orally, the rights advisor shall: (1) Assist in completing a grievance form and, if possible, obtain the grievant's signature; and (2) If a grievance is initiated on the resident's behalf: (a) Contact the resident to determine if the resident wants the matter to be investigated; (b) Counsel the resident about the resident's rights regarding the grievance procedure; and (c) If the resident elects to proceed with the grievance, obtain the resident's written consent to investigate or, if the resident does not sign, document the rationale for not obtaining the resident's signature. D. Pursuant to §E of this regulation, a resident about whom a grievance is initiated may elect not to file a grievance or may withdraw a grievance before disclosure of identity of the resident is made, if the resident notifies the rights advisor of the withdrawal or election not to file. E. If a resident elects not to file a grievance or if the grievant has requested that a grievance be withdrawn or is unable or unwilling to respond, the rights advisor shall proceed with the investigation if the: (1) Rights advisor believes that the: (a) Situation has resulted or may result in serious harm to the grievant or other residents; (b) Complaint appears to have substantial merit and requires further investigation; (c) Grievance highlights issues which may affect a substantial number of other residents; or (2) Director of the RGS grants approval to proceed. F. The rights advisor shall keep the identity of the grievant confidential except when: (1) Confidentiality interferes with investigation or resolution of the grievance; or (2) Good cause requires disclosure of the grievant's identity. G. If the rights advisor determines that disclosure of the identity of the grievant is necessary according to the provisions of §F of this regulation, the rights advisor shall: (1) Inform the grievant of the disclosure; and (2) Assure that disclosure be limited to that which is necessary to investigate, assess, and resolve the grievance. H. A facility employee shall report immediately to the CEO and the rights advisor all physical or sexual abuse as defined in Health-General Article, §10-705(a), Annotated Code of Maryland. I. A facility employee shall file a grievance on behalf of a resident when, in that employee's reasonable judgment, there exist instances of rights violations, mental, physical, or sexual abuse, neglect or mistreatment, or instances when the facility has acted in an illegal or improper manner with respect to a resident or a group of residents. J. If requested by a resident, a facility employee shall: (1) Notify the rights advisor immediately of the request; or (2) If the rights advisor is not immediately available: (a) Leave a written or a tape-recorded message concerning the request; and (b) Contact the Director of the RGS for issues which require an immediate response. K. Except for good cause, the rights advisor shall process grievances in the order received, if first priority is given to cases alleging: (1) Abuse; (2) Neglect; or (3) Mistreatment. L. If a grievance alleges abuse: (1) The rights advisor shall investigate; (2) The CEO of the facility shall refer the grievance to the Maryland State Police or the appropriate law enforcement agency for investigation; and (3) For residents up to 18 years old, the CEO shall refer the grievance to the local department of social services. M. In addition to the requirements outlined in §L of this regulation, the CEO may: (1) Conduct an investigation of the alleged abuse case; and (2) Refer the alleged abuse case to the treatment team. N. If grievances refer to the same incident: (1) The rights advisor may treat the grievances as one issue; and (2) For cases involving more than one grievant, the rights advisor shall send separate notices and copies of decisions and appeals of decisions to each grievant. O. If the rights advisor is the subject of the grievance, the rights advisor shall inform the grievant of the name, mailing address, and telephone number of the Director of the RGS who shall: (1) Appoint a substitute rights advisor for the purpose of that grievance; and (2) Notify the CEO of the substitute appointment. P. The LAP may conduct interviews with residents. When the LAP refers a case that results in a grievance or is asked by the grievant for representation, the LAP: (1) Shall inform the grievant that the LAP may not represent the grievant in the RGS process until stage 2 of the grievance procedure has been completed; (2) May represent a grievant pursuant to the requirements and limitations outlined in this chapter; and (3) Shall receive reports from the rights advisor while the investigation is in progress and at the conclusion of each stage. Q. For a grievance that is initiated after the effective date of this chapter, and upon request by the grievant, the rights advisor shall provide the grievant or, if involved, the LAP, with the documents that may be considered in making a decision on the grievance. #### Regulation .06 Grievance Procedure Stage 1: Rights Advisor's Role. *COMAR 10.21.14.06* A. Rights Advisor's Investigation and Mediation. (1) The rights advisor shall respond to the grievance by meeting with: (a) The grievant; (b) The individual filing the grievance, if other than the resident; (c) The grievant's LAP, if involved; and (d) If applicable, any witness to the incident. (2) Except for good cause, the rights advisor shall notify the grievant before reviewing the grievant's medical record. B. The rights advisor shall: (1) Determine an appropriate course of action for processing the grievance, which may include, but is not limited to: (a) Interviews in person or by telephone; (b) Requests for documents and correspondence; (c) Notification to the grievant regarding the facility's clinical review panel option if the grievance relates to a grievant's refusal to take medication prescribed for treatment of a mental disorder; and (d) Classification of alleged rights violations in accordance with guidelines developed by the Director of the RGS; (2) Keep the grievant informed of all steps taken to resolve the grievance; and (3) Render a decision on a grievance within 10 working days of receipt of the grievance. C. The rights advisor shall make every effort to negotiate, mediate, and resolve the grievance fairly at this stage. If action is taken and the grievant is satisfied, the case is closed. D. If, as a result of the rights advisor's professional judgment, a grievance is determined to be frivolous, the rights advisor shall inform the grievant of that finding and of the grievant's right to appeal and the appeal procedure. E. If a grievance with merit is not resolved to the grievant's satisfaction, and the grievant wishes to appeal, the rights advisor shall forward a copy of the grievance, including a description of the issues and recommendations, to the unit director as outlined in Regulation .07 of this chapter. F. If, in the rights advisor's professional judgment, the nature of the grievance is not frivolous, but the grievance either cannot be substantiated or appears to have no merit, the rights advisor shall: (1) Inform the grievant of the decision and the right to appeal; (2) With the consent of the grievant, assist the grievant in filing an appeal; and (3) Document the findings and forward a copy of the report describing the findings to: (a) The Director of the RGS; (b) The unit director; (c) The grievant; (d) If involved, the grievant's LAP; and (e) The CEO. G. If a grievance with merit is resolved to the grievant's satisfaction, the rights advisor shall forward a copy of the decision to: (1) The unit director; (2) The grievant; (3) The CEO; and (4) If involved, the grievant's LAP. H. If the rights advisor's initial investigation concludes there is substantial risk of serious harm, or there is the potential for serious harm to a grievant if the alleged violation is not remedied promptly: (1) The rights advisor shall inform immediately the: (a) Unit director or the unit director's designee; (b) CEO or the CEO's designee; (c) Director of the RGS; and (d) Director of the Behavioral Health Administration or the Behavioral Health Administration Director’s designee; and (2) The unit director, the CEO, or their respective designees shall: (a) Perform an investigation; and (b) If the grievance is substantiated, develop and implement a solution within 24 hours of receiving the rights advisor's report. #### Regulation .07 Grievance Procedure Stage 2: Unit Director's Response. *COMAR 10.21.14.07* A. The unit director shall: (1) Review the rights advisor's report; (2) Discuss the matter with any individual involved; and (3) Within 5 working days of receipt of the report, decide whether to: (a) Accept the rights advisor's report, completely or in part with respect to the facts as found; or (b) Modify or reject the recommendations made by the rights advisor. B. The unit director shall write and forward a decision to the rights advisor, who shall forward copies to the grievant, the CEO and, if involved, the grievant's LAP. C. If the unit director concludes that a grievance has been substantiated and requires remedial action, the unit director immediately shall: (1) Notify the CEO and, if indicated, the clinical director; and (2) Provide a remedy, which may include, but is not limited to: (a) Directing a change in practice; or (b) Seeking approval for changes in policy. D. If the grievant is: (1) Satisfied with the action taken by the unit director, the grievance ends at this stage; or (2) Dissatisfied with the action taken by the unit director and wishes to pursue the grievance, the rights advisor shall: (a) If the grievant requests the review, request a review by the residents' rights committee, notifying the CEO of the request for the review; and (b) Subsequently request a review by the CEO. #### Regulation .08 Grievance Procedure Stage 3: CEO's Review with an Optional Review by the Residents' Rights Committee. *COMAR 10.21.14.08* A. If the grievant requests a review by the residents' rights committee before the CEO's review, the residents' rights committee shall: (1) Meet within 15 working days of receipt of the grievance; (2) Review the information obtained by the rights advisor; (3) Review information presented by the grievant; (4) Review the decision of the unit director; (5) If involved, review information presented by the LAP; (6) Review all relevant data pertaining to the grievance; and (7) Forward written recommendations to the CEO. B. A review by the residents' rights committee: (1) May include further investigation into the circumstances of the grievance; (2) May not be limited to consideration of the record of the grievance from prior proceedings; and (3) At the request of the grievant, may be waived. C. The rights advisor: (1) Shall notify all interested persons, including involved staff, the grievant, and, if involved, the grievant's LAP of the time and location of the residents' rights committee meetings; (2) Shall present information obtained at prior proceedings; (3) Shall inform the grievant and, if involved, the grievant's LAP of all recommendations made by the residents' rights committee; and (4) May not be present during the residents' rights committee deliberations. D. All interested persons including involved staff, the grievant, and, if involved, the grievant's LAP: (1) Shall be invited to attend the residents' rights committee meeting to present information relating to the grievance; and (2) May not be present during residents' rights committee deliberations. E. Upon receipt of the residents' rights committee's recommendations, the CEO or the CEO's designee shall: (1) Determine what action, if any, is to be taken; and (2) Notify the residents' rights committee in writing of any action taken. F. Completion of time periods specified within stage 3 are dependent upon the following: (1) If the LAP is involved, the CEO or the CEO's designee: (a) Shall respond within 15 working days to the residents' rights committee's recommendations; and (b) May request an oral presentation from the LAP, if the LAP submits a written summary of the presentation before the meeting; (2) If the LAP is not involved, the CEO or the CEO's designee shall respond within 5 working days to the residents' rights committee's recommendations. G. The CEO or the CEO's designee shall write and forward a decision to the rights advisor. H. The rights advisor shall forward copies of the decision of the CEO or the CEO's designee to: (1) The grievant; (2) If involved, the grievant's LAP; (3) The Director of the RGS; (4) If involved, the residents' rights committee; and (5) The unit director. I. If the CEO or the CEO's designee substantiates the grievance, the CEO or the CEO's designee shall identify in the decision: (1) The corrective action to provide a complete remedy to the grievant for the violation; and (2) Time frames, consistent with this chapter, for implementing the corrective action. J. If the grievant is: (1) Satisfied with the action taken by the CEO or the CEO's designee, the grievance ends at this stage; or (2) Dissatisfied with the decision of the CEO or the CEO's designee, the rights advisor shall inform the grievant of the appeal process to the Central Review Committee. K. If requested by the grievant, the rights advisor shall file an appeal to the Central Review Committee within 5 working days after receipt of the decision by the CEO or the CEO's designee. #### Regulation .09 Grievance Procedure Stage 4: Central Review Committee Response. *COMAR 10.21.14.09* A. The Central Review Committee: (1) Shall meet within 10 working days of receipt of an appeal; (2) Shall review all prior information concerning the grievance; (3) May perform an investigation of the grievance which shall be accomplished within 10 additional working days; and (4) At the request of the grievant, may sequester those who are presenting information to the Committee. B. For a grievance that is initiated after the effective date of this chapter, if a LAP is representing a grievant, the Central Review Committee, at the request of the grievant, shall: (1) Allow the LAP to be present for argument or while evidence is presented by any other person; and (2) Hear a presentation from the LAP before making a decision, if the LAP submits a written summary of the presentation before the meeting. C. The Central Review Committee shall write and forward a decision to: (1) The CEO of the facility; (2) The grievant; (3) If involved, the grievant's LAP; (4) The rights advisor; and (5) If involved, the residents' rights committee. D. If the grievant is: (1) Satisfied with the decision of the Central Review Committee, the case is closed; or (2) Dissatisfied with the decision of the Central Review Committee, the rights advisor shall promptly inform the grievant of additional relevant legal services which the grievant may contact. E. Notification of Status. (1) Within 20 working days, the Central Review Committee, through the Director of the RGS, shall request from the facility CEO a written report of the status of the implementation of the recommendations made during the grievance process. (2) Until the decision is fully implemented, the CEO shall make periodic reports to the Central Review Committee through the RGS Director every 30 days. #### Regulation .10 Resident Grievance System Reports. *COMAR 10.21.14.10* A. The Director of the RGS shall ensure that RGS reports: (1) May not be released to other persons except as provided within this chapter; and (2) Identify the alleged violations, the decision, and the remedy. B. With the identity of those involved in the grievance deleted, the Director of the RGS shall ensure that the decisions on all 4th-stage grievances be: (1) Included in the annual report of the RGS Director; (2) Made available for public review at the Department's Resident Grievance System Office; (3) Sent to other rights advisors; (4) Sent to the Deputy Secretary for Public Health Services, the LAP, and members of the Coe Board of Review; and (5) Sent to the Behavioral Health Administration facility CEOs. C. With the identity of those involved in the grievance deleted, all decisions with Statewide impact, as determined by the Director of the RGS, shall be: (1) Circulated to those enumerated in §B of this regulation; and (2) Sent to all Behavioral Health Administration personnel involved in or affected by the decision. D. RGS reports and other documents concerning a grievance may not be placed in the resident's medical record unless otherwise required by law. #### Regulation .11 Personnel Provisions. *COMAR 10.21.14.11* A. A facility may not place the reports of the RGS in an employee's personnel file. B. The rights advisor may not be a witness in an agency proceeding against an employee, unless the rights advisor is a first-hand witness to events being reviewed. C. If allegations are made against an employee: (1) The rights advisor shall immediately give the employee and the employee's Department head a copy of the information relevant to the allegation; and (2) Within 5 working days of receipt of the information, the employee shall respond, in writing, to the rights advisor assigned to that facility. D. Notice of Grievance Decision. (1) The rights advisor shall give written notice of a grievance decision involving an employee to the director of the division of personnel and the employee's Department head at the facility. (2) The personnel director shall forward a copy of the notice in §D(1) of this regulation to the employee, the employee's supervisor, and the employee's Department head. E. Nothing shall prevent a facility from taking appropriate action against an employee for events which come to the attention of the facility through the RGS. F. The RGS may not affect employee rights as mandated by State Personnel and Pensions Article, Annotated Code of Maryland. #### Regulation .12 External Legal Action. *COMAR 10.21.14.12* A. This chapter does not modify the resident's: (1) Legal rights; (2) Access to seek private legal counsel from attorneys not receiving funding for legal assistance from the Maryland Department of Health; or (3) Access to a court. B. The Resident Grievance System is not governed by the contested case provisions of the Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland. ### Chapter 15 — Petition for Emergency Evaluation — Payment for Services **Authority:** Health-General Article, §10-628, Annotated Code of Maryland **Administrative History:** Effective date: May 9, 1994 (21:9 Md. R. 751) #### Regulation .01 Scope. *COMAR 10.21.15.01* These regulations govern payment for specific emergency services, as defined in Health-General Article, §10-628, Annotated Code of Maryland, rendered as a direct consequence of a petition for emergency evaluation. #### Regulation .02 Definitions. *COMAR 10.21.15.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Consultant” means a physician, licensed by the State, who is not a salaried staff member of the emergency facility and who is authorized by the emergency facility to perform an examination of an emergency evaluee. (2) “Department” means the Maryland Department of Health. (3) “Designated emergency facility” means a health care organization currently identified by the Department to perform the functions identified in Health-General Article, §10-624, Annotated Code of Maryland, or this chapter, or both. (4) “Emergency evaluee” means an individual who has been referred to a designated emergency facility on the basis of a petition for emergency evaluation. (5) “Emergency service” means the service rendered as a direct result of the execution of a valid petition. (6) “Emergency vehicle” means: (a) A vehicle operated by a law enforcement officer; or (b) An ambulance regulated according to COMAR 14.22.01 — 14.22.12. (7) “Examination” means a face-to-face diagnostic interview and examination by a consultant physician that includes a medical history, an assessment of mental status, a neurological examination, an assessment of dangerousness, and a written report outlining the consultant physician's findings and conclusions. (8) “Inpatient facility” means an inpatient institution that provides evaluation, care, or treatment for individuals who have mental disorders. (9) “Petition” means a petition for emergency evaluation that is made by an individual who has reason to believe that the emergency evaluee has a mental disorder and that there is danger of the emergency evaluee's doing bodily harm to the petitioner or another individual. (10) “Provider” means an individual, an association, a partnership, an incorporated or unincorporated group, or a hospital that renders health care service to an emergency evaluee. #### Regulation .03 Conditions for Payment. *COMAR 10.21.15.03* The Department shall pay for emergency service only if: A. As determined according to Health-General Article, §16-202, Annotated Code of Maryland, the emergency evaluee cannot pay the charge for the service; and B. The emergency evaluee does not have health insurance, including Medicare or Medical Assistance, that covers the allowable payment for the service. #### Regulation .04 Payable Services. *COMAR 10.21.15.04* The Department shall limit services payable under this chapter to the following emergency services: A. The basic emergency room fee in a designated emergency facility; B. The initial examination performed in the emergency room of a designated psychiatric emergency facility by a consultant physician; and C. Transportation for the emergency evaluee in an emergency vehicle: (1) From the site where the emergency evaluee is located to the designated emergency facility; and (2) If staff at the emergency facility complete an application and two certificates for involuntary admission according to the provisions of Health-General Article, §§10-615 — 10-616, Annotated Code of Maryland, from the designated emergency facility to the inpatient facility where the emergency evaluee is referred for admission. #### Regulation .05 Billing Procedures. *COMAR 10.21.15.05* A. The provider shall submit the following documents: (1) A request for payment on a form designated by the Department; (2) A bill that specifies the: (a) Name of the emergency evaluee; (b) Date of service; and (c) Description of service; (3) A copy of the current petition for emergency evaluation; (4) If the bill is for an examination by a consultant physician, a copy of the consultant physician's evaluation that is signed by the examining consultant physician; (5) If the bill is for transportation of an emergency evaluee from a designated emergency facility to an inpatient facility, copies of both completed certificates for involuntary admission and the application for involuntary admission; and (6) Any other documentation required by the Department to determine that the conditions of this chapter have been met. B. The provider shall submit the request for payment within 12 months of the date of service. C. The Department may refuse a request for payment if the request is not accompanied by properly completed forms and documents required under §A of this regulation. #### Regulation .06 Payment Rates. *COMAR 10.21.15.06* The Department shall pay: A. Hospitals, at rates approved by the Health Services Cost Review Commission; B. Physicians, the lesser of the: (1) Amount billed; or (2) The Statewide average of prevailing charges for an examination by a physician consultant based on Medicare's 75th percentile as determined according to 42 CFR Sec. 405.504; and C. Transportation providers, if transportation is by: (1) Ambulance, the lesser of the: (a) Amount billed; or (b) The Statewide average of prevailing charges for an ambulance based on Medicare's 75th percentile; or (2) A law enforcement officer in an emergency vehicle: (a) The cost per mile based on the county's established rates for emergency vehicles; and (b) The cost of the law enforcement officer's hourly wage for the number of hours, not to exceed 4 hours, required to transport the emergency evaluee. #### Regulation .07 Subrogation by the Department. *COMAR 10.21.15.07* A. Before billing the Department, the provider shall: (1) Take all reasonable steps to collect the charge from the emergency evaluee and, if applicable, from insurers, including Medicare and Medical Assistance; or (2) Make and document a determination of the evaluee's inability to pay, according to the provisions of Regulation .03 of this chapter. B. A provider: (1) Shall accept as payment in full the maximum payment amount allowable under Medicare for services rendered to eligible participants; and (2) May not bill the Department for any amount in excess of that allowable under §B(1) of this regulation. C. If a provider receives payment from both the Department and another source, within 30 calendar days of receipt of payment by the other source, the provider shall refund to the Department the amount in excess of the maximum payment allowable under the provisions of §B of this regulation that was paid by the Department. D. The provider shall immediately reimburse the Department for any overpayment. #### Regulation .08 Patients' Rights. *COMAR 10.21.15.08* A. Access to Care. Providers of emergency services shall give an emergency evaluee equal access to treatment and services that are available or medically indicated, regardless of diagnosis, handicap status, race, age, sex, national origin, religious or political opinions or affiliations, or sources of payment for care. B. Providers of emergency services shall recognize and respect an emergency evaluee's dignity in the provision of care and treatment. C. Confidentiality. (1) The emergency evaluee's medical record is governed by the provisions of confidentiality as set forth in Health-General Article, Title 4, Subtitle 3, and §19-308.2, Annotated Code of Maryland. (2) The right of confidentiality does not preclude routine audit or payment processes. ### Chapter 16 — Community Mental Health Programs — Application, Approval, and Disciplinary Processes **Authority:** Health-General Article, §§7.5-205, 10-901, and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: January 2, 1995 (21:26 Md. R. 2187) **Administrative History:** Chapter revised effective October 5, 1998 (25:20 Md. R. 1529) **Administrative History:** Regulations .01 — .12 repealed and new Regulations .01 — .16 adopted effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .04C amended effective March 13, 2017 (44:5 Md. R. 292) #### Regulation .01 Scope. *COMAR 10.21.16.01* A. This chapter outlines the process for application for, denial of, and disciplinary action on, the approval for a program to be eligible to receive State or federal funds for providing community mental health services. B. This chapter does not apply to programs approved under COMAR 10.21.07 Therapeutic Group Homes or Federally Qualified Health Centers. #### Regulation .02 Definitions. *COMAR 10.21.16.02* In this chapter, terms have the meanings indicated in COMAR 10.21.17. #### Regulation .03 Approval Requirements. *COMAR 10.21.16.03* To be eligible for approval under this chapter, a program shall: A. Meet the requirements of: (1) This chapter; (2) COMAR 10.21.17; (3) The chapter under this subtitle that outlines the requirements for the specific program; and (4) Medical Assistance regulations, including, but not limited to COMAR 10.09.36, 10.09.59. and 10.09.70; and B. Demonstrate compliance with: (1) Relevant federal, State, or local ordinances, laws, regulations, and orders governing the program; and (2) The satisfactory fire, safety, and health inspection reports of the site that are required by the local jurisdiction, if a program provides services at a site whose primary function is the delivery of mental health services. #### Regulation .04 Application Process. *COMAR 10.21.16.04* A. Consultation. Before submitting an application, an applicant for approval of a program may request assistance from the Department's designated approval unit or the appropriate core service agency (CSA) director regarding the proper compilation of application materials and completion of the application. B. Lead CSA Determination. For programs providing services in multiple jurisdictions, the Administration, in collaboration with the appropriate CSAs, shall determine the lead CSA. C. Application. An applicant for approval of a program shall: (1) Submit an application to the Department’s designated approval unit; (2) Submit the application on the written or electronic form approved by the Department, with all questions answered and all required documents attached; (3) Include in the application, at a minimum, the following information: (a) Documentation of the applicant's program service plan, as outlined in Regulation .05 of this chapter; (b) A written business plan that clearly demonstrates the program's ability to provide services in accordance with applicable Maryland regulations and Medicaid and Medicare funding requirements; (c) Information to demonstrate the program's financial viability, including, but not limited to: (i) Salary structure; (ii) Client mix; (iii) Anticipated administrative expenses; (iv) Necessary cash reserves to maintain the program during the start-up phase and a financial crisis; (v) Identification of the individual responsible for providing the required financial information; and (vi) Other information deemed necessary by the Department; (d) A summary of the program's demonstrated experience in the field of mental health; (e) Prior licensing reports issued within the previous 10 years from any in-State or out-of-State entities associated with the program, including deficiency reports and compliance records from which the Department may make reasoned decisions about the qualifications of the program; (f) Disclosure of: (i) Any license or approval revocation within the previous 10 years by the Department or other licensing agency; (ii) Whether the program, or corporation or entity associated with the program, has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years; and (iii) Any corporate officer who has served as a corporate officer for a corporation or entity that has had a license revoked, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action within the previous 10 years; (g) A written quality assurance plan that addresses how the organization will ensure the health and safety of the individuals served by the program and the quality of services provided to individuals by the program; and (h) For 26 U.S.C. §501(c)(3) organizations, a statement of how the organization intends to satisfy its charitable mission; and (4) Forward a copy of the: (a) Completed application to the: (i) CSA of the jurisdiction where the program services are to be delivered; or (ii) For programs providing services in multiple jurisdictions, lead CSA identified under §B of this regulation; and (b) Application cover letter to the Administration and all CSAs of the jurisdictions where the program plans to deliver services. D. Action by the CSA or Lead CSA. The CSA, or lead CSA identified under §B of this regulation, shall submit to the Department's designated approval unit: (1) Verification that: (a) The program agrees to collaborate with all CSAs where the program proposes to provide services, according to the provisions of COMAR 10.21.17.06; and (b) The financial information submitted under §C of this regulation appears to demonstrate potential financial viability of the program; and (2) Comments, if any, on the content of the application. E. Application Modification. (1) A program that proposes to change its program sites by adding, closing, or moving locations shall submit an application modification, on the form required by the Department, to the Department's designated approval unit. (2) If the Department's designated approval unit approves the application modification, the existing program approval shall extend to the additional site, as applicable. #### Regulation .05 Program Service Plan (PSP). *COMAR 10.21.16.05* On the forms approved by the Administration as part of the application required under Regulation .04C of this chapter or COMAR 10.21.04.05B, a program shall submit a PSP that includes a description of: A. The range of services that the program will provide; B. The populations to be served, including age groups and other relevant characteristics, and the number of individuals that the program expects to serve; C. Program sites and hours of operation, and the method to ensure that services are accessible to the individuals served; D. The goals, objectives, and expected outcomes of the program; E. The composition of the program's governing body, board of directors, or advisory committee, whichever applies, as outlined in COMAR 10.21.17.05A; F. The jurisdictions where services will be provided and the number of services to be provided in each jurisdiction; and G. The jurisdiction where most of the program's services will be rendered. #### Regulation .06 Evaluation of Application. *COMAR 10.21.16.06* A. The Department's designated approval unit shall evaluate the application to determine whether the applicant adequately documents that the: (1) Proposed program has met all approval requirements; (2) Applicant has reviewed and is knowledgeable regarding all applicable regulations; and (3) Program will be financially viable. B. Before making a determination under §A of this regulation, the Department's designated approval unit may: (1) Request clarification of application materials; and (2) Consult with the CSA director, or lead CSA director, and the Administration. C. Before determining that a program is eligible for approval under this or any other chapter of the Administration's regulations, the Department shall conduct an on-site investigation of the program and meet with the applicant. #### Regulation .07 Temporary Approval. *COMAR 10.21.16.07* A. If the Department's designated approval unit determines that the program meets all approval requirements, the Secretary shall: (1) Issue temporary approval according to the provisions of §B of this regulation; and (2) Forward copies of the approval to the: (a) Appropriate CSA; (b) Administration; (c) ASO; (d) Medical Assistance Program; and (e) The program's chief executive officer (CEO) and president of the advisory committee or governing body, whichever applies. B. Duration of Temporary Approval. (1) The temporary approval is valid for a period of not more than 6 months unless: (a) Before the end of 6 months, the program requests an extension due to a delay in beginning operations; and (b) Upon the recommendation of the Department's designated approval unit, the Secretary grants an extension of not more than 6 months. (2) If a program is granted an extension of temporary approval under §B(1)(b) of this regulation, and the program fails to begin operation during the effective date of the extension, the program's approval automatically ceases. C. Denial of Temporary Approval. (1) The Department may deny temporary approval to an applicant if the Department's designated approval unit determines that the application does not meet all approval requirements. (2) The Department may deny a license or approval to: (a) Any corporation or entity that has had a license or approval revoked by the Department or other licensing agency, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years; and (b) Any corporation or entity that has a corporate officer who has served as a corporate officer for a corporation or entity that has had a license revoked, or has surrendered or defaulted on its license or approval for reasons related to disciplinary action, within the previous 10 years. (3) The Secretary may, according to the provisions of Regulation .12A of this chapter, issue an initial notice of proposed denial of temporary approval. (4) If the Secretary takes the action in §C(1) or (2) of this regulation, the Secretary shall advise the applicant of hearing rights, as described in Regulations .12A and .16 of this chapter. D. Before the expiration of a temporary approval period: (1) The Department's designated approval unit shall conduct an on-site review to determine approval status outlined in Regulation .08 of this chapter; and (2) Following completion of the on-site review required under §D(1) of this regulation, the Secretary shall grant or propose to revoke approval according to the provisions of Regulation .08 or .12 of this chapter. #### Regulation .08 Approval of a Program. *COMAR 10.21.16.08* A. Approval Without Conditions. (1) The Secretary shall grant approval without conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program complies with the requirements for approval. (2) Unless the program has been granted deemed status under Regulation .10 of this chapter, within not more than 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program. (3) Based on the review conducted under §A(2) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter. B. Approval with Conditions. (1) The Secretary may grant approval with conditions to a program if, based on an on-site review, the Department's designated approval unit determines that the program: (a) Is deficient in one or more of the requirements under this chapter, COMAR 10.21.17, or the chapter under the subtitle for the specific program; (b) Has no deficiencies that constitute a threat to health, safety, or welfare of the individuals served; (c) Has documented that the program will collaborate with the CSA, as required under COMAR 10.21.17.06; and (d) Has submitted an acceptable program improvement plan within the time frame established under §B(3) of this regulation. (2) If the Secretary grants a program an approval with conditions under §B(1) of this regulation, the Secretary shall notify the program that the Department's designated approval unit may conduct a focused review under the provisions of §B(4) of this regulation. (3) Program Improvement Plan (PIP). (a) Within 10 working days of receipt of the list of deficiencies cited during the on-site review, the program director shall: (i) Submit a proposed PIP that addresses the identified deficiencies to the CSA or lead CSA; and (ii) Collaborate with the CSA or lead CSA to finalize the PIP. (b) Within 30 calendar days of receipt of the list of deficiencies cited during the on-site review, the program director shall submit: (i) The PIP to the Department's designated approval unit; and (ii) Documentation of the collaboration with the CSA or lead CSA. (c) Unless an extension has been granted by the Department's designated approval unit, if a program fails to submit a completed PIP within the time frames established in §B(3)(a) and (b) of this regulation, the Secretary may pursue disciplinary action under Regulation .12C of this chapter. (4) Focused Review. (a) For programs that have been granted approval with conditions, the Department's designated approval unit may conduct a focused review to: (i) Reevaluate the deficiencies cited during the on-site review conducted under §B(1) of this regulation; and (ii) Review the program's progress on the PIP. (b) Based on the focused review conducted under §B(4)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter. (5) Regular Program Review. (a) Within 3 years of the date of the program's last full on-site review, the Department's designated approval unit shall conduct a full, on-site review of the program. (b) Based on the review conducted under §B(5)(a) of this regulation, the Secretary shall redetermine the program's approval status according to the provisions of this chapter. C. Certificate of Approval. (1) If the Department's designated approval unit determines that a program is eligible for approval, the Secretary shall issue a certificate of approval to the program director that specifies the: (a) Chapter under which the program has been approved; (b) Type of approval; and (c) Beginning and expiration dates of the approval period. (2) The Secretary shall notify the Administration, the CSA of the jurisdiction where the program provides services, the Medical Assistance Program, and the ASO of the program's approval. (3) The program director shall ensure that the certificate of approval is available during the regular hours of operation. (4) Sale or Transfer of Certificate of Approval. (a) The Secretary's certificate of approval of a program, issued according to the provisions of §C(1) of this regulation, is valid only for the program to which the Secretary's certificate of approval is issued. (b) A program may not sell, assign, or transfer a certificate of approval to another program. D. Extension of Approval Status. The Secretary shall maintain the program's existing approval status if, before the expiration of approval period, the: (1) Department's designated approval unit does not complete an on-site review; or (2) Department does not reach a decision regarding approval. #### Regulation .09 Waivers and Variances. *COMAR 10.21.16.09* A. Waivers. The Secretary may not waive the requirements of any regulation adopted under: (1) This chapter; (2) COMAR 10.21.17; or (3) The chapter under this subtitle that outlines the requirements for a specific program. B. Variances. (1) A program that is approved under Regulation .08 of this chapter may apply for a variance. (2) When a program is approved under Regulation .08 of this chapter, the Secretary may grant a variance for a regulation if the Secretary: (a) Receives a written request from a program on the form required by the Administration; and (b) Finds that the intent of the regulation to which a variance is sought is met by the alternative proposed by the program. (3) The Secretary may not grant a variance that would endanger the health or safety of the individuals served. (4) The Secretary may grant a variance that: (a) Remains in effect for as long as the program continues to comply with the conditions under which the variance is granted; or (b) Is time limited. (5) The Secretary shall: (a) Issue a written decision, including the reason or reasons for granting or not granting the variance; (b) Send the decision to the: (i) Program director; (ii) CSA; and (iii) Department's designated approval unit; and (c) Enter the decision in the records of the Department. #### Regulation .10 Deemed Status. *COMAR 10.21.16.10* A. Initial Request for Deemed Status. If a program is approved under Regulation .08 of this chapter and is accredited under relevant behavioral health care standards of the Joint Commission on the Accreditation of Health Care Organizations (JCAHO) or the Rehabilitation Accreditation Commission (CARF), the program director may request that the Secretary grant the program deemed status by submitting a written request to the Administration and the CSA at least 90 days before the expiration of the program's current approval status that includes the: (1) Application for deemed status; (2) Accreditation body's full report, including the program's status and any conditions placed on the program; (3) Most recent report by the Department's designated approval unit; and (4) Program improvement plans, if any, required by the accreditation body or the Department's designated approval unit. B. Request for Renewal of Deemed Status. The program may request that the Secretary renew the program's deemed status by submitting a written request to the Administration at least 60 calendar days before the expiration of the program's current deemed status that includes the: (1) Application for deemed status renewal; (2) Most recent accreditation body's full report, including the program's status and any conditions placed on the program; (3) Program improvement plan, if any, required by the accreditation body; and (4) Documentation of verification from the CSA or lead CSA, of program compliance with the conditions, if any, outlined under §D(1)(b) of this regulation. C. Evaluation of Request for Initial Deemed Status or Renewal of Deemed Status. Within 60 calendar days of receipt of the request under §A or B of this regulation: (1) The Administration, in consultation with the CSA or lead CSA, and the Department's designated approval unit: (a) Shall evaluate the request for deemed status; (b) May meet with the program director; and (c) May arrange for an on-site evaluation; and (2) The Director shall recommend to the Secretary a decision regarding deemed status, based on: (a) Comparison of the standards used by the accreditation body with the chapter under this subtitle that outlines the requirements for the specific program; and (b) The results of an on-site evaluation, if any. D. Decision Regarding Deemed Status. Based on the evaluation of the request for deemed status conducted under §C of this regulation, the Secretary shall: (1) Decide whether to: (a) Approve deemed status; (b) Approve deemed status with conditions, which may include evaluation by the Department's designated approval unit; or (c) Propose to deny approval of deemed status; and (2) Send notice of the decision to the: (a) Department's designated approval unit; (b) Program director; (c) Administration; and (d) CSA or lead CSA. E. Denial of Deemed Status. (1) If the Secretary proposes to deny approval of deemed status, the Secretary shall give written notice of the proposed denial to the: (a) Department's designated approval unit; (b) Program director; (c) Administration; and (d) CSA or lead CSA. (2) In the notice under §E(1) of this regulation, the Secretary shall include: (a) The date that the Secretary proposes to deny approval of deemed status; and (b) The facts that warrant the proposed denial of deemed status. (3) Upon receipt of the notice under §E(2) of this regulation, the program director may: (a) Withdraw the request for deemed status; and (b) Request an on-site review for approval by the Department's designated approval unit. (4) If the program director does not take the action under §E(3) of this regulation and if, after notice and opportunity to be heard, the Secretary denies approval of deemed status, the Director shall notify the program director that, unless the program elects not to seek approval, the Department's designated approval unit shall conduct an on-site review for the purpose of granting or denying approval under Regulation .08 or .12 of this chapter. #### Regulation .11 Program Inspection and Investigation by the Department. *COMAR 10.21.16.11* The Department, its designees, the Administration, the Administration's ASO, CSA, and federal funding agents may: A. Make announced and unannounced visits to a program; and B. Inspect and copy all records, including, but not limited to financial, treatment, and service records. #### Regulation .12 Denial, Emergency Suspension of Approval, and Disciplinary Action. *COMAR 10.21.16.12* A. Denial of Approval. (1) If the Secretary proposes to deny approval to an applicant under the provisions of this chapter, the Secretary shall give written notice of the proposed denial to the: (a) Applicant; (b) Program's CEO and president of the advisory committee or governing body, whichever applies; (c) Administration; (d) CSA or lead CSA; (e) ASO; and (f) Medical Assistance Program. (2) In the notice under §A(1) of this regulation, the Secretary shall include: (a) The date on which the Secretary proposes to deny approval; (b) The facts that warrant the proposed denial of approval; (c) Citation of the regulation or regulations upon which the proposed denial is based; and (d) Notification: (i) That before the denial of approval, the program may request a hearing under the provisions of Regulation .16 of this chapter; and (ii) When feasible, of a case resolution conference. B. Emergency Suspension of Approval. (1) Under State Government Article, §10-226, Annotated Code of Maryland, upon findings of conditions that pose an imminent risk to the health, safety, or welfare of an individual served by a program, the Secretary may order the immediate suspension of the approval of the program and the cessation of operation. (2) If the Secretary takes the action under §B(1) of this regulation, the Secretary shall promptly give written notice of the proposed emergency suspension to the: (a) Program director; (b) President of the program's advisory committee, board of directors, or governing body, whichever is applicable; (c) Administration; (d) CSA or lead CSA; (e) Department's designated approval unit; (f) ASO; and (g) Medical Assistance Program. (3) In the notice under §B(2) of this regulation, the Secretary shall include: (a) The proposed effective date of the emergency suspension; (b) When feasible, the date of a pre-deprivation hearing and a case resolution conference prior to the Department's final action; (c) The findings under §B(1) of this regulation and the reasons that support the finding; (d) Notification that: (i) Following the emergency suspension, the program may request a hearing under the provisions of Regulation .16 of this chapter; and (ii) The emergency suspension may lead to revocation of the approval if the violation or violations are not corrected within the time period specified by the Department. (4) If the Secretary suspends approval, the program director shall immediately: (a) Notify individuals or the guardians of individuals receiving services of the suspension; (b) Cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program; and (c) Cease operations of the program. C. Disciplinary Action. (1) The Secretary may propose to take any of the following disciplinary actions against a program: (a) Revocation of approval; (b) Suspension of approval; (c) Probation with conditions; or (d) Banning new admissions. (2) The Secretary may propose to take one of the actions outlined in §C(1) of this regulation if the program: (a) Is out of compliance with the requirements of: (i) This chapter; (ii) COMAR 10.21.17; or (iii) The chapter under this subtitle that outlines the requirements for the specific program; (b) Fails to maintain financial viability; or (c) Obtains or attempts to obtain approval by fraud, misrepresentation, or the submission of false information to the Secretary. (3) Except under §B of this regulation, no less than 45 calendar days in advance of the proposed action taken under this regulation, the Secretary shall send written notice of the proposed action to the: (a) Program director; (b) President of the program's advisory committee, board of directors, or governing body, whichever is applicable; (c) Administration; and (d) CSA or lead CSA. (4) In the notice under §C(3) of this regulation, the Secretary shall include: (a) The date on which the Secretary proposes to take action, and when feasible, the date of a case resolution conference; (b) The facts that warrant the proposed action; (c) Citation of the regulation or regulations upon which the proposed action is based; and (d) Notification that, before the action, the program has the right to request a hearing under the provisions of Regulation .16 of this chapter. (5) If, after notice and opportunity to be heard, the Secretary takes disciplinary action, the program director shall, within 10 working days: (a) Notify individuals or the guardians of individuals receiving services of the action; and (b) If the program ceases operations: (i) Notify the CSA or lead CSA and the Administration of the cessation; and (ii) Cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program. #### Regulation .13 Program Request for Discontinuation of Operations. *COMAR 10.21.16.13* A. If a program intends to discontinue operation, the program director shall, no less than 60 calendar days before the program intends to discontinue operation, submit to the Department's approval unit, the Administration, and the lead CSA its written plan for: (1) Cessation of operations, including relevant dates; (2) Transitioning individuals within its program to other mental health services; (3) Storing and protecting all records; (4) Notifying employees, consultants, and consumers of its cessation of operations; (5) If a nonprofit organization, the return of funds to the State, as required; (6) Reimbursement of employees for lost benefits, such as sick leave, vacation, and pension plan transitions; and (7) An audited financial statement, current as of the date of the request to discontinue operations. B. Within 30 days of receipt of the program's request to discontinue operations, the Department's approval unit shall: (1) Notify the program in writing whether its plan is acceptable; and (2) If the plan is unacceptable, meet with the program and the lead CSA to formulate a plan that protects the health, safety, and welfare of the individuals served by the program and program staff. C. The program may not discontinue operations until the Department's approval unit authorizes this discontinuation. D. The program shall be responsible for delivering services to the individuals in its program until such time as the Department's approval unit approves the discontinuation. E. The program shall surrender its approval to provide services concurrent with the date on which it ceases operation. F. At all times, the program shall cooperate with the Administration, the Department's approval unit, and the lead CSA. G. Failure to comply with any section of this regulation may result in monetary penalties against the program's surety bond. H. If a program that is discontinuing operation does not comply with §§A — F of this regulation, the Secretary may deny approval to any future application that the program, or principals of the program, may submit. #### Regulation .14 Program Request for Discontinuation of Approval. *COMAR 10.21.16.14* A. If a program wishes to discontinue approval, the program director shall, not less than 60 calendar days before the date the program wishes to discontinue approval: (1) Submit to the Department's designated approval unit a letter requesting discontinuation of approval; and (2) Notify, in writing, the: (a) Individuals or the guardians of individuals receiving services that the program has requested discontinuation of approval, and the effective date of the discontinuation; and (b) CSA or lead CSA, the Administration, Medical Assistance Program, and the ASO of the discontinuation of approval and the effective date of discontinuation. B. Within 60 calendar days from the receipt of the request for discontinuation of approval, the Secretary shall: (1) Notify, in writing, the program director of the discontinuation of the program's approval and the effective date; and (2) Forward a copy of the discontinuation to the Administration, Medical Assistance Program, CSA, and the ASO. C. When a program's decision to discontinue approval results in the discontinuation of services to any individual receiving services, the program director shall cooperate with the CSA or lead CSA and the Administration in accessing appropriate alternate services for individuals in the program. #### Regulation .15 Initiation of Receivership. *COMAR 10.21.16.15* The Secretary may take action to initiate receivership under the provision of Health-General Article, §§19-333 — 19-339, Annotated Code of Maryland. #### Regulation .16 Procedures for Hearings. *COMAR 10.21.16.16* A. If the Secretary proposes to deny approval or initiate disciplinary action, the Secretary shall give the program director written notice of the proposed action, according to the provisions outlined in Regulation .12A — C of this chapter. B. Within 10 working days of receipt of the notification of the action under §A of this regulation, the program director may file a written request for a hearing with the Office of Administrative Hearings, with copies to the: (1) Administration; (2) CSA or lead CSA; and (3) Director of the Department's designated approval unit. C. If the program director does not file a request for hearing that is postmarked within 10 working days of receipt of the notification, the program waives the right to request a hearing, and the Secretary may effect the proposed action. D. If a timely request for hearing has been received, the Office of Administrative Hearings shall: (1) Notify the Director and the program director of the date, time, and location of the hearing; and (2) Hold a hearing and render a proposed decision to the Secretary in accordance with COMAR 28.02.01. E. After giving parties the opportunity to file exceptions and make oral arguments under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Secretary shall issue a final decision according to State Government Article, §10-221, Annotated Code of Maryland, and send notice of the decision to the: (1) Administration; (2) ASO; (3) Appropriate CSA; (4) Medical Assistance Program; and (5) Program director. F. Further Appeal. A program may appeal any final decision by the Secretary by following the provisions of Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. ### Chapter 17 — Community Mental Health Programs — Definitions and Administrative Requirements **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: January 2, 1995 (21:26 Md. R. 2187) **Administrative History:** Chapter revised effective October 5, 1998 (25:20 Md. R. 1530) **Administrative History:** Regulations .01 — .14 repealed and new Regulations .01 — .17 adopted effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .17 amended effective October 6, 2008 (35:20 Md. R. 1775) #### Regulation .01 Scope. *COMAR 10.21.17.01* This chapter delineates the administrative requirements for a community mental health program. #### Regulation .02 Definitions. *COMAR 10.21.17.02* A. In COMAR 10.21.16 and subsequent community mental health program chapters, the following terms have the meanings indicated. B. Terms Defined. (1) “Ability to pay” means the individual's ability to pay for mental health services, as determined according to the provisions of COMAR 10.04.02. (2) “Administration” means the Mental Hygiene Administration. (3) “Administrative services organization (ASO)” means the entity with which the Administration may contract to provide the services described in COMAR 10.09.70 for the public mental health system. (4) “Advance directive for mental health services” means a plan made by an individual pursuant to Health-General Article, §5-602.1, Annotated Code of Maryland. (5) “Aftercare plan” means the plan developed by inpatient facility staff according to the requirements of Health-General Article, §10-809, Annotated Code of Maryland and COMAR 10.21.05. (6) “Case coordination” means the process by which mental health and related support services to an individual are coordinated and monitored. (7) “Case resolution conference (CRC)” means an informal proceeding before an evidentiary hearing to determine if there are grounds for settlement of a contested case. (8) “Community support specialist” means the case manager as defined in COMAR 10.09.45. (9) “Contact note” means an entry that is made in an individual's medical record by a program staff member and that describes face-to-face, written, or telephone contact with or regarding the individual. (10) “Core service agency (CSA)” means the county or multicounty authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, to carry out the duties set forth therein. (11) “Credentialing” means the collection, verification, and assessment of information regarding four critical parameters: (a) Current licensure; (b) Relevant training; (c) Current competence; and (d) The ability to perform clinical responsibilities. (12) “Crisis intervention” means the therapeutic response that provides immediate care or referral for an individual with urgent mental health need. (13) “Day treatment program” means a program approved under COMAR 10.21.02 and is also referred to as partial hospitalization or psychiatric day treatment. (14) “Deemed status” means the Secretary's granting of approval under this subtitle to a program, based on the program's accreditation under the relevant behavioral healthcare standards of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) or Rehabilitation Accreditation Commission (CARF). (15) “Department” means the Maryland Department of Health. (16) “Designated emergency facility” means a health care facility identified under Health-General Article, §10-620, Annotated Code of Maryland, to perform the duties under Health-General Article, §10-624, Annotated Code of Maryland. (17) “Director” means the Director of the Mental Hygiene Administration. (18) “Discharge plan” means a brief description of the recommendations for continued treatment. (19) “Discharge summary” means a detailed review of services provided to an individual, including, at a minimum, the items outlined in Regulation .11C of this chapter. (20) “Enhanced support” means short-term, in-home services, in addition to other services to an individual, by a program that is approved by the Administration to provide this service, to support the individual to remain in the community. (21) “Enrolled” means the program's formal acceptance and admission of an individual into the program. (22) “Facility” has the meaning indicated in Health-General Article, §10-102(e), Annotated Code of Maryland, and may also be referred to as a site. (23) “Governing body” means the organizational structure that is responsible for all program operations, including: (a) Establishing policy; (b) Maintaining quality care; and (c) Providing management and planning for the program. (24) “Grievance” means an oral or written complaint filed by or on behalf of an individual regarding the denial of services based on eligibility or medical necessity criteria. (25) “Group home” means a private group home as defined in Health-General Article, §10-514, Annotated Code of Maryland, and licensed under COMAR 10.21.04. (26) “Guardian” means a guardian as defined in Estates and Trusts Article, §13-101, Annotated Code of Maryland. (27) “HIPAA” means part of the federal act outlined in 42 U.S.C. §1320D et seq., as amended, and the implementing regulations at 45 CFR Parts 160 and 164, as amended. (28) “Health officer” means the individual nominated by a county and appointed by the Secretary under the provision of Health-General Article, Title 3, Subtitle 3, Annotated Code of Maryland. (29) “Health promotion and training” means activities to increase an individual's awareness of physical and mental health status and of the resources required to help promote good physical and mental health. (30) “Independent living skills training” means activities to promote, maintain, or restore an individual's ability to perform essential activities of daily life. (31) “Individual” means: (a) An adult; (b) A person authorized to consent to health care for an adult; (c) A minor; (d) A minor who is 16 years old or older, if the medical care concerns treatment to which the minor has the right to consent, and if the minor has consented to treatment; (e) A parent; (f) A guardian; (g) The attorney of the minor; (h) The custodian of the minor; or (i) A representative of the minor designated by a court who can legally consent to treatment consistent with the authority granted. (32) “Individual rehabilitation plan (IRP)” means the plan prepared according to the requirements outlined in the chapter or chapters under this subtitle that delineate the requirements for the specific rehabilitation program. (33) Individual Treatment and Rehabilitation Plan (ITRP). (a) “ITRP” means the plan prepared according to the requirements outlined in the chapter or chapters under this subtitle that delineate the requirements for the specific program. (b) “ITRP” may substitute for a separate ITP and IRP. (34) “Individual Treatment Plan (ITP)” means the plan prepared according to the requirements outlined in the chapters under this subtitle that delineate the requirements for the specific program. (35) “Inpatient facility” means an inpatient institution that provides evaluation, treatment, and 24-hour residential care for individuals who have mental disorders. (36) “Lead CSA” means, for programs that provide services in multiple jurisdictions, the CSA identified by the Administration in collaboration with the appropriate CSAs to represent all involved jurisdictions. (37) “Managed intervention plan (MIP)”: (a) Means the plan that is developed, when appropriate, that details the strategies to be implemented in times of crisis to provide for a revised plan of services and supports to maintain the individual in a residential rehabilitation program residence, to prevent the unplanned discontinuation of services, or to prevent an inpatient admission; and (b) May be incorporated into the individual rehabilitation plan (IRP) or individual treatment and rehabilitation plan (ITRP). (38) “Maryland Medical Records Act” means the act outlined in Health-General Article, §4-301, Annotated Code of Maryland. (39) “Medical Assistance Program” means the Medical Assistance Program as defined in COMAR 10.09.36.01. (40) “Medicare” means the insurance program administered by the federal government under Title XVIII of the Social Security Act, 42 U.S.C. §1395 et seq., as amended. (41) Medication Monitoring. (a) “Medication monitoring” means: (i) Providing face-to-face assistance to an individual to achieve compliance with treatment with all prescribed psychiatric or somatic medications; and (ii) As needed, reviewing the individual's existing medication regimen with the appropriate physician. (b) “Medication monitoring” does not mean: (i) Prescribing medication; (ii) Measuring or pouring medicine; (iii) Preparation of a syringe for injection; or (iv) Administration of medication. (42) “Mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to provide the mental health service: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (43) “Mental health program (program)” means a community-based program that is approved by the Department under this subtitle to be eligible to receive State or federal funds, or both. (44) “Mental health vocational program (MHVP)” means a program approved under COMAR 10.21.28. (45) “Minor” means an individual who is younger than 18 years old. (46) “Mobile treatment services (MTS) program” means a program approved under COMAR 10.21.19. (47) “Nurse” means an individual who is licensed and legally authorized to practice as a nurse: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (48) “Occupational therapist” means an individual who is licensed and legally authorized to practice as an occupational therapist: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (49) “On-call” means the availability of designated program staff 24 hours per day, 7 days per week. (50) “Outpatient mental health center (OMHC)” means a program approved under COMAR 10.21.20. (51) “Physician” means an individual who is licensed and legally authorized to practice medicine: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (52) “Primary care provider (PCP)” means a practitioner who is the primary coordinator of care for the individual, whose responsibility it is to provide accessible, continuous, comprehensive, and coordinated health care services and includes PCPs covering the full range of benefits required by the Maryland Medicaid Managed Care Program, as specified in COMAR 10.09.67. (53) “Primary caretaker” means the minor's custodial parent or parents or the adult with whom the minor currently resides. (54) “Privileging” means the process by which a program determines that staff members are qualified to perform assigned duties. (55) “Professional counselor” means an individual who is certified or licensed and legally authorized to practice as a professional counselor: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (56) “Program director” means the individual who is responsible for the daily operations of a program, as outlined in the chapter under this subtitle that delineates the requirements for a specific program. (57) “Program improvement plan (PIP)” means a written statement from a program that documents the program's methods and time frames for correcting deficiencies cited by the Department's designated approval unit. (58) “Progress summary note” means an entry by an individual's program coordinator in the individual's medical record that summarizes the individual's progress toward goals delineated in the individual's ITP, IRP, or ITRP. (59) “Provisional diagnosis” means the diagnosis given as a result of an initial assessment of the symptoms at the first encounter with an individual that lasts only until the correct nature of the illness has been clarified by further clinical examination. (60) “Psychiatric rehabilitation program (PRP)” means a program approved under COMAR 10.21.21 for adults, and COMAR 10.21.29 for minors, or both. (61) “Psychiatrist” means a physician who: (a) Is certified in psychiatry by the American Board of Psychiatry and Neurology; or (b) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in psychiatry. (62) “Psychologist” means an individual who is licensed and legally authorized to practice as a psychologist: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (63) “Psychologist Associate” means an individual approved by the Board of Examiners of Psychologists for exemption to perform psychological services pursuant to Health Occupations Article, §18-301(b)(3), Annotated Code of Maryland, and COMAR 10.36.07. (64) Public Mental Health System (PMHS). (a) “Public mental health system” means the system for the delivery of mental health treatment and supports to individuals who meet medical necessity criteria and financial eligibility as established by the Maryland Department of Health Administration. (b) “Public mental health system” includes the specialty mental health system described in COMAR 10.09.70. (65) “Quality management (QM)” means the process by which a program maintains and improves the quality of services. (66) “Referral” means a contact made with a program by an individual, or on behalf of an individual, for mental health services. (67) “Rehabilitation coordinator” means the program staff person who is responsible for coordinating and providing rehabilitation services to an individual. (68) “Residence” means a housing unit leased or owned by an approved residential rehabilitation program (RRP). (69) “Residential checklist” means the form issued by the Department for the purpose of recording information gathered during the inspection of rehabilitation residences. (70) “Residential crisis services (RCS)” means services provided by a program approved under COMAR 10.21.26. (71) “Residential rehabilitation program (RRP)” means a program that is approved under COMAR 10.21.22. (72) “Residential specialist” means the individual designated by the Department or the CSA to inspect, monitor, and determine the approval status of a residence. (73) “Respite care services” means services provided by a program approved under COMAR 10.21.27. (74) “Secretary” means the Secretary of Health or the Secretary's designee. (75) “Serious emotional disturbance” means a condition that is: (a) Manifest in an individual younger than 18 years old; (b) Diagnosed according to a current diagnostic classification system that is recognized by the Secretary, excluding the following, unless they co-exist with a diagnosable psychiatric disorder: (i) Developmental disorders; (ii) Substance abuse; and (iii) Disorder classified under the “V” code; and (c) Characterized by a functional impairment that substantially interferes with or limits the minor's functioning in the family, school, or community. (76) “Serious mental illness” means a mental disorder that is: (a) Manifest in an individual 18 years old or older; (b) Diagnosed, according to a current diagnostic classification system that is recognized by the Secretary as: (i) Schizophrenic disorder; (ii) Major affective disorder; (iii) Other psychotic disorder; or (iv) Borderline or schizotypal personality disorder, with the exclusion of an abnormality that is manifested only by repeated criminal or otherwise antisocial conduct; and (c) Characterized by impaired functioning on a continuing or intermittent basis, for at least 2 years, and includes at least three of the following: (i) Inability to maintain independent employment; (ii) Social behavior that results in interventions by the mental health system; (iii) Inability, due to cognitive disorganization, to procure financial assistance to support living in the community; (iv) Severe inability to establish or maintain a personal support system; or (v) Need for assistance with basic living skills. (77) “Social skills training” means activities to diminish tendencies toward isolation and withdrawal by assisting individuals to acquire, maintain, or develop communication and other interpersonal skills. (78) “Social worker” means an individual who is licensed and legally authorized to practice as a social worker: (a) Under Health Occupations Article, Annotated Code of Maryland; or (b) In the state where the service is rendered. (79) “Supported housing” means activities to enable an individual to maintain housing of the individual's choice. (80) “Therapeutic group home (TGH)” means a program that is licensed under COMAR 10.21.04, 10.21.07, and COMAR 14.31.05, 14.31.06, and 14.31.07. (81) “Therapeutic milieu” means an environment that is clinically structured to provide mental health treatment in a place other than the individual's residence. (82) “Therapeutic nursery program (TNP)” means a program approved under COMAR 10.21.18. (83) “Treatment coordinator” means the licensed mental health professional who is responsible for coordinating and providing mental health services to an individual. (84) “Working day” means any day except Saturday, Sunday, or a holiday on which State offices are closed. #### Regulation .03 Authorization and Payment. *COMAR 10.21.17.03* A. Authorization for Services. (1) The program shall comply with the provisions of this regulation when the program provides services to: (a) A Medicaid recipient; or (b) An individual for whom, because of the severity of the mental illness and, based on the Administration's determination of the individual's ability to pay, the cost of care is subsidized, wholly or in part, through the public mental health system. (2) Before rendering services to an individual, a provider shall notify the Administration's administrative services organization (ASO), or for those services approved by the CSA, the CSA of the jurisdiction where the individual resides, as appropriate, and receive preauthorization for services, according to the provisions of COMAR 10.09.70.07. (3) When the Administration's ASO contacts a program directly to refer an individual, and the individual does not make an initial appointment or does not keep the initial appointment, program staff shall: (a) Attempt to reschedule an initial appointment for the individual; and (b) If that fails, notify the Administration's ASO that the individual has not received services. (4) Preauthorization is not required before a provider renders services in an emergency. (5) If a program discontinues admissions, the program director shall notify the CSA and the Administration's ASO, if appropriate. B. Payment for Services. (1) Fee Schedule. The Administration shall reimburse an eligible provider for rendering authorized services: (a) In accordance with the State budget; (b) According to the provisions of and at the rates established under COMAR 10.21.25; or (c) Pursuant to grants or contracts funded by the State or the CSAs. (2) If an individual is not a Medicaid recipient and, because of the severity of the individual's mental illness and financial need, the cost of the individual's care is subsidized wholly or in part with public funds, the provider shall: (a) Receive payment if the individual meets eligibility criteria established by the Administration; (b) Collect information from an individual to assess the individual's ability to pay, including information regarding any applicable insurance benefits; (c) Assess the individual's ability to pay and determine the required co-payment; and (d) Make collections of the co-payment according to the requirements in Health-General Article, §§16-201 — 16-204, Annotated Code of Maryland. (3) Medicare Recipients. (a) If a provider renders services to individuals who are Medicare recipients, the provider shall comply with all federal Medicare requirements. (b) If a provider does not comply with all Medicare requirements, the provider may not seek reimbursement by the PMHS. #### Regulation .04 Consent for Services, Orientation, and Advance Directive for Mental Health Services. *COMAR 10.21.17.04* A. Consent for Services. (1) Before initiating services to an individual, a program shall: (a) Obtain consent from the individual to: (i) Render services to the individual; and (ii) Involve, as appropriate, the appropriate CSA, the individual's family members, and others designated by the individual in the individual's service process; (b) Review with the individual: (i) That the program may disclose, without consent, certain protected health information, and obtain an acknowledgment from the individual of having received notice that such disclosure may occur; (ii) That the program may disclose, without consent, protected health information to other medical assistance programs and providers; and (iii) The requirements of the Health Insurance Portability and Accountability Act and the Maryland Medical Records Act, as to scope and limits of the confidentiality provisions; and (c) If the individual is a minor who cannot consent to services, obtain the appropriate consents and make the required disclosures. (2) If the individual agrees to consent to services but is unable or unwilling to give written consent, a program shall: (a) Document the reasons why the individual cannot give written consent; (b) Verify the individual's verbal consent to services; and (c) Periodically attempt to obtain written consent and document such efforts. B. Orientation. (1) On or before the date that an individual receives services, the program director shall ensure that an individual who has been admitted to the program receives information, verbally and in writing, including, but not limited to: (a) A description of the services available; (b) Individual rights and responsibilities; (c) Program hours and on-call procedures; (d) The program's procedures for discharge; (e) The program's procedures for confidentiality; (f) Crisis intervention services; and (g) The complaint and grievance processes. (2) The individual's program coordinator shall document in the individual's medical record the individual's receipt of the information contained in §B(1) of this regulation. C. Advance Directive for Mental Health Services. For individuals who are 16 years old or older, the program director shall: (1) Ensure that an individual who has been admitted to the program receives information, verbally and in writing, regarding making an advance directive for mental health services; (2) Document whether an individual has a current advance directive for mental health services; (3) If an individual has a mental health advance directive, include a copy of the document in the individual's medical record; and (4) If an individual requests assistance with making an advance directive for mental health services, assign staff to assist the individual. #### Regulation .05 Advisory Committee. *COMAR 10.21.17.05* A. Membership. A provider that is approved by the Department under this subtitle to operate a program shall have an advisory committee that is composed of members: (1) That reflect the cultural and ethnic profile of the community or communities being served; and (2) At least one-third of whom are individuals who identify themselves as being in one of the following categories: (a) Currently served or were previously served by a mental health program; (b) Family members of individuals who are currently served or were previously served by a mental health program; or (c) Members of a mental health advocacy organization. B. Responsibilities of the Advisory Committee. The advisory committee shall: (1) Establish and maintain a regular meeting schedule; (2) Maintain documentation of the meetings, including: (a) Date; (b) Members present; and (c) Summary of the topics discussed; (3) Review a program's: (a) Mission; (b) Long-range goals; (c) Policies and procedures; and (d) Services, hours, and location for consistency with community needs; (4) Advise the program director regarding the items outlined under §B(2) of this regulation; and (5) If applicable, annually review whether the program is satisfying its charitable mission. C. If a program has a governing body or board of directors, whichever applies, composed of the membership described under §A of this regulation, and the governing body or board of directors carries out the duties described under §B of this regulation, an additional advisory committee is not required. D. Limitation. In order for a program to be eligible to receive funds under this or any other chapter of the Administration's regulations, the following individuals may not serve on the governing body, board of directors, or advisory committee, whichever applies: (1) An immediate family member of an employee of a program; (2) A person who is compensated for providing goods and services to the program; and (3) A person who has served as a member of a governing body, board of directors, or advisory committee of a program that has had a license or approval revoked by the Department within the previous 10 years. #### Regulation .06 Collaboration with Core Service Agency (CSA). *COMAR 10.21.17.06* The program director shall: A. Submit annually to the CSA, or, when providing services in multiple jurisdictions, the lead CSA, and the Community Services Reimbursement Rate Commission, an annual summary that, at a minimum, includes: (1) Relevant financial statements or documentation and results of a financial audit; (2) Wage and benefit information for each job classification, including, but not limited to: (a) Administrative staff; (b) Supervisory staff; (c) Clinical staff; and (d) Direct care staff; (3) Other information deemed necessary by the Department and the Community Services Reimbursement Rate Commission; B. Collaborate with the CSA in the planning and development of services to be delivered in the CSA's jurisdiction; and C. Ensure that the program participates with the CSA's: (1) Protocol for resolution of conflict between the program and an individual served, or another program or agency, or both; and (2) Procedures for prevention of the appearance or occurrence of conflict of interest in the operation of the program's provision of mental health services. #### Regulation .07 Program Model. *COMAR 10.21.17.07* A. A community mental health program shall develop a program model that promotes recovery and resiliency as required according to the chapter under this subtitle for the specific program. B. The program director shall ensure that information and services are provided: (1) In a culturally sensitive manner; and (2) At a suitable reading comprehension level. #### Regulation .08 Records. *COMAR 10.21.17.08* A. General Requirements. (1) The program shall, either manually or electronically: (a) Establish a record for an individual who receives services from the program; and (b) Ensure that entries in the record are dated, signed, and include the signer's degree or license, or if the signer has no degree or license, the signer's staff position. (2) The program director shall ensure that individuals' program records are: (a) Maintained in a manner that is consistent with the medical records confidentiality and disclosure requirements of: (i) Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (ii) Relevant federal statutes and regulations, including the Health Insurance Portability Act, 42 U.S.C. §1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164; (b) Located so that the records are convenient and available to designated staff; (c) Managed by a designated staff member who is responsible for appropriate records control, including storage, security, and indexing of records; and (d) Subject to the requirements of confidentiality laws and regulations, are made available to the Department, the Administration's ASO, the CSA, and the Office of Inspector General, as necessary to carry out required activities. B. Contents of Record. When an individual is enrolled in a program, the program shall maintain a record of, at a minimum: (1) Identifying information, including but not limited to: (a) Name, sex, race, marital status, and date of birth of the individual; (b) Address and telephone number; and (c) As permitted by law, Social Security number; (2) Name, address, and telephone number of the individual to be contacted in case of emergency; (3) Dates of enrollment and initial service; (4) Source of referral; (5) If the individual has been referred upon discharge from an inpatient facility: (a) A copy of the aftercare plan and discharge summary; or (b) Documentation that the program has requested a copy of the aftercare plan and discharge summary; (6) If an individual has been court-ordered to receive evaluation or treatment, a copy of the court order; (7) Documentation of verification of the individual's financial information, or, if the individual is a minor, the minor's parent's financial information necessary to implement the Department's requirements on the setting of charges and collection of fees; (8) Presenting problem and history of the presenting problem, including, if known, precipitating factors and, if any, history of substance abuse; (9) Either, if indicated and relevant: (a) Copies of reports and recommendations of prior treatment, tests, and evaluations, including, when received, a report or summary of current physical examination; or (b) Documentation that the program has requested a copy of any reports and recommendations of prior treatment, tests, and evaluations; (10) For a minor who is enrolled in a program, copies of legal documents related to the minor's status, including but not limited to: (a) Court orders; and (b) Custody agreements; (11) For a minor who is enrolled in a program, an emergency contact form, which is up-to-date and which includes: (a) The name, address, and daytime telephone number of the primary caretaker; (b) The name, address, and telephone number of the primary care provider; and (c) If available, the names, addresses, and daytime telephone numbers of at least two individuals to be contacted in case of emergency when the primary caretaker cannot be reached; (12) The consent forms, signed by the individual or the individual's parent or guardian, as appropriate, for: (a) Participation in the program and activities provided by the program; and (b) Releasing information to or requesting information from other agencies, including the CSA, and health care providers; (13) Documentation of the clinical information as required in the chapter under this subtitle for specific program requirements; (14) If applicable, names and either addresses or telephone numbers of the individual's psychiatrist, therapist, case manager, primary care provider, managed care organization, and insurance carrier; and (15) The individual's discharge plan and summary. #### Regulation .09 Policies and Procedures. *COMAR 10.21.17.09* A. The program shall have and maintain written policies that, at a minimum include: (1) The program's mission and goals; (2) A description of the organizational structure of the program; (3) Identification of the duties of the program director and, if applicable, the medical director or clinical director; and (4) The policies and procedures for: (a) Ensuring individual rights, including confidentiality, and providing a complaint process; (b) Providing the services in the chapter under this subtitle that outlines the requirements for the specific program; (c) Screening, admission, transition, and discharge; (d) If the program provides case coordination, assisting program enrollees with access to all entitlements, pertinent resources, insurance benefits, and reimbursements for which the individual is eligible; (e) If applicable to the program, storing, handling, prescribing, administering, and disposing of medications; (f) If applicable to the program, monitoring of psychiatric and somatic medication; (g) If applicable, accounting for the use and expenditure of an individual's funds; (h) Staffing, including, if required under the chapter in this subtitle that outlines the provisions for the specific program, 24 hours, on-call and emergency coverage; (i) If the program provides services in a facility, a disaster and emergency evacuation plan; (j) According to federal and State requirements, safety precautions, infection control, and communicable disease control; (k) Incident reporting; (l) Crisis response plan; and (m) Information about any State and federal laws pertaining to civil or criminal penalties for false claims and statements and whistle blower protections, including the necessity for preventing and detecting fraud, waste, and abuse. B. At least every 3 years, appropriate program staff shall review and, as necessary, revise the policies and procedures. C. The program shall maintain written personnel policies, including, at a minimum: (1) Contents of an employee's personnel file, including, at a minimum: (a) Name; (b) Current job classification; (c) Current job description; (d) Resume containing educational background, relevant work experience, and specialized skills; (e) Copies of required certificates and licenses and primary source verification; (f) Documentation of a criminal background investigation as follows: (i) If the employee works with or has access to minors, a background investigation following the procedures set forth in Family Law Article, §§5-560 — 5-568, Annotated Code of Maryland; and (ii) If the employee works in a group home, a background investigation following the procedures set forth in Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland; (g) Information received from the employee's references; (h) Documentation of orientation, continuing education and training activities, and privileges granted; and (i) If the staff person's duties require transportation of staff or individuals served: (i) Proof of a valid driver's license issued in the state of the employee's residence; and (ii) Updated annually, a driver's license report from the appropriate state; (2) Staff orientation, supervision, training, and education; (3) Method of access to an employee's personnel file; (4) Substance abuse policy; (5) Ethical guidelines for employees; and (6) Confidentiality guidelines regarding disclosure requirements of: (a) Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and (b) Relevant federal statutes and regulations, including the Health Insurance Portability and Accountability Act, 42 U.S.C. §§1320D et seq., and implementing regulations at 45 CFR Parts 160 and 164. #### Regulation .10 Discharge from Services. *COMAR 10.21.17.10* A. When an individual has attained the goals identified in the individual's service plan, the individual's program coordinator shall begin the process for discharge planning. B. Discharge Policy. The program shall have and maintain written policies and procedures, which may be contained in one document, that include: (1) The process for all types of discharge from the program, including: (a) Collaborative discharge; (b) The individual's discontinuation of services; (c) The program's recommendation to discontinue services; and (d) The ASO's determination to discontinue authorization for services; and (2) The individual's right to appeal. C. Discharge Plan. (1) The individual's program coordinator and the individual, if appropriate, shall develop a discharge plan that: (a) Is based on an assessment of the individual's current status, service needs, and mutually agreed upon goal attainment; (b) Includes: (i) A brief description of the recommendations for continued treatment, if any; (ii) Referrals for continuing services; and (iii) Information about how the individual can re-access services when needed; and (c) With proper consent, is developed in collaboration with family or others designated by the individual, and other treatment, rehabilitation, and service providers. (2) The individual's program coordinator shall provide the individual with a copy of the discharge plan as soon as possible, but in no event, not later than the date of discharge. D. Discharge Summary. Within 10 working days after an individual is discharged from a program, a staff person responsible for coordinating services to the individual shall complete and sign a discharge summary that includes, at a minimum, the: (1) Reason for admission; (2) Reason for discharge; (3) Services provided, including the frequency and duration of services; (4) Progress that was made; (5) Diagnosis at the time of discharge, if appropriate; (6) Current medications, if any; (7) Continuing service recommendations and summary of the transition process; and (8) Extent of the individual's involvement in the discharge plan. E. Program's Recommendation to Discontinue Services. (1) If, in consultation with the program director, the program coordinator recommends discontinuing services for an individual for whom, because of the individual's actions, the program's services are not effective, or the individual's clinical needs exceed the program's ability to secure the safety and welfare of the individual or others, the program director shall provide written notice of the intention to discontinue services and recommend referral for alternative services. (2) Except in the case of imminent danger, the program director shall provide the notice at least 30 calendar days before discontinuing services. (3) The program director shall assure that the notice is sent to the individual and, with proper consent, to: (a) Family or others designated by the individual; and (b) If appropriate, the CSA and the Administration's ASO, for referral for alternative services. (4) The notice shall include: (a) The effective date of the action; (b) The reason for the action; and (c) A discharge plan. (5) If an individual presents as a danger to self or to others, the program director shall make necessary arrangements to try to protect the individual, others, or both, and link the individual with the appropriate level of care. F. ASO's Determination to Discontinue Authorization for Services. If the Administration's ASO determines that services are no longer medically necessary, the program coordinator shall follow the provision for discharge outlined in §C of this regulation. #### Regulation .11 Human Services Development. *COMAR 10.21.17.11* A. Supervision. The program director shall: (1) Establish a system to ensure ongoing supervision of staff; and (2) Determine the need for staff supervision on the basis of: (a) Credentials, competencies, experience, education, and training; (b) Performance standards and outcome measures identified by the quality management process; (c) Size of caseload; and (d) Severity of illness of individuals enrolled in the program. B. Orientation. The program director shall assure that staff: (1) Within the first week of employment, receive an orientation regarding the: (a) Mission of the program; (b) Fundamental rights of the individuals the program serves, including grievance, complaint, and confidentiality procedures of the program; (c) Psychiatric and medical emergency procedures of the program, including crisis management and suicide prevention; and (d) If the program provides services in a facility, emergency evacuation procedures; and (2) Within 2 months, receive orientation including, but not limited to, the following: (a) Program policies and procedures; (b) Personnel policies and procedures; and (c) Overview of the public mental health services delivery system. C. Continuing Education. The program director shall assure that staff who provide direct services to individuals participate in at least 8 hours of annual educational activities related to the provision of the program's services. D. CPR and First Aid. The program director shall ensure that at least one staff member with certification in cardiopulmonary resuscitation (CPR) and standard first aid is on-site during the hours the program is open. E. Students. A program may use students to provide services to individuals only if the students: (1) Are pursuing degrees at accredited colleges or universities toward state licensure as mental health professionals; (2) Deliver services as part of formal fieldwork placements through accredited colleges and universities; (3) Comply with their respective professional licensing laws, including supervision requirements, as outlined in Health Occupations Article, Annotated Code of Maryland; and (4) Are appropriately screened, oriented to the program's policies and procedures, and supervised. F. Volunteers. (1) A program may use volunteers to assist with program activities only if the: (a) Volunteers are at least 16 years old, and with proper consent, if applicable; (b) Volunteers are appropriately screened, oriented to the program's policies and procedures, and supervised; and (c) Program has a written policy regarding the scope of the volunteers' duties. (2) A volunteer may not substitute for required program staff. #### Regulation .12 Quality Management (QM). *COMAR 10.21.17.12* A. A program shall establish and maintain a QM process in accordance with the requirements of this regulation. B. QM Plan. The program director shall develop and, at least every 3 years, review a written QM plan that: (1) Provides for an internal, ongoing quality performance evaluation process that describes the: (a) Program goals; and (b) Mechanisms, including staff responsible and resources available, for implementing the QM process; (2) Is oriented to the individuals served and emphasizes recovery, collaboration, continuity of care, accessibility, accountability, and efficiency; (3) Includes a system to evaluate: (a) Quality of care and services rendered to individuals; (b) Staff performance in the provision of the services; (c) Staff competencies; and (d) Appropriateness of the program's: (i) Services, including accessibility and hours of operation; (ii) Staff; and (iii) If the program provides services in a facility, physical plant, and environment; (4) Includes a process for the adequate collection of data in order to identify problems; and (5) In order for staff to implement actions to correct deviations from the program's established standards, identifies a plan that: (a) Is based on: (i) The data collected under §B(4) of this regulation; (ii) Input from staff and individuals served; (iii) A review of the program's outcomes; and (iv) Current trends in efficient and effective treatment and services; (b) Is consistent with the program model and the specialized needs of those served; and (c) Provides for ongoing internal review of the program, including monitoring for effectiveness of changes incorporated. C. Risk Management (RM). The program director shall develop and, at least every 3 years, review a written RM plan, which may be a component of the QM plan, that: (1) Includes policies and procedures for critical incidents, including: (a) Suicides; and (b) Unfavorable service-related outcomes, including discharges that are not mutually agreed upon; (2) Includes a mechanism by which the program director reports: (a) An allegation of mental, physical, or sexual abuse or neglect of an individual, as provided under Health-General Article, §10-705, and Family Law Article, Title 5, Subtitle 7, and Title 14, Annotated Code of Maryland; and (b) The death of an individual, as outlined in Regulation .13 of this chapter; and (3) Tracks and evaluates incidents reported under §C(1) and (2) of this regulation and complaints filed under Regulation .16 of this chapter to determine trends. D. Program Service Outcomes. The program director shall: (1) Comply with the outcome reporting requirements as determined by the Administration; (2) Report data when required and as specified by the Administration; (3) Conduct and analyze the results of an annual satisfaction survey of the program's consumers; (4) Develop a process to inform the individuals served of the program's service outcomes; and (5) Make programmatic changes as appropriate. #### Regulation .13 Reports of Death. *COMAR 10.21.17.13* Upon notification of the death of any individual in a State funded or operated program or facility, the administrative head of the program or facility shall: A. Report the death according to the provisions of Health-General Article, §10-714(a), Annotated Code of Maryland; and B. Use the form required by the Administration. #### Regulation .14 Staff Credentials, Competencies, and Privileges. *COMAR 10.21.17.14* A. The program director shall ensure that staff and consultants perform only those duties for which the staff and consultants have the appropriate credentials and competencies according to the provisions of this regulation. B. Staff Credentials. The program director shall ensure that the program has in effect a process for reviewing credentials that requires the program to collect, verify, review, and document the following information: (1) Education; (2) If required, primary source verification of licenses or certification under Health Occupations Article, Annotated Code of Maryland, to practice a health occupation; and (3) Documentation of professional liability insurance that is carried either individually or through the program. C. Staff Competencies. The program director, in consultation, if appropriate, with the medical director, clinical director, or program psychiatrist, shall develop and implement: (1) A process by which the program reviews and evaluates: (a) Education, credentials, and additional training; (b) Relevant work experience, including experience with populations served by the program, including but not limited to: (i) Adults with serious and persistent mental illness; (ii) Children and adolescents with serious emotional disturbance; and (iii) Elderly individuals with mental illness; and (c) Competencies required to perform the services rendered; (2) A system to grant, deny, suspend, or revoke privileges to perform specific services; and (3) Methods for periodic review of credentials and competencies. D. Staff Criminal Conduct. (1) If a staff member is charged with a crime that involves abuse of an individual, or individuals served by the program, the governing body, board of directors, or advisory committee, whichever applies, shall have a process to determine, without the participation of the staff member in interest, whether the staff member can continue to provide services. (2) If the governing body, board of directors, or advisory committee, whichever applies, determines that the staff member may continue to provide services, the governing body, board of directors, or advisory committee, whichever applies, shall determine the capacity in which the staff member may continue to provide services until the charges are resolved. #### Regulation .15 Rights. *COMAR 10.21.17.15* A. A program shall: (1) Explain to an individual enrolled in a program the individual's rights as set forth in Health-General Article, Title 10, Subtitle 7, and Title 4, Subtitle 3, Annotated Code of Maryland; (2) Provide, in writing, information regarding an individual's rights as outlined in §A of this regulation to an individual enrolled in a program; and (3) Prominently display, in accessible centralized locations, the individual's rights as outlined in §A of this regulation. B. A program may not use restraints or seclusion. #### Regulation .16 Complaints. *COMAR 10.21.17.16* A. A program shall develop and implement an internal process for the prompt and objective resolution of complaints related to services provided that may be presented by an individual. B. The program shall prominently display, in accessible centralized locations, the written description of the complaint process. C. A program shall: (1) Prepare the document describing the program's complaint process; (2) Include as part of the written complaint process a form for the individual's use when filing a complaint, and a process by which, if requested by the individual, a program staff member or individual chosen by the individual receiving services, can assist in its completion; and (3) Provide a copy of the program's complaint process for each individual: (a) During the individual's orientation; and (b) At any time upon an individual's request. D. A program shall include in the complaint process required by §A of this regulation the procedures for registering and responding to the complaints in a timely fashion, which: (1) Require a complaint to be reviewed by the program and, if applicable, the CSA, within 30 calendar days of the program's receipt of the complaint; (2) Allow participation by others designated by the individual; (3) Allow information to be presented to support the individual's position; (4) Ensure the participation of the program staff members who have the authority to implement corrective action; (5) Require documentation of the substance of the complaints and the actions taken; (6) Include a review which: (a) Provides an opportunity, if the individual chooses, to have the individual's complaint reviewed by the CSA director or the CSA director's designee; (b) Requires the program, before making a final determination, to collaborate with the CSA to address the individual's complaint; and (7) Include written notification of the program's determination to: (a) The individual who filed the complaint; and (b) If the program's final determination conflicts with the CSA's opinion, the Administration. E. If the program's final determination conflicts with the CSA's opinion, the Administration may review the complaint as indicated. F. Unless the individual presents a serious risk to self or others, the program shall postpone taking action until the recommendations of the CSA and the Administration have been made, if applicable. #### Regulation .17 Grievances. *COMAR 10.21.17.17* If an individual has a grievance regarding the denial of services based on eligibility or medical necessity criteria, the individual may file the grievance according to the procedures outlined in COMAR 10.09.70.08. ### Chapter 18 — Community Mental Health Programs — Therapeutic Nursery Programs **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: January 2, 1995 (21:26 Md. R. 2187) #### Regulation .01 Scope. *COMAR 10.21.18.01* A. This chapter applies to clinical programs that provide a combination of developmental and mental health services in a preschool setting, made accessible and available to children and the families of children who are at risk for or who are emotionally disturbed, who have behavior or adjustment problems, or both. B. The Department shall grant approval to an agency to be eligible to receive State funds for providing therapeutic nursery services if the agency meets the requirements of this chapter and COMAR 10.21.16, 10.21.17, and 07.04.02. #### Regulation .02 Definitions. *COMAR 10.21.18.02* A. In this chapter, terms have the meanings stated in COMAR 10.21.17 and this regulation. B. Terms Defined. (1) “Individualized family service plan (IFSP)” means the plan defined in COMAR 10.09.40. (2) “Learning center” means a designated area of a classroom that serves children in a therapeutic nursery and that is equipped specifically for the development of a particular skill, including, but not limited to, fine motor, gross motor, and socialization. (3) “Primary caretaker” means the child's custodial parent or parents, or the adult with whom the child currently resides. (4) “Program A” means a therapeutic nursery that provides services to children who are younger than 3 years old and whose primary caretakers are present on the site of the therapeutic nursery to participate in the treatment process with the child. (5) “Program B” means a therapeutic nursery that provides services to children who are 3 years old or older, and younger than 5 years old. #### Regulation .03 Program Model. *COMAR 10.21.18.03* A provider of therapeutic nursery services shall ensure that services: A. Are appropriate to the cultural and psychosocial developmental needs of the child; B. Are provided: (1) For a minimum of 3 hours per day, 3 days per week at each site; and (2) In either a free-standing program or as an integral component of a preschool program in which services are offered in a therapeutic milieu; C. Are provided by staff who: (1) As determined by the program, are appropriately credentialed and privileged; and (2) Organize and manage the milieu to: (a) Foster clinically appropriate social, intellectual, emotional, and physical growth; (b) Handle aggression in a nonpunitive manner that promotes growth and learning; (c) Reinforce the child's ability to function with peers in a social environment; (d) Model and provide opportunities for children to behave in age-appropriate ways, such as: (i) Being playful; (ii) Assuming responsibility for carrying out routine activities; (iii) Exhibiting independence and initiative in planning their own learning; (iv) Getting along with others; and (v) Being courteous; (e) Facilitate the child's awareness of appropriate behavior in a predictable, constructive, and timely manner; and (f) Help children to make choices and to negotiate disagreements among themselves, rather than resolving conflicts for them; D. Are provided in an environment that: (1) Is consistent with existent standards of program design; (2) Is organized so that the child can function in an environment with a minimum of adult direction; (3) Has space that facilitates the activities of each learning center allocated to each center; (4) Has sufficient space and separation between learning centers so that children can engage in activities of their choice without distracting or being distracted by others; (5) Provides materials that are available for children's use and are otherwise appropriately stored; and (6) Displays exhibits of children's work that reflect children's current experiences, developmental level, diversity, and individuality; E. Are designed to develop or improve the ability of the primary caretaker to care for the child; and F. Maintain linkage with schools and preschool programs to effect transition at the appropriate time and with the necessary support services. #### Regulation .04 Referral and Admission. *COMAR 10.21.18.04* A. Referral. A therapeutic nursery may accept a referral to the therapeutic nursery from: (1) Education, social service, or health care agency staff; (2) Family members; or (3) Other interested individuals and agencies. B. Eligibility. A child is eligible for therapeutic nursery services if the child: (1) Has or is at risk for a mild to severe mental disorder, as defined in the current Diagnostic and Statistical Manual of Mental Disorders, or mild to severe behavioral problems, or both; (2) Is at risk for emotional or behavioral problems because the child: (a) Is experiencing substantial developmental delay or atypical development which, if left untreated, is likely to impair severely the child's ability to function independently, as measured by diagnostic instruments and procedures that meet usual and customary practice standards, in one or more of the following areas: (i) Cognitive development; (ii) Physical development; (iii) Language and speech development; (iv) Psychosocial development; or (v) Self-help skills; (b) Has experienced psychological trauma, as identified by an evaluation by a mental health professional; (c) Has a diagnosed physical or mental condition which has a high probability of resulting in developmental delay; or (d) Has been excluded, for developmental or behavioral problems, from more than one preschool or day care program; (3) Is at risk for emotional or behavioral problems and is a child who is being assessed or has been assessed in a suspected child abuse or neglect investigation pursuant to Family Law Article, §5-701 et seq., Annotated Code of Maryland; or (4) Is at risk for emotional or behavioral problems because of significant family history, as identified by an evaluation by a mental health professional. C. Admission. (1) A therapeutic nursery program may admit a child: (a) If the child is: (i) For Program A, younger than 3 years old, and the primary caretaker is available to participate in the treatment process; or (ii) For Program B, 3 years old or older, but younger than 5 years old; (b) Upon the written or tape-recorded consent of the child's parent or guardian; and (c) For whom a physician orders therapeutic nursery services as medically necessary. (2) A therapeutic nursery program may not admit a child: (a) Whose primary or sole diagnosis or condition is: (i) Mental retardation; (ii) Visual impairment; (iii) Hearing impairment; (iv) Physical disorder; or (v) Technology dependence; or (b) Who has cognitive deficits that severely limit the ability to benefit from the treatment modalities provided by the therapeutic nursery. #### Regulation .05 Evaluative Services for the Child. *COMAR 10.21.18.05* A. Assessment. If a comprehensive developmental assessment has not been completed within the 90 days before admission, before the child's 6th visit, the therapeutic nursery staff shall assure the completion of an assessment, including, when appropriate, standardized measurement, that includes, at a minimum, an assessment of the following: (1) Social and emotional development; (2) Cognitive skills and deficits; (3) Language development; (4) Motor skills, fine and gross; (5) Self-help and adaptive skills; (6) Family history and evaluation; (7) Home environment; (8) Developmental history; (9) Mental status; and (10) Medical history and needs, if any. B. Diagnosis. Before the child's 6th visit, an individual qualified to diagnose under the provisions of Health Occupations Article, Annotated Code of Maryland, shall: (1) Conduct a face-to-face evaluation of the child; (2) Formulate and document a diagnosis; and (3) Document the rationale for the diagnosis. C. Individual Treatment Plan (ITP). (1) Treatment Team. At a minimum, the following individuals shall participate on a child's treatment team: (a) At least one of the following: (i) The therapeutic nursery physician; or (ii) A staff psychologist or psychologist consultant; (b) At least one other mental health professional; (c) All therapeutic nursery staff who are involved in providing services to the child and family; and (d) If the therapeutic nursery is affiliated with an educational preschool program, the educational staff, as determined appropriate by the therapeutic nursery clinical director. (2) Plan. Before the child's 6th visit, the therapeutic nursery treatment team, working cooperatively with the child's primary caretaker and classroom teacher, shall prepare an ITP that includes: (a) The diagnostic formulation, as required by §B of this regulation; (b) A description of the child's behavior that includes: (i) Problem list; and (ii) Asset list; (c) Goals and objectives stated in behavioral, measurable terms; (d) Treatment strategies; (e) Classroom interventions; (f) Home interventions; (g) For children in Program A, that portion of an IFSP, if any, that pertains to therapeutic nursery services; and (h) As relevant, the information about the following from the child's parent, guardian, or primary caretaker, in consultation with appropriate health care or other service providers: (i) Instructions for care in an emergency; (ii) History of allergies, including to medication; (iii) History of seizures; (iv) Medication prescribed; (v) Nutritional requirements, limitations, and feeding procedures; and (vi) Essential medical or nonmedical treatments or procedures, including any advanced directives. (3) Signatures on the ITP. The following shall sign the ITP: (a) The treatment coordinator of the therapeutic nursery; (b) The therapeutic nursery physician, staff psychologist, or psychologist consultant; (c) If the child is receiving medication, the therapeutic nursery physician; (d) If the individual who signs under the provisions of §C(3)(b) of this regulation is also the treatment coordinator, at least one other mental health professional; and (e) Following review of the ITP, the parent, guardian, or primary caretaker. (4) 45-Day Review. At a minimum of every 45 days: (a) The treatment coordinator shall: (i) Review the progress on the ITP; (ii) Document in the child's record a description of progress toward goals and changes in goals and interventions based on the review of progress under §C(4)(a)(i) of this regulation; and (iii) Update the ITP accordingly; and (b) A minimum of two treating mental health professionals shall sign the 45-day review. (5) 3-Month Review. Every 3 months, at a treatment team meeting, the: (a) Treatment team shall review the ITP according to the process outlined in §C(4) of this regulation; (b) Treatment coordinator shall update and sign the 3-month review; and (c) Therapeutic nursery physician, staff psychologist, or psychologist consultant shall sign the ITP review. D. Continuing Evaluation. In order to ensure that services to a child are timely and appropriate, therapeutic nursery staff shall document in the child's record: (1) As outlined in the policy and procedures manual, contact notes regarding all clinically relevant face-to-face, telephone, and written contacts with or about the child, including the dates, locations, and types of contacts; and (2) Progress summary notes, entered at least monthly, by staff members involved in the child's treatment and classroom activities, regarding progress toward treatment goals. #### Regulation .06 Treatment and Support Services. *COMAR 10.21.18.06* A. Therapies. The therapeutic nursery program shall provide the following therapies: (1) If required by the ITP, individual therapy: (a) With the therapeutic nursery mental health professional staff; (b) With the community psychotherapist who is currently treating the child; or (c) By referral; (2) For children in Program A, conjoint therapy involving an individual child or groups of children with their primary caretakers; (3) Milieu therapy that uses the environment as a tool to assist the child, in keeping with routine developmental expectations, to manage behavior and function appropriately and cooperatively with peers and adults. B. Daily Activities. The therapeutic nursery program shall implement, on a consistent, regular basis, a plan for daily activities that: (1) Incorporate a variety of experiences with language, music, art, science, dramatic play, block play, and equipment and materials that promote large and small muscle development; (2) Allow for self-selected and planned as well as individual and small group activities; and (3) Include safe, regular, and developmentally appropriate outdoor play, with supervision consistent with the staff-to-child ratio required under Regulation .08D of this chapter. C. Services for Families. The therapeutic nursery program shall provide services to families, including but not limited to: (1) As indicated by the ITP, counseling or therapy: (a) With the therapeutic nursery mental health professional staff; (b) With the community psychotherapist who is currently treating the child; or (c) By referral; (2) Orientation for parents, guardians, or primary caretakers to the specialized treatment interventions that are designed to facilitate the child's continued development; (3) Mental health support groups; and (4) Therapeutic home visits. D. Interagency Consultation and Referral. (1) Services to Center. If the therapeutic nursery is included within another early childhood program, the therapeutic nursery staff shall provide those services to the early childhood program that the therapeutic nursery staff determine to be appropriate, including, but not limited to: (a) Staff development and training; (b) Mental health consultation regarding specific clinical interventions to be used in relating to therapeutic nursery children; (c) Classroom consultation, including observation and feedback; and (d) When necessary, psychoeducational strategic consultation. (2) Referral Services. For those services indicated in a child's ITP and not provided by the therapeutic nursery staff, the program shall have a policy and procedure for referral for: (a) Therapy, pursuant to §§A(1)(c) and C(1)(c) of this regulation; and (b) Evaluative or support services, including but not limited to: (i) Speech and language; (ii) Vision and hearing; (iii) Special instruction, special education, or other early intervention; (iv) Somatic care; (v) Occupational therapy assessment and treatment; and (vi) Psychological testing. #### Regulation .07 Discharge and Transitioning. *COMAR 10.21.18.07* A. Not later than the date of admission, the therapeutic nursery program shall provide a written policy statement on discharge and transition procedures to parents, legal guardians, and primary caretakers. B. To the extent practicable, parents, legal guardians, or primary caretakers as well as referring agencies or professionals, and the continuing care providers shall participate in discharge and transition planning. C. Within 15 days of discharge, the therapeutic nursery staff shall complete a discharge summary in accordance with the provisions of COMAR 10.21.17.07D(3). D. With the consent of a parent or legal guardian as necessary, the therapeutic nursery program shall forward a copy of the discharge summary to the continuing care provider. E. Criteria for discharge include but are not limited to: (1) Symptomatic alleviation; (2) Achievement of treatment goals; (3) Readiness for participation in off-site educational programs; or (4) Inability of the enrollee or the primary caretaker, or both, to comply with program requirements. #### Regulation .08 Program Staff. *COMAR 10.21.18.08* A. Based on the complexity of the services provided and the number of enrollees in the therapeutic nursery, a therapeutic nursery program shall provide sufficient staff to maintain the staff-to-child ratio provided in §E of this regulation and to carry out the therapeutic goals of the therapeutic nursery. B. Therapeutic Nursery Staff. A provider of therapeutic nursery services shall ensure that the therapeutic nursery staff includes, at a minimum: (1) A program director who: (a) Is a mental health professional or has a master's degree in a health services administration field; (b) Is on a site of the therapeutic nursery at least 50 percent of the operating hours of the therapeutic nursery program; (c) If a therapeutic nursery program operates in more than one site, has contact with each site each week; and (d) Is responsible for operational oversight for, at a minimum: (i) Fulfilling the administrative requirements under COMAR 10.21.17; (ii) Recruiting, hiring, and providing administrative supervision of staff; (iii) Developing and implementing the budget; (iv) Keeping the governing body informed of, at a minimum, the program's approval status and performance; and (v) Recruiting and enrolling program participants; (2) A clinical director who: (a) Is a mental health professional; (b) Is on a site of the therapeutic nursery at least 50 percent of the operating hours of the therapeutic nursery program; (c) If a therapeutic nursery program operates in more than one site, has contact with each site each week; (d) If the clinical director is also the program director, is on a site at the therapeutic nursery program on a full-time basis during the operating hours of the therapeutic nursery program; and (e) Is responsible for oversight for, at a minimum, the following: (i) Development of the ITP; (ii) Providing clinical supervision of staff, including the educational staff of a therapeutic nursery program that is not affiliated with an educational preschool program; (iii) Development of therapeutic strategies that may be used in the classroom; (iv) Development of treatment programs; (v) Quality improvement; and (vi) Inservice training; (3) A therapeutic nursery physician who: (a) Has completed a residency in child psychiatry in an accredited program; (b) As specified in the employment or consultant contract, is available on a therapeutic nursery site for the amount of time necessary to carry out the duties outlined in §B(3)(c) of this regulation, and, at a minimum: (i) If 25 or fewer children are enrolled in the therapeutic nursery program, for a minimum of 2 hours per week; and (ii) For 1 additional hour per week for every additional one to ten children who are enrolled in the therapeutic nursery program; and (c) Is responsible for, at a minimum, the following: (i) Establishing and maintaining appropriate standards for treatment, including therapeutic modalities and prescribing practices; (ii) Unless carried out by other staff qualified under the provisions of Health Occupations Article, Annotated Code of Maryland, as required under the provisions of Regulation .05B and C of this chapter, diagnostic formulation and participation in the development and signing of the ITP and the ITP 3-month reviews; (iii) Clinical supervision of those cases requiring face-to-face medical review; (iv) Review of medication utilization and corrective feedback when utilization is found to be inappropriate; and (v) Medical aspects of quality improvement; and (4) A staff psychologist or psychologist consultant who: (a) As specified in the employment or consultant contract, is available on the site or sites of the therapeutic nursery program for the amount of time necessary to carry out the duties outlined in §B(4)(b) of this regulation; and (b) Is responsible for, at a minimum, the following: (i) Unless carried out by other staff qualified under the provisions of Health Occupations Article, Annotated Code of Maryland, as required under the provisions of Regulation .05B and C of this chapter, diagnostic formulation and participation in the development and signing of the ITP and the ITP 3-month reviews; (ii) As needed, performing psychological assessment and testing; and (iii) Making appropriate referral for those cases requiring face-to-face medical review. C. Treatment Coordinator. The program director shall assign to each child who is admitted to a therapeutic nursery a treatment coordinator who is a mental health professional. D. Educational Staff. If the therapeutic nursery is not affiliated with an educational preschool program, the therapeutic nursery educational staff shall: (1) Be sufficient to carry out the educational programs provided by the therapeutic nursery and the classroom strategies described in the ITPs; and (2) Meet the qualifications required under COMAR 13A.09.09.05C. E. Staff-to-Child Ratio. The therapeutic nursery program shall ensure that the following required treatment or education staff-to-child ratio is maintained at all times: (1) For Program A, a staff-to-child ratio of at least one staff member for every five enrollees; and (2) For Program B: (a) If the therapeutic nursery is not affiliated with an educational preschool program, a staff-to-child ratio of at least one staff member for every four enrollees; and (b) If the therapeutic nursery is affiliated with an educational preschool program, a staff-to-child ratio of at least one therapeutic nursery treatment staff member for every 10 preschool children, provided that not more than four children are therapeutic nursery enrollees. #### Regulation .09 Policies and Procedures. *COMAR 10.21.18.09* In addition to the policy and procedure requirements outlined in COMAR 10.21.17.08, a therapeutic nursery program shall adopt policies and procedures for: A. Licensure by the Department of Human Services under COMAR 07.04.02; B. Physical setting, furnishings, materials, and equipment, as required by Regulations .10 and .11 of this chapter; C. Health and safety, as required by Regulation .12 of this chapter; and D. Transportation, as required by Regulation .13 of this chapter. #### Regulation .10 Physical Setting. *COMAR 10.21.18.10* A. Capacity. (1) The Department shall determine the capacity of a therapeutic nursery based on: (a) Space requirements under §C(1) of this regulation; (b) Staff requirements, including the staff-to-child ratio, required under Regulation .08D of this chapter; and (c) Maintenance of the therapeutic milieu described in Regulation .03B(2) of this chapter. (2) The program director of the therapeutic nursery program shall limit the number of enrollees to the capacity applied for and approved by the Department. B. Requirements for the Building. The therapeutic nursery program shall operate the program in a building that conforms to the applicable federal, State, and local laws and regulations, including but not limited to: (1) Zoning; (2) Sanitation; (3) Fire and safety codes; and (4) The requirements of the Americans with Disabilities Act. C. Indoor Space. The therapeutic nursery program shall: (1) For each child enrolled in the therapeutic nursery, provide a minimum of 35 square feet of floor space, not including spaces, such as vestibules and corridors, food preparation areas, bathrooms, adult work areas, and storage spaces, that are not available for the daily program activities of the children; and (2) Provide suitable space for individual, family, group, and play therapies. D. Outdoor Space. The therapeutic nursery program shall ensure compliance with applicable State and local laws and regulations for outdoor space, including but not limited to water safety requirements. #### Regulation .11 Materials, Equipment, Furnishings, and Storage. *COMAR 10.21.18.11* A. Materials and Equipment. In addition to any other requirements of law or regulation, the therapeutic nursery program shall: (1) Provide a sufficient quantity and variety of materials and equipment for indoor and outdoor activities, according to the numbers and ages of the children enrolled, including materials and equipment for: (a) Vigorous play; (b) Creative or dramatic play; (c) Socialization; (d) Manipulation, including construction, exploration of art, music, language arts, and science; and (e) Individual pursuits; (2) Store materials and equipment so that they are accessible to a child at the appropriate time; and (3) Ensure that the materials and equipment used by children in the therapeutic nursery are: (a) Safe; (b) Clean; (c) Nontoxic; (d) Free from hazards, including lead paint; (e) In good repair; and (f) Age appropriate. B. Furnishings. In addition to any other requirements of law or regulation, the therapeutic nursery program shall provide: (1) Furnishings that are proportional to a child's size; and (2) At least the following: (a) Multipurpose tables and chairs; and (b) A suitable crib, bed, cot, or mat and clean bedding for each child who requires a rest period during the hours of operation of the therapeutic nursery. C. Storage. In addition to any other requirements of law or regulation, the therapeutic nursery program shall: (1) Provide storage for: (a) Materials and equipment that are for a child's use; (b) Portable equipment intended for outdoor use; (c) Beds and bedding when they are not in use; (d) Each child's clothing and possessions in a space designated for each child; and (e) Materials, equipment, furnishings, and supplies being held in reserve; and (2) Ensure that all potentially hazardous items, including knives, tools, poisonous and toxic materials, prescription and nonprescription medicines, cleaning materials, and matches, are stored: (a) In a safe manner; (b) When applicable, in original containers; and (c) Out of the reach of children. #### Regulation .12 Health and Safety Requirements. *COMAR 10.21.18.12* The therapeutic nursery program director shall: A. Ensure that a criminal background investigation as required under Family Law Article, §§5-560 — 5-568, Annotated Code of Maryland, has been completed and is on file in each staff member's personnel record; B. If a child is involved in an accident or is injured while in attendance at a therapeutic nursery program: (1) Notify the primary caretaker on the day that the accident or injury occurs; (2) If the injury is serious, notify the parent or guardian immediately; (3) Ensure that appropriate treatment is provided; and (4) Document the incident according to the requirements of the risk management policy of the therapeutic nursery; C. At all times that children are participating in the therapeutic nursery program, ensure that staff are present who hold current certificates indicating approved training in: (1) Infant and child cardiopulmonary resuscitation (CPR); (2) First aid; and (3) If wading or swimming are therapeutic nursery activities, Red Cross water safety; D. Prepare an emergency evacuation plan that: (1) Is approved by the local fire authority; (2) Is posted in each room of the therapeutic nursery; (3) The staff and children practice at least monthly, and the staff maintain a written record of the dates and times of the practices; and (4) Includes: (a) Safe routes by which the staff and children may exit each area in the event of fire or other emergency requiring evacuation of the building; (b) The address of a location that can be used by the staff and children in the event of fire or other emergency until the parents, guardians, or primary caretakers of the children are notified; and (c) The provisions that, during an evacuation or a practice, a designated staff member take out of the building the record of attendance for that date and verify the presence of each child in attendance; E. Provide telephones that are accessible to the staff in each activity area in the therapeutic nursery, and post the following information next to each telephone: (1) 911 telephone number to summon fire, police, and rescue services; (2) The name, address, and telephone number of the therapeutic nursery; (3) Telephone number of the child protective services unit of the local department of social services; and (4) Telephone number of a poison control center; F. Release a child: (1) Only to the child's parent, guardian, or primary caretaker; or (2) If so directed by the child's parent, guardian, or primary caretaker, to another individual whose identity is verified; G. As required by COMAR 10.06.01: (1) Report communicable diseases; and (2) Restrict attendance by staff and children with communicable diseases; H. Not permit anyone to use alcohol or controlled dangerous substances on the premises or to smoke cigarettes, cigars, or pipes in rooms or areas approved for use by a child; I. Implement measures to prevent the spread of disease including requiring that staff wash hands and ensure that a child's hands are washed thoroughly with soap and water after toileting, before handling food, after outdoor activities, and at other times necessary to prevent the spread of disease; J. Provide for general cleanliness by ensuring that: (1) All surfaces, furnishings, materials, and equipment are clean; (2) Except for emergencies and clean-up activities that are part of the daily program, cleaning is not conducted while rooms are occupied by children; (3) Refuse containers in the building are: (a) Noncombustible; and (b) If they contain soiled diapers, lined with a disposable liner, covered with a lid, and inaccessible to children; and (4) Refuse containers outside the building meet the standards required by local code; and K. Provide written notification to each staff member and documentation that each staff member has read and understood the notification regarding: (1) The location of the telephone and the emergency telephone numbers specified in §E of this regulation; (2) The location of each child's emergency form; (3) Emergency evacuation procedures; (4) Identity of the staff members who have appropriate first aid, CPR, and Red Cross water safety training; (5) Signs and symptoms of abuse and neglect; (6) The requirements and procedures for reporting suspected child: (a) Abuse directly to the local department of social services or law enforcement agency; and (b) Neglect directly to the local department of social services; (7) Risk management; and (8) The contents of this chapter. #### Regulation .13 Transportation. *COMAR 10.21.18.13* If the therapeutic nursery provides transportation, the therapeutic nursery program shall ensure that: A. Vehicles used for the transport of therapeutic nursery enrollees are in compliance with the requirements outlined in Transportation Article, Title 22, Annotated Code of Maryland; B. Each driver: (1) Possesses a valid Class D license; and (2) Presents the driver's record, certified by the Motor Vehicle Administration, showing not more than two points, at the time of employment and annually after that; and C. In addition to the driver, at least one staff member is present in the vehicle to supervise the children at all times. ### Chapter 19 — Community Mental Health Programs — Mobile Treatment Services **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: January 2, 1995 (21:26 Md. R. 2188) **Administrative History:** Regulation .01C repealed effective August 24, 1998 (25:17 Md. R. 1360) **Administrative History:** Regulation .02-1 adopted effective August 24, 1998 (25:17 Md. R. 1360) **Administrative History:** Regulation .03F amended effective August 24, 1998 (25:17 Md. R. 1360) **Administrative History:** Regulation .04 amended effective August 24, 1998 (25:17 Md. R. 1360) **Administrative History:** Regulation .05 amended effective August 24, 1998 (25:17 Md. R. 1360) **Administrative History:** Regulation .06-1 adopted effective August 24, 1998 (25:17 Md. R. 1360) **Administrative History:** Regulation .07 repealed and new Regulation .07 adopted effective August 24, 1998 (25:17 Md. R. 1360) **Administrative History:** Regulation .08A amended effective August 24, 1998 (25:17 Md. R. 1360) #### Regulation .01 Scope. *COMAR 10.21.19.01* A. This chapter applies to programs organized to provide intensive, assertive mental health treatment and support services delivered by a multidisciplinary treatment team to an adult or a minor whose mental health treatment needs have not been met through routine, traditional outpatient mental health programs. Services are provided flexibly and in the various community settings determined by the needs of the individual. B. The purpose of mobile treatment services (MTS) is to enable the individual to: (1) Remain in the community, thus reducing the individual's admissions to emergency rooms, inpatient facilities, or detention centers; and (2) Achieve transition to less intensive outpatient services. #### Regulation .02 Definitions. *COMAR 10.21.19.02* In this chapter, terms have the meanings stated in COMAR 10.21.17. #### Regulation .02-1 Approval. *COMAR 10.21.19.02-1* The Department shall grant approval to a program to be eligible to receive State or federal funds for providing MTS if the program meets the requirements: A. For approval outlined in COMAR 10.21.16; B. For administration outlined in COMAR 10.21.17; and C. Of this chapter. #### Regulation .03 Program Model. *COMAR 10.21.19.03* The program director shall assure that services: A. Are therapeutic and are age and culturally appropriate; B. Are provided by MTS staff who: (1) As determined by the program, are appropriately credentialed and privileged; and (2) Are available: (a) As indicated in the screening assessment or the individual's ITP, to deliver services at a time and in a setting agreeable to the individual served; and (b) On an on-call basis, 24 hours per day, 7 days per week; C. Engage an individual who is unable or unwilling to use traditional mental health services by: (1) Using an assertive approach in making services available and acceptable to the individual by: (a) Identifying and addressing stressors that the individual identifies as priorities; (b) Developing creative individualized approaches in an effort to engage the individual in services; and (c) Recognizing that establishing a therapeutic relationship may take place over an extended period of time; and (2) Being sufficiently flexible to allow for the delivery of service in the setting and at the time that is appropriate for the individual's needs; D. Establish between the individual and the MTS staff a therapeutic relationship that includes mutual development of short-term and long-term goals for the individual; E. Respect the individual's privacy at the individual's residence by: (1) Except in an emergency, notifying the individual, in advance, of the time that MTS staff will visit the individual's home; (2) Having private conversations; (3) Obtaining the individual's permission to bring anyone else to the individual's home; and (4) If requested, terminating a home visit; and F. Assist the individual to interact with agencies and others to: (1) Have access to services and entitlements necessary to support adequate living conditions; (2) Maintain continuity of care by coordinating access to various treatment and rehabilitation services; (3) Promote community participation by engaging in age-appropriate social and recreational activities; and (4) Access housing, if necessary. #### Regulation .04 Eligibility, Screening, and Admission. *COMAR 10.21.19.04* A. Eligibility. An individual is eligible for MTS if: (1) Based on a screening assessment conducted according to the provisions of §B of this regulation, the individual would benefit from services that are: (a) Directed at providing mental health treatment; and (b) Available, by being delivered at a site that is accessible to an individual who: (i) Is homeless; (ii) Has been unable or unwilling to use, on a continuing basis, community-based mental health services that are prescribed for the individual; or (iii) Is in an institution or inpatient facility and would be able to reside in a community setting if the individual received MTS and other appropriate support services; and (2) The services are preauthorized by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.21.17.02-1A. B. Screening Assessment. (1) Within 10 working days of receipt of a referral for MTS, the MTS mental health professional who is assigned to conduct screenings shall: (a) Conduct a face-to-face screening assessment with the individual referred to assess the individual's: (i) Needs, strengths, and available resources; and (ii) Willingness to participate in MTS; (b) Meet with the individual in the individual's home or at a site that is most appropriate to the individual's needs and preferences; (c) As appropriate and with proper consent, meet with the family members and significant others designated by the individual; and (d) Unless the individual is referred to the Administration's ASO for alternative services under §B(2) of this regulation: (i) Determine priority for enrollment based on acuity of the individual's need; and (ii) Arrange an appointment for a psychiatric evaluation, as described under Regulation .05A of this chapter. (2) If, following the screening assessment under §B(1) of this regulation, the program director determines that the program's services are not appropriate for an individual who has been referred, the program director shall, in writing, promptly: (a) Inform the individual and, if the individual is a child, the parent or guardian, of the determination and the reason; (b) With proper consent, notify the family or significant others designated by the individual of the determination and of any recommendations for other services; and (c) Notify the CSA and the Administration's ASO for appropriate alternative referral. C. Admission. An MTS program shall admit an individual if the services are authorized, as needed, by the Administration's ASO, according to the provisions of COMAR 10.21.17.02-1A. #### Regulation .05 Evaluative Services Provided. *COMAR 10.21.19.05* A. Initial MTS Psychiatric Evaluation. Within 30 days of receipt of referral for MTS, the MTS psychiatrist, in collaboration with the individual's assigned treatment coordinator, shall conduct a face-to-face evaluation of the individual to: (1) Collect and evaluate relevant history; (2) Evaluate current mental status, including: (a) The need for medication; and (b) A review of current medications and source of prescriptions; (3) Assess the individual's general physical health, and either: (a) Perform a physical examination; (b) Document a physical examination of the individual during the prior year; (c) Refer the individual for a physical examination; or (d) Waive the requirement that the individual have a physical examination and document the rationale for the waiver; (4) Formulate and document the psychiatric diagnosis and the rationale for the diagnosis or affirm a psychiatric diagnosis that has been entered in the individual's MTS medical record; (5) In collaboration with the individual: (a) Identify the individual's needs, strengths, and goals; and (b) Assess the individual's level of functioning and availability of family and other social supports; (6) Document the rationale for the determination that MTS are medically necessary; and (7) Develop an initial brief plan of care. B. Diagnosis. (1) As required under §A(4) of this regulation, the MTS psychiatrist shall conduct the evaluation and formulate and document the psychiatric diagnosis or affirm a psychiatric diagnosis that has been entered in the individual's MTS medical record. (2) An individual qualified to diagnose under the provisions of Health Occupations Article, Annotated Code of Maryland, may provide continuing psychiatric diagnosis. C. Individual Treatment Plan (ITP). (1) Treatment Team. At least the following shall participate as members of an individual's MTS treatment team: (a) The MTS psychiatrist or a third-year or fourth-year psychiatric resident who is supervised by the MTS psychiatrist; (b) A licensed social worker; (c) A registered nurse; (d) The individual's treatment coordinator, as defined under Regulation .09 of this chapter; and (e) When available, any other staff involved in providing services to the individual. (2) Initial ITP. Before the 45th day after an individual is admitted to MTS, based on the screening assessment under Regulation .04B of this chapter and psychiatric evaluation under Regulation .05A of this chapter, the treatment team, under the direction of the treatment coordinator, in collaboration with the individual and, with proper consent, family members or significant others designated by the individual, shall prepare an ITP that includes: (a) The psychiatric diagnosis; (b) Description of the individual's current behavior and level of functioning that includes the individual's needs and strengths; (c) When relevant to the individual, a description of the family's or significant others' needs and strengths; (d) Short-term and long-term goals, including the plan for transitioning to traditional outpatient mental health services, that are outcome-oriented and that are stated in behavioral, measurable terms; (e) Treatment strategies, including: (i) Recommended type and frequency of interventions; (ii) The method of providing the services required under Regulation .06 of this chapter; and (iii) Target dates for goal achievement; and (f) The designation of MTS staff responsible for implementing the elements of the plan. (3) 3-Month ITP Review. At a minimum of every 3 months at a treatment team meeting, the individual's treatment coordinator, in collaboration with the individual, shall review the ITP and record in the individual's medical record: (a) A description of progress toward the goals; (b) Changes in goals and interventions based on the review of progress documented by the individual's treatment coordinator; and (c) A statement validating the need for continued MTS. (4) Signature of the ITP and ITP Reviews. (a) The individual shall sign or tape record agreement or disagreement with the plan. (b) The MTS psychiatrist and the individual's treatment coordinator shall sign the ITP and the ITP 3-month reviews. D. Continuing Evaluation. In order to ensure that services to an individual are timely and appropriate, the staff shall document in the individual's medical record: (1) Contact notes, regarding all face-to-face and other clinically relevant contacts with or about the individual; and (2) Progress summary notes, entered at least monthly by the individual's treatment coordinator, that include: (a) A description of progress toward the goals; and (b) Changes in goals and interventions based on the review of progress. #### Regulation .06 Treatment and Support Services Provided. *COMAR 10.21.19.06* A. Medication Services. (1) Evaluation and Prescription. When prescribing medication for an individual, the MTS psychiatrist shall: (a) Conduct a face-to-face evaluation of the individual; (b) Through a medical history, evidence of a recent physical examination, records review, laboratory testing, or other appropriate measures, assure that there are no contraindications to the prescription of specific medications; (c) Document in the individual's medical record the rationale for prescribing the medication; (d) Explain to the individual or the individual's legal guardian both the benefits and the side effects of prescribed psychiatric medications before and, when appropriate, during treatment and document the explanation in the individual's medical record; and (e) Order and monitor tests at medically recommended intervals and document the results in the individual's medical record. (2) Administration. (a) An individual licensed under Health Occupations Article, Annotated Code of Maryland, to administer medication may do so. (b) A licensed practical nurse or a registered nurse may delegate the administration of medication only according to the provisions of COMAR 10.27.11. (3) Monitoring. When required by the individual's ITP, a member of the treatment team credentialed and privileged to do so shall provide the following services: (a) Supporting the individual's self-administration of prescribed medication; (b) To the extent possible, monitoring compliance with instructions appearing on the label; (c) Reading the label to ensure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date; (d) Ensuring that each individual has secure, appropriate, and accessible space in which to store medications; (e) Observing and documenting any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicating to the prescribing authority any problems that possibly may be related to the medication; and (f) Reinforcing education on the role and effects of medication in symptom management. (4) Education Regarding Medication. As required by an individual's ITP, a nurse, a physician, or other privileged and credentialed staff shall educate the individual and, with the individual's consent, the individual's family or significant others, by: (a) Verifying the individual's understanding of the directions for administration of medication; and (b) Providing information regarding: (i) The role, effects, and importance of medication in symptom management; (ii) Expected benefits and expected side effects of prescribed medication; and (iii) Nutritional and dietary expectations and risks related to the individual's medication regimen. B. Independent Living Skills Assessment and Training. The MTS staff shall: (1) In collaboration with the individual, assess the individual's level of functioning in the areas of: (a) Community living skills, including but not limited to: (i) Mobility training; and (ii) Money management; (b) Activities of daily living, including: (i) Meal planning and preparation; (ii) Personal hygiene; and (iii) Grooming; and (c) Interpersonal and socialization skills, including: (i) Communication; and (ii) Leisure and social activities; and (2) Based on the assessment conducted under §B(1) of this regulation, provide rehabilitation activities to assist with and facilitate the individual's acquisition and improvement of independent living skills. C. Health Promotion and Training. (1) To supplement and support the somatic health care provided by an individual's primary health care provider, the MTS psychiatrist or registered nurse shall carry out health promotion activities, including but not limited to: (a) Monitoring of a chronic medical condition that is managed by a primary health care provider, including: (i) Teaching on illness prevention and wellness maintenance; and (ii) Reinforcement of instructions given by the primary health care provider; (b) Evaluating an acute problem to determine the most appropriate health care provider and referring the individual to the provider; and (c) Assisting an individual to understand and carry out health-care-related behaviors, including activities related to diagnostic testing preparation and prescribed treatment for acute and short-term illness. (2) When indicated in the individual's ITP, MTS staff shall provide basic health teaching in the following areas: (a) Nutrition; (b) Exercise; (c) Dental care; (d) Substance abuse prevention; and (e) Prevention of injury and illness at home and in the community. (3) MTS staff credentialed and privileged to do so shall provide training in communicable disease prevention, including prevention of sexually transmitted diseases and bloodborne pathogens, including HIV/AIDS. D. Interactive Therapies. MTS staff shall provide, as required in the individual's ITP, therapies, including individual, group, and family therapy focused on: (1) Assessment and definition of problems; (2) Planning and goal setting; (3) Development of effective problem-solving techniques; (4) Evaluation of progress; and (5) Other issues raised by the individual. E. Crisis Intervention Service. The MTS treatment team shall provide to an individual who is receiving MTS a crisis intervention service that is: (1) Designed to be implemented in the event of a crisis in the home or other setting in which the individual is involved; (2) Explained in terms understandable to the individual; and (3) Available, on an on-call basis, 24 hours per day, 7 days per week. F. Support, Linkage, and Advocacy. The MTS treatment team shall assure appropriate coordination with community and family resources that are considered essential to meeting the individual's identified needs, including but not limited to intervention and advocacy with: (1) MTS staff and other community mental health and rehabilitation service providers; (2) Mental health clinic and psychiatric rehabilitation programs; (3) Social service agencies; (4) Courts and detention centers; (5) Providers of needed medical and dental services; (6) Immediate and extended family members; (7) For school age children, the educational system; and (8) Recreational activities. #### Regulation .06-1 Supported Housing Services for Adults. *COMAR 10.21.19.06-1* A. Housing Development. The program director shall ensure that the program: (1) Collaborates with the CSA in developing the CSA's plan for affordable, accessible housing in the community; (2) Maintains information about available regular housing that is: (a) Integrated throughout the community; (b) Not limited as to length of stay, or conditional upon an individual's participation in mental health treatment or support services; and (c) Within the price range that is affordable to individuals enrolled in the program; and (3) In conjunction with the CSA: (a) Attempts to develop financial resources to assist an individual temporarily in such circumstances as an individual's hospitalization or loss of job, benefits, or housemate; and (b) Establishes priorities by which housing financial resources are allocated to individuals. B. Housing Needs Assessment. The program director shall ensure that program staff, in collaboration with the individual, conduct an assessment of: (1) The individual's housing needs; and (2) If the individual does not have housing that the individual considers adequate, the rehabilitative skills that the individual needs to obtain the housing of choice. C. Accessing and Sustaining Housing. The program director shall ensure that the program provides, as needed by and acceptable to the individual, services that are directed at: (1) Assisting an individual in making choices about where and with whom to live by developing or restoring the basic social and living skills needed to: (a) Link, when interested, with other individuals with similar interests and housing requirements; (b) Evaluate financial resources, available natural supports, and needed and desired community services; (c) Locate available properties and, when interested, negotiate acquisition; and (d) Secure available financial entitlements and U.S. Department of Housing and Urban Development Section 8 and other types of housing financial assistance; (2) Developing or restoring appropriate basic living skills and supports to keep housing, such as: (a) Responsibilities for upkeep of the property and personal belongings; (b) Maintaining an adequate supply of food and household goods; (c) Development of community resources and natural supports; (d) Housemate conflict resolution; and (e) Landlord-tenant negotiations regarding such issues as rent, needed repairs, and complaints; and (3) Additional support, as determined by the individual's need. #### Regulation .07 Discharge and Transitioning. *COMAR 10.21.19.07* A. Discharge Procedures. (1) An MTS program may discharge an individual from MTS only when: (a) The individual: (i) Is unwilling to continue to accept MTS; (ii) Is admitted to an inpatient facility for longer than 3 months; or (iii) Moves from the area served by MTS; or (b) The Administration's ASO determines that transition and discharge from MTS is medically appropriate. (2) When an MTS program discharges an individual under §A(1)(a)(i) or (ii) of this regulation, the MTS program shall, as authorized: (a) Permit the individual to re-enroll in MTS; and (b) Make assertive efforts to re-enroll the individual. (3) When an MTS program discharges an individual under §A(1)(a)(iii) of this regulation, the MTS program shall, when possible and as authorized, refer the individual for appropriate mental health and support services in the individual's community. (4) When transition and discharge from MTS is authorized under §A(1)(b) of this regulation, the MTS treatment coordinator, in collaboration with an individual, shall: (a) Document the individual's: (i) Achievement of treatment goals; (ii) Anticipated needs for treatment and rehabilitation services; and (iii) Readiness for participation in outpatient mental health clinic (OMHC) or other appropriate outpatient mental health services, as demonstrated by keeping appointments, using transportation independently, obtaining and taking prescribed medications, and actively participating in treatment; and (b) In consultation with the Administration's ASO, prepare a transition plan, according to the provisions of §B of this regulation. B. Transition Services. When the Administration's ASO authorizes a transition plan, the individual's treatment coordinator, in consultation with the Administration's ASO, shall: (1) Arrange transition services in collaboration with: (a) The individual; (b) The treatment team; (c) As appropriate and with proper consent, family members and significant others designated by the individual; and (d) Designated transition service providers; (2) Provide authorized MTS transition services, refer the individual for other appropriate services, and arrange to initiate authorized services before a planned discharge; (3) With proper consent and as authorized by the Administration's ASO, facilitate the individual's transition to other appropriate services by: (a) Inviting the designated provider or providers of mental health services to whom the individual has been referred to participate in the transition planning; (b) Forwarding to the provider or providers a copy of the transition and discharge plan; and (c) For a period of time based on the individual's needs, periodically meeting with the individual and the provider or providers, as necessary to facilitate transition; (4) If the individual does not successfully complete transition, arrange, if authorized by the Administration's ASO, for the continuation of MTS; and (5) Complete a discharge summary in accordance with COMAR 10.21.17.07D(3). #### Regulation .08 Required Staff. *COMAR 10.21.19.08* A provider of MTS shall ensure that the MTS staff includes, at a minimum: A. A program director who: (1) Is a mental health professional; (2) Is available to provide MTS administration and supervision: (a) If fewer than 40 individuals are receiving services, for an amount of time calculated on the basis of 1/2 hour per week for each individual who is receiving services; or (b) If 40 or more individuals are receiving services, 20 hours per week; (3) Is responsible for operational oversight for, at a minimum: (a) Fulfilling the administrative requirements under COMAR 10.21.17 and the day-to-day clinical responsibilities for MTS; (b) Recruiting, hiring, training, and supervising staff; (c) Developing and implementing the budget; (d) Keeping the governing body informed of, at a minimum, the program's approval status and performance; (e) Ensuring that MTS are available to the individual, if needed, 24 hours per day, 7 days per week, and establishing on-call responsibilities; (f) Ensuring continuity of care during the time that an individual is receiving MTS by evaluating caseloads and coordinating staff schedules; and (g) Ensuring that transition services are provided; and (4) May carry out any of the clinical and training duties of a mental health professional or other MTS staff; B. A psychiatrist who: (1) Is involved, for an amount of time calculated on the basis of at least 1/4 hour per week for each individual who is receiving services, in: (a) Consultation with MTS staff; and (b) Evaluating and providing MTS; (2) Ensures that MTS are provided in accordance with accepted standards of medical practice; (3) Following a screening evaluation of an individual completed under Regulation .04B of this chapter, has an initial face-to-face contact with the individual, as required under Regulation .05A of this chapter, to: (a) Formulate and document the psychiatric diagnosis or affirm a psychiatric diagnosis that has been entered in the individual's MTS medical record; (b) Assess medical needs; (c) Confirm the medical necessity of MTS; (d) When appropriate, order MTS for the individual; and (e) Authorize the initial ITP; (4) Is responsible for, at a minimum, the following: (a) Evaluating the individual, face-to-face, at least every 3 months; (b) As required under the provisions of Regulation .05C of this chapter, participating in the development, required periodic review, and signing of an individual's ITP; (c) Prescribing medication and providing other medication services outlined in Regulation .06A of this chapter; (d) Providing the appropriate treatment indicated in the individual's ITP; and (e) Supervising psychiatric residents, if any, who provide MTS, including, if duties are delegated, providing, at least monthly, a review of the status of the individuals whom the resident is treating; (5) May delegate the following duties to a third-year or fourth-year resident of an accredited program in psychiatry: (a) Except for the initial 3-month evaluation, the periodic evaluations required under §B(4)(a) of this regulation; (b) Participation in the development, required periodic review, and signing of an individual's ITP, required under §B(4)(b) of this regulation; (c) If the resident is a licensed physician, prescribing medication and providing other medication services, as provided under §B(4)(c) of this regulation; and (d) As provided in §B(4)(d) of this regulation, providing the appropriate treatment indicated in the individual's ITP; and (6) May not delegate: (a) The initial psychiatric evaluation; (b) Formulation and documentation of the psychiatric diagnosis or affirmation of a psychiatric diagnosis that has been entered in the individual's MTS medical record; or (c) Ordering of MTS for an individual; C. A registered nurse who: (1) Is licensed under the provisions of Health Occupations Article, Title 8, Annotated Code of Maryland; (2) Participates in MTS for an amount of time calculated on the basis of at least 1 hour per week for each individual who is receiving services; and (3) As permitted under Health Occupations Article, Annotated Code of Maryland, performs assigned duties that the nurse is credentialed and privileged to perform, including but not limited to: (a) Medication administration and other medication services outlined in Regulation .06A of this chapter; and (b) Health promotion and training, as outlined in Regulation .06C of this chapter; D. At least one social worker who: (1) Is licensed under the provisions of Health Occupations Article, Title 19, Annotated Code of Maryland; and (2) As permitted under Health Occupations Article, Annotated Code of Maryland, performs assigned duties the social worker is credentialed and privileged to perform, including but not limited to: (a) Interactive therapies, as outlined in Regulation .06D of this chapter; (b) Support, linkage, and advocacy, as outlined in Regulation .06F of this chapter; and (c) Discharge and transition services as outlined in Regulation .07 of this chapter; and E. At least one mental health professional who: (1) May include the staff identified in §§C and D of this regulation; and (2) As permitted under Health Occupations Article, Annotated Code of Maryland, performs assigned duties that the mental health professional is credentialed and privileged to perform, including but not limited to: (a) Conducting the screening evaluation required under Regulation .04B of this chapter and participating in the initial psychiatric evaluation required under Regulation .05A of this chapter; (b) According to the provisions of Regulation .05C of this chapter, reviewing and signing an individual's ITP; (c) The duties outlined in Regulations .06 and .07 of this chapter that the mental health professional is licensed or credentialed and privileged to perform; (d) When credentialed and privileged by the program to do so, functioning as the treatment coordinator for individuals who are receiving MTS; (e) Supervising direct service providers; and (f) Assuring that, before the provision of MTS and, as needed, on an in-service basis, appropriate training is provided to direct service providers. #### Regulation .09 Treatment Coordinator. *COMAR 10.21.19.09* The program director shall assign to each individual who is receiving MTS a mental health professional who is the individual's treatment coordinator, and who shall: A. Assess the individual's needs by: (1) Collaborating in the initial psychiatric evaluation conducted according to the provisions of Regulation .05A of this chapter; and (2) Collecting and evaluating relevant history; B. Establish and maintain a therapeutic relationship; C. Direct the development of the ITP and required periodic updates, as outlined in Regulation .05C of this chapter; D. Ensure appropriate linkage with treatment services by providing: (1) Outreach, which includes: (a) Meeting with the individual in the individual's home or at a site that is most appropriate to the individual's needs and preferences; and (b) Crisis intervention; (2) Advocacy, which includes assisting the individual to acquire treatment and rehabilitation services acceptable to the individual and entitlements, housing, and other basic necessities; and (3) Coordination of service plans with other agencies and providers; E. Monitor the progress of the individual by: (1) Conducting periodic assessments of the individual's living situation; (2) Conducting face-to-face assessments of the individual's mental status, including the individual's: (a) Appearance; (b) Behavior; (c) Affect; (d) Thought processes; (e) Judgment; and (f) Insight; and (3) Maintaining progress summary notes, as required under the provisions of Regulation .05D(2) of this chapter; F. As required by the individual's ITP, provide interactive therapies delineated under Regulation .06D of this chapter; and G. When appropriate, recommend discharge and prepare, with the individual, a discharge plan, according to the provisions of Regulation .07 of this chapter. #### Regulation .10 Additional Staff. *COMAR 10.21.19.10* As needed, based on the number of individuals served, the program director may include on the MTS staff direct service providers who: A. May include the staff identified in Regulation .08C and D of this chapter; and B. As permitted under Health Occupations Article, Annotated Code of Maryland, perform assigned duties that the direct service provider is credentialed and privileged to perform. #### Regulation .11 Capacity. *COMAR 10.21.19.11* A provider of MTS shall base the capacity of the MTS program on the basis of one full-time treatment staff person for each 12 individuals served. ### Chapter 20 — Community Mental Health Programs — Outpatient Mental Health Centers **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: February 13, 1995 (22:3 Md. R. 153) **Administrative History:** Chapter revised effective November 16, 1998 (25:23 Md. R. 1696) **Administrative History:** Regulations .01 — .08 repealed and new Regulations .01 — .11 adopted effective January 14, 2008 (35:1 Md. R. 19) **Administrative History:** Regulation .07B amended effective April 29, 2013 (40:8 Md. R. 724) #### Regulation .01 Scope. *COMAR 10.21.20.01* This chapter applies to programs that provide mental health treatment services to individuals on an outpatient basis. #### Regulation .02 Definitions. *COMAR 10.21.20.02* In this chapter, terms have the meanings stated in COMAR 10.21.17. #### Regulation .03 Approval. *COMAR 10.21.20.03* A. The following applicants shall be eligible for approval as an outpatient mental health center (OMHC), if the applicant demonstrates experience providing mental health services for a minimum of 1 year: (1) A group practice; or (2) A program currently approved under another Mental Hygiene Administration community mental health program chapter. B. The Department shall grant approval to a program to be eligible to receive State or federal funds for providing services if the program meets the requirements: (1) Outlined under §A of this regulation; (2) For approval outlined in COMAR 10.21.16; (3) For administration outlined in COMAR 10.21.17; (4) For Medical Assistance providers outlined in COMAR 10.09.36, 10.09.59, and 10.09.70; and (5) Of this chapter. #### Regulation .04 Program Model. *COMAR 10.21.20.04* A. An outpatient mental health center (OMHC) shall provide services that are: (1) Age and culturally appropriate; (2) Coordinated with other components of the service delivery system; and (3) Focused on recovery and resiliency. B. An OMHC shall ensure that clinical services are only rendered by mental health professionals who are authorized under Health Occupations Article, Annotated Code of Maryland, and appropriately credentialed by the program to perform the service. C. An OMHC shall ensure that the services required under this chapter are accessible and available: (1) At least 40 hours per week; (2) During some weekend and evening hours; and (3) For emergency coverage, 24 hours per day, 7 days per week as specified in Regulation .08F of this chapter. D. An OMHC shall: (1) Have a facility that: (a) Meets all relevant federal, State, or local ordinances, laws, regulations, and orders governing the program; (b) Is not located in a private residence; (c) Is accessible to the public; and (d) Contains a secure area where records, logs, and business information may be kept; and (2) Prominently display the hours of operation of the facility or office. E. Intensive Outpatient Services. (1) An OMHC may provide short-term, intensive outpatient services. (2) If an OMHC provides intensive outpatient services, the services shall: (a) Be delivered by a multidisciplinary team for a minimum of 3 hours of therapeutic services per day; and (b) Include: (i) At least two group therapies; and (ii) Physician services as needed. (3) For individuals receiving intensive outpatient services, the individual's ITP shall be reviewed weekly by the individual and the individual's treatment coordinator. #### Regulation .05 Eligibility, Screening, Enrollment, and Orientation. *COMAR 10.21.20.05* A. Eligibility. (1) An individual is eligible for services through the public mental health system (PMHS) if the services are preauthorized, if required, by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.21.17.03A. (2) In addition to those individuals described in §A(1) of this regulation, an OMHC may provide services to other individuals who wish to contract privately for services. (3) If an OMHC provides services to an individual described in §A(2) of this regulation, an OMHC may not seek reimbursement by the PMHS for providing services to that individual. B. Screening Assessment. (1) An OMHC licensed mental health professional, in collaboration with the individual referred, shall conduct a screening assessment to assess the individual's goals for recovery, strengths, available resources, and treatment needs: (a) Within 5 working days of receipt of a referral from an inpatient facility for OMHC services; or (b) By the date established under §B(2) of this regulation for all other referrals. (2) For referrals that are not from an inpatient facility, the program director shall: (a) In collaboration with the medical director, establish a procedure to review clinical acuity as described by the referral source; (b) Based on the review of clinical acuity described in §B(2)(a) of this regulation, establish the date for a screening assessment; and (c) Inform the individual of: (i) The date established for the screening assessment; or (ii) If, due to program capacity, there will be a delay in the screening assessment, a tentative time frame for services. (3) If, following the screening assessment under §B(1) of this regulation, the OMHC program director, or licensed mental health professional designated by the program director, determines that the OMHC's services are not appropriate for an individual referred, the OMHC shall advise the individual and, if appropriate, notify the ASO and CSA. C. Enrollment. Unless an individual has been determined to be clinically inappropriate for services under the provisions of §B(3) of this regulation, an OMHC shall: (1) Initiate evaluation and treatment services for an individual who has been referred from an inpatient facility, within 5 working days of the screening assessment conducted under §B(1) of this regulation; or (2) For all other referrals screened under §B(2) of this regulation, the program director shall: (a) In collaboration with the medical director, establish a procedure to review clinical acuity as described by the referral source; (b) Assign priority for OMHC services based on clinical acuity; (c) Inform the individual of: (i) The estimated date evaluation and treatment services may be initiated; and (ii) If, due to program capacity, there will be a delay in the initiation of treatment services, alternative services that are available. D. Orientation. The program director shall ensure that an individual who has been enrolled in the OMHC, or if the individual is a minor, the minor's parent or guardian, receives an orientation as outlined in COMAR 10.21.17.04B. #### Regulation .06 Evaluative Services Provided. *COMAR 10.21.20.06* A. Assessment and Diagnosis. The medical director shall ensure that an appropriate licensed mental health professional shall, by the individual's second visit and based on the initial face-to-face diagnostic evaluation of the individual: (1) Formulate and document in the individual's medical record information that includes: (a) A description of the presenting problem; (b) Relevant history, including family history and somatic problems; (c) Mental status examination; and (d) A diagnosis and the rationale for the diagnosis; or (2) Document: (a) The reason for not formulating a diagnosis; and (b) A plan, including time frame, for formulating a diagnosis. B. Co-Occurring Substance Abuse Screening Assessment. The face-to-face diagnostic assessment conducted under §A of this regulation shall include a screening assessment, using a scientifically validated, and if available, age appropriate tool, to determine whether the individual has a co-occurring substance abuse disorder. C. Additional Assessment for a Minor. In addition to the requirements outlined in §A of this regulation, before a minor's fifth visit, the minor's assigned treatment coordinator shall: (1) Conduct a face-to-face evaluation with the minor to assess the minor's level of functioning and availability of family and other social supports; and (2) If a comprehensive assessment, that includes the elements listed in §C(2) of this regulation, has not been completed within the 6 months before enrollment, assure the completion of an assessment, that includes, at a minimum, the minor's: (a) Developmental history; (b) Educational history and current placement; (c) Home environment; (d) Family history and evaluation of the current family status, including legal custody status; (e) Social, emotional, and cognitive development; (f) Motor, language, and self-care skills development; (g) History, if any, of substance abuse; (h) History, if any, of physical or sexual abuse; (i) History, if any, of out-of-home placements; and (j) Involvement, if any, with the local department of social services or Department of Juvenile Services. D. Review of Somatic Status. (1) According to the provisions described in §D of this regulation and upon an individual's enrollment into the program, an appropriate licensed mental health professional shall document in the individual's medical record: (a) Pertinent past and current somatic medical history including: (i) The individual's somatic health problems, if any, including but not limited to allergies, neurologic disorders, and communicable diseases; (ii) Relevant medical treatment, including medication; and (iii) A recommendation, if any, for somatic care follow-up; (b) If the individual does not have a primary care provider, the plan, if indicated, including the time frame, for the individual's referral to a primary care provider for evaluation and treatment; and (c) An exchange of medical information with the primary care provider. (2) With proper consent and if clinically indicated, the individual's treatment coordinator shall maintain and document ongoing collaboration and coordination with the individual's primary care provider. #### Regulation .07 Treatment Planning and Documentation. *COMAR 10.21.20.07* A. Individual Treatment Plan (ITP). (1) Initial ITP. (a) Not later than the fifth visit after an individual is enrolled in an OMHC and based on the assessment conducted under Regulation .05B of this chapter, the treatment coordinator and the individual, and if the individual is a minor, the minor's parent, guardian, or primary caretaker if appropriate, shall develop an ITP in collaboration with: (i) With proper consent, family or others designated by the individual, and others involved in the individual's care; and (ii) Other OMHC staff, as appropriate. (b) The ITP shall include, at a minimum: (i) The individual's diagnosis; (ii) The individual's presenting needs, strengths, recovery, and treatment expectations and responsibilities; (iii) A description of needed and desired treatment and interventions to be provided, specifying the modality, frequency, and responsible staff; (iv) A description of how the needed and desired treatment will help the individual to manage the individual's psychiatric disorder and to support recovery; (v) Short-term and long-term treatment goals in measurable terms and target dates for each goal; and (vi) If appropriate, identification of, referral for, and collaboration with other services or child service agencies and providers to support the individual's treatment and recovery, including but not limited to mental health residential services, psychiatric rehabilitation services, self-help organizations, vocational programs, substance abuse services, the local department of social services, the local department of juvenile services, schools, and somatic care. (c) The content of the ITP shall be communicated to: (i) Relevant program staff; and (ii) With proper consent, family or others designated by the individual and, if applicable, community mental health programs providing services to the individual. (2) ITP Review. As frequently as necessary, as determined by the individual and the individual's treatment coordinator, and at a minimum of every 6 months, the individual and the treatment coordinator shall: (a) Review the ITP with the individuals identified under §A(1) of this regulation; (b) Based on the review, record in the individual's medical record: (i) An assessment of the individual's progress toward the accomplishment of previously identified treatment goals that incorporates the perspective of the individual served; (ii) Goal changes based on a review of progress; (iii) Changes in treatment strategies; and (iv) Changes in diagnosis, if any; and (c) Communicate the results of the treatment plan review to: (i) Relevant program staff; (ii) With proper consent, substance abuse treatment providers and primary care provider, as appropriate; (iii) With proper consent, family or others designated by the individual and community mental health programs providing services to the individual. (3) Signature of the ITP and Reviews. (a) Except as provided in §A(3)(b) of this regulation, the individual shall sign agreement with the plan and reviews. (b) If the individual is unwilling to sign agreement with the plan and reviews, the individual's treatment coordinator shall: (i) Verify the individual's verbal agreement with the plan and reviews; and (ii) Document the rationale for the individual's refusal to sign. (c) If the individual is a minor, the minor's parent or guardian, or if other than the minor's parent or guardian, the minor's primary caretaker shall sign agreement with the plan and reviews. (d) With proper consent, family or others designated by the individual, including the individual's caregivers, may sign the plan and reviews. (e) At least two licensed mental health professionals who collaborate about the individual's treatment, shall sign the plan and reviews. (f) If the individual is receiving medication prescribed through the OMHC, an OMHC psychiatrist, or Certified Registered Nurse Practitioner in psychiatry, whomever prescribes the medication, shall sign the plan and reviews. (4) Upon completion of an ITP or ITP review, an individual's treatment coordinator shall assure that the individual is offered a copy of the plan or review and document the individual's acceptance or decline of the offer in the individual's medical record. (5) Individual Treatment and Rehabilitation Plan (ITRP). Staff may combine the required elements of an ITP and IRP in one document, the ITRP. B. Continuing Evaluation and Treatment. (1) Contact Note. Staff shall document each contact with the individual, including, at a minimum: (a) The date; (b) The start time and either the duration or the end time; (c) The individual's chief medical complaint or reason for the visit; (d) The individual's mental status; (e) The delivery of services specified by the ITP; (f) A brief description of the service provided; (g) The plan for changes in treatment, if any; (h) The individual's progress toward treatment goals; and (i) A legible signature, which may include an electronic signature, and printed or typed name of the licensed mental health professional providing care, with the appropriate title. (2) The treatment coordinator shall document any significant changes or events, including hospitalizations, that affect the individual's treatment. (3) The treatment coordinator shall ensure that the individual's needs and progress are communicated to: (a) Staff involved in the implementation of the ITP; and (b) With proper consent: (i) Community mental health programs providing services to the individual; and (ii) Family or others designated by the individual. #### Regulation .08 Treatment Services. *COMAR 10.21.20.08* A. An OMHC shall have the capacity to provide the treatment services outlined in §§B — F of this regulation as required by the individual's ITP. B. Mental Health Treatment. The program director shall ensure that licensed mental health professionals provide mental health treatment including: (1) Individual therapy; (2) Family therapy; and (3) Group therapy. C. Psychological Evaluation and Testing. The program director shall ensure that, if medically necessary and required by an individual's ITP, the OMHC provides psychological evaluation and testing by a staff psychologist or psychologist consultant, or by referral. D. Co-Occurring Substance Abuse Treatment. (1) The program director shall ensure that the program provides substance abuse treatment as a component of its mental health program for individuals with secondary co-occurring disorders or has a written plan to coordinate mental health services with a certified substance abuse program if necessary. (2) If the assessment conducted under Regulation .06B of this chapter indicates that the individual has a secondary co-occurring substance abuse disorder, the individual's treatment plan and progress notes shall: (a) If the program is providing substance abuse treatment, reflect the course of treatment relative to the disorder; or (b) If the program is not providing substance abuse treatment, with proper consent and if indicated, include documentation of coordination of care and collaboration with the provider of substance abuse services. E. Medication Services. (1) The medical director shall ensure that appropriate staff are trained and updated on the use, effect, interactions, and potential side effects of medication used by individuals served by the program. (2) Appropriate licensed mental health professionals shall, as clinically indicated, provide the following services: (a) Prescription; (b) Administration; (c) Monitoring; and (d) Education regarding medication. (3) Prescription. Staff identified under §E(2) of this regulation shall: (a) When initially prescribing medication for an individual: (i) Conduct a face-to-face evaluation of the individual; (ii) Assess whether there are contraindications to prescription of specific medications; (iii) Involve the individual in the choice of medication; (iv) Document in the individual's medical record the rationale for prescribing the medication; (v) Explain the benefits and possible side effects of taking or not taking prescribed psychiatric medications and document the explanation; (vi) With proper consent and if appropriate, promptly notify anyone responsible for administering or monitoring medication, of the medication regimen; and (vii) With proper consent and if clinically indicated, notify the individual's primary care physician of medication prescription, if any; and (b) If managing medication on an ongoing basis: (i) At a minimum of every 90 days, evaluate the individual face-to-face; (ii) Alter medications and adjust dosage as clinically indicated; (iii) Document the rationale for the current prescription; (iv) Order and monitor tests at medically recommended intervals and document results in the individual's medical record; (v) Educate the individual and others designated by the individual about prescribed medications, including the name of medication, dosage, frequency, proper storage, expected results, and potential side effects; (vi) With proper consent and if appropriate, promptly notify anyone responsible for administering or monitoring medication, of any changes in the medication regimen; and (vii) Notify the individual's primary care physician every 6 months of medication changes, if any. F. On-Call and Crisis Intervention Services. (1) The program director shall ensure that on-call and crisis intervention services are provided by a program's licensed mental health professional to an individual who has been enrolled in the OMHC: (a) Face-to-face during the 40 hours that the OMHC is open; or (b) By telephone, on an on-call basis, 24 hours per day, 7 days per week, during the hours the OMHC is not open: (i) Through the OMHC; or (ii) By written agreement with another OMHC or mental health crisis service provider. (2) If clinically appropriate, a crisis response plan or an advance directive for mental health services shall be developed and documented in the medical record, that: (a) An individual and, if the individual is a minor, the primary caretaker may implement in the event of or to prevent a crisis at home, school, work, or other setting in which the individual is involved; and (b) Is stated in terms that the individual and, if involved, the primary caretaker understand. #### Regulation .09 Support Services. *COMAR 10.21.20.09* A. In combination with one or more of the treatment services outlined in Regulation .08 of this chapter, an OMHC shall have the capacity to provide, as required by an individual's ITP, the support services outlined in §§B — E of this regulation. B. Referral Services. The program director shall ensure that the OMHC provides recommendations and referral, if appropriate, for: (1) Psychiatric rehabilitation and support services; (2) Somatic care; (3) Speech and language services; (4) Vision and hearing services; (5) Special instruction, special education, or other educational interventions; (6) Occupational therapy; (7) Self-help organizations; and (8) Substance abuse services. C. Education Regarding Medication. A nurse, a physician, or other appropriate licensed mental health professional shall educate the individual, and with proper consent, the individual's family or others designated by the individual, by: (1) Verifying the individual's understanding of the directions for administration of medication; and (2) Providing information regarding: (a) The role, effects, and importance of medication in symptom management; (b) Expected benefits and potential side effects of prescribed medication; and (c) Nutritional and dietary expectations and risks related to the individual's medication regimen. D. Case Coordination Services. If indicated, the treatment coordinator shall support the individual to: (1) Apply for all applicable entitlement programs; and (2) Access other needed services and resources, as appropriate. E. Linkage with an Individual in a Psychiatric Facility, RTC, RCS Program, or Detention Center. The program director shall maintain written policies and procedures, which may be contained in one document, for the purpose of continuity of care when individuals receive mental health services in more restrictive settings. #### Regulation .10 Program Staff. *COMAR 10.21.20.10* A. Required Staff. The OMHC shall have staff that is sufficient in numbers and qualifications to provide clinically appropriate services to the individuals served and includes, at a minimum: (1) A program director who is: (a) A licensed mental health professional, or has a master's degree in one of the following fields: (i) Mental health; (ii) Health services; or (iii) Business administration; (b) Employed by the OMHC at least 20 hours per week; and (c) Responsible for administrative oversight of the OMHC, including, at a minimum: (i) Fulfilling the administrative requirements under COMAR 10.21.17; (ii) Fulfilling the requirements of this chapter; (iii) Ensuring the continuity of service if clinical staff at the OMHC site are unavailable to fulfill their responsibilities to the individuals served; (iv) Ensuring a system of clinical supervision of the multidisciplinary treatment staff; and (v) Having knowledge of all regulatory requirements related to the operation of the program; (2) A medical director who: (a) Is a psychiatrist; (b) Is employed by and is on site at the OMHC at least 20 hours per week; (c) If employed full time by the program, may also serve as program director; and (d) Has overall responsibility for clinical services, including, at a minimum: (i) Establishing and maintaining appropriate standards for diagnosis and treatment, including therapeutic modalities and prescribing practices; (ii) Medical aspects of quality management; (iii) Adequate physician coverage; and (iv) Ensuring adequate clinical supervision of treatment staff; (3) A multidisciplinary licensed mental health professional staff that: (a) Provides evaluation and treatment services; (b) Is in addition to the OMHC psychiatrist; and (c) Includes representatives of two different mental health professions both of which are represented on-site 50 percent of the OMHC's regularly scheduled hours. B. Students. The program may use students according to the provisions of COMAR 10.21.17.12E. C. Volunteers. The program may use volunteers according to the provisions of COMAR 10.21.17.12F. #### Regulation .11 Multi-Facility Programs. *COMAR 10.21.20.11* A. An OMHC program that operates multiple sites shall assure that each additional site adheres to the application modification as outlined in COMAR 10.21.16.04E. B. The program director and the medical director shall, on a routine basis, and as clinically required, provide on-site consultation at each site to ensure adequate clinical and administrative oversight. C. The program shall designate for each additional OMHC site: (1) A clinical coordinator who: (a) Is a licensed mental health professional with demonstrated competency in clinical supervision; (b) Is located at each additional OMHC site for 50 percent of the site's regularly scheduled hours; (c) Has regular, direct access to the medical director and all clinical and administrative resources of the OMHC; and (d) Provides clinical oversight of the individuals served; (2) A psychiatrist who: (a) Need not be the medical director of the OMHC; and (b) Is on-site according to the needs of the individuals served; and (3) A multidisciplinary licensed mental health professional staff that: (a) Provides evaluation and treatment services; (b) Is in addition to the OMHC psychiatrist; and (c) Includes representatives of two different mental health professions both of which are represented on-site 50 percent of the OMHC's regularly scheduled hours. D. Staff at each additional OMHC site shall have direct access to the program director, the medical director, and all other clinical and administrative resources of the OMHC as needed. ### Chapter 21 — Community Mental Health Programs — Psychiatric Rehabilitation Programs for Adults **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: February 13, 1995 (22:3 Md. R. 153) **Administrative History:** Chapter revised effective September 7, 1998 (25:18 Md. R. 1434) **Administrative History:** Chapter revised effective January 14, 2008 (35:1 Md. R. 22) **Administrative History:** Regulation .06D amended effective January 21, 2013 (40:1 Md. R. 20) #### Regulation .01 Scope. *COMAR 10.21.21.01* This chapter outlines the service requirements and staffing standards for a psychiatric rehabilitation program (PRP) that provides psychiatric rehabilitation services to an adult at the program site or at an off-site location, including a residential rehabilitation program, appropriate to the individual's needs. #### Regulation .02 Definitions. *COMAR 10.21.21.02* In this chapter, terms have the meanings stated in COMAR 10.21.17. #### Regulation .03 Approval. *COMAR 10.21.21.03* The Department shall grant approval to a program to be eligible to receive State or federal funds for providing PRP services if the program meets the requirements: A. For approval outlined in COMAR 10.21.16; B. For administration outlined in COMAR 10.21.17; and C. Of this chapter. #### Regulation .04 Program Model. *COMAR 10.21.21.04* A. A provider of PRP services for adults shall: (1) Have a facility or office that: (a) Meets all relevant federal, State, or local ordinances, laws, regulations and orders governing the program; (b) Is not located in a private residence; (c) Is accessible to the public; and (d) Contains a secure area where records, logs, and business information may be kept; and (2) Prominently display the hours of operation of the facility or office. B. The program director shall organize program services and supports to: (1) Facilitate an individual's recovery, including the individual's ability to make decisions about the individual's life and create opportunities for choice regarding: (a) Home; (b) School or work; and (c) Community; and (2) Promote the use of community resources and self-help organizations to support the individual to participate fully in the community. C. The program director shall ensure that: (1) Services are: (a) Appropriate to the age of the populations being served; (b) Offered at times and places, according to the needs of the individuals served; and (c) Coordinated with other mental health services that the individual is receiving; (2) If the PRP provides services to individuals in a specific age group or with a particular clinical profile, the initiation of service criteria are consistent with the populations to be served; and (3) If the PRP provides services in a facility, the services are provided on a regular basis and include a variety of group and individual rehabilitation activities that incorporate individual rehabilitation goals, needs, and choices. #### Regulation .05 Eligibility, Screening, and Initiation of Service. *COMAR 10.21.21.05* A. Eligibility. An individual is eligible for PRP services if: (1) The individual is in need of program services to enable the individual to improve or restore independent living and social skills necessary to support the individual's: (a) Recovery; (b) Ability to make informed decisions and choices; and (c) Participation in community life; (2) The individual meets medical necessity criteria for PRP services; (3) The individual agrees to apply for medical assistance, as appropriate; and (4) The services are preauthorized, as needed, by the Administration's administrative services organization (ASO), according to the provisions of COMAR 10.21.17.04A. B. Screening. Within 10 working days of receipt by the program of a complete referral for PRP services: (1) Staff assigned by the program director shall conduct a screening assessment to determine whether rehabilitation services are medically needed by the individual; (2) If, following the screening assessment under §B(1) of this regulation, the program director determines that the program's services are not appropriate for an individual who has been referred, the program director shall, in writing: (a) Inform the individual of the determination and the reason; (b) Provide the individual with recommendations for alternative services, if appropriate; and (c) With proper consent, notify the referral source, the family, or others designated by the individual of the determination and of any recommendations for other services; (3) Unless the program director has notified the individual of the determination under §B(2) of this regulation, the program director shall notify the individual whether the program: (a) Accepts the individual, in which case, the program director shall identify a date that the program can initiate services to the individual; (b) Will accept the individual, following an updated review of the individual's eligibility status, when program capacity permits, in which case the program director shall inform the individual of the: (i) Individual's placement on a waiting list, if any; and (ii) Estimated date services may be initiated; or (c) Will accept the individual following the individual's discharge or release from an inpatient facility, RTC, or detention center; (4) If the individual is placed on a waiting list under §B(3)(b) of this regulation, the program staff shall discuss with the individual: (a) The option of remaining on the program's waiting list until the date established under §B(3)(b) of this regulation; and (b) Alternative services that are available. C. Entitlements and Fees. PRP staff assigned by the program director shall: (1) Determine if the individual has, or may be eligible, for federal or State entitlements; (2) Assist the individual, if necessary, to apply for all entitlements for which the individual may be eligible if the individual does not have entitlements; (3) Document in the individual's medical record: (a) That the individual has all entitlements; or (b) The outcome of the entitlement application; (4) Discuss with the individual the charges for services, and, when applicable, the process for determining ability to pay; and (5) Provide written documentation to the individual regarding the charges for services and the process for determining ability to pay. #### Regulation .06 Evaluation and Planning Services. *COMAR 10.21.21.06* A. Review of Somatic Status. (1) According to the provisions outlined in this section and upon an individual's enrollment into the program, a staff member assigned by the program director shall document in the individual's medical record: (a) Pertinent past and current medical history including: (i) The individual's somatic health problems, if any, including but not limited to allergies, neurologic disorders, and communicable diseases; (ii) Relevant medical treatment, including medications; and (iii) Needed somatic care follow-up, if any; and (b) When the individual does not have a primary care provider and if indicated, the plan, including the time frame, for the individual's referral to a primary care provider for evaluation and treatment. (2) When indicated, the individual's rehabilitation coordinator shall communicate with the individual's primary care provider and document the communication in the individual's medical record. (3) When indicated, the individual's rehabilitation coordinator shall discuss with the individual the need for medical and dental care, facilitate access to care, and document the communication in the individual's medical record. B. Rehabilitation Assessment. (1) Within 30 calendar days of initiation of PRP services, RRP services, or both, staff assigned by the program director to conduct assessments shall complete a face-to-face rehabilitation assessment with the individual and, with proper consent, family or others designated by the individual. (2) The assigned staff shall document in the rehabilitation assessment, at a minimum: (a) The individual's strengths, skills, wants, and needs in the following areas: (i) Independent living; (ii) Housing; (iii) Employment; (iv) Self-administration and management of medications; (v) Mobility and transportation; (vi) Social relationships and leisure activities; (vii) Education and vocational training; (viii) Adaptive equipment or resources; and (ix) Other factors that may pose a challenge to the individual's successful recovery and rehabilitation; (b) Current resources and support system; (c) As relevant, a review of the individual's legal status and forensic history, if any; (d) The individual's history of substance abuse, if any; (e) Behaviors, if any, that are potentially dangerous to the individual or others; and (f) For individuals receiving RRP services, the individual's: (i) Need for RRP services; (ii) Ability to perform basic self-care and to maintain personal safety; and (iii) Need for changing intensity of intervention based on the episodic nature of mental illness. C. Individual Rehabilitation Plan (IRP). (1) Initial IRP. Within 30 calendar days of initiation of PRP or RRP services and based on the rehabilitation assessment described in §B of this regulation, the individual and the individual's rehabilitation coordinator shall prepare an initial IRP: (a) In collaboration with: (i) And with proper consent, family or others designated by the individual, and others involved in the individual's care; and (ii) When appropriate and with proper consent, other mental health service providers, as available; and (b) That includes, at a minimum: (i) The individual's recovery and rehabilitation expectations and responsibilities; (ii) A description of needed and desired program services and interventions, and staff responsible for implementation; (iii) A description of how the needed and desired skills and supports will help the individual to manage the individual's psychiatric disorder and to support recovery; (iv) Rehabilitation goals in measurable terms, and target dates for each goal; (v) When appropriate, identification of, recommendations for, and collaboration with, other services to support the individual's recovery and rehabilitation, including but not limited to mental health treatment, residential services, self-help organizations, and somatic care; and (vi) For individuals receiving RRP services, the frequency of residential services and intensity of staff support. (2) Individual Treatment and Rehabilitation Plan (ITRP). With the individual and in collaboration with the mental health treatment coordinator, the rehabilitation coordinator may combine the required elements of an ITP and IRP in one document, the ITRP. (3) Rehabilitation Plan Review. At a minimum of every 6 months, the rehabilitation coordinator, with the individual, shall: (a) Review and record in the individual's medical record: (i) The individual's progress toward the accomplishment of previously identified rehabilitation goals; (ii) Goal changes, based on a review of the progress; and (iii) Changes in interventions, as appropriate; and (b) Communicate promptly the results of the review to: (i) Relevant program staff; and (ii) With proper consent, family or others designated by the individual, and community mental health programs providing services to the individual. (4) Signature of the IRP or ITRP and Reviews. (a) The following shall sign that they agree with the IRP or ITRP and reviews: (i) The individual; and (ii) The individual's rehabilitation coordinator. (b) With proper consent, family or others designated by the individual, including the individual's caregivers, may sign the IRP or ITRP and reviews. (c) If the individual is unwilling to sign agreement with the IRP or ITRP and reviews, the individual's rehabilitation coordinator shall: (i) Verify the individual's verbal agreement with the IRP or ITRP and reviews; and (ii) Document the rationale for the individual's refusal to sign. (d) In addition, for an ITRP, at least two licensed mental health professionals, who collaborate about the individual's treatment, shall sign the ITRP and ITRP reviews, including: (i) The individual's treatment coordinator; and (ii) If the individual is receiving medication prescribed through an outpatient mental health center (OMHC), the OMHC psychiatrist. (5) Upon completion of an IRP, ITRP, or review, an individual's rehabilitation coordinator shall assure that the individual is offered a copy of the plan or review and document the individual's receipt or decline of the offer in the individual's medical record. D. Continuing Evaluation. (1) Contact Notes. Staff shall document in the individual's medical record: (a) Each contact with or about the individual, including, at a minimum: (i) The date and location of service; (ii) The start time and either the duration or end time, unless the information is in a readily accessible billing document; (iii) The individual's chief medical complaint or reason for the visit; (iv) The delivery of services specified by the IRP or ITRP; (v) A brief description of the service provided; and (vi) A legible signature, which may include an electronic signature, and printed or typed name of the program staff member providing care, with the appropriate title; and (b) For individuals receiving RRP services, any change in intensity of staff support delivered at the RRP. (2) Monthly Summary Notes. At a minimum, each month the rehabilitation coordinator shall record in the individual's medical record, either a contact note or a progress summary note that includes: (a) An assessment of the individual's progress toward goal achievement that incorporates the perspective of both the individual served and staff involved; (b) Changes in the individual's status; and (c) A summary of the rehabilitation services and interventions provided. (3) If not documented in §D(1) or (2) of this regulation, the rehabilitation coordinator shall document any significant changes or events, including hospitalizations, that affect the individual's rehabilitation. (4) The rehabilitation coordinator shall document that the individual's wants and needs and progress are promptly communicated to: (a) Staff involved in the implementation of the IRP; and (b) With proper consent, family or others designated by the individual, and community mental health programs providing services to the individual. #### Regulation .07 Rehabilitation and Support Services Provided. *COMAR 10.21.21.07* A. Rehabilitation and support services may only be provided: (1) To an individual consistent with the individual's IRP or ITRP; and (2) By staff who have been determined competent by the program to provide the services. B. Rehabilitation and Recovery Activities. The program director shall ensure that the program provides rehabilitation activities directed toward the individual's recovery and the improvement or restoration of skills, including: (1) Self-care skills, including personal hygiene, grooming, nutrition, dietary planning, food preparation, and self-administration of medication; (2) Social skills, including community integration activities, developing natural supports, and developing linkages with and supporting the individual's participation in community activities; (3) Independent living skills, including: (a) Skills necessary for housing stability; (b) Community awareness; (c) Mobility and transportation skills; (d) Money management; (e) Accessing available entitlements and resources; (f) Supporting the individual to obtain and retain employment; and (g) Wellness self-management; and (4) Activities that support the individual's cultural interests. C. Medication Services. (1) Administration. (a) An individual licensed to administer medication under Health Occupations Article, Annotated Code of Maryland, may do so. (b) A licensed practical nurse or a registered nurse may delegate the administration of medication only according to the provisions of COMAR 10.27.11. (2) Monitoring. A PRP staff member shall provide the following services for psychiatric and somatic medications: (a) Support the individual's self-administration of prescribed medication; (b) Read the medication label to ensure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date; (c) To the extent possible, monitor compliance with instructions appearing on the medication label; (d) Ensure that each individual has secure, appropriate, and accessible space in which to store medications; (e) Observe and document any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicate to the prescribing authority any problems that possibly may be related to the medication; and (f) Reinforce, with the individual, education on the role and effects of medication in symptom management. D. Health Promotion and Training. PRP staff shall encourage health promotion activities, such as proper nutrition and exercise. E. Promotion of Individual Wellness Self Management and Recovery. (1) Staff shall: (a) Provide education and information regarding mental illness and recovery; and (b) Support the individual to identify effective strategies to assist the individual to manage the individual's wellness. (2) The strategies shall include, at a minimum, the individual's identification of: (a) Potential challenging symptoms; (b) Warning signs of relapse; (c) Helpful interventions; and (d) Other people the individual identifies to support the individual's recovery. (3) The individual's wellness self-management strategies shall be documented and may be incorporated in the individual's IRP, Residential Rehabilitation Program Managed Intervention Plan, as outlined in Regulation .08 of this chapter, mental health advance directive, or any combination of these items. (4) The strategies shall be reviewed at the time of the IRP review and may be revised or revoked at any time at the request of the individual. F. On-Call and Emergency Response. The program director shall assure that: (1) On-call and crisis intervention services are available 24 hours per day, 7 days per week, by telephone, to an individual who has been admitted to the PRP; and (2) All relevant staff shall assist the individual to access, as appropriate, the OMHC, mobile crisis, residential crisis services, hospitals, and other service providers that are designated to provide crisis and emergency care and treatment. G. Linkage with an Individual in a Psychiatric Inpatient Facility or Detention Center. (1) If an individual who is enrolled in a program is admitted to a psychiatric inpatient facility or detention center, the rehabilitation coordinator shall make reasonable efforts to maintain ongoing communication with the individual and the individual's inpatient treatment team. (2) To the degree permitted by the setting, PRP staff serving the individual shall participate in aftercare or release planning from that setting. #### Regulation .08 Residential Rehabilitation Program (RRP) Managed Intervention Plan (MIP). *COMAR 10.21.21.08* A. The program director shall: (1) Ensure that the program has a written policy regarding the development of and process for the implementation of a managed intervention plan (MIP) for an individual receiving RRP services; and (2) Upon initiation of service, document that the individual has received the written policy regarding the MIP. B. For an individual at risk of an unplanned discharge, the rehabilitation coordinator, in collaboration with the individual, shall prepare an MIP that includes: (1) Identification of the issues or symptoms that prompt the implementation of the MIP; (2) Steps and planned interventions, including, but not limited to: (a) A description of additional individualized services and supports that may be needed; (b) Verbal notification; (c) Written notification; (d) Temporary interruption of RRP services, which shall include: (i) The identification of temporary residential alternatives, if any; and (ii) Notification to the CSA; (e) Identification of the individuals involved in implementing the MIP; and (f) The signature of the: (i) Individual; (ii) Individual's rehabilitation coordinator; (iii) Individual's family or others, if designated by the individual. C. The elements of the MIP may be included in a revised IRP. #### Regulation .09 Supported Housing Services for Adults. *COMAR 10.21.21.09* A. Housing Development. The program director shall ensure that the program: (1) Collaborates with the CSA to access affordable housing in the community; (2) Maintains information about available regular housing that is: (a) Integrated throughout the community; (b) Not conditional upon an individual's participation in mental health treatment or support services; and (c) Within the price range that is affordable to individuals enrolled in the program; and (3) In conjunction with the CSA: (a) Attempts to develop financial resources to assist an individual temporarily in such circumstances as an individual's hospitalization or loss of job, benefits, or housemate; and (b) Establishes priorities by which housing financial resources are allocated to individuals. B. Housing Needs Assessment. The program director shall ensure that program staff, in collaboration with the individual, conduct an assessment of: (1) The individual's housing needs; and (2) If the individual does not have housing that the individual considers adequate, the rehabilitative skills that the individual needs to obtain the housing of choice. C. Accessing and Sustaining Housing. The program director shall ensure that the program provides, as needed by and acceptable to the individual, services that are directed at: (1) Assisting an individual in making choices about where and with whom to live by developing or restoring the basic social and living skills needed to: (a) Link, when interested, with other individuals with similar interests and housing requirements; (b) Evaluate financial resources, available natural supports, and needed and desired community services; and (c) Secure available private and public housing financial assistance; (2) Developing or restoring appropriate basic living skills and supports to keep housing, such as: (a) Responsibilities for upkeep of the property and personal belongings; (b) Development of community resources and natural supports; (c) Housemate conflict resolution; and (d) Landlord-tenant negotiations regarding such issues as rent, needed repairs, and complaints; and (3) Providing support, as determined by the individual's need. #### Regulation .10 Staff Qualifications and Responsibilities. *COMAR 10.21.21.10* A. Program Director. The program director: (1) Shall have sufficient qualifications, knowledge, and experience to execute the duties of the position; (2) Shall be knowledgeable of the regulations applicable to the program; (3) Shall be responsible for administrative oversight of the PRP including, at a minimum: (a) Fulfilling the administrative requirements under COMAR 10.21.17; (b) Fulfilling the programmatic requirements of this chapter; (c) Keeping the advisory committee, or governing body, whichever is applicable, informed of, at a minimum, the program's approval status and performance; (d) Quality management; and (e) Ensuring the development of a staffing plan that identifies the type and number of staff needed to provide a program of rehabilitation and recovery services for individuals with serious mental illness; and (4) May be responsible for the duties of the psychiatric rehabilitation specialist under §B of this regulation as specified in Regulation .11B — D of this chapter. B. Psychiatric Rehabilitation Specialist. The program director shall employ at least one psychiatric rehabilitation specialist who: (1) Is either a: (a) Licensed mental health professional; (b) Rehabilitation counselor who is currently certified by the Commission on Rehabilitation Counselor Certification; or (c) Bachelor's prepared certified psychiatric rehabilitation practitioner currently certified by the U.S. Psychiatric Rehabilitation Association; (2) Develops and assures that rehabilitation services meet the needs of the individuals served by the program; (3) Oversees the daily program of rehabilitation services; and (4) Educates direct care staff on how to provide rehabilitation services that correlate to the goals identified in the individual's IRP or ITRP. C. Psychiatric Rehabilitation Direct Care Staff. The program shall employ psychiatric rehabilitation direct care staff who: (1) Have 40 hours of PRP training before independently providing PRP services; (2) Have, at a minimum, a high school diploma or equivalency diploma; and (3) Are responsible for implementing the rehabilitation activities outlined in the individual's IRP. #### Regulation .11 Required Program Staff. *COMAR 10.21.21.11* A. A provider shall ensure that the staff of the PRP includes the following, who are employed by the PRP for the amounts of time outlined in §§B — D of this regulation: (1) A program director; (2) A psychiatric rehabilitation specialist; and (3) Psychiatric rehabilitation direct care staff. B. If a PRP has fewer than 30 enrollees, the PRP shall employ either: (1) A program director and a psychiatric rehabilitation specialist, each of whom is employed by the program for a minimum of 20 hours per week; or (2) A program director who is responsible for the duties of the program director and the duties of a psychiatric rehabilitation specialist, if the program director: (a) Has the qualifications described under Regulation .10B(1) of this chapter; (b) Is employed by the program for 40 hours per week; and (c) Devotes at least 20 hours per week to the development and implementation of rehabilitation services that reflect the needs of the individuals served by the program. C. If a PRP has 30 — 100 enrollees, the PRP shall employ either: (1) A program director and a psychiatric rehabilitation specialist, each of whom is employed by the program for a minimum of 20 hours per week, and one of whom is employed for an additional 20 hours; or (2) A program director who is responsible for the duties of the program director and the duties of the psychiatric rehabilitation specialist, if the program director: (a) Has the qualifications described under Regulation .10B(1) of this chapter; (b) Is employed by the program for 40 hours per week; and (c) Designates staff to devote 20 hours per week to carrying out specific assigned administrative duties. D. If a PRP has more than 100 enrollees, the PRP program shall employ: (1) A program director who is employed for 40 hours per week; and (2) A psychiatric rehabilitation specialist or specialists and staff assigned to administrative duties as follows: (a) A psychiatric rehabilitation specialist who is on site 40 hours per week; (b) Two psychiatric rehabilitation specialists, each of whom is on site for 20 hours per week; or (c) If the program director has the qualifications described under Regulation .10B(1) of this chapter: (i) A psychiatric rehabilitation specialist who is employed 20 hours per week; and (ii) Staff designated to devote 20 hours per week carrying out specific assigned administrative duties. #### Regulation .12 Ratio. *COMAR 10.21.21.12* A. The program shall maintain an average ratio of at least one rehabilitation staff member serving each ten individuals who are receiving on-site PRP services, or receiving off-site PRP services in a group. B. To achieve this ratio, the program: (1) May not include: (a) The program director; or (b) Consultants and volunteers; and (2) May include students only if, in calculating the ratio, five rehabilitation staff are on duty for each student. #### Regulation .13 Volunteers and Students. *COMAR 10.21.21.13* A. Students. The program may use students according to the provisions of COMAR 10.21.17.12E. B. Volunteers. The program may use volunteers according to the provisions of COMAR 10.21.17.12F. ### Chapter 22 — Community Mental Health Programs — Residential Rehabilitation Programs **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .12 adopted as an emergency provision effective January 16, 1995 (21:26 Md. R. 2183); adopted permanently effective April 24, 1995 (22:8 Md. R. 596) **Administrative History:** Chapter revised effective November 30, 1998 (25:24 Md. R. 1774) **Administrative History:** Regulation .07B amended effective October 17, 2011 (38:21 Md. R. 1278) #### Regulation .01 Scope. *COMAR 10.21.22.01* A. The purpose of this chapter is to outline the site, staffing, and service requirements that a psychiatric rehabilitation program (PRP) shall fulfill in order to be eligible to be approved to provide residential rehabilitation program (RRP) services. B. The Department may approve a program as an RRP if the applicant: (1) Is approved by the Department under COMAR 10.21.21; (2) Leases or owns at least one residence to be operated under the requirements of this chapter; and (3) For a residence of four or more individuals, holds a license under COMAR 10.21.04. #### Regulation .02 Definitions. *COMAR 10.21.22.02* In this chapter, terms have the meanings stated in COMAR 10.21.17. #### Regulation .03 Application and Initial Approval Process. *COMAR 10.21.22.03* A. Consultation. Before submitting an application, a PRP that is applying for approval to operate an RRP may request assistance regarding the proper compilation of application materials and completion of the application from the Administration or the appropriate: (1) Core service agency (CSA) director; or (2) Residential specialist. B. Program Application. A PRP that is applying for approval to operate an RRP shall include with the application for program approval under COMAR 10.21.16.03B: (1) A description of the type of service that the program intends to provide, including: (a) An estimate of the total number of individuals to be served by the RRP; and (b) The capacity of the RRP to provide general or intensive staffing, as defined in Regulation .09D of this chapter; and (2) A copy of the residential specialist's certificate of approval of the residence, as granted under the provisions of §C(4)(a)(i) of this regulation. C. Initial Approval of a Residence. (1) Application for Approval of a Residence. A PRP that is applying for approval of a residence as a component of an RRP or an applicant for licensure of a group home under COMAR 10.21.04 shall submit to the residential specialist an application that: (a) Is on the form approved by the Department with the requirement that all questions be answered and all required documents be attached; (b) Includes documentation: (i) That the residence is or will be owned or leased by the applicant; (ii) Of fire, liability, and hazard insurance coverage on the building in which the residence is located; and (iii) Of compliance with relevant federal, State, or local ordinances, laws, regulations, and orders, including zoning and safety, that are applicable to housing for individuals without disabilities. (2) Review of Application. Within 5 working days of receipt of an application for approval of an RRP residence, the residential specialist shall review the application for completeness, and if the application is: (a) Complete, arrange with the applicant to inspect the residence; or (b) Incomplete, promptly return it to the applicant with written instructions regarding proper completion of the application. (3) Initial Inspection of Residence. Within 10 working days of receipt of a completed application, in collaboration with a representative of the applicant, the residential specialist, using the residential checklist, shall inspect the residence for compliance with Regulation .05 of this chapter. (4) Initial Certification of a Residence by a Residential Specialist. (a) Based on the inspection conducted under §C(3) of this regulation, within 5 working days of the inspection, the residential specialist shall issue to the applicant, with copies to the Administration and CSA, one of the following: (i) A certificate of general approval of the residence; (ii) Notice of provisional approval, based on noncompliance with specific site requirements under Regulation .05 of this chapter; or (iii) Notice that the residence is not approved, based on noncompliance with specific site requirements under Regulation .05 of this chapter. (b) If the residential specialist issues a notice under §C(4)(a)(ii) or (iii) of this regulation, the residential specialist shall, at the applicant's request: (i) Evaluate the applicant's efforts to attain compliance; and (ii) If necessary, reinspect the residence. (c) Following an evaluation under §C(4)(b) of this regulation, the residential specialist shall issue one of the following: (i) A certificate of general approval of the residence; (ii) Notice of continued provisional approval; or (iii) Notice of denial of approval, advising the applicant of hearing rights, as provided in COMAR 10.21.16.11 or COMAR 10.21.04.06G, as applicable. #### Regulation .04 Process for Annual Approval of a Residence. *COMAR 10.21.22.04* A. Annual Review of a Residence. Within not more than 1 year from the date of the last certificate of approval of a residence, the residential specialist, using the residential checklist, shall: (1) Conduct an on-site evaluation to: (a) Inspect the residence for continued compliance with: (i) The documentation required under Regulation .03C(1)(b) of this chapter; and (ii) Site requirements outlined in Regulation .05 of this chapter, using the residential checklist; (b) Document residents' assessment of the residence and of services described in Regulations .05, .08, and .09 of this chapter through face-to-face interviews, in an RRP residence of: (i) One to three residents, with at least one individual; or (ii) Four or more residents, with at least 30 percent of the individuals living in the residence; and (c) Verify, when appropriate: (i) Residents' collection of entitlements; and (ii) The program's fee collections; (2) Based on the inspection conducted under §A(1)(a) of this regulation, issue the certification or notice described in Regulation .03C(4)(a) of this chapter to the RRP program director, with copies to the: (a) PRP program director; and (b) Director of the CSA; and (3) Notify the RRP program director, in writing, of significant information collected under §A(1)(b) or (c) of this regulation. B. Notice of Noncompliance with Site Requirements. If the residential specialist finds that the residence is not in compliance with a site requirement or requirements outlined in Regulation .05 of this chapter, the residential specialist shall: (1) If the deficiency does not pose an imminent risk to the health, safety, or welfare of an individual served: (a) Give the RRP program director written notice of provisional approval, identifying the deficiency and the time frame, of not more than 30 days, to correct the deficiency; and (b) If necessary, reinspect the residence to determine compliance; (2) If the deficiency poses a risk to the health, safety, or welfare of an individual served; (a) Give the RRP program director written notice that the Department intends not to approve the residence, citing the reason for the disapproval, with copies to the: (i) PRP program director; and (ii) Director of the CSA; and (b) Request corrective action within 24 hours; (3) If the deficiency cited under: (a) §B(1) of this regulation is within 30 days: (i) Corrected, issue a certificate of general approval; or (ii) Not corrected, reevaluate the approval status of the residence and provide that information to the Department's designated approval unit for consideration when evaluating the approval status of the RRP; and (b) Section B(2) of this regulation is not corrected within 24 hours, give the RRP program director, with copies to the PRP program director and Director of the CSA, written notice of: (i) The emergency suspension of the approval of the residence, under State Government Article, §10-226, Annotated Code of Maryland; (ii) Hearing rights, as provided in COMAR 10.21.16.11; and (iii) The obligation to relocate residents according to the provisions of §C of this chapter. C. Relocation of Residents. If approval of a residence is suspended under the provisions of §B(3)(b) of this regulation, the RRP director shall relocate residents according to the plan adopted under Regulation .05D of this chapter. D. Extension of Approval Status of a Residence. If the residential specialist does not complete a site inspection before an on-site review by the Department's designated approval unit, the Secretary shall maintain the RRP's existing approval status, pending receipt of the residential specialist's determination of approval status of a residence or residences. #### Regulation .05 Site Requirements. *COMAR 10.21.22.05* A. General Requirements. The RRP director shall ensure that: (1) All areas of a residence, including storage areas, are safe, clean, and free of hazards and clutter; (2) A residence has: (a) No housing code or zoning violations; (b) Working smoke alarms or smoke detectors that meet local fire codes for residential dwellings; (c) Hot and cold running water and adequate light, heat, and ventilation; and (d) Sufficient, appropriate, and functional furnishings, equipment, supplies, and utensils comparable to those found in the residences of nondisabled individuals; (3) A resident: (a) Has the resources to purchase or has access to food: (i) For at least three meals per day for 7 days each week; and (ii) That meets the individual's dietary, nutritional, and religious needs; (b) Has the resources to acquire an adequate supply of soap, towels, and toilet tissue; (c) Who self-administers medication, has access to a secure storage area for the individual's medications; (d) Has access to a secure storage area for funds and valuables; (e) Has access to transportation; (f) Has access to a telephone in the residence; and (g) To the extent possible, may use personal possessions and preferences in furnishing and decorating the resident's space; and (4) The following emergency procedures are in place: (a) Posted near the telephone are telephone numbers for the: (i) Fire department, police, ambulance, and poison control center; and (ii) Program's on-call staff; and (b) An emergency evacuation procedure that is explained to and practiced by residents within 10 days of residence and, at a minimum, every 3 months after that. B. Bedrooms. The RRP director shall ensure that a bedroom has: (1) A minimum of 70 square feet for a single bedroom and a minimum of 120 square feet for a double bedroom; (2) A door, except for an efficiency apartment; (3) Closet space for each individual in or convenient to each bedroom; (4) Window covering for privacy; (5) A bed with a clean mattress and pillow; (6) At least two sets of linens per individual; and (7) Not more than two residents. C. Toilet and Bathing Areas. The RRP director shall ensure that: (1) The residence has a minimum of one full bathroom for every four residents; (2) A full bathroom includes at least one toilet, one basin, and one tub or shower connected to hot and cold water; (3) Bathrooms are easily accessible and conveniently located, not more than one floor level from living, dining, and sleeping rooms; and (4) Bathrooms provide for individual privacy. D. Relocation Plan. Each program shall have a written relocation plan that: (1) Specifies where residents may live temporarily if the residential specialist determines that conditions in the approved residence pose an imminent risk to the health, safety, or welfare of a resident; (2) Is approved by the CSA; (3) Is updated annually; and (4) Is submitted to the residential specialist. #### Regulation .06 Residential Rehabilitation Program Model. *COMAR 10.21.22.06* A. The RRP director shall organize, maintain, and develop: (1) Policies directed to ensure the provision of flexible services which respond to the current needs of an individual in an RRP; and (2) Services that: (a) Promote the individual's ability to engage and participate in appropriate community activities; and (b) In a supportive environment, enable the individual to develop the daily living skills needed for independent functioning. B. The RRP director shall ensure that the residential rehabilitation program: (1) Is located in the community, unless given an exemption by the CSA; (2) Offers a home-like environment; and (3) Provides goal-directed PRP services that facilitate rehabilitation and integration into community life. #### Regulation .07 Eligibility, Screening, and Enrollment. *COMAR 10.21.22.07* A. An RRP shall conduct eligibility review, screening, and enrollment according to the provisions of COMAR 10.21.21.04. B. If the RRP residence is a group home that is licensed under COMAR 10.21.04, the RRP shall admit residents according to the additional limitations outlined under COMAR 10.21.04.03B and C. #### Regulation .08 Evaluation and Planning Services. *COMAR 10.21.22.08* A. Assessment. Within 30 days of initiation of RRP services, staff, in collaboration with the individual, shall complete an RRP assessment that includes: (1) The rehabilitation service requirements noted in the PRP assessment; and (2) An assessment of the individual's: (a) Need for RRP services; (b) Behaviors, if any, that are potentially dangerous to self or others; (c) Ability to perform basic self-care and to maintain personal safety; (d) History, if any, of requiring intermittent intensive levels of support in order to remain in the community; and (e) Need for changing intensity of intervention based on the episodic nature of illness. B. Individualized Rehabilitation Plan (IRP). (1) Initial IRP. Within 30 days of initiation of RRP services and based on the assessment in §A of this regulation, staff shall specify in the IRP: (a) RRP goals; and (b) The range of: (i) Frequency of residential services; and (ii) Intensity of staff support, as described in Regulation .09D of this chapter. (2) If the individual's service needs change, the RRP staff shall: (a) Provide and document in the individual's record the services required by the change; (b) Notify relevant staff of the change initiated; and (c) Incorporate this information in the next IRP review. (3) IRP Review. As frequently as necessary, as determined by an individual's rehabilitation coordinator, and at a minimum of every 6 months, the rehabilitation coordinator shall: (a) Review and record in the individual's medical record: (i) The individual's progress toward the accomplishment of previously identified rehabilitation goals; (ii) Goal changes, based on a review of the individual's progress; and (iii) Changes in interventions, including staff responsibility; (b) Communicate promptly the results of the IRP review to: (i) Relevant program staff; and (ii) With proper consent, family or significant others designated by the individual, and community mental health programs providing services to the individual. (4) Signature of the IRP and Reviews. Staff shall obtain the individual's written or tape-recorded agreement or disagreement with the plan and, in addition, the following shall sign the plan and reviews: (a) The rehabilitation coordinator; and (b) Staff responsible for implementing the plan. C. Continuing Evaluation. The RRP director shall ensure that RRP staff document in the individual's PRP record contact notes and, at least monthly, progress summary notes of services, including any change in intensity of staff support, delivered at the RRP. D. Documentation. RRP staff shall document the assessment, IRP, contact notes, and progress summary notes for residential services in either: (1) The PRP record; or (2) In documents separate from the PRP record, if the PRP record references the separate documents. #### Regulation .09 Residential Rehabilitation and Support Services Provided. *COMAR 10.21.22.09* In addition to the provision of PRP services, the RRP program director shall ensure that: A. RRP services support the program model outlined in Regulation .06 of this chapter; B. Staff provide an appropriate range of services: (1) Based on the assessment under Regulation .08A of this chapter; and (2) In a flexible manner, as needed by the individual; C. Appropriate staff maintain linkage, as described in COMAR 10.21.21.06F, with a resident who is in a psychiatric inpatient facility or detention center; and D. Staff support, based on the program description as referenced in Regulation .03B(1) of this chapter, is provided at the level indicated by the individual's need, as follows: (1) General support, which provides that, at a minimum, staff: (a) Are available, on call, 24 hours per day, 7 days per week; and (b) Have at least one face-to-face contact per individual per week; or (2) Intensive support, which provides that staff are available, on site, for: (a) Daily support for a specific number of individuals; and (b) A minimum of 40 hours per week for up to 24 hours per day, 7 days per week. #### Regulation .10 Discharge, Suspension, and Discontinuation of Residential Services. *COMAR 10.21.22.10* A. Discharge Policy. The program director shall: (1) Collaborate with the Administration's administrative services organization (ASO) to: (a) Arrange for discharge from the program when services are no longer authorized by the Administration's ASO; and (b) Discontinue residential services to an individual whose clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others; (2) Maintain clearly written policies and procedures for: (a) The process for discharge from the program; and (b) Temporary suspension from a residence; and (3) Discontinue residential services to an individual whose clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others, including the: (a) Criteria for discontinuation; and (b) Progressive steps and interventions that the program will enact before discontinuation. B. Collaborative Discharge. When the Administration's ASO, in consultation with the rehabilitation coordinator, determines that services are no longer medically necessary, the rehabilitation coordinator shall follow the provisions for collaborative discharge outlined in COMAR 10.21.21.07B. C. Suspension. (1) If an individual's clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others, the RRP program director may ask the individual to leave the residence on a temporary basis, as an alternative to the individual's termination from the residence. (2) To implement a suspension identified in §C(1) of this regulation, the RRP program director: (a) In writing, shall inform: (i) The individual of the suspension and the reason for the determination; and (ii) When involved and with proper consent, the CSA and the Administration's ASO of the suspension; (b) Shall give information on placement alternatives; and (c) May provide temporary housing options. D. Program's Recommendation to Discontinue Residential Services. If the program director recommends discontinuing residential services to an individual whose clinical needs exceed the RRP's ability to secure the safety and welfare of the individual or others, the program director shall: (1) Provide written notice of the discontinuation, according to the provisions of COMAR 10.21.21.07D; (2) When possible, give the individual information about appropriate alternative services; (3) When authorized, arrange for outreach, by PRP staff, to encourage the individual to access appropriate services; and (4) Complete a discharge summary in accordance with COMAR 10.21.17.07D(3). #### Regulation .11 RRP Staff. *COMAR 10.21.22.11* A. RRP Program Director. The PRP program director shall either: (1) Carry out the RRP program director's duties that are delineated in this chapter; or (2) Appoint an RRP program director with the qualifications outlined in COMAR 10.21.21.08C. B. RRP Staff. The RRP program director shall ensure the deployment of sufficient staff to carry out the RRP: (1) Model described in Regulation .06 of this chapter; (2) Activities outlined in the individual's IRPs; and (3) Staff support outlined in Regulation .09D of this chapter. #### Regulation .12 Quality Management (QM). *COMAR 10.21.22.12* A. In addition to the QM requirements in COMAR 10.21.17.10, annually the RRP program director shall complete and document reviews of the RRP's staff support, as described in Regulation .09D of this chapter, to evaluate the relationship between staff deployment and the: (1) Number of: (a) Admissions to inpatient psychiatric facilities; (b) Visits to emergency departments; and (c) Suspensions and terminations; and (2) Results of the program's risk management (RM) analysis conducted under the provisions of COMAR 10.21.17.10C(3). B. The RRP program director shall evaluate the results of the interviews conducted by the residential specialist under the provisions of Regulation .04A(1) of this chapter and, when appropriate, modify the RRP services being delivered. C. The RRP program director shall notify the CSA director of the results of the analysis conducted under §A(1) of this regulation. ### Chapter 23 — Community-Based Fund **Authority:** Health-General Article, §10-208, Annotated Code of Maryland **Administrative History:** Effective date: October 23, 1995 (22:21 Md. R. 1616) **Administrative History:** Regulation .02B amended effective February 9, 1998 (25:3 Md. R. 145) **Administrative History:** Regulation .03C amended effective February 9, 1998 (25:3 Md. R. 145) #### Regulation .01 Scope. *COMAR 10.21.23.01* This chapter establishes the process for deposits to and disbursements from a community-based fund that is established when a ward is closed at a State inpatient facility. #### Regulation .02 Definitions. *COMAR 10.21.23.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Mental Hygiene Administration. (2) “Admission” means that an individual is: (a) Taken into observation status on the basis of certification for involuntary admission under Health-General Article, §§10-614 — 10-617, Annotated Code of Maryland, and COMAR 10.21.01.07; or (b) Voluntarily admitted under the provisions of Health-General Article, §10-609 or 10-610, Annotated Code of Maryland. (3) “Average annual itemized expenses” means the amount budgeted for institutional services and administrative overhead costs that are appropriated for the facility in the fiscal year in which downsizing occurs. (4) “Core service agency (CSA)” means the county or multicounty authority, designated under Health-General Article, Title 10, Subtitle 12, Annotated Code of Maryland, and approved by the Department, that is responsible for planning, managing, and monitoring publicly funded mental health services. (5) “Department” means the Maryland Department of Health. (6) “Director” means the Director of the Maryland Department of Health. (7) “Downsizing” means the process by which the Administration analyzes the projected capacity of a State inpatient facility and implements procedures to close a ward or wards. (8) “Fund” means the Mental Hygiene Community-Based Services Fund established according to the requirements of Health-General Article, §10-208, Annotated Code of Maryland. (9) “Secretary” means the Secretary of Health. (10) “State inpatient facility” means a facility listed in Health-General Article, §10-406(a), Annotated Code of Maryland. #### Regulation .03 Planning. *COMAR 10.21.23.03* A. The Administration shall identify annually the number and size of wards, if any, marked for closure at each State inpatient facility. B. The Administration may use State general funds that are appropriated in advance to assist in downsizing. C. In planning for the provision of appropriate treatment and support services in the community, if the jurisdictions to which individuals discharged from the closing wards are: (1) Served by a core service agency (CSA) or agencies, the Administration shall collaborate with the appropriate CSA; or (2) Not served by a CSA, the Administration, in collaboration with the local health officer, shall carry out the necessary planning. #### Regulation .04 Deposits to the Fund. *COMAR 10.21.23.04* A. When the Administration determines to close a ward or wards of a facility, the Administration shall assure that savings resulting from the downsizing are used as provided under Regulation .05 of this chapter. B. In depositing to the Fund, the Administration shall follow the following process: (1) Calculate the net daily cost of maintaining an individual in the facility by: (a) Subtracting from the facility's total general fund appropriation: (i) Average annual itemized expenses for costs that are required to continue to provide care, treatment, and support services; (ii) Cost for new admissions to the facility under Health-General Article, Title 10, Subtitle 6, Annotated Code of Maryland; and (iii) Cost for court-ordered evaluations and commitments to the facility under Health-General Article, Title 12, Annotated Code of Maryland; and (b) Dividing the net result under §B(1)(a) of this regulation by the average patient population of the facility, to arrive at the net facility cost per individual per day; (2) According to the planning process under Regulation .03C of this chapter, determine the community cost per individual per day of providing appropriate treatment and mental health support services; (3) Subtract from the facility cost per individual per day yielded under §B(1) of this regulation the community cost per individual per day yielded under §B(2) of this regulation to yield the savings per individual per day; (4) Multiply the savings per individual per day under §B(3) of this regulation by the capacity of the ward or wards closed to arrive at the total savings per day; and (5) For the fiscal year that the ward is closed, deposit to the Fund the prorated amount, based on the total savings per day under §B(4) of this regulation, multiplied by the number of days that the ward is vacated. #### Regulation .05 Disbursements from the Fund. *COMAR 10.21.23.05* A. The Administration shall ensure that the first priority for disbursements from the Fund is for the care and treatment of individuals discharged from the closed ward or wards. B. The Administration may not use the Fund to supplant State general fund resources for existing community services. C. Disbursements from the Fund, in excess of the amount required to annualize the cost of care and treatment of individuals discharged from the closed ward or wards, are subject to the State appropriations process. D. The Director shall ensure that the Fund is used to provide needed services in the community, including but not limited to: (1) Case management; (2) Crisis services; (3) Outpatient mental health clinic; (4) Psychiatric day treatment; (5) Group home placement; (6) Mobile treatment services; (7) Psychiatric rehabilitation; (8) Residential rehabilitation; (9) Supported employment; (10) Supported living; (11) Therapeutic group homes; and (12) Consumer-operated programs. E. Portions of the Fund that are unspent at the end of a fiscal year, and earned interest, shall remain in the Fund to be used for the purposes specified in this regulation. #### Regulation .06 Reporting. *COMAR 10.21.23.06* A. On or before January 1 of each year, the Secretary shall prepare a report on the Fund to be submitted to the General Assembly and the Department of Fiscal Services. B. The Secretary shall include in the report: (1) The number and capacity of State inpatient facility wards closed during the prior fiscal year; (2) An accounting of: (a) The amount deposited to the Fund according to the methodology outlined under Regulation .04 of this chapter, and (b) All other amounts reallocated from facilities to community programs; (3) An accounting of disbursements from the Fund in accordance with Regulation .05 of this chapter; and (4) The number and capacity of State inpatient facility wards planned for closure during the current fiscal year. ### Chapter 24 — Interagency Discharge Planning for Hospitalized Children and Adolescents **Authority:** Article 49D, §4, Annotated Code of Maryland **Administrative History:** Effective date: May 5, 1997 (24:9 Md. R. 657) #### Regulation .01 Incorporation by Reference. *COMAR 10.21.24.01* COMAR 01.04.03 is incorporated by reference. ### Chapter 25 — Fee Schedule — Mental Health Services — Community-Based Programs and Individual Practitioners **Authority:** Health-General Article, §§10-901, 15-103, and 15-105; Title 16, Subtitles 1 and 2; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .08 adopted as an emergency provision effective July 1, 1997 (24:18 Md. R. 1293); adopted permanently effective October 20, 1997 (24:21 Md. R. 1449) **Administrative History:** Chapter revised as an emergency provision effective July 1, 1998 (25:14 Md. R. 1123) **Administrative History:** Chapter revised effective October 1, 1998 (25:18 Md. R. 1435 and 25:19 Md. R. 1506) **Administrative History:** Chapter revised as an emergency provision effective March 1, 2000 (27:4 Md. R. 451); revised permanently effective June 26, 2000 (27:12 Md. R. 1139) **Administrative History:** Regulation .01D amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .02B amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .02B amended as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); amended permanently effective October 27, 2003 (30:21 Md. R. 1529) **Administrative History:** Regulation .04A, B amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .05A, D amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .06A amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .09A, B amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .10A, D amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .11A amended as an emergency provision effective July 1, 2002 (29:24 Md. R. 1915); amended permanently effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulation .14 adopted as an emergency provision effective July 1, 2003 (30:17 Md. R. 1202); adopted permanently effective October 27, 2003 (30:21 Md. R. 1529) **Administrative History:** Chapter revised as an emergency provision effective February 1, 2004 (31:5 Md. R. 446); revised permanently effective June 7, 2004 (31:11 Md. R. 857) **Administrative History:** Regulation .08B amended effective December 19, 2005 (32:25 Md. R. 1942) **Administrative History:** Regulation .08H adopted effective December 19, 2005 (32:25 Md. R. 1942) **Administrative History:** Chapter revised as an emergency provision effective July 1, 2006 (33:15 Md. R. 1274); emergency status extended at 34:4 Md. R. 397; revised permanently effective February 26, 2007 (34:4 Md. R. 400) **Administrative History:** Regulations .02, .03, and .05 — .10 amended as an emergency provision effective July 1, 2008 (35:21 Md. R. 1822) **Administrative History:** Regulations .02, .03, and .05 — .10 amended as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); amended permanently effective March 23, 2009 (36:6 Md. R. 491) **Administrative History:** Regulation .03 amended effective January 2, 2017 (43:26 Md. R. 1445) **Administrative History:** Regulation .03B amended effective January 7, 2013 (39:26 Md. R. 1664); February 3, 2014 (41:2 Md. R. 91) **Administrative History:** Regulation .03-1 adopted as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); adopted permanently effective March 23, 2009 (36:6 Md. R. 491) **Administrative History:** Regulation .03-1 amended effective June 27, 2011 (38:13 Md. R. 755) **Administrative History:** Regulation .03-2 adopted as an emergency provision effective December 22, 2008 (36:2 Md. R. 97); emergency status expired June 19, 2009 **Administrative History:** Regulation .03-2 amended effective January 7, 2013 (39:26 Md. R. 1664); February 3, 2014 (41:2 Md. R. 91) **Administrative History:** Regulations .05 — .11 amended as an emergency provision effective July 1, 2007 (34:17 Md. R. 1506); amended permanently effective October 8, 2007 (34:20 Md. R. 1739) **Administrative History:** Regulation .05 — .11 amended effective January 7, 2013 (39:26 Md. R. 1664); February 3, 2014 (41:2 Md. R. 91) **Administrative History:** Regulation .08 amended effective June 27, 2011 (38:13 Md. R. 755) **Administrative History:** Regulation .08C amended effective January 2, 2017 (43:26 Md. R. 1445) **Administrative History:** Regulation .09I adopted as an emergency provision effective October 20, 2009 (36:24 Md. R. 1855); adopted permanently effective February 8, 2010 (37:3 Md. R. 176) **Administrative History:** Regulation .09I amended effective June 27, 2011 (38:13 Md. R. 755); December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .09J adopted effective December 11, 2014 (41:24 Md. R. 1427) **Administrative History:** Regulation .11 amended effective February 3, 2014 (41:2 Md. R. 91) **Administrative History:** Regulation .12 adopted effective February 3, 2014 (41:2 Md. R. 91) **Administrative History:** Regulation .13 adopted effective February 3, 2014 (41:2 Md. R. 91) #### Regulation .01 Scope. *COMAR 10.21.25.01* This chapter establishes the fees that the Department reimburses for mental health services that are rendered by a provider to an individual who receives Medicaid-reimbursable or State-supported services. #### Regulation .02 General Reimbursement. *COMAR 10.21.25.02* A. The Department shall reimburse the lower of the amount billed or the fee established under this chapter, after the application of an individual's copayment, based on the ability-to-pay determination according to Regulation .03 of this chapter. B. The Department may reimburse for non-Medicaid-reimbursable mental health services to the extent that State resources permit. C. According to the provisions of this chapter, the Department shall reimburse a mental health services provider: (1) That is: (a) A community-based mental health program that is approved by the Department; or (b) An appropriately credentialed individual practitioner who contracts with the Department's Medical Assistance Program; (2) For specific services that are delivered to: (a) Medicaid recipients; or (b) Individuals for whom, because of the severity of their mental illness and their financial need, the cost of mental health services is subsidized, in whole or in part, by State general funds for services not reimbursed under a grant or a contract. D. This chapter does not establish fees for services that are provided by: (1) A federally qualified health center; (2) An inpatient facility regulated by the Health Services Cost Review Commission, to an inpatient or resident of the facility; or (3) A home health agency licensed under COMAR 10.09.04. E. The mental health service provider shall bill services using: (1) The procedural terminology codes contained in the most current Physician's Current Procedural Terminology (CPT) manual published by the American Medical Association and incorporated by reference in COMAR 10.09.09.07D; and (2) If there is no current CPT code for the service, a customized code published by the Administration. F. The mental health service provider, by submitting a claim for reimbursement for service, certifies that the service is medically necessary, has been delivered and meets the description and intent of the CPT code which is contained on its claim for reimbursement. G. Medicare Recipients. (1) If a provider renders services to individuals who are Medicare recipients, the provider shall comply with all federal Medicare requirements. (2) If a provider does not comply with all Medicare requirements, the provider may not seek reimbursement by the PMHS. #### Regulation .03 Definitions. *COMAR 10.21.25.03* A. In this chapter, terms have the meanings stated in COMAR 10.21.17, COMAR 10.63.01.02, and this regulation. B. Terms Defined. (1) “Ability-to-pay schedule” means the schedule adopted, according to the provisions of Health-General Article, Title 16, Subtitle 2, Annotated Code of Maryland, by the Secretary to evaluate and establish the extent of a consumer's ability to pay for services rendered. (2) “Administration” means the Behavioral Health Administration. (2-1) “Assertive Community Treatment Program (ACT)” means an evidence-based practice program approved by the Administration under its regulations. (3) “Core service agency (CSA)” has the meaning stated in COMAR 10.63.01.02. (3-1) “Day habilitation” has the meaning stated in COMAR 10.09.46. (3-2) “Emergency department” means an organized hospital-based facility that provides unscheduled episodic services, 24 hours per day, 7 days per week, to individuals who present for immediate medical attention. (4) Emergency Service. (a) “Emergency service” means a service that is provided to an individual who presents a danger to the life or safety of the individual or another. (b) “Emergency service” does not include a residential or mobile crisis service. (5) “Enhanced support” means short-term, in-home services, in addition to other services to an individual, provided by a program to support the individual to remain in the community: (a) For mobile treatment services: (i) Under COMAR 10.21.19 if approved; and (ii) Under COMAR 10.63.03.04 if licensed; (b) For adult psychiatric rehabilitation services: (i) Under COMAR 10.21.21 if approved; and (ii) Under COMAR 10.63.03.09 if licensed; or (c) For outpatient mental health services; (i) Under COMAR 10.21.20 if approved; and (ii) Under COMAR 10.63.03.05 if licensed. (5-1) “Evidence-based practice (EBP)” is an Administration-approved practice that applies to certain clinical or rehabilitative interventions provided by public mental health service providers. (5-2) “Family psychoeducation” is an evidence-based practice approved by the Administration under its regulations. (6) “Fee” means the dollar amount, established by the Secretary, that a provider may charge an individual who receives services under this chapter for a unit of service, before the application of an ability-to-pay determination. (7) “Individual practitioner” means: (a) A marriage and family therapist who is licensed and legally authorized to practice clinical marriage and family therapy in the state in which the service is rendered; (b) A nurse psychotherapist who is: (i) Licensed and legally authorized to practice as a nurse psychotherapist in the state in which the service is rendered; and (ii) Certified by the Maryland Board of Nursing or an equivalent board of nursing in another state as a nurse psychotherapist, and demonstrates, by training and experience, the competency to provide the mental health services; (c) A certified registered nurse practitioner psychiatric mental health (CRNP-PMH) who is: (i) Licensed and legally authorized to practice as a certified registered nurse practitioner — psychiatric in the state in which the service is rendered to perform independently the services set forth in COMAR 10.27.07; and (ii) Certified by the Maryland Board of Nursing or an equivalent board of nursing in another state as a certified registered nurse practitioner with a specialty in psychiatry pursuant to COMAR 10.27.07 and demonstrates, by training and experience, the competency to provide the mental health services; (d) An occupational therapist who: (i) Is licensed and legally authorized to practice as an occupational therapist in the state in which the service is rendered, and (ii) Demonstrates, by training and experience, the competency to provide mental health services; (e) A physician who: (i) Is licensed and legally authorized to practice as a physician in the state in which the service is rendered, and (ii) Demonstrates, by training and experience, the competency to provide mental health services; (f) A professional counselor who is licensed and legally authorized to practice as a clinical professional counselor in the state in which the service is rendered; (g) A psychologist who: (i) Is licensed and legally authorized to practice as a psychologist in the state in which the service is rendered, and (ii) Demonstrates, by training and experience, the competency to provide mental health services; or (h) A social worker who is licensed and legally authorized to practice as a clinical social worker in the state in which the service is rendered. (7-1) “Intensive outpatient services” means services that are delivered to an individual by a multidisciplinary team for a minimum of 3 hours of therapeutic activities, including at least two group therapies. (7-2) “Level I” means a level of service provided to an individual who is enrolled in the Traumatic Brain Injury Waiver Program, based on the requirements for intensity of services and staffing outlined in: (a) For individuals receiving residential habilitation services, COMAR 10.09.46.07D(2); (b) For individuals receiving day habilitation services, COMAR 10.09.46.08F(2); and (c) For individuals receiving supported employment services, COMAR 10.09.46.09C(2). (7-3) “Level II” means a level of service provided to an individual who is enrolled in the Traumatic Brain Injury Waiver Program, based on the requirements for intensity of services and staffing outlined in: (a) For individuals receiving residential habilitation services, COMAR 10.09.46.07D(3); (b) For individuals receiving day habilitation services, COMAR 10.09.46.08F(3); and (c) For individuals receiving supported employment services, COMAR 10.09.46.09C(3). (7-4) “Level III” means a level of service provided to an individual who is enrolled in the Traumatic Brain Injury Waiver Program, based on the requirements for intensity of services and staffing outlined in: (a) For individuals receiving residential habilitation services, COMAR 10.09.46.07D(4); (b) For individuals receiving day habilitation services, COMAR 10.09.46.08F(4); and (c) For individuals receiving supported employment services, COMAR 10.09.46.09C(4). (7-5) “Local behavioral health authority (LBHA)” has the meaning stated in COMAR 10.63.01.02. (8) Mental Health Program. (a) “Mental health program” means a program that provides a plan of mental health treatment or mental health rehabilitation, consisting of various therapeutic modalities, that is: (i) Approved by the Department under this subtitle or COMAR 10.09 to be eligible to receive State or federal funds; and (ii) Provided in the community. (b) “Mental health program” includes: (i) Non-hospital-based partial hospitalization (psychiatric day treatment) services under COMAR 10.21.02 if approved, and COMAR 10.63.03.08 if licensed; (ii) Therapeutic nursery programs under COMAR 10.21.18; (iii) Mobile treatment services under COMAR 10.21.19 if approved, and COMAR 10.63.03.04 if licensed; (iv) Outpatient mental health clinic (OMHC) services under COMAR 10.21.20 if approved, and COMAR 10.63.03.05 if licensed; (v) Psychiatric rehabilitation programs for adults under COMAR 10.21.21 if approved, and COMAR 10.63.03.09 if licensed, including supported living services; (vi) Residential rehabilitation programs under COMAR 10.21.22 if approved, and COMAR 10.63.04.05 if licensed; (vii) Home health services under COMAR 10.09.04; (viii) Supported employment programs under COMAR 10.21.28 if approved, and COMAR 10.63.03.16 if licensed; (ix) Respite care programs under COMAR 10.21.27 if approved, and COMAR 10.63.03.15 if licensed; (x) Residential crisis services programs under COMAR 10.21.26 if approved, and COMAR 10.63.04.04 if licensed; and (xi) Therapeutic and psychiatric rehabilitation services for minors under COMAR 10.21.29 if approved, and COMAR 10.63.03.10 if licensed. (9) Mobile Treatment. (a) “Mobile treatment” means a program approved under COMAR 10.21.19, or licensed under COMAR 10.63.03.04. (b) “Mobile treatment” does not include transporting an individual to a program site to receive services. (10) Off-Site. (a) “Off-site” means a location, other than a site defined in §B(11) of this regulation, to which mental health program staff travels to provide services to an individual. (b) “Off-site” includes, with respect to psychiatric rehabilitation program services, those services delivered to an individual: (i) In the individual's home, including a residential rehabilitation program residence; (ii) At a job site; or (iii) At another community location appropriate to the individual's needs. (c) “Off-site” does not include: (i) A juvenile detention center; or (ii) Any facility or group home that is licensed to provide rehabilitative or therapeutic services, or living skills. (11) “On-site” means a mental health program facility or other site to which a program has access and at which the program regularly delivers services to individuals who come to the site for the services. (11-1) Other Mental Health Professional. (a) “Other mental health professional” means an individual who is licensed, certified, or otherwise legally authorized to independently provide the mental health service. (b) “Other mental health professional” includes a: (i) Licensed certified social worker — clinical; (ii) Nurse psychotherapist; (iii) Licensed clinical professional counselor; (iv) Licensed clinical marriage and family therapist; or (v) Certified registered nurse practitioner — psychiatric mental health (CRNP-PMH). (12) “Outpatient mental health clinic (OMHC)” means a program approved under COMAR 10.21.20 or licensed under COMAR 10.63.03.05. (13) “Partial hospitalization program” means a program approved under COMAR 10.21.02 or licensed under COMAR 10.63.03.08. (14) “Program” means a mental health program as defined in §B(8) of this regulation. (15) “Provider” means: (a) A community-based mental health program as defined in §B(8) of this chapter; or (b) An individual practitioner as defined in §B(7) of this chapter. (16) “Psychiatric rehabilitation program for adults (PRP)” means a program approved under COMAR 10.21.21 or licensed under COMAR 10.63.03.09. (16-1) “Residential crisis services (RCS)” means a program approved under COMAR 10.21.26 or licensed under COMAR 10.63.04.04. (16-2) “Residential habilitation” has the meaning stated in COMAR 10.09.46. (17) “Residential rehabilitation program (RRP)” means a program approved under COMAR 10.21.22 or licensed under COMAR 10.63.04.05. (17-1) “Respite care” means services that are approved under COMAR 10.21.27 or licensed under COMAR 10.63.03.15 (18) “Secretary” means the Secretary of Health (19) “Serious emotional disturbance” means a condition that is: (a) Manifest in an individual younger than 18 years old; (b) Diagnosed according to a current diagnostic and statistical manual of the American Psychiatric Association that is recognized by the Secretary, excluding the following, unless it coexists with a diagnosable psychiatric disorder: (i) Developmental disorder; (ii) Substance abuse; and (iii) Disorder classified under the “V” code; and (c) Characterized by a functional impairment that substantially interferes with or limits the child's role or functioning in the family, school, or community activities, including the following: (i) Inability to achieve or maintain one or more developmentally appropriate social, behavioral communicative, or adaptive skills; or (ii) Episodic, recurrent, and continuous functional impairments. (20) “Serious and persistent mental disorder” means a disorder that is: (a) Manifest in an individual 18 years old or older; (b) Diagnosed, according to a current diagnostic and statistical manual of the American Psychiatric Association that is recognized by the Secretary, as: (i) Schizophrenic disorder; (ii) Major affective disorder; (iii) Other psychotic disorder; or (iv) Borderline or schizotypal personality disorders, with the exclusion of an abnormality that is manifested only by repeated criminal or otherwise antisocial conduct; and (c) Characterized by impaired role functioning, on a continuing or intermittent basis, for at least 2 years, including at least three of the following: (i) Inability to maintain independent employment; (ii) Social behavior that results in intervention by the mental health system; (iii) Inability, due to cognitive disorganization, to procure financial assistance to support living in the community; (iv) Severe inability to establish or maintain a personal social support system; (v) Need for assistance with basic living skills. (21) “Therapeutic and psychiatric rehabilitation services for minors” means a program approved under COMAR 10.21.29 or licensed under COMAR 10.63.03.10. #### Regulation .03-1 General Reimbursement Conditions. *COMAR 10.21.25.03-1* A. Claims Submission. In order to be reimbursed by the Department, an approved provider shall submit a claim when the provider has: (1) Obtained authorization to provide the services for which the claim is being submitted; (2) Delivered the service; (3) Documented provision of service as required; and (4) Complied with any regulatory preconditions for the delivery of the service. B. Claims Retraction. The Department may retract any payments made to any PMHS provider for paid claims if an audit indicates that: (1) The services were not provided; (2) The services were not medically necessary; (3) There is no documentation that the services were provided; (4) The precondition for the delivery of the service was not met; or (5) The provider failed to comply with §H of this regulation. C. If the Department retracts funds from a provider under §B of this regulation, within 30 days following the retraction the Department shall provide notice and an opportunity for a hearing. D. Limitations. (1) The Department shall reimburse, for services delivered on the same service date for the same individual, an outpatient mental health center (OMHC) for a maximum of two therapy sessions subject to the following conditions: (a) Only one may be an individual therapy session; (b) Only one may be a group therapy session; and (c) Only one may be a family therapy session, either with or without the individual. (2) The Department may not reimburse an OMHC for the following services delivered to the same individual on the same service date: (a) Individual therapy with medication management session, and medication management session; (b) Diagnostic interview or assessment, and a treatment planning session; and (c) A diagnostic interview or assessment, and a therapy session. (3) For all other providers, the Department shall reimburse for only one service per service date. (4) Limitations Exception. The Department may provide an exception to the limitation rule on outpatient services if the ASO finds that the service: (a) Is medically necessary; (b) Is not duplicative; and (c) Has been preauthorized. E. The Department shall reimburse Psychiatric Rehabilitation Program services provided to a child residing in a therapeutic group home, as defined in COMAR 10.21.07 when the TGH certifies that its negotiated rate does not include payment for the PRP services. F. The Department may not reimburse outpatient mental health services provided to an individual when the individual is in a hospital or residential treatment center. G. The Department may not reimburse PRP providers until the PRP has met the minimum service encounters as defined in Regulation .09 of this chapter. H. For individual practitioners, when services are preauthorized, the following documentation is required before submitting for payment for services rendered: (1) For each individual served, the medical record, which shall include the following documentation: (a) A signed consent to treatment; (b) A comprehensive assessment that includes the: (i) Individual or family’s presenting problem; (ii) Individual or family’s history; (iii) Individual’s diagnosis; and (iv) Rationale for the diagnosis; and (c) An individualized treatment plan that includes the: (i) Problems, needs, strengths, and goals that are measurable; (ii) Interventions that are medically necessary; and (iii) Signatures of the individual, or if the individual is a minor, the guardian, and the treating mental health professional; and (2) Progress notes for each face-to-face contact including: (a) Date of service; (b) Start time and end time; (c) Location; (d) Summary of interventions provided; and (e) The treating mental health professional’s signature and date of service. I. Services rendered by an individual practitioner may only be reimbursed for the licensed mental health professionals authorized by the practice board to diagnose and treat psychiatric disorders as identified in this chapter of regulations. #### Regulation .03-2 Supplemental Rates. *COMAR 10.21.25.03-2* Providers who billed for services rendered from July 1, 2013 until the effective date of these regulations may resubmit their claims and be reimbursed for these services as set forth in Regulations .05 — .12 of this chapter. #### Regulation .04 Ability to Pay. *COMAR 10.21.25.04* A. Except if an individual is a Medicaid recipient: (1) A provider shall provide to the Administration's designee the information needed to assess an individual's ability to pay; (2) The Administration's designee shall assess the individual's ability to pay and determine the required copayment; and (3) The provider shall make collections of the copayment according to the requirements in Health-General Article, §§16-201 — 16-204, Annotated Code of Maryland. B. The Department shall furnish to a provider, on request, an ability-to-pay schedule, including periodic updates. #### Regulation .05 Fee Schedule — Treatment Services — Diagnosis and Therapy. *COMAR 10.21.25.05* A. Diagnostic Interview. The Department shall reimburse a provider for a face-to-face diagnostic interview, as follows: (1) For a child or adolescent, when rendered by a provider with demonstrated competency to provide mental health services to children or adolescents: (a) OMHC ... $190.23; (b) Physician ... $151.68; (c) Psychologist ... $121.08; (d) Other mental health professionals ... $106.01; (2) For an adult: (a) OMHC ... $170.32; (b) Physician ... $151.68; (c) Psychologist ... $121.08; (d) Other mental health professional ... $106.01. B. Individual Therapy. The Department shall reimburse a provider for an individual therapy session, as follows: (1) For a child or adolescent, when rendered by a provider with demonstrated competency to provide mental health services to children or adolescents: (a) For 30 minutes: (i) OMHC ... $59.19; (ii) Physician ... $50.05; (iii) Psychologist ... $40.09; (iv) Other mental health professional ... $34.98; (b) For 20 — 30 minutes, with biofeedback training: (i) OMHC ... $50.05; (ii) Physician ... $50.05; (iii) Psychologist ... $40.09; (iv) Other mental health professional ... $34.98; (c) For 45 minutes: (i) OMHC ... $105.20; (ii) Physician ... $90.94; (iii) Psychologist ... $72.65; (iv) Other mental health professional ... $63.77; (d) For 45 — 50 minutes, with biofeedback training: (i) OMHC ... $90.94; (ii) Physician ... $90.94; (iii) Psychologist ... $72.65; (iv) Other mental health professional ... $63.77; (e) For 60 minutes in an OMHC ... $105.20; (2) For an adult: (a) For 30 minutes: (i) OMHC ... $50.05; (ii) Physician ... $50.05; (iii) Psychologist ... $40.09; (iv) Other mental health professional ... $34.98; (b) For 20 — 30 minutes, with biofeedback training: (i) OMHC ... $50.05; (ii) Physician ... $50.05; (iii) Psychologist ... $40.09; (iv) Other mental health professional ... $34.98; (c) For 45 minutes: (i) OMHC ... $90.94; (ii) Physician ... $90.94; (iii) Psychologist ... $72.65; (iv) Other mental health professional ... $63.77; (d) For 45 — 50 minutes, with biofeedback training: (i) OMHC ... $90.94; (ii) Physician ... $90.94; (iii) Psychologist ... $72.65; (iv) Other mental health professional ... $63.77; (e) For 60 minutes in an OMHC ... $90.94. C. Family Therapy. The Department shall reimburse a provider for a family therapy session, as follows: (1) When the identified patient is a child or adolescent and the service is rendered by a provider with demonstrated competency to provide mental health services to children or adolescents: (a) Without the identified patient: (i) OMHC ... $104.13; (ii) Physician ... $85.02; (iii) Psychologist ... $69.96; (iv) Other mental health professional ... $53.81; (b) With the identified patient, for 20 — 30 minutes: (i) OMHC ... $58.65; (ii) Physician ... $58.65; (iii) Psychologist ... $46.82; (iv) Other mental health professional ... $41.17; (c) With the identified patient, for 45 — 60 minutes: (i) OMHC ... $107.62; (ii) Physician ... $94.71; (iii) Psychologist ... $76.41; (iv) Other mental health professional ... $65.64; (2) When the identified patient is an adult: (a) Without the identified patient for 45 — 60: (i) OMHC ... $90.14; (ii) Physician ... $85.02; (iii) Psychologist ... $69.96; (iv) Other mental health professional ... $53.81; (b) With the identified patient, for 45 — 60 minutes: (i) OMHC ... $94.71; (ii) Physician ... $94.71; (iii) Psychologist ... $76.41; (iv) Other mental health professional ... $65.64. D. Group Therapy. The Department shall reimburse a provider for each individual, up to a maximum of 10, in a group therapy session as follows: (1) When the identified patient is a child or adolescent and the service is rendered by a provider with demonstrated competency to provide mental health services to children or adolescents: (a) For 45 — 60 minutes: (i) OMHC ... $40.90; (ii) Physician ... $24.75; (iii) Psychologist ... $24.75; (iv) Other mental health professional ... $24.75; (b) For more than 75 minutes in an OMHC ... $50.58; (2) When the identified patient is an adult: (a) For 45 — 60 minutes: (i) OMHC ... $38.74; (ii) Physician ... $24.75; (iii) Psychologist ... $24.75; (iv) Other mental health professional ... $24.75; (b) For more than 75 minutes in an OMHC ... $50.58. #### Regulation .06 Fee Schedule — Additional Treatment Services. *COMAR 10.21.25.06* A. Psychological Testing. The Department shall reimburse a psychologist for conducting psychological testing, up to a maximum of 8 hours per year per individual as follows: (1) OMHC psychologist ... $99.02 per hour; (2) Other psychologist ... $99.02 per hour; (3) OMHC psychologist associate ... $27.55 per hour; (4) Other psychologist associate ... $27.55 per hour. B. Occupational Therapy. The Department shall reimburse an occupational therapist for providing services, as follows: (1) To an individual, payable in 15-minute increments, for face-to-face: (a) Therapeutic activities ... $11.83 per 15 minutes; (b) Self-care, home management training ... $11.83 per 15 minutes; (c) Community and work reintegration ... $11.83 per 15 minutes; (d) Development of cognitive skills ... $11.83 per 15 minutes; (e) Occupational therapy evaluation and re-evaluation ... $15.07 per 15 minutes; (2) For each individual, up to a maximum of 10, in a group therapy session of a minimum of 60 minutes ... $18.30. C. Physician Services. The Department shall reimburse for services rendered to a child, adolescent, or adult, by an appropriately privileged physician or certified registered nurse practitioner — psychiatric only, as follows: (1) The patient's primary care physician in an inpatient or partial hospital setting: (a) Initial care: (i) For a minimum of 30 minutes ... $108.43; (ii) For a minimum of 50 minutes ... $147.19; (iii) For a minimum of 70 minutes ... $216.47; (b) Subsequent care: (i) For a minimum of 15 minutes ... $41.71; (ii) For a minimum of 25 minutes ... $76.73; (iii) For a minimum of 35 minutes ... $110.63; (c) Discharge day management: (i) For 30 minutes or less ... $77.68; (ii) For more than 30 minutes ... $114.63; (d) For discharge data submission ... $21.53; (e) For individual therapy, in an inpatient setting: (i) For 30 minutes ... $43.78; (ii) For 45 minutes ... $82.30; (2) The patient's primary certified registered nurse practitioner — psychiatric, in an inpatient or partial hospital setting: (a) Initial care: (i) For a minimum of 30 minutes ... $108.43; (ii) For a minimum of 50 minutes ... $147.19; (iii) For a minimum of 70 minutes ... $216.47; (b) Subsequent care: (i) For a minimum of 15 minutes ... $41.71; (ii) For a minimum of 25 minutes ... $76.73; (iii) For a minimum of 35 minutes ... $110.63; (c) Discharge day management: (i) For 30 minutes or less ... $77.68; (ii) For more than 30 minutes ... $114.63; (d) For individual therapy, in an inpatient setting: (i) For 30 minutes ... $30.65; (ii) For 45 minutes ... $57.61; (3) For electroconvulsive therapy, in an inpatient setting: (a) Including monitoring ... $98.39; (b) Anesthesia ... $98.27; (4) A consultant physician, or a consultant certified registered nurse practitioner — psychiatric, in an inpatient or partial hospital setting, initial consult, for a minimum of: (a) 20 minutes ... $51.66; (b) 40 minutes ... $79.60; (c) 55 minutes ... $121.30; (d) 80 minutes ... $174.86; (e) 110 minutes ... $217.80; (5) A consultant physician or a consultant certified registered nurse practitioner — psychiatric, in an outpatient setting: (a) For a minimum of 15 minutes ... $51.49; (b) For a minimum of 30 minutes ... $96.74; (c) For a minimum of 40 minutes ... $131.91; (d) For a minimum of 60 minutes ... $194.98; (e) For a minimum of 80 minutes ... $237.73; #### Regulation .07 Fee Schedule — Special OMHC Services. *COMAR 10.21.25.07* A. Treatment Planning. The Department shall reimburse an OMHC for providing an OMHC-enrolled individual with one face-to-face treatment planning meeting every 6 months, at the rate of $82.87 per planning meeting. B. Multifamily Group Therapy. The Department shall reimburse an OMHC for providing multifamily group therapy, with the identified patient, for families of: (1) Children and adolescents, for 45 — 60 minutes, with the child present ... $41.98 per family; (2) Children and adolescents, for 20 — 30 minutes, with the child present ... $38.55 per family; (3) Adults, for 45 — 60 minutes, with the adult present ... $39.83 per family; (4) Adults, for 20 — 30 minutes, with the adult present ... $35.75 per family; C. Family Psychoeducation. The Department shall reimburse a provider, when the provider has been approved by the Administration to provide evidence-based services, for a family psychoeducation session with or without the identified adult, at a rate of $53.81 per family. D. Prolonged Services. The Department shall reimburse an OMHC for providing, on-site, prolonged services, face-to-face with the identified patient, as follows: (1) For 30 — 74 minutes ... $106.79; (2) For an additional period of 30 minutes ... $104.10. E. Venipuncture and Injection. The Department shall reimburse an OMHC for providing: (1) Routine venipuncture ... $14.94; (2) Therapeutic injection ... $14.94. F. Intensive Outpatient Services. The Department shall reimburse an OMHC for providing intensive outpatient services, when the services are delivered by a multidisciplinary team for a minimum of 3 hours of therapeutic activities, including needed physician services and at least two group therapies, as follows: (1) For children or adolescents ... $154.17 per day; (2) For adults ... $129.69 per day. G. Discharge Data Submission. The Department shall reimburse an OMHC $21.53 for discharge data submission. #### Regulation .08 Fee Schedule — Treatment Services — Programs. *COMAR 10.21.25.08* A. Therapeutic Nursery Programs. The Department shall reimburse a program approved under COMAR 10.21.18 to provide therapeutic nursery services to eligible children, younger than 5 years old, at a rate of $42.20 per day, for a minimum of 3 days per week, 3 hours per day. B. Mobile Treatment Services. The Department shall reimburse a program for mobile treatment services delivered to an individual: (1) For a minimum of four face-to-face services, and according to a treatment plan that outlines the expected type and frequency of services; (2) At the rate of: (a) $839.45 per month; or (b) If the individual is a Medicare recipient, $643.58 per month, if the program has: (i) Delivered services according to the provision of §A(1) of this regulation; and (ii) Billed applicable Medicare reimbursed services; (3) For enhanced support, when the need for short-term one-to-one support is documented and approved by the Administration or its designee: (a) At the rate of $12.91 per hour; (b) Up to a maximum of $129.10 per day; (c) Not to exceed 30 days per calendar year. (4) For evidence-based programs, assertive community treatment (ACT), at the rate of: (a) For Medicaid recipients and other individuals meeting eligibility criteria for uninsured, $1,183.34 per month; or (b) If the individual has Medicare only, $1,049.31 per month. C. Partial Hospitalization. For programs approved under COMAR 10.21.02 or licensed under COMAR 10.63.03.08, the Department shall reimburse: (1) A non-hospital-based partial hospitalization (psychiatric day treatment) program, for services provided to an eligible Medicaid recipient: (a) For a full day, a minimum of 6.5 hours of therapeutic activities per day ... $203.68 per day; (b) For a half day, or intensive, outpatient services, when the services are delivered by a multidisciplinary team, for a minimum of 4 hours of therapeutic activities, including at least two group therapies ... $110.85 per day; (2) HSCRC programs that meet the minimum requirements of COMAR 10.21.02, at the rate established by the HSCRC; (3) OMHC, for intensive outpatient services provided to a Medicaid recipient in a psychiatric day treatment program: (a) For adults ... $129.69; (b) For children and adolescents ... $154.17; and (4) For physician services, at the rates established under Regulation .06D of this chapter. D. The Department may not reimburse a partial hospitalization program (psychiatric day treatment) or an OMHC intensive outpatient mental health program on the same day that an intensive outpatient program or service is provided for substance abuse treatment. E. Residential Crisis Services. The Department shall reimburse a provider for residential crisis services delivered to an individual, as follows: (1) As an alternative to inpatient admission or to shorten the length of inpatient stay: (a) For clinical services ... $252.34 per day; (b) For room and board ... $12.59 per day; (2) Treatment foster care ... $162.25 per day; and (3) For physician services, at the rates established for services rendered to an individual in an inpatient setting under Regulation .05D of this chapter. #### Regulation .09 Fee Schedule — Support Services. *COMAR 10.21.25.09* A. Psychiatric Rehabilitation Program (PRP) Services. The Department shall reimburse a PRP for providing face-to-face rehabilitation services to an individual with a serious emotional disturbance (SED) or serious and persistent mental disorder (SPMD), by a monthly rate that is based on a minimum and maximum range of services, when the PRP submits monthly supporting encounter data after services are provided to the individual, within which the provider shall meet the needs of the individual, as follows: (1) Assessment ... $61.62; (2) PRP services to an employed individual in a supported employment program, delivered at the job site, at a rate of $107.62 per month, for: (a) A minimum of two services per month; (b) A maximum of 30 services per month; (c) A minimum of 15 minutes per service; and (d) A maximum of one service per day. B. Additional PRP Services. In addition to the services outlined in §A of this regulation, the Department shall reimburse a PRP for providing face-to-face rehabilitation services to an individual with SED or SPMD by a monthly rate that is based on a minimum and maximum range of services, within which the provider shall meet the needs of the individual, as follows: (1) PRP Community Psychiatric Support Services delivered to an individual with an SED or an SPMD, whose functioning is severely impaired, and who is living with a parent, guardian, or relative who is legally responsible for the individual's care, as follows: (a) When on-site and off-site services are delivered to an individual by one PRP, $426.99 per month for: (i) A minimum of three and a maximum of 30 services per month, on-site or off-site; (ii) On-site services, at a minimum of 60 minutes per service; (iii) Off-site services, at a minimum of 15 minutes per service; and (iv) A maximum of one on-site or one off-site service per day; or (b) When on-site and off-site services are delivered to an individual by two PRPs, a PRP may receive reimbursement for either on-site or off-site services, but not both, as follows: (i) On-site services, at a rate of $183.22 per month, for a minimum of two services and a maximum of 30 services per month, at a minimum of 60 minutes per service; (ii) Off-site services, at a rate of $243.76 per month, for a minimum of two services and a maximum of 30 services per month, at a minimum of 15 minutes per service; and (iii) Limited to reimbursement for one on-site and one off-site service per day; (2) PRP supported living for services delivered to an individual with an SED or an SPMD, whose functioning is severely impaired, and who is living independently or with individuals who are not legally responsible for their care, as follows: (a) When services are delivered to an individual by one PRP, $760.88 per month as follows: (i) A minimum of six and a maximum of 30 services per month, on-site or off-site; (ii) On-site services, at a minimum of 60 minutes per service; (iii) Off-site services, at a minimum of 15 minutes per service; and (iv) Limited to one on-site and off-site service per day; or (b) When on-site and off-site services are delivered to an individual by two PRPs, a PRP may receive reimbursement for either on-site or off-site services, but not both, as follows: (i) On-site services, at a rate of $259.37 per month, for a minimum of three services and a maximum of 30 services per month, at a minimum of 60 minutes per service; (ii) Off-site services, at a rate of $501.51 per month, for a minimum of five services and a maximum of 30 services per month and a minimum of 15 minutes per service; and (iii) Limited to reimbursement for one on-site or off-site service per day; (3) PRP services delivered to individuals in residential rehabilitation programs (RRPs) as follows: (a) General support: (i) On-site, at a rate of $447.70 per month, for a minimum of four services, up to 30 services per month, at a minimum of 60 minutes per service; (ii) Off-site, at a rate of $1,202.13 per month, for a minimum of 13 services, up to 30 services per month, at a minimum of 15 minutes per service; or (iii) Any combination of on-site or off-site PRP services, at a rate of $1,649.83 per month, for a minimum of 17 services, up to 30 services per month, at a minimum of 30 minutes per service; or (b) Intensive support: (i) On-site, at a rate of $447.70 per month, for a minimum of four services, up to 30 services per month, at a minimum of 60 minutes per service; (ii) Off-site, at a rate of $3,123.17 per month, for a minimum of 19 services, up to 30 services per month, at a minimum of 15 minutes per service; or (iii) Any combination of on-site or off-site PRP services, at a rate of $3,570.87 per month, for a minimum of 23 services, up to 30 services per month, at a minimum of 30 minutes per service; or (4) PRP services delivered to individuals when transitioning from inpatient level of care to the community, any combination of on-site or off-site PRP services, at a rate of $447.70 per month, for a minimum of 4 services, up to 30 services per month, at a minimum of 60 minutes per service. C. RRP Services. The Department shall reimburse an RRP for providing services to an individual with a serious and persistent mental disorder and whose functioning is severely impaired, as follows: (1) Room and board ... $12.59 per day; (2) A provider may collect additional fees from an individual not covered by the rate established in §B(1) of this regulation to cover a portion of costs of food, shelter, and other household expenses associated with an individual's basic needs in an RRP residence, not to exceed the provider's cost of care. D. Mental Health Vocational Programs (MHVP). The Department shall reimburse a program that is approved for mental health vocational services for providing supported employment services to an individual with a mental disorder: (1) If the service is authorized by the Administration or its designee; (2) If the program documents an individual's application to the Division of Rehabilitation Services (DORS) and has documentation of the decision on the application; and (3) At the following rates, per individual approved for supported employment services: (a) Completion of vocational assessment, individual supported employment plan, referral to DORS, and education regarding entitlements and work incentives, not more than three times per year ... $430.49; (b) Job placement of the individual, not more than three times per year ... $1,075.14; (c) Intensive job coaching, if not otherwise reimbursed, at a maximum of $7.40 per 15 minutes, up to a lifetime maximum of $2,750 per individual; and (d) Extended MHVP support ... $349.77 per month. E. Mental Health Vocational Programs — Evidence-Based Programs. The Department shall reimburse an MHVP evidence-based program: (1) If the service is authorized by the Administration or its designee; (2) If the program documents an individual's application to the Division of Rehabilitation Services (DORS) and has documentation of the decision on the application; and (3) At the following rates, per individual approved for supported employment services: (a) Completion of vocational assessment, individual supported employment plan, referral to DORS, and education regarding entitlements and work incentives not more than three times per year ... $430.49; (b) Job placement of the individual not more than three times per year ... $1,075.14; (c) Intensive job coaching, if not otherwise reimbursed, at a maximum of $7.40 per 15 minutes, up to a lifetime maximum of $2,750.00 per individual; (d) Clinical service coordination at a rate of $107.62 per month, that is documented and includes, with the individual's consent, at a minimum: (i) Monthly collaboration with the individual's treatment or psychiatric rehabilitation team; and (ii) Face-to-face contact every 6 months with the individual's treating clinician or psychiatrist; and (e) Extended PRP support to an individual in a supported employment program at a rate of $430.49 per month for: (i) A minimum of three services per month; (ii) A maximum of 30 services per month; (iii) A minimum of 15 minutes per service; and (iv) A maximum of one service per day. F. Respite Care. The Department shall reimburse a program that is approved for respite care for providing services to a child or adolescent with a serious emotional disturbance, whose functioning is severely impaired, or an adult with a serious and persistent mental disorder, whose functioning is severely impaired, as follows: (1) For children: (a) General support in a facility ... $174.34 per day; or (b) In-home respite, when the need for short-term, one-to-one support is documented or for in-home respite and approved by the CSA up to a maximum of 10 hours per day at a rate of ... $3.49 per 15 minutes; (2) For adults, general support in a residential rehabilitation program ... $75.61 per day. G. Enhanced Support. When the need for short-term, one-to-one support is documented and approved by the CSA, the Department shall reimburse an OMHC, PRP, RRP, or MTS for providing services to a child or adolescent with an SED or an adult with an SPMD, and whose functioning is seriously impaired, at the rate of $12.91 per hour up to a maximum of $129.10 per day, not to exceed 30 days per year. H. Therapeutic Behavioral Services. The Department shall reimburse a therapeutic behavioral services provider, as defined in COMAR 10.09.34, as follows: (1) One-to-one behavioral aide services to a child or adolescent ... $5.39 per 15 minutes; (2) Initial assessment and development of a behavioral plan ... $105.51; (3) Reassessment and development of a new behavioral plan ... $99.18. I. Adult Mental Health Case Management. The Department shall reimburse a designated program that is approved by the Core Service Agency for mental health case management according to COMAR 10.09.45 for providing case management services to an adult with a serious and persistent mental health disorder as follows: (1) Assessment ... $108.61; (2) Case Management Service units, for a minimum of 60 minutes of face-to-face and non-face-to-face case management service at a rate of $108.61 per day for: (a) General level up to 2 units per month; or (b) Intensive level up to 5 units per month; and (3) When an individual is referred to case management by the Administration or its designee, and is transitioning from an institute for mental disease or hospital, one transitional visit at a rate of $159.55. J. Mental Health Case Management: Care Coordination for Children and Youth. The Department shall reimburse a designated program that is approved by the Core Service Agency to provide mental health case management services to a child or adolescent with a serious emotional disorder, according to COMAR 10.09.90, as follows: (1) Case Management Service units, for a minimum of 15 minutes of face-to-face and non-face-to-face case management service at a rate of $20.19 per 15 minutes for: (a) Level I — General Coordination up to 12 units of service per month, with a minimum of two units of face-to-face contact; (b) Level II — Moderate Care Coordination up to 30 units of service per month, with a minimum of four units of face-to-face contact; and (c) Level III — Intensive Care Coordination up to 60 units of service per month, with a minimum of six units of face-to-face contact; and (2) For comprehensive assessment and reassessment case management service units, for Level I and Level II only, four additional face-to-face units of service above the monthly maximum may be billed during the first month of service to the participant and every 6 months thereafter. #### Regulation .10 Fee Schedule — Services — Traumatic Brain Injury (TBI) Waiver Program. *COMAR 10.21.25.10* A. Residential Habilitation Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide residential habilitation services to an individual who is enrolled in the TBI Waiver Program: (1) At the following rates: (a) Level I ... $192.76 per day; (b) Level II ... $255.24 per day; (c) Level III ... $353.11 per day; (2) According to the need for the level of support documented in an individual's waiver plan of care and approved by the Administration; and (3) According to the institutional level of care determined by the Department's utilization control agent. B. Day Habilitation Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide day habilitation services to an individual who is enrolled in the TBI Waiver Program: (1) At the following rates: (a) Level I ... $49.76 per day; (b) Level II ... $86.81 per day; (c) Level III ... $122.14 per day; (2) According to the need for the level of support documented in an individual's waiver plan of care and approved by the Administration; and (3) According to the institutional level of care determined by the Department's utilization control agent. C. Supported Employment Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide supported employment services to an individual who is enrolled in the TBI Waiver Program: (1) At the following rates: (a) Level I ... $29.53 per day; (b) Level II ... $49.76 per day; (c) Level III ... $122.14 per day; (2) According to the need for the level of support documented in an individual's waiver plan of care and approved by the Administration; and (3) According to the institutional level of care determined by the Department's utilization control agent. D. Individual Support Services. The Department shall reimburse a program approved under COMAR 10.09.46 to provide individual support services, as defined in COMAR 10.22.07, to an individual who is enrolled in the TBI Waiver Program at a rate of $24.14 per hour, not to exceed 8 hours per day. #### Regulation .11 Fee Schedule — Services — Emergency Department. *COMAR 10.21.25.11* The Department shall reimburse an emergency department for providing emergency mental health services to an individual who is enrolled in the public mental health system, for services rendered by an appropriately privileged physician or certified registered nurse practitioner — psychiatric as follows: A. For a problem focused history, a problem focused examination, and straightforward medical decision making ... $22.27; B. For an expanded problem focused history, an expanded problem focused examination, and medical decision making of low complexity ... $43.80; C. For an expanded problem focused history, an expanded problem focused examination, and medical decision making of moderate complexity ... $65.29; D. For a detailed history, a detailed examination, and medical decision making of moderate complexity ... $124.63; E. For a comprehensive history, a comprehensive examination, and medical decision making of high complexity ... $182.80. #### Regulation .12 Evaluation and Management Services — Including Medication Management. *COMAR 10.21.25.12* A. New Patients. The Department shall reimburse for evaluation and management services for new patients, including medication management: (1) For a problem focused history, or a problem focused examination, and straightforward medical decision making of minor complexity: (a) OMHC ... $48.70; (b) Physician ... $48.70; (c) Certified registered nurse practitioner — psychiatric ... $48.70; (2) For an expanded problem focused history, or an expanded problem focused examination, and straightforward medical decision making: (a) OMHC ... $82.48; (b) Physician ... $82.48; (c) Certified registered nurse practitioner — psychiatric ... $82.48; (3) For a detailed history, or a detailed examination, and medical decision of low complexity: (a) OMHC ... $119.25; (b) Physician ... $119.25; (c) Certified registered nurse practitioner — psychiatric ... $119.25; (4) For a comprehensive history, or a comprehensive medical examination, with medical decision making of moderate complexity: (a) OMHC ... $181.64; (b) Physician ... $181.64; (c) Certified registered nurse practitioner — psychiatric ... $181.64; (5) For a comprehensive history, or a comprehensive medical examination, with medical decision making of high complexity: (a) OMHC ... $224.53; (b) Physician ... $224.53; (c) Certified registered nurse practitioner — psychiatric ... $224.53. B. Established Patients. The Department shall reimburse for evaluation and management services for established patients, including medication management: (1) For a history, or examination, where presenting problems are minimal, and straightforward medical decision making of minor complexity: (a) OMHC ... $22.72; (b) Physician ... $22.72; (c) Certified registered nurse practitioner — psychiatric ... $22.72; (2) For a problem focused history, or a problem focused examination, and straightforward medical decision making: (a) OMHC ... $48.70; (b) Physician ... $48.70; (c) Certified registered nurse practitioner — psychiatric ... $48.70; (3) For an expanded history, or an expanded examination, and medical decision of low complexity: (a) OMHC ... $80.11; (b) Physician ... $80.11; (c) Certified registered nurse practitioner — psychiatric ... $80.11; (4) For a detailed history, or a detailed medical examination, with medical decision making of moderate complexity: (a) OMHC ... $117.60; (b) Physician ... $117.60; (c) Certified registered nurse practitioner — psychiatric ... $117.60; (5) For a comprehensive history, or a comprehensive medical examination, with medical decision making of high complexity: (a) OMHC ... $157.64; (b) Physician ... $157.64; (c) Certified registered nurse practitioner — psychiatric ... $157.64. #### Regulation .13 Crisis Therapy. *COMAR 10.21.25.13* The Department shall reimburse an OMHC for crisis therapy, as follows: A. For a child or adolescent, when rendered by a provider with demonstrated competency to provide mental health services to children or adolescents: (1) For the first 60 minutes ... $118.37; (2) For an additional period of 30 minutes ... $61.77; B. For an adult: (1) For the first 60 minutes ... $100.10; (2) For an additional period of 30 minutes ... $54.16. ### Chapter 26 — Community Mental Health Programs — Residential Crisis Services **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: December 28, 1998 (25:26 Md. R. 1926) **Administrative History:** Regulation .02B amended as an emergency provision effective June 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 13, 2007 (34:16 Md. R. 1432) **Administrative History:** Regulation .03C amended as an emergency provision effective June 1, 2007 (34:13 Md. R. 1149); amended permanently effective August 13, 2007 (34:16 Md. R. 1432) #### Regulation .01 Scope. *COMAR 10.21.26.01* This chapter outlines the staffing and service requirements for a provider of residential crisis services. #### Regulation .02 Definitions. *COMAR 10.21.26.02* A. In this chapter, terms have the meanings stated in COMAR 10.21.17 and this regulation. B. Term Defined. “Residential crisis services (RCS)” means intensive mental health and support services that are: (1) Provided to a child or an adult with mental illness who is experiencing or is at risk of a psychiatric crisis that would impair the individual's ability to function in the community; and (2) Designed to prevent a psychiatric inpatient admission, provide an alternative to psychiatric inpatient admission, shorten the length of inpatient stay, or reduce the pressure on general hospital emergency departments. #### Regulation .03 Approval. *COMAR 10.21.26.03* The Department shall grant approval to a program to be eligible to receive State or federal funds for providing RCS if the program: A. Meets the requirements: (1) For approval outlined in COMAR 10.21.16; (2) For administration outlined in COMAR 10.21.17; and (3) Of this chapter, including approval, based on the requirements for intensity of services and staffing outlined in this chapter, for one or more of the following: (a) Inpatient admission prevention; (b) Inpatient admission alternative; or (c) Treatment foster care in a foster home licensed under COMAR 07.02.21; B. For a program that provides RCS to a child, documents State licensure for the location in which the child will be housed while receiving crisis services; and C. For a program that provides services to an adult: (1) Documents State licensure for the location in which the individual will be housed while receiving crisis services; (2) Meets the residential site requirements outlined under COMAR 10.21.22, as documented by the residential specialist; or (3) Is located in subacute beds in an inpatient psychiatric facility. #### Regulation .04 Program Model. *COMAR 10.21.26.04* A. A provider of RCS shall assure that services are: (1) Therapeutic; (2) Provided by staff who, as determined by the program, are appropriately credentialed and privileged; (3) Available: (a) 24 hours per day, 7 days per week; (b) On a short-term basis, as needed to resolve an immediate crisis; and (c) At a location in the community, unless given a written exemption from the core service agency (CSA). B. A provider of RCS shall assure that services are adequate to support one or more of the following levels of service: (1) Inpatient admission prevention, which provides: (a) Services to an individual who, based on the individual's history, as evaluated by a physician or a mental health professional, has a mental disorder and, without RCS, is at risk for inpatient admission or cannot be discharged from an inpatient facility; and (b) Staff adequate to support the services under §B(1)(a) of this regulation, as outlined under Regulations .08 and .09 of this chapter; (2) Inpatient admission alternative, which provides: (a) Services to an individual who, based on an evaluation by a physician or a mental health professional, has a mental disorder, presents a danger to self or others, and would, without RCS, be admitted to or could not be discharged from an inpatient facility; and (b) Staff adequate to support the services under §B(2)(a) of this regulation, as outlined under Regulations .08 and .10 of this chapter, including access to a psychiatrist 24 hours per day, 7 days per week; or (3) Treatment foster care, which provides: (a) Services to an individual who, based on an evaluation by a physician or mental health professional, has a mental disorder, and is in need of a high level of treatment intervention in a family setting; and (b) Staff adequate to support services under §B(3)(a) of this regulation, as outlined under Regulations .08 and .11 of this chapter. C. A provider of RCS shall assure that services are designed to: (1) Avert or shorten the length of inpatient admissions; (2) Defuse a current crisis, evaluate the nature of the crisis, stabilize the individual to the pre-crisis level of functioning, and intervene to reduce the likelihood of crisis recurrence; (3) Assist the individual and members of the individual's natural support system to recognize and take preventive action to resolve situations that lead to crisis; (4) Provide counseling, training, and support for crisis prevention, identification, and intervention for individuals and, if appropriate, their families; (5) Link individuals with services and supports in the community including, but not limited to, financial, educational, social, medical, and mental health resources that will enable the individual to: (a) Return to the individual's previous living situation; or (b) Secure an alternative living situation; and (6) Offer a home-like environment that provides goal-directed services to facilitate safe discharge from residential crisis services. D. A provider of RCS shall assure that services are coordinated with, when appropriate: (1) An individual's custodial agents; (2) Designated psychiatric emergency facilities; (3) Psychiatric inpatient facilities; (4) Psychiatric rehabilitation programs; (5) Outpatient mental health clinics; (6) Somatic care providers; (7) Schools; (8) Other agencies involved with the individual, including, but not limited to: (a) Local departments of social services; (b) Department of Juvenile Services; (c) The local education authority; (d) The local coordinating council (LCC); (e) The local management board; and (f) Criminal justice agencies; and (9) Other public and private providers of mental health services to an individual. #### Regulation .05 Eligibility, Referral, Screening, and Admission. *COMAR 10.21.26.05* A. Eligibility and Referral. (1) An individual is eligible for RCS if: (a) The individual: (i) Is a participant, as described in COMAR 10.21.25.01D(2), in the public mental health system; (ii) Has a diagnosis that is listed in COMAR 10.09.70.02; (iii) Due to acute symptomatology related to the individual's psychiatric condition, has impaired ability to function within the individual's community living situation and is in need of RCS to avoid inpatient psychiatric admission or to shorten the length of inpatient stay; (iv) For clinical reasons, requires a temporary separation from the individual's current living situation; (v) Has stated a willingness to comply with program rules, or, for a child, a parent or guardian has stated a willingness to comply with program rules; (vi) Expects, with staff support, to be able to comply with treatment recommendations; and (vii) Is able, with staff support, to care for physical needs and basic personal hygiene; and (b) The services are preauthorized, as needed, by the Administration's administrative services organization (ASO) according to the provisions of COMAR 10.21.17.02-1A. (2) An individual is not eligible for RCS if the individual: (a) Has a sole diagnosis of substance abuse, mental retardation, or dementia; (b) Is in need of immediate involuntary inpatient psychiatric admission; (c) As determined by an individual authorized under Health Occupations Article, Annotated Code of Maryland, to make medical determinations, is medically unstable; or (d) Does not meet the eligibility criteria under §A(1)(a) of this regulation. (3) An RCS program may not exclude an individual solely because the individual: (a) Does not participate in other treatment or rehabilitation programs; or (b) Is homeless. B. Screening Assessment. (1) If an individual who is authorized for services has not, before the individual's entry into the RCS program, been evaluated face-to-face by a physician who documents the elements included in this section, an appropriately privileged mental health professional, in collaboration with the individual, shall conduct a screening assessment to: (a) Assess the individual's needs and willingness to participate in RCS; (b) Document: (i) The diagnosis, if any, provided by the referral source; and (ii) If applicable, medications that are prescribed for the individual; (c) In consultation with the individual and, if any, the referral source, outline a preliminary plan for the RCS services to be provided if the individual enters RCS services, including, at a minimum, the level and type of staff support required for the individual's first 48 hours in the program, and, when appropriate, enhanced support such as: (i) 24-hour, on-site; (ii) 24-hour, on-site, awake; or (iii) One-to-one; and (d) Inform the individual of the rules of the program and the process and procedure for discharge, including situations as outlined under Regulation .12E of this chapter. (2) If, following the assessment under §B(1) of this regulation, the RCS program director determines that the program's services are not appropriate for an individual who has been referred, the program director shall promptly: (a) Inform the individual and, if the individual is a child, the parent or guardian, of the determination and the reason; (b) With proper consent, notify the family or significant others designated by the individual of the determination and of any recommendations for other services; and (c) Notify the CSA and the Administration's ASO for appropriate alternative referral. C. Admission. Unless an individual has been re-referred to the Administration's ASO under the provisions of §B(2)(c) of this regulation, an RCS program shall initiate services to an individual if: (1) The individual accepts the rules of the RCS program; and (2) When the individual referred for RCS is a child, the parent or guardian signs an agreement with the provider to accept the child for placement upon discharge from RCS. #### Regulation .06 Evaluative Services. *COMAR 10.21.26.06* A. Initial Evaluation. Before the development of the individual treatment plan (ITP), an individual entitled under Health Occupations Article, Annotated Code of Maryland, to render a psychiatric diagnosis shall conduct a face-to-face evaluation with the individual, and, if the individual is a child, with the child's primary caretaker, to: (1) Describe the presenting problem and history of present illness; (2) Collect and evaluate relevant medical and mental health history, including, if any: (a) Previous inpatient and outpatient treatment; and (b) A review of current medications and source of prescriptions; (3) Evaluate current mental status; (4) Either: (a) Formulate and document a psychiatric diagnosis and the rationale for the diagnosis; or (b) Affirm the psychiatric diagnosis, not more than 1 year old, formulated by the referral source and documented in the individual's medical record; and (5) Identify needed treatment. B. Assessment. Before the development of the ITP, the individual's assigned treatment coordinator shall conduct a face-to-face evaluation with the individual, and, if the individual is a child, with the child's primary caretaker, to: (1) Identify the individual's strengths, needs, and desires; (2) Assess the individual's level of functioning and availability of family and other social supports; (3) Complete an assessment that includes, at a minimum, a review of: (a) The individual's: (i) Legal status; (ii) Housing status; (iii) Current employment and economic status; (iv) History of substance abuse; (v) History of physical or sexual abuse; (vi) History of violence or assaultive behaviors; (vii) Natural support system; (viii) Activities of daily living; and (ix) Interpersonal skills; and (b) For a child, in addition to the requirements of §B(3)(a) of this regulation, the child's: (i) Developmental status; (ii) Educational history and current placement; (iii) Involvement with other agencies; (iv) Home environment; and (v) Family history and evaluation of the current family status, including legal custody status; and (4) Initiate the process to determine who will provide the individual's mental health care and treatment upon discharge from crisis services. C. Diagnosis. The program director shall assure that, before the development of the ITP, RCS staff documents the psychiatric diagnosis rendered according to §A(4) of this regulation. D. Somatic Care. (1) The program director shall assure that RCS staff coordinates an individual's care with, when known and with proper consent, the individual's somatic care provider. (2) Within 48 hours before or not more than 72 hours after an individual's admission into the program, an individual authorized under Health Occupations Article, Annotated Code of Maryland, shall: (a) Assess the individual's general physical health; (b) Determine whether the individual requires a physical examination or somatic care follow-up; and (c) Make appropriate referrals for services. #### Regulation .07 Treatment Planning and Evaluation. *COMAR 10.21.26.07* A. Individual Treatment Plan (ITP). (1) Treatment Team. At a minimum the following shall participate as members of an individual's RCS program treatment team: (a) The designated treatment coordinator; (b) Relevant RCS staff providing services to the individual; and (c) When available, relevant staff from other agencies currently providing services to the individual. (2) Individual Treatment Plan. Within 24 hours of placement in an RCS program, based on the screening evaluation under Regulation .05C of this chapter, the initial evaluation under Regulation .06A of this chapter, the assessment under Regulation .06B of this chapter, and the psychiatric diagnosis under Regulation .06C of this chapter, the treatment team shall prepare an ITP: (a) In collaboration with: (i) The individual; (ii) For a child, the parent or guardian and, if other than the parent or guardian, the primary caretaker; and (iii) When appropriate and with proper consent, the individual's family and others involved in the individual's care; (b) That includes, at a minimum: (i) The psychiatric diagnosis as provided in Regulation .06C of this chapter; (ii) A description of the individual's current behavior, symptoms, and level of functioning that includes the individual's presenting strengths, needs, and treatment expectations and responsibilities; (iii) When relevant to the individual, a description of the family's or significant others' needs and strengths; (iv) Mental health treatment goals, including the plan for transition and discharge, to be accomplished during an individual's residence in an RCS program, which are outcome oriented and stated in behavioral, measurable terms; and (v) The anticipated length of stay in the RCS program; and (c) That specifies treatment strategies, including: (i) Recommended modality and frequency of interventions, including, if appropriate, case management services; (ii) Target dates for goal achievement; (iii) The designation of RCS staff responsible for implementing the elements of the plan; (iv) Scheduled daytime activities, if any, such as a partial hospitalization program (PHP), psychiatric rehabilitation program (PRP) on-site or off-site services, and school services; and (v) When appropriate, identification of, recommendations for referral to, and collaboration with, other services to support the individual's treatment. (3) Signature of the ITP. (a) The individual or, for a child, the parent or guardian shall sign or tape record agreement or disagreement with the ITP and reviews. (b) A child's primary caretaker, if other than the parent or guardian, shall sign or tape record acknowledgment of the ITP and reviews. (c) In addition, the following shall sign the ITP and reviews: (i) The individual's treatment coordinator; (ii) When there is an RCS psychiatrist, the RCS psychiatrist; and (iii) When there is a mental health professional, the mental health professional. (4) Discharge Before the ITP. When an individual is discharged within 24 hours of admission to RCS, if the treatment team has not developed an ITP, the treatment coordinator shall document, in the individual's medical record, a brief description of the goals established and interventions employed. B. Continued Evaluation. (1) Contact Notes. In order to assure that services to an individual are timely and appropriate, staff shall document in the individual's medical record contact notes regarding all clinically relevant face-to-face, telephone, and written contacts with or about the individual, including the dates, locations, and types of contacts. (2) Progress Summary Notes. The individual's treatment coordinator shall document or assure that staff document in the individual's medical record a daily progress summary note that includes: (a) A description of progress toward goals; (b) Changes in goals and interventions based on the review of progress; and (c) The rationale for the changes. #### Regulation .08 Required Staff. *COMAR 10.21.26.08* A. The program director shall ensure that the RCS staff is sufficient in numbers and qualifications to carry out the program's service goals and includes, at a minimum, the staff identified in this regulation and Regulations .09 — .11 of this chapter. B. Program Director. The governing body shall employ a program director who: (1) As determined by the governing body, has sufficient qualifications, knowledge, and experience to execute the duties of the position; (2) Is available to provide RCS administration and supervision: (a) For the amount of time necessary to carry out the duties and, at a minimum, 10 hours per week; and (b) If a RCS program operates in more than one site, by: (i) Designating, as necessary, staff to manage services at each site and report to the program director and (ii) Having contact with each site each week; (3) Is responsible for operational oversight for, at a minimum: (a) Fulfilling the administrative requirements under COMAR 10.21.17 and the day-to-day operations of the RCS program; (b) Maintaining sufficient staff, including recruiting, hiring, scheduling, and terminating; (c) Consulting on the development and implementation of the budget; (d) Keeping the governing body informed of, at a minimum, the program's approval status and performance; and (e) In collaboration with appropriate RCS staff, assuring staff compliance with: (i) Credentialing and privileging; (ii) Appropriate training and supervision; and (iii) When required, the on-call availability of a psychiatrist; and (4) If appropriately credentialed and privileged, may provide RCS services. C. Treatment Coordinator. The program director shall assign to each individual who is receiving RCS a treatment coordinator who, as privileged by the program, shall provide or coordinate the services outlined in this chapter for the specific type and level of RCS. D. Direct Service Providers. The program director shall employ a sufficient number of direct service providers who: (1) As determined by the program, have sufficient qualifications and experience to carry out the duties of the position; (2) Before providing services, have training applicable to the service, including, at a minimum, training in: (a) Crisis intervention; (b) Suicide prevention; (c) Behavior modification; and (d) Family interactions; and (3) As permitted under the Health Occupations Article, Annotated Code of Maryland, and as privileged by the program, provide the level and intensity of supervision and support required under this chapter for the specific type and level of RCS indicated in an individual's ITP. #### Regulation .09 Staff Support and Mental Health Services — Inpatient Admission Prevention. *COMAR 10.21.26.09* A. Staff Support. The program director shall assure that the program: (1) Has at least one staff person on duty at all times that a resident is present in the RCS facility; (2) Has the capacity for and, when required by an individual's ITP, provides 24-hour awake staff support; (3) Has the capacity for 1:4 coverage and, when required by an individual's ITP, provides 1:4 coverage; and (4) If the program serves children, provides at least one staff member for every three children. B. Psychiatric Evaluation and Intervention. The program director shall assure that a psychiatrist provides evaluation and prescribed needed treatment interventions, either: (1) By consultation with the psychiatrist who is currently treating the individual; or (2) Through a written agreement with a provider of mental health treatment, who will provide face-to-face evaluation by a psychiatrist before the development of the ITP. C. Treatment and Support Services. (1) The program director shall assign to each individual who is receiving RCS a treatment coordinator who shall assure that the individual receives: (a) The care or treatment recommended under Regulation .07A of this chapter; (b) Monitoring of the individual's condition; (c) Supportive counseling focused on: (i) Assessment and definition of problems; (ii) Planning and goal setting; (iii) Development of effective problem-solving techniques; and (iv) Evaluation of progress; (d) Assistance in accessing community resources, including case management, that are essential to meeting the individual's identified needs; and (e) Transition services and discharge planning. (2) Medication Services. (a) Monitoring. A member of the treatment team privileged to do so shall provide the following medication monitoring services: (i) Supporting the individual's self-administration of medications, including both prescribed and over-the-counter medications; (ii) To the extent possible, monitoring compliance with instructions appearing on the label or a more recent physician's order; (iii) Reading the label to assure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date; (iv) Assuring that each individual has secure, appropriate, and accessible space in which to store medications; (v) Observing and documenting medications taken and any apparent reactions to the medication, and, either verbally or in writing and in a timely fashion, communicating to the prescribing authority problems that possibly may be related to the medication; and (vi) Reinforcing education on the role and effects of medication in symptom management. (b) Administration. If an individual's ITP requires that RCS staff administer medication, only an individual authorized to do so under Health Occupations Article, Annotated Code of Maryland, may administer medication. #### Regulation .10 Staff Support and Mental Health Services — Inpatient Admission Alternative. *COMAR 10.21.26.10* A. Staff Support. The program director shall ensure: (1) That sufficient staff are on duty at all times to relate to the expected clinical needs of the individuals in the residence; and (2) At a minimum: (a) The provision of at least one on-site, awake staff for every four individuals receiving RCS or, if a child is in the residence, one staff for every three individuals; (b) The availability, based upon clinical acuity and the request of on-duty staff, of at least one other staff member to arrive at the RCS program within 1 hour of a request; and (c) That the program has the capacity for 1:1 coverage, and provides 1:1 coverage when clinically indicated. B. Psychiatric Evaluation and Intervention. The program director shall assure that a psychiatrist: (1) Is available on call, 24 hours per day, 7 days per week; (2) Within 24 hours of an individual's admission: (a) Conducts a face-to-face evaluation; (b) Either: (i) Formulates and documents a psychiatric diagnosis and the rationale for the diagnosis; or (ii) Affirms the psychiatric diagnosis formulated under Regulation .06A(4) of this chapter; and (c) Through participation in the ITP, prescribes treatment interventions; and (3) If the individual presents a danger to self, indicates appropriate staff coverage and precautions. C. Treatment and Support Services. (1) The program director shall ensure that a mental health professional: (a) Provides regular supervision of all treatment staff; and (b) Each day, either: (i) Monitors, face-to-face, an individual's condition and documents significant changes; or (ii) Consults with staff regarding the clinical needs of an individual. (2) The program director shall assign a treatment coordinator who shall assure that the individual receives: (a) Care or treatment recommended under Regulation .07A of this chapter; and (b) The services under Regulation .09C(1)(c) — (e) of this chapter. (3) Medication Services. (a) Monitoring. When required by the individual's ITP, a member of the treatment team credentialed and privileged to do so shall provide medication monitoring, as outlined in Regulation .09C(2)(a) of this chapter. (b) Administration. The program director shall assure that an individual authorized under Health Occupations Article, Annotated Code of Maryland, is available to administer medication in a case where medication administration is required by an individual's ITP. #### Regulation .11 Staff Support and Mental Health Services — Treatment Foster Care. *COMAR 10.21.26.11* A. Staff Support. The RCS program director shall assure that: (1) RCS mental health professional staff provides, to the foster care provider, specialized training in mental health crisis recognition, management, and intervention, before placing any individuals in the foster home; and (2) The RCS program has the capacity to provide staff to deliver, in the foster home, on an emergency basis: (a) 24-hour, awake supervision; and (b) One-to-one support. B. Psychiatric Evaluation and Intervention. The program director shall ensure appropriate evaluation and documentation of needed treatment interventions: (1) By consultation with the psychiatrist who is currently treating the individual; (2) Through a written agreement with a provider of mental health treatment, who will provide face-to-face evaluation by a psychiatrist before the development of the ITP; or (3) Through a written agreement with an outpatient mental health clinic, approved under COMAR 10.21.20, that will provide consultation with a psychiatrist and face-to-face evaluation by a mental health professional privileged by the program and appointed by the medical director to provide the service. C. Treatment and Support Services. (1) The program director shall assure that: (a) An individual receives the care or treatment outlined in the ITP under Regulation .07A of this chapter; and (b) As required by an individual's ITP, a mental health professional is available to provide mental health services on site at the foster home. (2) Medication Services. (a) A foster care provider shall: (i) Administer an individual's medications, as permitted under COMAR 10.27.11; or (ii) Monitor an individual's self-administration of medications. (b) The program director shall assure that, if an individual's ITP requires that RCS staff provide medication services, monitoring or administration of medication is carried out as outlined under Regulation .09C(2) of this chapter. #### Regulation .12 Transition and Discharge. *COMAR 10.21.26.12* A. Discharge Policy. The program director shall: (1) Collaborate with the Administration's ASO to: (a) Arrange for discharge from the program when services are no longer authorized by the Administration's ASO; and (b) Make recommendations for referral for alternative services for an individual for whom the program's services are not appropriate; and (2) Maintain clearly written policies and procedures for: (a) Transition services; (b) Collaborative discharge from the program; and (c) Making recommendations for discharge and referral for alternative services for an individual for whom the program's services are not appropriate. B. Transition. The treatment coordinator shall: (1) Collaborate with the Administration's ASO to provide interim services and assure appropriate referrals for authorization for case management and other service providers before discharge; and (2) With proper consent and while the individual is still in the RCS program, contact the providers who have been authorized to provide the services designated in the discharge summary. C. Collaborative Discharge. When the Administration's ASO, in consultation with the treatment coordinator, determines that services are no longer medically necessary, the rehabilitation coordinator shall: (1) Prepare a discharge plan based on an assessment of the individual's current service needs and mutually agreed upon goals, in collaboration with: (a) The individual, and, for a child, the primary caretaker; and (b) With proper consent: (i) Family or significant others designated by the individual; and (ii) When feasible, other treatment and service providers; (2) When needed, make appropriate recommendations to the Administration's ASO for treatment, rehabilitation, and community supports; and (3) Complete a discharge summary in accordance with COMAR 10.21.17.07D(3). D. Individual's Discontinuation of Services. When an individual discontinues services before a planned, collaborative discharge as described in §C of this regulation, the treatment coordinator shall: (1) When possible, give the individual information about appropriate alternate services; (2) If authorized by the Administration's ASO, provide appropriate outreach to encourage the individual to access appropriate services; (3) With proper consent, provide notice of the discontinuation to: (a) The emergency contact named by the individual at the time of admission; (b) When feasible, other service providers, including the individual's somatic care provider, when known; and (c) When needed, the CSA and the Administration's ASO, for referral for appropriate alternative services; and (4) Complete a discharge summary in accordance with COMAR 10.21.17.07D(3). E. Program's Recommendation to Discontinue Services. If, in consultation with the program director, the treatment coordinator recommends discharging an individual who does not comply with the program's rules or for whom the program's services are not appropriate, the program director shall: (1) Provide written notice of the intention to discharge from services and recommend referral for alternative services: (a) To the individual and, for a child, the parent or guardian and, if other than the parent or guardian, the primary caretaker; (b) With proper consent to: (i) The emergency contact named by the individual at the time of admission; (ii) When feasible, other service providers; and (iii) When needed, the CSA and the Administration's ASO, for referral for appropriate alternative services; (c) That includes: (i) The effective date of the action; (ii) The reason for the action; and (iii) When possible, a discharge plan; and (2) Complete a discharge summary in accordance with COMAR 10.21.17.07D(3). ### Chapter 27 — Community Mental Health Programs — Respite Care Services **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: November 16, 1998 (25:23 Md. R. 1697) #### Regulation .01 Scope. *COMAR 10.21.27.01* This chapter outlines the staffing and service requirements for a provider of respite care services. #### Regulation .02 Definitions. *COMAR 10.21.27.02* A. In this chapter, terms have the meanings stated in COMAR 10.21.17 and in this regulation. B. Term Defined. “Respite care” means services that are: (1) Provided for an adult with serious and persistent mental illness or a child with serious emotional disturbance; (2) Provided on a short-term basis in a community-based setting; and (3) Designed to support an individual to remain in the individual's home by: (a) Providing the individual with enhanced support or a temporary alternative living situation; or (b) Assisting the individual's home caregiver by temporarily freeing the caregiver from the responsibility of caring for the individual. #### Regulation .03 Approval. *COMAR 10.21.27.03* The Department shall grant approval to a program to be eligible to receive State or federal funds for providing respite care services if the program: A. Is approved as: (1) A mobile treatment services (MTS) provider under COMAR 10.21.19; (2) An outpatient mental health clinic (OMHC) under COMAR 10.21.20; or (3) A psychiatric rehabilitation program (PRP) under COMAR 10.21.21; and B. Meets the requirements of this chapter, including approval to provide either or both of the following specific respite care services: (1) In-home respite, in an individual's place of residence; (2) Out-of-home respite, in a home or facility that is appropriately licensed, registered, or approved, based on: (a) The age of individuals receiving services; and (b) Whether the respite is partial day or overnight. #### Regulation .04 Program Model. *COMAR 10.21.27.04* A. The program director shall assure that respite care services are: (1) Designed to fit the needs of the individuals served and their caregivers; and (2) Delivered by individuals who are privileged by the program to provide a particular service. B. As approved under this chapter, a program may provide respite care services as needed for an individual: (1) With advance planning; or (2) As needed in an immediate situation, to resolve or ameliorate a problem in the living situation. #### Regulation .05 Referral, Eligibility, Screening, and Acceptance for Respite Services. *COMAR 10.21.27.05* A. Referral. An individual or the individual's caregiver may request respite care services, or an agency providing mental health treatment or support services to an individual may refer the individual for respite care services. B. Eligibility. (1) An individual is eligible to receive respite care if: (a) The individual is a participant, as described in COMAR 10.21.25.01D(2), in the public mental health system; (b) The individual has a diagnosis that is listed in COMAR 10.09.70.02; (c) The individual is: (i) An adult who has serious and persistent mental illness and who lives independently or in a family-like setting, or in a residential rehabilitation program (RRP) under the provisions of COMAR 10.21.22; or (ii) A child who has a serious emotional disturbance and who lives with a parent, guardian, or other primary caretaker in a family-like home, or in a foster home under the provisions of COMAR 07.02.11 or 07.02.21; and (d) The services are preauthorized, as needed, by the Administration's administrative services organization (ASO) according to the provisions of COMAR 10.21.17.02-1A. (2) An individual is not eligible to receive respite care if the individual is a resident of a therapeutic group home (TGH) licensed under COMAR 10.21.07 or a facility licensed under Health-General Article, Title 19, Annotated Code of Maryland. C. Screening. Upon receipt of a referral for respite care, the program director shall ensure that respite care staff: (1) Conduct a screening assessment with the: (a) Individual for whom respite care services are requested; (b) The caregiver or significant other, if any; and (c) Referral source, if any; (2) Evaluate whether the respite care is needed: (a) At a specific future time; (b) Immediately; or (c) Intermittently; (3) Outline, in consultation with the individual and the caregiver, a preliminary plan, including the schedule for respite care, for the services to be provided in accordance with this chapter; (4) Based on consultation with the individual and, if any, the referral source, document: (a) The expected duration of the respite care; (b) The frequency, level, and type of staff contacts needed, such as staff availability: (i) At a minimum, on call, 24 hours per day, 7 days per week; or (ii) On site for up to 24 hours per day, 7 days per week; and (c) If applicable, medications that are prescribed for the individual; and (5) Inform the individual and the caregiver of the rules for the respite care episode. D. Acceptance. Upon acceptance of an individual for respite care, staff assigned by the program director, in consultation with the individual and the caregiver, shall: (1) Perform an assessment of: (a) The individual's and the caregiver's strengths and needs; and (b) Interventions needed by the individual during respite; (2) In order to ensure continuity of care, document information regarding, at a minimum, the individual's participation in: (a) Outpatient mental health treatment; (b) Psychiatric rehabilitation; (c) School; (d) Work; or (e) Other scheduled activities; (3) Taking into consideration the needs under §§C(4) and D(2) of this regulation, formulate an initial plan for respite services, including the: (a) Schedule for providing respite care; (b) Location; (c) Level of staff support; (d) Schedule of the individual's activities during respite; and (e) Needed interventions to facilitate the individual's remaining in or returning to the living situation. #### Regulation .06 Respite Services Provided. *COMAR 10.21.27.06* The program director shall ensure that: A. Services are planned according to the duration, frequency, and location of the respite care; B. An individual receives services according to a plan that includes: (1) Based on the initial plan under Regulation .05D(3) of this chapter, a schedule of the individual's activities during respite; (2) When needed, medication monitoring; and (3) The frequency and intensity of staff support; C. Services are coordinated with an individual's individual treatment plan or individual rehabilitation plan; D. Respite staff document a plan to be implemented in the event of a crisis; and E. Staff provide referrals or coordinate referrals with other current treatment providers, as needed, for additional services for the individual. #### Regulation .07 Conclusion of Respite Episode. *COMAR 10.21.27.07* A. Planned Conclusion. At the agreed upon time of conclusion of a respite care episode, the program director shall assure that staff document a summary of the episode in the individual's record. B. Individual's Discontinuation of Services. If an individual elects to discontinue services before the planned conclusion of a respite episode, as described in §A of this regulation, the program director shall: (1) Promptly notify the individual's caregiver or designated emergency contact; (2) If the individual is a child, discharge the child only to an adult who is legally responsible for the child; (3) Notify the CSA and the Administration's ASO of the action; and (4) Assure that staff document a summary of the episode in the individual's record. C. Program's Recommendation to Discontinue Services. If the program director recommends discharging an individual who does not comply with the program's rules or for whom the program's services are not appropriate, the program director shall follow the provisions outlined in §B of this regulation. #### Regulation .08 Respite Staff. *COMAR 10.21.27.08* A. Respite Care Program Director. The MTS, OMHC, or PRP program director shall either: (1) Carry out the respite care program director's duties that are delineated in this chapter; or (2) Appoint a respite care program director with sufficient qualifications, knowledge, and experience to execute the duties of the position. B. Respite Care Specialists. The respite care program director shall employ a sufficient number of staff who: (1) As determined by the program director, have sufficient qualifications and experience to carry out the duties of the position; (2) Before providing services, have training applicable to the service, including, at a minimum, training in: (a) Mental illness and emotional disorders; (b) Psychiatric medications; (c) Crisis intervention; (d) Family interactions; and (e) For staff who provide services to children: (i) Growth and development; and (ii) Behavioral intervention; and (3) As permitted under the Health Occupations Article, Annotated Code of Maryland, and as privileged by the program, are available to carry out the: (a) Program model described in Regulation .04 of this chapter; and (b) Activities outlined in an individual's respite care plan under Regulation .06 of this chapter. ### Chapter 28 — Community Mental Health Programs — Mental Health Vocational Programs (MHVP) **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: July 9, 2001 (28:13 Md. R. 1215) #### Regulation .01 Scope. *COMAR 10.21.28.01* This chapter outlines the staffing and service requirements that a mental health vocational program (MHVP) shall fulfill to be approved by the Department to be eligible to receive State or federal funds to provide services. #### Regulation .02 Definitions. *COMAR 10.21.28.02* A. In this chapter, terms have the meanings stated in COMAR 10.21.17 and in this regulation. B. Terms Defined. (1) Agency-Sponsored Employment. (a) “Agency-sponsored employment” means an employment program designed to assist an individual to obtain employment at locations owned, leased, rented, or managed by the provider, at other locations by an agency-held contract, at a consumer-operated business or program, or work enclave that provides: (i) Compensation to individuals according to the standards established by the Department of Labor; (ii) Opportunity for individuals to have contact with nondisabled individuals and the public to the same extent that nondisabled individuals in comparable positions interact with the public; and (iii) Additional supports, as needed, to the individual in the work setting. (b) “Agency-sponsored employment” does not include sheltered workshops. (2) “Competitive work” means employment in the competitive labor market that pays minimum wage or higher and compensation is consistent with the wage standards provided in the Fair Labor Standards Act. (3) “Consumer-operated business” means a program owned or managed by an individual who has a disclosed mental illness that provides compensated employment for an individual who has a disclosed mental illness. (4) “Employment specialist” means a program staff member who helps individuals in the public mental health system (PMHS) to: (a) Obtain competitive employment; (b) Learn work tasks; (c) Resolve job-related or on-the-job problems; and (d) Maintain competitive employment. (5) “Extended support services” means ongoing support services and other appropriate services needed to support and maintain an individual after the individual has made the transition from time-limited, intensive job-coaching services. (6) “Industry” means the employer hiring an individual in the public mental health system. (7) “Integrated work” means work that provides an individual an opportunity to interact with nondisabled individuals. (8) “Intensive job coaching” means frequent and intensive support provided to an individual at a job site and off a job site during the initial stages of an individual's employment in order for an individual to learn and to manage a job. (9) “Job stability” means a situation in which an individual is performing job duties satisfactorily and is reasonably expected to continue that level of performance. (10) “Natural support” means the assistance received from an individual's family members, significant others, friends, neighbors, and coworkers. (11) “Sheltered workshop” means employment in a workshop or work-activity center or a physically separated department of an agency or organization having an identifiable program of rehabilitation, separate tasks, supervision, records, and compensation for individuals with disabilities. (12) “Supported employment program” means a program designed to assist an individual to obtain competitive employment in an integrated work environment that provides: (a) Compensation to individuals of at least minimum wage; (b) An individualized approach that establishes an hours-per-week employment goal to maximize an individual's vocational potential; (c) Additional supports, as needed, delivered where appropriate; and (d) Transitional employment placements, as appropriate. (13) “Transitional employment” means a series of planned temporary, sequential job placements, with continuous support services, provided to an individual in the public mental health system until job permanency is achieved. (14) “Work enclave” means a group of individuals with mental illness for whom an agency: (a) Has negotiated access to jobs in community businesses; (b) Guarantees completion of the individuals' work; and (c) Provides compensation for the hours worked. #### Regulation .03 Approval. *COMAR 10.21.28.03* The Department may approve a program as an MHVP if the program meets the requirements: A. For approval outlined in COMAR 10.21.16; B. For administration outlined in COMAR 10.21.17; and C. Of this chapter. #### Regulation .04 Authorization for Services. *COMAR 10.21.28.04* Before rendering services to an individual, a provider shall notify the core service agency (CSA) of the jurisdiction in which the individual resides and receive preauthorization for services. #### Regulation .05 Program Model. *COMAR 10.21.28.05* The program director shall ensure that services: A. Are designed to: (1) Support an individual in the public mental health system to be able to: (a) Choose, obtain, and maintain employment; (b) Make vocational decisions and career changes; and (2) Enhance an individual's natural supports; B. Are provided in a flexible manner to support an individual's vocational plan throughout an individual's employment, including periods of unemployment; C. Include: (1) Ongoing assessment and planning with an individual and, when appropriate, an individual's family or natural supports; (2) As needed, vocational training; (3) Marketing to industries in the community; and (4) Referral for services an individual needs, which are not provided by the program; D. Promote placement in a work environment that: (1) Is free of recognized hazards likely to cause serious bodily injury or death and comply with any specific safety and health standards set for the industry; (2) If not free of all recognized hazards likely to cause serious bodily injury or death, provides information to employees regarding the exposure to hazardous materials and substances; and (3) Compensates individuals at least at minimum wage; and E. Are adequate to support an individual's placement in a supported employment program or an agency-sponsored employment program. #### Regulation .06 Eligibility, Screening, and Enrollment. *COMAR 10.21.28.06* A. Eligibility. An individual is eligible for MHVP services if: (1) The individual: (a) Is a participant in the public mental health system; (b) Has a diagnosis listed in COMAR 10.09.70.02; (c) Is an individual for whom competitive employment has not occurred, has been interrupted, or has been intermittent; (d) Wants to work; and (e) Is in need of ongoing MHVP services to enable the individual to choose, obtain, or maintain employment; and (2) The services are preauthorized by the CSA of the jurisdiction in which the individual resides. B. Screening. (1) Upon receipt of a referral and when appropriate, the program shall request authorization from the appropriate CSA to provide services. (2) Within 10 working days of receipt by the program of CSA authorization for MHVP assessment under §A(2) of this regulation, staff assigned by the program director, in collaboration with the individual, shall conduct a screening assessment to: (a) Assess the individual's: (i) Interest in employment and desire to work; (ii) Willingness to participate in MHVP services; and (iii) MHVP services needs; and (b) Determine the program's ability to address the individual's employment needs identified in §B(2)(a)(iii) of this regulation. (3) After the screening under §B(2) of this regulation, if the program director determines that a program's services are not appropriate for an individual, the program director shall, in writing, promptly: (a) Inform the individual of the determination and the reason; (b) Provide the individual with recommendations for alternative services; (c) With proper consent, notify the family or significant others designated by the individual, of the determination and of any recommendations for other services; and (d) Notify the CSA of the determination. (4) Within 10 working days of the screening conducted under §B(2) of this regulation, unless the program director has notified the individual and the CSA of the determination under §B(3) of this regulation, the program director shall notify the individual that the program either: (a) Accepts the individual and identifies a date that the program proposes to initiate services to the individual; or (b) Will accept the individual, following an updated review of the individual's eligibility status, when program capacity permits. (5) If the individual is accepted under §B(4)(b) of this regulation, the program director shall inform the individual of the: (a) Individual's placement on a waiting list, if any; and (b) Estimated date services may be initiated. (6) If the individual is placed on a waiting list under §B(5)(a) of this regulation, the program director shall discuss with the individual: (a) The option of remaining on the program's waiting list until the date established under §B(5)(b) of this regulation; and (b) Alternative services that are available. C. Enrollment. Within 10 working days of the date established under §B(4)(a) of this regulation or following an updated review under §B(4)(b) of this regulation, MHVP staff assigned by the program director shall: (1) Provide an orientation to the program, including: (a) A description of the MHVP services available; and (b) The individual's rights and responsibilities; and (2) In writing, inform the individual of the policy and procedures for discharge, including conditions, as outlined in Regulation .11D of this chapter, that may result in the program's discharging an individual, and making recommendations for alternative services. #### Regulation .07 Assessment and Planning Services. *COMAR 10.21.28.07* A. Vocational Assessment. Within 10 working days of initiation of MHVP services, MHVP staff assigned by the program director to conduct assessments, in collaboration with the individual and, with proper consent, family or significant others designated by the individual, shall complete a face-to-face MHVP assessment that includes, at a minimum: (1) Documentation of the individual's employment interests, preferences, and skills; (2) An evaluation that identifies the individual's competencies, work needs, and readiness for employment; (3) Identification of obstacles and barriers to work such as transportation and impact on entitlements; (4) Relevant information from the screening conducted under Regulation .06B of this chapter; and (5) If appropriate, relevant information from previous vocational screenings or assessments. B. Individual Vocational Plan (IVP). (1) Initial IVP. Within 30 days of initiation of MHVP services and based on the vocational assessment completed according to §A of this regulation, the individual's employment specialist shall prepare an initial IVP: (a) In collaboration with: (i) The individual; (ii) With proper consent, family or significant others designated by the individual and others involved in the individual's care; and (iii) If appropriate and with proper consent, other mental health service providers, as available; (b) That, if applicable and with proper consent, is coordinated with the: (i) Maryland State Department of Education, Division of Rehabilitation Services' (DORS) individual plan for employment; and (ii) Individual's individual treatment plan, individual rehabilitation plan, and case management personal plan; (c) That is designed to assist the individual to identify, obtain, and maintain vocational goals; (d) That identifies the individual's: (i) Strengths; (ii) Vocational service needs; (iii) Vocational goals, including target dates; (iv) Vocational interventions, including but not limited to a systematic plan of instruction in work skills and behaviors to be learned and, if applicable, benefits management and staff responsible for implementation; and (v) Plan for obtaining a job that matches the individual's interests, preferences, abilities, and needed accommodations and adaptations. (2) IVP Review. As frequently as necessary, as determined by an individual's employment specialist, and at least every 6 months, the employment specialist, in consultation with the individual, shall: (a) Review and record in the individual's employment record: (i) The individual's progress toward the accomplishment of previously identified vocational goals; (ii) Goal changes, based on a review of the individual's progress; and (iii) Changes in interventions, including staff responsibility; (b) Communicate promptly the results of the review to: (i) Relevant program staff; and (ii) With the individual's consent, community mental health programs providing services to the individual and family or significant others; (c) Assess the individual's satisfaction with the job and the MHVP services; and (d) When the individual is employed through agency-sponsored employment, assess the individual's preferences and readiness for competitive work. (3) Signature of the IVP and IVP Reviews. The employment specialist shall obtain the individual's written or witnessed verbal agreement or disagreement with the plan, and, in addition, the following shall sign the plan and reviews: (a) The employment specialist; and (b) Other MHVP staff responsible for implementing the plan. C. Continuing Evaluation. At least once a month the employment specialist shall record in the individual's MHVP employment record a progress summary note regarding: (1) The delivery of services, including those outlined in Regulation .07B(1)(d) of this chapter, specified by the IVP; (2) Progress toward goal achievement; (3) Changes in the individual's status; (4) If applicable, coordination with DORS; and (5) If applicable, suggested changes in employment goals and vocational services delivered. #### Regulation .08 MHVP Services. *COMAR 10.21.28.08* A. Entitlement and Resource Education Services. The program director shall ensure that MHVP staff educate an individual about: (1) The financial impact of employment on disability benefits, entitlements, and other benefits; (2) Access to such Social Security programs as Plan to Achieve Self- Sufficiency and Impairment-Related Work Expense and the individual's rights and responsibilities under such programs; (3) Access to additional benefits and other resources; and (4) Benefits and risks of disclosure to the employer of the individual's disability. B. Job Development and Placement Services. The program director shall ensure that MHVP staff: (1) Develop close cooperation with industries, unions, and other community resources related to employment opportunities; (2) Regularly survey the local business community and develop an ongoing marketing strategy to increase employment opportunities for individuals served; (3) When appropriate, facilitate an appropriate match between an individual and a job by reviewing the: (a) Benefits and wages; (b) Necessary work skills; (c) Required functional abilities; (d) If applicable, accommodations and adaptations required for the individual; (e) Opportunities to participate in work-related social activities to develop natural support; and (f) Employee orientation; (4) When appropriate, ensure that the individual receives, at a minimum, information regarding the: (a) Job duties; (b) Salary scale and benefits; (c) Work schedule; (d) Responsibilities of the employer; (e) Responsibilities of the individual; (f) Fringe benefits; (g) Wage payment practices; (h) Nondiscrimination provisions; and (i) Process for the filing and resolution of grievances; and (5) When an individual's employment status changes, assists the individual to maintain the goal of employment by facilitating additional job placements. C. Employment Support Services. The program director shall ensure that, as required by an individual's IVP, the individual's employment specialist: (1) Provides or arranges for the provision of: (a) Job coaching, which includes training in job tasks and responsibilities; (b) Assistance, upon request, and with the individual's consent, to the industry on effective strategies to help the individual remain on the job; and (c) Activities directed toward the development of skills, including, but not limited to: (i) Personal hygiene and grooming specific to the employment environment; (ii) Effective communication with supervisor and coworkers; and (iii) Transportation to and from work; and (d) Extended support services, which may include §C(1)(a) — (c) of this regulation, in order to assist the individual to maintain employment; (2) Encourages the individual to: (a) Use natural supports; and (b) Develop an employment-related support system through relationships with coworkers, supervisors, and others in the work environment; (3) Provides the services outlined in this regulation, when appropriate, and with the individual's consent, at the job site or at another location appropriate to the individual's needs; and (4) Has at least two face-to-face contacts a month with the individual. #### Regulation .09 Additional Requirements — Supported Employment Model. *COMAR 10.21.28.09* In addition to the requirements under Regulations .01B(1) and .05E(1) of this chapter, an MHVP supporting individuals in a SEP program shall provide: A. With proper consent, at least one contact per month with the industry to receive information regarding the individual's performance on the job; and B. The services outlined in this chapter. #### Regulation .10 Additional Requirements — Agency-Sponsored Employment Model. *COMAR 10.21.28.10* In addition to the requirements under Regulations .01B(2) and .05E(2) of this chapter, an MHVP supporting individuals in an agency-sponsored program shall: A. Provide additional supports to the individual at the work site, which shall include: (1) Staff, on site, during the hours the individual is employed, to provide: (a) Supervision; (b) Skills assessment; (c) On-the-job training; and (d) Mentoring; and (2) Documentation of an assessment of the individual's potential for community employment at least semiannually; B. In accordance with personnel policy and procedure, provide the individual with the following, if provided to nondisabled employees: (1) Employee benefits; (2) For each pay period, a written statement that indicates gross pay, hours worked, deductions, and net pay; (3) Consistent with federal wage and hour laws at least annually, a review of the individual's wages and work performance; and (4) Wages based on individual performance rather than on group wage payments; C. If paying subminimum wages, be in compliance with DOL regulations, documented by the appropriate DOL certificate; and D. Provide the services outlined in this chapter. #### Regulation .11 Discharge from Services. *COMAR 10.21.28.11* A. Discharge Policy. The program director shall: (1) Maintain clearly written policies and procedures for: (a) The process for discharge; (b) If the program's services are not appropriate for the individual, making recommendations for discontinuing services and referring the individual for alternative services, including the criteria for discontinuing services according to this paragraph; and (c) Providing the individual with information about how to reaccess services when needed; and (2) Notify the authorizing CSA of the determination under §A(1)(b) of this regulation. B. Collaborative Discharge. When the employment specialist, in collaboration with the individual, determines that MHVP services are no longer appropriate, the employment specialist shall: (1) Prepare a discharge plan: (a) In collaboration with: (i) The individual; and (ii) With proper consent, family or significant others designated by the individual and, if feasible, other treatment and service providers; and (b) That is based on an assessment of the individual's current vocational status, service needs, and mutually agreed-upon goals; (2) As necessary, make appropriate recommendations for treatment, rehabilitation, and community supports; (3) Complete a discharge summary in accordance with COMAR 10.21.17.07D(3); and (4) Notify the CSA of the discharge. C. Individual's Discontinuation of Services. When an individual discontinues services before a planned, collaborative discharge as described in §B of this regulation, the employment specialist shall: (1) If possible, give the individual information about appropriate alternative services; (2) If authorized, provide outreach to encourage the individual to access appropriate services; (3) With proper consent and if needed, provide notice of the discontinuation to the CSA or the Department's administrative services organization for referral for appropriate alternative services; and (4) Complete a discharge summary in accordance with COMAR 10.21.17.07D(3). D. Program's Recommendation to Discontinue Services. (1) If, in consultation with the program director, the employment specialist recommends discontinuing services for an individual for whom, because of the individual's actions, the program's services are not appropriate, the program director shall provide written notice of the intention to discontinue services and recommend referral for alternative services. (2) Except in the case of imminent danger, the program director shall provide the notice at least 30 days before discontinuing services. (3) The program director shall ensure that the notice is sent to the individual and, with proper consent, to the CSA or the Department's administrative services organization for referral for appropriate alternative services. (4) The program director shall include in the notice: (a) The effective date of the action; (b) The reason for the action; and (c) If possible, a discharge plan. (5) The program director shall ensure that staff complete a discharge summary in accordance with COMAR 10.21.17.07D(3). #### Regulation .12 Program Staff. *COMAR 10.21.28.12* A. A provider of MHVP shall ensure that MHVP staff includes, at a minimum: (1) A program director who: (a) Has sufficient qualifications, knowledge, and experience to execute the duties of the position; (b) Is available for an amount of time calculated on the basis of a half-hour per individual receiving services, up to a maximum of 40 hours per week; (c) Is available to provide MHVP administration and supervision; and (d) May provide MHVP services; (2) Employment specialists who have sufficient qualifications, knowledge, and experience to work with the individuals served by the program; and (3) Program staff sufficient to carry out the: (a) Program model described in Regulation .04 of this chapter; (b) Services delineated under Regulation .10 of this chapter; and (c) Activities outlined in the individual's IVP. B. The program director shall assure that the MHVP: (1) Has a clear description of the role and function of the staff providing MHVP services; (2) Staff is sufficient in numbers and qualifications to carry out the program's service goals and includes, at a minimum, the staff identified in this regulation; and (3) Has a contingency plan for staff availability to provide necessary MHVP services to an individual in the absence of regularly assigned staff. C. Ratio. A provider of MHVP services shall maintain a maximum ratio of one MHVP employment specialist serving each 15 individuals receiving MHVP services. D. Volunteers, Students, and Trainees. The program may use volunteers, students, and trainees according to the provisions of COMAR 10.21.17.09E. ### Chapter 29 — Community Mental Health Programs — Psychiatric Rehabilitation Services for Minors **Authority:** Health-General Article, §§10-901 and 10-902, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 2006 (33:7 Md. R. 669) **Administrative History:** Regulation .05A amended effective February 12, 2007 (34:3 Md. R. 299) **Administrative History:** Regulation .07A amended effective February 12, 2007 (34:3 Md. R. 299) #### Regulation .01 Scope. *COMAR 10.21.29.01* This chapter outlines the service requirements and staffing standards for a psychiatric rehabilitation program (PRP) for minors that provides psychiatric rehabilitative services to a minor. #### Regulation .02 Definitions. *COMAR 10.21.29.02* In this chapter, terms have the meanings stated in COMAR 10.21.17. #### Regulation .03 Approval. *COMAR 10.21.29.03* The Department shall grant approval to a program to be eligible to receive State or federal funds for providing PRP services for minors if the program meets the requirements: A. For approval outlined in COMAR 10.21.16; B. For administration outlined in COMAR 10.21.17; C. For Medical Assistance providers outlined in COMAR 10.09.36, 10.09.59, and 10.09.70; and D. Of this chapter. #### Regulation .04 Program Model. *COMAR 10.21.29.04* A. A provider of PRP services for minors shall: (1) Have a facility that: (a) Meets all relevant federal, State, or local ordinances, laws, regulations, and orders governing the program; (b) Is not located in a private residence; (c) Is accessible to the public; and (d) Contains a secure area where records, logs, and business information may be kept; (2) Prominently display the hours of operation of the facility; (3) Provide services at the PRP facility and at other locations according to the needs of the individuals served; (4) Assure that individuals receiving services have the choice to receive services on-site or at another suitable location; and (5) Assure that program staff are available by telephone, on call, 24 hours per day, 7 days per week. B. The program director shall organize program services and supports to: (1) Facilitate the development of a minor's independent living and social skills, including the minor's ability to make decisions about the minor's life and create opportunities for choice, to the degree that is age and developmentally appropriate, regarding: (a) Home; (b) School or work; and (c) Community; and (2) Promote the use of community resources to integrate the minor into the community. C. The program director shall ensure that: (1) Services are: (a) Appropriate to the age of the populations being served; (b) Offered at times suitable to the minors served; (c) Coordinated with other mental health services that the minor is receiving; (d) Goal directed; (e) Outcome focused; (f) Available as long as the minor meets medical necessity criteria for PRP services; (g) Based on a functional assessment of the minor across life domains; (h) Part of a total plan of care, which is directed at maintaining the minor in their home and preventing out-of-home placement; (i) Integrated with the minor's ITP; and (j) Designed to reduce functional behavioral impairments and restore and strengthen age-appropriate skills; (2) If the PRP provides services to minors in a specific age group or with a particular clinical profile, the initiation of service criteria is consistent with the populations to be served; (3) When the PRP provides services in a facility, the services shall be provided on a regular basis and include a variety of group and individual rehabilitation activities that incorporate individual rehabilitation goals; and (4) If the PRP provides services to both minors and adults, the program activities for minors are separate from program activities for adults, unless the adult receiving PRP services is a parent or caregiver of the minor. #### Regulation .04-1 Notification and Consent Requirements. *COMAR 10.21.29.04-1* A. A parent or guardian of a minor shall receive all notifications and information regarding PRP services for a minor, unless the minor is 16 years old or older and has consented to PRP services rather than a parent. B. If a minor who is 16 years old or older and has consented to PRP services rather than a parent or guardian, consent from the minor shall be obtained before providing a parent or guardian any notifications or information regarding PRP services for a minor. #### Regulation .05 Eligibility, Screening, and Initiation of Service. *COMAR 10.21.29.05* A. Eligibility. (1) A minor is eligible for PRP services if, as a result of a serious emotional disturbance, the: (a) Minor: (i) Has been referred for PRP services by a licensed mental health professional who is providing inpatient, residential treatment center, or outpatient mental health services to the minor; (ii) Is currently in, and remains in active mental health treatment; and (iii) Has the appropriate consent to participate in PRP services; and (b) Administration's administrative services organization: (i) Determines that the services are medically necessary; and (ii) Authorizes the services according to the provisions of COMAR 10.21.17.03A. (2) PRP services for minors shall be prioritized for minors who have a serious emotional disturbance and who meet the following eligibility criteria: (a) Have severe functional impairments in at least one or more life domains; (b) Based on the clinical evaluation and ongoing treatment plan, are, with PRP services, expected to have reduced symptoms of their mental illness or their functional behavioral impairment as a result of their mental illness; (c) Have an impairment as a result of their mental illness that results in: (i) A clear, current threat to the minor's ability to be maintained in the minor's customary setting; (ii) An emerging or pending risk to the safety of the minor or others; or (iii) Other evidences of significant psychological or social impairment such as inappropriate social behavior causing serious problems with peer or family relationships; (d) Due to dysfunction, is at risk for requiring a higher level of care, or is returning from a higher level of care; (e) There is clinical evidence that: (i) The current intensity of outpatient treatment will not be sufficient to reduce the minor's symptoms and functional behavioral impairment resulting from the mental illness and restore the minor to an appropriate functional level, or prevent clinical deterioration, or avert the need to initiate a more intensive level of care due to the current risk to the individual or others; or (ii) For minors transitioning from an inpatient, day hospital, or residential treatment setting to a community setting, PRP services will be necessary to prevent clinical deterioration and support successful transition back to the community, or avert the need to initiate or continue a more intensive level of care; (f) The minor's disorder can be expected to improve through medically necessary rehabilitation or there is clinical evidence that this intensity of psychiatric rehabilitation is needed to maintain the minor's level of functioning; and (g) The minor is judged to be in enough behavioral control to be safe in the psychiatric rehabilitation program and benefit from the psychiatric rehabilitation provided. (3) In addition to those minors outlined in §A(1) and (2) of this regulation, a PRP for minors may provide services to other minors who either contract privately for services or for whom another agency contracts for services. (4) If a PRP for minors provides services to a minor outlined in §A(3) of this regulation, the PRP may not seek reimbursement by the PMHS for providing services to that minor. B. Screening. (1) Within 5 working days of receipt by the program of a complete referral for PRP services, staff assigned by the program director, in collaboration with the minor and the minor's parent or guardian, if appropriate, shall schedule an appointment to conduct a face-to-face screening assessment to: (a) Assess the minor's: (i) Rehabilitation services needs; (ii) Willingness to participate in PRP services; and (b) Determine the program's ability to address the needs identified in §B(1)(a) of this regulation. (2) If, following the screening assessment under §B(1) of this regulation, the program director determines that the program's services are not appropriate for a minor who has been referred, the program director shall, in writing, promptly: (a) Inform the minor and the parent or guardian, if appropriate, of the determination and the reason; and (b) Provide the minor, and the parent or guardian, if appropriate, with recommendations for alternative services. (3) Within 5 working days of the screening assessment conducted under §B(1) of this regulation, unless the program director has notified the minor of the determination under §B(2) of this regulation, the program director shall notify the minor and the parent or guardian, if appropriate, whether the program: (a) Accepts the minor and identifies a date that the program can initiate services to the minor; (b) Will accept the minor, following an updated review of the minor's eligibility status, when program capacity permits, and inform the minor of the: (i) Minor's placement on a waiting list, if any; and (ii) Estimated date services may be initiated; or (c) Will accept the minor following the minor's discharge or release from an inpatient facility, RTC, or detention center. (4) If the minor is placed on a waiting list under §B(3)(b) of this regulation, the program director shall discuss with the minor and, if appropriate, the minor's parent or guardian: (a) The option of remaining on the program's waiting list until the date established under §B(3)(b) of this regulation; and (b) Alternative services that are available. C. Initiation of Services. Before the initiation of services, PRP staff assigned by the program director shall: (1) Document: (a) That a parent or guardian has applied for entitlements for which the minor may be eligible; (b) If the application has been made, the outcome of the minor's application; and (c) If the application has not been made, that staff have assisted the minor's parent or guardian to apply for entitlements; and (2) Discuss with the minor and, if appropriate, the minor's parent or guardian, and provide written documentation to the minor and, if appropriate, the minor's parent or guardian, of the charges for services and, if applicable, the process for determining ability to pay. #### Regulation .06 Evaluation and Planning Services. *COMAR 10.21.29.06* A. Review of Somatic Status. (1) According to provisions outlined in this section and upon a minor's enrollment into the program, a staff member assigned by the program director shall document in the minor's medical record: (a) Pertinent past and current medical history including: (i) The minor's somatic health problems, if any, including but not limited to allergies, neurologic disorders, and communicable diseases; (ii) Relevant medical treatment, including medications; and (iii) Needed somatic care follow-up, if any; and (b) If the minor does not have a primary care provider, and, if indicated, the plan, including the time frame, for the minor's referral to a primary care provider for evaluation and treatment. (2) If indicated, the minor's rehabilitation coordinator shall document and communicate with the minor's primary care provider. (3) If indicated, the minor's rehabilitation coordinator shall discuss with the minor, and the parent or guardian, if appropriate, the need for medical care and facilitate access to said care. B. Rehabilitation Assessment. (1) Within 14 calendar days of initiation of PRP services, PRP staff assigned by the program director to conduct assessments, in collaboration with the minor and, with proper consent, the parent or guardian, shall complete a face-to-face rehabilitation assessment. (2) The assigned staff shall document in the rehabilitation assessment, at a minimum: (a) The minor's age and developmentally appropriate strengths, skills, and needs in the following areas: (i) Self-care skills; (ii) Social, peer, family, and teacher interaction skills; (iii) Participation in psychiatric treatment; (iv) Semi-independent living skills; (v) Family support and resources; (vi) Academic achievement; (vii) Community and informal support systems; and (viii) Adaptive equipment or resources; (b) As relevant, a review of the minor's legal status and forensic history, if any; and (c) The minor's history of physical abuse, sexual abuse, or substance abuse, if any. C. Individual Rehabilitation Plan. (1) Initial IRP. Within 30 calendar days of initiation of PRP services and based on the rehabilitation assessment described in §B of this regulation, the minor's rehabilitation coordinator shall prepare an initial IRP: (a) In collaboration with: (i) The minor; (ii) The parent or guardian, if appropriate; and (iii) If appropriate and with proper consent, other mental health service providers, as available; (b) That includes, at a minimum: (i) The minor's presenting needs, strengths, and rehabilitation expectations and responsibilities; (ii) A description of needed and desired program services and interventions and staff responsible for implementation; (iii) A description of how the needed and desired skills and supports will help the minor to be successfully maintained in the home or community, and manage the minor's psychiatric disorder; (iv) Rehabilitation goals in measurable terms, and target dates for each goal; and (v) If appropriate, identification of, recommendations for, and collaboration with, other services to support the minor's rehabilitation, including but not limited to mental health treatment, residential services, and somatic care; and (c) That is reflective of the minor's overall plan of care. (2) Individual Treatment and Rehabilitation Plan (ITRP). In collaboration with the mental health treatment coordinator, the rehabilitation coordinator may combine the required elements of an ITP and IRP in one document, the ITRP. (3) Rehabilitation Plan Review. As frequently as necessary, as determined by a minor's rehabilitation coordinator, and, at a minimum of every 3 months, the rehabilitation coordinator, in consultation with the minor, shall: (a) Review and record in the minor's medical record: (i) The minor's progress toward the accomplishment of previously identified rehabilitation goals; (ii) Goal changes, based on a review of the minor's progress; (iii) Changes in interventions, as appropriate; and (iv) Progress toward the reduction of functional behavioral impairments and restoration of specific age-appropriate skills; (b) Communicate promptly the results of the review to: (i) Relevant program staff; (ii) The minor's parent or guardian, if appropriate; (iii) With proper consent, community mental health programs providing services to the minor; and (iv) With proper consent, the referring licensed mental health provider; and (c) If the minor's service needs change, provide and document in the minor's record: (i) The suggested changes in rehabilitation goals and services; and (ii) Staffing and support services required by the change. (4) Signature of the IRP Plan and Reviews. (a) The following shall sign agreement with the IRP and ITRP reviews: (i) The minor; (ii) The minor's rehabilitation coordinator; and (iii) The minor's parent or guardian, if appropriate. (b) If the minor is unwilling to sign an agreement with the IRP and ITRP reviews, the minor's rehabilitation coordinator shall: (i) Verify the minor's verbal agreement with the IRP and ITRP reviews; (ii) Document the rationale for the minor's refusal to sign; and (iii) Obtain the agreement and signature of agreement of the minor's parent or guardian. (c) In addition, for an ITRP, at least two mental health professionals, who collaborate about the minor's treatment, shall sign the IRP and ITRP reviews, including: (i) The minor's rehabilitation coordinator, and if the rehabilitation coordinator is not a mental health professional, the mental health professional who supervises the rehabilitation coordinator; and (ii) The minor's treating mental health professional; (d) If the minor is receiving medication prescribed through an outpatient mental health clinic (OMHC), the minor's rehabilitation coordinator shall provide the OMHC psychiatrist with a copy of the minor's IRP and ITRP reviews. D. Continuing Evaluation. (1) Contact Notes. Staff shall document: (a) Each contact with or about the individual, including, at a minimum: (i) The date; (ii) The start and end time of services, if not documented in a readily accessible billing document; (iii) The minor's chief medical complaint or reason for the visit; (iv) The delivery of services specified by the IRP or ITRP; (v) A brief description of the service provided; and (vi) A legible signature, which may include an electronic signature, and printed or typed name of the program staff member providing care, with the appropriate title. (2) Progress Summary Notes. At a minimum, each month, the rehabilitation coordinator shall record in the minor's medical record a progress summary note that includes: (a) The staff member's assessment of the minor's progress toward goal achievement in measurable terms; (b) The minor's assessment of progress toward goal achievement; and (c) Justification for the need for ongoing PRP services. (3) If at least one contact note described in §D(1) of this regulation includes the information outlined in §D(2) of this regulation, the monthly progress summary note is not required. (4) The rehabilitation coordinator shall document that the minor's needs and progress are promptly communicated to: (a) Staff involved in the implementation of the IRP or ITRP; and (b) The minor's parent or guardian, if appropriate; and (c) With proper consent, other community mental health programs providing services to the minor. #### Regulation .07 Rehabilitation and Support Services Provided. *COMAR 10.21.29.07* A. PRP services may only be provided to a minor if identified in the minor's IRP and referred for PRP services by: (1) A licensed mental health professional who is providing inpatient, residential treatment center, or outpatient mental health services to the minor; and (2) Staff who have been privileged by the program to provide the services. B. Rehabilitation Activities. The program director shall ensure that the program provides rehabilitation activities directed toward the development or restoration of skills including: (1) Age-appropriate self care skills, including: (a) Personal hygiene; (b) Grooming; (c) Nutrition; (d) Dietary planning; (e) Food preparation; and (f) Self-administration of medication; (2) Social skills, including community integration activities, developing natural supports, and developing linkages with and supporting the minor's participation in community activities; (3) Independent living skills, including: (a) Maintenance of the minor's living environment; (b) Community awareness; (c) Mobility skills; (d) Money management; and (e) Accessing available entitlements; (4) Activities that support the minor's cultural interests; (5) Conflict resolution; (6) Anger management; (7) Interactive skills with peers and authority figures; (8) Maintaining personal living space; (9) Maintaining age-appropriate boundaries; (10) Maintaining personal safety in a social environment; and (11) Time management, including constructive use of structured and unstructured time. C. Medication Services. (1) Administration. (a) An individual licensed to administer medication under Health Occupations Article, Annotated Code of Maryland, may do so. (b) A licensed practical nurse or a registered nurse may delegate the administration of medication only according to the provisions of COMAR 10.27.11. (2) Monitoring. A PRP staff member shall provide the following services: (a) Support the individual's self-administration, as appropriate, of prescribed medication; (b) Read the medication label to ensure that each container of medication is clearly labeled with the individual's name, the contents, directions for use, and expiration date; (c) To the extent possible, monitor compliance with instructions appearing on the medication label; (d) Ensure that each individual has secure, appropriate, and accessible space in which to store medications; (e) Observe and document any apparent reactions to medication and, either verbally or in writing and in a timely fashion, communicate to the prescribing authority any problems that possibly may be related to the medication; and (f) Reinforce, with the individual, education on the role and effects of medication in symptom management. D. Promotion of Illness Self Management. (1) As is age appropriate, staff shall provide education and information regarding mental illness. (2) The program director shall ensure that the minor's rehabilitation coordinator collaborates with the minor to identify effective strategies to assist the minor to manage the minor's illness. (3) The strategies identified under §D(2) shall include, at a minimum, the minor's identification of: (a) Potential problematic symptoms; (b) Warning signs of relapse; (c) Helpful interventions; and (d) Other individuals the minor identifies to resolve the situation in order for the minor to remain in service or to seek treatment. (4) The minor's illness self management strategies shall be documented and may be incorporated in the minor's IRP, ITP, mental health advance directive, or any combination of them. (5) The strategies shall be reviewed at the time of the IRP review and may be revised or revoked at any time at the request of the minor. E. On-Call and Emergency Response. The program director shall assure that: (1) On-call and emergency response services are available by a licensed mental health professional to an individual who has been admitted to the PRP: (a) Face-to-face during the hours that the PRP is open; and (b) By telephone, on an on-call basis, 24 hours per day, 7 days per week, during the hours the PRP is not open: (i) Through the PRP; or (ii) Through an agreement with another mental health crisis service provider; (2) PRP staff provide to a minor: (a) Intensive support and assistance, as authorized, including but not limited to: (i) Providing one-to-one staff support for the minor, if necessary; (ii) Escorting the minor while accessing needed assistance or services; and (iii) Obtaining input from the mental health professional who is providing outpatient mental health services to the minor; (b) Information regarding needed services; and (c) If necessary, referral for appropriate health care. F. If emergency care is necessary, all relevant staff shall: (1) Have access to the names, addresses, and telephone numbers of providers, including the hospital, that are designated to provide emergency care and treatment to the minors served; and (2) Be appropriately trained to link minors to emergency care, as needed. G. Linkage with a Minor in a Psychiatric Inpatient Facility, Residential Treatment Center (RTC), or Detention Center. (1) If a minor who is enrolled in a program is admitted to a psychiatric inpatient facility, RTC, or detention center, the rehabilitation coordinator shall make reasonable efforts to maintain ongoing communication with the minor and the minor's inpatient treatment team. (2) To the degree permitted by the setting, PRP staff serving the minor shall participate in aftercare or release planning from that setting. #### Regulation .08 Discharge from Services. *COMAR 10.21.29.08* The program director shall maintain clearly written policies and procedures, which may be contained in one document, for the process for discharge from the program as outlined in COMAR 10.21.17.11. #### Regulation .09 Program Staff. *COMAR 10.21.29.09* A. Following an analysis of the complexity and number of minors served, the program director, with input from program staff, shall ensure the development of a staffing plan that identifies the type and number of staff needed to implement the program's rehabilitation service goals. B. A provider shall ensure that the staff includes the following, who are employed by the PRP for the amounts of time outlined in §§C — E of this regulation: (1) A program director, who: (a) Is qualified according to §F(1) of this regulation and who is responsible for the duties under §F(2) of this regulation; and (b) May be responsible for the duties of the rehabilitation specialist under §G(1)(b) of this regulation, if the program director: (i) Is qualified according to §G(1)(a) of this regulation; and (ii) Devotes the time required, under §C, D, or E of this regulation, to the development and implementation of rehabilitation services that reflect the need of the minors served by the program; (2) As required under §C, D, or E of this regulation, a rehabilitation specialist or specialists, qualified according to §G(1)(a) of this regulation, to carry out the duties under §G(1)(b) of this regulation; and (3) As required under §D or E of this regulation, staff designated to carry out administrative duties assigned by the program director. C. If a PRP has fewer than 30 enrollees, the PRP shall employ either: (1) A program director and a rehabilitation specialist, each of whom is employed by the program for a minimum of 20 hours per week; or (2) A program director who is responsible for the duties of the program director and the duties of a rehabilitation specialist, if the program director: (a) Has the qualifications described under §G(1)(a) of this regulation; (b) Is employed by the program for 40 hours per week; and (c) Devotes at least 20 hours per week to the development and implementation of rehabilitation services that reflect the needs of the minors served by the program. D. If a PRP has 30 — 100 enrollees, the PRP shall employ either: (1) A program director, who is employed by the program for a minimum of 20 hours per week, and a rehabilitation specialist, who is employed by the program for a minimum of 40 hours per week; or (2) A program director who is responsible for the duties of the program director and the duties of a rehabilitation specialist, if the program director: (a) Has the qualifications described under §G(1)(a) of this regulation; (b) Is employed by the program for 40 hours per week; and (c) Designates staff who devote 20 hours per week to carrying out specific assigned administrative duties. E. If a PRP has more than 100 enrollees, the PRP program shall employ: (1) A program director who is employed by the program for 40 hours per week; and (2) A rehabilitation specialist or specialists and staff assigned to administrative duties, as follows: (a) A rehabilitation specialist who is employed by the program for 40 hours per week; (b) Two rehabilitation specialists, each of whom is employed by the program for 20 hours per week; or (c) If the program director has the qualifications described under §G(1)(a) of this regulation: (i) A rehabilitation specialist who is employed by the program for 20 hours per week; and (ii) Designated staff who devote 20 hours per week to carrying out specific assigned administrative duties. F. Program Director. The program director: (1) Shall have: (a) Sufficient qualifications, knowledge, and experience to execute the duties of the position; and (b) A minimum of 3 years experience working with emotionally disturbed youth; and (2) Is responsible for administrative oversight of the PRP, including, at a minimum: (a) Fulfilling the administrative requirements under COMAR 10.21.17; (b) Fulfilling the programmatic requirements of this chapter; (c) Keeping the advisory committee, or governing body, whichever is applicable, informed of, at a minimum, the program's approval status and performance; and (d) Quality management. G. Psychiatric Rehabilitation Staff. The program director shall employ psychiatric rehabilitation staff, including: (1) At least one rehabilitation specialist who: (a) Is a licensed mental health professional with a minimum of 2 years direct care experience working with emotionally disturbed youth; (b) Shall advise the program director regarding development and implementation of rehabilitation services that reflect the need of the minors served by the program; (c) Has overall responsibility for rehabilitation services, including: (i) Developing and assuring that rehabilitation services meet the needs of the individuals served by the program; and (ii) Providing oversight for the daily program of rehabilitation services; and (d) Shall educate direct care staff on how to document the correlation between rehabilitation activities and the goals identified in the IRP or ITRP; (2) Direct service staff who: (a) Are supervised by a licensed mental health professional or a rehabilitation specialist; (b) Have 60 hours of on-the-job direct PRP supervision before providing services to minors served by the program without direct supervision; (c) At a minimum, have: (i) A bachelor's degree in a health-related field; (ii) An associate's degree in a health-related field; (iii) 30 hours, or their equivalent, of college credit toward a bachelor's degree in a health-related field; or (iv) 1 year of work experience in a supervised mental health setting; and (d) Are responsible for implementing the rehabilitation activities outlined in the minor's IRP. H. Ratio. (1) The program shall maintain an average ratio of at least one rehabilitation staff member serving each six minors who are either attending the PRP facility or receiving off-site services. (2) To achieve this ratio, the program: (a) May not include: (i) The program director; or (ii) Volunteers; and (b) May include students only if, in calculating the ratio, three rehabilitation staff are on duty for each student. I. Students. The program may use students according to the provisions of COMAR 10.21.17.11E. J. Volunteers. The program may use volunteers according to the provisions of COMAR 10.21.17.11F. ### Chapter 30 — Telemental Health Services **Authority:** Health-General Article, §10-901, Annotated Code of Maryland **Administrative History:** Effective date: September 6, 2010 (37:18 Md. R. 1214) #### Regulation .01 Scope. *COMAR 10.21.30.01* A. This chapter applies to public mental health system (PMHS) outpatient mental health centers (OMHC) or individual psychiatrists to provide psychiatric consultation, evaluation, and ongoing treatment, via interactive video telemental health (TMH) technologies to eligible individuals: (1) Located in designated rural geographic areas of Maryland; or (2) For whom personal psychiatric services are not available. B. The purpose of providing psychiatric care via TMH technology is to: (1) Improve access to outpatient psychiatric care, thus reducing the individual's admission to emergency rooms, inpatient facilities, or detention centers; (2) Improve access to outpatient and inpatient psychiatric subspeciality consultation, thus improving diagnostic clarification, treatment recommendations, and planning for the individual; and (3) Improve capacity and choice for outpatient ongoing psychiatric treatment, thus reducing the need to travel outside the community when local resources are limited. #### Regulation .02 Definitions. *COMAR 10.21.30.02* A. In this chapter, terms have the meanings stated in COMAR 10.21.17 and this regulation. B. Terms Defined. (1) “Critical access hospital” means a hospital that is certified to receive cost-based reimbursement from Medicare. (2) “Designated rural geographic areas” means the rural geographical areas in Maryland identified by the Department that typically have mental health needs that have limited local mental health resource capacity or specialty psychiatric care. (3) “Distant site” means the site at which the psychiatrist is located at the time the mental health service is provided via a telecommunications system. (4) “Emergency department services” means initial hospital services provided to individuals with a broad spectrum of illnesses and injuries, some of which may be life-threatening and requiring immediate attention. (5) “Federally qualified health center” has the meaning stated in Health-General Article, §24-1301, Annotated Code of Maryland. (6) “Individual practitioner” means a psychiatrist who is licensed to practice psychiatry in Maryland, and either: (a) Is certified in psychiatry by the American Board of Psychiatry and Neurology; or (b) Has completed the minimum educational and training requirements to be qualified to take the Board of Psychiatry and Neurology examination for certification in Neurology. (7) “Not available” means that the PMHS administrative services organization certifies that the individual cannot access psychiatric services. (8) “Originating site” means a site that has been approved by the Department to provide TMH services, at which an eligible individual is located at the time the service is delivered via a telecommunications system. (9) “Originating site fee” means the amount the Department reimburses an approved TMH originating site. (10) “Professional fee” means the amount the Department reimburses an approved TMH distant facility or licensed individual mental health professional: (a) For a clinical care opinion, treatment, or both; (b) To purchase, install, and maintain video conferencing equipment; (c) To pay for line or per minute usage charges, or both; and (d) For any additional programmatic, administrative, clinical, or contingency support at the distant site. (11) Public Mental Health System (PMHS). (a) “Public mental health system” means the system for the delivery of mental health treatment and supports to individuals who meet medical necessity criteria and financial eligibility as established by the Administration. (b) “Public mental health system” includes the specialty mental health system described in COMAR 10.09.70. (12) “Rural health clinic” means a facility that meets the definition of a rural health clinic as contained in 42 CFR §491.2(f), as amended. (13) “Security” means the protection of information and information systems from unauthorized access, use, disclosure, disruption, modification, or destruction. (14) “Telemental Health (TMH)” means the delivery of mental health care at a distance through the use of technology-assisted communication. (15) “Telepresenter” means the individual at the originating site who introduces the patient to the distant site provider for examination, and to whom the distant site provider may delegate tasks and activities, and who is: (a) A licensed independent practitioner; or (b) Licensed or certified to perform health care services by licensing, training, or experience for the performance of the task or activity as long as the task or activity does not require the exercise of independent medical judgment for its performance. (16) “Telepresenter fee” means the amount the Department reimburses a licensed, independent provider to present an individual to the TMH provider, due to medical necessity, to successfully complete the examination. (17) “Virtual private network connection” means a method of connecting to a private network via a public network. #### Regulation .03 Approval. *COMAR 10.21.30.03* The Department shall grant approval to a TMH provider to be eligible to receive State or federal funds for providing interactive TMH services if the TMH provider meets the requirements of this chapter and: A. For outpatient mental health centers, COMAR 10.21.20; or B. If the TMH provider is an individual psychiatrist, COMAR 10.09.36. #### Regulation .04 Service Model. *COMAR 10.21.30.04* A. TMH provides the opportunity for community-based medical and mental health providers to access general or subspecialty psychiatric care providers from other areas of the State. B. TMH providers may be private practice, part of a hospital, academic, health, or mental health care system. C. PMHS approved community-based providers or individual practitioners may engage in agreements with TMH providers for services. D. Fee-for-service reimbursement shall be at an enhanced rate, as stipulated by the Department, provided all applicable provisions of this chapter are met and funds are available. #### Regulation .05 Eligibility. *COMAR 10.21.30.05* A. Individual Eligibility. An individual is eligible to receive TMH services if the individual: (1) Is Medicaid eligible; (2) Meets the eligibility and medical necessity criteria for participation in the Public Mental Health System; (3) Resides in one of the designated rural geographic areas or whose situation makes person-to-person psychiatric services unavailable; and (4) Voluntarily consents to TMH services, which shall be documented in the individual's medical record. B. Individual Provider Eligibility. A provider of TMH services shall be a psychiatrist who: (1) Has an active: (a) License to practice psychiatry in Maryland; and (b) Medicaid provider number; (2) Complies with professional practice standards; and (3) Completes a registration to provide TMH health services. C. Originating Site Facility Eligibility. The following Maryland sites may be approved as an originating site for THM health service delivery: (1) County government offices appropriate for private clinical evaluation services; (2) Critical Access Hospital; (3) Federally Qualified Health Center; (4) Hospital; (5) Outpatient mental health center; (6) Physician's office; (7) Rural Health Clinic; (8) Elementary, middle, high, or technical school with a supported nursing, counseling or medical office; or (9) College or university student health or counseling office. D. Distant Site Location Eligibility. An approved distant TMH location shall be within the State. #### Regulation .06 Technical Requirements. *COMAR 10.21.30.06* A provider of TMH health services shall have video technology components as follows: A. A minimum bandwidth of 384 KBPS (H.263), 256 KBPS (H.264), or technical equivalent; B. A monitor with a: (1) Minimum net display of 16" diagonally; and (2) Non-anamorphic video picture display; C. A minimum video resolution of 1 Common Intermediate Format (CIF), or 1 Source Input Format (SIF); D. Internet protocol sessions that are encrypted unless they are conducted entirely on a protected network, or using a virtual private network connection; and E. A camera at the originating site, that has pan, tilt, and zoom capabilities that can be remotely controlled from the distant site. #### Regulation .07 Confidentiality. *COMAR 10.21.30.07* All originating and distant TMH sites shall comply with the rules and regulations concerning the privacy and security of protected health information under: A. Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and B. The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320D et seq., as amended, and the implementing regulations at 45 CFR Parts 160 and 164, as amended. #### Regulation .08 Medical Records. *COMAR 10.21.30.08* A. Originating Site. The originating site shall: (1) Be responsible for maintaining a complete medical record as if the individual were seen face-to-face at the originating site; (2) Meet the facility and community standard for medical record completion and retention, including applicable record reviews; and (3) Be responsible for any proper release of information contained in an individual's medical record. B. Distant Site. (1) The distant site shall maintain copies of all documentation completed by the distant site TMH provider unless the distant site TMH provider enters the information directly into the originating site's electronic medical record system. (2) The distant site, as part of its quality improvement system, shall have a process to review TMH care. (3) As part of quality monitoring, when the originating site's electronic medical records are reviewed at the distant site, the: (a) Review may include the TMH provider's documentation online, if authorized; or (b) Distant site may request sections of the individual's electronic medical record from the originating site for the distant site peer review. C. TMH records shall be retained according to the provisions of Health-General Article, §4-403, Annotated Code of Maryland. #### Regulation .09 Covered Services. *COMAR 10.21.30.09* A. TMH services shall be authorized by the Administration's administrative service organization. B. The Department shall reimburse an approved TMH provider for rendering the following psychiatric services to an eligible child, adolescent, or adult via a telecommunications system: (1) Diagnostic interview; (2) Individual therapy, with or without medication evaluation and management; (3) Family therapy, with or without the identified patient; (4) Group therapy for each individual, up to a maximum of 8 individuals; (5) Outpatient evaluation and management for a new or established patient; (6) Outpatient office consultation for a new or established patient; (7) Initial inpatient consultation for a new or established patient; and (8) Emergency department services. #### Regulation .10 Reimbursement. *COMAR 10.21.30.10* A. There are three categories of fees that the Department shall reimburse an approved TMH provider, as applicable: (1) Originating site fee; (2) Professional fee; and (3) Telepresenter fee. B. Originating Site Fee. (1) The originating site facility fee is set forth by the Center for Medicare and Medicaid Services, published annually and included in the Medicare Physician Fee Schedule Final Rule, issued by November 1, prior to the start of the calendar year for which it is effective. (2) Originating sites only may file for reimbursement and shall use the appropriate code modifier. (3) Fees paid to the originating site may be used to: (a) Purchase, install, and maintain video conferencing equipment; (b) Pay for line or per minute usage charges, or both; and (c) Any additional programmatic, administrative, clinical or contingency support at the originating site. C. Professional Fee. Professional Fee for individual providers or OMHC providing TMH is set forth in COMAR 10.21.25. D. Telepresenter Fee. Telepresenter Fees for assisting in TMH are set forth in 10.21.25 and subject to the following requirements prior to billing: (1) A telepresenter fee is applicable only when, due to medical necessity, a licensed independent practitioner is required to present the individual to the distant provider to successfully complete the examination; (2) Fees for telepresenters that are not licensed independent practitioners, and fees for telepresenters that are licensed independent practitioners, but their presence is not medically necessary, are included as part of the originating site facility fee; and (3) The distant provider shall clearly document in the individual's medical record the rationale requiring the involvement of the licensed independent practitioner, as medically necessary, at any particular session. ### Chapter 31 — Maryland Mental Health AND Substance Use Disorder Registry and Referral System **Authority:** Health-General Article, §7.5-802, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.05 adopted as an emergency provision effective January 27, 2023 (50:4 Md. R. 119); expired effective July 26, 2023 **Administrative History:** Regulations .01—.06 adopted effective June 24, 2024 (51:12 Md. R. 619) #### Regulation .01 Purpose and Effective Date. *COMAR 10.21.31.01* Effective January 27, 2023, there is a Maryland Mental Health and Substance Use Disorder Registry and Referral System to provide a statewide system through which health care providers can identify and access available inpatient and outpatient mental health and substance use services for patients in a seamless manner. #### Regulation .02 Scope. *COMAR 10.21.31.02* This chapter applies to: A. Hospitals under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; B. Freestanding medical facilities under Health-General Article, Title 19, Subtitle 3(a), Annotated Code of Maryland; and C. Any other provider type designated by the Department by issuance of a transmittal sent to all designated providers. #### Regulation .03 Definitions. *COMAR 10.21.31.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Department” means the Maryland Department of Health. (2) “Facility” means a hospital, freestanding medical facility, or provider designated by the Department. (3) “Hospital” means a general or special hospital licensed under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and COMAR 10.07.01. (4) “Maryland Mental Health and Substance Use Disorder Registry and Referral System” or “Bed Registry and Referral System” means the system operated by the Department through which health care providers can identify and access available inpatient and outpatient mental health and substance use services for patients. #### Regulation .04 Use. *COMAR 10.21.31.04* A facility shall: A. Refer an individual who may require additional care coordination for inpatient, outpatient, or community-based behavioral health services, after undergoing an initial psychiatric evaluation, no later than 48 hours after arrival at the facility at a phone number or website address designated by the Department through written directives to implement the Bed Registry and Referral System; and B. Provide all necessary patient information, including, but not limited to, diagnosis and level of care recommendations to the respective care coordination centers. #### Regulation .05 Daily Reporting. *COMAR 10.21.31.05* A facility shall report current bed availability and census information, and any additional relevant information requested by the Department, to populate the inpatient psychiatric bed board as necessary to keep the information updated, but not less than three times per day, during the following periods: A. 9 a.m. to 12 p.m.; B. 1 p.m. to 3 p.m.; and C. 4 p.m. to 7 p.m. #### Regulation .06 Penalties. *COMAR 10.21.31.06* A. A hospital that violates this chapter is subject to the fines, penalties, and actions specified in Health-General Article, Title 19, Annotated Code of Maryland. B. A provider who violates this chapter is subject to the fines, penalties, and actions specified in Health-General Article, Title 7.5, Annotated Code of Maryland, and COMAR 10.63. ## Subtitle 22 — Developmental Disabilities ### Chapter 01 — Definitions **Authority:** Health-General Article, §§2-104(b) and 7-904, Annotated Code of Maryland **Administrative History:** Effective date: July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .01B amended effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .01B amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency action extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .01B amended effective November 25, 2013 (40:23 Md. R. 1934); March 13, 2017 (44:5 Md. R. 293) #### Regulation .01 Definitions. *COMAR 10.22.01.01* A. In this subtitle, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Developmental Disabilities Administration of the Maryland Department. (2) “Alternative living unit (ALU)” means a residence owned, leased, or operated by a licensee that: (a) Provides residential services for individuals who, because of a developmental disability, require specialized living arrangements; (b) Admits not more than 3 individuals; and (c) Provides 10 or more hours of supervision per unit, per week. (3) “Assistive technology” means the technology necessary to enable the individual to live successfully in the community. (4) “Aversive technique” means the use of painful or noxious stimuli to the body, which is intrusive to the individual's physical, mental, or emotional well-being, used to terminate challenging or maladaptive behavior. (5) “Barrier” means an obstacle preventing or inhibiting an individual from receiving services and supports in the most integrated setting appropriate to meet the individual's needs. (6) “Behavior plan (BP)” means a plan designed to modify behavior through the use of clinically accepted techniques. (7) Behavioral Consultation. (a) “Behavioral consultation” means on-site observation, assessment, and evaluation of the interaction between the individual and the individual's caregiver in the context of the individual's existing programs. (b) “Behavioral consultation” includes: (i) Recommendations regarding the structure of the program and appropriate activities and services; and (ii) Consultation, as needed, with clinical professionals. (8) “Behavioral emergency” means a situation in which an individual's behavior appears to present imminent danger to the individual or to others. (9) “Behavioral respite” means relief services provided by a community residential licensee to meet an individual's behavioral needs. (10) “Care provider” means an individual who is responsible for the daily operation of an individual family care home as defined in §B(26) of this regulation. (11) “Challenging behavior” means those behaviors exhibited by an individual which: (a) Are harmful, destructive, or socially unacceptable; and (b) Necessitate being addressed in the individual's individual plan. (12) “Chemical restraint” means the use of an injectable medication as an intervention in a behavioral emergency. (13) “Community supported living arrangement home” means a residence: (a) Which is rented or owned by an individual or the individual's family or proponent or held in trust for an individual; (b) Where an individual lives as a roommate without the individual's name appearing on the lease or title; or (c) Where the licensee is the guarantor of rental or mortgage payments for an individual receiving CSLA services. (14) Community Supported Living Arrangements. (a) “Community supported living arrangements (CSLA)” means services to assist an individual in nonvocational activities necessary to enable that individual to live in the individual's own home, apartment, family home, or rental unit, with: (i) No more than two other nonrelated recipients of these services; or (ii) Members of the same family regardless of their number. (b) “Community supported living arrangements (CSLA)” includes personal support services, as defined under the Administration’s Home and Community-Based Services Waiver with the Centers for Medicare and Medicaid Services, including but not limited to the following services: (i) Personal assistance services; (ii) Supports that enhance the individual’s opportunity for community participation and to exercise choice and control over the individual’s own life; (iii) Training, habilitation, and other services necessary to assist the individual in achieving and maintaining increased integration, interdependence, and productivity; and (iv) 24-hour emergency assistance. (c) “Community supported living arrangements (CSLA)” also includes other services set forth in the Administration’s Home and Community-Based Services Waiver with the Centers for Medicare and Medicaid Services as distinct from personal support services, including but not limited to the following: (i) Assistive technology; (ii) Adaptive equipment; (iii) Resource coordination; (iv) Environmental modifications; (v) Respite; and (vi) Other services as approved by the Secretary or the Secretary’s designee. (15) “Department” means the Maryland Department of Health. (16) “Developmental disability” means a severe chronic disability of an individual that: (a) Is attributable to a physical or mental impairment, other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; (b) Is likely to continue indefinitely; (c) Is manifested in an individual younger than 22 years old; (d) Results in an inability to live independently without external support or continuing and regular assistance; and (e) Reflects the need for a combination and sequence of special, interdisciplinary, or generic care, treatment, or other services that are individually planned and coordinated for the individual. (17) “Director” means Director of the Developmental Disabilities Administration or the Director's designee. (18) “Eligible for individual support services” means an individual with a severe chronic disability that is: (a) Attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; and (b) Likely to continue indefinitely. (19) “Environmental modification” means physical adaptations to an individual's home that are provided to enable the individual to live safely at home. (20) “Foreign corporation” means an entity that is properly organized, chartered, and incorporated under the laws of a state other than Maryland. (20-1) “Forensic residential center (FRC)” means a facility that is: (a) Licensed to provide a continuum of integrative services to individuals with intellectual disabilities: (i) Ordered by the court for an evaluation or to be confined; (ii) Court-committed for care or treatment to the Department as incompetent to stand trial or not criminally responsible who are dangerous as a result of intellectual disabilities; or (iii) On conditional release and returned to the facility either voluntarily or on hospital warrant; (b) A related institution as defined in Health-General Article, §19-301(o), Annotated Code of Maryland; and (c) Not an extended care or comprehensive rehabilitation facility. (21) “Functional analysis” means a method of investigation which involves the systematic, experimental manipulation of analogue conditions, and precise measurement of challenging behavior, in order to determine the behavioral consequences which maintain the challenging behavior. (22) “Functional assessment” means a nonexperimental method, such as systematic observations and questionnaires, designed to assist in the formulation of an educated guess concerning the behavioral consequences which maintain challenging behavior. (23) “Generic services” means services which are available to the community at large. (24) “Goal” means measurable supports or training to achieve an outcome. (25) “Group home” means a residence owned, leased, or operated by a licensee that: (a) Provides residential services for individuals who, because of a developmental disability, require specialized living arrangements; (b) Admits at least four, but not more than eight individuals; and (c) Provides 10 or more hours of supervision per week. (26) “Individual” means a person eligible to receive services from the Developmental Disabilities Administration. (27) “Individual family care (IFC) home” means a private, single family residence which provides a home for up to three individuals with developmental disabilities, who are unrelated to the care provider. (28) “Individual plan (IP)” means a plan that specifies assessments, services, supports, and training required by the individual. (29) “Integrated work setting” means an environment in which individuals with developmental disabilities and individuals without developmental disabilities work together. (30) “Licensed capacity” means the number of individuals for whom a licensee is authorized to provide services at a single site. (31) “Licensed certified social worker” means a person authorized to practice social work under Health Occupations Article, Title 19, Annotated Code of Maryland. (32) “Licensed health care practitioner” means a person licensed to provide health care within the scope of Health Occupations Article, Annotated Code of Maryland. (33) “Licensed or certified professional counselor” means a person who is authorized to practice professional counseling under Health Occupations Article, Title 17, Annotated Code of Maryland. (34) “Licensed physician” means a person who is authorized to practice medicine under Health Occupations Article, Title 14, Annotated Code of Maryland. (35) “Licensed psychologist” means a person who is authorized to practice psychology under Health Occupations Article, Title 18, Annotated Code of Maryland. (36) “Licensee” means an agency that has been granted a license by the Administration to provide services to individuals. (37) “Management of disruptive behavior” means the Administration-approved curriculum for managing challenging or aggressive behavior. (38) “Mechanical restraint” means a mechanical device which restricts the free movement of an individual, such as a safety coat or posey mittens. (39) “Mechanical support” means a mechanical device used to: (a) Support an individual's proper body position, balance, or alignment, such as splints, wedges, bolsters, or lap trays; or (b) Protect an individual with a continuing medical condition from sustaining an injury, for example, the use of protective head gear for an individual with epilepsy. (40) “Most integrated setting” means a setting that enables an individual with a disability to interact with nondisabled individuals other than staff to the fullest extent possible. (41) “Natural supports” means family, friends, co-workers, and community members who provide informal assistance to the individual to enable the individual to live and work in the community. (42) “Outcome” means tangible results of goals that reflect the desired quality of life as defined by the individual. (43) “Personal assistance” means help with activities of daily living which does not have an habilitation objective. (44) “Physical restraint” means a manual method used to restrict the free movement of an individual, such as therapeutic hold. (45) “Plan of correction (POC)” means the licensee's proposed response to findings of noncompliance identified by the Licensing and Certification Administration or the Administration. (46) “PRN orders” means a preauthorized order to administer a specific behavior management technique or medication to modify behavior which is administered on an as-needed basis when a challenging behavior is exhibited. (47) “Program service plan (PSP)” means the document submitted as part of the licensure application that delineates the rationale, scope, staffing, training, setting, and location for the services or supports to be provided. (48) “Proponent” means a person who has a legitimate interest in the welfare of an individual receiving services from a licensee. (49) “Psychology associate” means a person who may perform psychological services under certain conditions as specified in Health Occupations Article, Title 18, Annotated Code of Maryland. (50) “Record” means the cumulative body of information the licensee has on file regarding an individual. (51) “Resource coordinator” means a professional: (a) Designated by the Developmental Disabilities Administration; (b) Not employed by a direct service provider; (c) Who has knowledge and experience in community supports for individuals with developmental disabilities; and (d) Who meets the requirements of COMAR 10.22.09. (52) “Respite” means relief services provided to the family or care provider to meet planned or emergency situations. (53) “Restrictive technique” means a technique that is implemented to impede an individual's physical mobility or limit free access to the environment, including but not limited to physical, mechanical, or chemical restraints or medications used to modify behavior. (54) “Seclusion” means the involuntary placement of an individual alone in a room. (55) “State residential center (SRC)” means a State owned and operated facility for individuals with intellectual disabilities. (56) “Supports” means the assistance provided to individuals or their families to enable greater participation in the community and enhanced quality of life. (57) “Target behaviors” means those behaviors identified by the team to be changed by implementing a behavior plan. (58) “Team” means those persons, including the individual, proponent, licensee representatives, resource coordinator, and others involved in the development of the IP. (59) “Temporary augmentation of staff” means supplemental staff utilized on a time-limited basis to work with an individual exhibiting challenging behavior. (60) “Treating professional” means an individual designated by the facility director who is involved in the implementation of the IP. (61) “Verbal abuse” means disrespectful shouting, screaming, swearing, name calling, or other verbal activity directed toward an individual. (62) “Vocational assessment” means a method of determining an individual's job and career preferences and the skills and training necessary to accomplish these preferences. (63) “Volunteer work” means work performed by an individual without pay. (64) “Written plan of habilitation” means, for State residential centers, a component of the IP as described in COMAR 10.22.05.02B(14) and .03C. ### Chapter 02 — Administrative Requirements for Licensees **Authority:** Health-General Article, §§7-904 and 7-909, Annotated Code of Maryland **Administrative History:** Effective date: July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .01 amended and recodified to be Regulation .01-1 and new Regulation .01 adopted effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .01 amended effective July 22, 2013 (40:14 Md. R. 1175) **Administrative History:** Regulation .02A, D amended effective January 2, 2006 (32:26 Md. R. 1997) **Administrative History:** Regulation .02A amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .02B amended effective March 13, 2017 (44:5 Md. R. 292) **Administrative History:** Regulation .03 amended effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .04 amended effective January 2, 2006 (32:26 Md. R. 1997) **Administrative History:** Regulation .05B amended effective January 2, 2006 (32:26 Md. R. 1997) **Administrative History:** Regulation .08B, C amended effective January 2, 2006 (32:26 Md. R. 1997) **Administrative History:** Regulation .08B, C amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .10 amended effective December 17, 2007 (34:25 Md. R. 2210) **Administrative History:** Regulation .13D amended effective March 3, 2014 (41:4 Md. R. 300) **Administrative History:** Regulation .13E adopted effective March 3, 2014 (41:4 Md. R. 300) #### Regulation .01 Incorporation by Reference. *COMAR 10.22.02.01* The Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations, (Effective Date: January 15, 2013), is incorporated by reference. #### Regulation .01-1 License Required. *COMAR 10.22.02.01-1* A. In addition to any other license required by law, a person shall be licensed by the Administration before the person may provide any of the following services to an individual with a developmental disability or to an individual eligible to receive individual support services: (1) Vocational and day services; (2) Community residential services; (3) Resource coordination; (4) More than one family support service, as defined in Health-General Article, §7-701, Annotated Code of Maryland; (5) More than one individual support service, as defined in Health-General Article, §7-706, Annotated Code of Maryland; and (6) More than one community supported living arrangement service as defined in Health-General Article, §7-709, Annotated Code of Maryland. B. Waiver. The Director may waive the requirement for a license if a person is licensed or certified by another State agency or accredited by a national accreditation agency, such as the Council on Quality and Leadership in Supports for People with Developmental Disabilities or the Council for Accreditation for Rehabilitation Facilities (CARF), to provide services to an individual with a developmental disability or to an individual eligible for individual support services. C. After notice and an opportunity for a hearing, the Director may revoke the waiver granted under §B of this regulation if, through inspection, it is determined that a person is providing services which would not conform in substantial part to the licensing requirements of this subtitle. D. A person who provides residential services to a child with a developmental disability shall meet the requirements of COMAR 14.31.05, 14.31.06, and 14.31.07, in addition to the requirements of this chapter. #### Regulation .02 Application for Initial License or Renewal. *COMAR 10.22.02.02* A. To obtain and maintain a license, an applicant shall, at a minimum: (1) Except for local health departments, be properly organized as a Maryland corporation, a forensic residential center (FRC), or a State residential center (SRC), or, if operating as a foreign corporation, be properly registered to do business in Maryland; (2) Have a governing body that is legally responsible for overseeing the management and operation of all programs conducted by the licensee; (3) Have a governing body that is legally responsible for ensuring that each aspect of the licensee's program operates in compliance with all of the requirements of this chapter and all other applicable laws and regulations; and (4) Except for currently licensed providers, demonstrate the capability to provide or arrange for the provision of all applicable services required by this chapter by submitting, at a minimum, the following documents to the Department: (a) A business plan that clearly demonstrates the ability of the applicant to provide services in accordance with this chapter; (b) A summary of the applicant's demonstrated experience in the field of developmental disabilities; (c) Prior licensing reports issued within the previous 10 years from any in-State or out-of-State entity associated with the applicant, including deficiency reports and compliance records; and (d) A written quality assurance plan approved by the Administration in accordance with Regulation .14 of this chapter; and (5) If currently licensed, produce, upon written request from the Administration, the document required under §A(4) of this regulation. B. An applicant shall file an application for a license or license renewal on a written or electronic form provided by the Administration. An existing licensee shall file an application for renewal at least 60 days before expiration of its existing license. The license does not expire until the Director takes an action under §D of this regulation and the time for seeking judicial review or any judicial stay of the final action expires. C. The administrative head of the corporation or two of its officers, local health officer, or SRC director, shall submit the application. D. When an application for initial licensure or renewal is submitted, the Director may: (1) Approve the application unconditionally and issue a license; (2) Approve the application with conditions and issue a license; (3) Deny the application for any reason including if an applicant has had a: (a) License revoked by the Department within the previous 10 years; or (b) Corporate officer who has served as a corporate officer for a licensee that has had a license revoked by the Department within the previous 10 years; or (4) Require additional information before a licensure decision is made. E. Hearing Request. (1) If the Director proposes to deny a license under this section, the Director shall notify the applicant in writing of the proposed decision and inform the applicant of the reason for the proposed denial and the right to a hearing. (2) A request for a hearing, including a copy of the Director's action, shall be filed with the Office of Administrative Hearings with a copy to the Administration not later than 30 days after receiving notice of the Director's proposed action. (3) A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 28.02.01 and 10.01.03. (4) The burden of proof is as set forth in COMAR 10.01.03.28. (5) Unless otherwise stated in this chapter, the Office of Administrative Hearings shall issue a proposed decision within the time frames set forth in COMAR 28.02.01. (6) The aggrieved person may file exceptions as set forth in COMAR 10.01.03.35. (7) A final decision by the Secretary shall be issued in accordance with COMAR 10.01.03.35. F. Voluntary Surrender of License. (1) If a licensee intends to voluntarily surrender its license, the licensee shall submit a closure schedule which the Director shall approve before the surrender becomes effective. (2) The licensee shall submit a schedule for closure to the Director, in writing, at least 90 days before surrendering its license. (3) The Director may grant the requested closure schedule as submitted, or require the licensee to continue to operate for an additional 90 days to allow the Administration time to plan for the continued provision of services to the individuals served by the licensee. (4) The Administration shall notify appropriate individuals and proponents of the licensee's intent to surrender its license and of the Director's approved closure schedule. G. The licensee may terminate services to an individual for good cause only with the written approval of the Director. The licensee shall: (1) Notify the Director in writing 90 days before the date it proposes to terminate services to an individual; (2) Notify the individual, and proponent, when appropriate, in writing, of its intent to terminate services and the individual's right to a hearing under COMAR 10.22.16, within the same time frame set forth in §G(1) of this regulation, and provide copies of that notice at that time to the appropriate regional office and members of the individual's team; and (3) Consider the service terminated, if an individual is absent from a service for 60 consecutive days, unless otherwise determined by the Director. #### Regulation .03 Investigation by the Administration. *COMAR 10.22.02.03* A. This regulation sets forth the roles of the Developmental Disabilities Administration and the Office of Health Care Quality in investigation and follow-up of reportable incidents. B. Licensee to be Open for Inspection. A licensee shall be open at all reasonable times to announced and unannounced inspections by the Administration or its designee. C. Records and Reports. A licensee shall maintain records and make reports as required by the Administration. The records and reports shall be open to inspection by the Administration. A licensee shall immediately, on request of the Administration, provide copies of the records and reports, including medical records of individuals, to the Administration. D. Protocol to Determine Necessity to Investigate. (1) The Administration, through its agent, the Office of Health Care Quality (OHCQ), shall investigate reportable incidents, events, or problems involving individuals in a community agency or State residential center based on the scope and severity in accordance with the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations. (2) The licensee shall report incidents in accordance with the requirements and timelines outlined in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations. (3) The necessity for investigation is determined by the following priorities: (a) Priority Level 1 — Immediate Jeopardy — Initiate investigation within 2 working days of receipt; (b) Priority Level 2 — High—Initiate investigation within 4 working days of receipt; (c) Priority Level 3 — Other Harm — Initiate an investigation within 30 working days of receipt; (d) Priority Level 4 — Administrative Review — Review during preparation for licensee's annual survey; (e) Priority Level 5 — Referrals — Refer to internal OHCQ unit or appropriate agency for follow-up within 1 working day; or (f) Priority Level 6 — Death — Upon notification, refer to the Mortality Review Unit of OHCQ within 1 working day for review and investigation. (4) Timelines for Specific Reports and Follow-Up Protocols. (a) The licensee shall submit a plan of correction (POC) within 10 working days of the receipt of deficiencies. The POC due date may be sooner than 10 working days when the nature of the deficiency warrants a more immediate response, as determined by the OHCQ and as outlined in Appendix 6 of the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations. (b) If the POC is determined to be acceptable, the OHCQ shall, whenever possible, within 10 working days of approving the POC, send the statement of deficiency and the POC to the: (i) Licensee who is required to share this information with the individual receiving services, who is the specific subject of a deficient practice, or to the resource coordinator, a guardian, or a family member as appropriate and set forth in the Developmental Disabilities Administration, Policy on Reportable Incidents and Investigations; (ii) Complainant; (iii) Agency's Executive Director and Board President; (iv) DDA Regional Office; (v) Maryland Disability Law Center when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations; (vi) Medicaid Fraud Control Unit of the Attorney General's Office when required by Developmental Disabilities Administration Policy on Reportable Incidents and Investigations; and (vii) Any other parties determined to be appropriate by OHCQ. (c) If the POC is determined to be unacceptable, the OHCQ shall, whenever possible, notify the agency in writing within 5 working days of receipt of the issues which require further review and consideration. The licensee shall resubmit to OHCQ a revised POC within 5 working days from notification of an unacceptable POC. (d) OHCQ shall conduct follow-up monitoring in accordance with Developmental Disabilities Administration Policy on Reportable Incidents and Investigations. E. Methods of Investigation. OHCQ shall conduct investigations through: (1) On-site inspections; (2) Interviews; or (3) Reviews of relevant records and documents. F. The licensee and OHCQ may receive extensions of the time periods set forth in this regulation for good cause shown. #### Regulation .04 Compliance Monitoring. *COMAR 10.22.02.04* A. The Administration, through its agent, the Office of Health Care Quality (OHCQ), is responsible for monitoring and inspecting the Administration's licensees to ensure regulatory compliance. B. The Administration shall conduct an on-site pre-licensure survey. C. The Administration shall conduct announced and unannounced licensure visits at any time the Administration considers necessary, but at least annually, and provide the licensee with any notification of noncompliance. D. The Administration shall conduct announced or unannounced complaint investigation visits at any time the Administration considers necessary and provide the licensee with notification of any noncompliance. E. The licensee shall submit a plan of correction (POC) at the end of an exit conference, or within 10 working days of receipt of the findings of noncompliance. The POC due date may be sooner than 10 working days when the nature of the noncompliance warrants a more immediate response, as determined by the OHCQ. The Director of the OHCQ may grant an extension of not more than 30 days for the submission of the POC. F. If a POC is deemed unacceptable by the OHCQ, the licensee shall resubmit a revised POC within 10 working days to the OHCQ for approval. #### Regulation .05 New Site, Site Closure, or Relocation. *COMAR 10.22.02.05* A. A licensee may not open, close, or relocate any site without approval of the Administration. If a licensee intends to open, close, or relocate any site, the licensee shall request approval from the Administration and submit documentation as required by the Administration at least 30 days before the date the licensee intends to make the change. B. If a licensee is required to open, close, or relocate a site due to an emergency and the notice requirements set forth in §A of this regulation cannot be met, the licensee shall notify the regional director as soon as the change occurs. The regional director shall notify the OHCQ of this change. The OHCQ shall ensure that the change meets with its approval. #### Regulation .06 Licensed Capacity. *COMAR 10.22.02.06* A. A license issued by the Administration shall include the number of individuals for whom the licensee is permitted to provide services. B. A licensee may exceed its licensed capacity only if the Director: (1) Requests in writing that the licensee exceed its licensed capacity; or (2) Approves a written request from a licensee to exceed its licensed capacity. C. A licensee shall include in its written request to exceed its licensed capacity: (1) The circumstances or reasons for the request; (2) The identity of all individuals involved; and (3) Documentation that all individuals involved have been informed of the plan to exceed licensed capacity. D. Permission to exceed licensed capacity shall be: (1) Granted for not more than 60 days; and (2) Extended for not more than an additional 60 days. #### Regulation .07 Individual Family Care (IFC). *COMAR 10.22.02.07* A. On the effective date of this chapter, a community residential licensee providing IFC services may not contract with an IFC care provider who has a contract with another community residential licensee who provides IFC services. B. Notwithstanding §A of this regulation, an individual who is receiving services in an IFC home before the effective date of these regulations may continue to receive services in that home. #### Regulation .08 Governing Body. *COMAR 10.22.02.08* A. A local health department's governing body is the governing body of the respective county as set forth in Health-General Article, Title 3, Subtitle 3, Annotated Code of Maryland. B. Except for local health departments, forensic residential centers (FRCs), and State residential centers, the governing body of all licensees shall include, at a minimum, at least one individual with a developmental disability, one family member of an individual with a developmental disability, and an individual with experience in the field of developmental disabilities. C. Except for local health departments, forensic residential centers (FRCs), and State residential centers, the governing body of all licensees shall adopt written bylaws which require the governing body to be legally responsible for: (1) Overseeing the management and operation of the licensee; (2) Ensuring that the licensee operates in compliance with all of the requirements of this chapter and all other applicable laws and regulations; (3) Approving a licensee's mission statement, long-range goals, policies, procedures, and budget; (4) Defining and prohibiting those circumstances which would create a financial or personal conflict of interest for members of the governing body, staff, care providers, volunteers, and members of the standing committee; (5) Ensuring that the licensee responds to all POCs in a timely manner; (6) Approving a licensee's program service plan and ensuring that its services are provided in accordance with the plan; (7) Ensuring that at least 75 percent of the governing body of a licensee shall be residents of the State or reside within a 100 mile radius of the administrative offices of the licensee, which shall be located in the State unless the licensee: (a) Has established an Administration approved community-based advisory board or committee; and (b) Receives an Administration approved waiver; (8) Ensuring that no employee of a licensee or immediate family member of an employee of a licensee may serve as a voting member of the governing body of the licensee unless: (a) The employee receives services from the licensee; or (b) The Administration approves the composition of the governing body through an innovative program services plan in accordance with Regulation .09 of this chapter; and (9) Ensuring that by January 1, 2008, members of the governing body and employees of the licensee may not own property that is leased back to the licensee. #### Regulation .09 Program Service Plan (PSP). *COMAR 10.22.02.09* A. To receive a license from the Administration under this chapter, the applicant shall develop and submit for approval, as part of its application, a PSP for each service it provides. B. If the licensee makes a change in its PSP, the licensee shall submit its revised PSP for the Administration's approval before the implementation of the changes. C. The administrative head of the licensee shall assure that the PSP is reviewed by its governing body and updated at least every 3 years. D. The licensee shall comply with all provisions of its approved PSP. E. Contents. The licensee shall ensure the PSP includes the following components: (1) Rationale, which includes a discussion of the applicant's philosophy for the provision of services; (2) Scope, which includes a discussion of the specific services to be provided; (3) Staffing and training, which includes a description of the staff or care providers necessary to provide the services outlined in §E(2) of this regulation and a description of any additional training required by its staff other than provided in Regulation .11 of this chapter; and (4) Setting and location, which includes a description of where the services are to be provided and the number of individuals expected to be served. F. Innovative Program Service Plan Variance. (1) If an applicant or licensee wants to provide services or supports through an alternative model not currently regulated by this subtitle, the applicant or licensee may submit a PSP and request approval from the Administration to provide services or supports through this alternative model. (2) The Administration shall consider whether the proposed model meets the overall goals of the Administration and reflects the values and outcomes delineated in COMAR 10.22.04. (3) The Administration may approve the proposed model, as proposed, or with conditions, including which regulatory requirements of this subtitle would apply. #### Regulation .10 Policies and Procedures. *COMAR 10.22.02.10* A. A licensee shall develop and adopt written policies and procedures for ensuring: (1) That each individual's health and safety needs, as identified in the individual plan (IP), are being met; (2) Fundamental rights in accordance with Health-General Article, §7-1002, Annotated Code of Maryland; (3) That services are provided in a manner which promotes individual choice and the exercise of individual rights; (4) Confidentiality for each individual in accordance with Health-General Article, §7-1010, Annotated Code of Maryland; (5) The implementation of a grievance process with safeguards which protect against retaliatory actions for the filing of any grievance; (6) That services are provided without discrimination; (7) That all incidents, including those involving life-threatening conditions, are reported and investigated in accordance with the Administration's procedures on reportable incidents; (8) That medications are administered in accordance with the practices established by the Administration's curriculum on medication training; (9) Compliance with COMAR 10.27.11; (10) That an individual whose behavior requires intervention receives the safeguards required by this regulation; (11) That in order for an individual to be required to pay for property damage caused by the individual's actions, the individual's IP shall show evidence that the: (a) Individual has a history of destructive behavior that has been documented in the behavior plan (BP), (b) Individual has a BP that addresses the destructive behavior, (c) Individual has the ability to pay for damages, (d) Licensee's standing committee, as described in Regulation .08 of this chapter, has reviewed and approved the damage payment, and (e) Licensee has reported this approval to the regional director; (12) Compliance with Health-General Article, §5-605, Annotated Code of Maryland; (13) That there is no financial or personal conflict of interest for members of the governing body, staff, care providers, volunteers, and standing committee members; (14) That the fiscal affairs of the licensee are conducted in accordance with generally accepted accounting practices; (15) That there is adequate protection for the finances and property of each individual, including: (a) A system to ensure that each individual's funds are used in an appropriate manner consistent with the individual's needs and preferences, (b) A system to keep personal funds separate from the funds of the licensee and to ensure that funds are transferred to the individual in a timely manner when services are no longer being provided, (c) Timely access for the individual to the funds, (d) An accounting of the individual's funds, on request, and (e) The accrual of any interest into the individual's account from an interest-bearing account; (16) That State and federally required safety precautions, infection control, and standard precautions are implemented; (17) That an effective disaster and emergency evacuation plan, with sufficient evacuation drills is in place; (18) That an individual may not perform the duties of a paid staff person; and (19) That an individual only perform those duties and tasks that are shared by the household or included as an activity documented in the individual's IP or remunerated as part of a training program as required by federal or State law. B. A licensed community residential service provider offering services in alternative living units or group homes shall develop an emergency plan for all types of emergencies and disasters that shall include: (1) Procedures that will be followed before, during, and after an emergency to address the following: (a) The evacuation, transportation, or 72 hour shelter-in-place of individuals and staff served; (b) Holding an annual practice drill coordinated with local emergency planners for sheltering in place or evacuating; (c) Preparing an after action report and improvement plan after drills that evaluates the plan and takes corrective actions; (d) Ensuring that individuals served and staff have identification with current health, contact, and other important information that is immediately accessible in the event of evacuation; (e) The role of the resident, family member, or legal representative in the event of evacuation; (f) Arranging for medical needs and other accommodations for individuals served and staff at alternative facilities or shelters; and (g) Establishing a communication protocol among all appropriate parties that includes redundant communication means; (2) The notification to families, staff, and the respective DDA regional office (licensing authority) regarding the action that will be taken concerning the safety and well-being of the individuals served; (3) The staff coverage, organization, and assignment of responsibilities that includes: (a) Planning staff coverage needs for ongoing shelter in place or evacuations; (b) Identifying staff members available to report for work or remain during extended periods; and (c) Establishing staff notification and recall contingency plans and procedures; (4) The continuity of operations, including, but not limited to, redundant communications systems, preservation of records and electronic data, the procurement of essential goods, equipment, and services, plans to secure vacated facilities, and the relocation to alternate facilities; (5) Procedures to: (a) Backup and electronically store off-site, appropriate records and data of consumers and staff and facility documents, for access under emergency conditions; (b) Ensure access to an electronic copy of the emergency plans when requested by local, State, or federal emergency management organizations; (6) Provisions to ensure that the facility's emergency and disaster plans are shared with local emergency management organizations for the purpose of coordinating local emergency planning; and (7) An executive summary of the evacuation procedures that shall be provided to the family member of a resident on request. C. The licensee shall ensure that all staff, care providers, consultants, and volunteers are aware of the policies required by this chapter and that all staff, care providers, consultants, and volunteers implement each policy as adopted. D. The licensee shall ensure that it provides sufficient information about its grievance process to each individual it serves and, when appropriate, to the individual's proponent, to enable the individual or proponent to use the process effectively. #### Regulation .11 Staffing Requirements. *COMAR 10.22.02.11* A. Following an analysis of the number of individuals the licensee intends to serve and the needs of each of these individuals being served, the licensee shall develop and implement a staffing plan that adequately addresses the health and safety needs of each individual and provides each individual with the services identified in the IP. The staffing plan may include any person who meets the training requirements of this regulation and who does not have a criminal history as set forth in §B of this regulation. A staff person who meets the above criteria may assume all responsibilities previously assigned to a qualified developmental disabilities professional. B. A licensee may not employ or contract with any person who has a criminal history which would indicate behavior potentially harmful to individuals, documented through either a criminal history records check or a criminal background check, pursuant to Health-General Article, §19-1902 et seq., Annotated Code of Maryland, and COMAR 12.15.03. C. The licensee shall develop and implement staff and care provider training and ensure through appropriate documentation that, before being assigned independent duties: (1) All staff and care providers receive adequate training to perform their assigned duties; (2) All staff and care providers successfully complete the Administration's approved training to meet the specific needs of the individuals they serve and to carry out their assigned duties, such as training in: (a) Seizure disorders, (b) Principles of behavior change, (c) Management of disruptive behaviors, (d) Medication administration, and (e) The aging process and the special needs of the elderly; and (3) All staff and care providers receive training in blood-borne pathogens in accordance with OSHA guidelines found in 29 CFR §1910.1030, which is incorporated by reference. D. All staff and care providers shall receive Administration-approved training within 3 months of hire in the following: (1) Community integration and inclusion, (2) Individual-directed, outcome-oriented planning for individuals, (3) General characteristics and needs of individuals served, (4) First aid and cardiopulmonary resuscitation (CPR), based on the guidelines of the American Red Cross or another nationally recognized organization, (5) Fundamental rights of individuals with developmental disabilities, (6) Communicable diseases, (7) Supporting individuals and families in making choices, and (8) Communication skills. E. A licensee shall develop and adopt: (1) Written job descriptions that include the nature and extent of training and experience required for each position; and (2) A policy to prevent employment discrimination. #### Regulation .12 Health and Safety Requirements. *COMAR 10.22.02.12* A. To obtain and maintain licensure, a licensee shall ensure that any licensed home or site in which the licensee provides services to individuals: (1) Meets local zoning requirements, except as otherwise set forth in Health-General Article, §7-603, Annotated Code of Maryland; (2) Meets local and State building requirements; (3) Meets applicable life safety requirements; (4) Is free from safety and health hazards; and (5) Is in good repair. B. A licensee shall ensure that any licensed home or site in which the licensee provides services is free from fire hazards and has the following minimum fire safety protections: (1) Adequate smoke detectors; (2) Working and updated fire extinguishers; and (3) A written fire evacuation plan, as required by Regulation .10A(17) of this chapter. C. A licensee shall ensure that any licensed home or site in which the licensee provides services to individuals maintains its water temperature at a maximum of 110ºF, unless: (1) Each individual living in the home or receiving services at the site is capable of regulating water temperature safely; and (2) There is documentation of the capability required in §C(1) of this regulation in each individual's IP. D. In order to ensure the health and safety of individuals who require staff assistance in the administration of medication, the licensee shall: (1) Require that all medication be administered in accordance with the Administration's curriculum on medication training; (2) Provide oral, solid medications in a unit dose package unless an individual's IP indicates that this is not required; (3) Provide medication for an individual who is absent from a program in a separate, pharmaceutically prepared package that is easily identified by the individual administering the medication; and (4) Request, from the pharmacy, computer-generated medication administration records, treatment administration records, and physician medication order forms. #### Regulation .13 Records. *COMAR 10.22.02.13* A. A licensee shall maintain records for each individual at the site where the individual is being served. B. The records shall include at a minimum: (1) The identifying information which appears on the individual's application for services from the Administration; (2) Sufficient information that enables the licensee to provide services in a manner which ensures the individual's health and safety, including: (a) An emergency contact person for the individual, (b) The names of the individual's next of kin, (c) The individual's physician, (d) The individual's current diagnosis, (e) Documented allergies of the individual, and (f) A listing of the medications the individual receives; (3) The IP as defined in COMAR 10.22.05; (4) Documentation demonstrating implementation of the IP; and (5) Any other information the Administration may require. C. On notification of a medical emergency, the licensee shall ensure that the individual's medical information is available and readily accessible to emergency personnel. D. The licensee shall: (1) Maintain an individual's records for a minimum of 6 years, regardless of whether the individual is no longer being served or dies; (2) Maintain documents relevant to the services the individual is currently receiving, as long as the individual is being served; and (3) Organize an individual's record in a manner that facilitates easy access to needed information. E. Electronic Records. (1) The licensee is encouraged to use electronic records whenever possible. (2) Electronic records shall: (a) Meet requirements in this chapter; (b) Comply with the HIPAA privacy and security rules pertaining to personal health information (PHI); and (c) Be properly backed up and stored at an off-site location. #### Regulation .14 Quality Assurance. *COMAR 10.22.02.14* A. The licensee shall submit a quality assurance plan and any subsequent substantive changes to the plan to the Administration for approval. B. The licensee shall develop and implement a system of internal quality assurance which at a minimum: (1) Is focused on the individual's choices, preferences, and satisfaction, and includes personal contact with the individuals being served; (2) Has outcomes and results that are measurable and may be incorporated into future IPs for the individuals being served; (3) Has outcomes and results that are measurable and may be incorporated into systemic changes in a licensee's operation; (4) Collects and evaluates data and analyzes trends identified through quality assurance activities including: (a) The name of the individual with a behavior plan, (b) The medication or other restrictive technique used, (c) The date and time the restrictive technique was used, (d) Whether the medication or other restrictive technique was used as an emergency or as part of a behavior plan, and (e) Whether the medication or other restrictive technique used is meeting the goals and objectives established in the behavior plan; (5) Provides for prompt and appropriate response when an individual's health or safety is at risk; and (6) Includes proactive strategies to improve the quality of services, including health and safety. C. The licensee shall: (1) Establish goals and standards to measure the quality of services being delivered and define how the standards are measured; (2) Maintain records to demonstrate the effectiveness of its quality assurance activities; (3) Implement changes based on the results of the evaluated data; and (4) Be held accountable by the Administration for accomplishing the goals and standards that are established as part of the licensee's system of quality assurance. D. The Administration may request documentation from a licensee to verify that the licensee is accomplishing the goals and standards set forth in the licensee's quality assurance plan. E. Standing Committees. (1) The licensee shall establish a committee or committees to perform the following functions: (a) Perform the quality assurance functions set forth in this regulation; (b) Review the licensee's protocol for identifying, reporting, documenting, investigating, and reviewing of incidents to ensure compliance with Administration procedures; (c) Monitor whether the licensee's protocol identified in §E(2) of this regulation is being properly implemented by reviewing all incidents in an effort to identify deficient practices and recommend necessary corrective action; (d) Approve all behavior plans which use restrictive techniques to ensure that the behavior plan complies with the requirements of COMAR 10.22.04.03A and 10.22.10; (e) Review, approve, and establish the time frame for the restriction of a right if it is not related to a challenging behavior, in accordance with COMAR 10.22.04.03A; and (f) Review the licensee's policies and procedures, and implementation of them, to ensure that they adequately protect the legal and human rights of each individual served by the licensee. (2) The committee or committees may be organized to perform the functions set forth in §A of this regulation for one or more licensees. (3) The committee or committees shall include an equal number of licensee staff, and individuals, proponents, or members of the community who are not employed by the licensee. For a committee member who is remunerated only to serve as a member of the committee, that member is not counted as staff or as a member of the community. (4) The committee or committees may consult with a licensed health professional such as a psychologist, physician, physician's assistant, nurse practitioner, or board-certified clinical pharmacist, as needed. (5) A committee member may not participate in the decision making process of any: (a) Incident in which the committee member was involved; or (b) Behavior plan the committee member has developed. (6) The committee or committees shall meet as needed to perform the functions identified in §E(1) of this regulation, with, at least, a majority of members present. (7) The committee or committees shall ensure confidentiality for the individual in accordance with Health-General Article, §7-1010, Annotated Code of Maryland. ### Chapter 03 — Procedures for License Denials and Disciplinary Sanctions **Authority:** Health-General Article, §7-904, Annotated Code of Maryland **Administrative History:** Effective date: January 7, 1974 **Administrative History:** Regulations .01 — .27 amended effective July 25, 1980 (7:15 Md. R. 1425) **Administrative History:** Regulations .01 — .27, Group Homes for the Mentally Retarded, repealed effective September 21, 1986 (13:19 Md. R. 2121) **Administrative History:** Regulations .01 — .07, Community Residential Services for Mentally Retarded and Nonretarded Developmentally Disabled Individuals, adopted effective September 12, 1986 (13:19 Md. R. 2121) **Administrative History:** Chapter revised effective December 26, 1988 (15:26 Md. R. 2983) **Administrative History:** Chapter, Community Residential Services for Individuals with Developmental Disability, repealed and new chapter, General Provisions for Sanctions and Appeals, adopted effective July 26, 1999 (26:15 Md. R. 1148) #### Regulation .01 Purpose. *COMAR 10.22.03.01* This chapter describes the procedures for a license denial and disciplinary action against a licensee. #### Regulation .02 Definitions. *COMAR 10.22.03.02* A. In addition to the definitions set forth in COMAR 10.22.01, in this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Isolated scope” means that the identified deficiency has occurred only once, in only one location, or for only one individual. (2) “Low scope” means that the deficiency has occurred only occasionally, in sporadic locations, or for only a few individuals. (3) “Minor impact” means there has been little or no negative effect on an individual's health, safety, rights, or quality of life. (4) “Moderate impact” means an individual has experienced a significant health or safety consequence, a violation of rights, or infringement on quality of life, or that these consequences may likely occur in the near future. (5) “Repeated scope” means that the deficiency has occurred on a regular basis, in several locations, or for several individuals. (6) “Severe impact” means an individual has experienced a deterioration in the individual's medical or psychological condition, has been exposed to a serious safety risk, has experienced frequent rights violations, or infringements on the individual's quality of life, or that these consequences may likely occur in the near future. (7) “Widespread scope” means that the deficiency has occurred consistently, in most locations, or for a majority of people. #### Regulation .03 Failure to Submit Acceptable Plan of Correction. *COMAR 10.22.03.03* A licensee, including a licensee with deficiencies having only a minor impact, is subject to any intermediate sanction set forth in Regulation .04 of this chapter for failure to comply with COMAR 10.22.02.04E and F. #### Regulation .04 Intermediate Sanctions. *COMAR 10.22.03.04* A. After notice and an opportunity for a hearing, the Director may impose any intermediate sanctions listed in §B of this regulation if: (1) Deficiencies have a moderate impact and the scope of the deficiencies occurs on an isolated, low, repeated, or widespread basis; or (2) Deficiencies have a severe impact and the scope of the deficiencies occurs on an isolated, low, repeated, or widespread basis. B. For purposes of §A of this regulation, intermediate sanctions include: (1) A directed plan of correction, when the licensee is directed to take a specific action by a certain date; (2) A mandatory staffing pattern, when the Administration defines for the licensee the level of individual supervision required at a particular site or program; (3) Mandatory training, when the Administration identifies deficient areas in which training is needed; (4) Individual relocation, when the Administration reserves the right to relocate an individual to another licensee in order to protect the health or safety of the individual; (5) Expansion ban, when the Administration retains the authority to prohibit the licensee from obtaining additional sites, admitting individuals, or providing additional services at the site; (6) Imposition of an intensive monitoring protocol by the Administration; or (7) Imposition of a temporary site monitor, when the Administration maintains an on-going physical presence for the purpose of providing assistance and evaluating the extent of the licensee's corrective actions. #### Regulation .05 Summary Suspension. *COMAR 10.22.03.05* A. Pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, and if appropriate, after a pre-deprivation hearing, the Director may summarily order the suspension of a license if the Administration finds that the public health, safety, or welfare imperatively requires emergency action. B. The Director shall notify the licensee in writing of the suspension, the findings, and the reasons that support the findings, and, when appropriate, the opportunity for a pre-deprivation hearing. The notice shall include: (1) The proposed order for summary suspension which includes: (a) The statutory and regulatory authority upon which the order is based, (b) The facts supporting the alleged violations of law, (c) The facts supporting the belief that there is an imminent danger to the health, safety, and welfare of individuals, and (d) The licensee's right to appeal the summary suspension, if executed by the Director; and (2) A show cause notice providing an opportunity for the licensee to show cause as to why the order should not be issued if the public health, safety, and welfare permits. C. The Director may suspend a license without prior notice and the opportunity to be heard if: (1) The Director determines that the health, welfare, and safety of the public imperatively requires immediate suspension; (2) Notice of an opportunity to be heard before the action is not feasible; and (3) The Administration provides the licensee with a post-deprivation hearing opportunity within 15 working days of the suspension. D. The Administration shall: (1) Notify the individuals being served by the licensee and, if appropriate, their families or proponents, regarding the summary suspension; and (2) Assist the individuals in finding alternative services if the license is summarily suspended. #### Regulation .06 Denial, Probation, Suspension, or Revocation. *COMAR 10.22.03.06* A. In addition to any intermediate sanctions, the Director may deny a license or take disciplinary action against a licensee if: (1) An applicant fails to meet the regulations governing the services for which it is applying for a license; (2) A licensee fails to comply with the regulations governing its services; or (3) A licensee fails to cooperate with the Department during an investigation or licensing survey. B. If the Director proposes to deny approval to an applicant or take disciplinary action against a licensee, the Director shall give written notice to the governing body, the executive director, the regional director, the Health Care Financing Administration, and, as appropriate, other interested parties. C. In the written notice under §B of this regulation, the Director shall include: (1) The statutory and regulatory authority upon which the proposed action is based; (2) The facts supporting the alleged violations of law; and (3) The applicant's or licensee's right to a hearing under Regulation .07 of this chapter before final action. #### Regulation .07 Procedures for Hearings. *COMAR 10.22.03.07* A. If the Secretary proposes to deny a license or take disciplinary action against a licensee, the Director shall give the licensee written notice according to Regulation .06 of this chapter. B. Within 10 working days of receipt of the notice, the governing body or health officer may file a written request for a hearing with the Office of Administrative Hearings with copies of the request to the: (1) Director; (2) Regional director; and (3) Administrative prosecutor. C. If the governing body or the health officer does not file a request for a hearing within 10 working days of receipt of the notification, the licensee waives its right to request a hearing, and the Director may implement the proposed action. D. If a timely request for a hearing has been received, the Office of Administrative Hearings shall: (1) Notify the Director, the governing body or health officer, the regional director, and administrative prosecutor of the date, time, and location of the hearing; and (2) In accordance with COMAR 28.02.01, hold a hearing and, unless the final decision is delegated to the Office of Administrative Hearings, render a proposed decision to the Director. E. After giving the parties the opportunity to file exceptions under the provisions of State Government Article, §10-216, Annotated Code of Maryland, the Secretary shall issue a final decision according to State Government Article, §10-221, Annotated Code of Maryland, and send notice to the: (1) Governing body or the health officer; (2) Regional director; (3) Medical Care Programs; (4) Individual and, if appropriate, their family or proponents; and (5) Health Care Financing Administration. F. A licensee may appeal a final decision from a contested case by following the provisions of Health-General Article, §2-207, and State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. G. In addition to disposing of a case by a hearing, the Director may dispose of a contested case by: (1) Stipulation; (2) Settlement; (3) Consent order; (4) Default; (5) Withdrawal; (6) Summary disposition; or (7) Dismissal. H. If disciplinary action is taken against a licensee, the Director shall notify the appropriate parties which include, but are not limited to the: (1) Health Care Financing Administration; (2) Medical Care Programs; (3) Licensing and Certification Administration; (4) MDH Corporate Compliance Office; and (5) Maryland Disability Law Center. ### Chapter 04 — Values, Outcomes, and Fundamental Rights **Authority:** Health-General Article, §7-904, Annotated Code of Maryland **Administrative History:** Effective date: July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .01 amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100) #### Regulation .01 Scope. *COMAR 10.22.04.01* This chapter identifies the values and outcomes that enhance the quality of life for individuals who are receiving services in the SRCs, FRCs, and the community. It is understood, however, that all of the referenced outcomes might not be evident in the lives of all individuals at all times. The licensee shall make every effort to facilitate the achievement of these outcomes. It is understood, however, that the achievement of these outcomes may be influenced by the needs, preferences, and desires of an individual, health and safety considerations, or fiscal limitations. #### Regulation .02 Values to be Considered in the Development of the IP. *COMAR 10.22.04.02* The following values shall be considered in the development of the IP: A. Personal well-being, which includes: (1) Receiving health care services that respond to the individual's needs and are consistent with those of the general population; (2) Living and working in places that are safe; (3) Having access to the places in which the individual lives, works, and receives services; (4) Having continuity and security; (5) Having one's basic needs met; and (6) Having the time, space, and opportunity for privacy; B. Individual rights, which include: (1) Having the same rights and protections as all other citizens under the laws and Constitution of Maryland and the United States; (2) Having religious and cultural beliefs respected; (3) Being free from abuse, neglect, and mistreatment; (4) Having personal information kept in confidence; (5) Living, working, and receiving services in a manner that is not unnecessarily restrictive; (6) Having one's money and belongings secured; and (7) Having access to one's money and belongings; C. Choice and control, which includes: (1) Being given the opportunity to express choices and opinions; (2) Having choices about the following: (a) Where to live and with whom, (b) The appearance of one's home, (c) The services one receives and from whom, (d) How one spends one's time and with whom, (e) How menus, activities, schedules, and routines are structured, (f) Who advocates for the individual; and (3) Having one's choices and opinions respected and addressed; D. Respect and dignity, which includes: (1) Being treated with courtesy and respect; (2) Being treated with warmth and caring; (3) Receiving positive recognition; (4) Being spoken to and treated in an age-appropriate manner; and (5) Living and working in places that reflect things that are valued; E. Personal growth and independence by: (1) Having the opportunity to develop personal goals and the opportunity to work toward achieving those goals; (2) Receiving the supports to succeed where one chooses to live and work; (3) Receiving the education, habilitation, and the opportunities for increased independence; (4) Having access to technology to assist in living and learning; (5) Having the opportunity to manage one's own affairs, including financial affairs as much as possible; and (6) Having the opportunity to participate in individual activities; F. The opportunity for relationships by: (1) Having the opportunity to develop and maintain meaningful ties to other people; (2) Having relationships encouraged and supported; (3) Having the opportunity to be connected to family and friends; and (4) Having the opportunity for intimacy; and G. Community membership and social inclusion by: (1) Having the opportunity to be involved in and contribute to the community; (2) Having the opportunity to participate in community activities of one's choice; (3) Having the opportunity to use the same resources as other people; and (4) Having regular access to recreation and leisure time activities with others. #### Regulation .03 Fundamental Rights. *COMAR 10.22.04.03* A. Each individual is entitled to the basic rights set forth in Health-General Article, §§7-1002 — 7-1004, Annotated Code of Maryland, unless the individual's team decides it is necessary to restrict a right. If the restriction is due to a challenging behavior, the licensee shall follow the procedures outlined in COMAR 10.22.10. If it is necessary to restrict a right not related to a challenging behavior, the standing committee shall review, approve, and establish the time frame for the restriction. The licensee shall: (1) Document in the IP the: (a) Right being restricted, (b) Reason for the restriction, (c) Conditions under which the restriction is employed, (d) Efforts to restore the right to the individual, and (e) Conditions under which the right would be restored; (2) Comply with COMAR 10.22.10.06D and E; and (3) Ensure that the restriction: (a) Represents the least restrictive, effective alternative, and (b) Is only implemented after other methods have been systematically tried and objectively determined to be ineffective. B. Each licensee shall provide for the preservation of each individual's fundamental rights in accordance with Health-General Article, §7-1003, Annotated Code of Maryland. C. Each licensee shall ensure that the individual and the individual's family is made aware of and given a copy of these rights, and that they are posted in accordance with Health-General Article, §7-1002, Annotated Code of Maryland. ### Chapter 05 — The Individual Plan **Authority:** Health-General Article, §§7-1002 and 7-1006, Annotated Code of Maryland **Administrative History:** Effective date: April 13, 1977 (4:8 Md. R. 643) **Administrative History:** Regulations .01 — .06 repealed effective November 14, 1988 (15:23 Md. R. 2659) **Administrative History:** Regulations .01 — .09, Individualized Habilitation Plans, adopted effective November 14, 1988 (15:23 Md. R. 2659) **Administrative History:** Chapter, Individualized Habilitation Plans, repealed and new chapter, The Individual Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .01 amended as an emergency provision effective July 10, 2008 (35:16 Md. R. 1388); emergency status extended at 36:2 Md. R. 96; amended permanently effective January 26, 2009 (36:2 Md. R. 100) **Administrative History:** Regulation .02B amended effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .03A amended effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .03C adopted effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .04D adopted effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .05 amended effective May 5, 2008 (35:9 Md. R. 897) #### Regulation .01 Rationale. *COMAR 10.22.05.01* Through an individual directed approach, each individual, with assistance from the individual's team, is the designer of the services and supports reflected in the individual plan (IP). The provision of these services and supports may be influenced by health and safety considerations or resource limitations. This chapter applies to individuals living in the community, FRCs, and SRCs. #### Regulation .02 Components of the IP. *COMAR 10.22.05.02* A. The IP is: (1) A single plan for the provision of services and supports to the individual; (2) Directed by the individual; (3) Outcome oriented; and (4) Intended to specify all needed assessments, services, and training. B. The IP is a written plan which includes: (1) Strengths and needs of the individual; (2) Preferences and desires identified by and for the individual; (3) Services to be provided to the individual by the licensee, such as: (a) Habilitation; (b) Medical; (c) Occupational therapy; (d) Physical therapy; (e) Social; (f) Psychological; (g) Audiological; (h) Speech and language; (i) Nursing; (j) Assistive technology; and (k) Additional services to support an individual in retirement; (4) A behavior plan, if required; (5) Specific training and staffing ratios based on the needs, preferences, and desires of the individual; (6) Measurable goals for the completion of outcomes; (7) Target dates for the completion of goals; (8) Implementation strategies and dates; (9) Documentation of progress toward the achievement of goals; (10) Monitoring procedures; (11) Individuals responsible for providing the supports, services, implementation, and monitoring of the plan; (12) Documentation indicating that the individual or the individual's proponents, when applicable, have been involved in, informed of, and agree with the plan; (13) A determination of whether the needs of the individual could be met in more integrated settings; and (14) For individuals residing in a State residential center, the written plan of habilitation consisting of: (a) The treating professional's recommendation on the most integrated setting appropriate to meet the individual's needs; (b) The resource coordinator's recommendation on the most integrated setting appropriate to meet the individual's needs; (c) A description of the services and supports, including residential, day, employment, and technology, that are required for the individual to receive services in the most integrated setting; (d) A listing of barriers that prevent the individual from receiving supports and services in the most integrated setting, including community capacity or systems, if community services are determined to be the most integrated setting appropriate to meet the individual's needs; and (e) An annual update on the status and progress toward addressing and resolving any identified barriers to receiving supports and services in the most integrated setting. #### Regulation .03 Development and Implementation. *COMAR 10.22.05.03* A. The resource coordinator, as defined in COMAR 10.22.09, shall ensure that: (1) Each individual, other than an individual receiving respite services in the community, has an IP that is developed not more than 30 calendar days after receiving services; (2) The IP is developed in a manner consistent with the values and outcomes in COMAR 10.22.04, and the provisions of any other relevant State or federal laws; (3) Each individual is provided with a range of the most integrated setting service options that may be appropriate; and (4) The IP meetings are held at a time and place convenient to the individual. B. If the individual does not have a resource coordinator, the licensee, in the following priority order, shall ensure that the requirements of this chapter are met: (1) Community residential services licensee; (2) Vocational or day services licensee; or (3) Family and individual support services licensee. C. Written Plan of Habilitation for Individuals Residing in State Residential Center. (1) The individual, a treating professional, and a resource coordinator shall develop the written plan of habilitation. (2) On an annual basis and any other time requested by the individual, the treating professional and the resource coordinator shall discuss with the individual: (a) The service and support needs of the individual; (b) A range of the most integrated setting service options licensed through the administration that may be appropriate; and (c) Any identified community-based Medicaid waiver services and any other services and supports that may be appropriate. (3) The treating professionals and resource coordinator shall use any communication devices and techniques, including the use of sign language, as appropriate, to facilitate the involvement of the individual in the development of the written plan of habilitation. #### Regulation .04 Decisions. *COMAR 10.22.05.04* A. The team shall make decisions by consensus. B. If the team cannot reach a consensus, the resource coordinator shall mediate and resolve the issue of concern. C. If the resource coordinator cannot resolve the issue or if there is not a resource coordinator on the team, the appropriate regional director shall mediate and resolve the issue of concern. D. For individuals residing in a State residential center: (1) If the team cannot reach consensus, the facility director shall mediate and resolve the issue of concern; and (2) If consensus still cannot be achieved, the regional director shall mediate and resolve the issue of concern. #### Regulation .05 Review of the IP. *COMAR 10.22.05.05* A. Each IP shall be reviewed and approved, disapproved, or modified by: (1) The executive officer or administrative head of the licensee or a qualified developmental disability professional whom the executive officer or administrative head designates; and (2) One other professional individual who is responsible for carrying out a major program but does not participate in the IP. B. Approval of an IP shall be based on the current needs of the individual. C. The team shall review each IP at least annually, or more often as needed, and modify each IP as required by the individual's circumstances. D. Any member of the team may request a review or modification of the IP at any time. #### Regulation .06 Implementation. *COMAR 10.22.05.06* The licensee shall implement the supports and services that the licensee has agreed to provide, as indicated in the IP, within 20 calendar days. ### Chapter 06 — Family and Individual Support Services (FISS) Program Service Plan **Authority:** Health-General Article, §§7-703, 7-708, and 7-904, Annotated Code of Maryland **Administrative History:** Effective date: March 7, 1980 (7:5 Md. R. 474) **Administrative History:** Regulations .01 — .09, Respite Care Services in Public Residential Care Facilities Serving the Mentally Retarded, repealed effective June 13, 1988 (15:12 Md. R. 1445) **Administrative History:** Regulations .01 — .08, Respite Care Services in State Residential Centers Serving Individuals with Mental Retardation, adopted effective June 13, 1988 (15:12 Md. R. 1445) **Administrative History:** Chapter, Respite Care Services in State Residential Centers Serving Individuals with Mental Retardation, repealed and new chapter, Family and Individual Support Services Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148) #### Regulation .01 Additional Regulatory Compliance. *COMAR 10.22.06.01* In addition to this chapter, a person who provides FISS to an individual shall comply with the following regulations of this subtitle: A. COMAR 10.22.01; B. COMAR 10.22.02, with the exception of COMAR 10.22.02.06; C. COMAR 10.22.03; D. COMAR 10.22.04; E. COMAR 10.22.05; and F. COMAR 10.22.10, when applicable. #### Regulation .02 Rationale. *COMAR 10.22.06.02* A. Services are to be flexible and dynamic to meet the needs of individuals or families desiring specific areas of support and for those who have changing needs. B. Services are to be readily adaptable to the changing needs of the individual. C. The flexibility inherent in FISS lends itself to creative and innovative ways of supporting individuals and their families. #### Regulation .03 Scope. *COMAR 10.22.06.03* A. FISS cover a wide array of supports in the life of an individual. B. FISS are provided by making use of resources available in the community while, at the same time, building on the individual's existing support network. C. Supports are the assistance provided to the individual to enable participation in the community. Supports are integral to each individual or family's quality of life and often enhance the lives of those involved. D. FISS may include, but are not limited to, supports involving: (1) Budgeting; (2) Medication administration; (3) Counseling; (4) Job coaching; (5) Helping an individual to access and complete the individual's education; (6) Participating in recreational and social activities; (7) Accessing community services; (8) Grocery shopping; (9) Respite, behavioral, and other services and supports needed by the family of the individual; and (10) Developing relationships. #### Regulation .04 Staffing and Training. *COMAR 10.22.06.04* A. The individual's plan determines the amount of staff time, pattern of supports, and type of staff training needed to support each individual or family. B. The licensee shall ensure that staff: (1) Have the necessary skills to carry out the individual's plan; and (2) Receive training in accordance with COMAR 10.22.02.11. #### Regulation .05 Setting and Location. *COMAR 10.22.06.05* A. The licensee shall provide FISS within the context of each individual or family's life style in the least intrusive manner possible. B. The licensee shall provide FISS consistent with each individual's IP. ### Chapter 07 — Vocational and Day Services Program Service Plan **Authority:** Health-General Article, §§7-903 and 7-904, Annotated Code of Maryland **Administrative History:** Effective date: October 20, 1986 (13:21 Md. R. 2321) **Administrative History:** Regulations .01 — 07, Fundamental Rights, repealed effective June 27, 1988 (15:13 Md. R. 1554) **Administrative History:** Regulations .01 — .07, Fundamental Rights of Individuals, adopted effective June 27, 1988 (15:13 Md. R. 1554) **Administrative History:** Chapter, Fundamental Rights of Individuals, repealed and new chapter, Vocational and Day Services Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148) #### Regulation .01 Additional Regulatory Compliance. *COMAR 10.22.07.01* In addition to this chapter, a person who provides vocational or day services to an individual shall comply with the following regulations of this subtitle: A. COMAR 10.22.01; B. COMAR 10.22.02, except COMAR 10.22.02.07; C. COMAR 10.22.03; D. COMAR 10.22.04; E. COMAR 10.22.05; and F. COMAR 10.22.10, when applicable. #### Regulation .02 Rationale. *COMAR 10.22.07.02* A. Individuals often need assistance to obtain and maintain work in the community. With supports, job skills are learned and behavior appropriate for the workplace is increased. Work in the community provides income, self-esteem, and personal value for the individual. B. Individuals seeking to obtain and maintain work in the community are free to choose preferred types of work, to seek change of work when not satisfied, and have their day activities reflect the needs, preferences, and desires stated in their IPs, including the ability to combine day or vocational services with other community activities, such as school or recreation. C. A licensee may not limit an individual to specific types of services because of their ages, severity of disability, or level of supports needed to work. D. A licensee shall use accommodation, coaching, individual choice, and preferences in matching individuals and employment opportunities. #### Regulation .03 Scope. *COMAR 10.22.07.03* A. The vocational or day services licensee shall respond to individual needs and preferences in accordance with the IP. B. Current program models include: (1) Supported employment; (2) Vocational services; (3) Day habilitation; and (4) Volunteer work. C. Supported Employment. (1) Supported employment includes: (a) Individuals who are self-employed and need supports, or are working in community businesses for pay with licensee funded supports; or (b) Any work program except one in an SRC that includes supports necessary for the individual to achieve the desired outcomes established in the IP. (2) A licensee shall provide job skill training which includes but is not limited to: (a) Skills required to perform a job; (b) Community mobility training; (c) Guidance in acceptable job behaviors; and (d) Job seeking and interviewing skills. (3) An individual typically works 20 — 40 hours per week, not including commuting time. D. Vocational Services. (1) Vocational services include but are not limited to: (a) Vocational assessment activities; (b) Job training, work skill training, and placement programs; (c) Training in social skills, acceptable work behaviors, and other skills such as money management; (d) Basic safety skills; (e) Training in work-related hygiene; and (f) Work skills. (2) A vocational services licensee shall provide services at a minimum: (a) 220 days per year; (b) 5 days a week; (c) 6 hours a day not including commuting time; or (d) Consistent with an alternative schedule approved by the Director. E. Day Habilitation. (1) Day habilitation includes individuals participating in structured activities designed to increase or maintain: (a) Motor skills; (b) Communication skills; (c) Personal hygiene skills; (d) Leisure skills; and (e) Community integration. (2) A licensee providing day habilitation shall provide services at a minimum: (a) 220 days per year; (b) 5 days a week; (c) 6 hours per day not including commuting time; or (d) Consistent with an alternative schedule approved by the Director. F. Volunteer Work. (1) Volunteer work enables the individual to gain desired work experience, personal satisfaction, and to contribute to the community. (2) The individual and the individual's team shall evaluate, at least annually, the appropriateness and continued desirability of the volunteer placement over paid work activities. G. Transportation Services. (1) The licensee is responsible for assisting or arranging transportation services with the individual. (2) The licensee shall use the mode of transportation which achieves the least costly, and most appropriate, means of transportation for the individual with priority given to the use of public transportation, when appropriate. (3) An individual who lives within walking distance of the program or worksite and who is sufficiently mobile shall be encouraged to walk. (4) The licensee shall keep accurate records which clearly indicate the transportation that the individual uses to participate in the vocational or day service including an alternative transportation plan if the primary plan is unavailable. #### Regulation .04 Staffing and Training. *COMAR 10.22.07.04* A. Staffing levels shall be determined by the IP with the licensee providing the staff for each individual as indicated in the IP. B. The licensee shall ensure that staff receive training in accordance with COMAR 10.22.02.11. #### Regulation .05 Setting and Location. *COMAR 10.22.07.05* A. Integrated work settings are preferred. B. A licensee providing services under this chapter shall make every effort to provide services that are integrated in neighborhoods and communities. ### Chapter 08 — Community Residential Services Program Service Plan **Authority:** Health-General Article, §§7-714, 7-903, and 7-904, Annotated Code of Maryland **Administrative History:** Effective date: July 26, 1999 (26:15 Md. R. 1148) #### Regulation .01 Additional Regulatory Compliance. *COMAR 10.22.08.01* In addition to this chapter, a person who provides residential services to an individual shall comply with the following regulations of this subtitle: A. COMAR 10.22.01; B. COMAR 10.22.02; C. COMAR 10.22.03; D. COMAR 10.22.04; E. COMAR 10.22.05; and F. COMAR 10.22.10, when applicable. #### Regulation .02 Rationale. *COMAR 10.22.08.02* A. Living in the community involves both a wide range of skills and choices about life style. B. Community residential models accommodate the wide range of choices individuals and their families make about how to live in the community. C. Community residential models are designed to give preference to small and individualized settings. D. Individuals with developmental disabilities have the same range of options about where to live in the community as are available to all people. E. The Administration respects personal choice regarding decisions about where and with whom individuals with developmental disabilities may live. #### Regulation .03 Scope. *COMAR 10.22.08.03* A. Current community residential service models include: (1) Alternative living units (ALU); (2) Group homes; (3) Individual family care homes (IFC); and (4) Community supported living arrangements (CSLA). B. A licensee shall make every effort to provide services to an individual according to the individual's choices as identified in the IP. C. The range of community residential service options available to an individual may be limited by resources or lack of available sites. D. For transportation services other than those outlined in COMAR 10.22.07.03G, a licensee shall provide or arrange for the provision of the use of transportation services. E. Respite Services. (1) A site may be licensed to accommodate additional individuals for respite services. (2) Respite services for an individual: (a) May not exceed 45 days within any 1-year period; (b) May not be provided for more than 28 consecutive days; (c) May not be provided unless the licensee is provided with current health, emergency, and any other information that is essential to the licensee's ability to provide appropriate care for the individual; and (d) May be provided for IFC care providers only to the extent permitted by the IFC care provider contract. F. A licensee providing respite services shall: (1) Ensure that the health and safety needs of the individual are met; and (2) Comply with COMAR 10.22.04 and 10.22.05 if the individual has an IP, and 10.22.10 if the individual has a behavior plan. #### Regulation .04 Staffing and Training. *COMAR 10.22.08.04* A. A licensee shall provide staffing levels and patterns as determined in the IP. B. A licensee shall provide or arrange for the provision of training in accordance with COMAR 10.22.02.11. #### Regulation .05 Setting and Location. *COMAR 10.22.08.05* A. An individual may receive services under this chapter in the individual's own home, in the family's home, in a current residential service model, or in any other service model approved by the Director in accordance with COMAR 10.22.02.09F. B. A licensee providing services under this chapter shall make every effort to provide services that are integrated in neighborhoods and communities. ### Chapter 09 — Resource Coordination Program Service Plan **Authority:** Health-General Article, §§7-903 and 7-904, Annotated Code of Maryland **Administrative History:** Effective date: August 25, 1986 (13:17 Md. R. 1922) **Administrative History:** Chapter, Services Coordination Programs for Mentally Retarded and Nonretarded Developmentally Disabled Individuals, repealed and new chapter, Resource Coordination Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .03D adopted effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .04A amended effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .05A amended effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .05D adopted effective May 5, 2008 (35:9 Md. R. 897) **Administrative History:** Regulation .06A amended effective May 5, 2008 (35:9 Md. R. 897) #### Regulation .01 Additional Regulatory Compliance. *COMAR 10.22.09.01* In addition to this chapter, a person who provides resource coordination to an individual shall comply with the following regulations of this subtitle: A. COMAR 10.22.01; B. COMAR 10.22.02, except COMAR 10.22.02.05, .06, .07, .11, .12, and .14E(1)(d); C. COMAR 10.22.03; D. COMAR 10.22.04; and E. COMAR 10.22.05. #### Regulation .02 Rationale. *COMAR 10.22.09.02* A. Resource coordination is provided by a resource coordinator. B. The resource coordinator assists individuals in obtaining the best quality and most appropriate services and supports within available resources. C. The resource coordinator is responsible to individuals and their families for providing assistance in implementing individual choice, addressing individual satisfaction, and assuring that an individual's needs and preferences are addressed. #### Regulation .03 Scope. *COMAR 10.22.09.03* A. Resource coordination may be provided to individuals determined eligible for services from the Administration, including individuals on the waiting list. B. Resource coordination may only be provided by licensees who do not provide direct services to individuals. C. The level and intensity of resource coordination may vary according to the individual's needs and desire for resource coordination. D. In the State residential center, a resource coordinator shall be provided for all individuals for the purpose of participating in the development of the written plan of habilitation. #### Regulation .04 Functions of the Resource Coordination Licensee. *COMAR 10.22.09.04* The resource coordination licensee shall carry out the following functions: A. Determine an individual's needs, preferences, desires, satisfaction, and the most integrated setting appropriate to meet the individual's needs; B. Assist the individual through planning in choosing goals and outcomes, the services needed to accomplish these goals and outcomes, and the establishment of realistic time frames for meeting these goals and outcomes; C. Broker services in consultation with the regional office to obtain generic services, services funded by the Administration, and natural supports; D. Advocate for the individual to assure that the individual's rights are protected and the individual's needs and preferences are considered; E. Monitor and act as a third-party advocate for implementation of the IP; and F. If requested by the Administration, provide utilization review of services being provided to individuals. #### Regulation .05 Responsibilities of the Resource Coordinator. *COMAR 10.22.09.05* A. The resource coordinator is responsible for: (1) Ensuring that each individual receives an IP that is designed to meet the individual's needs, preferences, desires, goals, and outcomes in the most integrated setting appropriate to meet the individual's needs and in the most cost effective manner; (2) Documenting that the IP is being implemented as designed; (3) Communicating information with the Administration in an effort to achieve a responsive service delivery system; (4) Assisting the individual in applying for services; and (5) Providing education to individuals and their families concerning: (a) The range of most integrated setting service and support options that may be appropriate to meet the individual's needs; (b) How to access services, and (c) How to coordinate and advocate for services. B. Resource coordinators shall have personal knowledge of each individual served and make every effort to effectively accommodate the individual's needs and preferences. C. Resource coordinators shall personally meet with each individual served, at least every 6 months, in an effort to effectively meet the individual's needs and preferences. D. In the State residential center, the resource coordinator shall: (1) Ensure that communication devices and techniques, including the use of sign language, as appropriate, are used to facilitate the involvement of the individual in the development of the written plan of habilitation; (2) Recommend the most integrated setting appropriate to meet the individual's needs; and (3) Conduct an annual update on the status and progress toward addressing and resolving the barriers to receiving services and supports in the most integrated setting. #### Regulation .06 Staffing and Training. *COMAR 10.22.09.06* A. A resource coordinator shall have the skills necessary to: (1) Determine the most integrated setting appropriate to meet the individual's needs; (2) Coordinate planning meetings; (3) Negotiate and resolve conflicts; (4) Assist individuals in gaining access to services and supports; (5) Coordinate services; and (6) Monitor the provision of services to individuals. B. The resource coordination licensee shall ensure through appropriate documentation that the resource coordinator receives training in: (1) Fundamental rights; (2) Communication skills; (3) Specific disabilities of the individuals the resource coordinator serves; (4) Development of the IP; (5) Facilitating individual choice; (6) Determining individual satisfaction; and (7) Developing opportunities for individuals to establish relationships, friendships, and connections in the community. #### Regulation .07 Setting. *COMAR 10.22.09.07* To the extent feasible, individuals may select: A. Their own resource coordinator; and B. The time, place, and frequency of meetings. ### Chapter 10 — Behavior Support Services Program Service Plan **Authority:** Health-General Article, §§7-904; Health Occupations Article, §17-6A-01 et seq.; Annotated Code of Maryland **Administrative History:** Effective date: July 29, 1985 (12:15 Md. R. 1517) **Administrative History:** Regulations .01 — .10 repealed effective January 23, 1989 (16:1 Md. R. 70) **Administrative History:** Regulations .01 — .11 adopted effective January 23, 1989 (16:1 Md. R. 70) **Administrative History:** Regulation .09B amended as an emergency provision effective May 3, 1989 (16:10 Md. R. 1102); adopted permanently effective October 30, 1989 (16:21 Md. R. 2261) **Administrative History:** Regulation .09G amended effective January 6, 1992 (18:26 Md. R. 2830) **Administrative History:** Chapter, Intensive Behavior Management and Other Programs Utilizing Behavior Management Techniques, repealed and new chapter, Behavior Support Services Program Service Plan, adopted effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .05B amended effective January 30, 2017 (44:2 Md. R. 85) #### Regulation .01 Additional Regulatory Compliance. *COMAR 10.22.10.01* In addition to this chapter, a person who provides behavior support services to an individual shall comply with the following regulations of this subtitle: A. COMAR 10.22.01; B. COMAR 10.22.02; C. COMAR 10.22.03; D. COMAR 10.22.04; and E. COMAR 10.22.05. #### Regulation .02 Rationale. *COMAR 10.22.10.02* A. The Administration serves individuals who exhibit challenging behaviors and require a variety of supports to achieve success in exercising the individual's choices responsibly. B. Behavior support services are designed to assist individuals who exhibit challenging behaviors in acquiring skills, gaining social acceptance, and becoming full participants in the community. #### Regulation .03 Scope. *COMAR 10.22.10.03* A. A licensee who provides services to an individual in the community or in an SRC whose record indicates a need for a behavior plan shall meet the requirements of this chapter. B. A licensee who contracts for behavior support services shall ensure that its contractor meets the requirements of this chapter and is knowledgeable about the Administration's service delivery system. C. Behavior support services include: (1) Behavioral consultation; (2) Temporary augmentation of staff; (3) Behavioral training; and (4) Behavioral respite services. #### Regulation .04 Staffing and Training. *COMAR 10.22.10.04* In addition to the training requirements in COMAR 10.22.02.11A — D, the licensee shall ensure that staff who provide behavior support services, before being assigned independent duties, receive training in the: A. Principles of behavioral change; and B. Appropriate methods of preventing or managing challenging behaviors, which may include the use of mechanical restraints. #### Regulation .05 Behavior Plan (BP). *COMAR 10.22.10.05* A. A licensee shall ensure that a BP is developed for each individual for whom it is required. B. The licensee shall ensure the BP: (1) Is developed, in conjunction with the team, by a licensed psychologist, psychology associate under the supervision of a licensed psychologist, licensed behavior analyst, licensed physician, licensed certified social worker, or licensed or certified professional counselor, who shall have training and experience in applied behavior analysis; (2) Is based on and includes a functional analysis or assessment of each challenging behavior as identified in the IP; (3) Specifies the behavioral objectives for the individual, and includes: (a) A description of the hypothesized function of current behaviors including their frequency and severity; and (b) Criteria for determining achievement of the objectives established; (4) Takes into account the medical condition of the individual; (5) Describes the treatment techniques and when the techniques are to be used; (6) Specifies the emergency procedures to be implemented for the individual with a history of exhibiting behaviors that present a danger to self or serious bodily harm to others; (7) Includes a description of the adaptive skills to be learned by the individual that serve as functional alternatives to the challenging behavior or behaviors to be decreased; (8) Identifies the person or persons responsible for monitoring the BP; (9) Specifies the data to be collected to assess progress towards meeting the BP's objectives; and (10) Describes and documents each use of mechanical and physical restraint, the reason for its use, and the length of time used. C. Before implementation, the licensee shall ensure that each behavior plan which includes the use of restrictive techniques is: (1) Approved by the standing committee as specified in COMAR 10.22.02.14E(1)(d); and (2) Includes written informed consent of the: (a) Individual; (b) Individual's legal guardian; or (c) Surrogate decision maker as defined n Health-General Article, §5-605, Annotated Code of Maryland. D. Before a licensee discontinues a behavior plan, the team and an individual appropriately licensed under Health Occupations Article with training and experience in applied behavior analysis shall recommend that the individual no longer needs a behavior plan. #### Regulation .06 Use of Restrictive Techniques. *COMAR 10.22.10.06* A. The licensee shall ensure that the use of restrictive techniques in any BP: (1) Represents the least restrictive, effective alternative, or the lowest effective dose of a medication; and (2) Is only implemented after other methods have been: (a) Systematically tried, and (b) Objectively determined to be ineffective. B. The licensee shall collect and present objective data to the authorizing licensed health care practitioner to indicate whether the restrictive technique being used is effective in reducing the individual's challenging behavior. C. The licensee shall: (1) Convene the team within 5 calendar days after an emergency use of a restrictive technique to review the situation and action taken; (2) Determine subsequent action include whether the development or modification of a BP is necessary; and (3) Document that the requirements of this regulation have been met. D. The licensee shall ensure that staff do not use: (1) Any method or technique prohibited by law, including aversive techniques; (2) Any method or technique which deprives an individual of any basic right specified in Health-General Article, §§7-1002—7-1004, Annotated Code of Maryland, except as permitted in COMAR 10.22.04.03A; (3) Seclusion; (4) A room from which egress is prevented; or (5) A program which results in a nutritionally inadequate diet. E. Staff may not use a restrictive technique: (1) As a substitute for a treatment plan; (2) As punishment; or (3) For convenience. #### Regulation .07 Use of Medications to Modify Challenging Behavior. *COMAR 10.22.10.07* A. In addition to the requirements in Regulations .05 and .06 of this chapter, the licensee shall ensure that a BP which includes the use of medication includes: (1) The specific medications that have been prescribed; (2) The rationale for prescribing each medication; (3) Any alternate methods of management being used to bring challenging behavior under control; and (4) Objective data collected by staff and presented to the licensed health care practitioner to indicate that the medication being used is effective in reducing the individual's challenging behavior. B. The licensee shall ensure that a licensed health care practitioner documents that: (1) Any potential side effect from the medication outweighs the behavior that will occur without the use of the medication; and (2) Attempts are being made to gradually decrease the dosage or discontinue the medication when clinically indicated. C. A licensed health care practitioner shall review any medication that has been prescribed to modify behavior at a minimum of every 90 days. D. PRN orders for medications to modify behavior are prohibited. E. Medications to modify behavior may not be used in quantities that interfere with an individual's ability to participate in daily living activities. #### Regulation .08 Use of Physical Restraint. *COMAR 10.22.10.08* A. Physical restraint may only be used when the individual's behavior presents a danger to self or serious bodily harm to others. B. The licensee shall ensure that only staff who have been trained in the management of disruptive behavior, or other curriculum approved by the Administration, may use a physical restraint and may only do so as specified in the curriculum. C. In addition to the requirements in Regulation .06 of this chapter, the licensee shall document in the individual's record each use of a physical restraint, including the reason for its use. #### Regulation .09 Use of Mechanical Restraint and Support. *COMAR 10.22.10.09* A. Use of Mechanical Restraint for Behavioral Purposes. (1) A mechanical restraint may only be used: (a) To prevent an individual from engaging in self-injurious behaviors such as head banging, teeth gnashing, and similar behavior; (b) To prevent serious bodily harm to others; or (c) As required by an individual's treating licensed health care practitioner to allow an individual to recuperate from surgery or injury. (2) The licensee shall ensure that a mechanical restraint is designed and used: (a) In a humane, safe, and effective manner; and (b) Without intent to harm or create undue discomfort. (3) If a mechanical restraint is being used for the purpose of §A(1)(a) and (b) of this regulation, the licensee shall: (a) Meet the requirements in Regulations .05 and 06 of this chapter; (b) Obtain written authorization from a licensed health care practitioner trained in applied behavior analysis for the use of the mechanical restraint, including the duration of its use and the circumstances under which the restraint is authorized; (c) Document in the individual's record each use of mechanical restraint, including the reason for its use; and (d) Require staff to check on the individual every 15 minutes. (4) When a mechanical restraint is being used for the purpose of §A(1)(a) and (b) of this regulation, the licensee shall afford the individual the opportunity: (a) To be escorted to the bathroom and offered fluids at least every 2 hours; (b) For motion and exercise for a period of not less than 10 minutes during each 2 hours in which the restraint is used; and (c) To be provided meals at regularly scheduled hours. (5) A licensed health care practitioner who authorized the use of the mechanical restraint shall review the authorization at a minimum of every 90 days, and document its effectiveness and whether continuation is indicated. B. Use of Mechanical Restraint for Medical Purposes. If a mechanical restraint is being used for the purpose of §A(1)(c) of this regulation, the licensee shall: (1) Obtain written authorization from the individual's treating licensed health care practitioner; and (2) Document in the individual's record the reason and guidelines for the use of the restraint, including the time frame the mechanical restraint is to be used. C. Use of a Mechanical Support. (1) A mechanical support may only be used if authorized by a licensed health care practitioner. (2) The licensee shall ensure that a mechanical support is designed and used: (a) In a humane, safe, and effective manner; and (b) Without intent to harm or create undue discomfort. (3) The licensee shall document in the individual's record the reason for use of the mechanical support, when it is to be used, and the directions for its use. (4) The licensed health care practitioner who authorized the use of the mechanical support shall document its effectiveness and whether continuation is indicated, at least, on an annual basis. #### Regulation .10 Use of Chemical Restraint. *COMAR 10.22.10.10* A. Chemical restraint may only be used when the individual's behavior presents a danger to self or serious bodily harm to others. B. A licensee may only use a chemical restraint in a behavioral emergency when: (1) Ordered by a licensed health care practitioner; and (2) Administered and monitored by a licensed health care practitioner. C. In addition to the requirements in Regulation .06 of this chapter, the licensee shall document in the individual's record the use of any chemical restraint, including the reason for its use. #### Regulation .11 Monitoring Use of Medications to Modify Behavior and Restrictive Techniques. *COMAR 10.22.10.11* The licensee shall monitor the use of restrictive techniques through its internal quality assurance process as required by COMAR 10.22.02.14B(4). #### Regulation .12 IBMP — Alternative Living Arrangements. *COMAR 10.22.10.12* After the effective date of this chapter, a licensee providing residential services which specializes in behavior support services shall comply with the requirements of this chapter and COMAR 10.22.08. ### Chapter 11 — Respite Services in the State Residential Center (SRC) **Authority:** Health-General Article, §7-509, Annotated Code of Maryland **Administrative History:** Effective date: June 17, 1985 (12:12 Md. R. 1164) **Administrative History:** Regulations .01 — .10, Developmental Services, repealed effective March 23, 1987 (14:6 Md. R. 716) **Administrative History:** Regulations .01 — .19, Community Supported Living Arrangements (CSLA) Program, adopted as an emergency provision effective October 8, 1991 (18:22 Md. R. 2392); adopted permanently effective March 10, 1992 (19:3 Md. R. 304) **Administrative History:** Regulation .02B amended as an emergency provision effective June 14, 1996 (23:14 Md. R. 1006); amended permanently effective December 2, 1996 (23:24 Md. R. 1681) **Administrative History:** Chapter, Community Supported Living Arrangements (CSLA) Program, repealed and new chapter, Respite Services in the State Residential Center (SRC), adopted effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .04B amended effective November 25, 2013 (40:23 Md. R. 1934) **Administrative History:** Regulation .06B amended effective November 25, 2013 (40:23 Md. R. 1934) #### Regulation .01 Additional Regulatory Compliance. *COMAR 10.22.11.01* In addition to this chapter, an SRC providing respite services shall comply with the following regulations of this subtitle: A. COMAR 10.22.01; B. COMAR 10.22.04; C. COMAR 10.22.05; and D. COMAR 10.22.10. #### Regulation .02 Purpose. *COMAR 10.22.11.02* This chapter addresses the provision of respite services in the SRC for individuals currently living in the community. #### Regulation .03 Provision of Services. *COMAR 10.22.11.03* Before respite services are utilized in the SRC, all efforts are made by the Administration to provide individuals living in the community with respite services in the community. Only when there are no other appropriate alternatives available are respite services provided in the SRC. #### Regulation .04 Eligibility. *COMAR 10.22.11.04* To be eligible to receive respite care in the SRC, the individual: A. Shall be eligible to receive services funded by the Administration; B. Shall have an appropriate evaluation with the diagnosis of an intellectual disability; C. Shall have needs that are able to be met effectively while at the SRC; and D. May not be in receipt of full residential services in a community program, except with the approval of the Director. #### Regulation .05 Length of Stay. *COMAR 10.22.11.05* Respite services in the SRC may only be provided to an individual for not more than: A. 45 days per calendar year; or B. 28 consecutive days. #### Regulation .06 Procedures for Respite Requests. *COMAR 10.22.11.06* A. The individual's proponent or licensee shall direct requests for respite services to the appropriate regional office. B. The regional office shall arrange for the following: (1) The completion of a formal application; (2) The collection of information to substantiate a diagnosis of an intellectual disability; and (3) A meeting with the individual, proponent, or the licensee to discuss the terms and conditions of respite services. C. The proponent or licensee shall complete all forms required for respite services. D. The regional office shall render a written decision to the proponent or licensee within a week of the receipt of the completed application. E. On entering, the SRC shall arrange for a medical examination or nursing assessment as is appropriate to the individual. F. The SRC shall enter into a contract with the proponent or licensee which at a minimum contains: (1) A statement that the acceptance of an individual for respite services is not considered an admission as defined in Health-General Article, §7-101(c), Annotated Code of Maryland; (2) A mutually agreed upon date on which the SRC may not provide respite services; and (3) A designated time for the licensee or proponent to return the individual to the individual's community residence. #### Regulation .07 Procedures for Leaving Respite Services. *COMAR 10.22.11.07* A. The SRC shall arrange for a medical examination or nursing assessment as is appropriate to the individual at the time the individual leaves respite services and shall document the findings. B. The SRC shall document information about the individual's response to respite services. C. The proponent or licensee shall return the individual to the individual's community residence at the time agreed to on the admission document. #### Regulation .08 Daily Programs. *COMAR 10.22.11.08* A. The SRC shall provide appropriate daily activities during the time the individual is in respite services. B. The SRC shall make every attempt to maintain the individual in the individual's vocational or day activity during the period of respite services and document the reasons if the individual is unable to attend. #### Regulation .09 Individual Records. *COMAR 10.22.11.09* The SRC shall maintain a complete record for each individual receiving respite services. #### Regulation .10 Funding. *COMAR 10.22.11.10* The Department's Division of Reimbursement shall determine the cost of respite services in the SRC pursuant to Health-General Article, §16-201, Annotated Code of Maryland. ### Chapter 12 — Eligibility for and Access to Community Services for Individuals with Developmental Disability **Authority:** Health-General Article, §7-401, Annotated Code of Maryland **Administrative History:** Effective date: March 4, 1991 (18:4 Md. R. 447) **Administrative History:** Regulation .03B amended effective September 28, 1992 (19:19 Md. R. 1708) **Administrative History:** Regulations .03B and .12A amended as an emergency provision effective June 14, 1996 (23:14 Md. R. 1006); amended permanently effective December 2, 1996 (23:24 Md. R. 1681) **Administrative History:** Regulation .07 amended effective September 28, 1992 (19:19 Md. R. 1708) **Administrative History:** Regulation .12A amended effective September 28, 1992 (19:19 Md. R. 1708) **Administrative History:** COMAR 10.22.18 recodified to COMAR 10.22.12 effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .02B amended effective November 25, 2013 (40:23 Md. R. 1934) **Administrative History:** Regulation .03B amended effective March 26, 2007 (34:6 Md. R. 627); November 25, 2013 (40:23 Md. R. 1934), March 30, 2026 (53:6 Md. R. 291) **Administrative History:** Regulation .05B amended effective March 30, 2026 (53:6 Md. R. 291) **Administrative History:** Regulation .07B amended effective November 25, 2013 (40:23 Md. R. 1934); March 30, 2026 (53:6 Md. R. 291) **Administrative History:** Regulation .08B amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845) **Administrative History:** Regulation .11A amended as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); amended permanently effective December 22, 2003 (30:25 Md. R. 1845) **Administrative History:** Regulation .11F adopted as an emergency provision effective September 1, 2003 (30:20 Md. R. 1445); adopted permanently effective December 22, 2003 (30:25 Md. R. 1845) #### Regulation .01 Purpose. *COMAR 10.22.12.01* A. These regulations specify the individuals with developmental disability who are eligible for Developmental Disabilities Administration (DDA) funded services, the eligibility criteria which are set forth in Health-General Article, Title 7, Annotated Code of Maryland, and the process of eligibility determination. B. These regulations delineate the eligibility and access determination process involved in obtaining funding for services from the Developmental Disabilities Administration. C. By outlining the eligibility and access process, these regulations comply with the requirements of Health-General Article, Title 7, Subtitle 4. They establish a uniformly applied Statewide policy that recognizes the needs of families and the comparative urgency of these needs. #### Regulation .02 Scope. *COMAR 10.22.12.02* A. This chapter is applicable to the eligibility and access process for individuals with developmental disability involved in seeking funding from the Developmental Disabilities Administration for services provided in community programs under the jurisdiction of the Administration. They do not apply to those similar processes which are related to services provided in State residential centers (SRCs) that are operated by the DDA. B. This chapter is not intended to address the criteria for access to specific services funded by the DDA. COMAR 10.22.13 addresses the admission of individuals with intellectual disabilities to State residential centers under the jurisdiction of the Developmental Disabilities Administration. C. Individuals committed to the Department through the Maryland court system are not subject to the procedures set forth in these regulations. #### Regulation .03 Definitions. *COMAR 10.22.12.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Developmental Disabilities Administration (DDA). (2) “Alternative living unit (ALU)” means a residence that: (a) Provides residential services for individuals who, because of developmental disability, require specialized living arrangements; (b) Admits not more than three individuals; and (c) Provides 10 or more hours of supervision per unit, per week. (3) “Applicant” means the individual who files an application for services with the DDA. (4) “Application for services” means the instrument: (a) Used to make preliminary determination of eligibility for DDA services, the nature of the disability, the services required, and how these services are to be provided; (b) Providing the basis for preliminary determination of service priority. (5) “Appropriate evaluation” means the assessment of an individual using accepted professional standards to document the presence of a: (a) Developmental disability as defined in Health-General Article, §7-101, Annotated Code of Maryland; or (b) Disability that qualifies the individual for individual support services only as defined in Health-General Article, §7-403(c), Annotated Code of Maryland. (6) “Caregiver” means the person who is primarily responsible for the ongoing care of the individual who is applying for services from the DDA. If the applicant is the caregiver, this term is applicable to the applicant. (6-1) “Community Supported Living Arrangements Services (CSLA)” means one or more of the following services to assist an individual with developmental disability or an individual eligible for support services only in those nonvocational activities necessary to enable that individual to live in the individual's own home, apartment, family home, or rental unit, with not more than two other recipients of these services: (a) Personal assistance; (b) Supports that enhance the individual's opportunities for community participation and to exercise choice and control over the individual's own life; (c) Community integration training services necessary to assist the individual in achieving and maintaining increased integration, interdependence, and productivity; (d) 24-hour emergency assistance; (e) Assistive technology; (f) Adaptive equipment; (g) Case management services; (h) Environmental modification; (i) Respite care; and (j) Other services as approved by the Secretary or the Secretary's designee. (7) “Department” means the Maryland Department of Health. (8) “Developmental Disabilities Administration access unit” (“DDA access unit” or “unit”) means the component which is under contract with the DDA to conduct the preliminary assessment of eligibility and priority for services based on the information provided on the application. (9) “Developmental disability” means a severe, chronic disability of an individual that: (a) Is attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; (b) Is manifested before the individual becomes 22 years old; (c) Is likely to continue indefinitely; (d) Results in an inability to live independently without external support or continuing and regular assistance; and (e) Reflects the need for a combination and sequence of special, interdisciplinary, or generic care, treatment, or other services that are individually planned and coordinated for the individual. (10) “Director” means the Director of the Developmental Disabilities Administration. (11) “Eligibility for support services only” means an individual shall have a severe chronic disability that is: (a) Attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; and (b) Likely to continue indefinitely. (12) “Family support services” means a program designed to enable a family to provide for the needs of a child with developmental disability living in the home. Family support services include: (a) Individual and family counseling; (b) Personal care; (c) Day care; (d) Specialized equipment; (e) Health services; (f) Respite care; (g) Housing adaptations; (h) Transportation; and (i) Other necessary services. (13) “Grabau class” means those individuals: (a) Who are confined in a SRC; (b) Whose level of intellectual and personal skills is sufficient to allow them to function outside the SRC; (c) Who have been characterized by the SRC as having maladaptive behavior or emotional disturbance of sufficient severity as to require their continued placement with the SRC; and (d) Who have been confirmed as members of the class through an appropriate evaluation and staffing process designated by the DDA. (14) “Home and Community Based Waiver (waiver)” means the document and any amendments to it submitted by the single State agency for Title XIX and approved by the Secretary of Health and Human Services, which authorizes the waiver of statutory requirements limiting coverage for home and community based services under the Medicaid State Plan. (15) “Individual” means the person for whom an application for services has been filed with the DDA. (16) “Individual family care home (IFC)” means a private single family residence licensed by the Department under COMAR 10.22.08 which: (a) Under supervision, provides a home for individuals with developmental disability in a family atmosphere; and (b) Provides habilitation services for one to three individuals who are not related to the caregiver. (17) Individual Support Services. (a) “Individual support services” means an array of services that are designed to increase or maintain an individual's ability to live alone or in a family setting. (b) “Individual support services” includes: (i) In-home assistance with meals and personal care; (ii) Counseling; (iii) Physical, occupational, or other therapies; (iv) Architectural modification; and (v) Any other services that the Administration considers appropriate to meet the individual's needs. (18) “Knott class” means individuals with intellectual disabilities who were or are deemed inappropriately placed within the Department’s operated behavioral health facilities. (19) “Local review committee (LRC)” means the committee established by the regional director to review the service needs of eligible persons and make recommendations to the regional director. (20) “Low intensity support services” means support services in accordance with COMAR 10.22.06. Services qualifying for this category are: (a) Designed to be one-time only; (b) Low cost with a cap of $3,000 per individual per year; or (c) Approved by the regional office only if the cost of the services exceeds $3,000 or the services are needed beyond 1 calendar year. (21) “Personal contact” means a discussion of circumstances with the applicant, caregiver, or other proponent, when one exists, with a representative of the DDA, who has knowledge in the disability or has access to the assistance of someone with knowledge in the disability, for the purpose of gathering information relevant to the determination of eligibility, service needs, and priorities. (22) “Preliminary determination” means the outcome of the review of information supplied by or for the individual applying for DDA-funded services to produce an initial assessment of eligibility, service needs, and priorities. (23) “Program” means a prescribed set of services and activities designed to achieve specific objectives related to the needs of the individuals served. (24) “Proponent” means any person or agency who has a legitimate interest in the welfare of the individual applying for DDA services or being served in a DDA-licensed, operated, or funded program. (25) “Provider” means a licensed agency which provides services through an appropriate agreement with the Department. (26) “Regional director” means the director's designee who is charged with the management of the service delivery system in a specific geographic area of the State. (27) “Resident” means an individual who: (a) Demonstrates that that individual is living in the State voluntarily with an intent to remain on a permanent basis, including children with parents or guardians who reside out of the State; (b) Resides out-of-State but whose parents or guardians are residents of Maryland; or (c) Is a migrant worker and, while in the State, needs medical care and is not receiving assistance from any other state or political jurisdiction. (28) “Secretary” means the Secretary of Health. (29) “Secretary's designee” means the Director of the Developmental Disabilities Administration. (30) “Service coordinator” means a professional who is assigned the responsibility for assisting the consumer in accessing the service delivery system more efficiently and effectively. This assistance is effected through planning, monitoring, and coordinating the medical, social, habilitative, and vocational services necessary to meet the identified needs of the consumer, as agreed upon and specified in the consumer's individualized service plan. (31) “State residential center (SRC)” means a place that: (a) Is owned and operated by the State; (b) Provides residential services for individuals with intellectual disabilities and who, because of intellectual disabilities, require specialized living arrangements; and (c) Admits nine or more individuals with intellectual disabilities. (32) “Waiting list” means, for the purpose of this chapter, those individuals considered eligible for services and who have not received those services under the auspices of these regulations. #### Regulation .04 Accessing the DDA Service Delivery System by Individuals with Developmental Disability. *COMAR 10.22.12.04* A. Referrals. (1) An individual may be referred for service or services funded by the DDA by anyone who has legitimate interest in the welfare of the individual. (2) Individuals shall make referrals to and obtain applications from the DDA or its designee. (3) Individuals making referrals on behalf of individuals purported to have a developmental disability shall make them either separately or together with an application for services. B. Application for Services. (1) An individual applying for services funded wholly or in part by the DDA shall complete, or with assistance given by the DDA or its designee shall complete, an application for services. (2) An application may be submitted by: (a) The individual, if an adult; or (b) A parent, guardian, caregiver, or other proponent, when one exists. (3) The individual submitting the application shall provide, at a minimum, sufficient information to make a preliminary determination of: (a) The nature of the disability; (b) Eligibility for DDA-funded services based on the characteristics of the individual; (c) The individual's priority for DDA-funded services which shall take into account the: (i) Urgency of need, (ii) Strengths and needs of the applicant and caregiver, (iii) Environment in which the applicant lives; (d) Service or services needed; (e) Type of environment in which any needed services could be provided with the least restriction on the liberty of the individual; and (f) Further evaluation, if any, the individual may require. C. Processing the Application. (1) The individual shall complete the application and send it to the DDA access unit. (2) The unit shall send the applicant, caregiver, or other proponent, when one exists, a letter indicating receipt of the application and the results of the preliminary determination within 7 calendar days from the date the application is received. #### Regulation .05 Eligibility Criteria and Preliminary Determination Process. *COMAR 10.22.12.05* A. Eligibility Criteria. To be eligible for services funded by the DDA as an individual with developmental disability, that individual shall: (1) Be a resident of Maryland; and (2) Have an evaluation that finds that a developmental disability is present. B. Preliminary Determination Process. (1) The DDA access unit shall complete the preliminary determination and send the applicant, caregiver, or other proponent, when one exists, a letter containing the results within 7 calendar days of receipt of the application as indicated in Regulation .04C(2),of this chapter. (2) The preliminary determination consists of a review of all information supplied by or for the individual to determine the presence of an apparent disability which meets the eligibility requirements. (3) The DDA access unit shall send a letter to the applicant, caregiver, or other proponent, when one exists, which contains the following information: (a) The DDA access unit has received the application; (b) The individual appears to have a developmental disability, or does not appear to have a developmental disability, but may be eligible for individual support services in accordance with Health-General Article, §7-403(c), Annotated Code of Maryland; (c) The applicant, caregiver, or other proponent, when one exists, shall receive a personal contact in accordance with Regulation .03B(21) of this chapter, or the individual is not eligible for services funded by the DDA and no further action shall be taken by the DDA, absent an appeal of this determination; (d) The individual may be eligible for services from the Behavioral Health Administration; and (e) The individual has the right to an informal hearing to appeal the decision in accordance with COMAR 10.22.16. #### Regulation .06 Eligibility Determination Process — Personal Contact and Determination of Service Needs. *COMAR 10.22.12.06* A. Determination of Service Needs. (1) When a personal contact is made by a representative of the DDA, in accordance with Regulation .05B(3)(c), of this chapter, the representative shall: (a) Establish if the individual has a developmental disability; (b) Establish the nature of the disability; (c) Collect sufficient information, including any existing evaluations, to make a recommendation concerning assignment to a services priority category, taking into account the strengths and needs of the family, caregiver, and the individual; (d) Describe the nature of the services that the individual may require through: (i) Discussion with the applicant, caregiver, or other proponent, when one exists, and (ii) Observation of the interaction between the applicant, caregiver, or other proponent, when one exists; (e) Describe the type of environment that the individual may require through: (i) Discussion with the applicant, caregiver, or other proponent, when one exists, and (ii) Observation of the interaction between the applicant, caregiver, or other proponent, when one exists. (2) A face-to-face personal contact shall be conducted for individuals living in the community. For individuals living in chronic hospitals, rehabilitation facilities, residential schools, or for a transitioning youth whose only service need is a day program, a personal contact may consist of interviews with staff or individuals by phone or in person. Knott class individuals shall receive a personal contact. Individuals with the sole diagnosis of mental illness or otherwise not eligible for DDA-funded services may not receive a personal contact. (3) A representative of the DDA shall give written results of the personal contact to the appropriate regional director with a recommendation regarding eligibility, service needs, and priorities. (4) If the regional director agrees that the individual is eligible for services, the regional director shall recommend to the Director that the individual be assigned to one or more of six service priority categories described in Regulation .07B of this chapter, for each service as appropriate. (5) The Director shall review the recommendation of the regional director concerning eligibility, service needs, and priorities. (6) The Director shall send a letter to the applicant notifying the individual of the decision regarding the applicant's: (a) Eligibility; (b) Service needs; (c) Priorities; and (d) Right to an informal hearing in accordance with COMAR 10.22.16. B. Eligibility and Access Time Frame. (1) The entire eligibility and access process may not exceed 60 days except under the following conditions: (a) Scheduled appointments are cancelled by the applicant, caregiver, or other proponent, when one exists, and new appointments cannot be scheduled in a timely manner; or (b) Requested information necessary to make recommendations regarding eligibility, service needs, and priorities has not been received from the applicant, caregiver, or other proponent, when one exists. (2) The regional director shall review the applicant's requests for extensions of the eligibility and access process. Requests may be approved if the above conditions have been corrected or if definite arrangements have been made to correct the above conditions. #### Regulation .07 Eligibility Determination Process — Determination of Service Priority Category and Description of Categories. *COMAR 10.22.12.07* A. Determination of Service Priority Category. (1) The regional director shall base the recommendation regarding service priority on the determination that the individual meets the criteria for one or more of the following categories, which are listed in the order of priority in which applicants shall receive services: (a) Category I — Crisis Resolution; (b) Category II — Crisis Prevention; and (c) Category III — Current Request. (2) Individuals shall be served according to their priority ranking as follows: (a) Individuals in Category I are to be served before those in Category II; and (b) Individuals in Category II are to be served before those in Category III. (3) Service delivery is dependent upon levels of funding allocated for the fiscal year for the following discrete categories: (a) Category IV — Transitioning Youth; (b) Category V — Knott Class Member; (c) Category VI — Inappropriate Institutionalization; and (d) Category VII — Innovation or Demonstration Projects. (4) Individuals may be in more than one priority category at the same time. For example, an individual in the transitioning youth priority category for a day program may also be in the crisis prevention priority category for a residential program if the individual is graduating or leaving a secondary school program and has no place to live after that program ends. B. Description of Categories. (1) Category I — Crisis Resolution. (a) To qualify for this category, the applicant shall meet one or more of the following criteria. The applicant shall be: (i) Homeless or living in temporary housing with clear time-limited ability to continue to live in this setting with no viable non-DDA-funded alternative; (ii) At serious risk of physical harm in the current environment; (iii) At serious risk of causing physical harm to others in the current environment; (iv) In danger of losing DDA-funded residential services because of a lack of current day services; (v) One who has lost DDA-funded day services; or (vi) Living with a caregiver who is unable to provide adequate care due to the caregiver's impaired health, which may place the applicant at risk of serious physical harm. (b) To qualify for Category I under §B(1)(a)(ii), of this regulation, evidence such as the following shall be necessary. The applicant: (i) Has recently received severe injuries due to the behavior of others in the home or community; (ii) Has recently been the victim of sexual abuse; (iii) Has been neglected to the extent that the individual is at serious risk of sustaining injuries which are life threatening or which substantially impair functioning; (iv) Engages in self-injurious behavior which puts the individual at serious risk of sustaining injuries which are life threatening or which substantially impair functioning; or (v) Is at serious risk of sustaining injuries which are life threatening or which substantially impair functioning due to the physical surroundings. (c) If the applicant qualifies for Category I under §B(1)(a)(v), of this regulation, the individual shall qualify for day services only. (d) If the applicant is living in a situation where the applicant is the caregiver, §B(1)(a)(vi), of this regulation, shall apply to the applicant. (e) Individuals who qualify for services under this category shall, at a minimum, remain in this category until they have been provided with those services required to resolve the situation. (f) Individuals become eligible to receive services as the need occurs. (2) Category II — Crisis Prevention. (a) To qualify for this priority category, the applicant: (i) Shall have been determined by the DDA to have an urgent need for services; (ii) May not qualify for services based on the criteria for Category I; and (iii) Shall be at substantial risk for meeting one or more of the criteria in §B(1)(a) of this regulation, within 1 year, or have a caregiver who is 65 years old or more. (b) Individuals who qualify for services under this category shall, at a minimum, remain in this category until they have been provided with those services required to resolve the situation. (c) Individuals become eligible to receive services from the date of approval of priority status, except when eligibility is determined by the age of the caregiver. In this case, priority is determined by the caregiver's date of birth so that individuals with caregivers born at an earlier date have priority over individuals with caregivers born at a later date. (3) Category III — Current Request. (a) To qualify for this priority category, the applicant shall indicate at least a current need for services. (b) Prioritization of Services. (i) Applicants shall be prioritized for services based on the number of fiscal years they have been on the waiting list, except as provided for in §B(3)(b)(iv) of this regulation. (ii) Applicants on the waiting list for the longest period of time shall receive services before those who have been on the list for fewer years, except as provided for in §B(3)(b)(iv) of this regulation. (iii) Applicants whose applications are received by the DDA access unit within a given fiscal year shall be ranked by the fiscal year of application, and the month and day of birth. Those applicants born at the beginning of the fiscal year have priority over those born later in the year. (iv) For day programs only, the period of time that shall be counted toward prioritizing an individual shall begin with the year of departure from school or the year of application, whichever is later. (4) Category IV — Transitioning Youth. (a) To qualify for funding for services in this priority category the applicant shall be eligible: (i) For DDA-funded services in this category from the individual's 21st to the individual's 22nd birthday. If the date of graduation is after the individual's 21st birthday, the individual shall continue to be eligible for 1 year after the date of graduation. (ii) To receive day services only. (b) Individuals in this priority category shall also be in one or more of the other priority categories. (c) Individuals become eligible to receive services from the date of approval of priority status. (5) Category V — Knott Class. (a) To qualify for this priority category, the applicant shall have: (i) An intellectual disability; and (ii) Been determined inappropriately retained in a Department operated behavioral health facility as set forth in Knott vs. Hughes Civil Action No. Y-80-2832 (Fed. Dist. Ct. Md). (b) Individuals become eligible to receive services based on the best clinical judgment of the professionals involved based on availability of allocated resources. (6) Category VI — Inappropriate Institutionalization. (a) To qualify for this priority category, the applicant shall be a: (i) Resident in a nursing facility and not meet the criteria for admission or retention for that facility; (ii) Resident of an intermediate care facility for individuals with intellectual disabilities or persons with related conditions (ICF/IID) and not meet the criteria for admission or retention for that facility as determined by the hearing examiner; (iii) Resident in a chronic hospital who does not meet the criteria for admission or retention for that facility; (iv) Resident in a behavioral health facility operated by the Department who has a developmental disability but is not an individual with an intellectual disability and who does not meet the criteria for admission or retention in a State psychiatric hospital and whose primary need is not for a mental health service. (b) An individual in this priority category shall also be in another priority category. (c) Funding may be allocated for one or more of the above groups in §B(6)(a)(i)—(iv) of this regulation. (d) Individuals become eligible to receive services based on the best clinical judgment of the professionals involved based on availability of allocated resources. (7) Category VII — Innovation or Demonstration Projects. (a) To identify those individuals for whom this priority category is appropriate, the Administration, after consultation with interested parties, shall publish a request for proposal (RFP) for innovation or demonstration projects. (b) To qualify for this priority category, an individual shall be identified in a proposal submitted to the Administration which is considered appropriate for funding by the Administration. (c) An individual served in this priority category may continue to receive services, to the extent that funds are allocated, after the termination of the innovation or demonstration period. (d) An individual in this priority category may also be in another priority category. (8) Eligible applicants may receive family support services and low intensity support services on a first-come, first-served basis, regardless of service priority determination. #### Regulation .08 Letter of Final Determination. *COMAR 10.22.12.08* A. Within 60 days of the receipt of the application, the final letter of determination indicating eligibility, priority, and service needs shall be sent to the applicant, caregiver, or other proponent, when one exists. B. The letter shall contain the following information: (1) A statement that the individual has a developmental disability or the individual does not have a developmental disability, but may be eligible for individual support services in accordance with Health-General Article, §7-403(c), Annotated Code of Maryland; (2) The nature of the services the individual may require; (3) The type of environment in which any needed services could be provided; (4) The types of evaluations, if any, the individual requires; (5) That determinations of priority status may be subject to modification if the applicant's or caregiver's circumstances change; (6) The individual has the right to an informal hearing to appeal the decision in accordance with COMAR 10.22.16; and (7) That the individual shall apply for Medical Assistance or other alternative funding before the initiation of services. #### Regulation .09 Local Review Committee. *COMAR 10.22.12.09* A. The regional director shall establish one or more local review committees. B. The function of the LRC is to review the service needs of eligible individuals and make recommendations regarding service needs to the regional director. The LRC shall be appointed by the regional director from among the following: (1) County government, including local health departments; (2) DDA; (3) Advocacy or developmental disability provider agencies; and (4) Parents. C. The regional director or designee shall serve as chairperson of the LRC. #### Regulation .10 Confirmation of Eligibility for Service Provision. *COMAR 10.22.12.10* A. Confirmation of eligibility, which is established before selection of the individual to receive services, is based on an evaluation in accordance with Health-General Article, §7-404, Annotated Code of Maryland. The exception shall be an emergency situation when a crisis needs to be immediately resolved as specified in Regulation .11B. B. The regional director shall be responsible for assuring that the evaluation required by Health-General Article, §7-404, Annotated Code of Maryland, has been completed before final determination of eligibility. The individual's evaluation shall confirm the following: (1) That the individual has a developmental disability as indicated by the preliminary determination; (2) The nature of the disability; (3) The nature of the services that the individual may require; (4) The type of environment in which any needed services could be provided with the least restriction on the liberty of the individual; and (5) The extent and timing of the services to be provided to the individual. C. If the regional director concludes that the evidence supports eligibility for service provision, a recommendation may be made to the Director that funding for services for the individual be approved. #### Regulation .11 Initiation of Services. *COMAR 10.22.12.11* A. Initiation of service delivery to an eligible individual seeking DDA-funded services shall be dependent upon: (1) Assigned service priority, except for family support services and low intensity support services which are provided on a first-come, first-served basis; (2) Availability and allocation of funds provided to the DDA; (3) Availability of an appropriate community vacancy; and (4) The individual's completing an application for Medical Assistance or other alternative funding. B. Emergency Situations. (1) If an emergency situation arises and immediate services are needed to resolve a crisis, the regional director may telephone the Director or the Director's designee to authorize the initiation of services for a maximum of 15 calendar days, provided that an: (a) Evaluation pursuant to Regulation .10B(2) is performed to confirm eligibility within 10 calendar days of the initiation of services. If the individual cannot afford evaluation services, the State shall arrange for them. (b) Application for services is processed pursuant to Regulation .04C and approved by the Director pursuant to Regulation .10. (2) If the Director or the Director's designee cannot be reached, the regional director may authorize services provided that the approval is obtained on the next working day. C. Ninety days after the receipt of services, the service needs and priority status of an individual shall be reviewed by the regional director or the regional director's designee, and adjusted if indicated. If the service meets the needs of the individual, the individual's name shall be removed from the waiting list for that service. D. Any time after the receipt of services, an eligible individual may: (1) Apply for or request a change in intensity of services or support, or apply for additional services; (2) Request a less intensive form of that service, and may receive the less intensive service if it is available. E. Individuals assigned to Category I who enter a State residential center because needed community services are not available or will not be available within a reasonable time, shall retain their eligibility and priority status for community services for 12 months after the date they enter the SRC. F. Except in an emergency situation or a case approved by the Director because of extenuating circumstances, DDA may not fund services for individuals with State-only dollars unless the individual has been denied: (1) Medical Assistance including waiver services; and (2) Related alternative funding. #### Regulation .12 Admission to and Discharge from DDA Community-Funded Services. *COMAR 10.22.12.12* A. Exception. This regulation does not apply to family services or low intensity support services. B. General Requirements for Assigning Vacancies or Providing Support Services. (1) Only those individuals seeking DDA-funded services and who have been deemed eligible by the DDA in accordance with Regulations .05—.10 of this chapter may be served by community service providers in DDA-funded vacancies or with DDA-funded support services. (2) Each provider shall report all DDA-funded vacancies to the appropriate regional office in accordance with a DDA-approved procedure, as soon as the potential vacancy is known to the provider. (3) The DDA shall authorize all admissions to or discharges from DDA-funded services in advance of these actions by providers. (4) In addition to a final determination of eligibility before authorizing the admission of an individual to a funded vacancy, the DDA shall also determine that the: (a) Individual is in need of the type of service to be provided; (b) Service is appropriate and is to be provided with the least restriction on the liberty of the individual; and (c) Individual wishes to be served by the particular provider or, at a minimum, agrees to accept the service from that provider. (5) If the individual does not qualify under Category I, the regional director shall determine that there is no one in that category who would be more appropriate for the vacancy or service. (6) If an appropriate vacancy exists, but the provider refuses to serve an individual whom the DDA has identified as qualified to receive services, the regional office may not authorize the provider to fill the vacancy. The funding for the vacancy may be transferred to another provider that offers an appropriate service and is willing to serve the individual. C. Specific Criteria for Assigning Community Program Vacancies or Providing Support Services. (1) The DDA shall develop a Statewide list of eligible individuals to fill a vacancy in a community program. The list should be organized according to priority ranking and according to the criteria for those categories. From this list: (a) The first eligible individual in the county where that vacancy exists who is appropriate for the service may be served; (b) Any other eligible individual whose name appears on the list before that of the individual described in §C(1)(a) of this regulation, may be served if appropriate for the service; and (c) The regional director shall define appropriateness for the service and shall consider the compatibility of residents for multi-person residences. (2) Individuals eligible under Category I, Crisis Resolution, as specified in Regulation .07B, may be served on a priority basis in an appropriate community program vacancy created by the movement of any client except a: (a) Client receiving services under the auspices of the Title XIX 1915(c) waiver; (b) Knott class member; (c) Grabau class member; or (d) Former SRC client who has been returned to the SRC. (3) Vacancies created by the movement of a waiver-eligible individual shall be filled by another client who is eligible for services under the waiver criteria as specified in COMAR 10.09.26. (4) Vacancies created by the movement of a Knott class member shall be filled in the following manner: (a) By another member of the Knott class; (b) If there is no Knott class member in need of that vacancy at the time that the vacancy occurs, the vacancy is to be filled by: (i) A member of the Grabau class, (ii) An individual eligible under Category I, Crisis Resolution, or (iii) An individual eligible under Category II, Crisis Prevention. (c) If the vacancy is filled by anyone other than a Knott class member, the Director may use funds provided for community expansion to create an equivalent placement for a Knott class member. (5) Vacancies created by the movement of a nonwaiver Grabau class member shall be filled in the following manner: (a) By another member of the Grabau class; (b) If there is no Grabau class member in need of that vacancy at the time that the vacancy occurs, the vacancy is to be filled by: (i) A member of the Knott class, (ii) An individual eligible under Category I, Crisis Resolution, or (iii) An individual eligible under Category II, Crisis Prevention; (c) If the vacancy is filled by anyone other than a Grabau class member, the Director may use funds provided for community expansion to create an equivalent placement for a Grabau class member. (6) Vacancies created by the movement of an institutional client out of a community day program shall be filled in the following manner: (a) By another institutional client; (b) If there is no appropriate institutional client at the time the vacancy occurs, the vacancy may be filled by an individual under Category I, II, or III in that order; (c) The regional director shall define “appropriate client”, taking into consideration the behavior of the client and the day program available; and (d) If the vacancy is filled by anyone other than an institutional client, the Director may use funds provided for community expansion to create an equivalent placement for an institutional client. (7) When filling vacancies for a multi-person community residence, such as an ALU or an IFC home, all available vacancies shall be filled through the procedures set forth in §B(1) of this regulation. (8) Vacancies for community expansion shall be filled in the order in which the individual's name appears on the Statewide eligibility list. When selecting individuals for multi-person community residential programs, the second and all subsequent individuals shall be selected as set forth in §C(1) of this regulation. D. Transfers to and from Community Program Vacancies. (1) Individuals currently enrolled in one provider's program may request a transfer to another provider by submitting a request in writing to the service coordinator or to the regional office. (2) The service coordinator shall review the request and make a recommendation to the regional director. (3) The regional director may authorize the request if an appropriate vacancy exists. (4) If an appropriate vacancy does not exist, the individual shall be placed on the region's waiting list for transfers based on the date of approval of the transfer. The individual on the transfer list shall have priority over those individuals in the Current Request priority category, but may not have priority over those individuals in the Crisis Resolution or Crisis Prevention priority categories. (5) Individuals requesting transfers outside the region shall have their requests forwarded to the appropriate regional office. (6) The individual has the right to an informal hearing to appeal the decision in accordance with COMAR 10.22.16. #### Regulation .13 Eligibility for Other Services. *COMAR 10.22.12.13* A. An individual's eligibility for services provided by any other public or private agency may not be affected by the individual's eligibility for services pursuant to these regulations. B. If an individual who is eligible for services funded by the DDA may also be eligible for services provided by another agency, the DDA or its agent shall refer the individual to that agency. #### Regulation .14 Reporting Requirements. *COMAR 10.22.12.14* The DDA access unit shall issue an annual report on the characteristics of applicants for DDA-funded services which shall include: A. Information on the total number of individuals waiting for services by service request and priority category; B. The number of individuals who have been added or removed by service request and priority category; and C. Other pertinent information which would assist in planning for future services or evaluating current performance. #### Regulation .15 Administrative and Judicial Review. *COMAR 10.22.12.15* A. Pursuant to COMAR 10.22.16: (1) On any action or inaction of the Secretary pursuant to Regulations .01—.14 of this chapter, an applicant for or recipient of DDA-funded services may request: (a) An informal hearing before the Secretary's designee, and (b) The Secretary to review the decision of the informal hearing if that decision is not acceptable. (2) Informal hearings under §A(1)(a) of this chapter shall be conducted in accordance with the Developmental Disabilities Law, Health-General Article, Title 7, Annotated Code of Maryland. (3) After a request for a review is made, the Secretary shall conduct the review in accordance with State Government Article, §§10-201—10-217, Annotated Code of Maryland. B. A person aggrieved by a final decision of the Secretary in a contested case as defined in State Government Article, §10-201, may take an appeal as allowed in State Government Article, §§10-215 and 10-216, Annotated Code of Maryland. C. Providers filing appeals in connection with these regulations shall do so in accordance with State Government Article, §§10-201—10-217 and 10-401—10-405, Annotated Code of Maryland. ### Chapter 13 — Admission of Individuals to State Residential Facilities Under the Jurisdiction of the Developmental Disabilities Administration **Authority:** Health-General Article, §7-502, Annotated Code of Maryland **Administrative History:** Effective date: April 1, 1974 **Administrative History:** Regulations .01 — .03 amended effective February 11, 1985 (12:3 Md. R. 245) **Administrative History:** Regulations .01 — .03 repealed effective September 5, 1988 (15:18 Md. R. 2151) **Administrative History:** Regulations .01 — .03 adopted effective September 5, 1988 (15:18 Md. R. 2151) **Administrative History:** COMAR 10.22.01 recodified to COMAR 10.22.13 effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .02B amended effective November 25, 2013 (40:23 Md. R. 1934) **Administrative History:** Regulation .03J amended effective November 25, 2013 (40:23 Md. R. 1934) #### Regulation .01 Scope. *COMAR 10.22.13.01* These regulations shall apply to each individual who has been admitted to any State residential center under the jurisdiction of the Developmental Disabilities Administration of the Maryland Department of Health. #### Regulation .02 Definitions. *COMAR 10.22.13.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) Admission. (a) “Admission” means the process by which an individual with an intellectual disability is accepted as a resident in a State residential center. (b) “Admission” includes the physical act of the individual entering the facility. (2) “Hearing” means the administrative proceedings which are conducted to determine whether the conclusions leading to an admission decision were properly drawn. (3) “Hearing examiner” means any impartial officer designated by the Secretary of Health to conduct hearings and make administrative decisions in accordance with these regulations. (4) “Proponent” means any person who has a legitimate interest in the welfare of an individual who is being served in a program licensed, operated, or funded by the Developmental Disabilities Administration. (5) “Reasonable time” means a period after a hearing in which an appropriate program or service shall be made available to an individual in order to avoid admission to a State residential center. This period of time may not exceed 90 days unless there is a program or service which is identified as available to the individual and which will accept the individual for services to begin on a fixed date. #### Regulation .03 Hearing Procedures. *COMAR 10.22.13.03* A. The hearing shall be conducted within 21 days after the admission of an individual to a State residential center. B. Written notice of the admission of an individual and of the date, time, and place of the individual's hearing shall be given: (1) On admission to the individual; or (2) As soon as possible, but not later than 5 days after the admission to legal counsel for the individual and to the proponent of the admission. C. The notice also shall state the: (1) Name of each proponent of the admission; (2) Rights of the individual who has been admitted to: (a) Consult with and be represented by a lawyer, and (b) Call witnesses and offer evidence at the hearing on admission; (3) Availability of the services of the Legal Aid Bureau, lawyer referral services, and other agencies that exist for the referral of individuals who need legal counsel; (4) Right of individuals with developmental disabilities, pursuant to Health-General Article, Title 7, Subtitle 10, and §7-1102, Annotated Code of Maryland; (5) Rights of the individual to release, pursuant to Health-General Article, §§7-506, 7-507, and 7-508, Annotated Code of Maryland. D. The parties to the hearing shall be the proponent and the individual. E. Each hearing which is held pursuant to Health-General Article, §7-503, shall be held in an appropriate room within the facility in which the individual is a resident, or in such other place as is deemed appropriate by the hearing examiner. F. The individual shall have the right to appear dressed in his or her own clothing, at the hearing, if he or she so desires. G. The records of the facility which address any aspect of the individual for whom the hearing shall be held shall, upon request, be made available to counsel for that person. H. A mechanical recording of the hearing shall be made, but a transcription need not be made unless an appropriate appeal is taken. I. Rules of Evidence--Notice. (1) The hearing examiner: (a) May admit and give probative effect to evidence which possesses probative value commonly accepted by reasonable and prudent persons in the conduct of their affairs; (b) Shall give effect to the rules of privilege recognized by law; (c) May exclude incompetent, irrelevant, immaterial, and unduly repetitious evidence. (2) All evidence, including records and documents in the possession of the agency, of which it desires to avail itself, shall be offered and made a part of the record in the case, and other factual information or evidence may not be considered in the determination of the case. Documentary evidence may be received in the form of copies or excerpts, or by incorporation by reference. (3) Each party shall have the right: (a) Of cross-examination of witnesses who testify; and (b) To submit rebuttal evidence. (4) The hearing examiner may take notice of judicially cognizable facts and, in addition, may take notice of general, technical, or scientific facts within the hearing examiner's specialized knowledge. Parties shall be notified either before or during the hearing, or by reference in preliminary reports or otherwise, of the material so noticed, and the parties shall be afforded an opportunity to contest the facts so noticed. The hearing examiner may use experience, technical competence, and specialized knowledge in the evaluation of the evidence presented. (5) The hearing examiner as designee of the Secretary of Health, upon request and good cause shown, shall issue appropriate process to compel the attendance of witnesses and the production of documents or other tangible evidence. This power is granted pursuant to Health-General Article, §2-104(k), Annotated Code of Maryland. (6) Telephoned Testimony. The hearing examiner, on the motion of the hearing examiner or upon request of a party to the hearing, may allow the testimony of any party or nonparty witness to be taken by telephone. The hearing examiner shall notify all parties in advance of the hearing that the testimony of a witness will be taken by telephone. When testimony is taken by telephone, the hearing examiner shall employ appropriate techniques to ensure that the testimony is fully audible to all parties present at the hearing and the testimony is made a part of the hearing record. The party shall be allowed to fully cross-examine any witness whose testimony is taken using this procedure. J. Admission Requirements. (1) At the hearing, in order to certify the admission of the individual, it shall be affirmatively shown by clear and convincing evidence that the conclusions leading to the decision to admit the individual were supported by the following findings: (a) That the individual whose admission is sought has an intellectual disability; (b) That the individual needs residential services for the provision of adequate habilitation; and (c) That there is no less restrictive setting in which the needed services can be provided that is available to the individual, or will be available to the individual within a reasonable time. (2) If the hearing examiner finds from the admissible evidence that the conclusions leading to the admission decision are invalid, the hearing examiner shall so certify and the individual shall be released from the State residential center. (3) If the hearing examiner finds from the evidence presented that all of the admission requirements have been proved, the hearing examiner shall so certify and the individual's admission shall be considered approved. (4) If the hearing examiner certifies the admission of an individual to a State residential center, the hearing examiner shall, at the conclusion of the hearing, write on the certification form any additional services of habilitation that are not included in the evaluation report, but that the hearing officer finds from the evidence are needed by the individual. (5) If the hearing examiner certifies the admission of an individual to a State residential center, at the conclusion of the hearing, the examiner shall advise the individual and the legal counsel of the individual's right to seek judicial release from the State Residential Center under Health-General Article, §7-507, Annotated Code of Maryland, and of his right to file a petition for habeas corpus under Health-General Article, §7-506, Annotated Code of Maryland. The hearing examiner shall also advise individual and legal counsel of the individual's right under the appeal provision of State Government Article, §§10-215 and 10-216, Annotated Code of Maryland. The individual's rights shall be communicated in a form of language that the individual understands. K. Hearing Examiners' Powers. In addition to other powers and authority granted by law, the hearing examiner shall: (1) Administer oaths and affirmation; (2) Issue summonses for the attendance of witnesses at the hearings and subpoenas requiring the production of physical evidence; (3) Rule upon offers of proof by the parties; (4) Consider and rule upon all procedural and other motions appropriate to the proceedings; (5) Examine witnesses; (6) Maintain order and limit unduly repetitious or irrelevant testimony or argument. ### Chapter 14 — Low Intensity Support Services (LISS) Program **Authority:** Health-General Article, §§7-703, 7-708, 7-717, and 7-904, Annotated Code of Maryland **Administrative History:** Effective date: July 23, 2012 (39:14 Md. R. 838) **Administrative History:** Regulation .03B amended effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .05 amended effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .06 amended effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .07 amended effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .08 amended effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .09A amended effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .10 amended effective October 24, 2016 (43:21 Md. R. 1166) **Administrative History:** Regulation .11 adopted effective October 24, 2016 (43:21 Md. R. 1166) #### Regulation .01 Purpose. *COMAR 10.22.14.01* The purpose of this chapter is to establish a Low Intensity Support Services (LISS) Program in the Developmental Disabilities Administration (DDA). #### Regulation .02 Rationale. *COMAR 10.22.14.02* A. The Program shall: (1) Assist a family to provide for the needs of a child or an adult with developmental disability living in the home; or (2) Support an adult with developmental disability living in the community. B. Services shall be: (1) Flexible to meet the needs of individuals or families; and (2) Readily adaptive to changing needs. C. The Program makes use of resources available in the community while, at the same time, building on the individual’s existing support network. D. Services provide quick access to supports for family and individual. #### Regulation .03 Definitions. *COMAR 10.22.14.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Developmental Disabilities Administration (DDA) under the Maryland Department of Health. (2) “Agency” means the selected licensed family and individual support program that administers the Program on behalf of the Administration. (3) “Camp” means a day camp, residential camp, travel camp, or trip camp that: (a) During a calendar year, accommodates seven or more campers who are unrelated to the operator; (b) Provides primarily recreational activities or has a substantial recreational component; and (c) Operates on private property or private facilities, whether leased or owned, public property, or public facilities. (4) “Child care” means the care or supervision for an individual, younger than 21 years old, who has a disability or other emotional, developmental, physical, educational, or medical need necessitating child care when the individual’s parent or legal guardian gives the individual’s care over to another for some portion of a 24-hour day as a supplement to the parent’s or guardian’s primary care of the child. (5) “Day care” means the care provided to an individual 21 years old or older, who has a disability or other emotional, developmental, physical, educational, or medical need necessitating care from an adult day care center. (6) “Eligible disability” means the individual has a severe chronic disability that: (a) Is attributable to a physical or mental impairment, other than the sole diagnosis of mental illness, or to a combination of physical and mental impairments; and (b) Is likely to continue indefinitely. (7) “Dietitian and nutritionist services” mean: (a) Nutrition care planning, nutrition assessment, and dietetic instruction; and (b) Services within the scope of practice of the nutritionist's or dietitian's license, as defined by: (i) Health Occupations Article, Title 5, Annotated Code of Maryland; and (ii) Regulations under COMAR 10.56 for the Board of Dietetic Practice. (8) “Health services” means services: (a) Provided by individuals regulated under the Health Occupations Article, Annotated Code of Maryland; (b) That the respective licensing Board approves as a valid treatment for the presenting problem; and (c) That include health assessments such as psychological, neuropsychological, dental, and speech-language assessments. (9) Housing Adaptations and Barrier Removals. (a) “Housing adaptations and barrier removals” means those physical adaptations or modifications to the individual’s or family’s home which are required to make it accessible to the individual because of the: (i) Physical structure of the residence; or (ii) Individual’s specific functional needs. (b) “Housing adaptations and barrier removals” may include but are not limited to: (i) Visual fire alarms; (ii) Ramps; (iii) Grab bars or handrails; (iv) Stair glides; (v) Widening of doorways; (vi) Modification of bathroom or kitchen facilities to make them physically accessible; (vii) Specialized electrical and plumbing systems to accommodate the medical equipment and supplies which are necessary for the individual's welfare; (viii) Locks, buzzers, or other devices on doorways to prevent or stop wandering; and (ix) Home modifications to help a individual identify the physical environment. (10) “Most integrated setting” means a setting that enables individuals with disabilities to interact with non-disabled persons to the fullest extent possible. (11) “Program” means the Low Intensity Support Services Program that the Administration operates by contracting with approved Agencies. (12) “Random selection process” means a system used to identify the applicants who will be considered for funding during Round 1 and Round 2 of each fiscal year, by using an automated system that does not consider the identity or any other personal aspect of the applicants. (13) “Services” means low intensity support services as describe in this chapter. (14) Specialized Equipment and Assistive Technology. (a) “Specialized equipment and assistive technology” means non-experimental technology or adaptive equipment which: (i) Enables an individual to live in the community and to participate in community activities; and (ii) Meets applicable standards of manufacture, design, usage, and installation. (b) “Specialized Equipment and assistive technology” may include: (i) Environmental control units for participants' homes to allow spontaneous or programmed control of household appliances and other home devices; (ii) Devices with web-based operating systems, software, and computer accessories that enable participants to function more independently; (c) Maintenance and repair of the covered assistive technology devices and equipment, as necessary; (d) Augmentative communication and communication-enhancement devices; (e) Aids for daily living and self-help aids used in activities such as eating, bathing, cooking, dressing, toileting, and home maintenance; and (f) Equipment needed to adapt the individual's or family's automotive vehicle for personal transportation such as: (i) Adaptive driving aids; (ii) Hand controls; and (iii) Wheelchair lifts, and other lifts used for personal transportation. (15) “Therapy” means occupational, physical, speech, or behavioral therapy that is not funded by other State funded programs or by health insurance, including the Medical Assistance Program. (16) “Therapeutic summer program” means a set of services designed to provide medical, behavioral, or psychological therapies, such as speech, applied behavior analysis, and occupational, through a variety of activities, in a safe environment, which are recommended by a licensed professional, and provided by clinical staff with clinical oversight. (17) “Usual, customary, and reasonable” means the amount paid for a service in a geographic area that is based on what providers in the area typically charge for the same or similar service, so long as that charge is reasonable. #### Regulation .04 Setting and Location. *COMAR 10.22.14.04* Services shall be provided within the individual’s home or a community setting in the most integrated setting. #### Regulation .05 Application and Eligibility. *COMAR 10.22.14.05* A. An individual shall submit to the Department: (1) The completed LISS application form; (2) For applicants younger than 21 years old, one of the following, demonstrating that the applicant meets the eligibility requirements for LISS: (a) A finalized Individual Educational Program (IEP) from the current calendar year that identifies an eligible disability and that is in effect as of the date of the LISS application; or (b) A statement written by a licensed physician, confirming that the individual has an eligible disability; (3) For applicants 21 years old or older, one of the following, demonstrating that the applicant meets the eligibility requirements for LISS: (a) A statement written by a licensed physician within the last 3 years, confirming that the individual has an eligible disability; (b) A psychological evaluation completed by a licensed professional within the last 3 years, confirming that the individual has an eligible disability; (c) An evaluation completed by an Occupational Therapist, a Division of Rehabilitation Services evaluator, or another licensed professional within the last 3 years, confirming that the individual has an eligible disability; or (d) A finalized IEP dated within 3 years after the date on which the applicant exited the school system, confirming that the individual has an eligible disability; and (4) Upon request of the DDA, additional written evidence demonstrating that the criteria for specific services are met. B. Eligibility. (1) To be eligible for the Program, an individual: (a) Shall be a Maryland resident and provide proof of address for the current calendar year; (b) Shall have an eligible diagnosis; (c) Shall provide proof of identity; (d) May not be enrolled in any Maryland Medicaid home and community-based services waiver at the time of the random selection process, except that this restriction does not apply to applicants enrolled in the Maryland Model Waiver Program; (e) May be enrolled in the Rare and Expensive Case Management (REM) Medicaid Program at the time of the random selection process; (f) Shall submit a fully completed LISS application by the due dates established by the DDA; and (g) Shall be selected by the random selection process. (2) An individual currently receiving DDA services, other than coordination of community services, may not receive LISS funding under this chapter. (3) An individual who received funding in Round 1 of the random selection process may not receive funding in Round 2 in the same fiscal year, even if the entire maximum amount of $2,000 was not awarded to the individual in Round 1. C. The agency shall approve services for an eligible individual: (1) Who is selected by the random selection process; and (2) Whose requested services, items, and providers comply with the provisions of this chapter. #### Regulation .06 Scope. *COMAR 10.22.14.06* A. Services funded under this program are intended to be, and are limited to, those that: (1) Enhance the individual’s health or increase safety in the home environment; (2) Support the individual to participate in the community; (3) Enable the individual to remain in the individual’s own home or with the individual’s family; (4) Strengthen the family’s ability to support the individual; or (5) Enable the individual to develop and maintain skills. B. Services funded under this program may not duplicate services available to the individual in the community, education systems, or under an existing health plan, including Medical Assistance services. C. To be approved for funding, requested services and items: (1) Shall be rendered by a provider whose administrative fee does not exceed 15 percent of the total cost of the item or service; (2) May not be provided by a legally responsible person, as defined in Health General Article, §7-701(c), Annotated Code of Maryland; (3) Shall be rendered by a provider who is licensed by the State to perform the service; (4) Shall be received: (a) Except in accordance with §C(4)(b) of this regulation, within the same fiscal year as the request; and (b) For summer camps, summer programs, and therapeutic programs, in June of the current fiscal year, or in July and August of the following fiscal year; and (5) Shall be approved in accordance with this chapter. #### Regulation .07 Covered Services. *COMAR 10.22.14.07* A. Services include supports involving: (1) Attendant care services, including personal care; (2) Camps that are: (a) Approved by the MDH in accordance with COMAR 10.16.06; (b) Accredited by the Maryland State Department of Education; (c) Accredited by the American Camping Association certification; (d) Approved by a State governmental entity; or (e) Approved by the Developmental Disabilities Administration; (3) Child care that is provided in accordance with COMAR 13A.15, 13A.16, and 13A.18; (4) Community integration services, including recreation programs; (5) Counseling, individual and family; (6) Day care provided in accordance with Health General Article, §14-201(b) or §14-301(b), Annotated Code of Maryland; (7) Employment-related services; (8) Health services, including dietetic and nutritional services; (9) Housing adaptations and barrier removals provided that the applicant or the applicant’s family owns the property needing the adaptation; (10) Identification services; (11) Medical equipment purchase, rental, and repair; (12) Recreation programs; (13) Respite care and approved camps; (14) Services to mediate, provide advice, or support the person or family to address their needs; (15) Specialized equipment and assistive technology; (16) Therapeutic services; (17) Therapeutic summer programs; (18) Training and support for self-advocacy; (19) Transportation. (20) Tuition for post-secondary academic and vocational services; (21) Tutoring for post-secondary academic and vocational services; and (22) Repairs of vehicles that have been modified or adapted with specialized equipment to meet the needs of the eligible individual. B. The Administration may approve other services that meet the requirements of Regulation .06 of this chapter. C. The agency approving or procuring requested dietitian and nutritionist services referenced in §A(7) of this regulation shall be sensitive to the educational background, culture, religion, eating habits, preferences, and general environment of the individual. D. To be approved for funding, all requested medical services, and therapies: (1) Shall be prescribed by a professional authorized to do so under the Health Occupations Article, Annotated Code of Maryland, in the relevant field; (2) Shall be provided or supervised by an organization authorized to do so under the Health Occupations Article, Annotated Code of Maryland, in the relevant field; (3) Shall be prescribed for treatment of a specified illness or condition, or for amelioration of the symptoms of a specified illness or condition; (4) Shall be a treatment that is approved by the: (a) Respective Health Occupations licensing board; and (b) The Federal Drug Administration (FDA), if the FDA regulates the treatment; and (5) May not be: (a) Related to the individual’s primary or secondary education; and (b) Covered by the individual’s IEP. E. To be approved for funding, all providers of housing adaptations and barrier removal services shall: (1) Be properly licensed or certified by the State to provide the service being rendered; (2) Be bonded as is legally required; (3) Obtain all required State and local permits; (4) Pass final required inspections; and (5) Perform all work in accordance with State and local building codes. #### Regulation .08 Program Funding. *COMAR 10.22.14.08* A. The Program is not an entitlement program and does not create a right to funding. B. Funding is not transferable, and the amount funded may not exceed the amount initially requested on the application. C. Amount of Funding. (1) The agency may approve funding for an eligible individual for services up to $2,000 per fiscal year. (2) Requests for amounts exceeding $2,000 may not be considered. D. The agency may not fund a request for services unless the service or support meets the requirements of this chapter. E. Exclusions. (1) Treatments and therapies that are not generally accepted by the relevant scientific community may not be provided or funded. (2) The Program may not provide or fund the following: (a) Housing adaptations or improvements to an individual’s home that adds to the home’s total square footage; and (b) Adaptations or modifications that restrict an individual’s movement or jeopardize the individual’s welfare. (3) The Program may not provide or cover the following: (a) Cash; (b) Case management; (c) Gift cards; (d) Presents; (e) Toys, except those recommended by an individual authorized under the Health Occupations Article, Annotated Code of Maryland, for specified therapeutic purposes; (f) Vacations; (g) Vehicle gas, tires, registration fees, loan payments, insurance coverage, and penalties for violations, such as tickets and fines; and (h) Housing assistance, including eviction assistance, utility disconnection, and deposits. #### Regulation .09 Appeals. *COMAR 10.22.14.09* A. Pursuant to Health-General Article, §7-406, Annotated Code of Maryland, and COMAR 10.22.16: (1) On any action or inaction of the Secretary under Regulations .01 — .08 of this chapter, other than non-selection through the random selection process, an applicant for services may request: (a) An informal hearing before the Secretary’s designee; and (b) The Secretary to review the decision of the informal hearing if that decision is not acceptable; (2) Informal hearings under §A(1)(a) of this regulation are conducted in accordance with COMAR 10.22.16; and (3) After a request for a review is made, the Secretary shall conduct the review in accordance with Title 10, Subtitle 2 of the State Government Article, Annotated Code of Maryland. B. The Secretary may deny a request for hearing if the reason for the appeal is to contest a denial of services due to lack of available budgeted funds. C. A person aggrieved by a final decision of the Secretary in a contested case as defined in State Government Article, §10-201, Annotated Code of Maryland, may take an appeal as allowed in State Government Article, §§10-215 and 10-216, Annotated Code of Maryland. #### Regulation .10 Program Agencies — Eligibility and Responsibilities. *COMAR 10.22.14.10* A. The agency that administers the Program shall: (1) Be licensed under COMAR 10.22.06 as an Individual and Family Support Program; (2) Have been awarded a contract to administer the Program under the Administration’s competitive procurement process; and (3) Maintain an operational procedure manual that is approved by DDA. B. Funding of Services. The agency shall fund services as follows: (1) Fund only services that meet the requirements of this chapter; (2) Fund services at the rates set forth in the contract; (3) Fund procured services based on the usual, customary, and reasonable rate for the service provided; and (4) Fund housing adaptations and barrier removals referenced in Regulation .07A(8) of this chapter, including the cost of the physical adaptation and associated costs for installation. C. The agency shall deny funding if: (1) The applicant does not meet eligibility criteria; (2) The service or item requested is not permitted to be provided or funded by this chapter; or (3) The provider of the service does not meet the requirements of this chapter. #### Regulation .11 Implementation Date. *COMAR 10.22.14.11* This chapter shall be implemented July 1, 2015. ### Chapter 15 — Waiting List Equity Fund **Authority:** Health-General Article, §7-206, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .10 adopted as an emergency provision effective February 27, 1996 (23:6 Md. R. 470); emergency status extended to September 23, 1996 (23:14 Md. R. 1006); adopted permanently effective September 23, 1996 (23:19 Md. R. 1376) **Administrative History:** COMAR 10.22.08 recodified to COMAR 10.22.15 effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .02B amended effective November 25, 2013 (40:23 Md. R. 1934) #### Regulation .01 Scope. *COMAR 10.22.15.01* A. These regulations address the management and use of money in the waiting list equity fund. B. The waiting list equity fund may not be used to supplant funds requested or appropriated for: (1) Emergency community placements; or (2) Transitioning students. #### Regulation .02 Definitions. *COMAR 10.22.15.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Developmental Disabilities Administration (DDA). (2) “Appropriate evaluation” means the assessment of an individual using accepted professional standards to determine the presence or absence of a developmental disability: (a) As defined in Health-General Article, §7-101(e), Annotated Code of Maryland; or (b) That qualifies the individual for individual support services only as defined in Health-General Article, §7-403(c), Annotated Code of Maryland. (3) “Community placement” means when an individual is discharged from a State residential center into the community and receives community-based services. (4) “Department” means the Maryland Department of Health. (5) “Developmental disability” means a severe, chronic disability of an individual that: (a) Is attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; (b) Is manifested before the individual becomes 22 years old; (c) Is likely to continue indefinitely; (d) Results in an inability to live independently without external support or continuing and regular assistance; and (e) Reflects the need for a combination and sequence of special, interdisciplinary, or generic care, treatment, or other services that are individually planned and coordinated for the individual. (6) “Eligibility for support services only” means an individual has a severe chronic disability that is: (a) Attributable to a physical or mental impairment other than the sole diagnosis of mental illness, or to a combination of mental and physical impairments; and (b) Likely to continue indefinitely. (7) “Family caregiver” means any of the following who is residing with the eligible individual: (a) Spouse; (b) Biological, adoptive, or foster parent; (c) Guardian; (d) Sibling; (e) Grandparent; or (f) Other related next of kin. (8) Family Support Services. (a) “Family support services” means a program designed to enable a family to provide for the needs of a child with developmental disability living in the family home. (b) “Family support services” includes: (i) Individual and family counseling; (ii) Personal care; (iii) Day care; (iv) Specialized equipment; (v) Health services; (vi) Respite care; (vii) Housing adaptations; and (viii) Transportation. (9) “Individual” means the person for whom an application for services has been filed with the Administration. (10) Individual Support Services. (a) “Individual support services” means an array of services that are designed to increase or maintain an individual's ability to live alone or in a family setting. (b) “Individual support services” includes: (i) In-home assistance with meals and personal care; (ii) Counseling; (iii) Physical, occupational, or other therapies; (iv) Architectural modification; and (v) Other services that the Administration considers appropriate to meet an individual's needs. (11) “Individualized community integration day services” means any full-time or part-time program of habilitation, health-related services, scheduled training, or skills development activities conducted outside the individual's home. (12) Individualized Supported Living Arrangements Services. (a) “Individualized supported living arrangements services” means residential services provided in alternative living units (ALUs), community supported living arrangements (CSLA), and any other community residential arrangement which is individualized. (b) “Individualized supported living arrangements services” does not include group homes. (13) “Previous resident of a State residential center” means an individual who: (a) Was a resident of that facility on the first day of that fiscal year; and (b) Had resided at the facility at least 120 days during the 180 days immediately preceding placement in the community. (14) “Respite care” means short-term care not to exceed 14 consecutive days or 28 days in a 12-month period that is made available to provide relief for the individual with whom the developmentally disabled individual ordinarily lives. (15) “State residential center (SRC)” means a place that: (a) Is owned and operated by the State; (b) Provides residential services for an individual with an intellectual disability and who, because of an intellectual disability, requires specialized living arrangements and meets the criteria under Health-General Article, §§7-502 and 7-505, Annotated Code of Maryland; and (c) Admits nine or more individuals with intellectual disabilities. (16) “Supported employment” means paid competitive employment in an integrated work setting consistent with the federal Rehabilitation Act 1992 amendments. (17) “Waiting list” means those individuals who have: (a) Applied for services from the Administration in accordance with COMAR 10.22.12.04; (b) Been considered eligible for services in accordance with COMAR 10.22.12.06; and (c) Not yet received services for which they have applied from the Administration. (18) “Waiting list equity fund (WLEF)” means the fund established according to the requirements specified in Health-General Article, §7-206, Annotated Code of Maryland. #### Regulation .03 Establishment of the Waiting List Equity Fund. *COMAR 10.22.15.03* A. The waiting list equity fund is a nonlapsing fund established to ensure that when an individual leaves the State residential center to be served in the community, the net average cost of serving the individual in the SRC is applied to: (1) The individual's community placement; (2) Community services needed to sustain the individual's community placement; and (3) Provide community-based services to individuals not yet receiving services. B. The WLEF consists of funds that are equal to the cost of providing services to an individual in an SRC for a fiscal year, or part of a fiscal year in which the individual is: (1) No longer served in the SRC; and (2) Provided community-based services as specified in Regulation .04 of this chapter. C. In determining the contribution to the WLEF, the Administration shall calculate the cost of providing services to an individual in an SRC by: (1) Dividing the SRC's appropriation by the daily average census reported in the SRC's annual operating budget for the last full fiscal year the individual was served in the SRC, prorated over the number of months the individual is served in the community; and (2) Subtracting the following: (a) The average annual itemized expenses associated with institutional services and administrative overhead costs that are demonstrated to be directly attributable to the individuals remaining in the SRC, (b) The cost for new admissions certified with the provisions of Health-General Article, §§7-502 and 7-503, Annotated Code of Maryland, (c) The cost for respite care in accordance with Health-General Article, §7-509, Annotated Code of Maryland, which is based on the identification of the actual, specific costs directly attributable to serving individuals in the SRC with respite care services, (d) The cost for court-ordered commitments, and (e) Federal revenues under the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) attributable to direct client cost. D. The Administration shall allocate to the WLEF overhead savings derived from the closing of an individual cottage or cottages. #### Regulation .04 Submission of Annual Budget. *COMAR 10.22.15.04* A. When submitting its annual budget request for community services programs, the Administration shall include funds for the ongoing cost of services for the number of: (1) Previous residents placed from the SRC into the community in the previous fiscal year using the WLEF; (2) Individuals receiving emergency placements using the WLEF; and (3) Individuals receiving nonemergency placements using the WLEF. B. The Administration shall reduce the budget submission for the SRC by the net average cost of serving an individual in that center, as defined in Regulation .03C(2) of this chapter. C. The Administration shall calculate the net average cost on a prorated basis if an individual was placed in the community for less than the entire fiscal year. D. The Administration may increase or decrease the budget request for each SRC to account for the increased cost of services to the remaining residents of the SRC. E. If the Administration requests additional amounts for the purpose of funding community placements for current residents of SRCs, the Administration shall request that additional funding in a separate category from funds for the WLEF. #### Regulation .05 Administration of Fund. *COMAR 10.22.15.05* A. The Administration shall authorize the funding of services through the WLEF, administered as a nonlapsing revenue account, only to the extent that an appropriation has been made and that funds are available in the WLEF. B. The WLEF may be used to provide services to individuals who are: (1) In crisis and need emergency services; and (2) Not in crisis and do not need emergency services. C. The WLEF may not be used to supplant funds appropriated for: (1) Emergency community placements; or (2) Transitioning students. D. To determine the amount of funds available from the WLEF at any time during a fiscal year, the Administration shall project the cost for community services for that year for each individual whose services are funded through the WLEF. E. If approved by the Administration, the Administration shall include the following items in the projected costs: (1) The cost of the services provided to the individual; (2) Any increase in the cost of services being provided to the individual; and (3) Any increase in costs due to a change in the amount or type of services provided to the individual. F. The Administration shall account for all transactions into and out of the WLEF at the project level. G. The Administration shall ensure that all interest earned on the money in the WLEF remains with the fund. H. The availability of funding through the WLEF does not establish an entitlement to services. #### Regulation .06 Eligibility Criteria. *COMAR 10.22.15.06* A. To be eligible for services funded from the waiting list equity fund, an individual shall: (1) Be a resident of Maryland; (2) Have an appropriate evaluation that finds that the individual: (a) Has a developmental disability, or (b) Is eligible for support services; (3) Leave a State residential center on or after October 1, 1994, to be served in community-based services as specified in Regulation .05A of this chapter; or (4) Be in the community on the waiting list for community-based services in one of the following categories: (a) Crisis resolution, (b) Crisis prevention, or (c) Current request. B. A determination made under §A(2) of this regulation may be reopened on the provision of an additional evaluation after 1 year from the initial evaluation. #### Regulation .07 Services. *COMAR 10.22.15.07* A. The Administration shall ensure that the waiting list equity fund is used to provide the following community-based services to eligible individuals in accordance with the individual's needs: (1) Individual and family support services; (2) Respite care; (3) Supported employment; (4) Individualized community integration day services; and (5) Individualized supported living arrangements services. B. The Administration shall consider the following criteria when deciding priority for services: (1) 80 percent of the WLEF monies are to be spent for individuals not in crisis and who do not need emergency services; (2) 20 percent of the WLEF monies are to be spent for individuals in crisis and who need emergency services after all emergency funds have been expended on a regional basis; (3) Individuals who are not in crisis and who do not need emergency services are defined in COMAR 10.22.12; (4) Individuals who are in crisis and who need emergency services are defined in COMAR 10.22.12; and (5) For nonemergencies, individuals and their families shall receive services in the following priority order: (a) Oldest age of family caregiver, by the date of birth, in descending order, and (b) If there are two caregivers of the same age next to be served and funding is available to support only one, priority is given to the individual on the crisis prevention list. #### Regulation .08 Review and Reporting Requirements. *COMAR 10.22.15.08* A. On or before January 1 of each year, the Administration shall prepare a report to be submitted to the General Assembly and the Department of Fiscal Services on the waiting list equity fund. B. The Administration shall include in the report: (1) An accounting of all receipts and expenditures to and from the fund; (2) The number of individuals who left and entered State residential centers during the previous year; (3) The number of additional individuals who were on the waiting list for services from the Administration during the previous year; and (4) An accounting of each factor used to determine the cost of providing services to an individual in a State residential center in accordance with the provisions stated in Health-General Article, §7-206, Annotated Code of Maryland. C. The Administration shall: (1) Review the needs of individuals on the waiting list by July 1, 1998; and (2) Modify these regulations, as appropriate, to respond to the needs of the individuals on the waiting list. #### Regulation .09 Administrative and Judicial Review. *COMAR 10.22.15.09* A. An individual has the right to appeal an action or inaction with respect to this chapter in accordance with Health-General Article, §7-406, Annotated Code of Maryland, and COMAR 10.22.16. B. An individual may prevail at the appeal only upon a showing that the agency has violated statutory or regulatory provisions by its action or inaction. #### Regulation .10 Eligibility for Other Services. *COMAR 10.22.15.10* A. An individual's eligibility for services provided by any other public or private agency may not be affected by the individual's eligibility for services under this chapter. B. An individual who is eligible for services funded by the Administration may also be eligible for services provided by another agency. ### Chapter 16 — Informal Hearings Under the Maryland Developmental Disabilities Law **Authority:** Health-General Article, §§7-401 and 7-406, Annotated Code of Maryland **Administrative History:** Effective date: February 21, 1975 (2:7 Md. R. 490) **Administrative History:** Preface amended effective December 29, 1975 (3:4 Md. R. 217) **Administrative History:** Chapter, Public and Private Residential Care Facilities Serving the Mentally Retarded (I.C.F—M.R.), repealed effective December 28, 1987 (14:26 Md. R. 2747) **Administrative History:** Regulations .01—.13 Informal Hearings Under the Maryland Developmental Disabilities Law, adopted effective December 25, 1989 (16:25 Md. R. 2713) **Administrative History:** COMAR 10.22.04 recodified to COMAR 10.22.16 effective July 26, 1999 (26:15 Md. R. 1148) **Administrative History:** Regulation .03B amended effective December 31, 2018 (45:26 Md. R. 1245) #### Regulation .01 Scope. *COMAR 10.22.16.01* This chapter applies to the hearing which an applicant for or a recipient of Developmental Disabilities Administration services may request under Health-General Article, §7-406(a)(1), Annotated Code of Maryland. Nothing in these regulations shall be construed to create an entitlement to services provided or funded by the Department or the Administration. #### Regulation .02 Purpose. *COMAR 10.22.16.02* The purpose of the informal hearing procedure is to seek informal and expeditious resolution when an applicant for or recipient of services is dissatisfied as a result of the Secretary's actions or inactions under Health-General Article, Title 7. #### Regulation .03 Definitions. *COMAR 10.22.16.03* A. In this chapter the following terms have the meanings indicated. B. Terms Defined. (1) “Action or inaction of the Secretary” means a decision of the Deputy Secretary or an authorized representative of the Deputy Secretary, that: (a) Denies an application by an individual for eligibility for services; (b) Denies a request for services made by a recipient of services; (c) Terminates, reduces, suspends, or withdraws services for a recipient of services; or (d) Otherwise denies a request made by a recipient of services that is related to DDA services. (2) “Administration” means the Developmental Disabilities Administration (DDA). (3) “Appellant” means the person or that person's representative who has applied for or received Administration services and who has requested a hearing pursuant to Health-General Article, §7-406, Annotated Code of Maryland. (4) “Applicant for services” means a person who has applied for services and is subject to the Administration's determination of eligibility. In addition, the following representatives are considered applicants for the purpose of these regulations: (a) A parent of an applicant who is a minor; (b) The applicant's court-appointed guardian of the person; (c) An attorney representing the applicant; and (d) A person or agency who has a legitimate interest in the welfare of the individual applying for DDA services or being served in a DDA licensed, operated, or funded program. (5) “Department” means the Maryland Department of Health. (6) “Department's representative” means the person designated by the Director to represent the Department in the hearing and to defend the action or inaction of the Secretary. (7) “Director” means the Director of the Developmental Disabilities Administration. (8) “Hearing” means the informal hearing provided for in Health-General Article, §7-406(a)(1), Annotated Code of Maryland. (9) “Party” means an appellant or the Department. (10) “Recipient of services” means a person who has received Administration services. In addition, the following representatives are considered recipients for the purpose of these regulations: (a) A parent of a recipient who is a minor; (b) The recipient's court-appointed guardian of the person; (c) An attorney representing the recipient; and (d) A person or agency who has a legitimate interest in the welfare of the individual applying for DDA services or being served in a DDA licensed, operated, or funded program. (11) “Secretary” means the Secretary of Health and or a representative appointed by the Secretary. (12) “Secretary's designee” means the employee of the Department chosen by the Director to conduct the hearing and make administrative decisions in accordance with these regulations. #### Regulation .04 Notification of Right to Request a Hearing. *COMAR 10.22.16.04* The Administration shall: A. Provide written notification of the right to request a hearing and the method of obtaining the hearing to each applicant for or recipient of services at the time of application, and at any time the Administration decides to deny, terminate, reduce, suspend, withdraw or transfer, or otherwise significantly alter any service to an applicant or recipient; B. Include in the notification the following statements: (1) That the applicant or recipient: (a) Has a right to a hearing upon request regarding any action or inaction of the Secretary made under Health-General Article, Title 7, Annotated Code of Maryland, which affects service provision to the applicant or recipient, (b) May choose to waive the right to an informal hearing, and (c) Has the right to a formal hearing in accordance with State Government Article, Title 10, Subtitle 2; (2) If a decision has been made by the Secretary, the factual basis for the decision; (3) That a hearing shall be requested within 45 days of the date the notification is postmarked if a decision has been made by the Department, or within 45 days following the action or inaction which is the subject of the appeal; (4) The procedure the applicant or recipient is required to follow in order to timely request a hearing; and (5) That unless an informal or formal hearing is requested within the prescribed time period, the Secretary's intended action will become final; C. Enclose with the written notification a form to be used to request a hearing. #### Regulation .05 Request for Hearing. *COMAR 10.22.16.05* A. An applicant or recipient, or the applicant's or recipient's representative, may request a hearing by mailing or delivering a clear, written statement to the Director of the Administration. The request shall state: (1) That the applicant or recipient desires a hearing; and (2) The specific action or inaction of the Secretary which the applicant or recipient seeks to challenge. B. The Administration shall acknowledge in writing a request for a hearing within 10 days of the postmark of the request. C. The Administration shall give reasonable advance notice in writing to the appellant of the issue or issues to be decided, the date, time, and place of the hearing, the right to be present, the right to be represented by an attorney, and the right to request and present witnesses and documentary evidence. D. Unless agreed upon by all parties, the Administration shall hold the hearing not sooner than 10 days but not later than 30 days after the mailing of the acknowledgement. The Administration may consolidate various requests for hearings made by or on behalf of a particular individual when there is significant similarity in facts or issues to be resolved. E. The Administration shall make reasonable efforts to schedule the hearing at a time and place convenient to all parties. F. A request for a hearing shall be made within 45 days of the postmark of the notification specified in Regulation .04A, or if Regulation .04A does not apply, within 45 days following the action. When the subject of the appeal is an inaction, a request for a hearing shall be made within 45 days after the applicant or recipient actually knew or should reasonably have known of the inaction. G. A request for an extension of the time to request a hearing may be granted by the Secretary's designee for good cause shown. H. The Department may dismiss a request for a hearing when it has been withdrawn or abandoned by the appellant. The Department may find that a request for a hearing has been abandoned if, after receiving proper notice, the appellant: (1) Does not appear for the hearing on the established date; and (2) Fails to notify the Department of the reason for nonappearance. I. The Department is only required to grant one informal hearing as to any one action or inaction of the Secretary. #### Regulation .06 Implementation of Action of the Secretary. *COMAR 10.22.16.06* A. The action of the Secretary, which is the subject of a request for a hearing, may not be implemented unless the: (1) Secretary has determined that an emergency exists when to delay action for a hearing would have a serious and adverse affect on the health or safety of any person; (2) Applicant or recipient has withdrawn or abandoned the request for a hearing; or (3) Applicant or recipient has failed in the applicant's or recipient's challenge of any action or inaction of the Secretary under Health-General Article, §7-406, Annotated Code of Maryland, and the enforcement of the final decision has not been stayed pursuant to State Government Article, §10-215. B. When a request for a hearing has been made and the appellant is asking that the Secretary take certain action, the requested action need not be implemented unless the appellant is successful in the appellant's challenge under Health-General Article, §7-406. #### Regulation .07 Secretary's Designee. *COMAR 10.22.16.07* A. The Director shall, in response to a request for a hearing, choose an employee of the Department to conduct the hearing and issue an administrative decision. B. An individual may not serve as the Secretary's designee if, as to this hearing, the individual: (1) Was involved in policy or decision-making regarding the particular action or inaction of the Secretary which is the subject of the hearing; (2) Has a personal financial interest in the matter; or (3) Is related by blood or marriage to the appellant or to the Department's representative. C. The appellant shall be informed before the hearing of the identity of the Secretary's designee, and shall have the right to object based on factors noted in §B of this regulation. #### Regulation .08 Powers and Duties of Secretary's Designee. *COMAR 10.22.16.08* A. The Secretary's designee shall have authority to: (1) Engage in reasonable efforts to secure the attendance of witnesses; (2) Conduct a full, fair, and impartial hearing; (3) Take action to avoid unnecessary delay and duplication in the proceedings; and (4) Maintain order. B. The Secretary's designee: (1) Shall rule on the admissibility of any documentary evidence and on the appearance and testimony of any witness; (2) May question any party or witness; and (3) Shall permit examination of witnesses. #### Regulation .09 Prehearing. *COMAR 10.22.16.09* A. The appellant and the Department's representative are encouraged to engage in informal discussions before the hearing for the purpose of sharing documentary evidence, clarifying facts, resolving issues, and making recommendations to the Secretary's designee regarding areas of agreement and disagreement and the conduct of the hearing. The appellant shall immediately notify the Secretary's designee if and when there has been a resolution of the appellant's concern which results in the appellant withdrawing the request for a hearing. B. Written communications and substantive verbal communications between a party and the Secretary's designee shall be shared with all other parties before the hearing or, if not possible, at the hearing. C. All parties shall make reasonable efforts to comply with the request of other parties to: (1) Preview relevant records and other written material and to permit discussions with relevant persons before the hearing; (2) Introduce into evidence at the hearing relevant records and other written material, and secure the appearance and cooperation of relevant witnesses, including the applicant or recipient. #### Regulation .10 Hearing Procedure. *COMAR 10.22.16.10* A. The appellant shall have the right to request that the hearing be closed to the public. The Secretary's designee shall grant the appellant's request for a closed hearing if the Secretary's designee, after hearing from the parties, determines that the appellant's interest in confidentiality and privacy outweighs the value to the public of an open hearing. B. The Secretary's designee shall call the case to order and explain the issue or issues to be decided and the hearing procedure. C. The appellant shall present the reasons the appellant objects to the Secretary's actions or inactions and the appellant's argument for the relief requested. D. All parties shall have the opportunity to present evidence, call witnesses, and question the other party's witnesses. E. In order to clarify relevant facts, the Secretary's designee may question any person at any time during the hearing. F. With the consent of both parties, the Secretary's designee may allow discussion of the issues among the parties and relevant witnesses in order to seek resolution. G. The applicant or recipient and that person's representative or representatives shall have the right to testify at the hearing. H. The Secretary's designee may, with consent of the parties, conduct all or part of a hearing by telephone if each party in the hearing has an opportunity to participate in and hear the entire proceeding while it is taking place. #### Regulation .11 Burden of Persuasion. *COMAR 10.22.16.11* The appellant bears the burden of persuasion and may not prevail unless the appellant convinces the Secretary's designee by a preponderance of the evidence that the Secretary's action or inaction was incorrect. #### Regulation .12 The Record. *COMAR 10.22.16.12* The Secretary's designee shall: A. Maintain the official record of the hearing; B. Include in the official record of the hearing: (1) Official correspondence regarding the hearing, including the request for the hearing and the Secretary's response, (2) Written material submitted by the parties, (3) Evidence admitted by the Secretary's designee, (4) A tape recording of the hearing, and (5) The decision of the Secretary's designee. #### Regulation .13 Decision of the Secretary's Designee. *COMAR 10.22.16.13* A. The Secretary's designee shall decide a case within 14 days of the hearing based upon the entire record in the case and according to the burden of persuasion set forth in Regulation .11. The Secretary's designee may communicate with the parties for the purpose of developing a decision agreeable to all parties provided the Secretary's designee complies with Regulation .09B. B. The Secretary's designee shall prepare a written decision which includes the following statements: (1) The issues presented for resolution; (2) Whether the appellant met the burden of persuasion as to each issue; (3) To what extent, if any, the relief requested by the appellant is being granted; (4) What, if any, action the Department is required to take and when the action shall occur; and (5) The appellant's right to appeal the decision of the Secretary's designee pursuant to Health-General Article, §7-406, Annotated Code of Maryland, if the relief requested was not granted. C. The Secretary's designee shall promptly deliver or mail copies of the final decision to all parties. ### Chapter 17 — Fee Payment System for Licensed Residential and Day Programs **Authority:** Health-General Article, §§2-104(b), 7-306.1, 7-307, 7-910(c), 15-105, 15-107, and 16-201, Annotated Code of Maryland **Administrative History:** Effective date: August 10, 1987 (14:16 Md. R. 1775) **Administrative History:** Regulations .01—.03, .06, and .08 amended as an emergency provision effective October 16, 1995 (22:22 Md. R. 1654) **Administrative History:** Regulation .01B amended effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .02A amended effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .02F repealed effective June 21, 1993 (20:12 Md. R. 997) **Administrative History:** Regulation .03D amended effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .06 amended effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .08C adopted effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .08D adopted as an emergency provision effective July 11, 1996 (23:16 Md. R. 1167); emergency status extended at 24:2 Md. R. 113; emergency status expired June 30, 1997 **Administrative History:** Chapter repealed and new chapter adopted effective July 1, 1998 (25:13 Md. R. 993) **Administrative History:** Regulation .02B amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839) **Administrative History:** Regulation .03C adopted as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839) **Administrative History:** Regulation .06G amended as an emergency provision effective June 29, 1999 (26:15 Md. R. 1145); amended permanently effective October 4, 1999 (26:20 Md. R. 1545) **Administrative History:** Regulation .06G amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); amended permanently effective October 16, 2000 (27:20 Md. R. 1839) **Administrative History:** Chapter revised as an emergency provision effective July 1, 2001 (28:15 Md. R. 1394); revised permanently effective December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .01A amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332) **Administrative History:** Regulation .02B amended as an emergency provision effective July 1, 2002 (29:14 Md. R. 1073); amended permanently effective September 30, 2002 (29:19 Md. R. 1524) **Administrative History:** Regulation .02B amended effective March 13, 2006 (33:5 Md. R. 520); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .02B amended as an emergency provision effective August 12, 2021 (48:19 Md. R. 798); emergency status expired December 31, 2021 **Administrative History:** Regulation .02B amended as an emergency provision effective January 20, 2022 (49:4 Md. R. 296); emergency status expired effective March 31, 2022 **Administrative History:** Regulation .02B amended as an emergency provision effective May 27, 2022 (49:13 Md. R. 686); emergency status expired effective June 30, 2022 **Administrative History:** Regulation .02B amended as an emergency provision effective February 2, 2023 (50:4 Md. R. 120); emergency status expired effective August 1, 2023 **Administrative History:** Regulation .03C amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .03C amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332) **Administrative History:** Regulation .03C amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671) **Administrative History:** Regulation .05 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .05A amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332) **Administrative History:** Regulation .06G repealed and new regulation.06G adopted as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); adopted permanently effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .06G amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332) **Administrative History:** Regulation .06G amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .07 amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332) **Administrative History:** Regulation .07 amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .08J amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .08J amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1332) **Administrative History:** Regulation .08J amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); January 1, 2007 (33:26 Md. R. 1997); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:3 Md. R. 491); May 30, 2011 (38:11 Md. R. 671); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); January 2, 2017 (43:26 Md. R. 1445); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .10 amended as an emergency provision effective August 12, 2021 (48:19 Md. R. 798); emergency status expired December 31, 2021 **Administrative History:** Regulation .10 amended as an emergency provision effective January 20, 2022 (49:4 Md. R. 296); emergency status expired effective March 31, 2022 **Administrative History:** Regulation .10 amended as an emergency provision effective May 27, 2022 (49:13 Md. R. 686); emergency status expired June 30, 2022 **Administrative History:** Regulation .10 amended as an emergency provision effective February 2, 2023 (50:4 Md. R. 120); emergency status expired effective August 1, 2023 **Administrative History:** Regulation .10G amended as an emergency provision effective April 8, 2004 (31:9 Md. R. 711); amended permanently effective August 2, 2004 (31:15 Md. R. 1185) **Administrative History:** Regulation .10G amended effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulations .13 and .14 recodified to be Regulations .14 and .15 respectively, and new Regulation .13 adopted effective March 13, 2006 (33:5 Md. R. 520) #### Regulation .01 Scope. *COMAR 10.22.17.01* A. This chapter establishes the methodology that the Department shall use to reimburse: (1) Licensed residential alternative living units, residential group homes, day habilitation programs, and vocational programs that provide services to individuals with disabilities after June 30, 1998; (2) Supported employment provided by licensed providers of services to individuals after June 30, 2001; (3) Add-on component services for individuals in these programs; and (4) Supplemental services for individuals in these programs. B. Services reimbursed under this chapter are funded by Medicaid funds and, in whole or in part, by State general funds. C. When the reimbursement for a service is based on an established rate under this chapter, the rate is based on the service needs of the individual, an allowance for indirect expenses incurred by providers, and the regional location of the services. D. The Administration may contract for additional services according to the State procurement laws. E. This reimbursement system is subject to the Administration's approved budget appropriation. F. This chapter does not affect any cost settlement or litigation related to funding commenced before July 1, 1998. #### Regulation .02 Definitions. *COMAR 10.22.17.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Add-on component” means one or more units of service, each one of which includes funding for direct service and other nondirect costs not covered by the sum of the provider and individual components. (2) “Administration” means the Developmental Disabilities Administration. (3) “Agreement” means a legal document setting forth the rights and responsibilities of the Administration and the provider under the fee payment system. (4) “Appropriate evaluation” means the assessment of an individual by a qualified developmental disability professional using accepted professional standards to document the presence of a: (a) Developmental disability as defined in Health-General Article, §7-101(e), Annotated Code of Maryland; or (b) Severe, chronic disability that qualifies the individual for support services as defined in Health-General Article, §7-403(c), Annotated Code of Maryland. (5) “Attendance day” means, for: (a) Day habilitation and vocational services, when the individual is present in the program for at least 4 hours a day during a regularly scheduled period of operation, with 6 to 8 hours per day as the service goal, and with Administration approval of fewer than 6 hours per day provided the individual plan indicates this lower level of service is necessary; (b) Residential programs, as of October 1, 2001, when the individual is present for at least 6 hours in the home or spends the night in the home, which is the primary residence for the individual; and (c) Supported employment, when the individual is engaged in supported employment for at least 4 hours a day, with 6 to 8 hours per day as the service goal, and with Administration approval of fewer than 6 hours per day provided the individual plan indicates this lower level of service is necessary. (6) “Copayment” means that portion of the provider's charge for services for which the individual is responsible. (7) “Cost report” means a document on a form approved by the Administration that details a provider's allowable operating expenses for a single fiscal year using prescribed cost centers. (8) “Department” means the Maryland Department of Health. (9) “Day habilitation” means services for individuals with developmental disabilities licensed under COMAR 10.22.07 and for purposes of COMAR 10.09.26 includes prevocational services. (10) “Direct services” means staff services provided directly to the individual. (11) “Existing service” means a service continuously provided to an individual by the same provider beginning on or before June 30, 1998. (12) “Existing supported employment service” means a service provided continuously to an individual by the same provider beginning before July 1, 2001. (13) “Fee payment system” means the system for rate setting and reimbursement for services provided by licensed residential, day habilitation, vocational, and supported employment programs. (14) “Fiscal management services (FMS)” means a person approved by the Administration and designated as an Organized Health Care Delivery System under COMAR 10.22.20 that: (a) Assists individuals and families in managing their funds and paying for services; and (b) Is responsible for submitting financial reports to the individual and Administration. (15) “Funding level” means the total annual amount of money awarded by the Administration under the fee payment system or under a contract for a day habilitation, vocational, or residential program. (16) “Individual” means a person who receives services funded by the Administration from a residential, day habilitation, vocational, or supported employment program. (17) “Individual component” means one of the two parts of the rate that is based on an assessment of an individual's level of need as documented in the approved individual information form. (18) “Individual indicator rating scale” means the instrument, approved by the Administration, to assess an individual's level of need. (19) “Individual information form” means the form, approved by the Administration, used for documenting the results of an assessment using the individual indicator rating scale. (20) “Individual plan (IP)” means the written plan of specific action that is developed and modified by an individual's team. (21) “Individual's team” means: (a) The individual; (b) The individual's proponent; (c) Representatives of the licensee; (d) The resource coordinator; and (e) Others the individual may choose to develop the IP. (22) “New individuals” means those individuals starting service with a new provider. (23) “Personal needs allowance” means the amount per month that a provider must allow an individual to retain from their monthly income for personal needs. (24) “Professional services” means services provided by an individual authorized to perform these services under the Health Occupations Article, Annotated Code of Maryland. (25) “Provider” means a person that is licensed and funded by the Administration to provide services to individuals under COMAR 10.22.08 or 10.22.07. (26) “Provider component” means one of two parts of the rate that reimburses providers for indirect expenses. (27) “Rate” means the reimbursement amount for an attendance day of service. (28) “Regional director” means the designee of the Director of the Administration who is responsible for the administration of services in an assigned area of the State. (29) “Residential program” means services for individuals with developmental disabilities licensed under COMAR 10.22.08. (30) “Self-directed services” means services, as approved by the Administration: (a) That an individual arranges; and (b) For which the individual reimburses the provider. (31) “Service approval” means the Administration's written approval for an individual to receive services from a provider. (32) “Supplemental security income (SSI)” means income paid to the aged, blind, or disabled under Title XVI of the Social Security Act. (33) “Supplemental services” means preauthorized services that directly benefit the individual and are not covered by the rate. (34) “Support broker” means a person employed by individuals and families, who have been determined eligible by the Administration, that helps them: (a) Decide what services and supports are best for them; and (b) Access and manage the chosen services and supports. (35) Supported Employment. (a) “Supported employment” means services licensed under COMAR 10.22.07 when the individual is employed outside of the individual's home. (b) “Supported employment” includes volunteer work when the volunteer work is for job training and preparation. (36) Unit of service means: (a) For day habilitation, vocational and supported employment programs awake direct support services, 1 hour; (b) For residential programs: (i) For awake direct support services, 1hour; (ii) A preauthorized unit of service available to the individual and identified in the approved service funding plan; or (iii) For support services other than awake direct support services, the provider cost multiplied by the number of approved hours and divided by the rate; or (c) For professional services, 1 hour. (37) “Utilization review” means the examination of an individual indicator rating scale to ascertain if the service needs level is appropriate and to verify that the indicated level of service is being provided. (38) “Vocational services” means services provided by a licensed provider under COMAR 10.22.07 that are provided outside of the individual's home and for purposes of COMAR 10.09.26 are part of habilitation services. #### Regulation .03 General. *COMAR 10.22.17.03* A. The provider shall sign an agreement with the Administration. B. The rights of the Administration include but are not limited to the following: (1) Approving the individuals to be served; (2) Performing a utilization review of individual indicator rating scales; and (3) Auditing provider operations. C. Personal Needs Allowance. (1) On January 1, 2009, the Administration set the personal needs allowance at $299 per month for an individual. (2) The Administration may increase this amount annually not to exceed the: (a) Social Security Administration's cost-of-living increase to Supplemental Security Income; or (b) Medically needy income level as set forth in COMAR 10.09.24. (3) The Administration shall notify all licensees whenever any increase to the personal needs allowance takes effect. #### Regulation .04 Licensure Requirements. *COMAR 10.22.17.04* To receive reimbursement under this chapter, a provider shall: A. Be licensed in accordance with Health-General Article, Title 7, Annotated Code of Maryland, and COMAR 10.22.08 or 10.22.07; and B. Comply with COMAR 10.09.26 and all other applicable regulations under COMAR 10.09. #### Regulation .05 Reporting Requirements and Record Keeping. *COMAR 10.22.17.05* A. The provider shall submit an annual cost report not later than 6 months after the end of the State fiscal year that: (1) Documents the provider's actual expenditures for the fiscal year being reported; (2) Is based on the provider's audited financial statement; (3) Includes a worksheet reconciling the cost report to the financial statement; and (4) Contains a certification by an independent certified public accountant, who is not an employee of the licensee or any affiliated organization, for the: (a) Individual copayments collected, and (b) Actual attendance days. B. The provider shall: (1) Maintain a record for each individual that includes but is not limited to the: (a) Results of the individual indicator rating scale, (b) Appropriate evaluation, with approval by the regional director responsible for the individual's service approval, and (c) Individual plan that identifies the individual's service needs, signed and dated by the provider; and (2) Report to the Administration regarding the individual's eligibility for Supplemental Security Income (SSI). C. The provider shall submit an annual wage and benefits survey in a format approved by the Administration by the later of 60 days after: (1) The last day of the pay period for which the data is requested; or (2) Receipt of a request from the Administration for wage survey information. D. The Administration may require a provider to complete other reports and furnish information relating to the provider and the cost of services in formats approved by the Administration. E. For reports and data required under this chapter, the Administration may, with notice, suspend payment of the provider component until the report or data is received. F. For the annual cost report and the annual wage and benefits survey, the Administration may, after notice and an opportunity to be heard, fiscally sanction providers as set forth in Health-General Article, §7-910(c), Annotated Code of Maryland. #### Regulation .06 Determination of Individual Component. *COMAR 10.22.17.06* A. The individual component is for costs the provider incurs in providing direct services to the individual. B. The Administration shall establish an individual component for new and existing services that is based on the: (1) Individual indicator rating scale; and (2) Geographic region in which the service is provided. C. Individuals who have been receiving services from a provider and who are transferring to a different provider shall retain the individual component established by the Administration. D. Except as set forth in §C of this regulation, the following apply: (1) The regional director shall establish a temporary individual component for each service the individual is to receive by taking the average of the individual components for all the individuals served by the provider in the service category; (2) The provider shall forward the individual information form reflecting the results of the individual indicator rating scale assessment to the regional director within 35 days for approval; (3) The Administration shall establish a permanent individual component within 6 months based on the approved individual indicator rating scale assessment; and (4) The permanent individual component shall be retroactive to the date the individual entered service. E. The geographic regions are as follows: (1) Region 1 represents Baltimore City, Baltimore County, Anne Arundel County, Harford County, Howard County, Carroll County, and Queen Anne's County; (2) Region 2 represents Calvert County, Frederick County, Prince George's County, Montgomery County, and Charles County; (3) Region 3 represents St. Mary's County, Garrett County, Caroline County, Dorchester County, Kent County, Somerset County, Talbot County, Wicomico County, and Worcester County; (4) Region 4 represents Allegany County; (5) Region 5 represents Cecil County; and (6) Region 6 represents Washington County. F. For purposes of this regulation, levels 1—5 in supervision/assistance and levels 1—5 in health/medical in §G of this regulation represent levels of services needed by individuals as assessed by the individual indicator rating scale. G. Table of Individual Components Effective July 1, 2019. (1) Residential Programs. (2) Day Programs. (3) Supported Employment Programs. (4) Community Learning Services. (5) Employment Discovery and Customization. #### Regulation .07 Provider Components. *COMAR 10.22.17.07* Effective July 1, 2019 the provider components for all regions are as follows: A. The residential program provider component is $70.91; and B. The day habilitation, vocational, supported employment, community learning services, and employment discovery and customization program provider component is $39.26. #### Regulation .08 Add-On Component. *COMAR 10.22.17.08* A. An add-on component is for: (1) Residential programs; (2) Day habilitation, vocational, and supported employment programs; and (3) Professional services. B. The Administration may preauthorize and approve one or more units of add-on components for additional support: (1) Not to exceed 1 year for individuals whose need for additional support is the result of a temporary condition; or (2) Exceeding 1 year for individuals whose need for additional support is on-going. C. The per-unit amounts have been calculated to cover all costs incidental to providing the service. D. In order to preauthorize and approve one or more units of add-on components for an individual, the Administration shall determine that the: (1) Individual's particular circumstances warrant units of add-on components to implement the IP; and (2) Individual requires more services than the provider can provide with the sum of the provider and individual components. E. Circumstances that warrant units of add-on components include a need for: (1) Additional support for an individual whose individual component is less than level 5 and for whom approval of an add-on component would be more cost effective than an increase in the individual component; (2) Ongoing, intensive support, such as one-to-one support, for an individual whose individual component is level 5; (3) Ongoing support in a residential program for an individual who does not attend day services; (4) Awake-overnight support for an individual; and (5) Professional services not covered by Medicaid or other payers. F. Procedures for Requesting Authorization of Add-On Components. (1) On forms approved by the Administration, the provider shall submit documentation that justifies the request for add-on components. (2) For all requests for add-on components, the justification shall include: (a) Recommendations from the individual's team and appropriate professionals; (b) Services the provider can provide with existing resources; and (c) Any other information required by the Administration. (3) For requests for professional add-on components, additional justification shall include: (a) The individual's IP and any additional documentation the administration requires indicating the service is necessary; and (b) Documentation that: (i) The individual is not eligible for Medical Assistance; (ii) For individuals who are Medicaid eligible, the service sought is not a service covered by the Maryland Medical Assistance Program; or (iii) If the individual is Medicaid eligible and the service is covered by the Maryland Medical Assistance Program, the Maryland Medical Assistance Program has denied coverage, and the agency is pursuing an appeal. G. Administration Approval of Add-on Components. (1) In deciding whether to preauthorize an add-on component, the Administration shall: (a) Consider the documentation submitted by the provider in §F of this regulation that identifies the needs of the individual; (b) Consider the proposed cost for the add-on component; (c) Consider the existing funding levels for other individuals at the service site and the availability of State funds; (d) If appropriate, visit the individual in the setting where the service is to be provided; and (e) Review the provider's efforts to meet the individual's needs with existing resources available at the site such as staffing levels and revenue for all services provided at the site. (2) When determining the number of units of add-on components to authorize, the Administration shall conduct the cost analysis described in §G(1) of this regulation. The Administration may authorize the number of units of add-on components necessary to fund the amount identified by the cost analysis. H. Review of Add-on Components. Unless justification for a less frequent review is documented, the Administration shall review the appropriateness of the add-on component: (1) For individuals receiving temporary additional support, quarterly for up to 1 year after which the Administration shall: (a) Reassess the appropriateness of the individual component and increase the individual component if justified; (b) Continue the temporary additional support for up to 1 year if the individual's prognosis indicates that the condition remains temporary; or (c) Discontinue the temporary additional support; and (2) For other individuals, quarterly during the first year and annually after that. I. The add-on component is calculated by multiplying the number of units of service per week approved by the Administration by the per unit amount and dividing by seven for residential programs and by the number of approved days of service per week for day habilitation, vocational, and supported employment programs. J. Reimbursement for Add-On Components. (1) Unless the Administration preauthorizes an add-on component, the Administration may not reimburse the provider. (2) Effective July 1, 2019, the amount per unit of service for residential programs is as follows: (a) In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $21.19; (b) In Cecil County — $22.31; and (c) In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $22.59. (3) Effective July 1 2019, the amount per unit of service for day habilitation and community learning services is as follows: (a) In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $23.68; (b) In Cecil County — $24.80; and (c) In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $25.09. (4) Effective July 1 2019, the amount per unit of service for supported employment and employment discovery and customization is as follows: (a) In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $23.68; (b) In Cecil County — $24.80; and (c) In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $25.09. (5) Effective July 1 2019, the amount per unit of service per individual for professional services is as follows: (a) In Baltimore City and Allegany, Anne Arundel, Baltimore, Caroline, Carroll, Dorchester, Garrett, Harford, Howard, Kent, Queen Anne's, St. Mary's, Somerset, Talbot, Washington, Wicomico, and Worcester counties — $34.93; (b) In Cecil County — $36.89; and (c) In Calvert, Charles, Frederick, Montgomery, and Prince George's counties — $37.39. #### Regulation .09 Supplemental Services. *COMAR 10.22.17.09* A. The Administration may preauthorize supplemental services. B. Supplemental services do not include any services that are in the State Medical Assistance Plan and can be provided to an individual and reimbursed under the Medical Assistance Program, or any services covered by private insurance or federal and State funded health programs. C. Supplemental services include: (1) Household furnishings and equipment, normally funded once per individual; (2) Transportation equipment and expenses; (3) Assistive technology; (4) Medical equipment; (5) Structural modifications for accessibility; and (6) Other services as preauthorized by the Administration that directly benefit the individual. D. Procedures for Requesting Authorization of Supplemental Services. On forms approved by the Administration, the provider shall submit documentation that justifies the: (1) Request for supplemental services, and includes: (a) Recommendations from the individual's team; (b) Documentation from appropriate individuals; and (c) Any other information required by the Administration; and (2) Basis of the proposed costs, such as: (a) Bids from vendors; (b) Advertisements or invoices from retail or wholesale outlets selling goods and services to the general public; and (c) Rates of a proposed vendor. E. Administration Approval of Supplemental Services. In deciding whether to preauthorize a supplemental service, the Administration shall: (1) Consider the documentation submitted by the provider in §D of this regulation that identifies the needs of the individual; (2) Consider the proposed cost for the supplemental service and the availability of State funds; (3) If appropriate, visit the individual in the setting where the service is to be provided; and (4) Review the provider's efforts to meet the individual's needs with existing resources available at the site. #### Regulation .10 Payment for Services Reimbursed by Rates. *COMAR 10.22.17.10* A. The Department shall pay the provider the rate set forth under this chapter. B. The rate is the sum of the individual component, the provider component, and any add-on component. C. Reimbursement for Attendance Days of Day Habilitation, Vocational Services, and Supported Employment with Fewer than the Hours as Defined in Regulation .02 of this chapter. (1) The Administration may: (a) Not approve reimbursement for an attendance day if the individual receives fewer than 4 hours of service; (b) Approve reimbursement for fewer hours than the normal attendance day if the IP: (i) Documents that the individual is not able to engage in the program activities for the normal attendance day; and (ii) Includes a plan for enabling the individual to be engaged in a normal attendance day; and (c) Approve reimbursement for an attendance day of supported employment when the individual receives fewer than 4 hours of supported employment services if the: (i) IP documents that the individual is not able to engage in supported employment activities for 4 hours a day; (ii) IP includes a plan for enabling the individual to be engaged in supported employment for at least 4 hours with the goal being a normal attendance day; and (iii) Individual is engaged in at least 4 hours of activity that may include day habilitation and vocational services, with the majority of time spent in supported employment. (2) The Administration's approval of electronic or paper attendance documentation as specified by the Administration and submitted by the provider shall constitute approval of an attendance day of fewer than 6 to 8 hours if the approved individual plan indicates this lower level of service is necessary. D. Conversion of Existing Supported Employment Services from a Contract to the Rate System. (1) There is a presumption that the cost of care for existing supported employment services reimbursed by the Administration under the rate system will be the same as under the contract. (2) The Administration shall reimburse the provider at least the same amount for cost of care for existing supported employment services as the Administration reimbursed the provider under the contract. (3) The Administration shall convert the contract reimbursement for individuals into a base rate together, if appropriate, with add-on components. (4) If a utilization review audit indicates that add-on components were not required for the individual, the Administration may recover unnecessary expenditures. (5) A provider may request additional services as set forth in Regulation .08F of this chapter. (6) The Administration shall review any add-on components for existing services every 3 years unless the Administration documents a need for more frequent review. (7) The Department shall reimburse providers of existing supported employment services by converting those contracts to reimbursement under this chapter between June 30, 2001, and July 1, 2002. E. For add-on components, the Department shall reimburse providers of existing augmentation services by converting those contracts to reimbursement under this chapter between June 30, 2001, and July 1, 2003. F. For a single calendar day, the Administration may not reimburse a provider for two or more attendance days of any combination of: (1) Residential services under this chapter, community supported living arrangements under COMAR 10.22.18, and personal care services under COMAR 10.09.20; or (2) Day habilitation services under this chapter, supported employment services under this chapter, vocational services under this chapter, and medical day care services under COMAR 10.09.07. G. Absences and Vacancies. (1) As of July 1, 2011, the Department shall only reimburse providers for 33 days of absences or vacancies per year per individual when the individual is unable to be in residential services due to illness, vacation, home visits, medical appointments, or other circumstances. (2) As of July 1, 2003, the Department may claim federal financial participation for residential absence days as permitted by the Centers for Medicare and Medicaid Services under the Home and Community-Based Waiver. H. The Administration shall reimburse day and supported employment programs an additional $2,000 per year per individual for transportation to and from day habilitation and vocational programs or to and from supported employment for individuals who, because of their disabilities, must use wheelchairs or motorized scooters, if the payments are consistent with the requirements under COMAR 10.09.26 and 10.09.19. I. For residential services only, the Administration shall subtract from the payment, as appropriate, SSI contributions by individuals or other copayments. J. The provider shall: (1) Assist the individual in obtaining SSI, if applicable; and (2) Collect all applicable individual copayment obligations while assuring that the individual retains the personal needs allowance. K. To be reimbursed under this chapter, the provider shall submit: (1) Attendance data for individuals served; and (2) Other information as required by the Administration. #### Regulation .11 Payment For Supplemental Services. *COMAR 10.22.17.11* A. The Administration shall pay the lower of either: (1) Reasonable customary and actual costs not to exceed the cost to the general public; or (2) Medicaid-approved rates. B. Reasonable customary and actual costs are determined and authorized by the Administration before the delivery of the service. C. The Department shall reimburse the providers for preauthorized supplemental services upon submission of an invoice. #### Regulation .12 Contract. *COMAR 10.22.17.12* A. If the Department preauthorizes a professional service, the Administration shall reimburse the provider for professional services according to the rate schedule in Regulation .08J(4) of this chapter except that the Administration may procure services to be reimbursed at a higher rate if: (1) The provider submits documentation that it cannot find a professional to render services at this rate; (2) The usual and customary rate charged by the professional for the service is above the rate in Regulation .08J(4) of this chapter; and (3) The rate that the Maryland Medical Assistance Program reimburses the professional for this service is higher than the rate established by Regulation .08J(4) of this chapter. B. The Administration may procure services needed by an individual as documented in the IP and preauthorized but not covered by rates or supplemental services in accordance with the State's requirements. #### Regulation .13 Rates for Self-Directed Services. *COMAR 10.22.17.13* A. If there is an existing contract to buy vocational and supported employment services, the contract amount less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing supported employment services and support brokerage services in an individual's budget. B. If there is no existing contract to buy vocational and supported employment services, the supported employment rates less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing supported employment services and support brokerage services in an individual's budget. #### Regulation .14 Hearings. *COMAR 10.22.17.14* If an individual is denied services, the individual may request a hearing in accordance with all applicable federal and State laws and regulations, including COMAR 10.09.24. #### Regulation .15 Phase-In of Provider Component. *COMAR 10.22.17.15* A. The Administration shall phase in the provider component for existing services. B. The Administration shall determine providers' increases and decreases as described in this regulation. C. The individual components and the day habilitation and vocational program provider component in Regulations .06 and .07 of this chapter include increases funded by allocations in the fiscal year 1999 budget. The Administration shall calculate the phase-in of provider components before adding these increases to the rate. D. Until the rate reaches the rate in Regulation .07 of this chapter, the phase-in for providers with current provider components higher than that stated in Regulation .07 of this chapter shall be calculated as follows: (1) Each provider's provider component for existing services given after June 30, 1998, shall be adjusted to reflect not more than a 3 percent decrease in the provider's July 1, 1997, funding level; (2) Each provider's provider component for existing services given after June 30, 1999, shall be adjusted to reflect not more than a 7 percent decrease in the provider's July 1, 1997, funding level; (3) Each provider's provider component for existing services given after June 30, 2000, shall be adjusted to reflect not more than a 12 percent decrease in the provider's July 1, 1997, funding level; and (4) Beginning July 1, 2001, the provider component for all existing services is the provider component stated in Regulation .07 of this chapter. E. Until the rate reaches the rate in Regulation .07 of this chapter, the phase-in for providers with current provider components lower than that stated in Regulation .07 of this chapter shall be calculated within the allocated budget for these services as follows: (1) Each provider's provider component for existing services given after June 30, 1998, shall be adjusted to reflect at least a 2.5 percent increase in the provider's July 1, 1997, funding level; (2) Each provider's provider component for existing services given after June 30, 1999, shall be adjusted to reflect at least a 5 percent increase in the provider's July 1, 1997, funding level; (3) Each provider's provider component for existing services given after June 30, 2000, shall be adjusted to reflect at least a 7.5 percent increase in the provider's July 1, 1997, funding level; and (4) Beginning July 1, 2001, the provider component for all existing services is the provider component stated in Regulation .07 of this chapter. F. The provider component for new services or changes in services for any individual after April 30, 1998, is the provider component stated in Regulation .07 of this chapter. ### Chapter 18 — Community Supported Living Arrangements Payment System **Authority:** Health-General Article, §§2-104(b), 7-306.1, 7-307, 7-714, 7-910(c), 15-105, 15-107, and 16-201, Annotated Code of Maryland; Ch. 102, Acts of 2001 **Administrative History:** Effective date: **Administrative History:** Regulations .01—.09 adopted as an emergency provision effective July 1, 2000 (27:15 Md. R. 1397); adopted permanently effective October 30, 2000 (27:21 Md. R. 1976) **Administrative History:** Regulation .02B amended effective March 13, 2006 (33:5 Md. R. 520) **Administrative History:** Regulation .03 amended as an emergency provision effective July 1, 2001 (28:15 Md. R. 1395); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .03 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .03A amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1333) **Administrative History:** Regulation .04 amended as an emergency provision effective July 1, 2001 (28:15 Md. R. 1395); amended permanently effective October 1, 2001 (28:19 Md. R. 1684) **Administrative History:** Regulation .04 amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 14, 2002 (29:20 Md. R. 1588) **Administrative History:** Regulation .04 amended as an emergency provision effective July 1, 2003 (30:14 Md. R. 934); amended permanently effective September 29, 2003 (30:19 Md. R. 1333) **Administrative History:** Regulation .04I, J, K amended effective December 20, 2004 (31:25 Md. R. 1790); March 13, 2006 (33:5 Md. R. 520); December 7, 2006 (33:24 Md. R. 1906); December 31, 2007 (34:26 Md. R. 2263); March 23, 2009 (36:6 Md. R. 491); October 4, 2010 (37:20 Md. R. 1394); April 15, 2013 (40:7 Md. R. 611); July 7, 2014 (41:13 Md. R. 752); October 12, 2015 (42:20 Md. R. 1265); April 9, 2018 (45:7 Md. R. 345); May 20, 2019 (46:10 Md. R. 488); October 5, 2020 (47:20 Md. R. 875) **Administrative History:** Regulation .10 adopted effective March 13, 2006 (33:5 Md. R. 520) #### Regulation .01 Scope. *COMAR 10.22.18.01* A. This chapter establishes the methodology by which the Department shall reimburse licensed Community Supported Living Arrangements providers for: (1) Services, the provision of which begins after June 30, 2000; and (2) Existing services provided under contract which the Department shall convert to this rate system. B. The rates are based on the service needs of the individual and an allowance for indirect expenses incurred by licensees. C. Reimbursement for supplemental services are for services not covered by the rates. D. Services reimbursed by the Community Supported Living Arrangements payment system established by this chapter are paid for by Medicaid funds or, in whole or in part, by State general funds. E. This chapter does not limit the Administration's ability to contract for other services or additional services according to State procurement laws and as set forth in this chapter. F. The Community Supported Living Arrangements payment system is subject to the budget appropriation approved by the General Assembly. G. The Administration pays for the most effective service at the most efficient cost. #### Regulation .02 Definitions. *COMAR 10.22.18.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Actual costs” means all direct and indirect costs that the provider incurs for labor performed or goods delivered. (2) “Administration” means the Developmental Disabilities Administration. (3) “Base services” means services covered by the rate. (4) “Community Supported Living Arrangements (CSLA)” has the meaning stated in COMAR 10.22.01.01B(12). (5) “Department” means the Maryland Department of Health. (6) “Direct services” means services provided directly to the individual. (7) “Existing services” means a service provided continuously to an individual by the same provider beginning on or before June 30, 2000. (8) “Fiscal management services (FMS)” means a person approved by the Administration and designated as an Organized Health Care Delivery System under COMAR 10.22.20 that: (a) Assists individuals and families in managing their funds and paying for services; and (b) Is responsible for submitting financial reports to the individual and Administration. (9) “Hours of service” means the preauthorized hours of direct services made available to the individual being served as identified in the individual plan. (10) “Individual plan (IP)” has the meaning stated in COMAR 10.22.01.01B(27). (11) “Licensee” means a provider of Community Supported Living Arrangement services licensed under COMAR 10.22.02.01A. (12) “New individuals” means those individuals starting Community Supported Living Arrangements services with a licensee after June 30, 2000. (13) Professional Services. (a) “Professional services” means services provided by an individual authorized to perform these services under Health Occupations Article, Annotated Code of Maryland. (b) “Professional services” includes but is not limited to direct, on- going nursing services and behavioral services provided in accordance with COMAR 10.22.10. (14) “Rate” means the amount the Department pays for an hour of CSLA service and covers all actual costs incidental to providing the service, including but not limited to coordination of the service; nursing review of services; administrative costs; staff hiring, training, travel, and supervision; and program direction. The hours of service are used to determine the rate. (15) “Self-directed services” means services, as approved by the Administration: (a) That an individual arranges; and (b) For which the individual reimburses the provider. (16) “Supplemental services” means preauthorized services not covered by the rate. (17) “Support broker” means a person employed by individuals and families, who have been determined eligible by the Administration, that helps them: (a) Decide what services and supports are best for them; and (b) Access and manage the chosen services and supports. #### Regulation .03 General Requirements. *COMAR 10.22.18.03* A. To provide CSLA services and seek reimbursement from the Administration, a licensee shall: (1) Be licensed in accordance with Health-General Article, Title 7, Annotated Code of Maryland, and COMAR 10.22.02; (2) Comply with: (a) COMAR 10.22.08; and (b) COMAR 10.09.26; (3) Execute an agreement with the Administration; (4) Comply with the Administration's reporting and record-keeping requirements, including: (a) Submitting an annual cost report on a form approved by the Administration not later than 6 months after the end of the State fiscal year that: (i) Documents the licensee's actual expenditures for the fiscal year being reported; (ii) Is based on the licensee's audited financial statement; (iii) Includes a work sheet reconciling the cost report to the financial statement; and (iv) Is certified by an independent certified public accountant, who is not an employee of the licensee or any affiliated organization, for the actual days each individual received services; and (b) Retaining documentation of the costs for supplemental services for at least 6 years after the expenses are incurred; and (c) Submitting an annual wage and benefits survey in a format approved by the Administration by the later of 60 days after: (i) The last day of the pay period for which the data is requested; or (ii) Receipt of a request from the Administration for wage survey information. (5) Submit to the Administration for its approval the number of hours of service an individual needs per week, as documented by the individual's IP, on a form specified by the Administration. B. For reports and data required under this chapter, the Administration may, with notice, suspend payment of 25 percent of the provider's per diem rate until the report or data is received. C. For the annual cost report and the annual wage and benefits survey, the Administration may, after notice and an opportunity to be heard, fiscally sanction providers as set forth in Health-General Article, §7-910(c), Annotated Code of Maryland. #### Regulation .04 Rates. *COMAR 10.22.18.04* A. The Department shall reimburse the licensee: (1) For new individuals served after June 30, 2000, according to the rates set forth in this regulation; and (2) For individuals receiving existing services, by converting those contracts to the Community Supported Living Arrangements Payment System if appropriate between: (a) July 1, 2000, and December 31, 2000, if the individuals are living in their own residences, and (b) January 1, 2001, and June 30, 2001, if the individuals are living with their families. B. The Administration determines the rate based on the number of preauthorized hours of service each individual needs each week as documented by the individual's IP. C. If an individual does not need the same amount of services each week, the rate is determined by the number of preauthorized hours of service in a 4-week period divided by 4, and is at least 1 hour each week. D. The Department shall pay a daily amount per individual calculated by multiplying the number of hours of service each week approved for the individual by the hourly rate and dividing by seven. E. The basic rates for CSLA services are set forth in §I of this regulation. These rates do not include professional services. F. Under the rates, the Department may pay for up to 82 hours of service each week. G. If awake-overnight or one-to-one services are indicated in the individual's IP, and are not included in the 82 hours of base rate service, the Administration may: (1) Preauthorize and approve additional hours of service beyond 82 hours after reviewing the IP and any additional documentation the Administration requests; and (2) Reimburse the licensee as set forth in §J of this regulation for these services. H. Professional Services. (1) The Administration may preauthorize and approve professional services if: (a) The individual's IP, and any additional documentation the administration requires indicates the service is necessary; and (b) The provider submits documentation that: (i) The individual is not eligible for medical assistance, (ii) For individuals who are Medicaid eligible, the service sought is not a service covered by the Maryland Medical Assistance Program, or (iii) If the individual is Medicaid eligible and the service is covered by the Maryland Medical Assistance Program, the provider submits documentation that the Maryland Medical Assistance Program has denied coverage, and the agency is pursuing an appeal. (2) If the Administration approves and preauthorizes a professional service, the Administration shall reimburse the provider for professional services according to the rate schedule in §K of this regulation except that the Administration may procure services to be reimbursed at a higher rate if: (a) The provider submits documentation that it cannot find a professional to render services at this rate; (b) The usual and customary rate charged by the professional for the service is above the rate of this regulation; and (c) The rate that the Maryland Medical Assistance Program reimburses the professional for this service is higher than the rate established by §K of this regulation. I. Fiscal Year 2020 Tables for CSLA’s Personal Supports Hourly Rates. (1) State Fiscal Year 2019 CSLA’s Personal Supports Rates: Table for One Individual in a Dwelling Receiving CSLA Services. (2) State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for Two Individuals in a Dwelling Receiving CSLA Services. (3) State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for Three Individuals in a Dwelling Receiving CSLA Services. J. State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for 1:1 Support or Not More than 8 Hours of Awake-Overnight Support per Residence for Individuals Receiving CSLA Services Regardless of the Number of Individuals in a Dwelling. K. State Fiscal Year 2020 CSLA’s Personal Supports Rates: Table for Professional Services for Individuals Receiving CSLA Services Regardless of the Number of Individuals in a Dwelling. #### Regulation .05 Supplemental Services. *COMAR 10.22.18.05* A. Supplemental services do not include any services that are in the Maryland Medical Assistance Program and can be provided to an individual and reimbursed under the Medical Assistance Program, or any services covered by private insurance, including Medicare. B. Supplemental services include: (1) Respite; (2) Expenses related to the operation and maintenance of the individual's vehicle; (3) Medical equipment; (4) Structural modifications for accessibility; (5) Habitation start-up; (6) Assistive technology; (7) Other services as preauthorized and approved by the Administration; and (8) Housing costs, if: (a) The individual is unable to pay the full amount of ongoing housing costs, and (b) There are no other State or federal resources available to pay for the ongoing housing costs. #### Regulation .06 Requests For and Approval of Supplemental Services. *COMAR 10.22.18.06* A. In order for the Administration to reimburse a licensee for supplemental services, the Administration shall preauthorize the service and approve the cost. B. To be approved for reimbursement of supplemental services, except housing, the licensee shall: (1) Submit a written request to the Administration justifying the request, including: (a) Recommendations from the individual's team, (b) Documentation from appropriate professionals, and (c) Other documentation the Administration requires; and (2) Justify the basis of the proposed costs and submit supporting documentation, such as: (a) Bids from vendors, (b) Advertisements for the item, and (c) Rates of a proposed vendor. C. To be approved for reimbursement of supplemental housing costs, the licensee shall submit a written request to the Administration documenting: (1) The individual's income and expenses; (2) The housing costs; and (3) Efforts to obtain other State or federal assistance with housing costs. D. In deciding whether to authorize supplemental services, the Administration shall: (1) Consider the documentation submitted by the provider in this regulation; (2) Consider the proposed cost for the service; (3) If appropriate, visit the individual in the setting where the continuous supplemental services are to be provided; and (4) Review the licensee's efforts to meet the individual's needs within existing resources. #### Regulation .07 Payment for Base Services. *COMAR 10.22.18.07* The licensee shall submit invoices or electronic claims in the form determined by the Administration. #### Regulation .08 Payment For Supplemental Services. *COMAR 10.22.18.08* A. The Administration shall pay the lower of either: (1) Reasonable customary and actual costs not to exceed the cost to the general public; or (2) Medicaid-approved rates. B. Reasonable customary and actual costs are determined and authorized by the Administration before the delivery of the service. C. The Department shall reimburse the licensee for preauthorized supplemental services upon submission of an invoice. #### Regulation .09 Contract. *COMAR 10.22.18.09* The Administration shall contract for services needed by an individual as documented in the IP and preauthorized but not covered by rates or supplemental services in accordance with the State's procurement requirements. #### Regulation .10 Rates for Self-Directed Services. *COMAR 10.22.18.10* A. If there is an existing contract for family support services or individual support services, the contract amount less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing support services and support brokerage services in an individual's budget. B. If there is no existing contract for family support services or individual support services, the CSLA rates less the amount to be paid for fiscal management services shall be used in determining the amount of money available for purchasing support services and support brokerage services in an individual's budget. ### Chapter 19 — Special Programs **Authority:** Health-General Article, §§2-104(b), 7-306.1, and 7-904, Annotated Code of Maryland **Administrative History:** Effective date: December 22, 2003 (30:25 Md. R. 1846) #### Regulation .01 Definitions. *COMAR 10.22.19.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Day services” means services provided by a licensed provider under COMAR 10.22.07.03E. (2) “Enclave” means a group of eight or fewer individuals with developmental disabilities that works as a single team in a single community work site. (3) “Fiscal Incentive Program for Employment (FIPE)” means the program that provides a one-time fiscal incentive to eligible programs to assist individuals with developmental disabilities in securing and maintaining a job of the individual's choice in the community. (4) “Mobile crew” means a group of eight or fewer individuals with developmental disabilities that operates as a single team moving from one work site to another, performing contracted tasks such as custodial and ground maintenance. (5) “Self-employed” means an individual who owns and operates a business that generates revenue. (6) “Sheltered environment” means a setting that is segregated to include only individuals with disabilities who perform work or simulated work training activities for subminimum wages. (7) “Supported employment” has the meaning stated in COMAR 10.22.07.03C. #### Regulation .02 Fiscal Incentive Program for Employment. *COMAR 10.22.19.02* A. Provider Eligibility. A provider is eligible to be included in the FIPE if the provider: (1) Is licensed as a vocational or day services program under COMAR 10.22.07; and (2) Provides services to an eligible individual. B. Individual Eligibility. An individual is eligible to be included in the FIPE if the individual: (1) Has a developmental disability; (2) Has not received a day service funded by the Administration before July 1, 2003; (3) Is employed in the same job for 6 months which commenced on or after July 1, 2003, or if the individual was employed before entering DDA supported employment services, the 6 months of employment at the same job begins on the day in which the individual begins services, which is on or after July 1, 2003; (4) Is receiving ongoing supports and services that are individually determined in order to attain and maintain a job of the individual's choice; and (5) Has not been previously included in the FIPE. C. Employment Eligibility. A job is an eligible job under the FIPE if: (1) The job is: (a) Located in the community; (b) Individualized; (c) Not an enclave, mobile crew, or in a segregated environment; and (d) Based on the individual's interests; and (2) The individual: (a) Is paid a competitive salary and, if available, offered benefits directly by the employer; (b) Does not receive salary and, if available, benefits from the provider or any organization affiliated with the licensee; (c) Deals directly with the employer regarding working conditions such as work schedule; (d) Has the opportunity for increased responsibility, career advancement, and increased wages based on performance; and (e) If self-employed, the business generates revenue. D. Reimbursement. (1) If the provider wishes to seek reimbursement through the FIPE, the provider shall: (a) Complete the application form provided by the Administration; (b) Provide: (i) Pay stubs for the last 6 months showing that an individual was employed in the community, as requested by the Administration; or (ii) If the individual is self-employed, cash flow or other financial statements for the last 6 months; (c) Provide evidence that ongoing supports and services that are individually determined in order to maintain the job of the individual's choice have been provided; (d) Provide a written statement from the individual or the individual's proponent indicating that the individual is satisfied with the current job and working conditions, including pay, work schedule, and benefits; and (e) Provide any other information required by the Administration. E. Administration Approval. In deciding whether to authorize an individual for inclusion in the FIPE, the Administration shall consider the: (1) Application and supporting documentation; and (2) Availability of State funds. F. Payment. (1) For each preauthorized and eligible individual, the Administration may approve a payment to the provider in the amount of 10 percent of the individual's annual funding, excluding add-on components and supplemental services, for the year the individual entered the FIPE. (2) The Administration shall approve only one payment for each preauthorized and eligible individual. (3) The provider shall submit an invoice to the Administration to receive payment. ### Chapter 20 — Organized Health Care Delivery Systems **Authority:** Health-General Article, §7-904, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .09 adopted as an emergency provision effective June 1, 2004 (31:16 Md. R. 1252); adopted permanently effective September 27, 2004 (31:19 Md. R. 1432) #### Regulation .01 Purpose. *COMAR 10.22.20.01* The purpose of this chapter is to set forth the designation process and requirements for Organized Health Care Delivery Systems (OHCDS). Entities with this designation may subcontract with Medicaid and Non-Medicaid providers to allow individuals to receive services approved in their Individual Plans in the manner which best suits their needs and results in the more complete fulfillment of their plans. #### Regulation .02 Scope. *COMAR 10.22.20.02* This chapter establishes the: A. Methodology that the Department shall use in the designation of entities as Organized Health Care Delivery Systems; and B. Requirements to be fulfilled by Organized Health Care Delivery Systems. #### Regulation .03 Additional Regulatory Compliance. *COMAR 10.22.20.03* In addition to this chapter, a person who becomes an Organized Health Care Delivery System shall comply with the following regulations, as applicable: A. COMAR 10.22.01 — .10; B. COMAR 10.22.17; C. COMAR 10.22.18; and D. COMAR 10.09.26. #### Regulation .04 Definitions. *COMAR 10.22.20.04* A. In addition to the definitions set forth in COMAR 10.22.01, in this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administration” means the Developmental Disabilities Administration. (2) “Organized Health Care Delivery System (OHCDS)” means, under 42 CFR §447.10, a public or private organization for delivering health services that provides at least one Medicaid service directly and utilizes its own employees rather than contractors. (3) “Provider entity” means the OHCDS or potential OHCDS. (4) “Provider of service” means the person who actually delivers the service to the consumer. #### Regulation .05 Designation as an OHCDS. *COMAR 10.22.20.05* The Administration shall designate a provider who applies to be an OHCDS if the provider entity: A. Submits an application on a form approved by the Administration; B. Is licensed by the Administration to provide one of the following services: (1) Community supported living arrangements; (2) Family and individual support services; (3) Day services; (4) Supported employment services; (5) Residential services; and (6) Other services as applicable; C. Is a Medicaid enrolled provider and renders at least one Medicaid Service directly; and D. Meets the requirements of this chapter. #### Regulation .06 OHCDS Requirements. *COMAR 10.22.20.06* An OHCDS may either provide services itself or subcontract with another entity, and shall: A. Ensure that services provided are consistent with the consumer's Individual Plan and are detailed in the payment agreement with the Administration; B. Submit reports and comply with record keeping in accordance with Health-General Article, §§7-306.1 and 7-910, Annotated Code of Maryland; and C. Submit claims for Federal Financial Participation monthly or on an alternative time frame established by the Administration of which 50 percent of the OHCDS' quarterly payment may be withheld if required paperwork is not submitted within the designated time frame. #### Regulation .07 OHCDS Subcontracting Requirements. *COMAR 10.22.20.07* When subcontracting, the OHCDS shall: A. Ensure that the providers of service meet all applicable provider qualifications set forth in COMAR 10.22 and 10.09.26, and any applicable industry or regulatory standards; B. Enter into a subcontract with each provider of service that: (1) Contains the scope, frequency, duration, and cost of the services to be provided; (2) Documents the qualifications of the provider of service; (3) Details service termination procedures; (4) Is consistent with the Individual's Plan; and (5) Is executed by the individual, the service provider, and the OHCDS; and C. Maintain detailed records, to be available to the Administration, its designee, or the respective consumer for review at any time, on the purchase of services from qualified entities or individuals, including invoices. #### Regulation .08 Freedom of Choice of Providers. *COMAR 10.22.20.08* This chapter does not infringe on an individual's right to choose freely among qualified providers at any time. #### Regulation .09 Termination of Designation. *COMAR 10.22.20.09* The Administration may terminate OHCDS designation as set forth in COMAR 10.22.03.06 and 10.22.03.07. ## Subtitle 23 — Advance Directive Registry ### Chapter 01 — Advance Directive Registry **Authority:** Health-General Article, §§5-620 — 5-626, Annotated Code of Maryland **Administrative History:** Effective date: December 6, 2007 (34:24 Md. R. 2158) **Administrative History:** Regulation .05B amended effective August 29, 2016 (43:17 Md. R. 953) **Administrative History:** Regulation .06 repealed effective August 29, 2016 (43:17 Md. R. 953) #### Regulation .01 Scope. *COMAR 10.23.01.01* This chapter defines key terms and sets out requirements and procedures for an Advance Directive Registry. #### Regulation .02 Definitions. *COMAR 10.23.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Advance Directive. (a) “Advance directive” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland. (b) “Advance directive” includes an Instructions on Current Life-Sustaining Treatment Options form developed under Health-General Article, §5-608.1, Annotated Code of Maryland. (2) “Authorized person” means an individual: (a) Designated in writing by a registrant; or (b) Under the conditions specified in federal or State law, authorized to obtain access to the medical records of the registrant. (3) “Department” means the Maryland Department of Health. (4) “Filing” means the presentation of an advance directive for registration to the Secretary. (5) “Health care facility” has the meaning stated in Health-General Article, §19-114, Annotated Code of Maryland. (6) “Health care provider” has the meaning stated in Health-General Article, §5-601, Annotated Code of Maryland. (7) “Instructions on a Current Life-Sustaining Treatment Options form” means the form developed under Health-General Article, §5-608.1, Annotated Code of Maryland. (8) “Registrant” means an individual who registers the individual's advance directive with the Department. (9) “Registry” means the depository for advance directives in the Department. (10) “Secretary” means the Secretary of Health or a designee of the Secretary. #### Regulation .03 Filing and Registration. *COMAR 10.23.01.03* A. An individual may submit an advance directive to the Department for registration. B. In order for the Department to register an advance directive, a registrant shall provide to the Department: (1) A completed application on the form provided by the Department; (2) The required fee, as set forth in Regulation .06 of this chapter; and (3) An advance directive that contains: (a) The registrant's signature; (b) The date on which the advance directive was signed by the registrant; and (c) The signatures of: (i) Two witnesses as provided in Health-General Article, §5-602, Annotated Code of Maryland; or (ii) If an Instructions on a Current Life-Sustaining Treatment Options form is submitted and the registrant is incapable of making an informed decision, the registrant's health care agent or surrogate and the registrant's attending physician. C. On receipt of the items set forth in §B of this regulation, the Department shall: (1) Create a digital reproduction of the form and advance directive; (2) Enter the reproduced form and advance directive into the advance directive database; and (3) Assign each advance directive a file number and password. D. After processing the advance directive presented for registration, the Department shall provide to each registrant: (1) A copy of the registrant's documents on file in the Registry; (2) Instructions for accessing a copy of the registrant's advance directive; (3) Instructions for amending or revoking an advance directive; (4) A wallet card indicating registration of an advance directive; and (5) A sticker to affix to a driver's license or identification card that shows that an advance directive has been filed with the Department. #### Regulation .04 Nonregistration of Advance Directive. *COMAR 10.23.01.04* A. An individual is not required to register an advance directive with the Department. B. An advance directive that is not submitted to the Registry is valid in accordance with applicable law. #### Regulation .05 Amendment or Revocation of a Registered Advance Directive. *COMAR 10.23.01.05* A. The registrant shall notify the Registry if a registered advance directive has been: (1) Amended; or (2) Revoked. B. The Department shall amend the file of a registrant on receipt of: (1) An application for amendment on a form provided by the Department; (2) A copy of the amended advance directive that: (a) Is complete; and (b) Contains all information set forth in Regulation .03B of this chapter. C. A health care provider that becomes aware that a registrant has amended or revoked a registered advance directive shall, at the request of the registrant, provide the registrant with information on how to notify the Registry of the amendment or revocation. D. The Department shall delete the file of a registrant on receipt of: (1) An application for revocation on a form provided by the Department; and (2) Written documentation of revocation as provided in Health-General Article, §5-604, Annotated Code of Maryland. #### Regulation .06 Fees — Repealed. *COMAR 10.23.01.06* #### Regulation .07 Disclosure of Information. *COMAR 10.23.01.07* A. The Department shall provide access to a registered advance directive to: (1) The registrant; or (2) An authorized person. B. To access an advance directive: (1) A registrant or a registrant's designee shall supply the registrant's file number and password; and (2) A representative of a health care facility shall supply the facility's username and password. #### Regulation .08 Storage of Data. *COMAR 10.23.01.08* A. The Department shall establish a Registry that is: (1) Secure, in accordance with data security standards customarily applied to the protection of electronic medical records; and (2) Available 24 hours a day, 7 days a week. B. The Department may provide for services related to the establishment and operation of the Registry through contract with a person or agency. C. The Department or its contractor may store in the Registry only documents that are: (1) Identical to those submitted by the registrant; and (2) In a digital, read-only format preventing modification. D. The Department shall destroy the paper copy of an advance directive submitted by a registrant when the paper copy has been fully and accurately converted to digital copy. #### Regulation .09 Public Outreach. *COMAR 10.23.01.09* The Department shall carry out educational and outreach efforts to increase public awareness of the Registry. #### Regulation .10 Liability of Health Care Providers. *COMAR 10.23.01.10* A health care provider is not subject to criminal prosecution or civil liability and may not be determined to have engaged in unprofessional conduct by the appropriate licensing authority for: A. Failure to access the Registry; or B. Relying on information provided by the Registry. #### Regulation .11 Registry Funding. *COMAR 10.23.01.11* Implementation of this chapter is contingent on the availability of funds, in accordance with State Finance and Procurement Article, §§7-234 and 7-235, Annotated Code of Maryland. ## Subtitle 24 — Maryland Health Care Commission ### Chapter 01 — Procedural Regulations for Health Care Facilities and Services **Authority:** Health-General Article, §§19-109(a)(1) and (8), 19-116(b), 19-118(d), 19-120, 19-120.1, and 19-126, et seq. Annotated Code of Maryland **Administrative History:** Effective date: July 6, 1972 **Administrative History:** Regulations .01 — .16 amended effective February 4, 1976 (3:3 Md. R. 151) **Administrative History:** Regulations .17 and .18 adopted effective February 4, 1976 (3:3 Md. R. 151) **Administrative History:** Chapter revised effective March 24, 1978 (5:6 Md. R. 466) **Administrative History:** Regulations .01B; .02A, B; .05E; .06B, D — G, K; .07A, B, E; .08A, C; .09A; .11A, D; .15A, B; and .17A, B, D amended as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321); adopted permanently effective December 15, 1978 (5:25 Md. R. 1855) **Administrative History:** Regulations .01B; .02A; .06B, F, L; .09D; .11D; .19 amended effective January 25, 1980 (7:2 Md. R. 115) **Administrative History:** Regulation .06B amended as an emergency provision effective February 4, 1981 (8:4 Md. R. 334); emergency status expired June 20, 1981 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .06M adopted as an emergency provision effective July 1, 1978 (5:17 Md. R. 1321); adopted permanently effective December 15, 1978 (5:25 Md. R. 1855) **Administrative History:** Regulations .09E, .11E — G, and .16-1 adopted effective January 25, 1980 (7:2 Md. R. 115) **Administrative History:** Regulation .16F repealed effective January 25, 1980 (7:2 Md. R. 115) **Administrative History:** Chapter revised as an emergency provision effective March 18, 1983 (10:6 Md. R. 536); emergency status extended at 10:17 Md. R. 1520, 10:22 Md. R. 1964, and 11:5 Md. R. 460 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Chapter revised effective April 23, 1984 (11:8 Md. R. 714) **Administrative History:** Regulation .01 amended and recodified as .01-1, and Preface codified as new Regulation .01 effective November 17, 1986 (13:23 Md. R. 2480) **Administrative History:** Regulations .01B, .03D, .07H, and .20B amended as an emergency provision and .03F and .21 adopted as an emergency provision effective August 1, 1985 (12:17 Md. R. 1694); emergency status extended at 12:26 Md. R. 2540; emergency status reapproved effective April 4, 1987 (13:9 Md. R. 1021); emergency status extended at 13:14 Md. R. 1629 and 13:20 Md. R. 2206 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulations .01B, .02A, and .03B amended as an emergency provision and .03F adopted as an emergency provision effective February 28, 1986 (13:6 Md. R. 669) (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulations .01B, .06C, E, .07A — D, F, P, .11, and .23 amended as an emergency provision and .06F adopted as an emergency provision effective March 15, 1986 (13:8 Md. R. 890) (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulations .01-1, .03, .06, .07, and .11 amended as an emergency provision effective July 16, 1987 (14:16 Md. R. 1767); emergency status extended at 14:18 Md. R. 1962 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulations .01-1, .03, .06, .07, .11 and .23 amended as an emergency provision effective September 23, 1987 (14:21 Md. R. 2217); adopted permanently effective February 8, 1988 (15:3 Md. R. 304) **Administrative History:** Regulations .01-1, .03, .06, .07, .09, .11, .15 — .18, and .20 amended as an emergency provision effective March 9, 1989 (16:7 Md. R. 802); emergency status extended at 16:20 Md. R. 2178 and 17:3 Md. R. 295 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .01-1 amended effective February 13, 1995 (22:3 Md. R. 154) **Administrative History:** Regulation .01-1B amended effective April 6, 1987 (14:7 Md. R. 831); October 30, 1989 (16:21 Md. R. 2262); March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .02A — C amended effective November 17, 1986 (13:23 Md. R. 2480); March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .02D amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .03 amended effective November 17, 1986 (13:23 Md. R. 2480); March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .03G — I amended effective February 13, 1995 (22:3 Md. R. 154) **Administrative History:** Regulation .03H adopted effective April 6, 1987 (14:7 Md. R. 831) **Administrative History:** Regulation .03K adopted effective June 13, 1988 (15:12 Md. R. 1447) **Administrative History:** Regulation .03L adopted effective October 30, 1989 (16:21 Md. R. 2262) **Administrative History:** Regulation .06 amended effective November 17, 1986 (13:23 Md. R. 2480) **Administrative History:** Regulation .06C amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .07 amended effective November 17, 1986 (13:23 Md. R. 2480); April 6, 1987 (14:7 Md. R. 831); March 19, 1990 (17:5 Md. R. 638); June 6, 1994 (21:11 Md. R. 951) **Administrative History:** Regulation .08C amended effective November 17, 1986 (13:23 Md. R. 2480); August 3, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .09A amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .11 amended effective November 17, 1986 (13:23 Md. R. 2480) **Administrative History:** Regulation .11C amended effective February 13, 1995 (22:3 Md. R. 154) **Administrative History:** Regulation .11E amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .15 amended effective March 19, 1990 (17:5 Md. R. 638); October 10, 1994 (21:20 Md. R. 1732) **Administrative History:** Regulation .16E amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .17A amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .18 amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .20A amended effective March 19, 1990 (17:5 Md. R. 638) **Administrative History:** Regulation .20B amended effective November 17, 1986 (13:23 Md. R. 2480) **Administrative History:** Regulation .21 amended effective November 17, 1986 (13:23 Md. R. 2480) **Administrative History:** Regulation .23 amended effective November 17, 1986 (13:23 Md. R. 2480) **Administrative History:** Regulation .23B amended effective April 6, 1987 (14:7 Md. R. 831) **Administrative History:** Regulation .23E, F amended effective February 13, 1995 (22:3 Md. R. 154) **Administrative History:** Annotation: COMAR 10.24.01.06 cited in Doctors' Hospital v. Health Resources Planning Commission, 65 Md. App. 656 (1986) **Administrative History:** Annotation: COMAR 10.24.01.07 cited in Sinai Hospital v. Health Resources Planning Commission, 306 Md. 472 (1986) **Administrative History:** Annotation: COMAR 10.24.01.07 cited in Perini Services Inc. v. Health Resources Planning Commission, 67 Md. App. 189 (1986) **Administrative History:** Regulations .01 — .23 repealed and new Regulations .01 — .22 adopted effective November 6, 1995 (22:22 Md. R. 1658) **Administrative History:** Regulation .01B amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379) **Administrative History:** Regulation .01B amended effective August 21, 2000 (27:16 Md. R. 1523); February 5, 2001 (28:2 Md. R. 100); November 24, 2003 (30:23 Md. R. 1652); April 11, 2005 (32:7 Md. R. 680); October 23, 2006 (33:21 Md. R. 1675); April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .01B amended as an emergency provision effective January 23, 2009 (36:4 Md. R. 345); amended permanently effective April 20, 2009 (36:8 Md. R. 595) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective August 21, 2000 (27:16 Md. R. 1523) **Administrative History:** Regulation .02 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .02A amended effective February 5, 2001 (28:2 Md. R. 100) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective August 21, 2000 (27:16 Md. R. 1523) **Administrative History:** Regulation .03 amended effective August 21, 2000 (27:16 Md. R. 1523); April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .03A amended effective November 24, 2003 (30:23 Md. R. 1652) **Administrative History:** Regulation .03B, J amended effective October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .03I amended effective April 10, 2006 (33:7 Md. R. 672) **Administrative History:** Regulation .03K amended effective April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted effective August 21, 2000 (27:16 Md. R. 1523) **Administrative History:** Regulation .04 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .05 repealed and new Regulation .05 adopted effective April 6, 1998 (25:7 Md. R. 527) **Administrative History:** Regulation .05 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .07 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .08 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .08C, E amended effective April 10, 2006 (33:7 Md. R. 672) **Administrative History:** Regulation .08D, F amended effective April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .08E, G amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379) **Administrative History:** Regulation .09 amended effective April 11, 2005 (32:7 Md. R. 680); April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .09A amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379) **Administrative History:** Regulation .09A amended effective April 10, 2006 (33:7 Md. R. 672) **Administrative History:** Regulation .09C amended effective November 24, 2003 (30:23 Md. R. 1652) **Administrative History:** Regulation .09D amended effective April 10, 2006 (33:7 Md. R. 672) **Administrative History:** Regulation .10 amended as an emergency provision effective November 9, 1995 (22:24 Md. R. 1874); amended permanently effective March 11, 1996 (23:5 Md. R. 379) **Administrative History:** Regulation .10 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .11 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .12 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .12C amended effective November 24, 2003 (30:23 Md. R. 1652); April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .13 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .13B amended effective May 5, 1997 (24:9 Md. R. 657) **Administrative History:** Regulation .14 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .15 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .16 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .17 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .18 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .19 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .20 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulation .20E amended effective April 9, 2007 (34:7 Md. R. 699) **Administrative History:** Regulation .22 amended effective April 11, 2005 (32:7 Md. R. 680) **Administrative History:** Regulations .01—.22 under Certificate of Need for Health Care Facilities repealed and new Regulations .01—.22 under Procedural Regulations for Health Care Facilities and Services adopted effective December 1, 2023 (50:22 Md. R. 975) **Administrative History:** Regulation .01B amended effective February 17, 2025 (52:3 Md. R. 159) **Administrative History:** Regulation .03 mended effective February 17, 2025 (52:3 Md. R. 159) **Administrative History:** Regulation .12 amended effective July 22, 2024 (51:14 Md. R. 678) **Administrative History:** Regulation .12E amended effective February 17, 2025 (52:3 Md. R. 159) **Administrative History:** Regulation .21 adopted effective February 17, 2025 (52:3 Md. R. 159) **Administrative History:** Regulation .21 recodified to be Regulation .22 effective February 17, 2025 (52:3 Md. R. 159) **Administrative History:** Regulation .22 recodified to be Regulation .23 effective February 17, 2025 (52:3 Md. R. 159) #### Regulation .01 Definitions. *COMAR 10.24.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Acquisition” means: (a) Any transfer of stock or assets that results in a change of the person or persons who control a health care facility; or (b) The transfer of any stock or ownership interest in excess of 25 percent. (2) “Adversely affected”, for purposes of determining interested party status in a Certificate of Need review, as defined in §B(35) of this regulation, means that a person: (a) Is authorized to provide the same service as the applicant, in the same planning region, or contiguous planning region if the proposed new facility or service could reasonably provide services to residents in the contiguous area, and can demonstrate that the approval of the application: (i) Would materially affect the quality of care at a health care facility that the person operates, such as by causing a reduction in the volume of services when volume is linked to maintaining quality of care; or (ii) Would result in a substantial depletion of essential personnel or other resources at a health care facility that the person operates; or (b) Can demonstrate to the reviewer that a health care facility operated by the person could suffer a potentially detrimental impact from the approval of a project before the Commission, in an issue area over which the Commission has jurisdiction, such that the reviewer, in the reviewer's sole discretion, determines that the person should be qualified as an interested party in the review. (3) “Aggrieved party” means: (a) An applicant or interested party who has submitted written exceptions to a proposed decision to the Commission and would be adversely affected by the final decision of the Commission; or (b) The Secretary. (4) Ambulatory Surgery Center. (a) “Ambulatory surgery center” or “ASC” means any center, service, office, facility, or office of one or more health care practitioners, a group practice, or a non-rate-regulated center owned by a hospital that: (i) Has no more than two operating rooms; (ii) Operates primarily for the purpose of providing surgical services to patients who do not require overnight hospitalization; and (iii) Seeks reimbursement from payors for the provision of ambulatory surgical services. (b) “Ambulatory surgery center” or “ASC” includes the following subcategories: (i) An ASC-P, which has only procedure rooms; (ii) An ASC-1, which has one operating room; and (iii) An ASC-2, which has two operating rooms. (5) “Ambulatory surgical facility” means any center, service, office, facility, or office of one or more health care practitioners or a group practice that: (a) Has three or more operating rooms; (b) Operates primarily for the purpose of providing surgical services to patients who do not require overnight hospitalization; and (c) Seeks reimbursement from a third-party payor as an ambulatory surgical facility. (6) “Approved bed” means a bed approved by the Commission in a Certificate of Need, but not yet licensed. (7) “Bed capacity” or “physical bed capacity” means the total number of beds that a health care facility can set up and staff in space designed for and licensable for use by patients requiring an overnight stay at the facility. (8) “By or on behalf of” includes a capital expenditure that affects the physical plant, service volume, or service capacity of a health care facility or health maintenance organization regardless of the source of the funds. (9) “Capital expenditure” means: (a) An expenditure, including predevelopment costs, which: (i) Is made as part of an acquisition, improvement, expansion, or physical plant replacement; (ii) Results in a change or relocation that would require a CON under Regulation .02A(2)—(4) of this chapter; and (iii) Is made by or on behalf of a health care facility that under generally accepted accounting principles is not properly chargeable as an expense of operation and maintenance or is made to obtain any physical plant for a facility by lease or comparable arrangement; (b) A donation of a physical plant to a health care facility, if a Certificate of Need would be required for an expenditure by the health care facility to acquire the physical plant directly; or (c) A transfer of a physical plant to a facility for less than fair market value, if the transfer of the physical plant at fair market value would be a capital expenditure. (10) “Center for Health Care Facilities Planning and Development” means that center in the Commission that acts as the entry and information point for applications for Certificate of Need, requests for an exemption from Certificate of Need review, or other health care facility-related matters requiring action by the Commission, or its staff, as provided in this chapter. (11) “Certificate of Conformance” means an approval issued by the Commission under Health-General Article, §19-120.1, Annotated Code of Maryland, that allows an acute general hospital to establish emergency percutaneous coronary intervention (PCI) services or elective PCI services without a Certificate of Need. (12) “Certificate of Need” or “CON” means a certification of public need issued by the Commission under Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. (13) “Certificate of Ongoing Performance” means an approval issued by the Commission that the cardiac surgery services, emergency PCI services, or elective PCI services provided by an acute general hospital meet standards evidencing continued quality under Health-General Article, §19-120.1, Annotated Code of Maryland. (14) “Commission” means the Maryland Health Care Commission. (15) “Comparable” when used to determine whether two or more CON applications are subject to comparative review means that the proposed projects are in the same health planning region and involve the addition or expansion of at least one of the same medical services. (16) “Comparative review” means a review in which two or more comparable CON applications are reviewed together and ranked based on each application’s satisfaction of the CON review criteria because the most recently published need projections do not support the implementation of all comparable projects. (17) “Comprehensive care facility” means a nursing home as defined under Health-General Article, §19-1401, Annotated Code of Maryland. (18) “CON-approved service” means any health care service for which a CON was obtained, including: (a) Medical services; (b) Cardiac surgery services; (c) Organ transplant services; (d) Burn treatment services; and (e) Neonatal intensive care services. (19) “Consolidation” means the reconfiguration of two or more health care facilities within a merged asset system such that: (a) The health care facilities in the merged asset system are combined and the total number of health care facilities of the merged asset system is reduced; or (b) The medical services or bed capacity are reallocated among two or more health care facilities of the merged asset system. (20) “Contested review” means a review in which a person has been recognized as an interested party. (21) “Department” means the Maryland Department of Health. (22) “Determination of coverage” means the written determination in accordance with Regulation .14A of this chapter whether CON or other Commission review is required for a project. (23) “Executive Director” means the person appointed chief administrative officer of the Commission in accordance with Health-General Article, §19-106, Annotated Code of Maryland. (24) “Existing health care facility” means a health care facility that is licensed by the Department. (25) “Freestanding medical facility” has the meaning stated in Health-General Article, §19-3A-01, Annotated Code of Maryland. (26) “General hospice care program” has the meaning stated in Health-General Article, §l9-901, Annotated Code of Maryland. (27) Health Care Facility. (a) “Health care facility” means: (i) A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (ii) A limited service hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (iii) A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (iv) An ambulatory surgical facility; (v) An inpatient facility that is organized primarily to help in the rehabilitation of disabled individuals, through an integrated program of medical and other services provided under competent professional supervision; (vi) A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland; (vii) A hospice, as defined in Health-General Article, §19-901, Annotated Code of Maryland; (viii) A freestanding medical facility, as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland; (ix) A comprehensive care facility, except as provided by Regulation .03 of this chapter and Health-General Article, §19-114(d)(2), Annotated Code of Maryland; and (x) Other health institutions, services, or programs that may be specified as requiring a CON under State law. (b) “Health care facility” does not mean: (i) A hospital or related institution operated, or listed and certified, by the First Church of Christ Scientist, Boston, Massachusetts; (ii) A kidney disease treatment facility, or the kidney disease treatment stations and services provided by or on behalf of a hospital, if the facility or the services do not include kidney transplant services or programs; or (iii) The office of one or more individuals licensed to practice dentistry under Health Occupations Article, Title 4, Annotated Code of Maryland, for the purposes of practicing dentistry. (28) “Health care project” means a health care project requiring a Certificate of Need as set forth in Regulation .02 of this chapter. (29) “Health care services” means clinically-related patient services, including medical services. (30) “Health maintenance organization” or “HMO” means a health maintenance organization under Health-General Article, §19-701, Annotated Code of Maryland. (31) “Health planning region” means the area used for regulation of a particular service as provided in the State Health Plan. (32) “Holder” means the applicant or applicants to whom the Commission awarded a Certificate of Need, an exemption from Certificate of Need, or other Commission approval for a project that has not received first use approval or, if necessary, a license from the Department for that project. (33) Home Health Agency. (a) “Home health agency” has the meaning stated in Health-General Article, §19-401(b), Annotated Code of Maryland. (b) “Home health agency” includes a parent home health agency, as defined by the Centers for Medicare and Medicaid Services under 42 CFR §484.2. (34) “Hospital capital threshold” has the meaning stated in Health-General Article, §19-120(a)(4), Annotated Code of Maryland. (35) “Initiation of construction” means: (a) For a new health care facility or expansion of an existing health care facility, that an approved project has: (i) Obtained all permits and approvals considered necessary by applicable federal, State, and local authorities to initiate construction; (ii) Completed all necessary preconstruction site work; and (iii) Started the installation of the foundation system with placement of permanent components such as reinforcing steel, concrete, and piles; and (b) For the renovation of an existing health care facility, that an approved project has: (i) Obtained all permits and approvals considered necessary by applicable federal, State, and local authorities to initiate renovation; and (ii) Started the demolition or relocation of affected services necessary to undertake the renovation project. (36) “Interested party” means a person recognized by a reviewer as an interested party, including: (a) Any applicant who has submitted a competing application in a comparative review; (b) The staff of the Commission; (c) A local health department in the jurisdiction or, in the case of regional services, in the planning region, in which the proposed facility or service is to be offered; (d) In the review of a replacement acute general hospital project proposed by or on behalf of a regional health system that serves multiple contiguous jurisdictions, a jurisdiction within the region served by the regional health system that does not contain the proposed replacement acute general hospital project; and (e) A person who has demonstrated to the reviewer that it meets the definition of adversely affected by the approval of a proposed project. (37) “Intermediate care” means: (a) A planned regimen of 24-hour professional directed evaluation, observation, medical monitoring, and addiction treatment in an inpatient setting for individuals with substance abuse disorder, including American Society of Addiction Medicine (ASAM) Level 3.7 medically monitored intensive inpatient services; and (b) Residential care, treatment, or custody of individuals with intellectual disability or persons with related conditions. (38) “Jurisdiction” means the 23 counties of Maryland and Baltimore City. (39) Licensed Bed Capacity. (a) “Licensed bed capacity” means the number of health care facility beds in any of the medical service categories or subcategories, as they appear in the Commission's inventories of licensed service capacity. (b) “Licensed bed capacity” for acute general hospitals: (i) Means the capacity authorized by the Secretary under Health-General Article, §19-307.2, Annotated Code of Maryland; (ii) Does not mean the number of holding beds to support hospital emergency services, bassinets, beds dedicated to observation of patients, an outpatient service, or recovery beds to support ambulatory surgical services. (40) “Limited service hospital” means a health care facility that: (a) Is licensed as a hospital; (b) Changes the type or scope of health care services offered by eliminating the facility's capability to admit or retain patients for overnight hospitalization; (c) Retains an emergency or urgent care center; and (d) Complies with the regulations adopted by the Secretary under Health-General Article, §19-307.1, Annotated Code of Maryland. (41) “Local health department” means the health department in a jurisdiction or a body designated by that jurisdiction to perform health planning functions. (42) “Long-term significant relationship” means a relationship characterized by mutual economic dependence, demonstrated by evidence such as a joint lease or mortgage or power of attorney, and evidence of common legal residence shown by driver's licenses, voter registration, or other identification. (43) “Maryland Health Care Commission” means the agency established by Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. (44) “Medical service” means: (a) Any of the following categories of health care services as they appear in the Commission's inventories of service capacity: (i) Medical/surgical/gynecological/addictions; (ii) Obstetrics; (iii) Pediatrics; (iv) Psychiatry; (v) Rehabilitation; (vi) Chronic care; (vii) Comprehensive care; (viii) Extended care; (ix) Intermediate care; or (x) Residential treatment center care; or (b) A subcategory of the rehabilitation, psychiatry, comprehensive care, or intermediate care categories of medical services for which the State Health Plan provides a need projection methodology or specific standards. (45) “Merged asset system” means an organization comprised of two or more regulated health care facilities under common ownership or control. (46) “Merger” means the union of two or more health care facilities by the transfer of all the property of one or more of them to one of them, which continues in existence, the others being merged therein. (47) “Multiphased plan of construction” means a plan of construction for an addition, replacement, modernization, relocation, or conversion of an existing health care facility that involves distinct elements of construction, demolition, or renovation that require sequential implementation such that one element can be initiated before subsequent elements of the overall project can be initiated. (48) “Nursing home” has the meaning under Health-General Article, §19-1401, Annotated Code of Maryland. (49) “Operating room” means a sterile room in a surgical suite that meets the requirements of a restricted area and is designated and equipped for performing surgical operations or other invasive procedures that require an aseptic field. (50) “Other Commission approval” means approval of a Certificate of Conformance, Certificate of Ongoing Performance, or an exemption from CON review. (51) “Partial closing” or “partial closure” means the closure or decommission of one or more but not all CON-approved services offered by a health care facility. (52) “Participating entity” means a person recognized by the Executive Director as a participating entity and may include: (a) A third-party payor including: (i) An insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in Maryland; (ii) A health maintenance organization that holds a certificate of authority in Maryland; (iii) A union that is providing a health plan to union members on behalf of an employer in a jurisdiction in which the proposed project will be located or from which an existing health care facility seeks to relocate; (iv) A pharmacy benefit manager; and (v) A self-insured employer offering health benefits through the Employer Retirement Insurance Security Act of 1974; (b) A municipality where the proposed project will be located or from which an existing health care facility seeks to relocate; or (c) In the case of a hospital project, a local health department in a jurisdiction that borders a jurisdiction in which a proposed facility or service will be located. (53) “Person” includes an individual, receiver, trustee, guardian, executor, administrator, fiduciary, or representative of any kind and any partnership, firm, association, limited liability company, limited liability partnership, public or private corporation, or other entity. (54) Personal Physician. (a) “Personal physician” means a physician licensed to practice medicine who: (i) Was chosen by an individual; (ii) Has an established physician-patient relationship with the individual; and (iii) Has provided health care services to the individual. (b) “Personal physician” does not mean an owner of, an employee of, a person under contract with, or a person who has a material financial interest in a continuing care retirement community, its management company, or related entity. (55) Predevelopment Costs. (a) “Predevelopment costs” means all costs related to the preliminary development of a project, which include, but are not limited to, the costs of preliminary plans, studies, surveys, architectural designs, plans, reports, application fees, legal fees, financing fees, consulting fees, working drawings, or specifications undertaken in preparation for the development or offering of a health care project. (b) “Predevelopment costs” does not include activities routinely undertaken by a health care facility as a part of its internal management or long-range planning process. (56) “Primary service area” means: (a) The Maryland postal ZIP code areas from which the first 60 percent of a hospital's patient discharges originate during the most recent 12-month period, where: (i) The discharges from each ZIP code area are ordered from largest to smallest number of discharges; and (ii) Two or more ZIP code areas having the same numbers of discharges are ordered from the largest to smallest based on the percentage of the hospital’s discharges originating from the ZIP code area in the most recent 12-month period; (b) Point ZIP codes physically within any of the ZIP code areas designated in §B(54) of this regulation; (c) Maryland ZIP code areas physically contiguous to any of the ZIP codes designated in §B(54) of this regulation that provided 50 percent or more of their discharges to the hospital in the most recent 12-month period; and (d) For a merged asset system, the ZIP code areas that are tabulated separately for each hospital, and all ZIP code areas identified for each hospital which are included in the primary service area of the merged asset system. (57) Public Obligation. (a) “Public obligation” means a bond, note, evidence of indebtedness, or other obligation to repay borrowed money issued by: (i) The Maryland Health and Higher Educational Facilities Authority; (ii) The State, or any agency, instrumentality, or public corporation of the State; (iii) A governmental entity described in Local Government Article, §19-205(a), Annotated Code of Maryland; (iv) The Mayor and City Council of Baltimore; or (v) A municipal corporation. (b) “Public obligation” does not include an obligation, or portion of an obligation, if: (i) The principal of and interest on the obligation or the portion of the obligation is insured by an effective municipal bond insurance policy and issued on behalf of a hospital that voluntarily closed in accordance with Health-General Article, §19-120(l); and (ii) The proceeds of the obligation or the portion of the obligation are used to finance wholly or partly a facility or part of a facility that is used primarily to provide outpatient services at a location other than the hospital or that is used primarily by physicians who are not employees of the hospital to provide services to nonhospital patients. (58) “Regional health system” means a hospital whose primary or secondary service area cover multiple jurisdictions. (59) “Rehabilitation facility” means an inpatient facility that: (a) Is organized for the primary purpose of assisting in the rehabilitation of persons with disabilities through an integrated program of medical and other services, which are provided under competent professional supervision; (b) Is licensed as a special rehabilitation hospital; and (c) Complies with the regulations adopted by the Secretary under Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland. (60) “Religious order” means an incorporated, not-for-profit organization: (a) That is owned or is wholly operated by an entity founded and operating for the sole purpose of carrying out religious precepts; and (b) Whose members have taken the vows required by the order and have devoted their lives to religious service, to the exclusion of lay life and activities. (61) “Residential treatment center” has the meaning stated in Health-General Article, §19-301(p), Annotated Code of Maryland. (62) “Reviewer” means one Commissioner, appointed by the Executive Director of the Commission, who: (a) Evaluates a Certificate of Need application; (b) Prepares a proposed decision for the consideration of the full Commission; and (c) Serves as presiding officer at an evidentiary hearing on an application or applications, if any. (63) “Secretary” means the Secretary of Health. (64) “Service area” means the geographic area from which a health care facility or provider draws its patients. Unless otherwise specified in a relevant State Health Plan chapter, service area means the zip code areas from which the greatest number of patients reside, which, when ordered from largest to smallest, comprise the top 85 percent of patients who receive a specific service at a health care facility for the most recent 12-month period of data available. (65) “State Health Plan” means the State Health Plan for Facilities and Services and its modifications or additions, adopted by the Commission pursuant to Health-General Article, §19-118, Annotated Code of Maryland. #### Regulation .02 Coverage. *COMAR 10.24.01.02* A. Except as provided in Regulations .03—.05 of this chapter or as otherwise provided by law, a CON is required before: (1) A new health care facility is built, developed, or established; (2) An existing health care facility is moved to another site, unless the relocation is: (a) The result of a partial or complete replacement of an existing hospital or related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland, and is to another part of the site or immediately adjacent to the site of the existing hospital or related institution; (b) Of an existing health care facility owned or controlled by a merged asset system, subject to the provisions of Regulations .03E or .04A(2) of this chapter, whichever is applicable; or (c) By a hospital converting to a limited service hospital, subject to the provisions of Regulation .04A(4) of this chapter, and is to a site within the immediate area, as determined by the Commission, as described in §B of this regulation; (3) The bed capacity of a health care facility is changed; (4) The type or scope of any health care service offered by a health care facility is changed, and the change: (a) Establishes a new medical service; (b) Establishes a new cardiac surgery, organ transplant surgery, burn treatment, or neonatal intensive care program; (c) Establishes a new home health agency, general hospice care program, or ambulatory surgical facility; (d) Builds or expands surgical capacity in a hospital, freestanding medical facility subject to rate regulation by the Health Services Cost Review Commission, or ambulatory surgical facility; (e) Results in: (i) The establishment of a new parent home health agency; or (ii) The expansion of an existing home health agency into a jurisdiction in which it was not previously authorized by the Commission to operate; (f) Eliminates an existing medical service; or (g) Closes an existing health care facility or converts it to a non-health-related use; or (5) A hospital makes a capital expenditure, as defined in Health-General Article, §19-120(k), Annotated Code of Maryland, and in this chapter, that exceeds the hospital capital threshold, including a capital expenditure: (a) For the relocation of an existing health care facility owned or controlled by a merged asset system, except as provided in Regulation .03E of this chapter; and (b) By a relocated health care facility to permit the facility to offer a new health care service for which CON is otherwise required. B. Definition of Immediate Area for Limited Service Hospital Conversion. (1) For the purpose of §A(2)(c) of this regulation, “immediate area” means a location on the site of the existing hospital, or on an adjacent site. (2) A hospital may provide evidence as to why the Commission should approve a site for a limited service hospital beyond the immediate area of the converting hospital. (3) The Commission may not approve a site for a limited service hospital unless the site is within: (a) A 5-mile radius of the site of the hospital proposing the conversion; and (b) Its primary service area. C. A person may not divide a project into component parts except as permitted by this chapter. Commission staff shall issue a determination regarding whether two or more apparently individual projects actually represent component parts of a single project, considering, among other things, the timing of the projects, the functional areas of a facility to be affected, the number of construction contracts entered into, and whether expenditures under one contract depend upon the completion of a prior contract. D. Proposed Change After Acquisition. If a person acquires an existing health care facility or service without a CON, in accordance with Regulation .03 of this chapter, and proposes to change the health care services it provides or its bed capacity, the proposed change requires review and approval in accordance with §A of this regulation. E. A health maintenance organization, or health care facility that either controls, directly or indirectly, or is controlled by an HMO or a group of HMOs, shall obtain a CON before it builds, develops, operates, or participates in building, developing, or operating: (1) A hospital; or (2) Any other health care project for which a CON is required under §A of this regulation, unless at least 90 percent of the patients who will receive health care services from the project will be individuals enrolled in that health maintenance organization. F. If a person is uncertain whether a project requires a Certificate of Need, the person shall request a determination of coverage in accordance with Regulation .14A of this chapter. #### Regulation .03 Non-Coverage by Certificate of Need or Other Commission Approval. *COMAR 10.24.01.03* A. Acquisition of an Existing Health Care Facility. (1) At least 30 days before closing on a contract to acquire a health care facility, the person acquiring the facility shall notify the Commission in writing, with a copy to the local health officer in each affected jurisdiction and the appropriate State licensing agency, of the intent to acquire the facility, and include the following information: (a) The health care services provided by the facility; (b) The bed capacity, or jurisdiction served, if a community-based service; (c) Complete organizational charts that describe the ownership of the health care facility prior to and after the proposed acquisition; (d) A description of any unsatisfied conditions imposed by the Commission on the facility and an affirmation that the person acquiring the facility will abide by any conditions still in effect; and (e) Any other information required by this chapter, by the State Health Plan chapter applicable to the health care facility, or requested by Commission staff. (2) Deemed Approval. (a) Except for acquisitions of a nursing home, CON review is not required if Commission staff does not issue either a determination of coverage or notice that timely or complete notice was not received within 60 days of receipt of a notice from the person acquiring the health care facility. (b) Upon request, Commission staff shall provide written confirmation that an acquisition was deemed approved under this regulation. (3) Commission staff’s determination that CON or other Commission review is not required remains valid for 180 days from its issuance. A new determination of coverage shall be required if the acquisition is not completed within that time period. (4) If the acquisition is completed, the buyer shall sign a notice of completion of acquisition and file it with the Commission within 15 days of the completion of the acquisition. (5) Conditions imposed by the Commission on a health care facility survive an acquisition of the facility. B. Acquisition of a Nursing Home, Home Health Agency, or Hospice. (1) In addition to providing the information required in §A of this regulation, a person seeking to acquire a nursing home shall obtain approval for the acquisition in accordance with Regulation .21 of this chapter. (2) In addition to providing the information required in §A of this regulation, a person seeking to acquire a home health agency or hospice shall: (a) Identify each person with an ownership interest in the acquiring entity or a related or affiliated entity, including (i) The percentage of ownership interest of each such person; and (ii) The history of each such person’s experience in ownership or operation of health care facilities; (b) Provide information on corporate structure and affiliations of the acquirer, purchase price, source of funds, and other relevant data as requested; (c) Affirm that the services provided will not change as a result of the proposed acquisition and that its commitment to Medicaid participation, if any, will not decrease as a result of the proposed acquisition; and (d) Affirm under penalties of perjury, that within the last 10 years no owner or former owner of the purchaser, or member of senior management or management organization, or a current or former owner or senior manager of any related or affiliated entity has been convicted of a felony or crime, or pleaded guilty, nolo contendere, entered a best interest plea of guilty, received a diversionary disposition regarding a felony or crime, and that the purchaser or a related or affiliated entity has not paid a civil penalty in excess of $10 million dollars that relates to the ownership or management of a health care facility. (3) Disqualification for Acquisition. A nursing home, home health agency, or hospice may not be acquired by an entity if an owner or member of senior management or an owner or member of senior management of a related or affiliated entity of the acquiring entity has been convicted of a felony or crime or pleaded guilty, nolo contendere, entered a best interest plea of guilty, or received a diversionary disposition regarding a felony or crime within the last 10 years, unless: (a) All of the individuals involved in the fraud or abuse are no longer associated with the entity or any of its related or affiliated entities; (b) Each entity has fully complied with each applicable plan of correction; and (c) If applicable, each entity has fully complied with each condition of the imposition of a civil penalty or agreed disposition. (4) In an acquisition of a home health agency or hospice, the purchaser may only acquire the authority to provide services in jurisdictions for which the facility being acquired was granted a CON or is otherwise recognized by the Commission as having legal authorization. C. Closure of a Health Care Facility. (1) A CON is not required to close a health care facility or part of a health care facility, including a State hospital, if it provides notice to the Commission at least 90 days prior to the closing or 45 days prior to the partial closing and complies with the provisions of §C(2)—(4) of this regulation, if applicable. (2) An acute general hospital shall hold a public informational hearing in accordance with Regulation .04D of this chapter if the hospital: (a) Files a notice of the proposed closing of the hospital with the Commission; or (b) Is located in a jurisdiction with fewer than three acute general hospitals and files a notice of the partial closing of the hospital. (3) The Commission may require a health care facility not covered by §C(2) of this regulation to hold a public information hearing in accordance with Regulation .04D of this chapter. (4) If a hospital that intends to close has outstanding public obligations issued on its behalf, written notice of its intended closing shall be given to the Maryland Health and Higher Educational Facilities Authority and the Health Services Cost Review Commission by the: (a) Commission, within 5 days after receiving a written notification by the hospital of its intended closure; (b) Hospital, within 10 days of filing with the Commission its written notification of its intended closure, along with a written statement of all public obligations issued on behalf of the hospital that provides the information required by Economic Development Article, §10-346(a)(2), Annotated Code of Maryland; and (c) Commission, that the hospital held a public informational hearing in consultation with the Commission in the jurisdiction where the hospital is located. D. Temporary Delicensure or Suspension of Bed Capacity, Health Care Facility, or CON-Approved Service. (1) A temporary delicensure of licensed bed capacity or a licensed and operating health care facility or a temporary suspension of a CON-approved service does not require CON review, and the Commission will retain the bed capacity or health care facility on its inventory or permit the reimplementation of the CON-approved service without obtaining a CON for up to 1 year, if the owner or licensed operator: (a) Provides written notice to the Commission at least 30 days before the proposed temporary delicensure or temporary service suspension; (b) Identifies good cause for the proposed temporary delicensure or temporary service suspension; (c) States the intention either to bring the bed capacity back onto the facility's license or relicense the health care facility or reimplement the CON-approved service at the end of the 1-year period, or to notify the Commission that it intends to take another of the actions permitted under this subsection; and (d) Has received authorization from the Executive Director for the temporary delicensure or temporary service suspension. (2) Temporary Delicensure of Nursing Home Bed Capacity after an Acquisition. (a) A temporary delicensure of licensed bed capacity or a licensed and operating nursing home following an acquisition does not require CON review, and the Commission will retain the bed capacity or the nursing home on its inventory for up to 3 years immediately following the acquisition, if the person who acquired the nursing home: (i) Provides written notice to the Commission at least 30 days before the proposed temporary delicensure; (ii) Demonstrates the temporary delicensure is needed to reduce the number of resident rooms that contain more than 2 beds; (iii) States the intention either to bring the bed capacity back onto the facility's license or relicense the health care facility at the end of the 3-year period, or to notify the Commission that it intends to take another of the actions permitted under §D of this regulation; and (iv) Has received authorization from the Executive Director for the temporary delicensure. (b) The Executive Director may extend the period of a temporary delicensure under §D of this regulation beyond 3 years for good cause including: (i) Demonstrated progress toward eliminating multi-bedded rooms by expanding the existing facility; (ii) A pending or approved application for a CON or exemption from CON review to relocate the beds to another existing or new facility; (iii) Evidence of physical or legal constraints; or (iv) Evidence of good faith negotiations to sell the beds. (3) Bed capacity or a facility that has been authorized by the Commission to be temporarily delicensed or a CON-approved service that has been authorized by the Commission to be temporarily suspended is not subject to the provisions of this section: (a) During the pendency at the Commission of a letter of intent to apply or an application for CON approval involving the temporarily delicensed bed capacity or facility or the temporarily suspended CON-approved service; (b) If the Commission has issued a Certificate of Need to reimplement the facility's temporarily delicensed bed capacity or the facility’s temporarily suspended CON-approved service; (c) If the Commission has approved a request pursuant to Regulation .03 or .04 of this chapter to reimplement the bed capacity, facility or CON-approved service, and has determined that the bed capacity, facility, or CON-approved service may be reimplemented without a CON or other Commission approval, including but not limited to actions that may be undertaken by a merged asset system of which the facility is a member; (d) If the Commission receives a notice of acquisition of the temporarily delicensed bed capacity or facility and the buyer and seller timely complete the acquisition, in accordance with Regulation .03 of this chapter; or (e) If the Commission receives written notification that the owner or operator of the temporarily delicensed bed capacity or facility has applied for relicensure or reimplementation of the temporarily suspended CON-approved service. (4) The requirements and procedures in this subsection do not apply to: (a) A proposal to close, on either a temporary or a permanent basis: (i) An acute general hospital or part of a hospital, including a medical service, in a jurisdiction with fewer than three acute general hospitals; or (ii) A health care facility that provides any medical service approved by the Commission as a regional or Statewide health resource; or (b) A temporary interruption of a CON-approved service that does not exceed 30 days. (5) This section does not substitute any notice or approvals that may be required from another body that regulates the bed capacity, health care facility, or CON-approved service. (6) A health care facility may not request authorization by the Commission to temporarily delicense bed capacity or the entire health care facility or to temporarily suspend a CON-approved service more than one time in a 1-year period. (7) No fewer than 30 days before the end of the 1-year or other applicable period, a health care facility that has temporarily delicensed bed capacity or its entire facility or has temporarily suspended a CON-approved service shall notify the Commission that, before the end of the 1-year or other applicable period, it will: (a) Apply to relicense the bed capacity or the entire facility temporarily delicensed or reimplement the CON-approved service temporarily suspended pursuant to this subsection; (b) Submit and receive the Executive Director's approval of a specific plan for the relicensure of the bed capacity or facility or for the reimplementation of the temporarily suspended CON-approved service, that: (i) Imposes stated time frames by which steps toward the relicensure of the bed capacity or facility or reimplementation of the service will be accomplished, or the bed capacity, facility, or service will be deemed abandoned; and (ii) May be revised upon a proposal by the owner or operator, with the approval of the Executive Director; (c) File a letter of intent, followed within 60 days by a Certificate of Need application, or request the applicable level of Commission action pursuant to Regulations .03 and .04 of this chapter, for the relocation of the bed capacity or facility, or for a capital expenditure deemed necessary to relicense the temporarily delicensed beds or facility or necessary to reimplement the temporarily suspended CON-approved service; (d) Execute a binding contract to transfer ownership of the health care facility, if the requirements of §A of this regulation are met; (e) Execute a binding contract to transfer ownership of the previously licensed bed capacity, contingent on the filing within 90 days for those filings not subject to a published review cycle or upon the Commission’s next published review schedule of a letter of intent to apply for CON approval, or other applicable level of Commission action pursuant to Regulations .03 and .04 of this chapter if required, to relocate the bed capacity; or (f) Relinquish the bed capacity or the authorization to provide the CON-approved service, or seek the appropriate Commission approval to delicense and permanently close the health care facility. (8) The Executive Director may extend the period of a temporary delicensure or temporary service suspension under this subsection beyond 1 year for good cause. (9) An application for a CON to reimplement at another location any previously operating bed capacity that has not operated for 2 or more years shall demonstrate that the bed capacity is needed in the jurisdiction. (10) Abandonment of Bed Capacity, Health Care Facility, or Service. (a) If, at the end of the 1-year period or other time period permitted under this section, the requirements of §C(5) or (7) of this regulation have not been met, no request for an extension of time has been granted pursuant to §C(6) of this regulation, and the previously delicensed bed capacity or facility has not been relicensed or the previously suspended service has not been reimplemented, the bed capacity, health care facility, or service is deemed abandoned by its owner or operator. (b) The Commission shall issue a written notice to the owner of the affected facility, and to its licensed operator if the facility is not operated by its owner, of the opportunity to respond within 30 days before the abandonment is considered final, in order to demonstrate that the previously delicensed bed capacity or facility has been relicensed or the previously suspended service has been reimplemented. E. A CON is not required to relocate an existing health care facility owned or controlled by a merged asset system, if: (1) The proposed relocation is not across jurisdictional boundaries and is to a site in: (a) The primary service area of the hospital to be relocated; or (b) The service area of the non-hospital health care facility to be relocated; (2) At least 45 days before the proposed relocation, notice is filed with the Commission, which will publish notice of the proposed relocation in the Maryland Register and a newspaper of general circulation in the affected area; and (3) The relocation of the existing health care facility does not: (a) Change the type or scope of health care services offered; and (b) In the case of a hospital, require a capital expenditure that exceeds the hospital capital threshold, except as provided in §J of this regulation. F. Change in Bed Capacity. (1) A CON is not required to increase or decrease bed capacity if: (a) For a health care facility that is not an acute general hospital, the change does not exceed ten beds or 10 percent of the facility’s total bed capacity, whichever is less, and the facility’s licensed bed capacity has not changed in the preceding 2 years; (b) For a special rehabilitation hospital or a residential treatment center, the change does not exceed ten beds or 40 percent of its current bed capacity, whichever is less, and the facility’s licensed bed capacity has not changed in the preceding 2 years; (c) For an acute general hospital located in a jurisdiction with three or more acute general hospitals, the change: (i) Is between hospitals in a merged asset system located within the same health planning region; (ii) Does not involve comprehensive care or extended care beds; (iii) Does not occur earlier than 45 days after a notice of intent to reallocate bed capacity is filed with the Commission; and (iv) Does not create a new health care service through the relocation of beds from one jurisdiction to another jurisdiction pursuant to this subsection; (d) The change in bed capacity is the result of the annual recalculation of licensed bed capacity in acute general hospitals provided for under Health-General Article, §19-307.2, Annotated Code of Maryland; (e) For an existing medical service provided by an acute general hospital: (i) The total bed capacity of the hospital does not increase; (ii) The change is maintained for at least a 1-year period, unless modified pursuant to CON or exemption from CON, or as a result of the annual recalculation of hospital licensed bed capacity required at Health-General Article, §19-307.2, Annotated Code of Maryland; and (iii) The hospital notifies the Commission at least 45 days before the proposed change in bed capacity of its medical services; or (f) At least 45 days before increasing or decreasing bed capacity, written notice of the intent to change bed capacity is filed with the Commission, and the increase or decrease in bed capacity will occur in: (i) An existing general hospice that has a current license issued by the Secretary and involves an increase in bed capacity for the provision of inpatient hospice care under the facility’s current license; or (ii) An existing intermediate care facility that offers residential or intensive substance-related disorder treatment services for withdrawal management and treatment under the facility’s current license issued by the Secretary. (2) Except as otherwise provided in this regulation, a CON is not required to decrease bed capacity at a health care facility if at least 45 days before decreasing bed capacity, written notice of the intent to change bed capacity is filed with the Commission. G. A CON is not required for a non-hospital health care facility project by a health maintenance organization if: (1) At least 90 percent of the patients who will receive health care services from the facility are enrolled in the health maintenance organization; (2) The health maintenance organization requests a determination of coverage from Commission staff that describes its proposed project, including its street address, and the health care service to be provided; and (3) Commission staff issues a determination that CON or other Commission review is not required. H. A home health agency is not required to obtain a CON to open a branch office, as defined by the Centers for Medicare and Medicaid Services at 42 CFR §484.2, although notice to the Commission is required. I. Religious Orders. (1) A CON is not required before a religious order seeks licensure to operate a comprehensive care facility for the exclusive use of members of that religious order, provided that the religious order seeks and receives a determination of coverage from Commission staff that a CON is not required. (2) The request for a determination of coverage shall provide the following: (a) The name and address of the facility; (b) The number of beds in the facility; (c) The name of the religious order that will own and operate the facility; (d) An affirmation that the facility will be owned and operated by the religious order for the exclusive use of its members; and (e) Agreement to participate in the Maryland Long-Term Care Survey, authorized by COMAR 10.24.03. (3) Commission staff shall issue a determination that either CON review is not required, with or without conditions, or that CON review is required for stated reasons. J. Hospital Capital Expenditures in Excess of the Hospital Capital Threshold. (1) A CON is not required by a hospital before it obligates an amount exceeding the hospital capital threshold for capital expenditures for physical plant construction or renovation, or before it receives a donated physical plant whose appraised value exceeds the hospital capital threshold, under the following circumstances: (a) The capital expenditure may be related to patient care. (b) The capital expenditure does not require, over the entire period or schedule of debt service associated with the project or plant, a total cumulative increase in patient charges or hospital rates of more than $1,500,000 for the capital costs associated with the project. (c) At least 45 days before an obligation is made or the physical plant is donated, the hospital provides notice to the Commission and to the Health Services Cost Review Commission, in the form of a written request for determination of coverage, as provided in Regulation .14A of this chapter, which shall contain the following information: (i) A description of the proposed capital project, including whether it involves new construction, renovation of or additions to the existing physical plant, or the donation of a physical plant, with any necessary adaptations; (ii) The total capital costs associated with the project; (iii) The sources and uses of funds to be applied to the project, including hospital equity contributions, if applicable, as documented by audited financial statements of the hospital and relevant subsidiary corporations, if any, from which funds are to be taken; (iv) A description of the financing arrangement, if applicable, for the proposed project, including the debt service schedule; and (v) A statement by one or more persons authorized to represent the hospital that the hospital does not require a total cumulative increase in patient charges or hospital rates of more than $1,500,000 for the capital costs associated with the project. (2) After consultation with the Health Services Cost Review Commission, the Commission shall issue a determination whether CON review is required within 45 days after it receives the information specified in this section. If Commission staff does not issue a determination within 60 days of receipt of all relevant financial information by the Commission and by the Health Services Cost Review Commission, the Commission is considered to have issued a determination that approval of the capital expenditure is not required by the Commission or by the Health Services Cost Review Commission. (3) Commission staff shall issue a determination that either CON review is not required, with or without conditions, or that CON review is required for stated reasons. K. Continuation of Specific Exception from Certificate of Need for Continuing Care Retirement Communities. (1) A comprehensive care facility on the campus of a continuing care retirement community is excepted from CON review, provided that the requirements of Health-General Article, §19-114(d)(2)(ii)(1), Annotated Code of Maryland, and this chapter are met, and that the number of comprehensive care beds located on the campus of the continuing care retirement community does not exceed: (a) 20 percent of the number of independent living units at a continuing care retirement community that has 300 or more independent living units; or (b) 24 percent of the number of independent living units at a continuing care retirement community that has fewer than 300 independent living units. (2) Limited Direct Admission. Notwithstanding the provisions of Health-General Article, §19-114(d)(2)(ii), Annotated Code of Maryland, a continuing care retirement community does not lose its exception from CON when the continuing care community admits an individual directly to a comprehensive care facility within the continuing care community under either of the following circumstances: (a) Two individuals having a long-term significant relationship are admitted together to a continuing care retirement community and: (i) The admission occurs after October 1, 1999; (ii) The admission includes spouses, two relatives, or two individuals having a long-term significant relationship, as defined in Regulation .01B of this chapter and supported by documentary proof in existence for at least 1 year before application to the continuing care retirement community, admitted at the same time, under a joint contract, who are jointly responsible for expenses incurred under the joint contract; and (iii) One of the individuals admitted under the joint contract will reside in an independent living unit or an assisted living unit; or (b) An individual is admitted directly into a comprehensive care bed at a continuing care retirement community and: (i) The individual must have executed a continuing care agreement and must have paid entrance fees that are at least equal to the lowest entrance fee charged by the continuing care retirement community for its independent or assisted living units; (ii) The individual must pay the entrance fee by the same method, terms of payment, and time frame as a person who immediately assumes residence in an independent or assisted living unit at that continuing care retirement community; and (iii) The individual admitted to the comprehensive care bed must have the potential for eventual transfer to an independent living unit or assisted living unit at that continuing care retirement community, as determined by the subscriber's personal physician, as defined in Regulation .01B of this chapter. (3) Under §K(2)(b)(iii) of this regulation, an individual is deemed not to have potential for eventual transfer to an independent living unit or assisted living unit if the individual can qualify for hospice services under federal Medicare regulations or if the individual has an irreversible condition that would make it unlikely that the individual could transfer to an independent living unit or assisted living unit at the continuing care retirement community. Irreversible conditions include quadriplegia, ventilator dependence, and any end-stage condition. (4) The total number of comprehensive care beds occupied by individuals who are directly admitted to comprehensive care beds pursuant to §K(2)(b) of this regulation may not exceed 20 percent of the total number of licensed and available comprehensive care beds at the continuing care retirement community. (5) The admission of the individual directly into the comprehensive care bed pursuant to §K(2)(b) of this regulation may not cause the occupancy of the comprehensive care facility at the continuing care retirement community to exceed 95 percent of its current licensed capacity. (6) The comprehensive care facility at the continuing care retirement community shall maintain an attestation by the individual's personal physician that the individual has the potential for eventual transfer to an independent living unit or an assisted living unit. (7) The nursing home administrator of the comprehensive care facility at each continuing care retirement community who admits an individual directly to a comprehensive care bed pursuant to §K(2)(b) of this regulation shall maintain information, in a format specified by the Commission, about each admission in the format required by the Commission and encrypted by the continuing care retirement community so that the individual's identity will not be disclosed. The forms shall be maintained by the nursing home administrator, to be provided to Commission staff upon its request, and shall include: (a) The number and utilization of licensed comprehensive care beds excluded from Certificate of Need requirements at the continuing care retirement community; (b) The admission source of each individual admitted pursuant to §K(2)(b) of this regulation to a comprehensive care bed excluded from Certificate of Need requirements at the continuing care retirement community; (c) For an individual admitted pursuant to §K(2)(b) of this regulation, the amount of and terms of payment for the entrance fee; (d) The dates of admission and discharge of each individual admitted pursuant to §K(2)(b) of this regulation; (e) The site to which an individual directly admitted pursuant to §K(2)(b) of this regulation is discharged; and (f) Any other information as required by Commission staff. #### Regulation .04 Exemption from Certificate of Need Review. *COMAR 10.24.01.04* A. The Commission may exempt from the requirement of CON review and approval the following actions: (1) Merger or consolidation of two or more hospitals or other health care facilities, if the facilities or an organization that operates the facilities give the Commission 45 days written notice of their intent to merge or consolidate; (2) Relocation of an existing health care facility owned or controlled by a merged asset system, if: (a) The relocation is to a site outside: (i) The primary service area of the hospital to be relocated but within the primary service area of the merged asset system; or (ii) The service area of the non-hospital health care facility to be relocated but within the primary service area of the merged asset system; and (b) The relocation of the existing health care facility does not: (i) Change the type or scope of health care services offered; and (ii) In the case of a hospital, require a capital expenditure for its construction that exceeds the hospital capital threshold, adjusted for inflation, except as provided by Regulation .03J of this chapter; (3) A change in the bed capacity of an existing health care facility pursuant to the consolidation or merger of two or more health care facilities, or conversion of a health care facility or part of a health care facility to a non-health-related use, except as provided in Regulation .03F of this chapter; (4) A change in the type or scope of the health care services offered by a health care facility, if, at least 45 days before increasing or decreasing the volume of one or more health care services, the Commission finds that the proposed change is pursuant to the: (a) Consolidation or merger of two or more health care facilities; (b) Conversion of all or part of a health care facility to a non-health-related use; or (c) Conversion of a hospital to a limited service hospital; (5) A capital expenditure that exceeds the review threshold for capital expenditure made as part of a consolidation or merger of two or more health care facilities, or conversion of a health care facility or part of a health care facility to a non-health-related use; or (6) The establishment of a freestanding medical facility through the conversion of an acute general hospital, as provided in §F of this regulation and in COMAR 10.24.19.04C. B. Unless otherwise provided in this chapter for a specific type of health care facility, complete notice of intent to seek exemption from CON review shall be filed with the Commission at least 45 days before the intended action, and shall include: (1) The name and location of each affected health care facility; (2) A general description of the proposed project including, in the case of mergers and consolidations, any proposed: (a) Conversion, expansion, relocation, or reduction of one or more health care services; (b) Renovation of existing facilities; (c) New construction; (d) Relocation or reconfiguration of existing medical services; or (e) Change in bed capacity at each affected facility; (3) The scheduled date of the project's completion; (4) Identification of each outstanding public obligation; (5) Information demonstrating that the project: (a) Is not inconsistent with the State Health Plan; (b) Will result in the delivery of more efficient and effective delivery of health care services; and (c) Is in the public interest; and (6) Any other information, analyses, or other requirements established in State Health Plan regulation for requests seeking exemption from CON review. C. Notice by the Commission to the Public, Elected Officials, and Other State Agencies. (1) Within 5 days after it receives a complete Notice of Intent from a health care facility seeking exemption from CON review, the Commission shall publish notice of its receipt: (a) In at least one newspaper of general circulation in the affected area; (b) In the next available issue of the Maryland Register; and (c) On the Commission’s website. (2) The Commission shall mail the same notice to elected public officials in whose district or jurisdiction the exemption from CON review is proposed. (3) The Commission shall solicit comment from the affected public, in evaluating whether the action or project proposed for exemption from CON review is in the public interest. D. Public Informational Hearing. (1) An acute general hospital shall hold a public informational hearing in the jurisdiction where it is located within 30 days after it has filed with the Commission notice of its intent to: (a) Close; (b) Partially close, if the hospital is located in a jurisdiction with fewer than three acute general hospitals; or (c) Convert to a limited service hospital or freestanding medical facility. (2) Before holding the public informational hearing, the hospital shall consult with the Commission, to ensure that: (a) Within 5 days of notifying the Commission of its intent to close, partially close, or convert, the hospital has provided public notice of the proposed closure or conversion and of the time and location of the required public informational hearing and how the public can electronically obtain additional information, including publication in at least one newspaper of general circulation in the affected area; and (b) The public hearing will address the information required by §D(3) of this regulation. (3) Requirements for a Public Informational Hearing. (a) The acute general hospital proposing to close, partially close, or convert to a limited service hospital or freestanding medical facility shall hold a public informational hearing at the hospital or if that is not feasible at a public meeting area near the hospital. (b) The hospital shall post a notice of the public informational hearing in public areas of its facility and on the landing page of its website. (c) The hospital shall identify to the public the names of the senior management and Board of Directors attending the hearing; (d) The hospital shall present at least the following information at the public informational hearing: (i) The reasons for the closure, partial closure, or conversion; (ii) The plan for transitioning acute care services previously provided by the hospital to residents of the hospital service area; (iii) The plan for addressing the health care needs of the residents of the hospital service area; (iv) The plan for retraining and placing displaced employees; (v) The plan for the hospital’s physical plant and site; and (vi) The proposed timeline for the closure, partial closure, or conversion to a freestanding medical facility. (e) The public informational hearing shall be recorded. (f) Within 10 business days after the public informational hearing, the hospital shall make available on its website a recording of the public informational hearing and provide a written summary of the hearing, which shall also be provided to: (i) The Governor; (ii) The Secretary; (iii) The governing body of the jurisdiction in which the hospital is located; (iv) The local health department and the local board of health or similar body for the jurisdiction in which the hospital is located; (v) The Commission; and (vi) Subject to State Government Article, §2-1257, Annotated Code of Maryland, the Senate Finance Committee, the House Health and Government Operations Committee, and the members of the General Assembly who represent the district in which the hospital is located. E. Commission Action. (1) Unless otherwise provided in this chapter for a specific type of health care facility, the Commission shall issue an exemption from CON review to the health care facility or the merged asset system seeking this determination within 45 days after it receives the notice of intent required by §B of this regulation, if: (a) The facility or system has provided the information required by the notice of intent, and has held a public informational hearing if required by §D of this regulation; and (b) The Commission, in its sole discretion, finds that the action proposed: (i) Is not inconsistent with the State Health Plan or an institution-specific plan developed by the Commission under Health-General Article, §19-119, Annotated Code of Maryland; (ii) Will result in more efficient and effective delivery of health care services; and (iii) Is in the public interest. (2) For any project that the Commission may exempt from CON review under §A of this regulation, for which a final Commission decision has not been issued within 45 days after it receives a complete notice of intent as required by §B of this regulation, Commission staff shall provide a status report at the next Commission meeting and any subsequent Commission meeting stating the reasons for the delay and the expected time frame for issuing its final decision. (3) CON review is not required and the exemption request shall be deemed approved for any project which the Commission may exempt from CON review under §A of this regulation if final action by the Commission does not occur within 90 days after the facility or system has provided complete notice of intent as required by §B of this regulation and has held a public hearing if required by §D of this regulation. (4) Upon request, Commission staff shall provide written confirmation that an exemption request has been deemed approved in accordance with §E(3) of this regulation. F. Freestanding Medical Facility. (1) In accordance with COMAR 10.24.19.04C and this regulation, the Commission may exempt from CON review the establishment of a freestanding medical facility as a result of a conversion from a licensed acute general hospital. (2) At least 60 days before the conversion, written notice of intent to convert the licensed general hospital to a freestanding medical facility shall be filed with the Commission in accordance with COMAR 10.24.19.04C. (3) Provided that all the requirements of this regulation and COMAR 10.24.19.04C are met, the Commission shall grant the exemption if it finds, in its sole discretion, that the conversion: (a) Is consistent with the State Health Plan; (b) Will result in the delivery of more efficient and effective health care services; (c) Will maintain adequate and appropriate delivery of emergency care within the statewide emergency medical services system as determined by the State Emergency Medical Services Board; and (d) Is in the public interest. (4) The Commission may approve, approve with conditions, or deny the requested exemption. (5) Failure to maintain compliance with conditions on an exemption or with the time frame for completion of the conversion may result in withdrawal of the exemption issued by the Commission in accordance with Regulation .12 of this chapter. An exemption holder may request approval of a reasonable modification to the conversion timeline in accordance with Regulation .12A(4) of this chapter. #### Regulation .05 Ambulatory Surgery Centers: Determination of Coverage and Data Reporting. *COMAR 10.24.01.05* A. Determination of Coverage. (1) A CON is not required for an ambulatory surgery center. (2) A person shall obtain a determination of coverage from the Commission before: (a) Establishing a new ambulatory surgery center; (b) Adding a new operating room or any other rooms in which procedures are performed to an existing ambulatory surgery center; or (c) Making any change in the information provided for initial determination of coverage. (3) Change in Location. A determination of coverage for an ambulatory surgery center is issued only for the exact address specified in the determination. A change in address or in the layout of the center before it is built, developed, or established requires a new determination of coverage. (4) Change in Ownership. A determination of coverage regarding an ambulatory surgery center is issued only for the person specified in the determination. If the principal owner or a majority of other owners of an existing ambulatory surgery center is expected to change, a request for a new determination of coverage shall be filed and include: (a) A complete list of the existing owners and the post-transaction owners; and (b) An attestation by the ambulatory surgery center that, subsequent to the issuance of the original determination of coverage, no changes have been made and that, as a result of the planned change in ownership, no changes will be made: (i) To the physical plant or layout of the ambulatory surgery center; or (ii) In the surgical specialties provided. (5) Expiration of Determination of Coverage. A determination of coverage for a new ambulatory surgery center or for new capacity at an existing ASC-P or ASC-1 may be issued and is effective for 2 years from the date of the determination. If that capacity is not built or established within 2 years, the determination of coverage is void. (6) Notice. Before seeking to establish a new operating room or any other rooms in which procedures are performed, or to make any change in the information provided for initial determination of coverage, a person shall provide notice to the Commission at least 45 days in advance that includes all information required by COMAR 10.24.11.04A. (7) For purposes of this regulation, all ambulatory surgery centers that are located in the same building and that share any common ownership or control shall be considered one entity, and their operating rooms shall be considered together for purposes of determining coverage under Regulation .02 of this chapter. (8) Except as provided in this regulation or permitted in the Certificate of Need or exemption criteria in the State Health Plan under COMAR 10.24.11, an ambulatory surgical facility or other entity primarily providing ambulatory surgical services may not relocate beyond an adjacent site or expand its number of operating rooms without obtaining a Certificate of Need. (9) A CON is not required for ambulatory surgical services provided as part of an office of one or more individuals licensed to practice dentistry under Health-Occupations Article, Title 4, Annotated Code of Maryland, for the purpose of practicing dentistry, if the ambulatory surgical facility is not used in a medical practice other than dentistry. B. Data Reporting and Annual Survey of Ambulatory Surgical Centers, Facilities, and Providers. (1) To provide information for the Commission's planning purposes and to determine changes in circumstances and operation that may affect coverage by CON requirements, each existing ambulatory surgery center, facility, office, and provider that primarily provides ambulatory surgical services shall annually provide to the Commission the information required by COMAR 10.24.04. (2) A person providing ambulatory surgical services who is required to obtain a license under Health-General Article, §19-3B-02(a), Annotated Code of Maryland, shall annually provide the required information on a form provided by the Commission. #### Regulation .06 Access to Information and Facilities. *COMAR 10.24.01.06* To the extent permitted by law, an applicant shall provide access to general information, records, plans and specifications, meetings, sites, and facilities to Commission staff upon proper notice and as is reasonable and necessary in the performance of the Commission's responsibilities. The Commission may require other health care providers to provide similar information. #### Regulation .07 Preapplication Procedures. *COMAR 10.24.01.07* A. Letter of Intent. (1) A prospective applicant for a Certificate of Need shall submit to the Center for Health Care Facilities Planning and Development a brief letter of intent, with a copy to each local health department in the health planning region. The Center for Health Care Facilities Planning and Development shall formally log all letters of intent upon receipt. (2) A prospective applicant identified in a letter of intent may be the person or persons who will be the licensee. If the legal entity that will be the licensee has not yet been formed or finalized at the time of filing a letter of intent: (a) A prospective applicant shall identify the intended ownership and control of the licensee with the same level of specificity as required in §A(3) of this regulation; and (b) The legal entity that will be the licensee shall be formed at the time of filing an application for a CON. (3) The letter of intent shall include the following information: (a) The identity of each person on whose behalf the letter of intent is filed, including: (i) The name and address of each such person; and (ii) In the case of a letter of intent filed on behalf of a person that is not a natural person, the date the entity was formed, the business address of the entity, and the identity and percentage of ownership of all persons having an ownership interest of 5 percent or more in the entity; (b) A description of the proposed project; (c) The quantity and types of beds or health services involved; and (d) The specific location and each jurisdiction in which services will be provided, according to the relevant planning region in the State Health Plan for that facility or service. (4) A letter of intent shall be submitted in accordance with the published review schedule established by the Commission in accordance with Regulation .08D of this chapter, but if no applicable review schedule has been published, a letter of intent may be submitted at any time. (5) Notice of the receipt of a letter of intent for a project not subject to a published review schedule shall be placed in the Maryland Register, and a 30-day period initiated for the submission of any other letters of intent for comparable projects to be included in a comparative review. (6) Upon docketing of an application, the letter of intent for that project is no longer valid for purposes of comparative review. (7) If a letter of intent is submitted for a proposed health care project which might be comparable to a project application which has been submitted but not yet docketed, the projects shall be given a comparative review. (8) Notwithstanding any other regulation in this chapter, no letter of intent or application shall initiate a comparative review with an earlier filed letter of intent or application if the earlier filed letter of intent predates the later filed letter of intent by a period of more than 60 days, unless the Executive Director finds that the applicant in the earlier filed matter has unreasonably delayed in the advancement of its application through staff’s completeness review, and that good cause exists to review the projects in comparative review. (9) If a person submits a letter of intent for a proposed health care project that might be comparable to an application which has already been docketed, a comparative review may not be conducted. (10) If an application for a CON is not filed in accordance with Regulation .08A(1) of this chapter, the letter of intent is void. (11) Letters of intent are subject to public inspection during normal business hours. B. Preapplication Conference. After the filing of a letter of intent, an applicant may request that the Commission staff arrange a preapplication conference to discuss: (1) Commission procedures for reviewing the application or applications; (2) Information and data to be included in the application or applications; (3) The State Health Plan requirements that may affect the project; and (4) Other matters relevant to the filing and processing of the application or applications. C. The discussions in §B of this regulation are informal, and statements at the meetings are not admissible as evidence at a Commission proceeding. #### Regulation .08 Procedure for Review of CON Applications. *COMAR 10.24.01.08* A. Review Schedule. (1) An application shall be submitted in accordance with the published review schedule established by the Commission in accordance with §D(1) of this regulation, but if no applicable review schedule has been published, an application may be submitted at any time 60 days after the filing of the letter of intent but no more than 180 days after the filing of the letter of intent, unless a shorter period has been approved by the Executive Director. (2) In a case when need for additional service capacity is projected, the Commission may not docket an application until it has made a final decision on each previously docketed application for a comparable project, unless the most recently published need projections or State Health Plan would support the approval of both projects. B. Submission of Application. (1) An application for a CON shall be submitted to the Commission's Center for Health Care Facilities Planning and Development in the form and manner prescribed by the Commission. (2) The application, and all information supplementing the application, shall be signed by at least one principal of the applicant, who shall sign a statement as follows: “I solemnly affirm under penalties of perjury that the contents of the application (or the supplementary information) are true to the best of my knowledge, information, and belief.” C. Completeness Review and Docketing. (1) Prior to docketing an application for review, Commission staff shall review the application for completeness: (a) Within 20 business days for projects involving the establishment of a health care facility, the relocation of a health care facility or the introduction by a hospital of cardiac surgery or organ transplantation; and (b) Within 15 business days for all other projects. (2) Commission staff may schedule a conference with the applicant within the completeness review period prescribed in §C(1) of this regulation. (3) Commission staff shall determine whether the application contains all the information requested in the application. If staff determines that the application is not complete, the staff shall make one written request for additional information that specifies the information requested and the 15-business-day deadline for the applicant to supply the requested information. For good cause, staff may make one additional request for information, to which the applicant shall have 10 business days to respond. Additional information may be requested by staff beyond that required to make the application complete, which shall also be subject to a time limit for the applicant to supply the requested information. (4) If Commission staff determines, based on staff’s review of the application and any additional information provided in response to a staff request for additional information, that the application is complete and conforms with the applicable docketing rules in the State Health Plan, the staff shall docket the application for review and publish notice of the docketing on the next available publication date of the Maryland Register. (5) If an applicant fails to supply the required information within the specified time limit, staff may dismiss the application. Staff may, at its discretion, extend the response time for an applicant in a noncomparative review, or, with the consent of all applicants, for an applicant in a comparative review, up to an additional 10 business days, or more upon a demonstration of good cause for the additional extension. (6) Commission staff or a reviewer may: (a) Request information from the applicant supplementing an otherwise complete application at any time during the review of an application; and (b) Set reasonable time limits for the applicant to supply the requested information. D. Notice to the Public. (1) At least once each year, Commission staff shall publish in the Maryland Register a schedule for conducting reviews of applications for designated services by health planning region, as follows: (a) The schedule shall include the status of applicable need forecasts found in the State Health Plan or published elsewhere as required by the State Health Plan for conducting the reviews of the designated services by health planning region; (b) The schedule shall establish application submission dates not sooner than 3 months following the publication of the proposed schedule; and (c) The schedule shall identify scheduled reviews by health planning region and shall state the dates for the receipt of letters of intent and the submission of applications. (2) Within 10 business days of receiving a complete application, Commission staff shall request that the Maryland Register publish notice to the public of the docketing of an application. The Commission shall also publish notice in a newspaper of general circulation in the area of the proposed project. Notices shall comply with State Government Article, §10-207, Annotated Code of Maryland, and shall include: (a) A citation to the Commission's enabling act and this chapter, the name of the applicant, the matter or docket number, and a general description of the project containing the information required in letters of intent; (b) An explanation that a person who meets the definition of “interested party” in Regulation .01B of this chapter may become an interested party to the review of this application by submitting written comments on the application within 30 days of its docketing; and (c) A statement that a person may request in writing that the Commission advise them of further notices of the proceedings on the application, and that any further notice of proceedings will only be sent to persons who have submitted a written request. (3) If an evidentiary hearing is held in accordance with Regulation .11 of this chapter, the Commission shall provide notice to each person who has requested to be apprised of further proceedings on the application. E. Modifications to Letters of Intent and Applications. (1) An applicant shall give written notice to the Center for Health Care Facilities Planning and Development of any modifications to the applicant's letter of intent before submitting an application. (2) An application may be modified until the 45th day after docketing. After the 45th day of docketing, an application may only be modified as a result of a project status conference held pursuant to Regulation .09A(2) of this chapter or upon a showing of good cause. (3) If an application is modified: (a) The Commission shall provide: (i) Notice of the changes by a dated posting on the Commission's website and in a newspaper of general circulation in the affected jurisdiction; and (ii) A 10-business-day period following the website posting for comments on the changes; and (b) Each applicant in the review will be deemed to have waived the right to a final decision by the Commission within the statutorily prescribed time. (4) The following modifications to a proposed project require a new Certificate of Need application: (a) Changes in the fundamental nature of a proposed facility or the medical services to be provided; (b) Increases in the total bed capacity of a proposed facility; or (c) A change in the site of a proposed facility. F. Comments by a Person Seeking Interested Party Status or by a Participating Entity and Applicant's Response. (1) Written Comments by a Person Seeking Interested Party Status. (a) A person seeking interested party status shall file written comments on an application within 30 days of docketing. (b) The comments shall include information sufficient to establish interested party status, as defined in Regulation .01B of this chapter. (c) If a person seeking interested party status is opposing an application, the comments shall state with particularity the State Health Plan standards or the review criteria in §G of this regulation that the person seeking interested party status believes have not been met by the applicant and the reasons why the applicant does not meet those standards or criteria. (d) Factual assertions made in comments by a person seeking interested party status that are not included in the record shall be accompanied by appropriate documentation and sworn affidavit. (e) In a review with only one applicant, the comments shall be 25 pages or fewer, double-spaced, excluding attachments. (f) In a comparative review, the comments shall be 35 pages or fewer, double-spaced, excluding attachments. (2) Written Comments by a Person Seeking Participating Entity Status. (a) A person seeking participating entity status shall file written comments on an application within 30 days of docketing that: (i) Include information that the participating entity wishes the Commission to consider; and (ii) State with particularity the State Health Plan standards or review criteria in §G of this regulation that it believes have not been met by the applicant, and the reasons why the applicant does not meet those standards or criteria. (b) A person granted participating entity status shall be copied on Commission documents in the review of the application. (c) A person granted participating entity status is not an interested party and has no right to judicial review of a final Commission decision. (3) Response to Comments. (a) An applicant is permitted to make one written filing responding to all written comments on its application within 15 days of receipt of those comments. (b) The applicant’s response may not be more than 25 pages, double-spaced, excluding attachments. (c) In a comparative review, the applicant’s response may not be more than 35 pages, double-spaced, excluding attachments. (d) Factual assertions in an applicant's response that are not included in the record shall be accompanied by appropriate documentation and sworn affidavit. G. Criteria for Review of Application. (1) In a Certificate of Need review, the applicant carries the burden of proving by a preponderance of the evidence that the project meets the applicable criteria for review. (2) In reviewing an application for a CON, the Commission shall consider the applicant's submissions, the comments, if any, of interested parties, participating entities, the local health department, and information gathered during the Commission’s review of the application, to which each applicant and interested party has been afforded the opportunity to respond. In a comparative review the Commission shall award a CON to the applicant, or applicants, that best meet the review criteria in §G(3) of this regulation. (3) Criteria for Review of an Application for Certificate of Need. (a) State Health Plan. An application for a Certificate of Need shall be evaluated according to all relevant State Health Plan standards. (b) Need. The Commission shall consider the applicable need analysis in the State Health Plan. If no State Health Plan need analysis is applicable, the Commission shall consider whether the applicant has demonstrated a need for the proposed project. (c) Alternatives to the Project. The Commission shall consider the alternative approaches to meeting the need identified for the project that were considered by the applicant in planning the project and the basis for the applicant’s choice of the project among considered alternatives. In a comparative review of applications within the same review cycle, the Commission shall compare the costs and the likely effectiveness of alternative projects in meeting identified needs, improving the availability and accessibility of care, and improving the quality of care. (d) Project Financial Feasibility and Facility or Program Viability. The Commission shall consider the availability of resources necessary to implement the project and the availability of revenue sources and demand for the proposed services adequate to ensure ongoing viability and sustainability of the facility to be established or modified or the service to be introduced or expanded. (e) Compliance with Terms and Conditions of Previous Certificates of Need. An applicant shall demonstrate compliance with all terms and conditions of each previous CON granted to the applicant. (f) Project Impact. The Commission shall consider the impact of the proposed project on the costs and charges of existing providers of the facilities and services included in the project and on access to those facilities and services in the service area of the project. (g) Health Equity. The Commission shall consider how a proposed project will address health care disparities in availability, accessibility, and quality of care among different populations within the service area. The Commission shall consider how social determinants of health within the service area of the proposed project create disparities in the delivery of health care. (h) Character and Competence. The Commission shall assess the character and competence of an applicant based upon experience and past performance, including any records of violation in operating a health care service or facility. #### Regulation .09 Commission Decision and Action on CON Applications. *COMAR 10.24.01.09* A. Proposed Decision. (1) Preparation of Proposed Decision. (a) In a comparative or contested review, or in a review in which an evidentiary hearing is held in accordance with Regulation .11 of this chapter, the Executive Director shall appoint a single Commissioner, who may be assisted by the staff of the Commission, to act as reviewer and prepare a proposed decision for consideration by the Commission. (b) In all other reviews, Commission staff shall review the application and prepare a staff report and recommendation for consideration by the Commission. (2) Project Status Conference. (a) The reviewer or staff, as appropriate, may request that a project status conference be held before the issuance of a proposed decision or staff report, to apprise each applicant, interested party, and participating entity of those aspects of a proposed project that appear to be inconsistent with applicable standards and review criteria. (b) Following the project status conference, the reviewer or staff will send each applicant, interested party, and participating entity a summary of the project status conference that includes dates, as needed, for additional filings. (c) The applicant shall send to each interested party and participating entity a copy of proposed project changes made pursuant to the project status conference. (d) Each interested party and participating entity in the review of an application shall have 7 days to file comments on the proposed changes made pursuant to the project status conference. (3) Opportunity to Present Oral Argument. Each applicant and interested party in a contested or comparative review may request the opportunity to present oral argument to the reviewer before the reviewer prepares a proposed decision on the application for consideration by the full Commission, as follows: (a) The request shall be made within the time period for an applicant's response to comments under Regulation .08F(1) of this chapter; (b) The decision to grant oral argument is at the sole discretion of the reviewer; (c) The reviewer may set reasonable time limits for oral argument; and (d) The reviewer may, if there is a genuine dispute as to the credibility of a material witness on a matter of fact, require the witness to answer questions on that matter under oath during the oral argument portion of a CON review. (4) A staff report and recommendation on a proposed project or a reviewer’s proposed decision on a project shall state the staff’s conclusion or the reviewer's finding as to whether: (a) Each relevant State Health Plan standard or review criterion set forth in Regulation .08G of this chapter: (i) Is met by the applicant; (ii) Is not applicable to the project; or (iii) Is applicable to the project and is not met by the applicant; (b) In a comparative review, one or more of the projects is preferred under a State Health Plan standard or criterion either as a result of consideration of a preference standard or because one or more of the projects was determined to be superior based on the reviewer’s consideration of the applicable criteria; and (c) To recommend that one or more of the projects be granted a CON. B. Exceptions. (1) Pursuant to State Government Article, §10-216, Annotated Code of Maryland, each applicant and interested party who has submitted comments under Regulation .08F(1) of this chapter may submit written exceptions to a staff report and recommendation or a proposed decision and make oral argument to the Commission. (2) Schedule. (a) A proposed decision in a contested or comparative review shall be issued at least 30 days before the Commission meeting at which the proposed decision and order will be considered. (b) Upon issuance of a staff report or proposed decision, Commission staff shall issue a notice specifying the schedule for the submission of exceptions and any response, the date on which the Commission shall hear oral argument, and rules for conduct of the hearing. (c) Unless otherwise agreed by each applicant and interested party, the schedule issued by Commission staff in a contested or comparative review shall specify that exceptions shall be filed on a date at least 10 days after the issuance of a proposed decision and any response to the exceptions filed on a date at least 7 days after the filing of exceptions. The Commission staff may shorten these periods by agreement of the parties, or extend any deadlines set for good cause shown. (3) Exceptions Requirements. (a) Exceptions shall specifically identify each finding and conclusion to which exception is taken, citing those portions of the record on which each exception is based. (b) Exceptions shall be limited to 25 pages, double-spaced, excluding attachments. (c) Responses to exceptions shall be limited to 15 pages, double-spaced, excluding attachments. (4) Oral arguments before the full Commission concerning the proposed decision are limited to 10 minutes per applicant and 10 minutes per interested party, unless extended by the Chair of the Commission. An applicant may reserve time for rebuttal. C. Participation By Participating Entity In Certain Reviews After Issuance of a Staff Report or Reviewer's Proposed Decision. (1) Request by Participating Entity to Address the Commission. (a) After the issuance of a staff report or a reviewer's proposed decision, a participating entity may request the opportunity to address the Commission before Commission action on the application by submitting a written request at least 7 days before the scheduled Commission meeting that will consider an application, specifying the points that it wants to make. (b) The Chair of the Commission, after consultation with the Executive Director, may permit a participating entity, or combination of participating entities, to make an oral presentation to the Commission on matters it addressed in written comments on the application. (c) At least 5 days before the scheduled Commission meeting that will consider an application, the Executive Director shall advise each applicant, interested party, and participating entity in a review whether the Chair will permit a participating entity or combination of participating entities to make an oral presentation to the Commission, and shall specify the format of the presentation. (2) An applicant may address the Commission in any review in which a participating entity is granted permission to address the Commission before action on an application. D. Final Decision. (1) The Commission's final decision on a project shall contain findings of fact and conclusions of law and: (a) Approve the application; (b) Approve the application with conditions; or (c) Deny the application. (2) The decision of the Commission shall be by a majority of the quorum present and voting. E. Action on the Application. (1) The Commission shall act on an application for a CON not later than 150 days after the application has been docketed. If no evidentiary hearing is held, the Commission shall act on an application within 90 days after the docketing of the application. Staff shall report to the Commission the status of all projects where a staff report is not issued for Commission action within 90 days. (2) With the exception of CON applications to establish a health care facility, relocate a health care facility, or establish cardiac surgery services or organ transplantation services at an existing acute general hospital, a CON application filed after October 1, 2019 shall be deemed approved if the application is uncontested and final action by the Commission does not occur within 120 days after the application is docketed. (3) On motion by an applicant or an interested party, a review of a CON application may be stayed for a period not to exceed 6 months if the reviewer, or if a reviewer is not appointed, the Executive Director, determines that there is good cause for a stay. (4) The Commission shall notify the applicant, interested parties, participating entities, and the local health department of the Commission’s final decision. (5) The Commission may not render a final decision until: (a) A staff report and recommendation or a reviewer’s proposed decision has been provided to each party; and (b) Each applicant and interested party has been given an opportunity to file exceptions and present oral argument before the Commission. F. Judicial Review. (1) The Commission's final decision is subject to judicial review under State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (2) In order to seek judicial review, a party must be an aggrieved party. (3) For purposes of judicial review, the record of the proceeding shall include: (a) The application; (b) Requests to an applicant for additional information from Commission staff, the reviewer, the Commission, and responses to the requests; (c) Comments received from each interested party and responses from each applicant; (d) Reports or recommendations from staff; (e) Motions and responsive filings; (f) The prehearing conference report, if any; (g) Prefiled testimony, if any; (h) A recording or transcript of any hearing; (i) The reviewer's proposed decision, all exceptions, and responses to exceptions; and (j) The Commission's final decision. (4) A decision of the Commission is a final decision for purposes of judicial review. (5) A request for reconsideration in accordance with Regulation .19 of this chapter will stay the final decision of the Commission for purposes of judicial review until the Commission decides the request for reconsideration. #### Regulation .10 Miscellaneous Rules and Procedures. *COMAR 10.24.01.10* A. Computation of Time. (1) In computing a period of time prescribed by these regulations, by order of the Commission, or by an applicable statute, the day of the action or default initiating the designated period of time is not included. The last day of the period so computed is to be included unless it is a day on which the office of the Commission is closed, in which event the period extends until the next day on which the office of the Commission is open. Unless otherwise noted, all time periods shall be computed in calendar days. (2) At the discretion of the reviewer, the Executive Director, or the Executive Director's designee, and upon a showing of good cause by the submitting party, a period of time to submit a document or perform any act permitted or prescribed by these regulations may be extended for a reasonable period of time. B. Filing of Documents. In all matters before the full Commission, filings may not be made directly to individual commissioners except at the direction of the reviewer or the Executive Director. C. Motion Practice. (1) A motion shall be made in writing, except when made at a hearing or prehearing conference in accordance with Regulation .11 of this chapter, and shall state concisely the action the movant desires the Commission to take, and supporting grounds and authority. (2) A motion shall be filed within 20 days of the determination to which the motion responds. (3) The following actions shall be taken by motion: (a) A demand for an action which the movant desires the Commission, the reviewer, or the staff of the Commission to take; (b) A request for reconsideration, under Regulation .19 of this chapter; (c) An objection to the introduction of a statement or other evidence by a party during an evidentiary hearing held under Regulation .11 of this chapter; (d) A challenge to a reviewer or other member of the Commission; (e) An action that might be initiated properly or undertaken by a party to a review, and that is not otherwise provided for in this chapter; and (f) Any other question that is justiciable. (4) A motion need not be verified unless it is based on facts not apparent from the record or documents filed in the proceeding. (5) An applicant or interested party to the review may file one written answer to a motion, in the same format required of motions, within 10 days of the filing of the motion. (6) Except as otherwise provided in these regulations, the reviewer or, in a matter in which no reviewer has been appointed, the Executive Director shall rule on a motion made prior to the issuance of a proposed decision or staff recommendation. Except as otherwise provided in these regulations, the Chair shall rule on all other motions. (7) The person presiding over the motion may hear oral argument on the motion at the request of a party. D. Summary Decision. (1) At any time after an application is docketed, staff may file a motion for summary decision to deny the application. (2) The motion shall identify the grounds for the motion, which is not required to address every applicable State Health Plan standard. The applicant may respond to the motion in writing, within 15 days of receipt of the motion. (3) The reviewer, or, in a matter in which no reviewer has been appointed, a commissioner appointed as motions officer by the Executive Director, may hear oral argument on the motion at the request of a party and shall issue a proposed ruling which shall be subject to review by the full Commission. (4) A quorum of the full Commission shall make a final ruling on the motion for summary decision. E. Ex Parte Contacts. After the docketing of an application and until the Commission renders its final decision under this regulation, the ex parte provisions of the State Government Article, Title 10, Annotated Code of Maryland, apply. F. Local Health Department Review and Comment. The Commission shall seek information and comment from each local health department in the health planning region for the proposed project, and shall consider any response from each health department in making a final decision on an application. G. Required Approvals. (1) Except in emergency circumstances posing a threat to public health, all decisions of the Commission on an application for a Certificate of Need shall be consistent with applicable State Health Plan standards and criteria established by the Commission. (2) Unless the Commission finds that the facility or service for which a proposed expenditure is to be made is not needed or is not consistent with the State Health Plan, the Commission shall approve an application for a Certificate of Need to the extent that the expenditure will be made to eliminate or prevent an imminent safety hazard, as defined by federal, State, or local fire, building, or life safety codes or regulations, to comply with State licensing standards, or to comply with accreditation standards for reimbursement under Title XVIII of the Social Security Act or under the State Medical Assistance Program approved under Title XIX of the Social Security Act. H. Notice of Final Action on a Certificate of Need Application. The Commission shall provide a copy of a CON decision to State or local licensing agencies, the Maryland Medical Assistance Program, and the Health Services Cost Review Commission. I. Participation of Staff. A reviewer may seek the assistance of any member of the Commission staff in preparing a proposed decision. J. Transferability. A Certificate of Need or other Commission approval is not transferable. K. Consent Agenda. (1) The Commission may take action on the following categories of items by use of a consent agenda at a public meeting of the Commission: (a) Adoption of final regulations previously adopted by the Commission as proposed permanent regulations that: (i) Do not result in public comments after publication in the Maryland Register; and (ii) Contain no wording changes. (b) A change in an approved project that requires Commission approval pursuant to Regulation .17 of this chapter and is recommended for approval by the Executive Director with the exception of: (i) An increase in the capital cost of a project that exceeds the approved capital cost inflated by the cost index specified in Regulation .17 of this chapter that also includes a change in the financing mechanism of the project; or (ii) A change in the financing mechanism of the project. (c) Confirmation of an emergency CON issued by the Executive Director in accordance with Regulation .20 of this chapter. (d) Other categories of actions that a majority of the fully authorized membership of the Commission votes to include on the consent docket. (2) Consent agenda items shall be disseminated to the Commissioners prior to the meeting along with copies of any related materials. At the beginning of the meeting, the Chair of the Commission will present the consent agenda to the Commissioners and ask whether anyone wishes to remove an item from the consent agenda to the main agenda or the next scheduled meeting. Items may be removed from the consent agenda on the request of any one Commissioner. Items not removed may be adopted by general consent without debate. Removed items may be taken up either immediately after the consent agenda, placed later on the agenda, or moved to the meeting that follows at the discretion of the Chair. #### Regulation .11 Evidentiary Hearings. *COMAR 10.24.01.11* A. Request for Evidentiary Hearing. (1) Except as otherwise provided in these regulations, a request for an evidentiary hearing shall be made within 45 days of the docketing of an application or within 30 days after the modification of an application in a review. (2) At the request of an applicant or interested party, the Commission may hold an evidentiary hearing in the review of a CON application for any health care facility other than an ambulatory surgical facility if, in the judgment of the reviewer, an evidentiary hearing is appropriate due to the magnitude of the impact that the proposed project may have on the health care delivery system and the project, if approved, would result in one of the following: (a) A substantial negative impact on the costs and charges for the type of the facility, services, or both included in the project; (b) A substantial negative impact on access to those facilities and services by the population in the proposed project’s expected service area; (c) A significant decrease in the availability and overall quality of health care services in the affected area in a manner not consistent with policies or need projections set forth in the State Health Plan, such as by causing a loss of reasonable access to an essential medical service by a substantial number of patients; or (d) Any impact that the reviewer concludes may be sufficiently serious to merit an evidentiary hearing. B. General. (1) Reviewer as Presiding Officer. (a) If an evidentiary hearing is held in accordance with this chapter, the reviewer shall: (i) Conduct a full, fair, and impartial hearing; (ii) Take action to avoid unnecessary delay in the disposition of the proceedings; and (iii) Maintain order. (b) A reviewer has the power to regulate the course of an evidentiary hearing and the conduct of the parties and authorized representatives, including the power to: (i) Administer oaths and affirmations; (ii) Rule upon offers of proof and receive relevant and material evidence; (iii) Consider and rule upon motions in accordance with this chapter; (iv) Examine witnesses and call witnesses as necessary to ensure a full and complete record; (v) Limit unduly repetitious testimony and reasonably limit the time for presentations; (vi) Grant a continuance or postponement; (vii) Modify or waive, reasonably and for good cause, any time periods established by this chapter; (viii) Request that parties submit legal memoranda, proposed findings of fact, and proposed conclusions of law; (ix) Make proposed decisions and take any other appropriate action authorized by law; (x) Issue orders as are necessary to secure procedural simplicity and administrative fairness and to eliminate unjustifiable expense and delay; and (xi) Conduct the hearing in a manner suited to ascertain the facts and safeguard the rights of the parties to the hearing. (c) The reviewer may impose appropriate sanctions for failure to abide by this chapter or any lawful order of the reviewer. (2) Conduct of Evidentiary Hearings. (a) An evidentiary hearing need not be conducted according to technical rules of evidence, but shall be conducted in accordance with the State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and these regulations. (b) Reliable hearsay is admissible. (c) Rules of privileges are effective to the extent they would be effective in a judicial proceeding in Maryland. (d) Nonexpert opinion testimony may be considered. (e) Qualification as an expert lies within the discretion of the reviewer. The qualification of an expert need not be based on academic degrees. Reasonably extensive practical experience with the subject may be sufficient for an expert qualification. (f) Reliable and probative documents previously filed with or compiled by the Commission or its staff or consultants that are relevant to issues being considered by the Commission may be incorporated by reference into the record of a proceeding by the Commission or, by leave of the reviewer, by a party to the proceeding, upon notice to the parties and an opportunity to object. (g) The reviewer may take administrative notice of all judicially cognizable facts to the same extent as courts of this State, either on the reviewer's own motion or at the request of a party. The reviewer may also take official notice, without meeting formal evidentiary rules, of general technical or scientific facts within the specialized knowledge of a member of the Commission. A party to the hearing is entitled, on timely request, to an opportunity to show that the Commission should not take administrative or official notice of specific facts and matters, or that the fact or matter to be officially noticed is inapplicable to the proceeding or is incorrect or misunderstood by the Commission. (3) A party to the hearing may be represented by counsel. (4) The prehearing conference and the hearing shall be recorded. If an applicant or other person desires a transcript, that person shall pay all costs to transcribe the recording. (5) Documents filed in the proceeding shall be served on the reviewer, the assistant attorneys general of the Commission, and each interested party, and shall include a certificate of service. C. Prehearing Procedures. (1) The reviewer shall hold a prehearing conference, and may hold settlement conferences, before an evidentiary hearing. (2) The reviewer shall notify each applicant and interested party of the prehearing conference in writing. The notification shall: (a) Include the date, time, and place of the prehearing conference or conferences; (b) Summarize the rules of procedure governing the evidentiary hearing; and (c) State the dates, if known, for the submission of prefiled testimony and the date, time, and place of the evidentiary hearing. (3) The principal purpose of the prehearing conference is to expedite the evidentiary hearing. To this end the reviewer may, among other things: (a) Instruct the parties to: (i) Formulate and submit a list of genuine contested issues to be decided at the hearing; (ii) Identify each potential witness, the subject matter of each witness's testimony, and documents to be introduced; and (iii) Raise and address issues that can be decided before the hearing; (b) Encourage stipulations as to facts, law, and other matters; (c) Schedule dates for the submission of prefiled testimony, further prehearings, the hearing, and submission of briefs and documents; and (d) Rule on any pending motions. (4) A written summary of the prehearing conference shall be made a part of the record of the proceeding. (5) The reviewer may record the prehearing conference or have a stenographer present. (6) A request for the postponement of a hearing shall be made at a reasonable time before the hearing and may be granted only for good cause shown, at the discretion of the reviewer. D. List of Genuine Issues. (1) The reviewer shall establish a list of genuine issues of material fact for the evidentiary hearing. (2) An evidentiary hearing shall be held only on those genuine factual issues or issues on which the reviewer determines that testimony would be useful in rendering a decision. E. Written Direct Testimony. (1) Direct testimony shall be in writing and may not be delivered orally. (2) A party who wishes to present testimony at the evidentiary hearing shall file written testimony before the hearing in accordance with the schedule set by the reviewer. (3) The written direct testimony shall set forth the conclusions of the person submitting it and all arguments and facts supporting these conclusions. (4) Written direct testimony shall be verified either under oath at the hearing or by including the statement specified in Regulation .08B(2) of this chapter. (5) Upon notice with an opportunity to object, the reviewer shall separate irrelevant material from the remainder of the record and keep that material apart. Parts of the body of the written direct testimony judged irrelevant by the reviewer shall be so marked and may not be considered by the Commission in its deliberations. (6) Persons submitting written testimony shall make themselves available for oral cross-examination. Submitted application materials are also subject to cross-examination. Letters submitted into the record which are not considered written testimony are not subject to cross-examination. F. Cross-Examination. (1) Cross-examination of each witness shall be live and under oath. (2) The reviewer and each non-proponent applicant and interested party may conduct reasonable cross-examination of a witness who gave direct or rebuttal testimony. (3) The reviewer may set reasonable time limits on the cross-examination of witnesses. G. Rebuttal Testimony. (1) Rebuttal testimony is permitted on any issue specified by the reviewer. (2) Rebuttal testimony, whether specified by the reviewer to be written or oral, is subject to live cross-examination. H. Post-Hearing Briefs. The reviewer may request post-hearing briefs. I. Informal Proceedings. At the request of an applicant, and if each interested party waives the right to present evidence, argument, and conduct cross-examination, the reviewer may establish informal rules for mediation, structured negotiation, or another consensual procedure for reaching a decision. #### Regulation .12 Holder Responsibilities and Penalties for Noncompliance. *COMAR 10.24.01.12* A. Project Implementation Schedule. (1) An application for a CON or other Commission approval shall propose a schedule for implementation of the project that specifies the estimated time for, at a minimum, the following project implementation steps: (a) The time required to enter a binding obligation following Commission approval of the application for the project; (b) The time required to initiate construction, renovation, or both following execution of a binding obligation; (c) The time required to complete the approved construction, renovation, or both following initiation of construction, renovation, or both; and (d) The time required to place the new facility or modified facility in operation following the completion of approved construction, renovation, or both. (2) The proposed project implementation schedule for a project requiring a multiphased plan for implementation shall detail those multiple phases and specify the estimated time requirements for, at a minimum, the four time periods listed above for each phase. (3) A holder shall abide by the project implementation schedule submitted with its application for a CON or other Commission Approval. (4) The project implementation schedule may be reasonably modified by the holder during the period during which the project is being implemented with approval of Commission staff. B. Progress Report. (1) Up until an approved project’s completion, licensure, if required, and first use, a holder shall submit a semiannual progress report in the form and manner prescribed by Commission staff. (2) The semiannual progress report shall detail the holder’s compliance with the project implementation schedule and any conditions on approval imposed by the Commission. (3) A holder shall submit the semiannual progress reports in accordance with the following schedule: (a) The first report shall be due at least 45 days before the 6-month anniversary of the final action awarding the CON or other Commission approval; and (b) Subsequent progress reports shall be due every 6 months after the due date of the prior report. C. Obligation. (1) Except as provided by §C(2) of this regulation, a holder shall obligate at least 51 percent of the approved capital expenditure for a project involving building construction, renovation, or both, as documented by a binding construction contract or equipment purchase order, within the following specified time periods: (a) An approved new hospital has up to 36 months to document the required obligation; (b) A project involving an approved new non-hospital health care facility or involving a building addition or replacement of building space of a health care facility has up to 24 months to document the required obligation; (c) A project limited to renovation of existing building space of a health care facility has up to 18 months to document the required obligation; and (d) A project that does not involve construction or renovation shall document that the approved project is complete and operational within 18 months of project approval. (2) In a multiphased plan of construction with more than one construction contract approved for an existing health care facility, a holder has: (a) Up to 12 months after approval to obligate 51 percent of the capital expenditure for the first phase of construction; and (b) Up to 12 months after completion of the immediately preceding phase of construction to obligate 51 percent of the capital expenditure for any subsequent approved phase of construction. D. Effective Date of a CON or other Commission approval. The effective date of a CON or other approval is the date of Commission action approving the application for the project. If a request for reconsideration is timely filed under Regulation .19 of this chapter, the effective date of the approval is the date the Commission rules on the request. The filing of a notice of appeal does not stay enforcement of the Commission decision. E. Enforcement. The Commission may impose financial penalties, withdraw a CON or other Commission approval, or both, if it finds that: (1) The person who obtained Commission approval made a material misrepresentation upon which the Commission relied in approving the application or issuing first use approval; (2) The holder failed to demonstrate sufficient progress in implementing the project; (3) The holder has failed to obligate or complete an approved project as required by §A of this regulation; (4) The person who obtained Commission approval failed to meet a condition on the approval; (5) The holder failed to timely provide the semiannual progress report required under §B of this regulation; (6) The project differs materially from that approved by the Commission, including failure to timely seek approval of a project change in accordance with Regulation .17 of this chapter; or (7) The holder failed to obtain approval under Regulation .18 of this chapter prior to first use of any portion of a facility or service developed under a CON or other Commission approval. F. Financial Penalties. (1) Financial penalties imposed in accordance with this regulation may not exceed: (a) $100 per day for each day the violation continues for failure to timely provide a semiannual progress report; or (b) 1 percent of the approved budget for any other violation. (2) The Commission shall consider the following factors in determining the amount of any financial penalty: (a) The willfulness of the improper conduct; (b) The extent of actual or potential public harm caused by the violation; (c) The cost of investigation; (d) The holder’s prior record of compliance; (e) The budget approved in the CON or other Commission approval; (f) The holder’s ability to pay; and (g) If applicable, the amount of any unapproved capital cost increase that exceeds the approved budget. G. Notice Before Enforcement Action. (1) If Commission staff determines that a CON or other Commission approval should be withdrawn or financial penalties should be imposed, Commission staff shall inform the holder and each appropriate local health department, setting forth in writing the reasons for the proposed action. (2) This notice shall set forth the right of the holder to submit written argument in support of its position and present oral argument to the Commission, as well as the right to an evidentiary hearing conducted in accordance with Regulation .11 of this chapter, to show cause why the approval should not be withdrawn or financial penalties should not be imposed. (3) A holder that has failed to demonstrate sufficient progress in project implementation shall show good cause for the lack of progress. H. Final action by the Commission imposing financial penalties or withdrawing a CON or other approval shall: (1) Be in writing; (2) Include findings of fact and conclusions of law; and (3) Be transmitted to the holder and to each appropriate local health department within 30 days of the date of action by the Commission. I. CON Application after Withdrawal of a Prior CON. If a CON or other approval is withdrawn due to lack of sufficient progress in implementing the project, the holder may file an application seeking Commission approval to initiate or complete the previously authorized project, which shall be considered a new application by the Commission. #### Regulation .13 Procedures for Certificate of Conformance and Certificate of Ongoing Performance Applications. *COMAR 10.24.01.13* A. Coverage. (1) A certificate of conformance is required to introduce primary or elective percutaneous coronary intervention services at a hospital. (2) A certificate of ongoing performance is required and shall be periodically renewed to certify that a hospital providing cardiac surgery services or percutaneous coronary intervention services is maintaining an acceptable level of quality and performance in its provision of those services. (3) A hospital with newly established cardiac surgery services or percutaneous coronary intervention services at an acute general hospital may continue to provide services without a certificate of ongoing performance until the Commission acts on the hospital’s first application for a certificate of ongoing performance. B. Submission of Applications. (1) An application for a certificate of conformance or a certificate of ongoing performance shall be submitted to the Commission in a form and manner prescribed by the Commission. (2) An application shall be submitted in accordance with a published review schedule established by the Commission under §E of this regulation, except that applications to establish both primary and elective percutaneous coronary intervention services based on insufficient access under COMAR 10.24.17.04A(2)(b) may be filed at any time. (3) The application, and all information supplementing the application, shall be signed by at least one principal of the applicant, who shall sign a statement as follows: “I solemnly affirm under penalties of perjury that the contents of this application are true to the best of my knowledge, information, and belief.” C. Completeness Review of Certificate of Conformance Applications. (1) Commission staff shall review a certificate of conformance application for completeness within 15 business days. (2) If staff determines the application is not complete, staff may request additional information to make the application complete within the 15-business-day period to review the application. The applicant shall provide full and clear responses to the completeness and additional information request within 15 business days unless an extension is requested and granted. (3) If Commission staff determines after review of the application and information provided in response to staff’s request that the application is complete, staff shall notify the applicant of its determination. (4) If an applicant fails to supply requested information within the specified time limit, staff may dismiss and return the application. D. Additional Information. Commission staff may: (1) Request information from an applicant supplementing an application at any time during the review of an application, provided that such additional information is material to the determination of whether the applicant has satisfied the criteria and standards for approval; and (2) Set reasonable time limits for the applicant to supply the requested information. E. Notice to the Public. (1) At least once each year, the Commission staff shall publish in the Maryland Register a schedule for reviews of: (a) Certificate of conformance applications to establish primary or elective percutaneous coronary intervention services; and (b) Certificate of ongoing performance applications if at least one hospital is required to file an application in the time period covered by the schedule. (2) The Commission shall publish, on its website, information on the receipt of applications for certificates of conformance and certificates of ongoing performance. F. The Commission shall act on an application for a certificate of conformance not later than 120 days after staff notified the applicant that the application is complete, except for applications reviewed in conjunction with a CON application in accordance with COMAR 10.24.17.04C. G. Criteria for Review of Applications. Applicable criteria and standards for certificate of conformance reviews and certificate of ongoing performance reviews are specified in COMAR 10.24.17, the State Health Plan chapter for cardiac surgery and percutaneous coronary intervention services. H. Staff Report and Recommendation. Commission staff shall review a certificate of conformance and certificate of ongoing performance applications and prepare a staff report and recommendation that contains the staff’s conclusion as to whether the applicant has met each applicable criterion and standard in COMAR 10.24.17. I. Exceptions. (1) An applicant may submit exceptions to a staff report and recommendation and present oral argument on its exceptions to the Commission. (2) Schedule. (a) Staff’s issuance of a staff report and recommendation shall be accompanied by a notice that specifies the schedule for the submission of exceptions and the date of the Commission meeting at which the Commission shall hear oral argument on exceptions. (b) Unless otherwise agreed by each applicant and interested party, the schedule issued by Commission staff shall specify that: (i) A party filing exceptions has at least 10 days to file exceptions; and (ii) A party filing a response to exceptions has at least 7 days to file a response. (c) The Commission staff may shorten these periods by agreement of the parties, or extend any deadlines set for good cause shown. (3) Exceptions shall specifically identify each staff conclusion to which exception is taken, citing those portions of the record on which each exception is based. (4) Exceptions and any response to exceptions shall be limited to 25 pages, double-spaced, excluding attachments. (5) Commission staff may file a written response to exceptions and present oral argument at the exceptions hearing. (6) Oral arguments on exceptions to the staff report and recommendation and any response shall be limited to 10 minutes per argument unless extended by the Chair of the Commission. J. Final Decision on an Application for Certificate of Conformance. (1) A final decision on an application for a certificate of conformance shall contain findings of fact and conclusions of law and shall: (a) Approve the application; (b) Approve the application with conditions; or (c) Deny the application. (2) A certificate of conformance issued by the Commission for an approved application shall specify the period of time for which the initial certificate is effective and the expected date by which the hospital is expected to seek a certificate of ongoing performance for its primary or elective percutaneous coronary intervention services or both. K. Final Decision on an Application for Certificate of Ongoing Performance. (1) The Commission's final decision on an application for a certificate of ongoing performance shall contain findings of fact and conclusions of law and shall: (a) Approve the application; (b) Approve the application with conditions; or (c) Deny the application or revoke the Commission’s approval for the involved services provided that all the steps in COMAR 10.24.17 including performance of a focused review and an opportunity for agreement upon and completion of a plan of correction have been provided to the hospital. (2) A certificate of ongoing performance issued by the Commission shall specify the period of time for which the certificate is effective and the expected date by which the hospital is expected to seek a new certificate of ongoing performance for its primary or elective percutaneous coronary intervention services or both, as applicable, or for its cardiac surgery services. (3) The duration of a certificate of ongoing performance may be extended beyond the renewal deadline, if due to extenuating circumstances, the Executive Director determines an extension is necessary and appropriate, prior to staff producing a written report and recommendation to the Commission regarding the hospital’s application for renewal of its certificate of ongoing performance. L. The decision of the Commission shall be by a majority of the quorum present and voting. M. The decision of the Commission is subject to judicial review in accordance with Regulation .09F of this chapter. #### Regulation .14 Special Procedures. *COMAR 10.24.01.14* A. Determination of Coverage. Except as otherwise provided in Regulations .03 or .05 of this chapter, a project that requires a determination of coverage shall be dealt with in the following manner: (1) A written request for determination of coverage shall be filed with the Center for Health Care Facilities Planning and Development. (2) The Executive Director of the Commission shall review the request and act on it within 30 business days of receipt of complete information. (3) The person requesting the determination shall provide all additional information requested by Commission staff. (4) The Commission shall notify the person, each appropriate local health department, and each agency responsible under the Department's licensure program for the type of project whether it requires a Certificate of Need or other Commission review. (5) Commission staff’s determination of coverage may be appealed by the requesting party to the Commission by use of a motion filed in accordance with Regulation .10C of this chapter. (6) The Executive Director may issue a determination that: (a) Certificate of Need or other Commission review is not required; or (b) Certificate of Need review is required for stated reasons. B. Declaratory Rulings. (1) A person uncertain as to how a statute or regulation enforced by the Commission applies to that person or that person’s property may file with the Commission a petition for a declaratory ruling in accordance with the procedures in §B of this regulation. (2) The Commission may decline to issue a declaratory ruling for any of the following reasons: (a) The petition is not in accordance with this section; (b) The petition contains insufficient factual or legal information upon which to base a declaratory ruling; (c) The petition raises issues adequately addressed in a final decision or regulation of the Commission; (d) The petition fails to pose a significant issue; (e) The petition is properly heard as part of an evidentiary hearing; or (f) A declaratory ruling would not be in the public interest. (3) Within 15 days of receipt of a petition, the Executive Director shall either assign the petition to the full Commission for a decision or appoint a Commissioner to make a proposed ruling on the petition, which ruling shall be considered by the full Commission. (4) Within 45 days, or by the second regularly scheduled Commission meeting following the filing of the petition, whichever is later, the Commission shall rule or decline to rule on the petition, or may postpone issuing a formal written declaratory ruling for up to 35 days. (5) To secure a declaratory ruling, an affected person shall submit a petition for a declaratory ruling that contains the following information: (a) The petitioner's name, address, and telephone number; (b) A one or two sentence statement of each question on which a ruling is requested; (c) A one or two sentence summary of the petitioner's position on each question; (d) Citation to each provision that the Commission needs to interpret in order to answer each question posed; (e) A brief statement of each relevant fact; (f) The petitioner's factual, legal, and policy arguments, referring to documents, affidavits, data, and other relevant information, which shall be appended to the petition, unless the documents are readily accessible to the Commission; and (g) A statement by the petitioner under penalties of perjury that each fact recited as relevant to the question posed is true to the best of the petitioner's knowledge, information, and belief. (6) The Commission shall promptly publish notice of the receipt of a petition in the Maryland Register and shall note the petition on meeting agendas until the Commission acts upon the petition. (7) The Commissioner making a proposed ruling or the Commission, in addition to considering the materials submitted by the petitioner and comments from staff, may: (a) Request and receive oral or written statements from any person; (b) Consider any document, data, study, or other relevant material; or (c) Require argument on the question on the record, giving the petitioner the opportunity to present argument and to proffer witnesses and documents for the Commission's consideration. (8) The proposed and final declaratory ruling shall be in writing, and state: (a) Each question addressed; (b) The proposed or final ruling; and (c) The factual and legal basis for the ruling. (9) A final declaratory ruling binds the Commission and the petitioner on the facts set forth in the petition, except when this binding effect violates the due process rights of a competing applicant in a comparative review. (10) The Commission may revoke, alter, or amend a proposed or final declaratory ruling, which may have prospective effect only. (11) A petitioner may appeal the declaratory ruling as set forth in State Government Article, Title 10, Annotated Code of Maryland. #### Regulation .15 Commission Approval Required Before Certain Actions. *COMAR 10.24.01.15* A. Obligation of Capital Expenditure. (1) A person may not incur an obligation for a capital expenditure for a project that is subject to review under these regulations until the applicant receives a CON or other required Commission approval. (2) An obligation for capital expenditure is incurred by or on behalf of a health care facility: (a) When a contract, enforceable under State law, is entered into by or on behalf of the health care facility for the construction, acquisition, lease, or financing of a capital asset; (b) When a governing body of the health care facility takes formal action to commit its own funds for a construction project undertaken by the health care facility as its own contractor; or (c) In the case of donated property, on the date on which the gift is completed under applicable State law. B. Obligation of Predevelopment Expenditures. An applicant proposing predevelopment expenditures requiring review under this chapter may not enter into a binding contract or other obligation for such activities until the applicant receives a CON or other required Commission approval. C. Binding Commitments for Financing. A binding arrangement or commitment for financing a project may not be entered into by an applicant until the applicant receives a CON or other required Commission approval for the project. #### Regulation .16 Voluntary Withdrawal of an Application. *COMAR 10.24.01.16* An applicant may voluntarily withdraw its application without prejudice prior to final action by the Commission on the application. Written notice of the withdrawal shall be submitted to the Commission through the Executive Director. A withdrawn application may be resubmitted at a later date as a new application. #### Regulation .17 Project Changes After Commission Approval. *COMAR 10.24.01.17* A. Filing of Request. A holder that desires to change a project that has received CON or other Commission approval shall submit a request for the proposed change and supporting documentation to the Commission, copying each local health department within the health planning region of the project and, in the case of a change in the location or address of a project involving construction of a new health care facility, to all health care facilities of that type located in the health planning region. B. Commission Approval Required Before Project Changes. Any of the following proposed changes that would place the project at variance with its CON or other approval issued under this chapter, including any condition placed on the approval, shall be reviewed by the Commission: (1) A significant change in physical plant design; (2) A capital cost increase that exceeds the approved capital cost inflated by an amount determined by applying the Hospital Capital Market Baskets published by IHS Markit in Health Care Cost Review or other guidance approved by the Commission and posted on the Commission website from the application submission date to the date of the filing of a request for a project change; (3) A change in the financing mechanisms of the project; or (4) A change in the location of the project. C. Impermissible Changes. The following proposed changes to an approved project require a new CON or other appropriate review and may not be considered by the Commission: (1) Changes in the fundamental nature of a facility or the services to be provided in the facility from those that were approved by the Commission; (2) Increases in the facility’s total bed capacity or operating room inventory; or (3) Changes in the medical service provided or approved. D. Commission Action. (1) Requested changes subject to review under §B of this regulation shall be reviewed by the Commission. (2) Within 5 days after the Commission’s receipt of a written request to change the address or location of an approved project, Commission staff shall arrange to publish notice of receipt of the change request in the Maryland Register and one newspaper of general circulation in the appropriate health planning region, shall post the notice on its website, and shall provide written notice of receipt of the change request to: (a) Each member of the General Assembly in whose district the relocation is planned; (b) Each member of the governing body for the jurisdiction in which the relocation is planned; and (c) The county executive, mayor, or chief executive officer, if any, in whose county or city the relocation is planned. (3) The Commission shall provide a written notification within 45 days of the Commission’s receipt of a complete change request that: (a) The proposed change is approved in whole or part and incorporated into a modified CON or other modified approval for the project with conditions as appropriate; or (b) The proposed change is denied, with explanation. #### Regulation .18 Review Required Before Licensing or First Use of Project. *COMAR 10.24.01.18* A. Request for First Use Review and Approval. Not fewer than 60 days but not more than 120 days before the first use of any portion of a facility or service developed under a CON or other Commission approval, the holder shall specify the anticipated date for first use and request in writing, through the Center for Health Care Facilities Planning and Development, a final review and first use approval. The request shall include: (1) Documentation of the final cost of the project; and (2) A description of any differences in physical plant design, space, or services in the finished project when compared with the description of the project reviewed and approved by the Commission. B. Action on Request. Within 30 days of receipt of all required information, Commission staff shall issue an approval for first use or a finding that the project does not conform to its CON or other Commission approval. Issuance of first use approval is not a new final decision concerning a CON and may not be appealed. C. Nonconformance with CON or Other Commission Approval. If the Executive Director finds that a project does not conform to its CON or other approval, the applicant may not proceed to licensure or first use until the Executive Director issues a written finding that the project conforms with its approval. Based on a finding that a project varies significantly from the project that was granted a CON or other approval, the Executive Director may invoke the full review process established in Regulation .04, Regulations .08—.10, and Regulation .13 of this chapter in order to reexamine the project. D. Duration of First Use Approval. First use approval remains in effect for 90 days. If a project is not put into use within that 90-day period, the holder shall reapply for first use approval. #### Regulation .19 Reconsideration Procedures. *COMAR 10.24.01.19* A. Request for Reconsideration. An aggrieved party may request that the Commission conduct a hearing to reconsider a Commission final decision to grant, to grant with conditions, or to deny a Certificate of Need application, a request for an exemption from CON review, or a certificate of conformance application issued under this chapter. This request shall be in writing and filed with the Center for Health Care Facilities Planning and Development within 15 days of the date upon which the Commission renders its decision and shall show good cause for reconsideration of the decision. B. Good Cause. For purposes of this regulation, a request for a reconsideration shows good cause if it: (1) Presents significant, relevant information which was not previously presented to the Commission and which, with reasonable diligence, could not have been presented before the Commission made its decision; (2) Demonstrates that there have been significant changes in factors or circumstances relied upon by the Commission in reaching its decision; or (3) Demonstrates that the Commission has materially failed to follow its adopted procedures in reaching its decision. C. Notice of Reconsideration Request. At least 15 days prior to the date the Commission will consider a request for reconsideration, the Commission shall provide written notice of the date to the person making the request, each applicant, each interested party, and each relevant local health department. Each interested party may file a written response. D. A request to present oral arguments shall be made at the time of filing an initial request for reconsideration or a response. E. If the Commission determines that good cause has been demonstrated, the Commission may reverse or modify its previous decision. Within 30 days, the Commission shall issue a new decision containing written findings of fact and conclusions of law stating the basis for its decision, which shall be its final decision for the purpose of judicial review. #### Regulation .20 Emergency Certificate of Need. *COMAR 10.24.01.20* A. The Executive Director may issue an emergency Certificate of Need under the following circumstances that would otherwise require issuance of a CON: (1) A situation presents hazards to employees or patients of a health care facility, and the project required to address the situation would otherwise require CON review; (2) The closing of a health care facility by State licensing authorities requires changes or adjustments in other facilities to accommodate displaced patients, and the changes or adjustments would otherwise require that these facilities obtain a CON under these regulations; or (3) A project that would require CON review is necessary to address a public health emergency and cannot be delayed. B. Procedure for an Emergency Certificate of Need. (1) A health care facility may apply for an emergency CON by sending a signed letter in PDF format by email and hard copy to the Executive Director that contains: (a) A description of the project for which an emergency CON is sought; (b) An explanation of the need for emergency action; (c) The location and current use of the space where the proposed project will be implemented; (d) The time frame by which the project can be implemented; (e) Approximate cost, if known; and (f) Status of existing unused physical bed space at the health care facility that could quickly be converted to inpatient or resident care to address the emergency. (2) The applicant shall timely provide additional information requested by Commission staff. C. Commission Action. (1) The Executive Director may grant or deny an emergency CON application after consultation with the Chair of the Commission and receipt of suitably detailed information from the applicable State licensing agency regarding the need for emergency action. If, upon receipt of this information, the Executive Director agrees that the project is needed to address an emergency situation, the Executive Director shall issue an emergency Certificate of Need. The issuance of an emergency CON shall be on the agenda of the next scheduled Commission meeting for confirmation by the Commission. (2) The Executive Director may exercise the discretion not to make a decision on an emergency CON application and refer the application for consideration by the Commission. If a quorum of the Commission agrees that the project is needed to address an emergency situation, the Commission shall issue an emergency Certificate of Need. D. Duration of Emergency Certificate of Need. The emergency CON is temporary and is valid for a period not to exceed 165 days. The duration of an emergency CON may be extended by the Executive Director for good cause shown by the applicant or at the request of the Secretary. E. A health care facility that desires to retain the capacity or project approved in an emergency CON shall, at least 30 days before the termination of the emergency CON, file a letter of intent followed by a CON application in accordance with the provisions in Regulation .08 of this chapter for an unscheduled review. The normal review process and time period set forth in this chapter apply to the review of a CON application filed after issuance of an emergency CON. This filing deadline may be extended by the Executive Director. The duration of an emergency CON shall be extended automatically during any period of time when the applicant has properly and timely sought a CON to retain the capacity or project approved on an emergency basis. F. Review of Denied Application. In the event the Executive Director denies an application for an emergency CON, the applicant may submit a written request for Commission review of the decision within 15 days of the denial, stating with particularity the grounds and factual basis for the applicant’s disagreement with the Executive Director’s decision. The Commission shall make a decision on the request for review within 45 days of the request. #### Regulation .21 Acquisitions of Nursing Homes. *COMAR 10.24.01.21* A. Notice of Transfers of Ownership. (1) A person shall provide notice to the Commission at least 30 days before the change of ownership of a nursing home, including changes in ownership of real property and improvements, bed rights, or operatorship, that: (a) Involves at least a 5 percent transfer in ownership interest; and (b) Is not an acquisition that requires approval under §B of this regulation. (2) The notice required by §A(1) of this regulation shall be in a form required by the Commission and include: (a) A description of the change in ownership interest; (b) Complete organizational charts for all persons holding at least a 5 percent ownership interest in the nursing home prior to and following the proposed transfer; (c) An attestation that the change does not require approval under §B of this regulation; and (d) Any other information requested by the Commission. B. Request for Acquisition Approval. (1) Applicability. (a) This section does not apply to an acquisition that: (i) Involves only changes of ownership interests among existing owners of a nursing home; or (ii) The Commission has exempted from these requirements in accordance with COMAR 10.24.20.06A(3). (b) This section applies to: (i) Transfers of stock or assets of the owner of the real property and improvements, bed rights, or operation of the nursing home, or any combination thereof; (ii) An affiliation agreement between non-profit entities that changes the person who controls a nursing home’s operation or assets; and (iii) A lease agreement that changes the person who controls a nursing home’s operation or assets. (2) At least 60 days before closing on an acquisition of a nursing home, a person shall: (a) Submit to the Commission a request for acquisition approval in a form prescribed by the Commission; and (b) Provide notice, in the form prescribed by the Commission, to the residents, resident representatives, and employees of the nursing home that: (i) The request for acquisition approval was submitted to the Commission; and (ii) They have the right to submit comments. (3) Notice by the Commission to the Public, and Other State Agencies. Within 5 days after it receives a complete request for acquisition approval, the Commission shall: (a) Submit notice of its receipt and the deadline for residents, resident representatives and employees of the nursing home to submit comments on the proposed acquisition: (i) To at least one newspaper of general circulation in the affected area; (ii) To be published in the next available issue of the Maryland Register; and (iii) On the Commission’s website; and (b) Provide notice of the request to: (i) The Secretary or the Secretary’s designee; (ii) The Office of the Attorney General; (iii) The Secretary of Aging; and (iv) The State Long-Term Care Ombudsman Program. C. Executive Director Action. (1) The Executive Director shall review a request for acquisition approval within 45 days after receiving the completed request from the applicant. (2) The Executive Director, in consultation with the Secretary or the Secretary’s designee, may: (a) Approve the acquisition; (b) Approve the acquisition with conditions; (c) Deny the acquisition; or (d) Refer the request for acquisition approval to the Commission for a final decision. (3) To approve a request for acquisition approval, the Executive Director must find that the acquisition: (a) Is consistent with COMAR 10.24.20, the State Health Plan chapter for Comprehensive Care Facility (Nursing Home) Services; and (b) Is in the public interest. (4) In determining whether an acquisition of a nursing home is in the public interest, the Executive Director shall: (a) Consider comments from individuals who: (i) Reside in the nursing home; (ii) Have family members who reside in the nursing home; or (iii) Are employed as employees of the nursing home; (b) Consult with the Attorney General on whether the acquisition raises public interest concerns. D. Commission Action. If the Executive Director refers a request for acquisition approval to the Commission under §C(2)(d) of this regulation , the Commission shall use the criteria specified in §C(3) and (4) of this regulation to make a final decision within 60 days after receiving the completed request from the applicant. E. The Commission shall promptly send a copy of the decision of the Executive Director or Commission on a request for acquisition approval to the Secretary, the Secretary of Aging, the Office of Health Care Quality, the Office of the Attorney General, and the State Long–Term Care Ombudsman. F. Appeal. (1) Commission Review of Executive Director Decision. (a) A person who is a party to the acquisition may seek Commission review of an Executive Director’s decision denying the request or imposing a condition on approval. (b) A request for review of an Executive Director’s decision: (i) Shall be filed within 15 days after the issuance of a decision; (ii) Shall specifically identify each finding and conclusion to which review is requested; and (iii) May include a request for oral argument. (c) The Commission shall review the Executive Director’s decision within 45 days of the request for review. (2) Judicial Review. (a) A decision of the Commission under §D or §F(1) of this regulation shall be a final decision for the purpose of judicial review. (b) A person that is a party to the acquisition may take a direct judicial appeal within 30 days after the Commission makes the final decision. G. Annual Reports. (1) On or before July 1 immediately following the acquisition of a nursing home and each year for 3 years thereafter, the person that acquired the nursing home shall submit a report to the Commission in accordance with COMAR 10.24.20. (2) The Commission shall provide a copy of the report required under §G(1) of this regulation to the Secretary, the Secretary of Aging, the Office of Health Care Quality, the Office of the Attorney General, and the State Long–Term Care Ombudsman. #### Regulation .22 Severability. *COMAR 10.24.01.22* If any provision of this chapter is declared void by a court of law, the remainder of this chapter shall be unaffected and of continued force and effect. #### Regulation .23 Effective Date. *COMAR 10.24.01.23* A. A letter of intent or application submitted after the effective date of these regulations is subject to their provisions. B. A request for a determination of coverage under Regulation .14A of this chapter, submitted after the effective date of these regulations, is subject to the provisions of this chapter. C. Upon request by a holder, a project that has previously received a Certificate of Need or other Commission approval may be governed by this chapter. D. Pending Reviews. (1) Except in contested or comparative CON reviews, an application for a CON or other Commission approval pending at the time these regulations become effective shall be subject to their provision upon request of the applicant. (2) Upon request of an applicant for a CON in a contested or comparative review, an application pending at the time these regulations become effective may be subject to their provisions with the consent of all interested parties and upon a finding of good cause by the reviewer. (3) If the applicable CON review criteria have materially changed as a result of these regulations, the application of these regulations to a pending CON application shall be deemed a modification and governed by Regulation .08E of this chapter. ### Chapter 02 — Data Reporting by Hospitals **Authority:** Health-General Article, §19-101 et seq., Annotated Code of Maryland **Administrative History:** Effective date: November 14, 1980 (7:23 Md. R. 2167) **Administrative History:** Chapter revised effective January 1, 1983 (9:9 Md. R. 904) **Administrative History:** Regulations .01 — .06, Submission of Certain Data to the Agency, repealed effective October 15, 1990 (17:20 Md. R. 2428) **Administrative History:** Regulations .01 — .05, Data Reporting by Hospitals, adopted effective October 15, 1990 (17:20 Md. R. 2428) **Administrative History:** Regulation .01B amended effective February 28, 2005 (32:4 Md. R. 410) **Administrative History:** Regulation .02 amended effective February 28, 2005 (32:4 Md. R. 410) **Administrative History:** Regulation .03C amended effective February 28, 2005 (32:4 Md. R. 410) **Administrative History:** Regulation .04 amended effective February 28, 2005 (32:4 Md. R. 410) #### Regulation .01 Definitions. *COMAR 10.24.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Commission” means the Maryland Health Care Commission. (2) “Hospital” means a facility defined as a hospital in Health-General Article, §19-301(e) and (g), Annotated Code of Maryland, and COMAR 10.07.01 including: (a) All classifications of institutions set forth in Health-General Article, §19-307, Annotated Code of Maryland, and COMAR 10.07.01, including “general”, “special”, or other types of hospitals specified by rule or regulations pursuant to Health-General Article, §19-307, Annotated Code of Maryland; (b) “Special rehabilitation” hospital, as set forth in Health-General Article, §19-318, Annotated Code of Maryland, and COMAR 10.07.01; and (c) “Limited service” hospital, as set forth in Health-General Article, §19-307.1, Annotated Code of Maryland, and COMAR 10.07.17. (3) “HSCRC” means the Health Services Cost Review Commission. #### Regulation .02 Collection and Reporting of Hospital Data. *COMAR 10.24.02.02* A. Hospitals shall submit accurate, timely, and complete data which the Commission deems necessary for development of methodologies, planning, analysis, and Certificate of Need reviews as requested on a periodic basis. B. The information requested by and to be reported to the Commission may include, but is not limited to, the following types of information: (1) Aggregate facility data: (a) Types of services offered; (b) Licensed and operating hospital beds; (c) Utilization data; and (d) Staffing; (2) Patient-specific data: (a) Admission, discharge, and disposition data; (b) Demographic characteristics; (c) Patient residence data; (d) Medical diagnosis and treatment data; (e) Surgical and diagnostic procedure data; (f) Attending and operating physicians; and (g) Revenue data, including actual or expected source of payment; and (3) Data that are needed by the Commission to perform the duties described in Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland, and that are not set forth in COMAR 10.37.04, 10.37.06 or 10.37.07. C. Except as provided in §B(3) of this regulation, the Commission shall deem a hospital which reports data to the HSCRC to be in compliance with these regulations if it submits the information required by COMAR 10.37.04, 10.37.06 or 10.37.07 in full and within the time period set forth in those chapters. D. The Commission shall deem a State psychiatric hospital to be in compliance with these regulations if it submits the information required by COMAR 10.37.06 for private psychiatric hospitals under the jurisdiction of HSCRC. E. A hospital which does not come within the jurisdiction of HSCRC, is not required to report full patient specific data to HSCRC, as set forth in COMAR 10.37.04, 10.37.06, or 10.37.07, or is required to report data as provided in §B(3) of this regulation, shall submit to the Commission a complete response to its data request within 60 days of the last day of the time period covered by the request, or within 60 days of receipt by the hospital of a data request from the Commission, whichever is longer. F. The Commission shall specify the form and format of any hospital data submission requested under §§D and E of this regulation. G. Exemptions. (1) A hospital reporting under §§D and E of this regulation may request an exemption from the Commission's data request. (2) A request for an exemption shall be submitted in writing to the Executive Director of the Commission not later than 30 days before a submission is due, identifying the specific data element or elements for which an exemption is requested and explaining the reasons for the exemption request. (3) The Executive Director shall send a response to the request for an exemption to the hospital within 10 days of receipt by the Commission. #### Regulation .03 Extensions. *COMAR 10.24.02.03* A. A hospital may request an extension of its submission date by letter to the Executive Director of the Commission submitted not later than 15 days before a submission is due, explaining the reason for the extension and a requested due date. B. The Executive Director shall send a response to the request for an extension to the hospital within 10 days of receipt by the Commission. C. Except as provided in Regulation .02B(3) of this chapter, for hospitals meeting the requirements of Regulation .02C of this chapter, extensions obtained in accordance with procedures established by HSCRC shall be deemed in compliance with this chapter. #### Regulation .04 Sanctions. *COMAR 10.24.02.04* Any hospital which fails to submit the information set forth in this chapter within the required time frame, in the absence of an extension granted by the Commission or HSCRC, may be subject to penalties as described in COMAR 10.25.12. #### Regulation .05 Summary Studies, Reports, and Compilations. *COMAR 10.24.02.05* Summary studies, reports, or other compilations developed by the Commission or its staff from the data submitted in accordance with this chapter shall be public information, except that disclosure may not be made in such a way that the data furnished for a specific patient can be identified. ### Chapter 03 — Maryland Long-Term Care Survey **Authority:** Health-General Article, §§19-109(a)(1) and (7) and 19-116(b)(1) and (2), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Chapter 03 “Statewide Nursing Home Survey for 1981” effective May 10, 1982 (9:9 Md. R. 905); repealed effective March 11, 1985 (12:5 Md. R. 483) **Administrative History:** Chapter 03 "1984 Maryland Long Term Care Survey" adopted effective March 11, 1985 (12:5 Md. R. 483) **Administrative History:** Chapter revised effective February 9, 1987 (14:3 Md. R. 273) **Administrative History:** Regulations .01B and .02B, C amended and Regulations .03 and .04 adopted as an emergency provision effective March 1, 1993 (20:6 Md. R. 578); emergency status expired June 28, 1993 **Administrative History:** Regulation .01B amended effective July 5, 1993 (20:13 Md. R. 1049); August 16, 2004 (31:16 Md. R. 1255) **Administrative History:** Regulation .02 amended effective August 16, 2004 (31:16 Md. R. 1255) **Administrative History:** Regulation .02B, C amended effective July 5, 1993 (20:13 Md. R. 1049) **Administrative History:** Regulation .02D amended effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Regulations .03 and .04 adopted effective July 5, 1993 (20:13 Md. R. 1049) #### Regulation .01 Definitions. *COMAR 10.24.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Long-term care providers” means providers of institutional and community-based, long-term care services, including those providers identified in COMAR 10.24.08. (2) “Maryland Long-Term Care Survey” means any written request for data from the Maryland Health Care Commission to long-term care providers. This data may include: (a) Types of services offered; (b) Operating policies and limits on operations; (c) Revenue data; (d) Cost data; (e) Changes in licensed capacity; (f) Utilization data; (g) Patient/client-specific data including: (i) Demographic data; (ii) Admission and discharge data; (iii) Reimbursement data; and (iv) Diagnostic and functional data. #### Regulation .02 Collection and Submission of Data. *COMAR 10.24.03.02* A. Long-term care providers, on a periodic basis as requested, shall submit accurate, timely, and complete data required by the Commission for: (1) The development of methodologies and planning; and (2) Maintenance of the nursing home performance evaluation guide. B. The Commission shall: (1) Annually survey providers of comprehensive care, extended care, chronic hospital care, and assisted living; and (2) Prepare a schedule for surveying other long-term care providers. C. Providers shall retain a listing of all patient/client codes, as applicable, and a copy of the survey for 5 years to permit the Commission to follow up on unclear responses. D. Long-term care providers shall prepare and submit to the Commission within 60 days of receipt of the survey instrument, data responses to the Maryland Long-Term Care Survey. Failure to submit these responses in a timely fashion may subject the provider to penalties as described in COMAR 10.25.12. E. A survey required under this regulation does not replace any existing data requirements of the Department or any agencies or commissions of the State. #### Regulation .03 Extensions. *COMAR 10.24.03.03* A. A long-term care provider may request an extension of its submission date, by letter, to the Executive Director of the Commission, if the request: (1) Is submitted not later than 15 days before the submission is due; (2) Explains the reason for the extension; and (3) Provides a requested due date. B. The Executive Director shall send a response to the request for an extension to a long-term care provider within 10 days of receipt of the request by the Commission. #### Regulation .04 Summary Studies, Reports, and Compilations. *COMAR 10.24.03.04* Summary studies, reports, or other compilations developed by the Commission or the Commission's staff, from the data submitted in accordance with this chapter, is public information, except that disclosure may not be made in such a way that the data furnished for a specific patient/client can be identified. ### Chapter 04 — Freestanding Ambulatory Surgical Facilities Survey **Authority:** Health-General Article, §§19-109(a)(1) and 19-116(b)(1) and (2), Annotated Code of Maryland **Administrative History:** Effective date: November 14, 1980 (7:23 Md. R. 2167) **Administrative History:** Regulations .01 and .02, Statewide Hospital Data Survey for 1980, repealed effective April 6, 1987 (14:7 Md. R. 831) **Administrative History:** Regulations .01 and .02, Freestanding Ambulatory Surgical Facilities Survey, adopted effective April 6, 1987 (14:7 Md. R. 831) **Administrative History:** Regulation .01 amended effective January 15, 1996 (23:1 Md. R. 25) **Administrative History:** Regulation .02 amended effective January 15, 1996 (23:1 Md. R. 25) **Administrative History:** Regulation .02C amended effective December 23, 2002 (29:25 Md. R. 1982) #### Regulation .01 Definitions. *COMAR 10.24.04.01* A. “Freestanding ambulatory surgical facilities” means facilities or offices which operate primarily for the purpose of providing surgical services to patients not requiring overnight hospitalization, and which are required to obtain a license under Health-General Article, §19-3B-02(a), Annotated Code of Maryland, including: (1) A center, service, office, facility, or office of one or more health care practitioners or a group practice, as defined in Health Occupations Article, §1-301, Annotated Code of Maryland, that provides ambulatory surgical services in two or more operating rooms, or in one operating room where the providers receive a technical or facility fee; (2) An existing ambulatory surgical facility or office of one or more health care practitioners that has received a Certificate of Need or a determination of exemption from Certificate of Need coverage from the Maryland Health Resources Planning Commission; (3) Medicare-certified ambulatory surgical facilities; (4) Hospital-affiliated ambulatory surgical facilities that are not subject to the Health Services Cost Review Commission's ambulatory surgery survey set forth in COMAR 10.37.07; and (5) Ambulatory surgical facilities owned by or affiliated with health maintenance organizations. B. “Freestanding ambulatory surgical facilities survey” means any written request for data from the Maryland Health Resources Planning Commission to freestanding ambulatory surgical facilities. This data may include: (1) The name and address of the entity providing ambulatory surgical services, and the location where these services will be provided; (2) The number of operating rooms at the location; (3) The names of persons or organizations which have an ownership interest in the entity, and their officers, directors, partners, and owners; (4) The names of any other ambulatory surgical facilities in which individuals listed in response to §B(3) of this regulation have an interest or other economic relationship, as an officer, director, partner, member, or owner; (5) A listing of any other ambulatory surgical facilities at the same address; (6) Contractual relationships to provide ambulatory surgical services between the entity and other health care facilities or health care providers who are not employees of the entity, or exercise only medical practice privileges at the location; (7) The names and specialties of the health care practitioners who provide surgical services at the location and the types of procedures performed there; (8) Cost, charge, and reimbursement data, including the amount of care reimbursed by Medicaid, Medicare, and other third-party payors, and the amount of uncompensated care provided by the entity; (9) Utilization data, including types of procedures; (10) Operating policies, including hours of operation; (11) Patient-specific or patient aggregate data, including demographic data, data on reimbursement source and levels, on types of procedures, and on patient disposition; and (12) Staffing requirements and patterns. #### Regulation .02 Collection and Submission of Data. *COMAR 10.24.04.02* A. All freestanding ambulatory surgical facilities shall submit accurate, timely, and complete data required by the Commission for the development of methodologies and planning on a periodic basis as requested. B. If patient-specific data is requested, providers shall assign to each patient an identification number in a format specified by the Commission. Providers shall retain a listing of all patient identifier codes for 5 years to permit the Commission to follow up on unclear responses. C. All freestanding ambulatory surgical facilities shall prepare and submit to the Commission within the time frames specified in the survey instrument, and in a machine-readable format specified by the Commission, data responses to the freestanding ambulatory surgical facilities survey. Failure to submit these responses in a timely fashion may subject the facility to penalties as described in COMAR 10.25.12. If the respondent cannot provide the data within the specified time frames, a written request for extension shall be submitted to the Commission. D. The data requested from freestanding ambulatory surgical facilities in a survey required under this regulation shall be coordinated with the reporting requirements of the Health Care Access and Cost Commission to ensure that the survey is compatible with and does not duplicate information collected by the Health Care Access and Cost Commission. A survey required under this regulation does not replace any existing data requirements of the Maryland Department of Health or any agencies or commissions of the State. ### Chapter 05 — Continuation of Authority to Provide Non-Primary PCI Through Participation in the Follow-On C-PORT E Registry **Authority:** Health-General Article, §§19-101, 19-118, 19-120, and 19-120.1, Annotated Code of Maryland **Administrative History:** Effective date: October 22, 2007 (34:21 Md. R. 1915) **Administrative History:** Regulation .02C amended as an emergency provision effective April 11, 2009 (36:10 Md. R. 714); amended permanently effective July 16, 2009 (36:14 Md. R. 984) **Administrative History:** Chapter revised as an emergency provision effective March 23, 2011 (38:8 Md. R. 504); revised permanently effective June 13, 2011 (38:12 Md. R. 705) **Administrative History:** Regulation .04A amended effective October 17, 2011 (38:21 Md. R. 1278) **Administrative History:** Chapter revised effective March 4, 2013 (40:4 Md. R. 346) #### Regulation .01 Definitions. *COMAR 10.24.05.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Commission” means the Maryland Health Care Commission. (2) “C-PORT study” means the randomized clinical research trial that was conducted by the Atlantic Cardiovascular Patient Outcomes Team (C-PORT) to determine whether nonprimary PCI performed in hospitals without on-site cardiac surgery services is as safe and effective as nonprimary PCI performed in hospitals with on-site cardiac surgery services. (3) “Nonprimary percutaneous coronary intervention” means PCI capable of relieving coronary vessel narrowing associated with coronary artery disease unrelated to ST-segment elevation myocardial infarction and includes elective PCI. (4) “Percutaneous coronary intervention (PCI)” means a variety of catheter-based techniques, including balloon angioplasty, capable of relieving coronary vessel narrowing. (5) “Primary PCI” means PCI capable of relieving coronary vessel narrowing associated with ST-segment elevation myocardial infarction (STEMI) and is also known as emergency PCI. (6) “Regional service area” means the area used for planning for cardiac surgery and PCI services, as provided in the State Health Plan, COMAR 10.24.17. (7) “Registry” means the C-PORT E Registry of Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI and that is: (a) Maintained by the Principal Investigator in the C-PORT E Study of Non-Primary PCI; (b) Overseen by the Johns Hopkins Institutional Review Board; (c) Overseen by a Data and Safety Monitoring Board. (8) “STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction. (9) “Waiver to perform nonprimary PCI” means a time-limited exemption from the requirements of COMAR 10.24.17.04E, Policy 5.0, by which the Commission permitted an acute care hospital without on-site cardiac surgery services to perform nonprimary PCI services within the C-PORT study. (10) “Waiver to perform primary PCI” means a time-limited exemption from the requirements of COMAR 10.24.17.04E, Policy 5.0, by which the Commission permits an acute care hospital without on-site cardiac surgery services to perform primary PCI services. #### Regulation .02 Purpose and Scope. *COMAR 10.24.05.02* A. In 2007, the Commission established a one-time process by which certain licensed acute general hospitals without on-site cardiac surgery services were awarded time-limited research waivers from the requirements of COMAR 10.24.17.04E, Policy 5.0, and were permitted to provide non-primary PCI services as part of the C-PORT E study to assess the safety and efficacy of providing non-primary PCI services for certain patient groups without on-site cardiac surgery, as provided in COMAR 10.24.17.04E, Policy 5.3. B. In 2007, the Commission determined that the C-PORT E study offered a means of acquiring information to support future evidence-based State health care policy and planning with regard to cardiovascular services. C. In 2011, after the C-PORT E research study concluded active enrollment, the Commission continued the research waiver of each hospital that was in good standing, thereby permitting each such hospital to continue to offer nonprimary PCI services while the required follow-up data on C-PORT E patients was collected and analyzed, provided that the hospital continued to perform non-primary PCI under the limitations and for the Registry term provided in prior regulations until such time as the Commission has the information from the research study that is needed to guide State policy about the regulation of non-primary PCI. D. Health-General Article, §19-120.1(d), Annotated Code of Maryland, effective July 1, 2012, provides that a certificate of conformance to establish a nonprimary PCI service is not required for a Registry hospital that the Commission determines, on or before December 31, 2012, continues to be in compliance with: (1) Commission regulations, including COMAR 10.24.17, Table A-1; and (2) The requirements of the Registry. E. The Commission has convened a clinical advisory group, in accordance with Health-General Article, §19-120.1(g)(3), Annotated Code of Maryland, that will offer advice to the Commission on the update of COMAR 10.24.17, the Cardiac Surgery and PCI Services Chapter of the State Health Plan. The analysis conducted as part of this update will review the C-PORT E study results, which were published in a peer-reviewed journal in March 2012 and will consider the system impact, including access, cost-effectiveness, and quality implications, of non-primary PCI being performed in hospitals without on-site cardiac surgery. F. Until the updated COMAR 10.24.17 is effective, each Registry hospital shall continue to meet each requirement in these regulations, including each requirement in the Registry’s manual of operations, in order to continue to provide nonprimary PCI. #### Regulation .03 Conditions for Maintaining Authority to Perform Nonprimary PCI and Participation in Registry. *COMAR 10.24.05.03* A. A Registry hospital shall maintain compliance with the following requirements: (1) A Registry hospital shall meet the criteria established in the manual of operations of the C-PORT E Registry of Non-Primary PCI that follows-on the C-PORT E Study of Non-Primary PCI; and (2) A Registry hospital shall continue to satisfy the following requirements: (a) For institutional resources: (i) Maintain a patient prioritization plan that guarantees that a patient who requires primary PCI for STEMI is given immediate preference for care in the cardiac catheterization laboratory; (ii) Maintain a formal and properly executed written agreement with a tertiary care center that provides for the unconditional transfer of each non-primary PCI patient who requires additional care, including emergent or non-primary cardiac surgery or PCI, from the applicant hospital to the tertiary institution; and (iii) Maintain its agreement with an advanced cardiac support emergency medical services provider that guarantees arrival of the air or ground ambulance at the applicant hospital within 30 minutes of a request for non-primary PCI patient transport by the applicant; (b) For physician resources, A Registry hospital shall maintain adequate staff necessary for the provision of primary and non-primary PCI services, including a minimum of three interventional cardiologists who: (i) Meet the requirements in the C-PORT E study research protocol and in COMAR 10.24.17, Table A-1; (ii) Can be available on-site within 30 minutes when on call; and (iii) Agree to abide by the Device Selection Criteria in the applicable Manual of Operations; (c) For minimum volumes, A Registry hospital shall maintain a minimum volume of 200 PCI procedures during each year of its waiver; (d) For follow-up of patients enrolled in the C-PORT E study, A Registry hospital shall maintain a patient follow-up rate of 98 percent; and (e) For follow-up of patients enrolled in the Registry, A Registry hospital shall commit to patient follow-up through hospital discharge. B. A Registry hospital shall notify the Commission in writing within 3 business days of the occurrence of any of the following: (1) The hospital performs non-primary PCI on a patient not enrolled in the Registry; (2) The hospital's primary PCI waiver expires, is relinquished, or is withdrawn; (3) The hospital fails to notify the Commission of the death of or a coronary artery bypass surgery experienced by a patient participating in the Registry; (4) The hospital fails to perform a minimum of 200 PCI procedures annually each year after it received a non-primary PCI research waiver from the Commission; or (5) The hospital fails to meet and maintain the criteria required by the Commission for participation in the Registry, or its participation in the Registry ends for any reason. C. A hospital required to give notice under §B of this regulation shall, on written notice from the Commission, immediately relinquish its authority to perform nonprimary PCI. #### Regulation .04 Term. *COMAR 10.24.05.04* A hospital’s ability to provide non-primary PCI [by virtue of the extension of its research waiver and entry into] in the Registry expires on the earlier of: A. The date upon which the Commission determines, through implementation in an update to COMAR 10.24.17 or other appropriate regulation, that the results of the C-PORT E study are sufficiently complete to guide public policy; B. A finding by the Commission that the C-PORT E study did not produce reliable results to guide public policy; or C. A finding by the Commission that the evidence is insufficient to change Policy 5.0 of COMAR 10.24.17.04E that requires non-primary PCI to be performed in hospitals with on-site cardiac surgery services. #### Regulation .05 Performance and Monitoring. *COMAR 10.24.05.05* A. Each Registry hospital shall provide data to the Commission in a form and manner acceptable to the Commission. B. Each Registry hospital shall submit periodic progress reports in a format specified by the Commission and, at the conclusion of the research project and, if requested, at the end of the Registry, submit final reports in a form and manner acceptable to the Commission, as provided in COMAR 10.24.17.05D(2)(d). C. Each Registry hospital shall authorize the C-PORT E study principal investigator and the Registry coordinator to provide data requested by the Commission. ### Chapter 06 — Data Reporting by Non-Hospital Health Care Facilities **Authority:** Health-General Article, §§19-109 and 19-116, Annotated Code of Maryland **Administrative History:** Effective date: October 23, 2006 (33:21 Md. R. 1675) **Administrative History:** Regulation .01B amended effective December 22, 2025 (52:25 Md. R. 1268) **Administrative History:** Regulation .02 amended effective December 22, 2025 (52:25 Md. R. 1268) **Administrative History:** Regulation .03 recodified from Regulation .04 effective December 22, 2025 (52:25 Md. R. 1268) **Administrative History:** Regulation .04 repealed effective December 22, 2025 (52:25 Md. R. 1268) #### Regulation .01 Definitions. *COMAR 10.24.06.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Commission” means the Maryland Health Care Commission. (2) “Non-hospital health care facility” means: (a) A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (b) An ambulatory surgical facility, as defined in Health-General Article, §19-114, Annotated Code of Maryland; (c) A facility providing intermediate care, as that term is defined in COMAR 10.24.01.01; (d) A home health agency, as defined in Health-General Article, §19-401, Annotated Code of Maryland; (e) A hospice, as defined in Health-General Article, §19-901, Annotated Code of Maryland; (f) A freestanding medical facility, as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland; (g) A comprehensive care facility, as defined in COMAR 10.24.01.01; and (h) Other non-hospital health institutions, services, or programs that may be specified as requiring a certificate of need under State law. #### Regulation .02 Collection and Reporting of Data. *COMAR 10.24.06.02* A. A non-hospital health care facility shall submit accurate, timely, and complete data which the Commission considers to be necessary for planning and analysis purposes, as requested by the Commission. B. The information requested by the Commission may include, but is not limited to, the following types of information: (1) Aggregate facility data as follows: (a) Service configuration; (b) Location; (c) Operational characteristics; and (d) Utilization; and (2) Patient-level data as follows: (a) Demographic characteristics; (b) Admission, discharge, and disposition data; (c) Diagnosis and treatment data; and (d) Payment source and charges. C. The Commission shall provide notice of the form, format, and schedule for data reporting by non-hospital health care facilities. D. Failure to report the data required under this regulation may subject a non-hospital health care facility to penalties under COMAR 10.25.12. E. The requirements of this chapter are in addition to any other obligation to report information to the Commission by law or as a condition on a certificate of need or other Commission approval. F. Extension. (1) A non-hospital health care facility, by letter to the Executive Director of the Commission, may request an extension of its data submission date. (2) The Executive Director of the Commission, for good cause shown, may grant an extension of a data submission date. #### Regulation .03 Summary Studies, Reports, and Compilations. *COMAR 10.24.06.03* A. Subject to §B of this regulation, summary studies, reports, or other compilations developed by the Commission from the data submitted in accordance with this chapter are public information. B. Disclosure under §A of this regulation may not be made in such a way that the data furnished for a specific patient can be identified. ### Chapter 07 — State Health Plan for Facilities and Services: Residential Treatment Centers **Authority:** Health-General Article, §§19-109(a)(1) and (3), 19-118, and 19-120, Annotated Code of Maryland **Administrative History:** Effective date: February 8, 1980 (7:3 Md. R. 264) **Administrative History:** Regulation .01 amended effective June 26, 1981 (8:13 Md. R. 1140) and October 12, 1981 (8:20 Md. R. 1635) **Administrative History:** Chapter recodified from COMAR 10.48.01 to 10.24.07 **Administrative History:** Regulation .01 amended effective September 10, 1984 (11:18 Md. R. 1584); February 9, 1987 (14:3 Md. R. 274); August 16, 1993 (20:16 Md. R. 1277) **Administrative History:** Regulation .01 amended as an emergency provision effective October 18, 1984 (11:23 Md. R. 1990); adopted permanently effective January 14, 1985 (12:1 Md. R. 16) **Administrative History:** Regulation .01 amended as an emergency provision effective January 16, 1985 (12:3 Md. R. 242); emergency status extended at 12:10 Md. R. 959; adopted permanently effective September 9, 1985 (12:18 Md. R. 1766) **Administrative History:** Regulation .01 amended as an emergency provision effective January 1, 1986 (13:2 Md. R. 135); emergency status extended at 13:10 Md. R. 1152; adopted permanently effective June 2, 1986 (13:11 Md. R. 1273) **Administrative History:** Regulation .01 amended as an emergency provision effective April 25, 1986 (13:10 Md. R. 1152); adopted permanently effective September 8, 1986 (13:18 Md. R. 2020) **Administrative History:** Regulation .01 amended as an emergency provision effective August 13, 1986 (13:18 Md. R. 2017); adopted permanently effective December 15, 1986 (13:25 Md. R. 2659) **Administrative History:** Regulations .01 amended and .02A repealed as an emergency provision effective April 2, 1992 (19:8 Md. R. 800); adopted permanently effective July 6, 1992 (19:13 Md. R. 1202) **Administrative History:** Regulation .02 adopted as an emergency provision effective May 21, 1986 (13:12 Md. R. 1372); emergency status expired September 28, 1986 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .02A amended as an emergency provision effective August 13, 1986 (13:18 Md. R. 2017); adopted permanently effective December 15, 1986 (13:25 Md. R. 2659) **Administrative History:** Regulation .02A amended effective May 28, 1990 (17:10 Md. R. 1219) **Administrative History:** Regulation .02A amended as an emergency provision effective February 1, 1991 (18:4 Md. R. 445) **Administrative History:** Regulation .02B adopted effective February 9, 1987 (14:3 Md. R. 274) **Administrative History:** Regulation .02B amended effective September 5, 1988 (15:18 Md. R. 2151); May 28, 1990 (17:10 Md. R. 1219); July 29, 1996 (23:15 Md. R. 1088) **Administrative History:** Regulation .02B amended as an emergency provision effective February 27, 1997 (24:6 Md. R. 481); amended permanently effective June 30, 1997 (24:13 Md. R. 932) **Administrative History:** Regulations .01 and .02 under Chapter, State Health Plan: Overview, Psychiatric Services, and Emergency Medical Services, repealed and new Regulation .01 under Chapter, State Health Plan for Facilities and Services: Residential Treatment Centers, adopted effective August 9, 2021 (48:16 Md. R. 631) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.07.01* The State Health Plan for Facilities and Services: Residential Treatment Centers is incorporated by reference. ### Chapter 08 — State Health Plan for Facilities and Services: Special Hospital — Chronic Services **Authority:** Health-General Article, §§19-109(a)(1), 19-118, and 19-120(f), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulation .01 adopted as an emergency provision effective February 1, 1991 (18:4 Md. R. 445); emergency status extended at 18:17 Md. R. 1911 and 19:3 Md. R. 302; emergency status superseded at 19:8 Md. R. 800, effective April 2, 1992 **Administrative History:** Regulation .01 adopted as an emergency provision effective April 2, 1992 (19:8 Md. R. 800); adopted permanently effective July 6, 1992 (19:13 Md. R. 1202) **Administrative History:** Regulation .01 amended effective May 8, 1995 (22:9 Md. R. 644); May 5, 1997 (24:9 Md. R. 657); December 1, 1997 (24:24 Md. R. 1670); August 9, 1999 (26:16 Md. R. 1246) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective April 15, 2002 (29:7 Md. R. 619) **Administrative History:** Regulation .01 amended effective March 12, 2007 (34:5 Md. R. 560); October 14, 2013 (40:20 Md. R. 1652); April 11, 2016 (43:7 Md. R. 450); July 15, 2019 (46:14 Md. R. 621) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.08.01* The State Health Plan for Facilities and Services: Special Hospital — Chronic Services is incorporated by reference. ### Chapter 09 — State Health Plan for Facilities and Services: Specialized Health Care Services — Acute Inpatient Rehabilitation Services **Authority:** Health-General Article, §§19-109(a)(1), 19-118, and 19-120, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 (Moratorium on Certificate of Need Application) adopted as an emergency provision effective August 1, 1985 (12:17 Md. R. 1696) (12:20 Md. R. 1921); emergency status extended at 12:26 Md. R. 2540; emergency status expired March 29, 1986 **Administrative History:** Regulation .01 (State Health Plan: Comprehensive Rehabilitation Services) adopted as an emergency provision effective June 10, 1987 (14:14 Md. R. 1565); emergency status expired November 10, 1987; adopted permanently effective January 25, 1988 (15:2 Md. R. 121) **Administrative History:** Chapter, State Health Plan: Comprehensive Rehabilitation Services, repealed and new Regulation .01 under chapter, State Health Plan: Acute Inpatient Rehabilitation Services, adopted effective March 11, 1996 (23:5 Md. R. 379) **Administrative History:** Regulation .01 amended effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective December 23, 2013 (40:25 Md. R. 2069) **Administrative History:** Regulation .01 amended as an emergency provision effective March 17, 2018 (45:8 Md. R. 418); amended permanently effective May 21, 2018 (45:10 Md. R. 503) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.09.01* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) The State Health Plan for Facilities and Services: Specialized Health Care Services — Acute Inpatient Rehabilitation Services. (2) Supplement No. 1. ### Chapter 10 — State Health Plan for Facilities and Services: Acute Care Hospital Services **Authority:** Health-General Article, §§19-109(a)(1) and (3), 19-118, 19-120, and 19-126, et seq, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.08, Hospital Capacity Plan, adopted as an emergency provision effective February 7, 1986 (13:5 Md. R. 526); emergency status extended at 13:22 Md. R. 2394; emergency status extended at 14:7 Md. R. 828 **Administrative History:** Regulation .01, State Health Plan: Acute Inpatient Services, adopted as an emergency provision effective July 16, 1987 (14:16 Md. R. 1770); emergency status extended at 14:18 Md. R. 1962 **Administrative History:** Regulation .01, State Health Plan: Acute Inpatient Services, adopted as an emergency provision effective September 23, 1987 (14:21 Md. R. 2220); adopted permanently effective February 8, 1988 (15:3 Md. R. 304) **Administrative History:** Regulation .01 amended as an emergency provision effective July 6, 1988 (15:16 Md. R. 1910); adopted permanently effective November 14, 1988 (15:23 Md. R. 2660) **Administrative History:** Regulation .01 amended effective December 20, 1993 (20:25 Md. R. 1947); July 1, 1996 (23:13 Md. R. 944); April 12, 2004 (31:7 Md. R. 584); April 24, 2006 (33:8 Md. R. 733) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2008 (35:25 Md. R. 2149) **Administrative History:** Regulation .01 amended effective January 26, 2009 (36:2 Md. R. 101) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective March 18, 2024 (51:5 Md. R. 229) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.10.01* The State Health Plan for Facilities and Services: Acute Care Hospital Services is incorporated by reference. ### Chapter 11 — State Health Plan for Facilities and Services: General Surgical Services **Authority:** Health-General Article, §§19-109(a)(1), 19-118, 19-120, and 19-120.1, Annotated Code of Maryland **Administrative History:** Effective date: August 16, 1993 (20:16 Md. R. 1277) **Administrative History:** Regulation .01 amended effective January 15, 1996 (23:1 Md. R. 25); November 12, 2012 (39:22 Md. R. 1429); January 15, 2018 (45:1 Md. R. 14) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective October 18, 2021 (48:21 Md. R. 889) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.11.01* The State Health Plan for Facilities and Services: General Surgical Services is incorporated by reference. ### Chapter 12 — State Health Plan for Facilities and Services: Acute Hospital Inpatient Obstetric Services **Authority:** Health-General Article, §19-118(a)(2), Annotated Code of Maryland **Administrative History:** Effective date: April 15, 2002 (29:7 Md. R. 620) **Administrative History:** Regulation .01 amended effective February 28, 2005 (32:4 Md. R. 410) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.12.01* The State Health Plan for Facilities and Services: Acute Hospital Inpatient Obstetric Services (Supplement No. 1) is incorporated by reference. ### Chapter 13 — State Health Plan for Facilities and Services: Hospice Services **Authority:** Health-General Article, §§19-109(a)(1) and 19-118, Annotated Code of Maryland **Administrative History:** Effective date: October 14, 2013 (40:20 Md. R. 1652) #### Regulation .01 Incorporation by Reference *COMAR 10.24.13.01* The State Health Plan for Facilities and Services: Hospice Services is incorporated by reference. ### Chapter 14 — State Health Plan for Facilities and Services: Alcoholism and Drug Abuse Intermediate Care Facility Treatment Services **Authority:** Health-General Article, §§19-109(a)(1) and 19-121, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulation .01 adopted as an emergency provision effective March 8, 1990 (17:7 Md. R. 843); emergency status extended at 17:22 Md. R. 2653 and 18:6 Md. R. 681; adopted permanently effective September 2, 1991 (18:17 Md. R. 1918) **Administrative History:** Regulation .01 amended as an emergency provision effective March 12, 1992 (19:7 Md. R. 742); amended permanently effective August 3, 1992 (19:15 Md. R. 1390) **Administrative History:** Regulation .01 amended effective January 21, 2002 (29:1 Md. R. 23); February 18, 2013 (40:3 Md. R. 218) **Administrative History:** Regulation .01C amended effective January 8, 2001 (27:26 Md. R. 2358) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.14.01* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) The State Health Plan for Facilities and Services: Alcoholism and Drug Abuse Intermediate Care Facility Treatment Services. (2) Supplement No. 1. ### Chapter 15 — State Health Plan for Facilities and Services: Specialized Health Care Services — Organ Transplant Services **Authority:** Health-General Article, §§19-101 et seq., Annotated Code of Maryland **Administrative History:** Effective date: September 5, 1988 (15:18 Md. R. 2152) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective January 14, 1999 (26:1 Md. R. 23) **Administrative History:** Regulation .01 amended effective February 7, 2000 (27:2 Md. R. 144) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective April 15, 2002 (29:7 Md. R. 620) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective February 27, 2017 (44:4 Md. R. 254) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.15.01* The State Health Plan for Facilities and Services: Specialized Health Care Services — Organ Transplant Services is incorporated by reference. ### Chapter 16 — State Health Plan for Facilities and Services: Home Health Agency Services **Authority:** Health-General Article, §§19-109(a)(1), 19-118, and 19-120(f), Annotated Code of Maryland **Administrative History:** Effective date: April 11, 2016 (43:7 Md. R. 450) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.16.01* The State Health Plan for Facilities and Services: Home Health Agency Services is incorporated by reference. ### Chapter 17 — State Health Plan for Facilities and Services: Specialized Health Care Services — Cardiac Surgery and Percutaneous Coronary Intervention Services **Authority:** Health-General Article, §§19-109(a) and (3), 19-118, 19-120, and 19-120.1, Annotated Code of Maryland **Administrative History:** Effective date: October 15, 1990 (17:20 Md. R. 2428) **Administrative History:** Regulation .01 amended effective January 15, 1996 (23:1 Md. R. 25) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective December 1, 1997 (24:24 Md. R. 1670) **Administrative History:** Regulation .01 amended effective May 14, 2001 (28:9 Md. R. 885); March 15, 2004 (31:5 Md. R. 449); August 10, 2009 (36:16 Md. R. 1251) **Administrative History:** Regulation .01 amended as an emergency provision effective January 14, 2012 (39:3 Md. R. 257); amended permanently effective March 19, 2012 (39:5 Md. R. 382) **Administrative History:** Regulation .01 amended effective August 18, 2014 (41:16 Md. R. 946); November 9, 2015 (42:22 Md. R. 1378) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective January 14, 2019 (46:1 Md. R. 12) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.17.01* The State Health Plan for Facilities and Services: Specialized Health Care Services — Cardiac Surgery and Percutaneous Coronary Intervention Services is incorporated by reference. ### Chapter 18 — State Health Plan for Facilities and Services: Specialized Health Care Services — Neonatal Intensive Care Services **Authority:** Health-General Article, §§19-109(a)(1) and 19-118, Annotated Code of Maryland **Administrative History:** Effective date: February 9, 1998 (25:3 Md. R. 145) **Administrative History:** Regulation .01B amended effective December 14, 1998 (25:25 Md. R. 1832); October 23, 2006 (33:21 Md. R. 1676) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.18.01* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) The State Health Plan: Specialized Health Care Services — Neonatal Intensive Care Services. (2) Supplement No. 1. (3) Supplement No. 2. ### Chapter 19 — State Health Plan for Facilities and Services: Freestanding Medical Facilities **Authority:** Health-General Article, §§19-109(a)(1), 19-114(d)(1)(viii), 19-118(a)(2)(i), 19-120(j)(2)(iv), and 19-120(o)(1) and (3), Annotated Code of Maryland **Administrative History:** Effective date: June 19, 2017 (44:12 Md. R. 587) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.19.01* The State Health Plan for Facilities and Services: Freestanding Medical Facilities is incorporated by reference. ### Chapter 20 — State Health Plan for Facilities and Services: Comprehensive Care Facility (Nursing Home) Services **Authority:** Health-General Article, §§19-103, 19-109(a)(1), 19-114, 19-118, 19-120, 19-120.2, 19-123, and 19-124, Annotated Code of Maryland **Administrative History:** Effective date: July 15, 2019 (46:14 Md. R. 622) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective February 17, 2025 (52:3 Md. R. 160) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.20.01* The State Health Plan for Facilities and Services: Comprehensive Care Facility (Nursing Home) Services is incorporated by reference. ### Chapter 21 — State Health Plan for Facilities and Services: Acute Psychiatric Services **Authority:** Health-General Article, §§19-109(a)(1) and (3), 19-118, and 19-120, Annotated Code of Maryland **Administrative History:** Effective date: August 9, 2021 (48:16 Md. R. 631) #### Regulation .01 Incorporation by Reference. *COMAR 10.24.21.01* The State Health Plan for Facilities and Services: Acute Psychiatric Services is incorporated by reference. ## Subtitle 25 — Maryland Health Care Commission ### Chapter 01 — Small Employer Health Benefit Plan Premium Subsidy Program **Authority:** Insurance Article, §§15-12A-01 — 15-12A-05, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .24 adopted as an emergency provision effective June 12, 2008 (35:14 Md. R. 1243); adopted permanently effective August 25, 2008 (35:17 Md. R. 1486) **Administrative History:** Regulation .02B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .06D adopted as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .10B amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .10C adopted as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); adopted permanently effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .17A amended as an emergency provision effective July 16, 2009 (36:17 Md. R. 1310); amended permanently effective October 19, 2009 (36:21 Md. R. 1591) #### Regulation .01 Scope. *COMAR 10.25.01.01* A. This chapter only applies to the Small Employer Health Benefit Plan Premium Subsidy Program as authorized by Insurance Article, §§15-12A-01 — 15-12A-05, Annotated Code of Maryland. B. Premium subsidies authorized under this chapter shall only be provided for health benefit plans that also comply with the provisions of COMAR 31.11.06. #### Regulation .02 Definitions. *COMAR 10.25.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Affiliated companies” means companies that are eligible to file a consolidated federal income tax return. (2) “Average wage of business” means the average of the annual wage of all eligible employees; for each eligible owner, the wage used to calculate the average for the business shall be the lesser of: (a) The eligible owner's countable wage; or (b) The eligible owner's adjusted gross income. (3) “Carrier” has the meaning stated in Insurance Article, §15-1201(c), Annotated Code of Maryland. (4) “COMAR” means the Code of Maryland Regulations. (5) “Commission” means the Maryland Health Care Commission. (6) “Commission registry” means a web-based utility by which employers and employees are enrolled in the Premium Subsidy Program. (7) “Commission's official website” means http://mhcc.maryland.gov/. (8) “Designated financial institution” means one or more financial institutions with whom the participating carrier has made arrangements for administration of HSAs in conjunction with the participating carrier's HSA compatible health benefit plan. (9) “Eligible employee” means an individual who: (a) Works on a full-time basis and has a normal workweek of at least 30 hours; and (b) Is either: (i) An employee; (ii) A partner of a partnership; (iii) An eligible owner; or (iv) An independent contractor who is included as an employee under a health benefit plan. (10) Eligible Owner. (a) “Eligible owner” means: (i) A person with a 20 percent or greater financial interest in a small employer who works at least 30 hours per week for that small employer; or (ii) An Executive Director of a nonprofit corporation that has been determined by the Internal Revenue Service to be exempt from taxation under §501(c)(3), (4), or (6) of the Internal Revenue Code who works at least 30 hours per week for that small employer. (b) “Eligible owner” includes an eligible owner's spouse who works at least 30 hours per week for the small employer. (11) “Eligible owner's adjusted gross income” means an amount equal to the adjusted gross income reported on the eligible owner's individual federal tax return or 50 percent of the adjusted gross income reported on the eligible owner's joint federal tax return for the most recent year. (12) “Eligible owner's countable wage” means an amount published by the Commission used to calculate the average wage of a small employer. (13) “Employee premium” means the amount of the premium that is paid by the employee for that employee's selected type of coverage. (14) “Employee premium subsidy” means, for a given employee's selected type of coverage, the amount of the premium subsidy that shall be passed through to the enrolled employee by the employer in the form of reduced payroll deductions for the health benefit plan. (15) “Employee's eligible HSA contribution” means the lesser of: (a) An amount published by the Commission; or (b) An employee's contribution to an HSA, made through regular payroll deductions deposited by the employer on behalf of the employee in the employee's HSA established at the carrier's designated financial institution. (16) Employee Wage. (a) “Employee wage” means, for a given eligible employee, the employee's estimated annual earnings at the time of initial or renewal application for the Premium Subsidy Program, including any salary, wages, commissions, bonuses, profit sharing, and reportable tips. (b) “Employee wage” includes, for purposes of this program, income received from an employee's ownership interest in the business. (17) “Employer's eligible HSA contribution” means an annual contribution to an employee's HSA: (a) Established at the carrier's designated financial institution; (b) Made by an employer according to a commitment made at enrollment or renewal; (c) Equal for all employees choosing a given HSA-compatible health benefit plan; and (d) Contributed either in a single payment at the beginning of the policy year or in equal installments throughout the policy year. (18) “Enrolled employee” means an eligible employee approved by the Commission to receive the premium subsidy. (19) “Enrolled employer” means a small employer approved by the Commission to receive the premium subsidy. (20) “Family” has the meaning stated in COMAR 31.11.06.02B(19). (21) Family Adjusted Gross Income. (a) “Family adjusted gross income” means, for an unmarried employee and for a married employee filing jointly, the adjusted gross income reported on the employee's most recent federal tax return. (b) “Family adjusted gross income”, for a married employee filing separately, means the sum of the adjusted gross income reported on the employee's most recent federal tax return and the adjusted gross income reported on the most recent federal tax return of the employee's spouse. (22) “Health benefit plan” has the meaning stated in Insurance Article, §15-1201(f), Annotated Code of Maryland. (23) “Health insurance” has the meaning stated in Insurance Article, §1-101(p), Annotated Code of Maryland. (24) “Health savings account (HSA)” means a health savings account as defined in the Medicare Prescription Drug, Improvement and Modernization Act of 2003, Title 12, §1201(a), as codified at Part VII, Subchapter B, Chapter 1, §223(d) of the Internal Revenue Code. (25) “Individual coverage” means a health benefit plan that insures an individual employee only. (26) “Initial application” means a subsidy applicant's first application to receive the premium subsidy. (27) “Licensed insurance producer” has the meaning stated in Insurance Article, §1-101(w), Annotated Code of Maryland. (28) “Maximum average wage for new applications” means an amount published by the Commission that represents the maximum average annual wage at which an employer not currently participating in the Premium Subsidy Program is eligible to apply for participation. (29) “Maximum average wage for participants” means an amount published by the Commission that represents the maximum average annual wage, calculated at time of renewal, at which an enrolled employer may continue to participate in the Premium Subsidy Program. (30) “Maximum eligible firm size” means a number published by the Commission that represents the largest number of eligible employees a small business may have at the time of policy renewal and still be eligible for participation in the Premium Subsidy Program. (31) “Maximum income for other than individual coverage” means an amount published by the Commission that represents the maximum family adjusted gross income at which an eligible employee may receive a premium subsidy for other than individual coverage. (32) “Maximum subsidy table” means a table published by the Commission that describes, for each type of coverage and average wage of business, the maximum premium subsidy that may be provided for each employee electing that type of coverage. (32-1) “Minimum countable wage” means an amount published by the Commission that represents the minimum annual wage for an eligible employee that can be used to calculate the average wage of a small employer. (33) “Other than individual coverage” means the following types of coverage: (a) Individual plus children; (b) Individual plus spouse; or (c) Individual plus children and spouse. (34) “Participating carrier” means a carrier who: (a) Participates in the Maryland small group market as defined under COMAR 31.11.06; (b) Agrees to offer a qualifying health plan; and (c) Enters into a written participation agreement with the Commission. (35) “Policy” has the meaning stated in Insurance Article, §1-101(ee), Annotated Code of Maryland. (36) “Policy year” means a 365-day period that begins on the policy's effective date or a period of 1 full calendar-year, under a health benefit plan providing coverage to employers and their employees, as defined in the policy. (37) “Premium” has the meaning stated in Insurance Article, §1-101(ff), Annotated Code of Maryland, applied to a given employee's selected type of coverage. (38) “Premium subsidy” means the amount paid to the participating carrier by the State in order to reduce the premium paid by the enrolled employer for a given eligible employee's selected type of coverage. (39) “Premium Subsidy Program” means the Small Employer Health Benefit Plan Premium Subsidy Program, as defined in Insurance Article, §15-12A-02, Annotated Code of Maryland. (40) “Prominent carrier” means a carrier that insures at least 10 percent of the total lives insured in the small group market. (41) “Qualifying health plan” means a Comprehensive Standard Health Benefit Plan, as defined under COMAR 31.11.06, together with riders, that includes a wellness benefit defined in Insurance Article, §15-1201(s), Annotated Code of Maryland. (42) “Quarterly wage reports” means the reporting of wages on quarterly employment reports as described in COMAR 09.32.01.14. (43) “Renewal application” means an application designated by the Commission for applying for renewal of the premium subsidy. (44) “Section 125 Payroll Deduction Plan” means a payroll deduction plan pursuant to §125 of the Internal Revenue Code. (45) “Size factor” means a factor published by the Commission, based on the number of eligible employees of a small employer at the time of policy renewal, and used to calculate the premium subsidy. (46) “Small employer” has the meaning stated in Insurance Article, §15-1201, Annotated Code of Maryland. (47) “Subsidy administrator” means one or more entities: (a) Designated by the participating carrier to administer enrollment, registration, billing, accounting, or reconciliation on behalf of the participating carrier; and (b) That is either a component of the carrier organization, or a separate entity under contract with the participating carrier that is bonded and subject to audit by the participating carrier and the Commission. (48) “Subsidy applicant” means either an employer or employee applying to receive the premium subsidy. (49) “Subsidy application” means an application designated by the Commission to be completed, signed, and submitted in order for the Commission to determine eligibility for the Premium Subsidy Program. (50) “Subsidy program cap” means a dollar amount published by the Commission that represents the Commission's estimate of the total annualized subsidy payment that is sustainable. (51) “Total premium” means the sum of all premiums for coverage under the employer's health benefit plan. (52) “Total premium subsidy” means the sum of all premium subsidies for coverage under the employer's health benefit plan. (53) “Type of coverage” means the choice of coverage for each eligible employee's health benefit plan, specifically: (a) Individual only; (b) Individual plus children; (c) Individual plus spouse; or (d) Individual plus children and spouse. (54) “Wellness benefit” has the meaning stated in Insurance Article, §15-201, Annotated Code of Maryland. (55) “Written participation agreement” means a contract between a participating carrier and the Commission that defines: (a) The terms and conditions of the participating carrier's involvement in the Premium Subsidy Program; and (b) The roles and responsibilities of the subsidy administrator in administering the Premium Subsidy Program. #### Regulation .03 Purpose. *COMAR 10.25.01.03* The Premium Subsidy Program is designed to: A. Provide an incentive for small employers to offer and maintain a small employer health benefit plan for their employees; B. Help low and moderate wage employees of small employers afford health benefit plan premiums; C. Promote access to health care services, particularly preventive health care services that might reduce the need for emergency room care and other acute care services; and D. Reduce uncompensated care in hospitals and other health care settings. #### Regulation .04 Employer Eligibility. *COMAR 10.25.01.04* A. A small employer is eligible to receive a premium subsidy if, at the time of initial application for the premium subsidy, the employer: (1) Meets the requirements under Insurance Article, §15-1203(b)(i), Annotated Code of Maryland; (2) Has been in operation for at least 12 months and, if required to file quarterly wage reports, has filed quarterly wage reports with the Maryland Department of Labor for, at a minimum, the three calendar quarters immediately preceding initial application for the premium subsidy; (3) Has not offered a health benefit plan to its employees for at least 12 consecutive months immediately before initial application for the premium subsidy; (4) Employed at least two but not more than nine eligible employees: (a) At the time the employer's subsidy application is entered into the Commission registry; and (b) On at least 50 percent of its working days during the preceding calendar quarter; (5) Has an average wage of business that does not exceed the maximum average wage for new applications; (6) Agrees to offer a health benefit plan to its eligible employees that contains a wellness benefit; (7) Commits to establish a Section 125 payroll deduction plan within 60 days of enrollment in the Premium Subsidy Program; (8) Completes and signs the subsidy application; and (9) Complies with the other regulations of this chapter. B. Affiliated companies are considered one employer for purposes of this chapter. C. An enrolled employer is eligible to continue receiving a premium subsidy if, at the time of the renewal application, the employer: (1) Has filed quarterly wage reports with the Maryland Department of Labor for, at a minimum, the three calendar quarters immediately preceding the renewal application for the premium subsidy; (2) Has at least two eligible employees and the number of eligible employees is not more than the maximum eligible firm size; (3) Has an average wage of business that does not exceed the maximum average wage for participants; (4) Continues to offer a health benefit plan to its eligible employees that contains a wellness benefit; (5) Has an established Section 125 payroll deduction plan in place for at least 10 months; (6) Completes and signs the subsidy application; and (7) Complies with the other regulations of this chapter. D. An enrolled employer whose coverage is terminated before the end of the policy year for any cause, including nonpayment of premium, is required to reapply and to meet all of the requirements for an initial application. E. If the carrier terminates the coverage but then reinstates the employer's coverage with the same premium and policy expiration date, the employer shall be reinstated in the Premium Subsidy Program without reapplication. F. Retroactive payments made by a small employer who is terminated and then reinstated by a carrier during a policy year are eligible for a premium subsidy. #### Regulation .05 Employee Eligibility. *COMAR 10.25.01.05* A. An eligible employee of a small employer is eligible to receive the premium subsidy if, at the time of initial application and at the time of each renewal application: (1) The small employer meets the requirements of Regulation .04 of this chapter; (2) The eligible employee enrolls in a health benefit plan offered by the small employer; (3) The eligible employee completes and signs the subsidy application; and (4) The eligible employee complies with the regulations of this chapter. B. An eligible employee applying for a premium subsidy for other than individual coverage shall satisfy the conditions described in Regulation .06 of this chapter. C. At the time of initial application for the premium subsidy and at the time of each renewal application, each employee subsidy applicant shall complete, sign, and submit to a licensed insurance producer a form designated by the Commission which includes the following information: (1) The type of coverage selected by the employee subsidy applicant; (2) Information requested by the Commission about any insurance coverage carried by the employee subsidy applicant or the applicant's family members during the 3 months immediately before the employee subsidy applicant's initial application for the premium subsidy; (3) Acknowledgement that the employee subsidy applicant's share of the premium will be deducted through a Section 125 payroll deduction plan; (4) If other than individual coverage is sought, an affidavit regarding the family's adjusted gross income and an agreement to provide documentation of the family's adjusted gross income to the Commission on request; and (5) Other information considered appropriate by the Commission. D. Unless allowed under Regulation .08 of this chapter, the following individuals are ineligible to receive a premium subsidy: (1) A former employee eligible for Continuation of Coverage under COMAR 31.11.04; (2) Divorced spouses eligible for Continuation of Coverage under COMAR 31.11.02; and (3) Surviving spouses eligible for Continuation of Coverage under COMAR 31.11.03. #### Regulation .06 Employee Selection of Other Than Individual Coverage. *COMAR 10.25.01.06* A. An eligible employee may apply for a premium subsidy for other than individual coverage if the eligible employee's family adjusted gross income does not exceed the maximum income for other than individual coverage. B. An eligible employee applying for a premium subsidy for other than individual coverage shall comply with requirements considered necessary by the Commission to verify the reported family adjusted gross income. C. An eligible employee with a family adjusted gross income greater than the maximum income for other than individual coverage is eligible for the premium subsidy for individual coverage if the eligible employee satisfies the conditions of Regulation .05 of this chapter. D. If a carrier offers coverage for domestic partners and the employer selects that coverage, a domestic partner is a spouse for the purposes of this chapter. #### Regulation .07 Initial Application and Enrollment. *COMAR 10.25.01.07* A. Initial application for the Premium Subsidy Program shall be made according to the procedures designated by the Commission and published on the Commission's official website. B. The small employer shall complete an initial application published on the Commission's official website that includes the following: (1) Information necessary to establish the eligibility of the small employer and the amount of the available subsidy; (2) An agreement by the small employer that the employer will establish a Section 125 payroll deduction plan within 60 days of enrollment; (3) An acknowledgement that: (a) The Commission may employ an auditor to examine an enrolled employer's records to determine the accuracy of statements made on the application; (b) Incorrect statements may be cause for exclusion from the Premium Subsidy Program; and (c) Fraudulent applications may be referred for prosecution; (4) An agreement to cooperate fully with the Commission and the Commission's auditor; and (5) An affidavit signed by the small employer that the information in the initial application is correct and that the small employer meets the eligibility criteria for receipt of a premium subsidy. C. The initial application shall include an affirmation signed by the licensed insurance producer that: (1) The health benefit plan or plans selected by the small employer include a wellness benefit; (2) The licensed insurance producer has examined the small employer's most recent Quarterly Wage Report, and the information in the initial application is consistent with that report; and (3) To the best of the licensed insurance producer's knowledge, the information in the initial application is correct. D. The initial application for each employee shall include the following: (1) Information about any private or public health insurance program that provided coverage at any time during the preceding 3 months for the employee or any of the employee's dependents who will be insured under the health benefit plan; and (2) For other than individual coverage: (a) An affidavit that the employee's family adjusted gross income is less than or equal to the maximum income for other than individual coverage; and (b) An agreement to provide copies of relevant tax return forms, if requested by the Commission. E. The participating carrier's procedures and written participation agreement determines whether the licensed insurance producer, the subsidy administrator, or the participating carrier shall enter the information from the initial application in the Commission registry to register the small employer to receive a premium subsidy. F. The Commission registry will generate: (1) A registration number; (2) The total premium subsidy that the participating carrier shall provide to the small employer in the form of a reduced total premium; (3) The amount of premium subsidy for each employee that the small employer shall pass through in the form of reduced payroll deductions for health benefits; and (4) Other information that the Commission may consider useful for administration of the Premium Subsidy Program. #### Regulation .08 Application and Enrollment of Additional Employees During the Policy Year. *COMAR 10.25.01.08* A. A newly hired eligible employee of an enrolled employer, an employee who becomes an eligible employee during the policy year, or an eligible employee who qualifies for a special enrollment period under 29 U.S.C. §1181(f) is eligible to be enrolled in the Premium Subsidy Program during the policy year under the terms established at the beginning of the policy year, unless either: (1) The participating carrier recalculates premiums charged to the enrolled employer; or (2) The Premium Subsidy Program is closed to registration of additional employees of enrolled employers under Regulation .19 of this chapter. B. The additional employee shall complete and sign the employee subsidy application required under Regulation .07 of this chapter. C. The participating carrier's procedures and the written participation agreement determines whether the licensed insurance producer, the subsidy administrator, or the participating carrier shall enter the information from the additional employee's subsidy application in the Commission registry to register the additional employee to receive the premium subsidy. D. If the participating carrier recalculates the premium rates charged to the enrolled employer, the employer shall complete the renewal application required under Regulation .09 of this chapter, including information about all current eligible employees. In this case, the total premium subsidy shall be recalculated for the small employer and eligible employees. #### Regulation .09 Renewal Application. *COMAR 10.25.01.09* A. The enrolled employer shall complete a renewal application published on the Commission's official website. The renewal application shall include: (1) Information necessary to establish the eligibility of the employer and the amount of the available premium subsidy; (2) An acknowledgement that the Commission may request that certain records be produced and made available; (3) An affidavit signed by the enrolled employer that the information in the renewal application is correct and that the enrolled employer meets the eligibility criteria for receipt of a premium subsidy; and (4) An affidavit signed by the enrolled employer that the enrolled employer has had a Section 125 payroll deduction plan in place over the 10-month period immediately preceding the planned date of premium subsidy renewal. B. The renewal application shall include an affirmation signed by the licensed insurance producer that: (1) The health benefit plan or plans selected by the enrolled employer include a wellness benefit; (2) The licensed insurance producer has examined the enrolled employer's most recent Quarterly Wage Report, and the information in the renewal application is consistent with that report; and (3) To the best of the licensed insurance producer's knowledge, the information in the renewal application is correct. C. The renewal application shall include a signed form from each employee applying for the Premium Subsidy Program who was either not insured under the employer's health benefit plan during the previous policy year or who is changing coverage from individual coverage to other than individual coverage. The form shall include: (1) Information about any private or public health insurance program that provided coverage at any time during the preceding 3 months for the employee or any of the employee's dependents who will be covered under the enrolled employer's health benefit plan; and (2) If the type of coverage is for other than individual coverage: (a) An affidavit that the employee's family adjusted gross income is less than the maximum income for other than individual coverage; and (b) An agreement to provide copies of relevant tax return forms, if requested by the Commission. D. The Commission's registry will generate: (1) A registration number; (2) The total premium subsidy that the participating carrier shall provide to the small employer in the form of reduced total premium; (3) Total premium subsidy for each enrolled employee that the small employer shall pass through in the form of reduced payroll deductions for health benefits; and (4) Other information that the Commission may consider useful for administration of the Premium Subsidy Program. E. The participating carrier's procedures and written participation agreement determines whether the licensed insurance producer, the subsidy administrator, or the participating carrier shall enter the information from the renewal application in the Commission registry to register the enrolled employer to receive a premium subsidy. #### Regulation .10 Calculation of the Average Wage of Business. *COMAR 10.25.01.10* A. The average wage of business is the average of the wage for each of the eligible employees of the business. B. For employees who are eligible owners, the wage used in calculating the average wage of business shall be the greater of the following: (1) The lesser of: (a) The eligible owner's countable wage; or (b) The eligible owner's adjusted gross income; or (2) The minimum countable wage. C. For all other eligible employees, the wage used in calculating the average wage of business is the greater of: (1) The employee wage; or (2) The minimum countable wage. #### Regulation .11 Calculation of the Premium Subsidy. *COMAR 10.25.01.11* A. At the time of initial application for the Premium Subsidy Program, the premium subsidy is the lower of: (1) The amount from the maximum subsidy table applicable for the average wage of business and the type of coverage chosen by the employee; or (2) 50 percent of the sum of: (a) The premium for the type of coverage chosen by the eligible employee; (b) The employer's eligible HSA contribution, if any; and (c) The employee's eligible HSA contribution, if any. B. At the time of renewal application for the Premium Subsidy Program, the premium subsidy is the lower of: (1) The amount from the maximum subsidy table applicable for the average wage of business and the type of coverage chosen by the employee, multiplied by the size factor for the number of eligible employers; or (2) 50 percent of the sum of: (a) The premium for the type of coverage chosen by the eligible employee; (b) The employer's eligible HSA contribution, if any; and (c) The employee's eligible HSA contribution, if any. C. For each health benefit plan offered by an enrolled employer, the premium subsidy remains constant throughout the policy year unless the premium changes during the policy year. #### Regulation .12 Change in Employer's Federal Employer Identification Number. *COMAR 10.25.01.12* If the federal employer identification number of the employer changes, because the company changes its form of ownership or for any other reason, the company may petition the Commission for continued eligibility for the Premium Subsidy Program under the new federal employer identification number. The Executive Director shall rule on the petition within 14 days of the receipt of all information necessary to make the determination of continued eligibility. #### Regulation .13 Change of Participating Carrier by the Enrolled Employer. *COMAR 10.25.01.13* A. If the enrolled employer elects to change coverage from one participating carrier to a different participating carrier at the time of policy renewal and premium subsidy renewal, the enrolled employer shall identify the new carrier in the renewal application. B. If the enrolled employer elects to change coverage from one participating carrier to a different participating carrier at any time other than the time of policy renewal and premium subsidy renewal, the enrolled employer shall notify the Commission at least 30 days in advance of the change and shall complete the renewal application specified under Regulation .09 of the chapter for the new health benefit plan. #### Regulation .14 Payment of the Premium Subsidy. *COMAR 10.25.01.14* A. Payment of the total premium subsidy is subject to the following: (1) The total premium subsidy for each enrolled employer shall be paid to the subsidy administrator and shall reduce the total premium owed by the enrolled employer; (2) The enrolled employer shall pass the employee premium subsidy to the enrolled employee in the form of reduced payroll deductions for the health benefit plan; (3) The employee premium subsidy is calculated as the premium subsidy for that employee's coverage multiplied by the ratio of the sum of the employee premium plus the employee's eligible HSA contribution, if any, to the sum of the premium, the employer's eligible HSA contribution, if any, and the employee's eligible HSA contribution, if any; (4) Each month, the subsidy administrator or participating carrier shall invoice the enrolled employer for the total premium due for the subsequent month, minus the subsidy amount for enrolled employees registered in the Commission registry; (5) At the time the enrolled employer is invoiced for the premium by the subsidy administrator or participating carrier, the subsidy administrator or participating carrier shall submit an invoice to the Commission, in a format set forth in the written participation agreement between the Commission and the participating carrier, that lists, for each enrolled employer, the invoiced premium and the premium subsidy due for each enrolled employee; (6) The Commission shall promptly forward the invoice to the Comptroller for payment of the premium subsidy to the subsidy administrator or participating carrier; (7) The subsidy payment is accounted for separately from other funds and is not considered to be earned by the participating carrier until the participating carrier has received the corresponding premium payment from the enrolled employer; and (8) Each month, the subsidy administrator or participating carrier shall provide to the Commission, in a format set forth in the written participation agreement between the Commission and the participating carrier, the following: (a) A list of all premium payments received from enrolled employers during the previous month, including the coverage period for which each premium payment was made; and (b) A list of the enrolled employees covered by each premium payment. B. Each premium subsidy paid in advance to a participating carrier that does not correspond to an enrolled employer's premium payment shall be deducted from a subsequent premium subsidy paid to the participating carrier, and a reconciliation statement shall be provided by the Commission to the participating carrier. #### Regulation .15 Carrier Requirements. *COMAR 10.25.01.15* A. To participate in the Premium Subsidy Program, a carrier shall meet the definition of a participating carrier under Regulation .02B(34) of this chapter. B. The written participation agreement shall include: (1) The carrier's designation of its subsidy administrator or administrators; (2) The Commission's requirement for monthly data submissions regarding premium subsidy recipients covered by the participating carrier; and (3) The participating carrier's agreement to cooperate with any audits of the Premium Subsidy Program. C. A participating carrier may not condition the sale of a wellness benefit to a small employer based on participation of the eligible employees of that small employer in wellness programs or activities. D. A prominent carrier shall offer at least one health benefit plan to a small employer who meets the requirements described in Regulation .04 of this chapter and shall enter into a written participation agreement with the Commission. #### Regulation .16 Licensed Insurance Producer Requirements. *COMAR 10.25.01.16* A licensed insurance producer in connection with the sale, solicitation, or negotiation of a health benefit plan to a small employer who meets the requirements described in Regulation .04 of this chapter shall: A. Provide information to the small employer about wellness benefits; B. At the time of initial application or at the time of policy renewal, advise the small employer to consult a tax advisor about the tax advantages of a Section 125 payroll deduction plan; C. For small employers providing an HSA compatible health benefit plan to their employees, advise the small employers of the designated financial institution required to be utilized for administration of the employee's HSA account, if the HSA contributions are to be included in the calculation of the total premium subsidy; and D. Ensure completion of the required employer and employee applications including any required affidavits, and forward the original copies of the applications to the carrier's subsidy administrator. #### Regulation .17 Premium Subsidy Program Design Factors. *COMAR 10.25.01.17* A. At least once each year, the Commission shall publish on the Commission's official website for informal public comment a list of the proposed Premium Subsidy Program design factors, including: (1) Eligible owner's countable wage; (2) Employee's eligible HSA contribution; (3) Maximum average wage for new applications; (4) Maximum average wage for participants; (5) Maximum eligible firm size; (6) Maximum income for other than individual coverage; (7) Maximum subsidy table; (8) Minimum countable wage; (9) Size factor; and (10) Subsidy program cap. B. Proposed components of the Premium Subsidy Program may be based on a number of factors including, but not limited to: (1) Current and projected enrollment in the Premium Subsidy Program; (2) Current and projected demographics of enrolled employers and enrolled employees in the Premium Subsidy Program; (3) Enrollment rate by small employers and eligible employees; (4) Inflation; (5) Changes in premiums; (6) Appropriations for the Premium Subsidy Program by the Maryland General Assembly; (7) Any surplus amounts in the Premium Subsidy Program; and (8) Any projected shortages in the Premium Subsidy Program. C. Following the informal public comment period, the Commission shall consider the public comments received, adopt revisions that the Commission considers appropriate, and publish the revisions on the Commission's official website and in the Maryland Register. #### Regulation .18 Closing the Premium Subsidy Program to the Entry of New Businesses. *COMAR 10.25.01.18* A. The Executive Director may close the program to the entry of new businesses by closing the Commission registry to new registration, notifying the participating carriers, and posting notice on the Commission's official website. B. This action shall be taken when the subsidies for the coming year are projected to reach or exceed the subsidy program cap, and may be taken at other times for reasons that the Executive Director considers sufficient. C. Advance notice of this action is desirable, but not required. D. This action shall be reviewed by the Commission at its next meeting. #### Regulation .19 Closing the Premium Subsidy Program to the Entry of Additional Employees of Enrolled Employers. *COMAR 10.25.01.19* A. The Executive Director may close the Premium Subsidy Program to the entry of new employees by closing the Commission registry to registration of additional employees, notifying the participating carriers and enrolled employers, and posting notice on the Commission's official website. B. This action shall be reviewed by the Commission at its next meeting. #### Regulation .20 Reopening the Premium Subsidy Program. *COMAR 10.25.01.20* A. Following closure of the Premium Subsidy Program under Regulation .18 or .19 of this chapter, the Commission may reopen the Premium Subsidy Program through a formal action specifying both the application process and the criteria that will be used to select new participants from among those applying. Selection criteria may include the average wage of the business, the geographic distribution of enrolled employers, or any other factor formally designated by the Commission. B. The Commission shall notify the participating carriers and shall post notice on the Commission's official website of the reopening of the Premium Subsidy Program. If the Premium Subsidy Program was closed under Regulation .19 of this chapter, the Commission shall also notify enrolled employers. #### Regulation .21 Penalties. *COMAR 10.25.01.21* A. In any conduct relating to the Premium Subsidy Program, employers, employees, participating carriers, subsidy administrators, and licensed insurance producers are subject to criminal and civil penalties under applicable law for any knowing and willful making of a materially false or fraudulent statement and the knowing and willful use of a false or fraudulent document. B. Employers, employees, participating carriers, subsidy administrators, and licensed insurance producers deemed by the Commission to be in violation of this chapter may be temporarily or permanently excluded from participation in the Premium Subsidy Program by the Commission. C. If temporarily excluded from the Premium Subsidy Program by the Commission, an enrolled employer and its enrolled employees are not eligible for the Premium Subsidy Program for 12 months and must requalify for the Premium Subsidy Program at the time of reapplication. #### Regulation .22 Decisions of the Commission — Delegation of Program Administration to the Executive Director. *COMAR 10.25.01.22* A. Decisions of the Commission relating to policies, regulations, and program design under Regulations .17 — .20 of this chapter may not be delegated. B. All other decisions of the Commission regarding program administration, including determinations of eligibility under Regulations .04, .05, .06, .12, and 13 of this chapter, subsidy calculations under Regulation .11 of this chapter, and penalties under Regulation .21 of this chapter are delegated to the Executive Director. #### Regulation .23 Appeals of Decisions of the Executive Director. *COMAR 10.25.01.23* A. Decisions of the Executive Director may be appealed to the Commission. B. The appeal shall be in writing and filed with the Commission within 30 days of the date of the decision of the Executive Director. C. The appeal shall state specifically the facts of the situation and the justification for the Commission to change the decision of the Executive Director. The appeal may: (1) Present significant, relevant information that was not previously presented to the Commission and that, with reasonable diligence, could not have been presented before the Executive Director made a decision; (2) Demonstrate that there have been significant changes in factors or circumstances relied upon by the Executive Director in reaching the decision; or (3) Demonstrate that the Executive Director has materially failed to follow the Commission's adopted procedures in reaching the decision. D. Within 15 days of the filing of the appeal, the Executive Director shall submit a written response to the appeal and send it to the appellant. The appellant shall have 10 days to submit a written response for consideration by the Commission. E. The Commission may act on the appeal in one of the following ways: (1) By a majority vote of the full Commission; (2) By a majority vote of an appeals committee, whose members shall be appointed by the Chair of the Commission; or (3) By a decision of an appeals commissioner, appointed by the Chair of the Commission. F. The Chair of the Commission shall determine which of the methods under §E of this regulation the Commission will use to act on the appeal. G. The Commission may act on the appeal based on the written appeal record alone, or may hold a hearing before acting on the appeal. H. The Commission may affirm, reverse, or modify the decision of the Executive Director and shall make written findings of fact and conclusions of law stating the basis for its decision within 30 days of its decision on the appeal. #### Regulation .24 Appeals of Decisions of a Participating Carrier. *COMAR 10.25.01.24* Actions taken by a participating carrier, including actions taken by a participating carrier that affect a small employer's eligibility for participation in the Premium Subsidy Program or the amount of the premium subsidy, shall be handled through the customary appeals processes for carrier decisions and may not be appealed to the Commission. ### Chapter 02 — User Fee Assessment on Health Care Practitioners **Authority:** Health-General Article, §19-111, Annotated Code of Maryland **Administrative History:** Effective date: June 6, 1994 (21:11 Md. R. 951) **Administrative History:** Regulation .01B amended effective August 21, 2000 (27:16 Md. R. 1524); April 11, 2005 (32:7 Md. R. 681) **Administrative History:** Regulation .02 amended effective March 18, 2002 (29:5 Md. R. 503); April 11, 2005 (32:7 Md. R. 681) **Administrative History:** Regulation .02C amended effective August 21, 2000 (27:16 Md. R. 1524); April 20, 2009 (36:8 Md. R. 596); July 22, 2013 (40:14 Md. R. 1175); May 22, 2017 (44:10 Md. R. 473) **Administrative History:** Regulation .03 adopted effective March 18, 2002 (29:5 Md. R. 503) #### Regulation .01 Definitions. *COMAR 10.25.02.01* A. In this chapter, the following terms have the meanings indicated: B. Terms Defined. (1) “Affected licensing board” means a licensing board of which all licensees are required by the Commissioner to pay a user fee. (2) “Commission” means the Maryland Health Care Commission. (3) “Health care practitioner” has the meaning stated in Health-General Article, §19-111, Annotated Code of Maryland. (4) “Licensing board” means a unit within the Maryland Department of Health that regulates health care practitioners by the issuance and renewal of licenses to practice a health care profession. (5) “User fee” means the amount set forth in the fee schedule that each assessed health care practitioner pays as part of a license renewal fee. #### Regulation .02 Method of User Fee Assessment. *COMAR 10.25.02.02* A. The Commission annually shall identify the health care practitioners to be assessed a user fee. B. Based on the Commission budget, the Commission shall establish a fee schedule which sets forth the fee that each health care practitioner shall pay as part of the renewal fee required to be paid to an affected licensing board. C. The formula the Commission shall use to calculate the fee set forth in the fee schedule is 16 percent of the total assessed fees per fiscal year divided by the number of health care practitioners identified pursuant to §A of this regulation. D. The Commission shall provide the affected licensing boards with the fee schedule within sufficient time for the user fee to be included in the license renewal billing cycle. #### Regulation .03 Waiver of the Fee Assessment Requirements. *COMAR 10.25.02.03* A. The Commission shall identify the average annual wage for health care practitioners by using comparable classifications in the State Classification and Salary Compensation Plan. B. The Commission shall determine the average annual wage by utilizing a salary range based on compensation from lowest to highest for each health care practitioner. C. The Commission shall waive the assessment for a health care practitioner whose average annual wage is substantially below that of other health care practitioners. ### Chapter 03 — User Fee Assessment on Payers, Hospitals, and Nursing Homes **Authority:** Health-General Article, §19-111, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .04 adopted as an emergency provision effective July 1, 1994 (21:15 Md. R. 1301); adopted permanently effective December 5, 1994 (21:24 Md. R. 1988) **Administrative History:** Regulations .01 — .03 amended as an emergency provision effective June 8, 1995 (22:13 Md. R. 965); emergency status extended at 22:20 Md. R. 1540; emergency status expired January 15, 1996; adopted permanently effective February 12, 1996 (23:3 Md. R. 168) **Administrative History:** Regulations .01 — .04 repealed and new Regulations .01 — .03 adopted effective August 21, 2000 (27:16 Md. R. 1525) **Administrative History:** Regulation .02C amended effective March 18, 2002 (29:5 Md. R. 503); April 11, 2005 (32:7 Md. R. 681); April 20, 2009 (36:8 Md. R. 596); July 22, 2013 (40:14 Md. R. 1175); May 22, 2017 (44:10 Md. R. 473); July 22, 2024 (51:14 Md. R. 678) #### Regulation .01 Definitions. *COMAR 10.25.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Assessment” means the total dollar amount that the Commission bills payers, hospitals, and nursing homes for a given fiscal year. (2) “Commission” means the Maryland Health Care Commission. (3) “Health benefit plan” has the meaning stated in Insurance Article, §15-201, Annotated Code of Maryland. (4) “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. (5) “Nursing home” means a related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland, that is classified as a nursing home. (6) “Payer” means a: (a) Health insurer; (b) Nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in the State; or (c) Health maintenance organization that holds a certificate of authority in this State. (7) “User fee” means that portion of the assessment that each payer remits to the Administration pursuant to the formula established in Health-General Article, §19-111, Annotated Code of Maryland. #### Regulation .02 Method of User Fee Assessment. *COMAR 10.25.03.02* A. On or before June 30 of each year, the Commission shall assess each payer, hospital, and nursing home a fee in accordance with §B of this regulation. B. Assessment of Fees. (1) For each fiscal year, the Commission shall assess a fee on payers, hospitals, and nursing homes. (2) Fees shall be assessed on each payer by apportioning the total amount of fees to be assessed payers based on the ratio of each payer's total premiums collected in the State for health benefit plans to the total collected premiums of all payers collected in the State. The apportionment shall be based on premium information reported by the Insurance Commissioner. (3) A fee shall be assessed on each hospital that is equal to the sum of: (a) The amount equal to one-half of the total fees to be assessed on hospitals under §C of this regulation times the ratio of admissions of the hospital to total admissions of all hospitals; and (b) The amount equal to one-half of the total fees to be assessed on hospitals under §C of this regulation times the ratio of gross operating revenue of each hospital to total gross operating revenues of all hospitals. (4) A fee shall be assessed on each nursing home that is equal to the sum of: (a) The amount equal to one-half of the total fees to be assessed on nursing homes under §C of this regulation times the ratio of admissions of the nursing home to total admissions of all nursing homes; and (b) The amount equal to one-half of the total fees to be assessed on nursing homes under §C of this regulation times the ratio of gross operating revenue of each nursing home to total gross operating revenues of all nursing homes. C. For July 1, 2023 — June 30, 2026, the amount assessed on payers may not exceed 26 percent of the total amount assessed by the Commission. The amount assessed on hospitals may not exceed 39 percent of the total amount assessed. The amount assessed on nursing homes may not exceed 19 percent of the total amount assessed. #### Regulation .03 Payment of User Fees. *COMAR 10.25.03.03* A. On or before September 1, each payer assessed a user fee in accordance with the provisions of Health-General Article, §19-111, Annotated Code of Maryland, and this chapter shall make payment in the manner directed by the Commission. B. The Commission may make provisions upon the request of a payer for installment payments of the user fee, as the Commission considers necessary and appropriate. C. Any bill not paid within 30 days of the payment due date may be subject to an interest penalty to be determined and collected by the Commission. D. In addition to any penalties the Commission may impose on a payer, hospital, or nursing home that fails to pay the user fee in a timely manner, the Commission may refer the payer's delinquent account to the Department of Budget and Management's Central Collection Unit pursuant to the procedures in State Finance and Procurement Article, §3-301 et seq., Annotated Code of Maryland, and COMAR 17.01.01. ### Chapter 04 — Hospital Quality and Performance Evaluation System **Authority:** Health-General Article, §§19-109(a)(1) and (7) and 19-134(e), Annotated Code of Maryland **Administrative History:** Effective date: October 15, 2001 (28:20 Md. R. 1783) **Administrative History:** Regulation .04 amended effective December 23, 2002 (29:25 Md. R. 1982) **Administrative History:** Chapter revised effective June 16, 2008 (35:12 Md. R. 1120) #### Regulation .01 Definitions. *COMAR 10.25.04.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Commission” means the Maryland Health Care Commission. (2) “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. #### Regulation .02 Hospital Evaluation — Data Collection and Reporting Requirements. *COMAR 10.25.04.02* A. Each hospital shall file with the Commission data on measures to be included in the Commission's comparative quality and performance evaluation system and the Health Services Cost Review Commission's quality-based reimbursement initiative. The measures may be drawn from, but are not limited to, the: (1) National Quality Forum; (2) Hospital Quality Alliance; (3) Quality Indicator Project of the Maryland Hospital Association; (4) Agency for Healthcare Research and Quality; (5) Hospital Quality Initiative of the Centers for Medicare and Medicaid Services; (6) Centers for Disease Control and Prevention's National Healthcare Safety Network; (7) Joint Commission's ORYXR initiative; or (8) Work of academic, professional, healthcare research, and patient safety organizations. B. The measures shall relate to the outcomes of healthcare services and the process through which those services are delivered for the hospital as a whole as well as specific clinical areas and may include, but are not limited to, the following: (1) Acute myocardial infarction; (2) Cardiac surgery and angioplasty; (3) Emergency department care; (4) Healthcare-associated infections; (5) Heart failure; (6) Maternity and newborn care; (7) Patient experience; (8) Patient safety; (9) Pediatric care; (10) Pneumonia; (11) Health information technology; and (12) Intensivist staffing. C. The Commission shall provide notice in the Maryland Register and on its website of the form, format, and schedule for submission of data on measures to be reported to the Commission under this regulation. #### Regulation .03 Summary Studies, Reports, and Compilations. *COMAR 10.25.04.03* A. Subject to §B of this regulation, summary studies, reports, or other compilations of data developed by the Commission from the data submitted in accordance with this chapter are public information. B. Disclosure under §A of this regulation may not be made in such a way that the data furnished for a specific patient can be identified. C. The Commission shall publish annually, on a comparative basis, the results of the quality and performance evaluation system through one or more reports. The reports may also compare hospital performance to public health goals established by the Secretary of Health or the United States Public Health Service, United States Department of Health and Human Services. #### Regulation .04 Extension of Time. *COMAR 10.25.04.04* A. A hospital may request an extension of time of up to 30 days for submission of data required in Regulation .02 of this chapter. B. The hospital shall: (1) Submit the request to the Executive Director of the Commission not later than 30 days before the data are due; (2) Explain the reason for the extension request; and (3) Propose a reasonable specific date for submission of the report. C. A hospital may file a written petition with the Commission for review of a denial of an extension of time request. D. The Commission shall review the decision of the Executive Director. The Commission may affirm, reverse, or modify the decision of the Executive Director after providing the hospital with an opportunity to present its position to the Commission. #### Regulation .05 Penalty for Failure to File Reports. *COMAR 10.25.04.05* A hospital that does not timely file data may be subject to penalties described in COMAR 10.25.12. ### Chapter 05 — Data Release **Authority:** Health-General Article, §§19-103(c)(3), 19-109(a)(1) and (7) and (b)(5), and 19-133(d), and 19-134, Annotated Code of Maryland **Administrative History:** Effective date: June 19, 1995 (22:12 Md. R. 900) **Administrative History:** Regulation .01 amended effective October 15, 2001 (28:20 Md. R. 1783) **Administrative History:** Regulation .02 amended effective October 15, 2001 (28:20 Md. R. 1783); October 22, 2007 (34:21 Md. R. 1915) **Administrative History:** Regulation .04 amended effective December 23, 2002 (29:25 Md. R. 1983) **Administrative History:** Regulation .06 amended effective March 10, 1997 (24:5 Md. R. 412) **Administrative History:** Regulation .06 repealed and new Regulation .06 adopted effective October 15, 2001 (28:20 Md. R. 1783) **Administrative History:** Regulation .06 repealed effective October 22, 2007 (34:21 Md. R. 1915) **Administrative History:** Regulations .01—.05 under Small Group Market Data Collection repealed and new Regulations .01—.14 under Data Release adopted effective December 13, 2021 (48:25 Md. R. 1079) #### Regulation .01 Scope and Purpose. *COMAR 10.25.05.01* A. This chapter addresses the requirements, parameters, administrative process, and procedures for submission, review, approval, and disapproval of requests for data from the Maryland Medical Care Data Base, any other information collected and stored in the Maryland Medical Care Data Base, and any data submitted to the Maryland Health Care Commission from a claims clearinghouse certified by the Commission that qualify as directly or indirectly individually identifiable health information, as defined in the Health Insurance Portability and Accountability Act of 1996, including all pertinent implementing regulations at 45 CFR Parts 160 and 164. B. The Commission releases data pursuant to this chapter to facilitate uses of data that are in the public interest, such as to develop public policy, promote improvement in health care access, delivery, efficiency, quality, safety, and public health outcomes, contain costs, and advance the transparency of the health care system. C. The Commission retains all ownership rights to any data released pursuant to this chapter. A recipient of data released pursuant to this chapter does not obtain any right, title, or interest in data released to a data recipient pursuant to this chapter. D. This chapter does not apply to: (1) Requests for information from the Maryland Medical Care Data Base or any other Commission data base considered public under the Maryland Public Information Act and any other applicable laws and regulations; (2) Internal activities that are required of the Commission to conduct its lawful business of assembling the Maryland Medical Care Data Base, or any other data base that it is authorized to create and maintain; (3) Data released to any person, governmental entity, or other entity with which the Commission has contracted pursuant to State procurement policy and laws; (4) Data released, pursuant to the terms and conditions of a written, signed data use agreement entered into between the Commission and a State governmental entity, as defined in Regulation .02B of this chapter, that has an express statutory or regulatory mandate under Maryland law to access and use requested data; (5) Data that the Commission is expressly authorized and required to release under applicable federal or State law requirements, provided the release of the data complies with and is limited to the relevant requirements of the applicable law. (6) Data released pursuant to compulsory process, such as a subpoena, discovery request, warrant, or court order, issued under lawful authority in the course of litigation or an administrative proceeding before a State or federal court or administrative tribunal of competent jurisdiction, provided that prior to release of the data the Commission has made a reasonable effort to secure, or has secured, an appropriate protective order from the court or administrative tribunal, or a stipulation of the parties that: (a) Prohibits the use or disclosure of the data by the parties for any purpose other than the litigation or proceeding for which the data was sought; and (b) Requires the return of the data to the Commission or destruction of the data, including all copies of the data, at the end of the litigation or proceeding. #### Regulation .02 Definitions. *COMAR 10.25.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “All-payor claims database” or “APCD” means a large-scale database that systematically collects and aggregates enrollment, claims, and provider information from private and public payors in a state. (2) “Applicant” means a person, governmental entity, or other entity that submits an application requesting data from the Commission. (3) “Application” means a written request for data submitted in the form and manner specified by the Commission. (4) “Commission” means the Maryland Health Care Commission. (5) “Data extract” means a subset of information from the Maryland medical care database or other data base maintained by the Commission based on criteria provided by an applicant. (6) “Data recipient” means a person, governmental entity, or other entity whose application has been approved and who is authorized to access and use data requested in an application in accordance with a data use agreement. (7) “Data release” means the process of providing a data recipient with access and use of data requested in an application in accordance with a data use agreement. (8) “Data Release Advisory Committee” or “DRAC” means a multi-stakeholder group of individuals appointed by the Commission whose functions include but are not limited to that of privacy board review as described in 45 CFR §164.512, reviewing completed applications, and making a written recommendation to the Executive Director regarding whether an application should be approved, approved with conditions, or disapproved. (9) “Data set” means a collection of separate data elements or variables that can be manipulated as a unit. (10) “Data use agreement” means a written contractual document entered into between the Commission and a data recipient that contains terms and conditions that govern a data recipient’s access to and use of data provided by the Commission. (11) “De-identified data” means information that does not identify an individual and for which there is no reasonable basis to believe that it can be used to identify an individual. (12) “Direct individual identifier” means personal information such as name, Social Security number, and date of birth that uniquely identifies an individual or that can be combined with other readily available information to uniquely identify an individual. (13) “Disclose” means the release, redisclosure, transfer, provision, access, transmission, communication, or divulgence in any other manner of data release pursuant to this chapter. (14) Entity. (a) “Entity” means a person, partnership, firm, association, limited liability company, limited liability partnership, or public or private corporation. (b) “Entity includes a county or municipality of Maryland or a governmental entity of another state. (15) “Executive Director” means the Executive Director of the Maryland Health Care Commission. (16) “Funding source” means any federal or state governmental entity, public or private corporation or organization, educational or research institution or organization, foundation, person, individual, or other entity that has committed to give or grant, or has already given or granted, monetary funds to an applicant to cover all or part of the costs of the proposed use of the data described in an application submitted to the Commission. (17) Governmental Entity. (a) “Governmental entity” means any agency, authority, board, commission, council, department, instrumentality, unit, or other body of State government or the federal government that is established by law. (b) “Governmental entity” does not include a county or municipality of Maryland or a governmental entity of another state. (18) “HIPAA” means the United States Health Insurance Portability and Accountability Act of 1996, P.L.10491, as implemented and amended in federal regulations, including the HIPAA Privacy and Security Rules, 45 CFR Parts 160 and 164, as they may be amended, modified, or renumbered, including as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act. (19) “Identifiable data” means information that contains data elements that can be used to identify a specific individual. (20) “Indirect individual identifier” means a data element that can be used to identify an individual when combined with other information or data. (21) “Institutional Review Board” or “IRB” has the meaning stated in 45 CFR Part 46, and any subsequent revisions of those regulations, as they may be amended, modified, or renumbered, regarding the protection of human subject research. (22) “Medicaid” means the Maryland Medical Assistance Program. (23) “Medical Care Data Base” or “MCDB” means the data base established and maintained by the Commission pursuant to Health-General Article, §19-133, Annotated Code of Maryland, that collects eligibility data, professional services claims, institutional services claims, pharmacy claims, and provider data for Maryland residents enrolled in private insurance, Medicaid, or Medicare. The MCDB is Maryland’s all-payer claims data base. (24) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, representative of any kind, partnership, firm, association, corporation, or other entity. (25) “Product” means any creation derived in whole or part from data released pursuant to this chapter, including an analysis, article, chart, compilation, display, finding, graph, information, manuscript, map, presentation, publication, report, service, software, study, subscription service, summary, table, or website. (26) “Protected health information” or “PHI” means individually identifiable health information as defined in the HIPAA Privacy Rule at 45 CFR §160.103, as it may be amended, modified, or renumbered. (27) “State” means: (a) When capitalized, the State of Maryland; or (b) When lowercase, any state, possession, territory, or commonwealth of the United States, or the District of Columbia. #### Regulation .03 Types of Data Available for Release. *COMAR 10.25.05.03* A. The types of data specified in §C of this regulation may be released to an applicant whose application has been approved in accordance with the requirements of this chapter. B. The availability of the types of data specified in §C of this regulation requesting Medicaid data are subject to a determination of availability by Medicaid. C. Data may be provided pursuant to an approved application at the following levels of detail: (1) De-identified standard analytic file: A data extract that contains only data elements that are not considered PHI because the extract excludes direct and indirect individual identifiers as defined in the HIPAA Privacy Rule. (2) Limited data set: A data extract that contains a limited set of indirect individual identifiers as defined in the HIPAA Privacy Rule and excludes direct individual identifiers. (3) Custom data file: A data extract that is created based on criteria provided by an applicant and deemed the minimum amount necessary for an applicant’s proposed use of the data and consists of: (a) Indirect individual identifiers that can be used to identify individuals when combined with other information or data; or (b) Aggregate, summary data in which the risk of identifying individuals is minimal. #### Regulation .04 Requests for Medicaid Data. *COMAR 10.25.05.04* A. An application submitted to the Commission that includes a request for Medicaid data shall be referred to Medicaid for review after Commission staff has reviewed the application and determined the application to be complete in accordance with Regulation .06 of this chapter. B. Medicaid shall review an application referred pursuant to §A of this regulation and notify Commission staff in writing within 15 business days of the date of referral of Medicaid’s decision to: (1) Proceed with its own independent application review and decision-making process on that part of an application requesting Medicaid data: (a) Without further involvement or participation of Commission staff, the DRAC, or the full Commission; and (b) That is not governed by the review and decision-making process in Regulations .07—.14 of this chapter; (2) Decline to proceed with its own independent application review and decision-making process as described in §B(1) of this regulation and direct Commission staff to proceed with processing the referred application in accordance with Regulations .07—.11 of this chapter; or (3) Disapprove the request for Medicaid data based on the information provided in an application, in which case Medicaid shall provide reasons for the disapproval in the written notification to Commission staff. C. If Commission staff does not receive written notification from Medicaid within 15 business days of referring an application to Medicaid pursuant to §§A and B of this regulation, Commission staff shall proceed with processing the application in accordance with Regulations .07—.11 of this chapter. #### Regulation .05 Requests for Data from Governmental Entities. *COMAR 10.25.05.05* A. A governmental entity requesting data shall submit a written data request in the form and manner specified by the Commission that shall: (1) Be signed by the agency head or chief executive officer of a governmental entity; and (2) Include a signed statement by a governmental entity’s legal counsel that the governmental entity has legal authority to use the requested data for the purpose described in the written data request. B. The written data request submitted in accordance with §A of this regulation shall include at a minimum: (1) A description of the proposed purpose and use of the data requested and, if applicable, a description of an intention to incorporate the data requested into a product; (2) A description of, and reasons for, any proposed linkages to other data; (3) A data management plan that demonstrates appropriate privacy and security controls for access and storage of the data and for protection against inadvertent and unauthorized access and disclosure of the data; and (4) The safeguards against re-identification of an individual in a product that will be created or published publicly by the governmental entity. C. The Executive Director may make a final decision on whether to approve, approve with conditions, or disapprove a governmental entity’s data request provided that, prior to making a final decision, the Executive Director considers each of the criteria for approval and each reason for disapproval described in §E of this regulation. D. The Executive Director may exercise the discretion not to make a final decision on a governmental entity’s request for data and refer the data request to the DRAC for review and a written recommendation in accordance with Regulation .09 of this chapter. Upon receipt of a written report and recommendation from the DRAC, the Executive Director may, in the Executive Director’s discretion, either: (1) Make a final decision in accordance with Regulation .10A—C of this chapter; or (2) Refer the DRAC’s report and recommendation to a panel of three Commission members or the full Commission in accordance with Regulation .10D—E of this chapter for a decision on the data request. E. In reviewing and making a recommendation or final decision on whether a data request shall be approved, approved with conditions, or disapproved, the Executive Director, the DRAC, a panel of three Commission members, or the full Commission, as applicable, shall determine whether the proposed use of the data requested: (1) Falls within the public interest uses described in Regulation .01B of this chapter; (2) Meets the applicable criteria for approval in Regulation .09C of this chapter; or (3) Should be disapproved for any of the reasons in Regulation .09D of this chapter. F. Prior to the receipt of data pursuant to an approved data request, a governmental entity shall enter into a written data use agreement with the Commission in accordance with Regulation .13 of this chapter. #### Regulation .06 Requests for Data from Nongovernmental Entities. *COMAR 10.25.05.06* A. Submission of Applications. (1) An applicant shall complete and submit a written application in the form and manner specified by the Commission. (2) An applicant shall disclose on an application all potential or approved funding sources at the time of submission of an application. (3) If applicable, an applicant shall disclose any data sharing or other requirements imposed by a funding source as a condition of receipt of funding. (4) An applicant shall disclose on an application whether an applicant or any person or entity that is an officer, owner, operator, or part of management of an applicant’s organization who will have access and use of the requested data is currently, or has been within 10 years prior to the date of the application, a subject of or a party to a state or federal regulatory agency action or civil or criminal action involving a data breach, HIPAA violation, or other matter involving unauthorized access, use, and disclosure of data regardless of whether there has been a finding or admission of guilt, including being: (a) Convicted of a felony or pleading guilty, nolo contendere, entering a best interest plea of guilty, or receiving a diversionary disposition regarding a felony; (b) A subject of an investigation conducted by, or a pending complaint, charge, or indictment issued by, a local, state, or federal governmental regulatory agency or other state or federal law enforcement agency; or (c) A party to a final dispositive action in a state or federal governmental agency regulatory action or a civil action that resulted in entry into a settlement agreement, consent agreement, decree or order, corporate integrity agreement, corrective action agreement, or other similar agreement or other disposition in a civil action regardless of whether there has been an admission or finding of guilt or liability. (5) A person who signs an application shall: (a) Be an officer of an applicant’s organization who has been given signatory authority to bind the organization, unless an applicant is not part of an organization and is requesting data in an applicant’s individual capacity, in which case the applicant shall sign an application; and (b) Sign the following affirmation statement: “I solemnly affirm under the penalties of perjury that the contents of the application and any supplementary information are true to the best of my knowledge, information, and belief.” (6) An applicant shall pay a nonrefundable application fee in the amount specified in the list of fees published on the Commission’s website at the time of submission of an application. B. Completeness Review. (1) An application is not complete until an applicant has submitted a completed application, as determined by Commission staff, and provided any additional information, documentation, answers to questions, and clarifications requested by Commission staff within the time limit specified by Commission staff. (2) After Commission staff has determined that an application is complete, Commission staff shall refer an application requesting Medicaid data to Medicaid for review in accordance with Regulation .04 of this chapter. (3) If Commission staff has received a written response from Medicaid specifying its decision on whether to proceed on the request for Medicaid data under either Regulation .04B(1), (2) or (3) of this chapter, Commission staff shall refer a completed application, Medicaid’s written response, all supporting documentation, and any public comment received under Regulation .07 of this chapter, to the DRAC for further review in accordance with Regulation .09 of this chapter. (4) In accordance with Regulation .04C of this chapter, if Commission staff has not received a written response from Medicaid within 15 business days of Commission staff’s referral of the application to Medicaid, then Commission staff shall proceed with processing the application, including the request for Medicaid data, in accordance with Regulations .07—.11 of this chapter. (5) If Medicaid disapproves the part of an application requesting Medicaid data pursuant to Regulation .04B(3) of this chapter, an applicant shall notify Commission staff in writing within 15 business days of an applicant’s wishes regarding further consideration of a non-Medicaid part of an application, specifically, whether an applicant requests that: (a) Commission staff refer the part of a completed application requesting non-Medicaid data to the DRAC for further review in accordance with Regulation .09 of this chapter; or (b) An applicant’s entire application be withdrawn and receive no further consideration, in which case Commission staff shall administratively close the application pursuant to §B(7) of this regulation. (6) If an applicant fails to notify Commission staff in writing within 15 business days of receiving notice that Medicaid has disapproved the Medicaid part of an application as required under §B(5) of this regulation, Commission staff may administratively close an application pursuant to §B(7) of this regulation. (7) An application may be administratively closed and receive no further consideration if: (a) An applicant fails to provide a complete application, in the judgment of Commission staff, including providing all additional information, documentation, answers to questions, and clarifications requested by Commission staff, or by the DRAC during its review of an application under Regulation .09 of this chapter, within the time limit specified by Commission staff or the DRAC; or (b) An applicant fails to provide the written notification within 15 business days as required under §B(5) of this regulation. (8) For an applicant to receive further consideration of a request for data in an application that was administratively closed under §B(7) of this regulation, an applicant shall file a new application and pay the required fees that are in effect at the time of submission of a new application. #### Regulation .07 Transparency of Data Request and Data Release Process. *COMAR 10.25.05.07* A. Except for applications submitted by governmental entities pursuant to an express state or federal statutory or regulatory mandate, all completed applications shall be published on the Commission’s website during the pendency of the review process, without those parts of the application that specify an applicant’s proposed data management plan and security measures. B. Members of the public may submit written comment on an application for a period of 10 business days following the date on which an application is published on the Commission’s website. C. Commission staff shall provide all public comments received on an application to the DRAC for review and consideration in accordance with Regulation .09 of this chapter. D. After a decision has been made on an application, the following information shall be published on the Commission’s website: (1) The disposition of an application; that is, whether the application has been: (a) Approved; (b) Approved with conditions; (c) Disapproved; or (d) Withdrawn; (2) For approved applications: (a) The amount of fees charged for requested data; (b) A statement that all fees were waived; or (c) In the case of a partial waiver of fees, the amount of fees waived; (3) If applicable, notice that further review of a decision on the application is pending under Regulation .11 of this chapter and a description of the final decision when the further review process is completed; and (4) A summary description of a product derived in whole or part from data released to an applicant pursuant to this chapter, subject to any prohibition on public disclosure under applicable federal or State law, including the Maryland Public Information Act. #### Regulation .08 Data Release Advisory Committee. *COMAR 10.25.05.08* A. The Commission shall establish a Data Release Advisory Committee (DRAC) that meets the membership composition requirements and performs the review functions of a privacy board as described in 45 CFR §164.512. B. The Commission shall appoint the members of the DRAC and a chairperson from among the appointed members. C. The number of members appointed to the DRAC shall be at the discretion of the Commission but large enough to: (1) Represent the appropriate range of stakeholder groups described in §D of this regulation; and (2) Provide relevant experience, professional competency, and subject matter expertise in the areas of consumer privacy and advocacy, data analytics, data privacy, data security, health policy research, individual privacy issues, information technology, public health, and the use and analysis of health care claims data. D. The membership of the DRAC shall include, but not be limited to: (1) Representatives of various stakeholder groups, including academic research organizations, consumer advocacy organizations, employers, health care providers, health maintenance organizations, insurers, and nonprofit health service plans, that possess the relevant experience, professional competency, and subject matter expertise described in §C(2) of this regulation; (2) At least one representative from Medicaid; (3) At least one Commission staff member who shall serve as an ex-officio member; and (4) Any additional representatives that the Commission determines are needed. E. Members of the DRAC shall serve for a term not to exceed 3 years. At the end of a term, a member continues to serve until a successor is appointed. A member of the DRAC may be reappointed. F. The DRAC shall meet as necessary to: (1) Review completed applications requesting data; (2) Prepare reports and recommendations, with the administrative support of Commission staff, and submit them to the Executive Director; (3) If requested by Commission staff or the Executive Director, provide advice, consultation, and expertise on issues and questions that may arise: (a) During Commission staff’s review of applications under Regulations .05 and .06 of this chapter; (b) During the Executive Director’s review of applications under Regulation .10 of this chapter; and (c) After an application has been approved and requested data has been released to a data recipient, regarding compliance and enforcement of a data use agreement under Regulations .13 and .14 of this chapter; and (4) Perform any other duties and obligations required of the DRAC under this chapter. G. Commission staff shall provide the necessary administrative support required for the DRAC to perform its duties and obligations under this chapter, such as facilitating the scheduling and conducting of DRAC meetings, providing DRAC meeting agendas and supporting reference materials, conducting research and obtaining additional information as requested by the DRAC, and assisting in the preparation of written reports and recommendations. H. The Executive Director may remove a member of the DRAC for neglect of duty or misconduct by providing written notification to the DRAC member, stating the reason for the removal. I. A member of the DRAC who receives written notification of removal under §H of this regulation may submit a written request for full Commission review of the Executive Director’s removal decision within 20 business days of the date of the Executive Director’s written notification of removal. The written request for full Commission review shall state with particularity the grounds and factual basis for the DRAC member’s disagreement with the Executive Director’s decision to remove the DRAC member. #### Regulation .09 Data Release Advisory Committee Review. *COMAR 10.25.05.09* A. The following data requests are not subject to review by the DRAC: (1) Those categories of data requests and data release described in Regulation .01D(1)—(5) of this chapter; (2) Requests for data submitted by a governmental entity that the Executive Director determines warrants an expedited review under Regulation .05 of this chapter; and (3) Requests for aggregate, summarized data as described in Regulation .03C(3)(b) of this chapter. B. In reviewing an application, the DRAC shall consider the criteria for approval and reasons for disapproval of an application in §§C and D of this regulation and all public comment received under Regulation .07 of this chapter before preparing a written report and recommendation. C. The DRAC shall determine whether an application has met the following criteria for approval: (1) An applicant has provided documentation of relevant education, training, and experience that demonstrates the applicant is capable of undertaking and accomplishing the objective of the proposed use of the data and being a responsible steward of the requested data. (2) The data elements requested by an applicant are the minimum amount necessary to achieve the intended purpose for which the data is requested. (3) The proposed use of the data complies with applicable State and federal laws, including those laws relating to the privacy and security of protected health information (PHI). (4) The applicant has provided a written data management plan that demonstrates appropriate privacy and security controls for access and storage of the data and for safeguarding individual privacy and preventing unauthorized access and use of the data. (5) The requirement of obtaining written authorization from each individual who is the subject of requested identifiable data can be waived in accordance with 45 CFR §164.512. (6) If the applicant has proposed linkage of the requested data to other data source(s), the applicant has provided: (a) Sufficient written justification of the need to link the requested data to the other data source(s) named in the application to accomplish the objective and achieve the results of the proposed use of the data; and (b) Written proof that an additional level of data privacy and security controls will be in place to protect the privacy and identification of the individuals who are the subject of the requested data and the other data source(s) to which the requested data is to be linked. (7) An applicant who proposes to develop and sell a product that contains de-identified data has provided satisfactory written justification of how the proposed sale of the product using the de-identified data will serve the public interest. (8) The proposed use of the data is in the public interest. Examples of uses of data that serve the public interest include: (a) Health care cost and utilization analysis to guide and develop public policy; (b) Studies that promote improvement in public health, health care quality, and health care access; (c) Health planning and resource allocation studies; (d) Making information on cost and quality accessible to the public; and (e) Studies directly tied to evaluation and improvement of federal and State government initiatives. D. The DRAC shall determine whether an application has met any of the following criteria for disapproval: (1) The proposed use of the data violates State or federal law. (2) The proposed use of the data is not in the public interest. (3) The proposed use of the data is designed so that the stated objective of the project cannot be met. (4) False information or documentation on, or related to, an application was provided to Commission staff, the DRAC, the Executive Director, or the Commission. (5) An applicant provided incomplete information upon which to base a decision on the application. (6) An applicant or any person or entity that is an officer, owner, operator, or part of management of an applicant’s organization who will have access and use of the requested data is currently, or has been within 10 years prior to the date of the application, a subject of or a party to a state or federal regulatory agency action or civil or criminal action involving a data breach, HIPAA violation, or other matter involving unauthorized access, use, and disclosure of data regardless of whether there has been a finding or admission of guilt, including being: (a) Convicted of a felony or pleading guilty, nolo contendere, entering a best interest plea of guilty, or receiving a diversionary disposition regarding a felony; (b) A subject of an investigation conducted by, or a pending complaint, charges, or indictment issued by a local, state, or federal governmental regulatory agency or other state or federal law enforcement agency; or (c) A party to a final dispositive action in a state or federal governmental agency regulatory action or a civil action that resulted in entry into a settlement agreement, consent agreement, decree or order, corporate integrity agreement, corrective action agreement, or other similar agreement or other disposition in a civil action regardless of whether there has been an admission or finding of guilt or liability. (7) Violation of a previous data use agreement. (8) The data management plan does not demonstrate privacy and security controls for safeguarding individual privacy and preventing unauthorized access to or use of the data. (9) The proposed use of the data is for an impermissible purpose, which includes but is not limited to: (a) Using the requested data to identify an individual using a particular product or drug in order to develop a marketing campaign and directly contact an individual; (b) Using the requested data to contact an individual for fund-raising purposes directly; and (c) Using the requested data to contact an individual who is the subject of the data for any reason. (10) An applicant who proposes to develop and sell a product that contains requested de-identified data has not provided satisfactory written justification of how the proposed sale of the product using the de-identified data will serve the public interest. E. A member of the DRAC who has an affiliation with an applicant, or with any entity sponsoring, participating, or otherwise affiliated with an applicant’s proposed use of the requested data or any other conflict of interest or appearance of impropriety, shall recuse from consideration of that applicant’s application and may not participate in any discussions with other DRAC members or vote on the application. F. The DRAC may request that the Executive Director authorize the DRAC to invite an individual with expertise and competence in certain areas to assist the DRAC in the review of complex issues that require expertise beyond, or in addition to, that available among the membership of the DRAC. An individual invited pursuant to this section may not: (1) Have an affiliation with an applicant, or with any entity sponsoring, participating in, or otherwise affiliated with an applicant’s proposed use of the requested data or any other conflict of interest or appearance of impropriety; and (2) Vote on an application. G. The DRAC may require an applicant to obtain Institutional Review Board review prior to deciding on a recommendation for an application. H. The DRAC may request that Commission staff obtain additional information and documentation from an applicant if needed to determine whether the criteria for approval in §C of this regulation have been met or the reasons for disapproval in §D of this regulation exist. If an applicant does not provide the additional information within the time limit specified by the DRAC, the DRAC may refer the application to Commission staff with a request that the application submitted by the applicant be administratively closed per Regulation .06B(7) of this chapter. I. The DRAC, at its discretion, may require that an applicant meet with the DRAC to provide additional information, answer questions, or provide clarification on information provided in an application, the proposed use of the data requested, or the capability of an applicant to accomplish the objective of the proposed use of requested data. J. The DRAC shall review and consider all public comment received regarding an application under Regulation .07 of this chapter before making a recommendation to the Executive Director. K. The DRAC, with the administrative support of Commission staff, shall prepare a written report and recommendation for the Executive Director on each application reviewed, which shall address: (1) Each of the approval criteria in §C of this regulation; (2) Each of the disapproval criteria in §D of this regulation; (3) Any public comment received; and (4) The DRAC’s recommendation on whether an application should be approved, approved with conditions, or disapproved. L. After an application is approved pursuant to Regulation .10 of this chapter, Commission staff may: (1) Seek the advice and expertise of the DRAC on any issues regarding the applicant’s receipt of data or compliance with the terms and conditions of a data use agreement entered into under Regulation .13 of this chapter; and (2) Request that the DRAC prepare a written report and recommendation to the Executive Director regarding whether any compliance and enforcement actions may be warranted under Regulation .14 of this chapter. M. A DRAC recommendation on an application or on other issues related to an applicant’s receipt of data or compliance with the terms and conditions of a data use agreement entered into under Regulation .13 of this chapter is advisory and not binding on the Executive Director’s decision on an application or on whether to pursue an enforcement action under Regulation .14 of this chapter for noncompliance with a data use agreement. #### Regulation .10 Executive Director Review and Decision on Requests for Data. *COMAR 10.25.05.10* A. Before making a decision on an application requesting data, the Executive Director shall: (1) Review and consider the DRAC’s written report and recommendation; (2) Review all public comment received; (3) Determine whether the approval criteria set forth in Regulation .09C of this chapter have been met; and (4) Determine whether any of the disapproval criteria set forth in Regulation .09C of this chapter exists for disapproval of an application under Regulation .09D of this chapter. B. If the Executive Director determines that there is insufficient information upon which to base a decision on an application, the Executive Director may refer an application back to the DRAC with a request that the DRAC, through Commission staff, obtain and provide more specific or additional information, conduct a more detailed review and evaluation of the review criteria, and, if appropriate, submit a revised written report and recommendation. C. After considering the DRAC’s written report and recommendation on an application, the Executive Director shall issue a written decision: (1) Approving an application; (2) Approving an application subject to conditions, which shall be included as conditions in the data use agreement required under Regulation .13 of this chapter; or (3) Disapproving an application. D. If the Executive Director decides not to adopt the DRAC’s recommendation, specifically to approve an application that the DRAC has recommended be disapproved, or to disapprove an application that the DRAC has recommended be approved, then the Executive Director shall prepare a proposed recommended decision and refer to the full Commission for consideration and issuance of a final decision affirming, reversing, or modifying the Executive Director’s recommended decision. E. The Executive Director may exercise the discretion not to make a decision on an application and refer the DRAC’s written report and recommendation, and all public comment received on an application, to a review panel of 3 Commission members, which shall include a consumer member of the Commission. A review panel may render a final written decision on the application, or elect not to make a decision and refer the application to the full Commission for a decision. F. The Executive Director may not make a decision on an application that proposes to develop and sell a product that contains requested de-identified data and shall refer the application, the DRAC’s written report and recommendation, and all public comment received on the application to the full Commission for a decision. G. The Executive Director, a review panel, or the full Commission, as applicable, shall issue a written decision notifying an applicant that an application has been approved, approved with conditions, or disapproved. The written decision shall state the conditions imposed, if any, and, if an application is disapproved, state the reasons for disapproval. #### Regulation .11 Review of Decisions on Requests for Data. *COMAR 10.25.05.11* A. Request for Further Review of Decisions on Requests for Data. (1) An applicant may submit a written request for full Commission review of a written decision issued by the Executive Director or a review panel, as applicable, under Regulation .10G of this chapter, within 20 business days of the date the written decision is issued, which shall: (a) State with particularity the grounds and factual basis for an applicant’s disagreement with the decision and include citations to specific documentation or authority for each argument made in support of an applicant’s disagreement with the decision; (b) Include all relevant supporting documentation and authority cited in §A(1)(a) of this regulation; (c) Specify the remedy requested: (i) Reversal of the decision and unconditional release of the requested data; or (ii) Modification of the decision to release the requested data subject to conditions; and (d) If desired, include a written request to present oral argument to the full Commission, which shall be scheduled if requested. (2) After reviewing and considering an applicant’s written request for review of a decision and any oral argument, if applicable, the full Commission shall issue a written decision affirming, reversing, or modifying the decision reviewed. B. Request for Reconsideration of Commission Decisions on Requests for Data. (1) If the full Commission, instead of the Executive Director or a review panel, issues a decision on an application, an applicant may submit, within 20 business days of the date the Commission’s written decision was issued, a written request, which shall conform to §A(1) of this regulation, that the Commission reconsider its decision. (2) The Commission shall review and consider an applicant’s written request for reconsideration of its previous decision and any oral argument, if requested, and issue a written decision affirming, reversing, or modifying its previous decision. #### Regulation .12 Fees. *COMAR 10.25.05.12* A. The Commission may charge fees to an applicant and data recipient for: (1) Submission of an application; and (2) The cost of accessing data, which may include but is not limited to the costs of producing and releasing data to a data recipient. B. A list of fees to be charged pursuant to §A of this regulation shall be published on the Commission’s website, reviewed annually, and updated as needed. C. A list of proposed fees shall be published on the Commission’s website for receipt of written public comment for a period of 30 days before the proposed fees become final. All public comment received shall be considered before the proposed fees become final. D. An applicant shall pay the required application fee in full before Commission staff may begin the application review process. An application fee paid by an applicant is nonrefundable. E. An applicant who is approved to receive requested data shall pay all required fees in full prior to receipt of requested data. Fees paid by an approved data recipient for receipt of requested data are nonrefundable. F. If an approved applicant does not pay the required fees in full within 30 days of the date of written notification of application approval, the applicant will not receive the requested data and the application shall be deemed withdrawn and will receive no further consideration. G. The Executive Director may grant a partial or full waiver of fees for requested data if: (1) An applicant submits a written request for partial or full waiver of fees detailing reasons for the waiver request and, if applicable, state the amount of partial waiver requested; (2) An applicant provides financial statements or any other supporting documentation requested by the Executive Director regarding the applicant’s inability to pay required fees; (3) An applicant is a recipient of monetary funds from a funding source that covers all or part of the costs of an applicant’s use of the data, and the applicant provides documentation of: (a) An applicant’s written proposal requesting funding submitted to a funding source; (b) A funding source’s response to an applicant’s request for funding and, if applicable, funding approval; (c) Any requirements, including data sharing, imposed by a funding source as a condition of receipt of funding; (d) The budget governing an applicant’s use and allocation of the monetary funds that a funding source has granted or given to an applicant; and (e) Any other documentation regarding a funding source requested by the Executive Director; (4) An applicant timely provides any other information and documentation requested by the Executive Director; and (5) After considering all information provided by an applicant in support of a full or partial fee waiver, the Executive Director determines that a full or partial waiver of fees is in the public interest. H. Before making a final decision on a request for a partial or full waiver of fees under §G of this regulation, the Executive Director may consult with a review panel or the full Commission if the Executive Director deems it appropriate. #### Regulation .13 Data Use Agreement. *COMAR 10.25.05.13* A. An approved applicant shall enter into and sign a data use agreement prior to receipt of the requested data. If an approved applicant does not sign a data use agreement within 30 days of the date of written notification of application approval, the application shall be deemed withdrawn and will receive no further consideration. B. Prior to entry into a data use agreement and receipt of requested data, an approved applicant shall disclose any data sharing plan or agreement required by a funding source as a condition of an applicant’s receipt of funding. C. A data use agreement entered into with a data recipient under §A of this regulation shall, at a minimum: (1) Define the scope of use of the requested data and the research methodology; (2) Provide a plan for safeguarding the privacy and security of the data and complying with all applicable laws governing the privacy and security of data; (3) Require a data recipient to adhere to security processes and procedures aimed at preventing unauthorized access, use, or disclosure of the data; (4) Require that a data recipient notify Commission staff of any potential or actual data breach, including any instance of unauthorized access, use, or disclosure of data, no later than 7 days from the date of knowledge of the breach; (5) Require a data recipient to notify Commission staff in writing within 24 hours of receipt of any request from a third party requesting a data recipient to disclose all or part of the data received from the Commission, including but not limited to compulsory process, such as a subpoena, discovery request, warrant, or judicial or administrative order, or a public information act request, to provide the Commission adequate time to intervene and respond before the date that a data recipient has been requested or ordered to provide the data; (6) Specify the beginning and end dates of a data use agreement; (7) Provide for the return or destruction of data by a certain date upon termination of a data use agreement, or upon a determination that a data recipient has failed to comply with a data use agreement; (8) Require that a data recipient comply and assist, if requested, in any audit of compliance with a data use agreement; (9) Provide that a breach of any term or condition of a data use agreement is a breach of contract; (10) Permit that appropriate administrative and judicial remedies under applicable law may be pursued against a data recipient for failing to comply with the terms and conditions of a data use agreement; and (11) Be signed by: (a) A person authorized to contractually bind a data recipient’s organization; or (b) A data recipient, if a data recipient is not part of an organization. D. The Executive Director may consider a request from a data recipient for an extension of time or a modification of a term or condition of an executed data use agreement if: (1) A data use agreement includes an express provision allowing a request for an extension of time or a modification of a term or condition; (2) A data recipient submits a written request in the form and manner specified by the Commission, which shall include the reasons for the request, or specify good cause for the extension or modification request; (3) A request for an extension of time states the requested new end date for the data use agreement; and (4) A request for modification does not seek approval of a new or different use of the released data that was not approved under Regulation .10 of this chapter. E. Commission staff shall refer a written request for an extension of time or a modification of a term or condition of a data use agreement to the Executive Director for a decision. The Executive Director shall: (1) Consider a data recipient’s written request submitted under §D of this regulation before making a decision; and (2) Make a decision to approve, approve with conditions, or disapprove the request, and notify the data recipient in writing of the decision. F. If the Executive Director approves an extension or modification request, or approves with conditions, the Executive Director shall issue a signed, dated written amendment to the data use agreement approving the extension or modification request, stating the new end date of the data use agreement, if applicable, and specifying any additional conditions on the extension or modification. G. Re-Use of Data. (1) A data recipient who wishes to re-use data previously released, pursuant to an approved application and executed data use agreement prior to the termination of the data use agreement and destruction of the data, for a different use or purpose or to link with other data sources not described in the approved application shall submit a written application in the form and manner specified by the Commission and pay a nonrefundable application fee in the amount published on the Commission’s website at the time of submission of an application for re-use of previously released data. (2) Commission staff shall refer a data recipient’s completed application for re-use of previously released data prior to termination of a data use agreement for a different use for DRAC and Executive Director review, in accordance with Regulations .09—.11 of this chapter. (3) If a re-use application is approved, a data recipient shall pay the applicable nonrefundable data re-use fees in full in the amount published on the Commission’s website before a data recipient can use the previously released data for a different use or purpose. H. A data recipient who wishes to request additional data not requested in a data recipient’s approved application and described in a data use agreement shall: (1) Submit a new application in the form and manner specified by the Commission and pay a new nonrefundable application fee in accordance with Regulation .12 of this chapter, regardless of whether a data recipient intends to use the additional data for the same use described in a data recipient’s previously approved application; and (2) Pay required fees for receipt of additional data in accordance with Regulation .12 of this chapter if a data recipient’s request for additional data is approved. #### Regulation .14 Compliance and Enforcement. *COMAR 10.25.05.14* A. If a data recipient fails to comply with any of the terms and conditions of a data use agreement, or it becomes known after execution of a data use agreement that a data recipient provided false information during the application process, the Commission, acting through the Executive Director, may take one or more of the following administrative and judicial enforcement actions, depending upon the facts, circumstances, and gravity of the acts of noncompliance: (1) Terminate a data recipient’s current access to data; (2) Suspend a data recipient’s current access to data for a period of time: (a) Subject to conditions that a data recipient must satisfy before the suspension may be lifted and access to data reinstated; or (b) If required by the Executive Director, until a data recipient enters into a new data use agreement that requires compliance with a corrective action plan addressing the acts of noncompliance; (3) Require a data recipient to suspend or retract for a designated period of time a product that has been created or published from the data, subject to conditions that a data recipient must satisfy before the suspension or retraction may be lifted; (4) Demand the secure destruction or return of data and require documentary proof that all data released to a data recipient has been destroyed; (5) Terminate a data use agreement; or (6) Prohibit a data recipient from submitting a new application requesting data for a designated period of time. B. The Executive Director may refer an instance of unauthorized access, use, or disclosure of data to the Office of the Attorney General of Maryland, the Maryland State’s Attorney Office, or any other appropriate State or federal law enforcement authority. C. The Commission, based upon information provided by the Executive Director, may seek any appropriate administrative and judicial remedy allowed by State or federal law for: (1) Failing to comply with any terms and conditions for accessing and using data; and (2) Any instance of unauthorized or impermissible access, use, and disclosure of data. ### Chapter 06 — Maryland Medical Care Data Base and Data Collection **Authority:** Health-General Article, §§19-101, 19-103(c)(3), (4), (7), and (8), 19-109(a)(1), (6), and (7), 19-133, 19-134, and 19-137, Annotated Code of Maryland **Administrative History:** Effective date: January 15, 1996 (23:1 Md. R. 26) **Administrative History:** Regulation .06 amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .10A amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Chapter revised effective March 9, 1998 (25:5 Md. R. 369) **Administrative History:** Regulation .01-1 amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulation .02 amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulation .06B, D, F amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulation .07A amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulation .10C amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulation .11 amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulation .12B, D amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulation .13A, D amended effective October 18, 1999 (26:21 Md. R. 1629) **Administrative History:** Regulations .01—.14 repealed and new Regulations .01—.14 adopted effective August 21, 2000 (27:16 Md. R. 1525) **Administrative History:** Regulation .13 amended effective December 23, 2002 (29:25 Md. R. 1983) **Administrative History:** Regulations .01—.14 repealed and new Regulations .01—.17 adopted effective April 19, 2010 (37:8 Md. R. 617) **Administrative History:** Regulations .01—.17 repealed and new Regulations .01—.19 adopted as an emergency provision effective January 9, 2014 (41:3 Md. R. 200); adopted permanently effective March 17, 2014 (41:5 Md. R. 344) **Administrative History:** Chapter revised effective October 18, 2021 (48:21 Md. R. 889) #### Regulation .01 Scope and Purpose. *COMAR 10.25.06.01* These regulations establish appropriate methods for collecting and compiling Statewide data on selected health care services provided either under a Maryland contract or to Maryland residents by health care practitioners and facilities: A. From payors; B. From third-party administrators; C. From managed behavioral health care organizations; D. From pharmacy benefit managers; and E. Regarding providers for whom the Maryland Health Care Commission otherwise receives data. #### Regulation .02 Definitions. *COMAR 10.25.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adjudicated” means paid, resolved, or settled. (2) “Behavioral health care services” means procedures or services rendered by a health care practitioner for the treatment of mental health or substance use disorders. (3) “Capitated encounter” means a health care visit in which a health care practitioner or office facility provides a service pursuant to an agreement with a reporting entity for reimbursement on an aggregate fixed sum or per capita basis. (4) “Commission” means the Maryland Health Care Commission. (5) “Crosswalk” means a list of all codes and their definitions in a separate file that maps to a specific data field. (6) “Executive Director” means the Executive Director of the Maryland Health Care Commission. (7) “Fee-for-service encounter” means a health care visit in which a health care practitioner or office facility provided a health care service for which a claim was submitted to a reporting entity for payment, and payment was made on a per service basis. (8) “General health benefit plan” means: (a) A hospital or health care policy, contract, or certificate issued by a payor as defined in this section; (b) A behavioral health services plan; (c) A pharmacy benefit management services plan; (d) A vision plan certified by the Maryland Health Benefit Exchange; or (e) A dental plan certified by the Maryland Health Benefit Exchange. (9) “Health Benefit Exchange” or “Exchange” means the Maryland Health Benefit Exchange established as a public corporation under Insurance Article, §31-102, Annotated Code of Maryland, and includes the Individual Exchange and the Small Business Health Operations Program (SHOP) Exchange. (10) “Health care service” means a health or medical care procedure or service rendered by a health care practitioner that: (a) Provides testing, diagnosis, or treatment of human disease or dysfunction; or (b) Dispenses drugs, medical devices, medical appliances, or medical goods for the treatment of human disease or dysfunction. (11) “Health information exchange” or “HIE” means an entity that creates or maintains an infrastructure that provides organizational and technical capabilities in an interoperable system for the electronic exchange of protected health information among participating organizations not under common ownership, in a manner that ensures the secure exchange of protected health information to provide care to patients. An HIE does not include an entity that is acting solely as a health care clearinghouse, as defined in 45 CFR §160.103. A payor may act as, operate, or own an HIE subject to these regulations. (12) “HIPAA” means the U.S. Health Insurance Portability and Accountability Act of 1996, P.L.104-191, as implemented and amended in federal regulations, including the HIPAA Privacy and Security rules, 45 CFR §§160 and 164, as may be amended, modified, or renumbered and including as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act. (13) “Managed behavioral health care organization” means a company, organization, private review agent, or subsidiary that: (a) Contracts with a payor as defined in this section to provide, undertake to arrange, or administer behavioral health care services to members; or (b) Otherwise makes behavioral health care services available to members through contracts with health care providers. (14) “Managed care organization” or “MCO” means: (a) A certified health maintenance organization that is authorized to receive medical assistance prepaid capitation payments; or (b) A corporation that: (i) Is a managed care system that is authorized to receive medical assistance prepaid capitation payments; (ii) Enrolls only program recipients or individuals or families served under the Maryland Children's Health Program; and (iii) Is subject to the requirements of Health-General Article, §15-102.4, Annotated Code of Maryland. (15) “Master Patient Index” means a database that maintains a unique index identifier for each patient whose protected health information may be accessible through the HIE and is used to cross reference patient identifiers across multiple participating organizations to allow for patient search, patient matching, and consolidation of duplicate records. (16) “Medical Care Data Base” or “MCDB” means the data base established and maintained by the Commission pursuant to Health-General Article, §19-133, Annotated Code of Maryland, that collects eligibility data, professional services claims, institutional services claims, pharmacy claims, and provider data for Maryland residents enrolled in private insurance, Medicaid, or Medicare. The MCDB is Maryland’s All Payer Claims Data Base. (17) “MCDB Submission Manual” or “Manual” means the composition of data reporting requirements with guidelines of technical specifications, layouts, and definitions necessary for filing the reports required by this chapter. (18) “Non-Fee-for-Service Expenses Report” means a report with information on lump sum payments made by a reporting entity to providers as part of the reporting entity’s compensation to the providers for non-claims-based services. (19) “Office facility” means a freestanding facility providing: (a) Ambulatory surgery; (b) Radiologic or diagnostic imagery; or (c) Laboratory services. (20) “Payor” means: (a) An insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in Maryland; (b) A health maintenance organization (HMO) that holds a certificate of authority in Maryland; or (c) For Medical Care Data Base purposes: (i) A third-party administrator registered under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland; (ii) A managed behavioral health care organization as defined in this section; or (iii) A pharmacy benefit manager. (21) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, representative of any kind, partnership, firm, association, corporation, or other entity. (22) “Pharmacy benefit management services” means: (a) The procurement of prescription drugs at a negotiated rate for dispensation within the State to beneficiaries; (b) The administration or management of prescription drug coverage provided by a purchaser for beneficiaries; and (c) Any of the following services provided with regard to the administration of prescription drug coverage: (i) Mail service pharmacy; (ii) Claims processing, retail network management, and payment of claims to pharmacies for prescription drugs dispensed to beneficiaries; (iii) Clinical formulary development and management services; (iv) Rebate contracting and administration; (v) Patient compliance, therapeutic intervention, and generic substitution programs; or (vi) Disease management programs. (d) “Pharmacy benefit management services” does not include any service provided by a nonprofit health maintenance organization that operates as a group model, provided that the service is provided solely to a member of the nonprofit health maintenance organization and is furnished through the internal pharmacy operations of the nonprofit health maintenance organization. (23) “Pharmacy benefit manager” means a person who performs pharmacy benefit management services and is registered as a pharmacy benefit manager under Insurance Article, Title 15, Subtitle 16, Annotated Code of Maryland. (24) “Practitioner” means a person who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession or in an approved education or training program. (25) “Practitioner federal tax ID number” means the federal tax identification number of the practitioner, practice, supplier or office facility receiving reimbursement for the service provided. (26) “Practitioner/supplier ID number” means the unique identification number used by the reporting entity to identify the particular practitioner or supplier. (27) “Primary diagnosis” means the principal diagnosis for the health care service visit. (28) "Provider” means: (a) A practitioner; (b) A facility where health care is provided to patients or recipients, including: (i) A facility, as defined in Health-General Article, §10-101(e), Annotated Code of Maryland; (ii) A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (iii) A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (iv) A health maintenance organization, as defined in Health-General Article, §19-701(g), Annotated Code of Maryland; (v) An outpatient clinic; and (vi) A medical laboratory; or (c) The agents and employees of a facility who are licensed or otherwise authorized to provide health care, the officers and directors of a facility, and the agents and employees of a health care provider who are licensed or otherwise authorized to provide health care. (29) “Qualified dental plan” means a dental plan certified by the Maryland Health Benefit Exchange that provides limited scope dental benefits, as described in §1311(c) of the Affordable Care Act and Insurance Article, §31-115, Annotated Code of Maryland. (30) “Qualified health plan” means a general health benefit plan that has been certified by the Maryland Health Benefit Exchange to meet the criteria for certification described in §1311(c) of the Affordable Care Act and Insurance Article, §31-115, Annotated Code of Maryland. (31) “Qualified vision plan” means a vision plan certified by the Maryland Health Benefit Exchange that provides limited scope vision benefits, as described in the Insurance Article, §31-108(b)(3), Annotated Code of Maryland. (32) “Reporting entity” means a payor, third-party administrator, managed behavioral health care organization, or pharmacy benefit manager that is designated by the Commission to provide reports consistent with this chapter to be collected and compiled into the Medical Care Data Base. (33) “State-designated health information exchange” or “State-designated HIE” means an HIE designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth in Health-General Article, §19-143, Annotated Code of Maryland. (34) “Supplier” means a person or entity, including a health care practitioner, which supplies medical goods or services. (35) “Third-party administrator” means a person that is registered as an administrator under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland. #### Regulation .03 Persons Designated to Provide Data to the Commission. *COMAR 10.25.06.03* A. Reporting Entities. By December 31 of each year, the Commission shall make available a list of each payor, third-party administrator, pharmacy benefit manager, and managed behavioral health care organization meeting the criteria for designation as a reporting entity and who shall file the reports under this chapter in the following year. (1) The Commission shall designate as a reporting entity each payor and third-party administrator whose total lives covered exceeds 1,000, as reported to the Maryland Insurance Administration. (2) The Commission shall designate as a reporting entity each payor offering a qualified health plan, qualified dental plan, or qualified vision plan certified by the Maryland Health Benefit Exchange, under Insurance Article, §31-115, Annotated Code of Maryland. (3) The Commission shall designate as a reporting entity each payor that is a managed care organization participating in the Maryland Medical Assistance Program in connection with the enrollment of an individual in the Maryland Medical Assistance Program or the Maryland Children's Health Program. (4) The Commission may conduct surveys as needed to fulfill the purposes of the MCDB. (a) The Commission may conduct a survey of any reporting entity to determine if the reporting entity is required to report data or for other purposes consistent with this chapter. (b) If necessary, the Commission may institute an annual survey to obtain information needed to determine and designate a third-party administrator whose annual covered lives report filed with the Maryland Insurance Administration does not delineate the number of covered lives for the following: (i) A behavioral health services plan; or (ii) A pharmacy benefit management services plan. (c) A reporting entity shall timely report information sought by the Commission in a survey. B. Data Otherwise Collected by the Commission from Reporting Entities or Providers. (1) A reporting entity’s reports are considered submitted to the Commission if the reports are contained within the submission of another reporting entity. (2) For purposes of supplementing the MCDB, the Commission may include information that the Commission has otherwise received regarding providers and services. C. Data Collected from other State or Federal Agencies. The Commission designates and selects any data obtained from a state or federal agency to be a part of the MCDB for use consistent with this chapter. #### Regulation .04 Process for Submitting Data. *COMAR 10.25.06.04* A. The Commission shall provide each reporting entity with an annual update to the MCDB Submission Manual, and each current Manual update available, as specified in Regulation .15 of this chapter. B. Each reporting entity shall provide each of the following reports, if applicable: (1) Professional Services Data Report; (2) Pharmacy Data Report; (3) Provider Directory Report; (4) Institutional Services Data Report; (5) Eligibility Data Report; (6) Plan Benefit Design Report; (7) Dental Services Data Report; and (8) Non-Fee-for-Service Expenses Report. C. An MCO shall provide each required report to the Commission through the Maryland Medical Assistance Program, which will provide the MCO reports and related information to the Commission. #### Regulation .05 Time Period for Submitting Data Reports. *COMAR 10.25.06.05* A. Unless a different reporting time period is specified in the MCDB Submission Manual pursuant to §B of this regulation, each reporting entity shall submit to the Commission a complete set of the entity’s data for claims paid during each quarter of a calendar year in the form and manner described in Regulations .07—.14 of this chapter within 2 months of the last day in the applicable quarter. B. Each reporting entity shall submit at least quarterly to the Commission a complete set of the reporting entity’s data for claims paid during the specific time period in the form and manner described in Regulations .07—.14 of this chapter and within the time period specified in the MCDB Submission Manual, unless a more frequent submission schedule is instituted by the Commission pursuant to §C of this regulation. C. Before instituting a requirement that a reporting entity submit data for claims paid more frequently than quarterly, as required in §§A and B of this regulation, the Commission shall: (1) Establish a multi-stakeholder group consisting of representatives of reporting entities, involved State agencies, and other stakeholders, as appropriate, to discuss the benefits and costs of expanding data collection; and (2) Include a transition period for reporting entities to adjust to the new data submission schedule and process. #### Regulation .06 Protection of Confidential Information in Submissions. *COMAR 10.25.06.06* A. To assure that confidential records or information are protected, each reporting entity shall encrypt each of the following data elements in such a manner that each unique value for a data element produces an identical unique encrypted data element: (1) Patient or enrollee identifier; and (2) Internal subscriber contract number. B. In order to maintain a consistent and unique identifier for each patient across providers, payors, and services, the Commission shall: (1) Provide selected data to the State-designed HIE for the creation and encryption of a Master Patient Index; and (2) Include Master Patient Index identifiers received from the State-designated HIE in each eligibility data report submitted under Regulation .11 of this chapter. C. Each reporting entity shall maintain the security and preserve the confidentiality of the encrypted data. #### Regulation .07 Professional Services Data Report Submission. *COMAR 10.25.06.07* A. Each reporting entity shall submit a professional services data report that provides the data for each fee-for-service and capitated encounter, including fee-for-service equivalents prices for capitated services, provided by a health care practitioner or office facility. This report shall include all health care services provided: (1) To each Maryland resident insured by that entity under a fully insured or a self-insured contract; and (2) To each non-Maryland resident insured under a Maryland contract. B. Each professional services data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .08 Pharmacy Data Report Submission. *COMAR 10.25.06.08* A. Each reporting entity shall submit a pharmacy data report for each prescription drug encounter for services provided by a pharmacy located in or out of the State. This report shall include all pharmacy services provided to each Maryland resident insured under a fully insured contract or a self-insured contract, and to each non-Maryland resident insured under a Maryland contract. B. Each pharmacy data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .09 Provider Directory Report Submission. *COMAR 10.25.06.09* A. Each reporting entity shall submit a provider directory report detailing each health care practitioner or supplier that provided services to any enrollee of that reporting entity during the reporting period. This report shall contain information for each in-State Maryland practitioner or supplier, and for each out-of-State practitioner or supplier that has served a Maryland resident or a non-Maryland resident under a Maryland contract. B. Each provider directory report shall include a crosswalk to each practitioner or supplier ID listed in the professional services data report submitted under Regulation .07 of this chapter or the pharmacy data report submitted under Regulation .08 of this chapter. C. Each provider directory report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .10 Institutional Services Data Report Submission. *COMAR 10.25.06.10* A. Each reporting entity shall submit an institutional services data report that reports all institutional health care services provided to each Maryland resident insured under a fully insured contract or self-insured contract, and each non-Maryland resident insured under a Maryland contract, whether those services were provided: (1) By a health care facility located in-State or out-of-State; or (2) Under a general health benefit plan. B. Each institutional services data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .11 Eligibility Data Report Submission. *COMAR 10.25.06.11* A. Each reporting entity shall submit an eligibility data report that provides information on the characteristics of each enrollee that is a Maryland resident insured under a fully insured contract or a self-insured contract, and each enrollee that is a non-Maryland resident insured under a Maryland contract, for services covered under each policy or contract issued by the reporting entity that are subject to this chapter. B. Each eligibility data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .12 Plan Benefit Design Report. *COMAR 10.25.06.12* Each plan benefit design report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .13 Dental Services Data Report. *COMAR 10.25.06.13* Each dental services data report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .14 Non-Fee-for-Service Expenses Report. *COMAR 10.25.06.14* Each non-fee-for-service expenses report shall contain the information specified by the Commission in its annual update to the MCDB Submission Manual and be filed in a form and manner specified in the Manual. #### Regulation .15 Report Submission Methods. *COMAR 10.25.06.15* A. When a reporting entity collects more granular information than required under this chapter, the reporting entity shall provide a conversion table that describes how internal values are mapped to each required category. B. The MCDB Submission Manual shall contain technical specifications, layouts, required reports, and definitions for each reporting entity. (1) The Commission shall provide an annual MCDB Submission Manual by November 21 of each year to be used for the reporting periods in the subsequent year. (2) The Commission may correct incomplete or erroneous information in the MCDB Submission Manual as necessary, and provide notice of each correction on the Commission website and by email to the contact persons designated by the reporting entities. (3) The Commission shall timely post the annual MCDB Submission Manual on the Commission website and provide notice in the Maryland Register. C. Master Patient Index. (1) The Commission may require that each reporting entity electronically submit sufficient demographic information on each enrollee to create a Master Patient Index. (2) The Commission may require that a reporting entity provide the information required under §C(1) of this regulation to the State-designated HIE solely for the purpose of creating a Master Patient Index. (3) The information required under §C(1) of this regulation shall be submitted in a manner consistent with all relevant federal and State privacy laws and regulations. #### Regulation .16 Request for an Extension of Time. *COMAR 10.25.06.16* A. A reporting entity may request an extension of an additional 30 days time to provide the required data report. B. For a 30-day extension request to be considered by Commission staff, the reporting entity shall submit a written request to the Executive Director at least 30 days before the required submission date that includes: (1) The extraordinary cause necessitating the extension request; and (2) A proposed date, which is no more than 30 days after the initial required submission date, when the reporting entity will provide the required data to the Commission. #### Regulation .17 Request for an Annual Waiver or Format Modification. *COMAR 10.25.06.17* A. Annual Waiver Request. (1) When a reporting entity is not able to submit a data report as set forth in this chapter, the reporting entity shall file with the Commission by March 15 of the year for which a waiver is sought a written request for an annual waiver that shall include an explanation of why the reporting entity is not able to provide the data report, including any extraordinary circumstances. (2) Supporting Documentation Required for an Annual Waiver Request. (a) A general health benefit plan shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000, as reported to the Maryland Insurance Administration. (b) A qualified health benefit plan, a qualified vision plan or a qualified dental plan shall include a relevant document from the Health Benefit Exchange indicating that the entity’s filing of the data is not required. (c) A third party administrator shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000, as reported to the Maryland Insurance Administration. (d) A behavioral health care services organization shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000, as reported to the Maryland Insurance Administration. (e) A pharmacy benefit manager shall include an affidavit from an officer of the organization stating that its total lives covered does not exceed 1,000. B. Format Modification Request. When a reporting entity is not able to provide all the information required in Regulations .07—.14 of this chapter, the reporting entity shall file with the Commission a written request for a format modification at least 30 days before the applicable submission date that shall include: (1) The extraordinary circumstances surrounding the reporting entity’s inability to submit values for a specific data element; (2) An explanation of each reason why a format modification is necessary; and (3) A detailed description of the reporting entity’s proposed layout or submission method, or both, when applicable. C. The Executive Director shall provide the reporting entity with a written decision within 30 days of the filing of a completed request. D. Appeal of the Executive Director’s Decision. The aggrieved party may file a written request for Commission review of the Executive Director’s written decision within 14 days of the decision. (1) The Commission may provide an opportunity for the reporting entity to present argument to the Commission. (2) The Commission may affirm, reverse, or modify the decision of the Executive Director. (3) The decision by the Commission shall be by a majority of the quorum present and voting. #### Regulation .18 Failure to File Data Reports. *COMAR 10.25.06.18* A. A reporting entity that does not timely file a data report in compliance with the MCDB Submission Manual may be subject to monetary penalties as provided in COMAR 10.25.12. B. In accordance with COMAR 10.25.12.01C, a data report that is substantially incomplete or inaccurate is not timely filed within the meaning of §A of this regulation and may be subject to monetary penalties as provided in COMAR 10.25.12. #### Regulation .19 Summaries and Compilations. *COMAR 10.25.06.19* The Commission shall develop public-use data, summaries, and compilations for public disclosure, pursuant to Health-General Article, §§19-103(c)(3), 19-109(a)(6), and 19-134, Annotated Code of Maryland, in compliance with all applicable federal and State laws and regulations. ### Chapter 07 — Certification of Electronic Health Networks and Medical Care Electronic Claims Clearinghouses **Authority:** Health-General Article, §§4-302.1, 4-302, 4-302.2—.3, 4-302.5, 19-103(c)(2), (9) and (10), 19-109(a)(1) and (8), 19-133(d), 19-134, and 19-135(a) and (b), Annotated Code of Maryland **Administrative History:** Effective date: July 15, 1996 (23:14 Md. R. 1008) **Administrative History:** Regulation .01 amended effective July 23, 2001 (28:14 Md. R. 1322) **Administrative History:** Regulation .02 amended effective April 3, 2000 (27:6 Md. R. 641) **Administrative History:** Regulation .03 amended effective July 23, 2001 (28:14 Md. R. 1322) **Administrative History:** Regulation .05 amended effective April 15, 2002 (29:7 Md. R. 620) **Administrative History:** Regulation .10 amended effective July 23, 2001 (28:14 Md. R. 1322) **Administrative History:** Regulation .11 amended effective April 3, 2000 (27:6 Md. R. 641); December 23, 2002 (29:25 Md. R. 1983) **Administrative History:** Regulations .01—.11 repealed and new Regulations .01—.11 adopted effective March 24, 2008 (35:6 Md. R. 698) **Administrative History:** Regulation .02B amended effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .02B amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .04A amended effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .04B amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .05A amended effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .05A amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .06A, D amended effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Regulation .09 amended as an emergency provision effective January 11, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .09C amended effective December 15, 2008 (35:25 Md. R. 2150) **Administrative History:** Chapter revised effective November 10, 2025 (52:22 Md. R. 1095) #### Regulation .01 Scope. *COMAR 10.25.07.01* A. This chapter provides for the certification of electronic health networks and medical care electronic claims clearinghouses that operate in Maryland. Payors that accept electronic health care transactions originating in Maryland may only accept electronic health care transactions from electronic health networks or medical care electronic claims clearinghouses that obtain certification pursuant to this chapter. B. This chapter applies to: (1) An electronic health network, as defined in Regulation .02 of this chapter; and (2) The State-designated health information exchange or State-designated HIE as designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland.. #### Regulation .02 Definitions. *COMAR 10.25.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adjudication of claims” means the activities necessary for the adjudication or subrogation of a health benefit claim that has been filed or may be filed by a patient, or with the authorization of a patient on the patient’s behalf, including: (a) Determinations of eligibility or coverage, including coordination of benefits or the determination of cost-sharing amounts; (b) Reasonable prospective, concurrent, or retrospective utilization review or predetermination of benefit coverage; (c) Review, audit, and investigation of a specific claim for payment of benefits with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges; (d) Billing, claims management, collection activities, obtaining payment under a contract for reinsurance, and related health care data processing; and (e) Risk adjustments based on enrollee health status and demographic characteristics. (2) “Commission” means the Maryland Health Care Commission. (3) “Disclose” or “disclosure” means the release, redisclosure, transfer, provision, access, transmission, communication, or divulgence in any other manner of health information, including an acknowledgement that a health record on a particular patient or recipient exists outside the entity holding the information. (4) “Electronic health care transactions” means health care transactions that have been approved by a nationally recognized health care standards development organization (SDO) to support health care informatics, information exchange, systems integration, and other health care applications. (5) “Electronic Health Network (EHN)” means an entity involved in the exchange of electronic health care transactions between electronic health networks, payors, providers, vendors, or other entities. (6) “Entity” means a partnership, firm, association, limited liability company, limited liability partnership, or a public or private corporation. (7) “Grievance” means a written complaint or other information received by the Commission indicating that an MHCC-certified EHN may have violated one of the provisions of Regulation .09 of this chapter. (8) “Health information” means any information, whether oral or recorded in any form or medium, including electronic health information, that: (a) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, or health care clearinghouse; and (b) Relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual. (9) “Improvement of patient safety” means actions, strategies, or protocols to prevent health care errors, enhance the quality of care, and ensure a safe health care environment. (10) “Legally protected health information” means the health information with a date of service after May 31, 2022, that is subject to restrictions under Health-General Article, §4-302.5, Annotated Code of Maryland, and COMAR 10.11.08, including: (a) Mifepristone data, as defined by the Secretary; and (b) As specified by the Secretary, the diagnosis, procedure, medication, and other codes related to: (i) Abortion care; and (ii) Sensitive health services, as defined by Health-General, §4-301, Annotated Code of Maryland. (11) Medical Care Electronic Claims Clearinghouse. (a) “Medical care electronic claims clearinghouse” is an entity that transmits electronic health care transactions. (b) “Medical care electronic claims clearinghouse” includes an electronic health network. (12) “MHCC” means the Maryland Health Care Commission. (13) “MHCC-Certified Electronic Health Network” means an entity that has received certification from the Maryland Health Care Commission. (14) “Mitigation of a public health emergency” means taking actions to lessen the impact of a public health emergency and reduce harm, including implementing preventive measures, managing resources, and coordinating responses to limit disease spread, minimize health risks, and support affected communities effectively. (15) “Payor” means an entity that administers or provides reimbursement for health care benefits on an expense-incurred basis, including: (a) A health maintenance organization issued a certificate of authority in accordance with Health-General Article, Title 19, Subtitle 7, Annotated Code of Maryland; (b) A health insurer or nonprofit health service plan authorized to offer health insurance policies or contracts in this State in accordance with Insurance Article, Title 14, Annotated Code of Maryland; (c) A third-party administrator registered under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland; (d) An entity that subcontracts with a third-party payor to provide specialty health care services including, but not limited to, a dental benefit payor, a vision benefit payor, a mental health benefit payor, and a pharmacy benefit manager; or (e) A managed care organization that contracts with the Maryland Medical Assistance program to provide health services to Maryland Medical Assistance recipients in accordance with Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland. (16) “State-designated health information exchange” or “State-designated HIE” means a health information exchange designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland. (17) “State health improvement program” means a State initiative designed to enhance public health through strategic planning, targeted interventions, and collaboration with stakeholders and the federal government, including State efforts in support of the Total Cost of Care model and successor models agreed to by the federal government and the State. (18) “Qualified accreditation or certification organization” means a nationally recognized entity that has established privacy and security standards for electronic health networks and accredits or certifies networks that meet those standards. #### Regulation .03 Duration of Certification. *COMAR 10.25.07.03* A certification is valid for a 2-year period from the date of certification unless withdrawn by the Commission prior to the end of the 2-year period. #### Regulation .04 Procedure to Obtain Certification. *COMAR 10.25.07.04* A. Application for Certification. An EHN seeking Commission certification shall: (1) Complete and submit an application for MHCC Electronic Health Network Certification in the form and manner specified by the Commission; (2) Provide evidence that it has been granted either candidacy status or full accreditation or certification status by a qualified accreditation or certification organization; and (3) Meet all Commission certification requirements set forth in Regulation .05 of this chapter. B. Fees. (1) An application fee shall be paid to the Commission within 30 days of receipt of an invoice from the Commission. (2) For an electronic health network with one operational site, an application fee of $400 shall be paid within 30 days of receipt of an invoice from the Commission. (3) For an electronic health network with more than one operational site, an application fee of $400, plus a $200 fee for each additional operational site, shall be paid within 30 days of receipt of an invoice from the Commission. #### Regulation .05 Standards for Certification. *COMAR 10.25.07.05* A. In order to obtain certification, an applicant shall: (1) Provide evidence that the applicant is accredited or certified by a qualified accreditation or certification organization; and (2) Meet the following standards for certification: (a) Demonstrate compliance with the HIPAA privacy standards set forth in 45 CFR Parts 160 and 164; (b) Demonstrate compliance with HIPAA security standards set forth in 45 CFR Parts 160, 162, and 164; (c) Provide an attestation signed by an officer of the applicant that to the extent required by Health-General Article, §4-302.5, Annotated Code of Maryland, the applicant: (i) Possesses the technological capability to filter and restrict from disclosure legally protected health information; (ii) Is parsing restricted codes and conveying all other information in the health record that is not prohibited by law to exchange; and (iii) Possesses the technological capacity to allow a consumer to request and consent to the exchange of legally protected health information to a specific treating provider; (d) Provide evidence of ability to measure technical performance and manage future capacity demands; (e) Provide evidence of initial and ongoing employee training in HIPAA privacy and security requirements and customer communication procedures; and (f) Provide additional information requested by the Commission as necessary to determine the applicant's compliance with the standards for certification. B. The Commission shall issue certification to an applicant that has met all the requirements of §A of this regulation. #### Regulation .06 Candidacy Status. *COMAR 10.25.07.06* A. Subject to the provisions of this section, the Commission shall issue candidacy status to an applicant that: (1) Has been granted candidacy status by a qualified accreditation or certification organization; (2) Has submitted an application for certification to the Commission; (3) Has paid the application fee; and (4) Has submitted documentation satisfactory to the Commission demonstrating compliance with the requirements set forth in Regulation .05B of this chapter. B. The Commission shall issue candidacy status to an applicant that has met all the requirements of §A of this regulation. C. An applicant that has achieved candidacy status may transmit electronic health care transactions while completing the certification requirements of this chapter. D. Candidacy status expires on the expiration of the applicant's candidacy status with a qualified accreditation or certification organization, on the approval of certification by the Commission, or 2 years from the date that candidacy status was issued. #### Regulation .07 Notice Required. *COMAR 10.25.07.07* A. Within 30 days after the closure, sale, lease, assignment, or transfer of an MHCC-certified EHN to any person or entity, the MHCC-certified EHN and the other party to the transaction shall notify the Commission of that event. Upon such notice, the Commission may seek further information to determine whether the certification should remain in effect notwithstanding the sale or other event. B. At least 60 days before changing its address, an MHCC-certified EHN shall notify the Commission of its intent and provide the Commission with the new address. C. At least 60 days before changing its name, an MHCC-certified EHN shall notify the Commission of its intent to change its name and provide the Commission with the new name. #### Regulation .08 Renewal of Certification. *COMAR 10.25.07.08* A. Application for renewal of certification shall be made at least 60 days before the expiration of the certification in a form and manner specified by the Commission. B. A recertification fee shall be paid to the Commission at the time the MHCC Electronic Health Network recertification application is filed. C. For an electronic health network with one operational site, a recertification fee of $250 shall be paid at the time the application is filed. D. For an electronic health network with more than one operational site, a recertification fee of $250, plus a $125 fee for each additional operational site, shall be paid at the time the application is filed. E. The Commission shall renew the certification of each renewal applicant that continues to meet the standards set forth in Regulation .05 of this chapter. F. The Commission shall issue a renewal of certification to an applicant that has met all the requirements of this regulation. #### Regulation .09 Electronic Health Network Transaction Submission. *COMAR 10.25.07.09* A. An MHCC-certified EHN shall submit electronic health care transactions information in accordance with this regulation to the State-designated HIE for public health and clinical purposes to facilitate: (1) A State health improvement program; (2) Mitigation of a public health emergency; (3) Improvement of patient safety; or (4) The participation of the State in the Center for Medicare and Medicaid Innovation’s Achieving Healthcare Efficiency through Accountable Design (AHEAD) model and any successor models. B. Transactions to be Submitted. (1) An MHCC-certified EHN shall submit electronic health care transactions information for services delivered in Maryland to the State-designated HIE that consist of the following transactions: (a) Health care claim or equivalent encounter information (837P and 837I); and (b) Health plan eligibility inquiry and response (270). (2) Only the EHN that receives the transaction from or returns the transaction to the originating submitter directly is required to submit the transaction information to the State-designated HIE. C. The Commission may request the submission of other electronic administrative transactions adopted by the Department of Health and Human Services. D. An MHCC-certified EHN may include transactions related to pharmaceuticals covered by medical benefits with its submission under §B of this regulation if excluding that data would be burdensome. E. Electronic Health Care Transactions Technical Submission Guidance. (1) In consultation with stakeholders, including Commission staff, the State-designated HIE shall develop an Electronic Health Care Transactions Technical Submission Guidance that: (a) Contains detailed technical requirements for submitting electronic health care transaction information to the State-designated HIE; (b) Provides an option for MHCC-certified EHNs to submit electronic health care transactions in a flat file; and (c) To the extent possible, utilizes industry recognized standards. (2) The State-designated HIE shall: (a) Invite all MHCC-certified EHNs and Commission staff to at least one meeting to discuss the initial development of the Electronic Health Care Transactions Technical Submission Guidance; (b) Invite all MHCC-certified EHNs and Commission staff to at least one meeting prior to making any material updates to the Electronic Health Care Transactions Technical Submission Guidance; (c) Solicit public comments on a draft copy of the initial Electronic Health Care Transactions Technical Submission Guidance, and any material updates to the guidance, by: (i) Publishing the draft guidance on its website; and (ii) Sending the draft guidance to MHCC-certified EHNs and the Commission by e-mail; (d) Accept comments on the draft Electronic Health Care Transactions Technical Submission Guidance for at least 30 days; (e) Publish a written response to any significant, substantive issues raised in comments; and (f) Consider all stakeholder feedback prior to finalizing the Electronic Health Care Transactions Technical Submission Guidance. (3) The State-designated HIE shall annually submit to Commission staff a final draft of the Electronic Health Care Transactions Technical Submission Guidance for approval, which shall not be unreasonably denied. (4) The State-designated HIE and the Commission shall publish the final, approved Electronic Health Care Transactions Technical Submission Guidance on their websites. (5) An MHCC-certified EHN shall submit electronic health care transaction information to the State-designated HIE in a manner detailed in the most recent version of the Electronic Health Care Transactions Technical Submission Guidance. F. Submission Schedule. (1) No later than the last business day of each month, an MHCC-certified EHN shall submit electronic health care transactions information from the preceding month to the State-designated HIE. (2) An MHCC-certified EHN shall submit electronic health transaction information at least once per month, but may submit data more often. G. An EHN may not charge a fee to a health care provider, health care payor, or the State-designated HIE for providing the information required under this regulation. H. Exemptions. (1) An MHCC-certified EHN may request a 1-year exemption from certain reporting requirements in this regulation. (2) An exemption request shall: (a) Be in writing; (b) Identify each specific requirement of this regulation from which the EHN is requesting an exemption; (c) Identify the time period of the exemption, if any; (d) State the reason for each exemption request; and (e) Include information that justifies the exemption request. (3) Within 45 days after receipt of complete information from an EHN requesting an exemption, the Commission shall take one of the following actions: (a) Grant the exemption by providing written notification; or (b) Deny the exemption request by providing written notification that enumerates the reasons for the denial to the EHN. (4) The Commission may not exempt an MHCC-certified EHN from any requirement within this regulation that is otherwise required by federal or other State law. (5) The Commission may grant an exemption on the following grounds: (a) The absence of functionality in the infrastructure of the EHN that prevents the EHN from complying with the requirement; (b) The requirement would hinder the ability of the EHN to comply with other requirements of this chapter or federal or other State laws; or (c) The requirement would cause an undue burden or hardship on the EHN, such that the EHN would no longer be able to provide EHN services in the State. (6) For good cause shown, the Commission may renew a 1-year exemption for an additional 1-year period. I. Effective Date. (1) The State-designated HIE shall publish the Electronic Health Care Transactions Technical Submission Guidance within 12 months of the final effective date of this regulation. (2) An MHCC-certified EHN shall begin submitting electronic health care transaction information based on the most recent version of the Electronic Health Care Transactions Technical Submission Guidance within 18 months following the initial publication of the Electronic Health Care Transactions Technical Submission Guidance. J. Implementation Reporting. (1) Upon request, the State-designated HIE shall submit to the Commission updates on: (a) Its status of developing the Electronic Health Care Transactions Technical Submission Guidance; (b) Its progress in supporting MHCC-certified EHN implementation of the Electronic Health Care Transactions Technical Submission Guidance; and (c) Any disruptions or technology failures that delay implementation and associated impacts, if any. (2) An MHCC-certified EHN shall submit to the Commission at least quarterly: (a) An implementation plan and timeline detailing progress the MHCC-certified EHN has made towards submitting electronic health care transaction information to the State-designated HIE; and (b) Any other information requested by the Commission related to the implementation of this regulation. #### Regulation .10 Withdrawal of Certification and Other Penalties. *COMAR 10.25.07.10* A. The Commission may withdraw certification from an MHCC-certified EHN if the Commission finds that: (1) The MHCC-certified EHN fails to meet the certification standards set forth in Regulation .05 of this chapter; (2) A principal or owner of the MHCC-certified EHN, or the entity itself, is convicted of, or pleads guilty or nolo contendere to, a crime related to the operation of the EHN or to a crime involving financial improprieties; (3) A principal or owner of the MHCC-certified EHN, or the entity itself, is notified by a qualified accreditation or certification organization or the Commission of a violation of HIPAA privacy or security standards and fails to take action to remedy the violation within the period of time specified by a qualified accreditation or certification organization or by the Commission; (4) The MHCC-certified EHN disclosed legally protected health information in violation of Health-General Article, §4-302.5, Annotated Code of Maryland; or (5) The MHCC-certified EHN fails to submit electronic health care transactions information to the State-designated HIE in accordance with Regulation .09 of this chapter. B. Beginning June 1, 2024, a person who knowingly violates Health-General Article, §4-302.5, Annotated Code of Maryland, shall be guilty of a misdemeanor and on conviction is subject to a fine not to exceed $10,000 per day based on: (1) The extent of actual or potential public harm caused by the violation; (2) The cost of investigating the violation; and (3) The person’s prior record of compliance. C. A MHCC-certified EHN that fails to submit electronic health transactions information to the State-designated HIE in accordance with Regulation .09 of this chapter may be subject to a financial penalty not to exceed $10,000 per day based on: (1) The extent of actual or potential public harm caused by the violation; (2) The cost of investigating the violation; and (3) Whether the MHCC-certified EHN committed previous violations. #### Regulation .11 Notice Prior to Withdrawal. *COMAR 10.25.07.11* A. Before withdrawal of certification on one of the bases provided in Regulation .10 of this chapter, the Executive Director shall inform the MHCC-certified EHN, setting forth in writing the reasons for withdrawal. B. The notice of withdrawal shall set forth the right of the MHCC-certified EHN to an evidentiary hearing, conducted in accordance with Regulation .12 of this chapter, to show cause why the certification should not be withdrawn. C. Within 15 days of receipt of the notice of withdrawal, the MHCC-certified EHN may make a written filing that details the EHN's position and provides supporting documentation, before the Commission takes final action to withdraw the EHN's certification. #### Regulation .12 Hearing Procedures. *COMAR 10.25.07.12* A. Reviewer as Presiding Officer. (1) If an evidentiary hearing is requested, the Executive Director shall appoint a single commissioner to act as reviewer and preside at the hearing. (2) The reviewer shall hold a prehearing conference, at which the reviewer shall: (a) Summarize the rules of procedure governing the evidentiary hearing; (b) Determine the date, time, and place of the evidentiary hearing; (c) Determine the form and manner of the presentation of evidence; (d) Rule on any pending motions; and (e) Make other decisions as appropriate. B. Hearing. The reviewer is empowered to: (1) Make all rulings as to evidence, testimony, and the conduct of the evidentiary hearing; and (2) Take other actions consistent with the duties of a reviewer. C. Proposed Decision. The reviewer shall prepare a proposed decision and order which shall state the reviewer's determination as to whether the allegations that formed the basis for the hearing are substantiated or not, and if substantiated, include a proposed sanction. D. Exceptions. (1) If the proposed decision is adverse to the MHCC-certified EHN, the EHN may submit written exceptions to the proposed decision and order by submitting written argument with citation to supporting documentation from the record. (2) Exceptions shall be filed according to a schedule set by the reviewer, with a party filing exceptions having at least 7 days to file exceptions, and a party filing a response to exceptions having at least 5 days to file a response, unless this period is shortened by agreement of the parties. E. Final Decision. (1) The Commission shall issue a final decision based on the record of the proceeding including findings of fact and conclusions of law, that: (a) Finds the allegations to be substantiated and withdraws the MHCC-certified EHN status of the entity; (b) Finds the allegations to be substantiated, but permits the entity to retain MHCC-certified EHN status, with appropriate conditions; or (c) Finds the allegations to be unsubstantiated and continues the entity's MHCC-certified EHN status. (2) An MHCC-certified EHN aggrieved by the Commission's final decision may seek judicial review pursuant to State Government Article, Title 10, Annotated Code of Maryland. ### Chapter 08 — Evaluation of Quality and Performance of Health Benefit Plans **Authority:** Health-General Article, §§19-109(a)(1) and (7), 19-132, and 19-134(c), Annotated Code of Maryland **Administrative History:** Effective date: October 17, 2011 (38:21 Md. R. 1278) #### Regulation .01 Scope. *COMAR 10.25.08.01* A. This chapter applies to each carrier that participates in the health benefit plan quality and performance evaluation system. B. This chapter requires participation in the health benefit plan quality and performance evaluation system by each carrier that: (1) Holds a certificate of authority in the State; (2) Has a premium volume in Maryland for each category of health benefit plan that exceeds $1,000,000; and (3) Has no more than 65 percent of its Maryland enrollees covered through the Medicaid and Medicare Programs (for each category of health benefit plan), as reported in an annual statement submitted by a carrier to the Commission that includes premium volume and enrollment percentages for the calendar year preceding the reporting period. C. The evaluation system described in this chapter is designed to address the information needs of consumers and purchasers by providing an assessment of the quality and performance of health benefit plans based on measures endorsed or implemented by nationally recognized organizations involved in quality of care and performance measurement. #### Regulation .02 Definitions. *COMAR 10.25.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Carrier” means an insurer or nonprofit health service plan that holds a certificate of authority and provides health insurance policies or contracts in the State in accordance with Insurance Article, Annotated Code of Maryland, or a health maintenance organization that holds a certificate of authority in the State. (2) “Commission” means the Maryland Health Care Commission. (3) Health Benefit Plan. (a) “Health benefit plan” means a hospital or medical policy, contract, or certificate issued by a carrier. (b) “Health benefit plan” does not include: (i) Coverage for accident or disability income insurance; (ii) Coverage issued as a supplement to liability insurance; (iii) Liability insurance, including general liability insurance and automobile liability insurance; (iv) Workers’ compensation or similar insurance; (v) Automobile or property medical payment insurance; (vi) Credit-only insurance; (vii) Coverage for on–site medical clinics; (viii) Dental or vision insurance; (ix) Long-term care insurance or benefits for nursing home care, home health care, community-based care, or any combination of these; (x) Coverage only for a specified disease or illness; (xi) Hospital indemnity or other fixed indemnity insurance or a hospital or medical policy, contract, or certificate issued by a carrier; or (xii) If offered as a separate insurance policy, Medicare supplemental health insurance, as defined in §1882(g)(1) of the Social Security Act, coverage supplemental to the coverage provided under Chapter 55 of Title 10 of the United States Code, or similar supplemental coverage provided under an employer sponsored plan. (4) “HEDIS” means the Healthcare Effectiveness Data and Information Set published by the National Committee for Quality Assurance. (5) “Measurement year” means the calendar year in which services take place and that precedes the reporting period in which the quality and performance measures report is submitted to the Commission or its contractor. (6) “Performance measures report” means the report that a carrier submits to the Commission or its contractor that includes the performance measures calculated in accordance with the HEDIS and other applicable performance measure specifications. (7) “Proprietary information” means information that would put a carrier at a competitive disadvantage if such information were disclosed. (8) “Quality and performance evaluation system” means the process by which the Commission carries out its responsibilities related to the evaluation and reporting of quality and performance of health benefit plans. (9) “Reporting period” means the year in which a carrier submits HEDIS and other performance measures to the Commission or its contractor and which follows the measurement year. #### Regulation .03 Health Benefit Plan Quality and Performance Evaluation System — Implementation. *COMAR 10.25.08.03* A. Carrier Participation. (1) Each carrier may participate in the health benefit plan quality and performance evaluation system. (2) Each carrier that meets the criteria of Regulation .01B of this chapter is required to participate. (3) A carrier that chooses not to participate in the health benefit plan quality and performance evaluation system must present clear evidence to the Commission that shows that the carrier has no more than $1,000,000 in annual premium volume by category of health benefit plan and no more than 65 percent of its Maryland enrollees covered through the Medicaid and Medicare programs. B. Performance Measures. The Commission shall choose performance measures that are important, feasible, scientifically sound, and actionable, including performance measures that: (1) Are related to the quality and performance of medical services provided by a health benefit plan; (2) Allow for comparisons among health benefit plans; (3) Can be of interest to purchasers, consumers, providers, carriers, or health officials; (4) Can be used to affect changes in performance; and (5) Can be validated through an audit conducted by an independent party for validity, reliability, and comparability. C. Notice by the Commission. (1) Beginning in November 2011, and each November thereafter, the Commission shall provide a dated notice posted on the Commission’s website and a written notice to each carrier required to report under Regulation .01A. of this chapter regarding the following: (a) The required categories of health benefit plans for which HEDIS and other performance measures must be submitted for the upcoming measurement year; (b) The selected HEDIS and other performance measures for each category of health benefit plan to be included in the reporting period; and (c) Quality and performance measures that will be subject to audit. (2) Beginning in December 2011, and each December thereafter, the Commission shall provide a dated notice posted on the Commission’s website and a written notice to each carrier required to report under Regulation .01A of this chapter regarding the following: (a) The required categories of health benefit plans for which HEDIS and other performance measures must be submitted for the upcoming measurement year; (b) The selected HEDIS and other performance measures for each category of health benefit plan to be included in the reporting period; (c) Quality and performance measures that will be subject to audit; and (d) The HEDIS and other performance measures anticipated to be required in the measurement year occurring after the current measurement year. D. Performance Measures Collection. (1) Beginning in January of each reporting period, a carrier that is required to participate or elects to participate in the health benefit plan quality and performance evaluation system shall collect all required performance measures as follows: (a) Collecting HEDIS measures, a carrier shall follow the specifications contained in the latest version or technical update of HEDIS applicable to the measurement year; (b) Collecting other performance measures, a carrier shall follow specifications published by a nationally recognized organization involved in quality and performance measurement, and in accordance with the notice provided by the Commission in November for the measurement year; and (c) A carrier shall use the specifications, templates, and other documents provided by the Commission, which shall be consistent with those published by the National Committee for Quality Assurance for HEDIS measures and, for non-HEDIS performance measures, required by the Commission, consistent with specifications, templates, or documents published by nationally recognized organizations involved in quality of care and performance measurement. (2) A carrier is not required to submit HEDIS or other performance measures regarding proprietary information contained in descriptive information on health plan management and activities. (3) The Commission shall provide technical assistance and auditing services to a carrier required to report the HEDIS and other performance measures. E. Commission Publication of Health Benefit Plan Quality and Performance Evaluation Reports. On or before November 1 of each year, the Commission shall publish on its website one or more reports for use by consumers and purchasers who make health benefit plan enrollment and contracting decisions. The reports shall: (1) Compare quality and performance evaluation results of each health benefit plan on the various HEDIS and other performance measures required by the Commission; and (2) Include information on valid and reliable HEDIS and other performance measures that are comparable on a health benefit plan level, as determined by the Commission. #### Regulation .04 Audits. *COMAR 10.25.08.04* A. In order to verify the validity, reliability, and comparability of HEDIS and other performance measures required by the Commission, a carrier shall participate in certified audits as specified by the Commission, which may include: (1) A process audit; (2) One or more site visits; (3) Specification and source code review and verification; and (4) Medical records review. B. Each carrier that is required to participate or elects to participate in the health benefit plan quality and performance evaluation system shall submit audited HEDIS and other performance measures for each designated health benefit plan for the reporting period to the Commission or its contractor by June 1 of the reporting period. C. Within the time period specified by the Commission, a carrier shall correct inaccurate or incomplete data contained in its performance measures report that become apparent during the audit or other process. #### Regulation .05 Extension of Time. *COMAR 10.25.08.05* A. A carrier may request an extension of not more than 30 days for submission of the performance measures report. B. A request for an extension of time shall: (1) Be submitted to the Executive Director of the Commission not later than 30 days before the carrier’s performance measures report is due; (2) Explain the good cause for the requested extension; and (3) Propose a reasonable date certain, not to exceed 30 days after the original due date, for submission of the performance measures report. C. A carrier may seek Commission review of the Executive Director’s denial of a requested extension of time by filing a written petition for review within 7 days of receipt of the denial. D. The Commission shall provide the carrier with an opportunity to present its position to the Commission, and may affirm, reverse, or modify the decision of the Executive Director. #### Regulation .06 Penalty for Failure to File Reports. *COMAR 10.25.08.06* A carrier that is required to participate under Regulation .01B of this chapter and that does not timely file a performance measures report may be subject to the penalties provided in COMAR 10.25.12. ### Chapter 09 — Requirements for Payers to Designate Electronic Health Networks **Authority:** Health-General Article, §§4-302.1, 19-101, 19-103(c)(9) and (10), 19-109(a)(1), and 19-134(a) and (b), Annotated Code of Maryland **Administrative History:** Effective date: July 15, 1996 (23:14 Md. R. 1009) **Administrative History:** Regulation .02 amended effective July 23, 2001 (28:14 Md. R. 1322) **Administrative History:** Regulation .03 amended as an emergency provision effective May 1, 1997 (24:11 Md. R. 792); emergency status expired October 1, 1997; amended permanently effective October 20, 1997 (24:21 Md. R. 1450) **Administrative History:** Regulation .03 amended effective July 23, 2001 (28:14 Md. R. 1322) **Administrative History:** Regulation .05A amended effective July 23, 2001 (28:14 Md. R. 1322) **Administrative History:** Chapter revised effective July 5, 2004 (31:13 Md. R. 994) #### Regulation .01 Scope. *COMAR 10.25.09.01* A. This chapter applies to a third-party payer operating in the State of Maryland, as of July 1, 1997, whose premium volume exceeds $1,000,000 as reported in the most recent annual statement in the hands of the Maryland Insurance Administration as of December 1 of each calendar year. B. At the discretion of the Maryland Health Care Commission, this chapter may also apply to third party payers operating in the State of Maryland whose premium volume is $1,000,000 or less. #### Regulation .02 Definitions. *COMAR 10.25.09.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adjudication” means paid, resolved, or settled. (2) “Commission” or “MHCC” means the Maryland Health Care Commission. (3) “HIPAA” means the Health Insurance Portability and Accountability Act of 1996, P.L. No. 104 — 191, 42 U.S.C. Title XI, Part C. (4) “Deputy Director” means the Deputy Director for Data Systems and Analysis at the Maryland Health Care Commission, or the Deputy Director's designee. (5) “Designate” means to select and to enter into a written agreement with. (6) “Designated EHNs” means MHCC-certified EHNs that have been selected by a payer to submit electronic health care transactions under a written service agreement with the payer on behalf of health care practitioners. (7) Electronic health care transactions" means health care transactions that are defined under HIPAA Transaction and Code Set Standards. (8) “Electronic health network (EHN)” means an entity that processes or facilitates processing of electronic transactions in standard or nonstandard formats, between two or more trading partners in the health care community. (9) “MHCC-certified electronic health network” means an entity that has received certifications from the Maryland Health Care Commission. (10) “Health insurance claim” means a submission of a claim to a third-party payer for payment for services rendered by a health care practitioner in Maryland. (11) “Third-party payer” or “payer” means a person that administers or provides reimbursement for health care benefits on an expense-incurred basis, including a: (a) Health maintenance organization issued a certificate of authority in accordance with Health-General Article, Title 19, Subtitle 7, Annotated Code of Maryland; (b) Health insurer or nonprofit health service plan authorized to offer health insurance policies or contracts in this State in accordance with Insurance Article, Title 14, Annotated Code of Maryland; (c) Third-party administrator registered under Insurance Article, Title 14, Annotated Code of Maryland; (d) Specialty payers, such as Pharmacy Benefit Managers (PBMs); or (e) Managed Care Organizations (MCOs) which contract with Maryland Medicaid to provide health services to Medicaid enrollees. #### Regulation .03 EHN Designation. *COMAR 10.25.09.03* A. Payers shall only contract with MHCC-certified EHNs for the exchange of electronic health care transactions that originate in Maryland. B. In the event that a designated EHN loses its MHCC-certified status, the Commission shall provide written notice to the payer of the event. C. Within 60 days from the date of the notice, the payer shall notify the Commission that it is no longer using that EHN for the exchange of electronic health care transactions. #### Regulation .04 Designation Requirements. *COMAR 10.25.09.04* The payer and its designated EHNs shall enter into a written agreement that shall address at minimum each of the following: A. Transaction format specifications; B. Transmission methods to be used; C. Schedules of events, such as transmission cutoffs, acknowledgment requirements, reporting requirements, and scheduled outages, etc; D. Editing requirements and schedules for changes or enhancements; E. Charges and terms of payment; and F. System access security requirements. #### Regulation .05 EDI Progress Report. *COMAR 10.25.09.05* A. On or before June 30 of each year, each payer shall submit to the Commission an EDI Progress Report Form, describing certain electronic health care transaction activity for the payer's previous calendar year as described in this regulation. B. This report shall include: (1) A certification of compliance with Health-General Article, §4-302.1, Annotated Code of Maryland; (2) Health care transactions as defined by HIPAA Transaction and Code Set Standards that are submitted or received by Maryland health care providers; (3) Electronic transaction activity between January 1 and December 31 of the previous year; and (4) The total number of HIPAA electronic transactions submitted or received by Maryland health care providers, as defined in the EDI Progress Report Form. #### Regulation .06 Waiver or Exception Request. *COMAR 10.25.09.06* A. A payer may submit a written request for waiver or exception of the reporting requirements. B. The payer shall: (1) Submit a written request for a waiver or exception to the Deputy Director not later than 30 days before the due date of meeting the reporting/designation requirements; and (2) Explain the reason for the waiver request. C. The Deputy Director shall grant a reasonable request for good cause shown. D. A payer may file a written petition for review of a denial of a waiver. E. The Commission shall review the decision of the Deputy Director. F. The Commission may affirm, reverse, or modify the decision of the Deputy Director after providing the payer with an opportunity to present its position to the Commission. #### Regulation .07 Extension of Time. *COMAR 10.25.09.07* A. A payer may request an extension of time of up to 60 days for submission of the EDI information. B. The payer shall: (1) Submit the request in writing to the Deputy Director for Data Systems and Analysis not later than 30 days before the reporting deadline; (2) Explain the reason for the extension request; and (3) Propose a reasonable date for submission. C. A payer may file a written petition for review of a denial of an extension of time. D. The Commission shall review the decision of the Deputy Director. E. After providing the payer with an opportunity to present its position to the Commission, the Commission may affirm, reverse, or modify the decision of the Deputy Director. #### Regulation .08 Penalties for Failure to File a Report. *COMAR 10.25.09.08* A. Unless the Deputy Director has granted an extension of time, a payer that does not timely file a report is liable for a monetary penalty of $1,000 per day for each day the filing of the report is delayed. B. A report that is substantially incomplete or inaccurate is not timely filed. C. The filing of a written petition for review of a denial of an extension of time stays the accrual of the monetary penalty under §A of these regulations. D. If the Commission affirms the action of the Deputy Director to deny a payer's request for an extension of time, the Commission may impose all penalties in full or in part which, absent the stay, would have accrued during the pendency of the review. E. For substantial reasons shown, the Commission may suspend, reduce, or waive any penalty imposed under this chapter. #### Regulation .09 Penalties for Failure to Contract with a MHCC-Certified EHN. *COMAR 10.25.09.09* A. Unless the Deputy Director has granted an extension of time, a payer that does not contract with an MHCC-Certified EHN within 60 days of notification by MHCC that the EHN is not certified, is liable for a monetary penalty of $1,000 per day. B. The filing of a written petition for an extension of time stays the accrual of the monetary penalty under §A of this regulation. C. If the Commission affirms the action of the Deputy Director to deny a payer's request for an extension of time, the Commission may impose all penalties in full or in part which, absent the stay, would have accrued during the pendency of the review. D. For substantial reasons shown, the Commission may suspend, reduce, or waive any penalty imposed under this chapter. ### Chapter 10 — Maryland Trauma Physician Services Fund **Authority:** Health-General Article, §§19-103(c), 19-130, and 19-207, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .16 adopted as an emergency provision effective July 1, 2003 (30:19 Md. R. 1327); adopted permanently effective December 22, 2003 (30:25 Md. R. 1846) **Administrative History:** Regulations .01 — .16 repealed and new regulations .01 — .17 adopted as an emergency provision effective July 1, 2006 (33:21 Md. R. 1672); adopted permanently effective October 23, 2006 (33:21 Md. R. 1676) **Administrative History:** Regulations .01 — .17 repealed and new regulations .01—.19 adopted effective June 15, 2009 (36:12 Md. R. 837) **Administrative History:** Regulation .01 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .02B amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .03B amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .04 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .05 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .06 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .07 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .08 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .09 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .10 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .11B, C amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .12 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .13 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .14A, C amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .15 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .16B amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .17 amended effective January 20, 2025 (52:1 Md. R. 18) **Administrative History:** Regulation .19 amended effective January 20, 2025 (52:1 Md. R. 18) #### Regulation .01 Scope. *COMAR 10.25.10.01* A. This chapter applies to trauma physicians, trauma health care practitioners, and Maryland Institute for Emergency Medical Services Systems designated trauma centers, Specialty Referral Centers, and rehabilitation hospitals that are affiliated with Maryland Institute for Emergency Medical Services Systems designated trauma centers by common ownership, as defined in Health-General Article, §19-130(a)(3) and (4), Annotated Code of Maryland, that provide trauma care. B. Reimbursement. (1) Trauma physicians or trauma health care practitioners seeking reimbursement for uncompensated care provided to trauma patients shall file a claim pursuant to this chapter to receive reimbursement from the Maryland Trauma Physician Services Fund. (2) Trauma physicians or trauma health care practitioners seeking reimbursement for trauma care provided to trauma patients enrolled in the Maryland Medical Assistance Program at the elevated rate shall comply with special billing requirements pursuant to this chapter. (3) Trauma centers seeking reimbursement for costs of maintaining trauma physicians on-call shall file a claim to receive reimbursement from this Fund. (4) Trauma centers seeking reimbursement for standby costs shall file a claim to receive reimbursement from this Fund. (5) Trauma centers seeking trauma grants shall file an application to receive a grant from this Fund in accordance with a process and guidelines developed by the Maryland Health Care Commission. #### Regulation .02 Definitions. *COMAR 10.25.10.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means a person or entity eligible to file a claim to receive reimbursement from the Fund. (2) “Commission” means the Maryland Health Care Commission. (3) “Faculty practice plan” means a professional services organization that: (a) Includes physicians; and (b) Is formed to carry out, improve, and supplement the medical education, research, and clinical services program of a medical school. (4) “Fraud” means knowingly and willfully making or causing to be made any false statement or representation of a material fact: (a) In a claim for payment; or (b) In determining eligibility for payments. (5) “Fund” means the Maryland Trauma Physician Services Fund. (6) “HSCRC” means the Health Services Cost Review Commission. (7) “Maryland Trauma Registry” means a clinical trauma registry maintained by MIEMSS that: (a) Monitors and provides information necessary to evaluate major trauma or specialty patient care, outcome, and cost; and (b) Assesses how designated trauma centers and other hospitals comply with the trauma standards, regulations, and protocols. (8) Medicaid. (a) “Medicaid” means the Maryland Medical Assistance Program under Title XIX of the Social Security Act, 42 U.S.C. §1396, et seq. and the Children and Families Health Care Program under Title XXI of §4901 of the Balanced Budget Act of 1997, that provide comprehensive medical and other health-related care for indigent and medically indigent persons. (b) “Medicaid” includes the services provided by a managed care organization under the State waiver program authorized under §1115 of the Social Security Act, 42 U.S.C. §1396n. (9) “Medicaid differential” means the difference in reimbursement between Medicare and Medicaid for trauma services provided by a trauma physician or trauma health care practitioner to a Medicaid trauma patient in a trauma center. (10) “Medicare economic index (MEI)” means the federal Centers for Medicare and Medicaid Services' measure of inflation in the inputs for providing physician services. (11) “MIEMSS” means the Maryland Institute for Emergency Medical Services Systems. (12) On-Call Physician. (a) “On-call physician” means a trauma physician who commits for a specific time period to be available and respond within a certain amount of time, as defined by MIEMSS, to provide care for a trauma patient in the trauma center. (b) “On-call physician” does not include a physician on standby in a trauma center. (13) On-Call Costs. (a) “On-call costs” means the costs to a trauma center to have trauma physicians available and ready to respond to trauma patients within a certain amount of time, as defined by MIEMSS. (b) “On-call costs” does not include standby costs. (14) “On-call services application” means the difference in reimbursement between Medicare and Medicaid for trauma services provided by a trauma physician or trauma health care practitioner to a Medicaid trauma patient in a trauma center. (15) “Reasonable compensation equivalent (RCE)”: (a) Is a methodology established by Medicare to set limits on what a hospital may claim per physician specialty standby hour; and (b) Has the meaning described in 68 FR 45458 (Aug. 1, 2003). (16) Service Period. (a) “Service period” means the time that trauma services are provided from entrance to the trauma center until dismissal or discharge from the trauma center. (b) “Service period” includes a subsequent readmission or outpatient visit to the trauma center, or trauma center-affiliated acute care general hospital, for services that are directly related to the initial trauma injury. (c) “Service period” includes a subsequent admission or outpatient visit to a trauma center-affiliated rehabilitation hospital, or rehabilitation unit of a trauma center. (17) “Specialty referral center” means: (a) The Curtis National Hand Center at Union Memorial Hospital; (b) The Eye Trauma Center at the Wilmer Eye Institute at The Johns Hopkins Hospital; and (c) The Johns Hopkins Health System Burn Program. (18) “Standby costs” means costs to a trauma center for paying physicians to be available on site at the trauma center to treat trauma patients. (19) Trauma Center. (a) “Trauma center” means a hospital designated by the Maryland Institute for Emergency Medical Services Systems (MIEMSS) as: (i) The State primary adult resource center; (ii) A Level I trauma center; (iii) A Level II trauma center; (iv) A Level III trauma center; (v) A pediatric trauma center; or (vi) A specialty referral center as defined in §B(17) of this regulation. (b) “Trauma center” includes a pediatric trauma center that has entered into an agreement with MIEMSS. (20) “Trauma health care practitioner” means a health care practitioner licensed under the Health Occupations Article who provides care in a trauma center-affiliated general acute care hospital or in a trauma center-affiliated rehabilitation hospital during the service period to trauma patients on the Maryland Trauma Registry as defined by the Maryland Institute for Emergency Medical Services Systems (MIEMSS). (21) “Trauma patient” means a patient whose trauma services are documented in the Maryland Trauma Registry. (22) “Trauma physician” means a physician who provides care in a trauma center, trauma center-affiliated general acute care hospital, or in a trauma center-affiliated rehabilitation hospital during the service period to a trauma patient on the Maryland Trauma Registry as defined by the Maryland Institute for Emergency Medical Services Systems (MIEMSS). (23) “Trauma services” means trauma care provided to a trauma patient in a trauma center, trauma center-affiliated general acute care hospital, trauma center-affiliated rehabilitation hospital, or rehabilitation unit of a trauma center. (24) “Uncompensated care” means trauma services provided by a trauma physician or trauma health care practitioner to a trauma patient on the Maryland Trauma Registry who: (a) Has no health insurance, including private health insurance, Medicare Part B coverage, VA health benefits, or CHAMPUS; (b) Is not covered by Workers' Compensation coverage; (c) Is not eligible for Medical Assistance coverage; and (d) Has not paid the full Medicare reimbursement for the trauma care received, even after documented attempts by the trauma physician or trauma health care practitioner to obtain payment. (25) “Uncompensated care shortfall” means the difference in reimbursement between what Medicare pays and what the trauma physician providing care collects from the uncompensated care trauma patient. (26) “Uncompensated services claim” means a CMS 1500 form or an ANSI 837 electronic transaction completed according to Commission specifications and submitted for reimbursement of uncompensated care services. #### Regulation .03 Fund Administration. *COMAR 10.25.10.03* A. The Fund is a special, nonlapsing interest bearing fund that is not subject to State Finance and Procurement Article, §7-302, Annotated Code of Maryland. B. The purpose of the Fund is to subsidize the documented costs: (1) Of uncompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma services to a trauma patient on the Maryland Trauma Registry; (2) Of undercompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma services to an enrollee of the Medicaid Program who is a trauma patient on the Maryland Trauma Registry; (3) Incurred by a trauma center to maintain trauma physicians on-call as required by MIEMSS; (4) Incurred by a trauma center to maintain patient education, equipment, services, systems, and training as required by MIEMSS, for trauma-related care and not otherwise reimbursed; and (5) Incurred by the Commission to administer the Fund and audit reimbursement requests and trauma grants to assure appropriate payments are made from the Fund. C. Administering Agencies. The Commission shall administer the disbursements from the Fund. D. Interest. The interest on the Fund shall be accounted for separately and credited to the Fund, and is not subject to State Finance and Procurement Article, §6-226(a), Annotated Code of Maryland. #### Regulation .04 Source of Fund Revenue. *COMAR 10.25.10.04* A. The Fund consists of motor vehicle registration surcharges paid into the Fund in accordance with Transportation Article, §§13-954(b), and 21-902, Annotated Code of Maryland, and regulations promulgated under that authority, and any other money transferred from the General Fund of the State. B. The Commission shall make reimbursement from the Fund for: (1) On-call costs; (2) Uncompensated care costs; (3) Medicaid differential payments; (4) Standby expenses to an out-of-State pediatric trauma center that has entered into an agreement with the Maryland Institute for Emergency Medical Services Systems; (5) Grants that may cover costs of trauma centers for trauma related expenses, including physician standby, patient education, equipment, services, systems, training, and other MIEMSS-required incremental trauma costs not otherwise reimbursed; and (6) The Commission's administrative expenses including: (a) The adjudication of uncompensated trauma claims; (b) The audit of providers receiving uncompensated care trauma payments, Medicaid trauma payments, and on-call payments; (c) The audit of managed care organizations payments to trauma physicians and trauma health care practitioners; (d) Enhancements of the MIEMSS Trauma Registry; and (e) Commission personnel costs associated with administering the Fund. #### Regulation .05 Who May Request Payment. *COMAR 10.25.10.05* A. A trauma physician or trauma health care practitioner as defined in Regulation .02 of this chapter may request payment under this chapter. B. Medicaid and Uncompensated Care Reimbursement. (1) Trauma Practitioner Services. A faculty practice plan, a physician practice, a trauma center on behalf of the trauma physician or trauma health care practitioner, or an individual trauma physician or individual health care practitioner allowed to bill Medicaid may submit requests for payment for trauma services provided to a Medicaid trauma patient or for uncompensated care trauma services if: (a) Those services are provided to a trauma patient during the service period as defined in this chapter; and (b) The practitioner meets the definition of a trauma physician or trauma health care practitioner under Regulation .02 of this chapter. (2) Emergency Physician Services. (a) The total reimbursement from the Fund to emergency physicians practicing at any one trauma center may not exceed $300,000 annually. (b) An emergency room physician: (i) Is eligible for uncompensated care shortfall payments only; and (ii) May not receive Medicaid differential payments or on-call payments from the Fund. C. On-Call Payments. The following trauma centers may apply for on-call payments: (1) A MIEMSS-designated Level I trauma center or pediatric trauma center; (2) Level II and Level III trauma centers; and (3) The Specialty Referral Centers. D. Standby Payments. An out-of-State pediatric trauma center that has entered into an agreement with MIEMSS may apply for an annual grant to subsidize standby costs. #### Regulation .06 Payments for Medicaid Trauma Patients. *COMAR 10.25.10.06* A. A trauma physician or trauma health care practitioner: (1) Is eligible for payment from the Fund for trauma services provided to a Medicaid trauma patient on the Maryland Trauma Registry on or after July 1, 2024; and (2) May seek reimbursement in accordance with this regulation. B. A trauma physician or trauma health care practitioner providing trauma services to a Medicaid trauma patient during the service period shall be reimbursed at the greater of: (1) The Medicaid routine payment rate; or (2) Up to 100 percent of the current Medicare facility-based payment in the Baltimore carrier locality area. C. To be eligible for the Medicaid differential payment described in §B of this regulation, diagnosis codes shall meet one of the following two conditions: (1) A diagnosis code shall fall between 800.00 — 959.9; or (2) If a diagnosis code does not fall between 800.0 — 959.9, a supplementary classification of external causes of injury and poisoning (E800 — E999) shall appear as a secondary diagnosis code. D. An organization billing on behalf of trauma physicians or trauma health care practitioners eligible for Medicaid differential payments shall designate a trauma service by using the appropriate code in the CPT Modifier field on the electronic claim or on the paper CMS 1500 in accordance with Medicaid claims submission requirements. E. To be eligible for the Medicaid differential payment described in §B of this regulation, the place of service code shall have one of the following values: (1) Appropriate code to indicate “acute care inpatient hospital”; (2) Appropriate code to indicate “outpatient hospital”; (3) Appropriate code to indicate “emergency room”; or (4) Appropriate code to indicate “inpatient rehabilitation hospital”. F. The Maryland Department of Health may apply Medicaid payment rules when adjudicating claims for trauma services to trauma patients. G. The Fund shall transfer to the Maryland Department of Health an amount sufficient to fully cover the State's share of expenditures for Medicaid differential payments for that fiscal year. #### Regulation .07 Payments for Uncompensated Care Patients. *COMAR 10.25.10.07* A. A trauma physician or trauma health care practitioner: (1) Is eligible for payment from the Fund for trauma services provided to uncompensated trauma care patients with an admission date on the Maryland Trauma Registry beginning on or after July 1, 2024; and (2) May seek reimbursement in accordance with this regulation. B. The cost of uncompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma care to a trauma patient as defined in this chapter shall be reimbursed at a rate of up to 100 percent of the current Medicare facility-based payment for a service in the Baltimore carrier locality area, less any amount for trauma physician or trauma health care practitioner services paid by the patient or other third-party payors including, but not limited to, auto insurance, criminal injuries compensation fund, attorneys, or collection agencies, as reported to the Fund on the uncompensated services claim. C. An organization billing on behalf of trauma physicians or trauma health care practitioners eligible for uncompensated care payments shall: (1) Designate a trauma service by appropriate coding of the CPT Modifier on the electronic ANSI 837 transaction or paper CMS 1500 claim in accordance with claims submission requirements; and (2) Include the patient's trauma registry number on the electronic claim or on the CMS 1500. D. Diagnosis Code. (1) Except as provided in §D(2) of this regulation, a diagnosis code shall fall between 800.00 — 959.9. (2) If a diagnosis code does not fall between 800.0 — 959.9, a supplementary classification of external causes of injury and poisoning (E800 — E999) shall appear as a secondary diagnosis code. E. To be eligible for uncompensated care differential payment described in §B of this regulation, the place of service code shall have one of the following values: (1) Appropriate code for “acute care inpatient hospital”; (2) Appropriate code for “outpatient hospital”; (3) Appropriate code for “emergency room”; or (4) Appropriate code for “rehabilitation hospital”. F. The uncompensated services claim shall: (1) Document uncompensated care services not previously claimed under the Fund; (2) Exclude services for trauma patients who have applied for assistance through Medicaid, but who have not received a final eligibility determination; (3) Exclude noncovered services that the trauma physician or trauma health care practitioner provided to trauma patients covered by health insurance; (4) Exclude services for trauma patients covered by health insurance for which the trauma physician or trauma health care practitioner failed to comply with the insurer's coverage rules or claim filing requirements; and (5) Have a date of service on the claim not older than 5 years. G. Uncompensated care services are eligible for reimbursement from the Fund only after a faculty practice plan, a physician practice, a trauma center on behalf of a trauma physician or trauma health care practitioner, an individual trauma physician or an individual trauma health care practitioner has completed its collection efforts using the respective entity's documented policies and procedures. H. Order of Preference. (1) To minimize administrative costs in administering the Fund, the order of preference for the entity submitting an uncompensated services claim is as follows: (a) Faculty practice plan; (b) Physician practice; (c) Trauma physician; (d) Individual trauma health care practitioner. (2) The preference specified in §H(1) of this regulation refers to the submitting entity and not the preference for distributing payments. I. A trauma patient treated at an out-of-State pediatric trauma center that has entered into an agreement with MIEMSS shall be a Maryland resident in order for the trauma physician or trauma health care practitioner to file an uncompensated services application for an uncompensated care shortfall payment. The determination of whether a trauma patient is a Maryland resident shall be based on the trauma patient's demographic information as listed on the Maryland Trauma Registry. J. The uncompensated services claim shall contain the following information: (1) The name and federal tax identification number of the trauma physician or trauma health care practitioner rendering the care; (2) The date of the service; (3) Appropriate codes describing the service; (4) Any amount recovered for the service rendered; (5) The name of the trauma patient; (6) The trauma patient's Maryland Trauma Registry number; (7) Date of the original trauma injury; (8) The diagnosis codes that were treated; (9) The procedure and service codes performed; and (10) Other information requested in the claim. K. The Commission, in consultation with the Health Services Cost Review Commission, may establish a payment rate for uncompensated care incurred by a trauma physician or trauma health care practitioner in providing trauma care to trauma patients that is above the 100 percent of Medicare payment for the service if: (1) The Commission determines that increasing the payment rate above 100 percent of the Medicare payment for the service will address an unmet need in the State trauma system; (2) The source of revenue increases and the projected current uses of the Fund decline; (3) The Commission considers data analyses of trauma care rendered at Maryland trauma centers for CPT codes reimbursed as uncompensated care as reported to the Maryland Medical Care Data Base; and (4) The Commission reports on its intention to increase the payment rate to the Senate Finance Committee and the House Health and Government Operations Committee, at least 60 days before any adjustment to the rate. #### Regulation .08 On-Call Payment. *COMAR 10.25.10.08* A. Eligibility. The Fund will reimburse trauma centers' on-call costs to maintain surgeons on-call in conformance with MIEMSS' regulations at COMAR 30.08.05 — 30.08.14 for the minimum number of trauma physicians required to be on-call. Trauma centers are eligible for on-call payments as follows: (1) The Level I trauma center and pediatric trauma center are eligible for on-call payments for on-call hours provided by trauma specialties designated in §B of this regulation on or after July 1, 2024; (2) Level II trauma centers are eligible for on-call payments for on-call hours provided by trauma specialties designated in §C of this regulation; (3) Level III trauma centers are eligible for on-call payments for on-call hours provided by trauma specialties designated in §D of this regulation; and (4) Specialty Referral Centers are eligible for on-call payments for on-call hours provided by trauma specialties designated in §E of this regulation on or after July 1, 2024. B. To determine the amount of on-call payments to a Level I trauma center or pediatric trauma center from the Fund, the following apply: (1) The cost incurred by a Level I trauma center or pediatric trauma center to maintain trauma surgeons, pediatric trauma surgeons, neurosurgeons, and orthopedic surgeons on-call when a post-graduate resident, who meets MIEMMS’ requirements under COMAR 30.08.05.07, is attending shall be reimbursed at the lesser of a trauma center's actual on-call costs, or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; (2) A Level I trauma center shall be eligible for a maximum 4,380 on-call hours each fiscal year beginning July 1, 2024; and (3) A pediatric trauma center shall be eligible for a maximum 4,380 on-call hours each fiscal year beginning July 1, 2024. C. To determine the amount of on-call payments to a Level II trauma center from the Fund, the following apply: (1) The cost incurred by a Level II trauma center to maintain trauma surgeons, neurosurgeons, and orthopedic surgeons on-call shall be reimbursed at the lesser of a trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; and (2) A Level II trauma center shall be eligible for a maximum 26,280 on-call hours each fiscal year beginning July 1, 2024. D. To determine the amount of on-call payments to a Level III trauma center from the Fund, the following apply: (1) The cost incurred by a Level III trauma center to maintain anesthesiologists, neurosurgeons, orthopedic surgeons, and trauma surgeons on-call shall be reimbursed at the lesser of a trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalents hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; (2) A Level III trauma center shall be eligible for a maximum 35,040 on-call hours each fiscal year beginning July 1, 2024. E. To determine the amount of on-call payments to a Specialty Referral Center from the Fund, the following apply: (1) The cost incurred by a Specialty Referral Center to maintain trauma surgeons on-call for the Johns Hopkins Health System Burn Program shall be reimbursed at the lesser of the trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; (2) The cost incurred by a Specialty Referral Center to maintain trauma surgeons on-call for the Eye Trauma Center at the Wilmer Eye Institute at The Johns Hopkins Hospital, the cost incurred to maintain ophthalmologists on-call shall be reimbursed at the lesser of the trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; (3) The cost incurred by a Specialty Referral Center to maintain trauma surgeons on-call for the Curtis National Hand Center at Union Memorial Hospital, shall be reimbursed at the lesser of the trauma center's actual on-call costs or up to 60 percent of the reasonable compensation equivalent's hourly rate for the specialty, inflated to the current year by the physician compensation component of the Medicare Economic Index as designated by the Centers for Medicare and Medicaid Services; and (4) A Specialty Referral Center trauma center shall be eligible for a maximum 2,190 hours of trauma on-call per fiscal year, beginning July 1, 2024. F. The trauma center shall apply for payment from the Fund by submitting a semiannual on-call services application within 30 days after the end of the reporting cycle. G. The on-call services application shall list on-call costs paid to trauma physicians at the trauma center during the reporting cycle. The on-call services application shall contain the following information: (1) The name and trauma level of the trauma center; (2) The name of each trauma physician providing on-call coverage; (3) The specialty of each trauma physician providing on-call coverage; (4) The amount of time available on-call for each physician; (5) The amount paid in on-call stipends to each physician; and (6) Any other information required by the Commission to validate the claim. H. The Commission may increase the hours and percent of RCE specified in this regulation in accordance with Health General § 19-130, Annotated Code of Maryland. #### Regulation .09 Payment for Costs at a Pediatric Center. *COMAR 10.25.10.09* A. The pediatric trauma centers listed below shall be eligible for an annual grant of up to $900,000 for documented expenses related to the provision of trauma care to Maryland residents: (1) Johns Hopkins Children’s Center; and (2) Children’s National Medical Center. B. Pediatric trauma centers shall submit an application for documented expenses incurred in the previous fiscal year using guidelines developed by the Health Services Cost Review Commission. C. The pediatric trauma center shall submit the application for its previous fiscal year to the Commission within 45 days after the end of that fiscal year. #### Regulation .10 Trauma Equipment Grants. *COMAR 10.25.10.10* A. Eligibility. (1) The Commission, in consultation with the Health Services Cost Review Commission and the Maryland Institute for Emergency Medical Services Systems, shall develop a process for the award of grants to Level I, Level II and Level III trauma centers to be used in the delivery of trauma care. (2) The process developed by the Commission for the award of grants shall include: (a) Grant applications and review and selection criteria for the award of grants; (b) Review by the Commission, if necessary, for any project that exceeds Certificate of Need thresholds; and (c) Any other procedure determined necessary by the Commission. B. The Commission may issue grants from any balance carried over to the Fund from prior fiscal years. C. The total amount of grants awarded in a fiscal year may not reduce the balance remaining in the Fund at the end of the fiscal year to less than 15 percent of the revenue collected in that fiscal year. D. Before awarding grants under this regulation in a fiscal year, the Commission shall report to the Senate Finance Committee and the House Health and Government Operations Committee on the process that the Commission has developed for awarding grants in that fiscal year. #### Regulation .11 Equitable Payment Under the Fund. *COMAR 10.25.10.11* A. Disbursement from the Fund is subject to the availability of funds. B. The Commission shall adjust reimbursement formulas used for Medicaid trauma services, uncompensated care trauma services, on-call payments, and standby payments to a pediatric trauma center to preserve the distribution of monies in the Fund. C. Revenue; Payments. (1) On or before May 1 of each year, the Commission shall determine appropriate levels of payment that can be sustained for the upcoming fiscal year beginning July 1, given the expected revenue in the Fund. (2) If expected revenue in the Fund is insufficient to meet expected payments, the Medicaid differential payments, uncompensated care shortfall payments, trauma center on-call payments, and standby payments to a pediatric trauma center shall be adjusted by the same rate to maintain solvency in the Fund. (3) The Commission shall maintain a sufficient balance in the Fund to assure equitable payments across a fiscal year. (4) If Fund payments require adjustment, the Commission shall report to the trauma centers and the trauma physicians listed on trauma center rosters the expected payment levels for the upcoming State fiscal year by June 30. D. If the Commission estimates that operating shortfalls will occur during a fiscal year and that those shortfalls will be sufficiently large that the annual update process cannot be used, the Commission shall use the following conventions: (1) On-call payments for the next semiannual reporting period shall be adjusted to preserve solvency in the Fund; (2) Priority for meeting the funding needs of Level III trauma centers to maintain physicians shall be maintained; (3) The Commission may not change Medicaid reimbursement during a fiscal year, unless a 4-month notice is provided to the Medicaid program and the uncompensated care and on-call payments have already been halted; and (4) The Commission shall adjust Medicaid reimbursements during subsequent annual update processes to adjust for any inequities that arise due to implementation of §D(3) of this regulation during the preceding fiscal year. #### Regulation .12 Filing of On-call Applications and Uncompensated Care Claims. *COMAR 10.25.10.12* A. In order to receive a payment from the Fund for uncompensated care, a faculty practice plan, a physician practice, a trauma physician, a trauma health care practitioner, or a trauma center on behalf of a trauma physician or trauma health care practitioner shall submit a timely and complete uncompensated services claim that includes the information required in this chapter on a form and in a manner approved by the Commission as indicated in the application. B. In order to receive a payment from the Fund for on-call costs, a faculty practice plan, a physician practice, a trauma physician, or a trauma center on behalf of a trauma physician, shall submit a timely and complete on-call services application that includes the information required in this chapter on a form and in a manner approved by the Commission as indicated in the application. C. A faculty practice plan, a physician practice plan, a trauma center, or a trauma physician that does not file an on-call services application within the time frame specified is not eligible for participation in the Fund for that time period. D. An on-call services application that is substantially incomplete or inaccurate may be considered not filed. #### Regulation .13 Audits. *COMAR 10.25.10.13* A. The Commission, or its designee, may audit to verify the information submitted by faculty practice plans, physician practices, trauma physicians, trauma health care practitioners, and trauma centers applying for grants or reimbursement from the Fund. B. The Commission, or its designee, may perform on-site audits. C. A person who has submitted an application for a grant or reimbursement from the Fund shall provide the Commission, or its designee, with access to all information, documents, and facilities requested by the Commission, or its designee, for purposes of auditing the person’s application. D. Information discovered by the audit process indicating that an application for payment from the Fund was improperly paid may result in remedial action being taken, including but not limited to, denial or partial denial of future payments from the Fund, referral to the State of Maryland, Central Collections Unit, or other appropriate action. #### Regulation .14 Appeals. *COMAR 10.25.10.14* A. The Commission's executive director, or designee, shall review any appeal from an audit finding, a denial, or partial denial, of an uncompensated care shortfall payment, an on-call payment or grant award. B. To secure review of an audit finding, denial, or partial denial, an applicant shall file a written appeal of the denial with the Commission, together with any supporting memoranda and documentation, within 15 days of the date of receipt of audit finding, the denial, or the partial denial, from the Fund. C. In reviewing an audit finding, a denial, or a partial denial, of an uncompensated care shortfall payment, on-call payment or grant award, the executive director, or designee, shall consider all relevant factors and render a decision upon the written information, without an oral hearing, in a timely fashion. The executive director, or designee, may seek and consider further information from the applicant or supplementation of the application, if necessary or appropriate. #### Regulation .15 Annual Reconciliation Reporting Requirements. *COMAR 10.25.10.15* A. On or before January 31 of each year, a trauma physician or trauma health care practitioner who has received uncompensated care reimbursement from the Fund during the prior calendar year shall file an annual reconciliation report with the Commission. B. The annual reconciliation report shall include: (1) The name, address, and telephone number of the practitioner, practice, or center; (2) The name, address, and telephone number of the practitioner, practice, or center's contact person for the report; (3) The name of the trauma center where care was provided; (4) The amount of money recovered from another payer source for claims that had been reimbursed by the Fund, including: (a) The practitioner's name providing the care; (b) The patient's name, Trauma Registry number, Social Security number, dates of service, and total amount paid by the Trauma Fund; (c) The source of the additional funds received; (d) The amount of the other payment received; and (e) The amount returned to the Trauma Fund; and (5) A certification by an authorized designee of the practitioner, practice, or center that the facts stated in the annual reconciliation report are true and accurate. #### Regulation .16 Prohibited Acts. *COMAR 10.25.10.16* A. An applicant for payment from the Fund may not: (1) Make, or cause to be made, a false statement or false claim; or (2) Engage in fraud in submitting a claim or application. B. Violation of §A of this regulation may result in: (1) Referral to the appropriate Medicaid fraud administrative and prosecutorial authorities, to the Office of the State's Attorney, or both; (2) Rescission of, or an action for recovery of, any prior reimbursement improperly made by the Fund; and (3) Any other appropriate referrals or administrative action. #### Regulation .17 Reporting Requirements to the General Assembly. *COMAR 10.25.10.17* On or before November 1 of each year, the Commission and the HSCRC shall report to the General Assembly in accordance with Health-General Article, §19-130(f) and State Government Article, §2-1246, Annotated Code of Maryland. #### Regulation .18 Expiration of Fund. *COMAR 10.25.10.18* A. This chapter remains in effect unless the Fund ceases to be funded or expires by operation of law. B. In the event the Fund ceases to operate, unless otherwise provided by law, the Fund shall make any final disbursements for the current reporting period based upon available funds. #### Regulation .19 Effective Date. *COMAR 10.25.10.19* Trauma services provided by a trauma health care practitioner to a trauma patient on or after July 1, 2024, are eligible for reimbursement pursuant to the provisions set forth in this chapter. ### Chapter 11 — Institutional Review Board **Authority:** Health-General Article, §§19-109(a)(1) and (7) and (b)(5), 19-103(c)(3), and 19-133(d), Annotated Code of Maryland **Administrative History:** Effective date: March 8, 1999 (26:5 Md. R. 391) **Administrative History:** Regulation .01 amended effective October 14, 2002 (29:20 Md. R. 1589) **Administrative History:** Regulation .01A amended effective August 22, 2011 (38:17 Md. R. 1013) #### Regulation .01 Scope. *COMAR 10.25.11.01* A. This chapter provides one method by which the Commission may consider requests for encounter level data from the Maryland medical care data base and any other Commission data base that contains data elements that qualify as “individually identifiable health information”, as defined in the Health Insurance Portability and Accountability Act of 1996, P.L. 104-191 (1996). The Commission may also use another recognized Institutional Review Board to consider requests for encounter level data from the Maryland medical care data base or any other requests for Commission information that require consideration by an Institutional Review Board. B. This chapter does not apply to: (1) Requests for information from the Maryland medical care data base or any other Commission data base considered public under applicable laws and regulations; or (2) Internal activities of the Commission that are required for it to conduct its lawful business of assembling the Maryland medical care data base, or any other data base that it is authorized to create, and performing research. #### Regulation .02 Definitions. *COMAR 10.25.11.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Application” means a request for information made pursuant to this chapter. (2) “Commission” means the Maryland Health Care Access and Cost Commission. (3) “Data base” means the Maryland medical care data base established at Health-General Article, §19-1507, Annotated Code of Maryland. (4) “IRB” means the Institutional Review Board. (5) “Personal records” has the meaning set forth in State Government Article, §10-624, Annotated Code of Maryland. #### Regulation .03 IRB Membership. *COMAR 10.25.11.03* A. The Commission shall appoint the IRB. B. The IRB shall consist of at least nine members of which: (1) Each member shall have expertise in health services research and information security; and (2) At least one member's primary expertise is ethics. C. The IRB shall be sufficiently qualified through the experience and diversity of its members, including consideration of race, gender, and cultural backgrounds, and sensitivity to such issues as community attitudes to promote respect for its advice and counsel. D. Commission members and Commission staff may not serve on the IRB. Commission staff may provide staff support to the IRB. E. The Commission shall solicit recommendations for appointment to the IRB from organizations and institutions whose mission is related to IRB matters, as the Commission considers appropriate. F. Members shall serve on a volunteer basis for a term not to exceed 3 years. A member may be reappointed. G. The Commission may remove a member for: (1) Misconduct; or (2) Dereliction of duty. #### Regulation .04 IRB Review of Applications. *COMAR 10.25.11.04* A. The IRB shall review all applications submitted pursuant to this chapter. B. The IRB shall recommend: (1) Approval, disapproval, or termination; or (2) Modifications in research or security to secure approval. C. The IRB shall meet as necessary in order to provide timely responses to requests for information. D. Requests for information within the scope of this chapter shall include a description of the: (1) Research use to be made of the information; (2) Intent, if any, to present or publish the findings; (3) Nature of the requested information; (4) Safeguards and procedures that the applicant will take to protect the identity of the data; and (5) A description of any potential risks or benefits. E. Upon receipt of an application within the scope of this chapter, the Commission shall immediately forward the request and all supporting documentation to the IRB for a recommendation. F. The IRB shall require an applicant to provide any: (1) Documentation necessary to satisfy itself that the security of the released data will be preserved; and (2) Information necessary to assist the IRB in making a decision on an application. G. The IRB shall make a timely recommendation concerning release of the requested information. H. An IRB recommendation shall be made on the basis of a majority of the full IRB membership. I. If the IRB denies an application, the IRB shall inform the applicant promptly in writing of the reasons for denial. J. Deliberations. (1) In conducting its deliberations, the IRB shall be mindful of conflicts of interest and the appearance of conflict. (2) IRB members with an actual or apparent conflict concerning a particular application shall recuse themselves from deliberating and voting upon that application. #### Regulation .05 Criteria for Approval. *COMAR 10.25.11.05* The IRB shall recommend approval of an application only if: A. It is satisfied that: (1) The use proposed to be made of the requested information is in the public interest, (2) The risks of release of the requested information are reasonable in relation to the anticipated benefits, and (3) Safeguards adequate to prevent inappropriate disclosures will be implemented by the applicant; and B. The applicant agrees to comply with the requirements of Regulation .12 of this chapter. #### Regulation .06 Commission Review of IRB Recommendations. *COMAR 10.25.11.06* A. The Commission shall review: (1) All IRB recommendations for approval of applications; and (2) IRB denials of applications only for good cause shown by the applicant, which shall consist of evidence demonstrating that the IRB failed to follow the process set forth in this chapter. B. In order to secure Commission review of an IRB denial, an applicant shall file an appeal of the denial with the Commission, together with any supporting memoranda and documentation, within 15 days of the date of receipt of the IRB denial. C. In reviewing an IRB recommendation, the Commission shall consider all relevant factors and render its decision in a timely fashion. In reviewing an IRB recommendation to deny an application, the Commission shall affirm the IRB's decision or, if the evidence warrants, remand the case to the IRB for further consideration. In remanding the matter to the IRB, the Commission shall inform the IRB of the basis for its decision and instruct the IRB concerning any remedial measures which the IRB must take on remand. D. A request for data from the data base is not a contested case under the Administrative Procedure Act. #### Regulation .07 Expedited Review Procedures. *COMAR 10.25.11.07* A. The IRB may use an expedited review procedure to review applications relating to minor changes to already approved information requests. B. Under an expedited review procedure, the review shall be carried out by: (1) The chairperson of the IRB; or (2) An IRB member designated by the chairperson. C. In reviewing the application under an expedited process, the reviewer shall exercise all of the authority of the IRB, except that the reviewer may not disapprove an application. D. An application shall be disapproved only after review in accordance with the nonexpedited procedure set forth in Regulation .04 of this chapter. E. Under an expedited review, Commission approval of an IRB recommendation shall be made only by vote of a majority of the full Commission. #### Regulation .08 Suspension or Termination of IRB Approval. *COMAR 10.25.11.08* A. The Commission shall require an applicant to file periodic progress reports concerning any aspect of the use of data released under this chapter. B. The Commission may: (1) Investigate use made of data released under this chapter; and (2) Require an applicant to provide information necessary to assist the Commission in its investigation. C. The Commission may delegate the function listed in §B of this regulation to the IRB. D. If an applicant fails to make use of the data in accordance with IRB requirements, including IRB data security and confidentiality requirements, the Commission, at the recommendation of the IRB or on its own motion, may: (1) Immediately suspend or terminate its approval of the data release; and (2) Require the applicant to: (a) Return to the Commission, or (b) Destroy previously released data. E. The applicant is entitled to a post-suspension or termination hearing in front of the IRB to show cause why the suspension or termination should be rescinded. Following the hearing, the IRB shall make a recommendation to the Commission concerning reinstatement of the applicant's use of the information. #### Regulation .09 Cooperative Research Activities. *COMAR 10.25.11.09* Data release to a party with which the Commission has contracted pursuant to the State procurement process may not be referred to the IRB. However, other cooperative research activities involving data within the scope of this chapter shall be referred to the IRB for its opinion and recommendation. #### Regulation .10 IRB Records. *COMAR 10.25.11.10* A. The IRB shall maintain the following records: (1) Minutes of all IRB meetings describing: (a) Time and date of the meetings; (b) Members present; (c) Actions taken; (d) Votes on the actions including the number: (i) Voting for; (ii) Voting against; and (iii) Abstaining; (e) The basis for requiring changes in or disapproving research; and (f) A discussion of controverted issues and their resolution; (2) Minutes which shall include: (a) Copies of all applications, supporting documentation, related correspondence, and progress reports; (b) Records of continuing review activities; (c) A list of IRB members and current curriculum vitae sufficient to demonstrate the IRB members' areas of expertise and current employment or consultant relationships and board memberships; and (d) Any written procedures or bylaws adopted by the IRB. B. The IRB shall adhere to the record retention guidelines applicable to the Commission. #### Regulation .11 Completion of Research Activities. *COMAR 10.25.11.11* Upon completion of research conducted with data released under this chapter, the applicant, at the IRB's discretion, shall: A. Destroy or return to the Commission all data and copies of data obtained from the Commission; and B. Provide to the Commission and the IRB a copy of any report, article, paper, or other document prepared by the applicant with use of the released data. #### Regulation .12 Contract Provisions and Penalties. *COMAR 10.25.11.12* As a prerequisite for release of any information under this chapter, the applicant shall enter into an agreement with the Commission which: A. Defines the scope of the use to be made of the released information; B. Provides for safeguards for protecting the identity of data; C. States that a breach of any condition of the agreement is a breach of contract; D. Provides for the return or destruction of data upon a determination of breach of contract by the Commission; and E. Authorizes the Commission to seek all other appropriate remedies for breach of contract. ### Chapter 12 — Imposition of Fines **Authority:** Health-General Article, §§19-109(a)(1) and (7)and 19-116(b)(1) and (2), Annotated Code of Maryland **Administrative History:** Effective date: December 23, 2002 (29:25 Md. R. 1984) #### Regulation .01 Assessment of Fines. *COMAR 10.25.12.01* A. Except as provided in §B of this regulation and unless the Executive Director or the Executive Director's designee has granted an extension of time, a party that fails to timely file a report or other information required by the Commission may be liable for a monetary penalty, not to exceed $1,000 per day, for each day the filing of the report is past due. B. For information required by the Commission pursuant to Health-General Article, §19-116(b), Annotated Code of Maryland, and unless the Executive Director or the Executive Director's designee has granted an extension of time, a party that fails to timely file a report or other information required by the Commission may be liable for a monetary penalty, not to exceed $100 per day, for each day the filing of the report is past due. C. A data report that is substantially incomplete or inaccurate is not timely filed. D. The filing of a written petition for review of a denial of an extension of time stays the accrual of the monetary penalty levied under §§A and B of this regulation. #### Regulation .02 Process for Levying and Appealing an Assessment. *COMAR 10.25.12.02* A. The Executive Director shall determine the amount assessed pursuant to this chapter by considering the factors set forth in Regulation .03. B. The Executive Director shall issue a notice of assessment to a party found to have filed untimely or inaccurate information, explaining the basis for the assessment. C. A party assessed a fine has 10 business days from the date of receipt of the assessment to appeal the assessment to the Commission. D. Upon receipt of an appeal, the Chairman of the Commission may: (1) Schedule a date for hearing the appeal before the full Commission; or (2) Appoint a commissioner to act as a hearing officer. E. Commission staff may participate in the hearing. F. If the Chairman appoints a commissioner as a hearing officer, the hearing officer shall issue a proposed decision containing proposed findings of fact and conclusions of law. G. Parties may file exceptions to the hearing officer's proposed decision with the full Commission. H. Exceptions shall identify specific aspects of the proposed decision with which the excepting party disagrees and explain the basis of the disagreement with specific citation to the record or applicable law. I. The full Commission shall entertain oral argument on exceptions and issue a final decision. J. All hearings shall be conducted in accordance with the procedural requirements of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. #### Regulation .03 Factors Considered in the Assessment of Penalties. *COMAR 10.25.12.03* A. The Commission shall consider the following factors in determining whether to impose a fine and the amount of any fine: (1) The willfulness of the improper conduct; (2) The extent of actual or potential public harm caused by the violation; (3) The cost of auditing or investigating the matter; and (4) The party's history of any previous violation. B. The Commission may suspend or waive any fine for reporting of inaccurate data if the party that filed the inaccurate data reports and corrects the inaccuracies in a timely manner. ### Chapter 13 — Health Information Technology Funding Applications **Authority:** Health-General Article, §19-103(c)(2), Annotated Code of Maryland **Administrative History:** Effective date: December 18, 2006 (33:25 Md. R. 1951) #### Regulation .01 Applicability. *COMAR 10.25.13.01* This chapter applies to the consideration, by the Maryland Health Care Commission, of an application seeking approval for funding that is responsive to an announcement posted by the Maryland Health Care Commission that it will accept applications regarding one or more specified areas of health information technology. #### Regulation .02 Definitions. *COMAR 10.25.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means a person, partnership, firm, association, institution, limited liability company, limited liability partnership, public or private corporation or agency, and shall include at least one rate-regulated hospital, or combination of them. (2) “Approval for funding” means a determination made by the Health Services Cost Review Commission that it will approve an adjustment to hospital rates based on review of an application and recommendation for funding made by the Maryland Health Care Commission for an activity or program proposed by an applicant. (3) “Maryland Health Care Commission (MHCC)” means the agency established by Health-General Article, Title 19, Subtitle 1, Annotated Code of Maryland. (4) “Health Services Cost Review Commission (HSCRC)” means the agency established by Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. #### Regulation .03 Notice of Acceptance of Applications for Funding for Health Information Technology Initiative. *COMAR 10.25.13.03* The Maryland Health Care Commission shall inform potential applicants that it will accept applications seeking approval for funding regarding one or more specified areas of health information technology, by posting an announcement on the MHCC website that includes, but is not limited to, the following: A. Each specific topic to be addressed; B. Required elements; C. Application deadline; D. Application review criteria; E. Method of review; F. Available funding for each application; and G. The maximum number of applications for which funding will be recommended. #### Regulation .04 Review of Applications. *COMAR 10.25.13.04* A. The executive director of the Maryland Health Care Commission: (1) Shall review each application submitted pursuant to this chapter; and (2) May seek the assistance of others in the review. B. The executive director shall forward the results of the review to the Maryland Health Care Commission for its consideration. #### Regulation .05 MHCC Recommendation to the HSCRC; Action by the HSCRC. *COMAR 10.25.13.05* A. The Maryland Health Care Commission shall: (1) Determine which applications merit consideration of approval for funding by the Health Services Cost Review Commission; and (2) For each application recommended for consideration, send to the HSCRC appropriate information that may include the following: (a) A summary of the review criteria and scoring for each recommended application; and (b) A recommended priority order for funding. B. The Health Services Cost Review Commission shall make the final decision on each MHCC-recommended application approved for funding. C. Any funding approved by the HSCRC shall be implemented through reasonable rate adjustments as determined by the HSCRC. ### Chapter 14 — Health Care Data Collection from Maryland Health Care Practitioners **Authority:** Health-General Article, §19-133(b) and (d)(1), Annotated Code of Maryland **Administrative History:** Effective date: November 17, 2008 (35:23 Md. R. 2013) #### Regulation .01 Applicability. *COMAR 10.25.14.01* This chapter applies to the collection of health care data, by the Maryland Health Care Commission, from health care practitioners in the State. #### Regulation .02 Definitions. *COMAR 10.25.14.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Health care” means any care treatment, or procedure by a healthcare practitioner: (a) To diagnose, evaluate, rehabilitate, manage, treat, or maintain the physical or mental condition of a patient; or (b) That affects the structure or any function of the human body. (2) “Health care practitioner” means an individual who is licensed or certified under the Health Occupations Article to provide health care in the State. #### Regulation .03 Information to be Collected. *COMAR 10.25.14.03* The Commission may collect the following data from a health care practitioner: A. Data that indicate the nature of the health care practice in which the health care practitioner is engaged; B. Data that indicate whether the health care practitioner is actively engaged in the practice of health care; C. Data that indicate whether the health care practitioner is currently engaged in direct patient care in the State; D. Data that indicate the health care practitioner's primary language, race, and ethnicity; E. Data that describe the health care practitioner's areas of specialty, including: (1) Specialty qualifications or training; (2) Specialty certification, licensure, or status; and (3) Current areas of concentration; F. Data that identify the number and location of a health care practitioner's practice locations; G. Data that indicate whether the health care practitioner provides primary or preventive care services, or both, in Maryland; H. Data that indicate the nature and extent of the practitioner's use of information technology in the diagnosis and treatment of patients; I. Data that indicate whether the health care practitioner accepts or treats patients who are covered by Maryland Medical Assistance or Medicare; and J. Data that indicate whether the health care practitioner provides care to low-income patients and, if so, the nature of the compensation received for that care. #### Regulation .04 Confidentiality of Information Collected. *COMAR 10.25.14.04* Information collected by the Commission that is required by law to be held confidential may not be disclosed by the Commission to other persons or entities. ### Chapter 15 — Management Service Organization State Designation **Authority:** Health-General Article, §§4-302, 19-103(c)(2)(i) and (ii), 19-109(a)(1), 19-135(a), (b), and (d), and 19-143(h), Annotated Code of Maryland **Administrative History:** Effective date: November 15, 2010 (37:23 Md. R. 1610) **Administrative History:** Regulations .01 — .11 repealed and new Regulations .01 — .08 adopted effective August 18, 2014 (41:16 Md. R. 946) #### Regulation .01 Scope. *COMAR 10.25.15.01* This chapter applies to the State designation of management service organizations. Only a management service organization that is awarded State Designation status by the Maryland Health Care Commission pursuant to this chapter may represent itself as a State-Designated management service organization. #### Regulation .02 Definitions. *COMAR 10.25.15.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Commission” or “MHCC” means the Maryland Health Care Commission. (2) “Electronic health record” or “EHR” means a complete electronic record system that: (a) Contains health-related information on one or more individuals; and (b) Is certified by an authorized testing and certification body designated by the Office of the National Coordinator for Health Information Technology. (3) “Entity” means an individual, trust or estate, general or limited partnership, joint stock company, unincorporated association or society, municipal or other corporation, incorporated association, limited liability partnership, limited liability company, the State, an agency or political subdivision of the State, a court, and any other governmental body. (4) “Executive Director” means the Executive Director of the Commission. (5) “Management service organization” or “MSO” means an entity that provides technology and consultative services to health care providers, and makes available one or more hosted electronic health records systems and other health information technology solutions. (6) “MSO State Designation certificate” means a certificate provided to the MSO by the Commission that documents award of State Designation. (7) “MSO State Designation criteria” means the standards published by the Commission on its website and by notice in the Maryland Register that an MSO must meet to qualify for State Designation. (8) “State Designation” or “State-Designated” means the status awarded by the Commission to an MSO that has met the MSO State Designation criteria required under this chapter. #### Regulation .03 Procedure for Initial State Designation. *COMAR 10.25.15.03* A. Application. (1) An entity seeking MSO State Designation shall submit an application in a form and manner specified by the Commission. (2) The application shall be signed by an individual authorized by the entity submitting the application. B. Requirements for State Designation. An applicant for MSO State Designation shall: (1) Demonstrate that it meets all MSO State Designation criteria in effect at the date of application; (2) Affirm that the applicant, a related entity, or a person or entity that is a principal, owner, operator, or part of management of the entity has never: (a) Pleaded guilty to, been convicted of, or received probation before judgment or similar diversionary disposition for a crime related to the operation of an MSO or for a crime involving fraud, dishonesty, or false dealing; or (b) Been found in violation of State or federal laws or regulations governing the operation of an MSO; (3) Provide all required documentation; (4) Timely provide additional information requested by the Commission as needed to complete the application; and (5) Agree to comply with the requirements of this chapter. C. Review of Applications. (1) Commission staff shall review an application to determine compliance with the State Designation criteria. (2) The Executive Director may approve or deny an application for State Designation, as follows: (a) The Executive Director shall award State Designation to an MSO that meets the requirements set forth in this chapter; and (b) If the Executive Director determines that an application should be denied, the Executive Director shall, within 30 days of receipt of a complete application, notify the applicant in writing of the decision, and include the reasons for denial. D. Duration of State Designation. (1) State Designation is valid for 2 years from the date of issuance of an MSO State Designation certificate, unless suspended or revoked by the Commission. (2) An MSO awarded State Designation shall accept the designation in writing and agree to the comply with the requirements of this chapter. #### Regulation .04 Procedure for Renewal of State Designation. *COMAR 10.25.15.04* A. An application for renewal of State Designation shall: (1) Be made at least 30 days before the expiration of the State Designation in a form and manner specified by the Commission; and (2) Demonstrate compliance with the MSO State Designation criteria in effect at the date of application for renewal. B. Commission staff shall review a renewal application to determine compliance with the State Designation criteria. C. The Executive Director may approve or deny an application for renewal. D. The Executive Director shall renew the State Designation of each MSO that meets the requirements set forth in this chapter. E. If the Executive Director determines that a renewal application should be denied, the Executive Director shall, within 30 days of receipt of a complete application for renewal, notify the applicant in writing of the decision, supported by reasons for denial. #### Regulation .05 Denial of an Initial or Renewal Application. *COMAR 10.25.15.05* A. An MSO whose initial or renewal application was denied may seek Commission review of the denial. B. A written request for Commission review of the denial of an application shall:. (1) Be filed within 20 days of the receipt of the denial; (2) State with particularity the grounds and factual basis for the applicant’s disagreement with the denial; and (3) Be supported by relevant documentation and affidavits. C. The Commission may determine whether or not to affirm the denial of the application or approve the application: (1) After considering the written filing by the MSO and any response by Commission staff; or (2) After hearing oral arguments on the written filings by the MSO and staff. #### Regulation .06 Nontransferability of Designation. *COMAR 10.25.15.06* State Designation issued pursuant to this chapter may not be sold, assigned, leased, or transferred in any way. #### Regulation .07 Closure, Sale, or Transfer of All or Part of a State-Designated MSO. *COMAR 10.25.15.07* A. At least 60 days before the closure, sale, lease, assignment, or transfer of all or part of a State-Designated MSO to any person or entity that was not identified as an owner of the MSO at the time of the most recent certification by the Commission, the State-Designated MSO shall notify the Commission of the impending closure, sale, lease, assignment, or transfer of the State-Designated MSO and timely provide information required or requested by the Commission. B. If all or part of a State-Designated MSO is closed, sold, leased, assigned, or transferred in any person or entity that was not identified as an owner of the MSO at the time of the most recent certification by the Commission, the Commission shall review current State Designation status pursuant to the renewal requirements set forth in Regulation .04 of this chapter. #### Regulation .08 Commission Oversight of State-Designated MSOs. *COMAR 10.25.15.08* A. Commission staff may, on its own initiative or in response to information provided to the Commission, investigate any State-Designated MSO or applicant for State Designation. B. Following an investigation, the Executive Director may issue a notice of proposed action, which may include the following: (1) A time-limited opportunity to correct deficiencies identified by the investigation; (2) Suspension of the State Designation of an MSO for a definite period of time after which, depending upon the circumstances of the case and completion of appropriate corrective actions, the MSO may seek reinstatement of its State Designation; or (3) Revocation of State Designation. C. An MSO that receives a notice of proposed action from the Executive Director may request an opportunity to show cause why the proposed action should not be implemented. A written request to show cause shall be filed with the Commission within 20 days of the issuance of the notice of proposed action and shall: (1) State with particularity the grounds and factual basis for the applicant’s disagreement with the denial; (2) Include each fact upon which the person relies to show cause why the proposed action should not be taken; and (3) Be supported by relevant documentation and affidavits. D. The Commission may determine whether or not to impose the proposed action or a different action: (1) After considering the written show cause filing by the MSO and any response by Commission staff; or (2) After hearing oral arguments on the written filings by the MSO and staff. ### Chapter 16 — Electronic Health Record Incentives **Authority:** Health-General Article, §§19-103(c)(2)(i) and (ii), 19-109(a)(1), and 19-143(d)(1), (2), (3), and (4) and(i), Annotated Code of Maryland **Administrative History:** Effective date: May 16, 2011 (38:10 Md. R. 615) **Administrative History:** Regulation .01 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulation .02B amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulation .03 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulation .04 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulation .05 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulation .06 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulation .07 amended as an emergency provision effective October 21, 2011 (38:24 Md. R. 1495); amended permanently effective January 9, 2012 (38:27 Md. R. 1764) **Administrative History:** Regulations .01 — .07 repealed and new Regulations .01 — .07 adopted effective June 9, 2014 (41:11 Md. R. 605) **Administrative History:** Regulation .01C amended effective November 24, 2016 (43:23 Md. R. 1279) **Administrative History:** Regulation .06A amended effective November 24, 2016 (43:23 Md. R. 1279) #### Regulation .01 Scope. *COMAR 10.25.16.01* A. This chapter applies to each payor that is required to provide an incentive payment to each primary care practice, including a practice owned by a hospital, that adopts and reaches an approved level of use of electronic health records. B. Only a primary care practice that meets the requirements established in this chapter may receive an adoption incentive for electronic health record adoption under this program. C. Adoption incentives under this chapter are available through December 31, 2018. #### Regulation .02 Definitions. *COMAR 10.25.16.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Achieved NCQA level two recognition” means a primary care practice has received recognition from NCQA for meeting NCQA’s 2011 or later standards for a level two patient-centered medical home. (2) “Attested to meaningful use” means a physician or nurse practitioner within a primary care practice has achieved the meaningful use requirements under either the Medicaid or Medicare EHR Incentive Program and has received confirmation of the attestation from: (a) The Centers for Medicare and Medicaid Services; or (b) The Maryland Medical Assistance Program (Medicaid). (3) “EHR adoption incentive” means a payment that an eligible primary care practice can receive from a payor to assist the primary care practice in adopting an electronic health record and attaining a required use level that: (a) Consists of a one-time cash payment not to exceed $15,000 or an incentive of equivalent value agreed upon by the primary care practice and payor; and (b) Is based on a $25 per-patient payment applied to the total number of patients on the practice panel who are Maryland residents. (4) “Electronic health record” or “EHR” means a complete electronic record system that is certified by an authorized testing and certification body designated by the Office of the National Coordinator for Health Information Technology and that contains health-related information on an individual. (5) Fully Insured Health Benefit Plan. (a) “Fully insured health benefit plan” means a medical policy, contract, or certificate for which an: (i) Employer pays a per-employee premium to a payor and the payor assumes the risk of providing health coverage for insured events and incurred administrative costs; or (ii) Individual pays a premium to a payor. (b) “Fully insured health benefit plan” does not include a self-insured health plan or a health plan for which a payor is acting only as a third-party administrator. (6) Health Care Provider. (a) “Health care provider” means a person who is licensed, certified, or otherwise authorized under Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession or in an approved education or training program. (b) “Health care provider” includes a facility where health care is provided to patients or recipients, including: (i) A facility, as defined in Health-General Article, §10-101(e), Annotated Code of Maryland; (ii) A hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (iii) A related institution, as defined in Health-General Article, §19-301, Annotated Code of Maryland; (iv) An outpatient clinic; (v) A freestanding medical facility, as defined in Health-General Article, §19-3A-01, Annotated Code of Maryland; (vi) An ambulatory surgical facility, as defined in Health-General Article, §19-3B-01, Annotated Code of Maryland; and (vii) A nursing home, as defined in Health-General Article, §19-1401, Annotated Code of Maryland. (c) For purposes of this chapter, “health care provider” does not include a health maintenance organization as defined in Health-General Article, §19-701, Annotated Code of Maryland. (7) “Implementation period” means the first 120 days after the effective date of this chapter. (8) “Incentive of equivalent value” means: (a) Specific services; (b) A gain-sharing arrangement; (c) Rewards for quality and efficiency; (d) In-kind payment; or (e) Other items or services that can be assigned a specific monetary value. (9) “Meaningful use” means the criteria and requirements established by the Centers for Medicare and Medicaid Services as detailed under 42 CFR 142, 143, 422, et al. (2010) and subsequent regulations. (10) “Medicare and Medicaid EHR Incentive Programs” means the programs described at 42 CFR 412, 413, 422, and 495 (2010) and 42 CFR 412, 413, and 495 (2012), adopted by the Centers for Medicare and Medicaid Services (CMS) to implement provisions of the American Recovery and Reinvestment Act of 2009, the Medicare EHR Incentive Program as administered by CMS, and the Medicaid EHR Incentive Program as administered by Medicaid. (11) “MHCC” or “Commission” means the Maryland Health Care Commission. (12) “NCQA” means the National Committee for Quality Assurance, a health care quality accreditation, certification, and recognition body. (13) “NPI” or “national provider identifier” means the unique individual identification number issued by the National Provider System to a health care provider typically used in administrative and financial transactions. (14) Payor. (a) “Payor” means a State-regulated carrier that issues or delivers health benefit plans in the State and includes: (i) Aetna, Inc; (ii) CareFirst BlueCross BlueShield; (iii) CIGNA HealthCare Mid-Atlantic; (iv) Coventry Health Care; (v) Kaiser Permanente; and (vi) United Healthcare, Mid-Atlantic Region. (b) “Payor” does not include a managed care organization as defined in Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland. (15) “Practice panel” means: (a) The patients who are Maryland residents and enrolled in a fully insured health benefit plan assigned by a payor to a provider within a primary care practice at the time the primary care practice requests an EHR incentive payment; or (b) When a payor does not assign patients enrolled in a fully insured health benefit plan to a provider within a primary care practice, the patients who are Maryland residents and enrolled with that payor in a fully insured health benefit plan who have been treated by the primary care practice within the 24 months preceding a primary care practice’s request for an EHR adoption incentive payment. (16) “Primary care practice” means a medical practice located in the State that is composed of: (a) One or more physicians who provide health care in family practice, general practice, geriatric medicine, internal medicine, pediatric medicine, or gynecologic practice and that uses one of the following CMS specialty codes in claims submissions: (i) Family practice (08); (ii) General practice (01); (iii) Geriatric medicine (38); (iv) Internal medicine (11); (v) Pediatric medicine (37); or (vi) Obstetrics & Gynecology (16); or (b) One or more nurse practitioners who provide health care in family practice, general practice, geriatric medicine, internal medicine, pediatric medicine, or gynecologic practice and that uses CMS taxonomy code in claims submissions: (i) Adult Health (363LA2100X); (ii) Family (363LF0000X); (iii) Gerontology (363LG0600X ); (iv) Obstetrics & Gynecology (363LX0001X); (v) Pediatric (363LP0200X ); (vi) Primary Care (363LP2300X); or (vii) Women’s Health (363LW0102X). (17) “State” means the State of Maryland. (18) “Third-party administrator” means a person that is registered as an administrator under Insurance Article, Title 8, Subtitle 3, Annotated Code of Maryland. #### Regulation .03 Program Description. *COMAR 10.25.16.03* A. An EHR adoption incentive shall be available to a primary care practice that meets the requirements set forth in Regulation .04 of this chapter. B. A payor may exclude from a primary care practice’s EHR adoption incentive calculation the payor’s patient members who were previously included in another primary care practice’s EHR adoption incentive calculation. C. A payor may, upon notification to a primary care practice: (1) Request additional information from a primary care practice to validate the primary care practice’s EHR adoption incentive request; and (2) Reduce a remaining EHR adoption incentive to a primary care practice if the payor determines that a duplicate payment or an overpayment has been made under this chapter. D. The MHCC may conduct audits to determine compliance with this chapter as follows: (1) A payor shall cooperate with the MHCC’s audit process and file information required by the MHCC in a timely manner; (2) A primary care practice shall cooperate with the MHCC’s audit process and report requested information in a timely manner; and (3) If an audit reveals noncompliance with this chapter, the MHCC may require corrective action. E. This chapter shall also apply to an entity that self-insures its health benefit plans, if federal law is amended to allow state regulation of such EHR payments. #### Regulation .04 Participation Requirements. *COMAR 10.25.16.04* A. To be eligible for an EHR adoption incentive under this chapter, a primary care practice shall: (1) Adopt a certified EHR; (2) Complete and submit an EHR adoption incentive request to each appropriate payor from which the practice desires an incentive award; and (3) Demonstrate that the primary care practice has either: (a) Attested to the current meaningful use requirements under the Medicare or Medicaid EHR Incentive Program; or (b) Participates in any MHCC approved patient-centered medical home program and has achieved NCQA level two recognition. B. An EHR adoption incentive request shall include the following: (1) Practice specific information: (a) Name; (b) Address; (c) Specialty; (d) Organizational national provider identifier number; and (e) Tax identification number; (2) The individual NPIs of each provider within the primary care practice; (3) The estimated total number of patients on the practice panel, if available; (4) The name and version of the certified EHR system implemented by the primary care practice; (5) Documentation that the primary care practice meets the criteria for the EHR adoption incentive including: (a) A copy of the confirmation received from CMS or Medicaid of acceptance of attestation to meaningful use by at least one physician or nurse practitioner within the practice; or (b) A copy of the NCQA level two recognition letter; and (6) An attestation signed by an authorized member of the primary care practice that: (a) The information contained in the request is accurate; (b) If the practice is led by a physician, all the physicians within the primary care practice are using the certified EHR system; and (c) If the practice is led by a nurse practitioner, all the nurse practitioners within the primary care practice are using the certified EHR system C. A payor shall issue an EHR adoption incentive request acknowledgement letter as soon as is reasonably possible and no later than 45 days after receipt of an EHR adoption incentive request. D. The meaningful use attestation of a physician or nurse practitioner may only be included in a single EHR adoption incentive request to a payor. E. A payor may request additional information as necessary to determine the validity of an EHR adoption incentive request. F. A payor shall process and pay in full the adoption incentive within 75 days of receiving a complete EHR adoption incentive request. G. A payor shall provide each primary care practice requesting an EHR adoption incentive with a written notification regarding: (1) The amount of the EHR adoption incentive awarded to the primary care practice; (2) The method of distribution of the EHR adoption incentive; and (3) The time period over which the incentive will be distributed. H. A primary care practice that provided an attestation to meaningful use must give written notice within 90 days to each payor that awarded an EHR adoption incentive to the practice under the following circumstances in the event that the CMS, Medicaid, or its designated entity: (1) Conducted a prepayment or post-payment audit of compliance with the participation requirements of the Medicare or Medicaid EHR Incentive Program regarding the physician or nurse practitioner identified by the primary care practice as part of its EHR adoption incentive request; and (2) Determined that the physician or nurse practitioner had not met the requirements under the Medicare or Medicaid EHR Incentive Program. I. Payors may request reimbursement of the incentive payments made under this chapter to the primary care practice in the event of notice provided by the primary care practice under §H of this regulation. J. Nothing in this chapter shall require a group model health maintenance organization to provide an incentive to a health care provider who is employed by a multispecialty group of physicians or nurse practitioners under contract with the group model health maintenance organization. #### Regulation .05 Incentive Payment Calculation by Payor. *COMAR 10.25.16.05* A. An EHR adoption incentive is calculated at $25 per member, up to a maximum of $15,000, and limited to the payor’s patient members on the practice panel. B. Upon request by a primary care practice, a payor shall provide the practice, in a timely manner, with an accounting of its EHR adoption incentive including the names of each patient included in the EHR adoption incentive calculation. #### Regulation .06 Reporting. *COMAR 10.25.16.06* A. A payor shall submit: (1) An annual report to the MHCC for calendar years 2011 — 2018 no later than 90 days after the end of each calendar year; and (2) At the request of the MHCC, a payor shall submit an interim report within 30 days of the Commission’s request. B. The annual and interim reports shall include: (1) The number of EHR adoption incentive requests received by the payor for the requested calendar year or time period; (2) The number of EHR adoption incentive payment requests processed by the payor for the requested calendar year or time period; (3) The total value of incentives distributed for the calendar year or time period; and (4) Other information available to the payor and requested by the MHCC to determine the effectiveness of EHR adoption incentives programs. C. A payor shall submit a final report to the MHCC no later than May 31, 2017, that includes all information required in an annual report under this regulation. #### Regulation .07 Incentive Program Transition. *COMAR 10.25.16.07* A. A payor has until the end of the implementation period to implement this chapter’s requirements. B. Except as provided in §E of this regulation, a primary care practice that received an incentive under earlier incentive program requirements is not eligible to receive an incentive under the requirements of this replacement chapter. C. A primary care practice may be eligible to receive an incentive provided under the requirements of an earlier EHR adoption incentive regulation if the practice, under an earlier EHR adoption incentive regulation: (1) Did not receive an incentive payment; and (2) Prior to the effective date of this chapter: (a) Submitted an incentive application and payment request; or (b) Submitted an incentive application but not an incentive payment request. D. A primary care practice in §C(1) and (2)(b) of this regulation shall have 60 days after the effective date of this replacement chapter to submit a payment request to the payor for a base and additional incentive, as provided in earlier regulations. E. Within 90 days after the effective date of this replacement chapter, a primary care practice that received an additional incentive that was less than or equal to the base incentive under earlier incentive program requirements may request that the payor award the difference between the previously received incentive payment and the incentive payment calculated under this replacement chapter based on the practice’s eligible patient enrollment with the payor at the time of the original payment. F. A payor shall process a payment request within 75 days of receiving a complete EHR incentive request from a primary care practice submitted under §§C — E of this regulation. ### Chapter 17 — Benchmarks for Preauthorization of Health Care Services **Authority:** Health-General Article, §§19-101 and 19-108.2, Annotated Code of Maryland **Administrative History:** Effective date: February 18, 2013 (40:3 Md. R. 218) **Administrative History:** Regulation .01 amended effective January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .02B amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .03 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .04 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .05 amended effective October 12, 2015 (42:20 Md. R. 1265); January 9, 2023 (49:27 Md. R. 1110) #### Regulation .01 Scope. *COMAR 10.25.17.01* A. This chapter applies to a payor that: (1) Requires preauthorization for health care services; and (2) Is required to report to the Maryland Health Care Commission on its attainment and plans for attainment of certain preauthorization benchmarks. B. This chapter does not apply to a pharmacy benefits manager that only provides services for: (1) Workers’ compensation claims pursuant to Labor and Employment Article, Title 9, Annotated Code of Maryland; or (2) Personal injury protection claims pursuant to Insurance Article, Title 19, Annotated Code of Maryland.. #### Regulation .02 Definitions. *COMAR 10.25.17.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Commission” means the Maryland Health Care Commission. (2) “Executive Director” means the Executive Director of the Commission or the Executive Director’s designee. (3) “Health Care Service” has the meaning stated in Insurance Article, §15-10A-01, Annotated Code of Maryland. (4) “Payor” means one of the following State-regulated entities that require preauthorization for a health care service: (a) An insurer or nonprofit health service plan that provides hospital, medical, or surgical benefits to individuals or groups on an expense-incurred basis under health insurance policies or contracts that are issued or delivered in the State; (b) A health maintenance organization that provides hospital, medical, or surgical benefits to individuals or groups under contracts that are issued or delivered in the State; or (c) A pharmacy benefits manager that is registered with the Maryland Insurance Commissioner, except for a pharmacy benefits manager that only provides services for: (i) Workers’ compensation claims pursuant to Labor and Employment Article, Title 9, Annotated Code of Maryland; or (ii) Personal injury protection claims pursuant to Insurance Article, Title 19, Annotated Code of Maryland. (5) “Preauthorization” means the process of obtaining approval from a payor by meeting certain criteria before a certain health care service can be rendered by the health care provider. (6) “Prescriber” means a health care practitioner who has the required license and, if necessary, scope of practice or delegation agreement that permits the health care practitioner to prescribe drugs to treat medical conditions or diseases. (7) Step therapy or fail-first protocol" is a protocol established by an insurer, a nonprofit health service plan, a health maintenance organization, or a pharmacy benefits manager that requires a certain prescription drug or sequence of prescription drugs to be used by an insured individual or an enrollee before another specific prescription drug ordered by a prescriber is covered. (8) “Supporting medical information” means: (a) A paid claim from a payor that requires a step therapy or fail-first protocol for an insured or an enrollee; (b) A pharmacy record that documents that a prescription has been filled and delivered to an insured or enrollee, or to a representative of an insured or enrollee; or (c) Other information mutually agreed to that constitutes sufficient supporting medical information by an insured's or enrollee’s prescriber and a payor that requires a step therapy or fail-first protocol. #### Regulation .03 Benchmarks. *COMAR 10.25.17.03* A. Each payor shall establish and maintain online access for a provider to the following: (1) A list of each health care service that requires preauthorization by the payor; and (2) Key criteria used by the payor for making a determination on a preauthorization request. B. Each payor shall establish and maintain an online process for: (1) Accepting electronically a preauthorization request from a provider; and (2) Assigning to a preauthorization request a unique electronic identification number that a provider may use to track the request during the preauthorization process, whether the request is tracked electronically, through a call center, or by fax. C. Each payor shall establish and maintain an online preauthorization system that meets the requirements of Health-General Article, §19-108.2(e), Annotated Code of Maryland, to: (1) Approve in real time, electronic preauthorization requests for pharmaceutical services: (a) For which no additional information is needed by the payor to process the preauthorization request; and (b) That meet the payor’s criteria for approval; (2) Render a determination within 1 business day after receiving all pertinent information on requests not approved in real time, electronic preauthorization requests for pharmaceutical services that: (a) Are not urgent; and (b) Do not meet the standards for real-time approval under §C(1) of this regulation; and (3) Render a determination within 2 business days after receiving all pertinent information, electronic preauthorization requests for health care services, except pharmaceutical services, that are not urgent. D. Each payor that requires a step therapy or fail-first protocol shall: (1) Establish and maintain an online process to allow a prescriber to override the step therapy or fail-first protocol if: (a) The step therapy drug has not been approved by the United States Food and Drug Administration for the medical condition being treated; or (b) A prescriber provides supporting medical information to the payor that a prescription drug covered by the payor: (i) Was ordered by the prescriber for the insured or enrollee within the past 180 days; and (ii) Based on the professional judgment of the prescriber, was effective in treating the insured's or enrollee's disease or medical condition; (2) Provide notice to prescribers regarding the availability of its online process; and (3) Provide information to insureds or enrollees on the availability of the step therapy or fail-first protocol within its network. E. A payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, shall meet each benchmark within this chapter within 3 months of the payor's offering of services or benefits within the State and shall thereafter maintain the processes or actions required by each benchmark. #### Regulation .04 Reporting. *COMAR 10.25.17.04* A. A payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, shall report to the Commission in a form and manner specified by the Commission on its attainment of each benchmark in Regulation .03 of this chapter within 3 months of the payor’s offering of services or benefits within the State. B. If requested by the Commission, a payor shall demonstrate continued compliance with the benchmarks in Regulation .03 of this chapter. C. A payor that has been granted a waiver under Regulation .05 of this chapter shall notify the Executive Director if it can no longer demonstrate the extenuating circumstances for which the waiver was granted within 30 days after a payor can no longer demonstrate extenuating circumstances. #### Regulation .05 Waiver from Benchmark Requirement. *COMAR 10.25.17.05* A. A payor may request that the Commission issue or renew a waiver from the requirement to meet a benchmark in Regulation .03 of this chapter by the demonstration of the following extenuating circumstances: (1) For an insurer or nonprofit health service plan, a premium volume that is less than $1,000,000 annually in the State; (2) For a group model health maintenance organization, as defined in Health-General Article, §19-713.6, Annotated Code of Maryland, preauthorizations of health care services requested by providers not employed by the group model health maintenance organization; or (3) Other circumstances determined by the Executive Director to be extenuating. B. Submission of Request for Waiver or Renewal of Waiver. (1) A request for a waiver or renewal of waiver shall be in writing and shall include: (a) An identification of each preauthorization benchmark for which a waiver is requested; and (b) A detailed explanation of the extenuating circumstances necessitating the waiver. (2) A request for a waiver shall be filed with the Commission in accordance with the following: (a) For renewal of a waiver, no later than 30 days prior to its expiration; or (b) For a payor that becomes authorized to provide benefits or services within the State of Maryland after October 1, 2012, within 3 months after the date the payor is authorized to provide benefits or services within the State. C. Issuance of Waiver. (1) The Executive Director may issue a waiver from a preauthorization benchmark to a payor that demonstrates extenuating circumstances within this chapter. (2) The Executive Director will review and provide a decision to approve or deny all waiver requests within a reasonable time frame. (3) A waiver or renewal of a waiver shall be valid for 2 years, unless withdrawn by the Executive Director. D. Withdrawal of Waiver. (1) The Executive Director may withdraw a waiver or renewal of a waiver if the Executive Director determines that the payor can no longer demonstrate extenuating circumstances. (2) If the Executive Director withdraws a waiver or renewal of waiver, the Executive Director shall notify the payor, setting forth in writing the reasons for withdrawal. (3) After a waiver or a renewal of a waiver is withdrawn, a payor shall submit a plan to the Executive Director within 30 days that includes a timeline for attaining each benchmark in Regulation .03 of this chapter in a format approved by the Commission. E. Review of Denial or Withdrawal of Waiver. (1) If the Executive Director has denied or withdrawn a waiver, a payor may seek Commission review of the denial or withdrawal by filing a written request for review with the Commission within 20 days of receipt of the Executive Director’s notice of denial or withdrawal of a waiver, which shall: (a) State with particularity the grounds and factual basis for a payor’s disagreement with the denial or withdrawal decision; (b) Specify the remedy requested; and (c) If desired, include a written request to orally address the Commission, which shall be scheduled if requested. (2) The full Commission may review the written request for review of a denial or withdrawal of a waiver directly or, at the discretion of the Chair of the Commission, appoint a Commissioner to review the request submitted under §E(1) of this regulation, who will make a recommendation to the full Commission. (3) If a written request was submitted under §E(1)(c) of this regulation, a payor may orally address the Commission before a determination is made by the Commission as to whether or not to issue or withdraw a waiver. (4) After reviewing and considering a payor’s written request for review of the denial or withdrawal decision and any oral argument, if applicable, the full Commission shall issue a written decision affirming, reversing, or modifying the decision reviewed. F. A waiver or renewal of waiver from the requirements of this chapter may not be sold, assigned, leased, or transferred. #### Regulation .06 Fines. *COMAR 10.25.17.06* A payor that does not meet the reporting requirements of this chapter may be assessed a fine in accordance with COMAR 10.25.12.01, et seq. ### Chapter 18 — Health Information Exchanges: Privacy and Security of Protected Health Information **Authority:** Health-General Article, §§4-301, 4-302.2, 4-302.3, 4-302.5, 4-304, 19-103, 19-109(a)(1) and (8), 19-133, 19-143, and 19-145, Annotated Code of Maryland **Administrative History:** Effective date: March 17, 2014 (41:5 Md. R. 344) **Administrative History:** Regulation .01 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .01A,B amended effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .01B amended effective August 13, 2018 (45:16 Md. R. 775) **Administrative History:** Regulation .01B, E amended effective April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .01F adopted effective April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .02B amended effective June 20, 2016 (43:12 Md. R. 666); June 19, 2017 (44:12 Md. R. 588); August 13, 2018 (45:16 Md. R. 775); April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .02B amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .03 amended effective June 20, 2016 (43:12 Md. R. 666); June 19, 2017 (44:12 Md. R. 588); April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .03B, G amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .03D amended effective August 13, 2018 (45:16 Md. R. 775) **Administrative History:** Regulation .04 amended effective August 13, 2018 (45:16 Md. R. 775); April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .04 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .05 amended effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .06 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .06A, F amended effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .07 amended effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .07C amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .08 amended effective June 19, 2017 (44:12 Md. R. 588) **Administrative History:** Regulation .08C amended effective June 20, 2016 (43:12 Md. R. 666); April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .09 amended effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .09 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .09G adopted effective June 19, 2017 (44:12 Md. R. 588) **Administrative History:** Regulation .10 adopted effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .10 amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .10A, B amended effective August 13, 2018 (45:16 Md. R. 775) **Administrative History:** Regulation .10B amended effective April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .11 adopted effective June 20, 2016 (43:12 Md. R. 666) **Administrative History:** Regulation .11B amended effective August 13, 2018 (45:16 Md. R. 775) **Administrative History:** Regulation .11B amended as an emergency provision effective January 9, 2024 (51:3 Md. R. 152); amended permanently effective May 13, 2024 (51:9 Md. R. 440) **Administrative History:** Regulation .12 adopted effective June 19, 2017 (44:12 Md. R. 588) **Administrative History:** Regulation .12A amended effective August 13, 2018 (45:16 Md. R. 775) **Administrative History:** Regulation .13 adopted effective April 14, 2025 (52:7 Md. R. 322) **Administrative History:** Regulation .14 adopted effective April 14, 2025 (52:7 Md. R. 322) #### Regulation .01 Scope and Purpose. *COMAR 10.25.18.01* A. This chapter addresses the privacy and security of protected health information maintained by a health information exchange, or obtained or released by any person through a health information exchange by adopting specific requirements: (1) To assure the privacy and security of protected health information accessed, used, or disclosed through a health information exchange, including protections for the secondary use of protected health information obtained, accessed, or released through a health information exchange; (2) To govern the access, use, maintenance, and disclosure of protected health information through or by a health information exchange; (3) To improve access to clinical records by treating clinicians; and (4) To promote uses of a State-designated HIE that will assist public health agencies in reaching public health goals. B. This chapter applies to: (1) An HIE, as defined in Regulation .02B(38) of this chapter, including: (a) An individual or entity that determines, controls, or has discretion to administer any requirement, policy, or agreement that allows, enables, or requires the use of any technology or services for access, exchange, or use of electronic protected health information: (i) Among more than two unaffiliated individuals or entities that are enabled to exchange electronic protected health information with each other; and (ii) That is for a treatment, payment, or health care operations purpose, as those terms are defined in 45 CFR §164.501, regardless of whether the individuals or entities are subject to the requirements of 45 CFR Parts 160 and 164; and (b) A health information technology developer of certified health information technology as that term is defined in Regulation .02B(39) of this chapter; (2) A person who accesses, uses, or discloses protected health information through an HIE; (3) Electronic health information stored in, or maintained by, an HIE; and (4) A dispenser authorized by law to dispense noncontrolled prescription drugs to a patient or the patient’s agent in the State. C. This chapter does not apply to: (1) Protected health information exchanged, accessed, used, or disclosed: (a) Between a hospital and a credentialed professional; (b) Among credentialed professionals of a hospital’s medical staff; (c) Between a hospital and its affiliated ancillary clinical service provider who is affiliated with the hospital and who, if required by HIPAA, has entered into a business associate agreement with the hospital; (d) Among entities under common ownership as defined at Health-General Article, §4-301, Annotated Code of Maryland, for health care treatment, payment, or health care operations purposes, as those terms are defined in 45 CFR §164.501; (e) By a carrier, as defined in Insurance Article, §15-301, Annotated Code of Maryland, exchanging information as required by 45 CFR §156.221; or (f) Between a carrier and its business associate, as defined in 45 CFR §160.103, if the organizational and technical processes provided or governed by the business associate are transactions, as defined in 45 CFR §160.103; or (2) The use, access, or disclosure of protected health information using point-to-point transmission unless an HIE is involved in the transmission of the data. D. In the event that an HIE is unable to meet a requirement of this chapter independently, it may do so by the execution of a written agreement or by requesting an exemption in accordance with Regulation .09G or H of this chapter. E. The requirements in this chapter are in addition to those set forth below: (1) The Health Insurance Portability and Accountability Act of 1996, and the pertinent regulations at 45 CFR Parts 160 and 164; (2) The Maryland Consumer Protection Act, Commercial Law Article, Title 13, Annotated Code of Maryland; (3) The Maryland Personal Information Protection Act, Commercial Law Article, Title 14, Subtitle 35, Annotated Code of Maryland; (4) The Maryland Confidentiality of Medical Records Act, Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; (5) Health General Article, §4-307, Annotated Code of Maryland, Confidentiality of Mental Health Records; (6) 16 CFR Part 318, Health Breach Notification Rule, adopted by the Federal Trade Commission pursuant to the HITECH Act; (7) 42 CFR Part 2, Confidentiality of Substance Use Disorder Patient Records; (8) Titles IV and XI of the 21st Century Cures Act and the pertinent regulations, 45 CFR Part 171, and as defined at Regulation .02B(78) of this chapter; and (9) All other applicable State and federal laws and regulations governing the use, access, maintenance, and disclosure of health information. F. Nothing in this chapter shall prohibit: (1) The Maryland Department of Health, the Commission, or the Health Services Cost Review Commission from using electronic health information, subject to federal and State law, for health regulatory and public health functions; (2) The sharing or disclosing of information that is required to be exchanged under Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland; or (3) The sharing or disclosing of information that is required to be exchanged under federal law, including for the purposes of payment, as defined in 45 CFR § 164.501. #### Regulation .02 Definitions. *COMAR 10.25.18.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adjudication of claims” means the activities necessary for the adjudication or subrogation of a health benefit claim that has been filed or may be filed by a patient, or with the authorization of a patient on the patient’s behalf, including: (a) Determinations of eligibility or coverage, including coordination of benefits or the determination of cost-sharing amounts; (b) Reasonable prospective, concurrent, or retrospective utilization review or predetermination of benefit coverage; (c) Review, audit, and investigation of a specific claim for payment of benefits with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges; (d) Billing, claims management, collection activities, obtaining payment under a contract for reinsurance, and related health care data processing; and (e) Risk adjustments based on enrollee health status and demographic characteristics. (2) “Ancillary clinical service provider” means a health care provider who has a direct contractual agreement with the hospital to provide therapeutic, diagnostic, or custodial ancillary services for the hospital as part of its affiliation. Ancillary services may include skilled nursing, home care, outpatient rehabilitation and therapy, transportation, ambulatory surgery, dialysis, laboratory, radiology, pharmacy, and chemotherapy. (3) “Application Programming Interface” or “API” has the same meaning as ‘Certified API Technology’ as stated at 45 CFR § 170.404. (4) “Appropriate notice to one or more health care consumers” means notice, related to a request for individually identifiable health information for secondary use, that meets the following requirements: (a) The notice: (i) Must include educational information pertaining to the requesting entity's secondary use of data obtained through an HIE, including why the entity is requesting the data and how it intends to use the data; (ii) May describe an ongoing scenario such as care coordination or other ongoing care management activities against which subsequent data may be requested by the care management organization from the HIE; in such cases, the potential need for and nature of such requests shall be included in the description of the initial request to the external review board and shall be plainly documented in the notice to health care consumers; (iii) Must include a clear and detailed description of the steps a health care consumer must take in order to grant authorization for the use of their information or to deny authorization; (iv) Must provide clear, detailed notice that the health care consumer's failure to respond could result in their information being disclosed without their authorization, if an independent external review committee waives authorization; and (v) Must have characteristics detailed in Regulation .03B(2)(b)—(g) of this chapter. (b) The care management organization, or its third party, has provided to each health care consumer whose identifiable information is being requested: (i) Notice as described above, using varied methods, where possible, to reach the health care consumer; (ii) The opportunity to submit authorization or denial of authorization through various methods such as email, online, mail, and phone; and (iii) At least 30 calendar days from the time of the first notice to respond to the notice. (5) “Authentication” means the process of establishing confidence in user identities electronically presented to an information system. (6) “Authorization” has the meaning provided in 45 CFR §164.508. (7) “Authorized purpose” means the specific reason consistent with this chapter and State and federal law for which an authorized user may use, access, or disclose protected health information through or from an HIE. The authorized purpose may include daily operations and maintenance of the HIE for: (a) The staff of the HIE who has signed a confidentiality and nondisclosure agreement; and (b) The staff of the HIE's contractor if the contractor: (i) Has entered into a business associate agreement with the HIE; and (ii) Has contractually agreed to limit access to the HIE only to its employees, agents, and independent contractors with a need-to-know; and who are under a confidentiality restriction, which may include a binding work force policy and procedure. (8) “Authorized user” means an individual identified by a participating organization or a health information exchange, including a health care consumer, who may use, access, or disclose protected health information through or from a health information exchange for a specific authorized purpose and whose HIE access is not currently suspended or terminated under Regulation .05, .07, or .09 of this chapter. (9) “Breach” has the meaning provided in 45 CFR §164.402. (10) “Business associate” has the meaning provided in 45 CFR §160.103. (11) “Business day” means any day except Saturday, Sunday, or a holiday on which State offices are closed. (12) “Care management organization”, in the context of secondary use, means any entity that: (a) Has a financial or specific care-related responsibilities for individuals with whom they may not have a treatment, payment, or health care operations relationship under 45 CFR §164.501(1); and (b) Has the legal or regulatory authority to exercise the responsibilities stated in §B(12)(a) of this regulation; or (c) Is operating in accordance with Maryland's All-Payer Model or successor agreement between the Centers for Medicare and Medicaid Services and the State of Maryland; (d) Does not include a third-party entity engaged by a participating organization to provide care management services on behalf of such participating organization for a primary use. (13) “Commission” means the Maryland Health Care Commission. (14) “Consent management application” means a software tool or platform designed to request, receive, store, and manage a person in interest’s consent preferences regarding the sharing of the patient’s electronic health information through an HIE. (15) “Control” means providing a method by which the health care consumer can electronically provide instructions to an HIE regarding the disclosure of the patient's information being made available through the HIE, which may include specifying: (a) The individuals and organizations to whom the HIE may disclose the patient's health information; (b) The circumstances (e.g., all, emergency only, inpatient, etc.) under which the patient's health information may be disclosed through the HIE; and (c) What type of health information may be disclosed, such as prescription history, laboratory reports, hospital encounters, and to whom. (16) “Core elements of the Master Patient Index (MPI)” are the minimum elements that are required for an HIE to identify a particular patient across separate clinical, financial, and administrative systems, as needed for exchanging health information electronically. (17) “Core HIE education content” means the educational information developed and approved by the Maryland Health Care Commission, after consultation with interested parties, and includes a general overview of: (a) The fundamentals of health information technology, including electronic health records and the exchange of electronic health information; (b) Health information privacy and security laws; and (c) The benefits and risks to patients of exchanging health information through an HIE as compared to opting-out and exchanging health information through a paper-based system. (18) “Covered entity"” has the meaning provided in 45 CFR §160.103. (19) “Credentialed professional” means an individual who has been credentialed by a hospital to provide clinical services to patients of the hospital. Credentialing includes the formal evaluation and verification of an individual's necessary qualifications, education, training, and professional license if applicable, through the collection, verification, and evaluation of data relevant to the individual's professional performance. (20) “Data use agreement” means an agreement that: (a) Is entered into by an HIE and an entity receiving data for secondary data use purposes, regardless of whether or not the entity is a covered entity as defined by HIPAA; and (b) Requires: (i) The receiving entity to accept and comply with the requirements in this chapter and, to the extent the receiving entity meets the definition of a business associate under HIPAA, current State and federal laws pertaining to business associates and business associate agreements; (ii) Both parties to access, transmit, and protect the PHI in accordance with current legal requirements and industry standards and practices; (iii) The receiving entity to destroy the PHI, including back-up and archived copies of the PHI, in accordance with industry standards and practices, when the purposes for which it has been requested are completed, unless retention of the PHI is otherwise required by law; and (iv) The receiving entity not to reuse or disclose the PHI to any person or organization, except as required or permitted by law; or if disclosed to a third party, which will act on behalf of the receiving entity, the third party and the receiving entity enter a contractual agreement that requires the third party to be bound by the provisions of the data use agreement that applies to the receiving entity. (21) “De-identified data” means health information that neither identifies nor provides a reasonable basis to identify an individual and that meets the standards and specifications provided in 45 CFR §164.514(a)—(b). (22) “Disclose” or “disclosure” means the release, redisclosure, transfer, provision, access, transmission, communication, or divulgence in any other manner of health information, including an acknowledgment that a health record on a particular patient or recipient exists, outside the entity holding the information. (23) “Dispense” has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland, but does not include giving a patient prescription drug samples in accordance with Health Occupations Article, §12-102(d), Annotated Code of Maryland. (24) Dispenser. (a) “Dispenser” means a person authorized by law to dispense a noncontrolled prescription drug to a patient or a patient’s agent in the State, including a nonresident pharmacy so authorized. (b) “Dispenser” does not include: (i) A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital; (ii) An opioid treatment services program, as defined by COMAR 10.47.07.02; (iii) A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland; (iv) A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; or (v) A pharmacy issued a waiver by the Department under COMAR 10.47.07.03G from reporting dispensing to hospice patients. (25) “Download” means providing a method by which the health care consumer can obtain an electronic copy of the patient's information that: (a) Is in a readily available industry standard format; and (b) Allows the health care consumer to save, maintain, use, or transmit the patient's information. (26) “Electronic health care transactions” means transactions, as defined by 45 CFR § 160.103, that meet the specifications of 45 CFR § 162.920. (27) “Electronic health information” means health information that is in an electronic form. (28) “Electronic health record” or “EHR” means an electronic record of health-related information on an individual that includes patient demographic and clinical health information that may be used for clinical diagnosis, treatment, improvement of health care quality, and patient care. (29) “Electronic health record system” means technology that electronically captures, manages, and organizes health records and may have the capacity to: (a) Provide clinical decision support; (b) Support physician order entry; (c) Capture and query information relevant to health care quality; and (d) Exchange electronic health information with and integrate the information from other sources. (30) “Emergency” has the meaning provided in Health-General Article, §4-301(d), Annotated Code of Maryland. (31) “External and independent review committee” means a group of individuals that: (a) Is responsible for reviewing and making a determination regarding a request for a waiver of authorization related to population health management; and (b) Shall be minimally composed of: (i) At least three health care consumer members, three health care provider members, one member representing the scientific community, one member with privacy and legal expertise, and one member with HIE expertise; (ii) Members who have appropriate professional competencies necessary to review the request; and (iii) More than half of the members are not affiliated with or related to any person affiliated with the requesting entity and are free from any conflicts of interest with the requesting entity. (32) “Federalwide assurance” or “FWA” means an agreement between an entity and the United States Department of Health and Human Services under which the entity agrees to comply with: (a) Federal regulations concerning research involving human subjects; (b) Department of Health and Human Services regulations found at 45 CFR Part 46; (c) A statement of principles governing the entity in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the entity; and (d) Other requirements of the agreement. (33) “Granular patient consent” means expressed preferences made by a health care consumer regarding the disclosure, access, and use of the patient's protected health information according to the type of information, type of provider, purpose, or circumstance communicated by the health care consumer to the HIE through reasonable means specified by the HIE, which shall include paper and electronic means. (34) “Health care” has the meaning provided in Health-General Article, §4-301(g), Annotated Code of Maryland. (35) “Health care consumer” or “consumer” means a recipient, a patient, or a person in interest, as defined in this regulation. (36) “Health care provider” has the meaning provided in Health-General Article, §4-301(h), Annotated Code of Maryland. (37) “Health Data Utility” means an HIE that operates for the following purposes: (a) The collection, aggregation, and analysis of clinical information, public health data, and electronic administrative health care transactions; (b) The communication of data between public health officials and health care providers to advance disease control and health equity; and (c) The enhancement and acceleration of interoperability of health information. (38) “Health information” means any information, whether oral or recorded in any form or medium, including electronic health information, that: (a) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and (b) Relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual. (39) “Health information exchange” or “HIE” has the meaning provided in Health-General Article §4-301(i), Annotated Code of Maryland. (40) “Health information technology developer of certified health information technology” or “developer” means an entity that develops, sells, licenses, provides, or offers health information technology, as defined in 42 U.S.C. 300jj(5), to persons in the State and has one or more health information technology modules certified under a program that is kept or recognized by the National Coordinator in accordance with 42 U.S.C. 300jj-11(c)(5). (41) Health Record. (a) “Health record” means any health information, in any form or medium, created or transmitted by a participating organization or health care consumer that: (i) Is entered in the record of a patient or recipient; and (ii) Identifies or can readily be associated with the identity of a patient or a recipient. (b) “Health record” includes a medical record as defined in Health-General §4-301(k), Annotated Code of Maryland. (42) “HIE access matrix” means a document that is used by a participating organization to assign access to each authorized user and describes the type of protected health information (including, but not limited to, lab reports, prescription drug information, prior admissions to hospitals), that each authorized user is allowed to retrieve from an HIE. An HIE access matrix may specify a use case (including but not limited to electronic eligibility, clinical lab ordering/results delivery, electronic prescribing, medication history, clinical summary exchange, and other items) and corresponding associated data, including identified sensitive health information. (43) “HIPAA” means the Health Insurance Portability and Accountability Act of 1996, P.L.104191, as amended, and the implementing regulations at 45 CFR Parts 160 and 164, as amended, and including as amended by the HITECH Act. (44) “HITECH Act” mean the Health Information Technology for Economic and Clinical Health Act, Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), as amended. (45) “Hospital” has the meaning provided in Health-General Article, §19-301(f), Annotated Code of Maryland. (46) “Improvement of patient safety” means actions, strategies, or protocols to prevent health care errors, enhance the quality of care, and ensure a safe health care environment. (47) “Individually identifiable health information” has the meaning provided in 45 CFR §160.103 and includes any health information that contains personal identifiers, as detailed in 45 CFR §164.514(b). (48) “Institutional Review Board” or “IRB” means a committee or other group designated by an institution or affiliated with a State agency that performs a review of proposed research that has: (a) Registered with the Office of Human Research Protections Electronic Submission System; and (b) Obtained FWA approval from the Office of Human Research Protections. (49) “Interoperability” has the meaning provided in 45 CFR §170.102. (50) “Legally protected health information” means the health information with a date of service after May 31, 2022, that is subject to restrictions under Health-General Article, §4-302.5, Annotated Code of Maryland, and COMAR 10.11.08, including: (a) Mifepristone data, as defined by the Secretary; and (b) As specified by the Secretary, the diagnosis, procedure, medication, and other codes related to: (i) Abortion care; and (ii) Sensitive health services, as defined by Health-General, §4-301, Annotated Code of Maryland. (51) “Master patient index” or “MPI” means a database that maintains a unique index identifier for each patient whose protected health information may be accessible through an HIE and is used to cross reference patient identifiers across multiple participating organizations to allow for patient search, patient matching, and consolidation of duplicate records. (52) “MHCC” or the “Commission” means the Maryland Health Care Commission. (53) “Nationally recognized standards” means technical standards for the exchange, integration, sharing, or retrieval of electronic health information considered reliable by the health IT industry nationally. (54) “Noncontrolled Prescription Drugs” means a prescription drug, as defined in the Health Occupations Article § 21 201, that is not a controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. (55) “Non-HIPAA violation” means an inappropriate use, access, maintenance, or disclosure of health information that is not a HIPAA violation, but is inconsistent with State or federal law or this chapter, including a violation of 42 CFR Part 2. (56) “Notice” (or “notify” or “notification”) means an action that is required to be taken in writing or by written request under this chapter by a person, including an HIE, a health care consumer, a participating organization, or the Commission, in order to provide information to another that: (a) Is sent by letter delivered to the person's address of record; (b) Uses one of the following electronic or digital mechanisms where the delivery is acknowledged or confirmed: (i) An email, when the receiving person has provided an email address; (ii) By a health care consumer using the receiver's website; or (iii) By a health care consumer using a patient portal; (c) By a health care consumer using telephonic or similar method, provided that a written confirmation of the conversation is provided to the health care consumer by the person receiving the notification or request by the following means: (i) An email, when the health care consumer has provided an email address and delivery is acknowledged or confirmed; or (ii) A letter delivered to the health care consumer's address of record; and (d) Complies with HIPAA and all other applicable federal and State laws and regulations. (57) “Opt out” means the explicit written notice by a health care consumer to an HIE or through the consent management application that the patient has elected not to participate in the HIE, so that the HIE shall not disclose such patient's protected health information, or data derived from such patient's health information, except as consistent with this chapter. (58) “Part 2” means the federal Confidentiality of Substance Use Disorder Patient Records regulations found in 42 CFR Part 2 and supplemented by the final rule 82 FR 6052. (59) “Part 2 information” means any information subject to the regulations under 42 CFR Part 2. (60) “Participating organization” means a covered entity that enters into an agreement with an HIE that governs the terms and conditions under which its authorized users may use, access, or disclose protected health information through the HIE. (61) “Patient” means an individual who receives health care and on whom a medical record is maintained. (62) “Payor” means: (a) An insurer that holds a certificate of authority in the State and provides health benefit plans in the State; (b) A health maintenance organization that holds a certificate of authority in the State; (c) A managed care organization authorized to receive Medicaid prepaid capitation payments under Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland; or (d) A nonprofit health service plan that holds a certificate of authority in the State. (63) “Person” means an individual, trust or estate, general or limited partnership, joint stock company, unincorporated association or society, municipal or other corporation, incorporated association, limited liability partnership, limited liability company, the State, an agency or political subdivision of the State, a court, and any other governmental entity. (64) “Person in interest” means any of the following, but does not include a participating organization: (a) An adult on whom a health care provider maintains a medical record; (b) A person authorized to consent to health care for an adult consistent with the authority granted, including without limitation, a guardian, surrogate, or person with a medical power of attorney; (c) A duly appointed personal representative of a deceased person; (d) Either: (i) A minor, if the medical record concerns treatment to which the minor has the right to consent and has consented under Title 20, Subtitle 1 of the Health-General Article, Annotated Code of Maryland; or (ii) A parent, guardian, custodian, or a representative of the minor designated by a court, in the discretion of the attending physician who provided the treatment to the minor, as provided in Health-General Article, §§20 -102 and 20-104, Annotated Code of Maryland; or (e) If §B(55)(d) of this regulation does not apply to a minor: (i) A parent of the minor, except if the parent's authority to consent to health care for the minor has been specifically limited by a court order or a valid separation agreement entered into by the parents of the minor; or (ii) A person authorized to consent to health care for the minor consistent with the authority granted; or (f) An attorney appointed in writing by a person listed in this definition regarding matters subject to this chapter. (65) “Point-to-point transmission” means a secure electronic transmission of PHI, including, but not limited to, records sent via facsimile or secure clinical messaging service, sent by a single entity that can be read only by the single receiving entity designated by the sender. A point-to-point transmission may be facilitated by an HIE and mirrors a paper-based exchange, such as a referral to a specialist, a discharge summary sent to where the patient is transferred, lab results sent to the practitioner who ordered them, or clinical information sent from a hospital to the patient's health plan for quality improvement or care management/coordination activities for such patient. (66) “Population health management purpose” means the use of data, for secondary use, available from or through an HIE for population-based activities relating to the improvement of patient and population health or the reduction of health care costs, including but not limited to: (a) Patient outreach activities that involve care management; (b) Development or assessment of, quality indicators, patient patterns or outcomes, or support of quality reporting; (c) Development and evaluation of innovative care delivery models and programs; and (d) Risk assessment. (67) “Primary use of HIE data” or “primary use” means use and disclosure of data accessed, used, or disclosed through an HIE for purposes of: (a) Treatment as defined by HIPAA; (b) Payment as defined by HIPAA; (c) Reporting to public health authorities in compliance with reporting required or permitted by law; (d) Other uses or disclosures required or permitted by law and in accordance with this chapter, including those set forth in Health-General Article, §4-305(b), Annotated Code of Maryland; or (e) Health care operations, as defined by HIPAA, for conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities. (68) “Privacy board” means a group of individuals that: (a) Is responsible for reviewing and making a determination on a request for secondary data for research purposes; (b) Has the authority consistent with 45 CFR §164.512, including approval of a waiver or alteration of authorization requirement; (c) Is designated or convened by the HIE, which may establish guidelines concerning a quorum; (d) Shall meet the member composition requirements detailed in 45 CFR §164.512(i)(1)(i)(B)(1) and (3); and (e) Shall assure that less than half of its members considering a request are affiliated with or related to any person affiliated with the requesting entity. (69) “Protected health information” or “PHI” a subset of health information, means: (a) Protected health information as defined in 45 CFR §160.103; or (b) A medical record as defined in the Health-General Article, §4-301(i); and (c) Includes sensitive health information. (70) “Public health authority” has the meaning provided in 45 CFR §164.501. (71) “Qualified research organization” means an entity that: (a) Has entered into a data use agreement with the HIE from which data is being requested; (b) Is determined, by an IRB or privacy board, to have expertise to carry out research specific to its request; (c) Is determined, by an IRB or privacy board, to have a legitimate and credible reason or obligation to carry out research specific to its request; and (d) Is a participating organization, public health authority, or is engaged in joint research with a participating organization or public health authority. (72) “Query” means to electronically search for information available through an HIE using the services provided by the HIE. (73) “Research” means the use of secondary data available from or through an HIE for the systematic investigation, including research development, testing, preparation, and evaluation, designed to develop or contribute to generalizable knowledge as defined in 45 CFR §164.501 and 45 CFR §46.102, including the use of de-identified data and limited data sets. (74) “Secondary use of HIE data” or “secondary use” means any use or disclosure of data accessed, used or disclosed through an HIE that is not a primary use. Examples of secondary use include, but are not limited to, use of HIE data for conducting research, improving patient safety, marketing, or the sale of HIE data. (75) “Secretary” means the Secretary of Health. (76) “Sensitive health information” means a subset of PHI, which consists of: (a) Part 2 information; (b) Legally protected health information; or (c) Any other information that has specific legal protections in addition to those required under HIPAA or the Maryland Confidentiality of Medical Records Act. (77) “State-designated HIE” means an HIE designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland. (78) “State health improvement program” means a State initiative designed to enhance public health through strategic planning, targeted interventions, and collaboration with stakeholders and the federal government, including State efforts in support of the Total Cost of Care model and successor models agreed to by the federal government and the State. (79) “Submit”, when used in reference to consumer-submitted data, means providing a method by which the health care consumer can electronically upload information to the HIE to then be made available to authorized users of the HIE. (80) “System administrator” means an individual employee within a participating organization (or an individual employed by a contractor to the participating organization) who is designated by the participating organization to manage the user accounts of specified individuals within the participating organization in coordination with an HIE. (81) “Third party system” means hardware or software provided by an external entity to a participating organization, which interoperates with an HIE to allow an authorized user access to information through the HIE and may include an electronic health record system. (82) “21st Century Cures Act” means the 21st Century Cures Act, P.L. 114-255, as amended, and the pertinent regulations at 45 CFR Parts 156, 170, and 171 and 42 CFR Parts 422, 431, 438, 457, 482, and 485. (83) “Unusual finding” means an irregularity in the manner in which use, access, maintenance, disclosure, or modification of health information or sensitive health information transmitted to or through an HIE should occur that could give rise to a breach, a violation under this chapter or a violation of other applicable privacy or security laws. (84) “Use” has the meaning provided in 45 CFR §160.103. (85) “User accounts” mean the records associated with an authorized user's credentials and activities with an HIE or a third party system. #### Regulation .03 Rights of a Health Care Consumer Concerning Information Accessed, Used, or Disclosed Through an HIE. *COMAR 10.25.18.03* A. A health care consumer has the following rights in accordance with the requirements specified in this section: (1) The right to have information regarding the health care consumer's rights under these regulations readily available to assist the health care consumer in making an informed decision concerning: (a) The accessibility of a patient's protected health information electronically through an HIE; and (b) The risks and benefits of participating in the HIE. (2) The right to opt out of an HIE. (a) A health care consumer has the right to opt out of an HIE at any time and refuse access to the patient's PHI through an HIE, except when a disclosure is limited to: (i) Core elements of the MPI; (ii) A disclosure that a person is required to make under federal or State law requirements; (iii) Results of a diagnostic procedure sent to the health care provider who ordered the procedure or another provider as designated by the ordering provider as part of the care delivery of a patient; (iv) Information regarding prescription medications dispensed or filled by a pharmacy, sent to the health care provider who ordered the prescriptions or another health care provider as designated by the ordering health care provider; (v) Public health authorities for reporting purposes required, authorized, or otherwise compliant with applicable law; or (vi) Communications permitted under HIPAA or State law without a health care consumer's consent or authorization when using point-to-point. (b) Provided, however, that §A(2)(a)(iii), (iv), and (vi) of this regulation shall not apply to disclosures of sensitive health information, which receive additional protections consistent with Regulation .04 of this chapter. (c) A health care consumer shall be advised in writing by the HIE receiving the opt-out notice or request that opting out does not preclude any participating organization that has received or accessed PHI via the HIE prior to such opt-out, and incorporated such PHI into its records, from retaining such information in its records. (3) An HIE shall make a good faith effort to facilitate a health care consumer's amendment of the patient's health information available through the HIE by informing the health care consumer how to seek amendment of the information. (a) An HIE shall send information regarding the process for amending health information being made available through the HIE within 20 days of receiving notice from a health care consumer of a desire to amend the patient's health information available through the HIE and shall include the contact information of relevant participating organizations that provided the information; and (b) This process shall be in accordance with the requirements specified in Health-General Article, §4-304(b), Annotated Code of Maryland and HIPAA, including 45 CFR §164.526. (c) An HIE shall make a good faith effort to notify the participating organization of each authorized user who has accessed, used, or disclosed the health information that has subsequently been amended. (4) The right to resume participation in an HIE after previously opting out in accordance with these regulations. Any such resumption of participation shall be upon written notice or request by the health care consumer. B. An HIE shall provide needed information about the HIE to a health care consumer whose protected health information is maintained by a health information exchange, or may be accessed, used, or disclosed through the HIE. (1) An HIE shall develop, adopt, implement, and keep current a health care consumer education plan that considers stakeholder input. (a) The health care consumer education plan shall include the core HIE education content as defined in Regulation .02 of this chapter. (b) The health care consumer education plan shall outline how the HIE will make available the following information to health care consumers: (i) A description of each type of patient health information that may be used, accessed or disclosed through the HIE; (ii) The health information maintained by the HIE; (iii) The specific details concerning who may access, use, or disclose a patient's health information and for what purpose; (iv) The privacy and security measures that the HIE has implemented to protect health information, and a detailed explanation of what happens if there is a breach that results in unauthorized access to protected health information; (v) A health care consumer's rights regarding the HIE and the control over, protection of, use of, and correction of each type of health information; (vi) The process provided for a health care consumer to exercise the health care consumer's rights, including a detailed description of the steps a health care consumer needs to take in order to opt out from participation in the HIE; (vii) The implications of a health care consumer's decision to opt out of participation in an HIE and not permit the disclosure of that consumer's PHI to authorized users, except as otherwise permitted under applicable law; and (viii) The HIE's policies and procedures, including without limitation, policies and procedures consistent with these regulations regarding how the health care consumer may gain access to the patient's health information. (2) An HIE shall develop and implement health care consumer education materials as provided in §B(1) of this regulation. Such education materials shall have the following characteristics: (a) Provide a balanced perspective, outlining the various points of view concerning each subject matter, including the risks and benefits associated with sharing protected health information electronically through the HIE; (b) Are not inaccurate or misleading; (c) Minimize the use of technical terms and, when such terms are necessary, clearly define the technical terms; (d) Use plain language that is easily understandable to each health care consumer population served, taking into account the various levels of education, understanding, and interest across that population; (e) Use text and illustrations that are culturally sensitive, language appropriate, and that recognize user diversity including ethnicity, age, race, and gender; (f) Update material to include and incorporate new information; and (g) Specify the time sensitivity of any material included. (3) An HIE shall cooperate with applicable State agencies to educate health care consumers consistent with a statewide education plan approved by such applicable State agency. (4) An HIE shall make health care consumer educational materials readily available, at no charge, to participating organizations and the participating organizations’ users through distribution channels such as websites, postal mail, email, secure third-party smart phone applications, and any other reasonable media or distribution channel commonly used and generally available to the HIE and health care consumer. (5) In addition to the foregoing requirements, with regard to sensitive health information, the health care consumer educational content shall include: (a) The scope of sensitive health information; (b) The health care consumer’s right to control sensitive health information; (c) The method by which to engage in the granular patient consent process; (d) The method or methods by which the health care consumer can access the patient’s own sensitive health information; (e) The circumstances under which an HIE must restrict or may disclose legally protected health information; and (f) The method by which a health care consumer can request that a patient’s legally protected health information be disclosed to a specific health care provider. (6) When an HIE updates its health care consumer educational content, the HIE shall timely make the updated materials available to health care consumers. C. An HIE shall comply with the following requirements to allow a health care consumer to obtain information concerning a patient's PHI that may be available through the HIE. (1) An HIE shall provide the following information to the health care consumer, upon written notice or request by the health care consumer, describing what PHI is available through the HIE concerning the specified patient: (a) The participating organization that disclosed the PHI to the HIE; (b) The date the PHI was disclosed to the HIE; and (c) The type of PHI disclosed to the HIE, if known by the HIE. (2) An HIE shall provide written information, in accordance with this Regulation, to health care consumers concerning the methods available to such health care consumers to access a patient's PHI that is available through the HIE. (a) If the patient's PHI is directly available electronically to the health care consumer through the HIE, the HIE shall advise the health care consumer how to obtain the PHI electronically. (b) If the patient's PHI is not directly available electronically to the health care consumer through the HIE, the HIE shall, within 7 days from receipt of such health care consumer's written notice or request, provide the health care consumer with the contact information for each participating organization that has disclosed information to the HIE and received information from the HIE concerning the patient, so that the health care consumer may gain access to the patient's health information directly from each participating organization. (3) An HIE shall make a good faith effort to facilitate a health care consumer's amendment of the patient's health information available through the HIE by informing the health care consumer how to seek amendment of the information. (a) An HIE shall send information regarding the process for amending health information being made available through the HIE within 20 days of receiving notice from a health care consumer of a desire to amend the patient's health information available through the HIE and shall include the contact information of relevant participating organizations that provided the information; and (b) This process shall be in accordance with the requirements specified in Health-General Article, §4-304(b), Annotated Code of Maryland and HIPAA, including 45 CFR §164.526. (c) An HIE shall make a good faith effort to notify the participating organization of each authorized user who has accessed, used, or disclosed the health information that has subsequently been amended. (4) Upon receipt of written notice or request, an HIE shall provide each health care consumer with a report detailing any disclosure through the HIE for a time period specified by the health care consumer, of the patient's PHI. In the case of recurring disclosures to the same entity for the same purpose, a summary report may be provided by the HIE. However, if the health care consumer requests the details of the summary report, the HIE shall promptly provide them. (a) The time period specified by the health care consumer shall not exceed the data retention period as specified in the HIPAA Privacy Rule, 45 CFR §164.528. (b) The report shall specify the following for each instance that the patient's PHI was disclosed during the time frame reflected in the report: (i) The name of each authorized user; (ii) The name of the participating organization to which the authorized user is affiliated, if such information is kept by the HIE in the ordinary course of business; (iii) The date and time of the disclosure; (iv) The type of PHI disclosed, if known by the HIE; and (v) The name of the participating organization that made the protected health information available to the HIE. (c) An HIE shall acknowledge a health care consumer's written notice or request for the report within 10 business days of receipt of the request. (d) An HIE shall respond to a health care consumer's written notice or request with either the requested report or with a written explanation why such report is unavailable, when it will be available, or where the health care consumer may obtain the requested information, in accordance with 45 CFR §164.528(a)(2)(D)(3). The HIE shall respond within a reasonable time frame, but not later than 30 days of the initial written notice or request by the health care consumer. (i) An HIE shall provide up to two copies annually of the report at no cost to the health care consumer, upon written notice or request by the consumer. If the report is available in an electronic format, it shall be provided to the consumer in a generally available electronic format such as PDF, if so requested, at no additional charge. (ii) For any additional report, the HIE may charge a reasonable fee not to exceed the cost to provide the additional report, but no more than the allowable amount in accordance with Health-General Article, §4-304, Annotated Code of Maryland, and 45 CFR §164.524(c)(4). D. Consent Management Application. (1) The State-designated HIE shall implement a consent management application that: (a) Allows a person in interest to opt out of or opt in to having a patient’s electronic health information shared or disclosed by an HIE; (b) Allows a person in interest to view the interested patient’s opt-out status. (c) Informs the person in interest of the types of electronic health information that may be shared or disclosed by the State-designated HIE in accordance with §A(2)(a) of this regulation notwithstanding the choice to opt out;; (d) Enables HIEs to readily identify information as to whether a person in interest has opted out of sharing the patient’s electronic health information; and (e) At least includes: (i) Personal identifiers consisting of the full name, date of birth, mailing address, telephone number, medical record number, and other unique identifiers of the patient and person in interest, if not the patient; (ii) The person in interest’s communication contact preferences; (iii) The relationship of the person in interest to the patient; and (iv) The date the patient’s consent preferences were last updated. (2) Within 12 months of the effective date of this regulation, the State-designated HIE shall make the consent management application it develops available to registered HIEs. (3) The State-designated HIE shall implement the consent management application with a secure electronic interface that supports standardized interoperability between various recipient HIE systems. (4) HIE Connection to the Consent Management Application. (a) Exception. Section D(4)(b) of this regulation does not apply to an HIE that solely exchanges electronic health information with other HIEs and does not have any health care providers as a participating organization. (b) An HIE shall: (i) Establish bi-directional connectivity with the consent management application within 12 months of receiving notification from the State-designated HIE that the application is operational; (ii) Update the HIE's system with the most recent version of the consent management application data at least every 5 business days; (iii) Update the consent management application with any opt-out or opt-in requests it has received from an HIE or directly from a person in interest within 5 business days; (iv) Withhold sharing or disclosure of the electronic health information of a patient to the extent the consent management application indicates that the patient has opted out of having electronic health information shared or disclosed by an HIE, except to the extent permitted by §A(2) of this regulation; and (v) Electronically notify authorized users when a patient has restricted data sharing. (5) An HIE shall implement the consent management application in a manner that is consistent with this chapter, its existing policies and procedures regarding use and disclosure of PHI and other personal identifiable information, and its technological capabilities. (6) An HIE shall place a link on its website directing a person in interest to the State-designated HIE’s website to globally opt out or opt in to having a patient’s electronic health information shared or disclosed by an HIE. (7) An HIE shall continue to accept opt-out and opt-in requests from health care consumers directly. (8) The State-designated HIE shall promptly notify the Commission and all HIEs any time the consumer management application is not operational and when services are resumed. (9) An HIE is not required to comply with §D(4)(b) of this regulation when: (a) An emergency exists and all requirements under Regulation .11 of this chapter have been met; or (b) The consent management application is not operational. (10) Section D of this regulation shall be in addition to any restrictions on the disclosure of sensitive health information, consistent with Regulation .04 of this chapter. E. An HIE shall: (1) Establish and maintain an online process that allows health care consumers to obtain an electronic report detailing any disclosures of their information through the HIE in accordance with §C(4)(b) of this regulation; and (2) Implement and maintain compliance with the provisions detailed in Regulation .12A(1)(7), B(1)(2), and C(4)(b)(d) of this chapter in implementing §E(1) of this regulation. F. An HIE shall take affirmative steps to protect a patient's protected health information, including sensitive health information, that is accessible to or through the HIE from a breach or a non-HIPAA violation. (1) An HIE shall have an easily accessible and convenient method by which a person may notify the HIE concerning a potential or an actual breach or a non-HIPAA violation. (2) When an HIE is notified in writing of a potential or an actual breach or a non-HIPAA violation, the HIE shall: (a) Acknowledge receipt of the notification within 1 business day; (b) Begin an investigation concerning the matter upon receipt of the notification in compliance with Regulation .07 of this chapter and; (c) In accordance with Regulation .08 of this chapter, provide the person filing the notification and each health care consumer whose protected health information was breached with information concerning the determination and resolution of the matter by the HIE. (3) An HIE shall implement robust technical measures consistent with generally accepted industry best practices to assure valid patient identification and minimize patient record mismatches. G. An HIE shall implement a process to allow a health care consumer to make an educated decision regarding the patient's participation in an HIE, opting out from such participation, or opting to resume participation in the HIE system, in accordance with this regulation. (1) An HIE shall maintain a log that records each patient's participation status over time; and (a) The HIE shall retain the log for the duration required by State or federal law, whichever requires a longer retention; and (b) The HIE shall keep the log in a retrievable storage medium. (2) An HIE may not disclose a patient's PHI if the health care consumer has submitted a written notice or request to opt out of the HIE in accordance with §(A)(2) of this regulation except as otherwise permitted under applicable law and in accordance with this chapter. (3) An HIE may not disclose information derived from a patient's PHI, including for secondary use, if the health care consumer has submitted a written notice or request to opt-out of the HIE, except as otherwise permitted under applicable law. (4) An HIE may not unreasonably deny a health care consumer’s expressed preferences. H. The following requirements shall apply to all communications between an HIE and a health care consumer: (1) An HIE shall implement a process to allow a health care consumer to communicate with the HIE about the patient's participation status through an appropriate medium of the health care consumer's choice, including the following: (a) By telephone, via a toll-free number; (b) By mail, via a standardized form; (c) By fax, via a standardized form; (d) Online, via a secure website; and (e) In person at the HIE's offices during business hours. (2) A health care consumer’s communication opting out or opting in to an HIE shall be made: (a) In writing; (b) Online; or (c) By telephone, if the HIE confirms the action with a written communication to the health care consumer in accordance with §H(5)(a) and (b) of this regulation. (3) An HIE shall take appropriate measures to assure that a health care consumer who communicates with the HIE is authorized to act on behalf of the patient. (4) An HIE shall implement the health care consumer's requested action within 5 business days of receipt of the health care consumer's written or online request concerning: (a) Opting out of the HIE; and (b) Resuming participation in the HIE after previously opting out. (5) An HIE shall provide to each health care consumer the option to receive confirmation of any change in the patient's participation status. If a health care consumer requests such confirmation in writing, the HIE shall: (a) Send the confirmation of participation status change within 3 business days of the effective date of change of such patient's participation status; and (b) If consistent with all applicable privacy and security law and regulations, including HIPAA and applicable State law and regulations, send the confirmation of status change through one of the following methods as specified by the health care consumer: (i) An email sent to the email address specified by the health care consumer; (ii) A letter to an address specified by the health care consumer; (iii) A letter by fax to a fax number specified by the health care consumer; (iv) A letter given to the health care consumer at the HIE during normal business hours; or (v) A text message sent to the number specified by the health care consumer. (6) When a health care consumer changes the patient's participation status, the HIE shall provide the following to the health care consumer and, unless the patient is a minor or subject to a power of attorney or otherwise unable to handle his or her own affairs, to the patient: (a) Information concerning when the status change will become effective; and (b) Information concerning what information will be excluded from the HIE regarding a health care consumer who opts out. I. A participating organization shall comply with the following requirements to assure patient and health care consumer rights. (1) A participating organization shall inform each health care consumer no later than the first medical encounter following enrollment of the organization in an HIE, by written and oral notice, of: (a) Such organization's participation in an HIE, including in such organization's Notice of Privacy Practices under HIPAA; and (b) Information concerning the health care consumer's right to opt out from participation in the HIE and the process to opt out; and (c) The types of information the participating organization will disclose to the HIE and for what purposes information accessed through the HIE may be used for treatment, payment, health care operations, and secondary use as described in this chapter. (2) In addition to applicable HIPAA notification requirements, a participating organization shall notify each health care consumer whose protected health information, including sensitive health information, is breached or is maintained, accessed, used, or disclosed in a manner that constitutes a non-HIPAA violation in accordance with Regulation .08 of this chapter. #### Regulation .04 Access, Use, or Disclosure of Sensitive Health Information. *COMAR 10.25.18.04* A. Consistency with Disclosure Requirements Under Federal and State Law. (1) A person shall comply with all relevant State and federal laws, including 42 CFR Part 2, and Health-General Article, §4-302.5, Annotated Code of Maryland, concerning the access, use, or disclosure of sensitive health information through an HIE and maintenance of such information by an HIE. (2) If federal or State law requires written consent or authorization for access, use, or disclosure of sensitive health information, a person shall obtain consent or authorization consistent with the applicable law prior to the access, use, or disclosure of sensitive health information to and through an HIE to an authorized recipient. (3) If federal or State law does not require written consent or authorization for access, use, or disclosure of sensitive health information, a person may not require consent or authorization prior to the access, use, or disclosure of the sensitive health information through an HIE. (4) An HIE shall use only point-to-point transmission to allow access, use, or disclosure of the sensitive health information through an HIE, unless the HIE implements: (a) Nationally recognized standards that support control by the health care consumer over the electronic exchange of the patient's sensitive health information consistent with the privacy and consent directives made by the health care consumer; (b) Electronic exchange controls and processes that: (i) Support granular patient consent for the electronic transmission of sensitive health information consistent with applicable State and federal laws concerning the access, use, or disclosure of sensitive health information, including applicable standards and technical requirements in accordance with Part 2; and (ii) Assure that the health care consumer's granular consent controls remain associated with the sensitive health information and are adhered to as the information is transmitted through, maintained, or disclosed by the HIE; and (c) Health care consumer educational content: (i) That is developed and established in coordination with the Commission and stakeholders; (ii) That is kept current; and (iii) The receipt of which shall be acknowledged by the health care consumer as part of the granular consent process. (5) In the case of the improper access, use, maintenance, or disclosure of sensitive health information, including an inadvertent release through an HIE, a participating organization shall take the following actions in addition to any other requirement imposed under federal or State law: (a) Take all steps necessary to immediately stop any further improper access, use, disclosure, or release of the patient's sensitive health information through the HIE and the improper maintenance of such information by the HIE; and (b) In accordance with Regulation .08 of this chapter, notify each health care consumer whose sensitive health information has been accessed, used, maintained, or disclosed in violation of applicable State or federal laws, including a non-HIPAA violation. B. Procedure for Disclosing or Re-disclosing of Part 2 Health Information. (1) An HIE shall be in compliance with Part 2 (2) A participating organization that is a Part 2 program, as that term is defined by Part 2, shall identify itself as such and clearly indicate with all of its patient records any limits on use or disclosure required by Part 2. (3) An HIE or participating organization that receives Part 2 information may not re-disclose such information without appropriate patient consent or authorization except as permitted by applicable federal and State laws and regulations. C. Procedures for Disclosing or Re-Disclosing Legally Protected Health Information. (1) An HIE shall be in compliance with Health-General Article, §4-302.5, Annotated Code of Maryland, and COMAR 10.11.08. (2) By January 8, 2024, an HIE shall submit to the Commission: (a) An affirmation that it: (i) Possesses the technological capability to filter and restrict from disclosure legally protected health information to the extent required by law; (ii) Is parsing restricted codes and conveying all other information in the health record that is not prohibited by law to exchange; and (iii) Possesses the technological capacity to allow a consumer to request and consent to the exchange of legally protected health information to a specific treating provider; or (b) An implementation plan that includes: (i) An affirmation that, despite its best efforts, the HIE lacks the technological capability to fully comply with §C(1) of this regulation as of January 8, 2024, including a detailed explanation of the HIE’s limitations; (ii) A detailed description of the steps the HIE is taking to ensure compliance with §C(1) of this regulation by June 1, 2024; (iii) A timeline to implement the requirements of Health-General Article §4-302.5, Annotated Code of Maryland, by June 1, 2024; and (iv) A description of the extent legally protected health information and other health information will be restricted through the HIE during the implementation of its plan. (3) If an HIE submits an implementation plan in accordance with §C(2)(b) of this regulation, the HIE shall: (a) Notify all participating organizations by January 8, 2024, that the HIE is unable to comply with §C(1) of this regulation with a written notice that describes the extent legally protected health information and other health information will be restricted through the HIE during the implementation of its plan; (b) Provide a status report to the Commission by April 1, 2024, detailing the progress the HIE has made under its implementation plan; and (c) Submit validation to the Commission by June 1, 2024, that it possesses the technological capability to filter and restrict from disclosure legally protected health information to the extent required by law. (4) The Commission shall consider an HIE’s implementation plan and reported progress when assessing penalties for a violation of this section. #### Regulation .05 Requirements for Accessing, Using, or Disclosing Health Information Through an HIE. *COMAR 10.25.18.05* A. As a requirement of participation in an HIE, the HIE shall require each participating organization to enter into a binding participation agreement that: (1) Requires the participating organization and each authorized user to comply with this chapter; (2) Requires the participating organization and each authorized user to comply with all applicable federal and State privacy and security laws; and (3) Includes a business associate agreement: (a) In compliance with 45 CFR §164.504; and (b) If the participating organization will maintain Part 2 information, the business associate agreement shall comply with the additional requirements that apply to a qualified service organization under 42 C.F.R. §2.11. (4) Permits PHI disclosed through the HIE to the authorized user of a participating organization to be incorporated into the patient’s medical record kept by such participating organization, and requires compliance with all applicable federal and State laws. B. An HIE shall only disclose PHI through an HIE for a primary use consistent with the following: (1) The disclosure shall be only to an authorized user for the specific purpose for which that authorized user is given access to the PHI; and (2) All disclosures shall be in full compliance with these regulations. C. The Commission may suspend the registration, in accordance with Regulation .09 of this chapter, of a registered HIE that inappropriately discloses to any person any PHI, or health information derived from PHI, that is available through the HIE’s infrastructure, except as consistent with or otherwise permitted by this chapter and applicable federal or State law. D. To assure that only an authorized user accesses, uses, or discloses PHI through or from an HIE, an HIE shall: (1) Develop and maintain an HIE access matrix that includes the defined HIE access levels available to each authorized user. (a) The HIE access matrix shall be used for the following purposes: (i) To assign an HIE access level to each staff member of the HIE or its contractor that allows only the minimum necessary access to PHI to perform that staff member’s authorized purpose; and (ii) To assist each participating organization and its system administrator in assigning the appropriate HIE access level to each authorized user of that participating organization. (b) The HIE shall review its HIE access matrix annually and revise it as necessary to reflect relevant changes in technology, standards, or law; and (c) The HIE shall have the necessary technological capabilities in its core infrastructure to limit an authorized user’s access to the HIE according to the then currently assigned access level of its access matrix. (2) Provide technical assistance and guidance to the system administrator of each participating organization in assigning the appropriate HIE access level to each of its authorized users; (3) Comply, at a minimum, with the most recent Level 2 requirements set by the National Institute of Standards and Technology (NIST), as set forth in April 2006 in Special Publication 800-63 (Version 1.0.2): Electronic Authentication Guideline for both Registrations and for Registration Record Retention; and (4) Adopt and implement an authentication process that: (a) Requires the authentication of an authorized user at each “log in” prior to allowing that individual access to the HIE; (b) Requires a single factor authentication with two characteristics that include a user name and a password, along with an additional security precaution, which may include a security question or a device registration. (c) Ensures that the data stored in the HIE that is used to authenticate an authorized user is encrypted to the level set by industry best practices; and (5) Accept as valid a third party system’s authentication of an authorized user accessing the HIE through that third party system, as long as such access and third party system: (a) Permits the HIE to audit and monitor the user’s HIE activities; and (b) The HIE has received written assurances from the third party system that it is compliant with these regulations and all applicable federal and State privacy and security regulations. (6) If an HIE learns or has reason to believe that the third party system is not compliant, then it shall immediately cease acceptance of such third party system’s authentication of authorized users until the third party system demonstrates compliance to the reasonable satisfaction of the HIE. E. To assure that only an authorized user accesses, uses, or discloses PHI through or from an HIE, a participating organization shall comply with each of the following. (1) A participating organization shall designate a system administrator who is capable of carrying out the requirements set forth in §F of this regulation on behalf of the participating organization prior to exchanging any PHI through the HIE. (2) A participating organization shall promptly inform its system administrator of any circumstances that require any of the actions described under §F of this regulation; (3) A participating organization shall ensure that any third party system it uses appropriately authenticates an authorized user prior to allowing that individual access to the HIE through the third party system. (a) The third party system shall authenticate an authorized user at each “log in.” (b) The third party system shall ensure that the data stored in the system which is used to authenticate an authorized user is encrypted to the level set by industry best practices. (c) A participating organization shall adopt and implement a protocol to be followed by a third party system that requires a user name, a password, and an additional security precaution which may include a security question or a device registration. (4) A participating organization shall inform the HIE concerning the following: (a) The designation of the system administrator, or any change in such designation, within 5 business days of any such designation or change; (b) A breach or non-HIPAA violation by a person who had or has access to the HIE through the participating organization; or (c) An act or event that it has a reasonable basis to believe is or may be a significant violation of this chapter. F. The system administrator of a participating organization shall carry out each of the following measures on behalf of the participating organization. (1) The system administrator shall identify each authorized user within the participating organization and shall note the individual’s assigned unique user name in accordance with the most recent applicable standards issued by NIST, or other comparable standards generally adopted by the health care and HIE industry. (2) The system administrator and HIE shall coordinate with the Commission to determine a methodology for assigning each authorized user with a unique user name and password and to assure that all HIEs use a commonly accepted protocol to avoid the possibility of duplicate user names and passwords. (3) The system administrator, in coordination with the HIE, shall assign to each authorized user an access level that appropriately corresponds to that individual’s role within the participating organization and the permitted access to PHI available through the HIE on behalf of the participating organization. (4) The system administrator shall modify in a timely manner an authorized user’s access level as appropriate to reflect any change in that individual’s role within the participating organization; and (5) The system administrator shall immediately terminate access through an HIE in accordance with Regulation .07 of this chapter for any authorized user: (a) Who is suspended by the participating organization; (b) Who is no longer associated with the participating organization; or (c) Who no longer requires access to the HIE. (6) The system administrator shall attest to the HIE regarding the appropriateness of a staff member to be an authorized user and that the HIE access level assigned to that staff member corresponds to the authorized user’s role within the participating organization. #### Regulation .06 Auditing Requirements. *COMAR 10.25.18.06* A. In order to ensure that only an authorized user who is appropriately authenticated is granted access to HIE information, an HIE shall: (1) Develop and implement protocols, methodologies, and a monitoring approach designed to discover any unusual finding, which may be identified within an audit of the user access logs, including conducting ongoing electronic monitoring of user access logs and investigate any unusual findings in accordance with this chapter; (2) Conduct each audit under this regulation in accordance with best practices using industry accepted standards and methodologies; (3) Conduct random audits of the user access logs to identify any unusual finding; and, if the HIE has been notified about an unusual finding or has reason to believe that inappropriate access has occurred, conduct random audits at least every other week until the unusual finding or inappropriate access has been mitigated; (4) At least quarterly, conduct random audits of security measures and any other forms of data security in place to determine if they are still sufficient and compliant with applicable standards; (5) Investigate each unusual finding identified in the access log audit to determine if there has been a violation of Regulation .05 of this chapter; (6) Resolve an unusual finding by: (a) Taking actions necessary to correct each identified technical control deficiency; or (b) Taking remedial action under Regulation .07 of this chapter; (7) Report any unusual finding to each participating organization involved in the unusual finding, as follows: (a) If the unusual finding involves fewer than 10 patients, within 5 business days after the unusual finding is discovered; (b) If the unusual finding involves between 10 and 50 patients, within 2 business days after the unusual finding is discovered; and (c) If the unusual finding involves more than 50 patients, within 1 business day after the unusual finding is discovered; and (8) Maintain an audit trail of user access logs in a retrievable storage medium, as follows: (a) The HIE shall perform periodic testing to ensure that the storage medium being used will allow the data to be recovered. (b) The HIE shall perform periodic testing and implement upgrades and updates to ensure that the storage medium is secure and has not been improperly accessed. (c) The data shall be kept for the longest duration of time identified in applicable State and federal requirements. B. When an HIE has identified a potential breach or non-HIPAA violation, the HIE shall conduct an unscheduled audit within 30 days that: (1) Gathers relevant information to determine if there is a violation; (2) Reflects the size and scope of the potential violation; and (3) Complies with Regulation .08 of this chapter. C. An HIE shall at least annually enlist a qualified independent auditing firm to audit its privacy, security, and legal compliance in accordance with the following provisions: (1) The audit shall: (a) Assess potential risks to protect the confidentiality, integrity, and security of PHI; (b) Assess operational compliance with State and federal law, including the requirements of this chapter; (c) Be designed to determine the adequacy of business and technology-related controls, policies, and procedures and other safeguards employed by third-party service organizations based on industry standards and best practices; and (d) Include an assessment of cybersecurity posture and compliance with this chapter, applicable provisions in HIPAA and HITECH, and recognized security practices by way of accreditation or certification from a nationally recognized entity. (2) An HIE shall develop auditing policies and procedures for the independent auditor to conduct such an audit, which shall include, at a minimum: (a) The scope of the audit; (b) A description of all third-party organizations and processes to review and assess related privacy and security controls and audit reports; (c) Interviews with relevant staff, including those from third-party service organizations, as appropriate; (d) Names and contact information of all persons responsible for reviewing and maintaining privacy and security to include the implementation of corrective actions to address apparent gaps; and (e) Time frames for completing audits and related activities. (3) An HIE shall provide the audit findings to the Commission in accordance with Regulation .09 of this chapter. (4) If an audit detects unusual findings, an HIE shall investigate and resolve the matter in accordance with this regulation. D. Upon the request of the Commission and consistent with the specifications in such request, an HIE shall: (1) Provide a summary of the results of any audit that is required by this chapter, and any corrective action plans identified by the audit, to the Commission; and (2) Conduct an additional unscheduled audit within 180 days of the request and provide the results of such an audit to the Commission within the time frame specified by the Commission. E. If an HIE’s audit reveals information that demonstrates a pattern of inappropriate access, use, maintenance, or disclosure of information that constitutes a breach or non-HIPAA violation, or if the health information of more than ten patients was improperly used, accessed, maintained, or disclosed during the 12 months prior to the audit, then: (1) The HIE shall use the findings from the audit to: (a) Educate and train all impacted persons, which may include its workforce, participating organizations, and authorized users on proper access, use, and disclosure of information through or from the HIE; and (b) Evaluate and implement new control measures, including policies, procedures, or technology, to ensure proper use and access of the HIE; and (2) The HIE shall take the appropriate measures specified in Regulation .07 of this chapter. F. If an HIE’s audit reveals information that demonstrates a pattern of noncompliance with State and federal law, then: (1) The HIE shall use the findings from the audit to: (a) Educate and train all impacted persons, which may include its workforce, participating organizations, and authorized users on proper access, use, and disclosure of information through or from the HIE; and (b) Evaluate and implement new control measures, including policies, procedures, or technology, to ensure compliance; and (2) The HIE shall take the appropriate measures specified in the Regulation. 07 of this chapter. G. An HIE and its participating organizations shall adopt an access and auditing plan that requires the HIE and each participating organization, as applicable, to conduct a random audit of the HIE access logs on a monthly basis. (1) The random audit included in the plan shall be assigned to the HIE or the participating organizations according to their respective system's technological capabilities. (2) The access and auditing plan shall include: (a) The manner used to identify a non-HIPAA violation of this chapter or a breach; (b) The method to be used to report a non-HIPAA violation of this chapter or a breach; (c) The reasonable steps that will be taken to promptly mitigate a non-HIPAA violation of this chapter or a breach; and (d) A review of access logs to ensure that only an authorized user who is appropriately authenticated is granted access to HIE information through a participating organization's third party system. (3) If a participating organization does not conduct its own audit, it shall review the HIE access logs relating to the participating organization within 10 days of receipt from the HIE. An HIE shall send HIE access logs to each participating organization no less than quarterly. (a) The purpose of the review is to: (i) Detect patterns of inappropriate access, use, maintenance, or disclosure; and (ii) Compare the PHI accessed by the authorized user with the health care provided to assure that the authorized user's use of the HIE is appropriate. (b) In order to conduct the quarterly review, the HIE shall provide a participating organization with audit record information concerning the participating organization's authorized users access of the HIE that shall include: (i) The name and access level of each user; (ii) The name of the patient whose PHI was accessed; (iii) The date and time of access; and (iv) The type of PHI that was accessed. #### Regulation .07 Remedial Actions to Be Taken by an HIE. *COMAR 10.25.18.07* A. An HIE shall immediately suspend a person's access to the HIE when it is necessary to avoid serious harm to the privacy or security of health information accessed, used, or disclosed through or from the HIE. (1) An HIE may, in its sole discretion, suspend a person's access to the HIE pursuant to this section before an investigation under Regulation .07B of this chapter is completed. In addition, if the HIE determines that serious harm to the privacy or security of health information or an ongoing risk of improper use, access, maintenance, or disclosure of PHI may occur prior to conclusion of an investigation, it shall suspend a person’s access to the HIE pursuant to this section before an investigation is complete. (2) Such suspension shall continue until the underlying threat to the privacy or security of health information is contained. B. An HIE shall conduct an investigation if there is reason to believe that a breach or non-HIPAA violation has occurred. (1) The HIE shall begin the investigation upon learning of the allegations giving rise to a potential breach or violation. (2) The HIE shall conduct the investigation in a thorough, timely, professional manner and take all necessary actions to gather information concerning the potential breach or violation that reflects the size and scope of such potential breach or violation. (3) If appropriate, an investigation shall include an audit under Regulation .06 of this chapter. (4) Upon the completion of an investigation, which shall not exceed 14 business days, an HIE shall: (a) Make a written finding describing the results of an investigation and provide a copy to the Commission; and (b) Maintain records of each investigation (audits, complaints, breaches, non-HIPAA violations) for at least 5 years from the date of completion of such investigation or 5 years from the date a minor patient becomes an adult, whichever is longer. C. If an HIE has a reasonable belief that a breach or non-HIPAA violation has occurred, either as a result of an investigation or otherwise, the HIE shall: (1) For a breach, follow Regulation .08 of this chapter and federal breach notification requirements and timelines; (2) For non-HIPAA violations, submit a corrective action plan to the Commission within 10 business days of conclusion of its investigation, which shall include: (a) Any remedial action necessary to address the breach or violation as soon as practicable; (b) Any steps necessary to correct the underlying problem, such as a change in processes or procedures, new technology, and training; and (c) An appropriate and reasonable time frame for implementing the remedial action; (3) Within a reasonable time frame, but in no event more than 10 business days following the investigation, provide the following to the Commission, and to the participating organizations: (a) A copy of the findings of the investigation, excluding any PHI or sensitive health information; (b) Each remedial action to be taken by each person and the associated time frame of the remedial action; (c) Any action necessary to mitigate the harm that may be caused by the breach or the non-HIPAA violation; (d) The identity of the person that is responsible for carrying out each action to mitigate harm; and (e) Any future action that the HIE may take, including suspension of access or progressive discipline, if a person does not comply with the remedial action; (4) Immediately suspend access of a person when one of the following occurs: (a) Available information demonstrates a significant breach by the person; (b) Available information demonstrates a significant non-HIPAA violation by the person; (c) Available information demonstrates a violation of State or federal law relevant to privacy or security by the person; (d) The person has sold health information accessed through the HIE in violation of these regulations; (e) The person has failed to carry out the remedial actions identified by the HIE; or (f) The Commission issues a request for suspension of the person as provided in Regulation .09 of this chapter; and (5) Notify the health care consumer pursuant to Regulation .08 of this chapter, if such notification is required under applicable law, including HIPAA, or if so directed by the Commission. D. After verifying that each remedial action is complete, an HIE may reinstate a person's authorization to access information through the HIE provided that: (1) The Commission has not revoked the person's access to the HIE as provided in Regulation .09 of this chapter; and (2) The HIE modifies the person's access as needed to ensure compliance with this chapter. E. A person may file a written notice or request with the Commission that the Commission review an HIEs action under Regulation .07 of this chapter when the person has reason to believe that the HIE has acted inappropriately. (1) A request for review shall be filed within 30 days after the person knew or had reason to know of the HIEs action in question; (2) The request for review shall set forth each reason why the person believes that the HIE's action is inappropriate. (3) The Commission may determine that no investigation is necessary or may take action under Regulation .09C. F. An HIE shall provide notice of each suspension and each reinstatement of a person's authorization to access information through an HIE in the following manner: (1) The HIE shall send an electronic notice to the person who is the subject of the action within 24 hours of the suspension or the reinstatement and to the Commission on a monthly basis. (2) The notice shall include: (a) The name of the person who is the subject of the action; (b) The name of any affected participating organization; (c) The basis for the suspension or reinstatement; and (d) The effective date of the suspension or reinstatement. (3) The notice shall not include PHI. (4) The notice shall not be considered confidential. #### Regulation .08 Notice of Breach and non-HIPAA Violation. *COMAR 10.25.18.08* A. Notification of a breach shall be required consistent with notification requirements of applicable federal and State laws, including HIPAA and the HITECH Act. B. When federal or State law does not require an HIE or other entity to provide notification to a participating organization or to an effected health care consumer, or when Part 2 does not mandate other notification requirements, the HIE shall provide notification of breach and, if applicable, non-HIPAA violations pursuant to this chapter. (1) If the investigation under Regulation .07 of this chapter concluded that there was a breach or non-HIPAA violation, in addition to applicable HIPAA notification requirements, the HIE shall notify: (a) The person who notified the HIE of the potential breach or non-HIPAA violation, if applicable, and to the extent permitted by HIPAA and other federal and State privacy laws; (b) Any participating organization that has provided health information regarding the health care consumer involved; and (c) Each patient or person in interest acting on behalf of each patient whose PHI or sensitive health information was inappropriately accessed or disclosed due to a breach or non-HIPAA violation. (2) In addition to other requirements specified in this section, the HIE shall include in its notification, the contact information for the HIE, including the address and toll-free telephone number where the health care consumer can learn more information. C. Notification to a Health Care Consumer. (1) If the entity providing the notification under this Regulation has knowledge that another person is acting as the health care consumer for the patient, the entity shall provide the notification to that person instead of the patient. (2) A notification to the health care consumer required under this Regulation shall be: (a) In writing by first-class mail to the health care consumer, at the last known address of the health care consumer, if no prior election as to notice has been made; or (b) As specified as a preference by the health care consumer under Regulation .03H of this chapter. (3) If there is insufficient or out-of-date contact information that precludes notice consistent with this chapter, a substitute form of notice shall be provided. A substitute form of notice may include publishing the notice on the home page of the entity's website to the extent permitted by HIPAA and other federal and State privacy laws. (4) When notice about a breach or non-HIPAA violation is required pursuant to this chapter, a participating organization or an HIE, as required, shall notify a health care consumer in writing within a reasonable time frame, but not later than 60 days from the discovery of the breach or from the date that the HIE should have reasonably discovered the breach. (5) The written notification shall include: (a) A description of the breach or non-HIPAA violation that occurred and the remedial actions taken by the participating organization, provided that the notification shall not contain any sensitive health information; (b) Information about the patient's right to notify credit reporting agencies of the potential for identity theft or medical identity theft; (c) Contact information for the HIE, including the address and toll-free telephone number where the health care consumer can learn more information; (d) Contact information for at least one credit reporting agency; (e) Information concerning the patient's right to opt out of the HIE; and (f) The toll-free numbers, addresses, and websites for: (i) The Office of the Attorney General, Consumer Protection Division; and (ii) The U.S. Department of Health and Human Services, Office of Civil Rights. (6) If the entity providing the notification keeps a medical record on the patient, the notification shall be placed within the patient's medical record. D. Notification to Appropriate Authorities. (1) Each participating organization and each HIE shall report all violations of federal or State privacy or security law to: (a) Those federal or State authorities to which reporting such violation is required by applicable law, whether or not such laws are specifically set forth in this chapter; and (b) Shall promptly send a copy of such report to the Commission. (2) If the Commission is notified of a breach under this regulation, it shall forward such notification to the Office of the Attorney General, Consumer Protection Division, within 30 days after receipt of the notification. #### Regulation .09 Registration and Enforcement. *COMAR 10.25.18.09* A. To operate an HIE in the State, a person shall be recognized by the Commission as having met requirements for registration. (1) A person shall complete an application for registration in a form and manner specified by the Commission that shall include: (a) The HIE's definition of what constitutes an unusual finding within Regulation .06 of this chapter; (b) The HIE's current audited financial statement that demonstrates the financial viability of the HIE; (c) The identity of the HIE's registered resident agent who shall accept service in Maryland on behalf of the HIE; (d) Documentation showing its technical capabilities, which may include accreditation or candidacy status by a nationally recognized accrediting body; and (e) Provisions for reasonable notice to participating organizations and the Commission if the HIE ceases to operate in Maryland; and (f) Other information as required by the Commission. (2) Financial Integrity. (a) Following review of the financial statement provided by the HIE under §A(1)(b) of this regulation, the Commission may require a bond, letter of guarantee, or other financial instrument from the HIE, its parent company, or other responsible person. (b) The amount of a bond, letter of guarantee, or other financial instrument required under this regulation shall be established by the Commission and be based on an HIE's financial statement. (c) If a bond is required under §A(2)(a) of this regulation, it shall at a minimum: (i) Identify the Commission as the sole beneficiary; (ii) Be continuous and subject to cancellation only after 60 days' notice to the Commission; (iii) Contain the following language or similar language acceptable to the Commission: “Payment under this bond shall be due in the event the Commission determines that the HIE is financially insolvent or unable to meet its obligations as a registered HIE in Maryland”; and (iv) Permit the Commission to direct that the proceeds of the bond be paid or disbursed as necessary to maintain or repair the privacy and security of PHI that was or is available through the HIE. (d) If a bond is required under §A(2)(a) of this regulation, it shall be obtained from a company licensed in the State to write surety types of insurance. (e) If a letter of guarantee or other financial instrument is required under §A(2)(a) of this regulation, the guarantor shall submit a current balance sheet and income statement to the Commission. (3) Within 45 days after receipt of complete information from an applicant seeking to register as an HIE in the State, the Commission shall take one of the following actions: (a) Recognize the HIE as registered in the State; or (b) Deny the registration for reasons enumerated to the applicant. B. The Commission shall annually renew the registration of an HIE registered in the State that demonstrates its continued compliance with this chapter and provides the following information in a form and manner specified by the Commission, within 120 days of the close of its fiscal year: (1) Updated information that reflects each change regarding the items in §A(1) of this regulation; (2) Results of an audit performed in compliance with Regulation .06 of this chapter; (3) As deemed appropriate by the Commission, additional requirements set forth in §A(2) of this regulation; and (4) Other information as requested by the Commission. C. The Commission may take an enforcement action against a person when there is reasonable basis to believe that the person has violated a provision of this chapter. (1) The Commission may conduct any investigation into a potential violation. (a) A person shall cooperate in an investigation conducted by Commission staff into a potential violation. (b) A person shall provide information sought by Commission staff within 10 business days of its request for such information, unless an extension of time is sought for good cause shown and granted by the Commission. (2) After an investigation under §C(1) of this regulation, the Commission staff may issue a notice of proposed action that includes: (a) The details regarding each violation or potential violation; (b) A request for a person to submit a corrective action plan in order to achieve compliance with this chapter, which may include: (i) An action aimed at correcting the underlying issue; and (ii) Any other action that is appropriate under the circumstances. (c) A recommended resolution of the potential violation, which may include: (i) Non-public reprimand; (ii) Public reprimand; or (iii) Limitations on HIE registration or a person's access to information through an HIE; (iv) Suspension of HIE registration or a person’s access to information through an HIE; (v) Revocation of HIE registration or a person’s access to information through an HIE; (vi) Financial penalties in accordance with §C(3) of this regulation; or (vii) Referral to another State or federal agency for civil or criminal enforcement. (3) Civil and Criminal Penalties. (a) Civil Penalties. A person who knowingly fails to comply with this chapter shall be subject to a civil penalty imposed by the Commission not exceeding $10,000 per day based on: (i) The extent of actual or potential public harm caused by the violation; (ii) The cost of the investigation; and (iii) The person’s prior record of compliance. (b) Criminal Penalties. Beginning June 1, 2024, a person who knowingly violates Health-General Article, §4-302.5, Annotated Code of Maryland, shall be guilty of a misdemeanor and on conviction is subject to a fine not to exceed $10,000 per day based on: (i) The extent of actual or potential public harm caused by the violation; (ii) The cost of the investigation; and (iii) The person’s prior record of compliance. (4) When the Commission staff determines that a notice of proposed action is not appropriate given the lack of available evidence or other circumstances, it may issue one of the following: (a) A letter advising that no action is recommended at that time; or (b) A letter finding that no action is warranted. D. A person who receives a notice of proposed action from the Commission staff may request an opportunity to show cause why the proposed action should not be taken. (1) A written request to show cause shall be filed with the Commission and shall comply with the following: (a) It shall be filed within 20 days of the issuance of the notice of proposed action; and (b) It shall include each fact upon which the person relies to show cause why the proposed action should not be taken. (2) Upon receipt of a request to show cause, the Commission staff may meet with the person to attempt to resolve the matter in a manner that protects the public and is in the public interest. (3) If a notice of proposed action is not resolved within 45 days of the filing of a request to show cause, a hearing officer shall be designated by the executive director of the Commission. (a) The hearing officer shall hear evidence as needed; (b) The hearing shall be conducted in accordance with the Maryland Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland, and these regulations. (c) The hearing officer shall issue a recommended decision that contains proposed findings of fact and conclusions of law and may recommend that the Commission take one of the following actions: (i) Adopt the action proposed by Commission staff; (ii) Adopt a proposed action recommended by the hearing officer; or (iii) Find that no action is warranted. E. A request that the Commission not adopt the recommended decision may be made by either Commission staff or a person who is the subject of an enforcement action. (1) Written exceptions to the recommended decision shall be filed within 20 days of receipt of the hearing officer's recommended decision. (2) Exceptions shall specifically identify in writing each finding and conclusion to which exception is taken, citing those portions of the record on which each exception is based. (3) A written response to exceptions to the recommended decision may be filed by an opposing party within 15 days of receipt of exceptions. (4) Each person taking or responding to exceptions may present oral argument to the Commission, not to exceed 10 minutes per party, unless extended by the Chair of the Commission. (5) The decision of the Commission shall be by a majority of the quorum present and voting. F. The Commission may coordinate with the Office of Attorney General concerning any potential violation involving a matter within the Attorney General’s authority pursuant to State or federal law. G. If an HIE has reasonably determined that it is unable to independently meet any requirements of this chapter, then the HIE shall develop and implement policies to ensure the HIE’s compliance through the execution of a written agreement with a participating organization or a business associate that will bring the HIE into compliance with this chapter. Every year as a part of the registration renewal process, the HIE shall submit a written attestation by an independent third-party auditor to the Commission, attesting that the HIE has been in full compliance with the requirements of this chapter for the 12-month period prior to the audit. H. Exemptions. (1) An HIE may request a 1-year exemption from certain requirements of this chapter. (2) An exemption request must: (a) Be in writing; (b) Identify each specific requirement of this chapter from which the HIE is requesting an exemption; (c) Identify the time period of the exemption, if any; (d) State the reason for each exemption request; and (e) Include information that justifies the exemption request. (3) Within 45 days after receipt of complete information from an HIE requesting an exemption, the Commission shall take one of the following actions: (a) Grant the exemption by providing written notification; or (b) Deny the exemption request by providing written notification that enumerates the reasons for the denial to the HIE. (4) An exemption may not be made for any requirement within this chapter that is otherwise required of the HIE by federal or other State law. (5) An exemption may be made on the following grounds: (a) The absence of certain functionality in the infrastructure of the HIE that does not allow the HIE to maintain compliance with the requirement; (b) The requirement would hinder the ability of the HIE to comply with other requirements of this chapter or federal or other State laws; or (c) The requirement would cause an undue burden or hardship on the HIE, such that the HIE would no longer be able to provide HIE services in the State. (6) For good cause shown, the Commission may renew a 1-year exemption for an additional 1-year period. #### Regulation .10 Requirements for Accessing, Using, or Disclosing of Data Through an HIE for Secondary Use. *COMAR 10.25.18.10* A. An HIE may not use or disclose a patient’s sensitive health information for secondary use unless permitted by applicable federal or State laws and regulations. B. Population Health Management. (1) An HIE may disclose de-identified data or a limited data set, as defined at 45 CFR §164.514(e), to a care management organization for purposes related to population health management, if approval is obtained from an internal review committee designated by the care management organization, which has: (a) Entered into a data use agreement with the HIE; and (b) Attested that the request is: (i) For population health management purposes; and (ii) Limited to the minimum necessary to complete the function. (2) An HIE may disclose individually identifiable health information to a care management organization for purposes related to population health management, if: (a) The requirements of §B(1) of this regulation are met; (b) Appropriate notice has been provided to health care consumers whose information is being requested, and either: (i) The health care consumers have authorized the release of their information to the requesting entity; or (ii) An external and independent review committee has waived the need for the requesting entity to obtain authorization from those health care consumers who were provided appropriate notice, in accordance with Regulation .02B(4) of this chapter; and (c) The disclosure is consistent with the authorization. (3) Any external and independent review committee identified by the care management organization may approve an authorization waiver request where the requesting care management organization has demonstrated that: (a) Appropriate notice to each health care consumer was provided and no authorization or denial of authorization was received from each health care consumer within the 30-day time frame; (b) The objectives for which the data was requested could not be met without access to the requested data; and (c) The requested use or disclosure involves no more than minimal risk to the privacy of those health care consumers whose authorization will be waived based on the presence of attributes that include, at a minimum: (i) An adequate plan presented to the external and independent review committee to protect PHI from improper use, storage, and disclosure in accordance with current legal requirements and industry standards and practices as determined by the external and independent review committee; (ii) An adequate plan to destroy the PHI when the purposes for which it has been requested are completed, unless such retention is authorized under the waiver or otherwise required by law; and (iii) Adequate written assurances that the PHI will not be reused or disclosed to any person or entity, except as authorized under the waiver, as required or permitted by law, or for authorized oversight of the use. (4) An HIE may not disclose a patient’s sensitive health information for population health management purposes unless permitted by applicable federal and State laws and regulations. C. Research. (1) An HIE may disclose de-identified data to a qualified research organization for research purposes if a privacy board has evaluated and confirmed that the: (a) Requesting entity is a qualified research organization; and (b) Requested data to be disclosed: (i) Is for purposes related to research; (ii) Is limited to the minimum necessary to complete the research purpose; (iii) Will be used to serve a legitimate purpose consistent with the interest of the subject individuals; and (iv) Meets the de-identification standard and specifications in accordance with 45 CFR §164.514(a)—(c). (2) An HIE may disclose individually identifiable health information to a qualified research organization for research purposes if: (a) Approval is obtained from an IRB or privacy board in accordance with 45 CFR §164.512, including documentation of waiver approval as detailed in 45 CFR §164.512(i)(2); and (b) The IRB or privacy board has evaluated the request and confirmed that the requirements of §C(1)(a) and (b)(i)—(iii) of this regulation are met. (3) If an IRB or privacy board does not waive or alter the requirement of authorization from health care consumers whose individually identifiable health information is to be disclosed, an HIE may only disclose individually identifiable health information of health care consumers who have provided authorization, which must meet the requirements as set forth in 45 CFR §164.508. (4) If an IRB or privacy board declines jurisdiction, then the disclosure of individually identifiable health information may only be made if health care consumer authorization is obtained. (5) As part of an HIE’s data use agreement with an entity to which it disclosed individually identifiable health information for secondary use, there shall be oversight by an IRB or privacy board for the duration of the research use. (6) If an IRB or privacy board determines that the qualified research organization has failed to use or protect the data in accordance with the approved secondary use, the IRB or privacy board must report its findings to the HIE and the HIE must: (a) Report the findings to federal and State agencies with jurisdiction over the violation, as deemed appropriate; (b) Immediately terminate the data use agreement; and (c) Direct the qualified research organization to destroy the data previously released by the HIE and attest that the data has been destroyed. (7) The qualified research organization receiving data from an HIE for research purposes: (a) Must contractually agree not to attempt to link de-identified data received from the HIE with other data sources in an effort to re-identify the data, or otherwise attempt in any other way to re-identify the data; and (b) May disclose data to a third party acting on behalf of the qualified research organization only if the qualified research organization and third party enter into a data use agreement that requires the third party to be bound by the same provisions in the data use agreement between the HIE and qualified research organization. (8) An HIE may charge a reasonable fee to a qualified research organization to which it discloses data for research, which fee must reflect the effort and be no greater than the actual direct and indirect costs required to prepare and release the data specific to the purpose authorized. (9) An HIE may not disclose a patient’s sensitive health information for research purposes unless permitted by applicable federal or State laws and regulations. D. Enforcement and Reporting. (1) An HIE is not required to take legal or equitable action to enforce the requirements of the data use agreement or of any other contractual assurance provided for in Regulation .05C of this chapter. (2) An HIE shall make summary reports available to the public quarterly that provide specific information about requests for data for secondary use and the release of data for secondary purposes. (3) An HIE shall report at least annually to the Commission and more frequently, if requested by the Commission, regarding the release of information for population health management. The Commission may: (a) Require a care management organization to provide additional information for review by the Commission or the Commission’s designated third party regarding the care management organization’s use of data from an HIE for population health management; (b) Require the HIE to conduct an audit of the disclosure and use of the data utilizing a third-party auditor at the expense of either the recipient of the data or the HIE, as determined by Commission; (c) Require the receiving entity to destroy the data received and cease any further use of the data; or (d) Prohibit an HIE from releasing data for all or certain secondary data use purposes. (4) An HIE shall, upon the request by a health care consumer, provide an accounting of any disclosures made to a receiving entity for secondary data use purposes, in accordance with Regulation .03C(4) of this chapter. #### Regulation .11 Requirements for Accessing, Using, or Disclosing of Data Through an HIE in an Emergency. *COMAR 10.25.18.11* A. An HIE shall develop and implement emergency access policies and procedures that satisfy the following requirements: (1) The policies and procedures shall be included in the HIEs health care consumer education materials required by Regulation .03B(1) of this chapter; and (2) Clearly communicate the following: (a) The extent to which the HIE has the capability to disclose the patient's information in an emergency and how this compares to disclosure for routine access; and (b) The circumstances under which the HIE would disclose the patient's information in an emergency, including how opting in or out of participation would impact access to the patient's information during an emergency. B. If an HIEs emergency access policy allows the disclosure of information during an emergency, the HIE shall: (1) Only disclose information to the requesting health care provider if the following conditions are met: (a) The requesting health care provider: (i) Advises the HIE that it is the health care provider's professional opinion that an emergency exists; and (ii) Attests that all conditions of the participating organization's policy have been met; (b) The patient's condition preclude the participating organization from obtaining the consent of the health care consumer; (c) Information available through the HIE may be relevant to the treatment needed by the patient in the specific emergency; (d) The participating organization has an established policy that describes the requirements and attestation process for emergency access; and (e) Disclosure of information available through the HIE is not in violation of applicable federal and State laws and regulations related to sensitive health information. (2) Establish technical procedures for documenting an attestation by the requesting health care provider that the conditions in §B(1) of this regulation, were met prior to accessing information through the HIE; (3) Review the emergency access logs at least monthly, in coordination with the participating organization, to identify any unusual finding; (4) Take action in accordance with Regulation .06 of this chapter, in the event the emergency access log reveals an unusual finding; (5) Maintain an audit trail of user emergency access logs in accordance with Regulation .06A(8) of this chapter; and (6) Require a participating organization to: (a) Access only the minimum necessary information needed to care for the patient during the emergency encounter; (b) Discontinue querying of the patient's record upon the completion of the emergency encounter; (c) Allow emergency access only to authorized users with the appropriate access designation consistent with the policy of the participating organization; and (d) Notify the health care consumer, as soon as reasonably possible, and no later than ten business days from the initial access, when the HIE has granted access to the health care consumer's information during an emergency. #### Regulation .12 Requirements for Providing Health Care Consumers Electronic Access to Their Health Information. *COMAR 10.25.18.12* A. An HIE or its third party that offers health care consumers electronic access to view, download, transmit, submit, or control their health information shall: (1) Appropriately verify the identity of the health care consumer requesting electronic access or proposing an addition or change to the patient’s information available through the HIE prior to disclosing or accepting changes to the information; (2) Follow, at a minimum, the National Institute of Standards and Technology (NIST) Level 2 registration and identity proofing requirements as outlined in the most recent version of Special Publication 800-63: Electronic Authentication Guideline or its comparable industry best practices and may perform remote identity proofing; (3) Implement the health care consumer’s authorization for access within a maximum of 5 business days of receipt of all necessary information for identity proofing; (4) Adopt and implement authentication processes for health care consumer electronic access that is in accordance with Regulation .05D(3) and (4) of this chapter; (5) Establish individual unique user names and passwords in accordance with the most recent applicable standards issued by NIST, or other comparable standards generally adopted by the health care and HIE industry; (6) Implement processes for auditing health care consumer access that are in compliance with applicable requirements of Regulation .06 of this chapter; (7) Implement a process for suspending and reinstating a health care consumer’s access in compliance with applicable requirements in Regulation .07 of this chapter; (8) Establish processes and procedures to allow a patient to authorize an individual to have electronic access to their information; (9) Establish processes and procedures that allow an individual to electronically access health information for a patient or patients: (a) For whom the individual has legal authorization for such access (e.g., guardian, person with a medical power of attorney, etc.); or (b) For whom the patient has authorized such access; (10) Establish processes and procedures to confirm the authority of a person in interest, if not directly authorized by a patient, which must be satisfied as a condition to providing access to that person in interest; and (11) Comply with applicable federal and State laws and regulations related to sensitive health information when disclosing such information to a health care consumer. B. An HIE or its third party that offers health care consumers electronic access to view, download, transmit, submit, or control their information may: (1) Charge a reasonable cost-based published fee for healthcare consumer electronic access consistent with applicable federal and State laws; and (2) Deny a health care consumer’s electronic access in accordance with: (a) Applicable law or regulation, including 45 CFR §164.524, in coordination with applicable participating organizations; or (b) The HIE’s reasonable policies, procedures, or agreements with a participating organization and shall provide notice to the health care consumer of their right to request access to the patient’s health information from the covered entity. C. An HIE or its third party that offers health care consumer electronic access to view the patient’s health information available through the HIE shall, in accordance with federal and State law: (1) Provide the patient’s health information that is equivalent to what is made available to authorized users that are health care providers, which may include: (a) Demographic information, such as name, address, and date of birth; (b) Provider encounters or procedures performed (e.g., hospital, ambulatory, post-acute care, etc.); (c) Immunizations; (d) Visit summaries; (e) Care plan(s); (f) Clinical test results; and (g) Prescriptions; (2) At a minimum, and if made available through the HIE, make the following data attributes for the patient’s health information electronically available to the health care consumer: (a) Date of the encounter, procedure, test, prescription, or immunization; (b) Results or summary of the encounter, procedure, test, prescription, or immunization; and (c) Source of the health information, including provider name and organization name; (3) Inform health care consumers regarding: (a) Contacting their health care provider to discuss the health information they may be viewing if they have any concerns or questions; and (b) Translation services and resources that may be available, through the HIE or another entity, to help assist the health care consumer in understanding their health information; and (4) Allow the health care consumer to view the patient’s health information in an electronic format that meets the following criteria: (a) The information is presented in substantially the same form and format as presented to an authorized user that is a health care provider; (b) The form and format presented to a health care consumer is easy for the health care consumer to navigate; (c) The information can be easily printed; and (d) If supplemental information is made available along with the patient’s health information, such as educational resources, the supplemental information meets the criteria specified in Regulation .03B(2)(c)—(e) of this chapter. D. An HIE or its third party that offers health care consumers the ability to electronically control the patient’s health information being made available through the HIE shall: (1) Implement technology processes that meet industry standards and best practices and are in compliance with State and federal privacy and security laws; and (2) Provide an electronic process by which a health care consumer can control the patient’s health information that is in accordance with §C(4)(b)—(d) of this regulation. E. An HIE or its third party that offers health care consumers the ability to download the patient’s health information being made available through the HIE shall provide the patient’s health information that is: (1) In accordance with §C(3) and (4)(b)—(d) of this regulation; (2) Requested by the health care consumer; and (3) In a readily available industry standard format. F. An HIE or its third party that offers health care consumers the ability to submit information to the HIE: (1) Shall identify the source of the information, such as patient, payor, or health care provider, when presented to an authorized user of the HIE; and (2) May not use patient submitted health information to override or replace health information submitted from other sources. G. An HIE or its third party that offers health care consumers the ability to transmit the patients’ health information being made available through the HIE to a third party of the health care consumer’s designation shall comply with the requirements as detailed in: (1) §C(3) of this regulation; (2) §C(4)(b) and (d) of this regulation; and (3) §E(2) of this regulation. H. Health Care Consumer Education About Electronic Access. (1) An HIE shall provide needed information, as part of its health care consumer education plan (as detailed in .03B(1) of this chapter and meeting the characteristics as detailed in Regulation .03B(2) of this chapter), about the services or features offered by the HIE or its third party that allows the health care consumer to electronically view, download, submit, or control the patient’s information that is available through the HIE. (2) The health care consumer education plan shall outline the process which, if available, allows a health care consumer to electronically view, download, transmit, submit, or control the patient’s information that is available through the HIE, including: (a) The information the health care consumer must provide as part of patient identity proofing; (b) The patient’s rights to: (i) Authorize a person in interest or individual to also have access to the patient’s health information; and (ii) Request a review of a denial of access; (c) The extent to which the health care consumer has control of the patient’s health information being made available through the HIE; and (d) The need to safeguard information obtained from the HIE to the same extent they safeguard other sensitive personal information. #### Regulation .13 Noncontrolled Prescription Drugs Dispenser Reporting. *COMAR 10.25.18.13* A. For each noncontrolled prescription drug dispensed, the dispenser shall report drug information to the State-designated HIE in accordance with this regulation. B. MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual. (1) The Commission shall develop a MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual. (2) The Commission shall approve a MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual by June 1 of each year to be used for reporting by the last business day of September of the same calendar year. (3) The MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual shall minimally: (a) Specify the data and prescription drug information that must be submitted by dispensers to the State-designated HIE in accordance with this regulation, including specifying the American Society for Automation in Pharmacy (ASAP) standard; (b) Specify the timeframe and frequency of data submissions to the State-designated HIE; (c) Require a dispenser to report data elements consistent with the ASAP standard identified in MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual; (d) Include electronic reporting specifications, encryption algorithms, file layout, and the process for dispensers who are unable to submit data due to mechanical, electrical, or other technical failure; and (e) Align, to the extent possible, with the Maryland Prescription Drug Monitoring Program Data Submitter User Guide. (4) The Commission shall publish a draft Noncontrolled Prescription Drugs Dispenser Data Submission Manual on the Commission’s website and in the Maryland Register at least 30 days before the public meeting at which the Commission shall consider the manual for final approval and provide at least 20 days for the submission of public comment. (5) The Commission shall consider all comments received before final approval of the Noncontrolled Prescription Drugs Dispenser Data Submission Manual. (6) The Commission shall publish the final MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual on its website within 5 days of its approval. (7) The State-designated HIE shall post a link to MHCC’s Noncontrolled Prescription Drugs Dispenser Data Submission Manual prominently on its website. (8) The Commission may correct incomplete or erroneous information in the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual as necessary and shall provide notice of each correction: (a) On its website; and (b) By email to the designated dispenser contact person. C. Means of Data Submission and Data Format. A dispenser shall transmit noncontrolled prescription drug information to the State-designated HIE: (1) Consistent with the requirements detailed in the most recent version of the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual; (2) By use of an encrypted electronic transmission method or a secure electronic reporting form; and (3) In a format or utilizing data standards approved by the Commission. D. Reporting Deadline. (1) Unless granted a waiver under §F of this regulation, a dispenser shall report to the State-designated HIE: (a) The noncontrolled prescription drug information required by the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual no later than the end of the next day of operation after the prescription is dispensed; or (b) A zero report no later than the end of the next day of operation after a day without dispenses of noncontrolled prescription drugs. (2) A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser’s ability to report non-controlled prescription data electronically shall: (a) Notify the State-designated HIE by a communication method approved by the State-designated HIE within 24 hours of discovery of the technical failure; and (b) Submit a report for each noncontrolled prescription drug dispensed during the period of technical failure as soon as possible, but no later than 24 hours following reestablishment of the means of electronic reporting. E. Acceptance and Disclosure of Noncontrolled Prescription Drug Information by the State-designated HIE. (1) The State-designated HIE shall: (a) Electronically collect noncontrolled prescription drug information from dispensers; (b) Not impose any fees or other assessments on dispensers to support its operation; (c) Make information technology available for dispensers to report noncontrolled prescription drug information to the State-designated HIE; and (d) Retain noncontrolled prescription drug information collected pursuant to this section for at least 5 years from the date of receipt, except for the PHI of patients who opt-out of an HIE consistent with Regulation.03 of this chapter. (2) The State-designated HIE may reject data submitted by dispensers that does not comply with the requirements of the MHCC Noncontrolled Prescription Drugs Dispenser Data Submission Manual. (3) If the State-designated HIE rejects the data submitted by a dispenser, the dispenser shall correct and resubmit the data no later than 7 business days after receiving notification from the State-designated HIE of receipt of incomplete or inaccurate data. (4) Beginning January 1, 2026, the State-designated HIE shall make patient-specific prescription information submitted by dispensers under this section available for purposes allowed under applicable law. (5) Upon written request for public health purposes and as allowed by applicable law, the State-designated HIE shall provide data collected under this regulation within 5 days to the Maryland Department of Health, local health departments, the Commission, or the Health Services Cost Review Commission. F. Dispenser Waiver Request Process. (1) Prior to September 1, 2025, dispensers of noncontrolled prescription drug information are exempt from reporting dispensed information to the State-designated HIE. (2) A dispenser that dispenses noncontrolled prescription drugs may seek a waiver from the Commission of the requirements in this regulation based on: (a) Economic hardship; (b) Technology limitations that are not reasonably within the dispenser’s control; (c) Dispensing less than 100 noncontrolled prescription drugs annually; or (d) Other circumstances determined by the Commission to be extenuating. (3) A request for a waiver shall be in writing and shall include: (a) A detailed explanation of the need for the waiver; (b) An attestation as to the accuracy of the information in the waiver request; and (c) An attestation that the dispenser shall immediately inform the Commission if the circumstances necessitating a waiver no longer exist. (4) Within 45 days after receipt of complete information from a dispenser requesting a waiver, the Commission shall: (a) Grant a time-limited waiver request; or (b) Deny the waiver request, with an explanation that enumerates the reasons for the denial. (5) A dispenser shall inform the Commission and immediately begin reporting in compliance with this regulation if the dispenser no longer meets the conditions of a waiver request. #### Regulation .14 Operation of the State-designated HIE as a Health Data Utility. *COMAR 10.25.18.14* A. The State-designated HIE shall operate as a health data utility for the State. B. The State-designated HIE shall implement a consent management application in accordance with Regulation .03D of this chapter. C. Disclosures by the State-designated HIE. (1) Except as otherwise prohibited under this chapter or State or federal law, the State-designated HIE shall transmit clinical information or electronic health care transactions to the Maryland Department of Health, the Commission, or the Health Services Cost Review Commission for public health purposes upon written request. (2) The State-designated HIE may not redisclose financial information in electronic health care transactions it receives in accordance with COMAR 10.25.07.09 to any person other than the Commission. (3) Maryland Medical Care Data Base. (a) The State-designated HIE shall be designated as a reporting entity to the Maryland Medical Care Data Base. (b) The State-designated HIE shall report the electronic health care transactions information it receives pursuant to COMAR 10.25.07.09 to the Medicare Care Data Base in accordance with the reporting requirements found in COMAR 10.25.06. (4) The State-designated HIE shall: (a) Develop a process in which requests for data are submitted and data are shared, and post this information on its website; and (b) Provide a written explanation for a denial of a request which shall include an appeal process. D. The State-designated HIE shall consult with the Maryland Department of Health, the Commission, and Health Services Cost Review Commission before identifying any specific purposes, type of data exchanged, and rules for interaction between users and the State-designated HIE pertaining to: (1) A State health improvement program; (2) Mitigation of a public health emergency; (3) Improvement of patient safety; and (4) Any other public health priorities identified by the Secretary. E. Consumer Advisory Council. (1) The State-designated HIE shall establish a Consumer Advisory Council in accordance with Health-General Article, §19-145, Annotated Code of Maryland. (2) The State-designated HIE shall: (a) Appoint two consumer representatives identified by the Commission who have significant experience in public health and patient privacy as council members; (b) Post advance notice of council meetings on its website, including an expected agenda; and (c) Require the Consumer Advisory Council to comply with the requirements of the Maryland Open Meetings Act as if it were a public body. ### Chapter 19 — State Recognition of an Electronic Advance Directives Service **Authority:** Health-General Article, §§4-302.2, 5-602, 5-622, 19-103(c)(2)(i) and (ii), and 19-144, Annotated Code of Maryland **Administrative History:** Effective date: March 12, 2018 (45:5 Md. R. 285) **Administrative History:** Regulation .02B amended effective January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .03 amended effective January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .04B, d amended effective January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .07 amended effective January 9, 2023 (49:27 Md. R. 1110) **Administrative History:** Regulation .08 amended effective January 9, 2023 (49:27 Md. R. 1110) #### Regulation .01 Scope. *COMAR 10.25.19.01* This chapter applies to the State Recognition of an electronic advance directives service. Only an electronic advance directives service that is awarded State Recognition status by the Maryland Health Care Commission pursuant to this chapter may represent itself as a State-Recognized electronic advance directives service that is authorized to connect to the State-Designated Health Information Exchange. #### Regulation .02 Definitions. *COMAR 10.25.19.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advance Care Planning” means a process through which an individual considers and documents in a formal manner the individual’s preferences for the receipt of health care, including through the use of an advance directive. (2) “Advance directive” has the meaning stated in Health-General Article, Title 5 Subtitle 6, Annotated Code of Maryland. (3) “Commission” means the Maryland Health Care Commission. (4) “Declarant” means a competent individual who makes an advance directive while capable of making and communicating an informed decision. (5) “Electronic advance directives service” or “service” means a corporation, firm, association, or other entity that offers electronic advance directives services by way of a web-based application using cloud-based technology. (6) “Executive Director” means the Executive Director of the Commission. (7) “Health care agent” means an individual appointed by a declarant under an advance directive to make health care decisions on behalf of a declarant. (8) “State-Designated HIE” means an entity designated by the Maryland Health Care Commission and the Health Services Cost Review Commission pursuant to the statutory authority set forth under Health-General Article, §19-143, Annotated Code of Maryland. (9) “State Recognition” or “State-Recognized” means the status awarded by the Commission to an approved electronic advance directives service that has met State Recognition criteria. (10) “State Recognition criteria” or “criteria” means technology, security, privacy, and other standards established by the Commission in accordance with Regulation .03 of this chapter. (11) “Vendor” means an electronic advance directive service.. #### Regulation .03 Criteria for State Recognition of an Electronic Advance Directives Service. *COMAR 10.25.19.03* A. The Commission will assess the application of an electronic advance directives service for State Recognition in accordance with criteria approved by the Commission in accordance with the process set forth in this Regulation. B. Commission staff shall publish in the Maryland Register and on the Commission’s website a notice and draft criteria by which the Commission may consider an application of an electronic advance directives service for State Recognition. (1) The notice shall specify the date by which public comments are due. (2) Commission staff shall analyze public comments received and recommend criteria for use by the Commission in determining whether the Commission will award State Recognition to an electronic advance directives service. C. The Commission will consider the public comments and Commission staff’s recommendation in establishing the applicable criteria. D. The criteria approved by the Commission shall be published in the Maryland Register and in a dated posting on the Commission’s website. #### Regulation .04 Procedure for Initial State Recognition. *COMAR 10.25.19.04* A. Application. (1) An electronic advance directives service seeking State Recognition shall submit an application in the form and manner specified by the Commission. (2) The application, and all information supplementing the application, shall be signed by at least one person authorized by the applicant, who shall sign a statement as follows: “I solemnly affirm under penalties of perjury that the contents of this application (or the supplementary information) are true to the best of my knowledge, information, and belief.” B. An electronic advance directives service seeking State Recognition shall: (1) Demonstrate that it meets all State Recognition criteria in effect at the date of the Commission's receipt of the initial application; (2) Affirm under penalties of perjury that, within the last 10 years, no current or former owner or senior manager of the service or a current or former owner or senior manager of any related or affiliated service has: (a) Been convicted of a felony or pleaded guilty, nolo contendere, entered a best interest plea of guilty, or received a diversionary disposition regarding a felony; (b) Received a determination of exclusion from participation in Medicare or State health care programs under 42 U.S.C. §1320a-7 in any case with respect to a criminal or civil charge of Medicare or Medicaid fraud or abuse; or (c) Been found in violation of State or federal laws or regulations that govern the operation of, or relate in any way to, an electronic advance directives service; (3) Affirm under penalties of perjury that the service or any related or affiliated service: (a) Has no pending complaints, judgments, liens, or any final judgment or liens; or (b) Has not been the subject of an investigation by or order of any local, State, or federal governmental agency; (4) Provide all required documentation; (5) Timely provide additional information requested by Commission staff as needed to complete analysis of the application and make a recommendation to the Commission; (6) Send written notice to the Commission of any change in information submitted in the initial application within ten business days after the change is effective; and (7) Agree to comply with the requirements of this chapter. C. Review of Applications. (1) Commission staff shall: (a) Review an application to determine its compliance with State Recognition criteria; and (b) Prepare a recommendation to the Commission on the application, detailing the reasons for the recommendation. (2) If Commission staff recommends denial of an application for State Recognition: (a) An applicant has ten days after electronic delivery of the Commission staff's recommended denial in which to make a written filing taking exceptions to the staff's recommendation; and (b) Each applicant that timely submits a written filing may present oral argument on its written exceptions to the Commission, not to exceed 10 minutes per applicant unless time is extended by the Chair of the Commission. (3) The Commission may award State Recognition to each electronic advance directives service that meets all State Recognition criteria unless the Commission: (a) Determines that it is in the public interest to award State Recognition to fewer than all the electronic advance directives services that meet the qualifications for State Recognition; and (b) Details the bases for its decision. D. Duration of State Recognition. (1) State Recognition is valid for three years from its issuance, unless suspended or revoked by the Commission. (2) An electronic advance directives service to which the Commission grants State Recognition shall acknowledge the status in writing and agree to comply with the terms and conditions of the award of State Recognition status. #### Regulation .05 Procedure for Renewal of State Recognition. *COMAR 10.25.19.05* A. An electronic advance directives service seeking renewal of its State Recognition status shall: (1) At least 45 days prior to the expiration of State Recognition status, file a complete application for renewal in a form and manner specified by the Commission; and (2) Demonstrate compliance with the State Recognition criteria in effect at the date of the Commission’s receipt of the application for renewal. B. Commission staff shall review a renewal application and make a recommendation to the Commission regarding: (1) The applicant’s compliance with the State Recognition criteria; (2) The applicant’s compliance with terms and conditions of the prior recognition; and (3) Its assessment of the quality of the service provided by the electronic advance directives service. C. The Commission shall approve an application for renewal of State Recognition status by an electronic advance directives service that: (1) Continues to meet all State Recognition criteria; (2) Has complied with the terms and condition of its previous award of State Recognition status; and (3) Has provided high quality service to persons who utilize its electronic advance directives service. D. If Commission staff recommends denial of a renewal application, the procedure in Regulation .04C(2) of this chapter applies. #### Regulation .06 Nontransferability of State Recognition. *COMAR 10.25.19.06* State Recognition issued pursuant to this chapter may not be sold, assigned, leased, or transferred in any way, except as provided in Regulation .07 of this chapter. #### Regulation .07 Closure, Sale, Merger, Lease, Assignment, or Transfer of All or Part of a State-Recognized Electronic Advance Directives Service. *COMAR 10.25.19.07* A. At least 90 days before a State-Recognized electronic advance directives service closes on a sale, merger, lease, assignment, or transfer of all or part of a State-Recognized electronic advance directives service, the State-Recognized electronic advance directives service shall: (1) Submit in writing to the Commission information requested by Commission staff about the desired change and a plan that assures the proposed transaction: (a) Results in the secure transfer to another State-Recognized electronic advance directives service; (b) Provides notice of the proposed transaction to the Commission, to the Maryland Department of Health, to the State-Designated Health Information Exchange, and to the Consumer Protection Division of the Office of the Maryland Attorney General; and (c) Provides notice of the proposed transaction electronically and on the Vendor’s website to each declarant who prepared an electronic advance directive through the service and health care agent named in an electronic advance directive, which at a minimum, includes: (i) Information about the transfer of the declarant’s advanced directive to another State-Recognized entity; (ii) The name, contact information and web address of the State-Recognized receiving entity; (iii) The date the transfer will occur; and (iv) Specific instructions about how the transfer of an advance directive impacts the declarant and the health care agent. (2) Not proceed with the proposed transaction until it receives written determination from the Executive Director that State Recognition status may be transferred as a result of the proposed sale, merger, lease, assignment, or transfer of all or part of a State-Recognized electronic advance directives service. (3) The provisions of §A(1) of this regulation do not apply to a State-Recognized electronic advance directives service that seeks to sell, merge, lease, assign, or transfer all or part of a State-Recognized electronic advance directives service to: (a) A person who was identified as a majority owner of the electronic advance directives service at the time of the most recent State Recognition by the Commission; or (b) To an entity identified as the majority owner of the electronic advance directives service at the time of the most recent State Recognition by the Commission and whose membership or ownership, and percentage of ownership remain substantially the same as identified at the time of the most recent State Recognition by the Commission. B. As soon as a State-Recognized electronic advance directives service has information that sets forth a reasonable basis to believe that its ability to continue to operate as a State-Recognized electronic advance directives service will be materially affected, and no fewer than 90 days prior to an anticipated closure, it shall submit complete written information to the Commission, along with a plan that includes provisions assuring the following: (1) The secure transfer of electronic advance directives to another State-Recognized electronic advance directives service to the extent that such transfer is consistent with State and federal law; (2) Submission of any reporting required under an existing State or federal grant; (3) Plans for the continuation of electronic advance directives services during a period of transition and for a mutually agreed timeframe prior to the transfer of electronic advance directives to another State-Recognized electronic advance directives service or until the Commission awards State Recognition to a new electronic advance directives service to whom the existing service shall transfer existing advance directives; (4) Plans for such transition services to a successor State-Recognized electronic advance directives service as are reasonably feasible given the circumstances of the closure; and (5) A minimum of 45 days advance notice of the full or partial closure to each declarant who prepared an electronic advance directive through the service and health care agent named in an electronic advance directive in accordance with §A(1)(c) of this regulation, to the Commission, to the Maryland Department of Health, to the State-Designated Health Information Exchange, and the Consumer Protection Division of the Office of the Maryland Attorney General. #### Regulation .08 Commission Oversight of State-Recognized Electronic Advance Directives Services. *COMAR 10.25.19.08* A. Commission staff may, on its own initiative or in response to information provided to the Commission, investigate any State-Recognized electronic advance directives service. B. Failure of a State-Recognized electronic advance directives service to provide full information requested by Commission staff in a timely and complete manner is grounds for suspension or revocation of State Recognition status. C. Following Commission staff’s investigation, the Executive Director may issue a notice of proposed action, which may include the following: (1) A time-limited opportunity to correct deficiencies identified by the investigation; (2) Suspension of the State Recognition of an electronic advance directives service for a definite period of time after which, depending upon the circumstances of the case and completion of appropriate corrective actions, the Vendor may seek reinstatement of its State Recognition; or (3) Revocation of State Recognition. D. An electronic advance directives service that receives a notice of proposed action from the Executive Director may request an opportunity to show cause why the proposed action should not be implemented. A written request to show cause shall be filed with the Commission within 20 days of the issuance of the notice of proposed action and shall: (1) State with particularity the grounds and factual basis for the electronic advance directives service's disagreement with the proposed action; (2) Include each fact upon which the electronic advance directives service relies to show cause why the proposed action should not be taken; and (3) Be supported by relevant documentation and affidavits. E. The Commission shall determine whether to impose the proposed action or a different action under the exceptions procedure provided in Regulation .04C(2) of this chapter. F. In the event that State Recognition status is not renewed, or the Commission suspends or revokes State Recognition status, the electronic advance directives service must notify each declarant who prepared an electronic advance directive through the service and health care agent named in an electronic advance directive about the impact of the action on accessibility of the advance directive. ## Subtitle 26 — Board of Acupuncture ### Chapter 01 — Fee Schedule **Authority:** Corporations and Associations Article, §§5-101 — 5-131;Health Occupations Article, §§1A-205, 1A-206, and 1A-302; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.04 adopted as an emergency provision under COMAR 10.26.02 effective December 23, 1994 (22:2 Md. R. 72); emergency status expired June 23, 1995 **Administrative History:** Regulations .01—.03 adopted effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .01 amended effective April 20, 2009 (36:8 Md. R. 596) **Administrative History:** Regulation .02 amended effective October 1, 2001 (28:19 Md. R. 1685); April 20, 2009 (36:8 Md. R. 596) **Administrative History:** Regulation .03 amended effective June 17, 1996 (23:12 Md. R. 871) **Administrative History:** Regulation .03 amended as an emergency provision effective December 5, 1997 (24:26 Md. R. 1752); amended permanently effective May 4, 1998 (25:9 Md. R. 680) **Administrative History:** Regulation .03 amended effective October 1, 2001 (28:19 Md. R. 1685) **Administrative History:** Regulation .03 amended as an emergency provision effective December 7, 2001 (28:26 Md. R. 2270); emergency status expired June 4, 2002 **Administrative History:** Regulation .03 amended as an emergency provision effective June 1, 2002 (29:12 Md. R. 924); amended permanently effective August 5, 2002 (29:15 Md. R. 1142) **Administrative History:** Regulation .03 amended effective April 20, 2009 (36:8 Md. R. 596); October 17, 2011 (38:21 Md. R. 1279) **Administrative History:** Regulation .03A, M amended effective August 5, 2013 (40:15 Md. R. 1229) **Administrative History:** Regulation .03D amended effective December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .03G amended effective December 21, 2015 (42:25 Md. R. 1543) **Administrative History:** Regulation .03M, N adopted effective April 11, 2005 (32:7 Md. R. 681) #### Regulation .01 Scope. *COMAR 10.26.01.01* The fee schedule applies to all acupuncturists who apply for licensure or license renewal and auricular detoxification specialists. #### Regulation .02 Definitions. *COMAR 10.26.01.02* A. In this chapter, the following term has the meaning indicated. B. Term Defined. “Board” means the State Board of Acupuncture. #### Regulation .03 Fees. *COMAR 10.26.01.03* The following fees are established by the Board: A. Initial application — $525; B. Renewal application — December 1997 and beyond — $525; C. Application for inactive status — $100; D. Late application (any application) — $100; E. Reinstatement — $200; F. Fine for failure to notify Board of change in name or address — $50; G. Examination equivalency review plus all necessary travel, accommodations, and translation or other expenses — $250; H. Application for professional corporate name — $20; I. Application for certification to practice acupuncture on animals — $100; J. Auricular detoxification specialist registration — $50; K. Auricular detoxification specialist registration renewal — $25; L. Auricular detoxification specialist registration reinstatement — $100; M. License verification — $50; and N. Roster — $25. ### Chapter 02 — General Regulations **Authority:** Agriculture Article, §§2-301(g) and 2-304; Health Occupations Article, §§1-211, 1A-101, 1A-205, 1A-301, 1A-302, 1A-306, 1A-307, and 1A-316; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.05 adopted as an emergency provision effective February 22, 1996 (23:6 Md. R. 472); adopted permanently effective August 12, 1996 (23:16 Md. R. 1175) **Administrative History:** Regulation .02 amended effective October 1, 2001 (28:19 Md. R. 1685) **Administrative History:** Regulation .02B amended effective December 11, 2003 (30:24 Md. R. 1741); January 1, 2007 (33:26 Md. R. 1997) **Administrative History:** Regulation .03D amended effective March 9, 1998 (25:5 Md. R. 369); December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .03D, E amended effective October 1, 2001 (28:19 Md. R. 1685) **Administrative History:** Regulation .03E amended effective January 1, 2007 (33:26 Md. R. 1997) **Administrative History:** Regulation .03G adopted effective February 16, 2004 (31:3 Md. R. 207) **Administrative History:** Regulation .05 amended effective October 1, 2001 (28:19 Md. R. 1685); December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .05E amended effective April 11, 2005 (32:7 Md. R. 681) **Administrative History:** Regulation .05F amended effective January 1, 2007 (33:26 Md. R. 1997) **Administrative History:** Regulation .06 adopted as an emergency provision effective December 5, 1997 (24:26 Md. R. 1752); adopted permanently effective May 4, 1998 (25:9 Md. R. 680) **Administrative History:** Regulation .06A amended effective January 1, 2007 (33:26 Md. R. 1997) **Administrative History:** Regulation .06B amended effective February 22, 1999 (26:4 Md. R. 273) **Administrative History:** Regulation .07 adopted effective June 15, 1998 (25:12 Md. R. 947) **Administrative History:** Regulation .07A amended effective January 1, 2007 (33:26 Md. R. 1997) **Administrative History:** Regulation .08 adopted effective June 15, 1998 (25:12 Md. R. 947) **Administrative History:** Regulation .08A, D amended effective January 1, 2007 (33:26 Md. R. 1997) **Administrative History:** Regulation .09 adopted as an emergency provision effective December 7, 2001 (28:26 Md. R. 2270); emergency status expired June 4, 2002 **Administrative History:** Regulation .09 adopted as an emergency provision effective June 1, 2002 (29:12 Md. R. 924); adopted permanently effective August 5, 2002 (29:15 Md. R. 1142) **Administrative History:** Regulation .09 amended as an emergency provision effective January 19, 2005 (32:3 Md. R. 287); amended permanently effective April 11, 2005 (32:7 Md. R. 681) **Administrative History:** Regulation .09 amended effective November 7, 2005 (32:22 Md. R. 1756) **Administrative History:** Chapter revised effective April 20, 2009 (36:8 Md. R. 596) **Administrative History:** Regulation .02B amended effective December 28, 2009 (36:26 Md. R. 1995); October 16, 2023 (50:20 Md. R. 887); April 13, 2026 (53:7 Md. R 328) **Administrative History:** Regulation .03 amended effective April 13, 2026 (53:7 Md. R 328) **Administrative History:** Regulation .03D amended effective January 29, 2018 (45:2 Md. R. 69); October 16, 2023 (50:20 Md. R. 887) **Administrative History:** Regulation .03E amended effective October 16, 2023 (50:20 Md. R. 887) **Administrative History:** Regulation .03F repealed effective October 16, 2023 (50:20 Md. R. 887) **Administrative History:** Regulation .03G repealed effective January 29, 2018 (45:2 Md. R. 69) **Administrative History:** Regulation .04 amended effective April 13, 2026 (53:7 Md. R 328) **Administrative History:** Regulation .04E repealed effective October 16, 2023 (50:20 Md. R. 887) **Administrative History:** Regulation .05 amended effective February 20, 2012 (39:3 Md. R. 259); August 5, 2013 (40:15 Md. R. 1229); April 13, 2026 (53:7 Md. R 328) **Administrative History:** Regulation .05D amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .05F amended effective December 28, 2009 (36:26 Md. R. 1995) **Administrative History:** Regulation .05F repealed effective October 16, 2023 (50:20 Md. R. 887) **Administrative History:** Regulation .06 amended effective April 13, 2026 (53:7 Md. R 328) **Administrative History:** Regulation .07 amended effective October 18, 2010 (37:21 Md. R. 1436); October 17, 2011 (38:21 Md. R. 1279); January 7, 2013 (39:26 Md. R. 1665); April 13, 2026 (53:7 Md. R 328) **Administrative History:** Regulation .08 adopted effective April 13, 2026 (53:7 Md. R 328) **Administrative History:** Regulation .09 effective April 13, 2026 (53:7 Md. R 328) #### Regulation .01 Scope. *COMAR 10.26.02.01* A. This chapter governs the practice of acupuncture. B. This chapter does not apply to: (1) An individual employed by the federal government as an acupuncturist while practicing within the scope of that employment; (2) A student, trainee, or visiting teacher designated as such while participating in a course of study or training under the supervision of a licensed acupuncturist in a program approved by the Board or the Maryland Higher Education Commission; or (3) An individual practicing a health occupation who is authorized to practice under a provision of the Annotated Code of Maryland, including: (a) A physician authorized under Health Occupations Article, Title 14, Annotated Code of Maryland, to perform acupuncture as it is defined in that title, (b) A dentist authorized under Health Occupations Article, Title 4, Annotated Code of Maryland, to perform acupuncture in connection with the practice of dentistry, or (c) A veterinarian licensed under the Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, who performs acupuncture on animals in connection with the practice of veterinary medicine. #### Regulation .02 Definitions. *COMAR 10.26.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ABAA” means the American Board of Animal Acupuncture. (2) “ACAHM” means the Accreditation Commission for Acupuncture and Herbal Medicine. (3) “Acupoint injection therapy” means a form of acupuncture that stimulates acupuncture points by subcutaneous, intramuscular, and intradermal injection with approved sterile substances, specifically manufactured for non-intravenous injection. (4) “Acupuncture” means a form of health care based on East Asian medical theories of energetic physiology that describe the interrelationship of the body organs and functions of a human or animal. (5) “Applicant” means an individual who has applied to the Board for a license to practice acupuncture in this State. (6) “Auricular detoxification” means an acupuncture technique that involves needling the external auricle of the human ear to assist individuals undergoing detoxification from addictive substances and restore health. (7) “Board” means the State Board of Acupuncture. (8) “CCAHM” means the Council of Colleges of Acupuncture and Herbal Medicine. (9) “License” means a license issued by the Board to practice acupuncture in this State. (10) “NADA” means the National Acupuncture Detoxification Association. (11) “NCCAOM” means the National Commission for the Certification of Acupuncture and Oriental Medicine. (12) “Practice acupuncture” means the use of East Asian medical therapies for the purpose of normalizing energetic physiological functions including pain control, and for the promotion, maintenance, and restoration of health including, but not limited to: (a) Stimulation of a human or animal body by the insertion of needles; (b) The application of moxibustion; and (c) Manual, mechanical, thermal, or electrical therapies only when performed in accordance with the principles of] East Asian medical theories. (13) “Pro bono work” means work provided within the scope of practice of the licensee: (a) Without financial reimbursement; or (b) Without direct financial gain. (14) “TOEFL” means the Test of English as a Foreign Language. #### Regulation .03 Application for License. *COMAR 10.26.02.03* A. To qualify for a license, an applicant shall: (1) Submit a completed application in the format provided by the Board; (2) Provide at the applicant's expense, in English, all documentation required by §§B and C of this regulation or copies of original documents with English translations; (3) Pay the necessary fees established in COMAR 10.26.01.03; (4) Submit a current copy of a: (a) Government-issued photographic identification; or (b) Passport-size photograph; and (5) Meet with the Board to review the application if requested by the Board. B. To prove that the applicant is 18 years old or older, the applicant shall provide a certified copy of an official government or institutional record, if requested by the Board. C. The applicant shall provide documentary evidence of having met one of the following standards for education, training, or demonstrated experience: (1) Graduation with a master’s degree from an accredited educational institution with a practice relevant course of training that is equivalent to or exceeds at least 1,800 hours in acupuncture, including 300 clinical hours, that is: (a) Approved by the Maryland Higher Education Commission; (b) Accredited by the ACAHM; or (c) Found by the Board to be equivalent to a course approved or accredited by the authority listed under §C(1)(a) or (b) of this regulation; or (2) Achievement of a: (a) Diplomate in Acupuncture from the NCCAOM; or (b) Passing score on an examination that is determined by the Board to be equivalent to the examination given by the NCCAOM. D. An applicant shall demonstrate proof of proficiency in the written and oral communication of the English language by providing documentary evidence that the applicant has: (1) Completed at least 30 classroom credits from: (a) An English-speaking undergraduate school; (b) An English-speaking professional school; (c) A community college; or (d) An undergraduate or graduate program at a college or university; (2) Achieved a passing score on the TOEFL within the 2 years preceding license application; or (3) Provided proof of passing scores on the NCCAOM written and practical examination components in English. #### Regulation .04 Approval of Applicant for Licensure. *COMAR 10.26.02.04* A. The Board shall determine whether an application is complete as received, with all required documentation enclosed. B. Within 90 days of its receipt of a completed application and required information or documentation, the Board shall approve or deny the application. C. The Board may close an incomplete application when the information needed to complete the application is not received within 120 days of the submission date. D. Upon approval of an application, the Board shall issue a document authorizing the applicant to practice acupuncture in this State in accordance with Health Occupations Article, §1A-304, Annotated Code of Maryland, and the regulations in this chapter. E. Except with approval of the Board, an applicant may not withdraw an application while under investigation or after having received a notice of denial of licensure. #### Regulation .05 Term, Renewal, Reinstatement, and Inactive Status. *COMAR 10.26.02.05* A. Unless renewed, the term of a license is valid through the expiration date. B. Renewal. (1) At least 1 month before a license expires, the Board shall send to the licensee a renewal notice that states the: (a) Date on which the current license expires; (b) Date by which the renewal application is to be received by the Board for the renewal to be issued and mailed before the license expires; and (c) Amount of the renewal fee. (2) Before a license expires, the licensee may renew if the licensee: (a) Submits to the Board a completed renewal application in the format required by the Board along with documentation that the licensee meets the requirements for a license; (b) Pays the renewal fee specified in COMAR 10.26.01.03; and (c) If requested, submits to the Board documentation that the licensee has complied with the continuing education requirements established under COMAR 10.26.06. (3) A licensee shall keep the Board apprised of the licensee's current address and telephone number or shall pay a fee as specified in COMAR 10.26.01.03. C. A licensee has a grace period of 30 days after the licensee's license expires to renew retroactively if the licensee: (1) Otherwise is entitled to have the license renewed; and (2) Pays to the Board the renewal fee and late fee set by the Board. D. If the applicant’s license expires, an applicant may not practice acupuncture in the State until the renewal application is approved by the Board. E. Reinstatement. Thirty-one days after the expiration date of a license, a licensee whose license has expired without seeking inactive status may have the license reinstated upon meeting all of the following: (1) Submission of a completed reinstatement application in the format required by the Board; (2) Payment of the reinstatement fee, and renewal fee, specified in COMAR 10.26.01.03; and (3) One of the following: (a) Thirty hours of continuing education within the 2 years that are most recent to the requested reinstatement date; or (b) Passage of the acupuncture exam given by the NCCAOM within 4 years from the date of reinstatement. F. Inactive Status. (1) The Board shall place a licensee on inactive status for a maximum period of 6 years if the licensee submits to the Board within 30 days after the expiration of a license: (a) An application for inactive status in the format required by the Board; and (b) The inactive status application fee specified in COMAR 10.26.01.03. (2) To reactivate a license from inactive status, the applicant shall: (a) Satisfy the renewal requirements in §B(2)(a) and (b) of this regulation that exist at the time the individual changes from inactive to active status; and (b) Complete 30 hours of continuing education as specified under COMAR 10.26.06. (3) The licensee shall renew inactive status every 2 years, but not to exceed 6 years, in the format required by the Board and pay the fee as set forth in COMAR 10.26.01.03. G. Continuing Education. (1) A licensee applying for renewal shall complete 30 hours of relevant continuing education during the 2-year period preceding the expiration of the license which include the following: (a) At least 20 hours in formally organized programs which are relevant to the practice of acupuncture and Oriental medicine and are approved by the Board or sponsored by, but not limited to, the following organizations and their member organizations: (i) American Academy of Medical Acupuncture; (ii) American Association of Acupuncture and Oriental Medicine (AAAOM); (iii) Council of Colleges of Acupuncture and Oriental Medicine (CCAOM); (iv) Colleges and universities accredited by the Accreditation Commission for Acupuncture and Oriental Medicine (ACAOM); (v) National Commission for the Certification of Acupuncture and Oriental Medicine (NCCAOM); (vi) Society for Acupuncture Research; or (vii) The National Acupuncture Detoxification Association; (b) Not more than 10 hours of formally organized training programs in Western science and medical practices, medical ethics, medical research, or cardiopulmonary resuscitation which are relevant to the practice of acupuncture and are sponsored by, but not limited to, organizations listed in §F(1)(a) of this regulation and the following organizations: (i) World Health Organization (WHO); (ii) National Institutes of Health (NIH); (iii) American Medical Association (AMA); (iv) American Nurses Association (ANA); (v) American Psychiatric Association (APA); (vi) Red Cross; (vii) Local colleges; or (viii) Local hospitals; (c) Not more than 10 hours of training in approved programs which will assist a licensee to carry out the licensee's professional responsibilities, including, but not limited to: (i) Management courses for a school administrator; (ii) Foreign language training for translators of relevant texts; (iii) Educational methodology for teachers of acupuncture; (d) Not more than 10 hours teaching acupuncture and related Oriental medical therapies in an accredited school or in a program approved for acupuncture continuing education; (e) Not more than 7 hours of pro bono work as outlined in §F(3) of this regulation; or (f) Not more than 7 hours in published writing or articles in acupuncture and Oriental medicine that are: (i) Peer-reviewed research or peer-reviewed clinically relevant articles in acupuncture and Oriental medicine; and (ii) Limited to 4 hours per article. (2) Pro Bono Work. (a) Pro bono work shall earn 1 credit hour for each 3 hours of pro bono activity up to a maximum of 7 credit hours per renewal cycle. (b) Pro bono work shall be for the provision of acupuncture services provided through an organization offering humanitarian services such as, but not limited to: (i) Domestic or international victims in an emergency situation or disaster area; (ii) Low income or underserved areas or populations; (iii) Special needs populations; or (iv) United States military personnel. (c) Upon completion of the pro bono work, the licensee shall obtain from the facility written documentation of completion of pro bono hours including: (i) The name of the facility; (ii) The address where the pro bono work was provided; (iii) The type of work that was done; (iv) The number of hours of actual work provided for which the licensee desires credit hours; and (v) A statement guaranteeing that the work provided no financial benefit to licensee. (3) Licensees shall maintain the documentation of their continuing education credits for 4 years from the date of their acupuncture renewal. (4) If requested by the Board, a licensee shall provide proof of continuing education attendance by providing documentation of: (a) Name of the program; (b) Date of the program; (c) Number of continuing education hours earned; and (d) Name of the sponsoring organization. H. Change of Mailing Address, Legal Name, or Email Address. (1) A licensee shall give the Board written notice within 30 days of a change of: (a) Mailing address; (b) Legal name; or (c) Email address if the licensee has previously submitted an email address to the Board. (2) Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a fee as set forth under COMAR 10.26.01.03. #### Regulation .06 Acupuncture on Animals. *COMAR 10.26.02.06* A. To obtain certification from the Board as qualified to practice acupuncture on animals, an applicant shall: (1) Possess a current active license to practice acupuncture in Maryland; (2) Successfully complete a Board-approved specialty training program in animal acupuncture from a school accredited by ABAA, ACAHM, or approved by the Maryland Higher Education Commission that consists of a minimum of 135 hours of theory and clinical training and includes at a minimum in each of the following: (a) 90 hours in diagnosis of energy dynamics and treatment of animals, (b) 15 hours in comparative functional anatomy and physiology of animals, (c) 15 hours in animal handling, restraints, and emergencies, and (d) 20 hours in introduction to animal diseases and zoonotics that require the immediate attention of a veterinary practitioner; (3) Complete and submit the application provided by the Board; and (4) Pay the fee as specified in COMAR 10.26.01.03. B. To practice acupuncture on animals, the licensed acupuncturist: (1) Shall possess certification for animal acupuncture from the Board; (2) Shall cooperate and consult with a veterinarian licensed in the State by: (a) Beginning acupuncture treatment on an animal only if the animal has been seen by a veterinary practitioner within the previous 14 days, (b) Adhering to the terms and conditions of treatment decided by the veterinary practitioner, including the degree of communication and collaboration between the veterinary practitioner and the individual practicing acupuncture, and (c) Reporting to the veterinary practitioner at the end of the animal's acupuncture treatment or at monthly intervals at the discretion of the veterinary practitioner; and (3) May not practice acupuncture on an animal for which the licensed acupuncturist has not been appropriately trained in accordance with this regulation. C. Certification Renewal, Reinstatement, and Reactivation. (1) The licensee may, as a part of the 30 continuing education unit renewal requirement, complete at least 5 continuing education units directly related to the certification of veterinary or animal related acupuncture. (2) The licensee may, as a part of the 30 continuing education unit reinstatement requirement, complete at least 5 continuing education units directly related to the certification of veterinary or animal related acupuncture. (3) The licensee may, as a part of the 30 continuing education unit reactivation requirement, complete at least 5 continuing education units directly related to the certification of veterinary or animal related acupuncture. D. The Board shall maintain a registry of all: (1) Licensed acupuncturists certified by the Board as qualified to practice acupuncture on animals; and (2) Animal acupuncture training programs that the Board approves. E. On or after the effective date of this regulation, unless the person is certified by the Board as qualified to practice acupuncture on animals, an individual may not: (1) Represent to the public that the individual is an animal acupuncturist; and (2) Practice acupuncture on animals. F. Exception to Certification. This regulation does not apply to an individual who practices acupuncture on an animal under a research protocol which has been approved by an Animal Use and Care Committee as provided in 9 CFR Ch. 1, Part 2, Subpart C, §§2.30—2.38. G. Violation of this regulation constitutes unprofessional conduct and may result in disciplinary action as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland. #### Regulation .07 Auricular Detoxification Specialist. *COMAR 10.26.02.07* A. Qualification. To qualify as an auricular detoxification specialist, an applicant shall be a certified or licensed practitioner in the State as one of the following health care professionals who works directly with chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients: (1) A certified professional counselor—alcohol and drug; (2) A certified associate counselor—alcohol and drug; (3) A supervised counselor—alcohol and drug; (4) A licensed clinical alcohol and drug counselor; (5) A licensed nurse; (6) A licensed psychologist who works directly with chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients; or (7) A licensed certified social worker—clinical who works directly with the chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients. B. A practitioner that is a medical doctor shall obtain a medical acupuncture certification specific to physicians in accordance with COMAR 10.32.15. C. Registration. The Board shall maintain a registry of all certified auricular detoxification specialists. To apply for certification with the Board as an auricular detoxification specialist, an applicant shall: (1) Provide documentation of successful completion of a Board and NADA approved training program that consists of a minimum 70-hour basic training of which 40 hours are clinical training which includes the following training and subject matter: (a) At least 5 treatments during a 10-minute period with good point location and techniques; (b) The uses and limitations of the treatment; (c) Communal treatment effect and maintaining an appropriate atmosphere; (d) Clean needle technique; (e) The limited scope of practice of auricular detoxification and other ethical principles; (f) The implications of the role of auricular acupuncture for addition in the larger addition treatment context; (g) Preparation of written chart notes regarding status, treatment given, and patient response; (h) Adjunctive nature of auricular acupuncture for addiction and the importance of collaboration and communication with the treatment team; (i) The psycho-spiritual nature of recovery and the ability to respect and support the client's individual beliefs and cognitive process; (j) Methods to modify treatment appropriately and to respond to adverse clinical situations should they occur; (k) Sensitivity, compassion, and respect for clients; and (l) Understanding of addictions from the perspective of basic concepts of East Asian medicine; (2) Complete an application provided by the Board; (3) Provide the name and address of the acupuncturist licensed by the State who shall supervise the applicant; (4) Provide verification of active licensure in good standing in the State from the appropriate Health Occupations Board; (5) Provide verification that an applicant works in a State-approved professional setting that specializes in the treatment of addiction; and (6) Pay the registration fee in COMAR 10.26.01.03. D. Certification Renewal. (1) A certified practitioner shall renew their certification every 2 years. (2) As part of the renewal, the practitioner shall provide proof to the Board of: (a) Licensure in the approved health profession; (b) Employment working directly with chemically dependent clients of a chemical dependency program in the counseling or treatment of those clients; (c) Employment working in a State-approved setting, working with chemically dependent patients of a chemical dependency program in the counseling or treatment of those patients; and (d) Completion of three continuing education units relevant to the practice of auricular detoxification and the counseling or treatment of chemically dependent patients. (3) At least 1 month before a certification expires, the Board shall send a renewal notice to an auricular detoxification specialist that states: (a) The date the current certification expires; (b) The date the renewal application is to be received by the Board for the renewal to be issued before the certification expires; and (c) The amount of the renewal fee. (4) Before a certification expires, a practitioner certified to perform auricular detoxification may renew the certification if the individual submits: (a) A completed renewal application in the format required by the Board; and (b) Verification from the appropriate Health Occupation Board under §A of this regulation, that confirms that the individual has a current certification or license in good standing; and (c) The renewal fee specified in COMAR 10.26.01.03. (5) An individual registered to perform auricular detoxification shall maintain a current address and telephone number with the Board. (6) A practitioner listed on the registry to perform auricular detoxification: (a) May not practice using any other name than the name on their certification; and (b) Shall immediately inform the Board of any name change. E. Certification Reinstatement. An auricular detoxification specialist holding an expired certification may apply for reinstatement if the individual: (1) Completes an application for reinstatement approved by the Board; (2) Submits the auricular detoxification specialist registration reinstatement fee specified in COMAR 10.26.01.03; and (3) Submits proof of completion of at least three continuing education units directly related to the certification. F. Supervision. The Board may approve a Maryland licensed acupuncturist for supervision of a practitioner on the registry to perform auricular detoxification if the licensee: (1) Holds an active license in good standing to practice acupuncture in Maryland; (2) Has completed a training program in auricular detoxification as set forth in §C of this regulation; and (3) Submits to the Board a completed application in the format provided by the Board. G. Supervisor Responsibilities. A supervisor shall ensure that: (1) Auricular detoxification specialists are sufficiently competent in the areas listed in §C(1) of this regulation; (2) The supervised auricular detoxification specialist and the Board are notified if the supervisor cannot or is unwilling to fill the role of supervisor; and (3) An on-site visit with the auricular detoxification specialist occurs at least once annually before renewal to: (a) View the setting where services are being provided; and (b) Observe at least five treatments, within an hour, performed according to the NADA group protocol. H. Setting. The clinical substance abuse program or professional setting where an individual performs auricular detoxification on patients with documented substance abuse concerns shall meet best practices within community healthcare standards. I. Complaints. (1) The Board may investigate a complaint filed against an auricular detoxification specialist or the supervising licensed acupuncturist. (2) The Board may withdraw the certification of the auricular detoxification specialist or take action against the license of the supervising acupuncturist if either individual violates an applicable law, regulation, or standard of practice while performing auricular detoxification. #### Regulation .08 Acupoint Injection Therapy. *COMAR 10.26.02.08* A. Registration. To obtain the required registration from the Board as qualified to practice acupoint injection therapy, an applicant shall: (1) Possess an active license in good standing to practice acupuncture and East Asian medicine in the State; (2) Successfully complete an NCCAOM, or other appropriate accreditation body endorsed specialty training program and assessment in acupoint injection therapy that consists of at least 60 hours including: (a) A minimum of 40 hours of theoretical training in the required topics; (b) A minimum of 20 hours of live face-to-face clinical practical experience; and (c) Instruction that meets the requirements of §C of this regulation; (3) Possess a current certification by the American Heart Association or approved equivalent in basic life support; (4) Hold a current Clean Needle Technique Certificate through CCAHM or NCCAOM; (5) If licensed in the State for less than 2 years, possess a valid license in good standing to practice acupuncture and East Asian medicine, in any state, for at least 2 years before applying to perform acupoint injection therapy in the State; and (6) Complete and submit an application in the format provided by the Board. B. The Board shall accept the documentation from a licensee that has completed the training required to perform acupoint injection therapy prior to the effective date of this regulation if: (1) The licensee provides a certificate, or other valid documentation, confirming successful completion of 60 hours of acupoint injection therapy training that complies with this regulation; or (2) The previously completed training does not meet the requirements of this regulation, but the licensee provides documentation of completion of supplemental training that, together with the initial training, fulfills the coursework requirements of §C of this regulation. C. Training Program Curriculum. The curriculum for the acupoint injection therapy program shall include: (1) 20 hours of clinical practice on a patient or patients; (2) History and development of acupuncture injection therapy; (3) Differential diagnosis; (4) Definitions, concepts, and pathophysiology; (5) The nature, function, channels entered, and contraindications of the substances stated in §F(2) of this regulation; (6) Diseases amenable to treatment with acupuncture injection therapy and the substances appropriate to treat them; (7) Identification of appropriate points for treatment, including palpatory diagnosis; (8) A review of physical examination, anatomy, and referral zones; (9) Universal precautions including management of blood borne pathogens and hazardous waste; (10) Procedures for injections, including preparing the substances, contraindications, and precautions; (11) Administration techniques and equipment required; (12) Administration of the prepackaged substances authorized for acupoint injection therapy, including aseptic technique, recordkeeping and storage of substances prepared and authorized for use in acupoint injection therapy; (13) Safety and emergency procedures; and (14) 2 hours of training in the use of intramuscular epinephrine and emergency oxygen which count toward the required theoretical and clinical training hours. D. Clinical Instructors. In addition to the requirements of NCCAOM, or other appropriate accreditation body, an instructor for acupoint injection therapy shall: (1) Ensure that the curriculum meets the training requirements set forth under §C of this regulation; (2) Be a licensed practitioner in acupuncture in good standing in the State and be registered to practice acupoint injection therapy in the State; (3) Possess at least 5 years of experience in the practice of acupuncture that includes acupoint injection therapy; (4) Retain proof of compliance as set forth under this section for as long as they provide acupoint injection therapy training; and (5) Provide proof of compliance to the Board upon request. E. Training Programs. All training programs shall provide each successful student with: (1) A certificate of successful completion of the program; (2) A course syllabus outlining the schedule and curriculum of the program; and (3) Testing requirements and the performance measure for successful completion. F. Practice. (1) To practice acupoint injection therapy, the licensed acupuncturist shall: (a) Possess a registration for acupoint injection therapy from the Board; (b) Explain acupoint injection therapy to the patient in advance of treatment; (c) Obtain written informed consent specific to acupoint injection therapy that shall be included in the patient’s medical record; (d) Only perform subcutaneous, intradermal, or intramuscular injection in accordance with the principles of acupuncture; (e) Have an adverse event or emergency plan in place for allergic reactions to injected substances; (f) Maintain professional liability coverage for this procedure; and (g) Only use prepackaged and sterile acupoint injectable therapeutic substances that are: (i) Acquired from an appropriately licensed entity in compliance with federal and State law; and (ii) Stored securely and in accordance with manufacturer's specifications. (2) In the practice of acupoint injection therapy, the licensed acupuncturist, provided they have been trained on utilization of the specific therapeutic substance, may only use the following therapeutic substances for acupoint injection therapy: (a) Sterile and bacteriostatic water; (b) Saline solution; (c) Alkalizing agents such as sodium bicarbonate; (d) Nutritional or dietary substances; (e) Vitamins and minerals including B-12, B-complex, C, cyanocobalamin, hydroxocobalamin, and methylcobalamin; (f) Proteins, enzymes, and amino acids including methionine, choline, inositol, and glutathione; (g) Sugars including dextrose and glucose; (h) Ozone; (i) Procaine and lidocaine; (j) Herbal and botanical extracts including astragalus and Sarapin; (k) Biological products including hyaluronic acid and epinephrine; and (l) Homeopathic substances including Traumeel and Zeel. (3) A licensed acupuncturist in the practice of acupoint injection therapy may not: (a) Administer substances other than those specified under §F(2) of this regulation; (b) Administer substances that the licensed acupuncturist has not been appropriately trained in accordance with this regulation; (c) Give an injectable substance to a patient for self-injection; or (d) Administer intravenous injections. G. The Board shall maintain a list of all: (1) Licensed acupuncturists registered by the Board as qualified to practice acupoint injection therapy; and (2) Acupoint injection therapy training programs endorsed by the NCCAOM, or other appropriate accreditation body updated at least annually. H. On or after the effective date of this regulation, unless the person is registered by the Board as qualified to practice acupoint injection therapy, an individual may not: (1) Practice acupoint injection therapy; or (2) Represent to the public that the individual is an acupoint injection therapy registered acupuncturist. I. Violation of this regulation constitutes unprofessional conduct and may result in disciplinary action as set forth in Health Occupations Article, §4-315, Annotated Code of Maryland. #### Regulation .09 Name Under Which a Licensee May Practice. *COMAR 10.26.02.09* A. A licensee shall be licensed to practice acupuncture only under the name indicated on the license. B. A licensee wishing to change the name under which the licensee practices shall obtain prior Board approval. C. The failure of a licensee to practice under the name on the license may: (1) Result in a fine; or (2) Be considered unprofessional conduct by the Board and constitute grounds for disciplinary action. ### Chapter 03 — Code of Ethics **Authority:** Health Occupations Article, §§1A-205 and 1A-206, Annotated Code of Maryland **Administrative History:** Effective date: October 18, 1999 (26:21 Md. R. 1630) **Administrative History:** Regulation .03C amended effective October 1, 2001 (28:19 Md. R. 1685); February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .06G, H adopted effective April 11, 2005 (32:7 Md. R. 681); February 16, 2026 (53:3 Md. R. 122) #### Regulation .01 Scope. *COMAR 10.26.03.01* This chapter does not apply to an individual who practices acupuncture on an animal under an animal research protocol which has been approved by an Animal Use and Care Committee as provided in 9 CFR §§2.30 — 2.38. #### Regulation .02 Definitions. *COMAR 10.26.03.02* A. In this chapter, the following term has the meaning indicated. B. Term Defined. “Board” means the State Board of Acupuncture. #### Regulation .03 Standards of Practice. *COMAR 10.26.03.03* A. The licensee shall be concerned primarily with the welfare of the patient or client. B. A licensee who suffers from a physical, mental, or emotional impairment, including chemical abuse, which impacts the licensee's ability to practice acupuncture shall seek professional treatment and refrain from the practice of acupuncture until such time as the impairment no longer exists or reasonable accommodations can be made. C. A licensee shall: (1) Use professional discretion and integrity in relationships with a member of the health care community; (2) Be professional in conduct, with honesty, integrity, self-respect, and fairness; (3) Remain free from a conflict of interest while fulfilling the objectives and maintaining the integrity of the acupuncture profession; (4) Provide accurate fee information to the patient, the individual responsible for payment for treatment, and the insurer; (5) At all times respect the patient's dignity, autonomy, and privacy; (6) Practice acupuncture only as defined in the scope of practice set forth in Health Occupations Article, §1A-205, Annotated Code of Maryland; (7) Cooperate with an investigation conducted by the Board, including: (a) Furnishing information requested, (b) Complying with a subpoena, (c) Responding to a complaint at the request of the Board, and (d) Providing meaningful and timely access to relevant patient records; and (8) Report to the Board or other appropriate authority conduct in the practice of acupuncture that indicates a violation of: (a) This chapter; (b) Health Occupations Article, Title 1A, Annotated Code of Maryland; or (c) Other federal or State laws. D. A licensee may not: (1) Misrepresent the licensee's credentials, qualifications, or affiliations and shall attempt to correct others who misrepresent the licensee's credentials, qualifications, or affiliations; (2) Knowingly engage in or condone behavior which is fraudulent, dishonest, or deceitful, or involves moral turpitude; (3) Engage in a commercial activity which conflicts with the licensee's duties as a licensed acupuncturist; (4) Perform acupuncture on a patient if the contraindication against acupuncture treatment exists; or (5) Discriminate against a patient or a health care provider based on race, religion, age, gender, sexual orientation, national origin, or disability. #### Regulation .04 Relationship with Patient. *COMAR 10.26.03.04* A. A licensee shall: (1) Use professional judgement in the use of evaluation and treatment procedures; (2) Decline to administer treatment if the licensee believes that the treatment is contraindicated or unjustified; (3) Terminate a professional relationship with patient in an appropriate manner, such as: (a) Providing the patient with sufficient notice to permit the patient to obtain the services of another professional, (b) Assisting the patient by providing referrals if appropriate, or (c) Continuing to provide emergency treatment to the patient if treatment is required before a reasonable time has passed to allow the patient to obtain the services of another health care provider; (4) Maintain a written record of treatment of the patient under the licensee's care for at least 5 years after the termination of treatment; (5) Make the records available to the patient on request, in compliance with applicable laws for disclosure of medical records; (6) Make arrangements for another professional to provide for the needs of the patient during an anticipated absence when the licensee is unavailable to a patient; (7) Make a referral only to other qualified and duly licensed health care providers; (8) Accurately inform a patient, a health care professional, and the public of the limitations of the practice of acupuncture and make a referral to an appropriate health care practitioner as needed; (9) Adequately assess the patient to determine whether a contraindication against acupuncture treatment exists before beginning treatment; (10) Exercise independent professional judgement in the treatment and evaluation of a patient, regardless of whether the patient was referred by another health care provider; and (11) Provide full notice to the patient that the patient would not reasonably be expected to benefit from the treatment. B. A licensee may not: (1) Accept a client for treatment, or continue unnecessary treatment, when the patient cannot be reasonably expected to benefit from the treatment; (2) Receive remuneration from, or split a fee for, either making or accepting a referral of the patient to another health care practitioner; (3) Make a guarantee or promise about the efficacy of a particular treatment, the licensee's practice, or the result of a treatment unless supported by scientific principles accepted by the profession; or (4) Exploit the professional relationship by: (a) Continuing treatment unnecessarily; (b) Charging for a service: (i) Not provided, or (ii) Different from those actually provided. #### Regulation .05 Professional Boundaries. *COMAR 10.26.03.05* A. The licensee shall: (1) Maintain professional boundaries, even when the patient initiates crossing the boundaries of the professional relationship; (2) Respect and maintain professional boundaries and respect the patient's reasonable expectation of professional conduct; and (3) If the licensee and the patient mutually desire a personal relationship, immediately terminate the professional relationship, make an appropriate referral to another health care practitioner, and wait before engaging in such a relationship for a time when it is reasonably certain that the professional relationship has no influence on the personal relationship. B. The licensee may not: (1) Exploit a relationship with a patient for the licensee's personal advantage, including, but not limited to, a personal, sexual, romantic, or financial relationship; (2) Engage in a sexually intimate act with a patient; or (3) Engage in sexual misconduct which includes behavior in which a licensee has engaged in sexual behavior with a patient in the context of a professional evaluation, treatment, procedure, or other service to the patient, regardless of the setting in which the professional service is provided. #### Regulation .06 Records, Confidentiality, and Informed Consent. *COMAR 10.26.03.06* A licensee shall: A. Respect and maintain the privacy and confidentiality of the patient; B. Disclose the patient's record or information about the patient only with the patient's consent or as required by law; C. Adequately safeguard confidential patient information, including storage and disposal of records; D. Provide sufficient information to a patient to allow the patient to make an informed decision regarding treatment, including: (1) The purpose and nature of an evaluation or treatment regimen, (2) Alternatives to treatment, (3) Side effects and benefits of a treatment regimen proposed and alternatives to that treatment, (4) The estimated cost of treatment and alternatives to treatment, (5) The right of the patient to withdraw from treatment at any time, including the risks associated with withdrawing from treatment, and (6) The patient's right to decline to participate in treatment if an aspect of the treatment will be recorded, documented, photographed, observed, or otherwise used in an educational program; E. Obtain the full informed consent of a patient participating in a human research program, without a direct or implied penalty for the patient's refusal to participate in the program, and with due regard for the patient's autonomy and dignity; F. Comply with applicable federal and State laws for human research programs; G. Maintain all patients' records in English; and H. If requested by the Board, provide an English language translation of the records by a Board approved translator, at the licensee's expense. #### Regulation .07 Education and Training. *COMAR 10.26.03.07* A. The licensee shall: (1) Recognize the licensee's limitations and qualifications and practice acupuncture within the limits of these limitations and qualifications; (2) Obtain additional training, information, and supervision as needed to perform a new technique or service in a new specialty area or when employing a new treatment modality; and (3) Be current in the licensee's qualifications to practice acupuncture, including meeting continuing education requirements established by the Board. B. The licensee may not perform a treatment or provide a service which the licensee is not qualified to perform or which is beyond the scope of the licensee's education, training, capabilities, experience, and scope of practice. #### Regulation .08 Advertising. *COMAR 10.26.03.08* A. A licensee may advertise services subject to the provisions of this regulation. B. A licensee may not use statements in an advertisement that: (1) Contain a misrepresentation of facts; (2) Are likely to mislead or deceive because, in context, the statement makes only a partial disclosure of relevant facts; (3) Intend to or are likely to create a false or unjustified expectation of a favorable result; (4) Relate to fees, other than a standard consultation fee or a range of fees for specific types of services, without fully disclosing all relevant variables so that the statement would not be misunderstood or be deceptive to a layman; (5) Convey the impression that the licensee could improperly influence a public body, official, corporation, or a person on behalf of a patient; (6) Contain a representation that the licensee is willing to perform a procedure which is illegal; or (7) Contain a representation or implication that, in reasonable probability, can be expected to cause an ordinarily prudent person to misunderstand or be deceived. C. A licensee is accountable under this regulation if the licensee uses an agent, partnership, professional association, or health maintenance organization to implement an action prohibited by this regulation. #### Regulation .09 Ethical, Legal, and Professional Responsibilities. *COMAR 10.26.03.09* The licensee may not construe the failure to specify a particular ethical, legal, or professional duty in this chapter as a denial of the existence of other ethical, legal, or professional duties or responsibilities that are equally as important and generally recognized in the profession. ### Chapter 04 — Rules of Procedure for Board Hearings **Authority:** Health Occupations Article, §§1A-205, 1A-309, 1A-310, and 1A-314;State Government Article, §10-206; Annotated Code of Maryland **Administrative History:** Effective date: July 22, 2002 (29:14 Md. R. 1075) **Administrative History:** Chapter revised effective February 20, 2012 (39:3 Md. R. 259) **Administrative History:** Regulation .02B amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .05C amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .10B amended effective February 16, 2026 (53:3 Md. R. 122) **Administrative History:** Regulation .12 amended effective April 13, 2015 (42:7 Md. R. 569) #### Regulation .01 Scope. *COMAR 10.26.04.01* This chapter governs procedures for disciplinary matters and hearings before the State Acupuncture Board and establishes the standards for use as a guide for the imposition of disciplinary sanctions against any Maryland licensed acupuncturist or any registered auricular detoxification specialist if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §1A–309, Annotated Code of Maryland, to place a licensee or registered auricular detoxification specialist on probation, reprimand, suspend, fine, or revoke a license. The Board may consider aggravating and mitigating factors in determining sanctions. #### Regulation .02 Definitions. *COMAR 10.26.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative law judge” means the hearing officer assigned to preside over a hearing in cases which the Board has delegated to the Office of Administrative Hearings. (2) “Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board. (3) “Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board. (4) “Advisory letter” means an informal action consisting of a nonpublic letter issued by the Board if the Board has a basis to charge the licensee with disciplinary violations, but closes the case by advising the licensee of the laws governing the practice of acupuncture. (5) “Board” means the State Acupuncture Board. (6) “Board counsel” means the attorney assigned by the Office of the Attorney General to provide legal advice to the Board, and to represent the Board in legal matters and suits filed against and on behalf of the Board. (7) “Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board. (8) “Case resolution conference committee” means a committee composed of members of the Board who make recommendations to the Board regarding settlement of disciplinary matters. (9) “Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board, ordering a licensee to cease from doing a specified activity or an unlicensed individual to cease the unauthorized practice of acupuncture. (10) “Charging document” means a nonpublic document issued by the Board which: (a) Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Acupuncture Act; (b) Sets forth sections of the Maryland Acupuncture Act the Board believes were violated; and (c) Provides notice to the licensee of disciplinary proceedings before the Board. (11) Complaint. (a) “Complaint” means a written document received by the Board which sets out conduct by a licensee which may violate the Maryland Acupuncture Act and which may be grounds for an investigation or disciplinary action by the Board. (b) “Complaint” includes, but is not limited to: (i) A consumer complaint; (ii) A law enforcement report; (iii) A report from a hospital or related institution; (iv) A report from another state, country, or jurisdiction, or from the armed services of the United States; (v) A report from an insurer; (vi) A malpractice insurance report; (vii) An advertisement; (viii) A news article or report; (ix) A webpage or other published content; (x) A report from a professional association, peer review committee, rehabilitation committee, or medical review committee as defined in Health Occupations Article, §14-501, Annotated Code of Maryland; (xi) A report from another health occupation board or other State agency; (xii) A report from a court of this or another jurisdiction; (xiii) An application filed with the Board; (xiv) A written memorandum of the Board alleging conduct by a licensee; and (xv) Other information, from any other source, which warrants investigation. (12) “Complaint review committee” means the committee composed of Board members, Board staff, Board counsel, the administrative prosecutor, and other individuals designated by the Board to: (a) Review complaints; (b) Recommend to the Board that a matter be referred for investigation; (c) Recommend to the Board that a matter be closed; (d) Recommend to the Board that a licensee be charged with a violation of the Maryland Acupuncture Act or of an order of the Board; (e) Recommend to the Board that the Board solicit a response from a licensee or respondent before further action; and (f) Make recommendations to the Board regarding any other disciplinary matter which has been delegated to the complaint review committee by the Board. (13) “Consent agreement” means informal action taken by the Board consisting of a nonpublic document which has been negotiated and agreed to by both the licensee and the Board to resolve an administrative, nondisciplinary matter. (14) “Consent order” means a public document issued by the Board which is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter. (15) “Contested case” means a proceeding conducted under State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (16) “Disposition agreement” means a formal nonpublic agreement, entered into with an impaired licensee instead of formal disciplinary action, in which the licensee agrees to comply with certain conditions. (17) “Final order” means a public document issued by the Board resolving a contested case either by consent or after an adjudication and which includes findings of fact, conclusions of law, and a disposition which: (a) Denies a license; (b) Sanctions by reprimand, probation, fine, or suspension or revocation of a license; (c) Summarily suspends a license; (d) Dismisses charges; (e) Surrenders a license; or (f) Takes any other action that the Board is authorized to do by law. (18) “Imperatively requires emergency action” means a finding by the Board that an emergency action must be taken against a licensee under State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held. (19) “Informal action” means that the Board closes a case, without taking any formal disciplinary action or issuing a final order, by imposing a disciplinary sanction consisting of: (a) A letter of education; (b) An advisory letter; (c) A letter of admonishment; (d) A cease and desist letter; or (e) A consent agreement. (20) “Investigation” means the gathering of information about an applicant or after the Board receives a complaint against a licensee, which is necessary for the Board to determine whether there is reasonable cause to deny an application or charge a licensee with a violation of the Maryland Acupuncture Act. (21) Letter of Admonishment. (a) “Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board, either before or after charges have been issued, if the Board believes a licensee has engaged in conduct which violates the Maryland Acupuncture Act but closes the case by admonishing the licensee. (b) “Letter of admonishment” may reflect agreement by the Board and the licensee that the licensee shall perform certain conditions instead of the Board taking formal disciplinary action. (22) “Letter of education” means informal action consisting of a nonpublic letter: (a) Issued by the Board if the Board does not believe that conduct rose to the level of a violation of the Maryland Acupuncture Act; and (b) In which the Board educates the licensee of the laws and standards of the practice of acupuncture. (23) “Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender licensure to practice acupuncture, and which may include conditions for the Board's acceptance of the surrender as a resolution of the case instead of the Board taking formal disciplinary action. (24) “Licensee” means an individual who is licensed to practice acupuncture in Maryland. (25) “Licensure” means the authority granted to an individual by the Board pursuant to the Board's authority under the Maryland Acupuncture Act to practice acupuncture in this State. (26) “Maryland Acupuncture Act” means Health Occupations Article, Title 1A, Annotated Code of Maryland. (27) “Notice of initial denial” means a nonpublic document issued by the Board: (a) By which an applicant or licensee is notified that the Board intends to deny a license, or a change in licensure status, or some other benefit sought by the licensee, and of the statutory grounds or other reasons for the denial; and (b) Which provides notice to the licensee of any proceedings scheduled before the Board. (28) “Post-deprivation hearing” means a contested case hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension. (29) “Predeprivation hearing” means a nonevidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why the Board should not: (a) Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or (b) Take some other action which the Board is authorized by law to take. (30) “Preliminary investigation” means the gathering of information necessary for the Board to determine whether the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Acupuncture Act. (31) “Probation” means a sanction imposed by the Board in a public final order by which the public is notified that the licensee has violated the Maryland Acupuncture Act and the licensee is monitored by the Board for a period of time and must comply with certain conditions in order to avoid further disciplinary action. (32) “Prohibited act” means any conduct specified in the Maryland Acupuncture Act which can result in sanctions or penalties. (33) “Public document” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland. (34) “Recommended decision” means a nonpublic document issued to the Board by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, and a proposed sanction, or any combination of these. (35) “Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or another reason which may interfere with the Board member's participation in a case. (36) “Registered auricular detoxification specialist” means an individual who has been registered by the Board for the purpose of assisting an individual who is undergoing detoxification to remove addictive substances from the body and to restore health. (37) “Respondent” means a licensee, subject to the jurisdiction of the Board, who has been: (a) Charged with a violation of Health Occupations Article, §1A-309, Annotated Code of Maryland; (b) Notified that the Board intends to initially deny a license, change a licensee's status, or deny some other benefit sought by the licensee; (c) Notified of a potential emergency suspension of the licensee's license; or (d) Otherwise notified that the licensee has the opportunity to appear before the Board to respond to allegations by the Board in a contested case. (38) “Reprimand” means a sanction imposed by the Board in a public final order if the Board determines that the licensee has violated the Maryland Acupuncture Act, which: (a) Does not place the licensee on a period of probation; (b) Permits the licensee to continue practicing without license suspension; and (c) May be imposed in addition to any other sanctions authorized by the Act. (39) “Revocation” means a sanction imposed by the Board in a public final order if the Board determines that the licensee has violated the Maryland Acupuncture Act, which terminates the licensee's authority to practice acupuncture and renders the licensee an unlicensed individual. (40) “Sanction” means an action taken against a licensee by the Board in a public final order by which the public is notified that the licensee has violated the Maryland Acupuncture Act, and which may consist of a reprimand, probation, suspension or revocation of the license, or a fine. (41) “Show cause hearing” means a nonevidentiary hearing held before the Board in which a licensee has an opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board is legally authorized to take. (42) “Stay” means the withholding of an action ordered by the Board and which may be subject to certain conditions. (43) “Stet” means the act of suspending all action in a proceeding, which may be subject to certain conditions, and which the Board has the discretion to reopen at a later time. (44) “Summary suspension” means the indefinite suspension of a license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, issued if the Board believes the action is necessary to protect the public health, safety, or welfare. (45) “Surrender” means the voluntary relinquishing of a license to practice acupuncture which may be subject to certain conditions set by the Board. (46) “Suspension” means a sanction imposed by the Board in a public final order if the Board determines that a licensee has violated the Maryland Acupuncture Act, which temporarily discontinues the licensee's authority to practice acupuncture for a specific period of time or until certain conditions are met. #### Regulation .03 Confidentiality of Proceedings. *COMAR 10.26.04.03* A. Except as otherwise provided by law, the proceedings of the Board are confidential. The confidentiality may not be waived by the parties. B. Office of Administrative Hearing proceedings involving the adjudication of a Board contested case and the administrative law judge's recommended decision are confidential, and the respondent may not waive the confidentiality of the proceedings or of the patients whose medical records or care are reflected in the record of the proceedings. C. To the extent possible, both before and after a final order is entered into by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board's order. #### Regulation .04 Representation by Counsel. *COMAR 10.26.04.04* A. A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings. B. If the matter goes to a hearing, a respondent shall be represented by the respondent, or by an attorney who is admitted to the Maryland Bar or specially admitted to practice law pursuant to Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland. C. An administrative prosecutor assigned to the Board by the Office of the Attorney General shall prosecute disciplinary matters in Board proceedings. D. The Board may be represented by and obtain advice of counsel assigned to it by the Office of the Attorney General in all proceedings. #### Regulation .05 Proceedings Under Health Occupations Article, §1A-309, Annotated Code of Maryland. *COMAR 10.26.04.05* A. Investigation of Complaints. (1) The Board executive director may make a preliminary review of each complaint and may recommend to the Board that cases involving complaints over which the Board has no jurisdiction be closed. (2) The Board's complaint review committee shall review complaints over which the Board has jurisdiction and make a recommendation to the Board as to the disposition of each complaint. (3) The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee who is the subject of the complaint to obtain a response to the allegations made in the complaint. (4) Participation in review of complaints made to the Board is not ordinarily a basis for recusal of a Board member, Board counsel, or the administrative prosecutor from further proceedings in the case. (5) The Board may issue subpoenas over the signature of the Board's executive director or a Board member. B. Prosecution of Complaint. (1) For each complaint, after reviewing any completed investigative information or reports and considering the recommendation of the complaint review committee, the Board shall: (a) Dismiss the complaint; (b) Close the case; (c) Refer the case to peer review for mediation; (d) Close the case with informal action; (e) Issue a cease and desist order; (f) Refer the matter for further investigation; (g) Refer the matter to the administrative prosecutor; or (h) Vote to: (i) Charge a licensee with a violation of Health Occupations Article, §1A-309, Annotated Code of Maryland; (ii) Consider the matter as a basis for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; (iii) Initially deny licensure or reinstatement of a license; or (iv) Accept the surrender of a license subject to conditions acceptable to the Board. (2) The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, regardless of whether the Board has voted to charge a licensee with a violation of the Maryland Acupuncture Act. C. Charges and Notice of Initial Denial. (1) If the Board issues charges or a notice of initial denial, the document shall be served upon the respondent. (2) Service is completed when the document is: (a) Sent by U.S. first-class mail; (b) Sent by certified mail to the address the respondent is required to maintain with the Board; (c) Hand delivered in-person or by courier; or (d) Sent by electronic means with a read receipt. (3) Charges or a notice of initial denial shall: (a) Inform the respondent of the statutory basis for the charges or denial of licensure; (b) Allege sufficient facts which the Board believes constitute either a basis for: (i) Violation of the Maryland Acupuncture Act; or (ii) Denial of licensure; (c) Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing; and (d) Be accompanied by a letter of procedure notifying the respondent of the applicability of the Administrative Procedure Act to the Board's proceedings. (4) If the respondent has not acknowledged receipt of the charges or notice of initial denial, the Board may nevertheless proceed in prosecuting the case if it has complied with §C(2) of this regulation. (5) If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board. D. Discovery. (1) Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following: (a) A list of the witnesses to be called; (b) Copies of documents intended to be produced at the hearing; or (c) Both §D(1)(a) and (b) of this regulation. (2) Mandatory Discovery. (a) Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier: (i) The name and curriculum vitae of any expert witness who will testify at the hearing; and (ii) A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion. (b) If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert. (c) The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report: (i) At the prehearing conference, if scheduled; or (ii) Immediately before the scheduled hearing. (d) If an expert adopts a sufficiently specific charging document as the expert's report, that adoption shall satisfy the requirements set forth in this section. (3) Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation. (4) Both parties have a continuing duty to supplement their disclosures of witnesses and documents. (5) Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after: (a) The prehearing conference, if scheduled; or (b) 15 days before the hearing, if no prehearing conference is scheduled. (6) The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes. (7) Construction. (a) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and consistent with COMAR 28.02.01; (b) In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies. E. Case Resolution Conference. (1) After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference. (2) At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter. (3) The Board may deny a respondent's request for a case resolution conference except as provided in §E(1) of this regulation. (4) Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source. (5) The Board is not bound by the recommendations of the case resolution conference committee and may: (a) Modify a proposed settlement; (b) Require additional conditions; or (c) Reject the recommendation and require the respondent to proceed to a hearing. (6) If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or notice of initial denial. (7) If either the respondent or administrative prosecutor disagree with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee. (8) Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case. #### Regulation .06 Sanctions, Hearings, and Final Order. *COMAR 10.26.04.06* A. Surrender of License. (1) If a respondent offers to surrender licensure after the initiation of an investigation, before or after service of charges, or instead of any or further disciplinary action, the Board may require conditions for the surrender of the license. (2) The Board may require conditions for surrender of a license, including, but not limited to: (a) The admission of a violation of the Maryland Acupuncture Act; (b) The admission of facts; (c) A statement of the circumstances under which the surrender was offered or accepted; (d) Restrictions on future licensure; (e) Conditions for reinstatement of the license; or (f) An agreement that the respondent may not again apply for reinstatement of the license. (3) A letter of surrender is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland, unless the Board determines that disclosure of the surrender is not in the public interest. B. Hearings on Charges or Notice of Initial Denial. (1) Hearings shall be conducted under State Government Article, Title 10, Annotated Code of Maryland. (2) The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings. (3) Proceedings of the Board delegated to the Office of Administrative Hearings shall be conducted under this chapter. (4) Proceedings are not open to the public and all records, including the recommended decision, shall be treated as confidential and sealed. (5) If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing: (a) Proposed or final findings of fact; (b) Proposed or final conclusions of law; (c) A proposed sanction; or (d) Any combination of §B(5)(a) — (c) of this regulation under the Board's delegation. (6) In proceedings before the Board, the Board's counsel may advise the Board on issues of law in the course of the proceedings. C. Burden of Proof. (1) A licensee against whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has initially denied. (2) The Board has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Acupuncture Act. D. Exceptions and Exceptions Hearing. (1) If a matter has been delegated by the Board to the Office of Administrative Hearings, each party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision. (2) Within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board. (3) Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages. The exceptions shall state with particularity: (a) The findings of fact, conclusions of law, or other matter excepted to; and (b) The relevant portions of the record supporting the party's exception. (4) Within 10 days after a party's exceptions are filed with the Board, the opposing party may file an answer to exceptions. (5) Unless otherwise permitted by the Board, a party's answer to exceptions may not be longer than 25 double-spaced pages, and shall state with particularity a response to an exception and the relevant portions of the record supporting that response. (6) Unless otherwise permitted, the Board may not consider a party's response to an answer to exceptions. (7) Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board following receipt of the parties' exceptions and any answer to exceptions. (8) Exceptions Hearing. (a) An exceptions hearing shall be held before the Board. (b) The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions. (c) The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument. (d) The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing. (e) The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal. (9) Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in exceptions, any answer to exceptions, or in the hearing on exceptions, reference any document or other evidence or offer any exhibit that is outside the record of the evidentiary hearing before either the Board or the administrative law judge. (10) If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision. E. Board Final Decision and Order. (1) After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed. (2) If the hearing followed charges, the Board may order the dismissal of the charges, or, if it determines there has been a violation of the Maryland Acupuncture Act, the Board may order that the licensee be fined, reprimanded, placed on probation, or the license suspended or revoked. (3) If the hearing followed a notice of initial denial of license, the Board may order the grant or denial of a license. (4) Within 15 days after the Board issues a final order, either party may file a motion for reconsideration with the Board, which may be granted at the Board's discretion. (5) There is no automatic right to a hearing on a party's motion for reconsideration, and the Board has the discretion to request a response to the motion from the opposing party. #### Regulation .07 Summary Suspension of a License. *COMAR 10.26.04.07* A. Under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board may order the summary suspension of a license if it determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare. B. Notice of Intent to Summarily Suspend. (1) Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue: (a) A notice of an intent to summarily suspend a license; or (b) An order of summary suspension. (2) If the Board votes to issue a notice of an intent to summarily suspend a license or an order of summary suspension, it shall refer the matter to the administrative prosecutor for prosecution. (3) A notice of intent to summarily suspend a license shall include, but is not limited to: (a) A proposed order of summary suspension which is unexecuted by the Board and which includes: (i) The statutory authority on which the action has been taken; (ii) Allegations of fact which the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and (iii) Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and (b) An order or summons to appear before the Board to show cause why the Board should not execute the order of summary suspension and which notifies the respondent of the consequences of failing to appear. (4) Service. (a) The Board shall serve a respondent with a notice of intent to summarily suspend a license not later than 5 days before a predeprivation show cause hearing is scheduled before the Board. (b) Service of the notice of intent to summarily suspend shall be made: (i) Personally upon the respondent; (ii) By certified mail to the address the respondent is required to maintain with the Board; or (iii) By any other reasonable means to effect service. (c) If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed in prosecuting the case. C. Predeprivation Opportunity To Be Heard. (1) If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before it executes the order of summary suspension. (2) A Predeprivation Show Cause Hearing before the Board. (a) The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension. (b) The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument. (c) The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing. (d) The respondent and the administrative prosecutor shall each be limited to 30 minutes in which to present oral argument. (e) The respondent shall proceed first and may reserve part of the allotted time for rebuttal. (3) The Board member who presides over the hearing: (a) May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious when the presiding Board member believes that the documents or exhibits are necessary in order for a fair hearing; and (b) May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing. (4) The members of the Board may be recognized by the presiding member to ask questions of either party appearing before the Board. D. Summary Suspension of a License without Prior Notice or an Opportunity To Be Heard. (1) In extraordinary circumstances, the Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend the license or providing a respondent with an opportunity for a predeprivation hearing if: (a) The Board determines that the public health, safety, or welfare requires the immediate suspension of the license and that prior notice and an opportunity to be heard is not feasible; (b) The order of summary suspension is served upon the respondent within 24 hours after its execution; and (c) The respondent is provided with an opportunity for a hearing before the Board within 15 days after the effective date of the summary suspension. (2) If the respondent requests a hearing under §D(1)(c) of this regulation, the hearing shall be conducted before the Board as provided in §C(2) of this regulation and shall provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license. E. Burdens of Production and Persuasion. (1) In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrates that the public health, safety, or welfare is not at risk. (2) The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the public health, safety, or welfare imperatively requires the Board to summarily suspend the respondent's license. F. Disposition. (1) If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to: (a) Order a summary suspension; (b) Deny the summary suspension; (c) Enter into an order agreed upon by the parties; or (d) Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (2) If the Board orders a summary suspension before a show cause hearing, it may, at the conclusion of the hearing, vote to: (a) Affirm its order of summary suspension; (b) Rescind the order for summary suspension; (c) Enter into an order agreed upon by the parties; or (d) Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (3) An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings are final orders of the Board and public records under State Government Article, §10-611, Annotated Code of Maryland. G. Post-Deprivation Opportunity for an Evidentiary Hearing. (1) If the Board orders the summary suspension of a license under §C or D of this regulation, the respondent may have an evidentiary hearing before the Board or before an administrative law judge, if the Board delegates the matter to the Office of Administrative Hearings. (2) The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension. (3) Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after respondent's request. (4) An evidentiary hearing may be consolidated with a hearing on charges issued by the Board which include the facts which form the basis for the summary suspension. (5) An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (6) If the Board has delegated the matter to the Office of Administrative Hearings, the administrative law judge shall issue to the Board a recommended decision with: (a) Proposed or final findings of fact; (b) Proposed or final conclusions of law; (c) A proposed disposition; or (d) Any combination of §G(6)(a) — (c) of this regulation under the Board's delegation of the matter to the Office of Administrative Hearings. (7) If the hearing is one combined with charges, the administrative law judge's determination as to the merits of the summary suspension shall be based only on those parts of the record that were available to the Board at the time it voted for the summary suspension. (8) The parties may file exceptions to the recommended decision as provided in State Government Article, §10-216, Annotated Code of Maryland. (9) An order issued by the Board after a post-deprivation evidentiary hearing is a final order of the Board and is a public record under State Government Article, §10-611, Annotated Code of Maryland. #### Regulation .08 Probation and Violation of Probation Proceedings. *COMAR 10.26.04.08* A. If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board determines to be appropriate, including: (1) Reeducation or completion of approved courses; (2) Payment of a fine; (3) Donation to an approved institution providing acupuncture services for the poor, indigent, or handicapped; (4) Providing free acupuncture services in a Board-approved program; (5) Entering into and complying with a contract with an addiction treatment program; (6) Practice supervision; (7) Monitoring by the Board or by an individual or entity chosen or approved by the Board and periodic reporting to the Board; (8) Periodic review of a licensee's clinical practice; (9) Periodic review or audit, or both, of a licensee's billing practices; (10) An examination by a physician or appropriate health care provider; (11) Limitation of the licensee's practice; (12) Achieving a passing score on an appropriate examination; or (13) Any other condition the Board determines to be appropriate for the rehabilitation or retraining of a licensee. B. A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee. C. A licensee seeking termination of probation shall do so only by petitioning the Board for probation: (1) When the specific period of time has passed; or (2) After the licensee has successfully completed the conditions or acts required for termination. D. If at any time the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall: (1) Charge the licensee with a violation of probation; (2) Take any action provided for in the final order or consent order in the event of a violation of probation, including suspension of the license; (3) Consider a summary suspension of the license; or (4) Take any other action the Board considers appropriate and which it is authorized to do by law. E. Charges for Violation of Probation. (1) If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter. (2) The charging document for a violation of probation shall: (a) Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order which the Board believes has been violated; (b) Allege facts which the Board believes constitute a basis for a violation of probation; and (c) Notify the respondent of: (i) Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and (ii) The consequences of failing to appear for those proceedings or to request a hearing. (3) If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter. F. Violation of Probation Hearing. (1) Unless otherwise determined by the Board, a hearing for a violation of probation shall be held before the Board. (2) The hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the charge that the licensee has violated probation. (3) The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument. (4) The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing. (5) The respondent and the administrative prosecutor shall each be limited to 30 minutes in which to present oral argument. (6) The respondent shall proceed first and may reserve part of the allotted time for rebuttal. (7) The Board member who presides over the hearing: (a) May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious when the Board member believes that the documents or exhibits are necessary in order for a fair hearing; and (b) May not allow testimony by any witness, unless the parties agree and the Board approves before the hearing. (8) The members of the Board may be recognized by the presiding member to ask questions of either party appearing before the Board. (9) If the Board believes that the issues in the case warrant it, the Board may provide a respondent with an evidentiary hearing, either before the Board or an administrative law judge if the Board delegates the matter to Office of Administrative Hearings, which may be instead of or after a nonevidentiary violation of probation hearing held before the Board. (10) The Board may consider the complexity of the case, the need for testimony or admission of other evidence, or any other factor it considers appropriate in determining whether to provide a respondent with an evidentiary violation of probation hearing. (11) An evidentiary hearing shall be conducted under the contested case provisions of the Administrative Procedure Act. G. After a hearing, the Board shall issue a final order consisting of findings of fact, conclusions of law, and an order that is a public record under State Government Article, §10-611, Annotated Code of Maryland. H. If the Board determines that respondent has violated probation, the Board may: (1) Take any action provided for in the consent order or final order in the event of a violation of probation; (2) Impose additional conditions of probation; or (3) Impose any sanction or take any other action that the Board considers appropriate and is authorized to do by law. #### Regulation .09 Reinstatement of a License. *COMAR 10.26.04.09* A. Petition for Reinstatement. (1) A licensee who seeks reinstatement after suspension, revocation, or surrender of a license, or whose reinstatement involves a disciplinary issue, shall petition the Board for reinstatement. (2) The Board may not consider a petition for reinstatement after the revocation of a license before 1 year after the effective date of the revocation, unless otherwise specified in the final order. (3) A licensee who petitions the Board for reinstatement under terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board shall apply for reinstatement only under those terms and conditions. (4) A licensee whose license has been revoked or surrendered for 3 or more years before filing a petition for reinstatement is not eligible for reinstatement but may apply for an initial license. (5) In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall: (a) File an application for reinstatement with the Board; (b) Meet the requirements for reinstatement set out in COMAR 10.26.02; and (c) Maintain completion of required continuing education credits as if the licensee had been continually licensed. B. Notice of Intent to Deny Reinstatement and Opportunity for a Hearing. (1) If the Board issues a notice of intent to deny reinstatement, service shall be as provided for in Regulation .05C(1) and (3) of this chapter. (2) A notice of intent to deny reinstatement shall: (a) Inform the applicant of the Board's legal basis for the Board's belief that the respondent is not qualified for reinstatement, including any applicable statutory provision; (b) Allege any facts which the Board believes supports the Board's reasons for denying reinstatement; and (c) Notify the respondent of: (i) Any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time; and (ii) The consequences of failing to appear for those proceedings or to request a hearing. (3) If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board shall, before the hearing, provide the applicant with a case resolution conference to discuss settlement of the matter as provided in Regulation .05E of this chapter. (4) A hearing on the notice of denial of reinstatement shall be held before the Board or be delegated to an administrative law judge and conducted under the contested case provisions of the Administrative Procedure Act. C. If the Board grants reinstatement of a license, the Board may impose any restrictions or conditions on the license or the licensee's practice that the Board considers appropriate. #### Regulation .10 Sanctioning Guidelines. *COMAR 10.26.04.10* A. General Application. (1) This regulation shall be used by the Board as a guide for sanctioning licensees pursuant to its authority under Health Occupations Article, §§1A-205 and 1A-309, Annotated Code of Maryland, for violations of the Acupuncture Act and the Board's regulations. (2) The Board is not required to make findings of fact with respect to any of the factors for determining the sanction indicated by the sanctioning guidelines. (3) A departure from the sanctioning guidelines alone is not a ground for any hearing or appeal of a Board action. (4) Notwithstanding these sanctioning guidelines, in order to resolve a disciplinary matter, the Board and the licensee or registered detoxification specialist may agree to surrender a license or registration or to a Consent Order with terms, conditions, and sanctions agreed upon. (5) In a case where there are multiple and distinct violations, the Board may impose a sanction greater than the maximum indicated by the sanctioning guidelines for each individual violation. (6) If probation is imposed, the Board may impose appropriate terms and conditions of probation, and, if a licensee or registration holder violates the terms or conditions of probation, the Board may take further disciplinary action against the individual. (7) In the event a violation does not fall within the sanction range, the Board shall so indicate and use its best judgment to determine the appropriate sanction and shall consider, to the extent possible, the factors in the sanctioning guidelines. B. Range of Sanctions. C. Mitigating and Aggravating Factors. Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside of the range of sanctions established by the guidelines. These factors may include, but are not limited to the following: (1) Mitigating Factors: (a) Absence of a prior disciplinary record; (b) The licensee reported the violation to the Board; (c) The licensee voluntarily admitted violation, provided full disclosure to the Board, and cooperated during Board proceedings; (d) The licensee implemented remedial measures to correct or mitigate harm arising from the violation; (e) The licensee made a timely good-faith effort to make restitution or otherwise rectify the consequences of the violation; (f) Evidence of rehabilitation or potential for rehabilitation; (g) Absence of premeditation to commit the violation; (h) Absence of potential harm to or adverse impact on the public; (i) Isolated incident and not likely to recur; and (j) The licensee’s prior community service and present value to the community. (2) Aggravating Factors: (a) Previous criminal or administrative disciplinary history; (b) The violation was committed deliberately or with gross negligence or recklessness; (c) The violation had the potential for, or caused, serious patient harm; (d) The violation was part of a pattern of detrimental conduct; (e) The licensee was motivated to perform the violation by his or her financial gain; (f) The vulnerability of the patient; (g) The licensee attempted to conceal the violation, falsified or destroyed evidence, or presented false testimony or evidence; (h) The licensee failed to cooperate with the Board’s investigation; and (i) Previous attempts at rehabilitation were unsuccessful. #### Regulation .11 Judicial Review. *COMAR 10.26.04.11* A final order of the Board is subject to judicial review as provided in Health Occupations Article, §1A-311, and State Government Article, §10-222, Annotated Code of Maryland. #### Regulation .12 Imposition of Penalties. *COMAR 10.26.04.12* A. The Board may impose a civil monetary penalty instead of or in addition to a disciplinary sanction authorized by Health Occupations Article, §1A-309, Annotated Code of Maryland. B. Practicing on an Expired License. (1) The Board may impose a civil fine against an acupuncturist who practices acupuncture on an expired license in the amount of $100 per day not to exceed $5,000. (2) The Board may not impose a fine under §B(1) of this regulation against an acupuncturist for practicing acupuncture on an expired license if the acupuncturist’s license is reinstated within 30 calendar days of the expiration date of the license and the licensee complies with COMAR 10.26.02.05D. C. Practicing Without a License or Misrepresentation. (1) The Board may impose a civil fine of no less than $5,000 and no more than $50,000 against an individual who practices acupuncture without a license or represents to the public, by description of services, methods, or procedures, or otherwise, that the individual is authorized to practice acupuncture in this State. (2) Factors determining the amount of the fine include, but are not limited to, the following: (a) The extent to which the individual derived any financial benefit from the unauthorized practice; (b) The willfulness of the unauthorized practice; (c) Actual or potential harm caused by the unauthorized practice; (d) The length of time in which the individual engaged in the unauthorized practice; and (e) The cost of any Board investigation. #### Regulation .13 Consideration and Notice of Board Files. *COMAR 10.26.04.13* In any matter governed by this chapter, the Board may consider or take official notice, or both, of any information contained in the Board's files. #### Regulation .14 Hearing Costs. *COMAR 10.26.04.14* A. If, after a hearing, a licensee is found to have violated provisions of Health Occupations Article, §1A-309, Annotated Code of Maryland, the Board shall impose a fee on the licensee that shall approximate the Board's cost of bringing the proceedings against the licensee. B. The hearing costs may include any or all of the following expense items: (1) Services rendered by court reporters; (2) Transcriptions of the hearing record by court reporters; (3) Expenses related to witnesses appearing for the State; (4) Obtaining or reproducing documents, exhibits, or other evidentiary items; (5) Hearing-related per diems and expenses for Board members; or (6) Any other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee. ### Chapter 05 — Compelling Purpose Disclosure **Authority:** State Government Article, §10-617(h)(3), Annotated Code of Maryland **Administrative History:** Effective date: October 1, 2001 (28:19 Md. R. 1685) #### Regulation .01 Disclosure for Compelling Public Purpose. *COMAR 10.26.05.01* The Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns: A. Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority; B. A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or C. Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges. #### Regulation .02 Other Disclosures. *COMAR 10.26.05.02* This chapter does not prohibit or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information which the Board may otherwise disclose by law. ### Chapter 06 — Continuing Education **Authority:** Health Occupations Article, §§1A-205 and 1A-306, Annotated Code of Maryland **Administrative History:** Effective date: October 16, 2023 (50:20 Md. R. 887) #### Regulation .01 Scope. *COMAR 10.26.06.01* This regulation governs all acupuncturists licensed to practice in the State of Maryland. #### Regulation .02 Definitions. *COMAR 10.26.06.02* A. In this chapter, the following term has the meaning indicated. B. Term Defined. “Board” means the State Board of Acupuncture. #### Regulation .03 Licensure Renewal. *COMAR 10.26.06.03* A. A licensee applying for renewal shall complete 30 hours of relevant continuing education during the 2-year period preceding the expiration of the license which include the following: (1) At least 20 hours in formally organized programs approved by the Board which are relevant to the practice of acupuncture and East Asian medicine; (2) Not more than 10 hours of formally organized training programs in Western science and medical practices, medical ethics, medical research, or cardiopulmonary resuscitation which are relevant to the practice of acupuncture and East Asian medicine; (3) Not more than 10 hours of training in approved programs which will assist a licensee to carry out the licensee’s professional responsibilities, including, but not limited to: (a) Management courses for a school administrator; (b) Foreign language training for translators of relevant texts; or (c) Educational methodology for teachers of acupuncture; (4) Not more than 10 hours teaching acupuncture and related East Asian medical therapies in an accredited school or in a program approved for acupuncture continuing education; (5) Not more than 7 hours of pro bono work as outlined in §B of this regulation; (6) Not more than 7 hours in published writing or articles in acupuncture and East Asian medicine that are: (a) Peer-reviewed research or peer-reviewed clinically relevant articles in acupuncture and East Asian medicine; and (b) Limited to 4 hours per article; (7) Not more than 20 hours for passage of the NCCAOM exam within the 2-year period preceding the expiration of the license; or (8) Not more than 10 hours serving on a professional board involving: (a) Acupuncture; or (b) East Asian medicine. B. Pro Bono Work. (1) Pro bono work shall: (a) Earn 1 credit hour for each 3 hours of pro bono activity up to a maximum of 7 credit hours per renewal cycle; and (b) Be for the provision of acupuncture services provided through an organization offering humanitarian services such as, but not limited to: (i) Domestic or international victims in an emergency situation or disaster area; (ii) Low-income or underserved areas or populations; (iii) Special needs populations; or (iv) United States military personnel. (2) Upon completion of the pro bono work, the licensee shall obtain from the facility written documentation of completion of pro bono hours, including: (a) The name of the facility; (b) The address where the pro bono work was provided; (c) The type of work that was done; (d) The number of hours of actual work provided for which the licensee desires credit hours; and (e) A statement guaranteeing that the work provided no financial benefit to the licensee. C. Licensees shall maintain the documentation of their continuing education credits for 4 years from the date of their acupuncture renewal. D. If requested by the Board, a licensee shall provide proof of continuing education attendance by providing documentation of: (1) Name of the program; (2) Date of the program; (3) Number of continuing education hours earned; and (4) Name of the sponsoring organization. ## Subtitle 27 — Board of Nursing ### Chapter 01 — Examination and Licensure **Authority:** Health Occupations Article, §§1-213, 1–230, 8-101, 8-201, 8-205, 8-206, 8-301—8-315, 8-6A-05(a), 8-701, 8-7A-01, Article 1116(b)(2), and 8-703; Tax-General Article, §§10-738 and 10-739(b)(1); Annotated Code of Maryland; Ch. 486, Acts of 2012; Chs. 281 and 282, Acts of 2013; Chs. 385 and 386, Acts of 2016; and Chs. 234 and 234, Acts of 2017 **Administrative History:** Effective date: **Administrative History:** Regulation .01B, C amended effective May 5, 1978 (5:9 Md. R. 684) **Administrative History:** Regulation .02A amended effective January 7, 1976 (3:1 Md. R. 40) **Administrative History:** Regulation .02B, F amended effective October 13, 1976 (13:21 Md. R. 1206) **Administrative History:** Regulation .02G amended effective May 14, 1975 (2:10 Md. R. 752) **Administrative History:** Regulation .05 amended effective January 7, 1976 (3:1 Md. R. 40) **Administrative History:** Regulation .08 repealed effective March 23, 1979 (6:6 Md. R. 512) **Administrative History:** Regulations .01—.07 renumbered as Regulations .02, .03, .04, .05, .07, .08, and .09, respectively **Administrative History:** Regulation .01 adopted effective March 23, 1979 (6:6 Md. R. 512) **Administrative History:** Regulation .02A, C, E, G, H amended effective March 23, 1979 (6:6 Md. R. 512) **Administrative History:** Regulation .02B, C amended effective June 29, 1979 (6:13 Md. R. 1128) **Administrative History:** Regulations .03A—F, H and .05A amended effective March 23, 1979 (6:6 Md. R. 512) **Administrative History:** Regulation .06 adopted effective March 23, 1979 (6:6 Md. R. 512) **Administrative History:** Regulations .08A, C and .09 amended effective March 23, 1979 (6:6 Md. R. 512) **Administrative History:** Regulations .01—.09 repealed effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulations .01—.11 adopted effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulations .01—.06 amended as an emergency provision effective April 11, 1994 (21:9 Md. R. 744); amended permanently effective August 15, 1994 (21:16 Md. R. 1384) **Administrative History:** Regulation .01B amended effective December 11, 1989 (16:24 Md. R. 2620); May 10, 1993 (20:9 Md. R. 779) **Administrative History:** Regulation .02A amended effective December 11, 1989 (16:24 Md. R. 2620); October 1, 1990 (17:19 Md. R. 2321); May 10, 1993 (20:9 Md. R. 779) **Administrative History:** Regulation .02A amended as an emergency provision effective July 1, 1991 (18:14 Md. R. 1606); adopted permanently effective January 2, 1992 (18:25 Md. R. 2751) **Administrative History:** Regulation .02A amended as an emergency provision effective October 27, 1995 (22:23 Md. R. 1795); amended permanently effective February 12, 1996 (23:3 Md. R. 169) **Administrative History:** Regulation .02A amended as an emergency provision effective November 14, 1997 (24:25 Md. R. 1717); amended permanently effective March 9, 1998 (25:5 Md. R. 369) **Administrative History:** Regulation .02A amended as an emergency provision effective August 2, 1999 (26:17 Md. R. 1314); amended permanently effective November 15, 1999 (26:23 Md. R. 1777) **Administrative History:** Regulation .04D adopted effective November 8, 1993 (20:22 Md. R. 1707) **Administrative History:** Regulation .06G amended as an emergency provision effective November 1, 1987 (14:23 Md. R. 2412); adopted permanently effective March 1, 1988 (15:3 Md. R. 304) **Administrative History:** Regulation .06G amended effective May 10, 1993 (20:9 Md. R. 779) **Administrative History:** Regulation .07 amended effective October 1, 1990 (17:19 Md. R. 2321); May 10, 1993 (20:9 Md. R. 779) **Administrative History:** Regulation .07A amended effective December 11, 1989 (16:24 Md. R. 2620); November 8, 1993 (20:22 Md. R. 1707) **Administrative History:** Regulation .08E adopted effective October 1, 1990 (17:19 Md. R. 2321) **Administrative History:** Regulation .09 amended as an emergency provision effective October 27, 1995 (22:23 Md. R. 1795); amended permanently effective February 12, 1996 (23:3 Md. R. 169) **Administrative History:** Regulation .09C amended effective May 10, 1993 (20:9 Md. R. 779) **Administrative History:** Regulation .10 amended effective December 11, 1989 (16:24 Md. R. 2620) **Administrative History:** Regulation .10D amended and H adopted effective October 1, 1990 (17:19 Md. R. 2321) **Administrative History:** Regulation .10I adopted effective May 10, 1993 (20:9 Md. R. 779) **Administrative History:** Regulation .11 recodified to Regulation .12 and new Regulation .11 adopted effective December 11, 1989 (16:24 Md. R. 2620) **Administrative History:** Regulation .13 adopted effective December 11, 1989 (16:24 Md. R. 2620) **Administrative History:** Regulations .14 and .15 adopted effective May 10, 1993 (20:9 Md. R. 779) **Administrative History:** Chapter revised effective April 30, 2001 (28:8 Md. R. 760) **Administrative History:** Regulation .01B amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .01B amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .01B amended effective September 22, 2008 (35:19 Md. R. 1717) **Administrative History:** Regulation .01C adopted effective September 22, 2008 (35:19 Md. R. 1717) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective April 1, 2013 (40:6 Md. R. 474) **Administrative History:** Regulation .02A amended effective September 3, 2001 (28:17 Md. R. 1556); August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .03 amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .03A amended effective September 22, 2008 (35:19 Md. R. 1717) **Administrative History:** Regulation .04 amended effective September 22, 2008 (35:19 Md. R. 1717) **Administrative History:** Regulation .04B amended effective September 3, 2001 (28:17 Md. R. 1556) **Administrative History:** Regulation .05 amended effective March 1, 2004 (31:4 Md. R. 316); September 27, 2004 (31:19 Md. R. 1433) **Administrative History:** Regulation .05A amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .05D amended effective September 22, 2008 (35:19 Md. R. 1717) **Administrative History:** Regulation .05I adopted as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .09A amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .09A amended effective January 6, 2014 (40:26 Md. R. 2164) **Administrative History:** Regulation .09D adopted as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .11 amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .11 amended effective April 19, 2010 (37:8 Md. R. 617) **Administrative History:** Regulation .12 amended effective April 1, 2013 (40:6 Md. R. 474) **Administrative History:** Regulation .12F, G amended effective April 24, 2006 (33:8 Md. R. 733) **Administrative History:** Regulation .12H adopted effective October 11, 2004 (31:20 Md. R. 1485) **Administrative History:** Regulation .12I, J, K adopted as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .12I amended effective April 19, 2010 (37:8 Md. R. 617) **Administrative History:** Regulation .12I-1, I-2, J-1 adopted effective April 19, 2010 (37:8 Md. R. 617) **Administrative History:** Regulation .12I-1 amended effective June 13, 2011 (38:12 Md. R. 705) **Administrative History:** Regulation .13 amended as an emergency provision effective January 2, 2007 (34:4 Md. R. 397); amended permanently effective May 7, 2007 (34:9 Md. R. 825) **Administrative History:** Regulation .13A amended effective April 24, 2006 (33:8 Md. R. 733) **Administrative History:** Regulation .13C amended effective January 6, 2014 (40:26 Md. R. 2164) **Administrative History:** Regulation .15 amended effective April 24, 2006 (33:8 Md. R. 733) **Administrative History:** Regulation .16 amended effective April 19, 2010 (37:8 Md. R. 617) **Administrative History:** Regulation .17C amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Chapter revised effective February 13, 2017 (44:3 Md. R. 189) **Administrative History:** Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667); June 17, 2019 (46:12 Md. R. 544); August 23, 2021 (48:17 Md. R. 669); Regulation .01B amended as an emergency provision effective January 4, 2022 (49:4 Md. R. 297); emergency status expired effective July 3, 2022 **Administrative History:** Regulation .01B amended as an emergency provision effective September 7, 2022 (49:21 Md. R. 940); emergency status expired effective March 5, 2023 **Administrative History:** Regulation .01B amended as an emergency provision effective May 4, 2023 (50:10 Md. R. 405); emergency status expired effective October 31, 2023 **Administrative History:** Regulation .01B amended as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); amended permanently effective October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .01B amended effective April 27, 2026 (53:8 Md. R. 356 **Administrative History:** Regulation .01D adopted effective August 23, 2021 (48:17 Md. R. 669) **Administrative History:** Regulation .02 amended effective January 29, 2018 (45:2 Md. R. 69); July 1, 2025 (52:10 Md. R. 436) **Administrative History:** Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03A, C amended as an emergency provision effective January 4, 2022 (49:4 Md. R. 297); emergency status expired effective July 3, 2022 **Administrative History:** Regulation .03C amended as an emergency provision effective September 7, 2022 (49:21 Md. R. 940); emergency status expired effective March 5, 2023; Regulation .03C amended as an emergency provision effective May 4, 2023 (50:10 Md. R. 405); emergency status expired effective October 31, 2023 **Administrative History:** Regulation .03C amended as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); amended permanently effective October 13, 2025 (52:20 Md. R. 1001) **Administrative History:** Regulation .05 amended effective July 2, 2018 (45:13 Md. R. 667); April 27, 2026 (53:8 Md. R. 356) **Administrative History:** Regulation .05C amended effective August 23, 2021 (48:17 Md. R. 669) **Administrative History:** Regulation .05C amended as an emergency provision effective October 6, 2023 (50:22 Md. R. 972); emergency status expired effective April 3, 2024 **Administrative History:** Regulation .05C amended effective June 24, 2024 (51:12 Md. R. 619) **Administrative History:** Regulation .06F repealed effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .09D, F amended effective July 2, 2018 (45:13 Md. RR. 667) **Administrative History:** Regulation .10 amended effective August 28, 2017 (44:17 Md. R. 835); July 2, 2018 (45:13 Md. R. 667); August 23, 2021 (48:17 Md. R. 669); April 27, 2026 (53:8 Md. R. 356) **Administrative History:** Regulation .11 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .12 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .13 amended effective July 2, 2018 (45:13 Md. R. 667); June 17, 2019 (46:12 Md. R. 544) **Administrative History:** Regulation .13N amended as an emergency provision effective June 24, 2025 (52:15 Md. R. 810); amended permanently effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .14 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .15B amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .16E amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .17C adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 297); emergency status expired effective July 3, 2022 **Administrative History:** Regulation .17C adopted as an emergency provision effective September 7, 2022 (49:21 Md. R. 940); emergency status expired effective March 5, 2023 **Administrative History:** Regulation .17C amended as an emergency provision effective May 4, 2023 (50:10 Md. R. 405); emergency status expired effective October 31, 2023 **Administrative History:** Regulation .17C adopted as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); adopted permanently effective October 13, 2025 (52:20 Md. R. 1001) #### Regulation .01 Definitions. *COMAR 10.27.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Active nursing practice” as used in Health Occupations Article, §8-312, Annotated Code of Maryland, means: (a) The practice of registered nursing or licensed practical nursing as defined in Health Occupations Article, §8-101, Annotated Code of Maryland; (b) Related nursing activities approved by the Board, including but not limited to a generic nursing education program, degree completion programs, or graduate programs within the last 5 years; and (c) Completion of a generic nursing education program, degree completion program, or a graduate program within the last 5 years. (2) “Advanced practice registered nurse” has the meaning stated in Health Occupations Article, §8-101, Annotated Code of Maryland. (3) “Biennial renewal” means renewal of a license every 2 years in the licensee’s birth month. (4) “Board” means the Maryland Board of Nursing. (5) “Central Repository” means the Maryland Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services. (6) “Certified nursing assistant (CNA)” has the meaning stated in Health Occupations Article, §8-6A-01, Annotated Code of Maryland. (7) “Continuing education” means planned, organized learning experiences designed to augment the knowledge, skill, and ability to enhance nursing practice and therefore improve health care delivered to the public. (8) “Continuing education unit (CEU)” means 1 contact hour of 50—60 minutes. (9) “Cosign” means a registered nurse verifies that: (a) An activity was performed safely and accurately by the nursing graduate; and (b) The documentation is complete and accurate. (10) “Criminal history records check” means the performance of both a State criminal history check by the Central Repository, and a national criminal history check by the Federal Bureau of Investigation (FBI). (11) “Criminal history records information” means information provided by the criminal history records check regarding an applicant's criminal arrests, charges, and convictions, and other dispositions of criminal charges. (12) “Direct patient care” means healthcare activities that involve direct interaction between a healthcare professional and a patient. (13) “Endorsement” means, for qualified applicants who have an unencumbered license from another state or country to practice registered nursing or licensed practical nursing, a waiver of the initial licensure requirement to take the national licensure examination in accordance with Health Occupations Article, §8-307, Annotated Code of Maryland. (14) “English language competency examination” means an examination that tests an individual’s written and oral competency in the English language. (15) Entry-level Registered Nursing Education Program. (a) “Entry-level registered nursing education program” means a registered nursing education program that is the initial entry point for formal registered nursing education that, upon successful completion, qualifies an individual with no prior registered nursing education to obtain licensure as a registered nurse. (b) “Entry-level registered nursing education program” does not include degree completion programs, including but not limited to: (i) Associate of Applied Science Degree in Nursing to Baccalaureate of Science Degree in Nursing (AAS-BSN); (ii) Associate of Degree in Nursing to Baccalaureate of Science Degree in Nursing (ADN-BSN); (iii) Associate of Applied Science Degree in Nursing to Masters of Science Degree in Nursing (AAS-MSN); (iv) Associate Degree in Nursing to Masters of Science Degree in Nursing (ADN-MSN); (v) Baccalaureate of Science Degree in Nursing to Masters of Science Degree in Nursing (BSN-MSN); (vi) Baccalaureate of Science Degree in Nursing to Doctor of Philosophy (BSN-PHD); (vii) Baccalaureate of Science Degree in Nursing to Doctor of Education (BSN-EDD); (viii) Baccalaureate of Science Degree in Nursing to Doctor of Nursing Practice (BSN-DNP); (ix) Masters of Science Degree in Nursing to Doctor of Philosophy (MSN-PHD); (x) Masters of Science Degree in Nursing to Doctor of Education (MSN-EDD); (xi) Masters of Science Degree in Nursing to Doctor of Nursing Practice (MSN-DNP); or (xii) Masters of Science Degree in Nursing to Post Masters Certificate/Post Graduate Certificate. (16) “Former licensee” means an individual who once had an active license with the Board who is no longer active. (17) “Multistate licensure privilege” means an authorization to practice registered nursing or licensed practical nursing in Maryland that is granted to a registered nurse or licensed practical nurse who has an active multistate license issued by another state in accordance with the Nurse Licensure Compact. (18) “NCLEX” means the National Council Licensure Examination for initial licensure as a registered nurse or licensed practical nurse. (19) “Nursing assistant” means an individual certified by the Board as a certified nursing assistant. (20) “Preceptor” means a registered nurse who meets the qualifications of faculty as described in Regulation .16 of this chapter. (21) “Preceptorship” means an individualized refresher course approved by the Board and offered by an institution employing nurses which complies with Regulation .16 of this chapter. (22) “Student” means a registered nurse or licensed practical nurse who is required to complete a refresher course in order to maintain or reestablish an active license. (23) “Substantially equivalent” has the meaning stated in §§C and D of this regulation. (24) “Volunteer” means a licensee who, at the time of licensure renewal, elects to receive a license which only allows the licensee to provide professional services without remuneration. (25) “Written and oral competency in the English language” means the ability to demonstrate proficiency in listening, reading, speaking, and writing the English language. C. “Substantially equivalent” means a registered nursing or licensed practical nursing education program that: (1) Contains theoretical learning experiences and related clinical learning experiences that include direct patient care within various settings consistent with program objectives, outcomes, or competencies conducted either concurrently with or after the theoretical learning experience; and (2) Meets the curriculum requirements for Maryland schools of nursing at the time of the applicant’s graduation, including, but not limited to: (a) The appropriate level of the graduate's intended scope of practice; (b) Didactic and clinical learning experiences that are diverse and consistent with program objectives, outcomes, or competencies; (c) Didactic and clinical instruction in nursing care of families and clients throughout the life span in a variety of care settings requiring nursing measures appropriate for: (i) The maintenance or restoration of mental and physical health; (ii) Preventive, rehabilitative, and curative aspects of health care; (iii) Biophysical, psychosocial, cultural, and spiritual components of health and illness; and (iv) Professional issues content; and (d) Didactic and clinical instructional content that includes, but is not limited to, the areas of: (i) Medical and surgical nursing; (ii) Maternal and child health; (iii) Psychiatric nursing; and (iv) Geriatric nursing. D. “Substantially equivalent” does not mean a registered nurse or licensed practical nursing education program in another state or country that does not have a supervised clinical learning experience requirement. #### Regulation .02 Fees. *COMAR 10.27.01.02* A. The fees listed in this regulation are not refundable. B. Licensure by examination fees are as follows: (1) Registered nurse licensure — $187; (2) Licensed practical nurse licensure — $187; and (3) An examination fee for registered nurse and licensed practical nurse licensure shall be paid by the candidate directly to the testing service. C. Licensure by endorsement fees are as follows: (1) Registered nurse licensure — $230; and (2) Licensed practical nurse licensure — $230. D. Temporary registered nurse or licensed practical nurse licensure fee —$70. E. Advanced practice registered nurse certification fees are as follows: (1) Initial advanced practice certification — $50; and (2) Each additional initial advanced practice certification — $25. F. Specialty nursing practice certification fees are as follows: (1) Initial forensic nurse examiner certification — $25; and (2) Initial workers’ compensation medical case manager certification — $25. G. Biennial renewal fees are as follows: (1) Renewal of a registered nurse license — $165; (2) Renewal of a licensed practical nurse license — $165; (3) Renewal of a registered nurse or licensed practical nurse volunteer license — $73; (4) Renewal of an inactive license for a registered nurse or licensed practical nurse — $60; (5) Renewal of each advanced practice registered nurse certification is in addition to the registered nurse license renewal fee and is — $10; and (6) Renewal of certification for specialty nursing practices regulated by the Board is in addition to the registered nurse license renewal fee and is as follows: (a) Forensic nurse examiner certification — $10; and (b) Workers’ compensation medical case manager certification — $10. H. Health Care Practitioner User Fee. (1) In addition to a license fee, each registered nurse shall pay a non-refundable health care practitioner user fee assessed by the Maryland Health Care Commission in accordance with Health-General Article, §19-111(b)(4), Annotated Code of Maryland. (2) The health care practitioner user fee shall be: (a) Included in the licensing fee paid to the Board; and (b) Collected with the application for an initial or renewal license. (3) The amount of the assessed health care practitioner user fee shall be double the amount of the annual health care practitioner user fee for biennial licensure. (4) The Board shall: (a) Account for the user fees; and (b) Transfer the fees to the Maryland Health Care Commission on a quarterly basis. I. Nurse Practitioner Preceptorship Tax Credit Fund. (1) This fee applies only to nurse practitioners. (2) The Board shall assess a separate $15 fee for the renewal of a nurse practitioner, regardless of the number of certifications held by the nurse practitioner. (3) The Board shall: (a) Account for the fees collected under this section; and (b) Transfer the fee to the Nurse Practitioner Preceptorship Tax Credit Fund. J. Other fees are as follows: (1) Verification of licensure — $45; (2) Copies of transcripts — $25; and (3) Returned check fee —$30. #### Regulation .03 Licensure Exceptions. *COMAR 10.27.01.03* A. Registered nurses or licensed practical nurses who hold a current active license in any other state or jurisdiction may render nursing care: (1) For not more than 30 days, to an individual who is visiting the State for medical, educational, or personal reasons; (2) For the purpose of the interstate transport and care of patients traveling to and from Maryland; and (3) During an emergency situation. B. A registered nurse or licensed practical nurse who holds a multistate licensure privilege under the Nurse Licensure Compact may practice nursing in this State in accordance with the laws of this State. C. Nursing Graduate. (1) A nursing graduate is a graduate of: (a) A Board-approved registered nursing or licensed practical nursing education program; or (b) An out-of-state nursing education program determined to be equivalent by the Board. (2) A nursing graduate may practice as set forth in §C(5)—(7) of this regulation if: (a) The nursing graduate has an application for a license pending before the Board; and (b) One of the following circumstances exists: (i) The nursing graduate has not taken the NCLEX examination; (ii) The nursing graduate has taken the NCLEX examination, but the results of the NCLEX examination are not yet known; (iii) The nursing graduate has taken and passed the NCLEX examination but is waiting for the completion of the criminal history records check; or (iv) The nursing graduate has taken and failed the NCLEX examination but has not failed the NCLEX examination more than one time within the 120 day period immediately following the submission of the application to the Board. (3) A nursing graduate shall cease practice as a nursing graduate: (a) No later than 120 days after the date the nursing graduate submitted an application to the Board; or (b) Immediately if the nursing graduate fails the second NCLEX examination. (4) If the nursing graduate fails the NCLEX examination, the nursing graduate may practice as a nursing assistant provided the individual obtains certification as a nursing assistant and practices according to COMAR 10.39.01. (5) A nursing graduate shall: (a) Practice only under the direct supervision of a registered nurse who is physically present on the unit to: (i) Cosign medication transcription, medication administration, and nursing documentation; and (ii) Continually observe, assist, coordinate, evaluate, and monitor the nursing graduate; and (b) Use the initials “NG” after the nursing graduate's name as credentials. (6) After successful completion of an organized staff development program which includes an evaluation that the nursing graduate is competent and in compliance with §C(5) of this regulation, the nursing graduate may: (a) Transcribe medication orders if: (i) Written policies and procedures are available on the unit of care; and (ii) An organized staff development program which includes skill validation has been successfully completed by the nursing graduate; (b) After competency has been validated by the facility: (i) Administer medications and controlled substances; and (ii) Sign controlled substances sheets; (c) Document in the medical record with the abbreviation “NG”; (d) Perform patient assessments after the initial assessment or after the first assessment of the shift performed by the registered nurse; and (e) Perform and document routine procedures taught within the nursing graduate's generic nursing program, including but not limited to: (i) Placing nasal gastric tubes; (ii) Performing urinary catheterizations; (iii) Applying sterile dressings; (iv) Performing blood sugar checks; and (v) Obtaining specimens. (7) A nursing graduate may not: (a) Work without the physical presence of and direct supervision by a registered nurse; (b) Refer to oneself or practice as a registered nurse (RN) or licensed practical nurse (LPN); (c) Be considered a staff person for purposes of a staffing pattern; (d) Accept charge responsibilities; or (e) Perform initial patient assessment or the first patient assessment of a shift, develop patient plans of care, evaluate or document patient discharge, or independently administer medications or intravenous therapy. #### Regulation .04 General Provisions for Applications. *COMAR 10.27.01.04* A. An applicant shall submit: (1) A completed application to the Board on the form that the Board requires; (2) To a criminal history records check (CHRC) in accordance with Health Occupations Article, §8–303, Annotated Code of Maryland; (3) Written evidence satisfactory to the Board that the applicant has submitted to a CHRC as required by §A(2) of this regulation by submitting: (a) Two sets of fingerprints, as required by the Central Repository and the FBI; and (b) All fees required by the Central Repository and the FBI; (4) Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board: (a) Under Health Occupations Article, §8-303, Annotated Code of Maryland; (b) In an answer to a question on the Board’s application form; or (c) From any other source; and (5) Any additional documentation requested by the Board if the documentation received from the applicant under §A(4) this regulation is incomplete or insufficient. B. If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to: (1) Complete the application; and (2) Provide all information and documents required in §A of this regulation. C. If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board in §A of this regulation within 12 months from the date the application is received by the Board, then the application: (1) Shall be considered abandoned; and (2) May be destroyed. D. Once an application is deemed abandoned under §C of this regulation, an individual seeking licensure shall: (1) Submit a new application; (2) Meet all of the requirements for licensure; and (3) Pay the required fees that are in effect at the time of re-application. #### Regulation .05 Qualifications of Applicants for Examination. *COMAR 10.27.01.05* A. An applicant for the registered nurse licensure examination shall: (1) Complete satisfactorily and meet all requirements for a diploma or degree from an entry-level registered nursing education program approved by the Board (2) Have a diploma or degree from an entry-level registered nursing education program in another state, territory, or country determined by the Board to be substantially equivalent to the registered nursing education program approved in this State at the time of the applicant's graduation. B. An applicant for the licensed practical nurse licensure examination shall: (1) Meet all requirements for a high school diploma or its equivalent and complete satisfactorily and meet all requirements for a diploma from: (a) A licensed practical nursing education program approved by the Board; or (b) A licensed practical nursing education program in any other state, territory, or country determined by the Board to be substantially equivalent to the licensed practical nursing education programs approved in this State at the time of the applicant's graduation; or (2) Meet the requirements of §A of this regulation. C. Applicants for registered nurse licensure and licensed practical nurse licensure who take an English proficiency examination approved by the U.S. Department of Health and Human Services in order to demonstrate English language proficiency under Health Occupations Article, § 8-302(e), Annotated Code of Maryland, shall obtain the minimum passing scores for registered nurses and licensed practical nurses set by the Health Resources and Services Administration of the U.S. Department of Health and Human Services. D. An applicant whose entry-level registered nursing education program or licensed practical nursing education program was completed in another country shall have the applicant's transcript evaluated by the Commission on Graduates of Foreign Nursing Schools or a successor organization. #### Regulation .06 Application for Licensure by Examination. *COMAR 10.27.01.06* A. An applicant shall: (1) Comply with all of the requirements in Regulation .04A of this chapter; (2) File and submit a completed application to the National Council of State Boards of Nursing on the form required; and (3) Pay any required fees. B. Each application shall be signed by the nurse administrator of the school or program or an officer of the school to whom this responsibility has been designated. C. Applications may be signed before graduation and it shall be the responsibility of the person signing the application to submit written verification of program completion before the licensure examination. D. Applicants whose applications are complete and who, for any reason, fail to take the examination within 6 months shall be required to reapply and pay all fees. E. The authorization to test card shall be valid for a period of 6 months. If the applicant fails to complete the examination within that time frame the applicant is required to re-register and pay the NCLEX testing fee. #### Regulation .07 Examination Procedures. *COMAR 10.27.01.07* A. Examinations shall be held at least once per year. B. The Board will participate with the National Council of State Boards of Nursing, Inc., in preparing and administering the National Council Licensure Examination for registered nurse and practical nurse licensure. C. The results of the NCLEX shall be reported as pass or fail. D. An authorization to test card shall be sent to each candidate that the Board determines to be eligible for the examination. E. Examination scores shall be released only to the candidate and to the school of nursing from which the candidate graduated, except on written authorization of the candidate. F. Candidates for Maryland licensure may write the licensure examination in any jurisdiction. G. Candidates applying for licensure in other jurisdictions may write the licensure examination in Maryland. #### Regulation .08 Applicants Requiring Special Accommodation. *COMAR 10.27.01.08* A. An applicant with a disability may request modifications in examination materials or procedures. The applicant shall: (1) Make the request for modifications in writing; (2) Include in the request the following: (a) The candidate's name; (b) The date of the examination to be modified; (c) A letter from the appropriate medical professional which: (i) Confirms the disability; and (ii) Provides information describing the accommodations required; and (d) A letter from the candidate's education program, indicating what modifications, if any, were granted by the program. B. Requests for modification and supporting documentation shall be received by the application deadline. #### Regulation .09 Speech-Impaired Applicants. *COMAR 10.27.01.09* A. An applicant who claims a speech impairment shall fulfill all requirements for application, and shall submit to the Board documentation of the applicant's impairment, from: (1) An otolaryngologist who has current certification from the American Board of Otolaryngology; and (2) A speech-language pathologist who has current certification from the American Speech-Language-Hearing Association. B. The Board shall require a speech-impaired applicant to prove the applicant's ability to communicate adequately with patients and other health care professionals by: (1) Submitting letters from instructors in a nursing program, attesting to the applicant's ability to communicate in a professionally competent manner; and (2) Meeting with the Board to demonstrate the manner in which communication with patients will occur. C. A speech-language pathologist or otolaryngologist may be asked to attend the meeting in an advisory capacity to the Board to aid in assessing an applicant's ability to communicate. D. A foreign-educated, speech-impaired applicant shall notify the Board before taking a Board-approved standardized test for competency in the English language. E. The Board shall attempt to locate a speech-language pathologist fluent in the applicant's native language to assess the impairment. F. A foreign-educated applicant who is in need of foreign accent reduction, but who has competency in the applicant’s native language, may obtain assistance from a bilingual speech-language pathologist before attempting to pass a test for competency in the English language. #### Regulation .10 Licensure by Endorsement. *COMAR 10.27.01.10* A. An applicant who holds an active, unencumbered license to practice registered nursing or practical nursing in another state, territory, or country is eligible for licensure without examination if the applicant: (1) Complies with all of the requirements under Regulation .04A of this chapter; (2) Pays the required fee; (3) Meets one of the conditions in §B of this regulation; and (4) Presents evidence of 1,000 hours of active nursing practice within the last 5 years or successful completion of a Board-approved refresher course or preceptor program. B. An applicant for licensure as a registered nurse by endorsement shall either: (1) Hold a valid, unencumbered multistate license under the Nurse Licensure Compact; or (2) Submit the following evidence directly to the Board from the appropriate authority: (a) Verification that, at the time that applicant graduated from the nursing education program, the nursing education program was: (i) Approved as a registered nursing or licensed practical nursing education program in that state, territory, or country; and (ii) Substantially equivalent to the education program approved in this State; (b) Verification that the applicant passed one of the following licensure examinations under the laws of another state, territory, or country: (i) If completed from 1952 to 1982, the “State Board Test Pool Examination — Registered Nurse or Practical Nurse”; (ii) If completed from 1982 to present, the “National Council Licensure Examination — Registered Nurse or Practical Nurse”; (iii) If completed before, 1952, the “National League for Nursing State-Constructed Board Examination, Registered Nurse or Practical Nurse”; or (iv) If completed before 1982, “Canadian Nurses Association Test Service Examination for Registered Nurses”; (c) For applicants whose entry-level registered nursing education program or licensed practical nursing education program was completed in another country, a copy of an evaluation of the applicant's transcript by the Commission on Graduates of Foreign Nursing Schools or successor organization; and (d) Except as provided in §D(1) of this regulation, proof of written and oral competency in the English language, in accordance with Health Occupations Article, § 8-302(e), Annotated Code of Maryland. C. An applicant for licensure as a registered nurse by endorsement who cannot provide the evidence required under §B(2) of this regulation may qualify for licensure if the applicant submits evidence, as required by the Board, that the applicant has: (1) Completed satisfactorily and met all requirements for an associate or a baccalaureate degree in registered nursing from a college or university that, at the time of the applicant’s graduation, is: (a) Accredited by a national or regional nursing accreditation agency that is recognized by the Secretary of the U.S. Department of Education or the Council for Higher Education Accreditation; and (b) Approved by the board of nursing or other applicable state regulator in the state in which the program is located; and (2) Completed a minimum of 1,000 hours of practice in direct patient care. D. English Language Competency Requirements for Endorsement. (1) An applicant is not required to submit proof of English language competency if the applicant demonstrates that the applicant holds or has held a license to practice registered nursing or licensed practical nursing in another state if that state has an English language competency component for licensure or examination. (2) Applicants for registered nurse licensure and licensed practical nurse licensure who take an English proficiency examination approved by the U.S. Department of Health and Human Services in order to demonstrate English language proficiency under Health Occupations Article, § 8-302(e), Annotated Code of Maryland, shall obtain the minimum passing scores for registered nurses and licensed practical nurses set by the Health Resources and Services Administration of the U.S. Department of Health and Human Services. E. Those applicants who cannot present evidence of 1,000 hours of active nursing practice within the last 5 years, or successful completion of a Board-approved refresher course or preceptor program, may apply for inactive license. #### Regulation .11 Issuance of Licenses. *COMAR 10.27.01.11* A. An initial license shall be issued to each applicant passing the licensure examination or qualifying for licensure by endorsement provided that: (1) The applicant meets all the requirements of this chapter; and (2) The Board has: (a) Received and reviewed the criminal history record information; and (b) Approved the application. B. An initial license may not be issued for less than 90 days. C. An incorrect license issued as a result of a Board error will be corrected in the Board’s data base at no charge to the licensee. D. A licensee who requests a change of name for a license shall: (1) Make the request in writing on the form required by the Board; and (2) Provide appropriate legal documentation supporting the change. #### Regulation .12 Temporary Licensure. *COMAR 10.27.01.12* A. The Board may issue a temporary license to an applicant who passed the licensure examination and is waiting for the criminal history records check to be completed or who is licensed as a registered nurse or licensed practical nurse in any other state provided that the applicant: (1) Completes the required application; (2) If licensed in another state, presents a copy of a current, active license in another state; (3) Presents positive personal identification; (4) Pays the required fee; and (5) Provides written, verified evidence that the applicant has submitted to a criminal history records check in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland. B. Except as provided in §§C and E of this regulation, temporary licenses expire 90 days after date of issuance and are not renewable. C. A temporary license may be extended for an additional 90 days if the applicant is waiting for the completion of the criminal history record information. D. The Board shall revoke a temporary license if the criminal history records check reveals that the applicant has been convicted of or pled guilty or nolo contendere to an act that would be cause for discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland. E. If an applicant does not meet the practice requirement in Regulation .10A(5) of this chapter, a temporary license may be extended every 90 days: (1) Pending completion of the practice requirement; and (2) Provided that the total length of the temporary license does not exceed 12 months from the original date of issuance. #### Regulation .13 Renewal of License. *COMAR 10.27.01.13* A. The Board shall renew the license of a licensee who meets all the requirements of Health Occupations Article, §8-312, Annotated Code of Maryland and of this chapter. B. The Board shall renew licenses biennially according to the following schedule: (1) A registered nurse or licensed practical nurse with an odd-numbered birth year shall always renew in an odd-numbered year not later than the 28th day of the licensee’s birth month; and (2) A registered nurse or licensed practical nurse with an even-numbered birth year shall always renew in an even-numbered year not later than the 28th day of the licensee’s birth month. C. At least 3 months before a license expires, the Board shall send the licensee a renewal notice by: (1) First-class mail to the last known address of the licensee; or (2) Electronic means to the last known electronic address of the licensee. D. It shall be the responsibility of the licensee to notify the Board if a renewal notice is not received. E. The Board cannot guarantee that renewal applications received later than 30 days before the expiration date will be processed before the expiration date. F. The Board shall issue a volunteer license to any registered nurse or licensed practical nurse who meets the licensure renewal requirements provided the licensee: (1) Certifies to the Board that the licensee provides professional services only as a volunteer; (2) Completes the required application; and (3) Pays the required fee. G. Active Licensure Renewal. (1) An individual applying for active licensure renewal shall show evidence of: (a) 1,000 hours of active nursing practice within the 5 years immediately preceding the date of the renewal application; (b) Satisfactory completion of all requirements for a diploma or degree from a Board-approved nursing education program within the 5 years immediately preceding the date of the renewal application; or (c) Completion of 30 continuing education units (CEUs) within the 2 years immediately preceding the date of the renewal application. (2) College or University Coursework. (a) A renewal applicant may submit qualifying college or university coursework to fulfill the requirement under §G(1)(c) of this regulation. (b) 15 CEUs shall be awarded for each semester hour completed of a qualifying college or university course. (c) For the coursework to qualify: (i) The college or university course shall be related to the renewal applicant’s nursing practice; and (ii) The renewal applicant shall receive a grade of C or higher, or the numeric equivalent in the course. (d) An official transcript shall be acceptable as proof of completion of a qualifying college or university course. H. Continuing Education. (1) Except as provided in §G(2) of this regulation, CEUs shall be approved by an entity listed in §H(5) of this regulation. (2) CEUs used for the purpose of renewing a license are subject to random audits by the Board or the Board’s designee. (3) CEUs that are used for the purpose of renewing a license shall be earned within the 2 years immediately preceding the date of the renewal application. (4) The renewal applicant shall be responsible for: (a) Ensuring that a CEU course, forum, or meeting has been approved for CEUs by one of the entities listed in §H(5) of this regulation; (b) Retaining evidence of completed CEUs that are submitted for the purpose of renewing a license for 6 years after the license is renewed; and (c) Producing evidence of completed CEUs for an audit by the Board or the board’s designee within 30 days of the request. (5) The Board shall accept CEUs awarded or approved by: (a) Area Health Education Centers (AHEC), including all local, state, and national centers; (b) The American Nurses Association (ANA); (c) The American Nurses Credentialing Center (ANCC); (d) Professional organizations offering CEUs for the purpose of renewing a national certification for advanced practice registered nursing; (e) A local, state, or national professional nursing association that provides educational programs; (f) The Maryland Nurses Association (MNA); (g) The National Council of State Boards of Nursing; and (h) The National League for Nursing. (6) CEUs may not be carried forward into the next renewal period. I. An individual applying for active licensure renewal who do not meet the requirements of §G of this regulation shall be required to successfully complete a Board-approved refresher program or Board-approved preceptorship program prior to renewal of the license. J. Tax Deficiencies. (1) On a monthly basis, the Board shall notify the Office of the Comptroller of any licensee or certificate-holder: (a) Whose license expires within the next 4-month period; and (b) Whose identity has not previously been provided to the Office of the Comptroller. (2) Upon notification by the Office of the Comptroller of any licensee or certificate-holder who is delinquent in the payment of undisputed taxes or unemployment insurance contributions, the Board shall notify the licensee or certificate-holder that renewal processing shall be delayed until the Office of the Comptroller verifies that the licensee or certificate-holder has made arrangements for payment of the undisputed taxes or unemployment insurance contributions that are satisfactory to the unit responsible for collection. (3) Upon notification by the Office of the Comptroller that the licensee or certificate-holder has made satisfactory arrangements for payment of the undisputed taxes or unemployment insurance contributions, and where the licensee or certificate-holder is otherwise qualified for licensure, the Board shall renew the license or certificate. K. Along with the renewal notice in accordance with §C of this regulation, the Board shall: (1) Notify every renewal applicant who is required to have a criminal history records check in the selected birth month; and (2) Send the renewal applicant instructions for downloading and completing the documents needed to submit to a criminal history records check. L. If a renewal applicant is out of the state, the Board shall mail a packet to the applicant with the required documents and instructions for completing the documents. M. Upon notification by the Board that a criminal history records check is required before a license can be renewed, a renewal applicant shall comply with all of the requirements under Regulation .04A of this chapter. N. Criminal history record checks for renewal applicants shall be scheduled according to the licensee's birth month as follows: (1) In 2025 — all applicants with an August or September birth month; (2) In 2026 — all applicants with a September or October birth month; (3) In 2027 — all applicants with an October or November birth month; (4) In 2028 — all applicants with a November or December birth month; (5) In 2029 — all applicants with a December or January birth month; (6) In 2030 — all applicants with a January or February birth month; (7) In 2031 — all applicants with a February or March birth month; (8) In 2032 — all applicants with a March or April birth month; (9) In 2033 — all applicants with an April or May birth month; (10) In 2034 — all applicants with a May or June birth month; (11) In 2035 — all applicants with a June or July birth month; and (12) In 2036 — all applicants with a July or August birth month. O. For renewal applicants who are required to submit to a criminal history records check, the Board may not renew a license without written documentation that the applicant has submitted to a criminal history record check in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland. #### Regulation .14 Inactive Status. *COMAR 10.27.01.14* A. The Board shall place the license of any registered nurse or licensed practical nurse on inactive status if the licensee: (1) Has not satisfactorily completed 1,000 hours of active nursing practice or graduated from an approved nursing program within the 5-year period immediately preceding the date of anticipated renewal or chooses inactive status; (2) Completes the biennial application for inactive status; and (3) Pays all fees. B. A licensee on inactive status may not practice nursing in this State. However, a registered nurse on inactive status may use the title “registered nurse”, and a practical nurse on inactive status may use the title “licensed practical nurse”. C. A licensee on inactive status may apply for an active status license provided that the licensee: (1) Meets the renewal requirements of Health Occupations Article, §8-312, Annotated Code of Maryland; and (2) Submits to the Board: (a) The required application; and (b) Written, verified evidence that the licensee has submitted to a criminal history records check in accordance with Regulation .13 of this chapter by: (i) Submitting two sets of fingerprints required by the Central Repository and the FBI; and (ii) Paying all fees required by the Central Repository and the FBI. D. An additional fee may not be charged to change from inactive to active status. #### Regulation .15 Expiration of License. *COMAR 10.27.01.15* A. A license expires on the 28th day of the licensee's birth month. B. A licensee has a 30-day grace period beyond the expiration date of a license to renew a license. #### Regulation .16 Refresher Course and Preceptorship Requirements. *COMAR 10.27.01.16* A. Refresher courses and preceptor programs, as defined in Regulation .01B of this chapter, shall be approved by the Board before their implementation and at least every 5 years after that. B. The registered nurse curriculum shall: (1) Have a minimum of 80 theory hours, 60 clinical hours, and 8 hours of a classroom laboratory training before the on-site clinical experience; (2) Include the following content areas: (a) The nursing process; (b) Management and delegation of patient care; (c) Documentation and information management; (d) Pharmacology, including calculation; (e) Nursing care of patients with alterations in body systems; (f) Emergency procedures; (g) Disaster response; and (h) Professional responsibilities, which include, but are not limited to, the following: (i) Trends in nursing and the health care system; (ii) Legal aspects of nursing; and (iii) Development and initiation of patient and community health education. C. The practical nurse curriculum shall: (1) Have a minimum of 60 theory hours, 60 on-site clinical hours, and 8 hours of a classroom laboratory training before the on-site clinical experience; (2) Include the following content areas: (a) The nursing process with the licensed practical nurse as a contributor; (b) Provision and delegation of patient care under the supervision of a registered nurse; (c) Documentation and information management; (d) Pharmacology, including calculations; (e) Nursing care of patients with common health problems; (f) Emergency procedures; (g) Disaster response; and (h) Professional responsibilities, which include, but are not limited to, the following: (i) Trends in nursing; (ii) Legal aspects of nursing; and (iii) Contribution to patient health teaching. D. The organization and utilization of curriculum materials shall be based on accepted educational principles. E. Faculty Qualifications. (1) Faculty shall: (a) Be a registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland; and (b) Have a baccalaureate degree in nursing. (2) A minimum of 3 years of clinical and teaching experience is recommended. F. Faculty shall: (1) Plan, implement, evaluate, and revise the educational program. (2) Select and evaluate clinical facilities used to achieve program objectives. (3) Develop and utilize: (a) Written examinations to measure achievement of program objectives. (b) An evaluation tool to measure achievement of clinical competencies. The clinical competencies shall be based upon the registered nurse and licensed practical nurse standards of practice. (c) A mechanism for student evaluation of the course. G. Students shall complete theoretical instruction either before or concurrent with clinical instruction. H. All program requirements including required clinical hours shall be completed within 12 months of the starting date of the refresher course. I. Clinical facilities shall provide sufficient opportunities to meet the learning objectives of the refresher course. J. The faculty/student ratio may not exceed 1:10 in the clinical area. #### Regulation .17 Reinstatement. *COMAR 10.27.01.17* A. The Board shall reinstate the license of a former licensee who has failed to renew the license for any reason if the former licensee meets the renewal requirements. B. After January 1, 2010, an applicant for reinstatement who has failed to renew the applicant's license for a period of 1 year or more shall submit to a criminal history records check before the license is reinstated. C. Temporary License. (1) The Board shall issue a temporary license to a former licensee who: (a) Applies for reinstatement in accordance with Health Occupations Article, §8-313, Annotated Code of Maryland; (b) Meets the renewal requirements of Health Occupations Article, §8-312, Annotated Code of Maryland; and (c) Is awaiting the completion of the criminal history records check. (2) The temporary license issued pursuant to §C(1) of this regulation is effective until the earlier of 90 days after the date of issue or the date the Board issues an active license. #### Regulation .18 Violation of Regulations. *COMAR 10.27.01.18* A. If a program is thought to be in violation of this chapter, the following steps shall be taken: (1) The Board shall notify the program of the regulations it is violating; (2) The program shall submit a plan with a proposed time frame for correcting the violations; (3) The plan shall be due within 30 days of receipt of notification of the violations; (4) The Board's professional staff may, at the request of the Board, visit the program; (5) After receipt of the plan, the Board shall provide the program with a reasonable time frame within which to correct the violations; and (6) Upon expiration of the time period for correcting violations, a member of the Board's staff shall visit the program to determine if the school is in compliance with the regulations, and report to the Board. B. If the program does not correct the violations within the time frame established by the Board, the Board: (1) Shall notify the program that it has not corrected violations in a reasonable time and schedule a hearing in accordance with the Administrative Procedure Act; and (2) If, after a hearing, determines that the program or preceptorship is in violation of the regulations, may place a program on either conditional approval or remove it from the approved list of programs. If the Board places the program on conditional approval, the Board may request that a program suspend admission of students. A program placed on conditional approval shall remain in that status until the Board determines it has complied with the regulations. C. Unless authorized to practice as a nursing graduate under this chapter, an individual may not use the words “nursing graduate”, the abbreviation “NG”, or any other title, symbol, abbreviation, sign, card, device, or other representation with the intent to represent that the individual practices as a nursing graduate. ### Chapter 02 — Hearing Procedures **Authority:** Health Occupations Article, §§8-205(a)(1), and 8-317, Annotated Code of Maryland **Administrative History:** Effective date: September 30, 1973 **Administrative History:** Regulation .01-1 adopted effective November 23, 1981 (8:23 Md. R. 1857) **Administrative History:** Regulations .01 and .01-1 recodified to .01-1 and .01-2, respectively, and Preface recodified to Regulation .01 Scope, July 1991 **Administrative History:** Regulation .01 amended effective July 3, 1995 (22:13 Md. R. 967); March 14, 2005 (32:5 Md. R. 580) **Administrative History:** Regulation .01-1 repealed and new Regulation .01-1 adopted effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .01-3 adopted effective April 30, 2001 (28:8 Md. R. 760) **Administrative History:** Regulation .02 amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .04 amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .06A amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .06C amended effective March 14, 2005 (32:5 Md. R. 580) **Administrative History:** Regulation .08 amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .09 amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .10 repealed effective July 3, 1995 (22:13 Md. R. 967) #### Regulation .01 Scope. *COMAR 10.27.02.01* These regulations apply only to formal hearings before the Board based on charges or notices of proposed action issued pursuant to Health Occupations Article, §§8-316, 8-404, 8-6A-10, 8-6B-18, 8-6C-20 or 8–6D–10, Annotated Code of Maryland. #### Regulation .01-1 Notice of Hearing. *COMAR 10.27.02.01-1* A. The Board shall send written notice of the hearing to all interested parties at least 30 days before the hearing. B. The Board shall notify the parties of: (1) The date, time, and place of the hearing; (2) A clear and concise statement of the facts asserted; and (3) The charges alleged. C. If the facts cannot be stated in detail when the notice is given, the Board shall state the issues involved. #### Regulation .01-2 Prehearing Conferences. *COMAR 10.27.02.01-2* The Board may set prehearing conferences as it considers appropriate. #### Regulation .01-3 Discovery. *COMAR 10.27.02.01-3* A. Discovery on Request. By written request served on other parties and filed with this Board, a party may require another party to produce, within 15 calendar days: (1) A list of witnesses to be called; and (2) Copies of documents intended to be produced at the hearing. B. Mandatory Discovery. (1) Each party shall provide to the other party the name and curriculum vitae of any expert witness who will testify at the hearing not later than 15 days before the scheduled hearing date. (2) The designation of an expert witness shall be accompanied by a detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion. (3) If the Board finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board shall exclude from the hearing the testimony and any report of the expert. (4) At the hearing, the Board shall consider arguments regarding the sufficiency of the report. (5) If an expert adopts a sufficiently specific charging document as the expert's report, the report satisfies the requirements set forth in this regulation. C. Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation. D. Ongoing Duty of Disclosure. (1) All parties have a continuing duty to supplement their disclosures of witnesses and documents. (2) If witnesses or documents are later added to the list provided under §A of this regulation, each party shall provide notice of these witnesses or documents to the opposing party during business hours at least 1 day before the hearing. (3) The notice requirement referred to in §D(2) of this regulation applies only to witnesses or documents to be used in the party's case-in-chief and not to witnesses or documents to be used for impeachment or rebuttal purposes. #### Regulation .02 Representation. *COMAR 10.27.02.02* A. A party appearing at a formal hearing has the right to appear in proper person or by or with counsel. A party has the right to be accompanied, represented, and advised by counsel. B. Unless authorized to practice law in this State, a counsel may not represent a party before the Board. #### Regulation .03 Records and Transcript. *COMAR 10.27.02.03* A. The Board shall prepare an official record, which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding. B. Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceeding, or part of a proceeding, shall be paid by the party requesting the transcript. #### Regulation .04 Presiding Officer Duties. *COMAR 10.27.02.04* A quorum of the Board shall be present for each formal hearing. The president, or the president's designee, is the presiding officer, and has complete charge of the hearing, permitting the examination of witnesses, admitting evidence, ruling on the admissibility of evidence, and adjourning or recessing the hearing from time to time. #### Regulation .05 Order of Procedure. *COMAR 10.27.02.05* The order in which the parties shall present their case shall be determined by the presiding officer. #### Regulation .06 Examination of Witnesses and Introduction of Evidence. *COMAR 10.27.02.06* A. The rules of evidence in all hearings under these bylaws are as set forth in State Government Article, §§10-213 and 10-214, Annotated Code of Maryland. B. Any party may submit evidence, examine and cross-examine witnesses, and file objections, exceptions, and motions. However, when a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by the counsel. C. The presiding officer, or any person designated by the presiding officer for the purpose, may examine any witness called by any party. The presiding officer may call as a witness any person in attendance at the hearing. Any member of the Board may examine any witness called by any party. #### Regulation .07 Briefs. *COMAR 10.27.02.07* Any party may submit briefs of the issues of fact and law involved in the hearing. The briefs shall be filed in the form, with the number of copies, and at the time that the presiding officer designates. #### Regulation .08 Request for Office of the Attorney General Counsel. *COMAR 10.27.02.08* The Board may request the Office of the Attorney General to participate in any hearing as counsel for the Board. Upon that request, the counsel is entitled to submit evidence and question witnesses on behalf of the Board as permitted by State Government Article, §10-213, Annotated Code of Maryland. #### Regulation .09 Decision and Order. *COMAR 10.27.02.09* The Board shall render every decision and order in writing, which shall be accompanied by findings of fact and conclusions of law. A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or the party's attorney of record. ### Chapter 03 — Nursing Education Programs **Authority:** Health Occupations Article, §§8-205, 8-401, and 8-404, Annotated Code of Maryland **Administrative History:** Effective date: April 16, 1975 (2:8 Md. R. 566) **Administrative History:** Chapter revised effective August 30, 1982 (9:17 Md. R. 1708) **Administrative History:** Regulation .01 amended effective November 21, 1983 (10:23 Md. R. 2064); August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulation .03 amended effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulation .04 amended effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulation .05 amended effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulation .06 amended effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulation .08 repealed and new Regulation .08 adopted effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulation .09 amended effective November 21, 1983 (10:23 Md. R. 2064) **Administrative History:** Regulation .09 repealed and new Regulation .09 adopted effective August 11, 1986 (13:16 Md. R. 1827) **Administrative History:** Regulation .10 amended effective November 21, 1983 (10:23 Md. R. 2064) **Administrative History:** Regulation .13 adopted effective November 21, 1983 (10:23 Md. R. 2064) **Administrative History:** Regulations .01—.13 repealed and new Regulations .01—.20 adopted effective September 30, 1991 (18:19 Md. R. 2100) **Administrative History:** Regulations .01, .06, .07, .09, and .11 amended as an emergency provision effective April 11, 1994 (21:9 Md. R. 745) **Administrative History:** Regulation .01B amended effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulation .06 amended effective August 1, 1994 (21:15 Md. R. 1305); February 12, 1996 (23:3 Md. R. 169) **Administrative History:** Regulation .06A, B amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .07 amended effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulation .09 amended effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulation .11D amended effective August 1, 1994 (21:15 Md. R. 1305) **Administrative History:** Regulations .01—.20, Registered Nursing Education Programs, repealed and new Regulations .01—.19, Nursing Education Programs, adopted effective August 10, 1998 (25:16 Md. R. 1274) **Administrative History:** Chapter revised effective March 5, 2001 (28:4 Md. R. 418) **Administrative History:** Regulation .02G amended effective July 18, 2005 (32:14 Md. R. 1276) **Administrative History:** Regulation .02I amended effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .03A amended effective February 18, 2002 (29:3 Md. R. 220); July 18, 2005 (32:14 Md. R. 1276) **Administrative History:** Regulation .08 amended as an emergency provision effective August 1, 2003 (30:19 Md. R. 1327); amended permanently effective January 5, 2004 (30:26 Md. R. 1915) **Administrative History:** Regulation .08B amended as an emergency provision effective May 23, 2008 (35:13 Md. R. 1178); amended permanently effective August 25, 2008 (35:17 Md. R. 1489) **Administrative History:** Chapter revised as an emergency provision effective November 3, 2008 (35:24 Md. R. 2069); revised permanently effective January 26, 2009 (36:2 Md. R. 101) **Administrative History:** Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667); February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .02 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .03B amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .05 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .07A amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .08 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .08A, C amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .09A amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .11 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .12D, E amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .13 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .14 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .15 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .16 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .17 amended effective February 22, 2021 (48:4 Md. R. 177) **Administrative History:** Regulation .18 amended effective February 22, 2021 (48:4 Md. R. 177) #### Regulation .01 Definitions. *COMAR 10.27.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Approval” means the status granted to a nursing education program that: (a) Is in compliance with the regulations of the Board; and (b) Holds a certificate of approval from the Board of Nursing. (2) “Articulation” means the process by which a registered nurse or licensed practical nurse who is enrolled in a nursing education program is given credit for previous nursing education. (3) “Board” means the Board of Nursing. (4) “Board-recognized nursing accreditation agency (BRNAA)” means a national or regional nursing education accreditation agency recognized by the: (a) Secretary of the United States Department of Education (USDOE); and (b) Board. (5) Clinical Learning Experience. (a) “Clinical learning experience” means faculty planned and guided learning activities designed to assist students to meet the course objectives and apply nursing knowledge and skills in the direct care of patients. (b) “Clinical learning experience” includes: (i) Direct care of patients within the relevant practice setting; (ii) Clinical support activities such as clinical conferences; and (iii) Simulation laboratories. (6) “Clinical nurse faculty” means an individual with at least a baccalaureate degree in nursing who is employed by the program solely for clinical learning of nursing students. (7) “Clinical preceptor” means a registered nurse employee of a cooperating clinical agency acting to facilitate and supervise student learning in a manner specified in a signed written agreement between the cooperating clinical agency and the educational institution. (8) “Clinical preceptorship” means an organized system of clinical experience that allows a nursing student to be paired with a clinical preceptor for the purpose of attaining specific learning objectives. (9) “Conditional approval” means a limited-time status that: (a) Is imposed by the Board if the Board finds evidence that the program has failed to meet or maintain the regulations or requirements, or both, set by the Board; and (b) Allows the program to continue to operate subject to the program conforming to the Board’s requirements and recommendations within a time period set by the Board. (10) “Controlling institution” means an organization that offers a nursing education program. (11) “Cooperating clinical agency” means an agency that provides the facilities and clinical resources for clinical learning experiences in nursing, with the nurse faculty or the clinical nurse faculty of the program responsible for the planning, implementation, and evaluation of these experiences. (12) “Curriculum changes” means changes in course offerings that will alter the curriculum, philosophy, objectives, outcomes, competencies, or conceptual framework of the program. (13) “Full time nurse faculty equivalent” means nursing faculty who are designated as full time employees by their institution. (14) “Generic student” means one who enters at the beginning of the nursing education program and plans to complete the entire curriculum. (15) “Initial approval” means the approval period from the first admission of nursing students to the program through the first full implementation of the curriculum and graduation. (16) “Informatics” means the use of technology in nursing practice. (17) “Licensed practical nurse” means an individual who: (a) Is licensed by the Board to practice licensed practical nursing; or (b) Has a multistate licensure privilege to practice licensed practical nursing. (18) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (19) “MHEC” means Maryland Higher Education Commission. (20) “Nurse faculty” means an individual with a graduate degree in nursing who is employed to teach full-time or part-time in a nursing education program. (21) Program. (a) “Program” means a registered nursing or licensed practical nursing educational program. (b) “Program” includes any of the following: (i) A college; (ii) A school; (iii) A division; (iv) A department; (v) An academic unit; or (vi) A program. (22) “Regional nursing education accrediting agency” means an accrediting agency that operates in a specific geographic region of the United States and accredits post-secondary institutions and primary and secondary schools. (23) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (24) “Requirement” means a mandatory condition that a program meets: (a) For the program to be approved; and (b) To ensure that graduates of the program are eligible to take the NCLEX-RN® and NCLEX-PN®. (25) “Simulation” means instructional activities and strategies that mimic the reality of a clinical environment and complement other clinical learning experiences. (26) “Transfer student” means a student who is permitted to apply nursing courses completed at another institution to a nursing education program of study. (27) “USDOE” means the United States Department of Education. #### Regulation .02 Approval of Programs Accredited by a Board-Recognized Nursing Accreditation Agency. *COMAR 10.27.03.02* A. The Board shall place on its list of approved programs any nursing education program in Maryland granted accreditation by a BRNAA, provided the program meets all requirements of this chapter. B. A program approved by the Board and accredited by a BRNAA agency shall submit to the Board within 30 days of receipt: (1) Evidence of current accreditation; (2) Accreditation reports; and (3) Any correspondence related to the status of the program's accreditation. C. The Board shall continue to grant approval to programs in Maryland filing evidence of continuing accreditation by the BRNAA, provided those programs continue to meet all requirements of this chapter. D. The Board shall be notified in writing within 10 business days of any change in accreditation status by the nursing program. E. Withdrawal of accreditation, accreditation with warning, or failure to meet the requirements of this chapter or the standard for performance on the licensing examination shall be cause for Board review of the program in accordance with Regulations .16B and C and .17 of this chapter. F. A program on which the Board has taken action under Regulations .16B and C and .17 of this chapter shall be reported to MHEC. G. On a periodic basis, the Board shall compare its regulations to those of the BRNAA and the USDOE to ensure that the Board standards for programs are being met. H. The Board and MHEC shall inform one another in a timely manner of proposed changes to regulations that may affect nursing education programs. #### Regulation .03 Board Approval of Nonaccredited Programs. *COMAR 10.27.03.03* A. A Board-approved nursing education program that is not accredited by a BRNAA shall meet the requirements stated in Regulations .04—.16 of this chapter. B. In institutions having both a licensed practical nursing education program and a registered nursing education program and when only one of the programs is accredited by a BRNAA: (1) Except as otherwise provided in Regulation .18 of this chapter, the Board and the BRNAA shall conduct concurrent visits; and (2) The program shall submit an addendum to the accredited program's self-study describing the unique components of the nonaccredited program. C. A program on which the Board has taken action shall be reported to MHEC. #### Regulation .04 Philosophy and Objectives, Outcomes, or Competencies. *COMAR 10.27.03.04* A. The philosophy and program objectives, outcomes, or competencies shall be: (1) Developed by the nursing faculty and represent a consensus of that faculty; (2) Consistent with the characteristics of the specific type of nursing education program; (3) Communicated to those responsible for and participating in the program; and (4) Periodically evaluated. B. The philosophy of the program shall: (1) Be consistent with that of the controlling institution and governing body; (2) Articulate beliefs about individuals and their health, environment, nursing, adult education, and learning; and (3) Serve as a foundation for developing, implementing, and evaluating the educational program. C. The program objectives, outcomes, or competencies shall: (1) Evolve from the philosophy of the program; (2) Be clearly stated, measurable, and attainable; (3) Serve as a foundation for planning, implementing, and evaluating the program; and (4) Identify the expected competencies of the graduate. #### Regulation .05 Administration and Organization. *COMAR 10.27.03.05* A. The controlling institution shall: (1) Be accredited by the appropriate national or regional accrediting agency; and (2) Have a statement of equal educational opportunity. B. The organizational chart shall: (1) Demonstrate the relationship of the nursing program to the controlling institution; (2) Indicate lines of responsibility and authority; and (3) Indicate channels of communication. C. The program shall have comparable status with other academic units within the controlling institution. D. The controlling institution shall provide the financial support and resources needed to operate a program which: (1) Meets the requirements of the Board; and (2) Fosters achievement of program goals. E. The financial resources shall support: (1) Adequate educational facilities and equipment; and (2) Qualified administrative, clerical, and instructional personnel. F. The program shall be administered by a registered nurse who meets the qualifications stated in Regulation .07 of this chapter. G. When the nursing program administrator changes, the administrative officer of the controlling institution shall submit written notification to the Board of the change indicating that the new program administrator meets the Board’s requirements. #### Regulation .06 Records and Reports. *COMAR 10.27.03.06* A. Accurate and appropriate records shall be maintained that include, but are not limited to: (1) Current records of students; (2) Transcripts of graduates; (3) Faculty records; (4) Administrative records, which include: (a) Minutes of faculty meetings; (b) Annual reports of the program; and (c) School bulletins; (5) The current curriculum, including: (a) Philosophy; (b) Objectives or outcomes; and (c) Course outlines; (6) Agreements with cooperating agencies; and (7) A master plan of evaluation. B. Records shall be safely stored to prevent loss, destruction, or unauthorized use. C. The nursing program administrator shall submit an annual report to the Board on forms provided by the Board. #### Regulation .07 Nursing Program Administrator. *COMAR 10.27.03.07* A. Qualifications. (1) Qualifications of the nursing program administrator include: (a) Current licensure as a registered nurse in Maryland or possession of a multistate licensure privilege to practice registered nursing; (b) A graduate degree in nursing; and (c) Academic preparation or experience in administration. (2) A doctorate in nursing or a related field is recommended for the nursing program administrator. B. Responsibilities. The nursing program administrator, with the participation of the faculty, is responsible for: (1) Recommendations for faculty appointment and review; (2) The educational program or programs; (3) Preparing and administering the budget; (4) Formulating and implementing policies pertinent to the program, which include but are not limited to: (a) Admission and progression; (b) Advanced standing; (c) Transfer and articulation; (d) Withdrawal; (e) Reinstatement; (f) Evaluation; (g) Graduation requirements; and (h) Competency in oral and written communication of the English language; (5) Determining the student/teacher ratio based on the objectives of the course, method of instruction used, and the requirements of the faculty; (6) Determining the number of faculty, including clinical faculty, needed based on the: (a) Number and academic level of enrolled students; (b) Curriculum; (c) Activities and responsibilities required of the faculty; and (d) Number and geographic locations of the clinical facilities; (7) Developing, maintaining, complying with, and periodically reviewing written agreements with cooperating agencies; (8) Implementing a faculty orientation and development program; (9) Implementing the entire program in accordance with Board regulations; (10) Assuring that all publications pertaining to the nursing program are clear, accurate, and current; (11) Developing and implementing a written plan that provides that all students participating in clinical practice settings are physically and mentally competent at all times to provide safe client care; and (12) Developing appropriate clinical learning experiences that reflect an understanding of the program's philosophy, objectives, outcomes or competencies, and curriculum. #### Regulation .08 Nurse Faculty and Clinical Nurse Faculty. *COMAR 10.27.03.08* A. Qualifications of Nurse Faculty. (1) Nurse faculty shall: (a) Be currently licensed as a registered nurse in Maryland or have a multistate licensure privilege to practice registered nursing; (b) Be academically and professionally qualified; (c) Maintain expertise appropriate to their teaching responsibilities; and (d) Have a minimum of 2 years of clinical experience as a registered nurse. (2) Except as provided under §B of this regulation, nurse faculty shall have a graduate degree in nursing. (3) Non-nurse faculty, or nurses not meeting the requirements for nurse faculty, may teach selected portions of the nursing curriculum that relate to their areas of expertise. B. Waiver of Graduate Degree in Nursing Requirement for Nursing Faculty. (1) A program experiencing a faculty shortage may petition the Board for a waiver of the graduate degree in nursing required by §A(2) of this regulation. (2) The petition for a waiver of the graduate degree in nursing shall include documentation that the institution has attempted to hire nurse faculty with graduate degrees and a summary of those efforts. (3) The petition in §B(1) of this regulation shall include documentation verifying that the nurse faculty applicant for whom the waiver is requested has: (a) A baccalaureate degree in nursing and a graduate degree in another field; or (b) A baccalaureate degree in nursing and: (i) Is enrolled as a student in an approved graduate study program in nursing; and (ii) Will complete the graduate study program in nursing within 36 months. (4) If the graduate degree in nursing is waived by the Board: (a) The nurse faculty member for whom a waiver has been granted shall complete a minimum of 9 graduate credits in nursing within 24 months of the issuance of the waiver; and (b) The program shall submit documentation to the Board of completion of the required credits by the nurse faculty member within 24 months of the date when the waiver was granted. (5) If the nurse faculty member fails to complete the 9 graduate credits required in nursing within 24 months of the granting of the waiver, the Board may withdraw the waiver. (6) If the waiver has been withdrawn, the program shall require that the nurse faculty member cease functioning as nurse faculty. If the program fails to do so, the Board may take action under Regulation .17 of this chapter. (7) Once the nurse faculty member for whom the waiver was granted has met the 9 graduate credit waiver requirements, that nurse faculty member is considered to have met the educational requirements of §A(2) of this regulation. (8) The Board shall grant a waiver for a nurse faculty member: (a) With experience in teaching; and (b) Who is within a semester of graduation with a graduate degree in nursing. C. Qualifications of Clinical Nurse Faculty. (1) A clinical nurse faculty member shall: (a) Be currently licensed as a registered nurse in Maryland or have a multistate licensure privilege to practice registered nursing; (b) Have a degree in nursing at or above the baccalaureate level; (c) Have a minimum of 2 years of clinical experience as a registered nurse; and (d) Have the clinical experience necessary to function effectively and safely in the clinical nurse faculty's area of responsibility. (2) A program may not, in any academic year, fill more than 25 percent of the program’s full-time nurse faculty equivalent positions with clinical nurse faculty whose highest nursing degree is at the baccalaureate level. D. Responsibilities of Nurse Faculty and Clinical Nurse Faculty. (1) Responsibilities of the nurse faculty include participation in the planning, implementation, evaluation, and revision of the educational program. (2) Nurse faculty shall: (a) Develop and implement standards for admission, progression, and graduation of students; (b) Participate in academic advisement and guidance of students; (c) Evaluate student performance; (d) Maintain clinical skills in the nurse faculty’s area of responsibility; (e) Develop and implement a plan to assure that all instructional materials are accessible, current, and relevant to the curriculum; (f) Participate in the recruitment, selection, and promotion of nurse faculty and the recruitment and selection of clinical nurse faculty; (g) Participate in peer evaluation of nurse faculty and clinical nurse faculty performance; and (h) Elicit student evaluation of teaching effectiveness. (3) Clinical nurse faculty shall: (a) Provide clinical instruction and supervision of students; and (b) Evaluate student performance in clinical learning experiences. #### Regulation .09 Faculty Policies. *COMAR 10.27.03.09* A. There shall be written personnel policies for nurse faculty and clinical nurse faculty that conform to accepted educational standards. B. Policies concerning the teaching load for faculty and the nursing program administrator shall be in writing. Sufficient time shall be provided for faculty to accomplish those activities related to the teaching-learning process. If the program administrator is required to teach, the program administrator shall carry only a minimum teaching load. #### Regulation .10 Faculty Organization. *COMAR 10.27.03.10* A. The faculty shall be organized with written policies and procedures to guide its activities. B. The faculty shall meet regularly and function in such a manner that all members participate in planning, implementing, and evaluating the nursing program. C. Committees necessary to carry out the functions of the program shall be established with the duties and membership of each committee clearly defined. D. As appropriate, students shall participate on faculty committees. E. Minutes of faculty organization and committee meetings shall: (1) Document actions and decisions of the faculty; and (2) Be available for reference. #### Regulation .11 Faculty Development and Evaluation. *COMAR 10.27.03.11* A. There shall be a formal plan for orientation of new nurse faculty and clinical nurse faculty. B. A program of faculty development shall be offered to encourage and assist nurse faculty members and clinical nurse faculty in their professional growth and development. C. A variety of means shall be used to evaluate nurse faculty and clinical nurse faculty’s effectiveness of teaching within the classroom and clinical setting. #### Regulation .12 Resources, Facilities, and Services. *COMAR 10.27.03.12* A. Physical Facilities. The physical facilities shall be adequate to meet the needs of the nursing program and include the following: (1) Office for the administrator, faculty members, and staff; (2) Adequate space for privacy of faculty-student conferences; (3) Classroom, laboratories, simulation laboratories, and conference rooms; (4) Space for equipment and instructional materials; and (5) Space for noninstructional activities of nursing faculty and students. B. Learning resources shall be developed with faculty input and shall be: (1) Accessible to faculty and students; (2) Comprehensive; and (3) Current. C. Educational support services that facilitate students' abilities to achieve the program's objectives, outcomes, or competencies shall be available. D. Cooperating Clinical Agencies. (1) The appropriate authorities shall approve cooperating clinical agencies and all facilities used for clinical learning experiences. (2) Facilities with conditional or provisional approval status may not be used for student learning experiences. (3) Cooperating clinical agencies shall meet the following requirements: (a) Accreditation or approval by the appropriate authority; (b) A sufficient number and variety of clients to provide learning experiences for all students to achieve the stated objectives, outcomes, or competencies; (c) A sufficient number of registered nurses and other nursing personnel to ensure safe and continuous care of clients; and (d) Conformance with accepted standards of nursing care and practice. E. Written Agreements. (1) Written agreements between the program and the cooperating clinical agencies shall specify the responsibility of the program to the cooperating clinical agency and the responsibility of the cooperating clinical agency to the program. (2) Written agreements shall: (a) Be developed jointly with the cooperating clinical agency; (b) Be reviewed periodically; and (c) Include provision for adequate notice of termination. #### Regulation .13 Curriculum. *COMAR 10.27.03.13* A. The curriculum shall be: (1) Planned, implemented, and evaluated by the faculty; (2) Based on the philosophy and program objectives, outcomes, or competencies; (3) Organized logically and sequenced appropriately; and (4) Based on sound educational principles. B. The curriculum plan shall: (1) Serve as the foundation for curriculum development; (2) Define and organize philosophical beliefs, values, and concepts; (3) Operationalize the program objectives or outcomes; (4) Structure concepts and theories to enhance the teaching-learning process; and (5) Provide a model for progressive learning. C. The curriculum objectives, outcomes, or competencies shall: (1) Flow from the curriculum plan; (2) Measure the intended objectives, outcomes, or competencies for program graduates; and (3) Serve as a foundation for: (a) Sequencing of the program; (b) Course objectives; (c) Sequential arrangement of courses; and (d) Distribution of class and clinical hours. D. The curriculum of all programs shall: (1) Be appropriate to the level of the graduate's intended scope of practice; (2) Provide didactic and clinical learning experiences that are diverse and consistent with program objectives, outcomes, or competencies; and (3) Include: (a) Content in the arts and humanities, social and behavioral sciences, and biological and physical sciences; (b) The nursing process; (c) Didactic and clinical instruction which includes, but is not limited to, the following areas: (i) Nursing care of families and clients throughout the life span in a variety of care settings requiring nursing measures appropriate for either the maintenance or restoration of mental and physical health; (ii) Preventive, rehabilitative, and curative aspects of health care; and (iii) Biophysical, psychosocial, cultural, and spiritual components of health and illness; (d) Professional issues content including, but not limited to: (i) The historical development of nursing; (ii) Current issues and trends in nursing; and (iii) Ethical, legal, and professional aspects of nursing; (e) Multidisciplinary communication; (f) Evidence based practice; (g) Patient centered care; (h) Quality improvement; and (i) Informatics. E. The curriculum of baccalaureate degree programs in nursing shall also include: (1) Didactic and clinical experiences in community health nursing; (2) Study of nursing research and its application to nursing; and (3) Study and practice of leadership and management. F. Course objectives, outcomes, or competencies shall serve as: (1) Selection criteria for the location and type of clinical learning experiences; and (2) A basis for evaluation of student performance. G. Changes in course offerings that will alter the curriculum, philosophy, objectives, outcomes, competencies, or conceptual framework of the program shall: (1) Be reported to the Board in the annual report; and (2) Include the following information: (a) The rationale for changes; and (b) The methods of evaluation to be used to determine the effect of the change. H. Students shall be provided didactic instruction either before or concurrent with the related clinical learning experiences. I. Clinical learning experiences shall be sufficient in quantity and quality to provide opportunities for students to achieve the stated objectives, outcomes, or competencies. J. Students shall have sufficient opportunities to develop the knowledge, skills, and abilities essential for a safe and effective nursing practice. K. Evaluation methods and tools used for measuring students’ knowledge, skills, and abilities shall be developed and implemented in order to ensure satisfactory progression of students. L. There shall be a rationale for the ratio of classroom to clinical hours for each clinical nursing course. M. Clinical Preceptorships. (1) When clinical preceptors are used, the following conditions shall be met: (a) Written agreements between the cooperating agency and the nursing program shall delineate the functions and responsibilities of the parties involved; (b) There shall be written criteria for selecting clinical preceptors; (c) The clinical preceptor shall have the following minimum qualifications: (i) Current licensure as a registered nurse, (ii) 2 years of experience as a registered nurse and clinical expertise in the area of nursing required for the experience; and (iii) A philosophy of health care congruent with that of the nursing program; (d) Written clinical objectives, outcomes, or competencies shall be specified and shared with the clinical preceptor before the preceptorship experience begins; and (2) The designated faculty member shall: (a) Be responsible for a student's learning experiences, and (b) Meet regularly with the clinical preceptor and the student for the purpose of monitoring and evaluating learning experiences. (3) A bachelor’s degree in nursing is recommended. (4) Nothing in this section shall be construed to prohibit any cooperating clinical agency’s registered nurses from assisting with clinical activities selected by the program’s nurse faculty or clinical nurse faculty. (5) The program’s nurse faculty or clinical nurse faculty may not be required to be in the cooperating clinical agency’s facilities but shall be immediately available by telephone. #### Regulation .14 Students. *COMAR 10.27.03.14* A. The following shall be available to students: (1) A written statement of students' rights and responsibilities; (2) The opportunity to participate in program development and evaluation; (3) A written grievance mechanism; and (4) Guidance and advisement services. B. Students shall have: (1) Membership on selected faculty committees, as appropriate; and (2) The opportunity to participate in an organization of self-governance. C. Exercise of the right and responsibility to discuss, inquire, and express opinion is encouraged. D. Each program shall have clearly defined written policies for the following: (1) Admission of: (a) Generic students; (b) Transfer students; and (c) Articulation; (2) Oral and written English proficiency in reference to Health Occupations Article, §8-302(e), Annotated Code of Maryland, and COMAR 10.27.01.05; (3) Withdrawals; (4) Readmissions; (5) Progression; (6) Counseling and guidance; (7) Representation on faculty governance; (8) Graduation; (9) Refund policies governing all fees and tuition paid by students; and (10) Ethical practices for the performance of activities, including recruitment, admission, and advertising. E. Each program shall have a written policy providing information to any student who may be subject to licensure denial under Health Occupations Article, §§-308(c) and 8-316(a), Annotated Code of Maryland, and amendments applying to that citation. The information shall be provided before admission to the nursing education program. #### Regulation .15 Program Evaluation. *COMAR 10.27.03.15* A. The faculty shall develop and implement a Board-approved evaluation plan for evaluating the total nursing education program not less than: (1) Every 10 years for programs that are accredited by a BRNAA; and (2) 5 years for programs without BRNAA accreditation. B. The evaluation plan shall include: (1) All components of the program; (2) Evaluation time intervals; (3) Student, graduate, faculty, cooperating clinical agencies, and administration participation; (4) Instruments or methods used; and (5) Evidence that prior recommendations from the Board have been acted upon. C. The evaluation process shall provide evidence that the program is meeting its objectives or outcomes as well as the changing needs of nursing and society. D. The outcome of evaluation includes: (1) Recommendations for necessary program revisions; and (2) Direction for future action. #### Regulation .16 Annual Review. *COMAR 10.27.03.16* A. Annually, a program shall submit the following to the Board: (1) An annual report on the form that the Board requires; (2) A program catalog; (3) Any annual reports to the BRNAA; (4) Any correspondence related to the status of the program's accreditation; (5) A summary of practices followed in safeguarding the health and well-being of students; (6) An audited fiscal report covering the previous 2 years, including a statement of income and expenditures; and (7) Accurate and complete data including, but not limited to, number of enrollments, admissions, graduates, and faculty. B. Annually, the Board shall: (1) Review each program’s annual report, supporting documentation, and the licensure examination performance of first-time candidates from each program; (2) Notify each program achieving less than 90 percent of the national success rate; and (3) If necessary, conduct a survey or site visit, issue recommendations, place a program on conditional approval, or issue a formal notice of violation and withdraw approval in accordance with Regulation .17 of this chapter. C. Approval may be reduced to conditional status for the following reasons: (1) Noncompliance with this chapter; (2) Failure to hire faculty who meet the qualifications as stated in Regulation .08 of this chapter; (3) Noncompliance with the school’s stated philosophy, program design, objectives, or policies; (4) Failure to submit records and reports to the Board in a timely manner; (5) Failure to implement the approved curriculum; (6) In accordance with §D of this regulation, failure to maintain the required passing rate on the licensing examination by first-time candidates; (7) Failure to annually document that all faculty have current licenses; and (8) Other activities or situations, as determined by the Board, that indicate a program is in jeopardy of violating statutory and regulatory requirements and standards. D. Unacceptable Performance on Licensure Examination. (1) The Board shall issue a warning to a program when the pass rate of first-time candidates does not comply with §B(2) of this regulation. (2) For the first year a program does not meet the requirements of §B(2) of this regulation and following the warning in §D(1) of this regulation, the program shall, within 30 calendar days, provide to the Board: (a) A report that identifies the factors believed to have contributed to the unacceptable performance; and (b) An action plan to be approved by the Board. (3) Second Successive Year Not in Compliance. (a) For the second successive year that a program is not in compliance with §B(2) of this regulation, the program shall be placed on conditional approval and shall: (i) Provide the Board with a report analyzing all aspects of the educational program and identifying areas that may be contributing to the unacceptable performance; and (ii) Obtain the services of a Board-approved outside consultant with expertise in nursing education congruent with program needs. (b) The Board’s professional staff shall conduct a survey visit to the school and provide a report to the Board. (4) If compliance with the minimum licensure examination performance standard for first-time candidates is not made by the program within 1 examination year from the date of conditional approval, approval may be withdrawn. #### Regulation .17 Removal from Approved List. *COMAR 10.27.03.17* A. Pursuant to Health Occupations Article, §8-404, Annotated Code of Maryland, at least 30 days before issuing a formal notice of violation of regulations to a program, the Board shall notify the chief administrator of the controlling institution and the chief administrator of the nursing education program that the Board is considering issuing a formal notice of violation. B. During the 30-day period, the Board shall provide the chief administrator of the controlling institution and the nursing education program with an opportunity to meet with representatives of the Board to discuss the Board’s proposed action against the program. C. The program shall notify the Board within the 30-day period if it is interested in meeting with the Board. If the program requests a meeting, the Board shall set up the meeting. D. At the meeting, the program shall submit to the Board a plan with a proposed time frame for correcting the violations. E. The Board shall: (1) Evaluate the plan; (2) Approve or modify the plan; and (3) Have discretion to make changes to the time frames for correcting violations or other components of the plan. F. The program shall correct the violations within the time frames approved by the Board. G. Approval may be withdrawn for the following reasons: (1) Noncompliance with any of the regulations in this chapter; (2) Failure to hire faculty who meet the qualifications as stated in Regulation .08 of this chapter; (3) Noncompliance with the school's stated philosophy, program design, objectives, or policies; (4) Failure to submit records and reports to the Board in a timely manner; (5) Failure to implement the approved curriculum; (6) Failure to comply with the Board’s requirements within the specified time frames; (7) Failure to maintain the required passing rate on the licensing examination by first-time writers; (8) Failure to annually document that all faculty have current licenses; and (9) Other activities or situations, as determined by the Board, that indicate a program is not meeting statutory and regulatory requirements and standards. H. Withdrawal of Approval. If the program does not correct the violations within the approved time frames, the Board shall begin proceedings to remove the program from its list of institutions that offer approved nursing education programs in Maryland pursuant to Health Occupations Article, §§8-316—8-318, and 8-404, Annotated Code of Maryland. #### Regulation .18 New Programs and Continuing Approval Requirements. *COMAR 10.27.03.18* A. New Program Requirements. (1) An institution wishing to establish a nursing program shall submit to the Board: (a) A letter of intent; (b) Proof that the institution is accredited by the appropriate national or regional accrediting agency; (c) A copy of the prospectus and program proposal submitted to MHEC; (d) An addendum that describes in detail the: (i) Type and length of nursing program; (ii) Curriculum plan; (iii) Program objectives, outcomes, or competencies; and (iv) Description of available clinical resources; (e) Evidence that the proposed nursing program is based upon sound educational principles; and (f) Materials validating that the educational institution is prepared to meet the requirements specified in this chapter. (2) A nursing program providing on-site didactic or clinical instruction in Maryland shall comply with this chapter and receive Board approval of the on-site program before the commencement of instruction. (3) Both MHEC and the Board shall collaborate on program review. (4) Following review of the materials submitted, the Board shall notify the institution as to whether further clarifications or revisions are necessary. B. New Program Review. (1) The proposed nursing education program shall be reviewed at a regularly scheduled Board meeting. (2) The Board may: (a) Deny further consideration of the proposal; (b) Defer action on the proposal; or (c) Authorize a site visit by the Board’s professional staff and, following a report of the site visit by the Board’s professional staff, grant initial approval, defer action, or deny the request. (3) If deferred or denied, the institution shall be notified in writing of the reasons for the action. C. Initial Approval. Initial approval: (1) Is required before the admission of students; (2) Requires concurrence of the Maryland Higher Education Commission; and (3) Extends until the school or program has graduated its first class. D. Approval. (1) Following graduation of the first class, the Board shall evaluate the program for approval, considering the: (a) Report of a survey of the program by the Board’s professional staff, scheduled before graduation of the first class; (b) Results of the performance of the graduates on the National Council Licensure Examination; and (c) Program’s demonstrated continued ability to provide an educational program that meets the standards set by the Board. (2) Upon review of the survey report, the results of graduate performance on the National Council Licensure Examination, and an assessment of the program’s continued ability to meet the standards set forth in this chapter, the Board may: (a) Grant approval; (b) Place the program on conditional approval; or (c) Withdraw initial approval in accordance with Regulation .17 of this chapter. (3) Approval, if granted, shall be valid for not more than: (a) 10 years for a program accredited by a BRNAA; and (b) 5 years for a program without BRNAA accreditation. E. Reapproval Requirements. (1) The Board shall evaluate a program for reapproval: (a) Every 5 years if the program is without BRNAA accreditation; and (b) Not more than 10 years after approval is granted if the program has BRNAA accreditation. (2) Evaluation of continuing compliance shall include the submission of a self-study report by the program and a survey visit by the Board’s professional staff. The self-study report shall be submitted to the Board no less than one month prior to the survey visit. (3) If the program is accredited by a BRNAA, the reapproval survey visit may be made in coordination with a BRNAA visit. (4) Unscheduled survey or site visits may be conducted at the discretion of the Board. (5) A program that is accredited by a BRNAA and is subsequently placed on warning or whose accreditation by the BRNAA is withdrawn shall be scheduled immediately for a survey visit. (6) During each survey or site visit, the nurse administrator of the program shall make the following information available: (a) Data about the program, including the following: (i) The number of students; (ii) The legal body responsible for policy and support of the program; (iii) The organizational chart; and (iv) An audited fiscal report covering the previous 2 years, including a statement of income and expenditures; (b) The nurse administrator’s job description; (c) For each faculty member and clinical preceptor, the following: (i) Job descriptions; (ii) Selection policies; (iii) Orientation plan; (iv) Faculty organization by-laws; (v) Number of full-time and part-time faculty and non-nursing faculty with academic credentials and assignments; and (vi) Faculty-student clinical ratio; (d) Degree plan; (e) A copy of the current curriculum and course catalog with the date of last revision; (f) The testing process with test analysis and the written test procedure; (g) A description of education facilities, including classrooms, offices, libraries, and computers; (h) A list of clinical facilities and cooperating clinical agencies; (i) The number of students by classes; and (j) The policies for students as listed in Regulation .14D of this chapter. (7) During each survey or site visit, the nurse administrator shall make available the following: (a) The program’s administrators, faculty, support services personnel, and students; (b) Staff members of selected cooperating clinical agencies; (c) Faculty minutes for at least the previous 3 years; (d) Faculty and student handbooks; (e) Student records; (f) Policies and procedures; (g) Curriculum materials; (h) Cooperating clinical agency contractual agreements; (i) Program evaluation plan and evidence of program effectiveness; and (j) The program’s current catalog. (8) Upon review of the survey report and the results of graduate performance on the National Council Licensure Exam, and an assessment of the program’s continued ability to meet the standards set forth in this chapter, the Board may: (a) Grant reapproval; (b) Place the program on conditional approval; or (c) Withdraw approval in accordance with Regulation .17 of this chapter. (9) Reapproval, if granted, shall be valid for not more than: (a) 10 years for a program accredited by a BRNAA; and (b) 5 years for a program without BRNAA accreditation. #### Regulation .19 Closure of Programs. *COMAR 10.27.03.19* A. Upon request, the Board shall provide consultation concerning closing of a program. B. Upon the decision by a program to close, and at least 90 days before closing, the nurse administrator shall notify the Board of its intent, giving the following information: (1) Date and reason for closing; (2) Plans for phasing out the program; (3) Disposition of the records of students, graduates, and faculty; and (4) Title of the position of the individual to be responsible for the records and the name of the agency in which the records will be located. ### Chapter 04 — Methadone Dispensing **Authority:** Health Occupations Article, §§8-205(a)(1) and 8-511, Annotated Code of Maryland **Administrative History:** Effective date: February 9, 2009 (36:3 Md. R. 209) #### Regulation .01 Dispensing Methadone. *COMAR 10.27.04.01* A. A registered nurse or licensed practical nurse working in a methadone clinic licensed by the Maryland Department of Health may dispense methadone in accordance with: (1) The patient's standing medication order; (2) The methadone clinic's policies and procedures for dispensing methadone; and (3) State and federal laws and regulations for labeling. B. A registered nurse or licensed practical nurse working in a methadone clinic licensed by the Maryland Department of Health shall dispense methadone: (1) In tamper evident containers; (2) In child resistant containers; and (3) With any required patient information documents. C. A registered nurse or licensed practical nurse working in a methadone clinic licensed by the Maryland Department of Health shall maintain records of methadone dispensed in accordance with the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. D. A registered nurse or licensed practical nurse may not delegate the dispensing of methadone. ### Chapter 05 — Practice of Nurse Midwifery **Authority:** Health Occupations Article, §§8-101, 8-205, and 8-601—8-603, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective March 14, 1983 (10:11 Md. R. 970); emergency status expired July 13, 1983; adopted permanently effective October 10, 1983 (10:20 Md. R. 1787) **Administrative History:** Regulation .01 amended effective September 2, 1991 (18:17 Md. R. 1919); April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140) **Administrative History:** Regulation .01B amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .02 amended effective April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140) **Administrative History:** Regulation .02B amended effective September 2, 1991 (18:17 Md. R. 1919) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .03 repealed effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .04 repealed effective April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Regulation .05 amended effective February 15, 1993 (20:3 Md. R. 259); April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140) **Administrative History:** Regulation .06 amended effective April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Regulation .06C amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .07 amended effective April 10, 1995 (22:7 Md. R. 536); March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .07B amended effective February 15, 1993 (20:3 Md. R. 259) **Administrative History:** Regulation .08 amended effective February 15, 1993 (20:3 Md. R. 259); April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Regulation .09 amended effective February 15, 1993 (20:3 Md. R. 259); April 10, 1995 (22:7 Md. R. 536); June 26, 2000 (27:12 Md. R. 1140) **Administrative History:** Regulation .10 amended effective April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Regulation .11 adopted effective September 2, 1991 (18:17 Md. R. 1919) **Administrative History:** Regulation .11 amended effective April 10, 1995 (22:7 Md. R. 536); March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Chapter revised as an emergency provision effective January 1, 2010 (37:6 Md. R. 474); revised permanently effective June 28, 2010 (37:13 Md. R. 852) **Administrative History:** Chapter revised effective September 29, 2014 (41:19 Md. R. 1079) **Administrative History:** Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667); October 13, 2025 (Md. R. 1001) **Administrative History:** Regulation .02 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .06B amended effective October 13, 2025 (Md. R. 1001) **Administrative History:** Regulation .06D adopted effective October 13, 2025 (Md. R. 1001) **Administrative History:** Regulation .07 repealed effective February 22, 2026 (52:17 Md. R. 875) **Administrative History:** Regulation .08 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .09 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .10 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .11 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Annotation: COMAR 10.11 Midwifery was replaced by COMAR 10.27.05 Practice of Nurse Midwifery **Administrative History:** Annotation: COMAR 10.11 Midwifery adopted effective February 1, 1957; repealed effective July 12, 1987 (14:14 Md. R. 1572) #### Regulation .01 Definitions. *COMAR 10.27.05.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ACME” means the Accreditation Commission for Midwifery Education. (2) “ACNM” means the American College of Nurse Midwives. (3) “Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as: (a) A certified nurse midwife (CNM); (b) A certified registered nurse anesthetist (CRNA); (c) A certified nurse practitioner (CRNP); or (d) A clinical nurse specialist (CNS). (4) “AMCB” means the American Midwifery Certification Board. (5) “Board” means the Board of Nursing. (6) “Certification” means the permission to practice nurse midwifery granted by the Board to a registered nurse who has: (a) Met all the specified requirements of a national certifying body recognized by the Board; and (b) Complied with the requirements of this chapter. (7) “Certified nurse midwife” means an advanced practice registered nurse who is certified by the Board to practice nurse midwifery in this State. (8) “Clinical practice guidelines” standards for practice of midwifery using current guidelines established by ACNM in Standards for the Practice of Midwifery. (9) “Delegated medical functions” means those functions that come within the definition of “practice medicine” in the Health Occupations Article, §14-101, Annotated Code of Maryland, that have been delegated to a certified nurse midwife to perform. (10) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (11) “Newborn” means an infant in the first 28 days after birth. (12) “Nurse midwifery” means the health care management of newborns and clients throughout their reproductive life cycle. (13) “Physician” means an individual licensed to practice medicine in this State. (14) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. #### Regulation .02 Certification. *COMAR 10.27.05.02* A. An applicant for certification as a nurse midwife shall: (1) Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered nursing; (2) Have graduated from a Board-approved graduate level program for nurse midwives at the Masters’ level or higher that is accredited by: (a) The National League for Nursing Accreditation Commission (NLNAC); (b) The Commission on Nursing Education (CCNE); (c) ACME; or (d) Any other accrediting body recognized by the Board; (3) Hold a current national certification as a nurse midwife from the AMCB or any other national certifying body recognized by the Board; (4) Submit to the Board a completed application for certification as a nurse midwife; (5) Submit an affidavit that the applicant agrees to comply at all times with the clinical practice guidelines in accordance with Regulation .01B(8) of this chapter when providing clinical midwifery services; (6) Comply with all the requirement set forth in COMAR 10.27.01.04; (7) Demonstrate written and oral competency in the English language; and (8) Pay all fees. B. If the applicant’s nurse midwifery program was completed before July 1, 2014, and was not at a Master’s degree or higher level, but the applicant otherwise qualifies for certification, the applicant shall provide the Board with: (1) Verification of completion of a nurse midwifery program recognized by AMCB; and (2) Current national certification by AMCB or any other national certifying body recognized by the Board. #### Regulation .03 Duties of the Board. *COMAR 10.27.05.03* The Board shall: A. Maintain an up-to-date list of all certified nurse midwives in this State; and B. Include on the nurse midwife's registered nursing license an indication that the licensee is certified as a nurse midwife. #### Regulation .04 Required Documentation. *COMAR 10.27.05.04* A. A certified nurse midwife who provides clinical midwifery services across the reproductive lifespan shall: (1) Maintain a medical record for each client; and (2) In the case of a transfer of care to another provider or a facility, transfer the client’s medical records with the client. B. A certified nurse midwife who provides clinical midwifery services shall have available at all times for examination by the Board, written clinical practice guidelines that cover all aspects of care, practice, and quality assurance, including but not limited to: (1) A plan for emergency consultation; (2) A plan for transfer of care; and (3) If needed, a plan for admission of the client or newborn to a hospital within the client’s geographic area. #### Regulation .05 Practice Before Certification. *COMAR 10.27.05.05* A. A registered nurse who meets the qualifications to sit for the AMCB national certifying examination or any other certifying examination approved by the Board who has taken that examination and is waiting for the results of it may practice as a nurse midwife graduate before certification if the: (1) Practice is under the supervision of a certified nurse midwife who shall be physically available to the nurse midwife graduate; (2) Supervising certified nurse midwife signs a written supervision agreement on the required form to provide the supervision; and (3) Nurse midwife graduate files with the Board a copy of the admission slip to the Board-approved certifying examination and a copy of the signed supervision agreement. B. A nurse midwife graduate who has entered into a supervision agreement under this regulation shall immediately notify the Board and the supervising certified nurse midwife of the results of the Board-approved certifying examination. C. A nurse midwife graduate may not continue to practice under a supervision agreement under this regulation for more than 1 year from the filing of all documents required under §A of this regulation, or after the denial of AMCB or other Board-approved certification, whichever occurs first. #### Regulation .06 Scope of Practice. *COMAR 10.27.05.06* A. A certified nurse midwife who meets the requirements of Regulation .02 of this chapter may perform the following functions: (1) Independent management of clients appropriate to the skill and educational preparation of the certified nurse midwife and the nurse midwife's clinical practice guidelines; (2) Consult or collaborate with a physician or other health care provider as needed; and (3) Refer clients with complications beyond the scope of practice of the certified nurse midwife to a licensed physician. B. A certified nurse midwife shall keep a record of all cases attended and maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. C. A certified nurse midwife has the right and obligation to refuse to perform any delegated medical act, oral or written, if, in the certified nurse midwife’s judgment, it is unsafe or an invalidly prescribed medical act or beyond the competence of the certified nurse midwife, in which case the nurse midwife shall notify the delegating physician at once. D. A certified nurse midwife shall comply with applicable State and federal law. #### Regulation .07 Nurse Midwife Peer Review Advisory Committee. — Repealed. *COMAR 10.27.05.07* #### Regulation .08 Renewal of Certification. *COMAR 10.27.05.08* A. Certification as a nurse midwife expires at the same time as the nurse midwife's registered nursing license unless the certification is renewed. B. Before a nurse midwife’s certification expires, the nurse midwife may renew the certification biennially if the nurse midwife: (1) Is otherwise entitled to be certified; (2) Submits to the Board: (a) Documentation of a current national certification as a nurse midwife from AMCB or another national certifying body recognized by the Board; and (b) A completed renewal application on the form that the Board requires; and (3) Pays all fees. C. Certified nurse midwife renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J — N. D. The certified nurse midwife shall ensure that the Board has a record of the renewed national certification if the national certification expires before the registered nurse license renewal date. E. Certification as a nurse midwife shall be deemed to have lapsed if the Board does not have a record of a current active national certification. F. Practicing on an expired national certification is prohibited and subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland. #### Regulation .09 Compliance. *COMAR 10.27.05.09* The certified nurse midwife shall develop and comply with clinical practice guidelines as defined in Regulation .01B of this chapter. #### Regulation .10 Unlawful Practices. *COMAR 10.27.05.10* Pursuant to Health Occupations Article, Title 8, Subtitle 7, Annotated Code of Maryland, an individual may not: A. Practice nurse midwifery unless certified under these regulations or otherwise permitted by law to engage in those activities; B. Use the title nurse midwife, certified nurse midwife, or any other similar designation unless certified by the AMCB, or other certifying body approved by the Board; or C. Use the title certified nurse midwife unless certified by the Board. #### Regulation .11 Prescribing of Substances by a Certified Nurse Midwife. *COMAR 10.27.05.11* Pursuant to Health Occupations Article, §8-601, Annotated Code of Maryland, a certified nurse midwife may prescribe: A. Substances commonly used in the practice of nurse midwifery; and B. Controlled substances on Schedules II-V under Criminal Law Article, §§5-403 — 5-406, Annotated Code of Maryland, commonly used in the practice of nurse midwifery; and C. Dispense substances prescribed in accordance with §§A and B of this regulation in the course of treating a client at a: (1) Nonprofit medical facility or clinic; (2) Health center operating on the campus of an institution of higher learning; (3) Public health facility; (4) Medical facility under contract with a State or local health department; or (5) Facility funded with public funds. ### Chapter 06 — Practice of Nurse Anesthetist **Authority:** Health Occupations Article, §§8-205(a)(1), (3), (4), and (5), and 8-513; Annotated Code of Maryland **Administrative History:** Effective date: December 1, 1979 (6:21 Md. R. 1709) **Administrative History:** Regulations .01—.09 repealed and new Regulations .01—.08 adopted effective April 3, 2000 (27:6 Md. R. 642) **Administrative History:** Regulation .01B amended effective June 17, 2019 (46:12 Md. R. 544) **Administrative History:** Regulation .02 amended effective November 23, 2006 (33:23 Md. R. 1796); June 17, 2019 (46:12 Md. R. 544) **Administrative History:** Regulation .02B amended effective June 18, 2007 (34:12 Md. R. 1067) **Administrative History:** Regulation .03 amended effective June 17, 2019 (46:12 Md. R. 544) **Administrative History:** Regulation .04B amended effective June 17, 2019 (46:12 Md. R. 544) **Administrative History:** Regulation .04C—E adopted effective June 17, 2019 (46:12 Md. R. 544) **Administrative History:** Regulation .05 amended effective June 17, 2019 (46:12 Md. R. 544) **Administrative History:** Regulation .05A amended effective January 19, 2026 (53:1 Md. R. 20) **Administrative History:** Regulation .05D adopted effective January 19, 2026 (53:1 Md. R. 20) **Administrative History:** Regulation .06A, C amended effective June 17, 2019 (46:12 Md. R. 544); October 13, 2025 (52:20 Md. R. 1002) #### Regulation .01 Definitions. *COMAR 10.27.06.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “A.A.N.A.” means the American Association of Nurse Anesthetists. (2) “Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as: (a) A certified nurse midwife (CNM); (b) A certified registered nurse anesthetist (CRNA); (c) A certified nurse practitioner (CRNP); or (d) A clinical nurse specialist (CNS). (3) “Anesthesiologist” means a Maryland-licensed physician who: (a) Has had special training in the field of anesthesiology; (b) Administers anesthesia on a regular basis; and (c) Devotes a substantial portion of the physician's medical practice to the practice of anesthesiology. (4) “Board” means the Board of Nursing. (5) “Certification” means the permission to practice nurse anesthesia granted by the Board to a registered nurse who has: (a) Met all the specified requirements of a national certifying body recognized by the Board; and (b) Complied with the requirements of this chapter. (6) “Certified registered nurse anesthetist (CRNA)” means an advanced practice registered nurse who is certified by the Board to practice as a nurse anesthetist in this State. (7) “Licensed physician or dentist” means a Maryland-licensed physician or dentist who has knowledge and experience in resuscitation, anesthetic drugs, and their reactions. (8) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (9) “Perioperative assessment and management” means the assessment and management of the patient preoperatively, intraoperatively, and postoperatively. (10) “Practice of nurse anesthesia” means the performance of acts in collaboration with an anesthesiologist, licensed physician, or dentist, which require substantial specialized knowledge, judgment, and skill related to the administration of anesthesia, including: (a) Perioperative assessment and management of patients requiring anesthesia services; (b) Administering anesthetics; (c) Management of fluid in intravenous therapy; and (d) Respiratory care. (11) “Qualified anesthesia provider” means a physician, dentist, or certified registered nurse anesthetist trained and duly authorized under the respective provisions of the Health Occupations Article to administer local, regional, and general anesthesia. (12) “Registered Nurse” means an individual who is licensed by the Board to practice registered nursing or has a multistate licensure privilege to practice registered nursing in this State under the Nurse Licensure Compact. #### Regulation .02 Certification. *COMAR 10.27.06.02* A. An applicant for certification as a CRNA shall: (1) Hold a current Maryland license in good standing or a multistate licensure privilege to practice registered nursing in this State under the Nurse Licensure Compact; (2) Have graduated from an education program in nurse anesthesia approved by the Board; (3) Hold current national certification from the Council on Certification of Nurse Anesthetists or from another national certifying body recognized by the Board; (4) Submit to the Board a completed application for certification as a nurse anesthetist; (5) Comply with all the requirements set forth in COMAR 10.27.01.04; (6) Demonstrate oral and written competency in the English language; and (7) Pay all fees. B. If the applicant’s nurse anesthetist program was completed after January 1, 2008, the applicant for certification as a CRNA shall also provide to the Board documentation that the applicant graduated from a graduate level accredited nurse anesthetist program with a master’s degree or higher. #### Regulation .03 Practice Before Certification. *COMAR 10.27.06.03* A. A registered nurse who has completed a program for preparation of nurse anesthetists and who has applied to take a national certifying examination acceptable to the Board may practice as a nurse anesthetist graduate before certification in the State, on approval of the Board, if the nurse: (1) Has a current license or multistate privilege to practice registered nursing in the State; (2) Submitted in full the application for State certification as a CRNA; (3) Paid all fees established by the Board; (4) Completed a nurse anesthetist program approved by the Board; (5) Practices under the supervision of an anesthesiologist or CRNA and the supervisor is on site and immediately available to the nurse anesthetist graduate; (6) Provides the Board a copy of the admission document to the national certification examination which must be taken not later than 6 months after program completion; and (7) Immediately notifies the Board and the supervising anesthesiologist or CRNA of the results of the certification examination. B. A nurse anesthetist graduate who fails the national certification examination shall immediately cease practice as a nurse anesthetist graduate. #### Regulation .04 Renewal of Certification. *COMAR 10.27.06.04* A. Certification as a nurse anesthetist expires at the same time as the nurse anesthetist's registered nursing license unless the certification is renewed. B. Before a nurse anesthetist’s certification expires, the nurse anesthetist may renew the certification biennially, if the nurse anesthetist: (1) Is otherwise entitled to be certified; (2) Pays all appropriate renewal fees set by the Board; and (3) Submits to the Board: (a) A completed renewal application on the form required by the Board; and (b) Documentation of a current national certification as a nurse anesthetist from the Council on Certification of Nurse Anesthetists or some other national certifying body recognized by the Board. C. Nurse anesthetist renewal applicants who are authorized to practice registered nursing in this State under a multistate privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J—N. D. The nurse anesthetist shall ensure that the Board has a record of the renewed national certification if the national certification expires before the renewal date. E. Practicing on an expired national certification is prohibited and subject to disciplinary action under Health Occupations Article, §8-316, Annotated Code of Maryland. #### Regulation .05 Scope of Practice. *COMAR 10.27.06.05* A. A nurse anesthetist may perform the following functions: (1) Perioperative assessment and management of patients requiring anesthesia services; (2) Administration of anesthetic agents; (3) Management of fluids in intravenous therapy; (4) Respiratory care; and (5) In accordance with §D of this regulation, prescribe, order, and administer drugs, including a drug that is classified as a controlled dangerous substance under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland. B. A nurse anesthetist has the right and obligation to refuse to perform a delegated act if, in the nurse anesthetist’s judgment, the act is: (1) Unsafe; (2) An invalidly prescribed medical act; or (3) Beyond the clinical skills of the nurse anesthetist. C. Section A of this regulation may not be construed to authorize a nurse anesthetist to: (1) Diagnose a medical condition; (2) Provide care that is not consistent with the scope of practice of nurse anesthetists; or (3) Provide care for which the nurse anesthetist does not have proper education and experience. D. A nurse anesthetist may prescribe drugs in accordance with §A of this regulation: (1) Only in an amount that does not exceed a 10-day supply; (2) Only for an individual with whom the nurse anesthetist has, at the time of prescription, established a client or patient record; and (3) Only in connection with the delivery of anesthesia services. #### Regulation .06 Standards of Practice. *COMAR 10.27.06.06* A. A nurse anesthetist shall collaborate with an anesthesiologist, licensed physician, or dentist in the following manner: (1) An anesthesiologist, licensed physician, or dentist shall be physically available to the nurse anesthetist for consultation at all times during the administration of, and recovery from, anesthesia; (2) An anesthesiologist shall be available for consultation to the nurse anesthetist for other aspects of the practice of nurse anesthesia; and (3) If an anesthesiologist is not available, a licensed physician or dentist shall be available to provide this type of consultation. B. The nurse anesthetist shall assure that a qualified anesthesia provider: (1) Performs a thorough and complete preanesthetic assessment; (2) Obtains informed consent for the planned anesthetic intervention from the patient or responsible other; and (3) Formulates a patient-specific plan for anesthesia care. C. The nurse anesthetist as part of the standards of practice shall: (1) Implement and adjust the anesthesia care plan as needed to adapt to the patient's response to the anesthesia; (2) Monitor the patient's physiologic condition for untoward identifiable reactions and initiate appropriate corrective actions as required; (3) Enter prompt, complete, and accurate documentation of pertinent information on the patient's record; (4) Transfer responsibility for care of the patient to other qualified providers in a manner which assures continuity of care and patient safety; (5) Ensure that appropriate safety precautions are taken to minimize the risks of fire, explosion, electrical shock, and equipment malfunction; (6) Maintain appropriate infection control standards; (7) Evaluate anesthesia care to assure its quality; (8) Maintain continual competence in anesthesia practice; (9) Respect and maintain the basic rights of patients; and (10) Maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .07 Unlawful Practices. *COMAR 10.27.06.07* A. Under Health Occupations Article, Title 8, Subtitle 7, Annotated Code of Maryland, a person may not: (1) Practice nurse anesthesia unless certified under this chapter, or otherwise permitted by law to engage in these activities; or (2) Use the title nurse anesthetist, or any other words, letters, or symbols with the intent to represent that the individual is a nurse anesthetist unless certified by the Board. B. A person certified under this chapter is subject to the disciplinary sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland. C. This chapter does not limit or prohibit a registered nurse from performing those functions which constitute the practice of registered nursing as defined by law. #### Regulation .08 CRNA Peer Review/Advisory Committee. *COMAR 10.27.06.08* A. The Board shall appoint at least four CRNAs to act as the Board's advisory committee. B. The Committee shall: (1) Meet at least four times a year; (2) Report at least annually on its overall activities; and (3) Function at the Board's direction and provide the Board with expert advice related to the practice of nurse anesthesia. C. Members of the Committee shall be appointed for a 4-year term and may be reappointed for one additional 4-year term. ### Chapter 07 — Practice of the Nurse Practitioner **Authority:** Family Law Article, §2-301; Health-General Article, §§4-208(a), 4-212, §4-403, 5-601(c)—(e), 5-608(c), 10-616, 10-628, 13-701, and 13-704; Health Occupations Article, §§8-205(a)(1), (2), (4), and (5), and 8-302; Transportation Article, §§13-616(a) and (b), Annotated Code of Maryland; Ch. 342, Acts of 2015; Ch. 468, Acts of 2015 **Administrative History:** Effective date: March 6, 1981 (8:5 Md. R. 473) **Administrative History:** Regulation .01B amended effective August 29, 1994 (21:17 Md. R. 1439) **Administrative History:** Regulation .02 amended effective June 7, 1993 (20:11 Md. R. 913) **Administrative History:** Regulation .03A amended effective June 7, 1993 (20:11 Md. R. 913) **Administrative History:** Regulation .04 amended effective June 7, 1993 (20:11 Md. R. 913) **Administrative History:** Regulation .05 repealed and new Regulation .05 adopted effective June 7, 1993 (20:11 Md. R. 913) **Administrative History:** Regulation .08 adopted effective August 29, 1994 (21:17 Md. R. 1439) **Administrative History:** Chapter revised effective July 11, 2011 (38:14 Md. R. 790) **Administrative History:** Chapter revised effective December 10, 2015 (42:24 Md. R. 1505) **Administrative History:** Regulation .02A amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Chapter revised effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03G adopted effective October 13, 2025 (52:20 Md. R. 1002) **Administrative History:** Regulation .07C amended effective October 13, 2025 (52:20 Md. R. 1002) #### Regulation .01 Definitions. *COMAR 10.27.07.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “AANPNCB” means the American Academy of Nurse Practitioners National Certification Board. (2) “Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as: (a) A certified nurse midwife (CNM); (b) A certified registered nurse anesthetist (CRNA); (c) A certified nurse practitioner (CRNP); or (d) A clinical nurse specialist (CNS). (3) “Board” means the Board of Nursing. (4) “Certification” means permission to practice as a nurse practitioner granted by the Board to a registered nurse who has: (a) Met all the specified requirement of a national certifying body recognized by the Board; and (b) Complied with the requirements of this chapter. (5) “Collaborating” means a cooperative relationship with other health care providers. (6) “Facility” means a health care facility as defined under Health-General Article, §19-114(d), Annotated Code of Maryland. (7) “Mentor” means a certified nurse practitioner or physician, licensed in Maryland, who: (a) Has 3 or more years of clinical practice experience; and (b) Will be available for advice, consultation, and collaboration, as needed, for 18 months beginning on the date an application is received by the Board from an applicant who has never been certified in this or any other State. (8) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (9) “Nurse practitioner” means an advanced practice registered nurse who is certified by the Board to practice as a nurse practitioner in this State. (10) “Personally prepare and dispense” means that a nurse practitioner: (a) Is physically present on the premises where the prescription is filled; and (b) Performs a final check of the prescription before the prescription is provided to the patient. (11) “Physician” means an individual who has an unencumbered license to practice medicine, issued under Health Occupations Article, Title 14, Annotated Code of Maryland. (12) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (13) “Starter dosage” means an amount of a drug sufficient to begin therapy: (a) Of a short duration of 72 hours or less; or (b) Before obtaining a larger quantity of the drug to complete therapy. (14) “Unencumbered license” means a license that is not: (a) Revoked; (b) Suspended; or (c) On probationary status. #### Regulation .02 Certification. *COMAR 10.27.07.02* A. An applicant for certification as a nurse practitioner shall obtain certification from the Board before commencing practice. B. An applicant for certification as a nurse practitioner shall: (1) Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered nursing; (2) Have graduated from a Board-approved accredited graduate level program for nurse practitioners at the Masters’ level or higher that meets the requirements of Regulation .06 of this chapter; (3) Hold a current national certification: (a) For each area of specialization in which certification is sought; and (b) From the AANPNCB or other national certifying body recognized by the Board; (4) Submit to the Board a completed application for certification as a nurse practitioner for each area of specialization in which certification is sought; (5) Comply with all the requirements set forth in COMAR 10.27.01.04; (6) Demonstrate written and oral competency in the English language; (7) If the applicant has not been certified by the Board or any other Board of Nursing, identify a designated mentor for 18 months as defined in Regulation .01 of this chapter; and (8) Pay all fees. C. The Board shall: (1) Maintain an up-to-date list of all nurse practitioners certified in the State; and (2) Include on the nurse practitioner’s registered nursing license an indication that the licensee is certified as a nurse practitioner and designate the nurse practitioner’s area of specialization. D. The Board shall certify a nurse practitioner consistent with the nurse practitioner’s specialty, education, and national certification. #### Regulation .03 Nurse Practitioner — Scope and Standards of Practice. *COMAR 10.27.07.03* A. A nurse practitioner may independently perform the following functions: (1) A comprehensive physical assessment of patients; (2) In accordance with Family Law Article, §2-301, Annotated Code of Maryland, certify to the clerk of the court that a: (a) 16 or 17 year old individual, who wants to get married without parental consent, has been examined and found to be pregnant or has given birth to a child; or (b) 15 year old individual, who has parental consent to be married, has been examined and found to be pregnant or has given birth to a child; (3) In accordance with Transportation Article, §13-704, Annotated Code of Maryland, certify to the Department of Transportation that an individual needs special consideration for certain health reasons; (4) In accordance with Health-General Article, §4-208, Annotated Code of Maryland, complete the date of birth and medical information required on a birth certificate; (5) In accordance with Health-General Article, §4-212, Annotated Code of Maryland, complete a death certificate if: (a) The medical examiner does not take charge of the body; and (b) The deceased was under the care of the nurse practitioner; (6) Establish medical diagnosis for common short-term and chronic stable health problems; (7) In accordance with Health-General Article, §4-212, Annotated Code of Maryland, file a replacement death certificate; (8) In accordance with Health-General Article, §5-601, Annotated Code of Maryland, issue a “do not resuscitate order” on a Maryland Emergency Medical Services form. (9) Order, perform, and interpret laboratory and diagnostic tests; (10) Order and perform diagnostic, therapeutic, and corrective measures; (11) Prescribe drugs; (12) Provide emergency care; (13) Refer patients to appropriate licensed physicians or other health care providers as needed; (14) In accordance with COMAR 20.31.03.01, certify that the utility client has a serious illness or the need for life-support equipment; and (15) In accordance with Health-General Article, §5-602, Annotated Code of Maryland, witness an advance directive. B. A psychiatric nurse practitioner together with a physician is authorized to sign applications: (1) In accordance with Health-General Article, §10-615, Annotated Code of Maryland, to admit a minor to a facility for treatment of a mental disorder; and (2) In accordance with Health-General Article, §10-616, Annotated Code of Maryland, to admit an individual on an involuntary basis to a facility for treatment of a mental disorder. C. A nurse practitioner may practice only in the area of specialization in which certified. D. Nothing in this chapter limits or prohibits a registered nurse from performing those functions which constitute the practice of registered nursing as defined by law. E. A nurse practitioner has a right and obligation to refuse to perform any delegated act, oral or written, if in the nurse practitioner's judgment it is unsafe or an invalidly prescribed medical act. F. An individual certified under this chapter shall be subject to disciplinary sanctions set forth in Health Occupations Article, §8-316, Annotated Code of Maryland. G. A nurse practitioner shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .04 Renewal of Certification. *COMAR 10.27.07.04* A. A certification as a nurse practitioner expires at the same time as the nurse practitioner's registered nursing license. B. Before a nurse practitioner’s certification expires, the nurse practitioner may renew the certification biennially if the nurse practitioner: (1) Is otherwise entitled to be certified; (2) Submits to the Board: (a) Documentation of every current national certification as a nurse practitioner from a national certifying body recognized by the Board that was the basis of the Board’s initial certification under Regulation .02B of this chapter; and (b) A completed renewal application on the form that the Board requires; and (3) Pays all fees. C. Certified nurse practitioner renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J—N. D. The certified nurse practitioner shall ensure that the Board has a record of each renewed national certification if any national certification expires before the registered nurse license renewal date. E. Certification as a nurse practitioner in an area of specialization shall be deemed to have lapsed if the Board does not have a record of the current active national certification in that area of specialization. F. Practicing on an expired national certification is prohibited and subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland. #### Regulation .05 Practice Before Maryland Certification. *COMAR 10.27.07.05* A. A registered nurse who has completed a Board-approved educational program for nurse practitioners and who has applied to take a Board-approved national certifying examination may practice as a nurse practitioner graduate before certification in this State upon approval of the Board if the nurse has: (1) Submitted a completed application for certification as a nurse practitioner in this State in accordance with Regulation .02 of this chapter; (2) Completed a nurse practitioner education program approved by the Board; (3) Presented evidence of submission of an application to take a Board-approved national certification examination; (4) Provided the name of a certified nurse practitioner, who has an active unencumbered Maryland license to practice as a registered nurse or a multistate privilege to practice registered nursing, who will directly supervise the nurse practitioner graduate; and (5) Paid all fees. B. If a certified nurse practitioner is not available in the graduate’s practice setting, as required in §A(4) of this regulation, a physician may provide this direct supervision if the nurse practitioner graduate provides the Board with the name of a certified nurse practitioner, who has an active unencumbered Maryland license to practice registered nursing or a multistate licensure privilege to practice registered nursing, with whom the nurse practitioner graduate has regular consultation. C. A nurse practitioner graduate who fails the Board-required examination shall immediately cease practice as a nurse practitioner graduate. D. An application for Maryland certification shall remain on file for a period of 18 months. During this time, applicants who have failed a national certifying examination may retake the examination and, upon proof of passing, may become eligible for Maryland certification. #### Regulation .06 Education. *COMAR 10.27.07.06* A. An applicant certified by a national certifying body before October 1, 2010, who is certified by the Board and in good standing shall be deemed to meet the education requirements under this regulation. B. An applicant for certification shall be a graduate from a Board-approved nationally accredited education program for nurse practitioners in a school of nursing that: (1) Provides advanced practice instruction at the Masters’ level or higher in a clinical nursing program; (2) Is accredited by a nursing accrediting body recognized by the United States Department of Education, the Council for Higher Education Accreditation or any other national accrediting body recognized by the Board; (3) Follows established educational standards that build upon educational preparation and experience as a registered nurse; (4) Ensures completion of the advanced practice core, nurse practitioner core, and population specific core competencies; (5) Has a didactic and clinical curriculum that, at a minimum, includes advanced courses in: (a) Physiology and pathophysiology; (b) Physical and health assessment; (c) Pharmacology; and (d) Diagnosis and management of health problems and diseases commonly encountered within the respective nurse practitioner’s population focus; (6) Provides didactic courses and supervised clinical experiences of sufficient depth and breadth in the nurse practitioner role and the specific population focus of the program; and (7) Ensures that graduates of the program are eligible for national certification and Maryland certification. C. To be a Board-approved education program the program shall: (1) Be a nationally accredited education program; and (2) Ensure ongoing competence and maintenance of certification by: (a) Providing a mechanism for renewing certification; (b) Having a renewal of certification process that is acceptable to the Board; and (c) Developing a mutually agreeable procedure that ensures communication with the Board. #### Regulation .07 Preparing and Dispensing. *COMAR 10.27.07.07* A. A nurse practitioner may personally prepare and dispense any drug that a nurse practitioner is authorized to prescribe in the course of treating a patient at: (1) A medical facility or clinic that specializes in the treatment of medical cases reimbursable through workers' compensation insurance; (2) A medical facility or clinic that is operated on a nonprofit basis; (3) A health center that operates on a campus of an institution of higher education; (4) A public health facility, a medical facility under contract with a State or local health department, or a facility funded with public funds; or (5) A nonprofit hospital or a nonprofit hospital out-patient facility as authorized under the policies established by the hospital. B. A nurse practitioner who personally prepares and dispenses a drug in the course of treating a patient shall: (1) Comply with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland; (2) Record the dispensing of the prescription drug on the patient's chart; (3) Allow the Division of Drug Control to enter and inspect the nurse practitioner's office at all reasonable hours; (4) Except for starter dosages or samples dispensed without charge, provide the patient with a written prescription; and (5) Stamp all Schedule III, IV, and V prescriptions with the letter “C” in red ink, not less than 1 inch high in the lower right hand corner. C. A nurse practitioner shall: (1) Maintain two separate files, one for Schedule II prescriptions and another file for all other prescriptions; and (2) Maintain all prescription files for 7 years. D. A nurse practitioner may personally prepare and dispense a starter dosage of any drug the nurse practitioner is authorized to prescribe. The nurse practitioner shall: (1) Label the starter dosage in compliance with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland; (2) Provide the starter dose free of charge; and (3) Enter the starter dose dispensed in the patient's medical record. #### Regulation .08 Unlawful Practices. *COMAR 10.27.07.08* Unless authorized to practice as a nurse practitioner under Health Occupations Article, Title 8, Annotated Code of Maryland, an individual may not: A. Represent to the public by title or by description of services, methods, procedures, or otherwise, that the individual is authorized to practice as a nurse practitioner in this State; B. Use as a title or describe the services the individual provides by use of the words “nurse practitioner” or “certified nurse practitioner”; or C. Use the abbreviation “NP”, “CRNP”, “CNP”, or any other words, letters, or symbols with the intent to represent that the individual practices as a nurse practitioner. ### Chapter 08 — Petition for Declaratory Ruling **Authority:** State Government Article, §§10-301 — 10-305, Annotated Code of Maryland **Administrative History:** Effective date: February 22, 1988 (15:4 Md. R. 474) **Administrative History:** Regulation .02 amended effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulation .03 amended effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulation .04 amended effective April 16, 2001 (28:7 Md. R. 690) #### Regulation .01 Definitions. *COMAR 10.27.08.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Nursing. (2) “Person” means an individual, an agency, an association, a corporation, or any other entity. #### Regulation .02 Petition. *COMAR 10.27.08.02* A. An interested person may file with the Board a petition for a declaratory ruling with respect to the manner in which the Board would apply: (1) A statute; (2) A regulation; or (3) An order which the Board enforces to a particular case based on the facts presented in the petition. B. The Board may delegate responsibility for consideration of the petition. C. Petition for Declaratory Ruling. (1) The petition for a declaratory ruling shall be filed in writing. (2) The petition shall contain a statement describing in detail: interest of the petitioner in making: (a) The interest of the petitioner in making the request; (b) The issue involved; (c) A statement of the facts; and (d) A list of relevant documents or statements, or both, to be considered. (3) The Board may require an affidavit from the petitioner that the facts contained in the petition are true to the best of the person's knowledge and belief. D. Granting of Petition. (1) Not later than 60 days from receipt of the petition the Board shall inform the petitioner whether the petition will be considered. (2) If the Board decides not to consider the petition, the Board shall inform the petitioner in writing of the reasons for denial. #### Regulation .03 Consideration and Disposition. *COMAR 10.27.08.03* A. In rendering its ruling the Board or its designee: (1) Shall consider all materials submitted with the petition; (2) May consider any document, data, or other relevant material; (3) May consult individuals; (4) May consider comments from the staff; or (5) May require argument of the question or permit the introduction of evidence. B. Disposition. (1) A declaratory ruling issued shall be in writing, stating the: (a) Question; (b) Decision; (c) Description of factors considered; and (d) Sources relied upon. (2) A declaratory ruling issued by the Board shall plainly state that it is a declaratory ruling pursuant to these regulations. (3) A written answer from the Board or any employee of the Board to an inquiry may not be construed as a declaratory ruling unless made in conformity with these regulations. C. Publication and Inspection. (1) The Board shall keep a record of each declaratory ruling issued. (2) The Board may publish declaratory rulings of general interest subject to the mandates of the Public Information Act, State Government Article, §10-601 et seq., Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to the Public Information Act. D. The Board may refuse to consider a petition if the: (1) Request contains incomplete information upon which to base an informed declaratory ruling; (2) Board or its designee concludes that a declaratory ruling cannot reasonably be given on the matter; (3) Matter is adequately covered by a prior: (a) Regulation; (b) Declaratory ruling; (c) Decision; (d) Legal opinion; or (4) The Board or its designee concludes that a ruling would not be in the public interest. #### Regulation .04 Effect, Revision, and Appeal. *COMAR 10.27.08.04* A. Effect. A declaratory ruling shall be binding upon the Board and the petitioner on the statement of facts covered in the declaratory ruling and set forth in the petition. B. Revision. (1) The petitioner's application for revision of the declaratory ruling shall: (a) Be filed within 10 days after the issuance of the declaratory ruling; and (b) State the grounds for the revision; (2) Upon receipt of the application, the Board may: (a) Open the declaratory ruling to receive additional information; (b) Amend its ruling or its statement or reasons for the ruling; (c) Set forth additional findings or reasons; (d) Enter new findings, new reasons, or a new ruling. (3) The Board shall grant or deny the application within 90 days of its submission. (4) The Board may exercise revisory power and control over the declaratory ruling in the case of fraud, mistake, or irregularity. C. Appeal. A declaratory ruling is subject to review as provided in State Government Article, §10-305, Annotated Code of Maryland. ### Chapter 09 — Standards of Practice for Registered Nurses **Authority:** Health-General Article, §4-403; Health Occupations Article, §§8-205 and 8-316, Annotated Code of Maryland **Administrative History:** Effective date: February 20, 1989 (16:3 Md. R. 343) **Administrative History:** Regulation .03 amended effective October 25, 1993 (20:21 Md. R. 1654) **Administrative History:** Regulations .01—.03 repealed and new Regulations .01—.03 adopted effective April 3, 2000 (27:6 Md. R. 642) **Administrative History:** Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .02G adopted effective October 13, 2025 (52:20 Md. R. 1002) **Administrative History:** Regulation .04 adopted effective March 17, 2014 (41:5 Md. R. 346) #### Regulation .01 Definitions. *COMAR 10.27.09.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accountability” means being answerable for the actions of self and others. (2) “Aggregate” means the sum total of nursing care the client received. (3) “Assessment” means a systematic, dynamic process by which the nurse, through interaction with the client, family, significant others, and other health care providers, collects and analyzes data. (4) “Assign” means the transfer of responsibility from one nurse to another with each nurse having the legal authority to perform the function as permitted by the licensee's scope of practice. (5) “Client” means an individual, family, group, or community under the licensee's direct or indirect care. (6) “Continuity of care” means an interdisciplinary process that: (a) Includes the client, family, and significant other in the development and communication of a coordinated plan of care; and (b) Based on changing needs and available resources, facilitates the client's: (i) Care within a setting, and (ii) Transition between settings. (7) “Criteria” means relevant, measurable indicators of the standards of registered nurse practice. (8) “Delegate” means the registered nurse: (a) Invests authority to act on behalf of the registered nurse to an unlicensed person; (b) Authorizes the unlicensed person to augment and supplement the care the registered nurse provides; and (c) Retains the accountability and responsibility for the delegated act. (9) “Evaluation” means the review and analysis of the extent to which the assessment, nursing diagnosis, planning, and implementation is effective in resolving the client's health problems or progress toward the attainment of expected outcomes. (10) Health Care Providers. (a) “Health care provider” means an individual with special expertise who provides health care services or assistance to clients. (b) “Health care provider” includes: (i) Nurses; (ii) Physicians; (iii) Psychologists; (iv) Social workers; (v) Nutritionists/dietitians; and (vi) Various therapists. (11) “Health care team” means a group of individuals, which includes health care providers and unlicensed personnel, working in collaboration with the client, family, and significant others to achieve identified outcomes. (12) Health Status Data. (a) “Health status data” means information obtained through nursing assessment of the client. (b) “Health status data” includes but is not limited to: (i) Growth and development; (ii) Biophysical status; (iii) Emotional status; (iv) Cultural, religious, and socioeconomic background; (v) Activities of daily living and instrumental activities of daily living; (vi) Patterns of coping; (vii) Interaction patterns; (viii) Client perception of and degree of satisfaction with health status; (ix) Client health goals; (x) Physical, social, emotional, and ecological environments; and (xi) Access to and availability of human and material resources. (13) “Implementation” means the process of performing, delegating, assigning, supervising, and coordinating interventions. (14) “Instrumental activities of daily living” means home management skills such as shopping for food and personal items, preparing meals, or handling money. (15) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (16) “Nursing diagnosis” means a description of the actual or potential, overt or covert health problems which registered nurses are licensed to treat. (17) “Outcomes” means measurable, expected, client-focused goals which translate into observable behaviors. (18) “Plan of care” means designing methods to solve identified problems and to attain outcomes by means of establishing priorities, setting goals, and defining interventions. (19) “Process” means the delivery of care and the fulfillment of the practice standards. (20) “Quality of care” means the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge. (21) “Recipients of nursing care” means individuals, families, groups, communities, or populations. (22) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (23) “Responsibility” means the obligation and duty to perform. (24) “Scientific principles” means a fundamental belief or reason for action derived from an organized system of study. (25) “Standards of care” means a minimum level of competent nursing practice demonstrated through assessment, analysis, formulation of nursing diagnosis, outcome identification, planning, implementation, and evaluation. (26) Standards of Registered Nurse Practice. (a) “Standards of registered nurse practice” means the minimum criteria the registered nurse shall adhere to in the practice of registered nursing. (b) “Standards of registered nurse practice” includes both standards of care and standards of professional performance. (27) Standards of Professional Performance. (a) “Standards of professional performance” means a competent level of behavior in the professional role. (b) “Standards of professional performance” includes activities related to: (i) Quality of care; (ii) Performance appraisal; (iii) Education; (iv) Collegiality; (v) Ethics; (vi) Collaboration; (vii) Research; (viii) Resource utilization; (ix) Assignment; (x) Delegation and supervision; and (xi) Refusal. (28) “Structure” means: (a) The environment in which care is provided; and (b) Resources available to provide care including but not limited to finances, staffing, supplies, equipment, and medical records. (29) “Technology assessment” means a review of drugs, devices, procedures, and systems in relationship to their safety, effectiveness, and economic and social impact. #### Regulation .02 Standards of Care. *COMAR 10.27.09.02* A. Assessment. (1) The RN shall collect client health data. (2) Measurement Criteria. (a) Data collection shall involve the client, family, significant others, other members of the health care team, and the health record, when appropriate. (b) Data may include the following dimensions: (i) Physical; (ii) Psychological; (iii) Sociocultural; (iv) Spiritual; (v) Cognitive; (vi) Functional abilities; (vii) Developmental; (viii) Economic; (ix) Technology; and (x) Life-style. (3) Priority of data collection is determined by the client's immediate condition or needs, health status, and setting. (4) Pertinent data shall be collected using appropriate assessment techniques. (5) Data collection shall include a technology assessment. (6) The data collection process shall be comprehensive, systematic, and ongoing. (7) Relevant health status data, including changes, shall be documented in an authorized record which is accessible and in a retrievable form. B. Analysis and Nursing Diagnosis. (1) The RN shall analyze the assessment data in determining nursing diagnoses. (2) Measurement Criteria. (a) The RN shall analyze the data, consider the options, including technology, and make a determination as to whether the selected options are appropriate for the needs of the client. (b) Nursing diagnoses shall be: (i) Derived in a complete, systematic, and ongoing manner from the assessment data; (ii) Validated with the client, family, significant others, and other members of the health care team, when possible; and (iii) Documented in a manner that facilitates the determination of expected outcomes and plan of care. (c) Nursing diagnoses shall identify the nature and extent of the client's health status, capabilities, and limitations. C. Outcome Identification. (1) The RN shall identify expected outcomes individualized to the client. (2) Measurement Criteria. (a) Outcomes shall be: (i) Derived in a comprehensive, systematic, and ongoing manner from the diagnoses; (ii) Directed toward management of the client's health problems; (iii) Formulated with the client, family, significant other, or other members of the health care team, when possible and appropriate; (iv) Culturally appropriate and realistic in relation to the client's present and potential capabilities; (v) Attainable in relation to the resources available to the client; (vi) Documented as measurable goals with time estimates for attainment as appropriate; and (vii) Documented in an authorized record which is accessible and in a retrievable form. (b) Outcomes provide direction for continuity of care. D. Planning. (1) The RN shall develop a plan of care that prescribes interventions to attain expected outcomes. (2) Measurement Criteria. (a) The plan shall be: (i) Individualized in a comprehensive, systematic and ongoing manner; (ii) Developed utilizing available data; (iii) Prioritized to meet the client's condition or needs; (iv) Developed, coordinated, and communicated with the client, family, significant other, and other members of the health care team as appropriate; (v) Congruent with the client's therapeutic regime; and (vi) Documented. (b) The plan shall: (i) Reflect current nursing practice; (ii) Provide for continuity of care; and (iii) Include identification, coordination, and utilization of available resources. E. Implementation. (1) The RN shall implement the interventions identified in the plan of care. (2) Measurement Criteria. (a) Interventions shall be: (i) Implemented recognizing the rights of the client, the family, and significant others; (ii) Consistent with the established plan of care; (iii) Implemented in a competent, safe, and appropriate manner consistent with knowledge of scientific principles; and (iv) Documented. (b) Interventions may include, but are not limited to: (i) Patient teaching; (ii) Counseling; (iii) Implementing clinical practice guidelines, protocols, and pathways; and (iv) Independent nursing functions. (c) Selected interventions may be assigned and delegated to other personnel participating in delivering care. (d) When assignment or delegation occurs, supervision is provided. (e) A safe and therapeutic environment is provided for the delivery of nursing care. (f) Relevant information which may be needed to carry out the nursing plan is provided to the client, family, significant others, and other members of the health care team without violating the client's confidentiality. F. Evaluation. (1) The RN shall evaluate the client's progress toward attainment of outcomes. (2) Measurement Criteria. (a) Evaluation shall be systematic, ongoing, and criterion-based. (b) The client, family, significant other, and other members of the health care team shall be involved in the evaluation process, when appropriate. (c) Ongoing assessment data shall be used to evaluate the process of care and to revise the nursing diagnosis, outcomes, and the plan of care. (d) Revisions of diagnoses, outcomes, and the plan of care shall be documented. (e) The effectiveness of interventions shall be evaluated in relation to outcomes. (f) The responses to interventions shall be documented and communicated to the client and other members of the health care team. (g) The RN charged with the documentation of the client's discharge shall make the final nursing evaluation. G. Documentation. The RN shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .03 Standards of Professional Performance. *COMAR 10.27.09.03* A. Quality of Care. (1) The RN systematically shall evaluate the quality and effectiveness of nursing practice in the aggregate. (2) Measurement Criteria. The RN shall: (a) Participate in activities to evaluate quality of care including, but not limited to, monitoring the structure, process, and outcome of nursing practice, with consideration for access and cost; (b) Use quality monitoring data to identify opportunities for improving care; and (c) Participate in activities related to implementing changes designed to improve care. B. Performance Appraisal. (1) The RN shall be accountable for evaluating the RN's own nursing practice on a regular basis in relation to professional practice standards and relevant statutes and regulations. (2) Measurement Criteria. (a) The RN shall: (i) Participate in peer review as appropriate; and (ii) Seek guidance, support, education, and supervision as necessary. (b) The RN shall demonstrate knowledge of and shall comply with: (i) Relevant professional practice standards; (ii) Statutes and regulations governing nursing; and (iii) The policies and procedures of the practice setting. C. Education. (1) The RN shall acquire and maintain current knowledge and competency in nursing practice. (2) Measurement Criteria. The RN shall: (a) Participate in educational opportunities and experiences to maintain professional competence; and (b) Obtain knowledge and skills appropriate to the practice setting. D. Collegiality. (1) The RN shall contribute to the professional development of peers, colleagues, and others. (2) Measurement Criteria. (a) The RN shall share knowledge and skills with peers, colleagues, and others. (b) The RN shall contribute to a supportive and healthy work environment. E. Ethics. (1) The RN's decisions and actions shall reflect ethical principles. (2) Measurement Criteria. The RN shall: (a) Comply with the Code of Ethics in COMAR 10.27.19; (b) Maintain client confidentiality within legal and regulatory standards; (c) Act as a client advocate and assist clients to advocate for themselves; (d) Deliver care in a nonjudgmental and nondiscriminatory manner that is sensitive to client diversity; (e) Deliver care in a manner that preserves client autonomy, dignity, and rights; and (f) Seek available resources to help formulate ethical decisions. F. Collaboration. (1) The RN shall collaborate with the client, family, significant others, and other health care providers in providing care. (2) Measurement Criteria. The RN shall: (a) Collaborate with the client, family, significant others, and other health care providers in the formulation of overall goals, the plan of care, and decisions related to care and the delivery of services; and (b) Consult with health care providers for client care. G. Research. (1) The RN shall participate in research activities appropriate to the licensee's position, education, and practice environment. (2) Measurement Criteria. The RN shall: (a) Support the client's rights related to research; (b) Participate in data collection; (c) Participate in identification of clinical problems suitable for nursing research; and (d) Utilize established facility-approved research protocols. H. Resource Utilization. (1) The RN shall consider factors related to safety, effectiveness, and cost in planning and delivering client care. (2) Measurement Criteria. The RN: (a) Shall assist the client, family, and significant others in identifying services and options available to address health-related needs; (b) Shall evaluate factors related to safety, effectiveness, and cost when performing, assigning, delegating, and supervising nursing care, and teaching the client, family, and significant others; and (c) As a case manager, may identify and facilitate options and services for meeting individual health needs by enhancing quality, cost-effective clinical outcomes while decreasing fragmentation and duplication of care. I. Assignment, Delegation, and Supervision. (1) The RN may assign nursing acts or delegate nursing tasks to individuals who are competent to perform those acts or tasks, when the assignment or delegation does not jeopardize the client's welfare. (2) Measurement Criteria. (a) When delegating a nursing task to an unlicensed person, the RN shall assess the client and determine that the delegation is consistent with COMAR 10.27.11. (b) When delegating a nursing task to an unlicensed person, the registered nurse shall: (i) Instruct; (ii) Direct; (iii) Regularly evaluate the performance of nursing tasks by the unlicensed person; (iv) Rectify a situation in which the unlicensed person under the licensee's supervision is performing nursing tasks incorrectly; and (v) Prohibit the continued performance of an unlicensed person who is performing the delegated nursing task or tasks incompetently. (c) When the RN is assigning a nursing act to another licensed nurse, the RN shall: (i) Verify that the nursing act is within the licensed nurse's legal scope of practice; (ii) Verify that the licensed nurse has the knowledge, skills and clinical competency to perform the assigned act; (iii) Verify that the assigned act is consistent with the facility's policies and procedures; (iv) Regularly evaluate the licensed nurse who is performing the assigned nursing act; (v) Rectify a situation in which the licensed nurse assigned to perform the nursing act has performed the nursing act incorrectly; and (vi) Prohibit the continued performance of the assigned nursing act by a licensed nurse who is performing the assigned nursing act or acts incompetently. J. Refusal. (1) The RN has the right and the responsibility to refuse to perform, assign, or delegate nursing acts. (2) Measurement Criteria. (a) The RN has the right and responsibility to refuse to perform a nursing act which is beyond the parameters of the nurse's education, capabilities, and clinical competency. (b) The RN shall obtain appropriate education, training, and supervision as required to perform nursing functions which are beyond the parameters of the nurse's education and clinical competence. (c) The RN has the right to refuse to accept responsibility and accountability for supervising, monitoring, instructing, or evaluating an unlicensed person performing a nursing task that has not been delegated by that nurse. #### Regulation .04 Specialty Practice. *COMAR 10.27.09.04* A. A registered nurse functioning in a specialty practice shall have additional education, training, and experience. Specialty practice does not include advanced practice nursing. B. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Terms Defined. (a) “Critically ill client” means a client who: (i) Has developed or is at high risk for developing life threatening problems; (ii) Requires constant intensive multidisciplinary assessment and intervention to restore stability and prevent complications; and (iii) Needs restoration or maintenance of physiologic stability. (b) “Interfacility specialty care transport” means the movement of a critically ill client by transport vehicle when the client’s level of care requires the care of a registered nurse during transport. (c) On-Line Medical Direction. (i) “On-line medical direction” means oversight and orders by licensed physicians at base stations to EMS providers or members of the transport team providing patient care at an Advanced Life Support (ALS) or Basic Life Support (BLS) level. (ii) “On-line medical direction” includes medical orders and oversight by a licensed practitioner at a specialty care unit at a hospital to a registered nurse during a specialty care transport, provided the licensed practitioner is permitted by the facility to provide these services and the services are within the scope of the individual’s license. (d) Licensed Practitioner. (i) “Licensed practitioner” means a dentist, physician, nurse practitioner, nurse anesthetist, or nurse midwife or any other individual permitted by law and the facility to provide care and services within the scope of the individual’s license. (ii) “Licensed practitioner” does not include a student in a graduate education program whose practice requires supervision and whose orders must be countersigned. (e) “Specialty care transport” means transport for all ages of critically ill clients in accordance with the definitions under COMAR 30.09.01.02. C. Practice Specialty Care Transport. (1) Education, Training, and Experience Requirements. Except for the provisions under §C(2) and (4) of this regulation, a registered nurse who provides interfacility specialty care transport shall meet the education, training, and experience requirements for staffing an interfacility specialty care transport mission in accordance with COMAR 30.09.14.02G(1)—(3). (2) When a specialty care transport ambulance is not available within a clinically reasonable time, a registered nurse who has not completed a program of study in accordance with COMAR 30.09.14.02G(1)—(3) for the transport of patients by ambulance can provide interfacility specialty care, if: (a) The registered nurse has education, training, and experience in the critical care area required by the mission as determined by the referring physician; (b) The registered nurse is accompanied by an individual who is currently licensed as a Maryland ALS provider, in accordance with COMAR 30.02.02, to support the registered nurse with the transport; and (c) On-line medical direction is available to the registered nurse. (3) A registered nurse providing specialty care transport who does not have national certification for working with the client population to be transported shall have at least: (a) 2 years of clinical nursing experience in critical or specialty care within the last 5 years; (b) Age appropriate advanced life support training; and (c) Nursing expertise in the specialty care area required by the client’s age and diagnosis. (4) This regulation does not apply to, restrict, or limit: (a) Other health care practitioners who are authorized to perform these duties under their respective laws; or (b) A registered nurse providing care to a critically ill patient during a declared natural disaster or emergency. (5) A registered nurse is prohibited from accepting a transport assignment that exceeds the nurse’s knowledge and expertise. ### Chapter 10 — Standards of Practice for Licensed Practical Nurses **Authority:** Health-General Article, §4-403; Health Occupations Article, §§8-205(a)(2) and 8-316, Annotated Code of Maryland **Administrative History:** Effective date: February 20, 1989 (16:3 Md. R. 343) **Administrative History:** Regulation .03 amended effective October 25, 1993 (20:21 Md. R. 1655) **Administrative History:** Regulations .01—.03 repealed and new Regulations .01—.04 adopted effective May 2, 2011 (38:9 Md. R. 553) **Administrative History:** Regulation .01B amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .02C amended effective October 13, 2025 (52:20 Md. R. 1002) #### Regulation .01 Definitions. *COMAR 10.27.10.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Assessment” means the act of gathering and identifying data about the client. (2) “Assign” means the transfer of responsibility from one nurse to another, each having legal authority to perform the function as permitted by the licensee’s scope of practice. (3) “Board” means the Board of Nursing. (4) “Case management” means a collaborative process that assesses, plans, implements, coordinates, monitors, and evaluates options and services to meet the client’s health needs through enhanced communication and use of available resources to promote quality client outcomes and cost effective care. (5) “Client” means an individual who is under the licensee’s direct or indirect care. (6) Comprehensive Nursing Assessment. (a) “Comprehensive nursing assessment” means an assessment performed by a registered nurse which is the foundation for the analysis of the assessment data to determine: (i) The nursing diagnosis; (ii) Expected client outcomes; and (iii) The client’s plan of care. (b) “Comprehensive nursing assessment” includes, but is not limited to: (i) Extensive initial and ongoing data collection for individuals, families, groups, and communities; (ii) A focused nursing assessment; (iii) Past history, current health status, and potential changes in the client’s condition; (iv) Identification of alterations to the client’s previous condition; and (v) Synthesis of the biological, psychological, spiritual, and social aspects of the client’s condition. (7) “Contributes” means to participate as a team member in the nursing team relationship. (8) “Delegating” means the act of authorizing an unlicensed individual, a certified nursing assistant, or a certified medication technician to perform selected acts of registered nursing or licensed practical nursing. (9) “Evaluation” means the review and analysis of the extent to which the assessment, planning, and implementation were effective in resolving the client’s health problem. (10) Focused nursing assessment. (a) “Focused nursing assessment” means an appraisal of a client’s current health status and situation at hand; (b) “Focused nursing assessment” includes the reporting of information to other members of the health care team. (11) “Goal” means a measurable result to be achieved by a client which is either long- or short-term. (12) “Implementation” means the carrying out of the nursing plan of care. (13) “Licensed nurse” means a licensed practical nurse or registered nurse. (14) “Licensed practical nurse (LPN)” means an individual who is licensed by the Board to practice licensed practical nursing or holds a multistate licensure privilege to practice licensed practical nursing. (15) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (16) “Nursing plan of care” means an established set of goals, priorities, and methods designed to solve, prevent, and manage a client’s identified problems. (17) “Nursing team relationship” means that each licensed or certified individual who participates in providing care for a client is a part of the nursing team. (18) “ Nursing triage” means the systematic collection of client data at the client’s point of entry or re-entry into the health care system for the purpose of sorting clients by acuity levels to determine the allocation of available health care resources to direct each client to the right health care provider at the right time. (19) “Record” means a written retrievable document containing the client’s health information. (20) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Who holds a multistate licensure privilege to practice registered nursing. (21) Standards of Licensed Practical Nurse Practice. (a) “Standards of licensed practical nurse practice” means the minimum criteria to which the licensed nurse shall adhere in the practice of licensed practical nursing. (b) “Standards of licensed practical nurse practice” includes standards of professional performance as described in Regulation .03 of this chapter. (22) “Supervision” means the process of critically watching an individual’s performance with the intention of evaluating and directing the individual’s performance in the delivery of nursing care. (23) “Support” means to promote, assist, or help. #### Regulation .02 Nursing Process. *COMAR 10.27.10.02* A. In a team relationship the licensed practical nurse contributes to the nursing process. The nursing process shall include, but is not limited to, the following elements listed in §B—C of this regulation. B. Nursing Assessment. The LPN contributes to the nursing assessment by: (1) Collecting data for the assessment of the client: (a) Through direct observation; (b) From interviews with the client, client’s family, and significant others; (c) From the review of the client’s medical records including, but not limited to: (i) Past history; (ii) Laboratory studies; (iii) Medications; and (iv) Consultations; and (d) By assessing the environment; (2) Performing a focused nursing assessment of the client’s current conditions and problems or needs which includes: (a) The nursing interview; (b) A physical assessment; (c) The client’s common predictable, chronic, routine, recurrent health problems; and (d) Identification of any changes in the client’s symptoms and behavior; (3) Communicating the assessment on records that reflect: (a) Changes in the client’s health status; and (b) A continuous collection of data by updating and revising of the nursing assessment; and (c) Data recorded in a manner which is: (i) Complete, timely, and accurate; (ii) Consistent with general standards of nursing practice; and (iii) Consistent with the facility’s policies and procedures. C. Nursing Plan of Care. (1) Development. The LPN contributes to the development of the nursing plan of care by: (a) Reporting ongoing data collection; (b) Reporting changes that include, but are not limited to, the client’s; (i) Condition; (ii) Changed goals; and (iii) Changed priorities; (c) Making recommendations to individualize interventions specific to the client; (d) Reporting communication with; (i) The client; (ii) The client’s family; (iii) Significant others; and (iv) Other members of the health care team; and (e) Documenting in appropriate records. (2) Implementation. The LPN participates in the implementation of the nursing plan of care by: (a) Continuing to collect and report data; (b) Assisting in the coordination of client care with other health care team members as directed by the RN; (c) Implementing standardized or RN developed teaching plans under the direction of the RN; (d) Contributing to the nursing case management by: (i) Implementing assigned components of the nursing care plan; and (ii) Continuing to collect and report data regarding the implemented plan including the client’s response to intervention and problem identification; (e) Contributing to nursing management and supervision of the certified nursing assistant and unlicensed personnel by: (i) Assuring nursing functions are performed competently and timely; and (ii) Reporting to the leader of the nursing team; and (f) In accordance with the nursing team’s plan of care for the client and with COMAR10.27.11, delegating acts of the LPN’s practice to: (i) The certified nursing assistant; (ii) The certified medication technician; and (iii) Unlicensed personnel; (g) Performing nursing interventions in a competent safe manner appropriate to the LPN’s scope of practice including: (i) Administration of medications and treatments; (ii) Administration of infusion therapy consistent with COMAR 10.27.20; and (iii) Nursing intervention consistent with any declaratory rulings and regulations issued by the Board; (h) Documenting implementation of nursing care timely, completely, and accurately; and (i) Utilizing identified nursing approaches which include, but are not limited to: (ii) Reflecting knowledge of scientific principles; (iii) Recognizing the rights of the client, the client’s family, and significant others; and (iv) Providing a safe and therapeutic environment. (3) Evaluation. The LPN contributes to the evaluation of the nursing plan of care by: (a) Collecting and communicating data on the client’s goal achievement; (b) Assisting in identifying barriers to the client’s meeting any identified goal; (c) Reporting to other members of the health care team in a timely, accurate, and complete manner on data collected from; (i) The client; (ii) The client’s family; (iii) Significant others; and (iv) Other health care providers; (d) Assisting in evaluating the client’s competency in performing any treatment and self administering medication by utilizing established competency based evaluation tools; (e) Making recommendations regarding modification of the teaching nursing plan based on the client’s response; (f) Making recommendations regarding any revision to the nursing plan of care; and (g) Documenting the evaluation data on appropriate records. (4) Nursing Team Relationship. (a) The LPN as a part of the nursing team: (i) Functions as a team member under the leadership of the RN who is the team leader; (ii) Participates in providing care for the client; and (iii) Provides care for the client to the fullest extent allowed by the LPN’s scope of practice. (b) Each licensed nurse has responsibility for oversight or supervision of nursing practice appropriate to his or her level of licensure which includes critically watching, instructing, directing, and evaluating anothers nursing practice. (5) Documentation. The LPN shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .03 Standards of Professional Performance. *COMAR 10.27.10.03* A. Quality of Care. (1) The LPN shall participate in evaluating the quality and effectiveness of nursing practice. (2) Measurement Criteria. The LPN shall: (a) Assist in collecting quality data; and (b) Participate in activities related to implementing changes designed to improve care. B. Performance Appraisal. (1) The LPN shall be accountable for evaluating the LPN’s own nursing practice on a regular basis in relation to: (a) Relevant professional practice standards; and (b) Relevant statutes and regulations governing licensed practical nursing. (2) Measurement Criteria. (a) The LPN shall: (i) Participate in peer review as appropriate; and (ii) As necessary, seek guidance, support, education, and supervision. (b) The LPN shall demonstrate knowledge of and comply with: (i) Relevant professional practice standards; (ii) Relevant statutes and regulations governing licensed practical nursing; and (iii) The policies and procedures of the practice setting. C. Education. (1) The LPN shall acquire and maintain current knowledge and continued competency in the practice of licensed practical nursing. (2) Measurement Criteria. The LPN shall: (a) Participate in educational opportunities and experiences to maintain professional competence; and (b) Obtain knowledge and skills appropriate to the practice setting. D. Collegiality. (1) The LPN shall support the professional development of the: (a) Licensed practical nurse; (b) Certified nursing assistant; (c) Certified medication technician; and (d) Unlicensed personnel. (2) Measurement Criteria. (a) As directed by the RN, the LPN shall share knowledge and skills with: (i) Other LPNs; (ii) Certified nursing assistants; (iii) Certified medication technicians; and (iv) Unlicensed personnel. (b) The LPN shall contribute to a supportive and healthy work environment. E. Ethics. (1) The licensed practical nurse’s decisions and actions shall reflect ethical principles. (2) Measurement Criteria. The LPN shall: (a) Comply with the Code of Ethics as described in COMAR 10.27.19; (b) Maintain client confidentiality within legal and regulatory standards; (c) Act as a client advocate; (d) Deliver care in a nonjudgmental and nondiscriminatory manner that is sensitive to client diversity; (e) Deliver care in a manner that preserves the client’s; (i) Autonomy; (ii) Dignity; and (iii) Rights; (f) Communicate with the RN regarding potential ethical issues; and (g) Communicate to the RN, observations of actions by other health care providers which may jeopardize the client’s safety and well being. F. Collaboration. (1) The LPN shall participate with the client, the client’s family, significant others, the RN, and other health care providers in providing care. (2) Measurement Criteria. The LPN shall: (a) Participate with the client, the client’s family, significant others, the RN, and other health care providers by contributing to: (i) The development of overall goals; (ii) The nursing plan of care; and (iii) Decisions related to care and the delivery of services; and (b) Consult with the RN and other health care providers regarding client care. G. Research. (1) The LPN shall support research activities appropriate to the LPN’s scope of practice. (2) Measurement Criteria. The LPN shall: (a) Have knowledge of the client’s rights related to research; (b) Participate in data collection; and, (c) Utilize established facility-approved research protocols. H. Resource Utilization. (1) The LPN shall consider factors related to safety and cost when participating in client care planning and implementing client care. (2) Measurement Criteria. The LPN shall: (a) Assist the client, the client’s family, and significant others to identify: (i) Unmet client needs; and (ii) Potential services to meet any unmet needs; and (b) Evaluate factors related to client safety and cost when performing or delegating client care. I. Delegation and Supervision. (1) When the delegation does not jeopardize the client’s welfare, the LPN may delegate nursing tasks to a certified nursing assistant, medication technician, or an unlicensed person who is competent to perform those acts or tasks. (2) Measurement Criteria. (a) When delegating a nursing task, the LPN shall assess the client and determine that the delegation is consistent with COMAR 10.27.11. (b) When delegating nursing tasks, the LPN shall assess the capabilities, experience, and competency of a person working under the LPN’s supervision. (c) When delegating a nursing task to a certified nursing assistant, medication technician, or an unlicensed person, the LPN shall: (i) Instruct; (ii) Direct; (iii) Regularly evaluate the performance of nursing tasks by the certified nursing assistant, medication technician, or unlicensed person; (iv) Rectify a situation in which the certified nursing assistant, medication technician, or unlicensed person under the LPN’s supervision is performing nursing tasks that are inconsistent with generally accepted professional standards and notify the registered nurse leader of the nursing team; and (v) Prohibit the continued performance of the certified nursing assistant, medication technician, or unlicensed person who is performing the delegated nursing task or tasks incompetently and notify the registered nurse leader of the nursing team. J. Refusal. (1) The LPN has the right and the responsibility to refuse to perform, or delegate nursing acts. (2) Measurement Criteria. (a) The LPN has the right and responsibility to refuse to perform a nursing act which is beyond the parameters of the LPN’s: (i) Education; (ii) Capabilities; (iii) Clinical competency; and (iv) Scope of practice. (b) The LPN shall obtain appropriate education, training, and supervision as required to perform nursing functions which are within the LPN’s scope of practice but are beyond the parameters of the licensee’s clinical competency. (c) The LPN has the right to refuse to accept responsibility and accountability for supervising, monitoring, instructing, or evaluating a certified nursing assistant, certified medication technician, or an unlicensed person performing a nursing task that has not been delegated by that licensee. #### Regulation .04 Prohibited Acts. *COMAR 10.27.10.04* The LPN may not: A. Perform nursing triage; B. Perform the responsibilities of, or serve in the role of, the circulating nurse in the intraoperative phase of surgery including, but not limited to: (1) Assessing the client in the intraoperative phase of surgery to identify emerging client situations which would require anticipating and responding to the needs of the: (a) Client; (b) Anesthesiologist; and (c) Surgical team; (2) Administering or transporting to the surgical field medications, infusates, or solutions that may be required by the anesthesia or surgical team during the course of the intraoperative procedure; (3) Gathering needed equipment and anticipating resuscitation efforts during the intraoperative phase; (4) Collaborating with other members of the surgical team for ongoing assessment and planning for the client’s postoperative care; and (5) Documenting completely, timely, and accurately on appropriate records; C. Perform the comprehensive nursing assessment; D. Serve as the case manager for client care; E. Supervise the nursing practice of RNs and other LPNs; and F. Analyze client data in order to determine client outcome identification and formulation of a nursing diagnosis. ### Chapter 11 — Delegation of Nursing Functions **Authority:** : Health Occupations Article, §§8-102, 8-205, 8-6A-01, 8-6A-02, 8-6A-03, 8-6A-05(a)(4), and 8-6A-08(f)(5), Annotated Code of Maryland **Administrative History:** Effective date: October 2, 1989 (16:19 Md. R. 2105) **Administrative History:** Regulations .01—.06 amended as an emergency provision effective February 5, 1992 (19:4 Md. R. 468); emergency status expired August 7, 1992 **Administrative History:** Regulations .01—.06 amended permanently effective August 8, 1992 (19:11 Md. R. 1015) **Administrative History:** Regulations .02—.06 amended effective July 4, 1994 (21:13 Md. R. 1158) **Administrative History:** Regulations .01—.06 repealed and new Regulations .01—.06 adopted effective May 10, 2004 (31:9 Md. R. 712) **Administrative History:** Regulation .01H adopted as an emergency provision effective July 8, 2015 (42:16 Md. R. 1053); adopted permanently effective July 20, 2015 (42:14 Md. R. 880) **Administrative History:** Regulation .01I adopted effective August 4, 2025 (52:15 Md. R. 812) **Administrative History:** Regulation .02B amended effective February 28, 2005 (32:4 Md. R. 411); January 26, 2009 (36:2 Md. R. 101); September 19, 2011 (38:19 Md. R. 1147); July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03 amended effective June 29, 2009 (36:13 Md. R. 900) **Administrative History:** Regulation .04 amended effective January 26, 2009 (36:2 Md. R. 101) **Administrative History:** Regulation .04C, D amended effective September 19, 2011 (38:19 Md. R. 1147) **Administrative History:** Regulation .05 amended effective February 28, 2005 (32:4 Md. R. 411); January 26, 2009 (36:2 Md. R. 101) **Administrative History:** Regulation .05H amended effective September 19, 2011 (38:19 Md. R. 1147) **Administrative History:** Regulation .06C, D amended effective January 26, 2009 (36:2 Md. R. 101) #### Regulation .01 Exclusion from Regulations. *COMAR 10.27.11.01* This chapter is not applicable to and does not restrict or limit: A. Other health care practitioners who are authorized delegatory powers under their respective acts; B. The gratuitous provision of care by self, family, or friends; C. Provision of care by a child care provider employed in the child's home by the child's parent or by a child care provider licensed by the Child Care Administration under COMAR 07.04.01 (Family Day Care) or COMAR 07.04.02 (Child Care Center Licensing) except for those providers enrolling a majority of children with health or medical conditions or both; D. The cognitively capable adult from employing an unlicensed caregiver in the adult's home to assist the adult in treatments of a routine nature and in self-administration of medication; E. An individual who performs nursing assistant tasks while a nursing student enrolled in an accredited nursing education program and practicing under the direct supervision of: (1) Qualified faculty or preceptors; or (2) A nurse while working as a nursing assistant; F. An individual who performs nursing assistant tasks as a student while: (1) Enrolled in a Board-approved nursing assistant training program; (2) Practicing under the direct supervision of qualified faculty or preceptors; or (3) Practicing under the direct supervision of a nurse while working as a nursing assistant; G. A nurse from delegating a nursing task to an unlicensed individual if acceptance of delegated nursing tasks does not become a routine part of the unlicensed individual's job duties; or H. A youth camp regulated in accordance with COMAR 10.16.06. I. A certified dialysis technician regulated in accordance with COMAR 10.39.06. #### Regulation .02 Definitions. *COMAR 10.27.11.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accountability” means being answerable for actions of self or others. (2) “Board” means the Board of Nursing. (3) “Certified medicine aide (CMA)” means an individual who meets the requirements as stated in COMAR 10.39.01 and 10.39.03. (4) “Certified nursing assistant (CNA)” means an individual certified by the Board as a nursing assistant. (5) “Client” means the recipient of nursing care. (6) “Delegation” means the act of authorizing an unlicensed individual, a certified nursing assistant, or a medication technician to perform acts of registered nursing or licensed practical nursing. (7) “Evaluation” means the review and analysis of the extent to which the assessment, nursing diagnosis, planning, and implementation phases of the nursing process were effective in resolving the client's identified problems. (8) “Family” means related family members, foster parents, domestic partners, and legal guardians. (9) “Geriatric nursing assistant (GNA)” means a CNA who has successfully completed the requirements for a GNA set forth in 42 CFR §§483.151 — 483.156 and COMAR 10.39.01. (10) “Home health aide (HHA)” means a CNA who has successfully completed the requirements for certification as a HHA set forth in 42 CFR §484.36 and COMAR 10.39.01. (11) “Licensed practical nurse” means an individual who is licensed by the Board to practice licensed practical nursing or has a multistate licensure privilege to practice licensed practical nursing. (12) “Medication technician” means an individual who completes a 20-hour course in medication administration approved by the Board and is certified by the Board. (13) Model of Nursing Practice. (a) “Model of nursing practice” means the policies, procedures, and practice guidelines: (i) Established by the facility, which are consistent with this chapter regarding delegation of nursing functions and regulations governing the facility; and (ii) That provide direction to nursing staff on the delivery of care to the client population which the facility serves. (b) "Model of nursing practice” may not supersede a delegating nurse's prudent judgment regarding: (i) Delegation of a nursing function to a certified nursing assistant, an unlicensed individual, or a medication technician; or (ii) A particular delegated nursing function to that individual or individuals. (14) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (15) “Nurse” means a registered nurse or licensed practical nurse. (16) “Pressure ulcer” means a decubitus ulcer stage I through IV, the care for which includes cleaning, applying topical medication, and dressing without packing. (17) “Readily available” means, in: (a) A structured setting: (i) The delegating nurse is physically present on the unit; and (ii) The nurse may transfer responsibility for the nursing supervision and delegation to another nurse who then becomes the nurse delegating the nursing functions; and (b) Other settings, the delegating nurse is on the premises or else is available by telephone. (18) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (19) “Responsibility” means the charge to do something. (20) “Routine care” means those activities necessary on a daily basis for the client to gain or maintain a level of functioning. (21) “Structured setting” means a hospital, nursing home, long-term care facility, ambulatory care setting, surgicenter, or any other acute or chronic care facility. (22) “Supervised group living settings” means assisted living facilities, group homes for juveniles, group homes for emotionally disturbed children, alternative living units for the developmentally disabled, or any other facility or setting providing supervised living arrangements for groups of unrelated individuals. (23) “Supervision” means the process of critical watching, directing, and evaluating another's performance. (24) “Unlicensed individual” means an individual who is not licensed or certified to provide nursing care under Health Occupations Article, Title 8, Annotated Code of Maryland. (25) Wound. (a) “Wound” means venous stasis ulcer or ulcers, a dehissed wound, or any other break in the integrity of the full thickness of skin that involves the subcutaneous tissue or fascia. (b) “Wound” may include tunneling or a sinus tract. (c) “Wound” does not include an uncomplicated healing surgical wound. #### Regulation .03 Criteria for Delegation. *COMAR 10.27.11.03* A. The nurse may delegate the responsibility to perform a nursing task to an unlicensed individual, a certified nursing assistant, or a medication technician. The delegating nurse retains the accountability for the nursing task. B. A nursing task delegated by the nurse shall be: (1) Within the area of responsibility of the nurse delegating the act; (2) Such that, in the judgment of the nurse, it can be properly and safely performed by the unlicensed individual, certified nursing assistant, or medication technician without jeopardizing the client welfare; and (3) A task that a reasonable and prudent nurse would find is within the scope of sound nursing judgment. C. A nursing task delegated by the nurse may not require the unlicensed individual, certified nursing assistant, or medication technician to exercise nursing judgment or intervention except in an emergency situation. D. When delegating a nursing task to an unlicensed individual, certified nursing assistant, or medication technician the nurse shall: (1) Make an assessment of the patient's nursing care needs before delegating the task; (2) Either instruct the unlicensed individual, certified nursing assistant, or medication technician in the delegated task or verify the unlicensed individual's, certified nursing assistant's, or medication technician's competency to perform the nursing task; (3) Supervise the performance of the delegated nursing task in accordance with Regulation .04 of this chapter; (4) Be accountable and responsible for the delegated task; (5) Evaluate the performance of the delegated nursing task; and (6) Be responsible for assuring accurate documentation of outcomes on the nursing record. E. The nurse shall be the primary decision maker when delegating a nursing task to an unlicensed individual, certified nursing assistant, or medication technician. Nursing judgment shall be exercised within the context of the employing facility's model of nursing practice which includes a mechanism for: (1) Identifying those individuals to whom nursing tasks may be delegated; (2) Reevaluation of the competency of those to whom nursing tasks may be delegated; (3) Recognizing that the final decision regarding delegation is within the scope of the nurse's professional judgment; (4) Determining the competency of the nurse to delegate; and (5) Determining to whom nursing tasks may be delegated, which includes input by nurses employed in the facility. F. The registered nurse shall assume the role of case manager in delegating nursing tasks, including the administration of medications, only in accordance with Regulation .05G of this chapter in situations where the nurse has thoroughly assessed and documented that: (1) The client's health care needs are chronic, stable, uncomplicated, routine, and predictable; (2) The environment is conducive to the delegation of nursing tasks; and (3) The client is unable to perform his or her own care. #### Regulation .04 Supervision. *COMAR 10.27.11.04* A. The nurse shall determine the required degree of supervision after an evaluation of appropriate factors including, but not limited to the: (1) Stability of the condition of the client; (2) Training of the individual to whom the nursing task is being delegated; (3) Nature of the nursing task being delegated; (4) Orientation of the unlicensed individual, certified nursing assistant, or medication technician to the specific patient environment; (5) Ability of the unlicensed individual, certified nursing assistant, or medication technician to perform the delegated nursing task in a safe and competent manner; and (6) Reevaluation of the client's health status. B. The delegating nurse shall be readily available when delegating a nursing task to an unlicensed individual, certified nursing assistant, or medication technician. C. For the client whose health status meets the criteria as stated in Regulation .03F of this chapter, the registered nurse managing the case shall make a supervisory on-site visit to the client at a minimum of every 45 days to: (1) Evaluate the client's health status; (2) Evaluate the nursing acts to be delegated; (3) Determine whether health goals are being met; (4) Evaluate the continued competence of the certified nursing assistant, unlicensed individual, or medication technician to perform the delegated nursing task; and (5) Evaluate the environment in which the delegated task is performed. D. For the client whom the registered nurse has determined does not meet the criteria as stated in Regulation .03F of this chapter, the registered nurse shall: (1) Make a supervisory on-site visit to the client at least every 2 weeks to evaluate the criteria described in §C of this regulation; and (2) Determine whether the: (a) Nursing tasks may be safely delegated in that setting and given the client's clinical status; and (b) Nursing assistant, unlicensed individual, or medication technician is competent to perform the nursing tasks to be delegated. #### Regulation .05 Nursing Functions. *COMAR 10.27.11.05* A. The following nursing functions require nursing knowledge, judgment, and skill and may not be delegated: (1) The nursing assessment including, but not limited to, the admission, shift, transfer, or discharge assessment; (2) Development of the nursing diagnosis; (3) The establishment of the nursing care goal; (4) Development of the nursing care plan; (5) Evaluation of the client's progress, or lack of progress, toward goal achievement; and (6) Any nursing task which requires nursing knowledge, judgment, and skill. B. The nurse may delegate treatments of a routine nature if: (1) The licensed nursing staff of the specific unit of care has identified the function as being routinely performed; (2) The specific treatments are performed at a high frequency necessary to retain competency; (3) The treatment has an inherently low risk to the client; as determined by weighing the following factors: (a) Type of equipment utilized to perform the function; (b) Nurse staffing ratio that allows for close supervision; (c) Basic educational preparation of the unlicensed individual or certified nursing assistant performing the delegated function; and (d) Knowledge and skill set of the nurse delegating and supervising the delegated function; and (4) There is a quality assurance mechanism in place to assure the function is performed safely and client outcomes meet accepted professional nursing standards including, but not limited to: (a) An ongoing formalized documented performance appraisal mechanism designed to assure that unlicensed individual or certified nursing assistant's revalidation of continued competency is a component of the quality assurance mechanism; and (b) Client outcomes meeting accepted professional standards, as reflected by: (i) Infection rates; (ii) Rates of adverse events; (iii) Error rates; and (iv) Patient satisfaction surveys. C. The nurse may delegate the obtaining of specific information to an unlicensed individual or certified nursing assistant. D. When implementing the plan of care, the nurse may delegate a nursing task to an unlicensed individual or certified nursing assistant after the nurse has completed a client assessment and when the delegation of that task does not jeopardize the client's welfare. E. The nurse may delegate the responsibility to perform a nursing task to an unlicensed individual if: (1) Acceptance of the delegated nursing task does not become a routine part of the unlicensed individual's job duties; or (2) An unlicensed individual merely provides assistance with activities of daily living unless the client's needs are such that adverse health consequences are predictable. F. Administration of medication is a nursing function. As such, the nurse retains full responsibility for medication administration. G. The following activities related to medication administration may not be delegated except as provided in §H of this regulation: (1) Calculation of any medication dose; (2) Administration of medications by injection route; (3) Administration of medications by way of a tube inserted in a cavity of the body; and (4) Administration of medication by intravenous route. H. Delegation of Medication Administration. (1) The administration of medication as listed in §H(3) of this regulation may be delegated to certified medicine aides and medication technicians only in compliance with §H(2) of this regulation and when clients meet the requirements of Regulation .03F or .04D of this chapter in the following situations: (a) Supervised group living settings; (b) Supervised or sheltered work settings; (c) Independent living settings; (d) Schools; (e) Correctional institutions; (f) Hospice care; (g) Adult medical day care centers; and (h) Child care centers established for children with health or medical conditions or both. (2) A nurse may delegate to a medication technician or certified medicine aide under this section when: (a) The nurse has provided instruction and direction; and (b) The medication technician or certified medicine aide is on site in the unit of care on a continuing basis to: (i) Monitor the therapeutic effects of the medication; (ii) Observe, record, and report untoward effects of the medication; (iii) Perform monitoring procedures required for each medication; (iv) Observe for changes in the individual client's behavior and clinical status; (v) Record and report the changes observed to the delegating nurse; and (vi) Withhold administration of the medication. (3) A nurse may delegate administration of the following medications to a medication technician or a certified medicine aide according to Regulations .03F, .04C, and .05H(1) of this chapter: (a) Medication by metered dose inhalant, nebulizer, and oxygen by nasal cannula or mask; (b) Medication by gastrostomy tube or rectal tube if the nurse has calculated the dosage; (c) Oral medication, including: (i) Measuring as prescribed an amount of liquid medication where the nurse has calculated the dose; and (ii) Administering a fraction of a tablet if the nurse has cut the tablet; (d) Medication by subcutaneous injection if the nurse has calculated the dose; (e) Medication administered by topical route excluding stage III and IV pressure ulcers and wound care; (f) Medication administered by suppository route; (g) Medication drops administered by routes involving eye, ear, and nose; and (h) Where the registered nurse makes an on-site visit at least every 7 days to assess the client status and the performance of the medication technician's or certified medicine aide's administration of topical medication to stage three or four pressure ulcers or wounds. #### Regulation .06 Client Health Teaching and Health Counseling. *COMAR 10.27.11.06* A. The registered nurse shall be accountable and responsible for the development and initiation of the health teaching plan and for health counseling of the client. B. The nurse shall be accountable and responsible for facilitating and promoting: (1) Client education; and (2) Participation of the client and significant others in implementation of health goals. C. Unlicensed individuals, certified medicine aides, medication technicians, and certified nursing assistants given instruction and direction by the nurse may supplement the health teaching by providing standardized information to the client. D. The unlicensed individual, certified medicine aide, medication technician, and certified nursing assistant are responsible and accountable for reporting information to the nurse regarding the client's: (1) Request for information; and (2) Response to teaching provided by the nurse. ### Chapter 12 — Nurse Psychotherapists in Independent Practice — Clinical Nurse Specialists **Authority:** Health Occupations Article, §8-205, Annotated Code of Maryland **Administrative History:** Effective date: June 25, 1990 (17:12 Md. R. 1494) **Administrative History:** Regulation .07C adopted effective August 1, 1994 (21:15 Md. R. 1306) **Administrative History:** Chapter revised effective June 26, 2000 (27:12 Md. R. 1140) **Administrative History:** Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03B, C amended effective October 17, 2011 (38:21 Md. R. 1279) **Administrative History:** Regulation .04 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .05 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .07 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .08A, C amended effective July 2, 2018 (45:13 Md. R. 667) #### Regulation .01 Exclusion from Regulations. *COMAR 10.27.12.01* Nothing in this chapter shall be applicable to or restrict or limit a registered nurse from performing those functions which constitute the practice of registered nursing as defined by law. #### Regulation .02 Definitions. *COMAR 10.27.12.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as: (a) A certified nurse midwife (CNM); (b) A certified registered nurse anesthetist (CRNA); (c) A certified nurse practitioner (CRNP); or (d) A clinical nurse specialist (CNS). (2) “Board” means the Maryland Board of Nursing. (3) “Certification” means the permission to practice as a PMH/APRN granted by the Board to a registered nurse who has: (a) Met all the specified requirements of a national certifying body recognized by the Board; and (b) Complied with the requirements of this chapter. (4) “Mental health diagnosis” means the identification of a potential or an actual alteration in an individual's mental health status. (5) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (6) “Nurse psychotherapist” means a registered nurse, certified under this chapter, who utilizes psychotherapy in a formally structured, contractual relationship between the nurse therapist and a client. (7) “Psychiatric mental health/ advanced practice registered nurse (PMH/APRN)” means an advanced practice registered nurse who: (a) Is certified by the Board as a clinical nurse specialist in the practice of psychiatric mental health; and (b) Autonomously and independently engages in activities authorized by this chapter. (8) “Psychobiological interventions” means interventions which integrate physiological and psychological dimensions of care and include a range of therapies from diet/nutrition regulation, hypnosis, and relaxation techniques to the use of pharmacologic agents. (9) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. #### Regulation .03 Certification. *COMAR 10.27.12.03* An applicant for certification to practice as a PMH/APRN in independent practice shall: A. Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered nursing; B. Have graduated from a Board-approved graduate level education program for clinical nurse specialists in psychiatric mental health nursing at the Masters’ level or higher that is accredited by a national accrediting body recognized by the Board; C. Hold current national certification as a clinical nurse specialist in psychiatric or mental health nursing issued by the American Nurses Credentialing Center (ANCC) or any other national certifying body recognized by the Board; D. Submit to the Board a completed application for certification as a clinical nurse specialist, PMH/APRN; E. Comply with all the requirements set forth in COMAR 10.27.01.04; F. Demonstrate written and oral competency in the English language; and G. Pay all fees. #### Regulation .04 Practice Before Maryland Certification. *COMAR 10.27.12.04* A. A registered nurse who meets the qualifications to sit for a national certifying examination acceptable to the Board or who has taken that examination and is waiting for the results, may practice in this State as a PMH/APRN graduate if the: (1) Practice is under the supervision of a Maryland certified PMH/APRN who shall be readily available to the PMH/APRN graduate; (2) Supervising PMH/APRN agrees in a written supervision agreement on a form to be prescribed by the Board to provide the supervision; and (3) PMH/APRN graduate: (a) Completes the application for Maryland certification as a as a clinical nurse specialist in psychiatric mental health; and (b) Pays the certification application fee established by the Board in COMAR 10.27.01. B. A PMH/APRN graduate who has entered into a supervision agreement shall immediately notify the Board and the supervising PMH/APRN of the results of the national certifying examination. C. A PMH/APRN graduate may not continue to practice under supervision for more than 24 months from the filing of all documents required under §A of this regulation or after the denial of certification, whichever occurs first. #### Regulation .05 Scope of Practice. *COMAR 10.27.12.05* The PMH/APRN may perform independently, autonomously, and in a variety of settings, the following functions: A. Establish a mental health diagnosis; B. Evaluate and manage psychobiological intervention; C. Provide individual therapy; D. Provide group therapy; E. Provide family therapy; F. Provide any therapy which purpose is to: (1) Effect change in the client in an attempt to alleviate emotional disturbances, (2) Reverse or change maladaptive behavior, and (3) Facilitate personality growth and development; G. Provide consultation to health care providers and others to: (1) Influence the plans of care for clients, (2) Enhance the abilities of others to provide behavioral, psychiatric, and mental health care, and (3) Effect change in systems; H. Provide behavioral rehabilitation care; and I. Utilize advanced practice skills to independently provide: (1) Case management including psychiatric rehabilitation and home care, and (2) Health teaching, health promotion, health prevention, and aid to the client in developing healthy patterns of living. #### Regulation .06 Standards of Practice. *COMAR 10.27.12.06* A. Advanced practice skills shall be utilized in the collection of relevant data to comprehensively assess the client's mental health. B. Assessment data shall be analyzed in determining diagnosis. C. A plan of care shall be developed and implemented that outlines treatment to attain expected outcomes. D. Individual, group, and family psychotherapy, child psychotherapy, behavioral care, case management, and other therapeutic treatments shall be utilized to assist clients in fostering mental health, preventing mental illness and disability, and improving or regaining previous health status and functional abilities. E. Advanced knowledge of psychobiological interventions shall be utilized and clinical skills applied to maximize the client's health and prevent further disability. F. The use of psycholobiological interventions in this chapter does not authorize the prescription of medications. G. The client's progress in attaining the expected outcome shall be evaluated. H. Strategies and interventions shall be utilized to promote and maintain health and prevent mental illness. I. Decisions and actions on behalf of clients shall be determined in an ethical manner. #### Regulation .07 Renewal of Maryland Certification. *COMAR 10.27.12.07* A. Certification as a PMH/APRN expires at the same time as the license to practice registered nursing. B. Before a PMH/APRN’s certification expires, the PMH/APRN may renew the certification biennially if the PMH/APRN: (1) Is otherwise entitled to be certified; (2) Submits to the Board: (a) Documentation of a current national certification as a PMH/APRN from a national certifying body recognized by the Board; and (b) A completed renewal application on a form that the Board requires; and (3) Pays all fees. C. PMH/APRN renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J.—N. D. The PMH/APRN shall ensure that the Board has a record of the renewed national certification if the national certification expires before the registered nurse license renewal date. E. Certification as a PMH/APRN shall be deemed to have lapsed if the Board does not have a record of a current active national certification. F. Practicing on an expired national certification is prohibited and subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland. G. The Board shall maintain an up-to-date list of all PMH/APRNs certified in this State and include on the license an indication that the licensee is a PMH/APRN. #### Regulation .08 Unlawful Practices. *COMAR 10.27.12.08* A. Unless authorized to practice under this chapter, an individual may not use the words “advanced practice registered nurse/psychiatric mental health”, “nurse psychotherapist”, “psychiatric mental health/advanced practice registered nurse”, or any other words, letters, or symbols with the intent to represent that the individual is a psychiatric-mental health/advanced practice registered nurse. B. An individual certified under this chapter is subject to the disciplinary sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland. C. An individual may not practice as a PMH/APRN or nurse psychotherapist in this State unless the individual is certified under this chapter. ### Chapter 13 — Safe Practice Committee **Authority:** Health Occupations Article, §§8-205 and 8-208, Annotated Code of Maryland **Administrative History:** Effective date: July 20, 1992 (19:14 Md. R. 1283) **Administrative History:** Chapter revised effective March 5, 2001 (28:4 Md. R. 418) **Administrative History:** Chapter revised effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .01B amended effective August 4, 2025 (52:15 Md. R. 812) **Administrative History:** Regulation .02E amended effective August 4, 2025 (52:15 Md. R. 812) **Administrative History:** Regulation .03B amended effective August 4, 2025 (52:15 Md. R. 812) #### Regulation .01 Definitions. *COMAR 10.27.13.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means an individual who has submitted an application to the Board to be licensed as a registered nurse, licensed practical nurse, electrologist, licensed certified midwife or direct-entry midwife or to be certified as an advanced practice registered nurse, a certified nursing assistant, a certified dialysis technician, or medication technician in this State. (2) “Board” means the Maryland Board of Nursing. (3) “Committee” means the Safe Practice Committee. (4) “Certificate holder” means a certified nursing assistant, a certified dialysis technician, or medication technician. (5) “Certified dialysis technician” means an individual certified as a dialysis technician by the Board in accordance with COMAR 10.39.06. (6) “Certified nursing assistant” means an individual certified as a nursing assistant by the Board. (7) “Licensee” means a licensed certified midwife, direct-entry midwife, electrologist, licensed practical nurse, registered nurse, or advanced practice registered nurse. (8) “Licensed practical nurse” means an individual who is licensed by the Board to practice licensed practical nursing or has a multistate licensure privilege to practice licensed practical nursing. (9) “Medication technician” means an individual certified as a medication technician by the Board. (10) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (11) “Nurse” means registered nurse, advanced practice registered nurse, or licensed practical nurse. (12) “Participant” means a registered nurse, an advanced practice registered nurse, a licensed practical nurse, a certified nursing assistant, a certified dialysis technician, a medication technician, an electrologist, a licensed direct-entry midwife, a licensed certified midwife or an applicant enrolled in the Safe Practice Program. (13) “Program” means the Safe Practice Program. (14) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (15) “Substance use disorder” means a disorder that occurs when an individual exhibits a pattern of behaviors ranging from the misuse of, dependence on, or addiction to drugs, alcohol, or other chemicals. #### Regulation .02 Safe Practice Committee. *COMAR 10.27.13.02* A. Committee Appointments. (1) Annually, before the September meeting, the Board shall determine the number of rehabilitation committees required in the State. (2) The Board shall make appointments to the committee in October in accordance with Health Occupations Article, §8-208(c)(1), Annotated Code of Maryland. (3) Appointments are for a 4-year term, except in the first year of any committee when the terms are staggered. (4) Committee members may be reappointed for one additional 4-year term. B. Committee Meetings. (1) The committee shall determine where meetings are held and the frequency of meetings. (2) Confidential minutes shall be kept of the committee meetings and maintained in a confidential file at the Board's office. C. The Board shall review and approve all procedures established by the committee. D. The committee shall function in accordance with Health Occupations Article, §8-208(j) — (q), Annotated Code of Maryland. E. Powers and Duties of the Committee. (1) The committee may: (a) Evaluate each individual who requests to participate in the program or is referred to the program; (b) Receive and review information about program participants; and (c) Consider in each case if the participant can practice safely or an applicant qualifies for licensure or certification to practice. (2) The committee shall: (a) Prepare a written plan or agreement for each participant that establishes the requirements for supervision and monitoring; and (b) Inform each licensee, certificate holder, or applicant who requests participation in the program about: (i) The procedures to be followed; (ii) The rights and responsibilities of a participant in the program; and (iii) The possible consequences for a participant’s noncompliance with the program. (3) At the request of the Board, the committee may evaluate a nurse, certified nursing assistant, certified dialysis technician, medication technician, electrologist, direct-entry midwife, or licensed certified midwife with a substance use disorder or mental illness for readiness to return to practice. F. Annual Committee Report. The committee shall submit to the Board each year, and as requested, a report that provides: (1) The number of cases accepted, denied, or terminated with compliance or noncompliance; (2) The number of cases referred to the program that were not eligible; (3) The number of individuals referred to the program who declined admission to the program; and (4) A cost analysis of the program. #### Regulation .03 Criteria for Participation in the Program. *COMAR 10.27.13.03* A. Admission to the program is voluntary. B. Registered nurses, licensed practical nurses, direct-entry midwives, electrologists, medication technicians, advanced practice registered nurses, certified nursing assistants, certified dialysis technicians, licensed certified midwives or applicants for licensure or certification with a substance use disorder or mental illness, may be referred to the program through self-report, formal complaint, or the Board of Nursing. C. A licensee, certificate holder, or applicant requesting to participate in the program may not have: (1) Caused injury to an individual while the licensee or certificate holder was practicing as a licensee or certificate holder; or (2) Been arrested, convicted, or both, for diversion of controlled substances for sale or distribution. D. The committee and each program participant shall enter into a written agreement which lists the individual requirements for the participant’s participation in the program and the conditions which shall be met by the participant. E. If a licensee, certificate holder, or applicant fails to enter into a written agreement provided by the committee, the committee shall deny admission to the program and refer the licensee, certificate holder, or applicant to the Board for consideration of disciplinary action or denial of licensure or certification. #### Regulation .04 Noncompliance with a Written Plan or Agreement. *COMAR 10.27.13.04* A. The committee may expel a participant from the program for failure to comply with any of the conditions of the plan or agreement. B. The committee shall: (1) Report to the Board the name and license number of any participant who is expelled from the program; and (2) Transfer to the Board the records of any participant expelled from the program. C. A participant who is expelled from the program may be subject to discipline. #### Regulation .05 Board and Committee Records. *COMAR 10.27.13.05* A. All Board and committee records concerning a participant are confidential and are not subject to discovery or subpoena in any civil or criminal action or disclosure under General Provisions Article, Title 4, Annotated Code of Maryland. B. Records shall be maintained in a confidential file in the Board’s office. C. After the committee has determined that a participant no longer requires monitoring and may practice safely, all records relating to the participant’s participation in the program shall be purged and destroyed 2 years after the participant is discharged from the program. #### Regulation .06 Participants Leaving the State. *COMAR 10.27.13.06* A. A participant who moves from this State to another state where a safe practice or other rehabilitation program is in place shall be transferred to that program. B. A nurse participant who moves to a state where there is no rehabilitation program shall have the nurse’s program records transferred to the Board of Nursing in that state. C. All non-nurse participants leaving the State shall be referred to the agency responsible for regulating their license or certificate in that state and shall have the participant’s records transferred to the responsible agency in that state. #### Regulation .07 Informational Booklet. *COMAR 10.27.13.07* The committee shall publish an informational booklet for the public that describes the program. ### Chapter 14 — Nursing Staff Agencies *Repealed* **Administrative History:** Effective date: January 2, 1994 (20:26 Md. R. 2028) **Administrative History:** Chapter repealed effective December 17, 2007 (34:25 Md. R. 2211) ### Chapter 15 — Open Meetings — Attendance and Recording, Photographing, and Broadcasting of Sessions **Authority:** Health Occupations Article, §8-205; State Government Article, §§10-502h(2), 10-505, and 10-507; Annotated Code of Maryland **Administrative History:** Effective date: September 13, 1993 (20:18 Md. R. 1431) #### Regulation .01 Exclusion. *COMAR 10.27.15.01* The Board of Nursing is not subject to the provisions of COMAR 10.01.14, but shall be governed by this chapter. #### Regulation .02 Public Attendance. *COMAR 10.27.15.02* A. At any open session of the Board of Nursing, the general public may attend and observe. B. Except in instances when the Board expressly invites public testimony, questions, comments, or other forms of public participation, or when public participation is otherwise authorized by law, a member of the public attending an open session may not participate in the session. #### Regulation .03 Disruptive Conduct. *COMAR 10.27.15.03* A. Prohibition. A person attending an open session of the Board may not engage in any conduct, including visual demonstrations such as the waving of placards, signs, or banners, that disrupts the session or that interferes with the right of members of the public to attend and observe the session. B. Action to Restore Order. (1) The presiding officer may order a person who persists in conduct prohibited by §A of this regulation or who violates any other regulation concerning the conduct of the open session to be removed from the session and may request police assistance to restore order. (2) The presiding officer may recess the session while order is restored. #### Regulation .04 Recording, Photographing, and Broadcasting of Open Sessions. *COMAR 10.27.15.04* A. A member of the public, including any representative of the news media, may record discussions of the Board at an open session by means of a tape recorder or any other recording device if the device does not create an excessive noise that disturbs members of the Board or other persons attending the session. B. A member of the public, including any representative of the news media, may photograph or videotape the proceedings of the Board at an open session by means of any type of camera if the camera: (1) Is operated without excessively bright artificial light that disturbs members of the Board or other persons attending the session; and (2) Does not create an excessive noise that disturbs members of the Board or other persons attending the session. C. A representative of the news media may broadcast or televise the proceedings of the Board at an open session if the equipment used: (1) Is operated without excessively bright artificial light that disturbs members of the Board or other persons attending the session; (2) Does not create an excessive noise that disturbs members of the Board or other persons attending the session; (3) Does not interfere with a person's observation of or participation in the session; and (4) Is used openly so that it is obvious to those in attendance that the session is being recorded. #### Regulation .05 Recordings Not Part of Record. *COMAR 10.27.15.05* A recording of an open session made by a member of the public, or any transcript derived from such a recording, may not be considered a part of the record of any proceeding of the Board of Nursing. ### Chapter 16 — Registered Nurse — Workers' Compensation Medical Case Manager **Authority:** Health-General Article, §4-403; Health Occupations Article, §§8-102 and 8-205; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.10 adopted as an emergency provision effective August 2, 1999; adopted permanently effective November 15, 1999 (26:23 Md. R. 1777) **Administrative History:** Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .04 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .05A amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .06C adopted effective October 13, 2025 (52:20 Md. R. 1002) **Administrative History:** Regulation .09A amended effective July 2, 2018 (45:13 Md. R. 667) #### Regulation .01 Exclusion from Regulations. *COMAR 10.27.16.01* This chapter is not applicable to, and does not restrict or limit, a: A. Registered nurse from performing those functions which constitute the practice of registered nursing as defined by law; and B. Medical claims consultant from performing medical claims consultation as defined in this chapter. #### Regulation .02 Definitions. *COMAR 10.27.16.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Nursing. (2) “Board-approved course” means an educational offering specific to the case management of the injured worker under the Workers' Compensation Commission which meets the criteria established by the Board. (3) “Commission” means the Workers' Compensation Commission. (4) Medical Case Management. (a) “Medical case management” means any type of contact, including electronic, written, and personal, with the injured worker, for the purpose of the planning and coordination of health services appropriate to achievement of medical rehabilitation of the injured worker. (b) “Medical case management” includes but is not limited to: (i) Case assessment; (ii) Implementation and coordination of services with the injured worker, family, and health care providers; (iii) Evaluation of treatment results; (iv) Coordinating community re-entry; (v) Return to work with the employer of injury; and (vi) Referral for further vocational rehabilitation services. (5) “Medical claims consultant” means a registered nurse who consults on medical aspects of an injured worker's rehabilitation without any contact with the injured worker. (6) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (7) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (8) “RN-WCCM” means a registered nurse-workers' compensation medical case manager. #### Regulation .03 Certification Requirements. *COMAR 10.27.16.03* A. For certification as an RN-WCCM, an applicant shall: (1) Hold a current license to practice registered nursing in this State or a multistate licensure privilege to practice registered nursing; (2) Submit documentation of successful completion of a Board-approved course; (3) Submit to the Board a completed application for certification as an RN-WCCM; and (4) Pay all fees. B. The Board shall include on the RN's license the designation WCCM. C. Certification by Endorsement. An applicant from out-of-State shall meet the requirements as stated in this regulation. #### Regulation .04 Renewal of Certification. *COMAR 10.27.16.04* A. Unless renewed biennially, a certification to practice as an RN-WCCM expires at the same time as the registered nurse license. B. Before certification as an RN-WCCM expires, the RN-WCCM may renew the certification for an additional term, if the RN—WCCM: (1) Is otherwise entitled to be certified; (2) Has practiced a minimum of 2,000 hours in the past 2 years as an RN—WCCM; (3) Submits a completed application for renewal on the form the Board requires; and (4) Pays all fees. C. If the registered nurse does not meet the practice requirement stated in §B(2) of this regulation, the registered nurse shall complete a Board-approved course to be eligible for renewal of the RN-WCCM certification. #### Regulation .05 Notice to Workers' Compensation Commission. *COMAR 10.27.16.05* The Board shall: A. Notify the Commission of: (1) The status of any RN-WCCM regulated under this chapter; and (2) Any RN-WCCM who fails to renew their certification; and B. Provide the Commission quarterly reports of disciplinary actions taken against any licensee governed by this chapter. #### Regulation .06 Scope of Practice. *COMAR 10.27.16.06* A. The RN-WCCM may perform medical case management of the injured worker as defined in this chapter. B. The RN-WCCM shall comply with all: (1) Other statutes or regulations governing registered nurse practice; and (2) Laws, statutory policies, and procedures of the Commission. C. The RN-WCCM shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .07 Course Approval. *COMAR 10.27.16.07* A. Each provider shall: (1) Submit a course proposal for approval before implementation and at least every 3 years thereafter; and (2) Obtain from the Board a curriculum checklist detailing the content to be included in the course. B. All changes, additions, or deletions to the course shall be approved by the Board before implementation. #### Regulation .08 Course Requirements. *COMAR 10.27.16.08* A. Each course shall have a minimum of 16 hours of theory content. B. The curriculum shall include the following content areas: (1) An historical perspective of case management; (2) Insurance terms and types of coverage—general; (3) Federal and State insurance statutes and regulations governing workers' compensation; (4) Stakeholders—roles, responsibilities, ethical considerations, and goals; (5) Maryland Nurse Practice Act; and (6) Case management, including: (a) Assessment; (b) Planning; (c) Implementation; (d) Evaluation; (e) Written reporting; and (f) Communication. C. The course offering shall use texts from a Board-approved list. #### Regulation .09 Faculty. *COMAR 10.27.16.09* A. Qualifications. Faculty shall hold a: (1) Current license in Maryland to practice registered nursing or a multistate licensure privilege to practice registered nursing; and (2) Certification as a case manager by a certifying body recognized by the Board. B. Responsibilities. Faculty shall: (1) Plan, implement, and evaluate the course at periodic planned intervals; and (2) Develop and utilize written examinations to measure achievement of course objectives. #### Regulation .10 Unlawful Practice. *COMAR 10.27.16.10* A. Unless authorized to practice under this chapter, an individual may not use the words “registered nurse—workers' compensation medical case manager”, RN—WCCM, or any other words, letters, or symbols with the intent to represent that the individual is a registered nurse-workers' compensation medical case manager. B. An individual certified under this chapter is subject to disciplinary sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland. C. An individual may not practice medical case management for the Commission unless authorized under this chapter. ### Chapter 17 — Teletherapy **Authority:** Health Occupations Article, §§1-901, 1-902, and 8-205(a)(2)—(5), Annotated Code of Maryland **Administrative History:** Effective date: July 29, 2019 (46:15 Md. R. 655) #### Regulation .01 Scope. *COMAR 10.27.17.01* This chapter applies to all certified registered nurse practitioners/psychiatric mental health (CRNP/PMH) and psychiatric mental health/advanced practice registered nurses (PMH/APRN) in Maryland, with a specialty certification in psychiatric mental health, who will be providing behavioral health services using teletherapy. #### Regulation .02 Definitions. *COMAR 10.27.17.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Certified registered nurse practitioner/psychiatric mental health (CRNP/PMH)” means a certified registered nurse practitioner who: (a) Is certified by the Board as a certified registered nurse practitioner in the practice of psychiatric mental health; and (b) Autonomously and independently engages in activities authorized by this chapter and in accordance with COMAR 10.27.07. (2) “Psychiatric mental health/advanced practice registered nurse (PMH/APRN)” means an advanced practice registered nurse who: (a) Is certified by the Board as a clinical nurse specialist in the practice of psychiatric mental health; and (b) Autonomously and independently engages in activities authorized by this chapter and in accordance with COMAR 10.27.12. (3) “Synchronous” means simultaneous or quick enough to allow two or more individuals to interact. (4) Teletherapy. (a) “Teletherapy” means the delivery of behavioral health services by a CRNP/PMH or a PMH/APRN at a location other than the location of the client through the use of synchronous interactive audio, video, audio-visual, or other telecommunications or electronic technology. (b) “Teletherapy” does not include: (i) An audio-only telephone conversation between the CRNP/PMH or PMH/APRN and a client; (ii) An electronic mail message between a CRNP/PMH or PMH/ APRN and a client; or (iii) A facsimile transmission between a CRNP/PMH or PMH/APRN and a client. #### Regulation .03 Licensure. *COMAR 10.27.17.03* An individual shall be licensed as a registered nurse in Maryland, or have an active multistate licensure privilege to practice as a registered nurse in Maryland, and be certified by the Board as a CRNP/PMH or PMH/APRN in order to provide teletherapy services in Maryland if either the client or the CRNP/PMH or PMH/APRN is physically located in Maryland. #### Regulation .04 Teletherapy. *COMAR 10.27.17.04* A. In order to provide teletherapy services to a client, a CRNP/PMH or PMH/APRN shall have: (1) Established a client-therapist relationship; (2) Performed a mental status assessment; (3) Established a diagnosis; (4) Developed a treatment plan; and (5) Obtained an informed consent from the client to provide teletherapy. B. Before providing teletherapy services, the CRNP/PMH or PMH/APRN shall develop a procedure to: (1) Verify the identity of the client receiving teletherapy services; (2) Ensure that all medical records are protected from unauthorized access through encryption or other means; (3) Ensure that the CRNP/PMH or PMH/APRN provides a secure and private teletherapy connection and complies with federal and state privacy laws; (4) Notify a client in the event of a data breach in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and the Maryland Confidentiality of Medical Records Act; and (5) Establish safety protocols to be used in the case of an emergency. C. At the outset of each teletherapy session, the CRNP/PMH or PMH/APRN shall: (1) Identify all individuals present at each location and confirm that they are permitted to hear or access personal health information; (2) Obtain or confirm an alternative method of contacting the client in case of a technological failure; and (3) Determine whether the client is in Maryland. #### Regulation .05 Standards of Practice. *COMAR 10.27.17.05* A. A CRNP/PMH or PMH/APRN providing teletherapy services shall be held to the same standards of practice and documentation as those applicable in in-person health care settings. B. A CRNP/PMH or PMH/APRN may not treat a patient or prescribe medication based solely on an online questionnaire. #### Regulation .06 Discipline. *COMAR 10.27.17.06* A. The Board shall use the same standards in evaluating and investigating a complaint and disciplining a CRNP/PMH or PMH/APRN who provides teletherapy as it would use for a CRNP/PMH or PMH/APRN who is not. B. A CRNP/PMH or PMH/APRN who provides teletherapy services and fails to comply with this chapter may be subject to discipline under Health Occupations Article, §8-316, Annotated Code of Maryland. ### Chapter 18 — Monetary Penalties **Authority:** Health Occupations Article, §§8-316, 8-6C-20, and 8–6D–10, Annotated Code of Maryland **Administrative History:** Effective date: April 10, 1995 (22:7 Md. R. 536) **Administrative History:** Regulation .01 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .02B amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03A amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .04A, H amended effective July 2, 2018 (45:13 Md. R. 667) #### Regulation .01 Scope. *COMAR 10.27.18.01* This chapter establishes standards for the imposition of monetary penalties not exceeding $5,000 against a registered nurse, licensed practical nurse, direct-entry midwife, licensed certified midwife, or advanced practice registered nurse if the Board finds that there are grounds to take action under Health Occupations Article, §8-316, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.27.18.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Nursing. (2) “Licensee” means, unless the context requires otherwise, a: (a) Registered nurse, a licensed practical nurse, or an advanced practice registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland; (b) A licensed direct-entry midwife as defined in Health Occupations Article, §8-6C-01, Annotated Code of Maryland; and (c) A licensed certified midwife as defined in Health Occupations Article, §8-6D-01, Annotated Code of Maryland. (3) “Penalty” means monetary fine. #### Regulation .03 Imposition of Penalty Generally. *COMAR 10.27.18.03* A. The Board may impose a penalty against a licensee if the Board finds that there are grounds to take action against the licensee pursuant to Health Occupations Article, §8-316, Annotated Code of Maryland. B. The penalty in §A of this regulation may be imposed instead of or in addition to suspending or revoking the license, reprimanding the licensee, or placing the licensee on probation. #### Regulation .04 Imposition of Penalties on Licensees. *COMAR 10.27.18.04* A. A penalty of not less than $100 or more than $1,000 may be imposed by the Board on a licensee if found guilty of any of the following: (1) Filing a false report or record of an individual under the licensee's care; (2) Giving any false or misleading information about a material matter in an employment application; (3) Failing to file or record any health record that is required by law; (4) Obstructing the filing or recording of any health record as required by law; (5) Inducing another individual to fail to file or record any health record as required by law; (6) Violating any provision of Health Occupations Article, §8-316, Annotated Code of Maryland; (7) Submitting a false statement to collect a fee; (8) Being professionally, physically, or mentally incompetent; (9) Providing professional services while: (a) Under the influence of alcohol, or (b) Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; (10) Knowingly failing to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (11) Refusing, withholding, denying, or discriminating against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render care because the individual is HIV positive; (12) Except in an emergency life-threatening situation where it is not feasible or practicable, failing to comply with the guidelines on universal precautions which are incorporated by reference in COMAR 10.06.01.02B(13); (13) Being in independent practice and failing to display the notice required under Health Occupations Article, §8-506, Annotated Code of Maryland; (14) Failing to begin to fulfill a public service requirement within 1 year of when the assignment is to begin that was a condition of the applicant or licensee receiving State or federal loans or scholarships for the applicant's or licensee's nursing education; or (15) Being expelled from the Safe Practice Program established pursuant to Health Occupations Article, §8-208, Annotated Code of Maryland, for failure to comply with the conditions of the program. B. Violation of Probation. A penalty of $100 per violation may be imposed by the Board on a licensee who fails to comply with the conditions of probation. C. A penalty of not less than $1,000 or more than $5,000 may be imposed by the Board on a licensee found guilty of any of the following: (1) Fraudulently or deceptively obtaining or attempting to obtain a license for the applicant or for another; (2) Fraudulently or deceptively using a license; (3) Being disciplined by a licensing or disciplinary authority of any other state or country or convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes; (4) Being convicted of or pleading guilty or nolo contendere to a felony or to a crime involving moral turpitude whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. D. The Board may impose a penalty of not less than $500 or more than $5,000 upon a licensee found guilty of knowingly doing any act that has been determined by the Board, in the Board's regulations, to exceed the scope of practice authorized to the individual under this title when the violation is: (1) Determined to be willful or actual harm results, or both, the penalty may range from $500 to $5,000; (2) Determined to be willful and there is potential harm to the public, the penalty may range from $500 to $2,000; (3) Determined to be negligent or actual harm results, or both, the penalty may range from $500 to $5,000; (4) Determined to be negligent and there is potential harm to the public, the penalty may range from $500 to $2,000; and (5) A repeat offense, the penalty may be double the amount for the category of offense described in this section, not to exceed $5,000. E. A penalty of up to $1,000 per violation may be imposed by the Board on a licensee who knowingly abuses a patient without causing patient harm. F. A penalty of up to $5,000 per violation may be imposed by the Board on a licensee who knowingly abuses a patient and causes patient harm. G. Fines other than those stated above may be imposed at the discretion of the Board. H. Failure to Renew. (1) The Board may impose the following penalties on a licensee for failure to renew licensure: (a) Not less than $150 per month for practicing on a non-renewed license for a period of up to 1 year; or (b) Amount to be determined by the Board for practicing nursing with a license that was non-renewed for a period of more than 1 year. (2) A penalty of up to $5,000 may be imposed by the Board on a director of nursing found guilty of employing nurses with lapsed licenses on two or more occasions within 1 year. #### Regulation .05 Payment of Monetary Penalties. *COMAR 10.27.18.05* A. The licensee shall pay all fines by cashier's check or money order made payable to the Board and delivered personally or by certified mail to the Board within 60 days of the date of the order. B. The Board shall pay all monies collected by the Board pursuant to these regulations into the general fund of the State. ### Chapter 19 — Code of Ethics **Authority:** Health Occupations Article, §§8-205 and 8-316(a)(25), Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1996 (23:13 Md. R. 944) **Administrative History:** Regulations .01—.04 repealed and new Regulations .01—.03 adopted effective September 16, 2002 (29:18 Md. R. 1443) **Administrative History:** Regulation .01B amended effective December 11, 2014 (41:24 Md. R. 1428); July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .02 amended effective December 11, 2014 (41:24 Md. R. 1428) **Administrative History:** Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667) #### Regulation .01 Definitions. *COMAR 10.27.19.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abandonment. (a) “Abandonment” means: (i) Termination by a nurse of a client assignment which had been accepted by the nurse, without reasonable notification to the immediate supervisor to allow for the continuation of the client’s care; (ii) In the case of a natural disaster or a federal, State, county, or city declaration of an emergency, refusal by a nurse of an assignment, mandatory overtime, or both; or (iii) In the case of a private duty assignment or hospice, if the nurse is the sole provider of care, failure to report for assigned duty or leaving the client unattended at the end of the assigned shift without prior notification to the nursing supervisor, the cognitive capable adult client, or the client’s designated representative. (b) “Abandonment” does not include the declining by a nurse of employer-stipulated mandatory overtime. (2) “Accepting a client assignment” means a nurse has arrived on duty and assumed responsibility for client care based on the nurse’s reasonable and prudent professional judgment and the standards of nursing practice. (3) “Board” means the Board of Nursing. (4) “Client” means a patient, resident, or recipient of care. (5) “Electronic devices” means, but is not limited to, any of the following: (a) Telephones with recording and picture-taking ability; (b) Digital cameras or any other device that can record pictures and data; (c) Facsimile machines, photocopiers, and scanners for copying; and (d) Recording devices. (6) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (7) “Nurse” means a registered nurse, licensed practical nurse, or advanced practice registered nurse as defined in Health Occupations Article, §8-101, Annotated Code of Maryland. (8) “Social media” means any form of electronic communication, including, but not limited to, communication by use of websites for social networking and blogging through which users create online communities to share information, ideas, personal messages, and other content such as videos. #### Regulation .02 Ethical Responsibilities. *COMAR 10.27.19.02* A. A nurse shall: (1) Provide services with respect for human dignity and the uniqueness of a client unrestricted by consideration of social or economic status, religious affiliation, personal attributes, or the nature of health problems; (2) Safeguard a client's right to privacy by maintaining confidentiality of information; (3) Act to safeguard a client and the public if health care and safety are affected by the incompetent, unethical, or illegal practice of any person; (4) Promptly report a breach of confidentiality or privacy; (5) Assume responsibility and accountability for individual nursing judgments and actions; (6) Maintain competence in nursing; (7) Exercise informed judgment and use individual competence and qualifications as criteria in seeking consultation, accepting responsibilities, and delegating nursing activities to others; and (8) Inform the Board regarding unethical conduct by another licensed nurse. B. A nurse may not, when acting in the capacity or identity of a licensed nurse: (1) Knowingly participate in or condone dishonesty, fraud, deceit, or misrepresentation; (2) Engage or participate in an action that violates or diminishes the civil or legal rights of a client; (3) Perform new techniques and procedures without adequate education and practice; (4) Assume duties and responsibilities in the practice of nursing without adequate preparation or without maintaining competency; (5) Practice nursing if unfit to perform procedures or make decisions because of physical or mental impairment, including, but not limited to, the effects of prescription drugs; (6) If engaged in research, coerce or pressure a subject to participate or continue to participate in the research; or (7) Abandon a client. C. A nurse may not engage in behavior that dishonors the profession whether or not acting in the capacity or identity of a licensed nurse, including, but not limited to: (1) Verbal abuse, including use of racial or ethnic slurs, directed toward a coworker, employer, Board staff member, client, or client’s family member; (2) Physically abusing, threatening, or intimidating a coworker, employer, Board staff member, client, or client’s family member; (3) Deceiving, defrauding, or stealing from a coworker, employer, client, or client’s family member; (4) Diverting any medication or providing false or misleading information to an authorized prescriber or a pharmacist to obtain or attempt to obtain any medication; (5) Knowingly employing another person to practice or engage in or attempt to practice or engage in an occupation or profession licensed under this title if the employee is not licensed to do so under Health Occupations Article, Title 8, Annotated Code of Maryland; (6) Performing acts beyond the authorized scope of the level of nursing practice for which the individual is licensed; (7) Obtaining or copying any part of a client’s health record for purposes other than: (a) Providing health care to the client; (b) Conducting quality improvement activities; (c) Complying with legal requirements such as a subpoena; or (d) Allowing a nursing student to use records for educational purposes if client identification has been redacted or disguised; (8) Using, possessing, supplying, administering, or attempting to use, possess, supply, or administer prescription drugs or controlled dangerous substances without valid medical indication; (9) Reporting for employment under the influence of alcohol or a controlled dangerous substance or submitting a pre-employment sample that is positive for alcohol or a controlled dangerous substance without having provided evidence of valid prescriptions for all controlled dangerous substances in the sample; (10) Reporting for employment under the influence of an illicit drug or submitting a pre-employment sample that is positive for an illicit drug; (11) Using the power, influence, or knowledge, inherent in or obtained during the nurse-patient relationship, for the nurse’s personal gratification or benefit; (12) Engaging in unprofessional or immoral conduct; (13) Misrepresenting or concealing a material fact in obtaining a license, renewing a license, or reinstating a license; or (14) Committing an act of moral turpitude, dishonesty, or corruption when the act directly or indirectly affects the health, welfare, or safety of the citizens of this State, and, if the act constitutes a crime, conviction thereof in a criminal proceeding is not a condition precedent to disciplinary action. D. A nurse may not engage in sexual misconduct. Sexual misconduct includes, but is not limited to: (1) Sexual behavior with a client in the context of a professional evaluation, treatment, procedure, or service to the client, regardless of the setting in which the professional service is rendered; (2) Sexual behavior with a client under the pretext of diagnostic or therapeutic intent or benefit; (3) Solicitation of a sexual relationship, whether consensual or nonconsensual, with a client; (4) Sexual advances toward, or the request of sexual favors from, a coworker, student, employer, client, or client’s family member; (5) Discussion of nontherapeutic sexual matters while treating a client; (6) Taking photographs of a client for a sexual purpose; (7) Sexual harassment of a coworker, student, employer, client, or client’s family member; (8) Sexual contact with an incompetent or unconscious client; (9) Intentionally exposing any of the nurse's sexual body parts; and (10) Intentionally exposing any of the client’s sexual body parts for a nontherapeutic purpose. E. Electronic devices, including but not limited to telephones, may not be used to record medical records and take pictures or videos of clients without written client authorization. F. A nurse: (1) May not make use of electronic devices and social media to transmit or place any client information online; and (2) Shall adhere to the following principles for the use of electronic devices and social media: (a) Every nurse has an obligation to understand the nature, benefits, and consequences of the use of electronic devices and participating in social media networking; (b) Nurses are bound to observe ethically prescribed client-nurse boundaries online as in any other setting; (c) Client information shall be maintained in separate encrypted and secured files on personal computers and online; (d) A nurse has an obligation to report any electronically generated material that could harm a client’s privacy rights; and (e) The standards of professionalism are the same when using electronic devices and social media as in any other circumstance. #### Regulation .03 Penalties. *COMAR 10.27.19.03* Violation of this chapter may result in the Board taking disciplinary action against a nurse pursuant to Health Occupations Article, §8-316, Annotated Code of Maryland. ### Chapter 20 — Management of Infusion Therapy by the Registered Nurse and the Licensed Practical Nurse **Authority:** Health-General Article, §4-403; Health Occupations Article, §8-205; Annotated Code of Maryland **Administrative History:** Effective date: October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulations .01—.04 repealed and new Regulations .01—.06 adopted effective November 15, 1999 (26:23 Md. R. 1777) **Administrative History:** Regulation .02B amended effective October 27, 2003 (30:21 Md. R. 1529); July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .03 amended effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .04 amended effective July 2, 2018 (45:13 Md. R. 667); October 13, 2025 (52:10 Md. R. 1002) **Administrative History:** Regulation .05 amended effective October 27, 2003 (30:21 Md. R. 1529) **Administrative History:** Regulation .06B amended effective October 27, 2003 (30:21 Md. R. 1529) #### Regulation .01 Exclusion from Regulations. *COMAR 10.27.20.01* This chapter is not applicable to, and does not restrict or limit, other health care practitioners who are authorized to perform these duties under their respective laws. #### Regulation .02 Definitions. *COMAR 10.27.20.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administer” means to hang or give subsequent fluids and medications. (2) “Antineoplastic” means: (a) Chemical or biologic agents that have a toxic effect on the disease-causing agent or modify the host environment; or (b) Drugs that are capable of destroying invading organisms or malignant tumor cells. (3) “Arterial catheter” means a catheter or needle inserted into an artery. (4) “Assign” means to designate another licensee to be responsible and accountable to perform nursing acts that are within the licensee's scope of practice, knowledge, judgment, and skill. (5) “Central venous catheter (CVC)” means a catheter whose tip is located in a central vessel. (6) “Chronic dialysis client” means a client with end stage renal disease who is receiving routine dialysis treatments in an outpatient facility. (7) “Clinical competence” means the demonstrated ability to perform the identified IV tasks consistent with the standards established by the INS, ONS, or other bodies approved by the Board. (8) “Comprehensive assessment” means a nursing assessment that includes: (a) The specific individual patient's clinical status; (b) Medical treatment regime; and (c) Complexity of the infusion therapy treatment regime including: (i) The purpose and effects of the specific infusate or medication; (ii) Skills to access and de-access the infusion catheter access device; and (iii) The potential harm to the patient should an error occur. (9) Direct Supervision. (a) “Direct supervision” means oversight exercised by a registered nurse who is present on the unit of care during the infusion therapy process. (b) “Direct supervision” includes the actions of: (i) Observation; (ii) Assessment; (iii) Evaluation; and (iv) Direction. (10) “First dose” has the meaning defined by the facility's policies and procedures. (11) “Hypodermoclysis” means the infusion of fluids into subcutaneous tissue for hydration. (12) Implanted Port. (a) “Implanted port” means a reservoir surgically placed under the skin and attached to a catheter which is placed in a vessel, body cavity, or organ. (b) “Implanted port” is often referred to as a medi-port, port-a-cath, infuse-a-port, infusion port, or a subcutaneous port. (13) “Implanted pump” means a catheter surgically placed into a vessel, body cavity, or body space, and attached to a reservoir placed under the skin, that contains a pumping mechanism for continuous medication administration. (14) “Infusion therapy” means the initiation and administration of medication, fluids, and nutrients via an intravenous access device. (15) “Initiate” means to hang and administer the first dose of medications or fluids. (16) “INS” means Infusion Nurses Society. (17) “Intraventricular reservoir” means a catheter threaded through the dura into a ventricle of the brain. (18) “Licensee” means a registered nurse or licensed practical nurse. (19) “LPN” means an individual who: (a) Is licensed by the Board to practice licensed practical nursing; or (b) Has a multistate licensure privilege to practice licensed practical nursing. (20) “Midclavicular catheter” means a peripherally inserted catheter with the distal tip located between the axilla and the vena cava. (21) “Midline catheter” means a peripherally inserted catheter with the tip terminating below the axilla. (22) “Multi-lumen catheter” means a venous access device that has more than one lumen. (23) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (24) “Non-tunneled catheter” means a percutaneously placed catheter inserted into the vein. (25) “ONS” means Oncology Nursing Society. (26) “On-site supervision” means oversight exercised by a supervising registered nurse who is: (a) Present in the facility; and (b) Quickly and easily available to the patient and the assigned nurse during the course of infusion therapy. (27) “Peripheral catheter” means a catheter or needle inserted into a superficial vein with the tip residing outside of the central venous system. (28) “Peripheral veins” means those veins in the superficial aspects of the body excluding the external jugular vein. (29) “Peripherally inserted central catheter (PICC)” means a catheter, inserted with or without a guide wire, whose tip is located in the vena cava. (30) “PPN” means partial parenteral nutrition. (31) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (32) “Specialized catheter” means an epidural, intrathecal, intrapleural, or peripheral nerve catheter. (33) “Subcutaneous infusion of medication” means a continuous or intermittent infusion of medication by an indwelling needle or catheter inserted into subcutaneous tissue. (34) “TPN” means total parenteral nutrition administered into the central venous system. (35) “Tunneled catheter” means a CVC designed to have a portion of the catheter lie in a subcutaneous passage before exiting the body. (36) “Nonsurgically placed” means a catheter placed percutaneously. #### Regulation .03 Education. *COMAR 10.27.20.03* To perform infusion therapy, the licensee shall: A. Complete an infusion therapy program of study which contains didactic content and a clinical practicum consistent with the standards of practice established by the INS or other bodies approved by the Board that includes but is not limited to: (1) Infusion access devices; (2) Selected infusates, blood, and blood components; (3) Nursing assessment and monitoring skills required for the infusion therapy acts to be performed; (4) Management of complications related to the infusion therapy and access devices; and (5) Delivery devices; B. Have documented evidence of clinical competency before independently: (1) Inserting infusion devices; or (2) Managing the care of patients receiving infusion therapy; C. Perform the infusion therapy acts on a frequent routine predictable basis in order to retain practice proficiency; D. Be evaluated for continued clinical competency at planned periodic time intervals; and E. Obtain additional education on nursing assessment and monitoring when the patient population changes. #### Regulation .04 Infusion Therapy Acts — General. *COMAR 10.27.20.04* A. The licensee shall comply with the employer's written policies and procedures which are in compliance with this chapter regarding infusion therapy. B. The licensee shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .05 Infusion Therapy Acts — LPN. *COMAR 10.27.20.05* A. The LPN may perform the following infusion therapy acts for peripheral and subcutaneous infusions when there is an RN on site or available by telephone: (1) Calculate and adjust flow rate including pumps; (2) Observe and report on: (a) Insertion site; and (b) Objective and subjective signs of adverse reactions to infusion therapy; (3) Change the dressing on the insertion site; (4) Change the administration set; (5) Insert subcutaneous needle or catheter to: (a) Rotate sites for an existing infusion; and (b) Administer a medication which is routine for the patient; (6) Insert a peripheral IV needle or catheter (excluding midline) to: (a) Withdraw a blood specimen; or (b) Initiate IV fluids; (7) Remove a peripheral and subcutaneous IV needle or catheter; (8) Flush a peripheral and midline IV device; (9) Convert an existing continuous infusion to an intermittent infusion; (10) Convert an intermittent infusion to a continuous infusion; (11) Change injection cap; (12) Insert device and initiate hypodermoclysis and add replacement solutions; and (13) Administer medication via a peripheral IV line (including midline) using: (a) Pharmacy-prepared medication; and (b) PPN solutions; and (14) Add medications to an intravenous solution. B. The LPN may perform the following acts for midclavicular, CVC, PICC, and implanted ports: (1) Calculate and adjust flow rate including a pump; (2) Observe and report on: (a) The insertion site; and (b) Objective and subjective signs of adverse reactions to infusion therapy; (3) Change the dressing on the insertion site; (4) Flush a midclavicular, PICC, CVC, and an accessed implanted port; (5) Change injection cap; (6) Change administration sets; (7) Convert an existing continuous infusion to an intermittent infusion; and (8) Convert an intermittent infusion to a continuous infusion. C. The LPN may perform the following additional acts under the direct supervision of the RN following a comprehensive patient assessment: (1) Administer TPN via PICC, implanted ports, or CVC; (2) Administer medications by midclavicular, PICC, CVC, and implanted ports by hanging pharmacy prepared solutions; (3) Add medication to a solution administered via PICC, midclavicular CVC, and implanted ports; (4) Observe, monitor, and report on the patient: (a) With specialized catheters; and (b) During a blood transfusion; (5) Initiate and administer blood and blood components; (6) Draw blood specimens via midline, PICC, CVC, and implanted ports; (7) Access and de-access implanted ports; and (8) Initiate the first dose of a medication after it has been reviewed and evaluated for potential risk by the RN. D. On completion of a second specialized educational program in infusion therapy, containing didactic content and a clinical practicum, consistent with the standards of ONS or other bodies approved by the Board and with documented evidence of clinical competency, the LPN may administer standardized doses of non-vesicant chemotherapeutic agents and antiviral agents to an existing infusion in accord with the facility's written protocol or practice guidelines. The LPN shall perform these additional procedures under the direct supervision of the RN following a comprehensive patient assessment. E. The LPN may perform additional infusion therapy acts in a licensed outpatient dialysis facility serving the chronic dialysis client when: (1) The requirements of Regulations .03 and .04 of this chapter and §§A—C of this regulation have been met; (2) The outpatient dialysis unit RN skilled in chronic dialysis has taught a didactic and clinical practicum for the LPN which includes but is not limited to: (a) Pharmacological interventions specific to: (i) Physiological alterations and effects of chronic renal failure; (ii) Indication, dosage, side effects, and contraindications of each drug intervention; and (iii) Special considerations of each drug intervention specific to the chronic renal failure client; and (b) Route of medication administration and access delivery systems; (3) The outpatient dialysis RN documents evidence of the LPN's clinical competency of the additional activities under §F of this regulation. F. The LPN may perform the following additional infusion acts, that may include the flushing of catheters, in a licensed outpatient dialysis facility serving the chronic dialysis client under the direct supervision of the RN skilled in chronic dialysis: (1) Venipuncture for the purpose of hemodialysis; (2) Initiation of and discontinuation from dialysis utilizing the various accesses, including: (a) Subclavian catheters; (b) Internal jugular catheters; (c) Femoral vein catheters; (d) Arterial catheters; (e) Fistulas; and (f) Grafts; (3) Withdrawal of blood and heparinized saline from the various accesses for the purpose of removing the heparin and establishing patency; (4) Withdrawal of blood from access for the purpose of obtaining blood for a laboratory specimen; (5) Administration of IV medications and solutions during hemodialysis; (6) Performance of dressing changes to various access device sites; and (7) Administration of the following medications by IV “push” per physician order and nationally recognized standards of care: (a) Anticoagulant agents; (b) Saline; (c) Erythropoeitic agents; (d) Vitamin D products; (e) Iron preparation agents; and (f) Anti-emetic agents. G. The LPN may not perform the following acts: (1) Administer medication via IV “push”, except as set forth in §F(7) of this regulation; (2) Insert a midline catheter; (3) De-clot the catheter; (4) Repair a catheter; (5) Insert and remove PICC, midline catheters, and midclavicular catheters; (6) Manage specialized catheters for analgesia; and (7) Remove nonsurgically placed central and arterial catheters. #### Regulation .06 Infusion Therapy Acts — RN. *COMAR 10.27.20.06* A. In addition to all previously identified procedures in Regulations .04 and .05A—C of this chapter, the RN may perform the following procedures: (1) Administer medication via IV “push”; (2) Initiate subcutaneous infusion of medication; and (3) Provide care and manage arterial catheters and arterial ports by: (a) Changing IV administration set; (b) Flushing or aspirating; (c) Changing dressing; (d) Obtaining blood specimens; (e) Accessing and de-accessing; and (f) Changing injection cap. B. The RN, upon completion of a second specialized educational program in infusion therapy which includes didactic content and a clinical practicum consistent with the standards established by the ONS or other bodies approved by the Board and with documented evidence of clinical competency, may perform the following additional infusion therapy activities: (1) Administer antineoplastic agents; (2) Aspirate fluid from an intraventricular reservoir; (3) Administer fluids and medications via an intraventricular reservoir; (4) Manage implantable pumps by programming and filling with fluids and medications; (5) Insert, repair, and remove PICC and midclavicular catheters; (6) Insert and remove midline catheters; (7) Manage specialized catheters for analgesia; (8) Remove nonsurgically placed central and arterial catheters; (9) Administer pharmacological agents to de-clot or restore blood return; and (10) Repair a catheter. C. The RN may not perform the following acts: (1) Administer the initial dose of any medication by intrathecal, epidural, intrapleural, or peripheral nerve catheter; or (2) Remove any tunneled catheter. ### Chapter 21 — Registered Nurse — Forensic Nurse Examiner **Authority:** Health-General Article, §4-403; Health Occupations Article, §§8-205 and 8-312; Annotated Code of Maryland **Administrative History:** Effective date: December 13, 1999 (26:25 Md. R. 1898) **Administrative History:** Regulations .01—.08 repealed and new Regulations .01—.08 adopted effective April 28, 2003 (30:8 Md. R. 542) **Administrative History:** Regulation .05 amended effective September 25, 2006 (33:19 Md. R. 1561) **Administrative History:** Regulation .07D adopted effective September 25, 2006 (33:19 Md. R. 1561) **Administrative History:** Chapter revised effective March 19, 2012 (39:5 Md. R. 383) **Administrative History:** Regulation .02B amended effective February 27, 2017 (44:4 Md. R. 254); September 10, 2018 (45:18 Md. R. 834) **Administrative History:** Regulation .03 amended effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .03B amended effective September 10, 2018 (45:18 Md. R. 834) **Administrative History:** Regulation .04A, C amended effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .04E adopted effective October 13, 2025 (52:20 Md. R. 1002) **Administrative History:** Regulation .05 amended effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .07 amended effective January 18, 2016 (43:1 Md. R. 13); February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .08A amended effective September 10, 2018 (45:18 Md. R. 834) #### Regulation .01 Exclusion from Regulations. *COMAR 10.27.21.01* This chapter is not applicable to and does not restrict or limit: A. Other health care practitioners who are authorized to perform these duties under the Maryland Health Occupations Article; or B. A licensed practical or registered nurse from acting as a chaperone during a forensic examination. #### Regulation .02 Definitions. *COMAR 10.27.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Alternate light source (ALS)” means equipment that produces visible and invisible light at various wave lengths to enhance the visualization of evidence. (2) “Board” means the Board of Nursing. (3) “Chain of custody” means a written list identifying, without interruption or lapse, every individual having control or possession of specified items or evidence. (4) “Chaperone” means an individual who does not perform any part of the forensic examination but is present during the course of that examination. (5) “Clinical preceptor” means an RN-FNE educator or physician who has credentials and experience in forensic examinations. (6) “Education” means: (a) Giving presentations, including mentored clinical presentations; (b) Attending conferences or seminars; (c) Completing accredited professional computerized or periodical learning modules; and (d) Participating in the facility evaluation or audit process. (7) “FNE program” means a facility authorized by the Maryland Department of Health to provide forensic nursing services. (8) “Forensic evidentiary examination” means an examination for the purpose of gathering, labeling, preserving, and handling evidence that includes, but is not limited to: (a) Photographic and written descriptive documentation of the findings; (b) A general health and assault history interview; and (c) A physical assessment which may include, but is not limited to: (i) Skin surface examination; (ii) Oral examination; (iii) Genital examination; (iv) Anal examination; and (v) Speculum vaginal examination. (9) “Gynecological Urological teaching associate (GUTA)” means an adult who is trained to teach techniques for performing gender-specific physical examination to health care trainees, using self as a demonstration and practice model with emphasis on teaching from the patient perspective. (10) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (11) “Peer review” means a process by which an RN-FNE’s clinical examination and documentation is reviewed by one or more peers who are authorized to perform the duties of an RN-FNE. (12) “Physician” means an individual licensed to practice medicine in this State. (13) “Practice guideline” means a written documentation that details the standards of care and practice protocols the facility has established to guide the practice of the RN-FNE. (14) “Program coordinator” means an RN-FNE designated by the facility to manage and oversee the FNE program. (15) “Proper authority” means a representative of law enforcement, adult or child protective services, or the jurisdictional authority for a minor or mentally incapacitated individual. (16) “Refresher course” means a curriculum that: (a) Includes didactic and clinical education; and (b) Meets the practice requirements for reinstatement of certification as an RN-FNE. (17) “Registered nurse” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (18) “RN-FNE” means a registered nurse forensic nurse examiner certified by the Board. (19) “RN-FNE Educator” means an individual who: (a) Has a current: (i) License to practice as a registered nurse in Maryland; (ii) Multistate licensure privilege to practice registered nursing under the Nurse Licensure Compact; or (iii) Certification to practice as an advanced practice registered nurse in Maryland; and (b) Is certified under this chapter as a: (i) Registered Nurse Forensic Examiner — Adult (RN-FNE-A); (ii) Registered Nurse Forensic Examiner — Pediatric (RN-FNE-P); or (iii) Registered Nurse Forensic Examiner — Adult and Pediatric (RN-FNE-AP); and (c) Is qualified to teach the theoretical and clinical portions of the RN-FNE training program. (20) “RN-FNE-A” means a registered nurse certified by the Board to practice as a forensic nurse examiner with respect to forensic examinations performed on adults and individuals 13 years old or older. (21) “RN-FNE-P” means a forensic nurse examiner-pediatric who is certified by the Board to practice as a forensic nurse examiner with respect to examinations of children who are younger than 13 years old. (22) “RN-FNE-AP” means a registered nurse certified by the Board to practice as a forensic nurse examiner with respect to examinations of individuals of all ages. (23) “SAFE” means a registered nurse who was certified by the Board before December 13, 1999, as a sexual assault forensic examiner under this chapter. (24) “SANE” means a registered nurse who has successfully completed a program which meets the Sexual Assault Nurse Examiner Standards of Practice established by the International Association of Forensic Nurses. (25) “SANE-A” means a forensic nurse examiner certified by the International Association of Forensic Nurses (IAFN) to perform a forensic evidentiary examination on adults and individuals 13 years old or older. (26) “SANE-P” means a forensic nurse examiner certified by the IAFN to perform a forensic evidentiary examination on children who are younger than 13 years of age. (27) "Simulation” means the utilization of an adult anatomically correct manikin or a GUTA in the performance of a forensic evidentiary examination. (28) “Training program” means the instructional process utilizing the standardized curriculum approved by the Board. #### Regulation .03 Authorization to Practice. *COMAR 10.27.21.03* A. An individual may be certified as: (1) A registered nurse forensic nurse examiner-adult (RN-FNE-A); (2) A registered nurse forensic nurse examiner-pediatric (RN-FNE-P); or (3) A registered nurse forensic nurse examiner-adult/pediatric (RN-FNE-AP). B. An applicant applying for certification to practice as an RN-FNE-A, RN-FNE-P or RN-FNE-AP shall: (1) Either: (a) Hold a current license to practice as a registered nurse in Maryland; or (b) Have a multistate licensure privilege to practice registered nursing; (2) Have at least 18 months of continuous clinical experience as a registered nurse; (3) Complete a training program that includes a standardized curriculum approved by the Board and designed for the RN-FNE-A; (4) Complete in full the application for certification in the category selected; and (5) Pay all fees established by the Board in COMAR 10.27.01.02. C. In addition to the requirements listed in §B of this regulation, an applicant applying for certification as an RN-FNE-P or RN-FNE-AP shall complete a training program that includes the following standardized curricula approved by the Board: (1) The standardized curriculum designed for the RN-FNE-A; and (2) The standardized curriculum designed for the RN-FNE-P. D. A registered nurse who has been certified by the Board as a SAFE on or after December 13, 1999 may be certified to practice as an RN-FNE-A, RN-FNE-P, or RN-FNE-AP if the individual: (1) Submits a form required by the Board attesting that the individual has: (a) Served in the role of SAFE for 200 hours in the previous 12 months; (b) Obtained a total of 8 education clock hours in forensic science or forensic nursing in the previous 12 months; (c) Completed three sexual assault evidentiary examinations in the previous 12 months with respect to: (i) Adults and individuals 13 years old or older if applying for RN-FNE-A; (ii) Children who are younger than 13 years old if applying for RN-FNE-P; or (iii) Each category, if applying for RN-FNE-AP, for a total of six examinations; and (2) Complies with all other requirements of this chapter. E. The Board shall: (1) Maintain an up-to-date list of all RNs certified to practice as RN-FNEs in the State; and (2) Include on the RN's license an indication that the licensee is certified to practice as an RN-FNE, and a designation of the RN-FNE's area of specialization. #### Regulation .04 Scope and Standards of Practice. *COMAR 10.27.21.04* A. An RN-FNE may perform the following tasks and functions with respect to the age group for which the RN-FNE is certified under Regulation .03 of this chapter: (1) Perform forensic evidentiary examinations on victims and alleged perpetrators in connection with physical, sexual, or domestic assaults, whether chronic or acute; (2) Before the forensic evidentiary examination, obtain consent from the individual being examined, from the parent or guardian of a minor individual, or from the proper authority for photographing and evidence collection; (3) Prepare and document the assault history interview; (4) Perform the forensic evidentiary physical assessment, which may include use of an ALS; (5) Complete the physical evidence kit provided by law enforcement; (6) Gather, preserve, handle, document, and label forensic evidence, including but not limited to: (a) Labeling evidence collection containers with the patient's identifying data per local jurisdiction requirements; (b) Placing evidence in the evidence collection container and sealing the container; (c) Signing the evidence collection container as the collector of the evidence; (d) Taking photographs; and (e) Obtaining swabs, smears, and hair and body fluid samples; (7) Maintain the chain of custody; (8) Provide immediate health interventions using clinical practice guidelines; (9) Obtain consultations and make referrals to health care personnel and community agencies; (10) Provide immediate crisis intervention at the time of the examination; (11) Provide discharge instructions; (12) Participate in forensic proceedings including courtroom testimony; (13) Interface with law enforcement officials, crime labs, and State attorney's offices; and (14) Assist the licensed physician in performing a forensic evidentiary examination. B. Clinical Practice Guidelines. An RN-FNE may practice only in a clinical setting in which clinical policy and practice guidelines: (1) Have been approved by the facility's medical and nursing departments; (2) Designate the availability of qualified physician resources; (3) Identify the department in which an RN-FNE shall function; and (4) Designate a program coordinator who has experience in forensic evidentiary examinations to administer the RN-FNE training program. C. The program coordinator: (1) Is responsible for obtaining Board approval of the curriculum before conducting a training program; (2) Has responsibility for oversight and administration of the facility’s RN-FNE training program and the practice of the facility’s RN-FNEs; (3) Verifies the qualifications and certifications of any RN-FNE practicing in the facility; (4) Administers and manages the RN-FNE practice; (5) Approves practice protocols and standards of care for RN-FNE practice; (6) Shall develop a peer review process that includes, but is not limited to: (a) Coordinating the peer review of cases; (b) Ensuring that the peer review is consistent with the standardized data collection process; (c) Ensuring that a peer reviewer meets the qualifications in Regulation .05 of this chapter; and (d) Using the standardized form for peer review that is required by the Board; (7) Interfaces with law enforcement, the State's attorney, and community resource groups; (8) Implements the facility's Board-approved RN-FNE curricula; and (9) Facilitates reimbursement for RN-FNE services by cooperating with the facility's billing department and interacting with the State reimbursement system. D. An RN-FNE shall comply with all State and federal statutes and regulations related to the RN-FNE practice. E. An RN-FNE shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .05 Standards for Training Programs. *COMAR 10.27.21.05* A. The Board shall approve two RN-FNE standardized curricula as follows: (1) An RN-FNE-Adult curriculum for the examination of adults and individuals 13 years old or older; and (2) An RN-FNE-Pediatric curriculum for the examination of children who are younger than 13 years old. B. New RN-FNE training programs shall: (1) Be approved by the Board before implementation of the FNE training program; (2) Ensure that the didactic and clinical experiences are the same as existing FNE programs; (3) Teach the Board-approved curriculum in forensic nurse practice and forensic evidentiary examinations; and (4) Submit the qualifications and curriculum vitae of each faculty member to the Board for review before implementation of the training program. C. An application for a new FNE program shall be submitted to the Board at least 6 months before the date of the first class. D. The successful completion of the RN-FNE-Adult training program shall be a prerequisite to admission to the RN-FNE-Pediatric training program. E. The RN-FNE-Adult training program shall include a minimum of 80 clock hours that includes: (1) A minimum of 40 clock hours of theory; and (2) A minimum of 40 clock hours of clinical experience with adults and individuals 13 years old or older. F. The RN-FNE-Pediatric training program shall include a minimum of 62 clock hours that includes: (1) A minimum of 30 clock hours of theory; and (2) A minimum of 32 clock hours of pediatric clinical experience. G. All clinical requirements for an FNE training program shall be completed within a 12-month period. H. Faculty Qualifications. (1) An RN-FNE educator who meets the requirements of this section or a physician whose credentials demonstrate experience in the skills required in forensic evidentiary examinations is qualified to teach both theory and clinical portions of the curriculum and may serve as clinical preceptor for the clinical practicum of the FNE training program. (2) An RN-FNE educator who teaches in an RN-FNE training program or is the clinical preceptor of the training program shall: (a) Be approved by the coordinator of the FNE program: and (i) Have 2 years of experience as an RN-FNE or as a SANE, if from another state; (ii) Have 1 year of FNE experience with ten forensic examinations performed; or (iii) Be deemed by the FNE program coordinator to have the necessary FNE experience and competencies; (b) Have experience teaching the adult learner; (c) Possess broad knowledge and experience in the multidisciplinary treatment approach to family or sexual interpersonal violence, including intervention techniques; and (d) Have either: (i) Qualified as a forensic nurse examiner expert witness in a criminal proceeding; or (ii) Obtained trial preparation experience with the State's attorney's office. (3) The clinical preceptor for the clinical practicum of the FNE training program shall document the clinical competency of the RN-FNE candidate at the completion of the clinical practicum. I. All changes, additions, or deletions to the FNE training program shall be submitted to the Board for approval not later than 3 months before the date of the first class. #### Regulation .06 Certification by Endorsement. *COMAR 10.27.21.06* A. Endorsement Applicant. (1) In addition to the requirement listed in Regulation .03 of this chapter and COMAR 10.27.01.09, an applicant from another state applying for certification to practice as a RN-FNE, RN-FNE-P, or RN-FNE-AP shall: (a) Meet all applicable requirements in §§B—C of this regulation; (b) Provide evidence of an active practice as a sexual assault nurse examiner which meets the requirements for renewal of certification as stated in Regulation .07 of this chapter; (c) Demonstrate competency of a three orifice evidentiary examination by simulation as verified by a Board approved RN-FNE educator; (d) Complete the endorsement process within 6 months from the date of initial application; (e) Complete in full the application for certification in the area of specialization; and (f) Pay all fees established by the Board in COMAR 10.27.01.02. (2) An applicant who does not meet the requirements for renewal under Regulation .07 of this chapter shall complete a Board approved refresher course which is 6.5 hours of didactic education including, but is not limited to: (a) Evidence based best practice for forensic evidentiary examination; (b) Evidence collection; (c) Local jurisdiction requirements; and (d) Maryland criminal law. (3) An applicant who fails to meet the criteria for endorsement shall meet the requirements in Regulation .03 of this chapter. B. An applicant from another state applying for certification to practice as a RN-FNE shall submit evidence of prior training and certification by providing the Board with: (1) A current national SANE-A or SANE-P certification, or both, from IAFN; or (2) Proof of successful completion of a SANE-A or RN-FNE-A, adult curriculum which is: (a) Substantially equivalent to the Board’s approved RN-FNE-A curriculum; and (b) A minimum of 80 clock hours that includes: (i) A minimum of 40 clock hours of theory; and (ii) A minimum of 40 clock hours of clinical experience with adults and individuals 13 years of age or older. C. An applicant from another state applying for certification to practice as a RN-FNE-P or RN-FNE-AP, shall submit proof of successful completion of the following two curricula: (1) A SANE-A curriculum as referenced in §A(1) of this regulation; and (2) A SANE-P or RN-FNE-P, pediatric curriculum that is: (a) Substantially equivalent to the Board-approved RN-FNE-P curriculum; and (b) A minimum of 62 clock hours of instruction that includes: (i) A minimum of 32 clock hours of theory; and (ii) A minimum of 30 clock hours of pediatric clinical experience with individuals who are younger than 13 years of age. #### Regulation .07 Renewal of Certification. *COMAR 10.27.21.07* A. Certification to practice as a FNE expires at the same time as the RN license. B. Beginning January 1, 2016, renewal requirements will change to reflect the 2-year biennial license renewal that was implemented during 2015. C. An FNE who has an even-numbered birth year shall be required: (1) Beginning January 1, 2016, to complete the renewal requirements under §E of this regulation; and (2) Beginning January 1, 2018, to complete the renewal requirements under §F of this regulation. D. Beginning January 1, 2017, an FNE who has an odd-numbered birth year shall be required to complete the renewal requirements under §F of this regulation. E. Before the certification to practice as an RN-FNE expires, the individual may renew for an additional term, if the RN-FNE: (1) Is otherwise entitled to be certified; (2) Has practiced in the role of RN-FNE for a minimum of 400 hours in the previous 24 months in a facility recognized to perform sexual assault forensic evidentiary examinations; (3) Has completed the following evidentiary examinations: (a) If applying for renewal as an RN-FNE-A, three evidentiary examinations on adult patients 13 years of age or older by simulation; (b) If applying for renewal as an RN-FNE-P, three evidentiary examinations on children who are younger than 13 years old; or (c) If applying for renewal as an FNE-AP, three evidentiary examinations on children who are younger than 13 years old, and an additional three evidentiary examinations on adult patients 13 years of age or older by simulation, for a total of six evidentiary examinations performed; or (d) Completed the following requirements: (i) If applying for renewal as an RN-FNE-A, performed ten speculum examinations and observed three evidentiary examinations on adult patients 13 years of age or older; (ii) If applying for renewal as a RN-FNE-P, has observed three evidentiary examinations on children who are younger than 13 years old; (iii) If applying for renewal as an FNE-AP, has observed three evidentiary examinations on children who are younger than 13 years old, has observed an additional three evidentiary examinations on adult patients 13 years of age or older, and performed ten speculum examinations on adult patients 13 years of age or older, for a total of six evidentiary examinations observed and ten speculum examinations performed; and (iv) Have a minimum number of cases submitted to peer review annually in accordance with §G of this regulation; (4) Provides evidence of having obtained a minimum of 8 education clock hours per year in forensic science or forensic nursing; (5) Pays all appropriate renewal fees set forth by the Board in COMAR 10.27.01.02; and (6) Submits an application for renewal of the certification on the form the Board requires. F. Before the certification to practice as an RN-FNE expires, the individual may renew for an additional term, if the RN-FNE: (1) Is otherwise entitled to be certified; (2) Has practiced in the role of RN-FNE for a minimum of 400 hours in the previous 24 months in a facility recognized to perform sexual assault forensic evidentiary examinations; (3) Has completed the following evidentiary examinations: (a) If applying for renewal as an RN-FNE-A, six evidentiary examinations on adult patients 13 years old or older by simulation; (b) If applying for renewal as an RN-FNE-P, six evidentiary examinations on children who are younger than 13 years old; (c) If applying for renewal as an FNE-AP, six evidentiary examinations on children who are younger than 13 years old, and an additional six evidentiary examinations on adult patients 13 years old or older by simulation, for a total of twelve evidentiary examinations performed; or (d) Completed the following requirements: (i) If applying for renewal as an RN-FNE-A, performed twenty speculum examinations and observed six evidentiary examinations on adult patients 13 years old or older; (ii) If applying for renewal as an RN-FNE-P, has observed six evidentiary examinations on children who are younger than 13 years old; or (iii) If applying for renewal as an FNE-AP, has observed six evidentiary examinations on children who are younger than 13 years old, has observed an additional six evidentiary examinations on adult patients 13 years old or older, and has performed ten speculum examinations on adult patients 13 years old or older, for a total of twelve evidentiary examinations observed and ten speculum examinations performed; and (iv) Have a minimum number of cases submitted to peer review annually in accordance with §G of this regulation; (4) Provides evidence of having obtained a minimum of 16 education clock hours per 24 months in forensic science or forensic nursing; (5) Pays all appropriate renewal fees set forth by the Board in COMAR 10.27.01.02; and (6) Submits an application for renewal of the certification on the form the Board requires. G. Peer Review. (1) As a condition of renewal, the following number of cases shall be submitted annually to peer review: (a) Three cases for an RN-FNE-A; (b) Three cases for an RN-FNE-P; and (c) Three adult cases and three pediatric cases for a total of six cases for an RN-FNE-AP. (2) An examination done by simulation may be included in the cases for peer review. H. If the individual does not meet the requirement of §§E(2) and F(2) of this regulation, the individual shall complete a Board-approved course before becoming eligible for renewal of the certification. I. With respect to the requirement set forth in §§E(3) and F(3) of this regulation, an examination performed on a live model or by simulation may substitute for evidentiary examinations for the purpose of certificate renewal. #### Regulation .08 Reinstatement of Certification. *COMAR 10.27.21.08* A. If the applicant does not meet the requirements in Regulation .07 of this chapter, the applicant may apply for re-instatement if the applicant: (1) Either: (a) Has a current, active RN license; or (b) Has a multistate licensure privilege to practice registered nursing; (2) Has not practiced as a RN-FNE for more than 36 months; (3) Has successfully completed a Board-approved refresher course that is 6.5 hours of didactic instruction for the RN-FNE which includes, but is not limited to: (a) Evidence based best practice for forensic evidentiary examination; (b) Evidence collection; (c) Local jurisdiction requirements; and (d) Maryland criminal law; and (4) Has demonstrated clinical competency of a three orifice evidentiary examination for: (a) An adult patient 13 years of age or older or by simulation for certification as an RN-FNE-A; (b) Children younger than 13 years of age for certification as an RN-FNE-P; or (c) An adult patient 13 years of age or older by simulation and by patient examination on children younger than 13 years of age or older for certification as an RN-FNE-AP. B. An applicant for reinstatement of certification has 6 months from the date of initial application to complete the reinstatement process. C. An applicant who fails to meet the criteria for reinstatement of the certification shall meet the requirements in Regulation .03 of this chapter. #### Regulation .09 Unlawful Practice. *COMAR 10.27.21.09* A. Unless authorized to practice under this chapter, an individual may not use the words “forensic nurse examiner” or the acronyms “RN-FNE”, “RN-FNE-A”, “RN-FNE-P”, or “RN-FNE-AP”, or any other words, letters, or symbols with the intent to represent the individual as any category of RN-FNE. B. An individual may not use any form of the designation RN-FNE unless authorized by the Board. C. An individual may not offer to perform or perform the activities of a RN-FNE enumerated in Regulation .04A of this chapter unless certified under this chapter or otherwise permitted by law to engage in these activities. D. A registered or licensed practical nurse may not perform any task or function listed under Regulation .04A of this chapter unless certified under this chapter. E. An individual authorized under this chapter to practice as an RN-FNE is subject to the disciplinary prohibitions and sanctions set forth in Health Occupations Article, Title 8, Annotated Code of Maryland. ### Chapter 22 — Multistate Licensure Compact Regulations **Authority:** Health Occupations Article, §§8-205(a)(1) and 8-7A-01—8-7A-05, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.04 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 140); adopted permanently effective April 17, 2000 (27:7 Md. R. 705) **Administrative History:** Regulation .01B amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .02 amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .02B, C amended effective January 18, 2016 (43:1 Md. R. 13) **Administrative History:** Regulation .03 amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .04 amended effective August 28, 2017 (44:17 Md. R. 835) #### Regulation .01 Definitions. *COMAR 10.27.22.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the regulatory body responsible for issuing nurse licenses. (2) “Information System” means the coordinated licensure information system. (3) “Primary state of residence” means the state of an individual's declared, fixed, permanent, and principal home for legal purposes: domicile. (4) “Public” means any individual or entity other than designated staff or representatives of party state boards or the National Council of State Boards of Nursing, Inc. #### Regulation .02 Issuance of a License by a Compact Party State. *COMAR 10.27.22.02* A. As of July 1, 2005, no applicant for initial licensure will be issued a compact license granting a multistate privilege to practice unless the applicant first obtains a passing score on the applicable NCLEX examination or any predecessor examination used for licensure. B. Home Party State License. (1) A nurse applying for a license in a home party state shall produce evidence of the nurse’s primary state of residence. (2) The evidence required in §B(1) of this regulation shall include a declaration signed by the licensee. (3) Further evidence that may be requested may include but is not limited to a: (a) Driver's license with a home address; (b) Voter registration card displaying a home address; (c) Federal income tax return declaring the primary state of residence; (d) Military Form No. 2058, State of Legal Residence Certificate; or (e) W2 form from the United States government or any bureau, division, or agency thereof indicating the declared state of residence. C. A nurse on a visa from another country applying for licensure in a party state may declare either the country of origin or the party state as the primary state of residence. If the foreign country is declared the primary state of residence, a single state license shall be issued by the party state. D. A license issued by a party state is valid for practice in all other party states unless clearly designated as valid only in the state which issued the license. E. Single State License. (1) When a party state issues a license authorizing practice only in that state and not authorizing practice in other party states, the license shall be clearly marked with words indicating that it is valid only in the state of issuance. (2) A license that is only valid for the party state is called a single state license. F. A nurse changing primary state of residence, from one party state to another party state, may continue to practice under the former home state license and multistate licensure privilege during the processing of the nurse’s licensure application in the new home state for a period not to exceed 90 days. G. The licensure application in the new home state of a nurse under pending investigation by the former home state shall be held in abeyance, and the 90-day period in §F of this regulation shall be stayed until resolution of the pending investigation. H. The former home state license is not valid upon the issuance of a new home state license. I. If a decision is made by the new home state denying licensure, the new home state shall notify the former home state within 10 business days, and the former home state may take action in accordance with that state's laws and regulations. #### Regulation .03 Limitations on Multistate Licensure Privilege — Discipline. *COMAR 10.27.22.03* A. Home state boards shall include, in all disciplinary orders or agreements that limit practice or require monitoring, the requirement that the licensee subject to the order or agreement shall limit the licensee's practice to the home state during the pendency of the disciplinary order or agreement. B. The requirement referred to in §A of this regulation may, in the alternative, allow the nurse to practice in other party states with prior written authorization from both the home state and other party state boards. C. An individual who had a license which was surrendered, revoked, or suspended, or an application denied for cause in a prior state of primary residence, may be issued a single state license in a new primary state of residence until such time as the individual would be eligible for an unrestricted license by the prior state or states where there was an adverse action. D. Once eligible for licensure in the prior state or states, a multistate license may be issued. #### Regulation .04 Information System. *COMAR 10.27.22.04* A. Levels of Access. (1) Public access to nurse licensure information shall be limited to: (a) The licensee's name; (b) Jurisdictions of licensure; (c) Licensure expiration date; (d) Licensure classification and status; (e) Public emergency, summary, and final disciplinary actions, as defined by contributing state authority; and (f) The status of multistate licensure privileges. (2) Non-party state boards shall have access to all Information System data except current significant investigative information and other information as limited by contributing party state authority. (3) Party state boards shall have access to all Information System data contributed by the party states and other information as allowed by contributing non-party state authority. B. Right to Review. (1) The licensee may request, in writing, to the home state board to review data relating to the licensee in the Information System. (2) If a licensee asserts that any data relating to the licensee is inaccurate, the burden of proof is on the licensee to provide evidence substantiating that claim. (3) Within 10 business days, the Board shall correct information that it finds to be inaccurate in the Information System. C. Changes in Disciplinary Data. (1) Within 10 business days, the Board shall report to the Information System: (a) Disciplinary action, agreement, or order requiring participation in alternative programs or which limit practice or require monitoring unless the agreement or order relating to participation in alternative programs is required to remain nonpublic by the contributing state authority; (b) Dismissal of the complaint; and (c) Changes in status of disciplinary action, or licensure encumbrance. (2) The Board shall delete current significant investigative information from the Information System within 10 business days after: (a) A disciplinary action; (b) An agreement or order requiring participation in alternative programs; (c) An agreement or agreements which limit practice or require monitoring; or (d) Dismissal of a complaint. (3) The Information System administrator shall make changes to licensure information in the Information System within 10 business days upon notification by a board. ### Chapter 23 — Code of Conduct for Board Members and Investigators **Authority:** Health Occupations Article, §8-205(a)(1), Annotated Code of Maryland **Administrative History:** Effective date: December 25, 2000 (27:25 Md. R. 2282) #### Regulation .01 Scope. *COMAR 10.27.23.01* This chapter establishes a code of conduct for: A. Members of Board of Nursing; and B. Investigators employed by the Board of Nursing. #### Regulation .02 Definitions. *COMAR 10.27.23.02* A. In this chapter, the following terms have the meanings indicted. B. Terms Defined. (1) “Board” means the Board of Nursing. (2) “Board member” means an individual appointed by the Governor to serve on the Board. (3) “Charging document” means the notice from the Board pursuant to State Government Article, §10-208, Annotated Code of Maryland, which informs a licensee of an alleged violation or violations of a Board's statute by the licensee. (4) “Complaint” means a communication to a Board of a possible violation of the disciplinary provisions outlined in Health Occupations Code, Title 8, Annotated Code of Maryland. (5) “Conflict of interest” means a situation in which a personal interest of a Board member or a Board investigator presents a potential conflict with the public interest in connection with an anticipated public action or decision. (6) “Ex parte communication” means a direct or indirect communication between a Board member and another party regarding the merits of an issue in a pending contested disciplinary case, if the communication is made outside the presence of the opposing party. (7) “Investigator” means an individual who investigates complaints received by the Board. (8) “Recusal” means nonparticipation of a Board member in a specific matter before the Board. #### Regulation .03 Recusal of Board Members. *COMAR 10.27.23.03* A. Standard for Recusal. (1) A Board member shall recuse himself or herself from Board proceedings which involve situations in which the Board member: (a) Has a conflict of interest; or (b) Cannot participate fairly and impartially. (2) Personal familiarity with a respondent does not, of itself, require recusal of a Board member. (3) A Board member may seek advice of the Board's counsel in determining the need for recusal on a specific matter. B. Recusal. (1) The Board member who is recused from a matter before the Board, may not: (a) Participate in the Board's discussion or vote on the matter; or (b) Discuss the matter or the Board's review of the matter with members of the Board or other individuals. (2) If the matter before the Board is a disciplinary matter, the Board member who is recused shall physically leave the room to ensure nonparticipation. (3) The Board shall document the recusal of the Board member in the minutes of the Board meeting. C. Recusal for Complaint Against a Board Member. (1) A Board member against whom a complaint is filed shall follow §B of this regulation for all discussion and voting concerning the complaint filed against the Board member. (2) If the Board determines that there is an additional matter before the Board which is reasonably related to the complaint filed against the Board member, the Board member against whom the complaint is filed shall follow §B of this regulation for the additional matter also. (3) If, after investigation of the complaint, the Board refers the case to the Attorney General's Office, the Board member shall recuse himself or herself from all Board activities until the final disposition of the case. #### Regulation .04 Investigator. *COMAR 10.27.23.04* A. An investigator may not conduct or participate in an investigation of a complaint in which the investigator has a conflict of interest. B. In the investigation of a complaint against a member of a Board, the Board may consider using an investigator other than the investigator who is regularly assigned to conduct investigations for the Board. #### Regulation .05 Confidentiality. *COMAR 10.27.23.05* A. A Board member or investigator may not discuss disciplinary or other confidential matters with a person other than: (1) A Board member; (2) Board staff; (3) The Attorney General's Office; (4) A witness; or (5) Another person authorized by law to be involved in the case. B. In the case of an ex parte communication, the Board member shall follow the provisions of the State Government Article, §10-219, Annotated Code of Maryland. ### Chapter 24 — Compelling Purpose Disclosure **Authority:** State Government Article, §10-617(h)(3), Annotated Code of Maryland **Administrative History:** Effective date: July 23, 2001 (28:14 Md. R. 1322) #### Regulation .01 Disclosure for Compelling Public Purpose. *COMAR 10.27.24.01* A custodian of Board records may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, whether or not there has been a request for the information under the following circumstances: A. There is possible criminal activity and the disclosure is to a federal, state, or local law enforcement or prosecutorial official or authority; B. There is possible violation of law and the disclosure is to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation or over a facility in which the individual has practiced and the information disclosed is limited to that information relevant to the possible violation by that individual; or C. There is conduct by an individual that the Board reasonably believes may pose a risk to the public health, safety, or welfare and the disclosure is to a law enforcement authority, administrative official, or agency that regulates the individual or regulates a facility in which the individual has practiced, or to a hospital or other health care facility where the individual has privileges. #### Regulation .02 Other Disclosures. *COMAR 10.27.24.02* This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information which the Board may otherwise disclose by law. ### Chapter 25 — Cosmetic Procedures **Authority:** Health-General Article, §4-403; Health Occupations Article, §8-205(a)(1) and (2); Annotated Code of Maryland **Administrative History:** Effective date: May 30, 2011 (38:11 Md. R. 671) **Administrative History:** Regulation .05E adopted effective October 13, 2025 (52:20 Md. R. 1002) #### Regulation .01 Exclusion from Regulations. *COMAR 10.27.25.01* A. This chapter is not applicable to, and does not restrict or limit, other health care practitioners who are authorized to perform these duties under their respective practice acts. B. This chapter does not restrict or limit a Maryland Certified Registered Nurse Practitioner from possessing, prescribing, evaluating, or performing the procedures under this chapter. #### Regulation .02 Definitions. *COMAR 10.27.25.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Body treatment” means cellulite lymphatic drainage and cellulite vacuum massage. (2) “Cellulite lymphatic drainage” means a therapy in which the practitioner uses a range of specialized and gentle rhythmic pumping techniques to move the skin in the direction of the lymph flow. (3) “Cellulite vacuum massage” means: (a) The massage of peripheral blood, lymph, and inter-tissue liquid with the goal of reducing stagnation of these fluids and increasing the skin’s elasticity; and (b) The external use of a vacuum component directly on the area to be massaged followed by a straight line, circular, or zigzag movement to massage the area. (4) “Chemical peels” also called deep skin peels, means the removal of the top layers of skin using chemicals applied directly to the skin. (5) “Clinical preceptor” means a licensed or certified individual who is: (a) Proficient in the procedure for which they are precepting; and (b) Permitted by the appropriate health occupation licensing board to provide care and treatment for cosmetic services. (6) “Cryotherapy” means the application of: (a) Extreme cold to destroy abnormal or diseased tissue, warts, moles, skin tags, and solar keratoses; and (b) Liquid nitrogen to freeze tissues at the cellular level. (7) “Dermal fillers” means various types of natural or man-made materials which are injected intradermally to correct imperfections in the skin and subcutaneous tissue. (8) “Direct supervision” means on site, physically present, accessible in the immediate patient care area and available to intervene if necessary. (9) “Injectable treatments” means the use of FDA approved medication and includes the following: (a) Dermal fillers; (b) Micropigmentation, also known as cosmetic tattoo or permanent make-up; and (c) Neuromuscular agents. (10) “Laser treatment” means a technique in which exposure to low-level laser light or light emitting diodes are used to stimulate or inhibit cellular function possibly leading to beneficial clinical effects. (11) Light Treatment. (a) “Light treatment” also known as phototherapy, means the use of non-ionizing electro-magnetic radiation for therapeutic benefit. (b) “Light treatment” does not mean laser treatment. (12) “Lipodissolve” means a procedure that uses subcutaneous micro-injections of drugs with the sole purpose of dissolving fat for body contouring. (13) Magenta Light. (a) “Magenta light” means a non-invasive technique that combines infrared and magenta light with subdermal tissue massage to produce a penetrating light that affects the epidermis, alters cellulite formation, and controls cellulite formation at the cellular level. (b) “Magenta light” does not mean laser or intensive pulse light. (14) “Mesotherapy” also known as intradermotherapy, means a non-invasive cosmetic treatment which employs multiple intra or subcutaneous injections of pharmaceutical and homeopathic medications, plant extracts, vitamins, and other ingredients for the treatment of fat or cellulite. (15) “Micro current treatment” means passing radio frequency electricity through the skin to: (a) Heat up tissue; (b) Cause the tissue to contract; and (c) Stimulate collagen production. (16) “Neuromuscular agents” means injectable drugs that cause muscle weakness for the purpose of cosmetic softening of wrinkles and includes, but is not limited to, Botox and Dysport. (17) “Nurse” means a registered nurse (RN) or a licensed practical nurse (LPN). (18) “Peels” or “Topicals” means: (a) Chemicals peels; (b) Cryotherapy; or (c) Microdermabrasion. (19) “Photochemotherapy” means the use of a photodynamic light source to destroy dystrophic cells. (20) “Photodynamic (PDT)” means the use of a light source, combined with a light-sensitive drug to destroy dystrophic cells. (21) “Photosensitizing agent” means a drug used with a photodynamic light source to produce a therapeutic photosensitivity. (22) “Precepted clinical practice” means after theoretical learning and until competency is achieved: (a) Working directly with patients; (b) Performing cosmetic or dermatologic procedures on patients; and (c) Working under the direct supervision of a clinical preceptor who has the knowledge and ability to perform the procedure independently. (23) Radio Frequency and Current. (a) “Radio frequency and current” means: (i) Magenta light; (ii) Microcurrent treatment; (iii) Photochemotherapy; (iv) Photodynamic; (v) Thermage; and (vi) Ultrasound (therapeutic only). (b) “Radio frequency and current” does not mean laser. (24) Theory. (a) “Theory” means the body of knowledge regarding the principles underlying the safe execution of a cosmetic procedure and is obtained through didactic instruction provided by a licensed health care provider who has the knowledge and skill to perform the procedure. (b) “Theory” includes didactic instruction by the licensed health care provider which may be augmented by a manufacturer’s representative. (25) “Thermage” means the use of radio frequency technology to: (a) Target collagen in the dermis layer of the skin around the eyes and forehead; and (b) Cause the dermis and underlying tissue to tighten. (26) Ultrasound. (a) “Ultrasound” means the therapeutic use of inaudible sound in the frequency range of approximately 20,000 to 10,000,000,000 cycles per second for therapeutic use at low intensity producing a heating effect to stimulate collagen production. (b) “Ultrasound” does not mean the use of ultrasound for diagnostic purposes. #### Regulation .03 Procedural Categories. *COMAR 10.27.25.03* A. Procedures designated as Category A shall include body treatments with: (1) Cellulite lymphatic drainage; and (2) Cellulite vacuum massage. B. Procedures designated as Category B shall include light treatments with: (1) Infrared light; (2) Magenta light; (3) Photochemotherapy; (4) Photodynamic; (5) Photosensitizing agents; (6) UVA light; and (7) UVB light. C. Procedures designated as Category C shall include laser treatments administered by a selective laser. D. Procedures designated as Category D shall include injectable treatments with: (1) Dermal fillers; (2) Micropigmentation with topical anesthetics only; and (3) Neuromuscular agents. E. Procedures designated as Category E shall include radio frequency and current treatments with: (1) Micro current; (2) Thermage; and (3) Ultrasound. F. Procedures designated as Category F shall include peels or topicals with: (1) Chemical peels; (2) Cryotherapy; (3) Microdermabrasion; and (4) Power peel. #### Regulation .04 Education. *COMAR 10.27.25.04* To administer medication or to perform cosmetic and dermatologic treatments, a nurse shall: A. Complete a program of study that includes theory appropriate to the medication to be administered and the procedure to be performed that includes, but is not limited to: (1) Anatomy, physiology, and pathophysiology related to the integumentary system as well as systems specific to the procedure being performed; (2) Appropriate technique for each cosmetic procedure; (3) Nursing assessment, cosmetic indications, and contraindications for treatment; (4) Pharmacology intervention specific to the cosmetic procedure including, but not limited to: (a) Assessment and monitoring of the receiving the medication; (b) Effects and potential side effects of the medication; (c) Contraindications to the administration of the medication; (d) The ability to anticipate and recognize potential complications of the medication; (e) The ability to recognize emergency situations and institute appropriate interventions; (f) Preparation, storing, and handling of the medication; and (g) Proficiency in administering the medication by the required route; (5) Selection, maintenance, and utilization of equipment; (6) Identification of realistic and expected outcomes of the procedure; (7) Identification of complications or adverse reactions; (8) Nursing care required and appropriate nursing interventions in the event of complications or untoward outcomes; (9) Infection control procedures; (10) Safety precautions appropriate to each procedure; (11) Documentation appropriate to the type of the procedure being performed; and (12) Precepted clinical practice by a clinical preceptor that includes documented initial and annual competency of the nurse in each cosmetic procedure the nurse is to perform; B. Document evidence of clinical and psychomotor proficiency competency before independently performing each cosmetic procedure; C. Perform the procedures on a frequent routine predictable basis in order to retain practice proficiency; D. Be evaluated for continued clinical competency at periodic intervals; and E. Obtain additional education when the population changes or new procedures are introduced into the practice. #### Regulation .05 Cosmetic Procedures in General. *COMAR 10.27.25.05* A. The nurse shall comply with the employment settings written cosmetic policies and procedures that comply with this chapter. B. The nurse shall be guided by and comply with the written policies and procedures in keeping with recognized standards of care that include, but are not limited to: (1) Care and maintenance of appropriate equipment and safe operation; (2) Description of how the procedure is to be performed; (3) Education; (4) Assessment; (5) Emergency procedures; (6) Monitoring guidelines; (7) Operator and safety when utilizing equipment; (8) A continuous quality improvement process which includes, but is not limited to: (a) Unexpected outcomes; (b) Side effects; and (c) Complications; (9) Obtaining or ensuring that the client’s informed consent has been obtained that documents the patient’s awareness that it is the licensed nurse who will perform the cosmetic procedure; and (10) Documenting the performance of the cosmetic procedure including, but not limited to: (a) Patient response; (b) Patient education; and (c) Safety precautions taken on behalf of the patient. C. The nurse may perform the identified cosmetic procedure when there is a completed prescriptive order from an authorized prescriber that includes, but is not limited to: (1) The procedure to be performed; (2) Identification of the specific treatment area; (3) Identification of medication, dosage, route, and time interval for administration of the medication for the specific cosmetic procedure; (4) Identification of the light source and the radio frequency, current dosage, intensity, and time period it is to be applied; and (5) The use of any topical anesthetic. D. Before a nurse performs any of these cosmetic procedures, the authorized prescriber shall: (1) Complete an initial assessment and evaluation of the patient before the procedure is performed; (2) Develop a treatment plan for the specific patient; (3) Be physically present in the setting; and (4) Be immediately available: (a) At the time the procedure is performed; and (b) Post-treatment to evaluate the patient. E. The nurse shall maintain medical records in accordance with Health-General Article, Title 4, Subtitle 4, Annotated Code of Maryland. #### Regulation .06 Cosmetic Procedures — Licensed Practical Nurse. *COMAR 10.27.25.06* Except for Category C, the LPN may perform the cosmetic procedures identified in Regulation .03 of this chapter. #### Regulation .07 Cosmetic Procedures — RN. *COMAR 10.27.25.07* The RN may perform all of the procedures identified in Regulation .03 of this chapter. #### Regulation .08 Exceptions. *COMAR 10.27.25.08* Except for cryotherapy, the nurse may perform the cosmetic procedures identified in Regulation .03 Category F independent of the requirements stated in Regulation .05D of this chapter. #### Regulation .09 Prohibited Acts. *COMAR 10.27.25.09* A. The licensed nurse may not: (1) Perform cosmetic procedures on a standing order or protocol; (2) Perform the pre-procedure medical assessment or evaluation; (3) Perform medical diagnosis or prescribe cosmetic procedures; (4) Develop the client treatment plan; (5) Prescribe medications for cosmetic or dermatological procedures; (6) Perform the post-procedure medical evaluation of the client; and (7) Administer injections for the purpose of: (a) Mesotherapy; and (b) Lipodissolve. B. The nurse may not perform: (1) Liposuction; (2) Hair transplants; (3) Invasive radiofrequency procedures; (4) Phenopeels; (5) Sculptra injections; and (6) Lipostabil or phosphatidycholine for the purpose of lipodissolve. ### Chapter 26 — Sanctioning Guidelines **Authority:** Health Occupations Article, §§1-606, 8-205(a)(1), 8-316, 8-6A-10, 8-6B-18, 8-6C-20, and 8-6D-10, Annotated Code of Maryland **Administrative History:** Effective date: April 16, 2012 (39:7 Md. R. 492) **Administrative History:** Regulation .02B amended effective September 10, 2018 (45:18 Md. R. 834) **Administrative History:** Regulation .07M amended effective September 10, 2018 (45:18 Md. R. 834) #### Regulation .01 Scope. *COMAR 10.27.26.01* A. This chapter shall be used by the Board as a guide for sanctioning licensees and certificate holders in formal and informal disciplinary proceedings. B. The Board shall take into consideration a range of activity within certain types of conduct rather than assigning particular sanctions to each specific violation. C. There may be conduct by a licensee or certificate holder that does not fall squarely within a particular category of misconduct contained in Regulation .07 of this chapter. In that event, the Board will use its discretion to determine the appropriate category and sanction. D. The Board shall make determinations that maximize the protection of the public’s health while maintaining the rights of licensees and certificate holders. #### Regulation .02 Definitions. *COMAR 10.27.26.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland State Board of Nursing. (2) “Certificate holder” means an individual who has been issued a certificate by the Board to practice as a certified nursing assistant, a certified dialysis technician, or a certified medication technician. (3) “Conditions” means any requirements in a public or nonpublic order that a licensee or certificate holder is required to satisfy, which include, but are not limited to: (a) Treatment and counseling for a psychological or physical illness, including, but not limited to substance abuse; (b) Submission to drug and alcohol testing; (c) Abstinence from specified drugs; (d) Abstinence from alcohol; (e) Remedial training; (f) Inspection of a private practice site; (g) Monitoring; (h) Evaluation; (i) Supervision; (j) Compliance with a rehabilitation agreement; (k) Testing of clinical skills; (l) Submission of written reports; (m) A demonstration of knowledge or competency; (n) Submit to a physical or mental health examination; (o) Limitation of practice; and (p) Limitation on the administration of prescription or specified drugs to clients. (4) “Conduct” means behavior or action or a failure to behave or act, which results in a violation of the Maryland Nurse Practice Act or regulations adopted by the Board. (5) “Licensee” means an individual who: (a) Has been issued a license or certification by the Board to practice as: (i) A registered nurse; (ii) A licensed practical nurse; (iii) An advanced practice registered nurse; (iv) An electrologist; (v) A licensed direct-entry midwife; or (vi) A licensed certified midwife; or (b) Has a multistate licensure privilege to practice licensed practical nursing or registered nursing under the Nurse Licensure Compact. (6) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (7) “Recklessly” means characterized by the creation of a substantial and unjustifiable risk of harm to others and by a conscious, sometimes deliberate, disregard for or indifference to that risk. (8) “Sanction” means a disciplinary action against a licensee or certificate holder, including a reprimand, probation, suspension, revocation, or a monetary penalty. #### Regulation .03 Application. *COMAR 10.27.26.03* A. This chapter is not applicable to cases in which the Board, after investigating a matter, decides to issue a public advisory letter in lieu of discipline in accordance with Health Occupations Article, §8-317(h) or 8-6B-19(h), Annotated Code of Maryland. B. This chapter is not applicable to: (1) An individual seeking an initial license or certificate; or (2) The summary suspension of a licensee or certificate holder under State Government Article, §10-226, Annotated Code of Maryland, or Health Occupations Article, §8-317(g), Annotated Code of Maryland. C. This chapter is not applicable to violations for which a mandatory sanction or penalty is set by statute or regulation. D. The severity of sanctions is ranked as follows, from least severe to most severe: (1) Reprimand; (2) Probation; (3) Suspension; and (4) Revocation. E. The addition of a monetary penalty to a sanction does not change the ranking of the severity of the sanction. F. If a monetary penalty is added to a sanction, a sanction with a higher monetary penalty is more severe than the same sanction with a lesser monetary penalty. G. When a licensee or certificate holder’s conduct results in multiple violations of the Maryland Nurse Practice Act or regulations adopted by the Board, the Board: (1) May consider sanctions that are greater than those imposed for a single violation; and (2) Has discretion to apply the category with the highest maximum sanction. H. In the event that a licensee’s or certificate holder’s violation of the Maryland Nurse Practice Act or regulations adopted by the Board does not fall within a particular category of misconduct included in Regulation .07 of this chapter, the Board shall: (1) Use its discretion to determine the appropriate sanction; and (2) Consider, to the extent possible, the sanctioning guidelines set forth in Regulation .07 of this chapter. I. In the event that the Board determines that a licensee’s or certificate holder’s violation of the Maryland Nurse Practice Act or regulations adopted by the Board falls within more than one category of misconduct established under Regulation .07 of this chapter, the Board shall, in its discretion, determine the category under which the violation shall be adjudicated. J. The period of a suspension may be stayed in whole or in part. K. Any sanction imposed by the Board in accordance with the sanctioning guidelines set forth in Regulation .07 of this chapter may be accompanied by conditions reasonably related to the violation or to the rehabilitation of the licensee or certificate holder. L. The inclusion of conditions with any sanction is within the discretion of the Board and does not factor into a determination of whether a particular sanction falls within or outside of the sanctioning guidelines set forth in Regulation .07 of this chapter, nor does it increase the severity of the sanction. M. The Board is not required to make findings of fact or to articulate its reasoning for imposing a sanction that falls within the range of sanctions set forth in Regulation .07 of this chapter. N. If the Board imposes a sanction that departs from the sanctioning guidelines set forth in Regulation .07 of this chapter, the Board shall state its reasons for doing so in its final decision and order. O. A departure from the sanctioning guidelines set forth in Regulation .07 of this chapter is not a ground for any hearing or appeal of a Board action. P. To resolve a pending disciplinary matter, the Board and licensee or certificate holder may agree to a consent order or the surrender of the license or certificate under terms and conditions agreed to by the Board and the licensee or certificate holder. #### Regulation .04 Aggravating and Mitigating Factors. *COMAR 10.27.26.04* A. Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the sanctioning guidelines set forth in Regulation .07 of this chapter. B. Aggravating factors include, but are not limited to: (1) A prior criminal or administrative discipline history; (2) Whether the violation was committed: (a) Deliberately (b) With gross negligence; or (c) Recklessly; (3) Whether the violation has the potential for, or caused, serious harm; (4) Whether the violation was a part of a pattern of unacceptable conduct; (5) Whether the licensee or certificate holder pursued their own financial gain over another individual’s welfare; (6) Whether the individual affected by the violation was vulnerable; (7) Whether the licensee or certificate holder attempted to hide the error or misconduct from clients or others; (8) Whether the licensee or certificate holder: (a) Concealed, falsified, or destroyed evidence; or (b) Presented false testimony or evidence; (9) Whether the licensee or certificate holder failed to cooperate with a lawful investigation conducted by the Board; and (10) Whether previous attempts to rehabilitate the licensee or certificate holder were unsuccessful. C. Mitigating Factors include, but are not limited to: (1) Absence of a prior disciplinary record; (2) The length of time since any prior violation; (3) Whether the licensee or certificate holder self-reported to the Board; (4) Voluntary admission of misconduct with full disclosure to the Board and cooperation with the Board’s investigation; (5) Implementation of remedial measures to correct or mitigate harm arising from the misconduct; (6) Timely good-faith efforts to make restitution or to rectify consequences of misconduct; (7) Evidence of rehabilitation or rehabilitative potential; (8) Absence of actual or potential harm; (9) Absence of adverse impact; and (10) Whether the violation was an isolated incident and not likely to recur. D. The existence of one or more aggravating or mitigating factors does not impose any requirement on the Board to make findings of fact or to articulate its reason for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in Regulation .07 of this chapter. E. Nothing in this regulation requires the Board to make findings of fact with respect to the existence or nature of any aggravating or mitigating factor. #### Regulation .05 Imposition of a Monetary Penalty. *COMAR 10.27.26.05* A. Instead of or in addition to a reprimand, probation, suspension, or revocation, the Board may impose a monetary penalty in accordance with Health Occupations Article, §8-316(b), 8-6A-10(b), or 8-6B-20, Annotated Code of Maryland. B. Subject to consideration of the aggravating and mitigating factors set forth in Regulation .04 of this chapter, if the Board elects to impose a monetary penalty, the Board shall use the sanctioning guidelines set forth in Regulation .07 of this chapter to determine an appropriate monetary penalty. #### Regulation .06 Payment of a Monetary Penalty. *COMAR 10.27.26.06* A. The licensee or certificate holder shall pay any monetary penalty imposed by the Board under the provisions of this chapter: (1) By cashier’s check or money order made payable to the Board; (2) Within 60 days of the date of the order; and (3) In person or by certified mail to the Board. B. The Board shall pay all monies collected by the Board under the provisions of this chapter into the General Fund of the State. C. Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §8-318, 8-6A-11, or 8-6B-21, Annotated Code of Maryland, does not automatically stay payment of a monetary penalty imposed by the Board under this chapter. D. If a licensee or certificate holder fails to pay, in whole or in part, a monetary penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license or certificate until the monetary penalty has been paid in full. E. In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. #### Regulation .07 Sanctioning Guidelines. *COMAR 10.27.26.07* Subject to the provisions of this chapter, the Board may impose sanctions for violations of the Maryland Nurse Practice Act and its regulations according to the guidelines set forth in the following categories: A. Abuse — Physical and Psychological. B. Criminal History. C. Disciplined by Another Licensing, Military, or Disciplinary Authority. D. Diversion of Controlled Substances or Prescription Drugs or Manufacture, Sale, or Distribution of any Substance for an Illegal or Illegitimate Purpose. E. Noncompliance with Board Orders. F. Practice Inconsistent with Generally Accepted Standards of Care. G. Sexual Misconduct. H. Substance Abuse. I. Unauthorized Practice. J. Unprofessional Conduct. K. Physical or Mental Incompetence. L. Fraud, Deceit, or Misrepresentation. M. Expulsion from Safe Practice Program. ### Chapter 27 — Practice of Clinical Nurse Specialist **Authority:** Health Occupations Article, §§8-205(a)(1), (2), (4), and (5) and 8-302(b)(1)(iii) and (2)(ii), Annotated Code of Maryland **Administrative History:** Effective date: October 1, 2012 (39:19 Md. R. 1236) **Administrative History:** Regulation .02D amended as an emergency provision effective September 1, 2014 (41:19 Md. R. 1074); emergency status expired effective February 27, 2015 **Administrative History:** Regulation .02C, D repealed effective April 13, 2015 (42:7 Md. R. 569) **Administrative History:** Chapter revised effective July 2, 2018 (45:13 Md. R. 667) **Administrative History:** Regulation .01B amended effective November 14, 2022 (49:23 Md. R. 996) **Administrative History:** Regulation .04 amended effective November 14, 2022 (49:23 Md. R. 996) #### Regulation .01 Definitions. *COMAR 10.27.27.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advanced practice registered nurse (APRN)” means a registered nurse who is certified by the Board as: (a) A certified nurse midwife (CNM); (b) A certified registered nurse anesthetist (CRNA); (c) A certified nurse practitioner (CRNP); or (d) A clinical nurse specialist (CNS). (2) “Board” means the Board of Nursing. (3) “Certification” means the permission to practice as a clinical nurse specialist granted by the Board to a registered nurse who: (a) Met all the specified requirements of a national certifying body recognized by the Board; and (b) Complied with the requirements of this chapter. (4) “Clinical nurse specialist” means an advanced practice registered nurse certified by the Board to practice as a clinical nurse specialist in this State. (5) “Multistate licensure privilege” has the meaning set forth in COMAR 10.27.01.01B. (6) “Registered nurse (RN)” means an individual who: (a) Is licensed by the Board to practice registered nursing; or (b) Has a multistate licensure privilege to practice registered nursing. (7) “Standard of care” means the practice of clinical nurse specialist in accordance with the core competencies and behaviors specified by the National Association of Clinical Nurse Specialists (NACNS), American Nurse Credentialing Center (ANCC), American Association of Critical Care Nurses (AACN), or other national certifying body recognized by the Board. (8) “System” means the setting within which the clinical nurse specialist is practicing. #### Regulation .02 Certification. *COMAR 10.27.27.02* A. An applicant for certification as a clinical nurse specialist shall: (1) Hold a current Maryland license in good standing to practice registered nursing or a multistate licensure privilege to practice registered; (2) Have graduated from a Board-approved graduate level education program for a clinical nurse specialist at the master’s level or higher that is accredited by; (a) The National League for Nursing Accreditation Commission (NLNAC); (b) The Commission on Nursing Education (CCNE); or (c) Any other accrediting body recognized by the Board; (3) Successfully complete a national certifying exam recognized by the Board for national certification as a clinical nurse specialist in the applicant’s area of practice; (4) Hold a current national certification as a clinical nurse specialist from a national certifying body recognized by the Board; (5) Submit to the Board a completed application for certification as a clinical nurse specialist on a form required by the Board; (6) Comply with all requirements set forth in COMAR 10.27.01.04; (7) Demonstrate oral and written competency in the English language; and (8) Pay all fees. B. Beginning on October 1, 2012, as long as the applicant remains certified and in good standing, the Board shall deem that an applicant meets the qualifications to be certified as a clinical nurse specialist if the applicant has: (1) Been licensed as a registered nurse in Maryland or has a multistate privilege to practice registered nursing; (2) Obtained a master’s degree or higher in Nursing; (3) Practiced as a clinical nurse specialist; and (4) One of the following: (a) An active certification as a clinical nurse specialist from a national certification body recognized by the Board; (b) An active national certification at the highest level in the applicant’s area of practice; or (c) A national certification at the highest level in the applicant’s area of subspecialty. #### Regulation .03 Renewal of Certification. *COMAR 10.27.27.03* A. Certification as a clinical nurse specialist expires at the same time as the clinical nurse specialist’s registered nursing license. B. Before a clinical nurse specialist’s certification expires, the clinical nurse specialist may renew the certification biennially if the clinical nurse specialist: (1) Is otherwise entitled to be certified; (2) Submits to the Board: (a) A completed renewal application for clinical nurse specialists on a form that the Board requires; and (b) Documentation of current national certification as a clinical nurse specialist from a national certifying body recognized by the Board; and (3) Pays all fees. C. Clinical nurse specialists renewal applicants who are authorized to practice registered nursing in this State under a multistate licensure privilege shall be periodically required to submit to a criminal history records check in accordance with the schedule and requirements set forth in COMAR 10.27.01.13J — N. D. The clinical nurse specialist shall ensure that the Board has a record of the renewed national certification if the national certification expires before the registered nurse license renewal date. E. Certification as a clinical nurse specialist shall be deemed to have lapsed if the Board does not have a record of a current active national certification. F. Practicing on an expired national certification is prohibited and is subject to discipline under Health Occupations Article, §8-316(a), Annotated Code of Maryland. #### Regulation .04 Scope and Standards of Practice. *COMAR 10.27.27.04* A. The unique role of the clinical nurse specialist is to: (1) Integrate care across the continuum and through three spheres of impact: (a) The patient; (b) The nurse; and (c) The system; and (2) Ranges from: (a) Wellness to illness; and (b) Acute to chronic care. B. The clinical nurse specialist provides direct care to patients with complex needs, acts as a consultant, conducts research, and provides education and guidance for staff nurses. C. The practice of the clinical nurse specialist encompasses the continuous improvement of patient outcomes and nursing care. D. The clinical nurse specialist shall adhere to standards of clinical practice, scope of practice, and the standards of professional performance in accordance with this chapter. E. The scope of practice of the clinical nurse specialist includes, but is not limited to: (1) Practicing with individual clients, families, groups, and populations of clients; (2) Performing a comprehensive physical assessment of patients; (3) Establishing medical diagnosis for common short-term and chronic stable health problems; (4) Diagnosing, treating, and managing patients with acute and chronic illness or disease, or both; (5) Ordering, performing, and interpreting laboratory tests; (6) Ordering diagnostic tests and using the findings or results in the care of patients (7) Initiating, monitoring, and altering appropriate therapies or treatments; (8) Providing primary health care, including health promotion and disease prevention by assessing, educating, and providing referrals for the patient, family, and caregiver; (9) Providing emergency care; (10) Referring patients to appropriate licensed physicians or other health care providers as needed; (11) Consulting or collaborating with a licensed physician or other health care provider as needed; and (12) Creating therapeutic environments through mentoring and system changes to: (a) Develop caring, evidence-based practices; (b) Facilitate ethical decision making; (c) Respond to diversity; and (d) Alleviate patient distress. #### Regulation .05 Practice Before Certification. *COMAR 10.27.27.05* A. A registered nurse who has completed the education requirements for the advanced practice of a clinical nurse specialist and has registered for a national certifying exam recognized by the Board may practice in this State as a clinical nurse specialist graduate if the registered nurse has: (1) A current license to practice registered nursing in this State or holds a multistate licensure privilege to practice registered nursing; (2) Submitted a completed application for certification as a clinical nurse specialist graduate; and (3) Submitted satisfactory evidence that the applicant has applied to take a national certifying exam recognized by the Board and has been accepted as a candidate for the exam. B. A clinical nurse specialist graduate shall practice under the direct supervision of a certified clinical nurse specialist. C. A clinical nurse specialist graduate shall cease practice immediately if the clinical nurse specialist graduate fails the required national certification exam as required in Regulation .02A(3) of this chapter. D. A clinical nurse specialist graduate who fails the national certification exam may continue to work as a registered nurse until the clinical nurse specialist graduate passes a national certifying exam for clinical nurse specialist. #### Regulation .06 Unlawful Practices. *COMAR 10.27.27.06* A. Unless authorized to practice under this chapter, an individual may not use the following words or abbreviations: (1) Certified clinical nurse specialist; (2) Clinical nurse specialist (CNS); (3) Clinical Registered Nurse Specialist (CRNS); (4) Clinical nurse specialist graduate; or (5) Nurse specialist graduate. B. An individual certified under this chapter shall be subject to disciplinary prohibitions and sanctions set forth under Health Occupations Article, §§8-316 and 8-701 — 8-703, Annotated Code of Maryland. ### Chapter 28 — Delegation of Acts by an Advanced Practice Registered Nurse **Authority:** Health Occupations Article, §§8-205 and 8-6A-02, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .06 adopted as an emergency provision effective August 26, 2025 (52:20 Md. R. 999); adopted permanently effective October 27, 2025 (52:21 Md. R. 1024) #### Regulation .01 Scope. *COMAR 10.27.28.01* A. This chapter governs the delegation of nursing or other technical tasks by an advanced practice registered nurse to an assistant not otherwise authorized under Health Occupations Article, Annotated Code of Maryland. B. This chapter may not be construed: (1) As establishing the licensure, certification, or registration of assistants by the Board; (2) To apply to an individual who is licensed, certified, or registered by a health occupations regulatory board, or health occupation students, acting pursuant to Health Occupations Article, Annotated Code of Maryland; and (3) To mean that this chapter overrides, or is to be used in lieu of, more stringent regulations, policies, and procedures established by State licensure or certification requirements. #### Regulation .02 Definitions. *COMAR 10.27.28.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advanced practice registered nurse (APRN)” has the meaning stated in Health Occupations Article, §8-101, Annotated Code of Maryland. (2) “Assistant” means an individual: (a) To whom only routine nursing and technical tasks are delegated by an advanced practice registered nurse; (b) Who is trained as defined in §B(12) of this regulation; and (c) Who is not licensed, certified, registered, or otherwise authorized by law by the Board, or any other State health occupations board, to practice any health occupation in the State. (3) “Asynchronous telehealth interaction” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland. (4) “Board” means the Maryland Board of Nursing. (5) “Delegating APRN” means an advanced practice registered nurse who directs an assistant to perform nursing and technical tasks. (6) “Direct supervision” means oversight exercised by a delegating APRN who is: (a) Personally treating the patient; and (b) In the physical presence of the patient and the assistant. (7) Mechanical Act. (a) “Mechanical act” means an act which does not require professional judgment, medical or pharmaceutical training, or discretion. (b) “Mechanical act” does not include: (i) Selecting a drug; (ii) Labeling; (iii) Measuring or calculating dosages; (iv) Substituting one drug for another, including substituting a generic or brand drug for the prescribed drug; (v) Substituting one dosage form of a drug for another; (vi) Altering the route of administration; or (vii) Counseling patients. (8) “On-site supervision” means oversight exercised by a delegating APRN who is present at the same site as the assistant and the patient and is: (a) Able to be immediately available in person during the assistant’s performance of a delegated act; (b) In the context of a synchronous telehealth interaction, able to be immediately available via secure telecommunications technology to the telehealth visit during the assistant’s performance of a delegated act; or (c) In the context of an asynchronous telehealth interaction, able to review the assistant’s work and interact with the assistant before communication with the patient. (9) “Site” means any facility or location, including those defined in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, used for the delivery of health care services. (10) “Synchronous telehealth interaction” has meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland. (11) “Technical task” means a routine clinical act or task that does not require clinical or nursing judgment and is performed with supervision as specified within this chapter. (12) “Trained” means possessing the knowledge, skills, and abilities, as determined by the delegating APRN, to perform delegated nursing and technical tasks. #### Regulation .03 Standards for Delegation. *COMAR 10.27.28.03* A. An APRN who delegates shall: (1) Assess the risk to the patient and the outcome of the delegated acts; (2) Delegate only those nursing and technical tasks that are customary to the practice of an APRN; (3) Delegate only those nursing and technical tasks for which the assistant has been trained; (4) Be responsible for the acts of the assistant; (5) Supervise the assistant in accordance with this chapter; and (6) If authorized to dispense prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland, perform a final check of the prescription medication before it is provided to the patient. B. The responsibility for the delegated act cannot be transferred from the delegating APRN to another APRN, or to another licensed health care provider that is authorized to delegate clinical and technical tasks, without: (1) The expressed consent of the other APRN or licensed health care provider; and (2) Informing the assistant. #### Regulation .04 Scope of Delegation to an Assistant. *COMAR 10.27.28.04* A. An APRN may not delegate nursing and technical tasks to an assistant which shall, by law or regulation, be performed only by an individual that is required to be licensed, certified, registered, or otherwise recognized pursuant to any State laws. B. An APRN may delegate nursing and technical tasks, consistent with national guidelines for nursing delegation established by the National Council of State Boards of Nursing and the approved policies and procedures of the site, in the following categories: (1) Surgical technical tasks that the delegating APRN directly orders while present and personally performing the surgery in the same surgical field; and (2) Nonsurgical technical tasks while the assistant is under the delegating APRN’s direct supervision or on-site supervision. C. Except as provided in §§B(1) and D of this regulation, an APRN shall provide at minimum on-site supervision when delegating nursing or technical tasks to an assistant, including, but not limited to, the following: (1) Patient preparation for physical examination; (2) Patient history interview; (3) Collecting and processing specimens, such as performing phlebotomy, inoculating culture media, pregnancy tests; dipstick and microscopic urinalysis, and microbiology including rapid streptococcal testing and throat cultures; (4) Preparing and performing laboratory tests that the APRN is satisfied the assistant is trained and qualified to perform under State and Clinical Laboratory Improvement Amendments regulations; (5) Clinical tests including, but not limited to: (a) Application of tuberculin skin tests; (b) Electrocardiography; (c) Administering basic pulmonary function tests; and (d) Visual field tests; (6) Transmitting prescriptions to a pharmacy; (7) Preparing and administering oral drugs; (8) Preparing and administering injections limited to intradermal, subcutaneous, and intramuscular within the deltoid, gluteal, or vastus lateralis muscles including small amounts of local anesthetics; (9) Establishing a peripheral intravenous line; and (10) Injecting fluorescein-like dyes for retinal angiography. D. When delegating injecting intravenous drugs or contrast materials to an assistant, an APRN shall provide direct supervision. E. An APRN who is authorized to dispense prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland may delegate only mechanical acts involved in dispensing a drug. F. An APRN may not delegate to an assistant any act that requires the exercise of clinical judgment by an APRN, including, but not limited to: (1) Conducting physical examinations; (2) Administering any form of anesthetic agent or agent of conscious sedation other than topical anesthetics or small amounts of local anesthetics; (3) Initiating independently any form of treatment, except for cardiopulmonary resuscitation or other forms of emergency treatment authorized to be performed by non-clinicians under State law; (4) Establishing a diagnosis or giving clinical advice; and (5) Providing physical therapy. #### Regulation .05 Prohibited Conduct and Penalties. *COMAR 10.27.28.05* A. An assistant acting beyond the scope of this chapter may be: (1) Considered to be engaged in the unlicensed practice of nursing, advanced practice registered nursing, or any other health occupation recognized by the State; and (2) Subject to all applicable fines and penalties in accordance with Health Occupations Article, §§8-701—8-711, Annotated Code of Maryland and applicable regulations, or any other applicable provision of Health Occupations Article, Annotated Code of Maryland. B. A delegating APRN, through either act or omission, facilitation, or otherwise enabling or forcing an assistant to practice beyond the scope of this chapter, may be subject to discipline as set forth in Health Occupations Article, §8-316, Annotated Code of Maryland. C. A delegating APRN may not: (1) Require an assistant to perform a delegated nursing or technical task; or (2) Permit an assistant to delegate any act to another individual. #### Regulation .06 Enforcement. *COMAR 10.27.28.06* The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, Title 8, Annotated Code of Maryland and this chapter, and it may refer any complaint or investigation to any other appropriate licensing or regulatory authority in accordance with applicable laws and regulations. ## Subtitle 28 — Board of Examiners in Optometry ### Chapter 01 — Telehealth **Authority:** Health Occupations Article, §§1-1001—1-1006, Annotated Code of Maryland **Administrative History:** Effective date: September 18, 2023 (50:18 Md. R. 794) #### Regulation .01 Scope. *COMAR 10.28.01.01* A. This chapter governs the practice of optometry using telehealth as an adjunct to, or replacement for, in-person patient visits. B. Nothing in this chapter restricts or limits reimbursement requirements pursuant to Health-General Article and Insurance Article, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.28.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Asynchronous” means not occurring in real time. (2) “In-person” means within the physical presence of the patient. (3) “Interpretive services” means reading and analyzing images, tracings, or specimens through telehealth or giving interpretations based on visual, auditory, thermal, or ultrasonic patterns or other patterns as may evolve with technology. (4) “Synchronous” means occurring in real time. (5) “Telehealth” has the meaning stated in Health Occupations Article, §1-1001, Annotated Code of Maryland. (6) “Telehealth practitioner” means a Maryland licensed optometrist performing telehealth services within the scope of practice. #### Regulation .03 Licensure. *COMAR 10.28.01.03* Subject to the provisions of Health Occupations Article, §11-301, Annotated Code of Maryland, a telehealth practitioner shall be licensed in Maryland when providing telehealth services to a patient located in the State. #### Regulation .04 Standards of Practice for Telehealth. *COMAR 10.28.01.04* A. Before performing telehealth services, a telehealth practitioner shall develop and follow a procedure to: (1) Verify the identification of the patient receiving telehealth services through the use of: (a) A government-issued photograph identification; (b) An insurance, Medicaid, or Medicare card; or (c) Documentation of the patient’s: (i) Date of birth; and (ii) Home address; (2) For an initial patient-telehealth practitioner encounter, disclose the telehealth practitioner’s (a) Name; (b) Contact information; (c) Maryland license number; and (d) Medical specialty, if applicable; (3) Except for interpretive services, obtain oral or written consent from a patient or patient’s parent or guardian if State law requires the consent of a parent or guardian, including informing patients of the risks, benefits, and side effects of prescribed treatments; (4) Securely collect and transmit a patient’s medical information, clinical data, clinical images, laboratory results, and self-reported medical history, as necessary, and prevent access to data by unauthorized persons through encryption or other means; (5) Notify patients in the event of a data breach; (6) Ensure that the telehealth practitioner provides a secure and private communication modality that complies with federal and state privacy laws; and (7) Establish safety protocols to be used in the case of an emergency. B. Except when providing asynchronous telehealth services, a telehealth practitioner shall: (1) Obtain or confirm an alternative method of contacting the patient in case of a technological failure; (2) Confirm whether the patient is in Maryland and identify the practice setting in which the patient is located; and (3) Identify all individuals present at each location and confirm they are allowed to hear personal health information. C. A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable for in-person health care settings. D. The requirements set forth under §§A and B of this regulation may be delegated. #### Regulation .05 Patient Evaluation. *COMAR 10.28.01.05* A. Subject to the provisions of Health Occupations Article, §11-208, Annotated Code of Maryland, a telehealth practitioner shall: (1) Perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing treatment or issuing a prescription through telehealth; and (2) If clinically appropriate for the patient, provide or refer a patient to: (a) In-person health care services; or (b) Another type of telehealth service. B. A telehealth practitioner may not treat a patient or issue a prescription based solely on a static online questionnaire. #### Regulation .06 Telehealth Practitioner Discipline. *COMAR 10.28.01.06* A. The Board shall use the same standards of evaluating and investigating a complaint about and in disciplining a licensee who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice. B. The failure of a telehealth practitioner to comply with Regulations .04 and .05 of this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board. ### Chapter 02 — Continuing Education Requirements **Authority:** §§1-225, 11-101, 11-205, 11-308(c), and 11-309, Annotated Code of Maryland **Administrative History:** Effective date: September 9, 1974 **Administrative History:** Regulation .04 amended effective June 6, 1983 (10:11 Md. R. 975) **Administrative History:** Regulation .04F adopted effective December 3, 1984 (11:24 Md. R. 2069) **Administrative History:** Chapter revised effective April 8, 1996 (23:7 Md. R. 552) **Administrative History:** Regulation .02 amended effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488); July 7, 2025 (52:13 Md. R. 656) **Administrative History:** Regulation ,03 amended effective July 7, 2025 (52:13 Md. R. 656) **Administrative History:** Regulation .04 amended effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .04A amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .05 amended effective March 26, 2007 (34:6 Md. R. 627); October 19, 2009 (36:21 Md. R. 1591); October 1, 2012 (39:19 Md. R. 1237); May 20, 2019 (46:10 Md. R. 488); July 7, 2025 (52:13 Md. R. 656) **Administrative History:** Regulation .05B amended effective April 16, 2012 (39:7 Md. R. 493) **Administrative History:** Regulation .05J adopted effective April 16, 2012 (39:7 Md. R. 493) **Administrative History:** Regulation .06B, C amended effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulation .07 amended effective May 20, 2019 (46:10 Md. R. 488) #### Regulation .01 Scope. *COMAR 10.28.02.01* This regulation governs all optometrists licensed to practice in the State of Maryland. #### Regulation .02 Definitions. *COMAR 10.28.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited” means continuing education activities produced and delivered by: (a) COPE administrators in compliance with COPE accreditation criteria, standards for commercial support, and policies and procedures; or (b) Non-COPE administrators in compliance with a program accepted as substantially equivalent to the Accreditation Council for Continuing Medical Education (ACCME) accreditation system. (2) “Council on Optometric Practitioner Education (COPE)” means the program of the Association of Regulatory Boards of Optometry, which accredits continuing education courses and activities accepted as substantially equivalent to the Accreditation Council for Continuing Medical Education (ACCME) accreditation system for optometrists. (3) “Credit hour” means the increment of educational instruction time. (4) “Diagnostic Pharmaceutical Agents (DPA) certified optometrist” means a licensed optometrist who has fulfilled the requirements of the Board and is certified by the Board to use diagnostic pharmaceutical agents in the practice of optometry and provides diagnostic services to patients in Maryland. (5) “Pro bono work” means work provided in Maryland within the scope of practice of the licensee without financial reimbursement or direct financial gain. (6) “Therapeutic Pharmaceutical Agents (TPA) certified optometrist” means a licensed optometrist who has fulfilled the requirements of the Board and is certified by the Board to use therapeutic pharmaceutical agents in the practice of optometry and provides therapeutic services to patients in Maryland. #### Regulation .03 Registration Renewal. *COMAR 10.28.02.03* A. A licensee shall submit a signed form attesting to the licensee's completion of the required credit hours at the time of license renewal. B. First-Time Renewal Requirements. Licensees eligible for renewal: (1) From another state licensed for less than 2 years, may earn credit hours which may be prorated for first-time renewal based on the license issuance date; (2) That did not apply within a year of graduation and has been licensed for less than 2 years, may earn credit hours which may be prorated for first-time renewal based on the license issuance date; (3) That have applied for renewal within 1 year of graduation from an accredited school or college of optometry may have continuing education requirements waived by the Board; and (4) Are required to complete Implicit Bias Training and CPR certification. C. A licensee shall retain supporting documents for inspection by the Board for 4 years after the date of renewal. D. If a licensee submits the renewal form after the deadline, the Board shall: (1) Assess a late fee; and (2) Audit the licensee. E. Failure to meet continuing education requirements or failure to substantiate credit hours submitted upon request of the Board may result in suspension, revocation, or denial of licensure. #### Regulation .04 Continuing Education Audit Procedure. *COMAR 10.28.02.04* A. At the time of renewal, the Board shall audit a minimum of 20 percent of the renewal applications. B. The Board shall send notification of audit to licensees to be audited. C. The licensee being audited shall submit to the Board, within 60 days, a report of the continuing education hours required for renewal on a form approved by the Board, along with the appropriate documentation. #### Regulation .05 Required Credit and Other Course Credit. *COMAR 10.28.02.05* A. Credit for continuing professional education shall be: (1) Accredited; or (2) Approved by the Board solely on whether or not it constitutes improvement, advancement, and extension of one’s professional skill and knowledge relating to the practice of optometry. B. General Requirements. (1) TPA certified optometrists shall: (a) Document 50 hours of continuing professional education every 2 years, with 30 of the 50 hours focused on therapeutic topics; and (b) Provide proof of CPR certification every renewal which may count as 3 credit hours. (2) DPA certified optometrists shall: (a) Document 36 hours of continuing professional education, every 2 years, with 6 of the 36 hours focused on diagnostic pharmaceuticals; and (b) Provide proof of CPR certification every renewal which may count as 3 credit hours. (3) Non-Certified licensed optometrists shall: (a) Document 36 hours of continuing professional education every 2 years; and (b) Provide proof of CPR certification every renewal which may count as 3 credit hours. (4) The Board accepts: (a) Only accredited or Board-approved continuing education programs; and (b) Therapeutic courses that fall within the Ocular Disease and related Systemic Disease categories. C. Trainings. (1) Except for those identified in §I of this regulation, an optometrist who is issued a license by the Board may complete continuing professional education by attending in-person, virtual synchronous, or asynchronous trainings with post-test assessments conducted by an accredited administrator. The trainings may include: (a) Courses given by: (i) The Maryland Optometric Association; (ii) Another Statewide association; or (iii) Any organization approved by the Board, solely on whether or not it constitutes improvement, advancement, and extension of one’s professional skill and knowledge relating to the practice of optometry. (b) Observation of ophthalmic procedures at sites approved by the Board; or (c) Other continuing professional education activities given by: (i) The Maryland Optometric Association; (ii) Another Statewide association; or (iii) A nonprofit organization approved by the Board. (2) If requested pursuant to Regulation .04 of this chapter, an optometrist shall provide to the Board a certificate of attendance or other method of verifying attendance at an event conducted by an accredited event administrator. (3) In accordance with §A of this regulation, events conducted by an accredited event administrator shall have Board approval. D. Other than those required in §C of this regulation, credit hours may be approved for the following: (1) Scheduled post-graduate or continuing education courses given by schools or colleges of optometry which have been approved by the Board; (2) Courses, either in-person, online, or both, that have received accreditation; however, the Board reserves the right to refuse credit when its established criteria are not met; (3) Courses, either in-person, online, or both, on Practice Management directly related to optometric care, up to a maximum of 4 hours per renewal cycle; (4) Courses given by local optometric societies or health-related sponsors, or both, upon prior approval by the Board. (5) Courses, seminars, and lectures prepared and given by Maryland licensed optometrists for which credit will be awarded at the rate of 2 hours for preparation and 1 hour for lecture, up to a maximum of 24 hours per renewal cycle; (6) Published papers in professional journals, papers approved for publication, or papers that have been peer-reviewed for which credit will be awarded at 2 hours per paper, up to a maximum of 12 hours per renewal cycle; (7) Observation of ophthalmic procedures at sites approved by the Board, up to a maximum of 8 hours per renewal cycle; (8) Courses, either in-person, online, or both, in optometric ethics, Maryland optometric jurisprudence, or both, as approved by the Board, up to a maximum of 4 hours per renewal cycle; (9) Pro bono work providing patient eye care as outlined in §J of this regulation; (10) Public board meeting attendance as outlined in §K of this regulation; (11) Courses, either in-person or online, and certification in cardiopulmonary resuscitation (CPR) up to a maximum of 3 hours per renewal cycle; and (12) Courses in cultural competency, up to a maximum of 4 hours per renewal cycle. E. Credit hours will be allowed on the basis of 50 minutes being equivalent to an hour, except for pro bono work. Fractional credit hours are allowed. F. Unless Board or COPE approved, credit may not be allowed when a specific product, technique, procedure, or company is promoted or promulgated for the economic benefit of a particular person, company, group, etc. G. Unless there are extenuating circumstances, credit is allowed only in and for the license year in which the course was actually attended. H. The determination of whether or not a course meets these standards shall be entirely within the Board's province. The Board shall also determine whether or not credit for an entire course, or any lesser number of hours, may be granted. I. The Board may waive continuing education requirements for, but not limited to, licensees who: (1) Have applied for licensure within 1 year of graduation from an accredited school or college of optometry; and (2) Are renewing their license for the first time. J. Pro Bono Work. (1) Pro bono work shall earn 2 credit hours for each 3 hours of approved continuing education activity, up to a maximum of 12 credit hours per renewal cycle. (2) The licensee shall provide to the Board a written application for approval of pro bono work. The application shall include: (a) The place where the pro bono will be provided; (b) The type of work to be provided; (c) The number of hours of actual work provided for which the licensee desires credit hours; and (d) A statement guaranteeing that the work provided no financial benefit to the licensee. (3) Upon completion of the work, the licensee shall obtain from the facility evidence of completion of pro bono hours. (4) Credit hours for pro bono work are in the general category. K. Public Board Meeting Attendance. (1) Licensees may receive 2 credit hours for attending in its entirety an open session meeting of the Board of Examiners in Optometry. (2) The Board shall issue to the licensee a certificate of proof of attendance. (3) A licensee may not earn more than 4 credit hours in this area per renewal cycle. #### Regulation .06 Proof of Education. *COMAR 10.28.02.06* A. Each optometrist is responsible for obtaining proof of hour credits and maintaining this documentation for inspection by the Board for 4 years after the date of renewal. B. To obtain credit, one's participation shall be attested to in writing by someone in charge of the program. C. Failure to do so shall be grounds for nonrenewal of the license. #### Regulation .07 Change of Annual Requirements of Number of Hours. *COMAR 10.28.02.07* The Board, by majority vote, may change the number of required hours of continuing education, subject to the requirements in Health Occupations Article, §11-309, Annotated Code of Maryland. An optometrist shall be notified of any change at the time of the renewal of the optometrist’s license. The change is effective for the year following that renewal. #### Regulation .08 Severability. *COMAR 10.28.02.08* If any provision of these regulations or the application thereof to any person or circumstances is held invalid, this invalidity may not affect other provisions or applications of these regulations which can be given effect without the invalid provision or application, and to this end, the provisions of these regulations are declared severable. ### Chapter 03 — Examination and Licensing of Optometrists **Authority:** Health Occupations Article, §§11-205 and 11-302—11-308, Annotated Code of Maryland **Administrative History:** Effective date: March 21, 1980 (7:6 Md. R. 608) **Administrative History:** Regulation .03B amended effective January 22, 1990 (17:1 Md. R. 70) **Administrative History:** Regulation .04 amended effective February 13, 1984 (11:3 Md. R. 202); January 22, 1990 (17:1 Md. R. 70) **Administrative History:** Regulation .05 amended effective January 22, 1990 (17:1 Md. R. 70) **Administrative History:** Regulation .06 amended effective February 13, 1984 (11:3 Md. R. 202); January 22, 1990 (17:1 Md. R. 70) **Administrative History:** Regulation .07 amended effective January 22, 1990 (17:1 Md. R. 70) **Administrative History:** Regulation .09A, D amended effective January 22, 1990 (17:1 Md. R. 70) **Administrative History:** Chapter revised effective November 7, 1994 (21:22 Md. R. 1876) **Administrative History:** Chapter revised effective February 19, 2001 (28:3 Md. R. 206) **Administrative History:** Regulation .02B, C amended effective July 31, 2017 (44:15 Md. R. 760) **Administrative History:** Regulation .04 repealed effective March 31, 2003 (30:6 Md. R. 420) **Administrative History:** Regulation .08 amended effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Chapter revised effective July 7, 2025 (52:13 Md. R. 656) #### Regulation .01 Definition. *COMAR 10.28.03.01* “Board” means the Board of Examiners in Optometry. #### Regulation .02 Requirements for Licensure. *COMAR 10.28.03.02* A. Preprofessional education—completion of 2 years of pre-optometric college study in an accredited institution of higher learning or its equivalent. B. Professional education — completion of 4 scholastic years at: (1) An accredited college of optometry; (2) An accredited university school of optometry; or (3) An equivalent of §B(1) or (2) of this regulation. C. The Board will accept applications for examination from graduates of those colleges of optometry or university schools of optometry: (1) Endorsed by the Association of Regulatory Boards of Optometry (ARBO); and (2) Accredited by the Council on Optometric Education of the American Optometric Association. #### Regulation .03 Application for Licensure. *COMAR 10.28.03.03* A. An applicant shall complete and file an application on the form provided by the Board on request. B. The applicant shall submit the following information: (1) Full name, residence, and date and place of birth; (2) A recent photograph of the applicant; (3) Letters of recommendation from three individuals, excluding immediate family members, who can attest to the applicant's character and reputation; (4) All final professional transcripts of colleges or university schools of optometry; (5) The application fee specified in COMAR 10.28.07; (6) Satisfactory evidence of having completed a criminal history records check in accordance with Health Occupations Article, §11-302.1, Annotated Code of Maryland; and (7) Preprofessional transcripts. C. Application fees are not refundable. D. Applicants shall be notified whether they meet the standards adopted by the Board and qualify for licensure. #### Regulation .04 Examination. *COMAR 10.28.03.04* A. The Board shall require candidates for licensure to take and pass the National Board of Examiners in Optometry’s (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections. B. A candidate for licensure shall obtain a minimum score of 75 percent on the Maryland Board of Examiners in Optometry jurisprudence examination. #### Regulation .05 Waiver of Examination. *COMAR 10.28.03.05* Standards for licensure with partial waiver of examination are set forth in Health Occupations Article, §11-305, Annotated Code of Maryland. #### Regulation .06 License Renewal. *COMAR 10.28.03.06* A. The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. B. A licensee shall renew the license every 2 years, on or before July 1 of the renewal year. C. The Board shall send each licensee a renewal notice that states the: (1) Date on which the current license expires; (2) Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license to be issued before the current license expires; and (3) Amount of the renewal fee as specified in COMAR 10.28.07.02. D. At least 30 days before the current license or registration expires, the Board shall send the renewal notice by electronic means or first-class mail to the last known electronic or physical address of the licensee. E. The failure to receive a renewal notice does not excuse a licensee from complying with §B of this regulation. F. Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.28.02. G. After the expiration date of the license, the optometrist is no longer licensed to practice optometry in the State. #### Regulation .07 Change of Mailing Address, Legal Name, or Email Address. *COMAR 10.28.03.07* A. A licensed optometrist shall give the Board written notice within 30 days of a change of: (1) Mailing address; (2) Legal name; or (3) Email address if the licensee has previously submitted an email address to the Board. B. Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a $50 fee as set forth under COMAR 10.28.07.02. ### Chapter 04 — Rules of Procedure for Board Hearings **Authority:** Health Occupations Article, §§11-205, 11-313, and 11-315;State Government Article, §10-206; Annotated Code of Maryland **Administrative History:** Effective date: April 11, 1983 (10:7 Md. R. 634) **Administrative History:** Regulations .01 — .09 repealed and new Regulations .01 — .12 adopted effective September 3, 2001 (28:17 Md. R. 1556) #### Regulation .01 Scope. *COMAR 10.28.04.01* This chapter governs procedures for disciplinary matters and hearings before the State Board of Examiners in Optometry. #### Regulation .02 Definitions. *COMAR 10.28.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative law judge” means the hearing officer assigned to preside over a hearing in cases which the Board has delegated to the Office of Administrative Hearings. (2) “Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges brought by the Board. (3) “Administrative prosecutor” means the attorney assigned by the Office of the Attorney General to prosecute disciplinary charges for the Board. (4) “Board” means the State Board of Examiners in Optometry. (5) “Case resolution conference” means an informal, confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board. (6) “Case resolution conference committee” means a committee composed of one or more members of the Board who make recommendations to the Board regarding settlement of disciplinary matters. (7) “Cease and desist letter” means an informal action consisting of a nonpublic letter issued by the Board ordering: (a) A licensee to cease doing a specified activity; or (b) An unlicensed individual to cease the unauthorized practice of optometry. (8) “Charging document” means a nonpublic record issued by the Board which: (a) Alleges conduct by a licensee which the Board believes constitutes a violation under the Maryland Optometry Act; (b) Sets forth sections of the Maryland Optometry Act that the Board believes were violated; and (c) Provides notice to the licensee of disciplinary proceedings before the Board. (9) “Complaint” means a written allegation received by the Board that a licensee may have violated the Maryland Optometry Act and which may be grounds for an investigation or disciplinary action by the Board. (10) “Consent order” means a public record issued by the Board which is a final order of the Board that has been negotiated and agreed to by both the licensee and the Board to resolve a disciplinary matter. (11) “Contested case” means a proceeding conducted pursuant to the Administrative Procedure Act. (12) “Disposition agreement” means a formal nonpublic agreement, entered into with an impaired licensee in lieu of formal disciplinary action, where the licensee agrees to comply with certain conditions. (13) “Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which: (a) Denies a license; (b) Sanctions by reprimand, probation, fine, or suspension or revocation of a license; (c) Summarily suspends a license; (d) Dismisses charges; (e) Surrenders a license; or (f) Takes any other action that the Board is authorized to do by law. (14) “Imperatively requires emergency action” means a finding by the Board that an emergency action be taken against a licensee pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, based on investigative facts that raise a substantial likelihood of risk of harm to the public health, safety, or welfare before a full evidentiary hearing can be held. (15) “Informal action” means that the Board closes a case, without taking any formal disciplinary action or issuing a final order, by imposing a disciplinary sanction consisting of a: (a) Letter of education; (b) Letter of admonishment; (c) Cease and desist letter; or (d) Consent agreement. (16) “Investigation” means the gathering of information to assist the Board in determining whether there is reasonable cause to charge a licensee with a violation of the Maryland Optometry Act. (17) Letter of Admonishment. (a) “Letter of admonishment” means informal action consisting of a nonpublic letter issued by the Board closing the case, when the Board believes a licensee has engaged in conduct which violates the Maryland Optometry Act. (b) “Letter of admonishment” includes admonishment of the licensee not to repeat the actions. (c) “Letter of admonishment” may include an agreement that a licensee perform certain conditions in lieu of the Board taking formal disciplinary action. (18) “Letter of education” means informal action consisting of a nonpublic letter: (a) Issued by the Board when the Board does not believe that conduct rose to the level of a violation of the Maryland Optometry Act; and (b) In which the Board educates the licensee concerning the laws and standards of the practice of optometry. (19) “Letter of surrender” means a public letter accepted by the Board in which the licensee agrees to surrender the licensee's license to practice optometry, which may include conditions for the Board's acceptance of the surrender as a resolution of the case. (20) “Licensure” means permission to engage in a health care profession regulated by the Board, which is in any form including a certificate, registration, or license. (21) “Maryland Optometry Act” means Health Occupations Article, Title 11, Annotated Code of Maryland. (22) “Notice of initial denial” means a nonpublic record issued by the Board by which an applicant or licensee is notified that the Board intends to deny a license, change in licensure status, or some other benefit sought by the licensee. (23) “Penalty” means a monetary or administrative penalty imposed pursuant to Health Occupations Article, §11-314, Annotated Code of Maryland. (24) “Post-deprivation hearing” means a contested case hearing scheduled by the Board after the Board has issued an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the licensee may challenge the Board's basis for issuing the order for summary suspension. (25) “Predeprivation hearing” means a non-evidentiary, show cause hearing held before the Board at which the licensee has an opportunity to demonstrate to the Board why it should not: (a) Issue an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland; or (b) Take some other action which the Board is authorized by law to take. (26) “Preliminary investigation” means the gathering of information to be used by the Board to determine whether the Board should dismiss a complaint or conduct further investigation to determine if there is reasonable cause to charge a licensee with a violation of the Maryland Optometry Act. (27) “Probation” means a sanction imposed by the Board in a public final order where the licensee is: (a) Monitored by the Board for a period of time; and (b) Required to comply with certain conditions in order to avoid further disciplinary action. (28) “Prohibited act” means any conduct specified in the Maryland Optometry Act which can result in sanctions or penalties. (29) “Public record” means a document that the Board is permitted or required to disclose to the public pursuant to the State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland. (30) “Recommended decision” means a nonpublic record issued to the Board by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, and a proposed sanction, or any combination of these actions. (31) “Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason which may interfere with the Board member's participation in a case. (32) “Respondent” means a licensee, subject to the jurisdiction of the Board, who has been: (a) Given notice to answer allegations concerning violations of the Maryland Optometry Act; (b) Notified as to a potential emergency suspension pursuant to State Government Article, §10-226(c), Annotated Code of Maryland; or (c) Notified as to a potential violation of Health Occupations Article, §11-501, Annotated Code of Maryland. (33) “Revocation” means the removal of an optometrist's license to practice optometry. (34) “Sanction” means an action by the Board which: (a) Reprimands; (b) Places on probation; (c) Fines; (d) Suspends or revokes a license; or (e) Disciplines by a consent order. (35) “Show cause hearing” means a non-evidentiary hearing held before the Board in which the licensee has the opportunity to demonstrate to the Board why the Board should not issue a proposed order or take an action that the Board is legally authorized to take. (36) “Stay” means the withholding of an action ordered by the Board which may be subject to certain conditions. (37) “Summary suspension” means the indefinite suspension of a license pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, where the Board believes that the action is necessary to protect the public health, safety, or welfare. (38) “Surrender” means the voluntary relinquishing of a license to practice optometry which may be subject to certain conditions set by the Board. (39) “Suspension” means a temporary denial of the right to use a license and is usually defined by: (a) A specific period of time; (b) Specific dates; or (c) Specific conditions. #### Regulation .03 Confidentiality of Proceedings. *COMAR 10.28.04.03* A. Except as otherwise provided by law, the proceedings of the Board are confidential and that confidentiality may not be waived by the parties. B. The Office of Administrative Hearings' proceedings involving the adjudication of a Board contested case and the administrative law judge's recommended decision are confidential and the respondent may not waive the confidentiality of the proceedings or of the patients whose medical records or care are reflected in the record of the proceedings. C. To the extent possible, even after a final order is entered into by the Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referred to in the Board's order. #### Regulation .04 Representation by Counsel. *COMAR 10.28.04.04* A. A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings. B. If the matter goes to a hearing, the respondent shall be represented in proper person or by an attorney who has been: (1) Admitted to the Maryland Bar; or (2) Specially admitted to practice law pursuant to Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland. C. The Board may be represented by and obtain advice of counsel assigned to it by the Office of the Attorney General in all proceedings. #### Regulation .05 Proceedings under Health Occupations Article, §11-313, Annotated Code of Maryland. *COMAR 10.28.04.05* A. Investigation of Complaints. (1) The Board may: (a) Make a preliminary review of each complaint; and (b) Recommend that cases involving complaints over which the Board has no jurisdiction be closed. (2) The Board may send a copy of the complaint, either in its entirety or redacted, to the licensee who is the subject of the complaint to obtain a response to the allegations made in the complaint. (3) Board subpoenas may be issued by the Board over the signature of the administrator. B. Prosecution of Complaint. (1) For each complaint, after reviewing any completed investigative information or reports, the Board shall: (a) Dismiss the complaint; (b) Close the case with informal action; (c) Issue a cease and desist order; (d) Refer the matter for further investigation; (e) Refer the matter to an administrative prosecutor; or (f) Vote to: (i) Charge a licensee with a violation of Health Occupations Article, §11-313, Annotated Code of Maryland; (ii) Consider the matter as a basis for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland; (iii) Initially deny licensure or reinstatement of a license; or (iv) Accept the surrender of a license subject to conditions acceptable to the Board. (2) The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, whether or not it has voted to charge a licensee with violations of the Maryland Optometry Act. C. Charges and Notice of Initial Denial. (1) If the Board issues charges or a notice of initial denial, the document shall be: (a) Served upon the respondent by certified mail at the address the respondent is required to maintain with the Board; or (b) Hand delivered in person. (2) Charges or a notice of initial denial shall: (a) Inform the respondent of the statutory basis for the charges or denial of licensure; (b) Allege sufficient facts which the Board believes constitute either a basis for: (i) Violation of the Maryland Optometry Act; or (ii) Denial of licensure; (c) Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing; and (d) Be accompanied by a letter of procedure notifying respondent of the applicability of the Administrative Procedure Act to the Board's proceedings. (3) If the Board is unable to serve the charges or notice of initial denial upon the respondent as described in §C(1) of this regulation or attempt any other reasonable means to effect service, the Board may nevertheless proceed in prosecuting the case. (4) If the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board. D. Discovery. (1) Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following: (a) A list of the witnesses to be called; (b) Copies of all documents intended to be produced at the hearing; or (c) Both §D(1)(a) and (b) of this regulation. (2) Mandatory Discovery. (a) Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier: (i) The name and curriculum vitae of any expert witness who will testify at the hearing; and (ii) A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion. (b) If the Board, or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert. (c) The Board, or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report: (i) At the prehearing conference, if scheduled; or (ii) Immediately before the scheduled hearing. (d) If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section. (3) Parties are not entitled to discovery of items other than those listed in §D(1) and (2) of this regulation. (4) Both parties have a continuing duty to supplement their disclosures of witnesses and documents. (5) Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list: (a) After the prehearing conference, if scheduled; or (b) Later than 15 days before the hearing, if no prehearing conference is scheduled. (6) The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes. (7) Construction. (a) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall be construed, whenever possible, as supplementing and in harmony with COMAR 28.02.01. (b) In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies. E. Case Resolution Conference. (1) After service of charges or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference. (2) At any other time during disciplinary proceedings, the Board may offer or the respondent may request a case resolution conference to discuss a disciplinary matter. (3) The Board may deny a respondent's request for a case resolution conference except as provided in §E(1) of this regulation. (4) Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in any subsequent proceedings, unless the information is otherwise discovered or available through another source. (5) The Board is not bound by the recommendations of the case resolution conference committee and may: (a) Modify a proposed settlement; (b) Require additional conditions; or (c) Reject the recommendation and require the respondent to proceed to a hearing. (6) If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is recommended by the case resolution conference committee and ratified by the Board, the matter shall proceed to a hearing on the charges or on a notice of initial denial. (7) If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing in the matter, regardless of whether or not the Board has ratified the recommendation of the case resolution conference committee. (8) Participation in a case resolution conference is not ordinarily a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case. #### Regulation .06 Proceedings under Health Occupations Article, §11-313, Annotated Code of Maryland — Sanctions, Hearings, and Final Order. *COMAR 10.28.04.06* A. Surrender of License. (1) The Board may require conditions for surrender of a license, including, but not limited to: (a) The admission of a violation of the Maryland Optometry Act; (b) The admission of facts; (c) A statement of the circumstances under which the surrender was offered or accepted; (d) Restrictions on future licensure; (e) Conditions for reinstatement of the license; or (f) An agreement that the respondent may not again apply for reinstatement of the license. (2) A letter of surrender is a final order of the Board and is a public record pursuant to State Government Article, §10-611, Annotated Code of Maryland, unless the Board determines that disclosure of the surrender is not in the public interest. B. Hearings on Charges or Notice of Initial Denial. (1) Hearings shall be conducted pursuant to State Government Article, Title 10, Annotated Code of Maryland. (2) The Board may delegate its authority to hear contested cases to the Office of Administrative Hearings. (3) Proceedings are not open to the public and all records, including the recommended decision, shall be treated as confidential and sealed. (4) If a matter has been delegated to the Office of Administrative Hearings, the administrative law judge presiding over the proceedings shall issue to the Board a recommended decision containing: (a) Proposed or final findings of fact; (b) Proposed or final conclusions of law; (c) A proposed sanction; or (d) Any combination of §B(4)(a) — (c) of this regulation pursuant to the Board's delegation. C. Burden of Proof. (1) A licensee against whom the Board has issued a notice of initial denial has the burden to demonstrate by a preponderance of the evidence that the licensee is entitled to licensure or to receive the benefit sought which the Board has initially denied. (2) The Board has the burden to demonstrate by a preponderance of the evidence that the licensee has committed a violation or violations of the Maryland Optometry Act. D. Exceptions and Exceptions Hearing. (1) If a matter has been delegated by the Board to the Office of Administrative Hearings, a party may file exceptions to the administrative law judge's proposed findings of fact, proposed conclusions of law, and proposed sanction, as set out in the recommended decision, before the Board makes a final decision. (2) Within 15 days after the issuance of the recommended decision, or as otherwise specified by the administrative law judge in the recommended decision, either party may file written exceptions with the Board. (3) Unless otherwise permitted by the Board, a party's written exceptions may not be longer than 25 double-spaced pages. The exceptions shall state with particularity: (a) The finding of fact, conclusion of law, or other matter excepted to; and (b) The relevant portions of the record supporting the party's exception. (4) Within 10 days after a party's exceptions are filed with the Board, the opposing party may file an answer to exceptions. (5) Unless otherwise permitted by the Board, a party's answer to exceptions may not be longer than 25 double-spaced pages. The answer shall state with particularity a response to an exception and the relevant portions of the record supporting that response. (6) Unless otherwise permitted, the Board may not consider a party's response to an answer to exceptions. (7) Unless otherwise agreed by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board following receipt of the parties' exceptions and any answer to exceptions. (8) Exceptions Hearing. (a) An exceptions hearing shall be held before the Board. (b) The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions. (c) The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument. (d) The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient progress of the hearing. (e) The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal. (9) Unless otherwise agreed by the parties and permitted by the Board, the parties may not, in any answer to exceptions, or in the hearing on exceptions, reference any document or other evidence or offer any exhibit that is outside the record of the evidentiary hearing before the administrative law judge. (10) If neither party files exceptions within the time specified in §D(2) of this regulation, the Board shall consider only the recommended decision of the administrative law judge and the record of the evidentiary hearing in making its final decision. E. Board Final Decision and Order. (1) After review of the record and deliberation, the Board shall issue a final order consisting of findings of fact, conclusions of law, and the sanction or disposition to be imposed. (2) Upon a finding that there has been a violation of the Maryland Optometry Act, the Board may order that the licensee be fined, reprimanded, or placed on probation, or that the license be suspended or revoked. #### Regulation .07 Summary Suspension of a License. *COMAR 10.28.04.07* A. Pursuant to its authority under State Government Article, §10-226(c)(2), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that there is a substantial likelihood that a licensee poses a risk of harm to the public health, safety, or welfare. B. Notice of Intent to Summarily Suspend. (1) Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue: (a) A notice of an intent to summarily suspend a license; or (b) An order of summary suspension. (2) If the Board votes to issue a notice of an intent to summarily suspend a license or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution. (3) A notice of intent to summarily suspend a license shall include, but is not limited to: (a) A proposed order of summary suspension which is unexecuted by the Board and which includes: (i) The statutory authority on which the action has been taken; (ii) Allegations of fact which the Board believes demonstrate a substantial likelihood that the licensee poses a risk of harm to the public health, safety, or welfare; and (iii) Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and (b) An order or summons to appear before the Board: (i) To show cause why the Board should not execute the order of summary suspension; and (ii) Which notifies the respondent of the consequences of failing to appear. (4) Service. (a) The Board shall serve a respondent with a notice of intent to summarily suspend a license not later than 5 days before a predeprivation show cause hearing is scheduled before the Board. (b) Service of the notice of intent to summarily suspend shall be made: (i) Personally upon the respondent; (ii) By certified mail to the address the respondent is required to maintain with the Board; or (iii) By any other reasonable means to effect service. (c) If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed in prosecuting the case. C. Predeprivation Opportunity to Be Heard. (1) If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's license should not be suspended before the Board executes the order of summary suspension. (2) Predeprivation Show Cause Hearing Before the Board. (a) The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension. (b) The Board member presiding over the hearing shall determine all procedural issues and may impose reasonable time limits on each party's oral argument. (c) The presiding Board member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing. (d) The respondent and the administrative prosecutor shall each be limited to 30 minutes in which to present oral argument. (e) The respondent shall proceed first and may reserve part of the allotted time for rebuttal. (3) The Board member who presides over the hearing: (a) May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious when the presiding Board member believes that the documents or exhibits are necessary in order for a fair hearing; and (b) May not allow testimony by any witness unless agreed to by the parties and approved by the Board in advance of the hearing. (4) The members of the Board may be recognized by the presiding member to ask questions of either party appearing before the Board. D. Summary Suspension of a License Without Prior Notice or an Opportunity To Be Heard. (1) In extraordinary circumstances, the Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend the license or providing a respondent with an opportunity for a predeprivation hearing if: (a) The Board determines that the public health, safety, and welfare requires the immediate suspension of the license and that prior notice and an opportunity to be heard is not feasible; (b) The order of summary suspension is served upon the respondent within 24 hours after its execution; and (c) The respondent is provided with an opportunity for a hearing before the Board within 15 days after the effective date of the summary suspension. (2) If the respondent requests a hearing pursuant to §D(1)(c) of this regulation, that hearing shall be conducted before the Board as provided in §C(2) of this regulation and shall provide the respondent with an opportunity to show cause why the Board should lift the summary suspension and reinstate the license. E. Burdens of Production and Persuasion. (1) In a show cause proceeding pursuant to §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare is not at risk. (2) The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent's license. F. Disposition. (1) If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to: (a) Order a summary suspension; (b) Deny the summary suspension; (c) Enter into an order agreed upon by the parties; or (d) Enter into any interim order warranted by the circumstances of the case, including one providing for stay of the summary suspension subject to certain conditions. (2) If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to: (a) Affirm its order of summary suspension; (b) Rescind the order for summary suspension; (c) Enter into an order agreed upon by the parties; or (d) Enter into any interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (3) An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings are final orders of the Board and public records pursuant to State Government Article, §10-611, Annotated Code of Maryland. G. Post-Deprivation Opportunity for an Evidentiary Hearing. (1) If the Board orders the summary suspension of a license pursuant to §C or D of this regulation, the respondent shall be provided with the opportunity for an evidentiary hearing before the Board or before an administrative law judge, if the Board delegates the matter to the Office of Administrative Hearings. (2) The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension. (3) Unless otherwise agreed by the parties, a hearing shall be provided within 45 days after the respondent's request. (4) An evidentiary hearing may be consolidated with a hearing on charges issued by the Board which include the facts which form the basis for the summary suspension. (5) An evidentiary hearing shall be conducted pursuant to the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (6) If the Board has delegated the matter to the Office of Administrative Hearings, the administrative law judge shall issue to the Board a recommended decision with: (a) Proposed or final findings of fact; (b) Proposed or final conclusions of law; (c) A proposed disposition; or (d) Any combination of §G(6)(a) — (c) of this regulation pursuant to the Board's delegation of the matter to the Office of Administrative Hearings. (7) If the hearing is one combined with charges, the administrative law judge's determination as to the merits of the summary suspension shall be based only on those parts of the record that were available to the Board at the time it voted for the summary suspension. (8) The parties may file exceptions to the recommended decision as provided in State Government Article, §10-216, Annotated Code of Maryland. (9) An order issued by the Board after a post-deprivation evidentiary hearing is a final order of the Board and is a public record pursuant to State Government Article, §10-611, Annotated Code of Maryland. #### Regulation .08 Probation and Violation of Probation Proceedings. *COMAR 10.28.04.08* A. If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation which the Board deems appropriate, including: (1) Re-education or completion of approved courses; (2) Payment of a fine; (3) Providing free optometric services in a Board-approved program; (4) Practicing under supervision; (5) Monitoring by the Board or by an individual or entity approved by the Board with periodic reporting to the Board; (6) Periodic review of a licensee's clinical practices or billing; (7) Periodic audits of a licensee's billing practices; (8) An examination by a physician or other appropriate health care provider; (9) Limitation of the licensee's practice; (10) Obtaining a passing score on an appropriate examination; or (11) Any other condition the Board deems appropriate for the rehabilitation or retraining of a licensee. B. A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the licensee. C. A licensee seeking termination of probation shall do so only by petitioning the Board to lift the probation when the: (1) Specific period of time has passed; or (2) Licensee has successfully completed the conditions or acts required for termination. D. If, at any time, the Board determines that the licensee is not in compliance with the conditions of probation, the Board shall: (1) Charge the licensee with a violation of probation; (2) Take any action provided for in the final order or consent order in the event of a violation of probation, including suspension of the license; (3) Consider a summary suspension of the license; or (4) Take any other action the Board deems appropriate and which the Board is authorized to take by law. E. Charges for Violation of Probation. (1) If the Board issues charges for a violation of probation, the service shall be as provided for in Regulation .05C(1) and (3) of this chapter. (2) The charging document for a violation of probation shall: (a) Inform the respondent of the statutory provision, condition of probation, or provision of the Board's order which the Board believes has been violated; (b) Allege facts that constitute a basis for a violation of probation; and (c) Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing. (3) If the respondent requests a hearing on the charge of a violation of probation, the Board shall, before the hearing, provide the respondent with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter. F. Violation of Probation Hearing. A hearing for a violation of probation shall be held as set out in Regulation .06B of this chapter. G. If the Board determines that the respondent has violated probation, the Board shall: (1) Take any action provided for in the consent order or final order in the event of a violation of probation; (2) Impose additional conditions of probation; or (3) Impose any sanction or take any other action that the Board deems appropriate and is authorized to take by law. #### Regulation .09 Restoration of a License. *COMAR 10.28.04.09* A. Reinstatement. (1) A licensee shall petition the Board for a lifting of a suspension of a license or a reinstatement following revocation or surrender of a license. (2) A licensee who petitions the Board for reinstatement pursuant to terms and conditions for reinstatement set out in a final order, letter of surrender, or other order of the Board shall apply for reinstatement only pursuant to those terms and conditions. (3) A licensee whose license has been revoked or surrendered for 3 years or more before filing a petition for reinstatement is not eligible for reinstatement but instead shall apply for initial licensure. (4) In addition to complying with any conditions for reinstatement ordered by the Board, an applicant for reinstatement shall: (a) File an application for reinstatement with the Board; (b) Meet the requirements for reinstatement set out in COMAR 10.28.05; and (c) Achieve a passing score on the Board's law examination. B. Notice of Intent to Deny Reinstatement and Opportunity for a Hearing. (1) If the Board issues a notice of intent to deny reinstatement, that notice shall be served as provided for in Regulations .05C(1) and (3) of this chapter. (2) A notice of intent to deny reinstatement shall: (a) Inform the applicant of the legal basis for the Board's belief that the applicant is not qualified for reinstatement, including any applicable statutory provision; (b) Allege any facts which the Board believes support the Board's reasons for denying reinstatement; and (c) Notify the respondent of any proceedings scheduled before the Board or of an opportunity to request a hearing within a certain period of time and the consequences of failing to appear for those proceedings or to request a hearing. (3) If the applicant requests a hearing on the notice of intent to deny reinstatement, the Board shall, before the hearing, provide the applicant with a case resolution conference as provided in Regulation .05E of this chapter, to discuss settlement of the matter. (4) A hearing on the notice of denial of reinstatement shall be held before the Board or be delegated to an administrative law judge and conducted pursuant to the contested case provisions of the Administrative Procedure Act. C. If the Board grants reinstatement of a license, it may impose any restrictions or conditions on the license or the licensee's practice that it deems appropriate. #### Regulation .10 Judicial Review. *COMAR 10.28.04.10* A final order of the Board is subject to judicial review as provided in Health Occupations Article, §11-318, and State Government Article, §10-222, Annotated Code of Maryland. #### Regulation .11 Imposition of Penalties. *COMAR 10.28.04.11* The Board may impose a civil monetary penalty in lieu of or in addition to a disciplinary sanction authorized by Health Occupations Article, §11-313, Annotated Code of Maryland as provided in COMAR 10.28.13. #### Regulation .12 Consideration and Notice of Board Files. *COMAR 10.28.04.12* In any matter governed by this chapter, the Board may take official notice of any information contained in the Board's files. ### Chapter 05 — Inactive Status and Reinstatement of Expired Licenses **Authority:** Health Occupations Article, §11-310, Annotated Code of Maryland **Administrative History:** Effective date: April 11, 1983 (10:7 Md. R. 634) **Administrative History:** Regulation .03A amended effective July 7, 2025 (52:13 Md. R. 656) **Administrative History:** Regulation .03B amended effective March 4, 2002 (29:4 Md. R. 417) #### Regulation .01 Inactive Status. *COMAR 10.28.05.01* The Board shall place a license on inactive status, if the licensee submits to the Board: A. An application for inactive status on the form required by the Board; and B. The inactive status fee required by COMAR 10.28.07. #### Regulation .02 Application for Active Licensure by Optometrist on Inactive Status. *COMAR 10.28.05.02* An optometrist who is on inactive status may apply for reinstatement of active licensure. The Board shall issue an active license if the optometrist: A. Submits to the Board satisfactory proof of completion of continuing education hours required of a practitioner on active status during the period of inactivity, not to exceed 125 hours; and B. Pays to the Board the reinstatement fee required by COMAR 10.28.07. #### Regulation .03 Reinstatement of Expired License. *COMAR 10.28.05.03* A. Any optometrist whose license has been expired for less than 5 years and who has not been put on inactive status may apply for reinstatement of their license. The Board may reinstate the license if the optometrist: (1) Submits to the Board satisfactory proof of having subsequently met the continuing education requirements required of a practitioner on active status during the period the license was expired, not to exceed 125 hours; (2) Otherwise meets the renewal requirements set forth in Health Occupations Article, §11-308, Annotated Code of Maryland; and (3) Pays to the Board the fee for the same number of renewal cycles lapsed plus $50. B. The Board may reinstate the license of any optometrist whose license has been expired for 5 years or more and who has not been put on inactive status, or practiced optometry, only if the optometrist passes an examination recognized by the Board. ### Chapter 06 — Examination of Patients by Optometrists, Maintenance of Records, and Keeping of Certain Instrumentation and Equipment **Authority:** Health Occupations Article, §§11-205 and 11-208, Annotated Code of Maryland **Administrative History:** Effective date: June 4, 1984 (11:11 Md. R. 962) **Administrative History:** Regulation .02 amended effective July 31, 2017 (44:15 Md. R. 760) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective November 7, 1994 (21:22 Md. R. 1876) **Administrative History:** Regulation .04 amended effective November 7, 1994 (21:22 Md. R. 1876) **Administrative History:** Regulation .05 repealed and new Regulation .05 adopted effective November 7, 1994 (21:22 Md. R. 1876) #### Regulation .01 Scope. *COMAR 10.28.06.01* These regulations establish criteria the Board considers necessary to perform a minimum optometric examination, maintain certain records, and have on hand certain instrumentation and equipment required to carry out procedures for the minimum examination. #### Regulation .02 Patient History. *COMAR 10.28.06.02* An optometrist shall review the patient's history and shall create a written, oral, or electronic record of the following: A. Previous vision examinations, prescriptions, treatment programs; B. Patient's general health history including ocular health, familial involvements, current medications, and allergy history; C. Patient's primary complaint, symptoms, or other reason for consulting the practitioner; D. Other information bearing on visual tasks to be performed. #### Regulation .03 Examination. *COMAR 10.28.06.03* A licensee shall perform all necessary tests, evaluations, and observations in accordance with Health Occupations Article, §11-208(a), Annotated Code of Maryland, to ensure appropriate optometric management of the patient's ocular, systemic, visual, and psychosocial conditions. #### Regulation .04 Records. *COMAR 10.28.06.04* A licensed optometrist shall maintain thorough records of all testing procedures, results, and case dispositions in accordance with Health-General Article, §4-403, Annotated Code of Maryland. The optometrist shall record all tests, evaluations, and observations performed, along with assessment and plan. #### Regulation .05 Equipment. *COMAR 10.28.06.05* A licensed optometrist shall have on hand all necessary equipment in good working condition to perform the procedures as required in Regulations .03 and .04 of this chapter. ### Chapter 07 — Fee Schedule **Authority:** Health Occupations Article, §§11-205, 11-207, and 11-302—11-308, Annotated Code of Maryland **Administrative History:** Effective date: October 22, 1984 (11:21 Md. R. 1814) **Administrative History:** Regulation .02 amended as an emergency provision effective August 18, 1992 (19:18 Md. R. 1653); amended permanently effective January 2, 1993 (19:25 Md. R. 2206) **Administrative History:** Regulation .02 amended effective March 4, 2002 (29:4 Md. R. 417) **Administrative History:** Regulation .02 amended as an emergency provision effective January 30, 2003 (30:4 Md. R. 314); amended permanently effective March 31, 2003 (30:6 Md. R. 420) **Administrative History:** Regulation .02 amended effective December 11, 2003 (30:24 Md. R. 1741); July 7, 2025 (52:13 Md. R. 656) **Administrative History:** Regulation .02H repealed effective July 31, 2017 (44:15 Md. R. 760) **Administrative History:** Regulation .02I, J repealed effective October 19, 2009 (36:21 Md. R. 1591) #### Regulation .01 Scope. *COMAR 10.28.07.01* These regulations govern all persons licensed as optometrists by the State. #### Regulation .02 Fees. *COMAR 10.28.07.02* The following fees are established by the Board: A. Application fee—$300; B. Biennial renewal license fee— $600; C. Inactive license fee—$250; D. Late fee (payable if renewal fee is received within the 30-day grace period)—$100; E. Reinstatement fee (payable after failure to renew license for less than 5 years). Licensee shall also pay renewal fees for number of renewal cycles lapsed—$50; F. Reinstatement fee to active licensure (payable to change from inactive status to active status licensure)—$100; G. Fee for failure to maintain correct mailing address, name, or email address with the Board—$50; and H. License verification fee (per state or entity)—$25. #### Regulation .03 Change of Fees. *COMAR 10.28.07.03* Fees are subject to change by action of the Board of Examiners in Optometry. All licensees and applicants will be notified of the change. ### Chapter 08 — Licensure Eligibility: Out-of-State Applicants **Authority:** Health Occupations Article, §§11-205 and 11-302—11-308, Annotated Code of Maryland **Administrative History:** Effective date: March 11, 1985 (12:5 Md. R. 483) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective August 28, 1995 (22:17 Md. R. 1318) **Administrative History:** Regulation .01A amended effective March 4, 2002 (29:4 Md. R. 417) **Administrative History:** Regulation .02 amended effective August 28, 1995 (22:17 Md. R. 1318) **Administrative History:** Chapter revised effective March 26, 2007 (34:6 Md. R. 627) **Administrative History:** Chapter revised effective July 7, 2025 (52:13 Md. R. 656) #### Regulation .01 Definition. *COMAR 10.28.08.01* A. In this chapter, the following term has the meaning indicated. B. Term Defined. “Active practice” means practices optometry for at least a total of 500 hours within 3 consecutive years, immediately before applying for licensure. #### Regulation .02 Application. *COMAR 10.28.08.02* A. An applicant for licensure under this chapter shall: (1) Complete and submit to the Board an application; (2) Pay the application fee required by COMAR 10.28.07.02; and (3) Submit proof that the applicant meets the requirements of Health Occupations Article, §11-305, Annotated Code of Maryland. B. An applicant shall submit the following documentation with the application: (1) A copy of a current license from another state; (2) An affidavit from the other state licensing board attesting that the applicant became licensed in the other state by passing an examination approved by the board of optometry in that state; (3) An affidavit from a colleague, employer, or other source approved by the Board attesting that the applicant has: (a) Engaged in active practice immediately before applying for licensure under this chapter; or (b) Was a teaching optometrist, a military optometrist, a supervisor or administrative optometrist, or a researcher in optometry for 3 years immediately before applying for licensure under this chapter; (4) An affidavit from the other state licensing board attesting that the applicant has met the continuing education requirements for the state in which the applicant has been practicing; and (5) Proof of the equivalent of 3 years of continuing education hours as required of optometrists in Maryland in courses approved by the Board if the other state does not require continuing education hours. #### Regulation .03 Examination. *COMAR 10.28.08.03* An approved applicant for licensure under this chapter shall: A. Be given a Maryland Board of Examiners in Optometry jurisprudence examination; and B. Obtain a minimum score of 75 percent. ### Chapter 09 — Advertising **Authority:** Health Occupations Article, §§11-205 and 11-313, Annotated Code of Maryland **Administrative History:** Effective date: September 7, 1987 (14:18 Md. R. 1966) **Administrative History:** Regulation .02B amended effective July 31, 2017 (44:15 Md. R. 760) **Administrative History:** Regulation .04A amended effective March 4, 2002 (29:4 Md. R. 417) #### Regulation .01 Scope. *COMAR 10.28.09.01* These regulations govern advertising by optometrists in Maryland. #### Regulation .02 Definitions. *COMAR 10.28.09.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Advertising” means calling to the attention of the public the services one has to offer, including, but not limited to, by written, oral, or electronic methods. (2) “Board” means the State Board of Examiners in Optometry. (3) “Optometrist” means an individual who holds a current license to practice optometry in Maryland. #### Regulation .03 Advertising. *COMAR 10.28.09.03* A. An optometrist may advertise the optometrist's services subject to the provisions of this regulation. B. An advertisement may not contain statements: (1) Containing misrepresentation of facts; (2) Likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts; (3) Intended to or likely to create false or unjustified expectations of favorable results; (4) Relating to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to a layman; (5) Conveying the impression that the optometrist could influence improperly any public body, official, corporation, or any person on behalf of a patient; (6) Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent person to misunderstand or be deceived; (7) Containing representations that the optometrist is willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States; (8) That fail to state that the practitioner is an optometrist. C. An optometrist shall also be accountable under this regulation if the optometrist uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation. #### Regulation .04 Solicitation. *COMAR 10.28.09.04* A. An optometrist may not engage in solicitation, including but not limited to in-person, telephone, facsimile, internet, or direct mail solicitation which: (1) Amounts to fraud, undue influence, intimidation, or overreaching; (2) Contains statements which would be improper under Regulation .03B. B. An optometrist shall also be accountable under this regulation if the optometrist uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation. #### Regulation .05 Penalties for Violation. *COMAR 10.28.09.05* A violation of these regulations pertaining to the use of advertising shall constitute unprofessional conduct and may result in disciplinary action against the optometrist under Health Occupations Article, §§11-205 and 11-313, Annotated Code of Maryland. ### Chapter 10 — Optometrist Accountability **Authority:** Health Occupations Article, §§11-205(a) and 11-311, Annotated Code of Maryland **Administrative History:** Effective date: September 7, 1987 (14:18 Md. R. 1967) **Administrative History:** Regulation .02B amended effective July 31, 2017 (44:15 Md. R. 760) #### Regulation .01 Scope. *COMAR 10.28.10.01* These regulations govern all optometrists licensed to practice in Maryland. #### Regulation .02 Practitioner Identification. *COMAR 10.28.10.02* Licensed practicing optometrists shall, in an appropriate manner, ensure that the patient knows the identity of the provider of optometric care by providing that: A. The names of the optometrists providing services are conspicuously posted in the office; B. The name of the licensed optometrist, or some other method of identifying the optometrist providing the optometric services, appears on any record required by law or regulation; and C. Treatment records are maintained and clearly identify the licensed optometrist who recommends, instructs, or prescribes vision care for the patient. ### Chapter 11 — Use of Diagnostic Pharmaceutical Agents **Authority:** Health Occupations Article, §§11-101, 11-205, and 11-404, Annotated Code of Maryland **Administrative History:** Effective date: May 14, 1990 (17:9 Md. R. 1090) **Administrative History:** Regulation .01 amended effective July 31, 2017 (44:15 Md. R. 760) **Administrative History:** Regulation .02A, B amended effective November 20, 1994 (21:33 Md. R. 1933); July 31, 2017 (44:15 Md. R. 760) **Administrative History:** Regulation .03 amended effective March 4, 2002 (29:4 Md. R. 417) **Administrative History:** Regulation .04 amended effective November 20, 1994 (21:33 Md. R. 1933) **Administrative History:** Regulation .04D amended effective July 7, 2025 (52:13 Md. R. 656) #### Regulation .01 Definitions. *COMAR 10.28.11.01* A. In this chapter, the following term has the meaning indicated. B. Term Defined. “Optometric management of ocular disease” means the use of optometric services and techniques to determine the most appropriate and timely referral for ocular disease. #### Regulation .02 Diagnostic Pharmaceutical Agents. *COMAR 10.28.11.02* A. An optometrist certified by the Board as qualified to administer diagnostic pharmaceutical agents may use the following agents: (1) Agents directly or indirectly affecting the pupil of the eye, including, but not limited to, the mydriatics and cycloplegics listed below: (a) Phenylephrine hydrochloride (2.5 percent); (b) Hydroxyamphetamine hydrobromide (1.0 percent); (c) Cyclopentolate hydrochloride (0.5—2.0 percent); (d) Tropicamide (0.5 and 1.0 percent); (e) Cyclopentolate hydrochloride (0.2 percent) with phenylephrine hydrochloride (1.0 percent); (f) Dapiprazole hydrochloride (0.5 percent); (g) Hydroxyamphetamine hydrobromide (1.0 percent) and tropicamide (0.25 percent); and (2) Agents directly or indirectly affecting the sensitivity of the cornea, including, but not limited to, the: (a) Topical anesthetics listed below: (i) Proparacaine hydrochloride (0.5 percent); and (ii) Tetracaine hydrochloride (0.5 percent); (b) Diagnostic topical anesthetic and dye combinations listed below: (i) Benoxinate hydrochloride (0.4 percent)—fluorescein sodium (0.25 percent); and (ii) Proparacaine hydrochloride (0.5 percent)—fluorescein sodium (0.25 percent). B. The optometrist may use the diagnostic pharmaceutical agents listed in §A of this regulation in strengths not greater than the strengths indicated unless clinically indicated. C. The optometrist may not dispense diagnostic pharmaceutical agents to patients for self-administration. #### Regulation .03 Certification. *COMAR 10.28.11.03* A. The Board will certify an optometrist licensed to practice in Maryland as qualified to administer diagnostic pharmaceutical agents if the licensed optometrist meets one of the following criteria: (1) Graduation from an accredited school of optometry within 7 years before applying for certification in Maryland. (2) Certification to use diagnostic pharmaceutical agents in another state which included completion of not less than 70 credit hours in diagnostic pharmaceutical agents if the optometrist: (a) Submits to the Board proof of certification to use diagnostic pharmaceutical agents in the other state. (b) Submits to the Board documentation that the original certification included at least 70 credit hours in diagnostic pharmaceutical agents. This documentation may be from either: (i) The state board that granted the original certification; (ii) The college, university, association, or other sponsors of the 70 credit hours in diagnostic pharmaceutical agents; or (iii) Any other organization approved by the Board. (3) Successful completion of a course in diagnostic pharmaceutical agents of at least 70 credit hours given by an accredited college or faculty approved by the Board within 7 years before applying for certification in Maryland. B. The credit hours taken for initial certification in diagnostic pharmaceutical agents may be included as part of the hours of continuing education required for biennial license renewal. C. To complete the certification process, the optometrist shall submit proof of current certification in cardiopulmonary resuscitation to the Board. #### Regulation .04 Renewal of Certification. *COMAR 10.28.11.04* A. An optometrist certified under this chapter shall complete 6 credit hours of continuing education every 2 years in the use of diagnostic pharmaceutical agents in the diagnosis and optometric management of ocular disease. B. The 6 credit hours of continuing education relating to the use of diagnostic pharmaceutical agents required every 2 years to maintain certification may be included as part of the hours of continuing education required for biennial license renewal. C. An optometrist is responsible for maintaining proficiency with the current CPR procedures as recommended by the American Heart Association. D. The Board shall grant 3 continuing education hours for CPR recertification courses per biennial license renewal. #### Regulation .05 Reporting. *COMAR 10.28.11.05* An optometrist certified to use diagnostic pharmaceutical agents shall report to the Board, on the form provided by the Board, any incident of adverse reaction to the administration of diagnostic pharmaceutical agents. ### Chapter 12 — Therapeutic Pharmaceutical Agents **Authority:** Health Occupations Article, §§11-101, 11-205, 11-302—11-309, 11-401.1, 11-404, and 11-404.1, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.08 adopted as an emergency provision effective May 17, 1996 (23:12 Md. R. 867); adopted permanently effective October 21, 1996 (23:21 Md. R. 1467) **Administrative History:** Regulation .01B amended effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulations .02 amended as an emergency provision effective December 7, 2001 (28:26 Md. R. 2270); amended permanently effective March 4, 2002 (29:4 Md. R. 417) **Administrative History:** Regulation .02 amended effective October 19, 2009 (36:21 Md. R. 1591); May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulations .06 amended effective October 15, 2001 (28:20 Md. R. 1783) **Administrative History:** Regulation .06A, C amended effective October 19, 2009 (36:21 Md. R. 1591) **Administrative History:** Regulations .08 repealed effective October 15, 2001 (28:20 Md. R. 1783) **Administrative History:** Chapter revised effective November 15, 2021 (48:23 Md. R. 980) **Administrative History:** Regulation .02 amended effective July 7, 2025 (52:13 Md. R. 656) #### Regulation .01 Definitions. *COMAR 10.28.12.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adverse drug reaction” means a physical or psychological reaction experienced by a patient which: (a) Results from the administration of diagnostic or therapeutic pharmaceutical agents; (b) Poses a threat to the health of the patient; and (c) Requires treatment or medical intervention. (2) “Adverse reaction” means the unintended or unexpected effect of treatment on a patient caused by or resulting from: (a) An adverse drug reaction; (b) The removal of a superficial foreign body from the eye; or (c) The ordering of a laboratory test. (3) “Board” means the Board of Examiners in Optometry. (4) “Diagnostic pharmaceutical agent (DPA)” means a medication that: (a) Directly or indirectly affects the pupil of the eye as defined in COMAR 10.28.11; (b) Directly or indirectly affects the sensitivity of the cornea as defined in COMAR 10.28.11; or (c) Stains the ocular surface. (5) “Ophthalmologist” means a physician who practices in the specialty of ophthalmology and who is licensed by the Maryland Board of Physicians. (6) “Primary open angle glaucoma” means glaucomatous changes characterized by: (a) Adult onset; (b) The presence of open, normal appearing angles as demonstrated by gonioscopy, and not otherwise explained; and (c) One or more of the following: (i) The appearance of optic disc damage or optic nerve fiber layer damage as evidenced by the size or shape of the optic disc cup, thinning or notching of the optic disc rim, progressive changes in the appearance of the optic disc cup, optic disc hemorrhage, or nerve fiber layer defects, seen clinically or via imaging; (ii) The presence of abnormalities in the visual field including arcuate defect, nasal step, paracentral scotoma, or general depression, in the absence of other causes or explanations for a visual field defect; or (iii) Intraocular pressure that is thought to pose a threat to the health of the optic nerve. (7) “Secretary” means the Secretary of Health. (8) “Therapeutic pharmaceutical agent (TPA)” means a medication used for the treatment of a disease or condition of the eye as specified in Health Occupations Article, §11-404.2, Annotated Code of Maryland. (9) “Therapeutically certified optometrist” means a licensed optometrist who has fulfilled the requirements of the Board and is certified by the Board to use therapeutic pharmaceutical agents in the practice of optometry and provides therapeutic services to patients in Maryland. (10) “TPA record” means the optometrist's documentation of a patient's visit, the result of which involved the prescribing of medication or the performance of a procedure for treatment of a medical eye condition by a therapeutically certified optometrist. (11) “Universal precautions” has the meaning stated in COMAR 10.06.01.02B(10). #### Regulation .02 Requirements for Certification. *COMAR 10.28.12.02* A. Except for an optometrist who qualifies under §C or D of this regulation, the Board shall certify an optometrist licensed to practice in Maryland as qualified to use TPAs if the licensed optometrist submits to the Board evidence satisfactory to the Board that the optometrist: (1) Has successfully completed at least 110 hours of Board-approved TPA education before applying for certification to use TPAs; (2) Has successfully passed the National Board of Examiners in Optometry's (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections; and (3) Is currently certified by the Board to administer topical ocular DPAs. B. The Board may consider pharmacology courses that an optometrist successfully completed during a course of study at an accredited school of optometry recognized by the Board when calculating the 110 hours of Board-approved TPA education required under §§A(1) and D(1) of this regulation. If accepted by the Board, then each: (1) Semester credit hour will equal 15 hours of TPA education; and (2) Quarter credit hour will equal 10 hours of TPA education. C. The Board shall certify an optometrist who has graduated from an accredited school of optometry within 3 years before applying for certification to use TPAs if the optometrist: (1) Submits proof of current certification in cardiopulmonary resuscitation (CPR) to the Board; and (2) Completes the process to become certified to use TPAs within 3 years of the date of graduation from an accredited school of optometry. D. If an optometrist who has graduated on or after July 1, 2005, from an accredited school of optometry recognized by the Board, is not certified within 3 years of graduation, the Board shall certify the optometrist to use TPAs if the optometrist: (1) Has successfully completed at least 110 hours of Board-approved TPA education before applying for certification to use TPAs; (2) Has successfully passed the National Board of Examiners in Optometry's (NBEO) exam, including the Treatment and Management of Ocular Disease (TMOD) Examination and clinical exam sections; and (3) Submits proof of current certification in cardiopulmonary resuscitation (CPR) to the Board. E. The credit hours taken for initial certification in TPAs may be included as part of the hours of continuing education required for biennial license renewal. #### Regulation .03 Requirements for Renewal of Certification. *COMAR 10.28.12.03* A. An optometrist certified by the Board under this chapter shall complete 50 hours of continuing education during the 2 year licensure period in order to renew the optometrist's license. B. An optometrist certified by the Board under this chapter shall complete 30 hours of continuing education in the use and management of TPAs, during the 2-year licensure period. C. The Board shall count the 30 hours of continuing education in TPAs toward the 50 hours of continuing education required for biennial renewal. D. A therapeutically certified optometrist shall be certified in CPR and shall verify this certification on request by the Board. E. Unless there are extenuating circumstances acceptable to the Board, the Board shall revoke the TPA certification of an optometrist who does not fulfill the requirements for renewal of the TPA certification. F. TPA Self-Assessment. At the time of license renewal, the therapeutically certified optometrist shall complete a self-assessment checklist provided by the Board to evaluate the following aspects of the optometrist’s practice utilizing TPAs, including but not limited to: (1) Legibility and completeness of TPA records; (2) Documentation of patient visits, services rendered, and communications; (3) Documentation of subjective complaints, objective findings, clinical assessments relating to the findings of the diagnosis, and the plan; (4) A written office plan for handling emergencies; (5) A system for patients to reach the optometrist, or to access care, in the event of an ocular emergency; (6) A systematic discarding of expired medications; (7) Documentation of current CPR certification; (8) An infection control policy; (9) Patient confidentiality; (10) A patient tracking system that enables identification and follow-up to ensure treatment of patients who: (a) Are being followed or referred out for emergency sight or life-threatening conditions; or (b) Fail to keep appointments; (11) Procedures for appropriate termination of the doctor-patient relationship when necessary; (12) Satisfactory explanation of the treatment plan so that the patient knows and understands the nature of the patient’s problem or problems and the goals of the treatment regimen; and (13) Advice to patients regarding the importance of progress examinations and follow-up care. #### Regulation .04 Standards of Quality for Therapeutically Certified Optometrists and Optometric Care. *COMAR 10.28.12.04* A. The therapeutically certified optometrist shall provide clinical therapeutic eye care consistent with published, universally accepted practice or clinical guidelines and standards of care. B. The therapeutically certified optometrist shall adhere to the additional guidelines and standards of care given in §§C—T of this regulation. C. The therapeutically certified optometrist shall ensure that: (1) TPA records are consistent with the Subjective, Objective, Assessment, and Plan (SOAP) format; (2) Assessment and plans are consistent with the patient's subjective and clinical findings; and (3) TPA records are complete and legible. D. The therapeutically certified optometrist shall document the following data, if applicable, for each TPA patient visit or communication: (1) Date of service; (2) Current Procedural Terminology (CPT) Code, most recent edition; (3) International Classification of Diseases (ICD) Code, most recent edition; (4) Medication/treatment provided; and (5) Follow-up recommendation. E. The therapeutically certified optometrist shall document the following data as part of the patient's permanent file: (1) Name; (2) Date of birth; (3) Name of the doctor to whom the patient is referred, appointment date, and documentation that the patient or guardian preferred to schedule the referral appointment on their own; (4) Record of tests administered and the results of the tests; (5) Written reports of other consultations, referrals received, or both; and (6) Documentation of the occurrence of any adverse reaction. F. The therapeutically certified optometrist shall provide for 24-hour emergency coverage. G. The therapeutically certified optometrist shall have a medical kit for treating anaphylactic emergencies available at each location where patients are seen. H. The therapeutically certified optometrist shall be certified in CPR. I. The therapeutically certified optometrist shall have a written plan for responding to emergencies, including specific plans for referral to hospital emergency rooms, emergency ambulatory centers, ophthalmologists, or other appropriate medical doctors when necessary at each location where patients are seen. J. The therapeutically certified optometrist shall comply with: (1) Applicable national and State standards of infection control at each office; and (2) Principles of universal precautions as defined in COMAR 10.06.01.02B(10). K. The therapeutically certified optometrist shall maintain a written tracking system to identify patients who are being followed or referred for emergency sight or life-threatening conditions and who fail to keep appointments. L. The therapeutically certified optometrist shall document that a patient who fails to keep an appointment for an emergency sight or life-threatening condition was contacted by: (1) Telephone; (2) Electronic mail or other electronic means; (3) Text message; or (4) Mail. M. The therapeutically certified optometrist shall report all adverse reactions to the Board. An adverse drug reaction may be indicated by symptoms which include, but are not limited to, painful eye, pruritus, urticarial lesions, wheals, skin rash of periorbital tissues, nausea, vomiting, fainting, confusion, cessation of respiration, wheezing, clinically significant change in heart rate, or chest pain. N. The therapeutically certified optometrist shall prescribe and administer all therapeutic pharmaceutical agents in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland. O. The therapeutically certified optometrist shall remove superficial foreign bodies from the eye in accordance with the applicable standards of care established under Health Occupations Article, Title 11, Annotated Code of Maryland. P. A therapeutically certified optometrist may not prescribe or administer a therapeutic pharmaceutical agent unless specifically authorized by law or these regulations. Q. The therapeutically certified optometrist shall report to the Board, on the form provided by the Board, within 10 working days of the occurrence, an adverse reaction. The therapeutically certified optometrist shall include in the report, at a minimum, the following: (1) The optometrist's name, address, and license number; (2) Patient information including: (a) Presenting problem; (b) Diagnosis; (c) Agent administered; and (d) Method of administration; (3) The adverse reaction; and (4) Subsequent action taken. R. Glaucoma Management. (1) In accordance with Health Occupations Article, §11-404.2, Annotated Code of Maryland, a therapeutically certified optometrist shall perform the procedures and tests necessary to diagnose primary open angle glaucoma appropriately. (2) A therapeutically certified optometrist may administer and prescribe topical pharmaceutical agents for glaucoma only as authorized by law. S. In developing a glaucoma treatment plan that ensures the maximum effectiveness for the patient, the therapeutically certified optometrist shall consider the following: (1) Types of agents to be administered and potential side effects; (2) Status of the optic nerve structure, function, and its relationship to intraocular pressure; (3) Identification of a target intraocular pressure at or below the target level in which further optic nerve damage is unlikely to occur; (4) Maintenance of intraocular pressure at or below the target level by initiating appropriate therapeutic intervention; (5) Monitoring of the optic nerve and resetting the target intraocular pressure if deterioration occurs; (6) Minimization of the side effects of treatment and their impact on the patient's vision, general health, and quality of life; (7) Education of the patient in the management of primary open angle glaucoma disease; (8) Reference to accepted clinical guidelines for glaucoma follow-up management; and (9) Criteria for surgical intervention. T. Laboratory Tests. Laboratory tests shall be ordered by a therapeutically certified optometrist only as provided by law. #### Regulation .05 Monitoring of Complaint Investigation. *COMAR 10.28.12.05* A. The Board shall review complaints against optometrists relating to ocular therapeutics, management of primary open angle glaucoma, removal of superficial foreign bodies, and other aspects of practice by a therapeutically certified optometrist. B. The Board's procedures for handling complaints are governed by Health Occupations Article, Title 11, Annotated Code of Maryland, COMAR 10.28.04, and State Government Article, §§10-201—10-227, Annotated Code of Maryland. ### Chapter 13 — Civil Penalties **Authority:** Health Occupations Article, §§11-205, 11-313 — 11-315, and 11-505, Annotated Code of Maryland **Administrative History:** Effective date: April 20, 1998 (25:8 Md. R. 597) **Administrative History:** Regulation .01 amended effective August 17, 2015 (42:16 Md. R. 1055) **Administrative History:** Regulation .02B amended effective August 17, 2015 (42:16 Md. R. 1055) **Administrative History:** Regulation .05A, C amended effective August 17, 2015 (42:16 Md. R. 1055) **Administrative History:** Regulation .06 adopted effective August 17, 2015 (42:16 Md. R. 1055) #### Regulation .01 Scope. *COMAR 10.28.13.01* This chapter establishes the standards by which the Board may: A. Impose an administrative monetary penalty not exceeding $5,000 on an individual licensed under Health Occupations Article, Title 11, Annotated Code of Maryland, for an act or omission prohibited under Health Occupations Article, §11-313, Annotated Code of Maryland; or B. Assess a civil fine not exceeding $50,000 on a person who violates Health Occupations Article, §11–501, 11–502, or 11–504, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.28.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Examiners in Optometry. (2) “Licensee” means an individual licensed by the Board to practice optometry. (3) “Violation” means: (a) An act or omission prohibited under Health Occupations Article, §11-313, Annotated Code of Maryland; or (b) An act prohibited under Heath Occupations Article, §11-501, 11-502, or 11-504, Annotated Code of Maryland. #### Regulation .03 Authority to Impose an Administrative Monetary Penalty. *COMAR 10.28.13.03* A. After a hearing under Health Occupations Article, §11-315, Annotated Code of Maryland, and COMAR 10.28.04, the Board may impose an administrative monetary penalty of $5,000 or less on a licensee who is found to have committed a violation. B. The Board may impose a penalty under §A of this regulation: (1) For each occasion the licensee commits a violation, not to exceed a maximum of $5,000; (2) In addition to suspension or revocation of a license; or (3) Instead of suspension of a license. #### Regulation .04 Factors to be Considered in the Assessment of Penalties. *COMAR 10.28.13.04* In determining whether to impose a penalty and the amount of the penalty, the Board shall consider the following factors: A. The cost of investigating and prosecuting the case against the individual; B. The extent of actual or potential public harm caused by the violation; C. The extent to which the individual derived a financial benefit from the violation; D. The history of a previous violation or violations; E. The willfulness of the improper conduct; and F. Mitigating factors as presented by the licensee. #### Regulation .05 Payment of Penalties. *COMAR 10.28.13.05* A. Within 30 days of the date of the Board’s order: (1) A licensee shall pay to the Board the administrative monetary penalty imposed; or (2) A person shall pay the civil fine assessed by the Board. B. The Board shall pay into the General Fund of the State all monies collected under this chapter. C. If a licensee fails to pay, in whole or in part, a penalty imposed by the Board, the Board may not restore, reinstate, or renew the license of the licensee until the licensee pays the penalty in full. D. The Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings and ensure prompt payment. #### Regulation .06 Civil Fines. *COMAR 10.28.13.06* A. After a hearing under Health Occupations Article, §11–315, Annotated Code of Maryland, and COMAR 10.28.04, the Board may assess a civil fine not to exceed $50,000 against a person who: (1) Practices optometry without a license in violation of Health Occupations Article, §11–501, Annotated Code of Maryland; (2) Misrepresents to the public by title, by description of services, methods, or procedures, or otherwise that the person practices optometry in violation of Health Occupations Article, §11–502, Annotated Code of Maryland; or (3) Knowingly sells or dispenses contact lenses or replacement contact lenses without a valid and unexpired prescription or replacement contact lens prescription in violation of Health Occupations Article, §11–504, Annotated Code of Maryland. B. In determining whether to assess a fine and the amount of the fine, the Board shall consider the following factors: (1) The cost of investigating and prosecuting the case against the person; (2) The extent of actual or potential public harm caused by the violation; (3) The extent to which the person derived a financial benefit from the violation; (4) The history of a previous violation or violations; (5) The willfulness of the improper conduct; and (6) Mitigating factors as presented by the person. ### Chapter 14 — Code of Conduct **Authority:** Health Occupations Article, §§1-212 and 11-205, Annotated Code of Maryland **Administrative History:** Effective date: June 26, 2000 (27:12 Md. R. 1140) **Administrative History:** Chapter revised effective July 31, 2006 (33:15 Md. R. 1281) #### Regulation .01 Scope. *COMAR 10.28.14.01* This chapter governs all optometrists licensed by the State Board of Examiners in Optometry to practice in the State. #### Regulation .02 Definitions. *COMAR 10.28.14.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Examiners in Optometry. (2) “Inappropriate sexual language” means: (a) A sexualized harassing comment; (b) An eroticized or sexually provocative comment not reasonably associated with a health care matter; or (c) An inappropriate discussion of a sexually related matter. (3) “Patient” means the individual to whom the licensee is rendering professional service. (4) “Sexual behavior” means: (a) A sexual act as specified in Criminal Law Article, §3-301(e) and (g), Annotated Code of Maryland; and (b) Sexual contact as specified in Criminal Law Article, §3-301(f), Annotated Code of Maryland. (5) “Sexual exploitation” means a situation in which the licensee takes advantage of the unequal relationship between the licensee and a patient, a student, or an employee to obtain sexual favors. (6) “Sexual harassment” means a deliberate or repeated comment, advance, gesture, solicitation, request, or physical contact of a sexual nature. #### Regulation .03 General Conduct. *COMAR 10.28.14.03* A. The licensee shall: (1) Apprise the patient of the risks, opportunities, and obligations associated with services available to the patient; (2) Make the fee for service clear, maintain adequate financial records, and confirm arrangements for financial reimbursement with the patient; (3) Notify the patient promptly and seek the transfer, referral, or continuation of service in relation to the patient's need or preference if the licensee anticipates the termination or interruption of service to the patient; (4) Obtain voluntary and informed consent from a patient for participation in research, without direct or implied deprivation or penalty for refusal to participate; (5) Inform the Board of unethical conduct by a licensed optometrist; and (6) Inform the Board about an individual who is not licensed by the Board but who represents that the individual is an optometrist and is practicing, attempting to practice, or offering to practice optometry. B. In the capacity of or identity as a licensed optometrist, the licensee may not: (1) Participate or condone dishonesty, fraud, deceit, or misrepresentation; (2) Misrepresent professional qualifications, education, experience, or affiliation; (3) Exploit a relationship with a patient for personal advantage or satisfaction; (4) Practice, condone, facilitate, or collaborate with discrimination on the basis of race, color, sex, sexual orientation, age, religion, national origin, marital status, political belief, mental or physical handicap, or other preference or personal characteristic, condition, or status; (5) Engage or participate in an action that violates or diminishes the civil or legal rights of a patient; or (6) Share a fee or accept or give something of value for receiving or making a referral. #### Regulation .04 Sexual Misconduct. *COMAR 10.28.14.04* A. An optometrist may not engage in sexual misconduct in the practice of optometry. B. Sexual misconduct includes, but is not limited to: (1) Sexual behavior with a client or patient in the context of a professional evaluation, treatment, procedure, or service to the client or patient, regardless of the setting in which the professional service is provided; (2) Sexual behavior with a client or patient under the pretext of diagnostic or therapeutic intent or benefit; (3) Requesting sexual favors of a client or patient; (4) Inappropriate touching of a client or patient in a sexual manner; (5) Therapeutically unnecessary discussion of sexual matters or other verbal conduct of a sexual nature while treating a patient; (6) Taking photographs or video tapes of a client or patient for sexual purposes; (7) Sexual harassment of staff or students; (8) Sexual exploitation; or (9) Inappropriate sexual language. C. Concurrent Sexual Relationships. The licensee may not engage in either consensual or forced sexual behavior with: (1) A patient; (2) A student or supervisor over whom the licensee exercises professional authority or with whom the licensee maintains direct supervision or education while the professional relationship continues to exist; or (3) An individual with whom the patient has a close personal relationship, including but not limited to a relative or a significant individual in the patient's life, if there is a risk of exploitation or potential harm to the patient. D. Relationships with Former Patients. (1) Except as set forth in §D(3) of this regulation, the licensee may not engage in sexual behavior with a former patient. (2) The licensee may not terminate professional services or a professional relationship with a patient in order to enter into a nonprofessional, social, or sexual relationship with the patient or an individual with whom the patient has a close personal relationship. (3) The licensee may enter into a relationship with an individual with whom the licensee's prior professional contact was of a brief, peripheral, consultative, or indirect nature, and did not constitute a therapeutic relationship. E. Prior Sexual Relationships. The licensee may not provide professional services to an individual with whom the licensee has previously engaged in sexual behavior. F. Sexual Harassment. (1) The licensee may not sexually harass a: (a) Patient; (b) Student; or (c) Employee. (2) If sexually harassed by a patient, the licensee shall: (a) Seek professional consultation with another licensed health professional; (b) Document all action taken in the patient's record; and (c) Terminate treatment and assist in a referral to another health care provider. G. Deceit During Evaluation, Treatment, Procedure, or Service. The licensee may not suggest, recommend, or encourage the patient to engage in a sexually provocative act, including but not limited to: (1) Sexual contact with the licensee; (2) Genital stimulation by or of the patient or licensee; (3) Undressing by or of the licensee in the presence of the patient, or of the patient in the presence of the licensee; and (4) Discussion or disclosure of a sexually provocative or erotic nature, not necessitated by treatment or treatment protocol. #### Regulation .05 Penalties. *COMAR 10.28.14.05* Violation of this chapter may result in the Board taking action to reprimand a licensee, place the licensee on probation, or suspend or revoke the licensee's license. The Board may also impose a penalty not exceeding $5,000. ### Chapter 15 — Compelling Purpose Disclosure **Authority:** General Provisions Article, §4-333; Health Occupations Article, §§11-205; Annotated Code of Maryland **Administrative History:** Effective date: January 7, 2002 (28:26 Md. R. 2273) #### Regulation .01 Scope. *COMAR 10.28.15.01* A. This chapter permits the Board to disclose investigative information to other agencies or other entities, or both, under certain circumstances. B. A custodian may disclose information in a certification, licensing, or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure. #### Regulation .02 Disclosure for Compelling Public Purpose. *COMAR 10.28.15.02* The custodian may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns: A. Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority; B. A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or C. Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges. #### Regulation .03 Other Disclosures. *COMAR 10.28.15.03* This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law. ### Chapter 16 — Selling and Dispensing of Contact Lenses **Authority:** Health-General Article, §24-301.1;Health Occupations Article, §§11-101, 11-205, and 11-404.4; Annotated Code of Maryland **Administrative History:** Effective date: January 16, 2006 (33:1 Md. R. 36) #### Regulation .01 Definitions. *COMAR 10.28.16.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Contact lens” means a medical device of any material or power, including plano or zero-powered, that is placed directly on: (a) The cornea; or (b) The cornea and sclera. (2) “Contact lens prescription” means “replacement contact lens prescription” as defined in Health Occupations Article, §11-404.4, Annotated Code of Maryland, and any federal statute and regulations that may supersede this Health Occupations citation. #### Regulation .02 Sales and Dispensing of Contact Lenses. *COMAR 10.28.16.02* Contact lens prescriptions and contact lenses are prescribed, sold, dispensed, and otherwise regulated as stated in Health Occupations Article, §11-404.4, Annotated Code of Maryland, and any federal statute and regulations that may supersede this Health Occupations citation. ### Chapter 17 — Disciplinary Sanctions and Monetary Penalties **Authority:** Health Occupations Article, §§1-606 and 11-314, Annotated Code of Maryland **Administrative History:** Effective date: October 1, 2012 (39:19 Md. R. 1237) #### Regulation .01 Scope. *COMAR 10.28.17.01* This chapter establishes standards for sanctions and monetary penalties not exceeding $5,000 against any optometrist in the State if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §11-314, Annotated Code of Maryland, to impose a sanction or monetary penalty. #### Regulation .02 Definitions. *COMAR 10.28.17.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Examiners in Optometry. (2) “License” means a license issued by the Board to practice optometry. (3) “Licensee” means an optometrist who is licensed by the Board to practice optometry. (4) “Penalty” means monetary penalty. (5) “Sanction” means a formal disciplinary action against a license such as a reprimand, probation, suspension, or revocation. #### Regulation .03 Imposition of a Penalty — General. *COMAR 10.28.17.03* Imposition of a Penalty After a Hearing. If, after a hearing under Health Occupations Article, §11-315, Annotated Code of Maryland, the Board finds that there are grounds under Health Occupations Article, §11-313, Annotated Code of Maryland, to suspend or revoke a license, the Board may impose a penalty as set forth in this chapter: A. Instead of, or in addition to, suspending the license; or B. In addition to revoking the license. #### Regulation .04 Guidelines for Disciplinary Sanctions and Imposition of Penalties. *COMAR 10.28.17.04* A. Subject to the provisions of this section, the Board may impose sanctions and penalties for violations of the Maryland Optometry Act and its regulations according to the guidelines set forth in the following chart: B. If a licensee is found in violation of more than one category enumerated in this chapter, the category or categories containing the highest maximum sanction and penalty shall prevail. C. Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and licensee may agree to a surrender of license or a consent order with terms, sanction, and penalty agreed to by the Board and the licensee. D. A departure from the guidelines set forth in this chapter alone is not grounds for any hearing or appeal of a Board action. #### Regulation .05 Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction. *COMAR 10.28.17.05* Depending upon the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following aggravating and mitigating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following: A. Mitigating Factors: (1) The licensee’s lack of a prior disciplinary record; (2) The licensee self-reported the violation to the Board; (3) The licensee’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings; (4) Implementation of remedial measures to correct or mitigate harm arising from the misconduct; (5) Timely good-faith effort to make restitution or to rectify consequences of misconduct; (6) Evidence of rehabilitation or rehabilitative potential; (7) Absence of premeditation to commit the misconduct; (8) Absence of potential harm or adverse impact to the public; and (9) The licensee’s conduct was an isolated incident and not likely to recur. B. Aggravating Factors: (1) The licensee has a previous criminal or administrative disciplinary history; (2) The violation was committed deliberately or with gross negligence or recklessness; (3) The violation had the potential for, or caused, serious patient or public harm; (4) The violation was part of a pattern of detrimental conduct; (5) The licensee was motivated to perform the violation for financial gain; (6) The vulnerability of the client or clients; (7) The licensee lacked insight into the wrongfulness of the conduct; (8) The licensee committed the violation under the guise of treatment; and (9) Previous attempts at rehabilitation of the licensee were unsuccessful. C. The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter. D. Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. #### Regulation .06 Payment of Penalty. *COMAR 10.28.17.06* A. A licensee shall pay to the Board a penalty imposed under this chapter as of the date the Board's order is issued, unless the Board's order specifies otherwise. B. Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §11-318, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter. C. If a licensee fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full. D. In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. E. The Board shall pay all monies collected under this chapter into the State's General Fund. ## Subtitle 29 — Board of Morticians and Funeral Directors ### Chapter 01 — Hearing Procedures **Authority:** Health Occupations Article, §§1-606, 7-205(a)(1) and (c), 7-316, 7-318, and 7-604, Annotated Code of Maryland **Administrative History:** Effective date: May 14, 1968 **Administrative History:** Preface amended effective December 15, 1986 (13:25 Md. R. 2660) **Administrative History:** Regulation .01 recodified to .01-1 and the Preface recodified to Regulation .01, July 1991 **Administrative History:** Chapter revised effective March 5, 2001 (28:4 Md. R. 418) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Chapter revised effective October 24, 2016 (43:21 Md. R. 1167) #### Regulation .01 Scope. *COMAR 10.29.01.01* A. This chapter governs procedures for disciplinary matters and hearings before the Maryland State Board of Morticians and Funeral Directors and establishes the standards for use as a guide for the imposition of disciplinary sanctions against any of the following under jurisdiction of the Board: (1) A licensed mortician, funeral director, apprentice, surviving spouse, funeral establishment, corporation, crematory supervisor, or executor; (2) A courtesy card holder; (3) A holder of a permit to operate a crematory; (4) A certified crematory operator or crematory technician; (5) A holder of a mortuary transport permit; and (6) A registered transporter. B. If, after a hearing, the Board finds that there are grounds under Health Occupations Article, §7–316 or 7–604, Annotated Code of Maryland, to sanction any person listed in §A of this regulation by way of probation, reprimand, suspension, fine, or revocation, the Board may consider aggravating and mitigating factors in determining sanctions. #### Regulation .02 Notice of Hearing. *COMAR 10.29.01.02* A. All interested parties shall be afforded an opportunity to be present at formal hearings. B. Written notice of the hearing shall be sent by the Secretary of the Board to all interested parties at least 30 days before the hearing. The notice shall state the date, time and place of the hearing. It shall also state the issues or charges involved in the proceeding. However, if by reason of the nature of the proceeding, the issues cannot be fully stated in advance of the hearing, or if subsequent amendment of the issue is necessary, they shall be fully stated as soon as practicable. #### Regulation .03 Parties and Representation. *COMAR 10.29.01.03* A. “Party” includes any person or agency named or admitted as a party, or properly seeking and entitled as of right to be admitted as a party, in formal hearings. Any person or agency may be admitted as a party for limited purposes. B. All parties appearing at formal hearings shall have the right to appear in proper person or by or with counsel. All parties shall have the right to be accompanied, represented and advised by counsel. #### Regulation .04 Prehearing Procedures. *COMAR 10.29.01.04* A. Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following: (1) A list of witnesses to be called; (2) Copies of documents intended to be produced at the hearing; or (3) Both. B. Mandatory Discovery. (1) Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier: (a) The name and curriculum vitae of any expert witness who will testify at the hearing; and (b) A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion. (2) If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §B of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert. (3) The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report: (a) At the prehearing conference, if scheduled; or (b) Immediately before the scheduled hearing. (4) If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §B of this regulation. C. Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation. D. Both parties have a continuing duty to supplement their disclosures of witnesses and documents. E. Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list after: (1) The prehearing conference, if scheduled; or (2) 15 days before the hearing, if no prehearing conference is scheduled. F. The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes. G. Construction. (1) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01. (2) In the event of a conflict between this regulation and COMAR 28.02.01, this regulation shall apply. #### Regulation .05 Records and Transcript. *COMAR 10.29.01.05* A. The Board shall prepare an official record, which shall include all pleadings, testimony, exhibits and other memoranda or material filed in the proceeding. B. Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board. The record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceeding, or part thereof, shall be paid by the party requesting the transcript. #### Regulation .06 Presiding Officer Duties. *COMAR 10.29.01.06* Each hearing shall be held before a quorum of the Board. The president, or in his absence a member designated by him, shall be the presiding officer, and shall have complete charge of the hearing, permit the examination of witnesses, admit evidence, rule on the admissibility of evidence, and adjourn or recess the hearing from time to time. #### Regulation .07 Order of Procedure. *COMAR 10.29.01.07* The order in which the parties shall present their case shall be determined by the presiding officer. #### Regulation .08 Examination of Witness and Introduction of Evidence. *COMAR 10.29.01.08* A. The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §§10-208 and 10-209, Annotated Code of Maryland. B. Any party may submit evidence, examine and cross-examine witnesses, and file objections, exceptions and motions. However, when a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions and motions shall be done and presented solely by the counsel. C. The presiding officer, or any person designated by him for the purpose, may examine any witness called by any party. He may call as a witness any person in attendance at the hearing. Any member of the Board may examine any witness called by any party. #### Regulation .09 Briefs. *COMAR 10.29.01.09* Any party may submit briefs of the issues of fact and law involved in the hearing. The briefs shall be filed in the form, with the number of copies, and at the time as the presiding officer may designate. #### Regulation .10 Sanctioning Guidelines. *COMAR 10.29.01.10* A. General Application. (1) This regulation shall be used by the Board as a guide for sanctioning pursuant to the Board’s authority under Health Occupations Article, §§7–205, 7–316, and 7–604, Annotated Code of Maryland, for violations of the Morticians and Funeral Directors Act and the Board’s regulations. (2) The Board is not required to make findings of fact with respect to any of the factors for determining the sanction indicated by the sanctioning guidelines. (3) A departure from the sanctioning guidelines alone is not a ground for any hearing or appeal of a Board action. (4) Notwithstanding these sanctioning guidelines, in order to resolve a disciplinary matter, the Board and the offending person may agree to surrender a license, courtesy card, permit, or certificate, or agree to a consent order with terms, conditions, and sanctions agreed upon. (5) In a case where there are multiple and distinct violations, the Board may impose a sanction greater than the maximum indicated by the sanctioning guidelines for each individual violation. (6) If probation is imposed, the Board may impose appropriate terms and conditions of probation. Violations of the terms or conditions may cause the Board to take further disciplinary action. (7) In the event a violation does not fall within the sanction range, the Board shall so indicate and use its best judgment to determine the appropriate sanction and consider, to the extent possible, the factors in the sanctioning guidelines. B. Range of Sanctions. C. Mitigating and Aggravating Factors. Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside of the range of sanctions established by the guidelines. These factors may include, but are not limited to the following: (1) Mitigating Factors: (a) Absence of a prior disciplinary record; (b) The respondent reported the violation to the Board; (c) The respondent voluntarily admitted violation, provided full disclosure to the Board, and cooperated during Board proceedings; (d) The respondent implemented remedial measures to correct or mitigate harm arising from the violation; (e) The respondent made a timely good-faith effort to make restitution or otherwise rectify the consequences of the violation; (f) Evidence of rehabilitation or potential for rehabilitation; (g) Absence of premeditation to commit the violation; (h) Absence of potential harm to or adverse impact on the public or adverse impact on the public; (i) Isolated incident and not likely to recur; and (j) The respondent’s prior community service and present value to the community. (2) Aggravating Factors: (a) Previous criminal or administrative disciplinary history; (b) The violation was committed deliberately or with gross negligence or recklessness; (c) The violation had the potential for, or caused, serious harm; (d) The violation was part of a pattern of detrimental conduct; (e) The respondent was motivated to perform the violation by the respondent’s financial gain; (f) The vulnerability of the bereaved; (g) The respondent attempted to conceal the violation, falsified or destroyed evidence, or presented false testimony or evidence; (h) The respondent failed to cooperate with the Board’s investigation; and (i) Previous attempts at rehabilitation were unsuccessful. #### Regulation .11 Counsel to the Board. *COMAR 10.29.01.11* The presiding officer may request the Office of the Attorney General to participate in any hearing as counsel for the Board. Upon that request, the counsel shall have all of the rights with regard to the submission of evidence, examination and cross-examination. #### Regulation .12 Decision and Order. *COMAR 10.29.01.12* Every decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law. The findings of fact shall consist of a concise statement of the conclusions upon each contested issue of fact. A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or his attorney of record. #### Regulation .13 Rehearings. *COMAR 10.29.01.13* A. Any party aggrieved by the decision and order rendered in the particular case may apply for rehearing within 10 days after service on him of the decision and order. Action on the application shall lie in the discretion of the Board. B. Unless otherwise ordered, neither the rehearing nor the application for rehearing shall stay the enforcement of the order or excuse the persons affected by it for failure to comply with its terms. C. The Board may, on rehearing, consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order. ### Chapter 02 — Examination **Authority:** Health Occupations Article, §7-304, Annotated Code of Maryland **Administrative History:** Effective date: May 4, 1987 (14:9 Md. R. 1080) **Administrative History:** Regulation .01B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03C amended effective January 8, 2024 (50:26 Md. R. 1131) **Administrative History:** Regulation .04 amended effective May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .06A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) #### Regulation .01 Definitions. *COMAR 10.29.02.01* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means any individual who qualifies to take the Maryland mortician or funeral director examination. (2) “Board” means the State Board of Morticians and Funeral Directors. (3) “Maryland mortician and funeral director examination” means the legal and practical examination that is given by the Board to test the competency of individuals applying for a Maryland mortician or funeral director license. #### Regulation .02 Scope of Examination. *COMAR 10.29.02.02* The Board will give a two-part examination which consists of a: A. Legal part, testing the applicant's knowledge of Maryland law and regulations governing mortuary science, including subject areas disclosed to applicants as part of a notification of the upcoming examination sent to all licensed apprentices and other applicants; and B. One of the following: (1) Practical part for morticians, testing competency in embalming and otherwise preserving a dead human body, as specified in Health Occupations Article, §7-304(d)(1)(i) and (ii), Annotated Code of Maryland; or (2) Practical part for funeral directors, testing competency in hazardous waste and washing and handling a dead human body. #### Regulation .03 Requirements for Examination. *COMAR 10.29.02.03* An applicant shall: A. Hold an apprentice license or have completed the apprenticeship requirements; B. Submit an application for examination on the required form; and C. Pay to the Board the examination fee set forth under COMAR 10.29.04.02A. #### Regulation .04 Passing Score. *COMAR 10.29.02.04* A. A minimum passing grade of 75 percent is required on the: (1) Law examination; (2) Practical examination. B. An applicant who fails either part of the examination may retake that part of the examination one time during the next examination period without paying an additional $100 fee. C. An applicant who fails both parts of the examination may retake the entire examination one time during the next examination period without paying an additional $100 fee. D. The Board shall notify each applicant by mail of the results of the examination within 45 days after it is taken. Numerical scores may not be given out unless requested in writing by the applicant. #### Regulation .05 Frequency of Examination. *COMAR 10.29.02.05* The Board shall hold an examination twice a year, in April and October. #### Regulation .06 National Examination. *COMAR 10.29.02.06* A. Before granting a Maryland mortician or funeral director license, the Board shall require an applicant to take and pass the national examination administered by the Conference of Funeral Service Examining Boards of the United States. The national examination may be taken either before or after the applicant takes the Maryland examination. An applicant may retake the national examination as often as is necessary to fulfill this requirement. B. A minimum passing grade of 75 percent on each section of the examination is required. C. The two sections of the examination are: (1) Funeral service science, which includes: (a) Embalming; (b) Restorative art; (c) Microbiology; (d) Pathology; (e) Chemistry; and (f) Anatomy; (2) Funeral service arts, which includes: (a) Sociology of funeral service; (b) Psychology and counseling; (c) Funeral directing and professional relationships; (d) Business law; (e) Funeral service law; (f) Funeral merchandising; and (g) Accounting. ### Chapter 03 — Inspection of Funeral Establishments **Authority:** Health Occupations Article, §§7-101, 7-205, and 7-310, Annotated Code of Maryland **Administrative History:** Effective date: January 20, 1992 (19:1 Md. R. 32) **Administrative History:** Regulation .04D amended effective November 29, 1999 (26:24 Md. R. 1858) **Administrative History:** Chapter revised effective November 26, 2001 (28:23 Md. R. 2054) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02B amended effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03H amended effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .03H amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03H amended effective September 7, 2009 (36:18 Md. R. 1380) **Administrative History:** Regulation .04B amended effective September 7, 2009 (36:18 Md. R. 1380) **Administrative History:** Regulation .04C amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .04E amended effective November 24, 2014 (41:23 Md. R. 1372) **Administrative History:** Regulation .08C adopted effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .08C amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Chapter revised effective April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .03 amended effective January 8, 2024 (50:26 Md. R. 1131) #### Regulation .01 Scope. *COMAR 10.29.03.01* The purpose and intent of this chapter is to prescribe minimum standards for new and existing funeral establishments, renovations of existing funeral establishments, restricted funeral establishments, and change of ownership of funeral establishments where the practice of mortuary science or funeral direction is conducted. #### Regulation .02 Definitions. *COMAR 10.29.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland State Board of Morticians and Funeral Directors. (2) “Deficiency” means a specific failure to comply with the requirements set forth by the Board. (3) “Funeral director” means an individual who is licensed by the Board to practice all aspects of mortuary science, except for embalming. (4) “Funeral establishment” means any building, structure, or premises licensed by the Board, with facilities for: (a) Embalming or holding of human remains for disposition; (b) Viewing of the human remains; and (c) Funeral services. (5) “Funeral establishment sponsor” means any licensed funeral establishment providing for the operation of a Board-approved restricted funeral establishment. (6) “Holding room” means a room which is: (a) Used for the holding of human remains if arterial embalming is not a function of the funeral establishment; and (b) Distinct from the viewing room, chapel, or any other part of a funeral establishment. (7) “Inspection” means a survey of a funeral establishment by an inspector designated by the Board to ensure compliance with this chapter. (8) “Mortician” means an individual who is licensed by the Board to practice mortuary science. (9) “Ownership” means having or controlling directly or indirectly at least 10 percent interest in the corporation, partnership, association, organization, or other business entity. (10) Practice Funeral Direction. (a) “Practice funeral direction” means to: (i) Operate a funeral establishment; (ii) For compensation, prepare human remains for disposition; and (iii) For compensation, arrange for or make final disposition of human remains. (b) “Practice funeral direction” does not include: (i) For compensation, disinfecting or preserving human remains or any of its parts by arterial or cavity injection or any other type of preservation; or (ii) The business of operating a crematory. (11) Practice Mortuary Science. (a) “Practice mortuary science” means: (i) The practice of funeral direction; and (ii) Disinfecting or preserving human remains or any of its parts by arterial or cavity injection. (b) “Practice mortuary science” does not include: (i) The pickup, removal, or transportation of human remains, if the unlicensed individual is acting under the direction of a licensed mortician or funeral director; or (ii) The business of operating a crematory. (12) “Preneed contract” means an agreement between a consumer and a licensed funeral director or licensed mortician to provide any goods and services purchased before the time of death. (13) “Preparation room” means an area with a minimum of 120 square feet which is used exclusively for the practice of mortuary science, which is separate and distinct from the viewing room, chapel, or any other part of a funeral establishment. (14) “Restricted funeral establishment” means a licensed business authorized by the Board under Health Occupations Article, §7-310(a)(2), Annotated Code of Maryland, to practice mortuary science or funeral direction services by a licensed mortician or funeral director with a designated sponsoring funeral establishment. (15) “Supervising funeral director” means a funeral director who is responsible to the Board for compliance with Health Occupations Article, Title 7, Annotated Code of Maryland, for all operations of a funeral establishment including, but not limited to, the administration of preneed accounts. (16) “Supervising mortician” means a mortician who is responsible to the Board for compliance with Health Occupations Article, Title 7, Annotated Code of Maryland, for all operations of a funeral establishment including, but not limited to, the administration of preneed accounts. (17) “Viewing room” means an area in which human remains are placed on display and which is a separate and distinct area from the preparation and holding room. #### Regulation .03 Funeral Establishment Requirements. *COMAR 10.29.03.03* A. The Board shall license a funeral establishment before the funeral establishment may be used for the practice of mortuary science or funeral direction. B. The Board shall issue a funeral establishment license to a funeral establishment that has: (1) Complied with all applicable federal, State, and local laws, including the requirements set forth in this chapter; (2) Except as provided in §C of this regulation, completed all requirements specified in this chapter within 6 months of application submission; (3) Submitted an application to the Board on the required form at least 60 days before the opening of the business; (4) Paid the non-refundable application fee and, when applicable, the family security trust fund fee; and (5) Operated in accordance with Health Occupations Article, Title 7, Annotated Code of Maryland. C. Application Extension Request. To obtain approval from the Board for an application extension, a funeral establishment shall: (1) Submit, in writing to the Board, a one-time application extension request not to exceed 90 days; and (2) Explain the reason for the extension request. D. A license shall expire on the date set by the Board, unless the license is renewed for an additional term at a fee set by the Board. E. A license is nontransferable and may not be renewed for a term longer than 2 years. F. Upon a sale or change in ownership of the funeral establishment, the new owner shall: (1) Notify the Board within 14 days; and (2) Request a new license by submitting an application to the Board in writing with supporting documentation reflecting the sale or change of ownership. G. The Board shall issue a new funeral establishment license reflecting the sale or change in ownership if: (1) The applicant submits the required documentation to the Board; and (2) An inspection of the funeral establishment results in a finding that the funeral establishment is in compliance with all applicable federal, State, and local laws. H. A license, and the licenses of individual licensees employed at the funeral establishment, shall be displayed prominently at the premises. I. The funeral establishment: (1) Shall employ and designate, on a form provided by the Board, a supervising mortician or supervising funeral director, licensed in accordance with State laws, who shall be in compliance with Health Occupations Article, Title 7, Annotated Code of Maryland; (2) Shall prominently display on a sign, not smaller than 8 and 1/2 inches by 11 inches, immediately located either outside or inside the main entrance, in letters not less than one-half inch high, the names of: (a) Each licensee who holds at least a 10 percent ownership interest in the partnership, professional association, or sole proprietorship which operates the funeral establishment; (b) Any individual, corporation, or other business entity, which either directly or indirectly holds an ownership interest of 10 percent or more in the corporation or business entity that operates the funeral establishment; and (c) All restricted funeral establishments operating from that funeral establishment; (3) That does embalmings and has designated a funeral director as the supervising agent shall employ a licensed mortician on staff; (4) May not be required to apply for a new funeral establishment license if there is a change of a supervising mortician or supervising funeral director; (5) Shall notify the Board, on a form provided by the Board, of any change of supervising mortician or supervising funeral director within 10 days; (6) May not operate without a supervising mortician or supervising funeral director, who shall be continuously responsible, for more than 30 calendar days; and (7) Shall ensure that medical waste is picked up by a licensed medical waste disposer not less than every 60 days from the date generated as outlined in COMAR 10.06.06. #### Regulation .04 Restricted Funeral Establishment Requirements. *COMAR 10.29.03.04* A. The Board shall license a restricted funeral establishment before the restricted funeral establishment may be used for the practice of mortuary science or funeral direction. B. The Board shall issue a restricted funeral establishment license to a restricted funeral establishment that has: (1) Complied with: (a) All applicable federal, State, and local laws; (b) Advertising requirements set forth in COMAR 10.29.12; and (c) Regulation .05 of this chapter; (2) For each restricted funeral establishment: (a) Submitted an application to the Board on the required form which includes a full description of services; (b) Paid the application fee and, when applicable, the family security trust fund fee; and (c) Completed and passed an inspection as outlined in Regulation .05 of this chapter; (3) After July 1, 2001, submitted to the Board copies of the documents listed in Regulation .05D of this chapter; (4) Beginning January 1, 2002, submitted during the bi-annual inspection to the Board, copies of the documents listed in Regulation .05D of this chapter created during the preceding year; and (5) Operated in accordance with Health Occupations Article, Title 7, Annotated Code of Maryland. C. The restricted funeral establishment shall: (1) Submit a notarized lease agreement with the sponsoring funeral establishment, including an application stating scope of operations for approval to the Board; (2) Employ and designate, on a form provided by the Board, a supervising mortician or supervising funeral director, licensed in accordance with State laws, who shall be in compliance with Health Occupations Article, Title 7, Annotated Code of Maryland; and (3) Submit documentation of any termination or change in the status of the lease agreement, within 10 days of the termination or change in status. D. Subject to the hearing provisions of Health Occupations Article, §7-319, Annotated Code of Maryland, the Board may: (1) Deny a license to an applicant for a restricted funeral establishment license; (2) Reprimand the holder of a restricted funeral establishment license; (3) Place the holder of a restricted funeral establishment license on probation: (4) Suspend or revoke a restricted funeral establishment license if, with the knowledge or at the direction of the restricted funeral establishment: (a) An unlicensed individual practices mortuary science or funeral direction for or within the restricted funeral establishment; or (b) An employee of the restricted funeral establishment fails to comply with: (i) Health-General Article, §5-513(b) and (d), Annotated Code of Maryland; and (ii) Health Occupations Article, §7-405, Annotated Code of Maryland. E. The funeral establishment sponsor shall remain in good standing with the Board to continue as a sponsor for any restricted funeral establishment. F. For a funeral establishment sponsor that experiences the death of single owner and sole licensee as set forth in Health Occupations Article, §7-308.3, Annotated Code of Maryland, the restricted funeral establishment: (1) Shall submit to the Board a new notarized lease agreement within 30 days, if the restricted funeral establishment intends to continue operating from that sponsoring funeral establishment; (2) Shall be subject to hearing provisions set forth under Health Occupations Article, §7-319, Annotated Code of Maryland, for failure to comply with §F(1) of this regulation, which may result in: (a) A reprimand for the holder of the restricted establishment license; (b) Probation for the holder of the restricted establishment license; or (c) The suspension or revocation of the restricted establishment license; and (3) May voluntarily surrender the restricted funeral establishment license to avoid the hearing procedures provided the conditions are met as set forth under Health Occupations Article, §7-318, Annotated Code of Maryland. G. If a funeral establishment sponsor closes its operations to the public, any restricted establishment license with a lease agreement with this designated funeral establishment sponsor: (1) Shall become invalid upon closure of the sponsoring funeral establishment subject to the hearing provisions set forth under Health Occupations Article, §7-319, Annotated Code of Maryland; or (2) May voluntarily surrender the restricted funeral establishment license to avoid the hearing procedures, provided the conditions are met as set forth under Health Occupations Article, §7-318, Annotated Code of Maryland. H. For each location operated by the restricted funeral establishment, a separate license shall be obtained and displayed prior to commencing the practice of mortuary science or funeral direction. I. As set forth under Health Occupations Article, §7-504, preneed services and merchandise may be offered by a restricted funeral establishment. #### Regulation .05 Inspection by the Board. *COMAR 10.29.03.05* A. A licensed funeral establishment and a restricted funeral establishment shall be open at all reasonable times for inspection by the Board. Inspection results shall be written on forms approved by the Board. B. Each funeral establishment and restricted funeral establishment shall be inspected: (1) On a biennial basis; (2) In furtherance of an investigation; or (3) Upon the sale or change of ownership of the funeral establishment. C. An owner, supervising mortician, supervising funeral director, or licensed designee shall be available to accompany the inspector during the inspection and sign the inspection report. D. The following forms shall be available for inspection, with a copy given to the inspector for the inspector's records: (1) A general price list of charges for services to the public; (2) A completed and duly signed funeral service contract with any invoices attached; (3) A price list of caskets as charged to the public; (4) A price list of outer burial containers, as charged to the public; (5) Cremation forms: (a) Authorization form to cremate; (b) Cremation identification form; and (c) Disposition of cremated remains notification; (6) A preneed contract form along with a bank statement form, for verification of an escrow or trust account, and, if provided, an insurance statement; (7) A copy of the hazardous waste certification form described in §E(6)(d) of this regulation; and (8) An authorization to release the body to the funeral establishment or the restricted funeral establishment. E. Standards for Inspection of Funeral Establishments and Restricted Funeral Establishments. (1) Preparation Room. If arterial or cavity injection will take place at a funeral establishment or a restricted funeral establishment, the funeral establishment or the restricted funeral establishment shall maintain on the premises a preparation room which shall be adequately equipped and maintained in a sanitary manner for the preservation and care of human remains. The minimal requirements shall be as follows: (a) The floors, walls, and ceilings shall be smooth and made of tile or other high gloss, impervious, washable material; (b) The floors, walls, and ceilings shall be in a clean and sanitary condition; (c) The lighting shall be adequate; (d) The ventilation shall be in accordance with current Occupational Safety and Health Administration (OSHA) regulations; (e) Doors to the preparation room shall be tight-closing and the windows maintained to obstruct any view into the preparation room; (f) The preparation room shall be a minimum of 120 square feet; and (g) If a refrigeration unit is on the premises, it shall be clean, sanitary, and in good working condition. (2) Holding Room. If arterial or cavity injection will not take place at a funeral establishment or a restricted funeral establishment, the funeral establishment or the restricted funeral establishment shall maintain on the premises a holding room which shall be adequately equipped for the holding of human remains which shall be kept in a clean and sanitary manner. The minimal requirements for the holding room shall be as follows: (a) The floors, walls, and ceilings shall be smooth and made of tile or other high gloss, impervious, washable material; (b) The floors, walls, and ceilings shall be in a clean and sanitary condition; (c) The lighting shall be adequate; (d) An exhaust system whereby gases would be drawn to outside air shall be the minimum standard for holding rooms in funeral establishments where embalming does not take place; (e) Doors to the holding room shall be tight-closing and the windows maintained to obstruct any view into the holding room; and (f) The holding room shall be a minimum of 120 square feet. (3) Instruments and Equipment. (a) Instruments shall be autoclaved, steamed, or cleaned with a chemical disinfectant commonly used in the industry. (b) The preparation table shall have a nonporous surface. (c) The removal stretcher and litter shall have a waterproof pouch. (d) If a refrigeration unit is on the premises, it shall be clean, sanitary, and in good working condition. (4) Water Supply. (a) Each funeral establishment and restricted funeral establishment shall have hot and cold running water. (b) The drain pipe for the water supply shall be at least 2 inches in diameter. (c) Floor drainage is required in the preparation room of a funeral establishment where embalming takes place, except for an establishment that existed on or before November 26, 2001 that has not had after that date: (i) The preparation room renovated; or (ii) A change of ownership. (5) Chemicals. All chemicals shall be plainly marked with appropriate warning labels. (6) Waste. (a) The preparation room shall be equipped with covered waste receptacles. (b) Infectious waste shall be clearly identified and separate from other waste and put in a rigid container. (c) Blood and waste shall be disposed of in accordance with COMAR 10.06.06.01—.08. (d) A copy of the hazardous waste certification form provided by the licensee's hazardous waste contractor shall be provided to the Board's inspector. (e) The removal vehicle shall contain a universal precaution kit which shall contain at least: (i) Disposable gloves; (ii) Antibacterial hand wipes; and (iii) A hazardous waste container for the proper disposal of wastes. (7) Removal Vehicle. The removal vehicle shall be suitable for the transportation of human remains obscured from public view and maintained in a sanitary manner. (8) Funeral Service Establishment and Restricted Funeral Establishment Premises. (a) The remaining areas of the funeral establishment and the restricted funeral establishment shall be in good repair, clean, and safe. (b) If a funeral establishment or a restricted funeral establishment has a memorial gathering area, it shall be: (i) In good repair; (ii) Clean; and (iii) At least 300 square feet in area. (c) If a funeral establishment or a restricted funeral establishment displays any form of casket selection, the prices shall also be shown. (d) The inspection shall assess the general cleanliness of the funeral establishment and the restricted funeral establishment and whether there are properly functioning, sanitary restrooms. (e) The business telephone shall be in working order at a funeral establishment and a restricted funeral establishment. (f) A sign or lettering on the windows or building indicating the name of the funeral establishment and the restricted funeral establishment shall be conspicuously displayed, and the name on the sign shall be the same name on the funeral establishment license and the restricted funeral establishment license. (g) If one or more businesses, in addition to a funeral establishment, are operating on the same premises, a separate sign shall indicate the entrance and exit of the funeral establishment and the restricted funeral establishment. F. After the inspection is completed, an exit interview shall be conducted to apprise the owner or supervising mortician of the findings of the inspection. A copy of the inspection report shall be left with the owner or supervising mortician who shall verify receipt of the inspection report. #### Regulation .06 Establishment Inspection Report and Deficiencies. *COMAR 10.29.03.06* A. The Board shall review the inspection report and make a determination as to whether a deficiency exists. B. The Board shall notify the funeral establishment and the restricted funeral establishment in writing of the results of the inspection. C. If the funeral establishment licensee and the restricted funeral establishment licensee pass the inspection, the licensees shall prominently display on the premises a statement issued by the Board that the funeral establishment and the restricted funeral establishment have successfully passed the inspection. D. If the Board finds a deficiency, the Board shall send to the owner and the restricted funeral establishment within 2 weeks of the inspection notification of the deficiency or failure to pass the inspection. E. Correction of Deficiency. (1) Except as provided in this section, an owner and the restricted funeral establishment shall correct a deficiency within 30 days after receipt of notification. (2) The Board may require immediate correction of a deficiency if the Board considers the correction necessary to the interest of public health. (3) The owner or the restricted funeral establishment may request an extension of time for correction of a deficiency. (4) The Board may approve an extension of time for correction of a deficiency. (5) Upon completion of correction of all deficiencies, the owner or the restricted funeral establishment shall notify the Board. (6) Upon notification, the Board or its designee shall re-inspect the funeral establishment or the restricted funeral establishment and the Board shall notify the owner or the restricted funeral establishment in writing of the results of the re-inspection within 1 week. (7) If re-inspection reveals additional deficiencies not cited in the first inspection report, the owner or the restricted funeral establishment shall correct those deficiencies in the time period specified unless an extension of time is requested by the owner or the restricted funeral establishment and approved by the Board. #### Regulation .07 Penalties. *COMAR 10.29.03.07* A. Failure to allow an inspection of the funeral establishment or the restricted funeral establishment may result in disciplinary action against a funeral establishment license or a restricted funeral establishment license, subject to the hearing requirements as set forth under Health Occupations Article, §7-319, Annotated Code of Maryland. B. Failure to comply with a notice to correct deficiencies or violations within the 30-day period, or any reasonable extension granted by the Board under Regulation .06E of this chapter, may result in disciplinary action against a funeral establishment license or the denial of a renewal of a funeral establishment license, subject to the hearing requirements as set forth under Health Occupations Article, §7-319, Annotated Code of Maryland. C. Disciplinary action may not be taken against a supervising mortician or funeral director for the acts or omissions of another individual unless the supervising mortician or funeral director knew or should have known of a violation of: (1) Health-General Article, Title 5, Annotated Code of Maryland; or (2) Health Occupations Article, Title 7, Annotated Code of Maryland. ### Chapter 04 — Fee Schedule **Authority:** Health Occupations Article, §§7-205, 7-206, 7-303(b)(6), 7-304(e), 7-305(b)(1), 7-306(c), 7-308(a)(4), 7-308.1, 7-309(b)(4), 7-310(b)(1)(ii), 7-311(a)(4), 7-314(c)(2), 7-315(a)(3), and 7-321, Annotated Code of Maryland **Administrative History:** Effective date: May 11, 1992 (19:9 Md. R. 879) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02 amended effective September 27, 1993 (20:19 Md. R. 1472) **Administrative History:** Regulation .02 amended as an emergency provision effective November 18, 1994 (21:25 Md. R. 2093); amended permanently effective February 13, 1995 (22:3 Md. R. 154) **Administrative History:** Regulation .02 amended effective November 16, 2009 (36:23 Md. R. 1817) **Administrative History:** Regulation .02A amended as an emergency provision effective March 1, 2001 (28:4 Md. R. 415); amended permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulation .02A amended as an emergency provision effective October 1, 2002 (29:16 Md. R. 1285); amended permanently effective October 28, 2002 (29:21 Md. R. 1646) **Administrative History:** Regulation .02A amended as an emergency provision effective January 1, 2004 (31:4 Md. R. 313); amended permanently effective March 29, 2004 (31:6 Md. R. 509) **Administrative History:** Regulation .02A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03 amended effective September 27, 1993 (20:19 Md. R. 1472); January 8, 2024 (50:26 Md. R. 1131) **Administrative History:** Regulation .03A amended as an emergency provision effective March 1, 2001 (28:4 Md. R. 415); amended permanently effective May 14, 2001 (28:9 Md. R. 885) **Administrative History:** Regulation .03A amended as an emergency provision effective October 1, 2002 (29:16 Md. R. 1285); amended permanently effective October 28, 2002 (29:21 Md. R. 1646) **Administrative History:** Regulation .03B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) #### Regulation .01 Scope. *COMAR 10.29.04.01* This chapter governs all persons licensed by the Board of Morticians and Funeral Directors in Maryland. #### Regulation .02 Fees. *COMAR 10.29.04.02* The following fees are established by the Board: A. Mortician and Funeral Director examination fee ... $265; B. Mortician license, initial fee ... $600; C. Mortician license, renewal fee ... $600; D. Apprenticeship license, initial fee ... $325; E. Apprenticeship license, renewal fee ... $325; F. Corporation license, renewal fee ... $975; G. Establishment license, initial fee ... $700; H. Establishment license, renewal fee ... $700; I. Funeral director license, initial fee ... $600; J. Funeral director license, renewal fee ... $600; K. Executor license fee ... $250; L. Surviving spouse license, initial fee ... $600; M. Surviving spouse license, renewal fee ... $600; N. Courtesy card license, initial fee ... $600; O. Courtesy card license, renewal fee ... $600; P. Late license fee—payable if renewal fee is received more than 15 days after the expiration date ... $400; Q. Reinstatement fee—payable after failure to renew the license within 5 years of the date of expiration ... $600; R. Inactive status fee ... $300; S. Inactive status renewal fee ... $300; T. Reactivation of license fee ... $300; U. Continuing education vendor fee ... $100; V. Duplicate Wall Certificate ... $50; W. Duplicate License ... $35; X. Licensure Verification / Certification ... $40; Y. Failure to notify the Board within 30 days of an address change ... $50; Z. Returned check fee ... $40; AA. Establishment name change ... $150; BB. Non-compliance inspection fee, first offense ... $50; CC. Non-compliance inspection fee ... $100. #### Regulation .03 Terms. *COMAR 10.29.04.03* A. Licensees shall pay to the Board of Morticians the fees set forth in: (1) Regulation .02C of this chapter by April 30 of every year ending with an even number; (2) Regulation .02E of this chapter annually; (3) Regulation .02F, I, L, and N of this chapter by November 30 of every year ending with an even number; and (4) Regulation .02H of this chapter by November 30 of every year ending with an even number; B. The Board of Morticians and Funeral Directors shall prorate the fees set forth in Regulation .02A, B, G, H, J, and L of this chapter in 1-year intervals until the date of expiration. C. All application fees are non-refundable. ### Chapter 05 — Continuing Education **Authority:** Health Occupations Article, §§7-205 and 7-314(c)(4), Annotated Code of Maryland **Administrative History:** Effective date: December 5, 1994 (21:24 Md. R. 1988) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03 amended effective February 8, 2010 (37:3 Md. R. 176) **Administrative History:** Regulation .04A, D amended effective February 8, 2010 (37:3 Md. R. 176) **Administrative History:** Regulation .05 amended effective January 7, 2002 (28:26 Md. R. 2273); September 7, 2009 (36:18 Md. R. 1380); February 8, 2010 (37:3 Md. R. 176) **Administrative History:** Regulation .05J amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154);amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .06A amended effective September 7, 2009 (36:18 Md. R. 1380) **Administrative History:** Regulation .06D amended effective March 27, 1995 (22:6 Md. R. 474) #### Regulation .01 Scope. *COMAR 10.29.05.01* This regulation governs a person practicing as a mortician, funeral director, or holder of a surviving spouse license in Maryland. #### Regulation .02 Definitions. *COMAR 10.29.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Morticians and Funeral Directors. (2) “Continuing education unit (CEU)” means 50 clock minutes of educational instruction in a Board-approved continuing education program. (3) “Funeral director” means an individual who is licensed by the Board to practice all aspects of mortuary science except for embalming. (4) “Mortician” means an individual who practices mortuary science. (5) “Surviving spouse” means the legal widow or widower of a licensed funeral director or licensed mortician, whose license was in good standing at the time of death, and who, at the time of death, wholly or partly owned and operated a mortuary science business. #### Regulation .03 Standards of Continuing Education Preapproval. *COMAR 10.29.05.03* A. Continuing education units are automatically approved and do not need to be submitted to the Board if the programs are: (1) Approved by the Academy of Funeral Service Practitioners; (2) Sponsored by national service organizations; (3) Sponsored by State associations; (4) Sponsored by local associations; (5) Provided by suppliers; or (6) Already approved by the Board. B. Licensed Maryland funeral establishments and other Maryland licensees may apply to the Board for CEU approval. C. A continuing education course or workshop may be qualified for approval if the Board determines that it: (1) Constitutes an organized program of learning, including a symposium, which contributes directly to the professional competency of the licensee; (2) Is related to the practice of mortuary science; (3) Is conducted by individuals considered experts in the subject matter of the program by reason of education, training, or experience; and (4) Is accompanied by a paper, manual, or written outline which substantially describes the subject matter of the program. D. An individual seeking to conduct a seminar, workshop, or presentation shall submit for Board approval at least 6 weeks in advance of the proposed seminar, workshop, or presentation the following: (1) Documentation indicating the number of CEUs that will be proposed; (2) A description of the course; (3) Qualifications of the presenter; (4) A course outline; and (5) Any manuals or other documents to be distributed. #### Regulation .04 Post-Approval and Review. *COMAR 10.29.05.04* A. Each licensee seeking credit for attendance and participation in an education program that is not preapproved shall submit to the Board, within 30 days after completion of the activity, the following: (1) Activity's dates; (2) Subjects covered; (3) Names of instructors and their qualifications; and (4) Number of CEUs requested. B. Within 90 days after receipt of the application, the licensee shall be advised by the board, in writing, as to whether the activity is approved and the number of CEUs allowed. C. A licensee may be denied credit if the licensee fails to comply with the requirements of this regulation. D. A continuing education course or workshop that is already approved may be monitored or reviewed by the Board, and, upon evidence of significant variation in the program presented from the program approved, all or any part of the approved hours granted the program may be disapproved. #### Regulation .05 Continuing Education Requirements. *COMAR 10.29.05.05* A. The following licensees, except as otherwise stated, at the time of renewal, shall submit documentation of continuing education in the field of mortuary science to the Board: (1) Morticians; (2) Funeral directors; and (3) Surviving spouses. B. The morticians, funeral directors, and surviving spouses may begin to accumulate CEUs beginning May 1, 1994 for the renewal period of April 1996 for morticians and November 1997 for funeral directors and surviving spouses. C. Except as provided in this regulation, each licensee in the State shall submit, with the license renewal application, a list of a minimum of 12 CEUs each renewal period of continuing education course work approved by continuing education providers as set forth in Regulation .03 of this chapter, or the Board. The Board shall undertake a random audit of a certain percentage of licensees to determine CEU compliance. D. CEUs may be obtained by attending and participating in continuing education courses or workshops previously approved by the Board or otherwise meeting the requirements and approved by the Board. E. During the time an organization, educational institution, or person is an approved sponsor, all continuing education programs of the organization, educational institution, or person may be approved by the Board. F. The Board shall waive continuing education requirements for individuals newly licensed for the first-time renewal of a license. G. Except as allowed by the Board, a licensee may not receive credit exceeding nine CEUs of the biennial total required: (1) For correspondence work; (2) For video, sound-recorded, or television programs; or (3) By information transmitted by other similar means as authorized by the Board. H. Service as a lecturer or discussion leader may be included to the extent that it contributes to the professional competency of the applicant, but repetitious presentations may not be counted and not more than 50 percent of the total required CEUs may be satisfied in this manner. I. The maximum number of CEUs which may be granted for any single continuing education course or workshop single topic is six. J. A licensee may not receive more than three CEUs within a renewal period for attending a Board of Morticians and Funeral Directors board meeting. K. A licensee may obtain three CEUs for any business courses completed and approved by continuing education providers set forth in Regulation .03 of this chapter, or the Board. L. After the renewal period beginning May 1, 2008 for morticians, and December 1, 2008 for funeral directors and surviving spouse licensees, 3 carry-over credits may be granted per renewal cycle. M. A licensee shall earn a minimum of 1 CEU hour in an approved course on preneed law per renewal cycle. #### Regulation .06 Exemptions. *COMAR 10.29.05.06* A. The Board shall grant an exemption from meeting the continuing education requirements to a licensed mortician, funeral director, or surviving spouse license holder who has practiced mortuary science in the State for 40 years and has submitted a one-time request for an exemption to the Board at the time of license renewal. B. The Board shall consider a waiver of all or part of the continuing education requirements on a case-by-case basis for a licensed mortician, funeral director, or surviving spouse license holder based on documentation of disability or unusual circumstances. C. A mortician, funeral director, or surviving spouse licensee whose license is on an inactive status is not required to meet the continuing education requirements. D. Upon reactivation of an inactive license, a mortician, funeral director, or surviving spouse shall submit documentation of CEUs for the current renewal period in which the license is reactivated. ### Chapter 06 — Preneed Contract **Authority:** Health Occupations Article, §§7-404, 7-405, and 7-504, Annotated Code of Maryland **Administrative History:** Effective date: September 26, 1994 (21:19 Md. R. 1635) **Administrative History:** Regulation .02B amended effective March 18, 2002 (29:5 Md. R. 504); August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02B amended effective April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .03 amended effective March 18, 2002 (29:5 Md. R. 504); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .03A amended effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .03H, I adopted effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .04 amended effective March 18, 2002 (29:5 Md. R. 504) **Administrative History:** Regulation .04A amended effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .04F adopted effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .05 amended effective March 18, 2002 (29:5 Md. R. 504) **Administrative History:** Regulation .05A amended effective August 27, 2007 (34:17 Md. R. 1508) **Administrative History:** Regulation .05E, F adopted effective August 27, 2007 (34:17 Md. R. 1508) #### Regulation .01 Scope. *COMAR 10.29.06.01* These regulations apply to all preneed contracts entered into by a licensed mortician, a licensed funeral director, and a holder of a surviving spouse license with a buyer. #### Regulation .02 Definitions. *COMAR 10.29.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “At need” means funeral arrangements made after the death of an individual by one authorized to make those arrangements. (2) “Beneficiary” means the individual on whose behalf the preneed contract is purchased. (3) “Board” means the State Board of Morticians and Funeral Directors. (4) “Buyer” means an individual who agrees to buy certain mortuary science services and merchandise in a preneed contractual arrangement. (5) “Casket vault” means a combination casket and outer burial enclosure. (6) “Contract” means preneed contract. (7) “Irrevocable trust” means an arrangement, which cannot be revoked after its creation, by which property is transferred with the intention that it be administered by a trustee for another's benefit. (8) “Licensee” means an individual who has been issued either a mortician, funeral director, or surviving spouse license by the Board. (9) “Preneed addendum form” means the form provided by the Board to show the allocation of preneed funds. (10) “Preneed contract” means an agreement entered into by a licensed mortician, a licensed funeral director, or holder of a surviving spouse license with a buyer in advance of the death of that individual or beneficiary. (11) “Seller” means a licensed mortician, licensed funeral director, or a holder of a surviving spouse license who agrees to sell certain mortuary science services or merchandise in a preneed contractual arrangement between a buyer and a funeral establishment. (12) “Trustee” means the seller of preneed mortuary services or merchandise selected under the terms of an irrevocable trust arrangement established on behalf of the beneficiary for the purpose of eligibility for Social Security or other governmental benefits. (13) “Unable to perform” means that the seller has died or become disabled, or that the funeral service business has discontinued. #### Regulation .03 Execution of Preneed Contract. *COMAR 10.29.06.03* A. Only a licensed mortician, licensed funeral director, or holder of a surviving spouse license may make pre-arrangements and execute preneed contracts with buyers. B. The seller shall present to the buyer a preneed contract which contains all of the information set forth in Health Occupations Article, §7-404, Annotated Code of Maryland. C. The seller and buyer of a preneed contract shall execute the contract in duplicate, with a copy of the original contract given to the buyer at the time that the contract is signed. D. The seller shall state in the preneed contract: (1) The time required for fulfilling the terms and conditions of the contract; (2) The cancellation terms; and (3) The conditions of refunds. E. A preneed contract may be funded by a life insurance policy or an annuity contract. F. A seller who funds preneed contracts using a life insurance policy or an annuity shall have an insurance license. G. A seller who funds preneed contracts using a life insurance policy or annuity shall: (1) Give the buyer a copy of the completed contract form signed and executed by the licensee, buyer, and insurance agent at the conclusion of preneed arrangements; (2) Ensure that the insurance company listed on the application for insurance is the recipient of the payment when the buyer is executing payment; (3) Send a copy of the certificate of insurance to the buyer immediately upon receipt of the approved insurance policy; and (4) Present a copy of a filed death certificate policy claim form and any other information required by the insurance company for payment of services provided under the preneed insurance contract. H. Funds may not be transferred from a money-trust to an insurance-funded vehicle without the approval and signature on the insurance application of the buyer or legal representative of the buyer. #### Regulation .04 Disposition of Preneed Contract Fund. *COMAR 10.29.06.04* A. Within 10 days of receiving payment under a preneed contract, the seller shall deposit into an interest-bearing escrow or trust account that is insured by the Federal Deposit Insurance Corporation (FDIC): (1) An amount from the payment that is equal to at least 80 percent of the selling price of a casket or casket vault under the preneed contract; and (2) 100 percent of the payment that is for all other goods and services under the preneed contract. B. The seller need not have a separate interest-bearing escrow or trust account for each preneed contract executed. C. The seller may place in the escrow account with the other funds up to 100 percent of the price of the casket or casket vault. D. Interest on Preneed Contract Fund. (1) The interest or dividends earned by the interest-bearing escrow or trust account belongs to the buyer of the contract. (2) The seller shall send to the buyer a tax form stating the amount of the interest accumulated in the account each year that the contract is in effect until the time of death of the beneficiary. (3) It is the responsibility of the buyer to pay the taxes due on that interest. (4) Money remaining in the interest-bearing escrow or trust account after the performance of the contract belongs to the seller. E. The seller may not withdraw from the account the money received from the buyer unless the services and merchandise have been provided as agreed to in the contract or unless the buyer terminates the contract. F. The seller may withdraw money from the account if one of the following conditions are met: (1) The buyer or legal representative of the buyer forwards a notarized statement and withdrawal request stating that the seller may: (a) Cancel the prepaid contract if revocable; or (b) Transfer the monies to a named substitute trustee if the prepaid contract is irrevocable; or (2) The funeral home presents a copy of a filed or certified death certificate to the banking institution holding the account funds for payment of services provided under a preneed contract. #### Regulation .05 Obligations of Seller. *COMAR 10.29.06.05* A. A seller shall provide the buyer with: (1) A general price list of all goods and services for the buyer to keep; (2) A statement of goods and services that are reasonably expected to be required at the time of need, but are not included in the preneed contract; (3) Information concerning cancellation and refund rights under Health Occupations Article, §7-405(d), Annotated Code of Maryland; (4) A receipt for all monies received and a copy of the completed forms signed and executed by the seller and the buyer; and (5) A copy of the deposit slip showing the amount of preneed funds deposited into an interest-bearing escrow or trust account with an FDIC insured account under Regulation .04A of this chapter. B. The seller shall perform the contract according to the contract's terms and at the agreed upon price. C. The seller shall substitute comparable merchandise when the specified merchandise is unavailable. D. The seller is not responsible for those events which are beyond the seller's control, such as changes in cemetery requirements. E. Nothing in this regulation shall prohibit a funeral home from its rights to transfer escrow or trust accounts from one institution to another FDIC insured banking institution. The funeral home shall provide the new account information to the buyer along with a copy of the deposit slip within 30 days after transferring preneed funds. F. The funeral establishment and the establishment's supervising mortician shall be responsible for providing the services contracted. In the case of a funeral establishment owned by a corporation licensed under Health Occupations Article, §7-309, Annotated Code of Maryland, the supervising mortician and the corporation shall be responsible for the services contracted. #### Regulation .06 Termination of Preneed Contract. *COMAR 10.29.06.06* A. Except as otherwise provided in this regulation, a preneed contract may not be terminated by the seller. B. Except as otherwise provided in this section, a seller may not withdraw from the preneed interest-bearing escrow or trust account the money received from a buyer unless the services and merchandise agreed to in the contract have been provided. C. At the time a preneed contract is terminated, the seller shall refund to the buyer the payments and interest held for the buyer, if any one of the following conditions occur: (1) The buyer or the legal representative or representatives of the buyer demands in writing a refund of the payments made except as set forth in Regulation .09 of this chapter; (2) The business of the seller is discontinued; (3) The seller is unable to perform under the terms and conditions of the preneed contract for reasons other than an increase in the cost of goods and services; or (4) The buyer fails to pay the entire contract price before the death of the beneficiary. #### Regulation .07 Premature Death of Beneficiary or Buyer. *COMAR 10.29.06.07* If the death of the buyer or beneficiary occurs before the terms and conditions of the preneed contract are met, the buyer or legal representative of the beneficiary shall be given the option of withdrawing all funds paid and interest accrued or renegotiating a contract with mutually agreed upon financial adjustments. #### Regulation .08 Sale or Change in the Ownership of a Funeral Corporation or Establishment. *COMAR 10.29.06.08* A. A funeral corporation or establishment which is in the process of being sold shall file with the Board a list of preneed contracts and document that the money resulting from the preneed contracts has been set aside in an interest-bearing, federally insured escrow or trust account. B. The seller of the funeral corporation or establishment shall document that arrangements have been made with the buyer and with another licensee to honor the preneed contracts. C. The seller shall notify the buyers of the preneed contract that the business is being sold and give the buyers an opportunity to either continue the same contractual arrangements with the new owner or to demand a refund of the money paid into the interest-bearing escrow or trust account. D. On the death or disability of the seller or if the seller loses or is unable to use that individual's license, the partners or surviving spouse shall notify the Board and document that the preneed contract money has been set aside and remains inviolate, and that arrangements have been made to honor the preneed contracts. E. On the death or disability of the seller or if the seller loses or is unable to use that individual's license, the buyer of the preneed contract shall be contacted and given an opportunity to either continue the arrangement with the remaining partners or surviving spouse or to demand a refund of the money paid into the interest-bearing escrow or trust account. F. If a licensee files for bankruptcy and that bankruptcy involves assets which include preneed contracts and bank accounts, the bankrupt, or the trustee appointed by the court to handle the bankruptcy, shall: (1) Notify the Board of that bankruptcy filing; (2) Document to the Board the number of preneed accounts that exist; (3) Identify the bank accounts for those preneed documents; and (4) Make assurances to the Board that the preneed accounts will be honored. G. If a licensee files for bankruptcy, the licensee shall notify the buyer of a preneed contract of the filing and give the buyer an opportunity to terminate the contract and obtain a full refund of the money paid under the preneed contract or to make arrangements to continue the agreement with the bankrupt seller or another seller. #### Regulation .09 Irrevocable Trusts. *COMAR 10.29.06.09* A. A buyer may establish an irrevocable trust with respect to all or any portion of the payment made under the contract in an interest-bearing, federally insured escrow or trust account held by the seller, but only for the purpose of entitling the buyer to be eligible for current Social Security benefits or for benefits under any other plan that restricts eligibility to those with limited assets. B. The seller shall present to the buyer a document establishing the irrevocable trust which provides: (1) The appointment of a trustee to sign all necessary papers to effectuate the contract upon the death of the buyer; (2) That the disposition of income earned by the trust inures to the benefit of the buyer; (3) The transfer of the trust funds, if required; and (4) The disposition of the trust funds if: (a) The business of the seller is discontinued, (b) The seller is unable to perform under the terms and conditions of the preneed contract, or (c) The buyer fails to pay the entire contract price before the death of the beneficiary. C. The buyer or legal representative of the buyer shall retain the right to appoint, as trustee of the irrevocable trust, a substitute trustee. D. If the buyer who sets up an irrevocable trust terminates the preneed contract with the seller, the buyer and seller shall take the following actions: (1) The seller shall maintain the funds in trust for the beneficiary until a substitute seller is selected; (2) The buyer shall enter into a new preneed contract with the substitute seller; and (3) The seller shall transfer the trust funds to the substitute seller for placement in a separate interest-bearing escrow account or trust account. E. Notwithstanding the provisions set forth in these regulations, when a buyer terminates the preneed contract, the funds contained in the irrevocable trust may not be returned to the buyer but the seller shall maintain the funds in trust for the beneficiary. F. Funds maintained in an irrevocable trust are not counted as assets with respect to the buyer's Social Security benefits, Medical Assistance eligibility, or any other plan which restricts eligibility to those with limited assets. G. The seller shall provide in the document establishing a trust the following notice, conspicuously displayed in 10-point boldface type: #### Regulation .10 Prohibitions. *COMAR 10.29.06.10* A. The following individuals may not enter into a preneed contract with a buyer: (1) The owner or director of a corporation license issued by the Board who is not also a licensed mortician, funeral director, or holder of a surviving spouse license; (2) A holder of an apprentice license; (3) A holder of a courtesy card license; or (4) An individual who is not licensed by the Board as a mortician, funeral director, or surviving spouse license holder. B. The following individuals may not advertise that they provide preneed contracts: (1) The owner or director of a corporation license issued by the Board who is not also a licensed mortician, funeral director, or holder of a surviving spouse license; (2) A holder of an apprentice license; (3) A holder of a courtesy card license; or (4) An individual who is not licensed by the Board as a mortician, funeral director, or surviving spouse license holder. ### Chapter 07 — Surviving Spouse **Authority:** Health Occupations Article, §7-308, Annotated Code of Maryland **Administrative History:** Effective date: June 20, 1994 (21:12 Md. R. 1060) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .06 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) #### Regulation .01 Scope. *COMAR 10.29.07.01* This chapter establishes standards for the issuance of a surviving spouse license by the State Board of Morticians and Funeral Directors. #### Regulation .02 Definitions. *COMAR 10.29.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Morticians and Funeral Directors. (2) “Funeral director” means an individual who is licensed by the Board to practice funeral direction. (3) “Mortician” means an individual who practices mortuary science. (4) “Mortuary science” means: (a) To operate a funeral establishment; (b) For compensation, to prepare a dead human body for disposition including disinfecting or preserving a dead human body or any of the body's parts by arterial or cavity injection; or (c) For compensation, to arrange for or make final disposition of a dead human body. (5) “Mortuary science business” means the activities and entity related to providing mortuary science services. (6) “Surviving spouse” means the husband or wife who is predeceased by a licensed mortician or funeral director. #### Regulation .03 Issuance of a Surviving Spouse License. *COMAR 10.29.07.03* A. Upon the death of a licensed mortician or funeral director, the surviving spouse shall: (1) Submit to the Board within 30 days of the death of the deceased spouse: (a) An application on a form required by the Board; (b) Documentation of the spouse's death; (c) Evidence that the licensed mortician or funeral director either wholly or partly owned the mortuary science business for which an establishment license was issued; (d) Information as to the role that the deceased licensed mortician had in the operation of that business; and (e) Any other information requested by the Board to verify either the ownership or operational details of the mortuary science business with which the deceased mortician or funeral director had been associated; and (2) Pay a fee pursuant to COMAR 10.29.04. B. The Board may not issue a surviving spouse license to a licensed mortician or funeral director. #### Regulation .04 Authority of Surviving Spouse License. *COMAR 10.29.07.04* The surviving spouse license shall authorize the licensee to: A. Continue the operation of the mortuary science business of the deceased licensed mortician as it had been operated at the time of the licensed mortician's death; and B. Assist with the planning and conducting of funeral services for that mortuary science business. #### Regulation .05 Duration of Surviving Spouse License. *COMAR 10.29.07.05* Subject to the renewal provisions of Regulation .09 of this chapter, a surviving spouse license shall remain effective if the license is used in accordance with Regulation .04 of this chapter. #### Regulation .06 Conditions of Issuance of a Surviving Spouse License. *COMAR 10.29.07.06* The Board may issue a surviving spouse license if the Board receives: A. Documentation that the business is to be operated under the direct supervision of a licensed mortician or funeral director; B. The name, address, and license number of the mortician or funeral director that will be operating the business; C. A written statement from a licensed mortician on a form required by the Board verifying that, if embalming is provided, the licensed mortician will provide direct supervision and perform the embalming or other means of final disposition of dead human bodies on behalf of the mortuary science business requesting the license; and D. Documentation that the business continues to be operated in the same manner or mode as it had been operated at the death of the licensed mortician or funeral director. #### Regulation .07 Limitations of Surviving Spouse License. *COMAR 10.29.07.07* A. A surviving spouse's practice is limited to the conduct of the deceased licensed mortician or funeral director's mortuary business as the mortuary business had been operated during the spouse's lifetime. B. Nothing in these regulations precludes the expansion or relocation of the business by a surviving spouse. #### Regulation .08 Prohibitions. *COMAR 10.29.07.08* A. The surviving spouse is prohibited from using the surviving spouse license to conduct business in any manner contrary to the provisions set forth in this chapter. B. The surviving spouse license may not be transferred to another person or to another person's mortuary science business or funeral establishment. #### Regulation .09 Leasing Space. *COMAR 10.29.07.09* A. The surviving spouse licensee may not be precluded from leasing space in another funeral establishment should the building no longer exist in which the mortuary science business of the deceased licensed mortician or funeral director was conducted. B. If space in a funeral establishment is leased, all transactions, stationery, funeral programs, bank or savings and loan records, advertisements, and other documents shall explicitly serve notice to the public that the mortuary science business operated by the surviving spouse is different from the establishment in which the funerals are conducted. C. If space in a funeral establishment is leased, the name of the business of the deceased mortician or funeral director shall be used in all advertisements, including obituary notice, with the name and address of the funeral establishment from which the space is leased. #### Regulation .10 Renewal. *COMAR 10.29.07.10* The license of a surviving spouse may be renewed every 2 years if the surviving spouse: A. Submits information on the form required by the Board; B. Pays the renewal fee required by the Board pursuant to COMAR 10.29.04; and C. Complies with the requirements under Health Occupations Article, Title 7, Annotated Code of Maryland. ### Chapter 08 — Courtesy Card **Authority:** Health Occupations Article, §§7-101(f) and 7-311, Annotated Code of Maryland **Administrative History:** Effective date: December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) #### Regulation .01 Scope. *COMAR 10.29.08.01* These regulations govern courtesy cards for those licensed to practice mortuary science in other states or countries who wish to transport bodies from Maryland to their states or countries of licensure or from their states or countries of licensure to Maryland. #### Regulation .02 Definitions. *COMAR 10.29.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Morticians and Funeral Directors. (2) “Committal service” means a ritual conducted at the graveside or crematory following a funeral held at a location other than a cemetery or crematory. (3) “Courtesy card” means a license issued by the Board to licensed practitioners of mortuary science in other states or countries which allows these practitioners to: (a) Remove a dead human body from this State and return the body to another state or country; (b) Return a dead human body from another state or country to this State for final disposition; (c) Fill out the family history portion of the death certificate; (d) Sign the death certificate in the holder's capacity as a licensed practitioner of mortuary science without the assistance of or being under the supervision of a Maryland licensed mortician or funeral director; and (e) Participate in committal services in Maryland without the assistance of a Maryland mortician or funeral director. (4) “Graveside funeral service” means a program or ritual conducted at the cemetery or crematory on behalf of a dead human body instead of one conducted at a funeral home or place of worship. #### Regulation .03 Requirements for Courtesy Card. *COMAR 10.29.08.03* A. An individual already licensed in another state or country to practice mortuary science may apply to the Board for a courtesy card. B. An individual licensed to practice mortuary science from another state or country, and who is seeking a courtesy card issued by the Board, shall fulfill the following requirements: (1) Complete an application on a form provided by the Board; (2) Have the state or country where the individual is licensed certify, by affixing the seal of that state or country on the completed application, that the applicant is a licensee in good standing in that state or country; and (3) Submit the completed, certified application form along with the fee specified in COMAR 10.29.04. #### Regulation .04 Authority of Courtesy Card. *COMAR 10.29.08.04* Upon issuance of a courtesy card by the Board, the courtesy cardholder is authorized to: A. Complete the family history portion of the death certificate and file it with the local health department or Maryland Department of Health; B. Complete any other forms, including the burial transit permit, incident to the disposition of a dead human body; C. Transport an embalmed or unembalmed body from the state or country of licensure to Maryland for interment or cremation without the assistance of or under the direction of a Maryland mortician or funeral director; D. Transport an embalmed or unembalmed body from Maryland to the state or country of licensure for interment or cremation without the assistance of or under the direction of a Maryland mortician or funeral director; and E. Conduct a committal service without the assistance of or under the direction of a Maryland mortician or funeral director. #### Regulation .05 Fee for Courtesy Card. *COMAR 10.29.08.05* The fee for a courtesy card, as specified in COMAR 10.29.04, is nonrefundable and shall be prorated according to a schedule set by the Board. #### Regulation .06 Requirements for Renewal of Courtesy Card. *COMAR 10.29.08.06* To renew a current courtesy card, the courtesy cardholder shall: A. Complete a renewal application form provided by the Board; B. Have the state or country where the individual is licensed certify, by affixing the seal of that state or country on the completed application, that the applicant is a licensee in good standing in that state or country; and C. Pay the renewal fee as specified in COMAR 10.29.04. #### Regulation .07 Prohibitions. *COMAR 10.29.08.07* The holder of a courtesy card may not: A. Transfer the card to another individual; B. Own a funeral business in Maryland unless the courtesy cardholder is also an owner of or director in a corporation whose license is issued by the Board; or C. Except for the requirements listed in Regulation .04 of this chapter, perform any of the acts related to the practice of mortuary science in Maryland including, but not limited to: (1) Arranging for funerals; (2) Conducting funerals in Maryland, including graveside services; (3) Advertising as a practitioner of mortuary science services in Maryland; (4) Signing contracts for funeral services in Maryland; or (5) Preparing deceased human remains in Maryland for disposal. ### Chapter 09 — Requirements for Apprenticeship **Authority:** Health Occupations Article, §§7-101, 7-205, 7-305, and 7-306, Annotated Code of Maryland **Administrative History:** Effective date: May 20, 1996 (23:10 Md. R. 732) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02 amended effective January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02B amended effective September 7, 2009 (36:18 Md. R. 1380); August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .03 amended effective January 7, 2002 (28:26 Md. R. 2273); August 28, 2017 (44:17 Md. R. 835); May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .03A, C amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03B amended effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .04 amended effective January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .04 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .04 amended effective August 28, 2017 (44:17 Md. R. 835); May 18, 2020 (47:10 Md. R. 518) **Administrative History:** Regulation .04A amended effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .05 amended effective January 7, 2002 (28:26 Md. R. 2273); August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .05A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .05D adopted as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); adopted permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .06 amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .06C adopted effective September 7, 2009 (36:18 Md. R. 1380) **Administrative History:** Regulation .07 amended effective January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .07 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .09 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .09 amended effective December 29, 2008 (35:26 Md. R. 2250) **Administrative History:** Regulation .10 amended effective January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .11 amended effective January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .11 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .11A amended effective April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .11E amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .12 amended effective January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .12D, G amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .14A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .14B, C amended effective August 28, 2017 (44:17 Md. R. 835) #### Regulation .01 Scope. *COMAR 10.29.09.01* This chapter sets forth specific criteria which an apprentice shall meet before becoming a licensed mortician or funeral director in Maryland. #### Regulation .02 Definitions. *COMAR 10.29.09.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Apprentice” means an individual licensed by the Board who assists and is employed at the same licensed Maryland establishment as the sponsor of the apprentice, and is under the direct supervision of a licensed Maryland mortician or funeral director. (2) “Apprentice sponsor” means a mortician or funeral director who: (a) Has been in good standing with the Board for the previous 5 years; (b) Has been practicing mortuary science as a licensed mortician or funeral director in Maryland at least 5 years immediately before accepting the apprentice; (c) Manages, owns, or is employed by a licensed funeral establishment in Maryland in which the licensed apprentice is employed; (d) Is responsible for the direct supervision of 1,000 hours of work with the apprentice; and (e) Assumes responsibility on their individual license for the delegate or apprentice’s conduct, whether it is consistent or fails to be consistent with the professional standards and provisions set forth in Health Occupations Article, Title 7, Annotated Code of Maryland. (3) “Board” means the State Board of Morticians and Funeral Directors. (4) “Committal services” means a ritual conducted at the graveside or crematory following a funeral held at a location other than a cemetery or crematory. (5) “Delegate” means a licensed mortician or a licensed funeral director employed by the same licensed funeral establishment as the apprentice sponsor and to whom the apprentice sponsor delegates direct supervision. (6) “Direct supervision” has the same meaning as in Health Occupations Article, §7-306(e)(3), Annotated Code of Maryland. (7) “Graveside services” means any program or rituals conducted at the cemetery or crematory on behalf of a decedent instead of one conducted at a funeral home or place of worship. (8) “Licensed apprentice” means an apprentice who is licensed by the Board to assist the apprentice sponsor or a licensee delegated by the sponsor to provide direct supervision. (9) “Licensed funeral director” means a funeral director who is licensed by the Board to practice all aspects of mortuary science except embalming. (10) “Licensed mortician” means a mortician who is licensed by the Board to practice mortuary science. #### Regulation .03 Requirements of Apprenticeship. *COMAR 10.29.09.03* A. To meet the apprentice requirements set forth in Health Occupations Article, §7-306, Annotated Code of Maryland, an applicant for a mortician’s or funeral director’s license shall be: (1) Employed in the same Maryland establishment as the applicant’s sponsor or the sponsor’s delegate; and (2) Serve under the direct supervision of the applicant’s sponsor or the sponsor’s delegate. B. Applicants shall obtain practical experience in funeral service arrangements, including: (1) 20 funeral directions, including at least four of each of the following: (a) A pre-need arrangement; (b) An at-need arrangement for burial; (c) A cremation arrangement; and (d) A cemetery transfer with a service; and (2) 1,000 hours worked under the direct supervision of the apprentice sponsor or the sponsor’s delegate. C. An applicant for a mortician’s license shall obtain practical experience in funeral service arrangements consisting of: (1) Participation in the activities outlined in §B of this regulation; and (2) 20 embalmings under the direct supervision of the sponsor or the sponsor’s delegate. #### Regulation .04 Documentation. *COMAR 10.29.09.04* A. An apprentice shall submit documentation to the Board of completion of the following requirements to be considered for a mortician’s license: (1) Certified transcripts of completion of educational requirements as set forth in Health Occupations Article, §7-306, Annotated Code of Maryland; (2) On the mortician application form provided by the Board, evidence of participation in: (a) 20 embalming assists with corresponding copies of the filed death certificates for the embalmed human remains; and (b) 20 funeral direction assists, as specified in Regulation .03B(1) of this chapter, with a corresponding published notice of the service for each of the at least 20 decedents and a copy of the filed death certificate; (3) A notarized statement signed by the apprentice and the apprentice sponsor verifying the completion of 1,000 hours worked under the direct supervision of the apprentice sponsor; (4) Embalming reports signed by the apprentice and apprentice sponsor to document the apprentice’s participation in 20 embalmings; and (5) Documentation on a form provided by the Board and signed by the apprentice and apprentice sponsor or the sponsor’s delegate of participation in at least four of each of the following: (a) A pre-need arrangement; (b) An at-need arrangement for burial; (c) A cremation arrangement; and (d) A cemetery transfer with a service. B. An apprentice shall submit documentation to the Board of completion of the following requirements to be considered for a funeral director’s license: (1) Certified transcripts of completion of educational requirements as set forth in Health Occupations Article, §7-306, Annotated Code of Maryland; (2) On the funeral director application form provided by the Board, evidence of participation in 20 funeral assists; and (3) A notarized statement signed by the apprentice and the apprentice sponsor verifying the completion of: (a) 20 funeral directions, including at least four of each of the following: (i) A pre-need arrangement; (ii) An at-need arrangement for burial; (iii) A cremation arrangement; and (iv) A cemetery transfer with a service; and (b) 1,000 hours worked under the direct supervision of the apprentice sponsor or sponsor’s delegate. #### Regulation .05 Embalming Requirements for Mortuary Science Apprenticeship. *COMAR 10.29.09.05* A. If the apprentice sponsor has more than one apprentice, unless otherwise approved by the Board, only one apprentice may receive credit on the same human remains if more than one apprentice assisted the apprentice sponsor. B. Applicants for an apprenticeship who are studying to be funeral directors are exempt from the practical aspects of embalming. #### Regulation .06 Commencement of Apprenticeship. *COMAR 10.29.09.06* A. The apprentice and the apprentice sponsor or sponsors shall appear before the Board and receive the Board’s approval of the apprenticeship before the apprenticeship commences. B. The apprentice and the apprentice sponsor shall sign an agreement with the Board to adhere to the conditions and requirements of apprenticeship before the apprenticeship commences. C. The apprentice may have no more than two sponsors who shall attest to the Board what each sponsor is responsible for teaching the apprentice. D. The apprentice sponsor shall assume responsibility on their individual license for the delegate or apprentice’s conduct, whether it is consistent or fails to be consistent with the professional standards and provisions set forth in Health Occupations Article, Title 7, Annotated Code of Maryland. #### Regulation .07 Termination of Apprenticeship. *COMAR 10.29.09.07* A. The sponsor and the apprentice shall submit a notarized statement indicating the: (1) Name of each decedent for whom a funeral arrangement was conducted in which the apprentice assisted; (2) Date of each assisted funeral arrangement; (3) Name of each decedent for whom an embalming was conducted in which the apprentice who is studying to be a mortician assisted; and (4) Date of each assisted embalming. B. In order for an apprentice to receive credit for the required funeral assists and embalmings, the apprentice shall submit a notarized statement to the Board which reflects the number of assisted funeral arrangements and assisted embalmings completed within 30 days of termination of the apprenticeship to the Board. C. In order for the apprentice studying to be a funeral director to receive credit for the required funeral assists, the apprentice shall submit a notarized statement to the Board which reflects the number of assisted funeral arrangements completed within 30 days of termination of the apprenticeship. D. Documentation by the apprentice and apprentice sponsor shall be independently submitted to the Board within 30 days of the date of termination of the apprentice sponsor and apprentice relationship as noted in Health Occupations Article, §7-306(c)(4), Annotated Code of Maryland. E. The Board shall maintain the documentation of apprenticeship requirements for 3 years after the date of termination as noted in §B of this regulation and apply the apprenticeship requirements to the individual seeking a mortician's license. F. After 3 years from the date of submission of the documentation by the apprentice to the Board, the Board may not apply credit for the apprenticeship unless an individual petitions the Board to do so citing unusual circumstances which the Board may decide on a case-by-case basis. #### Regulation .08 Laws and Regulations. *COMAR 10.29.09.08* All licensed apprentices shall become competent in the knowledge of Maryland and federal laws and regulations as they apply to the funeral profession. #### Regulation .09 Waiver of Apprenticeship Requirements. *COMAR 10.29.09.09* A. A mortician or funeral director who is licensed by another state and who is in good standing with the state of licensure may apply in writing to the Board for a waiver of the examination and apprenticeship requirements under Health Occupations Article, §7-303, Annotated Code of Maryland. B. The Board may issue a mortician or funeral director license to an applicant who is licensed to practice mortuary science or funeral direction in any other state if the applicant: (1) Is a licensed mortician, funeral director, or other equivalent health care occupation in good standing and has practiced continuously in the state of licensure as a mortician for at least 5 years preceding the waiver request; (2) Serves an apprenticeship consisting of at least 1,000 hours in Maryland and documents that apprenticeship to the Board, or has served an apprenticeship of at least 1,000 hours in the applicant's state of initial licensure; (3) Passes the Maryland law portion of the written examination administered by the Board; and (4) Pays the fees required as specified in COMAR 10.29.04. C. The Board may grant a waiver only if the state in which the applicant is licensed: (1) Grants a similar waiver to Maryland licensees; and (2) Has standards for a mortician or funeral director license that are not lower than those of this State. #### Regulation .10 Change in the Apprenticeship. *COMAR 10.29.09.10* A. If the apprentice sponsor and apprentice relationship changes, both the apprentice and the apprentice sponsor shall notify the Board of the termination of the apprenticeship in writing and document to the Board in affidavit form the number of hours worked and the funeral arrangements and embalming assists participated in by the apprentice as of the date of termination as noted in Regulation .07 of this chapter. B. If the apprentice obtains a new sponsor, both the apprentice and the new sponsor shall appear before the Board to obtain approval of the apprenticeship before the apprenticeship commences. #### Regulation .11 General Requirements. *COMAR 10.29.09.11* A. Education. (1) The applicant shall submit to the Board a certified copy of a high school diploma, G.E.D., or a certified transcript of any post high school degree received. (2) Before an applicant appears before the Board for approval of an apprentice license, the applicant shall be enrolled in or have graduated from a mortuary science program at a school accredited by the American Board of Funeral Service or approved by the Board, with a 2.0 or higher grade point average that is verified with a certified copy of the college transcript, if the applicant has a grade point average. (3) A licensed apprentice who was enrolled in a mortuary science program at the time the license was granted shall remain enrolled in the program for the duration of the apprenticeship unless the licensed apprentice graduates. (4) The applicant shall appear before the Board with a sponsor who: (a) Holds a current valid mortician or funeral director license in Maryland; and (b) Is employed by the same funeral home that employs the apprentice. B. Except as otherwise provided for in Regulation .12 of this chapter, the mortician's apprentice shall obtain an Associate of Arts (AA) Degree in Mortuary Science or its equivalent from a school recognized by the Board within 3 years of commencing the apprenticeship. C. Except as otherwise provided for in Regulation .12 of this chapter, the funeral director's apprentice shall obtain an Associate of Arts (AA) degree in funeral service or its equivalent from a school recognized by the Board within 3 years of commencing the apprenticeship. D. The 3 years of apprenticeship shall consist of: (1) The initial year of apprenticeship licensure; and (2) Two consecutive apprenticeship licensure renewals. E. The applicant shall: (1) Apply for apprenticeship on the form required by the Board; and (2) Pay the fee as specified in COMAR 10.29.04. #### Regulation .12 Renewals and Extensions. *COMAR 10.29.09.12* A. An apprentice may renew the apprenticeship license by submitting a renewal application on the form required by the Board. B. An apprentice may renew the apprenticeship license annually for not more than 2 consecutive years. C. If after 4 years, consisting of the initial license as an apprentice and two consecutive renewals, the apprentice has not completed the requirements of the apprenticeship, the apprentice may submit to the Board a written request for an extension which the Board may grant upon good cause shown. D. If the apprentice fails to obtain the AA degree in mortuary science or an AA degree in funeral service from a school recognized by the Board or fails to meet any other apprenticeship requirements specified in this chapter within 3 years of the commencement of the apprenticeship, the apprentice may apply for an extension of the apprenticeship which the Board may grant for good cause shown. E. The Board may not grant more than two extensions to an apprentice. F. An apprentice requesting a renewal or extension of the apprenticeship shall pay the fee specified in COMAR 10.29.04 to the Board. G. An apprentice requesting an extension shall submit a copy of the transcript from the mortuary science course, funeral service course, or school of higher education to verify pursuit of the educational requirement. H. An apprentice who has allowed the apprentice's apprenticeship license to lapse for more than 6 months from the expiration date on the license and who desires to resume the apprenticeship shall appear before the Board with the sponsor and provide documentation of the: (1) Reasons for allowing the apprenticeship license to lapse; and (2) Requirements of apprenticeship which have been met to date. I. The Board may approve a new period of apprenticeship crediting the number of hours worked and the funeral or embalming assists earned under the prior apprenticeship to the new apprenticeship. #### Regulation .13 Examinations. *COMAR 10.29.09.13* An apprentice may take the examination administered by the Board at any time during the apprenticeship. #### Regulation .14 Prohibitions. *COMAR 10.29.09.14* A. An apprentice may not assist a mortician or funeral director unless both individuals have current licenses. B. An apprentice may participate in making funeral arrangements with the sponsor or the sponsor’s delegate, but may not make funeral arrangements, including pre-need funeral arrangements, embalm human remains, or conduct funerals, including graveside or committal services, unless the apprentice is under the direct supervision of the sponsor or the sponsor’s delegate. C. An apprentice may not sign a funeral establishment contract. D. An apprentice may not advertise as a provider of funeral services in Maryland. E. An apprentice may not sign at-need contracts. F. A sponsor may not sponsor more than two apprentices at the same time. ### Chapter 10 — Monetary Penalties **Authority:** Health Occupations Article, §§1-212 and 7-317, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1996 (22:26 Md. R. 2029) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03C amended effective March 5, 2001 (28:4 Md. R. 418) #### Regulation .01 Scope. *COMAR 10.29.10.01* These regulations establish standards for the imposition of penalties not exceeding $5,000 against any mortuary science practitioner licensee in the State if, after a hearing, the Board finds that there are grounds under Health Occupations Article, §7-316, Annotated Code of Maryland, to suspend or revoke a license. #### Regulation .02 Definitions. *COMAR 10.29.10.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Morticians and Funeral Directors. (2) “Licensee” means, unless the context requires otherwise, a holder of a license issued by the Board to practice mortuary science in Maryland to the extent permitted under Health Occupations Article, Title 7, Annotated Code of Maryland. (3) “Penalty” means monetary fine. #### Regulation .03 Imposition of Penalties on Licensees. *COMAR 10.29.10.03* A. A penalty of not less than $100 or more than $2,500 may be imposed by the Board on a licensee found in violation of any of the following: (1) Advertising falsely; (2) Advertising in a misleading manner; (3) Employing, paying, or offering to pay an individual to obtain business, either in general or for a particular mortician, funeral director, surviving spouse, or funeral establishment. (4) Directly or indirectly paying or offering to pay to obtain mortuary science business; (5) Soliciting or accepting any payment or rebate for recommending any crematory, mausoleum, or cemetery; (6) Soliciting or accepting any share, certificate, or interest in a mortuary science business with a promise or offer to perform services to the buyer at a cost less than that offered to the general public. (7) Selling or offering to sell any share, certificate, or interest in a mortuary science business with a promise or offer to perform services to the buyer at a cost less than that offered to the general public. (8) Practicing mortuary science under a name other than the name: (a) That appears on the license of that person; or (b) Of a partnership in accordance with Health Occupations Article, §7-401, Annotated Code of Maryland; or (9) Violating any provision of Health Occupations Article, §7-316(a)(18), Annotated Code of Maryland. (10) Violating any regulation adopted by the Board. B. A penalty of not less than $200 or more than $3,500 may be imposed by the Board on a licensee found in violation of any of the following: (1) Soliciting mortuary science business, either personally or by an agent, from a dying individual or the relatives of a dead or dying individual, other than through general advertising; (2) Refusing to surrender custody of a dead human body on the demand of a person who is entitled to its custody; (3) Failing to give the written statement required by Health Occupations Article, §7-404, Annotated Code of Maryland, at the time funeral arrangements are made; (4) Violating any State, municipal, or county law, rule, or regulation on the handling, custody, care, transportation, or the disposal of dead human bodies, as required by Health Occupations Article, §7-316(a)(15), Annotated Code of Maryland; (5) Signing an application for a funeral establishment license if the signer knew or should have known that grounds existed for which the funeral establishment license later was denied, suspended, or revoked; (6) Is disciplined by a licensing or disciplinary authority of any other state or county or convicted or disciplined by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes; (7) Willfully failing to file or record a report as required under law; (8) Willfully impeding or obstructing the filing or recording of a report; (9) Inducing another to fail to file or record the report; (10) Providing professional services while: (a) Under the influence of alcohol; or (b) Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; or (11) Failing to allow an inspection under Health Occupations Article, §7-205(8), Annotated Code of Maryland. C. A penalty of not less than $500 or more than $5,000 may be imposed by the Board on a licensee found in violation of any of the following: (1) Fraudulently or deceptively obtaining or attempting to obtain a license for the applicant or licensee or for another; (2) Fraudulantly or deceptively using a license; (3) Committing fraud or misrepresentation in the practice of mortuary science; (4) Conviction of or plea of guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether any appeal or other proceeding is pending to have the conviction or plea set aside; (5) Aiding or abetting an unauthorized person in the practice of mortuary science; (6) Failing, after proper demand, to refund promptly any payments received under a preneed contract; (7) Willfully making or filing a false report or record in the practice of mortuary science; (8) Submitting a false statement to collect a fee; (9) Being professionally, physically, or mentally incompetent; (10) Committing an act of unprofessional conduct in the practice of mortuary science; (11) Refusing, withholding from, denying, or discriminating against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; (12) Except in an emergency life-threatening situation where it is not feasible or practicable, failing to comply with the Centers for Disease Control's guidelines on universal precautions; (13) Failing to comply with inspection requirements in the time specified by the Board; or (14) Sexual misconduct that includes, but is not limited to: (a) Sexual behavior with a consumer in the context of a professional service to the consumer, regardless of the setting in which the professional service is rendered; (b) Sexual behavior with a consumer of funeral services under the pretext of a benefit; (c) Solicitation of a sexual relationship, whether consensual or nonconsensual, with a consumer of funeral services; (d) Sexual advances requesting sexual favors; (e) Inappropriate or intentional touching of a sexual nature; (f) A verbal comment of a sexual nature; (g) Physical contact of a sexual nature with a consumer of funeral services; (h) Discussion of unnecessary sexual matters while providing funeral services; (i) The taking of photographs of consumers of funeral services for a sexual purpose; (j) Sexual harassment of staff or students; (k) An unnecessary sensual act or comment; or (l) Sexual contact with an incompetent or unconscious consumer of funeral services. #### Regulation .04 Factors to be Considered in the Assessment of a Penalty. *COMAR 10.29.10.04* In those cases in which the Board determines that the imposition of a penalty is appropriate, the Board shall take into consideration the following factors, without limitations, in determining the amount of penalty: A. The extent to which the licensee derived any financial benefit from unprofessional or improper conduct; B. The willfulness of the unprofessional or improper conduct; C. The extent of actual or potential public harm caused by the unprofessional or improper conduct; and D. The cost of investigating and prosecuting the case against the licensee. #### Regulation .05 Payment of a Penalty. *COMAR 10.29.10.05* A. A licensee shall pay to the Board a penalty imposed under these regulations as of the date the Board's order is issued, unless the Board's order specifies otherwise. B. Filing an appeal under State Government Article, §10-215, Annotated Code of Maryland, or Health Occupations Article, §7-320, Annotated Code of Maryland, does not automatically stay imposition of a penalty imposed by the Board pursuant to these regulations. C. If a licensee fails to pay, in whole or in part, a penalty imposed by the Board pursuant to these regulations, the Board may not restore, reinstate, or renew a license until the penalty has been paid in full. D. In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Fiscal Planning to institute and maintain proceedings to ensure prompt payment. E. The Board shall pay all monies collected pursuant to these regulations into the State's General Fund. ### Chapter 11 — Complaint Procedures **Authority:** Health Occupations Article, §7-205(a), Annotated Code of Maryland **Administrative History:** Effective date: July 15, 1996 (23:14 Md. R. 1009) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .01 amended effective July 4, 2016 (43:13 Md. R. 713) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02B amended effective July 4, 2016 (43:13 Md. R. 713) **Administrative History:** Regulation .03 amended effective July 4, 2016 (43:13 Md. R. 713) **Administrative History:** Regulation .04 amended effective July 4, 2016 (43:13 Md. R. 713) **Administrative History:** Regulation .05E amended effective July 4, 2016 (43:13 Md. R. 713) **Administrative History:** Regulation .06B amended effective July 4, 2016 (43:13 Md. R. 713) #### Regulation .01 Scope. *COMAR 10.29.11.01* This chapter applies to the handling of all complaints against licensees of the State Board of Morticians and Funeral Directors. #### Regulation .02 Definitions. *COMAR 10.29.11.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Act” means Health Occupations Article, Title 7, Annotated Code of Maryland. (2) “Board” means the Board of Morticians and Funeral Directors. (3) “Cease and desist letter” means a letter commanding an individual to stop engaging in certain prohibited activities under the Act. (4) “Committee” means the Complaint Committee of the Board, which includes at least one mortician member of the Board and at least one consumer member of the Board, and which is assisted by Board counsel provided by the Attorney General’s Office and Board administrative personnel. (5) “Complaint” means a report of a potential violation during the performance of mortuary services against an individual licensed by the Board. (6) “Complainant” means an individual who files a complaint with the Board. (7) “Confidential” means that neither the complaint nor resolution of it by the Board may be released to the public, including to the complainant, pursuant to General Provisions Article, §4–333, Annotated Code of Maryland. (8) “Consent order” means a written agreement reached by the licensee and the Board as a result of a prehearing conference which sets forth the terms and conditions regarding the licensee’s ability or inability to practice and is subject to release to the public, pursuant to General Provisions Article, §4–333, Annotated Code of Maryland. (9) “Disposition agreement” means a confidential agreement entered into between the Board and the licensee whereby the Board agrees to resolve the matter after the filing of charges in return for the licensee's agreeing to meet certain specified terms and conditions which remain a permanent part of the licensee's record and can be used in considering sanction should further disciplinary action be required. (10) “Educational letter” means a dismissal notice which specifically sets forth in an instructive manner the areas of the licensee's practice which require improvement and which, when applicable, includes a warning that any further complaints for the same or similar activities may result in disciplinary charges under the Act. (11) “Informal meeting” means a voluntary meeting of the Board and the licensee, either on the licensee's own initiative or on the Board's initiative, following notice to the licensee regarding the precise purpose of the meeting in the context of an ongoing investigation or inquiry. (12) “Jurisdiction” means within the Board's authority as set forth in the Act. (13) “Letter of admonishment” means a letter which sets forth that the: (a) Board has probable cause to charge the licensee with a violation of a specific provision of the Board's Act; (b) Licensee is admonished and ordered to cease and desist from all further activities in violation of its Act; and (c) Letter will become part of the licensee's permanent record with the Board but will be treated as part of the confidential record maintained by the Board on the licensee and can be considered in determining sanctions for any subsequent violation of the Act. (14) “Letter of dismissal” means a letter from the Board advising the licensee that: (a) The investigation into the allegations raised has been closed; (b) Violations were not found; and (c) The information obtained during the course of the investigation will be treated as a confidential record of the licensee maintained by the Board. (15) “Letter of surrender” means an agreement between the Board and licensee whereby the Board specifies the terms for the complete and unequivocal surrender of the licensee's license and right to practice mortuary science. (16) “Licensee” means an individual licensed by the Board of Morticians and Funeral Directors against whom a complaint has been filed. (17) “Mortuary services” means any service provided to a decedent or their family that requires any license issued by the Board. #### Regulation .03 Filing of Complaint. *COMAR 10.29.11.03* A. A complaint may come to the Board by any means from the public or a Board member. B. A complaint received by the Board shall be recorded on a complaint log. C. When the complaint to the Board against a licensee is filed, the complaint will be completed on a form devised by the Board and according to the instructions provided. D. In an emergency situation the Board may act upon a complaint received by telephone if that complaint is followed up in writing. E. The Board may also act upon a complaint signed by a Board member if the complaint is recorded on the log and the Board member refrains from further participation in the discussion or vote in the matter. #### Regulation .04 Disposition of Complaint by Complaint Committee. *COMAR 10.29.11.04* A. Upon receipt of a complaint, the administrative personnel shall present the complaint to the Complaint Committee of the Board. B. The Committee shall review the complaint and make a determination as to whether the complaint falls within the Board's jurisdiction. C. If the Committee determines that the complaint does not fall within the Board’s jurisdiction, the determination shall be reported to the Board at its next regularly scheduled Board meeting. If the Board concurs with the recommendation of the Committee, the Board shall vote to close the complaint with no Board action. D. If the Board determines that the complaint falls under the jurisdiction of another agency, the Board staff shall refer the complaint to the appropriate agency. E. If the Committee determines that the complaint would fall within the Board’s jurisdiction, the Board shall vote to open the complaint for investigation. F. The Committee shall review the licensee's response or report and make a recommendation to the Board for disposition of the case. The Committee may request that: (1) Supplemental information be obtained; (2) A supplemental investigation be conducted; or (3) Clarification of the responses or report be received. G. The complaint committee shall, by a majority of the members present at a regularly scheduled Committee meeting, make a recommendation to the Board based on the following actions: (1) That the Board take informal action by issuing one of the following: (a) Cease and desist letter; (b) Educational letter; (c) Informal meeting; (d) Letter of admonishment; or (e) Letter of dismissal; or (2) That the Board take formal action by voting to charge the licensee with a violation of the Act and subsequently making a referral of the case to the Attorney General's Office for prosecution. #### Regulation .05 Board Action on Complaints. *COMAR 10.29.11.05* A. The Board, upon receipt of the Committee's recommendations, shall take one of the following actions: (1) Accept the Committee's recommendations; (2) Accept the Committee's recommendation with modifications; or (3) Reject the Committee's recommendations with instructions. B. If the Board refers a case to the Attorney General's Office for prosecution, a liaison shall be assigned to assist the prosecutor with the preparation of the charges. C. Upon receipt of the charges prepared by the prosecutor, the Board shall vote to ratify the charge document. D. After a prehearing conference or a hearing on the charges, the Board may vote to: (1) Discuss the complaint or any sections of the charges; (2) Find no violation; (3) Find a violation and issue a disposition agreement; (4) Issue a cease and desist order; (5) Issue a reprimand; (6) Place a licensee on probation, with or without conditions; (7) Charge a monetary penalty; (8) Issue a suspension of the licensee; (9) Revoke a license; or (10) Combine any of the above. E. In addition, following the Board’s vote, the Board shall issue a written document regarding the action taken. All of these documents will be sent to the licensee. The Board shall notify the complainant of the resolution of the complaint, as permitted by General Provisions Article, §4–333, Annotated Code of Maryland. #### Regulation .06 Confidentiality. *COMAR 10.29.11.06* A. A disposition agreement remains confidential and may only be released to the public if the licensee is found guilty of a violation of a provision of the agreement or subsequent violation of the Act, after a hearing, pursuant to Health Occupations Article, §7-319, Annotated Code of Maryland. B. An educational letter and a letter of admonishment is treated as a confidential record maintained by the Board on the licensee. ### Chapter 12 — Advertising **Authority:** Health Occupations Article, §7-205(7), Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1996 (22:26 Md. R. 2029) **Administrative History:** Regulation .01 amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .03A amended effective April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .05 amended effective April 4, 2022 (49:7 Md. R. 466) #### Regulation .01 Scope. *COMAR 10.29.12.01* This chapter governs advertising by all persons licensed by the Board of Morticians and Funeral Directors in Maryland. #### Regulation .02 Definitions. *COMAR 10.29.12.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advertising” means calling to the attention of the public the services one has to offer. (2) “Board” means the Board of Morticians. (3) Licensee. (a) “Licensee” means a licensed mortician, funeral director, or a surviving spouse license holder who holds a current license to practice mortuary science in Maryland. (b) “Licensee” may mean a funeral establishment in some instances. #### Regulation .03 Advertising. *COMAR 10.29.12.03* A. A licensee may: (1) Advertise mortuary science services subject to the provisions of this regulation; (2) Use the initials LM or LFD after their name to indicate that the licensee is authorized to practice mortuary science or funeral direction as a: (a) Licensed mortician (LM); or (b) Licensed funeral director (LFD); and (3) Represent to the public that the licensee is a: (a) Licensed mortician (LM); or (b) Licensed funeral director (LFD). B. An advertisement may not contain statements: (1) Containing misrepresentation of facts; (2) Likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts; (3) Intended to or likely to create false or unjustified expectations of favorable results; (4) Relating to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to laypersons; (5) Conveying the impression that the licensee could influence improperly any public body, official, corporation, or person on behalf of the public; (6) Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent individual to misunderstand or be deceived; (7) Containing representations that the licensee is willing to provide services which are illegal under the laws or regulations of Maryland or the United States; or (8) That fail to state that the licensee is licensed to practice mortuary science in Maryland. C. A licensee shall be accountable under this regulation if the licensee uses an agent or partnership to implement actions prohibited by this regulation. D. A funeral establishment may advertise that it is able to provide preneed services as specified in Health Occupations Article, Title 7, Annotated Code of Maryland. #### Regulation .04 Solicitation. *COMAR 10.29.12.04* A. A licensee may not engage in solicitation, including, but not limited to, in-person, telephone, or direct mail solicitation which: (1) Amounts to fraud, undue influence, intimidation, or overreaching; or (2) Contains statements which would be improper under Regulation .03B of this chapter. B. A licensee shall be accountable under this regulation if the licensee uses an agent or partnership to implement actions prohibited by this regulation. #### Regulation .05 Prohibitions. *COMAR 10.29.12.05* A. A licensee is prohibited from: (1) Soliciting mortuary science business from a dying individual or the relatives of a dying individual other than through general advertising; (2) Employing, paying, or offering to pay a person to obtain business, either in general or for a particular mortician, funeral director, surviving spouse, or funeral establishment; and (3) Soliciting or accepting payment or rebate for recommending any crematory, mausoleum, or cemetery, suggesting that a dead human body be disposed of there. B. Unless licensed by the Board, an individual may not: (1) Use the initials LM or LFD after the name of the individual to indicate that the individual is authorized to practice mortuary science or funeral direction as a: (a) Licensed mortician (LM); or (b) Licensed funeral director (LFD); or (2) Represent to the public that the individual is a: (a) Licensed mortician (LM); or (b) Licensed funeral director (LFD). C. An apprentice licensee may not advertise the provision of mortuary science services in Maryland. D. A courtesy card holder may not advertise the provision of mortuary science services in Maryland. #### Regulation .06 Penalties for Violation. *COMAR 10.29.12.06* A violation of these regulations pertaining to the use of advertising may result in disciplinary action against the licensee under Health Occupations Article, §7-316, Annotated Code of Maryland. ### Chapter 13 — Rehabilitation Committee **Authority:** Health Occupations Article, §§7-205 and 7-408, Annotated Code of Maryland **Administrative History:** Effective date: January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .01A amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) **Administrative History:** Regulation .02B amended as an emergency provision effective November 5, 2007 (34:24 Md. R. 2154); amended permanently effective February 25, 2008 (35:4 Md. R. 514) #### Regulation .01 Scope. *COMAR 10.29.13.01* A. This chapter applies to the Rehabilitation Committee of the Board of Morticians and Funeral Directors. B. The President of the Board shall appoint the Rehabilitation Committee members. C. The Rehabilitation Committee is a panel which consists of a licensee member and a consumer member of the Board assisted by administrative staff and Board Counsel. D. The Rehabilitation Committee shall: (1) Determine where meetings are held and the frequency of the meetings; (2) Keep confidential minutes and maintain those minutes in a confidential file at the Board office; and (3) Review and approve the procedures established by the Rehabilitation Committee. #### Regulation .02 Definitions. *COMAR 10.29.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Morticians and Funeral Directors. (2) “Committee” means the Rehabilitation Committee of the Board. (3) “Formal agreement” means a written agreement between the Committee and the practitioner that lists: (a) The individual requirements for the practitioner in the program; and (b) The conditions that shall be met by the practitioner. (4) “Impaired practitioner” means a licensee who is not capable of practicing mortuary science competently and is in need of treatment and rehabilitation for alcoholism, drug abuse, chemical dependency, or other physical, emotional, or mental condition. (5) “Practitioner” means a licensed apprentice, funeral director, mortician, or surviving spouse. (6) “Program” means the treatment and rehabilitation plan established by the Committee and agreed upon by the practitioner. (7) “Treatment entity” means a licensed health care provider or licensed center for the evaluation, care, or rehabilitation, or all of these, of an impaired practitioner. #### Regulation .03 Functions. *COMAR 10.29.13.03* A. The Committee, without cost to the Board, shall provide appropriate rehabilitative assistance to impaired practitioners. B. The Committee shall: (1) Make an initial review of the nature of the practitioner's impairment to determine an appropriate course of action; (2) Review documentation pertinent to the impairment which has been made available to the Committee; (3) Make appropriate referrals for: (a) Evaluation; (b) Treatment; or (c) Rehabilitation; and (4) Design, or request a treatment entity to design, a program that is generally accepted by an insurer which allows an impaired practitioner to practice mortuary science in a competent manner. #### Regulation .04 Criteria. *COMAR 10.29.13.04* A. Admission to the program may be the result of: (1) Self-referral; (2) Formal complaint; or (3) Referral by the Board. B. If participation in the program is a result of a voluntary action by an impaired practitioner, which results in a formal agreement with the Committee to undergo a course of treatment or rehabilitation, the Committee shall report to the Board only noncompliance with the agreement. C. The Committee may not report to the Board those impaired practitioners who self-refer or who come to the attention of the Committee by a formal complaint if those practitioners comply with the formal agreement or program. D. The Committee shall report to the Board any noncompliance with the treatment program, if the Board referral is the result of a public or nonpublic order or informal discipline imposed by the Board. E. The impaired practitioner for whom the program was designed shall pay all costs associated with the evaluation, treatment, and rehabilitation program. ### Chapter 14 — Compelling Purpose Disclosure **Authority:** General Provisions Article, §4-333; Health Occupations Article, §7-205; Annotated Code of Maryland **Administrative History:** Effective date: April 15, 2002 (29:7 Md. R. 621) #### Regulation .01 Scope. *COMAR 10.29.14.01* A. This chapter permits the Board to disclose investigative information to other agencies, or other entities, or both, under certain circumstances. B. A custodian may disclose information in a licensing or investigative file if the custodian determines that a compelling public purpose exists to warrant disclosure. #### Regulation .02 Disclosure for Compelling Public Purpose. *COMAR 10.29.14.02* The custodian may find that a compelling public purpose warrants disclosure of information in a licensing or investigative file, regardless of whether there has been a request for the information, and may disclose the information under the following circumstances: A. The information concerns possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority; B. The information concerns a possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or C. The information concerns conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges. #### Regulation .03 Other Disclosures. *COMAR 10.29.14.03* This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law. ### Chapter 15 — Family Security Trust Fund **Authority:** Health Occupations Article, §§7-4A-01, 7-4A-03(h), 7-4A-04—7-4A-13, Annotated Code of Maryland **Administrative History:** Effective date: April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .02B amended effective April 9, 2018 (45:7 Md. R. 345) **Administrative History:** Regulation .03 amended effective April 9, 2018 (45:7 Md. R. 345) **Administrative History:** Regulation .04 amended effective April 9, 2018 (45:7 Md. R. 345) **Administrative History:** Regulation .05 amended effective April 9, 2018 (45:7 Md. R. 345) **Administrative History:** Regulation .07 amended effective April 9, 2018 (45:7 Md. R. 345) **Administrative History:** Regulation .08A amended effective April 9, 2018 (45:7 Md. R. 345) #### Regulation .01 Scope. *COMAR 10.29.15.01* A. This chapter governs the collection of fees from licensed funeral establishments for claimants to recover compensation from the Family Security Trust Fund for an actual pre-need trust fund loss that occurred in this State due to theft, embezzlement, false pretenses, forgery, fraud, or misrepresentation by a licensed mortician, funeral director, or holder of a surviving spouse license. B. This chapter applies to all preneed contracts entered into by a licensed mortician, funeral director, or a holder of a surviving spouse license with a buyer, including those preneed contracts arranged on behalf of a holder of a corporate license. #### Regulation .02 Definitions. *COMAR 10.29.15.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Advisory Committee” means a committee comprised of three Board members and a representative from two of the trade associations which is assisted by Board Counsel provided by the Attorney General’s Office and Board Administrative personnel to administer the Fund. (2) “Board” means the Maryland State Board of Morticians and Funeral Directors. (3) “Claim” means a request filed in writing, under oath, with supporting documentation by a claimant to obtain compensation from the Family Security Trust Fund for a preneed trust fund loss as a result of malfeasance, default, failure, or insolvency of any licensee under Health Occupations Article, §7-4A-06, Annotated Code of Maryland. (4) “Claimant” means an individual, or legal representative of the individual who files a claim for loss. (5) “Final order” means a public record issued by the Board resolving a contested case either by consent or after an adjudication, which includes findings of fact, conclusions of law, and a disposition which: (a) Denies a license; (b) Sanctions by reprimand, probation, fine, or suspension or revocation of a license; (c) Summarily suspends a license; (d) Dismisses charges; (e) Surrenders a license; or (f) Takes any other action that the Board may do by law. (6) “Fund” means the Family Security Trust Fund, a special, nonlapsing, interest bearing account. (7) “Preneed contract” means an agreement entered into by a licensed mortician, a licensed funeral director, or a holder of a surviving spouse license with a supervising mortician or a supervising funeral director with a buyer in advance of the death of that individual or beneficiary. (8) “Seller” means a licensed mortician or licensed funeral director who agrees to sell certain mortuary sciences services or merchandise in a contractual arrangement between a buyer and a funeral establishment. #### Regulation .03 Mandatory Fees. *COMAR 10.29.15.03* A. A licensed funeral establishment may not be exempt from the fees outlined in this regulation. B. The Board shall send out fee notices to the licensed establishments via first class mail or by any electronic means by September 1. C. Annual payments shall be due on November 30 of every year. All active licensed establishments shall be required to pay a fee of $375 to the Family Security Trust Fund. D. A late fee of $500 will be assessed on December 1 for any licensed establishment that is delinquent in paying the mandatory contribution to the Fund. E. If the establishment does not pay the mandatory fee and the late fee by December 30, the Committee shall refer the delinquent establishments to the Board for formal action to include possible suspension of the supervising mortician license. F. In addition to any applicable mandatory late fee, the Board: (1) Shall assess a $40 fee for returned checks; and (2) May not issue a license until the payment is made, including the late fee if after December 1. G. A licensee is not entitled to a refund of its contribution to the Fund. H. Mandatory contributions to the Fund may not be prorated. #### Regulation .04 The Family Security Trust Fund. *COMAR 10.29.15.04* A. The Board shall: (1) Collect the mandatory contributions; (2) Deposit the funds; (3) Track interest; and (4) Process claims for loss that occurred on or after January 1, 2010. B. All fees shall be deposited with the State Treasurer into a separate account known as the Family Security Trust Fund. The Fund may not be transferred to or revert to the General Fund of the State. C. All moneys deposited in the Fund shall be used only for the purposes expressly authorized by Health Occupations Article, §7-04A-05, Annotated Code of Maryland. D. The Fund shall accumulate interest income which shall be credited to the Fund. E. Once the Fund has accumulated a balance of $1,000,000 the Board shall cease to collect the annual fee. F. If the Fund falls below $1,000,000, the Board shall reinstate a fee up to $375 to be assessed by the Board. G. The Fund shall be maintained at $1,000,000 principal level plus interest. H. The Board may expend monies in the Fund for the following purposes: (1) To make reimbursements on approved claims; and (2) To pay the expenses of the Board for administering the Fund, including appropriate experts, or legal counsel, accountants, consultants, and agents. #### Regulation .05 Filing a Claim. *COMAR 10.29.15.05* A. Complaints shall be processed pursuant to COMAR 10.29.11. B. The Board shall issue a final order against a licensee for violation involving a transaction that relates to preneed funeral planning that occurred in the State and falls within its jurisdiction. C. The claimant shall: (1) Complete a claim form devised by the Board; (2) Provide a signed preneed contract and copies of documentation of any and all money transactions regarding the preneed contract; and (3) Present all claims for losses to the Board within 1 year: (a) After the death of the person who is the subject of the preneed contract; (b) Upon the discovery by the claimant of the defalcation; or (c) At a later date at the discretion of the Board. D. The Board shall consider each claim on a case by case basis. E. All claims shall be filed with the Fund. F. Claims shall be filed in accordance with Health Occupations Article, §§7-4A-07—7-4A-08, Annotated Code of Maryland. #### Regulation .06 Hearings. *COMAR 10.29.15.06* Hearings shall be conducted in accordance with Health Occupations Article, §7-319, Annotated Code of Maryland. #### Regulation .07 Restitution. *COMAR 10.29.15.07* A. A claimant may receive compensation from the Fund for an actual preneed trust fund loss that occurred on or after January 1, 2010. All payments shall be a matter to be decided by the full Board in its discretion. B. Restitution may only be obtained from the Fund if adequate funds are not available from the preneed seller. C. The amount of compensation recoverable by a claimant shall be restricted to the actual monetary loss incurred by the claimant. D. The President of the Board shall sign claims by designation to appropriate staff for payment from the Fund. E. The Board shall order full or partial payment of a claim. F. If at any time there are not sufficient funds on hand to pay all claims in full, the Board may, in its discretion, pay the approved claims pro rata or defer payment until such time as adequate funds are available. G. The Board shall determine the maximum cumulative amounts which shall be paid in respect to any one claim or multiple claims by a single claimant arising from the same licensee involved in either a client or fiduciary relationship. The percentage of payment on the dollar remains the same for all victims of the same licensee. #### Regulation .08 Recovery of Funds. *COMAR 10.29.15.08* A. In the event restitution is made to a claimant under this chapter, the Board may bring action to the extent authorized by statute against any person, including a licensee who is determined by the Board to be responsible for the claim. B. A licensee found guilty of malfeasance, misfeasance, default, failure, or insolvency may not be considered for reinstatement to an active status until all money paid from the fund is repaid in full, plus interest from the time the payment is made. ### Chapter 16 — Crematories — Definitions **Authority:** Business Regulation Article, §5-101; Health-General Article, §5-508; Health Occupations Article, §§7-101, 7-102, and 7-205, Annotated Code of Maryland **Administrative History:** Effective date: April 14, 2014 (41:7 Md. R. 421) **Administrative History:** Regulation .02 amended effective May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Scope. *COMAR 10.29.16.01* This chapter defines terms used in COMAR 10.29.17 — COMAR 10.29.20. #### Regulation .02 Definitions. *COMAR 10.29.16.02* A. In COMAR 10.29.17 — COMAR 10.29.20, the following terms have the meanings indicated. B. Terms Defined. (1) “Advertising” means the publication, dissemination, or circulation of any oral or written matter, including labeling, which directly or indirectly calls to the attention of the public the goods and services one has to offer. (2) “Alkaline hydrolysis” means the process of reducing human remains using water, alkaline chemicals, and heat inside a watertight vessel to accelerate decomposition. (3) “Authorizing agent” means an individual who has legal authority to arrange for and make decisions regarding the final disposition of human remains, including cremation or alkaline hydrolysis. (4) “Board” means Board of Morticians and Funeral Directors. (5) “Consumer” includes a funeral establishment contracting with a crematory or the authorizing agent of a decedent contracting with a crematory. (6) “Cremated human remains” means the recoverable bone fragments of a deceased person that result from the completion of cremation. (7) “Cremation” means the disposition of a dead human body by means of incineration. (8) “Cremator” means the machinery within which the process of cremation begins. (9) “Crematory” means a building, portion of a building, or structure that houses the necessary appliances and facilities for cremation, alkaline hydrolysis, or both. (10) “Crematory container” means a readily combustible, rigid container in which human remains are sent to the crematory and then placed in the cremator for cremation. (11) “Crematory equipment” means either: (a) A cremator; or (b) A hydrolysis unit. (12) “Decedent” means a dead human being. (13) “Embalming” means the disinfection and preserving of human remains by arterial or cavity injection or any other type of preservation. (14) “Engage in the operation of a crematory” means controlling or managing a crematory. (15) “Holding facility” means an area, within or adjacent to a crematory, designed for the retention of human remains before cremation or alkaline hydrolysis. (16) Human Remains. (a) “Human remains” means: (i) The body of a deceased person; or (ii) A part of a body or limb that has been removed from a living person. (b) “Human remains” includes the body or part of a body or limb in any state of decomposition. (17) “Hydrolysis container” means a container, including a body bag, in which human remains are sent to the crematory for alkaline hydrolysis, but the human remains may be removed prior to the start of the process for alkaline hydrolysis. (18) “Hydrolysis unit” means the watertight vessel in which the process of alkaline hydrolysis occurs. (19) “Hydrolyzed human remains” means the recoverable bone fragments of a deceased person that result from the completion of alkaline hydrolysis. (20) “Office” means the Office of Cemetery Oversight. (21) “Permit” means a license issued by the Board to allow a person to operate a business which engages in the operation of a crematory or to act as a registered crematory operator. (22) “Permit holder” means the holder of a permit issued under Health Occupations Article, Title 7, Annotated Code of Maryland, to operate a crematory or to act as a registered crematory operator. (23) “Person” means an individual, personal representative, or a corporation that is the operator of a mortuary science business where the practice of mortuary science is conducted for the corporation by a licensed mortician or funeral director, a partnership, or professional association, each comprised of one or more licensed morticians or funeral directors. (24) “Processed human remains” means the end result of pulverization. (25) “Pulverization” means the process following cremation or alkaline hydrolysis of crushing, grinding, or milling cremated or hydrolyzed human remains into fine particles or powder, leaving bone fragments reduced to 5 millimeters or less. (26) “Registered crematory operator” means an individual registered to operate a crematory as a sole proprietor or on behalf of a sole proprietor or permit holder. (27) “Responsible party” means a sole proprietor or the individual designated by a corporation, limited liability company, or partnership, which holds a permit to engage in the operation of a crematory, to be responsible for the operations of the crematory. (28) “Sealable container” means a container in which processed human remains can be placed and sealed so as to prevent leakage of the processed human remains or the entry of any foreign material. ### Chapter 17 — Crematories — Permit, Licensing, and Fees **Authority:** Business Regulation Article, §§5-101, 5-204, and 5-303; Health Occupations Article, §§1-213, 7-101, 7-102, 7-205, 7-314—7-316, and 7-319, Annotated Code of Maryland **Administrative History:** Effective date: April 14, 2014 (41:7 Md. R. 421) **Administrative History:** Regulation .02C adopted as an emergency provision effective August 28, 2014 (41:19 Md. R. 1075); adopted permanently effective November 10, 2014 (41:22 Md. R. 1319) **Administrative History:** Regulation .02B amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .03B amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .04 amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .06A, B, E amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .07B amended effective May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Scope. *COMAR 10.29.17.01* This chapter governs the crematory permit process and fees for persons regulated under Health Occupations Article, Title 7, Annotated Code of Maryland. #### Regulation .02 Permit — Issuing Agency. *COMAR 10.29.17.02* A. Office of Cemetery Oversight. An individual shall obtain a permit to engage in the operation of a crematory from the Office: (1) If the individual: (a) Holds a permit or registration under Business Regulation Article, Title 5, Annotated Code of Maryland; and (b) Owns a greater interest in a crematory than a licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland; (2) If the person’s ownership interest is equal to the ownership interest in the crematory of a licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland; or (3) If the person who owns the crematory is not: (a) A licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland; or (b) A registrant or permit holder under Business Regulation Article, Title 5, Annotated Code of Maryland. B. A permit issued by the Office shall specify whether the crematory is authorized to offer and perform either cremation services, alkaline hydrolysis services, or both. C. Board of Morticians and Funeral Directors. A person shall obtain a permit to engage in the operation of a crematory from the Board if the person: (1) Is a licensee or holder of a corporation license under Health Occupations Article, Title 7, Annotated Code of Maryland; and (2) Owns a greater interest in a crematory than a person who holds a permit or registration under Business Regulation Article, Title 5, Annotated Code of Maryland. D. Before obtaining a permit from the Board, a crematory may cremate or hydrolyze the human remains of one decedent provided the: (1) Cremation or hydrolysis is only performed as part of the manufacturer’s operator training course for the cremation machinery or the hydrolysis unit in which the cremation or hydrolysis takes place; and (2) The person or persons with the right to final disposition of the decedent are notified and have given permission before the cremation or the alkaline hydrolysis occurs. #### Regulation .03 Permit — Requirements for Permit. *COMAR 10.29.17.03* A. Subject to approval of the Board, a person shall receive a permit to operate a crematory in this State if the person meets the permit requirements of this chapter. B. A person shall: (1) Submit an application on a form provided by the Board; (2) Pay the non-refundable application fee and any other applicable fees set forth in Regulation .08 of this chapter; (3) Be of good moral character if the applicant is an individual; (4) Designate a registered crematory operator who shall be responsible for the day-to-day operation of the business provided that the registered crematory operator may not be designated as the responsible party for more than a total of two crematories; (5) Provide a certificate of status, issued by the Maryland Department of Assessments and Taxation, if the applicant is a business entity: (a) Indicating that the entity is in good standing, or its equivalent as determined by the Board; and (b) Dated not earlier than 30 days before the application; and (6) Comply with all applicable federal, State, and local laws. C. An operating crematory shall apply to the Board for a permit within 90 days from the effective date of this regulation or be subject to Board action. D. Before applying to the Board for a permit, any crematory not in operation before the effective date of this chapter shall have in its employ an individual who holds a certification from: (1) The Cremation Association of North America (CANA); (2) The International Cemetery, Cremation and Funeral Association (ICCFA); or (3) Another equivalent body recognized jointly by the Board and the Office. #### Regulation .04 Requirements for Registration of a Registered Crematory Operator. *COMAR 10.29.17.04* A. An individual may be registered by the Board as a crematory operator if the individual meets the requirements of this regulation. B. The permit issued by the Board shall specify whether the individual’s training and registration required by this chapter permits the individual to operate a cremator, an alkaline hydrolysis unit, or both. C. An individual shall: (1) Submit an application on a form provided by the Board; (2) Pay the non-refundable fee and any other applicable fee set forth in Regulation .08 of this chapter; (3) Be of good moral character; (4) Be 18 years old or older; (5) Achieve certification as a crematory operator by the: (a) Cremation Association of North America (CANA); (b) International Cemetery, Cremation and Funeral Association (ICCFA); or (c) Other equivalent certification recognized jointly by the Board and the Office; and (6) In the crematory with which the applicant is affiliated: (a) Successfully complete the operator training course of the manufacturer of the cremator or the alkaline hydrolysis unit located in the crematory with which the applicant is affiliated; or (b) Provide a notarized letter by the supervising crematory operator for which the individual is employed indicating the completion of training on the cremator or the alkaline hydrolysis unit. D. To qualify as a trainer, the supervising crematory operator shall have a minimum of 3 years’ experience on the associated cremator or alkaline hydrolysis unit. #### Regulation .05 Change of Information. *COMAR 10.29.17.05* The permit holder or registered crematory operator shall notify the Board of any change in the information provided in the application either before or after the issuance of a permit or registration within a reasonable period of time but not to exceed 7 days from the date of the change. #### Regulation .06 Renewals. *COMAR 10.29.17.06* A. Before the expiration date of the permit or a registration, a permit holder or a registered crematory operator shall: (1) Complete and return the renewal form; (2) Pay the non-refundable renewal fee set forth in Regulation .08 of this chapter; and (3) Submit any required documentation to the Board. B. A person who has a permit or registration as a permit holder or registered crematory operator may renew the permit or registration every 2 years, beginning on a date specified by the Board, in the following manner: (1) Complete the renewal application form; (2) Pay the non-refundable renewal fee set forth in Regulation .08 of this chapter; (3) Meet the permit and registration requirements of this chapter and Health Occupations Article, Title 7, Annotated Code of Maryland; and (4) Submit the required documentation. C. After the expiration date, if an application for renewal of a permit or registration has not been made or if the individual has been identified by the Office of the Comptroller or the Maryland Department of Labor as delinquent in the payment of taxes or unemployment insurance contributions, pursuant to tax compliance regulations of COMAR 10.31.02 or, pursuant to Family Law Article, §10-119.3, Annotated Code of Maryland, has outstanding child support obligations, the individual may not engage in the operation of a crematory business or act as a registered crematory operator. D. An individual who engages in the operation of a crematory business or acts as a registered crematory operator without renewing the required permit or registration is subject to disciplinary action by the Board. E. If a permit holder or a registered crematory operator applies for renewal past the expiration date of the permit or registration, the individual shall pay the renewal fee plus the late renewal fee set forth in Regulation .08 of this chapter. #### Regulation .07 Lapsed Permit. *COMAR 10.29.17.07* A person who has been issued a permit and who has allowed the permit to lapse for at least 6 months may apply for a permit by doing the following: A. Completing a permit application form; B. Paying the permit fee and the late renewal fee set forth in Regulation .08 of this chapter; C. Meeting the permit requirements under this chapter; D. Submitting the documentation required by this chapter; E. Providing a full written explanation to the Board detailing the reasons why the permit was allowed to expire and why a permit is now sought; and F. Submitting to the Board an affidavit stating that the person did not engage in the operation of a crematory in this State while the permit was lapsed. #### Regulation .08 Fees. *COMAR 10.29.17.08* The following fees are established by the Board: A. Initial permit or registration and renewal fees: (1) Crematory permit — $350; (2) Registered crematory operator — $300; (3) Crematory permit renewal — $350; (4) Registered crematory operator renewal — $300; and (5) Late fee — $200; and B. Miscellaneous fees: (1) Replacement of permit or registration — $50; (2) Returned check fee — $50; (3) Duplicate permit or registration — $50; (4) Business name change — $50; (5) Personal name change — $50; (6) Business address change — $50; and (7) Annual pre-need sales trust report — $25. #### Regulation .09 Display of Permit. *COMAR 10.29.17.09* A permit and registration, as well as any other permit or license required by local, State, or federal agencies, shall be conspicuously displayed in a public area on the crematory premises. ### Chapter 18 — Crematories — Complaints and Disciplinary Procedures **Authority:** Health-General Article, §§5-502—5-504, 5-508, and 5-511—5-514; Health Occupations Article, §§7-101, 7-102, 7-205, 7-316, 7-317, 7-319, and 7-406, Annotated Code of Maryland **Administrative History:** Effective date: April 14, 2014 (41:7 Md. R. 421) **Administrative History:** Regulation .02 amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .03B, E amended effective May 11, 2026 (53:9 Md. R. 413) **Administrative History:** Regulation .06A amended effective May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Scope. *COMAR 10.29.18.01* This chapter governs crematory inspections, standards, the complaint process, investigations, grounds for discipline, and penalties. #### Regulation .02 Inspection by the Board. *COMAR 10.29.18.02* A. A crematory shall be available for inspection by a representative of the Board at any time during operating hours. B. A crematory shall be inspected: (1) On at least a biennial basis; (2) In furtherance of an investigation; or (3) Upon the sale or change of ownership of the crematory. C. The permit holder or any person responsible for day-to-day operation of the cremation machinery or the alkaline hydrolysis unit shall be available to accompany the inspector during the inspection and sign the initial inspection report. D. A copy of the inspection report shall be provided to the permit holder or the registered crematory operator responsible for the day-to-day operation of the crematory. E. A crematory shall maintain the following minimum standards: (1) The premises shall be maintained in a sanitary manner to comply with Centers for Disease Control’s guidelines on universal precautions; (2) Except by express written consent of the authorizing agents to perform simultaneous, multiple cremations or alkaline hydrolyses, there may not be more than one human body cremated or hydrolyzed simultaneously in a single cremator or alkaline hydrolysis unit at a time; (3) A cremator or an alkaline hydrolysis unit shall be completely cleaned after each cremation or alkaline hydrolysis; (4) There may not be co-mingling of human remains and pet remains in: (a) Refrigeration units; (b) Cremators; or (c) Alkaline hydrolysis units; (5) Separate cremators or alkaline hydrolysis units shall be dedicated for the cremation or alkaline hydrolysis of human remains and the cremation or alkaline hydrolysis of pets; (6) Except as provided in §E(2) of this regulation, there may not be: (a) Co-mingling mingling of processed human remains with other processed human remains or pet remains; (b) Scooping of processed human remains from a bucket containing co-mingled processed human remains (c) Any form of misrepresentation in the return of processed human remains; (7) Excluding a deceased person with a known communicable infection, human remains shall be properly identified before cremation or alkaline hydrolysis by verifying that the documentation accompanying the human remains is consistent with a visual observation of the human remains; (8) Burial transit permit shall be an original document pertaining to the deceased; (9) Each crematory shall have: (a) A sink with hot and cold water within the work area housing the crematory equipment; and (b) The tools necessary to thoroughly clean the floor within the work area housing the crematory equipment with water and an appropriate sanitizing agent; (10) The name of the deceased shall be visible on the outside of the crematory container; (11) Human remains shall be properly stored before cremation or alkaline hydrolysis; (12) Crematories shall: (a) Use only mechanical pulverizing equipment meeting industry standards that has been totally brushed as clean as possible between each use; and (b) Pulverize the processed human remains with a mortar and pestle if the processed human remains are not sufficient in amount for pulverizing in mechanical equipment; (13) Separate pulverizing drums shall be dedicated for processed human remains and processed pet remains; (14) Processed human remains may not be held pending payment of any fees; (15) Within 6 months of the effective date of these regulations, cremators without safety devices that prevent the automatic door from dropping unintentionally shall be retrofitted with such safety devices; (16) Portable fans may not be used in the area of the cremator; (17) There shall be a minimum of 6 inches between cremator smoke stack and the roof of the crematory; (18) Before pulverizing, the mechanical pulverizer shall be clamped; (19) A cremator shall have visible on its front a warning sign stating, “No leaning past the door of the cremator.”; (20) The permit holder or registered crematory operator shall be present at the crematory during the operation of the: (a) Cremator; (b) Alkaline hydrolysis unit; or (c) Pulverizer; and (21) All individuals: (a) Who operate the cremator or the alkaline hydrolysis unit in a crematory shall be certified by the Cremation Association of North America (CANA), International Cemetery, Cremation, and Funeral Association (ICCFA), or other equivalent certification recognized jointly by the Board and the Office; and (b) Receiving training toward certification to operate a cremator or an alkaline hydrolysis unit shall be allowed to work under the supervision of a registered crematory operator who has the required certification for a period of at least 6 months. F. The following completed forms from previous cremations or alkaline hydrolysis shall be available at all times for inspection and copying and are subject to be pulled at random by the inspector: (1) Crematory services authorization form; (2) Burial transit permit; (3) Delegation of authority form; (4) Receipt for human remains; (5) Record of cremation or alkaline hydrolysis; (6) Certificate of cremation or alkaline hydrolysis; and (7) Return of processed human remains certificate. G. Inspection results shall be written on forms approved by the Board. H. The Board representative performing the inspection shall, on completion of the inspection: (1) Apprise the permit holder of the findings of the inspection; and (2) Provide the permit holder or representative of the permit holder with a copy of the inspection report. I. The permit holder or representative of the permit holder shall sign and verify receipt of the inspection report. J. At the time of the Board inspection, the permit holder shall provide written documentation to the Board’s inspector that: (1) The crematory equipment has been inspected in accordance with manufacturer specifications; (2) In accordance with manufacturer specifications, it is not time for a manufacturer’s inspection; or (3) The permit holder has requested that the manufacturer conduct an inspection of the crematory equipment. #### Regulation .03 Crematory Inspection Report, Deficiencies, and Penalties. *COMAR 10.29.18.03* A. The Board shall review the inspection report and make a determination as to whether a deficiency exists. B. The Board shall notify the permit holder of the results of the inspection by providing a copy of the inspection report for the permit holder. C. If a permit holder passes an inspection, the permit holder shall, prominently and in public view, display on the premises a statement issued by the Board that the crematory has successfully passed an inspection. D. If the Board finds a deficiency, the Board shall: (1) Within 7 days, notify the permit holder of the deficiency or failure to pass the inspection; and (2) Provide a copy of the inspection report to the permit holder within 30 days. E. Correction of Deficiency. (1) Except as provided in this section, a permit holder shall correct a deficiency within 30 days after receipt of notification or sooner as determined by the Board. (2) The Board may require immediate correction of a deficiency if the Board considers the correction necessary in the interest of public health. (3) The permit holder may request an extension of time for correction of a deficiency. (4) The Board may approve an extension of time for correction of a deficiency. (5) Upon completion of correction of all deficiencies, the permit holder shall notify the Board. (6) Upon notification from the permit holder, a representative of the Board shall re-inspect the crematory. (7) The Board shall notify the permit holder in writing of the results of the re-inspection by providing a copy of a new inspection report to the permit holder. (8) If re-inspection reveals additional deficiencies not cited in the first report, the permit holder shall correct those deficiencies in the time period specified by the Board unless an extension of time is requested by the permit holder and approved by the Board. F. Penalties. In the event that a permit holder fails to allow an inspection of the crematory or fails to comply with a notice to correct deficiencies or violations within the time specified, the Board shall: (1) Deem the failure to be a threat to the public health, safety, or welfare and requiring emergency action; (2) Summarily suspend the crematory permit as provided under State Government Article, §10-226(c)(2), Annotated Code of Maryland; (3) Provide notice of the Board’s action to the permit holder; and (4) Provide the permit holder an opportunity to be heard. #### Regulation .04 Complaints. *COMAR 10.29.18.04* A. If the permit holder was issued a permit by the Board, a complaint shall be: (1) Filed in compliance with the provisions of COMAR 10.29.11.03; and (2) Processed in accordance with the provisions of COMAR 10.29.11.04. B. The Board may initiate a complaint or investigation on its own. #### Regulation .05 Investigations. *COMAR 10.29.18.05* The Board and the Office of Cemetery Oversight may share investigative information and conduct joint investigations. #### Regulation .06 Grounds for Discipline, Hearing, and Penalties. *COMAR 10.29.18.06* A. Pursuant to the provisions of Health Occupations Article, §§7-316 and 7-319, Annotated Code of Maryland, the Board may: (1) Deny an applicant: (a) A crematory permit; or (b) A crematory operator registration; (2) Reprimand any: (a) Permit holder; or (b) Registered crematory operator; or (3) Suspend or revoke: (a) A crematory permit; or (b) A crematory operator registration. B. Pursuant to the provisions of Health Occupations Article, §7-317, Annotated Code of Maryland, if the Board, after bringing an action, finds that there are grounds for probation, suspension, or revocation, the Board may impose a penalty not exceeding $5,000. ### Chapter 19 — Crematories — Crematory Procedures **Authority:** Health-General Article, §§5-502—5-504, 5-508, and 5-511—5-514; Health Occupations Article, §§7-101, 7-102, and 7-205, Annotated Code of Maryland **Administrative History:** Effective date: April 14, 2014 (41:7 Md. R. 421) **Administrative History:** Chapter revised effective May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Scope. *COMAR 10.29.19.01* This chapter governs the procedures to be followed in performing a cremation or alkaline hydrolysis in this State. #### Regulation .02 Removal, Identification, and Transportation of Human Remains. *COMAR 10.29.19.02* A. Upon receipt of human remains, a permit holder in the presence of the authorizing agent or representative of the funeral establishment engaging crematory services shall: (1) Verify that the information on the wrist tag is consistent with the: (a) Documentation accompanying the deceased; and (b) Visual observation of the remains themselves; (2) Use a metal detector wand to inspect for the presence of any battery operated, implanted devices including pacemakers, defibrillators, or pain relief devices; (3) Refuse to accept human remains for cremation if an inspection of the human remains indicates the presence of any battery operated, implanted device; (4) Ensure the removal and properly dispose of any hazardous object or any other materials that the individual authorized under this subtitle deems should be removed from the human remains, the crematory container, or the hydrolysis container, in order to prevent harm to the public health or damage to the cremator or alkaline hydrolysis unit; (5) Remove any jewelry: (a) On the human remains; (b) In the crematory container; or (c) In the hydrolysis container; (6) Return any removed jewelry to the authorizing agent or representative of the funeral establishment engaging crematory services; and (7) Obtain a signed, itemized receipt from the authorizing agent or representative of the funeral establishment engaging crematory services for the removed jewelry and retain the receipt as a permanent record. B. Foreign objects removed from the human remains: (1) Shall be treated as medical waste and disposed of accordingly; and (2) May not be donated until a sterilization process through a third party recognized by the Board to dispose properly of medical waste has been performed. C. Materials identifying the human remains that are placed in the custody of a permit holder shall contain the following information about the decedent: (1) Name; (2) Date of birth; (3) Date of death; (4) Name of funeral establishment or authorizing agent; (5) Gender; and (6) Name and relationship of authorizing agent to deceased. D. A permit holder may not accept unidentified human remains for cremation or alkaline hydrolysis. #### Regulation .03 Crematory and Hydrolysis Containers. *COMAR 10.29.19.03* A. A crematory container: (1) Shall be a readily combustible, rigid container suitable for cremation; (2) Shall provide a completely enclosed covering for the human remains; (3) Shall be resistant to leakage or spillage; (4) Shall be of sufficient strength and rigidity for ease of handling; (5) Shall provide protection to the health and safety of crematory establishment personnel and the public; (6) Shall comply with all local, State, and federal governmental emissions regulations; (7) May not be composed of metal or polyethylene material; and (8) Which appears to be heavily coated with varnish, lacquer, or any other highly combustible substance, shall be: (a) Placed in a cold cremator; or (b) Coated completely with water before being placed in the cremator. B. An alkaline hydrolysis container: (1) Shall consist of a completely enclosed covering for the human remains; (2) Shall be resistant to leakage or spillage; (3) Shall provide protection to the health and safety of the crematory establishment personnel and the public; (4) Shall comply with all local, State, and federal emissions regulations; and (5) Once inside the alkaline hydrolysis unit, may be removed prior to the start of the alkaline hydrolysis process as long as the human remains are covered to protect the dignity of the decedent. #### Regulation .04 Holding Facilities. *COMAR 10.29.19.04* A holding facility shall: A. Comply with applicable public health laws; B. Preserve the dignity of human remains; C. Recognize the integrity, health, and safety of crematory establishment personnel; and D. Be secure from access by unauthorized persons. #### Regulation .05 Holding Remains. *COMAR 10.29.19.05* A. Unless prevented by emergency circumstances, human remains that have been designated for cremation or alkaline hydrolysis shall be cremated or hydrolyzed by a permit holder within 48 hours after receipt. B. A permit holder may not hold human remains for cremation or alkaline hydrolysis unless the human remains are contained within an individual, closed cremation or hydrolysis container as required under Regulation .03 of this chapter. C. A permit holder may not accept a cremation or alkaline hydrolysis container from which there is any evidence of leakage of the body fluids from the human remains therein. D. Whenever a permit holder is unable to cremate or hydrolyze human remains within 48 hours of taking custody thereof due to emergency circumstances, the permit holder shall maintain the human remains in a refrigerated holding facility, either on or off site, at 40°F or less, unless the remains have been embalmed. #### Regulation .06 Identification of Human Remains Immediately Before Cremation or Alkaline Hydrolysis. *COMAR 10.29.19.06* A. Immediately before being placed within the cremator or the alkaline hydrolysis unit, the individual authorized under this subtitle shall: (1) Verify the identification of the human remains; and (2) Place in or on the cremator or the alkaline hydrolysis unit the hard metal or plastic identification disc of the human remains being processed where it shall remain in place until the cremation or the alkaline hydrolysis process is complete. B. The permit holder’s designee may not leave the: (1) Immediate area of the cremator during the cremation process; or (2) Facility for the alkaline hydrolysis unit during the alkaline hydrolysis process. C. The alkaline hydrolysis unit shall be monitored at all times during the alkaline hydrolysis process. D. Records. (1) The permit holder shall maintain the written authorizations required by Regulation .08 of this chapter as required pursuant to Health-General Article, §4-304, Annotated Code of Maryland, and COMAR 10.01.16.04B. (2) The records are subject to inspection and copying by the Board. #### Regulation .07 Crematory Services Authorization. *COMAR 10.29.19.07* A. Except as otherwise provided in COMAR 10.29.18.02, a permit holder may not cremate or hydrolyze human remains until: (1) The body has been identified as required under Health Occupation Article, §7-411, Annotated Code of Maryland; (2) The permit holder crematory has received: (a) A crematory services authorization on a form approved by the Board and signed by an authorizing agent; (b) If applicable, a written delegation document or facsimile; and (c) Any other documentation required by federal, State, or local law; and (3) The permit holder has documented that at least 12 hours have elapsed from the time of death of the individual prior to beginning cremation or alkaline hydrolysis. B. The crematory services authorization form shall: (1) Be provided by the permit holder to the authorizing agent; (2) Contain the following information: (a) The identity of the decedent; (b) Date of death; (c) The name and address of the authorizing agent and the relationship between the authorizing agent and the deceased; (d) Authorization for the permit holder to cremate or hydrolyze the human remains; (e) An indication of whether the decedent is: (i) A veteran, as defined in State Government Article, § 9-901, Annotated Code of Maryland; or (ii) An eligible dependent of a veteran, as defined in Business Regulation Article, §5-803, Annotated Code of Maryland; (f) Authorization to verify that the following have been removed before cremation or alkaline hydrolysis: (i) An implanted pacemaker or defibrillator; and (ii) Any other materials that should be removed to prevent harm to the public health or damage to equipment; (g) A representation by the authorizing agent that radiologic implant treatment has not occurred within 5 days before cremation or alkaline hydrolysis; (h) A representation that the authorizing agent is aware of no objection to the human remains being processed by any person who has a right to control the disposition of the human remains; (i) The name and address of the person authorized to claim the processed human remains from the permit holder or to accept the processed remains via registered mail; and (j) The name and address of the crematory to which the authorizing agent has given permission; and (3) Be signed by the authorizing agent. C. If an authorizing agent is not readily available to execute the crematory services authorization form, the authorizing agent may transmit the document in writing with notary seal electronically: (1) In writing; or (2) If located outside the area, by transmitting to the permit holder: (a) A signed statement electronically or by facsimile that contains the name, address, and relationship of the sender to the decedent and the name and address of the individual to whom authority is delegated; and (b) Once the authorizing agent is located in the area, a notarized document through U.S. Postal Service attesting to the delegation of authority. D. Upon receipt of the written delegation document or a copy transmitted electronically or by facsimile, the permit holder shall allow the named individual to serve as the authorizing agent. The documents shall be signed by the authorizing agent in the presence of a notary. E. A person signing a crematory services authorization form is deemed to warrant the truthfulness of any facts set forth in the crematory services authorization form, including the identity of the deceased whose remains are sought to be processed and the authority of that person to order such a cremation or alkaline hydrolysis. F. A permit holder shall notify and obtain written consent of the authorizing agent before the cremation or the alkaline hydrolysis of human remains at a location other than the location named on the crematory services authorization form. G. A permit holder shall maintain a copy of every crematory services authorization form required under this regulation as permanent records. H. Crematory services authorization records are subject to inspection and copying by the Board. #### Regulation .08 Record of Receipt of Remains. *COMAR 10.29.19.08* A. A permit holder shall provide to an individual who delivers human remains for cremation or alkaline hydrolysis a receipt signed by both the permit holder authority and the individual who delivered the human remains, that includes the: (1) Name of the individual from whom the human remains were received and the name of the individual’s employer, if any; (2) Name and address of the crematory; (3) Name of the deceased; (4) Gender of the deceased; (5) Date of death of the deceased; and (6) Verification of the authorized burial transit permit. B. The permit holder shall maintain a record of each cremation or alkaline hydrolysis, which shall include the: (1) Name of the decedent; (2) Date of birth of the decedent; (3) Gender of the decedent; (4) Date of death; (5) Name and address of the authorizing agent; (6) Date, time, and location of cremation or alkaline hydrolysis; and (7) Name of the individual who performed the cremation or the alkaline hydrolysis. C. The permit holder shall provide a certificate of disposition of processed human remains to the authorizing agent or funeral establishment that arranged for the cremation or the alkaline hydrolysis that includes the: (1) Name of the decedent; (2) Name of the authorizing agent; (3) Name and address of the person who received the processed human remains from the permit holder; and (4) If ascertainable: (a) The location, including the name of the cemetery and plot location if the remains are interred; and (b) The manner and date of the disposition of the processed human remains. D. The permit holder shall maintain a copy of every record and receipt required by this chapter as permanent records. E. All records and receipts required by this chapter are subject to inspection and copying by the Board. #### Regulation .09 Use of a Casket; Embalming. *COMAR 10.29.19.09* A. Except as provided in §B of this regulation, a permit holder may not: (1) Require that human remains be placed in a casket before cremation or that human remains be cremated in a casket; (2) Refuse to accept human remains for cremation because the remains are not in a casket; or (3) Refuse to accept human remains for cremation because the remains are in a suitable, combustible wooden casket, but may require the authorizing agent or funeral establishment engaging the services of the crematory authority to remove the metal mattress holder in the casket. B. Human remains delivered to a crematory establishment may not be removed from the cremation container. C. The cremation container shall be cremated with the human remains unless the authorizing agent for the deceased requests a more natural environment for the deceased. A permit holder is not required to accept this manner of disposition. D. A permit holder may not require that human remains be subjected to embalming before cremation. #### Regulation .10 Disposition of Processed Human Remains. *COMAR 10.29.19.10* A. On completion of the cremation or the alkaline hydrolysis, insofar as is possible: (1) All of the recoverable residue of the cremation or the alkaline hydrolysis process shall be: (a) Removed from the cremator or the alkaline hydrolysis unit; (b) Except for medical devices remaining after cremation or alkaline hydrolysis, pulverized; and (c) Placed in a sealable container; and (2) The identification disc required by Health Occupations Article, §7-411, Annotated Code of Maryland, shall be: (a) Removed from the cremator or the alkaline hydrolysis unit; and (b) Placed in the sealable container with the processed human remains. B. Medical devices which remain after the completion of the cremation or the alkaline hydrolysis process shall be treated as medical waste and disposed of accordingly. C. After pulverization, all of the processed human remains, together with the identification disc, shall be placed in a sealable container. D. If the sealable container opening is not of adequate dimensions to accommodate a disc, it shall be affixed to the exterior of the sealable container and a record of the cremation number shall be placed in the sealable container. E. If all of the processed human remains and the identification disc will not fit within the dimensions of a sealable container, the remainder of the remains shall be returned to the authorizing agent, or the agent’s representative, in a separate, sealable container. Container seams shall be taped. F. If the processed human remains and identification disc do not adequately fill the container’s interior dimensions, the extra space may be filled with packing material that will not become intermingled with the remains and then securely closed. G. If a sealable container is to be shipped, it shall: (1) Be placed within a separate sturdy box with all box seams securely taped closed; and (2) Have the name of the deceased person whose processed remains are contained therein clearly identified on the outside of the container. H. If processed human remains have been in the possession of a permit holder, as originally authorized by the authorizing agent without instructions for disposition for a period of 10 days or more from the date of cremation or alkaline hydrolysis, the permit holder may send the processed human remains, using the current mailing standard approved by the U.S. Postal Service, return receipt requested, to the authorizing agent. I. Veteran and Eligible Dependent Decedents. (1) Unless the authorizing agent directs otherwise, if a permit holder in possession of processed remains of a decedent veteran or a decedent eligible dependent, the permit holder shall provide the decedent’s identifying information to a veterans service organization, as defined in Business Regulation Article, §5-803, Annotated Code of Maryland. (2) The veterans service organization will notify the permit holder whether the decedent is a veteran or an eligible dependent eligible for burial in a veterans cemetery. (3) If the unclaimed processed remains are those of a veteran or an eligible dependent, the permit holder may transfer the processed remains to a veterans service organization for the purpose of disposition of the processed remains. (4) If a veterans service organization does not take possession of unclaimed processed remains that qualify for a plot in a State veterans cemetery under State Government Article, §9-906, Annotated Code of Maryland, within 10 days after the permit holder receives the notification required in this regulation, the permit holder shall: (a) Notify the Department of Veterans and Military Families of the status of the processed remains for the purpose of the appropriate disposition of the processed remains; and (b) Transfer the processed remains to the Department of Veterans and Military Families for the purpose of the appropriate disposition of the processed remains. #### Regulation .11 Tools. *COMAR 10.29.19.11* A. A crematory offering cremation shall maintain, at its own expense, the following tool inventory: (1) Safety placement tool measuring a minimum of 49 inches in length; (2) Wire brushes for cleaning cremators; (3) Brush with fine bristles for cleaning pulverizers; (4) Mortar and pestle; (5) Funnel; (6) High temperature protective gloves and heat-resistant leather gloves; (7) Hand magnet and metal detector wand to detect and remove metal from cremated human remains; (8) Tweezers to remove nonmetal objects from cremated human remains; and (9) National Institute for Occupational Safety and Health certified N95 filtering facepiece respirators. B. A crematory offering alkaline hydrolysis shall maintain, at its own expense, the following tool inventory: (1) Suitable tools for cleaning the alkaline hydrolysis unit; (2) Brush with fine bristles for cleaning pulverizers; (3) Mortar and pestle; (4) Funnel; (5) Hand magnet and metal detector wand to detect and remove metal from hydrolyzed human remains; (6) Tweezers to remove nonmetal objects from hydrolyzed human remains; (7) National Institute for Occupational Safety and Health certified N95 filtering facepiece respirators; and (8) An emergency shower and eyewash combination unit meeting the criteria established under the American National Standards Institute and the International Safety Equipment Association Z358.1-2014 (R2020) or its successor. #### Regulation .12 Visitors. *COMAR 10.29.19.12* A. The permit holder or the designated crematory operator shall: (1) Submit to the Board the number of persons not affiliated with the operations of the crematory who can safely be within the same room and within 10 feet of the cremator door or the alkaline hydrolysis unit; and (2) Verify to the Board that the permit holder has submitted the information required in §A(1) of this regulation to their liability insurance carrier. B. Crematories that begin operation after July 1, 2014, shall construct a viewing room in the area of the cremator if the crematory intends to have more than two visitors present in the area of the cremator during the cremation. C. Crematories providing alkaline hydrolysis shall construct a viewing room in the area of the alkaline hydrolysis unit if the crematory intends to have more than two visitors present in the area of the alkaline hydrolysis unit during the alkaline hydrolysis. ### Chapter 20 — Crematories — Code of Ethics **Authority:** Health Occupations Article, §7-101, Annotated Code of Maryland **Administrative History:** Effective date: April 14, 2014 (41:7 Md. R. 421) **Administrative History:** Regulation .02C amended effective May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Scope. *COMAR 10.29.20.01* This chapter governs any person who holds a permit to: A. Engage in the operation of a crematory; B. Act as a designated crematory operator;or C. Act as a registered crematory operator. #### Regulation .02 General Professional Practices. *COMAR 10.29.20.02* A. A permit holder or registered crematory operator shall: (1) Act in a manner that respects and protects the dignity of a decedent and the decedent’s family; (2) Conduct business in a reasonable, usual, and customary manner avoiding unfair trade practices; (3) Comply with the State public health laws as set forth in Health-General Article, §§4-215 and 5-501, Annotated Code of Maryland; (4) Comply with the Maryland Morticians and Funeral Directors Act, Health Occupations Article, Title 7, Annotated Code of Maryland; (5) Implement and follow through on all arrangements agreed on between consumer and the crematory; (6) Provide appropriate services for and respect the rights of individuals without regard to age, race, creed, national origin, gender, disability, marital status, political belief, religious affiliation, social or economic status, or social preferences; (7) Comply with all local, State, and federal laws regarding the final disposition of human remains; (8) Be sensitive and responsive to the bereavement needs of a decedent’s family; and (9) Provide a general price list in effect at that time in accordance with the Federal Trade Commission’s funeral rule, 16 CFR part 453. B. In advertising, a licensee may not include statements: (1) That are misrepresentations of facts; (2) That are likely to mislead or deceive because, in context, the statement makes only a partial disclosure of relevant facts; (3) Relating to fees without reasonable disclosure of all relevant variables so that the statement would not be misunderstood or be deceptive to a consumer; or (4) Containing representations or implications that in reasonable probability can be expected to cause an ordinarily prudent individual to misunderstand or be deceived. C. A permit holder or crematory operator may not: (1) Use, or participate in the use of, any form of communication to consumers containing a false, fraudulent, misleading, deceptive, or unfair statement or claim; or (2) Operate a crematory, or perform a cremation or alkaline hydrolysis while under the influence of alcohol, an illegal drug, or a controlled dangerous substance, without the prescription of a physician. ### Chapter 21 — Mortuary Transport Services **Authority:** Health-Occupations Article, §§7-101 and 7-601 — 7-607, Annotated Code of Maryland **Administrative History:** Effective date: February 17, 2014 (41:3 Md. R. 202) #### Regulation .01 Scope. *COMAR 10.29.21.01* This chapter applies to: A. Applicants for a mortuary transport service permit; B. Applicants for registration as a transporter for a mortuary transport service; C. Permitted mortuary transport services; and D. Registered transporters. #### Regulation .02 Definitions. *COMAR 10.29.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Morticians and Funeral Directors. (2) “CJIS” means the Criminal Justice Information System. (3) “Cleaning” means to disinfect the entire interior of the mortuary transport service vehicle, including the drivers’ cabin. (4) “Crematory” means a building, portion of a building, or structure that houses the necessary appliances and facilities for cremation. (5) “Criminal history records check” means the performance of both a: (a) State criminal history check by the Central Repository; and (b) National criminal history check by the Federal Bureau of Investigation. (6) “Disinfect” means a process that eliminates many or all pathogenic microorganisms, except bacterial spores, on inanimate objects using liquid chemicals or wet pasteurization. (7) “Funeral establishment” means any building, structure, or premises from which the business of practicing mortuary science is conducted. (8) Human Remains. (a) “Human remains” means: (i) The body of a deceased person; or (ii) A part of a body or limb that has been removed from a living person. (b) “Human remains” includes the body or part of a body or limb in any state of decomposition. (9) “Impervious surface” means a surface constructed from material that does not allow another substance to pass through or to penetrate the material. (10) “Licensed funeral establishment” means, unless the context requires otherwise, a funeral establishment that is licensed by the Board. (11) Mortuary Transport Service. (a) “Mortuary transport service” means an individual or a business entity issued a permit by the Board that, for compensation: (i) Removes and transports human remains; (ii) Transports human remains from the place of death or storage to a funeral establishment or crematory; or (iii) Employs a transporter to remove or transport human remains. (b) “Mortuary transport service” does not include: (i) A licensed funeral establishment using the establishment's own employee or employees to remove and transport human remains for compensation in the establishment's own Board-inspected vehicle; or (ii) A cemetery or an employee of a cemetery that removes or transports human remains within the boundaries of the cemetery. (12) “Office” means the Office of Cemetery Oversight within the Maryland Department of Labor. (13) “Permit” means a permit issued by the Board to the owner of a mortuary transport service to operate in the State. (14) “Permit holder” means a mortuary transport service that holds a permit issued by the Board. (15) “Registered transporter” means an individual employee of a mortuary transport service who has registered with the Board to remove and transport human remains. (16) “Registration” means a registration issued by the Board to a registered transporter to remove and transport human remains. (17) “Removal vehicle” means a vehicle of a size, dimensions, and specifications suitable for the transportation of human remains which has passed an inspection by the Board. (18) “Remove and transport human remains” means to remove human remains from one location and transport the human remains directly to another location. #### Regulation .03 Requirements for a Permit. *COMAR 10.29.21.03* A. To qualify for a permit to operate a mortuary transport service, an individual shall: (1) Be at least 18 years of age; (2) Be of good moral character; and (3) Satisfy the requirements of Health Occupations Article, §7-602(c), Annotated Code of Maryland. B. To apply for a permit, an individual shall submit to the Board: (1) An application signed by an individual who is the owner or co-owner of the mortuary transport service to be permitted on a form provided by the Board; (2) The required fee as set forth in Regulation .08 of this chapter; (3) A notarized statement attesting to compliance with Health Occupations Article, §7-602(c), Annotated Code of Maryland; (4) Evidence that all removal vehicles have passed an inspection by an inspector designated by the Board; and (5) Evidence that the mortuary transport service is bondable and carries liability insurance to cover each registered transporter employed by the mortuary transport service. C. A individual may not operate a mortuary transport service in the State without a permit issued by the Board. D. If the permit holder is the sole employee of the mortuary transport service, the permit holder shall also be registered as a transporter. E. The permit holder shall return an expired permit to the Board as soon as possible. F. The permit holder shall be responsible for registering all transporters in their employ. #### Regulation .04 Requirements for Registration. *COMAR 10.29.21.04* A. To qualify as a registered transporter, an individual shall: (1) Be at least 18 years of age; (2) Be of good moral character; (3) Hold a current valid driver’s license in good standing; and (4) Be employed by a mortuary transport service that holds a permit issued by the Board. B. Required Coursework. Before registering as a registered transporter, an individual shall complete the following Board approved coursework options: (1) An OSHA or MOSHA training course; (2) A course on blood-borne pathogens; (3) A course on infection control; and (4) A law course on: (a) Health-General Article, §5-513, Annotated Code of Maryland, excluding references to inspections of an out-of-State facility, with the objective of understanding the proper treatment of remains with dignity; and (b) This chapter. C. To apply for a registration as a registered transporter, an individual shall submit: (1) A signed application on a form provided by the Board; (2) Written, verified evidence satisfactory to the Board that the applicant has: (a) Completed the application for a criminal history records check using the process required by CJIS and designating that the check be sent to the Board; and (b) Paid all fees required by CJIS; (3) Evidence of successful completion of the coursework required by §B of this regulation; and (4) A copy of the individual's driving record, including probation before judgment findings. D. A registered transporter shall maintain a current mailing address, excluding a post office box address, on file with the Board. E. The permit of the mortuary transport service that employs the registered transporter shall be prominently displayed on the person of the registered transporter by means of an identification card. The identification card shall include the following information: (1) A current picture of the registered transporter; (2) The name of the mortuary transport service that employs the registered transporter; and (3) The permit number of the mortuary transport service. F. The permit holder shall confiscate the identification card of a transporter who is no longer in the permit holder’s employ and return the identification card to the Board. G. The Board may not register an applicant until the Board has: (1) Received and reviewed the criminal history records information; and (2) Approved the completed application. #### Regulation .05 Procedures. *COMAR 10.29.21.05* A. Before using a body bag for removal of human remains, the registered transporter shall inspect the body bag to ensure that the body bag is fully closeable and that there are no holes, rips, or tears in the body bag. B. Potentially Infectious Body Fluids. (1) All bodily fluids shall be considered as potentially infectious and dealt with appropriately. (2) Proper personal protective equipment shall be available for use at all times. (3) Contaminated surfaces and equipment shall be cleaned with disinfectant immediately upon completion of the removal or as soon as possible after the removal. C. After each removal and as soon as possible, the registered transporter shall clean their hands using antiseptic hand cleanser and paper towels or antiseptic towelettes. As soon as possible thereafter, the registered transporter shall wash their hands using hot running water and soap. D. The permit holder shall establish a written schedule for thorough cleaning, to be kept in the glove box of the removal vehicle, and method for cleaning the removal vehicle and equipment at least quarterly or as needed taking into account the use of the vehicle, the type of contamination present, and the human remains transferred. E. An individual authorizing removal shall be given an inventory in which the transporter has made note of all valuables found on the decedent for the individual’s signature. #### Regulation .06 Prohibited Acts. *COMAR 10.29.21.06* A. A permit holder or transporter shall: (1) At all times treat the human remains being transported with the utmost dignity; and (2) Comply with the requirements of Health-General Article, §5-513, Annotated Code of Maryland, except with regard to inspection of an out-of-State facility. B. A permit holder may not: (1) Violate any federal, State, or local law or regulation or order a transporter to violate any federal, State, or local law or regulation; (2) Employ a transporter who does not hold a registration issued by the Board; (3) In signage or advertisement, use a name for the mortuary transport service that is different from the name of the mortuary transport service as it appears on the permit issued by the Board; (4) Operate the mortuary transport service in a manner that does not respect: (a) The dignity of the decedent; and (b) The public health; (5) Prevent or in any way inhibit the Board’s designated inspector from investigating a complaint or from inspecting a removal vehicle; (6) Unless appropriately licensed, represent themselves as a mortician or funeral director; (7) Make arrangements for burial or cremation of human remains; (8) Fail to notify the Board within 30 days of: (a) A change in address of the mortuary transport service; (b) A change in address of a registered transporter; or (c) A commencement of employment or a separation of employment with a registered transporter; (9) Dress or behave in an unprofessional manner while performing their official duties; (10) Advertise or solicit business directly to the family of a dying person or recently deceased person; or (11) Offer goods or services other than the service a permit authorizes the permit holder to provide. C. A registered transporter may not: (1) Transport human remains without the required documented authorization; (2) Unless appropriately credentialed, represent themselves as a: (a) Permit holder; (b) Mortician; or (c) Funeral director; (3) Allow an individual who is not an employee of the employing mortuary transport service or of the funeral establishment engaging the services of the mortuary transport service to accompany the registered transporter while in the performance of the registered transporter’s official duties; (4) Make arrangements for burial or cremation of the human remains unless appropriately licensed or certified by the Board or the Office; (5) Unless removing and transporting more than one human remains from different locations, fail to transport the human remains directly to the location agreed upon by the individual with the right to final disposition of the human remains or to the location requested by the mortician or funeral director; (6) Fail to notify the Board of a change of the registered transporter’s address within 30 days; (7) Fail to display prominently on their person, in accordance with Regulation .04E of this chapter, the permit number of the mortuary transport service for which the registered transporter is employed; (8) Dress or behave in an unprofessional manner while performing their official duties. (9) Display in any removal vehicle any marking, sticker, or other indication of passage of a Board inspection other than the sticker issued by the Board; (10) Advertise or solicit business directly to the family of a dying person or recently deceased person; (11) Offer goods or services other than the service a permit authorizes the permit holder to provide; (12) Sign a death certificate; (13) Upon arrival at a location for the purpose of removing and transporting human remains, fail to: (a) Verbally identify themselves as a registered transporter; and (b) Identify the entity for whom they are removing and transporting human remains; (14) Perform their official duties in an unsanitary manner or in a manner that does not observe the Centers for Disease Control’s Guidelines on Universal Precautions; or (15) Eat, drink, or smoke in the removal vehicle while in the performance of their official duties. #### Regulation .07 Vehicle Standards. *COMAR 10.29.21.07* A. A removal vehicle shall: (1) Be of appropriate size for the transport of human remains; (2) Have windows tinted to the extent that human remains are obscured from public view; (3) Have a cargo bay which: (a) Is fully enclosed; and (b) Is designed to prevent co-mingling or shifting of human remains while in transit; and (4) Have a floor which is a nonporous, impervious surface. B. A removal vehicle shall include at least the following equipment: (1) A removal stretcher and litter, each with a leakproof pouch; and (2) A universal precaution kit which shall include the following: (a) A red bio-waste bag; (b) A heavy disaster pouch; (c) Goggles; (d) Booties; (e) A mask; (f) Disposable gloves; (g) A clean or disposable apron; (h) Antiseptic hand cleaner; (i) Disinfectant spray; (j) Clean towels; and (k) A first-aid kit. C. Before the sale of a removal vehicle, the permit holder shall have the vehicle disinfected. D. Removal vehicles shall be inspected by a Board designated inspector at least every 2 years starting from the date of first inspection. E. A removal vehicle which has passed a Board inspection shall prominently display a Board-issued sticker on the vehicle attesting to passage of the inspection. #### Regulation .08 Fees. *COMAR 10.29.21.08* The following fees related to mortuary transport services are established by the Board: A. Mortuary Transport Service Permit: (1) Initial fee: (a) Category 1 (for 1 — 3 transporters, including the permit holder) — $350; (b) Category 2 (for 4 — 7 transporters, including the permit holder) — $500; (c) Category 3 (for 8 — 15 transporters, including the permit holder) — $750; and (d) Category 4 (for more than 15 transporters, including the permit holder) — $1,000; and (2) Renewal fee: (a) The permit renewal fee shall be the same as the initial fee provided there has been no change in category; (b) If the number of transporters employed by a mortuary transport service has increased, resulting in a change in category, the initial fee for the higher category shall be paid as the renewal fee; and (c) If the number of transporters employed by a mortuary transport service has decreased, resulting in a change in category, the initial fee for the lower category shall be paid as the renewal fee; B. Transporter registration processing fee (to add a transporter without change of category within the renewal cycle) — $40; C. Late fee (permit) — $400; D. Reinstatement fee — $350 + initial fee; E. Duplicate or replacement permit — $40; F. Duplicate registration — $50; G. Permit or registration verification fee — $40; and H. Replacement inspection sticker — $40. #### Regulation .09 Renewal Requirements. *COMAR 10.29.21.09* A. A mortuary transport service’s permit expires 30 days after the effective date of this chapter. B. After being issued an initial permit, a mortuary transport service’s permit: (1) Expires on the date set by the Board, unless it is renewed for an additional term; and (2) May not be renewed for a term longer than 2 years. C. At least 2 months before the permit expires, the Board shall issue a renewal notice to the permit holder that states: (1) The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the registration expires; and (2) The amount of the renewal fee. D. The permit holder may renew the mortuary transport service permit for an additional term of 2 years if the permit holder: (1) Is otherwise entitled to be issued a permit; (2) Pays to the Board a renewal fee set forth in Regulation .08 of this chapter; and (3) Submits to the Board: (a) A completed renewal application on the form that the Board requires; (b) An updated criminal history records check; and (c) An updated driving record, including probation before judgment findings. E. The Board shall impose the late fee established in Regulation .08 of this chapter on any permit holder who fails to renew their permit 1 month before it expires. F. A transporter’s registration is effective provided: (1) It has not been suspended or revoked by the Board; and (2) The registered transporter is employed by a mortuary transport service which holds a permit issued by the Board. #### Regulation .10 Reinstatement Requirements. *COMAR 10.29.21.10* A. To reinstate an expired permit, an individual shall: (1) Resubmit the application required by the Board for initial applicants; (2) Satisfy the education requirements stated in Regulation .04B of this chapter; and (3) Pay to the Board the reinstatement fee established by the Board in Regulation .08 of this chapter. B. An individual whose registration has lapsed shall reapply to the Board under the procedure set forth in Regulation .04 of this chapter. #### Regulation .11 Multi-State Establishments. *COMAR 10.29.21.11* All vehicles registered by an establishment which is part of the same business structure as a licensed Maryland funeral establishment shall be inspected by the Board at a convenient location within the State if the related establishment intends to transport Maryland decedents in their vehicles. ### Chapter 22 — General Regulations **Authority:** Health-General Article, §5-513; Health Occupations Article, §7-205, Annotated Code of Maryland **Administrative History:** Effective date: August 5, 2013 (40:15 Md. R. 1229) **Administrative History:** Regulation .01 amended effective May 11, 2026 (53:9 Md. R. 413) #### Regulation .01 Temperature of Refrigeration Units. *COMAR 10.29.22.01* A refrigeration unit used in the storage of human remains shall be kept at a temperature lower than 40 degrees Fahrenheit. ## Subtitle 30 — Maryland Commission on Kidney Disease ### Chapter 01 — General Regulations **Authority:** Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1972 **Administrative History:** Regulations .01 — .09 repealed and new regulations .01 — .09 adopted effective July 19, 1982 (9:14 Md. R. 1431) **Administrative History:** Regulations .04, .05, and .07L amended effective August 1, 1983 (10:15 Md. R. 1350) **Administrative History:** Regulation .07B amended effective February 27, 1984 (11:4 Md. R. 314); August 20, 1987 (14:16 Md. R. 1775); November 16, 1987 (14:23 Md. R. 2414) **Administrative History:** Regulation .07B and Q amended as an emergency provision effective January 1, 1987 (14:6 Md. R. 711, 14:9 Md. R. 1077); emergency status expired August 20, 1987 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .07Q amended effective July 2, 1984 (11:13 Md. R. 1777); August 20, 1987 (14:16 Md. R. 1775) **Administrative History:** Regulation .07Q amended as an emergency provision effective July 2, 1984 (11:15 Md. R. 1327); adopted permanently effective December 19, 1984 (11:23 Md. R. 1992) **Administrative History:** Regulation .07R adopted effective August 1, 1983 (10:15 Md. R. 1350) **Administrative History:** Regulation .07S adopted as an emergency provision effective September 14, 1983 (10:20 Md. R. 1781); emergency status expired January 31, 1984 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .10 adopted effective December 20, 1982 (9:25 Md. R. 2484) **Administrative History:** Regulations .11 and .13 adopted effective August 1, 1983 (10:15 Md. R. 1350) **Administrative History:** Regulation .11 amended effective November 3, 1986 (13:22 Md. R. 2399) **Administrative History:** Regulation .12 adopted effective June 4, 1984 (11:11 Md. R. 962) **Administrative History:** Chapter revised effective October 31, 1988 (15:22 Md. R. 2556) **Administrative History:** Regulation .04A amended effective April 15, 1991 (18:7 Md. R. 773); May 20, 1996 (23:10 Md. R. 732) **Administrative History:** Regulation .04C adopted effective May 20, 1996 (23:10 Md. R. 732) **Administrative History:** Regulation .05 amended effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .06F amended effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .07 repealed and new Regulation .07 adopted effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .07A and M amended effective April 15, 1991 (18:7 Md. R. 773) **Administrative History:** Regulation .11C amended effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .14 amended effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulation .15 adopted as an emergency provision effective July 1, 1992 (19:13 Md. R. 1200); emergency status expired November 8, 1992 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .15 adopted effective May 9, 1994 (21:9 Md. R. 751) **Administrative History:** Regulation .15 repealed and new Regulation .15 adopted effective October 24, 1994 (21:21 Md. R. 1814) **Administrative History:** Regulation .15F repealed effective August 23, 1999 (26:17 Md. R. 1323) **Administrative History:** Regulation .16 adopted effective December 19, 1994 (21:25 Md. R. 2105) **Administrative History:** Regulations .01 — .16 repealed and new Regulations .01 — .11 adopted effective December 22, 2003 (30:25 Md. R. 1846) **Administrative History:** Regulation .02B amended effective April 5, 2010 (37:7 Md. R. 571); March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .02-1 adopted effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .03G adopted effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .08B amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .10A amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .11C adopted effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Chapter revised effective August 18, 2025 (52:16 Md. R. 846) #### Regulation .01 Purpose. *COMAR 10.30.01.01* In recognition of its continuing responsibility to its citizens to aid in reduction of the personal financial hardships associated with end-stage kidney disease, the State continues its commitment of resources to the Kidney Disease Program of Maryland. This subtitle is designed so that Maryland may provide help and support for its citizens whose needs are partially or wholly unmet by present federal or private support, or both, for end stage kidney disease. #### Regulation .02 Definitions. *COMAR 10.30.01.02* A. In this subtitle, the following terms have the meanings indicated. B. Terms Defined. (1) “Abusive and dangerous patient” means a patient who is physically or verbally threatening to the patient's person, facility staff, or other patients. (2) “Acute dialysis” means dialysis employed in the treatment of temporary kidney failure, with the expectation that dialysis may be necessary for 4 weeks or less because recovery of kidney function is anticipated. (3) “Administrator” means an individual appointed by the governing body who is responsible for the facility's daily operations and the duties set forth in COMAR 10.30.02.03F. (4) “Certified nursing assistant—dialysis technician” means an individual licensed by the Maryland Board of Nursing to perform nursing tasks delegated by a licensed nurse in the dialysis facility. (5) “Certified patient” means a patient who is certified by the Commission on Kidney Disease and is eligible for benefits from the Kidney Disease Program. (6) “Chief executive officer” means an individual who meets the requirements set forth in 42 CFR §494.180, which is incorporated by reference; (7) “Chronic dialysis” means dialysis employed to compensate for the severe and irreversible loss of kidney function and is a permanent treatment modality unless replaced by kidney transplantation. (8) “Chronic peritoneal dialysis” means dialysis performed repetitively by exchanging large volumes of solution within the peritoneal cavity. (9) “Commission” means the Commission on Kidney Disease. (10) “Department” means the Maryland Department of Health. (11) Dialysis. (a) “Dialysis” means the process of filtering waste products and excess fluid from the blood of a patient with severely compromised kidney function. (b) “Dialysis” includes the terms hemodialysis and peritoneal dialysis. (12) “Governing body” means an identifiable individual or individuals who are designated in writing with full legal authority and responsibility for the governance and operation of the facility. (13) “Home dialysis” means chronic hemodialysis or chronic peritoneal dialysis performed regularly in the home by the patient and an assistant, if necessary. (14) “Home training dialysis” means: (a) Chronic peritoneal dialysis, including continuous ambulatory peritoneal dialysis and continuous cycling peritoneal dialysis; or (b) Instructional chronic hemodialysis. (15) “In-center hemodialysis” means a hemodialysis treatment that: (a) Lasts 3 to 5 hours; (b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and (c) Is provided in a kidney dialysis facility. (16) “In-center nocturnal hemodialysis” means a hemodialysis treatment that: (a) Lasts 6 to 9 hours; (b) Is performed on a routine basis, usually three times a week, to treat a chronic condition; and (c) Is provided in a kidney dialysis facility. (17) “Monitoring individual” means an individual who is a direct patient care provider. (18) “Nurse manager” means an individual who is responsible for nursing services and provides oversight and direction to all direct care staff that provide dialysis and nursing care in a kidney dialysis facility. #### Regulation .02-1 Incorporation by Reference. *COMAR 10.30.01.02-1* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) 42 CFR §§494.1 — 494.110, as amended; and (2) 42 CFR §§494.130 — 494.180, as amended. #### Regulation .03 Categories of Dialysis. *COMAR 10.30.01.03* A. The categories of dialysis listed in §§BF of this regulation are recognized on the basis of differing facility requirements. B. Acute Dialysis. Acute dialysis is not reimbursable under the Kidney Disease Program and nothing in this subtitle is meant to refer to acute dialysis. C. Chronic Dialysis. (1) Chronic dialysis may be provided in the dialysis facilities defined and described in this subtitle. (2) Chronic dialysis may be preceded by adequate studies to confirm that the kidney failure is irreversible. D. Home Dialysis. A period of training in an approved home dialysis training facility is required before a patient can safely undergo dialysis treatments in the home. E. Home Training Dialysis. (1) Home training dialysis is usually conducted in a center with simultaneous dialysis and instruction provided to the patient that includes the technique of performing the type of dialysis selected. (2) The period required for this training differs depending on the individual circumstances, and requires the expertise and equipment necessary for providing adequate home training. (3) A responsible third party may be included in the training. F. Chronic Peritoneal Dialysis. (1) This process can substitute for kidney function that has been permanently lost and represents a permanent treatment unless replaced by either hemodialysis or kidney transplantation. (2) Long-term care of end-stage kidney disease by chronic peritoneal dialysis may be carried out either in a dialysis facility or in the home. G. Nocturnal Hemodialysis. Nocturnal hemodialysis may be provided in the dialysis facilities defined and described in this subtitle. #### Regulation .04 Classifications of Facilities. *COMAR 10.30.01.04* A. Kidney Transplant Center. (1) A kidney transplant center shall be a physically discrete unit or division within a hospital approved by the Joint Commission on Accreditation of Healthcare Organizations having the staff and facilities capable of evaluating potential candidates for kidney transplantation. (2) Transplantation Service. The transplantation division may be administratively and physically separate from the dialysis division, but shall work in close cooperation with an associated dialysis program. B. Freestanding Dialysis Facility. The freestanding dialysis facility's functions include: (1) A dialysis facility capable of providing chronic staff-assisted dialysis which may be performed in a freestanding dialysis facility or in an end-stage kidney disease certified hospital-based unit; (2) Referrals provided for operative, X-ray, and laboratory services under arrangement; (3) Affiliation with a certified dialysis facility for backup purposes; and (4) Affiliation with a certified transplant center. C. Home Dialysis Programs. A home dialysis program's functions include a dialysis facility specifically designed and staffed to train patients and patients' helpers to perform dialysis at home. #### Regulation .05 Patient Standards. *COMAR 10.30.01.05* A. General Considerations. (1) Patients who are accepted for dialysis and kidney transplantation: (a) Shall be accepted on medical grounds alone; (b) May not be accepted based on age, race, sex, social background, national origin, religion, or financial resources; and (c) Are the responsibility of the dialysis or transplant centers, or both, but shall conform to the medical guidelines established in §B of this regulation. (2) The Kidney Disease Program is financially responsible only for residents of the State who are certified as eligible for participation in the Kidney Disease Program. (3) Maryland residents treated in dialysis facilities or transplant centers outside the State are not eligible for reimbursement unless the treatment has been preauthorized by the Commission. (4) The Commission may authorize a treatment for documented reasons of continuity of care, or geographical proximity of the patient's residence to the dialysis facility or transplant center, or both. (5) Except as provided in §C of this regulation, if a patient is accepted by a facility for dialysis, transplantation, or both, the patient is the responsibility of that facility and the facility's staff until that responsibility is terminated by mutual agreement between the facility and patient. (6) The Commission shall review each facility's policy regarding discharge of patients from the facility's program. (7) Any separation that is not mutually accepted shall be documented in writing by the facility and reviewed by the Commission to determine whether there has been a violation of laws or regulations of the State. B. Medical Guidelines. A patient may be accepted for treatment if the patient meets any of the following criteria: (1) Has end-stage kidney disease requiring kidney replacement therapy to sustain life; (2) A patient who grants informed consent and who has had a thorough medical, psychosocial evaluation indicating a reasonable expectation of benefiting from either chronic dialysis or transplantation; (3) Has chronic end-stage kidney disease and is a qualified resident of this State, except when documented medical reasons contraindicate dialysis; or (4) Has rejected a transplanted kidney making the patient immediately eligible for consideration for readmission into a chronic dialysis program if the patient is a medically suitable candidate. C. Abusive and Dangerous Patients. (1) A facility shall: (a) Develop policies for the management of abusive and dangerous patients; (b) Maintain these policies in the policy and procedures manual in the dialysis facility; and (c) Inform the patient in writing of the facility's policy for the management of abusive and dangerous patients. (2) A separation or discharge may be implemented by the facility only after the patient has been given written notice by the facility and has had a reasonable opportunity to terminate the abusive and dangerous behavior, however: (a) A patient who commits violence in a facility may be discharged; and (b) The Commission shall require documentation of the violence to support a discharge. (3) The Commission shall review each facility's policy for the management of abusive and dangerous patients and the facility's method of implementation of this policy during the Commission's survey. D. Complaints. (1) The Commission shall investigate complaints received from patients, providers, anonymous persons, and other interested parties including family members. (2) The Commission shall consider all complaints submitted to the Commission office for further investigation. #### Regulation .06 Reimbursement Principles. *COMAR 10.30.01.06* A certified facility and recipient shall comply with COMAR 10.20.01 and with the requirements of this chapter to be eligible for reimbursement. #### Regulation .07 Procedures for Certification of Facilities. *COMAR 10.30.01.07* A. Providers or consumers of medical care contemplating development of a transplant center or a dialysis facility shall notify the Commission within 30 days of applying for licensure or certification with the Office of Health Care Quality of the Department. B. The Department or the Commission, or both, shall: (1) Review the facility application; (2) Survey for compliance with this subtitle; and (3) Certify the facility’s existing Office of Health Care Quality license. C. The Commission, through the Department, shall certify the dialysis facilities and transplant centers once the standards have been met as set forth in this subtitle. D. Certified patients are eligible for reimbursement of medical care only after a dialysis facility or transplant center has received Kidney Disease Program certification. E. Programs denied certification on the basis of a failure to meet the Commission's standards may file an appeal with the Commission for a specific interpretation of the standards applicable in that individual case. #### Regulation .08 Affiliation Guidelines. *COMAR 10.30.01.08* A. To assure quality and continuity of patient care, formal affiliation agreements shall be negotiated as required in the standards and guidelines of the Commission. The affiliation agreement shall be constructed so no entity benefits financially. B. Affiliation agreements shall include, but not necessarily be limited to, the: (1) Means by which patients may be transferred between the affiliated institutions for the purpose of providing dialysis, transplantation services, or other medical care; (2) Conditions under which dialysis facilities, hospitals, and transplant centers agree to provide medical backup facility to assure optimal patient care; (3) Mechanisms for assuring quality of care including provisions for consultative help and review of patient progress; (4) Provisions of or referral to a certified home dialysis training program with specific mechanisms for ensuring adequate supervision and assistance for patients on home dialysis; and (5) Specific provisions by hospitals to end-stage kidney disease patients for dialysis services as well as adequate: (a) Laboratory services; (b) Social services; and (c) Dietetic services; C. The dialysis facility shall review and revise the affiliation agreements periodically and if a change in ownership or other details of operation changes during the period while the affiliation agreement is in force. #### Regulation .09 Residency Requirements. *COMAR 10.30.01.09* To be eligible for the Kidney Disease Program, an individual shall be one of the following: A. A citizen of the United States residing in Maryland; or B. An alien lawfully admitted for permanent residence or otherwise permanently residing in the United States under color of law, including an alien who is lawfully present in the United States pursuant to 8 U.S.C. §1101 et seq. and who is residing in Maryland. #### Regulation .10 Certification and Revocation. *COMAR 10.30.01.10* A. Certification. (1) The Commission, through the Department, shall certify a facility or center to perform dialysis upon determination that the facility or center meets the standards adopted by the Commission, including: (a) 42 CFR §§494.1 — 494.110, as amended; and (b) 42 CFR §§494.130 — 494.180, as amended. (2) The certification of the facility or center shall continue in effect unless suspended or revoked by the Secretary as recommended by the Commission. B. Revocation of Certification or Suspension of Payments. (1) The Secretary shall delegate to the Commission the performance of periodic surveys of dialysis facilities or transplant centers. (2) The Commission shall immediately report to the Secretary if patient safety and welfare are compromised at the facility. However, this reporting does not preclude the Commission from taking immediate independent corrective action. (3) The Commission may, by vote of the majority of the members in attendance, recommend to the Secretary to revoke or suspend payments to a dialysis facility or transplant center not in compliance with this subtitle. (4) Reimbursements may not be made during the term of the suspension or revocation. C. The Secretary may revoke the certification of a dialysis facility or transplant center to participate in the Kidney Disease Program at any time for failure to comply with this subtitle. D. The Commission may review any revocation or proposed revocation of certification and make an independent recommendation to the Secretary. E. In accordance with the Maryland Administrative Procedure Act, a person aggrieved by a decision of the Secretary is entitled to a hearing in accordance with COMAR 10.01.03. #### Regulation .11 Miscellaneous Items. *COMAR 10.30.01.11* A. A serious occurrence which threatens the safety and health of the patients shall be reported immediately by a facility to the Commission, local health department, and the Office of Health Care Quality of the Department. B. In the event of a natural disaster or other imminent threat to the safety or health of a group of dialysis patients, the Secretary may immediately authorize, with timely notification of all involved professional personnel and patients, the: (1) Relocation of an existing dialysis facility or center; and (2) Transfer of dialysis patients in accordance with medical needs. C. Emergency Management. (1) A kidney dialysis facility shall have an emergency plan. (2) An emergency plan shall include policies and procedures that will be followed before, during, and after an emergency to address: (a) The safe management of individuals who are receiving services at the kidney dialysis facility when an emergency occurs; (b) Notification of patients, families, staff, and licensing authorities regarding actions that will be taken concerning the provision of dialysis services to the individuals served by the kidney dialysis facility; (c) Staff coverage, organization, and assignment of responsibilities; and (d) The continuity of operations, including procedures to secure access to essential goods, equipment, and dialysis services. (3) This regulation does not prohibit a kidney dialysis facility from applying for and receiving reimbursement: (a) Under any applicable insurance policy; or (b) From any State or federal funds that may be available due to a declared State or federal emergency. (4) A kidney dialysis facility is solely responsible for any financial obligation arising from voluntary or mandatory activation of any aspect of the emergency plan developed by the kidney dialysis center under this regulation. (5) For purposes of coordinating local emergency planning efforts, a kidney dialysis facility shall provide access to the emergency plan developed under this regulation to local organizations for emergency management. (6) A dialysis provider shall provide to the Commission a 24/7 live operational contact phone number. (7) Information Regarding the Status of Generators. A kidney dialysis facility shall have: (a) An on-site generator; (b) The capacity to hook up a generator; or (c) A contract with a company who will provide a generator in the event of an emergency, if there is no on-site generator. (8) If the center has no plan to use the services of a generator, the center shall provide to the Commission a copy of the center's emergency plan that will demonstrate that all measures possible are in place to avoid disruption of dialysis services to patients. ### Chapter 02 — Physical and Medical Standards **Authority:** Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland **Administrative History:** Effective date: December 22, 2003 (30:25 Md. R. 1846) **Administrative History:** Regulation .01 repealed effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .02 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .04 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .04C amended effective April 24, 2006 (33:8 Md. R. 733) **Administrative History:** Regulation .04G adopted effective April 24, 2006 (33:8 Md. R. 733) **Administrative History:** Regulation .05C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .06C amended effective April 24, 2006 (33:8 Md. R. 733); April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Chapter revised effective March 16, 2015 (42:5 Md. R. 486) **Administrative History:** Regulation .02 amended effective August 18, 2025 (52:16 Md. R 846) **Administrative History:** Regulation .03 amended effective August 18, 2025 (52:16 Md. R 846) **Administrative History:** Regulation .04 amended effective August 18, 2025 (52:16 Md. R 846) **Administrative History:** Regulation .05A, B, H amended effective August 18, 2025 (52:16 Md. R 846) **Administrative History:** Regulation .06A, C, E amended effective August 18, 2025 (52:16 Md. R 846) **Administrative History:** Regulation .07 amended effective August 18, 2025 (52:16 Md. R 846) #### Regulation .01 Repealed. *COMAR 10.30.02.01* #### Regulation .02 Transplant Centers. *COMAR 10.30.02.02* A. Location and Program Affiliation. (1) Centers seeking certification as transplant centers, under Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall be located in hospitals that are accredited by the Joint Commission on Accreditation of Healthcare Organizations and participate in a patient registry program with a certified organ procurement organization. (2) An agreement shall exist with an established functioning tissue typing laboratory providing 24-hour-a-day service. (3) The hospital shall provide an active nephrology service to provide for continuity of care. (4) The transplantation program shall conform to generally accepted medical standards for tissue typing and for transplantation. (5) For the purpose of protecting patient safety and welfare, a transplant center may not discontinue or phase out patient services until: (a) The transplant center has notified the Commission of the transplant center's intention; (b) Patients being treated by that transplant center have been transferred to another transplant center; (c) Patients' continuing care has been assured to the satisfaction of the patient and the Commission; (d) The transplant center submits to the Commission evidence that the transfer of patients to another transplant center has been satisfactorily accomplished; and (e) Patients being treated in a transplant center that is withdrawing from the Kidney Disease Program are provided continued access to the same reimbursement principles of the Kidney Disease Program. B. Physical Standards. The transplant center shall be located in a hospital that is participating as a provider of services in the Medicare program and is approved by Centers for Medicare and Medicaid Services as a kidney transplantation center. C. Staffing. (1) Director of Transplantation Center. The kidney transplantation center shall be under the general supervision of: (a) A UNOS qualified transplantation surgeon (42 CFR §405.2102) and a qualified transplant nephrology physician director; or (b) Another physician meeting UNOS criteria as a physician director for kidney transplantation (42 CFR §405.2102). (2) The director shall be responsible for planning, organizing, conducting and directing the transplant center and devoting sufficient time to carry out these responsibilities, which include but are not limited to: (a) Coordinating with the hospital in which the transplant center is located to ensure adequate training of nursing staff and clinical transplant coordinators in the care of transplant patients and living donors; (b) Ensuring that tissue typing and organ procurement services are available through a UNOS associated OPO and an ASHI certified laboratory; (c) Ensuring that transplantation surgery is performed by, or under the direct supervision of, a UNOS qualified transplant surgeon; and (d) Ensuring that the transplant center shall have an adequate number of clinical transplant coordinators to ensure the continuity of care of patients and living donors during the: (i) Pre-transplant, transplant, and discharge phases of transplant; and (ii) Donor evaluation, donation, and discharge phases of donation. (3) The clinical transplant coordinator shall: (a) Be a registered nurse or clinician licensed by the state in which the clinical transplant coordinator practices; and (b) Have experience and knowledge of transplantation and living donation issues. (4) The clinical transplant coordinator's responsibilities include, but are not limited to: (a) Ensuring the coordination of the clinical aspects of transplant patient and living donor care; and (b) Acting as a liaison between kidney transplant centers and dialysis facilities. (5) The transplant center that performs living donor transplantation shall identify either an independent living donor advocate or an independent living donor advocate team to ensure the protection of the rights of living donors and prospective living donors. (6) The living donor advocate or living donor advocate team may not be involved in transplantation activities on a routine basis. (7) The kidney transplant center shall: (a) Directly furnish transplantation and other medical and surgical specialty services required for the care of ESRD patients; and (b) Have written policies and procedures for ongoing communications with the dialysis patients' local dialysis facilities. D. Additional Transplant Program Requirements. (1) Sufficient skilled personnel shall be available to provide 24-hour-a-day coverage for the transplantation service. (2) A transplantation team shall exist in a certified transplant center consisting of: (a) The transplant center director; (b) The director's assistant; and (c) A UNOS certified transplant surgeon, if not the transplant center director, and a UNOS certified physician director (a transplant nephrologist or physician meeting UNOS criteria to be a physician director for a kidney transplant program). E. Physical and Medical Standards. The transplant center shall: (1) Provide support services in clinical immunology, infectious diseases, and immunopathology; and (2) Be an administratively separate and distinct division or unit. F. Transplant Activity. (1) For optimum performance and success of the transplant procedure, transplant centers shall perform a minimum of 10 transplants per year. (2) The Commission recognizes that the number of transplants performed depends on many variables and the standard specified in §F(1) of this regulation serves only as a guideline. (3) The guideline specified in §F(1) of this regulation is established to indicate that transplant centers shall remain active in order to improve the success rate and to lower costs. G. The transplant center shall make arrangements for medical records, patient care policies, dietetic services, sanitation standards, and fire and life safety standards as referenced in this subtitle. H. Patient Treatment Eligibility. (1) In general, the patient eligibility standards as established for the dialysis program shall apply to the transplantation program, recognizing that constant improvements in the immunology and treatment of the rejection process are increasing the number of disease processes in which transplantation is applicable. (2) Written recommendations about the mode of therapy shall be kept on file for the review of the Commission. (3) Since transplantation is at present the best means of treating most patients with irreversible kidney failure, transplantation shall be considered for all patients accepted into this program when reasonable benefit and success are anticipated. However, candidacy for transplantation may not be a basic criteria for eligibility into the overall Kidney Disease Program. (4) A patient rejecting a transplanted kidney shall automatically receive assistance to gain entry into a dialysis program. I. Administration. (1) The transplant center shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the transplant patients. (2) Before placement on the center's waiting list, a prospective transplant candidate shall: (a) Receive a psychosocial evaluation; and (b) Ensure that the candidate's medical record contains documentation that the candidate's blood type has been determined. (3) When a patient is placed on a center's waiting list or is selected to receive a transplant, the center shall document in the patient's medical record the patient's eligibility criteria used. (4) The transplant center shall provide a copy of its patient selection criteria to a transplant patient, or a dialysis facility, as requested by a patient or dialysis facility. (5) The transplant center shall have written patient management policies for the transplant and discharge phases of transplantation. If a transplant center performs living donor transplants, the center also shall have written donor management policies for the donor evaluation, donation, and discharge phases of living organ donation. (6) The transplant center's patient and donor management policies shall ensure that: (a) Each transplant patient is under the care of a multidisciplinary patient care team coordinated by a physician throughout the transplant and discharge phases of transplantation; and (b) If a center performs living donor transplants, each living donor is under the care of a multidisciplinary patient care team coordinated by a physician through the donor evaluation, donation, and discharge phases of donation. (7) A transplant center shall keep their waiting lists up to date on an ongoing basis including: (a) Updating of waiting list patients' clinical information; (b) Removing patients from the center's waiting list if a patient receives a transplant or dies, or if there is any other reason the patient should no longer be on a center's waiting list; (c) Notifying the Organ Procurement and Transplant Network not later than 24 hours after a patient's removal from the center's waiting list; and (d) Notifying the patient and dialysis facility if applicable if the patient is removed from the center's waiting list. (8) The transplant center shall develop guidelines to ensure adequate patient and freestanding dialysis facility notification of change in patient transplant status. (9) The transplant center shall maintain up-to-date patient management records for each patient who receives an evaluation for placement on a center's waiting list and who is admitted for organ transplantation. (10) The transplant center shall make social services available, furnished by qualified social workers, to transplant patients, living donors, and their families. (11) The transplant center shall develop, implement, and maintain a written comprehensive data driven Quality Assessment and Performance Improvement (QAPI) program designed to monitor and evaluate performance of all transplantation services. The QAPI program shall include, but not be limited to: (a) Patient and donor eligibility criteria; (b) Accuracy of the waiting list; (c) Assurance of donor and recipient matching; (d) Patient and donor management; (e) Consent practices; (f) Patient education; (g) Patient satisfaction; and (h) Patient rights. (12) The transplant center shall take actions that result in performance improvements and track performance to ensure that improvements are sustained. (13) The transplant center shall establish and implement written policies to address and document adverse events that occur during any phase of an organ transplantation case. (14) The hospital shall provide designated administrative personnel to keep the necessary records as well as other information needed for accurate determination of cost. (15) The hospital or transplant center administration shall assure that patients are informed of the center's internal and external grievance mechanisms. J. Compliance. Transplant centers shall comply with the provisions set forth in this subtitle. #### Regulation .03 Freestanding Dialysis Facilities — General. *COMAR 10.30.02.03* A. Location and Program Affiliation. (1) Freestanding dialysis facilities seeking a certification as a freestanding dialysis facility, under the terms of Health-General Article, Title 13, Subtitle 3, Annotated Code of Maryland, shall have, for the diagnosis and treatment of irreversible kidney failure and its complications, arrangements with: (a) A laboratory that meets the needs of end-stage kidney disease patients; (b) A hospital that can provide acute care services to meet the needs of end-stage kidney disease patients; (c) A backup dialysis facility; and (d) Transplant services. (2) A freestanding dialysis facility desiring to phase out or discontinue dialysis services shall notify the Commission as soon as the decision to withdraw the facility from the Kidney Disease Program has been made by the administration of the facility. (3) A freestanding dialysis facility withdrawal from the Kidney Disease Program may not be accomplished until: (a) Patients being treated by that freestanding dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patient and the Commission; (b) The freestanding dialysis facility has submitted to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and (c) Patients previously certified and being treated in a freestanding dialysis facility that is being withdrawn from the Kidney Disease Program have continued access to the same reimbursement principle of the Kidney Disease Program. B. Physical Standards. The freestanding dialysis facility shall: (1) Have usable floor space of at least 80 square feet per patient station that may include bed or chair space, nursing space, and work area but excludes storage space; (2) Have at least 20 square feet of the patient station floor space available on the side of the patient to be occupied by the dialysis assembly; (3) Arrange the space to be sufficiently flexible to provide access to any of the four extremities; (4) Contain a nursing station and be designed for patient privacy, surveillance, and isolation when indicated; (5) Provide refrigerated and nonrefrigerated storage space; (6) Provide sufficient area and space for: (a) Maintenance of equipment; (b) Storage of the equipment and supplies; and (c) Preparing and testing dialyzers; (7) Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation's recommendations which are incorporated by reference in this subtitle to prevent bacterial or endotoxin contamination or toxic accumulation of trace elements in patients undergoing long-term dialysis; (8) Comply with medical records, patient care policies, sanitation standards, and fire and life safety standards as set forth in this subtitle; and (9) Comply with the quality assurance program as identified in Regulation .04B(3)(s) of this chapter and provide: (a) Summarized format documentation, upon request, of the facility’s quality assurance program; and (b) Written documentation of the facility’s meeting attendance, goals, outcomes, and action plans, including evaluation and revision of the plans, as appropriate. C. Administration. (1) The freestanding dialysis facility shall be under the supervision of the governing body. The governing body shall: (a) Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and (b) Develop a written organizational plan. (2) The freestanding dialysis facility administration shall: (a) Be under the supervision of the governing body; and (b) Provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request. (3) The freestanding dialysis facility shall provide designated administrative personnel to keep necessary records as well as other information for accurate determination of costs. (4) The freestanding dialysis facility administration shall assure that patients are informed of the facility's internal and external grievance mechanisms. D. Compliance. Freestanding dialysis facilities shall comply with: (1) The provisions set forth in this subtitle; (2) Regulation .04 of this chapter; and (3) The requirements of this subtitle for certification purposes with the Commission. E. Governing Body. The governing body shall: (1) Identify the facility administrator who has been given the authority and responsibility for the overall policy and fiscal management of the facility; and (2) Develop a written organizational plan. F. Administrator. (1) Qualifications. (a) The kidney dialysis facility administrator, if not the chief executive officer, shall at a minimum: (i) Be 21 years old or older; (ii) Possess a high school diploma or a high school equivalency diploma and have experience to conduct the responsibilities specified in §B(2) of this regulation; (iii) Have at least 1 year of dialysis experience; and (iv) Have no criminal conviction or other criminal history that indicates behavior that is potentially harmful to patients, documented through a criminal history records check completed within 1 month before employment. (b) The administrator, if not the chief executive officer, shall have knowledge in: (i) Infection control; (ii) Principles of dialysis; (iii) Water treatment; (iv) Reuse; (v) Data collection and quality assurance; (vi) Emergency procedures; (vii) Fiscal operations, including business management and personnel; (viii) Regulations; and (ix) Policies and procedures. (2) Duties. (a) The administrator shall be on site or available on call. (b) The administrator shall have overall responsibility for: (i) Implementing the facility's policies and coordinating the provision of services that the facility provides; (ii) Organizing and coordinating the administrative functions of the facility; (iii) Establishing procedures for the accountability of those personnel involved in patient care; (iv) Familiarizing the staff with the facility's policies and procedures, and with applicable federal, State, and local laws and regulations; (v) Participating in the development, negotiation, and implementation of agreements or contracts into which the facility enters; (vi) Participating in the development of organizational and fiscal planning for the facility; (vii) Implementing and evaluating, under the direction of the clinical team, the patient care plan and the long-term care program for each patient; and (viii) Informing patients of the availability of emergency services. (3) Waiver of Requirements for Administrator. (a) The Commission may grant a kidney dialysis facility a waiver, with or without conditions, for a facility that operates an administrator-in-training program. (b) A facility with an administrator-in-training program shall submit to the Commission the: (i) Administrator-in-training curriculum, including course outline and supporting materials; (ii) Facility requirements for individuals who are eligible to participate in the administrator-in-training program; and (iii) Protocols in place that assure that the approval of the waiver will not adversely affect the quality of care received by patients. (c) In evaluating a waiver request submitted under this regulation, the Commission shall review the statements in the application and may: (i) Inspect the kidney dialysis center; or (ii) Confer with the governing body. (d) Grant or Denial of Waiver. The Commission may grant a waiver request if it determines that: (i) The administrator-in-training program sufficiently meets the requirements of this regulation; and (ii) A waiver will not adversely affect patients. (e) If the Commission determines that the conditions of §F(1) and (2) of this regulation are not met, the Commission shall deny the request for a waiver. The denial of a waiver may not be appealed. (f) Written Decision. (i) The Commission shall issue and mail to the licensee a final written decision regarding a waiver request submitted under this regulation within 45 days from receipt of the request. (ii) If the Commission grants a waiver, the written decision shall include the waiver's duration and any conditions imposed by the Department. (g) If a licensee violates any condition of the waiver, or if it appears to the Secretary that the health or safety of patients will be adversely affected by the continuation of the waiver, the waiver may be revoked. The revocation of a waiver may not be appealed. (h) Any substantive changes to the administrator-in-training program shall be submitted to the Commission for prior approval. (4) Policies and Procedures. The administrator shall: (a) In consultation with the governing body, develop and implement policies and procedures governing the operation of the facility, which include at a minimum those items in §F(1) and (2) of this regulation; and (b) Ensure that all policies and procedures are: (i) Reviewed by the governing body at least annually and are revised as necessary; (ii) Available at all times for staff inspection and use; and (iii) Appropriate personnel implement all policies and procedures adopted. #### Regulation .04 Freestanding Dialysis Facilities — Staffing. *COMAR 10.30.02.04* A. Nephrologist or Physician. (1) The director of a freestanding dialysis facility shall be a nephrologist or a physician with at least 1 year of experience in chronic hemodialysis. (2) Each freestanding dialysis facility shall have: (a) At least one additional nephrologist or physician trained in dialysis techniques to provide adequate continuous coverage; or (b) A licensed professional trained in dialysis. B. Medical Director. (1) Each freestanding dialysis facility shall appoint a medical director. (2) The medical director shall be a physician who is board eligible or board certified by the American Board of Internal Medicine or the American Board of Pediatrics and: (a) Has at least 12 months of experience or training in the care of patients at end-stage kidney disease facilities; or (b) Has served at least 12 months as a director of a dialysis or transplantation program before 1976. (3) The medical director shall: (a) Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility; (b) Supervise and be responsible for the overall medical, technical, and administrative functions of the freestanding dialysis facility including creation and enforcement of the freestanding dialysis facility's standards of care and basic operating procedures; (c) Coordinate the comprehensive kidney health care team to assure quality of care; (d) Assure there are written policies which address patient care plans to select the appropriate end stage kidney disease modality; (e) Assure that there are written policies outlining the freestanding dialysis facility's programs for in-center hemodialysis, home hemodialysis, and peritoneal dialysis modalities as applicable to that facility; (f) Assure that the end stage kidney disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed; (g) Assure the appropriate execution of the dialysis orders and day to day patient care policy by the nursing and technical staff; (h) Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects; (i) Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians; (j) Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques; (k) Supervise the development of a dialysis water standards policy including implementation, monitoring, and enforcement; (l) Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines; (m) Supervise the development of freestanding dialysis policies on the administration of intradialytic medications; (n) Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility; (o) Assure that there are written policies regarding patient care and facility personnel organization; (p) Assure that there are written policies regarding patient education; (q) Assure that there are written policies regarding medical staff bylaws and physician credentialing; (r) Assure that there are written policies regarding freestanding dialysis policies for anemia management, adequacy of dialysis measures, infection control, dialysis water standards, immunization guidelines for Hepatitis B, influenza, pneumococcal vaccines, and any other applicable vaccines, and use of Vitamin D analogues and monitoring parameters associated with the development of kidney osteodystrophy; (s) Assure quality improvement programs to monitor the facility policies and actively participate in the facility's quality improvement program; (t) Assure attending physicians comply with State and federal mandates applicable to the freestanding dialysis facility; (u) Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and (v) Establish documented practice goals within the freestanding dialysis facility to assure optimal patient care. C. Nursing Services. (1) Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility that: (a) Is a full time employee of the facility; (b) Is a registered nurse; (c) Has at least: (i) 12 months of experience in clinical nursing; and (ii) An additional 6 months experience in providing nursing care to patients on maintenance dialysis; and (d) Participates in the facility's Quality Assessment and Performance Improvement Program. (2) Charge Nurse. The charge nurse responsible for each shift: (a) Shall be a registered nurse; (b) Shall be on duty in the treatment area, at all times when patients are being treated, except for while on breaks, when the charge nurse shall be readily available; (c) Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and (d) May not be included in the staffing ratio except: (i) When there are nine or fewer patients; or (ii) In the event of an emergency. (3) Staffing Exception Reporting. (a) The freestanding dialysis facility shall have a staffing exception reporting protocol in a format approved by the Commission for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include: (i) The date and shift of the exception; (ii) A description of the emergency staffing situation; (iii) Actions taken in response; and (iv) Any measures taken to ensure the center's future compliance. (b) The exception reporting protocol shall be included in the center's quality assurance process. (c) The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(3)(a) of this regulation. D. Direct Patient Care Providers. (1) Staffing Ratio. (a) The monitoring individual-to-patient ratio at each facility shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients. (b) The facility shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (2) A monitoring individual shall: (a) Be trained in dialysis procedures and may be a: (i) Physician; (ii) Physician assistant; (iii) Nurse practitioner; (iv) Registered nurse; (v) Licensed practical nurse; or (vi) Certified nursing assistant—dialysis technician; and (b) Provide direct patient care during treatment, which shall include at a minimum: (i) Initiation of treatment; (ii) Termination of treatment; and (iii) Monitoring vital signs. (3) The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility. E. Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment. F. The freestanding dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients. G. Psychiatric services may be obtained by referral to a licensed psychiatrist. H. Social Worker. (1) The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility. (2) Annual Psychosocial Update. (a) A comprehensive annual psychosocial update shall be conducted annually or more often if indicated. (b) The annual psychosocial update shall include, at a minimum, the issues below: (i) Review of treatment options; (ii) Vocational rehabilitation; (iii) Adjustment to illness issues; (iv) Patient behaviors that may warrant discharge; and (v) Any changes in the patient's relationships, living situation, and living wills. (c) The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(3)(a) of this regulation. (3) The social worker shall document progress notes: (a) At least quarterly for stable patients; and (b) At least monthly or more frequently for unstable patients including, but not limited to, patients experiencing: (i) Adult Protective Services or Child Protective Services involvement; (ii) Housing crisis or change; (iii) Change in support system if patient is a vulnerable adult or child; (iv) Violent or abusive behaviors or events; (v) Emotional or psychological crisis including suicidal tendencies or emotional distress; (vi) Death or major illness in the family; (vii) Financial crisis interfering with the patient's ability to secure food, transportation, or medication; (viii) Extended or frequent hospitalizations; (ix) Marked deterioration in health status or in functional status; or (x) Situations that would warrant social work intervention. (4) The social worker's progress notes shall contain, at a minimum: (a) Documentation of the patient's adjustment to dialysis; (b) Patient behaviors that may warrant discharge; (c) Any referrals made to outside agencies; and (d) Follow-up of psychosocial issues identified in previous social work notes or the assessment or update. (5) The social worker shall: (a) Recommend changes in treatment based on the patient's psychosocial needs; (b) Provide case work and group work services to patients and their families in dealing with the special problems associated with end stage kidney disease; (c) Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and (d) Participate in continuous quality improvement activities and patient care planning. #### Regulation .05 Nocturnal Hemodialysis Programs. *COMAR 10.30.02.05* A. Nephrologist. (1) The director of a freestanding dialysis facility shall be a nephrologist with at least 1 year of experience in chronic hemodialysis. (2) A freestanding dialysis facility shall have at least one additional nephrologist trained in dialysis techniques to provide adequate continuous coverage. B. Medical Director. (1) A freestanding dialysis facility shall appoint a medical director. (2) The medical director shall be a physician who is board eligible or board certified by the American Board of Internal Medicine or the American Board of Pediatrics. (3) The medical director shall: (a) Assure that the facility has documented eligibility criteria for the nocturnal dialysis patient; (b) Determine the patient’s appropriateness and suitability for nocturnal hemodialysis by considering and documenting the patient’s: (i) Overall medical condition, including whether the patient is hemodynamically stable; (ii) Expectations for care; (iii) Response to in-center, daytime hemodialysis; and (iv) Availability of transportation; (c) Document the patient’s appropriateness for nocturnal hemodialysis in the patient’s medical record, including assessments and plans of care; (d) Assure that an order from a nephrologist, nurse practitioner, or physician assistant for nocturnal hemodialysis is written; (e) Assure that only patients accepted into a nocturnal hemodialysis program shall dialyze on a nocturnal dialysis shift; (f) Assure that quality medical care and technical expertise are provided in the freestanding dialysis facility; (g) Supervise and be responsible for the overall medical, technical, and administrative functions of the freestanding dialysis facility including creation and enforcement of the freestanding dialysis facility's standards of care and basic operating procedures; (h) Coordinate the comprehensive kidney health care team to assure quality of care; (i) Assure there are written policies which address plans to select the appropriate end-stage kidney disease modality; (j) Assure that there are written policies outlining the freestanding dialysis facility's programs for in-center hemodialysis, home hemodialysis, and peritoneal dialysis modalities as applicable to that facility; (k) Assure that the end-stage kidney disease patient has appropriate consultation with a renal dietitian, renal social worker, and other individuals as needed; (l) Assure the appropriate execution of the dialysis orders and day-to-day patient care policy by the nursing and technical staff; (m) Assure attending physician education and compliance with the freestanding dialysis facility policies on patient care and technical aspects; (n) Participate in the selection of available treatment modalities and dialysis supplies to be offered by the freestanding dialysis facility and advise attending physicians; (o) Approve policies and procedures ensuring the adequate training of nurses and technicians in dialysis science and techniques; (p) Supervise the development of a dialysis water standards policy, including implementation, monitoring, and enforcement; (q) Supervise the development of a freestanding dialysis facility-specific policy on the adequacy of dialysis, which complies with State and federal guidelines; (r) Supervise the development of freestanding dialysis policies on the administration of intradialytic medications; (s) Assure that there are written policies regarding patient medical records, physical environment, fire safety, and emergency preparedness of the freestanding dialysis facility; (t) Assure that there are written policies regarding patient care and facility personnel organization; (u) Assure that there are written policies regarding patient education; (v) Assure that there are written policies regarding medical staff bylaws and licensed and certified staff credentialing; (w) Assure that there are written freestanding dialysis policies for: (i) Anemia management; (ii) Adequacy of dialysis measures; (iii) Dialysis water standards; (iv) Immunization guidelines for Hepatitis B, influenza, pneumococcal, and any other applicable vaccines; (v) Use of Vitamin D analogues; and (vi) Monitoring parameters associated with the development of kidney osteodystrophy; (x) Assure quality improvement programs to monitor the facility policies and actively participate in the facility's quality improvement program; (y) Assure attending physicians and any other licensed or certified personnel comply with State and federal mandates applicable to the freestanding dialysis facility; (z) Assure attending physicians round on their patients at least monthly and document such on the patient's progress notes; and (aa) Establish documented practice goals within the freestanding dialysis facility, which should assure optimal patient care. C. Nursing Services. (1) Nurse Manager. The facility shall have a nurse manager responsible for nursing services in the facility who: (a) Is a full-time employee of the facility; (b) Is a registered nurse; (c) Has at least: (i) 12 months of experience in clinical nursing; and (ii) An additional 6 months of experience in providing nursing care to patients on maintenance dialysis; and (d) Participates in the facility's Quality Assessment and Performance Improvement Program. (2) Charge Nurse. The charge nurse responsible for each shift shall: (a) Be a registered nurse; (b) Be on duty in the treatment area at all times when patients are being treated, except for while on breaks when the charge nurse shall be readily available; and (c) Have at least 12 months of experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis. D. Direct Patient Care Providers. (1) Staffing Ratio. (a) Nocturnal Hemodialysis. When nocturnal hemodialysis is performed, the monitoring individual-to-patient ratio at each center for in-center nocturnal hemodialysis: (i) Shall be a minimum of one staff member to five participants; and (ii) May be sufficient to meet the needs of the patients. (b) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (c) The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients. (2) A monitoring individual shall: (a) Be trained in dialysis procedures and may be a: (i) Physician; (ii) Physician assistant; (iii) Nurse practitioner; (iv) Registered nurse; (v) Licensed practical nurse; or (vi) Certified nursing assistant—dialysis technician; and (b) Provide direct patient care during treatment, which shall include, at a minimum: (i) Initiation of treatment; (ii) Termination of treatment; and (iii) Monitoring vital signs. (3) The Commission shall decide if this minimum standard may be too low for a particular freestanding dialysis facility. E. Technical assistance by qualified personnel shall be available for the repair and maintenance of equipment. F. The freestanding dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients. G. Psychiatric services may be obtained by referral to a licensed psychiatrist. H. Social Worker. (1) The social worker shall conduct comprehensive psychosocial assessment within 30 days of the patient initiating treatment at the dialysis facility. (2) Annual Psychosocial Update. (a) A comprehensive annual psychosocial update shall be conducted annually or more often if indicated. (b) The annual psychosocial update shall include, at a minimum, the following issues: (i) Review of treatment options; (ii) Vocational rehabilitation; (iii) Adjustment to illness issues; (iv) Patient behaviors that may warrant discharge; and (v) Any changes in the patient's relationships, living situation, and living wills. (c) The annual psychosocial update may be included with the mandatory quarterly documentation for psychosocially stable patients. (3) The social worker shall document progress notes: (a) At least quarterly for stable patients; and (b) At least monthly or more frequently for unstable patients, including but not limited to, patients experiencing: (i) Adult Protective Services or Child Protective Services involvement; (ii) Housing crisis or change; (iii) Change in support system if patient is a vulnerable adult or child; (iv) Violent or abusive behaviors or events; (v) Emotional or psychological crisis including suicidal tendencies or emotional distress; (vi) Death or major illness in the family; (vii) Financial crisis interfering with the patient's ability to secure food, transportation, or medication; (viii) Extended or frequent hospitalizations; (ix) Marked deterioration in health status or in functional status; or (x) Situations that would warrant social work intervention. (4) The social worker's progress notes shall contain, at a minimum: (a) Documentation of the patient's adjustment to dialysis; (b) Patient behaviors that may warrant discharge; (c) Any referrals made to outside agencies; and (d) Follow-up of psychosocial issues identified in previous social work notes or the assessment or update. (5) The social worker shall: (a) Recommend changes in treatment based on the patient's psychosocial needs; (b) Provide case work and group work services to patients and their families in dealing with the special problems associated with end-stage kidney disease; (c) Identify community agencies and other resources and assist patients and families in accessing and utilizing them; and (d) Participate in continuous quality improvement activities and patient care planning. #### Regulation .06 Home Dialysis Programs. *COMAR 10.30.02.06* A. Location and Program Affiliation. (1) Home hemodialysis or peritoneal dialysis programs, or both, may be situated in either a dialysis facility or hospital, as long as the appropriate standards are satisfied. (2) To assure quality and continuity of patient care, the home dialysis program shall negotiate a formal affiliation agreement compliant with this subtitle. (3) The home dialysis program shall be affiliated with a certified transplantation center. (4) Home dialysis programs shall provide sufficient backup dialysis stations through specific affiliation agreements with certified dialysis facilities. (5) Home dialysis training performed by dialysis centers or facilities shall also meet the standards established in this regulation. (6) Home dialysis programs shall make arrangements for appropriate medical records, patient care policies, dietetic services, social services, sanitation standards, and fire and safety standards. (7) Patients dialyzing at home shall keep records of dialysis treatments and supplies used. B. Physical and Medical Standards. (1) Home dialysis programs shall: (a) Contain a dialysis station for training with either beds or chairs; (b) Contain floor space that assures usable space of at least 80 square feet of floor space per patient station that may include bed or chair space, nursing space, and work area, but excludes storage space; (c) Contain space to be sufficiently flexible to provide access to any of the four extremities; (d) Provide appropriate provisions to assure patient privacy; (e) Provide refrigerated and nonrefrigerated storage space; (f) Provide sufficient area and space for: (i) Maintenance of equipment; (ii) Storage of the equipment and supplies; and (iii) Preparing and testing dialyzers; (g) Utilize water of sufficient purity to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements; and (h) Provide adequate backup center dialysis. (2) Training. (a) The home dialysis program shall maintain a written training manual and program that shall be available and approved by the Commission. (b) The home dialysis program shall have patient training manuals available for patient utilization at times other than the dialysis procedure. (c) The home dialysis program shall provide visual aids to complement instructional programs. (d) It is generally accepted that training periods will vary depending on the needs of the patient and on the intensity and planning of the program. (e) The training program shall also test the availability and purity of the water supply in the patient's home before home hemodialysis is instituted. (f) The Commission shall review the training manual and program to determine if the length of training time is sufficient. C. Staffing. (1) Nephrologist and Additional Licensed Staff. (a) The director of the home dialysis program shall be a nephrologist with at least 1 year of experience in chronic dialysis including experience in home dialysis training. (b) One additional nephrologist, physician’s assistant, or certified registered nurse practitioner trained in dialysis shall be available to provide adequate continuous coverage. (2) Medical Director. A home dialysis program shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter. (3) Additional Home Dialysis Program Requirements. (a) Home dialysis programs shall maintain a minimum nursing staff requirement of one nurse per two training stations. (b) The nurse in charge of training shall have at least 12 months experience in providing nursing care including 6 months of experience in dialysis and 3 months of experience in the specific modality for which the nurse will provide self-care training. (c) Technical assistance by qualified personnel shall be available for the repair and maintenance of dialysis equipment in the home dialysis program and homes. (d) Home dialysis programs shall assure that adequate personnel are available to provide periodic follow-up home visits to patients on home dialysis programs. (e) The training programs shall have adequate social services and dietetic staffing by licensed and trained professionals. (f) Psychiatric services may be obtained by referral to a licensed psychiatrist. (g) In dialysis programs providing home dialysis training, dialysis personnel responsible for staffing the dialysis programs may participate in home dialysis training as long as the staffing ratio standards are met. (4) Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04H of this chapter. D. Administration. (1) The administration of the home dialysis program shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request. (2) The home dialysis program shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost. E. Compliance. Home dialysis programs shall comply with the provisions set forth in this subtitle for certification purposes with the Commission. #### Regulation .07 Self-Care Dialysis Facilities. *COMAR 10.30.02.07* A. Location and Program Affiliation. (1) Self-care dialysis facilities may be situated in free-standing dialysis facilities as long as appropriate standards are satisfied. (2) To assure quality and continuity of patient care, including backup dialysis, the self-care dialysis facility or a hospital shall negotiate a formal affiliation agreement compliant with this subtitle. (3) Self-care dialysis facilities shall make arrangements for appropriate medical records, patient care policies, sanitation standards, and fire and life safety standards as defined in federal regulations for Medicare Programs and those of the Commission. (4) Self-care dialysis facilities shall keep records of dialysis frequency and other factors relating to cost determination. (5) For the purpose of protecting patient safety and welfare, a self-care dialysis facility may not withdraw or phase out services until: (a) The self-care dialysis facility has notified the Commission as soon as possible of the self-care dialysis facility's intention to discontinue services; (b) Patients being treated by that self-care dialysis facility have been transferred to another facility or the patients' continuing care assured to the satisfaction of the patients and the Commission; (c) The self-care dialysis facility submits to the Commission evidence that transfer of patients to another facility has been satisfactorily accomplished; and (d) Patients previously certified and being treated in a self-care dialysis facility that is being withdrawn from the Kidney Disease Program continue to have access to the same reimbursement principles of the Kidney Disease Program. B. Physical Standards. (1) A self-care dialysis facility shall: (a) Make available adequate floor space that may include bed or chair space, nursing space, and work area, but excludes storage space; (b) Arrange the space to be sufficiently flexible to provide access to any of the four extremities; (c) Provide patient privacy and comfort; (d) Provide refrigerated and nonrefrigerated storage space; (e) Provide sufficient work area and space for: (i) Maintenance of equipment; (ii) Storage of equipment and supplies; and (iii) Preparing and testing dialyzers; and (f) Utilize water of sufficient purity, according to current Association for the Advancement of Medical Instrumentation recommendations which are incorporated by reference in this subtitle to prevent bacterial contamination, endotoxin, or toxic accumulation of trace elements in patients undergoing long-term dialysis. (2) Training. Self-care dialysis facilities shall provide training that includes: (a) Visual aids to complement the instructional program; and (b) Training periods that vary depending on the various needs of the patient and training program of the self-care dialysis facility. C. Staffing. (1) Nephrologist and Additional Licensed Staff. (a) The director of the self-care dialysis facility shall be a nephrologist with at least 1 year of experience in chronic dialysis. (b) At least one additional nephrologist, physician’s assistant, or certified registered nurse practitioner trained in dialysis shall be available to provide adequate continuous coverage. (2) Medical Director. A self-care dialysis facility shall appoint a medical director with the qualifications and responsibilities set forth in Regulation .04B(2) and (3) of this chapter. (3) Additional Self-Care Dialysis Facilities Requirements. (a) Direct patient care providers shall be trained in dialysis procedures and may be a: (i) Registered nurse; (ii) Licensed practical nurse; or (iii) Certified nursing assistant—dialysis technician. (b) A charge nurse: (i) Shall be a registered nurse; (ii) Shall be on duty in the treatment area, except for while on breaks, when the charge nurse shall be readily available, at all times when patients are being treated; (iii) Shall have at least 12 months experience in providing nursing care, including 6 months of experience in providing nursing care to patients on maintenance dialysis; and (iv) May not be included in the staffing ratio except when there are nine or fewer patients or in the event of an emergency. (c) Staffing Exception Reporting. The facility shall have a staffing exception reporting protocol in a format approved by the Commission for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum: (i) The date and shift of the exception; and (ii) A description of the emergency staffing situation. (d) Additional staffing may be achieved with the use of licensed practical nurses or certified nursing assistant—dialysis technicians. (e) Supervisory nursing personnel, which includes the charge nurse, may not be included in the calculation of staff/patient ratio if the supervisory nursing personnel do not participate in the monitoring of dialysis. (4) Technical assistance by qualified technicians shall be available for the repair and maintenance of equipment. (5) In addition, the self-care dialysis facility shall have sufficient social service and dietetic staffing by licensed and trained professionals available to meet the needs of the dialysis patients. (6) The self-care dialysis facility shall have psychiatric services available to patients by referral. (7) Social Worker. The social worker shall comply with the duties and responsibilities set forth in Regulation .04H of this chapter. D. Administration. (1) The administration of the self-care dialysis facility shall provide a copy of the Medicare cost report to the Department, or the Department's duly authorized agents, upon request. (2) The self-care dialysis facility shall provide designated administrative assistance to keep the necessary records as well as other information needed for accurate determination of cost. E. Compliance. Self-care dialysis programs shall comply with the provisions set forth in this subtitle for certification purposes with the Commission. ### Chapter 03 — Transmissible Diseases **Authority:** Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland **Administrative History:** Effective date: December 22, 2003 (30:25 Md. R. 1846) **Administrative History:** Regulation .01 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .02 amended effective April 5, 2010 (37:7 Md. R. 571); August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .03A, B, C amended effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .04 amended effective April 5, 2010 (37:7 Md. R. 571) #### Regulation .01 Incorporation by Reference. *COMAR 10.30.03.01* Control of Communicable Diseases Manual which can be found in depository libraries under COMAR 10.06.01.01-1 is incorporated by reference. #### Regulation .02 Unrestricted Access to Care. *COMAR 10.30.03.02* A. An end stage kidney disease patient with any transmissible disease, may not be denied dialysis or transplantation by a certified Maryland dialysis or transplantation facility solely because of the potential for transmission of the transmissible disease, to other patients or treatment personnel. B. If tours of the dialysis facility take place, the facility shall inform visitors of the risk of transmissible disease exposure and encourage thorough hand washing at the end of the tour. #### Regulation .03 Preventive Measures. *COMAR 10.30.03.03* A. A facility shall follow the infection control procedures established in the Control of Communicable Diseases Manual designed by the Centers for Disease Control and Prevention (CDC) to control the spread of transmissible diseases. B. General. (1) The cardinal measure for preventing the spread of transmissible diseases is an understanding on the part of dialysis and transplantation personnel that each end-stage kidney disease patient is potentially a transmitter of transmissible diseases. (2) Hand Washing. (a) Dialysis personnel shall practice thorough hand washing, per the Control of Communicable Diseases Manual, between successive contacts with dialysis patients. (b) Dialysis facilities and transplant centers shall contain adequate hand washing facilities within the patient care area. (3) Dialysis facilities and transplant centers shall conduct an in-service training session for transmissible disease including hepatitis and the control of hepatitis for newly employed dialysis personnel before the dialysis personnel may participate in patient care, and at least annually for all dialysis personnel. (4) Dialysis facilities and transplant centers shall establish and enforce written procedures to implement the control of transmissible disease including viral hepatitis as set forth in the Control of Communicable Diseases Manual. (5) Hepatitis B vaccine is recognized to be effective in producing immunity and is recommended for all staff and patients who are susceptible to hepatitis B virus infection. (6) Dialysis facilities and transplant centers shall document testing to demonstrate active immunity by appropriate antibody titers. (7) Hepatitis testing shall be conducted on patients and staff according to the Control of Communicable Diseases Manual. C. Infection Control and Hygiene. (1) To the extent possible, the dialysis facility shall physically separate, in time or space, patients who are antigen positive from those who are antigen negative. (2) Dialysis personnel shall: (a) Wear personal protective equipment (PPE) at all times while providing patient care in the treatment area; (b) Be properly bandaged to prevent contact with blood or other bodily fluids, if dialysis personnel have lesions on any body parts; (c) Wear PPE in activities and situations where contact with blood or other potentially infectious secretions may occur; (d) Dispose of used gloves immediately upon completion of any procedure and practice thorough hand washing before any other patient contact; (e) Take necessary precautions to avoid contact with contaminated surfaces and clothing and carefully clean contaminated surfaces with a suitable disinfectant immediately after the patient's dialysis session is ended; and (f) Remove and dispose of station coverings immediately after the patient's dialysis session has ended and thoroughly sanitize the dialysis station. (3) A dialysis facility may not permit staff members or visitors to eat, drink, or smoke in the treatment area. (4) A dialysis facility shall follow the advice of the Centers for Disease Control and Prevention (CDC) for staff immunization and surveillance for hepatitis B. D. Disposal. (1) Dialysis facilities shall assure that waste and disposable items are packaged or wrapped on the premises of the facility in plastic-lined containers which shall be clearly identified as possibly contaminated materials either by labels or color-coding. (2) Before including used needles in the specially identified containers described in §D(1) of this regulation, dialysis personnel shall place these needles in separate, rigid containers. (3) The dialysis facility shall incinerate or make arrangements for the incineration of the dialysis facility's waste in accordance with local, State, or federal regulations. E. Decontamination. The dialysis facility shall assure that personnel place used linens, scrub clothes, gowns, and laboratory coats in transport bags clearly identified as possibly contaminated material either by labels or color-coding, and that: (1) Individuals subsequently handling these materials are aware of potential contamination; and (2) Specimens issuing from dialysis facilities are appropriately treated and identified as possibly contaminated material either by labels or color-coding. #### Regulation .04 Detection Measures. *COMAR 10.30.03.04* Dialysis facilities and transplant centers shall develop quality assessment and performance improvement (QAPI) measures for the surveillance of infection control practices. ### Chapter 04 — Dialyzer Reuse and Water Standards **Authority:** Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland **Administrative History:** Effective date: December 22, 2003 (30:25 Md. R. 1846) **Administrative History:** Regulation .01B amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .02 repealed effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .03 amended effective April 5, 2010 (37:7 Md. R. 571) **Administrative History:** Regulation .03 amended and recodified to Regulation .02 effective August 18, 2025 (52:16 Md. R. 846) #### Regulation .01 Incorporation by Reference. *COMAR 10.30.04.01* A. In this chapter, the following documents are incorporated by reference. B. Documents Incorporated. (1) 42 CFR §494.40, as amended; and (2) 42 CFR §494.50, as amended. #### Regulation .02 Water Standards — Water Treatment System — Dialysis Facilities. *COMAR 10.30.04.02* A. The dialysis facility shall record in a log system malfunctions or temporary failures to meet standards. Extended failure of 1 day or longer is unsuitable and out of compliance with these regulations. B. The dialysis facility shall report system malfunctions at once to: (1) The Office of Health Care Quality of the Department; (2) The supplier as to the unprotected state of the dialysis facility; and (3) The Commission. C. If the freestanding dialysis facility experiences a water system failure that may threaten patient health or safety, the facility shall cease operations and implement its policies and procedures for handling emergencies, as provided in 42 CFR §494.40, which is incorporated by reference. D. Each freestanding dialysis facility shall communicate water treatment issues with their local health emergency management agency and their local health officer. E. Boiled Water Advisory. (1) A facility may dialyze patients under a boiled water advisory if the water treatment components in use protect the product water from having chemical and microbial contamination. (2) The facility shall have policies and procedures in place to identify the person responsible for monitoring the water quality and how often the treated water will be monitored. (3) The medical director shall assure close monitoring of the product water under the boiled water advisory. (4) If a deionization (DI) unit is being used as the main water treatment system, a submicron or endotoxin/ultrafilter downstream of the DI unit, diverted to the drain, shall be in place. (5) If a deionization (DI) unit is being used as the main water treatment system: (a) The deionization systems shall be monitored continuously: (i) To produce water of one megohm/cm or greater specific resistivity; and (ii) Using resistivity monitors that compensate for temperature and are equipped with audible and visual alarms which are audible in the patient care area; (b) The audible and visible alarm shall be activated when the product water resistivity falls below 1.0 megohm/cm and the product water shall be prevented from reaching any point of use; and (c) A submicron or endotoxin/ultrafilter downstream of the DI unit shall be in place. (6) If an ultraviolet (UV) irradiator is used, the ultrafilter shall be: (a) Located after the UV irradiator; and (b) Monitored to detect any decrease in treated water quality. (7) The facility shall perform weekly microbial assessment of the product water during the boiled water advisory. (8) The facility shall maintain contact with the municipal water supplier in the event the water supplier chooses to “shock” treat (hyperchlorinate) the distribution system to bring it back into compliance with the acceptable standards for drinking water. (9) The facility shall contact the municipal water supplier at least annually in writing to identify their location, contact information and the needs of the dialysis facility during any water service interruption. (10) Shocking of Water System. (a) In the event the municipal water supplier “shocks” the water system, chlorine/chloramine break through may occur. Water system testing procedures shall be reviewed with staff by the medical director to alert them for potential chlorine/chloramines break through so that patients will be protected from exposure to chlorine/chloramine. (b) Every half-hour, the facility shall: (i) Monitor the feed water for any increase in chlorine/chloramine; and (ii) Test for chlorine/chloramine breakthrough after the first carbon filter. (c) The half-hour testing described in §E(10)(b) of this regulation shall continue until 24 hours after feed water results return to normal. ### Chapter 05 — Fee Schedule **Authority:** Health-General Article, §§13-301 — 13-316 and 16-204, Annotated Code of Maryland **Administrative History:** Effective date: December 22, 2003 (30:25 Md. R. 1846) #### Regulation .01 Scope. *COMAR 10.30.05.01* This chapter governs dialysis facilities and transplant centers, except those exempted by statute, that are certified by the Commission for eligibility for reimbursement by the Kidney Disease Program for performance of dialysis or transplantation on certified patients with end-stage renal disease. #### Regulation .02 Fees. *COMAR 10.30.05.02* The following certification fees are established by the Commission and may be prorated for initial certification of a partial year: A. Facilities with 0 — 39 patients ... $693; B. Facilities with 40 — 49 patients ... $1,274; C. Facilities with 50 or more patients ... $1,500; D. Late fee ... 10 percent of fee; and E. Facility roster fee (fee may be waived for patients) ... $55. #### Regulation .03 Terms. *COMAR 10.30.05.03* A. A facility shall pay to the Commission the certification fees set forth in Regulation .02 of this chapter within 30 days of the date that they are billed. B. The Commission shall bill a facility within 30 days of the facility's certification or verification of the facility's certification by the Commission. C. Billing shall be done on an annual basis. D. The term of the certification is 1 year and is renewed on an annual basis. E. Initial certification is only for the term of the current certification year. F. A late fee of 10 percent of the assessed certification fee shall be charged in addition to the certification fee if payment is received more than 30 days after the due date. G. A facility that fails to pay the certification fee, plus the late fee, more than 60 days after the due date shall be decertified. H. The facility may not charge the patient for those fees which the Kidney Disease Program would have paid, had the facility complied with this subtitle. #### Regulation .04 Prohibitions. *COMAR 10.30.05.04* A facility or center may not receive funds from the Kidney Disease Program for certified services rendered, unless the facility is certified by the Commission and has paid in full the fee assessed it by the Commission in the time limit set forth by the Commission. #### Regulation .05 Fund Administration. *COMAR 10.30.05.05* The Chairman of the Commission or the Chairman's designee shall administer the Kidney Disease Fund as established under Health-General Article, §13-310.1, Annotated Code of Maryland. ## Subtitle 31 — Health Occupation Boards ### Chapter 01 — Code of Conduct for Board Members and Investigators **Authority:** Health-General Article, §2-104; Health Occupations Article, §§1-203, 1A-205, 2-205, 3-205, 4-205, 5-205, 6-206, 7-205, 9-205, 10-205, 11-205, 12-205, 13-206, 14-205, 16-205, 17-205, 18-206, 19-205, 20-205 and 21-205; Annotated Code of Maryland **Administrative History:** Effective date: July 24, 2000 (27:14 Md. R. 1341) #### Regulation .01 Scope. *COMAR 10.31.01.01* A. This chapter establishes a code of conduct for members of health occupation boards within the Maryland Department of Health and for investigators employed by the health occupation boards. B. This chapter does not apply to the Board of Nursing. The Board of Nursing's Code of Conduct regulations are set forth in COMAR 10.27.23. #### Regulation .02 Definitions. *COMAR 10.31.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means a health occupation board regulated under the Health Occupations Article or the Health-General Article, Annotated Code of Maryland, with the exception of the Board of Nursing. (2) “Board member” means an individual appointed by the Governor to serve on a Board. (3) “Charging document” means the notice from the board pursuant to State Government Article, §10-208, Annotated Code of Maryland, which informs a licensee of an alleged violation or violations of a board's statute by the licensee. (4) “Complaint” means a communication to a board of a possible violation of the disciplinary provisions of a Maryland licensing statute by a licensee. (5) “Conflict of interest” means a situation in which a personal interest of a board member or a board investigator presents a potential conflict with the public interest in connection with an anticipated public action or decision. (6) “Ex parte communication” means a direct or indirect communication between a board member and another party regarding the merits of an issue in a pending contested disciplinary case if the communication is made outside the presence of the opposing party in the case. (7) “Investigator” means an individual who investigates complaints received by a health occupation board. (8) Liaison. (a) “Liaison” means a board member designated by the board to provide practitioner expertise to the investigator or prosecutor, or both, pertaining to a specific complaint. (b) “Liaison” does not mean a board member who participates only in a preliminary review of a complaint. (9) “Recusal” means nonparticipation of a board member in a specific matter before the Board. #### Regulation .03 Recusal of Board Members. *COMAR 10.31.01.03* A. Standards for Recusal. (1) A Board member shall recuse himself or herself from board proceedings which involve situations in which the board member: (a) Has a conflict of interest; or (b) Cannot participate fairly and impartially. (2) Personal familiarity with a respondent does not, of itself, require recusal of a board member. B. Board Counsel Advice. A board member may seek the advice of the board's counsel in determining the need for recusal on a specific matter. C. Requirements Following Recusal. (1) The board member who is recused from a matter before the board may not: (a) Participate in the board's discussion or vote on the matter; or (b) Discuss the matter with other members of the board or discuss the board's review of the matter with other individuals. (2) If the matter before the board is a disciplinary matter, the board member who is recused shall physically leave the room to ensure nonparticipation. (3) The board shall document the recusal of the board member in the minutes of the board meeting. D. Complaint Against a Board Member. (1) A board member against whom a complaint is filed shall follow §C of this regulation for all discussion and voting concerning the complaint filed against the board member. (2) If the board determines that there is an additional matter before the board which is reasonably related to the complaint filed against the board member, the board member against whom the complaint is filed shall follow §C of this regulation for the additional matter also. (3) If, after investigation of the complaint, the board refers the case to the Attorney General's Office, the board member shall recuse himself or herself from all board activities until the final disposition of the case. E. Liaison. (1) A board member may not serve as a liaison on a complaint in which the board member has a conflict of interest. (2) A board member who serves as the liaison on a specific complaint may: (a) Participate in discussion of the complaint; (b) Vote on the decision regarding charges based on the complaint; and (c) Participate in the case resolution conference for the complaint. (3) A board member who serves as the liaison on a specific complaint may not: (a) Participate in a hearing on the complaint conducted by the board; or (b) Participate in the discussion or vote on the complaint following the hearing conducted either by the board or by the Office of Administrative Hearings (OAH) through authority delegated from the board. #### Regulation .04 Investigator. *COMAR 10.31.01.04* A. An investigator may not conduct or participate in an investigation of a complaint in which the investigator has a conflict of interest. B. In the investigation of a complaint against a member of a board, the board may consider using an investigator other than the one who is regularly assigned to conduct investigations for the board. #### Regulation .05 Confidentiality. *COMAR 10.31.01.05* A. A board member or investigator may not discuss disciplinary or other confidential matters with an individual other than: (1) A board member; (2) Board staff; (3) The Attorney General's Office; (4) A witness; or (5) Another individual authorized by law to be involved in the case. B. In the case of an ex parte communication, the board member shall follow the provisions of State Government Article, §10-219, Annotated Code of Maryland. ### Chapter 02 — Tax Compliance Regulations **Authority:** Health Occupations Article, §§1-213, 1A-205, 2-205, 3-205, 4-205, 5-205, 7-205, 8-205, 9-205,10-205, 11-205, 12-205, 13-206, 14-205, 16-205, 17-205, 18-206, and 19-205, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.02 adopted as an emergency provision effective July 1, 2003 (30:19 Md. R. 1327); adopted permanently effective December 11, 2003 (30:24 Md. R. 1741) **Administrative History:** Regulation .01 amended effective March 15, 2004 (31:5 Md. R. 449) **Administrative History:** Regulation .01B amended effective March 12, 2018 (45:5 Md. R. 286) #### Regulation .01 Definitions. *COMAR 10.31.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means a health occupation board regulated under the Health Occupations Article, Annotated Code of Maryland, with the exception of the Board of Nursing. (2) “Delinquent” means the failure by a certificate holder, licensee, registration holder, or permit holder, to pay all undisputed taxes and unemployment insurance contributions, as determined by the Office of the Comptroller or the Secretary of Labor, that are payable to the Office of the Comptroller or the Secretary of Labor, in a manner satisfactory to the unit of the State responsible for collection of the payment. (3) “Renewal license” means any license, permit, certification, or registration granted by the Board for the period immediately following a period for which the person previously possessed the same or a substantially similar license, permit, certification, or registration. (4) “Verification” means a written or electronic notification created by the unit of the State responsible for collection of taxes or unemployment insurance contributions attesting that the renewal applicant is no longer delinquent. #### Regulation .02 Outstanding Taxes or Unemployment Insurance Contributions. *COMAR 10.31.02.02* A. If a renewal applicant has been identified as delinquent by the Office of the Comptroller or the Maryland Department of Labor, the Board shall issue a written notice to the renewal applicant stating that: (1) The renewal applicant has been identified by the Office of the Comptroller or the Maryland Department of Labor, as delinquent in the payment of taxes or unemployment insurance contributions as applicable; and (2) The renewal license will be denied if a verification is not submitted to the Board within 30 days after the notice is issued or before the expiration date of the current certificate, license, registration, or permit, whichever is later. B. If the Board does not receive a verification within 30 days after the Board issued the notice or before the expiration date of the current certificate, license, registration, or permit, whichever is later, the Board shall: (1) Deny the renewal license; and (2) Inform the renewal applicant in writing that the renewal license has been denied. ## Subtitle 32 — Board of Physicians ### Chapter 01 — General Licensure Regulations **Authority:** Health Occupations Article, §§1-213, 14-101, 14-205—14-207, 14-301, 14-302, 14-304—14-307, 14-310, 14-311, 14-313, 14-314, 14-316—14-318, 14-320, 14-320.1, 14-503, 14-505, and 14-606, Annotated Code of Maryland **Administrative History:** Effective date: May 7, 1971 **Administrative History:** Amended effective November 9, 1971; March 31, 1976 (3:7 Md. R. 401) **Administrative History:** Chapter revised effective March 16, 1977 (4:6 Md. R. 507) **Administrative History:** Regulation .02 amended effective July 25, 1980 (7:15 Md. R. 1425) **Administrative History:** Regulation .05B amended effective February 20, 1981 (8:4 Md. R. 342) **Administrative History:** Regulation .08C amended effective May 5, 1978 (5:9 Md. R. 684) **Administrative History:** Regulation .08D adopted effective February 20, 1981 (8:4 Md. R. 342) **Administrative History:** Regulations .09 and .10 adopted effective July 25, 1980 (7:15 Md. R. 1425) **Administrative History:** Chapter revised effective December 20, 1982 (9:25 Md. R. 2484) **Administrative History:** Regulation .04A adopted as an emergency provision effective June 1, 1983 (10:12 Md. R. 1070); emergency status extended at 10:15 Md. R. 1342 and 10:23 Md. R. 2060 **Administrative History:** Chapter revised effective January 30, 1984 (11:2 Md. R. 113) **Administrative History:** Regulation .11 adopted as an emergency provision effective July 1, 1991 (18:14 Md. R. 1607); emergency status expired January 1, 1992 (Emergency provisions are temporary and not printed in COMAR) **Administrative History:** Regulation .11 adopted effective January 2, 1992 (18:25 Md. R. 2751) **Administrative History:** Chapter revised effective August 1, 1994 (21:15 Md. R. 1306) **Administrative History:** Regulation .02B amended effective October 7, 1996 (23:20 Md. R. 1423); April 5, 1999 (26:7 Md. R. 543); October 2, 2000 (27:19 Md. R. 1725); June 25, 2001 (28:12 Md. R. 1110) **Administrative History:** Regulation .03 amended effective October 2, 2000 (27:19 Md. R. 1725); June 25, 2001 (28:12 Md. R. 1110); July 22, 2002 (29:14 Md. R. 1075) **Administrative History:** Regulation .03F amended effective October 7, 1996 (23:20 Md. R. 1423); April 5, 1999 (26:7 Md. R. 543) **Administrative History:** Regulation .03G amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .03G amended as an emergency provision effective October 28, 2002 (29:23 Md. R. 1807); amended permanently effective February 17, 2003 (30:3 Md. R. 180) **Administrative History:** Regulation .03G amended effective December 9, 2004 (31:24 Md. R. 1726); November 7, 2005 (32:22 Md. R. 1756); February 22, 2010 (37:4 Md. R. 341) **Administrative History:** Regulation .04 amended effective April 5, 1999 (26:7 Md. R. 543) **Administrative History:** Regulation .04B—E amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .05 amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .06C, E, H amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .08E, G—I amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .08K adopted effective April 5, 1999 (26:7 Md. R. 543) **Administrative History:** Regulation .09B, D amended effective October 7, 1996 (23:20 Md. R. 1423); October 20, 1997 (24:21 Md. R. 1450); April 17, 2000 (27:7 Md. R. 705) **Administrative History:** Regulation .10E amended effective April 5, 1999 (26:7 Md. R. 543) **Administrative History:** Regulation .10F amended and J adopted effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .11 amended effective April 5, 1999 (26:7 Md. R. 543); March 20, 2000 (27:5 Md. R. 705); April 2, 2001 (28:6 Md. R. 621) **Administrative History:** Regulation .12 amended effective December 29, 1997 (24:26 Md. R. 1759); April 17, 2000 (27:7 Md. R. 705) **Administrative History:** Regulation .13A amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .15A, D amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .16 amended effective July 22, 2002 (29:14 Md. R. 1075) **Administrative History:** Regulation .16B amended effective October 7, 1996 (23:20 Md. R. 1423) **Administrative History:** Regulation .17 amended effective October 7, 1996 (23:20 Md. R. 1423); April 5, 1999 (26:7 Md. R. 543) **Administrative History:** Regulation .17 repealed effective July 22, 2002 (29:14 Md. R. 1075) **Administrative History:** Chapter revised effective September 29, 2014 (41:19 Md. R. 1080) **Administrative History:** Regulation .02B amended effective August 26, 2019 (46:17 Md. R. 727) **Administrative History:** Regulation .03G amended effective August 7, 2023 (50:15 Md. R. 682) **Administrative History:** Regulation .04B amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .05 amended effective December 11, 2023 (50:24 Md. R. 1042) **Administrative History:** Regulation .06C amended effective August 26, 2019 (46:17 Md. R. 727) **Administrative History:** Regulation .08 amended effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .10 amended effective January 2, 2017 (43:26 Md. R. 1446); September 30, 2024 (51:19 Md. R. 854) **Administrative History:** Regulation .11 amended effective December 11, 2023 (50:24 Md. R. 1042) **Administrative History:** Regulation .11G amended effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .11I repealed effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .11I, J adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 298); emergency status expired effective July 3, 2022 **Administrative History:** Regulation .12 amended effective December 11, 2023 (50:24 Md. R. 1042) **Administrative History:** Regulation .12B amended effective April 23, 2018 (45:8 Md. R. 422) **Administrative History:** Regulation .12E amended effective July 20, 2015 (42:14 Md. R. 880) **Administrative History:** Regulation .13A amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .17 adopted effective June 19, 2017 (44:12 Md. R. 588) **Administrative History:** Regulation .17F adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 298); emergency status expired effective July 3, 2022 #### Regulation .01 Scope. *COMAR 10.32.01.01* These regulations govern how an individual becomes licensed in Maryland to practice medicine. #### Regulation .02 Definitions. *COMAR 10.32.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ABMS” means the American Board of Medical Specialties. (2) “ACCME” means the Accreditation Council on Continuing Medical Education. (3) “ACGME” means the Accreditation Council for Graduate Medical Education. (4) “Accredited training program” means a postgraduate clinical medical education program which is: (a) Certified by the: (i) Accreditation Council for Graduate Medical Education (ACGME) or its successor; or (ii) American Osteopathic Association (AOA) or its successor; (b) Accredited by the Royal College of Physicians and Surgeons of Canada (RCPSC) or its successor; (c) A postgraduate clinical medical education program that meets all of the following criteria: (i) Is in a specialty or subspecialty area, or both, that is not being accredited by the ACGME, AOA or RCPSC but meets all the requirements for accreditation of Accreditation Council for Graduate Medical Education, the American Osteopathic Association, or the Royal College of Physicians and Surgeons of Canada; (ii) Is directed by a physician who is actively licensed to practice medicine in the United States, its territories or possessions, Puerto Rico, or Canada; (iii) Is concurrently offered with ACGME-accredited programs; and (iv) Is taught at a hospital that is accredited by The Joint Commission or its successor or predecessor; or (d) A program conducted in the United States of America or Canada that is the equivalent of §B(3)(a), (b), or (c) of this regulation as determined by the Board of Physicians. (5) “AOA” means the American Osteopathic Association. (6) “Applicant” means an individual applying for initial licensure as a physician in Maryland. (7) “Application period” means the time between the Board's receipt of an application and the issuance of a license or the closure of an application through withdrawal, determination of ineligibility, or denial of application. (8) “Board” means the Board of Physicians. (9) “Board-certified” means the physician is certified by a public or private board, including a multidisciplinary board, and the certifying board is: (a) A member of ABMS; (b) An AOA certifying board; (c) The Royal College of Physicians and Surgeons of Canada; or (d) The College of Family Physicians of Canada. (10) “CME” means continuing medical education. (11) “ECFMG” means the Educational Commission for Foreign Medical Graduates or its successor. (12) “FCVS” means the Federal Credentialing Verification Services of the Federation of State Medical Boards of the United States, Inc. (13) “Federation” means the Federation of State Medical Boards of the United States, Inc. (14) “FLEX examination” means the Federation Licensing Examination designed by the Federation of State Medical Boards in cooperation with the National Board of Medical Examiners. (15) “FLEX weighted average” means the method of calculating the grade of the FLEX examination by which the test results on the first day count 1/6, the second day 2/6, and the third day 3/6. (16) “Foreign medical school” means a medical school located outside the United States or its territories, Canada, or Puerto Rico. (17) “LCME” means Liaison Committee on Medical Education, an organization that accredits programs in medical education leading to the doctor of medicine degree in the United States and territories and, in cooperation with the Committee on Accreditation of Canadian Medical Schools, in Canada. (18) “Oral Proficiency Interview (OPI)” means the examination of the American Council on the Teaching of Foreign Languages designed to evaluate the spoken English proficiency of those whose native language is not English. (19) "Orientation program” means a program of information approved by the Board which includes: (a) The statutes and regulations governing the practice of medicine in Maryland; (b) Boundary issues; and (c) The role and functions of the Board. (20) “Postgraduate training” means clinical and medical training for medical school graduates, including but not limited to, internships, residencies, and fellowships. (21) “Professional school” means a school whose curricula lead to a professional license, certification, or registration issued under the Health Occupations Article, Annotated Code of Maryland, including the medical school of graduation or the medical school, where an applicant obtained medical education, that is affiliated with the institution that conferred the medical degree on the applicant. (22) “Recertification” means successfully meeting all of the specified recertification requirements of a medical licensing authority or specialty board recognized by the Board. (23) “Speech impairment” means a disorder of the voice, articulation, speech sounds, or fluency in the speaker's native language. (24) “SPEX” means the Special Purpose Examination prepared by the Federation of State Medical Boards. (25) “Successfully completed year of postgraduate training” means: (a) 12 months of accredited postgraduate training in one integrated program in which the: (i) Applicant completed all the requirements; (ii) Program director rated the applicant's performance as satisfactory; and (iii) Applicant's performance was such that the applicant qualified for advancement without academic or clinical probationary conditions to the next year and next progressive level of responsibility in a designated specialty program; or (b) A year of accredited postgraduate training which the applicant completed in a manner that satisfied the requirements of §B(20-1)(a)(i) and (ii) of this regulation but that did not satisfy the requirements of §B(20-1)(a)(iii) of this regulation, and which was followed by a year of training which the applicant completed in a manner that satisfied all of the requirements of §B(20-1)(a) of this regulation. (26) “TOEFL” means the Test of English as a Foreign Language. (27) “USMLE” means the United States Medical Licensing Examination. #### Regulation .03 Licensure — Qualifications for Initial Licensure. *COMAR 10.32.01.03* A. Moral Character. The applicant shall be of good moral character. B. Age. The applicant shall be 18 years old or older. C. Fee. An applicant for initial licensure shall pay the initial application fee and any additional charges set by the Board. D. Education and Training. The applicant shall meet at least one of the following requirements: (1) Have a doctor of medicine degree from a school of medicine accredited by LCME at the time of the applicant's graduation and have successfully completed 1 year of postgraduate training at an accredited training program; (2) Have a doctor of osteopathy degree from a school of osteopathy in the United States, its territories or possessions, Puerto Rico, or Canada that has standards for graduation equivalent to those established by the American Osteopathic Association (AOA) and have successfully completed 1 year of postgraduate training at an accredited training program; (3) Have a doctor of medicine degree from any other medical school, have successfully completed the requirements for and obtained ECFMG certification, and have successfully completed 2 years of post-graduate training at an accredited training program; or (4) Have a document stating that the applicant has successfully completed a fifth pathway program as defined in Health Occupations Article, §14-308(a)(2), Annotated Code of Maryland, have successfully completed all of the formal graduation requirements of a foreign medical school except for the postgraduate or social service components as required by the foreign country or its medical school, and have successfully completed 2 years of postgraduate training at an accredited training program. E. On a case-by-case basis, the Board may consider full-time teaching in an LCME-accredited medical school in the United States as an alternative to the accredited postgraduate clinical medical education programs required in §D of this regulation. F. The Board may consider practice in another state of the United States or in Canada as an alternative to the accredited postgraduate clinical medical education program required in §D of this regulation if: (1) There is a minimum of 10 years clinical practice in the United States or Canada, with 3 years being within 5 years of the date of the application; and (2) The clinical practice occurred under a full unrestricted license to practice medicine. G. Examination. (1) An applicant for licensure in Maryland shall successfully complete at least one of the following examination requirements: (a) Achieve a passing score on all parts of the National Board of Medical Examiners examination as evidenced by an endorsement of certification issued by the National Board of Medical Examiners; (b) Achieve a score as follows: (i) At least 75 on each part of the FLEX examination; (ii) A FLEX weighted average score of at least 75 on a FLEX examination taken before 1985 and achieved in one sitting; or (iii) A FLEX weighted average score of at least 75 on a FLEX examination taken before 1985 and be currently certified by a member board of the American Board of Medical Specialties; (c) Achieve a passing score, as evidenced by receipt of either a Diplomate Certification or a Certification of Completion issued by the National Board of Osteopathic Medical Examiners after January 1, 1971, on: (i) All parts of the examination of the National Board of Osteopathic Medical Examiners (NBOME); (ii) All levels of the Comprehensive Osteopathic Medical Licensing Examination (COMLEX); or (iii) A combination of these examinations; (d) Achieve the recommended passing score on all levels of the Comprehensive Osteopathic Medical Licensing Exam of the National Board of Osteopathic Medical Examiners; (e) Achieve passing scores on any of the following examination combinations: (i) NBOME Part 1 + NBOME Part 2 + COMLEX Level 3; (ii) NBOME Part 1 + COMLEX Level 2 + COMLEX Level 3; (iii) NBOME Part 1 + COMLEX Level 2 + NBOME Part 3; (iv) COMLEX Level 1 + NBOME Part 2 + NBOME Part 3; (v) COMLEX Level 1 + COMLEX Level 2 + NBOME Part 3; or (vi) COMLEX Level 1 + NBOME Part 2 + COMLEX Level 3; (f) Achieve a passing score on all parts of the examination of any state board or the District of Columbia Board of Medicine in the United States; (g) Achieve a passing score on all steps of the United States Medical Licensing Examination (USMLE); (h) If completed before the year 2000, achieve passing scores on any of the following examination combinations: (i) USMLE Step 1 + NBME Part II + NBME Part III; (ii) USMLE Step 1 + USMLE Step 2 + NBME Part III; (iii) USMLE Step 1 + NBME Part II + USMLE Step 3; (iv) NBME Part I + USMLE Step 2 + USMLE Step 3; (v) NBME Part I + USMLE Step 2 + NBME Part III; (vi) NBME Part I + NBME Part II + USMLE Step 3; (vii) FLEX Component 1 + USMLE 3; (viii) FLEX Component 2 + USMLE Step 1 + NBME Part II; (ix) FLEX Component 2 + USMLE Step 1 + USMLE Step 2; (x) FLEX Component 2 + NBME Part I + USMLE Step 2; or (xi) FLEX Component 2 + NBME Part I + NBME Part II; or (i) Achieve a passing score on each part of the applicable qualifying examination of the Liceniate of the Medical Council of Canada. (2) An applicant who fails any part, step, level, or component of the examinations or combination of examinations listed in §G(1)of this regulation three or more times shall meet one of the requirements listed in §G(3) of this regulation. (3) An otherwise qualified applicant who passes the examination after having failed the examination or any part of the examinations listed in §G(1) of this regulation or any part, step, level, or component of any of the examinations listed in §G(1) three or more times may qualify for a license only if the applicant: (a) Has successfully completed 2 or more years of a residency or fellowship accredited by the ACGME or the AOA; (b) Has met the following requirements: (i) The applicant has a minimum of 5 years clinical practice of medicine in the United States or in Canada, with at least 3 of the 5 years having occurred within 5 years of the date of the application, that occurred under a full unrestricted license to practice medicine; and (ii) The applicant has no disciplinary action pending and has had no disciplinary action taken against the applicant that would be grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland; or (c) Is Board-certified. (4) Notwithstanding §G(1) of this regulation, the Board shall require an applicant to pass the SPEX examination or the Comprehensive Osteopathic Medical Variable-Purpose Examination—USA (COMVEX—USA) if the applicant: (a) Last passed a medical licensing examination more than 15 years before this application; (b) Has never had specialty board certification or last passed a specialty board certification examination given by a member board of the ABMS or the AOA more than 10 years before this application; (c) Has not had a full, unrestricted medical license in at least one state of the United States or Canada within the 10-year period before this application; and (d) Has not actively practiced clinical medicine in the United States or Canada for at least 7 of the 10 years before this application. (5) Notwithstanding §G(1) of this regulation, the Board may require an applicant to pass the SPEX examination or the Comprehensive Osteopathic Medical Variable-Purpose Examination — USA (COMVEX — USA) if the applicant meets one or more of the conditions listed in §G(4) of this regulation. H. Additional Requirements. (1) Each applicant shall submit a chronological list of all activities beginning with the date of completion of medical school through the date of application. The activities shall be listed by month and year, account for all periods of time, and include but not be limited to the following: (a) All postgraduate training programs attended, regardless of whether the program was completed or not; (b) Each job held, regardless of whether the job was: (i) Medically related or not; or (ii) Compensated or not; (c) Any other activity engaged in, including all periods of unemployment; (d) An action, by a state licensing or disciplinary board, or a comparable body in the armed services, denying an application for licensure, reinstatement, or renewal; (e) An action taken against the physician's license, by a state licensing or disciplinary board, or a comparable body in the armed services, including but not limited to limitations of practice, required education, admonishment, reprimand, suspension, or revocation for an act that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (f) An investigation or charge brought against the physician by a licensing or disciplinary body or comparable body in the armed services; (g) A medical or health professional license for which the physician has applied if the application was withdrawn for reasons that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (h) An investigation or charge brought against the physician by a hospital, related institution, or alternative health care system that would be grounds for action under Health Occupations Article, §14-404, Annotated Code of Maryland; (i) Any limitation or loss in privileges by a hospital, related health care facility, or alternative health care system that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (j) A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for a criminal act; (k) A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for an alcohol or controlled dangerous substance offense, including but not limited to driving while under the influence of alcohol or controlled dangerous substances; (l) An arrest which would provide a basis for investigation or charge which would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (m) A physical or mental condition that currently impairs the physician's ability to practice medicine; and (n) The filing or settling of a medical malpractice action in which the physician is, or has been, named as a defendant within the past 5 years. (2) An applicant shall submit the following additional information: (a) Copies of the complaints, pleadings, and judgments in all malpractice claims if the applicant has had 3 or more claims in the 5 years before the filing of the application for licensure; (b) Copies of all arrests, disciplinary actions, judgments, and final orders which occurred or were issued within the 7 years before submitting the application for licensure for driving while intoxicated, driving while under the influence of a chemical substance or medication, or any license probation, suspension, or revocation; and (c) All medical licensure, certification, and recertification examination results and the dates when these examinations were taken. (3) On forms supplied by the Board, an applicant shall agree to release to the Board relevant information from appropriate individuals, other institutions, and government agencies including, but not limited to, the National Practitioner Data Bank, hospitals, and other licensing bodies. (4) On forms supplied by the Board, an applicant shall allow the Board to release information which is not statutorily protected. (5) During the application process, an applicant for licensure shall have the duty to inform the Board by electronic or first-class mail of any of the circumstances listed in §H(1) and (2) of this regulation within 30 days of the occurrence of or notification about these circumstances. (6) If reasonable questions regarding an applicant's physical, mental, or professional competency have been raised by the information provided on the application, the Board may request additional information regarding the applicant's competency from the chief of staff of a hospital where the applicant has practiced. I. English Language Competency. The applicant shall demonstrate oral and written English language competency as described in Regulation .04D of this chapter. J. Speech Impairment. An applicant wishing to claim speech impairment shall submit documentation of the impairment to the Board as described in Regulation .04E of this chapter. #### Regulation .04 Licensure — Documentation for Initial Licensure. *COMAR 10.32.01.04* A. The applicant shall submit an application on a form supplied by the Board. B. Complete Application. (1) A complete application for initial licensure shall include, but is not limited to, proof of the following through documentation on forms supplied by the Board: (a) Verification of medical education; (b) Written and electronic statements from an authorized official of each of the applicant's accredited training programs which: (i) Summarize the experience and performance of the applicant during training; (ii) Detail all actions taken against the applicant by any training program, hospital, medical board, licensing authority, or court for an act that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (iii) Document specifically whether or not the applicant successfully completed the years of training; (iv) Detail any limitations of privileges during the postgraduate training years; and (v) Detail any physical and mental health problems of the applicant that affected the applicant's ability to practice during the years of postgraduate training; (c) Documentation of successful completion of the examination requirements as described in Regulation .03G of this chapter, including submission of all applicant’s scores sent directly to the Board from the examination authority or authorities. (2) The Board may waive the requirement of §B(1)(b) of this regulation on a case-by-case basis, if the applicant's education or training occurred in countries with which reasonable efforts to obtain the required information have been unsuccessful. (3) If licensure in another state preceded the requirement for ECFMG, the Board may waive the requirement for the ECFMG certificate. (4) A complete application which contains a statement from the applicant listing all: (a) Hospitals, following training, at which the applicant has had privileges during the preceding 5 years; and (b) Disciplinary or adverse actions taken against the applicant by a: (i) Hospital, (ii) Medical board, (iii) Licensing authority, (iv) Court, or (v) Adjudicatory body. (5) A complete application shall include: (a) All application and licensing fees as required in Regulation .12 of this chapter, payable to the Board at the time the application is submitted to the Board; and (b) The applicant's Social Security number which the Board shall use only for evaluation and identification of applicants and licensees, but may not disclose in any other context. C. Additional Requirements. Review of an application for licensure shall include: (1) Verification of licensure from all states where the applicant has ever held a license; (2) Verification of voluntary licensure nonrenewal, or voluntary surrender of license while the applicant was in good standing and not under disciplinary charges or investigation at the time the license was surrendered from states where the applicant no longer holds a license; (3) Information in the data bank of the Federation pertaining to the qualifications of the applicant; (4) Information in the National Practitioner Data Bank including but not limited to the following: (a) Medical malpractice judgments against the applicant; (b) Settlements made by the applicant in medical malpractice actions; (c) Actions taken against the applicant or the applicant's license by state disciplinary or licensing authorities; and (d) Actions taken against the applicant or the applicant's privileges by a hospital or hospital disciplinary authority which result in a loss, limitation, or suspension of privileges for a period greater than 30 days; and (5) If reasonable questions regarding an applicant's physical, mental, or professional competency have been raised by the information provided on the application, original letters of reference from all of the hospitals at which the applicant has had privileges, describing the kind of experience received, the performance of the applicant, and explaining under what circumstances those privileges were limited, revoked, or allowed to lapse. D. English Language Competency. The applicant shall demonstrate oral and written competency in English by any of the following: (1) Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (2) Documentation of graduation from a recognized English-speaking professional school; (3) Documentation of a passing score on the USMLE step 2 Clinical Skills; or (4) Documentation of receiving: (a) A score of at least 26 on the “Speaking Section” of the Internet-Based TOEFL; or (b) A score of Advanced or higher on the OPI. E. Claims of Speech Impairment. (1) Applicants wishing to claim a speech impairment after failing either the TOEFL or the OPI shall submit documentation of this impairment on forms supplied by the Board. (2) Documentation of a speech impairment shall be submitted from a: (a) Licensed physician; and (b) Speech-language pathologist who is currently licensed to practice speech pathology in the United States. (3) Documentation should be submitted with the applicant’s initial application but, in all cases, shall be submitted before the applicant’s second attempt at passing the TOEFL or the OPI. (4) After the second examination, documentation of an impairment may not be submitted or accepted unless there has been an intervening medical/surgical event which has created the impairment. (5) The applicant shall be allowed to claim the impairment only if: (a) This event was reported to the Board before a third examination; and (b) The Board determines that the medical/surgical event did indeed create the impairment. (6) If the applicant has properly claimed and documented a speech impairment, the Board shall accept the documentation if the applicant is able to prove the ability to communicate with allied health personnel and patients. Proof shall include: (a) Documentation from 3 licensed physicians that the applicant can communicate in a professionally competent manner with patients and health care providers; or (b) A hearing before the Board where the applicant is asked to describe the manner in which the applicant would obtain a history and physical examination from a typical patient. F. The certifying or verifying authority shall send all certificates and verifications directly to the Board for applicants. The Board may not accept certificates and verifications sent to, or by, the applicant. G. If any of the documents required under this chapter are in a language other than English, the applicant shall submit the certified translation and bear the expense of translation by a certified translator. H. The Board has designated a 4-month period for acting upon applications as follows: (1) Within 60 days after receipt of an application, the Board or its Executive Director will determine whether an application is complete; (2) If the Board or the Executive Director determines that the application is not complete, the Executive Director or the Executive Director's designee shall send a notice of deficiency to the applicant; (3) Upon receipt of the notice, the applicant shall correct the deficiency within 60 days or other period specified in the notice; (4) If the applicant fails to correct the deficiency within the required period, the application may lapse and the applicant shall be required to submit a new application and pay the required fees. I. Withdrawal of Application. (1) An applicant may not withdraw an application for initial licensure, renewal of a license, or reinstatement of a license without permission of the Board, if: (a) The applicant is currently charged in another jurisdiction with conduct which would be grounds for discipline under the Health Occupations Article, §14-404, Annotated Code of Maryland, if the applicant were licensed in this State; (b) The applicant is under investigation in another jurisdiction for an allegation concerning conduct that would be grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland, if the applicant were licensed in this State; or (c) The Board is investigating the applicant or application or has issued a notice of intent to deny licensure. (2) In determining whether to allow the withdrawal of a licensure application, the Board may consider such factors as the following: (a) Issues of competence or conduct which caused the matter to be investigated; (b) Duty to protect the public in other jurisdictions from duplicative expenditures on investigation of licensure applications; and (c) Truthfulness of the applicant during the application process. J. The Board may accept documentation from the FCVS as evidence of having met some of the requirements of Regulations .03 and .04 of this chapter. #### Regulation .05 Inactive and Emeritus Licensure. *COMAR 10.32.01.05* A. Inactive Status. (1) A licensee in good standing who will not practice medicine in this State may apply for inactive status. (2) A licensee applying for an inactive license shall pay the inactive license fee and any additional charges set by the Board. (3) A licensee may apply for inactive status if the licensee has an unrestricted active license to practice medicine in this State or is within 60 days of the expiration of the licensee’s unrestricted active license. (4) Renewal. (a) An inactive status shall be renewed every 2 years. (b) At the end of 2 years, a licensee with inactive status shall complete the renewal application, and pay the renewal fee, and any charges set by the Board. (c) If the licensee fails to renew their inactive license for any reason, the license will expire. (5) A licensee with an inactive license may not: (a) Practice medicine within Maryland; (b) Prescribe medication within Maryland; or (c) Conduct peer reviews of physicians within Maryland. (6) A licensee on inactive status shall have the duty to inform the Board by [electronic] email or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter within 30 days of the occurrence of or notification about these circumstances. (7) The inactive status of a licensee does not deprive the Board of its authority to institute or continue a disciplinary proceeding against a licensee. (8) To reinstate a license to active status, a licensee on inactive status shall apply for reinstatement on a form supplied by the Board and meet the requirements for reinstatement in Regulation .11 of this chapter, including the continuing medical education requirements. The physician may not practice medicine until the license is reinstated to active status. B. Emeritus Status. (1) A licensee who meets the requirements under §B(3) of this regulation, who will not practice medicine in this State, and who is retired from practicing medicine in this State may apply for emeritus status. (2) A licensee applying for emeritus status shall complete the emeritus application and pay the application fee as set by the Board. (3) A licensee may apply for emeritus status if the licensee: (a) Has practiced medicine in Maryland for at least 10 years; (b) Has an active, unrestricted license to practice medicine in Maryland or is within 60 days of the expiration of an active, unrestricted license; (c) Has never been the subject of disciplinary action that has resulted in revocation or suspension of a medical license in any jurisdiction in which they have been licensed to practice medicine; (d) Is not under investigation by the Board; and (e) Is in good standing. (4) A licensee with emeritus status may not: (a) Practice, offer to practice, or attempt to practice medicine within Maryland; (b) Delegate medical acts within Maryland; (c) Prescribe medication within Maryland; or (d) Conduct peer review of physicians within Maryland. (5) A licensee with emeritus status shall complete the renewal application and pay the emeritus renewal fee and any charges set by the Board every third renewal cycle. (6) A licensee on emeritus status shall have the duty to inform the Board by email or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter, including a change of address, within 30 days of the occurrence of or notification about these circumstances. (7) The emeritus status of a licensee does not deprive the Board of authority to institute or continue a disciplinary proceeding against a licensee. (8) To reinstate a license to active status, a physician whose license is on emeritus status shall apply for reinstatement on a form supplied by the Board and meet the requirements for reinstatement in Regulation .11 of this chapter, including the continuing medical education requirements. The physician may not practice medicine until the license is reinstated to active status. #### Regulation .06 Qualifications for Limited License for Postgraduate Teaching. *COMAR 10.32.01.06* A. Moral Character. The applicant for a limited license for postgraduate teaching shall be of good moral character. B. Age. The applicant for a limited license for postgraduate teaching shall be 18 years old or older. C. Education, Training, and Experience. (1) To meet the education and training requirements, a qualified applicant for a limited license for postgraduate teaching shall have: (a) Graduated from an LCME-accredited medical school or a foreign medical school that is listed in the World Directory of Medical Schools at the time of the applicant's graduation or, for doctors of osteopathy, meet the requirements of Health Occupations Article, §14-307(d)(2), Annotated Code of Maryland; (b) Satisfactorily completed a postgraduate training program which meets the following requirements: (i) The postgraduate training shall have been in the specialty in which the applicant will function as a postgraduate teacher, (ii) The postgraduate training shall have included at least the same number of years of specialty postgraduate training as would be required for certification by that specialty's board in the United States and submit the requirements of both to the Board, and (iii) The applicant shall submit documents both from the United States and, if the applicant's specialty postgraduate training was obtained outside the United States, from each foreign specialty board to the Board; and (c) Passed that specialty's certifying examination in either the country where specialty postgraduate training was obtained or where the applicant is practicing. (2) A qualified postgraduate applicant shall meet the following experience requirements: (a) Be a member in good standing of the specialty board in the country from which the applicant is applying; and (b) Have functioned independently as both an academician and clinician for at least 3 years after the completion of postgraduate specialty training. D. Fees. An applicant for a limited license for postgraduate teaching shall pay the limited license fee for postgraduate teaching and any additional charges set by the Board. E. Additional Requirements for Postgraduate Teaching Licenses. (1) The Board may require additional information which includes, but is not limited to, the following: (a) Letter from the chief of staff of any hospital where the applicant has practiced within the 5 years preceding the application for a postgraduate teaching license, detailing the applicant's competence to practice medicine; (b) Malpractice history; (c) Driving record including, but not limited to, convictions for driving while intoxicated or while under the influence of a chemical substance or medication; (d) Medical licensing examination results; (e) Physical or mental examinations, or both, by a physician or evaluation program for treatment of impaired physicians, or both, chosen by the Board. (2) On forms supplied by the Board, an applicant shall agree to release to the Board information from other institutions and government agencies including, but not limited to, the National Practitioner Data Bank, hospitals, and other licensing bodies. (3) During the application process, an applicant for a limited license for postgraduate teaching shall have the duty to inform the Board by electronic or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter within 30 days of the occurrence of or notification about these circumstances. (4) A teaching institution seeking to obtain limited licenses for their postgraduate teachers shall present the Board with the following information: (a) Detailed evidence of the physician's qualifications and competence including the nature of the physician's proposed responsibilities, reasons for any limitations of those practice responsibilities, and the degree of supervision under which the physician will function, if any; (b) A copy of the relevant sections of the hospital bylaws which detail the requirements for, and mechanism of, supervising physicians; and (c) A copy of the relevant section of the hospital bylaws which detail the requirements for, and mechanism of, supervision of postgraduate physician teachers. (5) An applicant for a postgraduate teaching license shall agree that the applicant will: (a) Only practice within the teaching institutions and programs specified within the application; (b) Practice medicine only in conjunction with the applicant's teaching responsibilities; and (c) Not practice medicine outside the applicant's teaching responsibilities. F. English Language Competency. The applicant shall demonstrate oral and written English language competency as described in Regulation .04D of this chapter. G. Speech Impairment. Applicants wishing to claim speech impairments shall submit documentation of these impairments to the Board as described in Regulation .04E of this chapter. H. Terms and Renewal of Postgraduate Teaching Licenses. (1) The Board shall issue a postgraduate teaching license with a term of 1 year. (2) The Board may renew a limited license for postgraduate teaching only once for a maximum period of 1 year. #### Regulation .07 Setting of Fees. *COMAR 10.32.01.07* All fees, not set by statute, will be set by the Board. A copy of the current fee schedule is set forth in Regulation .12 of this chapter. Fees paid to the Board are nonrefundable. #### Regulation .08 Renewals. *COMAR 10.32.01.08* A. The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. B. A licensee shall renew the license every 2 years. C. At least 1 month before the license expires, the Board shall send to the last known address of record of the licensee, by electronic or first-class mail: (1) A renewal notice that states: (a) The date on which the current license expires; (b) The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the license expires; (c) The amount of the renewal fee and any additional charges set by the Board; and (2) A blank panel data sheet supplied by the Health Care Alternative Dispute Resolution Office. D. If the Board chooses to send renewal notices exclusively by electronic mail, the Board shall send a renewal notice by first-class mail to a licensee on request of the licensee. E. The failure to receive a renewal notice does not excuse a licensee from complying with §B of this regulation. F. Before the expiration date of the license, a licensee applying for renewal shall complete the application for renewal on a form supplied by the Board. G. A licensee shall inform the Board by electronic or first-class mail of any of the circumstances listed in Regulation .03H(1) and (2) of this chapter within 30 days of the occurrence of or notification about these circumstances. H. A licensee applying for renewal shall complete the CME requirements as defined in Regulation .10 of this chapter. I. A licensee applying for renewal shall pay the renewal fee and any additional charges set by the Board. J. After the expiration date of the license, the physician is no longer licensed to practice medicine. K. The Board may impose a fine of up to $50,000 for practicing without a license if a formerly licensed physician: (1) Fails to submit an application and to pay the requisite renewal fee within 60 days of the expiration of the license; or (2) Practices medicine 60 days after the expiration of the license or thereafter. L. A holder of a restricted license to practice osteopathy shall renew the license every year as follows: (1) Submit a renewal form supplied by the Board; and (2) Pay a renewal fee and any additional charges set by the Board. M. A licensee applying for the first renewal shall have completed an orientation program approved by the Board. The Board may defer this requirement for physicians practicing out of State or in cases of individual hardship. #### Regulation .09 Expired Licensure. *COMAR 10.32.01.09* A. A licensee with an expired license may not: (1) Practice medicine within Maryland; (2) Prescribe medicine within Maryland; or (3) Conduct peer review of physicians within Maryland. B. A physician whose license is expired and who wishes to practice medicine in Maryland shall apply for reinstatement on a form supplied by the Board and meet the requirements for reinstatement in Regulation .11 of this chapter, including the continuing medical education requirements. The physician is not licensed to practice medicine until the license is reinstated. #### Regulation .10 Continuing Medical Education. *COMAR 10.32.01.10* A. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Terms Defined. (a) “2-year period” means: (i) For license renewal, the 2 years preceding the expiration of the physician license; or (ii) For license reinstatement, the 2 years preceding the date of the submission of the application for reinstatement of the physician license. (b) “Applicant” means: (i) A licensed physician applying for renewal of the physician license; or (ii) A physician applying for reinstatement of the physician license. B. The Board recognizes and accepts CME activities which serve to maintain, develop, or increase knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession, and are within the basic medical sciences, the disciplines of clinical medicine, and the provision of health care to the public. C. Requirements. (1) In accordance with the requirements specified in §C(2) of this regulation, in a 2-year period, an applicant shall earn at least 50 credit hours of Category I or II CME, with at least 25 of those CME credit hours being Category 1. (2) The Board shall recognize for Category I or II CME credit those activities which meet at least one of the following additional requirements for the activity: (a) Be accredited as Category I or II by the ACCME; (b) Be sponsored by an international, national, or state medical society, and meet the standards adopted by the ACCME; (c) Be an accredited training program and have been attended by the applicant within a 2-year period, on the basis of either of the following: (i) 1 year of full-time service earns 50 CME credit hours; and (ii) Full-time service for a portion of a year earns 1 credit hour per week; and (d) Is a service performed by a Board designee and involves medical record review for the Board and the service is performed without compensation and is credited up to a maximum of 10 credit hours for a 2-year period. D. On the application form for renewal or reinstatement, the applicant shall attest to the fact that the applicant has completed the CME requirement. E. Documentation of CME Credits. (1) The applicant has the affirmative obligation to obtain the requisite documentation of CME attendance and retain this documentation for the succeeding 6 years for possible inspection by the Board. (2) The applicant shall be considered to have met the requirements of §C(1) of this regulation if the applicant: (a) Currently holds an active time-limited certification issued by: (i) A member of the American Board of Medical Specialties; (ii) An American Osteopathic Association Certifying Board; (iii) The Royal College of Physicians and Surgeons of Canada; or (iv) The College of Family Physicians of Canada; and (b) Provides proof of maintenance of a time-limited Board certification that is dated no longer than 5 years prior to the renewal date. (3) The required documentation of attendance at a CME program as described in §C(2)(a) and (b) of this regulation shall be a certificate or other documentation of attendance which shall: (a) Contain at a minimum the: (i) Program title; (ii) Sponsor's name; (iii) Physician's name; (iv) Inclusive date or dates and location of the CME event; (v) CME category designation and the number of designated or prescribed CME credit hours; and (vi) Documented verification of successful completion by stamp, signature, hospital printout, or other official proof; and (b) Demonstrate that the CME activity fell within a 2-year period. (4) The required documentation of attendance at an accredited residency or fellowship as described in §C(2)(c) of this regulation shall be a certificate or other form of documentation which shall contain at the minimum the: (a) Program title; (b) ACGME accredited sponsor's name and location; (c) Physician's name; (d) Inclusive dates of the residency or fellowship; (e) Specialty area of residency or fellowship; and (f) Documented verification of completion by the sponsor. F. The Board shall apply the CME requirement to all renewal and reinstatement applications after the first renewal, or, in the case of an applicant who has never renewed, after initial licensure. #### Regulation .11 Reinstatement Expired, Emeritus, or Inactive Licenses. *COMAR 10.32.01.11* A. A physician who has failed to renew a license by the license expiration date and whose license has been placed on inactive status or whose license has been placed on emeritus status shall apply for reinstatement on a form supplied by the Board in order to resume the practice of medicine in this State. B. A physician applying for reinstatement shall pay a reinstatement fee and any additional charges set by the Board. C. A physician applying for reinstatement shall submit documentation of completing the required number of CME hours for reinstatement as defined in Regulation .10 of this chapter. D. A physician applying for reinstatement may be denied reinstatement subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, for any of the grounds listed in Health Occupations Article, §14-404, Annotated Code of Maryland. E. A physician applying for reinstatement shall provide the Board with a detailed description of activities which have occurred since the last renewal application or, in the case of a physician who has never renewed, since the date when a medical licensure application was submitted to the Board. This description may include, but not necessarily be limited to, the information required under Regulations .03 and .04 of this chapter. F. A physician applying for reinstatement may be required to pass the SPEX or COMVEX-USA examination if the physician: (1) Last passed a medical licensing examination more than 15 years before this application; (2) Has never had specialty board certification or last passed a specialty board certification examination given by a member board of the ABMS or the AOA Bureau of Osteopathic Specialists more than 10 years before this application; (3) Has not had a full, unrestricted medical license in at least one state of the United States or Canada within the 10-year period before this application; or (4) Has not actively practiced clinical medicine in the United States or Canada for at least 7 of the 10 years before this application. G. The physician shall include a statement on the application form for reinstatement agreeing to the above examination requirements. #### Regulation .12 Fees. *COMAR 10.32.01.12* The fees are as follows: A. Application fees. (1) Original physician or osteopath licensure application, American and foreign school graduate ... $310; (2) Conceded eminence application ... $1,090; (3) Physician license fee per month until expiration of initial license ... $20; (4) Physician inactive license ... $218; (5) Postgraduate teaching license ... $300; (6) Physician emeritus license ... $120; B. Renewal fees: (1) Physician biennial license renewal ... $486; (2) Inactive biennial renewal fee ... $218; (3) Physician emeritus renewal fee ... $120; C. Physician reinstatement fee ... $700; D. Other fees: (1) Replacement of license for a name change ... $25; (2) Permit to dispense prescription drugs ... $1,050; (3) Written verification of licensure ... $50; (4) Electronic records ... $45 plus $0.05 per record. #### Regulation .13 Advertising. *COMAR 10.32.01.13* A. A physician may place advertisements. B. An advertisement may not contain: (1) Statements containing misrepresentation of facts; (2) Statements that cannot be verified by the Board for truthfulness; (3) Statements likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts; (4) Statements intended to, or likely to, create false or unjustified expectations of favorable results; (5) Statements specifying a fee for professional service which does not include the cost of all related procedures, services, and products which to a substantial likelihood will be necessary for the completion of the advertised service as it would be understood by an ordinarily prudent person; (6) Statements advertising discounted or free services, examinations, or treatments when there will be an additional charge for any additional services, examinations, or treatments which are performed as a result of and within 72 hours of the initial office visit in response to the advertisement unless the professional services rendered are a result of a bona fide emergency; (7) Statements conveying the impression that the physician could improperly influence any public body, official, corporation, or any person on behalf of a patient; (8) Statements containing representations or implications that in reasonable probability can be expected to cause an ordinary prudent person to misunderstand or be deceived; or (9) Statements containing representations that the physician is willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States. C. A physician who is not board certified as defined in Regulation .02B(9) of this chapter may not use the term “board certified” to describe the physician’s qualifications or make any representation that the physician has received formal recognition as a specialist in any aspect of the practice of medicine. D. A physician who is board certified may not use the term “board certified” to indicate certification or expertise in a specialty or subspecialty area other than that in which the physician is certified by the certifying board. E. An advertisement may represent that a physician subspecializes in an area of medicine if the physician first identifies the physician's specialty. F. This regulation does not prevent a physician from accurately describing a focus of the physician's practice in a field within the scope of the physician's training and board certification. G. A physician shall also be accountable under this regulation if he uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation. H. An advertisement may state a range of prices for specifically described services if reasonable disclosure of all relevant variables and consideration is made. I. The Board shall keep a record of those physicians who have been: (1) Identified by the Board of Physician Quality Assurance as specialists before October 1, 1996; or (2) Certified by the American Board of Medical Specialties and the American Osteopathic Association. #### Regulation .14 Solicitation. *COMAR 10.32.01.14* A. A physician may not engage in solicitation, including in-person, telephone, or direct mail solicitation which: (1) Amounts to fraud, undue influence, intimidation, or overreaching; (2) Contains statements which would be improper under Regulation .13B of this chapter. B. A physician shall also be accountable under this regulation if he uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation. #### Regulation .15 Name under which Licensee May Practice. *COMAR 10.32.01.15* A. A physician shall be licensed to practice only under the name on the license. B. A licensee wishing to change the name under which the licensee practices shall obtain the Board's approval under Regulation .15B and C of this chapter. C. The failure of a licensee to practice under the name on the license shall be considered unprofessional conduct by the Board and grounds for disciplinary action. #### Regulation .16 Replacement Licenses. *COMAR 10.32.01.16* A. The Board shall issue a replacement license or registration card if the original license is lost, destroyed, stolen, or damaged, or if there has been a change of the licensee's name. B. The Board shall require that the following accompany requests for replacement licenses: (1) The proper fee; (2) Any required application forms which are to include the reason for the replacement license request; (3) A passport quality photograph of the licensee, taken within 60 days of the application, affixed to the affidavit form supplied by the Board; and (4) Return of the original license if the license is damaged or a replacement is sought for reasons of a name change. C. If the request for a replacement license results from a change of name, the licensee shall submit a certified copy of the official document (marriage certificate, divorce decree, court order, or other document) indicating the name change, date, and place of change. If the change occurred during naturalization, the applicant shall also include the naturalization number, name and address of the court, and the date of naturalization, as well as the name change. D. The Board shall issue a replacement license which bears the same number and expiration date as the original and shall print “Replacement” and the date of replacement across the front of the license. #### Regulation .17 Initial Licensure by Reciprocity. *COMAR 10.32.01.17* A. Requirements. An applicant for initial licensure by reciprocity shall: (1) Have an active, unrestricted license to practice medicine in another jurisdiction that: (a) At the time the applicant was licensed, had licensure requirements substantially equivalent to the Board’s current licensure requirements as set forth in Regulation .03 of this chapter; and (b) Offers a similar reciprocal licensure process to physicians licensed by the Board; (2) Be in good standing under the laws of every jurisdiction where the individual is licensed; and (3) Submit to a State and national criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland. B. Documentation. An applicant for initial licensure by reciprocity shall submit: (1) An application for reciprocity on a form provided by the Board; (2) The application fee as set by the Board; (3) Evidence of compliance with §A of this regulation; and (4) Any additional documentation set forth in Regulation .04 of this chapter that is needed for the Board to evaluate an application. C. On receipt of the documentation required in §B of this regulation, the Board shall process the application for initial license by reciprocity in an expedited manner. D. The Board may not issue a license if the criminal history records information, pursuant to §A of this regulation, has not been received. E. After a license is issued, the licensee is subject to the Board’s jurisdiction and shall comply with all laws and regulations governing the practice of medicine in the State. ### Chapter 02 — Hearings Before the Board of Physicians **Authority:** Health Occupations Article, §§1-307, 1-402, 1-602—1-604, 1-606, 14-205, 14-317, 14-404, 14-405, 14-405.1, 14-406—14-409, 14-411, 14-505, 14-5A-03, 14-5A-13(d), 14-5A-16, 14-5A-17, 14-5A-17.1, 14-5A-19, 14-5B-03, 14-5B-12(d), 14-5B-13, 14-5B-14, 14-5B-14.1, 14-5B-16, 14-5C-03, 14-5C-14(h), 14-5C-16, 14-5C-17, 14-5C-19, 14-5D-12(d), 14-5D-12(g), 14-5D-13—14-5D-16, 14-5E-03, 14-5E-13(h), 14-5E-15, 14-5E-16, 14-5E-17, 14-5E-19, 14-5F-04, 14-5F-15(e), 14-5F-17, 14-5F-18, 14-5F-23, 14-5F-24, 14-601, 14-606, 15-205(b), 15-307(f), 15-311, 15-312, 15-314, 15-315, 15-316 and 15-403; State Government Article, §§10-206, 10-216, and 10-226; Annotated Code of Maryland **Administrative History:** Effective date: September 30, 1973 **Administrative History:** Regulations .01—.10, Hearing Procedures, repealed effective November 7, 1994 (21:22 Md. R. 1877) **Administrative History:** Regulations .01—.09, Hearing Before the Board of Physician Quality Assurance, adopted effective November 7, 1994 (21:22 Md. R. 1877) **Administrative History:** Regulation .03C amended effective March 22, 1999 (26:6 Md. R. 486) **Administrative History:** Regulation .03E amended effective January 24, 2000 (27:1 Md. R. 76); June 24, 2002 (29:12 Md. R. 927) **Administrative History:** Regulation .04 amended effective August 19, 2002 (29:16 Md. R. 1288) **Administrative History:** Regulation .10 adopted effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Chapter revised effective January 21, 2013 (40:1 Md. R. 20) **Administrative History:** Chapter revised effective March 2, 2015 (42:4 Md. R. 433) **Administrative History:** Regulation .02B amended effective March 17, 2025 (52:5 Md. R. 237) **Administrative History:** Regulation .03F amended effective August 7, 2023 (50:15 Md. R. 682) **Administrative History:** Regulation .10 amended effective August 7, 2023 (50:15 Md. R. 682) **Administrative History:** Regulation .17 adopted effective October 23, 2017 (44:21 Md. R. 983) **Administrative History:** Regulation .18 adopted effective March 17, 2025 (52:5 Md. R. 237) #### Regulation .01 Scope. *COMAR 10.32.02.01* These regulations govern procedures for disciplinary and licensing matters before the Board of Physicians. #### Regulation .02 Definitions. *COMAR 10.32.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative action” means an order issued by the Board for reasons other than the disciplinary grounds under Health Occupations Article, §14-404, Annotated Code of Maryland, and that is not considered a disciplinary action. (2) “Administrative expungement” means the classification of a record by the Board as confidential, not for public release, and removed from the licensee’s public individual profile. (3) “Administrative law judge (ALJ)” means a hearing officer delegated the duty of conducting evidentiary hearings for the Board or disciplinary panel. (4) “Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (5) “Administrative prosecutor” means the attorney assigned from the Office of the Attorney General to prosecute administrative charges. (6) Administrative Reinstatement. (a) “Administrative reinstatement” means the reactivation of an inactive or expired license. (b) “Administrative reinstatement” does not include postdisciplinary reinstatement. (7) “Advisory letter” means a nonpublic letter issued by a disciplinary panel which informs, educates, or admonishes an individual licensed by the Board in regard to the practice of medicine or an allied health profession. (8) “Allied health professional” means an individual who is licensed by the Board under: (a) Health Occupations Article, §§14-5A—14-5F, Annotated Code of Maryland; or (b) Health Occupations Article, Title 15, Annotated Code of Maryland. (9) “Applicant” means an individual who has submitted an application to: (a) The Board for initial licensure, for administrative expungement, or for administrative reinstatement; or (b) Disciplinary panel for postdisciplinary reinstatement. (10) “Board” means the Maryland State Board of Physicians. (11) “Board counsel” means the attorney assigned from the Office of the Attorney General for the purpose of advice on legal matters before the Board or a disciplinary panel. (12) “Cease and desist order” means an order of the Board issued under Health Occupations Article, §14-206(e), Annotated Code of Maryland, prohibiting an individual from practicing medicine without a license or from taking an action for which there are grounds for discipline under Health Occupations Article, §14-404, and which poses a serious risk to the health, safety, and welfare of a patient. (13) “Charging document” means written notification that sets forth the grounds upon which the Board or a disciplinary panel is taking administrative action against the respondent or applicant. (14) Complaint. (a) “Complaint” means an allegation or report that: (i) A Board licensee has committed a prohibited act for which a disciplinary panel can take disciplinary action or impose a fine; (ii) An individual is practicing medicine without a license; or (iii) A licensed physician has acted necessitating a Board action under Health Occupations Article, §14-206(e)(2), Annotated Code of Maryland. (b) “Complaint” includes, but is not limited to, the following: (i) Issuance of a certificate of merit in a malpractice claim; (ii) A report from a hospital or related institution, or an alternative health system, pursuant to Health Occupations Article, §14-413 or 14-414, Annotated Code of Maryland; (iii) A law enforcement report; (iv) A report from another country, state, or jurisdiction or the armed services of the United States; (v) A malpractice insurance report; (vi) A report from another federal or state agency or court in any country, state, or jurisdiction; (vii) Consumer complaints; (viii) Media publications; (ix) Statements on applications for licensure, renewal, or reinstatement; and (x) Other information, from whatever source, which warrants investigation. (15) “Contested case” has the meaning stated in State Government Article, §10-202(d), Annotated Code of Maryland. (16) “Disciplinary panel” means a panel established under Health Occupations Article, §14-401, Annotated Code of Maryland, which: (a) Is composed of 11 Board members; and (b) Addresses: (i) Complaints and disciplinary actions against licensed physicians and allied health professionals; and (ii) Postdisciplinary licensure reinstatements. (17) “Disposition agreement” means a formal nonpublic agreement by which the health care provider agrees to comply with certain conditions and the disciplinary panel stays further investigation or forgoes further action on a matter based on compliance with those conditions. (18) “Final order” means: (a) The final written decision of the Board or disciplinary panel which results from a contested case proceeding or other formal proceeding and which contains findings of fact, conclusions of law, and a disposition which: (i) Denies a license; (ii) Sanctions by reprimand, probation, fine, consent order, suspension, or revocation; (iii) Dismisses charges; (iv) Accepts a surrender of a license; or (v) Denies administrative reinstatement of a license; (b) An order that denies postdisciplinary reinstatement of a license; or (c) An order to cease and desist from the practice of medicine. (19) “Fine” means a monetary penalty. (20) “Imperatively requires” means that an action shall be undertaken pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, as a result of factual contentions which raise a substantial likelihood of risk of serious harm to the public health, safety, or welfare before an evidentiary hearing governed by the Administrative Procedure Act is likely to be completed and result in a final order. (21) Investigation. (a) “Investigation” means the gathering of the information necessary for the Board or a disciplinary panel to determine one or more of the following: (i) Whether there is reasonable cause to charge the respondent with a violation of the Medical Practice Act or another statute which gives a disciplinary panel disciplinary authority; (ii) Whether an applicant is eligible for licensure or administrative reinstatement; (iii) The facts necessary for the Board to issue a declaratory ruling; or (iv) Whether an individual has complied with any disciplinary panel order. (b) “Investigation” includes: (i) A preliminary investigation; and (ii) A full investigation. (22) “Involved medical specialty” means the area of medical specialty whose practitioners, in the disciplinary panel’s opinion: (a) Treat the medical or surgical ailment, symptom, or problem in question; and (b) Would likely be familiar with the risks and benefits of treatments provided for that ailment, symptom, or problem. (23) “Licensure” means permission to engage in a health care profession regulated by the Board. (24) “Medical Practice Act” means Health Occupations Article, §§14-101—14-702, Annotated Code of Maryland. (25) “Peer review” means an evaluation by a physician or physicians with special qualifications to judge the matter at hand, based on professional involvement within the involved medical specialty or specialties, of an act or acts of medical or surgical care, or other acts connected with medical practice, by an applicant or licensee. (26) “Post deprivation hearing” means a disciplinary panel hearing scheduled after the disciplinary panel has issued an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland, and at which the respondent has the opportunity to explain why the disciplinary panel should rescind the order of summary suspension. (27) “Postdisciplinary reinstatement” means: (a) The reactivation of a revoked or suspended license; or (b) The reactivation of a license surrendered while the licensee was under investigation or subject to disciplinary charges. (28) “Predeprivation hearing” means a disciplinary panel hearing at which the respondent has the opportunity to explain why the disciplinary panel should not issue an order for summary suspension pursuant to State Government Article, §10-226(c)(2), Annotated Code of Maryland. (29) “Preliminary investigation” means the initial review of a complaint or application irregularity which is the basis for the decision on whether to assign the case to a disciplinary panel for a full investigation or whether to close the investigation due to lack of jurisdiction or because, even if there were a full investigation, there still would not be a legal or factual basis for the issuance of a charging document. (30) “Prohibited act” means any conduct for which the Board or a disciplinary panel can issue a sanction. (31) “Proposed decision” means the proposed findings of fact and, where required by the delegation order from the Board or a disciplinary panel, the proposed conclusions of law and proposed disposition issued by the administrative law judge. (32) “Public individual profile” means the licensee profile maintained by the Board in accordance with Health Occupations Article, §14-411.1, Annotated Code of Maryland. (33) “Recusal” means disqualification by a Board or disciplinary panel member from participating in a proceeding because of a legal interest or prejudice in the case before the Board or disciplinary panel. (34) “Respondent” means an individual who has been: (a) Given notice to answer allegations concerning violations of a statute over which the Board or a disciplinary panel has jurisdiction; (b) Notified as to a potential summary suspension pursuant to State Government Article, §10-226(c), Annotated Code of Maryland; or (c) Given notice to answer allegations concerning violations of a Board or disciplinary panel order. (35) “Revocation” means the removal of a health care provider’s license to practice a health occupation. (36) “Sanction” means an action by the Board or a disciplinary panel which: (a) Reprimands; (b) Places on probation; (c) Fines; (d) Suspends or revokes a license; (e) Disciplines by a consent order; or (f) Accepts a letter of surrender in lieu of charges or further investigation or prosecution. (37) “Sanctioning guidelines” means guidelines set out in Regulation .10 of this chapter, indicating the minimum and maximum penalty associated with each ground for discipline and mitigating or aggravating circumstances which could result in imposition of a penalty below the minimum or above the maximum. (38) “Show cause” means a demand by letter or order issued by a disciplinary panel, which directs the respondent to: (a) Respond either in writing or by an appearance before the Board or a disciplinary panel; and (b) Present reasons and argument why a particular order should not be entered. (39) “Special qualifications to judge the matter at hand” means those credentials which qualify a peer reviewer as a member of the involved medical specialty in a particular case. (40) “Stay” means the withholding of disciplinary panel action against a health care provider. (41) “Stet” means the act of staying further action in a proceeding, subject to the proceeding being reopened at a later date. (42) “Summary suspension” means a denial for an indefinite period of the right to use a license. (43) “Surrender” means the voluntary relinquishing of a Board license to a disciplinary panel. (44) “Suspension” means a denial of the right to use a license. #### Regulation .03 Prehearing Proceedings. *COMAR 10.32.02.03* A. This regulation applies to: (1) Proceedings under Health Occupations Article, §1-307, 14-405, 14-5A-17(b), 14-5B-14(b), 14-5C-17(b), 14-5D-15, 14-5E-16(b), 14-5F-18(b) or 15-315, Annotated Code of Maryland; and (2) To the extent specifically provided in this regulation, cease and desist orders. B. This regulation does not apply to procedures pursuant to Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), or 14-5F-18(c) or 15-314(b), Annotated Code of Maryland. C. Investigation of Complaints. (1) Designated staff shall undertake a preliminary investigation regarding an allegation of grounds for disciplinary or other action brought to the Board’s attention before the allegation is assigned to a disciplinary panel. (2) A complaint concerning alleged grounds for discipline of a Board licensee shall be assigned to a disciplinary panel which: (a) Shall review a complaint in light of the preliminary investigation; and (b) May direct further investigation, referral for peer review, closure without charges, or closure with an advisory letter. (3) Participation in the complaint review process is not ordinarily a basis for recusal of a disciplinary panel member from further proceedings in the case. (4) Investigative Subpoenas. (a) Except as provided in §C(4)(b) of this regulation, upon the receipt of a timely written request from a psychiatrist who is the subject of a complaint concerning the quality of the psychiatric care provided by that psychiatrist, a quorum of a disciplinary panel shall review a subpoena for mental health records made or held by that psychiatrist before the subpoena is enforced. (b) Section C(4)(a) of this regulation does not apply to: (i) Any subpoena other than an investigative subpoena; (ii) A subpoena issued in response to an investigation opened based upon a patient complaint; (iii) A subpoena issued as a result of a complaint or action by a law enforcement agency; (iv) A subpoena issued as a result of a complaint from a health care professional; (v) A subpoena for records if the executive director or the deputy director determines that there is a reasonable possibility that the records will be destroyed, secreted, lost, or altered if the subpoena is not promptly enforced; or (vi) A subpoena if the executive director or deputy director determines that there is a reasonable possibility of imminent harm to the public health, safety, or welfare, including the health, safety, or welfare of an individual patient. (c) Section C(4)(b) of this regulation does not affect any rights which an individual may have under Health-General Article, Annotated Code of Maryland, to contest a subpoena in court. D. Review by the Peer Reviewers. (1) After being assigned a complaint, a disciplinary panel shall have the matter reviewed by peer reviewers if the complaint concerns an allegation that a physician failed to: (a) Meet the standards of quality medical care; or (b) Keep adequate medical records. (2) The disciplinary panel shall obtain reports from at least two different peer reviewers in each case for each allegation referred for peer review. (3) If one or both peer reviewers conclude that a violation of the standard of care has occurred, the disciplinary panel shall make the final peer review report, consisting of the reports of each individual peer reviewer, available to the respondent for review before the disciplinary panel considers whether to issue charges. The disciplinary panel shall redact the names of the peer reviewers before making the report available under this section. (4) The respondent may provide a written response to the peer review report within 10 business days after the report was sent to the respondent by electronic mail or 13 business days if the report was sent via U.S. postal service. (5) The disciplinary panel shall: (a) Consider both the final peer review report and any written response submitted within the time period specified in §D(4) of this regulation; and (b) Determine whether there is reasonable cause to charge a respondent with failure to meet appropriate standards of quality care. E. Prosecution of Complaint. (1) Except as provided in §E(2) of this regulation, a disciplinary panel may not bring charges against a licensee based solely on events contained in a complaint the disciplinary panel received more than 6 years after: (a) The day the complainant actually discovered the facts that form the basis of the complaint; or (b) The day when a reasonable person exercising due diligence should have discovered the facts that form the basis of the complaint. (2) The prohibition in §E(1) of this regulation does not apply to complaints that are based on any of the following: (a) Criminal convictions; (b) Sexual misconduct; (c) Other boundary violations; (d) Reciprocal actions under Health Occupations Article, §14-404(a)(21), Annotated Code of Maryland; (e) Ongoing substance abuse; (f) Fraudulent concealment of material information; or (g) Acts that occurred while a patient was a minor. (3) After reviewing the completed investigative information and reports, a disciplinary panel shall make its determination to: (a) Close a complaint investigation without charges; (b) Take informal action by issuing a nonpublic advisory letter; (c) Request the respondent to enter into a disposition agreement with the disciplinary panel if the respondent suffers from substance abuse or a physical, mental, or emotional condition which may otherwise jeopardize medical care; (d) Except as provided in §E(1) of this regulation, vote to charge a respondent with a violation of a ground under Health Occupations Article, §14-404, Annotated Code of Maryland, or COMAR 10.32.07, or another statute which gives the Board or disciplinary panel authority; (e) Vote to deny administrative reinstatement; or (f) Accept a surrender on terms acceptable to the disciplinary panel. (4) Summary Suspension. (a) In addition to charging, the disciplinary panel assigned to the complaint may vote to summarily suspend or vote an intent to summarily suspend the license of the respondent pursuant to State Government Article, §10-226(c), Annotated Code of Maryland. (b) A vote to summarily suspend the license of the respondent may be taken before the disciplinary panel charges the respondent. (5) After a vote to take formal action under §E(3)(d) or (e) and (4) of this regulation, the disciplinary panel shall refer the matter to the administrative prosecutor for prosecutorial action. (6) Based upon a review of the case, the prosecutor may refer the matter back to the disciplinary panel for further consideration. (7) If the disciplinary panel issues charges, the disciplinary panel shall serve it upon the respondent by regular mail or hand delivery at the address the respondent maintains for purposes of licensure notice. The disciplinary panel may delegate the issuance and service of the charges to the administrative prosecutor. (8) The disciplinary panel, in the notice of administrative reinstatement, shall provide the respondent with an opportunity to request a hearing within 30 days from receipt of service. (9) Disciplinary Committee for Case Resolution (DCCR). (a) After service of the charging document, the respondent and the complainant shall be offered a meeting with the disciplinary panel that was originally assigned the complaint and which sits as a DCCR. The meeting is a voluntary, informal settlement, proceeding to explore the possibility of a consent order or other resolution of the matter. The proceedings concerning a summary suspension are governed by Regulation .08 of this chapter and do not entail a meeting before a DCCR. (b) If the respondent and the administrative prosecutor each do not agree with the proposed settlement offered by the DCCR, the matter proceeds to a hearing before the Office of Administrative Hearings. (c) Except for the DCCRs consideration of a proposed resolution of a case achieved through the conference with the DCCR, the disciplinary panel, the parties, and the complainant may not make use of any commentary, admissions, facts revealed, or positions taken, including any disposition recommended by the DCCR, in the subsequent stages of the disciplinary proceedings unless the subject matter is available from other sources or is otherwise discovered. The respondent, administrative prosecutor, and complainant are prohibited from revealing this material. (d) The complainant and respondent may attend and participate as authorized by statute. The complainant may be accompanied by Board staff but not by any other person. F. Representation; Parties. (1) The respondent may appear in proper person or be represented by counsel in any matter before a disciplinary panel and during any stage of the disciplinary proceedings. The respondent may be represented only by an attorney admitted to the Maryland Bar or specially admitted to practice law in Maryland under Rule 14 of the Maryland Rules Governing Admissions to the Bar found in the Maryland Rules. (2) The administrative prosecutor shall present evidence and argument at an evidentiary hearing on the charges and arguments before a disciplinary panel in the exceptions process as specified in Regulation .05 of this chapter. (3) The administrative prosecutor is a party to the administrative proceedings: (a) As soon as formal charges are issued; and (b) Until a disciplinary panel’s final decision is issued. (4) The Board or a disciplinary panel is not a party to the proceedings before an administrative law judge. G. The Chair, or the Chair’s designee, of a disciplinary panel assigned the complaint may issue orders necessary to regulate the proceedings under this regulation. #### Regulation .04 Adjudication of Allegations in a Charging Document. *COMAR 10.32.02.04* A. Application. (1) This regulation applies to cases under Health Occupations Article, §§1-307, 14-405, 14-5A-17(b), 14-5B-14(b), 14-5C-17(b), 14-5D-15, 14-5E-16(b), 14-5F-18(b) and 15-315 Annotated Code of Maryland. (2) This regulation does not apply to cases under Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), or 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, or to cease and desist orders issued under Health Occupations Article, §14-206(e), Annotated Code of Maryland. B. Delegation. (1) If the charges are not resolved with the DCCR, the chair of the DCCR shall refer the case to the other disciplinary panel which shall delegate to an administrative law judge responsibility to make: (a) Proposed findings of fact; (b) Proposed findings of fact and proposed conclusions of law; or (c) Proposed findings of fact, proposed conclusions of law, and proposed disposition. (2) If the disciplinary panel has delegated the case to the Office of Administrative Hearings for the issuance of proposed findings of fact only, the following apply: (a) The delegation to the Office of Administrative Hearings is limited to making proposed findings of fact on allegations which are disputed; (b) The disciplinary panel may rescind the delegation if: (i) The parties jointly notify the disciplinary panel prior to the prehearing conference, or the administrative law judge notifies the disciplinary panel prior to the occurrence of the factors set out in State Government Article, §10-205(d)(2), Annotated Code of Maryland, that there are no substantial factual allegations in dispute; (ii) The notification recites the facts which are undisputed; and (iii) The disciplinary panel determines that the facts agreed upon are sufficient to decide the issue; and (c) If a delegation to the Office of Administrative Hearings has been rescinded pursuant to §B(2)(b) of this regulation, the disciplinary panel shall set the case on the disciplinary panel docket for the disciplinary panel to issue conclusions of law and a disposition based on the undisputed material facts, after giving the parties a reasonable opportunity for written and oral argument. (3) If the disciplinary panel has delegated the case to the Office of Administrative Hearings for the issuance of proposed findings of fact and conclusions of law only, the following apply: (a) The delegation to the Office of Administrative Hearings is limited to making proposed findings of fact and conclusions of law on allegations which are disputed; and (b) The disciplinary panel may rescind the delegation if: (i) The parties jointly notify the disciplinary panel prior to the prehearing conference, or the administrative law judge notifies the disciplinary panel prior to the occurrence of the factors set out in State Government Article, §10-205(d)(2), Annotated Code of Maryland, that there are no substantial factual allegations or conclusions of law in dispute; (ii) The notification recites the facts and conclusions of law which are undisputed; and (iii) The disciplinary panel determines that the facts and conclusions of law agreed upon are sufficient to decide the issue. (c) If a delegation to the Office of Administrative Hearings has been rescinded pursuant to §B(3)(b) of this regulation, the disciplinary panel shall set the case on the disciplinary panel docket for the disciplinary panel to issue a disposition based on the undisputed material facts and conclusions of law, after giving the parties a reasonable opportunity for written and oral argument. (4) The disciplinary panel may rescind a delegation to an administrative law judge if prior to the start of the evidentiary hearing: (a) The parties execute a proposed consent order settling all aspects of the case; and (b) The disciplinary panel initially assigned the complaint agrees to that proposed consent order. C. Discovery. (1) Discovery on Request. In addition to any disclosures required by §C(2) or (3) of this regulation, by written request served on the other party and filed with the administrative law judge, a party may require another party to produce, within 15 calendar days, the following: (a) A list of witnesses to be called; and (b) Copies of documents intended to be produced at the hearing. (2) Mandatory Notice of Specific Defenses in Cases Involving the Standard of Quality Care. (a) The respondent shall notify the administrative prosecutor not later than 45 days after the issuance of charges of any statement made to the respondent by the patient which was not recorded in the respondent’s medical record of the patient, and which affected the patient’s course of treatment, including but not limited to: (i) Any refusal of hospitalization or treatment; (ii) Any report of symptoms; (iii) Any report of the effects of medication; (iv) Any report by the patient of consultations or treatment by other health care providers; and (v) Any expressions by the patient of a preference for one course of treatment over another. (b) The respondent shall notify the administrative prosecutor not later than 45 days after the issuance of charges of: (i) Any consultation concerning the patient, formal or informal, with any other health care provider, which is not recorded in the patient’s medical record; or (ii) Any communication with family members of the patient which affected the patient’s course of treatment, and which is not recorded in the patient’s medical record. (c) The notices required by §C(2)(a) and (b) of this regulation shall be in writing and shall state: (i) The name of the declarant or consultant; (ii) The substance of the declaration or consultant report; and (iii) The date on which each communication took place. (d) Unless the respondent has provided the notice required by §C(2) of this regulation, the administrative law judge shall exclude from the hearing any evidence described in §C(2)(a) or (b) of this regulation. (3) Mandatory Discovery. (a) Each party shall provide to the other party not later than 15 days prior to the prehearing conference or 45 days prior to the scheduled hearing, whichever is earlier: (i) The name and curriculum vitae of any expert who will testify at the hearing; and (ii) A detailed written report prepared and signed by the expert summarizing the expert’s testimony, which includes the opinion offered and the factual basis and the reasons underlying the opinion. (b) If the administrative law judge finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the administrative law judge shall exclude from the hearing: (i) The testimony of the expert; and (ii) Any report of the expert. (c) The administrative law judge shall consider and decide arguments concerning the sufficiency of the report at the prehearing conference and may require that the report be timely amended, if insufficient, to allow the opposing party ample opportunity to prepare for hearing. (d) If an expert adopts the written report of the disciplinary panel’s peer reviewer or reviewers, or adopts a sufficiently specific charging document as the expert’s report, that adoption is considered to satisfy the requirements set forth in §C(3) of this regulation. (4) Parties are not entitled to discovery of items except as listed in §C(1), (2), or (3) of this regulation. (5) Subject to §C(7) of this regulation, both parties have a continuing duty to supplement their disclosures of witnesses and documents. (6) Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list subsequent to: (a) The prehearing conference, if scheduled; or (b) If no prehearing conference is scheduled, 15 days prior to the hearing. (7) The prohibition from adding witnesses subsequent to the prehearing conference does not apply to witnesses or documents to be used for impeachment or rebuttal purposes. D. Hearing. (1) Unless the delegation has been rescinded according to §B(2), (3), or (4) of this regulation, the administrative law judge shall conduct an evidentiary hearing governed by the Administrative Procedure Act and COMAR 28.02.01. (2) Evidence otherwise admissible under COMAR 28.02.01 may not be excluded solely on the ground that the evidence is not recited in the charging document. (3) During these proceedings, the administrative law judge shall treat all records except for a charging document as confidential and sealed. (4) Construction. (a) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, §C of this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01. (b) In the event of a conflict between §C of this regulation and COMAR 28.02.01, §C of this regulation shall apply. (5) The administrative law judge shall issue to the disciplinary panel, that delegated the case to the ALJ, a written proposed decision including, where applicable, proposed findings of fact, proposed conclusions of law, and a proposed disposition after the conclusion of the hearing. #### Regulation .05 Disciplinary Panel Exceptions Process and Final Order. *COMAR 10.32.02.05* A. Application. (1) This regulation applies to cases under Health Occupations Article, §§1-307, 14-405, 14-5A-17(b), 14-5B-14(b), 14-5C-17(b), 14-5D-15, 14-5E-16(b), 14-5F-18(b) and 15-315 Annotated Code of Maryland. (2) This regulation does not apply to cases under Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-14(c), 14-5D-14(b), 14-5E-16(f), or 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, or to cease and desist orders issued under Health Occupations Article, §14-206(e), Annotated Code of Maryland. B. Exceptions. (1) Written Exceptions. (a) Any party may file with the disciplinary panel, that delegated the case to an administrative law judge, exceptions to a proposed decision of an administrative law judge within 15 days of its issuance. A party may file a response to any exceptions within 15 days of the date the exceptions are filed. The disciplinary panel may extend the period for filing exceptions and responses. The disciplinary panel may grant a party filing exceptions the opportunity to file a reply to a response within a stated period of time as determined by the disciplinary panel in any specific case. No further exceptions or responses of any kind may be accepted. (b) Format. (i) Written exceptions and responses to exceptions are limited to 15 pages in length, double-spaced and in at least 12-point type, and with margins of at least 1 inch. (ii) Any reply to responses to exceptions is limited to five pages in the same format. (iii) If a party attaches any part of the record to the exceptions, response, or reply, the attached pages are not to be encompassed within the applicable page limit. The disciplinary panel may require the attachment of those parts of the record cited in the exceptions in a form designated by the Board. (c) Exceptions, responses, and replies may refer to the record by citing the exhibit number or the transcript page. (d) The disciplinary panel chair or the disciplinary panel chair’s designee may in each case rule on specific procedural issues with respect to written exceptions. (e) The disciplinary panel may not accept additional evidence through the written exceptions process. (2) Oral Exceptions Hearing. (a) If either party files exceptions, the disciplinary panel shall schedule a hearing, ordinarily 30 days after the receipt of responses to the exceptions, after which the disciplinary panel shall issue an order containing the disciplinary panel’s findings of fact, conclusions of law, and disposition. (b) The presiding disciplinary panel member, usually the disciplinary panel chair, shall: (i) Determine all procedural issues that are governed by this section; (ii) Make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing; and (iii) Ordinarily limit oral presentation by the respondent and the administrative prosecutor to 20 minutes each. (c) The party who filed the first exceptions shall ordinarily proceed first. (3) Additional Evidence. At the oral exceptions hearing, the disciplinary panel may not accept additional evidence unless: (a) Both parties consent to the admission of additional documentary evidence and the disciplinary panel determines that acceptance of the additional evidence would promote the just and efficient completion of the process; or (b) The disciplinary panel determines that either: (i) A compelling reason exists that would create an obvious injustice if the additional documentary evidence were not considered and the evidence can be admitted without compromising the rights of the other party, including the other party’s opportunity to see the proffered evidence in a timely manner or cross-examine the source of the proffered document and present evidence to the contrary; or (ii) The evidence has been timely proffered before the administrative law judge and the administrative law judge abused his or her discretion in refusing to admit the evidence. (4) If the parties do not file exceptions, the disciplinary panel shall consider the record, including the proposed decision of the administrative law judge, and issue its order based on the disciplinary panel’s findings of fact and conclusions of law. (5) A Board staff member who testified at the hearing before the administrative law judge may not be present during disciplinary panel deliberations. C. Board Action. (1) Final Order. The disciplinary panel shall issue a final order within 90 days after the conclusion of: (a) An exceptions hearing; or (b) Other formal disciplinary panel proceedings. (2) Effect of Revocation Order. (a) When a time period is not stated in an order for revocation, the disciplinary panel may not entertain an application for postdisciplinary reinstatement until at least 3 years after the date of the order. (b) A revocation of a license may not be for less than 1 year and may be permanent. (c) The disciplinary panel may not entertain an application for postdisciplinary reinstatement after an order of revocation unless: (i) Any time period stated in the order has expired; (ii) The conditions set out in the order have been fulfilled; (iii) The applicant has filed a formal application and paid the fee; and (iv) The applicant meets all of the requirements for reinstatement set out in COMAR 10.32.01.10. (d) The disciplinary panel that issued the final order revoking or suspending the respondent shall entertain applications for reinstatement pursuant to the procedures and standards of Regulation .06B of this chapter. (3) Tolling. (a) Except as a disciplinary panel order directs otherwise in a specific case, if a licensee subject to probation or suspension fails to renew a license: (i) The failure to renew the license does not remove the suspension or probation from the licensee’s disciplinary record during the period of nonrenewal; (ii) Any condition of probation or condition precedent to terminating a suspension that is dependent on possessing a license is tolled until the probationer or suspended licensee again possesses a license; and (iii) The time period of probation or suspension, if any, is tolled until the probationer or suspended licensee again possesses a license. (b) Section C(3)(a) of this regulation does not: (i) Apply to fines; or (ii) Require the disciplinary panel to reinstate any former licensee. #### Regulation .06 Post Disciplinary Reinstatement of a License. *COMAR 10.32.02.06* A. Postdisciplinary reinstatement after an order of suspension is subject to the following conditions: (1) If an order suspends a license for a certain period of time, the respondent may petition the disciplinary panel that issued the order to suspend for postdisciplinary reinstatement only pursuant to that order; (2) The disciplinary panel may not entertain early termination of the suspension; (3) If termination of a suspension is made contingent on the happening of an event, the respondent shall establish the occurrence of the event to the satisfaction of the disciplinary panel; and (4) If a health care practitioner whose license is suspended fails to renew the suspended license when that license expires, the health care practitioner may petition the disciplinary panel for termination of suspension only after applying for and meeting the requirements for reinstatement set out in COMAR 10.32.01.10. B. Postdisciplinary reinstatement of a revoked or surrendered license is subject to the following conditions: (1) A petitioner for postdisciplinary reinstatement of a revoked or surrendered license shall submit the following: (a) A written application for reinstatement on a form prescribed by the Board; (b) The appropriate fee; (c) Written responses to any questions the disciplinary panel may propose concerning the reasons the license was revoked or surrendered and the petitioner’s current fitness to practice; and (d) Evidence of the completion of continuing medical education credits to the same extent as if the petitioner had been continuously licensed; (2) If a license was revoked or surrendered while the licensee was under investigation or subject to disciplinary charges, the disciplinary panel may not consider the application for postdisciplinary reinstatement unless: (a) If the letter of surrender indicates that the surrender or the revocation order is for a certain length of time, the time period has expired; or (b) If the letter of surrender or revocation order does not indicate a time certain, 3 years have passed since the date of the order; and (c) If the letter of surrender makes reinstatement contingent on certain conditions, those conditions have occurred; (3) The disciplinary panel may grant postdisciplinary reinstatement of a revoked or surrendered license only in accordance with the terms of the order of revocation or the letter of surrender; (4) The disciplinary panel may grant postdisciplinary reinstatement subject to any terms and conditions the disciplinary panel considers appropriate for public safety and the protection of the integrity and reputation of the profession; (5) The disciplinary panel that issued the order to revoke or suspend may convene a reinstatement inquiry panel which: (a) May conduct an informal inquiry which shall include, if requested, an opportunity for the petitioner to have a personal interview with the panel; (b) May consider the petitioner’s history; and (c) May consider presentations from both the petitioner and the administrative prosecutor’s office. (6) The disciplinary panel shall consider the application form, the petitioner’s responses to the written questions, and the supporting documentation and written arguments, if any, submitted by the petitioner and the administrative prosecutor’s office, as well as the reinstatement inquiry panel’s recommendation; (7) The disciplinary panel shall determine in its discretion if postdisciplinary reinstatement is in the interest of the health and welfare of the general public and consistent with the best interest of the profession; and (8) A disciplinary panel decision denying reinstatement may set out when, if ever, a subsequent petition may be submitted. C. The disciplinary panel shall issue a final written order on the postdisciplinary reinstatement application that: (1) Reinstates the license of the petitioner without conditions; (2) Reinstates the license of the petitioner with one or more of the following conditions: (a) Probation; (b) Requirements for supervision; (c) Further review of competence or performance; (d) Limitations on practice; or (e) Other conditions that the disciplinary panel considers necessary; or (3) Denies reinstatement. D. An order granting or denying postdisciplinary reinstatement is an order resulting from formal disciplinary action. E. A petition for postdisciplinary reinstatement may be withdrawn only with the permission of the disciplinary panel. The disciplinary panel may not refund the fee except for extraordinary cause. #### Regulation .07 Proceedings under Health Occupations Article, §§14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), 14-5F-18(c) and 15-314(b), Annotated Code of Maryland. *COMAR 10.32.02.07* A. In this regulation, “health care provider” means an individual who is a: (1) Licensed physician; (2) Licensed respiratory care practitioner; (3) Licensed radiographer; (4) Licensed nuclear medical technologist; (5) Licensed radiation therapist; (6) Licensed radiologist assistant; (7) Licensed polysomnographic technologist; (8) Licensed athletic trainer; (9) Licensed perfusionist; (10) Licensed naturopathic doctor; or (11) Licensed physician assistant. B. Health Occupations Article, §§14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), 14-5F-18(c) and 15-314(b), Annotated Code of Maryland, govern mandatory actions of the suspension or revocation of a license on the filing of certified docket entries, if the health care provider is convicted of or pleads guilty, including by an Alford plea, or a plea of nolo contendere to a crime involving moral turpitude. C. Procedures. (1) The Office of the Attorney General through Board counsel shall provide to the disciplinary panel assigned to the case certified docket entries of the criminal court proceeding and the following documents from the court record: (a) For a conviction, at least: (i) The indictment, information, or other formal statement of the charges; and (ii) Documentation of the verdict and sentencing; and (b) For a plea of guilty, including an Alford plea, or a plea of nolo contendere, at least one of the following: (i) Stipulated statement of facts or statement of facts on the record; (ii) Plea agreement containing agreed facts; (iii) Transcript of plea agreement proceedings; or (iv) Written or transcribed opinion or statement of the judge accepting the plea. (2) When the disciplinary panel determines that documents provided to it indicate that the respondent comes within the language and intent of Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b), 14-5E-16(c), 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, and the disciplinary panel has a basis for finding preliminarily that it applies to the respondent, the disciplinary panel shall vote to issue an order requiring the respondent to show cause why the disciplinary panel should not take action under this section. (3) After the vote to issue the show cause order, the disciplinary panel shall refer the matter to the administrative prosecutor for prosecutorial action. (4) Based upon a review of the case, the prosecutor may refer the matter back to the disciplinary panel for further consideration. D. Service. (1) The disciplinary panel shall serve the respondent by regular mail or hand delivery at the address the respondent maintains for purposes of licensure notice. (2) The disciplinary panel may choose to serve the respondent personally. E. Opportunity to be Heard. (1) The respondent, after service of the show cause order, has 30 days in which to respond. (2) The respondent may show cause in writing on the following issues: (a) Lack of conviction or plea; (b) Whether the crime is one involving moral turpitude; (c) Misidentity of the respondent with the defendant in the criminal matter; and (d) Other relevant issues, if any, other than mitigation. (3) The respondent may also, within 30 days of service of the show cause order, request an opportunity to address the disciplinary panel by a limited evidentiary hearing on the same issues. However, this argument may not be as of right, but is discretionary based on the existence of genuine issues of material fact or law as determined by the disciplinary panel. (4) The presiding disciplinary panel member, usually the disciplinary panel chair, shall determine all procedural issues that are governed by this section, and may impose reasonable time limitations. The presiding disciplinary panel member shall make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing. Ordinarily, the respondent and the administrative prosecutor shall limit their oral presentation to 20 minutes each. The respondent shall proceed first. (5) The presiding disciplinary panel member shall allow for consideration of documents the presiding disciplinary panel member determines relevant and material. The presiding disciplinary panel member may not admit oral testimony or witnesses. (6) Disciplinary panel members may ask questions of any party appearing before the disciplinary panel. F. Representation. (1) The respondent may appear in proper person or be represented by counsel. (2) The administrative prosecutor shall present argument in support of the proposed sanction. G. Burdens of Production and Persuasion. (1) The respondent may argue issues as set out in §E(2) of this regulation and has the burden of producing argument or evidence in response to the show cause order. (2) The administrative prosecutor bears the burden of persuasion by a preponderance of the evidence that the respondent was convicted of or pled guilty or nolo contendere to a crime of moral turpitude. H. Disciplinary Panel Action. (1) After consideration of the respondent’s answer, either in writing or at a hearing, the disciplinary panel shall deliberate and determine whether the crime is a crime involving moral turpitude, and then shall issue an appropriate order. (2) A pending appeal of the conviction or plea does not operate as a bar to the disciplinary panel’s acting under Health Occupations Article, §14-404(b)(1), 14-5A-17(c)(1), 14-5B-14(c)(1), 14-5C-17(c), 14-5D-14(b)(1), 14-5E-16(c), 14-5F-18(c) or 15-314(b), Annotated Code of Maryland. (3) A respondent suspended pursuant to Health Occupations Article, §14-404(b), 14-5A-17(c), 14-5B-14(c), 14-5C-17(c), 14-5D-14(b)(1), 14-5E-16(e), 14-5F-18(c) or 15-314(b), Annotated Code of Maryland, shall be reinstated immediately upon the filing of a certified docket entry that the conviction has been reversed. The reinstatement does not terminate any other disciplinary action or investigation pending against the respondent. #### Regulation .08 Summary Suspension. *COMAR 10.32.02.08* A. State Government Article, §10-226(c), Annotated Code of Maryland, governs consideration of summary suspension of a license. B. Notice of Intent to Summarily Suspend. (1) Based on information gathered during an investigation, the disciplinary panel may determine that there is a substantial likelihood of a risk of serious harm to the public health, safety, or welfare by the health provider, and vote an intent to summarily suspend the license of the respondent. (2) If the disciplinary panel votes an intent to summarily suspend, the Board shall refer the matter to the administrative prosecutor for prosecutorial action. (3) Based upon a review of the case, the prosecutor may refer the matter back to the disciplinary panel for further consideration. (4) Notice to the respondent includes a: (a) Proposed order for summary suspension; and (b) Show cause notice letter providing an opportunity to the respondent to show cause why the order should not be issued. (5) The proposed order for summary suspension includes but is not limited to: (a) The statutory authority upon which the order is based; (b) Notification that the respondent may request a full hearing to appeal the summary suspension, if executed by the disciplinary panel; and (c) Statements of investigatory information which serve as a basis for the order. (6) Service. (a) The disciplinary panel shall serve the respondent: (i) At least 5 calendar days before a predeprivation hearing; and (ii) By regular mail or hand delivery at the address the respondent maintains for purposes of licensure notice. (b) The disciplinary panel may choose to serve the respondent personally. (7) A show cause notice may not be required in extraordinary circumstances. The disciplinary panel, after consultation with the Board’s counsel, may suspend a license without prior notice and opportunity to be heard, if: (a) The disciplinary panel determines that the health, welfare, and safety of the public or the physician imperatively requires immediate suspension; (b) Notice and opportunity to be heard before the action is not feasible; and (c) The respondent is provided with a postdeprivation opportunity to be heard within 15 days by the disciplinary panel, that voted to summarily suspend the license. C. Representation. (1) The respondent may appear in proper person or be represented by counsel in any matter before the disciplinary panel. If represented at an evidentiary hearing, the respondent shall be represented only by an attorney admitted to the Maryland Bar or specially admitted to practice law in Maryland under Rule 14 of the Rules Governing Admission to the Bar found in the Maryland Rules. (2) The administrative prosecutor shall appear in prosecution of the case. D. Predeprivation Hearing Before the Disciplinary Panel. (1) The disciplinary panel, that voted to issue a show cause order, shall hold the predeprivation hearing on whether to summarily suspend the license. The presiding disciplinary panel member shall determine all procedural issues that are governed by this section, and may impose reasonable time limitations. The presiding disciplinary panel member may make any rulings reasonably necessary to facilitate the effective and efficient operation of the hearing, and shall limit the oral presentation by the respondent and the administrative prosecutor to 20 minutes each. The respondent shall proceed first. (2) The presiding disciplinary panel member: (a) Shall allow for consideration of oral presentations and documents considered by the presiding disciplinary panel member to be relevant and material to the proceeding and not unduly repetitious; and (b) May not admit oral testimony or witnesses. (3) The disciplinary panel members may ask any questions of any party appearing before the disciplinary panel. E. If the disciplinary panel proceeds under §B(7) of this regulation, the disciplinary panel shall hold a postdeprivation initial hearing. The disciplinary panel shall conduct the hearing in accordance with §D of this regulation unless the parties waive this hearing and proceed to the summary suspension appeal. F. Burdens of Production and Persuasion. (1) The respondent may present argument in opposition to allegations presented in the proposed order for summary suspension. (2) The administrative prosecutor bears the burden to show by a preponderance of the evidence that the health, welfare, and safety of the public imperatively requires the disciplinary panel to issue an order to suspend the respondent’s license. G. After the predeprivation hearing, the disciplinary panel shall vote to: (1) Order a summary suspension; (2) Deny the summary suspension; (3) Enter any order to which the parties may agree; or (4) Enter any interim order which the circumstances of the case warrant. H. After the postdeprivation hearing, the disciplinary panel shall vote to: (1) Reaffirm the summary suspension; (2) Rescind the summary suspension; (3) Enter any order to which the parties may agree; or (4) Enter any interim order which the circumstances of the case warrant. I. The respondent may demand a full evidentiary hearing on the merits within 10 days of the issuance of a summary suspension order, and the Office of Administrative Hearings shall set a hearing within 30 days of the demand. J. Evidentiary Hearing Before the Administrative Law Judge. (1) The appeal from a summary suspension shall be an evidentiary hearing under the Administrative Procedure Act. (2) After a full evidentiary hearing, the administrative law judge shall issue a proposed decision with findings of fact, conclusions of law and disposition. The administrative prosecutor and respondent may file exceptions in accordance with Regulation .05B of this chapter. If a party files exceptions, unless the exceptions hearing is waived, an exceptions hearing, on the record, shall be held before the disciplinary panel that had not issued the order of summary suspension. After the disciplinary panel issues its final order, the respondent may appeal this decision in accordance with Regulation .12 of this chapter. #### Regulation .09 Sanctioning and Imposition of Fines. *COMAR 10.32.02.09* A. General Application of Sanctioning Guidelines. (1) Sections A and B of this regulation and Regulation .10 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §B of this regulation, for violations of Health Occupations Article, §§14-404(a), 14-504 and 1-302, Annotated Code of Maryland, the disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation. (c) A stayed suspension not meeting the criteria for §A(3)(b) of this regulation is ranked as a reprimand. (d) A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction. (e) The addition of a fine does not change the ranking of the severity of the sanction. (4) The disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking should be used to determine which ground will be used in developing a sanction; and (b) The disciplinary panel may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .10 of this chapter, in order to resolve a pending disciplinary action, the disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the disciplinary panel, the administrative prosecutor, and the licensee. (8) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §B(5) and (6) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (9) If the disciplinary panel imposes a sanction that departs from the sanctioning guidelines set forth in Regulation .10 of this chapter, the disciplinary panel shall state its reasons for doing so in its final decision and order. B. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §B(5) and (6) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires the disciplinary panel or an administrative law judge to make findings of fact with respect to any of these factors. (3) A departure from the sanctioning guidelines set forth in Regulation .10 of this chapter is not a ground for any hearing or appeal of a disciplinary panel action. (4) The existence of one or more of these factors does not impose on the disciplinary panel or an administrative law judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (5) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the disciplinary panel and was cooperative during the disciplinary panel proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (6) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified or destroyed evidence, or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. C. Fines for Unauthorized Practice of Medicine. (1) The Board may impose a fine as provided in §C(3) of this regulation for: (a) Practicing medicine without a license in violation of Health Occupations Article, §14-601, Annotated Code of Maryland; or (b) A violation of an order of cease and desist from practicing medicine without a license. (2) Factors in determining the amount of a fine include, but are not limited to the following: (a) The extent to which the respondent derived any financial benefit from the improper conduct; (b) The willfulness of the improper conduct; (c) The extent of actual or potential public harm caused by the improper conduct; and (d) The deterrent effect of the fine. (3) Range of Fines Imposed. (a) Except as specified in §C(3)(b) of this regulation, the Board may impose fines as follows: (i) For the first violation, not less than $1,000 and not more than $30,000; (ii) For the second violation, not less than $10,000 and not more than $40,000; and (iii) For the third violation, not less than $15,000 and not more than $50,000. (b) If the conduct resulted in harm to any patient, the Board may consider each patient seen to be a separate violation when imposing a fine listed in §C(3)(a) of this regulation. (4) The Board shall pay all monies collected pursuant to this section into the Board’s fund. D. Other Fines. (1) The disciplinary panel shall impose a fine of $100 for a violation of Health Occupations Article, §14-505, Annotated Code of Maryland, and a fine of $100 for a violation of Health Occupations Article, §14-316(f), Annotated Code of Maryland. (2) The disciplinary panel shall pay all monies collected pursuant to §D(1) of this regulation into the Board’s fund. E. Offenses Related to Continuing Medical Education Credits. (1) First Offense of Failure to Document Credits. (a) Except as provided in §E(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the disciplinary panel may impose a civil fine under Health Occupations Article, §14-316(d)(5), 14-5A-13(d)(2), 14-5B-12(d)(2), 14-5D-12(g), or 15-307(f), Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-404, 14-5A-17, 14-5B-14, 14-5D-14, or 15-314, Annotated Code of Maryland. (b) Section E(1)(a) of this regulation does not limit the Board’s or disciplinary panel’s authority to require completion of the missing continuing medical education credits. (2) Willful Falsification. (a) If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate: (i) Health Occupations Article, §14-404(a)(3), 14-5A-17(a)(3), 14-5B-14(a)(3), 14-5C-17(a)(3), 14-5D-14(a)(3), 14-5E-16(a)(3), 14-5F-18(a)(19), or 15-314(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-404(a)(11), 14-5A-17(a)(10), 14-5B-14(a)(10), 14-5C-17(a)(10), 14-5D-14(a)(10), 14-5E-16(a)(10), 14-5F-18(a)(9), or 15-314(a)(11), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-404(a)(36) or 15-314(a)(36), Annotated Code of Maryland. (b) Upon a finding of a violation, the disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-404(a), 14-405.1, 14-5A-17, 14-5B-17, 14-5C-17, 14-5D-14, 14-5E-16, 14-5F-18, 15-314, or 15-316, Annotated Code of Maryland, and the sanctioning guidelines. (3) Licensees Previously Disciplined Under §E(1) or (2) of this Regulation. (a) If a licensee has been previously fined or otherwise disciplined under §E(1) or (2) of this regulation, the disciplinary panel may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate: (i) Health Occupations Article, §14-404(a)(3), 14-5A-17(a)(3), 14-5B-14(a)(3), 14-5C-17(a)(3), 14-5D-14(a)(3), 14-5E-16(a)(3), 14-5F-18(a)(19) or 15-314(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-404(a)(11), 14-5A-17(a)(10), 14-5B-14(a)(10), 14-5C-17(a)(10), 14-5D-14(a)(10), 14-5E-16(a)(10), 14-5F-18(a)(9), or 15-314(a)(11), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-404(a)(36) or 15-314(a)(36), Annotated Code of Maryland. (b) Upon a finding of a violation, the disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-404(a), 14-405.1, 14-5A-17, 14-5B-17, 14-5C-17, 14-5D-14, 14-5E-16, 14-5F-18, 15-314, or 15-316, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense. (c) The disciplinary panel may not apply the sanction described in §E(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits. (4) The disciplinary panel shall pay all monies collected pursuant to this section into the State’s General Fund. F. Payment of Fines. (1) An individual shall pay to the disciplinary panel any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise. (2) Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the disciplinary panel pursuant to this regulation. (3) If an individual fails to pay, in whole or in part, a fine imposed by the disciplinary panel pursuant to this regulation, the disciplinary panel may not restore, reinstate, or renew a license until the fine has been paid in full. (4) In its discretion, the disciplinary panel may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. #### Regulation .10 Sanctioning Guidelines for Physicians. *COMAR 10.32.02.10* A. Subject to provisions of Regulation .09A and B of this chapter, the disciplinary panel may impose sanctions as outlined in §B of this regulation on physicians for violations of Health Occupations Article, §§14-404(a), 14-504, and 1-302, Annotated Code of Maryland. B. Range of Sanctions. #### Regulation .11 Disciplinary Actions and Licensure Denials Assigned to the Board. *COMAR 10.32.02.11* A. This regulation applies to proceedings under Health Occupations Article, §14-205(b)(1)(iii), 14-206(e), 14-307, 14-405, 14-606(a)(4)(ii), 14-5A-17(a), 14-5A-09, 14-5A-23(b), 14-5B-09, 14-5B-14(a), 14-5B-19(b), 14-5C-09, 14-5C-17(a), 14-5C-23(b), 14-5D-08, 14-5D-14(a), 14-5D-18(b), 14-5E-09, 14-5E-16(a), 14-5E-23(b), 14-5F-11, 14-5F-18(a), 14-5F-29(b), 15-313, or 15-403, Annotated Code of Maryland. B. The final decision in the proceedings in this regulation is made by the full Board. C. Denial of Application for Initial License. (1) When an individual files an application for a license with the Board, the applicant shall be investigated to determine whether the Board will: (a) Issue a license; or (b) Deny the application. (2) The Board may vote for the issuance of an intent to deny application for an initial license to practice medicine or an allied health profession for one or any combination of the grounds for denial, including: (a) Failing to meet the minimal qualifications or requirements of licensure; (b) Committing an act or an omission constituting grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland; (c) Failing to complete the application or failing to provide additional information requested by the Board in connection with the application; (d) Submitting false or misleading information in connection with the application; or (e) Failing to cooperate with the Board’s investigation of the application. (3) If the Board votes to issue a notice of an intent to deny an application for an initial license, the notice shall be served upon the applicant by regular mail or hand delivery to an address the applicant identified on the applicant’s application. (4) After service of the notice of intent to deny application for initial license, the applicant shall be offered an informal meeting with a panel of the Board to explore whether the matter can be resolved with a consent order. The administrative prosecutor also may attend the meeting. The panel may recommend a consent order granting a license, denying a license, or granting a license with appropriate terms and conditions including probation. (5) If the applicant and the administrative prosecutor agree with the panel’s proposed resolution, the applicant shall sign a consent order with the proposed resolution, and the Board shall vote on whether to approve the resolution. If the applicant and the administrative prosecutor do not agree with the panel’s proposed resolution, the Board shall delegate the matter to the Office of Administrative Hearings for a contested case hearing. (6) If the matter proceeds to a hearing before the Office of Administrative Hearings, the administrative prosecutor shall present evidence before an administrative law judge in support of the denying the initial licensure application. The applicant shall be given an opportunity to present evidence in support of granting the license. (7) The administrative law judge shall conduct an evidentiary hearing in accordance with: (a) The Administrative Procedure Act; (b) COMAR 28.02.01; and (c) COMAR 10.32.02.04C, which shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01. (8) The administrative law judge shall issue a proposed decision. Within 15 days of the issuance of the proposed decision, the applicant and the administrative prosecutor may file exceptions to the proposed decision with the Board. A response to the exceptions may be filed within 15 days of the filing of the exceptions. (9) If exceptions are filed, the Board shall hold a hearing on the exceptions. The exceptions hearing is based upon evidentiary record established before the Office of Administrative Hearings. (10) The Board shall vote and issue a final decision and order on whether the initial license application is granted or denied. (11) An individual whose application for initial licensure has been denied by a final decision and order by the Board may petition for judicial review of the final decision and order as provided by Health Occupations Article, §14-408(a), Annotated Code of Maryland. D. Unauthorized Practice and Misrepresentation as a Licensed Practitioner. (1) The Board may vote for charges that an individual has practiced medicine or an allied health profession without authorization or that an individual has misrepresented one’s self as a practitioner of medicine or as an allied health professional. (2) If the Board votes to charge an individual for practicing medicine or an allied health care profession without authorization or with misrepresenting one’s self as a practitioner of medicine or as an allied health professional, the notice shall be served upon the respondent by regular mail, certified mail, or hand delivery to the individual. (3) After service of the charges, the respondent shall be offered an informal meeting with a panel of the Board to explore whether the matter can be resolved with a consent order. The administrative prosecutor may attend the meeting. The panel may recommend a consent order. (4) If the respondent and the administrative prosecutor agree with the panel’s proposed resolution, the respondent shall sign a consent order with the proposed resolution, and the Board shall vote on whether to approve the resolution. If the applicant and the administrative prosecutor do not agree with the panel’s proposed resolution, the Board shall delegate the matter to the Office of Administrative Hearings for a contested case hearing. (5) If the matter proceeds to a hearing before the Office of Administrative Hearings, the administrative prosecutor shall present evidence before an administrative law judge to prove the charges. The applicant shall be given an opportunity to present evidence in defense. (6) The administrative law judge shall conduct an evidentiary hearing in accordance with: (a) The Administrative Procedure Act; (b) COMAR 28.02.01; and (c) COMAR 10.32.02.04C which shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01. (7) The administrative law judge shall issue a proposed decision. Within 15 days of the issuance of the proposed decision, the applicant and the administrative prosecutor may file exceptions to the proposed decision with the Board. A response to the exceptions may be filed within 15 days of the filing of the exceptions. (8) If exceptions are filed, the Board shall hold a hearing on the exceptions. The exceptions hearing is based upon evidentiary record established before the Office of Administrative Hearings. (9) The Board shall vote and issue a final decision and order. If the Board determines that the respondent has practiced a health care profession without authorization or misrepresented one’s self as a practitioner of medicine, the Board may fine the respondent as authorized by statute and regulation. (10) An individual who is aggrieved by a final decision and order by the Board may petition for judicial review of the final decision and order as provided by Health Occupations Article, §14-408(a), Annotated Code of Maryland. E. Cease and Desist Orders (1) An initial Board order to cease and desist issued under §14-206(e) of the Medical Practice Act from the unauthorized practice of medicine or from taking any action for which there are grounds for discipline under Health Occupations Article, §14-404, Annotated Code of Maryland, and which pose a serious risk to the health, safety, and welfare of a patient: (a) Is a public document; and (b) Is effective immediately unless the order states otherwise. (2) The Board shall serve the initial order by hand delivery, certified mail, or first-class mail. (3) Challenge. (a) A respondent may challenge the factual or legal basis of the initial order by filing a written opposition within 30 days of its issuance, and may include a request for a hearing. (b) The Board shall consider that opposition and shall provide a hearing if requested. (c) After considering the written opposition and the presentation at the hearing, if any, the Board may issue a final order to rescind, modify, or affirm the cease and desist order. (d) The Board shall serve the final order by hand delivery, certified mail, or first-class mail to the last known address of the respondent. (e) The respondent may seek judicial review of the Board’s final order as provided in the Administrative Procedure Act. (4) Violations of a Cease and Desist Order. (a) The Board may impose a fine as provided in Regulation .09C of this chapter on any individual who violates a cease and desist order. (b) Before imposition of a fine for violation of a cease and desist order, the Board shall give notice of the alleged violation, and an opportunity for a hearing. (c) The hearing may not concern issues: (i) That were not raised under §E(3) of this regulation; or (ii) That were raised under §E(3) of this regulation, but for which the Board did not grant the relief or modification requested. (d) The only issues to be considered at the hearing are: (i) Whether the individual violated the cease and desist order; and (ii) The amount of any fine to be imposed. (e) The Board shall issue a final order stating whether a violation occurred and if so, the amount of the fine. (f) The respondent may seek judicial review of the Board’s final order as provided in the Administrative Procedure Act. (5) Nothing in this regulation prohibits the Board from delegating any hearing to the Office of Administrative Hearings as permitted by State Government Article, §10-205, Annotated Code of Maryland. #### Regulation .12 Judicial Review. *COMAR 10.32.02.12* A. A respondent whose license has been sanctioned by a final order of the disciplinary panel after a contested case proceeding under Health Occupations Article, §14-404, 14-5A-17.1, 14-5B-14.1, 14-5C-17(b), 14-5D-15, 14-5E-17, 14-5F-23, or 15-315(b), Annotated Code of Maryland, may seek judicial review of the disciplinary panel’s decision as provided under Health Occupations Article, §14-408(a), Annotated Code of Maryland. B. An individual whose application for administrative reinstatement has been denied by a final disciplinary panel order after a contested case proceeding under Health Occupations Article, §14-205(a)(1)(iii), 14-5A-17.1, 14-5B-14.1, 14-5C-17(b), 14-5D-15, 14-5E-17, 14-5F-23, or 15-315(b), Annotated Code of Maryland, may appeal the decision as provided under Health Occupations Article, §14-408(a), Annotated Code of Maryland. #### Regulation .13 Recusal in Board or Disciplinary Panel Proceedings. *COMAR 10.32.02.13* A. A Board or disciplinary panel member may not participate in an investigation or a proceeding in which the impartiality of the Board or disciplinary panel member might reasonably be questioned, including but not limited to proceedings and investigations in which the Board or disciplinary panel member has or appears to have: (1) A personal bias or prejudice concerning a party; or (2) Personal knowledge of disputed evidentiary facts concerning a proceeding. B. The recusal shall be stated on the record. C. In a hearing before the Board or disciplinary panel, the parties may waive the recusal. #### Regulation .14 Proposed Orders; Show Cause Hearings. *COMAR 10.32.02.14* A. Nothing in this chapter prohibits the issuance of a charging document with a proposed order which will go into effect if the respondent fails to request a hearing. B. Nothing in this chapter prohibits a disciplinary panel from conducting a show cause hearing to determine if there has been: (1) A violation of probation; (2) A violation of a condition under which any portion of a disciplinary order was stayed; or (3) Any other violation of a Board or disciplinary panel order. C. A disciplinary panel may terminate a show cause hearing if it determines that there are material facts in dispute which cannot reasonably be determined in that venue. The disciplinary panel may then convene an evidentiary hearing or delegate such a hearing to an administrative law judge. #### Regulation .15 Confidentiality. *COMAR 10.32.02.15* A. Except for formal charging documents, notices of intent to deny, or as otherwise provided by law, the proceedings of the Board and the disciplinary panels are confidential, and the confidentiality of the proceedings cannot be waived by the parties. B. The recommended decision by an administrative law judge is confidential, and the respondent cannot waive the confidentiality of the contested case proceedings or of the patients whose care is reflected in the record of the proceedings. C. To the extent possible, even after a final order is entered by the Board or a disciplinary panel, the parties shall refrain from revealing legal documents or oral statements or information that would reveal the identity of any patients referenced in the order. #### Regulation .16 Ethics. *COMAR 10.32.02.16* The Board and the disciplinary panels may consider the Principles of Ethics of the American Medical Association, but these principles are not binding on the Board or the disciplinary panels. #### Regulation .17 Opioid Guidelines. *COMAR 10.32.02.17* The Board and the disciplinary panels may consider the “Guideline for Prescribing Opioids for Chronic Pain” published by the Centers for Disease Control and Prevention, but this guideline is not binding on the Board or the disciplinary panels. #### Regulation .18 Administrative Expungement. *COMAR 10.32.02.18* A. Administrative Expungements. (1) The Applicant may file with the Board an application for administrative expungement to have records of an administrative action by a disciplinary panel classified as confidential, not for public release, and removed from the licensee’s public individual profile, if: (a) The application is submitted more than 3 years after the imposition of an administrative action by the Board or after administrative reinstatement or termination of suspension of the license, whichever is later; (b) The licensee had no incidents of a public sanction since the administrative action identified in the application occurred; and (c) The licensee is not currently under probation or investigation by the Board. (2) An application for administrative expungement shall only be granted for the following administrative actions: (a) Failure to pay taxes or unemployment insurance contributions under Health Occupations Article, §1-213(b), Annotated Code of Maryland; (b) Failure to complete continuing medical education requirements under Health Occupations Article, §14-316(d), Annotated Code of Maryland; (c) Failure to renew a license on time under Health Occupations Article, §14-606(a)(5), Annotated Code of Maryland; or (d) Failure to notify the Board in writing of change of name or address within the time required under Health Occupations Article, §14-316(f). (3) An administrative expungement shall not be considered for any license denials, reprimands, probations, suspensions, and revocations issued pursuant to Health Occupations Article, §14-404, Annotated Code of Maryland. B. Application for Administrative Expungement. (1) The application for administrative expungement shall be filed in writing on a form provided by the Board. (2) The application fee shall be $450. (3) The application fee is non-refundable. C. Disposition of Application. (1) If the applicant meets the requirements specified in §§A and B of this regulation, the Board shall inform the applicant when to expect the records to be removed from the applicant’s public practitioner profile as required in Health Occupations Article, §14-411.1, Annotated Code of Maryland, and when all Board records will be classified confidential. (2) If the applicant does not meet the requirements specified in §§A and B of this regulation, the applicant will be deemed ineligible and the Board shall notify the applicant in writing. (3) An applicant whose application is ineligible under §C(2) of this regulation may reapply when they meet the criteria. D. The Board is not required to report an administrative expungement to any national database. E. Nothing in this regulation shall prohibit the Board from using a Board record, previous sanction, or disciplinary action for any regulatory purpose or from releasing records to law enforcement or other governmental body as permitted by law. ### Chapter 03 — Physician Assistant **Authority:** Health Occupations Article, §§1-213, 1-606, 14-205, 15-101—15-502, Annotated Code of Maryland **Administrative History:** Effective date: May 28, 1975 (2:12 Md. R. 870) **Administrative History:** Chapter revised effective October 26, 1981 (8:21 Md. R. 1708) **Administrative History:** Regulations .02 and .05F amended effective September 27, 1982 (9:19 Md. R. 1895) **Administrative History:** Regulations .05B-1 and .09A-1 adopted effective September 27, 1982 (9:19 Md. R. 1895) **Administrative History:** Regulations .01—.11 repealed effective March 18, 1991 (18:5 Md. R. 594) **Administrative History:** Regulations .01—.12 adopted effective March 18, 1991 (18:5 Md. R. 594) **Administrative History:** Regulations .02, .03, .06, .10, and .11 amended; Regulations .07—.09 and .12 repealed; and new Regulations .07—.09, .12, and .15 adopted as an emergency provision effective August 12, 1999 (26:18 Md. R. 1369); amended permanently effective January 24, 2000 (27:1 Md. R. 76) **Administrative History:** Regulations .02 and .05—.07 amended and new Regulation .06-1 adopted as an emergency provision effective November 8, 1996 (23:24 Md. R. 1676); emergency status expired October 1, 1997 **Administrative History:** Regulation .02B amended effective October 2, 1997 (24:17 Md. R. 1214); July 12, 1999 (26:14 Md. R. 1082) **Administrative History:** Regulation .04B amended effective July 12, 1999 (26:14 Md. R. 1082) **Administrative History:** Regulation .05B amended effective October 2, 1997 (24:17 Md. R. 1214) **Administrative History:** Regulation .06C amended effective November 22, 1993 (20:23 Md. R. 1804); October 2, 1997 (24:17 Md. R. 1214) **Administrative History:** Regulation .06D adopted effective October 2, 1997 (24:17 Md. R. 1214) **Administrative History:** Regulation .07A amended effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Regulation .07C adopted effective October 2, 1997 (24:17 Md. R. 1214) **Administrative History:** Regulation .11B amended effective April 25, 1994 (21:8 Md. R. 673) **Administrative History:** Regulation .13 adopted effective July 12, 1999 (26:14 Md. R. 1082) **Administrative History:** Regulation .14 adopted effective July 12, 1999 (26:14 Md. R. 1082) **Administrative History:** Chapter revised effective May 1, 2004 (31:7 Md. R. 584) **Administrative History:** Regulation .06D adopted as an emergency provision effective October 1, 2006 (33:24 Md. R. 1905); adopted permanently effective January 15, 2007 (34:1 Md. R. 32) **Administrative History:** Regulation .08C amended as an emergency provision effective October 1, 2006 (33:24 Md. R. 1905); amended permanently effective January 15, 2007 (34:1 Md. R. 32) **Administrative History:** Regulation .09C amended as an emergency provision effective October 1, 2006 (33:24 Md. R. 1905); amended permanently effective January 15, 2007 (34:1 Md. R. 32) **Administrative History:** Chapter revised as an emergency provision effective August 18, 2011 (38:19 Md. R. 1146); revised permanently effective October 3, 2011 (38:20 Md. R. 1202) **Administrative History:** Regulation .05C amended effective January 18, 2016 (43:1 Md. R. 14) **Administrative History:** Regulation .05F adopted effective November 7, 2016 (43:22 Md. R. 1221) **Administrative History:** Regulation .07 amended effective January 18, 2016 (43:1 Md. R. 14) **Administrative History:** Regulation .07A amended effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .09 amended effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .09E adopted as an emergency provision effective January 4, 2022 (49:4 Md. R. 299); emergency status expired effective July 3, 2022 **Administrative History:** Regulation .17 adopted effective July 22, 2013 (40:14 Md. R. 1175) **Administrative History:** Regulation .18 adopted effective July 22, 2013 (40:14 Md. R. 1175) **Administrative History:** Chapter revised effective January 5, 2026 (52:26 Md. R. 1309) **Administrative History:** Annotation: COMAR 10.32.03 cited in Attorney General Opinion No. 86-008 (February 18, 1986) #### Regulation .01 Scope. *COMAR 10.32.03.01* A. This chapter governs the practice of physician assistants and collaboration between physician assistants and one or more patient care team physicians. B. This chapter does not prohibit: (1) A student from performing any of the procedures described in these regulations as part of an accredited school's clinical curriculum; (2) An individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland; or (3) A physician assistant employed by the federal government from performing duties incident to that employment. #### Regulation .02 Definitions. *COMAR 10.32.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited” means accredited by the Accreditation Review Commission on Education for the Physician Assistant or its successor. (2) “Advanced duties” means medical acts that require additional education, training, or experience that is beyond the physician assistant education program required for licensure. (3) “Ambulatory surgical facility” means a facility: (a) Accredited by: (i) The American Association for Accreditation of Ambulatory Surgical Facilities; (ii) The Accreditation Association for Ambulatory Health Care; or (iii) The Joint Commission on the Accreditation of Health Care Organizations; or (b) Certified to participate in the Medicare Program, as enacted by Title XVIII of the Social Security Act. (4) “Applicant” means an individual who applies to the State Board of Physicians for licensure as a physician assistant. (5) “Board” means the State Board of Physicians. (6) “Category I hours” means hours of continuing medical education given in formally organized programs pertinent to the practice of physician assistant duties, accredited by the American Academy of Physician Assistants, the American Academy of Family Physicians, the Accreditation Council on Continuing Medical Education, the Medical and Chirurgical Faculty of Maryland, or equivalent certifying bodies. (7) “Collaborating physician” means one or more patient care team physicians who collaborate with a physician assistant under a collaboration agreement. (8) Collaboration. (a) “Collaboration” means the communication and decision-making process among health care providers who are members of a patient care team related to the treatment of a patient which includes the degree of cooperation necessary to provide treatment and care to the patient. (b) “Collaboration” includes: (i) Communication of data and information about the treatment and care of a patient, including the exchange of clinical observations and assessments; and (ii) The development of an appropriate plan of care including decisions regarding the health care provided, accessing and assessing appropriate additional resources, expertise, referrals, testing, or studies. (c) “Collaboration” does not require constant, physical presence of a collaborating physician on-site in the practice setting provided that the collaborating physician is accessible by electronic means. (9) “Collaboration agreement” means a document that outlines the relationship between a physician assistant and an individual physician or a group of physicians which is maintained at the practice level and is developed between a physician assistant and collaborating physician or physicians. (10) “Committee” means the Physician Assistant Advisory Committee. (11) “Controlled dangerous substances” means any drug listed as such in Criminal Law Article, Annotated Code of Maryland. (12) “Core duties” means medical acts that are included in the standard curricula of accredited physician assistant education programs. (13) “Correctional facility” means a State or local correctional facility. (14) “Detention center” means a State or local detention center. (15) “Drug sample” means a unit of a prescription drug that is intended to promote the sale of the drug and is not intended for sale. (16) “English-speaking professional school” means a school: (a) That offers a degree after graduation from high school; (b) That is in the United States, its territories and possessions, or the British Commonwealth; and (c) Where all academic and clinical courses are taught in English. (17) “Exempt facility” means: (a) A hospital; (b) An ambulatory surgical facility; (c) A federally qualified health center as defined in Health-General Article, §24-1301(b), Annotated Code of Maryland; or (d) Any other practice setting listed on a hospital delineation of privileges document. (18) “Hospital” means: (a) A hospital as defined under Health-General Article, §19-301(g), Annotated Code of Maryland; (b) A comprehensive care facility that: (i) Meets the requirements of a hospital-based skilled nursing facility under 42 U.S.C. §1395i-3; and (ii) Offers acute care in the same building; and (c) An emergency room that is physically connected to a hospital or a freestanding medical facility that is licensed under Health-General Article, Title 19, Subtitle 3A, Annotated Code of Maryland. (19) “Joint Commission” means the organization formerly known as the Joint Commission on Accreditation of Health Care Organizations. (20) “NCCPA” means the National Commission on Certification of Physician Assistants, Inc. (21) “On-site” means the physical presence of the collaborating physician on the premises of the facility where the physician assistant performs delegated medical acts. (22) “Patient care team” means a multidisciplinary team of health care providers actively functioning as a unit with the leadership of one or more patient care team physicians for the purpose of providing and delivering health care to a patient or group of patients. (23) “Patient care team physician” means a licensed physician who regularly practices in the State and who provides leadership in the care of patients as part of a patient care team. (24) “Physician” means an individual who is licensed by the Board to practice medicine. (25) “Physician assistant” means an individual who is licensed by the Board to practice as a physician assistant. (26) “Prescriptive authority” means the authority of a physician assistant to: (a) Prescribe and administer: (i) Controlled dangerous substances; (ii) Prescription drugs; and (iii) Medical devices; (b) Give verbal, written, or electronic orders for medications; and (c) Dispense starter dosages or drug samples. (27) “Public health facility” means a site where clinical public health services are rendered under the auspices of the Department, a local health department in a county, or the Baltimore City Health Department. (28) “Starter dosage” means an amount of a drug sufficient to begin therapy: (a) Of short duration of 72 hours or less; or (b) Before obtaining a larger quantity of the drug to complete therapy. (29) “Training” means the education or on-the-job training a physician assistant: (a) Receives after initial licensure as a physician assistant; and (b) Requires to perform advanced duties. #### Regulation .03 Physician Assistant Advisory Committee. *COMAR 10.32.03.03* A. Composition. The Physician Assistant Advisory Committee shall be composed as required under Health Occupations Article, §15-202, Annotated Code of Maryland. B. Tenure. (1) The term of a member is 3 years. (2) The initial terms of the members are staggered. (3) At the end of a term, a member continues to serve until a successor is appointed. (4) An individual may be reappointed for a second term but an individual may not serve more than two consecutive terms. C. Vacancy. If a vacancy occurs for a physician or physician assistant, the Board shall appoint a new member in the same category. D. Officers. A Committee chairperson shall be elected every 2 years by a majority vote of the membership of the Committee. E. Removal. Upon the recommendation of the chairman, the Board, by a majority, may vote to remove any member of the Committee for: (1) Neglect of duty, including but not limited to: (a) Failure to attend two successive committee meetings without adequate reason; (b) Failure to attend Board mandated training; or (c) Failure to complete necessary ethics filing requirements; (2) Malfeasance; (3) Misfeasance; (4) Misconduct; or (5) Incompetency. F. The Committee shall: (1) Upon request, review selected applications for licensure, renewal, or reinstatement of physician assistants and make recommendations to the Board as to what action to take on the applications; (2) Review each advanced duty which requires prior approval by the Board and, as needed, interview each physician assistant and one or more patient care team physicians to make recommendations to the Board; (3) Make recommendations to the Board regarding regulations governing physician assistants; and (4) Advise the Board on matters related to the practice of physician assistants. G. The Committee may delegate a physician member and a physician assistant member of the Committee to conduct the interview of each physician assistant and patient care team physician, as permitted under §F(2) of this regulation. #### Regulation .04 Scope of Practice. *COMAR 10.32.03.04* A. Except as otherwise provided under Health Occupations Article, Title 15, Annotated Code of Maryland, an individual shall be licensed by the Board and notify the Board of an executed collaboration agreement before the individual may practice as a physician assistant or collaborate with a patient care team physician. B. A physician assistant's scope of practice will be limited to medical acts that are: (1) Appropriate to the education, training, and experience of the physician assistant; (2) Customary to the practice of a patient care team physician; and (3) Performed in a manner consistent with the collaboration agreement. C. A physician assistant may delegate technical medical acts authorized under Health Occupations Article, §14-306, Annotated Code of Maryland and COMAR 10.32.12 provided the physician assistant: (1) Has notified the Board, in a manner approved by the Board of an executed collaboration agreement; and (2) Has completed at least 7,000 hours of clinical practice experience. D. Prohibitions. (1) Regardless of the setting or other factors, a patient care team physician may not delegate, and a physician assistant may not perform general anesthesia or neuraxial anesthesia, including spinal, epidural, and image-guided interventional spine procedures. (2) Except in hospitals, detention centers, correctional facilities, and public health facilities, a patient care team physician may not collaborate with more than eight physician assistants during the same shift. #### Regulation .05 Qualifications for Licensure as a Physician Assistant. *COMAR 10.32.03.05* A. Application. Applicants shall: (1) Complete an application on a form approved by the Board; (2) Pay an application fee as defined in Regulation .16 of this chapter; (3) Be at least 18 years old; (4) Be of good moral character; and (5) Demonstrate oral and written competency in English by one or more of the following: (a) Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Graduation from a recognized English-speaking professional school; or (c) Receiving a grade of: (i) At least 26 on the Speaking Section of the Internet-based Test of English as a Foreign Language; and (ii) At least 79 on the Internet-based Test of English as a Foreign Language. B. Education. (1) An applicant who has successfully completed an educational program for physician assistants shall: (a) Have graduated from a physician assistant program accredited by The Accreditation Review Commission on Education for the Physician Assistant (ARC-PA), its predecessor, or its successor; and (b) Have passed the physician assistant national certifying examination administered by the National Commission on Certification of Physician Assistants (NCCPA) or its successor. (2) In addition to the requirement specified in §B(1) of this regulation, an applicant who has successfully completed an educational program for physician assistants after October 1st, 2003, shall have one of the following: (a) A bachelor’s degree; or (b) At least 120 credit hours of education at the college or university level. C. Primary Source Verification. The Board may accept the Federation Credential Verification Service for primary source verification of a physician assistant's education and examination. #### Regulation .06 Collaboration Agreements—Core Duties. *COMAR 10.32.03.06* A. Before a physician assistant may perform medical acts, the physician assistant shall: (1) Execute a collaboration agreement between the physician assistant and one or more patient care team physicians; (2) Notify the Board in a manner approved by the Board of the executed collaboration agreement; and (3) Maintain a copy of the executed collaboration agreement on file at the physician assistant’s primary practice location. B. Collaboration Agreement Requirements. (1) A collaboration agreement may only consist of one physician assistant and one or more patient care team physicians practicing at the same facility. (2) A physician assistant shall have a separate collaboration agreement for each of the physician assistant’s employers. (3) The physician assistant has the affirmative obligation to retain the collaboration agreement and all of the documentation pertaining to the collaboration agreement for 5 years after termination of the collaboration agreement for Board inspection. C. Contents. (1) The collaboration agreement shall include, at minimum: (a) Each patient care team physician’s name and Maryland license number; (b) A description of each patient care team physician’s qualifications to collaborate with a physician assistant; (c) The practice specialty of each listed patient care team physician; (d) The physician assistant’s name and Maryland license number; (e) The primary location and settings where the physician assistant will practice; (f) The employer of the physician assistant; (g) A description of the settings where the physician assistant will practice; (h) Any delegation of prescriptive authority and, if applicable, dispensing according to Regulation .08 of this chapter; and (i) Any other information deemed necessary by the Board to carry out the provisions of Health Occupations Article, Title 15, Annotated Code of Maryland. (2) The collaboration agreement may include a description of any provisions established by the listed patient care team physicians that: (a) Detail the practice of the physician assistant; (b) Limit the physician assistant's scope of practice; or (c) Specify office procedures. D. The physician assistant shall attest that: (1) All medical acts performed by the physician assistant shall be: (a) Appropriate to the education, training, and experience of the physician assistant; (b) Customary to the practice of a patient care team physician listed on the collaboration agreement; and (c) Performed in a manner consistent with the collaboration agreement; and (2) Any performance of an advanced duty in collaboration with a patient care team physician shall be in accordance with Health Occupations Article, §15-302.1, Annotated Code of Maryland. E. Each collaborating physician shall document their official acknowledgment of their understanding and status as a listed patient care team physician on the collaboration agreement with the physician assistant. #### Regulation .07 Collaboration Agreements—Advanced Duties. *COMAR 10.32.03.07* A. A physician assistant that has sufficient education, training, and experience in the performance of an advanced duty, may perform that advanced duty under a collaboration agreement without Board approval if: (1) The physician assistant is practicing at an exempt facility in accordance with Health Occupations Article, §15–302.1, Annotated Code of Maryland and meets the conditions in §A(4) of this regulation; (2) The physician assistant has previously received Board approval to perform the advanced duty; or (3) The physician assistant has at least 7,000 hours of clinical practice experience as attested to by the physician assistant. (4) For a physician assistant practicing at an exempt facility the following shall be met: (a) The patient care team physician listed on the collaboration agreement has been credentialed by the exempt facility as a condition of employment; (b) The physician assistant listed on the collaboration agreement has been credentialed by the exempt facility as a condition of employment; and (c) The advanced duty to be delegated by the patient care team physician to the physician assistant is reviewed and approved in a process approved by the exempt facility before the physician assistant performs the advanced duty. B. Except as provided under §A of this regulation, a physician assistant shall receive Board approval to perform an advanced duty prior to performing the advanced duty. C. A physician assistant performing X-Ray duties in accordance with Health Occupations Article, §14–306(e), Annotated Code of Maryland, shall: (1) Notify the Board of an executed collaboration agreement in a manner approved by the Board; (2) Maintain a copy of the collaboration agreement on file at the practice location; (3) Obtain Board approval for the X-Ray duty as an advanced duty if practicing at a location other than an exempt facility; (4) Perform the X-Ray duty in the medical office of a patient care team physician; and (5) Be limited to nonfluoroscopic X-Ray procedures of the extremities, anterior-posterior and lateral, not including the head. D. In addition to the requirements of §C of this regulation, a physician assistant performing the advanced duty of nonfluoroscopic X-ray procedures using a mini C-arm or similar low-level radiation machine shall be required to present the Board with evidence of completion of a course that includes: (1) Didactic instruction of at least eight hours on the following subject matters: (a) Principles of radiography; (b) Image acquisition; (c) Principles of exposure; (d) Image evaluation; (e) Radiation safety; (f) Equipment overview; and (g) Documentation; and (2) Clinical instruction, which shall: (a) Include anterior-posterior and lateral radiographic studies of extremities, not including the head, on at least 20 separate patients; and (b) Be under the direct supervision of the delegating physician or radiologist. #### Regulation .08 Approval, Disapproval, Ineligible, or Modification of Advanced Duties. *COMAR 10.32.03.08* A. Approvals of Advanced Duties. (1) Documentation demonstrating a physician assistant’s authority to perform an advanced duty under this section shall be maintained at the facility where the physician assistant is performing the advanced duty. (2) The Board may audit and review collaboration agreements kept by the physician assistant at the primary place of business of the licensee at any time. (3) If an advanced duty requires Board approval, the Committee: (a) Shall review the collaboration agreement; (b) May conduct a personal interview of the physician assistant and patient care team physicians; or (c) May recommend to the Board that the collaboration agreement be modified to ensure conformance with the requirements of Health Occupations Article, §§15–302 and 15–302.1, Annotated Code of Maryland. B. Modification or Disapproval of Advanced Duties. (1) The Board may modify or disapprove the performance of advanced duties under a collaboration agreement if the physician assistant does not meet the applicable education, training, and experience requirements to perform the specified advanced duties. (2) If the Board disapproves or modifies a request to perform an advanced duties, the Board shall: (a) Notify the delegating patient care team physician listed in the collaboration agreement and the physician assistant in writing of the particular elements of the advanced duty approval request that were the cause for the modification or denial; (b) Set forth the specific reasons for the modification or denial; and (c) Give the applicant an opportunity to submit an amendment to the advanced duty or request a hearing before the Board. (3) To request a hearing regarding modification or disapproval of advanced duties, the applicant shall make a written request for a hearing within 30 days of the receipt of the notice of modification or disapproval. C. Physician Assistant Deemed Ineligible to Perform an Advanced Duty. (1) A physician assistant who applies to perform an advanced duty may be deemed ineligible to perform an advanced duty if the physician assistant or patient care team physician: (a) Fails to complete the application; (b) Fails to provide additional information requested by the Board in connection with the application; or (c) Submits false or misleading information to the Board in connection with the application. (2) If a physician assistant is deemed ineligible to perform the advanced duty, the Board shall: (a) Give written notice to the applicant; and (b) Set forth the specific reasons for the ineligibility. (3) A physician assistant who is deemed ineligible to perform the advanced duty shall not be authorized to perform the advanced duty except for training purposes under the direct supervision of a patient care team physician listed on the collaboration agreement. D. Individual members of the Board are not civilly liable for actions regarding the approval, modification, or disapproval of an advanced duty under the collaboration agreement described in this regulation. #### Regulation .09 Prescriptive Authority and Dispensing Starter Dosage or Drug Samples. *COMAR 10.32.03.09* A. In order for a patient care team physician to delegate prescriptive authority, the [primary supervising] patient care team physician shall ensure that the collaboration agreement includes: (1) A statement describing whether the physician intends to delegate any of the following: (a) Prescribing of: (i) Controlled dangerous substances; (ii) Prescription drugs; or (iii) Medical devices; (b) Giving verbal, written, or electronic orders for medications; (c) Dispensing starter dosages or drug samples; (2) An attestation that all prescribing activities of the physician assistant will comply with applicable federal and State regulations; (3) An attestation that all medical charts and records will contain a notation of any prescriptions written by a physician assistant; (4) An attestation that all prescriptions dispensed include the physician assistant's name and the patient care team physician’s name, business address, and business telephone number legibly written or printed; (5) An attestation that the physician assistant has: (a) Passed the physician assistant national certification exam administered by the National Commission on the Certification of Physician Assistants, Inc. within the previous 2 years; or (b) Completed 8 Category I hours of pharmacology education within the previous 2 years; and (6) An attestation that the physician assistant has at least one of the following: (a) A bachelor's degree or its equivalent; or (b) 2 years of work experience as a physician assistant. B. Dispensing of Drug Samples and Starter Dosages of Drugs by Physician Assistant. (1) A drug sample or starter dosage shall meet the following criteria before a physician assistant may dispense the drug sample or starter dosage: (a) Package is labeled as required by Health Occupations Article, §12-505, Annotated Code of Maryland; and (b) No charge is made for the drug sample or starter dosage. (2) A physician assistant shall enter an appropriate note in the patient’s medical record. (3) A physician assistant may not delegate dispensing of drug samples or starter dosages. #### Regulation .10 Renewal, Reinstatement, Change in Name or Address, and Continuing Education. *COMAR 10.32.03.10* A. Renewal. (1) The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. (2) An individual who has been licensed by the Board as a physician assistant may renew the license every 2 years on the date specified by the Board by: (a) Completing an application on a form approved by the Board; (b) Paying the required renewal fee as defined in Regulation .16 of this chapter; (c) Attesting to completion of continuing education activities as specified in §D of this regulation; and (d) Meeting any additional requirements set by the Board for renewal of a license. B. Reinstatement. The Board shall reinstate the license of a physician assistant if the physician assistant: (1) Completes an application on a form approved by the Board; (2) Pays the required reinstatement fee as defined in Regulation .16 of this chapter; (3) Submits evidence of completion of continuing education activities as specified in §D of this regulation; and (4) Meets any additional requirements set by the Board for reinstatement of a license. C. Change in Name or Address. (1) A physician assistant shall notify the Board in writing of a change in the physician assistant's name or address within 60 days after the change. (2) If a physician assistant fails to notify the Board within the time required under §C(1) of this regulation, the physician assistant is subject to an administrative penalty of $100. D. Continuing Education. (1) Except as specified in §D(2) of this regulation, in order to renew or reinstate a license under §A or B of this regulation, a physician assistant shall complete at least 50 hours of continuing education consisting of: (a) At least 8 hours of Category 1 education on pharmacology topics earned during the 2-year period preceding: (i) For license renewal, the expiration of the physician assistant license; or (ii) For license reinstatement, the date of the submission of the application for reinstatement; and (b) In addition to the continuing education hours specified in §D(1)(a) of this regulation, at least 42 hours of Category I continuing education earned during the 2-year period preceding: (i) For license renewal, the expiration of the physician assistant license; or (ii) For license reinstatement, the date of the submission of the application for reinstatement. (2) A physician assistant who is renewing a license as a physician assistant for the first time since either initial licensure or reinstatement of a license: (a) Shall earn at least 8 hours of Category 1 education on pharmacology topics prior to the expiration of the physician assistant license; and (b) Is not required to complete any other hours of Category I continuing education prior to the expiration of the physician assistant license. (3) Documentation of Continuing Education. (a) A physician assistant shall obtain documentation of attendance at Category I continuing education and retain the documentation for 6 years. (b) The documentation shall contain, at a minimum, the following information: (i) Program title; (ii) Sponsor’s name; (iii) Physician assistant’s name; (iv) Inclusive date or dates and location of the program; (v) Category I designation and the number of continuing education hours earned; and (vi) Documented verification that the physician assistant attended the program by stamp, signature, printout, or other official proof. (c) Proof of maintenance of certification by the National Commission on Certification of Physician Assistants may be used to document compliance with the continuing education requirement. (4) The Board may request a physician assistant to submit evidence of having met the continuing education requirements specified in this regulation. (5) If a physician assistant cannot demonstrate completion of the required continuing education credit hours, the Board may impose a civil penalty of up to $100 per missing continuing education credit hour. #### Regulation .11 Identification as Physician Assistant. *COMAR 10.32.03.11* A. A physician assistant shall: (1) Wear an identification tag or badge which identifies that individual as a physician assistant; (2) Identify himself or herself to all patients as a physician assistant; and (3) Maintain a copy of the physician assistant’s license and collaboration agreement at the practice setting. B. An individual may not identify himself or herself as a physician assistant unless licensed by the Board. #### Regulation .12 Responsibility of the Physician Assistant. *COMAR 10.32.03.12* A. A physician assistant shall: (1) Notify the Board in a manner approved by the Board of an executed collaboration agreement developed by the listed patient care team physician or physicians and the physician assistant; (2) Collaborate with a patient care team physician for medical acts that: (a) Are customary to the practice of a listed patient care team physician; and (b) Are suitable to be performed by the physician assistant, taking into account the physician assistant’s: (i) Education; (ii) Training; and (iii) Experience; (3) Obtain approval for any advanced duties; and; (4) Update the practitioner profile to report the termination of a collaboration agreement for any reason to the Board within 5 days, providing the following information: (a) Name and license number of the patient care team physician and physician assistant; and (b) Reason for termination, including a description of conduct or incident that resulted in the termination. B. Sudden Departure of the Patient Care Team Physician. (1) In the event of the sudden departure, incapacity, or death of a patient care team physician, or in a change in licensure status that results in a patient care team physician being unable to practice medicine in the State, the collaboration agreement will remain active and valid under the supervision of any remaining listed patient care team physicians. (2) If no remaining patient care team physicians are listed on the collaboration agreement, the physician assistant may not practice until the physician assistant has executed a new collaboration agreement and provided notification to the Board. #### Regulation .13 Prohibited Conduct. *COMAR 10.32.03.13* A. The Board may deny a license, reprimand a physician assistant, place a physician assistant on probation, or suspend or revoke a license if the physician assistant: (1) Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or the licensee or for another; (2) Fraudulently or deceptively uses a license; (3) Is guilty of: (a) Immoral conduct in the practice of medicine; or (b) Unprofessional conduct in the practice of medicine; (4) Is professionally, physically, or mentally incompetent; (5) Solicits or advertises in violation of Health Occupations Article, §14-503, Annotated Code of Maryland; (6) Abandons a patient; (7) Is habitually intoxicated; (8) Is addicted to, or habitually abuses, any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; (9) Provides professional services: (a) While under the influence of alcohol; or (b) While using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; (10) Promotes the sale of drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain; (11) Willfully makes or files a false report or record in the practice of medicine; (12) Willfully fails to file or record any medical report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report; (13) On proper request, and in accordance with the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland, fails to provide details of a patient's medical record to the patient, another physician, or hospital; (14) Solicits professional patronage through an agent or other person or profits from the acts of a person who is represented as an agent of the physician assistant; (15) Pays or agrees to pay any sum to any person for bringing or referring a patient or accepts or agrees to accept any sum from any person for bringing or referring a patient; (16) Agrees with a clinical or bioanalytical laboratory to make payments to the laboratory for a test or test series for a patient, unless the licensed physician assistant discloses on the bill to the patient or third-party payor: (a) The name of the laboratory; (b) The amount paid to the laboratory for the test or test series; and (c) The amount of procurement or processing charge of the licensed physician, if any, for each specimen taken; (17) Makes a willful misrepresentation in treatment; (18) Practices medicine with an unauthorized person or aids an unauthorized person in the practice of medicine; (19) Grossly over-utilizes health care services; (20) Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine; (21) Is disciplined by a licensing or disciplinary authority or convicted or disciplined by a court of any state or country or disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under Health Occupations Article, §15-314, Annotated Code of Maryland; (22) Fails to meet appropriate standards as determined by appropriate peer review for the delivery of quality medical and surgical care performed in an outpatient surgical facility, office, hospital, or any other location in this State; (23) Willfully submits false statements to collect fees for which services are not provided; (24) Was subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under this regulation and the licensee: (a) Surrendered the license issued by the state or country to the state or country; or (b) Allowed the license issued by the state or country to expire or lapse; (25) Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (26) Fails to educate a patient being treated for breast cancer of alternative methods of treatment as required by Health-General Article, §20-113, Annotated Code of Maryland; (27) Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes; (28) Fails to comply with the provisions of Health Occupations Article, §12-102, Annotated Code of Maryland; (29) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; (30) Except as to an association that has remained in continuous existence since July 1, 1963: (a) Associates with a pharmacist as a partner or co-owner of a pharmacy for the purpose of operating a pharmacy; (b) Employs a pharmacist for the purpose of operating a pharmacy; or (c) Contracts with a pharmacist for the purpose of operating a pharmacy; (31) Except in an emergency life-threatening situation where it is not feasible or practicable, fails to comply with the Centers for Disease Control and Prevention's guidelines on universal precautions; (32) Fails to display the notice required under Health Occupations Article, §14-415, Annotated Code of Maryland; (33) Fails to cooperate with a lawful investigation conducted by the Board; (34) Is convicted of insurance fraud as defined in Insurance Article, §27-801, Annotated Code of Maryland; (35) Is in breach of a service obligation resulting from the applicant's or licensee's receipt of State or federal funding for the licensee's medical education; (36) Willfully makes a false representation when seeking or making application for licensure or any other application related to the practice of medicine; (37) By corrupt means, threats, or force, intimidates or influences, or attempts to intimidate or influence, for the purpose of causing any person to withhold or change testimony in hearings or proceedings before the Board or those otherwise delegated to the Office of Administrative Hearings; (38) By corrupt means, threats, or force, hinders, prevents, or otherwise delays any person from making information available to the Board in furtherance of any investigation of the Board; (39) Intentionally misrepresents credentials for the purpose of testifying or rendering an expert opinion in hearings or proceedings before the Board, a disciplinary panel, or those otherwise delegated by the Office of Administrative Hearings; (40) Fails to keep adequate medical records; (41) Performs medical acts in a manner that is not consistent with the collaboration agreement; (42) Performs medical acts which are outside the education, training, and experience of the physician assistant; (43) Performs medical acts that are not customary to the practice of the patient care team physicians listed on the collaboration agreement; (44) Practices as a physician assistant without first providing notice to the Board as required under Health Occupations Article, §15–302(A), Annotated Code of Maryland; (45) Fails to complete a criminal history records check under Health Occupations Article, §14–308.1, Annotated Code of Maryland; (46) Fails to comply with the requirements of the Prescription Drug Monitoring Program set forth in Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland; or (47) Fails to comply with any State or federal law or regulation pertaining to the practice of a physician assistant. B. Unprofessional conduct in the practice of medicine, Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland, includes the failure of a physician to comply with the statute and regulations governing the physician's duty to supervise the physician assistant. #### Regulation .14 Reports by Employers and Patient Care Team Physician. *COMAR 10.32.03.14* A. Except as provided in §B of this regulation, a hospital, related institution, alternative health care system, and employer physician shall file with the Board a report that the hospital, related institution, alternative health system, or employer physician limited, reduced, otherwise changed, or terminated any licensee for any reason that might be grounds for disciplinary action under Regulation .13 of this chapter or Health Occupations Article, Titles 14 and 15, Annotated Code of Maryland. B. Exception. A hospital, related institution, alternative health system, or employer that has reason to know that a licensee has committed an action or has a condition that might be grounds for reprimand or probation of the licensee or suspension or revocation of the licensure because the licensee is alcohol impaired or drug impaired is not required to report the licensee to the Board if: (1) The hospital, related institution, alternative health system, or employer knows that the licensee is: (a) In an alcohol or drug treatment program that is accredited by the Joint Commission or is certified by the Maryland Department of Health; or (b) Under the care of a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse; (2) The hospital, related institution, alternative health system, or employer is able to verify that the licensee remains in the treatment program until discharge; and (3) The action or condition of the licensee or holder of a temporary license has not caused injury to any person while the licensee or holder of a temporary license is practicing. C. Notice by Licensee. (1) If the licensee enters, or is considering entering, an alcohol or drug treatment program that is accredited by the Joint Commission or that is certified by the Maryland Department of Health, the licensee shall notify the hospital, related institution, alternative health system, employer, or patient care team physician of the licensee's or holder's decision to enter the treatment program. (2) If the licensee fails to provide the notice required under §C(1) of this regulation, and the hospital, related institution, alternative health system, employer, or patient care team physicians learn that the licensee has entered a treatment program, the hospital, related institution, alternative health system, employer, or patient care team physician shall report to the Board that the licensee has entered a treatment program and has failed to provide the required notice. (3) If the licensee is found to be noncompliant with the treatment program's policies and procedures while in the treatment program, the treatment program shall notify the hospital, related institution, alternative health system, employer, or patient care team physician of the licensee's noncompliance. #### Regulation .15 Examination and Audit of Physician Assistant Practice. *COMAR 10.32.03.15* A. Examination. (1) The Board may direct a physician assistant who is an applicant or licensee to submit to an appropriate examination to determine the physician assistant’s physical, mental, or professional ability to perform delegated medical acts. (2) A physician assistant is deemed to have consented to an examination and waived any claim to privilege as to the examination report. (3) The unreasonable failure or refusal of an applicant or licensee to submit to an examination is: (a) Prima facie evidence that the physician assistant cannot perform delegated medical acts; and (b) Cause for denial of an application or suspension of a license. B. Entry. (1) The executive director of the Board or other authorized representative or investigator may enter at any reasonable hour a place of business of a physician or physician assistant or into public premises: (a) For the purpose of an audit to verify general compliance with the Maryland Physician Assistants Act; or (b) To investigate an allegation with respect to a physician assistant. (2) A person may not deny or interfere with an entry under §B(1) of this regulation. (3) A person who violates any provision of §B(1) of this regulation is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $100. C. Audit. (1) The Board’s representatives may require a physician, physician assistant, or facility where the physician assistant is employed or practicing to provide immediate access to any records relating to the physician assistant’s employment, credentialing, and practice and any medical records of patients seen by the physician assistant. (2) The Board’s representative shall refer possible compliance issues to: (a) The compliance section of the Board; or (b) An outside agency that has jurisdiction over a facility. (3) A physician, physician assistant, or facility who fails to comply with a Board audit in accordance with §C(1) of this regulation is subject to an administrative fine. #### Regulation .16 Practice During a Disaster. *COMAR 10.32.03.16* A. A physician assistant who is licensed in this State or in any other state or who is an employee of the federal government is authorized to perform acts, tasks, or functions as a physician assistant during a disaster within a county in which a state of disaster has been declared by the Governor, or counties contiguous to a county in which a state of disaster has been declared, in accordance with Public Safety Article, §14-107, Annotated Code of Maryland. B. The physician assistant shall notify the Board in writing of their name, practice locations, and telephone numbers for the physician assistant within 30 days of the first performance of medical acts, tasks, or functions as a physician assistant during the disaster. C. A team of physicians and physician assistants or physician assistants practicing under this regulation may not be required to maintain on-site documentation describing collaboration agreements as otherwise required in Regulation .06 of this chapter. #### Regulation .17 Fees. *COMAR 10.32.03.17* The following fees are applicable to physician assistants: A. Application fees: (1) Initial application — $310 (2) Endorsement application — $100 (3) Reciprocity application — $100; and (4) Reinstatement application — $400; B. Physician Assistant license fee per month until expiration of license .—. $10; C. Renewal fees: (1) License renewal fee .—. $360; (2) Maryland Health Care Commission (MHCC) fee ... As determined by MHCC under COMAR 10.25.03; and (3) Preceptor fee — as determined in accordance with Health Occupations Article, §15–206(a)(2)(i), Annotated Code of Maryland; D. Written verification of licensure .—. $25; and E. Advanced Duty Application Fee — $100. #### Regulation .18 Sanctioning and Imposition of Fines. *COMAR 10.32.03.18* A. General Application of Sanctioning Guidelines. (1) Sections A and B of this regulation and Regulation .18A and B of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §B of this regulation, for violations of the sections of the Physician Assistants Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction. (c) The addition of a fine does not change the ranking of the severity of the sanction. (4) The Board may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and (b) The Board may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .18 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the Board, the administrative prosecutor, and the licensee. (8) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §B(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (9) If the Board imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .18 of this chapter, the Board shall state its reasons for doing so in its final decision and order. B. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §B(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. (3) The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (4) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (5) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. (6) A departure from the sanctioning guidelines set forth in Regulation .18 of this chapter is not a ground for any hearing or appeal of a Board action. C. Fines for Unauthorized Practice as a Physician Assistant. (1) The Board may impose a fine not exceeding $5,000 as provided in §C(2) of this regulation for unauthorized practice as a physician assistant in violation of Health Occupations Article, §15-401, Annotated Code of Maryland. (2) Factors in determining the amount of a fine include, but are not limited to the following: (a) The extent to which the respondent derived any financial benefit from the improper conduct; (b) The willfulness of the improper conduct; (c) The extent of actual or potential public harm caused by the improper conduct; and (d) The deterrent effect of the fine. (3) The Board shall pay all monies collected pursuant to §C of this regulation into the Board of Physicians' fund. D. Employment of Unauthorized Individuals. (1) A licensed physician, hospital, related institution, alternative health system, or employer may not employ an individual practicing as a physician assistant who does not have a license. (2) A licensed physician may not supervise an individual practicing as a physician assistant who does not have a license. (3) The Board may impose a fine of up to $1,000 for a violation of §D(1) or (2) of this regulation. (4) Any funds collected under §D(3) of this regulation shall be deposited into the State's General Fund. E. Other Fines. (1) The Board may impose a fine of $100 for a violation of Health Occupations Article, §15-309, Annotated Code of Maryland. (2) The Board shall pay all monies collected pursuant to §E(1) of this regulation into the Board of Physicians' fund. F. Offenses Related to Continuing Medical Education Credits. (1) First Offense of Failure to Document Credits. (a) Except as provided in §F(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §15-307(f), Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §15-314, Annotated Code of Maryland. (b) Section F(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits. (2) Willful Falsification. (a) If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate: (i) Health Occupations Article, §15-314(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §15-314(a)(11), Annotated Code of Maryland; and (iii) Health Occupations Article, §15-314(a)(36), Annotated Code of Maryland. (b) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §15-314 or 15-316, Annotated Code of Maryland, and the sanctioning guidelines. (3) Licensees Previously Disciplined Under §F(1) or (2) of this Regulation. (a) If a licensee has been previously fined or otherwise disciplined under §F(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate: (i) Health Occupations Article, §15-314(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §15-314(a)(11), Annotated Code of Maryland; and (iii) Health Occupations Article, §15-314(a)(36), Annotated Code of Maryland. (b) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §15-314 or 15-316, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense. (c) The Board may not apply the sanction described in §F(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits. (4) The Board shall pay all monies collected pursuant to §F of this regulation into the State's General Fund. G. Payment of Fines. (1) An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise. (2) Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation. (3) If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full. (4) In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. ### Chapter 04 — Delegation of Duties by a Licensed Physician-Psychiatrist to a Psychiatrist's Assistant **Authority:** Health Occupations Article, §§14-205, 14-302, and 14-306, Annotated Code of Maryland **Administrative History:** Effective date: May 24, 1982 (9:10 Md. R. 1022) **Administrative History:** Chapter revised effective May 8, 1995 (22:9 Md. R. 645) **Administrative History:** Regulation .01 amended effective October 10, 2016 (43:20 Md. R. 1110) **Administrative History:** Regulation .05 amended effective October 10, 2016 (43:20 Md. R. 1110) #### Regulation .01 Scope. *COMAR 10.32.04.01* This chapter concerns the registration of psychiatrist's assistants before October 1, 1993, and re-registration and discipline of psychiatrist's assistants currently registered by the Board of Physicians. #### Regulation .02 Definitions. *COMAR 10.32.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means the registered psychiatrist's assistant and supervisory psychiatrist who applied to the Board on or before October 1, 1993, for approval of duties and supervision. (2) “Board” means the Board of Physicians. (3) “Facility” means a: (a) Hospital; (b) Nursing home; (c) Health maintenance organization; (d) Community health center; (e) Public health clinic; (f) Similar institution; or (g) Medical office of more than one psychiatrist. (4) “Psychiatrist” means an individual licensed to practice medicine in Maryland who has completed the psychiatric residency requirements in a program approved by the American Board of Psychiatry and Neurology or who has received, or is eligible for, certification by the American Board of Psychiatry and Neurology. (5) “Psychiatrist's assistant” means an individual who applied for registration on or before October 1, 1993, and was registered by the Board to perform medical duties which would normally be performed by a psychiatrist. #### Regulation .03 Permitted Assignment of Duties. *COMAR 10.32.04.03* A psychiatrist may assign duties which constitute the practice of medicine to a psychiatrist's assistant in accordance with these regulations. #### Regulation .04 Standards for Psychiatrist Supervision of Psychiatrist's Assistants. *COMAR 10.32.04.04* A. The psychiatrist shall personally examine, diagnose, and establish a treatment plan for each patient before assigning a patient to a psychiatrist's assistant. B. Adequate supervision of a psychiatrist's assistant in the performance of medical acts under these regulations requires the personal presence of the psychiatrist or the psychiatrist's participation through telephone contact, chart review, or other means as approved by the Board, or all of the above. C. Adequate supervision does not necessarily require on-site supervision in all cases. D. When in the performance of his medical duties, a psychiatrist's assistant finds a significant, new undiagnosed condition or a significant change in an existing diagnosed illness, the psychiatrist's assistant shall immediately apprise the supervising psychiatrist of the condition or change. The supervising psychiatrist shall then direct appropriate treatment and shall be available to promptly attend the patient. E. A psychiatrist may not employ more than two full-time psychiatrist's assistants in a non institutional practice. #### Regulation .05 Registration and Re-registration. *COMAR 10.32.04.05* A. After October 1, 1993, the Board may not accept or approve any application for registration. B. An individual who has been registered by the Board as a psychiatrist's assistant pursuant to this chapter shall renew the registration every 2 years on the date specified by the Board by re-registration and payment of the appropriate fees. A registrant shall meet all the requirements of this chapter at re-registration. C. A psychiatrist's assistant shall notify the Board in writing of a change in the psychiatrist’s assistant name or address within 60 days after the change. D. Notice of the required re-registration shall be given by the Board to the psychiatrist's assistant at the address as shown on the records of the Board. E. The psychiatrist's assistant shall complete this re-registration by the date specified by the Board. F. If a psychiatrist's assistant does not receive notice of re-registration it shall be the responsibility of the psychiatrist’s assistant to contact the Board in order to complete this re-registration before the expiration of the current registration. G. A psychiatrist's assistant whose registration has expired for failure to renew is unregistered. A registration which has expired shall be considered permanently expired. H. For purposes of the re-registration, appropriate standards for continuing medical education for psychiatrist's assistants may be promulgated by the Board. I. When the registration expires, the approval of duties and supervision becomes invalid. #### Regulation .06 Approval of Duties and Supervision. *COMAR 10.32.04.06* A. When a physician or facility and a psychiatrist's assistant have agreed to the psychiatrist's assistant's employment, the two parties shall provide the Board with a written application for approval of duties and supervision before the psychiatrist's assistant begins his duties. B. A psychiatrist's assistant may not begin employment until a notice of approval of duties and supervision is issued by the Board to the physician or facility and the psychiatrist's assistant. C. Application for Approval of Duties and Supervision. (1) The application shall be made on a form supplied by the Board and shall include: (a) A complete list and description of the duties to be assigned to the psychiatrist's assistant. (b) A detailed description of the supervisory relationship between the psychiatrist and the psychiatrist's assistant or the psychiatrists in a facility and the psychiatrist's assistant. The description of the supervisory relationship shall include a schedule of patient reviews. (2) Facility employers of psychiatrist's assistants shall submit to the Board for approval: (a) The name of a principal psychiatrist who will be responsible for the assigned duties and supervision of all psychiatrist's assistants; (b) The total number of psychiatrist's assistants to be employed. (3) The application shall be signed by the psychiatrist and the psychiatrist's assistant or, if a facility, by the principal psychiatrist and all supervising psychiatrists and the psychiatrist's assistant. D. The Board shall notify the psychiatrist's assistant and the psychiatrist or facility of its approval or disapproval of the duties and supervisory relationship within 60 days of receipt of the notice of employment. E. The Board may approve an application in whole or in part, based upon the applicant's education and experience. F. The Board shall have the authority to review the practice and supervisory relationship of a psychiatrist's assistant and psychiatrist or facility's psychiatrist at any time for conformance with these regulations. #### Regulation .07 Termination of Employment. *COMAR 10.32.04.07* Notice shall be given to the Board by the psychiatrist or the facility and the psychiatrist's assistant within 10 days of termination of employment. #### Regulation .08 Responsibility of the Psychiatrist. *COMAR 10.32.04.08* A. A record of patient reviews with the psychiatrist's assistant shall be kept on file and shall include a summary of the psychiatrist's observations and recommendations. B. A psychiatrist may not assign the ultimate responsibility for diagnosis or therapy to a psychiatrist's assistant. C. Notwithstanding any provision contained in these regulations, a psychiatrist may not assign to a psychiatrist's assistant the duty of independently prescribing or dispensing drugs. #### Regulation .09 Psychiatrist's Responsibility to Patient not to be Limited by Assignment. *COMAR 10.32.04.09* When the Board approves a psychiatrist's assistant's duties and supervisory relationship with a psychiatrist, that approval does not relieve the psychiatrist from the primary responsibility for the care and treatment of the patient. Medical services rendered to a patient by a psychiatrist's assistant shall be, with respect to the obligation of the psychiatrist, the same as if those services had been rendered directly by the psychiatrist. #### Regulation .10 Fees. *COMAR 10.32.04.10* The Board shall establish fees for application, registration, re-registration, late registration, and reinstatement of psychiatrist's assistants. #### Regulation .11 Identification of the Psychiatrist's Assistant. *COMAR 10.32.04.11* A. The psychiatrist's assistant shall wear a tag or badge with lettering clearly visible to the patient, bearing his name and the title “Registered Psychiatrist's Assistant”. The use of any other degree designation either on the badge or in any other phase of practice as a psychiatrist's assistant is prohibited. B. A patient calling or walking in for an appointment shall be clearly notified at that time whether he will be seeing the psychiatrist or the psychiatrist's assistant. C. A psychiatrist's assistant may not represent himself as a psychiatrist's assistant in any employment unless an application for approval of duties and supervision has been approved by the Board. D. The Board shall maintain a registry of psychiatrist's assistants. #### Regulation .12 Hearings Following Denial of Application or Re-Registration. *COMAR 10.32.04.12* A. If the Board disapproves an application for approval of duties and supervision, it shall give notice to the applicant and set forth the specific reasons for the denial. The applicant shall have the right to appear before the Board and be heard. B. If the applicant desires to be heard, he shall make a written request for a hearing within 10 days of the receipt of the notice of disapproval of his application. The hearing shall be held within 60 days after the written request has been filed. C. At the hearing the applicant may be represented by counsel and may present witnesses and other evidence on his behalf. D. The Board shall affirm, reverse, or modify its previous disapproval and give the applicant written notice of the action which it has taken within 30 days after the hearing, unless the applicant agrees to a longer period. #### Regulation .13 Prohibited Conduct, Hearings, and Appeals. *COMAR 10.32.04.13* A. For the commission of a prohibited act, subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, on the affirmative vote of a majority of its full, authorized membership, the Board may: (1) Reprimand any psychiatrist's assistant; (2) Place any psychiatrist's assistant on probation; or (3) Suspend or revoke the registration of a psychiatrist's assistant. B. The following are prohibited acts: (1) Fraudulently or deceptively obtaining, or attempting to obtain, a registration for the applicant or certified individual or for another; (2) Fraudulently or deceptively using a registration; (3) Being guilty of unprofessional or immoral conduct in the practice of psychiatry as a psychiatrist's assistant; (4) Being professionally, physically, or mentally incompetent; (5) Habitually being intoxicated; (6) Being addicted to, or habitually abusing, any narcotic or controlled dangerous substance as defined in Criminal Law Article, Annotated Code of Maryland; (7) Providing professional services while: (a) Under the influence of alcohol, or (b) Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; (8) Willfully making or filing a false report or record in the practice of psychiatry as a psychiatrist's assistant or aiding another individual to do so; (9) Willfully failing to file or record any report as required under law, willfully impeding or obstructing the filing or recording of a report, or inducing another to fail to file or record a report; (10) Making a willful misrepresentation in treatment; (11) Practicing as a psychiatrist's assistant with an unauthorized individual or aiding an unauthorized individual in practice as a psychiatrist's assistant; (12) Being disciplined by a licensing or disciplinary authority or being convicted or disciplined by a court of any state or country or disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under this regulation; (13) Failing to meet appropriate standards for the delivery of quality performance as a psychiatrist's assistant in this State; (14) Willfully submitting false statements to collect fees for which services are not provided; (15) Knowingly failing to report suspected child abuse in violation of Family Law Article, §5-903, Annotated Code of Maryland; (16) Selling, prescribing, giving away, or administering medical prescription drugs, narcotics, or controlled dangerous substances, as defined in Criminal Law Article, Annotated Code of Maryland, for illegal or illegitimate medical purposes; (17) Breaching patient confidentiality; (18) Practicing beyond the authorized scope of practice; (19) Performing delegated medical acts other than under the supervision of a psychiatrist approved by the Board; (20) Refusing, withholding from, denying, or discriminating against a patient with regard to the provision of professional services for which the psychiatrist's assistant is registered and qualified to render because the patient may be HIV positive; (21) Practicing or attempting to practice any delegated act as a psychiatrist's assistant without having received education, internship, training, or experience in the performance of that procedure; (22) Soliciting professional patronage through an agent or other individuals or profits from the acts of an individual who is represented as an agent of the psychiatrist's assistant; (23) Paying or agreeing to pay any sum to an individual for bringing or referring a patient or accepting or agreeing to accept any sum from an individual for bringing or referring a patient; (24) Failing to comply with these regulations; (25) On proper request, failing to provide, in writing, details of a patient's records to another health care provider, institution, or hospital; and (26) Except in an emergency life-threatening situation, failing to comply with the Centers for Disease Control's guidelines on universal precautions. C. Crimes Involving Moral Turpitude. (1) Subject to the Administrative Procedure Act, the Board shall order the suspension of a registration of a psychiatrist's assistant if the psychiatrist's assistant is convicted of or pleads guilty or nolo contendere with respect to a crime involving moral turpitude whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. (2) After completion of the appellate process, if the conviction has not be reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a psychiatrist's assistant's registration subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland. D. Surrender. Unless the Board agrees to accept the surrender of a registration, a psychiatrist's assistant may not surrender the registration nor may the registration lapse by operation of law while the psychiatrist's assistant is under investigation or while charges are pending against the assistant. E. Unprofessional Conduct. Unprofessional conduct in the practice of medicine as defined by Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland, includes the failure of a physician to comply with the statute and regulations governing supervising physicians and psychiatrist's assistants. F. Complaints. Individuals may refer complaints alleging prohibited conduct to the Board to be investigated according to the Board's procedures. ### Chapter 05 — Telehealth **Authority:** Health Occupations Article, §§1-213, 1-606, 1-1003, 1-1006, 14-205, Annotated Code of Maryland **Administrative History:** Effective date: December 28, 2009 (36:26 Md. R. 1995) **Administrative History:** Regulations .01—.07, Telemedicine, repealed and new Regulations .01—.07, Telehealth, adopted effective August 12, 2019 (46:16 Md. R. 688) **Administrative History:** Regulation .02B amended effective September 15, 2025 (52:18 Md. R. 923) **Administrative History:** Regulation .03 amended effective September 15, 2025 (52:18 Md. R. 923) **Administrative History:** Regulation .04 amended effective September 15, 2025 (52:18 Md. R. 923) **Administrative History:** Regulation .05 amended effective September 15, 2025 (52:18 Md. R. 923) **Administrative History:** Regulation .06 B, C amended effective September 15, 2025 (52:18 Md. R. 923) **Administrative History:** Regulation .06C amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .06D adopted effective September 15, 2025 (52:18 Md. R. 923) #### Regulation .01 Scope. *COMAR 10.32.05.01* This chapter governs the practice of medicine using telehealth as an adjunct to, or replacement for, in-person patient visits. #### Regulation .02 Definitions. *COMAR 10.32.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Asynchronous” means not occurring in real time. (2) “In-person” means within the physical presence of the patient. (3) “Interpretive services” means reading and analyzing images, tracings, or specimens through telehealth or giving interpretations based on visual, auditory, thermal, or ultrasonic patterns or other patterns as may evolve with technology. (4) “Synchronous” means occurring in real time. (5) Telehealth. (a) “Telehealth” means a mode of delivering health care services through the use of telecommunications technologies by a health care practitioner to a patient at a different physical location than the telehealth practitioner. (b) “Telehealth” includes synchronous and asynchronous interactions. (c) “Telehealth” does not include the provision of health care services solely through: (i) Audio–only calls; (ii) E–mail messages; or (iii) Facsimile transmissions. (6) “Telehealth practitioner” means a Maryland licensed physician or licensed allied health practitioner performing telehealth services within their respective scope of practice. #### Regulation .03 Licensure. *COMAR 10.32.05.03* A. Except as specified in Health Occupations Article, §14-302, Annotated Code of Maryland, a telehealth practitioner shall be licensed when providing telehealth services to a patient located in the State. B. Telehealth practitioners licensed in the State are subject to the jurisdiction of the State and shall abide by the telehealth requirements of this chapter if either the practitioner or patient is physically located in this State. #### Regulation .04 Specific Telehealth Requirements. *COMAR 10.32.05.04* A. Before performing telehealth services, a telehealth practitioner shall develop and follow a procedure to: (1) Verify the identification of the patient receiving telehealth services within a reasonable degree of certainty through use of: (a) Government issued photograph identification; (b) Insurance, Medicaid, or Medicare card; or (c) Documentation of the patient’s: (i) Date of birth; and (ii) Home address; (2) For an initial patient encounter, disclose the telehealth practitioner’s name, contact information, license type, and medical specialty, if any; (3) Except for interpretive services, obtain oral or written consent from a patient or the patient’s parent or guardian if State law requires the consent of a parent or guardian including informing patients of the risks, benefits, and side effects of prescribed treatments; (4) Securely collect and transmit a patient’s medical information, clinical data, clinical images, laboratory results, and self–reported medical history, as necessary and prevent access to data by unauthorized persons through encryption or other means; (5) Notify patients in the event of a data breach; (6) Ensure that the telehealth practitioner provides a secure and private telehealth connection that complies with federal and state privacy laws; and (7) Establish safety protocols to be used in the case of an emergency. B. Except when providing asynchronous telehealth services, a telehealth practitioner shall: (1) Obtain or confirm an alternative method of contacting the patient in case of a technological failure; (2) Confirm whether the patient is in Maryland and identify the practice setting in which the patient is located; and (3) Identify all individuals present at each location and confirm they are allowed to hear personal health information. C. The requirements set forth under §§A and B of this regulation may be delegated. #### Regulation .05 Patient Evaluation. *COMAR 10.32.05.05* A. A telehealth practitioner shall perform a synchronous or asynchronous clinical patient evaluation that is appropriate for the patient and the condition with which the patient presents before providing treatment or issuing a prescription through telehealth. B. A telehealth practitioner shall, if clinically appropriate for the patient, provide or refer a patient to in-person health care services or another type of telehealth service. #### Regulation .06 Standard Related to Telehealth. *COMAR 10.32.05.06* A. A telehealth practitioner shall be held to the same standards of practice and documentation as those applicable in in-person health care settings. B. A telehealth practitioner may not treat a patient or prescribe medication based solely on a static online questionnaire. C. A telehealth practitioner may not prescribe an opiate described in the list of Schedule II substances under Criminal Law Article, §5-403, Annotated Code of Maryland for the treatment of pain through telehealth unless: (1) The patient is in a health care facility as defined in Health-General Article, §19-114(d)(1), Annotated Code of Maryland; (2) The Governor has declared a state of emergency due to a catastrophic health emergency; or (3) There is an established bona fide practitioner-patient relationship in which the telehealth practitioner has ongoing responsibility for the assessment, care, and treatment of the patient and the telehealth practitioner, or another health care practitioner in the same group practice, as defined in Health Occupations Article, §1-301, Annotated Code of Maryland, previously conducted an in-person assessment of the patient. D. A telehealth practitioner shall comply with all State and federal laws and regulations related to dispensing including the prohibition on mail order dispensing. #### Regulation .07 Telehealth Practitioner Discipline. *COMAR 10.32.05.07* A. The Board shall use the same standards in evaluating and investigating a complaint about and in disciplining a licensee who practices telehealth as it would use for a licensee who does not use telehealth technology in the licensee’s practice. B. The failure of a telehealth practitioner to comply with Regulation .04, .05, or .06 of this chapter shall constitute unprofessional conduct. ### Chapter 06 — Licensure of Polysomnographic Technologists **Authority:** Health Occupations Article, §§1-213, 1-221, 1-606, 14-205, and 14-5C-01—14-5C-23, Annotated Code of Maryland **Administrative History:** Effective date: December 1, 2008 (35:24 Md. R. 2078) **Administrative History:** Regulation .01B amended as an emergency provision effective October 1, 2009 (36:17 Md. R. 1311); amended permanently effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .01B amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .01E, F adopted effective May 11, 2015 (42:9 Md. R. 647) **Administrative History:** Regulation .02B amended effective August 15, 2016 (43:16 Md. R. 900); September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .04 amended effective December 22, 2014 (41:25 Md. R. 1485); September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .04A amended effective June 20, 2016 (43:12 Md. R. 667) **Administrative History:** Regulation .04C repealed effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .04G amended as an emergency provision effective October 1, 2009 (36:17 Md. R. 1311); amended permanently effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .04G amended effective March 5, 2012 (39:4 Md. R. 337) **Administrative History:** Regulation .06 amended effective September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .07 amended effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .07A amended effective September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .07B, C amended effective December 22, 2014 (41:25 Md. R. 1485) **Administrative History:** Regulation .08B amended effective August 15, 2016 (43:16 Md. R. 900); January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .09 amended effective May 11, 2015 (42:9 Md. R. 647); September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .10 amended effective September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .10A amended effective May 11, 2015 (42:9 Md. R. 647) **Administrative History:** Regulation .11 amended effective September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .12 amended effective May 11, 2015 (42:9 Md. R. 647); September 29, 2025 (52:19 Md. R. 956) **Administrative History:** Regulation .12D—H adopted effective July 22, 2013 (40:14 Md. R. 1175) **Administrative History:** Regulation .13 adopted effective July 22, 2013 (40:14 Md. R. 1175) **Administrative History:** Regulation .13 amended effective May 11, 2015 (42:9 Md. R. 647) **Administrative History:** Regulation .13A amended effective September 29, 2025 (52:19 Md. R. 956) #### Regulation .01 Scope. *COMAR 10.32.06.01* A. This chapter governs the practice of polysomnographic technology. B. Except as provided in §C or D of this regulation, on or before October 1, 2013, an individual shall be licensed by the Board before the individual may practice polysomnography. C. This chapter does not prohibit any polysomnographic technology student who is currently enrolled in an approved polysomnographic technology educational program from performing any of the procedures described in this chapter as part of that program's polysomnographic technology clinical curriculum. D. This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland. E. This chapter does not prohibit a licensed respiratory care practitioner from practicing respiratory care within the scope of practice of the respiratory care practitioner’s license, including practicing respiratory care in a sleep laboratory. F. This chapter does not prohibit the practice of respiratory care by a practitioner who was licensed by the Board to practice respiratory care on or before December 31, 2012, and whose duties include practicing polysomnography. #### Regulation .02 Definitions. *COMAR 10.32.06.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Physicians. (2) “Board eligible” means a physician’s status that starts upon completion of all the requirements to take a sleep medicine certifying examination and lasts for a limited period of time, as determined by the American Board of Medical Specialties or the American Osteopathic Association. (3) “Capnography” means measurement of the amount of CO2 being eliminated from the lungs. (4) “Committee” means the Polysomnography Professional Standards Committee established under Health Occupations Article, §14-5C-05, Annotated Code of Maryland. (5) “Direct supervision” means supervision by a licensed physician who is physically present on the premises while services are provided. (6) “Electroencephalography” means a test that measures the electrical activity of the brain as recorded by electrodes placed on the scalp. (7) “Electromyography” means a test that measures the electrical activity of the muscles. (8) “Electrooculography” means a test that measures the movements of the eye. (9) “Enrolled in a sleep technologist educational program” means that a student has started the Accredited Sleep Technology Program self-study online modules developed by the American Academy of Sleep Medicine but has not completed the final self-study module. (10) “General supervision” means supervision by a licensed physician who is available to give immediately available direction, either in person, by telephone, or by electronic means. (11) “License” means a license issued by the Board. (12) “Licensed polysomnographic technologist” means an individual licensed by the Board to practice polysomnography under the supervision of a licensed physician. (13) “Licensed physician” means an individual who is licensed by the Board to practice medicine. (14) “Oximetry” means a test that measures the concentration of oxygen in the blood. (15) “PH probe” means a device to measure the acidity of the esophagus. (16) “Plethysmography” means a test to measure changes in blood flow or air volume in different parts of the body. (17) “Practice polysomnography” means: (a) Monitoring and recording physiologic data during sleep, including sleep-related respiratory disturbances, under the supervision of a licensed physician; and (b) Using the data collected under §B(17)(a) of this regulation for the purposes of assisting a licensed physician in the diagnosis and treatment of sleep and wake disorders. (18) “Registered polysomnographic technologist” means a polysomnographic technologist who is registered by the Board of Registered Polysomnographic Technologists. (19) “Student” means an individual who is: (a) Enrolled in an accredited educational program in order to qualify for a license as a polysomnographic technologist; and (b) Performing polysomnography services within the accredited program under the supervision of a licensed physician and without compensation. (20) “Supervision” means general supervision or direct supervision of a licensed polysomnographic technologist by a licensed physician. #### Regulation .03 Committee. *COMAR 10.32.06.03* A. The Board shall appoint members of the Polysomnographic Professional Standards Committee as follows: (1) Three polysomnographic technologists who: (a) Before October 1, 2009, are registered polysomnographic technologists; and (b) On or after October 1, 2009, are both registered polysomnographic technologists and licensed polysomnographic technologists; (2) Three licensed physicians with specialty certification in sleep medicine who are specialists in the following areas: (a) One in psychiatry or internal medicine; (b) One in pulmonary medicine; and (c) One in neurology; and (3) One consumer member who is a member of the general public and who: (a) May not be or ever has been: (i) A polysomnographic technologist; (ii) A health care professional; (iii) In training to be a polysomnographic technologist or other health care professional; or (iv) A household member of a health care professional or an individual in training to be a health care professional; and (b) May not: (i) Participate, or ever have participated, in a commercial or professional field related to polysomnography; (ii) Have a household member who participates in a commercial or professional field related to polysomnography; (iii) Have had, within 2 years before appointment, a financial interest in a individual regulated by the Board; or (iv) Have had, within 2 years before appointment, a financial interest in the provision of goods or services to polysomnographic technologists or to the field of polysomnography. B. Tenure. (1) The term of a member is 3 years. (2) The terms of the members are staggered. (3) At the end of a term, a member continues to serve until a successor is appointed. (4) An individual may be reappointed for a second term but the individual may not serve more than two full consecutive terms. C. Vacancy. (1) If a vacancy occurs, the Board shall appoint a new member to serve. (2) The successor member shall only serve for the remainder of the term, unless reappointed. D. Quorum. (1) A majority of the members then serving on the Committee is a quorum. (2) Business may not be conducted at a Committee meeting unless there is a quorum. E. The Committee shall: (1) Make recommendations to the Board regarding the practice of, and regulations governing, polysomnographic technologists; (2) Make recommendations to the Board on the requirements for licensure as a polysomnographic technologist; (3) Review selected applications for licensure as a polysomnographic technologist and make recommendations to the Board on the applications; (4) At the request of the Board, review complaints against polysomnographic technologists and respond to the Board's questions; and (5) Keep a record of the Committee's proceedings. #### Regulation .04 Application for Initial Licensure as a Polysomnographic Technologist. *COMAR 10.32.06.04* A. An applicant shall: (1) Complete an application on a form supplied by the Board; (2) Pay the required application fee set by the Board in Regulation .09 of this chapter; (3) Be 18 years old or older; (4) Be of good moral character; (5) Demonstrate spoken and written competency in English by any of the following: (a) Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Documentation of graduation from a recognized English-speaking professional school; or (c) Documentation of receiving a grade of at least: (i) 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) 79 on the Internet-based Test of English as a Foreign Language; (6) Provide documentation of current certification as a registered polysomnographic technologist by the Board of Registered Polysomnographic Technologists or by another national certification agency approved by the Board; (7) Provide documentation of licensure, certification, or registration from all states where the applicant has ever held a license, certificate, or registration in any health profession; and (8) Meet the requirements of §B of this regulation. B. An applicant shall meet the requirements of one of the following pathways to licensure: (1) Graduation from a polysomnographic educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs; (2) In regard to a respiratory care educational program: (a) Graduation from a respiratory care educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs; and (b) Completion of the Committee on Accreditation for Respiratory Care’s curriculum for a polysomnography certificate that is accredited by the Commission on Accreditation of Allied Health Education Programs; (3) In regard to an electroneurodiagnostic technology educational program: (a) Graduation from an electroneurodiagnostic technology educational program that is accredited by the Commission on Accreditation of Allied Health Education Programs; and (b) Completion of an add-on track in polysomnography for electroneurodiagnostic technologists that is accredited by the Commission on Accreditation of Allied Health Education Programs; or (4) In regard to a sleep technologist educational program, completion of the requirements of §C of this regulation. C. An applicant who has graduated from a sleep technologist education program accredited by the American Academy of Sleep Medicine shall: (1) Provide proof of meeting core competencies in the 3 years preceding the date of the submission of the licensure application as assessed by a sleep technologist credentialed as a Registered Polysomnographic Technologist, a sleep technologist with national certification approved by the Board, or a physician who is either board-eligible or board-certified in sleep medicine by the American Board of Sleep Medicine, American Board of Medical Specialties, or American Osteopathic Association; (2) Provide a letter of attestation for completion of clinical hours and competencies from a physician who is either board-eligible or board-certified in sleep medicine by the American Board of Sleep Medicine, American Board of Medical Specialties, or American Osteopathic Association where the applicant practiced; and (3) Provide proof of completion of a minimum of 546 hours of clinical experience in the 3 years preceding the date of the submission of the licensure application as either: (a) A student enrolled in a sleep technologist educational program supervised at a sleep laboratory accredited by the American Academy of Sleep Medicine or The Joint Commission by: (i) A sleep technologist credentialed as a Registered Polysomnographic Technologist; (ii) A sleep technologist with national certification approved by the Board; or (iii) A licensed physician who is either board-eligible or board-certified in sleep medicine by the American Board of Sleep Medicine, American Board of Medical Specialties, or American Osteopathic Association; or (b) A sleep technologist with a current, active, unrestricted license in another state or is otherwise recognized and has practiced as a sleep technologist in another state who has: (i) Full-time practice experience as a sleep technologist in another state at a sleep laboratory accredited by the American Academy of Sleep Medicine or The Joint Commission for a minimum of 6 months in the 3 years preceding the date of the submission of the licensure application; and (ii) Completed at least 30 hours of approved continuing education in the 3 years preceding the date of the submission of the licensure application. #### Regulation .05 Scope of Practice. *COMAR 10.32.06.05* A. A licensed polysomnographic technologist may practice only under the supervision of a licensed physician. B. A licensed polysomnographic technologist may practice only in a hospital sleep laboratory or a stand-alone sleep center. C. The scope of practice of a licensed polysomnographic technologist includes and is limited to the following: (1) Monitoring and recording physiologic data during sleep, including sleep-related respiratory disturbances; (2) Using data collected under §C(1) of this regulation to assist a licensed physician in the diagnosis and treatment of sleep and wake disorders; (3) Assisting with the diagnosis and treatment of individuals who suffer from sleep disorders as a result of developmental defects, the aging process, physical injury, disease, or actual or anticipated somatic dysfunction; (4) Observing and monitoring physical signs and symptoms, general behavior, and general physical responses to polysomnographic evaluation, and determining whether initiation, modification, or discontinuation of a treatment regimen is warranted; (5) Using evaluation techniques that include limited cardiopulmonary function assessments, the need and effectiveness of therapeutic modalities and procedures, and the assessment and evaluation of the need for extended care; and (6) Using the following techniques, equipment, and procedures: (a) Continuous positive airway pressure, bi-level positive airway pressure titration, or adaptive servo-ventilation on spontaneously breathing patients; (b) Supplemental low flow oxygen therapy during polysomnogram; (c) Capnography during polysomnogram; (d) Cardiopulmonary resuscitation; (e) Pulse oximetry; (f) PH probe placement and monitoring; (g) Esophageal pressure; (h) Sleep staging, including surface electroencephalography, surface electrooculography, and surface submental electromyography; (i) Surface electromyography of arms and legs; (j) Electrocardiography; (k) Respiratory effort, including thoracic and abdominal; (l) Plethysmography blood flow; (m) Snore monitoring; (n) Audio or video monitoring; (o) Implementation of a written or verbal order from a licensed physician that requires the practice of polysomnography; (p) Monitoring the effects a nasal device used to treat sleep apnea has on sleep patterns provided that the device does not extend into the trachea; and (q) Monitoring the effects an oral device used to treat sleep apnea has on sleep patterns provided that: (i) The oral device does not extend into the trachea; (ii) A dentist has evaluated the structures of the patient's oral and maxillofacial region for purposes of fitting the oral device; (iii) A dentist made or directed the making of the oral device; and (iv) A dentist directs the use of the oral device. D. The scope of practice of a polysomnographic technologist does not include administering medications. #### Regulation .06 Identification as Polysomnographic Technologist; Notice of Name or Address Change. *COMAR 10.32.06.06* A. A licensed polysomnographic technologist shall wear an identification tag or a badge displaying in readily visible type that the individual is a licensed polysomnographic technologist. B. An individual may not identify himself or herself as a polysomnographic technologist unless the individual is licensed by the Board. C. Change of Name or Address. (1) A licensed polysomnographic technologist shall advise the Board in writing of any change in name or mailing address within 60 days. (2) The Board may impose a fine of $100 for failure to notify the Board of a change in name or mailing address. #### Regulation .07 Renewal and Reinstatement. *COMAR 10.32.06.07* A. Renewal. (1) The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment. (2) An individual who has been licensed by the Board as a polysomnographic technologist may renew the license on or before the date specified by the Board by: (a) Submitting a renewal application on a form supplied by the Board; (b) Paying the required renewal fee set by the Board in Regulation .09 of this chapter; (c) Attesting to the completion of at least 20 hours of approved continuing education, earned during the 2-year period preceding the expiration of the license, as specified in Regulation .08 of this chapter; and (d) Meeting any other requirement set by the Board. B. Reinstatement. The Board shall reinstate the license of a polysomnographic technologist if the polysomnographic technologist: (1) Completes a reinstatement application on a form supplied by the Board; (2) Pays the required reinstatement fee and any other fees specified in Regulation .09 of this chapter; (3) Documents evidence of completion of at least 20 hours of approved continuing education in the 2-year period preceding the date of the submission of the application for reinstatement, as specified in Regulation .08 of this chapter; and (4) Meets any additional requirements set by the Board for reinstatement of a license. #### Regulation .08 Continuing Education. *COMAR 10.32.06.08* A. Application. (1) A licensed polysomnographic technologist is not required to obtain continuing education hours for the first renewal after initial licensure or reinstatement. (2) Except as stated in §A(1) of this regulation, the Board may not renew or reinstate the license of a polysomnographic technologist unless the polysomnographic technologist has met the requirements for continuing education described in §B of this regulation. B. Requirements. (1) A polysomnographic technologist shall earn at least 20 continuing education hours as described in §B(2) of this regulation during the 2-year period preceding: (a) For license renewal, the expiration of the license for polysomnographic technologist; or (b) For license reinstatement, the date of the submission of the application for reinstatement. (2) The Board shall recognize sleep-related continuing education hours approved by one of the following organizations or any other organization recommended by the Committee and approved by the Board: (a) American Medical Association; (b) American Association of Sleep Technologists; (c) American Academy of Sleep Medicine; (d) American Society of Electroneurodiagnostic Technologists, Inc.; (e) American Association for Respiratory Care; (f) American Nursing Association; or (g) Board of Registered Polysomnographic Technologists C. Documentation of Continuing Education Hours. (1) A polysomnographic technologist shall obtain the required documentation of continuing education attendance and retain this documentation for the succeeding 6 years for possible inspection by the Board. (2) The required documentation shall contain the: (a) Program title; (b) Sponsor's name; (c) Polysomnographic technologist's name; (d) Number of continuing education hours earned; (e) Verification of successful completion by signature, stamp, or other official proof; and (f) Date of the continuing education activity. #### Regulation .09 Fees. *COMAR 10.32.06.09* A. The following fees are applicable to polysomnographic technologists: (1) Initial licensure application fee — $200; (2) License renewal fees: (a) License renewal fee — $150; and (b) Maryland Health Care Commission (MHCC) fee — As determined by MHCC in accordance with COMAR 10.25.02; (3) Reinstatement fee — $200; and (4) Written verification of licensure fee — $25. B. Fees paid to the Board are non-refundable. #### Regulation .10 Prohibited Conduct. *COMAR 10.32.06.10* A. Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, and in accordance with COMAR 10.32.02, a disciplinary panel may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee: (1) Fraudulently, or deceptively obtains or attempts to obtain a license for the applicant or licensee, or for another; (2) Fraudulently or deceptively uses a license; (3) Is guilty of unprofessional or immoral conduct in the practice of polysomnography; (4) Is professionally, physically, or mentally incompetent; (5) Abandons a patient; (6) Is habitually intoxicated; (7) Is addicted to or habitually abuses any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; (8) Provides professional services while: (a) Under the influence of alcohol; or (b) Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts or without valid medical indication; (9) Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain; (10) Willfully makes or files a false report or record in the practice of polysomnography; (11) Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report; (12) Breaches patient confidentiality; (13) Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any individual for bringing or referring a patient, or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient; (14) Knowingly makes a misrepresentation while practicing polysomnography; (15) Knowingly practices polysomnography with an unauthorized individual, or aids an unauthorized individual in the practice of polysomnography; (16) Knowingly delegates a polysomnographic duty to an unlicensed individual; (17) Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine; (18) Is disciplined by a licensing or disciplinary authority, is convicted or disciplined by a court of any state or country, or is disciplined by any branch of the United States uniformed services or the U.S. Department of Veterans Affairs for an act that would be grounds for disciplinary action under the Board's disciplinary statutes; (19) Fails to meet appropriate standards for the delivery of polysomnographic services performed in a hospital sleep laboratory or a stand-alone sleep center; (20) Knowingly submits false statements to collect fees for which services are not provided; (21) Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes and has: (a) Surrendered the license, if any, issued by the state or country; or (b) Allowed the license, if any, issued by the state or country to expire or lapse; (22) Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (23) Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes; (24) Practices or attempts to practice beyond the authorized scope of practice; (25) Is convicted of, or pleads guilty or nolo contendere to, a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; (26) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; (27) Practices or attempts to practice a polysomnography procedure or uses or attempts to use polysomnography equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment; or (28) Fails to cooperate with a lawful investigation conducted by the Board. B. Crimes of Moral Turpitude. (1) Proceedings for crimes of moral turpitude under Health Occupations Article, §14-5C-17(c), Annotated Code of Maryland, shall be held in accordance with COMAR 10.32.02.07. (2) On the filing of certified docket entries with the Board by the Office of the Attorney General, a disciplinary panel shall order the suspension of a license if the licensee is convicted of, or pleads guilty or nolo contendere with respect to, a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. (3) After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the disciplinary panel shall order the revocation of a license on the certification by the Office of the Attorney General. #### Regulation .11 Required Reports. *COMAR 10.32.06.11* A reporting entity, as defined in COMAR 10.32.22.02, shall file all required reports in accordance with Health Occupations Article, §14-5C-18, Annotated Code of Maryland, and COMAR 10.32.22. #### Regulation .12 Penalties, Fines, and Sanctions. *COMAR 10.32.06.12* A. An individual who violates any provision of Heath Occupations Article, Title 14, Subtitle 5C, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000 or imprisonment not exceeding 1 year, or both. B. An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5C, Annotated Code of Maryland, or any regulation in this chapter, is subject to a civil fine of not more than $5,000 to be levied by the Board or a disciplinary panel. C. The Board shall pay any penalty collected under §A or B of this regulation into the Board of Physicians Fund. D. Employment of Unlicensed Polysomnography Practitioner. (1) A person who violates Health Occupations Article, §14-5C-22.1, Annotated Code of Maryland, is subject to a civil fine of not more than $5,000 to be levied by the Board. (2) The Board shall pay any fine collected under §D of this regulation into the State’s General Fund. E. The Board may impose a fine up to $1,000 for a reporting entity, as defined in COMAR 10.32.22.02, that fails to make a report to the Board required by COMAR 10.32.22. F. General Application of Sanctioning Guidelines. (1) Sections F and G of this regulation and Regulation .13 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §G of this regulation, for violations of the sections of the Maryland Polysomnography Act listed in the sanctioning guidelines, a disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation. (c) A stayed suspension not meeting the criteria for §F(3)(b) of this regulation is ranked as a reprimand. (4) The disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and (b) The disciplinary panel may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .13 of this chapter, in order to resolve a pending disciplinary action, the disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms and sanction agreed to by the disciplinary panel, the administrative prosecutor, and the licensee. (8) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (9) If the disciplinary panel imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .13 of this chapter, the disciplinary panel shall state its reasons for doing so in its final decision and order. G. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the disciplinary panel may consider the aggravating and mitigating factors set out in §G(4)—(5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires the disciplinary panel or an Administrative Law Judge to make findings of fact with respect to any of these factors. (3) The existence of one or more of these factors does not impose on the disciplinary panel or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (4) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (5) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. (6) A departure from the sanctioning guidelines set forth in Regulation .13 of this chapter is not a ground for any hearing or appeal of a disciplinary panel action. H. Offenses Related to Continuing Education Requirements. (1) If a licensee has submitted an application claiming the completion of continuing education credits and the licensee fails to document the completion of such continuing education credits when audited by the Board, the licensee may be charged under one or more of the following, as appropriate: (a) Health Occupations Article, §14-5C-17(a)(3), Annotated Code of Maryland; (b) Health Occupations Article, §14-5C-17(a)(10), Annotated Code of Maryland; and (c) Health Occupations Article, §14-5C-17(a)(11), Annotated Code of Maryland. (2) Upon a finding of a violation, the disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5C-17, Annotated Code of Maryland, and the sanctioning guidelines. I. Payment of Fines Imposed by the Board or a Disciplinary Panel. (1) An individual shall pay to the Board any fine imposed pursuant to this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise. (2) Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed pursuant to this regulation. (3) If an individual fails to pay, in whole or in part, a fine imposed pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full. (4) In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the State Department of Budget and Management to institute and maintain proceedings to ensure an individual’s prompt payment. #### Regulation .13 Sanctioning Guidelines for Polysomnographic Technologists. *COMAR 10.32.06.13* A. A. Subject to provisions of Regulation .12F and G of this chapter, a disciplinary panel may impose sanctions as outlined in §B of this regulation on polysomnographic technologists for violations of Health Occupations Article, §14-5C-17(a), Annotated Code of Maryland. B. Range of Sanctions. ### Chapter 07 — Unlicensed Medical Practitioners *Repealed* **Administrative History:** Effective date: February 11, 1985 (12:3 Md. R. 245) **Administrative History:** Regulation .01 amended effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Regulation .02 amended effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Regulation .03 amended effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Regulation .04 amended effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Regulations .07 and .08 repealed effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Regulation .07 adopted effective September 11, 1995 (22:18 Md. R. 1399) **Administrative History:** Chapter repealed effective April 23, 2018 (45:8 Md. R. 422) ### Chapter 08 — Licensure of Athletic Trainers **Authority:** Health Occupations Article, §§1-213, 1-606, 14-205 and 14-5D-01—14-5D-20, Annotated Code of Maryland **Administrative History:** Effective date: July 22, 2013 (40:14 Md. R. 1176) **Administrative History:** Regulation .01A amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .02B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .05C, D amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .06A amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .06B amended effective July 31, 2017 (44:15 Md. R. 760) **Administrative History:** Regulation .06E adopted effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .07 amended effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .09A amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .12B amended effective January 19, 2026 (53:1 Md. R. 21) #### Regulation .01 Scope. *COMAR 10.32.08.01* A. This chapter governs the practice of athletic training including “dry needling” within the practice of athletic training. B. This chapter does not prohibit an athletic training student who is enrolled in an accredited athletic training educational program from performing without pay any of the procedures described in this chapter as part of that program’s athletic training clinical curriculum. C. This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland. D. This chapter does not prohibit an individual employed by the federal government as an athletic trainer from practicing within the scope of that employment. E. This chapter does not apply to an individual employed by or under contract with an entity located in another state who represents that entity: (1) At an athletic event in Maryland; (2) For a period not exceeding 45 days within a calendar year; and (3) By providing athletic training services to individuals representing the entity at the event. #### Regulation .02 Definitions. *COMAR 10.32.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited athletic training educational program” means an athletic training educational program that: (a) Awards either a bachelor’s or master’s degree in athletic training; and (b) Is accredited by the Commission on Accreditation of Athletic Training Education or its successor. (2) “Alternate supervising physician” means one or more physicians designated by the supervising physician to provide supervision of an athletic trainer: (a) During the absence of the supervising physician; and (b) In accordance with the evaluation and treatment protocol on file with the Board. (3) “Athlete” means an individual who participates in an athletic activity. (4) “Athletic activity” means an exercise, recreation, sport, competition, or game that: (a) Requires physical strength, range of motion, flexibility, control, speed, stamina, or agility; and (b) Is associated with a setting as defined under this section, an educational institution or a professional, amateur, or recreational sports club or athletic organization. (5) “Athletic injury” means an injury that affects an athlete’s participation or performance in an athletic activity. (6) “Board” means the State Board of Physicians. (7) “Certifying board” means the Board of Certification, Inc., or its successor. (8) “Committee” means the Athletic Trainer Advisory Committee of the Board. (9) “Dry needling” means an intramuscular therapy that: (a) Involves the insertion of one or more solid needles into the muscle and related tissues to effect change in the muscle and related tissues; (b) Requires ongoing evaluation, assessment, and reevaluation of an impairment; (c) Is used only in parts of the body with neuromuscular or musculoskeletal links to an impairment; and (d) Is not performed for: (i) The purpose of acupuncture as defined in Health Occupations Article, §1A-101, Annotated Code of Maryland; or (ii) Any purpose outside of the scope of practice of athletic trainers. (10) “Evaluation and treatment protocol” means a document that is executed by a physician and an athletic trainer that meets the requirements in Regulation .06 of this chapter. (11) “Immediately available instruction” means instruction provided by the supervising physician to the athletic trainer in person, by telephone, or by other electronic means. (12) “Licensed athletic trainer” means an individual licensed by the Board to practice athletic training. (13) “Licensed health care practitioner” means an individual licensed, certified, or otherwise authorized to practice a health occupation under Health Occupations Article, Annotated Code of Maryland. (14) “Nonsupervising physician” means a physician licensed by the Board who is not the supervising physician of the athletic trainer. (15) “Outside referral” means a request for treatment from a nonsupervising physician or licensed health care practitioner. (16) “Physician” means an individual licensed to practice medicine in Maryland under Health Occupations Article, Title 14, Annotated Code of Maryland. (17) Practice Athletic Training. (a) “Practice athletic training” means application of the following principles and methods for managing athletic injuries for athletes in good overall health under the supervision of a licensed physician: (i) Prevention; (ii) Clinical evaluation and assessment; (iii) Immediate care; and (iv) Treatment, rehabilitation, and reconditioning. (b) “Practice athletic training” includes: (i) Organization and administration of an athletic training program; and (ii) Instruction to coaches, athletes, parents, medical personnel, and community members regarding the care and prevention of athletic injuries. (c) “Practice athletic training” does not include any of the following: (i) The practice of chiropractic, including adjustments, manipulation, or high-velocity mobilizations of the spine or extremities; (ii) The practice of massage therapy; (iii) The practice of medicine; (iv) The practice of occupational therapy; (v) The practice of physical therapy; (vi) The practice of podiatry; (vii) The reconditioning of systemic neurologic injuries, conditions, or disease; or (viii) Except for the conditioning of an athlete under the supervision of a treating physician, the treatment, rehabilitation, or reconditioning of nonathletic injuries or disease. (18) “Setting” means a: (a) Location where an athletic activity, as defined in §B(4) of this regulation, is being held; (b) Health or fitness club; (c) Clinic or hospital; (d) Corporation; or (e) Government agency. (19) “Supervising physician” means a physician who has been approved by the Board to supervise one or more athletic trainers. (20) “Supervision” means the responsibility of a physician to provide ongoing and immediately available instruction, in person, by telephone, or by other electronic means, that is adequate to ensure the safety and welfare of a patient and is appropriate to the setting. (21) “Supervision mechanism” means continuous availability to the athletic trainer of a supervising physician by one or more of the following means: (a) On-site supervision; (b) Written instructions; (c) Electronic means; (d) Verbal orders; and (e) Designation of an alternate supervising physician. (22) Therapeutic Modalities. (a) “Therapeutic modalities” means a variety of physical agents used to treat athletic injuries in an effort to decrease pain, reduce inflammation, decrease swelling, decrease muscle spasm, and provide a proper environment for the healing process to take place. (b) “Therapeutic modalities” does not include the use of a prescription or nonprescription drug. #### Regulation .03 Committee. *COMAR 10.32.08.03* A. The Board shall establish a committee composed of the following individuals: (1) Three licensed physicians meeting the following criteria: (a) At least one physician shall be a specialist in orthopedic or sports medicine; and (b) At least two of the physicians shall currently be or in the past have been partnered with or directed an athletic trainer; (2) Three athletic trainers who meet the following criteria: (a) Have at least 5 years of clinical experience as an athletic trainer; (b) If appointed or serving before October 1, 2011, be certified by the certifying board; and (c) If appointed or serving on or after October 1, 2011, be licensed as an athletic trainer; (3) One licensed chiropractor with sports medicine experience; (4) One licensed physical therapist; (5) One licensed occupational therapist; and (6) Two consumers meeting the criteria specified in Health Occupations Article, §14-5D-05(c), Annotated Code of Maryland. B. Selection of Athletic Trainers. The Board may appoint the athletic trainer members from a list of qualified individuals submitted to the Board by the Maryland Athletic Trainers Association, Inc. C. Tenure. (1) The term of a member is 3 years. (2) The terms of the members are staggered. (3) At the end of a term, a member continues to serve until a successor is appointed. (4) An individual may be reappointed for a second term, but the individual may not serve more than two full, consecutive terms. D. Vacancy. (1) If a vacancy occurs, the Board shall appoint a new member to serve, as provided in this chapter. (2) The successor member shall serve only for the remainder of the term, unless reappointed. E. Chair. (1) The Committee shall elect a chair from among its members. (2) The chair shall serve for 2 years. F. The Committee shall: (1) Make recommendations to the Board regarding: (a) Regulations governing athletic trainers; (b) Continuing education requirements for license renewal; and (c) The practice of athletic training; (2) Develop and recommend to the Board an evaluation and treatment protocol for use by an athletic trainer and the physician with whom the athletic trainer practices; (3) Upon request of the Board, provide advice and recommendations to the Board on individual evaluation and treatment protocols; and (4) Keep a record of the Committee’s proceedings. #### Regulation .04 Qualifications for Licensure as an Athletic Trainer. *COMAR 10.32.08.04* A. An applicant for licensure as an athletic trainer shall: (1) Complete an application on a form supplied by the Board; (2) Pay an application fee as specified in Regulation .08 of this chapter; and (3) Submit all documentation which the Board requires to evaluate the application. B. To qualify, an applicant shall meet all of the following requirements: (1) Be 18 years old or older; (2) Be of good moral character; (3) Demonstrate oral and written competency in English by any of the following: (a) Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English; or (c) Receiving a grade of: (i) At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) At least 79 on the Internet-based Test of English as a Foreign Language; (4) Meet the following education requirements: (a) A bachelor’s or master’s degree from an accredited athletic training educational program; or (b) Exemption from the education requirement because the applicant: (i) Was certified by the certifying board on or before October 1, 2012; and (ii) Is in good standing with the certifying board at the time of the application; (5) Has passed the certification examination of the certifying board; and (6) Has been certified and maintains current certification from the certifying board at the time of application. #### Regulation .05 Scope of Practice. *COMAR 10.32.08.05* A. The scope of practice of an athletic trainer in the domain of injury prevention and wellness protection includes the following: (1) Minimization of risk of injury of athletes through awareness and education; (2) Monitoring of environmental conditions to facilitate individual and group safety of athletes; (3) Maintenance or enhancement of physical conditioning of athletes; and (4) Promotion of a healthy lifestyle of athletes using appropriate education and communication strategies to enhance wellness and minimize the risk of injury and illness. B. The scope of practice of an athletic trainer in the domain of clinical evaluation and assessment includes the following with respect to athletes: (1) Obtaining athlete’s health history through observation, interview, and records review; (2) Examining athlete’s body to assess the type and extent of the athletic injury; (3) Formulating a clinical assessment; and (4) Communicating information about the athletic injury to appropriate persons including the athlete. C. The scope of practice of an athletic trainer in the domain of immediate and emergency care includes the following with respect to athletes: (1) Immediate and emergency procedures including: (a) CPR; (b) Applying ice; (c) Splinting; (d) Elevation; (e) Pressure; (f) Bandaging for bleeding; (g) Proper immobilization of spine or other body parts; and (h) Dry needling; and (2) Making appropriate referrals so that the athlete will obtain appropriate follow-up. D. The scope of practice of an athletic trainer in the domain of treatment and rehabilitation includes the following activities, performed in an approved setting, with respect to athletes with athletic injuries: (1) Administering therapeutic and conditioning exercises as identified by the evaluation and treatment protocols of the supervising physician; (2) Administering therapeutic modalities as identified by the evaluation and treatment protocols of the supervising physician; (3) Applying braces, splints, or other assistive devices as identified by the evaluation and treatment protocols of the supervising physician; (4) Reassessing the status of injuries, illnesses, or conditions using appropriate techniques and documentation strategies to: (a) Determine appropriate treatment, rehabilitation, or reconditioning for injuries; and (b) Evaluate readiness to return to desired level of activity with respect to injuries, illnesses, or conditions; and (5) Administering dry needling therapy under the direction and guidance of a supervising physician who has training and experience in dry needling. E. The scope of practice of an athletic trainer in the domain of organization and management includes the following activities: (1) Maintenance of medical records with respect to all athletes who receive emergency care, assessment, or treatment; (2) Planning and organization of an athletic training program; and (3) Instructing others in prevention of and care for athletic injuries. F. The athletic trainer may accept an outside referral from a nonsupervising physician or licensed health care practitioner if: (1) The supervising physician specifies in the evaluation and treatment protocol that the athletic trainer may accept referrals from nonsupervising physicians or other licensed health care practitioners; (2) The nonsupervising physician or licensed health care practitioner has seen the athlete and has written an order for the care; and (3) The duties are: (a) Within the scope of practice of an athletic trainer; and (b) Among the duties delegated in the evaluation and treatment protocol. #### Regulation .06 Evaluation and Treatment Protocol. *COMAR 10.32.08.06* A. Contents. The evaluation and treatment protocol shall include the following: (1) Identification, licensure information, and signature of the: (a) Licensed athletic trainer; and (b) Licensed supervising physician; (2) Information about where the athletic trainer practices, including: (a) Addresses of the primary employer and supervising physician; and (b) Identification of the settings where the athletic trainer may practice; (3) Description of the supervision mechanism that applies to each setting; (4) Description of the delegated processes and procedures that the athletic trainer may use in each of the following areas: (a) Injury or illness prevention and wellness; (b) Clinical evaluation and assessment; (c) Immediate and emergency care; (d) Treatment, rehabilitation, and reconditioning; and (e) Organizational and professional well-being; (5) Descriptions of tasks which the athletic trainer may not perform; (6) Description of specialized tasks the supervising physician is delegating to the athletic trainer to perform with documentation of competencies, certification, credentials, or any other requirements established by the Board to support the delegation of the specialized tasks; (7) A statement of whether or not the supervising physician will permit the athletic trainer to accept outside referrals meeting the requirements stated in Regulation .05F of this chapter; (8) If applicable, the name and other relevant information about an alternate supervising physician; and (9) An attestation that states that the supervising physician will be responsible for providing ongoing and immediately available instruction that is adequate to ensure the safety and welfare of a patient and is appropriate to the setting. B. Process and Approval. (1) A licensed athletic trainer shall: (a) Submit an evaluation and treatment protocol on a form approved by the Board; and (b) Pay the fee as specified in Regulation .08 of this chapter. (2) A licensed athletic trainer may practice athletic training after receiving written approval from the Committee. (3) The Committee shall conditionally approve an evaluation and treatment protocol if: (a) The evaluation and treatment protocol does not include specialized tasks; or (b) The evaluation and treatment protocol includes specialized tasks that have been previously approved by the Board. (4) If an evaluation and treatment protocol includes a specialized task that has not been previously approved by the Board, the athletic trainer may perform the specialized task only after receiving written approval from the Board. (5) After consideration by the Committee, the Board shall either: (a) Approve the evaluation and treatment protocol and any specialized tasks; or (b) Disapprove the evaluation and treatment protocol or a specialized task if the Board determines that the evaluation and treatment protocol or specialized task does not meet the requirements in Health Occupations Article, §14-5D-11.3(b), Annotated Code of Maryland. (6) If the Board disapproves an evaluation and treatment protocol or a specialized task included in an evaluation and treatment protocol, the Board shall send written notice of the disapproval to the: (a) Primary supervising physician; and (b) Athletic trainer. (7) An athletic trainer who receives notice of a disapproval of an evaluation and treatment protocol from the Board shall immediately cease: (a) Practicing under the evaluation and treatment protocol; or (b) Performing the specialized task. (8) An individual member of the Board is not civilly liable for any act or omission relating to the approval, modification, or disapproval of an evaluation and treatment protocol. C. Termination of Evaluation and Treatment Protocol. (1) If the athletic trainer or the supervising physician terminates the evaluation and treatment protocol, the athletic trainer shall cease practicing until another evaluation and treatment protocol is approved by the Board. (2) The supervising physician shall report the termination of an evaluation and treatment protocol for any reason to the Board within 10 days of the termination and provide the following information: (a) Name and license number of supervising physician and athletic trainer; and (b) Reason for termination, including a description of conduct or incident that resulted in the termination. D. Emergency Evaluation and Treatment Protocol. In the event of a sudden departure, incapacity, or death of a supervising physician, a designated alternate may assume the role of the supervising physician by submitting a new evaluation and treatment protocol to the Board within 15 days. E. Dry Needling Protocol. (1) The practice of dry needling by a licensed athletic trainer shall require approval from the Board as a specialized task. (2) The Board shall issue approval to perform dry needling to a licensed athletic trainer who provides proof of completion of at least 80 hours of instruction in a continuing education course approved by: (a) The National Athletic Trainers’ Association; (b) The Board of Certification for the Athletic Trainer; or (c) The United States Armed Forces. (3) Course Requirements. (a) Of the 80 hours of instruction required under §E(2) of this regulation, at least 40 hours of instruction shall be in the following content areas: (i) Theory and application of dry needling; (ii) Dry needling technique, including spine and extremities; (iii) Dry needling indications and contraindications; (iv) Infection control, the Occupational Safety and Health Administration’s Bloodborne Pathogen Protocol, and safe handling of needles; (v) Emergency preparedness and response procedures related to complications associated with dry needling; and (vi) Appropriate documentation of dry needling. (b) Of the 80 hours of instruction required under §E(2) of this regulation, at least 40 hours shall be practical, hands-on instruction in the application and technique of dry needling that is completed under the guidance of a licensed health care practitioner who: (i) Is approved to perform dry needling; and (ii) Has practiced dry needling for at least 5 years. (4) The instruction required under §E of this regulation shall include an assessment of the licensed athletic trainer’s competency to perform dry needling that is performed by the instructor of the approved course. #### Regulation .07 Renewal, Reinstatement, Continuing Education, and Change in Name or Address. *COMAR 10.32.08.07* A. Renewal. (1) The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. (2) An individual who has been licensed by the Board as an athletic trainer may renew the license every 2 years on the date specified by the Board by: (a) Completing a renewal application on a form supplied by the Board; (b) Paying the required renewal fee specified in Regulation .08 of this chapter; (c) Attesting to the completion of at least 50 hours of approved continuing education credits, earned during the 2-year period preceding the expiration of the license for athletic training, in accordance with the requirements specified in §C of this regulation; and (d) Meeting any other requirement established by the Board. (3) The continuing education requirement applies to all renewal applications after the first renewal. B. Reinstatement. The Board shall reinstate the license of an athletic trainer if the athletic trainer: (1) Completes a reinstatement application on a form supplied by the Board; (2) Pays the required reinstatement fee and any other fees specified in Regulation .08 of this chapter; (3) Documents evidence of at least 50 hours of approved continuing education credits during the 2-year period preceding the date of the submission of the application for reinstatement; (4) Meets any additional requirements set by the Board for reinstatement of a license; and (5) Is currently registered with the certifying board. C. Continuing Education. (1) The following activities are approved continuing education experiences: (a) Programs presented by providers approved by the certifying board; (b) Professional development activities approved by the certifying board; and (c) Courses offered for undergraduate or graduate degree credit by colleges or universities. (2) Documentation. (a) An athletic trainer shall obtain documentation of completion of continuing education and retain the documentation for 4 years. (b) The documentation for a program provided by a provider approved by the certifying board shall contain, at a minimum, the following information: (i) Program title; (ii) Sponsor’s name; (iii) Athletic trainer’s name; (iv) Inclusive date or dates and location of the program; (v) Number of continuing education hours earned; and (vi) Documented verification that the athletic trainer attended the program by stamp, signature, printout, or other official proof. (c) Documentation for professional development activities shall be as specified by the certifying board. (d) Documentation of credits earned through college or university courses shall be an official transcript from the college or university. (3) Proof of maintenance of certification by the certifying board may be used to document compliance with the continuing education requirement. D. Change in Name or Address. (1) A licensee shall notify the Board in writing of a change in name or address within 60 days after the change. (2) Licensees who fail to notify the Board of name or address changes as required by §D(1) of this regulation are subject to an administrative penalty of $100. #### Regulation .08 Fees. *COMAR 10.32.08.08* The following fees are applicable to athletic trainers. A. Initial licensure fee — $200; B. License renewal fees: (1) License renewal fee — $135; and (2) Maryland Health Care Commission (MHCC) fee — as determined by MHCC under COMAR 10.25.03; C. Reinstatement fee — $200; D. Evaluation and treatment protocol — $100; E. Written verification fee — $25; and F. Replacement of license fee — $25. #### Regulation .09 Prohibited Conduct. *COMAR 10.32.08.09* A. Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, the Board may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee: (1) Fraudulently or deceptively obtains or attempts to obtain a license for the applicant, for the licensee, or for another; (2) Fraudulently or deceptively uses a license; (3) Is guilty of unprofessional or immoral conduct in the practice of athletic training; (4) Is professionally, physically, or mentally incompetent; (5) Abandons a patient; (6) Habitually is intoxicated; (7) Is addicted to, or habitually abuses, any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; (8) Provides professional services while: (a) Under the influence of alcohol; or (b) Using: (i) Any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; or (ii) Any other drug that is in excess of therapeutic amounts or without valid medical indication; (9) Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain; (10) Willfully makes or files a false report or record in the practice of athletic training; (11) Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report; (12) Breaches patient confidentiality; (13) Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient; (14) Knowingly makes a misrepresentation while practicing athletic training; (15) Knowingly practices athletic training with an unauthorized individual or aids an unauthorized individual in the practice of athletic trainer services; (16) Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine; (17) Is disciplined by a licensing, certifying, or disciplinary authority or is convicted or disciplined by a court of any state or country or is disciplined by any branch of the United States uniformed services or the Veterans Administration for an act that would be grounds for disciplinary action under Health Occupations Article, §15-5D-14, Annotated Code of Maryland; (18) Fails to meet appropriate standards for delivery of athletic training services; (19) Knowingly submits false statements to collect fees for which services have not been provided; (20) Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes and the licensed individual: (a) Surrendered the license issued by the state or country; or (b) Allowed the license issued by the state or country to expire or lapse; (21) Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (22) Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes; (23) Practices or attempts to practice beyond the authorized scope of practice; (24) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; (25) Practices or attempts to practice an athletic training procedure or uses or attempts to use athletic training equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment; (26) Fails to cooperate with a lawful investigation conducted by the Board; (27) Fails to practice under the supervision of a physician or violates the approved evaluation and treatment protocol; (28) Violates an order of the Board, including any condition of probation; or (29) Performs dry needling without the approval of the Board issued under Regulation .06E of this chapter. B. Crimes of Moral Turpitude. (1) On the filing of certified docket entries with the Board by the Office of the Attorney General, the Board shall order the suspension of a license if the licensee is convicted of or pleads guilty or nolo contendere with respect to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. (2) After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a license on the certification by the Office of the Attorney General. #### Regulation .10 Investigations, Hearings, and Appeals. *COMAR 10.32.08.10* A. Complaints alleging prohibited conduct shall be referred to the Board to be investigated according to the Board’s procedures. B. A hearing on charges issued under Regulation .09A of this chapter or Health Occupations Article, §14-5D-14(a), Annotated Code of Maryland, shall be held in accordance with the hearing provisions of Health Occupations Article, §§14-405 and 14-5D-15, Annotated Code of Maryland. C. Proceedings for crimes of moral turpitude, under Health Occupations Article, §14-5D-14(b), Annotated Code of Maryland, or Regulation .09B of this chapter shall be held in accordance with COMAR 10.32.02.08. D. All other hearings shall be held in accordance with the Administrative Procedure Act. E. Appeals from a final Board decision shall be taken in accordance with Health Occupations Article, §14-5D-15, Annotated Code of Maryland. #### Regulation .11 Fines, Penalties, and Sanctioning Guidelines. *COMAR 10.32.08.11* A. An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5D, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000, or imprisonment not exceeding 1 year, or both. B. The Board may impose a civil fine of not more than $5,000 on an individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5D, Annotated Code of Maryland. C. The Board shall deposit a penalty collected under §B of this regulation into the Board of Physicians fund. D. General Application of Sanctioning Guidelines. (1) Sections D and E of this regulation and Regulation .12 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §E of this regulation, for violations of the sections of the Maryland Athletic Trainers Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation. (c) A stayed suspension not meeting the criteria for §D(3)(b) of this regulation is ranked as a reprimand. (d) A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction. (e) The addition of a fine does not change the ranking of the severity of the sanction. (4) The Board may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking should be used to determine which ground will be used in developing a sanction; and (b) The Board may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .12 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the Board, the administrative prosecutor, and the licensee. (8) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §E(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (9) If the Board imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .12 of this chapter, the Board shall state its reasons for doing so in its final decision and order. E. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §E(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. (3) The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (4) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the Board and was cooperative during the Board proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (5) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified or destroyed evidence or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. (6) A departure from the sanctioning guidelines set forth in Regulation .12 of this chapter is not a ground for any hearing or appeal of a Board action. F. Offenses Related to Continuing Medical Education Credits. (1) First Offense of Failure to Document Credits. (a) Except as provided in §F(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §14-5D-12, Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-5D-14, Annotated Code of Maryland. (b) Section F(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits. (2) Willful Falsification. (a) If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5D-14(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5D-14(a)(10), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-5D-14(a)(11), Annotated Code of Maryland. (b) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5D-14, Annotated Code of Maryland, and the sanctioning guidelines. (3) Licensees Previously Disciplined Under §I(1) or (2) of this regulation. (a) If a licensee has been previously fined or otherwise disciplined under §F(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5D-14(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5D-14(a)(10), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-5D-14(a)(11), Annotated Code of Maryland. (b) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5D-14, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense. (c) The Board may not apply the sanction described in §F(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits. (4) The Board shall pay all monies collected pursuant to this section into the Board of Physicians Fund. G. Payment of Fines. (1) An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise. (2) Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation. (3) If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full. (4) In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. #### Regulation .12 Sanctioning Guidelines for Athletic Trainers. *COMAR 10.32.08.12* A. Subject to provisions of Regulation .11D—E of this chapter, the Board may impose sanctions as outlined in §B of this regulation on athletic trainers for violations of Health Occupations Article, §14-5D-14, Annotated Code of Maryland. B. Range of Sanctions. ### Chapter 09 — Delegation and Assignment of Performance of Cosmetic Medical Procedures and Use of Cosmetic Medical Devices **Authority:** Health Occupations Article, §§14-205, 14-306, 14-404, 14-606, and 15-302, Annotated Code of Maryland **Administrative History:** Effective date: August 23, 2010 (37:17 Md. R. 1185) **Administrative History:** Regulation .02B amended effective March 14, 2016 (43:5 Md. R. 386); December 31, 2018 (45:26 Md. R. 1246) #### Regulation .01 Scope. *COMAR 10.32.09.01* A. This chapter governs the performance, delegation, assignment, and supervision of cosmetic medical procedures, and the use of cosmetic medical devices by a physician or under a physician's direction. B. This chapter does not govern use of medical procedures or medical devices for the purpose of treating a disease. C. This chapter does not endorse or certify the safety of any cosmetic medical device or cosmetic medical procedure. D. This chapter does not authorize the delegation of any duties to any person who is not licensed under Health Occupations Article, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.32.09.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ACCME” means the Accreditation Council on Continuing Medical Education. (2) “ACGME” means the Accreditation Council for Graduate Medical Education. (3) “AOA” means the American Osteopathic Association. (4) Cosmetic Medical Device. (a) “Cosmetic medical device” means a device that alters or damages living tissue. (b) “Cosmetic medical device” includes any of the following items, when the item is used for cosmetic purposes: (i) Laser; (ii) Device emitting light or intense pulsed light; (iii) Device emitting radio frequency, electric pulses, or sound waves; and (iv) Devices used for the injection or insertion of foreign or natural substances into the skin, fat, facial tissue, muscle, or bone. (5) Cosmetic Medical Procedure. (a) “Cosmetic medical procedure” means a procedure using a cosmetic medical device or medical product to improve an individual's appearance. (b) “Cosmetic medical procedure” includes the following: (i) Skin treatments using lasers; (ii) Skin treatments using intense pulsed light; (iii) Skin treatments using radio frequencies, microwave, or electric pulses; (iv) Chemical peels that ablate living skin tissue; (v) Skin treatments with phototherapy; (vi) Dermabrasion; (vii) Subcutaneous, intradermal, or intramuscular injections of medical products; (viii) Treatments intended to remove or cause destruction of fat; and (ix) Any treatment using a cosmetic medical device for the purpose of improving an individual's appearance. (6) “Delegate” means to entrust a duty to a physician assistant under Health Occupations Article, Title 15, Annotated Code of Maryland. (7) “Delegation” means the entrusting of a duty by a physician to a physician assistant under Health Occupations Article, Title 15, Annotated Code of Maryland. (8) “Dermabrasion” means an abrasive process to remove epidermis and superficial dermis, resulting in a smoothing of contour irregularities. (9) “Direct supervision” means oversight exercised by a supervising physician who is: (a) In the physical presence of a non-physician and a patient; and (b) Instructing the non-physician in the performance of a cosmetic medical procedure, or observing the performance of a non-physician being trained in the procedure. (10) “Immediately available supervision” means the responsibility of a licensed physician to provide necessary direction in person, by telephone, or by other electronic means. (11) “Non-Physician” means an individual who: (a) Meets the requirements of Regulation .04 of this chapter; and (b) Is not licensed in Maryland as a physician. (12) “On-site supervision” means oversight exercised by a supervising physician who is: (a) Present at the site; and (b) Able to respond in person during a delegated or assigned cosmetic medical procedure. (13) “Physician assistant” means a physician assistant with a current certificate to practice in Maryland. #### Regulation .03 Physician Qualifications. *COMAR 10.32.09.03* A. License. A physician shall obtain a license to practice medicine in Maryland before the physician may perform, delegate, assign, or supervise cosmetic medical procedures or the use of cosmetic medical devices. B. Education. (1) A physician who performs, assigns, supervises, or delegates the performance of cosmetic medical procedures by a non-physician first shall obtain training in the indications for and performance of the cosmetic medical procedures and operation of any cosmetic medical device to be used. (2) Training programs provided by a manufacturer or vendor of cosmetic medical devices or supplies may not be a physician's only education in the cosmetic medical procedures or the operation of the cosmetic medical devices to be used. (3) ACCME or AOA approved continuing education, or completion of an ACGME or AOA accredited postgraduate program that includes training in the cosmetic medical procedure performed satisfies this requirement. #### Regulation .04 Qualifications of Individual to Whom Acts May Be Delegated and Assigned. *COMAR 10.32.09.04* A. A cosmetic medical procedure may be delegated to a physician assistant or assigned to any other health care provider licensed under Health Occupations Article, Annotated Code of Maryland, whose licensing board has determined that the procedure falls within the provider's scope of practice. B. A physician may not permit any individual who performs cosmetic medical procedures delegated or assigned by that physician to operate a cosmetic medical device or perform a cosmetic medical procedure unless the individual has received: (1) Training as described in Regulation .07 of this chapter; and (2) Any training required by that individual's health occupations board. #### Regulation .05 Physician Responsibilities. *COMAR 10.32.09.05* A. A physician shall: (1) Develop and maintain at each site where the delegated, assigned, or supervised cosmetic medical procedures will be rendered written office protocols for each such cosmetic medical procedure; (2) Personally perform the initial assessment of each patient; (3) Prepare a written treatment plan for each patient, including diagnosis and planned course of treatment and specification of the device and device settings to be used; (4) Obtain informed consent of the patient to be treated by a non-physician; (5) Except as indicated in §B or C of this regulation, provide onsite supervision whenever a non-physician is performing cosmetic medical procedures or using cosmetic medical devices; (6) Retain responsibility for any acts delegated to a non-physician; and (7) Create and maintain medical records in a manner consistent with accepted medical practice and in compliance with Health-General Article, Title 4, Subtitles 3 and 4, Annotated Code of Maryland, and with Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §1320d-2, as amended, and 45 CFR Parts 160 and 164, as amended). B. The Board may approve a delegation agreement for a physician assistant that permits the physician to delegate performance of cosmetic medical procedures under immediately available supervision after the physician has evaluated the patient and developed a written treatment plan. C. A delegation agreement for a physician assistant that includes cosmetic medical procedures and is approved by the Board before May 2009, is not affected by this chapter. #### Regulation .06 Written Protocols. *COMAR 10.32.09.06* Written protocols for cosmetic medical procedures and equipment shall include the following: A. List of all equipment, including: (1) Manufacturer's specifications; (2) Operating instructions; and (3) Maintenance log; B. Documentation regarding initial and periodic training of all users of the equipment; C. Role of the physician for each procedure; D. Role of the non-physician for each procedure; E. Steps to address common complications and emergency situations; and F. Appropriate care and follow-up for the patient after the procedure. #### Regulation .07 Training of Non-Physicians. *COMAR 10.32.09.07* A. The physician is responsible for assuring that any individual to whom the physician delegates or assigns the performance of a cosmetic medical procedure or the operation of a cosmetic medical device is properly trained. Training shall include both theoretical instruction and clinical instruction. B. Theoretical instruction shall include: (1) Cosmetic-dermatological indications and contraindications for treatment; (2) Identification of realistic and expected outcomes of each procedure; (3) Selection, maintenance, and utilization of equipment; (4) Appropriate technique for each procedure, including infection control and safety precautions; (5) Pharmacological intervention specific to the procedure; (6) Identification of complications and adverse reactions for each procedure; (7) Emergency procedures to be used in the event of: (a) Complications; (b) Adverse reactions; (c) Equipment malfunction; or (d) Any other interruption of a procedure; and (8) Appropriate documentation of the procedure in the patient's chart. C. Clinical instruction shall include: (1) Observation of performance of the procedure or use of the device by an individual experienced in performing the procedure; and (2) Performing the procedure or using the device under the direct supervision of the delegating physician who is present and observing the procedure a sufficient number of times to assure that the non-physician is competent to perform the procedure without direct supervision. #### Regulation .08 Non-Physician's Responsibility. *COMAR 10.32.09.08* A. A physician who delegates or assigns a cosmetic medical procedure or the use of a cosmetic medical device to a non-physician or who supervises a non-physician performing these functions shall assure that the non-physician complies with this regulation. B. A non-physician may not use a cosmetic medical device or perform a cosmetic medical procedure unless the individual has received: (1) The training described in Regulation .07 of this chapter; and (2) Any training required by that individual's health occupations board. C. A non-physician shall: (1) Review and follow the written protocol with respect to a cosmetic medical procedure; (2) Verify that the physician has assessed the patient and given written treatment instructions for the procedure; (3) Discuss the procedure with the patient to ensure that the patient: (a) Is aware that the treatment will be provided by a non-physician; and (b) Has given consent in writing to treatment by a non-physician; (4) Notify the delegating physician about any adverse events or complications before the patient leaves the site; (5) Document all relevant details of the procedure in the patient's chart, including any adverse events and complications; and (6) Satisfy any requirements imposed by the licensing board of the non-physician. #### Regulation .09 Grounds for Discipline. *COMAR 10.32.09.09* A. Physician. A physician may be disciplined for any of the following: (1) Delegating, assigning, or supervising a cosmetic medical procedure performed by an individual who is not a physician assistant or another licensed health care provider whose licensing board has determined that the procedure is within the scope of practice of the individual; (2) Delegating cosmetic medical procedures to an individual who has not had: (a) The training specified in Regulation .07 of this chapter; and (b) The training required by that individual's health occupations board; or (3) Failure to adhere to any requirement of this chapter. B. Non-Physician. A non-physician who violates any provision of this chapter is guilty of the practice of medicine without a license and may be subject to a fine of not more than $50,000 under Health Occupations Article, §14-606, Annotated Code of Maryland. C. Other Individual. An individual using a cosmetic medical device or performing a cosmetic medical procedure who is not a licensed physician and is not authorized to perform the cosmetic medical procedure under this chapter, or under regulations promulgated by another licensing board established by Health Occupations Article, Annotated Code of Maryland, is guilty of the practice of medicine without a license and may be subject to a fine of not more than $50,000 under Health Occupations Article, §14-606, Annotated Code of Maryland. ### Chapter 10 — Licensure of Radiation Therapists, Radiographers, Nuclear Medicine Technologists, and Radiologist Assistants **Authority:** Health Occupations Article, §§1-213, 1-606, 14-306, 14-5B-01, and 14-5B-03—14-5B-21, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.12 adopted as an emergency provision effective February 16, 1990 (17:6 Md. R. 735); emergency status extended at 17:17 Md. R. 2076 and 18:3 Md. R. 301; emergency status expired July 1, 1991 **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective July 2, 1991 (18:14 Md. R. 1607); emergency status expired January 1, 1992 **Administrative History:** Regulations .01—.11 adopted effective January 2, 1992 (18:21 Md. R. 2308) **Administrative History:** Regulation .01 amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .02B amended effective May 8, 1995 (22:9 Md. R. 645); March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .03 amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .04C amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .05 repealed effective May 8, 1995 (22:9 Md. R. 645) **Administrative History:** Regulation .06 amended effective December 18, 1995 (22:25 Md. R. 1962); March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .06 repealed and new Regulation .06 adopted as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); adopted permanently effective November 3, 2008 (35:22 Md. R. 1957) **Administrative History:** Regulation .07 amended effective May 8, 1995 (22:9 Md. R. 645) **Administrative History:** Regulation .07 repealed and new Regulation .07 adopted effective December 2, 1996 (23:24 Md. R. 1682) **Administrative History:** Regulation .07 amended effective March 1, 2004 (31:4 Md. R. 316); June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .08 amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .08 repealed effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .09 amended effective September 11, 1995 (22:18 Md. R. 1400); May 19, 1997 (24:10 Md. R. 710) **Administrative History:** Regulation .09 amended as an emergency provision effective February 13, 2003 (30:5 Md. R. 363); amended permanently effective March 31, 2003 (30:6 Md. R. 420) **Administrative History:** Regulation .10A, B amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .11 amended effective August 19, 2002 (29:16 Md. R. 1288); March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .12 adopted effective August 19, 2002 (29:16 Md. R. 1288) **Administrative History:** Regulation .12A amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .13 adopted effective August 19, 2002 (29:16 Md. R. 1288) **Administrative History:** Regulation .13 amended effective March 1, 2004 (31:4 Md. R. 316) **Administrative History:** Regulation .14 adopted as an emergency provision effective February 13, 2003 (30:5 Md. R. 363); adopted permanently effective March 31, 2003 (30:6 Md. R. 420) **Administrative History:** Chapter revised effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .01B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .02B amended effective May 12, 2014 (41:9 Md. R. 521); December 30, 2019 (46:26 Md. R. 1165); January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .04 amended effective December 27, 2010 (37:26 Md. R. 1788) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted effective December 22, 2014 (41:25 Md. R. 1485) **Administrative History:** Regulation .04B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .05 adopted effective December 22, 2014 (41:25 Md. R. 1485) **Administrative History:** Regulation .05B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .05-1 adopted effective December 22, 2014 (41:25 Md. R. 1485) **Administrative History:** Regulation .05-1B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .05-2 adopted effective December 22, 2014 (41:25 Md. R. 1485) **Administrative History:** Regulation .05-2B, C amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .06 repealed effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .07A, B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .07C amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .08C amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .09C adopted effective March 2, 2015 (42:4 Md. R. 433) **Administrative History:** Regulation .10 amended effective December 30, 2019 (46:26 Md. R. 1165) **Administrative History:** Regulation .10A amended effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulation .10C amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .11 amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .12 amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .13 amended effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .14A, B amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .16 amended effective July 22, 2013 (40:14 Md. R. 1176) **Administrative History:** Regulation .18 amended effective May 12, 2014 (41:9 Md. R. 521) **Administrative History:** Regulation .19 adopted effective July 22, 2013 (40:14 Md. R. 1176) **Administrative History:** Regulation .19B amended effective May 12, 2014 (41:9 Md. R. 521) #### Regulation .01 Scope. *COMAR 10.32.10.01* A. This chapter governs the practice of radiation therapy, radiography, nuclear medicine technology, and radiology assistance. B. This chapter does not prohibit: (1) A radiation therapy, radiography, nuclear medicine technology, or radiology assistance student enrolled in an educational program from practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance in the educational program; (2) An individual employed by the federal government as a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant from practicing within the scope of that employment; or (3) An individual from practicing a health occupation that the individual is authorized to practice under the Health Occupations Article. #### Regulation .02 Definitions. *COMAR 10.32.10.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ARRT” means the American Registry of Radiologic Technologists. (2) “Board” means the Board of Physicians. (3) “Certification” means recognition of an individual who has satisfied certain standards required by a national certifying board. (4) “Committee” means the Radiation Therapy, Radiography, Nuclear Medicine Technology, and Radiology Assistance Advisory Committee of the Board. (5) “Computed tomography (CT)” means the use of a machine that produces ionizing radiation to obtain cross-sectional images. (6) Direct Supervision. (a) “Direct supervision” means supervision by a licensed physician who is: (i) In the physical presence of the licensee and a patient; and (ii) Observing and directing the licensee as the licensee performs a procedure. (b) “Direct supervision” includes, for purposes of meeting the examination eligibility requirements set out in Regulation .10B of this chapter, supervision by a: (i) Licensed nuclear medicine technologist with the post-primary computed tomography (CT) credential; (ii) Licensed radiographer with the post-primary CT credential; or (iii) Licensed radiologist or radiation oncologist. (7) “Hybrid nuclear medicine/CT device” means a machine that combines two distinct imaging modalities. (8) “Immediately available direction” means the responsibility of a licensed physician to provide necessary direction for a licensee in person, by telephone, or by other electronic means if the licensee needs assistance with a procedure. (9) “JRCNMT” means the Joint Review Committee on Educational Programs in Nuclear Medicine Technology. (10) “Licensee” means an individual who is licensed to practice radiography, radiation therapy, nuclear medicine technology, or radiology assistance in Maryland. (11) “NMTCB” means the Nuclear Medicine Technology Certification Board. (12) “Nuclear medicine technologist” means an individual licensed by the Board to practice nuclear medicine technology. (13) “On-site supervision” means the responsibility of a licensed physician to provide necessary direction for a licensee when the physician is: (a) Physically present in the facility; and (b) Able to respond in person if the licensee needs assistance with a procedure. (14) “Physician” means an individual who is licensed by the Board to practice medicine. (15) “Post–primary computed tomography (CT) credential” means passing a specialty examination by the ARRT or the NMTCB to establish competency in performing computed tomography. (16) “Practice nuclear medicine technology” means to: (a) Prepare and administer radiopharmaceuticals to human beings; or (b) Conduct in vivo detection and measurement of radioactivity for medical purposes to assist the physician in the diagnosis and treatment of disease or injury. (17) “Practice radiation therapy” means to perform tumor localization radiography and apply therapeutic doses of radiation for the treatment of disease or injury. (18) “Practice radiography” means to use ionizing radiation to: (a) Demonstrate portions of the human body to assist the physician in the diagnosis of disease or injury; or (b) Perform tumor localization radiography. (19) “Practice radiology assistance” means to: (a) Practice radiography; and (b) Perform: (i) Fluoroscopy and selected radiology procedures; (ii) Patient assessment; and (iii) Patient management. (20) “Radiation therapist” means an individual licensed by the Board to practice radiation therapy. (21) “Radiographer” means an individual who is licensed by the Board to practice radiography. (22) “Radiologist” means a licensed physician who: (a) Specializes in radiology; and (b) Has current certification in radiology by one of the following organizations: (i) American Board of Radiology; (ii) American Osteopathic Board of Radiology; (iii) British Royal College of Radiology; or (iv) Royal College of Physicians and Surgeons of Canada. (23) “Special procedure request” means a written request to the Board to allow a licensed radiologist assistant to perform one or more procedures listed in Regulation .11E of this chapter. (24) “Supervision” means the responsibility of the licensed physician to exercise on-site direction or immediately available direction for licensees. #### Regulation .03 Committee. *COMAR 10.32.10.03* A. The Board shall establish a Committee composed of the following individuals: (1) One physician whose approved specialty is radiology; (2) One physician whose approved specialty is nuclear medicine; (3) One physician whose approved specialty is radiation oncology; (4) One physician who specializes in radiology and who supervises a radiologist assistant; (5) One radiographer; (6) One radiation therapist; (7) One nuclear medicine technologist; (8) One radiologist assistant; (9) One consumer member; and (10) One Board member. B. Selection. (1) The physician whose specialty is radiology, the physician whose specialty is radiation oncology, and the physician who specializes in radiology and supervises a radiologist assistant may be selected by the Board from a list of nominees submitted by the American College of Radiology—Maryland Chapter. Nominees are not required to be members of the American College of Radiology. (2) The physician whose specialty is nuclear medicine may be selected by the Board from a list of nominees submitted by the Mideastern Chapter—Society of Nuclear Medicine. Nominees are not required to be members of the Mideastern Chapter—Society of Nuclear Medicine. (3) The radiographer and the radiation therapist may be selected by the Board from a list of nominees submitted by the Maryland Society of Radiologic Technologists. Nominees are not required to be members of the Maryland Society of Radiologic Technologists. (4) The nuclear medicine technologist may be selected by the Board from a list of nominees submitted by the Mideastern Chapter—Society of Nuclear Medicine —Technologist Section. Nominees are not required to be members of the Mideastern Chapter—Society of Nuclear Medicine—Technologist Section. (5) The consumer member shall: (a) Meet the requirements in Health Occupations Article, §14-5B-05(d), Annotated Code of Maryland; and (b) Be selected by the Board. C. Tenure. (1) The term of a member is 3 years. (2) The terms of the members are staggered. (3) At the end of a term, a member continues to serve until a successor is appointed. (4) An individual may be reappointed for a second term but the individual may not serve more than two full consecutive terms. D. Vacancy. (1) If a vacancy occurs as to a member, the Board shall appoint a new member to serve, as provided in this regulation. (2) The successor member shall only serve for the remainder of the term, unless reappointed. E. The Committee shall elect a chair from among its members once every 2 years. F. The Committee shall: (1) Review selected applications for licensure of radiographers, nuclear medicine technologists, radiation therapists, and radiologist assistants, and make recommendations to the Board for approval; (2) Make recommendations to the Board regarding regulations governing radiographers, nuclear medicine technologists, radiation therapists, and radiologist assistants; (3) Make recommendations to the Board on the requirements for licensure of radiographers, radiation therapists, nuclear medicine technologists, and radiologist assistants; (4) Make recommendations to the Board on a code of ethics for the practice of radiography, radiation therapy, nuclear medicine technology, and radiology assistance; (5) Advise the Board on matters related to standards of care for the practice of radiography, nuclear medicine technology, radiation therapy, and radiology assistance; (6) Advise the Board on matters related to the practice of radiography, nuclear medicine technology, radiation therapy, and radiology assistance; and (7) Keep a record of the Committee's proceedings. #### Regulation .04 Qualifications for Licensure — Radiographer. *COMAR 10.32.10.04* A. An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation. B. An individual shall be licensed by the Board if the individual: (1) Completes an application on a form supplied by the Board; (2) Pays an application fee as specified in Regulation .18 of this chapter; (3) Is 18 years old or older; (4) Is of good moral character; (5) Demonstrates oral and written competency in English by any of the following: (a) Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English; (c) Receiving a grade of: (i) At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) At least 79 on the Internet-based Test of English as a Foreign Language; (6) Has successfully completed and graduated from a radiographer educational program that is recognized by the ARRT or its successor; (7) Has passed the examination in radiography constructed by the ARRT or its successor; and (8) Has been certified and maintains current registration or active certification from the ARRT or its successor, at the time of application. #### Regulation .05 Qualifications for Licensure — Nuclear Medicine Technologist. *COMAR 10.32.10.05* A. An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation. B. An individual shall be licensed by the Board if the individual: (1) Completes an application on a form supplied by the Board; (2) Pays an application fee as specified in Regulation .18 of this chapter; (3) Is 18 years old or older; (4) Is of good moral character; (5) Demonstrates oral and written competency in English by any of the following: (a) Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English; (c) Receiving a grade of: (i) At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) At least 79 on the Internet-based Test of English as a Foreign Language; (6) Has successfully completed and graduated from a nuclear medicine educational program that is recognized by the ARRT or its successor, or the NMTCB or its successor; (7) Has passed the examination in nuclear medicine technology constructed by the ARRT or its successor, or the NMTCB or its successor; and (8) Has been certified and maintains current registration or active certification from the ARRT or its successor, or the NMTCB or its successor at the time of application. #### Regulation .05-1 Qualifications for Licensure — Radiation Therapists. *COMAR 10.32.10.05-1* A. An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation. B. An individual shall be licensed by the Board if the individual: (1) Completes an application on a form supplied by the Board; (2) Pays an application fee as specified in Regulation .18 of this chapter; (3) Is 18 years old or older; (4) Is of good moral character; (5) Demonstrates oral and written competency in English by any of the following: (a) Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English; (c) Receiving a grade of: (i) At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) At least 79 on the Internet-based Test of English as a Foreign Language; (6) Has successfully completed and graduated from a radiation therapy educational program that is recognized by the ARRT or its successor; (7) Has passed the examination in radiation therapy constructed by the AART or its successor; and (8) Has been certified and maintains current registration or active certification from the AART or its successor at the time of application. #### Regulation .05-2 Qualifications for Licensure — Radiologist Assistants. *COMAR 10.32.10.05-2* A. An individual shall be licensed by the Board if the individual meets the requirements of §B of this regulation. B. An individual shall be licensed by the Board if the individual: (1) Completes an application on a form supplied by the Board; (2) Pays an application fee as specified in Regulation .18 of this chapter; (3) Is 18 years old or older; (4) Is of good moral character; (5) Demonstrates oral and written competency in English by any of the following: (a) Graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Graduation from a recognized English-speaking professional school with acceptable proof of proficiency in the oral and written communication of English; or (c) Receiving a grade of: (i) At least 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) At least 79 on the Internet-based Test of English as a Foreign Language; (6) Has been educated as follows: (a) Completed a radiologist assistant educational program that is recognized by the ARRT or its successor; and (b) Successfully completed coursework that leads to a baccalaureate degree or post-baccalaureate certificate; (7) Has passed the examination administered by the ARRT or its successor; and (8) Has been certified and maintains current registration or active certification from the ARRT or its successor at the time of application. C. In addition to the requirements specified in §B of this regulation, an applicant for a license as a radiologist assistant shall have: (1) A current Maryland license as a radiographer; (2) Completed a radiologist or radiation oncologist-directed clinical preceptorship as a part of the educational program required by §B(6) of this regulation; (3) Current certification in advanced cardiac life support; and (4) Current certification as a radiologist assistant by the ARRT or its successor. #### Regulation .06 Temporary Licensure — Repealed. *COMAR 10.32.10.06* #### Regulation .07 Scope of Practice — General. *COMAR 10.32.10.07* A. Supervision. (1) A radiation therapist, radiographer, or a nuclear medicine technologist may practice only under the supervision of a licensed physician. (2) A licensed radiologist assistant may practice only under the supervision of a licensed radiologist or radiation oncologist. B. Administration of Medications or Contrast Media. (1) A radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant may initiate an intravenous line and administer contrast media with the following supervision: (a) A radiologist assistant may administer contrast media under the immediately available direction of a radiologist or radiation oncologist; and (b) A radiation therapist, radiographer, or nuclear medicine technologist may administer contrast media after consultation with a physician who is physically available on the premises. (2) A radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant may not administer narcotic or sedating medication. C. Identification. A radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant, when practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance shall wear a badge which identifies the individual wearing the badge to be a licensed radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant. #### Regulation .08 Scope of Practice — Radiation Therapy. *COMAR 10.32.10.08* The practice of radiation therapy includes the following: A. Scope of practice for simulation procedures and for operation of external beam treatment devices, CT simulator, and fluoroscopic simulator for patient therapy which includes: (1) Preparation of machine for patient procedure; (2) Positioning patient for treatment or localization, or both; (3) Adjustment of machine components and systems; (4) Application of machine adjustments while patient is on the table; (5) Attachment or removal of any machine device or machine accessory for patient service, or both; (6) Manipulation of machine controls for patient exposure for localization or treatment, or both; (7) Production of radiation for tumor or field localization on, or treatment of, a patient, or both; (8) Documentation of technical set up used on a patient; (9) Monitoring of patient and equipment during the simulation or treatment procedures for application of corrective actions; (10) Oversight and application of image development standards and appropriate labeling of images regarding patient identification, date, and documentation of technical parameters; (11) Performance of patient or image measurements, or both; (12) Application of technical procedures in accordance with accepted radiation safety standards and regulations; (13) Performance of dosimetric and geometric calculations related to patient treatment; and (14) Manipulation, data entry, or other use of computer-accelerator interfaced hardware or software for patient treatment; B. Scope of practice for preparation of patient treatment devices which includes: (1) Oversight of in-facility manufacture of devices or device accessories for use in patient treatment; and (2) Approval of devices for use in patient simulation and treatment; C. Scope of practice for brachytherapy and radiopharmaceutical procedures which includes: (1) Removal, return, or handling of radiation sources or medical applicators, or both, containing radioactive material; (2) Transportation of radioactive materials; (3) Documentation for the accountability and use of the radiation sources; (4) Insertion and removal of sources from medical applicators; (5) Preparation of sealed radiopharmaceuticals for therapeutic administration to patients under physician supervision; (6) Assisting the licensed physician in the preparation and administration of sealed therapeutic radiopharmaceuticals for brachytherapy; (7) Documentation of the therapeutic application of radiopharmaceuticals; (8) Oversight of radiation safety practices related to the handling and administration of radiopharmaceuticals for therapy of patients; (9) Management of transportation and handling of therapeutic radiopharmaceuticals, immediate management and appropriate notifications for any spills or other accidents involving radiopharmaceuticals; (10) Calibration of therapeutic radiopharmaceuticals for dose accuracy; and (11) Preparation of unsealed radiopharmaceuticals for therapeutic administration to patients under direct supervision by a licensed physician if the radiation therapist has received on-site training from an authorized user; and D. Performance of any other duties that the Board determines may be performed by a radiation therapist. #### Regulation .09 Scope of Practice — Radiography. *COMAR 10.32.10.09* A. The scope of practice of radiography includes the following: (1) Analysis and correlation of procedure requests and clinical information provided by a physician or patient, or both, for preprocedure determination of the appropriate exam, its extent, and its scope; (2) Evaluation of the physical and emotional status of the patient with respect to the ability to undergo the procedure requested; (3) Selection, preparation, and operation of radiography equipment and accessories to perform procedures; (4) Positioning patient to best demonstrate anatomy of interest, while respecting patient's physical limitations and comfort; (5) Determination of radiographic exposure factors, setting of factors on control panel, and application of x-ray exposures; (6) Application of radiation protection principles to minimize radiation exposure to patient, self, and others; (7) Evaluation of images for technical quality; (8) Performance of noninterpretive fluoroscopic procedures according to institutional policy; (9) Oversight of image processing standards and the appropriate labeling of images; (10) Administering contrast media after consultation with, and under the supervision of, a physician who is immediately and physically available; and (11) Performing any other duties that the Board determines may be performed by a radiographer. B. The scope of practice of radiography includes the administration of intravenous medications and other patient care procedures as directed by the physician if the: (1) Radiographer is: (a) Registered by the ARRT in advanced qualifications in cardiac-interventional radiography, vascular-interventional radiography, or cardiovascular-interventional radiography; (b) Working in a cardiac catheterization laboratory or interventional radiographic laboratory while cardiac catheterization or interventional procedures are ongoing; and (c) Administering the medication or performing a patient care procedure at the direction of a physician while the physician is present in the room directing the administration and dosage of medication or performance of the patient care procedure; (2) Supervising physician in the cardiac catheterization or interventional laboratory is responsible for the acts of the radiographer when delegating the administration of intravenous medications or performance of a patient care procedure; and (3) Facility where the procedure is performed: (a) Has protocols available for review by the Board; (b) Documents the training provided to the radiographer; and (c) Evaluates the radiographer on a regular basis for competency, documents the results of these tests, and makes the results available for inspection by the Board. C. The scope of practice of radiography includes the insertion and removal of peripherally inserted central catheters with or without fluoroscopic guidance if the: (1) Radiographer is: (a) Registered by the ARRT in advanced qualifications in cardiac-interventional radiography, vascular-interventional radiography, or cardiovascular-interventional radiography; (b) Working in a cardiac catheterization laboratory or interventional radiographic laboratory while cardiac catheterization or interventional procedures are ongoing; and (c) Under the onsite supervision of the supervising physician; (2) Supervising physician in the cardiac catheterization or interventional laboratory is responsible for the acts of the radiographer with respect to insertion or removal of peripherally inserted central catheters; and (3) Facility where the procedure is performed: (a) Has protocols available for review by the Board; (b) Documents the training provided to the radiographer; and (c) Evaluates the radiographer on a regular basis for competency, documents the results of these tests, and makes the results available for inspection by the Board. #### Regulation .10 Scope of Practice — Nuclear Medicine Technology. *COMAR 10.32.10.10* A. The scope of practice of nuclear medicine technology includes the following: (1) Scope of practice for diagnostic in-vivo procedures and in-vitro procedures which includes: (a) Analysis and correlation of procedure request and clinical information provided by the referring physician or patient, or both, for determination of appropriate exam, extent, and scope; (b) Evaluation of the physical and emotional status of the patient with respect to the ability to undergo the procedure requested; (c) Immediate predose review of patient's identification, prescribed dose quantity and route of administration, and identification of the test agent designed to prevent dose misadministration; (d) Preparation of the appropriate radiopharmaceutical with measurement of dose activity; (e) Administration of appropriate diagnostic dose levels of radiopharmaceuticals; (f) Administration of nonradioactive pharmaceuticals utilized in conjunction with a nuclear medicine imaging or in-vivo procedure, for example, cholecystokinin, furosemide, vitamin B12, in accordance with hospital or facility procedures, excluding narcotic and sedating medication; (g) Selection of appropriate imaging or test parameters, or both; (h) Obtaining images according to established protocols and any special views to optimize information as appropriate; (i) Placement of patient in proper position using supportive materials and immobilizer as necessary; (j) Assuring appropriate image labeling as to patient identification, position, and appropriate anatomic land marks for each view; (k) Evaluation of images or data, or both, for technical quality; (l) Recognition of unusual variances in the images or data, or both, caused by instrumentation malfunction and initiating appropriate action; (m) Monitoring of patient and equipment during procedure for determination and application of any corrective actions necessary; (n) Monitoring of data collection and processing and performance of technical analysis of test results; (o) Preparation and performance of laboratory in-vivo nuclear medicine procedures, inclusive of the selection and operation of laboratory counting equipment, performance of calculations and data processing necessary for completion of lab procedures and the submission of results to the physician or licensee; (p) Oversight and application of image development; and (q) Performance of in-vitro testing of serum, plasma, or other body fluids using radio immunoassay, or similar ligand assay methods; (2) Scope of practice for handling radiopharmaceuticals which includes: (a) Preparation, by means of tagging, compounding, etc., in accordance with manufacturer's specifications; (b) Measurement and calculation of activity of radionuclides with a dose calibrator; (c) Application of radioactive decay calculations to determine required volume or unit form necessary to deliver the prescribed radioactive dose; and (d) Recording of radiopharmaceutical information on a patient's permanent record; (3) Scope of practice for radionuclide therapy which includes: (a) Assisting licensed physician in the preparation and applications of therapeutic radionuclides; (b) Oversight of radiation safety practices related to the handling and administration of radiopharmaceuticals for therapy of patients; (c) Management of transportation and handling of therapeutic radiopharmaceuticals; (d) Calibration of therapeutic radiopharmaceuticals for dose accuracy; and (e) Radiation monitoring, decontamination, disposal, and patient follow-up as appropriate and required; (4) Scope of practice for radiation safety which includes: (a) Maintenance of records of radioactive material receipt, use, storage, and disposal in accordance with regulatory requirements; (b) Oversight and enforcement of radiation safety policies, practices, and regulations regarding the possession and use of radioactive materials; and (c) Performance of radiation safety procedures such as radiation survey and wipe testing of incoming radioactive shipments and facility fixtures; (5) Operation of a hybrid nuclear medicine/CT device for a nondiagnostic attenuation correction CT without intravenous contrast; and (6) Performing any other duties that the Board determines may be performed by a nuclear medicine technologist. B. The scope of practice of a nuclear medicine technologist includes operation of a standalone CT or hybrid nuclear medicine/CT device for a diagnostic CT with or without intravenous contrast if the nuclear medicine technologist: (1) Has successfully passed the ARRT or NMTCB specialty exam for CT; and (2) Administers contrast media after consultation with, and under the supervision of, a physician who is immediately and physically available. C. In order to meet the eligibility requirements to sit for the ARRT or the NMTCB post-primary CT examination, a licensed nuclear medicine technologist may perform all procedures involving diagnostic CT with or without intravenous contrast only under the direct supervision of a: (1) Licensed nuclear medicine technologist with the post-primary CT credential; (2) Licensed radiographer with the post-primary CT credential; or (3) Licensed radiologist or radiation oncologist. #### Regulation .11 Scope of Practice — Radiologist Assistant. *COMAR 10.32.10.11* A. The scope of practice of a radiologist assistant includes the following activities to obtain the clinical history and physical examination of the patient: (1) Review the patient's medical record to verify the appropriateness of a specific exam or procedure; (2) Interview the patient to obtain, verify, or update medical history; (3) Explain procedure to the patient or significant others, including a description of risks, benefits, alternatives, and follow-up; (4) Obtain informed consent; (5) Determine if the patient has followed instructions in preparation for the exam such as diet and premedications; (6) Assess risk factors that may be contraindications to the procedure such as health history, medications, pregnancy, psychological indicators, and alternative medicines; (7) Obtain and evaluate vital signs; (8) Perform physical examination and analysis of data such as signs and symptoms, laboratory values, and significant abnormalities, as required by the imaging procedure to be conducted; and (9) Report findings related to Regulation .10A(1)—(5) of this chapter to the supervising radiologist or radiation oncologist. B. The scope of practice of a radiologist assistant includes the following general procedures: (1) Apply ECG leads and recognize life threatening ECG abnormalities; (2) Perform urinary catheterization; (3) Perform venipuncture; (4) Monitor IV for flow rate and complications; (5) Position patient to perform required procedure, using immobilization devices and modifying technique as necessary; (6) Assess patient's vital signs and levels of anxiety and pain and inform the radiologist or radiation oncologist when appropriate; (7) Recognize and respond to medical emergencies, such as drug reactions, cardiac arrest, and hypoglycemia, and activate emergency response systems, including notification of the radiologist; (8) Administer oxygen as prescribed; (9) Operate a fixed/mobile fluoroscopic unit; (10) Assure documentation of fluoroscopy time; (11) Explain effects and potential side effects to the patient of the pharmaceutical required for the examination; (12) Administer contrast agents as prescribed by the radiologist or radiation oncologist; (13) Administer general medications, excluding radiopharmaceuticals and narcotic or sedating medications, as prescribed by the radiologist; and (14) Monitor patient for side effects or complications of the pharmaceuticals. C. The scope of practice of the radiologist assistant includes performing the following examinations and procedures, including contrast media administration, placement of needle or catheter, and operation of imaging equipment, under the immediate available direction of a radiologist or radiation oncologist: (1) Upper GI; (2) Esophagus; (3) Small bowel studies; (4) Barium enema; (5) Evaluation of percutaneous gastric and enteric tubes; (6) Swallowing study; (7) Cystogram and voiding cystourethrogram; and (8) Nasoenteric and oroenteric feeding tube placement. D. The scope of practice of the radiologist assistant includes performing the following examinations and procedures, including contrast media administration, placement of needle or catheter, and operation of imaging equipment, under the on-site supervision of a radiologist or radiation oncologist: (1) Joint injection and aspiration; (2) Arthrogram, including conventional, CT, and MR; (3) PICC placement; (4) Paracentesis with appropriate image guidance; (5) Thoracentesis with appropriate image guidance; (6) Lumbar puncture under fluoroscopic guidance; (7) Fistulogram; and (8) Port injection. E. On a case-by-case basis as specified in Regulation .12 of this chapter, the Board or its designee may approve a radiologist assistant to perform one or more of the following procedures under the level of supervision by a radiologist or radiation oncologist as specified in the request letter submitted by the radiologist or radiation oncologist and radiologist assistant: (1) Lower extremity venography; (2) Lumbar, thoracic, or cervical myelography; (3) Non-tunneled venous central line placement; (4) Venous catheter placement for dialysis; (5) Breast needle localization; (6) Ductogram (galactogram); (7) T-tube cholangiogram; (8) Retrograde urethrogram; (9) Sinogram; (10) Loopogram; (11) Hysterosalpingogram; and (12) Other specific procedures approved by the Board. F. The scope of practice of a radiologist assistant includes the following post-imaging activities: (1) Review of imaging procedures, making initial observations, and communicating observations only to the radiologist or radiation oncologist; (2) Communication of radiologist's report to referring physician; (3) Provision of radiologist-prescribed post-care instructions to patients; (4) Performance of follow-up patient evaluation, and communication of findings to the radiologist or radiation oncologist; (5) Documenting procedure in appropriate record, and documenting exceptions from established protocol or procedure; (6) Writing patient discharge summary for review and co-signature by the radiologist or the radiation oncologist; (7) Participating in quality improvement activities within radiology practice; and (8) Assisting with data collection and review for clinical trials or other research. #### Regulation .12 Request for Radiologist Assistant to Perform Advanced Procedures. *COMAR 10.32.10.12* A. Eligibility. The Board may grant a radiologist assistant permission to perform one or more of the procedures specified in Regulation .11E of this chapter based on the following criteria: (1) Evidence of satisfactory completion of an adequate number of cases for the procedure being requested; and (2) Level of supervision of the radiologist assistant, as specified by the radiologist. B. Request. The radiologist or radiation oncologist and radiologist assistant shall jointly request approval to perform a special procedure by submitting a letter that includes the following information: (1) Special procedures requested; and (2) Documentation of satisfactory completion of an adequate number of cases of the procedure. C. Training and Experience. Documentation of successful completion of cases of a procedure may include: (1) Cases submitted to ARRT for registration as a registered radiologist assistant; and (2) Other cases performed under the supervision of a radiologist or radiation oncologist who is present and observing the procedure. D. Board Approval. (1) Except as provided in §D(2) of this regulation, a licensed radiologist assistant may not perform any of the procedures specified in Regulation .11E of this chapter until the Board or its designee has approved the special procedure request submitted by the radiologist or radiation oncologist and radiologist assistant. (2) A licensed radiologist assistant may perform a procedure for training purposes under the direct supervision of a radiologist who is: (a) Physically present with the patient and the radiologist assistant; and (b) Observing the performance of the procedure by the radiologist assistant. #### Regulation .13 Renewal and Reinstatement. *COMAR 10.32.10.13* A. Renewal. (1) The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. (2) An individual who has been licensed by the Board as a radiation therapist, radiographer, or nuclear medicine technologist shall renew the license every 2 years on the date specified by the Board by: (a) Completing a renewal application on a form approved by the Board; (b) Paying a renewal fee as specified in Regulation .18 of this chapter; and (c) Attesting to one of the following: (i) Completion of at least 24 hours of approved continuing education earned during the 2-year period preceding the expiration of the license for radiation therapist, radiographer, or nuclear medicine technologist, in accordance with the requirements specified in §A(5) of this regulation; (ii) Current American Registry of Radiologic Technologists (ARRT) registration; or (iii) Active certification by the Nuclear Medicine Technology Certification Board. (3) An individual who has been licensed by the Board as a radiologist assistant shall renew the license every 2 years on the date specified by the Board by: (a) Completing a renewal application on a form approved by the Board; (b) Paying a renewal fee as specified in Regulation .18 of this chapter; (c) Attesting to one of the following: (i) Completion of at least 50 hours of approved continuing education earned during the 2-year period preceding the expiration of the license for radiologist assistant, in accordance with the requirements specified in §A(5) of this regulation; or (ii) Current American Registry of Radiologic Technologists (ARRT) registration as a radiologist assistant. (4) Continuing education hours that are used to satisfy the continuing education requirement for renewal of a license as a radiographer may also be used to satisfy the continuing education requirement for a radiologist assistant. (5) Approved continuing education is as follows: (a) In-service programs at a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a health maintenance organization certified by the State; or (b) Programs relevant to the practice of a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant approved by the: (i) American College of Radiology or its chapters; (ii) Maryland Society of Radiologic Technologists; (iii) Mideastern Chapter—Society of Nuclear Medicine — Technologist Section; (iv) Mideastern Chapter—Society of Nuclear Medicine or the District of Columbia Chapter of the American College of Radiology; (v) American Medical Association; (vi) MedChi, the Maryland State Medical Society; or (vii) American Society of Radiologic Technologists. (6) The continuing education requirement applies to all renewal applications after the first renewal. B. Reinstatement. The Board shall reinstate the license of a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant if the individual: (1) Completes a reinstatement application on a form approved by the Board; (2) Pays a reinstatement fee as defined in Regulation .18 of this chapter; and (3) Documents evidence of: (a) For a radiographer, radiation therapist, or nuclear medicine technologist, at least one of the following requirements: (i) Completion of at least 24 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement of the license for radiation therapist, radiographer, or nuclear medicine technologist; (ii) Current ARRT registration; or (iii) Active certification by the NMTCB; or (b) For a radiologist assistant, at least one of the following requirements: (i) Completion of at least 50 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement of the license for radiologist assistant; or (ii) Current ARRT registration as a radiologist assistant. #### Regulation .14 Prohibited Conduct. *COMAR 10.32.10.14* A. Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, the Board may deny an application, may reprimand any licensed radiation therapist, licensed radiographer, licensed nuclear medicine technologist, licensed radiologist assistant, place any licensed radiation therapist, licensed radiographer, licensed nuclear medicine technologist, licensed radiologist assistant, on probation, or suspend or revoke the license of any licensed radiation therapist, licensed radiographer, licensed nuclear medicine technologist, or licensed radiologist assistant for the commission of a prohibited act. B. The following are prohibited acts: (1) Fraudulently or deceptively obtaining or attempting to obtain a license for the applicant or licensed individual or for another; (2) Fraudulently or deceptively using a license; (3) Being guilty of unprofessional or immoral conduct in the practice of radiation therapy, radiography, nuclear medicine technology, or radiology assistance; (4) Being professionally, physically, or mentally incompetent; (5) Abandoning a patient; (6) Habitually being intoxicated; (7) Being addicted to or abusing any narcotic or controlled dangerous substance as defined in Criminal Law Article, Annotated Code of Maryland; (8) Providing professional services while: (a) Under the influence of alcohol; (b) Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; (9) Promoting the sale of services, drugs, devices, appliances, or goods to a patient to exploit the patient for financial gain; (10) Willfully making or filing a false report or record in the practice of radiation therapy, radiography, nuclear medicine technology, or radiology assistance; (11) Willfully failing to file or record any report as required under law, willfully impeding or obstructing the filing or recording of the report, or inducing another to fail to file or record the report; (12) Paying or agreeing to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepting or agreeing to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient; (13) Knowingly making a misrepresentation while practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance; (14) Knowingly practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance with an unauthorized person or aiding an unauthorized person in the practice of radiation therapy, radiography, nuclear medicine technology, or radiology assistance; (15) Offering, undertaking, or agreeing to cure or treat disease by a secret method, treatment, or medicine; (16) Being disciplined by a licensing or disciplinary authority, being convicted or disciplined by a court of any state or country or disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under the Board's disciplinary statutes or this regulation; (17) Failing to meet appropriate standards as determined by appropriate peer review for the delivery of quality radiation therapy care, radiography care, nuclear medicine technology care, or radiology assistance care performed in an outpatient surgical facility, office, hospital, or any other location in this State; (18) Knowingly submitting false statements to collect fees for which services are not provided; (19) Having been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under this regulation and the licensed individual: (a) Surrendered the license issued by the state or country, or (b) Allowed the license issued by the state or country to expire or lapse; (20) Knowingly failing to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (21) Selling, prescribing, giving away, or administering drugs for illegal or illegitimate purposes; (22) Breaching patient confidentiality; (23) Practicing beyond the authorized scope of practice; (24) Practicing or attempting to practice any radiation therapy, radiography, nuclear medicine technology, or radiology assistance procedure, or using radiation therapy, radiography, nuclear medicine technology, or radiology assistance equipment, if the applicant or licensed individual has not received education, training, or experience in the use of that procedure or the use of the equipment; (25) Refusing, withholding from, denying, or discriminating against an individual with regard to the provision of professional services for which the license holder is licensed and qualified to render because the individual is HIV positive; (26) Failing to cooperate with a lawful investigation of the Board; (27) Failing to practice under the supervision of a physician or violating a supervisory order of a supervising physician; or (28) Failing to comply with these regulations. C. Unprofessional conduct in the practice of medicine, under Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland, includes the failure of a physician to comply with the statute and regulations governing the physician's duty to supervise a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant. D. Crimes of Moral Turpitude. (1) On the filing of certified docket entries with the Board by the Attorney General, the Board shall order the suspension of a license if the licensee has been convicted of, or pled guilty or nolo contendere with respect to, a crime involving moral turpitude, regardless of whether any appeal or other proceeding is pending to have the conviction or plea set aside. (2) After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime of moral turpitude, the Board shall order the revocation of the license. #### Regulation .15 Investigations, Hearings, and Appeals. *COMAR 10.32.10.15* A. Complaints alleging prohibited conduct shall be referred to the Board to be investigated according to the Board's procedures. B. A hearing on charges issued under Regulation .14A of this chapter or Health Occupations Article, §14-5B-14(a), Annotated Code of Maryland, shall be held in accordance with the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland. C. Proceedings for crimes of moral turpitude, under Health Occupations Article, §14-5B-14(c), Annotated Code of Maryland, or Regulation .14D of this chapter shall be held in accordance with COMAR 10.32.02.04. D. All other hearings shall be held in accordance with the Administrative Procedure Act. E. Appeals from a final Board decision shall be taken in accordance with Health Occupations Article, §14-5B-14.1, Annotated Code of Maryland. #### Regulation .16 Penalties, Fines, and Sanctioning Guidelines. *COMAR 10.32.10.16* A. The Board may impose a civil fine of not more than $5,000 on an individual who is not licensed to practice radiation therapy, radiography, nuclear medical technology, or radiology assistance in Maryland if the individual: (1) Represents to the public in any way that the individual is authorized to practice radiation therapy, radiography, nuclear medicine technology, or radiology assistance; (2) Practices or attempts to practice radiation therapy, radiography, nuclear medicine technology, or radiology assistance; or (3) Violates any provision of Health Occupations Article, Title 14, Subtitle 5B, Annotated Code of Maryland, or any regulation in this chapter. B. The Board shall deposit a penalty collected under §A of this regulation into the Board of Physicians fund. C. The Board may impose a civil fine of not more than $1,000 on an individual who fails to file a report under Regulation .17 of this chapter. D. The Board may impose a civil fine of not more than $1,000 on a licensed physician or employer who employs or supervises an individual practicing radiation therapy, radiography, nuclear medicine technology, or radiology assistance without a license. E. The Board shall deposit a fine collected under §D or E of this regulation into the General Fund. F. General Application of Sanctioning Guidelines. (1) Sections F and G of this regulation and Regulation .19 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §G of this regulation, for violations of the sections of the Maryland Radiation Therapy, Radiography, Nuclear Medicine Technology, and Radiology Assistance Act listed in the sanctioning guidelines, the Board shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation. (c) A stayed suspension not meeting the criteria for §F(3)(b) of this regulation is ranked as a reprimand. (d) A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction. If a minimum fine is listed, at least the minimum fine shall be imposed in addition to the sanction listed. (e) The addition of a fine does not change the ranking of the severity of the sanction. (4) The Board may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and (b) The Board may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .19 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by the Board, the administrative prosecutor, and the licensee. (8) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (9) If the Board imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .19 of this chapter, the Board shall state its reasons for doing so in its final decision and order. G. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. (3) The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (4) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (5) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. (6) A departure from the sanctioning guidelines set forth in Regulation .19 of this chapter is not a ground for any hearing or appeal of a Board action. H. The Board may impose a fine of $100 for a violation of Health Occupations Article, §14-5B-12.1, Annotated Code of Maryland. I. Offenses Related to Continuing Medical Education Credits. (1) First Offense of Failure to Document Credits. (a) Except as provided in §I(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §14-5B-12, Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-5B-14, Annotated Code of Maryland. (b) Section I(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits. (2) Willful Falsification. (a) If a licensee has willfully falsified an application with respect to continuing medical education credits, the licensee may be charged under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5B-14(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5B-14(a)(10), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-5B-14(a)(11), Annotated Code of Maryland. (b) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5A-14, Annotated Code of Maryland, and the sanctioning guidelines. (3) Licensees Previously Disciplined Under §I(1) or (2) of this Regulation. (a) If a licensee has been previously fined or otherwise disciplined under §I(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing medical education credits, charge a licensee under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5B-14(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5B-14(a)(10), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-5B-14(a)(11), Annotated Code of Maryland. (b) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5B-14, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense. (c) The Board may not apply the sanction described in §I(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing medical education credits. (4) The Board shall pay all monies collected pursuant to §I of this regulation into the Board of Physicians Fund. J. Payment of Fines. (1) An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise. (2) Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation. (3) If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full. (4) In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. #### Regulation .17 Required Reports. *COMAR 10.32.10.17* A. Except as provided in §B of this regulation, an employer of a licensed radiation therapist, licensed radiographer, a licensed nuclear medical technologist, or licensed radiologist assistant shall report to the Board if the employer limits, reduces, or otherwise changes the responsibilities of or terminates a licensed therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant for any reason that might be grounds for disciplinary action under Health Occupations Article, Title 14, Subtitle 5B, Annotated Code of Maryland, or any regulation in this chapter. B. If the action taken by an employer under §A relates to alcohol or drug impairment, reporting shall be in compliance with Health Occupations Article, §14-5B-15(b),(c), and (d), Annotated Code of Maryland. C. A licensed radiation therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant shall notify the licensee's employer of a decision to enter an accredited alcohol or drug treatment program. D. An accredited alcohol or drug treatment program that is treating a licensed radiation therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant who has given notice to his employer under §C of this regulation shall notify the employer if the licensed radiation therapist, licensed radiographer, licensed nuclear medical technologist, or licensed radiologist assistant is found to be noncompliant with the treatment program's policies and procedures. E. An individual is not required to make a report under this regulation that would be in violation of any federal or State law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records. #### Regulation .18 Fees. *COMAR 10.32.10.18* The following fees are applicable to radiation therapists, radiographers, nuclear medicine technologists, and radiologist assistants: A. Application for initial licensure fee — $150; B. Renewal Fees: (1) Renewal of license fee — $135; and (2) Maryland Health Care Commission (MHCC) fee — As determined by MHCC under COMAR 10.25.03; C. Reinstatement of license fee — $150; D. Written verification fee — $25; and E. Other Fees: (1) Duplicate license — $25; (2) Duplicate wall certificate — $25. #### Regulation .19 Sanctioning Guidelines for Radiation Therapists, Radiographers, Nuclear Radiation Technologists, and Radiologist Assistants. *COMAR 10.32.10.19* A. Subject to provisions of Regulation .16F and G of this chapter, the Board may impose sanctions as outlined in §B of this regulation on a radiation therapist, radiographer, nuclear medicine technologist, or radiologist assistant for violations of Health Occupations Article, §14-5B-14(a), Annotated Code of Maryland. B. Range of Sanctions. ### Chapter 11 — Licensing of Respiratory Care Practitioners **Authority:** Health Occupations Article, §§1-213, 1-606, 14-205(a), 14-5A, and 14-5C-03, Annotated Code of Maryland;Ch. 328, Acts of 2008 **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .06, .08, and .09 adopted effective November 11, 1991 (18:22 Md. R. 2396) **Administrative History:** Regulation .02B amended effective April 25, 1994 (21:8 Md. R. 674) **Administrative History:** Regulation .03 amended effective August 1, 1994 (21:15 Md. R. 1306) **Administrative History:** Regulation .05-1 adopted effective April 25, 1994 (21:8 Md. R. 674) **Administrative History:** Regulation .07 adopted effective February 17, 1992 (19:3 Md. R. 305) **Administrative History:** Chapter, Certification of Respiratory Care Practitioners, repealed and new chapter, Licensing of Respiratory Care Practitioners, adopted effective August 25, 1997 (24:17 Md. R. 1215) **Administrative History:** Regulation .04 amended effective February 14, 2005 (32:3 Md. R. 290) **Administrative History:** Regulation .07 repealed as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); repealed permanently effective November 3, 2008 (35:22 Md. R. 1957) **Administrative History:** Regulation .08 repealed as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); repealed permanently effective November 3, 2008 (35:22 Md. R. 1957) **Administrative History:** Regulation .11 amended as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); amended permanently effective November 3, 2008 (35:22 Md. R. 1957) **Administrative History:** Regulation .12 repealed and new Regulation .12 adopted effective February 14, 2005 (32:3 Md. R. 290) **Administrative History:** Regulation .12 amended as an emergency provision effective October 1, 2008 (35:21 Md. R. 1822); amended permanently effective November 3, 2008 (35:22 Md. R. 1957) **Administrative History:** Regulation .13 adopted effective August 19, 2002 (29:16 Md. R. 1288) **Administrative History:** Regulation .14 adopted effective August 19, 2002 (29:16 Md. R. 1288) **Administrative History:** Regulation .15 adopted effective August 19, 2002 (29:16 Md. R. 1288) **Administrative History:** Chapter revised effective March 7, 2011 (38:5 Md. R. 317) **Administrative History:** Regulation .01E adopted effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .02B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .04B, C amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .04D, E adopted effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .04F amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .06 amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .07 amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .08 adopted effective May 11, 2015 (42:9 Md. R. 647) **Administrative History:** Regulation .09 amended effective January 2, 2017 (43:26 Md. R. 1446) **Administrative History:** Regulation .10A amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .11 amended effective January 2, 2017 (43:26 Md. R. 1446); January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .13A amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .14B amended effective January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .15 amended effective July 22, 2013 (40:14 Md. R. 1176); January 19, 2026 (53:1 Md. R. 21) **Administrative History:** Regulation .16 adopted effective July 22, 2013 (40:14 Md. R. 1176) #### Regulation .01 Scope. *COMAR 10.32.11.01* A. This chapter governs the practice of respiratory care. B. This chapter does not prohibit any respiratory care student who is currently enrolled in an approved respiratory care educational program from performing any of the procedures described in this chapter as part of that program's respiratory care clinical curriculum. C. This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under the Health Occupations Article, Annotated Code of Maryland. D. This chapter does not apply to an individual employed by the federal government as a respiratory care practitioner while the individual is practicing within the scope of that employment. E. This chapter does not apply to an individual practicing respiratory care who is licensed by and resides in another jurisdiction if: (1) The individual is participating in the transportation of a patient from that individual’s jurisdiction of licensure into the State; (2) The individual practices respiratory care only during the transportation of the patient; (3) The individual does not practice respiratory care on another individual who is not the patient being transported into the State; and (4) The individual does not practice respiratory care in the State for more than 14 days within a calendar year. #### Regulation .02 Definitions. *COMAR 10.32.11.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “AARC” means the American Association for Respiratory Care. (2) “Accredited respiratory care education program” means a program accredited by the Commission on Accreditation for Respiratory Care or its successor. (3) “Applicant” means an individual who applies to the Board for licensure as a respiratory care practitioner. (4) “Board” means the State Board of Physicians. (5) “Clinical supervision” means the responsibility of a respiratory care practitioner to exercise on-site or immediately available direction for respiratory care departments, the provision of any respiratory care services, licensed respiratory care practitioners, or students practicing respiratory care. (6) “Collaboration” means a respiratory care practitioner practicing in association with and under the direction of a physician to plan and implement a regimen of care. (7) “Committee" means the Respiratory Care Professional Standards Committee of the Board. (8) “Disciplinary panel” means a panel established under Health Occupations Article, §14-401, Annotated Code of Maryland, which: (a) Is composed of 11 Board members; and (b) Addresses: (i) Complaints and disciplinary actions against licensed physicians and allied health professionals; (ii) Initial licensure decisions; and (iii) Postdisciplinary licensure reinstatements. (9) “Licensee” means a licensed respiratory care practitioner. (10) “Mechanical ventilation” means utilizing positive or negative pressure to provide inspiratory support by invasive or noninvasive means. (11) “National Certifying Board” means the National Board for Respiratory Care, Inc. or its successor. (12) “Physician” means an individual licensed to practice medicine in Maryland. (13) “Practice of respiratory care” means the diagnostic evaluation, care and treatment, management, and rehabilitation of patients who have deficiencies and abnormalities which affect the pulmonary system and associated aspects of the cardiopulmonary and other systems. (14) “Respiratory care practitioner” means an individual licensed by the Board to practice respiratory care. (15) “Supervision” means the responsibility of a physician to exercise on-site or immediately available direction for a licensed respiratory care practitioner performing delegated medical acts. #### Regulation .03 Incorporation by Reference. *COMAR 10.32.11.03* The American Association for Respiratory Care Clinical Practice Guidelines (1997) is incorporated by reference. #### Regulation .04 Committee. *COMAR 10.32.11.04* A. The Board shall establish a Respiratory Care Professional Standards Committee composed of the following individuals: (1) Three licensed respiratory care practitioners; (2) One licensed physician whose specialty is thoracic surgery; (3) One licensed physician whose specialty is pulmonary medicine; (4) One licensed physician whose specialty is anesthesiology; and (5) One consumer member who meets the requirements specified in Health Occupations Article, §14-5A-06(b), Annotated Code of Maryland. B. Chair. (1) The Committee shall elect a chair from among its members. (2) The chair shall serve for a term of 2 years. C. Tenure. (1) The term of a member is 3 years. (2) A member continues to serve until a successor is appointed. (3) A member appointed after a term has begun serves only for the rest of the term and until a successor has been appointed. (4) A member may not serve more than 2 consecutive terms. D. Vacancy. If a vacancy occurs on the Committee, the Board shall appoint a new member to serve, as provided in §C of this regulation. E. Quorum. (1) A majority of the members then serving on the Committee constitutes a quorum. (2) Business may not be conducted at a Committee meeting unless there is a quorum. F. The Committee may develop and make recommendations to the Board in any matters related to regulating the practice of respiratory care. #### Regulation .05 Code of Ethics. *COMAR 10.32.11.05* A. A respiratory care practitioner shall: (1) Practice medically acceptable methods of treatment and may not endeavor to practice beyond the competence and the authority vested in the respiratory care practitioner by the physician; (2) Continually strive to increase and improve the knowledge and skill to render to each patient the full measure of the respiratory care practitioner's ability; (3) Be responsible for the competent and efficient performance of assigned duties; (4) Expose incompetence and illegal or unethical conduct of members of the profession; (5) Hold in strict confidence all privileged information concerning the patient; (6) Refer all inquiries to the physician in charge of the patient's medical care; (7) Accept no gratuities for preferential consideration of the patient; (8) Guard against conflicts of interest; (9) Uphold the dignity and honor of the profession and abide by its ethical principles; (10) Be familiar with existing State and federal laws governing the practice of respiratory care and comply with those laws; and (11) Cooperate with other health care professionals and participate in activities to promote community and national efforts to meet the health needs of the public. B. A breach of the ethical principles stated in §A of this regulation may be considered immoral or unprofessional conduct in the practice of respiratory care. C. All services shall be provided with respect for the dignity of the patient, unrestricted by considerations of social or economic status, personal attributes, or the nature of health problems. #### Regulation .06 Qualifications for Licensure as a Respiratory Care Practitioner. *COMAR 10.32.11.06* A. The Board shall license an individual if the individual meets the requirements of §§B and C of this regulation. B. An individual shall be licensed by the Board if the individual: (1) Is 18 years old or older; (2) Is of good moral character; (3) Demonstrates spoken and written competency in English by any of the following: (a) Graduation from a recognized English-speaking high school or undergraduate or graduate school after at least 3 years of enrollment; (b) Graduation from a recognized English-speaking professional school; or (c) Receipt of a grade of: (i) At least 79 on the Internet-based Test of English as a Foreign Language; and (ii) At least 26 on the “Speaking” section of the Internet-based Test of English as a Foreign Language; (4) Graduate from an accredited respiratory care educational program; and (5) Have active certification by the National Certifying Board as at least one of the following: (a) Certified respiratory therapist; or (b) Registered respiratory therapist. C. An individual shall submit a completed application form, which includes the following information: (1) A chronological history of practice-related activities as requested by the Board for: (a) All periods of time, including each job held; and (b) Any other activity engaged in, including all periods of unemployment; (2) Any physical or mental condition that currently impairs the individual’s ability to practice respiratory care; (3) Any action by a state licensing or disciplinary board or a comparable body in the armed services, denying an application for licensure, reinstatement, or renewal for a health care occupational license; (4) Any health professional license for which the individual has applied if the application was withdrawn for reasons that would be grounds for disciplinary action; (5) Any action taken against the individual’s license by a state licensing or disciplinary board, or a comparable body in the armed services, including but not limited to: (a) Limitations of practice; (b) Required education; (c) Admonishment; (d) Reprimand; (e) Suspension; or (f) Revocation; (6) Any investigation or charges brought against the individual by a state licensing or disciplinary board or comparable body in the armed services; (7) Copies of: (a) State licensing or disciplinary board charges; (b) Final orders; or (c) Adverse or disciplinary actions; (8) Any investigation or charge brought against the individual by: (a) A hospital; (b) A related institution; (c) An alternative health care system; or (d) Any other employer; (9) Any limitation or loss in privileges by: (a) A hospital; (b) A related health care facility; (c) An alternative health care system; or (d) Any other employer; (10) Copies of the complaints, pleadings, and judgments in all malpractice claims; (11) Copies of all arrests, court orders, orders of probation, certificates or letters of completion, or both, of any mandatory program or disciplinary actions, including final orders for driving while intoxicated or driving while under the influence of a chemical substance or medication; (12) A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for a criminal act; and (13) A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for an alcohol or controlled dangerous substance offense, including but not limited to driving while under the influence of alcohol or controlled dangerous substances. D. An applicant shall pay the required application fee. E. An applicant shall submit a passport-size photograph. F. On forms supplied by the Board, an applicant shall agree to release to the Board all relevant information from appropriate individuals, other institutions, and government agencies including, but not limited to: (1) The National Practitioner Data Bank; (2) Hospitals; and (3) Any other licensing body. G. An applicant for licensure shall inform the Board by certified mail, return receipt requested, within 30 days of the occurrence or notification of any of the circumstances listed in §B of this regulation. H. If reasonable questions regarding an applicant's physical, mental, or professional competency have been raised by the information provided on the application, the Board may request additional information regarding the applicant's competency from the chief of staff of a hospital where the applicant has practiced. I. If an applicant has not passed the National Certifying Board exam for credentialing as a Certified Respiratory Therapist or a Registered Respiratory Therapist within the 5 years immediately preceding the applicant’s application and has not practiced respiratory care for at least 3 of the past 5 years, the Board may require the applicant to take and pass one of those exams as part of the application process. #### Regulation .07 Examination. *COMAR 10.32.11.07* A. A disciplinary panel may require an applicant for licensure or a licensee to submit to one or more physical, mental, or other examinations, by a physician or evaluation program for treatment of impaired respiratory care practitioners, or both, chosen by a disciplinary panel to determine the applicant's ability to practice respiratory care. B. The applicant or licensee shall pay the costs of the evaluations required in §A of this regulation. #### Regulation .08 Qualifications for Respiratory Care Practitioners Practicing Polysomnography. *COMAR 10.32.11.08* A. A respiratory care practitioner licensed by the Board to practice respiratory care on or before December 31, 2012, whose duties include practicing respiratory care in a sleep laboratory or practicing polysomnography, is not required to obtain an additional license to practice polysomnography. B. A respiratory care practitioner licensed after December 31, 2012, whose duties include practicing polysomnography shall obtain a separate license to practice polysomnography. #### Regulation .09 Scope of Practice, Identification, and Change in Name or Address. *COMAR 10.32.11.09* A. A respiratory care practitioner may practice only under the supervision of and in collaboration with a physician. B. The practice of respiratory care includes the following: (1) Direct and indirect respiratory care services that are safe, aseptic, preventive, and restorative to the patient; (2) The practice of the principles, techniques, and theories derived from cardiopulmonary medicine; (3) Evaluation and treatment of individuals whose cardiopulmonary functions have been threatened or impaired by developmental defects, the aging process, physical injury, disease, or actual or anticipated dysfunction of the cardiopulmonary system; (4) Observation and monitoring of physical signs and symptoms, general behavior, and general physical response to respiratory care procedures, and determination of whether initiation, modification, or discontinuation of the treatment regimen is warranted; (5) The transcription and implementation of a written or oral order, or both, pertaining to the practice of respiratory care; (6) Evaluation techniques including cardiopulmonary functional assessments, gas exchange, the need and effectiveness of therapeutic modalities and procedures, and assessment and evaluation of the need for extended care and home care procedures, therapy, and equipment; (7) Professional application of techniques, equipment, and procedures involved in the administration of respiratory care such as: (a) Therapeutic and diagnostic gases (excluding general anesthesia); (b) Prescribed medications for inhalation or direct tracheal instillation; (c) The administration of prescribed analgesic agents including substances listed in Schedule IV as defined in Criminal Law Article, §5-405, Annotated Code of Maryland, by subcutaneous injection or inhalation for the performance of respiratory care procedures; (d) Nonsurgical intubation, maintenance, and extubation of artificial airways; (e) Advanced cardiopulmonary measures; (f) Chest needle decompression; (g) Cardiopulmonary rehabilitation; (h) Mechanical ventilation or physiological life support systems; (i) Collection of body fluids and blood samples for evaluation and analysis, including collection by intraosseous access; (j) Insertion of diagnostic arterial access lines, including large bore intravenous access; and (k) Collection and analysis of exhaled respiratory gases; (8) The clinical supervision of licensed respiratory care practitioners, respiratory care departments, or the provision of any respiratory care services; and (9) The respiratory care clinical instruction or oversight of respiratory care students, while performing respiratory care procedures as part of their clinical curriculum. C. A respiratory care practitioner shall wear an identification tag or a badge which identifies that individual as a respiratory care practitioner. D. Change in Name or Address. (1) Within 60 days after the change, a licensee shall notify the Board in writing of a change in name or address. (2) Licensees who fail to notify the Board of name or address changes as required by §D(1) of this regulation are subject to an administrative penalty of $100. #### Regulation .10 Standard of Care. *COMAR 10.32.11.10* A. In evaluating the standard of care for the practice of a licensed respiratory care practitioner, the Board shall utilize the AARC’s National Clinical Practice Guidelines. B. If a particular practice issue has not yet been addressed in the AARC guidelines, the Board may consult with the Maryland/District of Columbia Society for Respiratory Care or any licensed respiratory care practitioner to determine whether a respiratory care practitioner being investigated by the Board is practicing within the acceptable standard of care. #### Regulation .11 Renewal, Reinstatement, and Continuing Education. *COMAR 10.32.11.11* A. Renewal. (1) The term of a license issued by the Board may not exceed 3 years. (2) The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. (3) An individual who has been licensed by the Board as a respiratory care practitioner may renew the license for an additional term on the date specified by the Board by: (a) Completing an online renewal application on a form supplied by the Board; (b) Paying the required renewal fee set by the Board; (c) Attesting to the completion of at least 16 hours of approved continuing respiratory care education, earned during the 2-year period preceding the expiration of the license for respiratory care, as described in §C of this regulation; (d) Being of good moral character; and (e) Meeting any additional renewal requirements set by the Board. (4) The continuing education requirement applies to all renewal applications after the first renewal. B. Reinstatement. (1) Except as provided in §B(2) of this regulation, the Board shall reinstate the license of a respiratory care practitioner if the respiratory care practitioner: (a) Completes a reinstatement application on a form supplied by the Board; (b) Pays the required reinstatement fee and any other fees set by the Board; (c) Documents evidence of at least 16 hours of approved continuing education in the 2-year period preceding the date of the submission of the application for reinstatement, as described in §C of this regulation; (d) Is of good moral character; (e) Completes a criminal history records check; and (f) Meets any additional requirements set by the Board for reinstatement of a license. (2) If the license has not been renewed for more than 5 years and the applicant has not been practicing in another jurisdiction or country during at least 3 of the 5 years preceding the application, the applicant shall pass an examination approved by the Board, and meet all the requirements of licensure at the time the respiratory care practitioner applies for reinstatement. C. Continuing Education. (1) Approved continuing respiratory care education includes: (a) Programs accredited by or sponsored by one of the following organizations: (i) Maryland/District of Columbia Society for Respiratory Care; (ii) AARC’s Continuing Respiratory Care Education System; or (iii) MedChi, the Maryland State Medical Society; or (b) Other programs: (i) Having requirements equivalent to the programs accredited through the organizations listed in §C(1)(a) of this regulation; and (ii) Approved by the Board. (2) Instead of completing the required continuing education, an applicant for renewal or reinstatement may substitute passing the examination for either the certified respiratory therapist or registered respiratory therapist conducted by the National Certifying Board during the 2-year period preceding: (a) For license renewal, the expiration of the license for respiratory care; or (b) For license reinstatement, the date of the submission of the application for reinstatement. (3) A disciplinary panel may impose a civil penalty of up to $100 per continuing respiratory care education hour in lieu of a sanction under Health Occupations Article, §14–5A–17, Annotated Code of Maryland, for a first offense, for the failure of a licensee to obtain continuing education hours required by the Board. #### Regulation .12 Fees. *COMAR 10.32.11.12* The following fees are applicable to respiratory care practitioners: A. Initial licensure fee .— $200; B. License renewal fees: (1) License renewal fee .— $150; and (2) Maryland Health Care Commission (MHCC) fee .— As determined by MHCC under COMAR 10.25.02; C. Reinstatement fee .—. $200; D. Replacement of registration card .— $25; E. Replacement of wall license .—. $75; and F. Written verification fee .—. $25. #### Regulation .13 Denials, Reprimands, Suspensions, and Revocations. *COMAR 10.32.11.13* A. Subject to the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland, a disciplinary panel, on the affirmative vote of a majority of a quorum, may deny an application for licensure, renewal, or reinstatement, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee: (1) Fraudulently or deceptively obtains or attempts to obtain a license for the applicant, licensee, or for another; (2) Fraudulently or deceptively uses a license; (3) Is guilty of unprofessional or immoral conduct in the practice of respiratory care; (4) Is professionally, physically, or mentally incompetent; (5) Abandons a patient; (6) Is habitually intoxicated; (7) Is addicted to or habitually abuses any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; (8) Provides professional services while: (a) Under the influence of alcohol; or (b) Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts or without valid medical indication; (9) Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain; (10) Willfully makes or files a false report or record in the practice of respiratory care; (11) Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report; (12) Breaches patient confidentiality; (13) Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient; (14) Knowingly makes a misrepresentation while practicing respiratory care; (15) Knowingly practices respiratory care with an unauthorized individual or aids an unauthorized individual in the practice of respiratory care; (16) Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine; (17) Is disciplined by a licensing or disciplinary authority, is convicted or disciplined by a court of any state or country, or is disciplined by any branch of the United States uniformed services or the Veterans' Administration for an act that would be grounds for disciplinary action under the Board's disciplinary statutes; (18) Fails to meet appropriate standards for the delivery of respiratory care performed in any: (a) Inpatient or outpatient facility; (b) Office; (c) Hospital or related institution; (d) Domiciliary care facility; (e) Patient's home; or (f) Other location in this State; (19) Knowingly submits false statements to collect fees for which services are not provided; (20) Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board's disciplinary statutes and the licensed individual: (a) Surrendered the license issued by the state or country; or (b) Allowed the license issued by the state or country to expire or lapse; (21) Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (22) Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes; (23) Practices or attempts to practice beyond the authorized scope of practice; (24) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; (25) Practices or attempts to practice a respiratory care procedure or uses or attempts to use respiratory care equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment; (26) Fails to cooperate with a lawful investigation conducted by the Board; or (27) Fails to practice under the supervision of a physician or violates a supervisory order of a supervising physician. (28) Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland. B. Hearing. Except as otherwise provided in the Administrative Procedure Act, before the Board takes any action under §A of this regulation, the Board shall give the individual against whom the action is contemplated an opportunity for a hearing before the Board in accordance with the hearing requirements of Health Occupations Article, §14-405, Annotated Code of Maryland. C. Crime Involving Moral Turpitude. (1) On the filing of certified docket entries with the Board by the Office of the Attorney General, the Board shall order the suspension of a license if the licensee is convicted of or pleads guilty or nolo contendere with respect to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. (2) After completion of the appellate process if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a license on the certification by the Office of the Attorney General. (3) Proceedings for crimes of moral turpitude, under Health Occupations Article, §14-5A-17(c), Annotated Code of Maryland, shall comply with COMAR 10.32.02.04. #### Regulation .14 Required Reports. *COMAR 10.32.11.14* A. Except as provided in §B of this regulation, an employer of a licensed respiratory care practitioner shall report to the Board within 10 days of the action if the employer limits, reduces, or otherwise changes the responsibilities of or terminates a licensed respiratory care practitioner for any reason that might be grounds for disciplinary action under Health Occupations Article, Title 14, Subtitle 5A, Annotated Code of Maryland, or any regulation in this chapter. B. If the action taken by an employer under §A of this regulation relates to alcohol or drug impairment, reporting shall comply with Health Occupations Article, §14-5A-18(b), (c), and (d), Annotated Code of Maryland and COMAR 10.32.22. C. A licensed respiratory care practitioner shall notify the licensed respiratory care practitioner's employer of a decision to enter an accredited alcohol or drug treatment program. D. An accredited alcohol or drug treatment program that is treating a licensed respiratory care practitioner who has given notice to his employer under §C of this regulation shall notify the employer if the licensed respiratory care practitioner is found to be noncompliant with the treatment program's policies and procedures. E. An individual is not required to make a report under this regulation that would be in violation of a federal or State law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records. #### Regulation .15 Penalties, Fines and Sanctioning Guidelines. *COMAR 10.32.11.15* A. An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5A, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000, or imprisonment not exceeding 1 year, or both. B. A disciplinary panel may impose a civil fine of not more than $5,000 on an individual who: (1) Is not licensed to practice respiratory care in Maryland and represents to the public in any way that the individual is authorized to practice respiratory care in Maryland; or (2) Violates any provision of Health Occupations Article, Title 14, Subtitle 5A, Annotated Code of Maryland. C. The Board shall deposit a penalty collected under §B of this regulation into the Board of Physicians fund. D. Employment of Unauthorized Individuals. (1) A licensed physician, hospital, related institution, alternative health system, or employer may not employ an individual practicing respiratory care without a license. (2) A licensed physician may not supervise an individual practicing respiratory care without a license. (3) A disciplinary panel may impose a fine of up to $1,000 for a violation of §D(1) or (2) of this regulation. (4) Any funds collected under §D(3) of this regulation shall be deposited into the General Fund. E. Failure to Make a Required Report. (1) A disciplinary panel may impose a fine up to $1,000 for a hospital, related institution, alternative health system, or employer who fails to make a report to the Board required by Regulation .14 of this chapter. (2) The Board shall deposit any funds collected under §E(1) of this regulation into the General Fund. F. General Application of Sanctioning Guidelines. (1) Sections F and G of this regulation and Regulation .16 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §B of this regulation, for violations of the sections of the Maryland Respiratory Care Practitioners Act listed in the sanctioning guidelines, a disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation. (c) A stayed suspension not meeting the criteria for §F(3)(b) of this regulation is ranked as a reprimand. (d) A fine listed in the sanctioning guidelines may be imposed in addition to but not as a substitute for a sanction. If a minimum fine is listed, at least the minimum fine shall be imposed in addition to the sanction listed. (e) The addition of a fine does not change the ranking of the severity of the sanction. (4) A disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and (b) A disciplinary panel may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .16 of this chapter, in order to resolve a pending disciplinary action, a disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms, sanction, and fine agreed to by a disciplinary panel, the administrative prosecutor, and the licensee. (8) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (9) If a disciplinary panel imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .16 of this chapter, a disciplinary panel shall state its reasons for doing so in its final decision and order. G. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §G(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. (3) The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (4) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (5) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. (6) A departure from the sanctioning guidelines set forth in Regulation .16 of this chapter is not a ground for any hearing or appeal of a Board action. H. In addition to any sanction authorized under this regulation, a disciplinary panel may require a licensee to comply with specified terms and conditions determined by a disciplinary panel. I. A disciplinary panel may impose a fine of $100 for a violation of Health Occupations Article, §14-5A-14, Annotated Code of Maryland. J. Offenses Related to Continuing Education Credits. (1) First Offense of Failure to Document Credits. (a) Except as provided in §I(2) or (3) of this regulation, if a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the Board may impose a civil fine under Health Occupations Article, §14-5A-13, Annotated Code of Maryland, of up to $100 per missing continuing medical education credit in lieu of a sanction under Health Occupations Article, §14-5A-17, Annotated Code of Maryland. (b) Section I(1)(a) of this regulation does not limit the Board's authority to require completion of the missing continuing medical education credits. (2) Willful Falsification. (a) If a licensee has willfully falsified an application with respect to continuing education credits, the licensee may be charged under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5A-17(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5A-17(a)(10), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-5A-17(a)(11), Annotated Code of Maryland. (b) Upon a finding of a violation, a disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5A-17, Annotated Code of Maryland, and the sanctioning guidelines. (3) Licensees Previously Disciplined Under §I(1) or (2) of this Regulation. (a) If a licensee has been previously fined or otherwise disciplined under §I(1) or (2) of this regulation, the Board may, for a subsequent offense relating to continuing education credits, charge a licensee under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5A-17(a)(3), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5A-17(a)(10), Annotated Code of Maryland; and (iii) Health Occupations Article, §14-5A-17(a)(11), Annotated Code of Maryland. (b) Upon a finding of a violation, a disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5A-17, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense. (c) The Board may not apply the sanction described in §J(1) of this regulation in determining a sanction for a licensee previously fined or disciplined for an offense related to continuing education credits. (4) The Board shall pay all monies collected pursuant to §I of this regulation into the Board of Physicians Fund. K. Payment of Fines. (1) An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise. (2) Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation. (3) If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full. (4) In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. #### Regulation .16 Sanctioning Guidelines for Respiratory Care Practitioners. *COMAR 10.32.11.16* A. Subject to provisions of Regulation .15F and G of this chapter, the Board may impose sanctions as outlined in §B of this regulation on respiratory care practitioners for violations of Health Occupations Article, §14-5A-17(a), Annotated Code of Maryland. B. Range of Sanctions. ### Chapter 12 — Delegation of Acts by a Licensed Physician **Authority:** Health General Article, §§19-114 and 19-118; Health Occupations Article, §§14-205(a) and 14-306; Annotated Code of Maryland **Administrative History:** Effective date: June 12, 2000 (27:11 Md. R. 1078) **Administrative History:** Regulation .01 amended effective December 27, 2021 (48:26 Md. R. 1112) **Administrative History:** Regulation .02B amended effective September 2, 2002 (29:17 Md. R. 1380); March 14, 2016 (43:5 Md. R. 386); December 27, 2021 (48:26 Md. R. 1112) **Administrative History:** Regulation .03 amended effective December 27, 2021 (48:26 Md. R. 1112) **Administrative History:** Regulation .04 amended effective September 2, 2002 (29:17 Md. R. 1380); December 27, 2021 (48:26 Md. R. 1112) **Administrative History:** Regulation .04D amended effective March 14, 2016 (43:5 Md. R. 386) **Administrative History:** Regulation .04E, F amended effective March 26, 2018 (45:6 Md. R. 320) **Administrative History:** Regulation .05 amended effective December 27, 2021 (48:26 Md. R. 1112) **Administrative History:** Regulation .06 adopted effective December 27, 2021 (48:26 Md. R. 1112) **Administrative History:** Regulation .07 adopted effective December 27, 2021 (48:26 Md. R. 1112) #### Regulation .01 Scope. *COMAR 10.32.12.01* A. This chapter governs the delegation of technical acts by a licensed physician to an: (1) Assistant not otherwise authorized under the Health Occupations Article or the Education Article, Annotated Code of Maryland; and (2) RCIS assisting in the physician's performance of fluoroscopy during a cardiac catheterization procedure under certain circumstances as authorized under Regulation .06 of this chapter. B. This chapter may not be construed: (1) As establishing the licensure, certification, or registration by the Board of assistants or registered cardiovascular invasive specialists; (2) To apply to certified, registered, or licensed professionals, or health occupation students acting pursuant to Health Occupations Article, Annotated Code of Maryland; and (3) To mean that this chapter overrides or is to be used in lieu of more stringent regulations, policies, and procedures established by State licensure or certification requirements or Board-recognized accrediting agencies. #### Regulation .02 Definitions. *COMAR 10.32.12.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Assistant” means an individual to whom only routine technical acts are delegated by a licensed physician and who is: (a) Trained as defined in §B(17) of this regulation and not certified, registered, or licensed by the Board or any other State health occupation board; or (b) Certified, registered, or licensed by the Board or any other State health occupation board and is not acting under the authority of that certification, registration, or license granted by a State health occupation board. (2) “Board” means the State Board of Physicians. (3) “CLIA” means the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. §263a) and the regulations promulgated under them, and 42 CFR Part 493, Subparts B and M. (4) “Delegating physician” means a physician possessing an active license to practice medicine in this State who directs an assistant or RCIS to perform technical acts. (5) “Direct supervision” means oversight exercised by a delegating physician who is: (a) Personally treating the patient; and (b) In the presence of the patient and the: (i) Assistant; or (ii) RCIS. (6) “Fluoroscopy” means a technique for generating x-ray images and presenting them simultaneously and continuously as visible images. (7) “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. (8) “Licensed physician” means, unless the context requires otherwise, a physician, including a doctor of osteopathy, who is licensed by the Board to practice medicine. (9) “MDE” means the Maryland Department of the Environment. (10) “Microdermabrasion” means the use of a minimally invasive technique to gently exfoliate the dead, outermost layer of skin and is a method for improving superficial, environmental, aging, and hereditary skin changes by superficial, mechanically powered abrasion, often combined with application of topical crystals such as vitamin C. (11) “On-site supervision” means oversight exercised by a delegating physician who is present at the site and able to be immediately available in person during the course of the performance of a delegated act. (12) “Perform fluoroscopy” means the energizing of a fluoroscopic x-ray system by an individual authorized in accordance with MDE regulations. (13) “Readily retrievable” means maintained in a method by which a hospital can retrieve and produce the record for the Board upon request. (14) “Registered cardiovascular invasive specialist (RCIS)” means an individual who is credentialed by Cardiovascular Credentialing International or another credentialing body approved by the Board to assist in cardiac catheterization procedures under the direct, in-person supervision of a licensed physician. (15) “Site” means any facility or location including those defined in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, used for the delivery of health services not covered in this chapter. (16) “Technical act” means a routine medical or surgical act which does not require medical judgment and is performed with the supervision as specified within this chapter. (17) “Trained” means possessing the knowledge, skills, and abilities, as determined by the licensed physician, to perform delegated acts. #### Regulation .03 Standards for the Licensed Physician Delegating to an Assistant. *COMAR 10.32.12.03* A. A licensed physician who delegates shall: (1) Evaluate the risk to the patient and the outcome of the delegated acts; (2) Delegate only those technical acts that are customary to the practice of the licensed physician; (3) Delegate only those technical acts for which the assistant has been trained; (4) Be responsible for the acts of the assistant; and (5) Supervise the assistant. B. The responsibility for the delegated act cannot be transferred from the delegating physician to another licensed physician without: (1) The expressed consent of the other physician; and (2) Informing the assistant. #### Regulation .04 Scope of Delegation to an Assistant. *COMAR 10.32.12.04* A. A licensed physician may not delegate to an assistant technical acts which are exclusively limited to any individual required to be licensed, certified, registered, or otherwise recognized pursuant to any provision of the Health Occupations Article and the Education Article, Annotated Code of Maryland. B. A licensed physician may delegate technical acts consistent with national standards in the medical community and the approved policies and procedures of the sites for the delivery of health services in the following categories: (1) Surgical technical acts that the delegating physician directly orders while present, scrubbed, and personally performing the surgery in the same surgical field; and (2) Nonsurgical technical acts while the assistant is under the licensed physician's direct supervision or on-site supervision if the assistant performs the act in accordance with procedures of the site. C. At sites included in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, or any unit of those sites, a licensed physician may delegate technical acts in compliance with State regulations and the policies, procedures, and supervisory structures of those sites. D. At sites not included in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, when providing the following specified levels of supervision, a licensed physician may delegate to an assistant technical acts which include but are not limited to: (1) Without on-site supervision: (a) Patient preparation for physician examination; (b) Patient history interview; (c) Collecting and processing specimens, such as performing phlebotomy and inoculating culture media; (d) Preparation of specimens for selected tests including: (i) Pregnancy tests; (ii) Dipstick and microscopic urinalysis; and (iii) Microbiology (rapid streptococcal testing and throat cultures); (e) Laboratory tests that the licensed physician is satisfied the assistant is qualified to perform under State and CLIA regulations; (f) Clinical tests such as: (i) Application of tuberculin skin tests; (ii) Electrocardiography; (iii) Administering basic pulmonary function tests; and (iv) Visual field tests; (g) Transmitting prescriptions to a pharmacy; (h) Providing sample packets of medication, selected by a licensed physician who is physically present at the time of selection, to patients as directed by the delegating physician and in conformance with Health Occupations Article, §12-102(a), (d), and (f), Annotated Code of Maryland; (i) Preparing and administering oral drugs; and (j) Microdermabrasion; (2) With on-site supervision: (a) Preparing and administering injections limited to intradermal, subcutaneous, and intramuscular (deltoid, gluteal, vastus lateralis) to include small amounts of local anesthetics; (b) Establishing a peripheral intravenous line; and (c) Injecting fluorescein-like dyes for retinal angiography; and (3) With direct supervision, injecting intravenous drugs or contrast materials. E. A licensed physician who possesses a dispensing permit may delegate the dispensing functions in accordance with the requirements of COMAR 10.32.23. F. A licensed physician may not delegate to an assistant acts which include but are not limited to: (1) Conducting physical examinations; (2) Administering any form of anesthetic agent or agent of conscious sedation other than topical anesthetics or small amounts of local anesthetics; (3) Initiating independently any form of treatment, exclusive of cardiopulmonary resuscitation; (4) Giving medical advice without the consult of a licensed physician; and (5) Providing physical therapy. #### Regulation .05 Prohibited Conduct and Penalties. *COMAR 10.32.12.05* A. An assistant or RCIS acting beyond the scope of this chapter may be: (1) Considered to be engaged in the unlicensed practice of medicine; and (2) Subject to all applicable penalties and fines in accordance with Health Occupations Article, §§14-602 and 14-607, Annotated Code of Maryland, and COMAR 10.32.02. B. A delegating physician, through either act or omission, facilitation, or otherwise enabling or forcing an assistant or RCIS to practice beyond the scope of this chapter, may be subject to discipline for grounds within Health Occupations Article, §14-404(a), Annotated Code of Maryland, including, but not limited to, practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine. C. A delegating physician may not: (1) Require an assistant or RCIS to perform a delegated act; or (2) Permit an assistant or RCIS to delegate any act to another individual. D. A hospital that fails to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter may be assessed a civil penalty of up to $5,000 for each instance. #### Regulation .06 RCIS Assistance in the Delegating Physician’s Performance of Fluoroscopy. *COMAR 10.32.12.06* A. Scope of Regulation. (1) This regulation governs: (a) A licensed physician’s delegation of technical acts to an RCIS assisting in the physician’s performance of fluoroscopy provided the delegation is in accordance with the entirety of this chapter; and (b) The responsibilities of the hospital in which the cardiac catheterization laboratory is located to verify and document the qualifications of an RCIS and to ensure that all requirements of Health Occupations Article, §14-306, Annotated Code of Maryland and this regulation are met for each procedure. (2) This regulation does not limit a licensed physician from delegating technical acts to an RCIS who is not assisting in the physician’s performance of fluoroscopy provided the delegation is in accordance with Regulations .01—.05 of this chapter. B. An RCIS assisting in a delegating physician’s performance of fluoroscopy shall: (1) Possess an active RCIS certification issued by Cardiovascular Credentialing International or another credentialing body approved by the Board; (2) Complete 40 hours of: (a) Accredited didactic education in fluoroscopic radiation physics and fluoroscopic patient safety; and (b) Clinical fluoroscopic training supervised by a radiologist, radiographer, or radiologist assistant who is physically present in the room with the RCIS to instruct the clinical fluoroscopic training; (3) In the hospital, wear an identification badge displaying in readily visible type: (a) The name of the RCIS; and (b) A designation by the hospital of verification of the RCIS’ credentials and completion of requirements to assist in a physician’s performance of fluoroscopy; and (4) Comply with any additional requirements as established by: (a) MDE; (b) The Joint Commission; and (c) Federal and State laws and regulations. C. Responsibilities. (1) The hospital shall: (a) Verify that the RCIS has met the requirements in §B of this regulation before permitting an RCIS to assist in a delegating physician’s performance of fluoroscopy; (b) Issue to the RCIS an identification badge in accordance with §B(3) of this regulation; (c) Keep on-site all documentation of the RCIS’ certification and the additional training required under this regulation; (d) Permit the Board, at any reasonable hour, to inspect the hospital’s documentation of the RCIS’ certification and training to ensure compliance with this regulation; (e) Regarding radiation machines and fluoroscopy services, comply with any additional requirements as established by: (i) MDE; (ii) The Joint Commission; and (iii) Federal and State laws and regulations; and (f) Verify that the acts delegated to the RCIS are in accordance with the scope of this chapter. (2) The delegating physician shall: (a) Exercise direct supervision of the RCIS when the RCIS is assisting the delegating physician in the delegating physician’s performance of fluoroscopy; (b) Delegate only technical acts involved in the physician’s performance of fluoroscopy in accordance with Regulation .03 of this chapter; and (c) Verbally direct each technical act performed by the RCIS. (3) The RCIS: (a) May not perform fluoroscopy; (b) Shall perform technical acts to assist the delegating physician in the delegating physician’s performance of fluoroscopy only upon verbal direction from the delegating physician; (c) May not delegate any act to another individual; and (d) May not engage in prohibited conduct as set out in Regulation .05 of this chapter. #### Regulation .07 Enforcement. *COMAR 10.32.12.07* A. The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter. B. Any matter regarding a hospital’s failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and Regulation .06 of this chapter shall be adjudicated in accordance with COMAR 10.32.02. ### Chapter 13 — Physician License by Conceded Eminence **Authority:** Health Occupations Article, §§14-205, 14-206, 14-301, 14-302, and 14-307—319, Annotated Code of Maryland; Chapter 273 (1993) **Administrative History:** Effective date: November 22, 1993 (20:23 Md. R. 1804) **Administrative History:** Regulation .02B amended effective January 1, 2018 (44:26 Md. R. 1215); October 22, 2018 (45:21 Md. R. 975); August 26, 2019 (46:17 Md. R. 727) **Administrative History:** Regulation .03 amended effective January 1, 2018 (44:26 Md. R. 1215); October 22, 2018 (45:21 Md. R. 975) **Administrative History:** Regulation .04 amended effective January 1, 2018 (44:26 Md. R. 1215) **Administrative History:** Regulation .06 amended effective January 1, 2018 (44:26 Md. R. 1215) **Administrative History:** Regulation .08 amended effective January 1, 2018 (44:26 Md. R. 1215) #### Regulation .01 Scope. *COMAR 10.32.13.01* These regulations establish the qualifications for an individual to become licensed in Maryland to practice medicine by virtue of conceded eminence and authority in the profession and to set limits on the license. #### Regulation .02 Definitions. *COMAR 10.32.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ABMS or other equivalent specialty board” means the American Board of Medical Specialties or equivalent boards in other countries. (2) “Applicant” means an individual applying for initial licensure as a physician in Maryland. (3) “Application period” means the time between the filing of an application and the issuance of a license or denial of the application. (4) “Board” means the Board of Physicians. (5) “Conceded eminence and authority in the profession” means significant teaching, research, and achievement in a field of medicine recognized by the Board. (6) “First author” means the first named author of a publication such as a research article or the author who served as the principal investigator for a research project. (7) “Index Medicus” means an international list of periodicals concerning the practice of medicine. (8) “Last author” means the last named author of a publication such as a research article or the senior author who served as the principal investigator for a research project. (9) “LCME” means Liaison Committee on Medical Education of the American College of Medical Education and the American Medical Association. (10) “LMCC” means Licentiate of the Medical Council of Canada, or its successor. (11) “Malpractice history” means a list of claims filed against a health care provider for damage due to medical injuries as described in Courts and Judicial Proceedings Article, Title 3, Subtitle 2A, Annotated Code of Maryland, or adverse action reports made to the National Practitioner Data Bank of the federal government, or both. (12) “Medical licensing examination results” means scores or results of examinations such as the: (a) Educational Commission for Foreign Medical Graduates (ECFMG), or its successor; (b) Federation Licensing Examination (FLEX) designed by the Federation of State Medical Boards; (c) National Board of Medical Examiners (NBME); (d) United States Medical Licensing Examination (USMLE) designed by the Federation of State Medical Boards; and (e) Special Purpose Examination prepared by the Federation of State Medical Boards (SPEX). (13) “Postgraduate training” means, for the purpose of conceded eminence applicants, clinical and medical training for medical school graduates, including but not limited to, internships, residencies, and fellowships. (14) “Speech impairment” means a disorder of the voice, in articulation of speech sounds, or nonfluency in the speaker's native language. (15) “World Health Organization directory” means the World Directory of Medical Schools, an international list of recognized medical schools compiled by the World Health Organization agency of the United Nations. #### Regulation .03 Qualifications for Special License by Conceded Eminence. *COMAR 10.32.13.03* A. An applicant shall: (1) Complete an application on a form supplied by the Board; (2) Pay an application fee set by the Board in COMAR 10.32.01.12; (3) Be of good moral character; and (4) Be at least 18 years old. B. Recommendations. On a form supplied by the Board, the dean of a school of medicine in the State or the director of the National Institutes of Health shall recommend the applicant to the Board, by: (1) Attesting to the fact that the applicant is to receive an appointment at the institution represented by the dean or director; (2) Presenting the Board with detailed evidence of the physician’s qualifications and competence including: (a) The nature of the physician's proposed responsibilities; (b) Reasons for any limitations of the physician's practice responsibilities; and (c) The degree of supervision under which the physician will function; and (3) Presenting the Board with a detailed statement describing the applicant’s conceded eminence and authority in the profession. C. Evidence of Teaching, Research, and Achievement. An applicant shall demonstrate eminence and authority in the profession by meeting the following qualifications: (1) Have held an appointment at a medical school approved by the LCME or at any medical school listed in the World Health Organization directory at the level of associate or full professor, or its equivalent, for at least 5 years; (2) Have actively practiced medicine cumulatively for 10 years after completion of postgraduate training, including clinical research; (3) Be a member in good standing of a board of the American Board of Medical Specialties or other equivalent specialty board; (4) Possess a current, active, unrestricted license to practice medicine in another state or country, or be otherwise recognized under the laws of the other country or jurisdiction as a medical doctor in that jurisdiction; and (5) Within 10 years before the application: (a) Have: (i) Published original results of clinical research, as first author or last author, in a medical journal listed in the Index Medicus or in an equivalent scholarly publication acceptable to the Board; and (ii) Submitted these articles to the Board in English or in a foreign language with verifiable, certified translations in English; or (b) Have developed a treatment modality, surgical technique, or other verified original contribution to the field of medicine, which is attested to by the dean of a school of medicine in the State or by the director of the National Institutes of Health. D. Supervision. The Board shall require an applicant to submit: (1) The name of a licensed physician who will supervise the medical services provided by the applicant for the first 6 months of practice; and (2) A detailed description of the medical services, duties, and responsibilities that the applicant will perform. E. Additional Requirements for License by Conceded Eminence and Authority in the Profession. (1) The Board may require additional information which includes, but is not limited to, the following: (a) A letter from the chief of staff of any hospital where the applicant has practiced within the 5 years preceding the application for license under this chapter, detailing the applicant's competence to practice medicine; (b) A detailed description of activities including, but not limited to, the following: (i) Any action, by any state licensing or disciplinary board, or any comparable body in the armed services, denying an application for licensure, reinstatement, or renewal; (ii) Any action taken against the physician's license, by any state licensing or disciplinary board, or any comparable body in the armed services, including but not limited to limitations of practice, required education, admonishment, reprimand, suspension, or revocation for an act that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (iii) Any investigations or charges brought against the physician by any licensing or disciplinary body or comparable body in the armed services; (iv) Any medical or health professional licenses for which the physician has applied when the application was withdrawn for reasons that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (v) Any investigations or charges brought against the physician by any hospital, related institution, or alternative health care system that might be grounds for action under Health Occupations Article, §14-404, Annotated Code of Maryland; (vi) Any limitations or loss in privileges by any hospital, related health care facility, or alternative health care system that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (vii) Any pleas of guilty or nolo contendere, or convictions, or receipt of probation before judgment for any criminal act; (viii) Any pleas of guilty or nolo contendere, or convictions, or receipt of probation before judgment for any alcohol or controlled dangerous substance offense including, but not limited to, driving while under the influence of alcohol or controlled dangerous substances; (ix) Any arrests which would provide a basis for investigation or charges that would be grounds for disciplinary action under Health Occupations Article, §14-404, Annotated Code of Maryland; (x) Any illness or condition which has impaired the physician's ability to practice medicine within the 3 years before, or during the pendency of, the application; (xi) Any treatment for alcohol abuse, substance abuse, or chemical dependence; and (xii) The filing or settling of any medical malpractice actions in which the physician is, or has been, named as a defendant; (c) Malpractice history; (d) Driving record, including but not limited to convictions for driving while intoxicated or while under the influence of any chemical substance or medication; (e) Medical licensing examination results; (f) Physical or mental examinations, or both, by a physician or evaluation program for treatment of impaired physicians, or both, chosen by the Board. (2) On forms supplied by the Board, an applicant shall: (a) Agree to release to the Board information from other institutions and government agencies including, but not limited to, the National Practitioner Data Bank, hospitals, and other licensing bodies; and (b) Allow the Board to release information which is not statutorily protected. (3) An applicant for licensure under this chapter shall agree to inform the Board by certified mail, return receipt requested, within 30 days of receiving notice of any action listed in this section. F. English Language Competency. An applicant shall demonstrate oral and written English language competency as described in COMAR 10.32.01.04D. G. Claim of Speech Impairment. An applicant wishing to claim a speech impairment shall submit documentation of this impairment on forms supplied by the Board as described in COMAR 10.32.01.04E. H. Withdrawals. An application may not be withdrawn if the applicant is under investigation or charges for reasons that may be grounds under Health Occupations Article, §14-404, Annotated Code of Maryland, if the applicant were licensed in this State. #### Regulation .04 Limited Practice. *COMAR 10.32.13.04* An applicant for licensure is restricted so that the applicant shall: A. Practice medicine only in the limited field approved by the Board that is consistent with the applicant’s area of conceded eminence experience; B. For the first 6 months of practice, practice medicine only: (1) Within the institution and program specified within the application; and (2) Under the supervision of a licensed physician; C. Following the first 6 months of practice, practice medicine only: (1) At an institution similar to that named in the original application; and (2) After approval by the Board; and D. Practice medicine under any conditions which the Board may set. #### Regulation .05 Unrestricted License. *COMAR 10.32.13.05* Nothing in these regulations entitles an individual licensed by conceded eminence in the profession to practice beyond the scope of these regulations without having qualified for an unrestricted license under Health Occupations Article, §14-307 or 14-308, Annotated Code of Maryland, and regulations promulgated under those sections. #### Regulation .06 Term and Renewal of License by Conceded Eminence and Authority in the Profession. *COMAR 10.32.13.06* A. Term and Tenure. (1) The initial license is active for a period 1 year, and, after that, may be renewed twice for a term established by the Board. After two renewals, a licensee seeking any additional renewals shall provide documentation to the Board 3 months before the expiration of the licensee’s license indicating the continued significance of the licensee’s work at the sponsoring institution that requires the license to be renewed for another term. (2) Unless the Board has been advised and approves of an appointment at a new institution, a license issued under this regulation expires immediately when an individual leaves the appointment at the sponsoring institution. B. Initial Renewal. As part of the initial renewal process: (1) The supervising physician shall submit an attestation, approved by the Board, that the licensee was supervised for a period of at least 6 consecutive months; and (2) The licensee shall complete a renewal application form, after Board approval of the attestation. C. Second Renewal. (1) A license issued under this chapter may be renewed in a second renewal: (a) On a date set by the Board; and (b) As specified in COMAR 10.32.01. (2) A licensee for second renewal shall: (a) Complete a renewal application form; (b) Meet the requirements set out in COMAR 10.32.01.10, including completing at least 50 hours of continuing medical education units; and (c) Pay a renewal fee set by the Board in COMAR 10.32.01.12. (3) A licensee shall inform the Board of the institution where the licensee plans on practicing for the renewal term. D. Subsequent Renewal. (1) A license issued under this chapter may be renewed in subsequent renewals: (a) On a date set by the Board; and (b) As specified in COMAR 10.32.01.12. (2) A license for subsequent renewal shall: (a) Complete a renewal application form; (b) Meet the requirements set out in COMAR 10.32.01.10, including completing at least 50 hours of continuing medical education units; (c) Provide documentation to the Board 3 months before the expiration of the licensee’s license indicating the continued significance of the licensee’s work at the sponsoring institution that requires the license to be renewed for another term; and (d) Pay a renewal fee set by the Board in COMAR 10.32.01.12. (3) A licensee shall inform the Board of the institution where the licensee plans on practicing for the renewal term. #### Regulation .07 Licensure Required. *COMAR 10.32.13.07* Practicing medicine beyond the scope of these regulations, including practicing without notifying the Board and without approval of the Board at any institution or place outside the institution approved by the Board, constitutes practicing without a license under Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland. #### Regulation .08 Termination and New Appointment. *COMAR 10.32.13.08* A. On termination of the licensee’s approved appointment, the conceded eminence license terminates and becomes null and void. B. A licensee has a duty to inform the Board of the termination of an appointment within 30 days of the termination. C. Failure of the licensee to inform the Board of the termination of an appointment within 30 days constitutes unprofessional conduct under Health Occupations Article, §14-404(a)(3), Annotated Code of Maryland. D. New Appointment. (1) If a licensee wishes to receive a conceded eminence license with another institution, the licensee shall apply for a new appointment with another institution. (2) The Board may approve the new appointment at the Board’s discretion. (3) Board approval shall be obtained before the individual may begin the appointment. ### Chapter 14 — Unlicensed Limited X-Ray Machine Operator **Authority:** Health Occupations Article, §§14-205, 14-207, 14-306, and 14-308.1, Annotated Code of Maryland **Administrative History:** Effective date: April 25, 1994 (21:8 Md. R. 674) **Administrative History:** Regulation .01 amended effective March 1, 2004 (31:4 Md. R. 316); August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .02 adopted effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .03 adopted effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .04 adopted effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .05 adopted effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .06 adopted effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .07 adopted effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .08 adopted effective August 18, 2025 (52:16 Md. R. 846) **Administrative History:** Regulation .09 adopted effective August 18, 2025 (52:16 Md. R. 846) #### Regulation .01 Scope. *COMAR 10.32.14.01* A. This chapter governs the performance of certain X-ray duties without a license to a registered Limited X-ray Machine Operator. B. This chapter may not be construed to: (1) Apply to certified, registered, or licensed professionals or health occupation students acting pursuant to Health Occupations Article, Annotated Code of Maryland; and (2) Mean that this chapter overrides or is to be used in lieu of more stringent regulations, policies, and procedures established by State licensure or certification requirements or Board-recognized accrediting agencies. #### Regulation .02 Definitions. *COMAR 10.32.14.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ARRT” means American Registry of Radiologic Technologists. (2) “Authorized supervisor” means a Maryland licensed physician or a Maryland licensed radiologic technologist. (3) “Board” means the State Board of Physicians. (4) “Certified radiologic technologist” means an individual who holds an active license and is certified in radiologic technology by the ARRT. (5) “Competency” means the successful completion of supervised clinical procedures to verify the individual’s professional knowledge, skills, and ability. (6) “Direct supervision” means oversight exercised by an authorized supervisor who is in the physical presence of the unlicensed individual and is able to provide instruction during the performance of an X-ray procedure. (7) “Licensed physician” means, unless the context requires otherwise, a physician, including a doctor of osteopathy, licensed by the Board to practice medicine in the State. (8) “Licensed radiologic technologist” means, unless the context requires otherwise, an individual licensed by the Board as a radiographer in the State. (9) Limited Scope X-ray Educational Program. (a) “Limited scope X-ray educational program” means an educational program that meets the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland. (b) “Limited scope X-ray educational program” is not a radiography educational program. (10) “LXMO” means a Limited X-Ray Machine Operator registered with the Board. (11) “Immediately available supervision" means oversight exercised by an authorized supervisor who can be immediately available to provide direction in person, by telephone, or by other electronic means. (12) “Readily retrievable” means maintained in a method by which an office can retrieve and produce the record for the Board upon request. #### Regulation .03 Application, Renewal, and Reinstatement. *COMAR 10.32.14.03* A. To apply for LXMO registration, an applicant shall: (1) Pay the fee determined by the Board established in Regulation .09 of this chapter; and (2) Complete a form provided by the Board attesting to: (a) Completion of at least 6 months of clinical care experience; (b) Completion of a limited scope X-ray educational program consisting of at least 115 hours of didactic training delivered by a certified radiologic technologist providing instruction in: (i) Radiographic anatomy, procedures, and pathology; (ii) Digital image acquisition and display; (iii) Fundamentals, ethics, and laws of health care; (iv) Human anatomy and physiology; (v) Image production and analysis; (vi) Imaging equipment and radiation production; (vii) Medical terminology; and (viii) Patient care; (c) Completion of at least 480 hours of clinical training performed under the direct supervision of a certified radiologic technologist; (d) Completion of a minimum of five competencies in each body part listed in Regulation .06B(2) of this chapter performed under the direct supervision of a certified radiologic technologist; and (e) Achievement of a passing result of 75 percent or higher on the ARRT Examination for Limited Scope of Practice in Radiography or a passing result on an alternative exam as determined by the Board. (3) Criminal History Records Check. An applicant shall submit to a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, by submitting to the Central Repository: (a) Two complete sets of legible fingerprints taken on forms approved by the Central Repository and the Federal Bureau of Investigation; and (b) All fees required by the Central Repository and the Federal Bureau of Investigation. B. Renewal. (1) Before the expiration of the registration, an individual applying for renewal shall complete an application for renewal on the form supplied by the Board. (2) LXMO registration shall be renewed every 2 years on the date set by the Board. (3) An LXMO shall pay the renewal fee, and any additional charges set by the Board in accordance with Regulation .09 of this chapter. (4) An LXMO shall attest to the completion of continuing education activities as specified in Regulation .04 of this chapter. (5) The Board may request an LXMO to submit evidence of having met the continuing education requirement specified in Regulation .04 of this chapter. (6) If an LXMO cannot demonstrate completion of the required continuing education credit hours, the Board may impose a civil penalty of up to $100 per missing continuing education hour. (7) If an LXMO fails to renew their registration for any reason, the registration will expire. (8) After the expiration of the registration, an individual is no longer authorized to practice as an LXMO. (9) The Board may impose a civil penalty of up to $1,000 on the individual and a civil penalty of up to $5,000 on the employer of the individual for practicing without registration if a formerly registered individual: (a) Fails to submit an application and pay the requisite renewal fee before the expiration of the registration; and (b) Practices as a LXMO after the expiration of the registration. C. Reinstatement. (1) The Board shall reinstate the registration of an LXMO if the individual: (a) Completes the reinstatement application on the form approved by the Board. (b) Pays a reinstatement fee as determined by the Board in accordance with Regulation .09 of this chapter; and (c) Documents evidence of completion of at least 24 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement for the registration as an LXMO. (2) The applicant shall submit to a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, by submitting to the Central Repository: (a) Two complete sets of legible fingerprints taken on forms approved by the Central Repository and the Federal Bureau of Investigation; and (b) All fees required by the Central Repository and the Federal Bureau of Investigation. #### Regulation .04 Continuing Education. *COMAR 10.32.14.04* A. An LXMO shall complete at least 24 hours of approved continuing education credits earned during the 2 years preceding the expiration of the registration. B. Approved continuing education is as follows: (1) In-service programs at a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a health maintenance organization certified by the State; or (2) Programs relevant to the practice of an LXMO approved by the: (a) Maryland Society of Radiologic Technologists; (b) American Medical Association; (c) MedChi, the Maryland State Medical Society; or (d) American Society of Radiologic Technologists. C. An LXMO shall obtain documentation of continuing education attendance and retain this documentation for the succeeding 6 years for possible inspection by the Board. D. The required documentation of attendance at a continuing education course shall contain, at a minimum: (1) Program title; (2) Sponsor’s name; (3) LXMO’s name; (4) Inclusive date or dates and location of the continuing education event; (5) Number of designated continuing education hours; and (6) Documented verification of a successful completion. #### Regulation .05 Physician Office Requirements. *COMAR 10.32.14.05* A. An LXMO shall wear an identification badge while on-site that states in readily visible type: (1) The name of the LXMO; and (2) The title “Limited X-Ray Machine Operator.” B. A physician’s office employing an LXMO shall: (1) Issue the LXMO an identification badge described in §A of this regulation; (2) Verify all credentials of the LXMO; (3) Keep readily retrievable, on-site documentation that the LXMO meets the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter; (4) Permit the Board to inspect the documentation to ensure compliance with Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter; and (5) Verify all X-ray examinations performed by the LXMO are in accordance with Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter. #### Regulation .06 Scope of Practice. *COMAR 10.32.14.06* A. An LXMO shall perform X-ray duties in a physician’s office under the immediately available supervision of a licensed physician or licensed radiologic technologist and in accordance with §B of this regulation. B. An individual registered as an LXMO may perform X-ray duties without a license only if the duties: (1) Do not include: (a) Computerized or non-computerized tomography; (b) Fluoroscopy; (c) Invasive radiology; (d) Mammography; (e) Nuclear medicine; (f) Radiation therapy; or (g) Xerography; and (2) Are limited to X-ray procedures of the: (a) Chest; (b) Spine, including the: (i) Cervical spine; (ii) Lumbar spine; (iii) Sacroiliac joints; (iv) Sacrum and coccyx; and (v) Thoracic spine; (c) Lower extremities, including: (i) Toes; (ii) The foot; (iii) The ankle; (iv) The calcaneus; (v) The tibia and fibula; (vi) The knee and patella; and (vii) The femur; and (d) Upper extremities, including: (i) Fingers; (ii) The hand; (iii) The wrist; (iv) The forearm; (v) The elbow; (vi) The humerus; (vii) The shoulder; (viii) The clavicle; (ix) Acromioclavicular joints; and (x) The scapula. #### Regulation .07 Prohibited Conduct and Penalties. *COMAR 10.32.14.07* A. An LXMO acting beyond the scope of this chapter may be: (1) Considered to be engaged in the unlicensed practice of radiography; and (2) Subject to all applicable penalties and fines in accordance with Health Occupations Article, §§14-601, 14-602 and 14-5B-17, Annotated Code of Maryland, and COMAR 10.32.02. B. A supervising licensed physician or licensed radiologic technologist, through either act or omission, facilitation, or otherwise enabling or forcing an LXMO to practice beyond the scope of this chapter, may be subject to discipline for grounds within Health Occupations Article, §§14-404(a) or 14-5B-14, Annotated Code of Maryland, including, but not limited to, practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine. C. A supervising licensed physician or licensed radiologic technologist may not: (1) Require an LXMO to perform an X-ray procedure; and (2) Permit an LXMO to delegate to another individual. D. A physician’s office that employs an individual authorized to perform X-ray duties without a license is responsible for ensuring that all requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter are met for each X-ray examination performed. #### Regulation .08 Enforcement. *COMAR 10.32.14.08* A. The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter. B. The Board may impose a civil penalty of up to $5,000 per incident on a physician’s office for failure to comply with Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter. C. The Board may impose a civil penalty of up to $5,000 per incident on a physician's office who employs an unregistered individual to practice as an LXMO. D. The Board may impose a civil penalty of up to $1,000 per incident on an individual for failure to comply with Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter. #### Regulation .09 Fees. *COMAR 10.32.14.09* The following fees are applicable to LXMOs: A. Application for initial registration—$65; B. Renewal Fees: (1) Renewal of registration fee—$125; and (2) Maryland Health Care Commission (MHCC) fee—As determined by MHCC in accordance with COMAR 10.25.03; C. Reinstatement of registration fee—$135; D. Application to take the Limited Scope of Practice in Radiology examination—$10; E. LXMO registration fee per month until expiration of initial registration—$2; and F. Written verification fee—$25. ### Chapter 15 — Registration of Physicians to Perform Acupuncture **Authority:** Health Occupations Article, §14-504, Annotated Code of Maryland **Administrative History:** Effective date: September 11, 1995 (22:18 Md. R. 1400) #### Regulation .01 Definitions. *COMAR 10.32.15.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Applicant” means a physician who has applied to the Board for registration to perform acupuncture in this State. (2) “Board” means the State Board of Physicians. (3) “Medical acupuncture course of study” means a sequence of study in acupuncture approved by the Board, which sequence may consist of combinations of course work from unrelated institutions completed within 5 years of the date of application, that includes at least 200 hours of instruction in general and basic aspects, specific uses and techniques of acupuncture, and indications and contraindications of acupuncture administration. (4) “Medical acupuncture program” means a program of study in acupuncture which has been approved for Category I continuing medical education credit by an institution accredited or recognized by the Accreditation Council on Continuing Medical Education to conduct Category I continuing medical education courses. (5) “Physician” means an individual licensed to practice medicine in Maryland. (6) “To perform acupuncture” means to stimulate a certain point or points on or near the surface of the human body by the insertion of needles to prevent or modify the perception of pain or to normalize physiological functions, including pain control, for the treatment of ailments or conditions of the body and for maintenance of good health. #### Regulation .02 Application. *COMAR 10.32.15.02* To qualify for registration, a physician shall: A. Complete an application on a form supplied by the Board, enclosing: (1) Required supplementary materials, which are in English, and (2) English translations of certified, required documentation with costs borne by the applicant; B. Pay a registration fee of $150; C. Submit a current, signed passport-sized photograph; D. Be a licensed physician; and E. Submit evidence of having successfully completed 200 hours of training in a medical acupuncture program or course of study, including any required examinations. #### Regulation .03 Unprofessional Conduct. *COMAR 10.32.15.03* Unprofessional conduct in the practice of medicine includes the failure of a physician to: A. Comply with the statute and regulations governing physicians who perform acupuncture, and includes representing oneself as a registered acupuncturist without having met all the previous requirements; and B. Be registered by the Board, or to have met all the requirements of Health Occupations Article, §§1A-101 — 1A-502 and §14-302(4) — (5), Annotated Code of Maryland. #### Regulation .04 Advertising. *COMAR 10.32.15.04* A. A physician who has been registered by the Board to perform acupuncture may advertise services subject to the provisions of this regulation. B. An advertisement may not express statements: (1) Containing misrepresentation of facts; (2) That are likely to mislead or deceive because in context the statement makes only a partial disclosure of relevant facts; (3) That intend to or are likely to create false or unjustified expectations of favorable results; (4) Relating to fees, other than a standard consultation fee or a range of fees for specific types of services, without fully disclosing all relevant variables so that the statement would not be misunderstood or be deceptive to a layman; (5) Conveying the impression that the physician who has been registered by the Board to perform acupuncture could improperly influence a public body, official, corporation, or an individual on behalf of a patient; or (6) Containing representations that a physician who has been registered by the Board to perform acupuncture is: (a) Willing to perform any procedure which is illegal under the laws or regulations of Maryland or the United States, or (b) A licensed acupuncturist under Health Occupations Article, §1A-101 et seq., Annotated Code of Maryland, unless licensed by the State Acupuncture Board. C. A physician who has been registered by the Board to perform acupuncture is accountable under this regulation if the physician uses an agent, partnership, professional association, or health maintenance organization to implement actions prohibited by this regulation. ### Chapter 16 — Petition for Declaratory Ruling **Authority:** State Government Article, §§10-301 — 10-305, Annotated Code of Maryland **Administrative History:** Effective date: April 5, 1999 (26:7 Md. R. 543) #### Regulation .01 Definitions. *COMAR 10.32.16.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Physicians. (2) “Designee” means a person or committee to whom the Board has delegated responsibility for consideration of a petition. (3) “Person” means: (a) An individual; (b) An agency; (c) An association; (d) A corporation; or (e) Any other entity. #### Regulation .02 Petition. *COMAR 10.32.16.02* A. An interested person may file with the Board a petition for a declaratory ruling with respect to the manner in which the Board would apply: (1) A statute; (2) A regulation; or (3) An order which the Board enforces to a particular case based on the facts presented in the petition. B. The Board may delegate responsibility for consideration of the petition. The delegation may be limited to the: (1) Study of a request; and (2) Preparation of a proposed ruling for the Board's consideration. C. Petition for Declaratory Ruling. (1) The petition for a declaratory ruling shall be filed in writing on a form provided by the Board. (2) The petition shall contain a statement describing in detail: (a) The interest of the petitioner in making the request; (b) The issue involved; (c) A statement of the facts; and (d) A listing of documents or statements, or both, to be considered. (3) Unless this requirement is waived in writing by the Board, the petition shall contain a sworn statement by the petitioner that the facts contained in the petition are true to the best of the person's knowledge and belief. D. Granting of Petition. (1) Not later than 60 days from receipt of the petition, the Board shall inform the petitioner whether the petition will be granted. (2) If the petition is denied, the Board shall inform the petitioner in writing of the reasons for the denial. (3) If the petition is granted, the Board or the Board's designee shall inform the petitioner when to expect the declaratory ruling. #### Regulation .03 Consideration and Disposition. *COMAR 10.32.16.03* A. Consideration. (1) A petition will be granted whenever the Board or the Board's designee considers issuing a declaratory ruling advisable under the circumstances. (2) In rendering its ruling, the Board or the Board's designee: (a) Shall consider all materials submitted with the petition; (b) May consider any document, data, or other relevant material; (c) May consult individuals; (d) May consider comments from the staff; and (e) May require argument of the question or permit the introduction of evidence by the petitioner or, in the Board's sole discretion, by other persons. (3) Consideration of the proposed rulings prepared by the Board's designee shall be conducted according to procedures adopted by the Board in each case. B. Disposition. (1) A declaratory ruling issued shall be in writing, stating the: (a) Issue; (b) Conclusion; (c) Facts on which the conclusion was based; and (d) Sources relied upon. (2) A declaratory ruling issued by the Board shall plainly state that it is a declaratory ruling pursuant to this chapter. (3) A written answer from the Board or any employee or committee of the Board to an inquiry is not a declaratory ruling unless made in conformity with this chapter. C. Publication and Inspection. (1) The Board shall keep a record of each declaratory ruling issued and index all declaratory rulings issued by reference to the statute or regulation involved. (2) The Board may publish declaratory rulings of general interest subject to the mandates of State Government Article, Title 10, Subtitle 6, Part III, Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to that statute. D. Denial. A petition may be denied if the: (1) Request contains incomplete information on which to base an informed declaratory ruling; (2) Board or the Board's designee concludes that a declaratory ruling cannot reasonably be given on the matter; (3) Matter is adequately covered by a: (a) Regulation, (b) Declaratory ruling, (c) Decision, or (d) Legal opinion; (4) Matter is the subject of a pending disciplinary proceeding; or (5) The Board or the Board's designee concludes that a ruling would not be in the public interest. #### Regulation .04 Effect, Revision, and Appeal. *COMAR 10.32.16.04* A. Effect. A declaratory ruling shall be binding on the Board and the petitioner on the statement of facts covered in the declaratory ruling. B. Application for Revision. (1) The petitioner shall file an application for revision within 10 days after the issuance of the declaratory ruling. (2) The Board shall determine whether to reopen the declaratory ruling. (3) The Board may summarily deny an application for revision. (4) An application for revision does not stay the effect of the declaratory ruling. If the Board determines to grant the application and reopen the declaratory ruling, the declaratory ruling is stayed until the Board: (a) Issues a revised declaratory ruling; (b) Withdraws the declaratory ruling; or (c) Withdraws its determination to reopen. (5) A timely filed application for revision extends the time for judicial appeal of the declaratory ruling until the Board: (a) Denies the application; (b) Issues a revised declaratory ruling; (c) Withdraws the declaratory ruling; or (d) Withdraws its determination to reopen. (6) If the Board determines to reopen the declaratory ruling, the Board shall give the applicant notice of the determination and of any subsequent changes to the declaratory ruling. The determination to reopen a declaratory ruling does not confer any procedural rights on the applicant. (7) The Board shall deny applications for revision which contain additional or revised facts. The Board may treat the application as a request for a new declaratory ruling. (8) After determining to reopen a declaratory ruling, the Board may take any action which it is authorized to take with respect to original applications for declaratory rulings. (9) The Board's determination as to whether to reopen the declaratory ruling shall be made within 60 days of the application for revision. C. Revision on Board's Motion. (1) The Board may reopen a declaratory ruling on its own motion at any time 2 years or more after a declaratory ruling's issuance. (2) The declaratory ruling may be reopened if the Board determines that there have been subsequent changes in law, technology, economic or business conditions, or environment that render the declaratory ruling inaccurate or obsolete. (3) The Board shall give notice to the petitioner of the Board's decision to reopen a declaratory ruling. (4) Before a declaratory ruling is finally modified under this section, the Board shall give the petitioner the opportunity to submit written and oral argument to the Board. D. Appeal. A declaratory ruling is subject to review as provided in State Government Article, §10-305, Annotated Code of Maryland. ### Chapter 17 — Sexual Misconduct **Authority:** Health Occupations Article, §1-212, Annotated Code of Maryland **Administrative History:** Effective date: March 6, 2000 (27:4 Md. R. 454) **Administrative History:** Regulation .01 amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .02B amended effective May 20, 2019 (46:10 Md. R. 488) **Administrative History:** Regulation .03 amended effective May 20, 2019 (46:10 Md. R. 488) #### Regulation .01 Scope. *COMAR 10.32.17.01* This chapter prohibits sexual misconduct by health care practitioners. #### Regulation .02 Definitions. *COMAR 10.32.17.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Health care practitioner” means an individual licensed under Health Occupations Article, Titles 14 and 15, Annotated Code of Maryland. (2) Key Third Party. (a) “Key third party” means an individual who participates in the health and welfare of the patient concurrent with the physician-patient relationship. (b) “Key third party” includes, but is not limited to the following individuals: (i) Spouse; (ii) Partner; (iii) Family member; (iv) Guardian; (v) Surrogate; or (vi) Proxy designated by durable power of attorney. (3) Sexual Contact. (a) “Sexual contact” means the knowing touching directly or through clothing, where the circumstances surrounding the touching would be construed by a reasonable person to be motivated by the health care practitioner’s own prurient interest or for sexual arousal or gratification. (b) “Sexual contact” includes, but is not limited to: (i) Sexual intercourse, genital to genital contact; (ii) Oral to genital contact; (iii) Oral to anal contact or genital to anal contact; (iv) Kissing in a romantic or sexual manner; or (v) Nonclinical touching of breasts, genitals, or any other sexualized body part. (4) “Sexual harassment” means an unwelcome sexual advance, request for sexual favor, or other verbal or physical conduct of a sexual nature. #### Regulation .03 Sexual Misconduct. *COMAR 10.32.17.03* A. Health care practitioners may not engage in sexual misconduct. B. Health Occupations Article, §§14-404(a)(3), 14-5A-17(a)(3), 14-5B-14(a)(3), 14-5C-17(a)(3), 14-5D-14(a)(3), 14-5E-16(a)(3), 14-5F-18(a)(19), and 15-314(a)(3), Annotated Code of Maryland, includes, but is not limited to, sexual misconduct. C. Sexual misconduct includes, but is not limited to: (1) Engaging in sexual harassment of a patient, key third party, employee, student, or coworker regardless of whether the sexual harassment occurs inside or outside of a professional setting; (2) Failing to provide privacy for disrobing; (3) Performing a pelvic or rectal examination without the use of gloves; (4) Discussing the health care practitioner’s sexual problems, sexual likes or dislikes, or fantasies; (5) Using the health care practitioner-patient relationship to initiate or solicit a dating, romantic, or sexual relationship; (6) Engaging in a dating, romantic, or sexual relationship which violates §D of this regulation or the code of ethics of the American Medical Association, American Osteopathic Association, American Psychiatric Association, or other professional code of ethics; (7) Participating in any form of sexual contact with a patient or key third party; (8) Having nonconsensual sexual contact with a coworker or employee; (9) Causing a patient or key third party to touch the health care practitioner’s breasts, genitals, or any sexualized body part; (10) Encouraging a patient or key third party to masturbate in the presence of the health care practitioner or masturbation by the health care practitioner while a patient or key third party is present; (11) Offering to provide practice-related services in exchange for sexual favors; and (12) Exposing the health care practitioner’s breasts, genitals, or any sexualized body part. D. Sexual or Romantic Relationships. A health care practitioner may not engage in sexual behavior with: (1) A current patient; (2) A key third party if the key third party’s decisions directly affect the health and welfare of the patient or if the relationship could otherwise compromise the patient’s care based on the following considerations, which include, but are not limited to: (a) The nature of the patient’s medical problem and the likely effect on patient care; (b) The length of the professional relationship; (c) The degree of emotional dependence on the health care practitioner; (d) The importance of the clinical encounter to the key third party and the patient; and (e) Whether the health care practitioner-patient relationship can be terminated in keeping with ethics guidance and what implications doing so would have for the patient; and (3) A former patient upon consideration of the following factors: (a) Duration of the health care practitioner-patient relationship; (b) Nature of the health care services provided; (c) Lapse of time since the health care practitioner-patient relationship ended; (d) Extent to which the former patient confided personal or private information to the health care practitioner; (e) Degree of emotional dependence that the former patient has or had on the health care practitioner; (f) Extent to which the health care practitioner used or exploited the trust, knowledge, emotions, or influence derived from the previous health care practitioner-patient relationship; and (g) Whether the health care practitioner-patient relationship was terminated in order to enter into a romantic or sexual relationship. ### Chapter 18 — Compelling Purpose Disclosure **Authority:** Health Occupations Article, §§14-405 and 14-411; State Government Article, §10-617(h)(3); Annotated Code of Maryland **Administrative History:** Effective date: June 10, 2002 (29:11 Md. R. 889) #### Regulation .01 Disclosure for Compelling Public Purpose. *COMAR 10.32.18.01* A custodian of the Board may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns: A. Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority; B. A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation or over a facility in which the individual is practicing or has practiced and the information disclosed is limited to that information relevant to the possible violation by that individual; or C. Conduct by an individual which the Board reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual or regulates a facility in which the individual has practiced, or to a hospital or other health care facility where the individual has privileges. #### Regulation .02 Other Disclosures. *COMAR 10.32.18.02* This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information which the Board may otherwise disclose by law. ### Chapter 19 — Disclosure of Records to State Health Agencies **Authority:** Health-General Article, §18-102; Health Occupations Article, §14-411; Annotated Code of Maryland **Administrative History:** Effective date: March 3, 2014 (41:4 Md. R. 301) #### Regulation .01 Scope. *COMAR 10.32.19.01* This chapter does not alter the authority of the Secretary under of the Health Occupations Article, §1-203(a), Annotated Code of Maryland or Health-General Article, §2-106(c), Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.32.19.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland Board of Physicians. (2) “Department” means the Maryland Department of Health. (3) “Record” means the proceedings, records, or files of the Board. (4) “Secretary” means the Secretary of Health. #### Regulation .03 Disclosure of Information to the Department and Agencies Within the Department. *COMAR 10.32.19.03* A. The Board shall disclose information contained in a record to the Secretary upon receipt of a written request from the Secretary stating that the requested information is appropriate and needed for: (1) An investigation of quality or utilization of care in an entity regulated by the Office of Health Care Quality; (2) An investigation of quality or utilization of care in an entity regulated by the Health Services Cost Review Commission; or (3) An investigation regarding the introduction or spread of an infectious or contagious disease or other disease that endangers the public health in the State. B. The Board shall disclose information contained in a record to the Office of Health Care Quality upon receipt of a written request from the Director of the Office of Health Care Quality stating that the requested information is appropriate and needed for an investigation of quality or utilization of care in an entity regulated by the Office of Health Care Quality. C. The Board shall disclose information contained in a record to the Health Services Cost Review Commission upon receipt of a written request from the Executive Director of the Health Services Cost Review Commission stating that the requested information is appropriate and needed for an investigation of quality or utilization of care in an entity regulated by the Health Services Cost Review Commission. D. The Board shall disclose information contained in a record to the Maryland Health Care Commission upon receipt of a written request from the Executive Director of the Maryland Health Care Commission stating that the requested information is appropriate and needed in an investigation of quality or utilization of care in an entity regulated by the Maryland Health Care Commission. #### Regulation .04 Requirements Regarding the Transfer of a Record. *COMAR 10.32.19.04* A. The Board shall disclose the information required under this chapter as soon as reasonably possible, but no later than 30 days after a request made under this chapter. B. The information disclosed by the Board under this chapter shall be sent on paper by first-class mail or by another delivery method agreed to by the Board and the Secretary or agency requesting the information. #### Regulation .05 Confidentiality. *COMAR 10.32.19.05* Information disclosed by the Board under this chapter shall remain confidential and may not be redisclosed by the Secretary, the Office of Health Care Quality, the Health Services Cost Review Commission, or the Maryland Health Care Commission unless otherwise permitted by law. ### Chapter 20 — Licensure of Perfusionists **Authority:** Health Occupations Article, §§1-221, 1-606, 14-205, 14-5E-01 — 14-5E-20, and 14-5E-23, Annotated Code of Maryland **Administrative History:** Effective date: September 15, 2014 (41:18 Md. R. 1010) **Administrative History:** Regulation .02B amended effective January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .03 amended effective January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .03A amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .06 amended effective January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .08B amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .09A amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .09D, E adopted effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .10 amended effective August 15, 2016 (43:16 Md. R. 900); January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .11B amended effective January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .14 amended effective January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .15 amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .15B amended effective January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .16A amended effective January 19, 2026 (53:1 Md. R, 21) **Administrative History:** Regulation .17B, C amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .18 amended effective August 15, 2016 (43:16 Md. R. 900) **Administrative History:** Regulation .18A, C amended effective January 19, 2026 (53:1 Md. R, 21) #### Regulation .01 Scope. *COMAR 10.32.20.01* A. This chapter governs the practice of perfusion. B. Except as provided in §C or D of this regulation, on or after October 1, 2013, an individual shall be licensed by the Board before the individual may practice perfusion. C. This chapter does not prohibit any student who is currently enrolled in an accredited educational program to qualify for a license as a perfusionist from performing any of the procedures described in this chapter as part of that program’s clinical curriculum on perfusion. D. This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.32.20.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited educational program” means a program accredited by The Commission on Accreditation of Allied Health Education Programs (CAAHEP), or its successor accrediting agency. (2) “Board” means the State Board of Physicians. (3) “Certified clinical perfusionist” means an individual holding a certificate issued by the national certifying board. (4) “Certification” means recognition of an individual who has satisfied certain standards required by the national certifying board. (5) “Committee” means the Perfusion Advisory Committee established under Health Occupations Article, §14-5E-05, Annotated Code of Maryland. (6) “Conversion” means changing a license from licensed perfusionist-basic to licensed perfusionist-advanced. (7) “Disciplinary panel” means a panel established under Health Occupations Article, §14-401, Annotated Code of Maryland, which: (a) Is composed of 11 Board members; and (b) Addresses: (i) Complaints and disciplinary actions against licensed physicians and allied health professionals; (ii) Initial licensure decisions; and (iii) Postdisciplinary licensure reinstatements. (8) “Immediately available direction” means the responsibility of a licensed physician to provide necessary direction for a licensed perfusionist in person, by telephone, or by other electronic means. (9) “Joint Commission” means the organization formerly known as the Joint Commission on the Accreditation of Health Care Organizations. (10) “License” means a license issued by the Board to practice perfusion. (11) “Licensed perfusionist” means a perfusionist who is licensed by the Board, in accordance with Health Occupations Article, Title 14, Subtitle 5E, Annotated Code of Maryland, to practice perfusion as a: (a) Licensed perfusionist-advanced; or (b) Licensed perfusionist-basic. (12) “Licensed perfusionist-advanced” means an individual who is licensed by the Board as a perfusionist based on current certification as a certified clinical perfusionist. (13) “Licensed perfusionist-basic” means an individual who: (a) Is licensed by the Board as a perfusionist for a limited time based on graduation from an accredited perfusion educational program; and (b) Has not yet passed the national certifying examinations given by the national certifying board. (14) “Licensed physician” means a physician licensed by the Board. (15) “National Certifying Board” means the American Board of Cardiovascular Perfusion or its successor. (16) “National certifying examinations” means the two examinations given by the national certifying board. (17) “On-site direction” means the responsibility of a licensed physician to provide necessary direction for a licensed perfusionist when the physician is: (a) Physically present in the procedure room or in the facility; and (b) Able to respond if the perfusionist needs assistance during a procedure. (18) Practice Perfusion. (a) “Practice perfusion” means to perform the functions necessary for the support, treatment, measurement, or supplementation of the cardiovascular, circulatory, or respiratory systems, or other organs to ensure the safe management of physiologic functions by monitoring and analyzing the parameters of the systems under an order and the supervision of a licensed physician. (b) “Practice perfusion” includes: (i) Cardiopulmonary bypass for adult, pediatric, and neonatal patients; (ii) Extracorporeal circulatory support for renal, neurological, hepatic, and vascular surgery; (iii) Extracorporeal resuscitation; (iv) Extracorporeal circulation for long-term support of failing respiratory or cardiac function; (v) Extracorporeal membrane oxygenation; (vi) Extracorporeal carbon dioxide removal; (vii) Myocardial protection; (viii) Perfusion-assisted direct coronary artery bypass; (ix) Hemofiltration and hemodialysis; (x) Anticoagulation and hemostasis monitoring, analysis, and intervention; (xi) Thermal regulation; (xii) Blood gas and blood chemistry monitoring, analysis, and intervention; (xiii) Physiological monitoring, analysis, and intervention; (xiv) Administration of blood components and pharmaceuticals; (xv) Administration of anesthetic agents through a heart lung machine at the direction of an anesthesiologist; (xvi) Ventricular assist device and mechanical circulatory support management; (xvii) Intra-aortic balloon counterpulsation; (xviii) Temporary pacemaker management; (xix) Periodic flow augmentation therapy; (xx) Autotransfusion; (xxi) Platelet gel production, autologous hemocyte tissue matrix production; (xxii) Nondifferentiated progenitor cell harvest bone marrow aspirate concentration; (xxiii) Acute normovolemic hemodilution; (xxiv) Isolated limb or organ delivery of chemotherapeutics, progenitor cells, gene therapy vectors, and other items; (xxv) Organ procurement and preservation; (xxvi) Thermogenic lavage; (xxvii) Electrophysiological analysis; (xxviii) Therapeutic hyperthermia; (xxix) Intravascular membrane oxygenation; and (xxx) Renal perfusion. (19) “Student” means an individual who, in accordance with Health Occupations Article, §14-5E-09(c), Annotated Code of Maryland, is: (a) Enrolled in an accredited educational program to qualify for a license; and (b) Performing perfusion services within the accredited program under the supervision of a licensed perfusionist and without compensation. (20) “Supervision” means the responsibility of a licensed physician to exercise on-site direction or immediately available direction for a licensed perfusionist to ensure the safety and welfare of patients during the course of perfusion. #### Regulation .03 Perfusion Advisory Committee. *COMAR 10.32.20.03* A. The Board shall appoint members of the Committee as follows: (1) Three individuals who are licensed perfusionists-advanced and who: (a) Are certified by a National Certifying Board; and (b) Have a minimum of 2 years of perfusion experience. (2) Three physicians, at least one of whom: (a) Performs cardiac or cardio-thoracic surgery; or (b) Is a cardiac or cardio-thoracic anesthesiologist; and (3) One consumer member who: (a) Shall be a member of the general public; and (b) May not: (i) Practice, or ever have practiced perfusion, or any other health care profession; (ii) Be, or ever have been, in training to practice perfusion or any other health care profession; (iii) Have a household member who is a health care professional or is in training to be a health care professional; (iv) Participate, or ever have participated, in a commercial or professional field related to perfusion; (v) Have a household member who participates in a commercial or professional field related to perfusion; (vi) Have had, within 2 years before appointment, a financial interest in a person regulated by the Board; or (vii) Have had, within 2 years of appointment, a financial interest in the provision of goods or services to perfusionists or to the field of perfusion. B. Chair. (1) The Committee shall elect a chair from among its members. (2) The chair shall serve for 2 years. C. Tenure. (1) The term of a member is 3 years. (2) The terms of the members are staggered. (3) At the end of a term, a member continues to serve until a successor is appointed and qualifies. (4) An individual may be reappointed for a second 3-year term, but the individual may not serve more than two consecutive 3-year terms. (5) The terms of the initial members of the Perfusion Advisory Committee shall expire as follows: (a) Two members in 2013; (b) Two members in 2014; and (c) Three members in 2015. D. Vacancy. (1) If a vacancy occurs, the Board shall appoint a new member to serve. (2) The successor member shall only serve for the remainder of the term, unless reappointed. E. Quorum. (1) A majority of the members then serving on the Committee is a quorum. (2) Business may not be conducted at a Committee meeting unless there is a quorum. F. The Committee shall develop and make recommendations to the Board in any matter related to regulating the practice of perfusion in the State. G. The Board shall: (1) Consider all recommendations of the Committee; and (2) Provide the Committee with an annual report on disciplinary matters involving licensees. #### Regulation .04 Code of Ethics. *COMAR 10.32.20.04* A. The ethical responsibilities of a licensed perfusionist include, but are not limited to, compliance with the principles set forth in §B of this regulation. B. A licensed perfusionist: (1) Shall: (a) Practice medically acceptable methods of treatment and may not endeavor to practice beyond the competence and the authority vested in the perfusionist by the physician; (b) Report: (i) Known illegal, unethical, or incompetent conduct; or (ii) In good faith, suspected illegal, unethical, or incompetent conduct; (c) Respect the patient’s rights and dignity; (d) Maintain patient confidentiality and protect privileged information; (e) Place the patient’s best interest ahead of all else; (f) Guard against conflicts of interest including avoiding those involving financial or personal gain; (g) Uphold the dignity and honor of the profession and abide by its ethical principles; and (h) Be familiar with existing state and federal laws governing the practice of perfusion and comply with those laws; and (2) May not: (a) Delegate any perfusion duty to an individual not having the appropriate training and skill to undertake such responsibility; (b) Falsify documentation on patient records; and (c) Falsify reports submitted to the Board. C. All services shall be provided with respect for the dignity of the patient, unrestricted by considerations of: (1) Social or economic status; (2) Personal attributes; or (3) The nature of health problems. D. A breach of ethical principles may be considered immoral or unprofessional conduct in the practice of perfusion. #### Regulation .05 Standards of Care. *COMAR 10.32.20.05* A. In evaluating the standards of care for the practice of a licensed perfusionist, the Board may consider, but is not limited to, the guidelines published by the American Society of Extracorporeal Technology (AmSECT). B. If a particular practice issue has not yet been addressed in the AmSECT guidelines, the Board may consult with a licensed perfusionist-advanced. #### Regulation .06 Qualifications for Licensure as a Perfusionist. *COMAR 10.32.20.06* A. The Board shall license an individual if the individual meets the requirements of §§B and C of this regulation. B. An individual applying for a license shall: (1) Complete an application on a form supplied by the Board; (2) Pay the required application fee set by the Board in Regulation .13 of this chapter; (3) Be 18 years old or older; (4) Be of good moral character; (5) Demonstrate spoken and written competency in English by any of the following: (a) Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Documentation of graduation from a recognized English-speaking professional school; or (c) Documentation of receiving a grade of at least: (i) 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) 79 on the total score of the Internet-based Test of English as a Foreign Language; (6) If applicable, provide documentation of licensure, certification, or registration from all states and jurisdictions where the applicant has ever held a license, certificate, or registration in any health profession; (7) Have no history of public disciplinary action taken, or pending, against any license currently or previously held or expired; and (8) Complete a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland. C. An applicant for a license as: (1) A perfusionist-basic shall submit satisfactory evidence of graduation from a perfusion educational program that is accredited by the Commission on Accreditation of the Allied Health Education Program, or the Commission’s predecessor or successor; (2) A perfusionist-advanced shall submit satisfactory evidence of current national certification from the National Certifying Board. #### Regulation .07 Scope of Practice. *COMAR 10.32.20.07* A. A licensed perfusionist may practice only under the supervision of a licensed physician. B. The scope of practice of a licensed perfusionist is performance of the functions necessary for the support, treatment, measurement, or supplementation of the cardiovascular, circulatory, or respiratory systems, or other organs to ensure the safe management of physiologic functions by monitoring and analyzing the parameters of the systems. C. The scope of practice of a licensed perfusionist includes the following special procedures, performed on the order of and under the supervision of a licensed physician: (1) Cardiopulmonary bypass for adult, pediatric, and neonatal patients; (2) Extracorporeal circulatory support for renal, neurological, hepatic, and vascular surgery; (3) Extracorporeal resuscitation; (4) Extracorporeal circulation for long-term support of failing respiratory or cardiac function; (5) Extracorporeal membrane oxygenation; (6) Extracorporeal carbon dioxide removal; (7) Myocardial protection; (8) Perfusion-assisted direct coronary artery bypass; (9) Hemofiltration and hemodialysis; (10) Anticoagulation and hemostasis monitoring, analysis, and intervention; (11) Thermal regulation; (12) Blood gas and blood chemistry monitoring, analysis, and intervention; (13) Physiological monitoring, analysis, and intervention; (14) Administration of blood components and pharmaceuticals; (15) Administration of anesthetic agents through a heart lung machine at the direction of an anesthesiologist; (16) Ventricular assist device and mechanical circulatory support management; (17) Intra-aortic balloon counterpulsation; (18) Temporary pacemaker management; (19) Periodic flow augmentation therapy; (20) Autotransfusion; (21) Platelet gel production, autologous hemocyte tissue matrix production; (22) Nondifferentiated progenitor cell harvest bone marrow aspirate concentration; (23) Acute normovolemic hemodilution; (24) Isolated limb or organ delivery of chemotherapeutics, progenitor cells, gene therapy vectors, and other items; (25) Organ procurement and preservation; (26) Thermogenic lavage; (27) Electrophysiological analysis; (28) Therapeutic hyperthermia; (29) Intravascular membrane oxygenation; and (30) Renal perfusion. #### Regulation .08 Identification; Notice. *COMAR 10.32.20.08* A. A licensed perfusionist shall wear an identification tag or a badge which identifies that individual as a licensed perfusionist. B. License. (1) A licensed perfusionist shall: (a) Keep a copy of the licensee’s license in their employment file; and (b) Make the license available for inspection upon request. (2) If the perfusionist has multiple places of employment, copies of the license may be kept in accordance with §B(1) of this regulation. C. Change of Name or Address. (1) A licensed perfusionist shall notify the Board in writing of any changes in name or mailing address within 60 days. (2) The Board may impose a fine of $100 for failure to notify the Board of a change in name or mailing address. #### Regulation .09 Terms of Perfusionist-Basic License. *COMAR 10.32.20.09* A. Term and Expiration. (1) A perfusionist-basic license shall expire 2 years after it is issued. (2) Except as provided in §§D and E of this regulation, a perfusionist-basic license may not be renewed or extended beyond the 2-year expiration date. (3) An individual who previously held a perfusionist-basic license may not be granted a new perfusionist-basic license. (4) Upon expiration of the perfusionist-basic license, an individual who does not meet the requirements for a perfusionist-advanced license is ineligible for licensure and may not practice perfusion in this State. B. Conversion. (1) The holder of a perfusionist-basic license shall convert the license to a perfusionist-advanced license at any time before the expiration after meeting the requirements outlined in Regulation .06B(2) of this chapter. (2) The individual shall ensure that the national certifying board submits evidence, satisfactory to the Board, that the individual meets the requirements of Regulation .06B(2) of this chapter. (3) If the Board receives the notification specified in §B(2) of this regulation, the Board shall issue a perfusionist-advanced license to the individual at no additional charge. (4) If the holder of the perfusionist-basic license fails to convert the license to a perfusionist-advanced license before the expiration date, the individual shall file a new application for a perfusionist-advanced license. C. Conversion-or-Expiration Notice. At least 1 month before the expiration of the perfusionist-basic license, the Board shall send notice to the licensed perfusionist-basic that states: (1) The date on which the current perfusionist-basic license expires; (2) The date by which notification of meeting requirements outlined in Regulation .06B(2) shall be received in order to convert to a perfusionist-advanced license before the perfusionist-basic license expires; and (3) Notice that upon expiration of the perfusionist-basic license, if the holder does not qualify for a perfusionist-advanced license, the holder is no longer permitted to practice perfusion in this State. D. The Board may permit a perfusionist with a basic license to continue to practice on that license if extenuating circumstances prevented the applicant for an advanced license from taking the national certifying examination given by the American Board of Cardiovascular Perfusion. The applicant shall specify the: (1) Extenuating circumstances; and (2) Basis for granting the request. E. Petition for Extension. (1) At the discretion of the Board, a petition for extension of a perfusionist-basic license expiration date may be considered if: (a) The licensee: (i) Incurs a hardship that prevents the licensee from active use of the perfusionist-basic license for a period of at least 45 consecutive calendar days; (ii) Provides a written request, with supporting documentation if applicable, stating the extenuating circumstances that will prohibit or has prohibited the licensee from active use of the perfusionist-basic license for at least 45 consecutive calendar days; and (iii) Provides an anticipated date for resuming activity on the perfusionist-basic license; and (b) The national certifying examination has been administered during no more than three testing windows from the time the application for the perfusionist basic license was approved. (2) A perfusionist with a basic license may not practice during the paused time frame. Practicing or attempting to practice without an active license is in violation of Regulation .15 of this chapter and is punishable under that regulation. (3) The Board may grant a one-time extension of the perfusionist-basic license expiration date but the extension may not exceed the time period that the perfusionist with the basic license did not have active use of the license. (4) The Board may grant an extension if the Board determines that failure to fulfill the license requirements is clearly the result of: (a) Functional impairment; (b) Prolonged and serious illness; (c) Mandatory military service or deployment; (d) A prolonged absence from the United States; (e) An officially declared disaster; or (f) Other exceptional circumstances beyond the control of the applicant. (5) Failing the national certification examination is not grounds for obtaining an extension. #### Regulation .10 Renewal and Reinstatement of Licensure as a Perfusionist-Advanced. *COMAR 10.32.20.10* A. Renewal Notice. At least 1 month before the license expires, the Board shall send a renewal notice to the licensed perfusionist-advanced that states: (1) The date on which the current license expires; (2) The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the license expires; and (3) The amount of the renewal fee set by the Board in Regulation .13 of this chapter. B. Renewal. (1) The term of a license issued by the Board may not exceed 3 years. (2) The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. (3) An individual licensed as a perfusionist-basic may not renew the license. (4) An individual who has been licensed by the Board as a perfusionist-advanced may renew the license every 2 years on or before the date specified by the Board by: (a) Submitting a renewal application online or on a form supplied by the Board; (b) Paying the required renewal fee set by the Board in Regulation .13 of this chapter; (c) Attesting to current certification by the National Certifying Board; and (d) Being of good moral character. C. Reinstatement. The Board shall reinstate the license of a perfusionist-advanced who has failed to renew the license for any reason if the perfusionist-advanced: (1) Completes a reinstatement application on a form supplied by the Board; (2) Meets any additional requirements set by the Board for reinstatement of a license; (3) Pays the required reinstatement fee and any other applicable fees set by the Board; (4) Is of good moral character; and (5) Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland. D. Reinstatement of a Revoked License. (1) On the application of an individual whose license has been revoked, the Board, on the affirmative vote of a majority of the quorum, may in its discretion reinstate a revoked license. (2) When a time period is not stated in an order for revocation: (a) The Board may not entertain an application for post-disciplinary reinstatement until at least 3 years after the date of the order; and (b) A revocation of a license may not be for less than 1 year. (3) The Board may not entertain an application for post-disciplinary reinstatement after an order of revocation unless: (a) Any time period stated in the order has expired; (b) Any condition set out in the order has been fulfilled; (c) The applicant has filed a formal application and paid the fee set by the Board in Regulation .13 of this chapter; and (d) The applicant meets all of the requirements for reinstatement set out in §D of this regulation. (4) The Board shall entertain applications for reinstatement pursuant to the procedures and standards of COMAR 10.32.02.06B. (5) The Board may not entertain applications for reinstatement if a revocation is permanent. #### Regulation .11 Continuing Education. *COMAR 10.32.20.11* A. Application. (1) The continuing education requirements apply to all renewal applications. (2) The Board may not renew or reinstate the license of a perfusionist-advanced unless the perfusionist-advanced has met the requirements for continuing education described in §B of this regulation. B. Requirements. A licensed perfusionist-advanced shall meet continuing education requirements sufficient to maintain current national certification from the National Certifying Board. C. Documentation of Continuing Education Credits. A current certificate from the national certifying board will serve as documentation of continuing education credits earned. #### Regulation .12 Clinical Activity. *COMAR 10.32.20.12* A. Application. (1) The clinical activity requirements apply to all renewal applications. (2) The Board may not renew or reinstate the license of a perfusionist-advanced unless the perfusionist-advanced has met the requirements for clinical activity described in §B of this regulation. B. Requirements. A licensed perfusionist-advanced shall meet clinical activity requirements sufficient to maintain current national certification from the national certifying board. C. Documentation of Clinical Activity. A current certificate from the national certifying board will serve as documentation of clinical activities performed. #### Regulation .13 Fees. *COMAR 10.32.20.13* The following non-refundable fees are applicable to perfusionists: A. Perfusionist initial license application fee: (1) Before October 1, 2015 — $300; and (2) After October 1, 2015 — To be determined and promulgated in regulations by the Board in accordance with Health Occupations Article, §14-205(a)(16), Annotated Code of Maryland (Supp. 2013); B. Perfusionist license renewal fees, after October 1, 2015: (1) License renewal fee — To be determined and promulgated in regulations by the Board in accordance with Health Occupations Article, §14-205(a)(16), Annotated Code of Maryland (Supp. 2013); (2) Maryland Health Care Commission (MHCC) fee — As determined by MHCC under COMAR 10.25.03; C. Reinstatement fee, after October 1, 2015 — To be determined and promulgated in regulations by the Board in accordance with Health Occupations Article, §14-205(a)(16), Annotated Code of Maryland (Supp. 2013); D. Written verification of licensure fee — $25; and E. Replacement of license fee — $25 #### Regulation .14 Prohibited Conduct. *COMAR 10.32.20.14* A. Subject to the hearing provision of Health Occupations Article, §14-405, Annotated Code of Maryland, the disciplinary panel may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee: (1) Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or licensee or for another; (2) Fraudulently or deceptively uses a license; (3) Is guilty of unprofessional or immoral conduct in the practice of perfusion; (4) Is professionally, physically, or mentally incompetent; (5) Abandons a patient; (6) Is habitually intoxicated; (7) Is addicted to, or habitually abuses, any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; (8) Provides professional services while: (a) Under the influence of alcohol; or (b) Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts or without valid medical indication; (9) Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain; (10) Willfully makes or files a false report or record in the practice of perfusion; (11) Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report; (12) Breaches patient confidentiality; (13) Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient; (14) Knowingly makes a misrepresentation while practicing perfusion; (15) Knowingly practices perfusion with an unauthorized individual or aids an unauthorized individual in the practice of perfusion; (16) Knowingly delegates a perfusion duty to an unlicensed individual; (17) Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment or medicine; (18) Is disciplined by a licensing or disciplinary authority or is convicted or disciplined by a court of any state or country or is disciplined by any branch of the United States uniformed services or the US Department of Veterans Affairs for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes; (19) Fails to meet appropriate standards for the delivery of perfusion services; (20) Knowingly submits false statements to collect fees for which services are not provided; (21) Has been subject to investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes; and has: (a) Surrendered the license, if any, issued by the state or country; or (b) Allowed the license, if any, issued by the state or country to expire or lapse; (22) Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (23) Sells, prescribes, gives away, or administers drugs for illegal or illegitimate medical purposes; (24) Practices or attempts to practice beyond the authorized scope of practice; (25) Is convicted of or pleads nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; (26) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; (27) Practices or attempts to practice a perfusion procedure or uses or attempts to use perfusion equipment if the applicant or licensee has not received education and training in the performance of the procedure or the use of the equipment; or (28) Fails to cooperate with a lawful investigation of the Board. (29) Fails to complete a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland. B. Crimes of Moral Turpitude. (1) On the filing of certified docket entries with the Board by the Office of the Attorney General, the disciplinary panel shall order the suspension of a license if the licensee is convicted of, or pleads guilty or nolo contendere with respect to, a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. (2) After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the disciplinary panel shall order the revocation of a license on the certification by the Office of the Attorney General. C. Unless the disciplinary panel agrees to accept the surrender of a license, a licensed perfusionist may not surrender the license nor may the license lapse by operation of law while the licensee is under investigation or while charges are pending against the licensee. #### Regulation .15 Penalties. *COMAR 10.32.20.15* A. Except as otherwise provided in Health Occupations Article, §14-5E-01(g), Annotated Code of Maryland, an individual may not practice, attempt to practice, or offer to practice perfusion in this State unless licensed to practice perfusion by the Board. B. An individual who violates any provision of this chapter is subject to a civil fine of not more than $5,000 to be levied by the disciplinary panel. C. The Board shall pay any penalty collected under this regulation into the Board of Physicians Fund. #### Regulation .16 Investigations, Hearings, and Appeals. *COMAR 10.32.20.16* A. A. Complaints alleging prohibited conduct shall be referred to the disciplinary panel to be investigated according to the disciplinary panel’s procedures. B. A hearing on charges issued under Regulation .14 of this chapter or Health Occupations Article, §14-5E-16(a), Annotated Code of Maryland, shall be held in accordance with the hearing provisions of Health Occupations Article, §14-405, Annotated Code of Maryland. C. Proceedings for crimes of moral turpitude under Health Occupations Article, §14-5E-16 (c), Annotated Code of Maryland, or Regulation .14B of this chapter, shall be held in accordance with COMAR 10.32.02.08. D. Appeals from a final Board decision shall be taken in accordance with Health Occupations Article, §14-5E-17, Annotated Code of Maryland. #### Regulation .17 Required Reports. *COMAR 10.32.20.17* A. Except as provided in §B, C, or F of this regulation, hospitals, related institutions, alternative health systems as defined in Health Occupations Article, §1-401, Annotated Code of Maryland, and employers shall file with the Board a report that the hospital, related institution, alternative health system, or employer limited, reduced, otherwise changed, or terminated any licensed perfusionist for any reason that might be grounds for disciplinary action under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, or any regulation in this chapter. B. If the action taken by a hospital, related institution, alternative health system, or employer under §A of this regulation relates to alcohol or drug impairment, the hospital, related institution, alternative health system or employer is not required to report the perfusionist to the Board if: (1) The hospital, related institution, alternative health system, or employer knows that the licensed perfusionist is: (a) In an alcohol or drug treatment program that is: (i) Accredited by The Joint Commission or its successor; or (ii) Certified by the Maryland Department of Health; or (b) Under the care of a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse; (2) The perfusionist takes appropriate steps to permit the hospital, related institution, alternative health system, or employer to verify that the licensed perfusionist remains in the treatment program and is compliant with the requirements of that program until discharge; and (3) The action of condition of the licensed perfusionist has not caused injury to an individual while the perfusionist is practicing as a licensed perfusionist. C. If a licensed perfusionist enters or is considering entering an alcohol or drug treatment program that is accredited by The Joint Commission or its successor that is certified by the Maryland Department of Health, the licensed perfusionist shall notify the hospital, related institution, alternative health system, or employer of the licensed perfusionist’s decision to enter the treatment program. D. If the licensed perfusionist fails to provide the notice required under §C of this regulation, and the hospital, related institution, alternative health system, or employer learns that the licensed perfusionist has entered a treatment program, the hospital related institution, alternative health system, or employer shall report to the Board that the licensed perfusionist has: (1) Entered a treatment program; and (2) Failed to provide the required notice. E. If the perfusionist has failed to take appropriate steps or has failed to remain compliant under §B(2) of this regulation or has failed to provide the required notice under §C of this regulation, the perfusionist may not use his or her participation in the treatment program as a mitigating circumstance in any disciplinary action. F. Noncompliance. (1) If the licensed perfusionist is found to be noncompliant with the treatment program’s policies and procedures while in the treatment program, the treatment program shall notify the hospital, related institution, alternative health system, or employer of the licensed perfusionist’s noncompliance. (2) On receipt of the notification required under §C of this regulation, the hospital, related institution, alternative health system, or employer of the licensed perfusionist shall report the licensed perfusionist’s noncompliance to the Board. G. A person as defined in Health Occupations Article, §14-101(h), Annotated Code of Maryland, is not required under this regulation to make any report that would be in violation of any federal or state law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records. H. The hospital, related institution, alternative health system, or employer shall submit a required report within 10 days of any action described in this regulation. I. A report made under this regulation is not subject to subpoena or discovery in a civil action other than a proceeding arising out of a hearing and decision of the Board under Health Occupations Article, Title 14, Annotated Code of Maryland. #### Regulation .18 Fines, Penalties, and Sanctioning. *COMAR 10.32.20.18* A. General Application of Sanctioning Guidelines. (1) Sections A and B of this regulation and Regulation .19 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §B of this regulation, for violations of Health Occupations Article §14-5E-16 Annotated Code of Maryland, listed in the sanctioning guidelines, the disciplinary panel shall impose a sanction not less severe than the minimum listed in the sanctioning guidelines nor more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation. (c) A stayed suspension not meeting the criteria for §A(3)(b) of this regulation is ranked as a reprimand. (d) A fine listed in the sanctioning guidelines may be imposed in addition to, but not as a substitute for a sanction. If a fine is listed, then at least the minimum fine will be imposed in addition to the sanction. (e) The imposition of a fine does not affect the making of the sanction. (4) The disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the chart. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking should be used to determine which ground will be used in developing a sanction; and (b) The Board may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .19 of this chapter, in order to resolve a pending disciplinary action, the Board and the licensee may agree to a surrender of license or a consent order with terms and sanction agreed to by the Board, the administrative prosecutor, and the licensee. B. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, the Board may consider the aggravating and mitigating factors set out in §B(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. (3) The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (4) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the Board and was cooperative during the Board proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (5) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. C. Offenses Related to Continuing Education Credits. (1) Willful Falsification. (a) If a licensee has willfully falsified an application with respect to continuing education credits, the licensee may be charged under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5E-16(a)(1), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5E-16(a)(3), Annotated Code of Maryland; (iii) Health Occupations Article, §14-5E-16(a)(10), Annotated Code of Maryland; and (iv) Health Occupations Article, §14-5E-16(a)(11), Annotated Code of Maryland. (b) Upon finding a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines. (2) Licensees Previously Disciplined Under §C(1) of this regulation. (a) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines for a subsequent offense. (b) The Board may not apply the sanction described in §C(1) of this regulation in determining a sanction for a licensee previously disciplined for an offense related to continuing education credits. D. Offenses Related to Clinical Activity. (1) Willful Falsification. (a) If a licensee has willfully falsified an application with respect to clinical activities, the licensee may be charged under one or more of the following, as appropriate: (i) Health Occupations Article, §14-5E-16(a)(1), Annotated Code of Maryland; (ii) Health Occupations Article, §14-5E-16(a)(3), Annotated Code of Maryland; (iii) Health Occupations Article, §14-5E-16(a)(10), Annotated Code of Maryland; and (iv) Health Occupations Article, §14-5E-16(a)(11), Annotated Code of Maryland. (b) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines. (2) Licensees Previously Disciplined Under §D(1) of this regulation. (a) Upon a finding of a violation, the Board may impose any discipline authorized under Health Occupations Article, §14-5E-16, Annotated Code of Maryland, and the sanctioning guidelines. (b) The Board may not apply the sanction described in §D(1) of this regulation in determining as sanction for a licensee previously fined or disciplined for an offense related to criminal activities. #### Regulation .19 Sanctioning Guidelines for Perfusionists. *COMAR 10.32.20.19* A. Subject to provisions of Regulation .18A and B of this chapter, the Board may impose sanctions as outlined in §B of this regulation on perfusionists for violations of Health Occupations Article, §14-5E-16, Annotated Code of Maryland, or Regulation .14 of this chapter. B. Range of Sanctions. ### Chapter 21 — Licensure, Regulation, and Discipline of Naturopathic Doctors **Authority:** Health Occupations Article, §§14-5F-12.1—14-5F-32, Annotated Code of Maryland **Administrative History:** Effective date: September 12, 2016 (43:18 Md. R. 1017) **Administrative History:** Regulation .02B amended effective August 28, 2017 (44:17 Md. R. 835); January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .03-1 adopted effective January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .03-2 adopted effective January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .04C, D amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .05A, B amended effective January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .05D, E adopted effective January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .06B, C amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .10 repealed and new Regulation .10 adopted effective August 28, 2017 (44:17 Md. R. 835); January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .11A amended effective August 28, 2017 (44:17 Md. R. 835) **Administrative History:** Regulation .11B amended effective January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .20 amended effective January 19, 2026 (53:1 Md. R. 22) **Administrative History:** Regulation .21 adopted effective August 28, 2017 (44:17 Md. R. 835) #### Regulation .01 Scope. *COMAR 10.32.21.01* This chapter governs how an individual becomes licensed as a naturopathic doctor and how naturopathic doctors are regulated and disciplined. #### Regulation .02 Definitions. *COMAR 10.32.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Approved naturopathic medical program” means a naturopathic medical education program: (a) In the United States that: (i) Provides the degree of Doctor of Naturopathy or Doctor of Naturopathic Medicine; (ii) Offers a 4-year graduate level full-time didactic and supervised clinical training; (iii) Is accredited or has achieved candidacy status for accreditation, by the council on naturopathic medial education or an equivalent federally and Board recognized accrediting body for naturopathic medical education programs; and (iv) Is part of an institution of higher education that is either accredited, or is a candidate for accreditation, by a regional or national institutional accrediting agency recognized by the United States Secretary of Education; (b) In a diploma-granting, degree-equivalent college or university in Canada that: (i) Offers graduate level, full-time didactic and supervised clinical training; and (ii) Is accredited, or has achieved candidacy status for accreditation, by the council of naturopathic medical education or an equivalent federally and Board recognized accrediting body for participation in government-funded student aid programs; or (c) Has provincial approval for participation in government-funded student aid programs. (2) “Articular manipulation” means manipulation of the joints up to but not including manipulation beyond the elastic limit and exclusive of low amplitude, high velocity thrusts, also known as Grade V manipulations. (3) “Attestation” means a statement of intent. (4) “Board” means the State Board of Physicians. (5) “Central Repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services. (6) “Collaborate” means a cooperative relationship between naturopathic doctors and licensed physicians, which does not imply or create a supervisory relationship between the licensed physician and the naturopathic doctor. (7) “Collaboration and consultation agreement” means an agreement whereby a naturopathic doctor and physician will collaborate and consult regarding a patient’s care, but in which the: (a) Patient does not enter the care of the consulted physician; (b) Consultation does not create a physician-patient relationship; and (c) Consulted physician does not direct patient care or engage directly in the care of the patient. (8) “Committee” means the Naturopathic Medicine Advisory Committee. (9) “Consult” or “consultation” means a process whereby a naturopathic doctor seeks the advice or opinion of a licensed or certified health care provider as needed in the treatment of a patient, which may include discussion of the: (a) Patient’s diagnosis; (b) Differential diagnoses and diagnostic method; (c) Current naturopathic treatment; (d) Patient’s response thus far to naturopathic treatment; (e) Potential medical and other options outside the naturopathic doctors scope of practice that might benefit the patient; (f) Patient’s potential response to diagnostic and treatment options outside the naturopathic doctor’s scope of practice; and (g) Patient’s expected prognosis. (10) “Corrective and orthopedic gymnastics” means therapeutic exercises, stretching, and other movement therapies intended to promote healing and rehabilitation. (11) “Council” means the Naturopathic Doctors Formulary Council. (12) “Criminal history records check” means the performance of both a State criminal history check by the Central Repository, and a national criminal history check by the Federal Bureau of Investigation. (13) “Criminal history records information” means information provided by the criminal history records check regarding an applicant’s criminal arrests, charges, and convictions, and the disposition of pending criminal charges. (14) “Diagnostic imaging” includes, but is not limited to, X-ray, ultrasound, mammogram, bone densitometry, computed tomography (CT scans), magnetic resonance imaging (MRI scans), endoscopic exam, and all other forms of nuclear imaging. (15) “Electromagnetic energy” means electric and magnetic energy administered through the use of a therapeutic device, including, but not limited to, transcutaneous electrical nerve stimulation, microcurrent electrical muscle stimulation, diathermy, infrared, ultra-violet treatments, and other devices which utilize electrical or magnetic force for therapeutic effect. (16) “Electrotherapy” means treatment through application of electric energy administered through the use of therapeutic devices, including, but not limited to, transcutaneous electrical nerve stimulation, microcurrent electrical neuromuscular stimulation, and other devices which utilize electrical force for therapeutic effect. (17) Goods. (a) “Goods” means items that can be sold. (b) “Goods” includes, but is not limited to, natural medicines referenced in Health Occupations Article, §14-5F—14(a)(3) and (4), Annotated Code of Maryland. (18) Hydrotherapy. (a) “Hydrotherapy” means external and internal applications of hot and cold water, ice, and steam for therapeutic purposes. (b) “Hydrotherapy” includes, but is not limited to, hot or cold compresses, hydrocollator packs, hot or cold baths or showers involving the full body or specific body parts. (19) “Licensed naturopathic doctor” means a naturopathic doctor who is licensed by the Board to practice naturopathic medicine. (20) “Mechanical sciences of healing” means techniques and therapies which attempt to promote healing via mechanical or physical applications. (21) “Mechanotherapy” means treatment by mechanical means including the use of durable medical and therapeutic devices. (22) “Natural medicine” means medicine derived from mineral, animal, or botanical origin. (23) “Naturopathic doctor” means an individual who practices naturopathic medicine. (24) Naturopathic Medicine. (a) “Naturopathic medicine” means the prevention, diagnosis, and treatment of human health conditions, injury, and disease using only patient education and naturopathic therapies and their therapeutic substances recognized by the council of naturopathic therapies and therapeutic substances recognized by the Council of Naturopathic Medical Education. (b) “Naturopathic medicine” includes: (i) Counseling; (ii) The practice of the mechanical sciences of healing, including mechanotherapy, articular manipulations, corrective and orthopedic gymnastics, hydrotherapy, electrotherapy, and phototherapy; and (iii) The practice of the material sciences of healing, including nutrition, phytotherapy, treatment by natural substances, and external applications. (25) “Naturopathic musculoskeletal mobilization” means the treatment by manual and other mechanical means of all body tissues exclusive of high-velocity thrusts at or beyond the end range of normal joint motion. (26) “Non-bona-fide treatment” means when: (a) A naturopathic doctor treats or examines a patient in a way that involves sexual contact when there is no medical reason for the procedure; or (b) The procedure falls outside a naturopathic doctor’s scope of practice. (27) “Phototherapy” means treatment through application of light, including visible light, ultraviolet light, infrared, natural sources of light, and artificial sources of light. (28) Physiological Function Tests. (a) “Physiological function tests” means all tests performed to assess and diagnose physiological processes in all bodily systems. (b) “Physiological function tests” include, but are not limited to, respiratory testing, heart rate, percent body fat, body composition, and others, as consistent with naturopathic medical education. (29) “Phytotherapy” means treatment by use of botanical medicines. (30) “Prescription drug” means any drug defined in the federal Food, Drug, and Cosmetic Act, 21 U.S.C. §503(b), as amended, if the drug’s label is required to bear the statement “Rx only”. (31) “Sexually exploitative relationship” means a naturopathic doctor taking advantage of an unequal relationship between the naturopathic doctor and patient, staff member, or student. (32) “Therapeutic deception” means representation by a naturopathic doctor that sexual contact or sexual activity by or with a patient is consistent with or part of a patient’s treatment. #### Regulation .03 Naturopathic Medicine Advisory Committee. *COMAR 10.32.21.03* A. The Committee shall consist of five members appointed by the Board as follows: (1) Two members shall be individuals who: (a) Practice naturopathic medicine; (b) Are certified by the North American Board of Naturopathic Examiners; (c) Have a minimum of 2 years’ experience in naturopathic medicine; and (d) By March 1, 2016 or thereafter, are licensed as a naturopathic doctor; (2) One member: (a) Shall be a consumer member; (b) Shall be a resident of Maryland; (c) May not be or ever have been licensed to practice a health occupation in Maryland; and (d) May not have a substantial personal, business, professional, or pecuniary connection with naturopathic education, business, or practice; (3) One member shall be a practicing: (a) Licensed physician; or (b) Doctor of osteopathy who is a member of the Board; and (4) One member shall be a practicing licensed physician or practicing licensed doctor of osteopathy with experience working with naturopathic doctors by having met one or more of the following criteria: (a) Worked in the same clinical practice as a licensed naturopathic doctor; (b) Named in an attestation submitted by a licensed naturopathic doctor; (c) Employed by a naturopathic medicine program accredited by the Council on Naturopathic Medical Education; (d) Worked with, or supervised, a naturopathic resident completing a naturopathic medical residency accredited by the Council on Naturopathic Medical Education; (e) Graduated from a naturopathic medical program accredited by the Council on Naturopathic Medical Education and holding a naturopathic doctor or naturopathic physician license in any state that licenses Naturopathic Doctors or Naturopathic Medical Doctors in addition to holding a medical doctorate or doctor of osteopathy physician’s license; (f) Was a Diplomate of the American Board of Integrative Medicine, a graduate of any fellowship program in Integrative Medicine approved by the American Board of Integrative Medicine, a graduate of any fellowship program in Integrative Medicine approved by the American Board of Medical Specialties, or a diplomate of the American Board of Integrative Holistic Medicine; or (g) Accrued at least 20 Category 1 continuing medical education credits, in the 2 years before serving, in topics of natural, nutritional, holistic or integrative medicine delivered by a professional association whose primary mission is the advancement of one of these fields. B. The Committee shall: (1) On request, review selected applications for licensure or reinstatement of naturopathic doctors and make recommendations to the Board as to what action to take on the applications; (2) Review each written attestation; (3) Make recommendations to the Board regarding regulations governing naturopathic doctors; (4) Advise the Board on matters related to the practice of naturopathic medicine; (5) Develop and recommend to the Board examination standards consistent with the statutory requirement; (6) Develop and recommend to the Board a code of ethics for licensed naturopathic doctors; and (7) Develop and recommend to the Board continuing education requirements for license renewal and reinstatement. #### Regulation .03-1 Naturopathic Doctors Formulary Council. *COMAR 10.32.21.03-1* A. The Council consists of the following members: (1) The Deputy Secretary for Public Health Services or the Deputy Secretary’s designee; and (2) The following members, appointed by the Board: (a) Two individuals who: (i) Are licensed in the State as naturopathic doctors; (ii) Practice naturopathic medicine in the State; (iii) Are certified by the North American Board of Naturopathic Examiners; and (iv) Have a minimum of 2 years experience; (b) Two licensed physicians who practice in the State; (c) One pharmacist who has a background in pharmacognosy and who practices in the State; and (d) One consumer of naturopathic services. B. Term of Appointment—Naturopathic Doctors Formulary Council. (1) The term of an appointed member of the Council is 4 years and is staggered. (2) At the end of a term, an appointed member continues to serve until a successor is appointed. (3) An individual may be reappointed for a second 4-year term but may not serve more than two consecutive 4-year terms. C. The terms of the initial members of the Naturopathic Doctors Formulary Council shall expire as follows: (1) In 2025: (a) One naturopathic doctor member; (b) One physician member; and (c) The consumer member; and (2) In 2027: (a) One naturopathic doctor member; (b) One physician member, and (c) The pharmacist member. D. A member of the Council may not receive compensation as a member of the Council, but is entitled to reimbursement for expenses under the Standard State Travel Regulations, as provided in the State budget. E. The Board shall designate the chair of the Council, whose term of office of the chair is 2 years. F. The Board shall provide staff for the Council. #### Regulation .03-2 Naturopathic Doctors Formulary Council and Board Duties. *COMAR 10.32.21.03-2* A. Council Duties. (1) The Council shall: (a) Develop and recommend to the Board a formulary for use by licensed naturopathic doctors; (b) Annually review the formulary adopted by the Board under §B(2) of this regulation to determine if any changes are necessary for compliance with current prescribing standards or the practice of naturopathic medicine; (c) Otherwise review the formulary at the direction of the Board; and (d) Make recommendations to the Board based on the reviews conducted under this regulation. (2) The Board shall adopt a formulary based on the Council's recommendations under this regulation. B. Board Duties. (1) The Board may modify or reject any recommendation of the Council regarding the formulary. (2) The formulary adopted by the Board shall be in accordance with Health Occupations Article, §14-5F-04.1, Annotated Code of Maryland. #### Regulation .04 Qualifications for Initial Licensure. *COMAR 10.32.21.04* A. To qualify for a license, an applicant shall meet the following requirements: (1) Be of good moral character; (2) Be at least 21 years of age; (3) Have a doctorate in naturopathic medicine from an approved naturopathic medical program; (4) Pass a competency based national naturopathic licensing examination part I and part II administered by the North American Board of Naturopathic Examiners or its successor agency that is consistent with federal standards of education and training; (5) Be physically and mentally capable of safely practicing naturopathic medicine with or without reasonable accommodation; and (6) If an applicant is licensed, certified, or registered to practice naturopathic medicine or any other health occupation in another state, be in good standing with the applicable state licensing, certification, or registration authority. B. To apply for a license, an applicant shall: (1) Submit an application to the Board on a form that the Board requires; (2) Pay to the Board an initial application fee as specified in Regulation .20 of this chapter; (3) Submit to the Board a written attestation as provided in Regulation .05 of this chapter; and (4) If the applicant has been licensed, certified, or registered to practice naturopathic medicine in another state, submit all evidence relating to: (a) Any disciplinary action taken or any administrative penalties assessed against the applicant by the appropriate state licensing, certification, or registration authority; and (b) Any consent agreements into which the applicant entered that contain conditions placed on the applicant’s professional conduct and practice, including any voluntary surrender of a license. C. Additional Requirements. An applicant shall submit to a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, by submitting to the Central Repository: (1) Two complete sets of legible fingerprints taken on forms approved by the Central Repository and the Federal Bureau of Investigation; and (2) All fees required by the Central Repository and the Federal Bureau of Investigation. D. The Board shall issue a license to an applicant who meets the requirements of this regulation. #### Regulation .05 Collaboration and Consultation Agreement and the Written Attestation. *COMAR 10.32.21.05* A. A collaboration and consultation agreement shall: (1) Include the name and license number of the physician with whom the applicant has the collaboration and consultation agreement; (2) State that the applicant will require patients to sign a consent form in plain language that: (a) The naturopathic doctor’s practice of naturopathic medicine is limited to the scope of practice identified in Health Occupations Article, §14-5F-14, Annotated Code of Maryland; and (b) Describes the differences in scope of practice between naturopathic doctors and physicians; (3) State that naturopathic doctors shall refer patients to and consult with physicians and other health care providers licensed or certified under the Health Occupations Article as needed; and (4) State that in cases where the naturopathic doctor diagnoses a patient with a life threatening condition, the naturopathic doctor shall: (a) Counsel and discuss with the patient the potential benefits offered by other physicians or other healthcare professionals; and (b) Attempt to make the appropriate referral. B. An applicant shall complete and submit to the Board a written attestation on a form supplied by the Board that states that the applicant has a collaboration and consultation agreement: (1) With a physician that is licensed in this State under Health Occupations Article, Title 14, Annotated Code of Maryland; and (2) That meets the requirements of §A of this regulation. C. An applicant shall inform the physician named as a collaborating physician in the attestation that the physician has been named. D. A licensee shall maintain a collaboration and consultation agreement that meets the requirements of this regulation in order to practice naturopathic medicine in the State. E. A licensee shall comply with the requirements of the licensee’s collaboration and consultation agreement with a physician. #### Regulation .06 Documentation for Initial Licensure. *COMAR 10.32.21.06* A. The applicant shall submit an application on a form supplied by the Board. B. A completed application shall include: (1) Verification of naturopathic medical education; (2) Documentation of successful completion of the examination requirements as described in Regulation .04A(4) of this chapter, including submission of all of the applicant’s scores sent directly to the Board from the examination authority or authorities; (3) A statement from the applicant listing all disciplinary or adverse actions taken against the applicant by a: (a) Hospital, related institution, alternative health system, or employer; (b) Medical board; (c) Licensing authority; (d) Court; or (e) Adjudicatory body; (4) All application and licensing fees payable to the Board at the time the application is submitted to the Board; (5) The applicant’s Social Security number, which the Board shall use only for evaluation and identification of applicants and licensees, but may not disclose in any other context; (6) Verification of licensure from all states where the applicant has ever held a license; (7) Verification of voluntary licensure nonrenewal or voluntary surrender of license while the applicant was in good standing and not under disciplinary charges or investigation at the time the license was surrendered from states where the applicant no longer holds a license; (8) A passport quality photograph; (9) Information in the National Practitioner Data Bank including, but not limited to, the following: (a) Medical malpractice judgments against the applicant; (b) Settlements made by the applicant in naturopathic medical malpractice actions; and (c) Actions taken against the applicant or the applicant’s license by state disciplinary or licensing authorities; (10) Documentation of competency in English by any of the following: (a) Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Documentation of graduation from a recognized English-speaking professional school; (c) Documentation of a passing score on the naturopathic licensing examination administered by the North American Board of Naturopathic Examiners; or (d) Documentation of receiving: (i) A score of at least 26 on the “Speaking Section” of the Internet-Based Test of English as a Foreign Language; or (ii) A score of Advanced or higher on the Oral Proficiency Interview; (11) A chronological list of: (a) All activities, beginning with the date of completion of naturopathic medical school through the date of application, listed by month and year, that account for all periods of time, and include each job held, regardless of whether the job was: (i) Medically related or not; and (ii) Compensated or not; (b) Any other activity engaged in, including all periods of unemployment; (c) Any actions, by a state licensing or disciplinary board, or a comparable body in the armed services, denying an application for licensure, reinstatement, or renewal; (d) Any actions taken against the naturopathic doctor’s license, by a state licensing or disciplinary board, or a comparable body in the armed services, including but not limited to limitations of practice, required education, admonishment, reprimand, suspension, or revocation for an act that would be grounds for disciplinary action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland; (e) Any investigation or charge brought against the naturopathic doctor by a licensing or disciplinary body or comparable body in the armed services; (f) Any medical or health professional license for which the naturopathic doctor has applied if the application was withdrawn for reasons that would be grounds for disciplinary action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland; and (g) Any investigation or charge brought against the naturopathic doctor by a hospital, related institution, or alternative health care system that would be grounds for action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland; (12) A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for a criminal act including: (a) A plea of guilty or nolo contendere, a conviction, or receipt of probation before judgment for an alcohol or controlled dangerous substance offense, including but not limited to driving while under the influence of alcohol or controlled dangerous substances; and (b) An arrest which would provide a basis for investigation or charge which would be grounds for disciplinary action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland; (13) A physical or mental condition that currently impairs the naturopathic doctor’s ability to practice medicine; (14) The filing or settling of a medical malpractice action in which the naturopathic doctor is, or has been, named as a defendant within the past 5 years; (15) The following additional information: (a) Copies of the complaints, pleadings, and judgments in all malpractice claims if the applicant has had 3 or more claims in the 5 years before the filing of the application for licensure; (b) Copies of all arrests, disciplinary actions, judgments, and final orders which occurred or were issued within the 7 years before submitting the application for licensure for driving while intoxicated, driving while under the influence of a chemical substance or medication, or any license probation, suspension, or revocation; and (c) All naturopathic medical licensure, certification, and recertification examination results and the dates when these examinations were taken; (16) If required by the Board and at the applicant’s expense, a physical or mental examination, or both, by a physician or evaluation program for treatment of impaired naturopathic doctors, or both, chosen by the Board to determine the applicant’s ability to practice naturopathic medicine; (17) On forms supplied by the Board, a release granting the Board access to relevant information from appropriate individuals, other institutions, and government agencies including, but not limited to: (a) The National Practitioner Data Bank; (b) Hospitals; and (c) Other licensing bodies; (18) On forms supplied by the Board, a release of any information which is not statutorily protected; (19) Certificates and verifications from the certifying or verifying authority sent directly from: the national licensing authority, the naturopathic educational institution, and other state’s licensing boards to the Board for applicants; (20) The certified translation of any of the documents required under this chapter, at the applicant’s expense, for any documents required by this chapter that are in a language other than English; and (21) The criminal history records information received from the Central Repository in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland, and Regulation .04C(1) of this chapter. C. Application Processing. (1) The Board has designated a 4-month period for acting on applications as follows: (a) Within 60 days after receipt of an application, the Board shall determine whether an application is complete; (b) If the Board determines that the application is not complete, the Board shall send a notice of deficiency to the applicant; (c) On receipt of the notice, the applicant shall correct the deficiency within 60 days or any other period specified in the notice; and (d) If the applicant fails to correct the deficiency within the required period, the application will be closed and the applicant shall be required to: (i) Submit a new application; and (ii) Pay the required fees specified in Regulation .20 of this chapter. (2) The Board may not issue a license until the Board has: (a) Received and reviewed the criminal history records information; and (b) Approved the application. D. Withdrawal of Application. (1) An applicant may not withdraw an application for initial licensure, renewal of a license, or reinstatement of a license without permission of the Board, if: (a) The applicant is currently charged in another jurisdiction with conduct which would be grounds for discipline under the Health Occupations Article, §14-5F-18, Annotated Code of Maryland, if the applicant were licensed in this State; (b) The applicant is under investigation in another jurisdiction for an allegation concerning conduct that would be grounds for discipline under Health Occupations Article, §14-5F-18, Annotated Code of Maryland, if the applicant were licensed in this State; or (c) The Board is investigating the applicant or application or has issued a notice of intent to deny licensure. (2) In determining whether to allow the withdrawal of a licensure application, the Board may consider such factors as the following: (a) Issues of competence or conduct which caused the matter to be investigated; (b) Duty to protect the public in other jurisdictions from duplicative expenditures on investigation of licensure applications; and (c) Truthfulness of the applicant during the application process. #### Regulation .07 Exceptions to Licensure Requirements. *COMAR 10.32.21.07* The following individuals do not need to be licensed in order to practice naturopathy in Maryland: A. An individual who is employed by the United States Government to practice naturopathic medicine while practicing within the scope of that employment; B. A student who is enrolled in an approved naturopathic medical program while the student is participating in a course of study under the supervision of a licensed naturopathic doctor or a licensed professional in the field of study; C. An individual who is licensed in another state to practice naturopathic medicine in the state for purposes of litigation may examine a patient, offer recommendations, and provide testimony; or D. A naturopathic doctor licensed by and residing in another jurisdiction, if the naturopathic doctor is engaged in consultation with the naturopathic doctor in the state about a particular patient and does not direct patient care. #### Regulation .08 Scope of Practice. *COMAR 10.32.21.08* A license authorizes a licensee, consistent with naturopathic education, training, and competence demonstrated by passing the Naturopathic Physician Licensing Examination, to: A. Order and perform physical and laboratory examinations for diagnostic purposes consistent with the education and training of naturopathic doctors, including: (1) Phlebotomy; (2) Clinical laboratory tests; (3) Orifical examinations; (4) Electrocardiograms with over read by a cardiologist; and (5) Physiological function tests; B. Order diagnostic imaging studies, interpret the diagnostic imaging reports and have access to the images from these studies. Naturopathic doctors shall not perform the imaging procedures nor directly interpret the images themselves; C. Dispense, order, or administer natural medicines, including, but not limited to, food, extracts of food, nutraceuticals, vitamins, amino acids, minerals, enzymes, botanicals and their extracts, and botanical medicines, homeopathic medicines and all dietary supplements and nonprescription drugs as defined by the Federal Food, Drug, and Cosmetic Act, as follows: (1) Except for intravenous administration, the naturopathic doctor may order or dispense natural medicines that use various routes of administration, including: (a) Oral; (b) Nasal; (c) Auricular; (d) Ocular; (e) Rectal; (f) Vaginal; (g) Transdermal; and (h) Intramuscular; and (2) The naturopathic doctor may only administer natural medicines through transdermal administration; D. Administer or perform hot or cold hydrotherapy, naturopathic physical medicine, electromagnetic energy and therapeutic exercise for the purpose of providing basic therapeutic care services, except that if a referral to another licensed provider is appropriate for ongoing rehabilitation or habilitation services, the naturopathic doctor shall make the referral; E. Provide health education and health counseling; and F. Perform naturopathic musculoskeletal mobilization. #### Regulation .09 Prohibited Actions. *COMAR 10.32.21.09* An individual who is solely licensed as a naturopathic doctor may not: A. Prescribe, dispense, or administer any prescription drug; B. Perform surgical procedures; C. Unless licensed under the Health Occupations Article, Annotated Code of Maryland, practice or claim to practice as: (1) A medical doctor or physician; (2) An osteopath; (3) A dentist; (4) A podiatrist; (5) An optometrist; (6) A psychologist; (7) A nurse practitioner; (8) A physician assistant; (9) A chiropractor; (10) A physical therapist; (11) An acupuncturist; or (12) Any other health care professional; D. Use general or spinal anesthetics; E. Administer ionizing radioactive substances for therapeutic purposes; F. Perform chiropractic adjustments or manipulations that include high velocity thrusts at or beyond the end range of normal joint motion unless the licensee is also a licensed chiropractor; or G. Perform acupuncture unless the licensee is also a licensed acupuncturist. #### Regulation .10 Renewals and Reinstatement. *COMAR 10.32.21.10* A. Renewals. (1) The Board may not renew a license until the Comptroller of Maryland has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment. (2) The term of a license renewed by the Board is 2 years from the date of renewal. (3) A license expires at the end of its term unless the license is renewed as provided by the Board. (4) At least 1 month before the license expires, the Board shall send to the licensee a renewal notice that states: (a) The date on which the current license expires; (b) The date by which the renewal application shall be received by the Board for the renewal to be issued before the license expires; and (c) The amount of the renewal fee as specified in Regulation .20 of this chapter. (5) The Board shall renew the license of a licensee who: (a) Submits a renewal application on the form that the Board requires; (b) Pays a renewal fee as specified in Regulation .20 of this chapter; (c) Is otherwise entitled to be licensed; (d) Meets the continuing education requirements as set forth in Regulation 11 of this chapter; (e) Provides evidence of biennial cardiopulmonary resuscitation certification; and (f) Attests that the licensee has a current collaboration and consultation agreement with a physician licensed in the State that meets the requirements of Regulation .05 of this chapter at the time of renewal.. (6) The failure to receive a renewal notice does not excuse a licensee from complying with §A(3) of this regulation. B. Reinstatement of an Expired or Lapsed License. An individual applying for reinstatement of a license to practice naturopathic medicine who failed to renew for any reason shall: (1) Complete a reinstatement application on a form supplied by the Board; (2) Pay the Board the reinstatement fee set by the Board in accordance with Regulation .20 of this chapter; (3) Complete a criminal history records check in accordance with Health Occupations Article §14-308.1, Annotated Code of Maryland; (4) Provide documentation of completion of at least 50 hours of approved continuing education earned during the 2-year period preceding the date of the submission of the application for reinstatement; and (5) Attest that the licensee has a current collaboration and consultation agreement with a physician licensed in the State that meets the requirements of Regulation .05 of this chapter at the time of reinstatement. (6) Meet any additional requirements set by the Board for reinstatement of a license. C. Reinstatement after Revocation of a License or After a Lapse in Renewal. (1) On the application of an individual whose license has been revoked, the disciplinary panel, on the affirmative vote of a majority of the quorum, may, in its discretion, reinstate a revoked license. (2) When a time period is not stated in an order for revocation, the disciplinary panel may not entertain an application for post-disciplinary reinstatement until at least 3 years after the date of the order. (3) The disciplinary panel may not entertain an application for post-disciplinary reinstatement after an order of revocation unless: (a) Any time period stated in the order has expired; (b) Any condition set out in the order has been fulfilled; (c) The applicant has filed a formal application and paid the fee set by the Board in Regulation .20 of this chapter; and (d) The applicant meets all of the requirements for reinstatement set out in §B of this regulation. (4) The disciplinary panel shall entertain applications for reinstatement pursuant to the procedures and standards of COMAR 10.32.02.06B. (5) A revocation of a license may not be for less than 1 year. (6) The disciplinary panel may not entertain applications for reinstatement if a revocation is permanent. (7) The applicant shall meet any additional requirements set by the Board for reinstatement of a license. D. After the expiration date of the license, the naturopathic doctor is no longer licensed to practice naturopathic medicine. #### Regulation .11 Continuing Education Requirements. *COMAR 10.32.21.11* A. Requirements. A licensed naturopathic doctor shall take at least 50 hours of continuing education credits during every 2-year renewal period: (1) For license renewal, preceding the expiration of the license for a naturopathic doctor; or (2) For license reinstatement, preceding the date of the submission of the application for reinstatement. B. The courses selected shall be approved by any of the following: (1) The American Association of Naturopathic Physicians; (2) The Maryland Association of Naturopathic Physicians; (3) The Accreditation Council for Continuing Medical Education; (4) The Accreditation Council for Pharmacy Education; (5) The North American Naturopathic Continuing Education Accreditation Council; or (6) A naturopathic doctor’s licensing authority or professional association of another state which meets the standards adopted by the American Association of Naturopathic Physicians. #### Regulation .12 Grounds for Discipline. *COMAR 10.32.21.12* Subject to the hearing provisions Health Occupations Article, §14-405, Annotated Code of Maryland, the Board, on the affirmative vote of a majority of its members then serving as a quorum of the Board, may deny a license to any applicant, or a disciplinary panel, on the affirmative vote of a majority of a quorum of the disciplinary panel, may reprimand any licensee, place any licensee on probation, or suspend or revoke a license of any licensee if the applicant or licensee: A. Is habitually intoxicated, or is addicted to or habitually abuses any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any drug without a valid prescription or indication, or provides professional services while under the influence of alcohol or using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; B. Has been found to be mentally incompetent by a physician if the mental incompetence impairs the ability of the applicant or licensee to undertake the practice of naturopathic medicine in a manner consistent with the safety of the public; C. Has entered into a consent agreement with or has been assessed an administrative penalty by a licensing authority in another state; D. Fraudulently or deceptively obtains, or attempts to obtain, or uses a license for the applicant, the licensee, or another; E. Has a license revoked or suspended, or was otherwise acted against, including the denial of licensure, by the licensing authority of another state; F. Uses false, deceptive, or misleading advertising; G. Advertises, practices, or attempts to practice under a name other than the applicant’s or licensee’s own name; H. Aids, assists, employs, or advises any unlicensed individual to practice naturopathic medicine; I. Willfully makes or files a false report or record in the practice of naturopathic medicine; J. Willfully or negligently fails to file a report or record as required by law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report; K. Pays or receives any commission, bonus, kickback, or rebate, or engages in any split-fee arrangement in any form with a licensed physician, organization, agency, or other person, either directly or indirectly, for patients referred to health care providers; L. Exercises influence within a patient-doctor relationship for purposes of engaging a patient in sexual activity; M. Engages in sexual misconduct with a patient; N. Fails to keep written medical records justifying the course of treatment of a patient; O. Engages in an act or omission that does not meet generally accepted standards of practice of naturopathic medicine or of safe care of patients, whether or not actual injury to a patient is established; P. Delegates professional responsibilities to an individual when the licensee delegating the responsibilities knows or has reason to know that the individual is not qualified by training, experience, or licensure to perform the responsibilities; Q. Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain; R. Breaches patient confidentiality; S. Is guilty of unprofessional or immoral conduct in the practice of naturopathic medicine; T. Offers, undertakes, or agrees to cure or treat a disease by a secret method, treatment, or medicine; U. Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; V. Sells, prescribes, gives away, or administers drugs for illegal or illegitimate purposes; W. Denies or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; X. Fails to cooperate with a lawful investigation of the Board; Y. Abandons a patient; or Z. Violates any provision of this title or this chapter. #### Regulation .13 Sanctioning Guidelines. *COMAR 10.32.21.13* A. Subject to provisions of Regulation .09A and B of this chapter, the disciplinary panel may impose sanctions as outlined in §B of this regulation on physicians for violations of Health Occupations Article, §§1-302, 14-404(a), and 14-504, Annotated Code of Maryland. B. Range of Sanctions. #### Regulation .14 Investigations and Hearings. *COMAR 10.32.21.14* A. Except as otherwise provided in State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, before the Board or a disciplinary panel takes any action under Health Occupations Article, §14-5F-18(a), Annotated Code of Maryland, the Board shall give the individual against whom the action is contemplated an opportunity for a hearing before the Board or disciplinary panel in accordance with the hearing requirements of Health Occupations Article, §14-405, Annotated Code of Maryland. B. Crime Involving Moral Turpitude. (1) On the filing of certified docket entries with the Board by the Office of the Attorney General, a disciplinary panel shall order the suspension of a license if the licensee is convicted or pleads guilty or nolo contendere with respect to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. (2) After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, a disciplinary panel shall order the revocation of a license on the certification by the office of the attorney general. C. The Board shall investigate any complaint filed with the Board that alleges that there are grounds for action under Health Occupations Article, §14-5F-18, Annotated Code of Maryland. D. An investigation and any reports and recommendations related to the investigation are confidential, subject to the exceptions under §E of this regulation. E. On the request of a person who has made a complaint to the Board, the Board shall provide the person with information on the status of the complaint. F. The Board shall give notice and the Board or disciplinary panel hold the hearing in accordance with the Administrative Procedure Act. G. The individual may be represented at the hearing by counsel. H. Over the signature of an officer or the administrator of the Board or disciplinary panel, the Board or disciplinary panel may issue subpoenas and administer oaths in connection with any investigation under Health Occupations Article, §14-5F-18, Annotated Code of Maryland, and any hearings or proceedings before the Board or disciplinary panel. I. If, without lawful excuse, a person disobeys a subpoena from the Board or an order by the Board to take an oath or to testify or answer a question, then, on petition of the Board, a court of competent jurisdiction may punish the person as for contempt of court. J. If, after due notice, the individual against whom the action is contemplated fails or refuses to appear, the Board or disciplinary panel may hear and determine the matter. K. Appeal. (1) Any person aggrieved by a final decision of the Board or a disciplinary panel under Health Occupations Article, §14-5F-01 et seq., Annotated Code of Maryland, in a contested case, as defined in the Administrative Procedure Act, may take a direct judicial appeal. (2) The appeal shall be made as provided for judicial review of final decisions in the Administrative Procedure Act. (3) An order of the Board or a disciplinary panel may not be stayed pending judicial review. (4) The Board may appeal from any decision that reverses or modifies an order of the Board or a disciplinary panel. L. The Board may issue a cease and desist order for: (1) Practicing naturopathic medicine without a license or with an unauthorized person; or (2) Supervising or aiding an unauthorized person in the practice of naturopathic medicine. #### Regulation .15 Cost of Bringing an Action Against a Licensee. *COMAR 10.32.21.15* A. If, after a hearing, a licensee is found to have violated provisions of Health Occupations Article, §14-5F-18, Annotated Code of Maryland, the Board shall impose a fee on the licensee that shall approximate the Board’s cost of bringing the proceedings against the licensee. B. The hearing costs may include any or all of the following expense items: (1) Services rendered by court reporters; (2) Transcriptions of the hearing record by court reporters; (3) Expenses related to witnesses appearing for the State; (4) Obtaining or reproducing documents, exhibits, or other evidentiary items; (5) Hearing-related per diems and expenses for Board members; or (6) Any other expenses directly related to the investigation and prosecution of the disciplinary action against the licensee. #### Regulation .16 Unauthorized Practice of Naturopathic Medicine and Title and Identification as Naturopathic Doctor. *COMAR 10.32.21.16* A. Except as otherwise provided in this chapter, an individual may not practice, attempt to practice, or offer to practice naturopathic medicine in this State without a license. An individual who violates this section: (1) Is guilty of a felony and upon conviction is subject to a fine not exceeding $10,000 or imprisonment not exceeding 5 years or both; and (2) Is subject to a civil fine of no more than $50,000 to be levied by the Board. B. Unless an individual is licensed to practice naturopathic medicine, the individual may not: (1) Represent to the public by title, by description, of service, methods, or procedures, or otherwise, that the individual is licensed by the Board to practice naturopathic medicine; (2) Use the title “doctor of naturopathic medicine”, “doctor of naturopathy”, naturopathic doctor”, or “naturopath”; or (3) Use the initials “N.D.”,” ND”, “NMD”, or “N.M.D.” after the name of the individual. C. An individual licensed to practice naturopathic medicine in this State may not use the title “physician”. D. A naturopathic doctor engaged in the private practice of naturopathic medicine in the state shall: (1) Wear an identification badge tag or badge which identifies that individual as a naturopathic doctor; and (2) Identify himself or herself to all patients as a naturopathic doctor. E. An individual may not identify himself or herself as a naturopathic doctor unless licensed by the Board. #### Regulation .17 Reporting Requirements. *COMAR 10.32.21.17* A. A licensed naturopathic doctor, a licensed health care practitioner, a health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland, located in the State, and a State agency shall file a written report with the Board if the person has information that gives the person reason to believe that a licensed naturopathic doctor is or may be: (1) Medically or legally incompetent; (2) Engaged in the unauthorized practice of naturopathic medicine; (3) Guilty of unprofessional conduct; or (4) Mentally or physically unable to engage safely in the practice of naturopathic medicine. B. This report shall be filed within 30 days of an individual or entity becoming aware of this information. C. A health care facility shall report promptly to the Board if: (1) A licensed naturopathic doctor voluntarily resigns from the staff of the health care facility, voluntarily limits the licensees staff privileges, or fails to reapply for hospital privileges at the health care facility; and (2) The action of the licensee occurs while the licensee is under formal or informal investigation by the health care facility for possible medical incompetence, unprofessional conduct, or mental or physical impairment. #### Regulation .18 Advertising. *COMAR 10.32.21.18* An advertisement may not contain: A. A statement containing misrepresentation of facts; B. Statements that cannot be verified by the Board for truthfulness; C. Statements likely to mislead or deceive because in context the statements make only a partial disclosure of relevant facts; D. Statements intended to, or likely to, create false or unjustified expectations of favorable results; E. Statements containing representations or implications that in reasonable probability can be expected to cause an ordinary prudent person to misunderstand or be deceived; F. Statements containing representations that a naturopathic doctor is willing to perform any procedure which is illegal under the laws or regulations of this State or the United States; G. Statements that are untruthful and improbable or contain, misstatements, falsehoods, misrepresentations, distorted, or fabulous statements as to cures; H. Statements that misrepresents the nature, characteristics, or qualities of natural medicines or services provided by a naturopathic doctor pursuant to Health Occupations Article, §14-5F-14(a)(3), (4), (5), (6), or (7), Annotated Code of Maryland; I. Statements that a manifestly incurable condition can be permanently cured; J. Statements promoting herbal, natural, or dietary supplements as drugs contrary to the laws, rules, and regulations of the Federal Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act of 1994; K. Advertising that does not comply with state or federal law, including the: (1) Federal Trade Commission Act, Section 12 of 15 U.S.C. §52; (2) Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301—397; (3) Maryland Food, Drug, and Cosmetic Act, Health-General Article, §21-207, et seq., Annotated Code of Maryland; and (4) Commercial Law Article, §14-2902, Annotated Code of Maryland; L. Statements recommending any modality of care that is inconsistent with the health, safety, and welfare of the public; or M. Statements made as defined in Health-General Article, §§21-247 and 21-248, Annotated Code of Maryland. #### Regulation .19 Code of Ethics. *COMAR 10.32.21.19* A. Naturopathic doctors shall concern themselves primarily with the welfare of the patient. B. A naturopathic doctor who suffers from a physical, mental, or emotional impairment, including substance abuse, that impacts the individual’s ability to practice naturopathic medicine shall seek professional treatment and refrain from the practice of naturopathic medicine until the impairment no longer exists or reasonable accommodations can be made. C. A naturopathic doctor shall: (1) Use professional discretion and integrity in relationships with a member of the health care community; (2) Be professional in conduct, with honesty, integrity, self-respect, and fairness; (3) Remain free from conflict of interest while fulfilling the objectives and maintaining the integrity of the naturopathic doctor profession; (4) Provide accurate fee information to the patient, the individual responsible for payment for treatment, and the insurer; (5) At all times respect the patient’s dignity, autonomy, and privacy; (6) Practice naturopathic medicine only as defined in the scope of practice set forth in Health Occupations Article, §14-5F-14(a), Annotated Code of Maryland; (7) Cooperate with any lawful investigation conducted by the Board, including: (a) Furnishing information requested in a timely manner as directed by the Board; (b) Complying with a subpoena; (c) Responding to a complaint at the request of the Board; and (d) Providing meaningful and timely access to relevant patient records; and (8) Report to the Board conduct in the practice of naturopathic medicine that indicates a violation of: (a) This chapter; (b) Health Occupations Article, Title 14-5F, Annotated Code of Maryland; or (c) Any other law, including, but not limited to, aiding or abetting the unauthorized practice of naturopathic medicine. D. A naturopathic doctor may not: (1) Misrepresent credentials, qualifications, or affiliations and shall attempt to correct others who misrepresent the naturopathic doctor’s credentials, qualifications, or affiliations; (2) Knowingly engage in or condone behavior that is fraudulent, dishonest, or deceitful, or involves moral turpitude; (3) Engage in a commercial activity which conflicts with the duties of a naturopathic doctor; (4) Perform naturopathic medicine on a patient if a contraindication against naturopathic doctor treatment exists; (5) Discriminate against a patient or a health care provider based on race, religion, age, gender, sexual orientation, national origin, or disability; (6) Intimidate, threaten, influence, or attempt to influence any person regarding any violation of law or regulation; or (7) Aid or abet any individual violating or attempting to violate any provision of law or regulation. E. A naturopathic doctor shall: (1) Use professional judgment in the use of evaluation and treatment procedures; (2) Decline to administer treatment if the naturopathic doctor believes that a treatment is contraindicated or unjustified; (3) Terminate a professional relationship with a patient in an appropriate manner, such as: (a) Providing the patient with sufficient notice to permit the patient to obtain the services of another professional; (b) Assisting the patient by providing referrals if appropriate; or (c) Continuing to provide emergency treatment to the patient if treatment is required before a reasonable time has passed to allow the patient to obtain the services of another health care provider; (4) Maintain a written record of treatment of the patient under the naturopathic doctor’s care for at least: (a) 5 years after the termination of treatment; and (b) 5 years after the patient becomes 18 years old, if applicable; (5) Make the written records of treatment available to the patient upon request, in compliance with applicable laws for disclosure of medical records; (6) Make arrangements for another professional to provide for the needs of the patient during anticipated absences when the naturopathic doctor is unavailable to the patient; (7) Make referrals only to other qualified and duly licensed health care providers; (8) Accurately inform the patient, other health care professionals, and the public of the limitations of the practice of naturopathic medicine; (9) Adequately assess the patient to determine if contraindications against naturopathic medical treatment exist and refer the patient to an appropriate health care practitioner; (10) Exercise independent professional judgment in the treatment or evaluation of the patient regardless of whether the patient was referred by another health care provider; (11) Ensure clear and concise professional communications with patients regarding: (a) Nature and duration of treatment; (b) Diagnoses; (c) Costs; (d) Billing; and (e) Insurance; and (12) Administer fair and equitable fees to patients regardless of status or insurance. F. A naturopathic doctor may not: (1) Accept a client for treatment, or continue unnecessary treatment, when the patient cannot be reasonably expected to benefit from the treatment; (2) Receive remuneration from, or provide remuneration to, or split a fee, for either making or accepting a referral of the patient to or from another health care provider; (3) Make a guarantee or promise about the efficacy of a particular treatment, the naturopathic doctor’s practice, or the result of a treatment unless supported by scientific principles accepted by the profession; or (4) Exploit the professional relationship by: (a) Continuing treatment unnecessarily; or (b) Charging for a service: (i) Not provided; or (ii) Different from those actually provided. G. A naturopathic doctor shall: (1) Maintain professional boundaries, even when the patient initiates crossing the boundaries of the professional relationship; and (2) Respect and maintain professional boundaries and respect the patient’s reasonable expectation of professional conduct. H. A naturopathic doctor may not: (1) Exploit a relationship with a patient, staff member, or student for the naturopathic doctor’s personal advantage including, but not limited to, a personal, sexual, romantic, or financial relationship; (2) Engage in a sexually intimate act with a patient; or (3) Engage in sexual misconduct, which includes, but is not limited to: (a) Therapeutic deception; (b) Non-bona-fide treatment; and (c) A sexually exploitative relationship. I. A naturopathic doctor may not engage in inappropriate behavior with other practice staff including sexual advances, harassment, discrimination, exploitation, retaliation, and other unprofessional conduct. J. A naturopathic doctor shall: (1) Respect and maintain the privacy and confidentiality of the patient; (2) Disclose the patient’s records or information about the patient only with the patient’s consent or as required by law; (3) Adequately safeguard confidential patient information, including storage and disposal of records; (4) Provide sufficient information to a patient to allow the patient to make an informed decision regarding treatment, including: (a) The purpose and nature of an evaluation or treatment regimen; (b) Alternatives to treatment; (c) Side effects and benefits of a treatment regimen proposed and alternatives to that treatment; (d) The estimated cost of treatment and alternatives to treatment; (e) The right of the patient to: (i) Withdraw from treatment at any time, including the risks associated with withdrawing from treatment; (ii) Decline to participate in treatment if an aspect of the treatment will be recorded, documented, photographed, observed, or otherwise used in an educational program; or (iii) Terminate any treatment contract at any time, for any or no reason, with no fee or penalty incurred; (5) Obtain the full informed consent of a patient participating in a human research program, without communicating a direct or implied penalty for the patient’s refusal to participate in the program and with due regard for the patient’s autonomy and dignity; (6) Comply with applicable federal and state laws for human research programs; and (7) Promptly and efficiently respond to any patient or Board request for records. K. A naturopathic doctor shall: (1) Obtain additional training, information, and supervision as needed to perform a new technique or service in a new specialty area or when employing a new treatment modality; and (2) Be current in the qualifications to practice, including meeting continuing education requirements as set forth in Regulation 11 of this chapter. L. The naturopathic doctor may not perform a treatment or provide a service that the naturopathic doctor is not qualified to perform or which is beyond the scope of the naturopathic doctor’s education, training, capabilities, experience, and scope of practice. M. A naturopathic doctor may not construe any failure to specify a particular ethical, legal, or professional duty in this chapter as a denial of the existence of other ethical, legal, or professional duties or responsibilities that are equally as important and generally recognized in the naturopathic medicine profession. N. A violation in this chapter may result in the Board taking action pursuant to Health Occupations Article, §14-5F-18, Annotated Code of Maryland. #### Regulation .20 Fees. *COMAR 10.32.21.20* The following fees are applicable to naturopathic doctors: A. Initial application fee — $790; B. Renewal Fee: (1) Biennial license renewal fee — $486; and (2) The Maryland Health Care Commission fee as determined by Maryland Health Care Commission under COMAR 10.25.03; C. License reinstatement fee—$700; and D. Written verification fee—$50. #### Regulation .21 Initial Licensure by Reciprocity. *COMAR 10.32.21.21* A. Requirements. An applicant for initial licensure by reciprocity shall: (1) Have an active, unrestricted license to practice naturopathic medicine in another jurisdiction that, at the time the applicant was licensed, had licensure requirements that were equivalent to or exceeded those set forth in Regulation .04A; (2) Be in good standing under the laws of every jurisdiction where the individual is licensed; and (3) Submit to a State and national criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland. B. Documentation. An applicant for initial licensure by reciprocity shall submit to the Board: (1) An application for reciprocity on a form provided by the Board; (2) The application fee as set by the Board; (3) Evidence of compliance with §A of this regulation; (4) A written attestation as provided in Regulation .05 of this chapter; (5) Any additional documentation set forth in Regulation .06 of this chapter that is needed for the Board to evaluate an application; (6) Any evidence relating to any disciplinary action taken or any administrative penalties assessed against the applicant by the appropriate state licensing, certification, or registration authority; and (7) Any consent agreements into which the applicant entered that contain conditions placed on the applicant’s professional conduct and practice, including any voluntary surrender of a license. C. The Board may not issue a license if the criminal history records information, pursuant to §A of this regulation, has not been received and reviewed. D. After a license is issued, the licensee is subject to the Board’s jurisdiction and shall comply with all laws and regulations governing the practice of naturopathic medicine in the State. ### Chapter 22 — Mandated Reporting to the Board **Authority:** Health Occupations Article, §§14-205(a)(2), 14-413, 14-414, 14-5A-18, 14-5B-15, 14-5C-18,14-5E-18, 14-5F-19, and 15-103, Annotated Code of Maryland **Administrative History:** Effective date: November 7, 2016 (43:22 Md. R. 1221) **Administrative History:** Regulation .02B amended effective January 1, 2018 (44:26 Md. R. 1215) **Administrative History:** Regulation .03 amended effective January 1, 2018 (44:26 Md. R. 1215) **Administrative History:** Regulation .05A amended effective January 1, 2018 (44:26 Md. R. 1215) #### Regulation .01 Scope. *COMAR 10.32.22.01* This chapter governs reporting requirements to the Board of Physicians concerning health care providers and naturopathic doctors by: A. Hospitals; B. Related institutions; C. Employers of allied health providers or naturopathic doctors; D. Health care facilities; E. State agencies; F. Health care practitioners; G. Naturopathic doctors; and H. Alternative health systems. #### Regulation .02 Definitions. *COMAR 10.32.22.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Abandon” means a health care provider’s withdrawal from the care and treatment of a patient during the course of treatment without giving reasonable notice to the patient or providing a competent replacement. (2) “Acts” means Health Occupations Article, Title 14, including subtitles 5A, 5B, 5C, 5E, and 5F, and Title 15, Annotated Code of Maryland. (3) “Administrative suspension” means an action imposed by a reporting entity restricting a health care provider’s privileges or hours or scope of employment for failure of the health care provider to comply with the bylaws, rules, policies, or procedures of the reporting entity. (4) “Allied health provider” means an individual who is licensed by the Board under Health Occupations Article, Title 14, Subtitles 5A, 5B, 5C, or 5E, or Title 15, Annotated Code of Maryland. (5) “Alternative health system” has the same meaning as alternative health care system as defined in Health Occupations Article, §1-401(a), Annotated Code of Maryland. (6) “Board” means the State Board of Physicians. (7) “Change” means any of the following actions by a reporting entity: (a) Terminating or failing to renew a health care provider’s staff privileges or employment or contract with the reporting entity; (b) Taking disciplinary action against a health care provider who continues to be employed, enjoy privileges, or contract with the reporting entity, including but not limited to: (i) Suspension; (ii) Placement on probation; or (iii) Restriction or limitation of privileges or duties; (c) Accepting an involuntary resignation as defined in this regulation; (d) Accepting or acquiescing to an involuntary leave of absence as defined in this regulation; (e) Accepting or acquiescing to an involuntary alteration in practice as defined in this regulation; (f) Requesting that a health care staffing entity cease furnishing the services of a particular health care provider; (g) In the case of a physician, denying: (i) By a hospital or related institution, an application for staff privileges; or (ii) By an alternative health care system, an application for employment; or (h) Terminating the delegation agreement of a physician assistant. (8) “Failure to report” means the failure of a reporting entity to file a report with the Board as mandated by this chapter. (9) “Focused professional practice evaluation (FPPE)” means any process used by a reporting entity to assess the competence or proficiency of a health care provider in a certain clinical skill, activity, or procedure. (10) “Focused review” has the same meaning as “focused professional practice evaluation” as defined in this regulation. (11) “Good standing” means the health care provider is not suspended, on probation, or subject to any pending disciplinary proceedings, an involuntary alteration in practice, or an involuntary leave of absence, as these terms are defined in this regulation. (12) “Health care facility” has the meaning stated in Health-General Article, §19-114, Annotated Code of Maryland. (13) “Health care provider” means a physician or an allied health provider. (14) “Health care staffing entity” means a business entity that contracts to provide, directly or indirectly, the personal health care services of one or more health care providers to a reporting entity. (15) “Hospital” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. (16) “Involuntary alteration in practice” means a modification in the privileges, employment, or contractual duties of a health care provider, whether self-initiated by the health care provider, mutually agreed upon, or requested or suggested by the reporting entity: (a) After the health care provider has been notified of pending discharge or termination of privileges or a contract, or pending proceedings possibly leading to discharge or termination of privileges or a contract; (b) While the health care provider is under investigation or subject to an inquiry, a practice review, a focused review, or an FPPE; (c) After the health care provider has been notified that an investigation or inquiry may begin; or (d) After the health care provider has been asked to respond to a complaint made to the reporting entity. (17) “Involuntary leave of absence” means a hiatus, however designated, during which a health care provider does not exercise staff privileges or fulfill the duties of employment or a contract, whether the hiatus was self-initiated, mutually agreed upon, or requested or imposed by the reporting entity, where the health care provider commenced the hiatus: (a) After being notified of pending discharge or termination of privileges or a contract, or pending proceedings possibly leading to discharge or termination of privileges or a contract; (b) While under investigation or subject to an inquiry, a practice review, a focused review, or an FPPE; (c) After being notified that an investigation or inquiry may begin; or (d) After being asked to respond to a complaint made to the reporting entity. (18) “Involuntary resignation” means a health care provider’s relinquishment of privileges, employment, or a contract with a reporting entity, whether the relinquishment was self-initiated, mutually agreed upon, or had been requested by the reporting entity, and however designated by the health care provider or the reporting entity, if the health care provider resigned: (a) After being notified that discharge or termination of privileges, employment, or a contract, or that proceedings possibly leading to discharge or termination of privileges, employment, or a contract, would occur if the health care provider would not resign; (b) While under investigation or subject to an inquiry, a practice review, a focused review, or an FPPE; (c) After being notified that an investigation or inquiry may begin; or (d) After being asked to respond to a complaint made to the reporting entity. (19) “Licensed physician” means an individual, including doctor of osteopathy, who is licensed by the Board to practice medicine. (20) “Mandated report” means any report required under the Acts or this chapter. (21) “Naturopathic doctor” means an individual who is licensed by the Board under Health Occupations Article, Title14, Subtitle 5F, Annotated Code of Maryland. (22) “Privileges” means authorization granted by a reporting entity to a health care provider to provide specific care, treatment, diagnostic services, or other services to patients. (23) “Related institution” has the meaning stated in Health-General Article, §19-301, Annotated Code of Maryland. (24) “Reporting entity” means: (a) A hospital, a related institution, or an alternative health system, as these terms are defined in this regulation; and (b) An employer of an allied health provider that is not a hospital, a related institution, or an alternative health system. (25) “Voluntary alteration in practice” means a modification in the privileges, employment, or contractual duties made with respect to a health care provider in good standing that is not an involuntary alteration in practice as defined in this regulation. (26) “Voluntary leave of absence” means a hiatus from providing health care services taken by a health care provider in good standing that is not an involuntary leave of absence as defined in this regulation. (27) “Voluntary resignation” means the relinquishment of privileges, employment, or a contract with a reporting entity taken by a health care provider in good standing that is not an involuntary resignation as defined in this regulation. #### Regulation .03 Mandated Reports. *COMAR 10.32.22.03* A. Subject to the limitations set out in §§B, C and D of this regulation, the reporting entity shall report to the Board in writing any change made with respect to a health care provider: (1) Whom the reporting entity employs; (2) Who works with the reporting entity under contract; or (3) To whom the reporting entity has granted privileges. B. A reporting entity shall inform the Board of any change that has been made, in whole or in part, because the reporting entity had reason to believe that the health care provider: (1) Abandoned a patient; (2) Provided patient care of questionable quality; (3) Disrupted the workplace; (4) Committed unethical or unprofessional conduct; (5) Committed billing or coding fraud; (6) Used the reporting entity’s employment or privileges to commit illegal or unethical business practices; (7) Suffers from a physical, a mental, or an emotional condition or impairment that affects the health care provider’s ability to perform the individual’s medical or surgical duties; (8) Is habitually intoxicated by alcohol or a controlled dangerous substance; (9) Provided care while under the influence of alcohol or while abusing or misusing any controlled dangerous substance or mood-altering substance; (10) Has not complied with the requirements of an alcohol or a drug treatment program; (11) With respect to allied health providers, failed to notify the reporting entity of the health care provider’s decision to enter into an alcohol or a drug treatment program; (12) Performed care beyond the scope of licensure or privileges or delegated duties, or delegated duties to an individual not authorized to perform those duties; (13) Repeatedly failed to complete medical records; (14) Repeatedly violated hospital bylaws, rules, policies, or procedures after warning; or (15) Committed any other act or suffered from any other condition which the reporting entity had reason to believe may constitute a violation of the Acts. C. Specific Changes Not Reportable. The following changes do not require reporting by a reporting entity: (1) Voluntary leaves of absence that: (a) Are not involuntary leaves of absence as defined in Regulation .02 of this chapter; (b) Are taken by a health care provider who is in good standing; and (c) May be caused by, for example: (i) Maternity leave; (ii) Family problems of a medical or other personal nature; (iii) Medical problems that do not implicate the health care provider’s physical, mental, or emotional ability to provide competent care; (iv) Military deployment; (v) Sabbaticals; (vi) Extended vacations; or (vii) Absences for professional training; (2) Voluntary resignations that: (a) Are not involuntary resignations as defined in Regulation .02 of this chapter; (b) Are submitted by a health care provider who is in good standing; and (c) May be caused by, for example: (i) A job or career change; (ii) The health care provider’s desire to relocate from Maryland; or (iii) The health care provider’s desire to retire; (3) Voluntary alterations in practice that: (a) Are not involuntary alterations in practice as defined in Regulation .02 of this chapter; (b) Are submitted by a health care provider who is in good standing; and (c) May be caused by, for example, a health care provider’s desire to: (i) Switch from active practice to consulting; (ii) Reduce workload; or (iii) Alter a specialty or scope of practice; (4) With respect to allied health providers, the initial denial of employment or privileges; (5) With respect to physicians, an involuntary alteration in practice that: (a) Results solely from an FPPE or a focused review; (b) Does not by itself or in combination with any other involuntary alteration in practice exceed 90 days in any one calendar year; (c) Consists solely of one or more of the following: (i) A program of additional training or monitoring or heightened scrutiny of the individual’s practice; or (ii) A requirement that the individual successfully perform a skill, an activity, or a procedure a specific number of times, or within a specific time period; and (d) Does not result from inappropriate sexual behavior, harassment, or any other unprofessional conduct in the workplace; (6) With respect to physicians, the initial denial of employment or privileges due solely to the applicant’s: (a) Inability to fulfill on-call requirements because of other time commitments; (b) Lack of a board certification required by the reporting entity; or (c) Lack of experience in conducting a particular medical procedure; (7) Administrative suspensions, if the sum total does not cumulatively exceed 30 days in any one calendar year, imposed on or agreed to by the health care provider, solely for the health care provider’s failure to: (a) Acquire mandated vaccinations or required serum titers for infections; (b) Attend required meetings; (c) Complete medical records; (d) Complete required training; or (e) Maintain or submit a certificate of professional insurance; (8) With respect to allied health providers and subject to the requirements of §D(1) and (2) of this regulation, entrance into an alcohol or a drug treatment program: (a) That is accredited by the Joint Commission; (b) That is certified by the Maryland Department of Health; (c) To which the allied health provider is referred by the Maryland Physician Health Program or the Maryland Healthcare Professionals Program; or (d) Provided by a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse; or (9) With respect to physicians and subject to the requirements of §D(3) and (4) of this regulation, entrance into an alcohol or a drug treatment program: (a) That is accredited by the Joint Commission; (b) That is certified by the Maryland Department of Health; or (c) To which the physician is referred by the Maryland Physician Health Program. D. Exceptions to §C(8) and (9) of This Regulation. (1) Section C(8) of this regulation applies only where: (a) The allied health provider notified the reporting entity at the time the allied health provider decided to enter the program; (b) The reporting entity is able to verify that the allied health provider remains continually in the program until properly discharged; and (c) The action or condition of the allied health provider had not caused injury to any individual during the provision of health care by the allied health provider. (2) Section C(8) of this regulation does not apply to: (a) Any change made by a reporting entity relating to the discharge of an allied health provider from an alcohol or a drug treatment program, when that discharge was for non-attendance or non-compliance with the program; (b) Additional changes made by the reporting entity, other than minor scheduling changes made solely to accommodate participation in the program; or (c) Any change made by the reporting entity based on events set out in Regulation .03B which occurred subsequent to the provider’s entrance into the alcohol or drug treatment program. (3) Section C(9) of this regulation applies only where: (a) The physician notified the reporting entity at the time the physician decided to enter the program; (b) The reporting entity is able to verify that the physician remains continually in the program until properly discharged; and (c) The action or condition of the physician had not resulted in injury to any individual during the provision of health care by the physician. (4) Section C(9) of this regulation does not apply to: (a) Any change made by a reporting entity relating to the discharge of a physician by an alcohol or a drug treatment program, when that discharge was for non-attendance or non-compliance with the program; (b) Additional changes made by the reporting entity, other than minor scheduling changes made solely to accommodate participation in the program; or (c) Any change made by the reporting entity relating to events set out in §B of this regulation which occurred subsequent to the physician’s entrance into the alcohol or drug treatment program. #### Regulation .04 Naturopathic Doctors. *COMAR 10.32.22.04* A. A licensed naturopathic doctor, other licensed health care practitioner, health care facility located in the State, or State agency shall file a written report to the Board if there is reason to believe that a licensed naturopathic doctor is or may be: (1) Medically or legally incompetent; (2) Engaged in the unauthorized practice of naturopathic medicine; (3) Guilty of unprofessional conduct; or (4) Mentally or physically unable to engage safely in the practice of naturopathic medicine. B. The report required under §A of this regulation shall be filed with the Board within 30 days after the individual or entity becomes aware of this information. C. A health care facility shall report within 10 days to the Board if a licensed naturopathic doctor voluntarily resigns from the staff of the health care facility, voluntarily limits staff privileges, or fails to reapply for hospital privileges at the health care facility while the naturopathic doctor is under formal or informal investigation by the health care facility for possible medical incompetence, unprofessional conduct, or mental or physical impairment. #### Regulation .05 Time Frames for the Submission of Reports. *COMAR 10.32.22.05* A. Physicians. (1) A reporting entity shall file reports required under this chapter with the Board within 10 days of any change made with regard to a physician. (2) Within 10 days, the reporting entity who has reported a change to the Board under this chapter shall report to the Board in writing any modifications made to, or subsequent developments in, that change. B. Allied Health Providers. (1) Except as provided in §B(2) of this regulation, a reporting entity shall file any report required under this chapter within 10 days of any change made with respect to allied health providers. (2) With respect to physician assistants: (a) An employer of a physician assistant who terminates the physician assistant because of a quality of care issue shall report the termination within 5 days of the termination; (b) A physician or an employer who terminates a delegation agreement with a physician assistant shall report that termination within 10 days; and (c) A report submitted under §B(2)(b) of this regulation may not be used to fulfill the requirement of §B(2)(a) of this regulation. C. Naturopathic Doctors. (1) Within 30 days, a licensed naturopathic doctor, other licensed health care provider, health care facility located in the State, or State agency shall file a written report with the Board upon becoming aware of information described in Regulation .04A of this chapter. (2) Within 10 days, a health care facility shall report to the Board any information required under Regulation .04C of this chapter. #### Regulation .06 Enforcement. *COMAR 10.32.22.06* A. The Board shall conduct any necessary investigation regarding failure of a reporting entity to file a report required under this chapter. B. Over the signature of an officer, the executive director, or the deputy director, the Board may issue subpoenas in connection with any investigation or proceeding to enforce this chapter. C. Before submission of the final investigative report to the Board, the investigator shall inform the reporting entity of the allegation of failure to report and offer the reporting entity an opportunity to submit a written response. Any written response shall be made part of the investigative report. The investigative report is confidential and may not be released to any person except as provided in §E of this regulation. D. The final investigative report shall be submitted to the Board. The Board, after consideration of the investigative report, shall: (1) If it finds probable cause that the reporting entity failed to report as required by this chapter, vote to issue a notice of failure to file a report setting out the facts of the alleged failure and the recommended civil penalty as set out in §O of this regulation; or (2) Dismiss the case. E. If the Board votes to issue a notice of failure to file a report, the Board shall mail by first class mail the notice of failure to file a report to the reporting entity involved. Upon this mailing, the Board shall make available to the reporting entity the investigative report, less the names of any confidential informants who will not be called as witnesses in the case. F. If the reporting entity does not request a hearing within 30 days of the date the notice of failure to file a report was mailed, the notice of failure to file a report shall become final and shall constitute a final disposition of the Board. G. A reporting entity which has timely filed a request for a hearing may choose to attend a settlement conference with a committee of the Board to attempt to resolve a case. If a settlement conference is convened: (1) The reporting entity may be represented by counsel; (2) Except for consideration of a proposed resolution of the case, the Board may not use any commentary, admissions, facts revealed, or positions taken at the settlement conference, unless the subject matter is available from other sources or is otherwise discovered; (3) At the conclusion of the settlement conference, the committee shall recommend either: (a) Dismissing the notice of failure to file a report; or (b) Upholding the notice of failure to file a report and imposing a civil penalty as set out in §O of this regulation. H. If the reporting entity agrees with the recommendation of the settlement committee, the Board shall consider the recommendation and either accept or reject it. The Board’s acceptance of the settlement committee’s recommendation constitutes the Board’s final disposition of the case. I. If a settlement is not reached or if the settlement committee’s recommendation is not approved by the Board, the case shall proceed to a hearing before the Board. J. The hearing ordinarily shall be limited to oral argument before the Board. The issues at the hearing are limited to whether a reporting entity: (1) Made a change as defined in this chapter; (2) Had reason to believe that the change was made, in whole or in part, because of a reason listed in Regulation .03B of this chapter; (3) Reported the change to the Board; and (4) Reported the change within the time frames set out in this chapter. K. The Board chair or alternate presiding officer may reasonably limit the time for oral argument. L. The Board shall conduct an evidentiary hearing if the chair or alternate presiding officer finds that there is a substantial dispute concerning one or more of the material facts set out in §J of this regulation. If there is an evidentiary hearing, the Board chair or alternate presiding officer may: (1) Administer oaths or affirmations; (2) Issue subpoenas for relevant evidence; (3) Make all rulings on the admission of evidence; (4) Rule on motions; (5) Exclude repetitive or irrelevant evidence, require the parties to narrow the factual evidence to the relevant issues, and make any other rulings in order to focus and expedite the proceeding; (6) Require proffers of evidence in advance of the hearing and make evidentiary rulings before the commencement of the hearing; and (7) Reasonably limit the time for presentations. M. It is not a defense to the allegation of a failure to report that: (1) An employee of the reporting entity was not aware of: (a) The change made by the reporting entity; or (b) The obligation to report; or (2) The reporting entity was conducting its own proceeding to further evaluate the change or the reasons for the change. N. If the Board finds after the hearing that the reporting entity did not fail to file any report required by this chapter, the Board shall issue a final disposition dismissing the notice of failure to file a report. O. If the Board finds after a hearing that a reporting entity failed to file any report required by this chapter, the Board shall issue a final disposition with findings of fact, conclusions of law, and civil penalty. In its final disposition, the Board may impose a civil penalty as follows: (1) With respect to reports concerning physicians: (a) $2,500 for the first occurrence in a calendar year; or (b) $5,000 for any subsequent occurrence in a calendar year; and (2) With respect to reports concerning allied health providers: (a) $500 for the first occurrence in a calendar year; or (b) $1,000 for any subsequent occurrence in a calendar year. P. The Board disposition is the final administrative action on the matter. Q. A reporting entity that is dissatisfied with a final disposition of the Board may seek judicial review of the Board’s final disposition as provided in the Administrative Procedure Act. The disposition of the Board may not be stayed pending judicial review. R. The Board shall pay all monies collected pursuant to this chapter into the State’s General Fund. The Board may refer any uncollected civil penalties under this regulation to the Central Collection Unit of the State. S. The investigative and quasi-judicial procedures set out in this regulation, and the confidentiality provisions of Regulation .07 of this chapter, apply to licensed naturopathic doctors, other licensed health care providers, health care facilities located in the State, and State agencies with respect to any allegations that they failed to file a report required under Regulation .04 of this chapter. #### Regulation .07 Confidentiality. *COMAR 10.32.22.07* A report made to the Board under this chapter is not subject to subpoena or discovery in any civil action other than a proceeding arising out of a hearing and the final disposition of the Board or disciplinary panel. #### Regulation .08 Public Notice of Failure to File a Report and Disposition. *COMAR 10.32.22.08* A. The notice of failure to file a report and any final disposition under this chapter are public documents. B. The notice of failure to file a report and any final disposition shall redact: (1) The name of a patient and any other patient-identifying information; and (2) Records of a health care provider’s or a naturopathic doctor’s physical, mental, or emotional condition, except to the extent necessary to identify the deficient practice or condition that caused an entity to make a change as defined in Regulation .02 of this chapter. ### Chapter 23 — Permits for the Dispensing of Prescription Drugs **Authority:** Health Occupations Article, §§12-102, 14-205, 14-306, 14-404, and 14-408; State Government Article, §§10-206 and 10-226; Annotated Code of Maryland **Administrative History:** Effective date: March 26, 2018 (45:6 Md. R. 320) #### Regulation .01 Scope. *COMAR 10.32.23.01* This chapter defines the parameters under which a physician may obtain a permit to dispense prescription drugs to that physician’s patients, dispense prescription drugs to the patients of other prescribers under certain circumstances, and delegate parts of the dispensing process to others in accordance with Health Occupations Article, §§12-102 and 14-306, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.32.23.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Physicians. (2) “Controlled dangerous substance (CDS)” has the meaning stated in Criminal Law Article, §5-101(g), Annotated Code of Maryland. (3) “Dispense” has the meaning stated in Health Occupations Article, §12-101, Annotated Code of Maryland. (4) “Drug sample” has the meaning stated in 21 CFR §203.3(i). (5) Final Check. (a) “Final check” means the verification of the accuracy and completeness of a filled prescription order by the permit holder before the drug is dispensed to the patient. (b) “Final check” includes the assumption of responsibility for the filled prescription, including verifying the: (i) Appropriateness of the dose; (ii) Accurate expiration date; (iii) Accuracy of the drug dispensed; (iv) Strength of the drug dispensed; (v) Labeling that complies with Health Occupations Article, §12-505, Annotated Code of Maryland; and (vi) Appropriateness of the container in which the drug is dispensed, including child-proof containers where applicable. (6) “In good standing” means that an individual: (a) Holds a license to practice medicine in this State; (b) Is not currently suspended by any order imposed by any medical licensing board; (c) Is not currently on probation by any order imposed by any medical licensing board; (d) Is not currently subject to any restrictions on practice related to the abuse, misuse, or improper prescribing of drugs; (e) Has not been within the past 5 years sanctioned by any medical licensing board for the commission of a crime of moral turpitude or for a violation of Health Occupations Article, §14-404(a)(7), (8), (9), (10), or (28), Annotated Code of Maryland, or a similar statute of another state; and (f) Has not within the past 5 years had the CDS registration issued by the OCSA or its predecessor, the registration issued by the federal Drug Enforcement Agency, or the Board dispensing permit: (i) Revoked; (ii) Suspended; or (iii) Voluntarily relinquished or surrendered while under investigation or after being informed that an investigation will be commenced. (7) “In the public interest” means that a pharmacy is not conveniently available to the patient. (8) Mechanical Act. (a) “Mechanical act” means an act which does not require professional judgment, medical or pharmaceutical training, or discretion. (b) “Mechanical act” does not include: (i) Selecting a drug; (ii) Labeling; (iii) Measuring or calculating dosages; (iv) Substituting one drug for another, including substituting a generic or brand drug for the prescribed drug; (v) Substituting one dosage form of a drug for another; (vi) Altering the route of administration; or (vii) Counseling patients. (9) “OCSA” means the Office of Controlled Substances Administration of the Maryland Department of Health. (10) “Permit holder” means a physician licensed in this State who holds a valid dispensing permit under this chapter. (11) “Readily retrievable” means maintained by any method by which the permit holder can retrieve and produce the record to OCSA during the course of an unscheduled on-site inspection. (12) “Sample unit” has the meaning stated in 21 CFR §203.3 (aa). (13) “Supplier” means: (a) A wholesale distributor as defined in Health Occupations Article, §12-6C-01(v), Annotated Code of Maryland; or (b) A pharmacy, to the extent permitted by Health Occupations Article, §12-406(b), Annotated Code of Maryland. #### Regulation .03 Permit Not Required. *COMAR 10.32.23.03* A dispensing permit is not required to: A. Dispense prescription drugs or devices at a health facility or center described in Health Occupations Article, §12-102(g)(1)—(3), Annotated Code of Maryland; or B. Dispense to a patient, free of charge: (1) A drug sample; (2) A sample unit; or (3) A starter dosage of a prescription drug, not to exceed a 72-hour supply. #### Regulation .04 Qualifications for Dispensing Permits. *COMAR 10.32.23.04* A. An applicant for a dispensing permit shall: (1) Possess a license to practice medicine in this State; (2) Be in good standing as that term is defined in this chapter; (3) Be of good moral character; (4) Demonstrate a basic knowledge of the statutes and regulations governing the practice of dispensing prescription drugs; (5) Complete the application on a form supplied by the Board; and (6) Pay the required fee as set out in COMAR 10.32.01.12. B. The applicant shall: (1) State each location at which prescription drugs will be dispensed; and (2) Grant permission to OCSA to inspect each location at which drugs will be dispensed at any reasonable hour. C. An applicant for renewal of a dispensing permit shall submit, upon request, documentation of completion of at least ten continuing education credits related to the preparing and dispensing of prescription drugs offered by the Accreditation Council for Pharmacy Education or as approved by the Secretary of the Maryland Department of Health. #### Regulation .05 Consideration of Applications. *COMAR 10.32.23.05* The Board shall grant the application for a dispensing permit if: A. The applicant meets the requirements of Regulation .04 of this chapter; B. The applicant has not been sanctioned by the Board for dispensing drugs without a permit within the last 5 years; and C. Granting the application is in the public interest. #### Regulation .06 Requirements for Permit Holders. *COMAR 10.32.23.06* A. A permit holder shall comply with all federal and State statutes and regulations regarding prescription drugs, including all requirements for: (1) Dispensing, including labeling; (2) Storing and securing inventory; (3) Allowing access only to authorized individuals; (4) Managing inventory controls; (5) Recordkeeping; and (6) Submitting prescription monitoring data to the Maryland Prescription Drug Monitoring Program in accordance with Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland. B. A permit holder shall: (1) Perform in person the final check of each drug dispensed; (2) Sign or initial documentation in person that the final check was completed; (3) Be present on the premises and available for consultation at the time the drug is dispensed; (4) With regard to inspections by the OCSA: (a) Personally sign at the time of the inspection the acknowledgement of receipt of the inspection report required by Health Occupations Article, §12-102(c)(2)(ii)4D, Annotated Code of Maryland; or (b) Assure that during all normal office hours a designee is available on the premises who will sign at the time of the inspection the acknowledgement of receipt of the inspection report; (5) Assure that the lot number of a drug obtained from a stock bottle or other larger container: (a) Is recorded in the office records; (b) Can be correlated with any patient’s prescription for that drug; and (c) Is immediately available for inspection; and (6) Except with regard to sample units, drug samples, and starter dosages in the possession and control of an authorized prescriber, assure that physical access to all prescription drugs is denied to all individuals at all times that a permit holder is not on the premises. C. A permit holder may not dispense medications by: (1) Mail order; or (2) A refill. D. For the purposes of this regulation, “refill” means an additional allotment of the same drug initially authorized by the original, written prescription. “Refill” does not prohibit a permit holder from dispensing the same or different drug through an additional or subsequent, written prescription. #### Regulation .07 Delegation of Dispensing Functions. *COMAR 10.32.23.07* A. A permit holder may delegate to an unlicensed person only mechanical acts involved in dispensing a drug. B. Delegation to a Physician Assistant. (1) Except as required in §B(2) of this regulation, a permit holder may delegate to a physician assistant with whom the permit holder has a delegation agreement under Health Occupations Article, §15-302, Annotated Code of Maryland, the dispensing of a drug prescribed by: (a) The permit holder to the permit holder’s patient; or (b) A physician assistant or certified registered nurse practitioner who meets the requirements of Regulation .08 or .09 of this chapter. (2) The permit holder shall perform the final check. #### Regulation .08 Dispensing Prescription Drugs Prescribed by Physician Assistants. *COMAR 10.32.23.08* A. Except as required in §§B and C of this regulation, a permit holder may dispense a drug prescribed by a physician assistant with whom the permit holder has a delegation agreement under Health Occupations Article, §15-302, Annotated Code of Maryland, which authorizes the physician assistant to prescribe the drug. B. The permit holder shall perform the final check. C. The permit holder may dispense under this regulation only a drug that the permit holder is authorized to prescribe. #### Regulation .09 Dispensing Prescription Drugs Prescribed by Certified Registered Nurse Practitioners. *COMAR 10.32.23.09* A. Except as required in §§B and C of this regulation, a permit holder may dispense a drug prescribed by a certified registered nurse practitioner who is: (1) Authorized under Health Occupations Article, Title 8, Annotated Code of Maryland, to prescribe the drug; and (2) Working with the permit holder in the same office setting. B. The permit holder shall perform the final check. C. The permit holder may dispense under this regulation only a drug that the permit holder is authorized to prescribe. #### Regulation .10 Records. *COMAR 10.32.23.10* A. A permit holder shall keep readily retrievable at each dispensing location: (1) A copy of the dispensing permit issued by the Board; (2) A record of each final check; (3) A copy of the form, signed and dated by the patient, maintained in accordance with COMAR 10.13.01.04, indicating the patient’s determination that a pharmacy is not conveniently available and demonstrating that the determination was made solely by the patient; (4) The delegation agreement of any physician assistant for whom the permit holder dispenses prescription drugs at that location, including the name of the primary supervising physician and any alternate supervising physician; (5) A list of the name and license number of all physician assistants for whom the permit holder dispenses drugs at that location; (6) A list of the name, license number, and specialty of all certified registered nurse practitioners for whom the permit holder dispenses drugs at that location; (7) The permit holder’s protocols for handling drug recalls, including the arrangements for notifying patients; (8) The permit holder’s protocols for disposal of drugs; (9) With respect to suppliers from whom the permit holder purchased prescription drugs: (a) The name, address, and phone number of each supplier; and (b) Documentation including: (i) For any pharmacy supplier, the number and the expiration date of the pharmacy permit issued by the Maryland Board of Pharmacy and the number and expiration date of the CDS registration issued by OCSA; and (ii) For each wholesale supplier, the number and the expiration date of the distribution permit issued by the Maryland Board of Pharmacy and the number and expiration date of the CDS registration issued by OCSA; and (10) Any other purchasing, inventory, and dispensing records required by State or federal statutes or regulations. B. In addition to meeting the requirements of Regulation .10A, the permit holder shall comply with any other State or federal law or regulation relating to dispensing of prescription drugs. C. A permit holder who dispenses CDS shall keep additional records available for inspection as required by COMAR 10.19.03.05. #### Regulation .11 Revision of Dispensing Permit. *COMAR 10.32.23.11* A permit holder may revise a permit twice during its term, without charge, to change the location at which prescriptions will be dispensed. #### Regulation .12 Lapse of Dispensing Permit. *COMAR 10.32.23.12* A. A permit automatically lapses if the permit holder: (1) Dies; (2) Fails to retain a valid and active Maryland medical license; (3) Fails without good cause to file the annual report required by Health Occupations Article, §12-102(c)(2)(ii)4L, Annotated Code of Maryland, within 15 days of the anniversary date of the date the permit was issued; or (4) Fails without good cause to notify the Board of a change of address as required by Health Occupations Article, §14-316(f), Annotated Code of Maryland. B. A lapsed permit may not be reinstated. C. The lapse of a permit is not in itself a bar to filing an application for a new permit. #### Regulation .13 Written Notice on Reactivation of Dispensing. *COMAR 10.32.23.13* A permit holder who has reported pursuant to Health Occupations Article, §12-102(c)(2)(ii)4L, Annotated Code of Maryland, that the permit holder has not personally dispensed prescription drugs during the previous year: A. Will not be subject to inspections by OCSA pursuant to Health Occupations Article, §12-102.1(b), Annotated Code of Maryland, unless the permit holder begins dispensing again; and B. May not begin to dispense prescription drugs again during the term of the dispensing permit without notifying the Board in advance in writing. #### Regulation .14 Grounds for Revocation of Dispensing Permit. *COMAR 10.32.23.14* A. Subject to the Administrative Procedure Act, and in addition to any sanction for violation of Health Occupations Article, §14-404(a)(28), Annotated Code of Maryland, the Board may revoke a dispensing permit on any of the following grounds: (1) Violating the attestations made pursuant to COMAR 10.13.01.05C(4); (2) Violating State or federal statutes or regulations regarding prescribing or dispensing prescription drugs; (3) Delegating dispensing duties outside the scope of this chapter; (4) Dispensing prescription drugs prescribed by another outside the scope of this chapter; (5) Dispensing at a location not designated on the permit; (6) Being absent from the premises when prescription drugs are dispensed under the permit; (7) Failing to comply with the applicable requirements of the Prescription Drug Monitoring Program set out in Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland; (8) Failing to cooperate with an investigation by the Board or an inspection by OCSA; or (9) Violating Regulations .06, .10, or .13 of this chapter. B. If a permit holder surrenders the permit while under investigation: (1) The surrender does not prevent the Board from taking any appropriate disciplinary action under Health Occupations Article, §14-404(a)(28), Annotated Code of Maryland, or any other statute under which the Board has jurisdiction; and (2) The permit holder may not apply for another permit again for a minimum of 5 years. #### Regulation .15 Summary Suspension of Dispensing Permit. *COMAR 10.32.23.15* A. The Board may summarily suspend a dispensing permit if it finds that the public safety, health, or welfare imperatively requires emergency action. B. Procedures for summary suspension shall be governed by COMAR 10.32.02.08. #### Regulation .16 Fraud or Deception in Obtaining a Permit. *COMAR 10.32.23.16* Subject to the Administrative Procedure Act, a licensee who fraudulently or deceptively obtains or attempts to obtain a permit is guilty of violating Health Occupations Article, §14-404(a)(1), Annotated Code of Maryland. #### Regulation .17 Permit Holders Sanctioned for Violating the Medical Practice Act. *COMAR 10.32.23.17* A. If the Board sanctions a permit holder for violating Health Occupations Article, §14-404(a)(7), (8), (9), (10), or (28), or §14-404(b), Annotated Code of Maryland, the Board shall, in addition to any sanctions imposed on the permit holder under COMAR 10.32.02.07 or 10.32.02.10, revoke the permit. B. Subject to the requirement of §C of this regulation, reinstatement of a revoked permit is at the discretion of the Board. C. A revoked permit may not be reinstated for a minimum of 5 years from the date of revocation. #### Regulation .18 Dispensing Without a Permit. *COMAR 10.32.23.18* Unless otherwise authorized by Health Occupations Article, §12-102, Annotated Code of Maryland, the dispensing of prescription drugs by a physician without a permit is a violation of Health Occupations Article, §14-404(a)(28), Annotated Code of Maryland, and also may be considered unprofessional conduct in the practice of medicine in violation of Health Occupations Article, §14-404(a)(3)(ii), Annotated Code of Maryland. #### Regulation .19 Interpretation. *COMAR 10.32.23.19* Nothing in this chapter relieves any permit holder from meeting the requirements of State or federal law or COMAR 10.13.01. ### Chapter 24 — Licensure of Genetic Counselors **Authority:** Health Occupations Article, §§1-606, 14-205, and 14-5G-01—14-5G-29, Annotated Code of Maryland **Administrative History:** Effective date: September 01, 2025 (52:17 Md. R. 874) #### Regulation .01 Scope. *COMAR 10.32.24.01* A. This chapter governs the practice of genetic counseling. B. Except as provided in §§C— D of this regulation, on or after January 1, 2024, an individual shall be licensed by the Board before the individual may practice genetic counseling. C. This chapter does not prohibit any student who is currently enrolled in an accredited educational program to qualify for a license as a genetic counselor from performing any of the procedures described in this chapter as part of that program’s clinical curriculum on genetic counseling. D. This chapter does not prohibit an individual from practicing a health occupation that the individual is authorized to practice under Health Occupations Article, Annotated Code of Maryland. #### Regulation .02 Incorporation by Reference. *COMAR 10.32.24.02* The National Society of Genetic Counselors Code of Ethics (1992, revised 2017) is incorporated by reference. #### Regulation .03 Definitions. *COMAR 10.32.24.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accredited educational program” means an educational program that is accredited by the national accrediting council or an equivalent accrediting body recognized by the national certifying board. (2) “Board” means the State Board of Physicians. (3) “Certified genetic counselor” means an individual certified as a genetic counselor by a national certifying board. (4) “Committee” means the Genetic Counseling Advisory Committee established under Health Occupations Article, §14-5G-05, Annotated Code of Maryland. (5) “Disciplinary panel” means a disciplinary panel of the Board established under Health Occupations Article, §14-401, Annotated Code of Maryland. (6) Genetic Assessment. (a) “Genetic assessment” means the integration of genetic laboratory test results and other diagnostic studies with the medical histories of a patient and the patient’s family members to assess the risk for the patient or the patient’s family members of: (i) A genetic or medical condition or disease; and (ii) The recurrence of a genetic or medical condition or disease. (b) “Genetic assessment” includes taking medical and family histories for the purpose of genetic counseling. (7) “Good standing” has the meaning stated in COMAR 10.32.22.02. (8) “Immediately available” means a qualified supervisor is able to provide necessary direction in person, by telephone, or by other electronic means. (9) “License” means a license issued by the Board to practice genetic counseling. (10) “Licensed genetic counselor” means an individual who is licensed by the Board, in accordance with Health Occupations Article, Title 14, Subtitle 5G, Annotated Code of Maryland, to practice genetic counseling as a genetic counselor in the State. (11) “Licensee” means a licensed genetic counselor or a supervised genetic counselor. (12) “National accrediting council” means the Accreditation Council for Genetic Counseling, or its successor, that accredits education programs for genetic counselors. (13) “National certifying board” means the American Board of Genetic Counseling, its predecessor, or its successor, that certifies genetic counselors. (14) Practice Genetic Counseling. (a) “Practice genetic counseling” means: (i) Obtaining and evaluating the medical histories of a patient and the patient’s family members for purposes of a genetic assessment; (ii) Discussing the features, natural history, means of diagnosis, genetic and environmental factors, and management of risk for genetic or medical conditions or diseases. (iii) Identifying, ordering, and coordinating genetic laboratory tests and other diagnostic studies, as appropriate, for purposes of a genetic assessment; (iv) Using the medical histories obtained from the patient and the patient’s family members for purposes of a genetic assessment; (v) Explaining the clinical implications of genetic laboratory tests and other diagnostic studies and the results of the tests and studies and communicating the risk factors for genetic or medical conditions or diseases identified by a genetic assessment; (vi) Evaluating the responses of a patient and the patient’s family members to the results of a genetic assessment and providing counseling and anticipatory guidance for a genetic or medical condition or disease; (vii) Identifying and using community resources that provide medical, educational, financial, and psychosocial support and advocacy for a genetic or medical condition or disease; and (viii) Providing written documentation of medical, genetic, and counseling information for a patient, a patient’s family members, or appropriate health care professionals. (b) “Practice genetic counseling” does not include diagnosing or treating an illness, a disease, or a condition. (15) “Qualified supervisor” means: (a) A licensed genetic counselor who has practiced for a minimum of 3 years after passing the national certifying examination; or (b) A physician who has been licensed in the State for a minimum of 5 years. (16) “Supervised genetic counselor” means an individual who is licensed by the Board, in accordance with Health Occupations Article §14-5G-14, to practice genetic counseling under the supervision of a qualified supervisor. (17) “Supervision” means the ongoing, direct, clinical review for the purposes of training or teaching by a qualified supervisor who monitors the performance of a supervised genetic counselor’s supervised interaction with a patient and provides consultations, chart reviews, guidance, and instructions with respect to the clinical skills and competencies of the supervised genetic counselor, as well as documented face-to-face meetings on at least a monthly basis. (18) “Supervised interaction” means an interaction between a supervised genetic counselor and a patient where a qualified supervisor is immediately available. #### Regulation .04 Genetic Counseling Advisory Committee. *COMAR 10.32.24.04* A. The Board shall appoint members of the Committee as follows: (1) Three individuals who practice genetic counseling who: (a) Are in good standing with the Board; (b) Are a resident of the State with at least 1 year of active genetic counseling experience as a licensed, supervised, or certified genetic counselor within the 5-year period immediately preceding the date of the appointment; and (c) On or after January 1, 2024, are licensed genetic counselors; (2) Three practicing licensed physicians who: (a) Are in good standing with the Board; and (b) Have experience working with genetic counselors; and (3) One consumer member who: (a) Shall be a member of the general public; and (b) May not: (i) Practice, or ever have practiced genetic counseling, or any other health care profession; (ii) Be, or ever have been, in training to practice genetic counseling or any other health care profession; (iii) Have a household member who is a health care professional or is in training to be a health care professional; (iv) Participate, or ever have participated, in a commercial or professional field related to genetic counseling; (v) Have a household member who participates in a commercial or professional field related to genetic counseling; (vi) Have had, within 2 years before appointment, a financial interest in a person regulated by the Board; or (vii) Have had, within 2 years of appointment, a financial interest in the provision of goods or services to genetic counselors or to the field of genetic counseling. B. Tenure. (1) The term of a member is 3 years. (2) The terms of the members are staggered. (3) At the end of a term, a member continues to serve until a successor is appointed and qualifies. (4) An individual may be reappointed for a second 3-year term, but the individual may not serve more than two consecutive 3-year terms. (5) The terms of the initial members of the Committee shall expire as follows: (a) Two members in 2024; (b) Two members in 2025; and (c) Three members in 2026. C. Vacancy. (1) If a vacancy occurs, the Board shall appoint a new member to serve on the Committee. (2) The successor member shall only serve for the remainder of the term unless reappointed. D. Chair. From among its members, the Committee shall elect a chair every 2 years. E. Quorum. (1) A quorum of the Committee consists of five members. (2) Business may not be conducted at a Committee meeting unless there is a quorum. F. In addition to the powers set forth elsewhere in this chapter, the Committee may develop and make recommendations to the Board in any matters related to the regulation of the practice of genetic counseling. #### Regulation .05 Code of Ethics. *COMAR 10.32.24.05* A genetic counselor in the State shall follow The National Society of Genetic Counselors Code of Ethics. #### Regulation .06 Application for Initial Licensure as a Genetic Counselor. *COMAR 10.32.24.06* A. An applicant for a license as a licensed genetic counselor or a supervised genetic counselor shall: (1) Complete an application on a form provided by the Board; (2) Pay the required application fee set by the Board in accordance with Regulation .12 of this chapter; (3) Be 18 years old or older; (4) Be of good moral character; (5) Demonstrate spoken and written competency in English by any of the following: (a) Documentation of graduation from a recognized English-speaking high school or undergraduate school after at least 3 years of enrollment; (b) Documentation of graduation from a recognized English-speaking professional school; or (c) Documentation of receiving a grade of at least: (i) 26 on the “Speaking Section” of the Internet-based Test of English as a Foreign Language; and (ii) 79 on the total score of the Internet-based Test of English as a Foreign Language; (6) If applicable, provide documentation of licensure, certification, or registration from all states and jurisdictions where the applicant has ever held a license, certificate, or registration in any health profession; (7) Have no history of public disciplinary action taken, or pending, against any license currently or previously held or expired; and (8) Complete a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland. B. An applicant for a license as a licensed genetic counselor or a supervised genetic counselor shall submit satisfactory evidence of graduation from an accredited educational program. C. Except as provided in § D of this regulation, an applicant for a license as a licensed genetic counselor shall submit to the Board satisfactory evidence of certification by a national certifying board. D. If an applicant for a license as a licensed genetic counselor does not meet the requirement under §C of this regulation, the applicant may qualify for licensure as a licensed genetic counselor if the applicant: (1) Has worked as a genetic counselor for: (a) At least 10 years before January 1, 2024; and (b) At least 5 consecutive years immediately preceding the date on which the applicant submits the application for licensure; (2) Has graduated from an accredited educational program; (3) Submits to the Board three letters of recommendation from licensed physicians who have been licensed for at least 5 years or certified genetic counselors eligible for licensure and who: (a) Have worked with the applicant in an employment or professional setting for 3 years before the applicant submits the application for licensure; and (b) Can attest to the applicant’s competency in providing genetic counseling services. E. An applicant for a license as a supervised genetic counselor shall submit to the Board satisfactory evidence that the applicant has applied for the first available national certifying examination. F. The Board may not issue a supervised genetic counselor license to an applicant if the applicant has failed the national certifying examination two or more times. #### Regulation .07 Referral to Other Health Care Practitioners. *COMAR 10.32.24.07* If, while practicing genetic counseling, a licensed genetic counselor or supervised genetic counselor determines that a patient requires diagnosis, treatment, or management, the genetic counselor shall: A. Refer the patient to a licensed physician or another appropriate health care practitioner; and B. Document the referral in the patient’s medical record. #### Regulation .08 Scope of Practice. *COMAR 10.32.24.08* The scope of practice of a licensed genetic counselor or a supervised genetic counselor includes the following: A. Obtaining and interpreting individual or family medical and developmental histories; B. Determining the mode of inheritance and risk of transmission of genetic conditions and of birth defects, including evaluating the risks from exposure to possible mutagens and teratogens; C. Discussing the inheritance features, natural history, means of diagnosis, and management of genetic conditions and birth defects; D. Identifying, ordering, coordinating, and explaining the clinical implications of genetic laboratory tests and other diagnostic studies and their results; E. Integrating genetic laboratory test results and other diagnostic studies with personal and family medical history to assess and communicate risk factors for genetic or medical conditions and diseases; F. Assessing psychosocial factors; G. Recognizing social, educational, and cultural issues; H. Evaluating the patient’s or family’s responses to the condition or risk of recurrence and providing patient-centered counseling and anticipatory guidance; and I. Facilitating informed decision-making about testing, management, and alternatives. #### Regulation .09 Supervised Genetic Counselors. *COMAR 10.32.24.09* A. Term and Expiration. (1) A supervised genetic counselor license shall expire on the earliest of: (a) The issuance of a genetic counselor license to the supervised genetic counselor; (b) On notice of the second failure of the supervised genetic counselor to pass the certification examination; or (c) 1 year after the date of issuance. (2) A supervised genetic counselor license may not be renewed or extended beyond the 1-year expiration date. (3) A supervised genetic counselor who has not passed the certification examination within two examination cycles may not continue practicing under the supervised genetic counselor license. B. Supervision. (1) A supervised genetic counselor may practice only under the supervision of a qualified supervisor. (2) The supervised genetic counselor and the qualified supervisor shall enter into a written supervision contract that: (a) Specifies the manner of supervision; (b) Specifies any alternative qualified supervisors, as appropriate; (c) Is signed by the supervised genetic counselor and the qualified supervisor; and (d) Is maintained by both the supervised genetic counselor and the qualified supervisor and made available upon request to the Board. (3) Delegation of duties by a qualified supervisor beyond the scope of practice or failure to appropriately supervise a supervised genetic counselor may be considered unprofessional conduct in the practice of the qualified supervisor’s profession. #### Regulation .10 Renewal and Reinstatement of Licensure as a Licensed Genetic Counselor. *COMAR 10.32.24.10* A. At least 1 month before the license expires, the Board shall send a renewal notice to the licensed genetic counselor that states: (1) The date on which the current license expires; (2) The date by which the renewal application shall be received by the Board for the renewal to be issued before the license expires; and (3) The amount of the renewal fee set by the Board in accordance with Regulation .12 of this chapter. B. Renewal. (1) The Board may not renew a license until the Office of the Comptroller or the Maryland Department of Labor has verified that the individual has paid all undisputed taxes and unemployment insurance contributions, or arranged for repayment, as required by COMAR 10.31.02. (2) An individual who has been licensed by the Board as a licensed genetic counselor may renew the license every 2 years on or before the date specified by the Board by: (a) Submitting a renewal application on the form supplied by the Board; (b) Paying the required renewal fee set by the Board in accordance with Regulation .12 of this chapter; and (c) Attesting to: (i) Current certification by the national certifying board; or (ii) Completion of at least 50 hours of continuing education credits approved by the national certifying board, earned during the 2-year period preceding the expiration of the license for genetic counseling. (3) Documentation of Continuing Education. (a) A genetic counselor shall obtain documentation of attendance at continuing education and retain the documentation for 6 years. (b) The documentation shall contain, at a minimum, the following information: (i) Program title; (ii) Sponsor’s name; (iii) Genetic counselor’s name; (iv) Inclusive date or dates and location of the program; (v) The number of continuing education hours earned; and (vi) Documented verification that the genetic counselor attended the program by stamp, signature, print-out, or other official proof. (c) Proof of maintenance of certification by the national certifying board may be used to document compliance with the continuing education requirements specified in this regulation. (d) The Board may request a genetic counselor to submit evidence of having met the continuing education requirements specified in this regulation. (e) If a genetic counselor cannot demonstrate completion of the required continuing education credit hours, the Board may impose a civil penalty of up to $100 per missing continuing education credit hour. C. Reinstatement. The Board shall reinstate the license of a licensed genetic counselor who has failed to renew the license for any reason if the genetic counselor: (1) Applies for reinstatement after the date the license expires; (2) Provides documentation of current certification by the national certifying board; (3) Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland; and (4) Pays to the Board the reinstatement fee set by the Board in accordance with Regulation .12 of this chapter. D. Reinstatement of a Revoked or Surrendered License. (1) On the application of an individual whose license has been revoked or surrendered, a disciplinary panel, on the affirmative vote of a majority of the quorum, may in its discretion reinstate a revoked or surrendered license. (2) When a time period is not stated in an order for revocation or letter of surrender, the disciplinary panel may not entertain an application for post-disciplinary reinstatement until at least 3 years after the date of the order or letter of surrender. (3) A revocation of a license may not be for less than 1 year. (4) A disciplinary panel may not entertain an application for post-disciplinary reinstatement after an order of revocation unless: (a) Any time period stated in the order has expired; (b) Any condition set out in the order has been fulfilled; (c) The applicant has filed a formal application and paid the fee set by the Board in accordance with Regulation .12 of this chapter; and (d) The applicant: (i) Applies for reinstatement after the date the license expires; (ii) Provides documentation of current certification by the national certifying board; (iii) Completes a criminal history records check in accordance with Health Occupations Article, §14-308.1, Annotated Code of Maryland; (5) A disciplinary panel shall entertain applications for reinstatement pursuant to the procedures and standards of COMAR 10.32.02.06B. (6) A disciplinary panel may not entertain applications for reinstatement if a revocation or surrender is permanent. #### Regulation .11 Change in Name or Address. *COMAR 10.32.24.11* A. A licensed genetic counselor or supervised genetic counselor shall notify the Board in writing of a change of name or address within 60 days after the change. B. If a licensed genetic counselor or supervised genetic counselor fails to notify the Board within the time required under §A of this regulation, the licensed genetic counselor or supervised genetic counselor may be subject to an administrative penalty of $100. #### Regulation .12 Fees. *COMAR 10.32.24.12* The following fees are applicable to licensed genetic counselors and supervised genetic counselors: A. Initial licensed genetic counselor licensure fee—$300; B. Supervised genetic counselor licensure fee—$100; C. License renewal fees: (1) License renewal fee—$250; and (2) Maryland Health Care Commission fee—as determined by the Maryland Health Care Commission in accordance with COMAR 10.25.03; D. Reinstatement fee—$300; E. Written verification of license fee—$25; and F. Replacement of license fee—$25. #### Regulation .13 Prohibited Conduct. *COMAR 10.32.24.13* A. Subject to the hearing provisions set forth in Health Occupations Article, §14-405, Annotated Code of Maryland, a disciplinary panel may deny a license to any applicant, reprimand any licensee, place any licensee on probation, or suspend or revoke a license if the applicant or licensee: (1) Fraudulently or deceptively obtains or attempts to obtain a license for the applicant or licensee or for another; (2) Fraudulently or deceptively uses a license; (3) Is guilty of unprofessional or immoral conduct while practicing genetic counseling; (4) Is professionally, physically, or mentally incompetent; (5) Abandons a patient; (6) Is habitually intoxicated; (7) Is addicted to or habitually abuses any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland; (8) Provides professional services while: (a) Under the influence of alcohol; or (b) Using any narcotic or controlled dangerous substance as defined in Criminal Law Article, §5-101, Annotated Code of Maryland, or any other drug that is in excess of therapeutic amounts without valid medical indication; (9) Promotes the sale of services, drugs, devices, appliances, or goods to a patient so as to exploit the patient for financial gain; (10) Willfully makes or files a false report or record in the practice of genetic counseling; (11) Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of a report, or induces another to fail to file or record a report; (12) Breaches patient confidentiality; (13) Pays or agrees to pay any sum or provide any form of remuneration or material benefit to any person for bringing or referring a patient or accepts or agrees to accept any sum or any form of remuneration or material benefit from an individual for bringing or referring a patient; (14) Knowingly makes a misrepresentation while practicing genetic counseling; (15) Knowingly practices genetic counseling with an unauthorized individual or aids an unauthorized individual in practicing genetic counseling; (16) Knowingly delegates a genetic counseling duty to an unlicensed individual; (17) Grossly overutilizes health care services; (18) Offers, undertakes, or agrees to cure or treat disease by a secret method, treatment, or medicine; (19) Is disciplined by a licensing or disciplinary authority or is convicted or disciplined by a court of any state or country or is disciplined by any branch of the United States uniformed services or the U.S. Department of Veterans Affairs for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes; (20) Fails to meet appropriate standards for the delivery of genetic counseling services; (21) Knowingly submits false statements to collect fees for which services are not provided; (22) Has been subject to an investigation or disciplinary action by a licensing or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under the Board’s disciplinary statutes and has: (a) Surrendered the license, if any, issued by the state or country; or (b) Allowed the license, if any, issued by the state or country to expire or lapse; (23) Knowingly fails to report suspected child abuse in violation of Family Law Article, §5-704, Annotated Code of Maryland; (24) Practices or attempts to practice beyond their authorized scope of practice; (25) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the licensee is licensed and qualified to render because the individual is HIV positive; (26) Practices or attempts to practice genetic counseling procedures or uses or attempts to use genetic assessments if the applicant or licensee has not received education and training in the performance of the procedure or the use of the genetic assessment; (27) Fails to cooperate with a lawful investigation of the Board or a disciplinary panel; (28) Fails to complete a criminal history records check under Health Occupations Article, §14-308.1, Annotated Code of Maryland; or (29) Violates any provision of this title or any rule or regulation pertaining to genetic counseling that is adopted by the Board, the State, or the federal government. B. Crimes of Moral Turpitude. (1) Proceedings for crimes of moral turpitude under Health Occupations Article, §14-5G-18(c), Annotated Code of Maryland, shall be held in accordance with COMAR 10.32.02.07. (2) On the filing of certified docket entries with the Board by the Office of the Attorney General, the Board shall order the suspension of a license if the licensee is convicted of, or pleads guilty or nolo contendere with respect to, a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside. (3) After completion of the appellate process, if the conviction has not been reversed or the plea has not been set aside with respect to a crime involving moral turpitude, the Board shall order the revocation of a license on the certification by the Office of the Attorney General. #### Regulation .14 Required Reports. *COMAR 10.32.24.14* A. Except as provided in §B, C, or F of this regulation, hospitals, related institutions, alternative health systems as defined in Health Occupations Article, §1-401, Annotated Code of Maryland, and employers shall file with the Board a report that the hospital, related institution, alternative health system, or employer limited, reduced, otherwise changed, or terminated any licensed genetic counselor or supervised genetic counselor for any reason that might be grounds for disciplinary action under Health Occupations Article, §14-5G-18, Annotated Code of Maryland, or any regulation in this chapter. B. If the action taken by a hospital, related institution, alternative health system, or employer under §A of this regulation relates to alcohol or drug impairment, the hospital, related institution, alternative health system, or employer is not required to report the licensed genetic counselor or supervised genetic counselor to the Board if: (1) The hospital, related institution, alternative health system, or employer knows that the licensed genetic counselor or supervised genetic counselor is: (a) In an alcohol or drug treatment program that is accredited by the Joint Commission or is certified by the Maryland Department of Health; or (b) Under the care of a health care practitioner who is competent and capable of dealing with alcoholism and drug abuse; (2) The hospital, related institution, alternative health system, or employer is able to verify that the licensed genetic counselor or supervised genetic counselor remains in the treatment program until discharge; and (3) The action or condition of the licensed genetic counselor or supervised genetic counselor has not caused injury to an individual while the genetic counselor is practicing genetic counseling. C. If a licensed genetic counselor or supervised genetic counselor enters, or is considering entering, an alcohol or drug treatment program that is accredited by the Joint Commission or that is certified by the Maryland Department of Health, the licensed genetic counselor or supervised genetic counselor shall notify the hospital, related institution, alternative health system, or employer of the licensed genetic counselor or supervised genetic counselor’s decision to enter the treatment program. D. If the licensed genetic counselor or supervised genetic counselor fails to provide the notice required under §C of this regulation, and the hospital, related institution, alternative health system, or employer learns that the licensed genetic counselor or supervised genetic counselor has entered a treatment program, the hospital, related institution, alternative health system, or employer shall report to the Board that the licensed genetic counselor or supervised genetic counselor has entered a treatment program and has failed to provide the required notice. E. Noncompliance. (1) If the licensed genetic counselor or supervised genetic counselor is found to be noncompliant with the treatment program’s policies and procedures while in the treatment program, the treatment program shall notify the hospital, related institution, alternative health system, or employer of the licensed genetic counselor or supervised genetic counselor’s noncompliance. (2) On receipt of the notification required under §E(1) of this regulation, the hospital, related institution, alternative health system, or employer of the licensed genetic counselor or supervised genetic counselor shall report the licensed genetic counselor or supervised genetic counselor’s noncompliance to the Board. F. An individual is not required under this regulation to make any report that would be in violation of any federal or State law, rule, or regulation concerning the confidentiality of alcohol and drug abuse patient records. G. The hospital, related institution, alternative health system, or employer shall submit a required report within 10 days of any action described in this regulation. H. A report made under this regulation is not subject to subpoena or discovery in a civil action other than a proceeding arising out of a hearing and decision of the Board under Health Occupations Article, Title 14, Annotated Code of Maryland. #### Regulation .15 Penalties, Fines, and Sanctioning Guidelines. *COMAR 10.32.24.15* A. An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5G, Annotated Code of Maryland, is guilty of a misdemeanor and on conviction is subject to a fine not exceeding $1,000 or imprisonment not exceeding 1 year, or both. B. An individual who violates any provision of Health Occupations Article, Title 14, Subtitle 5G, Annotated Code of Maryland, or any regulation in this chapter, is subject to a civil fine of not more than $5,000 to be levied by a disciplinary panel. C. The Board shall pay any penalty collected under §A or B of this regulation into the Board of Physicians Fund. D. Failure to Make a Required Report. (1) A disciplinary panel may impose a fine up to $1,000 for a hospital, related institution, alternative health system, or employer who fails to make a report to the Board required by Regulation .14 of this chapter. (2) The Board shall deposit any funds collected under §D(1) of this regulation into the State’s General Fund. E. General Application of Sanctioning Guidelines. (1) §§ E and F of this regulation and Regulation .16 of this chapter do not apply to offenses for which a mandatory sanction is set by statute or regulation. (2) Except as provided in §F of this regulation, for violations of the sections of the Maryland Genetic Counseling Act listed in the sanctioning guidelines, a disciplinary panel may not impose a sanction less severe than the minimum listed in the sanctioning guidelines or more severe than the maximum listed in the sanctioning guidelines for each offense. (3) Ranking of Sanctions. (a) For the purposes of this regulation, the severity of sanctions is ranked as follows, from the least severe to the most severe: (i) Reprimand; (ii) Probation; (iii) Suspension; and (iv) Revocation. (b) A stayed suspension in which the stay is conditioned on the completion of certain requirements is ranked as probation. (c) A stayed suspension which does not meet the criteria for § E(3)(b) of this regulation is ranked as a reprimand. (4) A disciplinary panel may impose more than one sanction, provided that the most severe sanction neither exceeds the maximum nor is less than the minimum sanction permitted in the sanctioning guidelines. (5) Any sanction may be accompanied by conditions reasonably related to the offense or to the rehabilitation of the offender. The inclusion of conditions does not change the ranking of the sanction. (6) If a licensee has violated more than one ground for discipline as set out in the sanctioning guidelines: (a) The sanction with the highest severity ranking shall be used to determine which ground will be used in developing a sanction; and (b) A disciplinary panel may impose concurrent sanctions based on other grounds violated. (7) Notwithstanding the sanctioning guidelines set forth in Regulation .16 of this chapter, in order to resolve a pending disciplinary action, a disciplinary panel and the licensee may agree to a surrender of license or a consent order with terms and sanction agreed to by a disciplinary panel, the administrative prosecutor, and the licensee. (8) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, a disciplinary panel may consider the aggravating and mitigating factors set forth in § F(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (9) If a disciplinary panel imposes a sanction that departs from the sanctioning guidelines as set forth in Regulation .16 of this chapter, the disciplinary panel shall state the reasons for doing so in its final decision and order. F. Aggravating and Mitigating Factors. (1) Depending on the facts and circumstances of each case, and to the extent that the facts and circumstances apply, a disciplinary panel may consider the aggravating and mitigating factors set out in § F(4) and (5) of this regulation and may in its discretion determine, based on those factors, that an exception should be made and that the sanction in a particular case should fall outside the range of sanctions listed in the sanctioning guidelines. (2) Nothing in this regulation requires a disciplinary panel or an Administrative Law Judge to make findings of fact with respect to any of these factors. (3) The existence of one or more of these factors does not impose on a disciplinary panel or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set out in the sanctioning guidelines. (4) Mitigating factors may include, but are not limited to, the following: (a) The absence of a prior disciplinary record; (b) The offender self-reported the incident; (c) The offender voluntarily admitted the misconduct, made full disclosure to the Board, and was cooperative during the Board proceedings; (d) The offender implemented remedial measures to correct or mitigate the harm arising from the misconduct; (e) The offender made good faith efforts to make restitution or to rectify the consequences of the misconduct; (f) The offender has been rehabilitated or exhibits rehabilitative potential; (g) The misconduct was not premeditated; (h) There was no potential harm to patients or the public or other adverse impact; or (i) The incident was isolated and is not likely to recur. (5) Aggravating factors may include, but are not limited to, the following: (a) The offender has a previous criminal or administrative disciplinary history; (b) The offense was committed deliberately or with gross negligence or recklessness; (c) The offense had the potential for or actually did cause patient harm; (d) The offense was part of a pattern of detrimental conduct; (e) The offender committed a combination of factually discrete offenses adjudicated in a single action; (f) The offender pursued his or her financial gain over the patient’s welfare; (g) The patient was especially vulnerable; (h) The offender attempted to hide the error or misconduct from patients or others; (i) The offender concealed, falsified, or destroyed evidence or presented false testimony or evidence; (j) The offender did not cooperate with the investigation; or (k) Previous attempts to rehabilitate the offender were unsuccessful. (6) A departure from the sanctioning guidelines set forth in Regulation .16 of this chapter is not a ground for any hearing or appeal of a Board action. G. Offenses Related to Continuing Medical Education Credits. (1) If a licensee has submitted an application claiming the completion of continuing medical education credits and the licensee fails to document the completion of such continuing medical education credits when audited by the Board, the licensee may be charged under one or more of the following, as appropriate: (a) Health Occupations Article, §14-5G-18(a)(3), Annotated Code of Maryland; (b) Health Occupations Article, §14-5G-18(a)(10), Annotated Code of Maryland; and (c) Health Occupations Article, §14-5G-18(a)(11), Annotated Code of Maryland. (2) Upon finding a violation, a disciplinary panel may impose any discipline authorized under Health Occupations Article, §14-5G-18, Annotated Code of Maryland, and the sanctioning guidelines. H. Payment of Fines. (1) An individual shall pay to the Board any fine imposed under this regulation within 15 calendar days of the date of the order, unless the order specifies otherwise. (2) Filing an appeal under State Government Article, § 10-222, Annotated Code of Maryland, does not stay payment of a fine imposed by the Board pursuant to this regulation. (3) If an individual fails to pay, in whole or in part, a fine imposed by the Board pursuant to this regulation, the Board may not restore, reinstate, or renew a license until the fine has been paid in full. (4) In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. #### Regulation .16 Sanctioning Guidelines for Genetic Counselors. *COMAR 10.32.24.16* A. Subject to provisions of Regulation .14E and F of this chapter, a disciplinary panel may impose sanctions as outlined in §B of this regulation on genetic counselors and supervised genetic counselors for violations of Health Occupations Article, §14-5G-18, Annotated Code of Maryland. B. Range of Sanctions. ### Chapter 25 — Supervised Medical Graduates **Authority:** Health Occupations Article, §14-306, Annotated Code of Maryland **Administrative History:** Effective date: September 01, 2025 (52:17 Md. R. 874) #### Regulation .01 Scope. *COMAR 10.32.25.01* A. This chapter governs the delegation of duties by a delegating physician to a supervised medical graduate in accordance with Regulations .04 and .05 of this chapter. B. This chapter may not be construed: (1) As establishing licensure, certification, or registration by the Board for supervised medical graduates; (2) To apply to certified, registered, or licensed professionals or health occupation students acting in accordance with Health Occupations Article, Annotated Code of Maryland; and (3) To mean that this chapter overrides or is to be used in lieu of more stringent regulations, policies, and procedures established by State licensure or certification requirements or Board-recognized accrediting agencies. #### Regulation .02 Definitions. *COMAR 10.32.25.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Physicians. (2) “Delegated duty” means a routine medical or surgical act that does not require medical judgment and is performed under the supervision of a delegating physician. (3) “Delegating physician” means a physician possessing an active license to practice medicine in the State who directs a supervised medical graduate to perform delegated duties. (4) “Direct supervision” means oversight exercised by a delegating physician who is: (a) Personally treating the patient; (b) In the same medical office as the patient and the supervised medical graduate; and (c) Immediately available to provide assistance and guidance to the supervised medical graduate for the duration of the delegated duty. (5) “ECFMG” means the Educational Commission for Foreign Medical Graduates or its successor. (6) “LCME” means the Liaison Committee on Medical Education, an organization which accredits programs in medical education leading to the doctor of medicine degree in the United States and its territories and, in cooperation with the Committee on Accreditation of Canadian Medical Schools, in Canada. (7) Medical Office. (a) “Medical office” means any facility or location used for the delivery of health services. (b) “Medical office” includes but is not limited to: (i) A health care facility as defined in Health-General Article, §19-114, Annotated Code of Maryland; and (ii) An ambulatory surgical facility as defined in Health-General Article, §19-3B-01(b), Annotated Code of Maryland. (8) “Supervised medical graduate” means an individual who meets the requirements of Regulations .03 and .04 of this chapter and is delegated duties by a delegating physician in accordance with Regulation .05 of this chapter. #### Regulation .03 Qualifications. *COMAR 10.32.25.03* A supervised medical graduate shall: A. Have a degree of: (1) Doctor of Medicine from a school of medicine accredited by the LCME or its successor at the time of graduation; (2) Doctor of Osteopathy from a school of osteopathy in the United States, its territories or possessions, Puerto Rico, or Canada that has standards for graduation equivalent to those established by the American Osteopathic Association; or (3) Have a doctor of medicine degree from any other medical school and have successfully completed the requirements for and obtained ECFMG certification; and B. Receive a passing score in Part 1 and Part 2 of the United States Medical Licensing Examination. #### Regulation .04 Requirements. *COMAR 10.32.25.04* A. An individual may not practice as a supervised medical graduate for a period of more than 2 years. B. A supervised medical graduate may only be delegated duties by a delegating physician while under the direct supervision of the physician. C. A supervised medical graduate shall wear an identification badge while on the premises of the medical office that states in readily visible type: (1) The name of the supervised medical graduate; and (2) The title “Supervised Medical Graduate”. D. A supervised medical graduate shall comply with all additional requirements established by: (1) Maryland Department of the Environment; (2) The Joint Commission; and (3) Any federal or State agency, including any federal or State laws or regulations. E. A medical office employing a supervised medical graduate shall: (1) Issue the supervised medical graduate an identification badge in accordance with §C of this regulation; (2) Verify all credentials of the supervised medical graduate; (3) Maintain documentation that the supervised medical graduate meets the requirements of this chapter on the premises of the medical office; (4) Permit the Board to inspect the maintained documentation to ensure compliance with this chapter; and (5) Verify all duties delegated to and performed by the supervised medical graduate are in accordance with Health Occupations Article, §14-306, Annotated Code of Maryland, and this chapter. #### Regulation .05 Scope of Delegation to a Supervised Medical Graduate. *COMAR 10.32.25.05* A. A delegating physician may delegate duties consistent with national standards in the medical community and the approved policies and procedures of the medical office. B. A delegating physician is not required to be in the presence of a supervised medical graduate and the patient during the duration of the performance of delegated duties. C. A delegating physician may delegate duties to a supervised medical graduate only while physically on the premises of the same medical office as the supervised medical graduate. #### Regulation .06 Prohibited Conduct. *COMAR 10.32.25.06* A. A supervised medical graduate acting beyond the scope of this chapter may be: (1) Considered to be engaged in the unlicensed practice of medicine; and (2) Subject to all applicable penalties and fines in accordance with Health Occupations Article, §§14-601,14-602, 14-606 Annotated Code of Maryland and COMAR 10.32.02. B. A delegating physician, through either act or omission, facilitation, or otherwise enabling or forcing a supervised medical graduate to practice beyond the scope of this chapter, may be subject to discipline for grounds within Health Occupations Article, §14-404(a), Annotated Code of Maryland including, but not limited to, practicing medicine with an unauthorized person or aiding an unauthorized person in the practice of medicine. C. A delegating physician may not: (1) Require a supervised medical graduate to perform delegated duties; or (2) Permit a supervised medical graduate to delegate duties to another individual. #### Regulation .07 Enforcement. *COMAR 10.32.25.07* The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, §14-306, Annotated Code of Maryland and this chapter. ## Subtitle 33 — Board of Long-Term Care Administrators ### Chapter 01 — General Regulations **Authority:** Health-General Article, §2-104; Health Occupations Article, §§9-101—9-501; Annotated Code of Maryland **Administrative History:** Effective date: July 15, 1971 **Administrative History:** Regulations .01, .02, .06, .08, .10A, .13, .14, .15, .16, and .24 amended effective January 22, 1975 (2:2 Md. R. 86) **Administrative History:** Regulations .01—.24 repealed effective December 15, 1986 (13:25 Md. R. 2260) **Administrative History:** Annotation: COMAR 10.33.01.07 cited in Attorney General Opinion No. 85-030 (December 13, 1985) **Administrative History:** Regulations .01—.22 adopted effective December 15, 1986 (13:25 Md. R. 2660) **Administrative History:** Regulation .02 amended effective April 1, 2002 (29:6 Md. R. 567) **Administrative History:** Regulation .02B amended effective January 25, 2010 (37:2 Md. R. 68); March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulation .02D amended effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .03A and C amended effective April 27, 1992 (19:8 Md. R. 804) **Administrative History:** Regulation .04 amended effective January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .05B amended effective May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376) **Administrative History:** Regulation .05C, E amended effective May 23, 1994 (21:10 Md. R. 844) **Administrative History:** Regulation .05D, F amended effective January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .06 amended effective April 27, 1992 (19:8 Md. R. 804); January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .06C amended effective May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376) **Administrative History:** Regulation .06E amended effective September 23, 1996 (23:19 Md. R. 1376) **Administrative History:** Regulation .07 amended effective May 23, 1994 (21:10 Md. R. 844); April 1, 2002 (29:6 Md. R. 567) **Administrative History:** Regulation .07D amended effective January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .07D-1 adopted effective January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .07E amended effective March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulation .07F, G amended effective April 27, 1992 (19:8 Md. R. 804) **Administrative History:** Regulation .08 amended effective April 1, 2002 (29:6 Md. R. 567) **Administrative History:** Regulation .08D amended as an emergency provision effective November 3, 2005 (32:25 Md. R. 1938); amended permanently effective February 27, 2006 (33:4 Md. R. 352) **Administrative History:** Regulation .08D amended effective January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .08E amended effective April 27, 1992 (19:8 Md. R. 804); May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376) **Administrative History:** Regulation .08E amended as an emergency provision effective November 17, 1999 (26:25 Md. R. 1896); amended permanently effective March 20, 2000 (27:5 Md. R. 584) **Administrative History:** Regulation .09 amended effective January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .10C amended effective April 27, 1992 (19:8 Md. R. 804); May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376); January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .11A amended effective April 27, 1992 (19:8 Md. R. 804) **Administrative History:** Regulation .12 amended effective May 23, 1994 (21:10 Md. R. 844); April 1, 2002 (29:6 Md. R. 567); January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .12A—C amended effective April 27, 1992 (19:8 Md. R. 804) **Administrative History:** Regulation .12B, C amended effective March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulation .13 amended effective April 27, 1992 (19:8 Md. R. 804); April 1, 2002 (29:6 Md. R. 567); January 25, 2010 (37:2 Md. R. 68); March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulation .13D amended as an emergency provision effective February 22, 1996 (23:6 Md. R. 472); amended permanently effective June 17, 1996 (23:12 Md. R. 871) **Administrative History:** Regulation .13F amended effective May 23, 1994 (21:10 Md. R. 844); September 23, 1996 (23:19 Md. R. 1376); June 28, 1999 (26:13 Md. R. 1019) **Administrative History:** Regulation .14 amended effective May 23, 1994 (21:10 Md. R. 844); January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .14B amended effective April 27, 1992 (19:8 Md. R. 804); March 20, 2000 (27:5 Md. R. 584); March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulation .14C amended effective April 27, 1992 (19:8 Md. R. 804) **Administrative History:** Regulation .15A amended effective October 4, 1999 (26:20 Md. R. 1546); January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .17D amended effective December 13, 1999 (26:25 Md. R. 1898) **Administrative History:** Regulation .17E amended effective April 27, 1992 (19:8 Md. R. 804); April 1, 2002 (29:6 Md. R. 567); January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Regulation .17F amended effective April 27, 1992 (19:8 Md. R. 804) **Administrative History:** Regulation .17-1 adopted effective April 1, 2002 (29:6 Md. R. 567) **Administrative History:** Regulation .18C amended effective January 25, 2010 (37:2 Md. R. 68) **Administrative History:** Chapter revised effective March 19, 2012 (39:5 Md. R. 383) **Administrative History:** Regulation .03A amended effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .08D amended effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .13A amended effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .13F amended effective May 20, 2019 (46:10 Md. R. 489) **Administrative History:** Regulation .14A amended effective February 27, 2017 (44:4 Md. R. 254) **Administrative History:** Regulation .16E amended effective May 20, 2019 (46:10 Md. R. 489) **Administrative History:** Regulations .01 — .29 under COMAR 10.33.01 Nursing Home Administrators, under Subtitle 10.33 Board of Nursing Home Administrators, repealed effective January 19, 2026 (53:1 Md. R 22) **Administrative History:** Regulations .01 — .04 under COMAR 10.33.01 Nursing Home Administrators, under Subtitle 10.33 Board of Long-Term Care Administrators, adopted effective January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Scope. *COMAR 10.33.01.01* This subtitle governs the licensure, practice, and discipline of nursing home administrators and assisted living managers in the State. #### Regulation .02 Definitions. *COMAR 10.33.01.02* A. In this subtitle, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrator-in-training (AIT)” means an applicant approved by the Board to train to practice as a nursing home administrator in a nursing home under the supervision of a preceptor pursuant to this subtitle. (2) “Administrator-in-training (AIT) contract” means a document signed by an AIT and a preceptor which includes requirements of the AIT program. (3) “Administrator-in-training (AIT) program” means a Board-approved program which consists of practical training and experience in nursing home administration. (4) “Alternate assisted living manager” means an individual who is available to assume the duties of the licensed assisted living manager for a licensed assisted living program when the licensed assisted living manager is temporarily unavailable to perform the duties of an assisted living manager. (5) “Assisted living manager” means an individual who is: (a) Designated by an assisted living program to oversee the overall day-to-day operations of an assisted living program; and (b) Responsible for the duties set forth under COMAR 10.07.14.15. (6) Assisted Living Program. (a) “Assisted living program” means a residential or facility-based program for two or more residents that provides long-term housing and supportive services, supervision, personalized assistance, health-related services, or a combination of those that meets the needs of the individuals who are unable to perform or who need assistance in performing the activities of daily living or instrumental activities of daily living in a way that promotes optimum dignity and independence for the individuals. (b) “Assisted living program” does not include: (i) A nursing home as defined by Health-General Article, §19-1401, Annotated Code of Maryland; (ii) A nursing facility as defined by Health-General Article, §19-301, Annotated Code of Maryland; (iii) A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland; (iv) A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland; (v) A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland; (vi) Services provided by family members; (vii) Services provided by a licensed residential service agency or licensed home health agency in an individual’s own home; or (viii) A Certified Adult Residential Environment Program that is certified by the Department of Human Services under Human Services Article, §§6-508—6-513, Annotated Code of Maryland. (7) “Board” means the State Board of Long-Term Care Administrators. (8) “Central Repository” means the Criminal Justice Information System Central Repository of the Maryland Department of Public Safety and Correctional Services. (9) “Department” means the Maryland Department of Health. (10) “Endorsement applicant” means an individual applying for a license to practice nursing home administration in the State who is licensed in another state to practice nursing home administration. (11) “Family” means: (a) A spouse; (b) A child; (c) A sibling; (d) A parent; (e) A grandparent; (f) A niece or nephew; or (g) An uncle or aunt. (12) “Family-owned or family-operated nursing facility” means a nursing home owned or operated by any one or more of the following relatives of the AIT: (a) A spouse; (b) A parent; (c) A child; (d) A sibling; (e) A grandparent; (f) A grandchild; (g) A stepparent; (h) A stepchild; (i) An uncle or aunt; (j) A first cousin; (k) A nephew or niece; (l) A father-in-law or mother-in law; (m) A son-in-law or daughter-in-law; or (n) A brother-in-law or sister-in-law. (13) “License” means, unless the context requires otherwise, official authorization issued by the Board to practice as: (a) A nursing home administrator under Health Occupations Article, Title 9, Subtitle 3, Annotated Code of Maryland; or (b) An assisted living manager under Health Occupations Article, Title 9, Subtitle 3A, Annotated Code of Maryland. (14) “Licensee” means, unless the context requires otherwise, an individual licensed by the Board to practice as: (a) A nursing home administrator; or (b) An assisted living manager. (15) “National Association of Long Term Care Administrator Boards (NAB)” means the organization that commissions the services of a third-party administrator of the State and national examinations for long term care administrators. (16) “Nursing home” means a facility or institution as defined in Health Occupations Article, §9-101(i), Annotated Code of Maryland, and includes: (a) A comprehensive care facility or extended care facility which offers non-acute inpatient care to residents who: (i) Have a disease, chronic illness, condition, disability of advanced age, or terminal disease requiring maximal nursing care without continuous hospital services; and (ii) Require medical services and nursing services rendered by or under the supervision of a licensed nurse together with convalescent, restorative, or rehabilitative services; and (b) A nursing facility as defined under federal or State law. (17) “Nursing home administrator” means an individual licensed by the Board, who: (a) Administers, directs, manages, supervises, or is in general administrative charge of a nursing home, whether or not the individual has an ownership interest in the facility, and whether or not the individual's functions and duties are shared with one or more individuals; or (b) Is in supervisory control over one or more nursing home administrators of one or more nursing homes and has authority to substitute the supervisor's judgment for that of the administrator of record in the day-to-day operation of the facility. (18) “Person” means any individual, guardian, personal representative, company, corporation, partnership, limited liability company, association, representative of any kind, or non-governmental entity. (19) “Practice of assisted living management” means the exercise of final authority of any act or in the making of any decision involved in the planning, organizing, directing, or controlling of the day-to-day operation of an assisted living program. (20) “Practice of nursing home administration” means the exercise of final authority of any act or in the making of any decision involved in the planning, organizing, directing, or controlling of the day-to-day operation of a nursing home. (21) “Preceptor” means an individual certified to serve as an instructor in an AIT program to be a nursing home administrator, pursuant to this subtitle. (22) “State standards exam” means an examination developed by the Board based on the following chapters: (a) COMAR 10.07.02; (b) COMAR 10.07.09; (c) COMAR 10.09.10; (d) COMAR 10.09.24; and (e) COMAR 10.15.03. #### Regulation .03 General Powers of the Board. *COMAR 10.33.01.03* A. The Board shall exercise the powers provided by the laws of this State pertaining to the licensure, practice, and discipline of nursing home administrators and assisted living managers. B. Board staff and designees of the Board: (1) May enter any nursing home and assisted living program in the State in order to carry out its functions; and (2) Shall have access to the records related to licensure of any nursing home and assisted living program in the State in order to carry out its functions. C. The Office of Health Care Quality may assist the Board in carrying out its functions. D. The Board has the authority to utilize consultant experts, as needed, in areas of its concern. E. From time to time, the Board shall make and publish regulations for the execution and enforcement of the laws related to the licensure, license renewal, and discipline of nursing home administrators and assisted living managers. #### Regulation .04 Severability. *COMAR 10.33.01.04* If any provision of the regulations in this subtitle is declared unconstitutional or invalid, or the application of these regulations to any person or circumstances is held invalid, the applicability of the provision to other persons and circumstances and the constitutionality or validity of every other provision of these regulations is not to be affected. ### Chapter 02 — Licensing of Nursing Home Administrators **Authority:** Health Occupations Article, §§9-205, 9-301—9-316.1, and 9-401—9-501, Annotated Code of Maryland **Administrative History:** Effective date: January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Scope. *COMAR 10.33.02.01* This chapter governs nursing home administrator applicants and licensees in the State pursuant to Health Occupations Article, Title 9, Annotated Code of Maryland. #### Regulation .02 Licensure Qualifications, Applications, and Requirements. *COMAR 10.33.02.02* A. Except as otherwise provided by law, to qualify for an initial license to practice nursing home administration in the State, the applicant shall: (1) Be at least 21 years old; (2) Be of good moral character; (3) Submit to a State and national criminal history records check in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland; (4) Obtain a passing score on the State standards exam; (5) Obtain a passing score on the national licensure exams provided by NAB; and (6) Except for an endorsement applicant, successfully complete the AIT program as set forth in Regulation .04 of this chapter. B. The Board’s receipt of the State and national criminal history records check from the Central Repository, as provided in Health Occupations Article, §9-302.1(c), Annotated Code of Maryland, satisfies Health Occupations Article, §9-303(3), Annotated Code of Maryland. C. The applicant shall submit to the Board: (1) The completed Board online application; (2) The application fee as set forth under COMAR 10.33.05.02D; (3) Satisfactory evidence that the applicant has a bachelor’s or master’s degree in: (a) Healthcare, health administration, or healthcare management, or the equivalent, with a concentration in healthcare administration or health administration or a master’s degree in business with a concentration in healthcare administration or health administration from an accredited college or university; or (b) A field other than as described in §C(3)(a) of this regulation and has completed within the last 5 years a minimum 100-hour course approved by the Board in healthcare administration or health administration; (4) Two letters of character reference, which are signed and dated within 3 months prior to the date of application, from individuals engaged in either business or professional work on company or business letterhead: (a) Who shall attest to the good moral character of the applicant; and (b) Which may not be those from current employers or members of the applicant's family; and (5) A passport type and size photograph of the applicant, which shall have been taken within 3 months prior to the date of application. D. Except for an endorsement applicant, an applicant may take the State standards exam and NAB exams when the applicant has completed: (1) A minimum of 8 months of the full-time 12-month AIT program or its equivalent or 12 months of the 18-month part-time AIT program or its equivalent; and (2) The other requirements for licensure as specified in this regulation. E. The 100-hour course for applicants with a bachelor’s or master’s degree in a field other than those described in §C(3)(a) of this regulation shall: (1) Contain the subject matter relating to healthcare or health administration set forth under Regulation .03A of this chapter; and (2) Be taken for credit for the purpose of initial licensure and be a course that has been approved by the Board. F. An applicant who provides satisfactory evidence to the Board that the applicant is a registered nurse and who meets the requirements of Health Occupations Article, §9-302(f)(1), Annotated Code of Maryland, is not required to have a bachelor’s or master’s degree. G. An application shall be void if an applicant fails to meet all the requirements for licensure within 2 years of receipt of the application by the Board. To pursue licensure after that time, the applicant shall: (1) Submit a new application; and (2) Meet the requirements for licensure that are in effect at the time of reapplication. #### Regulation .03 Examinations for Nursing Home Administrators. *COMAR 10.33.02.03* A. Subjects for Examination. The State standards exam and the NAB exams shall include, at a minimum, the following subjects: (1) Applicable standards of environmental health and safety; (2) Local health and safety regulations; (3) General administration; (4) Psychology of patient care; (5) Principles of medical care; (6) Personal and social care; (7) Therapeutic and supportive care and services in long-term care; (8) Departmental organization and management; and (9) Community interrelationships. B. Scoring Examinations. (1) The passing score for licensure examinations for a license shall be determined by the Board. (2) The Board shall determine a method of scoring each part of the exams separately and shall apply that method uniformly to all applicants taking the exams. (3) Minimum Passing Scores. The following apply. (a) The NAB national exams—scale score of 113 on the: (i) NAB CORE exam; and (ii) NAB NHA exam; and (b) The State standards exam—75 percent correct answers. #### Regulation .04 Administrator-in-Training Program—Requirements for AIT Participation. *COMAR 10.33.02.04* A. General Provisions. (1) An AIT program is a supervised 12-month full-time, or 18-month part-time, internship during which the AIT works under the guidance and supervision of a preceptor who is a licensed administrator that meets the qualifications set forth in Regulations .05 and .06 of this chapter. (2) The AIT program is a required phase of education consisting of both the supervised practice of nursing home administration in the environment of the nursing home, performing and participating in the day-to-day duties of each position, when legally permissible, in each of the following service areas: (a) Administration; (b) Business office; (c) Nursing; (d) Resident activities; (e) Social services; (f) Medical records; (g) Dietary services; (h) Maintenance; (i) Environmental services, including housekeeping and laundry; (j) Rehabilitation services; and (k) Quality assurance. (3) Prior to Board approval of the AIT program, the AIT applicant and preceptor shall develop an outline for the written course of instruction and dates of rotation schedule for the provision of practical training, experience, and learning situations that includes: (a) The 11 basic service areas set forth in §A(2) of this regulation; (b) The AIT's past experience and allocation of clinical experiences in the nursing home; and (c) Approval by the Board. (4) An AIT may not, during the normal working hours of the program, fill a specific, specialized position in the nursing home. (5) The AIT shall be exposed to all shifts during the AIT program. (6) If the AIT is a department head, notice shall be conspicuously posted in the nursing home stating who the acting department head will be while the AIT is performing training duties. (7) If an applicant does not meet all of the requirements for licensure after having completed 12 months in the full-time or 18 months in the part-time AIT program, the preceptor and applicant have the option to work out a plan satisfactory to the Board to continue studying in the AIT program beyond the 12 or 18 months until all the requirements are met. (8) The Board or Board committee shall interview each applicant and proposed preceptor, or preceptors, before the approval of an AIT program. (9) After the interview, the AIT and preceptor shall sign an AIT contract and submit it to the Board for consideration of approval. (10) The Board may approve the AIT program if it is satisfied that the background and circumstances of the applicant and preceptor, or preceptors, qualify them for the AIT program. (11) A change of preceptor may be authorized by the Board upon submission of: (a) Application by the proposed new preceptor; (b) Evidence satisfactory to the Board that the proposed preceptor is certified by the Board; and (c) A new signed AIT contract by the AIT and preceptor. (12) If a preceptor is found by the Board to have failed to provide adequate training, the Board may cancel the preceptor's authorization to serve as a preceptor for a period of time prescribed by the Board. (13) The AIT and preceptor shall comply with the AIT contract. (14) An individual duly registered as an AIT whose internship is interrupted by service in the armed forces of the United States shall be permitted to resume the internship without loss of credit at any time within 1 year after the date of the AIT's separation from active service. B. Application Requirements. (1) The Board may approve an application for a nursing home AIT program only if it determines that the application contains satisfactory evidence that: (a) The applicant is at least 21 years old; (b) The applicant is of good moral character; (c) The applicant's training will be supervised by a Board-certified preceptor; and (d) The AIT program meets the other requirements set forth in this regulation. (2) The training proposed to be provided to the applicant shall be satisfactory to the Board. (3) The applicant shall participate in training provided in: (a) A nursing home licensed in the State, as defined in COMAR 10.33.01.02B; and (b) Not more than two licensed nursing homes in the State approved by the Board for training. If two nursing homes are utilized for training, one shall have at least 60 beds. (4) If there are subject areas as specified in the list of subjects provided in §A(2) of this regulation that are not available in the nursing home approved by the Board for training, the Board may require training in other facilities. C. Credit for Prior Experience. (1) The AIT program is a minimum of 12 months for full-time programs or 18 months for part-time programs unless, upon request from the applicant to review prior work experience, the Board awards credit for prior experience within the last 5 years. The amount of credit awarded is at the discretion of the Board, based on an applicant’s work experience demonstrating exposure to the core of knowledge set forth in Regulation .04A(2) of this chapter, but may not exceed; (a) Six months for a hospital assistant administrator; (b) Eight months for a hospital administrator; (c) Six months for a nursing home assistant administrator; (d) Six months for a department head; (e) Three months for an Executive Director of a continuing care retirement community; (f) Three months for an assisted living manager; (g) Three months for a healthcare-related senior management official; or (h) Three months for a non-healthcare-related senior management official. (2) Qualifying Experience for Healthcare Related Professions in §C(1)(a)—(f) of this regulation. The minimum experience required for receiving credit towards the AIT program includes: (a) A minimum of 18 months as a full-time employee, with line responsibility for hiring, firing, budget, and supervision of at least one department comprised of ten or more employees; and (b) Reporting directly to the nursing home administrator or chief executive officer. (3) Qualifying Experience for Healthcare Related or Non-Healthcare Related Senior Management Official in §C(1)(g) and (h) of this regulation. The following requirements set the minimum experience required for receiving credit: (a) Minimum of 18 months as a full-time senior management official of a single nursing home or entity; and (b) Administrative responsibility for the total operation of the nursing home or entity and its multiple departments, as applicable. (4) Experience credit can be awarded on a month-to-month basis totaling 12 months for: (a) An individual who has worked as a licensed nursing home administrator in another state; (b) A resident or intern in a program offered by an accredited college or university for the purpose of satisfying the requirements for a baccalaureate or master's degree in healthcare administration; or (c) An individual who has successfully completed an AIT program in another state, if the program is substantially comparable to the AIT program in the State, as determined by the Board. #### Regulation .05 Requirements for AIT Program. *COMAR 10.33.02.05* A. The preceptor for an AIT shall be currently certified by the Board under Regulation .06 of this chapter. B. The preceptor may not be responsible for more than two AITs at any one time. The preceptor shall devote a minimum of 16 hours per week of direct, on-site supervision for each AIT, which may be on an individual or combined basis in the case of two AITs. C. The preceptor may be the administrator of record of the facility in which the training is to take place, provided that the preceptor has had a minimum of 30 days of oversight in the facility where the training is to take place immediately prior to beginning the AIT program. D. The preceptor may not be the administrator of record for a facility other than the facility designated for training. E. A minimum of 80 percent of the training shall occur during 8 consecutive hours for full-time programs or 6 consecutive hours for part-time programs each day (except for regular days off) between the hours of 7 a.m. and 7 p.m. F. A minimum of 40 hours per week for full-time or 30 hours per week for part-time shall be devoted to continuous, bona fide training activities which include observing and performing the day-to-day duties of each position, when legally permissible, in the service areas referred to in Regulation .04A(2) of this chapter. G. The applicant may spend a maximum of 50 percent of the training in a family-owned or family-operated nursing home, and the remainder of the time shall be spent in another Board-approved facility. H. An employee may not be a preceptor for their employer. I. Required AIT Reports. (1) The AIT and preceptor shall maintain a progress report for the training program on the forms provided by the Board for every 3 months of the training program. (2) The report shall: (a) Be submitted by the AIT and the preceptor to the Board's office on the dates specified by the Board; and (b) Include the following: (i) A detailed description of activity or area covered, or both, and dates of rotation, and, if applicable, an explanation for any changes to the Board-approved rotation schedule; (ii) A detailed analysis of any problems observed, new experiences, insights gained, and the AIT's role in problem solutions; and (iii) The course of instruction outline including signatures from the preceptor, AIT, and department managers to verify that the AIT trained in those departments. (3) If the reports are not submitted to the Board's office by the date specified by the Board, the AIT shall be considered to have violated the terms of the AIT contract. J. Discontinuance of AIT Status in a Nursing Home. (1) The AIT and the preceptor shall report discontinuance within 10 days to the Board. (2) Within 10 days of the date of discontinuation, the preceptor shall file a report to the Board detailing the AIT's experience and abilities. (3) The AIT may fulfill the training requirement in no more than two licensed nursing facilities, with a lapse of no more than 90 days between the two periods of training. #### Regulation .06 Certification of Preceptors. *COMAR 10.33.02.06* A. The Board shall issue a certificate of qualification to be a preceptor in the AIT program if the following conditions are met: (1) The preceptor holds and has held a license from the Board for 1 year or longer; (2) The proposed preceptor has been satisfactorily employed in nursing home administration for a minimum of 3 years as the nursing home administrator of record; (3) The proposed preceptor has no disciplinary action pending nor is currently under investigation by the Board; (4) Individuals seeking certification as preceptors in the AIT program shall submit evidence of the successful completion of the preceptor training course offered by NAB; and (5) The proposed preceptor has either been employed full time as a nursing home administrator of record for a minimum of 2 of the past 3 years immediately before application to precept or meets the following qualifications: (a) Works on the same property as the nursing home where the AIT program will be conducted; (b) Is able to demonstrate to the Board the proposed preceptor’s active, direct, and material management and daily operations of the nursing home; and (c) Has been actively licensed as a nursing home administrator for a minimum of 5 years immediately before application to precept. B. If the proposed preceptor has not precepted an AIT program within the past 5 years, the proposed preceptor shall recertify as a preceptor by completing the preceptor training course offered by NAB. C. The Board may disapprove a preceptor for a training program: (1) If the preceptor has failed to remain in compliance with this chapter; or (2) At any time for good cause. #### Regulation .07 License by Endorsement. *COMAR 10.33.02.07* A. The Board, in its discretion, may grant a license by endorsement to practice nursing home administration in the State, upon satisfactory evidence that the endorsement applicant, in addition to the requirements of this section, meets all the qualifications and requirements for a nursing home administrator license set forth in Regulation .02 of this chapter, except that the endorsement applicant is not required to: (1) Take the NAB exams set forth under Regulation .03 of this chapter; or (2) Participate in the AIT program that is set forth under Regulation .04 of this chapter. B. The endorsement applicant shall: (1) Possess a valid license as a nursing home administrator, which has not been revoked or suspended in each state from which the applicant has ever received a nursing home administrator license or reciprocal endorsement; (2) Provide satisfactory evidence of having completed one year as the full-time nursing home administrator of record in a nursing home within the last 5 years; and (3) Be familiar with State and local health and safety regulations related to nursing homes by evidence of a passing score on the State standards exam. C. To be granted a State nursing home administrator license, the endorsement applicant shall possess a nursing home administrator license in other states that shall: (1) Maintain a system and standard of qualification and examination for a license, which are substantially equivalent to those required by this State; and (2) Give similar recognition and endorsement to nursing home administrator licenses of this State. D. The Board may waive: (1) The education requirements of COMAR 10.33.02.02C(3), if the endorsement applicant provides satisfactory evidence to the Board that the endorsement applicant is licensed and has practiced as a nursing home administrator for at least 3 years in another state; and (2) The State standards examination, if the endorsement applicant provides satisfactory evidence to the Board that the endorsement applicant met the requirements of Health Occupations Article, §9-306(b), Annotated Code of Maryland. #### Regulation .08 Provisional License. *COMAR 10.33.02.08* A. As an exception to the licensure requirements in this chapter, a nursing home shall immediately appoint an individual not licensed to practice as a nursing home administrator to act as the interim nursing home administrator if: (1) A licensed nursing home administrator in the State leaves or is removed from the position as a nursing home administrator by death or other unexpected cause; and (2) A licensed nursing home administrator in the State is unavailable to fill the position. B. The departure of the licensed nursing home administrator specified under §A of this regulation is by unexpected cause if: (1) The departure occurred suddenly; (2) The departure was unforeseen; and (3) There was insufficient time for the nursing home to obtain the services of a nursing home administrator licensed in the State. C. The appointed non-licensed individual may begin acting as the interim nursing home administrator upon appointment by the nursing home. D. No later than 24 hours after the appointment of the non-licensed individual as interim nursing home administrator, under §A of this regulation, the nursing home shall: (1) File an application with the Board requesting a provisional license for the non-licensed individual; (2) Notify the Board of the circumstances involved in the departure of the licensed nursing home administrator; (3) Notify the Board of the credentials of the non-licensed individual; and (4) If requested, provide the Board with the acts the nursing home took, or is taking, to hire a nursing home administrator who is licensed in the State. E. State and National Criminal History Records Check. (1) The appointed non-licensed individual shall immediately submit to a criminal history records check, in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland. (2) A criminal history records check is not required if the appointed non-licensed individual is actively licensed by a health occupations board in the State who previously has completed a criminal history records check required for licensure, certification, or registration. (3) The Board may deny approval of an appointment based on the results of a criminal history records check after consideration of the factors listed in Health Occupations Article, §9–308(b)(1), Annotated Code of Maryland. F. Provisional License. The Board may issue a provisional license to the applicant if the Board determines that: (1) The applicant is of good moral character; (2) The departure of the licensed nursing home administrator was by unexpected cause; and (3) The applicant is capable of adequately administering the nursing home for the provisional period. G. If the Board grants the application for the provisional nursing home administrator license, the provisional license is in effect for 90 days from the date of the departure of the licensed nursing home administrator. For good cause shown, the Board may extend the provisional license period by 30 days. H. Denial of Provisional License. (1) If the application for a provisional license is denied by the Board, the nursing home may request a meeting with the Board to contest the denial. (2) The nursing home shall provide the request for a meeting to the Board within 5 business days of the denial. (3) If the nursing home requests a meeting, the appointed non-licensed individual may remain acting as the interim nursing home administrator until the Board issues a decision. (4) If the Board denies the application for a provisional license after a meeting contesting the initial denial, the non-licensed individual shall immediately cease acting as the interim nursing home administrator upon receipt of the decision. (5) If the nursing home does not file a timely request for a meeting with the Board, the non-licensed individual shall cease acting as the interim nursing home administrator within 5 business days of the denial. I. If the non-licensed individual is required to cease acting as the interim nursing home administrator under §H of this regulation, and a nursing home administrator licensed in the State remains unavailable to fill the nursing home administrator position, the nursing home may appoint another non-licensed individual as set forth in this regulation. J. As a result of §I of this regulation, if the nursing home appoints another non-licensed individual, and a provisional license is granted, the provisional license is in effect for 90 days from the date of the departure of the nursing home administrator licensed in the State, unless the Board extends the provisional license, for good cause shown, for an additional 30 days. K. Upon request by the nursing home, for reasonable cause, the Board may extend the 24-hour time period for meeting the requirements of §D of this regulation. #### Regulation .09 Renewals. *COMAR 10.33.02.09* A. The Board shall send each licensee a renewal notice that states the: (1) Date on which the current license or current registration expires; (2) Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license to be issued before the current license expires; and (3) Amount of the renewal fee as specified in COMAR 10.33.05.02D. B. At least 30 days before the current license expires, the Board shall send the renewal notice by electronic means to the last known electronic mail address or first-class mail to the physical address of the licensee. C. Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.33.04. D. Licensees shall complete an implicit bias and structural racism training program approved by the Cultural and Linguistic Health Care Professional Competency Program in accordance with Health-General Article, §20-1306, Annotated Code of Maryland, for an applicant’s first renewal after April 1, 2026. #### Regulation .10 Reinstatement After License Expiration. *COMAR 10.33.02.10* A. The Board shall reinstate an individual whose license has expired if the individual: (1) Meets the renewal requirements of this chapter and Health Occupations Article, §9-312, Annotated Code of Maryland; (2) Pays the reinstatement fee as specified under COMAR 10.33.05.02D; and (3) Satisfactorily completes the minimum continuing education requirements set forth under COMAR 10.33.04.01. B. A previously licensed nursing home administrator who fails to apply for licensure reinstatement within 5 years after the expiration date of the license shall meet the requirements for a new license in effect at the time of the request in order to be licensed to practice as a nursing home administrator in the State. #### Regulation .11 Inactive Status and Reactivation. *COMAR 10.33.02.11* A. In accordance with Health Occupations Article, §9-312.1, Annotated Code of Maryland, a request by an active licensee to transfer a license to inactive status shall be granted upon receipt of the: (1) Completed Board-approved inactive status application; and (2) Payment of the required, non-refundable, biennial inactive status fee set forth in COMAR 10.33.05.02D. B. An individual: (1) May apply for inactive status only if the individual’s license is still active at the time the inactive status application request is made; (2) Shall renew and pay the biennial inactive status fee during each renewal period; and (3) Is not authorized to and may not practice as a nursing home administrator in the State while on inactive status. C. Reactivation. (1) The Board shall reactivate the license of a licensee who is on inactive status if the licensee: (a) Completes an application form for reactivation of the license before expiration of the 2-year term of inactive status on the form required by the Board; (b) Complies with the renewal requirements in effect at the time the licensee seeks to reactivate the license; (c) Meets the continuing education requirements set by the Board; (d) Has not practiced as a nursing home administrator in the State while on inactive status; (e) Pays all appropriate fees set by the Board under COMAR 10.33.05.02D; (f) Has been on inactive status for less than 5 years; and (g) Is otherwise entitled to be licensed. (2) Before the Board may reactivate the license of an individual who has been on inactive status for 5 years or more, the individual shall: (a) Submit a new online application; (b) Pay all appropriate fees set by the Board under COMAR 10.33.05.02D; (c) Complete a 100-hour Board–approved course in healthcare administration or health administration; (d) Pass the State standards exam for nursing home administrators; and (e) Submit satisfactory evidence of having completed a State and national criminal history records check in accordance with Health Occupations Article, §9–302.1, Annotated Code of Maryland. (3) A nursing home administrator whose inactive status expires before the license is reactivated shall meet the reinstatement requirements set forth in Health Occupations Article, §9-312, Annotated Code of Maryland. #### Regulation .12 Incomplete Applications. *COMAR 10.33.02.12* A. The Board is not required to consider an application that is incomplete. B. The applicant shall submit to the Board any additional relevant documentation requested by the Board if the Board determines the application documentation received is incomplete or insufficient. C. The Board may hold an incomplete application for a license for up to 1 year from the date of receipt. D. After 1 year from the date of receipt, the Board shall close a pending application that is incomplete. E. If an application has been closed under §D of this regulation, to obtain a license the applicant shall submit a new application fee and otherwise comply with all applicable license requirements. #### Regulation .13 Display of License. *COMAR 10.33.02.13* Each individual licensed as a nursing home administrator in the State shall display printed verification of licensure in a conspicuous place in the office or place of business or employment of the licensee. #### Regulation .14 Change of Mailing Address, Legal Name, or Email Address. *COMAR 10.33.02.14* A. A licensed nursing home administrator shall give the Board written or electronic notice within 30 days of a change of: (1) Mailing address; (2) Legal name; or (3) Email address. B. Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a fine as set forth under COMAR 10.33.05.02D. ### Chapter 03 — Licensing of Assisted Living Managers **Authority:** Health-General Article, §19-1809; Health Occupations Article, §§9-205, 9-3A-01—9-3A-18, and 9-401—9-501; Annotated Code of Maryland **Administrative History:** Effective date: January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Effective Date and Scope. *COMAR 10.33.03.01* A. Except as otherwise provided in this chapter, effective July 1, 2026, an individual shall be licensed by the Board before the individual may practice as an assisted living manager in the State. B. This chapter governs assisted living managers in the State pursuant to Health Occupations Article, Title 9, Annotated Code of Maryland. #### Regulation .02 Licensure Qualifications, Applications, and Requirements—Applicant I. *COMAR 10.33.03.02* A. This regulation applies to applicants who have practiced as an assisted living manager in a licensed assisted living program in the State prior to July 1, 2026. B. Except as otherwise provided by law, to qualify for an initial license to practice assisted living management in Maryland, an applicant shall: (1) Be at least 21 years old; (2) Be of good moral character; (3) Submit the following to the Board: (a) The completed Board online application; (b) The application fee as set forth in COMAR 10.33.05.02D; and (c) A passport type and size photograph of self, which shall have been taken within 3 months prior to the date of application; (4) Meet, and attest on the application to meeting, the following requirements: (a) Has obtained a high school diploma, a high school equivalency diploma, or other appropriate education as specified under COMAR 10.07.14.15; or (b) For level 3 licensed programs, set forth under COMAR 10.07.14.05, has completed at least one of the following: (i) A 4-year, college-level degree; (ii) 2 years of experience in a healthcare related field and 1 year of experience as an assisted living program manager or alternate assisted living manager; or (iii) 2 years of experience in a healthcare related field and successful completion of an 80-hour assisted living manager training course approved by the Department; (c) Completed an 80-hour assisted living manager training course and passed the course examination as required under Health–General Article, §19–1807(a), Annotated Code of Maryland, and Health Occupations Article, §9-3A-02(a)(5)(i), Annotated Code of Maryland. (d) Submitted to a State and national criminal history records check in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland. The Board’s receipt of the State and national criminal history records check from the Central Repository, as provided in Health Occupations Article, §9-302.1(c), Annotated Code of Maryland, satisfies Health Occupations Article, §9-3A-03(3), Annotated Code of Maryland; (e) Is certified in: (i) Basic first aid taught by a first aid instructor certified by a national organization, except licensed practical nurses and registered nurses licensed in this State who are not required to attest to being certified in basic first aid; and (ii) Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization; (f) Completed training in: (i) Fire and life safety; (ii) Infection control, including standard precautions; (iii) Emergency disaster plans; and (iv) Basic food safety. C. Exemptions for the 80-Hour Training Course. Except as otherwise provided by law, an applicant is exempt from the 80-hour training course, pursuant to Health–General Article, §19–1807(d)(1), Annotated Code of Maryland, if the applicant meets, and attests to meeting, at least one of the following: (1) Is employed by an assisted living program, has enrolled in the 80-hour training course, and expects to complete the course within 6 months; (2) Has been employed as an assisted living manager in the State for 1 year prior to January 1, 2006; or (3) Is licensed as a nursing home administrator in the State. D. If an individual is licensed through the exemption in §C(1) of this regulation, the licensee shall: (1) Complete the 80-hour course, which includes passing the course examination, within 6 months of enrollment in the course, in accordance with COMAR 10.07.14.16E(1); and (2) Submit to the Board satisfactory evidence that the licensee has completed the course, within 15 days from the date the licensee was notified of their successful completion of the course. #### Regulation .03 Licensure Qualifications, Applications, and Requirements—Applicant II. *COMAR 10.33.03.03* A. This regulation applies to applicants who have not practiced as an assisted living manager in a licensed assisted living program in the State prior to July 1, 2026. B. Except as otherwise provided by law, to qualify for an initial license to practice assisted living management in the State, an applicant shall: (1) Be at least 21 years old; (2) Be of good moral character; (3) Provide satisfactory evidence to the Board that the applicant: (a) Has obtained a high school diploma, a high school equivalency diploma, or other appropriate education as specified under COMAR 10.07.14.15; or (b) For level 3 licensed programs, set forth under COMAR 10.07.14.05, has completed at least one of the following: (i) A 4-year, college-level degree; (ii) Two years of experience in a healthcare related field and 1 year of experience as an assisted living program manager or alternate assisted living manager; or (iii) Two years of experience in a healthcare related field and successful completion of an 80-hour assisted living manager training course approved by the Department; (c) Completed an 80-hour assisted living manager training course and passed the course examination as required under Health–General Article, §19–1807(a), Annotated Code of Maryland, and Health Occupations Article, §9-3A-02(a)(5)(i), Annotated Code of Maryland; (4) Submit the following to the Board: (a) The completed Board online application; (b) The application fee as set forth in COMAR 10.33.05.02D; and (c) A passport type and size photograph of self, which shall have been taken within 3 months prior to the date of application; (5) Meet, and attest on the application to meeting, the following requirements: (a) Submitted to a State and national criminal history records check in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland; and (b) Is certified in: (i) Basic first aid taught by a first aid instructor certified by a national organization, except licensed practical nurses and registered nurses licensed in this State who are not required to attest to being certified in basic first aid; and (ii) Basic cardiopulmonary resuscitation (CPR), including a hands-on component, taught by a CPR instructor certified by a nationally recognized organization; and (c) Completed training in: (i) Fire and life safety; (ii) Infection control, including standard precautions; (iii) Emergency disaster plans; and (iv) Basic food safety. C. The Board’s receipt of the State and national criminal history records check from the Central Repository, as provided in Health Occupations Article, §9-302.1(c), Annotated Code of Maryland, satisfies Health Occupations Article, §9-3A-03(3), Annotated Code of Maryland. D. The Board may require official transcripts of the educational requirements set forth in §B(3) of this regulation. E. Exemptions for the 80-Hour Training Course. Except as otherwise provided by law, an applicant is exempt from the 80-hour training course, pursuant to Health–General Article, §19–1807(d)(1), Annotated Code of Maryland, if the applicant meets, and attests to meeting, at least one of the following: (1) Is employed by an assisted living program and has enrolled in the 80-hour training course and expects to complete the course within 6 months; or (2) Is licensed as a nursing home administrator in the State. F. If an individual is licensed through the exemption in §E(1) of this regulation, the licensee shall: (1) Complete the 80-hour course, which includes passing the course examination, within 6 months of enrollment in the course, in accordance with COMAR 10.07.14.16E(1); and (2) Submit to the Board satisfactory evidence that the licensee has completed the course, within 15 days from the date the licensee was notified of their successful completion of the course. #### Regulation .04 Provisional License. *COMAR 10.33.03.04* A. As an exception to the licensure requirements in this chapter, an assisted living program shall immediately appoint an individual not licensed to practice as an assisted living manager to act as the interim assisted living manager if: (1) An assisted living manager licensed in the State leaves or is removed from the position as an assisted living manager by death or other unexpected cause; and (2) A licensed assisted living manager in the State is unavailable to fill the position. B. The alternate assisted living manager is a non-licensed individual in this regulation and may be appointed as the interim assisted living manager under §A of this regulation, but another non-licensed individual may also be appointed. C. The departure of the assisted living manager as specified in §A of this regulation, is by unexpected cause if: (1) The departure occurred suddenly; (2) The departure was unforeseen; and (3) There was insufficient time for the assisted living program to obtain the services of an assisted living manager licensed in the State. D. The appointed non-licensed individual may begin acting as the interim assisted living manager upon appointment. E. No later than 24 hours after the appointment of the non-licensed individual as interim assisted living manager, under §A of this regulation, the assisted living program shall: (1) File an application with the Board requesting a provisional license for the non-licensed individual; (2) Notify the Board of the circumstances involved in the departure of the licensed assisted living manager; (3) Notify the Board of the credentials of the non-licensed individual; and (4) If requested, provide the Board with the actions the assisted living program took, or is taking, to hire an assisted living manager licensed in the State. F. State and National Criminal History Records Check. The appointed non-licensed individual shall immediately submit to a criminal history records check, in accordance with Health Occupations Article, §9-302.1, Annotated Code of Maryland. (1) A criminal history records check is not required if the appointed non-licensed individual is actively licensed by a health occupations board in the State who previously has completed a criminal history records check required for licensure, certification, or registration. (2) The Board may deny approval of an appointment based on the results of a criminal history records check after consideration of the factors listed in Health Occupations Article, §9–3A–05(b)(1), Annotated Code of Maryland. G. Provisional License. The Board may issue a provisional license to the applicant if the Board determines that: (1) The applicant is of good moral character; (2) The departure of the licensed assisted living manager was by unexpected cause; and (3) The applicant is capable of adequately administering the assisted living program for the provisional period. H. If the Board grants the application for the provisional assisted living manager license, the provisional license is in effect for 90 days from the date of the departure of the licensed assisted living manager. For good cause shown, the Board may extend the provisional license period by 30 days. I. Denial of Provisional License. (1) If the application for a provisional license is denied by the Board, the assisted living program may request a meeting with the Board to contest the denial. (2) The assisted living program shall provide the request for a meeting to the Board within 5 business days of the denial. (3) If the assisted living program requests a meeting, the appointed non-licensed individual may remain acting as the interim assisted living manager until the Board issues a decision. (4) If the assisted living program does not file a timely request for a meeting with the Board, the non-licensed individual shall cease acting as the interim assisted living manager after 5 days from the denial. (5) If the Board denies the application for a provisional license after a meeting contesting the initial denial, the non-licensed individual shall cease acting as the interim assisted living manager upon receipt of the decision. J. If the non-licensed individual is required to cease acting as the interim assisted living manager under §I(4) and (5) of this regulation, and an assisted living manager licensed in the State remains unavailable to fill the assisted living manager position, the assisted living program may appoint another non-licensed individual set forth in this regulation. K. As a result of §J of this regulation, if the assisted living program appoints another non-licensed individual, and a provisional license is granted, the provisional license is in effect for 90 days from the date of the departure of the assisted living manager licensed in the State, unless the Board extends the provisional license, for good cause, for an additional 30 days. L. Upon request by the assisted living program, for reasonable cause, the Board may extend the 24-hour time period for meeting the requirements of §E of this regulation. #### Regulation .05 Renewals. *COMAR 10.33.03.05* A. A license expires on the second anniversary of its effective date, unless the license is renewed for a 2–year term as provided in this regulation. B. The Board shall send each licensee a renewal notice that states the: (1) Date on which the current license expires; (2) Latest date by which the renewal application and documentation can be received by the Board in order for the renewal license to be issued before the current license expires; and (3) Amount of the renewal fee as specified in COMAR 10.33.05.02D. C. At least 30 days before the current license expires, the Board shall send the renewal notice by: (1) Electronic means to the last known electronic mail address; or (2) First-class mail to the physical address of the licensee. D. Licensees shall satisfactorily complete the minimum continuing education requirements set forth under COMAR 10.07.14.16C. E. A licensee shall complete an implicit bias and structural racism training program approved by the Cultural and Linguistic Health Care Professional Competency Program in accordance with Health-General Article, §20-1306, Annotated Code of Maryland, for an applicant’s first renewal after April 1, 2026. #### Regulation .06 Reinstatement After License Expiration. *COMAR 10.33.03.06* A. The Board shall reinstate an individual whose license has expired if the individual: (1) Meets the renewal requirements of this chapter and Health Occupations Article, §9-3A-09, Annotated Code of Maryland; (2) Pays the reinstatement fee as specified under COMAR 10.33.05.02D; and (3) Satisfactorily completes the minimum continuing education requirements set forth under COMAR 10.07.14.16C. B. An assisted living manager who fails to apply for licensure reinstatement within 5 years after the expiration date of the license shall meet the requirements for a new license in effect at the time of the request in order to be licensed to practice as an assisted living manager in the State. #### Regulation .07 Inactive Status and Reactivation. *COMAR 10.33.03.07* A. In accordance with Health Occupations Article, §9-3A-10, Annotated Code of Maryland, a request by an active licensee to transfer a license to inactive status shall be granted upon receipt of the: (1) Completed Board-approved inactive status application; and (2) Payment of the required, non-refundable, biennial inactive status fee set forth in COMAR 10.33.05.02D. B. An individual: (1) May apply for inactive status only if the individual’s license is still active at the time the inactive status application request is made; (2) Shall renew and pay the biennial inactive status fee during each renewal period; and (3) Is not authorized to and may not practice as an assisted living manager in the State while on inactive status. C. Reactivation. (1) The Board shall reactivate the license of a licensee who is on inactive status for less than 5 years if the licensee: (a) Completes an application form for reactivation of the license before expiration of the 2–year term of inactive status on the form required by the Board; (b) Complies with the renewal requirements in effect at the time the licensee seeks to reactivate the license; (c) Meets the continuing education requirements set by the Board under COMAR 10.33.04.02; (d) Has not practiced as an assisted living manager in the State while on inactive status; (e) Pays all appropriate fees set by the Board under COMAR 10.33.05.02D; and (f) Is otherwise entitled to be licensed. (2) Before the Board may reactivate the license of an individual who has been on inactive status for 5 years or more, the individual shall: (a) Submit a new online application; (b) Pay all appropriate fees set by the Board; (c) Complete a Department-approved assisted living manager training course; and (d) Submit to a State and national criminal history records check in accordance with Health Occupations Article, §9–3A-05, Annotated Code of Maryland. (3) An assisted living manager whose inactive status expires before the license is reactivated shall meet the reinstatement requirements of Health Occupations Article, §9–3A–09, Annotated Code of Maryland. #### Regulation .08 Incomplete Applications. *COMAR 10.33.03.08* A. The Board is not required to consider an application that is incomplete. B. The applicant shall submit to the Board any additional relevant documentation requested by the Board if the Board determines the application documentation received is incomplete or insufficient. C. The Board may hold an incomplete application for a license for up to 1 year from the date of receipt. D. After 1 year from the date of receipt, the Board shall close a pending application that is incomplete. E. If an application has been closed under §D of this regulation, to obtain a license the applicant shall submit a new application fee and otherwise comply with all applicable license requirements. #### Regulation .09 Display of License. *COMAR 10.33.03.09* Each individual licensed as an assisted living manager in the State shall display printed verification of licensure in a conspicuous place in the office or place of business or employment of the licensee. #### Regulation .10 Change of Mailing Address, Legal Name, or Email Address. *COMAR 10.33.03.10* A. A licensed assisted living manager shall give the Board written or electronic notice within 30 days of a change of: (1) Mailing address; (2) Legal name; or (3) Email address. B. Failure to notify the Board of any change of mailing address, legal name, or email address within 30 days of the change may result in a fine as set forth under COMAR 10.33.05.02D. ### Chapter 04 — Continuing Education Requirements **Authority:** Health-General Article, §19-1807; Health Occupations Article, §§9-205 and 9-311; Annotated Code of Maryland **Administrative History:** Effective date: January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Continuing Education Requirements for Nursing Home Administrators. *COMAR 10.33.04.01* A. The approval of continuing education hours shall be at the discretion of the Board. B. Before renewal, a nursing home administrator shall submit satisfactory evidence of having completed a minimum of 40 hours of Board approved continuing education, unless otherwise specified by State or federal law, within the 2-year period before the renewal date. C. The Board shall audit a percentage of nursing home administrators, to be determined by the Board, for each reporting period. D. On request by the Board, a nursing home administrator shall provide full documentation of the credit hours completed in accordance with the requirements of this regulation. E. All continuing education shall be completed in courses approved by NAB, except as provided in §§F and G of this regulation. F. The Board shall award 10 hours of continuing education for each completed college credit from an accredited institution that falls within the subjects outlined in COMAR 10.33.02.03A. G. The Board shall award 1 hour of continuing education for each month a preceptor serves as an instructor in an AIT program, up to a maximum of 12 credit hours per renewal cycle. H. A licensee suspended for disciplinary reasons is not exempt from the continuing education requirement in this regulation. #### Regulation .02 Continuing Education Requirements for Assisted Living Managers. *COMAR 10.33.04.02* A. The approval of continuing education hours shall be at the discretion of the Board. B. Before renewal, an assisted living manager shall submit satisfactory evidence of having completed a minimum of 20 hours of Department approved continuing education, unless otherwise specified by State or federal law, within the 2-year period before the renewal date. C. The Board shall audit a percentage of assisted living managers, to be determined by the Board, for each reporting period. D. On request by the Board, an assisted living manager shall provide full documentation of the credit hours completed in accordance with the requirements of this regulation. E. A licensee suspended for disciplinary reasons is not exempt from the continuing education requirement in this regulation. ### Chapter 05 — Fees **Authority:** Health Occupations Article, §§9-205, 9-206, 9-311—9-312.1, 9-3A-03, and 9-3A-08—9-3A-10, Annotated Code of Maryland **Administrative History:** Effective date: January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Scope. *COMAR 10.33.05.01* This chapter governs all individuals licensed or applying for licensure by the Board under this subtitle. #### Regulation .02 Fees. *COMAR 10.33.05.02* A. The fee for a license shall be established by the Board under this subtitle. B. The fee shall be payable on notification by the Board that the applicant has successfully completed the requirements for licensure or renewal. C. The license fee or license renewal fee does not include costs for participating in educational courses or for the examination. D. Fee Schedule. (1) Initial application — $100. (2) License fee — $200. (3) Biennial license renewal — $200. (4) Reinstatement fee — $300. (5) Inactive status fee — $100. (6) Biennial inactive renewal — $100. (7) Reactivation fee — $200. (8) Fine for failure to notify Board of change in either name, home address of the licensee, or email address, or change in name or address of the employer or business connection of the licensee within 30 days of the change — $100. (9) NAB Examinations. The National Association of Long-Term Care Administrators Boards, Inc. determines the fees for the National Licensure Examination for nursing home administrators. A fee is charged each time an applicant takes an exam. (10) State Standards Examination. The examination service determines the fee for the State standards exam. A fee is charged each time an applicant takes the exam. E. All fees are non-refundable. ### Chapter 06 — Code of Ethics **Authority:** Health Occupations Article, §§9-205, 9-314, and 9-3A-12, Annotated Code of Maryland **Administrative History:** Effective date: January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Scope. *COMAR 10.33.06.01* This chapter applies to all licensees of the Board. #### Regulation .02 Ethical Principles. *COMAR 10.33.06.02* A. A licensee shall: (1) In all professional relationships, be honest and practice with compassion and respect for the dignity and rights of the individual, with commitment to the care, safety, and well-being of the residents being paramount; (2) Practice in a manner consistent with the laws and standards of practice pertaining to the nursing home or assisted living program the licensee administers or manages; (3) Provide a safe and healthy environment which shall protect the rights of the residents; (4) Promote and enhance their profession and its standards by increasing awareness and understanding of healthcare and their profession; (5) Be responsible for maintaining their professional competence and to continue professional development and growth through continuing education; and (6) Safeguard the confidentiality and privacy of information regarding residents consistent with existing law and professional standards. B. A licensee may not discriminate on the basis of race, color, sex, religion, age, national origin, disability, or other basis prohibited by State or federal law or regulation. ### Chapter 07 — Sanctions and Disciplinary Proceedings **Authority:** Health-General Article, §§2-104 and 19-1809; Health Occupations Article, §§1-212, 1-602—1-609, 9-205, 9-313—9-316.1, 9-3A-11—9-3A-17, and 9-401—9-407; State Government Article, §§10-201—10-226; Annotated Code of Maryland **Administrative History:** Effective date: January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Scope. *COMAR 10.33.07.01* These regulations govern procedures for disciplinary and licensing proceedings before the Board. #### Regulation .02 Definitions. *COMAR 10.33.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative prosecutor” means the attorney assigned from the Office of the Attorney General to prosecute the Board’s administrative charges on behalf of the State. (2) “Charges” means the accusations or grounds for action that the Board alleges a respondent committed which concerns: (a) A disciplinary action against a licensee that may result in sanctions against a licensee; (b) Intent to deny an initial application for licensure; (c) An action against an individual practicing nursing home administration or assisted living management without a license; or (d) Other action authorized by law or regulation against an individual, licensee, or applicant that entitles the respondent to a contested case hearing. (3) “Charging document” means the document that includes the charges that initiates a Board action against a respondent and gives formal notice to the respondent of an action by the Board. (4) Complaint. (a) “Complaint” means an allegation or report received by the Board that indicates: (i) A Board licensee may have committed an act or omission for which the licensee may be disciplined or sanctioned; (ii) An applicant may have committed an act or omission that could result in the denial of the applicant’s application for a license; or (iii) An individual may be practicing either nursing home administration or assisted living management without a license. (b) “Complaint” may include, but is not limited to, the following: (i) Consumer complaints and complaints from the public; (ii) Reports or allegations from a government entity concerning a nursing home or assisted living program at which the licensee, applicant, or individual is or was employed; (iii) Media reports; (iv) Statements on Board applications for licensure; (v) Reports from anonymous sources; or (vi) Information from any source that warrants an investigation. (5) “Preliminary investigation” means a review of the allegations in a complaint by the Board and the response from a respondent, if sought and provided, that determines whether there is a sufficient basis for a formal Board investigation. (6) “Respondent” means a licensee, applicant, or individual who: (a) Is under investigation by the Board; or (b) Has been charged by the Board. #### Regulation .03 Complaints, Investigations, and Disposition of Complaint. *COMAR 10.33.07.03* A. Complaint. (1) Any person, government entity, public officer, association, or the Board may submit to the Board a complaint against any licensee, applicant, or individual for due cause. (2) The Board shall investigate and take appropriate action as to any complaint filed with the Board that alleges or indicates that: (a) A licensee has failed to meet any standard governing the practice of the licensee’s profession; (b) A licensee or an applicant has violated disciplinary grounds of the Board; or (c) An unlicensed individual: (i) Is practicing nursing home administration or assisted living management in this State without a license or proper authorization; or (ii) Has represented to the public that the individual is authorized to practice nursing home administration or assisted living management in this State without a license or proper authorization from the Board. (3) The Board may investigate responses in a Board licensure application that may warrant denial of the application. B. Representation by Counsel. (1) A respondent may be represented by counsel in any matter before the Board and at any stage of the proceedings. (2) If the matter goes to a hearing, a respondent may be represented by: (a) The respondent; or (b) An attorney who is: (i) Admitted to the Maryland Bar; or (ii) Specially admitted to practice law pursuant to Maryland Rule 19-217. (3) An administrative prosecutor assigned to the Board by the Office of the Attorney General shall prosecute disciplinary matters in Board proceedings. (4) The Board may be represented by and obtain the advice of counsel assigned to it by the Office of the Attorney General in all proceedings. C. Confidentiality of Proceedings. (1) Except as otherwise provided by law, the proceedings of the Board are confidential. The parties may not waive the confidentiality provided by this regulation. (2) The Office of Administrative Hearings’ proceedings involving the adjudication of a Board-contested case and the administrative law judge's proposed decision are confidential. The parties may not waive the confidentiality of the proceedings or of the residents whose medical records or care are reflected in the record of the proceedings. (3) Except as otherwise provided by law, even after a final decision is issued by the Board, the parties may not reveal the identity of any residents or patients referenced in the Board proceeding. D. Investigation of Complaint. (1) After receipt of a complaint, the Board staff: (a) Shall send an acknowledgement to the complainant; (b) Shall present the complaint to the disciplinary committee of the Board; and (c) May forward the complaint to another regulatory agency that has jurisdiction over the matter. (2) The Board's disciplinary committee shall: (a) Review a complaint over which the Board has jurisdiction; and (b) Make a recommendation to the Board on whether to open a formal investigation of a complaint. The disciplinary committee may recommend to the Board closure of the case based on a preliminary investigation of the complaint. (3) Prior to or after a decision on whether to open a formal investigation of a complaint, the Board may send a summary or a copy of the complaint, either in its entirety or redacted, to the licensee, applicant, or individual who is the subject of the complaint to obtain a response to the allegations made in the complaint. (4) Participation in review of complaints made to the Board is not a basis for recusal of a Board member, Board counsel, or the administrative prosecutor from further proceedings in the case. (5) If the Board votes for a formal investigation, an investigator shall be assigned to the investigation. (6) As part of its investigation, the Board may issue investigative subpoenas requiring attendance and testimony or the production of records or tangible objects. The subpoena shall be: (a) Signed by: (i) The Board’s Executive Director; or (ii) A Board officer; (b) Served by: (i) U.S. first-class mail; (ii) Certified mail to the address the respondent is required to maintain with the Board; (iii) Hand delivery in-person or by courier; (iv) Delivery service for which a signature is required; (v) Electronic means; or (vi) A method otherwise agreed to by the person or government entity to whom the subpoena is directed or the person’s counsel. E. Subpoenas. If service of the subpoena is provided by electronic means, under §D(6)(b)(v) of this regulation, and no response or delivery receipt is obtained from the e-mail address to which service of the subpoena was provided, the Board shall serve the subpoena through other means under §D(6)(b) of this regulation. F. Except as otherwise provided by law, Board investigations are confidential. G. For each complaint, after a review of the complaint, pertinent investigative material, and the disciplinary committee’s recommendation, the Board shall: (1) Close the case; (2) Close the case with a nonpublic informal advisory letter to the licensee; or (3) Vote to take any of the following actions: (a) Charge the licensee with a violation or violations of Health Occupations Article, §§9-314 or 9-3A-12, Annotated Code of Maryland, or a violation or violations of Regulation .06 of this chapter; (b) Summarily suspend a license or issue a Notice of Intent to Summarily Suspend; (c) Issue an intent to deny an application for licensure; (d) Issue a cease and desist order; or (e) Take any action against a respondent authorized by the subtitle or law that entitles the respondent to a contested case hearing. H. Referral to Prosecutor. (1) After a vote for disciplinary action or actions, the matter shall be referred to an administrative prosecutor for prosecutorial action. (2) After the administrative prosecutor has drafted the charging document, notice, or order of the disciplinary action or actions, if acceptable, a Board officer or the Board Executive Director shall sign the charging document, notice, or order of the disciplinary action or actions and the licensee, applicant, or individual shall be served. #### Regulation .04 Pre-Hearing Procedures. *COMAR 10.33.07.04* A. The charging document shall: (1) Give reasonable notice of the Board’s action; (2) Comply with State Government Article, §10-207, Annotated Code of Maryland; (3) Notify the respondent of, if applicable: (a) Any proceedings scheduled before the Board and the consequences of failing to appear for those proceedings; and (b) An opportunity to request a hearing within a certain period of time and the consequences of failing to request a hearing; and (4) Be accompanied by a letter of procedure notifying the respondent of the applicability of the Administrative Procedure Act to the Board's proceedings. B. If the respondent does not participate in the Board proceeding without a valid reason, the Board may nevertheless proceed in adjudicating the case or issue a default order. C. If the Board initiates an investigation or if the Board issues a notice of initial denial to an applicant for a license, the applicant may not withdraw the application without approval of the Board. D. A notice of denial of a provisional license does not entitle the applicant, nursing home, or assisted living program to a hearing under this chapter. E. After the administrative prosecutor has drafted the charging document, if acceptable, a Board officer or the Board Executive Director shall sign the charging document. F. An investigation and prosecution of charges may proceed if a respondent's license expires after a Board investigation has been initiated or charges have been issued. G. Service of the Charging Document. If the Board issues a charging document, the charging document shall be served upon the respondent at the address the respondent maintains for purposes of licensure or the respondent’s last known address by: (1) U.S. first-class mail; (2) Certified mail; (3) Hand delivery in person or by courier; (4) Delivery service for which a signature is required; (5) Electronic means; or (6) A method otherwise agreed to by the respondent or respondent’s counsel. H. If service of the charging document is provided by electronic means, under §G(5) of this regulation, and no response or delivery receipt is obtained from the e-mail address to which service of the charging document was provided, the Board shall serve the charging document through other means under §G of this regulation. I. Case Resolution Conference. (1) After service of the charging document or notice of initial denial, the Board shall offer a respondent the opportunity for a case resolution conference. (2) Matters admitted, revealed, negotiated, or otherwise discussed at a case resolution conference are confidential and without prejudice and may not be used by the respondent, administrative prosecutor, or Board in any subsequent proceedings, unless the information is otherwise discovered or available by other appropriate means. (3) Recommendations of the case resolution conference committee are not binding on the Board, which may: (a) Accept the proposed resolution; or (b) Modify a proposed settlement. (4) If the respondent and the administrative prosecutor are unable to reach an agreement for settlement that is proposed by the case resolution conference committee, or the Board, the matter shall proceed to a hearing on the charges. (5) Participation in a case resolution conference is not a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings in a case. J. Discovery. (1) Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce copies of documents that the opposing party intends to be produced at the hearing within 30 days of service of the request. (2) Mandatory Discovery. (a) At least 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier, each party shall provide to the other party: (i) The name and curriculum vitae of any expert witness who will testify at the hearing; and (ii) A detailed written report summarizing the expert testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion. (b) Upon motion, if the Board Chair or the Board Chair’s designee, who shall be a Board member, or the Office of Administrative Hearings, as appropriate, finds that the expert report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, or the proposed expert is unqualified, the testimony of the expert and any report of the expert shall be excluded from the hearing. (c) If an expert adopts a sufficiently specific charging document as the expert report, that adoption shall satisfy the requirements set forth in this section. K. Motions and Orders for a Hearing Before the Board. (1) Motions shall: (a) Be in writing and filed with the Board and shall include the pertinent facts and legal authorities relied upon; (b) Be decided by the Chair of the Board or the Chair’s designee, who shall be a Board member; (c) Be served upon the opposing party’s legal counsel, if the opposing party is represented, and upon the opposing party, if not represented by legal counsel; and (d) Contain a certificate of service. (2) Unless shortened or extended by the presiding officer, the opposing party has 15 days from service of the motion to respond to the motion. (3) Except as otherwise provided by this regulation, the Chair of the Board or the Chair’s designee, who shall be a Board member, may decide any issues needed to facilitate Board proceedings after the charging document is issued. (4) Parties may be notified of decisions and orders from this chapter by the Board’s Executive Director, who may also sign decisions and orders on behalf of the Board or the Board decision maker. L. Pre-Hearing Conference for Hearings Before the Board. (1) The Board may hold a pre-hearing conference. (2) If the Board holds a pre-hearing conference, at minimum: (a) A Board member shall attend; and (b) Both parties shall disclose any: (i) Anticipated witnesses; and (ii) Documents anticipated to be offered into evidence. (3) Both parties have a continuing duty to supplement their disclosures of witnesses and documents. (4) The parties shall comply with the pre-hearing conference instructions and orders. (5) In the case of unforeseen circumstances which would otherwise impose an extraordinary hardship on a party: (a) If a prehearing conference is scheduled, witnesses or documents may not be added to the list after the prehearing conference; or (b) If no prehearing conference is scheduled, witnesses or documents may not be added to the list later than 15 days before the hearing. (6) The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes. (7) Failure to comply with discovery, pre-hearing conference instructions, or orders may result in the exclusion of witnesses from testifying or documents from being admitted or default. #### Regulation .05 Hearings and Final Decisions. *COMAR 10.33.07.05* A. Hearings shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (1) The Board may delegate the Board’s authority to hear contested cases to the Office of Administrative Hearings on a case-by-case basis. (2) Proceedings are not open to the public. (3) Hearings may be held by electronic means. B. Burden of Proof. A party asserting the affirmative of an issue bears the burden of proof regarding the issue. C. Order of Procedure. The party with the burden of proof shall present their case first. D. Hearings Conducted Before the Board. (1) The Board shall notify the parties of the date, time, and place of the hearing. (2) Each hearing shall be held before a majority of the Board. (3) The delegation for an evidentiary hearing to an administrative law judge shall be by the Board at its discretion. (4) Presiding Officer. For hearings before the Board, the Board Chair, or, in the Chair's absence, a member designated by the Chair shall be the presiding officer of the hearing. The presiding officer shall: (a) Have complete charge of the hearing proceedings; (b) Rule on any matter to facilitate the hearing; (c) Permit the examination of witnesses; (d) Rule on the admissibility of evidence; (e) Admit evidence; and (f) Adjourn or recess the hearing from time to time. (5) The presiding officer, at the presiding officer's discretion, may set reasonable time limits on arguments and presentation of evidence. (6) The presiding officer shall be responsible for decorum in a hearing and can suspend the proceedings as necessary to maintain decorum. (7) Legal Advisor and Counsel for the Board. A representative of the Office of the Attorney General shall act as legal advisor and counsel to the Board. (8) Administrative Prosecutor. (a) The Board may request the Office of the Attorney General, Health Occupations and Prosecution Unit to participate as the administrative prosecutor in any hearing to present the case on behalf of the State. (b) The administrative prosecutor that presents the case on behalf of the State shall have the same rights with regard to the submission of evidence, examination, cross-examination of witnesses, presentation of summation and argument, and filing of objections, exceptions, and motions as does the respondent and respondent’s counsel for any party. (9) Examination of Witnesses and Introduction of Evidence. (a) The rules of evidence in all hearings under these regulations shall be as set forth in State Government Article, §10-213, Annotated Code of Maryland. (b) Every party has the right to call witnesses and present evidence, cross-examine every witness called on behalf of the Board or other party, and present summation and argument and file objections, exceptions, and motions. (c) When a party is represented by counsel, all submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by counsel. (d) The presiding officer, or any person designated by the presiding officer for that purpose, may examine any witness called to testify. Any member of the Board may examine any witness called to testify. E. Evidentiary Hearings Conducted at the Office of Administrative Hearings. (1) Unless specified otherwise in this chapter, hearings delegated to the Office of Administrative Hearings are governed by the Office of Administrative Hearings Rules of Procedure, pursuant to COMAR 28.02.01. (2) Proceedings are not open to the public. (3) The Board action concerning charges against a nursing home administrator or an assisted living manager may be consolidated for the evidentiary hearing at the Office of Administrative Hearings, with a disciplinary action against a nursing home or assisted living program, brought by the Department if: (a) The licensed nursing home administrator or licensed assisted living manager of the Board action administered or managed the facility that is the subject of the Department’s action; and (b) The issues and facts in the cases are sufficiently similar. (4) If a matter has been delegated to the Office of Administrative Hearings, unless otherwise specified by the Board, the administrative law judge presiding over the proceedings shall issue to the Board a proposed decision which shall include: (a) Proposed findings of fact; (b) Proposed conclusions of law; and (c) A proposed sanction. F. Exceptions and Exceptions Hearing. (1) If a matter has been delegated by the Board to the Office of Administrative Hearings or to an individual member of the Board, a party may file exceptions to the proposed decision before the Board makes a final decision. (2) Unless otherwise permitted by the Board, within 21 days after the issuance of the proposed decision, either party may file written exceptions with the Board. (3) Unless otherwise permitted by the Board, a party’s written exceptions may not be longer than 25 double-spaced pages and shall state with particularity the: (a) Finding of fact; (b) Conclusion of law or other matter excepted to; and (c) Relevant portions of the record supporting the party’s exception. (4) Unless otherwise permitted by the Board, within 15 business days after a party’s exceptions are filed with the Board, the opposing party may file an answer to exceptions. (5) Unless otherwise permitted by the Board, a party’s answer to exceptions may not be longer than 25 double-spaced pages and shall state with particularity: (a) A response to an exception; and (b) The relevant portions of the record supporting that response. (6) Unless otherwise agreed to by the parties and permitted by the Board, an exceptions hearing shall be scheduled for the next meeting of the Board after receipt of the parties’ exceptions and any answer to exceptions. (7) Exceptions Hearing. (a) An exceptions hearing shall be held before the Board. (b) The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions and answers to exceptions. (c) The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party’s oral argument. (d) The presiding Board member shall make rulings reasonably necessary to facilitate the exceptions hearing. (e) The respondent and the administrative prosecutor may not exceed 30 minutes to present oral argument per side, unless approved by the presiding officer. (f) The party who filed the exceptions shall proceed first and may reserve part of the allotted time for rebuttal. (8) Unless otherwise agreed to by the parties and permitted by the Board, in an answer to exceptions or in the hearing on exceptions, the parties may not reference any document or other evidence or offer an exhibit that is outside the record of the evidentiary hearing before the administrative law judge. (9) If neither party files exceptions within the time specified in §C(2) of this regulation, in making the Board's final decision, the Board shall consider only the: (a) Proposed decision of the administrative law judge; and (b) Record of the evidentiary hearing. G. Final Decision. After a formal hearing is conducted, the Board shall issue a written final decision to be sent to the parties upon issuance which shall include: (1) Findings of fact; (2) Conclusions of law; (3) An order; and (4) Appeal rights, if applicable. #### Regulation .06 Grounds for Sanctioning and Sanctions. *COMAR 10.33.07.06* A. The Board may deny a license to any applicant, suspend or revoke the license of a licensee, place on probation, reprimand, or fine a licensee after proper notice and a hearing, if the applicant or licensee: (1) Violated any of the provisions of law or regulations pertaining to the licensing or practice of nursing home administration or assisted living management; (2) Violated any of the provisions of the law or regulations of the: (a) Licensing or oversight authority or agency of the State for nursing homes or assisted living programs; or (b) Federal entity having jurisdiction over the operation of nursing homes; (3) Is incompetent to engage in the practice of nursing home administration or assisted living management or to act as a nursing home administrator or assisted living manager; (4) Engaged in fraud, deceit, or misrepresentation in the licensee’s or applicant’s capacity as a nursing home administrator or assisted living manager; (5) Wrongfully transferred or surrendered possession of, either temporarily or permanently, an individual’s license; (6) Paid, gave, caused to be paid or given, or offered to pay or be given to any person a commission or other valuable consideration for the solicitation or procurement, either directly or indirectly, of nursing home or assisted living program patronage; (7) Used fraudulent, misleading, or deceptive advertising; (8) Falsely impersonated another licensee; (9) Endangered or sanctioned the endangerment of the safety, health, or life of any resident of a nursing home or assisted living program; (10) Violated a resident’s rights or allowed a resident’s rights to be violated; (11) Failed to oversee and facilitate the nursing home’s or assisted living program’s quality improvement processes to the extent that the safety, health, or life of any resident has been endangered; (12) Willfully permitted the unauthorized disclosure of information relating to a resident or the resident’s records; (13) Discriminated against residents, employees, or staff on account of race, religion, national origin, sexual orientation, or disability; (14) Violated the Code of Ethics set forth under COMAR 10.33.06; (15) Engaged in sexual behavior that would be considered unethical or unprofessional according to professional standards of conduct, including, but not limited to: (a) Sexual behavior with a resident or patient in the context of a professional evaluation, treatment, procedure, or service to the resident or patient, regardless of the setting in which the professional service is rendered; (b) Sexual behavior with a resident or patient under the pretext of diagnostic or therapeutic intent or benefit; (c) Solicitation of a sexual relationship, whether consensual or nonconsensual, with a resident or patient; (d) Sexual advances requesting sexual favors; (e) Therapeutically inappropriate or intentional touching of a sexual nature; (f) A verbal comment of a sexual nature; (g) Physical contact of a sexual nature with a resident or patient; (h) Discussion of unnecessary sexual matters with a resident or patient; (i) Direct or indirect observation of a resident or patient while the resident or patient is undressing or dressing; (j) Taking photographs or video of a resident or patient for a sexual purpose; (k) Sexual harassment of staff, students, or volunteers; (l) An unnecessary sensual act or comment; (m) Sexual contact with an incompetent or unconscious client, patient, or resident; or (n) Offering to provide services or material in exchange for sexual favors; (16) Practiced as a nursing home administrator or assistant living manager in the State without a license from the Board or without proper authorization to practice as a nursing home administrator or assistant living manager; (17) Falsified continuing education records; or (18) Failed to cooperate with an investigation, proceedings, or other requirements of the Board. B. The Board may, after due notice and an opportunity to be heard, suspend or revoke an AIT’s participation in a Board-approved AIT program, upon substantial evidence that the AIT has committed any of the actions listed in §A of this regulation. C. A licensee shall notify the Board in writing within 30 days if the licensee has been sanctioned by a licensing authority of another state for the practice as a nursing home administrator or assistant living manager. D. On finding that there has been a violation of Health Occupations Article, Title 9, Annotated Code of Maryland, or this subtitle, and in accordance with the applicable notice and due process procedures, the Board may order that the: (1) Licensee be fined; (2) Licensee be reprimanded; (3) Licensee be placed on probation with appropriate terms and conditions; (4) Licensee’s license be suspended, with or without terms and conditions; or (5) Licensee’s license be revoked. E. The Board may order any of the sanctions listed in §A of this regulation in combination or individually as appropriate for the violations committed by the licensee. #### Regulation .07 Sanctioning Guidelines. *COMAR 10.33.07.07* A. If the Board concludes that a licensee has violated a ground for discipline under Health Occupations Article, §§9-314(b) or 9-3A-12(b), Annotated Code of Maryland, or under this chapter, the Board shall: (1) Determine the applicable sanction range according to the guidelines set forth in Regulation .08 of this chapter; (2) Consider the applicable aggravating and mitigating factors set forth in §J of this regulation to determine whether the sanction should fall outside the indicated range of sanctions; and (3) After considering any applicable aggravating and mitigating factors, impose the appropriate sanction. B. The Board is not required to make findings of fact with respect to any of the factors for determining the sanction indicated by the sanctioning guidelines. C. In the event that a licensee’s violation of the Board’s statutes or regulation does not fall within a sanction range, the Board shall so indicate and use its best judgment to determine the appropriate sanction and consider, to the extent possible, the factors in the sanctioning guidelines. D. If the Board deviates from the sanctioning guidelines, the Board shall state its reasons for the deviation. E. A departure from the sanctioning guidelines is not an independent ground for an appeal or challenge of a Board action. F. Notwithstanding this regulation, in order to resolve a disciplinary proceeding, the Board and the licensee may agree to a surrender of license or a Consent Order with terms and sanction agreed to by the Board and the licensee. G. In a case where there are multiple and distinct violations, the Board may impose a sanction greater than the maximum indicated by the sanctioning guidelines for each individual violation. H. If probation or suspension is imposed, the Board may impose appropriate terms and conditions for the probation or suspension. If a licensee violates the terms or conditions of the probation or suspension, the Board may take further disciplinary action against the licensee, as provided in the Board order. I. Pursuant to Health Occupations Article, §§9-314.1 and 9-3A-13, Annotated Code of Maryland, if a civil fine is imposed, the fine may not exceed $1,000 for a first violation or $5,000 for any subsequent violation of the same provision. J. Aggravating and Mitigating Factors. (1) Mitigating Factors. In determining whether the sanction falls outside the indicated range of sanctions guidelines listed in Regulation .08 of this chapter, the Board may consider the following mitigating factors: (a) Absence of a prior disciplinary record; (b) That the licensee reported the violation to the Board; (c) That the licensee: (i) Voluntarily admitted violation; (ii) Provided full disclosure to the Board; and (iii) Cooperated during Board proceedings; (d) That the licensee implemented remedial measures to correct or mitigate harm arising from the violation; (e) That the licensee made a timely good-faith effort to make restitution or otherwise rectify the consequences of the violation; (f) Evidence of the licensee’s rehabilitation or potential for rehabilitation; (g) Absence of premeditation to commit the violation; (h) Absence of potential harm to or adverse impact on the public; (i) That the incident was isolated and is not likely to recur; or (j) If the licensee has worked at the nursing home or assisted living program for a limited period, and the violation was present before beginning work at the facility or program. (2) Aggravating Factors. In determining whether the sanction of the licensee falls outside the indicated range of sanctions guidelines listed in Regulation .08 of this chapter, the Board may consider the following aggravating factors: (a) The licensee’s previous criminal or administrative disciplinary history; (b) If the violation was committed deliberately or with gross negligence or recklessness; (c) If the violation had the potential for, or caused, serious resident harm; (d) If the violation was part of a pattern of detrimental conduct; (e) If the licensee pursued the licensee’s financial gain over a resident’s welfare; (f) That the resident was especially vulnerable; (g) That the licensee attempted to: (i) Conceal the violation; (ii) Falsify or destroy evidence; or (iii) Present false testimony or evidence; (h) That the licensee failed to cooperate with the Board’s investigation; or (i) That the licensee’s previous attempts at rehabilitation were unsuccessful. #### Regulation .08 Guidelines for Disciplinary Sanctions. *COMAR 10.33.07.08* A. Patient Safety. B. Fraud, Deceit, or Misrepresentation. C. General Misconduct. D. Records Violation Without Fraudulent or Deceitful Intent. E. Administrator-In-Training Violations by Nursing Home Administrator. #### Regulation .09 Surrender of License. *COMAR 10.33.07.09* A. This regulation pertains to the surrender of a license when: (1) A licensee is under investigation by the Board; or (2) Charges have been issued by the Board against a licensee. B. The surrender of a licensee’s license may be rejected by the Board. C. Letter of Surrender. (1) The language of the Letter of Surrender is subject to the approval of the Board. (2) If the Letter of Surrender is approved by the Board, it shall be signed by the respondent and the Board’s Executive Director. (3) The Letter of Surrender may include, but is not limited to: (a) The circumstances that resulted in the surrender; (b) The time period before the respondent may apply for reinstatement if the surrender is not permanent; and (c) Conditions before the respondent may apply for reinstatement. (4) The Letter of Surrender is a final order that is the result of formal discipline, and a public document, under: (a) General Provisions Article, §4-333, Annotated Code of Maryland; and (b) Health Occupations Article, §1-607, Annotated Code of Maryland. #### Regulation .10 Summary Suspensions. *COMAR 10.33.07.10* A. Pursuant to its authority under State Government Article, §10-226(c), Annotated Code of Maryland, the Board shall order the summary suspension of a license if the Board determines that the public health, safety, or welfare imperatively requires emergency action against the licensee. B. Notice of Intent to Summarily Suspend. (1) Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue a notice of intent to summarily suspend a license. (2) If the Board votes to issue a notice of intent to summarily suspend a license or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution. (3) A notice of intent to summarily suspend a license shall include: (a) A proposed order of summary suspension which is unexecuted by the Board and includes: (i) The statutory authority on which the action has been taken; (ii) Allegations of fact that the Board believes demonstrate that the public health, safety, or welfare imperatively requires emergency action against the licensee; and (iii) Notice to the respondent of the right to request a full hearing on the merits of the summary suspension if the Board executes the proposed order of summary suspension; and (b) An order or summons to appear before the Board to show cause as to why the Board should not execute the order of summary suspension, which notifies the respondent of the consequences of failing to appear. (4) Service. (a) The Board shall serve a respondent with a notice of intent to summarily suspend a license no later than 5 days before a pre-deprivation show cause hearing is scheduled before the Board. (b) Service of the notice of intent to summarily suspend shall be made as provided under COMAR 10.33.07.04G and H that includes proof of delivery. (c) If the Board is unable to serve the notice of intent to summarily suspend a license upon the respondent as described in §B(4)(a) and (b) of this regulation, the Board may nevertheless proceed to prosecute the case. C. Pre-Deprivation Opportunity to Be Heard. (1) If the Board issues a notice of intent to summarily suspend a license, the Board shall offer the respondent the opportunity to appear before the Board to show cause as to why the respondent’s license should not be suspended before the Board executes the order of summary suspension. (2) Pre-Deprivation Show Cause Hearing Before the Board. (a) The hearing shall be a non-evidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension. (b) The Board member presiding at the hearing shall determine all procedural issues and may impose reasonable time limits on each party’s oral argument. (c) The presiding Board member shall make rulings reasonably necessary to facilitate the effective and efficient operation of the hearing. (d) The respondent and the administrative prosecutor may not exceed 30 minutes each to present oral argument. (e) The respondent shall proceed first and may reserve part of the allotted time for rebuttal. (f) The presiding officer: (i) May allow either the respondent or the administrative prosecutor to present documents or exhibits which are relevant and material to the proceedings and which are not unduly repetitious, if the presiding Board member believes that the documents or exhibits are necessary for a fair hearing; and (ii) May not allow testimony by any witness unless agreed to by the parties and approved by the presiding Board member in advance of the hearing. (g) A Board member may be recognized by the presiding member to ask questions of either party appearing before the Board. D. Post-Deprivation Opportunity to be Heard. (1) Extraordinary Circumstances. The Board may, after consultation with Board counsel, order the summary suspension of a license without first issuing a notice of intent to summarily suspend a license or providing a respondent with an opportunity for a pre-deprivation hearing if the Board determines that: (a) The public health, safety, or welfare imperatively requires the immediate suspension of the license; and (b) Prior notice and an opportunity to be heard are not feasible. (2) Time — Service and Hearing. (a) An order of summary suspension under §D(1) of this regulation shall be served on the respondent promptly after its execution as provided by COMAR 10.33.07.04G and H that includes proof of delivery. (b) The respondent shall be provided an opportunity for a post-deprivation hearing before the Board within 15 days after the effective date of the summary suspension, which shall provide the respondent with an opportunity to show cause as to why the Board should lift the summary suspension and reinstate the license. (3) If the respondent requests a hearing under §B(3)(a)(iii) of this regulation, that hearing shall: (a) Be conducted before the Board; and (b) Provide the respondent with an opportunity to show cause as to why the Board should lift the summary suspension and reinstate the license. E. Burdens of Production and Persuasion. (1) In a show cause proceeding under §C of this regulation, the respondent may present argument in opposition to the allegations presented in the order for summary suspension or which otherwise demonstrate that the public health, safety, or welfare does not imperatively require the immediate suspension of a license. (2) The administrative prosecutor bears the burden of demonstrating by a preponderance of the evidence that the health, safety, or welfare of the public imperatively requires the Board to summarily suspend the respondent’s license. F. Disposition. (1) If the Board issues a notice of intent to summarily suspend a license before summarily suspending a license, the Board may, after the show cause hearing, vote to: (a) Order a summary suspension; (b) Deny the summary suspension; or (c) Issue an order agreed to by the parties. (2) If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the hearing, vote to: (a) Affirm its order of summary suspension; (b) Terminate or rescind the order for summary suspension; or (c) Issue an order agreed to by the parties. (3) An order for summary suspension or other order issued by the Board after the initiation of summary suspension proceedings are final orders of the Board and public records under General Provisions Article, §4-333, Annotated Code of Maryland. G. Post-Deprivation Opportunity for an Evidentiary Hearing. (1) If the Board orders the summary suspension of a license under §§C or D of this regulation, the respondent shall have an opportunity for an evidentiary hearing before the Board, or, if the Board delegates the matter to the Office of Administrative Hearings, before an administrative law judge. (2) The respondent may request an evidentiary hearing within 10 days after the Board issues the order of summary suspension. (3) An evidentiary hearing may be consolidated with a hearing on charges issued by the Board that include the facts which form the basis for the summary suspension. (4) An evidentiary hearing shall be conducted under the contested case provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. (5) If the Board delegates the matter to the Office of Administrative Hearings, unless otherwise specified by the Board, the administrative law judge shall issue a proposed decision to the Board with: (a) Proposed findings of fact; (b) Proposed conclusions of law; and (c) A proposed disposition. (6) If the hearing is one combined with charges, and the Board delegates the matter to the Office of Administrative Hearings, the administrative law judge’s determination of the merits of the summary suspension shall be based only on the parts of the record available to the Board when the Board voted for summary suspension. (7) The parties may file exceptions to the proposed decision, as provided in State Government Article, §10-216, Annotated Code of Maryland. (8) An order issued by the Board after a pre-deprivation or post-deprivation hearing is a public record under: (a) Health Occupations Article, §1-607, Annotated Code of Maryland; and (b) General Provisions Article, §4-333, Annotated Code of Maryland. #### Regulation .11 Cease and Desist Orders. *COMAR 10.33.07.11* A. The Board may issue a cease and desist order to an unlicensed individual practicing nursing home administration or assisted living management without a license or authorization from the Board. B. The cease and desist order shall be served upon the respondent as provided by COMAR 10.33.07.04G and H that includes proof of delivery. C. The respondent is entitled to a prompt opportunity to be heard by the Board to contest the cease and desist order. This opportunity to be heard shall be conducted by argument and record evidence, without witness testimony. D. If the Board upholds the cease and desist order under §C of this regulation, if requested, the respondent shall be entitled to an evidentiary hearing pursuant to the procedures under Regulation .05 of this chapter. #### Regulation .12 Show Cause Hearings. *COMAR 10.33.07.12* A. The Board may conduct a show cause hearing to determine whether a respondent violated an order of the Board. B. An order of the Board includes, but is not limited to: (1) Final decisions and orders; (2) Consent orders; or (3) Any order imposing probation, suspension, or another term or condition that the respondent is required to comply with. C. Failure to comply with any term or condition of an order of the Board is a violation of the order of the Board. D. Service of the show cause order shall be as provided by COMAR 10.33.07.04G and H. E. If the Board determines there is no genuine dispute of material facts that cannot be resolved at the show cause hearing, the show cause hearing may be conducted by argument by the parties and records offered for consideration by the Board. F. The Board, in its discretion, may allow for an evidentiary hearing if it determines there is a genuine dispute of material fact that cannot be resolved at the show cause hearing. #### Regulation .13 Petitions for Reinstatement Following License Revocation or Surrender. *COMAR 10.33.07.13* A. In order for a revoked or surrendered license to be reinstated, the individual whose license was revoked or surrendered shall petition the Board for reinstatement. B. A surrendered license in this regulation means a surrender, approved by the Board, while the individual was licensed and under investigation or charges had been issued by the Board. C. An individual who petitions the Board for reinstatement following the revocation or surrender of the individual’s license may petition for reinstatement only pursuant to the terms of the Board’s order revoking the license or the Letter of Surrender. The Board may set conditions precedent and a time period for petitioning for reinstatement or may permanently revoke or require permanent surrender. D. If the Board’s order revoking the license or the Letter of Surrender does not contain a time period for petitioning for reinstatement, the individual may petition for reinstatement after 3 years from revocation. E. A petitioner for reinstatement shall comply with all reasonable requests for information by the Board. F. The decision of the Board on whether to grant or deny the petition for reinstatement is a discretionary decision by the Board. G. If the Board denies a petition for reinstatement, the Board may set conditions precedent and a time period for further petitions for reinstatement. H. If the Board grants reinstatement, the Board may impose probationary conditions and restrictions along with the reinstatement. ### Chapter 08 — Compelling Purpose Disclosure **Authority:** General Provisions Article, §4-333; Health Occupations Article, §9-205; Annotated Code of Maryland **Administrative History:** Effective date: January 19, 2026 (53:1 Md. R 22) #### Regulation .01 Disclosure for Compelling Public Purpose. *COMAR 10.33.08.01* The Board’s Executive Director may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, whether or not there has been a request for the information and may disclose the information under the following circumstances: A. The information concerns possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority; B. The information concerns a possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the person or government entity whose conduct may be a violation, and the information disclosed is limited to information relevant to the possible violation by that individual; or C. The information concerns conduct by a person or government entity which the Board’s Executive Director reasonably believes may pose a risk to the public health, safety, or welfare and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other healthcare facility where the individual has privileges. #### Regulation .02 Other Disclosures. *COMAR 10.33.08.02* This chapter does not prevent or limit the ability of the Board to disclose general licensing information as provided in General Provisions Article, §4-333, Annotated Code of Maryland, or any information which the Board may otherwise disclose by law. ## Subtitle 34 — Board of Pharmacy ### Chapter 01 — Disciplinary Proceedings **Authority:** Health Occupations Article, §§12-313, 12-315, 12-6B-09 and 12-6D-11; State Government Article, §10-206; Annotated Code of Maryland **Administrative History:** Effective date: September 1, 1971 **Administrative History:** Regulation .03A, E, G amended effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulation .03D amended effective February 13, 1984 (11:3 Md. R. 202) **Administrative History:** Regulation .04A, G amended effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulation .04D, G amended effective October 3, 1980 (7:20 Md. R. 1879) **Administrative History:** Regulation .06 amended effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Chapter revised effective January 24, 2000 (27:1 Md. R. 77) **Administrative History:** Regulations .01 — .07 repealed and new Regulations .01 — .15 adopted effective September 1, 2003 (30:17 Md. R. 1203) **Administrative History:** Regulation .02B amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .06B, C amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .12 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .13A amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .14 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .15 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Annotation: COMAR 10.34.01.03G(1) cited in Eichberg v. Board of Pharmacy, 50 Md. App. 189 (1981) #### Regulation .01 Scope. *COMAR 10.34.01.01* This chapter governs procedures for disciplinary matters and hearings before the Board. #### Regulation .02 Definitions. *COMAR 10.34.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Administrative law judge” means the hearing officer assigned to preside over a hearing in a case that the Board has delegated to the Office of Administrative Hearings under State Government Article, §10-205, Annotated Code of Maryland. (2) “Administrative Procedure Act” means State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, which governs contested cases arising from charges issued by the Board. (3) “Board” means the State Board of Pharmacy. (4) “Case resolution conference” means a voluntary, informal, and confidential meeting between the parties to a contested case and the Board's case resolution conference committee to discuss possible settlement of a disciplinary matter pending before the Board. (5) “Case resolution conference committee” means a committee comprised of one or more members of the Board who make recommendations to the Board regarding settlement of disciplinary matters. (6) “Cease and desist letter” means a public letter issued by the Board ordering: (a) A registrant or licensee to cease doing a specified activity; or (b) An unlicensed person to cease the unauthorized practice of pharmacy or the unauthorized operation of a pharmacy. (7) “Charges” means a nonpublic record issued by the Board which: (a) Alleges conduct by a registrant or licensee that the Board believes constitutes a violation under the Maryland Pharmacy Act; (b) Sets forth sections of the Maryland Pharmacy Act that the Board believes were violated; and (c) Provides notice to the registrant or licensee of disciplinary proceedings before the Board. (8) “Complaint” means an allegation received by the Board that a registrant or licensee may have violated the Maryland Pharmacy Act, and which may be grounds for an investigation or disciplinary action by the Board. (9) “Consent order” means a final order issued by the Board that has been negotiated and agreed to by both the registrant or licensee and the Board to resolve a formal disciplinary action. (10) “Contested case” means a proceeding conducted under the Administrative Procedure Act. (11) “Final order” means a public record issued by the Board resolving a formal disciplinary action by consent or after an adjudication, which: (a) Denies a registration or license; (b) Sanctions by: (i) Reprimand; (ii) Probation; (iii) Fine; or (iv) Suspension or revocation of a registration or license; (c) Summarily suspends a registration or license; (d) Dismisses charges; (e) Surrenders a registration or license; (f) Resolves the contested case by consent of the parties; or (g) Takes any other action that the Board may take by law. (12) “Formal disciplinary action” means action taken by the Board that: (a) Is initiated by: (i) Charges; or (ii) A notice of initial denial; (b) Is resolved by a consent order; (c) Results in a summary suspension; or (d) Results in a letter of surrender. (13) “Informal action” means that the Board closes a case, without formal disciplinary action or issuing a final order, by sending a: (a) Letter of education; (b) Letter of admonishment; or (c) Letter of agreement. (14) “Letter of admonishment” means an informal action taken by the Board consisting of a nonpublic letter closing the case if the Board believes a registrant or licensee engaged in conduct that violated the Maryland Pharmacy Act and may include a letter of agreement in which a registrant or licensee agrees to satisfy certain conditions instead of the Board issuing charges. (15) Letter of Education. (a) “Letter of education” means an informal action consisting of a nonpublic letter: (i) Issued by the Board, closing the case if the Board does not believe that the registrant's or licensee's conduct rose to the level of a violation of the Maryland Pharmacy Act; and (ii) In which the Board educates the registrant or licensee regarding the laws and standards of the practice of pharmacy or operating a pharmacy. (b) “Letter of education” may include a letter of agreement in which a registrant or licensee agrees to satisfy certain conditions. (16) Letter of Surrender. (a) “Letter of surrender” means a public record accepted by the Board in which: (i) The licensee agrees to surrender the licensee's license or permit; or (ii) The registrant agrees to surrender the registrant's registration. (b) “Letter of surrender” may include conditions for the Board's acceptance of the surrender as a resolution of the case. (17) “Licensee” means the holder of a license or permit issued by the Board. (18) “Maryland Pharmacy Act” means Health Occupations Article, Title 12, Annotated Code of Maryland. (19) “Notice of initial denial” means a nonpublic record issued by the Board by which an applicant, registrant, or licensee is notified that the Board intends to: (a) Change a registration or licensure status; (b) Deny a registration, license, or permit; or (c) Deny some other benefit sought by the registrant or licensee. (20) “Party” means the: (a) Respondent or person named or admitted as a party, or properly seeking and entitled as a right to be a party in a formal disciplinary proceeding; or (b) Administrative prosecutor from the Office of the Attorney General presenting a case on behalf of the Board. (21) “Postdeprivation hearing” means a show cause or an evidentiary hearing scheduled by the Board after the Board has issued an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland, in which the registrant or licensee may challenge the Board's basis for issuing the order of summary suspension. (22) “Predeprivation hearing” means a show cause hearing in which the registrant or licensee has an opportunity to demonstrate to the Board why the Board should not: (a) Issue an order for summary suspension under State Government Article, §10-226(c)(2), Annotated Code of Maryland; or (b) Take some other action that the Board may take. (23) “Presiding officer” means the president of the Board or, in the president's absence, a Board member designated by the president, who: (a) Conducts hearings before the Board; and (b) Issues prehearing orders. (24) “Probation” means a sanction imposed by the Board in a public final order under which the registrant or licensee is: (a) Monitored by the Board for a period of time; and (b) Required to comply with certain conditions in order to avoid further disciplinary action. (25) “Public record” means a document that the Board is permitted or required to disclose to the public under State Government Article, Title 10, Subtitle 6, Annotated Code of Maryland. (26) “Recommended decision” means a nonpublic record issued to the Board by an administrative law judge which sets out proposed findings of fact, proposed conclusions of law, a proposed sanction, or any combination of these actions. (27) “Recusal” means the disqualification of a member of the Board to participate in a proceeding because of interest, bias, or some other reason that may interfere with the Board member's participation in the case. (28) “Registrant” means the holder of a: (a) Pharmacy technician registration issued by the Board; or (b) Pharmacy intern registration issued by the Board. (29) “Respondent” means a registrant or licensee subject to the jurisdiction of the Board, who has been: (a) Given formal notice of allegations concerning violations of the Maryland Pharmacy Act; and (b) Notified as to the possible imposition of sanctions or a summary suspension. (30) “Revocation” means the removal of a registrant's registration or licensee's license or permit. (31) “Sanction” means an action by the Board which: (a) Reprimands; (b) Places on probation; (c) Fines; or (d) Suspends or revokes a registration, license, or permit. (32) “Show cause hearing” means a nonevidentiary hearing in which the registrant or licensee may demonstrate to the Board why the Board should not issue a proposed order or continue to take an action that the Board may take. (33) “Summary suspension” means the indefinite suspension of a registration or license under State Government Article, §10-226(c)(2), Annotated Code of Maryland, issued if the Board believes emergency action is necessary to protect the public health, safety, or welfare. (34) “Suspension” means the temporary denial of the right to use a registration, license, or permit and is usually defined by: (a) A specified period of time; (b) Specific dates; or (c) Specific conditions. #### Regulation .03 Confidentiality of Proceedings. *COMAR 10.34.01.03* A. Except as otherwise provided by law, the proceedings of the Board are confidential and that confidentiality may not be waived by the parties. B. The Office of Administrative Hearings' proceedings involving the adjudication of a Board formal disciplinary action and the administrative law judge's recommended decision are confidential. C. The respondent may not waive the confidentiality of the: (1) Proceedings; or (2) Patients whose medical records or care are reflected in the record of the proceedings. D. To the extent possible, even after the close of a formal disciplinary action, the parties shall refrain from revealing: (1) Legal documents; (2) Oral statements; or (3) Information that would reveal the identity of patients involved in the matter. #### Regulation .04 Representation by Counsel. *COMAR 10.34.01.04* A. A respondent may be represented by counsel at any stage of a formal disciplinary action. B. If a hearing is held on a matter, the respondent shall be represented: (1) In proper person; or (2) By an attorney who has been: (a) Admitted to the Maryland Bar; or (b) Specially admitted to practice law under Maryland Rules, Rules Governing Admission to the Bar of Maryland, Rule 14, Annotated Code of Maryland. C. The Board may request the Office of the Attorney General to participate in a hearing to present the case on behalf of the State. D. The member of the Office of the Attorney General presenting the case on behalf of the State has the same rights as any party with regard to: (1) Submission of evidence, examination, and cross-examination of witnesses; and (2) The filing of objections, exceptions, and motions. E. The Board may request a member of the Office of the Attorney General to act as legal advisor to the Board on questions of: (1) Procedure; (2) Evidence; and (3) Law. #### Regulation .05 Disposition of Complaints. *COMAR 10.34.01.05* A. For each complaint, after reviewing any completed investigative information or reports, the Board shall: (1) Dismiss the complaint; (2) Close the case with informal action; (3) Issue a cease and desist order; (4) Refer the matter for further investigation; (5) Refer the matter to an administrative prosecutor; or (6) Vote to: (a) Charge a registrant or licensee with a violation of the Maryland Pharmacy Act; (b) Consider the matter as a basis for a summary suspension; (c) Initially deny a registration, license, or permit or reinstatement of a registration, license, or permit; or (d) Accept the surrender of a registration, license, or permit subject to conditions acceptable to the Board. B. The Board may refer a complaint or other disciplinary matter to the administrative prosecutor at any time, whether or not the Board has voted to charge a registrant or licensee with violations of the Maryland Pharmacy Act. #### Regulation .06 Notice of Charges or Notice of Initial Denial. *COMAR 10.34.01.06* A. If the Board issues charges or a notice of initial denial, the document shall be: (1) Served on the respondent by certified mail at the address the respondent is required to maintain with the Board; or (2) Hand delivered in person. B. Charges or notice of initial denial shall: (1) Inform the respondent of the statutory basis for the charges or denial of a registration, license, or permit; (2) Allege sufficient facts that the Board believes constitute a basis for: (a) Violation of the Maryland Pharmacy Act; or (b) Denial of a registration, license, or permit; and (3) Include the notice of hearing. C. If the Board issues a notice of initial denial to an applicant for a registration or license, the applicant may not withdraw the application without approval from the Board. #### Regulation .07 Notice of Hearing. *COMAR 10.34.01.07* A. Except for a show cause hearing, written notice of hearings shall be sent by the Executive Director or an officer of the Board to the parties at least 20 days before the hearing. B. The Board shall serve the notice of hearing by: (1) Certified mail at the address the respondent is required to maintain with the Board; or (2) Hand delivery in person. C. The notice of hearing shall state, if applicable: (1) The date, time, place, and nature of the hearing; (2) The right to: (a) Representation; (b) Call witnesses; (c) Submit documents or other relevant evidence; (d) Request subpoenas for witnesses and evidence and the costs associated with such a request; (3) That a failure to appear for the scheduled hearing may result in an adverse action against the party; and (4) That the parties may agree to the evidence and waive their right to appear at the hearing. D. The notice of hearing may include: (1) Deadlines for: (a) Discovery; and (b) Motions; and (2) Dates for the: (a) Prehearing conference; and (b) Case resolution conference. #### Regulation .08 Prehearing Conferences and Case Resolution Conferences. *COMAR 10.34.01.08* A. The Board may set a prehearing conference or a case resolution conference, or both. B. The prehearing conference may be used to prepare for the hearing by: (1) Delineating the issues; (2) Stipulating to: (a) Facts; (b) Laws; and (c) Other matters; (3) Arranging a schedule for the: (a) Exchange of documents and witness information; and (b) Submission of motions and responses to motions; or (4) Addressing other matters that will promote the orderly and efficient conduct of the hearing. C. Prehearing Orders. (1) If a prehearing conference has been held, a prehearing order may be issued by the presiding officer. (2) The prehearing order shall set forth the actions taken or to be taken with regard to any matter addressed at the prehearing conference. (3) If a prehearing conference is not held, the presiding officer may issue a prehearing order to regulate the conduct of the proceedings. (4) Absent an exception from the presiding officer, the prehearing order shall be binding on the parties. D. The Case Resolution Conference. (1) Matters admitted, revealed, negotiated, or otherwise discussed are without prejudice and may not be used by the respondent, administrative prosecutor, or the Board in subsequent proceedings, unless the information is otherwise discoverable or available through another source. (2) The Board is not bound by the recommendations of the case resolution conference committee and may: (a) Modify the proposed settlement; (b) Require additional conditions; or (c) Reject the recommendation and require the respondent to proceed to a hearing. (3) If the respondent disagrees with the recommendation of the case resolution conference committee, the respondent may elect to proceed to a hearing on the matter, regardless of whether the Board has ratified the recommendation of the case resolution conference committee. (4) Participation in a case resolution conference is not a basis for recusal of a Board member, Board counsel, or Board prosecutor from further proceedings. E. Motions. (1) Unless otherwise set forth in a prehearing order or notice of hearing, motions shall be: (a) Accompanied by a memorandum of points and authorities; and (b) Filed with the Board at least 15 working days before the hearing. (2) A copy of a motion filed with the Board shall be served on the opposing party by the party filing the motion. (3) A response shall be filed with the Board at least 10 working days before the hearing and a copy served on the opposing party. (4) The Board may refuse to consider a motion or response that is not timely filed. #### Regulation .09 Discovery. *COMAR 10.34.01.09* A. Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, as appropriate, a party may require another party to produce, within 15 days, the following: (1) A list of witnesses to be called; (2) Copies of documents intended to be produced at the hearing; or (3) Both §A(1) and (2) of this regulation. B. Mandatory Discovery. (1) Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier: (a) The name and curriculum vitae of any expert witness who will testify at the hearing; and (b) A detailed written report summarizing the expert's testimony, which includes the: (i) Opinion offered; (ii) Factual basis for the opinion; and (iii) Reasons underlying the opinion. (2) If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of §B(1) of this regulation, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert. (3) The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report: (a) At the prehearing conference, if scheduled; or (b) Immediately before the scheduled hearing. (4) If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in §B(1) of this regulation. C. Parties are not entitled to discovery of items other than as listed in §§A and B of this regulation. D. Both parties have a continuing duty to supplement their disclosure of witnesses and documents. E. Absent unforeseen circumstances that would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list: (1) After the prehearing conference, if scheduled; or (2) Later than 15 days before the hearing, if no prehearing conference is scheduled. F. The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes. G. Construction. (1) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01. (2) In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies. #### Regulation .10 Evidentiary Hearings. *COMAR 10.34.01.10* A. Hearings shall be conducted under the Administrative Procedure Act. B. The Board may delegate its authority to conduct hearings to the Office of Administrative Hearings. C. Hearings are not open to the public. D. Records, including the recommended decision, shall be treated as confidential and sealed. E. Records. (1) The Board shall prepare an official record of hearings that shall include all: (a) Pleadings; (b) Testimony; (c) Exhibits; and (d) Other memoranda or material filed in the proceeding. (2) Unless waived by all parties, a stenographic record of the proceedings shall be made at the expense of the Board. (3) The stenographic record may not be transcribed, unless requested by a party or by the Board. (4) The cost of transcribing all or part of a proceeding, shall be paid by the party requesting the typewritten transcript. F. Quorum. (1) A majority of the members serving on the Board is a quorum of the Board. (2) Hearings shall be held before a quorum of the Board. G. Presiding Officer. (1) The presiding officer shall: (a) Conduct a full, fair, and impartial hearing; (b) Take action to avoid unnecessary delay in the disposition of the proceedings; (c) Maintain order; and (d) Adjourn or recess the hearing from time to time. (2) The presiding officer may regulate the course of the hearing and the conduct of the parties, including the authority to: (a) Permit the examination of witnesses; (b) Rule on offers of proof and admit relevant and material evidence; (c) Consider and rule on motions; (d) Grant a continuance or postponement; (e) Determine the order in which the parties shall present their cases; (f) Limit unduly repetitious testimony; (g) Reasonably limit the time for presentation; and (h) Issue orders necessary to: (i) Secure procedural simplicity and administrative fairness; and (ii) Eliminate unjustifiable expense and delay. H. Examination of Witnesses and Introduction of Evidence. (1) The rules of evidence in State Government Article, §10-213, Annotated Code of Maryland apply to hearings before the Board. (2) A party may: (a) Submit evidence; (b) Examine and cross-examine witnesses; and (c) File objections, exceptions, and motions. (3) If a party is represented by counsel, submission of evidence, examination and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by the counsel. (4) The presiding officer, or a person designated by the presiding officer for that purpose, may examine a witness called by a party. (5) The presiding officer may call as a witness a person necessary to ensure a full and complete record. (6) Any Board member may examine any witness. I. Briefs. (1) A party may submit a brief on the issues of fact and law involved in the hearing. (2) The presiding officer may designate: (a) The form of the brief; (b) The number of copies to be submitted; and (c) The date and time of submission. (3) The Board may refuse to consider a brief that is not timely filed or fails to conform to requirements imposed by the presiding officer. J. If a party who is the respondent in the proceedings fails to appear at a hearing after due notice, the Board may: (1) Reschedule the hearing; or (2) In the Board's discretion, proceed upon the investigation, report, documents, witnesses, and records before it. K. The Board shall take testimony under oath. L. Decision and Order. (1) A decision and order rendered by the Board shall: (a) Be in writing; and (b) Include the findings of fact and conclusions of law. (2) A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or the party's attorney of record. (3) The findings of fact, conclusions of law, and order referred to in §L of this regulation shall be retained as a permanent record by the Board. M. A party aggrieved by a final decision of the Board under Health Occupations Article, §12-313, Annotated Code of Maryland, may seek judicial review of the Board's decision. N. The review referenced in §M shall be in accordance with State Government Article, §§10-222 — 10-223, Annotated Code of Maryland. O. Rehearings. (1) Within 10 days after service on a party of the decision of the Board, the party may apply to the Board for rehearing. (2) The application shall state the grounds for rehearing. (3) The Board shall grant or deny the application within 20 days of submission to the Board. (4) Unless otherwise ordered, neither the rehearing nor the application for rehearing shall: (a) Stay the enforcement of the order; or (b) Excuse the persons affected by the order for failure to comply with the terms of the order. (5) At a rehearing, the Board shall only consider facts not presented in the original proceeding, including facts arising after the date of the original proceeding. (6) By new order, the Board may abrogate, change, or modify its original order. #### Regulation .11 Exceptions Hearings. *COMAR 10.34.01.11* A. If a case has been delegated to the Office of Administrative Hearings under State Government Article, §10-205, Annotated Code of Maryland, for proposed findings of fact, conclusions of law, and disposition, a party may file exceptions with the Board within 30 days of receipt of the recommended decision. B. The opposing party to the exceptions shall respond within 15 days of receipt of the exceptions. C. If a party files exceptions, the Board shall schedule a hearing to be held before a quorum of the Board. D. The exceptions hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the exceptions to the recommended decision. E. The Board shall: (1) Consider: (a) The exceptions; (b) Responses to exceptions; and (c) The record in the case; and (2) Issue an order containing accepted findings of fact, conclusions of law, and disposition. F. The presiding officer: (1) Shall determine procedural issues governed by this regulation; and (2) May: (a) Impose reasonable time limitations; and (b) Make rulings reasonably necessary to facilitate the effective and efficient operation of the exceptions hearing. G. If the parties do not file timely exceptions, a quorum of the Board shall: (1) Consider the recommended decision from the Office of Administrative Hearings; and (2) Issue an order based on the: (a) Board's accepted findings of fact and conclusions of law; and (b) The record of the case. #### Regulation .12 Summary Suspensions. *COMAR 10.34.01.12* A. The Board shall order the summary suspension of a registration, license, or permit if the Board determines that there is a substantial likelihood that a registrant or licensee poses a risk of harm to the public health, safety, or welfare. B. Based on information gathered in an investigation or otherwise provided to the Board, the Board may vote to issue: (1) A notice of an intent to summarily suspend a registration, license, or permit; or (2) An order of summary suspension. C. If the Board votes to issue a notice of intent to summarily suspend a registration, license, or permit or an order of summary suspension, the Board shall refer the matter to an administrative prosecutor for prosecution. D. Service of the notice of intent to summarily suspend a registration, license, or permit shall be made by: (1) Hand delivery in person; (2) Certified mail to the address the respondent is required to maintain with the Board; or (3) Other reasonable means to effect service. E. Notice of Intent to Summarily Suspend. (1) A notice of intent to summarily suspend a registration, license, or permit shall include: (a) A proposed order of summary suspension which is unexecuted by the Board and which includes: (i) The statutory authority on which the action has been taken; (ii) Allegations of fact which the Board believes demonstrate a substantial likelihood that the registrant or licensee poses a risk of harm to the public health, safety, or welfare; and (iii) Notice to the respondent of the right to request an evidentiary hearing of the summary suspension if the Board executes the proposed order of summary suspension; and (b) An order or summons to appear before the Board: (i) To show cause why the Board should not execute the order of summary suspension; and (ii) Which notifies the respondent of the consequences of failing to appear. (2) Predeprivation Hearing. (a) If the Board issues a notice of intent to summarily suspend a registration, license, or permit, the Board shall offer the respondent the opportunity to appear before the Board to show cause why the respondent's registration, license, or permit should not be summarily suspended. (b) The show cause hearing shall be a nonevidentiary hearing to provide the parties with an opportunity for oral argument on the proposed summary suspension. (c) The presiding officer: (i) Shall determine procedural issues; (ii) May impose reasonable time limits on each party's oral argument; and (iii) Shall make rulings reasonably necessary to facilitate the effective and efficient operation of the show cause hearing. F. Order of Summary Suspension. (1) The Board may order the summary suspension of a registration, license, or permit without first issuing a notice of intent to summarily suspend or providing a respondent with a predeprivation hearing if the Board determines that the threat to public health, safety, and welfare requires the immediate suspension of the registration, license, or permit. (2) Postdeprivation Hearing. (a) The respondent shall be provided with a show cause hearing within a reasonable time after the effective date of the order of summary suspension. (b) The show cause hearing under §F(2)(a) of this regulation shall: (i) Be conducted before the Board as provided in §E(2) of this regulation; and (ii) Provide the respondent with an opportunity to show cause why the Board should lift the summary suspension. (3) After the show cause hearing, if the Board votes to continue the summary suspension, the respondent may request an evidentiary hearing before the Board. (4) An evidentiary hearing: (a) May be consolidated with a hearing on charges issued by the Board that include the facts that form the basis for the summary suspension; and (b) Shall be conducted under the Administrative Procedure Act. G. Disposition. (1) If the Board issues a notice of intent to summarily suspend a registration, license, or permit, the Board may, after the show cause hearing, vote to: (a) Order a summary suspension; (b) Deny the summary suspension; (c) Enter into a consent order; or (d) Enter into any interim order warranted by the circumstances of the case, including one providing for the stay of the summary suspension subject to certain conditions. (2) If the Board orders a summary suspension before a show cause hearing, the Board may, at the conclusion of the show cause hearing, vote to: (a) Affirm the order of summary suspension; (b) Rescind the order of summary suspension; (c) Enter into a consent order; or (d) Enter into an interim order warranted by the circumstances of the case, including one providing for a stay of the summary suspension subject to certain conditions. (3) An order for summary suspension or any other order of the Board issued after the initiation of summary suspension proceedings is a: (a) Final order of the Board; and (b) Public record. #### Regulation .13 Surrender of a Registration, License, or Permit. *COMAR 10.34.01.13* A. The Board may: (1) Accept the surrender of a registration, license, or permit; (2) Require conditions for surrender of a registration, license, or permit, including: (a) The admission of a violation of the Maryland Pharmacy Act; (b) The admission of facts; (c) A statement of the circumstances under which the surrender was offered or accepted; (d) Restrictions on future registration, licensing, or permit; (e) Conditions for reinstatement of the registration, license, or permit; or (f) An agreement that the respondent may not again apply for a registration, license, or permit. B. A letter of surrender is a final order of the Board and is a public record. #### Regulation .14 Probation and Violation of Probation. *COMAR 10.34.01.14* A. If the Board imposes a period of probation as a sanction, the Board may impose conditions of probation that the Board considers appropriate, including: (1) Re-education or completion of approved courses; (2) Payment of a fine; (3) Practicing pharmacy or operating a pharmacy under supervision; (4) Monitoring by the Board or by an individual or entity approved by the Board with periodic reporting to the Board; (5) Periodic review of a licensee's practice or operations; (6) Periodic audits of a licensee's billing practice; (7) An examination by a physician or other appropriate health care provider; (8) Limitation of the licensee's practice or operations; (9) Limitation of the pharmacy technician's scope of duties; (10) Drug screenings; (11) Individual or group counseling or therapy; (12) Obtaining a passing score on an appropriate examination; or (13) Any other condition the Board considers appropriate for the rehabilitation or retraining of a registrant or a licensee. B. A term of probation may be defined by a specific period of time or the successful completion of certain conditions or acts by the registrant or licensee. C. A registrant or licensee seeking release from probation shall do so by petitioning the Board to terminate the probation when the: (1) Specific period of time has passed; or (2) Registrant or licensee has successfully completed the conditions or acts required for release. D. If, at any time, the Board has reason to believe that the registrant or licensee is not in compliance with the conditions of probation, the Board shall: (1) Charge the registrant or licensee with a violation of probation; (2) Take an action provided for in the final order in the event of a violation of probation, including suspension of the registration, license, or permit; (3) Consider a summary suspension of the registration, license, or permit; or (4) Take any other action the Board considers appropriate and which the Board may take by law. E. If the Board determines that the respondent has violated probation, the Board shall: (1) Take an action provided for in the final order in the event of a violation of probation; (2) Impose additional conditions or probation; or (3) Impose a sanction or take any other action that the Board considers appropriate and may take by law. #### Regulation .15 Reinstatement. *COMAR 10.34.01.15* A. A registrant or licensee shall petition the Board for a lifting of the suspension of a registration, license, or permit or a reinstatement following revocation or surrender of a registration, license, or permit. B. The Board may reinstate a registration, license, or permit in accordance with: (1) The terms and conditions of the order of revocation or suspension; (2) A letter of surrender; (3) An order of reinstatement issued by the Board; or (4) A final judgment in any proceeding for judicial review. C. If not otherwise specified in a document under §B of this regulation, the licensee shall meet the requirements of COMAR 10.34.13 to reinstate a license or permit. C-1. If not otherwise specified in a document under §B of this regulation, the registrant shall meet the requirements of COMAR 10.34.34 to reinstate a registration. D. If a time period is not specified in the Board's final order, a petition for reinstatement may not be considered by the Board before the expiration of 1 year after the date of the order. E. The form of a reinstated registration, license, or permit shall: (1) Be similar in every respect to an original registration, license, or permit; and (2) Bear the new date of issue. F. If the Board grants reinstatement of a registration, license, or permit, it may impose any restrictions or conditions on the registration, license, or the licensee's practice that it considers appropriate. G. The Board may reinstate the license of an individual whose license has been revoked under Criminal Law Article, §5-702, Annotated Code of Maryland, if: (1) The individual has petitioned the Board for reinstatement; (2) The petition for reinstatement is made to the Board after the expiration of 5 years after the revocation; (3) The individual has met the requirements of COMAR 10.34.13 to reinstate a license; and (4) The individual has made restitution to aggrieved persons that may have resulted from a violation and conviction of Criminal Law Article, §5-702, Annotated Code of Maryland. ### Chapter 02 — Examination for Licensure and Professional Experience Programs **Authority:** Health Occupations Article, §§12-205 and 12-302, Annotated Code of Maryland **Administrative History:** Effective date: August 6, 1975 (2:17 Md. R. 1188) **Administrative History:** Regulation .02 adopted effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulation .02B amended effective November 1, 1994 (21:14 Md. R. 1229); November 3, 1997 (24:22 Md. R. 1551) **Administrative History:** Regulations .02—.05 recodified as Regulations .03—.06 effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulation .03 amended effective April 9, 1984 (11:7 Md. R. 625); February 19, 1990 (17:3 Md. R. 298); November 1, 1994 (21:14 Md. R. 1229); November 3, 1997 (24:22 Md. R. 1551) **Administrative History:** Regulation .04 amended effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .05A, B amended effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Chapter revised effective February 17, 2003 (30:3 Md. R. 180) **Administrative History:** Regulation .02B amended effective March 2, 2026 (53:4 Md. R. 185) **Administrative History:** Regulation .03 amended effective June 20, 2005 (32:12 Md. R. 1047; March 2, 2026 (53:4 Md. R. 185) **Administrative History:** Regulation .03D amended effective July 3, 2017 (44:13 Md. R. 621) **Administrative History:** Regulation .04 amended effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .05A, D amended effective July 1, 2015 (42:7 Md. R. 569) #### Regulation .01 Scope. *COMAR 10.34.02.01* This chapter applies to: A. Applicants for licensure as a pharmacist; and B. Internship programs for student pharmacists for which credit may be allowed toward licensure. #### Regulation .02 Definitions. *COMAR 10.34.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Foreign school or college of pharmacy” means a school or college of pharmacy that is not located in any state of the United States. (3) “Licensure examinations” means the Board-administered or Board-approved examinations required of applicants for licensure which include the following: (a) Exam I: North American Pharmacist Licensure Examination (NAPLEX); (i) Part I: NAPLEX, and (ii) Part II: Pharmacy Law Test; (b) Exam II: Pharmacy Law Test through either: (i) The Uniform Multistate Pharmacy Jurisprudence Examination (UMPJE) and the Maryland Pharmacy Law webinar and post-webinar test; or (ii) The Maryland Multistate Pharmacy Jurisprudence Examination (MPJE); and (c) Exam III: (i) Prescreening Test of Oral English Competency; or (ii) Test of Oral English Competency. #### Regulation .03 Licensure Examinations. *COMAR 10.34.02.03* A. Examination Eligibility. (1) An applicant may be approved by the Board to take Exam I upon satisfactory proof that the applicant has graduated, or is expected to graduate at the completion of the immediate semester, from a school or college of pharmacy that has been: (a) Approved by the Board; or (b) Accredited by the American Council on Pharmaceutical Education (ACPE). (2) Beginning May 1, 2027, an applicant may be approved by the Board to take Exam II upon satisfactory proof that the applicant has graduated from, or has successfully completed the didactic portion of the core curriculum of a school or college of pharmacy that has been: (a) Approved by the Board; or (b) Accredited by the American Council on Pharmaceutical Education (ACPE). B. An applicant may not receive a license until the applicant has: (1) Obtained passing scores on Exam I, Exam II, and Exam III, as applicable; and (2) Provided satisfactory proof to the Board of the applicant’s graduation from a college or school of pharmacy approved by the Board or accredited by the American Council on Pharmaceutical Education (ACPE). C. Passing Scores—Exam I and Exam II. (1) The passing score for Exam I is 75. (2) II Passing Scores. (a) For the Maryland Multistate Pharmacy Jurisprudence Examination (MPJE) the passing score is 75. (b) For the Uniform Multistate Pharmacy Jurisprudence Examination (UMPJE) the passing score is 75. (c) Maryland Pharmacy Law Webinar and Post-Webinar Exam. (i) The passing score is 85. (ii) The Maryland Pharmacy Law webinar and post-webinar exam shall provide unlimited attempts to pass the exam in one sitting provided that the applicant reviews the webinar after each failed attempt at the exam. (iii) There may not be a fee associated with the Maryland Pharmacy Law webinar and post-webinar exam. (3) If a candidate receives a passing score on Exam I or Exam II, the candidate is not required to retake that exam unless the passing score was received more than 2 years before the date the candidate successfully completed all of the other examination requirements set forth in this regulation. D. Passing Score—Exam III. (1) Prescreening Test of Oral English Competency. (a) On completion of a prescreening test application form provided by the Board, an applicant may elect to take a standardized prescreening test of oral English competency given by the Board's agents at times to be determined by the Board. (b) An agent of the Board possessing post-secondary credentials in an academic discipline acceptable to the Board shall score the prescreening test of oral English competency through the use of a standardized rating system. (c) An agent of the Board shall design the rating system of the prescreening test so that a passing score demonstrates that an applicant speaks fluent English as proficiently as typical United States native speakers whose English is easily understood by the average pharmacy patient or customer. (d) By choosing to take the prescreening test of oral English competency, an applicant is certifying to the Board that the applicant speaks English as proficiently as typical United States native speakers whose English is easily understood by the average pharmacy patient or customer. (e) By choosing to take the prescreening test to verify this certification, the applicant consents to pay the costs of test administration and shall pay the fee indicated on the Board's prescreening application form directly to the Board's agent. (f) An applicant who passes the prescreening test passes Exam II, the Test of Oral English Competency required under Regulation .02B(2)(b) of this chapter. (g) An applicant who fails the prescreening test for oral English competency may take the Test of Oral English Competency required under Regulation .02B(2)(b) of this chapter without prejudice to the applicant's licensure application if the applicant pays all related fees. (h) An applicant who has graduated from a recognized English-speaking professional school accredited by the Accreditation Council for Pharmacy Education is deemed to be proficient in the oral communication of the English language in satisfaction of requirements of the prescreening test. (2) Test of Oral English Competency. (a) In order to obtain a license to practice pharmacy, an applicant shall pass a standardized test of oral English competency approved by the Board or the board of pharmacy of another state with a score acceptable to the Board, based upon the Board's standards and the examination taken. (b) The Board shall provide the applicant with a list of Board-approved testing services and the passing score for each approved test of oral English competency. (c) Waiver. The Board shall waive the requirement as set forth under §D(2)(a) of this regulation if the applicant graduated from a recognized English-speaking professional school accredited by the Accreditation Council for Pharmacy Education. (3) Claims of Speech Impairment. (a) An applicant who claims to have a speech impairment shall submit documentation of the impairment on forms supplied by the Board and completed by a Board-approved: (i) Licensed physician; and (ii) Speech-language pathologist licensed to practice speech pathology in the United States. (b) The applicant shall submit the documentation with: (i) The applicant's initial application; or (ii) Before the applicant's second attempt at passing the test of oral English competency. (c) After the second examination, the applicant may not submit documentation of impairment unless: (i) An intervening medical or surgical event caused the impairment; (ii) The applicant claims the impairment before a third examination; and (iii) The applicant provides documentation that is approved by the Board. (d) The Board may accept documentation of a speech impairment as a passing score on Exam II if the applicant also: (i) Provides documentation from a Board-approved licensed pharmacist or a Board-approved instructor in a school of pharmacy that the applicant can communicate in a professionally competent manner with patients and health care providers; and (ii) Describes, in a hearing before the Board, the manner in which the applicant would communicate with a licensed prescriber regarding a prescription and would counsel a typical patient on proper drug usage. (4) The certifying or verifying authority shall send all certificates and verifications directly to the Board for the applicants. (5) The Board-approved testing services may not accept certificates and verifications sent to or by the applicant. (6) If any of the documents required under this regulation are in a language other than English, the certifying or verifying authority shall submit a certified translation. (7) The applicant shall bear the costs of: (a) Translation by a certified translator; (b) Taking the test of oral English competency; and (c) Obtaining documents required under this regulation. E. Graduates of a Foreign School or College of Pharmacy. (1) In addition to the other examination requirements set forth in this regulation, an applicant who has graduated from a foreign school or college of pharmacy shall: (a) Be approved to take the Foreign Pharmacy Graduate Equivalency Examination (FPGEE); and (b) Obtain the Foreign Pharmacy Graduate Education Committee (FPGEC) Certificate. (2) The passing score for the FPGEE is 75. (3) Upon successful completion of the FPGEE and submission of the FPGE Certificate, an applicant may be approved by the Board to take Exam I and Exam II. #### Regulation .04 Internship Program or Training Required. *COMAR 10.34.02.04* An applicant shall complete one of the following as a prerequisite to Board licensure: A. 1,000 hours of a school-supervised professional experience program conducted by a school of pharmacy accredited by the American Council of Pharmaceutical Education; or B. 1,560 hours of full-time training, as a registered pharmacy intern under the direct supervision of licensed pharmacists pursuant to Regulation .05 of this chapter as an applicant who: (1) Has graduated from a foreign school of pharmacy; or (2) Does not meet the requirements of §A of this regulation. C. An applicant may receive credit for any of the 1,560 hours earned up to 10 months before the effective date of this regulation. #### Regulation .05 Partial or Non-Pharmacy-School-Supervised Program of Internship. *COMAR 10.34.02.05* A. Applicants may complete the requirement for internship training by having at least 1,560 hours of full-time training as a registered pharmacy intern, under the direct supervision of licensed pharmacists. B. The licensed pharmacists providing direct supervision shall be approved by the Board. C. The applicant shall present evidence satisfactory to the Board that the applicant has completed the training under this regulation, validated by the supervising pharmacist or pharmacists. D. If an approved school or college of pharmacy offers a partial fulfillment of internship requirements as a part of its curriculum, time spent in a program by an applicant may be accepted by the Board on an equivalent basis to replace a portion of the required 1,560-hour internship pharmacy internship training under this regulation. ### Chapter 03 — Institutional Pharmacy **Authority:** Health Occupations Article, §12-205, Annotated Code of Maryland **Administrative History:** Effective date: November 6, 1995 (22:22 Md. R. 1666) **Administrative History:** Chapter revised effective October 1, 2011 (38:19 Md. R. 1147) **Administrative History:** Regulation .02B amended effective May 31, 2014 (40:19 Md. R. 1547) **Administrative History:** Regulation .03 amended effective May 31, 2014 (40:19 Md. R. 1547) **Administrative History:** Regulation .06C amended effective May 31, 2014 (40:19 Md. R. 1547) **Administrative History:** Regulation .12B amended effective May 31, 2014 (40:19 Md. R. 1547) **Administrative History:** Regulation .17 adopted effective May 31, 2014 (40:19 Md. R. 1547) #### Regulation .01 Scope. *COMAR 10.34.03.01* This chapter applies to: A. A permit holder that operates a pharmacy that services an inpatient setting; and B. A person or entity that holds a pharmacy permit and operates a pharmacy in or for an institutional facility. #### Regulation .02 Definitions. *COMAR 10.34.03.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Decentralized pharmacy” means an institutional pharmacy which provides services for the population of an institutional facility and is: (a) Dependent on another institutional pharmacy for: (i) Administrative control; (ii) Staffing with a licensed pharmacist physically available on site in the decentralized pharmacy to supervise the performance of delegated pharmacy acts; and (iii) Drug procurement; and (b) Located in the same building or pavilion as the other institutional pharmacy. (1-1) “Direct supervision” means that a licensed pharmacist is physically available to supervise the performance of delegated pharmacy acts. (1-2) “Director of pharmacy” means a pharmacist who is responsible for the pharmacy services provided by an institutional pharmacy in compliance with appropriate State and federal laws and regulations. (2) “Dispense” or “dispensing” means the procedure which results in the receipt of a prescription or nonprescription drug or device by a patient or the patient’s agent and which entails the: (a) Interpretation of an authorized prescriber’s prescription for a drug or device; (b) Selection and labeling of the drug or device prescribed pursuant to that prescription; and (c) Measuring and packaging of the prescribed drug or device in accordance with State and federal laws. (3) Distribute. (a) “Distribute” means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under Health Occupations Article, Title 12, Annotated Code of Maryland, prior to administration of the provided drug or device to the patient pursuant to a prescription issued by an authorized prescriber. (b) “Distribute” does not include the operations of a person who holds a permit issued under Health Occupations Article, §12–6C–03, Annotated Code of Maryland. (4) “Drug” means a prescription or non-prescription medication or other material used in the diagnosis or treatment of injury, illness, or disease. (5) “Drug recall” means the recall of a drug by a manufacturer or the U.S. Food and Drug Administration (FDA) in the event that there is a reasonable possibility that the use of or exposure to an affected product may cause either: (a) Adverse effects on health; or (b) Death. (6) “Emergency drug supply” means a process for supplying drugs which: (a) May be required for the emergency need of a patient; and (b) Is not available from an authorized source in a timely manner. (7) “Institutional facility” or “institution” means an entity other than a comprehensive care facility, assisted living facility, developmental disabilities facility, or correctional facility whose primary purpose is to provide a physical environment for patients to obtain inpatient, outpatient, or emergency care, except for urgent care facilities that are not part of an institution. (8) “Institutional medication protocol” means a course of therapy including drug treatment predetermined and documented by the institution and the generally accepted medical practice for proper completion of a particular therapeutic or diagnostic intervention ordered by an authorized prescriber and which allows the pharmacist to execute the protocol. (9) “Institutional pharmacy” means a pharmacy which: (a) Provides services to an acute care, rehabilitation, transitional care, chronic care, or mental health hospital; (b) Engages in compounding, distributing, or dispensing of drugs; (c) May provide nondispensing functions as described in Regulation .16 of this chapter; and (d) Has been issued a pharmacy permit pursuant to Health Occupations Article, §§12-401 and 12-403(c), Annotated Code of Maryland. (10) “Licensed pharmacist” means an individual who is licensed by the Board to practice pharmacy. (11) “Medication order” means a patient-specific order entered on the chart or a medical record of a patient by an authorized prescriber or the authorized prescriber’s designee for a drug or device that is transmitted in writing, verbally or by electronic means and includes the: (a) Date ordered; (b) Drug name; (c) Dosage; (d) Dosage form; (e) Patient name with second identifier such as date of birth or medical record number; (f) Route of administration; (g) Administration instructions, if appropriate; and (h) Signature, if appropriate, of an: (i) Authorized prescriber, as defined in Health Occupations Article, §12-101(b), Annotated Code of Maryland; or (ii) Individual permitted to practice medicine without a license as defined in Health Occupations Article, §14-302, Annotated Code of Maryland. (12) “Order-sets” means predefined orders, including medication orders, that are based on an institutionally approved protocol. (12-1) “Pavilion” means a detached or semidetached part of a hospital devoted to a special use. (13) Pharmaceutical care. (a) “Pharmaceutical care” means the provision of a patient’s drug regimen for the purpose of: (i) Achieving definite outcomes related to the cure or prevention of a disease; (ii) Elimination or reduction of a patient’s symptoms; or (iii) Arresting or slowing of a disease process by identifying, resolving, or preventing actual or potential drug therapy problems. (b) “Pharmaceutical care” may include patient counseling and providing information to licensed and certified health care providers. (14) “Prescription Drug. (a) “Prescription drug” means any drug required by federal law or regulation to be dispensed only by a prescription. (b) “Prescription drug” includes: (i) A biological product; and (ii) Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug and Cosmetic Act. (c) “Prescription drug” does not include blood and blood components intended for transfusion or biological products that are also medical devices. (15) “Second identifier” means a reliable method to: (a) Identify a patient for whom service or treatment is intended; and (b) Match the service or treatment intended to the patient. (16) “Verbal order” means a medication order from an authorized prescriber which is received by an authorized licensed practitioner using appropriate read back procedures that is subsequently recorded in the patient’s chart and countersigned by the prescriber within a time period required by the institution. (17) “Written order” means a medication order that is recorded as a written document by an authorized prescriber. #### Regulation .03 Issuance of Permits. *COMAR 10.34.03.03* A. An institutional pharmacy shall obtain required permits in compliance with State and federal laws and regulations. B. An institutional pharmacy shall: (1) Staff a pharmacist at each decentralized pharmacy site within the building or pavilion in which it is located; and (2) List decentralized pharmacy sites within the building in which it is located, on the initial application, or on the renewal application; C. A decentralized pharmacy that meets the definition as set forth in this chapter may operate under the same permit as the institutional pharmacy located in the same building or pavilion. D. If full service pharmacy services are provided to discharge patients, employees, clinic patients, or others, an institutional pharmacy shall obtain a full service pharmacy permit. E. Any other pharmacy that does not meet the requirements of a decentralized pharmacy and is located on the campus or affiliated with an institutional pharmacy shall be separately licensed. #### Regulation .04 Policies and Procedures. *COMAR 10.34.03.04* A. The director of pharmacy shall establish and operate under a policies and procedures manual which: (1) Complies with this chapter; (2) Defines the scope and method of pharmacy services provided to the patients of the institutional facility; (3) Determines when personnel may have access to the pharmacy area; (4) Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle; (5) Includes: (a) Labeling requirements that meet the requirements of this chapter; (b) Distribution methods for medication that assures that a patient receives the correct dose ordered by the prescriber; (c) Packaging methods that assure the medication is appropriately identified, designed to maintain stability until expiration and traceable throughout the distribution chain to facilitate recall; (d) Distribution methods that provide for safe handling of medications that may be manual or computerized employing centralized, decentralized, or remote devices that meet the requirements of COMAR 10.34.28. (e) Pharmacy security methods that comply with this chapter; (f) Conditions in which an emergency drug supply may be replenished or prepared, delivered, and stored by the institutional facility; (g) Duties that may be performed by a licensed pharmacist, registered pharmacy technician and unlicensed personnel; and (h) Methods for proper disposal of pharmaceuticals as required by State and federal law; (6) Is provided to: (a) The personnel of the pharmacy; (b) The institutional facility; and (c) Upon request, an agent of the Board; and (7) Is in a form that is: (a) Written or electronic; and (b) Readily retrievable; B. The director of pharmacy shall provide annual training on the policies and procedures manual to the personnel of the pharmacy. #### Regulation .05 Personnel. *COMAR 10.34.03.05* A. The permit holder shall appoint a licensed pharmacist as director of pharmacy who shall: (1) Be in full and actual charge of the pharmacy and its personnel; (2) Be responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title; and (3) Review the policies and procedures of the pharmacy annually and revise them as necessary. B. Staff. (1) The pharmacy permit holder shall employ licensed pharmacists, registered pharmacy technicians, and unlicensed personnel as required to competently and safely provide pharmacy services. (2) The director of pharmacy shall delegate responsibility for the operations of the pharmacy to a designated pharmacist when the director of pharmacy is not available. #### Regulation .06 Security. *COMAR 10.34.03.06* A. If a pharmacist is not present within the pharmacy, the pharmacist shall lock and secure the pharmacy and any of its decentralized areas that contain pharmaceuticals before leaving the pharmacy or the decentralized area. B. The director of pharmacy shall establish policies and procedures for emergency access to the pharmacy or any of its decentralized areas. C. Security Requirements. Entry into an institutional pharmacy area where prescription drugs or devices are held shall be limited to authorized personnel under a pharmacist’s direct supervision. D. An institutional pharmacy shall be equipped with: (1) A security system to detect entry after hours, if applicable; (2) A security system that provides additional protection against theft and diversion; (3) Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records; (4) An inventory management and control system designed to protect against, detect, and document instances of theft, diversion, or counterfeiting; (5) A security system designed to protect the integrity and confidentiality of data and documents; (6) Video monitoring of entrances and exits, or alternate acceptable security; and (7) A means to make the data and documentation required under this chapter readily available to: (a) The Board; (b) An agent of the Board; or (c) Federal and State regulatory and law enforcement officials. #### Regulation .07 Physical Requirements and Equipment. *COMAR 10.34.03.07* A. The institutional pharmacy shall have floor space, shelving, and equipment to ensure that drugs and supplies within the institutional pharmacy are properly stored and prepared with respect to sanitation, temperature, light, ventilation, moisture control, segregation, and security. B. The institutional pharmacy shall have professional and technical equipment, supplies, and adequate physical facilities for proper compounding, dispensing, and storage of drugs. C. The institutional pharmacy shall have reference materials as required by COMAR 10.34.07.03 to enable personnel to prepare and dispense drugs properly and perform pharmaceutical care functions. D. The institutional pharmacy shall store alcohol and flammables in areas that meet basic local building code requirements for the storage of volatiles and such other laws, ordinances, or regulations as may apply. E. An institutional pharmacy that provides parenteral preparations shall comply with COMAR 10.34.19. F. The institutional pharmacy shall dispose of hazardous materials consistent with State and federal laws and regulations; G. The institutional pharmacy is responsible for the maintenance of the institution’s automated medication systems in compliance with COMAR 10.34.28 #### Regulation .08 Responsibilities of Director of Pharmacy. *COMAR 10.34.03.08* The director of pharmacy or designee shall: A. Be responsible for the safe and efficient dispensing, control, security, and accountability of drugs; B. Work in cooperation with the other professional staff of the institutional facility with respect to the duties listed in this regulation and in ordering, administering, and controlling drug products and materials, including prescription blanks; C. Supervise the preparation of parenteral and other medications compounded within the institutional facility; D. Provide written policies and procedures to hospital professional and technical staff with regard to admixtures prepared within the institution outside of the institutional pharmacy including, but not limited to: (1) Establishing policies and procedures for preparation and handling of the admixtures; and (2) Providing incompatibility information with respect to the admixtures; E. Recommend specifications for procurement, storage and disposal of drugs, chemicals, and biologicals administered to patients to the appropriate committee of the institutional facility as determined by the governing body; F. Participate in the development of a formulary for the facility; G. Establish procedures for the development of a standard format and ongoing procedures for checking the accuracy and placement of labels on medications throughout the institution; H. Maintain and make available an inventory of antidotes and other emergency drugs, both in the pharmacy and in patient care areas, as well as: (1) Current antidote information; (2) Telephone numbers of a regional poison information center; (3) Other emergency assistance organizations; and (4) Such other materials and information as may be considered necessary by the governing body of the institutional facility; I. Maintain records of transactions of the institutional pharmacy as may be required by applicable law and as may be necessary to maintain accurate control and accountability for pharmaceuticals; J. Participate in those aspects of the institutional facility's quality assurance and improvement program which relate to medication safety and pharmaceutical utilization and effectiveness; K. Participate in teaching or research programs, or both, in the institutional facility as required; L. Implement the policies, procedures, and decisions of the governing body of the institutional facility; M. Ensure that a system is in place that provides a safe, secure, and efficient distribution system for pharmaceutical products within the facility; N. Ensure that the institutional pharmacy meets inspection and other requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and these regulations; O. Develop and implement policies and procedures to ensure that discontinued and outdated drugs and drug containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition; P. Establish policies and procedures for identification, handling, storage, and disposition of medications brought into the institution by the patients; Q. Conduct an on-going plan for a quality assurance program that will review and evaluate pharmaceutical services and recommend improvements in these services; R. Establish policies and procedures for identification and handling of investigational drugs that include the provision of pharmacologic and toxicologic information to the medical and nursing staff according to institutional policies ; S. Arrange for the inspection of drug storage areas throughout the institution on a monthly basis and maintain written records of these reviews; and T. Participate in developing and monitoring the policies and procedures pertaining to: (1) Administration of drugs at an institutional facility to ensure that only authorized individuals administer drugs; and (2) Self-administration of drugs not on the hospital formulary by patients to ensure that the: (a) Administration occurs in accordance with procedures established by the appropriate committee of the institution; and (b) That the self-administration is ordered by an authorized prescriber. #### Regulation .09 Medication Packaging — Record Keeping. *COMAR 10.34.03.09* A. A licensed pharmacist shall verify the selection of medication to be packaged and verify the completed packaging of medication performed by a registered pharmacy technician for the following: (1) Accuracy; (2) Completeness: (3) Appropriateness; and (4) Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging. B. Packaging from the Manufacturer’s Original Container. The pharmacy shall use a master log with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the: (1) Lot number assigned by the distributor or manufacturer; (2) Manufacturer’s expiration date; (3) Manufacturer; (4) Lot number assigned by the pharmacy; (5) Quantity packaged; (6) Expiration date as defined in §C of this regulations; (7) Generic name of the drug; (8) Strength; (9) Date of packaging; (10) Name of person packaging; and (11) Initials of verifying licensed pharmacist. C. Unless the licensed pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of: (1) Twelve months from the date of packaging; (2) The manufacturer’s or distributor’s listed expiration date; or (3) The maximum time period allowed for the specific packaging used for the medication. D. The licensed pharmacist shall ensure that labeling of the medication container includes the: (1) Generic name of the medication; (2) Brand name of the medication, if appropriate (3) Strength of the medication, if appropriate; (4) Lot number of the distributor or manufacturer; (5) Expiration date of the medication; and (6) Beyond use date of the medication, if appropriate. #### Regulation .10 Labeling for Use Outside the Institutional Facility. *COMAR 10.34.03.10* A. The director of pharmacy or designee shall ensure that the labels on drugs dispensed for use outside the facility by an institutional pharmacy to clinics, ambulatory patients, or other patients about to be discharged meet the requirements of Health Occupations Article, §12-505, Annotated Code of Maryland. B. The director of pharmacy or designee shall ensure that the labels contain other information that may be required by federal or State law or regulations including, but not limited to, cautionary information. #### Regulation .11 Drug Dispensing — Emergency Supplies and Procedures. *COMAR 10.34.03.11* A. The director of pharmacy shall participate in the development and maintenance of the formulary for emergency drugs and supplies that are maintained throughout the institutional facility. B. The director of pharmacy or designee shall, in conjunction with the medical staff of the institutional facility, develop and implement written policies and procedures to ensure compliance with the provisions of this regulation. C. The institutional pharmacy shall furnish emergency drugs and supplies only if: (1) The emergency drugs and supplies are stored in an environment which: (a) Maintains the integrity of the drugs; and (b) Provides accessibility only to authorized personnel; (2) The institution follows a policy that drugs will be dispensed from the emergency drugs and supplies formulary only upon written or verbal order by an authorized prescriber; (3) The emergency drugs and supplies are stocked and maintained in a manner that complies with the standards of applicable State law; (4) The emergency drugs and supplies are: (a) Stored and secured: (i) With a tamper evident seal; or (ii) Via electronic means; and (b) Kept in a secure area; (5) The emergency drugs and supplies are labeled as follows: (a) Clearly indicating that the emergency drugs and supplies are for use in emergencies only; (b) Listing the expiration dates of the emergency drugs and supplies; (c) Listing the name or initials of the pharmacist who checked the emergency drugs and supplies; and (d) Highlighting the expiration date of the medication with the shortest expiration date; (6) When the emergency drugs and supplies are contained within an emergency cart, the pharmacist checking the emergency cart shall ensure that the exterior of the cart is labeled with the: (a) Contents of the emergency cart; and (b) Name or initials of the pharmacist; and (7) The director of pharmacy or designee shall ensure that repackaged drugs contained in emergency drugs and supplies are labeled: (a) In accordance with Regulation .10 of this chapter; and (b) With other information as may be required by the medical staff. D. Upon notification that emergency drugs and supplies have been opened, a pharmacist or registered pharmacy technician shall: (1) Restock the emergency drugs and supplies; or (2) Provide a replacement supply. E. The director of pharmacy or designee shall ensure: (1) That the expiration date of emergency drugs and supplies is the earliest date of expiration of any drug supplied; and (2) Before the expiration date, the pharmacist or designee shall replace the expired drug and relabel the emergency drugs and supplies as provided in §C(5) of this regulation. #### Regulation .12 Drug Dispensing — Prescribers' Orders. *COMAR 10.34.03.12* A. Drugs may be dispensed from the institutional pharmacy only in response to medication orders issued by prescribers who have been authorized to do so by law and by the governing body of the institution. B. Documentation. (1) Institutional Medication Protocols. (a) The pharmacist may dispense, or make available, drugs for an approved institutional medication protocol if conditions designated by the institution are met. (b) The director of pharmacy or designee shall assist in establishing institutional policies and procedures governing the development of order-sets for each individual situation for which institutional medication protocol orders exist. (c) The appropriate committee of the institution shall approve any order-sets before the pharmacist may provide the medications based on the institutional medication protocol. (2) A pharmacist may provide medications based on orders which do not contain unapproved abbreviations as published by the appropriate committee of the institutional facility. (3) The director of pharmacy or designee shall ensure that authorized personnel have access to patient information necessary for drug monitoring including the patient's: (a) Sex; (b) Age; (c) Weight; (d) Height; (e) Diagnosis; (f) Medication and food allergies; (g) Pregnancy and lactation status; (h) Vaccination status; and (i) Name. #### Regulation .13 Controlled Dangerous Substances. *COMAR 10.34.03.13* A. Drug Accountability. (1) The director of pharmacy is responsible for establishing procedures and maintaining adequate written or electronic records regarding dispensing and accountability of controlled dangerous substances which specify at least the following: (a) Name and strength of the drug; (b) Dose; (c) Dosage form; (d) Prescriber; (e) Patient name with second identifier; (f) Date and time of administration; and (g) Individual administering the drug; (2) The director of pharmacy shall be responsible for establishing and maintaining adequate procedures for documentation of: (a) Recording of receipt of delivery to the pharmacy; (b) Entering into pharmacy inventory; (c) Receiving into Schedule II inventory; and (d) Dispensing of controlled dangerous substances, Schedule II — Schedule V. (3) The director of pharmacy or designee shall be responsible for establishing and maintaining adequate procedures for documenting partially administered controlled dangerous substances: (a) For disposal by hospital policy; and (b) Return of unused drugs to the pharmacy. (4) The director of pharmacy or designee shall establish procedures to ensure that controlled dangerous substance records include the handwritten or electronic signature of the individual authorized: (a) By the institution to dispose of drugs or to return them to the pharmacy; and (b) To witness the disposal, as defined by the institution's policies and procedures. B. Storage and Security in the Institutional pharmacy. (1) On at least a monthly basis, a pharmacist or registered pharmacy technician shall perform a physical count of each Schedule II controlled dangerous substance in the pharmacy and shall then compare that count with the perpetual inventory maintained by the pharmacy with reference to each drug; (2) On at least a monthly basis, the director of pharmacy or designee shall: (a) Investigate discrepancies within the pharmacy; (b) Report losses as required by law; and (c) Take appropriate action; and (3) The director of pharmacy or designee shall establish a procedure by which previously dispensed controlled dangerous substances that are no longer necessary for medical reasons are returned to the pharmacy. C. Storage and Security in the Institution. The director of pharmacy shall develop policies that only permit the dispensing of controlled dangerous substances when the following security precautions exist in the institution and the pharmacy: (1) Access to controlled dangerous substances outside the pharmacy is restricted to authorized personnel approved by institutional policy; (2) Controlled dangerous substances stored outside the pharmacy are accounted for at least at the change of each shift by licensed personnel authorized by the institution, unless a controlled access automated dispensing system provides an on-demand report of a perpetual inventory; and (3) A pharmacist reviews the discrepancies in counts of controlled dangerous substances previously reported by other professional personnel. #### Regulation .14 Drug Recalls. *COMAR 10.34.03.14* A. The director of pharmacy or designee shall develop and implement a drug recall procedure that can be readily activated to assure that drugs which have been recalled are returned to the pharmacy for proper disposition. B. If a recall has been initiated for a drug that has been purchased by the institution, the director of pharmacy or designee shall issue a notice in a timely manner informing affected departments of the institution that the drug shall be returned to the pharmacy for proper return or disposal. C. The institutional pharmacy is responsible for the timely retrieval of affected drugs. #### Regulation .15 Adverse Drug Events. *COMAR 10.34.03.15* A. The director of pharmacy or designee shall participate in the appropriate committee or committees to establish procedures to report and record adverse drug events including medication errors and adverse drug reactions. B. The director of pharmacy or designee shall immediately report adverse drug events to the prescriber, or the prescriber's designee, and make a written or electronic report to the appropriate committee or committees, as determined by the governing body of the institutional facility. C. The director of pharmacy shall participate in the deliberations of the institutional committee charged with the development of the programmatic and operational changes that result from the analysis of medication errors or other adverse events. D. The director of pharmacy, in collaboration with the medical staff and other appropriate departments and services, shall develop and maintain a process for training staff regarding detecting and reporting medication errors to prevent future occurrences. E. The director of pharmacy or designee shall make further reports of adverse reactions as required by federal or State law. #### Regulation .16 Pharmaceutical Care Functions of the Pharmacist. *COMAR 10.34.03.16* The pharmacist shall be available as necessary to provide pharmaceutical care to individual patients including, but not limited to: A. Participating in decisions about medication use for patients including decisions not to use medication therapy as well as judgments about: (1) Medication selection; (2) Dosages; (3) Routes and methods of administration; (4) Medication therapy monitoring; and (5) The provision of medication-related information and counseling to individual patients; B. Cooperating directly with health care professionals and the patient in designing, implementing, and monitoring a therapeutic outcome. C. Providing care directly to the patient to improve a patient’s quality of life through achieving definite and predefined, medication-related therapeutic outcomes such as: (1) Curing the disease; (2) Eliminating or reducing a symptomatology; (3) Arresting or slowing a disease process; (4) Preventing a disease or symptomatology; and (5) Improving patient’s quality of life. D. Identifying potential and actual medication-related problems, resolving actual medication-related problems, and preventing potential medication-related problems caused by: (1) Untreated indications; (2) Improper drug selection; (3) Sub-therapeutic dosage; (4) Failure to received medication; (5) Over dosage; (6) Adverse drug reactions; (7) Drug interactions, including drug-drug, drug-food, drug-laboratory test interactions; and (8) Medication use without appropriate indication. #### Regulation .17 Requirements for a Decentralized Pharmacy. *COMAR 10.34.03.17* A. A decentralized pharmacy is subject to: (1) Health Occupations Article, Title 12, Annotated Code of Maryland; (2) This subtitle; and (3) Other applicable State and federal laws and regulations. B. A decentralized pharmacy shall ensure that a licensed pharmacist is immediately available on the premises of the decentralized pharmacy to: (1) Supervise pharmacy operations; and (2) Provide the final check for preparing medication orders for administration in the institutional facility. C. Notwithstanding §B of this regulation, a pharmacist assigned to a decentralized pharmacy may leave the decentralized pharmacy for a short period of time to perform pharmaceutical care functions in the institutional facility. D. A director of pharmacy of the institutional pharmacy shall be responsible for pharmacy operations involving a decentralized pharmacy, including direct supervision of decentralized pharmacy personnel by a pharmacist and compliance with this chapter. E. A pharmacy department may store prescription medications and over the counter medications that are approved for use by the institutional pharmacy as required for the treatment of patients in the nursing unit served by the decentralized pharmacy. F. An institutional pharmacy and the decentralized pharmacy shall have shared common electronic files or appropriate technology to allow access to sufficient information necessary or required to process functions required for the care of patients within the service area of the decentralized pharmacy. G. A decentralized pharmacy shall have a pharmacist physically located at the decentralized pharmacy to directly supervise pharmacy technicians and pharmacy technician trainees during hours of operation. H. An institutional pharmacy shall notify the Board in writing within 14 days of a change of location, discontinuance of service, or closure of a decentralized pharmacy. I. Security. (1) In addition to the security requirements outlined in COMAR 10.34.05, a decentralized pharmacy shall have adequate security and procedures to: (a) Prohibit unauthorized access; (b) Comply with federal and State regulations; and (c) Maintain patient confidentiality. (2) Access to the decentralized pharmacy shall be limited to pharmacists, pharmacy technicians, and pharmacy technician trainees employed by the institutional pharmacy, and other personnel authorized by the director of pharmacy. ### Chapter 04 — Transfer and Outsourcing of Prescriptions and Prescription Orders **Authority:** Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland **Administrative History:** Effective date: May 4, 1979 (6:9 Md. R. 728) **Administrative History:** Regulation .01 amended effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulation .02 amended effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulation .03A amended effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulations .01 — .04, Transfer of Prescriptions Between Pharmacies repealed effective June 25, 2001 (28:12 Md. R. 1110) **Administrative History:** Regulation .01 — .09 Transfer and Outsourcing of Prescriptions and Prescription Orders adopted effective June 25, 2001 (28:12 Md. R. 1110) **Administrative History:** Regulation .01A amended effective September 29, 2025 (Md. R. 956) **Administrative History:** Regulation .03 amended effective September 29, 2025 (Md. R. 956) **Administrative History:** Regulation .06 recodified to Regulation .07 effective September 29, 2025 (Md. R. 956) **Administrative History:** Regulation .06 adopted effective September 29, 2025 (Md. R. 956) **Administrative History:** Regulation .07 recodified to Regulation .08 effective September 29, 2025 (Md. R. 956) **Administrative History:** Regulation .08 recodified to Regulation .09 effective September 29, 2025 (Md. R. 956) **Administrative History:** Regulation .09 recodified to Regulation .10 effective September 29, 2025 (Md. R. 956) #### Regulation .01 Scope. *COMAR 10.34.04.01* This chapter governs the: A. Transfer of prescriptions for non-controlled dangerous substances between pharmacies; B. Filling of prescriptions at one pharmacy pursuant to the request of staff of a second pharmacy; and C. Preparation of medication for stock and investigational use. #### Regulation .02 Definitions. *COMAR 10.34.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Outsourcing” means the transmitting of a prescription order from a primary pharmacy to a secondary pharmacy that prepares the prescription. (2) “Patient specific” means a prescription order prepared and labeled for a specific individual. (3) “Preparation” means compounding or packaging of medication. (4) “Primary pharmacy” means the pharmacy that initially receives a prescription order. (5) “Secondary pharmacy” means the pharmacy to which a prescription order is transmitted for subsequent dispensing to a patient. (6) “Stock medication” means medication that is not labeled for, or intended for, use by a specific patient when it leaves the pharmacy, but is intended to be stored and ultimately administered by a licensed health care professional in accordance with applicable laws and regulations. #### Regulation .03 Permanent Transfer of a Prescription Between Pharmacies. *COMAR 10.34.04.03* A pharmacist from a primary pharmacy may permanently transfer a prescription order to a secondary pharmacy to be dispensed to a specific patient if the pharmacist transferring the prescription from the primary pharmacy indicates on the prescription, within the prescription computer database and within any appropriate other records used for dispensing: A. That the prescription has been permanently transferred; B. The name of the secondary pharmacy; C. The name of the pharmacist who transferred the prescription to the secondary pharmacy; D. The name of the pharmacist at the secondary pharmacy to whom the prescription was transferred if the transfer occurred in an oral manner; and E. The date on which the prescription was transferred to the secondary pharmacy. #### Regulation .04 Refilling of Permanently Transferred Prescriptions. *COMAR 10.34.04.04* A. A pharmacist at the primary pharmacy may not refill a prescription that has been permanently transferred to a secondary pharmacy. B. The use of unified prescription records by more than one pharmacy through a computerized prescription database does not constitute a permanent transfer of a prescription order. #### Regulation .05 Documentation by the Secondary Pharmacy Receiving a Permanent Prescription Transfer. *COMAR 10.34.04.05* The pharmacist at the secondary pharmacy who receives a permanently transferred prescription document is responsible for maintaining documentation in a readily retrievable and identifiable manner which includes: A. That the prescription was transferred from another pharmacy; B. The name and information identifying the specific location of the primary pharmacy; C. The name of the pharmacist who transferred the prescription to the secondary pharmacy; D. The name of the pharmacist at the secondary pharmacy who accepted the transferred prescription; E. The date of issuance of the original prescription order; F. The date on which the prescription order was first filled; G. The date of the last refill; H. The number of remaining refills; I. The original prescription number; and J. The date on which the prescription was transferred to the secondary pharmacy. #### Regulation .06 Transfers of Prescription for Controlled Dangerous Substances. *COMAR 10.34.04.06* A pharmacist may transfer a prescription for a controlled dangerous substance in accordance with federal law. #### Regulation .07 Outsourcing of a Prescription Order. *COMAR 10.34.04.07* A pharmacist from a primary pharmacy may transmit a prescription order to a secondary pharmacy for preparation and final dispensing to a specific patient or for return to the primary pharmacy for final dispensing to a specific patient if: A. The label contains the name, address, and phone number of the primary pharmacy; B. The patient is informed in writing of the name and address of the secondary pharmacy; C. The patient is informed in writing that the prescription order was prepared at a secondary pharmacy; D. The original prescription order is filed as a prescription order at the primary pharmacy; E. The pharmacist from the primary pharmacy documents in a readily retrievable and identifiable manner: (1) That the prescription order was prepared by a secondary pharmacy; (2) The name of the secondary pharmacy; (3) The name of the pharmacist who transmitted the prescription order to the secondary pharmacy; (4) The name of the pharmacist at the secondary pharmacy to whom the prescription order was transmitted if the transmission occurred in an oral manner; (5) The date on which the prescription was transmitted to the secondary pharmacy; and (6) The date on which the medication was sent to the primary pharmacy; F. Both the primary and secondary pharmacies are licensed in this State, or operated by the federal government; and G. The primary pharmacy maintains, in a readily retrievable and identifiable manner, a record of preparations received from the secondary pharmacy. #### Regulation .08 Documentation by the Secondary Pharmacy when a Prescription Order is Outsourced. *COMAR 10.34.04.08* The permit holder at the secondary pharmacy is responsible for maintaining documentation in a readily retrievable and identifiable manner, which includes: A. That the prescription order was transmitted from another pharmacy; B. The name and information identifying the specific location of the primary pharmacy; C. The name of the pharmacist who transmitted the prescription to the secondary pharmacy if the transmission occurred in an oral manner; D. The name of the pharmacist at the secondary pharmacy who accepted the transmitted prescription order; E. The name of the pharmacist at the secondary pharmacy who prepared the prescription order; F. The date on which the prescription order was received at the secondary pharmacy; and G. The date on which the prepared product was sent to the primary pharmacy if it was sent back to the primary pharmacy. #### Regulation .09 Preparation of Stock and Investigational Medications. *COMAR 10.34.04.09* A. A pharmacist may provide medication for use as stock medication for a licensed health care facility in accordance with applicable laws, if the pharmacy providing the medication also serves as the primary provider of patient specific medication for the facility. B. A pharmacist may provide medication for use as stock medication for final dispensing or administration by an authorized prescriber who is permitted by law to administer or dispense medication if the pharmacist receives a written stock medication order from the authorized prescriber for each delivery of medication to the authorized prescriber. C. A pharmacist may prepare, package, and label investigational drugs not destined for a specific individual at the time of preparation, packaging, and labeling if: (1) The study for which medications are prepared, packaged, and labeled is approved by an institutional review board as defined in federal law; and (2) The pharmacy permit holder ensures that records disclosing the identity of the subject who eventually receives the medication are: (a) Received by a pharmacist on duty at the pharmacy within 30 days after being provided to a patient; and (b) Maintained in the pharmacy. #### Regulation .10 Permit and Quality Assurance. *COMAR 10.34.04.10* A. The permit holder of a pharmacy which prepares patient specific prescriptions as a secondary pharmacy such that these prescriptions account for 5 percent or more of the pharmacy's total number of prescriptions filled shall submit to the Board of Pharmacy, for approval by the Board or a designee of the Board, a plan detailing the steps it has taken to ensure the safety and quality of prescriptions filled as a secondary pharmacy. B. The plan under §A of this regulation shall include: (1) Measures to be taken to comply with State and federal laws; (2) The method by which each pharmacist responsible for each prescription is identified in the records; (3) Measures taken to maintain the security, integrity, and confidentiality of patient records; and (4) The establishment and maintenance of a quality assurance program. C. Except as provided in Regulation .06 of this chapter, a permit holder of a pharmacy shall obtain manufacturing and distribution permits in order to compound or package medication that is not prepared as a prescription destined for a specific patient, but is forwarded to another pharmacy, authorized prescriber, licensed distributor, or other person or entity. ### Chapter 05 — Pharmacy Security **Authority:** Health Occupations Article, §12-205, Annotated Code of Maryland **Administrative History:** Effective date: July 25, 1980 (7:15 Md. R. 1425) **Administrative History:** Regulation .02C adopted effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Chapter, Security of a Pharmacy Facility, repealed and new chapter, Pharmacy Security, adopted effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Regulation .02C adopted effective July 1, 2010 (37:10 Md. R. 722) **Administrative History:** Regulation .05 amended effective July 1, 2010 (37:10 Md. R. 722); May 20, 2019 (46:10 Md. R. 489) #### Regulation .01 Definitions. *COMAR 10.34.05.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Emergency” means an event such as a fire, water leak, electrical failure, public disaster, or catastrophe which may impact the prescription area. (2) “Means of access” means the manner of entry into the secure prescription area. (3) “Prescription area” means the portion of an establishment for which a pharmacy permit has been issued which contains: (a) Patient records; (b) Prescription devices; and (c) Prescription drugs. #### Regulation .02 Prescription Area. *COMAR 10.34.05.02* A. The pharmacy permit holder shall: (1) Ensure that the prescription area: (a) Maintains temperature and ventilation at levels that do not affect the prescription drugs or devices stored in the area; and (b) Permits reasonable communication between the pharmacist and the public when the pharmacy is open; (2) Provide a means of securing the prescription area; (3) Prevent an individual from being in the prescription area unless a pharmacist is immediately available on the premises to provide pharmacy services; (4) Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and (5) Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open. B. The pharmacist shall: (1) Secure the prescription area and its contents in order that the pharmacy permit holder or the pharmacy permit holder's agent may: (a) Monitor unauthorized or emergency entry after the prescription area has been secured by the pharmacist; and (b) Prevent unauthorized entry when the prescription area is closed during a period that the rest of the establishment is open; (2) Have sole possession of a means of access to the pharmacy, except in emergencies; and (3) Establish a means of access for use in an emergency when the pharmacist is not available to access the prescription area. C. Security. (1) A pharmacy shall be secure from unauthorized entry as follows: (a) Access from outside the premises shall be: (i) Kept to a minimum; and (ii) Well controlled; (b) The outside perimeter of the premises shall be well lit; and (c) Entry into areas where prescription drugs or devices and patient records are stored shall be limited to authorized personnel. (2) A pharmacy shall be equipped with: (a) An alarm system to detect entry after hours; (b) A security system that provides protection against theft and diversion; (c) Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records; (d) An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; (e) A security system to protect the integrity and confidentiality of data and documents limited to authorized personnel; and (f) A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, the Division of Drug Control, or federal and other State law enforcement officials. #### Regulation .03 Pharmacy Operation. *COMAR 10.34.05.03* A. A pharmacist shall be immediately available on the premises to provide pharmacy services at all times the pharmacy is in operation. B. If the prescription area is not open the same hours as the establishment, the pharmacy permit holder shall prominently display signs indicating the business hours of the prescription area. #### Regulation .04 Records. *COMAR 10.34.05.04* A. A pharmacy permit holder shall: (1) Prevent unauthorized disclosure or loss by securing all patient records; (2) Designate personnel with authorized access to computerized patient records; and (3) Maintain current computerized records in a manner which permits reconstruction within 48 hours, except: (a) In an emergency as defined in Regulation .01 of this chapter, or (b) With the prior approval of the Board. B. A pharmacy permit holder may store patient records away from the prescription area in a manner that prevents unauthorized disclosure or loss. #### Regulation .05 Security Responsibility. *COMAR 10.34.05.05* A. The pharmacy permit holder is responsible for ensuring that pharmacists, employees, and others who enter the pharmacy: (1) Know and abide by the requirements of this chapter; (2) Maintain those measures necessary to ensure this chapter’s enforcement; (3) Report theft or significant loss of controlled dangerous substances to the: (a) Board; (b) Local police; (c) Office of Controlled Substances Administration; and (d) U.S. Drug Enforcement Administration; and (4) Report theft of non-controlled prescription drugs or devices to the Board. B. In determining whether a loss is significant pursuant to §A(3) of this regulation, the pharmacy permit holder shall consider at least the following factors: (1) The actual quantity of controlled dangerous substances lost in relation to the type of business; (2) The specific controlled dangerous substances lost; (3) Whether the loss of the controlled dangerous substances can be associated with access to those controlled dangerous substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving controlled dangerous substances; (4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; (5) Whether the specific controlled dangerous substances are likely candidates for diversion, if known; and (6) Local trends and other indicators of the diversion potential of the missing controlled dangerous substances, if known. ### Chapter 06 — Reporting Pharmacist's, Pharmacy Intern's, and Pharmacy Technician's Mailing Address and Location of Employment **Authority:** Health Occupations Article, §12-205, Annotated Code of Maryland **Administrative History:** Effective date: July 25, 1980 (7:15 Md. R. 1425) **Administrative History:** Chapter, Posting of Prescription Prices and Services, repealed effective April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulations .01 — .05, Reporting Pharmacist's Mailing Address and Location of Employment, adopted effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulations .01 — .05, Reporting Pharmacist's and Pharmacy Technician's Mailing Address and Location of Employment amended effective March 18, 2013 (40:5 Md. R. 411) **Administrative History:** Regulations .01, .03, .04, and .05, Reporting Pharmacist's, Pharmacy Intern's, and Pharmacy Technician's Mailing Address and Location of Employment amended effective July 1, 2015 (42:7 Md. R. 569) #### Regulation .01 Scope. *COMAR 10.34.06.01* This chapter applies to each pharmacist, pharmacy intern, and pharmacy technician licensed or registered by the Maryland Board of Pharmacy. #### Regulation .02 Definitions. *COMAR 10.34.06.02* A. In these regulations, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Mailing address” means the address the pharmacist or pharmacy technician specifies that the Board use when communicating with the pharmacist or pharmacy technician. (3) “Primary employment location” means the establishment where the pharmacist or pharmacy technician is employed on a regular basis or works most often. #### Regulation .03 Mailing Address. *COMAR 10.34.06.03* A. Each licensed pharmacist, pharmacy intern, and registered pharmacy technician shall report to the Board the pharmacist’s, pharmacy intern’s, or pharmacy technician’s current mailing address on the pharmacist’s, pharmacy intern’s, or pharmacy technician’s biennial license or registration renewal form. B. The mailing address: (1) May be the pharmacist’s residence address; (2) Shall be the pharmacy intern’s residence address; or (3) Shall be the pharmacy technician’s residence address. C. Within 30 days of the date a pharmacist, pharmacy intern, or pharmacy technician changes the pharmacist’s, pharmacy intern’s, or pharmacy technician’s mailing address, the pharmacist, pharmacy intern, or pharmacy technician shall notify the Board in writing of any change in the information in §A of this regulation. #### Regulation .04 Place of Employment. *COMAR 10.34.06.04* A. This regulation applies only to pharmacists, pharmacy interns, and pharmacy technicians employed in Maryland. B. Each licensed pharmacist, registered pharmacy intern, and registered pharmacy technician shall report to the Board the pharmacist’s, pharmacy intern’s, or pharmacy technician’s place of employment on the pharmacist, pharmacy intern, or pharmacy technician biennial license or registration renewal form. A pharmacist, pharmacy intern, or pharmacy technician employed at more than one location shall report the primary employment location at the time the renewal form is submitted to the Board. C. Within 30 days of a change in the pharmacist’s, pharmacy intern’s, or pharmacy technician’s primary employment location, the pharmacist, pharmacy intern, or pharmacy technician shall notify the Board in writing of any change in the information required by this regulation. If the pharmacist’s, pharmacy intern’s, or pharmacy technician’s primary employment location changes and the pharmacist’s, pharmacy intern’s, or pharmacy technician’s new primary employment location is owned by the same corporation, partnership, or individual owner, the pharmacist, pharmacy intern, or pharmacy technician is not required to report the change except when completing a biennial license or registration renewal form. #### Regulation .05 Grounds for Disciplinary Action. *COMAR 10.34.06.05* A. A pharmacist’s failure to report the information required in Regulations .03 and .04 of this chapter or failure to provide the Board with complete, up-to-date, and accurate information shall constitute grounds for action under Health Occupations Article, §12-313(b)(25), Annotated Code of Maryland, and may, in appropriate cases, constitute grounds for action under Health Occupations Article, §12-313(b)(1), (7), or (8), Annotated Code of Maryland. B. A pharmacy technician’s failure to report the information required in Regulations .03 and .04 of this chapter or failure to provide the Board with complete, up-to-date, and accurate information shall constitute grounds for action under Health Occupations Article, §12-6B-09(25), Annotated Code of Maryland, and may, in appropriate cases, constitute grounds for action under Health Occupations Article, §12-6B-09(2), (7), or (8), Annotated Code of Maryland. C. A pharmacy intern’s failure to report the information required in Regulations .03 and .04 of this chapter or failure to provide the Board with complete, up-to-date, and accurate information: (1) Shall constitute grounds for action under Health Occupations Article, §12-6D-11(18), Annotated Code of Maryland; and (2) May, in appropriate cases, constitute grounds for action under Health Occupations Article, §12-6D-11(3), (7), or (8), Annotated Code of Maryland. ### Chapter 07 — Pharmacy Equipment **Authority:** Health Occupations Article, §§12-205 and 12-403, Annotated Code of Maryland **Administrative History:** Effective date: March 21, 1980 (7:6 Md. R. 608) **Administrative History:** Regulation .03 adopted effective September 10, 1984 (11:18 Md. R. 1585) **Administrative History:** Chapter revised effective February 19, 1990 (17:3 Md. R. 298) **Administrative History:** Regulation .03 amended effective November 7, 1994 (21:22 Md. R. 1877) **Administrative History:** Regulation .01A amended effective August 30, 2004 (31:17 Md. R. 1312) **Administrative History:** Chapter revised effective July 1, 2010 (37:10 Md. R. 722) **Administrative History:** Regulation .01-1 amended effective September 29, 2025 (52:19 Md. R. 956) #### Regulation .01 Definitions. *COMAR 10.34.07.01* A. In this chapter, the following term has the meaning indicated. B. Term Defined. “Material safety data sheets” means a list of hazardous chemicals that provides detailed information on each hazardous chemical, including its potential hazardous effects, its physical and chemical characteristics and recommendations for appropriate protective measures. #### Regulation .01-1 Equipment. *COMAR 10.34.07.01-1* A pharmacy shall have the following equipment to carry out the practice of pharmacy in Maryland: A. If applicable, a Class A prescription balance and weights, or a prescription balance with equivalent or superior sensitivity to a Class A prescription balance; and B. A refrigerator and freezer, if applicable, solely for the storage of drugs requiring refrigeration, with a thermometer or a temperature monitoring device. #### Regulation .02 Additional Equipment. *COMAR 10.34.07.02* The pharmacy shall maintain additional equipment to enable it to prepare and dispense prescriptions properly consistent with its scope of practice. #### Regulation .03 Reference Libraries. *COMAR 10.34.07.03* A. A pharmacy permit holder shall maintain an adequate reference library to enable it to prepare and dispense prescriptions properly, consistent with its scope of practice. B. A pharmacy permit holder shall maintain a library of reference sources appropriate to the type of pharmacy practice at that particular location. A pharmacy permit holder shall include in the pharmacy's library current material regarding the technical, clinical, and professional aspects of practice with emphasis in the area in which the pharmacy specializes. B-1. A pharmacy permit holder may utilize websites and electronic references created by established medical publishers which are recognized as standard for a particular type of pharmacy practice as a supplement to its printed library. C. A pharmacy permit holder shall maintain a library containing reference sources that: (1) Enable the pharmacist to compound medications in a safe and effective manner; (2) List the possible drug interactions and possible adverse effects of medications dispensed by the pharmacy; (3) List the therapeutic usage and dosages of medications dispensed by the pharmacy; (4) List the therapeutic equivalents for medications; and (5) Provide guidelines for the counseling of patients. D. A pharmacy permit holder that specializes in nuclear or parenteral prescriptions may limit the library it maintains pursuant to §B of this regulation to the pharmacy permit holder's area of specialization. E. A pharmacy permit holder shall maintain material safety data sheets, if applicable. ### Chapter 08 — Information Required on Prescriptions or Patient Drug Profiles **Authority:** Health Occupations Article, §12-205, Annotated Code of Maryland **Administrative History:** Effective date: February 6, 1981 (8:3 Md. R. 227) **Administrative History:** Chapter revised effective March 15, 1982 (9.5 Md. R. 527) **Administrative History:** Regulation .01B amended effective January 28, 2008 (35:2 Md. R. 127) #### Regulation .01 Information Required on All Original and Refill Prescriptions or Patient Drug Profiles or Computerized Patient Drug Records. *COMAR 10.34.08.01* In addition to the information required by law on every prescription, patient drug profile, or computerized patient drug record, the following information shall be legibly entered on all original and refill prescriptions or patient drug profiles or computerized patient drug records: A. The date of filling or refilling; B. The initials of, or other identifying symbol for: (1) The pharmacist responsible for filling or refilling the prescription; and (2) The data-entry pharmacy technician involved in the dispensing process. #### Regulation .02 Access to Records. *COMAR 10.34.08.02* The information required in Regulation .01 of this chapter shall be readily retrievable for inspection during business hours by authorized personnel. ### Chapter 09 — Fees **Authority:** Health Occupations Article, §§12-205, 12-206, 12-302, 12-303, 12-305, 12-308, 12-310, 12-404, 12-407, 12-601,12-6B-02, 12-6B-03, 12-6B-04, 12-6B-07, 12-6C-03, 12-6C-04, 12-6C-05, 12-6C-06, 12-6D-05, 12-6D-06, and 12-6D-09, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 1981 (8:8 Md. R. 721) **Administrative History:** Regulation .03 amended effective February 19, 1990 (17:3 Md. R. 299) **Administrative History:** Regulations .01—.03 repealed and new Regulations .01—.03 adopted as an emergency provision effective July 1, 1992 (19:12 Md. R. 1131); adopted permanently effective October 1, 1992 (19:15 Md. R. 1391) **Administrative History:** Regulation .01 amended effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .02 amended as an emergency provision effective October 8, 1998 (25:22 Md. R. 1650); amended permanently effective January 14, 1999 (26:1 Md. R. 24) **Administrative History:** Regulation .02 amended effective November 1, 1999 (26:22 Md. R. 1693) **Administrative History:** Regulation .02A amended as an emergency provision effective June 6, 1997 (24:13 Md. R. 928); amended permanently effective September 22, 1997 (24:19 Md. R. 1340) **Administrative History:** Regulation .02C amended effective July 4, 1994 (21:13 Md. R. 1158) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted as an emergency provision effective February 1, 2002 (29:3 Md. R. 213); adopted permanently effective June 10, 2002 (29:11 Md. R. 889) **Administrative History:** Regulation .02 amended effective October 14, 2002 (29:20 Md. R. 1589); January 28, 2008 (35:2 Md. R. 127); February 1, 2010 (36:26 Md. R. 1995); December 21, 2015 (42:25 Md. R. 1543) **Administrative History:** Regulation .02B amended as an emergency provision effective October 1, 2002 (29:25 Md. R. 1979); amended permanently effective March 3, 2003 (30:4 Md. R. 316) **Administrative History:** Regulation .02D amended effective May 20, 2019 (46:10 Md. R. 489) **Administrative History:** Regulation .02K, L amended effective November 10, 2003 (30:22 Md. R. 1582) **Administrative History:** Regulations .03 amended as an emergency provision effective June 28, 1996 (23:15 Md. R. 1083); amended permanently effective October 7, 1996 (23:20 Md. R. 1424) **Administrative History:** Regulation .03 amended as an emergency provision effective October 8, 1998 (25:22 Md. R. 1650); amended permanently effective January 14, 1999 (26:1 Md. R. 24) **Administrative History:** Regulation .03 amended effective November 1, 1999 (26:22 Md. R. 1693); July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .04 adopted effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .04 repealed effective December 21, 2015 (42:25 Md. R. 1543) #### Regulation .01 Scope. *COMAR 10.34.09.01* This chapter governs all licensees, permit holders, registrants, or applicants for licenses or permits issued by the Board. #### Regulation .02 Fees. *COMAR 10.34.09.02* The following fees are established by the Board: A. Pharmacist Fees. (1) Pharmacist examination fee — $150; (2) Pharmacist reciprocity fee — $300; (3) Pharmacist renewal fee — $225; (4) Pharmacist reinstatement fee for up to 2 years after license expiration, payable in addition to renewal fee — $300; and (5) Pharmacist reinstatement fee for more than 2 years after license expiration, payable in addition to renewal fee — $315. B. Pharmacy Fees. (1) Pharmacy initial fee — $700; (2) Pharmacy renewal fee — $500; and (3) Pharmacy — late fee (payable if renewal fee is received between May 2 and June 30) — $200; and (4) Pharmacy reinstatement fee (payable if renewal fee is received after June 30) — $550. C. Distributor Fees. (1) Distributor initial fee — 1,750; (2) Distributor renewal fee — $1,750; and (3) Distributor reinstatement fee after May 31 — $1,500. D. Pharmacy Technician Fees. (1) Pharmacy technician registration fee — $45; (2) Pharmacy technician renewal fee — $45; (3) Pharmacy technician reinstatement fee — $45; (4) Review of pharmacy technician training programs submitted to the Board for approval — $100; and (5) Review of pharmacy technician training programs submitted to the Board for approval that include a didactic portion that is comprised entirely of a didactic program that has already been approved by the Board — no charge. D-1. Pharmacy Intern Fees. (1) Pharmacy intern registration fee — $45; and (2) Pharmacy intern renewal fee — $45. E. Miscellaneous Fees. (1) Duplicate registration fee — $10; (2) Duplicate pharmacist license fee — $30; (2-1) Duplicate pharmacy permit fee — $10; (2-2) Duplicate wholesale distributor permit fee — $30; (3) Written verification of good standing fee — $25; (4) Returned check fee — $35; (5) Roster printed on labels fee — $150; and (6) Failure to maintain current address fee — $25. #### Regulation .03 Change of Fees. *COMAR 10.34.09.03* Fees are subject to change by action of the Board of Pharmacy. Licensees, registrants, and applicants shall be notified of the change. ### Chapter 10 — Pharmacist, Pharmacy Intern, and Pharmacy Technician Code of Conduct **Authority:** Health Occupations Article, §§1-212, 12-205, and 12-601, Annotated Code of Maryland **Administrative History:** Effective date: August 3, 1981 (8:15 Md. R. 1307) **Administrative History:** Regulation .01 amended effective February 19, 1990 (17:3 Md. R. 299) **Administrative History:** Chapter, Standards of Pharmacy Practice, repealed and new chapter, Pharmacist Code of Conduct, adopted effective July 12, 1999 (26:14 Md. R. 1082) **Administrative History:** Regulation .01 amended effective November 12, 2001 (28:22 Md. R. 1937) **Administrative History:** Regulation .02 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .03 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .04 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .06A, B amended effective January 28, 2008 (35:2 Md. R. 127); July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .07A, C amended effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .07C adopted effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .09 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .10 adopted effective February 1, 2016 (43:2 Md. R. 127) #### Regulation .01 Patient Safety and Welfare. *COMAR 10.34.10.01* A. A pharmacist shall: (1) Abide by all federal and State laws relating to the practice of pharmacy and the dispensing, distribution, storage, and labeling of drugs and devices, including but not limited to: (a) United States Code, Title 21, (b) Health-General Article, Titles 21 and 22, Annotated Code of Maryland, (c) Health Occupations Article, Title 12, Annotated Code of Maryland, (d) Criminal Law Article, Title 5, Annotated Code of Maryland, and (e) COMAR 10.19.03; (2) Verify the accuracy of the prescription before dispensing the drug or device if the pharmacist has reason to believe that the prescription contains an error; and (3) Maintain proper sanitation, hygiene, biohazard precautions, and infection control when performing tasks in the prescription process. B. A pharmacist may not: (1) Engage in conduct which departs from the standard of care ordinarily exercised by a pharmacist; (2) Practice pharmacy under circumstances or conditions which prevent the proper exercise of professional judgment; or (3) Engage in unprofessional conduct. C. Therapeutic Interchange. (1) A pharmacist may not perform a therapeutic interchange without the prior approval of the authorized prescriber except as provided in §C(2) of this regulation. (2) A pharmacist who provides a pharmacy service to a patient of a hospital, as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a resident of a comprehensive care or extended care facility, as defined in COMAR 10.07.02.01B, may perform a therapeutic interchange without the prior approval of the authorized prescriber if the governing body of the hospital, comprehensive care facility, or extended care facility has established procedures for therapeutic interchange. (3) This section does not permit any act not otherwise authorized by Health Occupations Article, Title 12, Annotated Code of Maryland. #### Regulation .02 Compensation. *COMAR 10.34.10.02* A pharmacy technician, pharmacy intern, or a pharmacist may not fraudulently seek or accept compensation for a pharmacy product or service not provided. #### Regulation .03 Patient Privacy. *COMAR 10.34.10.03* A. The pharmacy technician, pharmacy intern, pharmacist, and pharmacy permit holder shall ensure confidentiality in creating, storing, accessing, transferring, and disposing of a patient record. B. A pharmacy technician, pharmacy intern, or pharmacist may not disclose identifiable information contained in a patient’s medical record: (1) Without the patient's consent; (2) Without order or direction of a court; or (3) Unless the disclosure is authorized pursuant to Health-General Article, §§4-301 — 4-307, Annotated Code of Maryland. #### Regulation .04 Competence. *COMAR 10.34.10.04* A pharmacy technician, pharmacy intern, or a pharmacist shall: A. Maintain knowledge of the current pharmacy and drug laws and health and sanitation laws relevant to the practice of pharmacy; and B. Provide a pharmaceutical service only within the scope of the pharmacy technician’s, pharmacy intern’s, or pharmacist’s training and education. #### Regulation .05 Duty to Report. *COMAR 10.34.10.05* A. Except when the conduct in question includes drug or alcohol abuse or dependency, a pharmacy technician, pharmacy intern, or pharmacist shall report to the Board: (1) Conduct which violates a statute or regulation pertaining to the practice of pharmacy; (2) Conduct by a pharmacy technician, pharmacy intern, or pharmacist that deceives, defrauds, or harms the public; and (3) The unauthorized practice of pharmacy. B. A pharmacy technician, pharmacy intern, or pharmacist shall report to the pharmacist rehabilitation committee, as defined in Health Occupations Article, §12-317, Annotated Code of Maryland, conduct by a pharmacist technician, pharmacy intern, or pharmacist that involves drug or alcohol abuse or dependency. #### Regulation .06 Discrimination, Harassment, and Sexual Misconduct. *COMAR 10.34.10.06* A. In the practice of pharmacy, a pharmacy technician, pharmacy intern, or pharmacist may not: (1) Discriminate based on age, gender, race, ethnicity, national origin, religion, sexual orientation, disability, socioeconomic status, or other basis as proscribed by law; or (2) Sexually harass a patient, coworker, employee, or supervisee, which includes but is not limited to an unwanted, deliberate, or repeated comment, gesture, or physical contact of a sexual nature. B. Sexual Misconduct. A pharmacy technician, pharmacy intern, or pharmacist may not: (1) Dispense or offer to dispense a prescription drug or device in exchange for: (a) A sexual act such as anal intercourse, analingus, cunnilingus, fellatio, or vaginal intercourse as specified in Criminal Law Article, §3-301(e) and (g), Annotated Code of Maryland, or (b) Sexual contact such as the intentional touching of an intimate part of an individual's body, whether clothed or unclothed, for the purpose of sexual arousal, gratification, abuse of either party, or penetration as specified in Criminal Law Article, §3-301(f), Annotated Code of Maryland; or (2) Engage in sexual behavior including but not limited to a sexual act or sexual contact as specified in §B(1)(a) of this regulation, with a client or patient: (a) In the context of a professional evaluation, treatment, procedure, or other service to the client or patient, regardless of the setting in which the professional service is provided, or (b) Under the pretense of diagnostic or therapeutic intent or benefit. C. Sexual contact does not include an act commonly expressive of familial or friendly affection. #### Regulation .07 Disposition and Return of a Prescription Drug or Device. *COMAR 10.34.10.07* A. A pharmacist may accept the return of a properly labeled and properly sealed manufacturer’s package or individual unit dose of a drug or device that the pharmacist determines to have been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy. B. A pharmacist may not: (1) Return to the pharmacy's stock or offer for sale a prescribed drug or device that has been previously sold and has left the pharmacy's possession except as provided in §A of this regulation; or (2) Sell, give away, or otherwise dispose of a drug, drug accessory, chemical, or device if the pharmacist knows or should know that the drug, drug accessory, chemical, or device is to be used in an illegal activity. C. A pharmacy technician or pharmacy intern may not accept the return of prescription drugs or devices from a patient. #### Regulation .08 Refusing to Dispense a Controlled Substance. *COMAR 10.34.10.08* A. If, based on generally accepted professional standards for the practice of pharmacy, a pharmacist has reason to believe, or should have reason to believe, that a prescription for a controlled dangerous substance was not issued for a legitimate medical purpose in the usual course of the prescriber's practice, the pharmacist may not dispense the controlled dangerous substance until the pharmacist: (1) Consults with the prescriber; and (2) Verifies the medical legitimacy of the prescription. B. If, after consulting with the prescriber, and based on generally accepted professional standards for the practice of pharmacy, a pharmacist has reason to believe that the prescription for a controlled dangerous substance was not issued for a legitimate medical purpose in the usual course of the prescriber's practice, the pharmacist shall: (1) Refuse to dispense the drug; and (2) Report the incident to the regulatory board that licenses the prescriber. #### Regulation .09 Sanctions. *COMAR 10.34.10.09* A. The Board may take action to reprimand a licensee, place the licensee on probation, or suspend or revoke the licensee's license if the licensee commits a violation of this chapter. B. The Board may take action to reprimand a registrant, place the registrant on probation, or suspend or revoke the registrant's registration if the registrant commits a violation of this chapter. C. The Board may impose a monetary penalty as authorized under Health Occupations Article, §§12-314, 12-410, and 12-6B-10, Annotated Code of Maryland. #### Regulation .10 Whole or Substantial Ownership of a Pharmacy by an Authorized Prescriber. *COMAR 10.34.10.10* A. In this regulation, “owned wholly or substantially” means ownership of 10 percent or more of a pharmacy. B. A pharmacist may not associate as a partner, coowner, or employee of a pharmacy that is owned wholly or substantially by an authorized prescriber or group of authorized prescribers. ### Chapter 11 — Disciplinary Sanctions, Monetary Penalties, and Civil Fines **Authority:** Health Occupations Article, §§1-606, 12-313, 12-314, 12-409, 12-410, 12-601, 12-6B-09, 12-6B-10, 12-6C-11, 12-6D-11, 12-6D-12, and 12-707, Annotated Code of Maryland **Administrative History:** Effective date: June 4, 1984 (11:11 Md. R. 962) **Administrative History:** Regulation .01 amended effective January 20, 2003 (30:1 Md. R. 25); January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .02 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .03 amended effective February 19, 1990 (17:3 Md. R. 299); January 20, 2003 (30:1 Md. R. 25) **Administrative History:** Regulation .03A amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .04 amended effective January 20, 2003 (30:1 Md. R. 25) **Administrative History:** Regulation .04-1 adopted effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .05 amended effective January 20, 2003 (30:1 Md. R. 25) **Administrative History:** Regulation .06 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .06C, D amended and .06E, F adopted effective January 20, 2003 (30:1 Md. R. 25) **Administrative History:** Regulation .07B amended effective February 19, 1990 (17:3 Md. R. 299) **Administrative History:** Regulation .07B, D amended effective January 20, 2003 (30:1 Md. R. 25) **Administrative History:** Regulation .07C amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulations .01—.07 repealed and new Regulations .01—.11 adopted effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .02B amended effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .03A amended effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .04A amended effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .04-1 adopted effective July 1, 2015 (42:7 Md. R. 569) **Administrative History:** Regulation .09B, D amended effective July 1, 2015 (42:7 Md. R. 569) #### Regulation .01 Scope. *COMAR 10.34.11.01* This chapter establishes standards for the imposition of disciplinary sanctions, monetary penalties, and civil fines for violations of Health Occupations Article, Title 12, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.34.11.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Act” means Health Occupations Article, Title 12, Annotated Code of Maryland. (2) “Board” means the State Board of Pharmacy. (3) “Civil fine” means a fine assessed by the Board against a person for practicing without an active license, pharmacy permit, registration, or wholesale distributor permit. (4) “License” means, unless the context requires otherwise, a license issued by the Board to practice pharmacy. (5) “Penalty” means monetary penalty. (6) “Pharmacy permit” means a permit issued by the Board to establish and operate a pharmacy. (7) “Registration” means, unless the context requires otherwise, a registration issued by the Board to practice pharmacy as a registered pharmacy intern under the direct supervision of a licensed pharmacist or perform delegated pharmacy acts as a registered pharmacy technician under the direct supervision of a licensed pharmacist. (8) “Sanction” means a disciplinary action reprimanding, restricting, suspending, or revoking a license, pharmacy permit, registration, or wholesale distributor permit. (9) “Wholesale distributor permit” means a permit issued by the Board to establish and operate a wholesale distributor as defined in the Health Occupations Article, §12-6C-01(v), Annotated Code of Maryland. #### Regulation .03 Imposition of Disciplinary Sanctions or Monetary Penalties Generally. *COMAR 10.34.11.03* A. After a hearing pursuant to Health Occupations Article, §12-315, 12-601, 12-6B-09, or 12-6D-11, Annotated Code of Maryland, the Board may impose a penalty against a pharmacy technician, pharmacy intern, pharmacist, or wholesale distributor permit holder pursuant to Health Occupations Article, §12-314, 12-6B-10, 12-6C-11, or 12-6D-12, Annotated Code of Maryland, instead of or in addition to: (1) Reprimanding the registrant, licensee, or wholesale distributor permit holder; (2) Placing the registrant, licensee, or wholesale distributor permit holder on probation; (3) Suspending a registration, license, or wholesale distributor permit; or (4) Revoking a registration, license, or wholesale distributor permit. B. After a hearing pursuant to Health Occupations Article, §12-411, Annotated Code of Maryland, the Board may impose a penalty against a pharmacy permit holder pursuant to Health Occupations Article, §12-410, Annotated Code of Maryland: (1) Instead of or in addition to suspending the pharmacy permit; or (2) In addition to revoking the pharmacy permit. C. Notwithstanding the guidelines set forth in this chapter, in order to resolve a pending disciplinary action, the Board and the registrant, licensee, pharmacy permit holder, or wholesale distributor permit holder may agree to a surrender of a registration, license, pharmacy permit, or wholesale distributor permit or a consent order with terms, sanction, and penalty agreed to by the Board and the registrant, licensee, pharmacy permit holder, or wholesale distributor permit holder. D. Nothing in this chapter prohibits the Board from staying any period of nonactive suspension. #### Regulation .04-1 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Interns. *COMAR 10.34.11.04-1* A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: B. If a registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. C. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. #### Regulation .04 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacists. *COMAR 10.34.11.04* A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: B. If a licensee is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. C. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. D. The Board may not consider a petition for reinstatement of a license that has been revoked until at least 5 years have passed from the date of revocation. #### Regulation .05 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Technicians. *COMAR 10.34.11.05* A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: B. If a registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. C. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. D. The Board may not consider a petition for reinstatement of a registration that has been revoked until at least 5 years have passed from the date of revocation. #### Regulation .06 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Pharmacy Permit Holder. *COMAR 10.34.11.06* A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: B. If a pharmacy permit holder is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. C. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. D. The Board may not consider a petition for reinstatement of a pharmacy permit that has been revoked until at least 5 years have passed from the date of revocation. #### Regulation .07 Guidelines for Imposition of Disciplinary Sanctions or Monetary Penalties on Wholesale Distributor Permit Holder. *COMAR 10.34.11.07* A. Subject to the provisions of this chapter, the Board may impose the following sanctions and, if appropriate, penalties for violations of the Act and its regulations according to the minimum and maximum sanctions and penalties set forth in the following categories: B. If a wholesale distributor permit holder is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. C. A departure from the guidelines set forth in this regulation, on its own, is not grounds for any hearing or appeal of a Board action. D. The Board may not consider a petition for reinstatement of a wholesale distributor permit that has been revoked until at least 5 years have passed from the date of revocation. #### Regulation .08 Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction and Penalty. *COMAR 10.34.11.08* A. Depending upon the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following: (1) Mitigating Factors: (a) The licensee’s, registrant’s, or permit holder’s lack of a prior disciplinary record; (b) The licensee, registrant, or permit holder self-reported the violation to the Board; (c) The licensee’s, registrant’s, or permit holder’s full and voluntary admission of misconduct to the Board and cooperation during Board proceedings; (d) The licensee, registrant, or permit holder implemented remedial measures to correct or mitigate harm arising from the misconduct; (e) The licensee, registrant, or permit holder made a timely good-faith effort to make restitution or to rectify the consequences of the misconduct; (f) Evidence of rehabilitation or rehabilitative potential; (g) Absence of premeditation to commit the misconduct; (h) Absence of potential harm to public or adverse impact; and (i) The licensee’s, registrant’s, or permit holder’s conduct was an isolated incident and not likely to recur; and (2) Aggravating Factors: (a) The licensee, registrant, or permit holder has a previous criminal or administrative disciplinary history; (b) The violation was committed deliberately or with gross negligence or recklessness; (c) The violation had the potential for, or caused, serious patient harm; (d) The violation was part of a pattern of detrimental conduct; (e) The licensee, registrant, or permit holder was motivated to perform the violation for financial gain; (f) The vulnerability of the patient or customer; (g) The licensee, registrant, or permit holder attempted to hide error or misconduct from patients or others; (h) Previous attempts at rehabilitation of the licensee, registrant, or permit holder were unsuccessful; and (i) The licensee, registrant, or permit holder committed the violation under the guise of treatment. B. The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter. C. Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. #### Regulation .09 Civil Fines to Pharmacists, Pharmacy Technicians, and Pharmacy Permit Holders. *COMAR 10.34.11.09* A. Practicing on an Expired License. The Board may assess a civil fine against a pharmacist who practices on an expired license in the amount of $1,000 per month of practice past the expiration date of the license, up to a maximum fine of $50,000. B. Working on an Expired Registration. The Board may assess a civil fine against a pharmacy technician or pharmacy intern who works on an expired registration in the amount of $25 per month of practice past the expiration date of the registration, up to a maximum fine of $250. C. Operating a Pharmacy on an Expired Permit. The Board may assess a civil fine against a permit holder that operates a pharmacy on an expired permit in the amount of $5,000 per month of operation past the expiration date of the permit, up to a maximum fine of $50,000. D. Practicing or Operating Without a License, Registration, or Pharmacy Permit. (1) The Board may assess a civil fine of no less than $5,000 and no more than $50,000 against: (a) An individual who practices pharmacy without a license; or (b) An individual or entity that operates a pharmacy without a permit. (2) The Board may assess a civil fine of no less than $250 and no more than $50,000 against an individual who works as an unregistered pharmacy technician or unregistered pharmacy intern. (3) Factors in determining the amount of a fine include, but are not limited to, the following: (a) The extent to which the individual or entity derived any financial benefit from the unauthorized practice or operation; (b) The willfulness of the unauthorized practice or operation; (c) Actual or potential public harm caused by the unauthorized practice or operation; and (d) The length of time in which the individual or entity engaged in the unauthorized practice or operation. #### Regulation .10 Civil Fines to Wholesale Distributor Permit Holders. *COMAR 10.34.11.10* A. Operating on an Expired Wholesale Distributor Permit. The Board may assess a civil fine against a permit holder that operates on an expired wholesale distributor permit in the following amount: (1) A maximum of $10,000 per month of operation past the expiration date of the permit, if the annual gross receipts in Maryland of the permit holder for the previous tax year were less than $10,000,000, up to a maximum fine of $500,000; or (2) A maximum of $25,000 per month of operation past the expiration date of the permit, if the annual gross receipts in Maryland of the permit holder for the previous tax year were $10,000,000 or more, up to a maximum fine of $500,000. B. Practicing Without a License. (1) The Board may assess a civil fine of no less than $10,000 and no more than $500,000 against an individual or entity that operates a wholesale distributor without a license. (2) Factors in determining the amount of a fine include, but are not limited to, the following: (a) The size of the wholesale distributor; (b) The gravity of the violation for which the fine is to be imposed; (c) The good faith of the wholesale distributor; (d) Any previous violations by the wholesale distributor; (e) Actual or potential public harm caused by the unauthorized operation; and (f) The length of time in which the entity engaged in the unauthorized operation. #### Regulation .11 Payment of a Penalty. *COMAR 10.34.11.11* A. A licensee, registrant, or permit holder shall pay to the Board a penalty imposed under this chapter within 30 days of the date the Board's order is issued, unless the Board's order specifies otherwise. B. Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §12-316, 12-412, or 12-601, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board pursuant to this chapter. C. If a licensee, registrant, or permit holder fails to pay, in whole or in part, a penalty imposed by the Board pursuant to this chapter, the Board may not restore, reinstate, or renew a license, registration, or permit until the penalty has been paid in full. D. In its discretion, the Board may refer cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. E. Deposit of Monies. (1) The Board shall pay monies collected pursuant to this chapter, except for civil fines collected under Regulation .09 of this chapter, into the State's General Fund. (2) Civil Fines. (a) The Board shall pay civil fines collected under Regulation .09 of this chapter into the State Board of Pharmacy Fund, in accordance with Health Occupations Article, §12-707(e)(2), Annotated Code of Maryland. (b) The Board shall pay civil fines collected under Regulation .10 of this chapter into the State’s General Fund. ### Chapter 12 — Removal of Expired Medications **Authority:** Health Occupations Article, §12-205, Annotated Code of Maryland **Administrative History:** Effective date: April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Regulation .01 amended effective July 1, 2010 (37:10 Md. R. 722) #### Regulation .01 Manufacturer's Expiration Date. *COMAR 10.34.12.01* A. A wholesale distributor, pharmacist, or pharmacy shall distribute or hold for sale medications bearing a manufacturer's expiration date pursuant to 21 C.F.R. §211.137. B. A wholesale distributor, pharmacist, or pharmacy shall have adequate and credible provisions for return of outdated drugs, including but not limited to partials, through its wholesaler distributor or reverse distributor. ### Chapter 13 — Reinstatement of Expired Licenses for Pharmacists **Authority:** Health Occupations Article, §12-310, Annotated Code of Maryland **Administrative History:** Effective date: April 9, 1984 (11:7 Md. R. 625) **Administrative History:** Recodified from COMAR 10.34.15 to 10.34.13 **Administrative History:** Regulation .01 amended effective September 5, 1988 (15:18 Md. R. 2152) **Administrative History:** Regulation .01B amended effective October 24, 1994 (21:21 Md. R. 1814); November 1, 1999 (26:22 Md. R. 1693); February 17, 2003 (30:3 Md. R. 180); July 1, 2010 (37:10 Md. R. 722) **Administrative History:** Regulation .02 amended effective October 24, 1994 (21:21 Md. R. 1814) **Administrative History:** Regulation .03 amended effective February 19, 1990 (17:3 Md. R. 299); October 24, 1994 (21:21 Md. R. 1814) **Administrative History:** Regulation .03B, C amended effective September 5, 1988 (15:18 Md. R. 2152) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective November 1, 1999 (26:22 Md. R. 1693) **Administrative History:** Regulation .03 amended effective July 1, 2010 (37:10 Md. R. 722) **Administrative History:** Regulation .03B amended effective October 14, 2002 (29:20 Md. R. 1589); February 17, 2003 (30:3 Md. R. 180) **Administrative History:** Regulation .04 adopted effective February 19, 1990 (17:3 Md. R. 299) **Administrative History:** Regulation .04 amended effective July 1, 2010 (37:10 Md. R. 722) **Administrative History:** Regulation .04 amended as an emergency provision effective January 7, 2022 (49:4 Md. R. 299); emergency status expired effective July 6, 2022 #### Regulation .01 Definitions. *COMAR 10.34.13.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “MPJE” means the Multistate Pharmacy Jurisprudence Examination. (3) “NAPLEX” means the North American Pharmacist Licensure Examination. (4) “Reinstatement” means renewal of a license after the license has expired. (5) “Renewal” means renewing a license before the date of expiration. #### Regulation .02 Reinstatement Fee. *COMAR 10.34.13.02* The reinstatement fee authorized by Health Occupations Article, §12-310(a)(2), Annotated Code of Maryland, shall be as determined in COMAR 10.34.09. #### Regulation .03 Reinstatement Requirements. *COMAR 10.34.13.03* A. General Requirements. A pharmacist who wishes to reinstate an expired license to practice pharmacy shall: (1) Provide evidence of the completed amount of approved continuing education required by the Board in COMAR 10.34.18 in conjunction with the reinstatement application; (2) Provide evidence of good standing in any other state in which the pharmacist has been licensed, if applicable; and (3) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09. B. Specific Requirements. (1) The Board: (a) May reinstate the license of a pharmacist who has actively engaged in the practice of pharmacy in Maryland after the expiration of the pharmacist's license if the pharmacist: (i) Meets the requirements of §A of this regulation; and (ii) Pays the pharmacist reinstatement fee established in COMAR 10.34.09.02; (b) May bring charges against a pharmacist who has practiced without a license; and (c) When determining sanctions for practicing pharmacy without a license under §B(1) of this regulation, shall consider: (i) The length of time during which the pharmacist practiced without a license; and (ii) Any violations of Health Occupations Article, Title 12, Annotated Code of Maryland, committed by the pharmacist during the period of unlicensed practice. (2) A pharmacist not actively engaged in the practice of pharmacy, whose Maryland license expired less than 2 years before applying for reinstatement, shall meet the requirements of §A of this regulation. (3) A pharmacist licensed in another state and actively engaged in the practice of pharmacy in that state, whose Maryland license expired less than 2 years before applying for license reinstatement, shall meet the requirements of §A of this regulation. (4) A pharmacist licensed in another state and actively engaged in the practice of pharmacy in that state, whose Maryland license expired 2 years but less than 5 years before applying for license reinstatement, shall: (a) Meet the requirements of §A of this regulation; (b) Submit evidence satisfactory to the Board which documents the applicant's pharmacy experience during the 2 years immediately preceding the date of the applicant's reinstatement application; and (c) Pass the MPJE. (5) A pharmacist not actively engaged in the practice of pharmacy, whose Maryland license expired more than 2 years but less than 5 years before applying for reinstatement, shall: (a) Meet the requirements of §A of this regulation; and (b) Pass the MPJE. (6) A pharmacist not actively engaged in the practice of pharmacy in another state, whose Maryland license expired more than 5 years but less than 10 years before applying for reinstatement, shall: (a) Meet the requirements of §A of this regulation; (b) Pass the MPJE; and (c) Submit evidence satisfactory to the Board of having performed 1,000 hours of service in a pharmacy with a valid pharmacy permit under the supervision of a licensed pharmacist. (7) A pharmacist not actively engaged in the practice of pharmacy, whose Maryland license expired 10 or more years before applying for reinstatement, shall: (a) Meet the requirements of §A(2) and (3) of this regulation; (b) Pass the MPJE; (c) Submit evidence satisfactory to the Board of having performed 1,000 hours of service in a pharmacy with a valid pharmacy permit under the supervision of a licensed pharmacist; and (d) Pass the NAPLEX. #### Regulation .04 Waiver. *COMAR 10.34.13.04* The Board may waive any of the requirements set forth in Regulation .03 of this chapter in reinstating a pharmacist's expired license. ### Chapter 14 — Opening and Closing of Pharmacies **Authority:** Health Occupations Article, §§12-205 and 12-513, Annotated Code of Maryland **Administrative History:** Effective date: December 3, 1984 (11:24 Md. R. 2069) **Administrative History:** Regulation .01C adopted effective February 19, 1990 (17:3 Md. R. 299) **Administrative History:** Regulations .02E amended effective February 19, 1990 (17:3 Md. R. 299) **Administrative History:** Regulations .01 — .04 repealed and new Regulations .01 — .06 adopted effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Chapter revised effective June 1, 2012 (39:7 Md. R. 493) **Administrative History:** Regulation .01B amended effective July 8, 2013 (40:13 Md. R. 1076); June 26, 2023 (50:12 Md. R. 475) **Administrative History:** Regulation .03 amended effective July 8, 2013 (40:13 Md. R. 1076); June 26, 2023 (50:12 Md. R.475) **Administrative History:** Regulation .04 amended effective July 8, 2013 (40:13 Md. R. 1076) **Administrative History:** Regulation .05 amended effective July 8, 2013 (40:13 Md. R. 1076) #### Regulation .01 Definitions. *COMAR 10.34.14.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Closing of a pharmacy” means a licensed pharmacy will cease operations for more than 7 consecutive days, except when: (a) A licensed pharmacy is destroyed or otherwise rendered inoperable, and the licensed pharmacy is moving its operations to a temporary site in accordance with the Board’s regulations; or (b) A licensed pharmacy is undergoing a change of ownership: (i) That will not result in any cessation of pharmacy operations at the location; and (ii) The anticipated new pharmacy permit holder has submitted a change of ownership application to the Board at least 30 days prior to the change of ownership transaction. (2) “Operational pharmacy” means a pharmacy that is actively compounding, dispensing, or distributing prescription or nonprescription drugs or devices in accordance with Health Occupations Article, §12-101(p), Annotated Code of Maryland. #### Regulation .02 Opening a Pharmacy. *COMAR 10.34.14.02* A. To apply for a pharmacy permit, an applicant shall: (1) Submit an application to the Board on the form that the Board requires; (2) Pay to the Board an application fee set by the Board in COMAR 10.34.09; and (3) Submit to an opening inspection, at which time the applicant shall have, at a minimum, the following: (a) If applicable, a Class A prescription balance and weights, or a prescription balance with equivalent or superior sensitivity; (b) A refrigerator, solely for the storage of medications requiring refrigeration, with a thermometer or a temperature monitoring device; (c) Additional equipment to enable the pharmacy to prepare and dispense prescriptions properly consistent with the pharmacy’s scope of practice; (d) Hot and cold running water; (e) A library of current reference sources, consistent with the pharmacy’s scope of practice, that is accessible to appropriate personnel; (f) A current edition of Maryland Pharmacy Laws; (g) A security system in accordance with COMAR 10.34.05.02; and (h) A pharmacist on the premises during the opening inspection, if prescription drugs are present. B. A pharmacy may not be located in a residence. C. A permit holder who has been issued a pharmacy permit by the Board shall, within 60 days following the initial issuance of the pharmacy permit, have and maintain an operational pharmacy. D. The Board shall inspect a pharmacy after the initial issuance of a pharmacy permit to ensure that the pharmacy is an operational pharmacy. E. If a pharmacy is not an operational pharmacy within 60 days following the initial issuance of a pharmacy permit, the Board shall notify the permit holder of the Board’s intent to rescind the pharmacy permit. F. A permit holder who has been notified of the Board’s intent to rescind the pharmacy permit under this regulation shall return the permit to the Board within 10 days of notification, unless the permit holder submits documentation satisfactory to the Board to show that the pharmacy is an operational pharmacy. G. If a pharmacy permit has been rescinded under this regulation, the permit holder may reapply if application requirements are met. H. The Board may waive any of the requirements set forth in this regulation. #### Regulation .03 Notification of Closing of a Pharmacy. *COMAR 10.34.14.03* A. At least 14 days before a licensed pharmacy’s anticipated date of closing, the pharmacy permit holder shall: (1) Notify the: (a) Board in writing by certified mail, return receipt requested, or hand delivery to the Board’s office, of the day on which the licensed pharmacy will close; (b) Office of Controlled Substances Administration by certified mail, return receipt requested, of the day on which the licensed pharmacy will close; (c) Public by conspicuously posting a notice inside the pharmacy and on the pharmacy’s website of the anticipated day on which the pharmacy will close; and (d) Pharmacy’s customers who pick up a new or refilled prescription via written and verbal communication of the anticipated day on which the licensed pharmacy will close; and (2) Request a closing inspection date. B. The notice shall contain the: (1) Anticipated date of closing; (2) Name and location of the pharmacy to which the closing pharmacy will transfer patient prescriptions and records; and (3) Manner in which a patient may request the closing pharmacy to send the patient’s prescriptions and records to an alternative pharmacy of the patient’s choice. C. Upon notification by a pharmacy permit holder of the proposed date on which a licensed pharmacy will close, the Board or its agent shall schedule a closing inspection to be performed within 14 days, excluding federal and State holidays, of the pharmacy’s closing. #### Regulation .03-1 Notification by Pharmacy Permit Holder of Anticipated Sale of Pharmacy Operations. *COMAR 10.34.14.03-1* A. At least 30 days before a licensed pharmacy’s sale or transfer of its pharmacy operations at the permitted establishment, the pharmacy permit holder shall: (1) Notify the: (a) Board in writing by certified mail, return receipt requested, or hand delivery to the Board’s office; and (b) Office of Controlled Substances Administration by certified mail, return receipt requested; and (2) Request a closing inspection of the pharmacy permit holder’s pharmacy inventory and records. B. The notice shall contain: (1) The anticipated date of the pharmacy permit holder’s sale or transfer of its pharmacy operations; and (2) The name of the anticipated purchaser or transferee of the pharmacy permit holder’s pharmacy operations. C. Upon notification by a pharmacy permit holder of the proposed date on which the licensed pharmacy’s operations will be sold or transferred, the Board or its agent shall schedule a closing inspection of the pharmacy permit holder’s inventory and records to be performed within 14 days, excluding State and federal holidays. D. In the event the purchaser or transferee of the pharmacy’s operations is not issued a new pharmacy permit by the Board on or prior to the date of the sale or transfer of the pharmacy operations that results in the cessation of pharmacy operations, the existing pharmacy permit holder shall immediately provide notice to the public, posted outside the pharmacy and on the pharmacy’s website, including: (1) The anticipated day on which pharmacy operations may resume; and (2) The pharmacy permit holder’s contact information for patients who wish to transfer prescriptions or records to another licensed pharmacy of the patient’s choice. #### Regulation .04 Required Information and Procedure. *COMAR 10.34.14.04* A. At the closing inspection of a licensed pharmacy, the pharmacy permit holder shall provide to the Board, or the Board’s agent, information and documentation required by Regulation .05 of this chapter. B. The pharmacy permit holder shall remove or completely cover indications that the premises was a pharmacy within 30 days after the date the licensed pharmacy ceases to operate as a pharmacy. C. The pharmacy permit holder shall notify prescription drug suppliers to the pharmacy, before ceasing to operate as a pharmacy, of the date that the location will cease to operate as a pharmacy. D. The pharmacy permit holder shall notify the public of the date that the pharmacy will cease to operate as a pharmacy by that date. E. The pharmacy permit holder shall notify the public of the location to which the patients' records have been transferred, by the date the pharmacy ceases to operate. F. If patient records are not transferred, the pharmacy permit holder shall notify the public of the: (1) Location of the patient records; (2) Method by which the patient records shall be maintained; and (3) Procedure by which patients and other authorized individuals or entities may access the patient records. G. The pharmacy permit holder shall comply with all federal and State laws and regulations. H. If the Board’s agent performs the closing inspection, the Board’s agent shall obtain information and documentation required by Regulation .05 of this chapter. #### Regulation .05 Information and Documentation Due at the Closing Inspection. *COMAR 10.34.14.05* Information and documentation due at the closing inspection shall include: A. The exact date on which the pharmacy ceased to operate as a pharmacy; B. A copy of the inventory required by the Drug Enforcement Administration; C. The pharmacy permit and Maryland Department of Health controlled dangerous substance registration for cancellation; D. The names, address, telephone numbers, and Drug Enforcement Administration registration numbers of the persons or business entities to whom any prescription drugs in stock were returned or transferred under Regulation .05 of this chapter and for any prescription files or patient records transferred; E. If prescription drugs are destroyed pursuant to Regulation .06 of this chapter, and Regulation .07 of this chapter does not apply to the prescription drugs, the pharmacy permit holder shall provide the Board with a letter, signed under oath by the pharmacy permit holder, stating the: (1) Date, place and manner in which the prescription drugs were destroyed; (2) Names, addresses, and telephone numbers of the persons responsible for destroying the prescription drugs; and (3) Name, dosage unit, and quantity of each type of prescription drug destroyed; F. If any patient records which are not required to be maintained by law, or other documents containing patient information are destroyed, the pharmacy permit holder shall provide the Board with a letter, signed under oath by the pharmacy permit holder, stating: (1) That the documents were destroyed; (2) The date of the destruction of the documents; (3) The name and address of the person who destroyed the documents; (4) That the records or other documents were destroyed in a manner so as to avoid breaches of patients' confidentiality; and (5) The identity of the records destroyed; and G. If any patient records or other documents containing patient information are transferred, the pharmacy permit holder shall provide the Board with a letter, signed under oath by the pharmacy permit holder, stating: (1) The date, time, place to which and manner in which the records or other documents were transferred; (2) The names, addresses, and telephone numbers of the persons responsible for transferring the records or other documents; (3) That the records or other documents were transferred in a manner so as to avoid breaches of patients' confidentiality; and (4) The identity of the records transferred. #### Regulation .06 Disposition of Prescription Drugs Other than Controlled Dangerous Substances. *COMAR 10.34.14.06* With the exception of controlled dangerous substances, prescription drugs in stock shall be disposed of by one or more of the following means: A. Returning them to a distributor or manufacturer; or B. Transferring them to another licensed pharmacy, authorized prescriber, or other person or entity approved by the Board or the Division of Drug Control. #### Regulation .07 Disposition of Controlled Dangerous Substances. *COMAR 10.34.14.07* The pharmacy permit holder shall comply with the procedures set forth in this chapter in addition to those set forth in COMAR 10.19.03.10C — E governing the disposal of controlled dangerous substances. ### Chapter 15 — Licensure by Reciprocity **Authority:** Health Occupations Article, §§12-205 and 12-305, Annotated Code of Maryland **Administrative History:** Effective date: December 3, 1984 (11:24 Md. R. 2069) **Administrative History:** Chapter recodified from COMAR 10.34.18 to 10.34.15 **Administrative History:** Regulation .01 amended effective April 16, 1990 (17:7 Md. R. 849) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective April 6, 1998 (25:7 Md. R. 527) **Administrative History:** Regulation .01 amended as an emergency provision effective January 7, 2022 (49:4 Md. R. 299) ); emergency status expired effective July 6, 2022 **Administrative History:** Regulation .01A amended effective July 1, 2010 (37:10 Md. R. 722) #### Regulation .01 Requirements. *COMAR 10.34.15.01* A. An individual applying for licensure as a pharmacist by reciprocity shall: (1) Submit to the Board an application on a form provided by the Board; (2) Pay to the Board the fee as specified in COMAR 10.34.09; (3) Submit to the Board evidence of completion of at least 520 hours of pharmacy experience after graduation from a school or college of pharmacy approved by the Board or accredited by the American Council on Pharmaceutical Education; (4) Pass the MPJE; and (5) Pass the exam of oral English competency described in COMAR 10.34.02. B. The Board shall waive the requirements of §A(5) of this regulation if the candidate for licensure by reciprocity submits to the Board written documentation that the candidate has passed an equivalent oral English competency exam in another state that was required by the other state's licensing procedures. ### Chapter 16 — Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies **Authority:** Health Occupations Article, §12-205, Annotated Code of Maryland **Administrative History:** Effective date: September 6, 1999 (26:18 Md. R. 1376) **Administrative History:** Regulations .01—.04 amended effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulations .05 and.06 adopted effective April 16, 2001 (28:7 Md. R. 690) #### Regulation .01 Definitions. *COMAR 10.34.16.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Committee” means, in this chapter, a joint committee of representatives from the Board of Pharmacy and the Board of Nursing. (2) “Portable drug kit” means a container comprising prescription drugs and other emergency medical supplies or drugs for use in licensed home health and licensed hospice settings, and by home infusion providers licensed as residential services agencies. (3) “Prescription protocol” means an order for a portable drug kit signed by the medical director of a licensed home health agency, licensed general hospice, or a home infusion provider licensed as a residential services agency. #### Regulation .02 Requirements for Prescription Protocol. *COMAR 10.34.16.02* Before distributing a portable drug kit, the pharmacist shall ensure that the prescription protocol includes: A. The name, strength, and quantity of a drug to be included in the portable drug kit; B. The name of the receiving agency or designated agent; C. The directions for use; D. Conditions for use; E. Contraindications for use; and F. The signature, printed name, and telephone number of the physician authorizing the kit. #### Regulation .03 Records. *COMAR 10.34.16.03* A pharmacist shall: A. File the prescription protocol in a readily retrievable manner; B. Document the: (1) Date of distribution of the portable drug kit, (2) Name of the person or agency to whom the kit is delivered, and (3) Date of delivery for each kit distributed; C. File an administration record for all drugs administered from a kit upon return of the kit to the pharmacy; and D. Notify the Board of Pharmacy before distributing portable drug kits under this chapter. #### Regulation .04 Requirements of the Portable Drug Kit. *COMAR 10.34.16.04* A. The pharmacist shall ensure that the portable drug kit: (1) Is sealed with a tamper evident tag or other means for detecting entry to the kit; (2) Displays on the outside of the kit: (a) A serial number unique to the kit; (b) An expiration date which reflects the earliest expiration date of any item contained in the kit; (c) The contents of the kit; (d) That the contents are or are not sterile; (e) The legend “To be returned to the pharmacy within 5 days of breaking seal, with a completed administration record or prescription enclosed”; and (f) Storage requirements for the contents; (3) Contains: (a) Only prescription drugs and nonprescription items approved for the kit by a committee as defined in Regulation .01B(1) of this chapter; (b) A temperature monitor to indicate maintenance of proper storage conditions; and (c) A written administration record to be completed by the licensed health care provider using the kit, which includes the administration record indicating: (i) The name of the patient, (ii) The name of the prescriber, (iii) Drug name, form, and dosage, (iv) Date the drug was used or wasted, (v) The reason for administration or wastage of the drug, and (vi) The name of the licensed health care provider utilizing the kit; (4) Displays or includes written information inside the kit listing contraindications to use of the kit; and (5) Does not contain a controlled dangerous substance. B. A pharmacist shall only distribute a portable drug kit which complies with the requirements of this chapter. #### Regulation .05 Contents of Portable Drug Kit. *COMAR 10.34.16.05* The committee shall review annually the approved prescription drugs and nonprescription items to ensure that the contents of a portable drug kit are appropriate. #### Regulation .06 Distribution of Portable Drug Kits. *COMAR 10.34.16.06* Portable drug kits may only be distributed to licensed health care providers who are authorized by law to administer the contents of a portable drug kit. ### Chapter 17 — Waiver of Full Service Requirements for Recognized Pharmaceutical Specialties **Authority:** Health Occupations Article, §12-403, Annotated Code of Maryland **Administrative History:** Effective date: June 15, 1987 (14:12 Md. R. 1350) **Administrative History:** Regulation .04A amended effective January 17, 1994 (20:1 Md. R. 34) **Administrative History:** Chapter revised effective October 19, 2009 (36:21 Md. R. 1591) #### Regulation .01 Definitions. *COMAR 10.34.17.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Comprehensive care facility” means a facility which admits patients suffering from disease, disabilities, or advanced age, requiring medical service and nursing service rendered by or under the supervision of a registered nurse. (3) “Continuing care in a retirement community” means providing shelter and providing either medical and nursing or other health related services or making the services readily accessible through the provider or an affiliate of the provider, whether or not the services are specifically offered in the written agreement for shelter: (a) To an individual who is 60 years old or older and not related by blood or marriage to the provider; (b) For the life of the individual or for a period exceeding 1 year; and (c) Under one or more written agreements that require a transfer of assets or an entrance fee notwithstanding periodic charges. (4) “Full service pharmacy” means a pharmacy that provides complete pharmaceutical services to the general public and does not restrict or limit its services to any group of individuals. (5) Pharmaceutical Specialty. (a) “Pharmaceutical specialty” means a limited pharmaceutical service provided by a pharmacy that: (i) Is in or makes use of a specialized setting by virtue of certain equipment, systems, location, or physical structure; and (ii) Restricts or limits its services to a group or groups of individuals requiring such specialty services. (b) “Pharmaceutical specialty” includes the following services: (i) Assisted living facilities; (ii) Comprehensive care facilities; (iii) Developmental disabilities facilities; (iv) Home infusion; (v) Inpatient hospital; (vi) Nonsterile compounding; (vii) Nuclear pharmaceutical; (viii) Research; (ix) Sterile compounding; (x) Veterinary care; (xi) Provision of pharmaceutical services across all settings of care within a continuing care in a retirement community; and (xii) Other services approved by the Board. (6) “Waiver pharmacy” means a pharmacy that has been issued a waiver permit by the Board. #### Regulation .02 Pharmaceutical Specialty. *COMAR 10.34.17.02* A. The Board may recognize as a pharmaceutical specialty not listed under Regulation .01B(4) of this chapter, upon written application and supporting documentation to the Board by an applicant for a waiver permit. B. When evaluating an application for a waiver pharmacy, the Board shall consider whether: (1) The pharmaceutical specialty service is necessary to meet a specific therapeutic need; (2) The location is accessible without endangering public health and safety; (3) The pharmacy is properly equipped to perform the pharmaceutical specialty; (4) The applicant has provided a full and detailed description of the pharmaceutical specialty that clearly substantiates the basis for the request of a waiver permit; and (5) A policy and procedure manual is included with the application which sets forth a detailed description of the pharmacy operation. C. No one criterion or combination of criteria listed in §B of this regulation shall be binding upon the Board. D. The Board's determination of whether a limited practice or setting constitutes a pharmaceutical specialty is final. #### Regulation .03 Requirements of a Waiver Pharmacy. *COMAR 10.34.17.03* A. The Board shall issue a waiver permit to an applicant that: (1) Meets the requirements of this chapter; and (2) Performs pharmaceutical specialty services: (a) Listed in Regulation .01B(4) of this chapter; or (b) Approved by the Board. B. The applicant shall: (1) Submit an application form approved by the Board; (2) Pay a fee as set forth in COMAR 10.34.09; (3) Submit any other documentation as required by the Board; (4) Employ at least one pharmacist at the applicant's proposed facility who has received education or training in the pharmaceutical specialty in addition to that required for licensure; and (5) Notify the Board in writing within 30 days of any change in the information given on the initial or renewal waiver pharmacy application. #### Regulation .04 Restricted Practice. *COMAR 10.34.17.04* A. A waiver pharmacy is restricted to the pharmaceutical specialty services approved by the Board in the waiver permit. B. A waiver pharmacy may not perform functions of a full service pharmacy. C. A full service pharmacy may perform pharmaceutical specialty services as long as the full service pharmacy is able to demonstrate competency in performing the pharmaceutical specialty. D. A full service pharmacy and a waiver pharmacy may operate on the same premises provided that the full service pharmacy and the waiver pharmacy: (1) Obtain separate permits from the Board; (2) Are supervised by separate licensed pharmacists who are responsible for the operations of their respective pharmacies at all times the pharmacies are in operation; and (3) Maintain separate inventory and record keeping for each pharmacy permit. ### Chapter 18 — Continuing Education for Pharmacists **Authority:** Health Occupations Article, §§12-205 and 12-309, Annotated Code of Maryland **Administrative History:** Effective date: August 8, 1988 (15:16 Md. R. 1915) **Administrative History:** Regulation .06A amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .07 amended effective July 3, 1995 (22:13 Md. R. 967) **Administrative History:** Regulation .08 adopted effective November 3, 1997 (24:22 Md. R. 1552) **Administrative History:** Chapter revised effective July 1, 2010 (37:10 Md. R. 722) **Administrative History:** Regulation .01-1 adopted effective April 30, 2012 (39:8 Md. R. 536) **Administrative History:** Regulation .03C amended effective June 5, 2017 (44:11 Md. R. 525) #### Regulation .01 Scope. *COMAR 10.34.18.01* These regulations govern any person who desires to renew a license to practice pharmacy in Maryland. #### Regulation .01-1 Definitions. *COMAR 10.34.18.01-1* A. In this chapter, the following term has the meaning indicated. B. Live Instruction. (1) “Live instruction” means a course offering the ability for the participant to have real-time interaction with the presenter. (2) “Live instruction” includes programs approved by the American Council on Pharmaceutical Education (ACPE) that are designated by the letter “L” in the course identification number. #### Regulation .02 Exceptions. *COMAR 10.34.18.02* A. This chapter does not apply to pharmacists applying for renewal for the first renewal period following the issuance of the original license, if the pharmacist obtains a license within 1 year of the completion of the pharmacist's pharmaceutical education. B. The Board may grant an exception from the continuing education requirements if the pharmacist presents evidence that failure to comply was due to circumstances beyond the pharmacist's control. #### Regulation .03 Requirements for Pharmacists Practicing in Maryland. *COMAR 10.34.18.03* A. A pharmacist license expires on the last day of the pharmacist's birth month every other year. B. Before the expiration date of the pharmacist's license, the pharmacist shall: (1) File a renewal application; (2) Pay any applicable fees; and (3) Earn continuing pharmaceutical education (CE) credits required by this chapter. C. CE Requirements. (1) A pharmacist licensed to practice in Maryland applying for renewal shall: (a) Earn 30 hours of approved CE within the 2-year period immediately preceding the license expiration date that include: (i) 1 hour on the topic of preventing medication errors, such as appropriate dispensing of opioids; and (ii) 2 hours of CE obtained through live instruction; (b) Attest to the fact that the pharmacist has completed the CE requirement on a Board approved form; and (c) Retain supporting documents for inspection by the Board for 4 years after the date of renewal for which the CE credits were used. (2) A pharmacist certified to administer vaccinations in Maryland applying for renewal shall: (a) As part of the 30 hours of approved CE requirement, complete 4 hours of CE credits related to vaccinations; or (b) If registered to administer vaccines before October 1, 2008 for the first renewal of the registration after that date, demonstrate that 4 CE credits taken include education about the herpes zoster and pneumococcal pneumonia vaccines. #### Regulation .04 Requirements for Pharmacists Not Practicing in Maryland. *COMAR 10.34.18.04* A licensed pharmacist not practicing in Maryland shall fulfill the continuing education requirements of Maryland. #### Regulation .05 Requirements for Pharmacists who are Authorized Prescribers. *COMAR 10.34.18.05* A pharmacist who is also an authorized prescriber licensed by a board (in Maryland or another state) may use the continuing education (CE) credits applied toward that board toward the Board of Pharmacy's CE requirements. #### Regulation .06 Accredited Continuing Education Programs. *COMAR 10.34.18.06* A. The Board and the following providers are approved for any programs they offer which otherwise qualify for continuing education (CE) credit: (1) American Council on Pharmaceutical Education (ACPE); (2) Schools of pharmacy accredited by ACPE; (3) Food and Drug Administration (FDA); (4) Drug Enforcement Administration (DEA); and (5) Additional providers of programs approved by the Board. B. Procedures for Approval of Additional Programs. (1) An additional provider shall request approval for an individual program by submitting a Board application at least 60 days before the date of offering of their individual program. (2) An approval request shall fulfill the program requirements set forth in Health Occupations Article, §12-309(g), Annotated Code of Maryland. (3) An approval request shall include a description of course work including: (a) Measurable learning objectives; (b) A course outline; and (c) Self-assessment questions. (4) The Board's decision to approve or disapprove a program is final. C. Record Keeping for Providers of Approved Programs. (1) Providers of approved programs shall maintain program records for 3 years from the date of presentation of the program. (2) Providers of approved programs of CE shall furnish a certificate of completion to participants who qualify. The provider shall include the: (a) Name of the participant; (b) Name of the provider; (c) Title of the course; (d) Number of CE hours; (e) Date of completion; and (f) A program identification number or provider number on the certificate. D. The Board may rescind approval of a CE program if it determines that the program no longer meets the requirements of Health Occupations Article, §12-309, Annotated Code of Maryland. #### Regulation .07 Acceptance of Previously Unapproved Continuing Education Programs. *COMAR 10.34.18.07* A. A pharmacist who completes a program of continuing education that is not previously approved by the Board may request in writing that the Board approve the program for credit. B. The pharmacist making a request for Board approval under §A of this regulation shall make the request at least 90 days before licensed expiration. #### Regulation .08 Miscellaneous. *COMAR 10.34.18.08* A. Credits may not be carried over from one licensing renewal period to another. B. Falsifying continuing education CE records is grounds for disciplinary action. C. The pharmacist shall use a Board approved form to supply the pharmacist's CE information to the Board. D. CE requirements imposed by the Board upon a pharmacist as part of an informal action, consent order, or final order, as defined in COMAR 10.34.01.02, shall be in addition to the requirements of this chapter. E. Pharmacists may receive 2 CE credits for attending a public Board meeting in its entirety. (1) The Board shall issue a certificate of proof of attendance at a public Board meeting. (2) A pharmacist may not earn more than 4 CE credits per renewal period for attendance of a public Board meeting. ### Chapter 19 — Sterile Pharmaceutical Compounding **Authority:** Health Occupations Article, §§12-205, 12-403, 12-503, 12-505, 12-6C-01, and 12-6C-03, Annotated Code of Maryland **Administrative History:** Effective date: February 19, 1990 (17:3 Md. R. 299) **Administrative History:** Regulation .04B amended effective July 20, 1992 (19:14 Md. R. 1284) **Administrative History:** Regulation .05 amended effective July 20, 1992 (19:14 Md. R. 1284) **Administrative History:** Regulations .01 — .06 repealed and new Regulations .01 — .16 adopted effective September 10, 2007 (34:18 Md. R. 1580) **Administrative History:** Regulation .01 amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .02 amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .03B amended effective February 23, 2009 (36:4 Md. R. 354); February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .05A amended effective February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .06A amended effective February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .06A, D amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .07A amended effective February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .09 amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .09A amended effective February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .10 amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .11 amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .13 amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .14E amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .15C, E amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .16A amended effective February 23, 2009 (36:4 Md. R. 354) **Administrative History:** Regulation .17 adopted effective February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .18 adopted effective February 1, 2016 (43:2 Md. R. 127) **Administrative History:** Regulation .19 adopted effective February 1, 2016 (43:2 Md. R. 127) #### Regulation .01 Scope. *COMAR 10.34.19.01* This chapter applies to a licensed pharmacy in Maryland engaging in: A. Compounding or mixing sterile prescription solutions or suspensions to be administered parenterally or by irrigation, inhalation, or intraocular routes; and B. Compounding of radiopharmaceuticals, except where U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations addresses radiopharmaceuticals, U.S. Pharmacopeia (USP) Chapter 821 Radioactivity, and U.S. Pharmacopeia (USP) Chapter 823 Radiopharmaceuticals for Positron Emission Tomography — Compounding would apply. #### Regulation .02 Incorporation by Reference. *COMAR 10.34.19.02* In this chapter, the following documents are incorporated by reference: A. U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations (USP 797 Standards), which has been incorporated by reference in 21 U.S.C. §351(b) (as amended). B. U.S. Pharmacopeia (USP) General Chapter 795 Pharmaceutical Compounding — Non-Sterile Preparations (USP 795 Standards), which has been incorporated by reference in 21 U.S.C. §351(b) (as amended). C. U.S. Pharmacopeia (USP) Chapter 821 Radioactivity, which has been incorporated by reference in 21 U.S.C. §351(b) (as amended). D. U.S. Pharmacopeia (USP) Chapter 823 Radiopharmaceuticals for Positron Emission Tomography — Compounding, which has been incorporated by reference in 21 U.S.C. §351(b) (as amended). #### Regulation .03 Definitions. *COMAR 10.34.19.03* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adverse event” means: (a) Any adverse patient outcome related to the sterile compounding process; or (b) Evidence of environmental contamination, including microbial contamination above the threshold set forth in USP 797 Standards. (2) “Antineoplastic” means an agent that prevents the development, growth, or proliferation of malignant cells. (3) “Anteroom” means the area, room, or rooms where personnel perform hand hygiene and garbing immediately adjacent to the designated clean room where the compounding of sterile preparations is performed. (4) Batch. (a) “Batch” means a preparation compounded in advance of receipt of a prescription, or a preparation compounded in a supply that will be used on more than one dispensing to a patient or patients or any preparation compounded in excess of the filling of an individual prescription. (b) “Batch” includes a limited quantity of identical preparations compounded in a single, discrete process, by the same individuals, carried out during one limited time period. (5) “Biological safety cabinet” means a containment unit: (a) Suitable for work involving agents that pose higher risk of exposure to operators during compounding; and (b) Used when there is a need for protection of the preparation, personnel, and environment. (6) “Clean room” means a room with an International Standards Organization (ISO) Class 5 environment or an ISO Class 7 environment that meets USP 797 Standards, inside which compounding occurs within an ISO Class 5 engineering control device such as a laminar airflow workstation or a biological safety cabinet. (7) “Closed system vial transfer device (CSTD)” means a closed system drug transfer device that mechanically, not by means of vents or filters, prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug aerosols or vapors into the environment. (8) “Compounded sterile preparation” means sterile medication preparations, such as intravenous, epidural, and intraocular medications, compounded in the pharmacy using currently accepted aseptic compounding techniques under acceptable compounding conditions. (9) “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug: (a) As the result of a practitioner’s prescription drug order or initiative based on the practitioner/patient relationship in the course of professional practice; (b) For the purpose of, or incidental to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device; or (c) In anticipation of a prescription drug order based on routine, regularly observed prescribing patterns. (10) “Compounding aseptic isolator” means an enclosed positive or negative pressure environment especially designed for sterile preparation compounding that maintains a physical barrier between the workspace and the operator. (11) “Controlled environment” means a designated area for compounding sterile preparations that consists of a clean room and an anteroom. (12) “Cytotoxic” means drug entities that are damaging or debilitating to cells, tissues, or organs. (13) “Designee” means a public agency or private entity trained in: (a) USP 797 Standards; (b) FDA good manufacturing practices approved by the Board to conduct inspections of nonresident pharmacies that perform sterile compounding; or (c) Both §B(13)(a) and (b) of this regulation. (14) “Laminar air flow workstation” means an ISO Class 5 (“Class 100”) laminar airflow hood inside which sterile compounding occurs. (15) “Media fill verification” means a process of practical examination to verify the aseptic technique of personnel or an aseptic process by manual manipulation of microbiological growth media which simulates compounding processes and techniques used in actual compounding procedures. (16) “Parenteral” means routes of drug administration or fluid administration other than via the gastrointestinal tract. (17) “Pharmacist” means an individual who is licensed to practice pharmacy regardless of the location where the activities of practice are performed. (18) “Pharmacy” means an establishment in which prescription or nonprescription drugs or devices are compounded, dispensed, or distributed. (19) “Pyrogen testing” means an analysis of sterile preparations for the presence of cell material from microbiological organisms in sufficient quantity to elicit a febrile reaction. (20) “Risk level” means a risk level of low, medium, or high as defined in USP 797 Standards. (21) “Sterile” means free from living microorganisms or any other contaminants. (22) “Sterile compounding” means compounding of biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that, under USP 797 Standards, are prepared using aseptic techniques. (23) “Total parenteral nutrition” means providing caloric needs by the parenteral route for a patient who is unable to ingest sufficient calories. (24) “USP 795 Standards” means standards set forth in the US Pharmacopeia (USP) General Chapter 795 Pharmaceutical Compounding — Non-Sterile Preparations. (25) “USP 797 Standards” means standards set forth in the U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding — Sterile Preparations. #### Regulation .04 Pharmacy Environment. *COMAR 10.34.19.04* The compounding, preparation, and dispensing of compounded sterile preparations shall be accomplished in a pharmacy environment subject to State and federal laws, regulations, and standards. #### Regulation .05 General Requirements. *COMAR 10.34.19.05* A licensed pharmacist who has appropriate practical and didactic training in compounding sterile preparations, clean room technology, laminar flow technology, quality assurance techniques, and clinical application of intravenous drug therapy shall control and supervise the section of the pharmacy that prepares compounded sterile preparations and is responsible for, at a minimum, the following: A. Preparation of compounded sterile preparations within the pharmacy or decentralized pharmacy; B. Storage of materials pertinent to the preparation of compounded sterile preparations, including drugs, chemicals, and biologicals, and the establishment of specifications for procurement of the materials; C. Labeling of containers of compounded sterile preparations compounded within the pharmacy; D. Recording of transactions of the pharmacy as may be applicable to State and federal laws and regulations, as may be necessary to maintain accurate control over, and accountability for, pharmaceutical materials; and E. Ensuring that licensed pharmacists meeting the requirements of §A of this regulation, or registered pharmacy technicians under direct supervision of a licensed pharmacist meeting the requirements of §A of this regulation, prepare, compound, and dispense compounded sterile preparations. #### Regulation .06 Special Handling, Packaging, Labeling, and Beyond Use Dating. *COMAR 10.34.19.06* A. The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during handling and administration to the patient including: (1) A reasonable effort to provide tamper-evident packaging if appropriate to setting; (2) Proper in-transit storage consistent with preparation labeling; and (3) Delivery to the patient within a reasonable time. B. The dispensed container for any compounded sterile preparation shall include labeling according to Maryland law and regulations, in addition to the following information that is required by federal law: (1) The date of preparation unless otherwise readily retrievable from prescription records; (2) Time prepared, if applicable; (3) The pertinent requirements for proper storage; (4) The name of the prescriber, unless in an inpatient hospital setting; (5) The name of the patient; (6) Directions for use; (7) The name of the base solution for infusion preparations; (8) The name and concentration or amount of active drugs contained in the final sterile preparation; (9) The name or identifying initials of the pharmacist who checked or prepared the compounded sterile preparation unless otherwise readily retrievable from prescription records; (10) The name, address, and telephone number of the pharmacy unless in an inpatient hospital facility; (11) The beyond-use/expiration dating and time of the compounded sterile preparation, and if no time is stated, the time is presumed to be at 11:59 p.m. of the stated beyond use date; (12) Any ancillary and cautionary instructions as needed; and (13) A pertinent warning consistent with applicable federal and State law that cytotoxic preparations are biohazardous, when applicable. C. A pharmacy compounding sterile infusion preparations shall provide a 24-hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists. D. Expiration or Beyond-Use Dating. In the absence of direct testing evidence, as detailed in the Stability Criteria and Beyond Use Dating section of USP 795 Standards, the pharmacist shall use “beyond-use dating” as determined by USP 797 Standards and reference materials as cited in Regulation .16 of this chapter. #### Regulation .07 Record-Keeping Requirements. *COMAR 10.34.19.07* A. Patient Prescription Records. (1) The pharmacy shall maintain records of patient prescriptions. (2) Patient prescription records shall contain: (a) Available medical information consistent with prevailing pharmacy standards; and (b) The complete record of the formulations of the solutions that were compounded. (3) The pharmacy shall keep completed patient prescription records in a retrievable manner for at least 5 years, either: (a) At the inspection site; or (b) So as to be immediately retrievable by computer or other electronic means. B. Compounded Sterile Preparations Records. (1) For a pharmacy preparing compounded sterile preparations, the following records shall be maintained for at least 5 years: (a) The training and competency evaluation of employees in sterile preparation procedures; (b) Refrigerator and freezer temperatures; (c) Certification of the sterile compounding environment, including ISO 5 workstations and the clean and anterooms; (d) Other facility quality control logs specific to the pharmacy's policies and procedures, for example, cleaning logs for facilities and equipment; (e) Records documenting inspection for expired or recalled pharmaceutical preparations or raw ingredients; (f) Preparation records including compounding work sheets, and records of the registered pharmacy technicians' checking/sign-off process; and (g) Preparation records including compounding work sheets and records of the pharmacists' checking/sign-off process. (2) In addition to the records requirement in §B(1) of this regulation, for batch compounded sterile preparations, a pharmacy compounding sterile batch preparations for future use shall have records indicating the: (a) Drug and ingredient names; (b) Lot numbers; (c) Expiration dates; (d) Drug/diluent amounts; and (e) Date on which the compounded sterile batch preparations were prepared. (3) A pharmacy shall maintain records of media fill verification results for 5 years. #### Regulation .08 Batch Preparation. *COMAR 10.34.19.08* A. A pharmacist may prepare batched sterile preparations for future use in limited quantities supported by prior valid prescriptions or physician orders before receiving a valid written prescription or medication order. B. Batch preparation of specific compounded sterile preparations is acceptable if the: (1) Pharmacist can document a history of valid prescriptions or physician orders that have been generated solely within an established professional prescriber-patient-pharmacist relationship; and (2) Pharmacy maintains the prescription on file for such preparations dispensed. #### Regulation .09 Minimum Facility Requirements. *COMAR 10.34.19.09* A. Controlled Environment. (1) The pharmacy shall have a controlled environment that meets USP 797 Standards. (2) A pharmacist shall ensure that the controlled environment is: (a) Accessible only to designated personnel; and (b) Used only for the preparation of compounded sterile preparations, or such other tasks that require a controlled environment. (3) The permit holder shall ensure that the controlled environment is: (a) Structurally isolated from other areas within the pharmacy by means of restricted entry or access; and (b) Air conditioned to maintain a temperature of the controlled environment according to USP 797 standards. B. Controlled Environment — Clean Room. The permit holder shall ensure that the clean room in the controlled environment: (1) Meets USP 797 Standards for design and USP 797 performance criteria quality standards for clean rooms; (2) Contains no sinks or floor drains; (3) Contains work surfaces constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that the work surfaces may be readily cleaned and sanitized; (4) If cytotoxic agents are routinely used in compounding preparations, contains room or rooms equipped with special pressurization requirements consistent with USP 797 Standards and the National Institute for Occupational Safety and Health (NIOSH) standards; (5) Has in place appropriate environmental engineering control devices capable of maintaining USP 797 air-quality standards during normal compounding activity; and (6) Contains the following equipment: (a) A laminar airflow workstation or other suitable International Standards Organization (ISO) Class 5 compounding environment; (b) Waste containers that are approved by Occupational Safety and Health Administration (OSHA) for used needles and syringes, and for chemotherapy waste; and (c) Ancillary supplies required for proper compounding. C. Controlled Environment — Anteroom. The permit holder shall ensure that the anteroom in the controlled environment: (1) Meets USP 797 Standards for design and USP 797 performance criteria quality standards for anterooms; and (2) Contains the following equipment: (a) A sink with hot and cold running water; (b) Waste containers for personal protective equipment; (c) An eyewash station or sink design suitable for flushing an eye injury; and (d) A hazardous waste spill kit, if applicable. D. The requirements specified in §§B(1) and C(1) of this regulation are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with the: (1) Compounding aseptic isolator conditions set forth in USP 797 Standards; and (2) Isolator vendor or manufacturer specifications. #### Regulation .10 Minimum Requirements for Equipment. *COMAR 10.34.19.10* A. The permit holder shall provide at least the following equipment that is maintained in working order: (1) Adequate refrigerator and freezer space (if applicable); (2) A sink and wash area in the anteroom; (3) Appropriate waste containers for: (a) Used needles and syringes; and (b) Cytotoxic waste including disposable apparel used in its preparation, if applicable; (4) Laminar air flow workstation or compounding aseptic isolator that meets USP 797 Standards, dedicated for products other than antineoplastics; (5) If applicable to types of preparations compounded, biological safety cabinet, or compounding aseptic isolator that meets USP 797 Standards, dedicated for use with antineoplastics or other hazardous sterile preparations; (6) Appropriate filters and filtration equipment; and (7) A device for light/dark field examination. B. If used, the permit holder shall provide the following equipment that is maintained in working order, calibrated, or certified where appropriate: (1) Autoclave; (2) Automated compounding devices (for example, total parenteral nutrition compounding pumps); (3) Electronic balance; (4) Convection oven; (5) Thermometers or other temperature device; and (6) Incubator. #### Regulation .11 Minimum Requirements for Supplies. *COMAR 10.34.19.11* A pharmacy engaging in compounding sterile preparations shall maintain adequate stock levels of the following supplies according to USP 797 Standards, including but not limited to: A. Personal protective equipment: (1) Sterile gloves; (2) Masks; (3) Non-shedding gowns; (4) Shoe covers; (5) Hair covers; (6) Beard covers; and (7) Other personal protective equipment; B. Disposable syringes and needles in necessary sizes; C. Disinfectant cleaning agents as specified in USP 797 Standards, including 70 percent sterile isopropyl alcohol; D. Disposable lint free towels; E. Hand washing materials, including antimicrobial skin cleanser; F. Adequate equipment and materials for antineoplastic or cytotoxic agent spills; G. Supplies necessary for the aseptic preparation of compounded sterile preparations; and H. Closed system vial transfer devices (CSTD), as required for cytotoxic compounding, if applicable. #### Regulation .12 Minimum Requirements for Policies and Procedures. *COMAR 10.34.19.12* A. The permit holder shall ensure that the pharmacist or the pharmacist's designee shall maintain a policy and procedure manual, reviewed annually, that sets forth in detail the permit holder's standard operating procedures with regard to compounding sterile preparations. B. The permit holder shall insure that the policy and procedure manual that sets forth the standard operating procedures with regard to compounding sterile preparations is implemented and adhered to. C. The policy and procedure manual shall include policies and procedures governing the following: (1) A risk-management program which includes documentation of outcomes including, but not limited to: (a) An incident reporting system; (b) An adverse drug reaction reporting system; and (c) A preparation contamination reporting system; (2) Security measures ensuring that the premises where sterile compounded preparations are stored and prepared are secured, to prevent access by unauthorized personnel; (3) Equipment including, but not limited to: (a) Procedures for use; (b) Documentation of appropriate certifications; and (c) Documentation of appropriate calibration and preventive maintenance if applicable; (4) Sanitation standards and procedures including monitoring for bacterial microorganisms to demonstrate effectiveness of cleaning activities; (5) Reference materials as set forth in Regulation .16 of this chapter; (6) Information concerning drug: (a) Preparation; (b) Storage and handling; (c) Dispensing; (d) Labeling; (e) Beyond-use/expiration dating; (f) Delivery; (g) Destruction; (h) Recalls; and (i) Returns; (7) Patient record keeping as set forth in Regulation .07 of this chapter; (8) Handling, dispensing, and documentation of investigational drugs; (9) A quality assurance program; (10) Verification of training and competency guidelines; (11) Compounding process media fill verification procedures; (12) Description of appropriate garb; (13) Conduct guidelines for personnel in the controlled areas; (14) Personnel responsibilities; (15) Patient education, if appropriate; (16) Protocol and procedures to maintain the integrity of the interior work area of the laminar air flow workstations; (17) Written procedures as applicable for handling antineoplastic agents and other hazardous substances including: (a) Utilizing the proper equipment and supplies; (b) A statement that compounding shall be conducted within a properly certified biological safety cabinet or negative pressure compounding aseptic isolator; (c) Proper use of protective attire; and (d) Proper techniques to prevent both contamination of the preparation and chemical exposure of the individual preparing the prescription; (18) Written procedures as applicable for the disposal of infectious materials or materials containing cytotoxic residues, or hazardous waste; (19) Written documentation of policy and procedure changes based on data gathered from quality assurance evaluations; and (20) Written documentation of policies and procedures assuring the sterility and stability of compounded sterile preparations. #### Regulation .13 Attire. *COMAR 10.34.19.13* A. When compounding sterile preparations, individuals shall comply with the following standards: (1) Sequencing of garbing that complies with USP 797 Standards; (2) Thorough hand-washing before gowning; (3) Wearing clean room garb inside the designated area at all times, which consists of: (a) A non-shedding coverall or gown; (b) Head and facial hair covers; (c) A face mask; and (d) Shoe covers; (4) Clean room garb, with the exception of sterile gloves, shall be donned and removed outside the designated clean room area; (5) All jewelry shall be removed; (6) Sterile gloves are required; and (7) Make-up may not be worn in the clean room. B. The requirements of this regulation are not applicable if a compounding aseptic isolator is used to compound sterile preparations in accordance with USP 797 Standards and isolator vendor/manufacturer specifications. #### Regulation .14 Training of Staff, Patient, and Caregiver. *COMAR 10.34.19.14* A. The pharmacist shall make counseling available to the patient or primary caregiver, or both, concerning proper use of compounded sterile preparations and related supplies furnished by the pharmacy. B. The permit holder shall ensure that pharmacy personnel engaging in compounding sterile preparations are trained and demonstrate competence in the safe handling and compounding of compounded sterile preparations and parenteral solutions, including cytotoxic agents if applicable. C. The permit holder shall maintain records of training and demonstrated competence for individual employees for 5 years. D. The permit holder shall ensure the continuing competence of pharmacy personnel engaged in compounding sterile preparations. E. A pharmacy that compounds sterile preparations shall comply with the following training requirements: (1) The pharmacy shall establish and follow a written program of training and performance evaluation designed to ensure that individuals working in the designated area have the knowledge and skills necessary to perform the assigned tasks properly and include at least the following: (a) Aseptic technique with media fill verification at a frequency defined by risk level as described in USP 797 Standards: (i) 12 months for low and medium risk; and (ii) 6 months for high risk; (b) Pharmaceutical calculations and terminology; (c) Compounding sterile preparation documentation process; (d) Quality assurance procedures; (e) Aseptic preparation procedures; (f) Proper cleansing, gowning, and gloving techniques; (g) General conduct in the controlled area; (h) Cleaning, sanitizing, and maintaining equipment used in the controlled area; (i) Sterilization techniques for high risk preparations; and (j) Container, equipment, and closure system selection. (2) Individuals assigned to the controlled area shall successfully complete practical skills training in aseptic technique and aseptic area practices. (3) Evaluations shall include: (a) Written testing; (b) Observation for adherence to aseptic technique and aseptic area policies and procedures; and (c) Media fill verification as set forth in §E(1)(a) of this regulation. #### Regulation .15 Quality Assurance. *COMAR 10.34.19.15* The permit holder shall ensure that the compounded sterile preparation retains its potency and sterility throughout the assigned “beyond use” dating period through a written quality assurance program that includes: A. A reasonable effort by the pharmacist to assure that compounded sterile preparations shall be kept under appropriate controlled conditions before dispensing, during transport, and at the location of use by providing adequate labeling and verbal or written instructions regarding proper storage and administration, as set forth by the product manufacturer and established standards and literature, with each compounded sterile preparation dispensed; B. The phases of compounded sterile preparation, distribution, storage, administration, and directions for use for each type of preparation dispensed; C. Environmental sampling for microbial organisms in laminar air flow workstations and clean rooms is performed according to methods and schedules specified by USP 797 Standards and if microbial contamination is suspected, for example, in the event of positive media fill verification results; D. Laminar air flow workstations, biological safety cabinets, and compounding aseptic isolators certified by a trained and qualified operator; E. Clean room and anteroom certification by a trained and qualified operator according to USP 797 Standards; F. The proper disposal in accordance with accepted professional standards and applicable State and federal laws of unused drugs and materials used in the preparation of compounded sterile preparations, including antineoplastic agents and hazardous materials; G. A formal written review process to report and evaluate compliance with this chapter; and H. A process that complies with applicable USP 797 Standards for performing sterility checks or pyrogen testing, or both, for applicable compounded sterile preparations. #### Regulation .16 Reference Library. *COMAR 10.34.19.16* Minimum reference materials in a pharmacy shall include: A. U.S. Pharmaceutical, General Chapter 797, Pharmaceutical Compounding — Sterile Preparations and other applicable reference materials in order to perform sterile compounding; B. Reference materials containing drug stability and compatibility data; and C. Reference materials concerning drug interactions and incompatibility. #### Regulation .17 Minimum Requirements for Inspections. *COMAR 10.34.19.17* A. The Board shall inspect pharmacies located in Maryland at least annually. B. The pharmacy shall provide as part of the inspection process: (1) Quality assurance testing reports; (2) Documentation of reporting adverse events as required in Regulation .18 of this chapter; (3) Microbial testing of a sampling of the sterile compounded preparations of the pharmacy if applicable according to USP 797 Standards; and (4) Any other information requested to ensure compliance with USP 797 Standards. C. Within 90 days before the date of application, inspections of nonresident pharmacies may be conducted by: (1) A designee of the Board; (2) The U.S. Food and Drug Administration; or (3) Another appropriate state entity which indicates compliance with USP 797 Standards. D. The Board or designee shall inspect nonresident pharmacies upon initial application and upon renewal. E. The Board may inspect a pharmacy at any time to: (1) Verify compliance with permit requirements; or (2) Investigate a complaint. #### Regulation .18 Reporting Requirements Pharmacies. *COMAR 10.34.19.18* A pharmacy shall: A. Document and perform routine testing as required by USP 797 Standards for the appropriate risk levels of sterile compounded preparations; and B. Report to the Board within 5 calendar days: (1) Adverse events that have been discovered including corrective actions taken or proposed; (2) Deficiencies related to the sterile compounding process; (3) Disciplinary actions in other states or by other state agencies; (4) Changes in accreditation status; (5) Disciplinary actions taken against a pharmacist who is an owner, operator, or employee of the pharmacy; and (6) Disciplinary actions taken against any other known permit, or any other authorization, held by the pharmacy permit holder. #### Regulation .19 Office Use. *COMAR 10.34.19.19* Unless otherwise authorized, a person that prepares and distributes sterile compounded medications for office use into, out of, or within the State shall hold: A. A manufacturer’s permit or other permit designated by the U.S. Food and Drug Administration to ensure the safety of sterile compounded medications for office use; and B. If applicable, a wholesale distributor’s permit, issued by the Board under Health Occupations Article, Title 12, Subtitle 6C, Annotated Code of Maryland. ### Chapter 20 — Format of Prescription Transmission **Authority:** Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland **Administrative History:** Effective date: December 24, 1990 (17:25 Md. R. 2908) **Administrative History:** Regulation .03 amended effective December 18, 1995 (22:25 Md. R. 1962) **Administrative History:** Regulation .04 amended effective December 18, 1995 (22:25 Md. R. 1962) **Administrative History:** Regulation .05 adopted effective December 18, 1995 (22:25 Md. R. 1962) **Administrative History:** Regulations .01—.05, Prescription Orders Submitted by Facsimile Devices, repealed and Regulations .01—.04, Format of Prescription Transmission, adopted effective December 25, 2000 (27:25 Md. R. 2282) **Administrative History:** Regulation .01 amended effective October 4, 2010 (37:20 Md. R. 1394) **Administrative History:** Regulation .02 amended effective October 4, 2010 (37:20 Md. R. 1394) **Administrative History:** Regulation .03 amended effective October 4, 2010 (37:20 Md. R. 1394) **Administrative History:** Regulation .04 amended effective October 4, 2010 (37:20 Md. R. 1394) #### Regulation .01 Scope. *COMAR 10.34.20.01* This chapter applies to the conveyance or transmission of prescription orders from authorized prescribers to pharmacies in the State. #### Regulation .02 Requirements for Prescription Validity. *COMAR 10.34.20.02* A. A valid prescription shall be: (1) Valid in the professional judgment of the pharmacist responsible for filling the prescription; and (2) Conveyed: (a) In a manner that contains the handwritten, pen-to-paper signature of the prescriber; (b) In a manner that is transmitted to the pharmacy electronically, provided that the prescription is: (i) Transmitted via electronic intermediaries that are certified by the Maryland Health Care Commission; (ii) Received by the permit holder’s computer, facsimile machine, or other electronic device; and (iii) Maintained by the permit holder in accordance with Regulation .03 of this chapter; or (c) In an oral manner where: (i) Only a pharmacist may take an original oral prescription by a voice messaging system or by phone with the pharmacist reading back the prescription to the prescriber or the prescriber’s agent; and (ii) The pharmacist promptly reduces the oral prescription to writing. B. The requirement of §A(2)(b)(i) of this regulation does not apply to prescriptions transmitted electronically within: (1) A closed system of a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland; or (2) Any other closed system that does not utilize an intermediary for transmission of prescriptions. #### Regulation .03 Prescription Records. *COMAR 10.34.20.03* The pharmacy permit holder shall maintain prescription records in a form that: A. Is readily and accurately retrievable; B. Is maintained for at least 5 years from the date of dispensing; and C. Protects the confidentiality and security of the prescription information. #### Regulation .04 Controlled Dangerous Substances. *COMAR 10.34.20.04* Transmission and dispensing of controlled dangerous substances shall be in accordance with applicable State and federal statutes and regulations. ### Chapter 21 — Standard of Practice for Unlicensed Personnel **Authority:** Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland **Administrative History:** Effective date: March 5, 2001 (28:4 Md. R. 419) **Administrative History:** Regulation .02B amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .03 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .03B amended effective December 10, 2001 (28:24 Md. R. 2128) **Administrative History:** Regulation .03E amended effective November 25, 2002 (29:23 Md. R. 1811) **Administrative History:** Regulation .04 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .05 amended effective January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .06 amended effective January 28, 2008 (35:2 Md. R. 127) #### Regulation .01 Scope. *COMAR 10.34.21.01* This chapter establishes standards of practice and the responsibilities of licensed pharmacists and pharmacy permit holders when using unlicensed personnel in the prescription area of a pharmacy. #### Regulation .02 Definitions. *COMAR 10.34.21.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Operational support” means tasks performed by: (a) An administrative clerk; (b) A billing clerk; (c) A cashier; (d) Delivery personnel; (e) A file clerk; (f) An inventory control clerk; or (g) An individual engaged in janitorial services. (3) “Permit holder” means a person or corporation or other legal entity holding a permit issued by the Board to establish and operate a pharmacy. (4) “Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland. (5) “Prescription area” means that portion of an establishment to which a pharmacy permit has been issued, which contains: (a) Prescription drugs; (b) Prescription devices; and (c) Patient records. (6) “Supervision” means the on-site provision of management, direction, oversight, and review of tasks assigned to personnel. (7) “Unlicensed personnel” means individuals employed by the permit holder who provide operational support in the prescription area under the supervision of a licensed pharmacist. #### Regulation .03 Duties of the Permit Holder. *COMAR 10.34.21.03* The permit holder shall: A. Determine which operational support tasks the pharmacist may assign unlicensed personnel to perform in the prescription area; B. Ensure that unlicensed personnel: (1) Receive appropriate training for the tasks that the pharmacist assigns unlicensed personnel to perform in the prescription area; (2) Receive training that will enable unlicensed personnel to understand how the provisions of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland, apply to: (a) Prescription records, and (b) The requirements for confidentiality of patient specific information; and (3) When performing tasks in the prescription area, maintain proper: (a) Sanitation; (b) Hygiene; (c) Biohazard precautions; and (d) Infection control; and C. Ensure that unlicensed personnel are clearly identified to the consumer. #### Regulation .04 Duties of the Pharmacist. *COMAR 10.34.21.04* A. The pharmacist shall provide supervision to unlicensed personnel. B. The pharmacist may not delegate any pharmacy acts to unlicensed personnel. #### Regulation .05 Duties of Unlicensed Personnel. *COMAR 10.34.21.05* A. Unlicensed personnel under the supervision of a pharmacist may perform operational support which the unlicensed personnel have been trained to adequately perform in the prescription area. B. Unlicensed personnel who perform duties in the prescription area shall maintain the confidentiality of patient specific data in accordance with Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland. #### Regulation .06 Grounds for Discipline. *COMAR 10.34.21.06* A. A pharmacist licensee may be subject to discipline if the pharmacist licensee violates any provision of Regulation .04 of this chapter. B. A permit holder may be subject to disciplinary action if: (1) The permit holder fails to take reasonable safeguards to ensure compliance with the regulations of the Board; or (2) The permit holder otherwise violates any of the provisions of Regulation .03 of this chapter. ### Chapter 22 — Licensing of Wholesale Prescription Drug or Device Distributors **Authority:** Health Occupations Article, §§12-205, 12-601, and 12-6C-01 — 12-6C-13, Annotated Code of Maryland **Administrative History:** Effective date: August 31, 1992 (19:17 Md. R. 1607) **Administrative History:** Regulation .03B amended effective November 7, 1994 (21:22 Md. R. 1877) **Administrative History:** Regulation .04 amended effective November 7, 1994 (21:22 Md. R. 1877) **Administrative History:** Regulations .01 — .10 repealed and new Regulations .01 — .09 adopted effective March 28, 2005 (32:6 Md. R. 636) **Administrative History:** Regulations .01 — .09 repealed and new Regulations .01 — .08 adopted effective April 7, 2008 (35:7 Md. R. 748) **Administrative History:** Regulation .02B amended as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529) **Administrative History:** Regulation .02B amended effective July 1, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .03 amended effective July 1, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .03E amended as an emergency provision effective June 18, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529) **Administrative History:** Regulation .03-1 adopted effective July 1, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .05A amended effective July 1, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .09 adopted effective July 1, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .10 adopted effective July 1, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .11 adopted effective July 1, 2014 (41:10 Md. R. 561) #### Regulation .01 Scope. *COMAR 10.34.22.01* This chapter applies to any person engaged in the wholesale distribution of prescription drugs or devices in Maryland. #### Regulation .02 Definitions. *COMAR 10.34.22.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “ANDA” means an Abbreviated New Drug Application number and contains data that, when submitted to the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. (1-1) “Authenticate” means to affirmatively verify, before any wholesale distribution of a prescription drug occurs, that each transaction listed on the pedigree for the prescription drug has occurred. (2) “Authorized distributor of record” means a wholesale distributor with whom a manufacturer has established an ongoing relationship to distribute the manufacturer's prescription drug. (3) “Blood” means whole blood collected from a single donor and processed either for transfusion or further manufacturing. (4) “Blood component” means that part of blood separated by physical or mechanical means. (5) “Board” means the State Board of Pharmacy. (5-1) “Cease to operate” means the date on which the last prescription drug or prescription device is distributed by the permit holder. (5-2) “Central repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services. (6) “Co-licensed partner” means a person in a relationship in which two or more persons have the right to engage in the manufacturing or marketing of a prescription drug, consistent with the U.S. Food and Drug Administration's implementation of the Federal Prescription Drug Marketing Act. (7) “DEA” means the U. S. Drug Enforcement Administration. (8) “Designated representative” means an individual who: (a) Is designated by the wholesale distributor; (b) Serves as the primary contact of the wholesale distributor with the Board; and (c) Is actively involved in, and aware of, the daily operation of the wholesale distributor. (8-1) “Designee” means a Board contracted or Board recognized entity. (9) “Drop shipment” means the sale of a prescription drug: (a) To a wholesale distributor by: (i) The manufacturer of the prescription drug; or (ii) The manufacturer's co-licensed partner, third-party logistics provider, or manufacturer's exclusive distributor; and (b) Through which: (i) The wholesale distributor or a pharmacy warehouse takes title to, but not physical possession of, the prescription drug; (ii) The wholesale distributor invoices the pharmacy, pharmacy warehouse, or other person authorized by law to dispense or administer the prescription drug to a patient; and (iii) The pharmacy, pharmacy warehouse, or other authorized person receives delivery of the prescription drug directly from the manufacturer, the manufacturer's third-party logistics provider, or the manufacturer's exclusive distributor. (10) “FDA” means the U. S. Food and Drug Administration. (11) “Gross receipts” means gross receipts from sales of prescription drugs and devices in the State. (12) Health Care Entity. (a) “Health care entity” means a person that provides diagnostic, medical, surgical, or dental treatment, or chronic or rehabilitative care. (b) “Health care entity” does not include a community pharmacy or a wholesale distributor. (c) “Health care entity” may not simultaneously be a health care entity and a community pharmacy or wholesale distributor. (12-1) “Intracompany sales” means a: (a) Transaction or transfer of prescription drugs between a division, subsidiary, parent, or affiliated or related company under common ownership and control of a corporate entity, other than a transaction or transfer of prescription drugs from a pharmacy to a wholesale distributor; or (b) Transaction or transfer of a co–licensed product between co–licensed partners. (13) “Manufacturer” means a person licensed or approved by the U.S. Food and Drug Administration to engage in the manufacture of prescription drugs or prescription devices, consistent with the definition of “Manufacturer” under the U.S. Food and Drug Administration's regulations and guidelines implementing the Prescription Drug Marketing Act. (14) “Manufacturer's exclusive distributor” means a person who: (a) Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; and (b) Takes title to the manufacturer's prescription drug, but does not have general responsibility to direct the sale or disposition of the manufacturer's prescription drug. (14-1) “NDA” means a New Drug Application number assigned by the FDA for drugs formally proposed to the FDA as a new pharmaceutical for sale and marketing in the U.S. (15) “Normal distribution channel” means a chain of custody for a prescription drug that, directly or by drop shipment, goes: (a) From: (i) A manufacturer of the prescription drug; or (ii) The manufacturer's co-licensed partner, third-party logistics provider, or manufacturer's exclusive distributor; and (b) To: (i) A pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient; (ii) A wholesale distributor to a pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient; (iii) A wholesale distributor to a pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy or other designated person authorized by law to dispense or administer the prescription drug to a patient; (iv) A pharmacy warehouse to the pharmacy warehouse's intracompany pharmacy, or other designated person authorized by law to dispense or administer the prescription drug to a patient; or (v) An authorized distributor of record to another authorized distributor of record solely for distribution to an office-based health care practitioner authorized by law to dispense or administer the prescription drug to a patient. (16) “Pedigree” means a document or electronic file containing information that records each wholesale distribution of a prescription drug. (16-1) “Pharmacy” means a pharmacy that has been issued a: (a) Waiver pharmacy permit in accordance with COMAR 10.34.17; or (b) Full service pharmacy permit. (17) “Prescription device” means any device required by federal law or regulation to be dispensed only by a prescription. (18) Prescription Drug. (a) “Prescription drug” means any drug required by federal law or regulation to be dispensed only by a prescription. (b) “Prescription drug” includes: (i) A biological product; and (ii) Finished dosage forms and bulk drug substances subject to §503(b) of the Federal Food, Drug and Cosmetic Act. (c) “Prescription drug” does not include blood and blood components intended for transfusion or biological products that are also medical devices. (18-1) “Reinstatement” means renewal of a wholesale distributor permit after the permit has expired. (18-2) “Renewal” means renewing a wholesale distributor permit before the date of expiration. (19) Repackage. (a) “Repackage” means to repackage or otherwise change the container, wrapper, or labeling of a prescription drug to further the distribution of the prescription drug. (b) “Repackage” does not include changes to a container, wrapper, or labeling of a prescription drug completed by the pharmacist responsible for dispensing the prescription drug to a patient. (20) “Repackager” means a person who repackages prescription drugs. (21) “Third-party logistics provider” means a person who: (a) Contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer; and (b) Does not take title to the prescription drug, or have general responsibility to direct the prescription drug's sale or disposition. (21-1) “UDI” means a Unique Device Identification number that is created through a globally accepted device identification and coding standard that allows the unambiguous identification of a specific medical device. (21-2) Virtual Manufacturer. (a) “Virtual Manufacturer” means an entity that engages in the manufacture of drug or device products for which it: (i) Owns the NDA or ANDA number, if a prescription drug; (ii) Owns the UDI number, as available, for a prescription device; (iii) Contracts with a contract manufacturing organization for the physical manufacture of the drug or device product; (iv) Is not involved in the physical manufacture of the drug or device product; and (v) At no time takes physical possession of, or stores, the drug or device product. (b) “Virtual Manufacturer” may include entities that are identified as a broker, own-label distributor, sponsor manufacturer, private-label manufacturer, or contract manufacturer. (22) Wholesale Distribution. (a) “Wholesale distribution” means the distribution of prescription drugs or prescription devices to persons other than a consumer or patient. (b) “Wholesale distribution” does not include: (i) Intracompany sales; (ii) The sale, purchase, distribution, trade, or transfer of a prescription drug or an offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons which include transfers of prescription drugs or devices by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage; (iii) The distribution of samples of a prescription drug by a manufacturer's representative; (iv) Prescription drug returns conducted by a hospital, health care entity, or charitable institution in accordance with 21 CFR §203.23, as amended; (v) The sale of minimal quantities of prescription drugs by retail pharmacies to licensed health care practitioners for office use; (vi) The sale, purchase, or trade of a prescription drug, an offer to sell, purchase, or trade a prescription drug, or the dispensing of a prescription drug in accordance with a prescription; (vii) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy to or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets; (viii) The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record, if the manufacturer has stated in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the prescription drug, and the supplying authorized distributor of record states in writing that the prescription drug being supplied had until that time been exclusively in the normal distribution channel; (ix) The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the prescription drug; or (x) The sale or transfer from a pharmacy or pharmacy warehouse of expired, damaged, returned, or recalled prescription drugs to the original wholesale distributor, the original manufacturer, or a third-party returns processor. (23) Wholesale Distributor. (a) “Wholesale distributor” means a person that is engaged in the wholesale distribution of prescription drugs or prescription devices. (b) “Wholesale distributor” includes: (i) A manufacturer; (ii) A repackager; (iii) An own-label distributor; (iv) A private-label distributor; (v) A jobber; (vi) A broker; (vii) A warehouse, including a manufacturer's or distributor's warehouse; (viii) A manufacturer's exclusive distributor, or an authorized distributor of record; (ix) A drug wholesaler or distributor; (x) An independent wholesale drug trader; (xi) A third-party logistics provider; (xii) A pharmacy that conducts wholesale distribution, if the wholesale distribution business accounts for more than 5 percent of the pharmacy's annual sales; and (xiii) A pharmacy warehouse that conducts wholesale distribution. #### Regulation .03-1 Minimum Application Requirements for Virtual Manufacturers. *COMAR 10.34.22.03-1* The information and qualification requirements for obtaining a permit under Regulation .03 of this chapter, beyond that required by federal law, do not apply to a virtual manufacturer that meets the following requirements: A. Provides a list of drug or device products it distributes; B. Provides a list of the NDA or ANDA numbers associated with each drug it distributes; C. Provides a list of the UDI numbers, as available, associated with each device it distributes; D. Provides the name and facility address of the contract manufacturer for each drug or device product it distributes; E. Provides verification of current FDA registration for each contract manufacturing facility listed; F. If the contract manufacturer distributes into this State, provides the wholesale distributor permit number for the contract manufacturer; G. If the contract manufacturer does not distribute into this State, provides name and Maryland’s wholesale distributor permit number for the entity that physically distributes the product into this State; H. Provides a statement affirming that the virtual manufacturer does not contract the manufacture or distribution for drugs or devices other than those for which it owns the NDA, ANDA, or UDI numbers; I. Provides an attestation by the owner of the virtual manufacturer that it does not hold product; J. Provides a copy of existing licensure from the state in which it is located, if applicable; and K. Has valid federal licensure or registration, as verified by the Board. #### Regulation .03 Minimum Application Requirements for Applicants Holding Product. *COMAR 10.34.22.03* A. The Board shall require the following minimum information from a wholesale distributor as part of an application for a permit and as part of a renewal of a permit: (1) The type of business form under which the applicant operates, such as partnership, corporation, or sole proprietorship; (2) The full name or names of the owner and the operator of the wholesale distributor applying for or renewing a permit, including: (a) For an individual, the: (i) Full name of the individual; (ii) Telephone number of the individual; (iii) Business address of the individual; and (iv) Date of birth of the individual; (b) For a partnership, the: (i) Full name of each partner; (ii) Telephone number of the partnership; (iii) Address of each partner; (iv) Date of birth of each partner; (v) Business address of the partnership; and (vi) Federal employer identification number of the partnership; (c) For a publicly traded corporation, the: (i) Full name and title of each corporate officer and director; (ii) Telephone number of the publicly traded corporation; (iii) Business address of the corporation; (iv) Federal employer identification number of the corporation; (v) Name of parent company or companies if applicable; (vi) Corporate names; (vii) Name of the state of incorporation; and (viii) Name and address of the resident agent of the corporation; (d) For a nonpublicly traded corporation, the: (i) Full name and title of each corporate officer and director; (ii) The telephone number of the nonpublicly traded corporation; (iii) Business address of the corporation; (iv) Federal employer identification number of the corporation; (v) Name of parent company or companies if applicable; (vi) Corporate names; (vii) Full name and business address of shareholders of more than 10 percent of the corporation, including over-the-counter stock, unless the stock is traded on a major stock exchange; (viii) Name of the state of incorporation; and (ix) Name and address of the resident agent of the corporation; (e) For a sole proprietorship, the: (i) Full name of the sole proprietor; (ii) The telephone number of the sole proprietor; (iii) Full name of the business entity; (iv) Business address; and (v) Date of birth of the sole proprietor; (f) For a limited liability company, the: (i) Full name and business address of the limited liability company; (ii) Telephone number of the limited liability company; (iii) Full name of each member; (iv) Full name of each manager; (v) Federal employer identification number of the limited liability company; (vi) Name of the state in which the limited liability company was organized; and (vii) Name and address of the resident agent of the company; (3) Addresses, telephone numbers, and the names of contact persons for the facility used by the applicant for the storage, handling, and distribution of prescription drugs; (4) All trade or business names used by the permit holder which may not be identical to the name used by another unrelated applicant in the State; (5) A list of federal and state licenses, registrations, or permits, including the license, registration, or permit numbers issued to the wholesale distributor by federal authority or another state that authorizes the wholesale distributor to purchase, possess, and distribute prescription drugs or devices; (6) A list of disciplinary actions by federal or state agencies against the wholesale distributor as well as any such actions against principals, owners, directors, or officers; (7) For the designated representative and the immediate supervisor of the designated representative at the applicant's place of business the following information: (a) Names; (b) Places of residence for the past 7 years; (c) Dates and places of birth; (d) The name and address of each business where the individual was employed during the past 7 years, and the individual's job title or office held at each business; (e) A statement of whether, during the past 7 years, the individual has been the subject of any proceeding for the revocation of any professional or business license or any criminal violation and, if so, the nature and disposition of the proceeding; (f) A statement of whether, during the past 7 years, the individual has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning the event; (g) A description of any involvement, including any investments other than the ownership of stock in a publicly traded company or mutual fund, by the individual during the past 7 years, with any business that manufactures, administers, prescribes, distributes, or stores prescription drugs, and any lawsuits in which the business was named as a party; (h) A description of any misdemeanor or felony offense of which the individual, as an adult, was found guilty, regardless of whether adjudication of the guilt was withheld or whether the individual pled guilty or nolo contendere; (i) If the individual indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal, within 15 days after the disposition of the appeal, a copy of the final written order of disposition; and (j) A photograph of the individual taken in the previous 180 days; (8) A full description of the facility and warehouse including: (a) Square footage; (b) Security and alarm system descriptions; (c) Terms of lease or ownership; (d) Address; and (e) Description of temperature and humidity controls; (9) Written evidence that the wholesale distributor has obtained general and product liability insurance; (10) A description of the wholesale distributor's import and export activities; and (11) Other relevant information that the Board may require. B. Criminal Background Check Requirements for an Applicant Located in this State. The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to the Central Repository and the Federal Bureau of Investigation: (1) Electronically or digitally captured fingerprints at approved electronic fingerprint locations approved by the Director of the Central Repository; (2) The fee authorized under the Criminal Procedure Article, §10-221(b)(7), Annotated Code of Maryland, for access to State criminal history records; and (3) The processing fee required by the Federal Bureau of Investigation for a national criminal history records check. B-1. Criminal Background Check Requirements for an Applicant Located Outside this State. (1) The Board shall require the designated representative and the immediate supervisor of the designated representative at the applicant's place of business as part of the application for a permit to submit to a criminal history records check by the applicant’s state of residence, in accordance with the laws of the applicant’s state of residence. (2) The criminal history records check shall consist of: (a) A state criminal history records check for the applicant’s state of residence; and (b) A national criminal history records check. (3) The designated representative and the immediate supervisor of the designated representative of an applicant shall request the appropriate entity in the applicant’s state of residence to forward the results of the criminal history records check to the Board and the applicant. (4) If the appropriate entity in the applicant’s state of residence is unable to forward the results of the criminal history records check, then the designated representative and the immediate supervisor of the designated representative of an applicant shall ensure that the results of the criminal history records check are forwarded to the Board in a manner approved by the Board. C. The information required under §A of this regulation shall be provided under oath. D. The Board may not issue an initial or renewal wholesale distributor permit to an applicant unless the Board or its designee: (1) If the applicant holds prescription drugs or devices, conducts a physical inspection of the applicant's place of business, including any facility of the applicant; (2) Finds that the place of business and facility, if any, meets the Board's requirements; (3) Determines that the designated representative of the applicant meets the following qualifications: (a) Is 21 years old or older; (b) Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs; (c) Is employed by the applicant full time in a managerial level position; (d) Is actively involved in, and aware of, the daily operation of the wholesale distributor; (e) Is physically present, except for an authorized absence such as sick leave or vacation leave, at the facility of the applicant during regular business hours; (f) Is serving as a designated representative for only one applicant at a time, or for two or more wholesale distributors who are located in the same facility and are members of an affiliated group, as defined in §1504 of the Internal Revenue Code; (g) Does not have any convictions for a violation of any federal, State, or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances; and (h) Does not have any convictions for a felony under federal, State, or local laws; and (4) Determines that the immediate supervisor of the designated representative of the applicant meets the following qualifications: (a) Is 21 years old or older; (b) Has been employed full time for at least 3 years in a pharmacy or with a wholesale distributor in a capacity related to the dispensing and distribution of, and record keeping relating to, prescription drugs; (c) Is employed by the applicant full time in a managerial level position; (d) Is actively involved in, and aware of, the daily operation of the wholesale distributor; (e) Does not have any convictions for a violation of any federal, state, or local laws relating to wholesale or retail prescription drug distribution, or distribution of controlled substances; and (f) Does not have any convictions for a felony under federal, state, or local laws. E. Surety Bond. (1) An applicant for a wholesale distributor permit shall submit a surety bond or other equivalent means of security acceptable to the State such as an irrevocable letter of credit, or a deposit in a trust account or financial institution, payable to the State Board of Pharmacy to be deposited into an account established by the State under Health Occupations Article, §12-6C-05(f)(7), Annotated Code of Maryland. (2) The surety bond, or other security, shall be in the amount of: (a) $100,000, if the annual gross receipts of the applicant for the previous tax year are $10,000,000 or more; or (b) $50,000, if the annual gross receipts of the applicant for the previous tax year are less than $10,000,000. (3) An applicant shall submit the following documentation to verify the applicant's annual gross receipts in the State are less than $10,000,000 for the previous tax year: (a) A federal tax return; or (b) An annual sales report specifying the sales of prescription drugs and devices in the State audited by a certified public accountant. (4) A surety bond is not required for a pharmacy warehouse that is not engaged in wholesale distribution. (5) An applicant shall obtain a surety bond for each facility. (6) A single surety bond may cover all facilities operated by the applicant within this State. F. If a wholesale distributor distributes prescription drugs or prescription devices from more than one facility, the wholesale distributor shall obtain a permit for each facility. G. The Board shall notify the applicant of the Board's acceptance or rejection of the application within 30 days after the date the Board receives a completed application, including the results of all required criminal history records checks. H. The applicant shall pay to the Board an application fee set forth in COMAR 10.34.09.02. I. The wholesale distributor shall provide changes in information provided pursuant to Regulation .03 of this chapter to the Board within 30 days of the effective date of the change. J. Information and qualification requirements for obtaining a permit under this regulation, beyond that required by federal law, does not apply to a manufacturer who distributes its own prescription: (1) Drugs approved by the U.S. Food and Drug Administration; or (2) Devices that are approved or authorized by the U.S. Food and Drug Administration. #### Regulation .04 Personnel. *COMAR 10.34.22.04* A. The permit holder shall affirm in the initial application and subsequent renewal applications that personnel employed in wholesale distribution have appropriate education and experience to assume responsibilities related to compliance with State licensing requirements. B. Registered Agent. (1) Each licensed wholesale distributor located outside of this State that wholesale distributes prescription drugs or devices in this State shall designate a registered agent in this State for service of process. (2) If any wholesale distributor is not licensed in this State, service on the Director of the State Department of Assessments and Taxation only shall be sufficient service. C. Requirements and Responsibilities of the Designated Representative. (1) The designated representative shall be aware of, and knowledgeable about, all policies and procedures pertaining to the operations of the wholesale distributor, including applicable State and federal laws. (2) The designated representative shall have documented training sufficient to ensure that operations of the wholesale distributor are in compliance with applicable State and federal laws and are provided by qualified in-house specialists, outside counsel, or consulting specialists with capabilities to help ensure compliance with all applicable State and federal laws and regulations. (3) The designated representative shall maintain current working knowledge of the requirements for wholesale distributor and assure ongoing training for personnel to ensure compliance. (4) The designated representative shall be responsible for all record keeping requirements and make all records available for inspection. #### Regulation .05 Violations and Penalties. *COMAR 10.34.22.05* A. After a hearing held under Health Occupations Article, §12-601, Annotated Code of Maryland, the Board may deny, suspend, revoke, or place on probation a permit holder, reprimand a permit holder, or impose a fine if the permit holder: (1) Is convicted of, or pleads guilty or nolo contendere to, violations of federal, State, or local drug or device laws or regulations; (2) Is convicted of, or pleads guilty or nolo contendere to, a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; (3) Commits any of the following acts: (a) Obtains or attempts to obtain a permit by: (i) Providing false information to the Board; or (ii) Other fraudulent or deceptive means; (b) Fails to: (i) Establish or maintain inventories, records, or written policies and procedures as required by Regulation .07 of this chapter; (ii) Register with the Maryland Division of Drug Control, and with the U.S. Drug Enforcement Agency, as required by Regulation .07D of this chapter; or (iii) Permit the Board, the Maryland Division of Drug Control, the U.S. Drug Enforcement Agency, or other authorized federal, State, or local law enforcement officials showing proper identification, to enter, inspect, copy records, or audit as required by Regulation .07D of this chapter; (c) Willfully makes or maintains false inventories or records; (d) Violates a provision of, or regulation promulgated under, Health Occupations Article, Title 12, Annotated Code of Maryland; (e) Manufactures, repackages, sells, delivers, or holds or offers for sale any prescription drug or device that is adulterated, misbranded, counterfeit, suspected of being counterfeit, or has otherwise been rendered unfit for distribution or wholesale distribution; (f) Adulterates, misbrands, or counterfeits prescription drugs or devices; (g) Receives prescription drugs or devices that are adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected of being counterfeit, or delivers or proffers delivery of such prescription drug or device for pay or otherwise; (h) Alters, mutilates, destroys, obliterates, or removes the whole or any part of the product labeling of a prescription drug or device, or commits any other act with respect to a prescription drug or device that results in the prescription drug or device being misbranded; (i) Forges, counterfeits, simulates, or falsely represents prescription drugs or devices without the authority of the manufacturer, or uses any mark, stamp, tag, label, or other identification device without the authorization of the manufacturer; (j) Purchases or receives a prescription drug or device from a person who is not licensed to wholesale distribute prescription drugs or devices to that purchaser or recipient; (k) Sells or transfers a prescription drug or device to a person who is not legally authorized to receive a prescription drug or device; (l) Provides the Board, its representatives, or federal or State officials with false or fraudulent records, or makes false or fraudulent statements regarding any matter within the provisions of these regulations; (m) Wholesale distributes prescription drugs or devices that were: (i) Purchased by a public or private hospital, or other health care entity; (ii) Donated or supplied at a reduced price to a charitable organization; (iii) Stolen or obtained by fraud or deceit; or (iv) Donated to a drop-off site or repository under the Prescription Drug Repository Program set forth in Health-General Article, Title 15, Subtitle 6, Annotated Code of Maryland; (n) Fails to obtain a license, or operates without a valid license when a license is required; (o) Obtains, or attempts to obtain, a prescription drug or device by fraud, deceit, misrepresentation, or engages in misrepresentation or fraud in the distribution or wholesale distribution of a prescription drug or device; (p) Distributes a prescription drug or device to a consumer or patient; (q) Fails to obtain, authenticate, or pass on a pedigree when required under these regulations; (r) Receives a prescription drug pursuant to a wholesale distribution without first receiving a pedigree, when required, that was attested to as accurate and complete by the wholesale distributor; (s) Distributes or wholesale distributes a prescription drug or device that was previously dispensed by a pharmacy or distributed by a practitioner; (t) Fails to report prohibited acts as listed in these regulations; (u) Fails to exercise due diligence as provided in Regulation .08 of this chapter; (v) Otherwise conducts the wholesale distribution of prescription drugs or devices in a manner not in accordance with the law; (w) Accepts payment or credit for the sale of prescription drugs in violation of Health Occupations Article, §12-6C-09(d), Annotated Code of Maryland; or (x) If the requirements of Health Occupations Article, §12-6C-09(a), Annotated Code of Maryland, are applicable and are not met, the purchasing or otherwise receiving a prescription drug from a pharmacy; or (4) Is disciplined by a licensing or disciplinary authority of any state or country, or disciplined by a court of any state or country, for an act that would constitute a ground for Board action against a wholesale distributor permit holder under §A or B of this regulation. B. Acts prohibited under this regulation do not include a prescription drug manufacturer, or agent of a prescription drug manufacturer, obtaining or attempting to obtain a prescription drug for the sole purpose of testing the prescription drug for authenticity. #### Regulation .06 Minimum Requirements for the Storage and Handling of Prescription Drugs or Devices. *COMAR 10.34.22.06* A. Facilities. Facilities at which prescription drugs or devices are stored, warehoused, handled, held, offered, marketed, or displayed shall: (1) Be of suitable size and construction to facilitate: (a) Cleaning; (b) Maintenance; and (c) Proper operations; (2) Have storage areas designed to provide adequate: (a) Equipment; (b) Humidity control; (c) Lighting; (d) Sanitation; (e) Security conditions; (f) Space; (g) Temperature; and (h) Ventilation; (3) Have a quarantine area for storage of prescription drugs or devices that are: (a) Adulterated; (b) Damaged; (c) Deteriorated; (d) In immediate or sealed secondary containers that have been opened; (e) Misbranded; or (f) Outdated; (4) Be maintained in a clean and orderly condition; and (5) Be free from infestation by insects, rodents, birds, or vermin. B. Security. A facility: (1) Used for wholesale distribution shall be secure from unauthorized entry as follows: (a) Access from outside the premises shall be: (i) Kept to a minimum; and (ii) Well controlled; (b) The outside perimeter of the premises shall be well lit; and (c) Entry into areas where prescription drugs or devices are held shall be limited to authorized personnel; (2) Shall be equipped with: (a) An alarm system to detect entry after hours; (b) A security system that provides protection against theft and diversion; (c) Appropriate software to facilitate the identification of evidence of tampering with computers or electronic records; (d) An inventory management and control system that protects against, detects, and documents any instances of theft, diversion, or counterfeiting; (e) A security system to protect the integrity and confidentiality of data and documents; (f) Video monitoring of all entrances and exits, or alternate acceptable security; and (g) A means to make the data and documentation required under this section readily available to the Board, an agent of the Board, or federal and other State law enforcement officials. C. Storage. (1) A wholesale distributor shall store a prescription drug or device at appropriate temperatures and under appropriate conditions in accordance with requirements: (a) If any, of the labeling of the drug or device; or (b) Set forth in the current edition of an official compendium, such as the United States Pharmacopeia/National Formulary (USP/NF), under 21 CFR §205.50(c), as amended. (2) If no storage requirements are established for a prescription drug or device, the drug or device shall be held at a controlled room temperature, as defined in an official compendium as set forth in §C(1)(b) of this regulation to help assure that its identity, strength, quality, and purity are not adversely affected. (3) A wholesale distributor shall use appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and logs to document proper storage of prescription drugs or devices. (4) A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for stored prescription drugs or devices. D. Examination of Materials. (1) Upon receipt, a wholesale distributor shall visually examine each outside shipping container for identity and to prevent the acceptance of: (a) Contaminated prescription drugs or devices; or (b) Prescription drugs or devices that are otherwise unfit for distribution. (2) The examination required under §D(1) of this regulation shall be adequate to reveal container damage that would suggest possible contamination or other damage to the contents. (3) A wholesale distributor shall carefully inspect each outgoing shipment: (a) For identity of the prescription drug or device product; and (b) To ensure that there is no delivery of a prescription drug or device that has been damaged in storage or held under improper conditions. (4) A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for incoming and outgoing prescription drugs or devices. E. Returned, Damaged, and Outdated Prescription Drugs or Devices. (1) A wholesale distributor shall quarantine and physically separate prescription drugs or devices that are outdated, damaged, deteriorated, misbranded, or adulterated from other prescription drugs or devices until the quarantined and separated drugs or devices are destroyed or returned to their supplier for proper disposal. (2) The wholesale distributor shall identify, mark, quarantine, and physically separate from other prescription drugs or devices those prescription drugs or devices whose immediate or sealed outer or sealed secondary containers have been opened or used, until the drugs or devices are either destroyed or returned to their supplier for proper disposal. (3) Prescription Drugs. (a) If the conditions under which a prescription drug has been returned cast doubt on the prescription drug's safety, identity, strength, quality, or purity, then the wholesale distributor shall destroy or return the prescription drug to the supplier, unless examination, testing, or other investigation proves that the prescription drug meets appropriate standards of safety, identity, strength, quality, and purity. (b) In determining whether the conditions under which a prescription drug has been returned cast doubt on the prescription drug's safety, identity, strength, quality, or purity, the wholesale distributor shall consider, at a minimum, the: (i) Conditions under which the prescription drug has been held, stored, or shipped before or during its return; and (ii) Condition of the prescription drug and its container, carton, or labeling, as a result of storage or shipping. (4) Prescription Devices. (a) If the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, then the wholesale distributor shall destroy or return the prescription device to the supplier, unless examination, testing, or other investigation proves that the prescription device meets appropriate standards of safety, identity, strength, and quality. (b) In determining whether the conditions under which a prescription device has been returned cast doubt on the prescription device's safety, identity, or quality, the wholesale distributor shall consider, among other things, the: (i) Conditions under which the prescription device has been held, stored, or shipped before or during its return; and (ii) Condition of the prescription device and its container, carton, or labeling, as a result of storage or shipping. (5) A wholesale distributor shall follow the record-keeping requirements in Regulation .07 of this chapter for outdated, damaged, deteriorated, misbranded, or adulterated prescription drugs or devices. #### Regulation .07 Minimum Requirements for Maintenance of Prescription Drug or Device Distribution Records. *COMAR 10.34.22.07* A. Record Keeping. (1) A wholesale distributor shall establish and maintain inventories and records of transactions regarding the receipt and distribution or other disposition of prescription drugs or devices. (2) The records required under §A(1) of this regulation shall include the following information: (a) The source of the prescription drugs or devices, including the: (i) Name and principal address of the seller or transferor; and (ii) Address of the location from which the prescription drugs or devices were shipped; (b) The identity and quantity of the prescription drugs or devices received and distributed or disposed of; (c) The dates of receipt and distribution or other disposition of the prescription drugs or devices; and (d) The pedigrees, if required by Health Occupations Article, §12-6C-10, Annotated Code of Maryland, for prescription drugs that are wholesale distributed outside the normal distribution channel. (3) The wholesale distributor shall make available inventories and records for inspection and copying by authorized federal, State, or local law enforcement agency officials for a period of 3 years after their date of creation. (4) The wholesale distributor shall keep the records described in this regulation readily available for inspection by authorized federal, State, or local law enforcement agency officials during the retention period, either: (a) At the inspection site; or (b) So as to be immediately retrievable by computer or other electronic means. (5) Within 5 working days of a request by an authorized official of a federal, State, or local law enforcement agency, the wholesale distributor shall make available for inspection records kept at a central location apart from the inspection site and not electronically retrievable. (6) Facilities shall establish and maintain procedures for reporting counterfeit and contraband or suspected counterfeit and contraband drugs or devices or counterfeiting and contraband or suspected counterfeiting and contraband activities to the Board and the FDA. (7) Wholesale distributors shall maintain a system for the mandatory reporting of significant inventory losses of prescription drugs and devices where it is known or suspected that diversion is occurring to the Board, the FDA, and, where applicable, to the DEA. (8) Wholesale distributors shall consider the following factors when determining if there has been a significant inventory loss: (a) The schedule of the missing items; (b) The abuse or misuse potential of the missing items; (c) The abuse or misuse potential in the wholesale distributor's area of the missing substance; (d) The quantity missing in relation to the total quantity purchased (one tablet vs. one bottle or container); (e) Whether this is the first time a potentially significant inventory loss has occurred; (f) Whether this loss was reported to local law enforcement authorities; and (g) Whether there is a significant resale value of the missing items. B. Written Policies and Procedures. (1) A wholesale distributor shall establish, maintain, and adhere to written policies and procedures which shall be followed for: (a) The receipt, security, storage, inventory, and distribution of prescription drugs or devices; (b) Identifying, recording, and reporting losses or thefts; and (c) Correcting errors and inaccuracies in inventories. (2) A wholesale distributor shall include in the written policies and procedures the following: (a) A procedure by which the oldest approved and unexpired stock of a prescription drug or device is distributed first; (b) Procedures to be followed for adequate handling of a recall and withdrawal of a prescription drug or device due to: (i) An action initiated at the request of the United States Food and Drug Administration or other federal, State, or local law enforcement or other government agency, including the Maryland Division of Drug Control; (ii) A voluntary action by the manufacturer to remove a defective or potentially defective drug or device from the market; and (iii) An action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design; (c) A procedure to ensure that the wholesale distributor is prepared for, protected against, and is able to handle a crisis that affects security or operation of a facility if any of the following situations occurs: (i) Strike; (ii) Fire; (iii) Flood; (iv) Catastrophic health emergency as defined in Public Safety Article, §14-3A-01, Annotated Code of Maryland; (v) Terrorist activities; (vi) Other natural disaster; or (vii) Other situations of local, State, or national emergency; (d) A procedure to ensure that an outdated prescription drug or device is segregated from other drugs or devices and either returned to the manufacturer or destroyed; (e) A procedure for the disposing and destruction of containers, labels, and packaging to ensure that the containers, labels, and packaging cannot be used in counterfeiting activities, including all necessary documentation, maintained for a minimum of 3 years, and the appropriate witnessing of the destruction of any labels, packaging, immediate containers, or containers in accordance with applicable federal and State requirements; and (f) A procedure for identifying, segregating, investigating, and reporting prescription drug inventory discrepancies involving counterfeit, suspect of being counterfeit, contraband, or suspect of being contraband, in the inventory and reporting of such discrepancies within 5 business days to the Board and appropriate federal or State agency upon discovery of such discrepancies. (3) If deviation is appropriate, a wholesale distributor may temporarily deviate from the requirement in §B(2)(a) of this regulation that the oldest approved and unexpired stock be distributed first. (4) The wholesale distributor shall maintain documentation of the disposition of outdated prescription drugs or devices for 2 years after the disposition of the outdated prescription drugs or devices pursuant to procedures under §B(2)(d) of this regulation. C. Responsible Individuals. A wholesale distributor shall establish and maintain a list of officers, directors, managers, the designated representative, and others in charge of wholesale distribution, storage, and handling, including: (1) A description of their duties; and (2) A summary of their qualifications. D. Compliance with Federal, State, and Local Law. A wholesale distributor shall: (1) Operate in compliance with applicable federal, State, and local laws and regulations; (2) Permit at reasonable times and in a reasonable manner, the Board, the State Division of Drug Control, and any other authorized federal, State, and local law enforcement officials showing proper identification to: (a) Enter and inspect the distributor's premises and delivery vehicles; and (b) Audit and copy the distributor's records and written operating procedures; and (3) If dealing in controlled substances: (a) Register with the: (i) Maryland Division of Drug Control; and (ii) United States Drug Enforcement Administration; and (b) Comply with all applicable federal, State, and local regulations. E. Salvaging and Reprocessing. (1) A wholesale distributor is subject to the provisions of applicable federal, State, or local laws or regulations that relate to prescription drug product salvaging or reprocessing, including 21 CFR Parts 207, 210, and 211, as amended. (2) A wholesale distributor is subject to the provisions of any applicable federal, State, or local laws or regulations that relate to prescription device product salvaging or reprocessing. #### Regulation .08 Due Diligence. *COMAR 10.34.22.08* Wholesale distributors having transactions with persons not licensed by the Board or not certified by a third party recognized by the Board shall have in place policies and procedures to perform due diligence on transactions that take place that include: A. Verification of alternate licensure; B. Verification of identity; and C. Verification of recent inspections by a state or third party entity recognized by the Board. #### Regulation .09 Reinstatement. *COMAR 10.34.22.09* A. The wholesale distributor permit shall expire on the last day of its term. B. The Board may not reinstate the wholesale distributor permit unless the applicant pays a reinstatement fee set by the Board. #### Regulation .10 Required Information and Procedures for Ceasing to Operate. *COMAR 10.34.22.10* A. If a wholesale distributor is located in another state, a wholesale distributor anticipating ceasing to operate in Maryland shall return the permit to the Board within 10 days of ceasing to operate in Maryland. B. Procedures for Wholesale Distributors Located in this State for Ceasing to Operate. (1) Notification. (a) At least 30 days before a wholesale distributor’s anticipated date of ceasing to operate, the wholesale distributor shall notify the Board in writing, by certified mail, return receipt requested, or hand delivered to the Board’s office, of the day on which the wholesale distributor will cease to operate. (b) A wholesale distributor shall: (i) Notify drug and device suppliers that supply prescription drugs and devices to the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate; (ii) Notify manufacturers, wholesale distributors, licensed pharmacies and authorized prescribers that receive prescription drugs and devices from the wholesale distributor, at least 30 days in advance of ceasing to operate, of the date that the wholesale distributor will cease to operate; and (iii) Comply with applicable federal regulations. (2) The wholesale distributor shall submit to and pass a closing inspection conducted by the Board. (3) With the exception of controlled dangerous substances, the wholesale distributor shall dispose of prescription drugs or devices in stock by one or more of the following means: (a) Returning the prescription drugs or devices to a distributor or manufacturer; (b) Transferring the prescription drugs or devices to another wholesale distributor, licensed pharmacy, authorized prescriber, or other person or entity approved by the Board; or (c) Destroying in accordance with this regulation. (4) Disposition of Controlled Dangerous Substances. The wholesale distributor shall comply with the procedures set forth in this regulation in addition to those set forth in COMAR 10.19.03.10 governing the transfer, return or disposal of controlled dangerous substances. (5) At the closing inspection, the wholesale distributor shall provide to the Board the following: (a) The exact date on which the wholesale distributor ceased to operate; (b) A copy of the inventory of prescription drugs or devices disposed of, transferred, or returned. (c) The names, addresses, telephone numbers, and Drug Enforcement Administration registration numbers, if applicable, of the persons or business entities to whom prescription drugs or devices in stock were returned or transferred under this regulation; (d) The wholesale distributor permit; (e) If prescription drugs or devices are destroyed pursuant to this regulation, a letter, signed under oath by the wholesale distributor, stating the: (i) Date, place and manner in which the prescription drugs or devices were destroyed; (ii) Names, addresses, and telephone numbers of the persons responsible for destroying the prescription drugs or devices; and (iii) Name, dosage unit, and quantity of each type of prescription drug or device destroyed; and (f) If any pedigrees or other documents are transferred, a letter, signed under oath by the wholesale distributor, stating: (i) The date, time, place to which and manner in which the pedigrees or other documents were transferred; and (ii) The names, addresses, and telephone numbers of the persons responsible for transferring the pedigrees or other documents. (6) At the closing inspection, the wholesale distributor shall provide to the Division of Drug Control the following pertaining to controlled dangerous substances: (a) The exact date on which the wholesale distributor ceased to operate; (b) A copy of the closing inventory of controlled dangerous substances required by the Drug Enforcement Administration. (c) The names, addresses, telephone numbers, Drug Enforcement Administration registration numbers, Division of Drug Control registration numbers, and Board permit numbers, if applicable, of the persons or business entities to whom controlled dangerous substances in stock were returned or transferred under this regulation; and (d) The Maryland Department of Health Controlled Dangerous Substance Registration for cancellation. #### Regulation .11 Relocation. *COMAR 10.34.22.11* A. At least 30 days before relocation, a permit holder shall submit an application to the Board. B. If relocation is due to a catastrophic event or State of Emergency, the relocation applicant shall: (1) Notify the Board within 48 hours; and (2) Submit an application to the Board within 30 days. C. A relocation applicant: (1) If the applicant holds products, shall comply with Regulation .07 of this chapter; (2) Shall submit a surety bond or other equivalent means of security acceptable to the State specific to the permit holder’s relocation, in accordance with Regulation .03 if this chapter; and (3) Shall indicate on the application changes in product or personnel from the original application to the Board. D. A new or different designated representative or immediate supervisor of a designated representative functioning at the relocated facility shall be required to undergo a criminal history records check as set forth in Regulation .03 of this chapter. E. As part of the application process, a relocation applicant located in this State shall submit to and pass an opening inspection conducted by the Board, which shall include: (1) Documentation of the permit holder’s notification to suppliers of prescription drugs and devices of the permit holder’s relocation; and (2) Documentation from the permit holder evidencing the appropriate transfer, return, or disposal of any prescription drugs or devices not transferred to the facility’s relocation. F. A relocation applicant located in another state shall provide to the Board: (1) Evidence of approval of the permit holder’s relocation from the accreditation organization that accredited the permit holder’s original location; or (2) If the relocation applicant is not required to be accredited by an accreditation organization in accordance with Maryland law, inspection reports from the state in which the relocation applicant is located pertaining to the permit holder’s relocation. ### Chapter 23 — Pharmaceutical Services to Patients in Comprehensive Care Facilities **Authority:** Health Occupations Article, §§12-205, 12-301, 12-401, 12-403, 12-501, 12-503, 12-504, 12-505, 12-506, and 12-6B-01, Annotated Code of Maryland **Administrative History:** Effective date: October 7, 1996 (23:20 Md. R. 1424) **Administrative History:** Chapter revised effective June 1, 2011 (38:11 Md. R. 671) **Administrative History:** Regulation .03E amended effective September 16, 2013 (40:18 Md. R. 1479) **Administrative History:** Regulation .07D, E amended effective April 2, 2012 (39:6 Md. R. 408) **Administrative History:** Regulation .08B amended effective April 2, 2012 (39:6 Md. R. 408) **Administrative History:** Regulation .09G amended effective September 16, 2013 (40:18 Md. R. 1479) #### Regulation .01 Scope. *COMAR 10.34.23.01* This chapter applies to pharmacies and licensed pharmacists serving comprehensive care facilities as defined in Regulation .02 of this chapter, except for pharmacies providing only emergency services for these facilities. #### Regulation .02 Definitions. *COMAR 10.34.23.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Chart order” means a lawful order entered on the chart or a medical record of a patient of a comprehensive care facility by an authorized prescriber or the authorized prescriber’s designated agent for a drug or device. (2) Comprehensive Care Facility. (a) “Comprehensive care facility” means a facility which admits patients suffering from disease, disabilities, or advanced age, requiring medical service and nursing service rendered by or under the supervision of a registered nurse. (b) “Comprehensive care facility” does not mean an establishment which provides only: (i) Acute care; or (ii) Assisted living care. (3) “Emergency drug kit” means a container or electronic storage system containing medications which: (a) May be required for the emergency need of a patient; and (b) Are not available from an authorized source in a timely manner. (4) “Interim box” means a container or an electronic system holding minimal quantities of medications: (a) Agreed upon by the comprehensive care facility’s pharmaceutical services committee, as defined in COMAR 10.07.02.15; and (b) Intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply. (5) “Licensed pharmacist” means a pharmacist who is licensed by the Board to practice pharmacy. (6) “Packaging” means the process by which a medication is: (a) Removed from a: (i) Non-patient specific manufacturer’s original container; or (ii) Patient specific container directly received from another pharmacy licensed in Maryland or operated by the government of the United States provided that the manufacturer’s name is present on the container; and (b) Placed into a new container by a licensed pharmacist or registered pharmacy technician under the supervision of a pharmacist. (7) “Pharmaceutical services” means the care within practice standards, laws, regulations, and guidelines which is afforded by a licensed pharmacist to the patients of a comprehensive care facility. (8) “Pharmacy” means a holder of a pharmacy permit issued by the Board, located either on the premises of or outside the comprehensive care facility and which provides pharmaceutical services to patients in a comprehensive care facility. (9) “Pharmacy area” means that portion of the licensed pharmacy where medication and other products requiring a prescription by federal or State law are stored and where the prescriptions are compounded or prepared. (10) “Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts. (11) “Verbal order” means a directive that is orally communicated to a licensed pharmacist to accept a prescription order by a person who is authorized to communicate a prescription. (12) “Written order” means a directive that is directly written by an authorized prescriber or a transcription of an order from an authorized prescriber by a person authorized to transcribe an order. #### Regulation .03 Policies and Procedures. *COMAR 10.34.23.03* The permit holder shall establish and operate under a policies and procedures manual which: A. Complies with this chapter; B. Defines the scope and method of pharmacy services provided to the patients of the comprehensive care facility; C. Determines when personnel may have access to the pharmacy area; D. Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle; E. Includes: (1) Labeling requirements and distribution methods for medication provided in a single container, slot, blister package, or other method of delivering an entire single dosing unit; and (2) The conditions in which an interim box may be replenished or prepared, delivered, and stored by the comprehensive care facility in accordance with Regulation .09 of this chapter; F. Is provided to: (1) The personnel of the pharmacy; (2) The comprehensive care facility; and (3) Upon request, an agent of the Board; and G. Is in a form that is: (1) Written or electronic; and (2) Readily retrievable. #### Regulation .04 Personnel. *COMAR 10.34.23.04* A. Director of Pharmacy. The permit holder shall appoint a licensed pharmacist as director of pharmacy who is: (1) Licensed to engage in the practice of pharmacy in Maryland; (2) Knowledgeable in, and thoroughly familiar with, the specialized functions of comprehensive care facility pharmaceutical services; (3) Responsible for and in full and actual charge of the pharmacy and its personnel; (4) Responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title; (5) Responsible for reviewing the policies and procedures manual of the pharmacy annually and revising it as necessary; (6) On site full time; and (7) Responsible for only one comprehensive care pharmacy. B. Staff. (1) The permit holder: (a) May employ registered pharmacy technicians as required to provide pharmaceutical services to the patients of the comprehensive care facilities; and (b) Shall provide policies and procedures that specify the duties that may be performed by registered pharmacy technicians under the supervision of a licensed pharmacist and the duties that may be performed only by a licensed pharmacist. (2) The permit holder may employ unlicensed personnel to provide operational support as defined in COMAR 10.34.21.02B. #### Regulation .05 Physical Requirements. *COMAR 10.34.23.05* A. Storage. The director of pharmacy or designee shall ensure that medications and supplies within the pharmacy are properly stored according to the manufacturer’s specifications and State and federal laws and regulations with respect to: (1) Sanitation; (2) Temperature; (3) Light; (4) Ventilation; (5) Moisture control; (6) Segregation; and (7) Security. B. Equipment and Materials. (1) The director of pharmacy or designee shall ensure that the pharmacy contains appropriate: (a) Equipment; (b) Supplies; and (c) Physical facilities for proper compounding, preparation, and dispensing of medications as outlined in COMAR 10.34.19. (2) The director of pharmacy or designee shall ensure that the pharmacy contains appropriate reference materials to enable personnel to prepare and dispense medications properly as outlined in COMAR 10.34.07. C. Security. (1) The director of pharmacy or designee shall ensure that no individual enters the pharmacy area unless a licensed pharmacist is on duty. (2) The permit holder and the director of pharmacy or designee shall ensure compliance with COMAR 10.34.05. #### Regulation .06 Medication and Device Distribution and Pharmaceutical Services. *COMAR 10.34.23.06* A. The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder. B. The director of pharmacy or designee shall work in cooperation with the professional staff of the comprehensive care facility in: (1) Meeting the responsibilities set forth in §C of this regulation; and (2) Ordering, storing, and accounting for pharmaceutical materials. C. The director of pharmacy or designee shall be responsible for, at a minimum: (1) The preparation of medications compounded in the pharmacy as applicable; (2) The proper preparation, storage, and distribution of compounded sterile preparations according to COMAR 10.34.19 to the extent that the functions are performed at the pharmacy; (3) The packaging and labeling of medications; (4) Records of transactions of the pharmacy as may be required by applicable law and as may be necessary to maintain accurate control over and accountability for pharmaceuticals, including patient medication profiles; (5) Participation in those aspects of the comprehensive care facility's quality assurance improvement program which relate to pharmaceutical care and effectiveness; and (6) Implementation of the policies and decisions of the appropriate committee or committees of the comprehensive care facility related to these regulations and to other regulations of the facility. #### Regulation .07 Medication Packaging. *COMAR 10.34.23.07* A. A licensed pharmacist shall verify the: (1) Selection of medication to be packaged; and (2) Completed packaging of medication performed by registered pharmacy technicians for the following: (a) Accuracy; (b) Completeness; (c) Appropriateness; and (d) Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging. B. The licensed pharmacist shall ensure that labeling of the medication container includes the: (1) Brand or generic name of the medication; (2) Strength of the medication, if appropriate; (3) Name of the pharmacy; (4) Expiration date of the medication. C. Unless the licensed pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of: (1) 12 months from the date of packaging; (2) The manufacturer's or distributor's listed expiration date; or (3) The maximum time period allowed for the specific packaging used for the medication. D. Packaged from the Manufacturer’s Original Container. The pharmacy may use a lot number and expiration date assigned by the pharmacy instead of the distributor or manufacturer information in a master log if kept with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the: (1) Name of the drug; (2) Strength; (3) Manufacturer; (4) Lot number assigned by the pharmacy; (5) Lot number assigned by the distributor or manufacturer; (6) Quantity packaged; (7) Expiration date as defined in §C of this regulation; (8) Manufacturer's expiration date; (9) Date of packaging; (10) Name of pharmacy technician packaging; and (11) Name and initials of verifying licensed pharmacist. E. Packaged from Another Pharmacy. The licensed pharmacist may package patient specific medication received from another pharmacy licensed in Maryland or operated by the government of the United States provided that: (1) The licensed pharmacist determines that the medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the time it was dispensed by the original pharmacy and received by the packaging pharmacy; (2) The licensed pharmacist packages and dispenses all at one time the entire quantity of the prescription medications received from another pharmacy for packaging; (3) The manufacturer’s name is present on the container received from the other pharmacy; and (4) The licensed pharmacist maintains a master log that includes the following information: (a) Name of the drug; (b) Lot number assigned by the packaging pharmacy; (c) Strength; (d) Manufacturer; (e) Name, address, and telephone number of the original dispensing pharmacy; (f) Prescription number for the original dispensing pharmacy; (g) Quantity packaged; (h) Expiration date as assigned by the original dispensing pharmacy; (i) Date of packaging; (j) Name of pharmacy technician packaging; (k) Name and initials of verifying licensed pharmacist; and (l) Name of the patient. #### Regulation .08 Labeling of Patient Medications. *COMAR 10.34.23.08* A. The director of pharmacy or designee shall ensure that medications dispensed by the pharmacy and intended for use within the comprehensive care facility are dispensed in appropriate containers and are labeled with the: (1) Name and address of the pharmacy; (2) Date of dispensing; (3) Prescription number assigned by the pharmacy; (4) Name of the patient; (5) Name, quantity, and strength of the drug; (6) Name of the prescriber; (7) Expiration date of the drug; (8) Required precautionary information regarding controlled substances; and (9) Further cautionary information as may be required or desirable for proper use of the medication. B. The director of pharmacy or designee shall ensure that medication provided per dosing period in a single container, slot, blister package, any other method of delivering an entire single dosing unit, or as part of a multi-dose dispensing package is labeled with at least the following: (1) Drug name; (2) Drug strength; (3) Name of manufacturer; (4) Name of the patient; (5) Lot number; and (6) Expiration date. C. The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder. D. The director of pharmacy or designee shall work in cooperation with the other professional staff of the comprehensive care facility in meeting the responsibilities set forth in §B of the regulation and in ordering, storing, and accounting for pharmaceutical materials. E. Compounded Sterile Preparations. When compounding sterile preparations a licensed pharmacist or a registered pharmacy technician under the licensed pharmacist’s supervision, shall comply with the compounding and labeling requirements of COMAR 10.34.19. #### Regulation .09 Drug Control and Accountability. *COMAR 10.34.23.09* A. The director of pharmacy or designee shall develop a process for the pharmacy to be notified of medications which have been discontinued. B. Medications may be accepted for return if: (1) The returned medication is properly labeled and properly sealed in the manufacturer’s package or an individually labeled unit dose of a drug or a device; (2) The licensed pharmacist determines that the returned medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy; and (3) The permit holder otherwise complies with COMAR 10.34.10.07. C. Discontinued Medications — Controlled Dangerous Substances. (1) Except as provided in §§B(2) and C(2) of this regulations, drugs classified as Schedule II, Schedule III, Schedule IV, and Schedule V may not be returned to the inventory of the pharmacy. (2) Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the patient. D. A compounded sterile preparation may not be returned to the inventory of a pharmacy. E. Drugs requiring refrigeration may not be returned to the inventory of a pharmacy. F. Emergency Drug Kit. (1) The director of pharmacy or designee shall ensure that the emergency drug kit is secured with a tamper-evident seal or electronic security system which will indicate the opening of the kit. (2) Labeling. The director of pharmacy or designee shall ensure that the emergency drug kit meets the following specifications: (a) The exterior of the emergency drug kit is labeled to indicate clearly and unmistakably that it is an emergency drug kit and that it is for use in emergencies only; (b) The exterior of the emergency drug kit is labeled to indicate the: (i) Names of the drugs contained in the emergency drug kit; (ii) Strengths of the drugs contained in the emergency drug kit; (iii) List of contents with expiration dates, with the date of the first item to expire in bold print; and (iv) The quantity of each drug contained in the emergency drug kit; and (c) Medications contained in the emergency drug kit are labeled with the: (i) Name of the drug; (ii) Strength of the drug; (iii) Expiration date of the drug; (iv) Lot number of the drug; and (v) Other information required by the medical staff. (3) Replacement of Medications. (a) A licensed pharmacist or licensed pharmacist's designee shall replace the emergency drug kit or replenish used or expired drugs contained in the emergency drug kit within 72 hours of notification of use or expiration. (b) A licensed pharmacist shall perform the final check on the contents of the emergency drug kit. G. Interim Box. (1) An interim box may be provided by the pharmacy and kept at the comprehensive care facility if comprehensive care facility policies and procedures address an interim box and the pharmacy complies with these policies and procedures. (2) A licensed pharmacist shall perform the final check on the contents of the interim box. H. Prescriber Orders. (1) A licensed pharmacist shall dispense medications from the pharmacy only upon receipt of a valid written prescription, chart order, or verbal order from an authorized prescriber. (2) A chart order shall be considered a prescription drug order provided that the prescription drug order contains: (a) The full name of the patient; (b) The date of issuance; (c) The name, strength, and dosage form of the drug prescribed; (d) The name, type, and specifications of any device; (e) The directions for use; (f) If written, the authorized prescriber’s signature or the signature of the authorized prescriber’s agent (including the name of the authorized prescriber); (g) If electronically transmitted, prescription requirements as described in COMAR 10.34.20; and (h) If verbal, the name of the prescriber and the prescriber’s agent, if applicable. (3) A written order may be received by the pharmacy by facsimile, electronic transmission, or as the original physician order. (4) The licensed pharmacist shall document immediately a verbal order in writing. (5) A licensed pharmacist may receive a verbal order: (a) By telephone with the licensed pharmacist reading back the prescription to the prescriber or the prescriber’s agent; or (b) By a voice messaging system. I. Controlled Dangerous Substances. (1) Drug Accountability. The permit holder shall ensure that personnel employed by the pharmacy abide by the laws and regulations as defined in Health-General Article, Title 27, Annotated Code of Maryland, and COMAR 10.19.03. (2) Storage and Security. The permit holder shall establish effective procedures for storage and security of Schedule II controlled dangerous substances including limitation of access to these drugs in the pharmacy to licensed pharmacists and registered pharmacy technicians. J. Drug Recalls. The director of pharmacy or designee shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are returned to the pharmacy, sequestered, and handled as appropriate to the level of the recall. K. Adverse Drug Reactions. (1) The director of pharmacy or designee shall participate on the appropriate committee of the comprehensive care facility to establish procedures to report and record adverse drug reactions. (2) The director of pharmacy or designee shall ensure the procedures established include, at a minimum: (a) The reporting of significant adverse drug reactions to the attending prescriber or designee and other parties as specified by the committee of the comprehensive care facility; and (b) The recording in writing of an adverse reaction on the patient’s chart at the time it is reported. L. Records and Reports. The director of pharmacy or designee shall maintain records and reports as may be required by law, this chapter, and the policies of the comprehensive care facility. #### Regulation .10 Quality Management. *COMAR 10.34.23.10* The director of pharmacy or designee, in cooperation with the pharmaceutical services committee of the comprehensive care facility, shall be responsible for developing procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter. ### Chapter 24 — Record of Drug Inventory Acquisition **Authority:** Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland **Administrative History:** Effective date: September 17, 2001 (28:18 Md. R. 1621) #### Regulation .01 Purpose. *COMAR 10.34.24.01* The purpose of this chapter is to establish the minimum requirements for drug acquisition records to be maintained by pharmacy permit holders. #### Regulation .02 Scope. *COMAR 10.34.24.02* A. This chapter applies to all pharmacy permit holders in this State. B. This chapter applies to the acquisition of all prescription medication drug inventories. C. This chapter applies to a pharmacy's acquisition of drug inventory from all sources including, but not limited to, pharmacies, distributors, and manufacturers, and through all means including, but not limited to, purchases, barter or exchange, free goods, rebates, and replacement products. #### Regulation .03 Minimum Requirements for Maintenance of Drug Acquisition Records. *COMAR 10.34.24.03* A. A pharmacy permit holder shall maintain records of all drug inventory acquisitions. B. The records maintained shall include: (1) The name and principal address of the source of the drugs; (2) The identity and quantity of the drugs received; and (3) The date the drugs were received. C. The acquisition records shall be kept for a period of 2 years from the date the inventory was received. #### Regulation .04 Violation and Inspection. *COMAR 10.34.24.04* A. A pharmacy permit holder shall make the drug inventory acquisition records required under this chapter available for inspection upon request by any federal, state, or local law enforcement agent, or any other duly authorized agent of the Board of Pharmacy or the Division of Drug Control, within 72 hours of the request. B. A pharmacy permit holder shall produce and maintain the records required under this chapter for drug acquisitions for all acquisitions except those replaced within 7 days. ### Chapter 25 — Delivery of Prescriptions **Authority:** Health Occupations Article, §12-205(a)(3)(ii), Annotated Code of Maryland **Administrative History:** Effective date: December 10, 2001 (28:24 Md. R. 2128) **Administrative History:** Regulation .01 amended effective March 1, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .02B amended effective March 1, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective March 1, 2012 (39:1 Md. R. 17) **Administrative History:** Regulation .06 repealed effective March 1, 2012 (39:1 Md. R. 17) #### Regulation .01 Scope. *COMAR 10.34.25.01* This chapter governs the manner in which a Maryland licensed pharmacy delivers filled prescriptions for individual patients by United States Postal Service, common carrier, or delivery service to an address within the State. #### Regulation .02 Definitions. *COMAR 10.34.25.02* A. In this chapter, the following terms have the meaning indicated. B. Terms Defined. (1) “Delivery” means to send a prescription medication from a pharmacy by the United States Postal Service, common carrier, or delivery system to an address within the State. (2) Depot. (a) “Depot” means a location where filled prescriptions are stored before delivery to the intended patient or the intended patient's authorized agent. (b) “Depot” does not include: (i) A licensed health care facility; (ii) A prescriber's office; (iii) The prescription area of a pharmacy as defined by COMAR 10.34.05.01; (iv) The United States Postal Service or common carrier's warehouse; or (v) A multiple family residence. (3) “Patient” means the individual or companion animal for whom a prescription is written and to whom a prescription medication will be administered. (4) “Patient profile” means a record of dispensing activity maintained by a pharmacist for a specific patient. (5) “Residence” means the street address at which a patient resides. (6) “Storage” means the maintenance of a supply of medication before receipt of the medication by the patient or an agent authorized by the patient. #### Regulation .03 Requirements for Packaging and Delivery of Prescription Medication. *COMAR 10.34.25.03* A. Packaging. Prescription medications delivered under this chapter to individuals in the State shall be: (1) Enclosed in a container that reveals to the patient any tampering of the container that occurred during delivery or storage; (2) Packaged in a shipping container in a manner that does not indicate that the contents are medications; (3) Packaged in a manner that indicates: (a) The name and address of the patient or authorized agent; and (b) Any special storage conditions or requirements; and (4) Packaged to contain: (a) Written information regarding the prescription drug or device which is considered significant in the professional judgment of the pharmacist; (b) A local or toll-free telephone number for the pharmacy; and (c) Notification to the patient if the appearance of the patient’s medication has changed from the patient’s last refill. B. Delivery. (1) Location. (a) A prescription medication may be delivered to the patient for whom the prescription is prescribed, wherever the patient is located. (b) Instead of delivering medication directly to the patient under §B(1)(a) of this regulation, medication may be delivered to: (i) An agent authorized by the patient; or (ii) The residence of the patient, regardless of whether the patient is present at the residence at the time of delivery. (2) The pharmacy permit holder shall: (a) Enclose information to inform the patient if the patient’s prescription is a temperature sensitive medication that is at risk for damage due to extreme hot or cold temperatures or moisture: (i) During shipment; or (ii) After delivery to the patient’s mailbox or other designated location; and (b) Inform the patient within 24 hours of being notified of the delay if the scheduled delivery of the patient’s prescription will be interrupted or late. #### Regulation .04 Depots. *COMAR 10.34.25.04* A pharmacy may not knowingly deliver prescription medications to a depot, or establish or cooperate in the establishment of a depot. #### Regulation .05 Record Keeping. *COMAR 10.34.25.05* A. If a patient authorizes delivery of prescription medication to an agent at a location other than the pharmacy, or the patient's residence, the pharmacist shall document the authorization: (1) On the prescription; (2) In the patient profile; or (3) In another record maintained in the pharmacy and established for this purpose. B. If prescription medication is sent to an agent authorized by the patient at a location other than the patient's residence, or the place of business of the patient's authorized prescriber, the pharmacy shall maintain a record of the: (1) Identity of the agent to whom the medication is sent; (2) Location where the medication is sent; (3) Date and time the medication is sent; and (4) Prescription number or description of the medication sent. ### Chapter 26 — Patient Safety Improvement **Authority:** Health Occupations Article, §12-205(a)(3), Annotated Code of Maryland **Administrative History:** Effective date: October 27, 2003 (30:21 Md. R. 1529) #### Regulation .01 Definitions. *COMAR 10.34.26.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “High-alert medication” means a medication with: (a) A significant potential for involvement in a mediation error due to the medication's name, packaging, appearance, dosing, or other characteristics of the agent; or (b) A high potential for causing serious harm or injury if used incorrectly. (2) Medication Error. (a) “Medication error” means any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. (b) “Medication error” includes events that may be related to professional practice, health care products, procedures, and systems, including prescribing, order communication, product labeling, packaging, nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use. (3) Ongoing Quality Assurance Program. (a) “Ongoing quality assurance program” means a program that systematically and routinely reviews the medication delivery system of a pharmacy for the purpose of minimizing the occurrence of medication errors. (b) “Ongoing quality assurance program” includes: (i) The systematic and routine collection of information regarding the performance of the medication delivery system as it becomes available; (ii) The investigation of medication errors at the time the error is reported or discovered, or within a reasonable amount of time after the medication error is reported or discovered; or (iii) A record, proceeding, file, or other document maintained to comply with Regulations .03 or .04 of this chapter, COMAR 10.34.21.03, COMAR 10.34.28.09, or COMAR 10.34.28.10. #### Regulation .02 Patient Education. *COMAR 10.34.26.02* A. The pharmacy permit holder shall establish methods to provide patients with information regarding the patient's role and responsibility in preventing medication errors in a manner that is reasonably likely to convey the information to the patient, and if applicable, the patient's health care agent or surrogate decision maker, under Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland, and that is in addition to any other patient counseling or information required to be given by other laws and regulations. B. The information in §A of this regulation shall be provided to the patient before or at the time the drug or device is presented to the patient. C. Exception. If the patient is an inpatient at a health care facility, the information in §A of this regulation shall be: (1) Provided directly to a patient and, if applicable, a patient's health care agent or surrogate decision maker before discharge; or (2) Available in a conspicuous location on the institution's premises where the patient and, if applicable, the patient's health care agent or surrogate decision maker, are reasonably likely to have an opportunity to review the information. D. The information provided to patients shall include: (1) A patient's rights when receiving a medication or a prescription; (2) The patient's role and responsibility in preventing a medication error; (3) The procedures to follow when reporting a suspected medication error to the pharmacy permit holder, pharmacist, health care facility, or other healthcare provider; and (4) How to report a suspected medication error to the Board. #### Regulation .03 Pharmacy Staff Education. *COMAR 10.34.26.03* As part of a pharmacy permit holder's ongoing quality assurance program, the pharmacy permit holder shall: A. Ensure that each member of the pharmacy staff involved in the medication delivery system receive at least once a year, education regarding the role and responsibility of pharmacy staff in preventing medication errors; and B. Maintain records for a minimum of 2 years: (1) Verifying completion of education referred to in §A of this regulation; and (2) Demonstrating the content of the education. #### Regulation .04 Ongoing Quality Assurance Program. *COMAR 10.34.26.04* A. A pharmacy permit holder shall establish and maintain an ongoing quality assurance program to: (1) Identify, investigate, and promote the prevention of medication errors; and (2) Establish protocols and procedures to minimize the potential for medication errors. B. The ongoing quality assurance program shall include the records, proceedings, files, and any other documents of the ongoing quality assurance program, including for each medication error: (1) The date of the error; (2) A brief description of the error; (3) The results of the evaluation by the ongoing quality assurance program's investigation; and (4) Remedial action taken or recommendations. C. Periodic Review. (1) A pharmacy permit holder shall analyze the records, proceedings, files, and any other documents of the ongoing quality assurance program required under §B of this regulation, including any medication errors relating to automated medication systems or unlicensed personnel, at least every 3 months as part of the periodic review that is required to maintain an ongoing quality assurance program. (2) Each pharmacy permit holder shall conduct an analysis of its medication delivery system at least every 6 months to determine which medications in the prescription area of the pharmacy are high-alert medications, as part of the pharmacy's ongoing quality assurance program. D. Documentation of Periodic Review. The records, proceedings, files, and any other documents of the ongoing quality assurance program shall include for each: (1) Periodic review required under §C(1) of this regulation: (a) Documentation of the periodic review; (b) A description of the system's weaknesses found during the periodic review; and (c) A description of the actions taken to remedy any weaknesses identified in the medication system; and (2) Analysis of a pharmacy's medication delivery system to identify high-alert medications required under §C(2) of this regulation: (a) A list of high-alert medications present in the prescription area of the pharmacy; (b) The date that a high-alert medication was added to or removed from the list of high-alert medications; (c) Dates that the list was reviewed by the pharmacy permit holder; and (d) Remedial actions taken based on the review of the list of high-alert medications and any medication errors relating to the high-alert medications. E. Unless otherwise specified in law, the permit holder shall maintain the ongoing quality assurance program records referred to in this regulation for 2 years. F. The proceedings, records, and files of an ongoing quality assurance program that meets the requirements of Health Occupations Article, §1-401, Annotated Code of Maryland, and this chapter, are not discoverable and are not admissible in evidence in any civil action, as provided in Health Occupations Article, §1-401, Annotated Code of Maryland. ### Chapter 27 — Compelling Purpose Disclosure **Authority:** Health Occupations Article, §12-205(a)(3);State Government Article, §10-617(h)(3); Annotated Code of Maryland **Administrative History:** Effective date: January 7, 2002 (28:26 Md. R. 2273) **Administrative History:** Regulation .01 amended effective December 11, 2003 (30:24 Md. R. 1741) #### Regulation .01 Disclosure for Compelling Public Purpose. *COMAR 10.34.27.01* The custodian of records may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns: A. Possible criminal activity and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority; B. A possible violation of law and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation and the information disclosed is limited to information relevant to the possible violation by that individual; or C. Conduct by an individual that the custodian of records reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual, or to a hospital or other health care facility where the individual has privileges. #### Regulation .02 Other Disclosures. *COMAR 10.34.27.02* This chapter does not prohibit or limit the ability of the Board to disclose general licensing information as provided in State Government Article, §10-617(h), Annotated Code of Maryland, or any information that the Board may otherwise disclose by law. ### Chapter 28 — Automated Medication Systems **Authority:** Health Occupations Article, §§12-205(a) and 12-605, Annotated Code of Maryland **Administrative History:** Effective date: August 5, 2002 (29:15 Md. R. 1142) **Administrative History:** Chapter revised effective October 1, 2012 (39:7 Md. R. 493) #### Regulation .01 Scope. *COMAR 10.34.28.01* This chapter defines the parameters under which a permit holder may allow the use of automated medication systems to facilitate the dispensing and distribution of medication. #### Regulation .02 Definitions. *COMAR 10.34.28.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Automated medication system” means a centralized, decentralized, or remote robotic or computerized device and that device's components designed to: (a) Distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland; or (b) Prepare medications for final dispensing by a licensed pharmacist. (2) “Centralized automated medication system” means an automated medication system located in a pharmacy from which medication is distributed or prepared for final dispensing by a licensed pharmacist for a specific patient. (3) “Decentralized automated medication system” means an automated medication system that is located outside of the pharmacy in a health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland, with an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific. (4) “Distribution” means the process resulting in the provision of a prescription or nonprescription drug or device to a separate, intervening individual, licensed and practicing under Health Occupations Article, Annotated Code of Maryland, before the administration of the provided drug or device to a patient and pursuant to an order issued by an authorized prescriber. (5) “Health care facility” means a hospital or related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland. (6) “Interim box” means a tamper evident and secure container or secure electronic storage system holding minimal quantities of medications agreed on by the health care facility intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply. (7) Remote Automated Medication System. (a) “Remote automated medication system” means an automated medication system that is located in a health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland, that does not have an on-site pharmacy and in which medication is stored in a manner that may be, but need not be, patient specific. (b) “Remote automated medication system” does not include an interim box or other similar medication storage container that: (i) Does not operate pursuant to the entry of a medication order; (ii) Does not require a pharmacist’s review before access to medication; (iii) Is stocked with unit dose medications; (iv) Has the sole purpose of providing a medication dosage pending the next pharmacy delivery to the health care facility; (v) Is located in a patient care setting that does not have a pharmacy on site; and (vi) Is stocked and controlled by a pharmacy providing services to a health care facility. (8) “Responsible pharmacist” means a licensed pharmacist who ensures the safe and efficient dispensing, repackaging, delivery, control, positive drug identification including bar coding, transaction records, dispensation records, labeling, and accountability for medications in an automated medication system. (9) “Starter dose” means a dose of medication removed from a remote or decentralized automated medication system within the first 24 hours after it is ordered. (10) “Unit dose” means a medication container or package containing one discrete pharmaceutical dosage form labeled according to federal and State law. #### Regulation .03 Limitation on Privileges to Administer. *COMAR 10.34.28.03* In this chapter, “privileges to administer medication” does not include privileges created by delegation from a licensed health care professional to an unlicensed health care professional. #### Regulation .04 Usage Requirements for Centralized Automated Medication Systems. *COMAR 10.34.28.04* A. An automated medication system may only be used if: (1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter; (2) A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the centralized automated medication system; and (3) The permit holder ensures that: (a) Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland; (b) The centralized automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and (c) The centralized automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter. B. A permit holder shall indicate on the initial, renewal, and reinstatement applications: (1) Whether the permit holder operates a centralized automated medication system; and (2) Any other information regarding the system that the Board considers necessary to determine compliance with this chapter. #### Regulation .05 Usage Requirements for Decentralized Automated Medication Systems. *COMAR 10.34.28.05* A. A decentralized automated medication system may only be used if: (1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter; (2) A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the automated medication system; (3) Except for starter doses, a licensed pharmacist reviews each order for medication: (a) After the order has been entered into the system; and (b) Before the system permits access to the medication; (4) The permit holder ensures that: (a) Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland; (b) The decentralized automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and (c) The decentralized automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter; and (5) It is designed to distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland. B. A starter dose, or a dose in response to an emergency, may be distributed without prior review by a pharmacist of the order if: (1) The pharmacist reviews the order within 24 hours of removal from the decentralized automated medication system; or (2) The prescriber reviews the patient medical history and authorizes the administration of the dose to the patient. C. Decentralized automated medication systems shall operate in a manner which: (1) Limits simultaneous access to multiple: (a) Drug strengths; (b) Dosage forms; or (c) Drug entities; (2) Prevents access to medications not ordered for the patient; and (3) Safeguards against the misidentification of medications, dosages, and dosage forms by those accessing the decentralized automated medication system. D. The requirements listed in §C(1) and (2) of this regulation do not apply to automated supply towers which contain: (1) Noncontrolled medications that are: (a) Refrigerated; (b) Bulk; or (c) Intravenous fluids; or (2) Prescription devices. E. A permit holder shall indicate on the initial, renewal, and reinstatement applications: (1) Whether the permit holder operates a decentralized automated medication system; and (2) Any other information regarding the system that the Board considers necessary to determine compliance with this chapter. #### Regulation .06 Usage Requirements for Remote Automated Medication Systems. *COMAR 10.34.28.06* A. A remote automated medication system may only be used if: (1) Records concerning transactions or operations are maintained in accordance with Regulation .11 of this chapter; (2) A responsible pharmacist has been designated by the permit holder to supervise and manage the operations of the remote automated medication system; (3) Except for starter doses, a licensed pharmacist reviews each order for medication: (a) After the order has been entered into the system; and (b) Before the system permits access to the medication; (4) The permit holder ensures that: (a) Patients have prompt access to pharmacy services necessary for the provision of good pharmaceutical care as defined in Health Occupations Article, §12-101, Annotated Code of Maryland; (b) The remote automated medication system maintains the integrity of the information in the system and protects patient confidentiality; and (c) The remote automated medication system is subject to a quality assurance program in accordance with Regulation .10 of this chapter; and (5) It is designed to distribute medications in a licensed health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19-713.6, Annotated Code of Maryland. B. A starter dose, or a dose in response to an emergency, may be distributed without prior review by a pharmacist of the order if the pharmacist reviews the order within 24 hours of removal from the remote automated medication system. C. If a licensed pharmacist is not physically present where the remote automated medication system is located, the pharmacist shall have access to the system by electronic and visual means in order to ensure the safe and efficient operation of the system. D. Remote automated medication systems shall operate in a manner which: (1) Unless packaging and labeling for a specific patient, limits simultaneous access to multiple: (a) Drug strengths; (b) Dosage forms; or (c) Drug entities; (2) Prevents access to medication not ordered for the patient; and (3) Safeguards against the misidentification of medications, dosages, and dosage forms by those accessing the remote automated medication system. E. The requirements listed in §D(1) and (2) of this regulation do not apply to automated supply towers which contain: (1) Noncontrolled medications that are: (a) Refrigerated; (b) Bulk; or (c) Intravenous fluids; or (2) Prescription devices. F. A remote automated medication system may be used only if the system: (1) Uses positive drug identification, such as bar code technology, to ensure accuracy in: (a) Loading and selection of medications in the pharmacy for stocking and replenishment of the remote automated medication system; and (b) Loading medications into the remote automated medication system where it is located; (2) Has electronic reporting capability regarding the identity of persons with access to the system and regarding medications removed from the system; (3) Restricts access to medications to a licensed pharmacist or an individual authorized to administer medication under Health Occupation Article, Annotated Code of Maryland; and (4) Before administration of a medication to a patient, provides: (a) A picture of the medication, if available; or (b) If a picture is not available, a written description of the medication specifically by color, shape, and unique manufacturer markings. G. The permit holder shall ensure that the health care facility where the remote automated medication system is located provides, at a minimum: (1) A licensed pharmacist available for consultation 24 hours per day; (2) Technical assistance regarding operation of the system available 24 hours per day; and (3) A quality assurance program as set forth in Regulation .10 of this chapter. H. A permit holder shall indicate on the initial, renewal, and reinstatement applications: (1) Whether the permit holder operated a remote automated medication system; and (2) Any other information regarding the system that the Board considers necessary to determine compliance with this chapter. #### Regulation .07 Stocking of Automated Medication Systems. *COMAR 10.34.28.07* A. Selection of Medication for Stocking. A licensed pharmacist shall verify the accuracy of medications selected for stocking and replenishment of the automated medication system before the medications are stocked in the system. B. Stocking of Automated Medication System. A registered pharmacy technician may stock an automated medication system provided that: (1) The pharmacy technician’s selection of medications is verified by a pharmacist; and (2) The system uses positive drug identification such as bar code technology. #### Regulation .08 Return of Unused Medication. *COMAR 10.34.28.08* A. Single-Drug Unit Dose Packaging. (1) Automated medication systems that distribute medications in single-drug unit dose packaging may allow for return of unused medications to the system provided that: (a) The medication is returned to a designated common, secure, one-way returns bin; and (b) A licensed pharmacist determines whether the medication is in an unadulterated form. (2) Only a licensed pharmacist may return medications directly to the automated medication system under §A(1) of this regulation. B. Unused medications distributed from a remote or decentralized automated medication system in a manner other than single-drug unit dose packaging shall be: (1) Returned to a designated common, secure, one-way returns bin; and (2) Returned to the permit holder for proper disposal. C. Unused medications dispensed from a centralized automated medication system stocked with bulk medications may not be returned to the system. #### Regulation .09 Education and Training. *COMAR 10.34.28.09* The permit holder shall ensure that individuals authorized to utilize centralized, decentralized, or remote automated medication systems receive initial and annual training regarding: A. The capabilities and limitations of the system; B. Procedures for the operation of the system; and C. Procedures for system downtime. #### Regulation .10 Quality Assurance Program. *COMAR 10.34.28.10* A. The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the automated medication system that addresses, at minimum: (1) A testing program which includes daily accuracy sampling that verifies the integrity of the system; (2) Investigation of medication errors related to the automated medication system, and remedial actions taken; (3) Review of discrepancies and transaction reports to identify patterns of inappropriate use and access; (4) Review of the overall functioning of the system2; (5) Security and access: (6) Preventative maintenance; (7) Sanitation; (8) Storage conditions; (9) Inventory of drugs; (10) Drug procurement, delivery, and receipt; (11) Record keeping; (12) Proper labeling procedures; and (13) Protocols in the event of a power outage or other situation in which the services of the system are interrupted, that include: (a) A plan for insuring continuity of pharmacy services to patients; and (b) A plan for system recovery. B. The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the remote or decentralized automated medication system that addresses, at a minimum, system override management to include: (1) A list of medications that can be overridden which is limited to starter doses; and (2) Review of system overrides to ensure appropriate utilization. #### Regulation .11 Record Keeping. *COMAR 10.34.28.11* A. The permit holder and the responsible pharmacist shall maintain records regarding the automated medication system in a readily retrievable manner for at least 5 years. B. The records referred to in §A of this regulation shall include: (1) Maintenance records and service logs; (2) System failure reports; (3) Documentation of patient outcomes resulting from system failures; (4) Accuracy audits and system performance audits; (5) Copies of reports and analyses generated as part of the quality assurance program, including daily accuracy sampling; (6) Reports or databases related to level of access and changes in the level of access to the system; (7) Training records including: (a) Contents of the training program; (b) Dates of training completion; and (c) The identity of those attending the training program; (8) Records of destruction of medication waste removed from the system, to include an independent witness signature; and (9) Transaction information as follows: (a) Transactions involving medications stored in or removed, dispensed, or distributed from the system; (b) Medications dispensed or distributed for a patient, which shall be recorded to include the: (i) Identity of the particular automated medication system accessed; (ii) Identification of the individual accessing the system; (iii) Date of transaction; (iv) Name, strength, dosage form, and quantity of drug accessed; and (v) Name of the patient for whom the drug was accessed; and (c) Records of stocking or removal of medications from an automated medication system, which shall include the: (i) Date; (ii) Name, strength, dosage form, and quantity of drug stocked or removed; and (iii) Name, initials, or identification code of the individual stocking or removing drugs from the system. #### Regulation .12 Security. *COMAR 10.34.28.12* A. The responsible pharmacist shall ensure the security of the automated medication system. B. In order to restrict access to the automated medication system to authorized individuals, the responsible pharmacist shall, at a minimum: (1) Establish a clear process of how passwords will be assigned; (2) Develop procedures that prohibit the sharing of passwords and reuse of passwords; (3) Require that the system database be updated daily to remove inactive passwords; and (4) Require remote locking mechanisms for refrigerated storage associated with the system. #### Regulation .13 Laws and Compendial Standards. *COMAR 10.34.28.13* The responsible pharmacist shall ensure compliance with the laws and compendial standards for packaging and labeling. #### Regulation .14 Controlled Dangerous Substances. *COMAR 10.34.28.14* Controlled dangerous substances shall only be dispensed and distributed in accordance with applicable State and federal statutes and regulations. ### Chapter 29 — Drug Therapy Management **Authority:** Health Occupations Article, §§12-6A-01 — 12-6A-10, Annotated Code of Maryland **Administrative History:** Effective date: December 11, 2003 (30:24 Md. R. 1742) **Administrative History:** Chapter revised effective April 15, 2013 (40:7 Md. R. 611) **Administrative History:** Regulation .01B amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .02 amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .03 amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .04 amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .05 amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .06 amended effective March 28, 2016 (43:6 Md. R. 409) **Administrative History:** Regulation .07 amended effective March 28, 2016 (43:6 Md. R. 409) #### Regulation .01 Definitions. *COMAR 10.34.29.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Amendment” means a change to: (a) A protocol or prescriber-pharmacist agreement; or (b) The parties to the prescriber-pharmacist agreement. (2) “Applicants” means physicians, pharmacists, podiatrists, or certified advanced practice nurses with prescriptive authority submitting a prescriber-pharmacist agreement and protocol to their respective Boards. (2-1) “Authorized prescriber” means a licensed physician, licensed podiatrist, or certified advanced practice nurse with prescriptive authority under Health Occupations Article, §8-508, Annotated Code of Maryland. (3) “Boards” means the Board of Physicians, the Board of Pharmacy, the Board of Podiatric Medical Examiners, and the Board of Nursing. (4) “Condition” means a disease-state or health circumstance necessitating monitoring or intervention. (5) “Emergency first care” means triage of emergent conditions or treatment of the condition in those cases in which a protocol specifies treatment for the emergent condition. #### Regulation .02 Content of Protocol. *COMAR 10.34.29.02* A. A protocol shall: (1) Be: (a) Written; and (b) Condition or disease-state specific; and (2) Contain the following: (a) The condition that the protocol is designed to manage; (b) A list of medications that may be used under the auspices of the protocol; (c) Monitoring parameters including laboratory tests for the: (i) Condition; and (ii) Medication employed; (d) A list of circumstances requiring contact with the authorized prescriber or authorized prescribers who are a party to the prescriber-pharmacist agreement; (e) A statement prohibiting substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the authorized prescriber unless permitted in the therapy management contract; (f) A list of circumstances under which the pharmacist may alter doses, modify the treatment regimen, or switch the agent under the terms of the therapy management contract; (g) Information to be documented; (h) A listing of provisions within the protocol that may be customized within a therapy management contract; and (i) An action plan for situations when the pharmacist encounters a situation that is not addressed in the protocol. B. A protocol may authorize: (1) The modification, continuation, and discontinuation of drug therapy; (2) The ordering of laboratory tests; (3) Other patient care management measures related to monitoring or improving the outcomes of drug or device therapy; and (4) For protocols by a licensed physician and licensed pharmacist, the initiation of drug therapy under written, disease-state specific protocols. C. A protocol may not authorize acts that exceed the scope of practice of the parties to the prescriber-pharmacist agreement. D. Technical modifications to the protocol shall be registered with the Board of Pharmacy within 30 days of the technical modification. #### Regulation .03 Content of Prescriber-Pharmacist Agreement. *COMAR 10.34.29.03* A. The prescriber-pharmacist agreement shall contain the following: (1) The names and signatures of the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and pharmacists authorized to act under a therapy management contract; (2) The locations where the pharmacists may provide therapy management services; (3) The titles of the protocols to which the prescriber-pharmacist agreement pertains; (4) The methods and time frames by which documentation and routine communication will occur between the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and the pharmacists, including the time frames in which the pharmacist will fully update the patient’s record in writing; (5) The name, address, and telephone number of the party to the prescriber-pharmacist agreement who is to receive correspondence from the Boards related to the prescriber-pharmacist agreement; (6) A statement that the physicians, podiatrists, or certified advanced practice nurses with prescriptive authority and pharmacists shall comply with all State and federal laws relating to patient confidentiality; and (7) A list of devices available to the pharmacists performing under the prescriber-pharmacist agreement, which are relevant to the disease-states or conditions to be managed. B. Technical modifications to the prescriber-pharmacist agreement shall be registered with the Board of Pharmacy within 30 days of the technical modification. C. The party designated as the contact person to receive correspondence from the Boards shall ensure that the parties to the prescriber-pharmacist agreement are notified in a timely manner of the information received from the Boards. D. If the contact information for the party to the agreement designated to receive correspondence from the Boards changes, the designee shall notify the Boards of the change within 30 days of the change. #### Regulation .04 Requirements for Participation in Drug Therapy Management. *COMAR 10.34.29.04* A. In order to enter into a therapy management contract, a pharmacist: (1) Shall be licensed by and in good standing with the Board of Pharmacy; (2) Shall possess a Doctor of Pharmacy degree or equivalent training as established in §B of this regulation; (3) May not have: (a) A public final order by the Board of Pharmacy disciplining the pharmacist's license within the 5 years immediately before the application is submitted; or (b) Limitations placed on the pharmacist's license by the Board of Pharmacy in a public order; (4) Shall possess relevant advanced training as indicated by one of the following: (a) Certification as a specialist related to the disease state specified by the protocol by: (i) The Board of Pharmacy Specialties; (ii) The American Society of Consultant Pharmacist's Certified Geriatric Practitioner certification program; or (iii) Another credentialing body approved by the Board of Pharmacy; or (b) Successful completion of: (i) A residency accredited by the American Society of Health-Systems Pharmacists, a body approved by the Board of Pharmacy or offered by a body accredited by the Accreditation Council for Pharmacy Education; (ii) A certificate program approved by the Board of Pharmacy; (iii) A National Association of Boards of Pharmacy credentialing examination; or (iv) An examination approved by the Board of Pharmacy; (5) Shall have successfully completed: (a) 1,000 hours of relevant clinical experience; or (b) 320 hours in a structured experience program approved by the Board of Pharmacy; and (6) Shall document training related to the disease state specified in the protocol. B. A pharmacist who does not possess a Doctor of Pharmacy degree shall document that the pharmacist's training has included the following components: (1) Designing, implementing, monitoring, evaluating, and modifying or recommending modifications in drug therapy to insure effective, safe, and economical patient care; (2) Identifying, assessing, and solving medication-related problems, and providing clinical judgments as to the continuing effectiveness of individualized therapeutic plans and intended therapeutic outcomes; (3) Conducting appropriate physical assessments, evaluating patient problems, and ordering and monitoring medications and laboratory tests in accordance with established standards of practice; (4) Monitoring patients and patient populations regarding the purposes, uses, effects, and pharmacoeconomics of their medications and related therapy; (5) Providing emergency first care, including cardiopulmonary resuscitation; (6) Using clinical data to optimize therapeutic drug regimens; and (7) Documenting interventions and evaluating pharmaceutical care outcomes. C. The Board of Pharmacy shall determine whether the pharmacist meets the requirements of §§A and B of this regulation. D. An authorized prescriber who has entered into a prescriber-pharmacist agreement shall submit to the Boards that regulate the authorized prescriber a copy of: (1) The prescriber-pharmacist agreement; (2) Subsequent amendments made to the: (a) Prescriber-pharmacist agreement; or (b) Protocols specified in the prescriber-pharmacist agreement; and (3) Changes to participants of the: (a) Prescriber-pharmacist agreement; or (b) Protocols specified in the prescriber-pharmacist agreement. E. The Boards that regulate the authorized prescriber shall notify the authorized prescriber of any additional information needed within 30 days of the receipt of the submitted information. F. A licensed pharmacist who has entered into a prescriber-pharmacist agreement shall submit to the Board of Pharmacy a copy of: (1) The prescriber-pharmacist agreement; (2) Subsequent amendments made to the: (a) Prescriber-pharmacist agreement; or (b) Protocols specified in the prescriber-pharmacist agreement; and (3) Changes to participants of the: (a) Prescriber-pharmacist agreement; or (b) Protocols specified in the prescriber-pharmacist agreement. G. The Board of Pharmacy shall determine whether a pharmacist added under §F of this regulation meets the requirements of §§A and B of this regulation. H. The Board of Pharmacy shall notify the pharmacist of any additional information needed within 30 days of the receipt of the submitted information. #### Regulation .05 Guidelines for Use of Protocols. *COMAR 10.34.29.05* A. On receipt of specific instructions from the authorized prescriber regarding a specific patient, the pharmacist may execute the authorized prescriber’s specific instructions even if the instructions deviate from the protocol. B. The protocol may not prohibit the pharmacist from providing other pharmaceutical services that are within the pharmacist's scope of practice. C. Documentation of activities performed under a protocol or the authorized prescriber’s specific instructions shall be maintained in such a manner that it is accessible to the: (1) Authorized prescriber; and (2) Pharmacist. D. Documentation may be maintained in written or electronic form. E. Oral communications between the authorized prescriber and pharmacist shall be summarized in the documentation maintained by the pharmacist and forwarded to the authorized prescriber. F. Unless an alternative time period is stated in the prescriber-pharmacist agreement, the pharmacist shall inform the authorized prescriber within 48 hours if the pharmacist: (1) Modifies the dose or agent under the therapy management contract; (2) Detects an abnormal result from an assessment activity; or (3) Initiates drug therapy under a written, disease-state specific protocol, for protocols by a licensed physician and pharmacist. #### Regulation .06 Therapy Management Contracts. *COMAR 10.34.29.06* A. A therapy management contract shall be signed by the: (1) Authorized prescriber or authorized prescribers involved in the management of the patient under a prescriber-pharmacist agreement; (2) Pharmacist or pharmacists involved in the management of the patient under a prescriber-pharmacist agreement; and (3) Patient receiving care under the therapy management contract. B. A therapy management contract shall contain: (1) A list of allowable substitutions of chemically dissimilar drugs, if any; (2) A statement that: (a) None of the parties involved in the therapy management contract have been: (i) Coerced into participating in the therapy management contract; (ii) Given economic incentives, excluding normal reimbursement for services rendered; or (iii) Involuntarily required to participate in the therapy management contract; and (b) The pharmacist shall notify the authorized prescriber under the terms of the prescriber-pharmacist agreement if the pharmacist: (i) Modifies the dose or agent under the therapy management contract; or (ii) Detects an abnormal result from an assessment activity; (3) Notice to the patient stating: (a) That the patient may terminate the therapy management contract at any time; and (b) The procedure by which the patient may terminate the therapy management contract; (4) A procedure for periodic review by the authorized prescriber of the drugs modified under the prescriber-pharmacist agreement or changed with the consent of the authorized prescriber; (5) A reference to the protocol or protocols under which the pharmacist shall act; and (6) Exceptions or limitations to the protocol or protocols for the specific patient. #### Regulation .07 Fees. *COMAR 10.34.29.07* A. Scope. This regulation governs authorized prescribers and pharmacists participating in drug therapy management or amendment of authorized prescribers and pharmacists that participate in the prescriber-pharmacist agreements relating to drug therapy management. B. Fees. The Board of Pharmacy requires a fee for the prescriber-pharmacist agreement and protocol application (which includes review of the qualifications of the pharmacist participants) of $100 per prescriber-pharmacist agreement. ### Chapter 30 — Change to Permit — Pharmacy or Wholesale Distribution Permit Holder **Authority:** Health Occupations Article, §§12-205 and 12-206, Annotated Code of Maryland **Administrative History:** Effective date: November 10, 2003 (30:22 Md. R. 1582) **Administrative History:** Regulation .01 amended effective July 8, 2013 (40:13 Md. R. 1076) **Administrative History:** Regulation .01-1 adopted effective July 8, 2013 (40:13 Md. R. 1076) **Administrative History:** Chapter revised effective May 20, 2019 (46:10 Md. R. 489) #### Regulation .01 Application for Name Change. *COMAR 10.34.30.01* The name of an individual or entity required to possess a pharmacy or wholesale distribution permit may be changed on a permit if: A. The permit holder submits a notice of name change to the Board within 30 days after the name change, on a form that the Board requires; B. The permit holder submits to the Board documentation verifying the name change; and C. There is no other change in the individual or entity required to possess a pharmacy or wholesale distribution permit including no change in controlling ownership interest, type of business entity, or location. #### Regulation .02 Application for Name Change — Fee. *COMAR 10.34.30.02* There is no fee for a name change under this chapter. #### Regulation .03 Applications for Pharmacy or Wholesale Distributor Establishment Change of Ownership. *COMAR 10.34.30.03* If the controlling interest in ownership of a pharmacy or wholesale distributor changes, the new owner shall: A. Submit an initial application and fee for a pharmacy or wholesale distributor permit, as applicable; and B. Submit and comply with the requirements of closing and opening operations as set forth in: (1) COMAR 10.34.14, for pharmacies; and (2) Health Occupations Article, §12-6C-05(d), Annotated Code of Maryland, and COMAR 10.34.22.10, for wholesale distributors. #### Regulation .04 Applications for Pharmacy or Wholesale Distributor Establishment Change of Location. *COMAR 10.34.30.04* A. Permits issued to operate a pharmacy or engage in wholesale distribution, whether located in the State or outside the State, are: (1) Not transferable; and (2) Specific to the establishment location that has undergone an opening inspection by the Board. B. A pharmacy or wholesale distributor that intends to change its establishment location shall: (1) Submit an application to the Board on a form required by the Board; (2) If located in the State, comply with opening and closing inspection requirements in order to: (a) Commence operations at the new establishment location; and (b) Cease operations at the existing establishment location; and (3) If located outside the State, submit an inspection report for the new location conducted by the authorized entity in the state in which the establishment is located, or provide documentation of supplemental accreditation, if applicable. #### Regulation .05 Change of Information Provided in Applications. *COMAR 10.34.30.05* Notwithstanding any other reporting requirements, a permit holder shall provide written notification to the Board at least 30 days prior to any change in information in its application provided to the Board, to include: A. Change in hours of operation; or B. Change in the physical structure of the establishment, to include any: (1) Deviation from the floorplan submitted by the permit holder as part of the application; or (2) Other change that may affect the security or storage conditions of prescription drugs or devices. #### Regulation .06 Incomplete Applications. *COMAR 10.34.30.06* A. The Board may hold an incomplete initial or reinstatement application for a license, registration, or permit for up to one year from the date of receipt. B. After 1 year from the date of receipt, the Board shall close a pending application that is incomplete. C. If an application has been closed under §B of this regulation, the applicant shall submit a new application fee and otherwise comply with all applicable license, registration, or permit requirements. D. If an applicant presents extenuating circumstances to the Board, the Board may, in its sole discretion, extend the 1-year application completion period. ### Chapter 31 — Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit **Authority:** Health Occupations Article, §§12-205 and 12-307, Annotated Code of Maryland **Administrative History:** Effective date: March 1, 2004 (31:4 Md. R. 317) #### Regulation .01 Settings. *COMAR 10.34.31.01* A. If a setting otherwise complies with State and federal laws, a pharmacist may request Board approval to dispense or distribute at a setting that does not possess a pharmacy permit if: (1) The dispensing or distribution occurs while the pharmacist is providing drug therapy management services in: (a) The office of a licensed physician; (b) A clinic; or (c) A medical facility; or (2) The setting is: (a) Operated or funded by a public health authority of the State; (b) A medical facility or clinic that is operated on a nonprofit basis and is not otherwise required to possess a pharmacy permit; or (c) A health center that operates on a campus of an institution of higher education. B. If the drug therapy management services referred to in §A(1)(a) of this regulation include the dispensing or distribution of controlled dangerous substances, the request may be approved by the Board if the physician possesses a dispensing permit issued by the Board of Physicians. C. If a pharmacist seeks to obtain Board approval to dispense or distribute at a setting that is not set forth in §A of this regulation, the pharmacist shall apply to the Board for a waiver permit under COMAR 10.34.17. #### Regulation .02 Pharmacist Approval. *COMAR 10.34.31.02* A. Before a pharmacist may dispense or distribute at a setting that does not hold a pharmacy permit under Regulation .01A(1) of this chapter, the pharmacist shall submit to the Board a request for approval signed by the pharmacist, which includes: (1) The name and license number of the pharmacist; (2) The scope of services to be provided by the pharmacist at the nonpharmacy setting; (3) The name and address of the nonpharmacy setting where the pharmacist intends to dispense or distribute; and (4) A statement indicating the pharmacist's criminal history, if any. B. If the pharmacist intends to provide drug therapy management services in a licensed physician's office under Regulation .01A(1)(a) of this chapter, in addition to the requirements of §A of this regulation, the pharmacist shall provide: (1) The name and license number of the licensed physician; and (2) Proof of an approved physician-pharmacist agreement with the licensed physician. #### Regulation .03 Grounds for Denial. *COMAR 10.34.31.03* The Board may deny a pharmacist's request for approval under Regulation .02 of this chapter if the: A. Pharmacist has: (1) A pending or final disciplinary action before the Board; or (2) A criminal history; or B. Criteria set forth in Regulations .01B or .02 of this chapter are not satisfied. #### Regulation .04 Change in Information. *COMAR 10.34.31.04* If any of the information set forth in Regulation .02 of this chapter changes during the effective period of the Board's approval: A. The pharmacist shall immediately advise the Board in writing of the change; and B. The change in information may cause the Board to withdraw or modify the Board's approval of the nonpharmacy setting. #### Regulation .05 Approval During Catastrophic Health Emergency. *COMAR 10.34.31.05* In the event of a catastrophic health emergency proclaimed by the Governor under Article 41, §2-202, Annotated Code of Maryland, or by the Secretary under Health-General Article, §18-902, Annotated Code of Maryland, assignment of a pharmacist to a location by the State constitutes application and approval under Regulation .02 of this chapter. #### Regulation .06 Governing Laws. *COMAR 10.34.31.06* A. Except as provided in §B of this regulation, a pharmacist approved by the Board to dispense or distribute at a nonpharmacy setting shall comply with the Health Occupations Article, Title 12, Annotated Code of Maryland. B. A pharmacist approved by the Board to dispense or distribute at a nonpharmacy setting shall comply with the labeling, storage, and record keeping requirements governing the nonpharmacy setting. #### Regulation .07 Term and Renewal. *COMAR 10.34.31.07* A. Unless otherwise determined by the Board, the Board's approval of a pharmacist's request to dispense or distribute at a setting that does not possess a pharmacy permit is in effect until the expiration of the pharmacist's license. B. The pharmacist shall request renewal of the Board's approval when renewing the pharmacist's license. #### Regulation .08 Pharmacy Rendered Inoperable. *COMAR 10.34.31.08* A. If a pharmacy for which a permit is issued is destroyed or otherwise rendered inoperable, a pharmacist may dispense or distribute from a temporary site if the permit holder: (1) Obtains approval from the Board before continuing pharmacy operations from a temporary site; and (2) Ensures that the temporary pharmacy site complies with State and federal laws. B. Under §A of this regulation, the Board may approve the operation of a pharmacy from a temporary site for a period not to exceed 60 days from the date of the original approval, unless an extension is approved by the Board before the expiration of the preceding approval. ### Chapter 32 — Pharmacist Administration of Vaccinations **Authority:** Health Occupations Article, §§12-101, 12-102(b), 12-508, and 12-6A-10, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 adopted as an emergency provision effective December 16, 2005 (33:1 Md. R. 34); adopted permanently effective April 24, 2006 (33:8 Md. R. 734) **Administrative History:** Regulation .03A amended effective July 2, 2007 (34:13 Md. R. 1151) **Administrative History:** Regulation .08 adopted effective July 2, 2007 (34:13 Md. R. 1151) **Administrative History:** Chapter revised effective August 1, 2009 (36:15 Md. R. 1167) **Administrative History:** Regulation .03 amended as an emergency provision effective October 1, 2011 (38:24 Md. R. 1495); amended permanently effective January 23, 2012 (39:1 Md. R. 18) **Administrative History:** Chapter revised effective April 28, 2014 (41:8 Md. R. 472) **Administrative History:** Regulation .02B amended as an emergency provision effective November 20, 2025 (52:25 Md. R. 1266) **Administrative History:** Regulation .03 amended as an emergency provision effective November 20, 2025 (52:25 Md. R. 1266) **Administrative History:** Regulation .03D amended effective December 31, 2018 (45:26 Md. R. 1246) **Administrative History:** Regulations .04— .08 amended as an emergency provision effective November 20, 2025 (52:25 Md. R. 1266) #### Regulation .01 Scope. *COMAR 10.34.32.01* This chapter does not limit or affect the right of an individual to practice a health occupation that the individual is authorized to practice. #### Regulation .02 Definitions. *COMAR 10.34.32.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed. (3) “Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland. (4) “Pharmacy permit holder” means a person authorized by the Board to operate a pharmacy while the pharmacy permit is effective. (5) “Pharmacy Experiential Program” means a program under the American Council on Pharmacy Education. (6) “Practice pharmacy” means to engage in the activities set forth in Health Occupations Article, §12-101(x)(1), Annotated Code of Maryland. (7) “Primary care provider” means a health care practitioner who provides an individual’s primary care services and is the primary coordinator of health care services for the individual. (8) “Vaccination” means: (a) A vaccination that is listed in the Centers for Disease Control and Prevention’s Recommended Immunization Adult Schedule; (b) A vaccination recommended in the Centers for Disease Control and Prevention’s Health Information for International Travel; (c) A vaccination recommended for individuals between 7 years old and 18 years old by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices for Persons aged 0 through 18 years old; (d) An influenza vaccination; (e) A COVID vaccination; or (f) A vaccination approved or authorized by the U.S. Food and Drug Administration. (9) “Vaccine information statement” means the information sheet, produced by the Centers for Disease Control and Prevention that explains both the benefits and risks of a specific vaccine to the vaccine recipient, their parent, or their legal representative. **Emergency Action:** 52:25 25-248-E (Regulations .02—.08) EMERGENCY ACTION IN EFFECT 11/20/2025 —5/19/2026 #### Regulation .03 Requirements to Administer Vaccinations. *COMAR 10.34.32.03* A. Registration. (1) A licensed pharmacist shall submit a registration to the Board on the form that the Board requires. (2) The registration form shall include verification from the licensed pharmacist of the following: (a) That the pharmacist has completed a practical training program of at least 20 hours that is approved by the Accreditation Council for Pharmacy Education and includes education on: (i) Hands-on injection techniques; (ii) Clinical evaluation of indication and contraindications of vaccines; (iii) The recognition and treatment of emergency reaction to vaccines; and (iv) Guidelines and recommendations of the Centers for Disease Control and Prevention regarding vaccinations in effect on December 31, 2024; and (b) Possession of an active certification in basic cardiopulmonary resuscitation obtained through in-person classroom instruction. (3) A registration authorizing a licensed pharmacist to administer vaccinations expires with the expiration of the license to practice pharmacy unless the licensed pharmacist has completed: (a) Two hours of continuing education credits related to vaccinations; and (b) All other requirements for licensure renewal. (4) A licensed pharmacist may not administer vaccinations until the licensed pharmacist receives a written confirmation from the Board accepting the licensed pharmacist's registration. B. A licensed pharmacist may order and administer a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter to an individual who is at least 3 years old provided that: (1) The vaccine is: (a) An influenza vaccine; (b) A COVID vaccine; or (c) Used in response to a public health emergency; and (2) If the vaccination is administered to an individual under the age of 18 years, the pharmacist shall: (a) Inform the child vaccination patient and the adult caregiver who is accompanying the child of the importance of well-child visits with a pediatric primary care provider; and (b) Refer the child vaccination patient to a pediatric care provider when appropriate. B-1. (1) A pharmacist may order and administer a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter to an individual who is at least 7 years old provided that: (a) The vaccine: (i) Is recommended by the Center for Disease Control and Prevention Advisory Committee on Immunization Practices; or (ii) Approved or authorized by the U.S. Food and Drug Administration; and (b) If the vaccination is administered to an individual under the age of 18 years, the pharmacist shall: (i) Inform the child vaccination patient and the adult caregiver who is accompanying the child of the importance of well-child visits with a pediatric primary care provider; and (ii) Refer the child vaccination patient to a pediatric care provider when appropriate. (2) The recommendations of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices cited in this regulation refer to federal statutes, rules, and guidance: (a) In effect on December 31, 2024; or (b) At a later date to account for any new vaccines recommended by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices after December 31, 2024. B-2. A licensed pharmacist may order and administer to an adult a vaccination in accordance with a protocol that meets the requirements of Regulation .06 of this chapter that is listed in the Center for Disease Control and Prevention’s Health Information for International Travel. C. A pharmacist shall report to the ImmuNet Program established under Health-General Article, §18-109, Annotated Code of Maryland, a vaccination administered by the pharmacist to an individual. D. A pharmacist shall: (1) Have proof of active certification in basic cardiopulmonary resuscitation readily available. (2) Provide the patient with a vaccine information statement issued by the Centers for Disease Control and Prevention; (3) Obtain a signed consent form from the patient or custodial parent; and (4) Observe the patient for a period of at least 15 minutes after administration of the vaccine for adverse effects including syncope. E. A pharmacy student in a Pharmacy Experiential Program, who has successfully completed a Board-approved certification course, may administer vaccinations under direct supervision of a licensed pharmacist who meets requirements in §A of this regulation. #### Regulation .04 Record Keeping. *COMAR 10.34.32.04* A. The pharmacy permit holder shall maintain documentation in the pharmacy from which the vaccine was administered for a minimum of 5 years that includes: (1) The name, address, and date of birth of the individual receiving the vaccination; (2) The date of administration and route and site of vaccinations; (3) The name, dose, manufacturer’s lot number, and expiration date of the vaccine; (4) The name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual; (5) The name of the pharmacist, pharmacy student, physician, or nurse administering the vaccination; (6) The version of the vaccination information statement provided to the individual receiving the vaccination; (7) The copy of the signed patient consent form of those individuals to whom the vaccine was administered; (8) The nature and outcome of an adverse reaction and documentation that the adverse reaction was reported to: (a) The primary care provider; and (b) The Vaccine Adverse Event Reporting System. (9) At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and (10) If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered. B. The records required in this regulation shall be: (1) Readily retrievable; (2) Made available on the request of the Board; (3) Except for records related to minor patients, maintained for a minimum of 5 years; and (4) In the case of a minor patient, maintained until the patient attains the age of majority plus 3 years or for 5 years after the record is made, whichever is later. C. The pharmacist administering a vaccination as an independent provider at a location that is not a pharmacy shall maintain the following documentation for a minimum of 5 years: (1) Name, address, and date of birth of the individual receiving the vaccination; (2) Date of administration, and route and site of vaccinations; (3) Name, dose, manufacturer's lot number, and expiration date of the vaccine; (4) Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual; (5) Name of the pharmacist or pharmacy student administering the vaccination; (6) Version of the vaccination information statement provided to the individual receiving the vaccination; (7) Copy of the signed patient consent form of those individuals to whom the vaccine was administered; (8) Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to: (a) The primary care provider; and (b) The Vaccine Adverse Event Reporting System. (9) At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and (10) If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered. D. The pharmacist administering a vaccination on behalf of a permit holder at a location that is not a pharmacy shall maintain the following documentation with the permit holder for a minimum of 5 years: (1) Name, address, and date of birth of the individual receiving the vaccination; (2) Date of administration, and route and site of vaccinations; (3) Name, dose, manufacturer's lot number, and expiration date of the vaccine; (4) Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual; (5) Name of the pharmacist or pharmacy student administering the vaccination; (6) Version of the vaccination information statement provided to the individual receiving the vaccination; (7) Copy of the signed patient consent form of those individuals to whom the vaccine was administered; (8) Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to: (a) The primary care provider; and (b) The Vaccine Adverse Event Reporting System. (9) At least one effort made by the pharmacist to inform the individual’s authorized prescriber that the vaccination has been administered; and (10) If the authorized prescriber is not the individual’s primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual’s primary care provider or other usual source of care that the vaccination has been administered. #### Regulation .05 Patient Information and Consent. *COMAR 10.34.32.05* A. Every patient receiving a vaccination shall be provided with a current vaccine information statement. B. Every patient receiving a vaccination shall: (1) Sign a consent form consenting to the administration of the vaccine; and (2) Be given a copy of the consent form for the patient's future reference. C. The consent form shall disclose the credentials of the pharmacist administering the vaccination. #### Regulation .06 Approved Protocols. *COMAR 10.34.32.06* A. A pharmacist shall have and maintain a written protocol for any vaccine to be administered, including influenza vaccination. B. The pharmacist shall administer vaccinations in accordance with the written protocol. C. The written protocol for each vaccine shall contain at least the following elements: (1) Identity and license number of the participating pharmacist; (2) Vaccine; (3) Precautions to vaccine use; (4) Contraindications to vaccine use; (5) Process to be followed for screening for: (a) Indications; (b) Precautions; (c) Contraindications; and (d) Allergies; (6) Process for obtaining and documenting consent; (7) Process for verification of prescription for patients 11—17 years old for vaccinations other than the influenza vaccine; (8) Dose or doses of the vaccine that will be administered; (9) The route or routes and site or sites of administration of the vaccine; (10) The injection or administration procedures; (11) Post-vaccination procedures, including waiting requirements; (12) Process for handling adverse reactions, including but not limited to: (a) Acute anaphylactic reactions; and (b) Other acute emergencies; and (13) Process for documenting and maintaining a vaccination record including at least: (a) Patient: (i) Name; (ii) Date of birth; and (iii) Address; (b) Vaccination administration: (i) Date; (ii) Dose; (iii) Site; and (iv) Route; (c) Vaccine: (i) Manufacturer; (ii) Lot number; and (iii) Expiration date; (d) Required Vaccine Information Statement: (i) Version; and (ii) Provision date; (e) Name of the patient’s primary care provider or prescriber; (f) Documentation: (i) Of at least one attempt to inform the patient’s primary care provider or prescriber that the vaccination has been administered; or (ii) That the patient has no primary care provider; (g) Documentation of an attempt to inform the patient’s primary care provider that the influenza vaccination has been administered may not be required; and (h) The name of the vaccinator. D. The protocol shall be: (1) Signed and dated at least annually by the pharmacist; (2) Available and presented for inspection to the Board of Pharmacy upon request; and (3) Reviewed and updated as necessary. #### Regulation .07 Fees. *COMAR 10.34.32.07* Fees charged for the administration of vaccinations may not exceed $50 in addition to the cost of each vaccination. ### Chapter 33 — Prescription Drug Repository Program **Authority:** Health-General Article, §§15-601 — 15-609, Annotated Code of Maryland **Administrative History:** Effective date: January 29, 2007 (34:2 Md. R. 137) **Administrative History:** Chapter revised effective May 9, 2016 (43:9 Md. R. 530) #### Regulation .01-1 Incorporation by Reference. *COMAR 10.34.33.01-1* In this chapter, the Secure and Responsible Drug Disposal Act of 2010, 21 U.S.C. 822 (as amended), has been incorporated by reference. #### Regulation .01 Definitions. *COMAR 10.34.33.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (1-1) “Donation program” means pharmacies that voluntarily participate as a drop-off site or repository, or both, to accept donated drugs or medical supplies for purposes of re-dispensing those donated drugs or medical supplies to needy individuals. (1-2) “Disposal program” means pharmacies that voluntarily participate as repositories to collect returned drugs and medical supplies for purposes of safe disposal. (2) “Drop-off site” means a pharmacy or other health care facility designated by the Board for the purpose of receiving donated prescription drugs or medical supplies as part of the donation program and forwarding the drugs or medical supplies to a repository. (3) Health Care Facility. (a) “Health care facility” means: (i) A hospital, as defined in Health-General Article, §19-301(g), Annotated Code of Maryland; (ii) A limited service hospital, as defined in Health-General Article, §19-301(e), Annotated Code of Maryland; (iii) A related institution, as defined in Health-General Article, §19-301(o), Annotated Code of Maryland; (iv) An ambulatory surgical facility; (v) A rehabilitation facility; (vi) A home health agency, as defined in Health-General Article, §19-401(b), Annotated Code of Maryland; (vii) A hospice, as defined in Health-General Article, §19-901, Annotated Code of Maryland; (viii) A kidney disease treatment facility, or the kidney disease treatment stations and services provided by or on behalf of a hospital, if the facility or the services do not include kidney transplant services or programs; (ix) The office of one or more individuals licensed to practice dentistry under Health Occupations Article, Title 4, Annotated Code of Maryland, for the purposes of practicing dentistry; (x) A comprehensive care facility located in Maryland; or (xi) Other health institutions, services, or programs that may be specified as requiring a Certificate of Need under State law. (b) “Health care facility” does not mean a hospital or related institution operated, or listed and certified, by the First Church of Christ Scientist, Boston, Massachusetts. (4) “Health care practitioner” means an individual who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession and has prescribing authority in this State. (5) “Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed. (6) “Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland. (7) “Program” means the Prescription Drug Repository Program. (8) “Repository” means a pharmacy that applies to and is designated by the Board for the purpose of: (a) Accepting, inspecting, and dispensing donated prescription drugs or medical supplies received from a drop-off site as part of the donation program; and (b) Collecting prescription drugs or medical supplies for disposal as part of the disposal program. #### Regulation .02 Donation Program — Eligible Drugs. *COMAR 10.34.33.02* A. Prescription drugs or medical supplies may be donated at a drop-off site. B. Prescription drugs or medical supplies may be accepted for dispensing if the prescription drugs and medical supplies are: (1) In their original unopened and sealed packaging; or (2) Packaged in single unit doses when the outside packaging is opened if the single unit dose packaging is undisturbed. #### Regulation .03 Donation Program — Ineligible Drugs. *COMAR 10.34.33.03* A. Prescription drugs or medical supplies may not be accepted for dispensing if the prescription drugs or medical supplies: (1) Bear an expiration date that is less than 90 days from the date the drug is donated to ensure the potency and quality of the prescription drugs or medical supplies; (2) Have been adulterated, according to the standards of Health-General Article, §21-216, Annotated Code of Maryland, because adulterated prescription drugs or medical supplies have been determined to be a threat to public health; (3) Are designated controlled dangerous substances by the U.S. Drug Enforcement Administration which has determined that controlled dangerous substances may not be donated under a repository program; (4) Require refrigeration because the potency and quality may not be guaranteed; or (5) Have been previously compounded because compounded prescription drugs are patient specific. B. The repository shall dispose of donated prescription drugs or medical supplies if they are not accepted into the Program for the purpose of dispensing. #### Regulation .04 Donation Program — Donor Form. *COMAR 10.34.33.04* A. A donor of a prescription drug or medical supply shall sign a form containing the following statements: (1) That the donor is the owner or the owner's representative of the prescription drug or medical supply; and (2) That the donor intends to voluntarily donate the prescription drug or medical supply to the Program. B. The drop-off site shall: (1) Require that the donor form contain: (a) The signature of the donor or the donor's representative; (b) Contact information of the donor or the donor's representative; and (c) The date of donation; (2) Require that the donor form be completed before any donation; (3) Provide a copy of the donor form to the donor or the donor's representative; and (4) Maintain a copy of the donor form for 5 years. #### Regulation .05 Donation Program — Drop-Off Sites Requirements. *COMAR 10.34.33.05* A. In order to become a drop-off site, a pharmacy or other health care facility: (1) Shall submit an application to the Board to be designated as a voluntary drop-off site; (2) Shall be in good standing with the Board or the Office of Health Care Quality; (3) May not have a final disciplinary order issued against it by a health occupations board; (4) May not be owned or operated by a health care practitioner who has not fulfilled the requirements of a final disciplinary order that may have been issued against the owner or operator by a health occupations boards; (5) Shall maintain records of donated prescription drugs or medical supplies; and (6) Shall assign a pharmacist or other health care practitioner the responsibility to accept donated prescription drugs or medical supplies at the drop-off site. B. Assigned Pharmacist or Other Health Care Practitioner's Responsibility. A pharmacist or health care practitioner accepting donated prescription drugs or medical supplies at a drop-off site as set forth in §A(6) of this regulation: (1) May not delegate acceptance of donated prescription drugs or medical supplies; (2) May refuse to accept hazardous prescription drugs or medical supplies for donation if the decision is based on professional judgment, experience, knowledge, or available reference materials; (3) Shall be in good standing with the pharmacist's or health care practitioner's respective health occupations board; and (4) Shall have fulfilled the requirements of a final disciplinary order that may have been issued against the pharmacist or health care practitioner by a health occupations board. C. Record Requirements. A drop-off site shall: (1) Obtain a signed donor form releasing the prescription drug or medical supplies to the Program; (2) Provide a copy of the signed donor form to the donor; and (3) Maintain records of signed donor forms for 5 years. D. Procedures for Handling of Donated Prescription Drugs or Medical Supplies. (1) A drop-off site shall: (a) Place the donated prescription drug or medical supply and the donor form in a sealed bag; (b) Store the bag containing the donated prescription drugs or medical supplies in an area accessible only to those pharmacists or health care practitioners who have been assigned the responsibility to accept the donated prescription drugs or medical supplies; and (c) Forward the sealed bags of donated prescription drugs or medical supplies to the repository at least every 2 weeks. (2) A drop-off site may not: (a) Dispense donated prescription drugs or medical supplies; (b) Resell prescription drugs or medical supplies donated to the Program; (c) Charge a fee for accepting a donation; (d) Accept donated prescription drugs or medical supplies until the drop-off site applicant has been approved by the Board; or (e) Accept prescription drugs for disposal. #### Regulation .06-1 Repositories Participating in the Donation Program. *COMAR 10.34.33.06-1* A. Designated Pharmacist. A repository in the donation program shall designate a pharmacist who shall: (1) Accept donated prescription drugs or medical supplies forwarded by: (a) A drop-off site; or (b) A manufacturer regulated by the U.S. Food and Drug Administration; (2) Inspect donated prescription drugs or medical supplies; (3) Accept donated prescription drugs or medical supplies that meet the requirements of Regulations .02 and .03 of this chapter; and (4) Obliterate from the labels of donated prescription drugs or medical supplies patient specific information for which the donated prescription drugs or medical supplies were originally dispensed when it is placed in inventory. B. Record Requirements. A repository in the Donation Program shall: (1) Maintain a separate inventory of donated prescription drugs or medical supplies for a minimum of 5 years; (2) Maintain separate prescription files for patients receiving donated prescription drugs or medical supplies for a minimum of 5 years; and (3) Submit an annual report on its activities to the Board that includes at least information on the: (a) Number of recipients by county; (b) Approximate market value of the prescription drugs or medical supplies dispensed; (c) 50 prescription drugs or medical supplies most frequently dispensed; and (d) Total number of donations to the Program. C. Procedures for Handling of Donated Prescription Drugs or Medical Supplies. (1) A repository in the Donation Program shall store donated prescription drugs or medical supplies in a secure location separate from other inventory in accordance with State and federal laws and regulations. (2) A repository may not: (a) Resell prescription drugs or medical supplies donated to the Program; or (b) Establish or maintain a waiting list for prescription drugs or medical supplies dispensed by the Program. (3) A repository may charge a fee of not more than $10 for each prescription drug or medical supply dispensed under the Program. D. Limitations. A repository in the Donation Program is under no obligation to obtain a prescription drug or medical supply that is not in inventory at the time of the request. E. Procedure for Dispensing Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall dispense donated prescription drugs or medical supplies in compliance with applicable federal and State laws and regulations for dispensing prescription drugs or medical supplies. F. Procedure for Shipping Donated Prescription Drugs or Medical Supplies. A repository in the Donation Program shall comply with COMAR 10.34.25 when shipping donated prescription drugs or medical supplies to recipients of this Program. G. Procedures for Disposing of Donated Prescription Drugs or Medical Supplies. (1) A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies that do not meet the eligibility requirements of Regulation .02 of this chapter. (2) A repository in the Donation Program shall dispose of donated prescription drugs or medical supplies in compliance with applicable State and federal laws and regulations for disposing of prescription drugs or medical supplies. (3) A repository shall maintain records of disposal of donated prescription drugs or medical supplies. H. Determination of Patient Eligibility for the Donation Program. (1) A recipient of the Donation Program shall be a resident of the State. (2) A health care practitioner with prescribing authority shall: (a) Determine, at the health care practitioner’s discretion, the financial need of a patient to participate in the Donation Program; and (b) Indicate on the patient’s prescription eligibility for the Donation Program. I. Recipient Form. Recipients of a donated prescription drug or medical supply under the Donation Program shall sign a Board approved form before receiving the prescription drug or medical supply to confirm that the recipient understands that: (1) The recipient is receiving prescription drugs or medical supplies that have been donated as part of the Donation Program; and (2) Entities involved in the Donation Program have immunity from liability in accordance with Health-General Article, §15-607, Annotated Code of Maryland. #### Regulation .06 Repositories — General Requirements. *COMAR 10.34.33.06* In order to become a repository, a pharmacy: A. Shall submit an application to the Board to be designated as a repository; B. Shall indicate on the application to the Board if the applicant intends to: (1) Participate in the Donation Program; (2) Participate in the Disposal Program by collecting only non-controlled dangerous substances and medical supplies for safe disposal; or (3) Participate in the Disposal Program by collecting controlled dangerous substances, non-controlled dangerous substances, and medical supplies for safe disposal; C. Shall be in good standing with the Board; D. May not have a final disciplinary order issued against it by the Board; and E. May not be owned or operated by a health care practitioner who has not fulfilled the requirements of a final disciplinary order that may have been issued against the owner or operator by a health occupations board. #### Regulation .07 Disposal Program — Requirements. *COMAR 10.34.33.07* A. Pharmacies that collect returned prescription drugs or medical supplies for proper disposal shall be approved by the Board as repositories. B. Repositories that collect only non-controlled dangerous substances for proper disposal shall: (1) Dispose of prescription drugs or medical supplies collected for disposal in compliance with applicable State and federal laws and regulations; (2) Have policies and procedures regarding the safe and secure handling and disposal of prescription drugs and medical supplies, to include specific guidelines for prescription drugs requiring special disposal or care; (3) Dispose of collected prescription drugs and medical supplies through a third party processor or a reverse distributor, as appropriate; and (4) Maintain a separate secure container behind the prescription counter that is clearly marked for the Disposal Program. C. A pharmacist may not delegate to a pharmacy technician the collection of prescription drugs or medical supplies under §B of this regulation. D. Repositories that collect controlled dangerous substances for disposal: (1) Shall comply with the requirements of the Secure and Responsible Drug Disposal Act of 2010; (2) May collect non-controlled dangerous substances and medical supplies in the same manner; and (3) May commingle the collection of controlled and non-controlled dangerous substances and medical supplies in accordance with the Secure and Responsible Drug Disposal Act of 2010. ### Chapter 34 — Pharmacy Technicians **Authority:** Health-Occupations Article, §§12-101, 12-205, 12-206, 12-315—12-317, 12-319, 12-320, 12-403, 12-505, 12-707, and 12-6B-01—12-6B-14, Annotated Code of Maryland **Administrative History:** Effective date: January 28, 2008 (35:2 Md. R. 127) **Administrative History:** Regulation .05 amended effective July 1, 2015 (42:7 Md. R. 569); February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Chapter revised effective January 28, 2024 (50:26 Md. R. 1132) **Administrative History:** Regulation .02B amended effective November 11, 2024 (51:22 Md. R. 963) **Administrative History:** Regulation .03 amended effective November 11, 2024 (51:22 Md. R. 963) **Administrative History:** Regulation .07 amended effective November 11, 2024 (51:22 Md. R. 963) **Administrative History:** Regulation .10A amended effective November 11, 2024 (51:22 Md. R. 963) #### Regulation .01 Scope. *COMAR 10.34.34.01* This chapter applies to applicants for registration as pharmacy technicians and to registered pharmacy technicians. #### Regulation .02 Definitions. *COMAR 10.34.34.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) Compounding. (a) “Compounding” means the preparation, mixing, assembling, packaging, or labeling of a drug or device: (i) As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice; or (ii) For the purpose of, or incident to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device. (b) “Compounding” includes the preparation of drugs or devices in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns. (3) Delegated Pharmacy Act. (a) “Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter. (b) “Delegated pharmacy act” does not include: (i) An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland; (ii) The delegation of a pharmacy act by a registered pharmacy technician, pharmacy student, or pharmacy technician trainee; (iii) A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland; or (iv) A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months. (4) “Direct supervision” means that a licensed pharmacist is physically available onsite to supervise the performance of delegated pharmacy acts. (5) “Experiential learning rotation” means a course offered by an Accreditation Council for Pharmacy Education accredited school of pharmacy that is designed to provide pharmacy practice experiences to students seeking the doctor of pharmacy degree. (6) Final Product Verification. (a) “Final product verification” means: (i) Confirming the accuracy of the device or drug product, and dosage form of a filled prescription or medication order; or (ii) Confirming the accuracy of the device or drug product, and dosage form of a prescription or medication selected for stocking into a medication distribution system. (b) “Final product verification” does not include determining the appropriateness of the prescription device or drug product, dosage form, directions for use, labeling, packaging, or any other determination that requires the application of a pharmacist’s clinical expertise. (7) “Medication distribution system” means an automated medication system, emergency box, interim box, medication carousel or cart, or other storage and dispensing system. (8) “National pharmacy technician certification program” means a program approved by a Board-recognized national accrediting body. (9) “Pharmacy student” means an individual who is enrolled as a student in a school or college of pharmacy approved by the Board or accredited by the Accreditation Council for Pharmacy Education. (10) “Pharmacy technician trainee” means an individual engaged in a Board-approved pharmacy technician training program. (11) “Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts. (12) “Registration” means, unless the context requires otherwise, a registration issued by the Board to perform delegated pharmacy acts under the direct supervision of a licensed pharmacist. (13) “Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual. (14) “Unit dose” means a package labeled with bar code scanning or other similar technology containing a single dose of a device, drug, or medication ordered or prescribed for a patient. (15) “Unit-of-use” means a package or container, such as a unit dose (injectable, liquid, or solid), otic, ophthalmic product, otic product, topical product, or a prescription vial filled from a stock bottle or in the original manufacturer’s packaging, designed to be dispensed to a patient that is labeled with bar code scanning or other similar technology. (16) “Validated pharmacy technician” means a registered pharmacy technician who has obtained a product verification certificate issued by a Board-approved national training program and satisfied other regulatory requirements. #### Regulation .03 Delegated Pharmacy Acts. *COMAR 10.34.34.03* A. A pharmacy technician may not: (1) Represent themselves as a pharmacist; (2) Dispense prescription medications when the pharmacist is not in the pharmacy; (3) Be present in the pharmacy when the pharmacist is not physically available onsite; (4) Provide information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices; (5) Delegate a pharmacy act that was delegated to the pharmacy technician or individual engaging in a Board-approved technician training program; (6) Act within the parameters of a therapy management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland; (7) Provide the final verification for accuracy, appropriateness, completeness, or validity of a filled prescription or medication order, except as provided for in Regulation .04 under this chapter; (8) Make decisions that require a pharmacist's professional judgment; (9) Clinically evaluate the patient's profile relative to the pharmaceuticals that have been or will be dispensed; (10) Consult with the patient concerning the utilization of their pharmaceuticals; (11) Accept or transcribe new prescriptions; (12) Give or accept a transferred prescription for controlled dangerous substances; (13) Accept a transferred prescription; (14) Independently compound prescriptions; (15) Administer medications; (16) Accept the return of prescription drugs or devices directly from a patient. (17) Administer an injectable medication; or (18) Except as provided in §B of this regulation, administer a vaccine. B. Technician Administration of Certain Vaccines. (1) A registered pharmacy technician that meets the requirements set forth in §B(2) and (3) of this regulation, may administer the following vaccines as a delegated pharmacy act: (a) Coronavirus (COVID-19), influenza, or pneumococcal pneumonia vaccines to an individual 18 years old or older; or (b) Respiratory syncytial virus (RSV) or herpes zoster vaccines to an individual 50 years old or older. (2) In order for a registered pharmacy technician to administer a vaccine, the registered pharmacy technician shall submit notification to the Board on a form that the Board requires attesting to the following: (a) Successful completion of a practical training program approved by the Accreditation Council for Pharmacy Education (ACPE) that includes: (i) Hands-on injection technique; (ii) Clinical evaluation of indications and contraindications of vaccines; and (iii) Recognition and treatment of emergency reactions to vaccines; and (b) Possession of an active certification in basic cardiopulmonary resuscitation (CPR) obtained through in-person classroom instruction. (3) A registered pharmacy technician may not administer a vaccine as a delegated pharmacy act until the registered pharmacy technician receives written confirmation from the Board accepting the notification form. (4) The delegating supervising pharmacist shall confirm that a registered pharmacy technician has met the requirements set forth in §B(2) and (3) of this regulation before delegating the administration of a vaccine to the registered pharmacy technician. (5) A pharmacy technician trainee may not administer a vaccine. C. A pharmacy technician shall be clearly identified as such to the public; D. When performing tasks in the prescription area, a pharmacy technician shall maintain proper: (1) Sanitation; (2) Hygiene; (3) Biohazard precautions; and (4) Infection control. E. Off-Site Data Entry. (1) Except as provided in §E(2) of this regulation, a registered pharmacy technician shall perform delegated pharmacy acts under the direct supervision of a licensed pharmacist. (2) A registered pharmacy technician may perform prescription data entry at a remote location outside of a licensed pharmacy provided that: (a) The registered pharmacy technician has immediate electronic access to a supervising pharmacist who can assist as needed; (b) The data entry is not required to be performed by a pharmacist; (c) The data entry is appropriate to the education, training, and experience of the registered pharmacy technician and supervising pharmacist; and (d) If the data entry involves access to protected patient information under the Health Insurance Portability and Accountability Act (HIPAA), it can be performed in a manner that maintains the confidentiality of patient information. #### Regulation .04 Validated Pharmacy Technician. *COMAR 10.34.34.04* A. Validated Pharmacy Technician — Minimum Requirements. (1) Experience. Prior to working as a validated pharmacy technician, an individual shall have a minimum of 1 year of experience as a registered pharmacy technician in the State. (2) Training. In addition to the requirements for pharmacy technician registration, to act as a validated pharmacy technician, an individual shall possess an active product verification certificate issued by a Board-approved national pharmacy technician certification program. B. Validated Pharmacy Technician — Final Product Verification. A pharmacist may delegate responsibility to perform the final verification of a prescription device, drug product, or medication order to a validated pharmacy technician under the following circumstances: (1) Prescription or Medication Order. (a) A pharmacist shall verify the data entry of the prescription device, drug product, or medication order in the pharmacy management system or, if applicable, the electronic health record for: (i) Accuracy; (ii) Appropriateness of the device, drug product, or medication; (iii) Appropriateness of the dosage form; (iv) Directions for use; (v) Labeling; (vi) Packaging; and (vii) Any other determination that requires the application of clinical expertise. (b) Bar code scanning or similar technology is utilized during the filling process and at the verification step to validate device, drug product, or medication selection accuracy. (c) The product being verified is packaged in unit-dose or unit-of-use packaging. (2) Stocking or Replenishing a Medication Distribution System. Notwithstanding any other regulation, a validated pharmacy technician may perform the final product verification of a prescription device, drug product, or medication selected for stocking into a medication distribution system provided that: (a) The medication distribution system utilizes bar code scanning or other similar technology to validate the device, drug product, or medication selection; and (b) The pharmacy responsible for the medication distribution system maintains and reviews annually a quality assurance policy which includes routine audits of the system to ensure the accuracy of stocked prescriptions. (3) A validated pharmacy technician may not perform the final product verification of a prescription device, drug product, or medication that the technician personally prepared. C. Validated Pharmacy Technician — Pharmacy Permit Holder’s Responsibilities. A pharmacy utilizing a validated pharmacy technician shall maintain records for a minimum of 2 years, and have those records readily available to the Board upon request, including: (1) A current list of all validated pharmacy technicians; (2) A job description for each validated pharmacy technician; and (3) Policies and standard operating procedures for validated pharmacy technicians. D. Validated Pharmacy Technician – Pharmacist’s Responsibilities. (1) A pharmacist may not delegate the final product verification of a compounded medication under any circumstance. (2) Notwithstanding any delegation of a pharmacy act to a validated pharmacy technician, a pharmacist shall maintain professional responsibility for every medication or prescription dispensed, and for each medication or prescription stocked into a medication distribution system under the supervision of the pharmacist. #### Regulation .05 Registration Requirements. *COMAR 10.34.34.05* A. An applicant currently certified by a national pharmacy technician certification program shall: (1) Submit to the Board a signed completed application on a form provided by the Board; (2) Submit to the Board evidence of current certification by a national pharmacy certification program; (3) Pay a fee as set forth in COMAR 10.34.09; and (4) Submit a request for a State Criminal History Records check. B. An applicant that does not qualify under §A of this regulation shall: (1) Submit to the Board a signed completed application on a form provided by the Board; (2) Be 17 years old or older; (3) Meet the following educational requirements: (a) Be a high school graduate or have attained a high school equivalency diploma; (b) Be enrolled and in good standing at a high school; or (c) Meet the requirements of §C of this regulation; (4) Provide satisfactory proof to the Board of the applicant's successful completion of a pharmacy technician training program approved by the Board that: (a) Is no longer than 6 months duration; and (b) Includes 160 hours of work experience; (5) Pass an examination approved by the Board as set forth in Regulation .06 of this chapter; (6) Pay a fee as set forth in COMAR 10.34.09; and (7) Submit a request for a State Criminal History Records check. C. An applicant who does not meet the requirements of §A or B of this regulation shall: (1) Submit to the Board a signed application on a form provided by the Board; (2) Comply with the age requirements as set forth in §B of this regulation; (3) Provide written verification from the pharmacy permit holder that the applicant has worked in the pharmacy area of a pharmacy operated by the same pharmacy permit holder continuously since January 1, 2006; (4) Provide written verification from the pharmacist who has supervised the applicant for at least 6 months that the applicant has performed competently; (5) Pay a fee as set forth in COMAR 10.34.09; and (6) Submit a request for a State Criminal History Records check. D. The Board of Pharmacy shall provide the pharmacy technician with a registration card and pocket identification card upon initial registration and renewal. #### Regulation .06 Pharmacy Students —Exemptions. *COMAR 10.34.34.06* A. Pharmacy students who are practicing in a pharmacy as part of a school of pharmacy sanctioned experiential learning rotation are not subject to the registration requirements of Regulation .04 of this chapter. B. Pharmacy students who are currently completing the first year of a professional pharmacy education program and are not in a school of pharmacy sanctioned experiential learning rotation may perform delegated pharmacy acts provided that the pharmacy student: (1) Submits to the Board a signed completed application for exemption from the registration requirements of Regulation .04 of this chapter; and (2) Provides verification of enrollment and good standing at an accredited school of pharmacy. C. A pharmacy student may begin work under this exemption upon compliance with §B of this regulation. D. An exemption from registration granted under this regulation is effective only during the first year of the pharmacy students professional pharmacy education program. E. Pharmacy students granted an exemption from registration under this regulation are not subject to renewal requirements as set forth in Regulation .08 of this chapter. F. A pharmacy student granted an exemption from registration under this regulation shall perform delegated pharmacy acts under the direct supervision of a licensed pharmacist and in accordance with Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter. #### Regulation .07 Standards for Pharmacy Technician Training Programs. *COMAR 10.34.34.07* A. Minimum Standards. (1) Pharmacy technician training programs shall, at a minimum, cover the following areas of pharmacy practice: (a) Roles and responsibilities of the pharmacy technician; (b) Knowledge of prescription medications; (c) Knowledge of strengths or dose, dosage forms, physical appearance, routes of administration, and duration of drug therapy; (d) The dispensing process; (e) Pharmaceutical calculations; (f) Interacting with patients; (g) Third party prescriptions; (h) Extemporaneous compounding; (i) Requirements and professional standards for: (i) Preparing; (ii) Labeling; (iii) Dispensing; (iv) Storing; (v) Prepackaging; (vi) Distributing; and (vii) How medications are administered; (j) Confidentiality; (k) Drugs used to treat the following indications: (i) Hypertension; (ii) Antihyperlipidemia; (iii) Diabetes mellitus; (iv) Arthritis; (v) Gastrointestinal disorders; (vi) Asthma and allergy; and (vii) Infectious diseases; (l) Federal and State laws and regulations governing the practice of pharmacy; and (m) Knowledge of special dosing considerations for pediatric and geriatric populations. (2) Pharmacy technician training programs may be offered by: (a) Pharmacy employers; (b) Nationally recognized pharmacy technician training programs; (c) Accredited educational institutions pharmacy technician programs; (d) Pharmacy technician programs approved by the Maryland State Department of Education and the Maryland Higher Education Commission; and (e) Pharmacy technician training programs offered by the U.S. Armed Forces. (3) Training programs may not be longer than 6 months. (4) Training programs shall include 160 hours of work experience, which shall be completed within 6 months of the date of the pharmacy technician trainee’s enrollment in the program. B. Board Approval of Pharmacy Technician Training Programs. (1) A program shall submit an application on a form provided by the Board. (2) A program shall provide the Board with the course outline and any other information requested by the Board. (3) A pharmacy that pairs 160 hours of on-site work experience with a pharmacy technician training program that is Board-approved for its didactic content only shall obtain independent Board approval as a pharmacy technician training program prior to the delegation of any pharmacy act to a pharmacy technician trainee. (4) Any changes in course content shall require notification and approval from the Board. (5) The Board shall have final approval of a pharmacy technician training program. (6) The Board may withdraw approval of a program if the Board finds that the program is in violation of this chapter. (7) The Board shall approve pharmacy technician training programs offered by the U.S. Armed Forces. #### Regulation .08 Standards for Examination Approval. *COMAR 10.34.34.08* The Board shall approve examinations which have: A. Content criteria set forth in Regulation .06 of this chapter; B. A minimum of 100 multiple choice questions; C. Sufficient additional questions so that the examination questions may be rotated twice a year; and D. A passing score of 75 percent or higher. #### Regulation .09 Renewal Requirements. *COMAR 10.34.34.09* A. The pharmacy technician's registration shall expire on the last day of the birth month following 1 year after initial registration. B. Following initial registration, a pharmacy technician's registration: (1) Expires on the date set by the Board unless it is renewed for an additional term; and (2) May not be renewed for a term longer than 2 years. C. At least 1 month before the registration expires, the Board shall issue a renewal notice to the pharmacy technician registrant that states: (1) The date on which the current registration expires; (2) The date by which the renewal application shall be received by the Board for the renewal to be issued and mailed before the registration expires; and (3) The amount of the renewal fee. D. The registrant may renew the registration for an additional term of 2 years if the registrant: (1) Otherwise is entitled to be registered; (2) Pays to the Board a renewal fee set forth in COMAR 10.34.09; and (3) Submits to the Board: (a) A renewal application on the form that the Board requires; and (b) Satisfactory evidence of compliance with the continuing education requirements set forth in Regulation .09 of this chapter. #### Regulation .10 Continuing Education. *COMAR 10.34.34.10* A. Requirements. (1) A pharmacy technician registered to practice in Maryland shall: (a) Earn 20 hours of approved continuing pharmaceutical education within the 2-year period immediately preceding the registrant’s renewal application; and (b) If the registrant administers a vaccine in accordance with Regulation .03 of this chapter, earn 2 hours of continuing pharmaceutical education focused on vaccination as part of the 20 hours of continuing pharmaceutical education required for renewal. (2) For the first renewal period during which continuing education is mandatory for a pharmacy technician, the Board of Pharmacy shall require only 10 hours of continuing education requirements. (3) A pharmacy technician shall: (a) Attest to the fact that the pharmacy technician has completed the continuing pharmacy technician education requirement on the required form; and (b) Retain supporting documents for inspection by the Board for 4 years after the date of renewal for which the continuing education credits were used. B. Accredited Continuing Education Providers. (1) The following providers are approved for any programs they offer which otherwise qualify for continuing education credit: (a) Accreditation Council on Pharmaceutical Education (ACPE); (b) All schools of pharmacy accredited by the American Association of Colleges of Pharmacy (AACP); and (c) Out-of-State providers approved by a state board of pharmacy. (2) Procedures for Approval of Additional Programs. (a) Other providers shall initially request Board approval for individual programs. (b) An approved program is valid for a 2-year period. (c) The approved provider shall submit to the Board changes to the program that differ from the initial submission of information for Board approval. (d) Failure to submit to the Board changes to an approved program may result in the Board withdrawing approval of the program. (3) Providers of continuing education shall furnish a certificate of completion to participants who qualify that includes the: (a) Name of the participant; (b) Name of the provider; (c) Description of course work; (d) Number of hours; (e) Date of completion; and (f) Program identification number or provider number on the certificate. C. Miscellaneous. (1) Credits may not be carried over from one continuing education period to another. (2) The Board of Pharmacy may grant an exception from the continuing education requirements if the pharmacy technician presents evidence that failure to comply was due to circumstances beyond the pharmacy technician's control. (3) Falsifying continuing education records is grounds for disciplinary action under Health Occupations Article, §12-6B-09(2) and (3), Annotated Code of Maryland. (4) If the Board provides a form for information, the pharmacy technician shall use the form to supply the requested information to the Board. #### Regulation .11 Reinstatement. *COMAR 10.34.34.11* A. A pharmacy technician whose Maryland registration expired less than 2 years before applying for reinstatement shall: (1) Complete 20 hours of continuing education; and (2) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09. B. A pharmacy technician whose Maryland registration expired more than 2 years before applying for reinstatement, shall: (1) Complete 20 hours of continuing education; (2) Pay to the Board the reinstatement fee established by the Board in COMAR 10.34.09; and (3) Pass a Board-approved exam. #### Regulation .12 Reciprocity. *COMAR 10.34.34.12* A. An individual applying to register as a pharmacy technician by reciprocity shall: (1) Submit to the Board an application on a form approved by the Board; (2) Pay to the Board the fee set forth in COMAR 10.34.09; and (3) Submit a request for a State Criminal History Records check. B. An individual applying to register as a pharmacy technician by reciprocity shall: (1) Submit to the Board evidence of the following: (a) Registration in another state under requirements similar to the registration requirements of this chapter; and (b) Evidence of being in good standing in the state or states of current registration; or (2) Evidence of having worked as a pharmacy technician in another state for at least 6 months. ### Chapter 35 — Infusion Pharmacy Services in an Alternate Site Care Environment **Authority:** Health-Occupations Article, §12-205, Annotated Code of Maryland **Administrative History:** Effective date: March 1, 2012 (38:23 Md. R. 1421) #### Regulation .01 Definitions. *COMAR 10.34.35.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Alternate site care environment” means the location where the patient is receiving infusion therapy other than an inpatient hospital setting. (2) “Compounding worksheet” means a document or electronic record which: (a) Specifies instructions for a specific compounded parenteral medication; (b) Documents the manufacturer’s: (i) Ingredients; (ii) Lot numbers; and (iii) Expiration dates; and (c) Includes a copy of the prescription label. (3) Delegated Pharmacy Act. (a) “Delegated pharmacy act” means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter. (b) “Delegated pharmacy act” does not include: (i) An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Title 12, Subtitle 6A, Annotated Code of Maryland; (ii) The administration of an influenza vaccination in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland, or Health Occupations Article, Title 12, Annotated Code of Maryland; (iii) The delegation of a pharmacy act by a pharmacy technician, pharmacy student, or pharmacy technician trainee; (iv) A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, §12-301(b), Annotated Code of Maryland; (v) A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months; or (vi) The performance of other functions prohibited in regulations adopted by the Board. (4) “End of therapy” means the conclusion of parenteral infusion therapy as ordered by the prescriber. (5) “Infusion nurse” means a registered nurse providing infusion therapy as defined in COMAR 10.27.20.02B in an alternate site environment. (6) “Infusion pharmacy” means a pharmacy that provides pharmaceutical care to patients receiving parenteral therapy in an alternate site care environment. (7) “Licensed authorized prescriber of record” means an individual with the authority to prescribe and monitor a patient’s parenteral infusion therapy for the duration of the patient’s infusion therapy. (8) “Parenteral infusion access device” means, but is not limited to, intravenous, subcutaneous, intrathecal, epidural, or peripheral nerve catheter device through which parenteral medications may be administered. (9) “Patient care plan” means an individualized care plan that reflects the patient’s parenteral infusion therapy pharmaceutical monitoring plan aimed at optimizing the outcome of therapy while minimizing untoward effects from the medication. (10) “Patient triage form” means a written or electronic tool used by a clinician or by a registered pharmacy technician when communicating with a patient, a patient’s caregiver, or an infusion nurse to document the patient’s current status, including but not limited to, the patient’s response to therapy, medication changes or adverse reactions, and pain level. (11) “Permit holder” means a person, corporation, or other legal entity authorized by the Board to establish and operate a pharmacy. (12) “Pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts. (13) “Pharmacist” means an individual who is licensed to practice pharmacy. (14) “Supervision” means the on-site provision of management, direction, oversight and review of tasks assigned to personnel. #### Regulation .02 Permit Holder Responsibilities. *COMAR 10.34.35.02* The permit holder shall: A. Develop and maintain a policy and procedure manual which establishes the pharmacy’s policies and standard operating procedures related to the provision of infusion therapy services; B. Ensure that an annual review of the policy and procedure manual is performed by a qualified clinician or clinicians to assure that the policies and procedures meet the current standards of practice and regulatory requirements; C. Ensure that there is a process to verify the name, address, and contact information of the licensed authorized prescriber of record before initiation of therapy; D. Establish and maintain a training program which includes, but is not limited to, the requirements set forth in Regulation .07 of this chapter; E. If the infusion pharmacy is performing sterile compounding, ensure compliance with COMAR 10.34.19; F. If the infusion pharmacy outsources sterile compounding to another pharmacy, confirm that the secondary pharmacy is appropriately licensed and in compliance with COMAR 10.34.04 and COMAR 10.34.19; G. Assign a supervising pharmacist to provide oversight of the facility and operations as specified in Regulation .03 of this chapter; H. Ensure adequate supervision to unlicensed personnel; I. Limit access to the infusion pharmacy area to authorized personnel; J. Secure the facility and patient records in compliance with federal and State laws and regulations; and K. Develop and implement a written performance improvement program as set forth in Regulation .08 of this chapter. #### Regulation .03 Supervising Pharmacist Responsibilities. *COMAR 10.34.35.03* The supervising pharmacist or the supervising pharmacist's designee shall ensure compliance with: A. State and federal regulations; B. Infusion pharmacy practice standards: (1) As set forth in this chapter; and (2) As established by nationally recognized professional organizations and accrediting bodies as appropriate; C. The infusion pharmacy’s policies and procedures manual; D. An established training program; and E. An established performance improvement program. #### Regulation .04 Pharmacist Responsibilities. *COMAR 10.34.35.04* A. A pharmacist in an infusion pharmacy shall adhere to the policies and procedures set forth in Regulation .06 of this chapter. B. A pharmacist shall: (1) Provide infusion therapy services in accordance with: (a) Orders issued by a licensed authorized prescriber of record; and (b) Where applicable, protocols issued by a licensed authorized prescriber of record. (2) Perform and document initial and ongoing assessments of the appropriateness of infusion therapy using the following information: (a) Patient demographics including: (i) Name; (ii) Address; (iii) Telephone number; (iv) Gender; and (v) Date of birth; (b) Emergency contact information; (c) Diagnoses, including: (i) Diagnosis being treated; and (ii) Concurrent conditions, including pregnancy and lactation status if applicable; (d) Medical history; (e) Allergies; (f) If applicable, height; (g) Weight; (h) Parenteral medication orders, including length of therapy; (i) Parenteral infusion access device: (i) Location; (ii) Type; and (iii) If available, date of placement; (j) Ongoing medication profile review and reconciliation at end of therapy; (k) First dose status; (l) Caregiver information including, but not limited to: (i) Name; (ii) Address; (iii) Phone number; and (iv) Relationship to patient; (m) If applicable, contact information for other agencies or individuals involved in the patient’s home care; (n) Documented applicable medical and social factors and functional limitations which may affect infusion therapy including but not limited to: (i) Language; (ii) Sight; (iii) Hearing; (iv) History of IV drug abuse; (v) History of drug or alcohol abuse; or (vi) Other physical or mental limitations; and (o) If applicable to therapy, baseline labs; (3) Create a patient care plan specific to the patient’s: (a) Diagnosis; (b) Prescribed therapy; and (c) Concurrent conditions; (4) When compounding sterile preparations, comply with COMAR 10.34.19; (5) If sterile compounding is outsourced, comply with COMAR 10.34.04; (6) As applicable, retrieve and assess lab values and other monitoring parameters; (7) Document in the patient chart: (a) New prescription orders; (b) Changes in prescription orders; (c) Information obtained from the patient or caregiver; and (d) Other necessary information obtained from the: (i) Patient; (ii) Caregiver; (iii) Infusion nurse; (iv) Licensed authorized prescriber of record; or (v) Other sources relevant to patient care; (8) Verify prescription label accuracy; (9) Communicate as appropriate, throughout the patient’s therapy with the: (a) Licensed authorized prescriber of record or agent of the licensed authorized prescriber of record; (b) Patient’s infusion nurse; (c) Patient; and (d) Caregiver; and (10) Review therapy-specific considerations such as pain and nutrition status. #### Regulation .05 Support Personnel. *COMAR 10.34.35.05* A. Pharmacy Technicians. (1) A pharmacist working in an infusion pharmacy may delegate pharmacy acts to a pharmacy technician in accordance with COMAR 10.34.34. (2) A pharmacy technician working in an infusion pharmacy may not perform delegated pharmacy acts as set forth in COMAR 10.34.34.03. (3) A pharmacy technician working in an infusion pharmacy shall: (a) Communicate immediately to the pharmacist reported changes in: (i) Patient condition; (ii) Patient medication list; and (iii) Allergies; and (b) Obtain pharmacist approval before processing refills. (4) A pharmacy technician working in an infusion pharmacy may not: (a) Except as provided in COMAR 10.34.34, accept or transcribe a new or change verbal order from an licensed authorized prescriber of record or the licensed authorized prescriber of record’s agent; (b) Perform the clinical assessment of a patient; (c) Communicate clinical matters except as required in §A(3)(a) of this regulations; (d) Provide therapy-related direction to a patient or caregiver; and (e) Create a patient care plan specific to a patient’s therapy. B. Unlicensed Personnel. (1) Unlicensed personnel working in an infusion pharmacy under the supervision of a pharmacist may perform operational support which the unlicensed personnel have been trained to adequately perform in accordance with COMAR 10.34.21. (2) Unlicensed personnel shall be appropriately trained to perform the following tasks, as applicable, including but not limited to: (a) Schedule delivery dates based on; (i) Patient supply needs; (ii) Patient or caregiver availability; and (iii) If applicable, geographic delivery zones; (b) Create delivery tickets; (c) Communicate with the infusion nurse or pharmacist concerning supply needs and problems; and (d) Clean, test, and maintain patient-use equipment. (3) Unlicensed personnel working in an infusion pharmacy shall refer clinical questions or concerns reported by patients or caregivers immediately to the pharmacist. (4) Unlicensed personnel may not perform delegated pharmacy acts. #### Regulation .06 Minimum Requirements for Policies and Procedures. *COMAR 10.34.35.06* The policies and procedures shall: A. Be congruent with State regulations and standards of care from accrediting bodies and professional organizations; and B. Address: (1) Personnel: (a) Training and Orientation; (b) Duties; and (c) Qualifications; (2) Security of the facility; (3) Standards of patient care; (4) Infection control; (5) Initial and ongoing home safety assessments; (6) The provision of patient or caregiver education including, but not limited to: (a) Drug and therapy administration-specific information and precautions; (b) Reporting adverse drug reactions; (c) Reporting side effects; (d) Infusion pharmacy contact information; (e) Emergency measures related to: (i) Changes in patient condition requiring medical intervention; and (ii) Events which may delay or prevent delivery of pharmaceuticals or nursing care; and (f) Equipment use and safety. (7) Patient care operations, including but not limited to: (a) If applicable, pharmacist checking procedures related to order entry and compounding accuracy; (b) Therapy-specific monitoring parameters for: (i) Laboratory testing; (ii) Appropriate frequency of testing; and (iii) Patient follow-up; and (c) Pump, or other patient-use equipment, between-patient cleaning, testing, and preventive maintenance, which include specific: (i) Procedures and documentation of cleaning, testing and preventive maintenance for patient equipment according to manufacturer’s guidelines; and (ii) Frequencies for all equipment maintenance activities; (8) Delivery arrangements; (9) Patient confidentiality and the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164; and (10) Availability of a pharmacist on call after-hours to respond to: (a) Pharmacy related patient or caregiver inquiries; and (b) Medication or supply needs. #### Regulation .07 Training Requirements. *COMAR 10.34.35.07* A. Personnel shall be trained in the following areas where appropriate: (1) Patient rights and responsibilities; (2) Patient safety; (3) Performance improvement program; (4) Universal precautions which are incorporated by reference in COMAR 10.06.01.01-1; (5) Warehouse and equipment orientation; (6) Waste management; (7) Handling hazardous substances; (8) Policies and procedures; (9) Recognizing signs of patient abuse and neglect; (10) Recognizing signs of IV drug abuse; (11) Customer service and cultural sensitivity training; (12) Emergency policies and procedures which support the continuum of patient care during natural or manmade disasters; and (13) Patient confidentiality and the Health Insurance Portability and Accountability Act, 45 CFR Parts 160 and 164. B. A pharmacist shall be trained and evaluated in the following areas, including but not limited to: (1) Clinical management of therapies and disease states managed by the infusion pharmacy services, including but not limited to: (a) Specific dosing and monitoring protocols; (b) Care planning; (c) Lab value ranges; and (d) Side effects; (2) Pump use and programming; (3) Parenteral infusion access devices and therapy-specific appropriateness by device; (4) Supplies by therapy and device; (5) Accurate set-up of compounding worksheet instructions; (6) Pharmacist functions on computer systems; (7) Documentation; (8) If performing sterile compounding, COMAR 10.34.19; (9) Medication storage; (10) IV compatibility and stability; (11) Calculations to ensure: (a) IV dose appropriateness; and (b) Compounding accuracy, if applicable; and (12) On-call requirements and procedures for handling after-hours care. C. A pharmacy technician obtaining clinical information shall be trained and evaluated in the following areas, including but not limited to: (1) Pharmacy technician functions on computer systems; (2) Parenteral infusion access devices (3) Supplies specific to therapy and device (4) Storage and shipping protocols; (5) Pharmaceutical calculations for IV compounding, if applicable; (6) Patient triage forms — therapy-specific training and communication with the pharmacist as specified in Regulation .05A(3)(a) of this chapter; and (7) Documentation of: (a) Communication with patients or caregiver; and (b) Delivery scheduling. D. Unlicensed personnel shall be trained and evaluated in the following areas as applicable: (1) Insurance pre-authorization; (2) Billing; (3) Delivery procedures; (4) Supplies; (5) Picking and packing of supplies; (6) Drug storage; (7) Shipping protocols; and (8) Cleaning, testing, and maintenance of patient-use equipment according to manufacturers’ specifications. #### Regulation .08 Performance Improvement Program. *COMAR 10.34.35.08* A. The performance improvement program shall consist of: (1) A committee which: (a) Consists of representation of personnel and varied areas of job responsibility; and (b) Is responsible for analysis of data, reporting trends and corrective actions; and (c) Meets at least quarterly; (2) Quality assurance and performance improvement monitoring parameters; (3) Documentation requirements for: (a) Established monitoring parameters; (b) Trend analyses; and (c) Retention of committee meeting minutes for 3 years; (4) Documentation of tracking, trending, analyzing, resolving, and developing corrective action plans as appropriate for: (a) Medication errors; (b) Adverse drug reactions; and (c) Equipment malfunctions; (5) Reporting of adverse events to regulatory and standard-setting bodies as applicable to State and federal regulations; (6) Documentation and resolution of patient care issues involving: (a) Incorrect equipment, supplies, or medications; (b) Delays in delivery of care; (c) Missed doses; (d) Patient infections; (e) Failures in after-hours care; and (f) Patient, caregiver, or health care provider complaints; (7) Documentation of patient outcomes; (8) Recall management; (9) Patient compliance monitoring; and (10) Staff training and competency compliance. B. The permit holder shall review the performance improvement program at a minimum of every 3 years. #### Regulation .09 Discontinuation of Infusion Therapy. *COMAR 10.34.35.09* A. If not addressed in the initial order, the infusion pharmacy shall verify an end of therapy order. B. The infusion pharmacist shall: (1) Communicate with the licensed authorized prescriber of record or agent of the prescriber of record to verify: (a) An end of therapy order, if not addressed in the initial order; and (b) Parenteral infusion access device disposition, including orders for removal or line maintenance; and (2) Forward the most current medication list to: (a) The licensed authorized prescriber of record; and (b) To the patient or caregiver. C. If appropriate, the infusion pharmacy shall arrange with the patient or caregiver for pick-up of medical equipment. #### Regulation .10 Reference Materials. *COMAR 10.34.35.10* A. An infusion pharmacy shall maintain an adequate reference library to enable it to prepare and dispense infusion therapy properly. B. In addition to the requirements of COMAR 10.34.07.03, an infusion pharmacy’s reference library shall include: (1) Material Safety Data Sheets (MSDSs); (2) IV compatibility references; (3) Stability and extended stability references; (4) Websites and electronic references authored by established medical publishers recognized within the field of infusion pharmacy practice as a supplement to its printed library; (5) Pediatric dosing reference, if applicable; and (6) Appropriate clinical references for the population served. ### Chapter 36 — Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes **Authority:** Health-Occupations Article, §§12-205, 12-301, 12-401, 12-403, 12-501, and 12-503 — 12-506, Annotated Code of Maryland **Administrative History:** Effective date: June 15, 2013 (40:9 Md. R. 789) #### Regulation .01 Scope. *COMAR 10.34.36.01* This chapter applies to pharmacies and licensed pharmacists serving assisted living programs or group homes as defined in Regulation .02 of this chapter, except for pharmacies providing only emergency services for assisted living programs or group homes. #### Regulation .02 Definitions. *COMAR 10.34.36.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Assisted Living Program. (a) “Assisted living program” means a residential or facility-based program that provides housing and supportive services, supervision, personalized assistance, health-related services, or a combination of these services 24 hours a day, 7 days a week, to meet the needs of individuals who are unable to perform, or who need assistance in performing, the activities of daily living or instrumental activities of daily living, in a way that promotes optimum dignity and independence for the individuals. (b) “Assisted living program” does not include: (i) A nursing home or comprehensive care facility, as defined under Health-General Article, §19-301, Annotated Code of Maryland; (ii) A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland; (iii) A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland; (iv) A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland; (v) Services provided by family members; (vi) Services provided by a licensed residential service agency or licensed home health agency in an individual's own home; or (vii) A Certified Adult Residential Environment Program that is certified by the Department of Human Services under Article 88A, §140, Annotated Code of Maryland. (2) “Chart order” means a lawful order entered on the chart or a medical record of a resident of an assisted living program or group home by an authorized prescriber or the authorized prescriber’s designated agent for a drug or device. (3) “Group home” means a residence owned, leased, or operated by a licensed group home provider that: (a) Provides residential services for individuals who, because of a developmental disability, require specialized living arrangements; (b) Admits at least two, but not more than eight individuals; and (c) Provides 10 or more hours of supervision per week. (4) “Interim box” means a tamper evident container or an electronic system holding minimal quantities of medications: (a) Agreed upon by the appropriate committee of the assisted living program; and (b) Intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply. (5) “Licensed pharmacist” means a pharmacist who is licensed by the Board to practice pharmacy. (6) “Packaging” means the process by which a medication is: (a) Removed from a: (i) Non-patient specific manufacturer’s original container; or (ii) Patient specific container directly received from another pharmacy licensed in Maryland or operated by the government of the United States provided that the manufacturer’s name is present on the container; (b) Placed into a new container by a licensed pharmacist or registered pharmacy technician under the direct supervision of a pharmacist; and (c) Packaged as further defined in Regulation .07 of this chapter. (7) “Pharmaceutical services” means the care within practice standards, laws, regulations, and guidelines which is afforded by a licensed pharmacist to the residents of an assisted living program or group home. (8) “Pharmacy area” means that portion of the licensed pharmacy where over-the-counter medications and other products requiring a prescription by federal or State law are stored and where the prescriptions are compounded or prepared. (9) “Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts. (a) Licensed to engage in the practice of pharmacy in Maryland; (b) Knowledgeable in, and thoroughly familiar with, the specialized functions of an assisted living program's or group home's pharmaceutical services; and (c) Responsible for and in full and actual charge of the pharmacy and its personnel. (10) “Responsible pharmacist” means a pharmacist who is: (a) Licensed to engage in the practice of pharmacy in Maryland; (b) Knowledgeable in, and thoroughly familiar with, the specialized functions of an assisted living program’s or group home’s pharmaceutical services; and (c) Responsible for and in full and actual charge of the pharmacy and its personnel. (11) “Verbal order” means a directive that is orally communicated to a licensed pharmacist to accept a prescription order by a person who is authorized to communicate a prescription. (12) “Written order” means a directive that is directly written by an authorized prescriber or a transcription of an order from an authorized prescriber by a person authorized to transcribe an order. #### Regulation .03 Policies and Procedures. *COMAR 10.34.36.03* The permit holder shall establish and operate under a policies and procedures manual which: A. Complies with this chapter; B. Defines the scope and method of pharmacy services provided to the residents of the assisted living program or group home; C. Determines under what circumstances personnel may have access to the pharmacy area; D. Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle; E. Includes: (1) Labeling requirements and distribution methods for medication provided in a single container, slot, blister package, or other method of delivering an entire single dosing unit; and (2) The conditions in which an interim box may be replenished or prepared, delivered, and stored by the assisted living program; F. Is provided to: (1) The personnel of the pharmacy; (2) The assisted living program; (3) Group home; and (4) Upon request, an agent of the Board; and G. Is in a form that is: (1) Written or electronic; and (2) Readily retrievable. #### Regulation .04 Personnel. *COMAR 10.34.36.04* A. The permit holder shall appoint a responsible pharmacist who shall: (1) Be responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title; (2) Be responsible for reviewing the policies and procedures manual of the pharmacy annually and revising it as necessary; (3) Be responsible for the safe and efficient dispensing, delivery, and control of, and be accountable for, medications and devices dispensed or distributed by the pharmacy; (4) Work in cooperation with the other professional staff of the assisted living program or group home in meeting the responsibilities set forth in Regulation .06 of this chapter and in ordering, storing, and accounting for pharmaceutical materials; and (5) Develop a process for the pharmacy to be notified of medications which have been discontinued. B. Staff. (1) The permit holder: (a) May employ registered pharmacy technicians as required to provide pharmaceutical services to the residents of the assisted living program or group home; and (b) Shall provide policies and procedures that specify the duties that may be performed by registered pharmacy technicians under the supervision of a licensed pharmacist and the duties that may be performed only by a licensed pharmacist. (2) The permit holder may employ unlicensed personnel to provide operational support as defined in COMAR 10.34.21.02B. #### Regulation .05 Physical Requirements. *COMAR 10.34.36.05* A. Storage. The permit holder or designee shall ensure that medications and supplies within the pharmacy are properly stored according to the manufacturer’s specifications and State and federal laws and regulations with respect to: (1) Sanitation; (2) Temperature; (3) Light; (4) Ventilation; (5) Segregation; and (6) Security. B. Equipment and Materials. (1) The permit holder or designee shall ensure that the pharmacy contains as appropriate to the level of services provided: (a) Equipment; (b) Supplies; and (c) Physical facilities for proper compounding, preparation, and dispensing of medications as outlined in COMAR 10.34.19. (2) The permit holder or designee shall ensure that the pharmacy contains appropriate reference materials to enable personnel to prepare and dispense medications properly as outlined in COMAR 10.34.07. C. Security. (1) The permit holder or designee shall ensure that no individual enters the pharmacy area unless a licensed pharmacist is on duty. (2) The permit holder or designee shall ensure compliance with COMAR 10.34.05. #### Regulation .06 Medication and Device Distribution and Pharmaceutical Services. *COMAR 10.34.36.06* A. The responsible pharmacist shall be accountable for, at a minimum: (1) The preparation of medications compounded in the pharmacy as applicable; (2) The proper preparation, storage, and distribution of compounded sterile preparations according to COMAR 10.34.19 to the extent that the functions are performed at the pharmacy; (3) The packaging and labeling of medications; (4) Records of transactions of the pharmacy as may be required by applicable law and as may be necessary to maintain accurate control over and accountability for pharmaceuticals; B. In addition to §A of this regulation, the responsible pharmacist may: (1) Participate in those aspects of the assisted living program’s or group home’s quality assurance improvement program, if such program exists, which relate to pharmaceutical care and effectiveness; and (2) Implement the policies and decisions of the appropriate committee or committees of the assisted living program or group home related to these regulations and to other regulations of the assisted living program or group home. #### Regulation .07 Medication Packaging. *COMAR 10.34.36.07* A. A licensed pharmacist shall verify the: (1) Selection of medication to be packaged; and (2) Completed packaging of medication performed by registered pharmacy technicians for the following: (a) Accuracy; (b) Completeness; (c) Appropriateness; and (d) Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging. B. A licensed pharmacist shall ensure that labeling of the medication container includes the: (1) Brand or generic name of the medication; (2) Strength of the medication; (3) Name of the pharmacy; and (4) Expiration date of the medication. C. Unless a pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of: (1) 12 months from the date of packaging; (2) The manufacturer's or distributor's listed expiration date; or (3) The maximum time period allowed for the specific packaging used for the medication. D. Packaged from the Manufacturer’s Original Container. The pharmacy may use a lot number and expiration date assigned by the pharmacy instead of the distributor or manufacturer information in a master log if kept with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the: (1) Name of the drug; (2) Strength; (3) Manufacturer; (4) Lot number assigned by the pharmacy; (5) Lot number assigned by the distributor or manufacturer; (6) Quantity packaged; (7) Expiration date as defined in §C of this regulation; (8) Manufacturer's expiration date; (9) Date of packaging; (10) Name of pharmacy technician packaging; and (11) Name and initials of verifying licensed pharmacist. E. Packaged from Another Pharmacy. A licensed pharmacist may package medication received directly from another pharmacy licensed in Maryland or operated by the government of the United States provided that: (1) A licensed pharmacist determines that the medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the time it was dispensed by the original pharmacy and received by the packaging pharmacy; (2) A licensed pharmacist packages and dispenses all at one time the entire quantity of the prescription medications received from another pharmacy for packaging; (3) The manufacturer’s name is present on the container received from the other pharmacy; and (4) A licensed pharmacist maintains a master log that includes the following information: (a) Name of the drug; (b) Lot number assigned by the packaging pharmacy; (c) Strength; (d) Manufacturer; (e) Name, address, and telephone number of the original dispensing pharmacy; (f) Prescription number from the original dispensing pharmacy; (g) Quantity packaged; (h) Expiration date as assigned by the original dispensing pharmacy; (i) Date of packaging; (j) Name of pharmacy technician packaging; (k) Name and initials of verifying licensed pharmacist; and (l) Name of the resident. #### Regulation .08 Labeling of Resident Medications. *COMAR 10.34.36.08* A. A licensed pharmacist shall ensure that medications dispensed by the pharmacy and intended for use within an assisted living program or group home are dispensed in appropriate containers and are labeled with the: (1) Name and address of the pharmacy; (2) Date of dispensing; (3) Prescription number assigned by the pharmacy; (4) Name of the resident, patient, or consumer, as appropriate; (5) Name, quantity, and strength of the drug; (6) Name of the prescriber; (7) Expiration date of the drug; (8) Required precautionary information regarding controlled substances; (9) Directions for use as set forth in the: (a) Medication administration record; and (b) Prescriber’s orders; and (10) Further cautionary information as may be required or necessary for proper use of the medication. B. A licensed pharmacist shall ensure that medication provided per dosing period in a single container, slot, blister package, any other method of delivering an entire single dosing unit, or as part of a multi-dose dispensing package, are labeled with at least the following: (1) Drug name; (2) Drug strength; (3) Name of manufacturer; (4) Name of the resident, patient or consumer, as appropriate; (5) Lot number, unless prepared extemporaneously; (6) Directions for use as set forth in the: (a) Medication administration record; or (b) Prescriber’s orders; and (7) Expiration date. C. Compounded Sterile Preparations. When compounding sterile preparations a licensed pharmacist or a registered pharmacy technician under the licensed pharmacist’s supervision, shall comply with the compounding and labeling requirements of COMAR 10.34.19. #### Regulation .09 Drug Control and Accountability. *COMAR 10.34.36.09* A. Medications may be accepted for return if: (1) The returned medication is properly labeled and properly sealed in the manufacturer’s package or an individually labeled unit dose of a drug or a device; (2) A licensed pharmacist determines that procedures are in place that the returned medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy; and (3) The permit holder otherwise complies with COMAR 10.34.10.07. B. Discontinued Medications — Controlled Dangerous Substances. (1) Except as provided in §§B(2) and C(2) of this regulations, drugs classified as Schedule II, Schedule III, Schedule IV, and Schedule V may not be returned to the inventory of the pharmacy. (2) Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the resident. C. A compounded sterile preparation may not be returned to the inventory of a pharmacy. D. Drugs requiring refrigeration may not be returned to the inventory of a pharmacy. E. Interim Box. An interim box may be provided to an assisted living program by a permit holder if: (1) A licensed nurse is present on site 24 hours a day, 7 days a week; (2) The assisted living program is compliant with the pharmacy’s policies and procedures regarding usage of the interim box under Regulation .03 of this chapter; and (3) The contents of the interim box are part of the pharmacy inventory until administered. F. Prescriber Orders. (1) A licensed pharmacist shall dispense medications from the pharmacy only upon receipt of a valid written prescription, chart order, or verbal order from an authorized prescriber. (2) A chart order shall be considered a prescription drug order provided that the prescription drug order contains: (a) The full name of the resident, patient, or consumer, as appropriate; (b) The date of issuance; (c) The name, strength, and dosage form of the drug prescribed; (d) The name, type, and specifications of any device; (e) The directions for use; (f) If written, the authorized prescriber’s signature or the signature of the authorized prescriber’s agent (including the name of the authorized prescriber); (g) If electronically transmitted, prescription requirements as described in COMAR 10.34.20; and (h) If verbal, the name of the prescriber and the prescriber’s agent, if applicable. (3) A written order may be received by the pharmacy by facsimile, electronic transmission, or as the original physician order. (4) The licensed pharmacist shall document immediately a verbal order in writing. (5) A licensed pharmacist may receive a verbal order: (a) By telephone with the licensed pharmacist reading back the prescription to the prescriber or the prescriber’s agent; or (b) By a voice messaging system. G. Controlled Dangerous Substances. (1) Drug Accountability. The permit holder shall ensure that personnel employed by the pharmacy abide by the laws and regulations as defined in: (a) Health-General Article, Title 27, Annotated Code of Maryland; and (b) COMAR 10.19.03. (2) Storage and Security. The permit holder shall establish effective procedures for storage and security of Schedule II controlled dangerous substances including limitation of access to these drugs in the pharmacy to licensed pharmacists and registered pharmacy technicians. H. Drug Recalls. The licensed pharmacist shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are: (a) Returned to the pharmacy; (b) Sequestered; and (c) Handled as appropriate to the level of the recall. I. Adverse Drug Reactions. (1) The licensed pharmacist shall participate on the appropriate committee, if applicable of the assisted living program or group home, to establish procedures to report and record adverse drug reactions. (2) The licensed pharmacist shall ensure the procedures established include, at a minimum: (a) The reporting of significant adverse drug reactions to the attending prescriber or designee and other parties as specified by the appropriate committee of the assisted living program or group home; and (b) The recording in writing of an adverse reaction on the resident’s chart at the time it is reported. J. Records and Reports. The licensed pharmacist shall maintain records and reports as may be required by law, this chapter, and the policies of the assisted living program or group home. #### Regulation .10 Quality Management. *COMAR 10.34.36.10* A. The responsible pharmacist, in cooperation with the appropriate committee of the assisted living program, shall develop procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter and COMAR 10.07.14.29 where appropriate. B. The responsible pharmacist, in cooperation with the appropriate committee of the group home, if applicable, may develop procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter. ### Chapter 37 — Pharmacy Permit Holder Requirements — Wholesale Distribution and Nonresident Pharmacy Operations **Authority:** Health-Occupations Article, §§12-205, 12-403, and 12-406, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 2014 (41:10 Md. R. 561) **Administrative History:** Regulation .01 amended effective October 9, 2017 (44:20 Md. R. 945) **Administrative History:** Regulation .04 adopted effective October 9, 2017 (44:20 Md. R. 945) #### Regulation .01 Scope. *COMAR 10.34.37.01* This chapter establishes requirements for a pharmacy licensed by the Maryland Board of Pharmacy that: A. Engages in wholesale distribution; or B. Operates as a nonresident pharmacy. #### Regulation .02 Pharmacies Issued a Waiver Permit. *COMAR 10.34.37.02* A. A pharmacy that is issued a waiver permit by the Board under Health Occupations Article, §12–403(c), Annotated Code of Maryland, may engage in wholesale distribution, provided that: (1) The waiver pharmacy only engages in wholesale distribution with another pharmacy; and (2) The wholesale distribution business does not exceed 5 percent of the waiver pharmacy’s annual sales. B. Record Keeping Requirements. A waiver pharmacy that conducts wholesale distribution as set forth in §A of this regulation shall: (1) Maintain records of the waiver pharmacy’s wholesale distribution separately from its other records; and (2) Make records of wholesale distribution available for inspection by the Board. #### Regulation .03 Requirements for Wholesale Distribution. *COMAR 10.34.37.03* A. General Requirements. (1) A full service pharmacy may conduct wholesale distribution provided that the wholesale distribution business does not exceed 5 percent of the full service pharmacy’s annual sales. (2) A full service pharmacy may conduct wholesale distribution: (a) With another pharmacy; or (b) With a wholesale distributor, if the full service pharmacy reports to the Board within a week, on a form approved by the Board, of the full service pharmacy’s wholesale distribution to a wholesale distributor. B. Recordkeeping Requirements. A full service pharmacy that conducts wholesale distribution as set forth in §A of this regulation shall: (1) Maintain records of wholesale distribution separately from its other records; (2) Maintain records of wholesale distribution to wholesale distributors separately from its records of wholesale distribution to pharmacies; and (3) Make records of wholesale distribution available for inspection by the Board. #### Regulation .04 Requirements for Nonresident Pharmacy Operations. *COMAR 10.34.37.04* A. A Maryland licensed pharmacist may not be employed by more than one nonresident pharmacy at a time. B. A nonresident pharmacy shall: (1) Hold a pharmacy permit issued by the Board; (2) Have a pharmacist on staff who is: (a) Licensed by the Board; (b) Designated as the pharmacist responsible for providing pharmaceutical services to patients in the State; and (c) Regularly available on-site as needed to meet Maryland patient’s needs; (3) Designate another Maryland licensed pharmacist as the pharmacist on staff within 60 days upon the loss of the current designated pharmacist on staff; (4) Be located and equipped so that the pharmacy may be operated without endangering the public health or safety; (5) Maintain at all times a current reference library that is appropriate to meet the needs of: (a) The practice specialty of that pharmacy; and (b) The consumers the pharmacy serves; (6) Comply with the regulations adopted by the Board establishing the types of texts required to be included in the reference libraries in each of the various practice specialty pharmacies; (7) Maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary in a pharmacy to: (a) Prepare and dispense prescriptions properly; and (b) Otherwise operate a pharmacy; (8) Be equipped with the minimum equipment and appliances specified by the Board under this regulation; (9) Be kept in a clean and orderly manner; (10) Store all prescription or nonprescription drugs or devices properly and safely as set forth in COMAR 10.34.22.06; (11) On an annual basis and within 30 days after a change of office, corporate officer, or pharmacist, disclose to the Board the location, names, and titles of all principal corporate officers and all pharmacists who are dispensing prescriptions for drugs or devices to persons in this State; (12) Comply with all lawful directions and requests for information from the regulatory or licensing agency of the state in which it is located and all requests for information made by the Board pursuant to this regulation; (13) Maintain at all times a valid, unexpired permit to conduct a pharmacy in compliance with the laws of the state in which it is located; (14) Maintain records of prescription drugs or devices dispensed to patients in this State so that the records are readily retrievable; (15) During the pharmacy’s regular hours of operation, but not less than 6 days a week, and for a minimum of 40 hours per week, provide a toll-free telephone service to facilitate communication between patients in this State and a pharmacist or an individual who: (a) Has access to the patient’s prescription records; and (b) Is required to refer patients in the State to the responsible pharmacist licensed in the State, as appropriate; (16) Disclose the pharmacy’s toll-free telephone number on a label affixed to each container of drugs or devices; (17) Comply with the laws of this State relating to the confidentiality of prescription records if there are no laws relating to the confidentiality of prescription records in the state in which the nonresident pharmacy is located; (18) With regard to a prescription drug that is delivered in this State by the United States Postal Service, a common carrier, or a delivery service and is not personally hand delivered directly to a patient or to the agent of the patient at the residence of the patient or at another location designated by the patient: (a) Provide a general written notice in each shipment of a prescription drug that alerts a consumer that, under certain circumstances, a medication’s effectiveness may be affected by exposure to extremes of heat, cold, or humidity; and (b) Provide a specific written notice in each shipment of a prescription drug that provides a consumer with a toll-free or local consumer access telephone number accessible during regular hours of operation, which is designed to respond to consumer questions pertaining to medications; (19) Provide information regarding the process for resolving incorrectly filled prescriptions in accordance with existing regulations by: (a) Posting a sign that is conspicuously positioned and readable by consumers at the point where prescription drugs are dispensed to consumers; or (b) Including written information regarding the process with each prescription dispensed; and (20) If dispensing compounded sterile preparations to patients in the State, comply with: (a) USP standards; and (b) COMAR 10.34.19. C. A nonresident pharmacy may not: (1) Offer pharmaceutical services under any term or condition that tends to interfere with or impair the free and complete exercise of professional pharmaceutical judgment or skill; (2) Make any agreement that denies a patient a free choice of pharmacist or pharmacy services; (3) Participate in any activity that is a ground for Board action against: (a) A licensed pharmacist under Health Occupations Article, §12–313, Annotated Code of Maryland; (b) A registered pharmacy technician under Health Occupations Article, §12–6B–09, Annotated Code of Maryland; or (c) A registered pharmacy intern under Health Occupations Article, §12–6D–11, Annotated Code of Maryland; or (4) Allow an unauthorized individual to represent that the individual is a pharmacist, a registered pharmacy intern, or registered pharmacy technician. ### Chapter 38 — Pharmacy Interns **Authority:** Health-Occupations Article, §§12-205, 12-206, 12-301, 12-315 — 12-317, 12-319, 12-320, 12-505, 12-6D-01 — 12-6D-15, and 12-707, Annotated Code of Maryland **Administrative History:** Effective date: July 1, 2015 (42:7 Md. R. 569) #### Regulation .01 Scope. *COMAR 10.34.38.01* A. This chapter applies to applicants for registration as pharmacy interns and to registered pharmacy interns. B. This chapter does not apply to pharmacy students: (1) In a school of pharmacy sanctioned experiential learning program; or (2) Registered as pharmacy technicians with the Board performing delegated pharmacy acts. C. This chapter applies to individuals functioning as a pharmacy intern regardless of whether they are paid. #### Regulation .02 Definitions. *COMAR 10.34.38.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Direct supervision” means that a licensed pharmacist is physically available, notwithstanding appropriate breaks, on-site and in the prescription area or in an area where pharmacy services are provided to supervise the practice of pharmacy and delegated pharmacy acts. (3) “Pharmacy student” means an individual who is enrolled as a student in a school or college of pharmacy: (a) Accredited by the Accreditation Council for Pharmacy Education; or (b) Having precandidate or candidate status by the Accreditation Council for Pharmacy Education. (4) “Registered pharmacy intern” means an individual who is registered with the Board to practice pharmacy under the direct supervision of a pharmacist. (5) “Registration” means in this chapter, unless the context requires otherwise, a registration issued by the Board to practice pharmacy under the direct supervision of a licensed pharmacist. (6) “Supervision” means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual. #### Regulation .03 Prohibited Pharmacy Acts. *COMAR 10.34.38.03* A registered pharmacy intern may not: A. Delegate a pharmacy act; B. Perform a final verification of a prescription drug or device before dispensing; C. Perform any act that has not been authorized by the supervising pharmacist; D. Represent themselves as a pharmacist; E. Dispense prescription medications when the pharmacist is not in the pharmacy; F. Be present in the pharmacy when the pharmacist is not physically available onsite; G. Act within the parameters of a therapy management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland; H. Independently compound prescriptions; or I. Accept the return of prescription drugs or devices directly from a patient. #### Regulation .04 General Requirements. *COMAR 10.34.38.04* A. Each registered pharmacy intern shall: (1) Display the pharmacy intern’s registration in the office or place of business in which the pharmacy intern is practicing pharmacy under the direct supervision of a licensed pharmacist; or (2) Have the registration on the pharmacy intern’s person available for viewing. B. When practicing pharmacy under the direct supervision of a licensed pharmacist, the registered pharmacy intern shall wear identification that conspicuously identifies the registered pharmacy intern as a registered pharmacy intern. C. When performing tasks in the prescription area, a pharmacy intern shall maintain proper: (1) Sanitation; (2) Hygiene; (3) Biohazard precautions; and (4) Infection control. D. A pharmacy intern, who has obtained a registration as an actively enrolled student, shall immediately notify the Board if the pharmacy intern’s enrollment as a student has been revoked, suspended, terminated, or otherwise discontinued. #### Regulation .05 Limitation on Supervision. *COMAR 10.34.38.05* A licensed pharmacist may not directly supervise more than two registered pharmacy interns at one time. #### Regulation .06 Registration Requirements. *COMAR 10.34.38.06* A. An applicant shall be an individual who: (1) Is currently enrolled and has completed 1 year of professional pharmacy education in a doctor of pharmacy program: (a) Accredited by the Accreditation Council for Pharmacy Education; or (b) Having precandidate or candidate status by the Accreditation Council for Pharmacy Education; (2) Has graduated from a doctor of pharmacy program accredited by the Accreditation Council for Pharmacy Education; or (3) Is a graduate of a foreign school of pharmacy who: (a) Has established educational equivalency as approved by the Board; and (b) Has passed an examination of oral English approved by the Board. B. An applicant identified in §A of this regulation shall: (1) Submit to the Board a signed completed application on a form provided by the Board; (2) Pay a fee as set forth in COMAR 10.34.09; (3) Submit a request for a State Criminal History Records check; and (4) Be of good moral character. C. The Board may not approve an application until the State Criminal History Records Check is completed. D. The Board of Pharmacy shall provide the pharmacy intern with a registration card and pocket identification card upon initial registration and renewal. #### Regulation .07 Renewal Requirements. *COMAR 10.34.38.07* A. The pharmacy intern’s registration shall expire on the last day of the birth month following 1 year after initial registration. B. Except as provided in §C of this regulation, the Board shall send to each registrant, at least 1 month before a registration expires, a renewal notice by first–class mail to the last known address of the registrant. C. If requested by a registrant, the Board shall send to the registrant, at least two times within the month before a registration expires, a renewal notice by electronic means to the last known electronic address of the registrant. D. If a renewal notice sent by electronic means under §C of this regulation is returned to the Board as undeliverable, the Board shall send to the registrant a renewal notice by first-class mail to the last known address of the registrant. E. A renewal notice sent under this regulation shall state: (1) The date on which the current registration expires; (2) The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the registration expires; and (3) The amount of the renewal fee. F. A registered pharmacy intern who qualifies for registration under Regulation .06A(1) of this chapter may renew the registration one time if the registered pharmacy intern is: (1) Otherwise entitled to be registered as a pharmacy intern; (2) Submits to the Board a renewal application on the form that the Board requires; and (3) Pays to the Board a renewal fee set by the Board. G. A registered pharmacy intern who qualifies for registration under Regulation .06A(2) and (3) of this chapter may not renew the registration. H. The registration of a pharmacy intern registered under this chapter is void when the registered pharmacy intern becomes a licensed pharmacist. I. The Board shall renew the registration of each pharmacy intern who meets the requirements of this chapter. ### Chapter 39 — Pharmacist Administration of Self-Administered Drugs **Authority:** Health-Occupations Article, §§12-101, 12-102(b), and 12-509, Annotated Code of Maryland **Administrative History:** Effective date: May 9, 2016 (43:9 Md. R. 530) #### Regulation .01 Scope. *COMAR 10.34.39.01* This chapter does not limit or affect the right of an individual to practice a health occupation that the individual is authorized to practice. #### Regulation .02 Definitions. *COMAR 10.34.39.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Pharmacy. (2) “Pharmacist” means an individual who practices pharmacy regardless of the location where the activities of practice are performed. (3) “Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland. (4) “Pharmacy Experiential Program” means a program under the American Council on Pharmacy Education. (5) Practice Pharmacy. (a) “Practice pharmacy” means to engage in any of the following activities: (i) Providing pharmaceutical care; (ii) Compounding, dispensing, or distributing prescription drugs or devices; (iii) Compounding or dispensing nonprescription drugs or devices; (iv) Monitoring prescriptions and nonprescription drugs or devices; (v) Providing information, explanation, or recommendations to patients and health care practitioners about the safe and effective use of prescription or nonprescription drugs or devices; (vi) Identifying and appraising problems concerning the use or monitoring of therapy with drugs or devices; (vii) Acting within the parameters of a therapy management contract, as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland; or (viii) Administering vaccinations in accordance with Health Occupations Article, §12-508, Annotated Code of Maryland or self-administered drugs in accordance with Health Occupations Article, §12-509, Annotated Code of Maryland. (ix) Delegating a pharmacy act to a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program; (x) Supervising a delegated pharmacy act performed by a registered pharmacy technician, pharmacy student, or an individual engaged in a Board approved pharmacy technician training program; or (xi) Providing drug therapy management in accordance with Health-General Article, §19-713.6, Annotated Code of Maryland. (b) “Practice pharmacy” does not include the operations of a person who holds a permit issued under Health Occupations Article, §12-602, Annotated Code of Maryland. (6) “Registered pharmacy intern” means an individual who is registered with the Board to practice pharmacy under the direct supervision of a pharmacist. (7) Self-Administered Drug. (a) “Self-administered drug” means a drug that is regularly administered by the patient for whom the drug is prescribed or by an individual who is not otherwise authorized to administer drugs under Health Occupations Article, §12-509, Annotated Code of Maryland. (b) “Self–administered drug” includes: (i) Eye drops; (ii) A drug that is administered by an intramuscular injection or a subcutaneous injection; (iii) Ear drops; (iv) Inhalation therapies; (v) Intranasal therapies; and (vi) Topical therapies. #### Regulation .03 Requirements to Administer Self-Administered Drugs. *COMAR 10.34.39.03* A. A licensed pharmacist shall attest that the pharmacist has the appropriate training in administration of self-administered drugs that consists of instruction on: (1) Ear drops; (2) Eye drops; (3) Inhalation therapies; (4) Intramuscular injections; (5) Intranasal therapies; (6) Subcutaneous injections; and (7) Topical therapies. B. A licensed pharmacist shall possess an active certification in basic cardiopulmonary resuscitation obtained through in-person classroom instruction. C. A licensed pharmacist, certified under Health Occupations Article, §12-508, Annotated Code of Maryland, is deemed to have satisfied the training requirements in this chapter. D. A licensed pharmacist may administer a self-administered drug in accordance with a prescription. E. A pharmacy student in a Pharmacy Experiential Program or a registered pharmacy intern, may administer a self-administered drug under direct supervision of a licensed pharmacist who meets the requirements in §A or B of this regulation. #### Regulation .04 Record Keeping. *COMAR 10.34.39.04* A. The pharmacist shall document in the patient record the administration of a self-administered drug that includes the following information: (1) Name of the drug; (2) Dosage administered; (3) Site of administration; (4) Date and time of administration; and (5) Any instructions provided to the patient. B. The patient record shall be maintained for 5 years, unless otherwise required by law, and be: (1) Readily retrievable; and (2) Made available on the request of the Board. ### Chapter 40 — Pharmacists Prescribing Contraceptives **Authority:** Health-Occupations Article, §§12-101, 12-102(b), 12-205(a), and 12-511, Annotated Code of Maryland **Administrative History:** Effective date: July 2, 2018 (45:13 Md. R. 668) #### Regulation .01 Scope. *COMAR 10.34.40.01* This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice. #### Regulation .02 Definitions. *COMAR 10.34.40.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland Board of Pharmacy. (2) “Contraceptives” means contraceptive medications and self-administered contraceptive devices approved by the U.S. Food and Drug Administration. (3) “Pharmacist” means an individual who practices pharmacy under the Health Occupations Article, §12-101, Annotated Code of Maryland. (4) “Pharmacy” means an establishment holding a permit under Health Occupations Article, §12-401, Annotated Code of Maryland. (5) “Practicing pharmacy” has the same meaning stated in Health Occupations Article, §12-101(x), Annotated Code of Maryland. (6) “Primary care practitioner” means a licensed health care practitioner who: (a) Provides an individual’s primary care services; and (b) Is the primary coordinator of health care services for the individual. (7) “Reproductive health care practitioner” means a licensed health care practitioner who provides an individual’s reproductive health services. (8) “Visit summary” means: (a) A written record of either the contraceptives dispensed or a brief explanation as to why contraceptives were not prescribed; (b) Written information about the importance of seeing the patient’s primary care practitioner or reproductive health care practitioner to obtain recommended tests and screenings; and (c) A copy of the patient’s completed Self-Screening Risk Assessment Questionnaire. #### Regulation .03 Requirements to Prescribe Contraceptives. *COMAR 10.34.40.03* A. Board Responsibilities. The Board shall develop and adopt the following items, in consultation with stakeholders to be determined by the Board: (1) A self-screening risk assessment questionnaire that a patient shall complete before a pharmacist may prescribe contraceptives for a patient; (2) A standard procedure contraceptive algorithm which the pharmacist shall use to perform a patient assessment for purposes of determining: (a) Whether to prescribe contraceptives; and (b) Which contraceptive options to prescribe; (3) A notification form to be submitted by a pharmacist before prescribing contraceptives; and (4) Other forms and procedures for: (a) The prescription of contraceptives; and (b) Referral to a primary care or reproductive health care practitioner for treatment. B. Notification. (1) Except as provided in §B(2) of this regulation, at least 15 days before prescribing contraceptives, a pharmacist shall submit to the Board a notification form, which includes an attestation of completion of a Board-approved training program. (2) A pharmacist who has undergone training for prescribing contraceptives as part of the pharmacist’s formal educational program: (a) Is exempt from completing a Board-approved training program; and (b) At least 15 days before prescribing contraceptives, shall submit to the Board a notification form, which includes an attestation of the pharmacist’s formal education program. (3) A pharmacist may not prescribe contraceptives until the pharmacist receives a written confirmation from the Board accepting the pharmacist’s notification form. C. Pharmacist Responsibilities. (1) For each new patient requesting contraceptive services, and at a minimum of every 12 months for each returning patient, a participating pharmacist shall: (a) Obtain the completed Board-approved self-screening risk assessment questionnaire from the patient; and (b) Utilize and follow the Board-approved standard procedure contraceptive algorithm to: (i) Perform the patient assessment; (ii) Determine whether to prescribe contraceptives; and (iii) Determine which contraceptive options to prescribe. (2) Upon completion of all requirements established by the Board and after review of all relevant information, a pharmacist may prescribe contraceptives, if deemed clinically appropriate. (3) If contraceptives are prescribed, the pharmacist shall: (a) Refer the patient: (i) For additional care to their primary care practitioner or reproductive health care practitioner; or (ii) If the patient does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services; (b) Provide the patient with a visit summary; and (c) Document the encounter and maintain records pursuant to Regulation .05 of this chapter. (4) Upon completion of all requirements established by the Board and after review of all relevant information, if the pharmacist does not prescribe contraceptives, the pharmacist will provide a visit summary to the patient which provides the basis for the decision not to prescribe contraceptives. (5) A pharmacist may not prescribe contraceptives before January 1, 2019. #### Regulation .04 Training Program Requirements. *COMAR 10.34.40.04* At a minimum, a Board-approved training program shall contain the following elements: A. An overview of contraceptive medications and self-administered contraceptive devices; B. An overview of the self-screening risk assessment questionnaire; C. An overview of the standard procedure contraceptive algorithm; and D. An overview of the U.S. Medical Eligibility Criteria for Contraceptive Use and other Center for Disease Control guidance on contraception. #### Regulation .05 Record Keeping. *COMAR 10.34.40.05* For a minimum of 5 years, a pharmacy whose pharmacists prescribe contraceptives shall maintain documentation, in electronic or other form, which includes: A. The type of contraceptive prescribed, and dosage, if applicable, or the basis for not prescribing a contraceptive; B. The name, address, and date of birth of the patient; C. The name of the pharmacist who prescribed the contraceptive or determined a contraceptive would not be prescribed; D. The date the contraceptive was prescribed or that the patient was advised that a contraceptive would not be prescribed; E. A copy of the patient’s visit summary; F. A copy of the patient’s self screening risk assessment questionnaire; and G. The name and address of the: (1) Patient’s primary care practitioner or reproductive health care practitioner, if provided by the patient; or (2) Family planning provider or licensed clinician who provides reproductive health care services referred by the pharmacist, if the patient does not have a primary care practitioner or reproductive health care practitioner. #### Regulation .06 Continuing Education Requirement. *COMAR 10.34.40.06* A pharmacist who prescribes contraceptives in Maryland shall earn 1 hour of Board-approved continuing pharmaceutical education related to contraception before the pharmacist’s license renewal date. ### Chapter 41 — Administration of a Maintenance Injectable Medication **Authority:** Health-Occupations Article, §§12-101(o-1) and 12-509, Annotated Code of Maryland **Administrative History:** Effective date: June 13, 2022 (49:12 Md. R. 640) #### Regulation .01 Scope. *COMAR 10.34.41.01* This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice. #### Regulation .02 Definitions. *COMAR 10.34.41.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Authorized prescriber” means a practitioner licensed and authorized under Health Occupations Article, Annotated Code of Maryland, to prescribe prescription drugs. (2) “Board” means the Maryland Board of Pharmacy. (3) Maintenance Injectable Medication. (a) “Maintenance injectable medication” means a medication that: (i) Is administered by injection other than intravenously; (ii) Except as authorized for a self-administered drug pursuant to Health Occupations Article, §12-509, Annotated Code of Maryland, is not a biological product; and (iii) Treats a chronic need, condition, or disorder. (b) “Maintenance injectable medication” includes, but is not limited to, a medication for: (i) The treatment of a psychiatric disorder; (ii) The treatment of a substance use disorder; (iii) Contraception; and (iv) Vitamins. (4) “Pharmacist” means an individual who practices pharmacy under Health Occupations Article, §12-101, Annotated Code of Maryland. (5) “Practicing pharmacy” has the meaning stated in Health Occupations Article, §12-101(x), Annotated Code of Maryland. (6) “Primary care practitioner” means a licensed health care practitioner who provides an individual’s primary care services and is the primary coordinator of health care services for the individual. #### Regulation .03 Requirements to Administer a Maintenance Injectable Medication — Pharmacist’s Responsibilities. *COMAR 10.34.41.03* A. Upon completion of all requirements established by the Board in this chapter, and after review of all relevant information, a pharmacist may administer a maintenance injectable medication. B. In order to administer a maintenance injectable medication, a pharmacist shall: (1) Utilize and follow the Board-approved procedure set forth in Regulation .07 of this chapter to administer a maintenance injectable medication; (2) Refer a patient for additional care to the patient’s primary care practitioner or the authorized prescriber, if necessary; (3) Provide the patient and the authorized prescriber with a copy of the visit summary, including a written record of the maintenance injectable medication that was administered; (4) Document the encounter and maintain records pursuant to Regulation .05 of this chapter; and (5) Notify the authorized prescriber that the medication was administered to the specific patient and any relevant information about the patient’s condition. C. A pharmacist shall: (1) Obtain written approval from the patient’s authorized prescriber prior to administering an initial dose of a maintenance injectable medication; and (2) Notify the patient of all fees that the patient is required to pay before administering a maintenance injectable medication. #### Regulation .04 Training Program Requirements. *COMAR 10.34.41.04* A. Except as provided in §C of this regulation, a pharmacist shall successfully complete a Board-approved training program for the administration of injectable maintenance medications prior to administering injectable maintenance medications. B. At a minimum, a Board-approved training program consists of the following elements: (1) Administration of a maintenance injectable medication; (2) Management of the patient populations served by a pharmacist; (3) Knowledge of the specific maintenance injectable medications that a pharmacist may administer; and (4) Current guidelines relating to the specific patient populations served by a pharmacist and the specific maintenance injectable medications that a pharmacist may administer, if applicable. C. The training program requirement set forth in §A of this regulation is waived for a pharmacist who has undergone the training as part of a formal education program. D. A pharmacy student in a Pharmacy Experiential Program or a registered pharmacy intern, who has successfully completed a Board-approved certification course under Health Occupations Article, §12-508, Annotated Code of Maryland, may administer a maintenance injectable medication under the direct supervision of a licensed pharmacist who meets the requirements set forth in Regulation .03 of this chapter. #### Regulation .05 Record Keeping. *COMAR 10.34.41.05* A. A pharmacy that staffs a pharmacist that administers a maintenance injectable medication shall maintain the records of a minor patient, including the information listed in §B of this regulation, until the minor patient attains the age of majority plus 3 years or for 5 years after the record was made, whichever is later. B. For a minimum of 5 years, except for records related to minors, a pharmacy that staffs a pharmacist that administers a maintenance injectable medication shall maintain documentation, in electronic or other form, including: (1) The type and dose of maintenance injectable medication administered; (2) The name, address, and date of birth of the patient; (3) The name of the pharmacist who administered the maintenance injectable medication; (4) The date that the maintenance injectable medication was administered; (5) A copy of the patient’s visit summary, including any pertinent details about the patient’s condition; and (6) The name and address of the authorized prescriber of the maintenance injectable medication. C. A pharmacist who administers an injectable maintenance medication as an independent provider at a location that is not a pharmacy shall maintain records as required by §§A and B of this regulation. #### Regulation .06 Patient Information and Consent. *COMAR 10.34.41.06* A. A pharmacist that administers a maintenance injectable medication shall: (1) Obtain a paper or electronic consent form signed by the patient, or the patient’s legal guardian, that authorizes the pharmacist to administer the maintenance injectable medication; (2) Provide the patient, or the patient’s legal guardian, with a copy of the consent form for future reference upon request; (3) Provide the patient, or the patient’s legal guardian, and the authorized prescriber with a copy of the visit summary, including a written record of the maintenance injectable medication that was administered; and (4) Notify the patient of the need to attend any upcoming appointments the patient has scheduled with the prescriber for additional care. B. The administering pharmacist shall: (1) Disclose their credentials on the consent form; and (2) Provide every patient with notification of the fee for service prior to administration. #### Regulation .07 Standard Procedures. *COMAR 10.34.41.07* A. Before a pharmacist administers a maintenance injectable medication, a pharmacist shall have and maintain a written procedure for any maintenance injectable medication that may be administered. B. A pharmacist shall administer a maintenance injectable medication in accordance with the written procedure, including: (1) Recording and maintaining the prescription files in accordance with Regulation .05 of this chapter; (2) Reviewing and screening for the following: (a) Indications; (b) Precautions; (c) Contraindications; and (d) Allergies; (3) Reviewing the process for handling adverse reactions, including but not limited to: (a) Acute anaphylactic reactions; and (b) Other acute emergencies; (4) Following injection or administration procedures; (5) Advising the patient of post-administration procedures, including waiting requirements; and (6) Documenting and maintaining a maintenance injectable medication record, including: (a) Patient’s: (i) Name; (ii) Date of birth; (iii) Address; (iv) Consent form; (v) Authorized prescriber; and (vi) Administering pharmacist’s name and license number; (b) Administration: (i) Date; (ii) Dose; (iii) Site; and (iv) Route; (c) Maintenance injectable medication: (i) Name, generic or brand; (ii) Manufacturer; (iii) Lot number; and (iv) Expiration date; (d) Notification to the authorized prescriber that the patient received a specific maintenance injectable medication; and (e) Verification that the prescription is: (i) Not for the patient’s initial dose, if applicable; or (ii) For the patient’s initial dose and the patient’s record contains documented approval from the authorized prescriber. C. The pharmacist shall: (1) Sign and date the standard procedure at least annually; (2) Make the standard procedure available for inspection by the Board upon request; and (3) Review and update the standard procedure as necessary. ### Chapter 42 — Pharmacist Prescribing of a Nicotine Replacement Therapy Medication **Authority:** Health Occupations Article, §§12-205 and 12-514, Annotated Code of Maryland **Administrative History:** Effective date: October 14, 2024 (51:20 Md. R. 899) #### Regulation .01 Scope. *COMAR 10.34.42.01* This chapter does not limit or otherwise affect the right of an individual to practice pharmacy or any other health occupation that the individual is authorized to practice. #### Regulation .02 Definitions. *COMAR 10.34.42.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland Board of Pharmacy. (2) “Nicotine replacement therapy medication” means a nicotine-based treatment, including inhalers, gums, lozenges, nasal sprays, and patches, approved by the United States Food and Drug Administration that assists an individual to cease the use of products that contain nicotine. (3) “Primary care practitioner” means a licensed health care practitioner who: (a) Provides an individual’s primary care services; and (b) Is the primary coordinator of health care services for the individual. (4) “Visit summary” means: (a) A written record of the nicotine replacement therapy medication dispensed; (b) The name and contact information for the prescribing pharmacist; and (c) The information on the importance of regular appointments with the individual’s primary care practitioner. #### Regulation .03 Requirements to Prescribe and Dispense a Nicotine Replacement Therapy Medication. *COMAR 10.34.42.03* A. Training Requirements. (1) Prior to prescribing and dispensing a nicotine replacement therapy medication, a pharmacist shall complete a training program developed for the prescribing of a nicotine replacement therapy medication approved by the Board that is: (a) Offered by an accredited school of pharmacy; (b) Offered by an accredited school of medicine; or (c) Accredited by the Accreditation Council for Pharmacy Education. (2) A pharmacist who obtained training to prescribe a nicotine replacement therapy medication as part of their formal education is exempt from completing an additional training program. B. Standard Procedures. When an individual requests a nicotine replacement therapy medication, a pharmacist shall: (1) Provide the individual with appropriate counseling in the use of the prescribed nicotine replacement therapy medication; (2) Provide the individual with a visit summary; (3) Refer the patient to the individual’s primary care provider for additional care; and (4) Record the prescribing and dispensing of the nicotine replacement therapy medication in any health record maintained for the individual by the pharmacist. ### Chapter 43 — Prescription Labeling for Blind, Visually Impaired, and Print Disabled Individuals *Not yet effective* ## Subtitle 35 — Office of the Chief Medical Examiner ### Chapter 01 — Medical Examiner Cases **Authority:** Health-General Article, §§5-301 et seq., Estates and Trusts Article, §4-509; Annotated Code of Maryland **Administrative History:** Effective date: July 13, 1939 **Administrative History:** Amended December 22, 1950; February 27, 1951; May 15, 1951; June 26, 1951; January 15, 1963; October 22, 1963 **Administrative History:** Chapter revised effective August 2, 1993 (20:15 Md. R. 1220) **Administrative History:** Regulation .01B amended effective May 5, 2008 (35:9 Md. R. 898); November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .02 amended effective November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .03 amended effective May 5, 2008 (35:9 Md. R. 898); May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .06B, C amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .08B amended effective May 5, 2008 (35:9 Md. R. 898); November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .11 amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .12A, C amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation 13A, B amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .14 amended effective November 24, 2014 (41:23 Md. R. 1373); May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .14C amended effective May 5, 2008 (35:9 Md. R. 898) **Administrative History:** Regulation .14D amended effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulation .16 amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .18A, C amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .19A, B amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .19C, E amended effective November 24, 2014 (41:23 Md. R. 1373) **Administrative History:** Regulation .19E amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1275); amended permanently effective November 6, 2006 (33:22 Md. R. 1733) **Administrative History:** Regulation .19E amended effective December 31, 2018 (45:26 Md. R. 1246); May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .20E amended effective May 11, 2026 (53:9 Md. R. 414) **Administrative History:** Regulation .20F amended effective May 5, 1997 (24:9 Md. R. 657); November 24, 2014 (41:23 Md. R. 1373) **Administrative History:** Regulation .20F amended as an emergency provision effective July 1, 2006 (33:15 Md. R. 1275); amended permanently effective November 6, 2006 (33:22 Md. R. 1733) **Administrative History:** Regulation .20F amended effective May 5, 2008 (35:9 Md. R. 898); August 19, 2024 (51:16 Md. R. 742) **Administrative History:** Regulation .21 adopted effective November 24, 2014 (41:23 Md. R. 1373) #### Regulation .01 Definitions. *COMAR 10.35.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Autopsy report” means a written document detailing the medical findings and conclusions of a postmortem examination performed by a medical examiner. (2) “First degree relative” means a surviving spouse, parent, grandparent, sibling, and child of the deceased. (3) “Forensic investigator” means a chief forensic investigator, deputy chief forensic investigator, lead forensic investigator, or forensic investigator who: (a) Is employed under or appointed by the authority of the Maryland Department of Health; (b) Assists those medical examiners in §B(4)(a) of this regulation; (c) Has education, training, or experience in trauma or death investigation; and (d) Is appointed in accordance with Health-General Article, §5-306, Annotated Code of Maryland. (4) Medical Examiner. (a) “Medical examiner” means a Chief Medical Examiner, Deputy Chief Medical Examiner, or assistant medical examiner who is a pathologist authorized to carry out the provisions of Health-General Article, §5-308, Annotated Code of Maryland. (b) “Medical examiner” also means a deputy medical examiner who: (i) Assists those examiners in §B(4)(a) of this regulation; (ii) Is a physician; and (iii) Is appointed by the Maryland Department of Health in accordance with Health-General Article, §§5-305 and 5-306, Annotated Code of Maryland. (5) Medical Examiner Case. (a) “Medical examiner case” means any death which occurs as described in Health-General Article, §5-308(a), Annotated Code of Maryland. (b) “Medical examiner case” does not mean: (i) A stillbirth or a neonatal death, or accident room or hospital death in which the cause of death has been established by the hospital physician and is due to disease, and free of evidence of criminal or accidental nature; (ii) A case which is dead on arrival at the hospital and the physician who pronounces death has been in previous attendance on the patient; or (iii) A death which occurs in a hospital within 24 hours of admission merely because the death occurred within 24 hours. (6) “Procurement organization” has the meaning stated in Estates and Trusts Article, §4-501, Annotated Code of Maryland. (7) “Secretary” means the Secretary of Health. #### Regulation .02 Report of Medical Examiner Cases to the Police or Sheriff. *COMAR 10.35.01.02* A. Whenever a physician, funeral director, or other person has knowledge of a death that may fall under the jurisdiction of the Office of the Chief Medical Examiner in accordance with Health-General Article, §5-308(a), Annotated Code of Maryland, the physician, funeral director, or other person having this knowledge shall report it without delay to the police or sheriff law enforcement agency who has jurisdiction in the city or county where the death occurred. B. The medical examiner or forensic investigator may, in conjunction with law enforcement or under court authority, investigate any location believed to be associated with the death to gather essential facts to determine cause of death or manner of death. C. A health care facility may not refuse the medical examiner access to a body which is the subject of a medical examiner investigation at any time. #### Regulation .03 Medical Examiner. *COMAR 10.35.01.03* Any death in accordance with Health-General Article, §5-308(a), Annotated Code of Maryland, in the State shall be investigated and examined by the medical examiner in the Office of the Chief Medical Examiner in Baltimore, or in any other place as may be approved by the Chief Medical Examiner. #### Regulation .04 Deaths Due to Fire. *COMAR 10.35.01.04* A. Fire Fighters and State Fire Marshal Personnel. The medical examiner shall perform an autopsy and complete toxicological examination of any fire fighter or sworn personnel of the State Fire Marshal's Office who dies in the line of duty or whose death appears to have been caused by: (1) Fire; (2) Toxic gases; (3) Toxic fire conditions; or (4) Fire-related circumstances. B. Other Fire-Related Deaths. If a death occurs in a fire or is related to a fire, the medical examiner shall thoroughly investigate the circumstances of the death and report the death to the Center for the Study of the Health Effects of Fire in the Office of the Chief Medical Examiner for Maryland. #### Regulation .05 Completion of the Death Certificate. *COMAR 10.35.01.05* A. When the medical examiner has made a determination of the cause and manner of death, the medical examiner shall complete the death certificate. B. On the death certificate the medical examiner shall enter the: (1) Name of the deceased; (2) Cause of death and medical certification; (3) Date and hour of death; (4) Place where death occurred; and (5) Place where the body was found. C. The Medical Examiner shall record the manner of death under the section of the certificate designated as the medical certification. D. If the cause of death has not been established with reasonable medical certainty and further investigation is being conducted, the cause of death is left pending. E. If the cause of death has not been established with reasonable medical certainty, and the investigation has been completed, the certificate shall be completed to reflect that the cause of death was “undetermined”, and the manner of death was “undetermined”. #### Regulation .06 Establishing a Hospital Death as a Medical Examiner Case. *COMAR 10.35.01.06* A. The hospital physician shall be guided by the history and other circumstances in judging whether or not a death is under the jurisdiction of the medical examiner. B. Cases that do not fall under medical examiner jurisdiction may not be made such and will not be accepted simply because hospital autopsy permission has been refused or is not available. C. Cases that fall under medical examiner jurisdiction may not be autopsied by the hospital pathologist because consent for autopsy has been obtained in accordance with Health-General Article, §5-501, Annotated Code of Maryland. #### Regulation .07 Hospital Autopsy of Certain Medical Examiner Cases. *COMAR 10.35.01.07* A. The following types of medical examiner cases may be autopsied by the hospital pathologists with the authorization of the Chief Medical Examiner: (1) Death from acute or chronic alcoholism without manifestation of trauma; (2) Death from accidental burns occurring in the home; (3) Death, or sudden death, associated with a therapeutic procedure; (4) Death following a fracture in an elderly person and resulting from a simple fall in the home. B. In the cases listed in Sec. A of this regulation, permission from next of kin is not required since these are under the medical examiner's jurisdiction and the hospital pathologist is acting pursuant to this jurisdiction. C. The hospital agent shall complete the death certificate, and each death certificate shall be countersigned by the medical examiner. D. In non-medical-examiner cases, a hospital shall require proper autopsy permission in accordance with Maryland Autopsy Law, Health-General Article, § 5-501, Annotated Code of Maryland. #### Regulation .08 The Hospital Agent. *COMAR 10.35.01.08* A. Appointment. (1) Each hospital shall appoint a responsible agent, office, or individual with whom the medical examiner can communicate at any hour regarding medical examiner cases in the hospital, after receiving notification of them from the police authority. (2) Each hospital shall notify the medical examiner of the agent so appointed. B. Responsibilities. (1) Notification of Police. In accordance with Regulation .02 of this chapter, whenever a hospital in Maryland has a medical examiner case, the hospital agent shall report the case to the local law enforcement agency with jurisdiction in that subdivision of the State. The local law enforcement agency so notified shall transmit the information to the medical examiner’s investigator on duty. (2) A health care facility may not refuse the medical examiner access to a body which is the subject of a medical examiner’s case at any time. In order to prevent destruction or alteration of evidence, once death is determined, the hospital shall follow medical examiner guidance as to management of the body of the deceased. The medical examiner shall respond to the location of the body, investigate the case, and arrange for transportation of the body. (3) Preliminary Hospital Reports. The hospital agent designated in accordance with Regulation .08 of this chapter shall submit promptly to the medical examiner, for each medical examiner case, the following information: (a) The name and age, if known, of each decedent; (b) The date and time of admission; (c) Time of death; (d) Diagnosis, if made; (e) Place, date, time, and manner of accident, or violence, if any, and other information that the Medical Examiner may request; (f) Next-of-Kin, if known, as an attempt of a reasonable search effort; and (g) If any evidence is recovered during therapeutic intervention, the Office of the Chief Medical Examiner shall be notified. (4) Medical Examiner Requests. The hospital agent shall promptly respond to a medical examiner request for records and specimens. Failure to provide requested information within 24 hours will result in a report to the Office of Health Care Quality. (5) If, during a routine autopsy by a hospital pathologist, evidence is encountered which indicates that the death should be under the jurisdiction of the medical examiner: (a) The death then shall become a medical examiner case; (b) The hospital agent immediately shall notify the police or sheriff, who will in turn notify the medical examiner; and (c) The hospital pathologist shall discontinue the autopsy pending the arrival of the medical examiner. (6) Clinical and Autopsy Reports from Hospitals. Whenever a medical examiner case is autopsied in a hospital, the hospital agent shall submit to the medical examiner, without delay, a clinical summary report, preferably filled out by the physician most familiar with the case, and a provisional anatomical diagnosis, and later a copy of the final autopsy report. #### Regulation .09 Anesthetic Deaths. *COMAR 10.35.01.09* In the case of any anesthetic death occurring in Maryland, the hospital in which the death occurred shall notify immediately, by telephone, the Chief Medical Examiner or a Deputy Chief Medical Examiner, an assistant medical examiner, or the deputy medical examiner of the county in which the death occurred. #### Regulation .10 Entry to Storage or Autopsy Room at Office of the Chief Medical Examiner. *COMAR 10.35.01.10* An individual, other than a member of the staff of the Chief Medical Examiner, may not enter the storage room or the autopsy room while work is being carried on there, except with the permission of the Chief Medical Examiner or the medical examiner performing the work. #### Regulation .11 Tissue Recovery. *COMAR 10.35.01.11* Whenever an authorized organ and tissue procurement organization has informed the Chief Medical Examiner or the Chief Medical Examiner's deputy or assistant medical examiner that there is a need for tissue for research or transplantation, the Chief Medical Examiner shall allow the authorized organ and tissue procurement organization to make a recovery if: A. Proper authorization has been provided to the medical examiner; B. The body has been tested to determine its suitability for transplantation; C. An autopsy is going to be performed and the removal does not interfere with the subsequent investigation or examination; and D. The medical examiner does not know of an objection to the autopsy or donation of tissue by the next of kin. #### Regulation .12 Donation of Internal Organs for Transplantation. *COMAR 10.35.01.12* A. Whenever there is an immediate need for an internal organ as a transplant, that is, heart, lung, kidney, liver, pancreas, spleen, lymph nodes, or adrenal gland, a medical examiner may provide the organ, if requested by a transplant surgeon, under the following conditions: (1) The medical examiner has jurisdiction over the body of a decedent; (2) The body has been tested to determine its suitability; (3) The hospital representative and treating physician have obtained proper authorization for this decedent; (4) A reasonable, unsuccessful search has been made by the procurement organization as required by Estates and Trusts Article, §4–512(f), Annotated Code of Maryland; (5) No objection by the next of kin is known or reasonably foreseen by the medical examiner; and (6) The removal of the organ requested for transplant does not interfere with an investigation or autopsy. B. Whenever a medical examiner on duty determines that an organ cannot be removed for one of the reasons stated in Sec. A of this regulation, the transplant surgeon may request that this decision be reviewed by the Chief Medical Examiner, a Deputy Chief Medical Examiner, or their designee. C. Whenever a decedent is determined to have died by some violent means, the medical examiner may not authorize removal of the requested organs without observation by the medical examiner or the medical examiner's agent. #### Regulation .13 Administrative Review of Correction of Findings and Conclusions. *COMAR 10.35.01.13* A. Except in a case of a finding of homicide, a person in interest as defined in General Provisions Article, §4-101, Annotated Code of Maryland, may request the Office of the Chief Medical Examiner to correct findings and conclusions on the cause and manner of death recorded on a certificate of death under General Provisions Article, §4-502, Annotated Code of Maryland within 180 days after a medical examiner files those findings and conclusions in accordance with Health-General Article, §5-309(d), Annotated Code of Maryland. B. A person in interest, has the meaning stated in General Provisions Article, §4-101, Annotated Code of Maryland. C. The request to correct the findings and conclusions on a death certificate shall: (1) Be in writing to the Chief Medical Examiner; (2) Describe the requested change precisely; and (3) State the reasons for the change. D. Within 60 days after receiving the request in §C of this regulation, the Chief Medical Examiner shall provide the person in interest written notice of the action taken. E. If the Chief Medical Examiner denies the request to correct findings and conclusions on the cause of death, the person in interest may appeal the denial in writing within 15 days to the Secretary. The Secretary shall refer the matter within 15 days of receipt to the Office of Administrative Hearings. F. An administrative law judge shall conduct a hearing both on the denial and on the establishment of the findings and conclusions on the cause of death. G. Upon reviewing the findings of fact submitted by an administrative law judge, the Secretary or the Secretary's designee shall issue an order within 60 days to: (1) Adopt the findings of the administrative law judge; or (2) Reject the findings of the administrative law judge and affirm the findings of the medical examiner. H. If the Secretary or Secretary's designee rejects the findings of an administrative law judge, the person in interest may appeal that rejection to a circuit court of competent jurisdiction under Maryland law. I. If the final decision of the Secretary or the Secretary's designee, or of a court of competent jurisdiction on appeal establishes a different finding or conclusion on the cause or manner of death of a deceased than that recorded on the certificate of death, the medical examiner shall amend the certificate to reflect the different finding or conclusion. J. The medical examiner shall send a change letter to the Division of Vital Records to amend the certificate of death, to reflect the final decision of the Secretary or Secretary's designee, or a court of competent jurisdiction. K. The final decision of the Secretary or the Secretary's designee, or of a court in an appeal under this regulation, may not give rise to any presumption concerning the application of any provision of or the resolution of any claim concerning a policy of insurance relating to the deceased. L. If the findings of the medical examiner are upheld by the Secretary, the appellant is responsible for the costs of the contested case hearing, based on the billing rate established by the Office of Administrative Hearings. Otherwise, the Department is responsible for the costs. #### Regulation .14 Release of Medical Examiner's Records. *COMAR 10.35.01.14* A. Individual files of the Chief Medical Examiner are confidential medical records protected from disclosure under the provisions of Health-General Article, §4-301, Annotated Code of Maryland, and General Provisions Article, §§4-329 et. seq., Annotated Code of Maryland. B. An exception to these confidential medical records is the official medical examiner's autopsy report. This report is a public record and is generally subject to disclosure under General Provisions Article, §4-329, Annotated Code of Maryland, unless the case is subject to an ongoing investigation, or other appropriate reason for denial of disclosure exists. C. Records request by court order or subpoena shall be subject to the fee schedule set forth herein. D. Fee Schedule. (1) Autopsy reports may be sent electronically to the requestor. The fees schedule is the same for paper or electronic reports and is as follows: (a) No fee for a first-degree relative, as defined by COMAR 10.35.01.01B; and (b) A fee of $50 for all others may be charged for providing a requested autopsy report. (2) Requests for other information or material shall be accompanied by a court order or subpoena unless the Custodian of Records determines compelling circumstances exist warranting the release of materials. If releasable, the contents of the file will be copied at a cost of $1 per page with a minimum charge of $25 excluding any item independently listed in §D of this regulation. (3) Photographs are copied electronically. There is a $50 processing fee for each digital record, plus $5 per each image copied. X-rays and CT scans are copied electronically. There is a $50 processing fee for each digital record, plus $25 per X-ray. (4) Slides are copied electronically. There is a $50 processing fee for each digital record, plus $20 for each image copied. Slides may be viewed in the Office of the Chief Medical Examiner facility at a rate of $200 for the first hour and $50 for every 15 minute increment thereafter, partial or whole. The reviewer will have access to the medical examiner during the review. (5) A proof of death document may be obtained for $20. (6) If any or all of the items listed in §D of this regulation are requested in digital format, an additional fee of $60 shall apply. (7) These fees do not apply if the releasable documents are viewed only, by appointment, at the OCME, at the discretion of the custodian of records. E. An individual, other than the custodian of the records of the Office of the Chief Medical Examiner or a designee, may not copy or distribute a copy of the official report of the Office of the Chief Medical Examiner. #### Regulation .15 Communicable Disease. *COMAR 10.35.01.15* If, during the investigation of a death under the jurisdiction of the Office of the Chief Medical Examiner, a communicable disease is identified, it shall be reported by the medical examiner in writing within 24 hours to the health officer in the appropriate jurisdiction and to the deputy State health official, on the forms supplied by the Maryland Department of Health, in accordance with COMAR 10.06.01.04. #### Regulation .16 Child Abuse or Neglect, or Both. *COMAR 10.35.01.16* A death that is investigated by the Office of the Chief Medical Examiner that is found to be caused by or related to child abuse or neglect shall be reported by a medical examiner orally and in writing to local departments of social services and the local law enforcement agency of the jurisdiction in which the child last resided, in accordance with Family Law Article, §5-704, Annotated Code of Maryland. #### Regulation .17 Notification of Exposure to Contagious or Infectious Disease. *COMAR 10.35.01.17* Whenever it is required that the Office of the Chief Medical Examiner notify a firefighter, emergency medical technician, rescue squad member, law enforcement officer, correctional officer, etc., of exposure to contagious disease or virus, and pursuant to Health-General Article, §18-213, Annotated Code of Maryland, the following procedures shall be followed: A. A medical examiner shall review information gathered in the course of the postmortem examination, including testing for contagious disease or viruses; B. If evidence of contagious disease or virus, as defined in Health-General Article, §18-213, Annotated Code of Maryland, is identified in the test carried out in the postmortem examination, this information shall be provided by the Office of the Chief Medical Examiner to the officially designated agency representative of the appropriate firefighter, emergency medical technician, rescue squad member, law enforcement officer, correctional officer, etc., with a copy to each of these. C. The Office of the Chief Medical Examiner shall verbally notify the agency-designated representative within 48 hours after confirmation of the diagnosis, and subsequently confirm that notice, in writing, and in a manner that protects the confidentiality of the patient; and D. The agency representative shall notify the individual believed to have been exposed to the contagious disease or virus. #### Regulation .18 Deaths in a State-Funded or State-Operated Facility. *COMAR 10.35.01.18* A. A death in a State-funded or State-operated facility which constitutes a medical examiner's case, as defined in Health-General Article, §5-308, Annotated Code of Maryland, shall be investigated by the Office of the Chief Medical Examiner. B. Notification and Investigation. The sheriff, police, or chief law enforcement officer, in the jurisdiction where a death occurs, shall notify the medical examiner whenever a death that constitutes a medical examiner's case occurs in a State-funded or State-operated facility. If the death may have occurred by violence, by suicide, by casualty, suddenly when the person was in apparently good health, not attended by a physician, or in any suspicious or unusual manner, the medical examiner or investigator shall: (1) Respond directly to the administrative head of the facility; (2) Conduct an investigation; (3) Complete the investigation report; and (4) Arrange to have the body sent to the Office of the Chief Medical Examiner for an autopsy, if necessary. C. Completion of Investigation Report. (1) A medical examiner or investigator shall document in an investigation report all of the information regarding the death that was: (a) Gathered in the course of the investigation; and (b) Provided by the administrative head of the facility to the sheriff, police, chief law enforcement official, or health officer in the jurisdiction where the death occurred. (2) A medical examiner or investigator shall append to an investigation report the written report of the death that the administrative head of the facility provided to the sheriff, police, chief law enforcement official, or health officer in the jurisdiction where the death occurred. (3) Required Contents of Report. The report of the administrative head of a facility where the death occurred shall contain all the information set out in Health-General Article, §10-713, Annotated Code of Maryland. The report: (a) May be oral, if followed by a written report within 5 working days from the date of the death, or written; and (b) Shall contain the following relevant information: (i) The name, age, and sex of the deceased; (ii) The time of discovery of the death; (iii) The deceased's place of residence at the time of death; (iv) If the death occurred in a place other than the residence of the deceased, the location of the body at the time of discovery; (v) The place where the body was found; (vi) The name of the person who took custody of the body; (vii) The name of the person evaluating the death, if known; (viii) Whether an autopsy is being performed, if known; (ix) The name, address, and telephone number of the next of kin or legal guardian, if known; and (x) Other information the administrative head of the facility determines should be provided to the medical examiner. (4) The report of the investigation by the Office of the Chief Medical Examiner constitutes an individual file of the Chief Medical Examiner not subject to disclosure under General Provisions Article, §4-101 et seq, Annotated Code of Maryland. #### Regulation .19 Deputy Medical Examiners/Forensic Investigators. *COMAR 10.35.01.19* A. The Chief Medical Examiner shall appoint one or more deputy medical examiners and forensic investigators for each county. B. The Chief Medical Examiner may appoint a deputy medical examiner from a list of qualified individuals submitted by the county medical society. However, the Chief Medical Examiner may appoint a deputy medical examiner for the county without a list if there is no county medical society or if the medical society does not submit a list of names. C. Each deputy medical examiner appointed shall be a physician. D. The Chief Medical Examiner shall select a forensic investigator from a list provided by the Deputy Chief Medical Examiner for Statewide services. E. Entitled Fees. (1) As provided in the State budget, for each medical examiner’s case investigated, the deputy medical examiner or forensic investigator is entitled to a fee of $150. (2) If the case does not meet the requirements of Health-General Article, §5-308, Annotated Code of Maryland, and is declined, the deputy medical examiner or forensic investigator is entitled to a decline fee of $12.50. (3) The deputy medical examiner is entitled to $25 for certifying the death and completing the death certificate. #### Regulation .20 Body Transportation Reimbursement. *COMAR 10.35.01.20* A. The deputy medical examiner or forensic investigator shall arrange for body transportation services of human remains from a scene of death in Maryland to a specified location within Maryland. B. The deputy medical examiner or forensic investigator shall contact local county funeral directors or appropriate body transportation service providers within their jurisdiction, on a rotational basis, to arrange for body transportation services. C. Funeral directors and body transportation service providers are eligible to transport human remains for the Office of the Chief Medical Examiner. However, it is the responsibility of each local funeral director or body transportation service to notify the deputy medical examiner or forensic investigator if they are interested in providing this service for the State. D. Providers of body transportation services shall be available 24 hours a day, 7 days per week, 365 days per year to provide body transportation services, as needed, and shall provide their own equipment to transport human remains. E. Human remains shall be accorded the proper dignity expected under accepted mortuary standards and practices, and shall be handled in accordance with standard precautions as defined by COMAR 10.06.01.02B and the Office of the Chief Medical Examiner guidelines to protect remains and evidence. F. Payment. (1) Providers of body transportation services shall be paid as provided in the State budget, $3.50 per mile, one way, plus any tolls, and a scene response fee of $100, with a minimum total payment of $200 from the scene of death to a designated location. The mileage shall be verified by the OCME. (2) This is the sole compensation the provider is entitled to, and the provider or any other person may not submit a charge to any other party, including the family of the deceased, for this service. (3) In the case of a victim of a homicide, the transport service shall be paid the rate stated in §F(1) of this regulation to transport the body from the site of autopsy or examination to a location within Maryland specified by the victim's family. (4) The Office of the Chief Medical Examiner is responsible for completing the Transportation of Bodies Report for payment. (5) The Office of the Chief Medical Examiner is responsible for providing a replacement body pouch when the body is transported to that office. #### Regulation .21 Fees for Other Services. *COMAR 10.35.01.21* A. When a deputy medical examiner, or forensic investigator as the examiner’s designee, is called as a witness before a grand jury or in a criminal case, the examiner or investigator is entitled to: (1) The fee that the court sets; and (2) Any additional compensation that a county or court provides. B. When any deputy medical examiner or forensic investigator is called as a witness in a civil case they are entitled to: (1) $20 per hour; and (2) Any additional compensation that a county or court provides. ### Chapter 02 — Testing Blood and Breath for Alcohol *Repealed* **Authority:** Courts and Judicial Proceedings Article, §§10-304 and 10-306; Health-General Article, §§5-307 and 5-311; Annotated Code of Maryland **Administrative History:** Effective date: October 4, 2010 (37:20 Md. R. 1394) **Administrative History:** Regulations .01 — .09 repealed effective May 11, 2026 (53:9 Md. R. 414) ## Subtitle 36 — Board of Examiners of Psychologists ### Chapter 01 — Procedures **Authority:** Health Occupations Article, §§18-206, 18-301(b)(3) and (d), 18-302—18-305, 18-309, and 18-317, Annotated Code of Maryland **Administrative History:** Effective date: July 25, 1970 **Administrative History:** Regulation .05G adopted as an emergency provision effective December 23, 1976 (4:2 Md. R. 73); emergency status expired **Administrative History:** Regulations .01—.17 repealed and new Regulations .01—.15 adopted effective December 20, 1982 (9:25 Md. R. 2484) **Administrative History:** Regulation .02 repealed effective September 25, 1995 (22:19 Md. R. 1473) **Administrative History:** Regulation .05 amended as an emergency provision effective October 23, 1987 (14:23 Md. R. 2412); emergency status extended at 15:7 Md. R. 848 **Administrative History:** Regulation .05 amended effective May 16, 1988 (15:10 Md. R. 1202) **Administrative History:** Regulation .07 amended effective September 25, 1995 (22:19 Md. R. 1473) **Administrative History:** Regulation .11 repealed and new Regulation .11 adopted effective October 29, 1990 (17:21 Md. R. 2530) **Administrative History:** Regulations .01—.15 repealed and new Regulations .01—.12 adopted as an emergency provision effective January 1, 2000 (27:3 Md. R. 325); adopted permanently effective May 1, 2000 (27:8 Md. R. 798) **Administrative History:** Regulation .01B amended effective September 1, 2010 (37:14 Md. R. 938); March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulation .02L adopted effective December 24, 2001 (28:25 Md. R. 2192) **Administrative History:** Regulation .02 amended as an emergency provision effective April 1, 2002 (29:7 Md. R. 617); amended permanently effective June 24, 2002 (29:12 Md. R. 928) **Administrative History:** Regulation .02 amended effective March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulation .04 amended as an emergency provision effective April 1, 2002 (29:7 Md. R. 617); amended permanently effective June 24, 2002 (29:12 Md. R. 928) **Administrative History:** Regulation .04 repealed and new Regulation .04 adopted effective September 1, 2010 (37:14 Md. R. 938) **Administrative History:** Regulations .04-1—.04-4 adopted effective September 1, 2010 (37:14 Md. R. 938) **Administrative History:** Regulation .06G amended effective December 24, 2001 (28:25 Md. R. 2192) **Administrative History:** Regulation .06 amended as an emergency provision effective April 1, 2002 (29:7 Md. R. 617); amended permanently effective June 24, 2002 (29:12 Md. R. 928) **Administrative History:** Regulation .08A amended effective December 12, 2013 (40:24 Md. R. 2017) **Administrative History:** Regulation .08C amended effective March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Chapter revised effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .02L amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .08A, C amended effective February 12, 2018 (45:3 Md. R. 157) **Administrative History:** Regulation .09A amended effective February 12, 2018 (45:3 Md. R. 157) #### Regulation .01 Definitions. *COMAR 10.36.01.01* A. In this subtitle, the following terms have the meanings indicated. B. Terms Defined. (1) “Activities and services” means performing the psychological activities or services that are required training for completing the program in psychology. (2) “Applicant” means an individual seeking a license or registration to practice psychology in Maryland. (3) “Board” means the State Board of Examiners of Psychologists. (4) “Central repository” means the Criminal Justice Information System Central Repository of the Department of Public Safety and Correctional Services. (5) “Criminal history records check” means the performance of both a State criminal history check by the Central Repository and a national criminal history check by the Federal Bureau of Investigation. (6) “Criminal history records information” means information provided by the criminal history records check regarding an applicant’s criminal arrests, charges, convictions, and the disposition of other pending criminal charges. (7) Fellow. (a) “Fellow” means an individual who has obtained the doctoral degree in psychology, or who has completed all of the academic course requirements for a doctoral degree in psychology, and is gaining additional training and experience in a postdoctoral training program in psychology. (b) “Fellow” includes the term resident. (8) “Intern” means an individual who is: (a) Matriculated in a doctoral degree program in psychology; and (b) Fulfilling program requirements by completing a predoctoral internship training program in psychology. (9) “Practice-oriented program” means a clinical, counseling, or school psychology program, or a combination thereof, or a respecialization program. (10) “Student” means an individual who is: (a) Matriculated in a master's or doctoral degree program in psychology; and (b) Fulfilling program requirements by gaining field or practicum experience. (11) “Supervised course of study” means an organized post-baccalaureate program in psychology with identified faculty and training objectives. #### Regulation .02 Application Required for Licensure or Registration. *COMAR 10.36.01.02* A. An application packet for licensure is complete when the following conditions are met: (1) The completed application packet is: (a) Submitted to the Board and notarized; and (b) Accompanied by the required nonrefundable application fee in the form of a personal check, cashier’s check or money order; (2) An application packet includes: (a) Answers to application questions; (b) Documentation of supervised professional experience; (c) Attestations of supervised professional experience submitted to the Board by the persons providing the references; (d) Official transcripts of all post-baccalaureate studies submitted to the Board by the educational institutions; (e) An Examination for Professional Practice in Psychology (EPPP) score, if applicable, submitted to the Board by the Association of State and Provincial Psychology Boards (ASPPB); and (f) Criminal history records check reports are received by the Board; and (3) An applicant who is a nonresident or is not employed within the State submits a statement to show the reasons for seeking licensure in the State. B. An application packet for registration is complete when the following conditions are met: (1) The application packet is: (a) Submitted to the Board and notarized; and (b) Accompanied by the required nonrefundable application fee in the form of a personal check, cashier’s check, or money order; (2) Official transcripts of all studies are submitted to the Board by the educational insitutions; and (3) Criminal history records check reports are received by the Board. C. The official date of receipt of the application is the date on which the Board receives both the: (1) Completed application form; and (2) Required, nonrefundable application fee. D. The Board shall notify the applicant of missing required documents not more than 15 business days after receipt of the application. E. An application is terminated when: (1) The application has not been completed within 1 year of the date the application is submitted; or (2) The applicant fails either the EPPP, if applicable, or the Maryland examination. F. Review of Completed Applications by the Board. (1) The Board shall review an application after the required documents are on file. (2) If the applicant for licensure is applying for limited practice reciprocity, as described in Regulation .07 of this chapter, the application shall be reviewed within 15 business days after the required documents are on file. (3) The Board may request additional information or documentation from the applicant for clarification purposes. (4) An applicant shall be sent notification of the action taken by the Board, to accept or to reject the application. (5) An applicant who is informed of acceptance shall be notified of the time and place of the examinations required in Regulation .06 of this chapter. G. An applicant who is informed of acceptance shall submit the required examination fees to the Board. H. The Board may not approve an applicant for licensure or registration until the Board has: (1) Received and reviewed the criminal history records information; and (2) Approved the application. I. An applicant whose application for licensure or registration is rejected shall be notified of the basis for that rejection. J. An applicant may appeal a rejection of application for licensure or registration by notifying the Board in writing, by certified mail, within 60 days of receipt of the Board’s decision, and by: (1) Submitting new or additional evidence to verify or clarify qualifications; or (2) Requesting an informal hearing before the Board. K. An applicant who fails an examination may begin the application process again by submitting: (1) A new application for licensure or registration along with the required application fee; and (2) At least one current letter of reference. L. Abbreviated Application. (1) A psychologist who holds an active license to practice psychology in good standing in another state and is certified by the American Board of Professional Psychology or credentialed as a Health Service Psychologist by the National Register of Health Service Psychologists may apply for licensure with the Board on an abbreviated application. (2) An abbreviated application for licensure as a psychologist with the Board shall include: (a) Proof of good standing as a licensed psychologist in another state; (b) Proof of certification by the American Board of Professional Psychology or credentialing as a Health Service Psychologist by the National Register of Health Service Psychologists; (c) A passing score on the Maryland Jurisprudence Examination as set forth in Regulation .06A(2) of this chapter; (d) A criminal history records check; and (e) The required, nonrefundable application fee. (3) The Board may not issue a license on an abbreviated application unless the Board has received the results of the applicant’s criminal history records check. #### Regulation .03 Education Required for Licensure. *COMAR 10.36.01.03* A. The applicant for licensure shall have a doctoral degree in psychology as defined in Health Occupations Article, §18-101(c), Annotated Code of Maryland. B. The applicant for registration as a psychology associate shall meet the educational requirement as defined in Health Occupations Article, §18-302(g), Annotated Code of Maryland. #### Regulation .04 Professional Supervised Experience Required for Licensure — General. *COMAR 10.36.01.04* A. An applicant for licensure shall present evidence of having completed 2 years of supervised professional experience before taking the examinations required in Regulation .06 of this chapter. B. The 2 years of supervised professional experience shall consist of a minimum of 3,250 hours. C. Supervision Generally. (1) A minimum of 75 percent of the applicant's supervised professional experience shall be supervised by a psychologist qualified to supervise the activities being performed or the services being rendered. (2) The supervisor shall be: (a) Licensed to practice psychology in Maryland; (b) Exempt from licensure under Health Occupations Article, §18-102(3) or 18-301(b), Annotated Code of Maryland; (c) Licensed, certified, or exempt from licensure or certification in the state or country in which the supervised professional experience is obtained; or (d) A student, fellow, intern, or resident while pursuing a supervised course of study that the Board approves as qualifying training or experience as provided in Health Occupations Article, §18-301(b)(3), Annotated Code of Maryland, provided that the student, fellow, intern, or resident is supervised by an individual meeting criteria of §C(2)(a), (b) or (c) of this regulation. (3) The supervisor shall ensure that any additional supervision is by an individual who has the requisite skills and training to provide supervision. (4) Psychology associates accruing supervised professional experience toward licensure shall receive the required amount of supervision specified in COMAR 10.36.07.03. (5) The applicant shall ensure that there is adequate documentation of the supervised professional experience. (6) The Board may require additional information to be submitted by the applicant or supervisor to assess the extent and quality of the applicant's supervised professional experience. #### Regulation .04-1 Supervised Professional Experience — Programs That Are Not Practice-Oriented. *COMAR 10.36.01.04-1* A. For applicants for licensure graduating from programs that are not practice-oriented, supervised professional experience may be accrued in professional work in psychology using the methods, principles, and procedures of psychology, including, but not limited to: (1) Teaching; (2) Research; and (3) Industrial or organizational consultation. B. In order for the experience to qualify as full-time supervised professional experience, the applicant shall receive a minimum of 1 hour of individual supervision per week at a face-to-face meeting with the supervisor. C. In exceptional circumstances, the Board may waive the requirement for face-to-face supervision: (1) For pre-doctoral experience, if the academic program director attests to the nature of the circumstances and assures the Board that the quality of the supervision was not compromised; or (2) For post-doctoral experience, if the applicant: (a) Petitions the Board for a waiver before beginning the supervised experience; and (b) Offers an alternative modality for supervision, including but not limited to televideo conferencing that does not substantially diminish the adequacy of the supervision. #### Regulation .04-2 Supervised Professional Experience — Practice-Oriented Programs. *COMAR 10.36.01.04-2* A. For applicants for licensure graduating from practice-oriented programs, supervised professional experience may be accrued through: (1) Pre-internship; (2) Internship; (3) Pre-doctoral post-internship; or (4) Post-doctoral experiences. B. The academic training program director or the post-doctoral training supervisor shall attest to the hours accrued to meet the requirements of this regulation on a form required by the Board. C. An applicant may utilize pre-internship and pre-doctoral post-internship experience: (1) To accrue up to 1,500 hours toward the supervised professional experience required for licensure; and (2) That occurs following the completion of the first year of the doctoral program. D. Pre-internship and pre-doctoral post-internship experiences shall: (1) Consist of an organized sequence of training that is of increasing complexity to prepare the student for internship; (2) Follow appropriate academic preparation; (3) Be overseen by the graduate training program; (4) Be an extension of the student's academic coursework and within the scope of education received; (5) Be in service-related activities such as treatment, assessment, interviews, report writing, case presentations, supervision, and consultation for at least 50 percent of the training experience; and (6) Be devoted to face-to-face client contact for at least 25 percent of the training experience. E. Pre-internship and pre-doctoral post-internship experiences shall contain a written training plan that: (1) Includes the responsibilities of the student, training site, and graduate training program; (2) Describes how the student's time will be allotted; (3) Ensures the quality, breadth, and depth of the training experience by specifying the: (a) Goals and objectives of the training experience; (b) Methods of evaluation of the student's performance; and (c) Rules governing the training experience; (4) Specifies the requirements of supervision to include: (a) The nature of supervision; (b) The identities of supervisors; and (c) The form and frequency of feedback from the agency supervisor to the training faculty; (5) Provides rationale for the training experience based on previous academic preparation and previous training to ensure that the overall experience is organized and sequential; and (6) May be provided to the Board with the application to document the pre-internship or pre-doctoral post-internship experience. F. Pre-internship and Pre-doctoral Post-internship Supervision Requirements. (1) Every 20 hours of pre-internship experience and pre-doctoral post-internship shall include the following: (a) At least 2 hours of regularly scheduled, formal, face-to-face individual supervision that addresses the direct psychological services provided by the student; and (b) At least 2 hours of other learning activities such as: (i) Case conferences; (ii) Seminars on applied issues; (iii) Conducting co-therapy with a staff person including discussion of the case; or (iv) Group supervision. (2) In exceptional circumstances, the Board may waive the requirement for face-to-face supervision if the academic program director attests to the nature of the circumstances and assures the Board that the quality of supervision was not compromised. G. Internship experiences shall: (1) Consist of a minimum of 1,750 hours of supervised experience; and (2) Be completed within 24 months. H. The internship program shall be: (1) Accredited by the American Psychological Association (APA) or the Canadian Psychological Association (CPA); (2) A member program of the Association of Psychology Postdoctoral Internship Centers (APPIC); or (3) Part of an academic program that: (a) Is approved or designated by the: (i) APA; (ii) CPA; or (iii) Association of State and Provincial Psychology Boards (ASPPB)/National Register; and (b) Includes an internship that is approved by the program's academic training director as meeting its criteria for an internship. I. Post-Doctoral Supervised Professional Experience—Practice-Oriented Programs. (1) A maximum of 1,500 hours of the professional supervised experience may be obtained through post-doctoral supervised experience. (2) Post-doctoral supervised experience shall be completed if an applicant does not have 3,250 hours of pre-doctoral supervised experience. #### Regulation .04-3 Post-Doctoral Supervised Professional Experience — General. *COMAR 10.36.01.04-3* A. A supervisor is ethically and legally responsible for all supervisee work covered by a written supervision agreement. B. Supervisees shall use titles indicating their training status, such as “psychology resident”, “psychology intern”, or “psychology supervisee”. C. Supervised experience shall be appropriate to the area or areas of professional activity in which the supervisee intends to practice. D. There shall be at least 1 hour of individual supervision for every 20 hours of service related activities. E. The supervisor and the supervisee shall keep records of experience and supervision hours. F. At the conclusion of the post-doctoral supervision experience: (1) The supervisor shall prepare a written evaluation, including: (a) The hours spent in various service related activities; (b) The number of successfully completed supervised hours; and (c) Any hours not successfully completed; and (2) If any hours were not successfully completed, the Board may require additional hours of supervision. G. Supervision shall be face-to-face with an on-site supervisor. H. Under exceptional circumstances, and before beginning a supervised professional experience, an applicant for licensure may petition the Board to waive the requirement for face-to-face supervision or to receive supervision from a psychologist not on site. I. The Board may waive the requirement for face-to-face supervision only when the alternative modality for supervision, including but not limited to televideo conferencing, does not substantially diminish the adequacy of the supervision. J. If a supervisee is accruing post-doctoral supervision as a registered psychology associate, the supervisee shall also comply with the requirements of Regulation .04-4 of this chapter. #### Regulation .04-4 Post-Doctoral Supervised Professional Experience as a Registered Psychology Associate. *COMAR 10.36.01.04-4* A. An applicant accruing post-doctoral supervised experience in an activity that is not exempt under Health Occupations Article, §18-301 or 18-102(3), Annotated Code of Maryland, shall apply to the Board for registration as a psychology associate in accordance with COMAR 10.36.07. B. Exempted activities under Health Occupations Article, §§18-301 and 18-102(3), Annotated Code of Maryland, include: (1) Activities as a student, intern, resident, or fellow while pursuing a supervised course of study in psychology that the Board approves as qualifying training and experience; (2) Activities under the supervision of, and in connection with, a psychologist employed by: (a) Any agency of the federal government; (b) The Maryland Department of Juvenile Services; (c) A political subdivision of this State; or (d) A chartered educational institution; or (3) Non-profit activities of a bona fide religious organization that is exempt from taxation under Section 501(c)(3) of the Internal Revenue Code. C. Registered psychology associates accruing post-doctoral supervised professional experience toward licensure shall obtain supervision in accordance with the requirements of COMAR 10.36.07. #### Regulation .05 Applications for Licensure from Nonresidents. *COMAR 10.36.01.05* A. When submitting an application for licensure, an applicant who is a nonresident or does not practice psychology in Maryland and who does not intend to reside or practice in Maryland, shall submit a statement showing that the applicant's licensure would be in the interest of the citizens or government of Maryland. B. The Board shall determine whether to accept or reject the statement. C. In the event of unfavorable determination, the Board shall notify the applicant that the application for licensure has been rejected. D. The applicant may appeal this rejection as specified in Regulation .02 of this chapter. E. Until licensed to practice psychology in Maryland, an applicant may not practice psychology in Maryland by virtue of holding a valid license or certification to practice psychology in another state unless the Board authorizes a specific exception. #### Regulation .06 Examinations Required for Licensure or Registration. *COMAR 10.36.01.06* A. The Board requires applicants for licensure to receive passing scores of at least: (1) A scaled score of 500 on the Examination for Professional Practice in Psychology (EPPP) for examinations administered on or after January 1, 2002, or a score of 73 percent on the Examination for Professional Practice in Psychology (EPPP) prepared and scored before January 1, 2002; and (2) 75 percent on the Maryland Examination prepared and scored by the Board. B. The Board requires applicants for registration to receive a passing score of at least 75 percent on the Maryland Examination prepared and scored by the Board. C. The Board shall ensure that the Maryland Examination tests applicants for licensure or registration on: (1) The Code of Ethics and Professional Conduct; and (2) Other regulations and laws pertaining to the practice of psychology. D. The Board shall provide each applicant access to all regulations and laws tested on the Maryland Examination. E. An applicant is required to take examinations administered by the Board or the Board's agent at the designated times and places. F. The Board shall refund the examination fee if a written request to cancel the application or examination is received from the applicant: (1) At least 2 weeks before the examination date; or (2) At a later time if the Board determines there was good cause. G. Limited Examination Reciprocity for Licensure Applicants. (1) The Board shall determine the required examinations for each applicant, although the Maryland Examination may not be waived. (2) The Examination for Professional Practice in Psychology may be waived for an applicant authorized by law to practice psychology in another state that did not require the Examination for Professional Practice in Psychology, if the applicant is currently licensed or certified for the independent practice of psychology in another state. (3) The Examination for Professional Practice in Psychology (EPPP) shall be waived for an applicant licensed or certified for the independent practice of psychology in another state who submits evidence of having attained a score of at least 73 percent on any administration of the Examination for Professional Practice in Psychology (EPPP) before January 1, 2002, or a scaled score of 500 on any administration of the Examination for Professional Practice in Psychology (EPPP) on or after January 1, 2002. (4) The examination for Professional Practice in Psychology shall be waived for an applicant who: (a) Is licensed to practice psychology in another state; and (b) Has met the requirements for and holds a current Certificate of Professional Qualification in Psychology issued by the Association of State and Provincial Psychology Boards. #### Regulation .07 Exceptions to Licensure. *COMAR 10.36.01.07* A. A student, intern, or fellow may qualify for an exception to licensure while performing the activities and services of a supervised course of study in psychology with the following requirements: (1) The identified faculty shall provide the supervision; (2) The individual shall receive the amount of supervision: (a) Set by the educational or internship program; or (b) In accordance with Regulation .04 of this chapter for: (i) Students or interns who want to obtain the professional supervised experience required for licensure, and (ii) Fellows; (3) The individual providing psychological services under this exception shall use one of the following titles: (a) Psychology student; (b) Psychology intern; (c) Psychology resident; or (d) Psychology fellow; and (4) This exception to licensure terminates when the requirements of the training program in psychology are completed. B. Limited Practice Reciprocity. (1) A nonresident certified or licensed to practice psychology may be granted a temporary exception to practice psychology in Maryland if the: (a) Board receives from the applicant a completed application and application fee within 90 days of establishing residence in Maryland and on or before the next application due date; (b) Completed application includes a verification from another state licensing Board or authority that the applicant's license or certification to practice psychology in the other state is in good standing; (c) Applicant is scheduled to take the next Board-administered examinations required for licensure; (d) Board approves the application and sends notification of its action not later than 35 days before the scheduled examination; and (e) Applicant pays the required examination fee to the Board at least 30 days before the scheduled examination. (2) The Board shall withdraw the temporary exception to practice psychology if the applicant fails an examination required by the Board. (3) In granting an extension for examination set forth in Health Occupations Article, §18-301(c), Annotated Code of Maryland, the Board shall determine whether the applicant has good cause for being unable to take the first scheduled examination for which the applicant is eligible. (4) In authorizing an exception set forth in Health Occupations Article, §18-301(d), Annotated Code of Maryland, the Board: (a) Shall determine whether the circumstances warrant an exception to licensure, taking into account the: (i) Qualifications of the nonresident psychologist, (ii) Psychological services to be provided, and (iii) Duration of the exception to licensure; and (b) May impose any limitations on the psychologist's practice of psychology that the Board considers to be appropriate. #### Regulation .08 License Renewal, Expiration, and Inactive Status. *COMAR 10.36.01.08* A. Renewal. (1) A license shall expire on March 31, unless it is renewed for an additional term as provided in this section. (2) A license may not be renewed for a term longer than 2 years. (3) At least 90 days before the license expires, the Board shall send a renewal notice to the licensee: (a) By first class mail to the last known address of the licensee; or (b) If requested by the licensee, by electronic means to the last known electronic mail address of the licensee. (4) If a renewal notice sent by electronic means under §A(3)(b) of this regulation is returned to the Board as undeliverable, the Board shall send a renewal notice to the licensee by first–class mail to the last known address of the licensee. (5) The renewal notice shall state: (a) The procedure to follow; (b) Continuing education requirements; (c) The date on which the current license expires; (d) The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the license expires; and (e) The amount of the renewal fee. (6) A licensee who did not submit to a criminal history records check upon initial licensure with the Board shall submit to a criminal history records check upon the licensee’s first renewal with the Board after January 1, 2019. (7) Every 6 years following the initial submission of a criminal history records check to the Board, a licensee applying for renewal shall submit to a criminal history records check. (8) Upon receipt of a licensee’s criminal history records information in accordance with §A(6) and (7) of this regulation, the Board shall consider the following factors in determining whether to renew a license: (a) The age at which the crime was committed; (b) The circumstances surrounding the crime; (c) The length of time that has passed since the crime; (d) Subsequent work history; (e) Employment and character references, if provided; and (f) Other evidence that demonstrates whether the licensee poses a threat to the public health or safety. (9) The Board may not renew a license if the Board has not received the results of a criminal history records check required pursuant to §A(6) and (7) of this regulation. B. Expiration. A license automatically expires when the psychologist fails to meet the renewal requirements by March 31. C. Inactive Status. (1) A psychologist in good standing may request inactive status for 2 years upon: (a) Notification to the Board; and (b) Payment of the required fee. (2) A licensee on inactive status may apply to have the inactive license status extended for an additional 2 years upon payment of the inactive status fee. (3) The license on inactive status may be reinstated by: (a) Completing an application for renewal; (b) Paying the renewal fee; (c) Verifying that continuing education requirements have been satisfied as set forth in COMAR 10.36.02; and (d) Submitting to a criminal history records check, if the license has been on inactive status for a period of 1 year or more. #### Regulation .09 Registration Renewal and Expiration. *COMAR 10.36.01.09* A. Renewal. (1) A registration shall expire on March 31 unless it is renewed for an additional term as provided in this section. (2) A registration may not be renewed for a term longer than 2 years. (3) At least 90 days before the registration expires, the Board shall send a renewal notice to the registrant: (a) By first class mail to the last known address of the registrant; or (b) By electronic means to the last known electronic mail address of the registrant. (4) The renewal notice shall state: (a) The date the registration expires; (b) Continuing education requirements; (c) The date by which the renewal application must be received by the Board for the renewal to be issued and mailed before the registration expires; and (d) The amount of the renewal fee. (5) Every 6 years following the initial submission of a criminal history records check to the Board, a registrant applying for renewal shall submit to a criminal history records check. (6) Upon receipt of a registrant’s criminal history records information in accordance with §A(5) of this regulation, the Board shall consider the following factors in determining whether to renew a registration: (a) The age at which the crime was committed; (b) The circumstances surrounding the crime; (c) The length of time that has passed since the crime; (d) Subsequent work history; (e) Employment and character references, if provided; and (f) Other evidence that demonstrates whether the registrant poses a threat to the public health or safety. (7) The Board may not renew a registration if the Board has not received the results of a criminal history records check required pursuant to §A(5) of this regulation. B. Expiration. A registration automatically expires when the psychology associate fails to meet the renewal requirements by March 31. #### Regulation .10 Petitioning for Reinstatement Following Revocation. *COMAR 10.36.01.10* The Board may not consider a petition for reinstatement of a license or registration to practice psychology that has been revoked until at least 5 years have passed from the date of revocation. #### Regulation .11 Board Meetings. *COMAR 10.36.01.11* The Board shall meet a minimum of six times a year with additional meetings being scheduled as the business of the Board may require. #### Regulation .12 Annual Report of the Board. *COMAR 10.36.01.12* A. The Chairman of the Board shall submit an annual report to the Board for approval before the Board's submission of the report to the Secretary of Health. B. The Board shall include in the report: (1) A summary of the more important actions of the Board; (2) Relevant statistical and fiscal data; and (3) A summary of concerns or anticipated future changes in the course of action of the Board. #### Regulation .13 Petitions. *COMAR 10.36.01.13* A. Any person may petition the Board in writing for an interpretation of: (1) Health Occupations Article, Title 18, Annotated Code of Maryland; and (2) COMAR 10.36.01—10.36.07. B. A copy of the Board's interpretation or decision shall be mailed to the petitioner. ### Chapter 02 — Continuing Education **Authority:** Health Occupations Article, §18-309(f), Annotated Code of Maryland **Administrative History:** Effective date: February 24, 1978 (5:4 Md. R. 227) **Administrative History:** Regulation .01A; .03B; .04A and C; .05A, C, and D; and .06 amended effective July 19, 1982 (9:14 Md. R. 1431) **Administrative History:** Chapter revised effective February 20, 1989 (16:3 Md. R. 344) **Administrative History:** Regulations .02 — .06 repealed and new Regulations .02 — .06 adopted as an emergency provision effective January 1, 2000 (27:3 Md. R. 325); adopted permanently effective May 1, 2000 (27:8 Md. R. 798) **Administrative History:** Regulation .06A amended as an emergency provision effective July 1, 2008 (35:17 Md. R. 1482); amended permanently effective October 6, 2008 (35:20 Md. R. 1775) **Administrative History:** Regulations .01 — .06 repealed and new Regulations .01 — .09 adopted effective December 31, 2009 (36:26 Md. R. 1995) **Administrative History:** Regulation .01 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .02B amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .03A amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .04 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .05 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .05-1 adopted effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .08 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .09B amended effective May 25, 2015 (42:10 Md. R. 684) #### Regulation .01 Scope. *COMAR 10.36.02.01* This chapter applies to all psychologists and psychology associates who want to renew their licensure or registration in the State. #### Regulation .02 Definitions. *COMAR 10.36.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Activity” means any authoring, editing, learning, presenting, program developing, reviewing, or teaching which meets the objectives of continuing education. (2) “Approved program” means an activity by an authorized sponsor. (3) “Authorized sponsor” means an individual or organization whose programs are accepted by the Board as continuing education activity. (4) “Board” means the Board of Examiners of Psychologists. (5) “Continuing education (CE)” means learning experiences that: (a) Are professional activities beyond that required for licensure or registration; (b) Are relevant to psychological practice, education, or science; (c) Enable psychologists and psychology associates to keep pace with emerging issues and technology; and (d) Allow psychologists and psychology associates to develop, maintain, and increase competencies in order to improve services to the public and enhance contributions to the profession. (6) “Continuing education (CE) hour” means approximately 1 hour of continuing education activity, unless stated otherwise in Regulation .04 of this chapter. (7) Course. (a) “Course” means an activity: (i) With one or more instructors who are experts in the topic and impart knowledge or professional skills by a systematic presentation to participants; (ii) That may be offered in person or in real time through electronic means; and (iii) That allows for interaction between the leader and the participants or among the participants. (b) “Course” includes seminars, symposiums, and workshops. (8) “Independent study” means an activity requiring the study of print or electronic materials offered by approved sponsors approved for CE for independent or home study that is not a course as defined in §B(7) of this regulation. (9) “Peer consultation group” means a group of psychologists that meets in person, in a structured and organized manner, and discusses the clinical practice of psychology in order to broaden professional knowledge and expertise. (10) “Reporting period” means a 2-year period beginning on April 1, except as stated in Regulation .04C of this chapter, during which the completion of a minimum number of CE hours is required to renew a license or registration by March 31 following the reporting period. #### Regulation .03 Goals of Continuing Education Activities. *COMAR 10.36.02.03* To qualify for approval by the Board, continuing education activities: A. Shall meet one or more of the following objectives: (1) Maintains the professional competency of psychologists or psychology associates; (2) Increases the professional skills and knowledge of psychologists or psychology associates; (3) Prepares psychologists or psychology associates for new roles or responsibilities in the practice of psychology; or (4) Expands the science of psychological theory, method, or practice; and B. May not include: (1) Business meetings; (2) Professional committee meetings; and (3) Presentations and publications primarily intended for a lay audience. #### Regulation .04 Requirements. *COMAR 10.36.02.04* A. A psychologist shall complete a minimum of 40 CE hours during each reporting period with a: (1) Maximum of 20 CE hours in independent study; (2) Minimum of 3 CE hours in activities whose content area is: (a) Laws pertaining to the practice of psychology; (b) Ethics and professional conduct in the practice of psychology; or (c) Managing risks associated with the practice of psychology; (3) Minimum of 3 CE hours in activities designed to enhance competence in the provision of psychological services to culturally diverse populations; and (4) If the psychologist supervised psychology associates during the reporting period, minimum of 3 CE hours in activities designed to enhance competence in the provision of clinical supervision. B. A psychology associate shall complete a minimum of 20 CE hours during each reporting period with a: (1) Maximum of 10 CE hours in independent study; (2) Minimum of 3 CE hours in activities whose content area is: (a) Laws pertaining to the practice of psychology; (b) Ethics and professional conduct in the practice of psychology; or (c) Managing risks associated with the practice of psychology; and (3) Minimum of 3 CE hours in activities designed to enhance competence in the provision of psychological services to culturally diverse populations. C. During each reporting period, CE hours may be earned only once for the same activity. D. Reporting Period. (1) The reporting period for psychologists or psychology associates with license or registration numbers ending with an: (a) Odd digit will be March 31 of odd years; and (b) Even digit or 0 will be March 31 of even years. (2) For psychologists or psychology associates receiving their initial license or registration with less than 12 months before the end of their reporting period, CE hours are not required for that reporting period. (3) Psychologists receiving their initial license with 12 months or more before the end of their reporting period shall be required to complete 20 CE hours. (4) Psychology associates receiving their initial registration 12 months or more before the end of their reporting period shall be required to complete 10 CE hours. E. CE Audits. (1) The Board shall randomly audit the continuing education documentation of all psychologists and psychology associates. (2) Psychologists and psychology associates selected for an audit shall renew their license or registration by March 1. (3) Within 10 days following notification by the Board, a psychologist or psychology associate who is audited shall provide: (a) Proof of completion of continuing education activities; (b) A completed continuing education reporting form; and (c) Any additional information that may be requested by the Board to evaluate completion of CE requirements. (4) Proof of completion as required in §D(2)(a) of this regulation may include: (a) Certificates of attendance; (b) Transcripts or course syllabi; (c) Reprints of publications; (d) Test results; or (e) Any other proof of completion acceptable to the Board. (5) To earn CE credits for independent study, a psychologist or psychology associate shall: (a) Pass an examination on the activity; and (b) Be awarded a certificate of completion. #### Regulation .05-1 Peer Consultation Groups. *COMAR 10.36.02.05-1* A. A psychologist may earn CE credit for participation in a peer consultation group. B. A peer consultation group shall: (1) Meet to discuss the clinical practice of psychology; (2) Assign a recording secretary to keep attendance and record a brief summary of what was discussed at the meeting; (3) Meet for no less than 1 hour for every session; and (4) Consist of no fewer than three psychologists and no more than six psychologists. C. The recording secretary: (1) Shall provide a copy of the meeting summary to each psychologist in attendance and keep a copy in a file maintained by the recording secretary; (2) Shall complete, sign, and provide to each psychologist member a certificate at the end of the reporting period that verifies attendance and specifies the number of hours the psychologist participated in the peer consultation group; (3) Shall ensure that another peer consultation group participant act as a substitute recording secretary at any group meeting at which the recording secretary is absent; and (4) May be a role fulfilled by different psychologist participants during the life of the peer consultation group. D. A psychologist participating in a peer consultation group: (1) Shall provide the certificate of attendance to the Board at the time of renewal to verify participation in the peer consultation group; (2) Shall provide copies of the meeting summaries to the Board in the event of a CE audit; (3) Shall only receive CE credit for hours of peer consultation group meetings actually attended; and (4) May participate in more than one peer consultation group, in which case hours of participation in all peer consultation groups shall be added together to calculate CE credit. E. CE hours for participating in a peer consultation group may be earned as follows: (1) One CE hour for 7 to 13 hours of participation in a peer consultation group during the reporting period; (2) Two CE hours for 14 to 20 hours of participation in a peer consultation group during the reporting period; (3) Three CE hours for 21 to 27 hours of participation in a peer consultation group during the reporting period; and (4) Four CE hours for 28 or more hours of participation in a peer consultation group during the reporting period. F. Extra hours of participation in a peer consultation group may not be carried over to the next reporting period for CE credit. #### Regulation .05 Types of Approved Continuing Education Activities. *COMAR 10.36.02.05* A. The total number of hours that may be used to fulfill CE requirements for scholarly activities included in §C of this regulation may not exceed 30 hours for psychologists or 15 hours for psychology associates during each 2-year reporting period. B. If the activity has more than one author or presenter, CE hours are awarded only to the first three authors. C. Approved CE activities include the following: (1) Authoring, editing, presenting, or reviewing a scholarly publication where: (a) A maximum of 20 CE hours for psychologists or 10 CE hours for psychology associates may be earned during each 2-year reporting period for publication by the author or authors of a book during the year of publication; (b) A maximum of 15 CE hours for psychologists or 8 CE hours for psychology associates may be earned for each 2-year reporting period during the year of publication for serving as the: (i) Editor of a book; (ii) Author of a book chapter; or (iii) Author of a scientific peer-reviewed journal article; (c) A maximum of 15 CE hours for psychologists or 8 CE hours for psychology associates may be earned for each 2-year reporting period for service by the editor or associate editor of a peer-reviewed scientific journal; and (d) A maximum of 15 CE hours for psychologists or 8 CE hours for psychology associates may be earned for each 2-year reporting period for service as an editorial board member of a peer-reviewed scientific journal; (2) Three CE hours may be earned for each hour of presentation of the first offering of scholarly papers or courses for an authorized sponsor with a maximum of 15 CE hours for psychologists or 9 CE hours for psychology associates for each 2-year reporting period; (3) Three CE hours may be earned for developing and presenting a scholarly poster with a maximum of 15 CE hours for psychologists or 9 CE hours for psychology associates for each 2-year reporting period; and D. A maximum of 4 CE hours may be earned by a psychologist for participation in a peer consultation group during each 2-year reporting period, as specified in Regulation .05-1 of this chapter. E. CE hours may be earned for attending courses offered by an authorized sponsor specified in Regulation .06 of this chapter. #### Regulation .06 Authorized Sponsors. *COMAR 10.36.02.06* The following organizations and their approved CE sponsors are authorized sponsors of continuing education acceptable to the Board: A. American Psychological Association; B. Association for Psychological Science; C. American Medical Association; D. National Association of Social Workers; E. National Association of School Psychologists; F. Maryland Department of Health (MDH); G. National Institutes of Health; and H. Accredited academic institutions. #### Regulation .07 Denial of License or Registration Renewal for Failure to Meet Continuing Education Requirements. *COMAR 10.36.02.07* A. The Board shall deny a renewal application if: (1) The psychologist or psychology associate did not complete required continuing education hours within the reporting period; or (2) The psychologist or psychology associate did not fulfill audit requirements within 30 days. B. Upon denying a renewal application, the Board shall notify the psychologist or psychology associate by certified mail that the psychologist’s or psychology associate’s renewal application has been denied for failure to comply with the continuing education requirements. C. A psychologist or psychology associate may request a hearing on the denial of the renewal application. The request shall be: (1) In writing; and (2) Received by the Board within 30 days of the notification of denial. D. If requested by the psychologist or psychology associate, the Board shall convene a hearing within a reasonable time on the denial of the renewal application. E. A hearing conducted under this regulation may not be held in accordance with the Maryland Administrative Procedure Act. #### Regulation .08 Continuing Education Required for License Reactivation or License or Registration Reinstatement. *COMAR 10.36.02.08* A. Inactive Status. (1) A psychologist on inactive status who applies for a reactivation of the license with less than 1 year remaining in the reporting period shall: (a) Provide documentation of a minimum of 20 CE hours completed during the current reporting period with not more than 10 hours in independent or home study; and (b) Pay the renewal fee as specified in COMAR 10.36.06. (2) A psychologist on inactive status who applies for a reactivation of the license with more than 1 year remaining in the reporting period shall: (a) Provide documentation of a minimum of 20 CE hours completed during the current reporting period, with not more than 10 hours in independent or home study; (b) Complete the remaining 20 CE hours required by the end of the reporting period, with not more than 10 hours in independent or home study; and (c) Pay the renewal fee as specified in COMAR 10.36.06. B. Expired License or Registration. (1) A psychologist who applies for reinstatement of a license that expired less than 1 year from the date of application shall: (a) Provide documentation of a minimum of 20 CE hours completed during the current reporting period, with not more than 10 CE hours in independent study; (b) Complete the remainder of continuing education requirements by the end of the reporting period; and (c) Pay the reinstatement and renewal fees as specified in COMAR 10.36.06. (2) A psychology associate who applies for reinstatement of a registration that expired less than 1 year from the date of application shall: (a) Provide documentation of a minimum of 10 CE hours completed during the current reporting period, with not more than 5 CE hours in independent study; (b) Complete the remainder of continuing education requirements by the end of the reporting period; and (c) Pay the reinstatement and renewal fees as specified in COMAR 10.36.06. (3) A psychologist who applies for reinstatement of a license that expired more than 1 year but less than 5 years from the date of application shall: (a) Provide documentation of 40 CE hours for the current reporting period; and (b) Pay the reinstatement and renewal fees as specified in COMAR 10.36.06. (4) A psychology associate who applies for reinstatement of a registration that expired more than 1 year but less than 5 years from the date of application shall: (a) Provide documentation of 20 CE hours for the current reporting period; and (b) Pay the reinstatement and renewal fees as specified in COMAR 10.36.06. (5) A psychologist whose license has been expired for more than 5 years and who did not make application to go on inactive status shall reapply for licensure. (6) A psychology associate whose registration has been expired for more than 5 years shall reapply for a registration. (7) The Board may not approve an application for reinstatement until it receives documentation of the minimum CE requirements as set forth in this regulation. #### Regulation .09 Modifications of CE Requirements. *COMAR 10.36.02.09* A. The Board may approve modifications of the CE requirements. B. To request modifications of the CE requirements, a psychologist or psychology associate shall: (1) Make a written request; (2) Provide evidence of a disability or inability to access activities; and (3) Specify acceptable procedures for completion and documentation of the required hours within the reporting period. ### Chapter 03 — Procedure for Board Hearings **Authority:** Health Occupations Article, §§18-206 and 18-315; State Government Article, §10-206; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 — .08 adopted as an emergency provision effective September 29, 1980 (7:21 Md. R. 1988); emergency status expired February 14, 1981 **Administrative History:** Regulations .01 — .09 adopted effective December 3, 1984 (11:24 Md. R. 2069) **Administrative History:** Regulation .05A, B amended effective November 26, 1990 (17:23 Md. R. 2732) **Administrative History:** Chapter revised effective September 4, 2000 (27:17 Md. R. 1620) **Administrative History:** Regulation .01 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .02A amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .09 amended effective May 25, 2015 (42:10 Md. R. 684) #### Regulation .01 Scope. *COMAR 10.36.03.01* This chapter applies to all contested case hearings held under the authority of Health Occupations Article, §18-315, Annotated Code of Maryland, which concern possible action to be taken by the State Board of Examiners of Psychologists under Health Occupations Article, §18-313, Annotated Code of Maryland, regarding the licensure or registration, or discipline of psychologists and psychology associates. This chapter does not apply to conferences or other informal investigations or proceedings. #### Regulation .02 Notice of Hearing. *COMAR 10.36.03.02* A. Written notice of charges and a hearing shall be sent by the Chairman of the Board to the licensee, registrant, or applicant for licensure or registration at least 30 days before the hearing. The notice shall state the date, time, and place of the hearing. It also shall state the issues or charges involved in the proceedings. B. If, by reason of the nature of the proceeding, these issues cannot be fully stated in the notice of the hearing in advance or if subsequent amendment of the issues is necessary, the issues and charges shall be clarified and fully stated as soon as practicable. C. The written notice of charges and a hearing shall be served on the party in person. Instead of personal service, the Board may serve the notice by registered or certified mail, restricted delivery, return receipt requested. #### Regulation .03 Representation of Parties. *COMAR 10.36.03.03* All parties in interest appearing before the Board at formal contested case hearings have the right to appear in person, alone, or by or with counsel. #### Regulation .04 Prehearing Procedures. *COMAR 10.36.03.04* A. Prehearing and Case Resolution Conferences. (1) The Board may set a prehearing conference, or a case resolution conference, or both, upon motion of either party, or on its own motion. (2) The case resolution conference may be used to attempt to settle the case. (3) The prehearing conference may be used to prepare for the hearing by: (a) Delineating the issues, (b) Stipulating to facts, laws, and other matters, (c) Arranging a schedule, and (d) Arranging for the submission of names of witnesses to be called and the subject matter of testimony to be presented in the hearing. B. Discovery on Request. By written request served on the other party and filed with the Board or the Office of Administrative Hearings, a party may require another party to produce, within 15 days, the following: (1) A list of witnesses to be called; (2) Copies of documents intended to be produced at the hearing; or (3) Both §B(1) and (2) of this regulation. C. Mandatory Discovery. (1) Each party shall provide to the other party not later than 15 days before the prehearing conference, if scheduled, or 45 days before the scheduled hearing date, whichever is earlier: (a) The name and curriculum vitae of any expert witness who will testify at the hearing; and (b) A detailed written report summarizing the expert's testimony, which includes the opinion offered and the factual basis and reasons underlying the opinion. (2) If the Board or the Office of Administrative Hearings, as appropriate, finds that the report is not sufficiently specific, or otherwise fails to comply with the requirements of this section, the Board or the Office of Administrative Hearings, as appropriate, shall exclude from the hearing the testimony of the expert and any report of the expert. (3) The Board or the Office of Administrative Hearings, as appropriate, shall consider and decide arguments regarding the sufficiency of the report: (a) At the prehearing conference, if scheduled; or (b) Immediately before the scheduled hearing. (4) If an expert adopts a sufficiently specific charging document as the expert's report, that adoption satisfies the requirements set forth in this section. D. Parties are not entitled to discovery of items other than as listed in §§B and C of this regulation. E. Both parties have a continuing duty to supplement their disclosures of witnesses and documents. F. Absent unforeseen circumstances which would otherwise impose an extraordinary hardship on a party, witnesses or documents may not be added to the list: (1) After the prehearing conference, if scheduled; or (2) Later than 15 days before the hearing, if a prehearing conference is not scheduled. G. The prohibition against adding witnesses does not apply to witnesses or documents to be used for impeachment or rebuttal purposes. H. All motions shall be accompanied by a memorandum of points and authorities and shall be filed with the Board at least 15 working days before the hearing. A copy shall be served on the opposing party. A response shall be filed with the Board at least 10 working days before the hearing and a copy served on the opposing party. The Board at its discretion will entertain motions on the day of the hearing. I. Construction. (1) In hearings conducted by an administrative law judge of the Office of Administrative Hearings, this regulation shall, whenever possible, be construed as supplementing and in harmony with COMAR 28.02.01. (2) In the event of a conflict between this regulation and COMAR 28.02.01, this regulation applies. #### Regulation .05 Conduct of the Hearing. *COMAR 10.36.03.05* A. Board Majority. Each hearing shall be held before a quorum of the Board unless the hearing authority is delegated pursuant to State Government Article, §10-205, Annotated Code of Maryland. A delegation of authority shall be subject to the provisions of State Government Article, §10-216, Annotated Code of Maryland. If hearing authority is not delegated, Board action shall be by a majority vote of those Board members present at the Board hearing. B. Duties of Presiding Officer. (1) Unless the Board's hearing authority is delegated, the Chairman, or a Board member designated by the Chairman, shall be the presiding officer. (2) The presiding officer shall: (a) Have complete charge of the hearing; (b) Permit the examination of witnesses; (c) Admit evidence; (d) Rule on the admissibility of evidence; (e) Adjourn or recess the hearing from time to time. (3) The presiding officer may set reasonable time limits on arguments and presentation of evidence. (4) The presiding officer shall be responsible for order in the hearing and can suspend the proceedings as necessary to maintain order. C. Legal Advisor and Counsel for the Board. (1) The presiding officer may request the Office of the Attorney General to participate in any hearing to present the case on behalf of the State. (2) The member of the Office of the Attorney General presenting the case on behalf of the State shall have all of the following rights: (a) The submission of evidence; (b) Examination and cross-examination of witnesses; (c) Presentation of summation and argument; and (d) Filing of objections, exceptions, and motions. (3) The presiding officer may also request a representative of the Office of the Attorney General to act as legal advisor to the Board on questions of procedure, evidence, and law. D. Order of Procedure. The case on behalf of the State shall be presented first. The respondent shall then present his case. After that, rebuttal shall be permitted. E. Examination of Witnesses and Introduction of Evidence. (1) The Board has the power to administer oaths and to compel the attendance of witnesses by subpoena. The Board shall issue subpoenas for any and all witnesses requested in writing by a party. (2) The rules of evidence in all hearings in this chapter shall be as set forth in State Government Article, §§10-213 and 10-214, Annotated Code of Maryland. (3) Each party has the right to: (a) Call witnesses and present evidence; (b) Cross-examine every witness called on behalf of the State or other party; (c) Present summation and argument and file objections, exceptions, and motions. (4) If a party is represented by counsel, the submission of evidence, examination, and cross-examination of witnesses, and filing of objections, exceptions, and motions shall be done and presented solely by that counsel. (5) After the direct testimony of the witness is presented and after cross-examination, the Board members may ask questions. (6) If an accused or complainant fails to appear at a hearing after due notice, the Board may reschedule the hearing, or at its discretion, proceed upon the investigation, report, documents, witnesses, and records before it. (7) At the end of the hearing any party may submit briefs of the issues of fact and law involved in the hearing, which briefs shall be filed in the form, with the number of copies, and at the time as the presiding officer may designate. #### Regulation .06 Records and Transcript. *COMAR 10.36.03.06* A. The Board shall prepare an official record which shall include all pleadings, testimony, exhibits, and other memoranda or material filed in the proceeding. B. A stenographic record of the proceedings shall be made at the expense of the Board. This record need not be transcribed, however, unless requested by a party, or by the Board. The cost of any typewritten transcripts of any proceedings, or part of them, shall be paid by the party requesting the transcript. #### Regulation .07 Decision and Order. *COMAR 10.36.03.07* A. Each decision and order rendered by the Board shall be in writing and shall be accompanied by findings of fact and conclusions of law. A copy of the decision and order and accompanying findings and conclusions shall be delivered or mailed promptly to each party or his attorney of record. In any order involving patients or clients of a psychologist or psychology associate these individuals will not be referred to by name if in the Board’s opinion confidentiality is in their best interests. B. If the psychologist or psychology associate is found not to be in violation of Health Occupations Article, Title 18, Annotated Code of Maryland, the Board immediately shall order a dismissal of the charges and the exoneration of the accused, and no further action may be taken by the Board on the charges involved. Upon a finding not in violation of Health Occupations Article, Title 18, the Board shall expunge the record of the proceedings. #### Regulation .08 Rehearings. *COMAR 10.36.03.08* A. Any party aggrieved by the decision and order may apply for rehearing within 10 days after service on him of the decision and order. The application shall state the grounds for rehearing. The Board shall grant or deny the application within 30 days of its submission to the Chairman of the Board. Action on the application shall lie at the discretion of the Board. B. Unless otherwise ordered, neither the rehearing nor the application for rehearing shall stay the enforcement of the order, or excuse the persons affected by it for failure to comply with its terms. C. On rehearing, the Board shall only consider facts not presented in the original hearing, including facts arising after the date of the original hearing, and may by new order abrogate, change, or modify its original order. #### Regulation .09 Appeal. *COMAR 10.36.03.09* Any person whose license or registration has been revoked or suspended by the Board, or any person placed on probation or reprimanded by the Board, may seek judicial review of the Board’s decision. This review shall be in accordance with the provisions of State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. ### Chapter 04 — Expungement of Board Records *Repealed* **Administrative History:** Effective date: December 10, 1990 (17:24 Md. R. 2837) **Administrative History:** Chapter repealed effective March 13, 1995 (22:5 Md. R. 367) ### Chapter 05 — Code of Ethics and Professional Conduct **Authority:** Health Occupations Article, §§1-212, 18-311, and 18-313(7), Annotated Code of Maryland **Administrative History:** Effective date: October 26, 1992 (19:21 Md. R. 1891) **Administrative History:** Regulation .05B amended effective June 26, 2000 (27:12 Md. R. 1140) **Administrative History:** Regulations .01 — .08 repealed and new Regulations .01 — .08 adopted effective November 10, 2003 (30:22 Md. R. 1582) **Administrative History:** Regulation .01 amended effective June 7, 2004 (31:11 Md. R. 857); May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .02B amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .03 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .04 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .05 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .06 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .08 amended effective May 25, 2015 (42:10 Md. R. 684) #### Regulation .01 Scope. *COMAR 10.36.05.01* This chapter governs the professional conduct of licensed psychologists, registered psychology associates, and applicants for both. #### Regulation .02 Definitions. *COMAR 10.36.05.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland Board of Examiners of Psychologists. (2) “Client” means the individual, couple, family, group, business, agency, school, organization, or association that the psychologist or psychology associate provides, or has provided, with professional services. (3) “Multiple relationship” means a relationship in which an individual is concurrently participating in two or more roles with another. (4) “Psychologist” means an individual who is licensed by the Board to practice psychology. (5) “Psychology associate” means an individual who is registered by the Board to practice psychology under the supervision of a psychologist. (6) “Public statement” means any oral, printed, or electronic communication or announcement made by or on behalf of a psychologist, psychology associate, or applicant, and directed to another individual or group. (7) “Sexual intimacies” means acts engaged in with or without clothing involving: (a) Genital contact; (b) Nongenital contact with the hips, loin, thigh, buttocks, or breasts; (c) Exposure or observation of genitals or nude portions of a body involving breasts, buttocks, or genitals; or (d) Other behaviors engaged in for the purpose of sexual arousal or sexual gratification. #### Regulation .03 Responsibilities and Requirements. *COMAR 10.36.05.03* A. In General. (1) A psychologist shall be fully responsible for the psychologist’s professional decisions and professional actions; (2) A psychologist and psychology associate shall be jointly responsible for the psychology associate’s professional decisions and professional actions. (3) A psychologist or psychology associate shall: (a) Notify the Board in writing within 60 days if a license, certificate, permit, or registration granted by another authority for the practice of psychology has been limited, restricted, suspended, revoked, or subjected to other disciplinary action by the particular licensing or granting authority; (b) Provide psychological services only in the context of clear professional and scientific relationships and roles accepted by the standard of practice of the discipline of psychology; (c) Make known the psychologist’s or psychology associate’s commitment to the Code of Ethics and Professional Conduct and resolve potential conflicts with the Code of Ethics and Professional Conduct in a responsible manner; (d) Treat all individuals in a fair and objective manner without discrimination based on age, gender, race, ethnicity, culture, national origin, disability, socioeconomic status, or another basis proscribed by law; (e) Interact with individuals in the workplace in a respectful manner without engaging in behavior that is harassing or demeaning; and (f) Comply with a Board order. (4) A psychologist or psychology associate may not: (a) Knowingly or willfully destroy, damage, alter, obliterate, or otherwise obscure a medical record or billing record or other information about a patient in an effort to conceal the information from use as evidence in an administrative, civil, or criminal proceeding; (b) Intimidate or influence an individual to withhold or change testimony in hearings or proceedings before the Board or those otherwise delegated to the Office of Administrative Hearings; (c) Hinder, prevent, or otherwise delay an individual from making information available to the Board in furtherance of an investigation of the Board; or (d) Take credit for work the psychologist or psychology associate has not actually performed or supervised. B. Supervision. A psychologist shall: (1) Be responsible for the actions of those the psychologist supervises; and (2) Ensure that those the psychologist employs act in accordance with the Maryland Psychologists Act and the provisions of this chapter. C. Research. A psychologist or psychology associate shall: (1) Respect the dignity and protect the welfare of research subjects, and comply with all relevant statutes, regulations, and institutional and administrative rules concerning treatment of research subjects; (2) Take responsibility for the ethical treatment of research participants by collaborators, supervisees, and employees; (3) Acquire, care for, use and dispose of animals in compliance with laws, regulations, and applicable professional standards; (4) Ensure appropriate consideration of the comfort, health and humane treatment of animals used in research; (5) Make clear, either as a researcher or a writer, the nature of the participation, as well as the costs and the psychologist's obligations to be accepted by research participants; (6) Obtain required approval from host institutions before conducting research; and (7) Report research findings accurately, presenting only the psychologist’s or psychology associate’s work or making appropriate citations when needed. D. Teaching. A psychologist or psychology associate shall ensure that statements in course catalogs, seminar brochures, and course outlines are accurate and not misleading, particularly in terms of the: (1) Subject matter to be covered; (2) Nature of course experiences; and (3) Basis for evaluating performance. #### Regulation .04 Competence. *COMAR 10.36.05.04* A. Professional Competence. A psychologist or psychology associate shall: (1) Limit practice to the areas of competence by which proficiency has been gained through education, training, and experience; (2) Acquire the special education and training needed to address the cultural differences of special populations; (3) Avoid unfair discrimination based on age, gender, race, ethnicity, culture, national origin, disability, socioeconomic status, or other basis proscribed by law; (4) Use interventions and assessment techniques only when the psychologist or psychology associate knows that the circumstances are appropriate applications of those interventions and techniques, supported by reliability, validation, standardization, and outcome studies; (5) Maintain competence by meeting the requirements of continuing education as set forth in COMAR 10.36.02; (6) Engage in ongoing consultation with other psychologists, psychology associates, or relevant professionals and seek appropriate education, training, and experience, when developing competence in a new service or technique; and (7) Document and maintain appropriate records of professional and scientific work. B. Impaired Competence. (1) A psychologist or psychology associate shall: (a) Represent accurately and objectively the psychologist’s or psychology associate’s professional qualifications; and (b) Seek competent professional assistance to determine whether to suspend, terminate, or limit the scope of professional or scientific activities when the psychologist or psychology associate becomes or is made aware that the psychologist’s or psychology associate’s competence is impaired. (2) A psychologist or psychology associate may not: (a) Undertake or continue a professional relationship with a client when the competence or objectivity of the psychologist or psychology associate is or could reasonably be expected to be impaired due to: (i) Mental, emotional, physiological, pharmacological, substance abuse, or personal problems; or (ii) The psychologist’s or psychology associate’s present or previous familial, social, sexual, emotional, financial, supervisory, political, administrative, or legal relationship with the client or a person associated with or related to the client; or (b) Engage in other relationships that could limit the psychologist’s or psychology associate’s objectivity or create a conflict of interest or the appearance of a conflict of interest. #### Regulation .05 Representation of Services and Fees. *COMAR 10.36.05.05* A. Public Statements and Advertising. (1) A psychologist or psychology associate shall: (a) Represent accurately and objectively the psychologist’s or psychology associate’s professional qualifications, education, experience, and areas of competence; (b) Correct others who misrepresent the psychologist’s or psychology associate’s professional qualifications or affiliations; and (c) Identify a paid advertisement as a paid advertisement. (2) A psychologist or psychology associate may not: (a) Misrepresent, directly or by implication, the affiliations or the purposes or characteristics of institutions and organizations with which the psychologist or psychology associate is affiliated; (b) Claim organizational membership in a manner that suggests specialized competence or qualifications that the psychologist or psychology associate does not have; (c) Make public statements that contain: (i) False, fraudulent, misleading, or deceptive statements; (ii) Partial disclosures of relevant facts that misrepresent, mislead, or deceive; or (iii) Statements that create false or unjustified expectations of favorable results; or (d) Solicit, either in person or through others, business or testimonial endorsements from clients who are vulnerable to undue influence. B. Informed Consent. When conducting research or providing assessment, psychotherapy, counseling, or consulting with an individual or organization in person or by electronic transmission or other forms of communication, a psychologist or psychology associate shall: (1) In general: (a) Obtain informed consent using appropriate language understandable to the client; (b) Vary appropriate informed consent forms and procedures to ensure that the client: (i) Has the capacity to consent; (ii) Has been provided with information concerning participation in the activity that reasonably might affect the willingness to participate, including limits of confidentiality and monetary costs or reimbursements; (iii) Is aware of the voluntary nature of participation and has freely and without undue influence expressed consent; and (iv) Is given the opportunity to ask questions and receive answers regarding the activity; (2) In research, make clear to the client: (a) The nature of the participation as well as the costs and other obligations to be accepted by research participants; (b) The purpose and nature of any evaluations, treatment, or educational or training procedure; (c) All aspects of research including any risks and consequences of the research that will reasonably be expected to influence willingness to participate; (d) The right to withdraw from treatment or research at any time; and (e) The notification that permission shall be given by the client, student, or research participant before the use of observation or electronic taping, recording, or filming procedures; and (3) In therapeutic relationships, explain to the client: (a) The clarification of reasonable expectations; (b) The nature and purpose of testing, reports, and consultations; (c) The limits of confidentiality; (d) Specific information concerning fees, billing, and electronic services available in the payment of fees; (e) Psychotherapeutic schedules; and (f) The process and conditions of termination of therapy. C. Financial Arrangements and Fees. A psychologist or psychology associate shall: (1) Make advance financial arrangements that are clearly understood by the client; (2) Inform the client about the possibility of initiating a collection procedure before using that procedure; (3) Comply with the provisions regarding patient referrals contained in Health Occupations Article, §§1-301 — 1-306, Annotated Code of Maryland; (4) Make full disclosure in advance to the client of any remuneration given or received for making or accepting referrals; and (5) Refrain from signing statements for insurance purposes as though the psychologist or psychology associate provided a service that was actually provided by someone else. #### Regulation .06 Psychological Assessment. *COMAR 10.36.05.06* A. A psychologist or psychology associate shall: (1) Perform evaluations and diagnostic services in a professional relationship when assessment data is indicated by the professional context; (2) Administer psychological tests in keeping with accepted standards of practice and avoid use of obsolete measurement techniques; (3) Use appropriate or specialized assessment instruments when working with individuals from special populations; (4) Use appropriate scoring devices, norms, and standards in evaluating test protocols; (5) Select scoring and interpretive programs and services on the basis of evidence of the validity of the programs and procedures; (6) Report the results of assessment procedures by: (a) Using adequate interpretative aids or explanations; (b) Including any deficiencies of the assessment norms for the individual assessed, and any relevant reservations or qualifications which affect the validity, reliability, or other interpretation of results; and (c) Avoiding misuse of automated interpretative reports; (7) Base recommendations or decisions on test results that are reasonably current and not obsolete; (8) Supply a manual or other printed material which fully describes the development of the assessment procedure or service, the rationale, evidence of validity and reliability, and characteristics of the normative population when offering an assessment procedure or automated interpretation service to other professionals; and (9) Release test results only to patients and clients as appropriate. B. A psychologist or psychology associate may not: (1) Release test protocols or raw data to persons who are not qualified to interpret and use the information appropriately, except as required by law; (2) Encourage or promote the use of psychological assessment techniques or computerized assessment and interpretation by unqualified persons; or (3) Reproduce test materials or describe psychological tests or other assessment devices in popular publications, lectures, or public presentation in ways that might compromise their validity. #### Regulation .07 Client Welfare. *COMAR 10.36.05.07* A. A psychologist or psychology associate shall: (1) Take appropriate steps to disclose to all involved parties conflicts of interest that arise, with respect to a psychologist’s or psychology associate’s clients, in a manner that is consistent with applicable confidentiality requirements; and (2) Make arrangements for another appropriate professional to deal with emergency needs of the psychologist’s or psychology associate’s clients as appropriate, during periods of anticipated absences from professional availability. B. Exploitation. A psychologist or psychology associate may not: (1) Exploit or harm clients, colleagues, students, research participants, or others; (2) Take actions that violate or diminish the legal and civil rights of clients or of others who may be affected by the action; (3) Exploit the trust and dependency of clients, students, and subordinates; (4) Allow personal, social, religious, organizational, financial, or political situations and pressures to lead to a misuse of their influence; or (5) Enter into a new nonpsychological, nonprofessional relationship with a former client that is considered exploitative dependent on, but not limited to: (a) The nature, duration, and intensity of professional services rendered to the client; (b) The length of the professional relationship; (c) The length of time between the termination of the professional relationship and the initiation of the nonprofessional relationship; (d) The mental stability of the psychologist or psychology associate and former client; (e) The circumstances of termination, including, but not limited to, statements or actions of the psychologist or psychology associate suggesting or inviting the possibility of a post-termination relationship; and (f) The likelihood of adverse impact on the client. C. Sexual Misconduct. A psychologist or psychology associate may not: (1) Engage in sexual intimacies with a current client; (2) Engage in sexual intimacies with a former client: (a) For at least 2 years after the cessation or termination of professional services; or (b) After the 2 years following the cessation or termination of professional services if the sexual relationship is exploitative in light of the following factors: (i) The nature, duration, and intensity of professional services rendered to the client; (ii) The length of the professional relationship; (iii) The length of time between the termination of the professional relationship and the initiation of the nonprofessional relationship; (iv) The mental stability of the psychologist or psychology associate and former client; (v) The circumstances of termination including, but not limited to, statements, or actions of the psychologist or psychology associate suggesting or inviting the possibility of a post-termination sexual or romantic relationship; and (vi) The likelihood of adverse impact on the former client; (3) Engage in sexual intimacies with individuals known to be the parents, guardians, spouses, domestic partners, sexual partners, children, or siblings of the client or for at least 2 years after cessation or termination of professional services; (4) Terminate a professional relationship with a client for the purpose of engaging in sexual intimacies with one of the individuals set forth in §C(3) of this regulation; (5) Engage in sexual behavior with a client in the context of a professional evaluation, treatment, procedure, or service to the client, regardless of the setting in which the professional service is rendered; or (6) Engage in sexual behavior with a client under the pretext of diagnostic or therapeutic intent or benefit. D. Harassment. A psychologist or psychology associate may not: (1) Engage in sexual solicitation, physical advances, or verbal or nonverbal conduct that is sexual in nature, which behavior occurs in connection with the psychologist’s or psychology associate’s professional role; (2) Engage in sexual harassment of the psychologist’s or psychology associate’s past or present clients, supervisees, research participants, or employees, with deliberate or repeated comments, gestures, or physical contacts of a sexual nature; or (3) Create a hostile workplace or educational environment by unwelcome and offensive behaviors that are sufficiently severe or intense to be abusive of a reasonable individual in that environment whether it consists of a single act or of multiple persistent or pervasive acts. E. A psychologist or psychology associate shall: (1) Provide psychological services for minor children or for adults who have legal guardians only with appropriate authorization; and (2) Take special care to protect the interests of minors or clients who are unable to give voluntary, informed consent. F. Termination of Services. A psychologist or psychology associate shall: (1) Make or recommend referral to other professional, technical, or administrative resources if the referral is clearly in the best interest of the client; and (2) Unless precluded by the actions of the client, terminate the professional relationship in an appropriate manner, notify the client in writing of this termination, and assist the client in obtaining services from another professional, if: (a) It is reasonably clear the client is not benefiting from the relationship; (b) A multiple relationship develops or is discovered after the professional relationship has been initiated; (c) Impaired competency or objectivity develops or is discovered after a professional relationship has been initiated; or (d) The psychologist or psychology associate has been threatened or otherwise endangered by the client or another person with whom the client has a relationship. #### Regulation .08 Confidentiality and Client Records. *COMAR 10.36.05.08* A. A psychologist or psychology associate shall: (1) Maintain confidentiality regarding information obtained from a client in the course of the psychologist’s or psychology associate’s work; (2) Discuss the requirements and limitations of confidentiality at the beginning of the professional relationship or at the intake interview; (3) Safeguard information obtained in clinical or consulting relationships or evaluative data concerning children, students, employees, and others obtained in the course of practice, teaching, research, or other professional services; (4) Release mental health records or other confidential information only as permitted or required by law; (5) Obtain written permission for the electronic recording of interviews; (6) Avoid undue invasion of privacy by ensuring that written and oral reports contain only data relevant to the purpose of the evaluation; (7) Treat any assessment result or interpretation regarding an individual as confidential information; and (8) Obtain informed written consent before presenting in writing, lecture, or other public forums identifying information obtained during the course of professional work, and disguise this information when case reports or other confidential information are used as a basis for teaching or research. B. Legal and Ethical Limits. A psychologist or psychology associate shall inform: (1) Clients of the legal and ethical limits of confidentiality; (2) Clients below the age of minority, or who have legal guardians, of the limits the law imposes on the right of confidentiality with respect to communications with the psychologist or psychology associate, to the extent that the client can understand, at the beginning of the professional relationship; (3) Research participants of any limits to confidentiality as part of the informed consent; and (4) Clients of the duty imposed by law to inform authorities of abuse and neglect of children and vulnerable adults. C. Record Keeping. A psychologist or psychology associate shall: (1) Keep records of a patient's condition and assessment results; (2) Maintain clinical records of informed consent, presenting problems, diagnosis, fee arrangements, dates and substance of each billed service, original test data with results and other evaluative material, and the results of any formal consultations with other professionals; (3) Make provisions for maintaining confidentiality in the storage and disposal of written and electronic records; (4) Ensure that professional records are maintained for a period consistent with State and federal laws; (5) Limit access to client records and ensure that a person working under the psychologist’s or psychology associate’s authority including, but not limited to office personnel, comply with the requirements for confidentiality of client material; and (6) Provide evaluations or treatment reports within a reasonable time consistent with State and federal laws on proper and lawful requests by a client, insurance carrier, court, institution, or other authorized health provider. ### Chapter 06 — Fee Schedule **Authority:** Health Occupations Article, §§18-206, 18-207, 18-301, and 18-310, Annotated Code of Maryland **Administrative History:** Effective date: October 26, 1992 (19:21 Md. R. 1892) **Administrative History:** Regulation .02 amended as an emergency provision effective December 17, 2001 (29:1 Md. R. 18); amended permanently effective March 18, 2002 (29:5 Md. R. 504) **Administrative History:** Regulation .02 amended effective March 21, 2011 (38:6 Md. R. 395); May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .02C amended effective September 27, 1993 (20:19 Md. R. 1472); September 20, 1999 (26:19 Md. R. 1448); August 6, 2001 (28:15 Md. R. 1397) **Administrative History:** Regulation .02F amended effective September 27, 1993 (20:19 Md. R. 1472) **Administrative History:** Regulation .02L adopted effective December 12, 2013 (40:24 Md. R. 2017) **Administrative History:** Regulation .05 adopted effective September 20, 1999 (26:19 Md. R. 1448) **Administrative History:** Regulation .06 adopted effective September 20, 1999 (26:19 Md. R. 1448) #### Regulation .01 Scope. *COMAR 10.36.06.01* These regulations govern all those licensed or applying for licensure by the Board, or registering as a psychology associate. #### Regulation .02 Fees. *COMAR 10.36.06.02* The following fees are established by the Board: A. Licensure application fee — $300; B. Psychology associate registration application fee — $200; C. Examination fees: (1) National examination — $650; (2) State examination — $250; D. Verification of licensure or registration — $20; E. Biennial licensure renewal fee — $400; F. Biennial registration renewal fee — $300; G. Late fee — $50; H. Inactive status fee (every 2 years) — $200; I. Reinstatement fee for license — $700; J. Reinstatement fee for registration — $600; K. Penalty for returned check — $50; L. Duplicate license or registration: (1) Wall certificate — $50; (2) Wallet card — $30; M. Temporary Exception to Practice — $100. N. Roster of licensed psychologists or registered psychology associates — $150. #### Regulation .03 Refunds. *COMAR 10.36.06.03* Application fees are nonrefundable. Examination fees shall be refunded if the request to cancel an examination is received in writing 2 weeks before the examination date. #### Regulation .04 Change of Fees. *COMAR 10.36.06.04* Fees are subject to change by action of the Board of Examiners of Psychologists. Licensees and applicants shall be notified of the change. #### Regulation .05 One-Time Transitional Annual Licensure Renewal Fee. *COMAR 10.36.06.05* For licensure renewal due between January 1 and March 31, 2000, a licensee whose license number is an odd number shall submit one-half of the biennial renewal fee for a 1-year license. #### Regulation .06 Assessment for Health Care Professionals. *COMAR 10.36.06.06* The Maryland Health Care Commission (MHCC) assesses a fee for health care professionals which the applicant shall pay at the time of license renewal as specified in COMAR 10.25.02. ### Chapter 07 — Psychology Associate **Authority:** Health Occupations Article, §§18-101, 18-206, and 18-301, Annotated Code of Maryland **Administrative History:** Effective date: September 25, 1995 (22:19 Md. R. 1473) **Administrative History:** Regulations .05 — .07 amended effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulation .07 amended effective March 21, 2011 (38:6 Md. R. 395) **Administrative History:** Regulations .01 — .07 repealed and new Regulations .01 — .06 adopted effective May 25, 2015 (42:10 Md. R. 684) #### Regulation .01 Scope. *COMAR 10.36.07.01* This chapter applies to: A. Registered psychology associates; and B. Licensed psychologists who supervise psychology associates. #### Regulation .02 Definitions. *COMAR 10.36.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Examiners of Psychologists. (2) “Full-time” means the provision of psychological services through direct client contact at least 26 hours per week. (3) “Registered psychology associate” means an individual who meets the requirements set forth in the Maryland Psychologists Act and is registered by the Board to practice psychology under the supervision of a licensed psychologist. (4) “Supervisor” means a psychologist licensed in Maryland with at least 2 years of post-licensure experience who supervises a registered psychology associate. #### Regulation .03 Responsibilities of Supervisors. *COMAR 10.36.07.03* A. Requirements of the Supervisory Relationship. (1) A supervisor of a registered psychology associate shall supervise only in those areas within the supervisor’s competence as determined by education, training, and experience. (2) A supervisor shall ensure that a registered psychology associate is practicing within the scope of the registered psychology associate’s competence as demonstrated by the registered psychology associate’s documented education, training, and experience in the particular practice area. (3) A supervisor: (a) May delegate some supervisory responsibilities to another psychologist licensed by the Board to: (i) Ensure competent supervision of a registered psychology associate in areas outside the area of expertise of the supervisor; or (ii) Provide temporary supervision when the supervisor is unavailable; and (b) Shall: (i) Document the delegated supervision in accordance with Regulation .05B(1) of this chapter; and (ii) Continue to assume responsibility for the psychological services and activities performed by the registered psychology associate during the period in which supervisory responsibilities have been delegated. (4) Adequate and appropriate supervision shall be determined by the: (a) Education, training, and experience of the registered psychology associate; (b) Nature and extent of services performed by the registered psychology associate; and (c) Setting in which the services are performed. (5) Adequate and appropriate supervision for full-time provision of psychological services by each registered psychology associate shall consist of: (a) One hour or more per week for a registered psychology associate who has earned a doctoral degree in psychology; (b) Two hours or more per week for a registered psychology associate who has been admitted to a candidacy for a doctoral degree in clinical psychology, counseling psychology, school psychology, or education with a field of specialization in psychology or counseling psychology in a program accredited by the Council for Higher Education, who has satisfactorily: (i) Completed at least 3 years of postgraduate education in psychology; and (ii) Passed preliminary doctoral examinations; or (c) Three hours or more per week for all other registered psychology associates. (6) In addition to the requirements set forth in §A(5) of this regulation, adequate supervision of a registered psychology associate shall include a minimum of 1 hour of supervision for every 5 hours of comprehensive evaluation and testing of a client. (7) The amount of supervision required by §A(5) and (6) of this regulation: (a) May be reduced by one-half for a registered psychology associate who has had 3 years of full-time experience, or its equivalent, as a psychology associate; and (b) May be reduced proportionately for a registered psychology associate who provides services less than full-time. (8) Adequate and appropriate supervision shall be: (a) Provided to a registered psychology associate at a face-to-face meeting, which may include videoconferencing, unless granted an exemption by the Board; and (b) Exclusive of supervision on administrative issues. (9) If the supervisor is not practicing at the same site as the registered psychology associate, the supervisor shall conduct quarterly site visits at the location where the registered psychology associate is providing services,. (10) The registered psychology associate shall inform the supervisor of all complaints, regardless of nature or origin, related to conduct of or services provided by the registered psychology associate. B. Termination of the Supervisory Relationship. (1) Either party to the supervisory relationship may terminate the supervisory relationship. (2) In the event of a termination of a supervisory relationship, the registered psychology associate may only continue to practice psychology under the supervision of another licensed psychologist who meets the requirements of this chapter. (3) The registered psychology associate and the supervisor in the terminated supervisory relationship shall submit notice of the termination to the Board in accordance with Regulation .06 of this chapter. C. Responsibilities of the Supervisor. (1) A supervisor shall be available for emergency consultation and direction of a registered psychology associate, and for client management. (2) A supervisor may supervise a maximum of five registered psychology associates. (3) A supervisor may not engage in supervision that would constitute a multiple relationship. (4) A supervisor shall take responsibility for all services provided by a registered psychology associate under the supervisor’s supervision. (5) A supervisor shall comply with additional continuing education requirements for supervisors set forth in COMAR 10.36.02. #### Regulation .04 Representations to the Public. *COMAR 10.36.07.04* A. A registered psychology associate: (1) Shall make personal reference as a “registered psychology associate under the supervision of a licensed psychologist” in all promotional materials and other communications relating to the provision of psychological services; and (2) May not make personal reference as a psychologist, either orally or in writing. B. A supervisor or registered psychology associate shall inform all clients of the supervision arrangement and its possible implications for insurance reimbursement and confidentiality. C. A supervisor and registered psychology associate shall ensure that those who are billed for services by the registered psychology associate are informed that the registered psychology associate provided the services under the supervision of a licensed psychologist. D. A registered psychology associate may not engage in, or give the appearance of, practicing psychology independently of the supervisor. #### Regulation .05 Recordkeeping. *COMAR 10.36.07.05* A. The recordkeeping requirements of this regulation are in addition to the recordkeeping requirements in COMAR 10.36.05. B. Supervisory Sessions. (1) A supervisor and registered psychology associate shall maintain appropriate documentation of the nature and extent of the supervision provided or delegated, including the: (a) Dates and duration of supervisory sessions; (b) Client names or other identification for all cases; (c) Outcome of each case reviewed; (d) Signatures of both the supervisor and registered psychology associate; and (e) Reason for any delegation of supervisory responsibility. (2) A supervisor and registered psychology associate shall provide documentation of supervisory sessions upon request by the Board. (3) Documentation of the supervisory sessions shall be maintained by the supervisor and registered psychology associate for at least 5 years. C. Clinical Records. (1) A registered psychology associate shall have the supervisor co-sign all clinical documents, including: (a) Evaluations; (b) Authorizations for release; (c) Treatment plans; and (d) Report. (2) Except as otherwise required, after the initial entry of the supervisor’s name and license number in a client file or medical record, a registered psychology associate may omit repetitive references to the supervisor. (3) Routine entries made by a registered psychology associate do not have to be cosigned by the supervisor, unless failure to do so would result in a misrepresentation of the services provided. D. Documentation of site visits shall be maintained by the supervisor and the registered psychology associate for at least 5 years, and shall include: (1) Date and time of visit; (2) Site location; and (3) Any issues or concerns relating to the registered psychology associate’s provision of services at the site. #### Regulation .06 Board Review and Reporting Requirements. *COMAR 10.36.07.06* A. The supervisory relationship is subject to review by the Board. B. At the time of renewal of the supervisor, the supervisor shall submit to the Board a list of all registered psychology associates supervised by the supervisor on a form approved by the Board that includes the beginning and ending dates of supervision for each registered psychology associate: (1) Supervised during the previous licensure period; and (2) Currently being supervised. C. At the time of renewal of the registered psychology associate, the registered psychology associate shall submit to the Board the name and license number of any supervisors who provided supervision to the registered psychology associate: (1) During the previous registration period; and (2) During the present registration period. D. A supervisor and registered psychology associate shall immediately report to the Board in writing the date of termination of the supervisory relationship. E. A registered psychology associate shall immediately report in writing to the Board any change of supervisor or addition of a supervisor. ### Chapter 08 — Disciplinary Sanctions, Monetary Penalties, and Civil Fines **Authority:** Health Occupations Article, §§1-606, 18-313, 18-313.1, and 18-404, Annotated Code of Maryland **Administrative History:** Effective date: October 2, 2000 (27:19 Md. R. 1726 **Administrative History:** Regulations .01 — .06 repealed and new Regulations .01 — .06 adopted effective February 20, 2012 (39:3 Md. R. 259) **Administrative History:** Regulation .02B amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .03 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .04 amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .05A amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .06A, C amended effective May 25, 2015 (42:10 Md. R. 684) **Administrative History:** Regulation .06E repealed effective March 17, 2014 (41:5 Md. R. 347) **Administrative History:** Regulation .07 adopted effective March 17, 2014 (41:5 Md. R. 347) **Administrative History:** Regulation .07 amended effective May 25, 2015 (42:10 Md. R. 684) #### Regulation .01 Scope. *COMAR 10.36.08.01* This chapter establishes standards for the imposition of sanctions and monetary penalties for violations of the Maryland Psychologists Act. #### Regulation .02 Definitions. *COMAR 10.36.08.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the State Board of Examiners of Psychologists. (2) “License” means a license issued by the Board to practice psychology. (3) “Licensee” means a psychologist who is licensed by the Board to practice psychology. (4) “Penalty” means monetary penalty. (5) “Registrant” means a psychology associate who is registered by the Board to practice psychology under the supervision of a licensed psychologist. (6) “Registration” means a registration issued by the Board to practice psychology under the supervision of a licensed psychologist. (7) “Sanction” means a formal disciplinary action against a license such as a reprimand, probation, suspension, or revocation. #### Regulation .03 Imposition of a Penalty After a Hearing. *COMAR 10.36.08.03* If the Board finds that there are grounds under Health Occupations Article, §18-313, Annotated Code of Maryland, to suspend or revoke a license or registration or to reprimand a licensee or registrant, the Board may impose a penalty as set forth in this chapter: A. Instead of suspending the license or registration; or B. In addition to suspending or revoking the license or registration. #### Regulation .04 Guidelines for Disciplinary Sanctions and Imposition of Penalties. *COMAR 10.36.08.04* A. Subject to the provisions of this chapter, the Board may impose sanctions and penalties for violations of the Maryland Psychologists Act and its regulations according to the guidelines set forth in the following categories: B. If a licensee or registrant is found in violation of more than one category enumerated in this regulation, the category or categories containing the highest maximum sanction and penalty shall control. C. Notwithstanding the guidelines set forth in this regulation, in order to resolve a pending disciplinary action, the Board and licensee or registrant may agree to a surrender of a license or registration or to a consent order with terms, sanction, and penalty agreed to by the Board and the licensee or registrant. D. A departure from the guidelines set forth in this regulation alone is not grounds for any hearing or appeal of a Board action. #### Regulation .05 Mitigating and Aggravating Factors to Be Considered in the Assessment of the Sanction. *COMAR 10.36.08.05* A. Depending on the facts and circumstances of each case, and to the extent that they apply, the Board may consider the following mitigating and aggravating factors in determining whether the sanction in a particular case should fall outside the range of sanctions established by the guidelines. These factors may include, but are not limited to, the following: (1) Mitigating Factors: (a) The licensee’s or registrant’s lack of a prior disciplinary record; (b) The licensee or registrant self-reported the violation to the Board; (c) The licensee’s or registrant’s full and voluntary admissions of misconduct to the Board and cooperation during Board proceedings; (d) Implementation of remedial measures to correct or mitigate harm arising from the misconduct; (e) Timely good-faith effort to make restitution or to rectify consequences of misconduct; (f) Evidence of rehabilitation or rehabilitative potential; (g) Absence of premeditation to commit the misconduct; (h) Absence of potential harm to public or adverse impact; (i) The licensee’s or registrant’s conduct was an isolated incident and not likely to recur; and (2) Aggravating Factors: (a) The licensee or registrant has a previous criminal or administrative disciplinary history; (b) The violation was committed deliberately or with gross negligence or recklessness; (c) The violation had the potential for, or caused, serious patient or public harm; (d) The violation was part of a pattern of detrimental conduct; (e) The licensee or registrant was motivated to perform the violation for financial gain; (f) The vulnerability of the patient or patients; (g) The licensee or registrant lacked insight into the wrongfulness of the conduct; (h) The licensee or registrant committed the violation under the guise of treatment; and (i) Previous attempts at rehabilitation of the licensee or registrant were unsuccessful. B. The existence of one or more of these factors does not impose on the Board or an Administrative Law Judge any requirement to articulate its reasoning for not exercising its discretion to impose a sanction outside of the range of sanctions set forth in this chapter. C. Nothing in this regulation requires the Board or an Administrative Law Judge to make findings of fact with respect to any of these factors. #### Regulation .06 Payment of a Penalty. *COMAR 10.36.08.06* A. A licensee or registrant shall pay to the Board a penalty imposed under this chapter as of the date the Board’s order is issued, unless the Board’s order specifies otherwise. B. Filing an appeal under State Government Article, §10-222, Annotated Code of Maryland, or Health Occupations Article, §18-316, Annotated Code of Maryland, does not automatically stay payment of a penalty imposed by the Board under this chapter. C. If a licensee or registrant fails to pay, in whole or in part, a penalty imposed by the Board under this chapter, the Board may not restore, reinstate, or renew a license or registration until the penalty has been paid in full. D. In its discretion, the Board may refer all cases of delinquent payment to the Central Collection Unit of the Department of Budget and Management to institute and maintain proceedings to ensure prompt payment. #### Regulation .07 Civil Fines. *COMAR 10.36.08.07* A. Practicing on an Expired License or Registration. (1) The Board may impose a civil fine against a psychologist or psychology associate who practices psychology on an expired license or registration in the amount of $100 per day of practice past the expiration date of the license or registration. (2) The Board may not impose a fine under §A(1) of this regulation against a psychologist or psychology associate for practicing psychology on an expired license or registration if the psychologist’s license or the psychology associate’s registration is reinstated within 30 calendar days of the expiration date of the license or registration and the licensee or registrant complies with COMAR 10.36.02.08B. B. Practicing Without a License or Registration. (1) The Board may impose a civil fine of no less than $5,000 and no more than $50,000 against an individual who practices psychology without a license or registration. (2) Factors determining the amount of the fine shall include, but not be limited to, the following: (a) The extent to which the individual derived any financial benefit from the unauthorized practice; (b) The willfullness of the unauthorized practice; (c) Actual or potential harm caused by the unauthorized practice; and (d) The length of time in which the individual engaged in the unauthorized practice. ### Chapter 09 — Child Custody Evaluations in Family Law Proceedings **Authority:** Health Occupations Article, §18-206, Annotated Code of Maryland **Administrative History:** Effective date: August 22, 2011 (38:17 Md. R. 1013) #### Regulation .01 Scope. *COMAR 10.36.09.01* A. This chapter governs the professional conduct of licensed psychologists who are performing child custody evaluations or who otherwise render an opinion on legal or physical custody. B. This chapter is not intended to negate the psychologist’s obligations to comply with other provisions of this subtitle. C. This chapter does not apply to the following types of proceedings: (1) Child in need of assistance (CINA) proceedings in accordance with Courts and Judicial Proceedings Article, Title 3, Subtitle 8, Annotated Code of Maryland; (2) Department of Juvenile Services proceedings in accordance with Courts and Judicial Proceedings Article, Title 3, Subtitle 8A, Annotated Code of Maryland; or (3) Termination of parental rights (TPR) proceedings in accordance with Family Law Article, Title 5, Subtitle 3, Annotated Code of Maryland. #### Regulation .02 Definitions. *COMAR 10.36.09.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Child” means an individual younger than 18 years old. (2) “Child custody evaluation” means an assessment performed by a psychologist in order to render findings and recommendations regarding custody or visitation that are in the best interest of a child. (3) “Child Custody Proceeding” means a proceeding in which legal custody, physical custody, or visitation with respect to a child is an issue. #### Regulation .03 Preparing for a Child Custody Evaluation. *COMAR 10.36.09.03* Before performing a child custody evaluation, a psychologist shall: A. Obtain a copy of: (1) The court order; or (2) An agreement signed by the parties; B. Review the scope of the evaluation as defined by the court’s order or the signed agreement and insure that the order or agreement is consistent with the provisions of this chapter; and C. Obtain the necessary signed informed consent from the parties, which shall include: (1) The scope of the custody evaluation; (2) The process for conducting the child custody evaluation; (3) Limits to confidentiality; (4) The basis and rate of fees and expenses for which the client will be responsible; and (5) The timeline on which payments are due to the psychologist. #### Regulation .04 Competence Necessary to Conduct Child Custody Evaluations. *COMAR 10.36.09.04* A. To be considered competent to conduct child custody evaluations, a psychologist shall have education, training, experience, or supervision in the following areas: (1) Child and adult development and psychopathology; (2) Family dynamics and psychopathology, including the impact of divorce; (3) Maryland law governing: (a) Divorce; (b) Child custody proceedings; (c) Child abuse and neglect; and (d) Family violence; and (4) Performing psychological assessments of: (a) Children; (b) Adults; and (c) Families. B. A psychologist conducting a child custody evaluation shall have competence to effectively address common issues that may arise in conducting child custody evaluations such as: (1) Age; (2) Disability; (3) Ethnicity; (4) Gender; (5) Gender identity; (6) Language; (7) National origin; (8) Race; (9) Religion; (10) Culture; (11) Sexual orientation; and (12) Socioeconomic status. C. A psychologist shall have an awareness of the literature relevant to conducting child custody evaluations. #### Regulation .05 Standards of Practice in Conducting a Child Custody Evaluation. *COMAR 10.36.09.05* A. In order to determine legal and physical custody arrangements that serve the child’s best interests, a psychologist conducting a child custody evaluation shall: (1) Assess the following: (a) Parenting skills and capacities of the adults; and (b) The child’s psychological functioning and developmental needs; (2) Use multiple methods of data gathering, including, but not limited to: (a) Individually interviewing and assessing each party and each child, if age appropriate; (b) Observing the interactions of the child with each parental figure, in the respective households, whenever possible; and (c) Requesting and assessing additional relevant information whenever possible, such as: (i) Third-party interviews; (ii) Medical records; (iii) School records; and (iv) Legal documents; (3) Remain impartial and objective; (4) Interpret assessment data and clinical information in a manner consistent with current standards of practice; (5) Base recommendations on the needs and best interests of the child, as supported by the: (a) Evaluation data; and (b) Applicable law; (6) Create and maintain professional records in accordance with COMAR 10.36.05; (7) Include appropriate disclaimers regarding the limitations of the recommendations, such as: (a) Unavailability of information; (b) Lack of cooperation of the parties; (c) Lack of compliance with court orders; or (d) Inconclusive assessment data; and (8) Decline to conduct the evaluation as set forth in COMAR 10.36.05 if the psychologist feels that the psychologist’s objectivity would be impaired. B. In the event a psychologist determines sufficient information is not available, the psychologist may decline to make recommendations. C. A psychologist performing a child custody evaluation may not: (1) Engage in multiple relationships with any of the parties to the pending child custody proceeding, including serving as a: (a) Mediator; (b) Therapist; (c) Life coach; (d) Parenting coordinator; or (e) Litigation consultant; or (2) Render an opinion concerning the psychological functioning or custodial fitness of a individual involved in the custody proceeding who has not been personally evaluated by the psychologist during the current child custody evaluation. ### Chapter 10 — Telepsychology **Authority:** Health Occupations Article, §§1-901—1-903, Annotated Code of Maryland **Administrative History:** Effective date: May 20, 2019 (46:10 Md. R. 489) #### Regulation .01 Scope. *COMAR 10.36.10.01* This chapter applies to all psychologists and psychology associates in Maryland who engage in the practice of psychology using telepsychology. #### Regulation .02 Definitions. *COMAR 10.36.10.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Maryland Board of Examiners of Psychologists. (2) “Client” means the individual, couple, family, group, business, agency, school, organization, or association that the psychologist or psychology associate provides, or has provided, with professional services. (3) “Psychologist” means an individual who is licensed by the Board to practice psychology. (4) “Psychology associate” means an individual who is registered by the Board to practice psychology under the supervision of a licensed psychologist. (5) Telepsychology. (a) “Telepsychology” means the use of interactive audio, video, or other telecommunications or electronic media by a psychologist or psychology associate who engages in the practice of psychology at a location other than the location of the client. (b) “Telepsychology” does not include: (i) An audio-only telephone conversation between a psychologist or psychology associate and a client; (ii) An electronic mail message between a psychologist or psychology associate and a client; (iii) A facsimile transmission between a psychologist or psychology associate and a client; or (iv) A text message or other type of message sent between a psychologist or psychology associate and a client by a short message service or multimedia messaging service. #### Regulation .03 Licensure. *COMAR 10.36.10.03* An individual shall be licensed with the Board as a psychologist or registered with the Board as a psychology associate in order to engage in the practice of psychology using telepsychology in Maryland if one or both of the following occurs: A. The individual practicing telepsychology is physically located in Maryland: or B. The client is in Maryland. #### Regulation .04 Standards of Practice for Telepsychology. *COMAR 10.36.10.04* A. Before providing telepsychology services, a psychologist or psychology associate shall develop and follow a procedure to: (1) Verify the identification of the client receiving telepsychology services; (2) Obtain informed consent specific to telepsychology services using appropriate language understandable to the client; (3) Prevent access to data by unauthorized persons through encryption, or other means; (4) Notify clients in the event of a data breach; (5) Ensure that the telepsychology practitioner provides a secure and private telepsychology connection and complies with federal and state privacy laws; (6) Establish safety protocols to be used in the case of an emergency, including contact information for emergency services at the client’s location; and (7) Ensure that any psychological testing instruments used are designed, validated, or appropriate for use via telepsychology. B. A psychologist or psychology associate shall: (1) Obtain or confirm an alternative method of contacting the client in case of a technological failure; (2) Determine whether the client is in Maryland and identify the client’s specific location; (3) For an initial telepsychology interaction only, disclose the psychologist’s or psychology associate’s name, location, license number, and contact information; (4) Identify all individuals present at each location and confirm they are permitted to hear the client’s health information; and (5) Be held to the same standards of practice and documentation as those applicable for in-person sessions. C. A psychologist or psychology associate may not treat a client based solely on an online questionnaire. #### Regulation .05 Evaluation for Telepsychology Services. *COMAR 10.36.10.05* A. Before engaging in the practice of psychology using telepsychology, a psychologist or psychology associate shall evaluate the client to determine that delivery of telepsychology is appropriate considering at least the following factors: (1) The client’s: (a) Diagnosis; (b) Symptoms; (c) Medical and psychological history; and (d) Preference for receiving services via telepsychology; and (2) The nature of the services to be provided, including anticipated: (a) Benefits; (b) Risks; and (c) Constraints resulting from their delivery via telepsychology. B. The client evaluation set forth in §A of this regulation shall take place at an initial in-person session, unless the psychologist or psychology associate documents in the record the reason for not meeting in person. #### Regulation .06 Discipline. *COMAR 10.36.10.06* A. The Board shall use the same standards in evaluating and investigating a complaint and disciplining a psychologist or psychology associate who practices telepsychology as it would use for a psychologist or psychology associate who does not use telepsychology technology in the licensee’s practice. B. The failure of a psychologist or psychology associate to comply with this chapter shall constitute unprofessional conduct and may be subject to disciplinary action by the Board. ## Subtitle 37 — Health Services Cost Review Commission ### Chapter 01 — Uniform Accounting and Reporting System for Hospitals and Related Institutions **Authority:** Health-General Article, §§19-207, 19-215, and 19-303,Annotated Code of Maryland **Administrative History:** Effective date: April 24, 1973 **Administrative History:** Regulation .01B, C, E, F, J, and K adopted effective September 19, 1974 (1:1 Md. R. 17) **Administrative History:** Regulation .03 amended effective July 28, 1978 (5:15 Md. R. 1189) **Administrative History:** Regulation .03A, C amended effective May 4, 1979 (6:9 Md. R. 728) **Administrative History:** Regulation .03D amended effective October 29, 1975 (2:24 Md. R. 1481); May 11, 1977 (4:10 Md. R. 767) **Administrative History:** Regulation .03D, E amended effective April 7, 1978 (5:7 Md. R. 522) **Administrative History:** Regulation .03H amended effective August 18, 1976 (3:17 Md. R. 915); August 31, 1977 (4:18 Md. R. 1398); July 28, 1978 (5:15 Md. R. 1189); December 29, 1978 (5:26 Md. R. 1922); May 4, 1979 (6:9 Md. R. 728) **Administrative History:** Regulation .03I adopted effective August 18, 1976 (3:17 Md. R. 915) **Administrative History:** Regulation .03J adopted effective July 28, 1978 (5:15 Md. R. 1189); December 29, 1978 (5:26 Md. R. 1922); May 4, 1979 (6:9 Md. R. 728) **Administrative History:** Regulations .04 and .05 effective April 29, 1973 **Administrative History:** Regulation .05G amended as an emergency provision effective December 23, 1976 (4:2 Md. R. 73) **Administrative History:** Regulation .06 adopted effective September 19, 1974 (1:1 Md. R. 17) **Administrative History:** Regulation .07 adopted effective April 7, 1978 (5:7 Md. R. 522) **Administrative History:** Regulations .01—.03 amended effective October 3, 1980 (7:20 Md. R. 1879) **Administrative History:** Regulation .01A amended effective December 14, 1987 (14:25 Md. R. 2660) **Administrative History:** Regulation .02 amended effective December 14, 1987 (14:25 Md. R. 2660); May 29, 1989 (16:10 Md. R. 1109); April 5, 1999 (26:7 Md. R. 543) **Administrative History:** Regulation .02A amended effective January 8, 1990 (16:26 Md. R. 2793); February 4, 1991 (18:2 Md. R. 149); January 6, 1992 (18:26 Md. R. 2830); August 30, 1993 (20:17 Md. R. 1346); January 2, 1995 (21:26 Md. R. 2188); May 6, 1996 (23:7 Md. R. 553); April 7, 1997 (24:7 Md. R. 553); May 4, 1998 (25:9 Md. R. 680); April 5, 1999 (26:7 Md. R. 543); March 6, 2000 (27:4 Md. R. 454); July 9, 2001 (28:13 Md. R. 1216); September 30, 2002 (29:19 Md. R. 1524); March 29, 2004 (31:6 Md. R. 509); August 1, 2005 (32:15 Md. R. 1321); April 10, 2006 (33:7 Md. R. 673); June 4, 2007 (34:11 Md. R. 971); May 18, 2009 (36:10 Md. R. 717); April 5, 2010 (37:7 Md. R. 571); June 27, 2011 (38:13 Md. R. 756); July 9, 2012 (39:13 Md. R. 785); April 14, 2014 (41:7 Md. R. 422); December 21, 2015 (42:25 Md. R. 1543); August 13, 2018 (45:16 Md. R. 775); March 9, 2020 (47:5 Md. R. 311); February 8, 2021 (48:3 Md. R. 94); December 11, 2023 (50:24 Md. R. 1042); November 25, 2024 (51:23 Md. R. 1036); April 14, 2025 (52:7 Md. R. 323) **Administrative History:** Regulation .03 amended effective July 1, 1985 (12:13 Md. R. 1279); December 10, 2001 (28:24 Md. R. 2128); October 5, 2009 (36:20 Md. R. 1529) **Administrative History:** Regulation .03 amended as an emergency provision effective January 1, 2014 (41:2 Md. R. 89); amended permanently effective April 14, 2014 (41:7 Md. R. 422) **Administrative History:** Regulation .03 amended effective August 4, 2014 (41:15 Md. R. 890) **Administrative History:** Regulation .03D, E amended effective November 30, 2009 (36:24 Md. R. 1858) **Administrative History:** Regulation .03F repealed effective January 1, 1983 (9:16 Md. R. 1605) **Administrative History:** Regulation .03H amended effective January 1, 1984 (10:15 Md. R. 1351); October 10, 1994 (21:20 Md. R. 1732); February 12, 2007 (34:3 Md. R. 299) **Administrative History:** Regulation .03H, L amended effective August 3, 1981 (8:15 Md. R. 1308); November 19, 1984 (11:23 Md. R. 1992); July 1, 1985 (12:13 Md. R. 1279); March 10, 1986 (13:5 Md. R. 545) **Administrative History:** Regulation .03H, L amended as an emergency provision effective May 25, 1986 (13:12 Md. R. 1372); emergency status expired September 16, 1986 **Administrative History:** Regulation .03H, L amended effective November 3, 1986 (13:22 Md. R. 2399); December 15, 1986 (13:25 Md. R. 2660); December 28, 1987 (14:26 Md. R. 2747); September 4, 1989 (16:17 Md. R. 1886); April 27, 1992 (19:8 Md. R. 805) **Administrative History:** Regulation .03I repealed effective February 13, 2006 (33:3 Md. R. 241) **Administrative History:** Regulation .03K amended as an emergency provision effective April 1, 2003 (30:8 Md. R. 538); amended permanently effective July 7, 2003 (30:13 Md. R. 854) **Administrative History:** Regulation .03K amended effective June 6, 2005 (32:11 Md. R. 983) **Administrative History:** Regulation .03L amended effective February 13, 2006 (33:3 Md. R. 241) **Administrative History:** Regulation .03L-1, L-2 adopted effective March 8, 1999 (26:5 Md. R. 391) **Administrative History:** Regulation .03L-1 amended effective November 15, 2010 (37:23 Md. R. 1610) **Administrative History:** Regulation .03L-3 adopted effective June 9, 2003 (30:11 Md. R. 735) **Administrative History:** Regulation .03L-5 adopted effective January 13, 2011 (38:1 Md. R. 11) **Administrative History:** Regulation .03M amended effective November 11, 2024 (51:22 Md. R. 963) **Administrative History:** Regulation .03N amended as an emergency provision effective September 2, 1991 (18:19 Md. R. 2095); emergency status expired February 3, 1992 **Administrative History:** Regulation .03N amended effective January 6, 1992 (18:26 Md. R. 2830); March 8, 1999 (26:5 Md. R. 391); March 4, 2013 (40:4 Md. R. 346) **Administrative History:** Regulation .06D amended effective March 4, 2013 (40:4 Md. R. 346) **Administrative History:** Regulation .06I adopted effective June 30, 1986 (13:13 Md. R. 1492) **Administrative History:** Regulation .06I amended effective August 13, 2007 (34:16 Md. R. 1432) **Administrative History:** Regulation .08 adopted effective January 6, 1992 (18:26 Md. R. 2830) **Administrative History:** Regulation .08A, B amended effective September 14, 2015 (42:18 Md. R. 1174) #### Regulation .01 Definitions. *COMAR 10.37.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accounting and Reporting System for Hospitals” means the system originally adopted by the Commission in 1973 and as amended which is in effect at the time the System is referred to in these regulations. The System is also referred to as “the Rate Review System”, or “the Accounting and Budget Manual for Fiscal and Operating Management”. (2) “Beneficial owner” means that person who ultimately benefits or suffers losses from the operation of the firm or has a vested interest in it, and includes, but is not limited to, limited partners, beneficiaries of voting or other trusts, and limited term and remaindermen beneficiaries or owners. (3) “Firm” means a partnership, corporation or other business professional, or academic entity, and, in the case of sole proprietors or practitioners, the trustee himself. (4) “Notify in writing” or “written notification” means personal delivery to the person to be notified, or mailing through the United States Postal Services, by registered or certified mail, return receipt requested to the person to be notified. (5) “Officer” means: (a) An individual who is elected to office pursuant to a resolution of the governing board of the hospital or related institution, to fill a position defined in the bylaws of the hospital or related institution; or (b) An individual who, although not specifically designated as an “officer” administers the policies of the hospital or related institution, and has the authority and performs the duties in the management of the property and affairs of the hospital or related institution as may be provided in the bylaws. (6) “Partner” means any partner who has voting power or management or policy responsibilities, regardless of restrictions thereon, but excludes limited partners or other partners who have no vote in or management or policy responsibilities as to the partnership. (7) “Section 556 hospitals” or “hospitals” means all hospitals as defined in Article 43, §556, Annotated Code of Maryland. (8) “Section 556 nursing homes” or “nursing homes” or “Section 556 care homes” or “care homes” means all nursing homes or care homes as defined in Article 43, §556, Annotated Code of Maryland. (9) “Section 556 related institutions” or “related institutions” means all related institutions as defined in Article 43, §556, Annotated Code of Maryland. (10) “Trustee" or "director” means any person serving on a governing board or committee of a nonprofit hospital or related institution who is empowered to vote on matters concerning the hospital's or related institution's governance or other matters generally concerning its policies. (11) “Willfully” means acting in a purposeful and not a negligent or accidental manner, but need not encompass a criminal intent not to observe or to breach any statute or rule of law. #### Regulation .02 Accounting System; Hospitals. *COMAR 10.37.01.02* A. The Accounting System. (1) The accounting system set forth in the Commission's "Accounting and Reporting System for Hospitals” first issued in February, 1973, shall be used by all hospitals under the jurisdiction of the Commission for their fiscal year period beginning on or after April 1, 1973, and all subsequent periods. (2) The “Accounting and Reporting Systems for Hospitals”, also known as the Accounting and Budget Manual for Fiscal and Operating Management (October 1, 2024) is incorporated by reference. (3) The Commission shall provide each hospital under its jurisdiction with a copy of the most recently updated Accounting and Budget Manual for Fiscal and Operating Management, which shall represent the official interpretation of accounting and reporting practices and procedures of the System. (4) The Executive Director is authorized and empowered by the Commission to allocate specific items to specific accounts within the system when the allocations are necessary to assume uniformity of accounting procedures. Furthermore, any proposed technical changes to the Accounting and Budget Manual will be posted on the HSCRC website for public comment. Technical changes mean non-substantive, revenue neutral updates. (5) Requests for exceptions to the system may be filed as provided in §C. B. Accrual Accounting. (1) A full accrual basis of accounting for revenue and expenses is required. (2) Revenues shall be given recognition in the period during which the service is provided. (3) Revenue shall be recorded at the full established rates regardless of the amounts actually paid to the hospital or on behalf of the patients. (4) Revenue deductions shall be given accounting recognition in the same period that the related revenues are recorded. (5) Expenses shall be given recognition in the period in which there is: (a) A direct identification or association with revenue, as in the case of services rendered to patients; (b) An indirect association with revenue, as in the case of salaries or rent; or (c) A measurable expiration of asset costs even though not associated with the production of revenue for the current period as in the loss from fire. C. Requests for Exceptions to System Manual. (1) As provided by Health-General Article, §19-211(b), hospitals may file a written request for exception with the Commission. (2) The Executive Director shall respond in writing promptly to the requesting hospital on receipt of the request acknowledging its receipt and providing the requesting hospital with a date by which the request shall be answered. (3) If needed for evaluation of the request, the Executive Director will seek additional information from the appropriate source. D. Review of Denial of Request for Exception. (1) Any hospital denied an exception to the accounting system or manual may file a written petition to the Commission for a hearing to review the action of the Executive Director in refusing its request for exception. (2) A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the aggrieved hospital was notified in writing of the action taken on the requested exception, and shall state the grounds for the petition. (3) A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commissioners chosen by the Chairman for that purpose. (4) The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospitals or related institutions. (5) Promptly after the hearing, the subcommittee shall report to the Commission, which shall make its decision within 45 days of the submission of the petition to review. (6) The decision of a majority of the Commission, which shall be recorded in the form of a written decision filed with the Commission's office, shall be final, subject to the right of appeal in accordance with Health-General Article, §19-221. #### Regulation .03 Reporting Requirements; Hospitals. *COMAR 10.37.01.03* A. Annual Financial Statements. (1) The following audited financial statements are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: (a) Balance Sheet—Unrestricted Funds (AUB); (b) Balance Sheet—Restricted Funds (ARB); (c) Statement of Change in Equity (AFB); (d) Statement of Revenue and Expense (ARE); (e) Statement of Change in Financial Position (AFP). (2) The above reports shall be recorded on the basis of actual data and be submitted within 90 days after the end of each hospital's fiscal year. (3) Report AUB, ARB, AFB, ARE, and AFP as required above shall include attests by the institution's certified public accountants. B. Monthly Financial Statements. (1) The following unaudited financial statements are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: (a) Balance Sheet—Unrestricted Funds (QUB); (b) Balance Sheet—Restricted Funds (QRB); (c) Statement of Revenues and Expenses (QRE). (2) The above reports shall be recorded on the basis of actual data and be submitted within 30 days after the end of each month of the calendar year. C. Monthly Financial Statement Summary. (1) The following unaudited monthly financial statement summary is required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: Financial Statement Summary—(FS). (2) Schedule FS shall be completed on the basis of actual data in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”. (3) Schedule FS is to be submitted within 30 days after the end of each month of the calendar year in the format prescribed by the Commission. D. Monthly Reports of Achieved Volumes and Revenues. (1) The following monthly volume and revenue reports are required to be submitted by each hospital under the jurisdiction of the Commission, with the exception of those hospitals that are a part of the Maryland Department of Health: (a) Statistical Data and Revenue Summary — Daily Hospital Services; (b) Statistical Data and Revenue Summary — Ambulatory Services and Admissions Services; (c) Statistical Data and Revenue Summary — Ancillary Services. (2) The Monthly Reports of Achieved Volumes and Revenues shall be completed on the basis of actual data in the format prescribed by the Commission. (3) The Monthly Reports of Achieved Volumes and Revenues shall be submitted within 30 days after the end of each month of the calendar year in the format prescribed by the Commission. (4) The Monthly Reports of Achieved Volumes and Revenues submitted under this section shall be made in the format as published in the Maryland Register and on the Commission’s website (http://www.hscrc.maryland.gov). E. Annual Report of Revenue and Volume Comparisons. (1) The following annual report of revenue and volume comparisons is required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: Revenue and Volume Comparisons (RVC). (2) Schedule RVC shall be completed on the basis of actual data in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”. (3) Schedule RVC shall be submitted within 90 days after the end of each hospital's fiscal year in the format prescribed by the Commission. F. Annual Reports of Revenues, Expenses, and Volumes. (1) The following annual reports of revenues, expenses, and volumes are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: (a) Inpatient and Patient Days (V1A, V1B, V1C, V1D); (b) Outpatient Visits (V2A, V2B); (c) Ancillary Service Units (V3A, V3D); (d) Equivalent Inpatient Days and Admissions (V5); (e) Allocation of Data Processing (DP1); (f) Unassigned Expense (UA); (g) Hospital Based Physicians (P1A, P1B); (h) Medical Staff Services (P2A to P2I); (i) Physical Support Services (P3A to P3H); (j) Residents, Interns Services—Eligible (P4A to P4I); (k) Residents, Interns Services—Ineligible (P5A to P5I); (l) Overhead Expense Summary (OES); (m) General Service Center (C1 to C14); (n) Patient Care Center (D1 to D81); (o) Auxiliary Enterprises (E1 to E9); (p) Other Institutional Programs (F1 to F4); (q) Allocation of Cafeteria, Parking, Etc. (OAA to OAK); (r) Reconciliation of Base Year Expenses to Schedule RE (RC); (s) Statement of Revenue and Expenses (RE); (t) Overhead Expense Apportionment (J1 to J4); (u) Overhead Statistical Apportionment (J51 to J54); (v) Building Facility Allowance (H1); (w) Departmental Equipment Allowance (H2A to H2Y); (x) Distribution of Capital Facilities Allowances (H3A to H3D); (y) Capital Facility Allowance Summary (H4); (z) Cash and Marketable Assets (GR); (aa) Payor Differential (PDA); (bb) MB Revenue (M, MA, MB); (cc) Unregulated Services (UR1 to UR6); (dd) Operating Room Survey (ORS); (ee) Other Financial Considerations (G); (ff) Annual Cost Survey (ACS); (gg) Transactions with Related Entities (TRE); (hh) Revenue and Volume Comparisons (RVC); (ii) Schedule D Personnel Schedules (PH1 to PH2); (jj) Utilization of Therapies (TU). (kk) Mandated Trauma Cost (MTC); and (ll) Stand-By Costs (SBC). (2) The above annual reports of revenues, expenses, and volumes shall be completed on the basis of actual data and certain projected data in the form prescribed by the Commission in the “Accounting and Reporting System for Hospitals”. (3) The above annual reports of revenues, expenses, and volumes shall be submitted within 90 days after the end of each hospital's fiscal year in the format prescribed by the Commission. (4) Collection and Submission of Data. Upon the effective date of this regulation, each hospital under the jurisdiction of the Health Services Cost Review Commission shall submit the following data elements relative to bad debts and uncompensated care in accordance with the instructions detailed in the Accounting and Budget Manual: (a) Inpatient uncompensated care and bad debts; (b) Outpatient uncompensated care and bad debts. G. Repealed. H. Special Audit. (1) An audit of various data submitted in the Annual Reports of Revenues, Expenses, and Volumes, Wage and Salary Survey, and the Annual Report of Change in Building and Equipment Fund Balances is required to be performed by the independent certified public accounting firm of each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health. (2) The audit procedures shall be completed in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”. (3) The results of the audit shall be submitted to the Commission within 110 days after the end of each hospital's fiscal year in the format prescribed by the Commission. I. Annual Reports of Wage and Salary Survey. (1) The following annual reports of wage and salary survey are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: (a) Wage, Salary and Fringe Benefits Summary (WSA, WSB, WSC); (b) Fringe Benefits Calculation (FB). (2) Schedules WSA, WSB, WSC, and FB shall be completed on the basis of actual data in the form prescribed by the Commission contained in the “Accounting and Reporting System for Hospitals”. (3) Schedules WSA, WSB, WSC, and FB shall be submitted by June 1 of every calendar year in the format prescribed by the Commission. (4) The Commission may require the submission of nonpersonally identifiable wage and salary data elements for individual employees. J. Rate Review Reports. (1) The following rate review reporting schedules are required to be submitted by each Section 556 hospital, with the exception of those hospitals that are a part of the Maryland Department of Health: (a) Inpatient and Patient Days (V1A, V1B, V1C, V1D); (b) Outpatient Visits (V2A, V2B); (c) Ancillary Service Units (V3A, V3D); (d) Equivalent Inpatient Days and Admissions (V5); (e) Allocation of Data Processing (DP1); (f) Unassigned Expense (UA); (g) Hospital Based Physicians (P1A, P1B); (h) Medical Staff Services (P2A to P2I); (i) Physician Support Services (P3A to P3H); (j) Residents, Interns Services—Eligible (P4A to P4I); (k) Residents, Interns Services—Ineligible (P5A to P5I); (l) Overhead Expense Summary (OES); (m) General Service Center (C1 to C14); (n) Patient Care Center (D1 to D81); (o) Auxiliary Enterprises (E1 to E9); (p) Other Institutional Programs (F1 to F4); (q) Allocation of Cafeteria, Parking, etc. (OAA to OAK); (r) Reconciliation of Base Year Expenses to Schedule RE (RC); (s) Statement of Revenue and Expenses (RE); (t) Overhead Expense Apportionment (J1 to J4); (u) Overhead Statistical Apportionment (J51 to J54); (v) Building Facility Allowance (H1); (w) Departmental Equipment Allowance (H2A to H2Y); (x) Distribution of Capital Facilities Allowances (H3A to H3D); (y) Capital Facility Allowance Summary (H4); (z) Cash and Marketable Assets (GR); (aa) Payor Differential (PDA); (bb) MB Revenue Centers (M, MA, MB); (cc) Unregulated Services (UR1 to UR6); (dd) Operating Room Survey (ORS); (ee) Other Financial Considerations (G); (ff) Annual Cost Survey (ACS); (gg) Transactions with Related Entities (TRE); (hh) Revenue and Volume Comparisons (RVC); (ii) Schedules D Personnel Schedules (PH1 to PH2); (jj) Utilization of Therapies (TU); (kk) (MTC) Mandated Trauma Cost; and (ll) (SBC) Stand-by Costs. (2) The above review reports shall be completed on the basis of actual data and certain projected data in the form prescribed by the Commission in the “Accounting and Reporting System for Hospitals”. K. Interns and Residents Survey. (1) Hospitals shall submit the Interns and Residents Survey to the Commission by January 15 of every calendar year. (2) Hospitals shall complete the survey on the basis of actual data in the form prescribed by the Commission. L. General Assembly Studies and Other Reports. The Commission may require hospitals to submit information in response to information required of the Commission by the Maryland General Assembly. M. Annual Nonprofit Hospital Community Benefit Report. (1) Beginning on December 15, 2009, each nonprofit hospital shall submit the Annual Nonprofit Hospital Community Benefit Report to the Commission by the date prescribed by the Commission in the format prescribed by the Commission. (2) Hospitals shall complete the report on the basis of actual data covering the reporting period of the previous July 1 through June 30 or other time period as specified by the Commission. (3) The Commission shall provide instructions for completing the report on its public website. N. Internal Revenue Service Form 990. Beginning on October 1, 2009, each nonprofit hospital shall submit its most recent Form 990 that the facility filed with the Internal Revenue Service within 30 days from the Internal Revenue Service filing. O. Annual Debt Collection Report. (1) Hospitals shall submit the Annual Debt Collection Report to the Commission within 60 days after the end of each hospital’s fiscal year. (2) Hospitals shall complete the report on the basis of actual data in the form prescribed by the Commission. (3) The Commission shall provide instructions for completing the report in its Accounting and Budget Manual for Fiscal and Operating Management. P. All-Payer Model Agreement Data Requirements. Hospitals shall submit data in accordance with the requirements of the January 1, 2014 All-Payer Model Agreement executed between the State of Maryland and the Center for Medicare and Medicaid Innovation for evaluation purposes. Q. Report Format Changes. The Commission, after consideration at a public meeting or other public forum, may modify the reporting requirements of the above reports as it deems necessary, if reasonable notice is given to each hospital under its jurisdiction and all designated interested parties using the “Accounting and Reporting System for Hospitals”. R. Failure to File Reports. (1) A hospital under the jurisdiction of the Commission which does not file any report under the Enabling Act of the Commission, Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland, or under the regulations of the Commission, is liable for a civil penalty of up to $1,000 per day for each day the filing of the report is delayed unless an extension is granted as provided in §O of this regulation. (2) These fines may not be considered reasonable costs for purposes of rate setting by the Commission. (3) The Commission may refuse to grant a rate increase to any hospital which does not file a report required under its enabling legislation (Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland) or its regulations. (4) Any required report submitted to the Commission which is substantially incomplete or inaccurate may not be considered timely filed. In addition, any incomplete or inaccurate report submitted by a hospital that results in, or will result in, rates which, through the application of normal Commission methodology, vary, or will vary, from the allowed corridors specified in COMAR 10.37.03.05F, may not be considered timely filed. (5) All annual reports required to be filed with the Commission shall contain an attestation by the institution's chief financial officer that, to the best of the officer's information and belief, the reports filed have been prepared in conformity with the Commission's uniform accounting and financial reporting system as set forth in the Manual. (6) All annual reports required to be filed with the Commission shall contain an attestation by the institution's chief executive officer that, to the best of the officer's information and belief, neither the hospital, its related entity, nor any entity or person acting on behalf of or in concert with the hospital knowingly is participating in or receiving the benefit of any fixed price arrangement, directly or indirectly, pertaining to the delivery of hospital services without approval by the Commission. S. Requests for Extension of Time to File Required Reports. (1) A Section 556 hospital under the jurisdiction of the Commission may file with the Commission written requests for reasonable extensions of time to file any or all of the required reports. (2) The requests for extensions will be supported by justification for the approval of the extension request. (3) The Executive Director shall respond promptly in writing to the requesting hospital upon receipt of the request by either approving or disapproving the request. (4) If it is needed for evaluation of the request, the Executive Director will seek information from the requesting hospital. (5) Requests for extensions shall be made at a reasonable time before the due date of a required report. Extensions will be granted only for valid reasons. (6) In the case of a submission of the Annual Reports of Revenues, Expenses, and Volumes, requests for extensions shall generally be made at least 45 days before the due date. Failure of a hospital to have its audited financial statements completed may generally not constitute a valid reason for an extension. T. Review of Denial of Request for Extension. (1) A hospital denied an extension of time under §O may file a written petition with the Commission for a hearing to review the action of the Executive Director in refusing its request for extension. (2) A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the aggrieved hospital was notified in writing of the action with respect to the requested extension and shall state the grounds for the petition. (3) A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commission chosen by the Chairman for that purpose. (4) The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospitals or related institutions. (5) Promptly after the hearing, the subcommittee shall report to the Commission which shall make its decision within 45 days of the submission of the petition to review. (6) The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall be final, subject to the right of review in accordance with Health-General Article, §19-221. U. Stay of Charges. (1) Unless the Commission reverses the Executive Director, the filing of a written petition pursuant to §P may not stay the continued accrual of the charges levied under §N against a hospital which fails to meet the deadline for filing reports required in these regulations. (2) If the Commission affirms the decision of the Executive Director, the penalties which accrued during the appeal period may be suspended or reduced by the Commission. #### Regulation .04 Accounting System: Related Institutions. *COMAR 10.37.01.04* A. The Accounting System. (1) The accounting system set forth in the Commission's “Accounting and Reporting System for Related Institutions” issued in March, 1973, shall be used by all Section 556 related institutions for their fiscal year period beginning on, or after, April 1, 1973, and all subsequent periods. (2) The “Accounting and Reporting System for Related Institutions” is incorporated in these regulations as if set forth in full. (3) The Commission shall provide each section 556 related institution with a copy of “Accounting and Reporting System for Related Institutions” which may be amended pursuant to the Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland. (4) The Executive Director is authorized and empowered by the Commission to allocate specific items to specific accounts within the System when the allocations are necessary to assure uniformity of accounting procedures. (5) Requests for exceptions to the System may be filed as provided in §D, of this regulation. B. Accrual Accounting. (1) A full accrual basis of accounting for revenue and expenses is required. (2) Revenues shall be given recognition in the period during which the service is provided. (3) Revenues shall be recorded at the full established rates regardless of the amounts actually paid to the related institution by, or on behalf of, the patients. (4) Revenue deductions shall be given accounting recognition in the same period that the related revenues are recorded. (5) Expenses shall be given recognition in the period in which there is: (a) A direct identification or association with revenue, as in the case of services rendered to patients; (b) An indirect association with revenue, as in the case of salaries or rent; or (c) A measurable expiration of asset costs even though not associated with the production of revenue for the current period, as in the case of losses from fire. C. Manual. (1) As may be necessary to assure uniformity of accounting and reporting procedures, the Commission may adopt a manual which will be supplemental to the system hereby adopted, to be incorporated in these regulations in the same manner as set forth in §A(2), of this regulation. (2) The Commission shall provide each section 556 related institution with a copy of the manual, which may be amended pursuant to the Administrative Procedure Act, State Government Article, Title 10, Annotated Code of Maryland. (3) Any manual adopted by the Commission shall be the official interpretation of accounting and reporting practices and procedures within the Related Institution Accounting and Reporting System. (4) Requests for exceptions to the manual may be filed as provided in §D, of this regulation. D. Requests for Exceptions to System or Manual. (1) As provided by Health-General Article, §19-211(b), Annotated Code of Maryland, related institutions may file a written request for exception with the Commission. (2) The Executive Director shall respond in writing promptly to the requesting related institution on receipt of the request, acknowledging its receipt and providing the requesting related institution with a date by which the request shall be answered. (3) If needed for evaluation of the request, the Executive Director will seek additional information from the appropriate source. E. Review of Denial of Request for Exception. (1) Any related institution denied an exception to the accounting system or manual may file a written petition to the Commission for a hearing to review the action of the Executive Director in refusing its request for exception. (2) A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the related institution aggrieved was notified in writing of the action taken on the requested exception and shall state the grounds for the petition. (3) A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commission chosen by the Chairman for that purpose. (4) The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospitals or related institutions. (5) Promptly after the hearing, the subcommittee shall report to the Commission which shall make its decision within 45 days of the submission of the petition to review. (6) The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall be final, subject to the right of appeal in accordance with Health-General Article, §19-221, Annotated Code of Maryland. #### Regulation .05 Reporting Requirements, Related Institutions. *COMAR 10.37.01.05* A. Required Annual Reports and Statements. Each section 556 related institution shall submit annually to the Commission, within 90 days after the close of the related institution's annual accounting period (fiscal year), the following reports and statements as specified in Section III of Accounting and Reporting System for Related Institutions: (1) A balance sheet (Schedule D); (2) A statistical, cost finding and revenue analysis report (Schedules A, B, and G); (3) A profit and loss statement (Schedule C); (4) Statements of selected data related to owners and related organizations (Schedules E and F); (5) Certification (Schedule H); (6) A statement of its dealings and relationships with certain entities. B. Report Formats. (1) The required report and statement formats to be used by section 556 related institutions when submitting the annual reports and statements required by §A, of this regulation, are those presented in the Commission's “Accounting and Reporting System for Related Institutions,” except for the statement required under §A(6), of this regulation. (2) Nonprofit related institutions shall file a verified statement pursuant to §A(6), of this regulation, setting forth the following information in substantially the following form: (3) Proprietary related institutions shall file a verified statement pursuant to §A(6) setting forth the following information in substantially the following form: C. Failure to File Reports. (1) Any section 556 related institution which does not file any report or statement required herein is liable for a civil penalty of $100 per day for each day the filing of the report or statement is delayed unless an extension is granted as provided in §D of this regulation. (2) This penalty may not be considered a part of reasonable costs for purposes of rate setting by the Commission. D. Requests for Extension of Time to File Required Reports or Statements. (1) Any section 556 related institution may file with the Commission written requests for reasonable extensions of time to file any or all of the required reports or statements. (2) The requests for extensions shall be supported by justification for the approval of the extension requests. (3) The Executive Director shall respond promptly in writing to the requesting related institution upon receipt of the requests by either approving or disapproving the requests. (4) If needed for evaluation of any request, the Executive Director will seek additional information from the requesting related institution. E. Review of Denial of Request for Extension. (1) Any related institution denied an extension of time under §D may file a written petition with the Commission for a hearing to review the action of the Executive Director in refusing its request for extension. (2) A petition for a hearing to review the Executive Director's action shall be filed with the Commission within 15 days of the date on which the related institution aggrieved was notified in writing of the action with respect to the requested extension and shall state the grounds for the petition. (3) A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 30 days of the date on which the petition was filed, before a review subcommittee composed of three members of the Commission chosen by the Chairman for this purpose. (4) The review subcommittee shall consist of at least two persons who have no connection with the management or policy of any hospital or related institution. (5) Promptly after the hearing, the subcommittee shall report to the Commission, which shall make its decision within 45 days after the date of the submission of the petition to review. (6) The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall be final, subject to the right of review in accordance with Health-General Article, §19-221, Annotated Code of Maryland. F. Stay of Charges. (1) Unless the Commission reverses the action of the Executive Director, the filing of a petition pursuant to §E may stay the continued accrual of the charges levied under §C against a related institution which fails to meet the deadline for filing reports or statements required in these regulations. (2) In cases where the Commission affirms the action of the Executive Director, the penalties which accrued during the appeal may be suspended or reduced by the Commission. #### Regulation .06 Non-Profit Hospitals and Related Institutions: Disclosure of Interest by Trustees. *COMAR 10.37.01.06* A. The Guide and Instructions. The Guide for the Trustee's Disclosure of Interest Statement and the instructions for it set forth immediately following these regulations concerning disclosure, are hereby incorporated in these regulations. B. Periods Covered by the Statement. The statement shall report all business transactions described in Health-General Article, §19-220, Annotated Code of Maryland, during the hospital's or related institution's fiscal year beginning on, or after, July 1, 1973 and an additional statement shall report business transactions during each succeeding fiscal year of the hospital or related institutions or fraction of that year that the trustee serves the hospital or related institution. C. Filing of Statements. The trustee shall file the completed, executed, and verified statement with the Commission within 90 days after the end of the fiscal year to which it applies. D. Failure or Delay in Filing Statements. (1) Any trustee who does not file the statement on the date it is due is liable for a civil penalty or fine of $250 per day for each day the filing of the statement is delayed, unless an extension is granted and a stay of filing is granted as provided in §§E, F, and G of this regulation. (2) This penalty or fine may not be considered reasonable costs for purposes of rate setting by the Commission if the hospital or related institution reimburses or indemnifies the trustee therefor in any manner. E. Request for Extension of Time to File Statements. (1) A trustee may file with the Commission a written request for a reasonable extension of time to file his statement. (2) The request for extension shall be supported by justification for the approval of the extension request. (3) The Executive Director shall respond promptly in writing to the requesting trustee upon receipt of the request by either approving or disapproving the request. (4) If needed for evaluation of the request, the Executive Director may seek additional information from the requesting trustee, his firm, the hospital or related institution on whose board he serves, or other pertinent sources. F. Review of Denial of Request for Extension. (1) Any trustee denied or given an inadequate extension of time under §E, of this regulation, may file a written petition with the Commission to review the action of the Executive Director in refusing his request for extension or giving him an inadequate extension, within 10 days of the date on which the trustee was notified in writing of the action with respect to the requested extension. The petition shall state the grounds for the proposed extension and request a review of the denial of his request for it. (2) A hearing on the petition, at which the petitioner may be represented by counsel, shall be held within 20 days of the date on which the petition was filed, before a disclosure subcommittee composed of one or more members of the Commission chosen by the Chairman for that purpose. (3) The disclosure subcommittee shall consist of a majority of persons who have no connection with the management of policy of any hospital or related institution. (4) Promptly after the hearing, the disclosure subcommittee shall report to the Commission which shall render its decision within 30 days of the submission of the petition to review. (5) The decision of a majority of the Commission, which shall be rendered in the form of a written decision filed in the Commission's office, shall assess a specific penalty not exceeding the amount of penalty set forth in §D, of this regulation, or state that no penalty is imposed, as set forth in these regulations, and shall be final, subject to the right of review in accordance with Health-General Article, §19-221, Annotated Code of Maryland. G. Accrual of Penalty. The filing of a petition pursuant to §F, of this regulation, may not stay the accrual of the penalty imposed pursuant to §D, of this regulation. However, the penalty may not be assessed against or collected from the trustee until the conclusion of the proceeding initiated by the trustee's petition. The penalty may be modified in accordance with the Commission's decision, and the Commission may abate or reduce the penalty as justice and equity may require. H. Review, Question, and Substantiation of the Statement. (1) During the 6 months immediately following the filing of each statement, the Commission, after a review of it, may question the statement and require substantiation of facts and matters set forth in it. (2) During the 3 years immediately following the filing of each statement, the Commission, after a review of it, may question the statement as to any relevant fact or matter not set forth in it and require explanations and other disclosures regarding these facts and matters. (3) During the 4 years immediately following the end of each fiscal year of a hospital or related institution, the Commission may question the business transactions between the hospital or related institution and any firm connected as set forth in these regulations with any of the hospital's or related institution's trustees who did not file a statement pertaining to that year. (4) Upon any question by the Commission as set forth in this regulation, the Commission's staff may investigate the questioned situation and hold informal conferences with the trustee in question, or other persons having knowledge of the situation, and hearings may be held on it by the Commission or a subcommittee of the Commission. (5) At informal conferences of the questioned trustee or other persons with the Commission staff, the attendance of persons and the production of specific records, documents, contracts, data, checks, ledgers, or other papers of the trustee, his firm, or the hospital or related institution may be requested, and the Executive Director or his designee may administer oaths or affirmations in the course of statements by any person and in the course of proffers of documents or other papers by the trustee or any person. (6) At hearings held as a result of any questions regarding a trustee's disclosure or lack of disclosure, as set forth in this regulation, the Commission may subpoena witnesses, papers, records, and documents relating to it in the possession of any person, entity, or hospital or related institution. (7) At any time before or during an informal conference held under these regulations, the questioned trustee, if he is scheduled to appear or is present at the conference, or the senior member of the Commission's staff participating in the conference, may request a hearing thereon before the Commission or a subcommittee of the Commission, and this informal conference shall be cancelled or terminated, as the case may be, and a hearing promptly scheduled. (8) Statements, facts, or matters fully set forth in it may not be questioned after 6 months after its filing, and unless the particular trustee is notified in writing of the question by the Commission during the 6-month period, all investigations of it shall cease. However, all questions, investigations, and other actions begun during the 6 month period or which are the subject of notice to the trustee as set forth in this regulation, shall be continued to a proper conclusion. I. Information Required of Non-Profit Facilities. (1) A nonprofit facility subject to the jurisdiction of the Commission shall file with the Commission within 90 days from the close of its fiscal year a list of all trustees, directors, or officers of the facility. (2) The list shall include the following: (a) The name and business address of the trustee, director, or officer; and (b) For each person so named, the nonprofit facility shall indicate whether the trustee, director, or officer is also an employee, partner, director, or beneficial owner of 3 percent or more of the capital account or stock of a partnership, firm, corporation, or any other business entity. (3) The information referred to in §I(2)(b), of this regulation, shall only be required if the business entity engaged in a transaction of $10,000 or more with the nonprofit facility during the previous fiscal year. #### Regulation .07 Further Investigation by Commission. *COMAR 10.37.01.07* In order for the Commission to be able to assure the public that the costs of a hospital are reasonable and that the reports submitted by a hospital are accurate, the Commission may, at any time, conduct an investigation of a hospital's relevant records and accounts. #### Regulation .08 Notification of Certain Financial Transactions. *COMAR 10.37.01.08* A. General. A facility subject to the jurisdiction of the Commission shall notify the Commission, in writing, within 30 days before executing any financial transaction, contract, or other agreement that would: (1) Pledge more than 50 percent of the operating assets of the facility as collateral for a loan or other obligation; (2) Result in more than 50 percent of the operating assets of the facility being sold, leased, or transferred to another person or entity; or (3) Result in more than 50 percent of all corporate voting rights or governance reserve powers being transferred to or assumed by another person or entity. B. Information Required. A facility shall file with the Commission within 30 days before executing a proposed financial transaction, contract, or other agreement as required in §A of this regulation, the following information: (1) The name and address of the person or entity to whom: (a) The operating assets of the facility are being sold, leased, transferred, or pledged as collateral for a loan or other obligation; or (b) The corporate voting rights or governance reserve powers are being transferred or assumed. (2) The precise nature of the financial transaction, contract, or other agreement. C. Failure or Delay in Reporting Certain Financial Transactions. (1) A facility under the jurisdiction of the Commission which does not notify the Commission of a proposed financial transaction, contract, or other agreement as required in §A of this regulation, is subject to all penalties prescribed by Commission law and regulation on failure to comply with reporting requirements. (2) A required statement submitted to the Commission that is substantially incomplete or inaccurate is not considered timely filed. D. Publication of Notice by Commission. The Commission shall publish a notice of the proposed financial transaction, contract, or other agreement reported by a facility, in accordance with §A of this regulation, in a newspaper of general circulation in the area where the facility is located. E. Exception. The provisions of this regulation do not apply to any financial transaction, contract, or other agreement made by a facility with any issuer of tax-exempt bonds, including the Maryland Health and Higher Education Facilities Authority, the State, or any county or municipal corporation of the State, if a notice of the proposed issuance of revenue bonds that meets the requirements of §147(F) of the Internal Revenue Code has been published. ### Chapter 02 — Standards of Rate Review **Authority:** Health-General Article, §19-216, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulation .02 adopted effective May 15, 1986 (13:9 Md. R. 1030) #### Regulation .01 Vacant. *COMAR 10.37.02.01* #### Regulation .02 Review Standards for Rate Applications by Merged and Consolidated Hospitals. *COMAR 10.37.02.02* A. The following terms have the meanings indicated. B. Terms Defined. (1) “Consolidation” means the extinguishment of two or more hospitals and by the same process a new hospital organization is formed, taking over the assets and assuming the liabilities of those passing out of existence. (2) “Mergers” means the union of two or more hospitals by the transfer of all the property of one or more of them to one of them, which continues in existence, the others being merged therein. Only the hospital that continues in existence will receive Commission approved rates for acute hospital services. C. Specific Standard. (1) In the event of a merger or consolidation as a result of which one or more of the participating hospitals no longer provides inpatient care at its existing location, the Commission shall approve rates for the surviving hospital or hospitals such that the revenues of the surviving hospital or hospitals are increased based upon one of two variable cost calculations, with the merged or consolidated facility choosing between the options. (2) The first alternative is for the surviving hospital or hospitals to receive in relation to the new admission variable costs in the first year equal to 80 percent. This figure shall be reduced to 70 percent in the second year for those new admissions. For the third year and after that, the variable cost amount built into the hospital's base for these admissions shall be 60 percent. These variable cost percentages shall be limited to the number of admissions at the closed hospital. These amounts shall be applied to the average cost of hospitals in the screening group of the closed hospital (adjusted for wage differences as appropriate). (3) The second alternative is for the surviving hospital to receive the normal 50 percent variable cost factor plus direct adjustments reflecting: (a) The cost of debt transferred from the closed facility; (b) A reasonable allowance for employees who are displaced by the merger or consolidation; (c) A reasonable allowance for the retraining of employees; (d) A reasonable allowance that permits the surviving institution to generate capital to convert a closed facility to an alternate health care use in conformance with the State Health Plan, which is incorporated by reference under COMAR 10.24.07; and (e) A reasonable retention of a portion of the savings over a 3-year period. (4) A merged or consolidated hospital may request rates from the Commission at any time consistent with Commission law and regulation. A review of the hospital's request shall be undertaken in accordance with the review and approval procedures developed by the Commission in carrying out its responsibilities under Health-General Article, §19-217. Those procedures shall establish reasonable rates based upon the premise that hospitals are to provide effective and efficient service. ### Chapter 03 — Types and Classes of Charges Which Cannot Be Changed Without Prior Commission Approval **Authority:** Health-General Article, §§9-207, 19-210, 19-212, 19-215, 19-217, 19-219, and 19-220, Annotated Code of Maryland **Administrative History:** Effective date: June 14, 1975 (2:15 Md. R. 1066; 2:20 Md. R. 1298) **Administrative History:** Chapter revised effective August 18, 1976 (3:17 Md. R. 915) **Administrative History:** Regulation .02 amended effective October 6, 2008 (35:20 Md. R. 1775) **Administrative History:** Regulation .05 adopted effective July 28, 1978 (5:15 Md. R. 1189) **Administrative History:** Regulation .05 amended effective August 31, 1992 (19:17 Md. R. 1607) **Administrative History:** Regulation .05F amended effective April 15, 1991 (18:7 Md. R. 773) **Administrative History:** Regulation .05G amended effective January 2, 1993 (19:26 Md. R. 2288) **Administrative History:** Regulations .06 and .07 adopted effective August 3, 1981 (8:15 Md. R. 1308) **Administrative History:** Regulation .06A, B amended effective November 19, 1984 (11:23 Md. R. 1992) **Administrative History:** Regulation .08 adopted effective April 12, 1982 (9:7 Md. R. 711) **Administrative History:** Regulation .08 amended effective October 10, 1983 (10:20 Md. R. 1788) **Administrative History:** Regulation .09 adopted as an emergency provision effective April 1, 1984 (11:8 Md. R. 712); emergency status expired July 1, 1984; adopted permanently effective November 19, 1984 (11:23 Md. R. 1992) **Administrative History:** Regulation .09 amended effective February 9, 1987 (14:3 Md. R. 274) **Administrative History:** Regulation .09A amended effective July 9, 1990 (17:13 Md. R. 1611); December 8, 2005 (32:24 Md. R. 1905) **Administrative History:** Regulation .09B amended effective January 8, 1990 (16:26 Md. R. 2794); July 10, 2000 (27:13 Md. R. 1211); December 8, 2005 (32:24 Md. R. 1905) **Administrative History:** Regulation .10 adopted effective September 3, 1990 (17:17 Md. R. 2080) **Administrative History:** Regulation .10 amended effective August 5, 1991 (18:15 Md. R. 1727) **Administrative History:** Regulation .10A amended effective October 6, 1997 (24:20 Md. R. 1404) #### Regulation .01 Changes in Rates. *COMAR 10.37.03.01* A hospital may not increase any existing rate or charge of any class or type or impose any new rate or charge of any class or type without the approval of the Commission, except for those changes specifically excepted by regulation or order of the Commission. #### Regulation .02 Changes in Unit Rates. *COMAR 10.37.03.02* A. A hospital may vary its unit rates within any 100 percent inpatient patient care center without prior Commission approval, if the variation does not change the average charge per unit of service as prescribed in the Commission's Rate Review System. B. A hospital may not vary its unit rates within any ancillary or ambulatory center without prior Commission approval if the Commission's Rate Review System prescribes a unit of service for that center. #### Regulation .03 Rates for Auxiliary Enterprises in Other Institutional Program. *COMAR 10.37.03.03* Any hospital may change without prior approval of the Commission its unit rate or rates in any auxiliary enterprise or other institutional program as these centers are defined in the Commission's Uniform Accounting and Reporting System and the Commission's Rate Review System. #### Regulation .04 Rates for New Services. *COMAR 10.37.03.04* Any hospital may institute a rate for a new patient care service if the rate is less than $100 and does not change the average charge per unit of service for the patient care area in which the new patient care service is being provided. #### Regulation .05 Overcharges and Undercharges by Hospitals. *COMAR 10.37.03.05* A. For purposes of this regulation, the following definitions apply: (1) “Overcharge” means any charge for a hospital service under the jurisdiction of the Commission that is in excess of its approved rate. (2) “Undercharge” means any charge for a hospital service under the jurisdiction of the Commission that is less than its approved rate. B. When any hospital overcharges by more than the allowed corridors, as defined in §G of this regulation, that overcharge shall be recovered in prospective rates at 140 percent plus appropriate interest factors. C. When any hospital overcharges less than the allowed corridor, as defined in §G of this regulation, that overcharge shall be reduced from prospectively approved rates at the actual amount of overcharge plus appropriate interest. D. When any hospital undercharges more than 2 percent in obstetrics, nursery, labor and delivery, clinic, emergency room, pediatrics, or intensive care units, that undercharge may not be recovered in prospective periods. E. When any hospital undercharges less than 2 percent in the patient service centers listed in §D of this regulation, that undercharge shall be added to prospectively approved rates at the actual amount of undercharges. F. When a hospital undercharges beyond the allowed corridors, as defined in this section, the amount of undercharge in excess of the corridors less 40 percent shall be added to prospectively approved rates. These allowed undercharge corridors are defined as follows: (1) Patient care areas, when the unit of service is (2) Admissions center ---------------------------------- 3 percent; (3) Ancillary service areas and ambulatory service G. Overcharge Corridors and Pricing for Medical/Surgical Supplies and Drugs. (1) The allowed overcharge corridors are defined as follows: (a) Daily patient care areas, ambulatory (b) Labor and delivery room -------------------------- 3 percent; (c) Renal dialysis ----------------------------------- 5 percent; (d) Ancillary service areas other than labor and (2) There are no price corridors for medical/surgical supplies and drugs. H. Notwithstanding this regulation, if any hospital's net overcharges are more than 1 percent of the hospital's total approved revenue, that overcharge shall be recovered in prospective rates at 140 percent plus appropriate interest factors. I. In cases when a flagrant disregard of approved rates is found, the Commission may require direct repayment of overcharges and penalties to those patients who were overcharged. J. The Commission may assess penalties as described in this regulation, for rates approved effective July 1, 1978. #### Regulation .06 Change in Hospital-Based Physician Compensation Source. *COMAR 10.37.03.06* A. Each hospital shall promptly submit a rate application to the Commission for a change in rates whenever the source of a hospital-based physician's or physician support personnel's compensation has been modified (for example, a hospital-based physician previously compensated by the hospital commences billing fee for service or CRNA's previously compensated by the hospital are replaced by physicians billing fee for service. B. Any rate application submitted under the requirements of §A, of this regulation, shall relate only to those changes in rates resulting from a modification in the source of a hospital-based physician's or physician support personnel's compensation. C. Failure to submit a rate application as required under §A, of this regulation, shall subject the hospital to overcharge/undercharge penalties, as specified in Regulation .05, of this chapter, as if those funds presently provided for in rates and obtaining to the source of a hospital-based physician's compensation had not originally been approved. #### Regulation .07 Change in Education Programs. *COMAR 10.37.03.07* A. Each hospital shall promptly submit a rate application to the Commission for a change in rates whenever an educational program conducted by the hospital has been modified (for example, the loss of a school of nursing program, the loss of resident/intern program, or a decrease in the number of students enrolled in the program). B. Any rate application submitted under the requirements of §A, of this regulation, shall relate only to those changes in rates resulting from a modification in an educational program conducted by a hospital. C. Failure to submit a rate application as required under §A, of this regulation, shall subject the hospital to the overcharge/undercharge penalties as specified in Regulation .05, of this chapter, as if those funds presently provided for in rates and obtaining to the hospital's educational program had not originally been approved. #### Regulation .08 Rates for Identified Physician Cost. *COMAR 10.37.03.08* A. Any hospital which incurs or accrues costs as a result of professional medical services which are personally rendered for an individual patient by a physician, and which contribute to the diagnosis or treatment of an individual patient, shall account for those costs as an Identified Physician Cost in accordance with the “Accounting and Reporting System for Hospitals” manual which is incorporated by reference in COMAR 10.37.01.02A(2). B. All those identified physician costs shall be charged to the individual patient as a separate charge and any bill rendered to a patient for those costs shall clearly and separately itemize those services and charges which are attributable to an identified physician cost. C. Any hospital may change without prior approval of the Commission its unit or rates for any identified physician cost as that center is defined in the Commission's “Accounting and Reporting System for Hospitals” and the Commission's “Rate Review System” which is incorporated by reference in COMAR 10.37.10.02B. D. The provisions of this regulation shall apply to all General Acute Care hospitals from October 1, 1983 and after that. #### Regulation .09 Rates for Non-Physician Services Provided to Hospital Inpatients by Third-Party Contractors. *COMAR 10.37.03.09* A. A non-physician inpatient service is defined as a hospital service under the jurisdiction of the Commission provided by a third-party contractor to a hospital inpatient off-site of the hospital. The charge for this service shall be billed by the hospital. B. The allowable rate shall be equal to or less than the Statewide median or price standard as developed by staff. C. The same rate on average shall be charged to all inpatients, regardless of payor. D. The sum of the rate charged to a hospital inpatient and the professional component, if any, on average, shall be not greater than that charged on average by the third-party contractor to its other patients for the sum of both components of the same service. E. The hospital shall provide an audit by an independent CPA that the contractor is in compliance with Sec. D of this regulation. F. The hospital shall be at risk for any payment made to a contractor in excess of the allowable charge determined in accordance with Sec. B of this regulation. G. The Commission shall waive COMAR 10.37.10.07A, which requires a rate application be filed at least 60 days before the opening of a new service, for rate applications approved under this regulation. H. The sections of this regulation are nonseverable and the entire regulation shall be null and void 60 days after a Court of competent jurisdiction rules that any portion or section of this regulation is beyond the jurisdiction of the Commission. #### Regulation .10 Rates for Services with Revenues Exempt from Commission Jurisdiction. *COMAR 10.37.03.10* A. Generally. The Commission may, on its own or upon application from a hospital, permit charges for services to be changed without its prior approval in those cases when 66-2/3 percent or more of the annual gross patient revenue attributable to the services is derived from either Medicaid or Medicare patients, or both, who are not required by State law or by the terms of the Medicare Waiver to pay Commission-approved rates for those services. The Commission shall consider this action only in those instances when the annual gross revenue for nonphysician services is not more than $20 million (in 1996 dollars), adjusted by an appropriate index of inflation, or when the annual gross revenue subject to Commission rate-setting jurisdiction is not more than $5 million (in 1996 dollars) adjusted by an appropriate index of inflation. B. Filing of Application. A hospital seeking a rate-setting exemption under this regulation shall file a written application with the Commission identifying the service or services for which the exemption is requested. The application shall contain accurate and supporting documentation that the conditions set forth in §A of this regulation have been met for a minimum period of 12 months immediately before the application. The filing of an application for a rate-setting exemption does not constitute a contested case within the meaning of that term as defined in the Administrative Procedure Act. C. Review of Application. The Commission staff shall review the application within a reasonable period of time and prepare a written recommendation on the request to the Commission. The decision to grant or deny the application rests within the sound discretion of the Commission. D. Required Reports. A hospital granted an exemption under this regulation is required to file quarterly reports, in a manner to be prescribed by the Commission, in order to verify that the conditions set forth in §A of this regulation still obtain. The hospital shall continue to file all other required reports in conformity with the Commission's Accounting and Budget Manual for Fiscal and Operating Management (the Manual), which is incorporated by reference under COMAR 10.37.01.02. E. Attestation. Responsible officials of an applicant hospital are required to attest that, to the best of their knowledge and belief, the reports filed, as required under §D of this regulation, have been prepared in conformity with the Commission's uniform accounting and financial reporting system as set forth in the Manual. F. Further Investigation. If the Commission considers a further investigation necessary or desirable to authenticate information reported by a hospital seeking a rate-setting exemption, the Commission may make any further examination of the records or accounts of the hospital in accordance with the rules or regulations of the Commission. G. Termination of Exemption. The Commission may terminate an exemption granted under this regulation at any time for cause. ### Chapter 04 — Submission of Hospital Outpatient Data Set to the Commission **Authority:** Health-General Article, §§19-207, 19-212, 19-215, and 19-216, Annotated Code of Maryland **Administrative History:** Effective date: December 2, 1996 (23:24 Md. R. 1682) **Administrative History:** Regulation .02B amended effective November 13, 2000 (27:22 Md. R. 2060) **Administrative History:** Regulations .03 and .04 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1182); amended permanently effective October 5, 1998 (25:20 Md. R. 1531) **Administrative History:** Regulation .03 amended effective September 3, 2001 (28:17 Md. R. 1556) **Administrative History:** Regulation .03B amended effective November 13, 2000 (27:22 Md. R. 2060; July 4, 2005 (32:12 Md. R. 1110) **Administrative History:** Regulation .04 amended effective November 13, 2000 (27:22 Md. R. 2060); September 3, 2001 (28:17 Md. R. 1556) **Administrative History:** Regulation .04G amended effective July 4, 2005 (32:12 Md. R. 1110) **Administrative History:** Regulations .01—.07 repealed effective June 4, 2007 (34:11 Md. R. 972) **Administrative History:** Regulations .01—.07 adopted effective June 4, 2007 (34:11 Md. R. 972) **Administrative History:** Chapter revised effective March 9, 2009 (36:5 Md. R. 422) **Administrative History:** Regulation .01A amended as an emergency provision effective January 1, 2014 (40:24 Md. R. 2014); amended permanently effective March 3, 2014 (41:4 Md. R. 301) #### Regulation .01 Collection and Submission of Data. *COMAR 10.37.04.01* A. Effective January 1, 2014, each hospital under the jurisdiction of the Health Services Cost Review Commission (Commission) shall submit the data elements as published in the Maryland Register and on the Commission's website (http://www.hscrc.maryland.gov) to the Commission within 15 days following the last day of the month during which the patient was discharged or died. The format for submission shall also be as published in the Maryland Register and on the Commission's website. B. A hospital under the jurisdiction of the Commission may apply to the Commission for an exception or an extension to the filing requirements of §A of this regulation as provided for in COMAR 10.37.01.02 and .03. #### Regulation .02 Definitions. *COMAR 10.37.04.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Health Services Cost Review Commission (Commission)” means the independent organization within the Maryland Department of Health that is responsible for reviewing and approving rates for hospitals pursuant to Health-General Article, §19-201 et seq., Annotated Code of Maryland. (2) “Hospital outpatient” means an encounter or visit to a hospital that does not result in an admission to the hospital. #### Regulation .03 Privacy of Information. *COMAR 10.37.04.03* Data submitted to the Commission in accordance with this chapter are not public information pursuant to Health-General Article, §19-207, Annotated Code of Maryland. #### Regulation .04 Summary Studies, Reports, Compilations. *COMAR 10.37.04.04* Summary studies, reports, or other compilations developed by the Commission or Commission staff from data submitted in accordance with this chapter shall be public information provided that, consistent with statutory law, disclosure is made in such a way that an individual patient or physician is not identified. #### Regulation .05 Corrections to Data. *COMAR 10.37.04.05* The Commission shall prescribe the process for hospitals to submit corrections and revisions to the data on its website. ### Chapter 05 — The Accounting and Budget Manual for Fiscal and Operating Management *Repealed* **Administrative History:** Effective date: July 7, 1976 (3:14 Md. R. 750) **Administrative History:** Regulation .01 adopted effective July 6, 1977 (4:14 Md. R. 1082) **Administrative History:** Regulations .02 and .03 adopted effective July 15, 1979 (6:12 Md. R. 1050) **Administrative History:** Chapter repealed effective July 20, 1981 (8:14 Md. R. 1227) ### Chapter 06 — Submission of Hospital Discharge Data Set to the Commission **Authority:** Health-General Article, §§19-207, 19-211, 19-212, 19-215, and 19-216, Annotated Code of Maryland **Administrative History:** Effective date: January 1, 1983 (9:16 Md. R. 1605) **Administrative History:** Regulation .02J, K repealed and new Regulation .02A, B(10) and (11) adopted effective July 1, 1985 (12:13 Md. R. 1280) **Administrative History:** Regulations .01—.06 repealed effective January 1, 1986 (12:22 Md. R. 2105) **Administrative History:** Regulations .01—.06 adopted effective January 1, 1986 (12:22 Md. R. 2105) **Administrative History:** Regulation .01 repealed and new Regulation .01 adopted effective February 28, 2005 (32:4 Md. R. 411) **Administrative History:** Regulation .01-1 adopted effective February 7, 2000 (27:2 Md. R. 145) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective April 1, 1993 (20:5 Md. R. 514) **Administrative History:** Regulation .02 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1183); amended permanently effective October 5, 1998 (25:20 Md. R. 1531) **Administrative History:** Regulation .02B amended effective September 1, 1986 (13:16 Md. R. 1827); November 3, 1986 (13:22 Md. R. 2400) **Administrative History:** Regulation .02B amended as an emergency provision effective November 17, 1986 (13:25 Md. R. 2653); emergency status expired March 1, 1987 **Administrative History:** Regulation .02B amended effective March 9, 1987 (14:5 Md. R. 580); August 1, 1994 (21:15 Md. R. 1306); December 4, 1995 (22:24 Md. R. 1894); February 10, 1997 (24:3 Md. R. 187); August 5, 2002 (29:15 Md. R. 1142); July 4, 2005 (32:13 Md. R. 1112); June 4, 2007 (34:11 Md. R. 972) **Administrative History:** Regulation .02B amended as an emergency provision effective July 1, 2007 (34:17 Md. R. 1506); amended permanently effective October 8, 2007 (34:20 Md. R. 1739) **Administrative History:** Regulation .03 repealed and new Regulation .03 adopted effective April 1, 1993 (20:5 Md. R. 514) **Administrative History:** Regulation .03 amended effective August 1, 1994 (21:15 Md. R. 1306); December 4, 1995 (22:24 Md. R. 1894); February 10, 1997 (24:3 Md. R. 187) **Administrative History:** Regulation .03 amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1183); amended permanently effective October 5, 1998 (25:20 Md. R. 1531) **Administrative History:** Regulation .03B, H amended as an emergency provision effective July 1, 2007 (34:17 Md. R. 1506); amended permanently effective October 8, 2007 (34:20 Md. R. 1739) **Administrative History:** Regulation .03F amended as an emergency provision effective November 17, 1986 (13:25 Md. R. 2653); emergency status expired March 1, 1987 **Administrative History:** Regulation .03F amended effective March 9, 1987 (14:5 Md. R. 580) **Administrative History:** Regulation .03G amended effective August 5, 2002 (29:15 Md. R. 1142) **Administrative History:** Regulation .03H amended effective July 4, 2005 (32:13 Md. R. 1112); June 4, 2007 (34:11 Md. R. 972) **Administrative History:** Regulation .06 amended as an emergency provision effective April 1, 1993 (20:5 Md. R. 514) **Administrative History:** Chapter revised effective March 9, 2009 (36:5 Md. R. 422) **Administrative History:** Regulation .01A, B amended as an emergency provision effective January 1, 2014 (40:24 Md. R. 2014); amended permanently effective March 3, 2014 (41:4 Md. R. 301) #### Regulation .01 Collection and Submission of Data. *COMAR 10.37.06.01* A. Beginning on January 1, 2014, each hospital under the jurisdiction of the Health Services Cost Review Commission shall submit to the Commission: (1) The data elements required by this chapter within 15 days after the last day of the month when the patient was discharged or died; and (2) The reconciliation of inpatient data between the discharge data and the financial data filed with the Commission. B. Submission Requirements. (1) The data elements submitted under §A(1) o this regulation shall be made in the form as published in the Maryland Register and on the Commission’s website (http://hscrc.maryland.gov). (2) The reconciliation submitted under §A(2) of this regulation shall be made in the manner, form, and time frame prescribed by Commission staff. C. A hospital may apply to the Commission for an exception or an extension to its filing requirements as provided in COMAR 10.37.01.02 and .03. D. Failure to submit the required data and reconciliation information in a timely manner may subject the hospital to monetary penalties as provided in Commission law and regulation. #### Regulation .01-1 Out-of-State Hospitals. *COMAR 10.37.06.01-1* A. The requirements for the collection and submission of data as described in Regulation .01 of this chapter shall also apply to those non-federal acute care hospitals located in Delaware, Pennsylvania, Virginia, West Virginia, and the District of Columbia. Data submitted by these non-Maryland hospitals shall relate exclusively to those patients who are Maryland residents. B. The Commission may consider these non-Maryland hospitals that otherwise provide discharge data as described in Regulation .04 of this chapter to the public to be exempt from the data requirements referred to in §A of this regulation. In addition, non-Maryland hospitals may apply to the Commission for an exception or an extension to either the form or to the manner of these data requirements as provided for in COMAR 10.37.01.02 and .03. C. If a non-Maryland hospital fails to submit discharge data on all Maryland patients as required by the Commission, the matter shall be referred by the Commission to Maryland's Medical Assistance Program for appropriate action. #### Regulation .02 Uniform Hospital Discharge Abstract Data Set. *COMAR 10.37.06.02* Data Elements are as published in the Maryland Register and on the Commission's website (http://www.hscrc.state. md.us). #### Regulation .03 Privacy of Information. *COMAR 10.37.06.03* Data submitted in accordance with this chapter are not public information pursuant to Health-General Article, §19-207(d), Annotated Code of Maryland. #### Regulation .04 Summary Studies, Reports, Compilations. *COMAR 10.37.06.04* Summary studies, reports, or other compilations developed by the Commission or its staff from the data submitted in accordance with this chapter shall be public information except that disclosure may not be made in a way that the data furnished by a specific patient can be identified. #### Regulation .05 Corrections to Data. *COMAR 10.37.06.05* The Commission shall prescribe the process for hospitals to submit corrections and revisions to the data on its website. ### Chapter 07 — Health Information Exchange Data **Authority:** Health-General Article, §§19-143, 19-207, 19-212, 19-215, and 19-216, Annotated Code of Maryland **Administrative History:** Effective date: September 19, 2011 (38:18 Md. R. 1077) #### Regulation .01 Purpose. *COMAR 10.37.07.01* The purpose of these regulations is to enable the Commission to fully measure and compare hospital-specific performance on readmissions and to use the data to further enhance and strengthen the financial incentives linked with performance. #### Regulation .02 Definitions. *COMAR 10.37.07.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Health Information Exchange (HIE)” means an infrastructure that provides organizational and technical capabilities for the exchange of protected health information electronically among entities not under common ownership. (2) “Health Services Cost Review Commission (Commission)” means the independent organization within the Maryland Department of Health that is responsible for reviewing and approving the rates for hospitals pursuant to Health-General Article, §19-201 et seq., Annotated Code of Maryland. (3) “Maryland Health Care Commission (MHCC)” means the agency established by Health-General Article, Title 19, Subtitle 2, Annotated Code of Maryland. (4) “Master Patient Index (MPI)” means an electronic database, created by the State-Designated HIE that maintains a unique index (or identifier) for every individual who has been, or who becomes, registered as a patient at a Maryland hospital. (5) “State-Designated HIE” means an HIE designated by the MHCC. #### Regulation .03 Hospital Participation. *COMAR 10.37.07.03* Effective December 1, 2011, each hospital under the jurisdiction of the Commission shall electronically connect to the State-Designated HIE to enable the Commission to fully measure hospital-specific performance on readmissions using the HIE’s MPI. #### Regulation .04 Method of Connection. *COMAR 10.37.07.04* Each hospital shall establish connectivity with the State-Designated HIE over a secure and encrypted connection. This connectivity shall be established using industry standards specified by the State-Designated HIE. #### Regulation .05 Collection and Submission of Master Patient Index Data. *COMAR 10.37.07.05* Each hospital under the jurisdiction of the Commission shall collect and electronically submit to the State-Designated HIE the data elements as published in the Maryland Register and on the Commission’s website (http://www.hscrc.state.md.us). The format and data time period for submission shall also be published in the Maryland Register and on the Commission’s website. #### Regulation .06 Privacy of Information. *COMAR 10.37.07.06* Data submitted in accordance with this chapter are not public information pursuant to Health-General Article, §19-207(d), Annotated Code of Maryland. The Commission will take reasonable steps to safeguard and protect the confidentiality of protected health information consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Maryland Confidentiality of Medical Records Act, and all other applicable State and federal laws and regulations. #### Regulation .07 Summary Studies, Reports, Compilations. *COMAR 10.37.07.07* Summary studies, reports, or other compilations developed by the Commission or its staff from the data submitted in accordance with this chapter shall be public information except that disclosure may not be made in such a way that the data furnished can lead to the identification of an individual. #### Regulation .08 Corrections to Data. *COMAR 10.37.07.08* The Commission shall prescribe on its website the process for a hospital to submit corrections and revisions to the data it has submitted. #### Regulation .09 Required Report. *COMAR 10.37.07.09* Data submitted in accordance with this chapter shall be considered a required report under COMAR 10.37.01.03N. ### Chapter 08 — Conduct of Public Meetings **Authority:** Health-General Article, §19-206, Annotated Code of Maryland **Administrative History:** Effective date: May 11, 1977 (4:10 Md. R. 767) #### Regulation .01 Frequency. *COMAR 10.37.08.01* Public meetings of the Commission may be held where and when the Commission directs for any authorized purpose, provided, however, that at least six meetings are held per year. #### Regulation .02 Attendance. *COMAR 10.37.08.02* A quorum need not be present in order for the Commission to hold a public meeting. If, however, less than a quorum is present at any public meeting, matters submitted for a vote shall be deferred. #### Regulation .03 Presiding Officer. *COMAR 10.37.08.03* The Chairman, or in his absence, the Vice-Chairman of the Commission or a designee shall preside at public meetings which may be called to order when the above presiding officer or his designee is in attendance. The Commission shall transact routine business and shall sit for the consideration of any and all matters which may properly be brought before it at the meeting. #### Regulation .04 Agenda. *COMAR 10.37.08.04* The Executive Director of the Commission in consultation with the Chairman shall be responsible for developing the agenda for each public meeting. #### Regulation .05 Records. *COMAR 10.37.08.05* Minutes of the meeting shall be taken by the Commission and made available for public inspection at the offices of the Commission, during ordinary business hours. #### Regulation .06 Voting. *COMAR 10.37.08.06* A. Each Commission member, except the Chairman, shall be entitled to one vote on each matter submitted to a vote at the meeting. B. Voting shall be in person or by proxy. C. The Chairman shall vote only to break a tie or cast a fourth concurring vote. D. During the time between public meetings, each Commission member shall be entitled to one vote on each matter submitted to vote. #### Regulation .07 Adjournment. *COMAR 10.37.08.07* A public meeting may be adjourned by a majority of those Commission members present in person. ### Chapter 09 — Fee Assessment for Financing Hospital Uncompensated Care **Authority:** Health-General Article, §§19-207, 19-207.1, 19-207.3, and 19-214, Annotated Code of Maryland **Administrative History:** Effective date: February 10, 1997 (24:3 Md. R. 188) **Administrative History:** Regulation .01 amended effective March 9, 1998 (25:5 Md. R. 369); May 31, 1999 (26:11 Md. R. 855) **Administrative History:** Regulation 01B amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423) **Administrative History:** Regulation 02 amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423) **Administrative History:** Regulation 03 amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423) **Administrative History:** Regulation .04A, C amended effective March 9, 1998 (25:5 Md. R. 369); May 31, 1999 (26:11 Md. R. 855) **Administrative History:** Regulation 04A, C amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423) **Administrative History:** Regulation .05 recodified to Regulation .06 and new Regulation .05 adopted effective March 9, 1998 (25:5 Md. R. 369) **Administrative History:** Regulation .05 amended effective May 31, 1999 (26:11 Md. R. 855) **Administrative History:** Regulation 05 repealed as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); repealed permanently effective March 9, 2009 (36:5 Md. R. 423) **Administrative History:** Regulation 06 amended as an emergency provision effective December 1, 2008 (36:2 Md. R. 97); amended permanently effective March 9, 2009 (36:5 Md. R. 423) #### Regulation .01 Definitions. *COMAR 10.37.09.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Automated clearing house (ACH)”, as defined in COMAR 03.01.02.01B, means a central clearing organization that operates as a clearing house for transmitting or receiving entries between banks and bank accounts, and authorizes an electronic transfer of funds between banks or bank accounts. (2) “Commission” means the Health Services Cost Review Commission. (3) “Comptroller” means the Comptroller of the Treasury or the Comptroller's designee. (4) “General Accounting Division” means the Fiscal Services Administration for the Maryland Department of Health. (5) “Health Services Cost Review Commission Fund” means the special fund established under Health-General Article, §19-207.1(d), Annotated Code of Maryland. (6) “Hospital” means an institution that is licensed by the Maryland Department of Health as an acute general hospital. (7) “Hospital Uncompensated Care Fund” means the monies that are collected from hospitals for the equitable financing of hospital uncompensated care and which are a discrete part of the Health Services Cost Review Commission Fund. (8) “Interest” means the investment earnings generated from the investment and reinvestment of the monies of the Hospital Uncompensated Care Fund which are separately held by the Treasury, accounted for by the Comptroller, and retained to the credit of the Health Services Cost Review Commission Fund. (9) “Mark-up” means the mechanism used to increase hospital rates to allow for payer differentials, working capital (prompt payment) differentials, and a provision for uncompensated care. (10) “Remittance” means the amount each hospital remits to the General Accounting Division pursuant to the predetermined formula established by the Commission to provide funding for the Commission's Hospital Uncompensated Care Fund. (11) “Special rate adjustment” means an adjustment to a hospital's rates, which will bring the hospital's uncompensated care provision of its mark-up to the Statewide uncompensated care average. (12) “Treasury” means the State Treasury. (13) “Wire transfer” means an electronic transaction in which a hospital, through the hospital's bank and an automated clearing house, originates an entry crediting the Health Services Cost Review Commission Fund's bank account and debiting the hospital's bank account on the same day the transaction is initiated. #### Regulation .02 Special Rate Adjustment and Collection. *COMAR 10.37.09.02* A. The Commission shall make a special rate adjustment to the uncompensated care provision of each hospital's mark-up to pay for the financing of the reasonable costs of hospital uncompensated care. The Commission shall notify hospitals in writing of the amount due to be remitted in a given month before the first day of that month. B. On or before the first business day of each month, the Commission shall direct the General Accounting Division to arrange for the collection of the amount due to be remitted by individual hospitals. This amount shall be based on the difference between a hospital's uncompensated care provision in its mark-up and the Statewide uncompensated care average. C. The Commission shall, at the same time, notify the General Accounting Division in writing of the: (1) Hospitals due to remit for that month; (2) Amount of the remittance for that month; (3) Hospitals to receive payments from the Hospital Uncompensated Care Fund for that month; (4) Amount to be disbursed to hospitals from the Hospital Uncompensated Care Fund in that month; and (5) The appropriate banking account information from each hospital in order to debit or disburse funds electronically by wire transfer. D. All funds collected shall be transferred to the Hospital Uncompensated Care Fund. #### Regulation .03 Payment of Remittance Due. *COMAR 10.37.09.03* A. By January 1, 2009, each hospital shall provide the Commission with sufficient banking information to facilitate the collection and disbursement of funds by the ACH or other wire transfer method. Each hospital shall initiate or authorize the ACH or other wire transfer method as directed by the Commission. B. On or before the 5th business day of each month, each hospital identified as due to remit monies in accordance with the provisions of these regulations shall make payment into the Hospital Uncompensated Care Fund in the manner prescribed by the Commission. C. On or before the 5th business day of each month, the Comptroller shall transfer monies out of the Hospital Uncompensated Care Fund and distribute monies to hospitals in the manner specified by the Commission. #### Regulation .04 Use of Funds. *COMAR 10.37.09.04* A. Funds generated through the special rate adjustment and the remittance due may only be used to finance the delivery of hospital uncompensated care. B. Interest earned from the monies collected shall be retained to the credit of the Hospital Uncompensated Care Fund. C. Interest earned may be used to pay for the reasonable expenses associated with implementation of the alternative methodology approved by the Commission for financing the reasonable costs of hospital uncompensated care. #### Regulation .05 Repealed. *COMAR 10.37.09.05* #### Regulation .06 Failures or Delay in Paying Remittance/Penalties. *COMAR 10.37.09.06* A. The Commission may impose penalties of up to 5 percent of the amount of an underpayment, unless an extension is granted as provided in §E of this regulation. B. A hospital that violates the provisions of Regulation .03 of this chapter shall, in addition to the penalties imposed under §A of this regulation, be subject to an annualized interest charge of 3 percentage points above the most recent average prime rate of interest, as published in the “Money Rates” section of the The Wall Street Journal, on the unpaid balance. C. In addition to the penalties the Commission may impose on a hospital that fails to pay the remittance in a timely manner, the Commission may refer the hospital's delinquent account to the Department of Budget and Fiscal Planning's Central Collection Unit pursuant to the procedures in State Finance and Procurement Article, Title 3, Subtitle 3, Annotated Code of Maryland. D. A hospital may file a written request with the Commission for a reasonable extension of time to make payment if the extension request is: (1) Made in writing to the attention of the Executive Director; (2) Supported by sufficient justification; and (3) Made at a reasonable time before the due date of a required payment. E. The Executive Director shall respond promptly in writing to the requesting hospital upon receipt of the request by either approving or disapproving the request. F. Extensions will be granted only for valid reasons. ### Chapter 10 — Rate Application and Approval Procedures **Authority:** Health-General Article, §§15-601 et seq. and 19-201, 19-207, 19-210—19-214, 19-214.1, 19-214.2, 19-214.3, 19-216—19-220, and 19-222; Insurance Article, §§14-501, 14-502, and 14-504; State Government Article, §10-304(b); Annotated Code of Maryland **Administrative History:** Effective date: November 7, 1974 (1:4 Md. R. 177) **Administrative History:** Regulation .16 amended effective August 20, 1975 (2:18 Md. R. 1234) **Administrative History:** Regulation .100 adopted effective December 10, 1975 (2:28 Md. R. 1680) **Administrative History:** Chapter revised effective October 27, 1976 (3:22 Md. R. 1250) **Administrative History:** Regulation .01 amended effective November 8, 2004 (31:22 Md. R. 1595) **Administrative History:** Regulation .01I, J adopted effective January 8, 1990 (16:26 Md. R. 2794) **Administrative History:** Regulation .01K adopted effective May 12, 2003 (30:9 Md. R. 615) **Administrative History:** Regulation .01-1 adopted effective October 5, 1998 (25:20 Md. R. 1531) **Administrative History:** Regulation .02B amended effective December 14, 1987 (14:25 Md. R. 2660) **Administrative History:** Regulation .03 amended as an emergency provision effective June 15, 1998 (25:14 Md. R. 1127); emergency status expired December 15, 1998 **Administrative History:** Regulation .03 amended effective August 5, 2002 (29:15 Md. R. 1142); January 15, 2018 (45:1 Md. R. 14) **Administrative History:** Regulation .03A amended as an emergency provision effective July 1, 2000 (27:17 Md. R. 1616); emergency status extended at 27:26 Md. R. 2356; emergency status extended at 28:7 Md. R. 687; emergency status expired July 1, 2001 **Administrative History:** Regulation .03A amended effective November 7, 2005 (32:22 Md. R. 1756); October 8, 2007 (34:20 Md. R. 1740); April 11, 2016 (43:7 Md. R. 450); January 16, 2017 (44:1 Md. R. 12); December 13, 2021 (48:25 Md. R. 1080) **Administrative History:** Regulation .03A amended as an emergency provision effective November 3, 2022 (49:25 Md. R. 1048); emergency provision expired May 1, 2023 **Administrative History:** Regulation .03A amended effective May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .03B amended effective September 1, 2003 (30:17 Md. R. 1203); March 15, 2004 (31:5 Md. R. 449) **Administrative History:** Regulation .03C adopted effective November 19, 1984 (11:23 Md. R. 1993) **Administrative History:** Regulation .03C amended effective October 3, 1988 (15:20 Md. R. 2334) **Administrative History:** Regulation .03D adopted effective January 8, 1990 (16:26 Md. R. 2794) **Administrative History:** Regulation .03D recodified as .03C effective August 5, 2002 (29:15 Md. R. 1142) **Administrative History:** Regulation .03D adopted as an emergency provision effective January 1, 2004 (31:4 Md. R. 313); adopted permanently effective May 10, 2004 (31:9 Md. R. 713) **Administrative History:** Regulation .03D amended as an emergency provision effective July 1, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1529) **Administrative History:** Regulation .03-1 adopted effective November 8, 2004 (31:22 Md. R. 1595) **Administrative History:** Regulation .03-1A amended effective January 15, 2018 (45:1 Md. R. 14) **Administrative History:** Regulation .03-1B amended effective May 8, 2006 (33:9 Md. R. 796); April 11, 2016 (43:7 Md. R. 450) **Administrative History:** Regulation .04 amended effective June 15, 1979 (6:12 Md. R. 1050) **Administrative History:** Regulation .04C adopted effective May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .04-1 adopted as an emergency provision effective October 8, 1998 (25:22 Md. R. 1650); adopted permanently effective February 8, 1999 (26:3 Md. R. 175) **Administrative History:** Regulation .04-1 amended as an emergency provision effective May 21, 2001 (28:13 Md. R. 1214); amended permanently effective September 3, 2001 (28:17 Md. R. 1557) **Administrative History:** Regulation .04-1 amended effective January 15, 2018 (45:1 Md. R. 14) **Administrative History:** Regulation .04-2 adopted effective November 13, 2000 (27:22 Md. R. 2060) **Administrative History:** Regulation .04-2 amended effective April 30, 2001 (28:8 Md. R. 760); January 15, 2018 (45:1 Md. R. 14) **Administrative History:** Regulation .04-2A, C amended effective January 12, 2009 (36:1 Md. R. 22) **Administrative History:** Regulation .04-2C amended effective October 9, 2006 (33:20 Md. R. 1617) **Administrative History:** Regulation .04-3 adopted effective November 13, 2000 (27:22 Md. R. 2060) **Administrative History:** Regulation .04-3 amended effective April 30, 2001 (28:8 Md. R. 760); January 15, 2018 (45:1 Md. R. 14) **Administrative History:** Regulation .05 amended as an emergency provision effective July 1, 2000 (27:17 Md. R. 1617); amended permanently effective November 13, 2000 (27:22 Md. R. 2060) **Administrative History:** Regulation .05 amended effective September 3, 2001 (28:17 Md. R. 1557) **Administrative History:** Regulation .05F amended as an emergency provision effective November 3, 2022 (49:25 Md. R. 1048); emergency provision expired May 1, 2023 **Administrative History:** Regulation .05F amended effective May 1, 2023 (50:8 Md. R. 338) **Administrative History:** Regulation .06E adopted effective August 28, 1995 (22:17 Md. R. 1318) **Administrative History:** Regulation .06E amended effective September 9, 1996 (23:18 Md. R. 1317); November 4, 1996 (23:22 Md. R. 1497); February 9, 1998 (25:3 Md. R. 146) **Administrative History:** Regulation .06E recodified to .06F and new .06E adopted effective October 5, 1998 (25:20 Md. R. 1531) **Administrative History:** Regulation .06F amended effective March 4, 2013 (40:4 Md. R. 346) **Administrative History:** Regulation .06G adopted effective October 9, 2006 (33:20 Md. R. 1617) **Administrative History:** Regulation .07 amended effective August 31, 1977 (4:18 Md. R. 1398) **Administrative History:** Regulation .07-1 adopted effective September 10, 2007 (34:18 Md. R. 1580) **Administrative History:** Regulation .07-1A amended effective December 13, 2021 (48:25 Md. R. 1080) **Administrative History:** Regulation .07-1C amended effective December 21, 2015 (42:25 Md. R. 1544); May 9, 2016 (43:9 Md. R. 530) **Administrative History:** Regulation .07-1E amended effective May 14, 2012 (39:9 Md. R. 612) **Administrative History:** Regulation .07-1K, L adopted effective December 13, 2021 (48:25 Md. R. 1080) **Administrative History:** Regulation .07-2 adopted effective January 16, 2017 (44:1 Md. R. 12) **Administrative History:** Regulation .10C amended effective April 9, 1984 (11:7 Md. R. 626); March 8, 1999 (26:5 Md. R. 391); December 21, 2015 (42:25 Md. R. 1544) **Administrative History:** Regulations .11C and .12B amended effective May 29, 1981 (8:11 Md. R. 975) **Administrative History:** Regulation .11G adopted effective January 15, 2018 (45:1 Md. R. 14) **Administrative History:** Regulation .13B amended effective September 19, 1980 (7:19 Md. R. 1806) **Administrative History:** Regulation .13H adopted effective July 28, 1978 (5:15 Md. R. 1190) (originally codified as Regulation .12G) **Administrative History:** Regulation .14I amended effective December 12, 2002 (29:24 Md. R. 1919) **Administrative History:** Regulation .20 amended effective April 9, 1984 (11:7 Md. R. 626); March 8, 1999 (26:5 Md. R. 391) **Administrative History:** Regulation .23 amended effective May 11, 1977 (4:10 Md. R. 767) **Administrative History:** Regulation .25I adopted effective May 9, 1983 (10:9 Md. R. 791) **Administrative History:** Regulation .26 amended as an emergency provision effective June 19, 2009 (36:15 Md. R. 1163); amended permanently effective October 5, 2009 (36:20 Md. R. 1530) **Administrative History:** Regulation .26 amended effective November 15, 2010 (37:23 Md. R. 1611); December 11, 2025 (52:24 Md. R. 1198) **Administrative History:** Regulation .26A amended effective July 1, 1988 (15:13 Md. R. 1555); April 3, 1989 (16:6 Md. R. 728); November 26, 1990 (17:23 Md. R. 2732); March 30, 1992 (19:6 Md. R. 674); June 7, 1993 (20:11 Md. R. 913); July 5, 1993 (20:13 Md. R. 1049); August 1, 1994 (21:15 Md. R. 1306) **Administrative History:** Regulation .26A amended as an emergency provision effective June 1, 1996 (23:13 Md. R. 938); emergency status expired November 13, 1996 **Administrative History:** Regulation .26A amended December 30, 1996 (23:26 Md. R. 1860) **Administrative History:** Regulation .26A amended as an emergency provision effective November 24, 1997 (24:26 Md. R. 1752); emergency status extended to August 31, 1998 (25:12 Md. R. 943); emergency status extended to October 31, 1998 (25:18 Md. R. 1431) **Administrative History:** Regulation .26A amended October 5, 1998 (25:20 Md. R. 1531) **Administrative History:** Regulation .26A amended as an emergency provision effective February 25, 1999 (26:6 Md. R. 480); amended permanently effective June 28, 1999 (26:13 Md. R. 1020) **Administrative History:** Regulation .26A amended as an emergency provision effective June 26, 2000 (27:15 Md. R. 1397); amended permanently effective November 13, 2000 (27:22 Md. R. 2060) **Administrative History:** Regulation .26A amended as an emergency provision effective December 6, 2000 (28:3 Md. R. 203); amended permanently effective April 30, 2001 (28:8 Md. R. 760) **Administrative History:** Regulation .26A amended effective October 29, 2001 (28:21 Md. R. 1856); May 13, 2002 (29:9 Md. R. 745) **Administrative History:** Regulation .26A repealed effective September 1, 2003 (30:17 Md. R. 1203) **Administrative History:** Regulation .26A amended effective November 15, 2010 (37:23 Md. R. 1611); August 6, 2012 (39:15 Md. R. 963); May 6, 2019 (46:9 Md. R. 445); April 5, 2021 (48:7 Md. R. 259) **Administrative History:** Regulation .26A-2 amended effective December 10, 2012 (39:24 Md. R. 1577); April 5, 2021 (48:7 Md. R. 259) **Administrative History:** Regulation .26A-3 adopted effective April 5, 2021 (48:7 Md. R. 259) **Administrative History:** Regulation .26B amended effective October 3, 1988 (15:20 Md. R. 2334); May 29, 1989 (16:10 Md. R. 1109); May 14, 1990 (17:9 Md. R. 1092); August 1, 1994 (21:15 Md. R. 1306); March 11, 1996 (23:5 Md. R. 380); September 30, 2002 (29:19 Md. R. 1524); April 10, 2006 (33:7 Md. R. 673); April 5, 2010 (37:7 Md. R. 572); August 4, 2014 (41:15 Md. R. 891) **Administrative History:** Regulation .26C adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 677); emergency status expired July 22, 1998; adopted permanently effective September 7, 1998 (25:18 Md. R. 1435) **Administrative History:** Regulation .26-1 adopted effective May 12, 2003 (30:9 Md. R. 615) **Administrative History:** Regulation .26-1 amended as an emergency provision effective June 12, 2008 (35:14 Md. R. 1244); amended permanently effective October 6, 2008 (35:20 Md. R. 1775) **Administrative History:** Regulation .26-1B amended as an emergency provision effective March 21, 2014 (41:8 Md. R. 468); emergency status extended to August 1, 2014 (41:15 Md. R. 888); amended permanently effective July 7, 2014 (41:13 Md. R. 753) **Administrative History:** Regulation .26-1 amended as an emergency provision effective July 1, 2015 (42:16 Md. R. 1053); amended permanently effective November 9, 2015 (42:22 Md. R. 1378) **Administrative History:** Regulation .26-2 adopted effective March 9, 2009 (36:5 Md. R. 423) **Administrative History:** Regulation .27A amended effective February 18, 2002 (29:3 Md. R. 221) **Administrative History:** Regulation .100 recodified as Regulation .33 **Administrative History:** Regulation .34 adopted effective August 1, 1987 (14:15 Md. R. 1660) **Administrative History:** Regulation .35 adopted effective August 1, 1987 (14:15 Md. R. 1660) **Administrative History:** Regulation .36 adopted effective August 1, 1987 (14:15 Md. R. 1660) #### Regulation .01 Definitions. *COMAR 10.37.10.01* A. “Burden of proof” means the burden of persuasion by the preponderance of the evidence. B. “Commission” means the Health Services Cost Review Commission. C. “Executive Director” means the Executive Director of the Commission, or in his absence, the Commission staff member designated to act in his stead. D. “Opinion” means a written statement setting forth the reasons and grounds why the writer of the statement believes that certain actions should be taken or decisions or recommendations made. E. “Order Nisi” means an order of the Commission that certain actions shall be taken or that certain matters are approved as of a future date, thereby permitting parties affected by the Order Nisi to make any objections they may have known to the Commission. F. Partial Rate Application. (1) “Partial rate application” means a request by a hospital for the amendment or establishment of a single approved rate. (2) “Partial rate application” includes, but is not limited to, those requests enumerated in Regulation .03B(4) of this chapter. G. “Publish” means the insertion of a public notice concerning proposed actions, including but not limited to public hearings, in a newspaper or newspapers in general circulation in the community in which the hospital affected is located, and, if the public notice relates to a public hearing, in the Maryland Register at least 15 days before the date of the public hearing. H. “Rate application” and “application” mean a hospital application for rate approval, to be submitted as specified in these regulations. I. “Recommendation” means a written statement from the Commission's staff to the Commission, advocating a resolution of issues or approval, disapproval, or modification of certain hospital rates and procedures for evaluating the rates. J. “Regression analysis” means a statistical technique used to measure and control for the effect of selected independent variables (for example, percentage of Medicaid revenue) on one dependent variable (for example, bad debts). K. “Uncompensated care” means care provided for which compensation is not received (that is, any combination of bad debts and charity care), and as more fully described in the Commission's Accounting and Budget Manual for Fiscal and Operating Management which is incorporated by reference at COMAR 10.37.01.02. L. “Value of the substantial, available, and affordable coverage (SAAC) differential” means the difference between the amount paid out by SAAC-approved nonprofit health service plans, health insurers, and health maintenance organizations on behalf of SAAC enrollees to hospitals, and what they would have paid to hospitals absent the differential. #### Regulation .01-1 Incorporation by Reference. *COMAR 10.37.10.01-1* The Alternative Rate Setting Method (ARM) Manual (1998) is hereby incorporated by reference. #### Regulation .02 Rate Review System. *COMAR 10.37.10.02* A. The rate review system, otherwise known as the Accounting and Budget Manual for Fiscal and Operating Management, shall consist of: (1) The rate review forms; and (2) Instructions for completion of the forms. B. The rate review system is incorporated by reference in COMAR 10.37.01.02. C. A hospital's rate review system and a schedule of published rates shall be filed by the last day of the third month after the close of the hospital's fiscal year. #### Regulation .03 Regular Rate Applications. *COMAR 10.37.10.03* A. A hospital may not file a full rate application with the Commission until the Commission staff is able to determine through analysis that the data used to evaluate a full rate application has not been substantially affected by the COVID pandemic. During this interim period, a hospital may seek a rate adjustment under any other administrative remedy available to it under existing Commission law, regulation, or policy. In no event shall this moratorium continue in effect beyond June 30, 2023. Once the moratorium is lifted, a hospital may file a regular rate application at any time if: (1) The rates being requested are not the subject of a hospital-instituted case pending before the Commission; or (2) The subject hospital has not obtained permanent rates through the issuance of a Commission rate order within the previous 365 days. B. Full Rate Application. (1) “Full rate application” means a regular rate application which requests the amendment of more than one previously approved rate. (2) In order for a full rate application to be docketed, it shall comply with a template for such applications as prescribed by the Commission staff and shall: (a) Enumerate the services for which new rates are being requested, listing present and proposed rates; (b) Be accompanied by appropriate supporting documents, including: (i) The Annual Report of Revenues, Expenses, and Volumes projected and explained (e.g., how much of the requested increase relates to inflation, volumes, and other factors) for the period for which the hospital requests new rates; (ii) Any audited financial statements over the most recent 5 years not yet filed with the Commission, plus the most recent unaudited financial statements for the current period, which are available at the time of the filing of the full rate application; (iii) An Excel file listing and summarizing balance sheets, statements of operations and changes in net assets, and statements of cash flow for the last 5 years per the audited financial statements along with a narrative explaining any major changes; (iv) An Excel file listing the information contained within the Annual Report RE schedules for the last 5 years breaking out regulated and unregulated revenues and expenses by category and in total; (v) A detailed history of HSCRC-approved revenue and actual revenue for the hospital for the last 2 calendar years; (vi) A detailed history for the most recent 4 Rate Years of HSCRC-approved GBR revenue and actual revenue and volumes, in addition to any approved and actual revenue and volumes available at the date of the filing of the full rate application. The history of approved and actual revenue changes should detail the basis of the changes in approved and actual revenue including allowed inflation and all other factors; (vii) An identification of related organizations (i.e., an organization related to the hospital through some type of control or ownership), including subsidiaries of the hospital as well as hospitals that are part of the same hospital system as the applicant hospital. For applicant hospitals that are part of a system, the hospital may be required to submit financial and other information related to the system hospitals, including any system transactions among the system hospitals, which may affect the financial condition of the applicant hospital; (viii) A listing of any services provided by related organizations including the amount charged to the applicant hospital for the services; (ix) A listing of any transfers of funds to or from a related organization including an explanation of such transfers; (x) Copies of the two most recent Medicare Cost Reports, including any home office cost report files — the Interns and Resident Information System report (IRIS) files, and the wage and occupational mix files, along with any adjustments and corrections; (xi) Reconciliations of inpatient and outpatient volumes and revenue submitted in the HSCRC abstract data to the departmental revenue and statistics submitted monthly for the last 3 years; (xii) In Excel, listing of Outpatient drugs accounting for at least 80 percent of the Hospital’s total outpatient drug expenses, with applicable HCPCS codes for last 3 years, including frequency of charges, amount of charges and units billed, Average Sales Price at the end of each year and applicable 340B discounts and an estimate of billed charges for unlisted drugs; (xiii) For profits or losses associated with the support of physician practices, the applicant hospital may be required to provide a detailed accounting of those profits or losses over time. Additional information regarding compensation, subsidies and other forms of financial support provided to physicians may be required following staff’s initial review to the extent that these profits or losses have a material impact on the financial condition of the applicant hospital; (xiv) A supporting document, in Excel, that compares the requested departmental rates of the applicant hospital to that hospital’s current departmental rates. The supporting document should also compare these current and requested departmental rates to those of other HSCRC-regulated hospitals located in the Primary Service Area (PSA) of the applicant hospital. If no other regulated hospitals are located in the applicant hospital’s PSA, then the comparison should be made to Statewide median departmental rates; and (xv) An accounting of the amounts reported by the applicant hospital to the HSCRC regarding its uses of population health infrastructure money included in rates; (c) Include a description of the rate adjustments that are being requested in the full rate application; (d) Include specific detail and substantiation of any circumstances the applicant hospital cites as unique to its facility, which would require revenue in excess of the amount currently provided in its approved regulated revenue; (e) Describe in detail what the applicant hospital has specifically done consistent with the All-Payer Model to reduce or eliminate unnecessary or potentially avoidable utilization. For purposes of this regulation, unnecessary or potentially avoidable utilization means the utilization of health care items and services, including care furnished to treat complications during a hospital admission, that may be avoided through improved efficiency, care coordination, or effective community-based care, or that is not medically necessary or evidence-based care. The Staff may request additional information as needed; (f) Provide estimates for the next 5 years of reductions in utilization that will be accomplished through care redesign initiatives; (g) Provide a history of denials for the most recent 3 years, including any year-to-date figures; and (h) Any additional information the Staff may request that bears directly on the hospital’s request for rate relief and its financial condition. (3) The provisions of §B(2) of this regulation may be waived by staff if the application applies only to: (a) A request filed for a change in the applicant hospital’s uncompensated care allowance; (b) A request for rates to cover government-mandated or similar action affecting more than one previously approved rate for which the staff believes the provisions of §B(2) of this regulation are not necessary; or (c) A request for rates associated with a Certificate of Need-approved capital project, which request may be considered to be a “partial rate application” by staff. C. Uncompensated Care Policy. (1) The Commission's rate-setting methodology shall include in the rates of each hospital a provision for a reasonable level of uncompensated care provided at the hospital. The Commission may use a regression analysis or other statistical method to establish the reasonable level of uncompensated care. (2) In establishing a reasonable level of uncompensated care in a full rate review, the Commission shall consider for each hospital the: (a) Amount of uncompensated care actually incurred; (b) Predicted amount of uncompensated care; and (c) The hospital's requested amount. (3) A hospital may request a change in its approved provision of uncompensated care to the predicted amount by means of a partial rate application provided the request is revenue neutral. #### Regulation .03-1 Partial Rate Application. *COMAR 10.37.10.03-1* A. The provisions of Regulation .03B(2) of this chapter may be waived by staff in the review of a partial rate application. B. A hospital may file a partial rate application with the Commission at any time, consistent with the provisions of Regulation .03A of this chapter. A partial rate application is not a contested case under the provisions of the Administrative Procedure Act. C. The Commission shall act on a docketed partial rate application within the time frames established for a full rate application that does not involve a public hearing, consistent with Commission law and regulation. D. A hospital that has been denied its request for a partial rate change may file a full rate application with the Commission in accordance with Commission law and regulation. #### Regulation .04 Commission Review of Established Rates. *COMAR 10.37.10.04* A. The Commission may order a review of a hospital's established rates at any time, as it deems necessary and proper. B. This order, provided it orders the review of any rate or charge, may constitute a Commission-initiated rate proceeding. C. In reviewing a hospital’s established rates during a Commission-initiated rate proceeding or while reviewing a hospital’s full rate application, the Commission shall consider the hospital’s performance since the implementation of the All-Payer Model Agreement with the federal government, which took place in February 2014. #### Regulation .04-1 Rate Efficiency Methodology. *COMAR 10.37.10.04-1* A. In evaluating the reasonableness of a hospital's permanent rate structure, the Commission shall use an Inter-hospital Cost Comparison (ICC) methodology, which compares the costs of the hospital to those costs, including adjustments for reasonableness and efficiency, of its peer hospitals, with appropriate adjustments to reflect changes in the hospital’s volume since the beginning of the new All-Payer Model Agreement and the inception of the hospital’s revenue agreement, as the foundation of its review of the full rate application. The staff shall make modifications to the ICC which are needed to properly reflect any additional factors that are relevant to the determination of a reasonable cost level that should be reflected in the hospital’s approved regulated revenue. The ICC analysis does not constitute a strict, unalterable or absolute methodology. It shall be modified as needed to give proper attention to the particular circumstances of the hospital, and the staff shall give due consideration to information provided by the hospital in determining the appropriate rate levels and rate structure for the hospital. The ICC shall take into account, in the establishment of appropriate rate levels, those factors for which the hospital will not be held accountable such as special grants from the Commission, assessments, uncompensated care levels, and characteristics of the population in the hospital’s primary service area. B. Factors considered in the ICC methodology may evolve during the course of full rate reviews. The Commission shall take into account the specific circumstances of the applicant hospital, and staff shall make the key contents, analytic steps, and findings of such reviews available to all hospitals and the public. C. When reviewing a full rate application filed by a hospital that is owned or controlled by a hospital system that also owns other hospitals located in Maryland, the Commission may take into account the financial situation of the other hospitals in the system including their profitability and any shifts of services, volume, revenues or assets between the hospital and the other hospitals or related organizations of the system. D. The final rates that are approved by the Commission for a nonprofit hospital’s permanent rate structure shall allow the hospital to charge reasonable rates that will permit it to provide, on a solvent basis, effective and efficient service that is in the public interest. E. The final rates that are approved by the Commission for a proprietary profit-making hospital’s permanent rate structure shall allow the hospital to charge reasonable rates that will permit it to provide effective and efficient service that is in the public interest and include enough allowance for and provide a fair return to the owner of the hospital. F. The Commission shall set rates for the applicant hospital consistent with the All-Payer Model approved by the federal Center for Medicare and Medicaid Innovation. #### Regulation .04-2 Global Budget Revenue Methodology. *COMAR 10.37.10.04-2* A. The Global Budget Revenue (GBR) methodology implemented by the Commission effective January 1, 2014, establishes reasonable revenue levels for Maryland's general acute hospitals, which will enable them to improve quality and efficiency on a solvent basis within the constraints imposed by the All-Payer Model. B. In setting reasonable revenue levels, the Commission shall take into account a number of factors. These may include, but are not limited to the following: (1) The casemix severity and reasonable utilization of the hospital’s patients; (2) The historical charges of the hospital; (3) The statutory requirement regarding the reasonable relationship between costs and charges; (4) The hospital’s payer mix; (5) The reasonable uncompensated care requirements of the hospital; (6) The reasonable Graduate Medical Education (GME) costs of the hospital as determined by the Commission; (7) Appropriate adjustments, if any, associated with exceptional or outlier cases as defined by the Commission; (8) Wage levels at the hospital and at other hospitals in the geographic area of the hospital and elsewhere in Maryland; (9) Adjustments for quality improvement and value-based payment programs applicable to the hospital; (10) Reasonable infrastructure funding for care management and care coordination for hospital patients; (11) The annual update factor; (12) The proportion of unnecessary care, including Potentially Avoidable Utilization (PAU) at the hospital; and (13) The performance of the State as a whole under the All-Payer Model. C. The GBR shall be implemented through a written agreement entered into by the Commission and each individual general acute hospital. This agreement and any addenda thereto, which shall be annual and renewed automatically, shall set forth all relevant provisions governing the GBR including, but not limited to, performance corridors; interim rate adjustments; the exclusion or special treatment of certain cases; the treatment of volume changes, including those involving residents of Maryland and other patients; the penalties associated with failure to comply with the terms of the GBR agreement; interim revenue limits; care redesign requirements; and other changes to the agreement that may be needed from time to time. A hospital that enters into a GBR agreement shall submit a signed copy of the agreement to the Commission’s offices within 60 days after it is initially approved by the Commission. A hospital that is party to the addendum shall submit a signed copy of the addendum to the Commission’s offices within 60 days from the issuance of the addendum. Failure to submit the signed GBR agreement or the signed addendum in a timely manner, absent an extension granted by staff, may subject the hospital to penalties under COMAR 10.37.01.03R. Thereafter, on an annual basis, the hospital shall receive an updated rate order. A hospital that disagrees with a proposed GBR may file a full rate application with the Commission in accordance with Regulation .03 of this chapter. #### Regulation .04-3 Global Budget Revenue Mechanism. *COMAR 10.37.10.04-3* A. For purposes of this regulation, the following definitions apply: (1) “Annual update factor” means the amount by which total State hospital revenue may increase in a rate year. (2) “Demographic adjustment” means the percentage increase in allowed revenue related to changes in population and the age/sex mix of the population residing in the hospital’s primary service area, net of any reductions. (3) “Factor cost inflation” means increases in the costs of goods, services, wages, and salaries experienced by the hospitals as calculated by the Commission for the most recent period for which data are available preceding the year for which the Commission calculates case target updates. (4) “Hospital update” means the amount by which an individual hospital’s approved GBR revenue changes in a particular rate year (i.e., July 1—June 30). (5) “Market shift adjustment” means the rate adjustment applied by the Commission, which increases or decreases the approved GBR revenue of a hospital to reflect changes in volume at the hospital for which there was a corresponding change in volume at another Maryland hospital or other provider. B. Annual Update Factor. (1) On or before July 1 of each year, the Commission shall establish an annual update factor for the purpose of adjusting the GBR revenue of each individual hospital. The annual update factor shall be designed to reflect projected factor cost inflation, an allowance for certain volume adjustments, productivity adjustments, the revenue constraints included in the All-Payer Model Agreement and other relevant factors, demographic adjustments, market shift adjustments, and other appropriate adjustments. (2) If after approving an update factor for a given year, a hospital or hospitals collectively exceed their approved revenue, the annual update factor may be reduced in future years to recoup the excess revenue growth. Similarly, if a Maryland hospital or hospitals collectively fall below their approved revenue for a given year, the annual update factor may be adjusted accordingly in future years. (3) If Maryland hospitals accrue a national growth reduction for 2 consecutive years, in the following year the annual update factor shall be reduced by the first of the 2-year national growth reduction. Except as provided in §D of this regulation, the annual update may not be less than 1 percent. C. The technical provisions of the methodology used to convert the annual update factor into the hospital update for the next rate year shall be fully described and publicly disseminated on or before July 1 of each year, allowing sufficient time for comment and implementation. D. Corrective Action. If, at any time, the Commission estimates that the financial constraints or other terms imposed by the All-Payer Model Agreement are at risk of being violated (based on modelling using the CMS actuary’s most recent projections and Health Services Cost Review Commission analysis of Medicare payments data), the Commission may take immediate and appropriate corrective action as it deems necessary and proper to meet the Medicare savings requirements and limits on growth in Medicare payments and prevent any further deterioration in compliance with the Model Agreement. The Commission shall provide sufficient notice and opportunity for comment before taking corrective action. This comment opportunity does not constitute a contested case within the meaning of the Administrative Procedure Act. E. The provisions of this regulation apply to all Maryland's general acute care hospitals from July 1, 2014, and thereafter. F. Compliance and Penalties. GBR compliance shall be monitored during the agreement period. Penalties shall be assessed prospectively at the beginning of the next period. Penalties shall be based on the corridors specified in the GBR Agreement. #### Regulation .05 Application for Temporary Change in Rates. *COMAR 10.37.10.05* A. The Commission may issue a general notice setting forth circumstances under which a hospital may obtain a temporary change in rates. The rates, if approved or modified, shall be effective before the rate review procedure set forth in these regulations, but not before the date of application. B. A hospital may apply at any time for a temporary change in rates provided that one of the following conditions is satisfied: (1) A decline in the hospital's experienced or projected net revenues, due to factors beyond the hospital's control, requiring funds beyond those normally available; (2) An increase in the hospital's experienced or projected expenses, due to factors beyond the hospital's control, requiring funds beyond those normally available; or (3) A hospital's expenses from regulated services exceed its revenues from regulated services, or the hospital's financial integrity is otherwise jeopardized (for example, for breaching its bond covenants). C. The Commission and its staff shall review the application and consult with the hospital as to the necessity for the temporary change in rates and the amount of the change required. Designated interested parties shall have 6 working days from the filing of the application to submit comments to the Commission. D. Within 12 working days from the filing of the application, the Commission shall issue its order: (1) Denying the temporary change in rates and stating the grounds therefor; or (2) Granting a temporary change in rates, stating: (a) The amount of the temporarily changed rates, which may or may not be the same as the rates set forth in the hospital's application; (b) The necessity for the temporary change in rates; (c) That a regular rate review proceeding on the proposed rates will be conducted by the Commission as soon as practicable; (d) The availability of copies of the order at the offices of the Commissioner; and (e) The availability of the record of the temporary rate application for inspection at the Commission's office during ordinary business hours. E. The Commission order denying or granting the temporary change in rates shall be published and copies forwarded to: (1) The hospital; (2) Designated interested parties; and (3) Persons writing to the Commission requesting a copy of the order. F. In conducting an expedited review to establish a temporary rate for both inpatient and outpatient services, the Commission shall consider the hospital’s financial condition in addition to its relative efficiency and effectiveness in its performance under the Total Cost of Care Model. A temporary rate approved by the Commission may not result in regulated revenue exceeding regulated expenses in the most recently completed fiscal year. G. A temporary change in rates is subject to the Commission's final rate order in the regular rate review proceeding, which may be effective as of the date of the temporary rate order. #### Regulation .06 Application for Alternative Method of Rate Determination. *COMAR 10.37.10.06* A. At any time on or after July 1, 1974, a hospital may file a written application with the Commission requesting an alternative method for submitting or reviewing any or all of its rates and charges, specifying the reasons for and details of the alternative methods. B. If warranted by the circumstances set forth in the application, the Executive Director may grant a temporary approval of an alternative method of rate determination. C. The procedure for submitting and reviewing an application under an alternative method of rate determination shall follow as closely as possible the procedure for a regular rate application, except that the time periods and limitations set forth in these regulations do not apply to an application for an alternative method of rate determination. D. At anytime after the approval of an alternative method of rate review by the Executive Director, the Commission may initiate further proceedings to determine the hospital's continuing qualification for the alternative method of rate determination. E. ARM System. (1) The Commission may implement a system providing for alternative rate setting methods (ARM) which would permit hospitals to accept financial risk for the provision of hospital services under certain conditions and circumstances. (2) The implementation of an ARM system shall be consistent with the principles of equity and access embodied in the Commission's all-payer rate setting system. (3) The ARM Manual shall set forth the process and requirements associated with the ARM system. F. Required Reports under ARM System. (1) A hospital granted approval for an alternative method of charging under this regulation is required to file quarterly reports and annual reports, to include but not be limited to those listed below in this section, in order to determine that the hospital continues to qualify for the alternative method of rate determination. (2) Quarterly Reports. The following reports shall be completed in the form prescribed by the Commission and submitted to the Commission within 30 days after the end of each hospital's calendar quarter: (a) Statistical Data Summary—Each Capitation or Risk-Sharing Contract; (b) Statistical Data Summary—Each Fixed-Price Contract; (c) Statistical Data Summary—Other; (d) Revenue Summary—Each Capitation or Risk-Sharing Contract; (e) Revenue Summary—Each Fixed-Price Contract; and (f) Revenue Summary—Other. (3) Annual Reports. The following annual reports shall be completed in the form prescribed by the Commission and submitted to the Commission within 90 days after the end of the appropriate fiscal year: (a) Statement of Revenue and Expense—Each Capitation or Risk-Sharing Contract; (b) Statement of Revenue and Expense—Each Fixed-Price Contract; (c) Statement of Revenue and Expense—Other; (d) Audited Statement of Revenue and Expense—Contracting Entity; and (e) Audited Balance Sheet—Contracting Entity. (4) Filing of Reports/Extension. (a) A hospital required to file the reports in this section may request a reasonable extension of time for filing, if the extension request is: (i) Made in writing to the attention of the Executive Director; (ii) Supported by sufficient justification; and (iii) Made at a reasonable time before the due date of a required report. (b) The Executive Director shall respond promptly in writing to the requesting hospital upon receipt of the request by either approving or disapproving the request. (c) Extensions will be granted only for valid reasons. (d) Any required report submitted by a hospital that is substantially incomplete or inaccurate shall be considered untimely filed. (5) Time for Filing. An application for an alternative rate application shall be filed at least 30 days before the proposed effective date of the alternative rate. (6) Penalties. (a) The Commission may impose penalties of up to $1,000 per day for failing to file reports as required under this section. (b) The Commission may refuse to grant a rate increase to a hospital that does not file a report as required under this section. (c) A fine assessed for failure to file an alternative rate application on a timely basis shall begin as of the date the application should have been filed. G. Funding for Health Information Technology. (1) The Commission may adjust a hospital's rates for health information technology (HIT) projects in conjunction with action taken by the Maryland Health Care Commission (MHCC) under COMAR 10.25.13. (2) Upon receipt of a recommendation for funding from the MHCC, the Commission's staff shall: (a) Review the information presented; (b) Consult with appropriate parties; and (c) Recommend to the Commission approval, denial, or modification of the MHCC recommendation. (3) In deciding the course of action to follow on an MHCC HIT project recommendation, the Commission and its staff shall consider, among other things, the following criteria: (a) The basis for the MHCC recommendation; (b) The applicant's statement of the purpose, mission, vision, goals, and measurable objectives of the project; (c) The planned approach, including: (i) An explanation of how the project's goals and objectives will be met; (ii) The technical strategy of the project; (iii) What activities will be used; (iv) What personnel will be needed; and (v) How that personnel will be utilized; (d) How the project will be evaluated, as well as specific measurement strategies; (e) A timeline that includes the start and end dates of the project and a schedule of activities; (f) The credentials of the entity and participating individuals, including information that demonstrates their background and ability to carry out the project successfully; (g) The potential of the project to enhance the value of health care in Maryland, such as improving health care outcomes and reducing health care costs; (h) Information that demonstrates why the project is needed; and (i) A budget that details cost projections for the project that is specific, reasonable, realistic, accurate, and flexible. (4) Decision. (a) Based on its consideration of the above-stated criteria and staff's recommendation, the Commission shall decide on the nature, extent, terms, and conditions of any rate adjustment approved. (b) The decision of the Commission on an MHCC recommendation for HIT funding is final. (c) A request for funding under this section is not a contested case under the Administrative Procedure Act. #### Regulation .07 Rate Applications by New Hospitals or Existing Hospitals with Expanded Facilities or New Revenue Centers. *COMAR 10.37.10.07* A. At least 60 days before the operational opening of a new hospital, a revenue center, or a new service within a hospital whose projected annual operating cost exceeds $100,000, the hospital shall file a rate application for the requested rates. This application shall be supported by financial data presented in the format of the Commission's rate review system. B. If an existing hospital expends its operations so that the number of in-patient beds is increased by 20 percent or more, and if a rate application is filed pertaining to the expended facilities and providing for an occupancy rate for the expanded facilities of the hospital at an amount below the target occupancy established by the Commission, the Commission may require the filing of additional information projecting the hospital's expanded facilities' activity levels for the first 5 years of their operation. #### Regulation .07-1 Outpatient Services — At the Hospital Determination. *COMAR 10.37.10.07-1* A. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Terms Defined. (a) “At the hospital” means a service provided in a building on the campus of a hospital in which hospital services are provided. (b) “Health care provider” means an individual who is licensed, certified, or otherwise authorized by law to provide health care services under Health Occupations Article, Annotated Code of Maryland. (c) “Telehealth services” means the delivery of health care services provided through the use of interactive audio, video, or other telecommunications or electronic technology by a health care provider at a hospital to a patient at a location other than at the hospital, or to a patient at the hospital where the provider is at a location other than the hospital, which enables the patient to interact with the health care provider at the time the health care services are provided. B. A service at the hospital is: (1) Presumed to be an outpatient service; and (2) Subject to rate regulation. C. In accordance with Health-General Article, §19-201, Annotated Code of Maryland, the Commission’s rate-setting jurisdiction extends to outpatient services provided at the hospital. Outpatient services associated with the federal 340B Program under the federal Public Health Service Act provided in a department of a regulated hospital that, on or before June 1, 2015, is under a merged asset hospital system, and which are physically located at another regulated hospital under the same merged asset hospital system, shall be subject to the rate-setting jurisdiction of the Commission. The Commission may begin setting rates for these services in anticipation of the hospital’s obtaining provider-based status for purposes of the 340B Program. D. A hospital that desires an exception to the presumption stated under §C of this regulation must receive a determination under the provisions of this regulation. E. Commission Approval. (1) A hospital may not charge a Commission-approved rate for an outpatient service without prior Commission or Commission staff approval. (2) A hospital may not open a new outpatient service, relocate an existing outpatient service, or convert an existing outpatient service from regulated or unregulated status without a prior determination from the Commission’s staff as to whether the service is being provided at the hospital. A request for determination shall be made in writing at least 60 days before the contemplated action. F. Upon request for an exception under §D of this regulation, the Commission's staff shall: (1) Review the information presented; (2) Consult with appropriate parties; (3) Visit the site of the service as it considers necessary; and (4) Notify the hospital of its determination as soon as practicable. G. In deciding whether an outpatient service is at the hospital, the Commission staff may consider, among other things, the following criteria: (1) Location of the entrances; (2) Location and signage of parking; (3) Location and language of signage at entrances, within buildings, on the campus, and in parking areas effectively alerting the public that a given building or service is either at the hospital or not at the hospital; (4) Location of registration, changing, and waiting areas; (5) Whether billing reflects clearly that the service is rate regulated or not rate regulated; (6) Whether any physical connection from an unregulated facility to the hospital, such as tunnels, hallways, covered walkways, elevators, or connecting bridges, will be restricted to hospital staff and physician use in order to ensure that patients and visitors do not have access to the unregulated facility from the hospital; (7) Whether there is any duplication of an unregulated service within the hospital in order to avoid inappropriate patient steering; (8) Whether there is any inappropriate mixing of regulated and unregulated services in the same building, which would tend to have the effect of confusing patients about the regulated or nonregulated status of a given service being provided; and (9) Whether any Medicare Part B physician's service being provided in an unregulated building also includes components of a Medicare Part A hospital service that would be reasonably expected by a patient to fall under Commission rate-setting jurisdiction. H. Based on consideration of the criteria stated in §G of this regulation, the Commission's staff shall make its determination on the request made under §E of this regulation. I. A hospital that fails to obtain or violates a staff determination on the hospital status of a given service may be subject to fines for inaccurate reporting under COMAR 10.37.01.03R and paybacks for inappropriate charges made during the time a staff determination on an outpatient service was not obtained or adhered to. J. A request for a determination under this regulation is not a contested case under the Administrative Procedure Act. K. A hospital may not bill a separate hospital facility fee when a health care provider who provided telehealth services is authorized to bill independently for the professional services rendered. L. The delivery of telehealth services as described in §A(2) of this regulation constitutes outpatient services provided at the hospital. #### Regulation .07-2 Outpatient Services — Freestanding Medical Facility. *COMAR 10.37.10.07-2* A. Definition. In this regulation, “freestanding medical facility” means a freestanding medical facility licensed under Health-General Article, Title 19, Subtitle 3A, Annotated Code of Maryland. B. The following outpatient services provided at a freestanding medical facility are considered hospital services under Health-General Article, §19-201, Annotated Code of Maryland: (1) Emergency Services; (2) Observation Services; and (3) Associated Ancillary Services, such as laboratory, radiology, imaging, EKG, and Medical/Surgical Supplies and Drugs. C. In accordance with Health-General Article, §19-201, Annotated Code of Maryland, the Commission’s rate-setting jurisdiction extends to those outpatient services provided at a freestanding medical facility, as designated by the Commission. D. A freestanding medical facility or a proposed freestanding medical facility that desires to provide a service not designated in §B of this regulation (an undesignated service) must receive a determination under the provisions of this regulation. E. Commission Approval. (1) A freestanding medical facility may not charge a Commission-approved rate for an undesignated service without prior Commission staff approval. (2) A freestanding medical facility may not open a new outpatient service, relocate an existing outpatient service, or convert an existing outpatient service from regulated or unregulated status without a prior determination from the Commission’s staff as to whether the service constitutes a hospital service subject to Commission rate regulation. A request for determination shall be made in writing at least 60 days before the contemplated action. F. Upon request for a determination, the Commission’s staff shall: (1) Review the information presented; (2) Consult with appropriate parties; (3) Visit the site of the service as it considers necessary; and (4) Notify the freestanding medical facility of its determination as soon as practicable. G. In deciding whether the service constitutes a hospital service subject to Commission rate regulation, Commission staff shall consider, among other things, the following criteria: (1) Cost of the service; (2) In consultation with Maryland Health Care Commission (MHCC) staff, access to and need for the service in the community; (3) Feasibility of providing the outpatient service in the community on an unregulated basis; and (4) Impact of the service on the All-Payer Model including, but not limited to, the Total Cost of Care limitations as prescribed in the All-Payer Model Agreement with the Center for Medicare and Medicaid Innovation. H. Based on the consideration of the criteria stated in §G of this regulation, the Commission staff shall make its determination on the request made under §E of this regulation within a reasonable period of time, taking into account, among other things, whether either a Certificate of Need application to establish a freestanding medical facility or a request for exemption from Certificate of Need to convert a licensed general hospital to a freestanding medical facility is pending before the MHCC and, if so, the time frame for staff to comment to MHCC on the financial feasibility of the proposed project. I. A freestanding medical facility that fails to obtain, or violates, a staff determination on the regulated status of a given service may be subject to fines for inaccurate reporting under COMAR 10.37.01.03R and paybacks for inappropriate charges made during the time a staff determination on an outpatient service was not obtained or adhered to. #### Regulation .08 Content. *COMAR 10.37.10.08* Each rate application shall include a list of services for which new rates are being requested, a list of the present and requested rates, and shall be based on the currently filed or required rate review system. #### Regulation .09 Method of Filing. *COMAR 10.37.10.09* The application may be filed by private messenger at the Offices of the Commission, or may be filed by registered mail, return receipt requested, at the following address: Health Services Cost Review Commission 4160 Patterson Avenue Baltimore, Maryland 21215 #### Regulation .10 Docketing and Receipt. *COMAR 10.37.10.10* A. Docketing. (1) When a valid rate application is received, as per the above regulations, it shall be entered on the Commission docket and a file opened. (2) Each rate application shall be given an annual docket number and a consecutive page number in the docket. (3) Each rate application shall be given a consecutive file number. (4) A regular rate application file number shall be noted “R”. (5) The file number of an order authorizing Commission investigation and review of established rates shall be noted “C”. (6) A temporary rate application file number shall be noted “I”. (7) An alternative method of rate determination application file number shall be noted “A”. (8) A rate application file number by a new hospital or a hospital with expanded facilities or new revenue centers shall be noted “N”. (9) The date of receipt of the rate application shall be noted on the docket and on the file. B. Upon request of the hospital, the Commission shall give the hospital a receipt for the rate application filing, showing the docket, page, and file numbers, and the date of receiving the rate application. C. The hospital shall file an original and three copies of each rate application and its supporting documents, if any. The Commission may prescribe the format to be used in the submission of rate applications and their supporting documents. In addition, the hospital shall file with each rate application a certificate of service indicating that the application and supporting documents have been mailed or served upon all designated parties to that proceeding and upon the Commission at its offices. #### Regulation .11 Recommendations of the Commission's Staff to the Commission, Options for Commission Review. *COMAR 10.37.10.11* A. A rate application review shall be completed and the recommendation given to the Commission as soon as possible. B. The recommendation shall include a specification of those areas of costs which the staff believes should be reviewed. When practicable, the recommendation shall also include the amounts challenged by the staff. C. Any of four actions may be recommended to the Commission. If two or more actions are recommended, the issues and rates to be evaluated in each action shall be set forth clearly. These four actions are as follows: (1) The Commission should hold a public hearing on rates; (2) The Commission should grant tentative approval or modify all or some of the rates and publish notice of an order nisi; (3) The Commission should hold a general hearing on rates; (4) The Commission should deny the application in which case it shall state the grounds for the denial. D. A copy of the recommendation shall be placed in the file and a copy shall be forwarded to each Commission member, the hospital, and each interested party. E. The Commission may not call for the effective date of an Order Nisi or call for a public hearing for 30 days after the Commission acts on the staff's recommendation. F. Before a staff recommendation or public hearing, the staff may hold conferences with hospital representatives and interested parties in an attempt to clarify or resolve potential issues. G. The Commission may prescribe a process for its consideration of a full rate application, which allows for written submissions in support of an application in lieu of an evidentiary hearing. A hospital that chooses this process for a Commission decision on its full rate application shall be afforded the right to submit to the Commission rebuttal information following any written response to the full rate application filed by Commission staff or designated interested parties. A hospital that chooses this written submission process waives its right to an evidentiary hearing. A hospital that chooses this written submission process does not waive its right to judicial review of a final Commission decision under the Administrative Procedure Act. As an additional alternative to an evidentiary hearing, a hospital may choose to enter into a binding arbitration process as prescribed by the Commission. #### Regulation .12 Preliminary Commission Order. *COMAR 10.37.10.12* A. The Commission shall consider the staff recommendation and, within 20 days of the date of the recommendation, issue its preliminary order adopting or modifying the recommendation, or referring the recommendations back to the staff for further review and subsequent recommendations. B. Order Nisi. (1) If the Commission issues a preliminary order granting tentative approval of any rates, it shall publish notice of the order nisi and the rates. (2) In addition, the Commission shall forward copies of the order nisi and the rates to the hospital and interested parties. (3) The order nisi shall state: (a) The name and address of the hospital; the names of the designated interested parties; the docket, page, and file numbers of the rate application proceeding and the date the application was filed with the Commission. (b) An enumeration of services and the proposed representative rates to be charged: (c) That the Commission has approved the rates as of a date to be specified, with a provision that the order may be suspended if reasonable cause is shown within 15 days of the date of the Order Nisi. (d) That objections to the tentatively approved rates shall be submitted (in person or by mail) to the Commission in writing; that designated interested parties shall submit copies of their objections, identifying the proceeding and Order Nisi to which objections are made to the hospital, and nine copies to the Commission office; and (e) That the file, which may contain supporting documents from the hospital, the Commission staff recommendation, the Accounting and Reporting reports and the Rate Review System of the hospital, is available at the Commission offices during regular business hours for public inspection. C. If the Commission issues an order for a public hearing, it shall forward copies of the order and public notice of the hearing to the hospital and the designated interested parties and shall publish a public notice of the hearing. The notice shall state: (1) The name and address of the hospital: the names of the designated interested parties; the docket, page, and file numbers of the rate application proceeding; the date the application was filed with the Commission; and the time, date, and place of the hearing; (2) A description of the issues to be presented at the public hearing; (3) That any person interested in the matter may attend the public hearing; (4) That all persons wishing to present relevant testimony or a statement at the public hearing shall forward copies to the hospital, each designated interested party, and nine copies to the Commission office; that the hospital and members of the public shall forward their testimony at least 8 days before the hearing; that the designated interested parties shall forward their testimony at any time before the close of the first session. D. Written testimony will not be considered unless the person submitting the testimony makes himself available for cross-examination unless stipulated to the contrary. E. If the Commission issues an order for a general hearing by the Commission, it shall forward copies of the order and public notice of the hearing to the hospital and the designated interested parties and publish a public notice of the hearing. #### Regulation .13 Public Hearing Before the Commission. *COMAR 10.37.10.13* A. Testimony shall be in writing and may not be delivered orally, except as set forth in Regulation .14K, of this chapter. B. Presenting Direct Testimony. (1) Any person who wishes to present direct testimony at the public hearing shall forward copies to the hospital and to every designated interested party, and shall file nine copies at the Commission's office. (2) If the public hearing is the result of a hospital rate application pursuant to Regulation .03, of this chapter, the applicant shall file its testimony at least 20 days before the date of the hearing. The staff of the Commission and members of the public shall file their testimony at least 10 days before the date of the hearing. (3) If the public hearing is the result of a Commission-initiated review of the rates of a hospital pursuant to Regulation .04, of this chapter, the Commission staff shall file its testimony at least 20 days before the date of the hearing. The hospital and members of the public shall file their testimony at least 10 days before the date of the hearing. (4) The designated interested parties shall file their testimony before the close of the first hearing session. C. The written direct testimony shall set forth the conclusions of the person submitting it and the arguments and facts supporting these conclusions. This testimony shall specifically pertain to the issues set forth in the public notice. D. Written direct testimony shall be verified either by: (1) Appearing before an officer or other person authorized to administer an oath; or (2) Signing the documents containing the statements required to be under oath and including the following representation: I do solemnly declare and affirm under the penalties of perjury that the facts set forth in the foregoing testimony are true and correct to the best of my knowledge, information and belief. E. Copies of written direct testimony shall be forwarded by the person submitting them to the hospital and the designated interested parties. F. All written direct testimony shall pertain solely to the proposed rates and be relevant to that subject. The presiding officer shall separate irrelevant material from the remainder of the record and keep that material apart. Parts of the body of the written direct testimony judged irrelevant by the presiding officer shall be so marked and may not be considered by the Commission in its deliberations. G. Persons submitting written testimony shall make themselves available for cross-examination and may give redirect and rebuttal testimony, orally or in writing, as directed or permitted by the presiding officer. H. All testimony at public hearings shall be filed in a timely manner. Requests for hearing postponements shall be made at a reasonable time before the hearing. These requests will only be granted for valid reasons, at the discretion of the Commission. If a hospital requests a postponement of an initial hearing session after the staff has already submitted its testimony, the Commission may require the hospital to file its testimony within the time frame of the original hearing date. #### Regulation .14 Conduct of Public Hearing. *COMAR 10.37.10.14* A. The Chairman of the Commission shall preside at the public hearing, which may be called to order when the presiding officer is in attendance. If the Chairman is absent or has been disqualified, the Vice-chairman or another commissioner shall preside. B. The Commission may direct that a hearing officer preside at the public hearing. In this case, the hearing officer may exercise all powers given to a presiding commissioner in these regulations during all sessions of the public hearing. C. At the discretion of the Commission, the specific duties of the hearing officer may include the following: (1) Making all rulings as to evidence, testimony, and official notice; (2) Setting the order for the examination and cross-examination of witnesses; (3) Administering oaths and affirmations; (4) Preparing both written and oral summaries of cases heard; (5) Preparing a recommendation for the Commission consisting of a written report with findings of fact and conclusions of law. D. The presiding officer may adjourn a hearing to a specified time, date, and place. E. All public hearings shall be recorded and testimony shall be under oath. A transcript of the record of the hearing shall be placed in the file of the proceeding. If the hospital or any other party desires a copy of the transcript, that party shall make arrangements with the stenographer. F. All direct testimony shall be submitted in writing and in an issue-by-issue format. The hearing shall begin with the examination of the representative of the hospital and any witnesses which the hospital may desire to have testify in its behalf. Whenever practicable, the testimony of witnesses shall proceed on an issue-by-issue basis. G. The Commission's staff member assigned to the proceeding shall be the next witness to be examined on the issue in question. In a Commission initiated review, the staff member assigned to the proceeding shall be examined before the hospital witness. H. Representatives of the other interested parties who have submitted written testimony shall be examined in the order set by the presiding officer. I. The Commission may examine witnesses at any time during the course of the proceeding. Commission staff and representatives of the hospital and interested parties may also examine witnesses. J. All testimony and examination shall be relevant to the subject of the proposed rates. Redundant and irrelevant testimony and examination shall be prohibited or stricken by the presiding officer. In addition, all interested parties may move the Commission to strike redundant and irrelevant testimony. K. At the presiding officer's discretion, he may allow direct oral testimony if a person attending the hearing demonstrates good cause for not submitting the testimony in written form before the hearing. Witnesses giving direct oral testimony shall be subject to cross-examination in the same manner as other witnesses. Anyone denied an opportunity to testify may appeal in writing to the full Commission within 7 days from this denial. L. To preserve his rights on appeal or otherwise, it is not necessary for a party objecting to a Commission ruling or decision to state the grounds of his objection, unless specifically requested to do so by a member of the Commission. M. At the Commission's reasonable discretion, it may permit the filing of post hearing briefs by the hospital, the Commission staff member or any interested party. Those parties submitting briefs shall file copies within a reasonable time designated by the presiding officer to the hospital, the designated interested parties, the Commission office and to each Commission member. N. A Commission member shall remove himself from participation in a public hearing as a Commission member if he decides that a conflict of interest may appear to prejudice his evaluation of the issues considered at the public hearing. Challenges to a Commission member's participation in a public hearing as a Commission member shall be considered by the Commission, the decision made by a majority vote, excluding the member objected to. Challenges shall be made by motion, at least 7 days before the public hearing. O. Except as otherwise provided, all decisions required during the conduct of the public hearing shall be made by the presiding officer. #### Regulation .15 Decision and Opinions of the Commission. *COMAR 10.37.10.15* A. The decision and the opinions of the Commission shall be based solely on the testimony, examination, and evidence presented at the public hearing, on the briefs filed, if any, on the evidence incorporated into the record of the proceeding by reference, on information and data in the record of the proceeding, and on matters as to which the Commission has taken official notice, which matters shall be made known to the parties to the proceedings. B. The deliberations of the Commission may be held in private executive session. C. The decision shall be made by a majority of the Commission members attending all sessions of the public hearing, or having read the record of hearings they did not attend. D. The decision shall be in writing and shall be based on a written majority or unanimous opinion stating the reasons and grounds for the Commission's decision. If a majority of Commissioners who are to render the final decision have not heard the evidence, the decision, if adverse to a party to the proceeding other than the Commission itself, may not be made until a proposal for decision, including findings of fact and conclusions of law, has been served upon the parties, and an opportunity has been afforded to each party adversely affected to file exceptions and present argument to a majority of the Commissioners who are to render the decision, who shall personally consider the whole record or those portions of it as may be cited by the parties. E. At the discretion of a Commission member (or members) who agrees with the decision reached by the majority of the Commission, but who does not agree with the majority opinion, or any part of it, the Commission member (or members) may file a written concurring opinion. F. A commission member (or members) who does not agree with the decision or any part of it reached by the majority of the Commission may, at his discretion, file a written dissenting opinion. G. The Commission's decision and the opinion (or opinions) shall be filed promptly and the Commission's staff then shall forward copies of the Commission's decision and the opinion (or opinions) to the hospital, to the designated interested parties, and to those parties who submitted written direct testimony before the public hearing. H. The Commission shall then publish: (1) An order approving, modifying, or disapproving the rates under review in the proceeding: (2) A notice that copies of the Commission's decision and the opinion (or opinions) may be obtained by written request to the Commission offices; and (3) A notice that the record of the complete proceeding is open for public inspection at the Commission offices during regular business hours. #### Regulation .16 General Hearing Before the Commission. *COMAR 10.37.10.16* A. To obtain general information from the region and community in which a hospital is located, the Commission, at its discretion, may hold a general hearing during the course of any rate proceeding. B. A general hearing shall be supplementary to other methods of rate review and may not replace them. C. A general hearing shall be held in the region in which the hospital whose rates are being reviewed is located. D. The public notice of a general hearing may state: (1) The name and address of the hospital, the designated interested parties, the docket, page, and file numbers of the application, and the time, date, and place of the hearing; (2) A description of the issues to be considered at the general hearing; (3) That any party interested in the matter may attend and present written or oral statements concerning the announced issues; and (4) That presentations may be limited as to time and that the number of spokespersons representing any group or organization may be limited. E. The general hearing shall be conducted by a hearing officer, any member of the Commission, a senior member of the Commission staff or its legal counsel. F. Persons attending the general hearing may present written or oral statements concerning the issues and rates set forth in the notice, which statements need not be verified. The presiding officer, within his discretion, may limit the number of spokespersons representing a group or organization and may limit the time allowed for oral statements. G. The conduct of the general hearing shall be recorded and the transcript shall be placed in the file of the proceedings. Any person may purchase a transcript of the hearing from the stenographer. H. The presiding officer may ask questions of the spokespersons. Within the discretion of the presiding officer, examination or questions of the spokespersons by other persons may be permitted. I. A transcript of the oral statements and copies of the written statements shall be placed in the Commission's file of the particular rate review proceeding. #### Regulation .17 Forms. *COMAR 10.37.10.17* The following forms are illustrative of pleadings and papers commonly used by parties in rate review proceedings and should be used wherever possible and, if necessary, adapted to the facts in the proceeding and the needs of the party using the forms: A. Rate Application. B. Public Notice of Rate Proceeding. C. Notice of Public Hearing. D. Notice of General Hearing: E. Notice of Orders Nisi. F. Order Nisi. G. Orders. H. Motions. I. Service. ________________________________________________________________________________________________________ (Signature of party filing pleading) J. Subpoena Duces Tecum for Rate Review. __________ (date) ________________________________________________________________________________________ Health Services Cost Review Commission K. Summons for Rate Review. __________ (date) ________________________________________________________________________________________ Health Services Cost Review Commission L. Summons for Hearing. __________ (date) ________________________________________________________________________________ Health Services Cost Review Commission M. Subpoena Duces Tecum for Hearing. __________ (date) ________________________________________________________________________________________ Health Services Cost Review Commission #### Regulation .18 Format. *COMAR 10.37.10.18* A. All pleadings, motions, and other papers filed in a Commission proceeding shall be typed or legibly written on sheets of bond paper not more than 11 inches long or 8-1/2 inches wide, and each paper shall have a left margin of at least 1 inch and a top margin of at least 1-1/2 inches. B. All pleadings, motions, and other papers, excluding exhibits appended to the pleadings, shall contain a heading at the top of the first page and, excluding appended exhibits and written direct testimony for a public hearing, a certificate of service at the bottom of the last page. #### Regulation .19 Filing of a Rate Application. *COMAR 10.37.10.19* A. A rate application filed by private messenger at the offices of the Commission shall be deemed to be filed on the date the application is received during normal working hours in the Commission's office. B. A rate application sent by registered mail shall be deemed to be filed 3 days after the application is placed in the U.S. Postal Service, these days to exclude Saturdays, Sundays, and holidays on which mail is not delivered to the Commission. The rate application's file date shall be entered on the docket of the proceeding. #### Regulation .20 Service. *COMAR 10.37.10.20* An original and three copies of all other pleadings, documents, testimony, or motions to be considered by the Commission shall be filed at the office of the Commission during regular business hours. All pleadings, documents, testimony, or motions shall contain a certificate of service indicating that the pleading, document, testimony, or motion has been mailed or served upon all designated parties to that proceeding and upon the Commission at its offices. #### Regulation .21 Computations of Time Periods and Extensions. *COMAR 10.37.10.21* A. In computing any period of time prescribed by these regulations, by order of the Commission or by any applicable statute, the day of the action or default initiating the designated period of time not be included. The last day of the period so computed is to be included unless it is a day on which the office of the Commission is closed, in which event the period runs until the end of the next day on which the office of the Commission is open. When the period of time allowed is more than 5 days, intermediate Saturdays, Sundays, and legal holidays shall be considered in the same manner as other days, but if the period of time allowed is 5 days or less, intermediate Saturdays, Sundays, and legal holidays may be not counted in computing the period of time. B. At the discretion of the Executive Director or his designee and, upon reasonable cause being shown by the submitting party, a period of time to submit a document or perform any other act permitted or prescribed by these regulations may be extended for a reasonable period of time. #### Regulation .22 Motions. *COMAR 10.37.10.22* A. Motions shall be in writing, except when made at a hearing or conference and shall state concisely the question which the Commission is called upon to determine, or the action the movant desires the Commission to take. It shall state all reasons, authorities, and citations in the body of the motion or in a supporting memorandum. A certificate of service, setting forth all parties upon whom a copy of the motion was served, shall be attached to the motion. B. The following actions shall be taken by motion: (1) Objections to actions of the Commission, or the Commission's staff; motions for clarification or reconsideration may not stay the orders of the Commission; (2) Demands for actions which the movant desires the Commission, or the Commission's staff to take; (3) Showing reasonable cause why an Order Nisi should not become effective; (4) Presenting a proper and justifiable question to the Commission; (5) Objections to the introduction of statements or other evidence by another party during a proceeding; (6) Challenges to members of the Commission; (7) Proposals for stipulations; (8) Answers to prior motions; and (9) All other actions which might be initiated properly or undertaken by a party to a proceeding and which are not otherwise provided for in these regulations. C. The motion shall be filed with the Commission and a copy shall be served on each affected party. D. A motion need not be verified unless it is based upon facts not apparent from the record or documents filed in the proceeding. E. Any affected party may answer an initial motion. F. The method of considering the motion, whether by executive communication, private hearing, or public hearing shall be determined by the chairman of the Commission. G. The Commission shall decide upon the question presented or action demanded in the motion in an equitable manner and as soon as practicable. H. Except when a motion is made at a conference or a hearing, the order granting or denying the motion shall be in writing and shall be entered on the record of the proceeding and copies of the order shall be served upon the moving party and all affected parties. I. The decision expressed in the order shall be decided pursuant to these regulations, if provision is made. If no provision is made, the motion shall be decided by a majority of the Commission. However, motions made in the course of a private conference or at a public hearing shall be decided by the presiding officer or a majority of the Commission attending the session of the conference or hearing at which the motion was made, as provided elsewhere in these regulations. Motions made in the course of a general hearing shall be decided by the hearing officer. #### Regulation .23 Subpoenas. *COMAR 10.37.10.23* A. At any time, the Commission may issue subpoenas directing a designated person to do the following: (1) Appear to testify at a hearing or private pre-hearing conference conducted by the Commission: (2) Appear at a specified time and date at the Commission offices or any designated place within the State, and, under oath or otherwise, give testimony and answer questions of the Commission or its authorized representatives; or (3) Produce documents, reports, or records of a particular activity for a specific period of time if he has custody of or access to the documents, reports, or records; the records may be in any reasonable form; the production shall be made at a specified time, date, and place. B. A subpoena shall be in whatever form is prescribed by the Commission and shall include: (1) The name, title, if any, and address of the person upon whom it is to be served and the address at which it is to be served; (2) The name(s), title(s), or position(s) of the witness(es) who shall appear and the time, date and place of their appearance. (3) A reasonable specification of the documents, reports and/or records, if any, to be produced at the designated time, date and place. C. Subpoenas shall be served at least 7 days before any public hearing or private or pre-hearing conference or executive session of the Commission at which the witness or witnesses are directed to appear, and shall be served at least 3 days before a private appointment. D. Subpoenas shall be served in person by a person designated by the executive director or, at his discretion, by registered or certified mail, return receipt requested. A signed return of the service or the return receipt shall be entered in the file and noted on the docket of the proceeding. E. A witness or a party with whom he is associated or affiliated may move to quash or modify the subpoena directed to him at any time before the date set for his appearance by filing with the Commission a motion to quash or modify the subpoena as provided in that section which pertains to motions in general. F. Failure to appear or to produce documents in accordance with a subpoena shall subject the witness or the party with which he is affiliated or associated to a finding of contempt by the Commission and other penalties provided by law or these regulations. #### Regulation .24 Effective Dates and Suspensions. *COMAR 10.37.10.24* A. The effective date of rates applied for in a rate application shall be 30 days from the date of the filing of the rate application with the Commission and shall be specified in the rate application. B. The Commission's staff may recommend the suspension of the effective date of the rates under review. C. At any time during a rate review, the Commission may order a suspension of the effective date of the rates under review, within the time specifications of Health-General Article, §19-219, Annotated Code of Maryland, and shall state the grounds for its action. #### Regulation .25 Evidence, Testimony, and Official Notice. *COMAR 10.37.10.25* A. The presiding officer at a public hearing or general hearing shall make all rulings as to evidence, testimony, and official notice and he may call on the legal counsel of the Commission for guidance in his rulings. B. All evidence and testimony shall be relevant and pertain solely to the issues being considered in a particular proceeding. C. Redundant evidence or testimony may not be permitted at public or general hearings or in the records of proceedings. D. Non-expert opinion testimony may be considered at a hearing and documentary opinion evidence may be entered in the record of a proceeding if the testimony or evidence is based on facts and matters admissible into evidence and the facts and matters are within the personal knowledge of the submitter of the document. E. Qualification as an expert shall be within the discretion of the presiding officer of the public or general hearing at which the proposed expert may proffer testimony or evidence or, if evidence is proffered at a time other than at a public hearing, within the discretion of the chairman of the Commission considering the proceeding. The expert qualification need not be based upon academic degrees or learning; reasonably extensive practical experience with the subject may be sufficient for an expert qualification. F. Subject to the provisions of these regulations, legal rules of evidence shall be followed as far as practicable at public and general hearings. G. Reliable and probative documents previously filed with or compiled by the Commission or its staff or consultants that are relevant to issues being considered by the Commission may be incorporated by reference into the record of a proceeding by the Commission or, by leave of the presiding officer, by a party to the proceeding. H. In the course of a proceeding, the Commission may take official notice of facts and matters in the same manner as the courts of the State take judicial notice of facts and matters and, additionally, may take notice, without meeting formal evidentiary rules, of general, technical, or scientific facts within the specialized knowledge of a member of the Commission. However, any party to the proceeding is entitled, on timely request, to an opportunity to show that the Commission should not take official notice of specific facts and matters or that the fact or matter to be officially noticed is inapplicable to the proceeding or is incorrect or misunderstood by the Commission. I. In reviewing a hospital's rate structure, the Commission may consider or take official notice of any public document, including, but not limited to, any filing made with the Maryland Health Resources Planning Commission relative to a Certificate of Need application including all projections of volumes, revenues, rates, and feasibility studies, as well as any public document concerning the financing of a project approved pursuant to a Certificate of Need. #### Regulation .26 Working Capital Differentials — Payment of Charges. *COMAR 10.37.10.26* A. Definitions. (1) In this regulation, the following terms have the meanings indicated. (2) Terms Defined. (a) “Debt collector” has the meaning stated in COMAR 10.37.13.01. (b) “Hospital” means a “facility” as defined in Health-General Article, §19- 301, Annotated Code of Maryland. (c) “Income-based payment plan” means a payment plan based on the patient’s household income as set forth in COMAR 10.37.13.05. (d) “Payment plan” has the meaning stated in COMAR 10.37.13.01. B. A third-party payer may obtain a discount in rates established by the Commission if it provides current financing monies in accordance with the following terms. (1) A third-party payer that provides current financing equal to the average amount of outstanding charges for bills from the end of each regular billing period and for discharged patients shall be entitled to a 2-percent discount. For purposes of this regulation, a regular billing period shall be based on a 30-day billing cycle. The current financing provided in here corresponds to a third party's paying on discharge. (2) A third-party payer that provides current financing equal to the average amount of outstanding charges for discharged patients plus the average daily charges times the average length of stay, shall be entitled to a 2.25-percent discount. The current financing provided to hospitals corresponds to a third party's paying on admission. (3) Outstanding charges shall be calculated by an amount equal to the hospital’s current average daily payment by the payer, multiplied by the hospital’s and third party payer’s processing and payment time. The precise calculation shall be made in accordance with the guidelines specified by Commission staff. (4) Upon request from an applicant, the Commission may approve an alternative method of calculating current financing monies. (5) The third-party payer shall adjust the current financing advance to reflect Commission rate orders and changes in volume associated with the particular payer and hospital. This adjustment shall be made within 45 days of a rate order or at such other time as circumstances warrant. In the absence of a rate order, the adjustment shall be made at least annually. C. The third-party payer shall promptly provide the Commission with a verified record of the detailed calculation of the current financing and of each recalculated balance as adjustments are made. The detailed calculations shall become a part of the public record. The Commission may, at any time, evaluate the amount of current financing monies provided to a hospital to assure that it meets the discount of requirements specified in §B of this regulation. If the Commission finds that the amount of current financing is inconsistent with the requirements of §B of this regulation, the Commission may, at its sole discretion, require an adjustment to the working capital advance or to the discount. D. Discounts. (1) A payer or self-paying patient, who does not provide current financing under §B of this regulation, shall receive a 2-percent discount if payment is made at the earlier of the end of each regular billing period or upon discharge from the hospital. (2) Payment within 30 days of the earlier of the end of each regular billing period or discharge entitles a payer or self-pay patient to a 1-percent discount. (3) For those payers not subject to Insurance Article, §15-1005, Annotated Code of Maryland, after 60 days from the date of the earlier of the end of each regular billing period or discharge, interest or late payment charges may accrue on any unpaid charges at a simple rate of 1 percent per month. (4) The interest or late payment charges may be added to the charge on the 61st day after the date of the earlier of the end of each regular billing period or discharge and every 30 days after that. (5) For patients that have entered into a hospital income-based payment plan under COMAR 10.37.13.05, the interest rate shall be established in accordance with the Guidelines set forth in COMAR 10.37.13.05. E. Hospital Billing Responsibilities. (1) A patient shall be given a bill for services at the earlier of the end of each regular billing period or upon discharge or dismissal, when dismissal for outpatients is analogous to discharge for inpatients. (2) This bill shall cover substantially all care rendered and should, except for some last day ancillary services and excepting arithmetic errors, represent the full charge for the patient's care. (3) A notice shall be posted prominently at the billing office of the hospital clearly notifying all patients of the availability of the discounts referred to in §D of this regulation. (4) The bill and the notice shall state that the patient shall receive a 2-percent discount by paying upon discharge or a 1-percent discount by paying within 30 days of discharge. F. GME Discounts. In those instances where a teaching hospital is reimbursed separately for the costs associated with the provision of graduate medical education (GME), the Commission shall calculate the percentage of the hospital's rates that these GME payments represent and provide notice of the amounts that may be credited toward the payment for services rendered. At all times, total payment received by the teaching hospital shall be in accordance with Commission-approved rates. #### Regulation .26-1 Maryland Health Insurance Plan (MHIP) Assessment. *COMAR 10.37.10.26-1* A. The Commission shall determine and assess those funds necessary to operate and administer the MHIP. The Commission shall adjust hospital rates to implement the revenue neutral assessment. B. The Commission shall assess each hospital up to 1 percent of its net patient revenue to operate and administer the MHIP. There shall be no MHIP assessment for Fiscal Year 2016. C. Beginning on September 5, 2003, each hospital whose rates have been approved by the Commission shall remit monthly, by the 5th of each month, 1/12 of its total share of the annual funding assessment determined by the Commission to be owed by the hospital to the Maryland Health Insurance Plan Fund as established under Insurance Article, Title 14, Subtitle 5, Annotated Code of Maryland. D. A hospital that fails to remit its funding assessment due in a timely manner may be subject to an annualized interest charge of 3 percentage points above the most recent average prime rate of interest, as published in the “Money Rates” section of The Wall Street Journal, on the unpaid balance. In addition, the Commission may impose penalties of up to 5 percent of the amount of any underpayment made by the hospital. #### Regulation .26-2 Assessment for Savings in Averted Uncompensated Care. *COMAR 10.37.10.26-2* A. Beginning July 1, 2008, the Commission shall assess annually a uniform, broad-based, and reasonable amount in hospital rates to reflect the aggregate reduction in hospital uncompensated care resulting from the expansion of health care coverage under Ch. 7, Acts of 2007 Special Session. B. Given the prospective nature of the rate system, the Commission shall ensure that the assessment amount does not exceed the savings projected in averted hospital uncompensated care from the health care coverage expansion. The Commission shall notify hospitals annually of the amount to be assessed by July 1 of each year, to be effective July 1. C. Beginning September 2008, on or before the 5th business day of each month, each hospital assessed in accordance with Health-General Article §19-214, Annotated Code of Maryland, and the provisions of this regulation shall make payment into the Health Care Coverage Fund established under Health-General Article, §15-701, Annotated Code of Maryland. D. A hospital that fails to remit its monthly funding assessment in a timely manner may be subject to an annualized interest charge of 3 percent the most recent average prime rate of interest, as published in the “Money Rates” section of the Wall Street Journal, on the unpaid balance. In addition, the Commission may impose penalties of up to 5 percent of the amount of any underpayment made by the hospital. #### Regulation .27 Designated Interested Parties. *COMAR 10.37.10.27* A. Designated interested parties for a specific rate review proceeding may include: (1) Those community oriented groups which the Commission determines have a significant interest in the hospital and its rate application; (2) Those third-party payors or their representatives who have been designated by the Commission as interested parties for this proceeding; (3) The hospital whose rates are being reviewed; (4) Maryland Health and Higher Educational Facilities Authority for rate review proceedings concerning hospitals with capital financing through the Authority. (5) Group Hospitalization, Incorporated, for rate review proceedings concerning hospitals with which it has contractual relations; and (6) Legal Aid Bureau of Baltimore City. B. Designated interested parties for all rate applications are: (1) Provider Reimbursement Department of Blue Cross of Maryland, Inc.; (2) Medical Care Programs Administration of the Maryland Department of Health (Medicaid); (3) Division of Provider Reimbursement and Accounting Policy, Bureau of Health Insurance, Social Security Administration, Department of Health, Education and Welfare of the United States (Medicare); and (4) Health Insurance Association of America. #### Regulation .28 Right to Counsel. *COMAR 10.37.10.28* A hospital or any other party in a rate review proceeding may be represented by legal counsel at any or all times during the proceeding, but there is no requirement that parties have legal counsel. #### Regulation .29 Challenges. *COMAR 10.37.10.29* A. Any party to a proceeding may challenge the ability of any member of the Commission to consider the rates or issues in that proceeding. Excepting private conferences, this challenge shall be made during the proceeding before its first hearing. Challenges may not be permitted after the first hearing, except in extraordinary circumstances. B. A challenge shall be verified in writing, specifying the member of the Commission and shall set forth all its reasons. The challenge shall be filed with the Commission and entered upon the record of the proceeding. C. A copy of the challenge shall be forwarded to the challenged member immediately after it is filed, and he may make whatever response he deems proper and necessary. D. The challenge shall be denied or allowed by a majority of the Commission, excluding the challenged member. The order based on the decision shall be filed with the Commission, entered in the record of the proceeding and served on the challenged member and the challenging party. E. If a challenge to a Commission member is allowed, he immediately shall cease all participation in the proceeding in question as a Commission member. F. The allowance of a challenge to a member of the Commission may not, in itself, disqualify him from serving as a Commission member in other matters and proceedings. #### Regulation .30 Consolidation. *COMAR 10.37.10.30* When two or more rate proceedings involve common questions of fact, the Commission, upon a majority vote of its members, may order that the common questions of fact be decided in a consolidated proceeding. #### Regulation .31 Burden of Proof. *COMAR 10.37.10.31* A. In proceedings initiated by a regular, temporary, or new hospital rate application, the burden of proof of the reasonableness, equity, and lack of undue discrimination of the proposed rates shall rest with the hospital. B. In proceedings initiated by an application for an alternative method of rate determination, the burden of proof of the applicability of the alternative method of rate review to the hospital shall rest with the hospital. C. In proceedings initiated by an order for Commission review of established rates, the burden of proof of the reasonableness, equity, and lack of undue discrimination of the established rates under review shall rest with the hospital. #### Regulation .32 Severability. *COMAR 10.37.10.32* If any section or provision of these regulations is declared unconstitutional or void by any court of competent jurisdiction, or its applicability to any person or circumstances is held invalid, the constitutionality or validity of the remainder of the regulations and the applicability to other persons and circumstances are not affected, and to this end, the sections and provisions of these regulations are declared to be severable. #### Regulation .33 Petition for Promulgation, Amendment, or Repeal of Regulation. *COMAR 10.37.10.33* A. Any interested party may file with the Commission a petition for the promulgation, amendment, or repeal of a regulation designed to implement, interpret, or prescribe law, policy, organization, procedure, or practice requirements of the Commission. The petition shall set forth: (1) The interest of the petitioner and the nature of the relief desired; (2) Any facts, views, arguments, and data deemed relevant by the petitioner; (3) Verification under oath by the party or by a duly authorized officer or agent of the party, whose address and title shall be stated. B. If the petition is for the promulgation of a regulation, a copy of the proposed regulation shall be attached. C. If the petition is for the amendment of a regulation, a copy of the amended regulation shall be attached with new matters underlined and matters to be deleted bracketed. D. In addition to and accompanying the original of the petition filed with the Commission, there shall be 12 copies for use of the Commission and other interested parties. E. The Commission shall consider the petition as well as all comments relating to it by interested parties. Within 30 days from the filing of the petition, the Commission shall render a decision: (1) Denying the petition and stating the reasons therefor; or (2) Submitting the proposed action to the Maryland Register for notice to, and comments by, all interested parties. #### Regulation .34 Petition for Declaratory Ruling. *COMAR 10.37.10.34* A. An interested person may file with the Commission a petition for a declaratory ruling with respect to the manner in which the Commission would apply a statute that the Commission enforces, a regulation of the Commission, or an order of the Commission, to a person or property on the facts set forth in the petition. B. The petition for a declaratory ruling shall be filed in writing and shall contain a statement describing in detail the interest of the petitioner in making the request, the issues involved, a statement of the facts, a listing of documents or statements, or both, to be considered, and a sworn statement by the petitioner that the facts contained there are true to the best of the person's knowledge and belief. C. Sixty days from the receipt of the petition the Commission shall inform the petitioner whether the petition will be granted. If the petition is not granted the Commission shall inform the petitioner in writing of the reasons for the denial. If the petition is granted, the Commission shall inform the petitioner when to expect the declaratory ruling. #### Regulation .35 Consideration and Disposition. *COMAR 10.37.10.35* A. Consideration. (1) The petition shall be granted whenever the Commission deems issuing a declaratory ruling advisable under the circumstances. (2) In rendering its declaratory ruling, the Commission: (a) Shall consider all the materials submitted with the petition; or (b) May, in its discretion: (i) Consult individuals or materials outside the corners of the petition; or (ii) Require argument of the question or permit the introduction of evidence. B. Disposition. (1) A declaratory ruling issued shall be in writing, stating the: (a) Issue; (b) Conclusion; (c) Facts upon which the conclusion was based; and (d) Sources relied upon. (2) A declaratory relief issued by the Commission shall plainly state on its face that it is a declaratory ruling pursuant to this regulation. (3) A written answer from the Commission to an inquiry may not be construed as a declaratory ruling unless made in conformity with these regulations. C. Publication and Inspection. The Commission: (1) Shall keep a record of each declaratory ruling issued and index all declaratory rulings issued by reference to statute or statutes or regulation or regulations involved. (2) May publish a declaratory ruling of general interest subject to the mandates of the Public Information Act, State Government Article, §10-601 et seq., Annotated Code of Maryland, and allow inspection of the declaratory rulings subject to the Public Information Act. D. Denial of a Petition for Declaratory Ruling. A petition may be denied if the: (1) Request contains incomplete information upon which to base an informed declaratory ruling; (2) Commission concludes that a declaratory ruling cannot reasonably be given on the matter; (3) Matter is adequately covered by a prior regulation, declaratory ruling, decision, or legal opinion; or (4) Commission concludes that a declaratory ruling would not be in the public interest. #### Regulation .36 Effect and Appeal. *COMAR 10.37.10.36* A. Effect. (1) A declaratory ruling shall be binding upon the Commission and the petitioner on the statement of facts covered in the declaratory ruling and set forth in the petition. (2) After notice and an opportunity to reply, a declaratory ruling may be reconsidered, amended, altered, or revoked by the Commission. B. Appeal. A declaratory ruling is subject to review as provided in State Government Article, §10-305, Annotated Code of Maryland. ### Chapter 11 — Rules of Procedure: Related Institutions **Authority:** Health-General Article, § 19-219, Annotated Code of Maryland **Administrative History:** Effective date: May 11, 1977 (4:10 Md. R. 768) #### Regulation .01 Definitions. *COMAR 10.37.11.01* “Commission” means the Health Services Cost Review Commission created by Chapter 627, Sec. 1, 1971 Laws of Maryland, and Health-General Article, § 19-202, Annotated Code of Maryland. #### Regulation .02 Report of Current and Prospective Charges. *COMAR 10.37.11.02* A. All related institutions shall immediately submit to the Commission a list of their current charges to patients. B. All related institutions shall immediately submit to the Commission their current interim Medicaid per diem rate, if any, and any supplementary charges to Medicaid patients. All changes shall be reported promptly to the Commission until the institution's Medicaid per diem rate is approved by the Commission. Final per diem rates shall be filed with the Commission during regular business hours. C. All information filed pursuant to Sec. A and B, above shall be open to public inspection and shall be available for examination at the offices of the Commission during regular business hours. D. Increases in the charges to be applied to non-Medicaid patients to be admitted to the related institution shall be submitted to the Commission at least 30 days before their implementation. All information filed pursuant to this section shall be open to public inspection and shall be available for examination at the offices of the Commission during regular business hours. E. Beginning with the second year of the Commission rate-approval for Medicaid, increases in the charges to be applied to patients who have already been admitted to a related institution may not exceed the allowed percentage increase of Medicaid rates in that institution without Commission approval. F. Before the second year of Commission rate-approval for Medicaid, the rate of increase by related institutions may not exceed the Commission approved general inflation increase for Medicaid patients without Commission approval. The approved inflation increase in the Medicaid rate shall accumulate and may be adjusted by the Commission for cost changes unique to an individual related institution. G. Patients Once Admitted. (1) All charges to patients who have once been admitted to a related institution are subject to Sec. E and F, above. (2) Patients “once admitted” include: (a) Patients going from a related institution to a hospital and back to the related institution; (b) Patients leaving a related institution temporarily on a physician-approved leave and then returning to the related institution; (c) Anyone readmitted to the same institution within a 2-week time period. H. Patients who are for valid medical reasons transferred to a different level of care within a related institution may not be charged prospectively more than that which they could be charged if originally admitted to that new level. I. Sections E--H shall be effective only if Medicaid is paying Commission-approved rates in any related institution. ### Chapter 12 — Cross-Subsidization **Authority:** Health-General Article, §§19-207, 19-210, 19-212, and 19-216, Annotated Code of Maryland **Administrative History:** Effective date: January 2, 1983 (9:26 Md. R. 2572) **Administrative History:** Regulation .01 repealed and new Regulations .01 — .03 adopted effective **Administrative History:** February 17, 1992 (19:3 Md. R. 305) **Administrative History:** Regulation .01 amended effective June 7, 1993 (20:11 Md. R. 913); December 2, 1996 (23:24 Md. R. 1683) **Administrative History:** Regulation .02 amended effective June 7, 1993 (20:11 Md. R. 913); December 2, 1996 (23:24 Md. R. 1683) **Administrative History:** Regulation .02B amended effective March 10, 1997 (24:5 Md. R. 412); July 28, 1997 (24:15 Md. R. 1062); March 4, 2013 (40:4 Md. R. 347) **Administrative History:** Regulation .03A amended effective March 4, 2013 (40:4 Md. R. 347) **Administrative History:** Regulation .03B amended effective June 7, 1993 (20:11 Md. R. 913) #### Regulation .01 Definitions. *COMAR 10.37.12.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Cross-subsidization” means the practice of charging a purchaser or class of purchaser more than the cost of care for a service with the result that another purchaser or class of purchaser is charged less than the cost of care for the same service. (2) “Discount” means a reduction to Commission-approved rates. (3) “Fixed-price contract” means an agreement or contract, written or oral, that sets forth a preestablished price for the provision of hospital services, or for the provision of hospital services in combination with physician or other services, that differs from Commission-approved rates. (4) Related Entity. (a) “Related entity” means an entity that is entering into at-risk arrangements for hospital-provided services and which is either subject to the exercise of control or significant influence by the management or operating policies of a hospital or exercises control over the management or operating policies of a hospital. In either event, one of the entities is, or may be, prevented from fully pursuing its own separate interests by virtue of its relationship with the other entity. (b) Examples of “related entity” transactions include transactions between: (i) A parent and its subsidiaries; (ii) Subsidiaries of a common parent; (iii) An entity and trusts for the benefit of employees that are managed by or under the trusteeship of the entities' management; (iv) An entity and its principal owners, management, or members of their immediate families; (v) Affiliates (an entity that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control of another entity); (vi) An entity and a joint venture whose participants include the entity or a related entity; and (vii) Two entities, both of which are related, directly or indirectly, to a common entity. #### Regulation .02 Hospital Charges to Purchasers or Classes of Purchasers. *COMAR 10.37.12.02* A. In order to assure purchasers of health care hospital services that rates are set equitably among all purchasers of services without undue discrimination, a hospital may not intentionally or otherwise engage in cross-subsidization without approval by the Commission. A hospital may grant a discount only as provided for in COMAR 10.37.10.26. B. Without the prior approval of the Commission, neither a hospital, a related entity, nor any entity or person acting on behalf of or in concert with a hospital shall enter into a fixed-price contract, or knowingly participate in or receive the benefit of any arrangement, directly or indirectly, pertaining to the delivery of hospital services. A hospital that has knowledge of such an arrangement shall promptly notify the Commission in accordance with this section in order that the Commission may determine whether the arrangement constitutes an unapproved discount. In order to obtain prior approval of the Commission, the hospital shall file a written application in accordance with COMAR 10.37.10.06. The filing of this application constitutes the filing of a required report under Commission law and regulation. Failure to file an application before the date on which a fixed-price contract is entered into, or the hospital or related entity knowingly participates in or receives benefit of such an arrangement, may subject the organization or organizations to fines up to $1,000 per day for each day the arrangement exists without prior approval. C. Factors to Consider When Reviewing a Proposed Arrangement. (1) In reviewing a proposed arrangement under this regulation, the Commission shall consider the following factors: (a) Whether the hospital is charging Commission-approved rates and whether payment for hospital services provided is made on the basis of Commission-approved rates; (b) Whether any proposed deviation from Commission-approved rates is cost justified and does not result in any form of cross-subsidization; (c) Whether payment at Commission-approved rates is made by an entity not related to the hospital; (d) The term of the agreement and the termination provisions; (e) The items or services to be furnished under the proposed agreement, including but not limited to hospital services, and the methodology for computing the payment for these services; and (f) The proposed sources of funding for the arrangement, including the source of funds to cover any anticipated or unexpected losses under the arrangement. (2) An agreement may not be reviewed for reasonableness unless the agreement is reduced to writing and specifies in advance the items or services to be furnished as well as the fixed price or methodology used to compute payment. (3) The risk of substantial loss associated with any arrangement may not be borne by the hospital, either directly or indirectly. D. For a period beginning with the effective date of this regulation and for a period of 6 months after that, the Commission shall offer an amnesty period. Any hospital which brings to the Commission's attention within the 6-month amnesty period any arrangement to which it is, directly or indirectly, a party shall have any price or compliance penalties which might otherwise have been imposed against it in connection with the arrangement, as set forth in Regulation .03 of this chapter, waived. The waiver shall expire at the later of the end of the 6-month amnesty period or the consideration of the Commission of the approval of the arrangement. #### Regulation .03 Penalties. *COMAR 10.37.12.03* A. The Commission may impose penalties of up to $1,000 per day, which shall be instead of the $100 per day penalty for failing to file reports as set forth in COMAR 10.37.01.03N, for a required report submitted by a hospital that includes information which has the effect of violating Regulation .02 of this chapter. The report shall be considered substantially inaccurate and untimely filed. B. A hospital that violates the provisions of Regulation .02 of this chapter shall, in addition to any penalties imposed under §A of this regulation, be subject to the overcharge and undercharge penalties contained in COMAR 10.37.03.05, which shall be applied to the difference between what was actually charged by the hospital and what the hospital would have been required to charge under a valid Commission rate order based on accurate information filed. In addition, the Commission may revoke any discount previously granted under COMAR 10.37.10.26 to a third party that participates in an arrangement determined by the Commission to constitute an unapproved discount or otherwise violates the provisions of Regulation .02 of this chapter. ### Chapter 13 — Patient Rights and Obligations; Hospital Credit and Collection and Financial Assistance Policies **Authority:** Health-General Article, §§19-214.2, 19-214.3, 19-207, and 19-219, Annotated Code of Maryland **Administrative History:** Effective date: December 11, 2025 (52:24 Md. R. 1198) #### Regulation .01 Definitions. *COMAR 10.37.13.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Credit and collection policy” means a hospital’s policy on the collection of medical debt. (2) Debt Collector. (a) “Debt collector” means a person who engages directly or indirectly in the business of: (i) Collecting for, or soliciting from another, medical debt; (ii) Giving, selling, attempting to give or sell to another, or using, for collection of medical debt, a series or system of forms or letters that indicates directly or indirectly that a person other than the hospital is asserting the medical debt; or (iii) Employing the services of an individual or business to solicit or sell a collection system to be used for collection of medical debt. (b) “Debt collector” includes a “collection agency” as defined in Business Regulation Article, §7-101, Annotated Code of Maryland. (3) “Financial hardship” means medical debt, incurred by a family over a 12-month period, that exceeds 25 percent of family income. (4) “Hospital” has the meaning stated in Health-General Article, §19- 301(f), Annotated Code of Maryland. (5) Hospital Services. (a) “Hospital services” means: (i) Inpatient hospital services as enumerated in 42 C.F.R. §409.10, as amended; (ii) Emergency services, including services provided at a freestanding medical facility licensed under Health Occupations Article, Title 19, Subtitle 3A, Annotated Code of Maryland (iii) Outpatient services provided at a hospital as defined in COMAR 10.37.10.07-2; (iv) Outpatient services, as specified by the Commission in COMAR 10.37.10.07-2, provided at a freestanding medical facility licensed under Health-General Article, Title 19, Subtitle 3A, Health-General Article, Annotated Code of Maryland that has received a certificate of need under Health-General Article, §19–120(o)(1), Annotated Code of Maryland, or an exemption from obtaining a certificate of need under Health-General Article, §19–120(o)(3), Annotated Code of Maryland; and (v) Identified physician services for which a facility has Commission–approved rates on June 30, 1985. (b) “Hospital services” includes a hospital outpatient service: (i) Of a hospital that, on or before June 1, 2015, is under a merged asset hospital system; (ii) That is designated as a part of another hospital under the same merged asset hospital system to make it possible for the hospital outpatient service to participate in the 340B Program under the federal Public Health Service Act; and (iii) That complies with all federal requirements for the 340B Program and applicable provisions of 42 C.F.R. §413.65. (c) “Hospital services” does not include: (i) Outpatient renal dialysis services; (ii) Outpatient services provided at a limited service hospital as defined in Health-General Article, §19–301, Annotated Code of Maryland except for emergency services; or (iii) Physician services that are billed separately. (6) Household. (a) “Household” means, at a minimum, for an adult patient, the patient and the following individuals that live in the same dwelling: (i) A spouse, regardless of whether the patient and spouse expect to file a joint federal or State tax return; (ii) Biological children, adopted children, or stepchildren; and (iii) All individuals on the same federal or State tax return, including anyone for whom the patient claims a personal exemption in a federal or State tax return. (b) “Household” means, at a minimum, for a patient who is a child, the patient and the following individuals that live in the same dwelling: (i) Biological parents, adoptive parents, stepparents, or guardians; (ii) Biological siblings, adopted siblings, or step siblings; and (iii) All individuals on the same federal or State tax return, including anyone for whom the patient’s parents or guardians claim a personal exemption in a federal or State tax return. (c) The terms "household” and “family” are synonymous for the purposes of this chapter. (7) Income. (a) “Income” means total taxable income, before taxes. (b) “Income” includes: (i) If a hospital uses state or federal tax returns to verify income, the adjustments listed on Schedule 1 of Form 1040; and (ii) If a hospital utilizes an asset test, the value of household monetary assets, consistent with Regulation 06J of this chapter. (8) “Initial bill” means the first billing statement provided to an individual by a hospital after the care, whether inpatient or outpatient, is provided and the individual has left the hospital. (9) “Medical debt” means out-of-pocket expenses, including co-payments, coinsurance, and deductibles, for hospital services that are regulated by the Commission that are billed to a patient or a co-signer for the patient, excluding amounts contractually paid by another payer such as insurers, including Medicare, Medicaid, or CHIP. (10) “Medically necessary care” including care provided in accordance with the Emergency Medical Treatment and Labor Act of 1986), means care that is: (a) Directly related to diagnostic, preventative, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability or health condition; (b) Consistent with current accepted standards of good medical practice; and (c) Not primarily for the convenience of the patient, the patient’s family, or the provider. (11) Monetary Assets. (a) “Monetary assets” means assets in excess of $100,000 that can readily be converted into a fixed or precisely determinable amount of money, including cash and cash equivalents. (b) “Monetary assets” include cash on hand, bank deposits, investment accounts, accounts receivable, and notes receivable. (c) “Monetary assets” do not include retirement assets to which the Internal Revenue Service has granted preferential tax treatment, including deferred–compensation plans qualified under the Internal Revenue Code or nonqualified deferred–compensation plans. (12) Payment Plan. (a) “Payment plan” means an agreement between a patient, or a guarantor, to pay for a hospital service over a period of time. (b) “Payment plan” includes: (i) An “income-based payment plan” set forth in Regulation .05 of this chapter; and (ii) A “non-income-based payment plan” set forth in Regulation .05W of this chapter. (13) “Qualified Maryland resident” means someone who lives in Maryland for more than 6 months of the year or whose primary residence is in Maryland, including those in Maryland for school or work. (14) Written. (a) “Written” means communications in paper form and communications delivered electronically, including through electronic mail, a secure web, or mobile based application such as a patient portal. (b) “Written” does not include oral communications, including communications delivered by phone. #### Regulation .02 Electronic Delivery of Written Communications. *COMAR 10.37.13.02* A. A patient may opt out of receiving written communications required by Regulations .03—.08 of this chapter through electronic delivery methods, such as through email or a patient portal. B. A hospital or debt collector who communicates with a patient electronically must include in such communication, or attempt to communicate, a clear and conspicuous statement describing a reasonable and simple method by which the patient can opt out of further electronic communications by the hospital or debt collector. C. A hospital or debt collector may not require, directly or indirectly, that the patient, in order to opt out of electronic communication, pay any fee or provide any information other than: (1) The patient’s opt out preferences; and (2) The email address, telephone number for text messages, or other electronic-medium address subject to the opt-out request. D. If a hospital or debt collector receives notice from a patient that the patient is opting out of receiving written communications through electronic delivery methods, the hospital or the debt collector: (1) May not provide the written communications required by Regulations .03—.08 of this chapter through electronic delivery methods; and (2) Shall deliver the written communications through non-electronic delivery methods. E. Notice of Patient Opting Out of Written Communications. (1) If a hospital receives notice from a patient that the patient is opting out of receiving written communications through electronic delivery methods, and the hospital uses a debt collector with respect to that patient, the hospital shall immediately inform the debt collector that the patient is opting out of electronic delivery methods. (2) If a debt collector receives notice from a patient that the patient is opting out of receiving written communications through electronic delivery methods, the debt collector shall immediately inform the hospital that controls that patient account that the patient is opting out of electronic delivery methods. #### Regulation .03 Hospital Information Sheet. *COMAR 10.37.13.03* A. Each hospital shall develop an information sheet that: (1) Describes clearly: (a) The hospital's financial assistance policy as required in Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland; and (b) A patient's legal rights and obligations with regard to hospital billing and collection; (2) Informs the patient, the patient’s family, the patient’s authorized representative, or the patient’s legal guardian: (a) That the hospital is permitted to bill outpatients a fee, commonly referred to as a facility fee, for their use of hospital facilities, clinics, supplies, and equipment, and nonphysician services, including but not limited to the services of nonphysician clinicians, in addition to physician fees billed for professional services provided in the hospital; (b) Of the patient’s right to request and receive a written estimate of the total charges for the hospital non-emergency services, procedures, and supplies that reasonably are expected to be provided and billed for by the hospital, in addition to the good faith estimate requirements in 42 U.S.C §2799B-6, the No Surprises Act; (c) Of the patient’s right to file a complaint with the Commission or jointly with the Health Education and Advocacy Unit of the Maryland Attorney General’s Office against a hospital for an alleged violation of Health-General Article, §§19-214.1 and 19-214.2, Annotated Code of Maryland; (d) Of the availability of an income-based payment plan; and (e) That physician charges, to both hospital inpatients and outpatients, are generally not included in the hospital bill and are billed separately; (3) Provides contact information for: (a) The individual or office at the hospital that is available to assist the patient, the patient's family, or the patient's authorized representative in order to understand: (i) The patient's hospital bill; (ii) The patient’s rights and obligations with regard to the hospital bill, including the patient’s rights and obligations with regard to reduced-cost medically necessary care due to a financial hardship; (iii) How to apply for financial assistance; (iv) How to apply for the Maryland Medical Assistance Program and any other programs that may help pay the bill; and (v) How to apply for a payment plan; (b) The Maryland Medical Assistance Program; (c) Filing a complaint with the Commission or jointly with the Health Education and Advocacy Unit of the Maryland Attorney General’s Office against a hospital for an alleged violation of Health-General Article, §§19-214.1 and 19-214.2, Annotated Code of Maryland; and (4) Includes a section that allows the patient to initial that the patient has been made aware of the financial assistance policy. B. The information sheet shall be written in: (1) Simplified language; (2) At least 12-point type; and (3) The patient’s preferred language or, if no preferred language is specified, each language spoken by a limited English proficient population that constitutes at least 5 percent of the overall population within the city or county in which the hospital is located as measured by the most recent census. C. The information sheet shall conform with Health-General Article, §19–342(d)(7) and (10), Annotated Code of Maryland. D. The information sheet shall be provided in writing to the patient, the patient’s family, the patient’s authorized representative, or the patient’s legal guardian: (1) Before the patient receives scheduled medical services; (2) Before discharge; (3) With the hospital bill; (4) On request; and (5) In each written communication to the patient regarding collection of the hospital bill. E. The hospital bill shall include a reference to the information sheet. F. The Commission shall: (1) Establish uniform requirements for the information sheet; and (2) Review each hospital's implementation of and compliance with the requirements of this regulation. #### Regulation .04 Hospital Credit and Collection Responsibilities. *COMAR 10.37.13.04* A. Each hospital shall submit to the Commission, at times prescribed by the Commission, the hospital's credit and collection policy. B. The policy shall: (1) Provide for active oversight by the hospital of any contract for collection of debts on behalf of the hospital; (2) Prohibit the hospital from selling any debt, except as permitted by Health-General Article, §19–214.2(m), Annotated Code of Maryland and §O of this regulation; (3) Prohibit the hospital from: (a) Engaging in collection activities on 100 percent of the outstanding amount of the Commission-set charge for debt sold under §O of this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland; and (b) Collecting on judgments entered into on patient debt that was sold under §O of this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland; (c) Reporting adverse information to a consumer reporting agency; (d) Filing a civil action to collect a debt against a patient within 240 days after the initial bill is provided; (e) Filing a civil action to collect a debt against a patient whose outstanding hospital medical debt is at or below $500; (f) Forcing the sale or foreclosure of a patient’s primary residence to collect medical debt; (g) Requesting a lien against a patient’s primary residence in an action to collect medical debt; (h) Requesting the issuance of or otherwise knowingly taking action that would cause a court to issue a body attachment against a patient or an arrest warrant against a patient, if the hospital files an action to collect medical debt; and (i) Requesting a writ of garnishment of wages or filing an action that would result in an attachment of wages against a patient to collect medical debt if the patient is eligible for free or reduced-cost medically necessary care, in accordance with Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland; (4) In accordance with Health-General Article, §19-214.2(c), Annotated Code of Maryland and §G of this regulation, provide for a refund of amounts collected from a patient or the guarantor of a patient who was later found to be eligible for free medically necessary care within 240 days after the initial bill was provided under Health General Article, §19-214.1, Annotated Code of Maryland and §G of this regulation; (5) If the hospital has obtained a judgment against or had reported adverse information to a consumer reporting agency about a patient who later was found to be eligible for free medically necessary care, in accordance with Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland, within 240 days after the initial bill was provided, require the hospital to seek to vacate the judgment or strike the adverse information; (6) Provide a mechanism for a patient to: (a) Request the hospital to reconsider the denial of free or reduced–cost care; and (b) File with the hospital a complaint against the hospital or a debt collector used by the hospital regarding the handling of the patient’s bill; (7) For a patient who is eligible for free or reduced cost-care under the hospital’s financial assistance policy, prohibit the hospital from: (a) Charging interest on the debt owed on a bill for the patient before a court judgement is obtained; or (b) Collecting fees or any other amount that exceeds the approved charge for the hospital service as established by the Commission; (8) Establish a process for making payment plans available to all patients in accordance with Regulation .05 of this chapter and Health-General Article, §19-214.2(e)(3), Annotated Code of Maryland; (9) Provide detailed procedures for the following actions: (a) When garnishments may be applied to a patient’s or patient guarantor’s income in accordance with §I of this regulation and Health-General Article, §19-214.2(f)(4), Annotated Code of Maryland; (b) When a lien on a patient’s or patient guarantor’s personal residence, excluding a primary resident in accordance with §I of this regulation and Health-General Article, §19-214.2(g)(2), Annotated Code of Maryland, or motor vehicle may be placed; (c) The hospital's procedures for collecting any medical debt, consistent this regulation; (d) The circumstances in which the hospital will seek a judgment against a patient for the patient’s medical debt, subject to §I of this regulation and Health-General Article, §19–214.2, Annotated Code of Maryland; (e) The consideration by the hospital of patient income, assets, and other criteria set forth in this regulation; and (10) Comply with Health-General Article, §24-2502, Annotated Code of Maryland. C. Consistent with Health-General Article, §19-214.2(e)(5), Annotated Code of Maryland, a hospital shall demonstrate that it attempted in good faith to meet the requirements of Health-General Article, §19-214.2(e), Annotated Code of Maryland, and the Guidelines set forth in Regulation .05 of this chapter before the hospital: (1) Files an action to collect the patient’s medical debt; or (2) Delegates collection activity to a debt collector for a patient’s medical debt. D. The hospital shall be deemed to have demonstrated that it attempted to act in good faith under Health-General Article, §19-214.2(e)(5)(i)(2), Annotated Code of Maryland and §C(2) of this regulation if, before delegating collection of a patient’s medical debt to a debt collector, the hospital: (1) Provides the information sheet before the patient receives scheduled medical services and before discharge in accordance with Health-General Article, §19-214.2(e)(1) and (2), Annotated Code of Maryland, and in Regulation .03D(1) and (2) of this chapter; and (2) Establishes a process for making payment plans available to all patients in accordance with Health-General Article, §19-214.2(e)(3), Annotated Code of Maryland and Regulation .05 of this chapter. E. In delegating any or all collection to a debt collector for a patient’s medical debt, the hospital may rely on a debt collector to engage in various activities, including: (1) Facilitating and servicing payment plans in accordance with the Guidelines, including receiving and forwarding any payments received under a payment plan approved by the hospital; and (2) Such other activities as the hospital may direct in collecting and forwarding payments under a payment plan. F. A hospital may not seek legal action to collect a patient’s medical debt until the hospital has established and implemented a payment plan policy that complies with the Guidelines. G. As provided by Health-General Article, §19-214.2(c), Annotated Code of Maryland: (1) A hospital shall provide: (a) For a refund of amounts exceeding $25 collected from a patient or the guarantor of a patient who was found to be eligible for free medically necessary care within 240 days after the initial bill is provided to the patient; and (b) The refund to the patient not later than 30 days after determining that the patient was eligible for free medically necessary care. (2) If a patient is enrolled in a means-tested government health care plan that requires the patient to pay out-of-pocket for hospital service, a hospital shall have a refund policy that complies with the terms of the patient’s plan. H. Consumer Reporting. (1) A hospital may not commence civil action against a patient for nonpayment or delegate collection activity to a debt collector, if the hospital: (a) Was notified in accordance with federal law by the patient or the insurance carrier that an appeal or a review of a health insurance decision is pending within the immediately preceding 60 days; (b) Is processing a requested reconsideration of the denial of free or reduced-cost medically necessary care under Regulation .06A(1)(c)(v) of this chapter and Health-General Article, §19-214.1(b)(2)(iv), Annotated Code of Maryland, that was appropriately completed by the patient or has completed the reconsideration within the immediately preceding 60 days; or (c) Sold the debt under §O of this regulation and Health-General Article, §19-214.2(m). (2) A hospital shall comply with Health-General Article, §24-2502, Annotated Code of Maryland. (3) A hospital shall report the fulfillment of a patient’s payment obligation within 60 days after the obligation is fulfilled to any consumer reporting agency to which the hospital had reported adverse information about the patient, including if the debt was sold under §O of this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland. (4) Not later than November 1, 2025, a hospital that had reported adverse information about a patient to a consumer reporting agency shall instruct the consumer reporting agency to delete the adverse information about the patient. I. Civil Action. (1) Deceased Patients. (a) A hospital may not make a claim against the estate of a deceased patient to collect medical debt if the deceased patient was known by the hospital to be eligible for free medically necessary care, in accordance with Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland, or if the value of the estate after tax obligations are fulfilled is less than half of the medical debt owed. (b) A hospital may offer the family of the deceased patient the ability to apply for financial assistance. (2) A hospital may not file an action to collect medical debt until the hospital determines whether the patient is eligible for free or reduced-cost medically necessary care under Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland. (3) At least 45 days before filing an action against a patient to collect medical debt, but not within 240 days after the initial bill is provided, a hospital shall send written notice of the intent to file an action to the patient. (4) The notice required in §I(3) of this regulation shall: (a) Be sent to the patient by certified mail and first class mail; (b) Be in simplified language; (c) Be in at least 12-point type; (d) Include: (i) The name and telephone number of the hospital, the debt collector, if applicable, and an agent of the hospital authorized to modify the terms of the payment plan, if any; (ii) The amount required to cure the nonpayment of medical debt, including past due payments, interest, penalties, and fees; (iii) A statement recommending that the patient seek debt counseling services; (iv) Telephone numbers and internet addresses of the Health Education Advocacy Unit of the Office of the Attorney General, available to assist patients experiencing medical debt; and (v) An explanation of the hospital's financial assistance policy; (e) Be provided in the patient’s preferred language or, if no preferred language is specified, English and each language spoken by a limited English proficient population that constitutes at least 5 percent of the population within the jurisdiction in which the hospital is located as measured by the most recent federal census; and (f) Be accompanied by: (i) An application for financial assistance under the hospital's financial assistance policy, along with instructions for completing the application for financial assistance, specific instructions about where to send the application, and the telephone number to call to confirm receipt of the application; (ii) Language explaining the availability of an income-based payment plan to satisfy the medical debt that is the subject of the hospital debt collection action; and (iii) The information sheet required under Regulation .03 of this chapter and Health-General Article, §19-214.1(f), Annotated Code of Maryland. J. Delegation of Collection to a Debt Collector. If a hospital delegates collection activity to a debt collector, the hospital shall: (1) Specify the collection activity to be performed by the debt collector through an explicit authorization or contract; (2) Require the debt collector to abide by the hospital’s credit and collection policy; (3) Specify procedures the debt collector must follow if a patient appears to qualify for financial assistance under Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland; and (4) Require the debt collector to: (a) In accordance with the hospital’s credit and collection policy, provide a mechanism for a patient to file with the hospital a complaint against the hospital or the debt collector regarding the handling of patient’s bill; (b) If a patient files a complaint with the debt collector, forward the complaint to the hospital; and (c) Along with the hospital, be jointly and severally responsible for meeting the requirements of this regulation, Regulation .06 of this chapter, and Health-General Article, §19-214.2, Annotated Code of Maryland. K. Consent to Assume Liability for Medical Debt. (1) A spouse or another individual may not be held liable for the medical debt of an individual 18 years old or older unless the individual voluntarily consents to assume liability for the patient’s medical debt. (2) The consent shall be: (a) Made on a separate document signed by the individual; (b) Not solicited in an emergency room or during an emergency situation; and (c) Not required as a condition of providing emergency or non-emergency health care services. L. The Board of Directors of each hospital shall review and approve the hospital’s financial assistance policy required under Regulation .06 of this chapter and Health-General Article, §19-214.1, Annotated Code of Maryland and debt collection policy required under Regulation .04 of this chapter and Health-General Article, §19-214.2, Annotated Code of Maryland at least every 2 years. A hospital may not alter its financial assistance or credit and collection policies without approval of the Board of Directors. M. The Commission shall review each hospital's implementation of and compliance with the hospital's policy and the requirements of §B of this regulation. N. Reporting Requirements. (1) Each hospital shall annually submit to the Commission within 120 days after the end of each hospital’s fiscal year a report including: (a) The total number of patients by race or ethnicity, gender, and zip code of residence against whom the hospital or a debt collector used by the hospital, filed an action to collect medical debt; (b) The total number of patients by race or ethnicity, gender, and zip code of residence with respect to whom the hospital has and has not reported or classified a bad debt; (c) The total dollar amount of charges for hospital services provided to patients but not collected by the hospital for patients covered by insurance, including the out-of-pocket costs for patients covered by insurance, and patients without insurance; and (d) For hospital debts owed by patients of the hospital that the hospital sold to a governmental unit, contractor, or nonprofit organization under Health-General Article, §19-214.2(m), Annotated Code of Maryland and §O of this regulation: (i) The total dollar amount of the debt sold by the hospital for the reporting year; (ii) The total dollar amount paid by the hospital to the unit, contractor, or nonprofit organization who purchased the debt; and (iii) The total number of patients whose debt was sold, in full or in part, to the unit, contractor, or nonprofit organization who purchased the debt. (2) The Commission shall post the information submitted under §N(1) of this regulation on its website. O. Selling Medical Debt. (1) Consistent with Health-General Article, §19-214.2(m), Annotated Code of Maryland, a hospital may sell debt owed to the hospital by a patient for hospital services to a governmental unit, an entity that is under contract with the governmental unit, or to a nonprofit organization that is exempt from taxation under 26 U.S.C. §501(c)(3) of the Internal Revenue Code for the sole purpose of canceling the debt. (2) The contract between the hospital and the governmental unit, entity that is under contract with the governmental unit, or nonprofit organization purchasing the debt shall state that the sole purpose of the sale of the debt is to cancel the debt. (3) The patient is not responsible to the hospital, the governmental unit, the entity that is under contract with the governmental unit, or the nonprofit organization for any amount of the debt that is sold, or any interest, fees, or costs associated with the debt or the sale. (4) Debt sold under this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland: (a) Must be for hospital services provided at least 2 years before the date of the sale; (b) May not be expected to yield additional reimbursements from a third-party payor; (c) May not be subject to an open appeal with an insurance company; and (d) Must be for an individual whose family income is at or below 500 percent of the federal poverty level or who has medical debt exceeding 5 percent of the patient’s family income, as determined by the governmental unit, contractor, or nonprofit organization purchasing the debt. (5) Debt sold under this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland, may be sold with a reduction of Commission charges. (6) The Commission shall treat the amount of payments to hospitals under this subsection as an offset to uncompensated care amounts reported by hospitals. (7) The purchaser of the debt shall: (a) Notify the patient that the debt has been canceled; and (b) If the hospital obtained a judgment against the patient or reported adverse information to a consumer reporting agency about the patient, seek to vacate the judgment or strike the adverse information. (8) If a hospital sells hospital medical debt under this regulation and Health-General Article, §19-214.2(m), Annotated Code of Maryland, the hospital must immediately dismiss actions pending against a patient for collection of that debt. #### Regulation .05 Guidelines for Hospital Payment Plans. *COMAR 10.37.13.05* A. Scope. (1) As described in this regulation, the Guidelines for Hospital Payment Plans apply to any income-based payment plan offered by a hospital to a patient to pay for medically necessary hospital services after the services are provided. (2) “Income” in this regulation means household monthly income. (3) Prepayment Plans. Nothing in the Guidelines prevents a hospital from offering patients arrangements to make payments prior to service, provided that: (a) A hospital may not require or steer a patient to enter into such an arrangement solely to avoid the application of these Guidelines; (b) Before a hospital requests pre-payment for a hospital service, the hospital shall: (i) Comply with the notice provisions of Health-General Article, §19-214.1, Annotated Code of Maryland, and Regulations .03 and .06 of this chapter; (ii) Advise the patient about the availability of financial assistance; (iii) Process any request for financial assistance; and (iv) Advise the patient about the availability of income-based payment plans, including information about the 5 percent cap on monthly payment amounts under §F(1) of this regulation; and (c) Such an arrangement terminates once the hospital service is rendered. (4) Unregulated Services. These Guidelines apply only to hospital services that are regulated by the Commission. These Guidelines do not apply to services that are not regulated by the Commission, including physician services. (5) Limitation of the Guidelines. These Guidelines do not prevent hospitals from extending payment plans for services, such as physician services, or at times that are outside the parameters of the Guidelines. Except as otherwise required by law or regulation, payment plans that are outside the parameters of these Guidelines are not subject to the Guidelines. B. Access to Income-Based Payment Plans. (1) Availability of Income-Based Payment Plans. Maryland hospitals shall make income-based payment plans available to all patients who are Maryland residents, including individuals temporarily residing in Maryland due to work or school, irrespective of their: (a) Insurance status; (b) Citizenship status; (c) Immigration status; or (d) Eligibility for reduced-cost medically necessary care, including reduced-cost medically necessary care due to financial hardship, under Regulation .06 of this chapter. (2) Treatment of Nonresidents and Unregulated Services. (a) These Guidelines do not prevent a hospital from extending payment plans to patients who are not described in §B(1) of this regulation. (b) These Guidelines do not prevent a hospital from extending payment plans to patients for services that are not regulated by the Commission. (c) Except as required by §U of this regulation or by other law or regulation, payment plans for patients which are not described in §B(1) of this regulation and payment plans for services that are not regulated by the Commission are not subject to the Guidelines under this regulation. C. Notice Requirements. (1) Notice of Availability of an Income-Based Payment Plan. (a) Posted Notice. (i) A notice shall be posted in conspicuous places throughout the hospital, including the billing office, informing Maryland residents of the availability of an income-based payment plan and whom to contact at the hospital for additional information. (ii) If the hospital uses a vendor to assist with financial assistance eligibility, billing, or debt collection, such as a debt collector or eligibility vendor, the hospital shall ensure that the vendor posts a notice in a conspicuous place on their website or online payment portal, informing Maryland residents of the availability of an income-based payment plan and whom to contact at the hospital or debt collector for additional information. Placement on the website or online payment portal should be based on the best interest of the patient. (b) Information Sheet. A written notice of the availability of an income-based payment plan shall be contained in the information sheet required under Regulation .03 of this chapter, including clarity on the availability of income-based payment plans for Maryland residents, and, if payment plans for non-residents are included in the hospital’s credit and collection policy, the availability of such plans for non-residents. (c) Before a Prepayment Plan. Before a patient enters into a prepayment plan as described in §A(2) of this regulation for a medically necessary hospital service, a hospital shall provide a written notice of the availability of an income-based payment plan to a patient. (d) On a Bill. On the same page of the bill that includes the amount due and due date, the hospital shall provide notice that a lower monthly payment amount may be possible through an income-based plan, in the same font and style as the total amount due notification. (e) Online Payment Portal. On both the page of the online payment portal that states the amount due, and where the consumer enters the amount being paid by the consumer, the hospital shall provide, in the same font and style as the amount due notification, notice informing Maryland residents of the availability of an income-based monthly payment plan and information, including a telephone number and email address, in order to contact the hospital for additional information. (2) Notice of Terms Before Execution. A hospital shall provide written notice of the terms of an income-based payment plan to a patient before the patient agrees to enter the income-based payment plan. The terms of the income-based payment plan shall include: (a) The amount of medical debt owed to the hospital; (b) The interest rate applied to the income-based payment plan and the total amount of interest expected to be paid by the patient under the income-based payment plan; (c) The amount of each periodic payment expected from the patient under the income-based payment plan; (d) The number of periodic payments expected from the patient under the income-based payment plan; (e) The expected due dates for each payment from the patient; (f) The expected date by which the account will be paid off in full; (g) The treatment of any missed payments, including missed payments and default as described in §P and T of this regulation; (h) That there are no penalties for early payments; and (i) Whether the hospital plans to apply a periodic recalculation of monthly payment amounts as described in §N of this regulation and the process for such recalculation. (3) Notice of Plan After Execution. A hospital shall promptly provide a written income-based payment plan, including items listed in §C(2) of this regulation, to the patient following execution by all parties. The income-based payment plan shall be provided to the patient at least 20 days before the due date of the patient’s first payment under the income-based payment plan. D. Financial Assistance. (1) Before entering into an income-based payment plan with a patient, hospitals shall evaluate if the patient is eligible for financial assistance, including free and reduced-cost medically necessary care, including reduced-cost medically necessary care due to financial hardship, in accordance with Regulation .06 of this chapter. (2) Hospitals shall: (a) Apply the financial assistance reduction before entering into an income-based payment plan with a patient; and (b) Use any information collected for determining financial assistance under Regulation .06 of this chapter to establish the 5 percent monthly payment threshold for payment plans under Regulation .05F of this chapter. E. Offer Required. Hospitals must offer income-based payment plans that meet the requirements of these Guidelines. F. Monthly Payment Amounts. (1) Under an income-based payment plan subject to these Guidelines, a hospital may not require a patient to make total payments in a month that exceed 5 percent of the lesser of the patient’s household income. (2) §F(1) of this regulation applies to total amounts due under the plan, including both principal and interest, but does not apply to any catch-up payments, such as payments described under §P(1) of this regulation. (3) A hospital shall calculate the monthly payment amount threshold under §F(1) of this regulation by dividing income level by household size and multiplying by .05 percent. (4) Determining the Household Size. (a) The hospital shall determine the size of the patient’s household using the number reported on tax returns, if provided the number of tax filers and dependents listed on the tax return provided by the patient. For example, if a married couple files jointly and has three dependents, the number of tax filers and dependents would equal five. (b) If a patient files as an individual and the patient is not a dependent and has no dependents, the number of tax filers would equal one. (c) If the patient has not provided a tax return, the hospital shall ask the patient to provide the number of individuals in the household. G. Expenses. A hospital may reduce the amount of the monthly payment due under an income-based payment plan upon consideration of household expense information provided by a patient. H. Application to Multiple Income-based Payment Plans. (1) Hospitals. A hospital shall ensure that the total monthly payment amount for all income-based payment plans provided to a patient by the hospital, when added up collectively, does not exceed the income limitation under §F(1) of this regulation. (2) Hospital System. A hospital system shall ensure that the total monthly payment amount for all income-based payment plans provided to a patient by all hospitals in the hospital system, when added up collectively, does not exceed the income limitation under §F(1) of this regulation. I. Duration of Income-Based Payment Plan. The duration of an income-based payment plan, in months, is determined by the total amount owed, and interest, if interest applies, divided by the total amount of the payment due each month, subject to the limitation that no monthly payment may exceed 5 percent of the patient’s income as calculated under §F(1)of this regulation. J. Solicitation of Early Payments Prohibited. Hospitals may not solicit, steer, or mandate patients to pay an amount in excess of the monthly payment amount provided for in an income-based payment plan. K. Application of Partial Payments. A hospital shall apply partial payments in a manner most favorable to the patient. L. Interest and Fees. (1) No Interest for Patients Eligible for Financial Assistance. For a patient who is eligible for free or reduced-cost medically necessary care under the hospital’s financial assistance policy under Regulation .06 of this chapter and Health-General Article, §19–214.1, Annotated Code of Maryland, the hospital may not charge interest or fees on any medical debt amount owed under an income-based payment plan. (2) Allowable Interest. A hospital may charge interest under an income-based payment plan for a patient who is not eligible for free or reduced-cost medically necessary care, as described in §L of this regulation. A hospital is not required to charge interest for a payment plan. (3) Interest Rate. (a) An income-based payment plan may not provide for interest in excess of an effective rate of simple interest of 6 percent per annum on the unpaid principal balance of the payment plan. (b) A hospital may not set an interest rate that results in negative amortization. (c) Payers subject to Insurance Article, §15-1005, Annotated Code of Maryland, shall comply with its provisions. (4) Timing. Interest may not begin before 240 days after the initial bill is provided. (5) Late payments. A hospital may not charge additional fees or interest for late payments. M. Early Payment. (1) Prepayment Allowed. (a) Patients may, on a voluntary basis, pre-pay, in whole or in part, any amounts owed under an income-based payment plan. (b) Any prepayment made under §M(1) of this regulation is not subject to the monthly income payment limitations of §F(1) of this regulation. (2) No Fees or Penalties. A hospital may not assess fees or otherwise penalize early payment of an income-based payment plan. N. Limited Modifications of Income-based Payment Plans. (1) Change in Income. If a patient with an income-based payment plan notifies a hospital that the patient’s income has changed, then the hospital shall offer to modify the income-based payment plan to meet the requirement of §N(6) of this regulation. (2) Expenses. Before modifying an income-based payment plan, a hospital shall consider information provided by a patient about changes in household expenses in considering a patient request to modify a payment plan. (3) No Increase in Interest Rate. A hospital may not increase the interest rate on an income-based payment plan when making a modification to an income-based payment plan under this Guideline. (4) Limitation on Payment Amount. A hospital may not modify an income-based payment plan in a way that requires a patient to make a monthly payment that exceeds the percent of the patient’s income used to set the monthly payment amount under the initial income-based payment plan as provided for in §F of this regulation. (5) Change in Duration. The duration of a modified income-based payment plan, in months, is determined by the total amount owed, and interest, if interest applies, divided by the total amount of the payment due each month, subject to the limitation under §F of this regulation. (6) Process for Modifying an Income-Based Payment Plan. (a) Prompt Response to Patient Request. If a patient requests a modification to the terms of the payment plan, the hospital shall respond in a timely manner and may not refer the outstanding balance owed to a collection agency or for legal action until 30 days after providing a written response to the patient’s request for a modification of the payment plan. (b) Reconsideration for Financial Assistance. If a patient makes a request for modification of a payment plan, the hospital shall consider if such patient is eligible for financial assistance, including free medically necessary care, reduced-cost medically necessary care, and reduced-cost care due to financial hardship under Regulation .06 of this chapter. The hospital will apply the financial assistance reduction in its modification of the payment plan. (c) Mutual Agreement. A hospital may not modify a payment plan without mutual agreement between the hospital and the patient before the changes are made. (d) Notice of Terms. The hospital shall provide the patient with a written notice of all payment plan terms, consistent with the requirements of §C of this regulation, upon modifying a payment plan under this Guideline. O. Hospital-Initiated Changes to Income-Based Payment Plans Based on Changes to Patient Income. (1) Recalculation Allowed. A hospital may, in the terms of an initial income-based payment plan under §C(2) of this regulation that exceeds 3 years in length, provide for periodic recalculations to the amount of the monthly payments and the duration of the payment plan based on changes in the patient’s income as subject to and calculated under §N(5) of this regulation. (2) Notice Included in Initial Income-Based Payment Plan. (a) The hospital may only recalculate payment amounts under an income-based payment plan if the hospital included the process for such recalculation in the notice provided to the patient before they entered into the income-based payment plan, in accordance with §C(2) of this regulation. (b) The patient’s agreement to enter into the income-based payment plan after receiving that notice constitutes consent to the payment recalculations allowed under §P of this regulation. (3) Limitations on Modification Apply. The provisions of §N of this regulation relating to limitations of payment plan modifications apply to payment recalculations for income-based payment plans under §O of this regulation. (4) Frequency of Recalculation. A hospital may not seek a recalculation of the monthly payment amount under an income-based payment plan, as provided for under §O(1) of this regulation more than once every 3 years. (5) Treatment of Missing Information. If a patient does not provide income information on the request of the hospital seeking to make a change to an income-based payment plan under §O of this regulation and the patient is in good standing on the patient's payments under the income-based payment plan, the hospital may not change the monthly payment amounts under the income-based payment plan. P. Treatment of Missed Payments. (1) First Missed Payment. (a) A hospital may not deem a patient to be noncompliant with an income-based payment plan if the patient makes at least 11 scheduled monthly payments within a 12-month period. (b) Subject to §P(1)(c) of this regulation, the hospital shall permit the patient to repay the missed payment amount at any time, as determined by the patient, including through a set of partial payments. (c) No later than 30 days after the first missed payment in a 12-month period, the hospital shall notify the patient of the missed payment and inform the patient that the patient may be in default if they do not pay the amount of the missed payment within 12 months or if they miss additional payments within the 12-month period. The notice will give the patient the option to pay the missed payment by paying the amount of the missed payments in one of the following ways: (i) 11 increments over the subsequent 11 months; (ii) A single payment; or (iii) Another approach, as specified by the patient. (d) With respect to a patient that has missed a single monthly payment in a 12-month period, the hospital shall provide the patient with a method to designate whether any amount of a payment paid in the subsequent 12-month period is to be applied to the amount of missed payment or applied in a different manner. (e) With respect to a patient that has missed a single monthly payment in a 12-month period, if the hospital receives a payment and the patient has not designated how that payment is to be applied, the hospital shall first apply the amount to any payment that is due in the 31-day period following the date the payment is received. If there is no payment due in the next month, the hospital shall apply the amount of the payment to the missed payment. If the amount of the payment exceeds the amount of any payment that is due in the 31-day period following the date the payment is received, the excess amount shall be applied to the missed payment. (f) The hospital may consider a patient to be in default on the income-based payment plan if the missed payment is not repaid in full by the end of the 12-month period that begins on the date of the missed payment under §P(1) of this regulation. (2) Additional Missed Payments. (a) A hospital may forbear the amount of any additional missed payments that occur in a 12-month period. (b) If a hospital forbears the amount of any additional missed payments that occur in a 12-month period, the hospital shall allow the patient to continue to participate in the income-based payment plan. (c) If a hospital forbears the amount of any additional missed payments that occur in a 12-month period, the hospital may not refer the outstanding balance owed to a collection agency or for legal action. (d) The hospital shall recapitalize the amount of any missed payments that were subject to forbearance under this §P of this regulation as additional payments at the end of the income-based payment plan, thereby extending the length of the income-based payment plan. (e) The hospital shall provide written notice to the patient of the treatment of the missed payments, including any extension of the length of the income-based payment plan. Q. Treatment of Loans and Extension of Credit. After a hospital service is provided to the patient, a hospital, hospital affiliate, or third-party in partnership with a hospital may not make any loan or extension of credit to the patient in connection with a medically necessary hospital service that is inconsistent with the guidelines for payment plans in this regulation resulting from that service. R. Application of Credit Provisions of Maryland Commercial Law Article and Licensing Provisions of Financial Institutions Article. An income-based payment plan is an extension of credit subject to Maryland credit regulations under Commercial Law Article, Title 12, Annotated Code of Maryland and any applicable licensing provisions of Financial Institutions Article, Title 11, Annotated Code of Maryland. S. Books and Records. A hospital shall retain books and records on income-based payment plans for at least 3 years after the income-based payment plan is closed. T. Default. (1) If a patient defaults on an income-based payment plan and the parties are unable to agree to a modification, then the hospital shall follow the provisions of its credit and collection policy established in accordance with Regulation .04 of this chapter, before a hospital may write this medical debt off as bad debt. (2) With respect to the amounts covered by the income-based payment plans, a patient who is on an income-based payment plan and is not in default on that payment plan may not be considered in arrears on their debt to the hospital when the hospital is making decisions about scheduling health care services. U. Non-Income-Based Payment Plans. (1) Other Payment Plans Allowed. A hospital may offer a non-income-based payment plan under these Guidelines, but must first offer the patient an income-based payment plan. (2) Application of Guidelines. Consistent with the Guidelines for Hospital Payment Plans and consistent with the intent of Health-General Article, §19-214.2, Annotated Code of Maryland, the following provisions of this regulation apply to non-income-based payment plans in the same manner such provisions apply to income-based payment plans: (a) §A of this regulation, regarding scope; (b) §B of this regulation, regarding access to payment plans; (c) §C(2) of this regulation, regarding notice of payment plan terms before execution; (d) §C(3) of this regulation, regarding notice of plan after execution; (e) §D of this regulation, regarding financial assistance; (f) §L of this regulation, regarding interest and fees; (g) §M(1)(a) and (2) of this regulation, regarding early payments; (h) §N(6) of this regulation, regarding modifications of payment plans; (i) §Q of this regulation, relating to treatment of loans and extensions of credit; (j) §R of this regulation, relating to the application of credit provisions of Maryland Commercial Law Article and the licensing provisions of Financial Institutions Article; (k) §S of this regulation, relating to books and records; and (l) §T of this regulation, relating to default. (3) Notice. (a) Notice of Terms Before Execution. In addition to complying with the terms of §C(2) of this regulation, the hospital must include notice that the patient may apply for an income-based payment plan at any time in the notice of terms before execution of a non-income-based payment plan. (b) Notice of Plan After Execution. The hospital must include the notice required in §U(3)(a) of this regulation in the notice of the payment plan after execution that is required by §C(3) of this regulation. (c) Notice with Bills. Each bill for a non-income-based payment plan shall include a notice that informs the patient that income-based payment plans are available, which could result in lower monthly payments and provides information on how to apply for such plans. (4) Consent. Before entering into a non-income-based repayment plan with a patient, the hospital must obtain consent from the patient that records that the patient affirms the following: (a) The hospital offered the patient an income-based payment plan; (b) The income-based payment plan limits monthly payment amounts to 5 percent of the patient’s monthly income; (c) The income-based payment plan may result in lower monthly payment amounts than the monthly payment amounts under the non-income-based repayment plan; (d) The patient has the opportunity to disclose their income and determine the payment amount under the income-based payment plan; and (e) The patient is declining to enter an income-based payment plan and is consenting to enter a non-income-based repayment plan. (5) Modification of a Non-Income-Based Payment Plan: In addition to complying with the terms of §N(6) of this regulation, before modifying a non-income-based payment plan: (a) The hospital shall offer the patient an income-based payment plan; and, (b) If the patient declines the income-based payment plan, obtain the consent required under §U(4) of this regulation. (6) Default on a Non-Income-Based Payment Plan. (a) If the patient defaults on a non-income-based payment plan, the hospital must offer an income-based payment plan to the patient before the hospital follows the provisions of its credit and collection policy to collect the debt. (b) The offer provided under §U(6)(a) of this regulation must be sent separately from a bill. V. Steering. (1) A hospital may not steer patients to non-income-based payment plans, or third-party credit providers, in such a manner that discourages patients from entering into income-based payment plans. (2) A hospital may not steer patients to revolving credit products in such a manner that discourages patients from entering into either income-based payment plans or non-income based payment plans under this regulation. #### Regulation .06 Hospital Financial Assistance Responsibilities. *COMAR 10.37.13.06* A. Financial Assistance Policy. (1) Requirements. (a) Each hospital and each chronic care hospital under the jurisdiction of the Commission shall develop a written financial assistance policy for providing free and reduced-cost medically necessary care to low-income patients who lack health care coverage or to patients whose health insurance does not pay the full cost of the hospital bill. (b) A hospital shall provide written notice of the hospital's financial assistance policy to the patient, the patient's family, or the patient's authorized representative before discharging the patient and in each communication to the patient regarding collection of the hospital bill. (i) The required notice shall state that the patient has up to 240 days after the day the patient receives the initial hospital bill to apply for financial assistance from the hospital. (ii) The hospital shall obtain documentation ensuring that the patient or the patient’s authorized representative acknowledges the patient’s receipt of the notice before discharging the patient. (iii) If a patient chooses not to apply for financial assistance, the patient’s documented acknowledgement shall indicate that the patient is not applying for financial assistance on the day of the acknowledgment but may apply within 240 days immediately following the patient’s receipt of the initial hospital bill. (c) The financial assistance policy shall provide at a minimum: (i) Free medically necessary care to patients with family income at or below 200 percent of the federal poverty level, consistent with the provisions of §A(2) of this regulation; (ii) Reduced-cost medically necessary care to patients with family income between 200 and 300 percent of the federal poverty level, consistent with the provisions of §A(2) of this regulation; (iii) A description of the payment plan required under Health-General Article, §19-214.2(d), Annotated Code of Maryland and Regulation .05 of this chapter; and (iv) A mechanism for a patient, irrespective of that patient’s insurance status, to request the hospital to reconsider the denial of free or reduced-cost medically necessary care, including the address, phone number, facsimile number, email address, mailing address, and website of the Health Education and Advocacy Unit, which can assist the patient or patient’s authorized representative in filing and mediating a reconsideration request. (d) If a patient is eligible for reduced-cost medically necessary care under §A(1)(c)(ii) of this regulation, the hospital shall, at a minimum, reduce the patient’s out-of-pocket expenses for the hospital services: (i) For a patient with family income of at least 201 percent but not more than 250 percent of the federal poverty level, by 75 percent; and (ii) For a patient with family income of more than 250 percent but not more than 300 percent of the federal poverty level, by 60 percent. (e) The hospital shall provide free and reduced-cost medically necessary care to all qualified Maryland residents, regardless of their citizenship or immigration status. (f) The hospital shall provide free and reduced-cost medically necessary care under §A(1)(c) of this regulation to all qualified Maryland residents, regardless of whether the patient resides in the hospital’s service area. (g) The financial assistance policy applies to all medically necessary hospital services provided to qualified Maryland residents. Hospitals may not exclude non-urgent or elective, but medically necessary, care from their financial assistance policy. (2) The financial assistance policy shall calculate a patient’s eligibility for free medically necessary care under §A(1)(c)(i) of this regulation and Health-General Article, §19-214.1(b)(2)(i), Annotated Code of Maryland, or reduced-cost medically necessary care under §A(1)(c)(ii) of this regulation and Health-General Article, §19-214.1(b)(2)(ii), Annotated Code of Maryland, at the date of service or updated, as appropriate, to account for any change in the financial circumstances of the patient that occurs within 240 days after the initial bill is provided. (3) The hospital shall consider any change in the patient’s financial circumstance in accordance with Health-General Article, §19-214.1(b)(11), Annotated Code of Maryland. (4) Income Documentation. (a) Hospitals shall accept generally acceptable forms of documentation that verify income, such as tax returns, pay stubs, and W2s to evaluate if the patient is eligible for financial assistance, including free and reduced-cost medically necessary care, including reduced-cost medically necessary care due to financial hardship, in accordance with this regulation . (b) Hospitals shall use available information, including information provided by the patient, to approximate the patient’s income if the patient has not provided their tax returns, pay stubs, W2s, or another form of documentation. (c) Income Attestations. (i) Hospitals may accept patient attestation of the patient’s monthly or annual income and the number of filers and dependents on their tax return without documentation. (ii) Such an attestation shall include the patient’s income and the number of filers and dependents on their tax return. (iii) If the patient provides an attestation of income the hospital is not required to conduct any additional income verification. (d) A hospital’s inability to obtain complete income information does not preclude the hospital's ability to reasonably predict a patient’s income for the purposes of providing financial assistance. For example, a hospital may multiply income reported at the monthly level by 12 to determine income at the annual level, allowing for reasonably predictable changes in income throughout the year. (5) Presumptive Eligibility for Free Medically Necessary Care. Unless otherwise eligible for Medicaid or CHIP, patients who are beneficiaries/recipients of the following means-tested social services programs are deemed eligible for free medically necessary care: (a) Households with a child in the free or reduced lunch program and is eligible for the program based on the household’s income; (b) Supplemental Nutritional Assistance Program (SNAP); (c) Low-income-household energy assistance program; (d) Primary Adult Care Program (PAC), until such time as inpatient benefits are added to the PAC benefit package; (e) Women, Infants and Children (WIC); or (f) Other means-tested social services programs deemed eligible for hospital free medically necessary care policies by the Maryland Department of Health and the Commission, consistent with this regulation. B. Hospital Reports. Each hospital shall submit to the Commission within 120 days after the end of each hospital’s fiscal year: (1) The hospital’s financial assistance policy developed in accordance with this regulation; and (2) An annual report on the hospital's financial assistance policy that includes: (a) The total number of patients who completed or partially completed an application for financial assistance during the prior year; (b) The total number of inpatients and outpatients who received free medically necessary care during the immediately preceding year and reduced-cost medically necessary care for the prior year; (c) The total number of patients who received financial assistance during the immediately preceding year, by race or ethnicity and gender; (d) The total number of patients who were denied financial assistance during the immediately preceding year, by race or ethnicity and gender; (e) The total cost of hospital services provided to patients who received free medically necessary care; and (f) The total cost of hospital services provided to patients who received reduced-cost medically necessary care that was covered by the hospital as financial assistance or that the hospital charged to the patient. C. Financial Hardship Policy. (1) Subject to Regulation .05D of this chapter, the financial assistance policy required under §A of this regulation and Health-General Article, §19-214.1, Annotated Code of Maryland, shall provide reduced-cost medically necessary care to patients with family income below 500 percent of the federal poverty level who have a financial hardship. (2) If a patient has received reduced-cost medically necessary care due to a financial hardship, the patient or any immediate family member of the patient living in the same household: (a) Shall remain eligible for reduced-cost medically necessary care when seeking subsequent care at the same hospital during the 12-month period beginning on the date on which the reduced-cost medically necessary care was initially received; and (b) To avoid an unnecessary duplication of the hospital’s determination of eligibility for free and reduced-cost medically necessary care, shall inform the hospital of the patient’s or family member’s eligibility for the reduced-cost medically necessary care. (3) If a patient is eligible for reduced-cost medically necessary care under a hospital’s financial hardship policy, the hospital shall, at a minimum, reduce the patient’s out-of-pocket expenses for hospital services: (a) For a patient with family income of at least 201 percent but not more than 250 percent of the federal poverty level, by 75 percent; (b) For a patient with family income of more than 250 percent but not more than 300 percent of the federal poverty level, by 60 percent; (c) For a patient with family income of more than 300 percent but not more than 350 percent of the federal poverty level, by 50 percent; (d) For a patient with family income of more than 350 percent but not more than 400 percent of the federal poverty level, by 45 percent; (e) For a patient with family income of more than 400 percent but not more than 450 percent of the federal poverty level, by 40 percent; and (f) For a patient with family income of more than 450 percent but not more than 500 percent of the federal poverty level, by 35. D. The Commission may, by regulation, establish income thresholds higher than those in this regulation: (a) Patient mix; (b) Financial condition; (c) Level of bad debt experienced; (d) Amount of financial assistance provided; and (e) Other relevant factors. E. Notice Requirements. (1) A notice shall be posted in conspicuous places throughout the hospital including the billing office informing patients of their right to apply for financial assistance and who to contact at the hospital for additional information. (2) If the hospital uses a vendor to assist with financial assistance eligibility, billing, or debt collection, such as a debt collector or eligibility vendor, that vendor shall post a notice in a conspicuous place on their website or online payment portal, informing patients of their right to apply for financial assistance, providing a link to the financial assistance application, and providing information on how to submit the application. Placement on the website or online payment portal should be based on the best interest of the patient. F. The notice required under §E of this regulation shall be in: (1) Simplified language; (2) At least 10-point type; and (3) The patient’s preferred language or, if no preferred language is specified, each language spoken by a limited English proficient population that constitutes at least 5 percent of the overall population within the city or county in which the hospital is located as measured by the most recent census. G. Financial Assistance Application. Each hospital shall: (1) Use a Financial Assistance Application in the manner prescribed by the Commission in order to determine eligibility for free and reduced-cost medically necessary care; (2) Use a Financial Assistance Application that meets the requirements of this regulation and is consistent with the Uniform Financial Assistance Application; and (3) Establish a mechanism to provide a Financial Assistance Application to patients regardless of their insurance status. A hospital may require from patients or their guardians only those documents required to validate the information provided on the application. H. Asset Test Requirements. A hospital may utilize a monetary asset test when determining eligibility for financial assistance, using the definition of monetary assets as defined in Regulation 01B of this chapter. #### Regulation .07 Patient Complaints. *COMAR 10.37.13.07* A. The Commission shall post a process on its website for a patient or a patient’s authorized representative to file with the Commission a complaint against a hospital for an alleged violation of Health-General Article, §§19-214.1 or 19-214.2, Annotated Code of Maryland. B. The process established by the Commission shall include the option for a patient or a patient’s authorized representative to file the complaint jointly with the Commission and the Health Education and Advocacy Unit. C. The process shall conform to the requirements of Health-General Article, §19-214.3, Annotated Code of Maryland. #### Regulation .08 Hospital Written Estimate. *COMAR 10.37.13.08* A. In addition to the good faith estimate requirements set forth in the Public Health Service Act, 42 U.S.C §2799B-6, the No Surprises Act, on request of a patient made before or during treatment, a hospital shall provide to the patient a written estimate of the total charges for the hospital services, procedures, and supplies that reasonably are expected to be provided and billed to the patient by the hospital. B. The written estimate shall state clearly that it is only an estimate and actual charges could vary. C. A hospital may restrict the availability of a written estimate to normal business office hours. D. The provisions set forth in §A—C of this regulation do not apply to emergency services. #### Regulation .09 Other Obligations of Debt Collectors. *COMAR 10.37.13.09* This chapter does not diminish any obligations of a debt collector, as defined under Regulation .01 of this chapter, under other applicable laws or regulations, including, without limitation, any requirement for the debt collector to obtain a collection agency license from the State Collection Agency Licensing Board in accordance with Business Regulation Article, Title 7, Subtitle 3, Annotated Code of Maryland. ## Subtitle 38 — Board of Physical Therapy Examiners ### Chapter 01 — General Regulations **Authority:** Health Occupations Article, §§1-101, 13-101, 13-206, 13-301—13-303, 13-305—13-307, 13-310, 13-311, 13-313, and 13-317, Annotated Code of Maryland **Administrative History:** Effective date: December 25, 1974 (1:6 Md. R. 299) **Administrative History:** Regulation .01J amended effective June 29, 1979 (6:13 Md. R. 1129) **Administrative History:** Regulations .01—.03 repealed effective August 2, 1982 (9:15 Md. R. 1514) **Administrative History:** Regulations .01—.04 adopted effective August 2, 1982 (9:15 Md. R. 1514) **Administrative History:** Regulations .01—.04 repealed effective December 29, 1986 (13:26 Md. R. 2807) **Administrative History:** Regulations .01—.05 adopted effective December 29, 1986 (13:26 Md. R. 2807) **Administrative History:** Regulation .01B amended effective July 8, 1991 (18:13 Md. R. 1482); February 26, 1996 (23:4 Md. R. 273); July 12, 1999 (26:14 Md. R. 1083) Regulation .01B amended as an emergency provision effective January 1, 2001 (28:3 Md. R. 203); amended permanently effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulation .01B amended effective April 24, 2006 (33:8 Md. R. 734); April 6, 2009 (36:7 Md. R. 525); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .02 amended effective April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .02A—C amended effective July 8, 1991 (18:13 Md. R. 1482) **Administrative History:** Regulation .02D amended effective June 8, 2015 (42:11 Md. R. 725) **Administrative History:** Regulation .03A amended effective July 8, 1991 (18:13 Md. R. 1482) **Administrative History:** Regulation .04 amended effective April 6, 2009 (36:7 Md. R. 525); April 2, 2012 (39:6 Md. R. 408); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .04A amended effective July 8, 1991 (18:13 Md. R. 1482); July 12, 1999 (26:14 Md. R. 1083) **Administrative History:** Regulation .04B amended effective July 12, 1999 (26:14 Md. R. 1083) **Administrative History:** Regulation .05 amended effective April 24, 2006 (33:8 Md. R. 734) **Administrative History:** Regulation .05C amended effective July 8, 1991 (18:13 Md. R. 1482) **Administrative History:** Regulation .05E adopted effective June 8, 2015 (42:11 Md. R. 725) #### Regulation .01 Definitions. *COMAR 10.38.01.01* A. In this subtitle, the following terms have the meanings indicated. B. Terms Defined. (1) “Approved agency” means an independent credentialing agency, approved by the Board, which evaluates the credentials of foreign-trained applicants. (2) “Approved curriculum for physical therapist assistants” means a curriculum that is approved by the American Physical Therapy Association. (3) “Approved physical therapy curriculum” means a curriculum for physical therapists that is approved by the American Medical Association or the American Physical Therapy Association. (4) “Biennial renewal” means renewal every other year with even-numbered licenses being renewed in even-numbered years and odd-numbered licenses being renewed in odd-numbered years. (5) “Board” means the Board of Physical Therapy Examiners of Maryland established by Health Occupations Article, §13-201, Annotated Code of Maryland. (6) “Direct supervision” means supervision provided by a licensed physical therapist who is physically present within the treatment area and immediately available to give aid, direction, and instruction when physical therapy or limited physical therapy procedures or activities are performed. (7) “Hearing committee” means a committee of three or more Board members that has been delegated the authority to conduct hearings in accordance with Health Occupations Article, §13-317, Annotated Code of Maryland. (8) “Interview” means a meeting with the Board or with one or more of its representatives. (9) Licensed Physical Therapist. (a) “Licensed physical therapist” means an individual licensed by the Board to practice physical therapy in Maryland; and (b) “Licensed physical therapist” includes an individual holding a compact privilege to practice physical therapy in Maryland. (10) Licensed Physical Therapist Assistant. (a) “Licensed physical therapist assistant” means an individual licensed by the Board to practice limited physical therapy in Maryland; and (b) “Licensed physical therapist assistant” includes an individual holding a compact privilege to practice limited physical therapy in Maryland. (11) “Licensing examinations” means the written examinations approved by the Board consisting of the: (a) National licensing examination; and (b) Maryland Physical Therapy jurisprudence examination. (12) “Ongoing supervision” means that the physical therapist maintains continuing verbal and written contact with the physical therapist assistant to provide supervision and instruction adequate to ensure the safety and welfare of the patient. (13) “Oral competency” means that the applicant who did not graduate from a recognized English-speaking educational institution has obtained a passing score, as determined by the Board, on the Test of English as a Foreign Language administered by the Educational Testing Service. (14) “Passing score” means the result of two examinations: (a) The criterion-referenced score set by the Federation of State Boards of Physical Therapy; and (b) 90 percent of the total on the Maryland Physical Therapy jurisprudence examination. (15) “Physical therapy aide” or “aide” means a person who performs certain physical therapy duties under the direct supervision of a licensed physical therapist. This individual may be known, also, as a physical therapist technician, a rehabilitation technician, an athletic trainer, or be described by some other similar title. (16) “Reporting service” means the Interstate Reporting Service, an agency approved by the Board for the purpose of recording, storing, and transmitting license examination scores. (17) “State” means: (a) A state, possession, or territory of the United States; (b) The District of Columbia; or (c) The Commonwealth of Puerto Rico. (18) “Student” means an individual who is supervised directly by a licensed physical therapist in a Board-approved physical therapy educational program. (19) “Temporary license” means a license issued by the Board to an individual who has completed the approved curriculum requirements to practice, while under direct supervision, as a: (a) Physical therapist; or (b) Physical therapist assistant. (20) “Verification” means confirmation of licensure obtained directly from the state in which the applicant is currently licensed, on a form provided by the Board. (21) “Waiver of national licensing examination” means that the Board may waive the national licensing examination if the applicant previously took the examination in another state and met the requirements for a passing score as set forth in §B(14) of this regulation. (22) “Written competency” means that the applicant who did not graduate from a recognized English-speaking educational institution has obtained a passing score, as determined by the Board, on the Test of English as a Foreign Language administered by the Educational Testing Service. #### Regulation .02 Requirements for Licensure. *COMAR 10.38.01.02* The following are requirements for an applicant educated in an approved physical therapy or approved physical therapist assistant curriculum in any state: A. Examination. The following shall be filed with the Board or the Board’s agent: (1) An application on the form the Board requires; (2) The application and national licensing examination fees established in COMAR 10.38.07; and (3) Proof of completion of: (a) A physical therapy or physical therapist assistant curriculum; and (b) Any clinical training required under the curriculum. B. Transfer of Examination Scores. The following shall be filed with the Board or the Board’s agent: (1) An application on the form the Board requires; (2) The application fee established in COMAR 10.38.07; (3) Proof of completion of: (a) A physical therapy or physical therapist assistant curriculum; and (b) Any clinical training required under the curriculum; (4) A sworn statement that the applicant is not now nor has ever been licensed in another state; (5) Evidence, satisfactory to the Board, that the applicant is registered to take, or has taken, the national licensing examination in another state; and (6) A copy of a letter or form to the appropriate reporting service requesting that licensing examination scores be sent to the Board. C. Waiver of Examination. The following shall be filed with the Board or the Board’s agent: (1) An application on the form the Board requires; (2) The application fee established in COMAR 10.38.07; (3) Proof of completion of: (a) A physical therapy or physical therapist assistant curriculum; and (b) Any clinical training required under the curriculum; (4) A copy of a current physical therapy license; (5) Verification of current license on the form the Board requires; and (6) A copy of a letter or form to the appropriate reporting service requesting that licensing examination scores be sent to the Board. D. Additional Requirements. Applicants for licensure shall: (1) Achieve a passing score on the licensing examinations; and (2) Submit to a State and national criminal history records check in accordance with Health Occupations Article, §13–302.1, Annotated Code of Maryland. #### Regulation .03 Reexamination. *COMAR 10.38.01.03* A. National Licensing Examination. (1) An applicant who fails the examination shall repeat the examination. (2) Fees. (a) At least 6 weeks before the examination, the applicant shall pay to the Board the reexamination fee as established in COMAR 10.38.07. (b) If the applicant has taken the licensing examination twice in Maryland, the applicant shall pay to the Board an application fee, as established in COMAR 10.38.07, in addition to the reexamination fee. B. Examination on Maryland Physical Therapy Law. An applicant who fails the examination on the Maryland Physical Therapy Practice Act and associated regulations shall: (1) Repeat the examination; and (2) Attend an interview unless the Board waives this requirement. #### Regulation .04 Issuance of Licenses. *COMAR 10.38.01.04* A. Temporary License. (1) The Board may issue a temporary license to an applicant who, except for passing an examination otherwise required under Health Occupations Article, Title 13, Annotated Code of Maryland, has met the appropriate education and experience requirements for a physical therapy license or a physical therapist assistant license set forth under Health Occupations Article, §13-302, Annotated Code of Maryland. (2) The holder of a temporary license shall: (a) Practice under direct supervision while the temporary license is in effect; (b) Achieve a passing score on the Maryland Physical Therapy jurisprudence exam; and (c) Submit to a State and national criminal history records check in accordance with Health Occupations Article, §13-302.1, Annotated Code of Maryland. (3) A temporary license is valid until: (a) 90 days after issuance; (b) The Board issues a full license to practice physical therapy or limited physical therapy to the holder of the temporary license; or (c) The Board revokes the temporary license. B. Licensure Procedures. (1) When the applicant has met all the requirements for licensure, the Board may issue a physical therapist or physical therapist assistant license to the applicant. (2) Renewal of Physical Therapist or Physical Therapist Assistant License. (a) The licensee shall renew the license biennially. (b) The licensee shall be responsible for notifying the Board if a renewal notice is not received. (c) A renewal license shall be issued to each licensee who meets the requirements of Health Occupations Article, §13-311(c), Annotated Code of Maryland. (3) Method of Renewal Notification. (a) Except as otherwise provided in §B(3)(b) of this regulation, the Board shall mail notices for renewal at least 1 month before the expiration date. (b) If requested by a licensee, the Board shall send to the licensee, at least two times within the month before a license expires, a renewal notice by electronic means to the last known electronic mail address of the licensee. (c) If a renewal notice sent by electronic mail under §B(3)(b) of this regulation is returned to the Board as undeliverable, the Board shall send to the licensee a renewal notice by first-class mail to the last known address of the licensee. (4) A duplicate license shall be issued for a lost, stolen, or destroyed license provided the licensee: (a) Makes a request in writing; (b) Provides a sworn statement or police report attesting to the facts; and (c) Pays the fee as established in COMAR 10.38.07. #### Regulation .05 Restrictions. *COMAR 10.38.01.05* A. The Board may refuse to grant a license to any applicant who begins practice as a physical therapist or a physical therapist assistant before being licensed to practice in Maryland. B. Practice after the date of expiration of the license is prohibited. C. An applicant shall complete the application process within 1 year of the date of the paid application or reapply for licensure. D. The Board may refuse to grant or renew a license to an applicant who has failed to pay all outstanding fees to the Board. E. The Board may not issue a license under this subtitle if the results of the criminal history records check required pursuant to Regulation .02D(3) of this chapter has not been received. ### Chapter 02 — Code of Ethics **Authority:** Health-General Article, §2-1004; Health Occupations Article, §§1-212, 13-206, and 13-316; Annotated Code of Maryland **Administrative History:** Effective date: April 6, 1979 (6:7 Md. R. 577) **Administrative History:** Regulations .01—.03 repealed and new regulations .01 and .02 adopted effective August 2, 1982 (9:15 Md. R. 1514) **Administrative History:** Regulation .01A amended effective April 4, 2022 (49:7 Md. R. 467) **Administrative History:** Regulation .01C amended effective April 24, 2006 (33:8 Md. R. 734) **Administrative History:** Regulation .01G adopted effective September 18, 2000 (27:18 Md. R. 1665) **Administrative History:** Regulation .01H—L adopted effective March 18, 2002 (29:5 Md. R. 504) **Administrative History:** Regulation .02 amended effective November 7, 1994 (21:22 Md. R. 1877) **Administrative History:** Regulation .02 amended and recodified to Regulation .03 and new Regulation .02 adopted effective September 6, 1999 (26:18 Md. R. 1376) #### Regulation .01 Code of Ethics. *COMAR 10.38.02.01* A. The physical therapist and physical therapist assistant shall provide care regardless of the patient's: (1) Race; (2) Religion; (3) Color; (4) Age; (5) National origin; (6) Marital status; (7) Sexual orientation; (8) Gender identity; or (9) Disability. B. The physical therapist and the physical therapist assistant shall respect the dignity of the patient. C. The physical therapist and physical therapist assistant shall protect the patient's right to privacy by not divulging confidential information without consent of the patient or guardian unless required by law. D. The physical therapist shall provide information about fees upon request by the patient. E. The physical therapist may not dispense or supply physical therapy equipment unless it is in the best interest of the patient. F. The physical therapist and physical therapist assistant shall report to the Board of Physical Therapy Examiners all information that indicates a person is allegedly performing, or aiding and abetting, the illegal or unsafe practice of physical therapy. G. The physical therapist and the physical therapist assistant shall comply with the probationary conditions of a Board order. H. A licensee shall notify the Board in writing within 60 days if any license, certificate, permit, or registration granted by another state for the practice of physical therapy or limited physical therapy has been limited, restricted, suspended, revoked, or subjected to other disciplinary action by the licensing or certifying authority. I. The physical therapist and physical therapist assistant shall provide and maintain medical records in accordance with Health-General Article, §§4-301—4-402, Annotated Code of Maryland. J. The physical therapist or physical therapist assistant may not knowingly or willfully destroy, damage, alter, obliterate, or otherwise obscure a medical record or billing record or other information about a patient in an effort to conceal the information from use as evidence in an administrative, civil, or criminal proceeding. K. The physical therapist or physical therapist assistant may not intimidate or influence any person to withhold or change testimony in hearings or proceedings before the Board or those otherwise delegated to the Office of Administrative Hearings. L. The physical therapist or physical therapist assistant may not hinder, prevent, or otherwise delay any person from making information available to the Board in furtherance of any investigation of the Board. #### Regulation .02 Sexual Misconduct. *COMAR 10.38.02.02* A. A physical therapist or physical therapist assistant may not engage in sexual misconduct. B. Sexual misconduct includes, but is not limited to: (1) Sexual behavior with a client or patient in the context of a professional evaluation, treatment, procedure, or service to the client or patient, regardless of the setting in which the professional service is rendered; (2) Sexual behavior with a client or patient under the pretext of diagnostic or therapeutic intent or benefit; (3) Solicitation of a sexual relationship, whether consensual or nonconsensual, with a patient; (4) Sexual advances requesting sexual favors; (5) Therapeutically inappropriate or intentional touching of a sexual nature; (6) A verbal comment of a sexual nature; (7) Physical contact of a sexual nature with a patient; (8) Discussion of unnecessary sexual matters while treating a patient; (9) The taking of photographs of patients for a sexual purpose; (10) Sexual harassment of staff or students; (11) An unnecessary sensual act or comment; or (12) Sexual contact with an incompetent or unconscious patient. #### Regulation .03 Penalties. *COMAR 10.38.02.03* Violation of Regulation .01 or .02 of this chapter may result in the Board taking action to reprimand a licensee or place the licensee on probation, or suspend or revoke the licensee's license. The Board may also impose a penalty not exceeding $5,000. ### Chapter 03 — Standards of Practice **Authority:** Health Occupations Article, §§13-206, 13-309, and 13-310, Annotated Code of Maryland **Administrative History:** Effective date: August 2, 1982 (9:15 Md. R. 1515) **Administrative History:** Regulation .01B amended effective January 20, 1991 (19:1 Md. R. 33); December 19, 1994 (21:25 Md. R. 2106); April 16, 2001 (28:7 Md. R. 690); March 18, 2002 (29:5 Md. R. 504); March 31, 2003 (30:6 Md. R. 421); April 24, 2006 (33:8 Md. R. 734) **Administrative History:** Regulation .02 amended effective December 19, 1994 (21:25 Md. R. 2106) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective March 18, 2002 (29:5 Md. R. 504) **Administrative History:** Regulation .02 amended effective March 31, 2003 (30:6 Md. R. 421) **Administrative History:** Regulation .02A amended as an emergency provision effective May 23, 2002 (29:12 Md. R. 924; amended permanently effective September 2, 2002 (29:17 Md. R. 1381) **Administrative History:** Regulation .02A amended effective April 24, 2006 (33:8 Md. R. 734); February 25, 2008 (35:4 Md. R. 515); April 4, 2022 (49:7 Md. R. 466) **Administrative History:** Regulation .02R amended effective January 1, 1996 (22:26 Md. R. 2030) **Administrative History:** Regulation .02-1 adopted effective January 20, 1992 (19:1 Md. R. 33) **Administrative History:** Regulation .02-1B amended effective December 19, 1994 (21:25 Md. R. 2106) **Administrative History:** Regulation .02-1 repealed and new Regulation .02-1 adopted effective March 18, 2002 (29:5 Md. R. 504) **Administrative History:** Regulation .02-1 amended effective April 24, 2006 (33:8 Md. R. 734) **Administrative History:** Regulation .03 amended effective December 19, 1994 (21:25 Md. R. 2106) #### Regulation .01 Definitions. *COMAR 10.38.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Board” means the Board of Physical Therapy Examiners of Maryland created by Health Occupations Article, §13-201, Annotated Code of Maryland. (2) “Clinical treatment hour” means an hour in which physical therapy or limited physical therapy services are provided at some point during the hour. (3) “Electronically signed” means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. (4) “Evaluations” means procedures which include, but are not limited to: (a) Testing of strength, sensation, and reflexes; (b) Goniometric measurements and their interpretation; (c) Assessments of function, muscle tone, developmental levels, accessory motions, posture, and pain scale. (5) “Goals” means the expected outcome as the result of therapy. (6) “Group therapy” means treatment procedures provided simultaneously to two or more patients that: (a) Require constant attendance, but not one-on-one contact by the physical therapist or physical therapist assistant; and (b) Can be, but need not be, the same treatment procedures. (7) "History" means data that is pertinent to the current physical therapy problem. (8) “Hour” means a 60-minute increment during a calendar day which is calculated by dividing the day into consecutive 60-minute increments beginning when the day's first physical therapy or limited physical therapy service starts and ending when the last physical therapy or limited physical therapy service terminates, the last consecutive increment of which may be a fraction of an hour. (9) “Interpretation” means the analysis of findings for the purpose of establishing and justifying the plan of care. (10) “License number” means the Maryland physical therapy license number issued by the Board. (11) “Onset” means the date of occurrence of the condition for which physical therapy is being provided. (12) “Physical therapy diagnosis” means the condition for which physical therapy is provided if different from the medical diagnosis. (13) “Plan of care” means the plan of treatment aimed at achieving the anticipated functional goals. (14) “Progress” means the measurable improvement as related to goals. (15) “Reevaluation” means a measurement of progress, or lack of it, based on comparisons of tests, measurements, and assessments with previous evaluation or reevaluations. (16) “Requirements for documentation” means the requirements as set forth in Regulation .02-1 of this chapter and approved by the Board. (17) “Response to treatment” means a brief statement of the patient's condition at conclusion of treatment. (18) “Services” means the evaluation or treatment, or both, as appropriate, of a patient. (19) “Signature and title” means the name of the physical therapist or physical therapist assistant written by that person or electronically signed by that person in accordance with federal and State law and followed by the title “PT” or “PTA” and license number. A stamp of a signature is not acceptable as a signature for documentation. (20) “Student” means an individual who is currently enrolled in a physical therapy or physical therapist assistant educational program approved by the Board. (21) “Supervising physical therapist” means a physical therapist who provides ongoing supervision to a physical therapist assistant regarding the care of a patient. (22) “Supportive personnel” includes aides and other unlicensed personnel. (23) “Test results” means the measurable and objective findings obtained from the evaluations. #### Regulation .02 Standards of Practice. *COMAR 10.38.03.02* A. Physical Therapists. (1) The physical therapist who establishes or changes the plan of care shall be ultimately responsible for patient care until another physical therapist: (a) Provides services to the patient; or (b) Provides supervision to the treating physical therapist assistant. (2) The physical therapist shall: (a) Exercise sound professional judgment in the use of evaluation and treatment procedures; (b) Provide: (i) Physical therapy services to not more than an average of three patients per clinical treatment hour per calendar day, excluding group therapy; and (ii) Each patient with adequate treatment time consistent with accepted standards in delivering physical therapy care; (c) Provide the patient with accurate information about the physical therapy services provided; (d) Respect the right of the patient to refuse treatment; (e) Evaluate the patient and develop a plan of care before the patient is treated; (f) Work within the physical therapist's competency in physical therapy evaluation and treatment; (g) Reevaluate the patient as the patient's condition requires, but at least every 30 days, unless the physical therapist, consistent with accepted standards of physical therapy care, documents in the treatment record an appropriate rationale for not reevaluating the patient; (h) Provide direct supervision of students, aides, and individuals practicing under a temporary license; (i) Ascertain and periodically reevaluate the ability of students and aides to perform the assigned duties; (j) Delegate to the physical therapist assistant only treatment that is within the competency and scope of practice of the physical therapist assistant; (k) Provide direction and instruction for the physical therapist assistant that is adequate to ensure the safety and welfare of the patient; and (l) Document ongoing communication with the physical therapist assistant regarding changes in a patient's status and treatment plan. (3) The physical therapist may: (a) Enter into an agreement or employment relationship provided that such agreement or relationship does not impede the physical therapist's exercise of independent judgment in the treatment of a patient or cause the physical therapist to practice physical therapy contrary to the Maryland Physical Therapy Act; and (b) Decline to carry out evaluation or treatment of a patient who has been referred to the physical therapist by a health care practitioner if: (i) In the physical therapist's judgment, the evaluation or treatment is contraindicated or unjustified; and (ii) The physical therapist documents the decision in the patient's record. B. Physical Therapist Assistants. (1) The physical therapist assistant shall: (a) Follow the direction and plan of care of the physical therapist in the treatment of a patient; (b) Exercise sound judgment and adequate care in the performance of duties; (c) Immediately discontinue any treatment procedure that appears to be harmful to the patient and so notify the supervising physical therapist; (d) Use only methods and procedures within the scope of the practice of limited physical therapy; (e) Respect the right of the patient to refuse treatment; (f) Work within the physical therapist assistant's competency in treatment that is within the scope of practice of limited physical therapy; (g) Document ongoing communication regarding changes in a patient's status and treatment authorized by the physical therapist; and (h) Provide the following services: (i) Treat not more than an average of three patients per clinical treatment hour per calendar day, excluding group therapy; and (ii) Provide each patient with adequate treatment time consistent with accepted standards in physical therapy care. (2) The physical therapist assistant may: (a) Enter into an agreement or employment relationship provided that the agreement or relationship does not impede the physical therapist assistant's exercise of appropriate patient treatment or cause the physical therapist assistant to practice limited physical therapy in violation of the Maryland Physical Therapy Act; and (b) Participate in the clinical education activities of a physical therapist assistant student if direct supervision of the student is provided by the physical therapist. (3) The physical therapist assistant may not initiate treatment until: (a) The patient has been evaluated and the plan of care has been developed by a physical therapist; and (b) A supervising physical therapist has been assigned to the physical therapist assistant. #### Regulation .02-1 Requirements for Documentation. *COMAR 10.38.03.02-1* A. The physical therapist shall document legibly the patient's chart each time the patient is seen for: (1) The initial visit, by including the following information: (a) Date; (b) Condition, or diagnosis, or both, for which physical therapy is being rendered; (c) Onset; (d) History, if not previously recorded; (e) Evaluation and results of tests (measurable and objective data); (f) Interpretation; (g) Goals; (h) Modalities, or procedures, or both, used during the initial visit and the parameters involved including the areas of the body treated; (i) Plan of care including suggested modalities, or procedures, or both, number of visits per week, and number of weeks; and (j) Signature, title (PT), and license number. (2) Subsequent visits, by including the following information (progress notes): (a) Date; (b) Cancellations, no-shows; (c) Modalities, or procedures, or both, with any changes in the parameters involved and areas of body treated; (d) Objective status; (e) Response to current treatment, if any; (f) Changes in plan of care; and (g) Signature, title (PT), and license number, although the flow chart may be initialed. (3) Reevaluation, by including the following information in the report, which may be in combination with the visit note, if treated during the same visit: (a) Date; (b) Number of treatments since the initial evaluation or last reevaluation; (c) Reevaluation, tests, and measurements of areas of body treated; (d) Changes from previous objective findings; (e) Interpretation of results; (f) Goals met or not met and reasons; (g) Updated goals; (h) Updated plan of care including recommendations for follow-up; and (i) Signature, title (PT), and license number; (4) Discharge, by including the following information in the discharge summary, which may be combined with the final visit note, if seen by the physical therapist on the final visit and written by the physical therapist: (a) Date; (b) Reason for discharge; (c) Objective status; (d) Recommendations for follow-up; and (e) Signature, title (PT), and license number. B. Notwithstanding §A(4) of this regulation, a physical therapist may direct a physical therapist assistant to treat a patient on a final visit. C. The physical therapist assistant shall document the patient's chart each time the patient is seen by the physical therapist assistant following the physical therapist's initial evaluation or reevaluation by including the following: (1) Date; (2) Cancellations and no-shows; (3) Modalities, procedures, or both, including parameters involved, and areas of body treated; (4) Objective status; (5) Response to treatment, if any; (6) Continuation of plan as established by the physical therapist or change of plan as authorized by the physical therapist; and (7) Signature, title (PTA), and license number, although the flow chart may be initialed. D. Subsequent visits, as referred to in §A(2) of this regulation, in the same day by the same physical therapist do not require separate progress notes unless there is a change in the patient's status. E. Ongoing Communications. Both the physical therapist and the physical therapist assistant shall document ongoing communication between the physical therapist and physical therapist assistant regarding changes in a patient's status and treatment plan. #### Regulation .03 Penalties. *COMAR 10.38.03.03* Violation of these regulations may result in the Board taking action to reprimand a licensee, place a licensee on probation, or suspend or revoke a license. The Board may also impose a penalty not exceeding $5,000. ### Chapter 04 — Physical Therapy Aide **Authority:** Health Occupations Article, §13-206, Annotated Code of Maryland **Administrative History:** Effective date: November 8, 1982 (9:22 Md. R. 2197) **Administrative History:** Regulation .01 amended effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulation .01B amended effective November 1, 1999 (26:22 Md. R. 1693) **Administrative History:** Regulation .01 amended effective December 25, 2000 (27:25 Md. R. 2282) **Administrative History:** Regulation .02C adopted effective November 1, 1999 (26:22 Md. R. 1693) **Administrative History:** Regulation .03 amended effective November 1, 1999 (26:22 Md. R. 1693); December 25, 2000 (27:25 Md. R. 2282) #### Regulation .01 Definition. *COMAR 10.38.04.01* A. In these regulations, the following term has the meaning indicated. B. Term Defined. “Physical therapy aide” or “aide” means a person who performs certain physical therapy duties under the direct supervision of a licensed physical therapist. This individual may be known, also, as a physical therapy technician, a rehabilitation technician, an athletic trainer, or be described by some other similar title. #### Regulation .02 Requirements. *COMAR 10.38.04.02* A. Supervision. (1) The physical therapy aide shall be under the direct supervision of a licensed physical therapist when performing those physical therapy treatments that the aide is permitted to perform. (2) Exceptions. An aide may: (a) Perform non-treatment-related activities, such as secretarial, clerical, and housekeeping duties without direct supervision; (b) Perform patient-related activities that do not involve treatment (such as transporting patients, undressing and dressing patients, removing and applying assistive and supportive devices) without direct supervision; (c) Assist a physical therapist assistant when more than one individual is required to ensure the safety and welfare of the patient during ambulation, transfers, or functional activities without direct supervision. B. In-Service Training. There shall be documented evidence of sufficient in-service training to assure safe performance of the duties assigned to the aide. #### Regulation .03 Activities Which May Be Performed by Aides under Direct Supervision. *COMAR 10.38.04.03* The following activities may be performed by aides under direct supervision: A. Assist in the practice of gait and ambulation; B. Assist in the practice of functional activities; C. Assist in the practice of transfers; D. Assist in the routine follow-up of specific exercises; E. Assist in the application of hot or cold packs; F. Assist in the procedure of Hubbard tank; G. Assist in the procedure of whirlpool; H. Assist in the application of contrast bath; I. Assist in the application of infrared; and J. Assist in the application of paraffin bath. #### Regulation .04 Prohibited Activities. *COMAR 10.38.04.04* A. Evaluation may not be performed by aides. B. Treatments other than those listed in Regulation .03 of this chapter may not be performed by aides. #### Regulation .05 Penalty. *COMAR 10.38.04.05* A physical therapy aide who violates the above regulations shall be considered by the Board to be practicing physical therapy in violation of the Maryland Physical Therapy Practice Act and may be referred to the appropriate State's Attorney's Office with a recommendation by the Board that the physical therapy aide be prosecuted. ### Chapter 05 — Rules of Procedure for Board Hearings **Authority:** Health Occupations Article, §§13-206 and 13-317;State Government Article, §§10-205 and 10-206; Annotated Code of Maryland **Administrative History:** Effective date: November 8, 1982 (9:22 Md. R. 2197) **Administrative History:** Regulation .02A amended effective November 7, 1994 (21:22 Md. R. 1878) **Administrative History:** Regulation .02C amended effective July 12, 1999 (26:14 Md. R. 1083) **Administrative History:** Regulation .04 amended effective January 24, 2000 (27:1 Md. R. 77) **Administrative History:** Regulation .05 amended as an emergency provision effective January 1, 2001 (28:3 Md. R. 203); amended permanently effective April 16, 2001 (28:7 Md. R. 690) **Administrative History:** Regulation .05B, C amended effective November 7, 1994 (21:22 Md. R. 1878) **Administrative History:** Regulation .05-1 adopted effective March 18, 2002 (29:5 Md. R. 504) **Administrative History:** Regulations .01 — .08 repealed and new Regulations .019.0%); (5) Lead screening measures: (a) Lead screening measure for children 1223 months old; and (b) HEDIS lead screening in children; (6) HEDIS postpartum care; (7) HEDIS risk of continued opioid use >=31 days covered; and (8) HEDIS timeliness of prenatal care. C. Each measure identified in §B of this regulation shall be valued equally at a proportional share of available incentive funds, except for measures §B(5)(a) and (b), which are each valued at half of the available incentive funds relative to one of the other measures. D. There shall be two rounds of potential incentive payments an MCO may earn. E. Subject to budget approval, total PHIP funding shall be determined prior to the measurement year and included in the MCO contract. F. All PHIP payments shall be funded independently from and outside of MCO capitation payments during a given calendar year. G. Each MCO shall be eligible for no more than 1 percent of the plan's measurement year capitation payments, excluding supplemental payments outside of capitation, as total payment from round one and round two. H. If the Department determines that the score for any measure identified in §B of this regulation may not be comparable to the previous year's score due to alterations in measure specifications or other factors, the Department may exclude the measure from the PHIP and adjust the incentive valuation in accordance with the remaining performance measures. I. Round One Incentives. (1) An MCO may earn two types of incentives in round one: (a) A performance incentive payment; and (b) An improvement incentive payment. (2) If an MCO does not report a performance measure or an MCO has a performance score of 0 percent, then the MCO is awarded no performance or improvement incentive payments for this measure. (3) Performance Incentive Payments for Round One. (a) Performance incentive payments shall be based on the following categories for each performance measure: (i) Superlative performance, meaning the performance measure's score is at or above the 90th percentile of HEDIS Medicaid performance nationwide during the measurement year, or estimated 90th percentile among Maryland HealthChoice MCO performance for non-HEDIS performance measures; (ii) Very strong performance, meaning the performance measure's score is between the 75th and 89th percentiles, inclusive, of HEDIS Medicaid performance nationwide during the measurement year, or between the estimated 75th and 89th percentiles, inclusive, among Maryland HealthChoice MCO performance for non-HEDIS performance measures; or (iii) Strong performance, meaning the performance measure's score is between the 50th and 74th percentiles, inclusive, of HEDIS Medicaid performance nationwide during the measurement year, or between the estimated 50th and 74th percentiles, inclusive, among Maryland HealthChoice MCO performance for non-HEDIS performance measures. (b) Payments for round one performance incentives shall be allocated as follows: (i) For superlative performance, an MCO may earn 100 percent of the incentive allocation for the performance measure; (ii) For very strong performance, an MCO may earn 66.6 percent of the incentive allocation for the performance measure; (iii) For strong performance, an MCO may earn 33.3 percent of the incentive allocation for the performance measure; and (iv) Any MCO earning a performance measure score below the 50th percentile of HEDIS Medicaid performance nationwide during the measurement year on a HEDIS-based measure, or below the calculated 50th percentile among Maryland HealthChoice MCO performance for a non-HEDIS measure, shall be ineligible for a round one performance incentive payment. (4) Round One Improvement Incentive Payments. (a) An MCO may earn an improvement incentive payment of 33.3 percent of the incentive allocation for any performance measure if the following conditions are met: (i) The MCO demonstrates improvement of at least 0.5 percentage points in the measure compared to the previous measurement year; and (ii) The performance measure score is at or above the 50th percentile of HEDIS Medicaid performance nationwide on a HEDIS-based measure, or the 50th percentile of Maryland HealthChoice MCO performance for a non-HEDIS measure. (b) An MCO earning a superlative performance incentive payment for a performance measure is ineligible for an improvement incentive payment for the same measure. (c) For any performance measures in which a lower score indicates stronger performance, year-over-year improvement is demonstrated by a reduction in the score for that measure. (d) If an MCO is missing or zero-valued for a performance measure in the previous year, then no improvement incentive will be awarded in the measurement year. J. Round Two Incentive Payments. (1) An MCO may qualify for payments under round two if the following conditions are met: (a) The MCO earned above 80 percent of possible round one incentives; and (b) The MCO did not have penalties applied during the measurement year for failure to meet the HEDIS MCO Performance Monitoring Policy included in the MCO contract. (2) Any remaining funds that were unallocated during round one may be awarded to eligible MCOs in round two for a maximum incentive award of up to 1 percent of its total capitation payment during the PHIP measurement year, excluding supplemental payments outside of capitation. (3) If any remaining funds that were unallocated during round one are not sufficient to settle all qualifying MCOs up to 1 percent of capitation in round two, then the leftover funds will be awarded proportionally among qualifying MCOs based on enrollment. K. If additional funds remain after both round one and round two, the Department may, within its discretion, allocate the funding as follows: (1) Make additional payments to MCOs that are below 1 percent of capitation based on improvement or performance; or (2) Place remaining funds into a nonlapsing pool. L. Effective measurement year 2025, an MCO with penalties under the HEDIS MCO Performance Monitoring Policy included in the HealthChoice MCO Agreement shall be excluded from all rounds of PHIP for that measurement year. M. Incentives awarded under this regulation and exclusion from PHIP participation are not appealable under COMAR 10.67.10.. #### Regulation .04 Special Needs Populations. *COMAR 10.67.04.04* A. An MCO shall provide health care services to enrollees who are members of special needs populations. B. Special needs populations consist of the following non-mutually exclusive populations: (1) Children with special health care needs; (2) Individuals with a physical disability; (3) Individuals with a developmental disability; (4) Pregnant and postpartum women; (5) Individuals who are homeless; (6) Individuals with HIV/AIDS; and (7) Children in State-supervised care. C. General Requirements for Special Needs Populations. (1) An MCO shall demonstrate that its pediatric and adult primary care providers (PCPs) and specialists are clinically qualified based upon generally accepted community standards to provide or arrange for the provision of appropriate health care services to individuals who are members of a special needs population. The MCO shall submit to the Department referral protocols that demonstrate the conditions under which PCPs will make the arrangements for referrals to specialty care networks. (2) Clinical qualifications are to be determined through the MCO's credentialing and recredentialing processes, including a review of the provider's medical education, special training, and work history and experience. (3) Specialty and subspecialty providers shall: (a) Have experience in treating individuals within a special needs population; (b) Have experience in interdisciplinary medical management; and (c) Understand the relationship between somatic and behavioral health care issues and interventions. (4) The MCO shall demonstrate the use of a primary care system of care delivery which includes a comprehensive plan of care for an enrollee who is a member of a special needs population and which uses a coordinated and continuous case management approach, involving the enrollee and, as appropriate, the enrollee's family, guardian, or caregiver, in all aspects of care, including primary, acute, tertiary, and home care. (5) To meet the commitment outlined in §C(4) of this regulation, an MCO shall: (a) Provide case management services to adult and pediatric enrollees as appropriate; (b) Have the capacity to perform home visits as part of the ongoing case management program and have the ability to respond to urgent care needs while in the enrollee's home; (c) Ensure that, if warranted, a case manager is assigned to an enrollee at the time of the initial health screen by the MCO; (d) Ensure that the PCP, who may also be the specialist, shall be the admitting or referring provider for all hospital admissions; (e) Ensure that it will: (i) Collaborate with inpatient facilities in facilitating preadmission and discharge planning, and (ii) Communicate all post-discharge home and community arrangements to the enrollee, the PCP, and, as appropriate, the enrollee's family, guardian, and caregiver; (f) Document the plan of care and treatment modalities provided to enrollees in special populations, assuring that the plan of care: (i) Is updated at least annually, when the enrollee’s circumstances or needs change significantly, or at the enrollee’s request; and (ii) Involves the enrollee and, as appropriate, the enrollee's family, guardian, and caregiver in care decisions; and (g) Be familiar with community and social support providers for the special populations. (6) An MCO shall make documented outreach efforts to contact and educate enrollees who fail to appear for appointments or who have been noncompliant with a regimen of care. These efforts may include, but may not be limited to, notification: (a) By mail; (b) By telephone; (c) By email; (d) By text messaging; and (e) Through face-to-face contact. (7) Referral to Local Health Department. (a) An MCO shall make a written referral, or ensure that the enrollee's provider makes a written referral, to the local health department (LHD) for the county in which an enrollee resides, for assistance in bringing into care an enrollee for whom the MCO has been unsuccessful in its documented out-reach efforts pursuant to §C(6) of this regulation, within 10 business days of whichever first occurs: (i) The third consecutive missed appointment; or (ii) The MCO or the enrollee's provider identifies the enrollee's repeated noncompliance with a regimen of care. (b) The MCO may not include information about an enrollee's HIV status on the form used to refer an enrollee to the local health department. (8) An MCO shall subject its decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested, for an enrollee who is a member of special needs population to utilization review that includes review by a health care professional who has appropriate clinical expertise in treating the enrollee's condition or disease. (9) An MCO shall identify a special needs coordinator, who shall: (a) Serve as a point of contact for health care services information and referral for members of special needs populations; (b) Be skilled in communications with, and sensitive to the unique needs of, members of special needs populations, their families, guardians, and caregivers; (c) Participate on the MCO's consumer advisory board, pursuant to Regulation .12 of this chapter, as a representative of special needs populations; (d) Serve as a resource to MCO providers and enrollees on the requirements of P.L. 101-330, Americans with Disabilities Act of 1990, 42 U.S.C. §12101 et seq.; and (e) Maintain a log of each denial of treatment and the outcome of the utilization review conducted pursuant to §C(8) of this regulation. (10) An MCO shall have mechanisms in place to allow enrollees with special health care needs to access a specialist directly as appropriate for the enrollee’s condition and identified needs. #### Regulation .05 Special Needs Populations — Children with Special Health Care Needs. *COMAR 10.67.04.05* A. An MCO shall meet the standards set forth in this regulation for treating children with special health care needs. B. The Department shall maintain a record of the complaints received through the Department's enrollee and provider hotlines which involve the denial of care for children and review these complaint logs as part of its quality assurance system. C. An MCO shall demonstrate that its therapies provider network is adequate by demonstrating its: (1) Providers' pediatric specialties; (2) Collaboration with schools that provide IEP or IFSP services to its enrollees, where available; and (3) Provision of family-focused services and development of family-focused plans of care. D. An MCO shall provide case management services to children with special health care needs as appropriate. For complex cases involving multiple medical interventions or social services, or both, a multidisciplinary team shall be used to review and develop the plan of care for special health care needs children. E. An MCO shall provide coordinated care for special health care needs children in State-supervised care. F. An MCO shall refer child victims of alleged abuse, neglect, or sexual offense to an appropriate provider capable of: (1) Determining if the alleged abuse, neglect, or sexual offense occurred; (2) Determining if medical intervention is needed; and (3) Ensuring the preservation of evidence. G. An MCO shall ensure coordination with the Department’s Early and Periodic Screening, Diagnosis and Treatment (EPSDT) program. H. An MCO shall establish protocols for effecting medically necessary service referrals to specialty care providers for children with special health care needs. I. The service referrals referenced in §H of this regulation shall: (1) Include services intended to improve or preserve the continuing health and quality of life for children with special health care needs, regardless of the ability of the services to effect permanent cure; and (2) Be made when the child is: (a) Identified as being at risk of a developmental delay by the developmental screen required by EPSDT; (b) Experiencing a delay of 25 percent or more in any developmental area as measured by appropriate diagnostic instruments and procedures; (c) Manifesting atypical development or behavior; or (d) Diagnosed with a physical or mental condition that has a high probability of resulting in developmental delay. J. An MCO shall provide durable medical equipment to a special needs child in a timely manner. K. When a child, who is an MCO enrollee, is diagnosed with a special health care need requiring a plan of care which includes specialty services, and that health care need was undiagnosed at the time of enrollment, the parent or guardian of that child may request approval from the MCO for a specific out-of-network specialty provider to provide those services when the MCO does not have a local in-network specialty provider with the same professional training and expertise who is reasonably available and provides the same service and modality, subject to the following provisions: (1) If the MCO denies the request for an out-of-network provider referral, the child's parent or guardian may initiate the complaint and appeal process set forth at COMAR 10.67.09.05; (2) If at any time the MCO decides to terminate or reduce services provided by the approved out-of-network provider, the child's parent or guardian may initiate the complaint and appeal process set forth at COMAR 10.67.09.05; (3) The MCO shall continue to cover the services of the out-of-network provider during the course of the appeal until such time as the Office of Administrative Hearings issues its decision. #### Regulation .06 Special Needs Populations — Individuals with a Physical Disability. *COMAR 10.67.04.06* A. An MCO shall meet the standards set forth in this regulation for treating an individual with a physical disability. B. An MCO shall demonstrate that its providers for durable medical equipment and assistive technology provide the appropriate services and are clinically qualified to provide these services to the individual with a physical disability. C. Before placement of an individual with a physical disability into an intermediate or long-term care facility, an MCO shall: (1) Recommend that an individual with a physical disability be transferred to an intermediate or long-term care facility only after assessing the needs of the individual and the ability of the MCO to meet these needs in the community as supplemented by other Medicaid services; (2) Conduct a second opinion review of the case, performed by the MCO's medical director, before a transfer to an intermediate care facility or a long-term care facility is implemented; and (3) If the MCO's medical director determines that the transfer to an intermediate or long- term care facility is medically necessary and that the expected stay will be greater than 30 days, obtain approval from the Department before making the transfer. D. An MCO shall utilize individuals with expertise in disabilities to review its marketing and informational forms and publications, which shall be provided in alternative formats with reasonable accommodation to people with a physical disability. E. An MCO shall provide education for the MCO's member services staff, triage staff, and case managers on special communications requirements for individuals with physical disabilities. #### Regulation .07 Special Needs Populations — Individuals with a Developmental Disability. *COMAR 10.67.04.07* A. An MCO shall meet the standards set forth in this regulation for treating an individual with a developmental disability. B. An MCO shall ensure that its case managers have experience or training related to developmental disabilities. C. An MCO shall utilize individuals with expertise in disabilities to review its marketing and informational forms and publications, which shall be provided in alternative formats with reasonable accommodation to people with developmental disabilities. D. An MCO shall provide education for the MCO's member services staff, triage staff, and case managers on special communications requirements for individuals with developmental disabilities. #### Regulation .08 Special Needs Populations — Pregnant and Postpartum Women. *COMAR 10.67.04.08* A. An MCO shall meet the standards set forth in this regulation for treating pregnant and postpartum women. B. An MCO shall ensure access to prenatal care for pregnant women and postpartum care for postpartum women by: (1) Scheduling an appointment for the first prenatal visit and seeing the woman within 10 days of request; (2) Scheduling an appointment for a postpartum woman and seeing the woman within 10 days of request: (3) Arranging for an adequate network of providers including obstetricians, gynecologists, perinatologists, neonatologists, anesthesiologists, and advanced practice nurses who are capable of addressing complex maternal and infant health issues; and (4) Linking a pregnant woman with a pediatric provider before delivery. C. An MCO shall ensure that prenatal providers: (1) Complete a prenatal risk assessment, using an instrument approved by the Department, at the first prenatal visit; and (2) Within 10 days of completing the prenatal risk assessment, forward this instrument to the local health department in the jurisdiction in which the pregnant enrollee lives. D. The Department may not include questions about a woman's HIV infection status on the prenatal risk assessment instrument. E. An MCO shall refer pregnant and postpartum women with a substance use disorder to the behavioral health ASO for substance use treatment within 24 hours of request. F. An MCO shall refer pregnant and postpartum women, infants, and children younger than 5 years old to the WIC (Special Supplemental Nutrition Program for Women, Infants, and Children) Program, and shall provide to WIC necessary medical information to determine WIC nutritional eligibility. G. An MCO shall follow, at a minimum, the American College of Obstetricians and Gynecologists (ACOG) guidelines for pregnant and postpartum women. H. An MCO shall provide risk-related medical and nonmedical preventive treatment services, including nutrition counseling by licensed nutritionists or dietitians and smoking cessation education and treatment for pregnant and postpartum women. I. An MCO shall provide HIV counseling, including a risk assessment and information about possible transmission of HIV to the fetus. J. An MCO shall offer its pregnant and postpartum enrollees voluntary HIV counseling and testing following the requirements of COMAR 10.67.06. K. An MCO shall arrange for the appropriate emergency transfer of pregnant women, newborns, and infants to tertiary care centers. #### Regulation .09 Special Needs Populations — Homeless Individuals. *COMAR 10.67.04.09* An MCO's initial health screen shall attempt to identify homeless individuals and link them to the appropriate provider of services. #### Regulation .10 Special Needs Populations — Individuals with HIV/AIDS. *COMAR 10.67.04.10* A. An MCO shall meet the standards set forth in this regulation for treating individuals with HIV/AIDS. B. HIV/AIDS Specialist. (1) An MCO shall allow an enrollee with HIV/AIDS to choose an HIV/AIDS specialist for treatment and coordination of primary and specialty care. (2) To qualify as an HIV/AIDS specialist, a health care provider shall be board certified in the field of infectious diseases by a member board of the American Board of Medical Specialties or: (a) Hold a current, valid, unrevoked, and unsuspended Maryland license or certification as a: (i) Doctor of medicine; (ii) Doctor of osteopathy; (iii) Nurse practitioner; or (iv) Physician's assistant being supervised by a medical doctor; (b) Have provided direct, continuous, ongoing care for at least 20 patients with HIV over the past 2 years; and (c) Have completed one of the following requirements: (i) If a medical doctor, certified physician's assistant being supervised by a medical doctor, or doctor of osteopathy, at least 30 hours of HIV-related continuing medical education category I credits over the past 2 years; (ii) If a nurse practitioner, at least 30 hours of HIV-related continuing education units over the past 2 years; (iii) If a medical doctor, certified physician's assistant being supervised by a medical doctor, doctor of osteopathy, or a nurse practitioner, an accredited training program over the past year; or (iv) If a medical doctor, certified physician's assistant being supervised by a medical doctor, doctor of osteopathy, or a nurse practitioner, has completed the American Academy of HIV Medicine (AAHIVM) credentialing examination. C. AIDS Case Management Services. (1) An MCO shall ensure that an enrollee with HIV/AIDS receives case management services that: (a) Link the enrollee with the full range of available benefits; (b) Link the enrollee with any additional needed services including: (i) Mental health services; (ii) Substance abuse services; (iii) Medical services; (iv) Social services; (v) Financial services; (vi) Counseling services; (vii) Educational services; (viii) Housing services; and (ix) Other required support services; (c) Ensure timely and coordinated access to medically necessary levels of care that support continuity of care across the continuum of service providers; (d) Are performed by licensed physicians, physician assistants, advanced practice nurses, registered nurses, social workers, or other individuals who are appropriately trained, experienced, and supervised by a licensed practitioner; and (e) Include, but are not limited to: (i) Initial and ongoing assessment of the enrollee's needs and personal support systems, including the MCO offering an enrollee one face-to-face meeting during the initial assessment and documenting the enrollee's acceptance or declination of the face to face meeting; (ii) Development of a comprehensive, individualized service plan, using a multidisciplinary approach; (iii) Coordination of the services required to implement the plan; (iv) Periodic reevaluation and adaptation of the plan as necessary over the life of the enrollee; (v) Development of an outreach system for the enrollee and family by which the case manager and primary care provider track services received, clinical outcomes, and the need for additional follow-up; and (vi) Serving as an effective enrollee advocate to resolve differences between the enrollee and providers of care pertaining to the course or content of therapeutic interventions. (2) An enrollee diagnosed with HIV/AIDS shall be offered case management services by the MCO at any time after diagnosis. An enrollee who has previously refused these services may request case management from the MCO at any time. D. Diagnostic Evaluation Service (DES) Assessment. (1) An MCO shall offer a diagnostic evaluation service (DES) assessment annually and document the enrollee's acceptance or declination. (2) The DES shall consist of a comprehensive medical and psychosocial assessment. (3) A DES provider shall use assessment and care plan forms used by the Department for adult and pediatric assessments. (4) An individual shall select a DES provider from an approved list of sites, and may select a DES provider which is not part of the individual's MCO if so desired. (5) An MCO and other qualified institutions may become DES providers as provided in COMAR 10.09.32.03C. E. An individual with HIV/AIDS who has a substance use disorder shall be referred to the behavioral health ASO for substance abuse treatment within 24 hours of request. F. Clinical Trials. (1) An MCO may refer enrollees who are individuals with HIV/AIDS to facilities or organizations that can provide the enrollees' access to clinical trials. (2) An MCO shall provide enrollees with HIV/AIDS access to clinical trials in accordance with COMAR 10.67.06.26-1. #### Regulation .11 Special Needs Populations — Individuals in Need of Substance Abuse Treatment — Repealed *COMAR 10.67.04.11* #### Regulation .12 Consumer Advisory Board. *COMAR 10.67.04.12* A. An MCO shall establish a consumer advisory board to facilitate the receipt of input from enrollees. B. The consumer advisory board membership shall: (1) Consist of enrollees and enrollees' family members, guardians, or caregivers; and (2) Be comprised of no less than one third representation from the MCO’s special needs populations, or their representatives and the MCO’s special needs coordinator. C. The consumer advisory board shall meet at least 6 times a year. #### Regulation .13 Children in State-Supervised Care. *COMAR 10.67.04.13* A. An MCO shall provide or arrange to provide all Medicaid-covered services required to comply with State statutes and regulations mandating health and mental health services for children in State-supervised care. B. An MCO shall ensure the continuity and coordination of care, provided locally to the extent the services are available, to an enrollee who is a child in State-supervised care. C. An enrollee who is a child in State-supervised care who moves shall be disenrolled from the recipient's MCO and enrolled in an alternative MCO if the recipient's current MCO does not serve the geographic region to which the child has been relocated. D. An MCO shall expedite a change of providers within its provider panel upon the move of an enrollee who is a child in State-supervised care to a new geographic area served by the MCO. E. On request of the responsible State or local agency, a child in State-supervised care may be disenrolled from the current MCO and enrolled in an MCO serving the group facility in which the child resides, members of the foster care family, or other children in foster care placement with the child. F. Enrollee Self-Referral. An MCO shall permit the self-referral of a child in State-supervised care to an EPSDT certified provider for an initial examination, including a mental health screen, and shall pay for all portions of the examination except for the mental health screen, which shall be paid for by the Specialty Mental Health System. G. Coordination with Responsible Agency. An MCO shall appoint a liaison to coordinate services to a child in State-supervised care with the responsible State or local agencies. #### Regulation .14 Referral to Behavioral Health ASO. *COMAR 10.67.04.14* A. An MCO is responsible for providing medically necessary primary behavioral health services to their enrollees. B. An enrollee may self-refer to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80. C. If an enrollee’s primary care physician determines that primary behavioral health services are not sufficient to meet the enrollee’s needs, the primary care physician shall refer the enrollee to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80. D. If an MCO determines that primary behavioral health services are not sufficient to meet the enrollee’s needs, the MCO shall refer the enrollee to the behavioral health ASO for services described in COMAR 10.09.59 or 10.09.80. E. An MCO shall cooperate with the behavioral health ASO in developing referral procedures and protocols. #### Regulation .15 Data Collection and Reporting. *COMAR 10.67.04.15* A. An MCO shall notify the Department immediately when it has knowledge of an enrollee's death. B. Encounter Data. (1) An MCO shall submit encounter data reflecting 100 percent of provider-enrollee encounters, in CMS1500 and UB04 format or an alternative format previously approved by the Department. (2) An MCO may use alternative formats including: (a) ASC X12N 837 and NCPDP formats; and (b) ASC X12N 835 format, as appropriate. (3) An MCO shall submit encounter data that identifies the provider who delivers any items or services to enrollees at a frequency and level of detail to be specified by CMS and the Department, including, at a minimum: (a) Enrollee and provider identifying information; (b) Service, procedure, and diagnoses codes; (c) Allowed, paid, enrollee responsibility, and third-party liability amounts; and (d) Service, claims submission, adjudication, and payment dates. (4) An MCO shall report encounter data within 60 calendar days after receipt of the claim from the provider. (5) An MCO shall submit encounter data utilizing a secure on-line data transfer system. C. Monthly Reports. (1) An MCO shall provide an updated list of the PCP's assigned enrollees to each PCP at least on a monthly basis. (2) An MCO shall participate in the electronic enrollment reconciliation process to identify discrepancies in enrollment data between the Department and the MCO. D. Quarterly Reports. An MCO shall submit to the Department: (1) Within 30 calendar days of the close of each calendar quarter, quality assurance reports including, but not limited to: (a) Quality assurance committee meeting minutes reflecting major quality assurance corrective action plans, initiatives, and activities; and (b) An analysis of recipient appeal and grievance logs including significant trends or anomalies, what caused the trend or anomaly, and any actions taken to address the trend or anomaly; (2) Within 30 calendar days after the close of each calendar quarter, in the format specified by the Department, a list of all pre-service denials or reduction of services or benefits issued by the MCO or MCO subcontractors during the preceding quarter. (3) Within 30 calendar days of the close of each calendar quarter, third-party liability collection activities as described in Regulation .18D of this chapter. (4) In a format specified by the Department, amounts the MCO has cost-avoided and recovered and the number of cases the MCO has handled in each case area during the quarter. (5) Not later than 45 days after the end of each quarterly rebate period, drug utilization data necessary for the Department to bill manufacturers for rebates in accordance with §1927(b)(1)(A) of the Social Security Act, that: (a) Include, at a minimum, the following information by National Drug Code of each covered outpatient drug dispensed or covered by the MCO: (i) Total number of units of each dosage form; (ii) Total number of units of each dosage strength; and (iii) Total number of units of each dosage package size; and (b) Distinguish utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program. (6) Within 10 calendar days after the close of each calendar quarter, in the format specified by the Department, a list of all State fair hearing outcomes during the preceding quarter. E. Annual Reports. Except as provided in §E(5) of this regulation, an MCO shall submit to the Department annually, within 90 days after the end of the calendar year: (1) A summary of the information contained in §D(1)(b) of this regulation; (2) A report of the MCO's consumer advisory board outlining the board's activities and recommendations; (3) A copy of the MCO's drug formulary; (4) Any revisions to the MCOs quality assurance, utilization management, and case management plans; (5) HealthChoice Financial Monitoring Reports (HFMRs), including any supplemental schedules required by the Department: (a) In the format required by the Department; (b) Prepared according to: (i) The criteria, set forth in Regulation .19-5 of this chapter, for allocating MCO costs to HFMR expense categories; and (ii) Reporting instructions provided by the Department for the HFMR form and any required supplemental schedules; and (c) Submitted according to the following schedule: (i) Services incurred from January 1 through December 31 of the prior year, reported through March 31 of the current year — due on May 15 of the current year; and (ii) Services incurred January 1 through December 31 of the prior year, reported through June 30 of the current year — due on September 1 of the current year; and (6) A detailed description of its drug utilization program activities. F. Unless the MCO is exempt for good cause, an MCO shall submit to the Department when requested the following reports for its enrollee/member services and provider/authorization/preauthorization lines: (1) Caller abandonment rates; (2) Caller service level rates; and (3) Caller average hold time. G. If the MCO exits the HealthChoice Program for any reason, including those listed in COMAR 10.67.02.06A(1)(e) and (f): (1) The MCO shall provide the Department with a list of enrollees and the name of each enrollee's PCP, at least 30 days before exiting the program; and (2) On receiving the list provided by the MCO, the Department shall provide the list to: (a) The health benefits exchange to assist and provide outreach to participants in selecting an MCO; and (b) If permitted by State and federal law, the remaining MCOs for linking participants with a PCP. H. Jurisdictional Reporting to Local Health Departments. The Department shall: (1) Aggregate by jurisdiction the encounter data it receives from MCOs; and (2) Provide to local health departments jurisdiction-specific information based on aggregated encounter data for public health monitoring and assessment. I. For the purposes of Maryland Medicaid Managed Care Program administration or monitoring MCO performance pursuant to this chapter, the MCO shall supply other information as the Department may from time to time request, given a reasonable period of notice. J. Nonfederally qualified MCOs shall report a description of certain transactions with parties of interest, as described in §1903(m)(4)(A) of the Social Security Act. K. Upon request, an MCO whose member has disenrolled shall transfer historical utilization data to the member's new MCO in the time frame and format specified by the Department. #### Regulation .16 Repealed. *COMAR 10.67.04.16* #### Regulation .17 Subcontractual Relationships. *COMAR 10.67.04.17* A. Subcontracting Permitted. (1) Consistent with this regulation, an MCO may subcontract services that it is required to provide to its enrollees under COMAR 10.67.06 to a health care provider that is licensed, certified, or otherwise legally authorized to provide those services. (2) An MCO may not discriminate for the participation, reimbursement, or indemnification of any provider who is acting within the scope of the provider's license or certification under applicable State law, solely on the basis of that license or certification. (3) An MCO shall have written agreements with subcontractors that comply with 42 CFR §§438.214 and 455.105, as amended, and include at least the following: (a) A provision that the subcontractor be subject to all of the requirements to which the MCO is subject under its contract with the Department and pursuant to the Department's regulations; (b) A clear description of the services to be performed under the subcontract sufficient to definitively inform the Department which of the MCO's obligations have been subcontracted; (c) A provision for the subcontractor's release to the MCO and to the Department, upon request, of any information necessary for the MCO to perform any of its contractual and regulatory obligations under its contract with the Department, including, but not limited to, its records, reporting, and quality assurance duties; (d) A provision requiring that the subcontractor complies with all State and federal requirements regarding audit, inspection, and evaluation; (e) A provision that copies of the subcontractor's medical records pertaining to the MCO's enrollees shall be furnished to the MCO upon request for transfer to a subsequent provider in the event of a termination of the subcontract; (f) A provision to the effect that no termination of the subcontract shall be effective without prior written notice to the Department; (g) An agreement that the subcontractor will look solely to the MCO for compensation for covered services provided to the MCO's enrollees under the subcontract; (h) An assurance that evidence of the subcontractor's professional liability coverage will be submitted annually to the MCO; (i) A provision that no assignment of the subcontract by the subcontractor is effective without prior written notice to the Department; (j) If the subcontractor is authorized by the MCO to make referrals, a provision requiring the subcontractor to use the uniform consultation referral form adopted by the Maryland Insurance Administration at COMAR 31.10.12.06; (k) A provision to the effect that each provision of the subcontract that is required under this section supersede and be controlling over any conflicting terms that appear in the subcontract; (l) A provision for revocation of the delegation of activities or obligations, or specifying other remedies in instances where the Department or the MCO determines that the subcontractor has not performed satisfactorily; (m) A provision stating that the MCO has the right to audit the subcontractor pursuant to 42 CFR §438.230(c)(3)(i) for 10 years from the final date of the contract period or from the date of completion of any audit, whichever is later; and (n) A provision to the effect that all providers and subcontractors are subject to a grievance and appeal system consistent with the requirements of COMAR 10.67.09. (4) An MCO may not subcontract for hospital services with a hospital or an entity related to a hospital unless that hospital is in compliance with COMAR 10.37.12 (fixed price contracting regulations). (5) An MCO may not prohibit or otherwise restrict a health care professional, acting within the lawful scope of practice, from advising or advocating on behalf of an enrollee who is the provider's patient for: (a) The enrollee's health status, medical care, or treatment options, including any alternative treatment that may be self-administered; (b) Any information the enrollee needs in order to decide among all relevant treatment options; (c) The risks, benefits, and consequences of treatment or nontreatment; or (d) The enrollee's right to participate in decisions regarding the enrollee's own health care, including the right to refuse treatment, and to express preferences about future treatment decisions. B. Subcontractual Relations Reporting Requirements. (1) An MCO shall submit its standard subcontract to the Department for its approval at least 30 days in advance of the MCO entering into any subcontracts covered by this regulation. (2) An MCO shall submit to the Department for its prior approval material modifications to, or deviations from, its approved standard subcontract. (3) An MCO shall submit to the Department a specification of procedures to be followed when reallocating responsibility in the event of a change in obligations in its approved standard subcontract. (4) Network Provider Termination. (a) When an MCO and provider terminate their contract the MCO shall provide the Department with a written notice regarding the termination. (b) If the MCO is terminating the contract, the notice required in §B(4)(a) of this regulation shall be provided at the later of: (i) 30 calendar days before the effective date of the termination; or (ii) 15 calendar days after receipt or issuance of the termination notice. (c) If the provider is terminating the contract, the notice required in §B(4)(a) of this regulation shall be provided within 15 days after the MCO receives the notice from the terminating provider. (d) If 50 to 99 enrollees are affected, the notice shall contain the: (i) Date of termination; (ii) Name or names of providers or subcontractors terminating; (iii) Number of enrollees affected; and (iv) MCO's plan for transitioning enrollees to other providers. (e) If more than 99 enrollees are affected, the MCO shall provide the Department with a Department-approved termination survey. (f) In determining the number of enrollees affected under §B(4)(d) and (e) of this regulation, the MCO shall consider: (i) For PCPs, the number of enrollees assigned to the PCP; and (ii) For all other providers, the number of enrollees who are in active treatment or who have had an encounter with the provider in the previous 12 months. (5) Subcontractor Termination. (a) When an MCO terminates a subcontract impacting its operations, covered services, or enrollees, the MCO shall provide the Department with written notice regarding the termination that describes: (i) The dollar amount of the subcontract; (ii) The effect of the termination on MCO operations; (iii) The effect of the termination on MCO covered services or enrollees; and (iv) The MCO’s plan to replace the subcontractor, if applicable. (b) If the termination of the subcontract impacts MCO operations, the notice required in §B(5)(a) of this regulation shall be provided at least 90 days before the effective date of the termination. C. By entering into a subcontract to provide health care services on behalf of an MCO, the subcontractor becomes subject to all the requirements concerning audits and inspections by the Department and other government agencies that are imposed upon the MCO by statute or regulation, or by its contract with the Department. D. An MCO shall monitor the performance of its subcontractors, including, but not limited to, the areas of enrollee and provider complaints, access issues, quality assurance activities, record keeping, and reporting requirements. E. An MCO shall report to the Department any material deviations from required procedures by its subcontractor which, in the MCO's judgment, can be expected to have a significant effect on quality of care, or on enrollees' ability to access care. #### Regulation .18 Third-Party Liability. *COMAR 10.67.04.18* A. An MCO is responsible for the identification of, and collection of, moneys owing from responsible third parties liable for the cost of medical care furnished by the MCO to enrollees. B. Upon request from the Department or the U.S. Department of Health and Human Services, an MCO shall convey any information regarding third-party liability to the Department, to the U.S. Department of Health and Human Services, or to another MCO. C. The Department shall notify an MCO of any third-party liability identified during the course of eligibility determination. D. The MCO shall submit to the Department any new or changed third-party information in an automated format on a monthly basis. E. The Department shall provide the MCOs with any new or changed information on a monthly basis in an automated format. F. In order to facilitate the Department's and the U.S. Department of Health and Human Services' monitoring of its third-party liability collection activities, an MCO shall: (1) Submit to the Department, on a monthly basis, reports on third-party collections and activities during the month, including but not limited to amounts the MCO has cost-avoided and recovered and current accounts receivable for all third-party liability cases; (2) Submit to the Department, on a quarterly basis and in a format specified by the Department, amounts the MCO has cost-avoided and recovered and the number of cases the MCO has handled in each case area during the quarter; (3) Cooperate in site inspections by either the Department or the U.S. Department of Health and Human Services for monitoring purposes; and (4) Submit a detailed report of third-party liability collection activities including, but not limited to, cost avoidance, recovered amounts, and current amounts receivable for cases selected by the Department. G. When both the Department and an MCO have a right of subrogation, they shall coordinate settlement negotiation, ensuring that the funds available are prorated to allow sufficient compensation to settle each party's claim amount. H. For insurance coverage identified by an MCO with a retroactive effective date, an MCO shall comply with Insurance Article, §15-1008, Annotated Code of Maryland. I. An MCO may not deny a provider’s request for a preauthorization solely because a recipient has, or is thought to have, third-party insurance. J. The requirement in §I of this regulation may not apply if an MCO has a process in place to ensure that a claim will not be denied for lack of preauthorization if the claim ultimately becomes the MCOs responsibility for one of the following reasons: (1) The recipient does not have third-party insurance; or (2) The service received is a noncovered service under the third-party insurance. K. If an MCO identifies another party as being responsible for retroactive denial of reimbursement, the MCO shall: (1) Obtain a written statement from the third-party that includes: (a) The name and address of the third party; and (b) Acknowledgment of responsibility for payment of the denied claim by the third party; (2) Send this written statement to the provider seeking reimbursement; and (3) Provide this written statement or a summary report to the Department upon request. #### Regulation .18-1 MCO Reimbursement — GME Exclusion. *COMAR 10.67.04.18-1* A. Capitation Rate Setting Methodology — Extraction of Graduate Medical Education Costs. (1) Percentage of Teaching Hospitals' Rates Representing GME Costs. The Department, in consultation with the HSCRC, shall: (a) Determine the amount, expressed as a percentage, of payments by the Program that are attributable to GME, based on historic cost and discharge abstract data that: (i) Are specific to each individual teaching hospital; (ii) Are specific to Program recipients who would have been MCO-eligible if COMAR 10.67.01—.12 had been in effect at the time the activity reflected in the data occurred; (iii) Reflect services that would be, if performed during the contract year to which calculations utilizing a teaching hospital's GME percentage amount relate, included in the mandatory MCO benefits package described in COMAR 10.67.06; and (iv) Represent activity in FY 1995; and (b) For any teaching hospital that is not in compliance with the primary care and innovation requirements of COMAR 10.10.67.11, reduce the Program's payments to the hospital deemed to be attributable to GME pursuant to §A(1)(a) of this regulation by the hospital's noncompliance penalty percentage derived in accordance with COMAR 10.67.11.03C. (2) GME Percentage Start-Up Adjustment. To ameliorate the impact on MCOs that historically have experienced low utilization of teaching hospitals, the Department shall, during the first 3 years of separate GME funding, reduce the GME percentage determined in accordance with §A(1) of this regulation in the following amounts: (a) FY 1999 ... 10 percent; (b) FY 2000 ... 6.7 percent; (c) FY 2001 ... 3.3 percent; and (d) FY 2002 and thereafter ... 0 percent. (3) Modifying GME Percentage to Maintain Budget Neutrality. (a) To maintain budget neutrality in the GME funding procedure established pursuant to this regulation and COMAR 10.67.11, the Department may modify the GME percentages established pursuant to §A(1) and (2) of this regulation. (b) The Department may use the modified GME percentage authorized by §A(3)(a) of this regulation to calculate non-GME teaching hospital costs pursuant to §A(4) of this regulation, for the purpose of equalizing: (i) The amount of GME costs to be excluded from capitation rates for the contract year pursuant to §A(4) of this regulation; and (ii) The amount of GME allocation payments, determined pursuant to COMAR 10.67.11.03C. (c) Application of the GME percentage modification authorized in §A(3)(a) and (b) of this regulation does not affect the amount of the GME allocation payments made pursuant to COMAR 10.67.11.03C. (4) GME Adjustment in Capitation Rate-Setting Methodology. (a) Before determining the average historic costs assigned to the rate cells set forth in Regulation .19B of this chapter, the Department shall, consistent with §A(1)—(3) of this regulation, deduct, for each rate cell, the dollar amount allocatable to GME contained in the Department's base year payments to teaching hospitals. (b) The deduction referenced in §A(4)(a) of this regulation is calculated as follows: (i) For each payment included in the base year data made by the Program to a teaching hospital in the contract year, the amount of the payment is multiplied by the hospital-specific GME percentage, established pursuant to §A(1)—(3) of this regulation; and (ii) The dollar amount attributable to GME that is included in the base year payments, as identified by the procedure described in §A(4)(b)(i) of this regulation, is subtracted from the total amount of the payment to yield the non-GME portion of the payment. (5) Consistent with §A(4) of this regulation, the Department shall use the GME percentage rates calculated pursuant to §A(1)—(3) of this regulation for purposes of: (a) Calculating each teaching hospital's GME allocation payment amounts pursuant to COMAR 10.67.11.03C; (b) Determining the amount of each ACG's average non-GME historic costs for grouping ACGs to make risk adjustment category assignments of the ACGs pursuant to Regulation .19B of this chapter; (c) Determining the amount of each demographic grouping's average non-GME historic costs; and (d) Determining, for each risk adjustment category and demographic grouping, the capitation rates set forth in Regulation .19B of this chapter. B. The Department shall use, in calculating the capitation rates set forth in Regulation .19B of this chapter, a capitation rate-setting methodology that: (1) Excludes the dollar amount allocatable to GME, consistent with the percentage of GME included in historic payments made by the Program to teaching hospitals that receive GME allocation payments in the contract year, based on calculations that: (a) Are consistent with §A of this regulation; (b) Reflect any modifications made pursuant to §A(2) and (3) of this regulation to the percentage of the Program's historic payments made to teaching hospitals allocable to GME; and (c) Reflect the reduction of hospital-specific GME percentages, by operation of COMAR 10.67.11.03C and §A(1)(b) of this regulation, to decrease the amount of GME allocation payments made, pursuant to COMAR 10.67.11.03B, to teaching hospitals that are not in compliance with the primary care and innovation requirements of COMAR 10.67.11; (2) Reduces historic costs to reflect savings expected to result from a managed care delivery system; (3) Includes a trend factor to account for cost differences between the base year and the contract year; (4) Excludes the dollar amount of historic payments determined, based on an aggregation of individual inpatients' payment data for the base year, to be avoidable by an MCO pursuant to Regulation .22 of this chapter, had the services been furnished during the contract year; and (5) Beginning in FY 2000, takes into account Maryland Medicaid Managed Care Program enrollment of the newly eligible population entering the Program pursuant to the Maryland Children's Health Program. #### Regulation .19 MCO Reimbursement. *COMAR 10.67.04.19* A. Generally. (1) Payment to an MCO for each enrollee shall be at a fixed capitation rate, as specified in §B(4) of this regulation. (2) An MCO shall be reimbursed at rates set forth in this regulation only for individuals enrolled under the Maryland Medicaid Managed Care Program. (3) The capitation rate paid to an MCO by the Department shall be accepted as payment in full for all benefits provided by the MCO. (4) An MCO shall conform to the Department's computer coding requirements. (5) A capitation payment may not be made to an MCO on behalf of an enrollee for whom capitation payment for the same period has been made to any other MCO having an agreement with the Department. (6) The Department may consider a retroactive capitation payment to an MCO, if the MCO notifies the Department within 9 months of the first missed capitation payment for an enrollee for whom the MCO has not received all appropriate capitation payments. (7) Monies collected by an MCO for third party liability, as described in Regulation .18 of this chapter, are considered when calculating the capitation payments in §B(4) of this regulation. B. Capitation Rate-Setting Methodology. (1) Families and Children. Capitation rates for enrollees who are waiver-eligible based upon receipt of benefits through TCA or programs for medically needy families and children, including SOBRA children and Maryland Children's Health Program (MCHP), shall be established as follows: (a) For enrollees eligible under COMAR 10.67.02.01A(1) or (3), and for children eligible under COMAR 10.67.02.01A(2) for whom the Department has sufficient clinical data, the Department shall: (i) Determine an adjusted clinical group (ACG) assignment utilizing an enrollee's past diagnostic record; (ii) Utilizing aggregated enrollee ACG data, on an annual basis define a limited number of risk adjustment categories that reflect levels of relatively homogenous resource utilization by ACG assignment; and (iii) Assign an enrollee to a risk adjustment category based upon the enrollee's ACG assignment; (b) Except as provided in §B(1)(c) of this regulation, for enrollees for whom the Department has insufficient data to generate an ACG assignment, the Department shall assign the enrollee to a risk adjustment category that reflects the enrollee's: (i) Age, residence, and gender; and (ii) Birth weight with respect to an enrollee born after December 31, 2004; and (c) On the basis of the enrollee's residence, the Department shall assign: (i) All SOBRA mothers enrolled pursuant to COMAR 10.67.02.01A(2) to one of the two “SOBRA mother” payment categories set forth in §B(4)(a) of this regulation; and (ii) Enrollees with HIV to one of the two HIV payment categories set forth in §B(4)(a) of this regulation. (2) Disabled. Capitation rates for enrollees who are waiver-eligible based upon receipt of benefits through SSI or as medically needy, aged, blind, or disabled shall be established as follows: (a) Except as provided in §B(2)(c) of this regulation, for enrollees for whom the Department has sufficient clinical data, the Department shall: (i) Determine an adjusted clinical group (ACG) assignment utilizing an enrollee's diagnostic record; (ii) Utilizing aggregated enrollee ACG data, on an annual basis define a limited number of risk adjustment categories that reflect levels of nearly homogenous resource utilization by ACG assignment; and (iii) Assign an enrollee to a risk adjustment category (RAC) based upon the enrollee's ACG assignment; and (b) Except as provided in §B(2)(c) of this regulation, for enrollees for whom the Department has insufficient data to generate an ACG assignment, the Department shall assign the enrollee to a risk adjustment category that reflects the enrollee's age, residence, and gender; and (c) On the basis of the enrollee's residence, the Department shall assign: (i) Enrollees with HIV to one of the two HIV payment categories set forth in §B(4)(b) of this regulation; and (ii) Enrollees with AIDS to one of the two AIDS payment categories set forth in §B(4)(b) of this regulation. (3) Supplemental Delivery/Newborn Payments. (a) In addition to the monthly payment specified in §B(4)(a) or (b) of this regulation for an enrollee's payment category, the Department shall pay an MCO one supplemental payment per pregnancy in the amount specified in §B(4)(c) of this regulation, upon delivery of one or more infants without regard to method, timing, or place of delivery. (b) An MCO shall have 12 months from the date of delivery to bill for the supplemental payment. (4) Except to the extent of adjustments required by §D of this regulation or by Regulations .19-1 through 19-3 of this chapter, the Department shall make payments monthly at the rates specified in the following tables: (a) Rate Table for Families and Children Effective January 1, 2020—December 31, 2020. (b) Rate Table for Disabled Individuals Effective January 1, 2020— December 31, 2020. (c) Rate Table for Supplemental Payments for Delivery/Newborn and Hepatitis C Therapy Effective January 1, 2020 December 31, 2020. (d) Rate Table for Childless Adult Population Effective January 1, 2020—December 31, 2020. (e) Rate Table for Families and Children Effective January 1, 2021—December 31, 2021. (f) Rate Table for Disabled Individuals Effective January 1, 2021—December 31, 2021. (g) Rate Table for Supplemental Payments for Delivery/Newborn and Hepatitis C Therapy Effective January 1, 2021—December 31, 2021. (h) Rate Table for Childless Adult Population Effective January 1, 2021—December 31, 2021. (i) Interpretation of Rate Table for Families and Children. The table found at §B(4)(a) of this regulation shows capitation rates for individuals who are: (i) Waiver eligible based on receipt of benefits through TCA or programs for medically needy families and children; (ii) SOBRA children; (iii) SOBRA mothers; and (iv) The Maryland Children's Health Program. (j) Interpretation of Rate Table for Disabled Individuals. The table found at §B(4)(b) of this regulation shows the capitation rates for individuals who are waiver-eligible based upon receipt of benefits through SSI or as medically needy, aged, blind, or disabled. (k) Interpretation of Rate Table for Supplemental Payment for Delivery/Newborn. The table found at §B(4)(c) of this regulation shows a supplemental payment made in connection with deliveries of MCO enrollees, regardless of the enrollee's payment category under COMAR 10.67.04.19B(4)(a) or (b). (l) Interpretation of Rate Tables in §B(4) of this regulation. “PMPM” means the per member per month payment rate. (5) Consistent with the terms set forth in Regulation .19-4 of this chapter, the Department may, in consultation with the Commissioner, adjust the capitation payment of an MCO if it determines that the MCO's loss ratio, not including any rebate received by the MCO is less than 85 percent. C. The Department shall reimburse fee-for-service: (1) The Departmental share for any enrollee participating in the Stop Loss Program pursuant to Regulation .22 of this chapter; and (2) The cost of those services specified in COMAR 10.09.69.06.13 provided to the participant that have been authorized by the participant's case manager in accordance with the participant's plan of care. D. Interim Rates Adjustments. (1) Under the circumstances described in §D(2) and (3) of this regulation, the Department shall adjust the capitation rates set forth in §B(4)(a), (b), (e), and (f) of this regulation to reflect changes in service costs during the contract year due to an occurrence listed in §D(2) of this regulation. (2) The Department shall adjust the payment rates specified in §B(4)(a)(h) of this regulation to reflect service cost changes that qualify under §D(3) of this regulation and result from: (a) An addition or deletion of services covered under the HealthChoice benefits package; (b) An increase or decrease in Medicaid fee-for-service payment rates or copayments, if the MCOs are obligated to adjust their payment rates to providers as a result of those fee-for-service rate changes; (c) An increase or decrease in the inpatient charge per case as calculated by the change in the restated unit cost provided annually by the HSCRC as compared to the data originally provided; or (d) An increase or decrease in the outpatient charge per visit as calculated by the change in the restated unit cost provided annually by the HSCRC as compared to the data originally provided. (3) The Department shall make an interim rates adjustment if the effect of an occurrence listed in §D(2) of this regulation is sufficient to result in program-wide overpayment or underpayment of at least 0.2 percent because of the difference between: (a) Service cost projections used to develop the rates set forth in §B(4)(a), (b), (e), and (f) of this regulation; and (b) Service costs for the same period, taking into account an occurrence that is listed in §D(2) of this regulation. (4) The Department shall make any interim rate adjustments required by this section in amounts that are proportionate to the overpayments or underpayments described in §D(3) of this regulation. (5) Provider rate adjustments as specified in §D(2)(b) of this regulation may not require the MCOs to pay providers more than the Medicaid fee-for-service rate. (6) The Department shall make supplemental payments to an MCO that reflect increases in MCO provider payments for trauma services described in COMAR 10.25.10. (7) The Department shall make an interim rates adjustment in Calendar Years 2022, 2023, 2024, and 2025 to account for changes in acuity due to alterations in redetermination and enrollment processes related to COVID-19. E. Interim Rate Adjustment for Calendar Year 2025. (1) The Department shall re-open the capitation rates for interim rate adjustments in Calendar Year 2025 to revisit the following adjustments: (a) Risk adjustment; (b) Trend; (c) Administration; (d) Regional factors; and (e) Relational modeling. (2) To assist with the assessment, MCOs shall provide additional information to the Department upon request, including detailed claims data as well as a year-to-date HealthChoice Financial Monitoring Report for the calendar year. #### Regulation .19-1 MCO-Specific Case Mix Adjustment for HIV and AIDS with Hepatitis C. *COMAR 10.67.04.19-1* A. To reflect the higher level of risk associated with providing covered health care services pursuant to COMAR 10.67.06 to HIV/AIDS enrollees who also have Hepatitis C, the Department shall, to the extent provided by this regulation, make MCO-specific adjustments to payments for enrollees in HIV and AIDS payment categories to reflect the proportion of an MCO's HIV/AIDS enrollees who also have Hepatitis C. B. Identification of HIV/AIDS Enrollees with Hepatitis C. (1) For each MCO, the Department shall consider historical encounter and fee-for-service data for enrollees assigned to HIV and AIDS payment categories: (a) For the initial assessment period, as of June of the calendar year before the rate year; and (b) For the mid-year assessment period, as of December of the calendar year before the rate year. (2) For each MCO, the Department shall determine which of the HIV/AIDS enrollees meeting the criteria set forth in §B(1) of this regulation also have Hepatitis C. (3) The Department shall use encounter and fee-for-service data documenting services provided to the HIV/AIDS enrollees identified in accordance with §B(1) of this regulation for the appropriate historical diagnostic period: (a) For the initial assessment period, through June of the calendar year before the rate year; and (b) For the mid-year assessment period, through December of the calendar year before the rate year. C. Methodology for Determining MCO-specific HIV and AIDS Case Mix Measures. For each MCO, the Department shall: (1) Based on encounter and fee-for-service data from the appropriate historical diagnostic period, classify the MCO's HIV/AIDS enrollees identified pursuant to §B of this regulation as either: (a) Hepatitis C-infected; or (b) Hepatitis C-uninfected. (2) Average relative value for HIV and AIDS payment categories are as follows: (a) Apply weights reflecting costs associated with Hepatitis C-infected and Hepatitis C-uninfected enrollees in each HIV and AIDS payment category to the MCO-specific distribution of HIV/AIDS enrollees who are Hepatitis C-infected or Hepatitis C-uninfected, as determined pursuant to §C(1) of this regulation; and (b) For each MCO, use the results of the calculations specified in §C(2)(a) of this regulation to separately calculate an average relative value for each of the HIV and AIDS payment categories. (3) To determine an MCO's relative case mix factors, each MCO's relative values determined pursuant to §C(2)(b) of this regulation are divided by the overall average relative value determined pursuant to §C(2)(a) of this regulation. D. Methodology for MCO-Specific Case Mix-Adjusted HIV and AIDS Rates. For each MCO, the Department shall: (1) Calculate MCO-specific HIV and AIDS relative case mix factors for each HIV and AIDS payment group pursuant to §C(3) of this regulation; (2) Calculate MCO-specific HIV and AIDS rates for the rate adjustment period by multiplying the risk adjustment factor derived pursuant to §D(1) of this regulation by the value specified for each HIV and AIDS payment group for the rate year; and (3) Apply a budget neutrality adjustment to the values derived pursuant to §D(2) of this regulation so that the aggregate of payments to all MCOs pursuant to this regulation are equivalent to the aggregate of all payments that would be due to all MCOs in the absence of this regulation. E. Case Mix Updates. The Department shall: (1) Update current enrollees' region of residence and enrollment categories by repeating the calculations in §§B—D of this regulation every 6 months using residence and enrollment data as of the enrollment month specified below: (a) For the initial assessment period of each rate year, June of the calendar year before the rate year; and (b) For the mid-year assessment period of each rate year, December of the calendar year before the rate year; and (2) For rate adjustment periods beginning January 1 and July 1 of each rate year, use each MCO's updated Hepatitis C-infected and Hepatitis C-uninfected distribution to compute its risk adjusted HIV and AIDS payment rates for each rate adjustment period, as described in §D of this regulation. #### Regulation .19-2 MCO Supplemental Payment for Transitional Encounter Data Adjustment. *COMAR 10.67.04.19-2* A. The Department may grant an adjustment to those MCOs for whom the uniform encounter data adjustment results in completeness factors that are below the Statewide average. B. The encounter adjustment for each MCO shall be determined for the Family and Children RACs and for the Disabled RACs respectively. #### Regulation .19-3 MCO-Specific Case Mix Adjustment. *COMAR 10.67.04.19-3* A. Definitions. (1) In this regulation, in addition to the definitions set forth in COMAR 10.67.01, the following terms have the meanings indicated. (2) Terms Defined. (a) “Demographic rate cell” means a cell in one of the rates tables in Regulation .19B(4) of this chapter to which an MCO's enrollees are assigned pursuant to Regulation .19B(1)(b) and B(2)(b) of this chapter. (b) “Initial rate adjustment period” means the 6-month period beginning January 1 of the rate year. (c) “Mid-year rate adjustment period” means the 6-month period beginning July 1 of the rate year. (d) “RAC rate cell” means a cell in one of the rates tables in Regulation .19B(4) of this chapter to which an MCO's enrollees are assigned pursuant to Regulation .19B(1)(a) and (2)(a) of this chapter. (e) “Rate adjustment period” means a 6-month period within the rate year that includes: (i) The initial rate adjustment period beginning January 1 of the rate year; and (ii) The mid-year rate adjustment period beginning July 1 of the rate year. (f) “Rate year” means the calendar year to which the rates calculated pursuant to this regulation apply. (g) “Risk Adjustment Category (RAC)” means a grouping of adjusted clinical groups (ACGs), each of which is associated with a similar level of risk. (h) “Risk assessment cohort” means each of the eight groupings of enrollees, assigned on the basis of their: (i) Program eligibility category, either “families and children”, as specified in Regulation .19B(1) of this chapter, or “disabled”, as specified in Regulation .19B(2) of this chapter; (ii) Region of residence category, either in “Baltimore City” or in the “rest of State”; and (iii) Age category, either at least 1 year old but younger than 21 years old, or 21 years old or older. (i) “Risk assessment year” means the calendar year 2 years before the rate year. B. For calculating an adjustment to MCO payment rates reflecting the relative level of risk of providing enrollees assigned to demographic rate cells covered health care services pursuant to COMAR 10.67.06, the Department shall, for each MCO, identify the enrollees to be considered as follows: (1) For each rate adjustment period in the rate year, identify the current demographic enrollees for each MCO who: (a) In the risk assessment year: (i) Were certified eligible for the Program for at least 6 months; (ii) Were assigned to a demographic rate cell; and (iii) As of June 30, were 1 year old or older; and (b) In the calendar year before the rate year: (i) For the initial rate adjustment period calculation for the rate year 2004, were enrolled in the MCO in March; (ii) For the initial rate adjustment period calculation for rate years after 2004, were enrolled in the MCO in June; and (iii) For the mid-year rate adjustment period calculation, were enrolled in the MCO in December; (2) Assign each enrollee identified pursuant to §B(1) of this regulation into one of the eight risk assessment cohorts; (3) Make the determinations necessary for the assignments required by §B(2) of this regulation consistent with the following time frames: (a) For an initial rate adjustment period calculation for the rate year 2004: (i) An enrollee's eligibility category and region of residence as of March of the calendar year before the rate year; and (ii) An enrollee's age category as of March 31 of the calendar year before the rate year; (b) For an initial rate adjustment period calculation for rate years after 2004: (i) An enrollee's eligibility category and region of residence as of June of the calendar year before the rate year; and (ii) An enrollee's age category as of June 30 of the calendar year before the rate year; and (c) For a mid-year rate adjustment period calculation: (i) An enrollee's eligibility category and region of residence as of December of the calendar year before the rate year; and (ii) An enrollee's age category as of December 31 of the calendar year before the rate year; and (4) For calculating an MCO's case mix adjustment pursuant to this regulation, disregard any risk assessment cohorts to which fewer than 50 of an MCO's enrollees are assigned pursuant to §B(2) of this regulation. C. Methodology for Determining MCO-specific RAC Case Mix Measures. For each MCO, the Department shall: (1) Based on encounter and fee-for-service data documenting services delivered during the risk assessment year, determine the diagnoses attributable to an MCO's enrollees identified pursuant to §B of this regulation; (2) Based on diagnoses in the risk assessment year, assign each enrollee identified pursuant to §B of this regulation to the appropriate risk adjustment category (RAC), consistent with the protocol set forth in Regulation .19B(1)(a) and (2)(a) of this chapter; (3) Apply the RAC rates for the appropriate rate adjustment period to the RAC distribution determined pursuant to §C(2) of this regulation; (4) Using the results of the calculations specified in §C(3) of this regulation, calculate an MCO's average RAC rates separately for each of the MCO's risk assessment cohorts derived in accordance with §B of this regulation; and (5) To determine an MCO's relative RAC case mix factors, divide each of the MCO's average RAC rates determined in accordance with §C(4) of this regulation by each overall average RAC rate for all MCOs for the same risk assessment cohort. D. Methodology for Determining MCO-specific Demographic Case Mix Measures. For each MCO, the Department shall: (1) Determine the demographic distribution of its current enrollees as specified in §B of this regulation; (2) Apply the appropriate demographic rates for the rate adjustment period to the demographic distribution as determined pursuant to §D(1) of this regulation; (3) Using the results of the calculations specified in §D(2) of this regulation, calculate the MCO's average demographic rates separately for each of the MCO's risk assessment cohorts derived in accordance with §B of this regulation; and (4) To determine an MCO's relative demographic case mix factors, divide each of the MCO's average demographic rates determined pursuant to §D(3) of this regulation by each of the overall average of demographic rates for all MCOs for the same risk assessment cohort. E. MCO-Specific Case Mix Adjusted Demographic Rates. The Department shall, for each MCO: (1) Calculate MCO-specific risk adjustment factors by dividing, for each risk assessment cohort, the relative RAC case mix factor determined pursuant to §C of this regulation, by the relative demographic case mix factor determined pursuant to §D of this regulation; (2) Modify the MCO-specific risk adjustment factor derived for each risk assessment cohort pursuant to §E(1) of this regulation as follows: (a) Reduce each risk adjustment factor that is higher than 1.1 to 1.1; and (b) Increase each risk adjustment factor that is lower than 0.9 to 0.9; (3) Subject to §E(4) of this regulation, calculate the MCO-specific demographic rates for the rate adjustment period by multiplying the risk adjustment factor for each risk assessment cohort, derived pursuant to §E(1) of this regulation, by the value specified in each demographic rate cell for the rate year; and (4) Apply a budget neutrality adjustment to the values derived in §E(3) of this regulation so that aggregate payments to all MCOs pursuant to this regulation are equivalent to the aggregate payments that would be due to all MCOs in the absence of this regulation. F. Case Mix Updates. The Department shall: (1) Repeat the calculations described in §§C—E of this regulation every 6 months to update current MCO enrollees' region of residence, age, and enrollment categories as of the calendar year before the rate year, as provided in §B(3) of this regulation; and (2) For the rate adjustment periods beginning January 1 and July 1 of each rate year, use each MCO's updated RAC case mix measures and updated demographic case mix measures to compute its demographic rates for the rate adjustment period, as described in §E of this regulation. #### Regulation .19-4 MCO Medical Loss Ratio. *COMAR 10.67.04.19-4* A. By September 1 of the second calendar year following the MLR reporting year, each MCO shall provide to the Department a completed MLR Reporting Template, including the MCO attestation and any additional documentation supporting the MLR reporting template. B. The MLR experienced for each MCO in an MLR reporting year is the ratio of the numerator, as defined in §D of this regulation, to the denominator, as defined in §E of this regulation. C. An MLR may be increased by a credibility adjustment, in accordance with §G of this regulation. D. Components of MLR — Numerator. (1) The numerator of an MCO's MLR for an MLR reporting year is the sum of the MCO's incurred claims, the MCO's expenditures for activities that improve health care quality, and fraud prevention activities. (2) Incurred Claims. Incurred claims include the following: (a) Direct claims that the MCO paid to providers, including under capitated contracts with network providers, for services or supplies covered under the contract and services meeting the requirements of 42 CFR §438.3(e) provided to enrollees; (b) Unpaid claims liabilities for the MLR reporting year, including claims reported that are in the process of being adjusted or claims incurred but not reported; (c) Withholds from payments made to network providers; (d) Claims that are recoverable for anticipated coordination of benefits; (e) Claims payments recoveries received because of subrogation; (f) Incurred but not reported claims based on past experience, and modified to reflect current conditions, such as changes in exposure or claim frequency or severity; (g) Changes in other claims-related reserves; and (h) Reserves for contingent benefits and the medical claim portion of lawsuits. (3) An MCO shall deduct the following amounts from incurred claims: (a) Overpayment recoveries received from network providers; and (b) Prescription drug rebates received and accrued. (4) An MCO shall include the following expenditures in incurred claims: (a) The amount of incentive and bonus payments made, or expected to be made, to network providers; and (b) The amount of claims payments recovered through fraud reduction efforts, not to exceed the amount of fraud reduction expenses, and excluding activities specified in §D(3) of this regulation; (5) An MCO may include or deduct the following amounts from incurred claims: (a) Net payments; or (b) Receipts related to State-mandated solvency funds; (6) An MCO shall exclude the following amounts from incurred claims: (a) Non-claims costs; (b) Amounts paid to the State as remittance under §I of this regulation; and (c) Amounts paid to network providers under to 42 CFR §438.6(d). (7) Non-claims costs as described in §D(6)(a) of this regulation include the following: (a) Amounts paid to third-party vendors for secondary network savings; (b) Amounts paid to third-party vendors for network development, administrative fees, claims processing, and utilization management; (c) Amounts paid, including amounts paid to a provider, for professional or administrative services that do not represent compensation or reimbursement for State plan services or services meeting the definition in 42 CFR §438.3(e) and provided to an enrollee; and (d) Fines and penalties assessed by regulatory authorities. (8) Incurred claims paid by one MCO that are later assumed by another MCO shall be reported by the assuming MCO for the entire MLR reporting year, and no incurred claims for that MLR reporting year may be reported by the ceding MCO. (9) An MCO shall include activities that improve health care quality in one of the following categories: (a) An MCO activity that meets the requirements of 45 CFR §158.150(b) and is not excluded under 45 CFR §158.150(c); (b) An MCO activity related to any EQR-related activity as described in 42 CFR §438.358(b) and (c); and (c) Any MCO expenditure that is related to Health Information Technology and meaningful use, meets the requirements placed on issuers found in 45 CFR §158.151, and is not considered incurred claims. (10) Excluding expenses for fraud reduction efforts in §D(4)(b) of this regulation, an MCO shall include expenditures on activities related to fraud prevention as adopted for the private market at 45 CFR part 158. E. Components of MLR Denominator. (1) The denominator of an MCO's MLR for an MLR reporting year shall equal the adjusted premium revenue. The adjusted premium revenue is the MCO's premium revenue minus the MCO's federal, State, and local taxes and licensing and regulatory fees and is aggregated in accordance with §F of this regulation. (2) Premium revenue includes the following for the MLR reporting year: (a) State capitation payments, developed in accordance with 42 CFR §438.4, to the MCO for all enrollees under a risk contract approved under 42 CFR §438.3(a), excluding payments made under 42 CFR §438.6(d); (b) State-developed, one-time payments, for specific life events of enrollees; (c) Other payments to the MCO approved under 42 CFR §438.6(b)(3); (d) Unpaid cost-sharing amounts that the MCO could have collected from enrollees under the contract, except those amounts the MCO can show it made a reasonable, but unsuccessful, effort to collect; (e) All changes to unearned premium reserves; and (f) Net payments or receipts related to risk sharing mechanisms developed in accordance with 42 CFR §438.5 or 42 CFR §438.6. (3) Federal, State, and Local Taxes and Licensing and Regulatory Fees. Taxes and licensing and regulatory fees for the MLR reporting year include: (a) Statutory assessments to defray the operating expenses of any State or federal department; (b) Examination fees in lieu of premium taxes as specified by State law; (c) Federal taxes and assessments allocated to MCOs excluding federal income taxes on investment income and capital gains and federal employment taxes; (d) State and local taxes and assessments including: (i) Any industrywide (or subset) assessments, other than surcharges on specific claims, paid to the State or locality directly; (ii) Guaranty fund assessments; (iii) Assessments of State or locality industrial boards or other boards for operating expenses or for benefits to sick employed persons in connection with disability benefit laws or similar taxes levied by states; (iv) State or locality income, excise, and business taxes other than premium taxes and State employment and similar taxes and assessments; and (v) State or locality premium taxes plus State or locality taxes based on reserves, if in lieu of premium taxes; and (e) Payments made by an MCO that are otherwise exempt from federal income taxes, for community benefit expenditures as defined in 45 CFR §158.162(c), limited to the highest of either: (i) 3 percent of earned premium; or (ii) The highest premium tax rate in the State for which the report is being submitted, multiplied by an MCO's earned premium in the State. (4) The total amount of the denominator for an MCO, which is later assumed by another MCO, shall be reported by the assuming MCO for the entire MLR reporting year and no amount under this section for that year may be reported by the ceding MCO. F. Allocation of Expense. (1) Each expense shall be included under only one type of expense, unless a portion of the expense fits under the definition of, or criteria for, one type of expense and the remainder fits into a different type of expense, in which case the MCO shall prorate the expense between types of expenses. (2) An MCO shall report on a pro-rata basis any expenditures that benefit multiple contracts or populations, or contracts other than those being reported. (3) Methods Used to Allocate Expenses. (a) An MCO shall base allocation to each category on a generally accepted accounting method that is expected to yield the most accurate results. (b) An MCO shall apportion shared expenses, including expenses under the terms of a management contract, pro rata to the contract incurring the expense. (c) The reporting entity shall bear any expenses that relate solely to its operation and may not apportion its operating expenses to other entities. G. Credibility Adjustment. (1) An MCO may add a credibility adjustment to a calculated MLR if the MLR reporting year experience has partial credibility. (2) An MCO shall add the credibility adjustment to the reported MLR calculation before calculating any remittances if required by the State as described in §I of this regulation. (3) An MCO may not add a credibility adjustment to a calculated MLR if the MLR reporting year experience has full credibility. (4) If an MCO's experience has no credibility, it is presumed to meet or exceed the MLR calculation standards in this regulation. (5) MCOs shall use the base credibility factors CMS publishes on an annual basis that are developed according to the methodology in 42 CFR §438.8(h)(4). H. Eligibility Groups. (1) MCOs shall aggregate data for all Medicaid eligibility groups covered under the contract with the Department. (2) MCOs shall report, and the Department shall calculate, an annual MLR as described in this regulation separately for the childless adult population. (3) The Department may require separate reporting and a separate MLR calculation for additional populations. I. An MCO shall provide a remittance for an MLR reporting year if the MLR for that MLR reporting year does not meet the minimum MLR standard of 85 percent. J. Newly Contracted MCOs. (1) The Department may exclude an MCO that is newly contracted with the State from the requirements in this section for the first year of the MCO's operation. (2) Newly contracted MCOs shall comply with the requirements in this section during the next MLR reporting year in which the MCO is in business with the State, even if the first year was not a full 12 months. K. If the Department makes a retroactive change to the capitation payments for an MLR reporting year where the report has already been submitted to the Department, the MCO shall recalculate the MLR for all MLR reporting years affected by the change and submit a new report. L. MCOs shall attest to the accuracy of the calculation of the MLR in accordance with requirements of this section when submitting its report to the Department. M. MCOs shall report fraud prevention activities as required by 42 CFR §438.8. N. Notice and Appeal. (1) Within 30 days of its receipt of the notice of a remittance being due to the Department, an MCO may appeal the remittance as a sanction pursuant to COMAR 10.67.10.02. (2) An MCO's appeal does not stay the obligation of the MCO to remit the amount owed to the Department. #### Regulation .20 MCO Payment for Self-Referred, Emergency, Physician, and Hospital Services. *COMAR 10.67.04.20* A. MCO Payment for Self-Referred Services. (1) For undisputed claims that are submitted to the MCO within 6 months of the date of service, an MCO shall reimburse out-of-plan providers within 30 days for eligible services performed upon an enrollee who has self-referred: (a) To a school-based health clinic pursuant to COMAR 10.67.06.28B, for services described in COMAR 10.67.07; (b) For family planning services, pursuant to COMAR 10.67.06.28A; (c) For an initial medical examination for an enrollee who is a child in State-supervised care, pursuant to Regulation .13F of this chapter; (d) For one annual diagnostic and evaluation service visit for an enrollee diagnosed with human immunodeficiency virus or acquired immune deficiency syndrome (HIV/AIDS) pursuant to COMAR 10.67.06.28E; (e) For obstetric and gynecologic care provided to a pregnant woman, under the circumstances described in COMAR 10.67.06.28C; and (f) For an initial medical examination of a newborn when the: (i) Examination is performed in a hospital by an on-call physician; and (ii) MCO failed to provide for the service before the newborn's discharge from the hospital. (2) An MCO shall reimburse out-of-plan providers to whom enrollees have self-referred for school-based services as described in COMAR 10.67.07.03 and family planning services including office visits (CPT codes 9920199205 and 9921199215), preventive medicine office visits (CPT codes 9938399386 and 9939399396), and all FDA-approved contraceptive devices, methods and supplies, at the established Medicaid rates. (3) An MCO shall reimburse out-of-plan providers to whom enrollees have self-referred for an initial examination for a child in State-supervised care utilizing the Medicaid payment schedule for the following procedure codes: (4) An MCO shall reimburse out-of-plan providers rendering pregnancy-related services, as described in COMAR 10.67.06.28, at the Medicaid rate. (5) An MCO shall reimburse out-of-plan providers performing the DES for HIV/AIDS at the Medicaid rate. (6) An MCO may require enrollees to utilize in-plan providers for pharmacy and laboratory services ordered by out-of-plan providers of self-referral services, except as provided in §A(7) of this regulation. (7) An MCO shall reimburse out-of-plan providers at the Medicaid rate for medically necessary pharmacy and laboratory services when the pharmacy or laboratory service is provided: (a) In connection with a self-referred service specified in §A(1) of this regulation; and (b) On-site by the out-of-plan provider at the same location that the self-referred service specified in §A(1) of this regulation was delivered to the MCO's enrollee. (8) An MCO shall reimburse out-of-plan providers for renal dialysis services in a Medicare-certified facility, at least the Medicaid rate, regardless of whether or not the MCO's preauthorization was secured. (9) An MCO shall reimburse out-of-plan providers under the circumstances described in COMAR 10.67.06.28G at a rate not less than the fee-for-service Medicaid rate for an initial medical examination of a newborn when the mother's MCO fails to provide for the service before the newborn is discharged from the hospital. (10) An MCO shall reimburse out-of-plan providers at the Medicaid fee-for-service rate for services performed in a free-standing birth center as described in COMAR 10.67.06.28. (11) An MCO shall reimburse out-of-plan doulas at the Medicaid fee-for-service rate for services performed during the prenatal, labor and delivery, and postpartum periods of pregnancy as described in COMAR 10.67.06.28 through December 31, 2025. B. MCO Payment for Emergency Services Provided at a Hospital. An MCO shall reimburse a hospital emergency facility and provider, which is not required to obtain prior authorization or approval for payment from an MCO in order to obtain reimbursement under this regulation, for: (1) Health care services that meet the definition of emergency services in Health-General Article, §19-701, Annotated Code of Maryland; (2) Medical screening services rendered to meet the requirements of the federal Emergency Medical Treatment and Active Labor Act; (3) Medically necessary services if the MCO authorized, referred, or otherwise instructed the enrollee to use the emergency facility and the medically necessary services are related to the emergency condition; and (4) Medically necessary services that relate to the condition presented and that are provided by the provider in the emergency facility to the enrollee if the MCO fails to provide 24-hour access to a physician. C. MCO Payment to an Out-of-Network Federally Qualified Health Center for Services Immediately Required Due to an Unforeseen Illness, Injury, or Condition. (1) Effective October 1, 2010, an MCO shall reimburse an out-of-network federally qualified health center (FQHC) for services provided to an enrollee that are immediately required due to an unforeseen illness, injury, or condition if: (a) The FQHC participates in the Medical Assistance Program; (b) The FQHC does not have a contract with the MCO; (c) The services are immediately required due to the enrollee's unforeseen illness, injury, or condition; (d) The emergent services are provided on site at the FQHC; and (e) The FQHC has, before rendering services, verified with the enrollee's primary care provider that the enrollee cannot be seen within a reasonable amount of time based on the severity of the enrollee's condition. (2) An MCO may require that the FQHC provide documentation that the FQHC has obtained the verification required under §C(1)(e) of this regulation. An MCO is not required to reimburse an out-of-network FQHC for emergent services provided to an enrollee if the FQHC fails to provide the documentation. (3) An MCO may require that the FQHC provide documentation that services were required for the reasons identified under §C(1)(c) of this regulation. An MCO is not required to reimburse an out-of-network FQHC for emergent services provided to an enrollee if the FQHC fails to provide the documentation. (4) The rate at which the MCO shall reimburse an out-of-network FQHC for services provided under §C(1) of this regulation shall be the rate identified in COMAR 10.67.04.21. (5) For any reimbursement paid by an MCO under §C of this regulation, the Program shall pay the MCO the difference between the rates identified in COMAR 10.67.04.21 and COMAR 10.09.08.05-1. D. MCO Payment for Provider Services. (1) An MCO shall pass on to providers any MCO rate adjustment that is specified by the Department for a fee increase. (2) For inpatient services performed in hospitals, an MCO shall pay all providers, regardless of the provider's contracting status, at least the Medicaid fee-for-service rate. (3) The MCO may not be required to pay providers more than the Medicaid fee-for-service rate. E. Payment for Hospital Services. (1) An MCO shall reimburse Maryland hospital providers on the basis of rates approved by the Maryland Health Services Cost Review Commission (HSCRC). (2) An MCO shall reimburse hospital administrative days at the Medicaid fee-for-service rate. (3) Upon the direction of the Department, an MCO shall reduce payments by 20 percent to a hospital located in a contiguous state or in the District of Columbia for services rendered to its enrollees, if the hospital has failed to supply appropriate discharge data to the Health Services Cost Review Commission. #### Regulation .21 Payments to Federally Qualified Health Centers (FQHC). *COMAR 10.67.04.21* A. FQHC’s shall be reimbursed under the Alternative Payment System (APS). (1) The Department shall: (a) Pay the MCO a prospective payment based on encounter data; and (b) Reconcile the prospective amount paid to the MCO with the MCO's actual expenditure amount, after receipt of MCO encounter data; and (2) MCOs shall reimburse any contracted FQHC, the FQHC’s rate established in accordance with COMAR 10.09.08.05-1A. B. For self-referred services described in Regulation .20 of this chapter, the MCO shall pay the FQHC’s usual rate in accordance with §A of this regulation, regardless of the FQHC’s contracted status with the MCO. #### Regulation .22 Stop Loss Program. *COMAR 10.67.04.22* A. An MCO shall qualify for protection under the Stop Loss Program if: (1) It was participating in HealthChoice as of April 1, 1999; (2) It was unable to self-insure or obtain a contract with another entity for Stop Loss reinsurance after July 1, 1999; and (3) By July 1, 1999, the MCO requested the Department to continue to provide Stop Loss Protection at a rate determined by the Department. B. An MCO shall notify the Department that the acute inpatient hospital costs of an enrollee are expected to exceed the Stop Loss limit as soon as it knows that this is likely to occur. C. Upon confirming eligibility for stop loss protection, the Department shall assume liability for reimbursement of 90 percent of accrued acute inpatient hospital charges according to established Medicaid fee-for-service rates for medically necessary acute inpatient treatment rendered to the enrollee above the stop loss limit throughout the remainder of the calendar year. D. An MCO shall remain financially liable for reimbursing 10 percent of accrued acute inpatient hospital charges for medically necessary treatment rendered to the enrollee above the stop loss limit throughout the remainder of the calendar year, and shall maintain full responsibility for the provision of health care services to the enrollee. E. At the beginning of the next calendar year, an MCO shall reassume full financial responsibility and full discretion for developing medical treatment plans for any enrollee who qualified for the Stop Loss Program. F. The Department's Extended Stop Loss Period. (1) If an inpatient enrollee remains hospitalized at the end of a calendar year and incurs acute hospital costs that exceed the Stop Loss limit into the following calendar year without interruption, the Department's stop loss period shall be extended until the end of that hospitalization. (2) The MCO shall remain financially liable for costs up to the Stop Loss limit for enrollees who remain hospitalized in an acute setting at the end of the calendar year as specified in §§A and D of this regulation until the enrollee is discharged. G. For calendar year 2001 and beyond, the MCO shall submit the MCO's Stop Loss Reinsurance Plan or Self-Insurance Plan to the Maryland Insurance Administration. H. If an MCO chooses to have the Department provide its Stop Loss coverage, an adjustment will be made to the capitation amount the MCO is paid. I. Upon the termination of the provider agreement between the enrollee's MCO and the Department, if an MCO has failed to fulfill its financial liability under this regulation, the Department shall assume responsibility only for costs that exceed the Stop Loss limit as specified in §C of this regulation. #### Regulation .23 Marketing. *COMAR 10.67.04.23* A. An MCO may not have face-to-face or telephone contact with a recipient, or otherwise solicit a recipient who is not an enrollee of the MCO, unless authorized by the Department or the recipient initiates the contact. B. Subject to prior approval by the Department, an MCO may engage in marketing activities designed to make recipients aware of their availability, as well as any special services they offer. Unless they involve face-to-face solicitation, these marketing activities may involve campaigns using but not limited to: (1) Television; (2) Radio; (3) Newspaper; (4) Informational booths at public events; (5) Billboards and other public displays; (6) Addressee-blind informational mailings, but only when mailed to the MCO's entire service area; (7) Magazines; (8) Airborne marketing displays; or (9) Public conveyances. C. An MCO may not engage in any cold call marketing, including activities using or involving any of the following mechanisms: (1) Direct marketing; (2) Telephone solicitation; (3) Door to door flyers; (4) Email; (5) Texting; (6) Material or financial incentives of any kind, with the exception of advertising trinkets such as balloons or pens that have an acquisition cost of $5 or less; or (7) Influencing enrollment in conjunction with the sale or offer of private insurance. D. Standards for Departmental Approval of MCO Advertising. (1) MCO advertising shall: (a) Be based on documented fact; (b) Identify all telephone numbers used that do not belong to the MCOs; (c) Include the statement, “'HealthChoice' is a program of the Maryland Department of Health”; and (d) Be at a fifth grade reading level. (2) MCO advertising may not: (a) Be false or misleading; (b) Ascribe to the MCO unique coverage or services that are otherwise required by State or federal law or regulation; (c) Assert that a recipient shall enroll in the MCO in order to obtain benefits or in order not to lose benefits; or (d) Assert that the MCO is endorsed by CMS, the federal or State government or similar entity. #### Regulation .24 Repealed. *COMAR 10.67.04.24* #### Regulation .25 Enrollee Outreach Plan. *COMAR 10.67.04.25* A. An MCO shall submit to the Department, on an annual basis, a written enrollee outreach plan that: (1) Describes how the MCO intends to comply, in the upcoming year, with the outreach requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland; and (2) Provides evidence of the MCO's compliance during the previous year, with the outreach requirements of Health-General Article, §15-103(b)(9), Annotated Code of Maryland. B. Submission Date. (1) An MCO applicant shall submit its initial enrollee outreach plan, as part of its MCO application, as required by COMAR 10.09.64.06O. (2) An MCO shall submit by December 1 an enrollee outreach plan, including the information specified in §A of this regulation, to be reviewed as part of the triennial audit performed by an external quality review organization (EQRO). (3) For years in which the triennial EQRO audit is not performed, an MCO shall submit by April 30 any changes to the enrollee outreach plan, including the information specified in §A of this regulation. #### Regulation .26 Time Period for Termination of Provider Agreement. *COMAR 10.67.04.26* A. An MCO may terminate its provider agreement with the State as provided in §§B—D of this regulation. B. The MCO shall provide written notification to the Department of the MCO's intent to terminate the MCO's provider agreement with the State for any given calendar year by the previous October 1. C. An MCO that has previously terminated the provider agreement with the State and would like to sign a new agreement with the State, shall follow the application process as specified under COMAR 10.67.03. D. The Department may waive the requirement under §B of this regulation if the Department determines that the circumstances warrant, including but not limited to a reduction in rates outside the normal rate setting process or an MCO exit from the program. #### Regulation .27 Newborn Coordinator. *COMAR 10.67.04.27* A. An MCO shall identify a newborn coordinator who shall be available to providers during the MCO's business hours as a contact for concerns related to eligibility and provision of services to newborns. B. The newborn coordinator shall provide services for a newborn: (1) Whose mother is enrolled in the MCO on the date of the newborn's birth; and (2) Who is enrolled or who is autoassigned to the MCO after birth. C. The newborn coordinator shall: (1) Research and confirm the assignment of an eligible newborn to a managed care organization; (2) Interface with the enrollment agent, the Department, the newborn coordinators of other MCOs, and the provider to resolve any eligibility issues involving multiple MCOs; (3) Facilitate and confirm the selection of a primary care provider for an eligible newborn; (4) Request an MCO ID card for a newborn when necessary; (5) Make retroactive PCP enrollments when necessary; (6) Facilitate the resolution of claims for services provided to an eligible newborn; (7) Provide general guidance to providers and their office staff on newborn-related issues; (8) Coordinate with ancillary care providers to facilitate appropriate delivery of care and payment of claims; and (9) Coordinate and authorize in-network care when the newborn does not yet appear in EVS or the MCO's system, or out-of-network care when the MCO cannot offer an appropriate in-network provider. ### Chapter 05 — Maryland Medicaid Managed Care Program: Access **Authority:** Health-General Article, §§2-104, 15-102.1(b)(10), 15-102.3 and 15-103; Insurance Article §§15-112, 15-605, and 15-1008; Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.08 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .01A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); November 7, 2016 (43:22 Md. R. 1221) **Administrative History:** Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .02 amended effective February 18, 2002 (29:3 Md. R. 220); June 30, 2008 (35:13 Md. R. 1180); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .02B, C amended effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulations .03 and .04 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 **Administrative History:** Regulation .03 amended effective February 9, 1998 (25:3 Md. R. 144); February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .03D amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .04 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .04A amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .04A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .04A amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .04A, B amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .04A, C amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .04C amended effective December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .05 amended effective April 10, 2006 (33:7 Md. R. 668); June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .05A amended effective June 25, 2001 (28:12 Md. R. 1109) **Administrative History:** Regulation .05A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .05A amended effective February 16, 2015 (42:3 Md. R. 316); February 1, 2016 (42:23 Md. R. 1434) **Administrative History:** Regulation .05B amended effective April 19, 2010 (37:8 Md. R. 615); February 6, 2012 (39:2 Md. R. 141) August 29, 2016 (43:17 Md. R. 955); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .05-1 adopted effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .05-1 amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .06 amended effective April 28, 2014 (41:8 Md. R. 471); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .06A amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .06B amended effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .06E amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .06E amended effective April 9, 2007 (34:7 Md. R. 698); November 5, 2007 (34:22 Md. R. 1977) **Administrative History:** Regulation .07A amended effective February 2, 2004 (31:2 Md. R. 82); April 19, 2010 (37:8 Md. R. 615); February 6, 2012 (39:2 Md. R. 141); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .07A, D amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .07B, C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .07B, D amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .07B, C amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .08 amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .08B, F amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .09 adopted effective March 14, 2016 (43:5 Md. R. 385) **Administrative History:** Regulation .09 amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred from COMAR 10.09.66 effective November 1, 2019 (46:22 Md. R. 977) **Administrative History:** Regulation .01B amended effective June 13, 2022 (49:12 Md. R. 641) **Administrative History:** Regulation .02C amended effective June 24, 2024 (51:12 Md. R. 620) **Administrative History:** Regulation .02G amended effective June 13, 2022 (49:12 Md. R. 641) **Administrative History:** Regulation .04A amended effective June 13, 2022 (49:12 Md. R. 641) **Administrative History:** Regulation .05-1A amended effective April 28, 2025 (52:8 Md. R. 359) **Administrative History:** Regulation .05-1C amended effective October 18, 2021 (48:21 Md. R. 889); April 28, 2025 (52:8 Md. R. 359) #### Regulation .01 Access Standards: Addressing Enrollees' Individualized Needs. *COMAR 10.67.05.01* A. An MCO shall provide access to health care services and information in a manner that addresses the individualized needs of its enrollees, regardless of gender, sexual orientation, or gender identity, including, but not limited to, the delivery of services and information to enrollees: (1) In a culturally sensitive manner; (2) At an appropriate reading comprehension level; (3) In the prevalent non-English languages identified by the State; and (4) In a manner that accommodates individuals with disabilities consistent with the requirements of the Americans with Disabilities Act of 1990, P.L. 101-330, 42 U.S.C. §12101 et seq., and regulations promulgated under it. B. Special Access. (1) An MCO shall notify enrollees of the following services and make them available free of charge to the enrollee: (a) Written materials in the prevalent non-English languages identified by the State; (b) Written materials in alternative formats; (c) Oral interpretation services in all non-English languages; and (d) Auxiliary aids and services, such as: (i) Teletypewriter/Telecommunication Device for the Deaf (TTY/TDD); and (ii) American Sign Language. (2) An MCO shall include taglines in the prevalent non-English languages identified by the State with its written materials critical to obtaining services that: (a) Explain the availability of written translation or oral interpretation to understand the information provided; and (b) Provide the toll-free and TTY/TDD telephone number of the MCO’s customer service unit. C. Written Materials. An MCO shall provide all its written materials in the following manner: (1) Using language and a format that is easily understood; (2) In a font size no smaller than 12 point; (3) Available in alternative formats and through the provision of auxiliary aids and services; and (4) Available in an appropriate manner that takes into consideration the special needs of enrollees or potential enrollees with disabilities or limited English proficiency. D. An MCO may provide enrollee information electronically so long as all of the following requirements are met: (1) The format is readily accessible; (2) The information is placed in a location on the MCO’s website that is prominent and readily accessible; (3) The information is provided in an electronic form which can be electronically retained and printed; (4) The information is consistent with the content and language requirements of this section; (5) The enrollee is informed that the information is available in paper form without charge upon request; and (6) Should the enrollee request it, the MCO provides the information in paper form within 5 business days. #### Regulation .02 Access Standards: Enrollee Handbook and Provider Directory. *COMAR 10.67.05.02* A. An MCO shall inform and educate its enrollees about: (1) Basic information about the MCO; (2) The availability of health care services and how to access them; (3) The definitions of managed care terminology in accordance with 42 CFR 438.10(c)(4)(i); and (4) Enrollee's rights and responsibilities in the MCO, and that the exercise of those rights does not adversely affect the way the MCO, its providers, or the Department treats the enrollee. B. An MCO shall, at the time of enrollment, and anytime upon request, furnish each enrollee with a copy of the MCOs enrollee handbook that includes all language in the template provided by the Department and the following current information: (1) The enrollee's rights and responsibilities in the MCO as described in 42 CFR §438.100(b)(1), as amended; (2) Information on how to access urgent care and emergency care services, including: (a) What constitutes an emergency medical condition and emergency services; (b) The following facts: (i) Prior authorization is not required for these services; and (ii) The enrollee has a right to use any hospital or other setting for emergency care; (3) The services included in the MCO's benefits package, including optional benefits provided by the MCO; (4) How and where to access any benefits provided by the State, including any cost sharing, and how transportation is provided; (5) The amount, duration, and scope of benefits available in sufficient detail to ensure that enrollees understand the benefits to which they are entitled; (6) The availability of behavioral health services that are not included in the MCOs benefits package, and how to access these services; (7) Information on the availability of self-referral services as well as any restrictions on the enrollee's freedom of choice among network providers; (8) Information about how enrollees may obtain benefits from out-of-network providers; (9) Any policies and procedures necessary to facilitate accessing needed services in compliance with the Maryland Medicaid Managed Care Program, including any requirements for service authorizations or referrals for specialty care and for other benefits not furnished by the enrollee's primary care provider; (10) Information about the availability of EPSDT, prenatal care, family planning, and other wellness services, including education programs; (11) A statement that the MCO cannot require an enrollee to obtain a referral before choosing a family planning provider; (12) The process of selecting and changing the enrollee's primary care provider; (13) A description of any benefits the MCO offers in addition to those required by the Maryland Medicaid Managed Care Program, including applicable terms and conditions for accessing those benefits; (14) Information on how to access auxiliary aids and services, including additional information in alternative formats or languages; (15) The toll-free telephone number for member services, medical management, and any other unit providing services directly to enrollees, including: (a) A description of each unit and number; (b) An explanation of how the phone numbers can be used to obtain information and assistance; and (c) An explanation of the MCOs internal grievance procedure. (16) Information regarding the importance of scheduling and maintaining appointments for preventive services; (17) If applicable, a list of services that are not covered by the MCO because of moral or religious objections, and a statement that informs the enrollee that the State will provide information on how and where to obtain these services; (18) The rule pertaining to poststabilization care services, as set forth in Regulation .08G of this chapter; (19) Appeal, grievance, and fair hearing procedures and time frames that include the following: (a) The right to a State fair hearing, including the method for obtaining a hearing and the rules that govern representation at the hearing; (b) The right to file appeals and grievances; (c) The requirements and time frames for filing an appeal or grievance; (d) The availability of assistance in the filing process; (e) The toll-free numbers that the enrollee may use to file an appeal or grievance by phone; (f) The fact that, if requested by the enrollee, the benefits will continue if the enrollee files an appeal or a request for a State fair hearing within the time frames specified for filing; and (g) That the enrollee may be required to pay the cost of the services furnished while the appeal is pending, if the final decision is adverse to the enrollee; (20) Any appeal rights the State chooses to make available to providers; (21) Advanced directives as set forth in 42 CFR §438.3(j)(1), as amended; (22) Information on how to report suspected fraud or abuse; (23) Additional information that is available upon request, including the following: (a) Information on the structure and operation of the MCO; and (b) Physician incentive plans. (24) Information on how to access or obtain the MCOs provider directory. C. Provider Directory. (1) An MCO shall provide enrollees with information regarding their provider networks including: (a) Its primary care service locations; (b) A listing of the MCOs hospital providers, of both inpatient and outpatient services, in the enrollee's county, their addresses, and services provided; (c) A listing of the MCOs pharmacy providers in the enrollee's county and their addresses; and (d) A listing of the individual practitioners who are the MCOs primary and specialty care providers in the enrollee's county, grouped by medical specialty, giving: (i) Name; (ii) Address; (iii) Practice location or locations; (iv) Telephone number or numbers; (v) Website URL, as appropriate; (vi) Any group affiliation, as appropriate; (vii) Cultural and linguistic capabilities, including languages offered by the provider or a skilled medical interpreter at the provider’s offices, American Sign Language interpretation; (viii) An indication of whether the provider's office or facility has accommodations for physical disabilities, including offices, exam room or rooms and equipment; (ix) An indication of whether or not the provider is accepting new patients; (x) An indication of the age range of patients accepted or whether there is no age limit; and (xi) If applicable, how access to the provider is otherwise limited. (2) Upon request by an enrollee, an MCO shall furnish a paper copy of the provider directory. D. An MCO shall notify all enrollees of their right to request and obtain the information listed in §§B and C of this regulation at least once a year. E. The Department may consider the information listed in §§B and C of this regulation to be provided if the MCO: (1) Mails a printed copy of the information to the enrollee's mailing address; (2) Provides the information by email after obtaining the enrollee's agreement to receive the information by email; (3) Posts the information on the MCOs website and advises the enrollee in paper or electronic form that the information is available on the internet and includes the applicable internet address, provided that enrollees with disabilities who cannot access this information online are provided auxiliary aids and services upon request at no cost; or (4) Provides the information by any other method that can reasonably be expected to result in the enrollee receiving that information. F. An MCO shall update its online provider directory no later than 30 days after the MCO receives updated provider information. G. An MCO shall update its paper directory: (1) Monthly if the MCO does not have a mobile-enabled electronic directory; or (2) Quarterly if the MCO has a mobile-enabled electronic directory. H. An MCO shall make provider directories available on its website in a machine-readable file and format as specified by the Secretary for the U.S. Department of Health and Human Services. #### Regulation .03 Access Standards: Outreach. *COMAR 10.67.05.03* A. An MCO is responsible for delivering needed health care services even when the enrollee is difficult to reach or misses appointments. B. The assistance of local health departments in contacting and bringing into care enrollees who are difficult to reach or miss appointments is available for the specific categories of enrollees identified in this regulation, but only after the MCO has made documented attempts to contact and bring into care an enrollee who is difficult to reach or misses appointments before seeking the assistance of the local health department. C. Adults. (1) An MCO shall, before referring the enrollee to the local health department, make documented attempts to ensure that follow-up appointments are scheduled in accordance with the enrollee's treatment plan by attempting a variety of contact methods, which may include: (a) Written correspondence; (b) Telephone contact; and (c) Face-to-face contact. (2) If the enrollee, due to impaired cognitive ability or psychosocial problems such as homelessness or other conditions, can be expected to have difficulty understanding the importance of treatment instructions or difficulty navigating the health care system, the MCO shall, after exhausting its best efforts to contact and bring into care the enrollee in accordance with §C(1) of this regulation, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance within 10 business days of whichever first occurs: (a) The third consecutive missed appointment; or (b) The MCO or the enrollee's provider identifies the enrollee's repeated noncompliance with a regimen of care. D. Child Younger than 2 Years Old Needing EPSDT Screening Services. (1) An MCO shall ensure that appointments are scheduled in accordance with the EPSDT periodicity schedule or within 30 days of the MCO's receipt of the health risk assessment, whichever is less. (2) If the enrollee fails to keep the appointment, the MCO shall ensure that a second appointment is scheduled within 30 days. (3) If the enrollee misses the second appointment, a third appointment shall be scheduled within 30 days. (4) For each scheduled appointment, the MCO shall: (a) Provide written notice to the enrollee's parent, guardian, or caretaker of the appointment dates; and (b) Attempt to notify the enrollee's parent, guardian, or caretaker of the appointment dates by telephone. (5) If the enrollee misses the second appointment in a row, after the MCO has made the notification attempts required by §C(1) of this regulation, the MCO shall, within 10 business days, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care. (6) After referral to the local health department, the MCO shall continue to work collaboratively with the local health department to bring the enrollee into care until the enrollee comes back into compliance with the EPSDT periodicity schedule. E. Child Younger than 21 Years Old Needing Follow-up Treatment. (1) An MCO shall ensure that an appointment for follow-up care is scheduled at a time interval appropriate to the enrollee's diagnosed condition. (2) If the enrollee fails to keep the appointment, the MCO shall reschedule the appointment for the enrollee to be seen within 30 days. (3) For each scheduled appointment, the MCO shall: (a) Provide written notice to the enrollee, or to the enrollee's parent, guardian, or caretaker, as appropriate, of the appointment dates by mail; and (b) Attempt to notify the enrollee, or the enrollee's parent, guardian, or caretaker, as appropriate, of the appointment dates by telephone. (4) If the enrollee misses the second consecutive follow-up appointment after the MCO has made the notification attempts required by §C(1) of this regulation, the MCO shall, within 10 business days, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care. (5) After referral to the local health department, the MCO shall work collaboratively with the local health department to bring the enrollee into care. F. Pregnant or Postpartum Woman Needing Prenatal or Postpartum Care. (1) Initial Visit. An MCO shall schedule an initial visit for the pregnant or postpartum enrollee to be seen within 10 days of her request for an appointment. If she fails to appear for the appointment, the MCO shall reschedule in a timely manner appropriate to her medical condition. (2) Follow-Up Appointments. After the enrollee has completed an initial visit that includes a comprehensive history, physical exam, and completion of the Maryland Prenatal Risk Assessment, the MCO shall ensure that appointments are scheduled for the enrollee in compliance with the periodicity schedule of the ACOG guidelines. If the enrollee fails to appear for a scheduled appointment, the MCO shall ensure that the appointment is rescheduled for the enrollee to be seen within 10 days. (3) For each scheduled appointment, the MCO shall: (a) Provide written notice to the enrollee of the appointment dates; and (b) Attempt to notify the enrollee of the appointment dates by telephone. (4) After making the attempts specified in §F(3) of this regulation, if the MCO is unable to bring the enrollee into care within 30 days of the first missed appointment, the MCO shall, within 10 days of the last missed appointment, make, or ensure that the enrollee's provider makes, a written referral to the local health department for its assistance in bringing the enrollee into care. (5) After referral to the local health department, the MCO shall work collaboratively with the local health department to bring the patient into care, until the enrollee comes back in compliance with the ACOG periodicity schedule. #### Regulation .04 Access Standards: Information for Providers. *COMAR 10.67.05.04* A. An MCO shall develop and make available either electronically or by hard copy to all of its PCP and specialty care providers a Medicaid requirements manual, including periodic updates as appropriate, and shall: (1) Before distribution, file a copy of its manual with the Department for review; (2) Include in its manual the information necessary to facilitate the providers’ full compliance with federal and State Medicaid requirements, including information on: (a) Medicaid statutes and regulations; (b) The benefits package, including optional benefits; (c) Access requirements, which, at a minimum, comply with the requirements of this chapter; (d) Quality requirements, which shall, at a minimum, comply with the requirements of COMAR 10.67.04.03; (e) Continuity of care requirements; (f) Requirements for referral to specialist, ancillary, and other providers as necessary to provide the full range of medically necessary services that are covered by the Maryland Medicaid Managed Care Program; and (g) The MCO’s practice guidelines as described in 42 CFR §438.236. (3) Inform the MCO’s primary and specialty care providers of their responsibility to provide or arrange for medically necessary accessible health care services that are continuous, comprehensive, and coordinated for each enrollee, including: (a) Preventive health services; (b) Primary acute medical care; (c) Chronic medical care; (d) Consultation, referral, and follow-up in areas including medical specialties and child dental care; (e) Referral for ancillary and support-related services including but not limited to: (i) Drug therapies; (ii) Diagnostic tests; (iii) Medical supplies; (iv) Durable medical equipment; and (v) Case management when appropriate for complex conditions; (f) 24-hour per day, 7-day per week provider coverage for medically necessary services; (g) Maintenance of a medical record, including records of referral arrangements and outcomes of those referrals; and (h) Detection of mental health problems or substance use disorder during routine or follow-up screening, to be treated either through the MCO or referred to the behavioral health ASO for services; and (4) Inform the providers of the following enrollee appeal, grievance, and fair hearing procedures and time frames: (a) The enrollee's right to a State fair hearing, how to obtain a hearing, and representation rules at a hearing; (b) The enrollee's right to file appeals and grievances, and the enrollee's requirements and time frames for filing; (c) The availability of assistance in filing; (d) The toll-free numbers to file verbal appeals and grievances; (e) The enrollee's right to request continuation of benefits during an appeal or State fair hearing filing, and that if the MCO action is upheld in a hearing, the enrollee may be liable for the cost of any continued benefits; and (f) The provider's right to appeal, on the enrollee's behalf, the failure of the MCO to cover a service. B. An MCO shall ensure that its PCP and specialty care providers receive adequate information regarding the Medicaid Program to facilitate full compliance with all federal and State Medicaid requirements. The MCO shall: (1) Ensure that each PCP and specialty care provider receives, at the time they enter into a contract, a copy of the MCO's Medicaid requirements manual, and any other pertinent information; and (2) Provide each PCP and specialty care provider, on an ongoing basis as appropriate, with periodic updates of the materials required to be provided under §B(1) of this regulation. C. An MCO shall provide to each PCP an updated list of the PCP’s assigned enrollees monthly. #### Regulation .05 Access Standards: PCPs and MCO's Provider Network. *COMAR 10.67.05.05* A. Primary Care Provider (PCP). (1) An MCO shall assign each enrollee to a primary care provider who is: (a) Chosen by the enrollee from the MCO's panel of qualified providers; or (b) Chosen by the MCO from its panel of qualified providers if the enrollee has failed to choose a PCP. (2) An enrollee may request a change of PCP at any time if the PCP is within the recipient's current MCO's panel of providers. (3) With respect to enrollees younger than 21 years old, an MCO shall assign the enrollee to a PCP who is certified by the EPSDT program, unless the enrollee or the enrollee's parent, guardian, or caretaker, as appropriate, specifically requests assignment to a PCP who is not EPSDT-certified. (4) If the enrollee’s parent, guardian, or caretaker, as appropriate, chooses a non-EPSDT certified PCP in accordance to §A(3) of this regulation, within 30 days of enrollment, the MCO shall: (a) Notify the parent, guardian, or caretaker, by letter, that a non-EPSDT certified PCP has been chosen; and (b) Include in the notification an explanation of the: (i) EPSDT preventive screening services to which an enrollee is entitled according to the EPSDT periodicity schedule; (ii) Importance of accessing the EPSDT preventive screening services; and (iii) Process for requesting a change to an EPSDT-certified PCP to obtain preventive screening services. (5) An MCO may include, as appropriate, any of the following practitioners to serve as the primary care provider for an enrollee: (a) General practitioner; (b) Family practitioner; (c) Internist; (d) Pediatrician; (e) OB/GYN; (f) Physician assistant; (g) Certified nurse midwife; (h) Nurse practitioner certified in any of the following areas of specialization: (i) Adult; (ii) Pediatric; (iii) Geriatric; (iv) OB/GYN; (v) School nurse; or (vi) Family; and (i) A physician practicing in a specialty area other than those enumerated in §A(5)(b)—(e) of this regulation. (6) The enrollee's designated primary care provider (PCP) is the enrollee's primary coordinator of care. (7) For female enrollees, if the enrollee's PCP is not a women's health specialist, the MCO shall provide direct access, without the need for a referral, to a women's health specialist within the MCO's network for covered services necessary to provide women's routine and preventive health care services. B. Adequacy of Provider Network. (1) An MCO shall develop and maintain a complete network of adult and pediatric primary care, specialty care, ancillary service, vision, pharmacy, home health, and any other providers adequate to deliver the full scope of benefits as required by this chapter and COMAR 10.67.06. (2) An MCO shall clearly define and specify referral requirements to specialty and other providers. (3) An MCO shall require the PCP to maintain records of referral arrangements, and the feedback and outcomes of those referrals, within each enrollee's medical records. (4) An MCO shall maintain a list of its proposed and existing subcontracts with health care providers who are necessary to fulfill the MCO's service delivery obligations. (5) An MCO shall provide a list of its subcontractor providers to the Department. (6) An MCO shall ensure services are delivered in a culturally competent manner to all enrollees, including enrollees: (a) With limited English proficiency; (b) With diverse cultural and ethnic backgrounds; and (c) Of all genders, sexual orientations, and gender identities. (7) For enrollees with physical or mental disabilities, an MCO shall ensure its network providers provide: (a) Physical access; (b) Reasonable accommodation; and (c) Accessible equipment. (8) Capacity. (a) MCOs shall ensure adequate capacity and services, in compliance with 42 CFR §438.206(b)(1)(i), as amended. (b) The Department shall assess the MCO's provider network and determine its capacity to serve waiver-eligible recipients in each local access area in its service area. (c) Unless the MCO can establish to the Department's satisfaction the adequacy of a higher ratio, the Department shall determine the MCO's capacity with respect to any local access area by assuming that in-plan individual practitioners, based on full-time equivalency, will be assigned no more than the number of enrollees that is consistent with a 200:1 ratio of enrollee to practitioner in the local access area. (d) The Department may not approve an enrollee-to-PCP ratio that is higher than 2,000:1. (9) To ensure compliance with the timely access requirements in Regulation .07 of this chapter, an MCO shall: (a) Establish mechanisms to ensure that network providers comply with access requirements; (b) Monitor regularly to determine compliance; and (c) Take corrective action if there is a failure to comply. #### Regulation .05-1 Access Standards: Specialty Provider Network. *COMAR 10.67.05.05-1* A. Standards and Regions. (1) The Department shall review an MCOs specialty provider network for MCOs overall network as defined in this regulation. (2) Overall Network Standards. (a) An MCO shall meet either the time or distance standard set forth in Regulation .06A of this chapter for core, major, and pediatric specialties. (b) The nine core specialties are: (i) Cardiology; (ii) Otolaryngology (ENT); (iii) Gastroenterology; (iv) Neurology; (v) Oncology; (vi) Ophthalmology; (vii) Orthopedics; (viii) Surgery; and (ix) Urology. (c) The 6 major specialties are: (i) Allergy and immunology; (ii) Dermatology; (iii) Endocrinology; (iv) Infectious disease; (v) Nephrology; and (vi) Pulmonology. (d) The 4 pediatric subspecialties are: (i) Cardiology; (ii) Gastroenterology; (iii) Neurology; and (iv) Surgery. B. If the Department determines that an MCO does not meet the requirements specified in §A(2)(b)(d) of this regulation, the MCO may provide additional information to support the adequacy of the MCO's specialty network before any action is taken by the Department. C. If an MCO fails to meet the requirements established by this regulation, the Department may suspend the automatic assignment to the MCO of recipients who live in the affected local access area. #### Regulation .06 Geographical Access. *COMAR 10.67.05.06* A. Except as provided in §C of this regulation, an MCO shall develop and maintain a provider network that meets the following time and distance standards: (1) For adult and pediatric primary care, pharmacy, diagnostic laboratory and x-ray, and gynecology: (a) In urban areas, within 15 minutes or 10 miles; (b) In suburban areas, within 30 minutes or 20 miles; and (c) In rural areas, within 40 minutes or 30 miles; (2) For prenatal care, as defined in §B of this regulation: (a) In urban areas, within 15 minutes or 10 miles; (b) In suburban areas, within 30 minutes or 20 miles; and (c) In rural areas, within 90 minutes or 75 miles; (3) For acute inpatient hospitals: (a) In urban areas, within 20 minutes or 10 miles; (b) In suburban areas, within 45 minutes or 30 miles; and (c) In rural areas, within 75 minutes or 60 miles; (4) For core specialty types, as defined in Regulation .05-1A(2)(b) of this chapter: (a) In urban areas, within 30 minutes or 15 miles; (b) In suburban areas, within 60 minutes or 45 miles; and (c) In rural areas, within 90 minutes or 75 miles; (5) For major specialty types, as defined in Regulation .05-1A(2)(c) of this chapter: (a) In urban areas, within 30 minutes or 15 miles; (b) In suburban areas, within 80 minutes or 60 miles; and (c) In rural areas, within 110 minutes or 90 miles; and (6) For pediatric subspecialty types, as defined in Regulation .05-1A(2)(d) of this chapter: (a) In urban areas, within 30 minutes or 15 miles; (b) In suburban areas, within 80 minutes or 60 miles; and (c) In rural areas, within 250 minutes or 200 miles. B. Prenatal Care Providers. For the purposes of provider network adequacy, prenatal care providers may include, but are not limited to: (1) Obstetricians; (2) Certified nurse midwives; and (3) Family practitioners who provide prenatal care and perform deliveries. C. If an MCO can otherwise demonstrate to the Department's satisfaction the adequacy of its provider network notwithstanding its inability to meet the requirements of §A of this regulation, the Department may, in its discretion, approve the network if special circumstances exist which, considered along with the overall strength of the MCO's network, establish that the Department's approval of the network will enhance recipients' overall access to quality health care services in the area to be served. D. Geographical Access: Local Access Areas. E. For purposes of this regulation: (1) Urban enrollment area includes Baltimore City; (2) Rural enrollment counties include: (a) Allegany; (b) Calvert; (c) Caroline; (d) Cecil; (e) Charles; (f) Dorchester; (g) Frederick; (h) Garrett; (i) Kent; (j) Queen Anne's; (k) Saint Mary's; (l) Somerset; (m) Talbot; (n) Washington; (o) Wicomico; and (p) Worcester; and (3) Suburban enrollment counties include: (a) Baltimore County; (b) Anne Arundel; (c) Carroll; (d) Harford; (e) Howard; (f) Montgomery; and (g) Prince George’s. #### Regulation .07 Access Standards: Clinical and Pharmacy Access. *COMAR 10.67.05.07* A. Appointments. (1) New Enrollees: Initial Appointment. (a) On its receipt and review of the health service needs information of a new enrollee, an MCO shall take appropriate action to ensure that the new enrollee who needs special or immediate health care services, as identified by the health service needs information, receives them in a timely manner. (b) Unless the new enrollee is assigned to a PCP who was the enrollee’s established provider of care immediately before the enrollee’s enrollment, and, consistent with any applicable periodicity schedule, the PCP concludes that no immediate initial appointment is necessary: (i) Unless a shorter time frame otherwise applies, the MCO shall ensure that a new enrollee's initial appointment is scheduled to occur within 90 days of the date of enrollment; (ii) Unless the PCP confirms that the enrollee has elected to continue prenatal care with her established provider pursuant to COMAR 10.67.06.28C, the MCO shall ensure that an initial prenatal appointment is scheduled to occur within 10 days of the date that the MCO receives the enrollee's completed health risk assessment, or within 10 days of the enrollee's request for an appointment, whichever is sooner; (iii) If the new enrollee is a person requesting family planning services, the MCO shall ensure that an initial appointment is scheduled to occur within 10 days of the date of the enrollee's request for an appointment; or (iv) If the new enrollee is identified to be at high risk by the health service needs information form, the MCO shall ensure that an initial appointment is scheduled to occur within 15 business days of the MCO’s receipt of the enrollee’s completed health risk assessment. (2) Required Notice to Enrollees of Wellness Services. (a) An MCO shall notify its enrollees in writing of their due dates for obtaining wellness services, including but not limited to immunizations and examinations, in a timely manner. (b) An MCO shall perform the notice required in §A(2)(a) of this regulation within 90 days of a new enrollee's enrollment. (3) Appointment Guidelines. (a) An MCO shall develop specific guidelines that define how requests for appointments are arranged, which shall include a policy that: (i) On request, all family members needing appointments will be given appointment times that are approximately concurrent or consecutive, whenever practicable, to facilitate the enrollees' transportation to and from their appointments; and (ii) When needed, enrollees will be afforded assistance in securing transportation to and from appointments, which shall include, when appropriate, contacting the local transportation grantee agency on behalf of the enrollee for the purpose of securing the enrollee's access to these services. (b) An MCO shall have procedures that result in an interval between the enrollee's request for an appointment and the actual appointment time being consistent with the following standards: (i) When §A(3)(b)(i) of this regulation does not apply, well-child assessments shall be scheduled to be completed within 30 days of the request for an appointment; (ii) Initial assessments of pregnant and postpartum women and individuals requesting family planning services shall be scheduled to be completed within 10 business days of the request for an appointment; (iii) Individuals requesting urgent care shall be scheduled to be seen within 48 hours of the request; (iv) Requests for routine and preventative primary care appointments shall be scheduled to be performed within 30 days of the request; (v) Requests for routine specialist follow-up appointments shall be scheduled to be performed within 30 days of the initial authorization from the enrollee's primary care provider, or sooner as deemed necessary by the primary care provider, whose office staff shall make the appointment directly with the specialist's office; (vi) At the discretion of the newborn's PCP, the initial visit for newborns shall be scheduled to be performed within 14 days of discharge from the hospital if no home visit has occurred; (vii) If a home visit has been provided, the initial visit for newborns shall be scheduled to be performed, at the discretion of the newborn's PCP, within 30 days of discharge from the hospital; and (viii) Requests for regular optometry, lab, and X-ray appointments shall be scheduled to be performed within 30 days of the request, and within 48 hours of the request for urgent care. B. An MCO shall respond in a timely manner to its enrollees' needs and requests, as follows: (1) If the enrollee arrives early or on time for a scheduled appointment, waiting time to be seen for a regular office visit may not exceed 1 hour after the scheduled appointment time; (2) An MCO representative may not leave an enrollee's telephone call on hold for more than 10 minutes; and (3) An MCO representative shall respond to patient inquiries as to whether or not to use emergency facilities within 30 minutes. C. Hours of Access for Clinical Services. (1) An MCO shall establish, or require its subcontractors to establish, a reasonable schedule of operating hours during which its service delivery sites are open to the MCO's enrollees as follows: (a) For the MCO's employee and subcontractor providers who are individual practitioners, operating hours shall be at least 20 hours per week and at least 3 days per week; (b) For subcontractors who have contracted with the MCO as a group practice or facility, the operating hours shall be at least 35 hours per week; (c) The distribution of the hours of service shall be consistent with enrollee utilization patterns, but is otherwise at the discretion of the MCO or its subcontractor; and (d) The operating hours may not be less than: (i) The hours of operation offered to commercial enrollees; or (ii) The hours of operation offered to Medicaid fee-for-service, if the provider serves only Medicaid enrollees. (2) Hours of Access for Pharmacy Services. (a) An MCO shall establish reasonable hours of access to pharmacy services, including weekend and evening hours, which are equivalent to the hours pharmacy services are generally available in the local access area to the public at large. (b) If the MCO determines that weekend and evening pharmacy hours are not generally available in the local access area, it may request approval from the Department to offer only limited pharmacy hours as specified in §C(2)(c) of this regulation. (c) To seek approval to offer limited pharmacy hours, an MCO shall make its request for approval to the Department, and shall include the following: (i) A specification of the geographical areas where the MCO intends to have limited pharmacy hours; (ii) An explanation of why only limited pharmacy hours are available in these areas; and (iii) An identification of where its enrollees would have to go to secure prescriptions in the evenings and on weekends. (d) Except as permitted in §C(2)(e) of this regulation, an MCO shall ensure that an enrollee receives at the time the prescription is dispensed to the enrollee any medically necessary disposable medical supplies or durable medical equipment needed by the enrollee to administer or monitor the enrollee's prescriptions. (e) An MCO shall ensure that any disposable supplies or durable medical equipment necessary to administer or monitor an enrollee's prescriptions, if not available at the pharmacy at the time of the dispensing of the prescription, is received in a manner so as not to adversely affect the health of the enrollee, but not later than 24 hours. D. Clinical Access Outside the MCO's Service Area. (1) Subject to §D(2) of this regulation, an MCO shall be financially responsible for medically necessary emergency services delivered to its enrollees outside of the MCO's service area. (2) With the exception of emergency services, an MCO may require authorization before treatment for services delivered to its enrollees outside of the MCO's service area. (3) If the MCO’s provider network is unable to provide necessary services, covered under the contract, to an enrollee, the MCO shall adequately and timely cover these services out of network for as long as the MCO’s provider network is unable to provide them. E. The Department may not impose any fines or other sanctions against an MCO for failure to comply with the waiting time standards in §B of this regulation unless there is evidence of a pattern of repeated violations by the MCO. #### Regulation .08 Emergency Services Access. *COMAR 10.67.05.08* A. An MCO shall develop and maintain policies and procedures for the adequate provision of emergency services for all its enrollees, including: (1) Instituting and monitoring a system for responding to enrollees' emergency medical conditions, with provisions for immediate attention to and appropriate disposition of emergency calls; and (2) Informing and educating its enrollees in the procedures to be followed in the event of an emergency, whether within or outside of the MCO's service area. B. An MCO shall provide medically necessary emergency services 24 hours per day, 7 days per week. C. An MCO shall maintain an emergency telephone service, with a physician on call, for the purpose of rendering medical advice and authorizing care at other facilities when use of the MCO's own facilities is impractical. D. An MCO may provide emergency services access through adequate and appropriate triage assessments performed by qualified medical professionals. E. An MCO shall utilize the trauma triage and transfer protocols established through the Maryland Institute for Emergency Medical Services Systems (MIEMSS) as the basis for directing the severely injured enrollee to the most appropriate level designated trauma center. F. An MCO shall reimburse, within 30 days of invoice, the undisputed claims of hospital emergency facilities and providers for the following services provided to the MCO's enrollees: (1) Emergency services, as defined in COMAR 10.67.01.01B; (2) Medical screening services based on the federal Emergency Medical Treatment and Active Labor Act (EMTALA); (3) If the MCO authorized, referred, or otherwise instructed the enrollee to use the emergency facility, medically necessary services that are related to the emergency condition, including poststabilization services; and (4) If the MCO fails to provide 24 hour access to a physician, medically necessary services that relate to the condition presented and that are provided by the provider in an emergency facility to the enrollee. G. Poststabilization Services. The MCO may not require preapproval of, and is financially responsible for, poststabilization services obtained in or outside of the MCO's network and administered to maintain, improve, or resolve the enrollee's stabilized condition if: (1) The MCO does not respond to a request for a preapproval within 1 hour; (2) The MCO cannot be contacted; or (3) The MCO representative and the treating physician cannot reach an agreement concerning the enrollee's care, and an MCO physician is not available for consultation, in which case: (a) The MCO shall give the treating physician the opportunity to consult with an MCO physician; and (b) The treating physician may continue care of the patient until a plan is reached or one of the following criteria is met: (i) An MCO physician with privileges at the treating hospital assumes responsibility for the enrollee's care; (ii) An MCO physician assumes responsibility for the enrollee's care through transfer; (iii) An MCO representative and the treating physician reach an agreement concerning the enrollee's care; or (iv) The enrollee is discharged. H. An MCO may require that any continuing care be obtained from the MCO's providers or from providers approved by the MCO when the following conditions are satisfied: (1) The enrollee's medical condition is appropriately stabilized and permits transferring responsibility for the enrollee's care, without medically harmful consequences, to these providers; and (2) The transfer is consistent with the requirements of the federal Emergency Medical Treatment and Active Labor Act (EMTALA). #### Regulation .09 Access: Hospitals. *COMAR 10.67.05.09* A. An MCO shall comply with the access standards specified in Regulation .06A of this chapter. B. If an MCO’s service area includes a county that is designated as a medically underserved area and there is only one hospital in the county, the MCO shall include the hospital in its network. ### Chapter 06 — Maryland Medicaid Managed Care Program: Benefits **Authority:** Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.30 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .01 amended effective December 27, 2010 (37:26 Md. R. 1787); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .01A amended effective November 6, 2006 (33:22 Md. R. 1732); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .01B amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .01C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .01C amended effective August 16, 2004 (31:16 Md. R. 1255) **Administrative History:** Regulations .01D, .04, .06, .07B, .10, .13, .21A, and .28 amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .01D amended effective December 19, 2005 (32:25 Md. R. 1941); October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .01G adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .02 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .03A amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .03A amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .04 amended effective December 25, 2000 (27:25 Md. R. 2281); February 18, 2002 (29:3 Md. R. 220); February 16, 2015 (42:3 Md. R. 316); February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .04A, C amended effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .04A, D amended effective November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .04C amended effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .04D amended effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .04G, H adopted effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .05 amended effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .05A amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .06 amended as an emergency provision effective December 1, 1999 (26:25 Md. R. 1888); amended permanently effective December 25, 2000 (27:25 Md. R. 2281) **Administrative History:** Regulation .06 repealed effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .06A amended effective February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) **Administrative History:** Regulations .07, .09, .10, and .27 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1151); emergency status expired December 31, 1997 **Administrative History:** Regulation .06 adopted effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .07 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .07B amended effective December 24, 2012 (39:25 Md. R. 1613); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .07F adopted effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .07F amended effective April 10, 2006 (33:73 Md. R. 668) **Administrative History:** Regulation .07G adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .07H adopted as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .07I adopted effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .08 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .09 amended effective February 9, 1998 (25:3 Md. R. 144); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .10 amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .10 repealed effective February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .10A amended effective February 2, 2004 (31:2 Md. R. 82); November 6, 2006 (33:22 Md. R. 1732); April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .10C amended as an emergency provision effective February 11, 2004 (31:5 Md. R. 445); amended permanently effective April 12, 2004 (31:7 Md. R. 584) **Administrative History:** Regulation .10C repealed effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .11 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .11B amended as an emergency provision effective July 1, 2002 (29:15 Md. R. 1139); amended permanently effective October 28, 2002 (29:21 Md. R. 1645) **Administrative History:** Regulation .11B amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .12 amended effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .12 amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .12 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .12 amended effective November 6, 2006 (33:22 Md. R. 1732); December 27, 2010 (37:26 Md. R. 1787); December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775); February 16, 2015 (42:3 Md. R. 316); February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .13A amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .13D adopted effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .14A, C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .14C amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .15 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .15 amended effective November 6, 2006 (33:22 Md. R. 1732); November 7, 2016 (43:22 Md. R. 1221) **Administrative History:** Regulation .16 amended effective December 23, 2002 (29:25 Md. R. 1981); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .17 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .18 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .19 amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); February 26, 2018 (45:4 Md. R. 205); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .20A amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .20B amended effective February 9, 1998 (25:3 Md. R. 144); February 18, 2002 (29:3 Md. R. 220); April 10, 2006 (33:7 Md. R. 668); December 24, 2012 (39:25 Md. R. 1613); April 28, 2014 (41:8 Md. R. 471); February 27, 2017 (44:4 Md. R. 252); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .21A amended effective November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulation .21D amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .22 amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .23 amended effective February 18, 2002 (29:3 Md. R. 220); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .24 amended effective October 28, 2013 (40:21 Md. R. 1775); August 26, 2019 (46:17 Md. R. 726) **Administrative History:** Regulation .24A, C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .24C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .25 amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .26 amended effective November 6, 2006 (33:22 Md. R. 1732); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .26-1 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .26-2 adopted as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); adopted permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .26-3 adopted effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulation .26-4 adopted effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .26-5 adopted effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .27 amended effective December 24, 2012 (39:25 Md. R. 1613); October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .27A amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .27B amended effective February 9, 1998 (25:3 Md. R. 144) **Administrative History:** Regulation .27B amended as an emergency provision effective March 9, 1998 (25:7 Md. R. 525); amended permanently effective June 15, 1998 (25:12 Md. R. 947) **Administrative History:** Regulation .27B amended effective November 1, 1999 (26:22 Md. R. 1692); December 25, 2000 (27:25 Md. R. 2281); December 23, 2002 (29:25 Md. R. 1981); February 2, 2004 (31:2 Md. R. 82); December 20, 2004 (31:25 Md. R. 1790) **Administrative History:** Regulation .27B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .27B amended effective April 10, 2006 (33:73 Md. R. 668); November 6, 2006 (33:22 Md. R. 1732); November 5, 2007 (34:22 Md. R. 1977); June 30, 2008 (35:13 Md. R. 1180); April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316) **Administrative History:** Regulation .28 amended effective April 19, 2010 (37:8 Md. R. 615); February 16, 2015 (42:3 Md. R. 316); April 10, 2017 (44:7 Md. R. 355) **Administrative History:** Regulation .28D amended effective February 6, 2012 (39:2 Md. R. 141) **Administrative History:** Regulation .28G amended effective November 6, 2006 (33:22 Md. R. 1732); April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .28H repealed effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .28H adopted effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .28H amended effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .28I adopted effective April 9, 2007 (34:7 Md. R. 698) **Administrative History:** Regulation .28I, J amended effective October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .28K adopted effective October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .29E—G adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .30 repealed effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .31 adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Chapter transferred from COMAR 10.09.67 effective November 1, 2019 (46:22 Md. R. 977) **Administrative History:** Regulation .04 amended effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .21A amended effective February 21, 2022 (49:4 Md. R. 300) **Administrative History:** Regulation .26 amended effective August 5, 2024 (51:15 Md. R, 707) **Administrative History:** Regulation .26-1 amended effective June 24, 2024 (51:12 Md. R. 620) **Administrative History:** Regulation .26-3 amended effective June 24, 2024 (51:12 Md. R. 620) **Administrative History:** Regulation .26-6 adopted effective May 1, 2023 (50:8 Md. R. 337) **Administrative History:** Regulation .26-7 adopted effective November 13, 2023 (50:22 Md. R. 974) **Administrative History:** Regulation .27 amended effective June 24, 2024 (51:12 Md. R. 620) **Administrative History:** Regulation .27A amended effective April 28, 2025 (52:8 Md. R. 359) **Administrative History:** Regulation .28A amended effective June 24, 2024 (51:12 Md. R. 618) **Administrative History:** Regulation .30 adopted effective June 24, 2024 (51:12 Md. R. 620) #### Regulation .01 Required Benefits Package — In General. *COMAR 10.67.06.01* A. Except for non-covered services set forth in Regulation .27 of this chapter and the non-capitated services described in COMAR 10.67.08, an MCO shall provide its enrollees with a benefits package that includes the covered services specified in this chapter when these services are deemed to be medically necessary including services covered under the Maryland Medicaid State Plan in the amount, duration, and scope set forth in the State Plan and in accordance with 42 CFR §440.230. B. An MCO shall ensure that the services provided are sufficient in amount, duration, or scope to reasonably achieve the purpose for which the services are furnished. C. An MCO is not required to provide non-covered services even when the service is medically necessary. D. Any limitations set forth in this chapter on covered services are not applicable to services required by enrollees who are younger than 21 years old when it is shown that the services are medically necessary to correct or lessen health problems detected or suspected by EPSDT screening services, as described in Regulation .20 of this chapter. E. An MCO may place appropriate limits on a service on the basis of criteria applied under the State plan, such as medical necessity. F. Cost Sharing and Prohibitions. (1) Except for the following, an MCO may not charge its enrollees any copayments, premiums, or cost sharing: (a) Up to a $3 copayment for brand-name drugs; (b) Up to a $1 copayment for generic drugs; (c) Any other charge up to fee-for-service limits as approved by the Department. (2) An MCO may not: (a) Deny services to an individual who is eligible for services because of the individual's inability to pay the cost sharing; (b) Impose copayments for the following: (i) Family planning services and supplies; (ii) Individuals younger than 21 years old; (iii) Pregnant women; (iv) Institutionalized individuals who are inpatients in long-term care facilities or other institutions; and (v) Emergency services. (c) Arbitrarily deny or reduce the amount, duration, or scope of a required service solely because of diagnosis, type of illness, or condition of the enrollee. G. An MCO shall ensure that all health care services provided under this chapter are performed, to the extent required by law, by an appropriate health care provider who is licensed, certified, or otherwise legally authorized to practice or deliver the services in the state in which the service is provided. H. An MCO shall provide for a second opinion from a qualified health care professional within the network, or, if necessary, arrange for the enrollee to obtain one outside the MCO network. #### Regulation .02 Benefits — Primary Care Services. *COMAR 10.67.06.02* An MCO shall provide to its enrollees medically necessary primary care services that are provided: A. By the enrollee's PCP; B. At the direction of the enrollee's PCP; or C. With respect to a primary care service that is self-referred pursuant to Regulation .28 of this chapter: (1) By an appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience; or (2) By a clinic that furnishes health care services by or under the direction of a physician. #### Regulation .03 Benefits — Physician and Advanced Practice Nurse Specialty Care Services. *COMAR 10.67.06.03* A. An MCO shall provide to its enrollees medically necessary specialty care services that are outside of the enrollee's PCP's scope of practice, or, in the judgment of the enrollee's PCP, are not services that the PCP customarily provides, is specifically trained for, or is experienced in and are provided by: (1) A physician or an advanced practice nurse, acting within the scope of the individual's license or certification, training, and experience; (2) A practitioner other than a physician or an advanced practice nurse when the practitioner is in a physician's employ, is under the physician's direct supervision, and performs the service within the scope of the practitioner's license, certification, or other legal authorization, for the purpose of assisting in the provision of the specialty care service; (3) A clinic that furnishes health care services by or under the direction of a physician; or (4) For enrollees who are younger than 21 years old, a doctor of dental medicine or dental surgery, if the services are surgical services that are also typically performed by physicians. B. Notwithstanding §A(2) of this regulation, specialty care services provided under Regulations .04—.25 of this chapter may include medically necessary diagnostic and treatment services provided by a physician or other appropriate practitioner, acting within the scope of the practitioner's license, certification, or other legal authorization, and in accordance with the practitioner's training and experience. #### Regulation .04 Benefits — Pharmacy Services. *COMAR 10.67.06.04* A. An MCO shall provide outpatient drugs as defined in §1927(k)(2) of the Social Security Act. B. An MCO shall provide to its enrollees all medically necessary pharmaceutical services and pharmaceutical counseling, including but not limited to: (1) Legend drugs; (2) Insulin; (3) All FDA approved contraceptives; (4) Hypodermic needles and syringes; (5) Enteral nutritional and supplemental vitamins and mineral products given by nasogastric, jejunostomy, or gastrostomy tube in the home; (6) Enteric coated aspirin prescribed for the treatment of arthritic conditions; (7) Nonlegend ferrous sulfate oral preparations; (8) Nonlegend chewable tablets of any ferrous salt when combined with vitamin C, multivitamins, multivitamins and minerals, or other minerals in the formulation when the enrollee is younger than 12 years old; (9) Medical supplies used in the preparation of compounded prescriptions for home intravenous therapy; (10) Medical supplies or equipment used in the administration or monitoring of medication prescribed or ordered for an enrollee by a qualifying provider as specified in §B of this regulation; (11) Latex condoms; (12) Nonlegend ergocalciferol liquid (Vitamin D); and (13) Emergency contraceptives for female recipients. C. Except as provided in §B of this regulation, an MCO is required to provide only those drugs and related pharmaceutical products that are prescribed or ordered by: (1) An MCO provider; (2) An out-of-plan provider, when the pharmacy services are ordered or prescribed in connection with medical care furnished by the provider to the MCO's enrollee: (a) In response to the enrollee's emergency medical condition; or (b) Pursuant to the enrollee's self-referral to the provider, when the care delivered qualifies as a permissible self-referred service under Regulation .28 of this chapter; or (3) A behavioral health provider for drugs not in the behavioral health formulary. D. An MCO shall provide over-the-counter emergency contraceptives and latex condoms to enrollees without requiring an order from an authorized prescriber. E. An MCO shall provide coverage for the following when performed by a pharmacist: (1) Contraceptive services, as follows: (a) A patient assessment performed at the pharmacist’s practice location in order to determine: (i) Whether to prescribe contraceptives; and (ii) Which contraceptive options to prescribe; and (b) If contraceptives are prescribed, a referral: (i) To the participant’s primary care practitioner or reproductive health care practitioner; or (ii) If the participant does not have a primary care practitioner or a reproductive health care practitioner, to a family planning provider or a licensed clinician who provides reproductive health care services. (2) Administration of: (a) Injectable medications for the treatment of sexually transmitted infection; and (b) Maintenance injectables medications. F. Drug Formulary. (1) An MCO shall establish and maintain a drug formulary that is at least equivalent to the standard therapies of the Maryland Medical Assistance Program, and include at a minimum: (a) Covered generic and name brand medications; and (b) The tier each medication is on. (2) An MCO shall include in its formulary drugs that are appropriate for medical management, safe, and effective. (3) An MCO shall expand its formulary, as needed, to include drugs that are equivalent to new drugs approved by the federal Food and Drug Administration, and which are deemed to be appropriate, safe, and efficacious in the medical management of the MCO's enrollees. (4) An MCO shall include in its formulary the following drugs: (a) Leuprolide acetate; (b) Clonidine; (c) Guanfacine; (d) Medroxyprogesterone; and (e) Liothyronine. (5) To ensure that its formulary drugs are medically necessary, safe, and efficacious, an MCO shall: (a) Subject its formulary to a review process that is: (i) Established and conducted by the MCOs Pharmacy and Therapeutics Committee; (ii) Approved by the Department; and (iii) Coordinated with the formulary review process of the Specialty Mental Health Services delivery system; and (b) Submit its formulary for the review and approval of the Department, based upon the standards set forth in this regulation. (6) Unless approved by the Department, an MCO may not require or utilize prior authorization or step therapy criteria for coverage of formulary drugs if such prior authorization or step therapy requires a recipient to use a drug that is included in the behavioral health formulary. G. Any option for accessing pharmacy services by mail order may be implemented only at the request of the enrollee except for when the drug is a specialty drug as defined in §H of this regulation. H. In this regulation, the term specialty drug means: (1) A prescription drug that: (a) Is prescribed for an individual with a complex, chronic or rare medical condition; (b) Costs $600 or more for up to a 30-day supply; (c) Is not typically stocked at retail pharmacies; and (d) Requires a difficult or unusual process of delivery to the patient in the preparation, handling storage, inventory or distribution of the drug; or (2) Requires enhanced patient education, management, or support, beyond those required for traditional dispensing, before or after administration of the drug. I. . If an enrollee subsequently requests to use a retail pharmacy for specialty drugs the MCO may not limit the enrollee to the use of a mail order pharmacy. J. An MCO shall: (1) Establish and maintain a drug utilization review program; (2) Adhere to the minimum performance standards established by the Department for these programs, whenever used, including but not limited to standards for the following drug use management components: (a) Formulary management; (b) Generic substitution; (c) Therapeutic substitution; (d) Prior authorization that complies with the requirements of §1927(d)(5) of the Social Security Act; (e) Drug use evaluation (DUE); (f) Disease management; and (g) Pharmacy and Therapeutic Committee; (3) Establish procedures to distinguish drug utilization data for covered outpatient drugs that are subject to discounts under the 340B drug pricing program; and (4) Provide to the Department a detailed description of its drug utilization review program activities on an annual basis. K. The Department shall: (1) Review each MCO’s drug utilization review program annually; and (2) Notify an MCO annually if any of the standards established in §J(2) of this regulation have not been met. L. For any performance standard identified in §K(2) of this regulation, MCOs shall acknowledge any deficiencies within 30 days and correct any deficiencies within 90 days or be subject to sanctions listed in COMAR 10.67.10.01A and B. #### Regulation .05 Benefits — Home Health Services. *COMAR 10.67.06.05* A. Subject to the conditions specified in §B of this regulation, an MCO shall provide to its enrollees medically necessary home health services, including: (1) Skilled nursing services, including the supervisory visits required by §A(2) of this regulation; (2) Home health aide services, including biweekly supervisory visits by a registered nurse in the recipient's home, every second visit of which includes observations of the delivery of services by the aide to the enrollee; (3) Physical therapy services; (4) Occupational therapy services; (5) Speech pathology services; and (6) Medical supplies that are used during a home health visit. B. An MCO shall provide the home health services specified in §A of this regulation that are: (1) Certified by the enrollee's PCP or by the enrollee's attending physician to be required on a part-time, intermittent basis; and (2) Rendered in the enrollee's home. #### Regulation .06 Benefits — Habilitation Services for Medicaid Expansion Populations *COMAR 10.67.06.06* A. An MCO shall provide the following medically necessary habilitation services to enrollees eligible for Medical Assistance under §1902(a)(10)(A)(i)(VIII) of the Social Security Act: (1) Physical therapy; (2) Occupation therapy; and (3) Speech therapy. B. At a minimum, an MCO shall provide the services in hospital inpatient and outpatient departments and physical therapy in an outpatient community setting. #### Regulation .07 Benefits — Inpatient Hospital Services. *COMAR 10.67.06.07* A. An MCO shall provide to its enrollees medically necessary inpatient hospital services as specified in this regulation. B. Admission to Long-Term Care Facility. (1) An MCO shall provide to its enrollees medically necessary long-term care facility services for: (a) The first 90 continuous days following the enrollee's admission; and (b) Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department's determination that the admission is medically necessary as specified in §B(2) of this regulation. (2) For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary. (3) The Department’s determination as described in §B(2) of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day. (4) Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility. C. The Department shall render a determination with respect to the medical necessity of a stay in a long-term care facility as specified in §B of this regulation within 3 business days of receipt of a complete application from the MCO. D. Childbirth — Length of Stay and Home Visits. (1) Except as provided in §D(2) and (3) of this regulation, the criteria and standards used by an MCO in performing utilization review of hospital services related to maternity and newborn care, including length of stay, shall be in accordance with the medical criteria outlined in the Guidelines for Perinatal Care, which is incorporated by reference in COMAR 10.67.04.01. (2) Unless the enrollee decides, in consultation with her attending provider, that less time is needed for recovery, an MCO shall provide or reimburse the cost of hospitalization including at least the following length of stay for an enrollee recovering from childbirth: (a) 48 hours of inpatient hospitalization care following an uncomplicated vaginal delivery; or (b) 96 hours of inpatient hospitalization care following an uncomplicated cesarean section. (3) If the enrollee elects to be discharged earlier than the length of stay specified in §D(2) of this regulation, the MCO is required to provide a home visit or visits pursuant to Regulation .21B—D of this chapter. E. In addition to the mother's length of stay required to be afforded by §D(2) of this regulation, whenever a mother is required to remain hospitalized after childbirth for medical reasons and she requests that her newborn remain in the hospital while she is hospitalized, the MCO shall afford the newborn additional hospitalization while the mother remains hospitalized, for up to 4 days. F. If an enrollee is in the hospital at the time of disenrollment from the MCO, and remains eligible for Medical Assistance, the MCO is responsible for covering the remainder of that hospital admission following disenrollment. G. An MCO shall provide for a private hospital room when: (1) The enrollee's condition requires a need for isolation; or (2) The enrollee requires admission and only private rooms are available. H. Payment For Ancillary Services. (1) Effective January 1, 2009, an MCO shall pay for all medically necessary ancillary services provided on inpatient hospital days including those days for which the inpatient hospitalization is otherwise appropriately denied. (2) A denial of an inpatient ancillary service shall be based on the medical necessity of the specific ancillary service. (3) An MCO is not required to pay for ancillary services if the entire hospitalization in §H(1) of this regulation is appropriately denied. I. Transports between hospitals are covered by the MCO when: (1) A medically necessary covered service is not available at the hospital where an enrollee is being treated; and (2) The enrollee is not being discharged from the sending hospital. #### Regulation .08 Benefits — Outpatient Hospital Services. *COMAR 10.67.06.08* An MCO's benefits package shall include medically necessary outpatient hospital services. #### Regulation .09 Benefits — Transplants. *COMAR 10.67.06.09* An MCO shall provide to its enrollees medically necessary transplants. #### Regulation .10 Benefits — Substance Abuse Treatment Service — Repealed *COMAR 10.67.06.10* #### Regulation .11 Benefits — Diagnostic and Laboratory Services. *COMAR 10.67.06.11* An MCO shall provide to its enrollees medically necessary: A. Diagnostic services; and B. Laboratory services, performed by a provider who: (1) Is Clinical Laboratory Improvement Amendments (CLIA) certified; or (2) Has a waiver of a certificate registration along with a CLIA identification number. #### Regulation .12 Benefits — Long-Term Care Facility Services. *COMAR 10.67.06.12* A. An MCO shall provide to its enrollees medically necessary services in a chronic hospital, a chronic rehabilitation hospital, or a nursing facility for: (1) The first 90 continuous days following the enrollee's admission; and (2) Any days following the first 90 continuous days of an admission until the date the MCO has obtained the Department’s determination that the admission is medically necessary as specified in §C of this regulation. B. Acute care services provided within the first 90 days following an enrollee's admission to a long-term care facility do not constitute a break in calculating the 90 continuous day requirement if the enrollee is discharged from the hospital back to the long-term care facility. C. For any long-term care facility admission that is expected to result in a length of stay exceeding 90 days, an MCO or long-term care facility shall request a determination by the Department that the admission is medically necessary. D. The Department’s determination as described in §C of this regulation is only applicable if the enrollee is still in the long-term care facility on the 91st day. E. The Department shall render a determination with respect to the medical necessity of a stay in a nursing facility as specified in §C of this regulation within 3 business days of receipt of a complete application from the MCO. F. A determination by the Department that the admission is medically necessary does not relieve the MCO of the obligation to pay for the admission through the day on which the determination is made. G. An MCO shall use the Department’s criteria for determining medical necessity for the days described in §A(1) of this regulation. #### Regulation .13 Benefits — Disposable Medical Supplies and Durable Medical Equipment. *COMAR 10.67.06.13* A. An MCO shall provide to its enrollees medically necessary disposable medical supplies and durable medical equipment, including but not limited to: (1) All supplies and equipment used in the administration or monitoring of prescriptions by the enrollees; (2) Incontinency pants and disposable underpads for medical conditions associated with prolonged urinary or bowel incontinence if necessary to prevent institutionalization or infection; (3) Orthotic devices when medically necessary for use in the MCO enrollee’s home, school, or place of employment; (4) Prosthetic devices once annually when medically necessary: (a) For use in the enrollee’s home, school, or place of employment; or (b) For the purpose of performing physical activities, including running, biking, swimming, strength training, and other activities to maximize the whole-body health and lower or upper limb function of the enrollee; (5) Annual repairs to prosthetic devices covered under §A(4) of this regulation when: (a) Medically necessary; and (b) When the repair’s necessity is not due to misuse; (6) Replacement of prosthetic devices covered under §A(4)of this regulation when medically necessary as follows: (a) Once annually for devices less than 3 years old if the replacement is necessary for the following reasons: (i) Because of a change in the physiological condition of the patient; (ii) Unless necessitated by misuse, because of an irreparable change in the condition of the prosthesis or the component of the prosthetic device; or (iii) Unless necessitated by misuse, because the condition of the prosthetic device or the component of the prosthetic device requires repairs and the cost of the repairs would be more than 60 percent of the cost of replacing the prosthetic device or the component of the prosthetic device. (b) For devices more than 3 years old subject to §A(4) and (5) of this regulation. B. Except as required in §C(1), an MCO shall provide preauthorization within 72 hours for DMS/DME services and supplies that require preauthorization by the MCO. C. An MCO shall provide its enrollees the disposable medical supplies and durable medical equipment in a timely manner so as to not adversely affect the health of the enrollees, in accordance with the following: (1) For medical equipment or supplies, or both, when there is an urgent medical need such as to facilitate hospital discharge or when a potential exists for worsening of enrollee's condition, the MCO shall provide needed items within 24 hours of request; and (2) For all other requests for DMS/DME, the MCO shall provide these items within 7 days from the date of request unless the MCO can document to the Department that justification for additional time is necessary. D. An MCO is responsible for paying for any durable medical equipment authorized and ordered while the member is active with the MCO if: (1) The delivery of the item occurs within 90 days after the member's termination date from the MCO; and (2) The member remains a Medicaid recipient. #### Regulation .14 Benefits — Vision Care Services. *COMAR 10.67.06.14* A. An MCO shall provide to its enrollees medically necessary vision care services as specified in this regulation. B. For enrollees who are 21 years old or older, the MCO is responsible for providing at least one eye examination every 2 years. C. For its enrollees who are younger than 21 years old, the MCO is responsible for providing medically necessary vision services, including but not limited to: (1) At least one eye examination every year in addition to any vision screen performed as part of an EPSDT screen; (2) Eyeglasses, limited to one pair per year unless lost, stolen, broken, or no longer vision appropriate; and (3) Contact lenses, if medically necessary and if eyeglasses are not efficacious for the condition. #### Regulation .15 Benefits — Podiatry Services. *COMAR 10.67.06.15* A. An MCO shall provide for its enrollees medically necessary podiatry services. B. In addition to the services described in §A of this regulation, an MCO shall provide: (1) Diabetes care services specified in COMAR 10.67.06.24; and (2) Routine foot care for enrollees, 21 years old or older with vascular disease affecting the lower extremities. #### Regulation .16 Benefits — Outpatient Rehabilitative Services. *COMAR 10.67.06.16* An MCO shall provide to its enrollees medically necessary outpatient rehabilitative services, including but not limited to physical therapy for adult enrollees. #### Regulation .17 Benefits — Oxygen and Related Respiratory Equipment. *COMAR 10.67.06.17* An MCO shall provide to its enrollees medically necessary oxygen and related respiratory equipment services. #### Regulation .18 Benefits — Dialysis Services. *COMAR 10.67.06.18* An MCO shall provide to its enrollees medically necessary dialysis services. #### Regulation .19 Benefits — Family Planning Services. *COMAR 10.67.06.19* A. An MCO shall provide to its enrollees comprehensive family planning services, including but not limited to medically necessary office visits and laboratory tests, all FDA-approved contraceptive devices, methods, and supplies, and voluntary sterilizations. B. An MCO may place appropriate limits on family planning services for the purpose of utilization control, provided that the services are provided in a manner that protects and enables the enrollee’s freedom to choose the method of family planning to be used consistent with 42 CFR §441.20. C. An MCO may not apply a copayment or coinsurance requirement for contraceptive drugs or devices. D. An MCO shall provide coverage for a single dispensing of a supply of prescription contraceptives for a 12-month period. #### Regulation .20 Benefits — EPSDT Services. *COMAR 10.67.06.20* A. An MCO shall provide, to enrollees younger than 21 years old, medically necessary Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) services, including: (1) EPSDT comprehensive well-child services provided in accordance with the EPSDT periodicity schedule and performed by an EPSDT-certified provider, including: (a) A comprehensive health and developmental history, including an evaluation of both physical and mental health development; (b) A comprehensive unclothed physical exam; (c) Immunizations appropriate to age and health history; (d) Laboratory tests, including blood lead level assessment, as appropriate to age and risk; (e) Health education, including anticipatory guidance; and (f) Vision, hearing, and dental screening; (2) EPSDT partial or interperiodic well-child services; and (3) Health care services that are: (a) Necessary to prevent, treat, or ameliorate physical, mental, or developmental problems or conditions identified by an EPSDT-certified provider or other health professional; (b) Sufficient in amount, duration, and scope to treat the identified condition; and (c) Subject to limitation only on the basis of medical necessity. B. The health care services described in §A(3) of this regulation shall include, at a minimum, all services described in this chapter, and the following: (1) Chiropractic services; (2) Nutrition counseling services; (3) Private duty nursing services including: (a) An initial assessment and development of a plan of care by a registered nurse; and (b) On-going private duty nursing services delivered by a licensed practical nurse or a registered nurse; and (4) Durable medical equipment. C. An MCO shall provide referrals for services not covered by Medicaid, but which are furnished at little or no cost to recipients, including appropriate referrals to: (1) The Head Start Program; (2) The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); (3) School Health-Related Special Education Services; (4) Vocational Rehabilitation; and (5) Maternal and Child Health Services located at local health departments. #### Regulation .21 Benefits — Pregnancy-Related Services. *COMAR 10.67.06.21* A. An MCO shall provide to its pregnant and postpartum enrollees medically necessary pregnancy-related services, including: (1) Comprehensive prenatal, perinatal, and postpartum care, including high-risk specialty care when appropriate; (2) Prenatal risk assessment and development of an individualized plan of care that specifies the actions required to address each identified need and is appropriately modified during the course of care; (3) Enriched maternity services, including: (a) Prenatal and postpartum counseling and education; (b) Basic nutritional education; (c) Substance abuse treatment, as provided in Regulation .10 of this chapter; (d) Appropriate referrals to services that may improve the pregnancy outcome, including: (i) Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and (ii) Healthy Start services; (e) High-risk nutrition counseling services for nutritionally high-risk pregnant women; (f) Appropriate levels of inpatient care, including emergency transfer of pregnant women and newborns to tertiary care centers; (g) Smoking cessation education and treatment; (h) Doula services; and (i) Home visiting services. B. When an enrollee recovering from childbirth elects to be discharged before 48 hours following a normal vaginal delivery or 96 hours following an uncomplicated cesarean section, the MCO is responsible for providing: (1) One home visit scheduled to occur within 24 hours after discharge; and (2) An additional home visit as may be prescribed by the attending provider. C. When an enrollee recovering from childbirth and her newborn enrollee remain in the hospital for at least as long as the period of time provided under §B of this regulation, the MCO shall provide a home visit as prescribed by the attending provider. D. An MCO shall provide for home visits required by §§B and C of this regulation to be performed by a registered nurse and in accordance with generally accepted standards of nursing practice for home care of a mother and newborn child, including: (1) An evaluation of the presence of immediate problems of dehydration, sepsis, infection, jaundice, respiratory distress, cardiac distress, or other adverse physical symptoms of the infant; (2) An evaluation of the presence of immediate problems of dehydration, sepsis, infection, bleeding, pain, or other adverse symptoms of the mother; (3) Collection of a blood specimen for newborn screening if not previously completed; (4) Referrals for any medically necessary continuing health care services; and (5) Any other nursing services ordered by the referring provider. #### Regulation .22 Benefits — Case Management Services for HIV-Infected Individuals. *COMAR 10.67.06.22* An MCO shall provide medically necessary case management services to its qualifying enrollees, as specified in COMAR 10.67.04.10C. #### Regulation .23 Benefits — Hospice Care Services. *COMAR 10.67.06.23* A. An MCO shall include in its benefits package medically necessary hospice care services to enrollees who are terminally ill. B. The Department shall allow an enrollee to disenroll from an MCO and choose a new MCO if: (1) The enrollee was auto-assigned to the MCO; and (2) The enrollee's hospice provider does not contract with the enrollee's assigned MCO. C. If an enrollee who is in a hospice that does not contract with the enrollee's MCO and the enrollee will not voluntarily choose a new MCO, the enrollee's current MCO: (1) Shall authorize and pay the out-of-network hospice provider at the established Medicaid rate, to ensure continuity of care; and (2) May not require the hospice care enrollee to change their out-of-network hospice provider to an in-network hospice provider. #### Regulation .24 Benefits — Diabetes Prevention and Care Services. *COMAR 10.67.06.24* A. An MCO shall provide to its qualifying enrollees medically necessary diabetes prevention and care services as specified in this regulation. B. National Diabetes Prevention Program. (1) In addition to the services included in its usual benefits package, an MCO shall make available to its enrollees who meet the Centers for Disease Control and Prevention (CDC) eligibility criteria defined in §B(2) of this regulation the National Diabetes Prevention Program through a CDC-recognized lifestyle change organization. (2) To be eligible for participation in the National Diabetes Prevention Program, a HealthChoice enrollee: (a) Shall be 18 through 64 years old; (b) Shall be overweight or obese; (c) Shall have an elevated blood glucose level or a history of gestational diabetes mellitus; (d) May not have a previous diagnosis of type 1 or type 2 diabetes prior to enrollment; and (e) May not be currently pregnant. C. In addition to the services included in its usual benefits package, an MCO shall provide enrollees with a diabetes diagnosis the following medically necessary special diabetes-related services: (1) Diabetes nutrition counseling, consisting of one initial one-on-one session and up to 4 subsequent sessions annually; (2) Diabetes outpatient education; (3) Diabetes-related durable medical equipment, disposable medical supplies, and therapeutic footwear and related services, when ordered as medically necessary, including: (a) Therapeutic footwear, orthopedic shoes, arch supports, orthotic devices, in-shoe supports, elastic support, or examinations for prescription or fitting and related services to prevent or delay a foot amputation that would be highly probable in the absence of the specialized footwear; (b) Blood glucose monitoring supplies; (c) Diagnostic reagent strips and tablets used in testing for ketones and glucose in urine and glucose in blood; (d) Finger-sticking devices used in obtaining blood samples for blood glucose testing; and (e) Blood glucose reflectance meters for home use; (4) Routine foot care; and (5) Vision care consisting of: (a) One ophthalmologic examination per year; and (b) One pair of eyeglasses per year. #### Regulation .25 Benefits — Blood and Blood Products. *COMAR 10.67.06.25* An MCO shall provide to its enrollees medically necessary blood, blood products, derivatives, components, biologics, and serums to include autologous services, whole blood, red blood cells, platelets, plasma, immunoglobulin, and albumin. #### Regulation .26 Benefits — Primary Mental Health Services. *COMAR 10.67.06.26* A. An MCO shall provide to its enrollees medically necessary primary mental health services, including appropriate referrals for service to the Department’s behavioral health ASO as described in COMAR 10.09.59. B. Effective October 1, 2023, MCOs shall provide their enrollees medically necessary primary mental health services, including the Collaborative Care Model, pursuant to COMAR 10.09.64. #### Regulation .26-1 Clinical Trial Items and Services — Coverage for Routine Costs. *COMAR 10.67.06.26-1* A. Subject to the conditions specified in §§B—F of this regulation, an MCO shall provide coverage for cost to an enrollee in an approved clinical trial for: (1) Treatment provided for life-threatening conditions; or (2) Prevention, early detection, and treatment studies on cancer. B. Clinical trials are deemed to be automatically approved if: (1) The treatment is: (a) Being provided or the studies are being conducted in a Phase I, Phase II, Phase III, or Phase IV clinical trials for cancer; or (b) Being provided in Phase I, Phase II, Phase III, or Phase IV clinical trial for any other life-threatening condition; (2) The treatment is being provided in a clinical trial: (a) Approved by: (i) The National Institutes of Health (NIH); (ii) An NIH cooperative group or an NIH center; (iii) The Centers for Disease Control and Prevention; (iv) The Agency for Healthcare Research and Quality; (v) The Centers for Medicare and Medicaid Services (CMS); (vi) The Department of Defense; (vii) The Department of Veterans Affairs; or (viii) An institutional review board of an institution in the State that has a multiple project assurance contract approved by the Office of Protection from Research Risks of the NIH; or (b) Conducted: (i) At National Cancer Institute Centers; (ii) Under Investigational New Drug application (IND) reviewed by the Food and Drug Administration (FDA); or (iii) As a clinical trial with deemed status through an exemption from having an IND under 21 CFR §312.2(b)(1); (3) The facility and the personnel providing the treatment are capable of doing so by virtue of the facility and the personnel's experience, training, and volume of patients treated to maintain expertise; (4) There is no clearly superior, non-investigational treatment alternative; and (5) The available clinical or preclinical data provide a reasonable expectation that the treatment will be at least as effective as the non-investigational alternative. C. Enrollee cost includes the following: (1) The cost of all medically necessary items and services that are otherwise available to Medicaid beneficiaries such as hospital services, physician services, or diagnostic tests; and (2) The cost of medically necessary items or services required solely for the provision of the following: (a) Investigational item or service such as administration of a noncovered chemotherapeutic agent; (b) The clinically appropriate monitoring of the effects of the item or service; or (c) The prevention, diagnosis, and treatment of complications. D. Enrollee cost does not include the following: (1) The cost of the investigational item or service itself; (2) The cost of items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the enrollee; (3) The cost of items and services customarily provided by the research sponsors free of charge for any enrollee in the trial; and (4) The cost of non-health care services that an enrollee may be required to receive as a result of the treatment being provided for purposes of the clinical trial. E. If the enrollee has insurance or other coverage, or if any other person is obligated, either legally or contractually, to pay for, or to reimburse the enrollee for, services covered by this regulation, the provider shall seek payment from that source first. F. The MCO shall authorize the request for participation in an approved clinical trial within 72 hours of the request. #### Regulation .26-2 Plastic and Restorative Surgery. *COMAR 10.67.06.26-2* An MCO shall provide to an enrollee medically necessary surgery to correct a deformity from disease, trauma, congenital or developmental anomalies, or to restore body functions. #### Regulation .26-3 Gender- Affirming Treatment. *COMAR 10.67.06.26-3* A. An MCO shall provide medically necessary gender-affirming treatment services which include but are not limited to the following: (1) Hormone therapy, hormone blockers, and puberty blockers; (2) Hair alteration for the purposes of altering secondary sex characteristics and surgical site preparation; (3) Alterations to voice, voice therapy, and voice lessons; (4) Alterations to abdomen, chest, trunk, and buttocks; (5) Alterations to the face and neck; (6) Alterations to the genitals and gonads; (7) Laser treatment for scars from gender-affirming treatment; (8) Standard fertility preservation procedures as set forth in Insurance Article, §15-810.1, Annotated Code of Maryland; (9) Revisions to previous treatments and reversal of treatments; (10) Combinations of gender-affirming procedures; and (11) Other treatments as prescribed to suppress the development of endogenous secondary sex characteristics, align the individual’s appearance of physical body with gender identity, and alleviate symptoms of clinically significant distress resulting from gender dysphoria. B. An MCO may not issue an adverse benefit determination denying or limiting access to gender-affirming treatment unless a health care provider with experience prescribing or delivering gender-affirming treatment has reviewed and confirmed the appropriateness of the adverse benefit determination. #### Regulation .26-4 Audiology. *COMAR 10.67.06.26-4* An MCO shall provide enrollees medically necessary audiology services as described in COMAR 10.09.51, including: A. Hearing aids; B. Cochlear implants; C. Auditory osseointegrated devices; and D. Related services. #### Regulation .26-5 Remote Patient Monitoring. *COMAR 10.67.06.26-5* An MCO shall provide its enrollees medically necessary remote patient monitoring services as described in COMAR 10.09.96. #### Regulation .26-6 Mobile Integrated Health Services. *COMAR 10.67.06.26-6* An MCO shall provide its enrollees medically necessary mobile integrated health services as described in COMAR 10.09.31. #### Regulation .26-7 Social Determinants of Health. *COMAR 10.67.06.26-7* Subject to COMAR 10.09.63, an MCO shall provide coverage for community violence prevention. #### Regulation .27 Benefits — Limitations. *COMAR 10.67.06.27* A. The benefits or services not required to be provided by an MCO are as follows: (1) Experimental or investigational services, including organ transplants determined by Medicare to be experimental, except when an enrollee is participating in an authorized clinical trial as specified in Regulation .26-1 of this chapter; (2) Any service or treatment that is not medically necessary; (3) Services performed or prescribed under the direction of a person who is not a health care practitioner; (4) Services that are beyond the scope of practice of the health care practitioner performing the service; (5) Transportation services provided through grants to local governments pursuant to COMAR 10.09.19, other than assisting enrollees to access nonemergency transportation services through their local transportation grantee agency; (6) Health-related services and targeted case management services provided to children when the services are: (a) Specified in the enrollee's individualized family service plan (IFSP), or an individualized education program (IEP); and (b) Delivered in the schools or through Children's Medical Services community-based providers; (7) Autopsies; (8) Immunizations required for travel outside the continental United States; (9) Services received while the enrollee is outside the United States; (10) Abortions; (11) Diet and exercise programs for the loss of weight; (12) Prescriptions or injections for central nervous system stimulants and anorectic agents when used for controlling weight; (13) In vitro fertilization, ovum transplants and gamete intrafallopian tube transfer, zygote intrafallopian transfer, or other techniques used in these or similar procedures; (14) Services to reverse a voluntary sterilization procedure; (15) Lifestyle improvements, including smoking cessation, nutrition counseling, or physical fitness programs, unless specifically included as a covered service; (16) Nonmedical ancillary services such as vocational rehabilitation, employment counseling, or educational therapy; (17) Private duty nursing for adults 21 years old and older; (18) Services incurred before the effective date of coverage for an enrollee; (19) Dental or orthodontic care; (20) Piped-in oxygen or oxygen prescribed for standby purposes or on an as-needed basis; and (21) Cosmetic surgery when performed solely to maintain normal physical appearance or enhance beyond average level toward an aesthetic ideal. (22) Enteral nutritional and supplemental vitamins and mineral products when administered orally. B. An MCO is not required to provide any of the benefits or services which are reimbursed directly by the Department as described in COMAR 10.67.08. #### Regulation .28 Benefits — Self-Referral Services. *COMAR 10.67.06.28* A. An MCO shall be financially responsible for reimbursing, in accordance with COMAR 10.67.04.20, an out-of-plan provider chosen by the participant for the following services: (1) Family planning services specified in COMAR 10.67.04.20A(2), (6), and (7); (2) Services performed by school-based health centers (SBHCs), as provided in COMAR 10.09.76; (3) Pregnancy-related services for women who are pregnant and, at the time of initial enrollment, have received prenatal care during their current pregnancy from an out-of-plan provider, and this pre-enrollment care consists of at least the following: (a) A full prenatal examination; (b) A risk assessment; and (c) Appropriate laboratory services; (4) Initial medical examination for children in State custody when performed by an EPSDT certified provider; (5) One annual diagnostic and evaluation service (DES) visit for any enrollee diagnosed with HIV/AIDS, which the MCO is responsible for facilitating on the enrollee's behalf; (6) Renal dialysis services performed in a Medicare-certified facility; (7) Initial medical examination of a newborn when the: (a) Examination is performed in a hospital by an on-call physician; and (b) MCO failed to provide for the service before the newborn's discharge from the hospital; (8) Emergency services as described in COMAR 10.67.05.08B; (9) Prenatal, intrapartum, and postpartum services performed at a free-standing birth center located in Maryland or a contiguous state; and (10) Doula services, through December 31, 2025. B. An MCO shall pay undisputed claims of the SBHC for services provided to its participants within 30 days of the MCO's receipt of the invoice. C. An MCO shall provide SBHCs in its service area with the current information needed to facilitate communication between the SBHC, PCP, and the MCO regarding care provided to the MCO's participant, and to effect reimbursement by the MCO, including: (1) Information concerning the MCO's policies and procedures regarding the provision of pharmacy and laboratory services; (2) Instructions for submitting claims; and (3) Contact information, including names and phone numbers of the following individuals: (a) The MCO representative who serves as an SBHC's contact person for coordination of care; and (b) The student-participant's PCP. #### Regulation .29 Optional Services. *COMAR 10.67.06.29* A. An MCO may provide its enrollees with additional health care services that are not required by this chapter. B. Optional health care services that an applicant intends to include in its benefits package shall be specified, including the terms and conditions for, and limitations to the provision of these services, in the applicant's initial application to the Department, as well as for periodic Departmental review. C. An MCO's provision of optional services that it has represented to be available to its enrollees is subject to monitoring of complaints and consumer satisfaction surveys, and to random audits. D. An MCO's provision of additional services that are not required by this regulation may not be taken into account when setting the MCO's capitation rate. E. Effective January 1, 2015, any changes to the health care services being offered by the MCO under §A of this regulation, including reducing or waiving pharmacy co-pays, shall be effective for an entire calendar year. F. An MCO shall notify the Department of any changes to their optional services by September 15 for the following calendar year. G. The Department may waive the requirement under §E of this regulation if the Department determines that the circumstance warrant, including but not limited to a reduction in rates outside the normal rate setting process. #### Regulation .30 Fertility Preservation. *COMAR 10.67.06.30* A. An MCO shall provide medically necessary fertility preservation services for the following individuals: (1) Individuals who have iatrogenic infertility; (2) Individuals who are receiving medical treatment that may directly or indirectly cause iatrogenic infertility; or (3) Individuals who are receiving gender-affirming treatment. B. Fertility preservation services include sperm and oocyte cryopreservation and evaluations, laboratory assessments, medications, and treatments associated with sperm and oocyte cryopreservation. C. Fertility preservation services do not include the storage of sperm or oocytes. #### Regulation .31 Benefits — Telemedicine Services. *COMAR 10.67.06.31* An MCO shall provide to its enrollees medically necessary telemedicine services as described in COMAR 10.09.49. ### Chapter 07 — Maryland Medicaid Managed Care Program: Program Integrity **Authority:** Health-General Article, Title 15, Subtitle 1, Annotated Code of Maryland **Administrative History:** Effective date: February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .01L amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .01N adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred from COMAR 10.09.68 effective November 1, 2019 (46:22 Md. R. 977) #### Regulation .01 Requirements to Detect and Prevent Fraud, Waste, and Abuse. *COMAR 10.67.07.01* A. An MCO or its responsible subcontractor shall implement and maintain arrangements or procedures that are designed to detect and prevent fraud, waste, and abuse, which includes a compliance program that has, at a minimum, the following elements: (1) Written policies, procedures, and standards of conduct that include the MCO’s commitment to comply with all applicable: (a) Requirements and standards under the contract; and (b) Federal and State requirements including: (i) Written policies for all employees and those of any contractor or agent that provide detailed information about the False Claims Act and other Federal and State laws described in §1902(a)(68) of the Social Security Act; and (ii) Information about rights of employees to be protected as whistleblowers. (2) The designation of a compliance officer, who reports directly to the chief executive officer and the board of directors and is responsible for developing and implementing policies, procedures, and practices designed to ensure compliance with the requirements of the contract, and at minimum the following staff members: (a) An investigator who is responsible for fraud, waste, and abuse investigations; (b) An auditor who is responsible for identifying potential fraud, waste, and abuse through analysis of claims and related information; and (c) An analyst capable of reviewing data and codes who is responsible for reviewing and researching evidence of potential fraud, waste, and abuse. (3) Staffing and resources located in Maryland to identify and investigate potential fraud, waste, and abuse, which shall be based on criteria determined by the Department that may include but are not limited to: (a) Number of enrollees; (b) Number of claims received on an annual basis; (c) Volume of suspected fraudulent and abusive claims currently being detected; (d) Other factors relating to the vulnerability of the MCO to fraud and abuse; and (e) An assessment of optimal caseload which can be handled by an investigator on an annual basis. (4) The establishment of a regulatory compliance committee, which reports to the board of directors and to the MCO’s senior management level and is charged with overseeing the organization’s compliance program and its compliance with the requirements under the contract; (5) A system for training and educating the compliance officer, the organization’s senior management, and the organization’s employees regarding the federal and State standards and requirements under the contract; (6) Effective lines of communication between the compliance officer and the organization’s employees; (7) Enforcement of standards through well-publicized disciplinary guidelines; (8) Establishment and implementation of procedures and a system with dedicated staff for: (a) Routine internal monitoring and auditing of compliance risks; (b) Prompt response to compliance issues as they are raised; (c) Investigation of potential compliance problems as identified in the course of self-evaluation and audits; (d) Correction of problems, identified under §A(7)(c) of this regulation, promptly and thoroughly, or coordination of suspected criminal acts with law enforcement agencies, to reduce the potential for recurrence; and (e) Ongoing compliance with the requirements under the contract. B. An MCO shall ensure that a subcontractor is legally qualified to furnish the services provided for in the subcontract. C. An MCO may not contract with the State unless conflict of interest safeguards at least equal to federal safeguards under section 27 of 41 U.S.C. §423, as amended, are in place. D. An MCO may not knowingly have a relationship of the type described in §E of this regulation with the following: (1) An individual or entity that is debarred, suspended, or otherwise excluded from: (a) Participating in procurement activities under the Federal Acquisition Regulation; or (b) Participating in non-procurement activities under Executive Order Number 12549, 3 CFR 189 (1986); or (2) An individual or entity who is an affiliate, as defined in 48 CFR §2.101, of a person described in §D(1) of this regulation. E. The relationships described in §D of this Regulation, are as follows: (1) A director, officer, or partner of the MCO; (2) A subcontractor of the MCO; (3) A person with beneficial ownership of 5 percent or more of the MCO’s equity; or (4) A network provider or person with an employment, consulting or other arrangement with the MCO for the provision of items and services that is significant and material to the MCO’s obligations under its contract with the Department. F. An MCO may not have a relationship with an individual or entity that is excluded from participation in any Federal health care program under §1128 or 1128A of the Social Security Act. G. An MCO shall monitor the Department’s correspondence and any database publicizing Department-initiated terminations of providers from the Program. H. An MCO shall terminate the contract of, or refrain from contracting with, providers terminated or excluded from participation in the Program. I. An MCO shall suspend payments to a network provider for which the Department has determined that there is a credible allegation of fraud in accordance with 42 CFR §455.23. J. An MCO shall establish a system to verify, by sampling or other methods, whether services that have been represented to have been delivered by network providers were received by enrollees and shall apply such verification processes at least annually. K. An MCO shall require and have a mechanism for a network provider to report to the MCO when it has received an overpayment and to: (1) Return the overpayment to the MCO within 60 calendar days after the date on which the overpayment was identified; and (2) Notify the MCO in writing of the reason for the overpayment. L. Overpayments to Providers and Subcontractors. (1) Overpayments recovered by an MCO, including those recovered due to waste, fraud and abuse, may be retained by the MCO, so long as it is reported to the Department. (2) If the Department, Federal government, or its agents identified the potential fraud, waste, or abuse that leads to recovery of funds paid to an MCO provider, and the MCO did not previously identify and report the provider for potential overpayments, the State shall have the right to recover from the MCO the entire amount of the overpayment. (3) The State shall have the sole right of recovery of an overpayment when the MCO has identified the overpayment and the MCO has not initiated recovery within 90 days after the completion of the MCO’s investigation. (4) The MCO shall have the right to appeal, pursuant to COMAR 10.67.10.02, the Department’s recovery of an overpayment. M. The Department has the authority to recover any overpayments made to MCOs. N. An MCO shall ensure that all of its network providers are screened, enrolled, and revalidated by the State as Medicaid providers, in accordance with 42 CFR part 455, subparts B and E. #### Regulation .02 Access to Information. *COMAR 10.67.07.02* A. An MCO, its subcontractors, and its subcontractor’s subcontractors shall permit the following organizations or their designees to inspect, evaluate, or audit books, records, contracts, computer or other electronic systems, premises, and facilities that pertain to the MCO’s Medicaid enrollees, and any aspect of services and activities performed, or determination of amounts payable under, the MCO’s contract with the Department: (1) The Department and its agents; (2) The Medicaid Fraud Control Unit of the Office of the Attorney General; (3) The Insurance Fraud Division of the Maryland Insurance Administration; (4) The Centers for Medicare and Medicaid Services; (5) The Inspector General of the Department of Health and Human Services; (6) The Comptroller General; and (7) Other authorized State or federal agencies. B. The right to inspect, audit, and evaluate shall exist for 10 years from the final date of the contract period or from the completion of any audit, whichever is later, except, if the Department, Centers for Medicare and Medicaid Services, or the Department of Health and Human Services Inspector General determines that there is a reasonable possibility of fraud, or similar risk, those agencies may inspect, audit, and evaluate at any time. C. Notwithstanding §B of this regulation, the Department has the right to inspect the accuracy, truthfulness, and completeness of the encounter data submitted by, or on behalf of, the MCO. #### Regulation .03 Reporting. *COMAR 10.67.07.03* A. An MCO shall submit to the Department the following: (1) Encounter data in the form and manner described in COMAR 10.67.04.15B, 42 CFR §438.242(c), and 42 CFR §438.818. (2) Data required by the Department in order to certify the actuarial soundness of capitation rates to an MCO, under 42 CFR §438.3, including base data described in 42 CFR §438.5(c) that is generated by the MCO. (3) Data required by the Department to determine compliance of the MCO with the medical loss ratio requirement described in 42 CFR §438.8. (4) Data required by the Department and the Maryland Insurance Administration to determine that the MCO has made adequate provision against the risk of insolvency as required under 42 CFR §438.116. (5) Documentation described in 42 CFR §438.207(b) on which the Department bases its certification that the MCO has complied with the State’s requirements for availability and accessibility of services, including the adequacy of the provider network, as set forth in 42 CFR §438.206. (6) In accordance with §F of this regulation, information on ownership and control described in 42 CFR §455.104 from an MCO and its subcontractors, as governed by 42 CFR §438.230. (7) An annual report of overpayment recoveries as required in 42 CFR §438.608(d)(3). (8) Any other data, documentation, or information relating to the performance of the entity’s obligations under its contract with the Department, or required by the Department or the Secretary of the Department of Health and Human Services. B. An MCO shall report to the Department any identified inaccuracies in the encounter data reported by the MCO or its subcontractors within 30 days of the date discovered regardless of the effect which the inaccuracy has upon MCO reimbursement. C. An MCO shall promptly report to the Department’s Office of Inspector General (OIG) any potential fraud, waste, abuse, or information it has received from whistleblowers relating to the integrity of the MCO, its network providers, or its subcontractors. D. An MCO shall report any potential fraud directly to the Medicaid Fraud Control Unit and the Department’s OIG, including fraud by providers, employees and subcontractors of the MCO, enrollment agents, and enrollees. E. After reporting any potential fraud, waste, or abuse to the Department’s OIG and to the Medicaid Fraud Control Unit, the MCO may not take the following actions without prior written approval from the State: (1) Contact the subject of the investigation about any matter related to the investigation; (2) Enter into or attempt to negotiate any settlement or agreement regarding the incident; or (3) Accept any monetary or other type of consideration offered by the subject of the investigation in connection with the incident. F. For complaints of provider fraud and abuse that warrant a preliminary investigation, the MCO’s reports required in §§C and D of this regulation shall include: (1) The number of complaints; (2) The name and identification number of the provider being investigated; (3) The source of the complaint; (4) The type of provider; (5) The nature of the complaint; (6) The approximate dollar amount involved; (7) The legal and administrative disposition of the case; and (8) The method by which the MCO verified that the services being investigated were actually provided to the enrollee. G. An MCO shall provide to the Department written disclosure of any affiliation prohibited under 42 CFR §438.610 and take action as directed by the Department. H. An MCO shall provide to the Department written disclosures of information on ownership and control required under 42 CFR §455.104, including: (1) The following information for any individual or corporation with an ownership or control interest in the MCO: (a) For individuals: (i) Name; (ii) Address; (iii) Date of birth; and (iv) Social Security number; and (b) For corporate entities: (i) Name; (ii) Applicable primary business address; (iii) Every business location and applicable P.O. Box address; and (iv) Other tax identification number or any subcontractor in which the MCO has a 5 percent or more interest; (2) Whether the individual or corporation with an ownership or control interest in the MCO: (a) Is related to another person with ownership or control interest in the disclosing entity as a spouse, parent, child, or sibling; or (b) Whether the individual or corporation with an ownership or control interest in any subcontractor in which the MCO has a 5 percent or more interest is related to another person with ownership or control interest in the MCO as a spouse, parent, child, or sibling; (3) The name of any other MCO in which an owner of the MCO has an ownership or control interest; (4) The name, address, date of birth, and Social Security number of any managing employee or agent of the MCO; (5) Disclosures of ownership and control information from MCOs are due at the following times: (a) Upon application; (b) Upon the managed care entity executing the contract with the State; (c) Upon renewal or extension of the contract; and (d) Within 35 days after any change in ownership of the managed care entity. I. An MCO shall report to the Department all overpayments identified and recovered, specifying the overpayments due to fraud. J. An MCO shall report third-party liability collection activities as described in COMAR 10.67.04.18. K. An MCO shall report to the Department the amounts the MCO has cost-avoided and the number of third-party liability cases the MCO has handled. L. An MCO shall notify the Department promptly when it has knowledge of an enrollee’s change of residence or death. M. An MCO shall notify the Department promptly when the MCO receives information about a change in a network provider’s circumstances that may affect the network provider’s eligibility to participate in the Program, including the termination of the provider agreement with the MCO. N. An MCO shall submit all required data, documentation and information in the format specified by the Department. O. An MCO’s chief executive officer, chief financial officer, or directly-reporting authorized employee shall certify to the best of that individual’s information, knowledge, and belief, that any records, data, or other documents requested under regulations are accurate, complete and truthful. P. As directed by the Department’s OIG, the MCO shall submit written reports documenting its Program Integrity efforts, including but not limited to: (1) The dollar amount of losses and recoveries attributable to overpayment, abuse, and fraud; and (2) The number of referrals to the Department’s OIG during the prior State fiscal year. ### Chapter 08 — Maryland Medicaid Managed Care Program: Non-Capitated Covered Services **Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.11 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .02C, D amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .05B amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .06B amended effective October 14, 2013 (40:20 Md. R. 1652); April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .06C amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) **Administrative History:** Regulation .07 amended as an emergency provision effective June 15, 2001 (28:13 Md. R. 1214); amended permanently effective September 17, 2001 (28:18 Md. R. 1621) **Administrative History:** Regulation .07C amended effective November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .07H amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .08A amended effective December 23, 2002 (29:25 Md. R. 1981) **Administrative History:** Regulation .10 amended as an emergency provision effective July 1, 1997 (24:16 Md. R. 1158); amended permanently effective December 29, 1997 (24:26 Md. R. 1759) **Administrative History:** Regulation .10A, C amended effective October 5, 2009 (36:20 Md. R. 1528); October 28, 2013 (40:21 Md. R. 1775) **Administrative History:** Regulation .10C amended as an emergency provision effective July 1, 1998 (25:16 Md. R. 1261); amended permanently effective January 1, 1999 (25:26 Md. R. 1925) **Administrative History:** Regulation .10C amended effective December 25, 2000 (27:25 Md. R. 2281); November 6, 2006 (33:22 Md. R. 1732) **Administrative History:** Regulation .11 repealed effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulations .01—.10 under, Maryland Medicaid Managed Care Program: Specialty Mental Health System, repealed and new Regulations .01—.03 under, Maryland Medicaid Managed Care Program: Non-Capitated Covered Services, adopted effective December 22, 2014 (41:25 Md. R. 1479) **Administrative History:** Regulation .02 amended effective October 26, 2015 (42:21 Md. R. 1301); August 29, 2016 (43:17 Md. R. 955); February 27, 2017 (44:4 Md. R. 253); March 26, 2018 (45:6 Md. R. 319) **Administrative History:** Regulation .02L amended effective May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .02M amended effective May 20, 2019 (46:10 Md. R. 487) **Administrative History:** Regulation .02N adopted effective February 27, 2017 (44:4 Md. R. 253) **Administrative History:** Regulation .03 amended effective October 22, 2018 (45:21 Md. R. 973) **Administrative History:** Regulation .03K amended effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .03N, O amended effective August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Regulation .03P adopted effective August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Regulation .06E amended effective August 28, 2017 (44:17 Md. R. 834) **Administrative History:** Chapter transferred from COMAR 10.09.70 effective November 1, 2019 (46:22 Md. R. 977) **Administrative History:** Regulation .02 amended effective December 27, 2021 (48:26 Md. R. 1112); November 13, 2023 (50:23 Md. R. 1005) **Administrative History:** Regulation .03F amended effective May 18, 2020 (47:10 Md. R. 515) **Administrative History:** Regulation .03I amended effective June 24, 2024 (51:12 Md. R. 620) **Administrative History:** Regulation .03M, N amended effective March 31, 2025 (52:6 Md. R. 267) **Administrative History:** Regulation .03O adopted effective March 31, 2025 (52:6 Md. R. 267) #### Regulation .01 Scope. *COMAR 10.67.08.01* This chapter describes the services that are not the responsibility of the MCOs but are covered by the Department on a fee-for-service basis. #### Regulation .02 Behavioral Health Non-Capitated Covered Services. *COMAR 10.67.08.02* A. An MCO is not responsible for reimbursing for the following substance use disorder services, regardless of diagnosis: (1) Services delivered by a community-based provider as described in COMAR 10.09.80 with the following procedure codes: (2) Substance use disorder services provided to children in an ICF-A with the revenue code 0100, Residential Services, child and adolescent. B. An MCO is not responsible for reimbursing for the following services performed by free-standing laboratories, regardless of diagnosis: (1) Presumptive drug tests; and (2) Definitive drug tests. C. An MCO is not responsible for reimbursing for the laboratory services described in §B of this regulation unless billed by a: (1) Primary care provider; or (2) Other somatic care provider. D. An MCO is not responsible for reimbursing for the following substance use disorder services if the MCO is billed with a primary diagnosis listed in §M of this regulation: (1) Services delivered by an inpatient hospital with the following revenue codes: (2) Services delivered by an outpatient hospital with the following revenue codes: (3) Services delivered by an emergency department with the following revenue codes: E. An MCO is not responsible for reimbursing for mental health services with a primary diagnosis listed in §N of this regulation when the services are provided by a hospital and the services are the result of the treatment of mental health diagnosis. F. An MCO shall be responsible for reimbursing for behavioral health services delivered by the participant’s primary care provider. G. An MCO shall be responsible for reimbursing for somatic services related to gender identity disorder, including gender reassignment surgery. H. An MCO is not responsible for reimbursing the behavioral poisoning diagnoses listed in §P of this regulation in an emergency department setting. I. An MCO is not responsible for services billed by specialty mental health providers listed in COMAR 10.09.59 when the bill includes the specialty behavioral health diagnoses listed in §M or N in the primary diagnosis field. J. An MCO is not responsible for reimbursement of behavioral health crisis services as described in COMAR 10.09.16. K. An MCO is not responsible for behavioral health medications. L. An MCO is not responsible for reimbursing for services billed by a physician related to prescribing buprenorphine or Vivitrol when the following conditions are met: (1) The physician delivering buprenorphine has a DATA 2000 waiver; (2) The physician is not the participant’s primary care provider; (3) The primary diagnosis is substance use disorder; (4) The primary reason for the visit is substance use disorder treatment; and (5) The procedure code listed on the claims is one of the following: M. Table of substance use disorder diagnoses, for dates of service on or after October 1, 2015: N. Table of mental health diagnoses, for dates of service on or after October 1, 2015: O. An MCO is not responsible for services billed by a psychiatrist when the claim includes one of the following primary diagnoses: P. Table of poisoning diagnoses, for dates of service on or after July 1, 2016: #### Regulation .03 Nonbehavioral Health Fee-For-Service Benefits. *COMAR 10.67.08.03* An MCO may not be required to provide any of the following benefits or services that are reimbursed directly by the Department: A. The remaining days of a hospital admission following enrollment in the MCO if the recipient was admitted to the hospital before the date of the recipient's enrollment; B. Long-term care services except for those outlined in COMAR 10.67.06.07B and COMAR 10.67.06.12A; C. Intermediate Care Facilities for Individuals with Intellectual Disabilities or Persons with Related Conditions (ICF/IID) services; D. Personal care services pursuant to COMAR 10.09.20; E. Medical day care services, for adults and children; F. The following HIV/AIDS services: (1) Genotypic, phenotypic, or other HIV/AIDS drug resistance testing used in the treatment of HIV/AIDS, if the service is: (a) Rendered by a Department-approved provider; and (b) Medically necessary; and (2) Viral load testing used in treatment of HIV/AIDS. G. Physical therapy, speech therapy, and occupational therapy services when: (1) The enrollee is younger than 21 years old; and (2) The services are not part of home health services or an inpatient hospital stay; H. Augmentative communication devices; I. All dental services including but not limited to outpatient surgery fees for the facility and general anesthesia. J. Except when a woman has been determined eligible for Medical Assistance benefits under COMAR 10.09.11, an abortion pursuant to COMAR 10.09.02.04G; K. Emergency transportation; L. Transportation services provided through grants to local governments pursuant to COMAR 10.09.19; M. Services provided to members participating in the State's Health Home Program as described in COMAR 10.09.33; N. Applied behavioral analysis (ABA) services as described in COMAR 10.09.28; and O. Abortions performed in accordance with Health-General Article, § 15-103, Annotated Code of Maryland. ### Chapter 09 — Maryland Medicaid Managed Care Program: MCO Dispute Resolution Procedures **Authority:** Health-General Article, §15-103(b)(9)(i)(4), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.03 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01 amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .02 amended effective June 30, 2008 (35:13 Md. R. 1180); February 26, 2018 (45:4 Md. R. 205); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .02A, B amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .02B, C amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .02C amended effective February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .02C amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .02C amended effective April 19, 2010 (37:8 Md. R. 615) **Administrative History:** Regulation .02-1 adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .03 amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .03B amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .03B amended effective October 5, 2009 (36:20 Md. R. 1528); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .03-1 adopted effective April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .03-2 adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .04 adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .04 amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .04B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .05 adopted effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .05 amended effective February 26, 2018 (45:4 Md. R. 205) **Administrative History:** Regulation .05A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .05A amended effective October 5, 2009 (36:20 Md. R. 1528) **Administrative History:** Regulation .05A, B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .05F, G adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred from COMAR 10.09.71 effective November 1, 2019 (46:22 Md. R. 977) **Administrative History:** Regulation .03D adopted effective May 18, 2020 (47:10 Md. R. 515) **Administrative History:** Regulation .04A, D amended effective November 18, 2019 (46:23 Md. R. 1065) **Administrative History:** Regulation .05A amended effective June 13, 2022 (49:12 Md. R. 641) #### Regulation .01 MCO Enrollee Services. *COMAR 10.67.09.01* An MCO shall: A. Maintain a member services unit that operates an enrollee services line at least during normal business hours; B. Operate its enrollee services line as a triage device to handle or properly refer enrollees' questions or complaints; and C. Provide information in the member handbook about how to use the MCO enrollee services line to obtain information and assistance. #### Regulation .02 MCO Enrollee Complaint Process. *COMAR 10.67.09.02* A. An MCO shall have written complaint procedures by which an enrollee who is dissatisfied with the MCO or its network providers, or decisions made by the MCO or a provider, may seek recourse verbally or in writing within the MCO at any time. B. An MCO shall: (1) Submit its written internal complaint procedures to the Department for its approval; (2) Give enrollees any reasonable assistance in completing forms and taking other procedural steps related to a grievance or appeal in a manner consistent with COMAR 10.67.05.01A; (3) Prepare the document describing the MCO’s internal complaint process: (a) In a culturally sensitive manner; (b) At an appropriate reading comprehension level; and (c) In the prevalent non-English languages, identified by the State; (4) Deliver a copy of the MCO’s complaint procedures to each enrollee: (a) With the MCO’s initial contact with a new enrollee; and (b) At any time upon an enrollee’s request; (5) Maintain an accurate and accessible record of grievances and appeals for monitoring by the State and CMS, which includes, at a minimum: (a) A general description of the reason for the appeal or grievance; (b) The date received; (c) The date of each review or, if applicable, review meeting; (d) Resolution at each level of the appeal or grievance, if applicable; (e) Date of resolution at each level, if applicable; and (f) Name of the enrollee for whom the appeal or grievance was filed; and (6) Provide in its written procedures that an enrollee may file appeals and grievances orally or in writing. C. An MCO shall submit for Department approval an internal complaint process detailing the procedures for registering and responding to appeals and grievances in a timely fashion, which: (1) Includes a specific standard for grievance decisions, monitored by the MCO for compliance, directing that: (a) The decision time for emergency medically related grievances may not exceed 24 hours; (b) The decision time for nonemergency medically related grievances may not exceed 5 days; and (c) For administrative grievances, the decision time may not exceed 30 days; (2) Includes participation by the provider, if appropriate; (3) Allows participation by the ombudsman, if appropriate; (4) Ensures the participation of individuals within the MCO who have the authority to require corrective action; (5) Requires documentation of the substance of the grievances and steps taken; (6) Includes a procedure for the aggregation and analysis of appeals and grievance data and use of the data for quality improvement; (7) Includes a documented procedure for reporting: (a) Appeals and grievances received by the MCO to: (i) The provider involved; (ii) Appropriate quality assurance committees and departments within the MCO; (iii) The MCO's consumer advisory board; and (iv) The Department as requested; and (b) The quarterly appeal and grievance analysis performed by the MCO as specified in COMAR 10.67.04.15D(1)(b); (8) Includes a documented procedure for written notification of the MCO's determination: (a) To the enrollee who filed the grievance; and (b) To those individuals and entities required to be notified of the grievance pursuant to §C(7) of this regulation; (9) Ensures that decision makers on appeals and grievances: (a) Were not involved in previous levels of decision-making; (b) Are not subordinates of people involved in previous levels of decision-making; (c) Are healthcare professionals with clinical expertise in treating the enrollee’s condition or disease, if any of the following apply: (i) The appeal is a denial based on lack of medical necessity; (ii) The grievance is regarding denial of expedited resolution of an appeal; or (iii) The appeal or grievance involves clinical issues; and (d) Take into account all comments, documents, records, and other information submitted by the enrollee or their representative, without regard to whether such information was submitted or considered in the initial action. #### Regulation .02-1 Member Complaints — Time Frames for MCOs to Respond to the Department. *COMAR 10.67.09.02-1* An MCO shall: A. Acknowledge an enrollee appeal or grievance reported to it by the Department’s complaint resolution unit within 1 business day; B. Respond to the Department’s request for information regarding disputed nonemergency medical care actions within 3 business days; C. Provide updates in a time frame specified by the Department; D. Provide medical records within 5 days of the request; and E. Provide a corrective action plan upon request and within the time frame specified, but not later than 10 days from the date of the request. #### Regulation .03 MCO Provider Complaint Process. *COMAR 10.67.09.03* A. An MCO shall have a complaint procedure for providers that is: (1) Documented in writing; (2) Disseminated in writing to all of the MCO's providers at the time they join the MCO's provider panel, and furnished to a provider at any time, upon request; and (3) Linked to the MCO's internal quality assurance program. B. An MCO shall include in its provider complaint process at least the following elements: (1) Procedures for registering and responding to provider grievances in a timely fashion, including standards for timeliness that recognize the need for expedited determinations in situations that are time-sensitive, that is, when an enrollee's treatment outcome may be significantly affected by the promptness of treatment, as set forth in Regulation .02C(1)(a) and (b) of this chapter apply; (2) Notification to the provider of an MCO's determination that affects the provider or that provider's patient, which includes a description of how to file an internal appeal with the MCO; (3) Documentation of the substance of complaints and steps taken; (4) Procedures to ensure the timely resolution of the complaint and response by the MCO to the provider; (5) Procedures for the termination or withdrawal of a provider from the MCO's provider panel, including: (a) At least 90 days prior notice to the primary care providers in the MCO's provider panel of the MCO's termination of a specialty services provider when the reason for the termination is unrelated to fraud, patient abuse, incompetency, or loss of licensure status; (b) If possible, at least 90 days prior notice to the primary care providers in the MCO's provider panel of a specialty services provider's withdrawal from the MCO's provider panel; and (c) Notices to primary care providers informing them of the enrollee’s right to change MCOs as described in COMAR 10.67.02.06A(1)(e). (6) Mechanisms to aggregate and analyze appeal and grievance data and to use the data for quality improvement; (7) An appeal process which: (a) Is available when the provider's appeal or grievance is not resolved to the provider's satisfaction, or when the MCO acts to reduce, suspend, or terminate provider's privileges with the MCO; (b) Acknowledges receipt of provider appeals within 5 business days of receipt by the MCO; (c) Allows providers 90 business days from the date of a denial to file an initial appeal; (d) Allows providers at least 15 business days from the date of denial to file each subsequent level of appeal; (e) Resolves appeals, regardless of the number of appeal levels allowed by the MCO, within 90 business days of receipt of the initial appeal by the MCO; (f) Pays claim within 30 days of the appeal decision when a claim denial is overturned; (g) Provides at its final level an opportunity for the provider to be heard by the MCO's chief executive officer, or the chief executive officer's designee; (h) Provides timely written notice to the provider of the results of the internal appeal; and (i) Provides for written notice of the substance of the dispute and the result of the internal appeal to appropriate quality assurance committees and departments within the MCO; and (8) A protocol for transmitting provider appeal and grievance reports and aggregate provider grievance and appeal data to the Department when requested. C. An MCO may not take any punitive action against a provider for utilizing the MCO provider complaint process, for supporting an enrollee's appeal, or for requesting expedited resolution for an enrollee's appeal. D. An MCO or its pharmacy benefits manager shall resolve pharmacy appeals concerning drug pricing within 21 days of the receipt of a request. #### Regulation .03-1 Independent Review Organization (IRO). *COMAR 10.67.09.03-1* For provider disputes involving medical necessity, an MCO shall participate in the IRO process as specified in COMAR 10.67.13. #### Regulation .03-2 Provider Complaints — Time Frames for MCOs to Respond to the Department. *COMAR 10.67.09.03-2* An MCO shall: A. Acknowledge provider grievances within 3 business days; B. Provide findings to the Department within 5 days; and C. Provide a corrective action plan to the Department within 10 days from the date of the request. #### Regulation .04 MCO Actions and Decisions. *COMAR 10.67.09.04* A. For certain services to enrollees that require preauthorization the following conditions apply: (1) For standard authorization decisions, the MCO shall make a determination within 2 business days of receipt of necessary clinical information, but not later than 14 calendar days from the date of the initial request so as not to adversely affect the health of the enrollee; (2) For expedited authorization decisions, the MCO shall make a determination and provide notice no later than 72 hours after receipt of the request for service if the provider indicates or the MCO determines that the standard time frame stated in §A(1) of this regulation could jeopardize: (a) The enrollee’s life; (b) The enrollee’s health; or (c) The enrollee’s ability to attain, maintain, or regain maximum function; (3) For all covered outpatient drug authorization decisions, the MCO shall provide notice by telephone or other telecommunication device within 24 hours of a preauthorization request in accordance with section 1927(d)(5)(A) of the Social Security Act; (4) Standard and expedited authorization decisions may be extended up to 14 calendar days, if the following conditions are met: (a) The enrollee or the provider requests an extension; or (b) The MCO justifies to the Department, upon request, a need for additional information and how the extension is in the enrollee’s interest; and (5) If the MCO successfully justifies extending the standard service authorization decision time frame, the MCO shall: (a) Give the enrollee written notice of the reason for the decision to extend the time frame; (b) Inform the enrollee of the right to file a grievance if he or she disagrees with the extension decision; and (c) Issue and carry out the MCO’s determination as expeditiously as the enrollee’s health condition requires but not later than the date the extension expires. B. Any decision to deny a service authorization request or to authorize a service in an amount, duration, or scope that is less than requested: (1) Shall be made by a health care professional who has appropriate clinical expertise in treating the enrollee's condition or disease; and (2) May not be based solely on diagnosis, type of illness, or condition. C. An MCO shall ensure that compensation to individuals or entities that conduct utilization management activities is not structured to provide incentives for the individual or entity to deny, limit, or discontinue medically necessary services to any enrollee. D. Notices of a decision to deny a standard authorization shall be provided to the enrollee and the requesting provider within 72 hours from the date of determination. E. An MCO shall give an enrollee written notice of any action within the following time frames: (1) At least 10 days before the action for termination, suspension, or reduction of a previously authorized covered service; (2) The notice period is reduced to 5 days if probable enrollee fraud has been verified; (3) By the date of the action for the following: (a) The MCO has factual information confirming the death of an enrollee; (b) A signed written enrollee statement requesting service termination or giving information requiring termination or reduction of services, where the enrollee understands that this is the result of supplying that information; (c) The enrollee's admission to an institution where they are ineligible for further services; (d) The enrollee's address is unknown and mail directed to the enrollee has no forwarding address; (e) The enrollee has been accepted for Medicaid services by another jurisdiction; (f) The enrollee's physician prescribes a change in the level of medical care; or (g) An adverse determination made with regard to the preadmission screening requirements for nursing facility admissions; and (4) As soon as practicable for nursing facility transfers or discharges when: (a) The safety or health of individuals in the facility would be endangered; (b) The enrollee’s health improves sufficiently to allow a more immediate transfer or discharge; or (c) An immediate transfer or discharge is required by the enrollee’s urgent medical needs; and (5) For denial of payment, at the time of any action affecting the claim. F. A notice of adverse action shall: (1) Be in writing; (2) Meet the following requirements: (a) Be translated for enrollees who speak prevalent non-English languages; (b) Include language clarifying that oral interpretation is available for all languages and how to access it; (c) Be written in an easily understood language and format that takes into consideration enrollees with special needs; (d) Be available in alternative formats; and (e) Inform enrollees that information is available in alternative formats and how to access those formats; and (3) Contain the following information: (a) The action the MCO has made or intends to make; (b) The reasons for the action, including the right for the enrollee to be provided upon request and free of charge, reasonable access to and copies of all documents, records, and other information relevant to the MCO’s action, including: (i) Medical necessity criteria; and (ii) Any processes, strategies, or evidentiary standards used in setting coverage limits; (c) The enrollee’s right to request an appeal of the MCO’s action, including information on: (i) Exhausting the MCO’s one level of appeal; and (ii) The right to request a State fair hearing; (d) The procedures for exercising the rights described; (e) The circumstances under which an appeal process can be expedited and how to request it; (f) The enrollee’s right to have benefits continue pending resolution of the appeal; (g) How to request that benefits be continued; and (h) The circumstances under which the enrollee may be required to pay the costs of the services. G. If an MCO does not make an authorization decision within the times specified in §A of this regulation, the untimely decision is considered a denial and thus an adverse action subject to the notice requirements in §§C and E of this regulation. #### Regulation .05 MCO Appeal Process for Enrollees. *COMAR 10.67.09.05* A. An MCO's appeal process shall: (1) Require that an enrollee, or a provider acting on the enrollee’s behalf, file an appeal within 60 days from the date on the MCO’s notice of action; (2) Include procedures for acknowledging receipt of appeals within 5 business days; (3) Permit an enrollee to request an appeal either orally or in writing; (4) Provide that oral requests for appeal are considered the initiation of the appeal to establish the earliest possible filing date; (5) Provide reasonable opportunity to present evidence and allegations of fact or law, in person as well as in writing, and in the case of expedited appeals, the MCO shall inform the enrollee of the limited time available for the enrollee to present this evidence; (6) Provide the case file upon request to the enrollee and the enrollee's representative, free of charge and sufficiently in advance of the resolution time frame for appeals, which includes: (a) Medical records; (b) Other documents and records; and (c) Any new or additional evidence considered, relied upon, or generated by the MCO in connection with the action. (7) Allow a provider or authorized representative acting on behalf of an enrollee to file an appeal with the enrollee’s written consent; (8) Consider the enrollee, the enrollee's representative, or the estate representative of a deceased enrollee as parties to the appeal; (9) Establish and maintain an expedited review process, when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize the enrollee’s life, physical or mental health, or ability to attain, maintain, or regain maximum function; and (10) Ensure that punitive action is not taken against a provider who requests an expedited resolution or supports an enrollee’s appeal. B. Resolution. (1) Except for expedited appeals as described in §C, an MCO shall resolve each appeal and provide notice of resolution, as expeditiously as the enrollee’s health condition requires, and unless extended pursuant to §B(2) of this regulation, within 30 days from the day the MCO receives the appeal. (2) The time frames in §B(1) of this regulation may be extended up to 14 calendar days if: (a) The enrollee requests the extension; or (b) The MCO shows, upon the Department's request, that there is a need for additional information and how the delay is in the enrollee's interest. (3) For any extension not requested by the enrollee, the MCO shall: (a) Give the enrollee written notice; and (b) Make reasonable efforts to give the enrollee verbal notice of the reason for the delay. (4) Continuation of Benefits. The MCO shall continue the enrollee’s benefits pending the outcome of the appeal if all of the following occur: (a) The enrollee timely files for continuation of benefits; (b) The appeal is filed timely, meaning on or before the later of the following: (i) Within 10 days of the MCO mailing the notice of action; or (ii) The intended effective date of the MCO's proposed action; (c) The appeal involves the termination, suspension, or reduction of a previously authorized service; (d) The services were ordered by an authorized provider; and (e) The authorization period has not expired. (5) If the MCO continues or reinstates the enrollee's benefits while the appeal is pending, the benefits shall continue until one of the following occurs: (a) The enrollee withdraws the appeal; (b) The enrollee fails to request a State fair hearing and continuation of benefits within 10 days after the MCO sends the notice of an adverse resolution to the enrollee’s appeal; or (c) A State fair hearing decision adverse to the enrollee is made. (6) If the MCO or State fair hearing officer reverses a decision to deny, limit, or delay services, the MCO shall authorize or provide the disputed services promptly and as expeditiously as the enrollee’s health condition requires but no later than 72 hours of the date the MCO receives the reversal. C. Expedited Appeals. (1) An expedited resolution may be approved when the MCO determines or the provider indicates that taking the time for a standard resolution could seriously jeopardize: (a) The enrollee’s life; (b) The enrollee’s physical or mental health; or (c) The enrollee’s ability to attain, maintain, or regain maximum function. (2) Expedited appeals shall be resolved as expeditiously as the enrollee’s health condition requires but no later than 72 hours after the MCO receives the appeal. (3) If the MCO denies a request for expedited resolution of an appeal, the MCO shall: (a) Transfer the appeal to the standard time frame of not longer than 30 days from the day the MCO receives the appeal with a possible 14-day extension as described in §B(2) of this regulation; and (b) Make reasonable efforts to give the enrollee prompt verbal notice of the denial of expedited resolution and provide a written notice within 2 calendar days. D. Notification. (1) The MCO shall provide written notice of resolution which includes: (a) The results and date of the appeal resolution; (b) The reasons for the action; (c) For decisions not wholly in the enrollee’s favor: (i) The right to request a State fair hearing; (ii) How to request a State fair hearing; (iii) The right to continue to receive benefits pending a hearing; (iv) How to request the continuation of benefits; and (v) A statement that the enrollee may be liable for the cost of any continued benefits if the MCO's action is upheld in a hearing. (2) For notice of an expedited resolution, in addition to requirements listed in §D(1) of this regulation, the MCO shall also make reasonable efforts to provide oral notice of the decision. E. If an MCO fails to adhere to the notice and timing requirements, as described in §§A—D of this regulation, the enrollee is deemed to have exhausted the MCO’s appeals process and may initiate a State fair hearing. F. State Fair Hearing. (1) An enrollee may exercise State fair hearing rights pursuant to the Department’s regulations and State Government Article, §10-201 et seq., Annotated Code of Maryland, subject to the requirements of this regulation. (2) An enrollee may request a State fair hearing for an MCO appeal resolution after first exhausting the MCO’s appeal process by appealing to the Office of Administrative Hearings using the process specified in COMAR 10.01.04. (3) An enrollee shall file for a State fair hearing within 120 days from the date the MCO provides on the written notice of appeal resolution. (4) The parties to an appeal to the Office of Administrative Hearings under this section are the: (a) MCO; (b) Enrollee; and (c) Enrollee’s representative or the personal representative of a deceased enrollee’s estate. (5) The MCO shall provide documentation regarding medical determinations to enrollees and the Office of Administrative Hearings as required by COMAR 10.01.04 and other applicable law. (6) The MCO shall continue the enrollee’s benefits pending the outcome of the State fair hearing if all of the following occur: (a) The enrollee files for continuation of benefits within 10 days of the MCO upholding its action; (b) The State fair hearing request is filed timely, meaning on or before the later of the following: (i) 10 days from the date on the MCO’s notice of appeal resolution; or (ii) The intended effective date of the MCO's proposed action; (c) The State fair hearing involves the termination, suspension, or reduction of a previously authorized service; (d) The services were ordered by an authorized provider; and (e) The authorization period has not expired. (7) If the MCO continues or reinstates the enrollee's benefits while the State fair hearing is pending, the benefits shall continue until one of the following occurs: (a) The enrollee withdraws the State fair hearing; or (b) A State fair hearing decision adverse to the enrollee is issued by the Office of Administrative Hearings. (8) The final decision of the Office of Administrative Hearings is appealable to the circuit court, and is governed by State Government Article, §10-201 et seq., Annotated Code of Maryland, and the Maryland Rules. G. The Department may order an MCO to provide a benefit or service based on its evaluation of the MCO’s action. ### Chapter 10 — Maryland Medicaid Managed Care Program: Sanctions **Authority:** Health-General Article, §15-103(b)(9), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01 and .02 adopted as an emergency provision effective November 8, 1996 (23:25 Md. R. 1730); adopted permanently effective March 10, 1997 (24:5 Md. R. 408) **Administrative History:** Regulation .01A amended effective June 30, 2008 (35:13 Md. R. 1180); December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .01B amended effective June 30, 2008 (35:13 Md. R. 1180) **Administrative History:** Regulation .01B amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .01C repealed effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .01-1 adopted as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); adopted permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Regulation .02 repealed and new Regulation .02 adopted effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Regulation .03 adopted effective February 18, 2002 (29:3 Md. R. 220) **Administrative History:** Regulation .03C amended as an emergency provision effective July 1, 2003 (30:21 Md. R. 1527); amended permanently effective November 10, 2003 (30:22 Md. R. 1580) **Administrative History:** Chapter transferred from COMAR 10.09.73 effective November 1, 2019 (46:22 Md. R. 977) **Administrative History:** Regulation .02B amended effective April 28, 2025 (52:8 Md. R. 359) #### Regulation .01 Sanction by the Department. *COMAR 10.67.10.01* A. If the Department determines, after a sufficient investigation, that an MCO or any agent or employee of the MCO, or any person with an ownership interest in an MCO, or related party of the MCO, has failed to comply with any applicable law, regulation, or contract term, or for other good cause shown, the Department may impose sanctions on the MCO, including but not limited to: (1) Fines; (2) Suspension of further enrollment; (3) Withholding all or part of the capitation payment; (4) Termination of the current HealthChoice Managed Care Organization Agreement; (5) Disqualification from future participation in the Maryland Medicaid Managed Care Program; (6) Orders to provide a benefit or service to enrollees; and (7) Those outlined in 42 CFR §§438.700—438.708, as amended. B. Corrective Action. (1) Subject to §B(2) of this regulation, before imposing a sanction pursuant to §A of this regulation, the Department may permit an MCO an opportunity to take corrective action in accordance with a plan approved by the Department. (2) The MCO shall submit a corrective action plan within a time frame specified by the Department. #### Regulation .01-1 Sanction by Center for Medicare and Medicaid Services (CMS). *COMAR 10.67.10.01-1* The Department shall comply with notification requirements of CMS at 42 CFR §438.730 for sanction determinations as specified in 42 CFR §438.700(b)(1)—(b)(6). #### Regulation .02 Appeal. *COMAR 10.67.10.02* A. From the decisions set forth in §B(1)—(8) of this regulation, an MCO may exercise the appeal rights set forth in §C of this regulation. B. The following Department decisions are appealable by the MCO or MCO applicant: (1) Denial of an entity’s completed application to become an MCO; (2) Decision to terminate the MCO's participation in the Maryland Medicaid Managed Care Program; (3) Decision to impose a fine valued at $50,000 or more on the MCO as described in Regulation .01 of this chapter; (4) Order that the MCO is impaired or in “hazardous financial condition”; (5) An adverse decision by the IRO as described in COMAR 10.67.13.08; (6) The denial of a hepatitis C payment as described in COMAR 10.67.04.19; (7) Overpayments recovered by the Department as described in COMAR 10.67.07.01; and (8) Remittances to the Department as described in COMAR 10.67.04.19-5. C. An MCO may appeal a decision listed in §B of this regulation to the Office of Administrative Hearings as specified in COMAR 10.01.03 and COMAR 10.09.36.09. D. The parties to an appeal to the Office of Administrative Hearings under §C of this regulation are the Department and the MCO. The enrollee is not a party at this hearing. E. The following sanctions shall take effect immediately and are not subject to stay during the pendency of an appeal: (1) Any fines imposed; (2) Any full or partial withhold of the capitation payment; (3) Any remittances to the Department as described in COMAR 10.67.04.19-5; or (4) Any overpayments recovered by the Department as described in COMAR 10.67.07.01. #### Regulation .03 Incentives. *COMAR 10.67.10.03* A. All monies collected from the MCOs as a result of the imposition of a financial sanction shall be deposited in the HealthChoice Performance Incentive Fund. B. This nonlapsing fund shall include all sanctions imposed on the MCOs starting in calendar year 1999. C. The fund shall be used to provide financial incentive awards to the MCOs that meet or exceed specific performance targets as established by the Department, unless otherwise directed by law. ### Chapter 11 — Maryland Medicaid Managed Care Program: Contribution to Graduate Medical Education Costs **Authority:** Health-General Article, §15-103(b)(18), Annotated Code of Maryland **Administrative History:** Effective date: **Administrative History:** Regulations .01—.07 adopted as an emergency provision effective April 7, 1998 (25:9 Md. R. 676); adopted permanently effective June 29, 1998 (25:13 Md. R. 993) **Administrative History:** Regulation .03 amended effective December 25, 2000 (27:25 Md. R. 2281) **Administrative History:** Regulation .08 repealed effective November 1, 1999 (26:22 Md. R. 1692) **Administrative History:** Chapter revised effective December 24, 2001 (28:25 Md. R. 2190) **Administrative History:** Regulation .02B amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Chapter transferred from COMAR 10.09.74 effective November 1, 2019 (46:22 Md. R. 977) #### Regulation .01 Scope. *COMAR 10.67.11.01* This chapter applies to teaching hospitals that provide health care services to recipients enrolled in Maryland Medicaid Managed Care Program MCOs. #### Regulation .02 GME Allocation Payment. *COMAR 10.67.11.02* A. Purpose. GME allocation payments to teaching hospitals are intended to: (1) Reaffirm the Program's historic commitment to preserving graduate medical education at each of the State's teaching hospitals, by maintaining Program payments supporting graduate medical education at levels equivalent to inflation-adjusted FY 1995 expenditures; (2) Promote the training of primary care practitioners; (3) Promote the development of innovative approaches to improve the Program population's access to health care services; and (4) Ameliorate the new funding procedure's impact on MCOs that historically have experienced low utilization of teaching hospitals, by adopting an initial moderate reduction, pursuant to §B(4) of this regulation and COMAR 10.67.05.15, of the amount of GME-allocatable dollars included in teaching hospitals' GME allocation payments during the first 3 years of separate GME funding. B. GME Allocation Payments to Teaching Hospitals. Beginning in FY 1999, the Department shall, on a quarterly basis, pay each teaching hospital a GME allocation payment, calculated as follows: (1) The Department shall calculate the combined dollar amount of payments made by the Program to teaching hospitals during FY 1995, including only those payments attributable to utilization: (a) Of services that, if delivered during the fiscal year during which the GME allocation payment is made, would be included in the Maryland Medicaid Managed Care Program mandatory benefits package established by COMAR 10.67.06; and (b) By recipients who, if the utilization had occurred during the fiscal year in which the GME allocation payment is made: (i) Would have met the eligibility criteria for the Maryland Medicaid Managed Care Program, pursuant to COMAR 10.67.02.01; and (ii) Would not have met the eligibility criteria for the rare and expensive case management program, pursuant to COMAR 10.09.69.03; (2) The amount resulting from the calculation described in §B(1) of this regulation is reduced by the dollar amount of included payments for inpatient hospital services that, if they had been incurred during the fiscal year of the GME allocation payment, would have been subject to avoidance by an MCO pursuant to the stop-loss provisions of COMAR 10.67.04.22; (3) The amount resulting from the calculation described in §B(2) of this regulation is trended forward to adjust for the time differential between the base year (FY 1995) and the contract year; (4) The amount resulting from the calculation described in §B(3) of this regulation is reduced to reflect the managed care discount incorporated into capitation rates pursuant to COMAR 10.67.04.18-1B(2); (5) The amount resulting from the calculation described in §B(4) of this regulation is multiplied by the percentage of Program payments considered, pursuant to COMAR 10.67.04.18-1A(1)—(3), to be attributable to GME; and (6) The amount resulting from the calculation described in §B(5) of this regulation is multiplied by 0.25, to reflect the GME allocation's quarterly payment schedule. ### Chapter 12 — Maryland Medicaid Managed Care Program: Corrective Managed Care **Authority:** Health-General Article, §§15-102.1(b)(9) and 15-103, Annotated Code of Maryland **Administrative History:** Effective date: February 2, 2004 (31:2 Md. R. 82) **Administrative History:** Regulation .02A amended as an emergency provision effective November 1, 2008 (35:24 Md. R. 2069); amended permanently effective February 23, 2009 (36:4 Md. R. 353) **Administrative History:** Regulation .04 amended as an emergency provision effective January 5, 2005 (32:6 Md. R. 634); amended permanently effective April 11, 2005 (32:7 Md. R. 679) **Administrative History:** Regulation .04D amended effective October 5, 2009 (36:20 Md. R. 1528); April 19, 2010 (37:8 Md. R. 615); December 24, 2012 (39:25 Md. R. 1613) **Administrative History:** Regulations .01—.04 repealed and new Regulations .01—.05 adopted effective October 26, 2015 (42:21 Md. R. 1301) **Administrative History:** Regulation .02B amended effective August 29, 2016 (43:17 Md. R. 955) **Administrative History:** Regulation .05B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred from COMAR 10.09.75 effective November 1, 2019 (46:22 Md. R. 977) #### Regulation .01 General. *COMAR 10.67.12.01* A. An MCO shall establish a corrective managed care plan that, at minimum, provides for: (1) The identification of an enrollee that has abused MCO pharmacy benefits; and (2) The enrollment of an enrollee that has been determined to have abused MCO pharmacy benefits in the MCO’s corrective managed care plan. B. Enrollee abuse exists when an enrollee: (1) Has engaged in behaviors identified in COMAR 10.09.24.14-1; or (2) Engages in Medicaid fraud as defined under COMAR 10.09.24.14. #### Regulation .02 Corrective Managed Care Plan. *COMAR 10.67.12.02* A. An MCO’s corrective managed care plan: (1) Shall cover enrollee abuse of medical assistance pharmacy benefits; and (2) May cover enrollee abuse of nonpharmacy medical assistance benefits. B. For all benefit abuse covered by an MCO’s corrective managed care plan, the plan shall: (1) Use the criteria as described in Regulation .01B of this regulation to determine if enrollees have abused benefits; (2) Provide for a medical review of the alleged abuse consistent with §C of this regulation; (3) Provide that an enrollee found to have abused benefits will be enrolled in the program for 24 months; (4) Provide that an enrollee who has been enrolled in a 24 month plan and is subsequently found to have abused MCO benefits shall be enrolled in the plan for an additional 36 months; (5) Provide for the MCO to select any participating provider in the MCO that meets the requirements of COMAR 10.67.05.05A to serve as the enrollee’s primary care, specialty care, and pharmacy providers for enrollees in corrective managed care, as appropriate to the type of benefit the enrollee has been found to have abused; (6) Require an enrollee to obtain prescribed drugs only from a single designated pharmacy provider, which may be any pharmacy or any single branch of a pharmacy chain that participates in the MCO and meets the requirements of COMAR 10.67.05.06B and .07C(2) unless the prescription is: (a) Pursuant to an emergency department visit; (b) Pursuant to hospital inpatient treatment; or (c) A specialty drug as defined in COMAR 10.67.06.04; (7) Provide enrollees determined to have abused benefits the ability to suggest primary care, specialty care, or pharmacy providers; (8) Require the MCO to accept the enrollee’s suggestion referenced in §B(7) of this regulation unless the MCO determines that the recipient’s choice of provider would not serve the enrollee’s best interest in achieving appropriate use of the health care systems and benefits available through the MCO; (9) Provide an enrollee determined to have abused benefits 20 days from the date of the notice to present additional documentation to explain the facts that serve as the basis for the MCO’s determination of benefit abuse, consistent with §D of this regulation; (10) Provide for the designation of a new primary care, specialty care, or pharmacy provider if the enrollee moves out of the service area of the current primary care or pharmacy provider; (11) Provide for prompt reporting to the Department the name of any enrollee enrolled in the MCO’s program, the duration of enrollment, or any change in the duration of enrollment; and (12) Be submitted to the Department for review and approval: (a) Within 60 days of the effective date of this regulation; and (b) Before the implementation of any modification. C. The medical review required in §B(2) of this regulation shall: (1) Be performed by a medical reviewer who is a licensed health care professional; (2) Consider all information that is relevant and available to the MCO, including but not limited to MCO payment records and information secured from any interviews conducted; and (3) Where appropriate, consider records obtained from other sources, including: (a) Providers of medical services; (b) Statistical reports; (c) Outside complaints; (d) Referrals from other agencies; or (e) Any other appropriate sources. D. If an enrollee provides additional information pursuant to §B(9) of this regulation within 20 days: (1) The effective date of the enrollment provided in the notice shall be tolled pending the MCO’s review of the additional information; (2) The MCO shall consider whether the additional information changes the MCO’s determination regarding the appropriateness of the enrollee’s enrollment in corrective managed care; (3) The MCO shall notify the enrollee of its decision whether the MCO is affirming or reversing its determination to enroll the enrollee in corrective managed care; and (4) If the MCO confirms its determination to enroll the enrollee in corrective managed care, the notice shall: (a) Identify the effective date and duration of that enrollment; and (b) Include an explanation of the enrollee’s right to appeal the determination as described in Regulation .05 of this chapter. E. An MCO’s corrective managed care plan may include a process for re-considering, at any interval of time, a decision to enroll an enrollee in the MCO’s corrective managed care plan, if the process entitles the enrollee to appeal the decision pursuant to Regulation .05 of this chapter at the same interval of time. #### Regulation .03 Enrollee Notice. *COMAR 10.67.12.03* The MCO shall provide an enrollee determined to have abused MCO benefits a written notice that includes the following: A. An explanation of the reason or reasons for the determination that the enrollee abused benefits; B. A statement that the enrollee has 20 days to provide: (1) Additional information for the MCO to consider before enrollment will become effective; and (2) The address where the additional information shall be sent; C. A statement that the enrollee will be enrolled in corrective managed care and the effective date and duration of that enrollment; D. An explanation that the effective date will be tolled pending the MCO's review of any additional information the enrollee provides pursuant to §B of this regulation; E. A statement that the enrollee may identify a preference for an assigned primary medical care provider, specialty care provider, or pharmacy; and F. An explanation of the enrollee’s right to appeal the MCO’s determination as described in Regulation .05 of this chapter. #### Regulation .04 Effective Date of Enrollment. *COMAR 10.67.12.04* A. Except as provided in §B of this regulation, the effective date of enrollment shall be 20 days from the date of the notice described in Regulation .03A and B of this chapter, whichever is later. B. If an enrollee determined to have abused benefits appeals the determination, the effective date of the enrollment shall be tolled pending the outcome of the appeal. C. The duration of an enrollee’s enrollment in a plan may not be altered because of changes in how the individual receives medical assistance, including but not limited to a change in the enrollee’s MCO enrollment. #### Regulation .05 Enrollee Appeal. *COMAR 10.67.12.05* A. An enrollee shall have 20 days to appeal an MCO’s determination of benefit abuse. B. Except for the time frame specified in §A of this regulation, an appeal shall be handled as specified in COMAR 10.67.09.05. C. If the appeal results in a hearing, an MCO shall: (1) Attend the hearing; and (2) Provide justification for enrollment in the program. ### Chapter 13 — Maryland Medicaid Managed Care Program: Independent Review Organization (IRO) **Authority:** Health-General Article, §§2-104(b) and 15-103(b), Annotated Code of Maryland **Administrative History:** Effective date: April 28, 2014 (41:8 Md. R. 471) **Administrative History:** Regulation .08B amended effective December 31, 2018 (45:26 Md. R. 1244) **Administrative History:** Chapter transferred from COMAR 10.09.86 effective November 1, 2019 (46:22 Md. R. 977) #### Regulation .01 Scope and Purpose. *COMAR 10.67.13.01* This chapter provides for a complaint resolution process for disputes between managed care organizations (MCOs) and providers regarding adverse medical necessity decision made by MCOs. Pursuant to this chapter, providers that receive an adverse medical necessity decision on claims for reimbursement may submit the adverse decision for review by an Independent Review Organization (IRO) designated by the Department. #### Regulation .02 Definitions. *COMAR 10.67.13.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Adverse decision” means a review determination by a managed care organization that a health care service for which a provider seeks reimbursement is not medically necessary. (2) “Affiliate” means a person who, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with another person. (3) “Case record” means documentation submitted to an independent review organization consisting of: (a) A claim and only the supporting documentation, including medical records, originally submitted to a managed care organization by a provider prior to the managed care organization’s adverse decision on the claim; (b) The managed care organization’s adverse decision; and (c) The managed care organization’s written rationale for the adverse decision. (4) “Claim” means a clean claim as defined in COMAR 31.10.11.02. (5) “Complaint” means an appeal of an adverse decision filed with the independent review organization. (6) “Department” means the Maryland Department of Health. (7) “Expert reviewer” means a physician or other appropriate health care provider who contracts with the independent review organization to conduct a review of a managed care organization’s adverse decision. (8) “Health care service” means a health or medical care procedure or service rendered by a provider including: (a) Testing, diagnosis, or treatment of a human disease or dysfunction; (b) Dispensing of drugs, medical devices, medical appliances, or medical goods for the treatment of a human disease or dysfunction; or (c) Any other care, service, or treatment of disease or injury, the correction of defects, or the maintenance of the physical and mental well-being of human beings. (9) “Independent review organization” means an entity that contracts with the Department to conduct independent review of managed care organizations’ adverse decisions. (10) “Managed care organization (MCO)” has the meaning stated in Health-General Article, §15-101, Annotated Code of Maryland. (11) “Medicaid” means the program administered by the State under Title XIX of the Social Security Act, which provides comprehensive medical and other health-related care for persons. (12) “Medical record” has the meaning stated in Health-General Article, §4-301, Annotated Code of Maryland. (13) “Medically necessary” means a health care service that is: (a) Directly related to diagnostic, preventive, curative, palliative, rehabilitative, or ameliorative treatment of an illness, injury, disability, or health condition; (b) Consistent with currently accepted standards of good medical practice; (c) The most cost-efficient service that can be provided without sacrificing effectiveness or access to care; and (d) Not primarily for the convenience of the consumer, the consumer's family, or the provider. (14) “Provider” means any individual or entity that has a valid provider agreement with a Medicaid managed care organization or is a nonparticipating provider rendering covered Medicaid services to the managed care organization’s enrollees. #### Regulation .03 Use of Independent Review Organizations. *COMAR 10.67.13.03* A. The Department shall procure the services of an IRO to make determinations of medical necessity on provider complaints regarding adverse decisions. B. An IRO that contracts with the Department shall assure, in accordance with its contract with the Department, the: (1) Timeliness and quality of the reviews; (2) Qualifications and independence of the IRO and expert reviewers; and (3) Confidentiality of medical records and review materials, consistent with federal and State laws. C. An IRO designated by the Department shall have the authority to conduct the following functions: (1) Obtaining all case information relative to the complaint from the MCO pursuant to time frames established by the Department; (2) Assigning an expert reviewer for review of an adverse decision; (3) Performing conflicts checks relative to the independent review organization and the expert reviewer assigned to review the adverse decision; (4) Communicating procedural rules, as approved by the Department, and other information regarding appeals to the parties; (5) Rendering a timely final decision in accordance with Regulation .06F of this chapter. #### Regulation .04 Conflicts of Interest Standards for Independent Review Organizations and Expert Reviewers. *COMAR 10.67.13.04* A. An IRO or expert reviewer may not be an affiliate or have a financial, familial or professional relationship with any facility, provider, or organization that has filed a complaint. B. Upon request by the Department, the IRO shall provide to the Department information demonstrating compliance with the requirement in §A of this regulation. #### Regulation .05 Assignment of an Expert Reviewer. *COMAR 10.67.13.05* A. The IRO shall ensure that an expert reviewer: (1) Has appropriate clinical expertise in the treatment of the specific medical condition being reviewed and holds a nonrestricted license as a health care provider in the United States; and (2) Has no history of disciplinary investigations, actions, or sanctions, including loss of staff privileges or participation restrictions that have been taken or are pending by any hospital, governmental agency or unit, or regulatory body. B. Upon request by the Department, the independent review organization shall provide to the Department information demonstrating compliance with the requirements in §A of this regulation. #### Regulation .06 Independent Review. *COMAR 10.67.13.06* A. A provider shall exhaust an MCO’s provider appeal process before filing a complaint with the IRO. B. A provider shall file a complaint with the IRO in the form provided by the IRO not later than 30 calendar days following the date of an MCO’s adverse decision. C. A review of an adverse decision shall be based on the case record. D. The IRO shall, after reviewing the case record, issue a final decision as to whether the health care services that are the subject of the complaint were medically necessary. E. The final decision shall state in writing the factual bases for the decision of the expert reviewer and reference the criteria and standards on which the expert reviewer's decision was based. F. Final decisions shall be rendered within 45 days of submission of the case record, unless the time period is extended by the Department. #### Regulation .07 Payment of Fees and Sanctions. *COMAR 10.67.13.07* A. In the event that a provider’s complaint is unsuccessful, the provider is responsible for paying to the IRO the case review charge established by the Department. B. The case review charge established by the Department shall be based on the contract between the Department and the IRO arrived at through a competitive procurement process. C. An MCO that is determined by the IRO to have improperly denied, either in whole or in part, a provider’s claim on medical necessity grounds is subject to the following: (1) Within 60 calendar days of the date of an adverse decision by an IRO, the MCO shall fully reimburse the provider for claims determined to be medically necessary by the IRO, including any interest owed under Health Insurance Article, §15-1005(f), Annotated Code of Maryland; and (2) Within 60 calendar days of the date of invoice by the IRO, the MCO shall reimburse the IRO the case review charge established by the Department. D. In the event that the unsuccessful party does not pay the IRO within 60 calendar days of the date of the invoice, the Department shall impose penalties as follows: (1) First delinquency: 17 percent of the invoice amount; (2) Second delinquency: 35 percent of the invoice amount; and (3) Third delinquency: 50 percent of the invoice amount plus: (a) For providers, suspension from using the independent case review services for 1 year; or (b) For MCOs, any sanction set forth in COMAR 10.67.10.01A(1)—(5), as determined by the Department. #### Regulation .08 Appeal. *COMAR 10.67.13.08* A. As a prerequisite for participating in the IRO complaint adjudication process, a provider waives all other administrative and judicial appeal rights and accepts the IRO’s decision as final and binding. B. An MCO that receives an adverse decision from an independent review organization may file an appeal in accordance with COMAR 10.67.10.02. ## Subtitle 68 — Community Health Workers ### Chapter 01 — Certification of Community Health Workers **Authority:** Health-General Article, §13-3705, Annotated Code of Maryland **Administrative History:** Effective date: December 30, 2019 (46:26 Md. R. 1166) #### Regulation .01 Definitions. *COMAR 10.68.01.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accreditation” means the approval a community health worker certification training program receives when it has met all the requirements of this chapter. (2) “Accredited community health worker certification training program” means a community health worker certification training program that has been accredited by the Maryland Department of Health. (3) “Applicant” means an individual who applies to the Maryland Department of Health to obtain a community health worker certificate. (4) “Certificate” means a certificate issued by the Department to authorize an individual who meets the requirements of this chapter to represent to the public as a certified community health worker in the State. (5) “Certified community health worker (CCHW)” means an individual who has successfully met the requirements stated in this chapter. (6) “Community health worker (CHW)” has the meaning set forth in Health-General Article, §13-3701, Annotated Code of Maryland. (7) “Core competencies” means: (a) Advocacy and community capacity building skills; (b) Effective oral and written communication skills; (c) Cultural competency; (d) Understanding of ethics and confidentiality issues; (e) Knowledge of local resources and system navigation; (f) Care coordination support skills; (g) Teaching skills to promote healthy behavior change; (h) Outreach methods and strategies; and (i) Understanding of public health concepts and health literacy. (8) “Department” means the Maryland Department of Health. (9) “Professional development activities” means knowledge and skill building opportunities related to the core competencies of community health workers or health principles that may include: (a) Courses; (b) Webinars; (c) Conferences; (d) Workshops; (e) Trainings; or (f) Lectures. (10) “Secretary” means the Secretary of the Maryland Department of Health. #### Regulation .02 Application Procedures. *COMAR 10.68.01.02* A. Qualified Community Health Worker Applicant. A qualified community health worker applicant is an individual who: (1) Has successfully completed a CHW certification training program that is accredited by the Department; or (2) Is eligible to be exempt from the training requirements as set forth in Regulation .03C of this chapter. B. To obtain a community health worker certification, the applicant shall submit to the Department: (1) A completed application on a form provided by the Department; (2) An initial application fee set by the Department in regulation; and (3) Documentation of training or training exemption requirements set forth in this chapter. C. Incomplete Applications. (1) An application is not complete until the Department has received all the materials required under this chapter. (2) If an incomplete application is submitted to the Department, the Department shall: (a) Notify the applicant within 30 calendar days after receipt of the incomplete application; and (b) Specify the materials required to be submitted to complete the application. (3) If the applicant fails to provide the required documentation within 120 calendar days of notification, the Department may: (a) Administratively close the application; or (b) Deny the application, pursuant to the requirements set forth in this chapter. (4) The Department may not refund a fee if an application is administratively closed or denied. (5) An applicant whose application is administratively closed or denied may reapply and submit with the new application documentation in compliance with the requirements of this chapter. #### Regulation .03 Applicant Age, Training, and Experience Requirements. *COMAR 10.68.01.03* A. Age Requirement. An individual seeking community health worker certification shall be 18 years old or older. B. Certification by Completion of a CHW Certification Training Program Accredited by the Department. An applicant for community health worker certification shall: (1) Provide documentation of successful completion of an accredited CHW certification training program as set forth in this chapter; and (2) Possess a high school diploma or GED equivalent. C. Exemption from Training Program Requirements. (1) The Department may exempt an individual occupied as a CHW on October 1, 2018, from the training program requirements set forth in this chapter if the applicant provides documentation of: (a) The completion of a minimum of 2,000 hours of CHW paid or volunteer experience 5 years prior to: (i) October 1, 2018; or (ii) The application date; (b) A minimum of two letters of validation, on a form that the Department requires, from a current or former CHW employer, supervisor, or agency representative that recommend the individual for certification and validate the minimum of 2,000 hours of required experience; and (c) Proficiency in core competencies to be detailed by the applicant and verified in writing by a CHW employer, supervisor, or agency representative. (2) The deadline for submission of an application for exemption from the training program requirements under this section is March 31, 2020. (3) An applicant may request an extension to submit an application, not to exceed 60 days, if: (a) The applicant submits documentation of good cause for an extension; and (b) The Department determines that an extension is reasonable under the circumstances. #### Regulation .04 Action on Application. *COMAR 10.68.01.04* A. Upon review of a completed application, the Department shall: (1) Approve the issuance of a certificate to the applicant if the applicant meets the requirements specified in this chapter; (2) Request additional information to make a determination; or (3) Deny the issuance of a certificate to the applicant. B. Approval for Certification and Issuance of Certificate. (1) If the Department approves the issuance of a certificate to an applicant, the Department shall: (a) Send the applicant a written notice that the applicant is qualified for a certificate; and (b) Issue a certificate to the applicant. (2) The Department shall include on each certificate: (a) The full name of the certificate holder; (b) The dates of issuance and expiration; (c) A serial number; and (d) The signature of the Department representative. C. Denial of Issuance of Certificate. (1) The Department may deny the issuance of a certificate if it determines the applicant has: (a) Not met the age, training, or experience requirements as set forth in this chapter; (b) Failed to remit a fee; or (c) Failed to complete the application form. (2) If the Department denies the issuance of a certificate, the Department shall: (a) Send the applicant written notice of the Department’s denial of the issuance of a certificate, including specification of deficiencies; and (b) Notify the applicant of the right to appeal the denial and to request a formal hearing. (3) An applicant who has been denied the issuance of a certificate by the Department may reapply and submit new application documentation in compliance with the requirements of this chapter. (4) Appealing a Decision to Deny Issuance of a Certificate. An applicant may appeal the decision to deny issuance of a certificate by submitting a request in writing to the Department within 30 calendar days of the date on the notice of denial of certification. (5) If an applicant submits an appeal, the Department, within 60 calendar days, shall: (a) Sustain or reverse the decision on the application; and (b) Provide written notice to the applicant: (i) Indicating whether the decision on the application has been sustained or reversed; and (ii) Providing an explanation of the decision. (6) The Department may not refund a fee if the certification is denied. D. An applicant may request a hearing within 10 calendar days after the date of written notice of the Department’s denial of the issuance of a certificate. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03. #### Regulation .05 Certification Representation. *COMAR 10.68.01.05* An individual shall be certified by the Department before the individual may represent to the public that the individual is a certified community health worker. #### Regulation .06 Requirement to Update Contact Information. *COMAR 10.68.01.06* An individual certified by the Department shall inform the Department, within a reasonable time period, of any changes to the certificate holder’s name and contact information. #### Regulation .07 Expiration and Renewal. *COMAR 10.68.01.07* A. Unless the Department suspends or revokes the certificate, the certificate: (1) Is effective for 2 years from the date issued; and (2) Authorizes the individual to represent to the public that the individual is a certified community health worker. B. At least 90 calendar days before the certificate expires, the Department shall send to the certified community health worker, by electronic or first-class mail to the last known electronic or physical address, a renewal notice that states: (1) The date on which the current certificate expires; (2) Any required renewal submission requirements; (3) The date by which the renewal application shall be received by the Department for the renewal to be issued; and (4) The amount of a renewal fee. C. The certificate holder shall notify the Department if a renewal notice is not received within 60 calendar days before the required renewal date. D. The Department shall renew the certificate of a certified community health worker who: (1) Is eligible to obtain a certificate; (2) Pays to the Department a renewal fee set by the Department in regulation; and (3) Submits to the Department: (a) A renewal application on the form required by the Department; and (b) Satisfactory documentation of completion of 20 hours of a broad range of professional development activities that include a written explanation of acquired knowledge and/or skill application of duties on a form that the Department requires. E. Renewal applications shall be received 30 calendar days prior to the expiration date. #### Regulation .08 Reinstatement of Certificate Due to Nonrenewal. *COMAR 10.68.01.08* A. The Department shall reinstate the certificate of a community health worker who has failed to renew the certificate, if the individual: (1) Has not had the certificate suspended or revoked; (2) Submits to the Department documentation of: (a) Completion of 20 hours of a broad range of professional development activities; and (b) A written explanation of acquired knowledge and/or skill application of duties within the 2-year period immediately preceding the date of renewal; (3) Applies to the Department for reinstatement of the certificate before 2 years after the certificate expires; (4) Pays to the Department a renewal fee set by the Department in regulation; and (5) Meets the requirements for certification set forth by the Department. B. If a CHW is not eligible for reinstatement of a certificate under this chapter, the community health worker may be eligible for the issuance of a certificate by meeting the current requirements for obtaining a new certificate under this chapter. #### Regulation .09 Suspension or Revocation of a Certificate. *COMAR 10.68.01.09* A. The Department may suspend or revoke the certificate of a community health worker who no longer meets the requirements established under this chapter. B. Subject to the hearing provisions of COMAR 10.01.03, the Department may suspend or revoke a certificate if the individual: (1) Fraudulently or deceptively obtains or attempts to obtain a certificate for a community health worker or for another individual; (2) Fraudulently or deceptively uses a certificate; (3) Otherwise fails to meet substantially the standards for certification adopted under this chapter; (4) Is convicted of or pleads guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; (5) Performs the duties of a community health worker while: (a) Under the influence of alcohol; or (b) Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5–101, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; (6) Is disciplined by a licensing or disciplinary authority of any other state or country or convicted or disciplined by a court of any state, territory, or country for an act that would be grounds for suspension or revocation action under this title; (7) Performs the duties of a certified community health worker with an unauthorized person or supervises or aids an unauthorized person in performing the duties of a certified community health worker; (8) Willfully makes or files a false report or record while performing the duties of a certified community health worker; (9) Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report; (10) Commits an act of unprofessional conduct in performing the duties of a community health worker; (11) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the individual is certified and qualified to render because of the individual’s race, sex, creed, color, national origin, marital status, sexual orientation, age, gender identity, or disability; or (12) Fails to maintain on file with the Department a current resident address or employment address or notify the Department when the residency or place of employment changes. C. The Department shall proceed with the suspension or revocation in accordance with the provisions in COMAR 10.01.03. D. The Department shall send written notice of intent to suspend or revoke a certificate to the individual and identify the specific deficiencies. E. Within 30 calendar days after receipt of written notice, the individual may submit to the Department: (1) A written plan by the individual to meet the applicable deficiencies; or (2) A written response setting forth documentation that the individual is meeting and maintaining each of the applicable requirements as set forth in this chapter. F. Based on deficiencies and the individual’s response, if any, the Department may suspend, revoke, or reinstate a certificate. G. Appealing the Decision to Suspend or Revoke a Certificate. (1) An individual may appeal the decision to suspend or revoke a certificate by submitting a request in writing to the Department within 30 calendar days of the date on the notice of suspension or revocation of a certificate. (2) If an individual submits an appeal, the Department, within 60 calendar days, shall: (a) Grant or deny the appeal; and (b) Send individual written notice: (i) Indicating whether the appeal has been granted or denied; and (ii) Providing an explanation of the decision. (3) The Department may not refund a fee if a certification is suspended or revoked. H. An individual may request a hearing within 10 calendar days after receipt of written notice. I. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03. ### Chapter 02 — Community Health Worker Certification Training Programs **Authority:** Health-General Article, §13-3705, Annotated Code of Maryland **Administrative History:** Effective date: December 30, 2019 (46:26 Md. R. 1166) #### Regulation .01 Definitions. *COMAR 10.68.02.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accreditation” means the approval a community health worker certification training program receives when it has met all the requirements of this chapter. (2) “Accredited community health worker certification training program” means a community health worker certification training program that has been accredited by the Maryland Department of Health. (3) “Applicant” means a community health worker training program that applies to the Maryland Department of Health for accreditation. (4) “Community health worker (CHW)” has the meaning set forth in Health-General Article, §13-3701, Annotated Code of Maryland. (5) “Community health worker certification training program” means a training program that has been accredited by the Department. (6) “Department” means the Maryland Department of Health. (7) “Review Committee” means the CHW Training Program Application Review Committee. (8) “Secretary” means the Secretary of the Maryland Department of Health. #### Regulation .02 Application Procedures. *COMAR 10.68.02.02* A. Accreditation Requirements. (1) All CHW certification training programs shall be accredited by the Department. (2) The accreditation shall be issued before an organization may offer a CHW certification training program. B. To obtain accreditation of a CHW certification training program, an organization shall: (1) Obtain the CHW certification training program requirements and a program application from the Department; (2) Submit to the Department an application; and (3) Pay to the Department a fee set by the Department in regulation. C. A CHW certification training program that was in operation on or before October 1, 2018: (1) Will be notified by the Department by certified mail, electronic mail, or MDH website posting of the training program requirements for accreditation set forth in this chapter; (2) Shall comply with the accreditation requirements; and (3) Shall complete an application for accreditation as set forth in this chapter by December 31, 2020. D. A CHW certification training program that trained individuals from October 1, 2018, through December 31, 2020, will be eligible to apply for accreditation for that time period if the training program: (1) Meets the CHW certified training program requirements as set forth in Regulation .03 of this chapter; (2) Submits to the Department an application; (3) Pays to the Department a fee set by the Department in regulation; (4) Becomes an accredited training program; and (5) Provides a list of students who successfully completed the training program during the stated time period. E. The Department may provide technical assistance to CHW certification training programs to meet the requirements set forth in this chapter. F. Incomplete Applications. (1) An application is not complete until the Department has received all the materials required under this chapter. (2) If an incomplete application is submitted to the Department, the Department shall notify the applicant within 30 calendar days after receipt of the incomplete application of the materials that are required to be submitted to complete the application. (3) If the applicant fails to provide the required documentation within 120 calendar days of notification, the Department may: (a) Administratively close the application; or (b) Deny the application, pursuant to Regulation .04D of this chapter. (4) An applicant whose application is administratively closed or denied may reapply and submit with the new application documentation in compliance with the requirements of this chapter. #### Regulation .03 Training Program Requirements. *COMAR 10.68.02.03* A. A CHW certification training program shall: (1) Provide a minimum of 100 hours of instruction; (2) Verify successful completion of an additional supervised 40-hour practicum by a student; (3) Employ a curriculum framework that incorporates, at a minimum, the following core competencies: (a) Advocacy and community capacity building skills; (b) Effective oral and written communication skills; (c) Cultural competency; (d) Understanding of ethics and confidentiality issues; (e) Knowledge of local resources and system navigation; (f) Care coordination support skills; (g) Teaching skills to promote healthy behavior change; (h) Outreach methods and strategies; and (i) Understanding of public health concepts and health literacy; and (4) Include an objective knowledge assessment. B. To complete an accredited CHW certification training program, a student shall successfully meet all requirements of the program. C. Each accredited CHW certification training program shall submit to the Department, as requested, information on the program. D. Without the Department’s approval, an accredited CHW certification training program may not substantively modify an accredited curriculum in a way that results in the curriculum no longer satisfying the core competency requirements. #### Regulation .04 Action on Application. *COMAR 10.68.02.04* A. Application Review. Upon receipt of a completed application, the Department shall: (1) Accept and review applications for accreditation of a CHW certification training program in accordance with a schedule established by the Department and made publicly available; (2) Acknowledge receipt of an application within 10 calendar days after receiving the application; (3) Act on an application within 60 calendar days after the training program has met all the application requirements; and (4) Make a decision regarding application accreditation within 120 calendar days. B. Application Review Committee. (1) Training program applications will be reviewed by a Community Health Worker Training Program Application Review Committee consisting of: (a) A community health worker; (b) A State Community Health Worker Advisory Committee member; (c) A health professions educator with expertise in curriculum development; (d) AN MDH CHW certification program staff member; and (e) As deemed necessary by the Department, an MDH program staff member with subject matter expertise in specialty areas. (2) Individuals will be selected for the Training Program Application Review Committee by the Secretary after review of an application. (3) The Review Committee shall review training program applications to determine whether a training program application meets the requirements set forth in this chapter. (4) The Review Committee shall forward recommendations for accreditation of eligible training programs to the Secretary. (5) The Secretary may approve and direct the Department to accredit a training program if the training program: (a) Satisfies the requirements set forth in this chapter; (b) Pays to the Department a fee set by the Department in regulation; and (c) Participates in an on-site visit, if deemed necessary by the Department. C. Approval of Accreditation Application. If the Department accredits a training program, the Department shall send the applicant written notice that the program is accredited. D. Denial of Accreditation Application. (1) The Department may deny accreditation if it determines that the training program has: (a) Not complied fully with the applicable requirements described in this chapter; (b) Failed to remit a fee; or (c) Failed to complete the application form. (2) If the Department denies accreditation, the Department shall: (a) Send the applicant written notice of the Department’s denial of accreditation, including specific deficiencies; and (b) Notify the applicant of the right to appeal the denial and to request a formal hearing. (3) Within 30 calendar days after receipt of the denial, the training program may submit to the Department either: (a) A written plan that sets forth the steps taken by the program to meet the applicable requirements described in this chapter; or (b) A written response setting forth documentation that the program is meeting and maintaining each of the applicable requirements described in this chapter. (4) Based on the deficiencies and the program’s written response, if any, the Department may approve or deny the application. (5) Appealing a Decision to Deny an Application for Accreditation. A CHW certification training program may appeal the decision to deny an application by submitting the request in writing to the Department within 30 calendar days of the date on the notice of denial of application. (6) If a CHW certification training program submits an appeal, the Department, within 60 calendar days, shall: (a) Grant or deny the appeal; and (b) Provide written notice to the applicant: (i) Indicating whether the appeal has been granted or denied; and (ii) Providing an explanation of the decision. (7) The Department may not refund a fee if an accreditation is denied. (8) An applicant may request a hearing within 10 calendar days after receipt of written notice of the Department’s denial. After receiving the request, the Department shall follow hearing procedures in accordance with COMAR 10.01.03. #### Regulation .05 Expiration and Renewal. *COMAR 10.68.02.05* A. Unless the Department suspends or revokes a CHW certification training program accreditation, the accreditation is effective for 3 years from the date issued. B. At least 90 calendar days before the accreditation expires, the Department shall send to the accredited CHW certification training program by electronic or first-class mail to the last known electronic or physical address a renewal notice that states: (1) The date on which the current accreditation expires; (2) Any required renewal submission requirements; (3) The date by which the renewal application shall be received by the Department for the renewal to be issued; and (4) The amount of a renewal fee. C. The accredited CHW certification training program shall notify the Department if a renewal notice is not received within 60 calendar days of the renewal date. D. The Department shall renew the accredited CHW certification training program that: (1) Is eligible to obtain accreditation; (2) Pays to the Department a renewal fee set by the Department in regulation; and (3) Submits to the Department a renewal application on a form that the Department requires. E. Renewal applications received less than 30 calendar days before the expiration date may not be processed before the expiration date. #### Regulation .06 Reinstatement of Accreditation Due to Nonrenewal. *COMAR 10.68.02.06* A. The Department shall reinstate the accreditation of a CHW certification training program that has failed to renew their accreditation, if the program: (1) Has not had the accreditation suspended or revoked; (2) Applies to the Department for reinstatement of the accreditation before 2 years after the accreditation expires; (3) Pays to the Department a renewal fee set by the Department in regulation; and (4) Meets the requirements for accreditation set forth by the Department. B. If a CHW certification training program is not eligible for reinstatement of accreditation under this chapter, the program may be eligible for accreditation by meeting the current requirements for obtaining a new accreditation under this chapter. #### Regulation .07 Suspension or Revocation of Accreditation of a Training Program. *COMAR 10.68.02.07* A. The Department may suspend or revoke the accreditation from any program which: (1) No longer meets the requirements established under this chapter; (2) Fails to submit in a timely manner: (a) Any information requested by the Department; or (b) Notification of curriculum modification; (3) Falsifies training program information; or (4) Fails to comply with applicable laws or regulations. B. The Department shall proceed with the suspension or revocation in accordance with the provisions in COMAR 10.01.03. C. The Department shall send written notice of the suspension or revocation of accreditation to the training program and identify the specific deficiencies. D. Within 30 calendar days after receipt of written notice, the CHW certification training program may submit to the Department: (1) A written plan by the CHW certification training program to meet the applicable deficiencies; or (2) A written response setting forth documentation that the program is meeting and maintaining each of the applicable requirements described in this chapter. E. Based on deficiencies and the program’s response, if any, the Department may suspend, revoke or reinstate accreditation. F. Appealing a Decision to Suspend or Revoke Accreditation. (1) A CHW certification training program may appeal the decision to suspend or revoke the accreditation by submitting a request in writing to the Department within 30 calendar days of the date on the notice of suspension or revocation of accreditation. (2) If a CHW certification training program submits an appeal, the Department shall within 60 calendar days: (a) Grant or deny the appeal; and (b) Respond in writing to the applicant: (i) Indicating whether the appeal has been granted or denied; and (ii) Providing an explanation of the decision. (3) The Department may not refund a fee if an accreditation is suspended or revoked. G. An applicant may request a hearing within 10 calendar days after receipt of written notice. H. After receiving the request, the Department shall follow hearing procedures in accordance with COMAR 10.01.03. ## Subtitle 69 — Board of Nursing—Licensed Certified Midwives ### Chapter 01 — Licensure of Licensed Certified Midwives **Authority:** Health Occupations Article, §§ 8-101, 8-205, 8-208, 8-508, 8-601, 8-6A-02, 8-6D-01 through 8-6D-15, 8-701, 8-708, and 8-710, Annotated Code of Maryland **Administrative History:** Effective date: February 22, 2026 (52:17 Md. R. 875) #### Regulation .01 Exceptions. *COMAR 10.69.01.01* This chapter does not apply to an individual who: A. Assists at a birth in an emergency; B. Is licensed as a health care practitioner in accordance with the Health Occupations Article, Annotated Code of Maryland whose scope of practice allows the individual to practice certified midwifery; or C. Is a student practicing certified midwifery while engaged in an approved clinical midwifery education experience under the supervision of an individual licensed by the Board as a licensed certified midwife or a licensed nurse certified as a nurse midwife. #### Regulation .02 Definitions. *COMAR 10.69.01.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Accreditation Commission for Midwifery (ACME)” means the accrediting agency for midwifery education programs and institutions, or a successor organization, which is approved by the United States Department of Education. (2) “American College of Nurse Midwives (ACNM)” means the national professional association, or a successor organization, that represents advanced practice midwives, including certified nurse-midwives and certified midwives in the United States (3) “American Midwifery Certification Board (AMCB)” means the national certifying body for candidates in nurse-midwifery and midwifery, or a successor organization, which is approved by the National Commission for Certifying Agencies. (4) “Board” means the Maryland Board of Nursing. (5) “Central Repository” has the meaning stated in Health Occupations Article, §8-303(a), Annotated Code of Maryland. (6) “Clinical practice guidelines” means written standards using guidelines established by: (a) The ACNM in Standards for the Practice of Midwifery, as amended or supplemented; or (b) Any other national certifying body recognized by the Board. (7) “Licensed certified midwife (LCM)” means an individual who has been issued a license by the Board to practice certified midwifery. (8) “Newborn” means an infant in the first 28 days after birth. (9) “Practice certified midwifery” has the meaning stated in Health Occupations Article, §8-6D-01(h), Annotated Code of Maryland. (10) “Physician” means an individual licensed to practice medicine in the State. #### Regulation .03 Qualifications for Applicants for Initial Licensure. *COMAR 10.69.01.03* An applicant for initial licensure as a certified midwife shall: A. Be of good moral character; B. Submit to a criminal history records check in accordance with Health Occupations Article, §8-303, Annotated Code of Maryland; C. Hold a current, valid national certification as a certified midwife from the AMCB; D. Have graduated from a graduate-level midwifery education program accredited by the ACME; and E. Have passed the AMCB certification examination. #### Regulation .04 Requirements for Application for Initial Licensure. *COMAR 10.69.01.04* A. An applicant for initial licensure as a certified midwife shall submit to the Board: (1) A completed application on the form that the Board requires; (2) Written, verified evidence that the applicant has met the requirements of Regulation .03C—E of this chapter; (3) Written, verified evidence that the applicant has submitted to a criminal history records check as required by Regulation .03B of this chapter by submitting: (a) Two sets of fingerprints, as required by the Central Repository and the Federal Bureau of Investigation; and (b) All fees required by the Central Repository and the FBI; (4) Any documentation requested from the applicant by the Board including, but not limited to, official certified or true test court documents and a signed, dated explanation written by the applicant, regarding the facts and circumstances, outcome, and current status of any criminal history record information received by the Board: (a) In accordance with Health Occupations Article, §8-303, Annotated Code of Maryland; (b) In an answer to a question on the Board’s application form; or (c) From any other source; (5) Any additional documentation requested by the Board if the documentation received from the applicant under §A(4) of this regulation is incomplete or insufficient; and (6) A fee for initial licensure as specified under Regulation .13 of this chapter. B. If an application is not complete when initially submitted to the Board by the applicant, the applicant shall have no longer than 12 months from the date the application is received by the Board to: (1) Complete the application; and (2) Provide all information and documents required in §A of this regulation. C. If an applicant fails to provide to the Board a complete application and any additional documentation requested by the Board in §A of this regulation within 12 months from the date the application is received by the Board, then the application: (1) Shall be considered abandoned; and (2) May be destroyed. D. Once an application is deemed abandoned under §C of this regulation, an individual seeking licensure shall: (1) Submit a new application; (2) Meet all of the requirements for licensure; and (3) Pay the required fees in accordance with Regulation .13 of this chapter in effect at the time of re-application. #### Regulation .05 Practice Before Certification. *COMAR 10.69.01.05* A. An individual who has graduated from a graduate level accredited program for midwifery education program approved by the ACME and who has taken the AMCB national certification examination but is waiting for results may practice as a certified midwife graduate before certification if the: (1) Practice is under the supervision of a licensed certified midwife or certified nurse midwife who shall be physically present at the location of service and available to the certified midwife graduate; (2) Supervising midwife and certified midwife graduate execute a written supervision agreement on the form required by the Board; and (3) Certified midwife graduate files with the Board a copy of the: (a) Admission slip to the Board-approved certification examination; and (b) Signed supervision agreement. B. A certified midwife graduate who has entered into a supervision agreement under this regulation shall immediately notify the Board and the supervising midwife of the results of the AMCB certification examination. C. A certified midwife graduate may not continue to practice under a supervision agreement under this regulation for more than 1 year from the filing of all documents required under §A(3) of this regulation, or after the denial of AMCB certification, whichever occurs first. #### Regulation .06 Term and Renewal of License. *COMAR 10.69.01.06* A. A license issued under this regulation authorizes the licensee to practice licensed certified midwifery while the license is active. B. Unless renewed, a license expires on October 28 of every even-numbered year, except that an initial license shall not expire within 180 days of the date of issuance. C. Before a license expires, the licensed certified midwife may renew the license for an additional 2-year term if the licensed certified midwife: (1) Is otherwise entitled to be licensed; (2) Pays to the Board the renewal fee specified in Regulation .13 of this chapter; and (3) Submits to the Board: (a) A renewal application on the form that the Board requires; (b) Satisfactory evidence of current national certification as a certified midwife by AMCB; and (c) If required to submit to a criminal history records check in accordance with § C of this regulation, evidence of submission to a criminal history records check as required by the Board. D. A licensed certified midwife shall submit to a criminal history records check in order to renew a license in accordance with the following schedule: (1) In 2025—all applicants with an August or September birth month; (2) In 2026—all applicants with a September or October birth month; (3) In 2027—all applicants with an October or November birth month; (4) In 2028— all applicants with a November or December birth month; (5) In 2029—all applicants with a December or January birth month; (6) In 2030—all applicants with a January or February birth month; (7) In 2031—all applicants with a February or March birth month; (8) In 2032—all applicants with a March or April birth month; (9) In 2033—all applicants with an April or May birth month; (10) In 2034—all applicants with a May or June birth month; and (11) In 2035—all applicants with a June or July birth month. (12) In 2036—all applicants with a July or August birth month; E. The Board may grant a 30-day extension beyond a license’s expiration date so that the license may be renewed before it expires. #### Regulation .07 Change in Name or Address. *COMAR 10.69.01.07* A licensed certified midwife shall provide written notice to the Board, on the form required by the Board, within 60 days of a change of: A. Name, along with legal documentation of the change; or B. Address. #### Regulation .08 Required Documentation. *COMAR 10.69.01.08* A. A licensed certified midwife who provides clinical midwifery services across the reproductive lifespan in accordance with this subtitle shall: (1) Maintain a health record for each client; (2) In the case of a transfer of care to another provider or a facility, transfer the client’s health records with the client; and (3) Comply with applicable State laws and regulations governing the creation and maintenance of health care records. B. A licensed certified midwife who provides clinical midwifery services shall have available at all times for examination by the Board, written clinical practice guidelines that cover all aspects of care, practice, and quality assurance, including but not limited to: (1) A plan for emergency consultation; (2) A plan for transfer of care; and (3) A plan for admission of the client or newborn to a hospital within the client’s geographic area. #### Regulation .09 Scope of Practice. *COMAR 10.69.01.09* A. A licensed certified midwife may perform the following functions: (1) Independent management of clients appropriate to the skill and educational preparation of the licensed certified midwife and the licensed certified midwife's clinical practice guidelines; (2) Consultation or collaboration with a physician or other health care provider as needed; and (3) Referral of clients with complications beyond the scope of practice of the licensed certified midwife to another licensed health care practitioner, including a licensed physician. B. A licensed certified midwife shall keep a record of all cases attended. C. A licensed certified midwife has the right and obligation to refuse to perform any delegated medical act, oral or written, if, in the licensed certified midwife’s judgment, it is unsafe or an invalidly prescribed medical act or beyond the competence of the licensed certified midwife, in which case the licensed certified midwife shall immediately notify the delegating physician. D. Subject to the hearing provisions of COMAR 10.01.03, the Department may suspend or revoke a certificate if the individual: (1) Fraudulently or deceptively obtains or attempts to obtain a certificate for a community health worker or for another individual; (2) Fraudulently or deceptively uses a certificate; (3) Otherwise fails to meet substantially the standards for certification adopted under this chapter; (4) Is convicted of or pleads guilty or nolo contendere to a felony or to a crime involving moral turpitude, whether or not any appeal or other proceeding is pending to have the conviction or plea set aside; (5) Performs the duties of a community health worker while: (a) Under the influence of alcohol; or (b) Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, §5–101, Annotated Code of Maryland, or other drug that is in excess of therapeutic amounts or without valid medical indication; (6) Is disciplined by a licensing or disciplinary authority of any other state or country or convicted or disciplined by a court of any state, territory, or country for an act that would be grounds for suspension or revocation action under this title; (7) Performs the duties of a certified community health worker with an unauthorized person or supervises or aids an unauthorized person in performing the duties of a certified community health worker; (8) Willfully makes or files a false report or record while performing the duties of a certified community health worker; (9) Willfully fails to file or record any report as required under law, willfully impedes or obstructs the filing or recording of the report, or induces another to fail to file or record the report; (10) Commits an act of unprofessional conduct in performing the duties of a community health worker; (11) Refuses, withholds from, denies, or discriminates against an individual with regard to the provision of professional services for which the individual is certified and qualified to render because of the individual’s race, sex, creed, color, national origin, marital status, sexual orientation, age, gender identity, or disability; or (12) Fails to maintain on file with the Department a current resident address or employment address or notify the Department when the residency or place of employment changes. E. The Department shall proceed with the suspension or revocation in accordance with the provisions in COMAR 10.01.03. F. The Department shall send written notice of intent to suspend or revoke a certificate to the individual and identify the specific deficiencies. G. Within 30 calendar days after receipt of written notice, the individual may submit to the Department: (1) A written plan by the individual to meet the applicable deficiencies; or (2) A written response setting forth documentation that the individual is meeting and maintaining each of the applicable requirements as set forth in this chapter. H. Based on deficiencies and the individual’s response, if any, the Department may suspend, revoke, or reinstate a certificate. I. Appealing the Decision to Suspend or Revoke a Certificate. (1) An individual may appeal the decision to suspend or revoke a certificate by submitting a request in writing to the Department within 30 calendar days of the date on the notice of suspension or revocation of a certificate. (2) If an individual submits an appeal, the Department, within 60 calendar days, shall: (a) Grant or deny the appeal; and (b) Send individual written notice: (i) Indicating whether the appeal has been granted or denied; and (ii) Providing an explanation of the decision. (3) The Department may not refund a fee if a certification is suspended or revoked. J. An individual may request a hearing within 10 calendar days after receipt of written notice. K. When the Department receives the request, it will follow hearing procedures in accordance with COMAR 10.01.03. #### Regulation .10 Compliance. *COMAR 10.69.01.10* The certified midwife shall develop and comply with clinical practice guidelines as defined in Regulation .01B of this chapter. #### Regulation .11 Prescribing and Dispensing of Substances by a Licensed Certified Midwife. *COMAR 10.69.01.11* A. Pursuant to Health Occupations Article, §8-6D-01, Annotated Code of Maryland, a licensed certified midwife may: (1) Prescribe substances commonly used in the practice of midwifery; and (2) Prescribe controlled dangerous substances on Schedules II-V under Criminal Law Article, §§5-403—5-406, Annotated Code of Maryland, commonly used in the practice of midwifery; and (3) Dispense substances prescribed in accordance with §A(1)—(2)of this regulation in the course of treating a client at a: (a) Nonprofit medical facility or clinic; (b) Health center operating on the campus of an institution of higher education; (c) Public health facility; (d) Medical facility under contract with a State or local health department; or (e) Facility funded with public funds. B. A licensed certified midwife who personally prepares and dispenses a drug in the course of treating a client as authorized under §A(3) of this regulation shall: (1) Comply with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland; (2) Record the dispensing of the prescription drug on the client's chart; (3) Allow the Office of Controlled Substances Administration to enter and inspect the licensed certified midwife's office at all reasonable hours in accordance with Health Occupations Article, §8-508, Annotated Code of Maryland ; and (4) Except for starter dosages or samples dispensed without charge: (a) Provide the client with a written prescription; (b) Maintain prescription files; and (c) Maintain a separate file for Schedule II prescriptions for a period of at least 7 years. (5) A licensed certified midwife may personally prepare and dispense a starter dosage of any drug the licensed certified midwife is authorized to prescribe to a client if: (a) The starter dosage complies with the labeling requirements of Health Occupations Article, §12-505, Annotated Code of Maryland; (b) No charge is made for the starter dosage; and (c) The licensed certified midwife enters an appropriate record in the client’s medical record. #### Regulation .12 Unlawful Practices. *COMAR 10.69.01.12* Pursuant to Health Occupations Article, Title 8, Subtitle 6D, Annotated Code of Maryland, an individual may not: A. Practice licensed certified midwifery unless licensed under this subtitle or otherwise permitted by law to engage in those activities; B. Use the title “certified midwife” or the abbreviation “CM” unless licensed by the Board with the intent to represent that the individual practices licensed certified midwifery in the State; C. Represent to the public by title, description of service, method, procedure, or otherwise that the individual is authorized to practice licensed certified midwifery in this State unless licensed under this subtitle; or D. Advertise in a manner that is unreasonable, misleading, or fraudulent. #### Regulation .13 Licensure Fees. *COMAR 10.69.01.13* A. The fees listed in this regulation are nonrefundable. B. The fees are as follows: (1) Initial application fee—$150; (2) Biennial renewal fee—$120; (3) Biennial reinstatement fee—$70; (4) Verification of licensure fee—$45; and (5) Returned check fee—$30. C. Health Care Practitioner User Fee. (1) In addition to a license fee, each licensed certified midwife shall pay a non-refundable health care practitioner user fee assessed by the Maryland Health Care Commission in accordance with Health-General Article, §19-111(b)(4), Annotated Code of Maryland. (2) The health care practitioner user fee shall be: (a) In addition to the licensing fee paid to the Board; and (b) Collected with the application for an initial or renewal license. (3) The amount of the assessed health care practitioner user fee shall be double the amount of the annual health care practitioner user fee for biennial licensure. (4) The Board shall: (a) Account for the health care practitioner user fees; and (b) Transfer the health care practitioner user fees to the Maryland Health Care Commission on a quarterly basis. ### Chapter 02 — Delegation of Technical Acts by a Licensed Certified Midwife **Authority:** Health Occupations Article, §§ 8-101, 8-205, 8-208, 8-508, 8-601, 8-6A-02, 8-6D-01 through 8-6D-15, 8-701, 8-708, and 8-710, Annotated Code of Maryland **Administrative History:** Effective date: February 22, 2026 (52:17 Md. R. 875) #### Regulation .01 Scope. *COMAR 10.69.02.01* A. This chapter governs the delegation of other technical tasks by a licensed certified midwife to an assistant not otherwise authorized under Health Occupations Article, Annotated Code of Maryland. B. This chapter may not be construed: (1) As establishing the licensure, certification, or registration of assistants by the Board; (2) To apply to an individual who is licensed, certified, or registered by a health occupations regulatory board, or health occupation students, acting pursuant to Health Occupations Article, Annotated Code of Maryland; and (3) To mean that this chapter overrides, or is to be used in lieu of, more stringent regulations, policies, and procedures established by State licensure or certification requirements. #### Regulation .02 Definitions. *COMAR 10.69.02.02* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) “Assistant” means an individual: (a) To whom only routine technical tasks are delegated by a licensed certified midwife; (b) Who is trained; and (c) Who is not licensed, certified, registered, or otherwise authorized by law by the Board, or any other State health occupations board, to practice any health occupation in the State. (2) “Asynchronous telehealth interaction” has the meaning stated in Health Occupations Article, §1-1001(b), Annotated Code of Maryland. (3) “Board” means the Maryland Board of Nursing. (4) “Delegating Licensed Certified Midwife (LCM)” means a licensed certified midwife who directs an assistant to perform technical tasks. (5) “Direct supervision” means oversight exercised by a delegating licensed certified midwife who is: (a) Personally treating the client; and (b) In the physical presence of the client and the assistant. (6) “Licensed Certified Midwife (LCM)” means an individual who has been issued a license by the Board to practice certified midwifery in accordance with COMAR 10.69.01. (7) Mechanical Act. (a) “Mechanical act” means an act which does not require professional judgment, medical or pharmaceutical training, or discretion. (b) “Mechanical act” does not include: (i) Selecting a drug; (ii) Labeling; (iii) Measuring or calculating dosages; (iv) Substituting one drug for another, including substituting a generic or brand drug for the prescribed drug; (v) Substituting one dosage form of a drug for another; (vi) Altering the route of administration; or (vii) Counseling client. (8) “On-site supervision” means oversight exercised by a delegating licensed certified midwife who is: (a) Present at the same site as the assistant and the client; and (b) Able to be immediately available in person during the assistant’s performance of a delegated act; or (c) In the context of a synchronous telehealth interaction, able to be immediately available via secure telecommunications technology to the telehealth visit during the assistant’s performance of a delegated act; or (d) In the context of an asynchronous telehealth interaction, is able to review the assistant’s work and interact with the assistant before communication with the client. (9) “Site” means any facility or location, including those defined in Health-General Article, §§19-114 and 19-3B-01(b), Annotated Code of Maryland, used for the delivery of health services. (10) “Synchronous telehealth interaction” has the meaning stated in Health Occupations Article, §1-1001(d), Annotated Code of Maryland. (11) “Technical task” means a routine clinical act or task that does not require clinical or midwifery judgment and is performed with supervision as specified within this chapter. (12) “Trained” means possessing the knowledge, skills, and abilities, as determined by the delegating licensed certified midwife, to perform delegated technical tasks. #### Regulation .03 Standards for Delegation. *COMAR 10.69.02.03* A. A licensed certified midwife who delegates shall: (1) Assess the risk to the client and the outcome of the delegated acts; (2) Delegate only those technical tasks that are customary to the practice of a licensed certified midwife; (3) Delegate only those technical tasks for which the assistant has been trained; (4) Be responsible for the acts of the assistant; (5) Supervise the assistant in accordance with this chapter; and (6) If dispensing prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland, perform a final check of the prescription medication before it is provided to the client. B. The responsibility for the delegated act cannot be transferred from the delegating licensed certified midwife to another licensed certified midwife, or to another licensed health care provider that is authorized to delegate clinical and technical tasks, without: (1) The expressed consent of the other licensed certified midwife or licensed health care provider; and (2) Informing the assistant. #### Regulation .04 Scope of Delegation to an Assistant. *COMAR 10.69.02.04* A. A licensed certified midwife may not delegate technical tasks to an assistant which shall, by law or regulation, be performed only by an individual that is required to be licensed, certified, registered, or otherwise recognized pursuant to any State laws. B. A licensed certified midwife may delegate technical tasks, consistent with the approved policies and procedures of the site, in the following categories: (1) Surgical technical tasks that the delegating licensed certified midwife directly orders while present and personally performing the surgery in the same surgical field; and (2) Nonsurgical technical tasks while the assistant is under the delegating licensed certified midwife’s direct supervision or on-site supervision. C. Except as provided in §§B(1) and D of this regulation, a licensed certified midwife shall provide a minimum of on-site supervision when delegating technical tasks to an assistant, including, but not limited to, the following: (1) Client preparation for physical examination; (2) Client history interview; (3) Collecting and processing specimens, such as performing phlebotomy, inoculating culture media, pregnancy tests; dipstick and microscopic urinalysis, and microbiology including rapid streptococcal testing and throat cultures; (4) Preparing and performing laboratory tests under State and Clinical Laboratory Improvement Amendments regulations; (5) Clinical tests; (6) Transmitting prescriptions to a pharmacy; (7) Preparing and administering oral drugs; (8) Establishing a peripheral intravenous line; and (9) Preparing and administering injections including small amounts of local anesthetics if provided either: (a) Intradermal; (b) Subcutaneous; or (c) Intramuscular in the deltoid, gluteal, or vastus lateralis. D. When delegating injecting intravenous drugs or contrast materials to an assistant, a licensed certified midwife shall provide direct supervision. E. A licensed certified midwife who is dispensing prescription medication under Health Occupations Article, Title 8, Annotated Code of Maryland may delegate only mechanical acts involved in dispensing a drug. F. A licensed certified midwife may not delegate to an assistant any act that requires the exercise of clinical judgment by a licensed certified midwife, including, but not limited to: (1) Conducting physical examinations; (2) Administering any form of anesthetic agent or agent of conscious sedation other than topical anesthetics or small amounts of local anesthetics; (3) Initiating independently any form of treatment, except for cardiopulmonary resuscitation, or other forms of emergency treatment authorized to be performed by non-clinicians under State law; (4) Establishing a diagnosis or giving clinical advice; and (5) Providing physical therapy. #### Regulation .05 Prohibited Conduct and Penalties. *COMAR 10.69.02.05* A. An assistant acting beyond the scope of this chapter may be: (1) Considered to be engaged in the unlicensed practice of licensed certified midwifery or any other health occupation regulated by the State; and (2) Subject to all applicable fines and penalties in accordance with Health Occupations Article, §§8-701 et seq., Annotated Code of Maryland and applicable regulations, or any other applicable provision of Health Occupations Article, Annotated Code of Maryland. B. A delegating licensed certified midwife, through either act or omission, facilitation, or otherwise enabling or forcing an assistant to practice beyond the scope of this chapter, may be subject to discipline as set forth in Health Occupations Article, §8-6D-10, Annotated Code of Maryland. C. A delegating licensed certified midwife may not: (1) Require an assistant to perform a delegated technical task; or (2) Permit an assistant to delegate any act to another individual. #### Regulation .06 Enforcement. *COMAR 10.69.02.06* The Board shall conduct any necessary investigation regarding the failure to comply with the requirements of Health Occupations Article, Title 8, Annotated Code of Maryland, and this chapter, and it may refer any complaint or investigation to any other appropriate licensing or regulatory authority in accordance with applicable laws and regulations. ### Chapter 03 — Code of Ethics **Authority:** Health Occupations Article, §§ 8-101, 8-205, 8-208, 8-508, 8-601, 8-6A-02, 8-6D-01 through 8-6D-15, 8-701, 8-708, and 8-710, Annotated Code of Maryland **Administrative History:** Effective date: February 22, 2026 (52:17 Md. R. 875) #### Regulation .01 Definitions. *COMAR 10.69.03.01* A. In this chapter, the following terms have the meanings indicated. B. Terms Defined. (1) Abandonment. (a) “Abandonment” means failure to provide or make reasonable arrangements for the continuation of care for a client in need of immediate care or failure to provide reasonable notice to a facility or practice under circumstances that seriously impair the delivery of clinical care to clients. (b) “Abandonment” does not include the declining by a licensed certified midwife of employer-stipulated mandatory overtime. (2) “Board” means the Board of Nursing. (3) “Client” means a patient, resident, or recipient of care. (4) “Electronic devices” means, but is not limited to, any of the following: (a) Telephones with recording and picture-taking ability; (b) Digital cameras or any other device that can record pictures and data; (c) Facsimile machines, photocopiers, and scanners for copying; and (d) Recording devices. (5) “Licensed certified midwife (LCM)” means an individual who has been issued a license by the Board to practice certified midwifery in accordance with COMAR 10.69.01. (6) Social Media. (a) “Social media” means any form of electronic communication. (b) “Social media” includes but is not limited to communication by use of websites or other electronic applications for social networking, commentary, and blogging through which users create online communities to share information, ideas, personal messages, and other content such as videos. #### Regulation .02 Ethical Responsibilities. *COMAR 10.69.03.02* A. A licensed certified midwife shall: (1) Provide services with respect for human dignity and the uniqueness of a client unrestricted by consideration of social or economic status, religious affiliation, personal attributes, race, sexual orientation, gender identity, or the nature of health problems; (2) Safeguard a client's right to privacy by maintaining confidentiality of information; (3) Act to safeguard a client and the public if health care and safety are affected by the incompetent, unethical, or illegal practice of any person; (4) Promptly report a breach of confidentiality or privacy; (5) Assume responsibility and accountability for individual clinical judgments and actions; (6) Maintain competence in licensed certified midwifery; (7) Exercise informed judgment and use individual competence and qualifications as criteria in seeking consultation, accepting responsibilities, and when delegating; and (8) Inform the Board regarding unethical conduct by another licensed certified midwife. B. A licensed certified midwife may not, when acting in the capacity or identity of a licensed certified midwife: (1) Knowingly participate in or condone dishonesty, fraud, deceit, or misrepresentation; (2) Engage or participate in an action that violates or diminishes the civil or legal rights of a client; (3) Perform new techniques and procedures without adequate education and practice; (4) Assume duties and responsibilities in the practice of licensed certified midwifery without adequate preparation or without maintaining competency; (5) Practice clinically if unfit to perform procedures or make decisions because of physical or mental impairment, including, but not limited to, the effects of prescription drugs; (6) If engaged in research, coerce or pressure a subject to participate or continue to participate in the research; or (7) Abandon a client. C. A licensed certified midwife may not engage in behavior that dishonors the profession whether or not they are acting in the capacity or identity of a licensed certified midwife, including, but not limited to: (1) Verbal abuse, including use of racial or ethnic slurs, directed toward a coworker, employer, Board staff member, client, or client’s family member; (2) Physically abusing, threatening, or intimidating a coworker, employer, Board staff member, client, or client’s family member; (3) Deceiving, defrauding, or stealing from a coworker, employer, client, or client’s family member; (4) Diverting any medication or providing false or misleading information to an authorized prescriber or a pharmacist to obtain or attempt to obtain any medication; (5) Knowingly employ another person to practice, engage in, or attempt to practice, or engage in an occupation or profession licensed by the Board if the employee is not licensed to do so in accordance with Health Occupations Article, Title 8, Annotated Code of Maryland; (6) Performing acts beyond the authorized scope of the level of midwifery practice for which the individual is licensed; (7) Obtaining or copying any part of a client’s health record for purposes other than: (a) Providing health care to the client; (b) Conducting quality improvement activities; (c) Complying with legal requirements such as a subpoena; or (d) Allowing a midwifery student to use records for educational purposes if client identification has been redacted or disguised; (8) Using, possessing, supplying, administering, or attempting to use, possess, supply, or administer prescription drugs or controlled dangerous substances without valid clinical indication; (9) Reporting for employment under the influence of alcohol or a controlled dangerous substance or submitting a pre-employment sample that is positive for alcohol or a controlled dangerous substance without having provided evidence of valid prescriptions for all controlled dangerous substances in the sample; (10) Reporting for employment under the influence of an illicit drug or submitting a pre-employment sample that is positive for an illicit drug; (11) Using the power, influence, or knowledge, inherent in or obtained during the provider-client relationship, for the licensee’s personal gratification or benefit; (12) Engaging in unprofessional or immoral conduct; (13) Misrepresenting or concealing a material fact in obtaining a license, renewing a license, or reinstating a license; or (14) Committing an act of moral turpitude, dishonesty, or corruption when the act directly or indirectly affects the health, welfare, or safety of the citizens of this State, and, if the act constitutes a crime, conviction thereof in a criminal proceeding is not a condition precedent to disciplinary action. D. A licensed certified midwife may not engage in sexual misconduct. Sexual misconduct includes, but is not limited to: (1) Sexual behavior with a client in the context of a professional evaluation, treatment, procedure, or service to the client, regardless of the setting in which the professional service is rendered; (2) Sexual behavior with a client under the pretext of diagnostic or therapeutic intent or benefit; (3) Solicitation of a sexual relationship, whether consensual or nonconsensual, with a client; (4) Sexual advances toward, or the request of sexual favors from, a coworker, student, employer, client, or client’s family member; (5) Discussion of nontherapeutic sexual matters while treating a client; (6) Taking photographs of a client for a sexual purpose; (7) Sexual harassment of a coworker, student, employer, client, or client’s family member; (8) Sexual contact with an incompetent or unconscious client; (9) Intentionally exposing any of the licensee's sexual body parts; and (10) Intentionally exposing any of the client’s sexual body parts for a nontherapeutic purpose. E. Electronic devices may not be used to record medical records and take pictures or videos of clients without written client authorization. F. A licensed certified midwife: (1) May not make use of electronic devices and social media to transmit or place any client information online; and (2) Shall adhere to the following principles for the use of electronic devices and social media: (a) Every licensed certified midwife has an obligation to understand the nature, benefits, and consequences of the use of electronic devices and participating in social media networking; (b) Licensed certified midwives are bound to observe ethically prescribed client-provider boundaries online as in any other setting; (c) Client information shall be maintained in separate encrypted and secured files on personal computers and online; (d) A licensed certified midwife has an obligation to report any electronically generated material that could harm a client’s privacy rights; and (e) The standards of professionalism are the same when using electronic devices and social media as in any other circumstance. #### Regulation .03 Penalties. *COMAR 10.69.03.03* Violation of this chapter may result in the Board taking disciplinary action against a licensed certified midwife pursuant to Health Occupations Article, §8-6D-10, Annotated Code of Maryland.